Biora Therapeutics, Inc. · OTC:BIORQ
Biora Therapeutics — Investor Presentation (July 2024)
31 slides from Biora Therapeutics's investor presentation, Jul 1, 2024
Slide 1: Corporate Presentation July 2024
CORPORATE PRESENTATION July 2024
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: Innovating smart pill technologies to deliver the right dose to the right place
Innovating smart pill technologies to deliver the right dose to the right place, safely. Treatment at the site of disease in the GI tract Needle-free, oral delivery of large molecules could improve outcomes for patients with designed to replace injection for better inflammatory bowel disease managem
Slide 4: Therapeutic Pipeline
THERAPEUTIC PIPELINE NAVICAP PROGRAMS DRUG DESIGN/FEASIBILITY PRECLINICAL CLINICAL NaviCa Targeted Oral Delivery Platform — BT-600 in ulcerative colitis tofacitinib* adalimumab BT-001 in ulcerative colitis variant* BIOJ PROGRAMS DRUG DESIGN/FEASIBILITY PRECLINICAL CLINICAL BioJe Systemic Oral Delive
Slide 5: NaviCap Targeted Oral Delivery
NAVIcap” TARGETED ORAL DELIVERY
Slide 6: Clinical presentation of ulcerative colitis
Clinical presentation of ulcerative colitis E1: PROCTITIS E2: DISTAL COLITIS E1: PANCOLITIS SYMPTOMS SYMPTOMS SYMPTOMS Rectal bleeding, E1 plus diarrhea, E2 plus constitutional tenesmus, urgency abdominal cramping symptoms (fatigue, fever) 30-60% of patients 16-45% of patients 15-35% of patients © 2
Slide 7: Ulcerative Colitis: The Treatment Gap
ULCERATIVE COLITIS: THE TREATMENT GAP Despite therapeutics targeting different pathways, few patients achieve long-term remission UC TREATMENT CYCLE ABOUT ULCERATIVE Treatment drug therapy begins to reach with therapeutic 2-3 months of COLITIS levels 15-30% of patients achieve remission of symptoms
Slide 8: Unmet Need in Ulcerative Colitis
UNMET NEED IN ULCERATIVE COLITIS Anatomically targeted delivery could enable rapid induction and improve patient response THERAPEUTIC CHALLENGES POTENTIAL SOLUTION Localized delivery could increase drug Difficulty of achieving sufficient 1 activity at the site of disease, which is drug activity at s
Slide 9: NaviCap Targeted Oral Delivery Platform
NAVICAP TARGETED ORAL DELIVERY PLATFORM Needle-free, oral drug delivery to the colon ORAL ADMINISTRATION Convenient oral capsule the size of a fish-oil pill AUTONOMOUS LOCATION GITr autolocation technology enables targeted delivery to the colon, regardless of fasted or fed state1 TARGETED DRUG DELIV
Slide 10: Autonomous location and delivery to the colon
Autonomous location and delivery to the colon https://biora.wistia.com/medias/r65935rbqs 10 © 2024 Biora Therapeutics, Inc. All rights reserved.
Slide 11: Device Function Studies (Without Drug)
DEVICE FUNCTION STUDIES (WITHOUT DRUG) Four successful studies in humans showing the NaviCa device was well tolerated and performed as intended Q4 2022 Q4 2022 Q1 2023 Q2 2023 PM-601 Device Function PM-602 Device Function PM-611 Device Function BT-603 Device Function Study in Healthy Study in Patien
Slide 12: Scintigraphic imaging of NaviCap delivery in healthy participant
DEVICE FUNCTION STUDIES (WITHOUT DRUG) Scintigraphic imaging of NaviCap delivery in healthy participant Despite variability in the GI environment among participants, the NaviCap device has been observed to perform as designed across a range of expected differences in motility. https://www.biorathera
Slide 13: Phase 1 Clinical Trial Design
PHASE 1 CLINICAL TRIAL DESIGN Evaluate safety, tolerability, and pharmacokinetics of BT-600 in healthy participants Placebo or BT-600 10mg n=9 Placebo n=3 SAD 5mg n=9 Baseline D1 D2 D3 D8 Blood Blood Blood Blood 24 subjects Placebo n=3 Stool Stool Stool Placebo or BT-600, 7 days/QD 10mg 7x QD n=9 Pl
Slide 14: Interim Analysis: Single Ascending Dose in Healthy Participants
PHASE 1 INTERIM ANALYSIS: SINGLE ASCENDING DOSE IN HEALTHY PARTICIPANTS Pharmacokinetic profile consistent with anatomically targeted delivery in the colon MEAN PLASMA TOFACITINIB CONCENTRATION • First evidence of systemic absorption at ~6 hours, FOLLOWING ADMINISTRATION OF A SINGLE consistent with
Slide 15: Phase 1 SAD/MAD: Topline Results
PHASE 1 SAD/MAD: TOPLINE RESULTS All trial objectives met; Demonstrated drug delivery to the colon PLASMA Achieved PK profile • Tofacitinib first detected in blood at ~6 hours, consistent with colonic delivery PHARMACOKINETICS (PK) consistent with drug • Maximal blood levels were 3–4 times lower tha
Slide 16: BT-600 in Ulcerative Colitis Clinical Development Plan
BT-600 in ULCERATIVE COLITIS Clinical development plan RANDOMIZED, PLACEBO CONTROLLED, BLINDED CLINICAL TRIALS PHASE 1 PHASE 1b PHASE 2 Purpose Purpose Purpose Provide evidence of NaviCap colonic Confirm PK profile in UC patients; Proof of concept: efficacy of tofacitinib delivery of a therapeutic i
Slide 17: UC Market Size and Share
UC MARKET SIZE AND SHARE NaviCap could optimize delivery of IBD therapies, enabling drugs to act at site of disease and improve outcomes • Across established UC therapies, drug UC ADVANCED THERAPEUTICS activity at the site of disease is known to 5 FORECASTED GLOBAL MARKET SHARE BY DRUG CLASS correla
Slide 18: BioJet Systemic Oral Delivery
BlOjet” SYSTEMIC ORAL DELIVERY
Slide 19: Case Study: Unmet need in peptide delivery for treatment of diabetes
CASE STUDY Unmet need in peptide delivery for treatment of diabetes of people with diabetes discontinue 38% injectable medications due to injection concerns1,2 of patients fail to maintain diabetes treatment 42% due to injection concerns when using an injectable GLP-1 agonist2 higher discontinuation
Slide 20: BioJet Systemic Oral Delivery Platform
BIOJ SYSTEMIC ORAL DELIVERY PLATFORM Needle-free, oral delivery to small intestine PRECISE DELIVERY • Enteric trigger for precise timing of drug delivery to the small intestine • Potential to enable liver-targeted delivery UNIQUE SOLUTION • Uses existing liquid formulations, without complex reformul
Slide 21: Liquid jet delivery to the small intestine
Liquid jet delivery to the small intestine https://biora.wistia.com/medias/embr15eh3a 21 © 2024 Biora Therapeutics, Inc. All rights reserved.
Slide 22: Pharmacokinetics of semaglutide delivered via BioJet in a porcine model
Pharmacokinetics of semaglutide delivered via the BioJ device in a porcine model SYSTEMIC EXPOSURE TO SEMAGLUTIDE FOLLOWING AUTONOMOUS TRIGGERING OF BIOJET DEVICE ACROSS MULTIPLE STUDIES 10000 • Multiple studies performed in swine across IV different animal colonies 1000 PSS3/4/5 IV administration o
Slide 23: Pharmacokinetics of BT-001 (adalimumab variant) via BioJet in a porcine model
Pharmacokinetics of BT-001 (adalimumab variant) delivered via the BioJ device in a porcine model SYSTEMIC EXPOSURE TO ADALIMUMAB FOLLOWING AUTONOMOUS TRIGGERING OF BIOJET DEVICE IV • Mean bioavailability >30% shown with newer 100000 device configurations across multiple studies ID-X022 ng/mL 10000 •
Slide 24: Needle-free, liquid jet delivery of biomolecules
Needle-free, liquid jet delivery of biomolecules CATEGORY-LEADING BROAD APPLICABILITY NOVEL DRUG DELIVERY BIOAVAILABILITY • Platform technology proven TECHNOLOGY • Liquid jet delivery to the small to deliver multiple molecule • Possesses comprehensive intestine designed to classes patent protection
Slide 25: Preclinical Results
PRECLINICAL RESULTS Demonstrated bioavailability across multiple molecules Preclinical studies in swine model with endoscopically placed and autonomously triggered BioJet device MOLECULE TYPE DRUG ORAL RESEARCH COLLABORATIONS BIOAVAILABILITY Ionis adalimumab ANTIBODY (monoclonal antibody) over 40% m
Slide 26: Innovating smart pill technologies to deliver the right dose to the right place
Innovating smart pill technologies to deliver the right dose to the right place, safely. • Clinical trial completed • Tested in animals with multiple molecule classes, • Anticipating final SAD/MAD data in Q2 including peptides, ASOs, antibodies • Progressing toward partnerships 26 © 2024 Biora Thera
Slide 27: Appendix
APPENDIX
Slide 28: Intellectual Property
INTELLECTUAL PROPERTY Diverse patent portfolio with 73 distinct patent families Approximately 190 granted patents and 136 pending applications in major countries and regions around the world NaviC Platform BioJe Platform Other Device & Diagnostic IP 30 patent families covering: 7 patent families cov
Slide 29: Publications: NaviCap targeted oral delivery platform
PUBLICATIONS NaviCa targeted oral delivery platform 1. Development of targeted therapeutic antibodies for the treatment of inflammatory bowel disease: A proof of concept. Poster presented at DDW 2019. 2. A comparison of systemic versus targeted anti-TNFα antibody in treatment of colitis induced by
Slide 30: Publications: BioJet systemic oral delivery platform
PUBLICATIONS BioJ systemic oral delivery platform 1. 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 American College of Gastro
Slide 31: Biora Therapeutics
es ¢) BIORA Therapeutics
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