Theralase Technologies Inc. reports company developments as a clinical-stage pharmaceutical developer of energy-activated small molecules for the destruction of cancer, bacteria and viruses. Its updates center on Ruvidar® (TLD-1433), including clinical and regulatory disclosures tied to non-muscle invasive bladder cancer and research into antiviral mechanisms such as HSV-1 inactivation.
Recurring announcements also cover operating and financial results, non-brokered private placements, line-of-credit financing, capital-structure disclosure, governance matters and development collaborations. The company’s news commonly links research progress with funding needs, regulatory pathways, intellectual-property considerations and commercialization risks for its small-molecule drug formulations.
Theralase Technologies (TSXV:TLT)(OTCQB:TLTFF) announced breakthrough research from the University of Manitoba demonstrating that non-light activated Ruvidar™ is more effective than acyclovir in treating Herpes Simplex Virus (HSV) post-infection. The research, conducted by Dr. Kevin Coombs, showed that Ruvidar™ inhibited HSV-1 replication at significantly lower concentrations compared to acyclovir, the current gold standard treatment.
The study revealed both additive and synergistic anti-HSV-1 effects when combination therapy was tested. Light-activated Ruvidar™ has previously shown even greater effectiveness in HSV inactivation. With over 90% of the human population infected with HSV, Theralase plans to develop both a vaccine and therapeutic for HSV prevention and treatment, with preclinical development currently underway.
Theralase Technologies (TSXV:TLT)(OTCQB:TLTFF) announced that its interim clinical data has been selected for presentation at the 2025 American Urological Association (AUA) Annual Meeting in Las Vegas. The presentation will focus on their Phase II clinical study of light-activated TLD-1433 for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer.
The interim data shows promising safety and efficacy results, with some patients demonstrating a duration of response of 3+ years following a single treatment. The innovative Ruvidar™ technology aims to provide an alternative to radical cystectomy for patients who have exhausted standard treatment options.
The company plans to complete patient enrollment in 2025, submit clinical data to Health Canada and FDA in 2026, and aims for commercial availability by 2027, pending regulatory approval.
Theralase Technologies has launched three new US-based Clinical Study Sites for its bladder cancer registrational clinical study. The sites include Associated Medical Professionals of NY, Urology of Indiana, and Central Ohio Urology Group. The company's Phase II registration study for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer has enrolled and treated 75 patients to date.
Key clinical results show that 61.9% of patients demonstrated a Complete Response, with Total Response reaching 68.3%. For duration of response, 43.6% of treated patients maintained Complete Response for at least 12 months. The safety profile shows 100% of patients experienced no Serious Adverse Events related to the treatment. According to Kaplan Meier estimates, patients achieving Complete Response have a ≥53.0% chance of remaining cancer-free for 1 year, ≥35.8% for 2 years, and ≥24.9% for 3 years.
Theralase Technologies has launched a new clinical study site at St. Joseph's Healthcare Hamilton for its bladder cancer therapy. The company's Phase II registration study investigates RuvidarTM (TLD-1433) activated by the TLC-3200 Medical Laser System for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer.
Key results from 75 enrolled patients show: 61.9% demonstrated Complete Response (CR), increasing to 68.3% when including Indeterminate Response. 43.6% of CR patients maintained response for 12 months, with some showing continued response at 24 and 36 months. The study reported 100% safety with no serious adverse events.
The company now operates 11 clinical sites across North America, with 4 more planned for Q4 2024/Q1 2025. Theralase is seeking partnering opportunities for international commercialization of Ruvidar™, targeting regulatory approval in 2026.
Theralase Technologies released its Q3 2024 financial statements, reporting a 12% year-over-year decrease in total revenue. The company's gross margin was 47% of revenue ($290,848), with cost of sales at 53% ($332,136). The net loss for the nine-month period was $3,337,995, with the Drug Division representing 84% of this loss. The company completed multiple non-brokered private placements throughout 2024, raising approximately $3.9 million. In Study II clinical trials, 61.9% of evaluable patients achieved Complete Response, with 43.6% maintaining response for at least 12 months. The company plans to complete enrollment in 2025 and aims for FDA and Health Canada approval by end of 2026.
Theralase Technologies, a clinical stage pharmaceutical company, has closed a non-brokered private placement offering, issuing 2,221,334 Units at $CAN 0.30 per Unit for total gross proceeds of $CAN 666,400. Each Unit includes one common share and one warrant, with warrants exercisable at $CAN 0.45 per share for 5 years. The proceeds will support the ongoing Phase II Non-Muscle Invasive Bladder Cancer clinical study, preclinical research of Rutherrin, working capital, and general corporate purposes. The securities are subject to a four-month hold period expiring March 16th, 2025.
Theralase Technologies, a clinical stage pharmaceutical company focused on light, radiation, sound and drug-activated molecules for cancer and pathogen treatment, announced plans to extend the expiry date of 1,000,000 share purchase warrants. The warrants, originally issued on November 17, 2022, through a private placement, will be extended from November 17, 2024, to November 17, 2027. The warrants remain exercisable at $0.35 per share, with all other terms unchanged. The extension requires TSX Venture Exchange approval.
Theralase Technologies Inc. (TSXV:TLT)(OTCQB:TLTFF) has successfully closed a Non-Brokered Private Placement (NBPP) offering, issuing 2,720,000 Units at $CAN 0.20 per Unit for gross proceeds of $CAN 544,000. Each Unit includes one common share and one warrant, exercisable at $CAN 0.30 for 5 years. The proceeds will fund the ongoing Phase II Non-Muscle Invasive Bladder Cancer clinical study, Rutherrin® preclinical research, working capital, and general corporate purposes.
Additionally, the company has granted 12,340,000 stock options to directors, officers, and employees, exercisable at $CAN 0.25 per share, vesting over three years with a five-year expiration. The securities are subject to a four-month hold period, expiring on January 25th, 2024, and the offering awaits final TSX Venture Exchange acceptance.
Theralase Technologies Inc. (TSXV:TLT)(OTCQB:TLTFF), a clinical stage pharmaceutical company, has announced its proposal to extend the expiry date of 10,000,000 share purchase warrants. The warrants, originally issued on September 22, 2022, as part of a private placement, were set to expire on September 22, 2024. The company now proposes to extend this expiry date to September 22, 2027. These warrants are exercisable at $0.35 per share, and all other terms and conditions will remain unchanged. The extension is subject to final acceptance by the TSX Venture Exchange.
Theralase Technologies Inc. (TSXV:TLT)(OTCQB:TLTFF) has announced that its lead drug formulation, Ruvidar, has shown superior effectiveness in destroying the Herpes Simplex Virus 1 (HSV-1) compared to the current standard treatment, Acyclovir. In preclinical studies, Ruvidar demonstrated the ability to inhibit HSV-1 replication by over 10 million-fold, even when administered one day after infection. This breakthrough could lead to the development of novel broad-spectrum antiviral approaches for both prevention and treatment of various viral diseases. The company is now seeking partnerships and licensing opportunities for the commercial development of Ruvidar as a potential topical and oral treatment for herpes simplex.