Theralase Technologies Inc (TLTFF)

[123414]

$TLTFF an additional three subjects out of the 11 without 2dose
Published Sept 1, 2021

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.


Uddin also commented on a recent event from competitor Sesen Bio, which on August 13 received a complete response letter (CRL) from the US FDA on a BLA for its Vicineum in BCG- unresponse NMIBC. Uddin related that Sesen aims to meet with the FDA in the fourth quarter of this year to get better clarity on next steps. The analyst said the announcement could open a potential window of opportunity for TLT, saying,

“On August 18th, a report by STAT News, which was based on SESN’s internal documents obtained by STAT, stated SESN’s pivotal trial with Vicineum had thousands of violations of study rules, investigator misconduct and worrying signs of toxicity SESN did not publicly disclose,” Uddin wrote.

At press time, Uddin’s $0.70 target represented a projected one-year return of 233 per cent.

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