Is Theralase Technologies (TSXV:TLT) a buy right now?

Research Capital analyst Andre Uddin says Theralase Technologies’ (Theralase Technologies Stock Quote, Chart, News, Analysts, Financials TSXV:TLT) key catalyst remains the regulatory filing and potential approval of Ruvidar for non-muscle invasive bladder cancer.

On Aug. 31, Uddin maintained his “Speculative Buy” rating and $0.70 target on Theralase.

Theralase reported Q2 revenue of $164,000 from cool laser therapy sales, in line with Uddin’s $180,000 estimate and down from $220,000 a year earlier.

Net loss was $1.1-million, or less than one cent per share, in line with Uddin’s forecast and compared with a loss of $1.0-million a year earlier.

Theralase ended Q2 with $5.3-million of cash and no long-term debt. After quarter-end, the company raised $3.6-million through a LIFE offering led by Research Capital, lifting Uddin’s estimated cash position to about $7.5-million.

Uddin said that should give Theralase enough cash runway into 2027, when Ruvidar is expected to launch if approved.

All 95 patients have completed enrollment in the company’s Phase 2 trial for non-muscle invasive bladder cancer. Of those, 82 have completed the study and 13 are awaiting clinical follow-up.

Management expects to submit a New Drug Submission to Health Canada and a New Drug Application to the FDA in Q3 2026, with regulatory decisions expected in 2027.

Uddin said Ruvidar’s clinical results and ease of administration as a potential one-and-done therapy support his optimism around approval.

Theralase also plans to study Ruvidar in additional cancers and infectious diseases, with toxicology studies expected by Q4 2026 and a potential clinical trial in 2027.

Uddin said an FDA filing for BCG-unresponsive non-muscle invasive bladder cancer could be a significant catalyst for the stock.

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