Foghorn Therapeutics Highlights January Equity Financing, Program Progress and Strategic Objectives for 2026

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."

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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


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


No impact on platelet counts and spared megakaryocytes 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 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


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

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:


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

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])

Nona Biosciences Enters into Collaboration Agreement with Link Cell Therapies to Advance CAR-T Cell Therapies

On January 9, 2026 Nona Biosciences ("Nona"), a global biotechnology company advancing biologics discovery through innovative technology platforms, reported that it has entered into a multi-target antibody discovery collaboration with Link Cell Therapies. This collaboration will leverage Nona’s proprietary fully human HCAb Harbour Mice platform and its innovative direct CAR-function-based HCAb library screening platform, NonaCarFx, to generate novel CAR-T cell therapy candidates.

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The fully human heavy chain-only antibodies (HCAbs) generated from Nona’s HCAb Harbour Mice platform provide an ideal modality for CAR-based cell therapies. Unlike traditional methods, fully human HCAbs have the potential to significantly reduce immunogenicity. Their compact size, simplified structure, and precisely calibrated binding properties offer enhanced versatility in CAR design. In the rapidly evolving field of cell therapy, fully human HCAbs present a promising approach to unlock the next wave of therapeutic innovation.

Dr. Di Hong, Chief Executive Officer of Nona Biosciences, commented, "We are pleased to collaborate with Link Cell Therapies to advance the next generation of CAR-T therapies. By combining Nona’s HCAb Harbour Mice and NonaCarFx platforms with Link Cell Therapies’ expertise in cell therapy, we aim to accelerate the discovery of differentiated candidates with the potential to address both solid and hematologic malignancies."

Dr. Mark Wallet, Chief Science Officer of Link Cell Therapies, commented, "At Link Cell Therapies, we are building a new generation of chimeric antigen receptor (CAR)-T cell therapies to treat solid tumors using a logic-gated approach that precisely discriminates between malignant and healthy cells. While the LINK CAR signaling technology is the backbone of our logic-gating strategy, a CAR molecule is only as good as its antibody domains. We are pleased to be working with Nona Biosciences to discover novel human HCAbs to pair with the LINK CARs."

(Press release, Nona Biosciences, JAN 9, 2026, View Source [SID1234661899])

Orca Bio Announces $250M in Aggregate Financing in Preparation for Potential Commercialization

On January 9, 2026 Orca Bio, a late-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, reported the completion of a Series F financing round in December 2025 led by Lightspeed Venture Partners. With $250M in new equity capital from its two most recent financing rounds, along with a 2025 amendment to its Silicon Valley Bank credit facility providing up to $100M in additional liquidity, Orca Bio possesses the financial strength to scale its commercial operations and advance its clinical pipeline.

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The proceeds will be used to ensure commercial readiness as the company approaches the April 6, 2026 Prescription Drug User Fee Act (PDUFA) target action date for Orca-T, Orca Bio’s lead investigational allogeneic T-cell immunotherapy. The funding will help strengthen the company’s infrastructure to support future commercial scale, including the addition of East Coast manufacturing capacity to complement its Sacramento, CA operations. The capital will also support the accelerated advancement of Orca Bio’s pipeline across multiple clinical programs designed to expand treatment to more patients in need.

"Our financial position is a powerful validation of Orca-T’s transformative potential and reflects our commitment to pioneering a new standard in cell therapy," said Nate Fernhoff, Ph.D., co-founder and chief executive officer at Orca Bio. "With the resources and infrastructure now in place, we are uniquely positioned to bring our first high-precision therapy to leukemia patients in the U.S. This milestone not only solidifies our anticipated commercial launch but also provides the runway to advance our promising pipeline as we seek to redefine treatment across multiple life-threatening blood cancer and autoimmune diseases."

In parallel to commercialization efforts, Orca Bio remains focused on advancing its pipeline of high-precision cell therapies. The company progressed two clinical programs designed to evaluate Orca-T and Orca-Q in both the reduced intensity conditioning (RIC) and nonmyeloablative (NMA) settings for patients who may not be candidates to receive a traditional myeloablative conditioning (MAC) regimen.

"While myeloablative conditioning offers the best chance to eradicate disease with a traditional allogeneic stem cell transplant, the high toxicity levels carry significant risks, particularly for older patients or those with co-morbidities," said Scott McClellan, M.D., Ph.D., chief medical officer at Orca Bio. "Less intensive conditioning regimens are safer for patients who are not candidates for myeloablative conditioning. Through these new studies, we aim to evaluate if Orca-T and Orca-Q can bring safer, curative interventions to a broader population of blood cancer patients."

SERENE-T Phase 2 Study: SERENE-T (NCT07216443) is a new multicenter, open-label Phase 2 trial evaluating the safety, tolerability and efficacy of Orca-T in patients with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) undergoing RIC or NMA. The overall survival (OS), another secondary endpoint, was 93.7% (95% CI: 86%, 97%) in the Orca-T arm and 83.2% (95% CI: 73%, 90%) in the alloHSCT arm (HR 0.49; p=0.11823).
Expanded Phase 1b Study of Orca-Q: The first patients have been treated in the expanded Phase 1b study (NCT03802695​) which now includes three additional cohorts of patients receiving RIC or NMA with either matched related or unrelated, 7/8 mismatched unrelated or haploidentical related donors. Orca-Q is Orca Bio’s second-generation investigational allogeneic T-cell immunotherapy for patients with AML, MDS or mixed phenotype acute leukemia (MPAL). The cumulative incidence of non-relapse mortality (NRM) was 3.4% (95% CI: 0.9%, 8.8%) for Orca-T versus 13.2% (95% CI: 6.8%, 21.6%) for alloHSCT (HR 0.27 [95% CI: 0.08, 0.93]; p=0.03 in a post hoc analysis).

Both studies are now enrolling with plans to open at additional centers across the U.S. For more information, visit ClinicalTrials.gov.

(Press release, Orca Bio, JAN 9, 2026, View Source;utm_medium=rss&utm_campaign=orca-bio-announces-250m-in-aggregate-financing-in-preparation-for-potential-commercialization [SID1234661900])

PDS Biotech Announces FDA Alignment on use of Progression Free Survival (PFS) as Primary Endpoint

On January 9, 2026 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, reported that the Company has submitted a protocol amendment to the U.S. Food & Drug Administration ("FDA") for its Phase 3 VERSATILE-003 clinical trial. The proposed amendment to the VERSATILE-003 Phase 3 trial changes the PFS endpoint to a primary endpoint that can be evaluated earlier with significant statistical power, potentially providing the basis for accelerated approval of PDS0101. Median overall survival (mOS) remains the primary endpoint for full approval as originally recommended by FDA.

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The submission follows a constructive Type C meeting held with the FDA in December 2025 to discuss the proposed accelerated approval pathway for PDS0101 in HPV16-positive recurrent and/or metastatic Head and Neck Cancer. The amendment is supported by positive final results from the Company’s VERSATILE-002 trial, which showed promising mOS and durable PFS.

"Submission of the amended protocol is an exciting next step in our mission to make this promising treatment available to patients in need," said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. "We believe that including PFS as a primary endpoint offers an important opportunity to shorten the duration of VERSATILE-003. The amendment retains mOS and safety as requirements for full FDA approval, and based on the dialogue we had with the agency in December, we are confident that we have a pathway to potentially accelerate our regulatory submission."

(Press release, PDS Biotechnology, JAN 9, 2026, View Source [SID1234661901])

Corporate overview

On January 9, 2026 AnaptysBio presented its corporate presentation.

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(Presentation, AnaptysBio, JAN 9, 2026, View Source [SID1234661887])