• Final patient dosed in Phase 1 study of SRG-514 in breast cancer patients undergoing breast-conserving surgery; registrational trial design being finalized with input from FDA
• Additional intraoperative immunotherapy programs in bladder and prostate cancer advancing toward Phase 2 trials in 2026

SURGE Therapeutics (SURGE), a clinical-stage oncology company pioneering intraoperative immunotherapy, today announced the final patient has been dosed in its Phase 1 clinical trial of SRG-514, an investigational therapy for breast cancer patients undergoing surgery. The treatment was generally well tolerated in the Phase 1 dose-escalation study, and there were no treatment-related dose-limiting toxicities or treatment-related serious adverse events to date. Based on the data generated to date and discussions with the FDA, the company is preparing to advance SRG-514 directly into a registrational trial.

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From left to right - Dr. Michael Goldberg (CEO, SURGE Therapeutics); Dr. Freya Schnabel (Director of Breast Surgery, NYU); Acacia Sharma (Research Project Manager, NYU); Shane Roberts (Field Clinical Manager, SURGE Therapeutics). Photo credit: SURGE Therapeutics

SRG-514 is designed to deliver immunotherapy intraoperatively, directly into the resection cavity during the time of tumor removal. The therapy aims to reprogram the local inflammatory response from immunosuppressive to immunostimulatory, with the goal of generating a durable, systemic anti-tumor immune response when tumor burden is at its lowest.

“Intraoperative immunotherapy represents a fundamentally different approach to treating cancer,” said Michael Goldberg, Ph.D., CEO & Founder, SURGE Therapeutics. “With SRG-514, we are targeting primary drivers of cancer mortality – post-surgical recurrence and metastasis – by improving how, when, and where immunotherapy is delivered. We are encouraged by the data generated to date and by the broader potential of our programs to serve as pipelines-in-a-product.”

“One of the most persistent challenges in oncology is that microscopic disease can remain even after successful tumor removal and later drive cancer recurrence, both locally and distally,” said Robert Langer, Sc.D., Institute Professor at MIT and Chair of SURGE’s Scientific Advisory Board. “Applying established principles of drug delivery in the intraoperative setting creates a powerful opportunity to influence immune responses where and when intervention may have the greatest impact.”

SRG-514 is a novel thermosensitive formulation of ketorolac, a non-steroidal anti-inflammatory drug commonly used perioperatively. By intervening during surgery, the therapy is designed to provide extended, localized release directly at the tumor resection site and may counteract surgery-induced immune suppression, a biological process that can promote recurrence and metastasis.

Post-surgical recurrence remains one of the most significant unmet needs in oncology, as 90% of cancer-related deaths are driven by local recurrence and metastasis. Each year, approximately 9 million cancer patients worldwide undergo surgical tumor resection, yet an estimated 40% of patients experience disease recurrence within five years. While surgery triggers acute inflammation, standard post-operative therapies are typically not administered until several weeks after surgery, allowing residual cancer cells time to develop strategies to evade immune surveillance.

SURGE’s proprietary SURGERx™ platform uses an injectable, biodegradable hydrogel optimized for intraoperative administration to deliver a drug in a highly concentrated manner.

The company expects to initiate a registrational trial of SRG-514 in triple-negative breast cancer this year, with potential expansion into additional breast cancer and solid tumor indications. In parallel, the company is advancing two additional intraoperative immunotherapy programs – STM-416 and STM-416p, utilizing the TLR7/8 agonist resiquimod, in bladder cancer and prostate cancer, respectively. Both programs are expected to enter Phase 2 clinical trials this year.

These programs highlight SURGE’s mission to transform surgery from a purely physical intervention into a therapeutic modality to deliver localized immunotherapy to potentially improve patient outcomes.

About SURGE Therapeutics

SURGE Therapeutics is a clinical-stage oncology company developing intraoperative immunotherapies designed to eliminate minimal residual disease at the time of cancer surgery. Through its proprietary SURGERx™ platform, the company delivers immunotherapy directly to the resection cavity with the intention of preventing post-surgical recurrence and drive durable antitumor immunity across solid tumors. For more information, visit www.surgetx.com.

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