Toronto, Ontario--(Newsfile Corp. - October 26, 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 various cancers, bacteria and viruses, is providing an update on its Phase II Bacillus Calmette-Guérin ("BCG")-Unresponsive Non-Muscle Invasive Bladder Cancer ("NMIBC") Carcinoma In-Situ ("CIS") clinical study (with or without resected Ta/T1 papillary disease) ("Study II") and in addition its expanding oncology pipeline.

Study II Interim Clinical Data

Study II has enrolled 96 patients (statistical analysis plan calculated a population size of 90 patients). 87 patients have completed Study II and 9 remain on study, pending secondary endpoint assessment.

81% of patients were ≥ 65 years, 82% male, 83% white, 82% diagnosed with pure CIS, 12% with CIS + T1; and 6% with CIS + Ta, 98% were BCG-Unresponsive and 2% BCG-Intolerant. The median number of BCG installations was 15.4.

93 patients have been assessed for the primary endpoint, 54 for the secondary endpoint and 87 for the tertiary endpoint.

Table 1: Primary Endpoint Performance

Approximately 2 out of 3 patients in Study II achieved a CR following the Theralase® procedure. Approximately 3 out of 4 patients achieved a Total Response.

Note: Indeterminate Response ("IR") is defined as negative cystoscopy (no evidence of Urothelial Cell Carcinoma ("UCC") in the bladder) and positive / suspicious urine cytology (detection of cancer in the urine, without a negative confirmatory bladder biopsy, suggesting UCC in the renal system other than the bladder).

Table 2: Secondary Endpoint Performance

Approximately 2 out of 5 patients who responded to the Theralase® procedure maintained their CR for 15 months. The median duration of response was 14.9 months [95% CI: 12.1, 17.7].

Table 3: Tertiary Endpoint Performance

Treatment Emergent Adverse Events ("TEAEs") were noted, but did not meet the Serious Adverse Event ("SAE") criteria. TEAEs included hematuria (47.9%), urinary frequency (39.5%) and urinary urgency (32.3%), which had a median resolution of 15, 36 and 43 days, respectively.

25 (26.9%) Serious Adverse Events have been documented: 1 x Grade I, 3 x Grade II, 14 x Grade III, 4 x Grade IV (all resolved between 1 to 82 days) and 3 x Grade V. 92% were not TEAEs.

Patients who completed the study were followed for up to 3 years after the initial procedure to further analyze duration of response. Approximately 1 out of 5 patients in Study II demonstrated a duration of response at 2 years and 3 years post the Theralase® procedure. One patient demonstrated a CR for 7 years, after one Theralase® procedure.

Table 4: Duration of CR at Extended Time Points

The interim results support light-activated Ruvidar® as a viable treatment option for patients with BCG-Unresponsive NMIBC CIS (+/- papillary disease) with an acceptable safety profile.

Regulatory and Commercialization Strategy
Enrollment into Study II has been completed with complete clinical data collected on 87 patients. Theralase® is currently analyzing and compiling the clinical data for submission of a New Drug Submission ("NDS") to Health Canada and a New Drug Application ("NDA") to the United States Food and Drug Administration ("FDA") with marketing decisions anticipated in 2027.

In 2027, Theralase® will pursue licensing agreements of the bladder cancer technology for global marketing and distribution of light-activated Ruvidar®.

Oncology Pipeline Expansion
Theralase^® is working with a Good Laboratory Practices ("GLP") laboratory, in the completion of GLP toxicology studies for Rutherrin^®, to determine the Maximum Tolerated Dose ("MTD") and corresponding Human Equivalent Dose ("HED") for additional oncological conditions. This work is expected to be completed in 1Q2027. In 2027, subject to regulatory approval, the Company intends to commence clinical development through Phase 0/I/II adaptive clinical studies for: Glioblastoma Multiforme ("GBM"), Non-Small Cell Lung Cancer ("NSCLC") and Muscle Invasive Bladder Cancer ("MIBC").

Topical Ruvidar^® GLP Toxicology and Pipeline Expansion
In 2027, Theralase^® plans to commence GLP toxicology studies for topical Ruvidar^® to determine the MTD and corresponding HED for the treatment of Herpes Simplex Virus-1 ("HSV-1") derived cold sores. In 2027, subject to regulatory approval, the Company intends to commence Phase I/II/III adaptive clinical studies for HSV-1 derived cold sores.

About Study II
Study II utilizes the therapeutic dose of the patented drug, Ruvidar^® (TLD-1433), activated by the TLC-3200 Medical Laser System. Study II has enrolled and treated 96 BCG-Unresponsive NMIBC CIS (with or without resected Ta/T1) patients across 11 clinical study sites located in Canada and the United States.

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.

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 and forward-looking information (collectively, "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 energy-activated 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 to the Company include: successful commercialization of its energy-activated small molecules and drug formulations; access to sufficient capital to fund the Company's operations on terms that are commercially favorable to the Company or at all; the safety and effectiveness of the Company's energy-activated small molecules and formulations against the diseases tested in its clinical studies; the failure to comply with the terms of license agreements with third parties and as a result lose the right to use key intellectual property in its business; the ability to protect its intellectual property; the timing and success of submission, 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.

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