EX-99.2 3 d821796dex992.htm EX-99.2 EX-99.2

Exhibit 99.2

 

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CORPORATE PRESENTATION July 2024


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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 fact included in this presentation, including statements concerning our plans, objectives, goals, strategies, future events, plans or intentions relating to product candidates, estimates of market size, the anticipated timing, design and conduct of our planned pre-clinical and clinical trials, including with respect to BT-600 and our NaviCap platform, the anticipated timing for pre-clinical and clinical data, the development of our product candidates, the potential clinical benefits of our product candidates, including efficacy and safety benefits, the potential benefits of strategic partnerships and licensing arrangements and our intent to enter into any strategic partnerships or licensing arrangements, the timing and likelihood of success, plans and objectives of management for future operations and future results of anticipated product development efforts, are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “plan” or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this presentation, including competition from third parties with respect to our product candidates; risks related to the supply and manufacturing of and complexity of components in our devices; whether we will be able to develop our precision medicine products, and, if developed, that such product candidates will be authorized for marketing by regulatory authorities, or will be commercially successful; risks related to our continued listing on the Nasdaq Global Market; and those described in “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, and elsewhere in such filing and in other subsequent disclosure documents, including our Quarterly Reports on Form 10-Q, filed with the U.S. Securities and Exchange Commission. We cannot assure you that we will realize the results, benefits or developments that we expect or anticipate or, even if substantially realized, that they will result in the consequences or affect us or our business in the way expected. Forward-looking statements are not historical facts and reflect our current views with respect to future events. Given the significant uncertainties, you should evaluate all forward-looking statements made in this presentation in the context of these risks and uncertainties and not place undue reliance on these forward-looking statements as predictions of future events. All forward-looking statements in this presentation apply only as of the date made and are expressly qualified in their entirety by the cautionary statements included in this presentation. We disclaim any intent to publicly update or revise any forward-looking statements to reflect subsequent events or circumstances, except as required by law. Industry and Market Data: We obtained the industry, market, and competitive position data used throughout this presentation from our own internal estimates and research, as well as from industry and general publications, and research, surveys, and studies conducted by third parties. Internal estimates are derived from publicly available information released by industry analysts and third-party sources, our internal research and our industry experience, and are based on assumptions made by us based on such data and our knowledge of the industry and market, which we believe to be reasonable. In addition, while we believe the industry, market, and competitive position data included in this prospectus is reliable and based on reasonable assumptions, we have not independently verified any third-party information, and all such data involve risks and uncertainties and are subject to change based on various factors. These and other factors could cause results to differ materially from those expressed in the estimates made by the independent parties and by us. 2 © 2024 Biora Therapeutics, Inc. All rights reserved.


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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 management of chronic diseases 3 © 2024 Biora Therapeutics, Inc. All rights reserved.


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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 Delivery Platform — AstraZeneca collaboration undisclosed antisense Ionis collaboration oligonucleotide Multiple pharma collaborations undisclosed *Biora’s own molecules 4 © 2024 Biora Therapeutics, Inc. All rights reserved.


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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 © 2024 Biora Therapeutics, Inc. All rights reserved.


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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 after • Inflammatory bowel INDUCTION induction with any drug therapy(1,2) disease (IBD) includes TRIAL NO Crohn’s disease and RESPONSE ulcerative colitis (UC) • UC causes inflammation 60% of patients in remission RELAPSE and damage to the large relapse within 12 months(2) intestine INDUCTION • About 1 million people in TRIAL Patients undergo induction (2-3 the U.S. are affected with MAINTENANCE months) with different drug UC, and ~40,000 cases are Patients in remission continue Efficacy rate decreases with diagnosed each year(3) drug therapy to prevent relapse successive rounds of therapy(1) 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. 2. Hirten RP, Sands BE. New Therapeutics for Ulcerative Colitis. Annu Rev Med. 2021;72:199-213. 3. Shivashankar R, Tremaine WJ, Harmsen WS, Loftus EV Jr. Incidence and Prevalence of Crohn’s Disease and Ulcerative Colitis in Olmsted County, Minnesota From 1970 Through 2010. Clin Gastroenterol Hepatol. 2017;15(6):857-863. 7 © 2024 Biora Therapeutics, Inc. All rights reserved.


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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 site of disease 1 correlated with improved outcomes Reduced systemic uptake is Systemic toxicity issues may 2 designed to reduce toxicity and limit daily dosage of UC drugs adverse events 3 Combination therapy is Reduced toxicity could enable limited by toxicity combination therapy2 Development in partnership with: 1. 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 Organisation (ECCO), February 18, 2022, virtual. 2. van Oostrom J, Verstockt B, Hanzel J, et al. Pharmacokinetic stratification of cytokine profiles during anti-TNF induction treatment in moderate-to-severe ulcerative colitis. Poster presented at: 17th Congress of the European Crohn’s and Colitis Organisation (ECCO), February 18, 2022, virtual. 8 © 2024 Biora Therapeutics, Inc. All rights reserved.


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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 DELIVERY Method designed to coat the length of the colon with liquid formulation, minimizing systemic uptake 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 colon. Poster presented at: Crohn’s & Colitis Congress, January 19-21, 2023, Denver, CO. 9 © 2024 Biora Therapeutics, Inc. All rights reserved.


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Autonomous location and delivery to the colon https://biora.wistia.com/medias/r65935rbqs 10 © 2024 Biora Therapeutics, Inc. All rights reserved.


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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 Patients with Study in Healthy Study in Healthy Participants – Fasted State Active UC – Fasted State Participants – Fasted & Fed Participants – Fasted State 83% of devices (10/12) 100% of devices (7/7) 100% of analyzed devices 94% of devices (15/16) accurately identified entry accurately identified entry (39/39) identified entry to the accurately identified entry into the colon1 into the colon, triggered colon and activated gas cells into the colon, triggered release of a liquid payload, for delivery in all fasted/fed release of a liquid payload, Achieved distribution of 1 and achieved distribution schedules and achieved distribution payload across the entire 1 1 across the entire colon 97.4% of analyzed devices across the entire colon colon, no early deployment before colon detection1 (38/39) activated the payload release function1 HEALTHY ACTIVE UC FUNCTION WITH/ PHASE 1-READY PARTICIPANTS PATIENTS WITHOUT FOOD DEVICE 1. Lee SN, Razag G, Kelly C, et al. Results of human device function studies for the NaviCa Targeted Oral Delivery Platform in healthy volunteers and patients with UC. Poster presented at: Digestive Disease Week, May 18 – 21, 2024, Washington DC. 11 © 2024 Biora Therapeutics, Inc. All rights reserved.


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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.bioratherapeutics.com/pipeline/targeted-therapeutics#scintigraphy 12 © 2024 Biora Therapeutics, Inc. All rights reserved.


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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 Placebo n=3 MAD 5mg 7x QD n=9 24 subjects Placebo n=3 Baseline D1 D2 D3 D4 D5 D6 D7 D8 Blood Blood Stool Blood & Stool Tissue PATIENT Total of 48 healthy participants POPULATION (24 SAD and 24 MAD participants) TRIAL Randomized, double-blind, placebo-controlled clinical trial to evaluate the safety, tolerability, and DESIGN PK of SAD and MAD doses of BT-600 in healthy participants 13 © 2024 Biora Therapeutics, Inc. All rights reserved.


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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 colonic (vs. upper GI) delivery ORAL DOSE OF 5 mg AND 10 mg BT-600Tmax8-10 hours (vs. 0.5 hours for conventional oral tofacitinib(1)) • Colonic delivery associated with 3-4x lower systemic absorption • Cmaxmean 26 ng/mL for BT-600 10 mg dose (vs. 88 ng/mL for conventional oral tofacitinib(1)) • Consistently lower drug concentrations observed with 5 mg vs. 10 mg dose 1. Krishnaswami S, Boy M, Chow V, Chan G. Safety, tolerability, and pharmacokinetics of single oral doses of tofacitinib, a Janus kinase inhibitor, in healthy volunteers. Clin Pharmacol Drug Dev. 2015;4(2):83-88. doi:10.1002/cpdd.171 14 © 2024 Biora Therapeutics, Inc. All rights reserved.


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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 than seen with Xeljanz1 delivery in the colon • Demonstrated ability to deliver tofacitinib to the colon with lower systemic levels than seen with conventional oral delivery in both SAD/MAD cohorts1 COLON TISSUE EXPOSURE Demonstrated pan- • After delivery to the proximal colon, tofacitinib was detected across multiple colonic drug delivery biopsy sites in the distal colon • Distribution of tissue exposure consistent with delivery to the entire colon DEVICE FUNCTION Accurately delivered • 100% of devices (SAD) and 98% of devices (MAD) successfully detected to the colon colon entry SAFETY & TOLERABILITY Showed safety of daily • BT-600 was well tolerated by participants in SAD and MAD cohorts administration Further details to be presented at virtual KOL event on July 17, 2024 Data on file, Biora Therapeutics, Inc. 1. These data are derived from different clinical trials at different points in time, with differences in trial design and patient populations. As a result, cross-trial comparisons cannot be made, and no head-to-head clinical trials have been conducted. 15 © 2024 Biora Therapeutics, Inc. All rights reserved.


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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 inform Ph2 dose selection delivered via NaviCap Population Population Population 48 healthy participants ~15 UC patients ~150 UC patients Design Design Design Single-center SAD/MAD trial Single-center trial Global multicenter induction efficacy trial Endpoints Endpoints Endpoints • Safety & tolerability • Safety & tolerability • Clinical and endoscopic response • PK/PD • PK/PD • Mucosal healing • Device function • Device function • PROs • Biomarkers PLANNED START: Q4 2024 PLANNED START: Q4 2025 COMPLETE DURATION: 6 MO DURATION: TBD 16 © 2024 Biora Therapeutics, Inc. All rights reserved.


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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 correlate with better outcomes: • JAK inhibitors1 IL-12/23 Inhibitors 2 TNF Inhibitors • TNF inhibitors • Stelara (ustekinumab) • Humira (adalimumab) • Integrin inhibitors3 • Omvoh (mirikizumab) • Remicade (infliximab) • Skyrizi (risankizumab- • Simponi (golimumab) • NaviCap could optimize therapeutic classes rzaa) by enabling drugs to reach and act in the colon for better outcomes in UC and beyond S1P Receptor UC THERAPEUTICS GLOBAL SALES4 Modulators Integrin Inhibitors • Zeposia (ozanimod) • Entyvio (vedolizumab) $13B • Velsipity (etrasimod) $11B $9B JAK Inhibitors • Xeljanz (tofacitinib) Biosimilars • Rinvoq (upadacitinib) • Jyseleca (filgotinib) 2024 2027 2030 1. Verstockt B, Alsoud D, van Oostrom J, et al. Poster presented at: 17th Congress of the European Crohn’s and Colitis Organisation (ECCO), February 18, 2022, virtual. 2. Yarur AJ, Jain A, Sussman DA, et al. The association of tissue anti-TNF drug levels with serological and endoscopic disease activity in inflammatory bowel disease: the ATLAS study. Gut. 2016;65(2):249-255. doi:10.1136/gutjnl-2014-308099 3. Pauwels RWM, Proietti E, van der Woude CJ, et al. Vedolizumab Tissue Concentration Correlates to Mucosal Inflammation and Objective Treatment Response in Inflammatory Bowel Disease. Inflamm Bowel Dis. 2021;27(11):1813-1820. doi:10.1093/ibd/izab053 4. GlobalData, Ulcerative Colitis: Global Drug Forecast and Market Analysis to 2029 (2020), based on 6.0% CAGR 5. GlobalData, Ulcerative Colitis: Global Drug Forecast and Market Analysis to 2029 (2020), based on forecasted 2029 global sales 17 © 2024 Biora Therapeutics, Inc. All rights reserved.


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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 rate for diabetes 71% patients initiating treatment with an injectable GLP-1 agonist vs. those starting oral therapy2 1. Palanca A, Ampudia-Blasco FJ, Calderón JM, et al. Real-World Evaluation of GLP-1 Receptor Agonist Therapy Persistence, Adherence and Therapeutic Inertia Among Obese Adults with Type 2 Diabetes. Diabetes Ther. 2023;14(4):723-736. doi:10.1007/s13300-023-01382-9 2. Spain CV, Wright JJ, Hahn RM, Wivel A, Martin AA. Self-reported Barriers to Adherence and Persistence to Treatment With Injectable Medications for Type 2 Diabetes. Clin Ther. 2016;38(7):1653-1664.e1. doi:10.1016/j.clinthera.2016.05.009 19 © 2024 Biora Therapeutics, Inc. All rights reserved.


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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 reformulation • Deliver large payloads in the multi-milligram range Ionis 20 © 2024 Biora Therapeutics, Inc. All rights reserved.


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Liquid jet delivery to the small intestine https://biora.wistia.com/medias/embr15eh3a 21 © 2024 Biora Therapeutics, Inc. All rights reserved.


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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 of (ng/mL) • Average oral bioavailability vs. 100 36% ± 10% (n=55; SD ~25%)1 10 • Detectable drug levels up to ten days post-dosing Semaglutide 1 • No significant clinical signs observed in any of the 0.1 animals for up to 10 days 0 24 48 72 96 120 144 168 192 216 240 Time Post-dose (hr) 1. Biora Therapeutics, Inc. Data on file. Average bioavailability calculation is based on animals with drug in blood across studies using multiple device configurations. 22 © 2024 Biora Therapeutics, Inc. All rights reserved.


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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 • Detectable drug levels up to ten days post-dosing 001 1000 • No significant clinical signs observed in any of the—BT animals for up to 10 days 100 10 0 12 24 36 48 60 72 96 120 Time Post Dose (hour) 1. Biora Therapeutics, Inc. Data on file. Average bioavailability calculation is based on animals with drug in blood across studies using multiple device configurations. 23 © 2024 Biora Therapeutics, Inc. All rights reserved.


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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 maximize systemic uptake • Delivers large payload at • Provides opportunity to • Enables liver-targeted multi-milligram doses extend drug exclusivity delivery of large molecules • Leverages liquid formulation without complex reformulation 24 © 2024 Biora Therapeutics, Inc. All rights reserved.


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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% mean oral bioavailability semaglutide PEPTIDE vs. IV control (GLP-1 receptor agonist) demonstrated across all three biomolecule types1 undisclosed antisense multiple undisclosed OLIGONUCLEOTIDE oligonucleotides pharma collaborators 1. Biora Therapeutics data on file 25 © 2024 Biora Therapeutics, Inc. All rights reserved.


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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 Therapeutics, Inc. All rights reserved.


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APPENDIX


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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 covering: 36 patent families covering: • Device designs, materials, • Device designs, materials, • Ingestible devices for GI components, and manufacturing components, and manufacturing sampling and diagnostics • Localization in the GI tract • GI-specific trigger compositions • GI sample preservation • Dosing and PK/PD profiles • Dosing and PK/PD profiles • GI analyte detection & quantification • Liquid drug formulations • Jet parameters • Diagnostic biomarkers & assays • IBD-specific drug combinations • GI delivery by drug class and drug size 28 © 2024 Biora Therapeutics, Inc. All rights reserved.


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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 adoptive transfer of CD44-/CD62L+ T-cells into RAG2-/- mice recipients. Presented at DDW 2019. 3. Targeted delivery of soluble tofacitinib citrate to the site of inflammation to improve efficacy and safety. Poster presented at DDW 2021. 4. Development of a novel drug delivery system for treatment of Ulcerative Colitis. Poster resented at DDW 2021. 5. Development of a Novel Drug Delivery System to Deliver Drugs Directly to the Colonic Mucosa, Resulting in Improved Efficacy and Reduced Systemic Exposure for the Treatment of Ulcerative Colitis. Crohn’s & Colitis 360. 2021, 3, 1–5. 6. Tofacitinib tissue exposure correlates with endoscopic outcome. Oral presentation at DDW 2022 and BWG. Poster presented at ECCO 2022. 7. Pharmacokinetic stratification of cytokine profiles during anti-TNF induction treatment in moderate-to-severe UC. Poster presented at ECCO 2022 and DDW 2022. 8. Pilot study to assess pharmacokinetic and pharmacodynamic markers following enema-dosing with adalimumab in patients with active ulcerative colitis. Poster presented at ACG 2022. 9. 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 ACG 2022. 10. A scintigraphic study to evaluate the localization and delivery function of a Drug Delivery System (DDS) device in patients with active ulcerative colitis (UC) in fasted state. Poster presented at ACG 2022. 11. Development of a novel Drug Delivery System (DDS) to deliver drugs directly to the colonic mucosa to improve efficacy and reduce systemic exposure for the treatment of ulcerative colitis (UC). Poster presented at Crohn’s & Colitis Congress 2023. 12. Potential effects of food on a novel Drug Delivery System (DDS) to deliver therapeutic compound into the colon. Poster presented at Crohn’s & Colitis Congress 2023. 13. Results of human device function studies for the NaviCa Targeted Oral Delivery Platform in healthy volunteers and patients with UC. Poster presented at Digestive Disease Week 2024. 29 © 2024 Biora Therapeutics, Inc. All rights reserved. see bioratherapeutics.com/publications


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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 Gastroenterology Annual Scientific Meeting, October 21-26, 2022. 2. Assessing the performance of an oral biotherapeutic delivery system (OBDS) using intra-duodenal endoscopy delivery in Yucatan minipigs. Poster presented at the Controlled Release Society Annual Meeting, July 13-14, 2022 and at the American College of Gastroenterology Annual Scientific Meeting, October 21-26, 2022. 3. Development of preclinical models to assess the performance of the oral biotherapeutic delivery system (OBDS) capsule. Poster presented at the Parenteral Drug Association Universe of Pre-Filled Syringes and Injection Devices Conference, October 18-19, 2022. 4. Evaluation of the pharmacokinetics of glucagon-like-peptide-1 (GLP-1) receptor agonist delivered through the BioJ oral biotherapeutic delivery platform in a porcine model. Poster presented at the American Diabetes Association 83rd Scientific Sessions, June 23-26, 2023. 5. Evaluation of the pharmacokinetics of glucagon-like-peptide-1 (GLP-1) receptor agonist delivered through the BioJ oral biotherapeutic delivery platform in a porcine model: an update. Poster presented at the 59th Annual Meeting of the European Association for the Study of Diabetes, October 2-6, 2023. 6. Empowering Peptide Self Administration with Needle-Free Smart Capsules. Oral presentation at the Next-Gen Peptide Formulation & Delivery Summit, June 19, 2024. 30 © 2024 Biora Therapeutics, Inc. All rights reserved. see bioratherapeutics.com/publications


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