Source: Theralase.
  • Theralase is a clinical-stage biopharmaceutical company pioneering personalized Anti-Cancer Therapy (ACT) based on individual tissue characteristics
  • The company has successfully demonstrated strong safety and a 67-per-cent complete response rate for patients treated at the therapeutic dose with TLD-1433, its lead photodynamic compound, during a Phase Ib non-muscle invasive bladder cancer (NMIBC) clinical study
  • Management estimates the market opportunity for NMIBC between $1.1 and $5 billion annually

The TSX, TSXV, CSE and NEO exchanges list over 4,000 companies, which is a daunting number for any investor to sort through.

Parsing prospective opportunities from also-rans begins with narrowing down your investable universe, leaving only companies whose value propositions mark a clear path forward.

In the interest of expediting that task for TMH readers, our new series, Anatomy of a Flagship Asset, seeks to introduce you to the most promising projects and products making waves in the Canadian stock market.

A niche focus with billion-dollar potential

Theralase is a clinical-stage biopharmaceutical company pioneering personalized Anti-Cancer Therapy (ACT) based on individual tissue characteristics.

The company’s patented technology seeks to employ light-activated photodynamic compounds (PDCs) and their associated drug formulations to safely destroy cancer cells, with a particular focus on bladder cancer.

The non-toxic, light-sensitive compounds are absorbed by cancer cells, and laser-light activated to produce a violent form of oxygen known as singlet oxygen, which induces natural cell death in the cancer cells.

On the road to commercializing PDCs, Theralase successfully demonstrated strong safety and a 67-per-cent complete response rate for patients treated at the therapeutic dose with TLD-1433, the company’s lead PDC, during a Phase Ib non-muscle invasive bladder cancer (NMIBC) clinical study.

Phase II clinical study has been underway since November 2020 in Canada and the U.S. under the FDA’s Fast Track Designation.

The treatment is envisioned as a more efficient option compared to standard intravesical Bacillus Calmette Guérin (BCG) treatment, which produces a 30-per-cent cancer recurrence rate within 1 year in the U.S., Canada and Europe, with patients becoming unresponsive to further treatment.

Management estimates the market opportunity for NMIBC between $1.1 and $5 billion annually, with bladder cancer having the highest lifetime treatment costs per patient of all cancers.

Future catalysts

Potential investors should follow the ongoing clinical study for what the FDA describes as “primary evidence of effectiveness to support a marketing application.”

This evidence includes a complete response rate over a 12-month period and controlled incidence and severity of adverse events in patients within 450 days post-primary study
treatment.

The company expects to begin its official commercialization phase for TLD-1433 this year, with FDA and Health Canada marketing approval projected for 2025.

Theralase (TLT) stock has been consistently range-bound between $0.20 and $0.40 for the past 8 years, which is evidence of investor confidence in 1) ACT’s go-to-market process and 2) the viability of the company’s recurring revenue from Cool Laser Therapy, which reduces pain and inflammation.


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