Biovaxys Technology Corp · CSE:BIOV
Biovaxys Technology — Investor Presentation (October 2020)
33 slides from Biovaxys Technology's investor presentation, October 2020
Slide 1: Waking up the Human Immune System
Waking up the Human Immune System Antiviral and anticancer vaccine platforms harnessing the power of T-cells
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: BioVaxys Founders
BioVaxys Founders Founder and Founder, President and Founder and Chief Executive Officer Chief Operating Officer Chief Medical Officer James Passin Kenneth Kovan David Berd, M.D. 3
Slide 4: Board of Directors
Board of Directors James Passin • See Founders & Senior Management Jeremy Poirier • 15+ years experience in the capital markets • Co-founder, former director & officer of Pure Energy Minerals Limited (TSXVX: PE) • Former CEO of Bearing Lithium (CSE: BLILF); Led transformation of the company through
Slide 5: Senior Management Team
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 developing venture -stage co
Slide 6: Senior Management Team
Senior Management Team DAVID BERD, MD | Founder & Chief Medical Officer • Medical oncologist with lifelong record of clinical research in medical oncology and cancer immunotherapy. • Founded AVAX Technologies, inventor of cancer vaccines MVax™ and OVax™, • Chief Medical Officer 2005-2008. National D
Slide 7: Clinical Stage Immunotherapeutics
Clinical Stage Immunotherapeutics PRODUCT INDICATION PRECLINICAL IND/PHASE I PHASE I/II BVX-0320 COVID-19 Ovarian BVX-0918A Cancer BVX-0918B Melanoma 7
Slide 8: Haptenized Protein Vaccine Platform
Haptenized Protein 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 INC. Founded in 2018 to improve on the technology of protein haptenization & leverage previous vaccine development efforts by Dr. David Berd while at Thomas Jefferson University and the former Avax Technologies, Inc. THE LEGACY OF HAPTENIZED VACC
Slide 10: COVID-19 and Ovarian Cancer
COVID-19 and Ovarian Cancer Major Cause of Death in the US SARS-COV-2 Virus ● 25.5 million infections and over 852,000 deaths worldwide 1 ● 5.89 million confirmed infections in the US, with 185,000 deaths 1 ● There are no vaccines or curative therapies available OVARIAN CANCER ● ~300 ,000 cases diag
Slide 11: 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 12: BVX-0320: Straightforward Conjugation
BVX-0320: Straightforward Conjugation + 2,4-Dinitrobenzenesulfonic acid hydrate [Milliporesigma cat no: 556971] Lys/S1 SARS2 protein max haptenized S1 protein (7 - 30 DNP/molecule) 12
Slide 13: Non-GMP Production of BVX-0320
Non-GMP Production of BVX-0320 • 3mg of S1 protein – shipped as a control to Charles River • 0.2mg of S1 protein – reference for analytics • 4.8mg of S1 protein – conjugation with DBSA Buffer exchange the protein into 0.1M sodium bicarbonate (pH8.2) Mix with freshly prepared 2,4 DBSA in 0.1M sodium
Slide 14: BVX-0320: Potential program advantages
BVX-0320: Potential program advantages ● Haptenized proteins are known to induce potent T-cell responses as well as antibodies ● A recent study 1 demonstrates the value of inducing a T-cell response ○ In a sample of patients who recovered from SARS-CoV-2 infection, all of the patients carried helper
Slide 15: Competitive approaches
Competitive approaches ● SARS-CoV-2 vaccines in development include DNA, live attenuated virus, non-replicating viral vector, protein subunit and RNA ● 150 vaccine candidates (as of September 2020), 78 confirmed as active, with 73 in the exploratory or preclinical stages ● Clinical development: ○ Mo
Slide 16: BVX-0320: Development Plan
BVX-0320: Development Plan Completed • Provisional patent application for Haptenized SARS-CoV-2 Spike Protein Vaccine (03/20/20) • Development & validation of nonGMP manufacturing protocol • Production & validation of non-GMP supply of BVX-0320 (MilliporeSigma) • Murine immune response/tolerability
Slide 17: 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 AVA
Slide 18: SARS-CoV-2 Diagnostic Program
SARS-CoV-2 Diagnostic Program 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 might be more accurate; measures active immune system infection response ● Needs spe
Slide 19: The BioVaxys Difference: Bi-haptenization
The BioVaxys Difference Bi-haptenization Bihaptenization: SUPERIOR TO Two haptens Anti-CTLA4 & SINGLE HAPTEN conjugated to Anti-PDA IN TUMOR the patients own Antibodies VACCINES tumor cell • Early autologous haptenized vaccines based on single hapten (DNP) conjugated to the patients own tumor cell,
Slide 20: Anti-CTLA4 & Anti-PDA Antibodies
The BioVaxys Difference Anti-CTLA4 & Anti-PDA Antibodies Bihaptenization: SUPERIOR TO Two haptens Anti-CTLA4 & SINGLE HAPTEN conjugated to Anti-PDA IN TUMOR the patients own Antibodies VACCINES tumor cell • Checkpoint inhibitors function: Removes the “brakes” on the immune system that tumors exploit
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 22.68 25 22.68 16.6 20 16.6 OVAX plus 1 12.9 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: BVX-0918A: Ovarian Cancer Development Plan
BVX-0918A: Ovarian Cancer Development Plan ● Compassionate use trial in EU of bihaptenized vaccine in ovarian cancer (Stage III/IV) ○ 2021: Study design & CRO selection with anticipated partner ProCare Health (Barcelona) ■ Bihaptenized vaccine (only): Safety primary endpoint, immunological data is s
Slide 24: BVX-0918A: Manufacturing & Regulatory Summary
BVX-0918A: Manufacturing & Regulatory Summary ● Utilization of CMOs (no production facility investment) ● Well-understood four-step process: 1. Tumor acquisition 2. Tumor processing and vaccine production (tumor cell dissociation, irradiation, haptenization, cell counting, aliquoting into single dos
Slide 25: BVX-0918A: Ovarian Cancer Development Plan
BVX-0918A: Ovarian Cancer Development Plan Anticipated collaboration ● Compassionate Use Trial ● Spanish pharma w/ strong OBY/GYN/Oncology product focus (marketing fit w/ ovarian cancer) ○ Regulatory expertise, established OL relationships, and marketing & sales presence in the EU ○ Study center rec
Slide 26: Pipeline expansion
Pipeline expansion HAPTENIZED PROTEIN VACCINE PIPELINE EXPANSION ● SARS, MERS, influenza, other viruses ● Phase I/II program in renal cell, colon, melanoma and/or other cancers T-CELL DRUG DISCOVERY PROGRAM ● Collect and “bank” T-cells from patients pre/post vaccine administration (Unique to BioVaxy
Slide 27: Vision
Vision Manufacturing Scale-Up for BVX-0320, BVX-0918A GMP Production scale-up, BVX- Non-GMP production of 0918A Compassionate Use US approval for BVX- BVX-0320, Preclinical Trial in EU, Collaboration for 0918A in ovarian cancer, Development of BVX- banked T-cell program, Submit IND for BVX-0918B in
Slide 28: Investment Terms / Use Of Proceeds
Investment Terms / Use Of Proceeds INVESTMENT TERMS Successfully completed private placement of up to 13,738,235 Units at a price of $0.22 per Unit, for gross proceeds of $3,022,411. Each Unit was comprised of one Common Share and one-half of one whole Common Share purchase warrant (each whole warra
Slide 29: Investment Opportunity
Investment Opportunity ● Experienced team with Avax pedigree, oncology and antivirals experience ● Innovative, potentially life saving therapy for COVID-19 and cancers with unmet medical needs/insufficient treatment options ● Benefit of >$100M prior R&D investment ● Compelling clinical data and reco
Slide 30: Contact
Contact James Passin, CEO BioVaxys Inc. Email: [email protected] Cell: +1 917 215 6659 USA Office BioVaxys inc. 1177 Avenue of the Americas 5th Floor, New York, NY 10036 USA +1 646.452.7054 Canadian Headquarters BioVaxys Technology Corp. 905 West Pender Street, Suite 503 Vancouver, British Columb
Slide 31: Appendix A: IP Portfolio
Appendix A: IP Portfolio BIOVAXYS-OWNED ● HAPTENIZED CORONAVIRUS SPIKED PROTEINS, #62/992,722 (filed 3/20/2020) ● BIHAPTENIZED AUTOLOGOUS VACCINES AND USES THEREOF #62/735,381 (9/24/2018) and #62/746,066 (10/16/2018) ○Composition of Matter and Use patents for bi-haptenized autologous cancer vaccines
Slide 32: Appendix B: Capital Structure
Appendix B: Capital Structure SHARES OUTSTANDING Pre-Acquisition 26,364,856 BioVaxys Acquisition Consideration 29,000,000 Common Shares Issued to Advisors 2,100,000 New Capital Raised 13,738,235 TOTAL PRO FORMA 71,203,091 OPTIONS/WARRANTS OUTSTANDING Pre-Acquisition Options 1,016,996 Pre-Acquisition
Slide 33: Thank You!
BIOVAXYS Thank You! 33
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