Quince Therapeutics to Acquire EryDel
July 24, 2023
Forward-looking statements
Statements in this presentation contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 as contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the "safe harbor" created by those sections. All statements, other than statements of historical facts, may
be forward-looking statements. Forward-looking statements contained in this news release may be identified by the use of words such as
"believe," "may," "should," "expect," "anticipate," "plan," "believe," "estimated," "potential," "intend," "will," "can," "seek," or other similar words. Examples of forward-looking statements include, among others, statements relating to Quince's acquisition of EryDel; the timing of the closing of the transaction; the expected benefits of the transaction, including the continued current and future clinical development and potential expansion of EryDel assets, related platform, and related timing and costs; the strategic development path for EryDex; planned FDA and EMA submissions and clinical trials and timeline, prospects, and milestone expectations; the timing and success of the
clinical trials and related data, including plans and the ability to initiate, fund, conduct and/or complete current and additional studies; the
potential therapeutic benefits, safety, and efficacy of EryDex; statements about its ability to obtain, and the timing relating to, further development of EryDex, regulatory submissions and interactions with regulators; therapeutic and commercial potential; the integration of EryDel's business, operations, and employees into Quince; Quince's future development plans and related timing; its cash position and projected cash runway; the company's focus, objectives, plans, and strategies; and the ability to execute on any strategic transactions. Forward-looking statements are based on Quince's current expectations and are subject to inherent uncertainties, risks, and assumptions
that are difficult to predict and could cause actual results to differ materially from what the company expects. Further, certain forward-
looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, but are not limited to, the risks and uncertainties described in the section titled "Risk Factors" in the company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on May 15, 2023, and other reports as filed with the SEC. Forward-looking statements contained in this news release are made as of this date, and Quince undertakes no duty to update such information except as required under applicable law.
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Transformative acquisition with value-creating clinical milestones
Phase 3 lead asset EryDex targets Ataxia-Telangiectasia(A-T) with no currently approved treatments and estimated $1+ billion peak sales opportunity
EryDex designed for controlled, slow release of dexamethasone over several weeks without long-term toxicity typically associated with chronic steroid administration
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, assuming positive study results
Well-capitalized into 2026 with ability to fully fund EryDex expected through Phase 3 trial and to NDA submission, assuming positive study results
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EryDel significant achievements
20+ years of work on autologous intracellular drug encapsulation (AIDE) technology platform
$100+ million invested since founding out of University of Urbino, Italy
EryDex designated as orphan drug for A-T treatment from FDA and EMA
Special protocol assessment (SPA) in place with FDA for single Phase 3 clinical
trial of EryDex - sufficient for NDA submission, assuming positive study results
EryDex efficacy and safety profile demonstrated in prior Phase 3 clinical
trial of A-T patients
Open label extension (OLE) and compassionate use data demonstrates up to 10+ years of chronic steroid administration without typical safety issues
Headquarters
- Bresso, Italy
Manufacturing
- Medolla, Italy
Leadership
- Luca Benatti: CEO
- Guenter Janhofer: CMO
- Giovanni Mambrini: COO
- Thomas Sabia: CCO
Employees
- 21
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EryDel acquisition transaction details
Stock-for-stock upfront exchange of Quince stock and potential downstream milestone cash payments of up to $485 million
- Up to $5 million in development milestones
- $25 million at NDA acceptance
- $60 million in approval milestones
- $395 million in market and sales milestones
- No royalties paid to EryDel stockholders
Overview
Unanimously approved by both companies' Board of Directors
EryDel stockholders to own maximum of approximately 16.7% of combined company - subject to downward adjustment
Governance & Leadership
David Lamond remains Chairperson of Quince Board of Directors
Dirk Thye remains Quince Chief Executive Officer and Director
Quince Board of Directors expanded with addition of EryDel representative Luca Benatti
Structure
EryDel to operate as wholly owned subsidiary of Quince with ongoing presence in Italy
Retain EryDel team and keep organization intact
Assumption of $13 million (€10 million principal) EIB loan with scheduled payments beginning in the second half of 2026
Approvals & Closing
Subject to certain regulatory approvals and other closing conditions
Expected to close in third quarter 2023
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Disclaimer
Quince Therapeutics Inc. published this content on 24 July 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 24 July 2023 11:02:22 UTC.