Theralase Technologies Inc Stock Price, News & Analysis

Theralase Technologies (TSXV: TLT) (OTCQB: TLTFF) has released its 2024 financial statements, reporting a 3% decrease in total revenue to $1,033,431 compared to 2023. The company achieved a gross margin of 54%, with cost of sales at $479,406.

Key financial metrics show decreased expenses across multiple categories: administrative expenses fell 9% to $1,734,066, and research and development expenses decreased 8% to $2,735,674. The company reported a net loss of $4,256,114 for 2024, with the Drug Division accounting for 84% of the loss.

In clinical developments, the company has treated 79 patients in Study II, with promising results: 62.5% of evaluated patients demonstrated Complete Response (CR), and 45% of those maintained CR for at least 12 months. The company plans to complete Study II enrollment by mid-2025. Additionally, Theralase is collaborating on Parkinson's Disease treatment research and advancing studies in GlioBlastoma Multiforme and Herpes Simplex Virus treatment applications.

Theralase Technologies (TSXV: TLT) (OTCQB: TLTFF) has successfully closed a non-brokered private placement offering, raising CAD $310,200 through the issuance of 1,034,002 units at CAD $0.30 per unit. Each unit includes one common share and one warrant, with warrants exercisable at CAD $0.45 per share for 5 years.

The proceeds will support the company's ongoing Phase II Non-Muscle Invasive Bladder Cancer (NMIBC) clinical study, preclinical research and development of Rutherrin®, working capital, and general corporate purposes. The offering included participation from company insiders, who subscribed for 251,668 units totaling CAD $75,500.

A broker's fee of CAD $1,728 and 2,880 non-transferrable broker warrants were paid in connection with the offering. All securities issued are subject to a four-month hold period expiring July 12th, 2025.

Theralase Technologies (TLTFF) has announced promising interim clinical data showing improvements in both motor and non-motor function for Parkinson's Disease (PD) patients treated with their TLC-2400 Cool Laser Therapy (CLT) system.

In a triple-blind, randomized controlled study at the University of Windsor, patients received 7 treatments over 3 weeks using either active or placebo CLT systems. Key findings include:

• 11% increase in cognitive assessment scores with active treatment vs 4% with placebo
• 14% improvement in brain blood flow with active treatment vs 1% with placebo
• 19% improvement in fine motor control with active treatment vs 6% with placebo
• 9% improvement in orthostatic tolerance with active treatment vs no change with placebo

The study demonstrates that Theralase's CLT technology can non-invasively penetrate the human skull, promoting anti-inflammatory responses and stimulating dopamine production. This research is particularly significant as PD affects 1 million Americans, with treatment costs reaching $52 billion annually.

Theralase Technologies (TLTFF) has announced significant breakthroughs in treating Non-Hodgkin's Lymphoma (NHL) using their lead compound Rutherrin®. In a preclinical study, Rutherrin® demonstrated effective destruction of NHL when combined with Metformin and radiation in an animal model.

The research utilized A20 mouse lymphoma cells in a highly aggressive tumor model. The treatment protocol involved:

• Rutherrin® administered intravenously 3 times per week
• Daily Metformin injections
• Radiation 5 times per week

The most notable results came from the trimodal therapy combining all three treatments, which led to the best overall response, including one case of complete tumor regression with the mouse remaining tumor-free. NHL represents a significant market opportunity, with global market estimates reaching $16.5 billion by 2031. The disease affected approximately 544,000 new cases globally in 2020, resulting in 260,000 deaths.

Theralase Technologies (TSXV:TLT)(OTCQB:TLTFF) has successfully validated previous University of Manitoba research, demonstrating that Ruvidar™ is safe and effective in treating Herpes Simplex Virus Type 1 (HSV-1) in an animal model.

The research involved Balb/C mice infected with human HSV-1 virus. A 1% Ruvidar solution was applied topically to developed lesions once daily for 4 days, resulting in complete healing of the HSV-1 cutaneous lesions.

This breakthrough comes amid significant market opportunity, with the global HSV treatment market valued at $2.5 billion in 2023 and expected to grow at 8.1% CAGR from 2024 to 2030. Currently, an estimated 3.8 billion people under age 50 globally have HSV-1, while 520 million aged 15-49 have HSV-2. North America holds the largest market share at 32.4%.

Based on these successful results, Theralase plans to develop both a vaccine and therapeutic for HSV prevention and treatment, with clinical development to follow.

Theralase Technologies has validated previous University of Manitoba research, demonstrating that Ruvidar™ is safe and effective in treating Herpes Simplex Virus Type 1 (HSV-1) in an animal model. The research showed complete healing of HSV-1 cutaneous lesions in Balb/C mice after four days of treatment with a 1% Ruvidar solution.

The global HSV treatment market was valued at $2.5 billion in 2023, with an expected CAGR of 8.1% from 2024 to 2030. North America holds the largest market share at 32.4%. An estimated 3.8 billion people under age 50 globally have HSV-1, while 520 million people aged 15-49 have HSV-2.

Based on these successful results, Theralase plans to develop both a vaccine and therapeutic for HSV prevention and treatment, with clinical development to follow.

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.