Slide 1: Unmet Needs in Ulcerative Colitis; BT-600 Phase 1 Trial Results
Exhibit 99.2 UNMET NEEDS IN ULCERATIVE COLITIS BT-600 PHASE 1 TRIAL RESULTS July 17, 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: Unmet Needs in Ulcerative Colitis
UNMET NEEDS IN ULCERATIVE COLITIS Bruce E. Sands, MD, MS Chief of the Dr. Henry D. Janowitz Division of Gastroenterology Dr. Burrill B. Crohn Professor of Medicine Icahn School of Medicine at Mount Sinai Mount Sinai Hospital, New York
Slide 4: 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 4 ©
Slide 5: UC histology findings
UC histology findings Normal colon Inactive chronic colitis Mildly active chronic colitis crypt branching and dilation (arrows) neutrophilic infiltrate in lamina propria and epithelium (arrows) Moderately active chronic colitis Severely active chronic colitis neutrophilic and lymphoplasmacytic infil
Slide 6: UC has high impact on patient lives
UC has high impact on patient lives ≈1.5 million patients with UC in the United States PATIENTS WHO FELT THEIR CONDITION PSYCHOLOGICAL IMPACT OF UC WAS CONTROLLING THEIR LIVES 84% 82% 70% 62% 53%* 44% 37% 19% UC Asthma Migraine RA Worry about Making life more Feel Sometimes or (n=451) (n=305) (n=305
Slide 7: Therapeutic gap in UC
Therapeutic gap in UC INDUCTION OF CLINICAL REMISSION IN UC 7 1. 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. doi:10.1016/S2468-1253(21)00065-0 © 2024 Biora Therapeutics, Inc
Slide 8: Unmet need in ulcerative colitis
UNMET NEED IN ULCERATIVE COLITIS Anatomically targeted, topical delivery could improve efficacy and patient outcomes THERAPEUTIC CHALLENGES POTENTIAL SOLUTION Localized delivery could increase drug Difficulty of achieving sufficient activity at the site of disease, which is 1 drug activity at site o
Slide 9: NaviCap targeted oral delivery
NAVICAP TARGETED ORAL DELIVERY Anatomically targeted, topical drug delivery to the colon CONVENTIONAL NAVICAP DIRECT ORAL DELIVERY DELIVERY TO COLON BLOOD TO TISSUE LUMEN TO TISSUE TO BLOOD • Drug is absorbed in the • Achieves tissue exposure through topical delivery to colon upper GI tract and deli
Slide 10: BT-600 Phase 1 Clinical Trial in Healthy Participants
BT-600 PHASE 1 CLINICAL TRIAL IN HEALTHY PARTICIPANTS Ariella Kelman, MD Chief Medical Officer Biora Therapeutics
Slide 11: 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 GITrac autolocation technology enables targeted delivery to the colon, 1 regardless of fasted or fed state TARGETED DRUG DE
Slide 12: Clinical trial design
PHASE 1 CLINICAL TRIAL DESIGN Evaluate safety and pharmacokinetics of BT-600 (NaviCap + tofacitinib proprietary liquid formulation) in healthy participants Placebo or BT-600 10mg n=9 Placebo n=3 D2 D8 Baseline D1 D3 5mg n=9 SAD Blood Blood Blood Blood n=3 Placebo Stool Stool Stool 24 subjects Placeb
Slide 13: SAD/MAD: Topline results
PHASE 1 SAD/MAD: TOPLINE RESULTS All trial objectives met; Precise drug delivery to the colon with limited systemic exposure • Tofacitinib first detected in blood at ≈6 hours, consistent with colonic delivery PLASMA Achieved PK profile PHARMACOKINETICS (PK) 1 consistent with drug • Maximal blood lev
Slide 14: NaviCap device performance
PHASE 1 NAVICAP DEVICE PERFORMANCE Consistent drug release in the colon, bypassing the upper GI tract • >95% of devices successfully detected colon entry • No early drug release before colon entry • Tight correlation between software device function and PK results 1 • Data consistent with those prev
Slide 15: SAD: PK results
PHASE 1 SAD: PK RESULTS PK profile confirms lower systemic levels with 3–4x lower Cmax than Xeljanz XELJANZ: MEAN PLASMA DRUG CONCENTRATION BT-600: MEAN PLASMA DRUG CONCENTRATION 2 1 FOLLOWING ADMINISTRATION OF SINGLE ORAL DOSES FOLLOWING ADMINISTRATION OF SINGLE ORAL DOSES Time after dose (hr) 1. P
Slide 16: MAD: PK results
PHASE 1 MAD: PK RESULTS MAD PK confirms colonic delivery and low systemic exposure BT-600 † 1 PK Parameters Multiple Oral Dosing XELJANZ (n=9) DAY 1 DAY 7 5 mg 10 mg 5 mg 10 mg 5 mg 10 mg Dosing Regimen 2 3 Once Daily Once Daily Once Daily Once Daily Twice Daily Single Dose 8 6 T hours N/A N/A NR NR
Slide 17: MAD: PK results
PHASE 1 MAD: PK RESULTS Consistent PK profile with repeat dosing Characteristic, single-subject concentration time curve • Dose dependent, low systemic exposure • Consistent with colonic delivery 5 mg, QD BT-600 x7 days 10 mg, BT-600 x 7 days 50 C max 40 BT-600 5 mg QD x 7 days 30 BT-600 10 mg QD x
Slide 18: MAD: BT-600 evidence of drug delivery across distal biopsy sites
PHASE 1 MAD: BT-600 Evidence of drug delivery across all distal biopsy sites PLASMA CONCENTRATION PROFILE BIOPSY SITES FOR FINAL DOSE (DAY 7) Serum BT-001 Concentration, Subject 2021 20 SPLENIC FLEXURE C max tofacitinib present in 15 15/18 biopsies 10 DESCENDING 5 COLON tofacitinib present in 0 15/1
Slide 19: MAD: Colon tissue exposure
PHASE 1 MAD: COLON TISSUE EXPOSURE Good correlation between tissue and plasma levels SPLENIC FLEXURE DESCENDING COLON SIGMOID COLON • Plasma levels determined at 20 hours after final dose, while tissue biopsies were obtained at 24 ±2 hours after final dose • Mean tissue concentrations above IC50 acr
Slide 20: MAD: Projected tofacitinib levels above IC90
PHASE 1 MAD: COLON TISSUE EXPOSURE Projected tofacitinib levels above IC90 through at least 16 hours CONVENTIONAL ORAL TOFACITINIB NAVICAP-DELIVERED TOFACITINIB CONCENTRATIONS 1 2 CONCENTRATIONS (DOSE 10MG BID) (BT-600 5MG QD AND 10 MG QD) † Colon Tissue Concentration Plasma Hours Splenic Descending
Slide 21: Safety parameters
PHASE 1: SAFETY PARAMETERS BT-600 was well tolerated • All AEs were mild and consistent with those expected in healthy population (headache, constipation) • No evidence of device or drug colon toxicity; colon tissue histology within normal limits • No notable changes or differences in safety laborat
Slide 22: BT-600 in ulcerative colitis
BT-600 IN ULCERATIVE COLITIS Phase 1 trial results support clinical development plan 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 inform Ph2 dose selection d
Slide 23: Considerations for Colonic Delivery in UC
CONSIDERATIONS FOR COLONIC DELIVERY IN UC Brian Feagan, MD, FRCPC Professor of Medicine Schulich School of Medicine & Dentistry University of Western Ontario Gastroenterologist London Health Sciences Centre, Ontario Sr. Scientific Director Alimentiv, Inc.
Slide 24: Topical treatments can be effective in UC, but challenging to deliver
Topical treatments can be effective in UC, but challenging to deliver Previous approaches to topical treatment include enemas, rectal foams, suppositories, and oral delayed-release preparations • 5-Aminosalicylates, corticosteroid preparations in mild to moderate disease • Calcineurin inhibitor enem
Slide 25: Challenges with existing colonic delivery
Challenges with existing colonic delivery RECTAL PREPARATIONS COLONIC DELIVERY ORAL FORMULATIONS SHOW POOR COLONIC DISTRIBUTION • Associated with poor retention 2 IN UC PATIENTS • Cannot reach proximal colon • Can be embarrassing for patients EXISTING COLONIC DELIVERY ORAL CAPSULES • pH-sensitive po
Slide 26: Colon tissue drug exposure correlates with endoscopic outcomes
Colon tissue drug exposure and activity correlates with endoscopic outcomes 1 p = 0.04 TOFACITINIB TISSUE EXPOSURE HIGHER IN RESPONDERS 30 UC patients with active endoscopic disease Tx with XELJANZ (tofacitinib) and prospectively monitored • Higher tofacitinib tissue exposure was associated with end
Slide 27: MAD: Colon tissue exposure, higher tissue to plasma ratio
PHASE 1 MAD: COLON TISSUE EXPOSURE NaviCap colonic delivery achieves higher tissue to plasma concentration ratio at lower dose CONVENTIONAL TOFACITINIB BT-600 DESCENDING COLON BT-600 SIGMOID COLON 2 1 2 10 MG BID 5 MG AND 10 MG QD 5 MG AND 10 MG QD 10 ng/mL: 4705 ng/g 10 ng/mL: 393 ng/g 10 ng/mL: 30
Slide 28: Key goals for successful topical colonic delivery
Key goals for successful topical colonic delivery 1. CONSISTENT Colonic delivery regardless of GI motility, ü Demonstrated in BT-600 Phase 1 trial PHARMACOKINETICS which can vary between patients and across and in NaviCap scintigraphy device disease activity function studies 2. PRECISION RELEASE Rel
Slide 29: NaviCap Targeted Oral Delivery
NAVIcap" TARGETED ORAL DELIVERY
Slide 30: The NaviCap platform accurately delivers drug to colon
The NaviCap platform accurately delivers drug to colon • Could achieve desired tissue exposure while decreasing undesired systemic exposure • Could deliver better than current 20–30% efficacy rates while also enabling combination therapies • NaviCap platform could be used for multiple drugs and drug
Slide 31: Biora Therapeutics
IORA herapeutics