Theralase Technologies Inc. V.TLT

Alternate Symbol(s): TLTFF

Healthcare Medical Devices

Theralase Technologies Inc. is a Canada-based clinical-stage pharmaceutical company. The Company is engaged in the research and development of light activated compounds and their associated drug formulations. The Company operates through two divisions: Anti-Cancer Therapy (ACT) and Cool Laser Therapy (CLT). The Anti-Cancer Therapy division develops patented, and patent pending drugs, called Photo Dynamic Compounds (PDCs) and activates them with patent pending laser technology to destroy specifically targeted cancers, bacteria and viruses. The CLT division is responsible for the Company’s medical laser business. The Cool Laser Therapy division designs, develops, manufactures and markets super-pulsed laser technology indicated for the healing of chronic knee pain. The technology has been used off-label for healing numerous nerve, muscle and joint conditions. The Company develops products both internally and using the assistance of specialist external resources.

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Theralase Technologies Inc. > Latest TLD1433 shout-out

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Comment by johannnon Dec 15, 2024 1:19pm

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RE:RE:RE:RE:RE:Latest TLD1433 shout-out

Theralase® is a clinical-stage pharmaceutical company that is in the process of completing a Phase II registration clinical study for bladder cancer.

Given recent developments, including the clinical results released last week and announcements of a $250 million capital raise by CG Oncology and the $100 million raise by ImmunityBio, we wanted to share our perspective on CG Oncology’s clinical study and how it compares to Theralase®’s ongoing advancements.

As you are most likely aware, CG Oncology reported out last Thursday and although their clinical data was strong (Initial CR of 74.5%, duration of CR at 12 months of 50.0% and at 24 months 30.5%), they were required to pre-screen their patients for the Retinoblastoma (“Rb”) protein prior to enrollment and only accepted patients that demonstrated that Rb was negative.

https://clinicaltrials.gov/study/NCT01438112 - Inclusion Criteria #17 - “Patient to provide a tumor specimen for determination of RB pathway status”

Unfortunately, in high-grade disease (which CIS, always is), Rb negative only occurs in 25% of high-grade bladder cancer patients; hence, their therapy will only address 25% of the CIS population (and only after screening, which not all facilities are equipped to do), which begs the question as to who will treat the remaining 75%.

Retinoblastoma gene mutations in primary human bladder cancer - PMC

Theralase® with an initial CR of 61.9% (Total Response of 68.3%), duration of CR at 12 months of 43.6%, at 24 months 35.8% (KM estimate) and at 36 months 24.9% (KM estimate) provides a logical solution.

Please click on the link below to view our updated corporate power point presentation detailing how Theralase® sits in comparison to its competitors on slides 22 and 23.

Clinical Results & Corporate Presentation here

Theralase® is able to address the entire BCG-Unresponsive NMIBC CIS population with durations of CR equivalent or superior to CG Oncology.

Theralase® Key Investment Highlights:

Clinical Progress: The enrollment phase of the clinical study is nearing completion, with patient enrollment expected to conclude in 2025, data lock in mid 2026 and Health Canada / FDA approval in late 2026.
Outstanding Results: Preliminary data exceeds International Bladder Cancer Group (IBCG) benchmarks recognized by the FDA for recent commercial approvals.
Accessible to Entire Patient Population: Theralase® is able to address the entire BCG-Unresponsive NMIBC CIS population with durations of compete response (CR) equivalent or superior to CG Oncology’s treatment. Notably, CG Oncology’s recently published results, although strong, apply to only 25% of the patient population, highlighting Theralase®’s broader impact potential.
Market Opportunity: Competitors in the clinical-stage bladder cancer treatment space boast market caps up to 60x larger, indicating substantial upside potential.
Analyst Confidence: Analysts rate Theralase® as a “Buy” with a target price >300% above the current valuation.