Quince Therapeutics to Acquire EryDel SpA and its Phase 3 Asset Targeting Ataxia-Telangiectasia with No Currently Approved Treatments and Estimated $1+ Billion Peak Sales Opportunity - Seite 2

Luca Benatti, EryDel’s Chief Executive Officer, said, “EryDel’s acquisition by Quince offers the opportunity to advance our innovative, point-of-care autologous intracellular encapsulation technology through development to commercialization and to fulfill our mission to provide the first treatment for patients living with the devastating disease of A-T. Quince’s effort will be supported by the encouraging Phase 3 data generated from EryDel’s prior international study of EryDex, which demonstrated a significant delay in disease progression in A-T patients and further supported more than 10 years of safety data. Quince is well-positioned to advance EryDel’s differentiated AIDE technology and development of our lead asset EryDex to deliver innovative treatments to patients in need.”

Transformative Acquisition with Value-Creating Clinical Milestones

Key highlights of the EryDel acquisition include:

Well-capitalized into 2026 with ability to fully fund lead asset EryDex expected through Phase 3 clinical trial under SPA and to NDA submission

• Strong balance sheet with approximately $87.6 million in cash, cash equivalents, and short term investments (unaudited) as of June 30, 2023, to provide funding for operating requirements into 2026.
• Capital efficient development plan allows for funding of EryDex through global Phase 3 clinical trial under SPA and, assuming positive study results, to NDA submission, in addition to pursuing European regulatory activities related to potential MAA submission.
• Potential to out-license ex-U.S. regional territories to provide runway through regulatory approval of EryDex.

Plan to enroll first patient in global Phase 3 trial of EryDex in second quarter of 2024 with NDA submission targeted by end of 2025

• SPA in place with FDA for a single global Phase 3 clinical trial of EryDex expected to be sufficient for NDA submission, assuming positive study results.
• EryDex designated as orphan drug for treatment of A-T from both the FDA and EMA.
• Phase 3 NEAT (Neurologic Effects of EryDex on Subjects with A-T) clinical trial is a planned double blind, randomized, placebo controlled, global efficacy study in approximately 86 A-T patients aged six to nine years-old with up to an additional 20 patients aged 10 years or older included for potential broader label support.
• Primary endpoint, as agreed upon with the FDA, to measure neurological function based on rescored modified International Cooperative Ataxia Rating Scale (RmICARS) from baseline to month six of treatment.
• Secondary endpoints to measure Clinical Global Impression scores for severity (CGI-S) and change (CGI-C), as well as EuroQol quality of life scoring.
• Plan to enroll first patient in Phase 3 NEAT clinical trial in the second quarter of 2024.
• Commercial version of EryKit treatment consumables approved in Europe and currently under partial clinical hold pending response to FDA query.
• Target EryDex NDA submission with the FDA by the end of 2025, assuming positive Phase 3 NEAT study results.

EryDex efficacy and safety profile demonstrated in prior Phase 3 clinical trial of A-T patients