Table of Contents

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

Form 10-Q

(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the Quarterly Period Ended June 30, 2020

OR

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF SECURITIES EXCHANGE ACT OF 1934

For the transition period from          to          

Commission file number 001-37809

NeuroBo Pharmaceuticals, Inc.

(Exact name of Registrant as specified in its charter)

Delaware

47-2389984

(State or other jurisdiction of incorporation or organization)

(IRS Employer Identification No.)

200 Berkeley Street, Office 19th Floor

Boston, Massachusetts

02116

(Address of principal executive offices)

(Zip Code)

(857) 702-9600

(Registrant’s telephone number, including area code)

Not Applicable

(Former name, former address and former fiscal year, if changed since last report)

Securities registered pursuant to Section 12(b) of the Act:

Title of Each Class

Trading Symbol(s)

Name of Each Exchange On Which Registered

Common stock, $0.001 par value

NRBO

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes    No  

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes      No  

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer  

Accelerated filer  

 

 

Non-accelerated filer  

Smaller reporting company  

Emerging growth company  

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes    No  

The number of outstanding shares of the registrant’s common stock, $0.001 par value, as of August 11, 2020 was 16,427,307.


Table of Contents

NeuroBo Pharmaceuticals, Inc.

FORM 10-Q

INDEX

PART I

FINANCIAL INFORMATION

ITEM 1:

Financial Statements (unaudited):

Condensed Consolidated Balance Sheets as of June 30, 2020 (unaudited) and December 31, 2019

3

Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and six months ended June 30, 2020 and 2019 (unaudited)

4

Condensed Consolidated Statements of Changes in Stockholders’ Equity (Deficit) for the three and six months ended June 30, 2020 and 2019 (unaudited)

5

Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2020 and 2019 (unaudited)

6

Notes to Condensed Consolidated Financial Statements (unaudited)

7

ITEM 2:

Management’s Discussion and Analysis of Financial Condition and Results of Operations

26

ITEM 3:

Quantitative and Qualitative Disclosures about Market Risk

36

ITEM 4:

Controls and Procedures

36

PART II

OTHER INFORMATION

38

ITEM 1:

Legal Proceedings

38

ITEM 1A :

Risk Factors

38

ITEM 2:

Unregistered Sales of Equity Securities and Use of Proceeds

39

ITEM 3:

Default upon Senior Securities

39

ITEM 4:

Mine Safety Disclosures

39

ITEM 5:

Other Information

39

ITEM 6:

Exhibits

40

SIGNATURES

41

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PART I – FINANCIAL INFORMATION

ITEM 1 – FINANCIAL STATEMENTS

NeuroBo Pharmaceuticals, Inc.

Condensed Consolidated Balance Sheets

(in thousands, except share amounts and par value)

    

June 30, 

    

December 31, 

 

2020

2019

 

(unaudited)

 

Assets

Current assets:

Cash

$

14,298

$

13,908

Restricted cash

15

Prepaid expenses

908

153

Other assets

 

37

 

42

Total current assets

 

15,243

 

14,118

Right-of-use assets

105

116

Property and equipment, net

 

172

 

200

Other assets

 

32

 

34

Total assets

$

15,552

$

14,468

Liabilities and stockholders’ equity

Current liabilities:

Accounts payable

$

1,683

$

638

Accrued liabilities

 

1,426

 

1,422

Lease liability, short-term

23

22

Total current liabilities

 

3,132

 

2,082

Lease and other long-term liabilities

82

94

Total liabilities

 

3,214

 

2,176

Commitments and contingencies (Note 5)

Stockholders’ equity:

Preferred stock, $0.001 par value; 10,000,000 shares authorized; no shares issued or outstanding as of June 30, 2020 and December 31, 2019.

Common stock, $0.001 par value per share, 100,000,000 shares authorized; 16,427,307 and 15,592,718 shares issued and outstanding as of June 30, 2020 and December 31, 2019, respectively.

 

17

 

16

Additional paid–in capital

 

56,317

 

49,130

Accumulated other comprehensive (loss) income

(16)

12

Accumulated deficit

 

(43,980)

 

(36,866)

Total stockholders’ equity

 

12,338

 

12,292

Total liabilities and stockholders’ equity

$

15,552

$

14,468

See accompanying notes to condensed consolidated financial statements.

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NeuroBo Pharmaceuticals, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(in thousands, except share and per share amounts)

(unaudited)

For the Three Months Ended

For the Six Months Ended

June 30, 

June 30, 

2020

2019

2020

2019

Operating expenses:

    

    

    

    

    

Research and development

$

674

$

948

$

2,826

$

2,748

General and administrative

 

1,718

 

939

 

4,315

 

1,590

Total operating expenses

 

2,392

 

1,887

 

7,141

 

4,338

Loss from operations

 

(2,392)

 

(1,887)

 

(7,141)

 

(4,338)

Interest income (expense), net

 

8

 

(14)

 

28

 

(27)

Other expense, net

 

 

 

(1)

 

Loss before income taxes

(2,384)

(1,901)

(7,114)

(4,365)

Provision for income taxes

 

Net loss

 

(2,384)

 

(1,901)

 

(7,114)

 

(4,365)

Other comprehensive loss:

Foreign currency translation loss, net of tax

6

11

(28)

9

Total other comprehensive loss

6

11

(28)

9

Comprehensive loss

$

(2,378)

$

(1,890)

$

(7,142)

$

(4,356)

Loss per share:

Net loss per share, basic and diluted (Note 11)

$

(0.15)

$

(0.37)

$

(0.44)

$

(0.84)

Weighted average common shares outstanding:

Basic and diluted

 

16,303,681

 

5,166,812

 

15,987,240

 

5,166,812

See accompanying notes to condensed consolidated financial statements.

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NeuroBo Pharmaceuticals, Inc.

Condensed Consolidated Statements of Changes in Stockholders’ Equity (Deficit)

(in thousands, except share amounts)

(unaudited)

Redeemable Convertible

Additional

Accumulated

Preferred Stock

Common Stock

Paid–In

Other Comprehensive

Accumulated

Total

 

    

Shares

    

Amount

  

  

Shares

    

Amount

    

Capital

(Loss) Income

    

Deficit

    

Equity (Deficit)

 

Balance at January 1, 2020

$

15,592,718

$

16

$

49,130

$

12

$

(36,866)

$

12,292

Exercise of stock options

84,589

53

53

Stock–based compensation 

159

159

Foreign currency translation adjustment

(34)

(34)

Net loss

(4,730)

(4,730)

Balance at March 31, 2020

15,677,307

16

49,342

(22)

(41,596)

7,740

Issuance of common stock in connection with equity financing

750,000

1

7,499

7,500

Transaction costs in connection with equity financing

(984)

(984)

Stock–based compensation 

171

171

Issuance of broker warrants in connection with equity financing

289

289

Foreign currency translation adjustment

6

6

Net loss

(2,384)

(2,384)

Balance at June 30, 2020

$

16,427,307

$

17

$

56,317

$

(16)

$

(43,980)

$

12,338

Balance at January 1, 2019

 

4,801,020

$

16,746

5,166,812

$

$

2,266

$

2

$

(15,554)

$

(13,286)

Stock-based compensation

60

60

Foreign currency translation adjustment

(2)

(2)

Net loss

(2,464)

(2,464)

Balance at March 31, 2019

4,801,020

16,746

5,166,812

2,326

(18,018)

(15,692)

Issuance of redeemable convertible preferred stock, net of issuance costs of $65

3,463,593

24,175

Stock-based compensation

79

79

Foreign currency translation adjustment

11

11

Net loss

(1,901)

(1,901)

Balance at June 30, 2019

8,264,613

$

40,921

5,166,812

$

$

2,405

$

11

$

(19,919)

$

(17,503)

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See accompanying notes to condensed consolidated financial statements.

NeuroBo Pharmaceuticals, Inc.

Condensed Consolidated Statements of Cash Flows

(in thousands)

(unaudited)

For the Six Months Ended

 

June 30, 

 

2020

2019

 

Operating activities

Net loss

$

(7,114)

$

(4,365)

Adjustments to reconcile net loss to net cash used in operating activities:

Stock-based compensation

 

330

 

139

Non cash interest related to convertible notes - related party

 

 

29

Depreciation

 

23

 

1

Lease liability principal payment

(10)

Non-cash lease expense

10

Change in assets and liabilities, net of the effects of the reverse asset acquisition:

Prepaid expenses and other assets

 

(751)

 

899

Accounts payable

 

1,045

 

599

Accrued and other liabilities

 

5

 

282

Net cash used in operating activities

 

(6,462)

 

(2,416)

Investing activities

Purchases of property and equipment

(2)

(25)

Net cash used in investing activities

 

(2)

 

(25)

Financing activities

Proceeds from issuance of common stock and redeemable convertible preferred stock

7,500

24,240

Exercise of stock options

53

Issuance costs

(695)

(65)

Net cash provided by financing activities

 

6,858

 

24,175

Net increase in cash and restricted cash

 

394

 

21,734

Net foreign exchange difference

(19)

9

Cash and restricted cash at beginning of period

 

13,923

 

2,845

Cash and restricted cash at end of period

$

14,298

$

24,588

Supplemental disclosure of cash flow information:

Cash paid for income taxes

$

$

Cash paid for interest

$

$

Supplemental non-cash investing and financing transactions:

Placement warrants issued in connection with equity financing

$

289

$

See accompanying notes to condensed consolidated financial statements.

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NeuroBo Pharmaceuticals, Inc.

Notes to Condensed Consolidated Financial Statements

1. The Company and Basis of Presentation

NeuroBo Pharmaceuticals, Inc. (together with its subsidiaries, the "Company" or "NeuroBo"), formerly known as Gemphire Therapeutics Inc. (“Gemphire”), is a clinical-stage biotechnology company with three therapeutics programs designed to impact a range of indications in neurodegenerative and cardiometabolic disease:

NB-01, which is primarily focused on the development of a treatment for painful diabetic neuropathy, but which the Company believes could also treat a range of neuropathic conditions, including chemotherapy-induced peripheral neuropathy and post-traumatic peripheral neuropathy;
NB-02, which has the potential to treat the symptoms of cognitive impairment and modify the progression of neurodegenerative diseases associated with the malfunction of a protein called tau, and with amyloid beta plaque deposition; and
Gemcabene, which is focused on developing and commercializing therapies for the treatment of dyslipidemia, a serious medical condition that increases the risk of life-threatening cardiovascular disease, focused on orphan indications such as homozygous familial hypercholesterolemia, as well as nonalcoholic fatty liver disease/nonalcoholic steatohepatitis.

The Company was originally incorporated as Gemphire Therapeutics Inc. In connection with the closing of the Merger (as defined below), the Company changed its name to NeuroBo Pharmaceuticals, Inc. The Company’s operations have consisted principally of performing research and development activities, clinical development and raising capital. The Company's activities are subject to significant risks and uncertainties, including failing to secure additional funding before sustainable revenues and profit from operations are achieved.

COVID-19

The Company is subject to risks and uncertainties as a result of the COVID-19 pandemic. The extent of the impact of the COVID-19 pandemic on the Company’s business is highly uncertain and difficult to predict, as the responses that the Company, other businesses and governments are taking continue to evolve. Furthermore, capital markets and economies worldwide have also been negatively impacted by the COVID-19 pandemic, and it is possible that it could cause a lasting national and/or global economic recession. Policymakers around the globe have responded with fiscal policy actions to support the healthcare industry and economy as a whole. The magnitude and overall effectiveness of these actions remain uncertain.

To date, except for the adjustments to scientific activity described under “Current Scientific Activity” below, the Company has not experienced any significant changes in our business that would have a significant negative impact on our consolidated statements of operations or cash flows.

The severity of the impact of the COVID-19 pandemic on the Company’s business will depend on a number of factors, including, but not limited to, the duration and severity of the pandemic and the extent and severity of the impact on the Company’s service providers, suppliers, contract research organizations and the Company’s clinical trials, all of which are uncertain and cannot be predicted. As of the date of issuance of Company’s financial statements, the extent to which the COVID-19 pandemic may in the future materially impact the Company’s financial condition, liquidity or results of operations is uncertain.

Current Scientific Activity

In light of the present business environment, including the impact of the COVID-19 virus that emerged in December

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NeuroBo Pharmaceuticals, Inc.

Notes to Condensed Consolidated Financial Statements

2019 and became a global pandemic, the Company is currently conducting the scientific activities described below with a view toward conserving financial resources.

For NB-01, the Company has determined that any attempt to conduct Phase 3 clinical trials, as previously announced, would be difficult if not impossible in the short or medium term. Accordingly, in the first quarter of 2020, the Company directed its contract research organization (“CRO”) partners and other vendors working on the Phase 3 clinical trials of NB-01 to cease all work and has terminated its existing contract arrangements with each of them.

The Company is currently devoting scientific resources to evaluating the potential to bring the NB-01 asset to the market through a different regulatory pathway. Development of NB-01 as an orphan drug is among the alternatives that the Company is considering, and the Company may conduct feasibility studies to identify a rare disease relevant to NB-01. There is no assurance that the Company will be able to pursue any orphan drug indication for NB-01.The Company considered marketing NB-01 as a nutraceutical (non-pharmaceutical) product, but has determined not to pursue such pathway at this time.

The Company is preparing an Investigational New Drug (“IND”) application to the U.S. Food and Drug Administration (“FDA”) for NB-02. The Company intends to postpone the first human clinical trials for NB-02 until global health and macroeconomic conditions improve, with a view toward commencing clinical trial activity in the first half of 2021, subject to improvement of the constraints imposed by the COVID-19 pandemic. The Company is also considering engaging with a strategic partner to assist with clinical trials for NB-02.

In May 2020, the Company received written communication from the U.S. Food and Drug Administration (“FDA”) that the clinical development program for Gemcabene remains on a partial clinical hold. The Company is reviewing its options regarding Gemcabene.

Merger

On July 24, 2019, Gemphire Therapeutics Inc. (“Gemphire”), and NeuroBo Pharmaceuticals, Inc. (“Private NeuroBo”) entered into a definitive agreement, which was amended on October 29, 2019 (the “Merger Agreement”). The merger closed on December 30, 2019 (the “Effective Date”), whereby Private NeuroBo merged with a wholly-owned subsidiary of the Company in an all-stock transaction (the “Merger”).

Upon completion of the Merger, the Company changed its name to NeuroBo Pharmaceuticals, Inc., Private NeuroBo changed its name to NeuroBo Therapeutics, Inc., and the Company changed its ticker symbol on the Nasdaq Capital Market from “GEMP” to "NRBO". Except as otherwise indicated, references herein to “NeuroBo,” “the Company,” the “combined company,” “we,” “us,” and “our,” refer to NeuroBo Pharmaceuticals, Inc. on a post-Merger basis.

Pursuant to the terms of the Merger Agreement, each outstanding share of Private NeuroBo common stock outstanding immediately prior to the closing of the Merger was converted into 1.1431 shares of the Company’s common stock (the “Exchange Ratio”). Immediately prior to the closing of the Merger, all shares of Private NeuroBo redeemable preferred stock then outstanding were exchanged into shares of common stock of Private NeuroBo. In addition, all outstanding options exercisable for common stock of Private NeuroBo converted into options exercisable for shares of the Company’s common stock upon the Merger. Such options and their related terms were adjusted by the Exchange Ratio. Immediately following the Merger, the stockholders of Private NeuroBo owned approximately 96.2% of the outstanding common stock of the Company.

The transaction was accounted for as a reverse asset acquisition in accordance with accounting principles generally accepted in the United States of America (“GAAP”). Under this method of accounting, Private NeuroBo was deemed to be the accounting acquirer for financial reporting purposes. This determination was primarily based on the facts that, immediately following the Merger: (i) Private NeuroBo’s stockholders owned substantially all of the voting rights in the

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NeuroBo Pharmaceuticals, Inc.

Notes to Condensed Consolidated Financial Statements

combined company, (ii) Private NeuroBo designated all, but one, of the members of the initial board of directors of the combined company, and (iii) Private NeuroBo’s senior management holds all key positions in the senior management of the combined company. As a result, as of the closing date of the Merger, the net assets of Gemphire were recorded at their acquisition-date relative fair values in the consolidated financial statements of the Company and the reported operating results prior to the Merger are those of Private NeuroBo.

Basis of presentation and consolidation principles

 

The accompanying condensed consolidated financial statements have been prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”). Certain information and footnote disclosures normally included in annual financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. The condensed consolidated financial statements may not include all disclosures required by GAAP; however, the Company believes that the disclosures are adequate to make the information presented not misleading. These unaudited condensed financial statements should be read in conjunction with the audited financial statements and the notes thereto for the fiscal year ended December 31, 2019 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 30, 2020. The condensed consolidated balance sheet at December 31, 2019 was derived from the audited financial statements.

In the opinion of management, all adjustments, consisting of only normal recurring adjustments that are necessary to present fairly the financial position, results of operations, and cash flows for the interim periods, have been made. The results of operations for the interim periods are not necessarily indicative of the operating results for the full fiscal year or any future periods.

On August 11, 2019, Private NeuroBo’s board of directors and stockholders approved an amendment to the restated certificate of incorporation to affect a ten thousand-for-one (10,000-for-1) stock split of Private NeuroBo's common stock and convertible preferred stock. The par value and the authorized shares of the common and convertible preferred stock and the exercise prices of options to purchase common stock were adjusted accordingly as a result of the stock split. All issued and outstanding common stock, options for common stock, convertible preferred stock and convertible notes, as well as the exercise price of each option for common stock and the conversion price for convertible preferred stock and convertible notes, have been retroactively adjusted to reflect this stock split for all periods presented.

All of the share and per share amounts presented were adjusted, on a retroactive basis, to reflect the ten thousand-for-one (10,000-for-1) stock split and the effect of the exchange of the shares of Private NeuroBo into the shares of the Company at the Exchange Ratio, except for par value and share authorizations of Private NeuroBo for periods presented prior to the Merger.

The condensed consolidated financial statements of the Company include a South Korean subsidiary, NeuroBo Co., LTD., which is fully owned by the Company. All significant intercompany accounts and transactions have been eliminated in the preparation of the financial statements.

Reclassification of Prior Year Amounts

Interest income reported during the comparable prior year periods was reclassified from the other (expense) income, net line item to the interest income (expense), net line item to conform to current year classifications.

Going Concern

 

From its inception through June 30, 2020, the Company has devoted substantially all of its efforts to drug discovery and development and conducting clinical trials. The Company has a limited operating history and the sales and income potential of the Company's business and market are unproven. Successful transition to attaining profitable operations is

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NeuroBo Pharmaceuticals, Inc.

Notes to Condensed Consolidated Financial Statements

dependent upon achieving a level of revenues adequate to support the Company's cost structure. As of June 30, 2020, the Company had $14.3 million in cash. The Company has experienced net losses and negative cash flows from operating activities since its inception and had an accumulated deficit of $44.0 million as of June 30, 2020.

To date, the Company has raised capital principally through the issuance of common stock, convertible notes and private placements of redeemable convertible preferred stock. The Company has raised a total of $16.8 million from the issuance by Private NeuroBo of Series A redeemable convertible preferred stock and $0.5 million from the issuance by Private NeuroBo of convertible notes through December 31, 2018, and $24.2 million from the issuance by Private NeuroBo of Series B redeemable convertible preferred stock in May and June 2019. On April 13, 2020, the Company entered into a Securities Purchase Agreement, pursuant to which the Company agreed to issue and sell, in a registered direct offering (the “Registered Offering”), 750,000 shares of common stock at an offering price of $10 per share. The Registered Offering resulted in gross proceeds of $7.5 million. The Company will need to continue to raise a substantial amount of funds until it is able to generate revenues to fund its development activities.

The determination as to whether the Company can continue as a going concern contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Company expects to continue to incur net losses and negative cash flows from operations into the foreseeable future. Successful transition to attaining profitable operations is dependent upon achieving a level of revenues adequate to support the Company's cost structure. The Company has incurred net losses since inception and has relied on its ability to fund its operations through debt and equity financings. These conditions raise substantial doubt about the Company's ability to continue as a going concern. The accompanying condensed consolidated financial statements have been prepared assuming that the Company will continue as a going concern and do not include any adjustments that might result from the outcome of this uncertainty. This basis of accounting contemplates the recovery of the Company's assets and the satisfaction of liabilities in the normal course of business.

The Company believes that its existing cash will be sufficient to fund its operations into the second quarter of 2021 at the level of scientific activity described above under “Current Scientific Activity. The Company plans to continue to fund its operations and capital funding needs through a combination of equity offerings, debt financings, or other sources, potentially including collaborations, licenses and other similar arrangements. There can be no assurance that the Company will be able to obtain any sources of financing on acceptable terms, or at all. To the extent that the Company can raise additional funds by issuing equity securities, the Company's stockholders may experience significant dilution. Any debt financing, if available, may involve restrictive covenants that impact the Company's ability to conduct its business.

2. Summary of Significant Accounting Policies 

Use of estimates

 

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, expenses, and related disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of expenses during the reporting period. The most significant estimates in Company's consolidated financial statements relate to accrued expenses and the fair value of stock-based compensation and warrant issuances. The Company bases its estimates on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgements about the carrying values of assets and liabilities. Actual results could differ from those estimates. Changes in estimates are reflected in reported results in the period in which they become known.

Concentration of Credit Risk

 

Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash. The

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NeuroBo Pharmaceuticals, Inc.

Notes to Condensed Consolidated Financial Statements

Company’s cash is principally held by one financial institution in the United States. Amounts on deposit may at times exceed federally insured limits. Management believes that the financial institution is financially sound, and accordingly, minimal credit risk exists with respect to the financial institution. As of June 30, 2020, the Company had deposits in excess of federally insured amounts by $13.7 million.

Fair Value of Financial Instruments

The Company’s financial instruments include principally cash, prepaid, other current assets, right of use assets, accounts payable, accrued liabilities, lease liabilities, convertible debt and preferred stock. The carrying amounts of prepaid expenses, accounts payable, and accrued liabilities are reasonable estimates of their fair value because of the short maturity of these items.

General and Administrative Expenses

General and administrative expenses consist primarily of personnel-related costs, including salaries and stock-based compensation costs, for personnel in functions not directly associated with research and development activities. Other significant costs include legal fees related to intellectual property and corporate matters and professional fees for accounting and other services.

Research and Development Costs

Research and development costs are charged to expense as incurred. Research and development expenses are comprised of costs incurred in performing research and development activities, including clinical trial costs, manufacturing costs for both clinical and pre-clinical materials as well as other contracted services, license fees, and other external costs. Nonrefundable advance payments for goods and services that will be used in future research and development activities are expensed when the activity is performed or when the goods have been received, rather than when payment is made, in accordance with Accounting Standards Codification (“ASC”) 730, Research and Development.

Income Taxes

The Company utilizes the liability method of accounting for income taxes as required by ASC 740, Income Taxes. Under this method, deferred tax assets and liabilities are determined based on differences between financial reporting and the tax basis of assets and liabilities and are measured using enacted tax rates and laws that will be in effect when the differences are expected to reverse. Currently, there is no provision for income taxes, as the Company has incurred operating losses to date, and a full valuation allowance has been provided on the net deferred tax assets.

Stock-Based Compensation

The Company accounts for stock-based compensation in accordance with the provisions of ASC 718, Compensation — Stock Compensation (“ASC 718”). Accordingly, compensation costs related to equity instruments granted are recognized at the grant-date fair value. The Company records forfeitures when they occur. Stock-based compensation arrangements to non-employees are accounted for in accordance with the applicable provisions of ASC 718 using a fair value approach.

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NeuroBo Pharmaceuticals, Inc.

Notes to Condensed Consolidated Financial Statements

Convertible Notes

 

The Company evaluates all conversion and redemption features contained in a debt instrument to determine if there are any embedded features that require bifurcation as a derivative or separation as a beneficial conversion feature. The host debt instrument is discounted for the value of any embedded feature that is accounted for as either a derivative or a beneficial conversion feature. The discount is amortized and recorded to interest expense over the term of the host debt instrument using the effective interest method. The Company’s convertible debt contained an embedded beneficial conversion feature that was separated and recorded as additional paid-in capital.

Fair Value of common stock

In the absence of a public trading market prior to the Merger, and as a development stage company with no significant revenues, the Company believed that it was appropriate to consider a range of factors to determine the fair value of the common stock at each grant date. In determining the fair value of its common stock, the Company used methodologies, approaches, and assumptions consistent with the American Institute of Certified Public Accountants' (“AICPA”) Audit and Accounting Practice Aid Series: Valuation of Privately Held Company Equity Securities Issued as Compensation (the "AICPA Practice Guide"). The valuations of Private NeuroBo common stock were prepared using a hybrid method, which used market approaches to estimate the enterprise value of Private NeuroBo. The hybrid method is a probability-weighted expected return method ("PWERM"), where the equity value in one or more of the scenarios is calculated using an option pricing method ("OPM"). The PWERM is a scenario-based methodology that estimates the fair value of common stock based upon an analysis of future values for Private NeuroBo, assuming various outcomes. The common stock value was based on the probability-weighted present value of expected future investment returns considering each of the possible outcomes available as well as the rights of each class of stock. The future value of the common stock under each outcome was discounted back to the valuation date at an appropriate risk-adjusted discount rate and probability weighted to arrive at an indication of value for the common stock. A discount for lack of marketability of the common stock was then applied to arrive at an indication of value for the common stock. The OPM treats common stock and preferred stock as call options on the total equity value of a company, with exercise prices based on the value thresholds at which the allocation among the various holders of a company's securities changes. Under this method, the common stock has value only if the funds available for distribution to stockholders exceeded the value of the preferred stock liquidation preferences at the time of the liquidity event, such as a strategic sale or a merger. In addition, the Company considered various objective and subjective factors, along with input from an independent third-party valuation firm. The factors included (1) the achievement of technical and operational milestones by the Company; (2) the status of strategic relationships with collaborators; (3) the significant risks associated with the Company's stage of development; (4) capital market conditions for life science companies and, in particular, similarly situated, privately held, early-stage life science companies; (5) the Company's available cash, financial condition, and results of operations; (6) the most recent sales of the Company's preferred stock to the extent they were with outside parties; and (7) the preferential rights of the outstanding preferred stock.

Leases

On July 1, 2019, the Company adopted Accounting Standards Update (“ASU”) No. 2016-02, Leases (Topic 842) (“ASU 2016-02”). The Company assesses its contracts at inception to determine whether the contract contains a lease, including evaluation of whether the contract conveys the right to control an explicitly or implicitly identified asset for a period of time. The Company has recognized right-of-use assets and lease liabilities that represent the net present value of future operating lease payments utilizing a discount rate corresponding to the Company’s incremental borrowing rate and amortized over the remaining terms of the leases. For operating leases of a short-term nature, i.e., those with a term of less than twelve months, the Company recognizes lease payments as an expense on a straight-line basis over the remaining lease term. 

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Notes to Condensed Consolidated Financial Statements

Property and Equipment

 

Property and equipment is recorded at cost and reduced by accumulated depreciation. Depreciation expense is recognized over the estimated useful lives of the assets using the straight-line method. The estimated useful life for property and equipment ranges from three to five years. Tangible assets acquired for research and development activities and that have an alternative use are capitalized over the useful life of the acquired asset. Estimated useful lives are periodically reviewed, and when appropriate, changes are made prospectively. When certain events or changes in operating conditions occur, asset lives may be adjusted and an impairment assessment may be performed on the recoverability of the carrying amounts. Maintenance and repairs are charged directly to expense as incurred.

Foreign Currency Translation

The foreign subsidiary uses the local currency as the functional currency. The Company translates the assets and liabilities of its foreign operation into U.S. dollars based on the rates of exchange in effect as of the balance sheet date. Expenses are translated into U.S. dollars using average exchange rates for each period. The resulting adjustments from the translation process are included in accumulated other comprehensive loss in the accompanying condensed consolidated balance sheets.

Certain transactions of the Company are settled in foreign currency and are thus translated to U.S. dollars at the rate of exchange in effect at the end of each month. Gains and losses resulting from the translation are included in other income or expense in the accompanying condensed consolidated statements of operations and comprehensive loss.

Patent Costs

Costs related to filing and pursuing patent applications are expensed as incurred, as recoverability of such expenditures is uncertain. These costs are included in general and administrative expenses.

Comprehensive Loss

Comprehensive loss is comprised of net loss and other comprehensive income or loss. Comprehensive loss includes net loss as well as other changes in stockholders' equity (deficit) that result from transactions and economic events other than those with stockholders. Comprehensive loss currently consists of net loss and changes in foreign currency translation adjustments.

Segment Information

Operating segments are components of an enterprise for which separate financial information is available and is evaluated regularly by the Company’s chief operating decision maker in deciding how to allocate resources and assessing performance. The Company’s chief operating decision maker is its Chief Executive Officer. The Company’s Chief Executive Officer views the Company’s operations and manages its business in one operating segment, which is principally the business of development and commercialization of therapeutics.

Recent Accounting Pronouncements Adopted

 

From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board ("FASB") or other standard setting bodies that are adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on its consolidated financial position or results of operations upon adoption.

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Notes to Condensed Consolidated Financial Statements

In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement (ASU 2018-13). The new guidance modifies the disclosure requirements in Topic 820 as follows:

Removals: the amount of and reasons for transfers between Level 1 and Level 2 of the fair value hierarchy; the policy for timing of transfers between levels; and the valuation processes for Level 3 fair value measurements.
Modifications: for investments in certain entities that calculate net asset value, an entity is required to disclose the timing of liquidation of an investee’s assets and the date when restrictions from redemption might lapse only if the investee has communicated the timing to the entity or announced the timing publicly; and the amendments clarify that the measurement uncertainty disclosure is to communicate information about the uncertainty in measurement as of the reporting date.
Additions: the changes in unrealized gains and losses for the period included in other comprehensive income for recurring Level 3 fair value measurements held at the end of the reporting period; and the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements.

This guidance is effective for all entities for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019. The amendments on changes in unrealized gains and losses, the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements, and the narrative description of measurement uncertainty should all be applied prospectively for only the most recent interim or annual period presented in the initial year of adoption. All other amendments should be applied retrospectively to all periods presented upon their effective date. Early adoption is permitted. The Company adopted the new guidance on January 1, 2020. The guidance did not have a material impact on the consolidated financial statements.

Recent Accounting Pronouncements Not Yet Adopted

In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740) which amends the existing guidance relating to the accounting for income taxes. This ASU is intended to simplify the accounting for income taxes by removing certain exceptions to the general principles of accounting for income taxes and to improve the consistent application of GAAP for other areas of accounting for income taxes by clarifying and amending existing guidance. The ASU is effective for fiscal years beginning after December 15, 2020. The Company does not expect that the adoption of this new guidance will have a material impact on the Company’s consolidated financial statements.

3. Balance Sheet Detail (in thousands)

Property and Equipment

Property and equipment consist of the following:

As of

June 30,

December 31,

2020

2019

Research and development equipment

$

153

$

158

Office equipment

59

59

Total property and equipment

212

217

Less accumulated depreciation

(40)

(17)

Property and equipment, net

$

172

$

200

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Notes to Condensed Consolidated Financial Statements

Depreciation expense was $12 and less than $1 for the three months ended June 30, 2020 and 2019, respectively, and $23 and less than $1 for the six months ended June 30, 2020 and 2019, respectively.

Accrued liabilities

Accrued liabilities consist of the following as of:

    

June 30,

December 31,

 

2020

2019

 

External research and development expenses

$

1,197

$

915

Professional services

167

158

Payroll related

 

27

 

160

Other

 

35

 

189

Total

$

1,426

$

1,422

In the first quarter of 2020, the Company directed its contract research organization (“CRO”) partners and other vendors working on the Phase 3 clinical trials of NB-01 to cease all work and has terminated its existing contract arrangements with each of them. The Company incurred termination expenses of approximately $675 in connection with these terminations which are included in the external research and development expenses line item in the above table.  One CRO invoiced termination charges that the Company disputes. In accordance with ASC 450, Contingencies, the Company has determined that it is reasonably possible that a loss has occurred with respect to these invoiced amounts and estimates the range of loss as $0 to $1,100. Since no amount in this range is a better estimate than any other amount within the range, the Company has not accrued any liability arising from potential losses relating to these disputed termination charges.

During the three months ended March 31, 2020, the Company recorded adjustments to research and development expenses related to clinical trial expenses that were not correctly recorded in prior periods. The net adjustments resulted in an increase of $186 in the Company’s net loss for the three months ended March 31, 2020, which the Company considers immaterial to all periods.

4. Merger

The Merger, which closed on December 30, 2019, was accounted for as a reverse asset acquisition pursuant to Topic 805, Business Combinations, as substantially all of the fair value of the assets acquired were concentrated in a group of similar non-financial assets, and the acquired assets did not have outputs or employees.

Contingent Value Rights Agreement

On December 30, 2019, in connection with the Merger, the Company, Grand Rapids Holders’ Representative, LLC, as representative of the Company’s stockholders prior to the Merger, and Computershare Inc. and Computershare Trust Company, N.A. as the rights agent, entered into a Contingent Value Rights Agreement (the “CVR Agreement”). The Company’s stockholders of record as of immediately prior to the effective date of the Merger received one contingent value right (“CVR”) entitling such holders to receive, in the aggregate, 80% of the Gross Consideration less other Permitted Deductions (each as defined in the CVR Agreement) received during the 15-year period after the closing of the Merger (the “CVR Term”) from the grant, sale or transfer of rights to Gemcabene (other than a grant, sale or transfer of rights involving a sale or disposition of the post-Merger combined company) that is entered into during the 10-year period after the closing of the Merger or pursuant to the Beijing SL Agreement (as defined in Note 6 – License Agreement below), but not including the $2.5 million upfront gross payment pursuant to the Beijing SL Agreement. Under the CVR Agreement, the Company agreed to commit up to $1 million to support the further development of

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Notes to Condensed Consolidated Financial Statements

Gemcabene, to be funded following execution of the Beijing SL Agreement and the receipt by the Company of the $2.5 million upfront gross payment payable under the Beijing SL Agreement, which the Company received in October 2019. The CVRs are not transferable, except in certain limited circumstances, will not be certificated or evidenced by any instrument, will not accrue interest and will not be registered with the SEC or listed for trading on any exchange. The CVR Agreement will continue in effect until the later of the end of the CVR Term and the payment of all amounts payable thereunder. Through June 30, 2020, no milestones had been accrued as there were no potential milestones yet considered probable.

5. Commitments and Contingencies (in thousands)

Operating Leases

Boston Leases

In April 2018, the Company entered a non-cancelable operating lease for its headquarters in Boston, MA (the “Boston Lease”). The lease was subsequently amended, and the term was extended to August 2019 with an option to extend the term on a month-to-month basis. The Company exercised the option and extended the lease term on a month-to-month basis through January 15, 2020. The lease is subject to base lease payments and additional charges for common costs related to usage of shared space. Due to its short-term nature, the Company recognizes lease payments as an expense on a straight-line basis over the remaining lease term.

In September 2019, the Company entered a non-cancelable operating lease, as amended, for its new corporate headquarters located in Boston, Massachusetts (“New Boston Lease”). The agreement, effective February 1, 2020, has a one-year term, and rental costs of $21 per month prior to the application of certain rent concessions granted by the landlord in the amount of $32.

For the three and six months ended June 30, 2020, expense under the New Boston Lease and Boston Lease in the aggregate was $65 and $180, inclusive of a termination fee of $83, respectively. For the three and six months ended June 30, 2019, expense under the Boston Lease in the aggregate was $27 and $53, respectively.

Future minimum lease payments at June 30, 2020 were as follows under the New Boston Lease (in thousands):

December 31,

2020 (period from July 1 to December 31)

$

129

2021

21

Total minimum payments

$

150

Lease in Korea:

In May 2019, the Company entered a non-cancelable operating lease for its new facility in Korea (the “Korea Lease”). The initial lease term is five years with an option to renew for an additional five-year term. The lease commenced on July 2, 2019 and expires on July 1, 2024. The operating lease is subject to a deposit, base rent payments and additional charges for utilities and other common costs. In the third quarter of 2019, the Company recognized a right-of-use asset of $126 as well as a lease liability of $20 in other current liabilities and $106 in other non-current liabilities in conjunction with the commencement of the Korea Lease. The Company’s lease liability represents the net present value of future lease payments utilizing a discount rate of 10%, which corresponds to the Company’s incremental borrowing rate. As of June 30, 2020, the weighted average remaining lease term was 4.00 years. For the three and six month periods ended June 30, 2020, the Company recorded non-cash expense of $8 and $16, respectively, related to the Korea Lease. During

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Notes to Condensed Consolidated Financial Statements

the six month period ended June 30, 2020, the Company made cash payments of $16 for amounts included in the measurement of lease liabilities. There was no expense or payment activity related to the Korea Lease during the three and six month periods ended June 30, 2019.

The following table reconciles the undiscounted lease liabilities to the total lease liabilities recognized on the consolidated balance sheet as of June 30, 2020 (in thousands):

December 31,

2020 (period from July 1 to December 31)

$

16

2021

32

2022

32

2023

32

2024

16

Total lease payments

128

Less effect of discounting

(23)

Total

105

Short-term portion

(23)

Long-term portion

$

82

Xiehecheng Cultivation Service Agreement

On September 1, 2018, the Company entered into a cultivation service agreement with Xiehecheng Chinese Herm Limited Corporation for the cultivation of two plants used to manufacture the Company's clinical assets.

As of June 30, 2020, future minimum payments under the agreement, which is cancellable annually at the end of each research year, are as follows (in thousands):

December 31,

2020

(period from July 1 to December 31)

$

66

2021

220

2022

220

$

506

Pfizer License Agreement

Upon the close of the Merger, the exclusive license agreement with Pfizer Inc. (“Pfizer”) for the clinical product candidate Gemcabene (the “Pfizer Agreement”) was assumed by the Company. Under the Pfizer Agreement, in exchange for this worldwide exclusive right and license to certain patent rights to make, use, sell, offer for sale and import the clinical product Gemcabene, the Company has agreed to certain milestone and royalty payments on future sales.

The Company agreed to make milestone payments totaling up to $37 million upon the achievement of certain milestones, including the first new drug application (or its foreign equivalent) in any country, regulatory approval in each of the United States, Europe and Japan, the first anniversary of the first regulatory approval in any country, and upon achieving certain aggregate sales levels of Gemcabene. Future milestone payments under the Pfizer Agreement, if any, are not expected to begin for at least several years and extend over a number of subsequent years.

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Notes to Condensed Consolidated Financial Statements

The Company also agreed to pay Pfizer tiered royalties on a country-by-country basis based upon the annual amount of net sales, as specified in the Pfizer Agreement, until the later of: (a) five (5) years after the first commercial sale in such country; (b) the expiration of all regulatory or data exclusivity for Gemcabene in such country; and (c) the expiration or abandonment of the last valid claim of the licensed patents, including any patent term extensions or supplemental protection certificates in such country (collectively, the Royalty Term). Under the Pfizer Agreement, the Company is obligated to use commercially reasonable efforts to develop and commercialize Gemcabene.

None of the future milestone or royalty payments were triggered through June 30, 2020.

The Pfizer Agreement will expire upon expiration of the Royalty Term. On expiration (but not earlier termination), the Company will have a perpetual, exclusive, fully paid-up, royalty-free license under the licensed patent rights and related data to make, use, develop, commercialize, import and otherwise exploit the clinical product candidate Gemcabene. Either party may terminate the Pfizer Agreement for the other party’s material breach following a cure period or immediately upon certain insolvency events relating to the other party. Pfizer may immediately terminate the Pfizer Agreement in the event that (i) the Company or any of its affiliates or sublicenses contests or challenges, or supports or assists any third party to contest or challenge, Pfizer’s ownership of or rights in, or the validity, enforceability or scope of any of the patents licensed under the Pfizer Agreement or (ii) the Company or any of its affiliates or sublicensees fails to achieve the first commercial sale in at least one country by April 16, 2024.

Furthermore, upon termination of the Pfizer Agreement by Pfizer for any of the foregoing reasons, the Company grants Pfizer a non-exclusive, fully paid-up, royalty free, worldwide, transferrable, perpetual and irrevocable license to use any intellectual property rights arising from the development or commercialization of Gemcabene by the Company and any trademarks identifying Gemcabene and agrees to transfer regulatory filings and approvals to Pfizer or permit Pfizer to cross-reference and rely on such regulatory filings and approvals for Gemcabene. The Company may terminate the Pfizer Agreement for convenience upon 90 days’ written notice and payment of an early termination fee of $3.0 million.

As of June 30, 2020 and December 31, 2019, there was sufficient uncertainty with regard to both the outcome of the clinical trials and the ability to obtain sufficient funding to support any of the cash milestone payments under the license agreement, and as such, no liabilities were recorded related to the Pfizer Agreement.

Contingencies

From time to time, the Company may be subject to various claims and suits arising in the ordinary course of business. The Company does not expect that the resolution of these matters will have a material adverse effect on its financial position or results of operations.

Contract Research Agreements

In the first quarter of 2020, the Company directed its CRO partners and other vendors working on the Phase 3 clinical trials of NB-01 to cease all work and has terminated its existing contract arrangements with each of them. The Company incurred termination expenses of approximately $675 in connection with these terminations. One CRO invoiced termination charges that the Company disputes. In accordance with ASC 450, Contingencies, the Company has determined that it is reasonably possible that a loss has occurred with respect these invoiced amounts and estimates the range of loss as $0 to $1,100. Since no amount in this range is a better estimate than any other amount within the range, the Company has not accrued any liability arising from potential losses relating to these disputed termination charges.

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Notes to Condensed Consolidated Financial Statements

6. License Agreement

Beijing SL License and Collaboration Agreement

Upon the close of the Merger, the License and Collaboration Agreement (the “Beijing SL Agreement”) with Beijing SL Pharmaceutical Co., Ltd. (“Beijing SL”) was assumed by the Company, pursuant to which the Company granted Beijing SL an exclusive royalty-bearing license to research, develop, manufacture and commercialize pharmaceutical products comprising, as an active ingredient, Gemcabene in mainland China, Hong Kong, Macau and Taiwan (each, a “region,” and collectively, the “Territory”). The terms of the agreement include payments based upon achievement of milestones and royalties on net product sales. Under the Beijing SL Agreement, the Company has variable consideration in the form of milestone payments. As of June 30, 2020, no revenue under the Beijing SL Agreement has been recognized.

Under the terms of the Beijing SL Agreement, Beijing SL will be responsible, at its expense, for developing and commercializing products containing Gemcabene (each, a “Licensed Product”) in the Territory, with certain assistance from the Company. To the extent mutually agreed to in writing, the Company and Beijing SL will collaborate on the Phase 3 clinical trial for homozygous familial hypercholesterolemia or other clinical trials with the Company as the sponsor designed to enroll patients both inside and outside the Territory (a “Global Study”), but Beijing SL will be responsible, at its expense, for the conduct of any Global Study to the extent solely in the Territory, subject to the Company’s final decision making authority, and the Company will be responsible, at its expense, for the conduct of any Global Study to the extent solely outside of the Territory. Under a territory development plan, the parties shall develop Licensed Products with respect to the Territory. Beijing SL will be responsible for development activities, including non-clinical and clinical studies directed at obtaining regulatory approval of the Licensed Product in the Territory. Beijing SL has agreed to use commercially reasonable efforts to commercialize the Licensed Products for each indication that receives regulatory approval in the Territory and shall prepare and present a commercialization plan that shall be subject to approval by the joint steering committee.

Pursuant to the Beijing SL Agreement, Beijing SL was to make a non-refundable upfront gross payment of $2.5 million to the Company within 45 days of the effective date of the Beijing SL Agreement; the upfront payment was received in October 2019 and such funds were fully expended prior to the close of Merger. Additionally, with respect to each Licensed Product, the Company is eligible to receive (i) payments for specified developmental and regulatory milestones (including submission of a new drug application to China’s National Medical Product Administration, dosing of the first patient in a phase 3 clinical trial in mainland China and regulatory approval for the first and each additional indication of a Licensed Product in the Territory) totaling up to $6 million in the aggregate and (ii) payments for specified global net sales milestones of up to $20 million in the aggregate multiplied by the ratio of the net sales of a Licensed Product sold by Beijing SL in the Territory divided by the global net sales of a Licensed Product, which net sales milestone payments are payable once, upon the first achievement of such milestone.

 

Beijing SL is also obligated to pay the Company tiered royalties ranging from the mid-teens to twenty percent on the net sales of all Licensed Products in the Territory until the latest of (a) the date on which any applicable regulatory exclusivity with respect to such Licensed Product expires in such region, (b) the expiration or abandonment of the last valid patent claim or joint patent claim covering such Licensed Product in each region and (c) the fifth anniversary of the first commercial sale of such Licensed Product in such region (the “Royalty Term”). Future milestone payments under the Beijing SL Agreement, if any, are not expected to begin for at least one year and will extend over a number of subsequent years. The Company cannot determine the date on which Beijing SL’s potential royalty payment obligations to the Company would expire because Beijing SL has not yet developed any Licensed Products under the Beijing SL Agreement and therefore the Company cannot at this time identify the date of the first commercial sale or the periods of any regulatory exclusivity or patent claims with respect to any Licensed Product.

On a Licensed Product-by-Licensed Product and region-by-region basis upon the expiration of the Royalty Term, the license granted to Beijing SL shall be deemed perpetual, fully paid-up and royalty free with respect to such Licensed

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Notes to Condensed Consolidated Financial Statements

Product in such region. Either party may terminate the Agreement (x) with written notice in the event of the other party’s material breach following a cure period or (y) if the other party becomes subject to certain insolvency proceedings. In addition, the Company may terminate the agreement in its entirety if Beijing SL or its affiliates or sublicensees commence a proceeding challenging the validity, enforceability or scope of any of the Company’s patents.

To the extent rights granted to Beijing SL under the Beijing SL Agreement are controlled by the Company pursuant to the Pfizer Agreement, such rights are subject to the terms and conditions of such agreement with Pfizer, and Beijing SL has agreed to comply with such terms and conditions.

The Beijing SL Agreement contemplates that Beijing SL and the Company shall, no later than twelve months prior to the anticipated date of the first commercial sale of a Licensed Product, if any, negotiate in good faith and execute a commercial supply agreement, pursuant to which Beijing SL shall purchase from the Company, and the Company shall use commercially reasonable efforts to supply, Gemcabene or Licensed Product for clinical or commercial purposes, as applicable, until manufacturing and regulatory transfers are complete.

Each of the Company and Beijing SL has agreed to indemnify the other party against certain losses and expenses relating to the development or commercialization of a Licensed Product by the indemnifying party, the negligence or willful misconduct of the indemnifying party or its directors, officers, employees or agents or a breach of the indemnifying party’s representations, warranties or covenants.

7. Debt (in thousands, except share and per share data)

In February 2018, the Company received a total of $500 from the issuance by Private NeuroBo of convertible promissory notes (the "Convertible Notes") with an original maturity date of December 31, 2022. On December 30, 2019, the Convertible Notes were converted into 1,565,300 shares of common stock.

Prior to conversion, the lenders had the option to convert all of the then-unpaid note balance including principal and accrued but unpaid interest into common stock, at a conversion price of $0.40 per share after the earlier of (A) the closing of a firmly underwritten public offering pursuant to an effective registration statement under the Securities Act of 1933, as amended, covering the offer and sale of common stock for the account of the Company in the United States of America or similar registration in the Republic of Korea, or (B) January 1, 2020. On October 23, 2019, the Convertible Notes were amended (the “Amended Convertible Notes”) to require mandatory conversion upon the completion of a reverse merger transaction based on the then-unpaid note balance including principal and accrued but unpaid interest into common stock, at a conversion price of $0.40 per share.

The Convertible Notes and Amended Convertible Notes (herein collectively referred to as the “Notes”) accrued interest at a rate of 5.00% per annum. The Company recorded interest on principal of $7 and $13 for the three and six month periods ended June 30, 2019, respectively. The Notes were not outstanding during 2020.

The fair value of the common stock, as determined using an option pricing model consistent with the AICPA Practice Guide, was in excess of the conversion price of the Convertible Notes. Accordingly, the Company initially recorded a $401 beneficial conversion feature upon issuance based on the intrinsic value of the conversion feature, which resulted in a debt discount with a corresponding amount to additional paid in capital.

Debt discount related to the beneficial conversion feature was being amortized over the life of the Convertible Notes using the effective interest method as additional interest expense. The Company recorded interest expense of $8 and $16 for the three and six month periods ended June 30, 2019 , respectively, related to the debt discount.

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Notes to Condensed Consolidated Financial Statements

8. Stockholders’ Equity (Deficit)

Common Stock

The voting, dividend, and liquidation rights of the holders of the common stock are subject to and qualified by the rights, powers, and preferences of the holders of the preferred stock when outstanding. The holders of the common stock are entitled to one vote for each share of common stock held at all meetings of stockholders.

 

Dividend Rights

Common stock holders are entitled to receive dividends at the sole discretion of the board of directors of the Company. There have been no dividends declared on common stock as of June 30, 2020.

Voting Rights

The holders of common stock are entitled to one vote for each share of common stock along with all other classes and series of stock of the Company on all actions to be taken by the stockholders of the Company, including actions that would amend the certificate of incorporation of the Company to increase the number of authorized shares of the common stock.

Liquidation Rights

In the event of any liquidation, dissolution, or winding-up of the Company, the holders of common stock shall be entitled to share in the remaining assets of the Company available for distribution post preferential distributions made to holders of the Company’s preferred stock.

April 2020 Equity Financing

On April 13, 2020, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with an institutional investor, pursuant to which the Company sold, in a registered direct offering (the “Registered Offering”), 750,000 shares (the “Shares”) of the Company’s common stock at an offering price of $10 per share.

The Registered Offering resulted in gross proceeds of $7.5 million, before deducting the placement agent’s fees and related offering expenses. The Registered Offering closed on April 16, 2020.

In connection with the Registered Offering, the placement agent received a cash commission equal to 7% of the gross proceeds from the sale of the Common Stock and warrants (the “Placement Agent’s Warrants”) to purchase up to 37,500 shares of Common Stock, which represented 5.0% of the Shares sold in the Registered Offering. The Placement Agent’s Warrants have an exercise price of $12.50 per share, which represented 125% of the per share offering price of the Shares and a termination date of April 16, 2025. The fair value of the Placement Agent’s Warrants was $289 and was based on the Black-Scholes pricing model. Input assumptions used were as follows: a risk-free interest rate of 0.4%; expected volatility of 78.0%; expected life of 5 years; and expected dividend yield of 0%. The underlying traded stock price was used in the analysis. The Placement Agent’s Warrants were classified in stockholders’ equity as the number of shares were fixed and determinable and given that the Placement Agent’s Warrants did not require cash settlement or have other provisions precluding equity treatment.

During the three and six months ended June 30, 2020, issuance costs in connection with the Registered Offering were $1.0 million which included cash commissions equal to $0.5 million, legal and other fees of $0.2 million and Placement Agent’s Warrants with a value of $0.3 million.

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Notes to Condensed Consolidated Financial Statements

Warrants

The following warrants were outstanding as of June 30, 2020 and December 31, 2019:

Exercise Price

Number Outstanding

Expiration Date

Number Exercisable

$

186.75

1,440

July 2028

1,440

$

260.00

39,115

March 2022

39,115

Total outstanding December 31, 2019

40,555

40,555

$

12.50

37,500

April 2025

37,500

Total outstanding June 30, 2020

78,055

78,055

9. Stock-based Compensation

Stock-based compensation expense was included in general and administrative and research and development costs as follows in the accompanying statements of comprehensive loss (in thousands):

Three Months Ended

Six Months Ended

June 30, 

June 30, 

2020

    

2019

    

2020

    

2019

Research and development

$

4

$

16

$

18

$

55

General and administrative

167

63

312

84

Total stock-based compensation

$

171

$

79

$

330

$

139

Stock Options

2019 and 2018 Stock Plans

In December 2018, Private NeuroBo adopted the NeuroBo Pharmaceuticals, Inc. 2018 Stock Plan (the "2018 Plan") and in December 2019 in connection with the Merger, the Company adopted the 2019 Equity Incentive Plan (the “2019 Plan”). 2018 Plan options to purchase Private NeuroBo common stock outstanding as of immediately prior to the Merger were assumed by the Company upon the Merger and became options to purchase the Company’s common stock, as adjusted by the Exchange Ratio. The 2018 Plan and 2019 Plan provide for the grant of stock options, restricted stock and other equity awards of the Company's common stock to employees, officers, consultants, and directors. Options expire within a period of not more than ten years from the date of grant.

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NeuroBo Pharmaceuticals, Inc.

Notes to Condensed Consolidated Financial Statements

The following table summarizes the Company’s activity related to its stock options for the six months ended June 30, 2020 and 2019:

Six Months Ended

June 30, 

2020

2019

Outstanding on January 1

633,277

Granted

360,000

960,204

Exercised

(84,589)

Forfeited/Cancelled

Outstanding on June 30

908,688

960,204

During the six month periods ended June 30, 2020 and 2019, 360,000 and 960,204 stock options were granted, respectively, to employees, non-employee directors and non-employee consultants with both service and performance conditions. The options granted with service conditions vest quarterly over a period between one year and fifteen months. The total number of stock options outstanding as of June 30, 2020 and December 31, 2019 was 908,688 and 633,277, respectively. There were no stock options granted during the three month periods ended June 30, 2020 and 2019.

The weighted average fair value per share of options granted during the six month periods ended June 30, 2020 and 2019, was $5.59 and $0.50, respectively.

The Company measures the fair value of stock options with service-based and performance-based vesting criteria to employees, consultants and directors on the date of grant using the Black-Scholes option pricing model. The Company does not have history to support a calculation of volatility and expected term. As such, the Company has used a weighted-average volatility considering the volatilities of several guideline companies.

For purposes of identifying similar entities, the Company considered characteristics such as industry, length of trading history, and stage of life cycle. The assumed dividend yield was based on the Company’s expectation of not paying dividends in the foreseeable future. The average expected life of the options was determined based on the mid-point between the vesting date and the end of the contractual term according to the “simplified method” as described in Staff Accounting Bulletin 110. The risk-free interest rate is determined by reference to implied yields available from U.S. Treasury securities with a remaining term equal to the expected life assumed at the date of grant. The Company records forfeitures when they occur.

The weighted-average assumptions used in the Black-Scholes option-pricing model are as follows:

Six Months Ended

June 30,

    

2020

    

2019

Expected stock price volatility

77.5

%

75.0

%

Expected life of options (years)

5.8

10.0

Expected dividend yield

0

%

0

%

Risk free interest rate

1.71

%

2.75

%

Evergreen provision

Under the 2019 Plan, the shares reserved automatically increase on January 1st of each year, for a period of not more than ten years commencing on January 1, 2020 and ending on (and including) January 1, 2029, to an amount equal to the

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NeuroBo Pharmaceuticals, Inc.

Notes to Condensed Consolidated Financial Statements

lesser of 4% of the common shares outstanding as of January 1st , or a lesser amount as determined by the Board. The aggregate maximum number of shares of common stock that may be issued pursuant to the 2019 Plan under the evergreen provision is 6,680,000 shares of common stock. On January 1, 2020, 623,708 shares were added to the 2019 Plan as a result of the evergreen provision.

During the three month periods ended June 30, 2020 and 2019, 44,289 and 37,150 stock options vested, respectively, and 87,151 and 157,176 stock options vested during the six month periods ended June 30, 2020 and 2019, respectively. During the three and six month periods ended June 30, 2020 and 2019, no stock options were forfeited.

As of June 30, 2020, 4,127,179 shares in the aggregate were available for future issuance under the 2019 Plan and 2018 Plan.

Unrecognized stock-based compensation cost for the stock options issued under the both the Company’s 2019 Plan and 2018 Plan was $1.7 million as of June 30, 2020. The unrecognized stock-based expense is expected to be recognized over a weighted average period of 2.5 years.

10. Redeemable Preferred Stock (in thousands, except share and per share data)

Upon close of the Merger on December 30, 2019, 8,264,613 shares of Private NeuroBo Series A and Series B redeemable preferred stock (as adjusted for the Exchange Ratio) were converted to Private NeuroBo common stock on a 1:1 basis. Previously in April 2018, Private NeuroBo sold and issued in a private placement 4,801,020 shares of Series A redeemable convertible preferred stock (as adjusted for the Exchange Ratio) at $3.50 per share, raising $16,800 in gross proceeds. Subsequently in May and June 2019, Private NeuroBo sold and issued 3,463,593 Series B redeemable convertible preferred stock (as adjusted for the Exchange Ratio) at $7.00 per share, raising $24,240 in gross proceeds.

While outstanding, the redeemable preferred stock was classified outside of stockholders' equity (deficit) because the shares contained certain redemption features that were not solely within the control of the Company. Private NeuroBo did not adjust the carrying values of the convertible preferred stock to the liquidation preferences of such shares because the occurrence of any such change of control event was not deemed probable.

11. Net Loss Per Common Share

Basic net loss per share is computed by dividing the net loss by the weighted-average number of common shares outstanding for the period, without consideration for potentially dilutive securities if their effect is antidilutive. Diluted net loss per share is computed by dividing the net loss by the weighted average number of shares of common stock and dilutive common stock equivalents outstanding for the period determined using the treasury stock and if-converted methods. Dilutive common stock equivalents are comprised of convertible preferred stock, convertible notes payable, options outstanding under the Company's stock option plan and warrants. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding as inclusion of the potentially dilutive securities would be antidilutive.

The following potential common shares were not considered in the computation of diluted net loss per share as their effect would have been anti-dilutive:

Three Months Ended

Six Months Ended

 

June 30,

June 30,

    

2020

    

2019

    

2020

    

2019

 

Redeemable preferred stock

8,264,613

8,264,613

Convertible notes

 

1,531,268

 

 

1,531,268

Stock options

908,688

960,204

908,688

960,204

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NeuroBo Pharmaceuticals, Inc.

Notes to Condensed Consolidated Financial Statements

Warrants

78,055

78,055

12. Income Taxes

The effective tax rate for the three and six month periods ended June 30, 2020 and 2019 was zero percent. As a result of the analysis of all available evidence as of June 30, 2020 and December 31, 2019, the Company recorded a full valuation allowance on its net deferred tax assets. Consequently, the Company reported no income tax benefit for the three and six month periods ended June 30, 2020 and 2019. If the Company’s assumptions change and the Company believes that it will be able to realize these deferred tax assets, the tax benefits relating to any reversal of the valuation allowance on deferred tax assets will be recognized as a reduction of future income tax expense.  If the assumptions do not change, each period the Company could record an additional valuation allowance on any increases in the deferred tax assets.

On March 27, 2020, the U.S. government enacted the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”) which includes modifications to the limitation on business interest expense and net operating loss provisions, and provides a payment delay of employer payroll taxes during 2020 after the date of enactment. The CARES Act is not expected to have a material impact on the Company’s consolidated financial statements.

13. Related Party Transactions (in thousands, except per share data)

On September 28, 2018, Private NeuroBo entered into a five year manufacturing and supply agreement with Dong-A ST for manufacturing and supply of NB-01 drug substance and placebos for the purpose of research and development to be used in Phase 3 clinical trials (the “Manufacturing Agreement”). The Company recognized no product manufacturing related costs under the Manufacturing Agreement for the three month and six month periods ended June 30, 2020, and $309 and $314 during the three and six month periods ended June 30, 2019, respectively. The product manufacturing related costs, when incurred, are reflected as research and development expenses.

The Manufacturing Agreement will automatically terminate in the event that the license agreement with Dong-A ST is terminated for any reason. In addition, each of Dong-A ST and Private NeuroBo may terminate the Manufacturing Agreement (1) upon the material breach by the other party, if the breach is not cured within a specified number of days after receiving notice from the terminating party, or if the breach cannot reasonably be cured within such period and the breaching party has not started to remedy the breach within such period and diligently endeavored to cure the breach within a reasonable time thereafter, or (2) in the event that (i) the other party is the subject of a petition for bankruptcy, reorganization, or arrangement and the same is not dismissed within thirty days thereof, (ii) a receiver or trustee is appointed for all or a substantial portion of the assets of the other party, or (iii) the other party makes an assignment for the benefit of its creditors.

On June 7, 2020, the Company entered into a manufacturing and supply agreement (the “Manufacturing and Supply Agreement”) with Dong-A ST for the manufacturing and supply of NB-02 drug product and placebo for the purpose of research and development of NB-02, including but not limited to, the use in the first NB-02 human clinical trial to be conducted by the Company. Under the terms of the Manufacturing and Supply Agreement, upon receipt of a purchase order from the Company no later than 270 days prior to the requested delivery date, Dong-A ST has agreed to produce for the Company tablets of the NB-02 drug substance and placebos at a specified supply price. The Company is obligated to manufacture, or have manufactured, and supply to Dong-A the active pharmaceutical ingredients which are necessary to manufacture the NB-02 drug product. The Manufacturing and Supply Agreement has a five year term, subject to earlier termination under certain circumstances.

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NeuroBo Pharmaceuticals, Inc.

Form 10-Q

ITEM 2.

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion of our financial condition and results of operations should be read in conjunction with the condensed financial statements and related notes included elsewhere in this report and the audited financial statements and related notes for the fiscal year ended December 31, 2019 included in our Annual Report on Form 10-K (“2019 Form 10-K”) filed on March 30, 2020.

Forward-Looking Statements

Certain statements contained in this Quarterly Report on Form 10-Q are not statements of historical fact and are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Forward-looking statements give current expectations or forecasts of future events or our future financial or operating performance. All statements other than statements of historical facts contained in this Quarterly Report on Form 10-Q are forward-looking statements. We may, in some cases, use words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “target,” “contemplate,” “potential,” “predict,” “project,” “should,” “will,” “would” or the negative of those terms, and similar expressions that convey uncertainty of future events or outcomes to identify these forward-looking statements.

These forward-looking statements reflect our management’s beliefs and views with respect to future events, are based on estimates and assumptions as of the date of this report and are subject to known and unknown risks and uncertainties, many of which are beyond our control, that could cause our actual results to differ materially from those in these forward-looking statements. We discuss many of these risks in greater detail under Part I, Item 1A “Risk Factors” in our 2019 Form 10-K filed on March 30, 2020 and in subsequent reports filed with or furnished to the SEC. Moreover, we operate in a very competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward-looking statements.

Any forward-looking statement made by us in this report speaks only as of the date hereof or as of the date specified herein. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments, changed circumstances or otherwise, except as may be required by applicable laws or regulations.

Overview

NeuroBo Pharmaceuticals Inc. (the “Company,” “we,” “us” or “our”) is a clinical-stage biotechnology company focused on developing and commercializing novel pharmaceuticals to treat neurodegenerative disorders affecting millions of patients worldwide. For more information on our business and our three product candidates, NB-01, NB-02 and Gemcabene, see “Business-Overview” in Part I, Item 1 of our Annual Report on From 10-K filed on March 30, 2020. On July 24, 2019, Gemphire Therapeutics Inc. (“Gemphire”), and NeuroBo Pharmaceuticals, Inc. (“Private NeuroBo”) entered into a definitive merger agreement, which was amended on October 29, 2019 (the “Merger Agreement”). The merger closed on December 30, 2019 (the “Effective Date”), whereby Private NeuroBo merged with a wholly-owned subsidiary of the Company in an all-stock transaction (the “Merger”).

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NeuroBo Pharmaceuticals, Inc.

Form 10-Q

Recent Developments

COVID-19

We are subject to risks and uncertainties as a result of the COVID-19 pandemic. The extent of the impact of the COVID-19 pandemic on our business is highly uncertain and difficult to predict, as the responses that we, other businesses and governments are taking continue to evolve. Furthermore, capital markets and economies worldwide have also been negatively impacted by the COVID-19 pandemic, and it is possible that it could cause a lasting national or global economic recession. Policymakers around the globe have responded with fiscal policy actions to support the healthcare industry and economy as a whole. The magnitude and overall effectiveness of these actions remain uncertain.

To date, except for the adjustments to scientific activity described under “Current Scientific Activity” below, we have not experienced any significant changes in our business that would have a significant negative impact on our consolidated statements of operations or cash flows.

The severity of the impact of the COVID-19 pandemic on our business will depend on a number of factors, including, but not limited to, the duration and severity of the pandemic and the extent and severity of the impact on our service providers, suppliers, contract research organizations and our clinical trials, all of which are uncertain and cannot be predicted. As of the date of issuance of our financial statements, the extent to which the COVID-19 pandemic may in the future materially impact our financial condition, liquidity or results of operations is uncertain.

Current Scientific Activity

In light of the present business environment, including the impact of the COVID-19 virus that emerged in December 2019 and became a global pandemic, we are currently conducting the scientific activities described below with a view toward conserving financial resources.

For NB-01, we have determined that any attempt to conduct Phase 3 clinical trials, as previously announced, would be difficult if not impossible in the short or medium term. Accordingly, in the first quarter of 2020, we directed our contract research organization (“CRO”) partners and other vendors working on the Phase 3 clinical trials of NB-01 to cease all work and we terminated our existing contract arrangements with each of them.

We are currently devoting scientific resources to evaluating the potential to bring the NB-01 asset to the market through a different regulatory pathway. Development of NB-01 as an orphan drug is among the alternatives we are considering, and we may conduct feasibility studies to identify a rare disease relevant to NB-01. There is no assurance that we will be able to pursue any orphan drug indication for NB-01. We also considered marketing NB-01 as a nutraceutical (non-pharmaceutical) product but we have determined not to pursue such pathway at this time. See the risk factor entitled “We have determined to postpone indefinitely the initiation of Phase 3 clinical trials of NB-01 under present circumstances, and we may not be able to successfully develop NB-01 pursuant to other alternatives, including as an orphan drug” in Part II, Item 1A “Risk Factors” below.

The Company is preparing an Investigational New Drug (“IND”) application to the U.S. Food and Drug Administration (“FDA”) for NB-02. The Company intends to postpone the first human clinical trials for NB-02 until global health and macroeconomic conditions improve, with a view toward commencing clinical trial activity in the first half of 2021, subject to improvement of the constraints imposed by the COVID-19 pandemic. The Company is also considering engaging with a strategic partner to assist with clinical trials for NB-02.

In May 2020, we received written communication from the U.S. Food and Drug Administration (“FDA”) that the clinical development program for Gemcabene remains on a partial clinical hold. The Company is reviewing its options regarding Gemcabene.

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NeuroBo Pharmaceuticals, Inc.

Form 10-Q

As of June 30, 2020, we had cash and cash equivalents of $14.3 million. Operating at such level of scientific activity, we expect that our cash, including the net proceeds from the Registered Offering, will be adequate to fund operations into the second quarter of 2021.

We will need to raise additional capital to fund continued operations at the current level through the second quarter of 2021 and beyond. Although we are exploring financing opportunities and carefully monitoring the capital markets, we do not yet have any commitments for additional financing and may not be successful in our efforts to raise additional funds. Any amounts raised will be used for further development of our product candidates and for other working capital purposes and, depending on the amount raised, for commencing clinical activity on NB-02 in the first half of 2021.

If we are unable to raise additional capital (which is not assured at this time, particularly as a result of recent depressed capital market conditions), our long-term business plan may not be accomplished, and we may be forced to cease, reduce, or delay operations. We have some ability to reduce costs further in 2020 and 2021, thereby potentially lengthening our operational window into the third quarter of 2021.

Going Concern

The accompanying condensed consolidated financial statements have been prepared in conformity with GAAP, which contemplate our continuation as a going concern. We have not established a source of revenues and, as such, have been dependent on funding operations through the sale of equity securities. Since inception, we have experienced significant losses and incurred negative cash flows from operations. We expect to incur further losses over the next several years as we develop our business. We have spent, and expect to continue to spend, a substantial amount of funds in connection with implementing our business strategy.

We will need substantial additional funding to support our continuing operations and to pursue our business strategy and, in the meantime, we have reduced scientific activity (as indicated above) and we are carefully controlling expenses. Until such time as we can generate significant revenue from product sales, if ever, we expect to continue to finance our operations primarily through proceeds derived from the sale of equity.

These factors individually and collectively raise substantial doubt about our ability to continue as a going concern. Our financial statements do not include any adjustments or classifications that may result from our possible inability to continue as a going concern. The report of our independent registered public accounting firm on our financial statements for the year ended December 31, 2019 includes an explanatory paragraph regarding the existence of substantial doubt about our ability to continue as a going concern.

Key operating data

         We have incurred significant operating losses since inception. Our ability to generate product revenue sufficient to achieve profitability will depend on the successful development and eventual commercialization of one or more of our current or future product candidates. Our net losses were $2.4 million and $1.9 million for the three months ended June 30, 2020 and 2019, respectively, and $7.1 million and $4.4 million for the six months ended June 30, 2020 and 2019, respectively. To date, we have not generated any revenue from product sales, collaborations with other companies, government grants or any other source, and do not expect to generate any revenue in the foreseeable future.

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NeuroBo Pharmaceuticals, Inc.

Form 10-Q

As of June 30, 2020, we had an accumulated deficit of $44.0 million. We expect to continue to incur significant expenses and increasing operating losses for at least the next several years. We expect that our expenses and capital requirements will increase substantially in connection with our ongoing activities, particularly if and as we:

pursue clinical development for any of our current product candidates;
initiate preclinical studies and clinical trials with respect to any additional indications for our current product candidates and any future product candidates that we may pursue;
acquire or in-license other product candidates and/or technologies;
develop, maintain, expand and protect our intellectual property portfolio;
hire additional clinical, scientific and commercial personnel;
establish a commercial manufacturing source and secure supply chain capacity sufficient to provide commercial quantities of any product candidates for which we may obtain regulatory approval;
seek regulatory approvals for any product candidates that successfully complete clinical trials;
establish a sales, marketing and distribution infrastructure and/or enter into partnership arrangements to commercialize any products for which we may obtain regulatory approval; or
add administrative, operational, financial and management information systems and personnel, including personnel to support our product development and planned future commercialization efforts, and to support our transition to a public reporting company.

Components of Results of Operations

Operating Expenses

Research and Development Expenses

         Research and development expenses consist primarily of costs incurred in connection with the development of our product candidates. We expense research and development costs to operations as incurred. These expenses include:

employee-related expenses, including salaries, related benefits and stock-based compensation, for employees engaged in research and development functions;
expenses incurred in connection with the clinical development of our product candidates, including under agreements with third parties, such as consultants and Clinical Research Organizations (“CROs”);
the cost of manufacturing and storing drug products for use in our preclinical studies and clinical trials, including under agreements with third parties, such as consultants and Clinical Manufacturing Organizations (“CMOs”);
facilities, depreciation and other expenses, which include direct or allocated expenses for rent and maintenance of facilities and insurance;
costs related to compliance with regulatory requirements; and
payments made under third-party licensing agreements.

         We recognize external development costs based on an evaluation of the progress toward completion of specific tasks using information provided to us by our service providers. This process involves reviewing open contracts and purchase orders, communicating with our personnel to identify services that have been performed on our behalf, and estimating the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of actual costs. Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses. Such amounts are recognized as an expense when the goods have been delivered or the services have been performed, or when it is no longer expected that the goods will be delivered, or the services rendered.

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NeuroBo Pharmaceuticals, Inc.

Form 10-Q

         Our direct research and development expenses consist primarily of external costs, such as fees paid to outside consultants, CROs, CMOs and research laboratories in connection with our clinical development, quality assurance and quality control processes, manufacturing, and clinical development activities. Our direct research and development expenses also include fees incurred under third-party license agreements. We use our employee and infrastructure resources across multiple research and development projects. We do not allocate employee costs and costs associated with our facilities, including depreciation or other indirect costs, to specific product candidates because these costs are deployed across multiple programs and, as such, are not separately classified. We use internal resources primarily to conduct manufacturing and clinical development activities. These employees work across multiple programs and, therefore, we do not track our costs by product candidate.

         Clinical development activities are central to our business model. We do not believe that our historical costs are indicative of the future costs associated with these programs, nor do they represent the costs of other future programs we may initiate. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. We have some control over the timing of these expenses, but costs may be difficult to control once clinical trials have commenced.

The successful development and commercialization of our product candidates are highly uncertain. At this time, we cannot reasonably estimate or know the nature, timing and costs of the efforts that will be necessary to complete the preclinical and clinical development of any of our product candidates. Additionally, because of the risks inherent in novel treatment discovery and development, we cannot reasonably estimate or know:

the timing and progress of preclinical and clinical development activities;
the number and scope of clinical programs that we decide to pursue;
our ability to maintain our current development programs and to establish new ones;
establishing an appropriate safety profile with IND-enabling studies;
successful patient enrollment in, and the initiation and completion of, clinical trials;
the successful completion of clinical trials with safety, tolerability and efficacy profiles that are satisfactory to the FDA or any comparable foreign regulatory authority;
the receipt of regulatory approvals from applicable regulatory authorities;
the timing, receipt and terms of any marketing approvals from applicable regulatory authorities;
our ability to establish new licensing or collaboration arrangements;
establishing agreements with third-party manufacturers for clinical supply for our clinical trials and commercial manufacturing, if any of our product candidates is approved;
development and timely delivery of clinical-grade and commercial-grade drug formulations that can be used in our clinical trials and for commercial launch;
obtaining, maintaining, defending and enforcing patent claims and other intellectual property rights;
launching commercial sales of our product candidates, if approved, whether alone or in collaboration with others;
maintaining a continued acceptable safety profile of the product candidates following commercialization; or
the effect of competing technological and market developments.

         A change in the outcome of any of these variables with respect to the development of our product candidates could significantly change the costs and timing associated with the development of that product candidate.

General and Administrative Expenses

         General and administrative expenses consist primarily of salaries and related costs, including stock-based compensation, for personnel in executive, finance and administrative functions. General and administrative expenses also

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NeuroBo Pharmaceuticals, Inc.

Form 10-Q

include direct and allocated facility-related costs as well as professional fees for legal, patent, consulting, investor and public relations, accounting, and audit services.

         We anticipate that our general and administrative expenses will increase in the future as a result of accounting, audit, legal, regulatory, compliance, and director and officer insurance costs as well as investor and public relations expenses associated with being a public company. Some of these increases may be offset by decreased expenses associated with the change in strategy for NB-01 and Gemcabene.

Interest Income (Expense), net

Interest Expense

       Interest expense consists of the interest calculated at a rate of 5% per annum on the convertible notes issued by Private NeuroBo in February 2018 and debt discount amortization attributed to the underlying beneficial conversion features of the convertible notes. The convertible notes were converted into shares of common stock in connection with the Merger.

Interest Income

  Interest income consists of bank interest earned on our cash and cash equivalents.

Other (Expense) Income, net

Other (expense) income, net reflects non-operating expenses associated mainly with realized foreign currency exchange gains and losses.

 

Results of Operations

The following table summarizes our operating results for the periods indicated:

For the Three Months Ended

For the Six Months Ended

 

June 30, 

June 30, 

    

2020

    

2019

    

Change

    

2020

    

2019

    

Change

(in thousands)

Operating expenses:

Research and development

$

674

$

948

$

(274)

$

2,826

$

2,748

$

78

General and administrative

 

1,718

 

939

 

779

 

4,315

 

1,590

 

2,725

Total operating expenses

 

2,392

 

1,887

 

505

 

7,141

 

4,338

 

2,803

Loss from operations

 

(2,392)

 

(1,887)

 

(505)

 

(7,141)

 

(4,338)

 

(2,803)

Interest income (expense), net

 

8

 

(14)

 

22

 

28

 

(27)

 

55

Other expense, net

 

 

 

 

(1)

 

 

(1)

Loss before income taxes

(2,384)

(1,901)

(483)

(7,114)

(4,365)

(2,749)

Provision for income taxes

Net loss

$

(2,384)

$

(1,901)

$

(483)

$

(7,114)

$

(4,365)

$

(2,749)

Comparison of Three Months Ended June 30, 2020 and 2019

Research and Development Expenses

Research and development expenses were $0.7 million for the three months ended June 30, 2020 as compared to $0.9 million for the three months ended June 30, 2019. The $0.3 million decrease in the second quarter of 2020 was

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Form 10-Q

primarily attributed to the overall reduction of clinical trial activity given the determination in March 2020 to postpone Phase 3 clinical trials of NB-01. Research and development expenses during the three months ended June 30, 2020 and 2019 included stock-based compensation of $4,000 and $16,000, respectively.

General and Administrative Expenses

General and administrative expenses were $1.7 million for the three months ended June 30, 2020, compared to $0.9 million for the three months ended June 30, 2019. The increase of $0.8 million was primarily due to operating as a public company and to post-Merger support costs in the second quarter of 2020 when compared to the comparable quarter in the prior year. The cost increases in the current quarter included $0.1 million in audit and external accounting support, $0.4 million in director and officer insurance premiums, $0.2 million in board of director and other public company costs and $0.1 million of stock based compensation and miscellaneous net operational cost increases. Stock-based compensation costs during the three month periods ended June 30, 2020 and 2019 were $0.2 million and $63,000, respectively.

Interest Income (Expense), net

Interest income for the three month period ended June 30, 2020 was $8,000 related to cash deposits. The Company did not incur interest expenses during the second quarter of 2020 as there was no debt outstanding during the period.

Interest expense, net during the three month period ended June 30, 2019 included non-cash interest expense in connection with our convertible notes of $15,000 offset in part by interest income of less than $1,000 related to cash deposits. Non-cash interest expense during the three month period ended June 30, 2019 consisted of interest on principal in the amount of $7,000 and costs attributed to the underlying beneficial conversion features of the convertible notes in the form of discount amortization in the amount of $8,000.

Other Expense, net

        Other expense, net incurred during the three month periods ended June 30, 2020 and 2019 was nominal.

Comparison of Six Months Ended June 30, 2020 and 2019

Research and Development Expenses

Research and development expenses were $2.8 million for the six months ended June 30, 2020 as compared to $2.7 million for the six months ended June 30, 2019. The $0.1 million increase in 2020 was primarily attributed to the CRO termination costs associated with the determination in March 2020 to postpone Phase 3 clinical trials of NB-01 in the amount of $0.7 million, and to the further development of Gemcabene under the Contingent Value Rights Agreement in the amount of $0.8 million, offset largely by the overall reduction of clinical trial activity in 2020 when compared to the comparable period in the prior year. Research and development expenses during the six months ended June 30, 2020 and 2019 included stock-based compensation of $18,000 and $55,000, respectively.

General and Administrative Expenses

General and administrative expenses were $4.3 million for the six months ended June 30, 2020, compared to $1.6 million for the six months ended June 30, 2019. The increase of $2.7 million was primarily due to operating as a public company and to post-Merger support costs in the first and second quarters of 2020 when compared to the comparable quarters in the prior year. The cost increases in 2020 included $0.8 million in legal costs, $0.5 million in audit and external accounting support, $0.8 million in director and officer insurance premiums, $0.3 million in board of director and other public company costs, $0.2 million in stock-based compensation and $0.1 million in miscellaneous net

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Form 10-Q

operational costs increases. Stock-based compensation costs during the six month periods ended June 30, 2020 and 2019 were $0.3 million and $0.1 million, respectively.

Interest Income (Expense), net

Interest income for the six month period ended June 30, 2020 was $28,000 related to cash deposits. The Company did not incur interest expenses during the six months ended June 30, 2020 as there was no debt outstanding during the period.

Interest expense, net during the six month period ended June 30, 2019 included non-cash interest expense in connection with our convertible notes of $29,000 offset in part by interest income of $2,000 related to cash deposits. Non-cash interest expense during the six month period ended June 30, 2019 consisted of interest on principal in the amount of $13,000 and costs attributed to the underlying beneficial conversion features of the convertible notes in the form of discount amortization in the amount of $16,000.

Other Expense, net

        Other expense, net was $1,000 during the six month period ended June 30, 2020, compared to a nominal amount during the six month period ended June 30, 2019. The net change of $1,000 was due to a fluctuations in realized foreign currency exchange gains and losses period over period.

Liquidity and Capital Resources

Prior to the Merger, Private NeuroBo funded operations with proceeds from sales of preferred stock and proceeds from the issuance of convertible debt. Prior to the Merger, Private NeuroBo received net proceeds of $40.9 million from sales of preferred stock and $0.5 million from the sales of convertible notes which were converted into shares of Private NeuroBo common stock, effective immediately prior to the closing of the Merger.

        ln April 2018, Private NeuroBo issued an aggregate of 4,801,020 shares of Series A preferred stock (as adjusted for the exchange ratio (“Exchange Ratio”) in connection with the Merger), at a purchase price of $3.50 per share, for aggregate gross consideration of approximately $16.8 million. On December 30, 2019, each share of Series A preferred stock then outstanding was converted into common stock in accordance with the terms of the Merger Agreement.

        ln August 2019, Private NeuroBo issued an aggregate of 3,463,593 shares of Series B preferred stock (as adjusted for the Exchange Ratio) at a purchase price of $7.00 per share, for aggregate gross consideration of approximately $24.2 million. On December 30, 2019, each share of Series B preferred stock then outstanding was converted into common stock in accordance with the terms of the Merger Agreement.

On April 13, 2020, we entered into a Securities Purchase Agreement with an institutional investor, pursuant to which we sold in a registered direct offering (the “Registered Offering”) 750,000 shares of our common stock, at an offering price of $10.00 per share. The Registered Offering resulted in gross proceeds of $7.5 million, before deducting the placement agent’s fees and related offering expenses.

Since inception, we have experienced significant losses and incurred negative cash flows from operations. We expect to incur further losses over the next several years as we develop our business. We have spent, and expect to continue to spend, a substantial amount of funds in connection with implementing our business strategy.

We will need substantial additional funding to support our continuing operations and to pursue our business strategy and, in the meantime, we have reduced scientific activity, as described under “Overview – Reduced Scientific Activity; Repurposing of NB-01” above, and we are carefully controlling expenses. In the first quarter of 2020, in connection with the reduced scientific activity, we directed our CRO partners and other vendors working on the Phase 3

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clinical trials of NB-01 to cease all work and have terminated our existing contract arrangements with each of them. In accordance with ASC 450, Contingencies, we have determined that it is reasonably possible that a loss has occurred with respect to these invoiced amounts and estimate the range of loss as $0 to $1.1 million. Since no amount in this range is a better estimate than any other amount within the range, we have not accrued any liability arising from potential losses relating to these disputed termination charges.

As of June 30, 2020, we had cash and cash equivalents of $14.3 million. Operating at such level of scientific activity, we expect that our cash, including the net proceeds from the Registered Offering, will be adequate to fund operations into the second quarter of 2021.

We will need to raise additional capital to fund continued operations at the current level through the second quarter of 2021 and beyond. Although we are exploring financing opportunities and carefully monitoring the capital markets, we do not yet have any commitments for additional financing and may not be successful in our efforts to raise additional funds. If we are unable to raise additional capital (which is not assured at this time, particularly as a result of recent depressed capital market conditions), our long-term business plan may not be accomplished, and we may be forced to cease, reduce, or delay operations. We have some ability to reduce costs further in 2020 and 2021, thereby potentially lengthening our operational window into the third quarter of 2021.

Cash Flows

The following table summarizes our cash flows for the periods indicated:

For the Six Months Ended

June 30, 

    

2020

2019

   

(in thousands)

Net cash used in operating activities

$

(6,462)

$

(2,416)

Net cash used in investing activities

 

(2)

(25)

Net cash provided by financing activities

 

6,858

24,175

Net increase in cash and restricted cash

$

394

$

21,734

Operating Activities

        During the six month period ended June 30, 2020, operating activities used $6.5 million of cash, primarily resulting from our net loss of $7.1 million offset by non-cash expenses related to stock-based compensation and depreciation in the aggregate of $0.4 million. Net cash provided by changes in our operating assets and liabilities for the six month period ended June 30, 2020 was $0.3 million which consisted of an increase in accounts payable and accrued expenses of $1.1 million, offset in part by an increase in prepaid expenses and other current assets of approximately $0.8 million. The increase in prepaid expenses and other current assets was primarily due to the payment of insurance premiums. The net increase in accounts payable and accrued expenses was primarily attributed to the timing of vendor invoicing and payments.

During the six months ended June 30, 2019, operating activities used $2.4 million of cash, primarily resulting from a net loss of $4.4 million , offset by non-cash expenses relating to stock-based compensation, interest and depreciation in the aggregate of $0.2 million. Net cash provided by changes in operating assets and liabilities for the six months ended June 30, 2019 amounted to $1.8 million and consisted of a decrease in prepaid expenses and other current assets of $0.9 million and a $0.9 million increase in accrued expenses and payables. The decrease in prepaid expenses and other current assets was primarily due to the expensing of prepaid amounts paid to CROs for clinical trial activities. The increase in accrued expenses was primarily due to increases in development costs for clinical trial activities and increases in bonus accruals.

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Investing Activities

During the six month period ended June 30, 2020, net cash used in investing activities was $2,000. Investing activities during the period consisted of purchases of property and equipment.  During the six months ended June 30, 2019, net cash used in investing activities was less than $0.1 million, consisting of purchases of property and equipment.

Financing Activities

        During the six month period ended June 30, 2020, net cash provided by financing activities was $6.9 million, consisting of proceeds from the Registered Offering of $6.8 million, net of issuance costs, and from the exercise of stock options of $53,000. During the six months ended June 30, 2019, net cash provided by financing activities was $24.2 million, consisting entirely of net proceeds of $24.2 million from the sale by Private NeuroBo of Series B preferred stock in May and June 2019.

        Funding Requirements

         We expect to incur additional costs associated with operating as a public company. In addition, we expect our expenses to increase substantially over time in connection with our ongoing activities, particularly as we advance the preclinical activities and clinical trials of our product candidates. The timing and amount of our preclinical and clinical expenditures will depend largely on:

the availability of capital;
the scope, number, initiation, progress, timing, costs, design, duration, any potential delays, and results of clinical trials and nonclinical studies for our current or future product candidates;
the clinical development plans we establish for our product candidates;
the number and characteristics of product candidates and programs that we develop or may in-license;
the outcome, timing and cost of regulatory reviews, approvals or other actions to meet regulatory requirements established by the FDA and comparable foreign regulatory authorities, including the potential for the FDA or comparable foreign regulatory authorities to require that we perform more studies for our product candidates than those that we currently expect;
our ability to obtain marketing approval for our product candidates;
the cost of filing, prosecuting, defending and enforcing our patent claims and other intellectual property rights covering our product candidates, including any such patent claims and intellectual property rights that we have licensed pursuant to the terms of our license agreement;
our ability to maintain, expand and defend the scope of our intellectual property portfolio, including the cost of defending intellectual property disputes, including patent infringement actions brought by third parties against us or our product candidates;
the cost and timing of completion of commercial-scale outsourced manufacturing activities with respect to our product candidates;
our ability to establish and maintain licensing, collaboration or similar arrangements on favorable terms and whether and to what extent we retain development or commercialization responsibilities under any new licensing, collaboration or similar arrangement;
the cost of establishing sales, marketing and distribution capabilities for any product candidates for which we may receive regulatory approval in regions where we choose to commercialize our products on our own;
the success of any other business, product or technology that we acquire or in which we invest;
the costs of acquiring, licensing or investing in businesses, product candidates and technologies; and
our need and ability to hire additional management and scientific and medical personnel.

We expect that, with current levels of scientific activity, our existing cash and cash equivalents will be sufficient to fund our operating expenses and capital expenditure requirements into the second quarter of 2021. We have based this

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estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect.

Critical Accounting Policies and Estimates

Our financial statements are prepared in accordance with GAAP. These accounting principles require us to make estimates and judgments that can affect the reported amounts of assets and liabilities as of the date of the financial statements as well as the reported amounts of revenue and expense during the periods presented. We believe that the estimates and judgments upon which we rely are reasonably based upon information available to us at the time that we make these estimates and judgments. To the extent that there are material differences between these estimates and actual results, our financial results will be affected. The accounting policies that reflect our more significant estimates and judgments and which we believe are the most critical to aid in fully understanding and evaluating our reported financial results are described in Note 2 — Summary of Significant Accounting Policies to our condensed consolidated financial statements included elsewhere in this report.

During the three months ended June 30, 2020, there were no material changes to our critical accounting policies or estimates disclosed in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our 2019 Form 10-K filed on March 30, 2020.

Off-Balance Sheet Arrangements

We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements as defined under the rules and regulations of the Securities and Exchange Commission.

Recent Accounting Pronouncements

Refer to Note 2— Summary of Significant Accounting Policies to our condensed consolidated financial statements included elsewhere in this report for a discussion of recently issued accounting pronouncements.

ITEM 3.QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Not applicable.

ITEM 4.CONTROLS AND PROCEDURES

Evaluation of Disclosure Controls and Procedures

We maintain disclosure controls and procedures that are designed to ensure that information we are required to disclose in our Exchange Act reports is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our principal executive and financial officer, as appropriate, to allow timely decisions regarding required disclosure.

We designed and evaluate our disclosure controls and procedures recognizing that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance and not absolute assurance of achieving the desired control objectives. Also, the design of a control system must reflect the fact that there are resource constraints and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that misstatements due to error or fraud will not occur or that all control issues and instances of fraud, if any, have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty and that breakdowns can occur because of simple error or mistake. The design of any system of controls is based, in part, upon certain assumptions about the likelihood of future events and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions.

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Under the supervision of and with the participation of our management, including our principal executive and financial officer, we evaluated the effectiveness of our disclosure controls and procedures, as such term is defined in Rules 13a-15(e) and 15(d)- 15(e) promulgated under the Exchange Act as of June 30, 2020. Based on this evaluation, our Chief Executive Officer and Principal Financial Officer concluded that our disclosure controls and procedures were not effective as of June 30, 2020 as a result of the material weakness described below and previously reported in our 2019 Form 10-K.

In connection with management’s assessment of the effectiveness of our internal control over financial reporting at the end of our last fiscal year, management identified a material weakness in our internal control over financial reporting as of December 31, 2019, which is in the process of being remediated as of June 30, 2020. The material weakness related to internal control deficiencies relating to accounting for clinical trial costs and related supply materials. A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis. Specifically, for 2018 there were material correcting journal entries related to our accounting for the timing of clinical trial costs, and for 2019 and the six months ended June 30, 2020, there were misstatements in clinical prepaids and expenses that were discovered during the audit/review process and would not have been detected by our internal control over financial reporting. See “Remediation Efforts to Address Material Weakness” below for steps we are taking to correct this material weakness.

 

Notwithstanding the identified material weakness, management, including our PEO and PFO, believes the consolidated financial statements included in this quarterly report fairly represent in all material respects our financial condition, results of operations and cash flows as of and for the periods presented in accordance with US. GAAP.

Changes in Internal Control Over Financial Reporting

Except as provided below under “Remediation Efforts to Address Material Weakness,” there were no changes in our internal control over financial reporting (as defined in Rule 13a-15(f) under the Exchange Act) during the quarter ended June 30, 2020, that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.

Remediation Efforts to Address Material Weakness

We are in the process of remediating, but have not yet remediated, the material weakness described above. Under the oversight of the audit committee, management is developing a detailed plan and timetable for the implementation of appropriate remedial measures to address the material weakness. As of the date of this quarterly report, we have taken the following actions and are in the process of making the following changes in our internal control environment to help remediate the material weakness:

we are adding more experienced accounting personnel, including an outside consultant, directly responsible for the oversight of the accounting for clinical trial expenses including the identification of and accounting for contracts entered into related to clinical trials;
we are improving processes in the area of clinical site expense monitoring; and
we are retaining additional qualified outside consultants, where necessary, to advise on highly complex technical accounting matters.

Management may decide to take additional measures to remediate the material weakness as necessary.

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PART II — OTHER INFORMATION

ITEM 1.LEGAL PROCEEDINGS

From time to time, we may be involved in various claims and legal proceedings relating to claims arising out of our operations. We are not currently a party to any legal proceedings that, in the opinion of our management, are likely to have a material adverse effect on our business. Regardless of outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.

ITEM 1A.RISK FACTORS

Our business, financial condition, results of operations, and cash flows may be impacted by a number of factors, many of which are beyond our control, including those set forth in our 2019 Form 10-K, the occurrence of any one of which could have a material adverse effect on our actual results.

 

There have been no material changes to the Risk Factors previously disclosed in our 2019 Form 10-K, except as noted below.

We have determined to postpone the initiation of Phase 3 clinical trials of NB-01 under present circumstances and we have terminated all of our agreements with contract research organizations related to NB-01. We may not be able to successfully develop NB-01 pursuant to other alternatives, including as an orphan drug.

 

NB-01 has successfully completed two Phase 2 proof-of-concept clinical trials for PDN. However, in light of the present business environment including the impact of the COVID-19 disease that emerged in December 2019 as a global pandemic, we have determined that any attempt to conduct Phase 3 clinical trials for NB-01, as previously announced, would be difficult if not impossible in the short or medium term. To conserve financial resources, in the first quarter of 2020 we directed our contract research organization (“CRO”) partners and other vendors working on the Phase 3 clinical trials of NB-01, including Syneos Health, to cease all work and we gave notice of termination of our existing contract arrangements with each of them.

We are currently re-evaluating alternatives to bring the NB-01 asset to the market through a different regulatory pathway. Development of NB-01 as an orphan drug is among the alternatives we are considering, and we may conduct feasibility studies to identify a rare disease relevant to NB-01. There is no assurance that we will be able to pursue this alternative for NB-01.

Our ability to successfully develop NB-01 as an orphan drug would be subject to the following additional risks, among others:

the results from different types of animal models could be inconsistent from the previous data we have;
a limited number of potential participants could make clinical trials for NB-01 difficult; and
disparate locations of a limited number of potential participants could make clinical trials difficult.

 Our business is subject to risks arising from epidemic diseases, such as the COVID-19 pandemic.

 

The outbreak of COVID-19 disease, which has been declared by the World Health Organization to be a pandemic, has spread across the globe and is impacting worldwide economic activity. A pandemic, including COVID-19, or other public health epidemic poses the risk that we or our employees, contractors, suppliers, and other partners may be prevented from conducting business activities for an indefinite period of time, including due to spread of the disease within these groups or due to shutdowns that may be requested or mandated by governmental authorities.

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To date, except for the adjustments to scientific activity described under “Current Scientific Activity” above, the Company has not experienced any significant changes in our business that would have a significant negative impact on our consolidated statements of operations or cash flows.

The continued spread of COVID-19 and the measures taken by the governments of countries affected could disrupt the supply chain and the manufacture or shipment of both drug substance and finished drug product for our product candidates for preclinical testing and clinical trials and adversely impact our business, financial condition or results of operations. We often attend and present updates at various medical and investor conferences throughout the year. The COVID-19 pandemic has caused, and is likely to continue to cause, cancellations or reduced attendance of these conferences and we may need to seek alternate methods to present clinical updates and to engage with the medical and investment communities. The spread of COVID-19 may also slow potential enrollment of clinical trials and reduce the number of eligible patients for our clinical trials. The COVID-19 pandemic and mitigation measures may also have an adverse impact on global economic conditions which could have an adverse effect on our business and financial condition and our potential to conduct financings on terms acceptable to us, if at all. The extent to which the COVID-19 pandemic impacts our results will depend on future developments that are highly uncertain and cannot be predicted, including new information that may emerge concerning the severity of the virus and the actions to contain its impact.

ITEM 2.UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

Not applicable.

ITEM 3.DEFAULTS UPON SENIOR SECURITIES

Not applicable.

ITEM 4.MINE SAFETY DISCLOSURES

Not applicable.

ITEM 5.OTHER INFORMATION

On June 7, 2020, we entered into a manufacturing and supply agreement (the “Manufacturing and Supply Agreement”) with Dong-A ST for the manufacturing and supply of NB-02 drug product and placebo for the purpose of research and development of NB-02, including but not limited to, the use in the first NB-02 human clinical trial to be conducted by us. Under the terms of the Manufacturing and Supply Agreement, upon receipt of a purchase order from us no later than 270 days prior to the requested delivery date, Dong-A ST has agreed to produce for us tablets of the NB-02 drug substance and placebos at a specified supply price. We are obligated to manufacture, or have manufactured, and supply to Dong-A the active pharmaceutical ingredients which are necessary to manufacture the NB-02 drug product. The Manufacturing and Supply Agreement has a five year term, subject to earlier termination under certain circumstances.

This disclosure is provided in lieu of disclosure in Item 1.01 of Form 8-K, in accordance with SEC rules.

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ITEM 6.              EXHIBITS

EXHIBIT
NUMBER

    

DESCRIPTION OF DOCUMENT

4.1

Form of Placement Agent’s Warrant (incorporated by reference to Exhibit 4.1 to the Company's Current Report on Form 8-K, filed on April 15, 2020).

10.1

Form of Securities Purchase Agreement (incorporated by reference to Exhibit 10.1 to the Company's Current Report on Form 8-K, filed on April 15, 2020).

10.2

Dong-A ST CO., LTD. Manufacturing and Supply Agreement (NB-02 formerly DA-9803) dated June 7, 2020.

31.1

Certification of Principal Executive Officer and Principal Financial Officer Pursuant to Exchange Act Rule 13a-14(a) or 15d-14(a), as Adopted Pursuant to Section 302 of The Sarbanes Oxley Act of 2002.

32.1

Certification of Principal Executive Officer and Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

101.INS

XBRL Instance Document

101.SCH

XBRL Taxonomy Extension Schema Document

101.CAL

XBRL Taxonomy Extension Calculation Linkbase Document

101.DEF

XBRL Taxonomy Extension Definition Linkbase Document

101.LAB

XBRL Taxonomy Extension Label Linkbase Document

101.PRE

XBRL Taxonomy Extension Presentation Linkbase Document

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

Registrant: NeuroBo Pharmaceuticals, Inc.

SIGNATURE

TITLE

DATE

/s/ RICHARD KANG

President and Chief Executive Officer

August 11, 2020

Richard Kang

(Principal Financial Officer and duly authorized to sign on behalf of the registrant)

41


Exhibit 10.2

[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this exhibit have been omitted by means of marking such portions with asterisks as the identified confidential portions (i) are not material and (ii) would be competitively harmful if publicly disclosed.]

MANUFACTURING AND SUPPLY AGREEMENT

(NB-02 formerly DA-9803)

Between

DONG-A ST CO., LTD.

And

NEUROBO PHARMACEUTICALS, INC.

Dated: June 07, 2020


[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this exhibit have been omitted by means of marking such portions with asterisks as the identified confidential portions (i) are not material and (ii) would be competitively harmful if publicly disclosed.]

MANUFACTURING AND SUPPLY AGREEMENT

(NB-02)

This MANUFACTURING AND SUPPLY AGREEMENT (this "Agreement ' ) is made and entered into as of June 07, 2020 ("Effective Date') by and between:

Dong-A ST Co., Ltd., a corporation duly incorporated under the laws of the Republic of Korea, having its principal place of business at 64 Cheonho-daero, Dongdaemun-gu , Seoul 02587, Republic of Korea ("Dong-A') and

NeuroBo Pharmaceuticals , Inc., a corporation duly incorporated  under the laws of the State of Dela ware, having its principal place of business at 200 Berkeley St. FL 19 , Boston, MA 02116 ,

U.S.A. ("NeuroBo").

RECITALS

WHEREAS, NeuroBo desires that Dong-A manufacture and supply NeuroBo with NB-02 drug product and its matching placebo, for the purpose of research and development of NB-02, including but not limited to, the use in the first human clinical trial to be conducted by NeuroBo ("Purpose");

WHEREAS, NeuroBo desires that Dong-A supply to NeuroBo the NB-02 drug product and its matching placebo to be manufactured by Dong-A after the Effective Date in compliance with the quality standard required for IND submission and clinical trial of NB-02 in the United States (the "Standard ' ); and

WHEREAS, Dong-A agrees to manufacture and supply exclusively to NeuroBo, NB-02 drug product and its matching placebo in strict compliance with the Standard, and NeuroBo agrees to purchase from Dong-A , NB-02 drug product and/or its matching placebo for the Purpose, on the terms and conditions hereinafter set forth.

Now, THEREFORE, in consideration of the foregoing premises and the mutual covenants contained herein and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, Dong-A and NeuroBo mutually agree as follows:

1.

DEFINITIONS

The capitalized terms utilized herein shall have the meanings as defined in this Agreement as follows:

1.1

" Affiliate" means , with respect to a Person, with respect to a Person, a legal entity that, directly or indirectly, through one or more intermediaries, controls, is controlled by, or is under common control with that Person. For purposes of this definition only, " control" and, with correlative meanings, the terms "controlled by" and "under common control with" means (a) the possession, directly or indirectly, of the power to direct the management or policies of a legal entity, whether through the ownership of voting securities or by contract relating to voting rights or corporate governance , or (b) the ownership, directly or


[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this exhibit have been omitted by means of marking such portions with asterisks as the identified confidential portions (i) are not material and (ii) would be competitively harmful if publicly disclosed.]

indirectly, of more than fifty percent (50%) of the voting securities or other ownership interest of a legal entity; provided, however, that if local law restricts foreign ownership, control will be established by direct or indirect ownership of the maximum ownership percentage that may, under such local law, be owned by foreign interests.

1.2

" Confidential Information " means (a) any information , data, or know-how (in whatever form or format) that is (i) related to a Party 's business or technology including , but not limited to, that which relates to or which embodies research, product plans, products, services, customers, markets , software, developments , inventions (whether or not patentable) , processes, designs , drawings, mask works , integrated circuit topographies , engineering, hardware configuration information , infrastructure, price schedules , software design and configuration, processes , marketing or finances of such Party, and (ii) identified in writing as confidential by such Party or, if orally or visually dis closed, identified as confidential at the time of disclosure as confidential and confirmed in writing as confidential within thirty (30) days thereafter.

1.3

" Governmental Authority" means any federal, state, loc al, foreign, or other governmental , quasi-governmental or administrative body, instrumentality, department or agency or any court, tribunal, administrative hearing body, arbitration panel, commission, or other similar dispute-resolving panel or body.

1.4

" Laws" means any statute, rule , regulation , ordinance, code, directive, writ, injunction, settlement , permit, license, decree , judgment , or order of a Governmental Authority.

1.5

" Party" means each of Dong-A and NeuroBo, collectivel y " Parties."

1.6

" Person" means any individual, partnership, joint venture, corporation , trust, unincorporated organization, limited liability company, group, governmental authority, and any other person or entity.

1.7

"Third Party" means any Person other than NeuroBo and Dong-A.

2.

MANUFACTURE AND SUPPLY

2.1Subject to the provisions hereof , Dong-A shall manufacture in compliance with the Standard and in conformity with the specifications separately agreed upon between the Parties and attached hereto as Exhibit A (the "Product Specifications" ) as may be amended by the Parties' agreement in writing from time to time , and supply to NeuroBo the NB-02 dug product and/or its matching placebo, and NeuroBo shall purchase from Dong-A the NB-02 drug product and /or its matching placebo for the Purpose.

2.2NeuroBo shall manufacture, or have manufactured, and supply to Dong-A the active pharmaceutical ingredients (API), which are necessary to manufacture the NB-02 drug

2


[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this exhibit have been omitted by means of marking such portions with asterisks as the identified confidential portions (i) are not material and (ii) would be competitively harmful if publicly disclosed.]

product, in the quantity and in conformity with the specifications separately agreed upon between the Parties and attached hereto as Exhibit C (the"AP/ Specifications") as may be amended by the Parties ' agreement in writing from time to time .

2.3NeuroBo shall, at its costs and expenses, deliver the API to the place designated by Dong-A no later than [***] days prior to the requested delivery date for the NB-02 and/or its matching placebo in accordance with the Firm Order.

2.4Within [***] days after receipt of the API from NeuroBo , Dong-A shall perform a quality control test agreed upon between the Parties (the "AP/ Test" ) in accordance with the methods of the API Test on such API for acceptance (the "AP/ Test Methods" ), which shall be separately agreed in writing by and between the Parties and attached hereto as "Exhibit D" as may be amended by the Parties' agreement in writing from time to time . Dong-A shall conduct no other tests of the API without NeuroBo's written approval. NeuroBo shall provide Dong-A with all available information and technical assistance necessary for Dong-A to perform the API Test expeditiously. If the API is deficient in quantity or the API Test indicates that the API does not meet the API Specifications, Dong-A shall notify NeuroBo thereof in writing within the [***] -day period together with results of the API Test. If the quantity is deficient, NeuroBo shall, as soon as commercially reasonable , s hip, or have shipped , the sufficient amount of additional API to cover the deficiency. If the API does not meet the API Specifications, NeuroBo shall retrieve the API at its own expense and replace the API at no additional cost to Dong-A.

2.5Upon [***] days ' notice and at time mutually agreed upon by the Parties during Dong-A's normal business hours , but no more frequently than [***] every year during the term of this Agreement , NeuroBo may, at its cost and expense , inspect Dong-A's manufacturing facilities where the NB-02 are manufactured. Within [***] days after the completion of the inspection , NeuroBo shall provide a written report detailing the results of such audit to Dong-A. In case of any inspection by any Governmental Authority of Dong-A' s manufacturing facilities where the NB-02 are manufactured, NeuroBo shall promptly provide Dong-A with a notice of the inspection and all notice s, correspondence and related documents received from or sent to the applicable Governmental Authority. Dong-A shall permit such Governmental Authority to inspect the facilities to the fullest extent permitted by Laws and shall make its commercially reasonable efforts and cooperate with the Governmental Authority in conducting the inspection . NeuroBo shall provide such assistance as reasonably requested by Dong-A for the preparation of and during such inspection and furnish Dong-A with copies of all reports and notices received as a result of any such inspection. NeuroBo agrees that Dong-A shall not be obligated to correct any deficiencies documented by the Governmental Authority as a result of any such inspection. NeuroBo further agrees that it shall not hold Dong-A responsible nor shall bring any claims or actions against Dong­ A for any such deficiencies and/or costs or damages NeuroBo may incur resulting therefrom. Upon request of Dong-A, the Parties may discuss in good faith a plan for NeuroBo to assist in correcting such deficiencies and the terms and conditions for implementing the corrective actions under such plan.

2.6The Parties acknowledge and agree that prior to commercialization of the NB-02 by NeuroBo, its Affiliates and/or sublicensees, the Parties shall, in good faith , negotiate the terms and conditions for, including, without limitation, the supply price, and enter into a definitive non­ exclusive supply agreement pursuant to which Dong-A shall supply to NeuroBo the NB-02 for the commercialization by NeuroBo, its Affiliates and/or sublicensees of the NB-02.

3


[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this exhibit have been omitted by means of marking such portions with asterisks as the identified confidential portions (i) are not material and (ii) would be competitively harmful if publicly disclosed.]

2.7In case NeuroBo requests Dong-A to conduct any additional activities, including any testing (e.g. , AMY, PV), documentation (e.g. , CMC packaging) or manufacturing process development, which NeuroBo requires for obtaining the NOA or manufacturing of NB-02 drug product, the Parties shall, in good  faith, negotiate  the terms and  conditions, including, without limitation , the costs and expenses for conducting such additional activities , all of which shall be documented in a separate agreement.

3.

ORDERING AND DELIVERY

3.1NeuroBo shall submit to Dong-A an order for the NB-02 drug product and/or its matching placebo no later than [***] days prior to the requested delivery date thereof. For each order, NeuroBo shall be obligated to order the NB-02 drug product and/or its matching placebo in whole multiples of the batch , e.g., [***] tablets for Placebo, [***]  tablets for [***]  mg tablet, [***] tablets for [***]  mg tablet. NeuroBo acknowledges and agrees that certain quantity of the NB-02 drug product and/or its matching placebo from each batch ordered shall be retained by Dong-A for use in the stability tests and as retention samples , the summary of which shall be as set forth in Exhibit E, and details of which shall be set forth in a separate stability testing protocol, and NeuroBo shall order the NB-02 drug product and/or its matching placebo in consideration of such quantity to be retained by Dong-A. Each order shall specify at least (i) the quantity of the NB-02 drug product and/or its matching placebo, (ii) the specifications of the NB-02 drug product and/or its matching placebo , including the specifics of packaging, (iii) the expected delivery date for the API , (iv) the requested delivery date for the NB-02 drug product and/or its matching placebo, (v) the shipment terms for the NB-02 drug product and/or its matching placebo and (vi) the supply price for the NB-02 drug product and/or its matching placebo . Upon receipt of the order from Neu roBo, Dong­ A shall promptly acknowledge the receipt of such order. No order shall be binding upon the Parties until accepted in writing by Dong-A and NeuroBo; provided, however, that such acceptance shall not be unreasonably withheld or delayed. Upon acceptance of the order, the order shall be deemed to be a "Firm Order" which shall be binding and may only be revised by agreement of the Parties in writing. Dong-A shall deliver NB-02 drug product and/or its matching placebo to NeuroBo in accordance with the Firm Order on the shipment terms of EXW manufacturing facility of Dong-A (ICC Incoterms 20 I 0), including the delivery date and place set forth therein , within the later of (i) [***]  days after the date of the Firm Order or (ii) [***] days after the date of acceptance by Dong-A of the APL

3.2Dong-A shall supply NeuroBo with the NB-02 drug product and/or its matching placebo together with a certificate of analysis, as described in the Product Specifications , for each batch of the NB-02 drug product and/or its matching placebo shipped hereunder certifying that such batch of the NB-02 drug product and/or its matching placebo meets the Product Specifications.

3.3Within [***] days after receipt of the NB-02 drug product and/or its matching placebo hereunder , NeuroBo may, in its discretion , perform a quality control test (the "Product Test') in accordance with the methods of the test on such NB-02 drug product and/or its matching placebo for acceptance (the "Product Test Methods" ), which shall be separately agreed·in writing by and between Dong-A and NeuroBo and attached hereto as Exhibit B, as may be amended by

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[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this exhibit have been omitted by means of marking such portions with asterisks as the identified confidential portions (i) are not material and (ii) would be competitively harmful if publicly disclosed.]

the Parties' agreement in writing from time to time. Dong-A shall provide NeuroBo with all available information and technical assistance necessary for NeuroBo to perform the Product Test expeditiously. If the NB-02 drug product and/or its matching placebo is deficient in quantity or the Product Test indicates that the NB-02 drug product and/or its matching placebo does not meet the Product Specifications , NeuroBo shall notify Dong-A thereof in writing within the [***]­ day period together with results of the Product Test. If the quantity is deficient , Dong-A shall immediately ship the sufficient amount of additional NB-02 drug product and/or its matching placebo to cover the deficiency. If Dong-A does not agree that the NB-02 drug product and/or its matching placebo fails to meet the Product Specifications , the Parties shall refer their disagreement for decision by an independent testing laboratory agreed by the Parties . The decision by the independent testing laboratory shall be conclusive and binding on both Partie s, and the losing Party shall bear the costs of the independent testing laboratory. If Dong-A agrees that the NB-02 drug product and/or its matching placebo does not meet the Product Specifications, or if the decision by the testing laboratory confirms that the NB-02 drug product and/or its matching placebo does not meet the Product Specifications , (i) Dong-A shall arrange for the return from NeuroBo of the NB-02 drug product and/or its matching placebo at Dong-A's expense, and (ii) without waiting for the return, Dong-A shall promptly replace the entire order of NB-02 drug product and/or its matching placebo at no additional cost to NeuroBo

4.

TERMS AND CONDITIONS OF SALE

4.1The terms and conditions of sale and purchase of the NB-02 drug product and/or its matching placebo between Dong-A and NeuroBo shall be set forth in each Firm Order.

4.2The supply prices for the NB-02 drug product and its matching placebo shall be specified in Schedule 4.2.

4.3Upon agreement by the Parties of the Finn Order, Dong-A shall issue to NeuroBo an invoice in Korean Won for each shipment of the NB-02 drug product and/or its matching placebo based on the Firm Order. Unless otherwise agreed in writing by Dong-A, NeuroBo shall pay the invoiced supply price (i) in Korean Won (KRW) or (ii) in United States Dollars (USO) which amount shall correspond with the invoiced amount converted from KRW to USO at the exchange rate of the payment date, no later than [***] days prior to the shipment date by way of wire transfer to Dong-A. NeuroBo shall be responsible for and pay all wire transfer fees incurred. If Dong-A does not receive payment of any sum due to it on or before the due date , simple interest shall thereafter accrue on the sum due to until the date of payment at the [***] rate of [***]  percent over the then-current prime rate quoted by Citibank in New York, New York or the maximum rate allowable by New York law, whichever is lower.

4.4Dong-A shall not be responsible for any taxes levied on account of the payment s made by Neurobo under this Agreement. In the event that any taxes are required to be paid on account of any payment hereunder , NeuroBo shall pay all such taxes.

4.5In performing its obligations under this Agreement , each party shall, and shall cause its Affiliates and sublicensees to, comply with all applicable laws, including any applicable anti­ corruption or anti-bribery laws or regulation, of any Governmental Authority with jurisdiction over the activities performed by a party or its Affiliates or sublicensees in furtherance of such obligations.

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[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this exhibit have been omitted by means of marking such portions with asterisks as the identified confidential portions (i) are not material and (ii) would be competitively harmful if publicly disclosed.]

5.

LIMITATION OF LIABILITY

5.1EXCEPT FOR A BREACH OF SECTION 7 OR INDEMNIFICATION OF THIRD PARTY CLAIMS UNDER SECTION 6, IN NO EVENT WILL ANY PARTY BE LIABLE FOR ANY CONSEQUENTIAL, INDIRECT, EXEMPLARY , SPECIAL, PUNITIVE, OR INCIDENTAL DAMAGES , OR FOR ANY LOST DATA OR CONFIDENTIAL INFORMATION, LOST PROFITS OR COSTS OF PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES, OR BUSINESS INTERRUPTION ARISING FROM OR RELATING TO THIS AGREEMENT, HOWEVER CAUSED AND UNDER ANY THEORY OF LIABILITY (INCLUDING NEGLIGENCE), EVEN IF THE PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES . NOTWITHSTANDING THIS SECTION 5.1, A PARTY DOES NOT EXCLUDE OR LIMIT LIABILITY IN RESPECT OF PERSONAL INJURY OR DEATH TO THE EXTENT SUCH LIABILITY CANNOT BE EXCLUDED OR LIMITED UNDER APPLICABLE LAW.

5.2EXCEPT FOR THIRD PARTY CLAIMS UNDER SECTION 6, EACH PARTY ' S TOTAL CUMULATIVE LIABILITY IN CONNECTION WITH THIS AGREEMENT WHETHER IN CONTRACT OR TORT OR OTHERWISE , SHALL NOT EXCEED TWO MILLION UNITED STATES DOLLARS (USD $2,000,000.00). THE EXISTENCE OF ONE OR MORE CLAIMS SHALL NOT ENLARGE THIS LIMIT.

5.3EACH PARTY ACKNOWLEDGES THAT THE LIMITATIONS OF SECTION 5 REFLECT THE ALLOCATION OF RISK SET FORTH IN THIS AGREEMENT AND THAT NEITHER PARTY WOULD ENTER INTO THIS AGREEMENT WITHOUT THESE LIMITATIONS ON ITS RESPECTIVE LIABILITY , AND EACH PARTY AGREES THAT THESE LIMITATIONS WILL APPLY NOTWITHSTANDING ANY FAILURE OF ESSENTIAL PURPOSE OF ANY LIMITED REMEDY.

6.

INDEMNIFICATION

6.1Indemnification of NeuroBo. Subject to Section 5, NeuroBo, its Affiliates, and each of their respective directors, officers, trustees, shareholders , employees , and agents (collectively , "NeuroBo lndemnitees") will be indemnified, defended by counsel reasonably acceptable to NeuroBo, and held harmless by Dong-A from and against any loss or damage of any kind or nature which are incurred by virtue of or result from any breach of the covenants or other obligations of Dong-A under this Agreement, except to the extent that any claims have arisen from the gross negligence or willful misconduct of any NeuroBo lndemnitee or the breach of an obligation under this Agreement by any NeuroBo Indemnitee.

6.2Indemnification of Dong-A. Subject to Section 5, Dong-A, its Affiliates, and each of their respective directors , officers, trustees , shareholders , employees, and agents (collectively , "Dong-A lndemnitees") will be indemnified, defended by counsel reasonably acceptable to Dong-A, and held harmless by NeuroBo from and against any loss or damage of any kind or nature which are incurred by virtue of or result from NeuroBo's use of NB-02 drug product and its matching placebo in clinical trial, except to the extent that any claims have arisen from the gross negligence or willful misconduct of any Dong-A Indemnitee or the breach of an obligation under this Agreement by any Dong-A Indemnitee.

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[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this exhibit have been omitted by means of marking such portions with asterisks as the identified confidential portions (i) are not material and (ii) would be competitively harmful if publicly disclosed.]

6.3

Defense of Claims

(a)In the case of any claim for indemnification under Section 6.I (if NeuroBo) or Section 6.2 (if Dong-A) arising from a claim of a Third Party, an indemnified party must give prompt notice and, subject to the following sentence, in no case later than twenty (20) days after the indemnified party ' s receipt of notice of such claim, to the indemnifying party of any claim of which such indemnified party has knowledge and as to which it may request indemnification hereunder . The failure to give such notice will not, however , relieve the indemnifying party of its indemnification obligations except to the extent that the indemnifying party is actually harmed thereby.

(b)The indemnifying party will have the right to defend and to direct the defense against any such claim in its name and at its expense, and with counsel selected by the indemnifying party unless (i) the indemnifying party acknowledges fully its obligations to the indemnified party(ies) under this Agreement within fifteen (15) days after receiving notice of such Third Party claim; (ii) the applicable Third Party claim alleges fraud; (iii) there is a conflict of interest between the indemnified party and the indemnifying party in the conduct of such defense; (iv) the Third Party claim is criminal in nature , could reasonably be expected to lead to criminal proceedings, or seeks an injunction or other equitable relief against the indemnified party; (v) the Third Party claim seeks injunctive relief or other equitable remedies against the indemnified party(ies); and/or (vi) the indemnified party is NeuroBo and the Third Party is a customer of NeuroBo.

(c)If the indemnifying party elects, and is entitled, to compromise or defend such claim , it will within twenty (20) days of receipt of notice (or sooner, if the nature of the claim so requires) notify the indemnified party of its intent to do so, and the indemnified party must, at the request and expense of the indemnifying party, cooperate in the defense of such claim.

(d)If the indemnifying party elects not to compromise or defend such claim , fails to notify the indemnified party of its election as herein provided or refuses to acknowledge or contests its obligation to indemnify under this Agreement, the indemnified party may pay, compromise or defend such claim .

(e)Except as set forth in the immediately preceding subsection , the indemnifying party will have no indemnification obligations with respect to any such claim which will be settled by the indemnified party without the prior written consent of the indemnifying party (which consent may not be unreasonably withheld or delayed ); provided, however, that notwithstanding the foregoing, the indemnified party will not be required to refrain from paying any claim that has matured by an order, unless an appeal is duly taken therefrom and exercise thereof has been stayed , nor will it be required to refrain from paying any claim where the del_ay in paying such claim would result in the foreclosure of a lien upon any of the property or assets then held by the indemnified party or where any delay in payment would cause the indemnified party material economic loss.

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[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this exhibit have been omitted by means of marking such portions with asterisks as the identified confidential portions (i) are not material and (ii) would be competitively harmful if publicly disclosed.]

(f)The indemnifying party ' s right to direct the defense will include the right to compromise or enter into an agreement settling any claim by a Third Party; provided that no such compromise or settlement will obligate the indemnified party to agree to any settlement that requires the taking or restriction of any action (including the payment of money and competition restrictions) by the indemnified party other than the delivery of a release, except with the prior written consent of the indemnified party (such consent to be withheld or delayed only for a good faith reason).

(g)Notwithstanding the indemnifying party ' s right to compromise or settle in accordance with the immediately preceding sentence, the indemnifying party may not settle or compromise any claim over the objection of the indemnified party; provided, however , that consent by the indemnified party to settlement or compromise will not be unreasonably withheld or delayed.

(h)The indemnified party will have the right to participate in the defense of any claim with counsel selected by it subject to the indemnifying party's right to direct the defense. The fees and disbursements of such counsel will be at the expense of the indemnified party; provided , however , that, in the case of any claim which seeks injunctive or other equitable relief against the indemnified party, the fees and disbursements of such counsel will be at the expense of the indemnifying party.

6.4Non-Third Party Claims. Any claim which does not result from a Third Party claim will be asserted by a notice to the other Party and will be identified as a " DIRECT INDEMNITY CLAIM NOTICE. " The recipient of such notice will have a period of thirty (30) days after receipt of such notice within which to respond thereto. During such thirty (30)-day period , the recipient will have the right to cure any applicable breach of this Agreement. If the recipient does not respond within such thirty (30) days and does not cure the applicable breach , the recipient will be deemed to have accepted responsibility for the Losses set forth in such notice and will have no further right to contest the validity of such notice . If the recipient responds within such thirty (30) days after the receipt of the notice and rejects such claim in whole or in part, the Party delivering will be free to pursue such remedies as may be available to it under contract or applicable law.

7.

CONFIDENTIALITY

7.1Duty to Hold in Confidence. For a period of five (5) years after the Effective Date, each Party ("Receiving Party") shall preserve in strict confidence and secure against unauthorized use or disclosure any Confidential Information obtained from or with respect to the other Party ("Disclosing Party"). In preserving the Disclosing Party ' s Confidential Information , Receiving Party shall use the same standard of care it would use to secure and safeguard its own confidential information of similar importance , but in no event less than reasonable care. Any permitted reproduction of the Disclosing Party ' s Confidential Information shall contain all confidential or proprietary legends that appear on the original. Receiving Party shall immediate ly notify the Disclosing Party in writing in the event of any loss or unauthorized disclosure or use of Confidential Information known by the Receiving Party. Receiving Party shall use the Disclosing Party ' s Confidential Information disclosed hereunder solely for the purpose of fulfilling such Party ' s obligations and exercising such Party ' s rights under this Agreement.

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[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this exhibit have been omitted by means of marking such portions with asterisks as the identified confidential portions (i) are not material and (ii) would be competitively harmful if publicly disclosed.]

7.2Exclusions. The foregoing obligations shall not apply to information which: (a) was publicly known and available in the public domain prior to the time of disclosure to the Receiving Party by the Disclosing Party; (b) becomes publicly known and available in the public domain after disclosure to the Receiving Party by the Disclosing Party through no action or inaction of the Receiving Party; (c) is lawfully in the possession of the Receiving Party at the time of disclosure by the Disclosing Party as evidenced by the written records of the Receiving Party; (d) is independently developed by the Receiving Party without use of or reference to the Disclosing Party' s Confidential Information as evidenced by the written records of the Receiving Party; (e) is received by the Receiving Party from a Third Party which the Receiving Party has no reason to believe has a duty of confidentiality to the Disclosing Party; or (t) has been approved for disclosure by the Disclosing Party in writing.

7.3Permitted Disclosures. Receiving Party shall permit access to the Disclosing Party ' s Confidential Information solely to its directors , officer, employees, representatives , agents, and contractors who: (a) have a need to know such information for purposes of performing the Disclosing Party' s obligations or exercising the Disclosing Party' s rights hereunder ; and (b) have signed confidentiality agreements containing terms at least as restrictive as those contained herein or have a professional obligation to maintain the confidentiality thereof. Except as permitted in the exercise of the licenses and rights granted under this Agreement , Receiving Party shall not disclose or transfer any Confidential Information to any Third Party, without the specific prior written approval of the Disclosing Party, except to the extent required by law or governmental or court order to be disclosed by Receiving Party, provided that Receiving Party gives the Disclosing Party prompt notice of such requirement (if permitted by law) prior to such disclosure and cooperates with the Disclosing Party in the latter' s attempt, if any, to prevent such disclosure or in obtaining a protective or similar order with respect to the Confidential Information to be disclose d.

7.4Return of lnformation. The Disclosing Party retains ownership of all Confidential Information disclosed or made available to Receiving Party. Upon any termination, cancellation, or expiration of this Agreement, or upon the Disclosing Party's request for any reason (other than in breach of this Agreement) , Receiving Party shall return promptly to the Disclosing Party (or destroy at the Disclosing Party' s request with a signed certification thereof) the originals and all copies (without retention of any copy) of any written documents , tools, materials , or other tangible items containing or embodying Confidential Information; provide d, however , that Receiving Party shall be entitled to retain such originals and copies of Confidential Information of the Disclosing Party (which may be in electronic form) solely for archival purposes, defense of claims , and as are necessary to Receiving Party ' s use and exploitation, as permitted by this Agreement, of any rights retained by Receiving Party following such termination, cancellation, expiration or request.

7.5Remedies. Receiving Party agrees that its obligations provided in this Section 7 are necessary and reasonable in order to protect the Disclosing Party and its business, and expressly agrees that monetary damages would be inadequate to compensate the Disclosing Party for any breach by the Receiving Party of its covenants and agreements set forth in this Agreement. Accordingly, each Party agrees and acknowledges that any such breach or threatened breach may allow the Receiving Party or Third Parties to unfairly compete with the Disclosing Party resulting in irreparable injury to the Disclosing Party and that, in addition to any other remedy that may be

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[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this exhibit have been omitted by means of marking such portions with asterisks as the identified confidential portions (i) are not material and (ii) would be competitively harmful if publicly disclosed.]

available , in law, in equity or otherwise , the Disclosing Party shall be entitled to seek and obtain (without being required to post a bond or other security) injunctive relief against the threatened breach of this Agreement or the continuation of any such breach by the Receiving Party, without the necessity of proving actual damages.

7.6Publicity. Except as necessary to comply with any applicable laws or regulations , each Party agrees not to issue any press release or public statement disclosing the terms of this Agreement without the prior written consent of the other Party, not to be unreasonably withheld, conditioned or delayed. Prior to being released or made , a copy of all press releases and public statements which a Party intends to issue or make regarding the terms of this Agreement , shall be provided to the other Party for approval.

8.

TERM AND TERMINATION

8.1This Agreement  shall  commence  on  the  Effective  Date  and,  unless  earlier terminated, shall continue in full force and effect for a period of five (5) years thereafter.

8.2A Patty may terminate this Agreement by notice to the other Party if the other Party is in material breach of any provision of this Agreement, and

(a)the breaching Party has not cured the breach within sixty (60) days after receiving notice from the terminating Party; or

(b)if the breach cannot reasonably be cured within the sixty (60) day period, the breaching Party has not started to remedy the breach within the sixty (60) day period and diligently endeavored to cure the breach within a reasonable time thereafter.

8.3Either Party may terminate this Agreement immediately upon notice to the other Party in the event that (a) the other Party is the subject of a petition for bankruptcy , reorganization , or arrangement, whether voluntary or involuntary, and the same is not dismissed within thirty (30) days thereof, (b) a receiver or trustee is appointed for all or a substantial portion of the assets of the other Party, or (c) the other Party makes an assignment for the benefit of its creditors .

8.4The termination or expiration of this Agreement , in whole or  in  part,  shall  be without prejudice to the right of either Dong-A and NeuroBo to receive all payments accrued and unpaid at the effective date of such termination or expiration, without prejudice to the remedy of either Dong-A and NeuroBo in respect to any previous breach of any of the representations , warranties, covenants or obligations herein contained and without prejudice to any other provisions hereof which expressly or necessarily call for performance after such termination or expiration.

9.

GOVERNING LAW

The laws of the State of New York (without giving effect to its conflicts of law principles) govern all matters arising out of or relating to this Agreement and all of the transactions it contemplates , including without limitation, its validity, interpretation, construction, performance, and enforcement.

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[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this exhibit have been omitted by means of marking such portions with asterisks as the identified confidential portions (i) are not material and (ii) would be competitively harmful if publicly disclosed.]

10.

SUBMISSION TO JURISDICTION/WAIVER OF JURY TRIAL

EACH OF THE PARTIES AND THEIR RESPECTIVE OFFICERS, DIRECTORS, AND EMPLOYEES HEREBY IRREVOCABLY AND UNCONDITIONALLY: (I) SUBMITS FOR ITSELF AND ITS PROPERTY IN ANY LEGAL ACTION OR PROCEEDING RELATING TO THIS AGREEMENT OR FOR RECOGNITION AND ENFORCEMENT OF ANY JUDGMENT IN RESPECT THEREOF, TO THE NON-EXCLUSIVE GENERAL JURISDICTION OF THE COURTS OF NEW YORK, THE COURTS OF THE UNITED STATES OF AMERICA FOR NEW YORK, AND APPELLATE COURTS FROM ANY THEREOF; (II) CONSENTS TO THE FULLEST EXTENT PERMITTED BYLAW THAT ANY SUCH ACTION OR PROCEEDING MAY BE BROUGHT IN SUCH COURTS AND HEREBY VOLUNTARILY AND IRREVOCABLY WAIVES TRIAL BY JURY AND IN ANY ACTION OR OTHER PROCEEDING BROUGHT IN CONNECTION WITH THIS AGREEMENT ANY OBJECTION THAT IT MAY NOW OR HEREAFTER HAVE TO THE VENUE OF ANY SUCH ACTION OR PROCEEDING IN ANY SUCH COURT OR THAT SUCH ACTION OR PROCEEDING WAS BROUGHT IN AN INCONVENIENT COURT AND AGREES NOT TO PLEAD OR CLAIM THE SAME, AND (III) AGREES TO THE FULLEST EXTENT BY LAW THAT SERVICE OF PROCESS IN ANY SUCH ACTION OR PROCEEDING MAY BE EFFECTED BY MAILING A COPY THEREOF BY REGISTERED OR CERTIFIED MAIL, POSTAGE PREPAID, TO THE PARTY AT ITS ADDRESS SET FORTH IN THE OPENING PARAGRAPH OF THIS AGREEMENT AND HEREBY  ACCEPTS SERVICE OF PROCESS IF MADE IN ACCORDANCE WITH THIS SECTION 10.

11.

NOTICES

All not ices, consents, and approvals under this Agreement must be delivered in writing by courier, electronic mail (with confirmation of deli very), or certified or registered mail , (postage prepaid and return receipt requested) to the other Party; and shall be effective upon receipt or three (3) business days after being deposited in the mail, whichever occurs sooner. Notices to the Parties shall be sent to the addresses set forth at the beginning of this Agreement. Notice of change of address shall be given in the same manner as other communications.

12.

GENERAL PROVISIONS

12.1Force Majeure. No Party shall be liable for any failure to perform its obligations under this Agreement if prevented from doing so by a cause or  causes  beyond  its  reasonable control and not the fault of the nonperforming Party,  and  the  nonperforming  Party  has  been unable to avoid or overcome the act or event by the exercise of due diligence,  including,  by  way of example and without limitation , war, flood , fire, earthquake, riots, strikes, acts of God or public enemy , restraints of government , terrorist acts, and military action .

12.2Assignment. Neither Party may assign or transfer any of its rights under this Agreement , voluntarily, in voluntarily , or by operation of law, or in any other manner , without the prior written consent of the other Party; provided , however , that either Party may assign its rights under this Agreement in connection with a merger , consolidation, or sale of substantially all of its assets with prior written notice to the other Party and if the successor entity agrees in writing to be bound by all of the terms and conditions of this Agreement. Any purported assignment or transfer of rights in violation of this section is null and void. Subject to the foregoing, this Agreement shall bind and inure to the benefit of the Parties and their respective successors and permitted assigns.

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[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this exhibit have been omitted by means of marking such portions with asterisks as the identified confidential portions (i) are not material and (ii) would be competitively harmful if publicly disclosed.]

12.3Waivers. Any waiver or failure to enforce any provision of this Agreement on one occasion shall not be deemed a waiver of any other provision or of such provision on any other occasion.

12.4Severability. If any provision of this Agreement is held by a court of competent jurisdiction to be unenforceable, such provision shall be changed and interpreted to accomplish the objectives of such provision to the greatest extent possible under applicable law and the remaining provisions of this Agreement shall continue in full force and effect.

12.5Remedies. The Parties' rights and remedies under this Agreement are cumulative. It is understood and agreed that notwithstanding any other provisions of this Agreement , a breach by a Party under this Agreement shall cause the other Parties irreparable damage for which recovery of money damages would be inadequate , and that, in addition to any and all remedies available at law, the other Parties shall be entitled to seek timely injunctive relief to protect their rights under this Agreement. If any legal action is brought to enforce this Agreement, the prevailing Party shall be entitled to receive its reasonable attorneys' fees, court costs, and other collection expenses, in addition to any other relief it may receive.

12.6Independent Contractor/No  Agency.  Each  Party agrees and acknowledges  that in its performance of its obligations under this Agreement , it is an independent contractor of the other Parties and is solely responsible for its own activities. No Party shall have any authority to make commitments or enter into contracts on behalf  of,  bind,  or  otherwise  obligate  the  other Party in any manner whatsoever. Nothing contained herein shall be construed as creating  any agency, partnership , or other form of joint enterprise between the Parties.

12.7Entire Agreement. This Agreement constitutes the entire agreement between the Parties regarding the subject hereof and supersedes all prior or contemporaneous agreements, under standings, and communication, whether written or oral.

<Signature page follows.>

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[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this exhibit have been omitted by means of marking such portions with asterisks as the identified confidential portions (i) are not material and (ii) would be competitively harmful if publicly disclosed.]

IN WITNESS WHEREOF, the Parties hereto have duly executed this Agreement as of the Effective Date.

DONG-A ST CO., LTD.

By:

/s/ Daesik Eom

Daesik Eom, Chairman and CEO

NEUROBO PHARMACEUTICALS, INC.

By:

/s/ Richard Kang

Richard Kang, Chairman and CEO

13


Exhibit 31.1

CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER AND PRINCIPAL FINANCIAL OFFICER

PURSUANT TO EXCHANGE ACT RULE 13a-14(a) OR 15d-14(a), AS ADOPTED PURSUANT TO

SECTION 302 OF THE SARBANES OXLEY ACT OF 2002

I, Richard Kang, certify that:

1. I have reviewed this quarterly report on Form 10-Q of NeuroBo Pharmaceuticals, Inc. for the quarterly period ended June 30, 2020;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations, and cash flows of the registrant as of, and for, the periods presented in this report;

4. I am responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s Board of Directors (or persons performing the equivalent functions):

(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: August 11, 2020

/s/ RICHARD KANG

Name:

Richard Kang

Title:

President and Chief Executive Officer

(Principal Executive Officer and Principal Financial Officer)


Exhibit 32.1

CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER AND PRINCIPAL FINANCIAL OFFICER,

PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE

SARBANES-OXLEY ACT OF 2002*

Pursuant to the requirement set forth in Rule 13a-14(b) or Rule 15d-14(b) of the Securities and Exchange Act of 1934, as amended (the “Exchange Act”), and Section 1350 of Chapter 63 of Title 18 of the United States Code, Richard Kang, President and Chief Executive Officer of NeuroBo Pharmaceuticals, Inc. (the “Company”) hereby certifies that, to the best of his knowledge:

1. The Company’s Quarterly Report on Form 10-Q for the period ended June 30, 2020, to which this Certification is attached as Exhibit 32.1 (the “Quarterly Report”) fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act, and

2. The information contained in the Quarterly Report fairly presents, in all material respects, the financial condition of the Company at the end of the period covered by the Quarterly Report and results of operations of the Company for the period covered by the Quarterly Report.

/s/ RICHARD KANG

President and Chief Executive Officer

(Principal Executive Officer and Principal Financial Officer)

Dated: August 11, 2020


*     This certification accompanies the report to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of NeuroBo Pharmaceuticals, Inc. under the Securities Act of 1933, as amended, or the Exchange Act made before or after the date of the report, irrespective of any general incorporation language contained in such filing.


v3.20.2
Document and Entity Information - shares
6 Months Ended
Jun. 30, 2020
Aug. 11, 2020
Cover [Abstract]    
Document Type 10-Q  
Document Period End Date Jun. 30, 2020  
Entity Registrant Name NeuroBo Pharmaceuticals, Inc.  
Entity Current Reporting Status Yes  
Entity Interactive Data Current Yes  
Entity Filer Category Non-accelerated Filer  
Entity Small Business true  
Entity Emerging Growth Company true  
Entity Ex Transition Period true  
Entity Shell Company false  
Entity Common Stock, Shares Outstanding   16,427,307
Entity Central Index Key 0001638287  
Current Fiscal Year End Date --12-31  
Document Fiscal Year Focus 2020  
Document Fiscal Period Focus Q2  
Amendment Flag false  
v3.20.2
Condensed Consolidated Balance Sheets - USD ($)
$ in Thousands
Jun. 30, 2020
Dec. 31, 2019
Current assets:    
Cash $ 14,298 $ 13,908
Restricted cash   15
Prepaid expenses 908 153
Other assets 37 42
Total current assets 15,243 14,118
Right-of-use assets 105 116
Property and equipment, net 172 200
Other assets 32 34
Total assets 15,552 14,468
Current liabilities:    
Accounts payable 1,683 638
Accrued liabilities 1,426 1,422
Lease liability, short-term 23 22
Total current liabilities 3,132 2,082
Lease and other long-term liabilities 82 94
Total liabilities 3,214 2,176
Commitments and contingencies (Note 5)
Stockholders’ equity:    
Preferred stock, $0.001 par value; 10,000,000 shares authorized; no shares issued or outstanding as of June 30, 2020 and December 31, 2019.
Common stock, $0.001 par value per share, 100,000,000 shares authorized; 16,427,307 and 15,592,718 shares issued and outstanding as of June 30, 2020 and December 31, 2019, respectively. 17 16
Additional paid–in capital 56,317 49,130
Accumulated other comprehensive (loss) income (16) 12
Accumulated deficit (43,980) (36,866)
Total stockholders’ equity 12,338 12,292
Total liabilities and stockholders’ equity $ 15,552 $ 14,468
v3.20.2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares
Jun. 30, 2020
Dec. 31, 2019
Condensed Consolidated Balance Sheets    
Preferred stock, par value (in dollar per share) $ 0.001 $ 0.001
Preferred stock, shares authorized 10,000,000 10,000,000
Preferred stock, shares issued 0 0
Preferred stock, shares outstanding 0 0
Common stock, par value (in dollar per share) $ 0.001 $ 0.001
Common stock, shares authorized 100,000,000 100,000,000
Common stock, shares issued 16,427,307 15,592,718
Common stock, shares outstanding 16,427,307 15,592,718
v3.20.2
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($)
$ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2020
Jun. 30, 2019
Jun. 30, 2020
Jun. 30, 2019
Operating expenses:        
Research and development $ 674 $ 948 $ 2,826 $ 2,748
General and administrative 1,718 939 4,315 1,590
Total operating expenses 2,392 1,887 7,141 4,338
Loss from operations (2,392) (1,887) (7,141) (4,338)
Interest income (expense), net 8 (14) 28 (27)
Other expense, net     (1)  
Loss before income taxes (2,384) (1,901) (7,114) (4,365)
Provision for income taxes 0 0 0 0
Net loss (2,384) (1,901) (7,114) (4,365)
Other comprehensive loss:        
Foreign currency translation loss, net of tax 6 11 (28) 9
Total other comprehensive loss 6 11 (28) 9
Comprehensive loss $ (2,378) $ (1,890) $ (7,142) $ (4,356)
Loss per share:        
Net loss per share, basic and diluted (Note 11) $ (0.15) $ (0.37) $ (0.44) $ (0.84)
Weighted average common shares outstanding:        
Basic and diluted 16,303,681 5,166,812 15,987,240 5,166,812
v3.20.2
Condensed Consolidated Statements of Changes in Stockholders’ Equity (Deficit) - USD ($)
Redeemable Convertible Preferred Stock
Common Stock
Additional Paid-in Capital
Accumulated Other Comprehensive (loss) Income
Accumulated Deficit
Total
Balance at beginning of period at Dec. 31, 2018 $ 16,746,000   $ 2,266,000 $ 2,000 $ (15,554,000) $ (13,286,000)
Balance at beginning of period (shares) at Dec. 31, 2018 4,801,020 5,166,812        
Increase (Decrease) in Stockholders' Equity            
Stock–based compensation     60,000     60,000
Foreign currency translation adjustment       (2,000)   (2,000)
Net loss         (2,464,000) (2,464,000)
Balance at end of period at Mar. 31, 2019 $ 16,746,000   2,326,000   (18,018,000) (15,692,000)
Balance at end of period (shares) at Mar. 31, 2019 4,801,020 5,166,812        
Balance at beginning of period at Dec. 31, 2018 $ 16,746,000   2,266,000 2,000 (15,554,000) (13,286,000)
Balance at beginning of period (shares) at Dec. 31, 2018 4,801,020 5,166,812        
Increase (Decrease) in Stockholders' Equity            
Net loss           (4,365,000)
Balance at end of period at Jun. 30, 2019 $ 40,921,000 $ 5,166,812 2,405,000 11,000 (19,919,000) (17,503,000)
Balance at end of period (shares) at Jun. 30, 2019 8,264,613          
Balance at beginning of period at Mar. 31, 2019 $ 16,746,000   2,326,000   (18,018,000) (15,692,000)
Balance at beginning of period (shares) at Mar. 31, 2019 4,801,020 5,166,812        
Increase (Decrease) in Stockholders' Equity            
Issuance of common stock in exchange for process research and development $ 24,175,000          
Issuance of common stock in exchange for process research and development (in shares) 3,463,593          
Stock–based compensation     79,000     79,000
Foreign currency translation adjustment       11,000   11,000
Net loss         (1,901,000) (1,901,000)
Balance at end of period at Jun. 30, 2019 $ 40,921,000 $ 5,166,812 2,405,000 11,000 (19,919,000) (17,503,000)
Balance at end of period (shares) at Jun. 30, 2019 8,264,613          
Balance at beginning of period at Dec. 31, 2019   $ 16,000 49,130,000 12,000 (36,866,000) 12,292,000
Balance at beginning of period (shares) at Dec. 31, 2019   15,592,718        
Increase (Decrease) in Stockholders' Equity            
Exercise of stock options     53,000     53,000
Exercise of stock options (in shares)   84,589        
Stock–based compensation     159,000     159,000
Foreign currency translation adjustment       (34,000)   (34,000)
Net loss         (4,730,000) (4,730,000)
Balance at end of period at Mar. 31, 2020   $ 16,000 49,342,000 (22,000) (41,596,000) 7,740,000
Balance at end of period (shares) at Mar. 31, 2020   15,677,307        
Balance at beginning of period at Dec. 31, 2019   $ 16,000 49,130,000 12,000 (36,866,000) $ 12,292,000
Balance at beginning of period (shares) at Dec. 31, 2019   15,592,718        
Increase (Decrease) in Stockholders' Equity            
Exercise of stock options (in shares)           84,589
Net loss           $ (7,114,000)
Balance at end of period at Jun. 30, 2020   $ 17,000 56,317,000 (16,000) (43,980,000) 12,338,000
Balance at end of period (shares) at Jun. 30, 2020   16,427,307        
Balance at beginning of period at Mar. 31, 2020   $ 16,000 49,342,000 (22,000) (41,596,000) 7,740,000
Balance at beginning of period (shares) at Mar. 31, 2020   15,677,307        
Increase (Decrease) in Stockholders' Equity            
Issuance of common stock in connection with equity financing   $ 1,000 7,499,000     7,500,000
Issuance of common stock in connection with equity financing (in shares)   750,000        
Transaction costs in connection with equity financing     (984,000)     (984,000)
Stock–based compensation     171,000     171,000
Issuance of broker warrants in connection with equity financing     289,000     289,000
Foreign currency translation adjustment       6,000   6,000
Net loss         (2,384,000) (2,384,000)
Balance at end of period at Jun. 30, 2020   $ 17,000 $ 56,317,000 $ (16,000) $ (43,980,000) $ 12,338,000
Balance at end of period (shares) at Jun. 30, 2020   16,427,307        
v3.20.2
Condensed Consolidated Statements of Changes in Stockholders’ Equity (Deficit) (Parenthetical) - USD ($)
$ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2019
Jun. 30, 2020
Jun. 30, 2019
Condensed Consolidated Statements of Changes in Stockholders’ Equity      
Payments of Stock Issuance Costs $ 65 $ 695 $ 65
v3.20.2
Condensed Consolidated Statements of Cash Flows - USD ($)
shares in Thousands, $ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2019
Jun. 30, 2020
Jun. 30, 2019
Operating activities      
Net loss $ (1,901) $ (7,114) $ (4,365)
Adjustments to reconcile net loss to net cash used in operating activities:      
Stock-based compensation   330 139
Non cash interest related to convertible notes - related party     29
Depreciation 1 23 1
Lease liability principal payment   (10)  
Non-cash lease expense   10  
Change in assets and liabilities, net of the effects of the reverse asset acquisition:      
Prepaid expenses and other assets   (751) 899
Accounts payable   1,045 599
Accrued and other liabilities   5 282
Net cash used in operating activities   (6,462) (2,416)
Investing activities      
Purchases of property and equipment   (2) (25)
Net cash used in investing activities   (2) (25)
Financing activities      
Proceeds from issuance of common stock and redeemable convertible preferred stock   7,500 24,240
Exercise of stock options   53  
Issuance costs (65) (695) (65)
Net cash provided by financing activities   6,858 24,175
Net increase in cash and restricted cash   394 21,734
Net foreign exchange difference   (19) 9
Cash and restricted cash at beginning of period   13,923 2,845
Cash and restricted cash at end of period $ 24,588 $ 14,298 $ 24,588
Supplemental non-cash financing transactions:      
Placement warrants issued in connection with equity financing   289  
v3.20.2
The Company and Basis of Presentation
6 Months Ended
Jun. 30, 2020
The Company and Basis of Presentation  
The Company and Basis of Presentation

1. The Company and Basis of Presentation

 

NeuroBo Pharmaceuticals, Inc. (together with its subsidiaries, the "Company" or "NeuroBo"), formerly known as Gemphire Therapeutics Inc. (“Gemphire”), is a clinical-stage biotechnology company with three therapeutics programs designed to impact a range of indications in neurodegenerative and cardiometabolic disease:

·

NB-01, which is primarily focused on the development of a treatment for painful diabetic neuropathy, but which the Company believes could also treat a range of neuropathic conditions, including chemotherapy-induced peripheral neuropathy and post-traumatic peripheral neuropathy;

·

NB-02, which has the potential to treat the symptoms of cognitive impairment and modify the progression of neurodegenerative diseases associated with the malfunction of a protein called tau, and with amyloid beta plaque deposition; and

·

Gemcabene, which is focused on developing and commercializing therapies for the treatment of dyslipidemia, a serious medical condition that increases the risk of life-threatening cardiovascular disease, focused on orphan indications such as homozygous familial hypercholesterolemia, as well as nonalcoholic fatty liver disease/nonalcoholic steatohepatitis.

The Company was originally incorporated as Gemphire Therapeutics Inc. In connection with the closing of the Merger (as defined below), the Company changed its name to NeuroBo Pharmaceuticals, Inc. The Company’s operations have consisted principally of performing research and development activities, clinical development and raising capital. The Company's activities are subject to significant risks and uncertainties, including failing to secure additional funding before sustainable revenues and profit from operations are achieved.

 

COVID-19

The Company is subject to risks and uncertainties as a result of the COVID-19 pandemic. The extent of the impact of the COVID-19 pandemic on the Company’s business is highly uncertain and difficult to predict, as the responses that the Company, other businesses and governments are taking continue to evolve. Furthermore, capital markets and economies worldwide have also been negatively impacted by the COVID-19 pandemic, and it is possible that it could cause a lasting national and/or global economic recession. Policymakers around the globe have responded with fiscal policy actions to support the healthcare industry and economy as a whole. The magnitude and overall effectiveness of these actions remain uncertain.

 

To date, except for the adjustments to scientific activity described under “Current Scientific Activity” below, the Company has not experienced any significant changes in our business that would have a significant negative impact on our consolidated statements of operations or cash flows.

 

The severity of the impact of the COVID-19 pandemic on the Company’s business will depend on a number of factors, including, but not limited to, the duration and severity of the pandemic and the extent and severity of the impact on the Company’s service providers, suppliers, contract research organizations and the Company’s clinical trials, all of which are uncertain and cannot be predicted. As of the date of issuance of Company’s financial statements, the extent to which the COVID-19 pandemic may in the future materially impact the Company’s financial condition, liquidity or results of operations is uncertain.

 

Current Scientific Activity

In light of the present business environment, including the impact of the COVID-19 virus that emerged in December 2019 and became a global pandemic, the Company is currently conducting the scientific activities described below with a view toward conserving financial resources.

 

For NB-01, the Company has determined that any attempt to conduct Phase 3 clinical trials, as previously announced, would be difficult if not impossible in the short or medium term. Accordingly, in the first quarter of 2020, the Company directed its contract research organization (“CRO”) partners and other vendors working on the Phase 3 clinical trials of NB-01 to cease all work and has terminated its existing contract arrangements with each of them.

 

The Company is currently devoting scientific resources to evaluating the potential to bring the NB-01 asset to the market through a different regulatory pathway. Development of NB-01 as an orphan drug is among the alternatives that the Company is considering, and the Company may conduct feasibility studies to identify a rare disease relevant to NB-01. There is no assurance that the Company will be able to pursue any orphan drug indication for NB-01.The Company  considered marketing NB-01 as a nutraceutical (non-pharmaceutical) product, but has determined not to pursue such pathway at this time.

The Company is preparing an Investigational New Drug (“IND”) application to the U.S. Food and Drug Administration (“FDA”) for NB-02. The Company intends to postpone the first human clinical trials for NB-02 until global health and macroeconomic conditions improve, with a view toward commencing clinical trial activity in the first half of 2021, subject to improvement of the constraints imposed by the COVID-19 pandemic. The Company is also considering engaging with a strategic partner to assist with clinical trials for NB-02.

In May 2020, the Company received written communication from the U.S. Food and Drug Administration (“FDA”) that the clinical development program for Gemcabene remains on a partial clinical hold. The Company is reviewing its options regarding Gemcabene.

Merger

 

On July 24, 2019, Gemphire Therapeutics Inc. (“Gemphire”), and NeuroBo Pharmaceuticals, Inc. (“Private NeuroBo”) entered into a definitive agreement, which was amended on October 29, 2019 (the “Merger Agreement”). The merger closed on December 30, 2019 (the “Effective Date”), whereby Private NeuroBo merged with a wholly-owned subsidiary of the Company in an all-stock transaction (the “Merger”). 

Upon completion of the Merger, the Company changed its name to NeuroBo Pharmaceuticals, Inc., Private NeuroBo changed its name to NeuroBo Therapeutics, Inc., and the Company changed its ticker symbol on the Nasdaq Capital Market from “GEMP” to "NRBO". Except as otherwise indicated, references herein to “NeuroBo,” “the Company,” the “combined company,” “we,” “us,” and “our,” refer to NeuroBo Pharmaceuticals, Inc. on a post-Merger basis. 

 

Pursuant to the terms of the Merger Agreement, each outstanding share of Private NeuroBo common stock outstanding immediately prior to the closing of the Merger was converted into 1.1431 shares of the Company’s common stock (the “Exchange Ratio”). Immediately prior to the closing of the Merger, all shares of Private NeuroBo redeemable preferred stock then outstanding were exchanged into shares of common stock of Private NeuroBo. In addition, all outstanding options exercisable for common stock of Private NeuroBo converted into options exercisable for shares of the Company’s common stock upon the Merger. Such options and their related terms were adjusted by the Exchange Ratio. Immediately following the Merger, the stockholders of Private NeuroBo owned approximately 96.2% of the outstanding common stock of the Company.

 

The transaction was accounted for as a reverse asset acquisition in accordance with accounting principles generally accepted in the United States of America (“GAAP”). Under this method of accounting, Private NeuroBo was deemed to be the accounting acquirer for financial reporting purposes. This determination was primarily based on the facts that, immediately following the Merger: (i) Private NeuroBo’s stockholders owned substantially all of the voting rights in the combined company, (ii) Private NeuroBo designated all, but one, of the members of the initial board of directors of the combined company, and (iii) Private NeuroBo’s senior management holds all key positions in the senior management of the combined company. As a result, as of the closing date of the Merger, the net assets of Gemphire were recorded at their acquisition-date relative fair values in the consolidated financial statements of the Company and the reported operating results prior to the Merger are those of Private NeuroBo.

 

Basis of presentation and consolidation principles

 

The accompanying condensed consolidated financial statements have been prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”). Certain information and footnote disclosures normally included in annual financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. The condensed consolidated financial statements may not include all disclosures required by GAAP; however, the Company believes that the disclosures are adequate to make the information presented not misleading. These unaudited condensed financial statements should be read in conjunction with the audited financial statements and the notes thereto for the fiscal year ended December 31, 2019 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 30, 2020. The condensed consolidated balance sheet at December 31, 2019 was derived from the audited financial statements.

 

In the opinion of management, all adjustments, consisting of only normal recurring adjustments that are necessary to present fairly the financial position, results of operations, and cash flows for the interim periods, have been made. The results of operations for the interim periods are not necessarily indicative of the operating results for the full fiscal year or any future periods.

 

On August 11, 2019, Private NeuroBo’s board of directors and stockholders approved an amendment to the restated certificate of incorporation to affect a ten thousand-for-one (10,000-for-1) stock split of Private NeuroBo's common stock and convertible preferred stock. The par value and the authorized shares of the common and convertible preferred stock and the exercise prices of options to purchase common stock were adjusted accordingly as a result of the stock split. All issued and outstanding common stock, options for common stock, convertible preferred stock and convertible notes, as well as the exercise price of each option for common stock and the conversion price for convertible preferred stock and convertible notes, have been retroactively adjusted to reflect this stock split for all periods presented.

 

All of the share and per share amounts presented were adjusted, on a retroactive basis, to reflect the ten thousand-for-one (10,000-for-1) stock split and the effect of the exchange of the shares of Private NeuroBo into the shares of the Company at the Exchange Ratio, except for par value and share authorizations of Private NeuroBo for periods presented prior to the Merger.

 

The condensed consolidated financial statements of the Company include a South Korean subsidiary, NeuroBo Co., LTD., which is fully owned by the Company. All significant intercompany accounts and transactions have been eliminated in the preparation of the financial statements.

 

Reclassification of Prior Year Amounts

 

Interest income reported during the comparable prior year periods was reclassified from the other (expense) income, net line item to the interest income (expense), net line item to conform to current year classifications.

 

Going Concern

 

From its inception through June 30, 2020, the Company has devoted substantially all of its efforts to drug discovery and development and conducting clinical trials. The Company has a limited operating history and the sales and income potential of the Company's business and market are unproven. Successful transition to attaining profitable operations is dependent upon achieving a level of revenues adequate to support the Company's cost structure. As of June 30, 2020, the Company had $14.3 million in cash. The Company has experienced net losses and negative cash flows from operating activities since its inception and had an accumulated deficit of $44.0 million as of June 30, 2020.

 

To date, the Company has raised capital principally through the issuance of common stock, convertible notes and private placements of redeemable convertible preferred stock. The Company has raised a total of $16.8 million from the issuance by Private NeuroBo of Series A redeemable convertible preferred stock and $0.5 million from the issuance by Private NeuroBo of convertible notes through December 31, 2018, and $24.2 million from the issuance by Private NeuroBo of Series B redeemable convertible preferred stock in May and June 2019. On April 13, 2020, the Company entered into a Securities Purchase Agreement, pursuant to which the Company agreed to issue and sell, in a registered direct offering (the “Registered Offering”), 750,000 shares of common stock at an offering price of $10 per share. The Registered Offering resulted in gross proceeds of $7.5 million. The Company will need to continue to raise a substantial amount of funds until it is able to generate revenues to fund its development activities.

 

The determination as to whether the Company can continue as a going concern contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Company expects to continue to incur net losses and negative cash flows from operations into the foreseeable future. Successful transition to attaining profitable operations is dependent upon achieving a level of revenues adequate to support the Company's cost structure. The Company has incurred net losses since inception and has relied on its ability to fund its operations through debt and equity financings. These conditions raise substantial doubt about the Company's ability to continue as a going concern. The accompanying condensed consolidated financial statements have been prepared assuming that the Company will continue as a going concern and do not include any adjustments that might result from the outcome of this uncertainty. This basis of accounting contemplates the recovery of the Company's assets and the satisfaction of liabilities in the normal course of business.

 

The Company believes that its existing cash will be sufficient to fund its operations into the second quarter of 2021 at the level of scientific activity described above under “Current Scientific Activity. The Company plans to continue to fund its operations and capital funding needs through a combination of equity offerings, debt financings, or other sources, potentially including collaborations, licenses and other similar arrangements. There can be no assurance that the Company will be able to obtain any sources of financing on acceptable terms, or at all. To the extent that the Company can raise additional funds by issuing equity securities, the Company's stockholders may experience significant dilution. Any debt financing, if available, may involve restrictive covenants that impact the Company's ability to conduct its business.

 

v3.20.2
Summary of Significant Accounting Policies
6 Months Ended
Jun. 30, 2020
Summary of Significant Accounting Policies  
Summary of Significant Accounting Policies

 

2. Summary of Significant Accounting Policies 

 

Use of estimates

 

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, expenses, and related disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of expenses during the reporting period. The most significant estimates in Company's consolidated financial statements relate to accrued expenses and the fair value of stock-based compensation and warrant issuances. The Company bases its estimates on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgements about the carrying values of assets and liabilities. Actual results could differ from those estimates. Changes in estimates are reflected in reported results in the period in which they become known.

 

Concentration of Credit Risk

 

Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash. The Company’s cash is principally held by one financial institution in the United States. Amounts on deposit may at times exceed federally insured limits. Management believes that the financial institution is financially sound, and accordingly, minimal credit risk exists with respect to the financial institution. As of June 30, 2020, the Company had deposits in excess of federally insured amounts by $13.7 million.

 

Fair Value of Financial Instruments

 

The Company’s financial instruments include principally cash, prepaid, other current assets, right of use assets, accounts payable, accrued liabilities, lease liabilities, convertible debt and preferred stock. The carrying amounts of prepaid expenses, accounts payable, and accrued liabilities are reasonable estimates of their fair value because of the short maturity of these items.

 

General and Administrative Expenses

 

General and administrative expenses consist primarily of personnel‑related costs, including salaries and stock-based compensation costs, for personnel in functions not directly associated with research and development activities. Other significant costs include legal fees related to intellectual property and corporate matters and professional fees for accounting and other services.

 

Research and Development Costs

 

Research and development costs are charged to expense as incurred. Research and development expenses are comprised of costs incurred in performing research and development activities, including clinical trial costs, manufacturing costs for both clinical and pre-clinical materials as well as other contracted services, license fees, and other external costs. Nonrefundable advance payments for goods and services that will be used in future research and development activities are expensed when the activity is performed or when the goods have been received, rather than when payment is made, in accordance with Accounting Standards Codification (“ASC”) 730, Research and Development

 

Income Taxes

 

The Company utilizes the liability method of accounting for income taxes as required by ASC 740, Income Taxes. Under this method, deferred tax assets and liabilities are determined based on differences between financial reporting and the tax basis of assets and liabilities and are measured using enacted tax rates and laws that will be in effect when the differences are expected to reverse. Currently, there is no provision for income taxes, as the Company has incurred operating losses to date, and a full valuation allowance has been provided on the net deferred tax assets. 

Stock‑Based Compensation

 

The Company accounts for stock‑based compensation in accordance with the provisions of ASC 718, Compensation — Stock Compensation (“ASC 718”). Accordingly, compensation costs related to equity instruments granted are recognized at the grant‑date fair value. The Company records forfeitures when they occur. Stock-based compensation arrangements to non‑employees are accounted for in accordance with the applicable provisions of ASC 718 using a fair value approach. 

 

Convertible Notes

 

The Company evaluates all conversion and redemption features contained in a debt instrument to determine if there are any embedded features that require bifurcation as a derivative or separation as a beneficial conversion feature. The host debt instrument is discounted for the value of any embedded feature that is accounted for as either a derivative or a beneficial conversion feature. The discount is amortized and recorded to interest expense over the term of the host debt instrument using the effective interest method. The Company’s convertible debt contained an embedded beneficial conversion feature that was separated and recorded as additional paid-in capital.

 

Fair Value of common stock

 

In the absence of a public trading market prior to the Merger, and as a development stage company with no significant revenues, the Company believed that it was appropriate to consider a range of factors to determine the fair value of the common stock at each grant date. In determining the fair value of its common stock, the Company used methodologies, approaches, and assumptions consistent with the American Institute of Certified Public Accountants' (“AICPA”) Audit and Accounting Practice Aid Series: Valuation of Privately Held Company Equity Securities Issued as Compensation (the "AICPA Practice Guide"). The valuations of Private NeuroBo common stock were prepared using a hybrid method, which used market approaches to estimate the enterprise value of Private NeuroBo. The hybrid method is a probability-weighted expected return method ("PWERM"), where the equity value in one or more of the scenarios is calculated using an option pricing method ("OPM"). The PWERM is a scenario-based methodology that estimates the fair value of common stock based upon an analysis of future values for Private NeuroBo, assuming various outcomes. The common stock value was based on the probability-weighted present value of expected future investment returns considering each of the possible outcomes available as well as the rights of each class of stock. The future value of the common stock under each outcome was discounted back to the valuation date at an appropriate risk-adjusted discount rate and probability weighted to arrive at an indication of value for the common stock. A discount for lack of marketability of the common stock was then applied to arrive at an indication of value for the common stock. The OPM treats common stock and preferred stock as call options on the total equity value of a company, with exercise prices based on the value thresholds at which the allocation among the various holders of a company's securities changes. Under this method, the common stock has value only if the funds available for distribution to stockholders exceeded the value of the preferred stock liquidation preferences at the time of the liquidity event, such as a strategic sale or a merger. In addition, the Company considered various objective and subjective factors, along with input from an independent third-party valuation firm. The factors included (1) the achievement of technical and operational milestones by the Company; (2) the status of strategic relationships with collaborators; (3) the significant risks associated with the Company's stage of development; (4) capital market conditions for life science companies and, in particular, similarly situated, privately held, early-stage life science companies; (5) the Company's available cash, financial condition, and results of operations; (6) the most recent sales of the Company's preferred stock to the extent they were with outside parties; and (7) the preferential rights of the outstanding preferred stock.

 

Leases

 

On July 1, 2019, the Company adopted Accounting Standards Update (“ASU”) No. 2016-02, Leases (Topic 842) (“ASU 2016-02”). The Company assesses its contracts at inception to determine whether the contract contains a lease, including evaluation of whether the contract conveys the right to control an explicitly or implicitly identified asset for a period of time. The Company has recognized right-of-use assets and lease liabilities that represent the net present value of future operating lease payments utilizing a discount rate corresponding to the Company’s incremental borrowing rate and amortized over the remaining terms of the leases. For operating leases of a short-term nature, i.e., those with a term of less than twelve months, the Company recognizes lease payments as an expense on a straight-line basis over the remaining lease term. 

 

Property and Equipment

 

Property and equipment is recorded at cost and reduced by accumulated depreciation. Depreciation expense is recognized over the estimated useful lives of the assets using the straight-line method. The estimated useful life for property and equipment ranges from three to five years. Tangible assets acquired for research and development activities and that have an alternative use are capitalized over the useful life of the acquired asset. Estimated useful lives are periodically reviewed, and when appropriate, changes are made prospectively. When certain events or changes in operating conditions occur, asset lives may be adjusted and an impairment assessment may be performed on the recoverability of the carrying amounts. Maintenance and repairs are charged directly to expense as incurred.

 

Foreign Currency Translation

 

The foreign subsidiary uses the local currency as the functional currency. The Company translates the assets and liabilities of its foreign operation into U.S. dollars based on the rates of exchange in effect as of the balance sheet date. Expenses are translated into U.S. dollars using average exchange rates for each period. The resulting adjustments from the translation process are included in accumulated other comprehensive loss in the accompanying condensed consolidated balance sheets.

 

Certain transactions of the Company are settled in foreign currency and are thus translated to U.S. dollars at the rate of exchange in effect at the end of each month. Gains and losses resulting from the translation are included in other income or expense in the accompanying condensed consolidated statements of operations and comprehensive loss.

 

Patent Costs

 

Costs related to filing and pursuing patent applications are expensed as incurred, as recoverability of such expenditures is uncertain. These costs are included in general and administrative expenses.

 

Comprehensive Loss

 

Comprehensive loss is comprised of net loss and other comprehensive income or loss. Comprehensive loss includes net loss as well as other changes in stockholders' equity (deficit) that result from transactions and economic events other than those with stockholders. Comprehensive loss currently consists of net loss and changes in foreign currency translation adjustments.

 

Segment Information

 

Operating segments are components of an enterprise for which separate financial information is available and is evaluated regularly by the Company’s chief operating decision maker in deciding how to allocate resources and assessing performance. The Company’s chief operating decision maker is its Chief Executive Officer. The Company’s Chief Executive Officer views the Company’s operations and manages its business in one operating segment, which is principally the business of development and commercialization of therapeutics.

 

Recent Accounting Pronouncements Adopted

 

From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board ("FASB") or other standard setting bodies that are adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on its consolidated financial position or results of operations upon adoption.

 

In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement (ASU 2018-13). The new guidance modifies the disclosure requirements in Topic 820 as follows:

 

·

Removals: the amount of and reasons for transfers between Level 1 and Level 2 of the fair value hierarchy; the policy for timing of transfers between levels; and the valuation processes for Level 3 fair value measurements.

·

Modifications: for investments in certain entities that calculate net asset value, an entity is required to disclose the timing of liquidation of an investee’s assets and the date when restrictions from redemption might lapse only if the investee has communicated the timing to the entity or announced the timing publicly; and the amendments clarify that the measurement uncertainty disclosure is to communicate information about the uncertainty in measurement as of the reporting date.

·

Additions: the changes in unrealized gains and losses for the period included in other comprehensive income for recurring Level 3 fair value measurements held at the end of the reporting period; and the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements.

This guidance is effective for all entities for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019. The amendments on changes in unrealized gains and losses, the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements, and the narrative description of measurement uncertainty should all be applied prospectively for only the most recent interim or annual period presented in the initial year of adoption. All other amendments should be applied retrospectively to all periods presented upon their effective date. Early adoption is permitted. The Company adopted the new guidance on January 1, 2020. The guidance did not have a material impact on the consolidated financial statements.

 

Recent Accounting Pronouncements Not Yet Adopted

 

In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740) which amends the existing guidance relating to the accounting for income taxes. This ASU is intended to simplify the accounting for income taxes by removing certain exceptions to the general principles of accounting for income taxes and to improve the consistent application of GAAP for other areas of accounting for income taxes by clarifying and amending existing guidance. The ASU is effective for fiscal years beginning after December 15, 2020. The Company does not expect that the adoption of this new guidance will have a material impact on the Company’s consolidated financial statements.

 

v3.20.2
Balance Sheet Detail
6 Months Ended
Jun. 30, 2020
Balance Sheet Detail  
Balance Sheet Detail

3. Balance Sheet Detail (in thousands)

 

Property and Equipment

 

Property and equipment consist of the following:

 

 

 

 

 

 

 

 

 

 

 

 

As of

 

 

 

June 30,

 

 

December 31,

 

 

 

2020

 

 

2019

 

Research and development equipment

 

$

153

 

 

$

158

 

Office equipment

 

 

59

 

 

 

59

 

Total property and equipment

 

 

212

 

 

 

217

 

Less accumulated depreciation

 

 

(40)

 

 

 

(17)

 

Property and equipment, net

 

$

172

 

 

$

200

 

 

 

 

 

 

 

 

 

 

Depreciation expense was $12 and less than $1 for the three months ended June 30, 2020 and 2019, respectively, and $23 and less than $1 for the six months ended June 30, 2020 and 2019, respectively.

 

Accrued liabilities

 

Accrued liabilities consist of the following as of:

 

 

 

 

 

 

 

 

 

 

    

June 30,

 

December 31,

 

 

 

2020

 

2019

 

External research and development expenses

 

$

1,197

 

$

915

 

Professional services

 

 

167

 

 

158

 

Payroll related

 

 

27

 

 

160

 

Other

 

 

35

 

 

189

 

Total

 

$

1,426

 

$

1,422

 

 

 

 

 

 

 

 

 

In the first quarter of 2020, the Company directed its contract research organization (“CRO”) partners and other vendors working on the Phase 3 clinical trials of NB-01 to cease all work and has terminated its existing contract arrangements with each of them. The Company incurred termination expenses of approximately $675  in connection with these terminations which are included in the external research and development expenses line item in the above table.  One CRO invoiced termination charges that the Company disputes. In accordance with ASC 450, Contingencies, the Company has determined that it is reasonably possible that a loss has occurred with respect to these invoiced amounts and estimates the range of loss as $0 to $1,100. Since no amount in this range is a better estimate than any other amount within the range, the Company has not accrued any liability arising from potential losses relating to these disputed termination charges.

 

During the three months ended March 31, 2020, the Company recorded adjustments to research and development expenses related to clinical trial expenses that were not correctly recorded in prior periods. The net adjustments resulted in an increase of $186 in the Company’s net loss for the three months ended March 31, 2020, which the Company considers immaterial to all periods. 

v3.20.2
Merger
6 Months Ended
Jun. 30, 2020
Merger  
Merger

4. Merger

 

The Merger, which closed on December 30, 2019, was accounted for as a reverse asset acquisition pursuant to Topic 805, Business Combinations, as substantially all of the fair value of the assets acquired were concentrated in a group of similar non-financial assets, and the acquired assets did not have outputs or employees.

 

Contingent Value Rights Agreement

 

On December 30, 2019, in connection with the Merger, the Company, Grand Rapids Holders’ Representative, LLC, as representative of the Company’s stockholders prior to the Merger, and Computershare Inc. and Computershare Trust Company, N.A. as the rights agent, entered into a Contingent Value Rights Agreement (the “CVR Agreement”). The Company’s stockholders of record as of immediately prior to the effective date of the Merger received one contingent value right (“CVR”) entitling such holders to receive, in the aggregate, 80% of the Gross Consideration less other Permitted Deductions (each as defined in the CVR Agreement) received during the 15-year period after the closing of the Merger (the “CVR Term”) from the grant, sale or transfer of rights to Gemcabene (other than a grant, sale or transfer of rights involving a sale or disposition of the post-Merger combined company) that is entered into during the 10-year period after the closing of the Merger or pursuant to the Beijing SL Agreement (as defined in Note 6 – License Agreement below), but not including the $2.5 million upfront gross payment pursuant to the Beijing SL Agreement. Under the CVR Agreement, the Company agreed to commit up to $1 million to support the further development of Gemcabene, to be funded following execution of the Beijing SL Agreement and the receipt by the Company of the $2.5 million upfront gross payment payable under the Beijing SL Agreement, which the Company received in October 2019. The CVRs are not transferable, except in certain limited circumstances, will not be certificated or evidenced by any instrument, will not accrue interest and will not be registered with the SEC or listed for trading on any exchange. The CVR Agreement will continue in effect until the later of the end of the CVR Term and the payment of all amounts payable thereunder. Through June 30, 2020, no milestones had been accrued as there were no potential milestones yet considered probable.

v3.20.2
Commitments and Contingencies
6 Months Ended
Jun. 30, 2020
Commitments and Contingencies  
Commitments and Contingencies

5. Commitments and Contingencies (in thousands)

 

Operating Leases

 

Boston Leases

 

In April 2018, the Company entered a non-cancelable operating lease for its headquarters in Boston, MA (the “Boston Lease”). The lease was subsequently amended, and the term was extended to August 2019 with an option to extend the term on a month-to-month basis. The Company exercised the option and extended the lease term on a month-to-month basis through January 15, 2020. The lease is subject to base lease payments and additional charges for common costs related to usage of shared space. Due to its short-term nature, the Company recognizes lease payments as an expense on a straight-line basis over the remaining lease term.

 

In September 2019, the Company entered a non-cancelable operating lease, as amended, for its new corporate headquarters located in Boston, Massachusetts (“New Boston Lease”). The agreement, effective February 1, 2020, has a one-year term, and rental costs of $21 per month prior to the application of certain rent concessions granted by the landlord in the amount of $32.  

 

For the three and six months ended June 30, 2020, expense under the New Boston Lease and Boston Lease in the aggregate was $65 and $180, inclusive of a termination fee of $83,  respectively. For the three and six months ended June 30, 2019, expense under the Boston Lease in the aggregate was $27 and $53, respectively.

 

 

Future minimum lease payments at June 30, 2020 were as follows under the New Boston Lease (in thousands):

 

 

 

 

 

 

 

 

December 31,

 

 

 

 

 

 

2020 (period from July 1 to December 31)

 

$

129

 

2021

 

 

21

 

Total minimum payments

 

$

150

 

 

 

 

 

 

Lease in Korea:

 

In May 2019, the Company entered a non-cancelable operating lease for its new facility in Korea (the “Korea Lease”). The initial lease term is five years with an option to renew for an additional five-year term. The lease commenced on July 2, 2019 and expires on July 1, 2024. The operating lease is subject to a deposit, base rent payments and additional charges for utilities and other common costs. In the third quarter of 2019, the Company recognized a right-of-use asset of $126 as well as a lease liability of $20 in other current liabilities and $106 in other non-current liabilities in conjunction with the commencement of the Korea Lease. The Company’s lease liability represents the net present value of future lease payments utilizing a discount rate of 10%, which corresponds to the Company’s incremental borrowing rate. As of June 30, 2020, the weighted average remaining lease term was 4.00 years. For the three and six month periods ended June 30, 2020, the Company recorded non-cash expense of $8 and $16, respectively, related to the Korea Lease. During the six month period ended June 30, 2020, the Company made cash payments of $16 for amounts included in the measurement of lease liabilities. There was no expense or payment activity related to the Korea Lease during the three and six month periods ended June 30, 2019.

 

The following table reconciles the undiscounted lease liabilities to the total lease liabilities recognized on the consolidated balance sheet as of June 30, 2020 (in thousands):

 

 

 

 

 

 

 

 

 

 

 

December 31,

 

2020 (period from July 1 to December 31)

 

$

16

 

2021

 

 

32

 

2022

 

 

32

 

2023

 

 

32

 

2024

 

 

16

 

Total lease payments

 

 

128

 

Less effect of discounting

 

 

(23)

 

 Total

 

 

105

 

Short-term portion

 

 

(23)

 

Long-term portion

 

$

82

 

 

Xiehecheng Cultivation Service Agreement

 

On September 1, 2018, the Company entered into a cultivation service agreement with Xiehecheng Chinese Herm Limited Corporation for the cultivation of two plants used to manufacture the Company's clinical assets.

 

As of June 30, 2020, future minimum payments under the agreement, which is cancellable annually at the end of each research year, are as follows (in thousands):

 

 

 

 

 

 

 

 

December 31,

 

 

 

 

 

 

2020

(period from July 1 to December 31)

$

66

 

2021

 

 

220

 

2022

 

 

220

 

 

 

$

506

 

 

Pfizer License Agreement

Upon the close of the Merger, the exclusive license agreement with Pfizer Inc. (“Pfizer”) for the clinical product candidate Gemcabene (the “Pfizer Agreement”) was assumed by the Company. Under the Pfizer Agreement, in exchange for this worldwide exclusive right and license to certain patent rights to make, use, sell, offer for sale and import the clinical product Gemcabene, the Company has agreed to certain milestone and royalty payments on future sales.

 

The Company agreed to make milestone payments totaling up to $37 million upon the achievement of certain milestones, including the first new drug application (or its foreign equivalent) in any country, regulatory approval in each of the United States, Europe and Japan, the first anniversary of the first regulatory approval in any country, and upon achieving certain aggregate sales levels of Gemcabene. Future milestone payments under the Pfizer Agreement, if any, are not expected to begin for at least several years and extend over a number of subsequent years.

 

The Company also agreed to pay Pfizer tiered royalties on a country‑by‑country basis based upon the annual amount of net sales, as specified in the Pfizer Agreement, until the later of: (a) five (5) years after the first commercial sale in such country; (b) the expiration of all regulatory or data exclusivity for Gemcabene in such country; and (c) the expiration or abandonment of the last valid claim of the licensed patents, including any patent term extensions or supplemental protection certificates in such country (collectively, the Royalty Term). Under the Pfizer Agreement, the Company is obligated to use commercially reasonable efforts to develop and commercialize Gemcabene.

 

None of the future milestone or royalty payments were triggered through June 30, 2020.

 

The Pfizer Agreement will expire upon expiration of the Royalty Term. On expiration (but not earlier termination), the Company will have a perpetual, exclusive, fully paid-up, royalty-free license under the licensed patent rights and related data to make, use, develop, commercialize, import and otherwise exploit the clinical product candidate Gemcabene. Either party may terminate the Pfizer Agreement for the other party’s material breach following a cure period or immediately upon certain insolvency events relating to the other party. Pfizer may immediately terminate the Pfizer Agreement in the event that (i) the Company or any of its affiliates or sublicenses contests or challenges, or supports or assists any third party to contest or challenge, Pfizer’s ownership of or rights in, or the validity, enforceability or scope of any of the patents licensed under the Pfizer Agreement or (ii) the Company or any of its affiliates or sublicensees fails to achieve the first commercial sale in at least one country by April 16, 2024.

 

Furthermore, upon termination of the Pfizer Agreement by Pfizer for any of the foregoing reasons, the Company grants Pfizer a non-exclusive, fully paid-up, royalty free, worldwide, transferrable, perpetual and irrevocable license to use any intellectual property rights arising from the development or commercialization of Gemcabene by the Company and any trademarks identifying Gemcabene and agrees to transfer regulatory filings and approvals to Pfizer or permit Pfizer to cross-reference and rely on such regulatory filings and approvals for Gemcabene. The Company may terminate the Pfizer Agreement for convenience upon 90 days’ written notice and payment of an early termination fee of $3.0 million.

 

As of June 30, 2020 and December 31, 2019, there was sufficient uncertainty with regard to both the outcome of the clinical trials and the ability to obtain sufficient funding to support any of the cash milestone payments under the license agreement, and as such, no liabilities were recorded related to the Pfizer Agreement.

 

Contingencies

 

From time to time, the Company may be subject to various claims and suits arising in the ordinary course of business. The Company does not expect that the resolution of these matters will have a material adverse effect on its financial position or results of operations.

 

Contract Research Agreements

In the first quarter of 2020, the Company directed its CRO partners and other vendors working on the Phase 3 clinical trials of NB-01 to cease all work and has terminated its existing contract arrangements with each of them. The Company incurred termination expenses of approximately $675 in connection with these terminations. One CRO invoiced termination charges that the Company disputes. In accordance with ASC 450, Contingencies, the Company has determined that it is reasonably possible that a loss has occurred with respect these invoiced amounts and estimates the range of loss as $0 to $1,100. Since no amount in this range is a better estimate than any other amount within the range, the Company has not accrued any liability arising from potential losses relating to these disputed termination charges.

v3.20.2
License Agreement
6 Months Ended
Jun. 30, 2020
License Agreement  
License Agreement

6. License Agreement

Beijing SL License and Collaboration Agreement

 

Upon the close of the Merger, the License and Collaboration Agreement (the “Beijing SL Agreement”) with Beijing SL Pharmaceutical Co., Ltd. (“Beijing SL”) was assumed by the Company, pursuant to which the Company granted Beijing SL an exclusive royalty-bearing license to research, develop, manufacture and commercialize pharmaceutical products comprising, as an active ingredient, Gemcabene in mainland China, Hong Kong, Macau and Taiwan (each, a “region,” and collectively, the “Territory”). The terms of the agreement include payments based upon achievement of milestones and royalties on net product sales. Under the Beijing SL Agreement, the Company has variable consideration in the form of milestone payments. As of June 30, 2020, no revenue under the Beijing SL Agreement has been recognized. 

 

Under the terms of the Beijing SL Agreement, Beijing SL will be responsible, at its expense, for developing and commercializing products containing Gemcabene (each, a “Licensed Product”) in the Territory, with certain assistance from the Company. To the extent mutually agreed to in writing, the Company and Beijing SL will collaborate on the Phase 3 clinical trial for homozygous familial hypercholesterolemia or other clinical trials with the Company as the sponsor designed to enroll patients both inside and outside the Territory (a “Global Study”), but Beijing SL will be responsible, at its expense, for the conduct of any Global Study to the extent solely in the Territory, subject to the Company’s final decision making authority, and the Company will be responsible, at its expense, for the conduct of any Global Study to the extent solely outside of the Territory. Under a territory development plan, the parties shall develop Licensed Products with respect to the Territory. Beijing SL will be responsible for development activities, including non-clinical and clinical studies directed at obtaining regulatory approval of the Licensed Product in the Territory. Beijing SL has agreed to use commercially reasonable efforts to commercialize the Licensed Products for each indication that receives regulatory approval in the Territory and shall prepare and present a commercialization plan that shall be subject to approval by the joint steering committee.

 

Pursuant to the Beijing SL Agreement, Beijing SL was to make a non-refundable upfront gross payment of $2.5 million to the Company within 45 days of the effective date of the Beijing SL Agreement; the upfront payment was received in October 2019 and such funds were fully expended prior to the close of Merger. Additionally, with respect to each Licensed Product, the Company is eligible to receive (i) payments for specified developmental and regulatory milestones (including submission of a new drug application to China’s National Medical Product Administration, dosing of the first patient in a phase 3 clinical trial in mainland China and regulatory approval for the first and each additional indication of a Licensed Product in the Territory) totaling up to $6 million in the aggregate and (ii) payments for specified global net sales milestones of up to $20 million in the aggregate multiplied by the ratio of the net sales of a Licensed Product sold by Beijing SL in the Territory divided by the global net sales of a Licensed Product, which net sales milestone payments are payable once, upon the first achievement of such milestone.

 

Beijing SL is also obligated to pay the Company tiered royalties ranging from the mid-teens to twenty percent on the net sales of all Licensed Products in the Territory until the latest of (a) the date on which any applicable regulatory exclusivity with respect to such Licensed Product expires in such region, (b) the expiration or abandonment of the last valid patent claim or joint patent claim covering such Licensed Product in each region and (c) the fifth anniversary of the first commercial sale of such Licensed Product in such region (the “Royalty Term”). Future milestone payments under the Beijing SL Agreement, if any, are not expected to begin for at least one year and will extend over a number of subsequent years. The Company cannot determine the date on which Beijing SL’s potential royalty payment obligations to the Company would expire because Beijing SL has not yet developed any Licensed Products under the Beijing SL Agreement and therefore the Company cannot at this time identify the date of the first commercial sale or the periods of any regulatory exclusivity or patent claims with respect to any Licensed Product.

 

On a Licensed Product-by-Licensed Product and region-by-region basis upon the expiration of the Royalty Term, the license granted to Beijing SL shall be deemed perpetual, fully paid-up and royalty free with respect to such Licensed Product in such region. Either party may terminate the Agreement (x) with written notice in the event of the other party’s material breach following a cure period or (y) if the other party becomes subject to certain insolvency proceedings. In addition, the Company may terminate the agreement in its entirety if Beijing SL or its affiliates or sublicensees commence a proceeding challenging the validity, enforceability or scope of any of the Company’s patents.

 

To the extent rights granted to Beijing SL under the Beijing SL Agreement are controlled by the Company pursuant to the Pfizer Agreement, such rights are subject to the terms and conditions of such agreement with Pfizer, and Beijing SL has agreed to comply with such terms and conditions.

 

The Beijing SL Agreement contemplates that Beijing SL and the Company shall, no later than twelve months prior to the anticipated date of the first commercial sale of a Licensed Product, if any, negotiate in good faith and execute a commercial supply agreement, pursuant to which Beijing SL shall purchase from the Company, and the Company shall use commercially reasonable efforts to supply, Gemcabene or Licensed Product for clinical or commercial purposes, as applicable, until manufacturing and regulatory transfers are complete.

 

Each of the Company and Beijing SL has agreed to indemnify the other party against certain losses and expenses relating to the development or commercialization of a Licensed Product by the indemnifying party, the negligence or willful misconduct of the indemnifying party or its directors, officers, employees or agents or a breach of the indemnifying party’s representations, warranties or covenants. 

 

v3.20.2
Debt
6 Months Ended
Jun. 30, 2020
Debt  
Debt

7. Debt (in thousands, except share and per share data)

 

In February 2018, the Company received a total of $500 from the issuance by Private NeuroBo of convertible promissory notes (the "Convertible Notes") with an original maturity date of December 31, 2022. On December 30, 2019, the Convertible Notes were converted into 1,565,300 shares of common stock.

 

Prior to conversion, the lenders had the option to convert all of the then-unpaid note balance including principal and accrued but unpaid interest into common stock, at a conversion price of $0.40 per share after the earlier of (A) the closing of a firmly underwritten public offering pursuant to an effective registration statement under the Securities Act of 1933, as amended, covering the offer and sale of common stock for the account of the Company in the United States of America or similar registration in the Republic of Korea, or (B) January 1, 2020. On October 23, 2019, the Convertible Notes were amended (the “Amended Convertible Notes”) to require mandatory conversion upon the completion of a reverse merger transaction based on the then-unpaid note balance including principal and accrued but unpaid interest into common stock, at a conversion price of $0.40 per share.

 

The Convertible Notes and Amended Convertible Notes (herein collectively referred to as the “Notes”) accrued interest at a rate of 5.00% per annum. The Company recorded interest on principal of $7 and $13 for the three and six month periods ended June 30, 2019, respectively. The Notes were not outstanding during 2020.

 

The fair value of the common stock, as determined using an option pricing model consistent with the AICPA Practice Guide, was in excess of the conversion price of the Convertible Notes. Accordingly, the Company initially recorded a $401 beneficial conversion feature upon issuance based on the intrinsic value of the conversion feature, which resulted in a debt discount with a corresponding amount to additional paid in capital.

 

Debt discount related to the beneficial conversion feature was being amortized over the life of the Convertible Notes using the effective interest method as additional interest expense. The Company recorded interest expense of $8 and $16 for the three and six month periods ended June 30, 2019 , respectively, related to the debt discount.

 

v3.20.2
Stockholders’ Equity Deficit
6 Months Ended
Jun. 30, 2020
Stockholders’ Equity  
Stockholders’ Equity

8. Stockholders’ Equity (Deficit)

 

Common Stock

 

The voting, dividend, and liquidation rights of the holders of the common stock are subject to and qualified by the rights, powers, and preferences of the holders of the preferred stock when outstanding. The holders of the common stock are entitled to one vote for each share of common stock held at all meetings of stockholders.

 

Dividend Rights

 

Common stock holders are entitled to receive dividends at the sole discretion of the board of directors of the Company. There have been no dividends declared on common stock as of June 30, 2020.

 

Voting Rights

 

The holders of common stock are entitled to one vote for each share of common stock along with all other classes and series of stock of the Company on all actions to be taken by the stockholders of the Company, including actions that would amend the certificate of incorporation of the Company to increase the number of authorized shares of the common stock.

 

Liquidation Rights

 

In the event of any liquidation, dissolution, or winding‑up of the Company, the holders of common stock shall be entitled to share in the remaining assets of the Company available for distribution post preferential distributions made to holders of the Company’s preferred stock.

 

April 2020 Equity Financing

 

On April 13, 2020, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with an institutional investor, pursuant to which the Company sold, in a registered direct offering (the “Registered Offering”), 750,000 shares (the “Shares”) of the Company’s common stock at an offering price of $10 per share.

 

The Registered Offering resulted in gross proceeds of $7.5 million, before deducting the placement agent’s fees and related offering expenses. The Registered Offering closed on April 16, 2020.

 

In connection with the Registered Offering, the placement agent received a cash commission equal to 7% of the gross proceeds from the sale of the Common Stock and warrants (the “Placement Agent’s Warrants”) to purchase up to 37,500 shares of Common Stock, which represented 5.0% of the Shares sold in the Registered Offering. The Placement Agent’s Warrants have an exercise price of $12.50 per share, which represented 125% of the per share offering price of the Shares and a termination date of April 16, 2025. The fair value of the Placement Agent’s Warrants was $289 and was based on the Black-Scholes pricing model. Input assumptions used were as follows: a risk-free interest rate of 0.4%; expected volatility of 78.0%; expected life of 5 years; and expected dividend yield of 0%. The underlying traded stock price was used in the analysis. The Placement Agent’s Warrants were classified in stockholders’ equity as the number of shares were fixed and determinable and given that the Placement Agent’s Warrants did not require cash settlement or have other provisions precluding equity treatment.

 

During the three and six months ended June 30, 2020, issuance costs in connection with the Registered Offering were $1.0 million which included cash commissions equal to $0.5 million, legal and other fees of $0.2 million and Placement Agent’s Warrants with a value of $0.3 million.    

 

 

Warrants

 

The following warrants were outstanding as of June 30, 2020 and December 31, 2019:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Exercise Price

 

 

Number Outstanding

 

 

Expiration Date

 

Number Exercisable

 

 

 

$

186.75

 

 

 

1,440

 

 

July 2028

 

 

1,440

 

 

 

$

260.00

 

 

 

39,115

 

 

March 2022

 

 

39,115

 

 

Total outstanding December 31, 2019

 

 

40,555

 

 

 

 

 

40,555

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

$

12.50

 

 

 

37,500

 

 

April 2025

 

 

37,500

 

 

Total outstanding June 30, 2020

 

 

78,055

 

 

 

 

 

78,055

 

 

v3.20.2
Stock-Based Compensation
6 Months Ended
Jun. 30, 2020
Stock-Based Compensation  
Stock-Based Compensation

9. Stock-based Compensation 

 

Stock-based compensation expense was included in general and administrative and research and development costs as follows in the accompanying statements of comprehensive loss (in thousands):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

 

Six Months Ended

 

 

June 30, 

 

 

June 30, 

 

 

 

2020

    

 

2019

 

    

 

2020

 

    

2019

 

Research and development

$

4

 

$

16

 

 

$

18

 

$

55

 

General and administrative

 

167

 

 

63

 

 

 

312

 

 

84

 

Total stock-based compensation

$

171

 

$

79

 

 

$

330

 

$

139

 

 

Stock Options

 

2019 and 2018 Stock Plans

 

In December 2018, Private NeuroBo adopted the NeuroBo Pharmaceuticals, Inc. 2018 Stock Plan (the "2018 Plan") and in December 2019 in connection with the Merger, the Company adopted the 2019 Equity Incentive Plan (the “2019 Plan”). 2018 Plan options to purchase Private NeuroBo common stock outstanding as of immediately prior to the Merger were assumed by the Company upon the Merger and became options to purchase the Company’s common stock, as adjusted by the Exchange Ratio. The 2018 Plan and 2019 Plan provide for the grant of stock options, restricted stock and other equity awards of the Company's common stock to employees, officers, consultants, and directors. Options expire within a period of not more than ten years from the date of grant.

 

The following table summarizes the Company’s activity related to its stock options for the six months ended June 30, 2020 and 2019:

 

 

 

 

 

 

 

 

 

Six Months Ended

 

 

 

June 30, 

 

 

 

2020

 

2019

 

Outstanding on January 1

 

633,277

 

 

Granted

 

360,000

 

960,204

 

Exercised

 

(84,589)

 

 

Forfeited/Cancelled

 

 

 

Outstanding on June 30

 

908,688

 

960,204

 

 

During the six month periods ended June 30, 2020 and 2019, 360,000 and 960,204 stock options were granted, respectively, to employees, non-employee directors and non-employee consultants with both service and performance conditions. The options granted with service conditions vest quarterly over a period between one year and fifteen months. The total number of stock options outstanding as of June 30, 2020 and December 31, 2019 was 908,688 and 633,277, respectively.  There were no stock options granted during the three month periods ended June 30, 2020 and 2019.

 

The weighted average fair value per share of options granted during the six month periods ended June 30, 2020 and 2019, was $5.59 and $0.50, respectively.

 

The Company measures the fair value of stock options with service‑based and performance‑based vesting criteria to employees, consultants and directors on the date of grant using the Black‑Scholes option pricing model. The Company does not have history to support a calculation of volatility and expected term. As such, the Company has used a weighted‑average volatility considering the volatilities of several guideline companies.

For purposes of identifying similar entities, the Company considered characteristics such as industry, length of trading history, and stage of life cycle. The assumed dividend yield was based on the Company’s expectation of not paying dividends in the foreseeable future. The average expected life of the options was determined based on the mid‑point between the vesting date and the end of the contractual term according to the “simplified method” as described in Staff Accounting Bulletin 110. The risk‑free interest rate is determined by reference to implied yields available from U.S. Treasury securities with a remaining term equal to the expected life assumed at the date of grant. The Company records forfeitures when they occur.

 

The weighted‑average assumptions used in the Black‑Scholes option‑pricing model are as follows:

 

 

 

 

 

 

 

 

 

 

 

 

Six Months Ended

 

 

 

June 30,

 

    

 

2020

    

2019

 

 

 

 

 

 

 

 

Expected stock price volatility

 

 

77.5

%

 

75.0

%

Expected life of options (years)

 

 

5.8

 

 

10.0

 

Expected dividend yield

 

 

0

%

 

0

%

Risk free interest rate

 

 

1.71

%

 

2.75

%

 

Evergreen provision

 

Under the 2019 Plan, the shares reserved automatically increase on January 1st of each year, for a period of not more than ten years commencing on January 1, 2020 and ending on (and including) January 1, 2029, to an amount equal to the lesser of 4% of the common shares outstanding as of January 1st , or a lesser amount as determined by the Board. The aggregate maximum number of shares of common stock that may be issued pursuant to the 2019 Plan under the evergreen provision is 6,680,000 shares of common stock. On January 1, 2020, 623,708 shares were added to the 2019 Plan as a result of the evergreen provision.

 

During the three month periods ended June 30, 2020 and 2019,  44,289 and 37,150 stock options vested, respectively, and 87,151 and 157,176 stock options vested during the six month periods ended June 30, 2020 and 2019, respectively. During the three and six month periods ended June 30, 2020 and 2019, no stock options were forfeited.

As of June 30, 2020, 4,127,179 shares in the aggregate were available for future issuance under the 2019 Plan and 2018 Plan.

Unrecognized stock‑based compensation cost for the stock options issued under the both the Company’s 2019 Plan and 2018 Plan was $1.7 million as of June 30, 2020. The unrecognized stock‑based expense is expected to be recognized over a weighted average period of 2.5 years.

v3.20.2
Redeemable Preferred Stock
6 Months Ended
Jun. 30, 2020
Redeemable Preferred Stock.  
Redeemable Preferred Stock

10.  Redeemable Preferred Stock (in thousands, except share and per share data)

 

Upon close of the Merger on December 30, 2019, 8,264,613 shares of Private NeuroBo Series A and Series B redeemable preferred stock (as adjusted for the Exchange Ratio) were converted to Private NeuroBo common stock on a 1:1 basis. Previously in April 2018, Private NeuroBo sold and issued in a private placement 4,801,020 shares of Series A redeemable convertible preferred stock (as adjusted for the Exchange Ratio) at $3.50 per share, raising $16,800 in gross proceeds. Subsequently in May and June 2019, Private NeuroBo sold and issued 3,463,593 Series B redeemable convertible preferred stock (as adjusted for the Exchange Ratio) at $7.00 per share, raising $24,240 in gross proceeds. 

 

While outstanding, the redeemable preferred stock was classified outside of stockholders' equity (deficit) because the shares contained certain redemption features that were not solely within the control of the Company. Private NeuroBo did not adjust the carrying values of the convertible preferred stock to the liquidation preferences of such shares because the occurrence of any such change of control event was not deemed probable.

 

v3.20.2
Net Loss Per Common Share
6 Months Ended
Jun. 30, 2020
Net Loss Per Common Share  
Net Loss Per Common Share

11. Net Loss Per Common Share

 

Basic net loss per share is computed by dividing the net loss by the weighted-average number of common shares outstanding for the period, without consideration for potentially dilutive securities if their effect is antidilutive. Diluted net loss per share is computed by dividing the net loss by the weighted average number of shares of common stock and dilutive common stock equivalents outstanding for the period determined using the treasury stock and if-converted methods. Dilutive common stock equivalents are comprised of convertible preferred stock, convertible notes payable, options outstanding under the Company's stock option plan and warrants. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding as inclusion of the potentially dilutive securities would be antidilutive.

 

The following potential common shares were not considered in the computation of diluted net loss per share as their effect would have been anti‑dilutive:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

Six Months Ended

 

 

 

 

 

June 30,

 

June 30,

 

 

 

 

    

2020

    

2019

    

2020

    

2019

 

 

 

Redeemable preferred stock

 

 —

 

8,264,613

 

 —

 

8,264,613

 

 

 

Convertible notes

 

 —

 

1,531,268

 

 —

 

1,531,268

 

 

 

Stock options

 

908,688

 

960,204

 

908,688

 

960,204

 

 

 

Warrants

 

78,055

 

 —

 

78,055

 

 —

 

 

 

 

v3.20.2
Income Taxes
6 Months Ended
Jun. 30, 2020
Income Taxes  
Income Taxes

12. Income Taxes

 

The effective tax rate for the three and six month periods ended June 30, 2020 and 2019 was zero percent. As a result of the analysis of all available evidence as of June 30, 2020 and December 31, 2019, the Company recorded a full valuation allowance on its net deferred tax assets. Consequently, the Company reported no income tax benefit for the three and six month periods ended June 30, 2020 and 2019. If the Company’s assumptions change and the Company believes that it will be able to realize these deferred tax assets, the tax benefits relating to any reversal of the valuation allowance on deferred tax assets will be recognized as a reduction of future income tax expense.  If the assumptions do not change, each period the Company could record an additional valuation allowance on any increases in the deferred tax assets.

 

On March 27, 2020, the U.S. government enacted the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”) which includes modifications to the limitation on business interest expense and net operating loss provisions, and provides a payment delay of employer payroll taxes during 2020 after the date of enactment. The CARES Act is not expected to have a material impact on the Company’s consolidated financial statements.

 

v3.20.2
Related Party Transactions
6 Months Ended
Jun. 30, 2020
Related Party Transactions  
Related Party Transactions

13. Related Party Transactions (in thousands, except per share data)

 

On September 28, 2018, Private NeuroBo entered into a five year manufacturing and supply agreement with Dong-A ST for manufacturing and supply of NB-01 drug substance and placebos for the purpose of research and development to be used in Phase 3 clinical trials (the “Manufacturing Agreement”).  The Company recognized no product manufacturing related costs under the Manufacturing Agreement for the three month and six month periods ended June 30, 2020, and $309 and $314 during the three and six month periods ended June 30, 2019, respectively. The product manufacturing related costs, when incurred, are reflected as research and development expenses.

 

The Manufacturing Agreement will automatically terminate in the event that the license agreement with Dong-A ST is terminated for any reason. In addition, each of Dong-A ST and Private NeuroBo may terminate the Manufacturing Agreement (1) upon the material breach by the other party, if the breach is not cured within a specified number of days after receiving notice from the terminating party, or if the breach cannot reasonably be cured within such period and the breaching party has not started to remedy the breach within such period and diligently endeavored to cure the breach within a reasonable time thereafter, or (2) in the event that (i) the other party is the subject of a petition for bankruptcy, reorganization, or arrangement and the same is not dismissed within thirty days thereof, (ii) a receiver or trustee is appointed for all or a substantial portion of the assets of the other party, or (iii) the other party makes an assignment for the benefit of its creditors.

On June 7, 2020, the Company entered into a manufacturing and supply agreement (the “Manufacturing and Supply Agreement”) with Dong-A ST for the manufacturing and supply of NB-02 drug product and placebo for the purpose of research and development of NB-02, including but not limited to, the use in the first NB-02 human clinical trial to be conducted by the Company. Under the terms of the Manufacturing and Supply Agreement, upon receipt of a purchase order from the Company no later than 270 days prior to the requested delivery date, Dong-A ST has agreed to produce for the Company tablets of the NB-02 drug substance and placebos at a specified supply price. The Company is obligated to manufacture, or have manufactured, and supply to Dong-A the active pharmaceutical ingredients which are necessary to manufacture the NB-02 drug product. The Manufacturing and Supply Agreement has a five year term, subject to earlier termination under certain circumstances.

 

v3.20.2
Summary of Significant Accounting Policies (Policies)
6 Months Ended
Jun. 30, 2020
Summary of Significant Accounting Policies  
Use of Estimates

Use of estimates

 

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, expenses, and related disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of expenses during the reporting period. The most significant estimates in Company's consolidated financial statements relate to accrued expenses and the fair value of stock-based compensation and warrant issuances. The Company bases its estimates on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgements about the carrying values of assets and liabilities. Actual results could differ from those estimates. Changes in estimates are reflected in reported results in the period in which they become known.

Concentration of Credit Risk

Concentration of Credit Risk

 

Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash. The Company’s cash is principally held by one financial institution in the United States. Amounts on deposit may at times exceed federally insured limits. Management believes that the financial institution is financially sound, and accordingly, minimal credit risk exists with respect to the financial institution. As of June 30, 2020, the Company had deposits in excess of federally insured amounts by $13.7 million.

Fair Value of Financial Instruments

 

Fair Value of Financial Instruments

 

The Company’s financial instruments include principally cash, prepaid, other current assets, right of use assets, accounts payable, accrued liabilities, lease liabilities, convertible debt and preferred stock. The carrying amounts of prepaid expenses, accounts payable, and accrued liabilities are reasonable estimates of their fair value because of the short maturity of these items.

General and Administrative Expenses

General and Administrative Expenses

 

General and administrative expenses consist primarily of personnel‑related costs, including salaries and stock-based compensation costs, for personnel in functions not directly associated with research and development activities. Other significant costs include legal fees related to intellectual property and corporate matters and professional fees for accounting and other services.

Research and Development Costs

Research and Development Costs

 

Research and development costs are charged to expense as incurred. Research and development expenses are comprised of costs incurred in performing research and development activities, including clinical trial costs, manufacturing costs for both clinical and pre-clinical materials as well as other contracted services, license fees, and other external costs. Nonrefundable advance payments for goods and services that will be used in future research and development activities are expensed when the activity is performed or when the goods have been received, rather than when payment is made, in accordance with Accounting Standards Codification (“ASC”) 730, Research and Development.

Income Taxes

Income Taxes

 

The Company utilizes the liability method of accounting for income taxes as required by ASC 740, Income Taxes. Under this method, deferred tax assets and liabilities are determined based on differences between financial reporting and the tax basis of assets and liabilities and are measured using enacted tax rates and laws that will be in effect when the differences are expected to reverse. Currently, there is no provision for income taxes, as the Company has incurred operating losses to date, and a full valuation allowance has been provided on the net deferred tax assets.

Stock-Based Compensation

Stock‑Based Compensation

 

The Company accounts for stock‑based compensation in accordance with the provisions of ASC 718, Compensation — Stock Compensation (“ASC 718”). Accordingly, compensation costs related to equity instruments granted are recognized at the grant‑date fair value. The Company records forfeitures when they occur. Stock-based compensation arrangements to non‑employees are accounted for in accordance with the applicable provisions of ASC 718 using a fair value approach.

Convertible Notes

Convertible Notes

 

The Company evaluates all conversion and redemption features contained in a debt instrument to determine if there are any embedded features that require bifurcation as a derivative or separation as a beneficial conversion feature. The host debt instrument is discounted for the value of any embedded feature that is accounted for as either a derivative or a beneficial conversion feature. The discount is amortized and recorded to interest expense over the term of the host debt instrument using the effective interest method. The Company’s convertible debt contained an embedded beneficial conversion feature that was separated and recorded as additional paid-in capital.

Fair Value of Common Stock

Fair Value of common stock

 

In the absence of a public trading market prior to the Merger, and as a development stage company with no significant revenues, the Company believed that it was appropriate to consider a range of factors to determine the fair value of the common stock at each grant date. In determining the fair value of its common stock, the Company used methodologies, approaches, and assumptions consistent with the American Institute of Certified Public Accountants' (“AICPA”) Audit and Accounting Practice Aid Series: Valuation of Privately Held Company Equity Securities Issued as Compensation (the "AICPA Practice Guide"). The valuations of Private NeuroBo common stock were prepared using a hybrid method, which used market approaches to estimate the enterprise value of Private NeuroBo. The hybrid method is a probability-weighted expected return method ("PWERM"), where the equity value in one or more of the scenarios is calculated using an option pricing method ("OPM"). The PWERM is a scenario-based methodology that estimates the fair value of common stock based upon an analysis of future values for Private NeuroBo, assuming various outcomes. The common stock value was based on the probability-weighted present value of expected future investment returns considering each of the possible outcomes available as well as the rights of each class of stock. The future value of the common stock under each outcome was discounted back to the valuation date at an appropriate risk-adjusted discount rate and probability weighted to arrive at an indication of value for the common stock. A discount for lack of marketability of the common stock was then applied to arrive at an indication of value for the common stock. The OPM treats common stock and preferred stock as call options on the total equity value of a company, with exercise prices based on the value thresholds at which the allocation among the various holders of a company's securities changes. Under this method, the common stock has value only if the funds available for distribution to stockholders exceeded the value of the preferred stock liquidation preferences at the time of the liquidity event, such as a strategic sale or a merger. In addition, the Company considered various objective and subjective factors, along with input from an independent third-party valuation firm. The factors included (1) the achievement of technical and operational milestones by the Company; (2) the status of strategic relationships with collaborators; (3) the significant risks associated with the Company's stage of development; (4) capital market conditions for life science companies and, in particular, similarly situated, privately held, early-stage life science companies; (5) the Company's available cash, financial condition, and results of operations; (6) the most recent sales of the Company's preferred stock to the extent they were with outside parties; and (7) the preferential rights of the outstanding preferred stock.

Leases

Leases

 

On July 1, 2019, the Company adopted Accounting Standards Update (“ASU”) No. 2016-02, Leases (Topic 842) (“ASU 2016-02”). The Company assesses its contracts at inception to determine whether the contract contains a lease, including evaluation of whether the contract conveys the right to control an explicitly or implicitly identified asset for a period of time. The Company has recognized right-of-use assets and lease liabilities that represent the net present value of future operating lease payments utilizing a discount rate corresponding to the Company’s incremental borrowing rate and amortized over the remaining terms of the leases. For operating leases of a short-term nature, i.e., those with a term of less than twelve months, the Company recognizes lease payments as an expense on a straight-line basis over the remaining lease term. 

Property and Equipment

Property and Equipment

 

Property and equipment is recorded at cost and reduced by accumulated depreciation. Depreciation expense is recognized over the estimated useful lives of the assets using the straight-line method. The estimated useful life for property and equipment ranges from three to five years. Tangible assets acquired for research and development activities and that have an alternative use are capitalized over the useful life of the acquired asset. Estimated useful lives are periodically reviewed, and when appropriate, changes are made prospectively. When certain events or changes in operating conditions occur, asset lives may be adjusted and an impairment assessment may be performed on the recoverability of the carrying amounts. Maintenance and repairs are charged directly to expense as incurred.

 

Foreign Currency Translation

Foreign Currency Translation

 

The foreign subsidiary uses the local currency as the functional currency. The Company translates the assets and liabilities of its foreign operation into U.S. dollars based on the rates of exchange in effect as of the balance sheet date. Expenses are translated into U.S. dollars using average exchange rates for each period. The resulting adjustments from the translation process are included in accumulated other comprehensive loss in the accompanying condensed consolidated balance sheets.

 

Certain transactions of the Company are settled in foreign currency and are thus translated to U.S. dollars at the rate of exchange in effect at the end of each month. Gains and losses resulting from the translation are included in other income or expense in the accompanying condensed consolidated statements of operations and comprehensive loss.

 

Patent Costs

Patent Costs

 

Costs related to filing and pursuing patent applications are expensed as incurred, as recoverability of such expenditures is uncertain. These costs are included in general and administrative expenses.

 

Comprehensive Loss

Comprehensive Loss

 

Comprehensive loss is comprised of net loss and other comprehensive income or loss. Comprehensive loss includes net loss as well as other changes in stockholders' equity (deficit) that result from transactions and economic events other than those with stockholders. Comprehensive loss currently consists of net loss and changes in foreign currency translation adjustments.

 

Segment Information

Segment Information

 

Operating segments are components of an enterprise for which separate financial information is available and is evaluated regularly by the Company’s chief operating decision maker in deciding how to allocate resources and assessing performance. The Company’s chief operating decision maker is its Chief Executive Officer. The Company’s Chief Executive Officer views the Company’s operations and manages its business in one operating segment, which is principally the business of development and commercialization of therapeutics.

Recent Accounting Pronouncements

Recent Accounting Pronouncements Adopted

 

From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board ("FASB") or other standard setting bodies that are adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on its consolidated financial position or results of operations upon adoption.

 

In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement (ASU 2018-13). The new guidance modifies the disclosure requirements in Topic 820 as follows:

 

·

Removals: the amount of and reasons for transfers between Level 1 and Level 2 of the fair value hierarchy; the policy for timing of transfers between levels; and the valuation processes for Level 3 fair value measurements.

·

Modifications: for investments in certain entities that calculate net asset value, an entity is required to disclose the timing of liquidation of an investee’s assets and the date when restrictions from redemption might lapse only if the investee has communicated the timing to the entity or announced the timing publicly; and the amendments clarify that the measurement uncertainty disclosure is to communicate information about the uncertainty in measurement as of the reporting date.

·

Additions: the changes in unrealized gains and losses for the period included in other comprehensive income for recurring Level 3 fair value measurements held at the end of the reporting period; and the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements.

This guidance is effective for all entities for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019. The amendments on changes in unrealized gains and losses, the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements, and the narrative description of measurement uncertainty should all be applied prospectively for only the most recent interim or annual period presented in the initial year of adoption. All other amendments should be applied retrospectively to all periods presented upon their effective date. Early adoption is permitted. The Company adopted the new guidance on January 1, 2020. The guidance did not have a material impact on the consolidated financial statements.

 

Recent Accounting Pronouncements Not Yet Adopted

 

In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740) which amends the existing guidance relating to the accounting for income taxes. This ASU is intended to simplify the accounting for income taxes by removing certain exceptions to the general principles of accounting for income taxes and to improve the consistent application of GAAP for other areas of accounting for income taxes by clarifying and amending existing guidance. The ASU is effective for fiscal years beginning after December 15, 2020. The Company does not expect that the adoption of this new guidance will have a material impact on the Company’s consolidated financial statements.

v3.20.2
Balance Sheet Detail (Tables)
6 Months Ended
Jun. 30, 2020
Balance Sheet Detail  
Schedule of property and equipment

 

 

 

 

 

 

 

 

 

 

 

As of

 

 

 

June 30,

 

 

December 31,

 

 

 

2020

 

 

2019

 

Research and development equipment

 

$

153

 

 

$

158

 

Office equipment

 

 

59

 

 

 

59

 

Total property and equipment

 

 

212

 

 

 

217

 

Less accumulated depreciation

 

 

(40)

 

 

 

(17)

 

Property and equipment, net

 

$

172

 

 

$

200

 

 

 

 

 

 

 

 

 

 

 

Schedule of accrued liabilities

 

 

 

 

 

 

 

 

 

    

June 30,

 

December 31,

 

 

 

2020

 

2019

 

External research and development expenses

 

$

1,197

 

$

915

 

Professional services

 

 

167

 

 

158

 

Payroll related

 

 

27

 

 

160

 

Other

 

 

35

 

 

189

 

Total

 

$

1,426

 

$

1,422

 

 

 

 

 

 

 

 

 

 

v3.20.2
Commitments and Contingencies (Tables)
6 Months Ended
Jun. 30, 2020
Schedule of future minimum payments of other commitments

As of June 30, 2020, future minimum payments under the agreement, which is cancellable annually at the end of each research year, are as follows (in thousands):

 

 

 

 

 

 

 

 

December 31,

 

 

 

 

 

 

2020

(period from July 1 to December 31)

$

66

 

2021

 

 

220

 

2022

 

 

220

 

 

 

$

506

 

 

Head Quarters in Boston Lease  
Schedule that reconciles the undiscounted lease liabilities to the total lease liabilities recognized on the unaudited consolidated balance sheet

Future minimum lease payments at June 30, 2020 were as follows under the New Boston Lease (in thousands):

 

 

 

 

 

 

 

 

December 31,

 

 

 

 

 

 

2020 (period from July 1 to December 31)

 

$

129

 

2021

 

 

21

 

Total minimum payments

 

$

150

 

 

 

 

 

 

 


The following table reconciles the undiscounted lease liabilities to the total lease liabilities recognized on the consolidated balance sheet as of June 30, 2020 (in thousands):

 

 

 

 

 

 

 

 

 

 

 

December 31,

 

2020 (period from July 1 to December 31)

 

$

16

 

2021

 

 

32

 

2022

 

 

32

 

2023

 

 

32

 

2024

 

 

16

 

Total lease payments

 

 

128

 

Less effect of discounting

 

 

(23)

 

 Total

 

 

105

 

Short-term portion

 

 

(23)

 

Long-term portion

 

$

82

 

 

v3.20.2
Stockholders’ Equity (Deficit) (Tables)
6 Months Ended
Jun. 30, 2020
Stockholders’ Equity  
Schedule of Gemphire warrants assumed in the Merger

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Exercise Price

 

 

Number Outstanding

 

 

Expiration Date

 

Number Exercisable

 

 

 

$

186.75

 

 

 

1,440

 

 

July 2028

 

 

1,440

 

 

 

$

260.00

 

 

 

39,115

 

 

March 2022

 

 

39,115

 

 

Total outstanding December 31, 2019

 

 

40,555

 

 

 

 

 

40,555

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

$

12.50

 

 

 

37,500

 

 

April 2025

 

 

37,500

 

 

Total outstanding June 30, 2020

 

 

78,055

 

 

 

 

 

78,055

 

 

v3.20.2
Stock-Based Compensation (Tables)
6 Months Ended
Jun. 30, 2020
Stock-Based Compensation  
Schedule of share-based compensation expense

Stock-based compensation expense was included in general and administrative and research and development costs as follows in the accompanying statements of comprehensive loss (in thousands):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

 

Six Months Ended

 

 

June 30, 

 

 

June 30, 

 

 

 

2020

    

 

2019

 

    

 

2020

 

    

2019

 

Research and development

$

4

 

$

16

 

 

$

18

 

$

55

 

General and administrative

 

167

 

 

63

 

 

 

312

 

 

84

 

Total stock-based compensation

$

171

 

$

79

 

 

$

330

 

$

139

 

 

Schedule of stock option plan activity

 

 

 

 

 

 

 

 

Six Months Ended

 

 

 

June 30, 

 

 

 

2020

 

2019

 

Outstanding on January 1

 

633,277

 

 

Granted

 

360,000

 

960,204

 

Exercised

 

(84,589)

 

 

Forfeited/Cancelled

 

 

 

Outstanding on June 30

 

908,688

 

960,204

 

 

Schedule of weighted-average assumptions, option-pricing model

 

 

 

 

 

 

 

 

 

 

 

Six Months Ended

 

 

 

June 30,

 

    

 

2020

    

2019

 

 

 

 

 

 

 

 

Expected stock price volatility

 

 

77.5

%

 

75.0

%

Expected life of options (years)

 

 

5.8

 

 

10.0

 

Expected dividend yield

 

 

0

%

 

0

%

Risk free interest rate

 

 

1.71

%

 

2.75

%

 

v3.20.2
Net Loss Per Common Share (Tables)
6 Months Ended
Jun. 30, 2020
Net Loss Per Common Share  
Schedule of potential common shares not considered in computation of diluted net loss per share

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

Six Months Ended

 

 

 

 

 

June 30,

 

June 30,

 

 

 

 

    

2020

    

2019

    

2020

    

2019

 

 

 

Redeemable preferred stock

 

 —

 

8,264,613

 

 —

 

8,264,613

 

 

 

Convertible notes

 

 —

 

1,531,268

 

 —

 

1,531,268

 

 

 

Stock options

 

908,688

 

960,204

 

908,688

 

960,204

 

 

 

Warrants

 

78,055

 

 —

 

78,055

 

 —

 

 

 

 

v3.20.2
The Company and Basis of Presentation (Details)
$ / shares in Units, $ in Thousands
2 Months Ended 12 Months Ended
Apr. 13, 2020
USD ($)
$ / shares
shares
Aug. 11, 2019
Jul. 24, 2019
Jun. 30, 2019
USD ($)
Dec. 31, 2018
USD ($)
Jun. 30, 2020
USD ($)
Dec. 31, 2019
USD ($)
Sale of Stock              
Cash           $ 14,298 $ 13,908
Accumulated deficit           $ (43,980) $ (36,866)
Reverse stock split, ratio   0.0001          
Series A Redeemable Convertible Preferred Stock              
Sale of Stock              
Net proceeds         $ 16,800    
Registered Offering              
Sale of Stock              
Issuance of common stock in connection with equity financing (in shares) | shares 750,000            
Offering shares (Per share) | $ / shares $ 10            
Gross proceeds $ 7,500            
Convertible notes              
Sale of Stock              
Net proceeds         $ 500    
Series B Redeemable Convertible Preferred Stock              
Sale of Stock              
Net proceeds       $ 24,200      
Merger Agreement with NeuroBo              
Sale of Stock              
Reverse stock split, ratio     1.1431        
Percentage of interest held by our exiting shareholders     96.20%        
v3.20.2
Summary of Significant Accounting Policies (Details)
$ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2020
USD ($)
Jun. 30, 2019
USD ($)
Jun. 30, 2020
USD ($)
segment
Jun. 30, 2019
USD ($)
Concentration of Credit Risk        
Deposits in excess of federally insured amounts $ 13,700   $ 13,700  
Income Taxes        
Provision (benefit) for income taxes $ 0 $ 0 $ 0 $ 0
Segment Information        
Number of operating segment | segment     1  
Minimum        
Estimated useful life     3 years  
Maximum        
Estimated useful life     5 years  
v3.20.2
Balance Sheet Detail (Details) - USD ($)
$ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2020
Jun. 30, 2019
Jun. 30, 2020
Jun. 30, 2019
Dec. 31, 2019
Balance Sheet Detail          
Total property and equipment $ 212   $ 212   $ 217
Less accumulated depreciation (40)   (40)   (17)
Property and equipment, net 172   172   200
Depreciation 12 $ 1 23 $ 1  
Research and development equipment          
Balance Sheet Detail          
Total property and equipment 153   153   158
Office equipment          
Balance Sheet Detail          
Total property and equipment $ 59   $ 59   $ 59
v3.20.2
Balance Sheet Detail - Accrued Liabilities (Details) - USD ($)
$ in Thousands
6 Months Ended
Jun. 30, 2020
Dec. 31, 2019
External research and development expenses $ 1,197 $ 915
Professional services 167 158
Payroll related 27 160
Other 35 189
Total 1,426 $ 1,422
Amount of termination expenses 675  
Amount of research and development expenses related to clinical trial expenses 186  
Minimum    
Amount of loss on contract 0  
Maximum    
Amount of loss on contract $ 1,100  
v3.20.2
Merger - Contingent Value Rights Agreement (Details) - USD ($)
$ in Millions
6 Months Ended
Jun. 30, 2020
Jul. 23, 2019
Merger Agreement    
Percentage of gross consideration 80.00%  
Contingent value rights term 15 years  
Contingent value rights term incase of other than grant, sale or transfer 10 years  
Commitment to support develop gemcabene $ 1.0  
License Agreement with Beijing SL    
Merger Agreement    
Upfront payment to be received   $ 2.5
v3.20.2
Commitments and Contingencies - Operating Leases - (Details) - USD ($)
$ in Thousands
1 Months Ended 3 Months Ended 6 Months Ended
Sep. 30, 2019
May 31, 2019
Jun. 30, 2020
Jun. 30, 2019
Jun. 30, 2020
Jun. 30, 2019
Dec. 31, 2019
Commitments and Contingencies              
Right-of-use assets     $ 105   $ 105   $ 116
Operating lease, liability current     23   23   $ 22
Operating lease, liability noncurrent     $ 82   82    
Non-cash expense related to Korea lease         10    
Operating lease cash payments         $ 10    
Korea              
Commitments and Contingencies              
Term of contract   5 years          
Lease expense       $ 0   $ 0  
Option to renew   true          
Renewal term   5 years          
Right-of-use assets $ 126            
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] us-gaap:OtherCurrentLiabilitiesMember            
Operating lease, liability current $ 20            
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] us-gaap:OtherNoncurrentLiabilitiesMember            
Operating lease, liability noncurrent $ 106            
Operating lease discount rate     10.00%   10.00%    
Weighted average remaining lease term     4 years   4 years    
Non-cash expense related to Korea lease     $ 8   $ 16    
Operating lease cash payments       0 16 0  
Head Quarters in Boston Lease              
Commitments and Contingencies              
Term of contract 1 year            
Monthly rental cost $ 21            
Rent concessions granted by the landlord $ 32            
Lease expense     65 27 $ 180 $ 53  
Termination fee     $ 83 $ 83      
v3.20.2
Commitments and Contingencies - Operating Lease - Lease liabilities (Details) - USD ($)
$ in Thousands
Jun. 30, 2020
Dec. 31, 2019
Maturity of the lease liability was as follows (in thousands):    
2020 $ 16  
2021 32  
2022 32  
2023 32  
2024 16  
Total lease payments 128  
Less effect of discounting (23)  
Total 105  
Short-term portion (23) $ (22)
Long-term portion 82  
Head Quarters in Boston Lease    
Maturity of the lease liability was as follows (in thousands):    
2020 129  
2021 21  
Total lease payments $ 150  
v3.20.2
Commitments and Contingencies - Xiehecheng Cultivation Service Agreement (Details) - Xiehecheng Chinese Herm Limited Corporation - Cultivation Service Agreement
$ in Thousands
Jun. 30, 2020
USD ($)
Other Commitments [Line Items]  
2020 $ 66
2021 220
2022 220
Other Commitment, Total $ 506
v3.20.2
Commitments and Contingencies - Pfizer License Agreement (Details)
$ in Thousands
1 Months Ended 6 Months Ended
Mar. 31, 2015
USD ($)
Jun. 30, 2020
USD ($)
Mar. 31, 2020
USD ($)
Commitments and Contingencies      
Milestones or royalty payments triggered   $ 0  
Termination fee     $ 675
Minimum      
Commitments and Contingencies      
Amount of estimated loss   0  
Maximum      
Commitments and Contingencies      
Amount of estimated loss   1,100  
License Agreement      
Commitments and Contingencies      
Termination fee   $ 3,000  
Pfizer, Inc. | License Agreement      
Commitments and Contingencies      
Number of years after the first commercial sale P5Y    
Notice period 90 days    
Pfizer, Inc. | License Agreement | Milestone Payments | Maximum      
Commitments and Contingencies      
Potential payments upon achievement of certain milestones 37,000    
v3.20.2
License Agreement - Beijing (Details) - USD ($)
$ in Thousands
6 Months Ended
Jul. 23, 2019
Jun. 30, 2020
License Agreements    
Minimum expected period to begin future installment payment 1 year  
Maximum    
License Agreements    
Clinical supply agreement execution period from effective date 12 months  
License Agreement with Beijing SL    
License Agreements    
Revenue recognized from the agreement   $ 0
Upfront payment to be received $ 2,500  
Period from effective date within which upfront gross payment to be paid 45 days  
Developmental and regulatory milestone payment eligible to be received $ 6,000  
Global net sales milestone payment to be received $ 20,000  
License Agreement with Beijing SL | Maximum    
License Agreements    
Percentage of royalty on net sales 20.00%  
v3.20.2
Debt (Details) - USD ($)
$ / shares in Units, $ in Thousands
1 Months Ended 3 Months Ended 6 Months Ended
Dec. 30, 2019
Oct. 22, 2019
Feb. 28, 2018
Jun. 30, 2019
Jun. 30, 2019
Jun. 30, 2020
Oct. 23, 2019
Debt              
Conversion price             $ 0.40
Convertible notes              
Debt              
Proceeds from debt issued     $ 500        
Shares issued on debt conversion 1,565,300            
Conversion price             $ 0.40
Convertible interest rate (as a percentage)           5.00%  
Interest on principal       $ 7 $ 13    
Debt beneficial conversion feature   $ 401          
Amortization of debt discount       $ 8 $ 16    
v3.20.2
Stockholders’ Equity (Deficit) (Details)
$ / shares in Units, $ in Thousands
3 Months Ended 6 Months Ended
Apr. 13, 2020
USD ($)
$ / shares
shares
Jun. 30, 2020
USD ($)
$ / shares
shares
Jun. 30, 2019
USD ($)
Jun. 30, 2020
USD ($)
Vote / shares
$ / shares
Jun. 30, 2019
USD ($)
Dec. 31, 2019
$ / shares
Voting Rights            
Warrants exercise price | $ / shares   $ 302,020.00   $ 302,020.00   $ 312,019.00
Risk free interest rate       1.71% 2.75%  
Expected stock price volatility       77.50% 75.00%  
Expected life of options (years)       5 years 9 months 18 days 10 years  
Expected dividend yield       0.00% 0.00%  
Issuance costs     $ 65 $ 695 $ 65  
Registered Offering            
Voting Rights            
Shares issued (in shares) | shares 750,000          
Offering shares (Per share) | $ / shares $ 10          
Gross proceeds $ 7,500          
Cash commission (Percent) 7.00%          
Warrants to purchase shares of common stock | shares 37,500          
Warrants to purchase shares of common stock, Percentage | shares 5.0          
Warrants exercise price | $ / shares $ 12.50          
Warrant exercise price, percentage 125.00%          
Fair market value of warrant   $ 289   $ 289    
Risk free interest rate       0.40%    
Expected stock price volatility       78.00%    
Expected life of options (years)       5 years    
Expected dividend yield       0.00%    
Issuance costs   1,000   $ 1,000    
Cash commissions   500   500    
Legal and other fees   200   200    
Placement agents warrants   300   $ 300    
Common Stock            
Common Stock            
Common stock, vote per share | Vote / shares       1    
Dividends Rights            
No dividends declared   $ 0   $ 0    
Voting Rights            
Common stock, vote per share | Vote / shares       1    
Shares issued (in shares) | shares   750,000        
v3.20.2
Stockholders’ Equity (Deficit) - Warrants (Details) - $ / shares
Jun. 30, 2020
Dec. 31, 2019
Warrants    
Exercise price $ 302,020.00 $ 312,019.00
Number Outstanding 78,055 40,555
Number Exercisable 78,055 40,555
$186.75    
Warrants    
Exercise price $ 186.75  
Number Outstanding 1,440  
Number Exercisable 1,440  
$260.00    
Warrants    
Exercise price $ 260.00  
Number Outstanding 39,115  
Number Exercisable 39,115  
$12.50    
Warrants    
Exercise price $ 12.50  
Number Outstanding 37,500  
Number Exercisable 37,500  
v3.20.2
Stock-Based Compensation (Details) - USD ($)
$ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2020
Jun. 30, 2019
Jun. 30, 2020
Jun. 30, 2019
Stock-Based Compensation        
Share-based compensation $ 171 $ 79 $ 330 $ 139
Research and development        
Stock-Based Compensation        
Share-based compensation 4 16 18 55
General and administrative        
Stock-Based Compensation        
Share-based compensation $ 167 $ 63 $ 312 $ 84
v3.20.2
Stock-Based Compensation - Stock Options (Details) - $ / shares
6 Months Ended
Jun. 30, 2020
Jun. 30, 2019
Dec. 31, 2019
Stock Options, Additional Disclosures      
Granted (in shares) 360,000 960,204  
Stock options outstanding 908,688 960,204 633,277
Stock options      
Stock Options, Additional Disclosures      
Granted (in shares) 360,000 960,204  
Stock options outstanding 908,688   633,277
Weighted average fair value per share of options granted $ 5.59 $ 0.50  
Stock options | Maximum      
Stock Options, Additional Disclosures      
Expiration period 10 years    
v3.20.2
Stock-Based Compensation - Stock opption plan activity (Details) - shares
6 Months Ended
Jun. 30, 2020
Jun. 30, 2019
Stock option plan activity    
Outstanding, Number, Beginning Balance (in shares) 633,277  
Granted (in shares) 360,000 960,204
Exercised (in shares) (84,589)  
Outstanding, Number, Ending Balance (in shares) 908,688 960,204
v3.20.2
Stock-Based Compensation - Assumptions (Details)
6 Months Ended
Jun. 30, 2020
Jun. 30, 2019
Stock-Based Compensation    
Expected stock price volatility 77.50% 75.00%
Expected life of options (years) 5 years 9 months 18 days 10 years
Expected dividend yield 0.00% 0.00%
Risk free interest rate 1.71% 2.75%
v3.20.2
Stock-Based Compensation - Evergreen provision (Details) - USD ($)
$ in Millions
3 Months Ended 6 Months Ended
Jan. 01, 2020
Jun. 30, 2020
Mar. 31, 2020
Jun. 30, 2019
Mar. 31, 2019
Jun. 30, 2020
Jun. 30, 2019
Stock options              
Number of Options              
Forfeited, nonvested     0   0    
2019 Plan              
Number of Options              
Period of automatic increase in shares reserved           10 years  
Percentage of the common shares outstanding (as a percent)           4.00%  
Number of shares added (In shares) 623,708            
Available for future issuance   4,127,179       4,127,179  
2019 Plan | Stock options              
Number of Options              
Vested   44,289   37,150   87,151 157,176
Stock Plan 2018 And 2019 Plans              
Unrecognized share-based compensation              
Unrecognized share-based compensation cost   $ 1.7       $ 1.7  
Unrecognized share-based compensation - Weighted average period           2 years 6 months  
Maximum | 2019 Plan              
Number of Options              
Aggregate maximum number of shares of common stock that may be issued   6,680,000       6,680,000  
v3.20.2
Redeemable Preferred Stock (Details) - USD ($)
1 Months Ended 2 Months Ended
Dec. 30, 2019
Apr. 30, 2018
Jun. 30, 2019
Series A and Series B Redeemable Convertible Preferred Stock      
Redeemable Preferred Stock      
Number of stock converted 8,264,613    
Conversion ratio 1    
Series A Redeemable Convertible Preferred Stock      
Redeemable Preferred Stock      
Shares issued (in shares)   $ 4,801,020  
Shares price (in dollars per share)   $ 3.50  
Gross proceeds   $ 16,800,000  
Series B Redeemable Convertible Preferred Stock      
Redeemable Preferred Stock      
Shares issued (in shares)     $ 3,463,593
Shares price (in dollars per share)     $ 7.00
Gross proceeds     $ 24,240,000
v3.20.2
Net Loss Per Common Share - Antidilutive Securities (Details) - shares
3 Months Ended 6 Months Ended
Jun. 30, 2020
Jun. 30, 2019
Jun. 30, 2020
Jun. 30, 2019
Redeemable preferred stock        
Potential common shares        
Potential common shares   8,264,613   8,264,613
Convertible notes        
Potential common shares        
Potential common shares   1,531,268   1,531,268
Stock options        
Potential common shares        
Potential common shares 908,688 960,204 908,688 960,204
Warrants        
Potential common shares        
Potential common shares 78,055   78,055  
v3.20.2
Income Taxes (Details) - USD ($)
$ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2020
Mar. 31, 2020
Jun. 30, 2019
Mar. 31, 2019
Jun. 30, 2020
Jun. 30, 2019
Income Taxes            
Effective tax rate   0.00%   0.00%    
Income tax benefit (expense) $ 0   $ 0   $ 0 $ 0
v3.20.2
Related Party Transactions (Details) - Dong-A ST - Manufacturing Agreement - USD ($)
$ in Thousands
3 Months Ended 6 Months Ended
Sep. 28, 2018
Jun. 30, 2020
Jun. 30, 2019
Jun. 30, 2020
Jun. 30, 2019
Related Party Transactions          
Term of agreement 5 years        
Related Party Costs   $ 0 $ 309 $ 0 $ 314
Period for dismission of allegations.       30 days