Sernova to Acquire Cellular Local Immune Protection Technology Accelerating Expansion of its Regenerative Medicine Therapeutics Platform..
London, Ontario - TheNewswire - June 8, 2020 - Sernova Corp. (TSXV:SVA) (OTC:SEOVF)(FSE:PSH), a clinical-stage regenerative medicine therapeutics company, announced today its acquisition of an innovative cellular immune protection technology. This acquisition represents a strategic accelerator for expansion of Sernova's total regenerative medicine cell therapy therapeutics platform.
Said Dr. Philip Toleikis, President and CEO Sernova Corp., "This is a game-changer for Sernova. We have strategically focused on adding local immune protection technologies to our portfolio as they represent the last essential pillar for our cell therapy therapeutics platform. This technology acquisition, in addition to our recently announced collaboration with AgeX Therapeutics, Inc. to use their UniverCyte(TM) gene-editing technology to protect cells, positions Sernova with multiple potential approaches to guard therapeutic cells within our Cell Pouch against host immune-response across multiple clinical applications."
Pursuant to an asset purchase agreement with Converge Biotech, Inc. ("Converge"), Sernova is acquiring all intellectual property associated with Converge's conformal coating cell encapsulation technology ("Conformal Coating Technology"), including issued patents, patent applications, and know-how. The transaction is expected to close by June 11, 2020.
"Conformal coating technology could be very synergistic with the Sernova Cell Pouch, as it could confer protection from the immune attack, decreasing or eliminating the need for immunosuppressive drugs. The minimal volume of the conformal capsules makes it possible to include immuno-protected insulin-producing cells in the Sernova Cell Pouch. If the combination of these technologies proves successful, it will represent an important step towards elimination of the need for immunosuppressive medications, bringing a functional cure closer to reality for patients suffering from this debilitating disease," said Dr. Camillo Ricordi, Stacy Joy Goodman Professor of Surgery and Chief, Division of Cellular Transplantation, Distinguished Professor of Medicine, Professor of Biomedical Engineering, Microbiology and Immunology and Director, Diabetes Research Institute and Cell Transplant Center. The Diabetes Research Institute (DRI) is a designated Center of Excellence at the University of Miami Miller School of Medicine.
Why is the Conformal Coating Technology Important?
The Conformal Coating Technology consists of a thin proprietary coating layer that effectively cloaks coated therapeutic cells to protect them from an auto-response attack by one's own immune system post cell transplantation into the body.
The advantages and potential benefits of this cell encapsulating technology are as follows:
provides protection of the therapeutic cells from immune system attack locally within the Cell Pouch chambers potentially avoiding the need for life-long immunosuppression medications, that are typically required after cell transplantation;
enables close contact of the transplanted therapeutic cells with the vascularized tissue matrix within the Cell Pouch to enable closer interactions unlike standard microencapsulation technologies in which the capsules are significantly larger than the cells limiting required tissue interactions;
improves the diffusion of small molecules and biomolecules (i.e., glucose, insulin, and other proteins or hormones), providing a physiological glucose-stimulated insulin response without delay that occurs with other encapsulation technologies; and
due to the improved diffusion of biomolecules, it may require a smaller load of therapeutic cells to achieve the desired therapeutic effect in comparison to standard microcapsules.
Local immune protection technologies to cloak cells, such as the Conformal Coating Technology and the UniverCyte(TM) gene technology, have the potential to protect cells from immune system attack within Sernova's Cell Pouch through different and independent mechanisms.
"The potential to eliminate antirejection medications with these complementary technologies to our proprietary Cell Pouch, both for human donor and stem cell-derived cells, will enable us to increase patient safety and quality of life, and significantly expand the number of treatable patients suffering from chronic diseases. With extensive preclinical studies already conducted at DRI, we look forward to the possibility of advancing this local immune protection technology into human trials following successful preclinical proof-of-concept testing. We believe that this could accelerate Sernova's opportunity to be first-to-market to provide a functional cure to the many diabetic patients worldwide. Our vision is to bring a new standard of care approach for chronic debilitating diseases to the healthcare landscape," said Dr. Philip Toleikis.
To fund the Conformal Coating Technology acquisition, Sernova will issue to a strategic investor a $1,000,000 convertible debenture that is unsecured, repayable in 30 months (unless earlier converted or redeemed), and carries an 8% interest rate (the "Debenture"). The Company will also issue 3,000,000 non-transferable share purchase warrants (the "Warrants") to the strategic investor, each Warrant being exercisable into one common share at a price of $0.20 per share for 30 months. The Debenture holder will have the right to convert the principal amount of the Debenture into common shares of Sernova at a conversion price of $0.25 per share. "Securing the debenture financing commitment on these favorable terms when Sernova's Covid-19 impacted shares were trading in the range of $0.13-0.15 was strategic to reduce our cost of capital and minimize both dilution and any impact on existing cash resources," said David Swetlow, Sernova's CFO.
Neither the Debenture or Warrants have been or will be registered under the United States Securities Act of 1933, as amended (the "U.S. Securities Act"), or any state securities laws and such securities may therefore not be offered or sold in the United States or to or for the account or benefit of a person in the United States or a U.S. Person (as defined in Regulation S of the U.S. Securities Act) absent registration or an applicable exemption from the registration requirements of the U.S. Securities Act and applicable U.S. state securities laws. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the debenture units in any jurisdiction in which such offer, solicitation or sale would be unlawful.
ABOUT SERNOVA'S CELL POUCH SYSTEM
The Cell Pouch, as part of the Cell Pouch System, is a novel, proprietary, scalable, implantable macro- encapsulation device solution designed for the long-term survival and function of therapeutic cells. The device upon implantation is designed to incorporate with tissue, forming highly vascularized tissue chambers for the transplantation and function of therapeutic cells, which then 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.
ABOUT SERNOVA CORP.
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. For more information, please visit www.sernova.com
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This news release contains forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects", "potential" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should" occur, and include statements about the closing of the Conformal Coating Technology acquisition and the Debenture issuance and funding. Although Sernova believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance, and actual results may differ materially from those in forward-looking statements. While Sernova considers these assumptions to be reasonable, these assumptions are inherently subject to significant scientific, business, economic, competitive, market and social uncertainties and contingencies. Additionally, there are known and unknown risk factors that could cause Sernova's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements contained in this press release.
Forward-looking statements are based on the beliefs, estimates, and opinions of Sernova's management on the date such statements were made, which include our beliefs about the effect on company operations and capital markets of events related to the COVID-19 pandemic, the conduct and outcome of discussions with strategic partners, and expected progress in preclinical programs and clinical trials. Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
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