Galmed Pharmaceuticals Ltd. SEC Filings

Galmed Pharmaceuticals Ltd. (GLMD), through its wholly owned subsidiary Colospan Ltd., reported successful first-in-human proof-of-concept clinical study results for a novel intraoperative colon tissue quality assessment platform. Colospan completed a feasibility study in 32 colorectal cancer patients undergoing elective colorectal surgery at three leading Israeli medical centers.

The study showed that quantitative measurement of colon tissue compliance using a novel ex-vivo methodology is technically feasible, with successful measurements obtained in all 32 patients and no measurement failures or procedure-related technical issues. These findings provide the initial clinical foundation for continued development of an intraoperative device intended to give surgeons objective, real-time, quantitative information on colon tissue quality, potentially supporting surgical decision-making and risk assessment for complications such as Low Anterior Resection Syndrome.

The platform is described as Colospan’s second technology, expanding beyond its lead product CG-100, an intraluminal bypass device that has FDA Breakthrough Device Designation, CE marking under EU Medical Device Regulation, and an FDA-approved IDE for investigational use in the United States. Galmed highlights this as part of a broader strategy to build a diversified portfolio in colorectal surgery and gastrointestinal and oncological innovation, alongside its flagship molecule Aramchol.

Galmed Pharmaceuticals Ltd. (GLMD), a clinical-stage biopharmaceutical company, reported new pre-clinical data on a combination of its SCD1 inhibitor Aramchol with Xtandi® (enzalutamide) in prostate cancer models. In a VCaP prostate cancer cell line, the combination produced a 3–4-fold increase in cell death compared with enzalutamide alone, with the interaction strengthening over time.

Galmed links this effect to blocking tumor lipid desaturation pathways that support resistance to standard-of-care anti-androgen therapy. The company highlights that Xtandi recorded $8 billion and $6 billion in global sales in 2024 and 2025 and faces main patent expirations in 2026 (Europe) and 2027 (U.S.), with a U.S. price cut scheduled for 2027.

Galmed has submitted a patent application covering the Aramchol–enzalutamide combination and plans to initiate discussions with potential partners as a possible lifecycle management strategy around Xtandi and future generic competition. In parallel, Galmed continues to advance Aramchol and its CG-100 colorectal surgery device for gastrointestinal, cardiometabolic and oncology indications.

Galmed Pharmaceuticals Ltd. approved a 1-for-8 reverse share split of its ordinary shares, consolidating every eight shares of par value NIS 1.80 into one share of par value NIS 14.40. Trading on the Nasdaq Capital Market on a post-split basis will begin on August 19, 2026.

Following the split, authorized share capital will consist of 112,500,000 ordinary shares with par value NIS 14.40 each, and issued and outstanding shares will change from 8,332,518 to approximately 1,041,565, subject to fractional treatment. Fractional shares will be rounded to the nearest whole share, and outstanding warrants and options will be adjusted proportionately.

Galmed Pharmaceuticals Ltd. reports that Nasdaq has granted an additional 180 calendar days, until January 25, 2027, for the company to regain compliance with Nasdaq’s minimum $1 bid price per share requirement.

Galmed was first notified on January 29, 2026 that its ordinary shares had traded below $1 for 30 consecutive trading days and did not regain compliance by the initial July 28, 2026 deadline. The company requested and received the extended period. Compliance will be restored if the bid price closes at or above $1 per share for at least 10 consecutive trading days before January 25, 2027. This report is incorporated by reference into Galmed’s existing Form S-8 and Form F-3 registration statements.

Galmed Pharmaceuticals Ltd., through its wholly owned subsidiary Galmed Research and Development Ltd., and Yissum Research Development Company of the Hebrew University of Jerusalem Ltd. entered into a mutual termination letter to end their 2021 License Agreement, effective July 31, 2026.

Upon termination, all rights to the licensed technology revert to Yissum, the subsidiary’s obligation to fund ongoing patent expenses ceases as of July 31, 2026, and Galmed will discontinue all activities related to the licensed technology. The company took this step to consolidate operations, reduce costs, and focus resources on commercialization of Colospan and continued development of Aramchol.

Galmed Pharmaceuticals reported progress in developing a new orally dispersible film (ODF), brain-penetrating formulation of its SCD1 inhibitor Aramchol for potential treatment of Parkinson’s disease. In preclinical work, this ODF delivery showed approximately 150% higher systemic bioavailability and about a 300% increase in CNS exposure compared with conventional oral administration.

The company highlights that up to 80% of Parkinson’s patients develop dysphagia, making standard tablets and liquids harder to use. Aramchol’s rapidly dissolving ODF formulation is designed to melt within seconds without water, aiming to ease administration and support long-term adherence. Galmed positions Aramchol ODF as a disease-modifying, mechanism-based approach targeting SCD1-linked α-synuclein aggregation, with co-development or out-licensing opportunities in a $6+ billion global Parkinson’s therapeutics market.

Galmed Pharmaceuticals Ltd. is convening its Annual General Meeting on August 26, 2026 in Ramat Gan, Israel, with a record date of July 27, 2026 and 8,262,953 Ordinary Shares outstanding, each carrying one vote. Shareholders will vote on re-electing two Class III directors until 2029, amending the articles to eliminate par value and change the company’s name to Eocene Ltd., and approving an updated compensation policy for executives and directors that raises the CEO’s potential annual and special bonuses to 275% of base salary, adjusts vesting terms, expands change-of-control benefits, and increases D&O insurance limits to $50 million. Another proposal would increase annual director fees by 20%, from $40,000 to $48,000 (and from $50,000 to $60,000 for an expert external director), citing NIS appreciation of 24.4% and 5.92% cumulative inflation. Shareholders will also vote on reappointing Brightman Almagor Zohar & Co. (Deloitte member firm) as auditor after $185k in 2025 audit fees. Most items require a simple majority, while the articles amendment needs a 75% vote and compensation items require a Special Majority.

Galmed Pharmaceuticals, a clinical-stage biopharma company, announced what it describes as a breakthrough lipid nanoparticle (LNP) formulation of its SCD1 inhibitor Aramchol that selectively targets heart tissue. Developed with Barcode Nanotech using an in vivo and AI-enabled screening platform, the new formulation is designed to redirect Aramchol’s biodistribution away from the liver toward the heart muscle.

Cardiac fibrosis, a key driver of chronic heart failure and associated with an estimated 20.5 million deaths in 2025, currently lacks therapies that directly prevent or reverse fibrosis. Aramchol has shown anti‑fibrotic activity in a Phase 3 MASH study, human heart organoids, and in‑vivo lung and heart models, and Galmed views cardiac‑targeted LNP delivery as a potential route to disease‑modifying treatments. The company also reiterates its near‑term focus on commercializing its CG‑100 colorectal surgery device and advancing Aramchol for GI oncology indications, while positioning the Barcode collaboration as a longer‑term cardiometabolic innovation platform. Galmed states that the first four paragraphs of this announcement are incorporated by reference into its existing S‑8 and F‑3 registration statements.

Galmed Pharmaceuticals reported a Q1 2026 net loss of $1.9M, wider than $1.1M a year earlier, as research and development spending more than doubled to $1.36M. General and administrative expenses rose slightly to $0.68M.

As of March 31, 2026, Galmed held current assets of $16.0M, including $1.6M in cash, $6.1M in short-term deposits and $7.8M in marketable debt securities. Management believes this supports operations for more than 12 months but expects substantial additional funding will be needed to advance development and potential commercialization.

Subsequent to quarter-end, Galmed completed the acquisition of Colospan for $3.3M in cash plus up to $2.0M in performance-based earnout tied to net revenue sales from July 1, 2027. The company also has a $20.0M Standby Equity Purchase Agreement and previously utilized an $8.1M at-the-market facility.