Evotec and Sernova Announce Exclusive Strategic Partnership for iPSC-based Beta Cell Replacement Therapy to Advance a ‘Functional Cure’ for Diabetes

• PARTNERSHIP LEVERAGES IPSC-BASED BETA CELLS FROM EVOTEC’S QRBETA INITIATIVE COMBINED WITH SERNOVA’S PROPRIETARY IMPLANTABLE CELL POUCH™ DEVICE
• THE GOAL IS THE DEVELOPMENT AND COMMERCIALISATION OF AN OFF-THE-SHELF BETA CELL REPLACEMENT THERAPY FOR INSULIN-DEPENDENT DIABETES
• EVOTEC MAKES STRATEGIC € 20 M EQUITY INVESTMENT IN SERNOVA
• EVOTEC/SERNOVA JOINT CONFERENCE CALL AND WEBCAST AT 8.30 AM EDT MAY 17, 2022

HAMBURG, GERMANY, and LONDON, ON / ACCESSWIRE / May 17, 2022 / Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) and Sernova Corp. (TSX-V: SVA; OTCQB: SEOVF; FSE: PSH), a clinical-stage company and leader in regenerative medicine cell therapeutics today announced a partnership in the field of diabetes. Both Companies will leverage their respective strengths to develop an implantable iPSC-based beta cell replacement therapy for the treatment of insulin-dependent diabetes, including type 1 and 2.

The partnership leverages iPSC-based beta cells from Evotec’s QRbeta initiative. Evotec reliably produces human iPSC-based beta cells in islet-like clusters in a quality controlled (“QC”) scalable bioreactor process. Those islet-like clusters are functionally equivalent to primary human islets in their ability to normalise blood glucose levels in in vivo models over several months.

Evotec’s iPSC-based beta cells will be combined with Sernova’s proprietary Cell Pouch™, which is the leading implantable and scalable medical device in its class. In particular, it enables vascularisation of the cell implant and thus ensures long-term survival and optimal function in patients. The combination of primary donor islets and Cell Pouch has achieved long-lasting therapeutic results in patients enrolled in Sernova’s US-based Phase I/II clinical trial, including sustained insulin-independence in high-risk Type 1 Diabetes patients who previously required insulin injections for survival. Moreover, Sernova will evaluate local immune protection technology to protect non-modified beta cells and avoid the requirement for immunosuppressive treatment. The goal of the partnership is the development of an off-the-shelf iPSC-based beta cell replacement therapy device for the treatment of patients living with insulin-dependent diabetes.

Sernova has acquired an option for an exclusive global license to Evotec’s Induced Pluripotent Stem Cell (iPSC)-based Beta cells for use with its Cell Pouch system to treat diabetes. From an operational perspective, the pre-clinical development programme(s) will be jointly funded until IND acceptance. Sernova has the right to exercise its option for an exclusive global license upon IND filing. Evotec will contribute cell manufacturing through commercialisation and decide in the future on joint funding of clinical development. Upon commercialisation, there will be a profit-sharing arrangement between the two companies, with the split dependent upon Evotec’s participation in the clinical development programme.

In conjunction with the agreement, Evotec has committed to a strategic € 20 m equity investment in Sernova (approx. CAD$ 27 m at an €/CAD$ fx rate of 1.355).

Dr Cord Dohrmann, Chief Scientific Officer of Evotec, commented: “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 operational 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. We are very much looking forward to collaborate with them on the project as well as to be part of their Supervisory Board.”

Dr Philip Toleikis, President, and Chief Executive Officer of Sernova, commented: “In tandem with our current clinical islet cell programme, Sernova entered into multiple pharmaceutical research collaborations to identify the highest quality and most compatible iPSC cell technology, and validate the cells pre-clinically 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 we welcome them to join our advisory board. 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.”

Sernova and Evotec are going to hold a joint conference call on the transaction. The conference call will be held in English.

Conference call details

Date: Tuesday, 17 May 2022
Time: 02.30 pm CEST (08.30 am EDT, 01.30 pm BST)

US Toll Free: 1-877-704-4453
International: 1-201-389-0920
Conference ID: 13730121

A simultaneous slide presentation will be available under the following link: https://viavid.webcasts.com/starthere.jsp?ei=1550130&tp_key=3de87cce1d

About Evotec and iPSC
Induced pluripotent stem cells (also known as iPS cells or iPSCs) are a type of pluripotent stem cell that can be generated directly from adult cells. The iPSC technology was pioneered by Shinya Yamanaka’s lab in Kyoto, Japan, who showed in 2006 that the introduction of four specific genes encoding transcription factors could convert adult cells into pluripotent stem cells. He was awarded the 2012 Nobel Prize along with Sir John Gurdon “for the discovery that mature cells can be reprogrammed to become pluripotent”. Pluripotent stem cells hold great promise in the field of regenerative medicine. Because they can propagate indefinitely, as well as give rise to every other cell type in the body (such as neurons, heart, pancreatic and liver cells), they represent a single source of cells that could be used to replace those lost to damage or disease.

Evotec has built an industrialised iPSC infrastructure that represents one of the largest and most sophisticated iPSC platforms in the industry. Evotec’s iPSC platform has been developed over the last years with the goal to industrialise iPSC-based drug screening in terms of throughput, reproducibility and robustness to reach the highest industrial standards, and to use iPSC-based cells in cell therapy approaches via the Company’s proprietary EVO cells platform.

About Sernova Corp and the Cell Pouch System cell therapy platform
Sernova Corp is developing regenerative medicine therapeutic technologies using a medical device and immune protected therapeutic cells (i.e., human donor cells, corrected human cells and stem-cell derived cells) to improve the treatment and quality of life of people with chronic metabolic diseases such as insulin- dependent diabetes, blood disorders including hemophilia, and other diseases treated through replacement of proteins or hormones missing or in short supply within the body.

The Cell Pouch, as part of the Cell Pouch System, is a proprietary, scalable, implantable macro- encapsulation device solution designed for the long-term survival and function of therapeutic cells. After implantation, the device incorporates with tissue, forming highly vascularised, native tissue chambers for the transplantation and function of therapeutic cells, that release proteins and hormones as required to treat disease.

The Cell Pouch, along with therapeutic cells, has been shown to provide long-term safety and efficacy in small and large animal models of diabetes and has been proven to provide a biologically compatible environment for insulin-producing cells in humans in a Canadian first-in-human study. Sernova is currently conducting a Phase I/II clinical trial study at the University of Chicago. Encouraging interim results have been presented at several international scientific conferences.

For more information, please visit www.sernova.com .

About Diabetes
Diabetes mellitus (“diabetes”) is a chronic incapacitating disease associated with severe lifelong conditions which require intensive monitoring and control, such as cardiovascular diseases, kidney diseases, nerve damage and eye diseases. At present, there is no cure for diabetes and only symptomatic treatment options are available. According to the International Diabetes Federation, it is estimated that 537 million people worldwide suffered from diabetes in 2021 (2019: 463 million) and this number is projected to reach 643 million by 2030. The disease is a major burden to the global healthcare systems with about $ 966 bn being spent on the treatment of diabetes in 2021 and it is projected that expenditure will reach $ 1.03 tn by 2030.

About Beta Cells
Beta cells play a key role in the pathogenesis of diabetes. Beta cells reside in clusters of hormone producing cells (“islets”) within the pancreas. They respond to elevated blood glucose levels (e.g. after a meal) by secreting the glucose lowering hormone insulin. In the type 1 form of diabetes (“T1D”), beta cells are destroyed by the patient’s own immune system. As a result, T1D patients must follow a life-long regimen of carefully dosed insulin injections. In patients with type 2 diabetes (“T2D”), beta cells are functionally impaired and yet have to work in the presence of metabolic stress and increased workload due to an impaired tissue insulin response. T2D is progressive, and current therapeutic options cannot prevent the deterioration of beta cell function, eventually also creating a need for insulin injections. Despite the fact that insulin treatments are important and widely used for people with diabetes, they cannot fully mimic the normal control of blood glucose levels by normal beta cells necessary to avoid acute and long-term complications of diabetes. There is a critical medical need for novel therapeutic options which can restore beta cell mass and, thereby, reduce or eliminate the need for insulin injections. Furthermore, beta cell replacement therapy also has the potential to prevent or reverse the decline in beta cell function in type 2 diabetes.

ABOUT EVOTEC SE
Evotec is a life science company with a unique business model that delivers on its mission to discover and develop highly effective therapeutics and make them available to the patients. The Company’s multimodality platform comprises a unique combination of innovative technologies, data and science for the discovery, development, and production of first-in-class and best-in-class pharmaceutical products. Evotec leverages this “Data-driven R&D Autobahn to Cures” for proprietary projects and within a network of partners including all Top 20 Pharma and over 800 biotechnology companies, academic institutions, as well as other healthcare stakeholders. Evotec has strategic activities in a broad range of currently underserved therapeutic areas, including e.g. neurology, oncology, as well as metabolic and infectious diseases. Within these areas of expertise, Evotec aims to create the world-leading co-owned pipeline for innovative therapeutics and has to-date established a portfolio of more than 200 proprietary and co-owned R&D projects from early discovery to clinical development. Evotec operates globally with more than 4,200 highly qualified people. The Company’s 15 sites offer highly synergistic technologies and services and operate as complementary clusters of excellence. For additional information please go to www.evotec.com and follow us on Twitter @Evotec and LinkedIn .

FORWARD-LOOKING STATEMENTS
This announcement contains forward-looking statements concerning future events, including the proposed offering and listing of Evotec’s securities. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “should,” “target,” “would” and variations of such words and similar expressions are intended to identify forward-looking statements. Such statements include comments regarding Evotec’s expectations for revenues, Group EBITDA and unpartnered R&D expenses. These forward-looking statements are based on the information available to, and the expectations and assumptions deemed reasonable by Evotec at the time these statements were made. No assurance can be given that such expectations will prove to have been correct. These statements involve known and unknown risks and are based upon a number of assumptions and estimates, which are inherently subject to significant uncertainties and contingencies, many of which are beyond the control of Evotec. Evotec expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Evotec’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.

Media Contact Evotec SE:
Gabriele Hansen, SVP Head of Global Corporate Communications & Marketing, Phone: +49.(0)40.56081-255, gabriele.hansen@evotec.com

IR Contact Evotec SE:
Volker Braun, SVP Head of Global Investor Relations & ESG, Phone: +49.(0)40.56081-775, volker.braun@evotec.com

SOURCE: Evotec AG

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