On January 10, 2026 Pfizer Inc. (NYSE: PFE) reported positive results from Cohort 3, a separate randomized cohort of the pivotal BREAKWATER trial, evaluating BRAFTOVI (encorafenib) in combination with cetuximab (marketed as ERBITUX) and FOLFIRI (fluorouracil, leucovorin, and irinotecan) in patients with previously untreated metastatic colorectal cancer (mCRC) with a BRAF V600E mutation. At the time of this analysis, the BRAFTOVI combination regimen with FOLFIRI and cetuximab demonstrated a clinically meaningful and statistically significant improvement in confirmed objective response rate (ORR) assessed by blinded independent central review (BICR) compared to patients receiving standard-of-care treatment FOLFIRI with or without bevacizumab (64.4% vs 39.2%, odds ratio =2.76, p=0.001). These data will be presented today in an oral presentation (Abstract 13) at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal (ASCO GI) Cancers Symposium and highlighted in the ASCO (Free ASCO Whitepaper) GI official press program.

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"These results represent a great advance for patients with BRAF V600E-mutant metastatic colorectal cancer. We’ve seen this approach significantly increase the response compared to FOLFIRI with or without bevacizumab, and these responses were rapid and durable," said Scott Kopetz, M.D., Ph.D., FACP, Professor and Deputy Chair of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center and co-principal investigator of the BREAKWATER trial. "The trial supports the potential for another chemotherapy backbone option that may be paired with encorafenib plus cetuximab in this patient population."

The estimated median duration of response as assessed by BICR was not estimable with BRAFTOVI plus cetuximab and FOLFIRI (95% Confidence Interval [CI]: not estimable [NE]-NE) or with FOLFIRI with or without bevacizumab (95% CI: 7.0 months-NE). Of patients on BRAFTOVI plus cetuximab and FOLFIRI, 57.4% had a response lasting 6 months or longer, compared to 34.5% with FOLFIRI with or without bevacizumab.

Overall survival (OS) data were analyzed descriptively (Hazard Ratio [HR]: 0.49, 95% CI: 0.24-1.03; median follow-up of approximately 10 months for both arms). The BREAKWATER trial is ongoing with an estimated completion in 2027.

"These data further strengthen the potential utility of BRAFOTVI for patients with BRAF V600E-mutant metastatic colorectal cancer. The significant improvement in response rates reflects the meaningful clinical benefit of this targeted combination therapy regimen for patients," said Jeff Legos, Chief Oncology Officer, Pfizer. "These results underscore the potential of BRAFTOVI as a standard of care for patients with this aggressive cancer and reflect our commitment to advancing precision medicine options that help tailor treatment based on patients’ needs."

The safety profile of BRAFTOVI in combination with cetuximab and FOLFIRI was consistent with the known safety profile of each respective agent. No new safety signals were identified. The most common side effects (≥15%) were nausea, diarrhea, vomiting, alopecia, anemia, neutrophil count decreased, decreased appetite, fatigue, neutropenia, skin hyperpigmentation, dry skin, asthenia, weight decreased, arthralgia, palmar-plantar erythrodysaesthesia syndrome, rash, white blood cell count decreased, and constipation. Among patients receiving BRAFTOVI in combination with cetuximab and FOLFIRI, 8.5% experienced an adverse reaction that resulted in permanent discontinuation of BRAFTOVI.

BRAFTOVI in combination with cetuximab and FOLFIRI is an investigational regimen and is not currently approved for use. BRAFTOVI in combination with cetuximab and mFOLFOX6 received accelerated approval by the U.S. Food and Drug Administration (FDA) in December 2024 for patients with BRAF V600E -mutant mCRC based on a clinically meaningful and statistically significant improvement in confirmed ORR in treatment-naïve patients, one of the study’s primary endpoints. Continued approval for this indication is contingent upon verification of clinical benefit.

Pfizer is continuing its commitment to help non-scientists understand the latest findings with the development of abstract plain language summaries (APLS) for company-sponsored research being presented, which are written in non-technical language. Those interested in learning more can visit www.Pfizer.com/apls to access the summaries.

About BREAKWATER
BREAKWATER is a Phase 3, randomized, active-controlled, open-label, multicenter trial of BRAFTOVI with cetuximab, alone or in combination with chemotherapy (mFOLFOX6 or FOLFIRI) in participants with previously untreated BRAF V600E-mutant mCRC. Patients were randomized to receive BRAFTOVI 300 mg orally once daily in combination with cetuximab (discontinued after randomization of 158 patients), BRAFTOVI 300 mg orally once daily in combination with cetuximab and mFOLFOX6 (n=236) or mFOLFOX6, FOLFOXIRI, or CAPOX, with or without bevacizumab (control arm) (n=243). The dual primary endpoints for these study groups are ORR and PFS as assessed by BICR. OS is a key secondary endpoint. In Cohort 3, patients were randomized to receive BRAFTOVI 300 mg orally once daily in combination with cetuximab and FOLFIRI (n=73) or FOLFIRI, with or without bevacizumab (control-arm) (n=74). The primary endpoint of Cohort 3 is ORR as assessed by BICR. PFS is a key secondary endpoint; OS is a secondary endpoint.

About Colorectal Cancer (CRC)
CRC is the third most common type of cancer in the world, with approximately 1.8 million new diagnoses in 2022.1 It is the second leading cause of cancer-related deaths.2 Overall, the lifetime risk of developing CRC is about 1 in 24 for men and 1 in 26 for women.2 In the U.S. alone, an estimated 154,270 people will be diagnosed with cancer of the colon or rectum in 2025, and approximately 53,000 are estimated to die from the disease each year.3 For 20% of those diagnosed with CRC, the disease has metastasized, or spread, making it harder to treat, and up to 50% of patients with localized disease eventually develop metastases.4

BRAF mutations are estimated to occur in 8-12% of people with mCRC and are associated with a poor prognosis for these patients.5 The BRAF V600E mutation is the most common BRAF mutation and the risk of mortality in CRC patients with the BRAF V600E mutation is more than double that of patients with no known mutation present.5-7 Despite the high unmet need in BRAF V600E-mutant mCRC, prior to December 20, 2024, there were no approved biomarker-driven therapies specifically indicated for people with previously untreated BRAF V600E-mutant mCRC.8,9

About BRAFTOVI (encorafenib)
BRAFTOVI is an oral small molecule kinase inhibitor that targets BRAF V600E. Inappropriate activation of proteins in the MAPK signaling pathway (RAS-RAF-MEK-ERK) has been shown to occur in certain cancers, including CRC.

Pfizer has exclusive rights to BRAFTOVI in the U.S., Canada, Latin America, Middle East, and Africa. Ono Pharmaceutical Co., Ltd. has exclusive rights to commercialize the product in Japan and South Korea, Medison has exclusive rights to commercialize the product in Israel and Pierre Fabre Laboratories has exclusive rights to commercialize the product in all other countries, including Europe and Asia (excluding Japan and South Korea).

INDICATION AND USAGE
BRAFTOVI (encorafenib) is indicated, in combination with cetuximab and mFOLFOX6, for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved test. This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

BRAFTOVI is also indicated, in combination with cetuximab, for the treatment of adult patients with mCRC with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy.

Limitations of Use: BRAFTOVI is not indicated for treatment of patients with wild-type BRAF CRC.

IMPORTANT SAFETY INFORMATION

Refer to the prescribing information for cetuximab and individual product components of mFOLFOX6 for recommended dosing and additional safety information.

WARNINGS AND PRECAUTIONS

New Primary Malignancies: New primary malignancies, cutaneous and non-cutaneous, can occur. In BEACON CRC (previously treated BRAF V600E mutation-positive mCRC), cutaneous squamous cell carcinoma (cuSCC), including keratoacanthoma (KA), occurred in 1.4% of patients with CRC, and a new primary melanoma occurred in 1.4% of patients who received BRAFTOVI in combination with cetuximab. In BREAKWATER (previously untreated BRAF V600E mutation-positive mCRC) skin papilloma was reported in 2.6%, basal cell carcinoma in 1.3%, squamous cell carcinoma of skin in 0.9%, keratoacanthoma in 0.4% and malignant melanoma in situ in 0.4% of patients who received BRAFTOVI in combination with cetuximab and mFOLFOX6. Perform dermatologic evaluations prior to initiating treatment, every 2 months during treatment, and for up to 6 months following discontinuation of treatment. Manage suspicious skin lesions with excision and dermatopathologic evaluation. Dose modification is not recommended for new primary cutaneous malignancies. Based on its mechanism of action, BRAFTOVI may promote malignancies associated with activation of RAS through mutation or other mechanisms. Monitor patients receiving BRAFTOVI for signs and symptoms of non-cutaneous malignancies. Discontinue BRAFTOVI for RAS mutation-positive non-cutaneous malignancies. Monitor patients for new malignancies prior to initiation of treatment, while on treatment, and after discontinuation of treatment.

Tumor Promotion in BRAF Wild-Type Tumors: In vitro experiments have demonstrated paradoxical activation of MAP-kinase signaling and increased cell proliferation in BRAF wild-type cells exposed to BRAF inhibitors. Confirm evidence of BRAF V600E or V600K mutation using an FDA-approved test prior to initiating BRAFTOVI.

Cardiomyopathy: Cardiomyopathy manifesting as left ventricular dysfunction associated with symptomatic or asymptomatic decreases in ejection fraction, has been reported in patients. Assess left ventricular ejection fraction (LVEF) by echocardiogram or multi-gated acquisition (MUGA) scan prior to initiating treatment, 1 month after initiating treatment, and then every 2 to 3 months during treatment. Safety has not been established in patients with a baseline ejection fraction that is either below 50% or below the institutional lower limit of normal (LLN). Patients with cardiovascular risk factors should be monitored closely. Withhold, reduce dose, or permanently discontinue based on severity of adverse reaction.

Hepatotoxicity: Hepatotoxicity can occur. In BREAKWATER (previously untreated BRAF V600E mutation-positive mCRC), the incidence of Grade 3 or 4 increases in liver function laboratory tests in patients receiving BRAFTOVI in combination with cetuximab and mFOLFOX6 was 2.2% for alkaline phosphatase, 1.3% for ALT, and 0.9% for AST. Monitor liver laboratory tests before initiation of BRAFTOVI, monthly during treatment, and as clinically indicated. Withhold, reduce dose, or permanently discontinue based on severity of adverse reaction.

Hemorrhage: In BEACON CRC (previously treated BRAF V600E mutation-positive mCRC), hemorrhage occurred in 19% of patients receiving BRAFTOVI in combination with cetuximab; Grade 3 or higher hemorrhage occurred in 1.9% of patients, including fatal gastrointestinal hemorrhage in 0.5% of patients. The most frequent hemorrhagic events were epistaxis (6.9%), hematochezia (2.3%), and rectal hemorrhage (2.3%). In BREAKWATER (previously untreated BRAF V600E mutation-positive mCRC), hemorrhage occurred in 30% of patients receiving BRAFTOVI in combination with cetuximab and mFOLFOX6; Grade 3 or 4 hemorrhage occurred in 3% of patients. Withhold, reduce dose, or permanently discontinue based on severity of adverse reaction.

Uveitis: Uveitis, including iritis and iridocyclitis, has been reported in patients treated with BRAFTOVI. Assess for visual symptoms at each visit. Perform an ophthalmological evaluation at regular intervals and for new or worsening visual disturbances, and to follow new or persistent ophthalmologic findings. Withhold, reduce dose, or permanently discontinue based on severity of adverse reaction.

QT Prolongation: BRAFTOVI is associated with dose-dependent QTc interval prolongation in some patients. In BREAKWATER (previously untreated BRAF V600E mutation-positive mCRC), an increase of QTcF >500 ms was measured in 3.6% (8/222) of patients receiving BRAFTOVI in combination with cetuximab and mFOLFOX6. Monitor patients who already have or who are at significant risk of developing QTc prolongation, including patients with known long QT syndromes, clinically significant bradyarrhythmias, severe or uncontrolled heart failure and those taking other medicinal products associated with QT prolongation. Correct hypokalemia and hypomagnesemia prior to and during BRAFTOVI administration. Withhold, reduce dose, or permanently discontinue for QTc >500 ms.

Embryo-Fetal Toxicity: BRAFTOVI can cause fetal harm when administered to pregnant women. BRAFTOVI can render hormonal contraceptives ineffective. Advise females of reproductive potential to use effective nonhormonal contraception during treatment with BRAFTOVI and for 2 weeks after the final dose.

Risks Associated with Combination Treatment: BRAFTOVI is indicated for use as part of a regimen in combination with cetuximab, or in combination with cetuximab and mFOLFOX6. Refer to the prescribing information for cetuximab and individual product components of mFOLFOX6 for additional risk information.

Lactation: Advise women not to breastfeed during treatment with BRAFTOVI and for 2 weeks after the final dose.

Infertility: Advise males of reproductive potential that BRAFTOVI may impair fertility.

ADVERSE REACTIONS

BREAKWATER Trial (previously untreated BRAF V600E mutation-positive mCRC)

Serious adverse reactions occurred in 38% of patients who received BRAFTOVI in combination with cetuximab and mFOLFOX6. Serious adverse reactions in >3% of patients included intestinal obstruction (3.5%) and pyrexia (3.5%).
Fatal gastrointestinal perforation occurred in 0.9% of patients who received BRAFTOVI in combination with cetuximab and mFOLFOX6.
Most common adverse reactions(≥25%, all grades) in the BRAFTOVI with cetuximab and mFOLFOX6 arm compared to the control arm (mFOLFOX6 ± bevacizumab or FOLFOXIRI ± bevacizumab or CAPOX ± bevacizumab) were peripheral neuropathy (62% vs 53%), nausea (51% vs 48%), fatigue (49% vs 38%), rash (31% vs 4%), diarrhea (34% vs 47%), decreased appetite (33% vs 25%), vomiting (33% vs 21%), hemorrhage (30% vs 18%), abdominal pain (26% vs 27%), and pyrexia (26% vs 14%).
Most common laboratory abnormalities(≥10%, grade 3 or 4) in the BRAFTOVI with cetuximab and mFOLFOX6 arm compared to the control arm (mFOLFOX6 ± bevacizumab or FOLFOXIRI ± bevacizumab or CAPOX ± bevacizumab) were: increased lipase (51% vs 25%), decreased neutrophil count (36% vs 34%), decreased hemoglobin (13% vs 5%), decreased white blood cell count (12% vs 7%), and increased glucose (11% vs 2%).
BEACON CRC Trial (previously treated BRAF V600E mutation-positive mCRC)

Most common adverse reactions(≥25%, all grades) in the BRAFTOVI with cetuximab arm compared to irinotecan with cetuximab or FOLFIRI with cetuximab (control) were: fatigue (51% vs 50%), nausea (34% vs 41%), diarrhea (33% vs 48%), dermatitis acneiform (32% vs 43%), abdominal pain (30% vs 32%), decreased appetite (27% vs 27%), arthralgia (27% vs 3%), and rash (26% vs 26%).
Other clinically important adverse reactions occurring in <10% of patients who received BRAFTOVI in combination with cetuximab was pancreatitis.
Most common laboratory abnormalities (all grades) (≥20%) in the BRAFTOVI with cetuximab arm compared to irinotecan with cetuximab or FOLFIRI with cetuximab (control) were: anemia (34% vs 48%) and lymphopenia (24% vs 35%).
DRUG INTERACTIONS

Strong or moderate CYP3A4 inhibitors: Avoid coadministration of BRAFTOVI with strong or moderate CYP3A4 inhibitors, including grapefruit juice. If coadministration is unavoidable, reduce the BRAFTOVI dose.

Strong CYP3A4 inducers: Avoid coadministration of BRAFTOVI with strong CYP3A4 inducers.

Sensitive CYP3A4 substrates: Avoid the coadministration of BRAFTOVI with CYP3A4 substrates (including hormonal contraceptives) for which a decrease in plasma concentration may lead to reduced efficacy of the substrate. If the coadministration cannot be avoided, see the CYP3A4 substrate product labeling for recommendations.

Dose reductions of drugs that are substrates of OATP1B1, OATP1B3, or BCRP may be required when used concomitantly with BRAFTOVI.

Avoid coadministration of BRAFTOVI with drugs known to prolong QT/QTc interval.

(Press release, Pfizer, JAN 10, 2026, View Source [SID1234661926])

On January 9, 2026 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 its strategic objectives for 2026.

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"We are pleased to have raised $50 million in an equity financing, priced at a 30% premium to the closing stock price on January 9, 2026. As part of the financing, we issued premium-priced warrants with an exercise price of 2 and 3 times the issue price. This equity raise represents an important vote of confidence from key biotech investors in our vision and execution," said Adrian Gottschalk, President and Chief Executive Officer of Foghorn. "We continue to execute across our first-in-class pipeline focused on developing new treatment options for cancers with significant unmet need. For FHD-909, our partnered program with Lilly, the Phase 1 dose-escalation trial is on track. The trial is enrolling patients with SMARCA4-mutated cancers, particularly those with NSCLC where prognosis is poor and worsens with each additional line of therapy. We are also making strong progress across our degrader portfolio as we advance our Selective CBP degrader, with promise in ER+ breast cancer, and our Selective EP300 degrader, with potential in hematologic malignancies, toward anticipated Investigational New Drug (INDs) filings. With unique programs across our partnered and proprietary pipeline, we look forward to providing updates during the coming year."

*
Unaudited and estimated.

Corporate Update

Strengthens Balance Sheet with Equity Financing to Advance Pipeline. On January 9, 2026, Foghorn entered into agreements with BVF Partners, Deerfield Management, founding investor Flagship Pioneering and a leading biotech mutual fund for the purchase and sale of 2,030,314 shares of its common stock at a purchase price of $6.71 per share and in lieu of common stock to certain investors, pre-funded warrants to purchase up to an aggregate of 5,421,250 shares of its common stock at a price of $6.7099 per pre-funded warrant, which represents the per share offering price for the common stock less the $0.0001 per share exercise price for each such pre-funded warrant as well as warrants to purchase up to 3,725,782 shares of common stock at an exercise price of $13.42 per share and up to 3,725,782 shares of common stock at an exercise price of $20.13 per share. The purchase price of the shares of common stock to be sold in the offering represents a premium of 30% to the last reported sale price of our common stock on the Nasdaq Global Market on January 9, 2026. (The offering is expected to close on or about January 13, 2026, subject to satisfaction of customary closing conditions). All of the shares of common stock in the offering are to be sold by Foghorn.

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. Across lines of therapy, significant unmet needs remain for patients with SMARCA4 (BRG1)-mutant cancers with both poor response rates and short progression-free survival.

•
Phase 1 trial on track. Enrollment in the first-in-human Phase 1 multi-center trial of FHD-909 is progressing well. The trial in patients with NSCLC as the primary target population is on track, following the dosing of the first patient in October 2024.

•
Synergistic preclinical data of FHD-909 in combination with pembrolizumab and KRAS inhibitors. Preclinical data supports 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.

•
Pending successful Phase 1 dose escalation results, Foghorn and Lilly anticipate evaluating FHD-909 in combination studies in the front-line setting of NSCLC.

Ongoing strategic collaboration with Lilly. Foghorn is collaborating with Lilly to develop novel oncology medicines, including a 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 from Foghorn’s proprietary Gene Traffic Control platform.

Selective CBP degrader program. Foghorn’s Selective CBP degrader selectively targets CBP, an acetyltransferase closely related to EP300. CBP lineage dependencies are established in several cancers, including breast cancer and there is also a synthetic relationship in EP300-mutated cancers, which include 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 degrader program – IND-ready anticipated in 2026. In October 2025, preclinical data for Selective CBP degraders CBP-dependent cancers and ER+ breast cancer was presented during a Foghorn virtual investor event, which included:

•
Highly potent and selective lead candidate CBPd-171 in ongoing dose range finding toxicology studies

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Anti-tumor activity in EP300 mutant solid tumors and in CBP-dependent cancers, including promising potential in ER+ breast cancer

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No impact on platelet counts and spared megakaryocytes with CBPd-171

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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 diffuse large b-cell lymphoma (DLBCL) and multiple myeloma (MM).

•
EP300 degrader program – IND-enabling studies expected in 2026, with a focus in MM and DLBCL. In October 2025, efficacy and safety data of Selective EP300 degraders in preclinical models of hematological malignancies was presented during a Foghorn virtual investor event which included:

•
Broad anti-tumor activity in over 70% of all heme sub-lineages tested

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VHL-based selective degrader shows impressive efficacy in MM without hematological toxicities including thrombocytopenia

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EP300 degraders show full efficacy in IMiD-resistant MM cell lines

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Tolerability profile with widespread potential for combinations

Selective 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.

•
First-in-class Selective ARID1B degrader program advancing towards in vivo proof of concept in 2026. In October 2025, progress for the Selective ARID1B degrader was presented during a Foghorn virtual investor event which included:

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Developed VHL and cereblon based bifunctional degraders with potential for oral delivery

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Selective degradation of ARID1B achieved

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Modulation of downstream target genes following ARID1B degradation

Strong Balance Sheet and Cash Runway.

As of January 13, 2026, the Company expects to have approximately $208.9 million (unaudited) in cash, cash equivalents, and marketable securities, inclusive of proceeds from the recent equity financing, allowing for continued investment in the pipeline and extending cash into the first half of 2028.

The securities described under Corporate Update are being offered by Foghorn pursuant to a shelf registration statement on Form S-3 declared effective by the Securities and Exchange Commission ("SEC") on January 31, 2025. This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, 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. A prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov.

(Press release, Foghorn Therapeutics, JAN 9, 2026, View Source [SID1234661950])

On January 9, 2026 Averna Therapeutics, Inc., a biotechnology company developing novel genomic medicines based on gene insertion technology, reported that Tom Barnes, Ph.D., Chief Executive Officer, will present at the 44th Annual J.P. Morgan Healthcare Conference on Thursday, January 15, 2026, at 10:00 AM PT in San Francisco.

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(Press release, Averna Therapeutics, JAN 9, 2026, View Source [SID1234661912])

On January 9, 2026 Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, SSE: 688796; HKEX: 02315) and Acepodia (6976:TT), reported that the companies have entered into an option and license agreement designed to enable the structured evaluation of bispecific antibody-drug conjugate (BsADC) programs to further advance the development of dual-payload bispecific antibody-drug conjugates (BsAD2Cs).

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The agreement grants Acepodia an option to obtain an exclusive worldwide license from Biocytogen for two BsADC programs. Under the terms of the agreement, Biocytogen is eligible to receive an upfront option fee and, upon Acepodia’s exercise of the option, additional payments including option exercise fees, development, regulatory, and commercial milestone payments, as well as royalties on future product sales. The financial terms of the agreement were not disclosed.

"This new agreement builds upon our recent co-development collaboration with Acepodia, which has focused on the evaluation and selection of leading bispecific antibody and dual-payload ADC candidates," said Dr. Yuelei Shen, President and CEO of Biocytogen. "Based on the preclinical research conducted to date, we believe that the combination of Biocytogen’s RenLite platform with Acepodia’s Antibody-Dual-Drugs Conjugation (AD2C) technology offers a compelling approach for the development of next-generation dual-payload bispecific ADCs."

"This option-based framework allows us to systematically assess how dual-payload conjugation strategies can be applied to bispecific antibody formats," said Sonny Hsiao, Ph.D., Chairman and CEO of Acepodia. "This collaboration reflects our focus on disciplined, data-driven AD2C platform expansion."

The expanded partnership is intended to leverage complementary platform strengths to advance next-generation ADC designs with the potential to improve upon certain limitations observed in conventional ADC programs. The joint team is progressing towards candidate evaluation milestones, with advancement decisions informed by ongoing research results and Acepodia’s internal governance and option exercise criteria.

(Press release, Biocytogen, JAN 9, 2026, View Source [SID1234661911])

On January 9, 2026 The University of Pennsylvania ("Penn"), BioNTech SE ("BioNTech"), and OUP (Osage University Partners) reported the launch of the $50 million Penn-BioNTech Innovative Therapeutics Seed Fund ("PxB Fund"), a dedicated venture capital fund focused on early-stage life science companies originating from Penn. The joint effort will provide additional fuel to advance Penn discoveries into products that benefit patients across the world, following a decade in which the university’s research teams have spawned 45 FDA approvals for transformative vaccines and novel medical treatments such as CAR T cell therapy, and garnered a Nobel Prize and four Breakthrough Prizes for Life Sciences.

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The PxB Fund will provide capital to Penn-founded companies developing novel therapeutics, diagnostics, and research tools, including AI-enabled drug discovery platforms to address serious medical conditions. It is designed to help Penn investigators accelerate the translation of high-potential science from their labs to patients by providing early-stage capital to promising Penn startups. The fund will be managed by OUP, a Philadelphia-based venture capital firm with over $800 million under management that has invested in more than 150 startups commercializing university research, including more than 10 Penn startups.

"Penn has a remarkable track record of creating cutting-edge startups, with recent success stories including Capstan Therapeutics, which has been acquired by AbbVie, and Interius BioTherapeutics, acquired by Kite," said Marc Singer, Managing Partner of OUP. "We have been a partner of Penn and have worked closely with the Penn Center for Innovation (PCI) over many years to promote the Penn entrepreneurial ecosystem. Through the PxB Fund, and with access to BioNTech’s insights, we intend to invest in the next generation of Penn innovations to translate breakthrough science into medicines that can improve patients’ lives."

As part of the launch, Anna Turetsky, PhD has been appointed as General Partner. Dr. Turetsky is an experienced biotech investor and Penn alumnus who has spent her decade-long career backing and advising early-stage therapeutics companies. After earning her PhD in Biophysics at Harvard University, she began her venture career at Lightstone Ventures, where she invested in and helped build multiple successful life science startups. She then launched and led the venture arm of an oncology-focused non-profit, the Mark Foundation, where her investments included work with Penn on Interius BioTherapeutics.

Penn is a global leader in translating academic research into commercial impact, with hundreds of startups formed around Penn intellectual property and a large and growing list of FDA-approved therapies tied to inventions made by its scientists and physicians, including Nobel Prize winning mRNA technology used in some COVID-19 vaccines. The PxB Fund is a strong complement to Penn’s existing commercialization, incubation, and co-investment programs, providing a focused capital pool to lead financing transactions at the earliest stages of company formation.

"Penn’s mission is not only to perform groundbreaking research and generate and disseminate new knowledge, but to ensure that the fruits of those efforts are translated into real-world solutions," said John S. Swartley, PhD, MBA, Chief Innovation Officer of the University of Pennsylvania. "This new fund is reflective of the deep trust and shared vision we have with BioNTech and OUP. It will allow us to move faster and more intentionally to support our faculty and other members of our research community as they build high-impact life science companies here in Philadelphia and beyond. We see this as a major step forward for Penn’s innovation ecosystem and a real boon for patients."

BioNTech, a pioneer in mRNA-based medicines and next-generation immunotherapies, has longstanding scientific and translational ties to Penn. Through the PxB Fund, BioNTech aims to deepen its collaboration with Penn and increase its visibility into emerging therapeutic approaches at the university across a breadth of technologies and modalities.

"BioNTech has a longstanding R&D collaboration with Penn. Groundbreaking work, including in mRNA and immunotherapy, is aligned with our commitment to developing innovative therapeutics for patients with high unmet medical needs," said James Ryan, Ph.D., Chief Business Officer and Chief Legal Officer, BioNTech SE. "By partnering with Penn and OUP on this fund, we will have the opportunity to support the next wave of scientific breakthroughs coming out of the university."

About the PxB Fund

The PxB Fund (Penn BioNTech Innovative Therapeutics Seed Fund) is a $50 million venture capital fund formed by the University of Pennsylvania, BioNTech, and OUP to invest in early-stage life science companies based on Penn intellectual property and/or founded by Penn researchers. The fund focuses on seed and Series A investments in therapeutics, platforms, diagnostics, and research tools emerging from Penn’s faculty and researcher community.

(Press release, BioNTech, JAN 9, 2026, View Source [SID1234661910])