Sustained Therapeutics Presents Positive Phase 2 Data for ST-01 in Podium Presentation at the American Urological Association 2026 Annual Meeting

ST-01 demonstrated statistically significant and durable pain reduction in men with chronic scrotal content pain at the 70 mg/ml dose compared to standard of care

VANCOUVER, British Columbia--(BUSINESS WIRE)--Sustained Therapeutics, Inc. (“Sustained Therapeutics” or the “Company”), a clinical-stage urologic therapeutics company advancing differentiated therapies for underserved conditions, today presented additional data from its Phase 2 study evaluating ST-01, a proprietary non-opioid sustained-release small molecule therapy, in men with chronic scrotal content pain (CSCP).

The data were presented in an oral podium presentation at the American Urological Association (AUA) 2026 Annual Meeting in Washington, DC today by lead investigator, Ryan K Flannigan, MD, Associate Professor, Department of Urologic Sciences, University of British Columbia and Director of the Male Reproductive and Sexual Medicine Research Program and Fellowship Director for Male Reproductive Medicine, Sexual Medicine & Microsurgery. In the randomized Phase 2 study, ST-01 demonstrated statistically significant improvements in pain reduction and clinical response rates at the 70 mg/mL dose compared to standard of care alone. The treatment was generally well tolerated, and responses were shown to be durable over repeated dosing cycles.

“Chronic scrotal content pain remains a challenging and underrecognized condition in urology with many patients cycling through therapies that provide only temporary relief,” said Dr. Flannigan. He continued, “The safety and efficacy signals observed in this study are highly encouraging and support continued evaluation of ST-01 as a potential new therapeutic option for these patients. Our hope is that this work may ultimately lead to a transformative, non-surgical treatment approach for men living with chronic scrotal pain, pending additional studies to validate these findings.”

The data were presented during Podium Session PD26: Sexual Function/Dysfunction – Medical, Hormonal & Non-surgical Therapy II at AUA 2026 (Abstract PD26-15), titled “A Randomized Phase 2 Study of Repeat Dose ST-01 (Lidocaine Polymer Solution) vs Lidocaine for Spermatic Cord Block in Men with Chronic Scrotal Content Pain.”

“These results reinforce the growing excitement within the urology community around the potential for a non-opioid treatment option for chronic urologic pain,” said William Annett, Chief Executive Officer of Sustained Therapeutics. “We believe ST-01 has the potential to transform care for patients while also delivering meaningful value for physicians and their patients as well as seeking alternatives to repeated procedures, chronic opioid use, and invasive surgery.”

Key Phase 2 Study Results

The randomized, multi-center, single-blind, active-controlled Phase 2 study enrolled 63 men across eight clinical sites in Canada evaluating repeat monthly dosing of ST-01 in CSCP. The study compared ST-01 to standard-of-care spermatic cord block with lidocaine alone (control).

At the 70 mg/mL dose, ST-01 demonstrated statistically significant improvements in both the primary and secondary efficacy endpoints compared to control.

Key findings included:

• 67% of patients treated with ST-01 70 mg/mL achieved a treatment response, defined as a ≥2-point reduction in pain scores, compared to 26% in the control arm (p=0.01)
• 83% of patients receiving ST-01 70 mg/mL achieved a clinical response based on cycle-average pain scores, compared to 32% in the control arm (p=0.001)
• Patients who crossed over from control treatment to ST-01 achieved >80% response further supporting the therapeutic effect of ST-01

The Company believes these findings support continued development of ST-01 as a potential non-opioid treatment option for CSCP and plans to advance the program toward Phase 3 development, subject to regulatory review.

Chronic scrotal content pain is a debilitating condition affecting an estimated 5 million men in North America with approximately 700,000 new cases diagnosed annually. Current treatment options are limited and often inconsistent, ranging from oral analgesics and opioids to invasive surgical procedures. Sustained Therapeutics believes ST-01 has the potential to address a significant unmet need as a targeted, non-opioid therapy designed to provide durable localized pain relief.

Beyond chronic scrotal content pain, the Company believes its sustained-release platform may have broader applicability across additional chronic pain indications, including chronic pelvic pain, a condition affecting an estimated 13 million men and women in North America with few effective long-term treatment options. Sustained Therapeutics plans to evaluate ST-01 in chronic pelvic pain in future clinical studies.

According to market research conducted by the Company, approximately 80% of urologists surveyed identified chronic urologic pain as a significant unmet need in clinical practice. Sustained Therapeutics believes ST-01’s targeted, office-based administration and non-opioid profile may provide meaningful benefits across the healthcare ecosystem including improved quality of life for patients, an easy-to-administer therapeutic option for physicians, and the potential to reduce downstream healthcare costs associated with repeat procedures, opioid utilization, and surgery.

About Sustained Therapeutics:

Sustained Therapeutics is a clinical-stage urology company developing differentiated therapeutics for underserved urologic conditions. Founded by leading urologists and scientists from the University of British Columbia and the Vancouver Prostate Centre, the Company is advancing a pipeline of urology products designed to provide durable, localized treatment while minimizing systemic exposure.

The Company’s lead program, ST-01, is an investigational therapy for chronic urologic pain, including chronic scrotal content pain and chronic pelvic pain. Sustained Therapeutics’ proprietary, patent-protected drug delivery platform is also being developed across additional urologic indications, including oncology, erectile dysfunction, female sexual dysfunction, and fibrotic diseases.

Sustained Therapeutics is focused on transforming care in urology through targeted therapies that address significant unmet clinical needs while improving outcomes for patients, physicians, and healthcare systems.

For more information, visit www.sustainedtherapeutics.com or follow us on LinkedIn.

Notice Regarding Forward-Looking Statements:

This news release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and forward-looking information within the meaning of applicable Canadian securities laws (collectively, "forward-looking statements"), including statements regarding the results of the Phase 2 trial and the potential benefits of the Company’s therapeutics. Statements in this document regarding future expectations, beliefs, or plans constitute forward-looking statements that involve risks and uncertainties, which may cause actual results to differ materially from the statements made. Without limiting the foregoing, the words "seeks", "believes", "plans", and "indicates" are intended to identify forward-looking statements. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause actual results, future circumstances, or events to differ materially from those projected in the forward-looking statements. These risks include but are not limited to those associated with the success of research and development programs; the ability to raise additional funding; and the need to obtain regulatory approval. Forward-looking statements are developed based on assumptions about such risks, uncertainties and other factors, including, but not limited to research and development plans proceeding substantially as envisioned, safety of product, and availability of financing on reasonable terms. Forward-looking statements are made as of the date hereof, and the Company disclaims any intention and has no obligation or responsibility, except as required by law, to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.