Galmed Pharmaceuticals Provides Business Update and Reports Fourth Quarter and Year End 2021 Financial Results

Rhea-AI Summary

Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD) announced positive interim results from the ARMOR study, showcasing Aramchol's effectiveness in improving fibrosis in NASH patients. The net loss for 2021 was $32.5 million, with R&D expenses increasing to $27.2 million, driven by ongoing clinical trials. Despite a reduced net loss in Q4 2021 ($7.5 million) compared to Q4 2020, cash reserves fell to $34.9 million. The company indicates a strong focus on advancing Aramchol through its Phase 3 study while also exploring additional collaborations.

Positive

• Aramchol shows promising interim results in fibrosis improvement for NASH patients with a 65% and 100% improvement rate using paired and AI evaluations.
• Reduced net loss in Q4 2021 ($7.5 million) compared to Q4 2020 ($10.3 million).
• Advancements in the ARMOR study indicate strong progress in clinical development.

Negative

• Total net loss for 2021 increased to $32.5 million, compared to $28.8 million in 2020.
• Cash reserves decreased significantly from $51.0 million at the end of 2020 to $34.9 million by December 31, 2021.
• Research and development expenses rose to $27.2 million, reflecting increased clinical trial costs.

- Conference Call and Webcast Today at 8:30 a.m. ET / 5:30 a.m. PT -

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.

 

 

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

 

 

View original content:https://www.prnewswire.com/news-releases/galmed-pharmaceuticals-provides-business-update-and-reports-fourth-quarter-and-year-end-2021-financial-results-301537095.html

SOURCE Galmed Pharmaceuticals Ltd.

FAQ

What are the financial results for Galmed Pharmaceuticals for 2021?

Galmed reported a net loss of $32.5 million for 2021, with R&D expenses of $27.2 million.

How did Aramchol perform in the ARMOR study?

Aramchol showed a high rate of fibrosis improvement in NASH patients, with 65% improvement in paired evaluations.

What is the current cash position of Galmed Pharmaceuticals?

As of December 31, 2021, Galmed had cash reserves of $34.9 million.

When is the conference call for Galmed Pharmaceuticals?

The conference call is scheduled for May 2, 2022, at 8:30 a.m. ET.