PR Newswire | Nov 12, 2020 07:01AM EST

11/12 06:00 CST

Galmed Pharmaceuticals Reports Third Quarter 2020 Financial Results- Conference Call and Webcast Today at 8:30 a.m. ET / 5:30 a.m. PT - TEL AVIV, Israel, Nov. 12, 2020

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(tm), 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.

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(tm), 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 As of September December 30, 31, 2020 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 58 58shares as of December 31, 2019

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 Nine months ended September 30, September 30,

2020 2019 2020 2019

Research and development $ 6,536 $ 4,054 $ 17,057 $ 10,817expenses

General and administrative 1,054 953 2,811 2,931expenses

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 $ 0.32 $ 0.21 $ 0.87 $ 0.58per share

Weighted-average number ofshares outstanding used incomputing basic

and diluted net loss per 21,268,730 21,123,418 21,191,196 21,109,421share

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 operatingactivities

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 periodCash 718 (5,868)and cash equivalents and restricted cash at the end of the period

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 $ - $ 6792016-02

Assets acquired under operating leases $ 35 $ -

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SOURCE Galmed Pharmaceuticals Ltd.