Biora Therapeutics, Inc. · OTC:BIORQ
Biora Therapeutics — Investor Presentation (August 2022)
26 slides from Biora Therapeutics's investor presentation, Aug 15, 2022
Slide 1: Corporate Presentation August 2022
CORPORATE PRESENTATION August 2022 Exhibit 99.2
Slide 2: Forward-Looking Statements
FORWARD-LOOKING STATEMENTS This presentation contains “forward-looking statements” within the meaning of the federal securities laws, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical fa
Slide 3: About Biora Therapeutics
ABOUT BIORA THERAPEUTICS Our mission is to reimagine therapeutics and their delivery TARGETED ORAL DELIVERY OF BIOTHERAPEUTICS Treatment at the site of disease in the GI tract could improve outcomes for patients with inflammatory bowel disease SYSTEMIC ORAL DELIVERY OF BIOTHERAPEUTICS Ingestible tec
Slide 4: Therapeutic Pipeline
THERAPEUTIC PIPELINE PROGRAM PROGRAM INDICATION DESIGN/FEASIBILITY PRECLINICAL CLINICAL TARGETED THERAPEUTICS DDS Device -- PGN-600 Tofacitinib + Device UC PGN-001 Adalimumab + Device UC SYSTEMIC THERAPEUTICS OBDS Device -- PGN-OB2 GLP-1 agonist + Device Diabetes PGN-OB1 Adalimumab variant + Device
Slide 5: Targeted Therapeutics
OOO TARGETED THERAPEUTICS
Slide 6: Ulcerative Colitis: The Treatment Gap
ULCERATIVE COLITIS: THE TREATMENT GAP Despite therapeutics targeting different pathways, few patients achieve long-term remission Alsoud D, Verstockt B, Fiocchi C, Vermeire S. Breaking the therapeutic ceiling in drug development in ulcerative colitis. Lancet Gastroenterol Hepatol. 2021;6(7):589-595.
Slide 7: Unmet Need in Ulcerative Colitis
UNMET NEED IN ULCERATIVE COLITIS Targeted delivery could enable rapid induction and improve patient response THERAPEUTIC CHALLENGES POTENTIAL SOLUTION Systemic toxicity issues may limit daily dosage of UC drugs Reduced systemic uptake is designed to reduce toxicity and adverse events Difficulty of a
Slide 8: Research Data Supports Targeted Approach
RESEARCH DATA SUPPORTS TARGETED APPROACH Tissue drug concentration correlates with endoscopic outcomes in UC Verstockt B, Alsoud D, van Oostrom J, et al. Tofacitinib tissue exposure correlates with endoscopic outcome. Poster presented at: 17th Congress of the European Crohn’s and Colitis Organisatio
Slide 9: Targeted Therapeutic Delivery for IBD
TARGETED THERAPEUTIC DELIVERY FOR IBD Needle-free, oral drug delivery to the colon ORAL ADMINISTRATION Convenient oral capsule the size of a fish oil pill TARGETED THERAPEUTICS 1. Biora Therapeutics internal data AUTONOMOUS LOCATION Proprietary autolocation in the GI tract for accurate drug delivery
Slide 10: Device Function Studies
DEVICE FUNCTION STUDIES Demonstrated accurate localization and delivery to colon Biora Therapeutics internal data ACCURATE LOCALIZATION AND DELIVERY TO HUMAN COLON Clinical device validation for localization and delivery function using scintigraphic imaging in normal, healthy volunteers Achieved dis
Slide 11: Device Function Studies: Three Successful Human Studies
Biora Therapeutics internal data DEVICE FUNCTION STUDIES Three successful human studies show device functions with and without food, and in active UC patients TARGETED THERAPEUTICS PM-601 Device Function Study in Healthy Volunteers – Fasted State PM-611 Device Function Study in Healthy Volunteers –
Slide 12: PGN-600 Preclinical Tox Study Results
PGN-600 PRECLINICAL TOX STUDY RESULTS Reduced systemic uptake, better PK effect and coverage Biora Therapeutics internal data RESULTS Non-GLP tox study; 7 days/QD in canine model compared PGN-600 (tofacitinib 10mg liquid formulation delivered via DDS capsule) vs. standard oral tablet (tofacitinib 10
Slide 13: PGN-600 Clinical Development Plan
PGN-600 (TOFACITINIB + DDS DEVICE) Clinical Development Plan Q4 2022 Q1 2023 Q2 2023 Q3 2023 Q4 2023 14-DAY GLP TOX STUDY 56-DAY GLP TOX STUDY TARGETED THERAPEUTICS INTERIM DATA Preclinical / IND enabling Clinical FINAL DATA 2 weeks/QD 8 weeks/QD Design: SAD/MAD Primary endpoint Safety & tolerabilit
Slide 14: Phase 1: Single and Multiple Ascending Dose Studies
PHASE 1: SINGLE AND MULTIPLE ASCENDING DOSE STUDIES Evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of PGN-600 in healthy volunteers SAD 24 subjects MAD 24 subjects D7 Blood Stool D1 Blood Stool D2 Blood Stool D3 Blood Stool PGN-600 Baseline D1 Blood Stool D2 Blood Stool D3 Bloo
Slide 15: Ulcerative Colitis: Treatment Landscape
Source: Evaluate Pharma; GlobalData Global annual sales forecast for ulcerative colitis therapeutics: $7 billion in 20221 >10 FDA-approved drugs for UC ULCERATIVE COLITIS: TREATMENT LANDSCAPE Potential for market-leading efficacy in tofacitinib creates sizeable opportunity Vedolizumab Adalimumab Ust
Slide 16: Systemic Therapeutics
OOO SYSTEMIC THERAPEUTICS
Slide 17: Unmet Need: Needles and Poor Disease Management
UNMET NEED Needles are associated with poor disease management Frost & Sullivan research commissioned by Rani Therapeutics Holdings, Inc. https://ir.ranitherapeutics.com/static-files/b1f080bf-a860-4136-87cb-d6f7c49c1502 Spain CV, Wright JJ, Hahn RM, Wivel A, Martin AA. Self-reported Barriers to Adhe
Slide 18: Oral Biotherapeutics Delivery System
ORAL BIOTHERAPEUTICS DELIVERY SYSTEM Needle-free, oral delivery to small intestine ORAL CAPSULE Convenient oral capsule the size of a multivitamin for ease of swallowing PRECISE DELIVERY Enteric trigger for precise timing of drug delivery to the small intestine NEEDLE-FREE ADMINISTRATION Liquid jet
Slide 19: PGN-OB1 Preclinical Performance
Biora Therapeutics internal data See also Lee SN, Stork C, Smith J, et al. Assessing the performance of an oral biotherapeutic delivery system (OBDS) using intra-duodenal endoscopy delivery in Yucatan minipigs. Poster presented at: Controlled Release Society Annual Meeting, July 13-14, 2022, Montrea
Slide 20: Development Timeline
DEVELOPMENT TIMELINE
Slide 21: Development Timeline
DEVELOPMENT TIMELINE PROGRAM Q3 2022 Q4 2022 Q1 2023 Q2 2023 Q3 2023 Q4 2023 MILESTONES/CATALYSTS TARGETED THERAPEUTICS Establish device performance in UC patients Preclinical toxicology to support phase 1 and phase 2 study Evaluate the safety & tolerability, PK/PD of PGN-600 subject to FDA review S
Slide 22: Appendix
APPENDIX
Slide 23: Targeted Therapeutics Publications
TARGETED THERAPEUTICS PUBLICATIONS bioratherapeutics.com/publications Development of targeted therapeutic antibodies for the treatment of inflammatory bowel disease: A proof of concept. Presented at DDW 2019. A comparison of systemic versus targeted anti-TNFα antibody in treatment of colitis induced
Slide 24: Systemic Therapeutics Publications
SYSTEMIC THERAPEUTICS PUBLICATIONS bioratherapeutics.com/publications SYSTEMIC THERAPEUTICS Development of ex-vivo and in-vivo models to assess the performance of an oral biotherapeutic delivery system (OBDS) capsule. Poster presented at: Controlled Release Society Annual Meeting, July 13-14, 2022,
Slide 25: Intellectual Property Portfolio
SAMPLING & DIAGNOSTICS 17 patent families covering: GI sample preservation GI analyte detection & quantification systems Complementary diagnostic markers Protein and nucleic acid markers & assays THERAPEUTICS 28 patent families covering: Treatment via ingestible device GI delivery PK/PD profiles GI
Slide 26: IORA
IORA herapeutics
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