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])

On November 10, 2025 Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in predictive computational target discovery powered by AI/ML, reported financial results for the third quarter of 2025 and provided a corporate update.

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"I am thrilled to lead Compugen as our strong fundamentals and differentiated science gain clinical momentum," said Eran Ophir, Ph.D., President and CEO of Compugen. "Recent data at ESMO (Free ESMO Whitepaper) from our partner AstraZeneca and others reinforce our long-held view that not all anti-TIGIT antibodies are the same, and that the antibody-Fc format matters. This is because Fc reduced anti-TIGIT programs, like our fully owned anti-TIGIT, COM902, and AstraZeneca’s anti-PD-1/TIGIT bispecific rilvegostomig, preserve beneficial T cells and avoid depletion of peripheral T-regs in contrast to Fc-active anti-TIGITs and therefore have the potential for improved efficacy and safety profile. At ESMO (Free ESMO Whitepaper), AstraZeneca presented data from ARTEMIDE-01 showing rilvegostomig was well tolerated with promising efficacy confirming its potential in checkpoint naïve NSCLC with notable low rate of treatment related discontinuation supporting differentiation of the Fc-reduced format. AstraZeneca also presented data from TROPION-PanTumor03, evaluating the combination of rilvegostomig and Datroway, which showed promising efficacy and manageable safety underscoring the potential of next-generation IO bispecific plus ADCs. In addition, AstraZeneca announced it expects to launch its eleventh Phase 3 trial for rilvegostomig."

Dr. Ophir continued, "We presented pooled Phase 1 data at ESMO (Free ESMO Whitepaper) 2025 showing that COM701, our Fc-reduced anti-PVRIG antibody, is well tolerated as monotherapy and in combination and delivers durable responses in heavily pretreated platinum resistant ovarian cancer patients, with a median progression-free survival of 10.5 months in patients who derived clinical benefit. The data also showed that COM701 biology is differentiated, reflected in responses seen across PD-L1 expression levels. This data is important as it characterized responding patients, guiding the design of our ongoing blinded and randomized MAIA-ovarian platform trial evaluating single agent COM701 maintenance therapy in platinum sensitive ovarian cancer. Sites have been activated in the U.S., Israel and France, and we now estimate interim analysis in Q1 2027. We are also advancing GS-0321, a potential first-in-class anti-IL18BP antibody licensed to Gilead and presented the trial design at SITC (Free SITC Whitepaper) last week."

Dr. Ophir concluded, "Our solid financial position with cash runway expected into the third quarter of 2027 enables us to advance our differentiated IO pipeline and leverage our AI/ML powered computational discovery platform Unigen to discover novel ways to activate the immune system against cancer. I am confident in our fully owned programs, strengthened by validating partnerships with AstraZeneca and Gilead, which together offer over $1 billion in potential milestones and royalties."

Third Quarter 2025 Financial Highlights
Cash: As of September 30, 2025, Compugen had approximately $86.1 million in cash, cash equivalents, short-term bank deposits, and investment in marketable securities.

Compugen expects that its cash and cash-related balances will be sufficient to fund its operating plans into the third quarter of 2027. This does not include any cash inflows. The Company has no debt.

During October 2025, subsequent to the financial results for the quarter ended September 30, 2025, a total of approximately 0.8 million shares were sold through the Company’s ATM facility contributing net proceeds of approximately $1.6 million.

Revenue: Compugen reported approximately $1.9 million in revenues for the third quarter ended September 30, 2025, compared to approximately $17.1 million in revenues for the comparable period in 2024. The revenues reported in the third quarters of 2025 and 2024 reflect recognition of portions of both the upfront payment and the IND milestone payment from the license agreement with Gilead.

R&D expenses for the third quarter of 2025 were approximately $5.8 million compared to approximately $6.3 million for the comparable period in 2024.

G&A expenses were approximately $2.2 million for the third quarter of 2025 and $2.6 million for the comparable period in 2024.

Net loss for the third quarter of 2025 was approximately $6.98 million, or $0.07 per basic and diluted share, compared with a net profit of approximately $1.28 million, or $0.01 per basic and diluted share, in the third quarter of 2024.

Full financial tables are included below

Conference Call and Webcast Information
The Company will hold a conference call today, November 10, 2025, at 8:30 AM ET to review its third quarter 2025 results. To access the conference call by telephone, please dial 1-866-744-5399 from the United States, or +972-3-918-0644 internationally. The call will also be available via live webcast through Compugen’s website, located at the following link. Following the live audio webcast, a replay will be available on the Company’s website.

(Press release, Compugen, NOV 10, 2025, View Source [SID1234659710])

On November 10, 2025 Propanc Biopharma, Inc. (Nasdaq: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing new treatments for patients suffering from recurrent and metastatic cancer, reported that it has entered into a securities purchase agreement with Hexstone Capital LLC ("Hexstone"), a family office that has invested in a significant number of Digital Asset Treasury (DAT) companies across a range of digital assets including BTC, ETH, SOL, DOGE, ATH, OG, and INJ. The agreement is for a private placement of up to $100 Million in convertible preferred stock and will be deployed to support its digital asset acquisition strategy and accelerate the Company’s R&D pipeline, focusing on PRP entering a First-In-Human study second half of 2026. Upon closing, the Company received an initial investment of $1 million based on the issue of 100 shares of newly designated Series C Convertible Preferred Stock, each with a par value of $0.01 and an initial stated value of $10,000.

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"We are entering a transformative phase for the Company as we work on building our digital asset base and strengthening our balance sheet, which will enable us to accelerate our unique proenzyme technology to clinical development and beyond," said James Nathanielsz, Propanc’s Chief Executive Officer. "Our business model will revolutionize the way we fund and grow our intellectual property portfolio, fast track our R&D processes and expand our development program so that we can target not only patients suffering from metastatic cancer from solid tumors, but several chronic diseases based upon the mechanism of action of proenzyme therapy. This is our vision. We look forward to updating you as we progress."

Additionally, Propanc will issue 9,900 Warrants to Hexstone, each entitling the purchase of one share of Preferred Stock at $10,000 per share, totaling up to $99 million in potential funding. The Warrants are exercisable, immediately, and will remain valid for 12 months. Subject to equity conditions and beneficial ownership limits, the Company may call up to 500 Warrants per calendar month at $0.01 each, allowing the exercise of up to $5 million in Preferred Stock per month—less any Warrants already exercised by Hexstone during that period.

Further details can be found in the Company’s Form 8-K filed with the SEC and accessible at www.sec.gov.

(Press release, Propanc, NOV 10, 2025, View Source [SID1234659726])