UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 6-K

 

Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16

Under the Securities Exchange Act of 1934

 

For the Month of August 2019

 

001-36345

(Commission File Number)

 

GALMED PHARMACEUTICALS LTD.

(Exact name of Registrant as specified in its charter)

 

16 Tiomkin St.

Tel Aviv 6578317, Israel

(Address of principal executive offices)

 

Indicate by check mark whether the registrant files or will file annual reports under cover

Form 20-F or Form 40-F.

 

Form 20-F  x   Form 40-F  ¨

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by

Regulation S-T Rule 101(b)(1): ____

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by

Regulation S-T Rule 101(b)(7): ____

 

 

  

  

 

 

This Form 6-K contains the quarterly report of Galmed Pharmaceuticals Ltd. (the “Company”), which includes the Company’s unaudited consolidated financial statements for the three and six months ended June 30, 2019, together with related information and certain other information. The Company is not subject to the requirements to file quarterly or certain other reports under Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended. The Company does not undertake to file or cause to be filed any such reports in the future, except to the extent required by law.

 

On August 5, 2019, the Company issued a press release announcing the filing of its financial results for the three and six months ended June 30, 2019 with the Securities and Exchange Commission. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

 

This Form 6-K and the text under the heading “Financial Summary - Second Quarter 2019 vs. Second Quarter 2018” in Exhibit 99.1 is incorporated by reference into the Company’s Registration Statement on Form S-8 (Registration No. 333-206292 and 333-227441) and the Company’s Registration Statement on Form F-3 (Registration No. 333-223923). 

  

  

 

 

  FINANCIAL INFORMATION

 

Financial Statements

  

GALMED PHARMACEUTICALS LTD.
Consolidated Balance Sheets
U.S. Dollars in thousands, except share data and per share data

 

   As of
June 30,
2019
   As of
December 31,
2018
 
   Unaudited   Audited 
Assets          
Current assets          
Cash and cash equivalents  $25,778   $24,159 
Short-term deposits   15,282    6,067 
Marketable debt securities   42,563    59,962 
Other accounts receivable   705    218 
Total current assets   84,328    90,406 
           
Right of use assets   603    - 
Property and equipment, net   180    194 
Total non-current assets   783    194 
           
Total assets  $85,111   $90,600 
           
Liabilities and stockholders' equity          
           
Current liabilities          
Trade payables  $2,578   $1,814 
Other accounts payable   704    892 
Total current liabilities   3,282    2,706 
           
Non-current liabilities          
Lease obligation  $442   $- 
Total non-current liabilities   442    - 
           
Ordinary shares par value NIS 0.01 per share; Authorized 50,000,000; Issued and outstanding: 21,121,337 shares as of June 30, 2019; 21,018,919 shares as of December 31, 2018   58    58 
Additional paid-in capital   175,424    174,322 
Accumulated other comprehensive gain (loss)   41    (11)
Accumulated deficit   (94,136)   (86,475)
Total stockholders' equity   81,387    87,894 
           
Total liabilities and stockholders' equity  $85,111   $90,600 

  

The accompanying notes are an integral part of the interim consolidated financial statements.

  

  

 

 

GALMED PHARMACEUTICALS LTD.
Consolidated Statements of Operations (Unaudited)
U.S. Dollars in thousands, except share data and per share data

 

  Three months ended
June 30,
   Six months ended
June 30,
 
   2019   2018   2019   2018 
Revenue  $-   $270   $-   $538 
                     
Research and development expenses   3,494    1,940    6,763    3,884 
                     
General and administrative expenses   1,207    1,105    1,978    1,988 
                     
Total operating expenses   4,701    2,775    8,741    5,334 
                     
Financial income, net   532    90    1,080    143 
                     
Net loss  $4,169   $2,685   $7,661   $5,191 
                     
Basic and diluted net loss per share  $0.20   $0.17   $0.36   $0.34 
                     
Weighted-average number of shares outstanding used in computing basic and diluted net loss per share   21,120,085    15,711,736    21,102,306    15,243,785 

  

The accompanying notes are an integral part of the interim consolidated financial statements.

  

   

 

 

GALMED PHARMACEUTICALS LTD.
Consolidated Statements of Comprehensive Loss (Unaudited)
U.S. Dollars in thousands

 

   Three months ended
June 30,
   Six months ended
June 30,
 
   2019   2018   2019   2018 
Net loss  $4,169   $2,685   $7,661   $5,191 
                     
Other comprehensive loss:                    
Net unrealized loss (gain) on available for sale securities   (16)   (7)   (52)   22 
                     
Comprehensive loss  $4,153   $2,678   $7,609   $5,213 

 

The accompanying notes are an integral part of the interim consolidated financial statements.

  

  

 

 

GALMED PHARMACEUTICALS LTD.
Consolidated Statements of Changes in Stockholders’ Equity (Unaudited)
U.S. Dollars in thousands, except share data and per share data

 

   Ordinary shares  Additional
paid-in
   Accumulated
other
Comprehensive
   Accumulated     
   Shares   Amount   capital   loss   Deficit   Total 
Balance - December 31, 2017   14,435,161   $40   $92,381   $(7)  $(76,619)  $15,795 
Stock-based compensation   -    -    330    -    -    330 
Exercise of options and restricted stock units   37,253    (*)    12    -    -    12 
Unrealized loss from marketable debt securities   -    -    -    (29)   -    (29)
Net loss   -    -    -    -    (2,506)   (2,506)
Balance - March 31, 2018   14,472,414   $40   $92,723   $(36)  $(79,125)  $13,602 
Stock-based compensation   -    -    87    -    -    87 
Exercise of options and restricted stock units   291,080    1    867    -    -    868 
Issuance of ordinary shares and warrants   1,000,000    3    5,962              5,965 
Issuance of ordinary shares (Underwriter agreement)   5,000,000    14    70,290              70,304 
Issuance of ordinary shares (ATM offering)   149,260    (*)    2,895    -    -    2,895 
Unrealized gain from marketable debt securities   -    -    -    7    -    7 
Net loss   -    -    -    -    (2,685)   (2,685)
Balance - June 30, 2018   20,912,754   $58   $172,824   $(29)  $(81,810)  $91,043 

 

   Ordinary shares   Additional
paid-in
   Accumulated
other
Comprehensive
   Accumulated     
   Shares   Amount   capital   loss   Deficit   Total 
Balance - December 31, 2018   21,018,919   $58   $174,322   $(11)  $(86,475)  $87,894 
Stock-based compensation   -    -    416    -    -    416 
Exercise of options and restricted stock units   94,147    (*)    74    -    -    74 
Unrealized gain from marketable debt securities   -    -    -    36    -    36 
Net loss   -    -    -    -    (3,492)   (3,492)
Balance - March 31, 2019   21,113,066   $58   $174,812   $25   $(89,967)  $84,928 
Stock-based compensation   -    -    591    -    -    591 
Exercise of options and restricted stock units   8,271    (*)    21    -    -    21 
Unrealized gain from marketable debt securities   -    -    -    16    -    16 
Net loss   -    -    -    -    (4,169)   (4,169)
Balance - June 30, 2019   21,121,337   $58   $175,424   $41   $(94,136)  $81,387 

 

 (*) Less than 1 thousand $.

 

The accompanying notes are an integral part of the interim consolidated financial statements.

 

  

 

 

GALMED PHARMACEUTICALS LTD.
Consolidated Statements of Cash Flows (Unaudited)
U.S. Dollars in thousands

 

   Six months ended
June 30,
 
   2019   2018 
Cash flow from operating activities          
           
Net loss  $(7,661)  $(5,191)
           
Adjustments required to reconcile net loss to net cash used in operating activities          
Depreciation and amortization   18    118 
Stock-based compensation expense   1,007    417 
Interest income from short-term deposits   (215)   - 
           
Amortization of discount on marketable securities   (71)   (4)
Loss (gain) from realization of marketable securities   (9)   5 
Changes in operating assets and liabilities:          
Decrease (increase) in other accounts receivable   (487)   (213)
Increase in trade payables   764    70 
Increase (decrease) in other accounts payable   (349)   424 
Decrease in deferred revenue   -    (538)
Net cash used in operating activities   (7,003)   (4,912)
           
Cash flow from investing activities          
Purchase of property and equipment   (4)   (1)
Investment in available for sale securities   (68,717)   (85,174)
Investment in short-term deposits   (9,000)   - 
Consideration from sale of available for sale securities   86,248    3,173 
Net cash provided in (used in) investing activities   8,527    (82,002)
           
Cash flow from financing activities          
Issuance of ordinary shares and warrants, net of issuance costs   -    79,164 
Proceeds from exercise of options   95    880 
Net cash provided in financing activities   95    80,044 
           
Increase (Decrease) in cash and cash equivalents   1,619    (6,870)
Cash and cash equivalents at the beginning of the period   24,159    13,021 
Cash and cash equivalents at the end of the period  $25,778   $6,151 
           
Supplemental disclosure of cash flow information:          
Cash received from interest  $1,057    171 
           
Non-cash transactions:          
Recognition of right-of-use asset and lease liability from adoption of ASU 2016-02  $679    - 

   

The accompanying notes are an integral part of the interim consolidated financial statements.

  

  

 

 

GALMED PHARMACEUTICALS LTD.
Notes to Consolidated Financial Statements

 

Note 1 - Basis of presentation

 

Galmed Pharmaceuticals Ltd. (the “Company”) is a clinical-stage biopharmaceutical company primarily focused on the development of therapeutics for the treatment of liver diseases. The Company was incorporated in Israel on July 31, 2013 and commenced operations on February 2, 2014. The Company holds a wholly-owned subsidiary, Galmed International Ltd., which was incorporated in Malta. Galmed International Ltd. previously held a wholly-owned subsidiary, Galmed Medical Research Ltd., which was incorporated in Israel, and had been an inactive company since 2015 and was liquidated during the first quarter of 2019. The Company also holds a wholly-owned subsidiary, Galmed Research and Development Ltd., which was incorporated in Israel.

 

These unaudited interim consolidated financial statements have been prepared as of June 30, 2019 and for the three and six months period then ended. Accordingly, certain information and footnote disclosures normally included in annual financial statements prepared in accordance with U.S. GAAP have been omitted. These unaudited interim consolidated financial statements should be read in conjunction with the audited financial statements and the accompanying notes of the Company for the year ended December 31, 2018 that are included in the Company's Annual Report on Form 20-F, filed with the Securities and Exchange Commission on March 13, 2019 (the "Annual Report"). The results of operations presented are not necessarily indicative of the results to be expected for the year ending December 31, 2019.

 

Note 2 - Summary of significant accounting policies

 

The significant accounting policies that have been applied in the preparation of the unaudited consolidated interim financial statements are identical to those that were applied in preparation of the Company’s most recent annual financial statements in connection with its Annual Report on Form 20-F except for the adoption of Accounting Standards Update (‘ASU”) 2016-02.

 

In February 2016, the Financial Accounting Standards Board issued ASU 2016-02, Leases (Topic 842). This ASU requires entities that lease assets to recognize on the balance sheet the assets and liabilities for the rights and obligations created by leases with lease terms of more than 12 months. The Company adopted this ASU effective January 1, 2019 using the modified retrospective application, applying the new standard to leases in place as of the adoption date. Prior periods have not been adjusted.

 

Recently issued accounting pronouncements

 

In May 2019, the FASB issued ASU 2019-05—Financial Instruments—Credit Losses (Topic 326): Targeted Transition Relief. The amendments in ASU No. 2019-05 provide an option to irrevocably elect the fair value option, on an instrument-by-instrument basis, for eligible financial assets measured on an amortized cost basis upon adoption of the credit losses standard. The ASU is effective for the Company beginning on January 1, 2020.

 

Note 3 - Stockholders' Equity

 

1.During the six months ended June 30, 2019, certain employees and consultants exercised options into an aggregate of 96,523 ordinary shares of the Company, NIS 0.01 par value per share, for total consideration of $0.1 million.

 

2.During the six months ended June 30, 2019, restricted stock units held by certain officers and employees vested resulting in the issuance of 5,895 ordinary shares of the Company, NIS 0.01 par value per share.

 

3.In May 2019, the Company granted options to purchase 47,500 ordinary shares of the Company to several employees. The options are exercisable at $7.79 per share, have a 10 year term and vest over a period of four years. The aggregate grant date fair value of such options was approximately $0.3 million.

 

 

 

 

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

 

All references to “we,” “us,” “our,” “the Company” and “our Company”, in this Form 6-K are to Galmed Pharmaceuticals Ltd. and its subsidiaries, unless the context otherwise requires. All references to “shares” or “ordinary shares” are to our ordinary shares, NIS 0.01 nominal par value per share. All references to “Israel” are to the State of Israel. “U.S. GAAP” means the generally accepted accounting principles of the United States. Unless otherwise stated, all of our financial information presented in this Form 6-K has been prepared in accordance with U.S. GAAP. Any discrepancies in any table between totals and sums of the amounts and percentages listed are due to rounding. Unless otherwise indicated, or the context otherwise requires, references in this Form 6-K to financial and operational data for a particular year refer to the fiscal year of our company ended December 31 of that year.

 

Our reporting currency and financial currency is the U.S. dollar. In this Form 6-K, “NIS” means New Israeli Shekel, and “$,” “US$” and “U.S. dollars” mean United States dollars.

 

Cautionary Note Regarding Forward-Looking Statements

 

This Form 6-K contains forward-looking statements about our expectations, beliefs or intentions regarding, among other things, our product development efforts, business, financial condition, results of operations, strategies or prospects. In addition, from time to time, we or our representatives have made or may make forward-looking statements, orally or in writing. Forward-looking statements can be identified by the use of forward-looking words such as “believe,” “expect,” “intend,” “plan,” “may,” “should,” “anticipate,” “could,” “might,” “seek,” “target,” “will,” “project,” “forecast,” “continue” or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. These forward-looking statements may be included in, among other things, various filings made by us with the SEC, press releases or oral statements made by or with the approval of one of our authorized executive officers. Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking statements. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to, the factors summarized below:

 

·the timing and cost of our planned pivotal Phase 3/4 ARMOR trial, or the ARMOR Study, for our product candidate, Aramchol, or whether a pivotal trial will be conducted at all;

 

·completion and receiving favorable results of the ARMOR Study for Aramchol or any other pre-clinical or clinical trial;

 

·regulatory action with respect to Aramchol by the U.S. Food and Drug Administration, or the FDA, or the European Medicines Authority, including but not limited to acceptance of an application for marketing authorization, review and approval of such application, and, if approved, the scope of the approved indication and labeling;

 

·the commercial launch and future sales of Aramchol and any future product candidates;

 

·our ability to comply with all applicable post-market regulatory requirements for Aramchol in the countries in which we seek to market the product;

 

·our ability to achieve favorable pricing for Aramchol;

 

·our expectations regarding the commercial market for non-alcoholic steato-hepatitis, or NASH, in patients;

 

·third-party payor reimbursement for Aramchol;

 

·our estimates regarding anticipated capital requirements and our needs for additional financing;

 

·market adoption of Aramchol by physicians and patients;

 

·the timing, cost or other aspects of the commercial launch of Aramchol;

 

·the development and approval of the use of Aramchol for additional indications or in combination therapy; and

 

·our expectations regarding licensing, acquisitions and strategic operations.

 

 

 

 

We believe these forward-looking statements are reasonable; however, these statements are only current predictions and are subject to known and unknown risks, uncertainties and other factors that may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from those anticipated by the forward-looking statements. We discuss many of these risks in our Annual Report on Form 20-F for the year ended December 31, 2018 filed with the SEC on March 13, 2019 in greater detail under the heading “Risk Factors” and elsewhere in the Annual Report and this Form 6-K. Given these uncertainties, you should not rely upon forward-looking statements as predictions of future events. 

 

All forward-looking statements attributable to us or persons acting on our behalf speak only as of the date hereof and are expressly qualified in their entirety by the cautionary statements included in this report. We undertake no obligations to update or revise forward-looking statements to reflect events or circumstances that arise after the date made or to reflect the occurrence of unanticipated events. In evaluating forward-looking statements, you should consider these risks and uncertainties.

 

Overview

 

We are a clinical-stage biopharmaceutical company focused on the development of Aramchol, a liver targeted stearoyl-coenzyme A desaturase-1, or SCD1, modulator, first in class, novel, oral therapy for the treatment of NASH for variable populations. In June 2018, we announced top line data from our ARREST Phase 2b clinical study, a multicenter, randomized, double blind, placebo-controlled study, designed to evaluate the efficacy and safety of Aramchol in 247 subjects with NASH, who are overweight or obese, and who are pre-diabetic or type-II-diabetic. We are currently focused on preparing for our Phase 3/4 pivotal ARMOR Study which we plan on commencing in the third quarter of 2019. 

 

Financial Overview

 

To date, we have funded our operations primarily through proceeds from private placements and public offerings. At June 30, 2019, we had current assets of $84.3 million, which includes cash and cash equivalents of $25.8 million, short-term deposits of $15.3 million and marketable debt securities of $42.6 million. This compares with current assets of $90.4 million at December 31, 2018, which consisted of cash and cash equivalents of $24.2 million, short-term deposits of $6.1 million and marketable debt securities of $60.0 million. Although we provide no assurance, we believe that such existing funds will be sufficient to continue our business and operations as currently conducted for more than 12 months from the date of issuance of this Form 6-K. However, we will continue to incur operating losses, which may be substantial over the next several years, and we may need to obtain additional funds to further develop our research and development programs.

 

 

 

 

Revenues

 

We have entered into a license agreement with Samil Pharma. Co., Ltd., or the Samil Agreement, for the commercialization of Aramchol in Korea. Under the terms of the Samil Agreement, we have received upfront and milestone payments of $3.6 million, and may be eligible to receive up to approximately $4.5 million in additional payments for development and regulatory milestones for Aramchol in the licensed territories.

 

During 2018, when we determined that the achievement of our first milestone was probable, we included the variable consideration of $1.5 million as a part of the transaction price allocated to the combined performance obligation including the delivery of the license and completion of the ARREST study. We will re-evaluate the transaction price in each reporting period when events whose outcomes are resolved or other changes in circumstances occur that would indicate it is appropriate to recognize variable consideration as revenue.

 

Costs and Operating Expenses

 

Our current costs and operating expenses consist of two components: (i) research and development expenses; and (ii) general and administrative expenses.

 

Research and Development Expenses

 

Our research and development expenses consist primarily of outsourced development expenses, salaries and related personnel expenses and fees paid to external service providers, patent-related legal fees, costs of pre-clinical studies and clinical trials and drug and laboratory supplies. We account for all research and development expenses as they are incurred. We expect our research and development expense to remain our primary expense in the near future as we continue to develop Aramchol. Increases or decreases in research and development expenditures are primarily attributable to the number and/or duration of the pre-clinical and clinical studies that we conduct.

 

We expect that a substantial amount of our research and development expense in the future will be incurred in support of our current and anticipated pre-clinical and clinical development projects. Due to the inherently unpredictable nature of pre-clinical and clinical development studies, we are unable to estimate with any certainty the costs we will incur in the continued development of Aramchol for NASH and other indications in our pipeline for potential partnering and/or commercialization. Clinical development timelines, the probability of success and development costs can differ materially from expectations. We currently expect to continue testing Aramchol in pre-clinical studies for toxicology, safety and efficacy, and to conduct additional clinical trials for Aramchol.

 

While we are currently focused on advancing Aramchol's development, our future research and development expenses will depend on the clinical success of Aramchol, as well as ongoing assessments of Aramchol’s commercial potential. As we obtain results from clinical trials, we may elect to discontinue or delay clinical trials for our product candidate in certain indications in order to focus our resources on more promising indications for such product candidate. Completion of clinical trials may take several years or more, but the length of time generally varies according to the type, complexity, novelty and intended use of a product candidate.

 

We expect our research and development expenses to increase in the future from current levels as we continue to advance our clinical product development and, potentially, the in-licensing of additional product candidates.

 

The lengthy process of completing clinical trials and seeking regulatory approval for Aramchol requires the expenditure of substantial resources. Any failure or delay in completing clinical trials, or in obtaining regulatory approvals, could cause a delay in generating product revenue and cause our research and development expenses to increase and, in turn, have a material adverse effect on our operations. Because of the factors set forth above, we are not able to estimate with any certainty when we would recognize any net cash inflows from our projects. 

 

General and Administrative Expenses

 

General and administrative expenses consist primarily of compensation for employees in executive and operational roles, including finance/accounting, legal and other operating positions in connection with our activities. Our other significant general and administrative expenses include non-cash stock-based compensation costs and facilities costs (including the rental expense for our offices in Tel Aviv, Israel), professional fees for outside accounting and legal services, travel costs, investors relations, insurance premiums and depreciation. 

 

Financial Income, Net

 

Our financial income consists of interest income from marketable securities and our financial expense consists of fees associated with banking activities and losses from realization of marketable securities.

 

 

 

 

Results of Operations

 

The table below provides our results of operations for the three and six months ended June 30, 2019 as compared to the three and six months ended June 30, 2018.

 

   Three months ended June 30,   Six months ended June 30, 
   2019   2018   2019   2018 
   (unaudited)   (unaudited)   (unaudited)   (unaudited) 
   (In thousands, except per share data) 
Revenue   -    270    -    538 
Research and development expenses   3,494    1,940    6,763    3,884 
General and administrative expenses   1,207    1,105    1,978    1,988 
Total operating expenses   4,701    2,775    8,741    5,334 
Financial income, net   532    90    1,080    143 
Net loss   4,169    2,685    7,661    5,191 
Other comprehensive loss (income):   (16)   (7)   (52)   22 
Comprehensive loss   4,153    2,678    7,609    5,213 
Basic and diluted net loss per share  $0.20   $0.17   $0.36   $0.34 

 

Revenue

 

During the three and six months ended June 30, 2019, we had no licensing revenue, as compared to approximately $0.3 million and $0.5 million respectively, for three and six months ended June 30, 2018. The revenue in 2018 resulted from the amortization of the up-front payments under the license agreement with Samil Pharm.

 

Research and Development Expenses

 

Our research and development expenses amounted to approximately $3.5 million and approximately $6.8 million during the three and six months ended June 30, 2019, respectively, representing an increase of approximately $1.6 million, or 84%, and approximately $2.9 million, or 74%, respectively, compared to approximately $1.9 million and approximately $3.9 million for the comparable period in 2018.

 

The increase during the three and six months ended June 30, 2019 primarily resulted from an increase in clinical and pre-clinical studies and drug development expenses in an amount of approximately $1.0 million and $1.9 million, respectively, related to continuing preparations of the ARMOR trial.

 

General and Administrative Expenses

 

Our general and administrative expenses amounted to approximately $1.2 million and approximately $2.0 million during the three and six months ended June 30, 2019, respectively, representing an increase of approximately $0.1 million, or 9% for the three months ended June 30, 2018 and no change for the six months ended June 30, 2018, compared to approximately $1.1 million and approximately $2.0 million for the comparable period in 2018.

 

The increase during the three months ended June 30, 2019 primarily resulted from an increase of approximately $0.2 million in both non-cash stock-based compensation, as compared to such expenses for the comparable period in 2018.

 

 

 

 

Operating Loss

 

As a result of the foregoing, for the three and six months ended June 30, 2019, our operating loss was approximately $4.7 million and approximately $8.7 million, respectively, representing an increase of $1.9 million, or 68%, and an increase of $3.4 million, or 64%, respectively, as compared to approximately $2.8 million and approximately $5.3 million for the comparable period in 2018.

 

Financial Income, Net

 

Our financial income, net amounted to approximately $0.5 million and approximately $1.1 million during the three and six months ended June 30, 2019, respectively, compared to $0.1 million and $0.15 million for the comparable period in 2018.

 

The increase during the three and six months ended June 30, 2019 primarily resulted from an increase in interest income from marketable debt securities and short-term deposits, as compared to such expenses for the comparable period in 2018.

 

Net Loss

 

As a result of the foregoing, for the three and six months ended June 30, 2019 and 2018, our net loss was approximately $4.2 million and approximately $7.7 million, respectively, representing an increase of $1.5 million, or 56%, and an increase of $2.5 million, or 48%, respectively, as compared to approximately $2.7 million and approximately $5.2 million for the comparable period in 2018.

 

 

 

 

Liquidity and Capital Resources

 

To date, we have funded our operations primarily through proceeds from private placements and public offerings.  Under our existing “at the market” equity offering program, or the ATM offering, as of the date hereof, we may sell, from time to time, up to approximately $32.0 million of additional ordinary shares.

 

We have incurred substantial losses since our inception. As of June 30, 2019, we had an accumulated deficit of approximately $94.1 million and positive working capital (current assets less current liabilities) of approximately $81.0 million. We expect that operating losses will continue for the foreseeable future.

 

As of June 30, 2019, we had cash and cash equivalents of approximately $25.8 million, short-term deposits of approximately $15.3 million and marketable securities of approximately $42.6 million invested in accordance with our investment policy, totalling approximately $83.6 million, as compared to approximately $24.2 million, $6.1 million and $60.0 million as of December 31, 2018, totalling approximately $90.2 million. The decrease is mainly attributable to our $7.0 million negative cash flow from operations during the six months ended June 30, 2019.

 

We had negative cash flow from operating activities of approximately $7.0 million for the six months ended June 30, 2019, as compared to negative cash flow from operating activities of approximately $4.9 million for the six months ended June 30, 2018. The negative cash flow from operating activities for the six months ended June 30, 2019 is mainly attributable to our net loss of approximately $7.7 million.

 

We had positive cash flow from investing activities of approximately $8.5 million for the six months ended June 30, 2019, as compared to negative cash flow from investing activities of approximately $82.0 million for the six months ended June 30, 2018. The positive cash flow from investing activities for the six months ended June 30, 2019 was primarily due to the net investment of marketable securities, partially offset by an investment in short-term deposits.

 

We had positive cash flow from financing activities of approximately $0.1 million for the six months ended June 30, 2019, as compared to positive cash flow from financing activities of approximately $80.0 million for the six months ended June 30, 2018. The positive cash flow from financing activities for the six months ended June 30, 2019 was due to the proceeds from exercise of options.

 

Although there can be no assurance, we believe that our existing cash resources will be sufficient to fund our projected cash requirements for more than 12 months from the date of issuance of this Form 6-K.

 

Our future capital requirements will depend on many other factors, including: 

 

·the progress and costs of our pre-clinical studies, clinical trials and other research and development activities;

 

·the scope, prioritization and number of our clinical trials and other research and development programs;

 

·the amount of revenues and contributions we receive under future licensing, development and commercialization arrangements with respect to Aramchol;

 

·the costs of the development and expansion of our operational infrastructure;

 

·the costs and timing of obtaining regulatory approval for Aramchol;

 

·the ability of us, or our collaborators, to achieve development milestones, marketing approval and other events or developments under our potential future licensing agreements;

 

·the costs of filing, prosecuting, enforcing and defending patent claims and other intellectual property rights;

 

·the costs and timing of securing manufacturing arrangements for clinical or commercial production;

 

·the costs of contracting with third parties to provide sales and marketing capabilities for us;

 

·the costs of acquiring or undertaking development and commercialization efforts for any future products, product candidates or platforms;

 

·the magnitude of our general and administrative expenses; and

 

·any cost that we may incur under future in- and out-licensing arrangements relating to Aramchol.

 

 

 

 

Until we can generate significant recurring revenues, we expect to satisfy our future cash needs through the net proceeds from equity financings (such as the ATM Offering) or by out-licensing applications of Aramchol. We cannot be certain that additional funding will be available to us on acceptable terms, if at all. If funds are not available, we may be required to delay, reduce the scope of or eliminate research or development plans for, or commercialization efforts with respect to, one or more applications of Aramchol. This may raise substantial doubts about the Company’s ability to continue as a going concern.

 

Trend Information

 

We are a development stage company, and it is not possible for us to predict with any degree of accuracy the outcome of our research, development or commercialization efforts. As such, it is not possible for us to predict with any degree of accuracy any significant trends, uncertainties, demands, commitments or events that are reasonably likely to have a material effect on our net sales or revenues, income from continuing operations, profitability, liquidity or capital resources, or that would cause financial information to not necessarily be indicative of future operating results or financial condition. However, to the extent possible, certain trends, uncertainties, demands, commitments and events are in this “Management’s Discussion and Analysis of Financial Condition and Results of Operations”.

 

Controls and Procedures

 

As a “foreign private issuer”, we are only required to conduct the evaluations required by Rules 13a-15(b) and 13a-15(d) of the Exchange Act as of the end of each fiscal year and therefore have elected not to provide disclosure regarding such evaluations at this time.

 

 

 

 

EXHIBIT INDEX

 

Exhibit No.   Description
     
99.1   Press Release, dated August 5, 2019
     
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 Document

 

 

 

 

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.

 

  Galmed Pharmaceuticals Ltd.
     
Date:  August 5, 2019 By:   /s/ Allen Baharaff
    Allen Baharaff
    President and Chief Executive Officer

 

 

 

Exhibit 99.1

 

 

 

Galmed Pharmaceuticals Provides Business Update and Reports Second Quarter 2019 Financial Results

 

- Conference Call and Webcast Today at 8:30 a.m. EST / 5:30 a.m. PST -

 

TEL AVIV, Israel, August 5, 2019 - Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) (“Galmed” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of the liver targeted SCD1 modulator Aramchol, a once-daily, oral therapy for the treatment of nonalcoholic steatohepatitis, or NASH, today provides business update and reports financial results for the three and six months ended June 30, 2019. The Company will host a conference call and webcast at 08:30 ET today.

 

Financial Summary - Second Quarter 2019 vs. Second Quarter 2018:

 

  · Cash and cash equivalents, short-term deposits and marketable securities totaled $83.6 million as of June 30, 2019, compared to $90.2 million at December 31, 2018.

 

  · Net loss of $4.2 million, or ($0.20) per share, for the three months ended June 30, 2019, compared to a net loss of $2.7 million, or ($0.17) per share, for the three months ended June 30, 2018.

 

  · Research and development expenses amounted to approximately $3.5 million for the three months ended June 30, 2019, compared to approximately $1.9 million for the three months ended June 30, 2018. The increase resulted primarily from an increase in clinical and pre-clinical trial expenses.

 

  · General and administrative expenses amounted to approximately $1.2 million for the three months ended June 30, 2019, compared to approximately $1.1 million for the three months ended June 30, 2018.

 

  · Financial expenses amounted to $0.5 million for the three months ended June 30, 2019, compared to financial income of $0.1 million for the three months ended June 30, 2018. The increase primarily relates to an increase in financial income from financial assets.

 

 

 

 

 

Conference Call & Webcast:

Monday, August 5th @ 8:30am Eastern Time.

Toll Free:1-877-425-9470

Toll/International:1-201-389-0878

Israel Toll Free:1-809-406-247

Conference ID:13692794

Webcast:http://public.viavid.com/index.php?id=135464

 

Replay Dial-In Numbers

Toll Free:1-844-512-2921
Toll/International:1-412-317-6671
Replay Pin Number:13692794
Replay Start:Monday August 5, 2019, 11:30 AM ET
Replay Expiry:Monday August 19, 2019, 11:59 PM ET

 

About Aramchol and Non-alcoholic Steatohepatitis (NASH)

Aramchol (arachidyl amido cholanoic acid) is a novel fatty acid bile acid conjugate, inducing beneficial modulation of intra-hepatic lipid metabolism. Aramchol's ability to modulate hepatic lipid metabolism was discovered and validated in animal models, demonstrating downregulation of the three key pathologies of NASH: steatosis, inflammation and fibrosis. The effect of Aramchol on fibrosis is mediated by downregulation of steatosis and directly on human collagen producing cells. Aramchol has been granted Fast Track designation status by the FDA for the treatment of NASH.

 

NASH is an emerging world crisis impacting an estimated 3% to 5% of the U.S. population and an estimated 2% to 4% globally. It is the fastest growing cause of liver cancer and liver transplant in the U.S. due to the rise in obesity. NASH is the progressive form of non-alcoholic fatty liver disease that can lead to cardiovascular disease, cirrhosis and liver-related mortality.

  

About Galmed Pharmaceuticals Ltd.

Galmed is a clinical-stage biopharmaceutical company focused on the development of Aramchol, a first in class, novel, once-daily, oral therapy for the treatment of NASH for variable populations. During 2018, Galmed rannounced top-line results of the ARREST Study, a multicenter, randomized, double blind, placebo-controlled Phase IIb clinical study designed to evaluate the efficacy and safety of Aramchol in subjects with NASH, who are overweight or obese, and who are pre-diabetic or type-II-diabetic. Galmed is currently preparing to initiate a Phase 3/4 clinical study in the third quarter of 2019. 

 

Forward-Looking Statements:

This press release may include forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to Galmed's objectives, plans and strategies, as well as statements, other than historical facts, that address activities, events or developments that Galmed intends, expects, projects, believes or anticipates will or may occur in the future. These statements are often characterized by terminology such as "believes," "hopes," "may," "anticipates," "should," "intends," "plans," "will," "expects," "estimates," "projects," "positioned," "strategy" and similar expressions and are based on assumptions and assessments made in light of management's experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Many factors could cause Galmed's actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to, the following: the timing and cost of Galmed's planned pivotal Phase 3/4 ARMOR trial, or the ARMOR Study or whether a pivotal trial will be conducted at all; completion and receiving favorable results of the ARMOR Study for Aramchol or any other pre-clinical or clinical trial; regulatory action with respect to Aramchol by the FDA or the EMA; the commercial launch and future sales of Aramchol or any other future products or product candidates; Galmed's ability to comply with all applicable post-market regulatory requirements for Aramchol in the countries in which it seeks to market the product; Galmed's ability to achieve favorable pricing for Aramchol; Galmed's expectations regarding the commercial market for NASH patients; third-party payor reimbursement for Aramchol; Galmed's estimates regarding anticipated capital requirements and Galmed's needs for additional financing; market adoption of Aramchol by physicians and patients; the timing, cost or other aspects of the commercial launch of Aramchol; the development and approval of the use of Aramchol for additional indications or in combination therapy; and Galmed's expectations regarding licensing, acquisitions and strategic operations. More detailed information about the risks and uncertainties affecting Galmed is contained under the heading "Risk Factors" included in Galmed's most recent Annual Report on Form 20-F filed with the SEC on March 13, 2019, and in other filings that Galmed has made and may make with the SEC in the future. The forward-looking statements contained in this press release are made as of the date of this press release and reflect Galmed's current views with respect to future events, and Galmed does not undertake and specifically disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.  

 

   

 

 

CONTACT:

Guy Nehemya, Chief Operating Officer

Galmed Pharmaceuticals Ltd.

Guy@galmedpharma.com

 

 

   

 

 

  

GALMED PHARMACEUTICALS LTD.
Consolidated Balance Sheets
U.S. Dollars in thousands, except share data and per share data

 

  

As of

June 30,

2019

  

As of

December 31,

2018

 
   Unaudited   Audited 
Assets          
Current assets          
Cash and cash equivalents  $25,778   $24,159 
Short-term deposits   15,282    6,067 
Marketable debt securities   42,563    59,962 
Other accounts receivable   705    218 
Total current assets   84,328    90,406 
           
Right of use assets   603    - 
Property and equipment, net   180    194 
Total non-current assets   783    194 
           
Total assets  $85,111   $90,600 
           
Liabilities and stockholders' equity          
           
Current liabilities          
Trade payables  $2,578   $1,814 
Other accounts payable   704    892 
Total current liabilities   3,282    2,706 
           
Non-current liabilities          
Lease obligation  $442   $- 
Total non-current liabilities   442    - 
           
Ordinary shares par value NIS 0.01 per share; Authorized 50,000,000; Issued and outstanding: 21,121,337 shares as of June 30, 2019; 21,018,919 shares as of December 31, 2018   58    58 
Additional paid-in capital   175,424    174,322 
Accumulated other comprehensive gain (loss)   41    (11)
Accumulated deficit   (94,136)   (86,475)
Total stockholders' equity   81,387    87,894 
           
Total liabilities and stockholders' equity  $85,111   $90,600 

 

 

 

   

 

 

  

GALMED PHARMACEUTICALS LTD.
Consolidated Statements of Operations (Unaudited)
U.S. Dollars in thousands, except share data and per share data

 

   Three months ended
June 30,
   Six months ended
June 30,
 
   2019   2018   2019   2018 
Revenue  $-   $270   $-   $538 
                     
Research and development expenses   3,494    1,940    6,763    3,884 
                     
General and administrative expenses   1,207    1,105    1,978    1,988 
                     
Total operating expenses   4,701    2,775    8,741    5,334 
                     
Financial income, net   532    90    1,080    143 
                     
Net loss  $4,169   $2,685   $7,661   $5,191 
                     
Basic and diluted net loss per share  $0.20   $0.17   $0.36   $0.34 
                     
Weighted-average number of shares outstanding used in computing basic and diluted net loss per share   21,120,085    15,711,736    21,102,306    15,243,785 

 

 

 

   

 

 

 

 

GALMED PHARMACEUTICALS LTD.
Consolidated Statements of Cash Flows (Unaudited)
U.S. Dollars in thousands

 

   Six months ended
June 30,
 
   2019   2018 
Cash flow from operating activities          
           
Net loss  $(7,661)  $(5,191)
           
Adjustments required to reconcile net loss to net cash used in operating activities          
Depreciation and amortization   18    118 
Stock-based compensation expense   1,007    417 
Interest income from short-term deposits   (215)   - 
           
Amortization of discount on marketable securities   (71)   (4)
Loss (gain) from realization of marketable securities   (9)   5 
Changes in operating assets and liabilities:          
Decrease (increase) in other accounts receivable   (487)   (213)
Increase in trade payables   764    70 
Increase (decrease) in other accounts payable   (349)   424 
Decrease in deferred revenue   -    (538)
Net cash used in operating activities   (7,003)   (4,912)
           
Cash flow from investing activities          
Purchase of property and equipment   (4)   (1)
Investment in available for sale securities   (68,717)   (85,174)
Investment in short-term deposits   (9,000)   - 
Consideration from sale of available for sale securities   86,248    3,173 
Net cash provided in (used in) investing activities   8,527    (82,002)
           
Cash flow from financing activities          
Issuance of ordinary shares and warrants, net of issuance costs   -    79,164 
Proceeds from exercise of options   95    880 
Net cash provided in financing activities   95    80,044 
           
Increase (Decrease) in cash and cash equivalents   1,619    (6,870)
Cash and cash equivalents at the beginning of the period   24,159    13,021 
Cash and cash equivalents at the end of the period  $25,778   $6,151 
           
Supplemental disclosure of cash flow information:          
Cash received from interest  $1,057    171 

 

 

   

 

v3.19.2
Document and Entity Information
6 Months Ended
Jun. 30, 2019
Document and Entity Information [Abstract]  
Document Type 6-K
Amendment Flag false
Document Period End Date Jun. 30, 2019
Document Fiscal Year Focus 2019
Document Fiscal Period Focus Q2
Entity Registrant Name Galmed Pharmaceuticals Ltd.
Entity Central Index Key 0001595353
Current Fiscal Year End Date --12-31
v3.19.2
Consolidated Balance Sheets - USD ($)
$ in Thousands
Jun. 30, 2019
Dec. 31, 2018
Current assets    
Cash and cash equivalents $ 25,778 $ 24,159
Short-term deposits 15,282 6,067
Marketable debt securities 42,563 59,962
Other accounts receivable 705 218
Total current assets 84,328 90,406
Right of use assets 603 0
Property and equipment, net 180 194
Total non-current assets 783 194
Total assets 85,111 90,600
Current liabilities    
Trade payables 2,578 1,814
Other accounts payable 704 892
Total current liabilities 3,282 2,706
Non-current liabilities    
Lease obligation 442 0
Total non-current liabilities 442 0
Ordinary shares par value NIS 0.01 per share; Authorized 50,000,000; Issued and outstanding: 21,121,337 shares as of June 30, 2019; 21,018,919 shares as of December 31, 2018 58 58
Additional paid-in capital 175,424 174,322
Accumulated other comprehensive gain (loss) 41 (11)
Accumulated deficit (94,136) (86,475)
Total stockholders' equity 81,387 87,894
Total liabilities and stockholders' equity $ 85,111 $ 90,600
v3.19.2
Consolidated Balance Sheets (Parenthetical) - ₪ / shares
Jun. 30, 2019
Dec. 31, 2018
Ordinary shares, Par or Stated Value Per Share ₪ 0.01 ₪ 0.01
Ordinary shares, Shares Authorized 50,000,000 50,000,000
Ordinary shares, Shares, Issued 21,121,337 21,018,919
Ordinary shares, Shares, Outstanding 21,121,337 21,018,919
v3.19.2
Consolidated Statements of Operations - USD ($)
$ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2019
Jun. 30, 2018
Jun. 30, 2019
Jun. 30, 2018
Revenue $ 0 $ 270 $ 0 $ 538
Research and development expenses 3,494 1,940 6,763 3,884
General and administrative expenses 1,207 1,105 1,978 1,988
Total operating expenses 4,701 2,775 8,741 5,334
Financial income, net 532 90 1,080 143
Net loss $ 4,169 $ 2,685 $ 7,661 $ 5,191
Basic and diluted net loss per share $ 0.20 $ 0.17 $ 0.36 $ 0.34
Weighted-average number of shares outstanding used in computing basic and diluted net loss per share 21,120,085 15,711,736 21,102,306 15,243,785
v3.19.2
Consolidated Statements of Comprehensive Loss - USD ($)
$ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2019
Jun. 30, 2018
Jun. 30, 2019
Jun. 30, 2018
Net loss $ 4,169 $ 2,685 $ 7,661 $ 5,191
Other comprehensive loss:        
Net unrealized loss (gain) on available for sale securities (16) (7) (52) 22
Comprehensive loss $ 4,153 $ 2,678 $ 7,609 $ 5,213
v3.19.2
Consolidated Statements of Changes in Stockholders' Equity - USD ($)
$ in Thousands
Total
Ordinary shares [Member]
Additional paid-in capital [Member]
Accumulated other Comprehensive loss [Member]
Accumulated deficit [Member]
Balance at Dec. 31, 2017 $ 15,795 $ 40 $ 92,381 $ (7) $ (76,619)
Balance (in shares) at Dec. 31, 2017   14,435,161      
Stock-based compensation 330 $ 0 330 0 0
Exercise of options and restricted stock units 12 [1] 12 0 0
Exercise of options and restricted stock units (in shares)   37,253      
Unrealized gain (loss) from marketable debt securities (29) $ 0 0 (29) 0
Net loss (2,506) 0 0 0 (2,506)
Balance at Mar. 31, 2018 13,602 $ 40 92,723 (36) (79,125)
Balance (in shares) at Mar. 31, 2018   14,472,414      
Balance at Dec. 31, 2017 15,795 $ 40 92,381 (7) (76,619)
Balance (in shares) at Dec. 31, 2017   14,435,161      
Unrealized gain (loss) from marketable debt securities (22)        
Net loss (5,191)        
Balance at Jun. 30, 2018 91,043 $ 58 172,824 (29) (81,810)
Balance (in shares) at Jun. 30, 2018   20,912,754      
Balance at Mar. 31, 2018 13,602 $ 40 92,723 (36) (79,125)
Balance (in shares) at Mar. 31, 2018   14,472,414      
Stock-based compensation 87 $ 0 87 0 0
Exercise of options and restricted stock units 868 $ 1 867 0 0
Exercise of options and restricted stock units (in shares)   291,080      
Issuance of ordinary shares and warrants 5,965 $ 3 5,962    
Issuance of ordinary shares and warrants (in shares)   1,000,000      
Issuance of ordinary shares (Underwriter agreement) 70,304 $ 14 70,290    
Issuance of ordinary shares (Underwriter agreement) (in shares)   5,000,000      
Issuance of ordinary shares (ATM offering) 2,895 [1] 2,895 0 0
Issuance of ordinary shares (ATM offering) (in shares)   149,260      
Unrealized gain (loss) from marketable debt securities 7 $ 0 0 7 0
Net loss (2,685) 0 0 0 (2,685)
Balance at Jun. 30, 2018 91,043 $ 58 172,824 (29) (81,810)
Balance (in shares) at Jun. 30, 2018   20,912,754      
Balance at Dec. 31, 2018 87,894 $ 58 174,322 (11) (86,475)
Balance (in shares) at Dec. 31, 2018   21,018,919      
Stock-based compensation 416 $ 0 416 0 0
Exercise of options and restricted stock units 74 [1] 74 0 0
Exercise of options and restricted stock units (in shares)   94,147      
Unrealized gain (loss) from marketable debt securities 36 $ 0 0 36 0
Net loss (3,492) 0 0 0 (3,492)
Balance at Mar. 31, 2019 84,928 $ 58 174,812 25 (89,967)
Balance (in shares) at Mar. 31, 2019   21,113,066      
Balance at Dec. 31, 2018 $ 87,894 $ 58 174,322 (11) (86,475)
Balance (in shares) at Dec. 31, 2018   21,018,919      
Exercise of options and restricted stock units [1]        
Exercise of options and restricted stock units (in shares) 5,895        
Unrealized gain (loss) from marketable debt securities $ 52        
Net loss (7,661)        
Balance at Jun. 30, 2019 81,387 $ 58 175,424 41 (94,136)
Balance (in shares) at Jun. 30, 2019   21,121,337      
Balance at Mar. 31, 2019 84,928 $ 58 174,812 25 (89,967)
Balance (in shares) at Mar. 31, 2019   21,113,066      
Stock-based compensation 591 $ 0 591 0 0
Exercise of options and restricted stock units 21   21 0 0
Exercise of options and restricted stock units (in shares)   8,271      
Unrealized gain (loss) from marketable debt securities 16 $ 0 0 16 0
Net loss (4,169) 0 0 0 (4,169)
Balance at Jun. 30, 2019 $ 81,387 $ 58 $ 175,424 $ 41 $ (94,136)
Balance (in shares) at Jun. 30, 2019   21,121,337      
[1] Less than 1 thousand $.
v3.19.2
Consolidated Statements of Cash Flows - USD ($)
$ in Thousands
6 Months Ended
Jun. 30, 2019
Jun. 30, 2018
Cash flow from operating activities    
Net loss $ (7,661) $ (5,191)
Adjustments required to reconcile net loss to net cash used in operating activities    
Depreciation and amortization 18 118
Stock-based compensation expense 1,007 417
Interest income from short-term deposits (215) 0
Amortization of discount on marketable securities (71) (4)
Loss (gain) from realization of marketable securities (9) 5
Changes in operating assets and liabilities:    
Decrease (increase) in other accounts receivable (487) (213)
Increase in trade payables 764 70
Increase (decrease) in other accounts payable (349) 424
Decrease in deferred revenue 0 (538)
Net cash used in operating activities (7,003) (4,912)
Cash flow from investing activities    
Purchase of property and equipment (4) (1)
Investment in available for sale securities (68,717) (85,174)
Investment in short-term deposits (9,000) 0
Consideration from sale of available for sale securities 86,248 3,173
Net cash provided in (used in) investing activities 8,527 (82,002)
Cash flow from financing activities    
Issuance of ordinary shares and warrants, net of issuance costs 0 79,164
Proceeds from exercise of options 95 880
Net cash provided in financing activities 95 80,044
Increase (Decrease) in cash and cash equivalents 1,619 (6,870)
Cash and cash equivalents at the beginning of the period 24,159 13,021
Cash and cash equivalents at the end of the period 25,778 6,151
Supplemental disclosure of cash flow information:    
Cash received from interest 1,057 171
Non-cash transactions:    
Recognition of right-of-use asset and lease liability from adoption of ASU 2016-02 $ 679 $ 0
v3.19.2
Basis of presentation
6 Months Ended
Jun. 30, 2019
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
Organization, Consolidation and Presentation of Financial Statements Disclosure [Text Block]
Note 1 - Basis of presentation
 
Galmed Pharmaceuticals Ltd. (the “Company”) is a clinical-stage biopharmaceutical company primarily focused on the development of therapeutics for the treatment of liver diseases. The Company was incorporated in Israel on July 31, 2013 and commenced operations on February 2, 2014. The Company holds a wholly-owned subsidiary, Galmed International Ltd., which was incorporated in Malta. Galmed International Ltd. previously held a wholly-owned subsidiary, Galmed Medical Research Ltd., which was incorporated in Israel, and had been an inactive company since 2015 and was liquidated during the first quarter of 2019. The Company also holds a wholly-owned subsidiary, Galmed Research and Development Ltd., which was incorporated in Israel.
 
These unaudited interim consolidated financial statements have been prepared as of June 30, 2019 and for the three and six months period then ended. Accordingly, certain information and footnote disclosures normally included in annual financial statements prepared in accordance with U.S. GAAP have been omitted. These unaudited interim consolidated financial statements should be read in conjunction with the audited financial statements and the accompanying notes of the Company for the year ended December 31, 2018 that are included in the Company's Annual Report on Form 20-F, filed with the Securities and Exchange Commission on March 13, 2019 (the "Annual Report"). The results of operations presented are not necessarily indicative of the results to be expected for the year ending December 31, 2019.
v3.19.2
Summary of significant accounting policies
6 Months Ended
Jun. 30, 2019
Accounting Policies [Abstract]  
Significant Accounting Policies [Text Block]
Note 2 - Summary of significant accounting policies
 
The significant accounting policies that have been applied in the preparation of the unaudited consolidated interim financial statements are identical to those that were applied in preparation of the Company’s most recent annual financial statements in connection with its Annual Report on Form 20-F except for the adoption of Accounting Standards Update (‘ASU”) 2016-02.
 
In February 2016, the Financial Accounting Standards Board issued ASU 2016-02
,
 
Leases (Topic 842)
. This ASU requires entities that lease assets to recognize on the balance sheet the assets and liabilities for the rights and obligations created by leases with lease terms of more than 12 months. The Company adopted this ASU effective January 1, 2019 using the modified retrospective application, applying the new standard to leases in place as of the adoption date. Prior periods have not been adjusted.
 
Recently issued accounting pronouncements
 
In May 2019, the FASB issued ASU 2019-05—Financial Instruments—Credit Losses (Topic 326): Targeted Transition Relief. The amendments in ASU No. 2019-05 provide an option to irrevocably elect the fair value option, on an instrument-by-instrument basis, for eligible financial assets measured on an amortized cost basis upon adoption of the credit losses standard. The ASU is effective for the Company beginning on January 1, 2020.
v3.19.2
Stockholders' Equity
6 Months Ended
Jun. 30, 2019
Disclosure of Compensation Related Costs, Share-based Payments [Abstract]  
Shareholders' Equity and Share-based Payments [Text Block]
Note 3 - Stockholders' Equity
 
 
1.
During the six months ended June 30, 2019, certain employees and consultants exercised options into an aggregate of 96,523 ordinary shares of the Company, NIS 0.01 par value per share, for total consideration of $0.1 million.
 
 
2.
During the six months ended June 30, 2019, restricted stock units held by certain officers and employees vested resulting in the issuance of 5,895 ordinary shares of the Company, NIS 0.01 par value per share.
 
 
3.
In May 2019, the Company granted options to purchase 47,500 ordinary shares of the Company to several employees. The options are exercisable at $7.79 per share, have a 10 year term and vest over a period of four years. The aggregate grant date fair value of such options was approximately $0.3 million.
v3.19.2
Basis of presentation (Details Textual)
6 Months Ended
Jun. 30, 2019
General [Line Items]  
Entity Incorporation, Date of Incorporation Jul. 31, 2013
Operations Commenced Date Feb. 02, 2014
Entity Incorporation, State Country Name Israel
v3.19.2
Stockholders' Equity (Details Textual)
$ / shares in Units, $ in Millions
1 Months Ended 6 Months Ended
May 31, 2019
USD ($)
$ / shares
shares
Jun. 30, 2019
USD ($)
shares
Jun. 30, 2019
₪ / shares
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]      
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross 47,500    
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Remaining Contractual Term 10 years    
Shares Issued, Price Per Share | ₪ / shares     ₪ 0.01
Stock Issued During Period, Shares, Restricted Stock Award, Gross   5,895  
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period   96,523  
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Aggregate Intrinsic Value, Vested | $ $ 0.3    
Share-based Compensation Arrangements by Share-based Payment Award, Options, Exercises in Period, Weighted Average Exercise Price | $ / shares $ 7.79    
Stock Issued During Period, Value, Stock Options Exercised | $   $ 0.1  
Share-based Compensation Arrangement by Share-based Payment Award, Expiration Period 4 years