Sernova and Evotec enter into exclusive global strategic partnership for ‘functional cure’ for diabetes

Sernova and Evotec have entered into an exclusive global strategic partnership to develop a best-in-class cell therapy treatment for people living with insulin-dependent diabetes.

The two companies will combine and leverage their respective technologies and scientific expertise to develop an implantable iPSC-based (induced pluripotent stem cells) beta cell replacement therapy to provide an unlimited insulin-producing cell source to treat patients with insulin-dependent diabetes.

The collaboration agreement is a partnership that combines Sernova’s Cell Pouch System technologies, which has demonstrated Phase 1/2 clinical proof-of-concept using human donor islets, with Evotec’s iPSC-based beta cells. Incorporating Evotec’s insulin-producing, ethically-derived beta cells within Sernova’s Cell Pouch platform creates the potential to provide a ‘functional cure’ for millions of people suffering from diabetes using a cGMP controlled and scalable off-the-shelf product.

With its long-standing beta cell development program, Evotec has demonstrated the ability to reliably produce an unlimited supply of high quality, stable, human iPSC-derived beta cells using its proprietary process for producing islet-like clusters in a quality-controlled scalable bioreactor process. These islet-like clusters have now been proven to be functionally equivalent to primary human islets in their ability to normalize blood glucose using in vivo models of type 1 diabetes (T1D).

The partnership provides Sernova a global exclusive option to license Evotec’s iPSC-based beta cells for use in treating both type 1 and type 2 diabetes. In addition to entering into the collaboration agreement, Evotec has made a strategic equity investment of €15m and will make a further investment of €5m. Specifically, concurrently with the entering into the collaboration agreement, Evotec acquired a total of 12,944,904 common shares at a price of CAD $1.57 per share for gross proceeds to Sernova of $20,323,500.

In addition, pursuant to an unconditional purchase warrant, Evotec will acquire, on or before August 31, 2022, a further 2,709,800 common shares at a price of CAD$2.50 per share for gross proceeds of $6,774,500. All of the securities issued to Evotec are subject to a four month hold period.

Further to the collaboration and Evotec’s strategic equity investment, Dr. Cord Dohrmann, Chief Scientific Officer of Evotec will join Sernova’s Board of Directors.

Dr. Philip Toleikis, President, and Chief Executive Officer of Sernova, said: “In tandem with our current clinical islet cell program, Sernova entered into multiple pharmaceutical research collaborations to identify the highest quality and most compatible iPSC cell technology, and validate the cells preclinically within our Cell Pouch System. Evotec is an iPSC powerhouse having dedicated many years and substantial resources to developing high quality and stable stem cell technologies for multiple therapeutic applications.

“In every sense, both as a global strategic partner and as an iPSC expert, Evotec has exceeded all our expectations and Dr. Dohrmann’s appointment to Sernova’s Board adds significant regenerative medicine depth and cell therapy expertise. Today’s announcement of this joint iPSC beta-cell partnership completes the three pillars of our diabetes cell therapy platform. Alongside our clinically validated Cell Pouch System and recently acquired conformal coating immune protection technology, this now establishes a total regenerative medicine cell therapy solution for insulin-dependent diabetes.”

Dr Cord Dohrmann, Chief Scientific Officer of Evotec, said: “We searched long and hard for the right partner. Sernova clearly ticks all boxes with their clinically validated Cell Pouch™ technology, which fits perfectly to Evotec’s iPSC-based beta cells. Together we will progress a highly differentiated first-in-class beta cell therapy into clinical development with the common goal to bring a truly transformative therapy to insulin- dependent diabetic patients.

“The synergies of Evotec’s and Sernova’s technologies puts Sernova in position to become the world’s leader in beta cell replacement therapy. Our equity investment underlines our strategic interest in this collaboration with Sernova. I am very much looking forward to collaborating with Sernova on the project as well as contributing to their Board of Directors.”

Sernova has acquired an option for an exclusive global license to Evotec’s Induced Pluripotent Stem Cell (iPSC)-based Beta cells to treat patients with insulin-dependent diabetes. From an operational perspective, the preclinical development program(s) will be jointly funded by Sernova and Evotec until IND acceptance. Sernova has the right to exercise its option for an exclusive global license upon IND filing.

Evotec will contribute its cell manufacturing capabilities through research, development and product commercialization and will decide in the future on the joint funding of clinical development. Upon commercialization, there will be a profit-sharing arrangement between the two companies, with the split being dependent on Evotec’s participation in funding the clinical development program.

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