A new development at Theralase (TSXV:TLT) has Echelon Wealth Partners analyst maintaining his bullish stance on the stock.
Theralase today announced that it had submitted a clinical trial application and investigational testing authorization for its TLD-1433 anti-cancer technology to Health Canada for review and approval.
“The submission of a CTA and ITA to Health Canada for the study marks completion of another major milestone for the company on our way to proving the efficacy of our anti-cancer technology in the destruction of NMIBC, interim CEO Arkady Mandel said. “Pending approval of the CTA, ITA and REB, along with securing the required financing, Theralase plans to authorize select Canadian oncology location(s) and their respective principal investigator(s) to commence enrolling and treating NMIBC patients using our approved clinical treatment procedure.”
Loe says this is still as wait-and-see type of situation, but there are reasons to be optimistic.
“ON-based laser therapeutics and photodynamic therapy developer Theralase formally established to its own satisfaction a clinical study design for testing its oligothiophene-based ruthenium centered PDT drug TLD-1433 in a fairly large & rigorous Phase II non-muscle invasive bladder cancer (NMIBC) trial,” the analyst explained. “The announcement today is on details that Theralase will submit to Canadian regulators for endorsement, and so there is still some risk that details could be refined in material ways, but core details look reasonable to us and are consistent with other bladder cancer studies (even pivotal Phase III studies) that Theralase’s peers have conducted before. We will delve into a few of the salient study design elements below, but our key takeaway is that the TLD-1433 program is advancing to our expectations and the drug remains the primary driver in our model and valuation.”
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In a research update to clients today, Loe maintained his “Speculative Buy” rating and one-year price target of $0.50 on Theralase, implying a return of 28.2 per cent at the time of publication.
Loe thinks TLT will post EBITDA of negative $6.2-million on revenue of $12.9-million in fiscal 2022. He expects those numbers will improve to EBITDA of positive $7.8-million on a topline of $25.3-million the following year.