Viatris Announces Launch of First Clozapine Orally Disintegrating Tablet (ODT) in Canada Français
ETOBICOKE, ON, May 27, 2025 /CNW/ -- Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced the launch in Canada of Gen-Clozapine orally disintegrating tablets (ODT) (12.5 mg, 25 mg, 50 mg, 100 mg and 200 mg), providing a new treatment option for treatment-resistant schizophrenia patients. This marks the first availability in Canada of an orally disintegrating tablet of clozapine, which is the only approved antipsychotic for treatment-resistant schizophrenia 1. It is estimated that 25% to 30% of individuals with schizophrenia meet the criteria for treatment-resistant schizophrenia. 1
Dr. Ofer Agid, Medical Head of Ambulatory Services in the Schizophrenia Division at the Centre for Addiction and Mental Health (CAMH) in Toronto, commented, "The introduction of Gen-Clozapine is welcome news for patients and physicians alike as this new clozapine formulation rapidly disintegrates when placed on the tongue or can be chewed, which provides a new option for some patients who may need it. This also gives physicians an alternative to the current tablet dosage form."
Gen-Clozapine has been available in tablet form (not orally disintegrating) since 2003. Viatris has provided access to this medicine, and related care, to thousands of Canadian patients through the Gen-Clozapine Access Network (GenCAN) for over 18 years.
Viatris Canada's Country Manager Jeffrey Long commented, "The launch of Gen-Clozapine orally disintegrating tablets demonstrates further evidence of our commitment to providing diversified treatment options to patients and healthcare professionals in Canada. Viatris' strong heritage in mental health, and experience with clozapine specifically, puts us in an excellent position to provide access to this new formulation which will impact patient treatment."
Gen-Clozapine orally disintegrating tablets are available by prescription only and through the GenCAN patient support program. Through GenCAN, Viatris is committed to patient safety, continued advancement of clinical knowledge and applying technology solutions to simplify monitoring practices. The program supports more than 12,000 active patients across Canada, collaborating with healthcare teams for the safe and effective use of Gen-Clozapine.
For more information, please consult the Product Monograph at https://pdf.hres.ca/dpd_pm/00078407.PDF.
Remington G, Addington D, Honer W, Ismail Z, Raedler T, Teehan M (September 2017). "Guidelines for the Pharmacotherapy of Schizophrenia in Adults". Canadian Journal of Psychiatry. Revue Canadienne de Psychiatrie. 62 (9): 604–616.
About Viatris
Viatris Inc. (NASDAQ: VTRS) is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases. With our exceptionally extensive and diverse portfolio of medicines, a one-of-a-kind global supply chain designed to reach more people when and where they need them, and the scientific expertise to address some of the world's most enduring health challenges, access takes on deep meaning at Viatris. We are headquartered in the U.S., with global centers in Pittsburgh, Shanghai and Hyderabad, India. Learn more at viatris.com and investor.viatris.com, and connect with us on LinkedIn, Instagram, YouTube and X (formerly Twitter).
Forward-Looking Statements
This statement includes statements that constitute "forward-looking statements." These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements may include statements regarding new product launches. Because forward-looking statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: actions and decisions of healthcare and pharmaceutical regulators; our ability to comply with applicable laws and regulations; changes in healthcare and pharmaceutical laws and regulations in the U.S. and abroad; any regulatory, legal or other impediments to Viatris' ability to bring new products to market; Viatris' or its partners' ability to develop, manufacture, and commercialize products; the scope, timing and outcome of any ongoing legal proceedings, and the impact of any such proceedings; Viatris' failure to achieve expected or targeted future financial and operating performance and results; risks associated with international operations; changes in third-party relationships; the effect of any changes in Viatris' or its partners' customer and supplier relationships and customer purchasing patterns; the impacts of competition; changes in the economic and financial conditions of Viatris or its partners; uncertainties and matters beyond the control of management, including general economic conditions, tariffs and trade restrictions, inflation and exchange rates; and the other risks described in Viatris' filings with the Securities and Exchange Commission (SEC). Viatris routinely uses its website as a means of disclosing material information to the public in a broad, non-exclusionary manner for purposes of the SEC's Regulation Fair Disclosure (Reg FD). Viatris undertakes no obligation to update these statements for revisions or changes after the date of this press release other than as required by law.
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Montreal Gazette
3 hours ago
- Montreal Gazette
Letters: Silencing doctors sends a chill
Letters To The Editor I am appalled that the Collège des médecins is telling its members not to communicate with patients about proposed legislation that could change how doctors are paid. What right does the Collège have to do this? It must be taking its cues from the government. That's a problem, especially when the political climate south of the border chips away at the right to say anything that disagrees with the government's line. Meanwhile, doctors are saying they are working under too many levels of management in a health system that is broken and toxic. Who among us would like to be in their place? Negotiating should be about arriving at a compromise. But it seems the government knows what it wants and has the power to ultimately get it. It just doesn't have to suffer with the result. That's left to the rest of us. Rod Elkin, Pierrefonds The cheers we hear for Canada's team All across the country we can hear Canadians shouting in unison: 'Go Oilers Go!' Even in Quebec, people are adding their voices to the chorus — though some presumably with shouts of: 'Allez Pétroliers Allez!' Robert Fox, Dorval Ghazal should honour her oath Québec solidaire co-spokesperson Ruba Ghazal declares Canada to be 'a bizarre country' because we invited 'the monarch of a foreign country' to read the throne speech. Whatever else King Charles III may be, he is the constitutional monarch of Canada. Ghazal, like me, is a naturalized Canadian. I assume she had to pass a citizenship test and swear her allegiance and duty to the constitutional monarch — not as a feudal overlord but as a symbol of our sovereign Constitution. Political leaders should know the Constitution and honour their oaths. Elaine Bander, Montreal Student's plea a poignant reminder Re: ' Dear Miss Teacher, Why can't I fail too? ' (Opinion, May 31) What an absolutely true and heart-rending appeal to teachers by Maïka Forget. A poignant reminder that grades should not be the only things that make an individual a good student. As a retired teacher, I was always guided by a strong underlying belief in the capacity of each young life I was privileged to have in my classroom. I salute Forget's determination that, despite the performance assessment of our educational system, she is committed to 'make the world a better place.' It is my most profound belief that she will. Vivianne M. Silver, Côte-St-Luc Submitting a letter to the editor Letters should be sent by email to letters@ We prioritize letters that respond to, or are inspired by, articles published by The Gazette. If you are responding to a specific article, let us know which one. Letters should be sent uniquely to us. The shorter they are — ideally, fewer than 200 words — the greater the chance of publication. Timing, clarity, factual accuracy and tone are all important, as is whether the writer has something new to add to the conversation. We reserve the right to edit and condense all letters. Care is taken to preserve the core of the writer's argument. Our policy is not to publish anonymous letters, those with pseudonyms or 'open letters' addressed to third parties. Letters are published with the author's full name and city or neighbourhood/borough of residence. Include a phone number and address to help verify identity; these will not be published. We will not indicate to you whether your letter will be published. If it has not been published within 10 days or so, it is not likely to be.
Winnipeg Free Press
3 hours ago
- Winnipeg Free Press
Immersive film at Manitoba Museum allows humans to hear like orcas
Manitoba Museum's latest exhibition invites visitors to dive deep into the waters of the Salish Sea and immerse themselves in the world of the endangered southern resident killer whales. The augmented-reality experience Critical Distance is a 15-minute animated film that launches its Canadian tour in Winnipeg for Ocean Week 2025, and will be showing at the Science Gallery until Aug. 31. The film, on tour with Nature Canada in association with the Alliance of Natural History Museums of Canada, makes a strong case for ocean conservation, says Scott Mullenix from Nature Canada. MIKE DEAL / FREE PRESS A group of participants watch Critical Distance via AR goggles at the Manitoba Museum. MIKE DEAL / FREE PRESS A group of participants watch Critical Distance via AR goggles at the Manitoba Museum. 'Some people get pretty emotional going through the experience. We want to take that emotion and engagement and turn it into something useful for the orca pod and the ocean that Nature Canada is trying to protect. We thought a great way to do that would be to have visitors understand the different roles they can play,' he says. MIKE DEAL / FREE PRESS Adam May is co-creator of Critical Distance. MIKE DEAL / FREE PRESS Adam May is co-creator of Critical Distance. The immersive short focuses on the J Pod, one of three pods in the acoustic clan who are residents of the waters. The audience follows eight-year-old orca Kiki and her family as they navigate the challenges thrown up by human activity. Sound is vital to the orca whales, who use echolocation to communicate, and sound pollution is threatening the pod's ability to hunt, bond and navigate. The term 'critical distance' refers to the point in space where direct sound, such as an orca's call, is equal in intensity to reverberant or background noise. Placed in the middle of the pod, viewers hear and see the clicks, whistles and calls the members of the pod use to communicate with each other. These vocalizations are typically effective across long distances in a natural ocean environment, but the orcas, who live beneath a busy shipping area, struggle to make themselves heard. 'Some people get pretty emotional going through the experience. We want to take that emotion and engagement and turn it into something useful.'–Scott Mullenix Human activity, especially from boats, ships and underwater construction, has introduced significant noise pollution into marine habitats. This background noise effectively reduces the critical distance, which means orcas have to be much closer to each other before their calls are distinguishable from the surrounding noise. Submerged underwater with Kiki, the contrast in the varying sounds different vessels make become obvious – paddle boats barely make a splash, but motorboats and trawlers jar the quiet, littering the water with their loud vibrations. Sounds are translated into visuals so the audience can see what the orcas hear; it's a simple but effective method to experience the world from an entirely different perspective. After the AR animation, visitors are invited to join the movement to protect Canada's ocean by connecting directly with ocean conservation experts through Nature Canada's Ask the Experts section. MIKE DEAL / FREE PRESS Critical Distance participants are fully immersed in the orca's experience. MIKE DEAL / FREE PRESS Critical Distance participants are fully immersed in the orca's experience. Visitors can ask whatever they want about orcas, threats to the Salish Sea or the ocean in general. Their questions will be sent to experts who include Adam Olsen, lead negotiator and member of Tsartlip First Nation; Julia Laforge, protected areas policy manager at Nature Canada; and Rebecca Brushett, marine planning and engagement co-ordinator at Ecology Action Centre, who will reply with answers. The hope is that the experience will encourage people to lobby for change to protect one of the country's most endangered marine mammals — at last count, there were fewer than 80 southern resident killer whales in the Salish Sea. AV KitchingReporter AV Kitching is an arts and life writer at the Free Press. She has been a journalist for more than two decades and has worked across three continents writing about people, travel, food, and fashion. Read more about AV. Every piece of reporting AV produces is reviewed by an editing team before it is posted online or published in print — part of the Free Press's tradition, since 1872, of producing reliable independent journalism. Read more about Free Press's history and mandate, and learn how our newsroom operates. Our newsroom depends on a growing audience of readers to power our journalism. If you are not a paid reader, please consider becoming a subscriber. Our newsroom depends on its audience of readers to power our journalism. Thank you for your support.
Cision Canada
3 hours ago
- Cision Canada
BioVaxys Issues Corporate Update
VANCOUVER, BC, June 3, 2025 /CNW/ -- BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) ("BioVaxys" or the "Company") is pleased to provide a summary of current operating initiatives including the integration and disposition of assets acquired in February 2024 from the former IMV, Inc., the non-exclusive out-licensing of DPX to human and animal health companies, restarting clinical studies---notably DPX-surMAGE in advanced bladder cancer, expansion of the BioVaxys pipeline a through new formulations based on the DPX™ immune educating platforms, progress from our licensees, and most recently, the mitigation of risk through the significant reduction of a performance milestone provision in the Asset Purchase Agreement (APA) with Horizon Technology Finance Corp., and the engagement of D12 Capital Markets Inc. and its affiliate, Foundation Markets Inc., to act as agents in connection with a brokered private placement of minimum gross proceeds of $2,000,000 and maximum gross proceeds of up to $3,000,000. Over the next year, the Company's focus is on driving organic pipeline growth by: Expanding its early-stage pipeline by pursuing multiple out licensing opportunities and research collaborations where the Company's DPX platform can address specific needs (such as for a prophylactic food allergy vaccine and the collaboration with Sona Nanotech to develop novel cancer therapies), or antigen delivery limitations faced by LNPs (e.g. mRNA vaccines and neoantigen delivery); Reducing internal risk & the considerable funding requirements of late-stage clinical studies by out-licensing maveropepimut-S (MVP-S) for advanced Relapsed-Refractory Diffuse Large B Cell Lymphoma and Ovarian Cancer, seeking a co-development partner for DPX-RSV, and pursuing non-dilutive funding for further advancement of the DPX-FLU (influenza) and DPX-anthrax vaccines. Re-engagement of investigators at CHU de Québec-Université Laval and La Fondation du CHU de Québec, for a restart of the phase 1 study of DPX-surMAGE in advanced bladder cancer. BioVaxys stands at the forefront of innovation with its mission to develop advanced treatments in oncology, infectious disease, antigen desensitization, allergy, autoimmune diseases, and other immune dysfunction based on its DPX antigen delivery and immune-educating technology platform. The DPX platform has been proven safe, well tolerated, and effective in multiple preclinical, phase 1, and phase 2b clinical studies. Through a differentiated mechanism of action, the DPX platform is a major innovation in vaccine development that is a solution for the limitations faced by vaccines using other antigen delivery methods. The DPX platform provides a new and singularly unique way to deliver active ingredients to the immune system using a novel mechanism of action that does not release active ingredients at the site of the injection, but rather forces an active uptake of immune cells and delivery into the lymphatic nodes. The programming of immune cells happens in vivo and offers a more efficient approach that mimics the natural function of the immune system. The Company's late-stage clinical stage pipeline includes MVP-S in phase 2b clinical development for advanced Relapsed-Refractory Diffuse Large B Cell Lymphoma (DLBCL) and platinum resistant Ovarian Cancer. MVP-S delivers antigenic peptides from survivin, a well-recognized cancer antigen commonly overexpressed in advanced cancers, and an innate immune activator and a universal CD4 T-cell helper peptide. MVP-S has been well tolerated and has demonstrated defined clinical benefit in multiple cancer indications as well as the activation of a targeted and sustained, survivin-specific, anti-tumor immune response. Results from a phase 1b/2 study of MVP-S in combination with low-dose cyclophosphamide in patients with recurrent ovarian cancer showed that this combination was well-tolerated and generated an overall response rate of 21% and a disease control rate of 63%. Notably, the response was observed in both platinum-resistant and platinum-sensitive patients. MVP-S, plus the immunotherapy drug Keytruda™ (pembrolizumab), also showed promising results in the treatment of patients with relapsed/refractory DLBCL, according to findings from a phase 2b study. The study analyzed MVP-S plus Keytruda and cyclophosphamide---including eight patients with relapsed/refractory DLBCL---whose functioning has been minimally affected, if at all, by their disease. Three of the six patients in the study arm experienced confirmed complete responses, meaning that there was no trace of their cancer left after treatment (2/8 of the patients had progressive disease). Kenneth Kovan, BioVaxys President & Chief Operating Officer, stated "The clinical data from MVP-S is very compelling and we think the vaccine can become a valuable tool in cancer immunotherapy. The significant investment for internal development of a later-stage program is such that it makes more sense for remaining clinical studies with MVP-S to be pursued by a company with the appropriate resources. Without going into detail, we are in early discussions with prospective licensors to achieve this objective." The Company also has data from phase 1 studies with DPX+surMAGE, a dual-targeted immunotherapy combining antigenic peptides for both the survivin and MAGE-A9 cancer proteins to elicit immune responses to these two distinct cancer antigens simultaneously. Survivin and MAGE-A9 are well characterized tumor-associated antigens frequently overexpressed in bladder tumors. Kovan further stated "We are working with the Principal Investigators at Laval University that conducted the foundational research on the surMAGE antigen combination to continue the previous phase 1 bladder cancer study. Our goal together with the investigators is to see this study funded and started in the upcoming months." The current DPX-surMAGE data has been submitted for presentation later this year at a major cancer conference. BioVaxys is seeking a partner for further clinical development of its DPX-RSV for Respiratory Syncytial Virus, which successfully completed a phase 1 human study for safety and efficacy. DPX-RSV demonstrated antigen-specific immune responses in 93% of subjects, with100% of responders in a 25μg single-dose cohort maintaining 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 F or G proteins of the virus and provide protection by neutralizing the RSV virus. Clinical measures of efficacy focus on the amount of neutralizing antibodies in the bloodstream. DPX-RSV works differently, as it targets the SH viral ectodomain of the RSV virus and, instead of neutralizing the virus, it enables the immune system to recognize and destroy RSV-infected cells. Completed BioVaxys preclinical proof of concept studies include DPX-rHA/DPX-FLU, an influenza vaccine candidate of recombinant hemagglutinin (whole protein ~300 amino acids) / whole heat killed virus package in DPX, and DPX-rPA, an and an anthrax vaccine consisting of DPX+ recombinant anthrax protective antigen. Animal challenge studies performed with lethal anthrax respiratory exposure levels with our DPX-based anthrax vaccine demonstrated 100% immunity following a single injection compared to current vaccines which require more than one dose. Kovan stated "We are looking for the right non-dilutive opportunities to further advance the clinical development of DPX-rHA/DPX-FLU with an even broader range of antigens. With DPX-rPA, we think it possible that with the excellent preclinical data, together with the clinical experience with DPX, might be sufficient to pursue registration " Pipeline Expansion Current research collaborations to expand the Company pipeline include a collaboration with AP Visionaries, Inc. of Ontario ("APVI") to jointly develop a proprietary DPX formulation to address the urgent need for a therapy to treat or alleviate the potentially life-threatening risk of certain food allergies, namely those triggered by exposure to peanut/tree nuts or eggs. Animal studies are slated to begin later this year when DPX-peanut antigen formulation is complete at The Schroeder Allergy and Immunology Research Institute of McMaster University in Ontario, an institute that consolidates clinicians, scientists, and data specialists in a one-stop shop to research the causes of life-threatening allergies and develop new treatments. Under the terms of the Collaboration, BioVaxys will provide funding for the preclinical study to evaluate in animal models the robustness of DPX antigen delivery and evaluate whether DPX transforms the underlying immunopathology of food allergy. APVI will oversee the preclinical program, with BioVaxys retaining all intellectual property rights to any resulting product. APVI will receive a royalty from BioVaxys on any gross sales from a resulting product, in addition to a milestone payment at first regulatory approval. On May 7, 2025, the Company and Sona Nanotech Inc. ("Sona") jointly announced that they entered into a research agreement to collaborate on the development of new cancer therapeutics based on the Company's DPX Immune Educating Platform in combination with Sona's Targeted Hyperthermia Therapy™, a photothermal cancer therapy that uses highly targeted infrared light and intra-tumoral gold nanorods to treat solid tumors. The collaboration will evaluate the immune stimulatory properties of DPX (without an antigen cargo) administered together with THT, as a characteristic of DPX is that it helps prime the innate immune system which in turn can activate and strengthen the adaptive immune response. The collaboration will also evaluate the combination use of THT together with a DPX formulation as a carrier for novel neoantigens expressed on the surface of tumor cells following immunotherapy, such as with THT. Neoantigens are unique proteins that are not present in healthy tissues that arise from changes in cancer cells and play a crucial role in stimulating anti-tumor immune response. Immunotherapy such as THT can trigger these tumor cell changes and the expression of neoantigens, so packaging a tumor neoantigen in DPX for presentation to the immune system is anticipated to accelerate THT's efficacy. The research studies based on the BioVaxys and Sona technologies will be conducted at Dalhousie University, Halifax, Nova Scotia, under the direction of Sona's CMO, Carman Giacomantonio, MD MSc FRCSC, Division of General and Gastrointestinal Surgery, Department of Pathology, Dalhousie University, and Barry Kennedy, PhD, of the Giacomantonio Immuno-Oncology Research Group at Dalhousie University. Other collaborations and licensing discussions are being finalized for expanding DPX formulations in the treatment of Zika virus. Licensing The Company has revenue generating licenses with Zoetis Inc. and SpayVac-for-Wildlife, Inc. for vaccines in the animal health field based on the Company's lipid encapsulation technology, with both licensors making excellent progress towards commercialization. SpayVac anticipates regulatory approval for a pZP immunocontraceptive vaccine for feral horses in the US, with supplemental regulatory submissions planned for the EU and Australia. Ongoing research with other antigens is targeting commercial aquaculture, companion animals, and other applications. On April 22, 2025, the Company announced the expansion of the Fields of Use in the current License Agreement with SpayVac to include commercial aquaculture, plus the farm-raised fish market, which will further increase BioVaxys' royalty revenue. Zoetis is preparing for regulatory submission for a pZP immunocontraception vaccine based on the Company's lipid encapsulation technology for cattle in Australia and Brazil. In a significant step to minimize risk, BioVaxys and Horizon Technology Finance Corporation ("Horizon") executed last month a follow-on Amendment ("Amendment") to the Asset Purchase Agreement dated February 11th, 2024 ("APA") for BioVaxys to acquire the entire portfolio of assets and intellectual property based on the DPX immune educating platform technology developed by Canadian biotechnology company, IMV Inc. The May 2025 Amendment lowers a performance milestone provision in the original APA for BioVaxys to demonstrate an aggregate capital raise of USD $10M, so that the new net performance milestone required to be raised in any form (including, but not limited to equity, grants, licensing fees, or loans) is now significantly lowered to USD $2,028,636. If BioVaxys is successful in meeting this milestone by September 30, 2025, the milestone requirement shall end and be of no further force or effect. To help support its objectives, on May 22, 2025, the Company announced a proposed consolidation of the common shares of the Company on the basis of ten (10) pre-consolidation Common Shares for one (1) post-consolidation Common Share. As at May 22, 2025, the Company has 293,425,203 Common Shares issued and outstanding. James Passin, CEO of BioVaxys, stated "The share consolidation is a necessary step to attract the institutional capital necessary for business development as well as to tighten up the float to increase the likelihood of sustained share appreciation on future catalysts." Immediately following the Consolidation and excluding the Common Shares to be issued in connection with this Offering, will have approximately 29,342,520 Common Shares issued and outstanding, prior to rounding of fractional Common Shares. About BioVaxys Technology Corp. BioVaxys Technology Corp. ( is a clinical-stage biopharmaceutical company dedicated to improving patient lives with novel immunotherapies based on its DPX™ immune-educating technology platform and its HapTenix© 'neoantigen' tumor cell construct platform, for treating cancers, infectious disease, antigen desensitization for food allergy, and other immunological diseases. Through a differentiated and unique mechanism of action, the DPX platform delivers instruction to the immune system to generate a specific, robust, and persistent immune response. The Company's clinical stage pipeline includes maveropepimut-S (MVP-S), based on the DPX platform, in phase 2b clinical development for advanced Relapsed-Refractory Diffuse Large B Cell Lymphoma (DLBCL) and platinum resistant Ovarian Cancer. MVP-S delivers antigenic peptides from survivin, a well-recognized cancer antigen commonly overexpressed in advanced cancers, and also delivers an innate immune activator and a universal CD4 T cell helper peptide. MVP-S has been well tolerated and has demonstrated defined clinical benefit in multiple cancer indications as well as the activation of a targeted and sustained, survivin-specific anti-tumor immune response. BioVaxys is also developing DPX+surMAGE, a dual-targeted immunotherapy combining antigenic peptides for both the survivin and MAGE-A9 cancer proteins to elicit immune responses to these two distinct cancer antigens simultaneously, DPX-RSV for Respiratory Syncytial Virus, and DPX+rPA for peanut allergy prophylaxis, as well as several viral vaccines. BioVaxys has licensed its patented liposome-based delivery platform to Zoetis, Inc. and SpayVac-for-Wildlife, Inc. for selected animal health applications. BioVaxys common shares are listed on the CSE under the stock symbol 'BIOV', trade on the Frankfurt Bourse (FRA: 5LB), and in the US (OTCQB: BVAXF). For more information, visit and connect with us on X and LinkedIn. ON BEHALF OF THE BOARD Signed "James Passin" James Passin, Chief Executive Officer Phone: +1 740 358 0555 Cautionary Statements Regarding Forward Looking Information This press release includes certain "forward-looking information" and "forward-looking statements" (collectively "forward-looking statements") within the meaning of applicable Canadian and United States securities legislation including the United States Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, included herein, without limitation, statements relating the future operating or financial performance of the Company, are forward looking statements. Forward-looking statements are frequently, but not always, identified by 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 be achieved. There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those expressed or implied in such forward-looking statements. These forward-looking statements reflect the beliefs, opinions and projections on the date the statements are made and are based upon a number of assumptions and estimates, primarily the assumption that BioVaxys will be successful in developing and testing vaccines, that, while considered reasonable by the Company, are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies including, primarily but without limitation, the risk that BioVaxys' vaccines will not prove to be effective and/ or will not receive the required regulatory approvals. With regards to BioVaxys' business, there are a number of risks that could affect the development of its biotechnology products, including, without limitation, the need for additional capital to fund clinical trials, its lack of operating history, uncertainty about whether its products will complete the long, complex and expensive clinical trial and regulatory approval process for approval of new drugs necessary for marketing approval, and, if so, whether its vaccine products will be commercially accepted and profitable, the expenses, delays and uncertainties and complications typically encountered by development stage biopharmaceutical businesses, financial and development obligations under license arrangements in order to protect its rights to its products and technologies, obtaining and protecting new intellectual property rights and avoiding infringement to third parties and their dependence on manufacturing by third parties. The Company does not assume any obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.
