SVA:CC - Sernova Provides Positive Clinical and Platform Portfolio Update

(TheNewswire)

• Type 1 diabetes (T1D)Cohort 2 patient data demonstrates favorableislet engraftment and long-term survival of human donor islets in theCell Pouch
• First treated Cohort 1 patient in the T1D clinical trial tocelebrate four years of insulin independence and normalizedHbA1c

• With recent positive findings in post-surgicalhypothyroidism large animal study, Sernova anticipates filing anInvestigational New Drug (IND) application in 2024

• Additional chronic disease indications identified forfurther pipeline expansion with a focus on endocrinedisorders

LONDON, Ontario; BOSTON, Massachusetts - TheNewswuire - April 2, 2024 –Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), aclinical-stage biotechnology company focused on the development ofregenerative medicine cell therapies for treatment of chronicdiseases, today provided a business update . Following a review of the company’stherapeutic pipeline and emerging opportunities for its Cell Pouchsystem platform technologies, Sernova confirms key prioritiesincluding its lighthouse program in insulin dependent Type 1 Diabetesplus its intention to advance an IND filing for its post-operativehypothyroidism program.

Data from a patient in Cohort 2 of the company’s leadclinical program for insulin dependentType 1 diabetes (T1D) confirms histologic evidence of long-term (oneyear) robust survival of abundant human donor islets throughout theCell Pouch.  Additional Cohort 2 findings are specific to an advancedimmunosuppression regimen planned for use in its upcoming Phase I/IItrial with stem cell-derived islets under co-development with Evotec.

Cohort 2 patients treated with anadvanced immunosuppression protocol avoided graft rejection and experienced minimal sideeffects in comparison to those patients observed in Cohort 1. None of the six patientsin Cohort 2 treated with the advanced regimen have tested positive fordonor specific antibodies (DSAs), a marker of graft rejection, incomparison to three of six patients who developed DSAs under theconventional immunosuppression regimen in Cohort 1 . Ancillary medication, used in some Cohort 2 patients, demonstrated highlyfavorable graft survival and function for islets transplanted to theCell Pouch and has been integrated into the updated regimen andimplemented for all subsequent patient trial enrollments. The company anticipates reportingadditional data from Cohort 2 of its ongoing Phase 1/2 clinical trialof its expanded 10-channel Cell Pouch during the second half of theyear at major medical conferences.

Sernova is pleased to report that this month marksthe four-year anniversary of the first patient in Cohort 1 of thisPhase 1/2 study who will celebrate insulin independence and normalizedblood sugar levels, based on two transplants of human donor islets tothe Cell Pouch plus a marginal portal vein top up.

“Based on the favorable results we are observing inongoing pre-clinical studies, we have concluded that ourhypothyroidism program represents another compelling opportunity bywhich to improve patients’ lives. We look forward to completing ourpre-clinical work, engaging with regulatory agencies, and preparingfor an IND filing later this year, with the goal of advancing a secondindication into the clinic, further demonstrating the Cell Pouch as adrug delivery vehicle platform technology. Also of note, in addition to allowingfor long term payload survival, our Cell Pouch has powerfulcontainment and retrievability capabilities that we expect will havetremendous value for pharmaceutical companies looking to treatpatients with cell therapies ,” said Cynthia Pussinen, Chief Executive Officer ofSernova.

“In parallel with these activities, and our ongoinghemophilia A work, we have identified several high value indicationswith unmet medical needs that could potentially benefit from ourplatform Cell Pouch technology, with an initial focus on endocrinedisorders. In the coming months, we will be conducting commercialassessments to prioritize those areas where we can best extend ourreach to more patients while creating enduring value for ourshareholders. I am excited for what we are poised to achieve this yearand look forward to providing further updates in the future,” Ms.Pussinen concluded.

ABOUT SERNOVA AND ITS CELL POUCHSYSTEM 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 technology, the Cell Pouch System, a novel implantable andscalable medical device with immune protected therapeutic cells.

On implantation, The Cell Pouch forms a naturalvascularized tissue environment in the body for long-term survival andfunction of therapeutic cells that release essential factors that areabsent or deficient in the bodies of patients with certain chronicdiseases. Sernova’s Cell Pouch System has demonstrated its potentialto be a ‘functional cure’ for people with T1D in an ongoing Phase1/2 clinical study at the University of Chicago.

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.

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 identifyforward-looking statements. These statements reflect management’sbeliefs with respect to future events and are based on informationcurrently available to management on the date such statements weremade. Many factors could cause Sernova’s actual results,performances or achievements to not be as anticipated, estimated orintended or to differ materially from those expressed or implied bythe forward-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-lookingstatements. Sernova expressly disclaims any intention or obligation toupdate or revise any forward-looking statements, whether as a resultof new information, future events or otherwise.

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