Biora Therapeutics, Inc. · OTC:BIORQ
Biora Therapeutics — Investor Presentation (November 2022)
28 slides from Biora Therapeutics's investor presentation, Nov 14, 2022
Slide 1: Corporate Presentation November 2022
CORPORATE PRESENTATION November 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: Our mission is to reimagine therapeutic delivery
Our mission is to reimagine therapeutic 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 technology designed to enable needle-fr
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 variant + Device UC SYSTEMIC THERAPEUTICS OBDS Device -- PGN-OB2 GLP-1 agonist + Device Diabetes PGN-OB1 Adalimumab variant +
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: Autonomous location and delivery to the colon
https://biora.wistia.com/medias/r65935rbqs TARGETED THERAPEUTIC DELIVERY FOR IBD Autonomous location and delivery to the colon TARGETED THERAPEUTICS
Slide 11: 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 patients with active ulcerative colitis
Slide 12: Device Function Studies: Three Successful Studies
Lee SN, Sandefer E, Doll W, et al. A Scintigraphic Study to Evaluate the Safety, Tolerability, and Functionality of a Drug Delivery System (DDS) Device in Healthy Volunteers in Fasted State. Poster presented at: American College of Gastroenterology Annual Scientific Meeting, October 21-26, 2022, Cha
Slide 13: PGN-600 Preclinical Study Results
PGN-600 PRECLINICAL STUDY RESULTS Reduced systemic uptake, better PK effect and coverage Biora Therapeutics internal data RESULTS Non-GLP study; 7 days/QD in canine model compared PGN-600 (tofacitinib 10mg liquid formulation delivered via DDS capsule) vs. standard oral tablet (tofacitinib 10mg) Redu
Slide 14: PGN-600 Clinical Development Plan
PGN-600 (TOFACITINIB + DDS DEVICE) Clinical Development Plan 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 & tolerability Key se
Slide 15: 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 16: 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 17: Systemic Therapeutics
OOO SYSTEMIC THERAPEUTICS
Slide 18: Unmet Need: Needles are associated with 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 19: 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 20: Liquid jet delivery to the small intestine
https://biora.wistia.com/medias/embr15eh3a ORAL BIOTHERAPEUTICS DELIVERY SYSTEM Liquid jet delivery to the small intestine SYSTEMIC THERAPEUTICS
Slide 21: PGN-OB1 Preclinical Performance
Lee SN, Stork C, Smith J, et al. Development of a submucosal injection device for an oral biotherapeutic delivery system. Poster presented at: Parenteral Drug Association Universe of Pre-Filled Syringes and Injection Devices Conference, October 18-19, 2022, Palm Springs, CA. Rybelsus® oral Semagluti
Slide 22: Development Timeline: Systemic Therapeutics Platform Milestones
DEVELOPMENT TIMELINE Systemic Therapeutics Platform Milestones SYSTEMIC THERAPEUTICS H1 2022 H2 2022 H1 2023 H2 2023 MILESTONES/CATALYSTS Successfully confirmed viability of platform with research-grade device Incorporating updated medical-grade components Intent to replicate data from research-grad
Slide 23: Reimagining therapeutic delivery
Reimagining therapeutic delivery TARGETED THERAPEUTICS Clinical-ready device Entering the clinic SYSTEMIC THERAPEUTICS Refining preclinical models Data generation and partnership
Slide 24: Appendix
APPENDIX
Slide 25: 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. Poster presented at DDW 2019. A comparison of systemic versus targeted anti-TNFα antibody in treatment of colitis
Slide 26: 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 the Controlled Release Society Annual Meeting, July 13-14, 202
Slide 27: Intellectual Property Portfolio
SAMPLING & DIAGNOSTICS 10 patent families covering: GI sample preservation GI analyte detection & quantification systems Complementary diagnostic markers Protein and nucleic acid markers & assays THERAPEUTICS 25 patent families covering: Treatment via ingestible device GI delivery PK/PD profiles GI
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