–  Collaboration combines Quell’s pioneering autologous multi-modular Treg cell therapy platform and Cellistic™’s expertise in iPSC cell therapy platform development and scale-up

–  Aims to accelerate the development of a next-generation allogeneic Treg platform that could open significant opportunities for Quell’s creation of off-the-shelf Treg cell therapies targeting a wide range of diseases driven by immune dysregulation

–  First announced collaboration for Cellistic™, Ncardia’s recently formed cell therapy process development and manufacturing services business

LONDON and GOSSELIES, BELGIUM (April 27, 2022) –Quell Therapeutics Ltd (“Quell”), a leader in developing engineered T-regulatory (Treg) cell therapies for serious medical conditions driven by the immune system, and Cellistic™, the iPSC-focused cell therapy process development & manufacturing partner recently launched by Ncardia to make large-scale allogeneic cell therapy production a reality, announce they have entered into a strategic collaboration for the co-development of an iPSC-derived Treg cell therapy platform. The goal of the partnership is to facilitate the future expansion of Quell’s autologous Treg cell therapy pipeline by adding off-the-shelf, allogeneic Treg cell therapy products, leveraging Cellistic™’s expertise in differentiation and scale-up of iPSC processes for allogeneic cell therapy applications.

Iain McGill, Chief Executive Officer, Quell Therapeutics, said: “Quell has made significant progress advancing the first candidate from our autologous multi-modular Treg cell therapy platform into the clinic, with the initiation of our LIBERATE study of QEL-001 to prevent liver transplant rejection. We believe there is significant opportunity to transform outcomes for patients with QEL-001 and other autologous Treg cell therapy products in our pipeline. Our collaboration with Cellistic™ is a key building block in our investment towards a future, next-generation allogeneic Treg cell platform, which could significantly expand our opportunities to develop novel off-the-shelf treatments across a wide range of diseases driven by immune dysregulation. We highly respect the expertise and experience of Ncardia and the Cellistic™ team, and its track record in developing rapidly scalable iPSC cell therapy processes.”

Stefan Braam, Chief Executive Officer, Cellistic™, said: “Our partnership with Quell is emblematic of why we started Cellistic™ – to bring together our focus and expertise in the development and implementation of iPSC cell therapy platforms with companies like Quell that have an equal depth of expertise in therapeutic development and share our vision for the future of cell therapy. We are excited to collaborate with the Quell team, both to develop the platforms, and to support Quell’s long-term supply needs as they deliver impactful therapeutics to patients.”

Under the terms of the agreement, Quell and Cellistic™ will collaborate in joint research to develop a process for differentiating iPSCs into highly functional Treg cell therapy products. Quell will contribute its Treg expertise and engineering technologies, as well as characterizing resulting Treg cells, while Cellistic™ will be responsible for the iPSC process science and development activities.

Based on a successful research phase, the collaboration will enter a product development phase with Quell having exclusive rights under the co-developed iPSC-Treg process for the development of multiple allogeneic iPSC-Treg cell therapeutics, and Cellistic™ as the exclusive CDMO partner for Quell’s iPSC-Treg product pipeline, leveraging Cellistic™’s ongoing investment in downstream GMP capabilities.

Tracey Lodie, Chief Scientific Officer, Quell Therapeutics, added: “We have learnt in cell therapy development that the continuity from the R&D phase into the manufacturing phase is a critical success factor in achieving robust, scalable cell product processes. Cellistic™ emerged as a best-in-class and complementary partner to enable our path to an iPSC Treg cell therapy platform, and its ongoing investment in GMP capabilities provides the potential for a long-term partnership to accelerate the future development of allogeneic Treg cell therapies for patients.

About Quell Therapeutics

Quell Therapeutics is the world leader in developing engineered T-regulatory (Treg) cell therapies that aim to harness, direct and optimize their immune suppressive properties to address serious medical conditions driven by the immune system.

The Company is leveraging its pioneering phenotype lock technology, unique multi-modular platform and integrated manufacturing capabilities to design and develop a pipeline of highly engineered Treg cell therapies with greater potential for persistence, potency and stability than earlier generations of Treg cell therapy approaches.

Quell’s lead candidate QEL-001 is being developed to induce operational tolerance following liver transplantation, with the potential to protect the post-transplant liver without the need for chronic immunosuppressive medications. Quell is also advancing additional programs in neuroinflammatory and autoimmune diseases. www.quell-tx.com.

About Cellistic™

Launched in April 2022, Cellistic™ specializes in process development and manufacture of cell therapies based on human induced pluripotent stem cell (iPSC) technology. Its focus and expertise in iPSC reprogramming, differentiation, and expansion protocol development positions the business to be the partner of choice for innovative cell therapy developers to commercialize novel advanced therapies. Leveraging more than a decade of Ncardia’s scientific and technical knowledge and experience, Cellistic™ possesses unique capabilities for the design and optimization of proprietary manufacturing platforms for iPSC-based cells that deliver quality products at scale. For more information, visit www.cellistic.com.

About Ncardia

Ncardia is a leader in contract research, development and manufacture of iPSC-based solutions for early and preclinical drug discovery. Its goal is to enable pharmaceutical and therapeutics companies to make more confident decisions in discovery and development by integrating iPSC technologies into their screening processes. Ncardia’s capabilities include disease modeling, manufacturing, assay development and high-throughput screening especially for cardiac and neurodegenerative diseases. Ncardia was founded in 2011 and is majority-owned by KINICITI a private equity-backed advanced therapies platform. For more information, visit www.ncardia.com