• Expansion of lead KIF18Ai program in lung, head and neck cancers following early positive results

• Genetic biomarker signatures show early correlation with KIF18Ai clinical response

• Company reports encouraging monotherapy expansion data in platinum-resistant ovarian cancer and initiates first combination study with standard-of-care chemotherapies in Q1 2026

• Timothy Bowler, M.D., Ph.D., appointed as Chief Medical Officer

Volastra Therapeutics, a clinical-stage biotechnology company pioneering first-in-class therapies targeting chromosomal instability (CIN) in cancer, today announced a significant expansion of its clinical development program driven by encouraging clinical data from its lead KIF18A inhibitor (KIF18Ai), a key investigational CIN-targeted cancer therapy. The company also highlighted continued advancement across its strategic pipeline and the appointment of Timothy Bowler, M.D., Ph.D., as its new Chief Medical Officer, strengthening its leadership team as it executes on key value-inflection milestones.

“These developments represent a meaningful step forward for Volastra as we continue to build a differentiated oncology company focused on chromosomal instability,” said David Southwell, Chief Executive Officer of Volastra Therapeutics. “The strength of the emerging clinical data from our KIF18Ai program reinforces our conviction in CIN as a compelling therapeutic target and supports the expansion of our clinical strategy. With continued progress across our pipeline and the addition of our highly experienced Chief Medical Officer, we are well-positioned to execute on key upcoming milestones and create long-term value for patients and shareholders.”

In addition to the company’s progress with its KIF18Ai ovarian cancer clinical program:

• Expansion into New Tumor Types: It is also extending its Phase 1/2 program beyond ovarian cancer, with additional efficacy data from expansion cohorts expected in the first half of 2026.

• KIF18Ai Combination Trials: The company is advancing new combination therapy studies with standards of care based on synergistic efficacy with taxanes in preclinical studies. Volastra plans to initiate its first combination trial in the first quarter of 2026, evaluating a KIF18Ai in combination with standard-of-care chemotherapy in patients with ovarian, lung, and breast cancers. Initial safety data are anticipated in the second quarter, with efficacy data expected to emerge in the second half of the year.

• Biomarker Approach: In parallel, the company will continue to advance its biomarker identification strategy to predict KIF18Ai response, with results expected throughout the first half of 2026.

• FDA Regulatory Update: Volastra also anticipates an End-of-Phase meeting with the FDA in the second half of 2026 to discuss potential registrational trials, reflecting the continued clinical momentum of the program.

These initiatives build on VLS-1488’s Phase 1 clinical results and follow the program’s FDA Fast Track designation in platinum-resistant ovarian cancer. To date, more than 120 patients have been treated with VLS-1488, which has been well tolerated across all dose levels with no dose-limiting toxicities observed. The company has demonstrated a clear dose-response across dose levels, with strong early efficacy and a favorable safety profile in platinum-resistant ovarian cancer. Notably, VLS-1488 has also demonstrated durable clinical benefit, with approximately half of patients with squamous non-small cell lung cancer remaining on therapy beyond six months.

To support its pipeline growth, Volastra has appointed Timothy Bowler, M.D., Ph.D., as Chief Medical Officer. He will oversee the expanded clinical program and drive the execution of the company’s development strategy. Dr. Bowler succeeds Dr. Scott Druttman, who is leaving Volastra to pursue other opportunities.

“Tim has been instrumental in driving our clinical progress, and we are delighted to have him step into the CMO role,” said Mr. Southwell. “His expertise in oncology drug development will be invaluable as we advance our pipeline and strive to deliver CIN-targeted therapies to patients.”

Dr. Bowler, a board-certified medical oncologist and experienced drug developer, previously served as Volastra’s Vice President of Clinical Development. Prior to joining Volastra in 2023, Dr. Bowler was Global Clinical Lead in oncology at Pfizer, and previously served at Regeneron and Memorial Sloan Kettering Cancer Center. In his new role, he will spearhead all clinical strategy and operations, guiding the KIF18Ai program through its next phase of growth and advancing Volastra’s broader clinical portfolio.

“Volastra’s innovative approach to targeting chromosomal instability has tremendous potential to benefit patients,” said Timothy Bowler, M.D., Ph.D., Chief Medical Officer of Volastra. “Our focus now is executing a disciplined development plan that builds on monotherapy activity while expanding the reach of KIF18Ai through combinations and biomarker-guided approaches.”

About Volastra Therapeutics, Inc.

Volastra Therapeutics is a New York-based clinical-stage biotechnology company pioneering novel approaches to treating cancer by targeting a tumor vulnerability known as chromosomal instability (CIN). The company was founded in 2019 by Lewis Cantley, Ph.D., Samuel Bakhoum, M.D., Ph.D., and Olivier Elemento, Ph.D., and is funded by Eli Lilly & Company, B Capital, ARCH Venture Partners, Polaris Partners, Droia Ventures, Vida Ventures, and Catalio Capital Management. Volastra is developing new techniques to understand the biology of chromosomal instability and leveraging these insights to drive a pipeline of therapies toward innovative targets. The company leads the field with two differentiated clinical-stage KIF18A inhibitors, VLS-1488 and sovilnesib (formerly AMG-650), along with a robust discovery pipeline.

For more information, please visit www.volastratx.com

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