FORE Biotherapeutics Raises $38 Million in Series D-2 Financing for the Continued Advancement of Plixorafenib

FORE生物治疗公司筹集3800万美元D-2轮融资，持续推进Plixorafenib的发展

Financing extends Company’s cash runway beyond important clinical milestones anticipated beginning in 2H25, supporting the ongoing execution of the FORTE Master Protocol evaluating plixorafenib as a monotherapy in three distinct patient populations

融资延长了公司的现金跑道，超越了预计从2025年下半年开始的重要临床里程碑，支持了FORTE主协议的持续执行，该协议评估了plixorafenib作为单一疗法在三个不同患者群体中的效果。

PHILADELPHIA, May 22, 2025-- FORE Biotherapeutics, a registration stage biotherapeutics company dedicated to developing targeted therapies to treat patients with cancer, today announced a $38 million Series D-2 financing. For this initial close of the Series D-2, leading healthcare dedicated investors participated, including SR One, Medicxi, OrbiMed, HBM Healthcare Investments, Wellington Management, Novartis Venture Fund, Cormorant Asset Management, and 3B Future Health Fund.

费城，2025年5月22日——FORE生物治疗公司，一家专注于开发靶向疗法以治疗癌症患者的注册阶段生物治疗公司，今天宣布完成了3800万美元的D-2轮融资。在此D-2轮的首次交割中，一些领先的专注医疗保健的投资者参与其中，包括SR One、Medicxi、OrbiMed、HBM Healthcare Investments、Wellington Management、Novartis Venture Fund、Cormorant Asset Management和3B Future Health Fund。

This $38 million adds to the $75 million raised as part of the earlier Series D and D-1 financings, for an aggregate total to date of $113 million for this Series D financing..

这笔3800万美元的资金是此前D轮和D-1轮融资中筹集的7500万美元的追加资金，截至目前，D轮融资总额已达1.13亿美元。

“At SR One, our mission is to invest in companies that we believe have the ability to innovate and advance transformational new therapies in areas of high unmet medical need,” said Simeon George, M.D., Chief Executive Officer and Managing Partner at SR One. “Fore Bio is focused on resetting the standard in BRAF driven tumors with a potential first in class paradox breaker with compelling early clinical data that support the potential of plixorafenib monotherapy to address the well-known treatment gaps oncologists face with first- and second-generation BRAF inhibitors.

“在SR One，我们的使命是投资那些我们相信有能力在高度未满足医疗需求的领域创新并推动变革性新疗法的公司，” SR One首席执行官兼管理合伙人Simeon George博士说道。“Fore Bio致力于通过潜在的首个突破性悖论破解药物重新设定BRAF驱动肿瘤的标准，其令人信服的早期临床数据支持了plixorafenib单药治疗可能填补目前第一代和第二代BRAF抑制剂所面临的众所周知的治疗空白。”

We are impressed with the team’s progress to date, excited about the multiple near term data readouts, and are proud to support the continued advancement of plixorafenib.”.

“我们对团队迄今为止的进展印象深刻，对多个近期数据读数感到兴奋，并为继续支持普利索拉非尼的发展感到自豪。”

“This financing is a testament to the hard work of our team in developing plixorafenib, a differentiated, rationally designed BRAF inhibitor for both V600 and non V600 mutations that has already generated compelling data to date. We believe plixorafenib has the potential to overcome the limitations of currently available BRAF inhibitors, representing a multi-billion-dollar market opportunity,” said William Hinshaw, Chief Executive Officer of Fore.

“这笔融资证明了我们团队在开发普利索拉非尼（plixorafenib）方面的辛勤工作，这是一种针对V600和非V600突变的差异化、合理设计的BRAF抑制剂，迄今为止已经产生了令人信服的数据。我们相信普利索拉非尼有潜力克服现有BRAF抑制剂的局限性，代表着一个价值数十亿美元的市场机会，”Fore首席执行官威廉·欣肖（William Hinshaw）表示。

“We are grateful for the continued support of this highly regarded investor syndicate and their confidence in both the Fore Bio team and plixorafenib. With their backing, we are well positioned to continue our capitally efficient execution and make significant strides in delivering the ongoing FORTE Master Protocol as we look to multiple anticipated interim analyses and clinical data supporting potential registration under the accelerated approval pathway with FDA submissions potentially at the end of next year.”.

“我们非常感谢这个备受推崇的投资者集团的持续支持，以及他们对Fore Bio团队和Plixorafenib的信任。在他们的支持下，我们有能力继续以资本高效的方式执行战略，并在推进FORTE主协议方面取得重大进展。我们期待多项预期的中期分析和临床数据，这些数据将支持潜在的加速审批通道注册，FDA提交可能在明年年底进行。”

Proceeds from the financing will be used to advance the registration-intended FORTE Master Protocol, 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 BRAF V600 Recurrent Primary Central Nervous System (CNS) Tumors, Rare BRAF V600 Mutated Solid Tumors and Solid Tumors with BRAF Fusions..

融资所得将用于推进旨在注册的FORTE主协议，这是一项全球性的二期临床试验，包含四个子协议组，评估Plixorafenib在不同患者群体中的应用。目前正在评估的三个单药治疗适应症是BRAF V600复发性原发中枢神经系统（CNS）肿瘤、罕见BRAF V600突变实体瘤和具有BRAF融合的实体瘤。

2025 Strategic Objectives and Anticipated Milestones

2025年战略目标与预期里程碑

Fore Bio is anticipating interim analyses to occur in 2025 across three monotherapy indications being evaluated in the FORTE Master Protocol:

Fore Bio预计将在2025年对FORTE主方案中评估的三种单药治疗适应症进行中期分析：

BRAF V600 Primary Recurrent CNS Tumors: In this cohort, up to approximately 50 patients with BRAF V600 primary recurrent CNS tumors will be treated with plixorafenib. The primary endpoints of the study are overall response rate (ORR) and median duration of response (mDOR). An interim efficacy analysis from the first 25 evaluable patients is anticipated to be conducted in the third quarter of 2025.

BRAF V600 原发复发性中枢神经系统肿瘤：在此队列中，将有多达约50名BRAF V600原发复发性中枢神经系统肿瘤患者接受普利索拉非尼治疗。研究的主要终点是总体缓解率（ORR）和中位缓解持续时间（mDOR）。预计将在2025年第三季度对前25名可评估患者进行中期疗效分析。

Pending a positive recommendation from the data monitoring committee, topline data from this trial would be anticipated in the second half of 2026. The company anticipates that this trial, with sufficient demonstration of safety and efficacy, would enable the submission of a New Drug Application (NDA) to the U.S.

待数据监测委员会给出积极建议后，预计将在2026年下半年获得该试验的初步数据。公司预计，这项试验在充分证明安全性和有效性后，将能够向美国提交新药申请（NDA）。

Food and Drug Administration (FDA) under the Accelerated Approval pathway. In a previously conducted Phase 1/2 study of patients with MAPK inhibitor naïve BRAF V600 primary recurrent CNS tumors (n=9), plixorafenib monotherapy demonstrated a 67% ORR and a mDOR of 13.9 months, along with a favorable tolerability profile..

美国食品药品监督管理局（FDA）加速批准途径。在之前进行的一项针对MAPK抑制剂初治的BRAF V600原发性复发性中枢神经系统肿瘤患者（n=9）的1/2期研究中，Plixorafenib单药治疗显示出67%的客观缓解率（ORR）和13.9个月的中位缓解持续时间（mDOR），且耐受性良好。

Rare BRAF V600 Mutated Solid Tumors: In this cohort, up to approximately 75 patients with rare BRAF V600 mutated solid tumors will be treated with plixorafenib. The primary endpoints of the study are ORR and median duration of response mDOR. An interim efficacy analysis from the first 25 evaluable patients is anticipated to be conducted in the fourth quarter of 2025.

罕见BRAF V600突变实体瘤：在此队列中，将有多达约75名罕见BRAF V600突变实体瘤患者接受Plixorafenib治疗。研究的主要终点是客观缓解率（ORR）和中位缓解持续时间（mDOR）。预计将在2025年第四季度对前25名可评估患者进行中期疗效分析。

In a previously conducted Phase 1/2 study of patients with MAPK inhibitor naïve BRAF V600 mutated solid tumors (n=24), plixorafenib monotherapy demonstrated a 42% ORR and a mDOR of 17.8 months, along with a favorable tolerability profile..

在之前进行的一项针对MAPK抑制剂初治的BRAF V600突变实体瘤患者（n=24）的1/2期研究中，普利索拉非尼单药治疗显示出42%的客观缓解率（ORR）和17.8个月的中位缓解持续时间（mDOR），且耐受性良好。

Advanced Solid Tumors with BRAF Fusions: In this cohort, up to approximately 75 patients with advanced solid tumors with non-V600 BRAF fusions will be treated with plixorafenib. The primary endpoints of the study are ORR and median duration of response mDOR. An interim efficacy analysis from the first 25 evaluable patients is anticipated to be conducted in the fourth quarter of 2025.

携带BRAF融合的晚期实体瘤：在此队列中，将有约75名携带非V600 BRAF融合的晚期实体瘤患者接受plixorafenib治疗。研究的主要终点是客观缓解率（ORR）和中位缓解持续时间（mDOR）。预计将在2025年第四季度对前25名可评估患者进行中期疗效分析。

In a previously conducted Phase 1/2 study of adults with advanced solid tumors with BRAF fusions (n=14), plixorafenib monotherapy results in one complete response (with a DOR of 67.4 months), one partial response and 7 stable disease, along with a favorable tolerability profile..

在之前进行的一项针对携带BRAF融合的晚期实体瘤成人患者（n=14）的1/2期研究中，普利索拉非尼单药治疗带来了1例完全缓解（缓解持续时间为67.4个月）、1例部分缓解和7例疾病稳定，同时表现出良好的耐受性。

Recent and Upcoming Medical Meeting Presentations

近期和即将举行的医学会议报告

AACR 2025: In April 2025, Fore presented new circulating tumor DNA (ctDNA) results from a previously completed plixorafenib clinical trial and presented the basket study design for the ongoing global Phase 2 FORTE clinical trial at the American Association for Cancer Research (AACR) Annual Meeting 2025.

AACR 2025：2025年4月，Fore在2025年美国癌症研究协会（AACR）年会上展示了此前完成的Pli xorafenib临床试验中新的循环肿瘤DNA（ctDNA）结果，并介绍了正在进行的全球二期FORTE临床试验的篮式研究设计。

Results from the plasma ctDNA analysis of over 70 plixorafenib-treated patients demonstrated a high concordance between changes in ctDNA and tissue biopsy of several BRAF mutations. The correspondence shown between changes in ctDNA and tumor size across tumor types suggests that ctDNA may be a viable surrogate marker for monitoring disease.

对70多名接受普利索拉非尼治疗的患者进行的血浆ctDNA分析结果显示，ctDNA与几种BRAF突变的组织活检变化之间具有高度一致性。ctDNA变化与各种肿瘤类型的肿瘤大小之间的对应关系表明，ctDNA可能是一个可行的监测疾病的替代标志物。

Compared to acquired mutations driving resistance to early generation BRAF inhibitors, no new mutations in MAPK pathway genes were found following plixorafenib treatment, supporting the dimer–breaker property and novel mechanism of action of plixorafenib from the early generation BRAF inhibitors..

相比于导致对早期BRAF抑制剂产生抗性的获得性突变，在使用普利索拉非尼治疗后，未发现MAPK通路基因中的新突变，这支持了普利索拉非尼作为二聚体破坏剂的特性和不同于早期BRAF抑制剂的新作用机制。

ASCO 2025: At the upcoming 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 30 - June 3 in Chicago, Fore will present the master protocol design of the ongoing global Phase 2 FORTE clinical trial.

ASCO 2025：在即将于2025年5月30日至6月3日在芝加哥举行的美国临床肿瘤学会（ASCO）年会上，Fore将展示正在进行的全球二期FORTE临床试验的主方案设计。

About FORE Biotherapeutics

关于FORE生物治疗公司

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 1st and 2nd generation BRAF inhibitors.

Fore是一家专注于肿瘤学的注册阶段公司，致力于开发创新疗法，为最难治疗的癌症患者提供更好的治疗效果。该公司的主要资产plixorafenib（FORE8394；以前称为PLX8394）是一种V600和非V600 BRAF抑制剂，通过合理设计具有首创机制，旨在解决第一代和第二代BRAF抑制剂的治疗空白。

Plixorafenib has demonstrated single-agent efficacy signals across a variety of tumor types with a manageable safety profile in a Phase 1/2a clinical trial of over 100 patients and is currently enrolling patients in FORTE, a global registrational basket trial to support three distinct indications. For more information, please visit www.fore.bio or follow us on X and LinkedIn..

Plixorafenib 在一项包含 100 多名患者的 1/2a 期临床试验中，展示了在多种肿瘤类型中的单药疗效信号，并具有可管理的安全性特征，目前正在进行全球注册篮式试验 FORTE，以支持三种不同的适应症。欲了解更多信息，请访问 www.fore.bio 或关注我们的 X 和 LinkedIn。

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联系人：

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投资者和媒体：

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212.600.1902 | ForeBio@argotpartners.com

212.600.1902 | ForeBio@argotpartners.com