Biora Therapeutics, Inc. · OTC:BIORQ
Biora Therapeutics — Investor Presentation (March 2023)
29 slides from Biora Therapeutics's investor presentation, Mar 30, 2023
Slide 1: Corporate Presentation March 2023
CORPORATE PRESENTATION March 2023 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
Treatment at the site of disease in the GI tract could improve outcomes for patients with inflammatory bowel disease Our mission is to reimagine therapeutic delivery Needle-free, oral delivery of large molecules designed to replace injection for better management of chronic diseases Innovating smart
Slide 4: Therapeutic Pipeline
THERAPEUTIC PIPELINE PROGRAM PROGRAM INDICATION DESIGN/FEASIBILITY PRECLINICAL CLINICAL TARGETED THERAPEUTICS NaviCap™ Targeted Oral Delivery Platform -- BT-600 NaviCap + tofacitinib UC BT-001 NaviCap + adalimumab variant UC SYSTEMIC THERAPEUTICS BioJet™ Systemic Oral Delivery Platform -- BT-200 Bio
Slide 5: Targeted Oral Delivery Platform
TARGETED ORAL DELIVERY PLATFORM
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: NaviCap Targeted Drug Delivery Platform
NAVICAP™ TARGETED DRUG DELIVERY PLATFORM Needle-free, oral drug delivery to the colon ORAL ADMINISTRATION Convenient oral capsule the size of a fish-oil pill 1. Lee SN, Razag G, Stork C, et al. Potential effects of food on a novel Drug Delivery System (DDS) to deliver therapeutic compound into the c
Slide 10: NaviCap: Autonomous Location and Delivery to the Colon
https://biora.wistia.com/medias/r65935rbqs NAVICAP™ TARGETED DRUG DELIVERY PLATFORM Autonomous location and delivery to the colon
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 (Fed State and Healthy Volunteers)
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: BT-600 Preclinical Study Results
BT-600 (NAVICAP™ + TOFACITINIB) 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 BT-600 (tofacitinib 10mg liquid formulation delivered via device) vs. standard oral tablet (tofa
Slide 14: BT-600 Clinical Development Plan
BT-600 (NAVICAP™ + TOFACITINIB) Clinical Development Plan H1 2023 H2 2023 H1 2024 14-DAY GLP TOX STUDY INTERIM DATA Preclinical / IND enabling Clinical FINAL DATA 2 weeks/QD Design: SAD/MAD Primary endpoint Safety & tolerability Key secondary endpoints PK/PD IND FILING & PHASE 1 IN HEALTHY VOLUNTEER
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 BT-600 in healthy volunteers SAD 24 subjects MAD 24 subjects D7 Blood Stool D1 Blood Stool D2 Blood Stool D3 Blood Stool BT-600 Baseline D1 Blood Stool D2 Blood Stool D3 Blood
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 Oral Delivery Platform
SYSTEMIC ORAL DELIVERY PLATFORM
Slide 18: 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 19: BioJet Systemic Drug Delivery Platform
BIOJET™ SYSTEMIC DRUG DELIVERY PLATFORM 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 j
Slide 20: BioJet: Liquid Jet Delivery to the Small Intestine
https://biora.wistia.com/medias/embr15eh3a BIOJET™ SYSTEMIC DRUG DELIVERY PLATFORM Liquid jet delivery to the small intestine
Slide 21: BT-200 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. Novo Nordisk A/S. Rybels
Slide 22: Next-Generation Device Preclinical Results
Biora Therapeutics preclinical studies in porcine model with endoscopically placed and activated next-generation device to evaluate device function. Internal data, pending presentation of results at upcoming conference(s). Bioavailability target of 15% set by Biora Therapeutics and pharma collaborat
Slide 23: Development Timeline: Systemic Therapeutics Platform Milestones
DEVELOPMENT TIMELINE Systemic Therapeutics Platform Milestones 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-grade device with next-gen
Slide 24: Upcoming Milestones and Mission
Completing tox study analysis Preparing to file IND and enter the clinic Our mission is to reimagine therapeutic delivery Completing development of next-generation device Progressing pharma collaborations Innovating smart capsule technologies to deliver the right dose to the right place, safely TARG
Slide 25: Appendix
APPENDIX
Slide 26: 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 27: BioJet Systemic Drug Delivery Platform Publications
BIOJET™ SYSTEMIC DRUG DELIVERY PLATFORM bioratherapeutics.com/publications 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, 2022 and at the Amer
Slide 28: Intellectual Property Portfolio
SAMPLING & DIAGNOSTICS 6 patent families covering: GI sample preservation GI analyte detection & quantification systems Complementary diagnostic markers THERAPEUTICS 26 patent families covering: Treatment via ingestible device GI delivery PK/PD profiles GI delivery dosing regimens GI delivery drug c
Slide 29: Biora Therapeutics
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