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TEL AVIV, Israel, May 2, 2022 /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, provides today updated information on the Company's scientific and clinical development programs and reports financial results for the three and twelve months ended December 31, 2021.

Galmed Pharmaceuticals Logo

 

 

Recent Clinical & Scientific Developments

  • Announced positive interim results from Open-Label part of the ARMOR study showing that treatment with Aramchol 300mg BID resulted in a high rate of fibrosis improvement using three separate biopsy reading methodologies (NASH CRN, Ranked paired reading and a Quantitative Digital Pathology image analysis and artificial intelligence (AI) method), with a larger treatment effect with longer duration of therapy.
  • Results of post baseline biopsies performed either at 24 weeks or at 48 weeks from 46 subjects with NASH and F1-3 that received Aramchol showed greater histological improvement at week 48 in both paired and AI evaluations (65% and 100% respectively) compared to NASH CRN scoring (40%).

Financial Summary – Full Year 2021 vs. Full Year 2020; 4Q21 vs. 4Q20:

For the three and twelve months ended December 31, 2021, the Company recorded a net loss of $7.5 million and $32.5 million or $0.30 and $1.32 per share, respectively, compared with a net loss of $10.3 million and $28.8 million, or $0.48 and $1.35 per share, for the three and twelve months ended December 31, 2020.

Research and development expenses were $27.2 million for the twelve months ended December 31, 2021, compared with $26.1 million for the twelve months ended December 31, 2020. The increase for the twelve months resulted primarily from an increase in clinical trial expenses in connection with the Company's ongoing ARMOR study, partially offset by a decrease in expenses related to CMC and formulation expenses.  

For the three months ended December 31, 2021, research and development expenses totaled $6.3 million, which compares with $9.0 million for the same period in 2020. The decrease for the three months resulted primarily from a decrease in clinical trial expenses and a decrease in expenses related to CMC and formulation expenses.

The Company incurred general and administrative expenses of $5.7 million for the twelve months ended December 31, 2021, compared with $4.1 million for the twelve months ended December 31, 2020. The increase for the twelve months primarily resulted from an increase in salaries and benefits expenses, and as well from an increase in the cost of the Company's D&O insurance policy premium.

For the three months ended December 31, 2021, general and administrative expenses totalled $1.2 million, which compares with $1.3 million for the same period in 2020.

Financial income, net amounted to $0.4 million for the twelve months ended December 31, 2021, compared with $1.4 million for the twelve months ended December 31, 2020. For the three months ended December 31, 2021, financial income, net totalled $0.04 million, which compares with $0.07 million for the same period in 2020.

  • Cash and cash equivalents, restricted cash, short-term deposits, and marketable debt securities totaled $34.9 million as of December 31, 2021, compared with $51.0 million as of December 31, 2020.

More detailed information can be found in the Company's Annual Report on Form 20-F, a copy of which has been filed with the Securities and Exchange Commission and posted on the Company's website at www.galmedpharma.com. You may request a copy of the Company's Form 20-F, at no cost to you, by writing to the Chief Financial Officer of the Company at 16 Tiomkin Street, Tel Aviv, Israel, 6578317 or by calling +972-3-693-8448.

Conference Call & Webcast:
May 2, 2022, 8:30 AM ET
 Toll Free: 1-877-425-9470
Toll/International: 1-201-389-0878
Israel Toll Free: 1 809 406 247
Conference ID: 13727793
Webcast:  https://viavid.webcasts.com/starthere.jsp?ei=1535647&tp_key=893b75d833

Replay Dial-In Numbers
Toll Free: 1-844-512-2921
Toll/International: 1-412-317-6671
Replay Pin Number:  13727793
Replay Start: Monday May 2, 2022, 11:30 AM ET
Replay Expiry: Monday May 16, 2022, 11:59 PM ET

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.

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 May 2, 2022, 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 (Audited)

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







As of December 31,







2021



2020


Assets










Current assets












Cash and cash equivalents





$

2,884



$

6,947


Restricted cash






114




113


Short-term deposits






-




3,807


Marketable debt securities






31,931




40,132


Other accounts receivable






1,125




812


Total current assets






36,054




51,811














Operating lease right-of-use assets






406




394


Property and equipment, net






145




176


Total non-current assets






551




570














Total assets





$

36,605



$

52,381














Liabilities and stockholders' equity
























Current liabilities












Trade payables





$

4,871



$

7,046


Other accounts payable






1,008




966


Total current liabilities






5,879




8,012














Non-current liabilities












Operating lease liabilities, net of current portion





$

229



$

216


Total non-current liabilities






229




216














Stockholders' equity












Ordinary shares, par value NIS 0.01 per share; Authorized 50,000,000 shares;
Issued and outstanding: 25,088,414 shares as of December 31, 2021; 21,325,975
shares as of December 31, 2020






70




58


Additional paid-in capital






198,772




179,530


Accumulated other comprehensive income (loss)






(171)




272


Accumulated deficit






(168,174)




(135,707)


Total stockholders' equity






30,497




44,153














Total liabilities and stockholders' equity





$

36,605



$

52,381


 

 

 

GALMED PHARMACEUTICALS LTD.

Consolidated Statements of Operations (Audited)

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




Year ended December 31,



2021



2020



2019

Research and development expenses



27,220




26,082




18,180

General and administrative expenses



5,661




4,128




4,196

Total operating loss



32,881




30,210




22,376

Financial income, net



(414)




(1,439)




(1,915)

Net loss


$

32,467



$

28,771



$

20,461













Basic and diluted net loss per share


$

1.32



$

1.35



$

0.97

Weighted-average number of shares outstanding used in
computing basic and diluted net loss per share



24,597,638




21,280,787




21,114,399

 

 

 

GALMED PHARMACEUTICALS LTD.

Consolidated Statements of Cash Flows (Audited)

U.S. Dollars in thousands




Year ended December 31,



2021



2020



2019

Cash flow from operating activities
























Net loss for the year


$

(32,467)



$

(28,771)



$

(20,461)

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












Depreciation and amortization



42




39




35

Amortization of discount (premium) on marketable debt securities



121




90




(105)

Gain on sale of marketable debt securities



(37)




(527)




(9)

Finance expenses



6




31




3

Interest income from short-term deposits



7




(285)




(63)













Stock-based compensation expense



1,886




2,066




2,231

Changes in operating assets and liabilities:
























Decrease (increase) in other accounts receivable



(313)




15




(609)

Increase (decrease) in trade payables



(2,175)




1,047




4,185

Increase (decrease) in other accounts payable



38




8




(144)

Net cash used in operating activities



(32,892)




(26,287)




(14,937)













Cash flow from investing activities












Purchase of property and equipment



(11)




(44)




(12)

Increase in restricted deposit



(1)




-




-

Investment in securities, available for sale



(13,569)




(55,034)




(72,600)

Proceeds from sale of securities, available for sale



21,243




47,198




101,098

Proceeds from (investment in) short-term deposits, net



3,800




24,416




(21,808)

Net cash provided by investing activities



11,462




16,536




6,678













Cash flow from financing activities












Issuance of ordinary shares in at-the-market offering, net of
issuance costs



8,147




-




-

Issuance of ordinary shares, net of issuance costs (**)



9,221




707




-

Proceeds from exercise of options



(*)




61




143

Net cash provided by financing activities



17,368




768




143

Decrease in cash, cash equivalents and restricted cash



(4,062)




(8,983)




(8,116)

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



7,060




16,043




24,159

Cash, cash equivalents and restricted cash at the end of the year


$

2,998



$

7,060



$

16,043













Supplemental disclosure of cash flow information:












Cash received from interest


$

562



$

1,192



$

1,953













Non-cash transactions:












Recognition of right-of-use asset and lease liabilities from
adoption of ASU 2016-02, net


$

-



$

-



$

653













Right-of-use assets obtained in exchange for new operating lease liabilities, net


$

199



$

35



$

-




(*) Represents amount less than $1

 

 

 

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SOURCE Galmed Pharmaceuticals Ltd.

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