SEOVF - The Principal Investigator in Sernova's Type 1 Diabetes (T1D) Trial Confirms Patients with a History of Hypoglycemia Unawareness Are Now Insulin Independent

(TheNewswire)

LONDON, ONTARIO - TheNewswire - January 10, 2022– Sernova Corp. (TSXV:SVA) (OTC:SEOVF) (FSE/XETRA:PSH), aclinical-stage regenerative medicine and cell therapy therapeuticscompany developing a potential ‘functional cure’ for type 1diabetes (T1D) and other chronic diseases, is pleased to provide aprogress update on its Phase 1/2 T1D clinical trial in conjunctionwith Dr. Piotr Witkowski, the clinical trial’s PrincipalInvestigator at the University of Chicago. Dr. Witkowski wasoriginally scheduled to provide a clinical trial update at the 2022American Society of Transplant Surgeons (ASTS) Winter Symposium;however, the conference is now postponed until August 2022 as a resultof the ongoing COVID-19 pandemic.

The objective of Sernova’s Phase 1/2 clinical trial is to assess thesafety, tolerability and efficacy of its proprietary Cell Pouch™transplanted with insulin-producing islets in patients with T1Dcomplicated by hypoglycemia unawareness and a history of severehypoglycemic events. Study patients must meet stringent eligibilitycriteria including, but not limited to, long-standing T1D, recentepisodes of hypoglycemic unawareness and an absence ofglucose-stimulated C-peptide detectable in their bloodstream. Studypatients are eligible to receive up to three islet cell transplantsthroughout the study, including two marginal dose transplants into theCell Pouch and a single, marginal islet supplement transplanted viathe portal vein.

Sernova would like to highlight some updated study findings and keypoints from the ongoing trial:

• the ongoing safety and tolerability of Cell Pouch has been maintainedin all study patients;

• Islet transplantation to the Cell Pouch resulted in the establishmentof new, measurable islet function documented by detectable levels ofstimulated C-peptide in the first three patients, who completed theprotocol-defined course of transplants.

• a supplemental, single intraportal islet transplant was sufficient forthe first two patients to achieve and maintain sustained ongoinginsulin independence and freedom from severe hypoglycemic events forover 21 and 2 months, respectively.

• the third transplanted patient recently completed their course of CellPouch transplants and a supplemental intraportal islet infusion, with favorable improvements in glucose control, near-normallevels of C-peptide, an absence of severe hypoglycemic events andreductions in daily insulin use;

• the other three enrolled study patients are progressing through thestudy protocol, as planned. All have received Cell Pouch implants andare at various stages of protocol-defined islet transplants andfollow-up; and

• a 7 th study patient hasbeen identified.

“We are very encouraged by finding detectable serum C-peptide levelsafter islet transplantation into the Sernova Cell Pouch in the threemost advanced study patients. Additionally, we are very excited aboutthe first two patients becoming insulin independent and free fromsevere hypoglycemic events after a single supplemental intraportalislet infusion,” said Dr. Witkowski.  “I look forward tocontinuing this trial with Sernova as we further optimize our use ofthe Cell Pouch System and validate its therapeutic potential.”

Dr. Philip Toleikis, President & CEO of Sernova Corp furtherremarked, “We believe Sernova is the first company to report thatits first two transplanted T1D cell therapy study patients achievedsustained insulin independence.  We are further reassured that ourCell Pouch System is performing as expected by creating a safe,vascularized, and natural tissue environment inside the human body,allowing the islet cells to thrive and function efficiently followingtransplantation. As we progress through the trial, under the expertguidance of Dr. Witkowski, we have had several scientificbreakthroughs and advancements related to insulin producing celldynamics and efficacy related to our Cell Pouch technologies. Thesefindings have led to several technical optimizations, including theupcoming introduction of a higher capacity Cell Pouch configurationdesigned to accommodate the total quantity and distribution of isletsthat are achieving insulin independence for patients in our clinicaltrial.  This configuration of Cell Pouch has already receivedregulatory authorization to be used for the remaining trial implants.Sernova is grateful to Dr. Witkowski’s leadership in this trial aswe further enhance our therapeutic cell transplantation approach withour goal to achieve a ‘functional cure’ for the patients withcomplicated T1D.”

Sernova has developed its cell therapy platform, the Cell PouchSystem, with the vision of treating the millions of patients with T1Dand other chronic diseases using immune-protected therapeutic cells,including stem cell-derived technologies. Sernova’s approach is toprovide a minimally invasive, retrievable, safe, organ likeenvironment for rapid engraftment and long-term survival oftherapeutic cells as well as to avoid blood mediated inflammatoryreactions and permit cell retrievability that cannot be achieved withthe traditional portal vein transplantation.

For more information on this clinical trial, pleasevisit www.clinicaltrials.gov/ct2/show/NCT03513939 .

For more information on enrollment and recruitmentdetails please visit www.pwitkowski.org/sernova .

ABOUT HYPOGLYCEMIA UNAWARENESS

Hypoglycemia unawareness is a person’s inability to recognize thesymptoms of low blood sugar before they become severe or even fatal.It typically occurs when blood glucose levels are below 3.0 mmol/L andis estimated to affect approximately 15% of people with T1D.

Severe symptoms of low blood sugar include confusion, slurred speech,impaired motor coordination and personality changes. Individualsexperiencing a severe hypoglycemic event can lose their ability forself-care and self-control, requiring urgent intervention from anotherperson to prevent loss of consciousness, seizure, coma or death. After a person has had a first hypoglycemia unawareness episode,more are likely to occur.

ABOUT SERNOVA

Sernova is developing regenerative medicine therapeutic solutionsusing a medical  device (Cell Pouch) and immune protected therapeuticcells / tissues (i.e. human donor cells, corrected human cells andstem cell-derived cells) to improve the treatment and quality of lifeof people with chronic metabolic diseases such as insulin-dependentdiabetes, blood disorders including hemophilia, and other diseasestreated through cellular production of proteins or hormones missing orin short supply within the body. For more information, please visitwww.sernova.com.

ABOUT SERNOVA’S CELL POUCH SYSTEM CELL THERAPY PLATFORM

The Cell Pouch, as part of the Cell Pouch System, is a novel,proprietary, scalable, implantable macro- encapsulation devicesolution designed for the long-term survival and function oftherapeutic cells. After implantation, the device incorporates withtissue, forming highly vascularized, native tissue chambers for thetransplantation and function of therapeutic cells, that releaseproteins and hormones as required to treat disease.

The Cell Pouch, along with therapeutic cells, has been shown toprovide long-term safety and efficacy in small and large animal modelsof diabetes and has been proven to provide a biologically compatibleenvironment for insulin-producing cells in humans in a Canadianfirst-in-human study. Sernova is currently conducting a Phase 1/2clinical trial study at the University of Chicago. Positive initialresults have been presented at several international scientificconferences.

FOR FURTHER INFORMATION, PLEASE CONTACT:

Christopher Barnes

VP, Investor Relations

Sernova Corp.

christopher.barnes@sernova.com

Tel: 519-902-7923

www.sernova.com

Corey Davis, Ph.D.

LifeScience Advisors, LLC

cdavis@lifesciadvisors.com

Tel: 212-915-2577

FORWARD-LOOKING INFORMATION

This release contains statements that, to the extentthey are not recitations of historical facts, may constitute“forward-looking statements” that involve various risks,uncertainties, and assumptions, including, without limitation,statements regarding the prospects, plans, and objectives of thecompany. Wherever possible, but not always, words such as"expects", "plans", "anticipates","believes", "intends", "estimates","projects", "potential for" and similarexpressions, or that events or conditions "will","would", "may", "could" or"should" occur are used to identify forward-lookingstatements. These statements reflect management’s beliefs withrespect to future events and are based on information currentlyavailable to management on the date such statements were made. Manyfactors could cause Sernova’s actual results, performances orachievements to not be as anticipated, estimated or intended or todiffer materially from those expressed or implied by theforward-looking statements contained in this news release. Suchfactors could include, but are not limited to, the company’s abilityto secure additional financing and licensing arrangements onreasonable terms, or at all; ability to conduct all requiredpreclinical and clinical studies for the company’s Cell Pouch Systemand/or related technologies, including the timing and results of thosetrials; ability to obtain all necessary regulatory approvals, or on atimely basis; ability to in-license additional complementarytechnologies; ability to execute its business strategy andsuccessfully compete in the market; and the inherent risks associatedwith the development of biotechnology combination products generally.Many of the factors are beyond our control, including those caused by,related to, or impacted by the novel coronavirus pandemic. Investorsshould consult the company’s quarterly and annual filings availableon www.sedar.com for additional information on risks and uncertaintiesrelating to the forward-looking statements. Sernova expresslydisclaims any intention or obligation to update or revise anyforward-looking statements, whether as a result of new information,future events or otherwise.

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