PRODUCT CANDIDATES

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VET3-TGI: A potent combination of TGF-B inhibition and IL-12 expression derived from the VET™ BACKBONE

VET3-TGI builds on the VET™ backbone by adding two therapeutic transgenes encoding IL-12 and a TGF-B inhibitor. TGF-B is known to be a potent suppressor of immune responses and is a major factor in determining the patient response to checkpoint therapies. Lack of specificity and poor tumor infiltration has so far prevented the clinical approval of TFG-B inhibitors in cancer treatment.

The combination of these two factors, alongside the systemic targeting of the tumor via the oncolytic viral platform, creates a powerful immunotherapeutic.

Paul Youm

Vice President, Corporate Development and Alliance Management

Paul Youm is a seasoned attorney and a corporate and business development professional with over 10 years of experience in the biotechnology industry. Prior to joining KaliVir, Paul served as the general counsel and/or head of business development at various biotech companies in immuno-oncology, gene therapy and regenerative medicine, including SillaJen, Inc. (formerly Jennerex), where he held a highly versatile role with cross-functional responsibilities in legal, operations, strategy and corporate development. Paul holds a J.D. equivalent masters degree from Sogang Law School in Korea and a B.S. bachelor’s in biomedical engineering from Duke University.

URSULA FRITSCH, PharmD

Chief Regulatory Officer

Ursula has over 30 years of experience in the biotechnology and pharma industry. Ursula has overseen global Regulatory Affairs for a variety of therapeutics across the development life-cycle, with success at the pre-IND, IND, BLA/NDA, Advisory Committee, post-marketing and commercial stages. Ursula has conducted successful regulatory and inspection negotiations, 15 years with oncolytic viruses, with authorities in US, Europe, UK, China, South Korean, Australia, Eastern Europe, Canada, Mexico and South American countries. Ursula has acted as head of regulatory or held positions of increasing responsibility at companies such as Genentech/Roche, Onyx Pharmaceuticals and Jennerex Biotherapeutics. Prior to joining Kalivir, Ursula served as the Chief Regulatory Officer at CG Oncology. Ursula received her Doctorate of Clinical Pharmacy from Creighton University.

SCHOND GREENWAY

Chief Financial Officer

Schond Greenway joined KaliVir Immunotherapeutics as Chief Financial Officer (CFO) in August 2024. He brings over 25 years of experience in corporate finance and investment analysis, with deep expertise in the life sciences and financial services sectors, particularly in capital markets and corporate financial transactions. Before KaliVir, Schond served as CFO at MindMed (MNMD), where he was responsible for all aspects of corporate finance, investor relations, public relations, and information technology. Before that, he held the CFO position at Avalo Therapeutics (AVTX). Earlier in his career, he held executive leadership roles at Mesoblast Ltd (MESO), Halozyme Therapeutics (HALO), and DURECT Corporation (DRRX). His investment banking career began at Morgan Stanley, and he later became Vice President, Healthcare Desk Analyst at Barclays Capital.

Schond has participated in and advised on transactions totaling over $30 billion during his tenure in investment banking. He also played a critical role in securing more than $1.5 billion in growth equity, debt capital, and R&D funding from biopharmaceutical companies during his leadership tenures at MindMed, Avalo Therapeutics, and other life sciences organizations.

Schond earned a B.S. in Computer Information Systems from Florida A&M University and an MBA from the Darden School of Business at the University of Virginia.

JAMES M. BURKE, M.D.

Chief Medical Officer

Dr. James Burke is a University of California, San Francisco trained hematologist and oncologist who has led clinical development of gene therapy and oncolytic viruses for cancer for over 15 years including first in human through Phase 3 studies. Most recently, Dr Burke served as Chief Medical Officer of Sillajen (previously Jennerex) leading Phase 1-3 global development of a vaccinia virus platform for multiple cancers including HCC, RCC, and CRC.

The global Phase 3 registration trial targeting advanced HCC represents one of the largest oncolytic studies conducted to date spanning four continents including North America, Europe, Australia, and Asia. This Phase 3 study was the first oncolytic virus study conducted by a foreign biotech in China and one of only a few OV trials to ever be conducted in mainland China. Aside from Sillajen, Dr Burke led initial Phase 1-2 clinical development of Turnstone’s maraba virus prime-boost oncolytic virus program as CMO through initial studies and fund raising.

Dr Burke started his career at Cell Genesys spearheading early gene and immunotherapy studies including oncolytic adenovirus, lentivirus, AAV, and tumor vaccine programs. In addition to his biotechnology experience, Dr Burke directed studies as a clinical scientist including first in human studies in oncolytic viruses, tumor vaccines, as well as other cancer therapeutics in Phase 1-3 development.

Throughout his career he has had extensive interaction with global regulatory authorities and key academicians, led clinical development of numerous agents, built expert research teams, presented his research findings in key scientific journals and symposia, and led medical discussions and negotiations with external financing entities including venture capital and pharma.

ADINA PELUSIO

Chief Development Officer

Ms. Pelusio has more than 20 years of experience in drug development. Before joining KaliVir, she served as Senior Vice President of Clinical Operations at Turnstone Biologics, where she oversaw the advancement of candidate oncolytic viruses, cancer vaccines and adoptive cell therapies into clinical trials. Prior, Ms. Pelusio spent 10 years at SillaJen, Inc. (formerly Jennerex Biotherapeutics) where she led the introduction of oncolytic viruses into 17 countries across Phase I-III clinical trials. She holds an M.S. from the University of Florida and is pursuing an M.P.H. from Harvard University T.H. Chan School of Public Health.

STEPHEN H. THORNE, Ph.D.

Chief Scientific Officer

Stephen Thorne co-founded Kalivir in 2019 and currently serves as Chief Scientific Officer. He is a leader in the field of oncolytic viral immunotherapy and previously co-founded Western Oncolytics, BioEclipse and Jennerex, which is currently advancing Pexa-Vec through late-stage clinical trials.

Stephen was a Professor of Cell Biology and Immunology at the University of Pittsburgh and received his B.A. from Oxford University, UK and Ph.D. from Imperial College of London. Stephen has served in post doctorate roles at Surrey University, Cancer Research UK, and Stanford University and has authored more than 100 scientific publications in the field.

HELENA CHAYE, Ph.D., J.D.

Chief Executive Officer

Helena has over 23 years of experience in the biotechnology industry having held leadership positions in operations, corporate affairs, business development and IP management primarily in oncolytic virotherapy development. Most recently, Helena served as Chief Business Officer at SillaJen Biotherapeutics, Inc. where she managed all operations including corporate and business development strategies, R&D strategy and intellectual property. Prior to joining SillaJen, Helena held the positions of VP of Corporate Affairs & IP at Jennerex Biotherapeutics and the Director of Business Development at MediGene. Helena received her B.S. in Biochemistry and her Ph.D. in Genetics from the University of British Columbia and her J.D. from Dalhousie University.