SVA:CC - Sernova Announces Additional Patient Insulin Independent and Cohort 2 Enrollment Complete in Ongoing Phase I/II Clinical Trial for Treatment of Type 1 Diabetes

(TheNewswire)

• To date Sernova reports 7 patientsin its Phase I/II type 1 diabetes clinical trial achieved freedom frominsulin injections and demonstrate blood sugar control in thenon- diabetic range (HbA1c 6.5%);

• 6 patients have reached between 5.5and 50 months of sustained insulin independence and freedom fromsevere hypoglycemic episodes;

• Completion of enrollment in Cohort2

LONDON, Ontario; BOSTON, Massachusetts – June 25,2024 – TheNewswire – Sernova Corp. (TSX:SVA)(OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage biotechnology company, today announces developments in its Phase I/IIclinical trial investigating a novel treatment for Type 1 Diabetes(T1D). To date a total of 7 patients across Cohorts 1 and 2 haveachieved insulin independence following transplants of human donorislets via Sernova’s proprietary Cell Pouch System™ and a marginalportal vein top up.  Additionally, the study, which is beingconducted at the University of Chicago, completed full enrollment ofthe second cohort of patients with the last patient being enrolledJune 24, 2024.

At baseline, all patients in the study were dependenton multiple daily insulin injections with average HbA1c levels (ameasure of glucose control over the prior 2 to 3 months) greater than6.5% across the study population.  In addition, prior to enrollmentin the study, patients had a history of severe hypoglycemic events (apotentially life-threatening drop in blood sugar leading to impairedcognition and consciousness) and undetectable plasma levels ofC-peptide (a marker of natural insulin production).  Insulinindependence in these first 7 patients has been accompanied by freedomfrom severe hypoglycemic events, sustained HbA1c levels in thenon-diabetic range (HbA1c <6.5%), and persistenttransplant-mediated insulin production measured by plasma C-peptide.

The trial, which focuses on Sernova’s Cell Pouchtechnology, demonstrates that insulinindependence and additional clinically meaningful patient outcomeswere achieved with lower than traditional islet masses infusedintra-portally, indicating an important contribution of the isletgrafts in Cell Pouch to the observed favorable blood glucose control. Sernova continues to be the first and onlycompany to announce positive patient outcomes in a clinical trial forT1D that combines donor islets transplanted via an implantabledelivery vehicle that also has full payload containment andretrievability capabilities should it be required, as evidenced by thefirst patient in Cohort 2. Interim data from this study indicates thatCell Pouch is generally safe and well tolerated and, when transplantedwith donor islets, contributes to the reversal of T1D, potentiallyminimizing the long-term comorbidities that include heart and kidneydisease, blindness and amputation. The Company anticipates announcingadditional trial results for the remaining 5 patients

in Cohort 2, later in the year.

Cynthia Pussinen, CEO of Sernova, expressed "we are excited withand encouraged by the impressive progress of our ongoing Phase I/IIclinical trial with donor islets and Cell Pouch. The ability toachieve sustained insulin independence, HbA1c levels in thenon-diabetic range and reductions in severe hypoglycemic events inpatients, using a retrievable payload device, signifies atransformative step forward in the treatment – and essentiallyfunctional cure - of Type 1 Diabetes. Sernova remains committed toadvancing the potential of our Cell Pouch technology to significantlyimprove the lives of patients and their families worldwide.”

Sernova Corp continues to collaborate closely with leading academic,pharmaceutical and clinical institutions to expand the scope andimpact of its technology. The company anticipates further advancementsas it progresses through additional cohorts and trials, with the goalof offering a scalable solution for insulin-dependent diabetes plusother chronic diseases.

About Sernova

Sernova Corp. is a clinical-stage biotechnology companythat is developing therapeutic cell technologies for chronic diseases,including insulin-dependent diabetes, thyroid disease, and blooddisorders that include hemophilia A. Sernova iscurrently focused on developing a ‘functional cure’ forinsulin-dependent diabetes with its lead technology, the Cell PouchSystem, a novel implantable and scalable medical device with immuneprotected therapeutic cells.

Sernova partnered with Evotec to develop an implantableoff-the-shelf iPSC (induced pluripotent stem cells) based isletreplacement therapy. This partnership provides Sernova a potentiallyunlimited supply of insulin-producing cells to treat millions ofpatients with insulin-dependent diabetes (type 1 and type 2).Sernova’s development pipeline that uses its Cell Pouch System alsoincludes: a cell therapy for hypothyroid disease resulting fromthyroid gland removal and an ex vivo lentiviral Factor VIII genetherapy for hemophilia A.

About Sernova’s Cell Pouch for usewith Cell Therapeutics

On implantation, The Cell Pouch forms a natural,vascularized tissue environment in the body allowing long-termsurvival and function of therapeutic cells that release essentialfactors that are absent or deficient in the bodies of patients withcertain chronic diseases. Sernova’s Cell Pouch System hasdemonstrated its potential to be a ‘functional cure’ for peoplewith T1D in an ongoing Phase 1/2 clinical study at the University ofChicago. The Cell Pouch technology integrateswith the body's natural biological processes, creating a biocompatibleenvironment for the delivery of therapeutic cells previously missingfrom the body including cells, hormones, blood factors and tissues.This innovative approach aims to provide a durable and sustainabletreatment option for Sernova’s lighthouse program to treatindividuals living with T1D, with additional future therapeuticprograms to follow for hypothyroidism and hemophilia A.

For further information, pleasecontact:

Christopher Barnes

VP, Investor Relations

Sernova Corp.

Tel: +1 519-902-7923

Email: christopher.barnes@sernova.com

Website: www.sernova.com

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.sedarplus.ca for additionalinformation on risks and uncertainties relating to the forward-looking statements. Sernova expressly disclaims anyintention or obligation to update or revise any forward-lookingstatements, whether as a result of new information, future events orotherwise.

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