IRulya Therapeutics Inc 8-K, filed Oct 17, 2025
IRulya Therapeutics Inc. (IRLA)
About this 8-K
IRulya Therapeutics Inc filed this 8-K on October 17, 2025.
Items reported
- Item 7.01: Regulation FD disclosure
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Item 7.01 Regulation FD Disclosure.
Quince Therapeutics, Inc. (the “Company”) hosted a Virtual Investor Day on October 2, 2025 (“Investor Day”). In connection with Investor Day, the Company displayed a slide deck (“Investor Day Presentation”). At slide 57 of the Investor Day Presentation, Quince stated the following regarding IntraBio Inc.’s Phase 2 study for N-acetyl-L-leucine (“NALL”) in patients with ataxia-telangiectasia (the “IntraBio Phase 2 Study”): “Unknown efficacy in A-T; failed Phase 2 A-T study across all endpoints.” (“Quince’s Statement”). Quince’s Statement has been removed from the Investor Day Presentation and the accompanying video on YouTube. Investors should not rely on Quince’s Statement.
Quince’s Statement was based on an article regarding NALL that appears in the European Journal of Paediatric Neurology titled “Efficacy and safety of N-acetyl-L-leucine in patients with ataxia telangiectasia: A randomized, double-blind, placebo-controlled, crossover clinical trial” (“EJPN Article”); European Journal of Paediatric Neurology 50 (2024) 57–63 (https://www.ejpn-journal.com/article/S1090-3798(24)00055-2/abstract). The EJPN Article is not a publication based upon the IntraBio Phase 2 Study; rather, the EJPN Article relates to a single-site study of the efficacy and safety of NALL in patients with ataxia telangiectasia and states, in relevant part, that: (1) “Although patients’ nausea and constipation were improved, the results failed to reveal any significant benefits of NALL treatment on ataxia symptoms”; and (2) “Despite improvements in some symptoms, NALL intervention failed to improve motor function significantly”.
To the best of Quince’s knowledge, the EJPN Article is the only peer-reviewed publication relating to a Phase 2 efficacy study of NALL in A-T treatment.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| QUINCE THERAPEUTICS, INC. | ||||||
| Date: October 17, 2025 | By: | /s/ Dirk Thye | ||||
| Name: | Dirk Thye | |||||
| Title: | Chief Executive Officer and Chief Medical Officer | |||||