Galmed Pharmaceuticals Reports First Quarter 2025 Financial Results and Provides Business Update

Rhea-AI Summary

Galmed Pharmaceuticals (NASDAQ: GLMD) reported its Q1 2025 financial results with several key developments. The company's net loss decreased to $1.1 million ($0.62 per share) compared to $1.3 million ($2.76 per share) in Q1 2024. Cash position strengthened to $20.1 million after raising $6.5 million since the start of 2025. Research and development expenses remained stable at $0.6 million, while general and administrative expenses decreased to $0.6 million from $0.8 million. Notable developments include promising results in oncology studies showing Aramchol enhancing Bayer's Regorafenib effect in GI cancer models, and signing a term sheet for developing a novel Semaglutide sublingual formulation. The company is actively diversifying its pipeline beyond liver disease into cardiometabolic and oncological indications.

Positive

• Net loss decreased from $1.3M to $1.1M year-over-year
• Cash position strengthened to $20.1M after raising $6.5M in 2025
• General and administrative expenses reduced from $0.8M to $0.6M
• Positive results in oncology studies with Aramchol enhancing Regorafenib's effect
• Strategic expansion into new therapeutic areas through Semaglutide formulation development

Negative

• Continued operational losses of $1.1M in Q1 2025
• R&D expenses remain flat at $0.6M, showing no growth in research investment
• Significant dependence on future clinical trial success and regulatory approvals

Insights

Financial Analyst

Galmed raised $6.5M, shows stable R&D spend, reduced losses, with $20.1M cash providing runway for oncology and semaglutide development.

Galmed has significantly improved its financial position through raising $6.5 million since the beginning of 2025, including $5 million in May, bringing their current cash position to $20.1 million. This represents a meaningful improvement from the $15.9 million reported at the end of Q1. At the current quarterly burn rate of approximately $1.1 million, this provides a substantial runway of over 18 months, assuming operations remain stable.

The Q1 results show some financial discipline, with total operating expenses decreasing to $1.26 million from $1.4 million in the comparable period. The reduction in G&A expenses from $0.8 million to $0.6 million indicates management's efforts to control costs, while R&D expenses remained flat at $0.6 million, suggesting continued but measured investment in their development programs.

The net loss narrowed by 13.4% year-over-year to $1.1 million, or $0.62 per share, compared to $1.3 million, or $2.76 per share in Q1 2024. The significant reduction in loss per share partly reflects an increase in outstanding shares, indicating dilution from their fundraising activities. The weighted average shares outstanding increased nearly threefold from 608,353 to 1,779,695.

While the company remains focused on Aramchol, the announcement of oncology studies demonstrating synergy with Bayer's Regorafenib in GI cancer models represents a potentially valuable pivot. The term sheet for developing a novel semaglutide sublingual formulation could be particularly significant, as GLP-1 agonists like semaglutide represent one of the fastest-growing pharmaceutical segments. This strategic diversification beyond NASH/MASH into oncology and alternative delivery methods for established compounds could present new growth avenues, though investors should note these are early-stage initiatives with significant development hurdles ahead.

Pharmaceutical Development Expert

Galmed's oncology results and semaglutide deal represent strategic pivot beyond NASH, potentially opening valuable new therapeutic avenues.

The announcement of Aramchol enhancing the efficacy of Bayer's Regorafenib in GI cancer models marks a significant strategic expansion beyond Galmed's historical NASH focus. This represents the company's first oncology data, suggesting Aramchol's mechanism may have broader applications than previously explored. Combination approaches are increasingly valuable in oncology, as they can potentially overcome resistance mechanisms and improve efficacy without proportionally increasing toxicity.

The term sheet for developing a novel sublingual semaglutide formulation is particularly noteworthy. Semaglutide, currently marketed as Ozempic, Wegovy, and Rybelsus, is a GLP-1 receptor agonist that has demonstrated remarkable efficacy for weight management and diabetes. However, current formulations are limited to injectable or oral routes with relatively low bioavailability. A sublingual formulation could potentially address patient compliance issues associated with injections while potentially improving the bioavailability limitations of the current oral formulation.

This development aligns with Galmed's stated intention to "expand and diversify" their pipeline beyond Aramchol for NASH/MASH and fibrosis. The company appears to be leveraging its drug development expertise to pursue opportunities in high-value therapeutic areas - particularly metabolic disease and oncology. The company's experience with Aramchol in metabolic conditions provides some relevant background for these new directions.

Both initiatives represent early-stage opportunities with significant development work ahead. The Regorafenib combination would require extensive clinical validation beyond preclinical models, while developing a novel formulation of semaglutide will face significant formulation, bioavailability, and intellectual property challenges. Nevertheless, these developments represent potentially valuable diversification for a company that had previously been heavily focused on a single asset in NASH.

TEL AVIV, Israel, May 22, 2025 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company for cardiometabolic diseases and GI oncological indications, reports financial results for the three months ended March 31, 2025 and recent developments.

Key Recent Developments

• Announced First Time Results in Oncology Studies: Aramchol Significantly Enhances Bayer's Regorafenib Effect in GI Cancer Models
• Signed Term Sheet for the Development of Novel Semaglutide Sublingual Formulation
• Raised $6.5 million since the beginning of 2025. Company's current cash balance is $20.1 million

Financial Summary – First Quarter 2025 vs. First Quarter 2024*:

• Cash and cash equivalents, short term deposits, restricted cash and marketable debt securities totaled approximately $15.9 million as of March 31, 2025, compared to approximately $15.4 million at December 31, 2024. During May 2025, the Company raised an additional $5.0 million. As a result, as of the date hereof, the Company's current cash balance is approximately $20.1 million.
• Net loss amounted to approximately $1.1 million, or $0.62 per share, for the three months ended March 31, 2025, compared to a net loss of approximately $1.3 million, or $2.76 per share, for the three months ended March 31, 2024.
• Research and development expenses amounted to approximately $0.6 million for the three months ended March 31, 2025, compared to approximately $0.6 million for the three months ended March 31, 2024.
• General and administrative expenses amounted to approximately $0.6 million for the three months ended March 31, 2025, compared to approximately $0.8 million for the three months ended March 31, 2024. The decrease in general and administrative expenses for the three months ended March 31, 2023 resulted primarily from a decrease in professional services expenses.
• Financial income, net amounted to approximately $0.2 million for the three months ended March 31, 2025, compared to financial income of $0.1 million for the three months ended March 31, 2024.

About Galmed Pharmaceuticals Ltd.

We are a biopharmaceutical company focused on the development of Aramchol. We have focused almost exclusively on developing Aramchol for the treatment of liver disease and we are currently seeking to advance the development of Aramchol for oncological indications outside of NASH and fibrosis. In addition, as part of our growth strategy, we are actively pursuing opportunities to expand and diversify our product pipeline specifically targeting cardiometabolic indications and other innovative product candidates that align with our core expertise in drug development.

Forward-Looking Statements:

Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to our product development efforts, business, financial condition, results of operations, strategies or prospects, as well as statements, other than historical facts, that address activities, events or developments that we intend, expect, project, believes or anticipate will or may occur in the future. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to, the development and approval of the use of Aramchol or any other product candidate for indications outside of non-alcoholic steatohepatitis, or NASH, also known as metabolic dysfunction-associated steatohepatitis, or MASH, and fibrosis or in combination therapy; the timing and cost of any pre-clinical or clinical trials of Aramchol or any other product candidate we develop; completion and receiving favorable results of any pre-clinical or clinical trial; regulatory action with respect to Aramchol or any other product candidate by the U.S. Food and Drug Administration, or the FDA, or the European Medicines Authority, or EMA, including but not limited to acceptance of an application for marketing authorization, review and approval of such application, and, if approved, the scope of the approved indication and labeling; the commercial launch and future sales of Aramchol and any future product candidates; our ability to comply with all applicable post-market regulatory requirements for Aramchol, or any other product candidate in the countries in which we seek to market the product; our ability to achieve favorable pricing for Aramchol, or any other product candidate; third-party payor reimbursement for Aramchol, or any other product candidate; our estimates regarding anticipated capital requirements and our 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; our ability to obtain and maintain adequate protection of our intellectual property; the possibility that we may face third-party claims of intellectual property infringement; our ability to manufacture our product candidates in commercial quantities, at an adequate quality or at an acceptable cost; our ability to establish adequate sales, marketing and distribution channels; intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; our expectations regarding licensing, acquisitions and strategic operations; current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk; our ability to maintain the listing of our ordinary shares on The Nasdaq Capital Market; and security, political and economic instability in the Middle East that could harm our business, including due to the current security situation in Israel. We believe these forward-looking statements are reasonable; however, these statements are only current predictions and are subject to known and unknown risks, uncertainties and other factors that may cause our or our industry's actual results, levels of activity, performance or achievements to be materially different from those anticipated by the forward-looking statements. We discuss many of these risks in our Annual Report on Form 20-F for the year ended December 31, 2024 filed with the SEC on April 2, 2025 in greater detail under the heading "Risk Factors." Given these uncertainties, you should not rely upon forward-looking statements as predictions of future events. All forward-looking statements attributable to us or persons acting on our behalf speak only as of the date hereof and are expressly qualified in their entirety by the cautionary statements included in this report. We undertake no obligations to update or revise forward-looking statements to reflect events or circumstances that arise after the date made or to reflect the occurrence of unanticipated events. In evaluating forward-looking statements, you should consider these risks and uncertainties.

* This unaudited preliminary financial information regarding the company's financial results for the three months and quarter ended March 31, 2025, is based upon the  estimates and subject to completion of the company's quarter-end financial results. Moreover, this financial information has been prepared solely on the basis of currently available information by, and is the responsibility of, management. The company's independent registered public accounting firm has not audited, reviewed or performed any procedures with respect to such preliminary estimates or the accounting treatment thereof and does not express an opinion or any other form of assurance with respect thereto. This preliminary financial information is not a comprehensive statement of the company's financial results for this period.

 

GALMED PHARMACEUTICALS LTD.
Consolidated Balance Sheets
U.S. Dollars in thousands, except share data and per share data
		As of March 31, 2025			As of December 31, 2024
Assets
Current assets
Cash and cash equivalents		$	4,767		$	4,652
Short-term deposit			3,544			3,496
Restricted Cash			122			121
Marketable debt securities			7,418			7,183
Other receivables			447			672
Total current assets			16,298			16,124
Investment in associate at fair value			2,119			2,119
Loan to associate			267			257
Total non-current assets			2,386			2,376
Total assets		$	18,684		$	18,500
Liabilities and stockholders' equity
Current liabilities
Trade payables		$	1,308		$	1,308
Other payables			499			865
Total current liabilities			1,807			2,173
Stockholders' equity
Ordinary shares par value NIS 1.80 per share; Authorized 50,000,000; Issued and outstanding: 2,258,034 shares as of March 31, 2025 and 1,664,884 shares as of December 31, 2024			1,029			742
Additional paid-in capital			217,818			216,470
Accumulated other comprehensive loss			(397)			(416)
Accumulated deficit			(201,573)			(200,469)
Total stockholders' equity			16,877			16,327
Total liabilities and stockholders' equity		$	18,684		$	18,500

 

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,
		2025			2024
Research and development expenses		$	634		$	635
General and administrative expenses			630			766
Total operating expenses			1,264			1,401
Financial income, net			(160)			(126)
Net loss		$	1,104		$	1,275
Basic and diluted net loss per share		$	0.62		$	2.10 (*)
Weighted-average number of shares outstanding used in computing basic and diluted net loss per share			1,779,695			608,353 (*)
*) 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,
		2025			2024
Cash flow from operating activities
Net loss		$	(1,104)		$	(1,275)
Adjustments required to reconcile net loss to net cash used in operating activities
Depreciation and amortization			-			9
Stock-based compensation expense			101			153
Amortization of premium on marketable debt securities			34			6
Interest income from short-term deposits			(48)			(5)
Loss (gain) from realization of marketable debt securities			(19)			1
interest income from loan to associate			(10)			-
Finance expenses			-			1
Finance expenses related to SEPA			20			-
Changes in operating assets and liabilities:
Decrease in other receivables			225			226
Decrease in trade payables			-			(496)
Decrease in other payables			(366)			(448)
Net cash used in operating activities			(1,167)			(1,830)
Cash flow from investing activities
Purchase of available for sale securities			(1,032)			(898)
Investment in short term deposits			-			(375)
Consideration from sale of available for sale securities			801			1,705
Net cash provided by investing activities			(231)			432
Cash flow from financing activities
Issuance of ordinary shares in relation to ATM			1,439			-
Issuance of ordinary shares in relation to SEPA			75			-
Net cash provided by financing activities			1,514			-
Increase (decrease) in cash and cash equivalents and restricted cash			116			(1,398)
Cash and cash equivalents and restricted cash at the beginning of the period			4,773			2,978
Cash and cash equivalents and restricted cash at the end of the period		$	4,889		$	1,580
Supplemental disclosure of cash flow information:
Cash received from interest		$	171		$	112

 

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SOURCE Galmed Pharmaceuticals Ltd.

FAQ

What were GLMD's Q1 2025 financial results?

Galmed reported a net loss of $1.1M ($0.62 per share), reduced from $1.3M in Q1 2024. The company had $20.1M in cash after raising $6.5M in 2025, with R&D expenses at $0.6M and G&A expenses at $0.6M.

What are the key developments in Galmed Pharmaceuticals' oncology research?

Galmed announced that Aramchol significantly enhances the effect of Bayer's Regorafenib in GI cancer models, marking their first significant results in oncology studies.

How much cash does Galmed Pharmaceuticals (GLMD) have as of Q1 2025?

As of May 2025, Galmed's cash balance is approximately $20.1 million, which includes $5.0 million raised during May 2025.

What new strategic directions is GLMD pursuing in 2025?

GLMD is expanding beyond liver disease by developing Aramchol for oncological indications and pursuing cardiometabolic opportunities, including a new Semaglutide sublingual formulation development.

How did GLMD's operating expenses change in Q1 2025 compared to Q1 2024?

Total operating expenses decreased from $1.4M to $1.26M. R&D expenses remained stable at $0.6M, while G&A expenses decreased from $0.8M to $0.6M.