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Bolt Biotherapeutics Provides Update on BDC-4182 and Extends Cash Runway into 2027

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Bolt Biotherapeutics (Nasdaq: BOLT) has announced updates regarding its Phase 1 dose escalation study of BDC-4182, their next-generation Boltbody™ ISAC targeting claudin 18.2 for cancer treatment. Due to strong immune responses observed at initial dose levels, the company is modifying the clinical trial protocol to implement step-up dosing, delaying initial clinical data release to Q3 2026.

To preserve capital, Bolt is implementing a 50% workforce reduction, which will extend their cash runway into 2027. The company will maintain focus on advancing BDC-4812 clinically and supporting their ISAC collaborations to enhance shareholder value.

Bolt Biotherapeutics (Nasdaq: BOLT) ha annunciato aggiornamenti riguardo al suo studio di escalation di dose di Fase 1 di BDC-4182, la loro prossima generazione Boltbody™ ISAC mirata a claudin 18.2 per il trattamento del cancro. A causa delle forti risposte immunitarie osservate ai livelli di dose iniziali, l'azienda sta modificando il protocollo dello studio clinico per implementare dosi a gradino, ritardando la pubblicazione iniziale dei dati clinici a Q3 2026.

Per conservare capitale, Bolt sta implementando una riduzione del personale del 50%, che estenderà la sua runway di liquidità fino al 2027. L'azienda manterrà l'attenzione sull'avanzamento clinico di BDC-4812 e sul supporto delle loro collaborazioni ISAC per aumentare il valore per gli azionisti.

Bolt Biotherapeutics (Nasdaq: BOLT) ha anunciado actualizaciones sobre su estudio de escalado de dosis de Fase 1 de BDC-4182, su ISAC Boltbody™ de próxima generación dirigido a claudin 18.2 para el tratamiento del cáncer. Debido a respuestas inmunitarias fuertes observadas en los niveles de dosis iniciales, la empresa está modificando el protocolo del ensayo clínico para implementar un esquema de dosis escalonadas, retrasando la publicación inicial de datos clínicos a Q3 2026.

Para preservar el capital, Bolt está implementando una reducción de plantilla del 50%, lo que extenderá su runway de efectivo hasta 2027. La compañía mantendrá el enfoque en avanzar clínicamente BDC-4812 y en respaldar sus colaboraciones ISAC para aumentar el valor para los accionistas.

Bolt Biotherapeutics (Nasdaq: BOLT)는 차세대 Boltbody™ ISAC으로 claudin 18.2를 표적으로 하는 BDC-4182의 1상 용량 증가 연구에 대한 업데이트를 발표했습니다. 초기 용량 수준에서 강한 면역 반응이 관찰되어, 회사는 임상 시험 프로토콜을 수정하여 점진적 용량 적용(step-up dosing)을 구현하고 2026년 3분기에 초기 임상 데이터 발표를 연기하고 있습니다.

자본 보존을 위해 Bolt는 정원감축 50%를 시행하고 있으며, 이로써 현금 유동성은 2027년까지 늘어날 것입니다. 회사는 임상적으로 BDC-4812의 진행에 집중하고 ISAC 협력을 지원하여 주주 가치를 높이려는 노력을 지속할 것입니다.

Bolt Biotherapeutics (Nasdaq: BOLT) a annoncé des mises à jour concernant son étude de dose-escalation de Phase 1 de BDC-4182, leur ISAC Boltbody™ de nouvelle génération visant la claudine 18.2 pour le traitement du cancer. En raison de fortes réponses immunitaires observées à des niveaux de dose initiaux, l'entreprise modifie le protocole de l'essai clinique pour mettre en œuvre une titration par paliers (step-up dosing), retardant la publication des données cliniques initiales à Q3 2026.

Pour préserver les capitaux, Bolt met en œuvre une réduction de personnel de 50%, ce qui prolongera sa runway de trésorerie jusqu'en 2027. L'entreprise restera axée sur le développement clinique de BDC-4812 et sur le soutien de ses collaborations ISAC afin d'accroître la valeur pour les actionnaires.

Bolt Biotherapeutics (Nasdaq: BOLT) hat Updates zu seiner Phase-1-Dosis-Eskalationsstudie von BDC-4182, ihrem nächsten Boltbody™ ISAC, das auf Claudin 18.2 zur Krebsbehandlung abzielt, bekannt gegeben. Aufgrund starker Immunantworten, die bei den anfänglichen Dosierungsstufen beobachtet wurden, ändert das Unternehmen das klinische Studienprotokoll, um eine Stufen-Dosierung (step-up dosing) zu implementieren, und verzögert die Veröffentlichung der ersten klinischen Daten auf Q3 2026.

Um Kapital zu schonen, führt Bolt eine 50%-ige Reduzierung der Belegschaft durch, wodurch sich die Cash-Runway bis ins Jahr 2027 verlängert. Das Unternehmen wird den Fokus darauf legen, BDC-4812 klinisch voranzutreiben und ihre ISAC-Kollaborationen zu unterstützen, um den Aktionärswert zu erhöhen.

Bolt Biotherapeutics (Nasdaq: BOLT) أعلنت تحديثات بخصوص دراسة زيادة الجرعة في المرحلة 1 لـ BDC-4182، جهاز Boltbody™ ISAC من الجيل التالي المستهدف لـ claudin 18.2 لعلاج السرطان. نظرًا للردود المناعية القوية التي لوحظت عند مستويات الجرعة الأولية، فإنه يتم تعديل بروتوكول التجربة السريرية لتنفيذ جرعات تدريجية، مع تأجيل نشر البيانات السريرية الأولى إلى Q3 2026.

للحفاظ على رأس المال، تنفذ Bolt تقليلًا بنسبة 50% في القوى العاملة، مما سيمدد مسار السيولة حتى عام 2027. ستحافظ الشركة على التركيز على تقدم BDC-4812 سريريًا ودعم تعاوناتها ISAC لتعزيز قيمة المساهمين.

Bolt Biotherapeutics (Nasdaq: BOLT) 已宣布关于其第一阶段剂量爬升研究的更新,针对他们的下一代 Boltbody™ ISAC 的 BDC-4182,靶向癌细胞治疗中的 Claudin 18.2。由于在初始剂量水平观察到强烈的免疫反应,公司正在修改临床试验方案,以实施分步用药(step-up dosing),将初始临床数据的发布推迟至 2026年第三季度

为保存资金,Bolt 将实施 50% 的裁员,这将使其现金跑道延长至 2027 年。公司将继续专注于临床推进 BDC-4812,并支持其 ISAC 合作以提升股东价值。

Positive
  • Strong immune response observed at initial dose levels for BDC-4182
  • Cash runway extended into 2027 through cost reduction measures
  • Protocol modification aligns with successful commercial T-cell engager approaches
Negative
  • Clinical trial data delayed until Q3 2026
  • 50% workforce reduction implemented
  • Protocol modification required for BDC-4182 trial

Insights

Bolt's protocol change for BDC-4182 delays data readout to 2026 while 50% workforce reduction extends cash runway to 2027.

Bolt Biotherapeutics has announced a significant update on its lead clinical candidate BDC-4182, a Boltbody™ ISAC targeting claudin 18.2 for cancer treatment. The company is implementing protocol modifications after observing strong immune responses at initial dose levels, now incorporating a step-up dosing approach similar to what's used for T-cell engagers. This change pushes the timeline for initial clinical data from the Phase 1 dose escalation study to Q3 2026, representing a delay in the development timeline.

Concurrent with this clinical update, Bolt is executing a 50% workforce reduction to extend its cash runway into 2027. This substantial restructuring appears to be a defensive move amid what the CEO describes as "challenging market conditions," allowing the company to conserve capital while focusing resources on advancing BDC-4812 and supporting their existing collaborations.

The step-up dosing modification is scientifically sound - this approach has precedent in commercially successful T-cell engagers and is supported by Bolt's preclinical data. However, the significant workforce reduction suggests the company is implementing a severe strategy to weather extended development timelines. While the cash runway extension into 2027 provides financial stability, this comes at the cost of organizational capacity and potentially slowed development across other pipeline assets. The focus on BDC-4812 and collaborations indicates a narrowing strategic focus to preserve shareholder value through a difficult period.

  • Initial clinical data for BDC-4182 Phase 1 dose escalation study now expected in 3Q 2026
  • Company is implementing a 50% workforce reduction to extend cash runway into 2027

REDWOOD CITY, Calif., Oct. 01, 2025 (GLOBE NEWSWIRE) -- Bolt Biotherapeutics (Nasdaq: BOLT), a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer, today announced an update on the ongoing Phase 1 dose escalation study of BDC-4182, a next-generation Boltbody™ ISAC clinical candidate targeting claudin 18.2, a clinically validated target in oncology. A strong immune response was observed at the initial dose levels and the Company is in the process of modifying the clinical trial protocol to allow for step-up dosing, which has been successfully used commercially for T-cell engagers. BDC-4182 preclinical data supports this approach.

As a result of the update to the clinical trial protocol for BDC-4182, Bolt now expects to report initial clinical data in the third quarter of 2026. To conserve capital and maintain long-term shareholder value, the Company is implementing a workforce reduction of approximately 50%, extending its cash runway into 2027.

“I want to sincerely thank all of our colleagues impacted by this decision. Their commitment and valuable contributions have been essential in developing our novel Boltbody™ ISAC technology and these potential new treatment options for patients with cancer,” said Willie Quinn, President and Chief Executive Officer. “Amid challenging market conditions, our strategic imperative is the clinical advancement of BDC-4812 and the support of our ISAC collaborations to increase shareholder value. We look forward to continuing our mission and to providing updates on BDC-4812 later next year.”

About Bolt Biotherapeutics, Inc.
Bolt Biotherapeutics is a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer. Bolt Biotherapeutics’ pipeline candidates are built on the Company’s deep expertise in myeloid biology and cancer drug development. The Company’s pipeline includes BDC-4182, a next-generation Boltbody™ Immune-Stimulating Antibody Conjugate (ISAC) clinical candidate targeting claudin 18.2. BDC-4182 is currently in a Phase 1 dose escalation trial that includes patients with gastric and gastroesophageal cancer. The Company has strategic collaborations with Genmab and Toray built around the Company’s Boltbody™ Immune-Stimulating Antibody Conjugate (ISAC) platform technology and its expertise in myeloid biology. The Company is seeking to partner its Dectin-2 agonist, BDC-3042, that recently completed a first-in-human Phase 1 dose escalation trial. For more information, please visit https://www.boltbio.com/.

Forward-Looking Statements
This press release contains forward-looking statements about us and our industry that involve substantial risks and uncertainties and are based on our beliefs and assumptions and on information currently available to us. All statements other than statements of historical facts contained in this press release, including statements regarding our ability to partner BDC-3042, the advancement and success of our BDC-4182 clinical trials, the receipt of BDC-4182 initial clinical data in the third quarter of 2026, the anti-tumor potency, safety and tolerability, and characteristics of our product candidates, the initiation of future clinical trials, the potential value of collaborations, and the expected duration of our cash runway into 2027, are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “on track,” “plan,” “potential,” “predict,” “project,” “should,” “will,” or “would,” or the negative of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Forward-looking statements represent our current beliefs, estimates and assumptions only as of the date of this press release and information contained in this press release should not be relied upon as representing our estimates as of any subsequent date. These statements, and related risks, uncertainties, factors and assumptions, include, but are not limited to: the potential product candidates that we develop may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release; such product candidates may not be beneficial to patients or become commercialized; and our ability to maintain our current collaborations and establish further collaborations. These risks are not exhaustive. Except as required by law, we assume no obligation to update these forward-looking statements, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future. Further information on factors that could cause actual results to differ materially from the results anticipated by our forward-looking statements is included in the reports we have filed or will file with the Securities and Exchange Commission, including our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. These filings, when available, are available on the investor relations section of our website at investors.boltbio.com and on the SEC’s website at www.sec.gov.

Investor Relations and Media Contact:
Matthew DeYoung
Argot Partners
(212) 600-1902
boltbio@argotpartners.com


FAQ

When will Bolt Biotherapeutics (BOLT) release initial clinical data for BDC-4182?

Bolt Biotherapeutics expects to release initial clinical data for BDC-4182 in the third quarter of 2026.

How many employees is Bolt Biotherapeutics (BOLT) laying off in 2025?

Bolt Biotherapeutics is implementing a 50% workforce reduction to extend its cash runway into 2027.

What is BDC-4182 targeting in Bolt Biotherapeutics' clinical trial?

BDC-4182 is a next-generation Boltbody™ ISAC targeting claudin 18.2, a clinically validated target in oncology.

How long will Bolt Biotherapeutics' (BOLT) cash runway extend after the workforce reduction?

The workforce reduction will extend Bolt Biotherapeutics' cash runway into 2027.

Why is Bolt Biotherapeutics modifying the BDC-4182 clinical trial protocol?

Bolt is modifying the protocol to implement step-up dosing due to strong immune responses observed at initial dose levels, following an approach successfully used for T-cell engagers.
Bolt Biotherapeutics, Inc.

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