Post Study II Monitoring of Response, Optional Maintenance Study II Treatments and Central Pathology Laboratory Review Optimized

TORONTO, ON / ACCESSWIRE / October 23, 2023 / Theralase® Technologies Inc. ("Theralase®" or the "Company") (TSXV:TLT)(OTCQB:TLTFF), a clinical stage pharmaceutical company dedicated to the research and development of light and/or radiation activated Photo Dynamic Compounds ("PDCs") for the safe and effective destruction of various cancers, bacteria and viruses, announced that it has been granted a Clinical Trial Application Amendment ("CTA-A") by Health Canada through receipt of a No Objection Letter ("NOL") for the optimization of the Phase II Non-Muscle Invasive Bladder Cancer ("NMIBC") clinical study ("Study II").

The Study II optimization consists of:

1. Post Study II Monitoring of Response - Patients, who achieved a Complete Response ("CR") or Indeterminate Response ("IR"), demonstrated a duration of that response at 450 days and remained in Study II will be monitored by the Company past 450 days, to help define the long-term duration of the Study II Treatment.
2. Optional Maintenance Study II Treatment -Patients currently receive a mandatory maintenance Study II Treatment at 180 days; however, this has been optimized to allow optional maintenance Study II Treatments, at the discretion of the Principal Investigator ("PI") based on the patient's response. For patients who have achieved a CR or IR at any point in time and have demonstrated a duration of that CR or IR, no further maintenance Study II Treatments would be administered; however, if the patient recurs at any scheduled assessment visit (i.e.: 90, 180, 270, 360 or 450 days), then that patient would be eligible to receive up to 2 maintenance Study II Treatments at the discretion of the PI to assist the patient in achieving a CR.
3. Central Pathology Laboratory Review - Use of a central pathology laboratory to validate local pathology laboratory results.

Note: CR is defined as:

• Negative cystoscopy and negative (including atypical) urine cytology
• Positive cystoscopy with biopsy-proven benign or low-grade NMIBC and negative cytology
• Negative cystoscopy with malignant urine cytology, if urothelial cancer is suspected in the upper tract or prostatic urethra and random bladder biopsies are negative

Note: IR is defined as:

• Negative cystoscopy and positive urine cytology, without confirmatory negative bladder cancer biopsies

Arkady Mandel, MD, PhD, DSc, Chief Scientific Officer of Theralase® stated, "Based on our latest published clinical results in Study II, we are quickly approaching a critical stage in our NMIBC clinical development and commercialization program. There remains an unmet need in providing an adequate treatment option for thousands of Bacillus Calmette-Guérin ("BCG")-Unresponsive NMIBC patients, who are facing radical cystectomy. With Health Canada's CTA-A NOL approval letter, we are a significant step closer to providing these patients around the world with a much-needed breakthrough therapy to help treat their deadly disease. The recent press release of the Study II interim clinical data analysis provides support that Ruvidar^TM based Anti-Cancer Therapy ("ACT") may present a safe and effective treatment option for this patient population. Theralase® looks forward to sharing additional safety and efficacy clinical data generated from Theralase®'s Study II next month."

Roger DuMoulin-White, BSc, P.Eng, Pro.Dir, President and Chief Executive Officer of Theralase® stated, "Theralase® is delighted in Health Canada's decision to grant the Company a CTA-A for Study II. These recent optimizations to Study II's clinical protocol allow Study II to be in better compliance for Canadian and US regulators, who will ultimately be responsible for reviewing and making the final decision on approving or denying the investigational treatment for human use. By working with Health Canada and the FDA to approve the optimization of the clinical study design, analysis and reporting structure of Study II early in the process, Theralase® is able to much better align the clinical data collected in Study II with best practices and current expectations of the Canadian and US regulators; thereby, helping to avoid difficult to address questions at final review time. Theralase® hopes that by introducing these optimizations in Study II, future reviews with the regulators will be more efficient. In addition, Theralase® is collecting the survival data for all patients, with central pathology laboratory validation, who have been previously enrolled and provided the primary Study II Treatment and who have demonstrated a CR or IR at any point in time, with duration of that CR or IR at 450 days, for submission to the FDA in support of a pre-Break Through Designation ("BTD") submission."

About Theralase® Technologies Inc.:

Theralase® is a clinical stage pharmaceutical company dedicated to the research and development of light and radiation activated compounds, their associated drug formulations and the light systems that activate them, with a primary objective of efficacy and a secondary objective of safety in the destruction of various cancers, 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 ("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 Photo Dynamic Compounds ("PDCs") 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 and the negative of such expressions; including, statements related to the completion of the Offering and the timing thereof, the use of proceeds of the Offering, the timely receipt of all necessary approvals, including any requisite approval of the TSXV, the current expectations of the Company's management for future research, development and commercialization of the Company's PDCs and their drug formulations; including: preclinical research, clinical studies, clinical development and regulatory approvals.

These statements involve significant risks, uncertainties and assumptions; including, whether the Company is able to: adequately fund and secure the requisite regulatory approvals to successfully complete preclinical and clinical studies in a timely fashion to implement its development plan; successfully commercialize its drug formulations; access sufficient capital to fund the Company's operations, which may not be available on terms that are commercially favorable to the Company or at all; provide preclinical and clinical support that the Company's drug formulations are effective against the conditions tested in its preclinical and clinical studies; comply with the term of license agreements with third parties, not to lose the right to use key intellectual property in its business; protect its intellectual property, the timing and success of this intellectual property and achieve 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 successfully come to fruition, and 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 statements.

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

Kristina Hachey, CPA
Chief Financial Officer
khachey@theralase.com
416.699.LASE (5273) x 224

SOURCE: Theralase Technologies Inc.