Theralase Technologies Inc. V.TLT

RE:potential Breakthrough Designation Approval

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$TLTFFOn the preliminary results, Theralase said,

“The current interim analysis of the clinical data (with significant clinical data still pending and based on only 27 patients) demonstrates that Study II’s primary (33.3 per cent) and tertiary objectives (1 Severe AE) demonstrate a strong initial efficacy, strong durable efficacy and a high safety profile. There is insufficient data to comment on the Study II secondary objective,” the company stated in the August 30 press release.

Commenting on the quarter and preliminary results, Uddin said with the TLD-1433 still in Phase 2, financials are less important for TLT at the moment.

On the Phase 2 study, Uddin said, “TLT reported an interim analysis across a treatment period of 450 days based on the 24 subjects and three subjects from the previous Phase 1b trial treated at the therapeutic dose. At 90 days of treatment, 33.3 per cent of the 27 subjects (nine) achieved CR, which decreased to 18.5 per cent (5) at 270 days and 11.1 per cent (3) at 360 days. We believe what is most important with this preliminary dataset is that at 270 & 360 days, there were 37.0 per cent (10) and 40.7 per cent (11) of the 27 subjects which had not received both doses of TLD-1433.”

On the comparison with Merck’s Keytruda, which has been approved for BCG-unresponsive NMIBC and has achieved a 19 per cent complete response at 12 months of treatment in the pivotal KEYNOTE-057 study, Uddin wrote,

“For the 27 subjects in TLT’s pivotal trial to achieve the same CR rate at 360 days as Keytruda, an additional three subjects out of the 11 which had not received both doses of TLD-1433 would need to achieve CR – representing a 27 per cent threshold (3/11) – we believe this is a feasible threshold for Theralase given the data presented to date,” Uddin said.

“As the Phase 2 pivotal trial continues to progress, we believe the results should elucidate the efficacy potential of TLT-1433. We are maintaining our SPECULATIVE BUY rating and a target price of $0.70,” Uddin wrote.

https://www.cantechletter.com/2021/09/theralase-technologies-has-a-233-per-cent-upside-says-research-capital/#