-Catalent to Support Gene Therapy Manufacturing for SPG50 and Other Pipeline Programs-

Elpida Therapeutics, a non-profit biotechnology company developing gene therapies for ultra-rare diseases, and Catalent, Inc., the leader in enabling the development and supply of better treatments for patients worldwide, today announced a strategic partnership to support late-phase manufacturing of Elpida’s lead program, an AAV9 gene therapy for Spastic Paraplegia Type 50 (SPG50). Under the agreement, Catalent will also be granted exclusive manufacturing rights to Elpida’s other pipeline adeno-associated virus (AAV) gene therapy programs.

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SPG50 is an ultra‑rare neurodegenerative disorder caused by AP4M1 mutations, beginning in infancy. Untreated, the disorder leads to cognitive impairment, epilepsy and progressive paralysis by early adulthood.

“This collaboration with Catalent represents a critical step in ensuring continued patient access to our SPG50 gene therapy program. Without this support, the final patient planned for treatment by the end of this year could have marked the end of this therapy’s availability,” said Terry Pirovolakis, Founder and Chief Executive Officer, Elpida Therapeutics. “Together, we are building a path to reach all patients living with SPG50 and, ultimately, other devastating ultra-rare diseases.”

“This partnership reflects Catalent’s commitment to applying our broad gene therapy manufacturing expertise and Patient First approach to programs with significant unmet need,” said David McErlane, Biologics Group President for Catalent. “By leveraging our broad expertise in end‑to‑end AAV capabilities, we look forward to supporting Elpida’s SPG50 program through late‑phase manufacturing so it can advance toward regulatory submission.”

Catalent will utilize its industry-leading UpTempo^TM AAV manufacturing platform, incorporating its proprietary HEK293 cell line, pre-validated off-the-shelf AAV plasmids, and pre-qualified analytical assays, to accelerate the production of R&D and GMP-grade material required for SPG50 process validation and to assist Elpida with its Biologics License Application submission. Catalent has partnered with clients on over 80 gene therapy programs, including four commercial programs to date, from early development through all clinical stages and commercialization.

About Catalent

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) championing the missions that help people live better and healthier lives. Every product that Catalent helps develop, manufacture and launch reflects its commitment to improve health outcomes around the world through its Patient First approach. Catalent provides unparalleled service to pharma, biotech and consumer health customers, delivering on their missions to transform lives. Catalent tailors end-to-end solutions to meet customers’ needs in all phases of development and manufacturing. With thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. For more information, visit www.catalent.com.

About Elpida Therapeutics

Elpida Tx's mission aims to address the current and significant unmet medical needs of patients with ultra-rare diseases. Through leveraging scientific advancements and the now well-established safety and understanding of certain gene therapies, Elpida Tx a Non-Profit aims to put cures in reach of families and children who desperately and urgently need them. Elpida Tx's business model focuses on partnerships that promote efficiency and the chance to treat a greater number of patients, while being self-sustaining and replicable. Elpida Tx specifically focuses on advancing programs that traditional biotech companies find difficult to bring through to completion. The company pipeline includes programs that were deprioritized by biotech companies or that did not receive biotech investment to advance due to small patient populations, but which have excellent scientific data on which to build a program and springboard the science and opportunity.

For more information go to www.Elpidatx.com.

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“This partnership reflects Catalent’s commitment to applying our broad gene therapy manufacturing expertise and Patient First approach to programs with significant unmet need,” said David McErlane, Biologics Group President for Catalent.