On November 10, 2025 Cogent Biosciences, Inc. ("Cogent") (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported that it has commenced underwritten public offerings of $200 million aggregate principal amount of its convertible senior notes due 2031 (the "Convertible Notes" and such offering, the "Convertible Notes Offering") and $200 million of its shares of common stock (the "Equity Offering").

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Cogent intends to grant the underwriters a 30-day option to purchase up to an additional $30 million aggregate principal amount of Convertible Notes, solely to cover over-allotments in the Convertible Notes Offering, and a 30-day option to purchase up to an additional $30 million of shares of common stock in the Equity Offering.

The closing of neither the proposed Convertible Notes Offering nor the Equity Offering is conditioned upon the closing of the other offering. The proposed offerings are subject to market and other conditions, and there can be no assurance as to whether or when the proposed offerings may be completed, or as to the actual size or terms of the offerings.

The Convertible Notes will be general, unsecured, senior obligations of Cogent and interest will be payable semi-annually in arrears. The Convertible Notes will mature on November 15, 2031, unless earlier converted, redeemed, or repurchased by Cogent. Upon conversion, Cogent will pay or deliver, as applicable, cash, shares of its common stock or a combination of cash and shares of common stock, at its election. The interest rate, conversion rate, offering price and other terms are to be determined upon the pricing of the Convertible Notes.

Cogent intends to use the net proceeds from the proposed Convertible Notes Offering and the proposed Equity Offering to repay $50 million of loans outstanding under its existing term loan facility, plus accrued interest and associated fees, and the remainder for development and regulatory activities relating to bezuclastinib and other product candidates, the anticipated commercial launch and commercialization of bezuclastinib, as well as for working capital and general corporate purposes.

Jefferies and J.P. Morgan are acting as joint book-running managers for the proposed Convertible Notes Offering.

J.P. Morgan, Jefferies, Leerink Partners and Guggenheim Securities are acting as joint-book running managers for the proposed Equity Offering. LifeSci Capital is acting as lead manager and Raymond James is acting as co-manager for the proposed Equity Offering.

The securities described above will be offered pursuant to an automatic shelf registration statement on Form S-3ASR (File No. 333-291384), which was filed with the Securities and Exchange Commission ("SEC") on November 7, 2025 and automatically became effective upon filing.

Preliminary prospectus supplements and the accompanying base prospectuses relating to and describing the terms of each proposed offering will be filed with the SEC. The final terms of the proposed offerings will be disclosed in final prospectus supplements and accompanying base prospectuses to be filed with the SEC. The securities described above have not been qualified under any state blue sky laws. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or 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 jurisdiction. The proposed offerings can be made only by means of prospectus supplements and accompanying base prospectuses, copies of which may each be obtained at the SEC’s website at www.sec.gov, or by request to Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at [email protected] and [email protected]; Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected]; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Ave., New York, NY 10017, or by telephone at (212) 518-9544, or by email at [email protected].

(Press release, Cogent Biosciences, NOV 10, 2025, View Source [SID1234659708])

On November 10, 2025 Verismo Therapeutics, a clinical-stage CAR T company developing a novel KIR-CAR platform technology, reported the presentation of new preclinical data from its lead clinical pipeline, SynKIR-110 to target mesothelin on solid tumors, at the Society of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2025 Annual Meeting. The oral presentation showcased their latest preclinical data demonstrating SynKIR-110’s improved safety profile and enhanced anti-tumor activity compared to conventional CAR T therapies.

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The oral presentation, "A Novel NK-cell Based Split-Signaling Killer Immunoglobulin Receptor (KIR)-Based CAR T Targeting Mesothelin, SynKIR-110, Shows Increased Safety Profile and Increased Efficacy in vitro and in vivo" was delivered by Dr. Nora Yucel, Principal Scientist at Verismo Therapeutics.

Key Findings:

Enhanced Tumor-Specific Serial Killing: In vitro, SynKIR-110 showed sustained killing of MSLN-expressing tumor cells while minimizing off-target activation and cytokine release.
Reduced Exhaustion and Improved Functional Persistence: Unlike conventional 41BB-CD3ζ CAR T cells, SynKIR-110 exhibited reduced activation and exhaustion markers in vitro, suggesting less tonic signaling and functional exhaustion.
Improved Anti-Tumor Activity: In NSG mouse models of mesothelioma, SynKIR-110 induced deep and prolonged regression of implanted tumors and metastatic spread.
Less Off-tumor Activity: SynKIR-110 cells were selectively enriched in tumors and reduced in, normal tissues – contrasting with the off-tumor accumulation in lung and normal tissues observed with conventional 41BB-CD3ζ CAR T designs.
"Conventional CAR T therapies have faced significant safety and efficacy challenges in treating solid tumors," said Dr. Laura Johnson, CSO/COO of Verismo Therapeutics. "Our SynKIR platform presents a truly novel signaling platform approach designed to allow CAR T cells to rest and recover when not engaged with tumors, which in turn may reduce T cell exhaustion and improve safety and efficacy of tumor-specific killing."

SynKIR-110 is currently being evaluated in a Phase 1 clinical trial (NCT05568680) in patients with advanced ovarian cancer, cholangiocarcinoma, and mesothelioma, and has received both Orphan Drug and Fast Track Designations from the U.S. Food and Drug Administration (FDA) for the treatment of mesothelioma.

(Press release, Verismo Therapeutics, NOV 10, 2025, View Source [SID1234659744])

On November 10, 2025 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported positive data from its Phase 3 PEAK trial of bezuclastinib plus sunitinib in patients with imatinib-resistant or intolerant Gastrointestinal Stromal Tumors (GIST). The combination reached a median progression free survival (mPFS) of 16.5 months compared to sunitinib monotherapy, which reached a mPFS of 9.2 months (HR=0.50, CI: 0.39-0.65; p<0.0001). In addition, the combination of bezuclastinib with sunitinib resulted in a 46% objective response rate (ORR) compared to 26% with sunitinib monotherapy (p<0.0001). Based on these data, Cogent is on track to submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for bezuclastinib in GIST in the first half of 2026. Cogent also plans to present detailed results from the PEAK trial at an upcoming scientific conference in the first half of 2026.

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"It is a historic day for Cogent Biosciences and the GIST patient community," said Andrew Robbins, Cogent’s President and Chief Executive Officer. "We are extremely excited to announce positive results from the Phase 3 PEAK trial of bezuclastinib plus sunitinib, which have far surpassed our expectations for the activity of this combination in patients with imatinib-resistant or intolerant GIST. With these incredible results, including a greater than seven-month improvement on mPFS – reducing the rate of progression or death by half – the bezuclastinib combination is poised to become the new standard of care for treatment of second-line GIST patients. We are pleased to have an existing Expanded Access Program available to GIST patients who have an urgency to access this novel treatment immediately and look forward to partnering with regulatory agencies to make this combination broadly available to patients as soon as possible."

"The results from the PEAK trial are truly transformative and practice changing," said Neeta Somaiah, M.D., Professor and Department Chair, Department of Sarcoma Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX. "Following regulatory approval, I expect the bezuclastinib combination to be rapidly adopted as the new standard of care treatment for the majority of patients in the second-line GIST setting."

"Imatinib-resistant or intolerant GIST patients have waited nearly 20 years for a new second-line treatment option. The remarkable results of the PEAK study suggest that wait has come to an end," said Sara Rothschild, Executive Director, The Life Raft Group. "Like so many in the GIST community, we’ve actively followed this trial with real anticipation. On behalf of GIST patients around the world, we share our excitement for the hope that the bezuclastinib combination may bring these patients and their families."

PEAK Phase 3 Trial Results

PEAK is a global, randomized Phase 3 clinical trial evaluating bezuclastinib in combination with sunitinib vs. sunitinib monotherapy in patients with imatinib-resistant or intolerant GIST. In the top-line results, as of the cutoff date, September 30, 2025, the bezuclastinib combination demonstrated a substantial and highly statistically significant clinical benefit on the primary endpoint of progression free survival (PFS), reducing risk of disease progression or death compared to the current standard of care by 50% (hazard ratio of 0.50, 95% CI: 0.39 – 0.65). mPFS, as assessed by blinded independent central review, was 16.5 months for the bezuclastinib combination vs. 9.2 months for sunitinib monotherapy. Additionally, the bezuclastinib combination demonstrated an unprecedented ORR in imatinib-resistant patients, with 46% of patients treated with the bezuclastinib combination achieving an objective response compared to 26% of patients treated with sunitinib. At the time of this analysis, data for overall survival remains immature.

Based on these data, and the number of ongoing patients receiving treatment on the bezuclastinib arm, the estimated mean duration of treatment for the bezuclastinib combination is projected to exceed 19 months.

Safety Data

As of the data cutoff, the bezuclastinib combination was generally well tolerated, and no unique risks were observed with the novel combination when compared to the known safety profile of sunitinib. The most commonly reported Grade 3+ treatment emergent adverse events in either arm (bezuclastinib combination vs. sunitinib) included: Hypertension (29.4% vs. 27.4%), Neutropenia (15.2% vs. 15.4%), ALT/AST increased (10.8% vs. 1.4%), Anemia (9.3% vs. 4.8%) and Diarrhea (7.8% vs. 7.2%). 7.4% of patients on the bezuclastinib combination and 3.8% of patients on sunitinib monotherapy discontinued study treatment(s) due to treatment related adverse events. Hepatic adverse events were predominantly transient and manageable lab abnormalities; the majority of which were low grade, non-serious, reversible and asymptomatic. In the combination arm, ALT/AST elevations led to bezuclastinib dose reductions in 12.7% of patients with only 3 subjects (1.5%) discontinuing bezuclastinib for ALT/AST elevations. All Grade 3 ALT/AST elevations resolved, and no Grade 4 elevations were reported across the study.

Complete analysis of the Phase 3 PEAK data is ongoing, and Cogent plans to present detailed results at a major medical conference in the first half of 2026.

Anticipated Upcoming Milestones

Announce top-line results from the pivotal APEX trial in December 2025. APEX is a registration-directed, global, open-label trial in patients with Advanced Systemic Mastocytosis (AdvSM)
Present multiple bezuclastinib presentations at the 67th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper), including two oral presentations from the pivotal SUMMIT trial in NonAdvanced Systemic Mastocytosis (NonAdvSM) patients
Present initial data from Cogent’s novel JAK2 V617F inhibitor at ASH (Free ASH Whitepaper), showcasing its best-in-class potential
Submit Cogent’s first NDA for bezuclastinib in NonAdvSM patients by the end of 2025
Submit NDA for bezuclastinib in imatinib-resistant or intolerant GIST patients in the first half of 2026
Webcast Information
Cogent will host a live webcast today, November 10, 2025 at 8:00 a.m. ET to discuss these results from PEAK with participation from Neeta Somaiah, M.D., Professor and Department Chair, Department of Sarcoma Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX. The live event can be accessed on the Investors & Media page of Cogent’s website at investors.cogentbio.com. A replay of the webcast will be available approximately two hours after the completion of the event and will be archived for up to 30 days.

(Press release, Cogent Biosciences, NOV 10, 2025, View Source [SID1234659709])

On November 10, 2025 Precision BioSciences, Inc. (Nasdaq: DTIL) ("Precision"), a clinical stage gene editing company utilizing its novel proprietary ARCUS platform to develop in vivo gene editing therapies for high unmet need diseases, reported that it has agreed to sell by way of an underwritten offering 10,815,000 shares of its common stock and accompanying warrants to purchase up to 5,407,500 shares of common stock at a combined price of $6.14 and, in lieu of common stock to certain investors, pre-funded warrants to purchase up to 1,400,000 shares of its common stock and accompanying one-half of a warrant to purchase up to 700,000 shares of common stock at a combined price of $6.139995, which represents the per share offering price for the shares of common stock less the $0.000005 per share exercise price for each pre-funded warrant. The gross proceeds to Precision from the offering, before deducting the underwriting discounts and commissions and offering expenses, are expected to be approximately $75 million. Each whole warrant has an exercise price of $7.25 per share, is exercisable immediately and will expire five years following the date of issuance. The deal includes participation from new and existing investors, including Aberdeen Investments, Bleichroeder LP, Driehaus Capital Management, Empery Asset Management LP, Lynx1 Capital Management, Octagon Capital, Readout Capital, Sphera Funds Management, Stonepine Capital Management, as well as other leading life sciences investors.

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The offering is expected to close on or about November 12, 2025, subject to customary closing conditions. All shares of common stock, pre-funded warrants and accompanying one-half of a warrant to purchase shares of common stock to be sold in the offering will be sold by Precision. Precision intends to use the net proceeds of the offering to help fund ongoing and planned research and development, and for working capital and general corporate purposes.

Guggenheim Securities is acting as sole book-running manager for the offering.

The securities described above were offered by means of a prospectus supplement dated November 10, 2025, and accompanying prospectus dated June 15, 2023, forming part of Precision’s effective shelf registration statement (File No. 333-272540). The prospectus supplement and accompanying prospectus relating to this offering will be filed with the U.S. Securities and Exchange Commission (the "SEC") and will be available on the SEC’s website located at www.sec.gov. Copies of the prospectus supplement and the accompanying prospectus may also be obtained, when available, by contacting: Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, by telephone at (212) 518-9544, or by email at [email protected].

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

(Press release, Precision Biosciences, NOV 10, 2025, View Source [SID1234659725])

On November 10, 2025 Vascarta Inc., a healthspan focused, clinical stage biopharmaceutical company advancing safe, patient friendly therapies for pain, inflammation, and, in collaboration with the City University of New York (CUNY), reported the publication of a preclinical study demonstrating that STO-1, a first-in-class drug candidate, can selectively eliminate glioblastoma (GBM) cells in mice while avoiding harmful autoimmune reactions.

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STO-1 is a proprietary hybrid molecule in which curcumin is linked to paclitaxel with a linker that gets broken when STO-1 enters a cell. In the study, mice treated with STO-1 experienced a 67% long-term survival rate, with several animals achieving complete tumor clearance. The therapy works in part by reprogramming deactivated tumor-associated immune cells to attack the tumor, while leaving healthy immune function intact. This minimizes the prospect of undesirable side effects often seen with immunotherapies.

Dr. Probal Banerjee, the senior author and Professor, Biochemistry, Biology, Neuroscience, Chemistry at the College of Staten Island, CUNY, said:
"Unlike other immune therapies, which can trigger dangerous autoimmune reactions, STO-1 targets only the tumor-associated cells. This study demonstrates a promising new approach to treating glioblastoma safely."

Dr. Richard Prince, Chairman, Chief Executive and President, Vascarta, stated:
"These results highlight the potential of STO-1 to offer a safe and effective option for patients with glioblastoma without the side effects."

(Press release, City University of New York, NOV 10, 2025, View Source [SID1234659745])