Biora Therapeutics, Inc. · OTC:BIORQ
Biora Therapeutics — Investor Presentation (May 2022)
20 slides from Biora Therapeutics's investor presentation, May 10, 2022
Slide 1: Corporate Presentation May 2022
CORPORATE PRESENTATION May 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: What We Do
WHAT WE DO Developing innovative oral biotherapeutics for gastrointestinal health and beyond TARGETED THERAPEUTICS SYSTEMIC THERAPEUTICS PGN-001 Adalimumab variant + DDS OBDS Systemic Oral Biotherapeutics Delivery System DDS Targeted Drug Delivery System PGN-600 Tofacitinib + DDS Capsule technology
Slide 4: Therapeutics Pipeline
THERAPEUTICS PIPELINE PROGRAM PROGRAM INDICATION DESIGN/FEASIBILITY PRECLINICAL CLINICAL TARGETED THERAPEUTICS DDS IBD PGN-600 Ulcerative Colitis PGN-001 Ulcerative Colitis SYSTEMIC THERAPEUTICS OBDS – PGN-OB1 Autoimmune PGN-OB2 Diabetes – Undisclosed – Undisclosed – Undisclosed GLP-1 agonist + Devi
Slide 5: Targeted Therapeutics
OOO TARGETED THERAPEUTICS
Slide 6: Ulcerative Colitis: The Treatment Gap
ULCERATIVE COLITIS: THE TREATMENT GAP Despite advanced 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)
Slide 7: Targeted Therapeutics: A Potential Solution for Unmet Need in UC
TARGETED THERAPEUTICS: A POTENTIAL SOLUTION FOR UNMET NEED IN UC Verstockt B, Alsoud D, van Oostrom J, et al. Tofacitinib tissue exposure correlates with endoscopic outcome. Oral presentation at the 34th edition of the Belgian Week of Gastroenterology, February 9, 2022. Alsoud D, Verstockt B, Fiocch
Slide 8: Our IBD Solution: Targeted Therapeutics
OUR IBD SOLUTION: TARGETED THERAPEUTICS Targeted drug delivery to the GI tract designed to improve efficacy and safety Targeted delivery designed to improve endoscopic outcomes by increasing drug levels at the site of disease Payload delivery method designed to minimize systemic uptake, potentially
Slide 9: Targeted Therapeutics: Preclinical Results
TARGETED THERAPEUTICS: PRECLINICAL RESULTS Pharmacokinetic data from two marker drugs administered in canine model indicated: Successful delivery to colon via DDS No early release of drug No drug absorption in upper GI tract Standard oral dose vs. PGN-600 (tofacitinib delivered via DDS capsule) in c
Slide 10: Targeted Therapeutics: Clinical Device Performance
TARGETED THERAPEUTICS: CLINICAL DEVICE PERFORMANCE Accurate localization and delivery demonstrated in humans Successful clinical device validation for localization and delivery function using scintigraphic imaging: Safety and tolerability in normal healthy volunteers; devices recovered intact 83% ac
Slide 11: Targeted Delivery: Superior Pharmacodynamics in Multiple Molecules
Anti-TNFa in animal models TARGETED DELIVERY: SUPERIOR PHARMACODYNAMICS IN MULTIPLE MOLECULES Systemic delivery via intraperitoneal injection (IP) vs. targeted intracecal delivery (IC) of anti-TNFα in mouse model of T-cell transfer colitis demonstrated: Significantly improved histopathology score vs
Slide 12: Targeted Therapeutics Clinical Plan
TARGETED THERAPEUTICS CLINICAL PLAN FUNCTION STUDIES TOX STUDY PHASE 1 CLINICAL STUDIES PHASE 1B/2A CLINICAL STUDIES PM-601 Device Function Study in Normal Healthy Volunteers Device was well tolerated Achieved pan-colon distribution of payload Accurately identified entry into the colon (10/12); no e
Slide 13: Systemic Therapeutics
OOO SYSTEMIC THERAPEUTICS
Slide 14: Patients Prefer Oral Delivery of Medication
Patients prefer oral delivery of medication NEEDLE AVERSION LEADS TO POOR PATIENT ADHERENCE Wright S, Yelland M, Heathcote K, Ng SK, Wright G. Fear of needles--nature and prevalence in general practice. Aust Fam Physician. 2009;38(3):172-176. Spain CV, Wright JJ, Hahn RM, Wivel A, Martin AA. Self-re
Slide 15: Systemic Therapeutics Delivery System
x SYSTEMIC THERAPEUTICS DELIVERY SYSTEM Needle-free, oral delivery to small intestine designed for optimal systemic uptake Needle-free, liquid jet administration to intestinal tissue for enhanced systemic uptake More frequent administration vs. injection may improve outcomes Versatile platform can d
Slide 16: Systemic Therapeutics: Precision Delivery
SYSTEMIC THERAPEUTICS: PRECISION DELIVERY Preclinical studies demonstrate precise and reliable release of payload ACCURATE DELIVERY IN SMALL INTESTINE STUDY DESIGN RESULTS Capsule loaded with a radio-opaque marker (iohexal) Two different enteric triggers evaluated Sequential imaging as the capsule t
Slide 17: Demonstrated up to 67% Bioavailability for Monoclonal Antibodies
Demonstrated up to 67% bioavailability for monoclonal antibodies EXCELLENT SYSTEMIC UPTAKE FOR ORALLY DELIVERED LARGE MOLECULES Biora Therapeutics internal data Multiple studies in swine model with endoscopically placed, autonomous device compared to IV administration Achieved up to 67% bioavailabil
Slide 18: Milestones & Corporate Highlights
MILESTONES & CORPORATE HIGHLIGHTS
Slide 19: Development Timeline
DEVELOPMENT TIMELINE PROGRAM PROGRAM Q1 2022 Q2 2022 Q3 2022 Q4 2022 H1 2023 ENABLES TARGETED THERAPEUTICS PM-611 PM-602 Establishes device performance in healthy volunteers & UC patients PRECLINICAL TOXOLOGY Preclinical toxicology to support phase 1b/2a study PHASE 1 CLINICAL TRIAL Evaluate the saf
Slide 20: Biora Therapeutics
IORA herapeutics
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