Kayz88 wrote: TLDR – It’s a small cap Canadian bio-tech company making cancer food. Cancer cells eat the food, light activates the food and destroys only the cancer cells leaving the good ones behind. Multiple applications for the drug, currently in Phase II of clinical trials and is about to submit for a
Breakthrough Designation from the FDA.
This is not financial/Investing advice. I am holding long-term. Please do your own Due Diligence. Overview Theralase Technologies Inc. is a Canadian-based biotechnology company specializing in the research, development, and commercialization patented Photo Dynamic Therapies to combat cancer. Their flagship product
TLD-1433 aka
Ruvidar is the lead drug that this post is focusing on.
What is it? It’s basically cancer food, the drug gets pushed into the bladder, the cancer eats it up (binds with it) and the drug gets activated through a trigger such as light or other drugs (infrared, radiation, sound, drug) and it neutralizes all of the cancer cells. This provides a major advantage as it leaves all the other cells healthy while only targeting the cancer cells. The treatment is also a one-and-done type of deal, no need for multiple visits or multiple treatments.
What cancer does it target? Currently the drug is being tested for
Non-Muscle Invasive Bladder Cancer (NMIBC) – with future plans to move into lung cancer, brain cancer and leukemia.
Where along the study is this drug? Currently in Phase II Clinical trials. Due to the design of the study and the unmet need for this sort of drug, there doesn’t appear to be a need for Phase III to get approved by the FDA. The current status is 75/100 patients enrolled and treated with a 53% response rate after the 1
st year (cancer free), 35.8% response rate after the 2
nd year and 24.9% after 3
rd year – This seems impressive when you put it against the FDA standards of 50% response rate at 6 months, 30% at 12 months and 25% after 18 months
Near-term Catalyst The near-term catalyst for this stock’s movement would be the submission and approval for a
Breakthrough Designation from the FDA. They recently submitted a pre-BTD application to the FDA at the end of November 2024 and received a response indicating that they needed to update the way they displayed their data, this reads as a positive sign for the following reasons:
- The FDA acknowledges this drug to a certain degree, otherwise they would’ve shot this down a long time ago
- The adjustments that they’re requesting isn’t additional data points or additional efficacy, it’s strictly to display the data differently
There should be a response on the go/no-go from the FDA by end of Q1 2025.
Implication for BTD The company is currently trading at a $71 million valuation for a drug that’s receiving a lot of positive response. Comparable companies with a similar drug in their pipeline are $CGON and $IBRX which trades at a $2 billion dollar valuation. $CGON is not FDA approved but has received the
Breakthrough Designation that
Ruvidar is applying for. Should the
Breakthrough Designation be greenlit from the FDA, the equivalent valuation would roughly be $5.00 to $5.75 per share, (fully diluted) this equates to a $2 billion valuation from today’s numbers. This would represent a 19x fold.
Rough math:
350,000,000 Shares outstanding fully diluted
$2,000,000,000 valuation (assuming only 1 treatment from Ruvidar)
$5.71 per share
Current share price: .29
Timelines 2012 - 2014: Theralase began research into ruthenium-based photodynamic compounds, identifying TLD-1433 as a promising candidate.
2015: Preclinical Animal Trials - TLD-1433 entered preclinical trials in rodent models to evaluate its safety, efficacy, and pharmacokinetics.
- Rat trials demonstrated the compound's ability to destroy bladder cancer cells upon activation with a specific wavelength of light, while sparing healthy tissues.
- Studies showed minimal systemic toxicity, reinforcing its potential as a localized cancer therapy.
2016: Advanced Preclinical Studies - Additional preclinical trials were conducted in larger animal models to prepare for regulatory submissions.
- These trials further confirmed the compound’s safety and tumor-selective phototoxicity.
2017: Initiation of Phase I Clinical Trials - Following successful preclinical trials, Theralase secured approval to begin Phase I human trials in patients with Bacillus Calmette-Gurin (BCG)-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC).
- Phase I trials focused on safety and tolerability, with promising preliminary results.
2020: Phase II Clinical Trials - Theralase initiated Phase II clinical trials to evaluate the efficacy of TLD-1433 in a larger patient population.
- The focus shifted to measuring therapeutic outcomes, such as recurrence-free survival rates.
2023: Fast Track Designation - On February 2, 2023, the U.S. FDA granted Fast Track Designation for TLD-1433, recognizing its potential to address unmet medical needs in NMIBC.
2024: Application for Breakthrough Therapy Designation - Theralase plans to submit a pre-BTD application in Q4 of 2024 as a way to ensure compliance with the BTD application in Q1 of 2025. The pre-BTD application was submitted in late November to which the FDA replied that the data needed to be shown differently to adhere to the BTD guidelines. An updated pre-BTD application was submitted in late December 2024, with response on go/no-go for BTD in early January 2025.
Forecast: 2026 - Soft and hard data lock for Phase II clinical trials
- Submit clinical data to health Canada and FDA
Forecast: 2027 - Commercialization for distribution in Canada and in the US.
Corporate Presentation https://rals-zgpm.maillist-manage.com/click/179343522c2b4b07/179343522c2b4a72 Website www.theralase.com