Hanall Biopharma (009420.KS) announced the Phase 3 clinical failure of batoclimab (IMVT-1401), yet analysts forecast the impact on the company's valuation will be limited. The clinical failure was a foreseen event, and the trial process yielded evidence that raises the probability of clinical success for a next-generation drug candidate.
NH Investment & Securities said in a report on Saturday that batoclimab had already been excluded from Hanall Biopharma's valuation, meaning the result will have no impact on the company's future business.
Hanall Biopharma disclosed on Friday that the top-line results of its Phase 3 trial of batoclimab, an autoimmune disease treatment tested on patients with thyroid eye disease (TED), failed to achieve statistical significance. However, the trial still carried meaningful implications. The safety and tolerability profile was consistent with results from the earlier Phase 3 trial in myasthenia gravis and the Phase 2 trial in Graves' disease, with no additional serious adverse effects identified.
"IMVT-1401 had been a drag on the stock price due to safety concerns and the possibility of the drug being returned, but with TED, all Phase 3 results have now been announced," said Han Seung-yeon, a researcher at NH Investment & Securities. "It is now time to focus on the new compound IMVT-1402, which has data readouts expected in the second half of this year." IMVT-1402 is a follow-up compound developed by Hanall Biopharma to improve upon batoclimab, targeting autoimmune diseases.
Park Jong-hyun, a researcher at Daol Investment & Securities, also assessed that while the Phase 3 trial failed to demonstrate efficacy for batoclimab, it provided grounds for raising the probability of success for IMVT-1402's registrational trial in Graves' disease (GD). "We are raising our probability of success for IMVT-1402 in GD from 55% to 62%," Park said, maintaining a "buy" rating and a target price of 64,000 won.
