8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 OR 15(d)

of The Securities Exchange Act of 1934

Date of report (Date of earliest event reported): July 1, 2024

Biora Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

Delaware	001-39334	27-3950390
(State or other jurisdiction of incorporation)	(Commission File Number)	(IRS Employer Identification No.)

4330 La Jolla Village Drive, Suite 300
San Diego, California	92122
(Address of principal executive offices)	(Zip Code)

Registrant’s telephone number, including area code: (833) 727-2841

N/A

(Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, par value $0.001 per share	BIOR	The Nasdaq Global Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 7.01 Regulation FD Disclosure

On July 1, 2024, Biora Therapeutics, Inc. (the “Company”) issued a press release announcing positive topline results from its clinical trial of BT-600. The Company will hold a conference call with members of its Clinical Advisory Board on July 17, 2024 to provide additional details regarding the data results.

Also on July 1, 2024, the Company made available an updated corporate presentation on the Company’s website.

Copies of the press release and the corporate presentation are furnished as Exhibits 99.1 and 99.2 to this Current Report on Form 8-K and are incorporated by reference herein. The exhibits furnished under Item 7.01 of this Current Report on Form 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, regardless of any general incorporation language in such filing.

Item 8.01 Other Events

On July 1, 2024, the Company announced the following positive topline results from its clinical trial of BT-600, an orally-administered drug-device combination in development for the potential treatment of patients with ulcerative colitis that leverages the Company’s ingestible NaviCap^™ device to deliver a proprietary liquid formulation of tofacitinib directly to the colon:

Summary of Key BT-600 Phase 1 Trial Results

Results from the Phase 1 clinical trial demonstrate a pharmacokinetic profile consistent with drug delivery and absorption in the colon for both single and multiple ascending dose (“SAD/MAD”) cohorts.

• First evidence of systemic absorption of tofacitinib was at six hours, consistent with colonic (vs. upper gastrointestinal) delivery. Maximal levels in the trial occurred at eight to ten hours vs. 30 minutes for conventional oral tofacitinib in other trials.

• Maximal systemic drug exposure was three to four times lower than that seen with conventional oral tofacitinib in other trials, demonstrating the NaviCap platform’s ability to deliver locally to the colon and limit systemic drug exposure.

The distribution of colon tissue exposure suggests that pan-colonic delivery of tofacitinib was achieved.

• Sites in the distal colon were biopsied, following delivery of tofacitinib in the proximal colon, for evidence of tissue drug exposure.

• Biopsy results provided evidence of drug exposure extending to the distal colon, at common sites of disease.

• Post-retrieval device analysis further confirmed that NaviCap devices accurately delivered drug in the colon, with 100% of devices (SAD) and 98% of devices (MAD) detecting colon entry.

NaviCap devices were well tolerated by participants in both the SAD and MAD cohorts.

Phase 1 Clinical Trial Design

The objectives of this Phase 1 randomized, double-blind, placebo-controlled, SAD/MAD clinical trial were to evaluate the safety and pharmacokinetics of BT-600 when administered orally in healthy adult participants. The trial, which was conducted in the United States, consisted of two parts: The first part was comprised of 24 participants receiving a single ascending dose of BT-600 with tofacitinib at 5 mg or 10 mg doses or placebo. The

second part was comprised of 24 participants receiving multiple ascending-doses of BT-600 with tofacitinib at 5 mg or 10 mg doses or placebo daily for 7 days. The trial is listed at clinicaltrials.gov (NCT06275464). The “other trials” referred to in the summary of the Phase 1 clinical trial results above were conducted at different times, 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.

Item 9.01 Financial Statements and Exhibits

(d) Exhibits.

EXHIBIT INDEX

Exhibit No.	Description
99.1	Press Release, dated July 1, 2024
99.2	Corporate Presentation (July 2024)
104	Cover Page Interactive Data File (embedded within the Inline XBRL document).

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	Biora Therapeutics, Inc.
Date: July 1, 2024	By:	/s/ Eric d’Esparbes
	Name:	Eric d’Esparbes
	Title:	Chief Financial Officer

EX-99.1

Exhibit 99.1

Biora Therapeutics Announces Positive Clinical Trial Results for BT-600

Drug-device combination leverages Biora’s NaviCap^™ platform to deliver tofacitinib directly to colonic tissue as a potential treatment for ulcerative colitis

BT-600 was well tolerated and met all trial objectives, demonstrating the NaviCap platform’s ability to deliver therapeutics directly to the colon

Drug absorption in colonic tissue extended to distal colon, suggesting pan-colonic delivery

Company to host virtual event with key opinion leaders on July 17

SAN DIEGO, July 1, 2024 – Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company reimagining therapeutic delivery, today shared positive topline results from its clinical trial of BT-600, an orally administered drug-device combination in development for the potential treatment of patients with ulcerative colitis (UC). BT-600 leverages Biora’s ingestible NaviCap^™ device to deliver a proprietary liquid formulation of tofacitinib directly to the colon. Results from this Phase 1 clinical trial involving 48 healthy volunteers met all trial objectives, with demonstrated drug absorption in colonic tissue that extended to the distal colon, suggesting pan-colonic delivery. Daily dosing with BT-600 was well tolerated by all participants.

“Successful completion of our Phase 1 clinical trial is an important milestone for Biora,” said Ariella Kelman, MD, Chief Medical Officer of Biora Therapeutics. “All study objectives were met, and we confirmed that the NaviCap platform can deliver tofacitinib topically to the colon, with lower peak systemic exposure than with conventional oral delivery. These results support our plan to advance BT-600 into our Phase 1b clinical trial in patients with UC.”

“We are extremely encouraged by the results from this trial, which demonstrate the NaviCap platform’s ability to deliver drug to the location of disease, where it’s needed,” said Adi Mohanty, Chief Executive Officer of Biora Therapeutics. “Our anatomically targeted approach has the potential to improve the efficacy of JAK inhibitors and other drug classes. We envision a portfolio of NaviCap-delivered therapeutics unlocking new treatment potential for patients with GI diseases.”

“I would like to thank the study participants, clinicians, and our Biora team for conducting such a well-executed trial,” continued Mr. Mohanty. “Our team continues to execute at a high level as we meet our NaviCap platform milestones, while the BioJet^™ platform is also progressing well and is on track to meet our previously stated goals.”

Summary of Key BT-600 Phase 1 Trial Results

Results from the Phase 1 clinical trial demonstrate a pharmacokinetic (PK) profile consistent with drug delivery and absorption in the colon for both single and multiple ascending dose (SAD/MAD) cohorts.

• First evidence of systemic absorption of tofacitinib was at six hours, consistent with colonic (vs. upper gastrointestinal) delivery. Maximal levels in the trial occurred at eight to ten hours vs. 30 minutes for conventional oral tofacitinib in other trials.

• Maximal systemic drug exposure was three to four times lower than that seen with conventional oral tofacitinib in other trials, demonstrating the NaviCap platform’s ability to deliver locally to the colon and limit systemic drug exposure.

The distribution of colon tissue exposure suggests that pan-colonic delivery of tofacitinib was achieved.

• Sites in the distal colon were biopsied, following delivery of tofacitinib in the proximal colon, for evidence of tissue drug exposure.

• Biopsy results provided evidence of drug exposure extending to the distal colon, at common sites of disease.

• Post-retrieval device analysis further confirmed that NaviCap devices accurately delivered drug in the colon, with 100% of devices (SAD) and 98% of devices (MAD) detecting colon entry.

NaviCap devices were well tolerated by participants in both the SAD and MAD cohorts.

Virtual Event Details

The company will host a KOL event with members of management and its Clinical Advisory Board to provide additional details regarding the Phase 1 trial and plans for the next phase of clinical development.

Date:	Wednesday, July 17, 2024
Time:	2:00 PM Eastern / 11:00 AM Pacific time
Live Webcast:	https://lifescievents.com/event/biora/

Attendees may register in advance using the webcast link above. A replay will be available online following the event.

Phase 1 Clinical Trial Design

The objectives of this Phase 1 randomized, double-blind, placebo-controlled, single and multiple ascending dose (SAD/MAD) clinical trial were to evaluate the safety and pharmacokinetics of BT-600 when administered orally in healthy adult participants. The trial, which was conducted in the United States, consisted of two parts: The first part was comprised of 24 participants receiving a single ascending dose of BT-600 with tofacitinib at 5 mg or 10 mg doses or placebo. The second part was comprised of 24 participants receiving multiple ascending-doses of BT-600 with tofacitinib at 5 mg or 10 mg doses or placebo daily for 7 days. The trial is listed at clinicaltrials.gov (NCT06275464). The “other trials” referred to in the summary of the Phase 1 clinical trial results above were conducted at different times, 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.

About BT-600

BT-600 is a drug/device combination of Biora’s NaviCap^™ ingestible drug delivery device with a proprietary liquid formulation of tofacitinib, for the potential treatment of moderate to severe ulcerative colitis. The NaviCap device is orally administered and has been designed for anatomically targeted therapeutic delivery directly to the colon in this application.

About the NaviCap^™ Targeted Oral Delivery Platform

Biora’s NaviCap targeted oral therapeutics platform utilizes a novel approach that could improve patient outcomes by enabling delivery of therapeutics directly to the site of disease, increasing therapeutic activity in tissue while reducing systemic uptake. For the 1.8 million patients in the United States who suffer from inflammatory bowel disease (IBD), existing therapeutics offer less than ideal efficacy, likely because of the challenges with safely achieving sufficient drug activity in the affected tissues. Research has shown that targeted delivery of therapeutics has the potential to improve patient outcomes in IBD.

The NaviCap platform uses an ingestible device designed for targeted delivery of therapeutics to improve treatment of ulcerative colitis. Once swallowed, Biora’s GItrac^™ autolocation technology enables the device to autonomously identify targeted locations in the GI tract and release a therapeutic dose of up to 500µl. Studies of the NaviCap device in healthy volunteers and patients with ulcerative colitis demonstrated successful delivery to the colon regardless of variable GI conditions, in both fasted and fed states.

About Ulcerative Colitis

Ulcerative colitis (UC) is a type of IBD that causes chronic inflammation and damage to the colon. Common symptoms include abdominal pain, increased bowel movements, stool urgency, and rectal bleeding. Despite the availability of advanced treatments for UC, including biologics, immunomodulators, and targeted synthetic small molecules, only about 40% of patients achieve clinical remission in induction trials. Surgical intervention is needed in approximately 20% of UC patients, with up to 10% of patients requiring surgical removal of the colon. About 1.5 million people are affected with UC in the United States alone, and ~40,000 new cases are diagnosed each year.

About Biora Therapeutics

Biora Therapeutics is reimagining therapeutic delivery. By creating innovative smart pills designed for targeted drug delivery to the GI tract, and systemic, needle-free delivery of biotherapeutics, the company is developing therapies to improve patients’ lives.

Biora is focused on development of two therapeutics platforms: the NaviCap^™ targeted oral delivery platform, designed to improve outcomes for patients with inflammatory bowel disease through treatment at the site of disease in the gastrointestinal tract, and the BioJet^™ systemic oral delivery platform, designed to replace injection for better management of chronic diseases through needle-free, oral delivery of large molecules.

For more information, visit bioratherapeutics.com or follow the company on LinkedIn or X.

Safe Harbor Statement or Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, including statements concerning the progress and future expectations and goals of our research and development, preclinical and clinical trial activities, including those involving BT-600 and our NaviCap platform, and partnering and collaboration efforts with third parties, are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “envision,” “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “anticipate,” “forward,” “believe,” “design,” “estimate,” “predict,” “potential,” “plan,” “goal(s)” “target,” or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements reflect our plans, estimates, and expectations, as of the date of this press release. 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 press release. Such risks, uncertainties, and other factors include, among others, our ability to innovate in the field of therapeutics, our ability to make future FDA filings and initiate and execute clinical trials on expected timelines or at all, our ability to obtain and maintain regulatory approval or clearance of our products on expected timelines or at all, our plans to research, develop, and commercialize new products, the unpredictable relationship between preclinical study results and clinical study results, our expectations regarding allowed patents or intended grants to result in issued or granted patents, our expectations regarding opportunities with current or future pharmaceutical collaborators or partners, our ability to raise sufficient capital to achieve our business objectives, our ability to maintain our listing on the Nasdaq Global Market, and those risks 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 year ended December 31, 2023 filed with the Securities and Exchange Commission (SEC) and other subsequent documents, including Quarterly Reports on Form 10-Q, that we file with the SEC.

Biora Therapeutics expressly disclaims any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.

Investor Contact

Chuck Padala

Managing Director, LifeSci Advisors

IR@bioratherapeutics.com

(646) 627-8390

Media Contact

Liz Robinson

CG Life

lrobinson@cglife.com

EX-99.2

Exhibit 99.2

CORPORATE PRESENTATION July 2024

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.

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.

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.

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.

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.

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.

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.

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

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.

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.

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.

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-600 • Tmax8-10 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.

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.

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.

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.

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.

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.

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

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.

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.

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.

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.

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.

APPENDIX

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.

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

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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