FORE Biotherapeutics Announces Closing of Upsized $67.4 Million Series D-2 Extension Financing and Highlights Recent Plixorafenib Achievements

Target enrollment reached in BRAF V600E primary CNS tumor basket of FORTE study; topline results from this registrational basket anticipated around the end of 2026

PHILADELPHIA--(BUSINESS WIRE)--FORE Biotherapeutics, a registration stage company dedicated to developing targeted therapies to treat patients with cancer, today announced the closing of an upsized Series D-2 extension financing of $67.4 million, bringing the total Series D-2 amount raised to $110 million. The financing was co-led by SR One, Medicxi, and SymBiosis and supported by a syndicate of new investors, including TaiAx, LG Technology Ventures, Primer Ventures and Axil, and all existing investors, including OrbiMed Advisors, HBM Healthcare Investments, Wellington Management, Cormorant Capital, Novartis Venture Fund, Windham Life Science Partners, Samsung and 3B Capital. Proceeds from the financing will be used to support the ongoing late-stage development of plixorafenib, including delivering on the topline data from the recurrent or progressive BRAF V600E primary CNS tumor basket of the FORTE study around the end of 2026, a subsequent regulatory submission, and continued development in additional distinct monotherapy indications including rare BRAF V600 mutated solid tumors and advanced solid tumors with BRAF fusions.

“We are pleased with the progress at Fore this year, which allowed us to expand our investor base with new, quality healthcare investors and are grateful for the continued support from all our existing investors, which reflects their confidence in the potential for plixorafenib to disrupt the BRAF market,” said William Hinshaw, Chief Executive Officer of Fore. “With target enrollment now complete in the primary CNS tumor basket, we look forward to reporting topline data from this basket around the end of 2026. With the recent Breakthrough Therapy Designation granted to plixorafenib, we continue to progress towards a planned regulatory submission in 2027 for BRAF V600E CNS tumors and bringing this novel mechanism and differentiated profile to patients who are in need of improved therapeutic options.”

Plixorafenib Updates

Fore Bio also announced several positive program updates for its ongoing FORTE study demonstrating continued timely execution as well as notable patient-friendly improvements to the protocol:

• Target enrollment of approximately 50 patients has been reached in the BRAF V600E CNS tumor basket of the FORTE study, and topline data from the study is now anticipated around the end of 2026. This basket previously met the pre-specified interim analysis, with the Independent Data Monitoring Committee (IDMC) supporting that the study may continue as planned based on responses assessed by blinded independent central review (BICR), in addition to the IDMC’s ongoing oversight for safety. The company anticipates that the primary analysis of data from this basket, if positive, would enable the submission of a New Drug Application to the U.S. Food and Drug Administration under the Accelerated Approval pathway.
• Based upon the protocol-specified decision rule and available safety and PK data, clearance from the IDMC has been received to enroll patients as young as 8 years of age, compared to a prior age range starting at 10 years old, to align more closely with the observed BRAF-altered patient population including children and young adults in which low-grade gliomas (LGG) and other primary CNS tumors more commonly occur.
• Fore Bio has implemented an improvement to the dosing regimen in the FORTE study to administer plixorafenib with food, on the basis of a recent food effect study. On the basis of this data, and the supportive data from clinical studies showing robust exposures and anti-tumor activity with plixorafenib alone, cobicistat, an approved CYP3A inhibitor designed to serve as a PK booster, will no longer be administered with plixorafenib.

Mr. Hinshaw concluded, “With several key clinical and regulatory catalysts on the horizon, we believe plixorafenib has the potential to meaningfully improve upon the current treatment paradigm, representing a significant opportunity across several BRAF-altered CNS tumor types including high and low grade glial and glioneuronal brain and spinal cord tumors, glioblastomas, and others, in addition to the distinct patient populations currently being evaluated in the FORTE study.”

The company is currently evaluating plixorafenib in two additional monotherapy baskets in the FORTE study, in rare BRAF V600 mutated solid tumors and advanced solid tumors with BRAF fusions, respectively. The company anticipates advancing through multiple clinical and regulatory milestones across the plixorafenib development program throughout 2026 and into 2027.

About the Global Phase 2 FORTE Basket Study

The registration-intended FORTE Master Protocol is a global Phase 2 clinical trial which includes four sub-protocol baskets evaluating plixorafenib in distinct patient populations. The three monotherapy indications currently under evaluation are recurrent or progressive BRAF V600E primary CNS tumors, solid tumors with BRAF fusions and rare BRAF V600 mutated solid tumors. As part of the Bayesian adaptive design of the trial, interim efficacy analyses are conducted in each basket, for which the company reported a positive outcome from the BRAF V600 CNS basket in the third quarter of 2025.

About Plixorafenib

Plixorafenib is a novel BRAF inhibitor, with a unique mechanism of action that functions both as a dimer and paradox breaker, and that has demonstrated a differentiated and compelling monotherapy profile in clinical studies. Plixorafenib received Breakthrough Therapy Designation by the U.S. Food and Drug Administration in April 2026. In a previously conducted Phase 1/2 study in patients with MAPK inhibitor naïve BRAF V600 primary recurrent CNS tumors (n=9), plixorafenib monotherapy demonstrated an ORR of 67% and a clinical benefit rate of greater than 75%. In patients with V600 alterations who were MAPK inhibitor naïve, plixorafenib achieved a 42% response rate with prolonged duration of response (mDOR 17.8 months), with a clinical benefit rate of >70%. Plixorafenib also demonstrated a favorable safety and tolerability profile across tumor types, including relative to existing standard of care treatments for various BRAF altered tumors, with a discontinuation rate due to drug-related adverse events of less than 2%. Fore believes plixorafenib has the potential to overcome the limitations of currently available BRAF inhibitors through its unique mechanism of action targeting BRAF, while avoiding the limitations of the earlier generation BRAF inhibitors that led to rapid recurrence of disease and the need for combination with a MEK inhibitor.

About FORE Biotherapeutics

Fore is a registration stage targeted oncology company dedicated to developing innovative treatments that provide better outcomes for patients with the hardest-to-treat cancers. The Company’s lead asset plixorafenib (FORE8394; formerly PLX8394) is a V600 and non-V600 BRAF inhibitor rationally designed with a first-in-class mechanism to address treatment gaps from 1^st and 2^nd generation BRAF inhibitors. For more information, please visit www.fore.bio or follow us on X and LinkedIn.