2025 Corporate Review

(TheNewswire)

VANCOUVER, BC, December 31st. 2025 / - TheNewswire - BioVaxys Technology Corp. (CSE:BIOV) (OTCQB: BVAXF) (FRA: 5LB) ("BioVaxys" or the"Company") is pleased to provide a summary of operatinginitiatives over the past year following the integration of the DPX™platform into the BioVaxys business.  

The Company's focus continues to drive organic growth by:

• Expanding its early-stage pipeline by pursuing multiple out licensingopportunities and research collaborations where the Company's DPXplatform can address specific needs  

• Reducing internal risk & the considerable funding requirements oflate-stage clinical studies by out-licensing maveropepimut-S (MVP-S)in selected indications seeking a co-development partner forDPX-formulations in infectious diseases. 

• Re-engagement of clinical trial investigators for continuations ofphase 1 studies of DPX formulations  

The Company's DPX platform is a major innovation in vaccinedevelopment that offers a solution to limitations faced by vaccinesusing other antigen delivery methods. The DPX platform delivers activeingredients to the immune system using a novel mechanism of actionthat does not release active ingredients at the site of the injection,but rather forces an active uptake of immune cells and delivery intothe lymphatic nodes. The programming of immune cells happens in vivoand offers a more efficient approach that mimics the natural functionof the immune system. This "no release" mechanism allows foran active uptake of antigens into immune cells and lymph nodes for asustained activation of the immune system in which the T cell flow issustained over a longer duration than traditional vaccines on themarket.

Enhanced Scientific and BusinessDevelopment Expertise

In 2025, BioVaxys made significant enhancements to its scientific andbusiness development expertise through the addition of Dr. JamesTartaglia to the Company’s Board of Directors, and Dr MarianneStanford as Scientific Advisor.  

Dr. Tartaglia is an internationally recognized vaccine R&D leaderwith over 34 years of industry experience, including contributions topartnerships with private sector, government and internationalagencies.  Dr. Tartaglia recently retired as Global Head of VaccineDevelopment and Life Cycle Management for Sanofi.  During histwenty-seven years at Sanofi, Dr. Tartaglia was responsible for avaccine portfolio of 25 projects extending from phase I/II throughlife cycle management in the areas of influenza, pediatric combinationvaccines, RSV, rabies, Yellow Fever, pneumococcal and meningococcalvaccines. Over his career, Dr. Tartaglia has been involved in thelicensure of 20 vaccines in veterinary and human health. Prior toSanofi, he was Executive Director of Research at VirogeneticsCorporation, a former subsidiary of Sanofi Pasteur. At Virogenetics hehelped develop the poxvirus vector technology as an immunizationvehicle for both veterinary and human application, including HIV andcancer.  He is an inventor on over 20 patents relating to recombinantvaccines and has authored over 130 publications in the areas ofmolecular virology and recombinant vaccine technology and participatesas associate editor and/or reviewer for several peer-reviewedjournals.

Dr Stanford was Vice President of R&D at the former IMV Inc, whereshe and her team were responsible for the development of the DPX™vaccine portfolio. This included the study of the unique mechanism ofaction of the DPX platform and its safety, efficacy, and dosingschedules in preclinical models. Under her leadership, Dr.Stanford’s team also demonstrated that combining DPX,cyclophosphamide and then PD-1 blockade (using antibodies such aspembrolizumab, Merck’s Keytruda™) enhanced immunogenicity and thusefficacy in cancer models.  Dr. Stanford and collaborators havepublished numerous studies and she is named inventor on multiplepatents related to the DPX platform and DPX formulations. Thisincludes patents that explore DPX compositions that express mRNAencoded by the nucleic acid components in targeted cells.

With new doors opening from its Scientific Advisors and Board,BioVaxys has been engaging in outreach efforts with major vaccine andpharma companies to introduce the DPX platform and explore researchcollaborations in the infectious disease field for its RSV and fluvaccine programs, as well as for new DPX-based formulations in cancerand viral diseases.

Clinical Studies

Phase 1 Study of MVP-S in HR+ / HER2-Stage II-III breast cancer

Earlier this month, BioVaxys announced positive results from a phase 1clinical study of maveropepimut-S ("MVP-S") along withneoadjuvant hormone therapy in women with hormone receptor positiveHER2 negative (HR+HER2-) stage II-III breast cancer.  

The global market for HER2-negative breast cancer was valued at $14.4billion in 2024 and is projected to reach $21.5 billion by 2030.HR+/HER2- tumors represent the largest subgroup within this market,accounting for an estimated 57.77% of the total revenue share in2024.1

The clinical study demonstrated that BioVaxys' MVP-S incombination with letrozole (a commonly used neoadjuvant hormonetherapy for treating some types of breast cancer by decreasing theamount of estrogen hormone your body makes) generated a strong immuneresponse in study participants with positive HER2 negative (HR+HER2-)stage II-III breast cancer.  Patients in the study had at least a 50%decrease in Ki67 levels from median 24% before treatment to median 6%after treatment. Ki-67 is a protein marker used in breast cancer tomeasure the proliferation or growth rate of cancer cells, withelevated levels typically indicating a more aggressive tumor. Onepatient had an 8-fold increase of survivin-specific circulatingInterferon-gamma (IFN-?) T cells, which is a critical messengermolecule produced by T cells that promotes an effective cell-mediatedimmune response against cancer by activating immune cells.

BioVaxys and the investigating team at Providence Cancer Center inOregon now plan to further evaluate the systemic immunity of MVP-S andconduct expanded profiling of biopsy compared to post-treatmentsurgical samples, using the additional data to pursue a phase II studywith MVP-S to modify the tumor immune environment in high-risk HR+breast cancer.

Collaborations and Licensing

BioVaxys/Sona Nanotech

In May 2025, the Company and Sona Nanotech Inc. ("Sona")jointly announced that they entered into a research agreement tocollaborate on the development of new cancer therapeutics based on theCompany's DPX Immune Educating Platform in combination withSona's Targeted Hyperthermia Therapy™ (“THT”), aphotothermal cancer therapy that uses highly targeted infrared lightand intra-tumoral gold nanorods to treat solid tumors. Thecollaboration will evaluate the immune stimulatory properties of DPX(without an antigen cargo) administered together with THT, as acharacteristic of DPX is that it helps prime the innate immune systemwhich in turn can activate and strengthen the adaptive immuneresponse. The collaboration will also evaluate the combination use ofTHT together with a DPX formulation as a carrier for novel neoantigensexpressed on the surface of tumor cells following immunotherapy, suchas with THT. Neoantigens are unique proteins that are not present inhealthy tissues that arise from changes in cancer cells and play acrucial role in stimulating anti-tumor immune response. Immunotherapysuch as THT can trigger these tumor cell changes and the expression ofneoantigens, so packaging a tumor neoantigen in DPX for presentationto the immune system is anticipated to accelerate THT's efficacy.The research studies based on the BioVaxys and Sona technologies willbe conducted at Dalhousie University, Halifax, Nova Scotia, under thedirection of Sona's CMO, Carman Giacomantonio, MD MSc FRCSC,Division of General and Gastrointestinal Surgery, Department ofPathology, Dalhousie University, and Barry Kennedy, PhD, of theGiacomantonio Immuno-Oncology Research Group at Dalhousie University.

Maveropepimut-S (MVP-S)

To reduce internal risk and the considerable funding requirements oflate-stage clinical studies, BioVaxys has been exploring out-licensingmaveropepimut-S (MVP-S) in selected indications.  In addition toprevious licensing discussions this year, the Company has been indiscussions with a global pharma company interested in licensingmaveropepimut-S (MVP-S) for ovarian cancer.  Although in early stagesof a transaction, this potential licensee sees MVP-S as an excellentfit for expanding its footprint in oncology.  BioVaxys President andChief Operating Officer Kenneth Kovan stated "The clinical datafrom MVP-S is very compelling and we think the vaccine can become avaluable tool in cancer immunotherapy. The significant investment forinternal development of a later-stage program is such that it makesmore sense for remaining clinical studies with MVP-S to be pursued bya company with the appropriate resources, as this potential partnercertainly does.”

DPX+mRNA Formulations

The Company and a prospective partner in the animal health field haveagreed to advance a research collaboration for a proof-of-productprogram to evaluate a DPX formulation of a proprietary mRNA sequencefor diseases requiring long-duration protection such as rabies.  Theresearch agreement governing the collaboration is expected to befinalized and announced early 2026.

Data from proof-of-concept studies of DPX-mRNA formulations conductedin collaboration with leading RNA technology company Etherna and PCIBiotech demonstrate that DPX provides enhanced in vitro and in vivostability of packaged mRNA, attracts a therapeutically unique subsetof Antigen Presenting Cells (APCs) to the injection site for targeteduptake of mRNA by the immune system, and that immunization with DPXcontaining mRNA induces specific immune responses towards encodedantigens.  BioVaxys has several issued patents related to DPX-mRNAformulations.

Kovan says "The DPX platform is ideal for mRNA delivery, as itremains localized and does not spill out from the injection site andhas superior stability than LNPs.  We are looking forward to thiscollaboration as it will advance our current proof-of-concept data forDPX+mRNA formulations and provide us with proof-of-product, give usanother pipeline asset, and lay the foundation to explore other mRNAformulations.”

DPX-RSV

The Company is seeking a partner for further clinical development ofits DPX-RSV for Respiratory Syncytial Virus (“RSV”), whichsuccessfully completed a phase 1 human study for safety and efficacy.DPX-RSV demonstrated antigen-specific immune responses in 93% ofsubjects, with 100% of responders in a 25?g single-dose cohortmaintaining antigen-specific immunity one year post vaccination.Currently available RSV vaccines including GSK's Arexvy,Moderna's mResvia, and Pfizer's Abrysvo target either the For G proteins of the virus and provide protection by neutralizing theRSV virus. Clinical measures of efficacy focus on the amount ofneutralizing antibodies in the bloodstream. DPX-RSV works differently,as it targets the SH viral ectodomain of the RSV virus and, instead ofneutralizing the virus, it enables the immune system to recognize anddestroy RSV-infected cells.  

Additional infectious disease programs in the BioVaxys portfolio thatare potential out-license candidates include DPX-rHA/DPX-FLU, aninfluenza vaccine candidate of recombinant hemagglutinin (wholeprotein ~300 amino acids) / whole heat killed virus package in DPX,and DPX-rPA, an and an anthrax vaccine consisting of DPX+ recombinantanthrax protective antigen. Animal challenge studies performed withlethal anthrax respiratory exposure levels with our DPX-based anthraxvaccine demonstrated 100% immunity following a single injectioncompared to current vaccines which require more than one dose.

Kovan stated "With input from Dr. Tartaglia, we have beenaggressively conducting targeted outreach to major vaccine companiesand international vaccine initiatives to introduce the DPX platformand share its capabilities, with several discussions alreadyongoing.”

Licensees: SpayVac for Wildlife, Inc.and Zoetis, Inc.

The Company has revenue generating licenses with Zoetis Inc. andSpayVac-for-Wildlife, Inc. for vaccines in the animal health fieldbased on the Company's lipid encapsulation technology, with bothlicensors making excellent progress towards commercialization.

SpayVac for Wildlife, Inc., initiated the submission process to secureregulatory approval for SpayVac™, a pZP immunocontraceptive vaccinetargeting feral horses and free-ranging deer populations. At the coreof SpayVac is a patented technology for a liposome-based deliveryplatform designed to create long-lasting, targeted immune responsesthat is licensed from BioVaxys Technology Corp.  

SpayVac for Wildlife, Inc also announced this fall that results from acollaborative research project conducted in the Bavarian ForestNational Park in Germany have recently been published in the EuropeanJournal of Wildlife Research.  A single-dose of SpayVac significantlyreduced fertility to 11% in vaccinated deer compared to a fertilityrate of 86% in control animals.

Ongoing research with other antigens is targeting commercialaquaculture, companion animals, and other applications. In April 2025,the Company announced the expansion of the Fields of Use in thecurrent License Agreement with SpayVac to include commercialaquaculture, plus the farm-raised fish market, which will furtherincrease BioVaxys' royalty revenue.

Zoetis is preparing for regulatory submission for a pZPimmunocontraception vaccine based on the Company's lipidencapsulation technology for cattle in Australia and Brazil.

James Passin, CEO, stated, “In 2025, we have continued to build aworld-class team of advisors and directors to help the Company developand monetize its extraordinarily undervalued DPX IP portfolio. We lookforward to advancing and crystallizing ongoing out-licensing andresearch collaboration discussions in 2026, a year in which weanticipate aggressive business development activity and booking ourfirst royalty income.”  

1. Ellis, M. J., Suman, V. J., Hoog, J., Lin, L., Snider, J., Prat, A.,Parker, J. S., Luo, J., DeSchryver, K., Allred, D. C., Esserman, L.J., Unzeitig, G. W., Margenthaler, J., Babiera, G. V., Marcom, P. K.,Guenther, J. M., Watson, M. A., Leitch, M., Hunt, K., et al.Randomized phase II neoadjuvant comparison between letrozole,anastrozole, and exemestane for postmenopausal women with estrogenreceptor-rich stage 2 to 3 breast cancer: Clinical and biomarkeroutcomes and predictive value of the baseline PAM50-based int. J.Clin. Oncol. 29: 2342-2349, 2011. 

About BioVaxys TechnologyCorp.

BioVaxys Technology Corp. (www.biovaxys.com), a biopharmaceuticalscompany registered in British Columbia, Canada, is a clinical-stagebiopharmaceutical company dedicated to improving patient lives withnovel immunotherapies based on the DPX™ immune-educating technologyplatform and it's HapTenix© tumor cell construct platform, fortreating cancers, infectious disease, antigen desensitization for foodallergy, and other immunological diseases. Through a differentiatedmechanism of action, the DPX™ platform delivers instruction to theimmune system to generate a specific, robust, and persistent immuneresponse. The Company's clinical stage pipeline includesmaveropepimut-S (MVP-S), based on the DPX™ platform, in phase IIBclinical development for advanced Relapsed-Refractory Diffuse Large BCell Lymphoma (DLBCL) and platinum resistant Ovarian Cancer. MVP-Sdelivers antigenic peptides from the survivin family, a set ofwell-recognized cancer antigens commonly overexpressed in advancedcancers, and also delivers an innate immune activator and a universalCD4 T cell helper peptide. MVP-S has been well tolerated and hasdemonstrated defined clinical benefit in multiple cancer indicationsas well as the activation of a targeted and sustained,survivin-specific anti-tumor immune response. BioVaxys is alsodeveloping DPX™+SurMAGE, a dual-targeted immunotherapy combiningantigenic peptides for both the survivin and MAGE-A9 cancer proteinsto elicit immune responses to these two distinct cancer antigenssimultaneously, DPX™-RSV for Respiratory Syncytial Virus, DPX+rPAfor peanut allergy prophylaxis, and BVX-0918, a personalizedimmunotherapeutic vaccine using its proprietary HapTenix©'neoantigen' tumor cell construct platform for refractivelate-stage ovarian cancer.

BioVaxys common shares are listed on the CSE under the stock symbol"BIOV" and trade on the Frankfurt Bourse (FSE: 5LB) and inthe U.S. on the OTC Markets (OTCQB: BVAXF). For more information,visit www.biovaxys.com and connect with us on X and LinkedIn.

ON BEHALF OF THE BIOVAXYSBOARD

Signed "James Passin" / James Passin, Chief ExecutiveOfficer

Office Phone: +1 740 358 0555

Cautionary Statements onForward-Looking Information

This news release includes certain"forward-looking information" and "forward-lookingstatements" (collectively "forward-looking statements")within the meaning of applicable securities legislation. Allstatements, other than statements of historical fact, included herein,without limitation, statements relating to the future operating orfinancial performance of the Company, are forward-looking statements.Forward-looking statements are frequently, but not always, identifiedby words such as "expects", "anticipates","believes", "intends", "estimates","potential", "possible", and similar expressions,or statements that events, conditions, or results "will","may", "could", or "should" occur or beachieved. There can be no assurance that such statements will prove tobe accurate, and actual results and future events could differmaterially from those expressed or implied in such forward-lookingstatements.

Forward-looking statements reflectthe beliefs, opinions and projections on the date the statements aremade and are based upon a number of assumptions and estimates,primarily the assumption that BioVaxys will be successful indeveloping and testing vaccines, that, while considered reasonable byBioVaxys, are inherently subject to significant business, economic,competitive, political and social uncertainties and contingenciesincluding, primarily but without limitation, the risk thatBioVaxys' vaccines will not prove to be effective and/ or willnot receive the required regulatory approvals. With regards toBioVaxys' business, there are a number of risks that could affectthe development of its biotechnology products, including, withoutlimitation, the need for additional capital to fund clinical trials,its lack of operating history, uncertainty about whether its productswill complete the long, complex and expensive clinical trial andregulatory approval process for approval of new drugs necessary formarketing approval, uncertainty about whether its DPX platform can bedeveloped to produce safe and effective products and, if so, whetherits vaccine products will be commercially accepted and profitable, theexpenses, delays and uncertainties and complications typicallyencountered by development stage biopharmaceutical businesses,financial and development obligations under license arrangements inorder to protect its rights to its products and technologies,obtaining and protecting new intellectual property rights and avoidinginfringement to third parties and their dependence on manufacturing bythird parties.

Many factors, both known andunknown, could cause actual results, performance or achievements to bematerially different from the results, performance or achievementsthat are or may be expressed or implied by such forward-lookingstatements and the parties have made assumptions and estimates basedon or related to many of these factors. BioVaxys does not assume anyobligation to update the forward-looking statements of beliefs,opinions, projections, or other factors, should they change, except asrequired by applicable securities laws.

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