SVA:CC - Sernova Provides Recap of 2023 Accomplishments and Anticipated 2024 Milestones

(TheNewswire)

• Recently completed recruitment of all 7 patients inCohort 2

• Anticipates additional data from Cohort 2 of Phase 1/2clinical trial evaluating its enhanced 10-channel Cell Pouch inpatients with type 1 diabetes (T1D) in Q1/24

• Expects to report preclinical data supporting an INDapplication to evaluate the use of therapeutic cells in combinationwith Cell Pouch in patients with post-operativehypothyroidism

LONDON, Ontario; Boston, Massachusetts – TheNewswire - January 29, 2024 – Sernova Corp. (TSX:SVA) (OTC:SEOVF)(FSE/XETRA:PSH), a clinical-stage company and leader in celltherapeutics, today provided a business update, including a recap of2023 accomplishments and a preview of certain milestones anticipatedin 2024.

“In 2023, we added to the compelling and expandingset of data demonstrating the safety and efficacy of our novel celltherapy platform for chronic diseases, including our higher capacity10-channel Cell Pouch that is being evaluated in our ongoing Phase 1/2human donor islet clinical trial in T1D,” said Cynthia Pussinen,Chief Executive Officer of Sernova. “We also made significantprogress with our hemophilia A program, including receipt of both Orphan Drug and Rare Pediatric Diseasedesignations from the U.S. Food and Drug Administration (FDA). Lastly, we announced an exciting preclinicalresearch collaboration with AstraZeneca that has the potential tosignificantly expand the use of the Cell Pouch in additionalhigh-value indications.”

“Looking ahead to 2024, we anticipate additionalpatient data from Cohort 2 of our T1D human donor islet trial, as wellas important data from our thyroid disease program as we work tofurther our preclinical pipeline. We continue to advance plans for ournext T1D Phase 1/2 clinical study utilizing Evotec’s iPSC-derivedislet like clusters (ILCs) in our Cell Pouch. Use of iPSCs providessignificant advantages over human donor islets, including the abilityto scale this promising treatment to commercially viable levelsenabling the treatment of millions of patients. Throughout 2024 ourstrategic partner, Evotec, will continue to optimize and advance thedevelopment of iPSC derived ILCs for use in additional IND enablingstudies and clinical trials. Given the complexity around scaling-up ofiPSCs and therapeutic cell manufacturing, as well as the relativenascency of the entire advanced therapeutics field, timelines haveextended, and we now anticipate initiating a clinical trial evaluatingour Cell Pouch with iPSC-derived ILCs in the fourth quarter of2025.” Ms. Pussinen added.

“I am encouraged with our progress and believe wehave built a solid foundation consisting of a portfolio offundamentally transformational medical treatments for patients livingwith chronic conditions that will result in multiple potentiallyvalue-creating milestones this year and next,” Ms. Pussinenconcluded.

2023 Achievements:

• Announced senior leadership additions, includingCynthia Pussinen as new Chief Executive Officer, and Dr. ModestusObochi, Ph.D., MBA, as Chief Business Officer

• Received both Orphan Drug Designation (ODD) and RarePediatric Disease Designation (RPDD) from the U.S. FDA for theCompany’s hemophilia A program

• Announced positive interim data from Cohorts 1 and 2 ofthe ongoing Phase 1/2 human donor islet clinical trial of its CellPouch System™ in patients with T1D at the 2023 IPITA-IXA-CTRMS JointCongress. Notably, five of the six patients in Cohort 1 were able todiscontinue insulin therapy following islet transplantation, and allsix patients achieved HbA1c values in the non-diabetic range 6.5%). In Cohort 2, the first six ofseven planned patients received the higher capacity 10-channel CellPouch and five patients received a first islet transplant. Stablefasting and stimulated serum C-peptide levels were observed followinga single islet transplant into the 10-channel Cell Pouch in the firstassessable Cohort 2 patient who subsequently achieved insulinindependence with a modest portal vein top-up.

• Announced positive results from its conformal coatingimmune protection technology program that is used in combination withthe Cell Pouch System™ and is intended to eliminate the need forchronic immunosuppression medications.

• Presented preclinical data supporting the planned Phase 1/2 clinicaltrial of Evotec’s “off-the-shelf” iPSC-derived ILCs incombination with Sernova’s Cell Pouch System for the treatment ofpatients with T1D. Specifically, data demonstrated that Evotec’siPSC-derived ILCs generated robust and durable insulin independencewith blood C-peptide levels and glucose tolerance test resultsequivalent to a test group with human islets. A separate study showedsustained normalization of blood sugar levels in diabetic micethroughout the 320-day term of the study. Human testing is anticipatedto begin in late 2025.

• Announced a research collaboration with AstraZeneca toevaluate the use of Sernova’s Cell Pouch System in combination withAstraZeneca’s novel therapeutic cells for various indications. Thediscovery work is being funded and conducted by AstraZeneca.

• Completed recruitment of all 7 patients in Cohort 2 ofthe ongoing Phase 1/2 trial using the 10-channel Cell Pouch.

Anticipated Select 2024Milestones:

• Additional data from Cohort 2 of the ongoing U.S. Phase1/2 clinical trial, which is evaluating its enhanced 10-channel Cell Pouch inpatients with T1D , are expected beginning inQ1.

• Additional preclinical data to support an INDapplication to evaluate the Company’s autograft thyroid cells inpatients suffering from thyroid disease, with no immunosuppressiveregimen required.

• Completion of thyroid disease market study validatingthe current market size and detailing the unmet medical need.

• Potential engagement with additional life sciencesfocused companies, academic institutions and external parties throughpartnership and collaboration opportunities, which could be announcedover the course of 2024.

• Additional funding to support growth through strategicalliances, credit facilities and/or institutional equity financingswith the goal of maximizing shareholder value.

Fiscal Year 2023 Financials

Today, Sernova filed its financial results on SEDAR forthe fiscal year 2023.

ABOUT SERNOVA CORP. AND THE CELLPOUCH SYSTEM PLATFORM FOR CELL THERAPY

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 is currently focused ondeveloping a ‘functional cure’ for insulin-dependent diabetes withits lead asset, the Cell Pouch System, a novel implantable andscalable medical device with immune protected therapeutic cells. Onimplantation, The Cell Pouch forms a natural vascularized tissueenvironment in the body for long-term survival and function oftherapeutic cells that release essential factors that are absent ordeficient in the bodies of patients with certain chronic diseases.Sernova’s Cell Pouch System has demonstrated its potential to be a‘functional cure’ for people with T1D in an ongoing Phase 1/2clinical study at the University of Chicago. Sernova is also advancinga proprietary technology in collaboration with the University of Miamito shield therapeutic cells from immune system attack with the goal toeliminate the need for chronic, systemic immunosuppression. In May2022, Sernova and Evotec entered into a global strategic partnershipto develop an implantable off-the-shelf iPSC (induced pluripotent stemcells) based islet replacement therapy. This partnership providesSernova a potentially unlimited supply of insulin-producing cells totreat millions of patients with insulin-dependent diabetes (type 1 andtype 2). Sernova continues to progress two additional developmentprograms that utilize its Cell Pouch System: a cell therapy forhypothyroid disease resulting from thyroid gland removal and an exvivo lentiviral Factor VIII gene therapy for hemophilia A.

FOR FURTHER INFORMATION, PLEASECONTACT:

Christopher Barnes

VP, Investor Relations

Sernova Corp.

christopher.barnes@sernova.com

Tel: 519-902-7923

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. Forward looking statements in this news release include,without limitation, statements relating to the timing of clinicaltrials, the timing with respect to the receipt of data from on-goingclinical trials, timing with respect to preclinical data, thecompletion of thyroid disease market study, statements with respect tothe potential future engagement with additional universities, lifesciences focus companies and external parties and the timing thereof.

These statements reflect the current expectations,assumptions and beliefs of management currently available to it on thedate such statements were made, including Sernova’s ability tosecure additional financing and licensing arrangements; the timingwith respect to the engineering and scaling-up of Sernova’stechnologies; the ability to conduct all required preclinical andclinical studies for the company’s Cell Pouch System and or relatedtechnologies; the timing and results of preclinical and clinicaltrials; the ability to obtain all necessary regulatory approvals on a timely basis; the ability to in-licenseadditional complementary technologies; and the ability of Sernova toexecute its business strategy, attract additional partners andsuccessfully compete in the market.

Although the Company believes that the assumptions inherent in theseforward-looking statements are reasonable, forward-looking statementsare not a guarantee of future performance and accordingly unduereliance should not be placed on such statements. Forward-lookingstatements are subject to a number of risks and uncertainties, somethat are similar to biotechnology companies and some that are uniqueto Sernova. The actual results may differ materially from thoseexpressed or implied by the forward-looking information, and even ifsuch actual results are realized or substantially realized, there canbe no assurance that they will have the expected consequences to, oreffects on, Sernova. Sernova’s annual information formdated January 29, 2024, its annual management's discussion andanalysis for the year ended October 31, 2023, and other documents itfiles from time to time with securities regulatory authoritiesdescribe the risks, uncertainties, material assumptions and otherfactors that could influence actual results and such factors areincorporated herein by reference. Copies of these documents areavailable without charge by referring to the company's profile onSEDAR+ at www.sedarplus.ca . Allforward-looking statements speak only as of the date on which theywere made and, except as may be required by applicable securitieslaws, the Company disclaims any intent or obligation to update anyforward-looking statements, whether as a result of new information,future events or results or otherwise.

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