Galmed Pharmaceuticals Reports Third Quarter 2020 Financial Results

 

TEL AVIV, Israel, Nov. 12, 2020 /PRNewswire/ -- 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™, an oral therapy for the treatment of nonalcoholic steatohepatitis, or NASH and fibrosis, reports financial results for the three and nine months ended September 30, 2020. The Company will host a conference call and webcast at 08:30 ET today.

 

Galmed Pharmaceuticals Ltd Logo

 

Financial Summary – Third Quarter 2020 vs. Third Quarter 2019:

  • Cash and cash equivalents, restricted cash, short-term deposits and marketable debt securities totaled $58.7 million as of September 30, 2020, compared to $75.6 million at December 31, 2019.
  • Net loss amounted to $6.9 million, or $0.32 per share, for the three months ended September 30, 2020, compared to a net loss of $4.5 million, or $0.21 per share, for the three months ended September 30, 2019.
  • Research and development expenses amounted to approximately $6.5 million for the three months ended September 30, 2020, compared to approximately $4.1 million for the three months ended September 30, 2019. The increase resulted primarily from an increase in clinical trial expenses in connection with our ongoing ARMOR study.
  • General and administrative expenses amounted to approximately $1.1 million for the three months ended September 30, 2020, compared to approximately $1.0 million for the three months ended September 30, 2019. The increase in general and administrative expenses for the three months ended September 30, 2020 resulted primarily from an increase in the cost of the Company's D&O insurance policy premium.
  • Financial income, net amounted to $0.7 million for the three months ended September 30, 2020, compared to financial income, net of $0.5 million for the three months ended September 30, 2019. The increase primarily relates to realization of unrealized gains from prior periods.  

 

 

Conference Call & Webcast:

Thursday November 12, 2020, 8:30 AM Eastern Time.

Toll Free: 1-877-425-9470

Toll/International: 1-201-389-0878

Israel Toll Free: 1 809 406 247

Conference ID: 13711943

Webcast: http://public.viavid.com/index.php?id=141982

Replay Dial-In Numbers

Toll Free: 1-844-512-2921

Toll/International: 1-412-317-6671

Replay Pin Number: 13711943

Replay Start: Thursday November 12, 2020, 11:30 AM ET

Replay Expiry: Thursday November 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. We are also collaborating with the Hebrew University in the development of Amilo-5MER, a 5 amino acid synthetic peptide and plan to initiate a first in human study by the fourth quarter of 2020.

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 or any other pre-clinical or clinical trials; completion and receiving favorable results of the ARMOR Study for Aramchol or any other pre-clinical or clinical trial; the impact of the COVID-19 pandemic; regulatory action with respect to Aramchol or any other product candidate 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 or any other product candidate in the countries in which it seeks to market the product; Galmed's ability to achieve favorable pricing for Aramchol or any other product candidate; Galmed's expectations regarding the commercial market for NASH patients or any other indication; third-party payor reimbursement for Aramchol or any other product candidate; Galmed's estimates regarding anticipated capital requirements and Galmed's needs for additional financing; market adoption of Aramchol or any other product candidate by physicians and patients; the timing, cost or other aspects of the commercial launch of Aramchol or any other product candidate; the development and approval of the use of Aramchol or any other product candidate 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.

 

GALMED PHARMACEUTICALS LTD.

Consolidated Balance Sheets

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

     

As of
September 30,

2020

 

As of
December 31,
2019

 

Assets

               

Current assets

               

Cash and cash equivalents

$

16,648

$

15,931

 

Restricted Cash

   

113

 

112

 

Short-term deposits

   

10,423

 

27,938

 

Marketable debt securities

   

31,514

 

31,622

 

Other receivable

   

642

 

827

 

Total current assets

   

59,340

 

76,430

 
               

Right of use assets

   

437

 

538

 

Property and equipment, net

   

176

 

171

 

Total non-current assets

   

613

 

709

 
                 

Total assets

$

59,953

$

77,139

 
                 

Liabilities and stockholders' equity

               
                 

Current liabilities

               

Trade payables

$

5,151

$

5,999

 

Other payables

   

899

 

935

 

Total current liabilities

   

6,050

 

6,934

 
                 

Non-current liabilities

               

Lease obligation

$

247

$

352

 

Total non-current liabilities

   

247

 

352

 
                 

Ordinary shares par value NIS 0.01 per share; Authorized 50,000,000; Issued and outstanding:

               

21,312,043 shares as of September 30, 2020; 21,139,385 shares as of December 31, 2019

   

58

 

58

 

Additional paid-in capital

   

178,938

 

176,696

 

Accumulated other comprehensive gain

   

90

 

35

 

Accumulated deficit

   

(125,430)

 

(106,936)

 

Total stockholders' equity

   

53,656

 

69,853

 
                 

Total liabilities and stockholders' equity

$

59,953

$

77,139

 
 

 

 

 

GALMED PHARMACEUTICALS LTD.

Consolidated Statements of Operations (Unaudited)

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

 
     

Three months ended
September 30,

 

Nine months ended
September 30,

       
     

2020

 

2019

 

2020

 

2019

Research and development expenses

 

$

6,536

$

 

4,054

$

17,057

$

10,817

                   

General and administrative expenses

   

1,054

 

953

 

2,811

 

2,931

                   

Total operating expenses

   

7,590

 

5,007

 

19,868

 

13,748

                   
                   

Financial income, net

   

(685)

 

(493)

 

(1,374)

 

(1,573)

                   

Net loss

$

6,905

$

4,514

$

18,494

$

12,175

                   
                   

Basic and diluted net loss per share

$

0.32

$

0.21

$

0.87

$

0.58

                   
                   

Weighted-average number of shares outstanding used in computing basic

                 

and diluted net loss per share

   

21,268,730

 

21,123,418

 

21,191,196

 

21,109,421

 

 

 

 

             

GALMED PHARMACEUTICALS LTD.

Consolidated Statements of Cash Flows (Unaudited)

U.S. Dollars in thousands

 
   

Nine months ended

   

September 30

   

2020

 

2019

             
   

$

(18,494)

 

$

(12,175)

             

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

           

Depreciation and amortization

   

28

   

27

Stock-based compensation expense

   

1,474

   

1,546

Amortization of premium (discount) on marketable debt securities

   

36

   

(93)

Interest income from short-term deposits

   

(268)

   

(161)

Gain from realization of marketable debt securities

   

(522)

   

(10)

Changes in operating assets and liabilities:

           

Decrease (Increase) in other accounts receivable

   

185

   

(680)

Increase (decrease) in trade payables

   

(848)

   

928

Decrease in other accounts payable

   

(40)

   

(253)

Net cash used in operating activities

   

(18,449)

   

(10,871)

             

Cash flow from investing activities

           

Purchase of property and equipment

   

(33)

   

(9)

Investment in available for sale securities

   

(45,226)

   

(72,600)

Investment in short term deposits, net

   

17,783

   

(14,180)

Consideration from sale of available for sale securities

   

45,875

   

91,697

Net cash provided by investing activities

   

18,399

   

4,908

             

Cash flow from financing activities

           

Proceeds from exercise of options

   

61

   

95

Issuance of Ordinary shares upon ATM, net of issuance cost

   

707

   

-

Net cash provided in financing activities

   

768

   

95

             

Increase (decrease) in cash and cash equivalents and restricted cash

           

Cash and cash equivalents and restricted cash at the beginning of the period Cash
and cash equivalents and restricted cash at the end of the period

   

718

   

(5,868)

     

16,043

   

24,159

   

$

16,761

 

$

18,291

             
             

Supplemental disclosure of cash flow information:

           

Cash received from interest

 

$

966

 

$

1,542

             

Non-cash transactions:

           

Recognition of right-of-use asset and lease liability from adoption of ASU 2016-02

 

$

-

 

$

679

Assets acquired under operating leases

 

$

35

 

$

-

 

 

 

Cision View original content:http://www.prnewswire.com/news-releases/galmed-pharmaceuticals-reports-third-quarter-2020-financial-results-301171763.html

SOURCE Galmed Pharmaceuticals Ltd.

 
 
Company Codes: Berlin:GPH, NASDAQ-SMALL:GLMD, Frankfurt:GPH, Stuttgart:GPH
 

Back to news