Interim clinical data has exceeded the recommended guidelines of the International Bladder Cancer Group for complete response and duration of complete response
Toronto, Ontario--(Newsfile Corp. - February 4, 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 provide an update on the Phase II clinical study for bladder cancer.
To date, 90 patients have been enrolled and treated with the Theralase® Study Procedure, achieving the patient enrollment specified by the statistical analysis plan.
78 patients have completed the clinical study and were evaluated at all scheduled assessment visits or were prematurely removed by the principal investigator due to lack of response. There are 12 patients pending study completion.
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).
Note: Theralase® believes all Serious Adverse Events ("SAEs") reported to date are unrelated or unlikely related to the Study Drug or Study Device.
These results exceed the International Bladder Cancer Group's recommended guidelines of "clinically meaningful initial complete response rates for carcinoma in situ of at least 50% at 6 months and 30% at 12 months."1
Interim data from 47 patients indicates that complete response rates of 21.3% at both 2 and 3 years and 2.1% at 7 years were sustained.
Theralase® will compile the clinical data in 2026 for presentation to Health Canada and FDA with an expected regulatory approval in 2027.
About Phase II Clinical Study:Primary Endpoint: Efficacy (complete response at any point in time)
Secondary Endpoint: Efficacy (duration of complete response of 12 months)
Tertiary Endpoint: Safety (serious adverse events directly related to the study drug or study device that do not resolve within 450 days)
Study Procedure: Light-activated Ruvidar®
Patient Population: Bacillus Calmette-Guérin ("BCG")-Unresponsive Non-Muscle Invasive Bladder Cancer ("NMIBC") Carcinoma In-Situ ("CIS"), who have failed standard-of-care therapy and are facing radical cystectomy (bladder removal) ("Study II").
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 men,4 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:
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/282520
To date, 90 patients have been enrolled and treated with the Theralase® Study Procedure, achieving the patient enrollment specified by the statistical analysis plan.
78 patients have completed the clinical study and were evaluated at all scheduled assessment visits or were prematurely removed by the principal investigator due to lack of response. There are 12 patients pending study completion.
| Primary Endpoint Performance (CR at any Point in Time) | |||
| # | % | Confidence Interval (95%) | |
| Complete Response ("CR") | 56/87 | 64.4% | [48.6, 80.2] |
| Total Response (CR and IR) | 64/87 | 73.6% | [56.7, 90.5] |
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).
| Secondary Endpoint Performance (Duration of CR) (450 Days) | |||
| # | % | Confidence Interval (95%) | |
| Complete Response | 19/47 | 40.4% | [23.8, 57.1] |
| Total Response | 20/47 | 42.6% | [26.6, 58.5] |
| Tertiary Endpoint Performance (Safety) (450 Days) | ||
| # | % | |
| Safety | 78/78 | 100.0% |
Note: Theralase® believes all Serious Adverse Events ("SAEs") reported to date are unrelated or unlikely related to the Study Drug or Study Device.
These results exceed the International Bladder Cancer Group's recommended guidelines of "clinically meaningful initial complete response rates for carcinoma in situ of at least 50% at 6 months and 30% at 12 months."1
Interim data from 47 patients indicates that complete response rates of 21.3% at both 2 and 3 years and 2.1% at 7 years were sustained.
Theralase® will compile the clinical data in 2026 for presentation to Health Canada and FDA with an expected regulatory approval in 2027.
About Phase II Clinical Study:Primary Endpoint: Efficacy (complete response at any point in time)
Secondary Endpoint: Efficacy (duration of complete response of 12 months)
Tertiary Endpoint: Safety (serious adverse events directly related to the study drug or study device that do not resolve within 450 days)
Study Procedure: Light-activated Ruvidar®
Patient Population: Bacillus Calmette-Guérin ("BCG")-Unresponsive Non-Muscle Invasive Bladder Cancer ("NMIBC") Carcinoma In-Situ ("CIS"), who have failed standard-of-care therapy and are facing radical cystectomy (bladder removal) ("Study II").
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 men,4 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:
- Rose KM et al., Systematic Review and Meta-Analysis of Response Rates in BCG-unresponsive Non-Muscle-Invasive Bladder Cancer: A Consensus Statement From the International Bladder Cancer Group. Société Internationale d'Urologie Journal. 2022; 3(5):333-339.
- Urology Care Foundation. Non-muscle Invasive Bladder Cancer. https://www.urologyhealth.org/urology-a-z/n/non-muscle-invasive-bladder-cancer. Accessed November 2025.
- National Cancer Institute. Cancer Statistics. https://www.cancer.gov/about-cancer/understanding/statistics. Accessed November 2025.
- 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.
- 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.
- 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.
- National Comprehensive Cancer Network. Bladder Cancer (Version 2.2025). https://www.nccn.org/professionals/physician_gls/pdf/bladder.pdf. Accessed November 2025.
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/282520