Convergent Therapeutics Inc., a clinical-stage biotechnology company developing next-generation radiopharmaceuticals for the treatment of cancer, today announced compelling results from Part 2 of the Phase 2 CONVERGE-01 study evaluating Ac-225 rosopatamab tetraxetan (CONV01-α) in patients with Lu-PSMA-naïve, androgen pathway modulator-resistant (APMR) prostate cancer. In the study, CONV01-α demonstrated potent anti-tumor activity, including deep prostate specific antigen (PSA) responses following a two-dose regimen, with a favorable safety profile.

In the study, CONV01-α achieved a PSA50 response rate of 84% and a PSA90 response rate of 26% demonstrating substantial anti-tumor activity in patients with rapidly progressing disease. Treatment was well tolerated, with clinically manageable hematologic toxicity at the target dose and no renal or hepatic toxicity or high-grade xerostomia observed. Direct Actinium-225 dosimetry also demonstrated the feasibility of measuring radiation exposure in normal organs, with reassuring absorbed-dose estimates that provide additional support for the favorable safety and tolerability profile observed to date.

“The depth of PSA responses observed with only two doses of Ac-225 rosopatamab tetraxetan, together with its favorable safety profile, offers a particularly compelling option for patients with metastatic castration-resistant prostate cancer (or APMR) who have not yet received Lu-PSMA, a population for whom novel treatment options are needed,” said Praful Ravi, MB, BChir, MRCP, Medical Director of Genitourinary Theranostics at Dana-Farber Cancer Institute. “The patient-friendly two-dose regimen also has the potential to substantially reduce treatment burden, allowing patients to resume their usual activities and family lives at home without prolonged radiation-related isolation.”

The study findings build on previously reported Phase 2 results in patients treated with Lu-PSMA therapy and reinforce the potential of CONV01-α as a differentiated treatment option across multiple stages of advanced prostate cancer.

“These results reinforce our conviction that CONV01-α has the potential to become an important treatment option across the prostate cancer therapy continuum,” said Philip Kantoff, M.D., Co-Founder and Chief Executive Officer of Convergent Therapeutics. “Demonstrating substantial anti-tumor activity in patients both before and after Lu-PSMA treatment underscores the significant opportunity for targeted alpha therapies in a disease where curative options remain limited. We look forward to continuing CONVERGE-01, further exploring its potential in this earlier treatment setting and advancing our development plans to bring this promising therapy to patients.”

ESMO program details:

Abstract Title: CONVERGE-01: Ac-225 Rosopatamab Tetraxetan (CONV01-α) in Patients with Androgen Pathway Modulator Resistant Prostate Cancer (APMR)

Abstract Number: 2266P

Format: Poster Presentation

Location: IFEMA, Madrid

Date and Time: October 23, 2026, 3:15 pm CEST

Presenter: Praful Ravi, MB, BChir, MRCP, Medical Director of Genitourinary Theranostics at Dana-Farber Cancer Institute

About CONV01-α

CONV01-α is a PSMA-targeted Ac-225 radioantibody that pairs antibody precision with the localized potency of alpha radiation. CONV01-α, which is being developed to improve the treatment of mCRPC, uses a humanized monoclonal antibody (rosopatamab) directed against PSMA, a well-established and highly expressed antigen in prostate cancer. CONV01-α is differentiated by its ability to precisely deliver actinium-225 (Ac-225) through this PSMA-targeting antibody, enabling precise short-range, high-energy alpha particle radiation that creates focused DNA damage within tumor cells while limiting exposure to surrounding tissues. Initial studies in more than 120 patients have established clinical proof-of-concept for CONV01-α, showing consistent antitumor activity and a differentiated safety profile. This selectivity, combined with strong tumor retention and minimal salivary and renal uptake, supports the potential of CONV01-α to be a clinically impactful therapy for PSMA-positive cancers.

About Convergent Therapeutics, Inc.

Convergent Therapeutics, Inc. is a clinical-stage biotechnology company developing next-generation radiopharmaceuticals to transform the treatment of cancer. Founded by world-renowned experts in clinical oncology, drug development, and cancer biology, Convergent is advancing a pipeline of tumor-selective radioantibodies that pair the precision of antibody targeting with the localized, cell-destructive potency and extended half-life of Actinium-225 (Ac-225) alpha-emitting isotopes. The company’s lead program, CONV01-α, is a PSMA-targeted Ac-225 radioantibody in development for metastatic castration-resistant prostate cancer (mCRPC). CONV01-α has demonstrated clinical proof of concept and in Phase 2 studies, consistent antitumor activity, durability and a differentiated safety and tolerability profile, both as monotherapy and in combination with other anti-cancer agents. Convergent has also established a reliable, domestically sourced Ac-225 supply chain to support late-stage and clinical development programs. More information can be found at www.convergentrx.com.

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