Theralase(R) Bladder Cancer Clinical Data to be Presented at the 2026 American Urological Association Annual Meeting

Rhea-AI Summary

Theralase (OTCQB: TLTFF) announced interim Phase II clinical data for light-activated Ruvidar (TLD-1433) in BCG-unresponsive non-muscle invasive bladder cancer carcinoma in-situ (NMIBC CIS), accepted for interactive poster presentation at the 2026 AUA Annual Meeting (May 15-18, 2026).

The interim dataset highlights 78 patients who completed enrollment, with select responses: 2/3 complete responses in a subset, 2/5 maintaining response ≥15 months, and 1/5 showing ≥3-year duration after a single treatment. Rolling regulatory submissions to Health Canada and the FDA are expected to begin in 3Q2026, with approvals targeted in 2027.

Positive

• Interim dataset includes 78 patients who completed Study II
• Select patients showed strong durability: 1 patient ≥3 years response after one treatment
• 2 of 3 patients obtained a complete response in a reported subset
• Company plans rolling submissions to Health Canada and FDA starting 3Q2026

Negative

• Key efficacy claims based on small reported subsets (e.g., 3 and 5 patients)
• Regulatory approval remains pending, targeted in 2027 and not guaranteed
• Commercial availability contingent on successful review and approvals before market access

Toronto, Ontario--(Newsfile Corp. - February 10, 2026) - Theralase® Technologies Inc. (TSXV: TLT) (OTCQB: TLTFF) ("Theralase®" or the "Company"), a clinical stage pharmaceutical company dedicated to the research and development of energy-activated small molecules for the safe and effective destruction of cancer, bacteria and viruses, is pleased to announce that its interim clinical data has been selected for presentation at the American Urological Association ("AUA") Annual Meeting.

The program committee of the AUA has accepted Theralase®'s abstract titled, "Interim Analysis of Light-Activated TLD-1433 in a Phase II Clinical Study of BCG-Unresponsive Non-Muscle Invasive Bladder Cancer Carcinoma In-Situ" for an interactive poster presentation at the 2026 AUA Annual Meeting to be held in Washington, DC, from May 15^th to 18^th, 2026.

The interim clinical data from Theralase®'s international, multicenter Phase II Bacillus Calmette-Guérin ("BCG")-Unresponsive Non-Muscle Invasive Bladder Cancer ("NMIBC") Carcinoma In-Situ ("CIS") study ("Study II") will be presented by principal investigator Dr. Wassim Kassouf in an interactive poster presentation.

Enrollment has been completed in Study II and Theralase® expects to commence submission of the clinical data in a rolling review to Health Canada and the FDA in 3Q2026. Pending regulatory approval, expected in 2027, this innovative technology represents an opportunity for a significant advancement in bladder cancer therapy, providing a safe and effective treatment for patients, who have exhausted their standard of care therapeutic options and are facing radical cystectomy (bladder removal).

The interim clinical data supports the safety and efficacy of the treatment with 2 out of 3 patients obtaining a complete response and 2 out of 5 patients maintaining that complete response for 15 months or more. In post study analysis, 1 out of 5 patients demonstrated a duration of response of 3 years or greater with a single treatment.

These interim findings are encouraging in support of the use of light-activated Ruvidar® by the international urology community to safely and effectively treat patients inflicted with BCG-Unresponsive NMIBC CIS, helping to revolutionize the treatment landscape for bladder cancer.

Wassim Kassouf, MD, PhD, FRCSC, a urologic surgeon in the Department of Surgery, Division of Adult Urology at McGill University Health Centre, Stephen Jarislowsky Chair in Urology and Professor, Department of Surgery, Faculty of Medicine and Health Sciences, McGill University stated, "My colleagues and I are pleased that our clinical research has been accepted in an interactive poster presentation at the AUA Annual Meeting. The interim clinical data of 78 patients, who have completed the study, demonstrates meaningful safety and efficacy in the use of light-activated Ruvidar®, as a treatment for BCG-Unresponsive NMIBC CIS, thus helping patients to preserve their bladders and maintain their quality of life."

Arkady Mandel, MD, PhD, DSc, Chief Scientific Officer, Theralase® stated, "Light-activated Ruvidar® has delivered a high efficacy, significant duration of response and favourable safety profile in BCG-Unresponsive NMIBC CIS patients treated in Canada and the US. The interim clinical data supports the use of light-activated Ruvidar® in the treatment of patients with high-grade, high-risk NMIBC. The treatment is completed within a few hours and is suitable for patients, who have not responded to previous therapies and who are currently facing a life-altering option, such as a radical cystectomy."

Roger DuMoulin-White, BSc, P.Eng, Pro.Dir, Chief Executive Officer, Theralase® stated, "The acceptance of the Theralase® abstract for interactive poster presentation at the AUA Annual Meeting provides an opportunity for Theralase® to showcase the Study II clinical data to an international clinical audience. Patient enrollment has been completed, with clinical data submission planned in a rolling review to Health Canada and the FDA, commencing in 3Q2026. Pending successful regulatory approval, expected in 2027, Theralase® plans to make this technology commercially available to the entire urological community, commencing with Canada and the United States."

About the AUA:
The AUA Annual Meeting is one of the world's largest gatherings of urological professionals, bringing together leading researchers, clinicians and industry experts to share the latest advancements in urological care and research. The AUA is a premier urologic association that has been supporting the specialty of urology for over a century and is dedicated to promoting the highest standards of urological clinical care through education, research and the formulation of health care policy.

About Study II:
Study II utilizes the therapeutic dose of the patented drug, Ruvidar® (TLD-1433) activated by the patented study device, the TLC-3200 Medical Laser System. Study II has enrolled and treated 90 BCG-Unresponsive NMIBC CIS patients in 12 clinical study sites located in Canada and the United States.

About NMIBC:
NMIBC is a form of bladder cancer that is found in the inner layer cells of the bladder and does not invade into or beyond the muscle wall.² In the United States, bladder cancer is the sixth most common cancer,³ fourth among men⁴ and it is estimated that there will be approximately 84,870 new cases of bladder cancer in the U.S. in 2025.⁴ Historically, 75% of bladder cancer presents as NMIBC.⁵ In patients with high-risk NMIBC, intravesical BCG remains the first-line standard-of-care; however, approximately one third of patients with NMIBC will not respond to BCG therapy and 50% of those with an initial response will experience recurrence or progression of their disease.⁶ Current treatment options for BCG-unresponsive patients are very limited and National Comprehensive Cancer Network guidelines recommend cystectomy (partial or complete removal of the bladder).⁷

About Ruvidar®:
Ruvidar® is a small molecule activated by energy, intended for the safe and effective destruction of cancer, bacteria and viruses.

About Theralase® Technologies Inc.:
Theralase® is a clinical stage pharmaceutical company dedicated to the research and development of energy-activated small molecules for the safe and effective destruction of cancer, bacteria and viruses.

Additional information is available at www.theralase.com and www.sedarplus.ca.

References:

1. Kamat AM et al. Definitions, End Points, and Clinical Trial Designs for Non-Muscle-Invasive Bladder Cancer: Recommendations From the International Bladder Cancer Group. J Clin Oncol. 2016 Jun 1;34(16):1935-44.
2. Urology Care Foundation. Non-muscle Invasive Bladder Cancer. https://www.urologyhealth.org/urology-a-z/n/non-muscle-invasive-bladder-cancer. Accessed November 2025.
3. National Cancer Institute. Cancer Statistics. https://www.cancer.gov/about-cancer/understanding/statistics. Accessed November 2025.
4. American Cancer Society. Cancer Facts & Figures 2025. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2025/2025-cancer-facts-and-figures-acs.pdf. Accessed November 2025.
5. Babjuk M, Burger M, Capoun O, et al. European Association of Urology Guidelines on Non-muscle-invasive Bladder Cancer. Eur Urol. 2022 Jan;81(1):75-94.
6. Lidagoster S, et al. BCG and Alternative Therapies to BCG Therapy for Non-Muscle-Invasive Bladder Cancer. Curr Oncol. 2024 Feb 16;31(2):1063-1078.
7. National Comprehensive Cancer Network. Bladder Cancer (Version 2.2025). https://www.nccn.org/professionals/physician_gls/pdf/bladder.pdf. Accessed November 2025.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Forward-Looking Statements

This news release contains Forward-Looking Statements ("FLS") within the meaning of applicable Canadian securities laws. Such statements include; but, are not limited to statements regarding the Company's proposed development plans with respect to small molecules and their drug formulations. FLS may be identified by the use of the words "may, "should", "will", "anticipates", "believes", "plans", "expects", "estimate", "potential for" and similar expressions; including, statements related to the current expectations of the Company's management regarding future research, development and commercialization of the Company's small molecules; their drug formulations; preclinical research; clinical studies and regulatory approvals.

These statements involve significant risks, uncertainties and assumptions; including, the ability of the Company to fund and secure regulatory approvals to successfully complete various clinical studies in a timely fashion and implement its development plans. Other risks include: the ability of the Company to successfully commercialize its small molecule and drug formulations; access to sufficient capital to fund the Company's operations is available on terms that are commercially favorable to the Company or at all; the Company's small molecule and formulations may not be effective against the diseases tested in its clinical studies; the Company fails to comply with the terms of license agreements with third parties and as a result loses the right to use key intellectual property in its business; the Company's ability to protect its intellectual property; the timing and success of submission and acceptance and approval of regulatory filings. Many of these factors that will determine actual results are beyond the Company's ability to control or predict.

Readers should not unduly rely on these FLS, which are not a guarantee of future performance. There can be no assurance that FLS will prove to be accurate as such FLS involve known and unknown risks, uncertainties and other factors, which may cause actual results or future events to differ materially from the FLS.

Although the FLS contained in the press release are based upon what management currently believes to be reasonable assumptions, the Company cannot assure prospective investors that actual results, performance or achievements will be consistent with these FLS.

All FLS are made as of the date hereof and are subject to change. Except as required by law, the Company assumes no obligation to update such FLS.

For investor information on the Company, please feel to reach out Investor Inquiries - Theralase Technologies.

For More Information:
1.866.THE.LASE (843.5273)
416.699.LASE (5273)
www.theralase.com

Kristina Hachey, CPA
Chief Financial Officer X 224
khachey@theralase.com

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/283299

FAQ

What interim Phase II results did Theralase (TLTFF) present for Ruvidar at AUA 2026?

The interim analysis showed encouraging responses in selected patients, including durable complete responses. According to the company, 78 patients completed enrollment, with reported subset outcomes: 2/3 complete responses, 2/5 maintaining ≥15 months, and 1/5 with ≥3-year response.

When will Theralase (TLTFF) submit Study II clinical data to regulators?

Theralase plans to begin rolling submissions in the third quarter of 2026. According to the company, data submission to Health Canada and the FDA will commence in 3Q2026, with potential approvals expected in 2027 if reviews are successful.

How many patients completed Theralase's Phase II BCG-unresponsive NMIBC CIS study (TLTFF)?

Seventy-eight patients completed enrollment in Study II, per company disclosure. According to the company, the international, multicenter study enrolled and completed 78 patients who form the basis of the interim clinical dataset.

What is the clinical significance of Ruvidar (TLD-1433) results for bladder preservation (TLTFF)?

The interim data suggest potential bladder-preserving benefit for some patients who exhausted standard care. According to the company, outcomes include complete responses and multi-month to multi-year durability, indicating a possible alternative to radical cystectomy if approved.

How might Theralase's (TLTFF) AUA presentation affect regulatory and commercialization timelines?

The AUA presentation advances clinical visibility but does not change approval timelines directly. According to the company, clinical data submission begins 3Q2026 with regulatory approval expected in 2027, and commercialization awaits successful regulatory review.