HDT Bio Corp.

HDT Bio’s LION ™ platform to support malaria vaccine development by MalarVx SEATTLE, WA, USA I January 15, 2025 I MalarVx, Inc., a clinical-stage vaccine company, is proud to announce a license to HDT Bio’s proprietary self-amplifying replicon RNA (repRNA) and lipid nanoparticle (LION™) technologies for use in malaria vaccines. In addition to HDT Bio’s technologies, the agreement provides MalarVx additional support from HDT to develop and commercialize malaria vaccines. This license expands the long-standing relationship between the parties. Malaria was responsible for 597,000 deaths and 263 million cases in 2023, according to the World Health Organization. Despite the expenditure of $4 billion per year on control 1 , malaria deaths and cases have not substantively changed over the last decade. Consequently, a safe, effective, long-lasting, easy-to-use, and cost-effective vaccine to prevent malaria is desperately needed. HDT Bio Corp. is a clinical-stage biopharmaceutical company specializing in advanced RNA vaccine technologies, including the company’s proprietary LION nanoparticle delivery system. LION is well-suited for use in vaccines to prevent viral and bacterial infections. “We are excited to contribute our expertise in RNA vaccine technologies in an effort to develop malaria vaccines with MalarVx,” said Steve Reed, Ph.D., CEO of HDT Bio. “Our LION platform has a demonstrated ability to rapidly generate potent, durable immune responses with a favorable safety profile.” “This collaboration is an example of our aspiration to enable a new generation of global health technologies,” said Curt Malloy, HDT SVP Strategic Operations.  “We are dedicated to applying our technology to address critical global health challenges. From combating infectious diseases like malaria to pioneering breakthroughs in cancer prevention and treatment, we remain committed to catalyzing innovations that address unmet global health needs.” MalarVx has also demonstrated the potential of LION-based vaccines to prevent infections caused by Plasmodium parasites, the pathogens responsible for malaria in humans and other animals. “We believe the attributes of LION-based vaccines, including increased potency, product stability, and simplified manufacturing, are essential for vaccines designed for use in resource limited environments,” said James Davie, MalarVx CEO. “Of particular interest is the potential for a multi-species vaccine capable of preventing Plasmodium falciparum and Plasmodium vivax infections, since these pathogens are responsible for most cases of malaria in humans.” Dr. Marion Avril, Ph.D., MalarVx Program Director, added, “We recognize the transformative potential of our vaccines to combat one of humanity’s most devastating diseases. Our collaboration with HDT Bio is a significant step towards achieving a world free from malaria. Together, we are committed to advancing innovative solutions that will save lives and improve health outcomes for millions of people globally.” About MalarVx MalarVx is a Seattle-based clinical-stage biopharmaceutical company developing vaccines to prevent malaria. Current efforts focus on the clinical development of a replicon RNA-based vaccine for the prevention of Plasmodium falciparum infection and on culturing the mosquito stages of the parasite for the cost-effective production of whole organism vaccines. For more information on MalarVx and its work on safe and effective malaria vaccines, visit www.malarvx.com About HDT Bio HDT Bio is a Seattle-based, clinical-stage biopharmaceutical development company. With core technology and expertise in nucleic acid formulation, the company develops products that seek to harness host-directed immune responses. HDT Bio’s work focuses on infectious disease and oncology vaccines and therapeutics through early-stage collaborations with partners worldwide. The company’s vaccine platforms combine formulation and adjuvant ingredients to stabilize and deliver RNA to the immune system to stimulate responses. HDT Bio’s repRNA/LION™ was the first self-amplifying RNA vaccine platform to receive regulatory authorization. For more information on HDT Bio platforms, visit www.hdt.bio 1 “Malaria Cases Up Again in 2023, African Children Worst Hit, WHO Reports.” Reuters, December 11, 2024. https://www.reuters.com/business/healthcare-pharmaceuticals/malaria-cases-up-again-2023-african-children-worst-hit-who-reports-2024-12-11/ . SOURCE: MalarVx; HDT Bio

A single-RNA-based vaccine against enterovirus-D68, a respiratory virus and causative agent of severe paralytic disease in children, by the Erasmus group shows great promise in generating broadly cross-neutralizing antibodies in mice and macaque models of infection. Enterovirus-D68 (EV-D68; see Glossary), a member of the Picornaviridae positive-sense RNA virus family, is of increased public health concern due to its association with both severe respiratory disease and acute flaccid myelitis (AFM), a paralytic disease with similarities to poliomyelitis [1,2]. The rise in both prevalence and severity of disease associated with EV-D68 makes the need for an effective vaccine more necessary than ever. While enveloped viruses like coronaviruses have a viral This work was supported by National Institutes of Health/National Institute of Allergy and Infectious Diseases (NIH/NIAID) grants R01141359 and R01104928. N.P. is supported by NIH/NIAID training grant AI095190. W.T.J. had a role in a prior grant application led by members of the HDT Bio team who were part of the published study. Glossary Acute flaccid myelitis (AFM) a paralytic disease, primarily in young children, associated with viral infection, with global outbreaks in 2012, 2014, 2016, and 2018. Clade a group of viruses within a species thought to have evolved from a common ancestor and displaying common characteristics, often but not always with regards to immune responses. Enterovirus-A71 (EV-71) a respiratory virus, first isolated in 1969, which is extremely similar to EV-D68 in genome organization and capsid structure and is Acute flaccid myelitis (AFM) a paralytic disease, primarily in young children, associated with viral infection, with global outbreaks in 2012, 2014, 2016, and 2018. Clade a group of viruses within a species thought to have evolved from a common ancestor and displaying common characteristics, often but not always with regards to immune responses. Enterovirus-A71 (EV-71) a respiratory virus, first isolated in 1969, which is extremely similar to EV-D68 in genome organization and capsid structure and is

ROCHESTER, Minn.--( BUSINESS WIRE )--RION, a clinical-stage regenerative medicine company pioneering exosome-based therapeutics, today announced the appointment of five distinguished leaders to its Advisory Board. These new advisors bring decades of expertise in their respective fields, ranging from orthopedic & plastic surgery to infectious diseases, military medicine, biomanufacturing and government health strategy, further positioning RION as a leader in innovative regenerative medicine. “We are thrilled to welcome this esteemed group of experts to our team,” said Dr. Atta Behfar, Co-Founder of RION. “Their exceptional track records in clinical practice, biomanufacturing, public health leadership, and scientific innovation will play a crucial role as we continue to advance our groundbreaking platform technology and bring transformative regenerative therapies to patients worldwide.” Advisory Board Members: James B. Peake, M.D . Dr. James Peake, a retired Lieutenant General and former U.S. Army Surgeon General, brings a wealth of experience from his military career and public service as the Secretary of the U.S. Department of Veterans Affairs under President George W. Bush. Dr. Peake has commanded Army medical facilities worldwide and played a pivotal role in shaping healthcare delivery for veterans. His leadership continues in the private sector, where he contributes to the advancement of healthcare strategy at CGI. Raquel C. Bono, M.D., MBA, FACS A board-certified trauma surgeon and retired Vice Admiral, Dr. Raquel Bono made history as the first woman and Asian-American to hold a three-star admiral rank in the U.S. Navy’s medical field. As Director of the Defense Health Agency, she oversaw management of all 55 military treatment facilities and more than 300 associated clinics. Before that, from 2013 to 2015, she served as the 11th chief of the Navy Medical Corps. Dr. Bono’s extensive leadership roles include board membership at Humana and healthcare consulting, shaping value-based care strategies in both military and civilian healthcare systems. Steven L. Moran, M.D. Dr. Moran is a Professor of Plastic Surgery and Orthopedic Surgery at Mayo Clinic, Rochester, and staff surgeon at the Shrine Clinic for Sick Children in Minneapolis. He is the former Chairman of the Division of Plastic Surgery at Mayo Clinic, Dr. Moran is now the Surgical Director of the Mayo Clinic’s vascularized composite tissue allotransplant program. His renowned expertise spans wrist surgery, congenital hand surgery, and microsurgical reconstruction of the upper extremity. With over 375 peer-reviewed publications, numerous book chapters, and edited textbooks, Dr. Moran is recognized globally for his research in tissue engineering and regenerative medicine. Andrew Omidvar, Ph.D. Dr. Andrew Omidvar, Vice President of Government R&D at Philips Healthcare, leads large-scale healthcare innovation programs, including government partnerships with BARDA and the Gates Foundation. His strategic expertise in securing billion-dollar funding for transformative healthcare solutions and his leadership at MITRE and Motorola make him an invaluable asset to RION’s advisory team. Steve Reed, Ph.D. A leading expert in infectious disease research and vaccine development, as well as drug delivery methods, Dr. Steve Reed is the co-founder and CEO of HDT Bio. Dr. Reed has a long history of impactful contributions, including developing the first defined vaccines for tuberculosis, leishmaniasis, and leprosy. His work has garnered over $140 million in grants, and his career includes founding key biotech companies such as Corixa Corporation and Immune Design Corp., both of which transformed cancer and infectious disease therapeutics. About RION RION emerged out of the Mayo Clinic after two decades of research and innovation, in the Van Cleve Cardiac Regenerative Medicine Program, leading to the discovery that the driving force behind tissue repair was exosome signaling. Located in Rochester, MN, RION is internationally recognized for its pioneering advancements in isolating and mass-producing platelet-derived regenerative exosomes into shelf stable PEP™. RION is advancing its proprietary biologic PEP™ platform in multiple clinical trials in various therapeutic areas, including wound healing, cardiology, and orthopedics.