Donein25 wrote: 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.
Learn more about our clinical study details
here! Regards,
Matthew
If you are interested in discussing our stock;
click here to book an appointment Matthew Perraton FMA, DFSA, Pro. Dir. Investor Relations
Theralase® Technologies (TSXV: TLT, OTCQB: TLTFF)