Biovaxys Technology Corp · CSE:BIOV
Biovaxys Technology — Investor Presentation (February 2021)
31 slides from Biovaxys Technology's investor presentation, February 2021
Slide 1: Waking up the Human Immune System
Waking up the Human Immune System Immunotherapeutic vaccine platforms and diagnostics harnessing the power of T-cells 1
Slide 2: Forward Looking Statement
FORWARD LOOKING STATEMENT The statements in this presentation are "forward-looking" statements that are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements involve significant risk
Slide 3: Transitioning to a Revenue Generating Business Model
Transitioning to a Revenue Generating Business Model 3
Slide 4: Leadership Team
Leadership Team Founder and Founder and Founder, President and Chief Financial Officer Chief Medical Officer Chief Executive Officer Chief Operating Officer James Passin Kenneth Kovan David Berd, M.D. Lachlan McLeod, CPA 4
Slide 5: Board of Directors
Board of Directors JAMES PASSIN ● See Founders & Senior Management DAVID WANG ● Seasoned medical technology executive and Healthcare Consultant for South America for Omron, an USD$1.5 billion market capitalization company listed on the Tokyo Stock Exchange. ● Former CEO of CAUS Capital and former CE
Slide 6: Advisors
Advisors CHARLES J. DUNTON, MD Dr. Dunton is a gynecologist/oncologist in Indiana. He received his medical degree from Jefferson Medical College and has been in practice for 30+ years. Dr. Dunton has been Chief, Division of Gynecologic Oncology Department of Obstetrics and Gynecology, Main Line Heal
Slide 7: Advisors
Advisors ADAM COUTTS, PHD Dr. Coutts is a Senior Research Fellow at Magdalene College, University of Cambridge, and a Research Associate in the Department of Sociology, University of Cambridge. Dr. Coutts' research focuses on the social and political determinants of health looking at how non-health
Slide 8: Haptenized Antigen Vaccine Platform
Haptenized Antigen Vaccine Platform ● Unique established approach “teaches” the patient's immune system to recognize and target viral or tumor antigens as foreign via process of haptenization ● Antigens are modified w/ a chemical called a ‘hapten’ (Examples: dinitrophenyl/DNP, sulfanilic acid/SA); m
Slide 9: The BioVaxys Difference
The BioVaxys Difference Derisked Development BIOVAXYS Technology Corp. (CSE:BIOV, OTCQB:BVAXF, FR:5LB ) ● BioVaxys LLC founded in 2018 to improve on the ‘first-generation’ of haptenized antigen vaccines & leverage previous vaccine development efforts by Dr David Berd while at Thomas Jefferson Univer
Slide 10: Product Portfolio
Product Portfolio PRODUCT INDICATION PRECLINICAL IND/PHASE I PHASE II/III Monovalent Sars-CoV-2 BVX-0320 Vaccine BVX-0204 HPV Viral Vaccine (Partnered in EU w/ ProCare Health) BVX-0918A (Partnered in EU w/ ProCare Health) Ovarian Cancer BVX-0918C (Partnered in EU w/ Cervical Cancer ProCare Health) P
Slide 11: Sars-CoV-2 And Ovarian Cancer
Sars-CoV-2 And Ovarian Cancer Major Cause of Death in the US SARS-COV-2 ● 105 million infections and over 2.28 million deaths worldwide 1 ● 26.6 million confirmed infections in the US, with 451,000 deaths1 ● Viral mutations creating new dangerous variants OVARIAN CANCER ● ~300,000 cases diagnosed wo
Slide 12: SARS-CoV-2
SARS-CoV-2 ● The “S-spike” protein gives coronaviruses their name. They allow the virus to attach to and enter human cells. ● S protein is immunogenic and antibodies against it neutralized the virus. ● “BVX-0320” is haptenized SARS-CoV-2 s-spike protein ● Proven vaccine approach in targeting surface
Slide 13: BVX-0320 Product Profile
BVX-0320 Product Profile ● 96.4% positive antibody response detected at week 6 following two injections of BVX-0320 together with the immunological adjuvant, QS21, to 28 mice at four dosage levels. ○ Production of neutralizing antibodies to live SARS-CoV-2 ● Activates CD4+ helper T cells and CD8+ ki
Slide 14: BVX-0320: Straightforward and Flexible Conjugation
BVX-0320: Straightforward and Flexible Conjugation + 2,4-Dinitrobenzenesulfonic acid hydrate Lys/S1 SARS2 protein [Millipore-Sigma cat no: 556971] Max haptenized S1 protein (DNP+protein) “Cassette” approach of adding new antigens gives flexibility to quickly target new viral mutations/variants and o
Slide 15: BVX-0320: Development Plan 2021
BVX-0320: Development Plan 2021 ● In vivo preclinical Program (completed 12/2020) ○ FDA Center for Biologics Evaluation and Research (CBER) published guidance ● Phase I Clinical Development Partner (2Q2021) ● CHO cell line / expression system and GMP s-protein bioproduction with Wuxi Biologicals (3Q
Slide 16: CoviDTH Immuno Diagnostic
CoviDTH® Immuno Diagnostic Provisional Patent Application (October 2020) Current COVID-19 diagnostics emphasize SARS-CoV-2 antibody detection, not T-cell activation. ● Hindered by false (-) & (+) ● T-cell testing potentially more accurate; measures active immune system infection response ● Needs spe
Slide 17: Covid-T Development Plan 2021
Covid-T™ Development Plan 2021 ● EUA request filed (2/2021) ● FDA CBER Assignment (3/2021) ● Submission of Pre-IND Meeting Request and Briefing Document (4/2021) ● Wuxi Biologicals develops CHO cell expression system for recombinant SARS-CoV-2 s-protein (4/2021) ● Rabbit model acute toxicity study (
Slide 18: Ovarian Cancer
Ovarian Cancer ● Platinum-based chemotherapy failures have limited life expectancy even with multiple salvage regimens. New treatments are needed. ● Checkpoint antibodies alone work only occasionally. ● Stimulation of antitumor immunity achieved with DNP- modified autologous, vaccine, as shown by AV
Slide 19: The BioVaxys Difference: Bi-Haptenization
The BioVaxys Difference: Bi-Haptenization Bihaptenization: SUPERIOR TO Two haptens Anti-CTLA4 & SINGLE HAPTEN conjugated to the Anti-PDA IN TUMOR patients own Antibodies VACCINES tumor cell • Early autologous haptenized vaccines based on single hapten (DNP) conjugated to the patients own tumor cell,
Slide 20: The BioVaxys Difference: Anti-CTLA4 & Anti-PDA Antibodies
The BioVaxys Difference: Anti-CTLA4 & Anti-PDA Antibodies Bihaptenization: SUPERIOR TO Two haptens Anti-CTLA4 & SINGLE HAPTEN conjugated to the Anti-PDA IN TUMOR patients own Antibodies VACCINES tumor cell • Checkpoint inhibitors function: Removes the “brakes” on the immune system that tumors exploi
Slide 21: Single Hapten Phase I/II Clinical Results
Single Hapten Phase I/II Clinical Results Stage III-IV Platinum-Resistant Ovarian Cancer Median Survival Ovarian Cancer (Platinum Resistant) Competitive Comparison 25 22.68 20 16.6 OVAX plus 1 cyclophosphamide 15 12.9 AVASTIN (bevacizumab) + Chemo Chemotherapy 10 5 0 21
Slide 22: Single Hapten Vaccine
Single Hapten Vaccine Previous Development - Phase II Efficacy Metastatic Melanoma % Overall Survival Competitive Comparison 100 90 80 80 70 68.4 60 63 MVAX Stage IIIB & IIIC 50 46 44 40 Keytruda 30 (pembrolizumab) Stage 24 III/IV 20 10 NA NA 0 0 1 Year 2 Year 5 Year 22
Slide 23: Co-Development and Commercialization Collaboration with ProCare Health
CO-DEVELOPMENT, JOINT COMMERCIALIZATION AND MARKETING COLLABORATION GYNECOLOGICAL CANCER & HPV VACCINES ○ P&G spin-off (2012) focused on Women’s Health ○ Fully integrated EU pharmaco w/ established KOL relationships, marketing & sales presence in the EU ○ BioVaxys+Procare Agreement (2/2021): ○ USD$9
Slide 24: BVX-0918A: Ovarian Cancer Development Plan
BVX-0918A: Ovarian Cancer Development Plan ● Compassionate use in EU of bihaptenized vaccine in Stage III/IV ovarian cancer ○ Study design & CRO selection with ProCare Health (2Q/2021) ● Bihaptenized vaccine (only): Safety primary endpoint, immunological data is secondary endpoint ● Protocol will re
Slide 25: BVX-0918A: Manufacturing & Regulatory Summary
BVX-0918A: Manufacturing & Regulatory Summary ● GMP bioproduction contract w/ BioElpida (Lyon, France) ● Well-understood four-step process: 1. Tumor acquisition 2. Tumor processing and vaccine production (tumor cell dissociation, irradiation, haptenization, cell counting, aliquoting into single dose
Slide 26: Papilocare
Papilocare® HPV INFECTION: 528,000 CASES OF CERVICAL CANCER AND 266,000 CERVICAL CANCER DEATHS EACH YEAR1 ● 1st and only product for treatment and prevention HPV-dependent cervical lesions ● Marketed in EU as a Class IIa medical device ● € for 28 European countries ● Significant results in both cerv
Slide 27: Immuno-Products Pipeline Expansion
Immuno-Products Pipeline Expansion HAPTENIZED PROTEIN VACCINE PLATFORM EXPANSION ○ Multivalent SARS-CoV-2 vaccine for emerging B.1.1.7 and B.1.351 variants ○ HPV, VZV, SARS, MERS, other viruses ○ Phase I/II program in cervical cancer, colon, melanoma and/or other cancers COVIDTH® ○ Expansion of diag
Slide 28: Investment Opportunity
Investment Opportunity ● Experienced team with Avax pedigree, oncology and antivirals experience ● Significant revenue potential from marketing Papilocare™ in the US ● CoviDTH® is first-in-world disposable T-cell diagnostic using recombinant s-protein ● Innovative, potentially life saving therapy fo
Slide 29: Contact
Contact James Passin, CEO BioVaxys Technology Corp. Email: jpassin@biovaxys.com Cell: +1 917 215 6659 www.biovaxys.com 29
Slide 30: Appendix A: IP Portfolio
Appendix A: IP Portfolio BIOVAXYS-OWNED ●US Patent Application HAPTENIZED CORONAVIRUS SPIKED PROTEINS, #62/992,722 (Filed 3/20/2020), PCT Application filed 3/2021 ●US Patent Application BIHAPTENIZED AUTOLOGOUS VACCINES AND USES THEREOF #62/735,381 (9/24/2018) and #62/746,066 (Filed 10/16/2018), mult
Slide 31: Appendix C: Founders & Senior Management Team
Appendix C: Founders & Senior Management Team JAMES PASSIN: Founder & Chief Executive Officer ●Former Fund Manager at FG2 Advisors, LLC, an affiliate of New York-based Firebird Management LLC. ●He has 20 years of experience as a professional investor, with a deep experience of financing and developi
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