Galmed Pharmaceuticals Reports First Quarter 2023 Financial Results and Recent Developments

Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD) (“Galmed” or the “Company”), a clinical-stage biopharmaceutical company for liver and fibro-inflammatory diseases reports financial results for the three months ended March 31, 2023 and recent developments

 

TEL AVIV, Israel, June 1, 2023 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company for liver and fibro-inflammatory diseases reports financial results for the three months ended March 31, 2023 and recent developments

Galmed Pharmaceuticals Logo

Recent Developments

  • Initiated a new clinical program to evaluate its lead compound, Aramchol meglumine for the treatment of Primary Sclerosing Cholangitis (PSC), a rare disease for which there is no approved treatment;
  • Phase 2 proof of concept PSC study to be conducted in collaboration with the Stravitz–Sanyal Institute for Liver Disease and Metabolic Health Virginia Commonwealth University;
  • Formed a strategic partnership with Onkai, Inc., leading an investment round of $6 million in Onkai, an AI-powered digital platform that facilitates health equity in underserved communities across the US, Enabling faster and diverse enrollment to clinical trials;
  • The Company is discontinuing its evaluation of strategic alternatives; and
  • Nasdaq notified the Company that it regained compliance with the Nasdaq minimum bid price rule.

Financial Summary – First Quarter 2023 vs. First Quarter 2022:

  • Cash and cash equivalents, short term deposit, restricted cash and marketable debt securities totaled $12.2 million as of March 31, 2023, compared to $13.8 million at December 31, 2022.
  • Net loss amounted to $1.8 million, or $1.09 per share, for the three months ended March 31, 2023, compared to a net loss of $6.1 million, or $3.67 per share, for the three months ended March 31, 2022.
  • Research and development expenses amounted to approximately $1.1 million for the three months ended March 31, 2023, compared to approximately $4.8 million for the three months ended March 31, 2022. The decrease resulted primarily from a decrease in clinical trial expenses.
  • General and administrative expenses amounted to approximately $0.9 million for the three months ended March 31, 2023, compared to approximately $1.3 million for the three months ended March 31, 2022. The decrease resulted primarily from a decrease in share based compensation and professional services expenses.
  • Financial income, net amounted to approximately $0.2 million for the three months ended March 31, 2023, compared to financial expense of $0.05 million for the three months ended March 31, 2022.

About Galmed Pharmaceuticals Ltd.

We are a clinical stage biopharmaceutical company focused on the development of Aramchol for liver and fibro-inflammatory diseases. We have focused almost exclusively on developing Aramchol for the treatment of NASH and are currently developing Aramchol for PSC and exploring the feasibility of developing Aramchol for other fibro-inflammatory indications outside of liver disease. We are also collaborating with the Hebrew University in the development of Amilo-5MER, a 5 amino acid synthetic peptide.

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 PSC clinical trial and our pivotal Phase 3 ARMOR trial, or the ARMOR Study (if re-initated) or any other pre-clinical or clinical trials; completion and receiving favorable results of our planned PSC clinical trial and our the ARMOR Study for Aramchol (if re-initiated) 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 29, 2023, 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

   

As of

 
     

March 31,

   

December 31,

 
     

2023

   

2022

 
     

Unaudited

   

Audited

 

Assets

                 
                   

Current assets

                 

Cash and cash equivalents

 

$

1,672

 

$

2,016

 

Short term deposit

   

754

   

-

 

Restricted Cash

   

114

   

114

 

Marketable debt securities

   

9,726

   

11,769

 

Other receivables

   

568

   

825

 

Total current assets

   

12,834

   

14,724

 
                   

Right of use assets

   

176

   

223

 

Property and equipment, net

   

105

   

114

 

Investment in convertible loan

   

1,676

   

1,500

 

Total non-current assets

 

1,957

   

1,837

 
                   

Total assets

 

$

14,791

 

$

16,561

 
                   

Liabilities and stockholders' equity

                 
                   

Current liabilities

                 

Trade payables

$

2,266

 

$

2,560

 

Other payables

   

535

   

534

 

Total current liabilities

   

2,801

   

3,094

 
                   

Non-current liabilities

                 

Lease obligation

 

$

-

 

$

44

 

Total non-current liabilities

   

-

   

44

 
                   

Ordinary shares par value NIS 0.01 per share; Authorized 20,000,000; Issued and

                 

outstanding: 1,680,232 shares as of March 31, 2023 and December 31, 2022 *)

   

70

   

70

 

Additional paid-in capital

   

200,435

   

200,138

 

Accumulated other comprehensive loss

   

(645)

   

(745)

 

Accumulated deficit

   

(187,870)

   

(186,040)

 

Total stockholders' equity

   

11,990

   

13,423

 
                   

Total liabilities and stockholders' equity

 

$

14,791

 

$

16,561

 

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

 

*) Retroactively adjusted to reflect the reverse split

                 
                 
   

 

 

GALMED PHARMACEUTICALS LTD.

 

Consolidated Statements of Operations (Unaudited)

 

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

 
               
     

 

Three months ended

     
     

March 31,

     
   

 

2023

 

 

2022

   

Research and development expenses

 

$

1,083

 

$

4,796

   
                     

General and administrative expenses

   

919

   

1,296

   
                     

Total operating expenses

   

2,002

   

6,092

   
                     

Financial (income) expense, net

   

(172)

   

51

   
                     

Net loss

 

$

1,830

 

$

6,143

   
                     

Basic and diluted net loss per share

 

$

1.09

 

$

3.67

   

Weighted-average number of shares outstanding used in
computing basic and diluted net loss *)

                   
                   

  per share

   

1,680,232

   

1,672,566

   
                     

*) Retroactively adjusted to reflect the reverse split

   

 

 

GALMED PHARMACEUTICALS LTD.

 

Consolidated Statements of Cash Flows (Unaudited)

 

U.S. Dollars in thousands

 
           
   

 

Three months ended

 
   

 

March 31,

 
   

 

2023

 

 

2022

 

Cash flow from operating activities

               
                 

Net loss

$

(1,830)

 

$

(6,143)

 
                 

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

               

Depreciation and amortization

   

8

   

9

 

Stock-based compensation expense

   

297

   

457

 

Amortization of premium on marketable debt securities

   

10

   

31

 

Amortization of discount on long term assets

   

(176)

   

-

 

Interest income from short-term deposits

   

(4)

   

-

 

Loss from realization of marketable debt securities

   

32

   

145

 

Finance expenses

   

4

   

(10)

 

Changes in operating assets and liabilities:

               

Decrease in other accounts receivable

   

257

   

282

 

Decrease in trade payables

   

(294)

   

(36)

 

Increase (decrease) in other accounts payable

   

1

   

(187)

 

Net cash used in operating activities

   

(1,695)

   

(5,452)

 
                 

Cash flow from investing activities

               

Purchase of available for sale securities

   

2,494

   

-

 

Investment in short term deposits

   

(750)

   

-

 

Consideration from sale of available for sale securities

   

(393)

   

6,309

 

Net cash provided by investing activities

   

1,351

   

6,309

 
                 

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

   

(344)

   

857

 

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

   

2,130

   

2,998

 

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

 

$

1,786

 

$

3,855

 
                 

Supplemental disclosure of cash flow information:

               

Cash received from interest

$

64

$

77

 
                 

 

 

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SOURCE Galmed Pharmaceuticals Ltd.

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