Theralase Bladder Cancer Clinical Data to be Presented at the 2026 European Association of Urology Congress

February 17, 2026 7:00 AM EST | Source: Theralase Technologies Inc.

Toronto, Ontario--(Newsfile Corp. - February 17, 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 2026 European Association of Urology Congress ("EAU26").

The EAU 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 presentation at EAU26 to be held in London, United Kingdom, from March 13th to 16th, 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. Girish Kulkarni in an oral 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 potential 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 have demonstrated a duration of response of 3 years or greater with a single treatment.

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

Girish Kulkarni, MD, PhD, FRCSC, a urologic surgeon in the Department of Surgical Oncology at the Princess Margaret Cancer Centre, University Health Network and Professor at the University of Toronto, Department of Surgery, stated, "We are excited that our clinical study has been accepted for presentation at the EAU26 Conference. The early data is supportive of light-activated Ruvidar®, as a treatment modality for BCG-Unresponsive NMIBC CIS, thus having the potential to allow patients to preserve their bladders and maintain their quality of life."

Arkady Mandel, MD, PhD, DSc, Chief Scientific Officer, Theralase® stated, "In the interim clinical data, we have observed a high efficacy and fovourable safety profile in bladder cancer patients treated at numerous clinical study sites across Canada and the US. The data supports the use of light-activated Ruvidar® in the treatment of patients with high-grade, high-risk NMIBC. In addition, the latest results demonstrate a long-lasting duration of complete response induced by this innovative technology, which is able to be completed within a few hours and is suitable for patients with CIS of the urinary bladder, who have not responded to previous therapies and who are currently facing a life-altering option, such as radical cystectomy."

Roger DuMoulin-White, BSc, P.Eng, Pro.Dir, President and Chief Executive Officer, Theralase®, stated, "The acceptance of the Theralase® abstract for presentation at the EAU26 Annual Conference is a testament to the importance and significant impact that this clinical research could have on the lives of bladder cancer patients. We look forward to the presentation and the continued development of Ruvidar® for bladder cancer patients. With patient enrollment completed, clinical data is expected to be submitted to Health Canada and the FDA in a rolling review commencing 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 EAU26:
EAU26 is Europe's largest urological event, with researchers and scientists from around the world presenting their latest research, which is critically examined and discussed by the field's leading experts. The EAU represents the leading authority within Europe on urological practice, research and education, with over 19,000 medical professionals.

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 (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/284094

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Source: Theralase Technologies Inc.

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