10-Q 1 pstv-10q_20200930.htm 10-Q pstv-10q_20200930.htm

0q

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 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 September 30, 2020

OR

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

For the transition period from                 to                 

Commission file number 001-34375

 

PLUS THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

 

 

DELAWARE

 

33-0827593

(State or other jurisdiction

of incorporation or organization)

 

(I.R.S. Employer

Identification No.)

 

 

 

4200 MARATHON BLVD., SUITE 200, AUSTIN, TX

 

78756

(Address of principal executive offices)

 

(Zip Code)

 

(737) 255-7194

(Registrant’s telephone number, including area code)

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, par value $0.001 per share

PSTV

Nasdaq Capital Market

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 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 financing 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  

As of October 14, 2020, there were 4,779,584 shares of the registrant’s common stock outstanding.

 



PLUS THERAPEUTICS, INC.

INDEX

 

 

 

 

 

Page

PART I

 

FINANCIAL INFORMATION

 

 

 

 

 

 

 

 

 

Item 1.

 

Financial Statements (Unaudited)

 

4

 

 

 

 

 

 

 

 

 

 

 

Consolidated Condensed Balance Sheets

 

4

 

 

 

 

 

 

 

 

 

 

 

Consolidated Condensed Statements of Operations and Comprehensive Loss

 

5

 

 

 

 

 

 

 

 

 

 

 

Consolidated Condensed Statements of Stockholders’ Equity

 

6

 

 

 

 

 

 

 

 

 

 

 

Consolidated Condensed Statements of Cash Flows

 

7

 

 

 

 

 

 

 

 

 

 

 

Notes to Consolidated Condensed Financial Statements

 

8

 

 

 

 

 

 

 

 

 

Item 2.

 

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

 

19

 

 

 

 

 

 

 

 

 

Item 3.

 

Quantitative and Qualitative Disclosures about Market Risk

 

25

 

 

 

 

 

 

 

 

 

Item 4.

 

Controls and Procedures

 

25

 

 

 

 

 

 

 

PART II

 

OTHER INFORMATION

 

 

 

 

 

 

 

 

 

 

 

Item 1.

 

Legal Proceedings

 

26

 

 

 

 

 

 

 

 

 

Item 1A.

 

Risk Factors

 

26

 

 

 

 

 

 

 

 

 

Item 2.

 

Unregistered Sales of Equity Securities and Use of Proceeds

 

31

 

 

 

 

 

 

 

 

 

Item 5.

 

Other Information

 

31

 

 

 

 

 

 

 

 

 

Item 6.

 

Exhibits

 

33

 

2


CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

This report contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws.  All statements in this report, other than statements of historical fact, are forward-looking statements. These forward-looking statements may be identified by terms such as “intend,” “expect,” “believe,” “anticipate,” “will,” “should,” “would,” “could,” “may,” “designed,” “potential,” and similar expressions, or the negative of such expressions. Such statements are based upon certain assumptions and assessments made by our management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate.

These statements include, without limitation, statements regarding: our anticipated expenditures, including research and development, sales and marketing, and general and administrative expenses; our ability to benefit from the NIH/NCI award for continued clinical development of RNL™ for recurrent glioblastoma; the ability of RNL™ to safely and effectively deliver radiation directly to the tumor at large doses; the duration of any therapies employing RNL™; our ability to expand testing of RNL™ to additional sites; the potential size of the market for our products; future development and/or expansion of our products and therapies in our markets; our ability to generate product or development revenues and the sources of such revenue; the amounts that we will be obligated to pay under license agreements; our ability to effectively manage our gross profit margins; our ability to obtain and maintain regulatory approvals; expectations as to our future performance; portions of the “Liquidity and Capital Resources” section of this report; our need for additional financing and the availability thereof; our ability to sell shares of common stock to Lincoln Park Capital Fund, LLC pursuant to the terms of the purchase agreement that we have entered into with them and our ability to register and maintain the registration of the shares issued and issuable thereunder; our anticipated use of the net proceeds from the potential sale of shares of our common stock to Lincoln Park Capital Fund, LLC; any changes to our interest expenses; our ability to continue as a going concern; our ability to remain listed on the Nasdaq Capital Market; our ability to repay or refinance some or all of our outstanding indebtedness and our ability to raise capital in the future; our expectations as to the impact of recently issued or adopted accounting standards; our expectations as to the impact of the COVID-19 pandemic on our business and operating results; our beliefs as to the impact of any liability that may arise as a result of any legal proceedings; and the potential enhancement of our cash position through development, marketing, and licensing arrangements. Our actual results will likely differ, perhaps materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to: the early stage of our product candidates and therapies, the results of our research and development activities, including uncertainties relating to the clinical trials of our product candidates and therapies; our need and ability to raise additional cash, the outcome of our partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to us, market conditions, product performance, potential litigation, competition within the regenerative medicine field, and the COVID-19 pandemic. The forward-looking statements included in this report are also subject to a number of additional material risks and uncertainties, including but not limited to the risks described under “Part I - Item 1A - Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2019, and under “Part II, Item 1A - Risk Factors” in this Quarterly Report on Form 10-Q.  These risks and uncertainties that could cause actual results to differ materially from expectations or those expressed in these forward-looking statements.  We encourage you to read these risks carefully. We caution you not to place undue reliance on the forward-looking statements contained in this report. These statements, like all statements in this report, speak only as of the date of this report (unless an earlier date is indicated) and we undertake no obligation to update or revise the statements except as required by law.  

 

3


PART I. FINANCIAL INFORMATION

Item 1. Financial Statements

PLUS THERAPEUTICS, INC.

CONSOLIDATED CONDENSED BALANCE SHEETS

(UNAUDITED)

(in thousands, except share and par value data)

 

 

 

As of September 30,

2020

 

 

As of December 31,

2019

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

7,626

 

 

$

17,552

 

Accounts receivable

 

 

 

 

 

1,169

 

Restricted cash

 

 

 

 

 

40

 

Inventories, net

 

 

107

 

 

 

107

 

Other current assets

 

 

916

 

 

 

957

 

Total current assets

 

 

8,649

 

 

 

19,825

 

 

 

 

 

 

 

 

 

 

Property and equipment, net

 

 

1,943

 

 

 

2,179

 

Operating lease right-of-use assets

 

 

671

 

 

 

781

 

Other assets

 

 

18

 

 

 

72

 

Goodwill

 

 

372

 

 

 

372

 

Total assets

 

$

11,653

 

 

$

23,229

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable and accrued expenses

 

$

2,083

 

 

$

3,279

 

Operating lease liability

 

 

140

 

 

 

147

 

Term loan obligations, net of discount

 

 

6,181

 

 

 

11,060

 

Total current liabilities

 

 

8,404

 

 

 

14,486

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Noncurrent operating lease liability

 

 

545

 

 

 

646

 

Warrant liability

 

 

83

 

 

 

6,929

 

Other noncurrent liabilities

 

 

 

 

 

8

 

Total liabilities

 

 

9,032

 

 

 

22,069

 

 

 

 

 

 

 

 

 

 

Commitments and contingencies (Note 9)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

Preferred stock, $0.001 par value; 5,000,000 shares authorized; 1,954 and 1,959 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively

 

 

 

 

 

 

Common stock, $0.001 par value; 100,000,000 shares authorized; 4,591,415 and 3,880,588  shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively

 

 

5

 

 

 

4

 

Additional paid-in capital

 

 

432,540

 

 

 

426,426

 

Accumulated deficit

 

 

(429,924

)

 

 

(425,270

)

Total stockholders’ equity

 

 

2,621

 

 

 

1,160

 

Total liabilities and stockholders’ equity

 

$

11,653

 

 

$

23,229

 

 

See Accompanying Notes to these Consolidated Condensed Financial Statements

 

 

4


PLUS THERAPEUTICS, INC.

CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(UNAUDITED)

(in thousands, except share and per share data)

 

 

 

 

 

For the Three Months Ended September 30,

 

 

For the Nine Months Ended September 30,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Development revenues:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Government contracts and other

 

$

 

 

$

4,771

 

 

$

303

 

 

$

5,810

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

336

 

 

 

921

 

 

 

1,604

 

 

 

3,636

 

In process research and development acquired from NanoTx

 

 

 

 

 

 

 

 

781

 

 

 

 

Sales and marketing

 

 

104

 

 

 

94

 

 

 

319

 

 

 

305

 

General and administrative

 

 

956

 

 

 

1,076

 

 

 

3,788

 

 

 

3,313

 

Total operating expenses

 

 

1,396

 

 

 

2,091

 

 

 

6,492

 

 

 

7,254

 

Operating income (loss)

 

 

(1,396

)

 

 

2,680

 

 

 

(6,189

)

 

 

(1,444

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

2

 

 

 

6

 

 

 

47

 

 

 

20

 

Interest expense

 

 

(253

)

 

 

(366

)

 

 

(854

)

 

 

(1,477

)

Change in fair value of warrants

 

 

(81

)

 

 

(561

)

 

 

2,342

 

 

 

(69

)

Warrant issuance cost

 

 

 

 

 

(1,233

)

 

 

 

 

 

(1,233

)

Total other income (expense)

 

 

(332

)

 

 

(2,154

)

 

 

1,535

 

 

 

(2,759

)

Income (Loss) from continuing operations

 

 

(1,728

)

 

 

526

 

 

 

(4,654

)

 

 

(4,203

)

Loss from discontinued operations

 

 

 

 

 

 

 

 

 

 

 

(7,568

)

Net income (loss)

 

$

(1,728

)

 

$

526

 

 

$

(4,654

)

 

$

(11,771

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Income (Loss) from continuing operations

 

$

(1,728

)

 

$

526

 

 

$

(4,654

)

 

$

(4,203

)

Beneficial conversion feature for convertible preferred stock

 

 

 

 

 

(554

)

 

 

 

 

$

(554

)

Net loss allocable to common stockholders - continuing operations

 

$

(1,728

)

 

$

(28

)

 

$

(4,654

)

 

$

(4,757

)

Net loss allocable to common stockholders - discontinued operations

 

$

 

 

$

 

 

$

 

 

$

(7,568

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted net loss per share attributable to common stockholders - continuing operations

 

$

(0.39

)

 

$

(0.03

)

 

$

(1.13

)

 

$

(8.78

)

Basic and diluted net loss per share attributable to common stockholders - discontinued operations

 

$

 

 

$

 

 

$

 

 

$

(13.97

)

Net loss per share, basic and diluted

 

$

(0.39

)

 

$

(0.03

)

 

$

(1.13

)

 

$

(22.75

)

Basic and diluted weighted average shares used in calculating net loss per share attributable to common stockholders

 

 

4,402,221

 

 

 

826,548

 

 

 

4,113,928

 

 

 

541,777

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

See Accompanying Notes to these Consolidated Condensed Financial Statements

 

 

5


PLUS THERAPEUTICS, INC.

CONSOLIDATED CONDENSED STATEMENTS OF STOCKHOLDERS’ EQUITY

(UNAUDITED)

(in thousands)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

 

 

 

Convertible

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

 

other

 

 

 

 

 

 

 

 

Total

 

 

 

preferred stock

 

 

Common stock

 

 

 

paid-in

 

 

 

comprehensive

 

 

 

Accumulated

 

 

 

stockholders’

 

 

 

Shares

 

 

 

Amount

 

 

Shares

 

 

 

Amount

 

 

 

capital

 

 

 

income

 

 

 

deficit

 

 

 

equity

 

Balance at December 31, 2018

 

 

4,606

 

 

$

 

 

 

 

296,609

 

 

$

 

 

 

$

 

418,390

 

 

$

 

1,218

 

 

$

 

(414,383

)

 

$

 

5,225

 

Share-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

49

 

 

 

 

 

 

 

 

 

 

 

 

49

 

Sale of common stock, net

 

 

 

 

 

 

 

 

 

139,855

 

 

 

 

 

 

 

 

1,873

 

 

 

 

 

 

 

 

 

 

 

 

1,873

 

Conversion of Series B Convertible Preferred

     Stock into common stock

 

 

(66

)

 

 

 

 

 

 

1,653

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Foreign currency translation adjustment and

     accumulated other comprehensive income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(140

)

 

 

 

 

 

 

 

(140

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(3,150

)

 

 

 

(3,150

)

Balance at March 31, 2019

 

 

4,540

 

 

$

 

 

 

 

438,117

 

 

$

 

 

 

$

 

420,312

 

 

$

 

1,078

 

 

$

 

(417,533

)

 

$

 

3,857

 

Share-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

28

 

 

 

 

 

 

 

 

 

 

 

 

28

 

Sale of common stock, net

 

 

 

 

 

 

 

 

 

5,000

 

 

 

 

 

 

 

 

64

 

 

 

 

 

 

 

 

 

 

 

 

64

 

Foreign currency translation adjustment and

     accumulated other comprehensive income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(1,078

)

 

 

 

 

 

 

 

(1,078

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(9,147

)

 

 

 

(9,147

)

Balance at June 30, 2019

 

 

4,540

 

 

$

 

 

 

 

443,117

 

 

$

 

 

 

$

 

420,404

 

 

$

 

 

 

$

 

(426,680

)

 

$

 

(6,276

)

Share-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

29

 

 

 

 

 

 

 

 

 

 

 

 

29

 

Sale of common stock, pre-funded warrants and warrants for common stock, net of offering costs of $0.6 million

 

 

 

 

 

 

 

 

 

2,000,510

 

 

 

 

3

 

 

 

 

4,594

 

 

 

 

 

 

 

 

 

 

 

 

4,597

 

Conversion of Series B and Series C convertible preferred stock into common stock

 

 

(2,581

)

 

 

 

 

 

 

332,546

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Exercise of warrants

 

 

 

 

 

 

 

 

 

 

 

65,415

 

 

 

 

 

 

 

 

 

490

 

 

 

 

 

 

 

 

 

 

 

 

490

 

Warrant derivative liability reclasssified to equity due to exercise of warrants

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

794

 

 

 

 

 

 

 

 

 

 

 

 

794

 

Beneficial conversion feature related to Series C Convertible Preferred Stock

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

554

 

 

 

 

 

 

 

 

 

 

 

 

554

 

Accretion of beneficial conversion feature related to Series C Convertible Preferred Stock

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(554

)

 

 

 

 

 

 

 

 

 

 

 

(554

)

Net income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

526

 

 

 

 

526

 

Balance at September 30, 2019

 

 

1,959

 

 

$

 

 

 

 

2,841,588

 

 

$

 

3

 

 

$

 

426,311

 

 

$

 

 

 

$

 

(426,154

)

 

$

 

160

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at December 31, 2019

 

 

1,959

 

 

$

 

 

 

 

3,880,588

 

 

$

 

4

 

 

$

 

426,426

 

 

$

 

 

 

$

 

(425,270

)

 

$

 

1,160

 

Share-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

12

 

 

 

 

 

 

 

 

 

 

 

 

12

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(1,087

)

 

 

 

(1,087

)

Balance at March 31, 2020

 

 

1,959

 

 

$

 

 

 

 

3,880,588

 

 

$

 

4

 

 

$

 

426,438

 

 

$

 

 

 

$

 

(426,357

)

 

$

 

85

 

Issuance of common stock for exercise of warrants

 

 

 

 

 

 

 

 

 

162,500

 

 

 

 

 

 

 

 

366

 

 

 

 

 

 

 

 

 

 

 

 

366

 

Reclassification of warrant liabilities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4,264

 

 

 

 

 

 

 

 

 

 

 

 

4,264

 

Issuance of common stock for in process research and development acquired from NanoTx Therapeutics

 

 

 

 

 

 

 

 

 

230,769

 

 

 

 

 

 

 

 

381

 

 

 

 

 

 

 

 

 

 

 

 

381

 

Share-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

43

 

 

 

 

 

 

 

 

 

 

 

 

43

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(1,839

)

 

 

 

(1,839

)

Balance at June 30, 2020

 

 

1,959

 

 

$

 

 

 

 

4,273,857

 

 

$

 

4

 

 

$

 

431,492

 

 

$

 

 

 

$

 

(428,196

)

 

$

 

3,300

 

Issuance of common stock for exercise of warrants

 

 

 

 

 

 

 

 

 

317,521

 

 

 

 

1

 

 

 

 

714

 

 

 

 

 

 

 

 

 

 

 

 

715

 

Reclassification of warrant liabilities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

240

 

 

 

 

 

 

 

 

 

 

 

 

240

 

Conversion of Series B convertible preferred stock into common stock

 

 

(5

)

 

 

 

 

 

 

37

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Share-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

94

 

 

 

 

 

 

 

 

 

 

 

 

94

 

Net loss