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])

On November 25, 2025 MacroGenics, Inc. (Nasdaq: MGNX), a biopharmaceutical company focused on developing innovative antibody-based therapeutics for the treatment of cancer, reported that Eric Risser, President and CEO of MacroGenics, will participate in a fireside chat at the 8th Annual Evercore Healthcare Conference on Thursday, December 4, at 7:55 am ET in Miami, FL.

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A webcast of the presentation may be accessed under "Events & Presentations" in the Investor Relations section of MacroGenics’ website at View Source The Company will maintain an archived replay of the webcast on its website for 30 days.

(Press release, MacroGenics, NOV 25, 2025, View Source [SID1234660972])

On November 25, 2025 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported that it will present at the Piper Sandler 37th Annual Healthcare Conference to take place on December 2-4, 2025.

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Piper Sandler 37th Annual Healthcare Conference

Date / Time: December 2, 2025, at 1:00 PM ET
Format: Fireside Chat
Location: New York, NY
Webcast Link: here

Webcasts from the conferences will also be available on UroGen’s Investor Relations website. A replay will be available on the site for approximately 90 days.

(Press release, UroGen Pharma, NOV 25, 2025, View Source [SID1234660939])

On November 25, 2025 Agendia, Inc., a leader in precision oncology for breast cancer, reported that it will present new data demonstrating the utility of the MammaPrint 70-gene assay (MP) and BluePrint 80-gene assay (BP) genomic profiling in guiding the use of anthracycline chemotherapy in patients with hormone receptor positive, HER2-negative (HR+HER2–) early-breast cancer (EBC) at the 2025 San Antonio Breast Cancer Symposium (SABCS). The company will also present four additional posters at SABCS, which takes place December 9-12 in San Antonio, Texas. The complete list of poster presentations can be found here.

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The latest 3-year analysis from the prospective FLEX Study, in an update to data presented at ASCO (Free ASCO Whitepaper) 2024, confirms that patients with MP High 2 (H2), Luminal B, HR+HER2- EBC experience substantially improved invasive disease-free survival when treated with anthracycline-based chemotherapy (AC-T) compared to a regimen without anthracycline (TC). While outcomes for High 1 (H1) patients were similar between patients matched for clinical features, H2 patients saw a striking absolute invasive disease-free survival (IDFS) benefit of 10.7% with AC-T, achieving 100% 3-year IDFS. These results provide the strongest real-world evidence to date that MP can help identify the subset of HR+HER2- patients most likely to benefit from anthracycline-based therapy. Together, these findings underscore the clinical value of genomic profiling in guiding more precise and effective adjuvant treatment decisions.

"With the addition of propensity score matching, these results demonstrate how the genomic information provided by MammaPrint and BluePrint can meaningfully support adjuvant treatment decisions and therapy selection for patients with HR+HER2- early breast cancer," said William Audeh, MD, MS, Chief Medical Officer at Agendia. "By distinguishing High 2 patients – who derive substantial benefit from the addition of anthracycline to their chemotherapy regimen – from those with High 1 disease, who do not, we can better tailor therapy to each patient’s underlying tumor biology. These data further establish the value of real-world evidence and reinforces the power of precision genomics to guide more effective, individualized care and improve outcomes for patients with breast cancer."

Poster #PS2-07-03 | Dec. 10, 5:00 p.m. – 6:30 p.m. | Presenter: Joyce O’Shaughnessy

Improved 3-year IDFS with anthracycline-based therapy for patients with 70-gene signature High 2, Luminal B, HR+HER2– EBC

In this real-world cohort of 1,261 HR+/HER2– breast cancer patients with MP High Risk and BP Luminal B tumors from the FLEX Study, outcomes were evaluated in propensity-matched treatment groups with a median follow-up of 3.2 years. Patients with MP High Risk 2 tumors demonstrated a statistically significant improvement of 10.7% in invasive disease-free survival when treated with anthracycline-based therapy compared to TC-only regimens, while those with High 1 tumors saw no difference. These results provide real-world evidence that MP can identify the HR+/HER2- patients most likely to benefit from anthracycline-based therapy, underscoring the clinical value of genomic profiling in guiding more precise and effective adjuvant treatment decisions.

Agendia will present four additional abstracts that collectively highlight the broad clinical impact of MP and BP in optimizing treatment decisions and improving outcomes for patients with HR+/HER2– EBC, including a poster demonstrating that MP is more prognostic than histologic grade, as described below.

Poster #PS5-04-19 | Dec. 12, 12:30 p.m. – 2:00 p.m. | Presenter: Erin Cobain

70-gene signature high risk classification provides stronger prognostic value than histologic grade in HR+HER2– EBC

In this real-world analysis of 1,407 HR+HER2– EBC patients enrolled in the FLEX Study, patients with MP High 2 tumors treated with chemotherapy had significantly worse five-year distant relapse-free survival compared to High 1 tumors (86.4% vs 93.1%; p < 0.001), even after adjusting for clinicopathologic factors such as grade. Notably, grade lost independent prognostic value when corrected for MP score – highlighting the limitations of relying on histology alone and establishing MP as a superior prognostic biomarker.

"The data being presented at SABCS continue to build on the growing body of evidence supporting the expanded clinical utility of MammaPrint and BluePrint," said Mark Straley, Chief Executive Officer. "Each study adds a new dimension to how our tests inform multiple treatment decisions across the care journey for patients with early-stage breast cancer – helping more women receive the right care based on the unique biology of their tumor."

(Press release, Agendia, NOV 25, 2025, View Source [SID1234660955])