On November 26, 2025 Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company focused on liver, cardiometabolic, and gastrointestinal oncology indications, reported financial results for the three and nine months ended September 30, 2025 and recent developments.

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Financial Summary – Third Quarter 2025 vs. Third Quarter 2024

Cash and cash equivalents, short term deposits, restricted cash and marketable debt securities totaled approximately $19.2 million as of September 30, 2025, compared to approximately $15.4 million at December 31, 2024.
Net loss amounted to approximately $2.0 million, or $0.33 per share, for the three months ended September 30, 2025, compared to a net loss of approximately $1.9 million, or $2.31 per share, for the three months ended September 30, 2024.
Research and development expenses amounted to approximately $1.1 million for the three months ended September 30, 2025, compared to approximately $0.7 million for the three months ended September 30, 2024. The increase resulted primarily from clinical and pre-clinical studies expenses.
General and administrative expenses amounted to approximately $1.0 million for the three months ended September 30, 2025, compared to approximately $1.3 million for the three months ended September 30, 2024. The decrease resulted primarily from decrease in salaries and benefit expenses.
Financial income, net amounted to approximately $0.2 million for the three months ended September 30, 2025, compared to financial income of $0.1 million for the three months ended September 30, 2024.
Recent Business Updates

On November 17, 2025, Galmed announced top-line results from its joint research with Virginia Commonwealth University (VCU) evaluating Aramchol’s effect on overcoming drug resistance in gastrointestinal (GI) cancers, which showed that a 3-drug combination of Aramchol, Stivarga and Metformin significantly enhanced gastrointestinal tumor cells, killing in-vivo and in-vitro
On November 18, 2025, Galmed announced meaningful top-line results from its AM-001 Study, a Phase 1 bioavailability study of Aramchol Meglumine
During 2025, Galmed raised approximately $9.3 million through its equity line and ATM facilities.

(Press release, Galmed Pharmaceuticals, NOV 26, 2025, View Source [SID1234660970])

On November 25, 2025 Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted protein degradation medicines in oncology and autoimmune diseases, reported that Arthur T. Sands, M.D., Ph.D., president and chief executive officer, and Hans van Houte, chief financial officer, will participate in a fireside chat at the Piper Sandler 37th Annual Healthcare Conference on Wednesday, December 3, 2025, at 12:30 p.m. ET in New York City.

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The fireside chat will be webcast live and can be accessed via a link in the Investors section of the Nurix website. The archived webcast will be available for 30 days after the event.

(Press release, Nurix Therapeutics, NOV 25, 2025, View Source [SID1234660937])

On November 25, 2025 GV20 Therapeutics (GV20), a clinical-stage AI-powered biotherapeutics company, reported that it has received a milestone payment under its collaboration agreement with Mitsubishi Tanabe Pharma Corporation (MTPC). GV20 and MTPC entered into this collaboration in early 2025 to leverage GV20’s antibodies, which are specifically directed against novel tumor antigen targets discovered through GV20’s proprietary STEAD AI platform, to generate potentially first-in-class antibody-drug conjugates (ADCs).

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"We are pleased to reach this important milestone in our partnership with MTPC," said Ying Gong, Ph.D., Chief Business Officer of GV20. "This progress reflects our shared commitment to rapidly advancing innovative ADC therapies for patients with cancer. We look forward to continuing this positive momentum."

Under the terms of the agreement, GV20 received an upfront payment and is eligible for milestone payments. MTPC received an exclusive right to negotiate a license to these antibodies during the collaboration term.

(Press release, GV20 Therapeutics, NOV 25, 2025, View Source [SID1234660953])

On November 25, 2025 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company with a pipeline of first-in-class1 targeted and immune-mediated therapeutics to fight cancer, reported that it has entered into a definitive agreement with a single healthcare-focused institutional investor for the purchase and sale of 1,172,414 shares of its common stock (or common stock equivalents), at an offering price of $3.625 per share of common stock (or common stock equivalent) in a registered direct offering priced at-the-market under Nasdaq rules. Additionally, in a concurrent private placement, the Company will issue and sell short-term unregistered warrants to purchase up to an aggregate of 1,172,414 shares of common stock at an exercise price of $3.50 per share. The short-term unregistered warrants will be immediately exercisable upon issuance and will expire eighteen months following the effective date of the registration statement registering the resale of the shares of common stock issuable upon exercise of the warrants. The closing of the offering is expected to occur on or about November 25, 2025, subject to the satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The aggregate gross proceeds to the Company from the offering are expected to be approximately $4.25 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The potential additional gross proceeds to the Company from the short-term unregistered warrants, if fully exercised on a cash basis, will be approximately $4.1 million. No assurance can be given that any of such short-term unregistered warrants will be exercised. The Company intends to use the net proceeds from this offering primarily for working capital and general corporate purposes.

The shares of common stock (or common stock equivalents) described above (but not the short-term unregistered warrants issued in the concurrent private placement and the shares issuable thereunder) are being offered and sold by the Company in a registered direct offering pursuant to a "shelf" registration statement on Form S-3 (File No. 333- 280918) that was filed with the Securities and Exchange Commission (the SEC), on July 19, 2024, as amended on January 24, 2025, which was declared effective by the SEC on January 27, 2025. The offering of the securities in the registered direct offering is being made only by means of a base prospectus and prospectus supplement that forms a part of the effective registration statement. A final prospectus supplement and the accompanying base prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying base prospectus, when available, may also be obtained from H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected].

The short-term unregistered warrants issued in the concurrent private placement and the shares issuable upon exercise of such warrants were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and/or Regulation D promulgated thereunder, have not been registered under the Act or applicable state securities laws and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

(Press release, Tempest Therapeutics, NOV 25, 2025, View Source [SID1234660938])

On November 25, 2025 Lunai Bioworks (NASDAQ: LNAI), an AI-powered drug discovery and biodefense company, reported it has secured its first Letter of Intent (LOI) to license its next-generation immune cell therapy, which achieved complete regression of both primary and metastatic pancreatic tumors with no recurrence in humanized preclinical models.

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This milestone follows Lunai’s recent peer-reviewed publication in Vaccines, a successful pre-IND meeting with the U.S. Food and Drug Administration (FDA), and growing third-party recognition from the biotechnology and scientific communities. Lunai has proposed a Phase I clinical trial evaluating its Dendritic Cell Combination Therapy (DCCT) across several high-need solid tumors, including pancreatic cancer, which currently has a five-year survival rate of just 13 percent.

"We are seeing accelerating validation from both researchers and industry partners," said David Weinstein, CEO of Lunai Bioworks. "Independent expert analysis confirms the strength of our data, while early licensing activity reflects growing confidence in this platform’s potential to unlock scalable, off-the-shelf treatments capable of reaching the patients who need them most."

In a widely circulated post on LinkedIn, Benjamin McLeod, Founder of Convey Bio and Co-Host of Bio2Bedside, highlighted the study as a potential breakthrough in cancer immunotherapy.

In humanized mouse models of pancreatic cancer—one of the most lethal and treatment-resistant tumors—Lunai’s DCCT achieved complete regression of both primary and metastatic lesions with no recurrence. These results demonstrate potent, multi-pathway immune activation.

Additionally, the late Dr. Anahid Jewett, Professor at UCLA and a leading authority in tumor immunology commented: "In our view, these results approach what could be called the ‘holy grail’ of cancer research. We observed an 80–90 percent reduction in tumor size and volume across two independent studies, with most of the remaining tissue consisting of immune cells rather than cancer cells."

Lunai is also advancing additional studies and expanding clinical reach for its DCCT platform through collaborations with leading investigators, including Dr. Steven Dubinett (UCLA) for non-small cell lung cancer and Dr. Xiaolin Zi (UC Irvine) for prostate cancer.

"Lunai’s dendritic cell approach has the potential to overcome longstanding barriers in solid tumor treatment," said Dr. Dubinett, Dean of the David Geffen School of Medicine at UCLA.

Lunai’s DCCT introduces a first-in-class, allogeneic immunotherapy designed to scale:

Lunai’s DCCT leverages the natural antigen-presenting power of dendritic cells while eliminating the cost, time, and variability associated with patient-specific manufacturing.
The DCCT is manufactured from healthy donor cells and stored ready-to-use. This off-the-shelf model reduces manufacturing timelines from weeks to days, lowering the overall treatment cost.
In humanized mouse models of pancreatic cancer, one of the most lethal and treatment-resistant tumors, DCCT achieved complete regression of both primary and metastatic lesions with no recurrence.
Lunai Bioworks is preparing for formal licensing negotiations and pre-IND activities in early 2026, advancing toward clinical development of its dendritic cell therapy platform.

(Press release, Lunai Bioworks, NOV 25, 2025, View Source [SID1234660954])