On November 5, 2025 Vir Biotechnology, Inc. (Nasdaq: VIR), reported a corporate update and announced financial results for the third quarter ended September 30, 2025.

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"Our third quarter demonstrated exceptional execution across our clinical portfolio," said Marianne De Backer, Chief Executive Officer, Vir Biotechnology. "We completed ECLIPSE 1 enrollment approximately two months ahead of schedule and continue to see strong momentum across ECLIPSE 2 and 3, positioning us well for our hepatitis delta regulatory submissions. We are excited to provide guidance for a comprehensive VIR-5500 data update in the first quarter of 2026, and we recently expanded into first-line prostate cancer with our ARPI combination study. These achievements reflect our team’s commitment to delivering transformative therapies to patients with significant unmet medical needs."

Pipeline Programs

Chronic Hepatitis Delta (CHD)

The ECLIPSE 1 Phase 3 trial has completed enrollment approximately two months ahead of the Company’s internal projections. Primary completion is expected in the fourth quarter of 2026, with topline data expected in the first quarter of 2027. ECLIPSE 1 evaluates the combination of tobevibart and elebsiran compared to deferred treatment in regions such as the U.S. where bulevirtide is not available or in other regions where its use is limited.
The ECLIPSE 2 Phase 3 trial continues enrolling well, and topline data are expected in the first quarter of 2027. ECLIPSE 2 evaluates the switch to the combination of tobevibart and elebsiran in participants who have not achieved undetectable hepatitis delta virus RNA with bulevirtide treatment.
The ECLIPSE 3 Phase 2b trial is progressing ahead of schedule with strong enrollment momentum, and topline data are expected in the first quarter of 2027. ECLIPSE 3 evaluates the combination of tobevibart and elebsiran compared to bulevirtide monotherapy in bulevirtide treatment-naïve participants.
Following positive data presented at American Association for the Study of Liver Diseases (AASLD) The Liver Meeting 2024, the Company will present Week 48 endpoint results from its SOLSTICE Phase 2 clinical study, in patients with CHD at AASLD The Liver Meeting 2025. The oral presentation will take place on Sunday, November 9.
Solid Tumors

VIR-5500, a PRO-XTEN dual-masked T-cell engager (TCE) targeting prostate-specific membrane antigen (PSMA), continues to advance through Phase 1 dose escalation as a monotherapy in heavily pre-treated patients with metastatic castration-resistant prostate cancer (mCRPC) and has demonstrated promising early anti-tumor activity and a favorable safety profile.
First patient dosed in Phase 1 clinical study of VIR-5500 in combination with ARPIs in first-line mCRPC.
The Company plans to share a comprehensive VIR-5500 data update in late-line patients in the first quarter of 2026.
VIR-5818, a PRO-XTEN dual-masked TCE targeting HER2, continues in a Phase 1 dose escalation study in combination with pembrolizumab.
VIR-5818 is the only dual-masked HER2-targeting TCE in clinical development and is being evaluated in multiple tumor types, including metastatic colorectal cancer (CRC).
VIR-5525, a PRO-XTEN dual-masked TCE targeting EGFR, continues enrollment in the Phase 1 trial as expected.
VIR-5525 leverages learnings from VIR-5500 and VIR-5818 and is being evaluated in a variety of EGFR-expressing solid tumors in areas of high unmet need, such as non-small cell lung cancer, CRC, head and neck squamous cell carcinoma, and cutaneous squamous cell carcinoma.
Preclinical Pipeline Candidates

Harnessing the Company’s deep immune system expertise combined with its discovery and engineering platform and proprietary dAIsY (data AI structure and antibody) AI engine, the Company continues to advance multiple undisclosed PRO-XTEN masked TCEs directed toward validated targets with potential application across a number of solid tumors.
Third Quarter 2025 Financial Results

Cash, Cash Equivalents and Investments: As of September 30, 2025, the Company had $810.7 million in cash, cash equivalents and investments, representing a decrease of approximately $81.4 million during the third quarter of 2025.

Revenues: Total revenues for the third quarter of 2025 were $0.2 million compared to $2.4 million for the same period in 2024.

Cost of Revenue: The change in cost of revenue for the third quarter of 2025 compared to the same period in 2024 was nominal.

Research and Development Expenses (R&D): R&D expenses for the third quarter of 2025 were $151.5 million, which included $5.5 million of non-cash stock-based compensation expense, and $75.0 million of milestone payments paid from restricted cash, compared to $195.2 million for the same period in 2024, which included $8.9 million of non-cash stock-based compensation expense and $102.8 million of license expenses. The decrease was primarily driven by lower license expenses and cost savings from previously announced restructuring initiatives, partially offset by higher clinical expenses from our ECLIPSE registrational program for CHD and progression of our oncology programs.

The $75.0 million milestone payment to former shareholders of Amunix Pharmaceuticals, Inc. was triggered by VIR-5525 achieving first-in-human dosing and was paid from restricted cash held in escrow since the execution of the license agreement with Sanofi S.A. (Sanofi), therefore having no impact on our reported cash position or runway. The prior year license expenses were primarily due to the recognition of the $102.8 million Sanofi upfront payment as in-process research and development expense in the third quarter of 2024.

Selling, General and Administrative Expenses (SG&A): SG&A expenses for the third quarter of 2025 were $22.2 million, which included $5.8 million of non-cash stock-based compensation expense, compared to $25.7 million for the same period in 2024, which included $7.8 million of non-cash stock-based compensation expense. The decrease was largely due to efficiencies and cost savings from previously announced restructuring initiatives.

Restructuring, Long-Lived Assets Impairment and Related Charges, Net: The Company incurred no restructuring, long-lived assets impairment and related charges, net for the third quarter of 2025 compared to $12.7 million for the same period in 2024. The decrease was due to the fact that our restructuring initiatives implemented in prior years were substantially completed by the end of 2024.

Other Income: Other income for the third quarter of 2025 was $10.5 million compared to $17.8 million for the same period in 2024. The decrease was primarily driven by lower interest income.

Provision for Income Taxes: The provision for income taxes for the third quarter of 2025 was nominal.

Net Loss: Net loss for the third quarter of 2025 was $163.1 million, or $1.17 per share, basic and diluted, compared to a net loss of $213.7 million, or $1.56 per share, basic and diluted for the same period in 2024.

2025 Financial Guidance

Based on current operating plans, the Company expects its cash, cash equivalents and investments to fund operations into mid-2027.

Conference Call

Vir Biotechnology will host a conference call to discuss the third quarter results at 1:30 p.m. PT / 4:30 p.m. ET today. A live webcast will be available on View Source and will be archived for 30 days.

(Press release, Vir Biotechnology, NOV 5, 2025, View Source [SID1234659492])

On November 5, 2025 Bristol Myers Squibb (NYSE: BMY) reported that it has priced a public offering (the "Offering") of senior unsecured notes in a combined aggregate principal amount of €5 billion (collectively, the "Notes"). The Notes will be issued by Bristol Myers Squibb’s wholly-owned subsidiary, BMS Ireland Capital Funding Designated Activity Company, in five tranches: (i) €750,000,000 aggregate principal amount of 2.973% Notes due 2030, (ii) €1,150,000,000 aggregate principal amount of 3.363% Notes due 2033, (iii) €1,150,000,000 aggregate principal amount of 3.857% Notes due 2038, (iv) €750,000,000 aggregate principal amount of 4.289% Notes due 2045, and (v) €1,200,000,000 aggregate principal amount of 4.581% Notes due 2055. The Notes will be fully and unconditionally guaranteed on a senior unsecured basis by Bristol-Myers Squibb Company. Bristol Myers Squibb expects that the closing of the Offering will occur on November 10, 2025, subject to the satisfaction of customary closing conditions.

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On November 3, 2025, Bristol Myers Squibb commenced a tender offer (the "Tender Offer") to purchase, for cash, various series of its outstanding notes (the "Tender Offer Notes"). Bristol Myers Squibb intends to use the net proceeds of the Offering, together with approximately $3.0 billion of cash on hand, (i) to fund the Tender Offer and/or other repurchase, repayment or redemption of the notes subject to the Tender Offer, (ii) to pay fees and expenses in connection therewith and with the Offering and (iii) to the extent of any remaining proceeds, for general corporate purposes. The Offering is not contingent on the consummation of the Tender Offer or the purchase of any of the Tender Offer Notes in connection therewith.

Citigroup Global Markets Limited, Barclays Bank PLC, BNP PARIBAS, J.P. Morgan Securities plc and Société Générale are acting as joint lead managers and joint book-running managers for the Offering.

The Offering of the Notes is being made pursuant to an effective shelf registration statement (including a prospectus and preliminary prospectus supplement) (File Nos. 333-283810 and 333-283810-01) filed with the U.S. Securities and Exchange Commission (the "SEC"). You may get these documents for free by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, Bristol Myers Squibb, any underwriter or any dealer participating in the Offering will arrange to send you the prospectus and the preliminary prospectus supplement (or, if available, the prospectus supplement) if you request it by contacting Bristol Myers Squibb Investor Relations or Citigroup Global Markets Limited at +1 800-831-9146, Barclays Bank PLC at +1 888-603-5847, BNP PARIBAS at +44 0-20-7595-8222, J.P. Morgan Securities plc (for non-U.S. investors) at +44-20 7134-2468 or J.P. Morgan Securities LLC (for U.S. investors) at (212) 834-4533 (call collect) and Société Générale at +1 855-881-2108.

(Press release, Bristol-Myers Squibb, NOV 5, 2025, View Source [SID1234659460])

On November 5, 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 financial results for the quarter ended September 30, 2025 and provided a corporate update.

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"We are continuing our strategic alternatives process with the goal of maximizing value for stockholders," said Stephen Brady, president and chief executive officer of Tempest. "In addition, we look forward to the start of the TPST-1495 Phase 2 in collaboration with the NCI and the Cancer Prevention Clinical Trials Network and remain confident in the potential of amezalpat to transform the treatment of first-line HCC and bring meaningful benefit to patients and their families."

Financial Results

Third Quarter 2025

Tempest ended the quarter with $7.5 million in cash and cash equivalents, compared to $30.3 million on December 31, 2024. The decrease was primarily due to cash used in operating activities, offset by $4.1 million in net proceeds from the June 2025 registered direct offering, as well as $2.8 million in net proceeds from the company’s at-the-market offering program.
Net loss and net loss per share for the quarter were $3.5 million and $0.79, respectively, compared to $10.6 million and $5.32, respectively, for the same period in 2024.
Research and development expenses for the quarter were $0.6 million, compared to $7.6 million for the same period in 2024. The $7.0 million decrease was primarily due to a decrease in costs incurred as a result of re-prioritizing efforts towards exploring strategic alternatives.
General and administrative expenses for the quarter were $3.0 million, compared to $3.0 million for the same period in 2024, and were primarily related to consulting and professional services.
Year-to-Date

Cash used in operating activities for the nine months ended September 30, 2025 was $23.2 million.
Net loss and net loss per share for the nine months ended September 30, 2025 were $22.2 million and $5.71, respectively, compared to $28.0 million and $15.48, respectively, for the same period in 2024.
Research and development expenses for the nine months ended September 30, 2025 were $12.1 million, compared to $17.7 million for the same period in 2024. The $5.6 million decrease was primarily due to a decrease in costs incurred as a result of re-prioritizing efforts towards exploring strategic alternatives.
General and administrative expenses for the nine months ended September 30, 2025 were $10.4 million, compared to $10.4 million for the same period in 2024, and were primarily related to employee compensation costs, inclusive of one-time separation costs for employees terminated during the nine months ended September 30, 2025, as well as consulting and professional services.

(Press release, Tempest Therapeutics, NOV 5, 2025, View Source [SID1234659476])

On November 5, 2025 Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine, reported that six abstracts have been accepted for presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting 2025. The meeting is taking place November 5 – 9 at the Gaylord National Convention Center in National Harbor, Maryland.

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"We’re excited to join the oncology community at this year’s meeting and highlight our latest research and progress in advancing the immuno-oncology field," said Ezra Cohen, MD, Chief Medical Officer of Oncology at Tempus. "Our latest findings demonstrate the potential of integrated, data-driven approaches to refine biomarkers, improve prediction of immunotherapy response, and inform the development of next-generation tools for patient stratification."

This year, Tempus will highlight its latest scientific and clinical research findings via six poster presentations.

A novel multi-omic algorithm to predict real-world outcomes among patients with rare, advanced, solid cancers treated with off-label immune checkpoint inhibitors
Date/Time: Friday, November 7, 5:10–6:35 p.m. ET
Location: Exhibit Halls AB
Presentation Number: 157
Summary: This study investigates the utility of the Immune Profile Score (IPS) as a molecular signature to predict the effectiveness of immune checkpoint inhibitor (ICI) therapy in rare, advanced solid cancers. Given the clinical unmet need for rare, heterogeneous cancers, the study evaluated 90 eligible patients from Tempus’ de-identified real-world database who had a rare, advanced solid cancer diagnosis and received off-label ICI treatment, excluding those with high TMB or MSI. Patients were further categorized as IPS-high or IPS-low. The findings demonstrated that IPS-high patients experienced significantly longer overall survival compared to those categorized as IPS-low. Importantly, IPS maintained its prognostic significance across all patient subgroups and clinically relevant confounders. These results support IPS as a pan-cancer biomarker capable of accurately stratifying ICI treatment outcomes and potentially supporting the label expansion of ICIs to various rare cancer types.
MAIT cell abundance within tumors are associated with key clinical characteristics across solid tumors
Date/Time: Friday, November 7, 5:10–6:35 p.m. ET
Location: Exhibit Halls AB
Presentation Number: 133
Summary: An analysis of 190,189 patients, utilizing T-cell receptor (TCR) sequencing data from Tempus’ de-identified real-world database, investigated the prevalence and distribution of mucosal-associated invariant T (MAIT) cells across numerous solid tumor types. The study determined MAIT cell abundance using TCRα chains, with comparisons adjusting for overall T cell infiltration or total TCR’s detected where relevant. MAIT cell abundance was highest in tumors of mucosal origin, such as colorectal and gastroesophageal cancers, and higher MAIT cell levels were statistically significantly in younger patients, males, and non-smokers. Furthermore, the prevalence of MAIT cells showed associations with important clinical and molecular factors, including reduced MAIT cell abundance in PD-L1 high (TPS ≥50%; pan-cancer), microsatellite instability (MSI)-high (pan-cancer and colorectal cancer), and microbial factors such as lower bacterial load (pan-cancer). These findings suggest that MAIT cell prevalence may have important clinical implications and may serve as a promising biomarker and immunotherapy target.
TargetR: Automated multi-omics report framework for target characterization and validation of immunotherapy and targeted therapy candidates across cancers
Date/Time: Friday, November 7; 5:10–6:35 p.m. ET
Location: Exhibit Halls AB
Presentation Number: 1115
Summary: A detailed computational framework, TargetR, was developed by integrating public and real-world multi-omics datasets to accelerate the discovery and validation of immunotherapy targets. This approach unified pharmacologic, genomic, transcriptomic, and proteomic data, utilizing advanced analytics to assess target potential based on criteria such as normal tissue expression, mutational load, and copy number variation (CNV) correlation with expression. Validation of findings can then be performed using Tempus’ de-identified real-world database, which provides clinical features and outcome data. The framework generated an automated, user-friendly report with actionable insights, enabling the identification and prioritization of targets for treatments like bispecific T-cell engagers and CAR-T therapies, thereby supporting the development of next-generation immunotherapies.
A multi-omic immune profile score (IPS) stratifies real-world outcomes of microsatellite stable (MSS) advanced colorectal cancer patients treated with immune checkpoint inhibitors
Date/Time: Saturday, November 8; 5:10–6:35 p.m. ET
Location: Exhibit Halls AB
Presentation Number: 134
Summary: This exploratory study investigated the potential of Tempus’ Immune Profile Score (IPS), a DNA- and RNA-based molecular signature, to act as a predictive biomarker for immune checkpoint inhibitor (ICI) benefit in patients with microsatellite stable (MSS) advanced colorectal cancer (CRC). Tempus’ de-identified real-world database was utilized to identify 46 eligible MSS CRC patients who received an ICI alone or ICI-containing regimen in the third line (3L) or beyond. Using pre-ICI tissue, patients were stratified into IPS-High versus IPS-Low groups. The results demonstrated a clinically meaningful improvement in real-world overall survival (rwOS) for the IPS-High group compared to the IPS-Low group. Furthermore, a comparison of IPS risk stratification on ICI therapy versus prior non-ICI regimen provided additional insight about IPS’s utility as an ICI-specific biomarker. This hypothesis-generating data address an unmet need for patients whom an ICI therapy and predictive biomarker are urgently needed.
Ultrahigh tumor mutational burden (TMB) is associated with improved survival outcomes in patients (Pts) treated with immune checkpoint inhibitors (ICIs)
Date/Time: Saturday, November 8, 2025; 5:10–6:35 p.m. ET
Location: Exhibit Halls AB
Presentation Number: 136
Summary: This research evaluates the prognostic value of defining an "ultrahigh" tumor mutational burden (TMB) threshold (≥40 mutations/MB) compared to the standard 10 mt/MB cutoff for patients receiving immune checkpoint inhibitor (ICI) therapy. Using Tempus Lens, the research team defined a cohort of 17,449 patients with five different cancer types (melanoma, lung, GI, non-melanoma skin, and uterine) from Tempus’ de-identified multimodal database. The analysis sought to compare real-world objective response rates (rwORR) and overall survival (rwOS) across low, high, and ultrahigh TMB groups. The findings indicate that patients in the ultrahigh TMB group experience significantly improved clinical outcomes, including enhanced rwORR and better rwOS. This ultrahigh TMB status is also linked to a distinct tumor microenvironment, specifically showing a higher degree of regulatory T cell and myeloid cell infiltration, suggesting that ultrahigh TMB may serve as a novel marker for predicting ICI responsiveness.
Impact of androgen receptor mutations on immune infiltration in castration resistant prostate cancer
Date/Time: Saturday, November 8; 5:10–6:35 p.m. ET
Location: Exhibit Halls AB
Presentation Number: 140
Summary: A detailed analysis using Tempus’ de-identified real-world database examined the relationship between androgen receptor (AR) alterations and the immune microenvironment in 1,556 patients with castration-resistant prostate cancer (CRPC). The study specifically investigated AR mutations, amplifications, and ARv7 splicing detected via DNA (Tempus xT) and RNA (Tempus xR) sequencing. Over half of the CRPC patients exhibited these AR alterations, which were associated with significantly decreased immune infiltration and reduced expression of key immunotherapy targets like PD−1, PD−L1, and CTLA−4. Regression analysis confirmed this link to decreased immune infiltration was independent of tumor mutational burden (TMB) and tumor purity. These findings suggest that AR mutations contribute to a reduced immune response, potentially serving as a mechanism of resistance to treatment, and underscore the necessity of using AR status to stratify CRPC patients for immunotherapy.

(Press release, Tempus, NOV 5, 2025, View Source [SID1234659493])

On November 5, 2025 Foghorn Therapeutics Inc. (Nasdaq: FHTX), a clinical-stage biotechnology company pioneering a new class of medicines that treat serious diseases by correcting abnormal gene expression, reported a financial and corporate update in conjunction with the Company’s 10-Q filing for the quarter ended September 30, 2025. The Company also announced that Chief Financial Officer, Kristian Humer, will be departing to pursue another opportunity.

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"This quarter marked continued execution across our portfolio, reinforcing our leadership in developing novel precision therapies with broad applicability across cancers," said Adrian Gottschalk, President and Chief Executive Officer of Foghorn. "FHD-909, in collaboration with Lilly, is advancing in a Phase 1 dose escalation trial for the treatment of SMARCA4-mutated cancers with a focus on NSCLC. Based on our preclinical monotherapy and combination data, we are enthusiastic about the development of FHD-909 with the goal of developing it as a front-line therapy in NSCLC. Our strategic collaboration with Lilly provides the necessary strategic and financial resources to develop FHD-909."

Mr. Gottschalk continued, "Momentum is strong for our wholly-owned, first-in-class selective degrader programs targeting CBP, EP300 and ARID1B with program updates highlighted during our recent virtual investor event. Our Selective CBP degrader, with potential in ER+ breast cancer, entered non-GLP toxicology studies in Q4 2025 and is advancing towards IND in 2026, and our Selective EP300 degrader continues to show broad spectrum efficacy across hematological malignancies and favorable tolerability in preclinical studies, differentiating it from dual CBP/EP300 approaches. Our Selective ARID1B degrader is progressing towards in vivo proof-of-concept in 2026 with potential in up to 5% of all solid tumors including endometrial, gastric, gastroesophageal junction, bladder and non-small cell lung cancer. Backed by our strong balance sheet and a cash runway into 2028, we are focused on delivering breakthrough therapies that harness the broad therapeutic potential of protein degradation and chromatin regulation. Finally, I want to thank Kristian for his leadership and commitment during his time at Foghorn. He has been a valued member of the team, and I wish him well in his future endeavors."

Program Overview and Upcoming Milestones

FHD-909 (LY4050784). FHD-909 is a first-in-class oral SMARCA2 selective inhibitor that has demonstrated in preclinical studies to have high selectivity over its closely-related paralog SMARCA4, two proteins that are the catalytic engines across all forms of the BAF complex. Selectively blocking SMARCA2 activity is a promising synthetic lethal strategy intended to induce tumor death while sparing healthy cells. SMARCA4 is mutated in up to 10% of NSCLC alone and implicated in a significant number of solid tumors.
•Phase 1 trial enrolling well. Enrollment in the first-in-human Phase 1 multi-center trial of FHD-909, with NSCLC as the primary target population, is progressing well and the study remains on track.
•Synergistic preclinical data of FHD-909 in combination with pembrolizumab and KRAS inhibitors. Preclinical data demonstrates enhanced anti-tumor activity of FHD-909 in combination with standard-of-care (SoC) chemotherapies, anti-PD-1 pembrolizumab and several novel KRAS inhibitors in NSCLC animal models. The combination data will inform further development plans of FHD-909.

Ongoing strategic collaboration with Lilly. Foghorn is collaborating with Lilly to develop novel oncology medicines, including a U.S. 50/50 U.S. co-development and co-commercialization agreement for its selective SMARCA2 oncology program that includes both a selective inhibitor and a selective degrader, as well as an additional undisclosed oncology target. The collaboration also includes three discovery programs.

Selective CBP degrader program. Foghorn’s Selective CBP degrader selectively targets CBP, an acetyltransferase closely related to EP300 designed to target a synthetic relationship in EP300-mutated cancers, which includes endometrial, cervical, ovarian, bladder and colorectal cancer. Attempts to selectively drug CBP have been challenging due to the high level of similarity between the two proteins, while dual inhibition of CBP/EP300 has been associated with dose-limiting toxicities. CBP lineage dependencies are also established in several cancers, including ER+ breast cancer.
•Selective CBP degrader program, IND-ready anticipated in 2026. In October 2025, preclinical data for Selective CBP degrader with potential in EP300-mutated cancers and in ER+ breast cancer was presented during a Foghorn virtual investor event which included:
•Highly potent and selective lead candidate CBPd-171 advancing to dose range finding toxicology studies in Q4 2025
•Anti-tumor activity in EP300 mutant solid tumors and in CBP dependent cancers, including promising potential in ER+ breast cancer
•No significant impact on platelet counts and megakaryocytes spared with CBPd-171
•Long Acting Injectable (LAI) formulation optimized for subcutaneous injection weekly or every other week for convenient administration
Selective EP300 degrader program. Foghorn is developing a Selective EP300 degrader for the treatment of hematological malignancies and prostate cancer. Attempts to selectively drug EP300 have been challenging due to the high level of similarity between EP300 and CBP, while dual inhibition of CBP/EP300 has been associated with dose limiting toxicities. EP300 lineage dependencies are established in multiple myeloma (MM) and diffuse large b-cell lymphoma (DLBCL).
•Selective EP300 Degrader program, with a focus in MM and DLBCL, IND-enabling studies expected in 2026. In October 2025 Foghorn presented efficacy and safety of Selective EP300 degraders in preclinical models of hematological malignancies which included:
•Broad anti-tumor activity in over 70% of all heme sub-lineages tested
•VHL based selective degrader shows impressive efficacy in MM without hematological toxicities including thrombocytopenia
•EP300 degraders show full efficacy in IMiD-resistant MM cell lines
•Tolerability profile with widespread potential for combinations
ARID1B degrader program. Foghorn’s Selective ARID1B degrader selectively targets and degrades ARID1B in ARID1A-mutated cancers. ARID1A is the most mutated subunit in the BAF complex and amongst the most mutated proteins in cancer. These mutations lead to a dependency on ARID1B in several types of cancer, including endometrial, gastric, gastroesophageal junction, bladder and NSCLC. Attempts to selectively drug ARID1B have been challenging because of the high degree of similarity between ARID1A and ARID1B and the fact that ARID1B has no enzymatic activity to target. ARID1B is a major synthetic lethal target implicated in up to 5% of all solid tumors.
•Selective ARID1B degrader program advancing towards in vivo proof of concept in 2026. In October 2025, data for Selective ARID1B degrader was presented at the TPD and Induced Proximity Summit and during a Foghorn virtual investor event which included:
•Developed VHL and cereblon based bifunctional degraders with potential for oral delivery
•Selective degradation of ARID1B achieved
•Modulation of downstream target genes following ARID1B degradation

Degrader Platform. Foghorn continues to advance its degrader platform with investments in novel ligases, long-acting injectables, oral delivery, and induced proximity.

Corporate Update

Leadership. Chief Financial Officer, Kristian Humer, will be departing from the company, with his last day being November 14, 2025. A formal search for a successor has begun.

Third Quarter 2025 Financial Highlights

•Collaboration Revenue. Collaboration revenue was $8.2 million for the three months ended September 30, 2025, compared to $7.8 million for the three months ended September 30, 2024. The increase was driven by the continued advancement of programs under the Lilly Collaboration Agreement.

•Research and Development Expenses. Research and development expenses were $20.0 million for the three months ended September 30, 2025, compared to $24.7 million for the three months ended September 30, 2024. The decrease is attributed to a decrease in FHD-286 costs, decreases in personnel-related costs, early development and other research external costs and facilities and IT-related expenses, partially offset by an increase in Lilly-partnered programs.

•General and Administrative Expenses. General and administrative expenses were $6.7 million for the three months ended September 30, 2025, compared to $7.0 million for the three months ended September 30, 2024. This decrease was primarily due to lower facilities and IT related expenses.

•Net Loss. Net loss was $15.8 million for the three months ended September 30, 2025, compared to a net loss of $19.1 million for the three months ended September 30, 2024.

•Cash, Cash Equivalents, and Marketable Securities. As of September 30, 2025, the Company had $180.3 million in cash, cash equivalents, and marketable securities, providing cash runway into 2028.

About FHD-909
FHD-909 (LY4050784) is a potent, first-in-class, allosteric, and orally available small molecule that selectively inhibits the ATPase activity of SMARCA2 (BRM) over its closely related paralog SMARCA4 (BRG1), two proteins that are the catalytic engines across all forms of the BAF complex, one of the key regulators of the chromatin regulatory system. In preclinical studies, tumors with mutations in SMARCA4 rely on SMARCA2 for their survival. FHD-909 has shown significant anti-tumor activity across multiple SMARCA4-mutant lung tumor models.

(Press release, Foghorn Therapeutics, NOV 5, 2025, View Source [SID1234659461])