June 24, 2024

Sustained Therapeutics Announces First Patient for Cancer Trial

The first patient has entered the Phase II/III trial of ST-02, Sustained Therapeutic’s innovative cancer medication targeting Upper Tract Urethral Carcinoma (UTUC).

A rare form of cancer, UTUC affects over 7,000 individuals annually across North America. UTUC is a cancer of the inside lining of the kidney (the “collecting system” – where urine starts to drain after it is made by the kidney) and the ureter (the tube that carries urine from the kidney to the bladder). Its location in the upper collecting system makes it challenging to access and completely remove with traditional laser resection.

“This is a major step forward in the treatment of UTUC,” says Dr. Peter Black, lead investigator of the clinical trial and a Senior Research Scientist with the Vancouver Prostate Centre. “Currently we have limited treatment options for this uncommon and challenging cancer, and this approach may allow better disease control without having to remove a kidney.”

The first patient in the clinical trial has been enrolled at the Vancouver Prostate Centre, and it is anticipated that 5 other sites will take part in the study. The company plans on enrolling approximately 75 patients in the combined Phase II/III trial and believes that ST-02 may be designated an orphan drug. Orphan drug designation can qualify the company for incentives such as tax credits, exemption from user fees, and seven years of market exclusivity after approval.

Sustained Therapeutics’ ST-02 product for UTUC is a sustained release formulation that enables direct delivery of chemotherapy to the site of the carcinoma via a catheter. Using the company’s proprietary platform technology, the medication releases slowly over about 24 hours exactly where the cancer is located, coating the tissue and delivering chemotherapy at higher concentrations and for longer than the current standard of care. The company believes that this direct sustained delivery may be more effective and result in fewer side effects than other forms of chemotherapy that are a current standard of care.

“ST-02 is Sustained Therapeutic’s second product to reach Phase II trials, and demonstrates our potential to develop multiple products using our novel drug delivery platforms. As such, it is a very important development in our portfolio,” says Dr. Martin Gleave, Founder and Chief Medical Office of Sustained Therapeutics and Distinguished Professor in the UBC Department of Urologic Sciences and Director of the Vancouver Prostate Centre (VPC). “This new therapeutic, designed specifically for UTUC, could address and important unmet need for patients. It’s an exciting time to be a part of this work.”

About Sustained Therapeutics:

Sustained Therapeutics is a clinical-stage company utilizing its advanced clinical and research expertise to develop locally injected sustained-release therapeutics for the treatment of a broad range of conditions, including cancer, inflammatory diseases and pain. A spin-off from the University of British Columbia its novel sustained-release drug delivery platform is also the basis for ST-01, the Company’s medication for managing both acute and chronic pain. Sustained Therapeutics has completed a successful Phase I trial of ST-01 and currently has two Phase II trials underway, one in acute post-operative pain and the other in chronic pain.

Contact:

William Annett, Chief Executive Officer

wannett@sustainedtherapeutics.com

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 planned initial and expanded Phase II/III trials, beliefs that the delivery mechanism of our new product may provide benefits over current standard of care treatment for UTUC, and the potential benefits of ST-02 and the Company’s platform technology including the significant potential to treat a rare form of cancer and the potential success of demonstrating that our platform technology can be used for multiple different extended-release products. 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 “may”, “will”, “potential”, “believes” and “if” 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.

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