Washington, D.C. 20549




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

Under the Securities Exchange Act of 1934


For the Month of March 2020



(Commission File Number)



(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): ____






Attached hereto and incorporated herein by reference is a press release, dated March 12, 2020, and entitled “Galmed Pharmaceuticals Reports Fourth Quarter and Full Year 2019 Financial Results and Provides Business Update.”


On March 11, 2020, the board of directors of Galmed Pharmaceuticals Ltd. (the “Company”) resolved to adopt an exemption available under Israeli law, pursuant to which a public company with no controlling shareholder whose securities are listed on certain foreign exchanges (including the Nasdaq Capital Market) and which satisfies the applicable foreign country's laws and regulations that apply to companies organized in that country relating to the appointment of independent directors and the composition of audit and compensation committees, is exempt from the requirement to appoint external directors or comply with the audit committee and compensation committee composition requirements under the Israeli Companies Law – 1999 (the “Companies Law”). The Company complies with the Nasdaq Listing Rules (i) requiring a majority of independent directors on the board of directors and (ii) relating to the composition of each of the audit committee and the compensation committee, in lieu of such requirements of the Companies Law. Effective as of March 11, 2020 and following the Company’s adoption of the foregoing exemption, the Company’s external directors, Ms. Tali Yaron-Eldar and Mr. David Sidransky are no longer classified as such. Certain transition rules provide that such directors have the right to remain board members until the earlier of the end of term of such directors (which for both Ms. Yaron-Eldar and Mr. Sidransky is in June 2020) or the second annual meeting of shareholders after adoption of the exemption.


This Form 6-K is incorporated by reference into the Company’s Registration Statements 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).








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:  March 12, 2020 By: /s/ Allen Baharaff  
    Allen Baharaff
    President and Chief Executive Officer














Exhibit 99.1




Galmed Pharmaceuticals Provides Business Update and Reports Fourth Quarter and Year End 2019 Financial Results


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


TEL AVIV, Israel, March 12, 2020 - Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of Aramchol, a liver targeted, oral, SCD1 modulator, currently in a Phase 3 clinical trial for the treatment of nonalcoholic steatohepatitis (NASH) and fibrosis provides today a business update and reports financial results for the three and twelve months ended December 31, 2019. The Company will host a conference call and webcast at 08:30 ET today.


Financial Summary – Full Year 2019 vs. Full Year 2018; 4Q19vs. 4Q18:


·For the three and twelve months ended December 31, 2019, the Company recorded a net loss of $8.3 and $20.5 million or $0.39 and $0.97 per share, respectively, compared with a net loss of $3.7 million and $9.9 million, or $0.18 and $0.54 per share, for the three and twelve months ended December 31, 2018.


·Research and development expenses were $18.2 million for the twelve months ended December 31, 2019, compared with $8.3 million for the twelve months ended December 31, 2018. For the three months ended December 31, 2019, research and development expenses totaled $7.4 million, which compares with $2.7 million for the same period in 2018. The increase during the three and twelve months is mainly due to the preparation and initiation of the ARMOR study.


·The Company incurred general and administrative expenses of $4.2 million for the twelve months ended December 31, 2019, compared with $4.4 million for the twelve months ended December 31, 2018. For the three months ended December 31, 2018, general and administrative expenses totaled $1.3 million, which compares with $1.5 million for the same period in 2018. The decrease primarily resulted from a decrease in salaries and benefits expenses of approximately $0.5 million due to lower year-end bonuses.


·During the three and twelve months ended December 31, 2019, the Company recognized a net financial income of $0.3 million and $1.9 million, respectively, compared with $0.5 and $0.9 million, respectively, during 2018. The increase during the twelve months ended December 31, 2019 is mainly due to an increase in interest income from marketable debt securities and short-term deposits, as compared to such income in 2018.


·Cash and cash equivalents, restricted cash, short-term deposits and marketable debt securities totaled $75.6 million as of December 31, 2019, compared with $90.2 million as of December 31, 2018. The decrease is mainly attributable to our $14.9 million negative cash flow from operations during the twelve months ended December 31, 2019.





Conference Call & Webcast:

Thursday, March 12th @ 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: 13699345
  Webcast: http://public.viavid.com/index.php?id=138184


Replay Dial-In Numbers

  Toll Free: 1-844-512-2921
  Toll/International: 1-412-317-6671
  Replay Pin Number: 13699345 
  Replay Start: Thursday, March 12, 2020, 11:30 AM ET
  Replay Expiry: Thursday, March 26, 2020, 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 Pharmaceuticals Ltd. is a clinical stage drug development biopharmaceutical company for liver, metabolic and inflammatory diseases. Our lead compound, Aramchol™, a backbone drug candidate for the treatment of NASH and fibrosis is currently in a Phase 3 registrational study.


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 pivotal Phase 3 ARMOR trial, or the ARMOR Study; 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 12, 2020, 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.  




Guy Nehemya, Chief Operating Officer

Galmed Pharmaceuticals Ltd.








Consolidated Balance Sheets (Audited)


U.S. Dollars in thousands, except share data and per share data



          As of December 31,  
          2019     2018  
Current assets                        
Cash and cash equivalents           $ 15,931     $ 24,159  
Restricted cash             112       -  
Short-term deposits             27,938       6,067  
Marketable debt securities             31,622       59,962  
Other accounts receivable             827       218  
Total current assets             76,430       90,406  
Right of use assets             538       -  
Property and equipment, net             171       194  
Total non-current assets             709       194  
Total assets           $ 77,139     $ 90,600  
Liabilities and stockholders’ equity                        
Current liabilities                        
Trade payables           $ 5,999     $ 1,814  
Other accounts payable             935       892  
Total current liabilities             6,934       2,706  
Non-current liabilities                        
Lease obligation           $ 352     $ -  
Total non-current liabilities             352       -  
Stockholders’ equity                        
Ordinary shares, par value NIS 0.01 per share; Authorized 50,000,000 shares; Issued and outstanding: 21,139,385 shares as of December 31, 2019; 21,018,919 shares as of December 31, 2018             58       58  
Additional paid-in capital             176,696       174,322  
Accumulated other comprehensive income (loss)             35       (11 )
Accumulated deficit             (106,936 )     (86,475 )
Total stockholders’ equity             69,853       87,894  
Total liabilities and stockholders’ equity           $ 77,139     $ 90,600  






Consolidated Statements of Operations (Audited)


U.S. Dollars in thousands, except share data and per share data


          Year ended December 31,  
          2019     2018     2017  
Revenue           $ -     $ 2,038     $ 1,085  
Research and development expenses             18,180       8,313       9,650  
General and administrative expenses             4,196       4,440       3,799  
Total operating loss             22,376       10,715       12,364  
Financial income, net             (1,915 )     (934 )     (65 )
Loss before income taxes             20,461       9,781       12,299  
Income taxes             -       75       -  
Net loss           $ 20,461     $ 9,856     $ 12,299  
Basic and diluted net loss per share           $ 0.97     $ 0.54     $ 0.98  
Weighted-average number of shares outstanding used in computing basic and diluted net loss per share             21,114,399       18,137,689       12,487,349  







Consolidated Statements of Cash Flows (Audited)


U.S. Dollars in thousands  


   Year ended December 31, 
   2019   2018   2017 
Cash flow from operating activities               
Net loss for the year  $(20,461)  $(9,856)  $(12,299)
Adjustments required to reconcile net loss to net cash used in operating activities:               
Depreciation and amortization   35    387    239 
Amortization of discount/premium on marketable debt securities   (105)   (144)   21 
Loss (gain) on sale of marketable debt securities   (9)   12    143 
Linked difference of marketable debt securities   -    -    (167)
Interest income from short-term deposits   (63)   -    - 
Stock-based compensation expense   2,231    1,783    1,394 
Changes in operating assets and liabilities:               
Decrease in deferred revenue from collaboration agreement   -    (538)   (1,085)
Decrease (increase) in other accounts receivable   (609)   (63)   129 
Increase (decrease) in trade payables   4,185    (462)   (846)
Increase (decrease)  in other accounts payable   (141)   (142)   671 
Increase (decrease) in related party   -    -    (267)
Net cash used in operating activities   (14,937)   (9,023)   (12,067)
Cash flow from investing activities               
Purchase of property and equipment   (12)   (90)   (12)
Investment in securities, available for sale   (72,600)   (92,279)   (3,869)
Proceeds from sale of securities, available for sale   101,098    38,421    10,325 
Investment in short-term deposits, net   (21,808)   (6,067)    
Net cash provided by (used in) investing activities   6,678    (60,015)   6,444 
Cash flow from financing activities               
Issuance of ordinary shares and warrants, net of issuance costs (*)   -    79,149    15,017 
Proceeds from exercise of options   143    1,027    530 
Net cash provided by financing activities   143    80,176    15,547 
Increase (decrease) in cash and cash equivalents and restricted cash   (8,116)   11,138    9,924 
Cash and cash equivalents and restricted cash at the beginning of the year   24,159    13,021    3,097 
Cash and cash equivalents and restricted cash at the end of the year  $16,043   $24,159   $13,021 
Supplemental disclosure of cash flow information:               
Cash received from interest  $1,953   $865   $202 
Cash paid for taxes  $-   $75   $ 
Non-cash transactions:               
Recognition of right-of-use asset and lease liabilities from adoption of ASU 2016-02  $653   $-   $-