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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 17, 2024
Biora Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
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| Delaware |
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001-39334 |
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27-3950390 |
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(Commission |
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(IRS Employer |
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File Number) |
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Identification No.) |
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| 4330 La Jolla Village Drive, Suite 300 |
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| San Diego, California |
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92122 |
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(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:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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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:
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Trading Symbol(s) |
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Name of each exchange on which registered |
| Common Stock, par value $0.001 per share |
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BIOR |
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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 18, 2024, Biora Therapeutics, Inc. (the “Company”) issued a press release announcing supplemental data from its Phase 1 clinical trial of BT-600.
A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein. The exhibit 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 it 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.
On July 17, 2024, the Company held a conference call with members of its Clinical Advisory Board to present the additional data and made available an updated corporate presentation on the Company’s website.
A copy of the corporate presentation is filed as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated by reference herein.
On July 18, 2024, the Company announced the following supplemental data 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.
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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. |
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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.
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Sites in the distal colon were biopsied, following delivery of tofacitinib in the proximal colon. |
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Biopsy results provided evidence of drug exposure extending to the distal colon, at common sites of disease. |
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Modeling projects tissue levels at or above the estimated IC90 through at least 16 hours after dosing. |
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Post-retrieval device analysis further confirmed that NaviCap devices accurately delivered drug in the colon, with no early release, and with >95% of devices detecting colon entry. |
NaviCap devices were well tolerated by participants in both the SAD and MAD cohorts.
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All adverse events were mild and consistent with those expected in a healthy population. |
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No evidence of device or drug colon toxicity; colon tissue histology within normal limits. |
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No notable changes or differences in safety laboratory parameters between groups. |
Tissue biopsies were performed to assess drug concentration in colonic tissues at 24 hours after dosing during the Phase 1 trial in healthy participants. Mean tissue concentrations for the splenic flexure, descending colon, and sigmoid colon were above the established IC50 for the JAK-STAT pathway, and a strong correlation was shown between tissue and corresponding plasma levels. The plasma/tissue correlation was used to model tissue levels at earlier time points, with the model projecting tissue levels above the IC90 through at least 16 hours after dosing with BT-600.
| Item 9.01 |
Financial Statements and Exhibits |
(d) Exhibits.
EXHIBIT INDEX
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.
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Biora Therapeutics, Inc. |
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| Date: July 18, 2024 |
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By: |
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/s/ Eric d’Esparbes |
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Name: |
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Eric d’Esparbes |
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Chief Financial Officer |
Exhibit 99.1
Biora Therapeutics Announces Supplemental Data from Phase 1 Clinical Trial of BT-600 as Presented at KOL Event
Pharmacokinetic and tissue data confirm NaviCap platform
delivers topically through the entire colon, with lower systemic concentrations, as desired
Data modeling suggests tofacitinib
tissue concentrations greater than IC90 through at least 16 hours after dosing
SAN DIEGO, July 18, 2024 – Biora Therapeutics, Inc.
(Nasdaq: BIOR), the biotech company reimagining therapeutic delivery, presented supplemental data from the Phase 1 trial of BT-600 during the company’s virtual KOL event on Wednesday, July 17, 2024. BT-600, an orally administered drug-device combination, is in development for the 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.
“We are excited by the colon tissue drug exposure we are seeing in this trial,” said Ariella Kelman, MD, Chief Medical Officer of Biora
Therapeutics. “We observed levels above the IC50 at 24 hours and five half-lives after dosing, despite extensive pre-procedure colon prep. We know higher tissue levels are associated with better responses
to tofacitinib in UC, and our model projects tissue levels well above IC90 through at least 16 hours post dose. This is especially notable since we studied daily doses of 5 mg and 10 mg in this trial, which are 50–75% lower than approved doses
for conventional tofacitinib. We also observed lower systemic concentrations, which may be associated with reduced toxicity risks.”
Tissue biopsies
were performed to assess drug concentration in colonic tissues at 24 hours after dosing during the Phase 1 trial in healthy participants. Mean tissue concentrations for the splenic flexure, descending colon, and sigmoid colon were above the
established IC50 for the JAK-STAT pathway, and a strong correlation was shown between tissue and corresponding plasma levels. The plasma/tissue correlation was used to model tissue levels at earlier time
points, with the model projecting tissue levels above the IC90 through at least 16 hours after BT-600 5 mg or 10 mg doses.
“The results of this trial confirm that BT-600 can deliver drug topically throughout the length of the colon and
could achieve both of our pharmacokinetic goals: higher tissue exposure and lower systemic concentrations. This certainly gives us confidence as we move into our planned clinical trial in UC patients,” continued Dr. Kelman.
“There is an urgent need to break the therapeutic ceiling of 20–30% remission rates over placebo in UC,” said Adi Mohanty, Chief Executive
Officer of Biora Therapeutics. “We plan to break through by changing the way gastrointestinal diseases are treated with our NaviCap platform, which can reliably deliver to specific locations within the GI tract. The clinical trial results for
our current program, BT-600, demonstrate its potential and also provide proof of concept for the NaviCap platform’s ability to deliver other molecules and drug classes in UC and beyond.”
Biora’s virtual KOL event on July 17 featured Bruce Sands, MD, MS (Icahn School of Medicine at
Mount Sinai) and Brian Feagan, MD, FRCPC (Schulich School of Medicine & Dentistry at the University of Western Ontario), who discussed the unmet need and current treatment landscape for patients with UC, as well as the value of colonic drug
delivery for improving efficacy. A replay of the live event can be accessed on the company’s website.
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:
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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. |
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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:
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Sites in the distal colon were biopsied, following delivery of tofacitinib in the proximal colon.
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Biopsy results provided evidence of drug exposure extending to the distal colon, at common sites of disease.
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Modeling projects tissue levels at or above the estimated IC90 through at least 16 hours after dosing.
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Post-retrieval device analysis further confirmed that NaviCap devices accurately delivered drug in the colon,
with no early release, and with >95% of devices detecting colon entry. |
NaviCap devices were well tolerated by participants in both
the SAD and MAD cohorts:
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All AEs were mild and consistent with those expected in a healthy population. |
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No evidence of device or drug colon toxicity; colon tissue histology was within normal limits.
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There were no notable changes or differences in safety laboratory parameters between groups.
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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 model projections, 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,” “projects,” “projecting,”
“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
Exhibit 99.2 UNMET NEEDS IN ULCERATIVE COLITIS BT-600 PHASE 1 TRIAL
RESULTS July 17, 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 and model projections, 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 “envision,” “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,”
“would,” “expect,” “believe,” “design,” “estimate,” “predict,” “projects,” “projecting,” “potential,” “plan,” goal(s),” 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.
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
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
© 2024 Biora Therapeutics, Inc. All rights reserved.
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 infiltrate with loss
of crypts and thin epithelium (black arrow) and cryptitis/crypt abscesses (arrows) dense lymphoplasmacytic and neutrophilic infiltrate 5 Images courtesy of Dr. Mabel Ko © 2024 Biora Therapeutics, Inc. All rights reserved.
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) (n=309)
long-term stressful embarassed always feel effects depressed *p<0.05 vs. other chronic conditions Internet survey designed to address a variety of disease impact indices 6 1. Rubin DT, Dubinsky MC, Panaccione R, et al. The impact of ulcerative
colitis on patients' lives compared to other chronic diseases: a patient survey. Dig Dis Sci. 2010;55(4):1044-1052. doi:10.1007/s10620-009-0953-7 © 2024 Biora Therapeutics, Inc. All rights reserved. Proportion of patients (%) Proportion of
patients (%)
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. All rights
reserved.
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 of disease 1 correlated
with improved outcomes Reduced systemic uptake is Systemic toxicity issues may designed to reduce toxicity and 2 limit daily dosage of UC drugs adverse events Combination therapy is Reduced toxicity could enable 3 2 limited by toxicity combination
therapy 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 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
delivered into systemic • Lower drug levels in systemic circulation circulation TISSUE TO BLOOD • Dose limited due to systemic toxicity colon, cross section area of payload release (ascending colon) 9 © 2024 Biora Therapeutics, Inc.
All rights reserved.
BT-600 PHASE 1 CLINICAL TRIAL IN HEALTHY PARTICIPANTS Ariella Kelman,
MD Chief Medical Officer Biora Therapeutics
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 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. 11 © 2024 Biora Therapeutics, Inc. All rights reserved.
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 Placebo or BT-600, 7
days/QD 10mg 7x QD n=9 Placebo n=3 MAD 5mg 7x QD n=9 Placebo n=3 Baseline D1 D2 D3 D4 D5 D6 24 subjects D7 D8 Blood Blood Stool Blood & Stool Tissue Total of 48 healthy participants PATIENT POPULATION (24 SAD and 24 MAD participants) Randomized,
double-blind, placebo-controlled clinical trial to evaluate the safety, TRIAL DESIGN tolerability, and PK of SAD and MAD doses of BT-600 in healthy participants 12 © 2024 Biora Therapeutics, Inc. All rights reserved.
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 levels
were 3–4x lower than seen with Xeljanz delivery in the colon • Demonstrated ability to deliver tofacitinib to the colon with lower systemic 1 levels than seen with conventional oral delivery in both SAD/MAD cohorts COLON TISSUE EXPOSURE
• After delivery to the proximal colon, tofacitinib was detected across multiple Pan-colonic drug biopsy sites in the distal colon delivery • Delivery and distribution of tissue exposure consistent with delivery to the entire colon
• Modeling projects tissue levels at or above the estimated IC90 across all three biopsy sites through at least 16 hours DEVICE FUNCTION • >95% of devices successfully detected colon entry Accurately delivered to the colon SAFETY
& TOLERABILITY • BT-600 was well tolerated by participants in SAD and MAD cohorts Showed safety of daily administration Phase 1 clinical trial 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. 13 © 2024 Biora Therapeutics, Inc. All rights
reserved.
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 previously observed in human device function studies SOFTWARE ANALYSIS OF POST-DOSE RETRIEVED NAVICAP DEVICES SAD MAD Devices identified colon entry 24/24 (100%) 156/162 (96%) S4 call Mean time of colon entry, hours 5.6 (2.1) 6.6 (3.2)
post dose (SD) Mean T , hours post dose (SD) 6.9 (2.6) 6.9 (2.0) first Phase 1 clinical trial data on file, Biora Therapeutics, Inc. 1. Lee SN, Razag G, Kelly C, et al. Results of human device function studies for the NaviCap Targeted Oral Delivery
Platform in healthy volunteers and patients with UC. Poster presented at: Digestive Disease Week, May 18 – 21, 2024, Washington DC. 14 © 2024 Biora Therapeutics, Inc. All rights reserved.
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. Phase 1
clinical trial data on file, Biora Therapeutics, Inc. 2. 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 NOTE: 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. Plasma tofacitinib conc. (ng/mL)
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 first
(4–16) (4–10) 10 8 10 8 1.0 0.5 T hours max ‡ (4–10) (4–12) (6–12) (6–10) (0.5–14.0) (0.25–1.0) C ng/mL 11.3 (97) 24.2 (27) 11.3 (39) 16.3 (77) 42.7 (26) 88 (10.2) max AUC ng.hr/ml 92.8 (61)
194.0 (21) 115.8 (33) 140.5 (91) 263.4 (15) 283 (80) 0-24 † Values for T and T represent median (range). Values for C and AUC represent geometric mean (CV), except Xeljanz single-dose results which represent arithmetic mean (SD). first max max
0-24 ‡ T range excludes one device that did not release payload. max 1. Phase 1 clinical trial data on file, Biora Therapeutics, Inc. 2. Pfizer, Inc. Xeljanz (tofacitinib) USPI. https://labeling.pfizer.com/showlabeling.aspx?id=959 Revised May
2024. Accessed June 18, 2024. 3. 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. NOTE:
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. 16 © 2024 Biora Therapeutics, Inc. All rights reserved.
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 7
days 20 10 0 0 12 24 36 48 60 72 84 96 108 120 132 144 156 168 180 192 Time (HR) Time (hr) 1. Phase 1 clinical trial data on file, Biora Therapeutics, Inc. 17 © 2024 Biora Therapeutics, Inc. All rights reserved. Tofacitinib conc. (ng/mL) BT-001
Concentration (ng/mL)
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 15/18 biopsies 144 156
168 180 Time (HR) SIGMOID COLON ASCENDING COLON tofacitinib present in oral enema biopsy day 7 payload area of payload release 14/18 biopsies dose release laxative • Drug measured in tissue across distal colon sites (following proximal payload
delivery) consistent with pan-colonic delivery • Colon tissue absorption demonstrated despite: • Long dose-to-biopsy latency at ≈24 hours (and five half-lives) since final dose • Pre-procedural bowel prep with oral and rectal
laxatives • Healthy participants (vs. UC patients who may have enhanced colonic absorption during active disease) Phase 1 clinical trial data on file, Biora Therapeutics, Inc. 18 © 2024 Biora Therapeutics, Inc. All rights reserved.
Tofacitinib conc. (ng/mL) BT-001 Concentration (ng/mL)
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 across
all 3 biopsy sites at ≈24 hours (5 half lives) post dose • Correlation between plasma and tissue levels was used to model tissue levels at earlier time points Phase 1 clinical trial data on file, Biora Therapeutics, Inc. 19 © 2024
Biora Therapeutics, Inc. All rights reserved.
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 Sigmoid
Concentration Median for both Post Last Dose Flexure Colon Colon ng/mL groups = 520 ng/g ng/g ng/g ng/g Median tissue exposure 22–26 hours tissue 338 159 161 20 hours plasma 3.0 IC = 823 ng/g (28, 649) (96, 223) (72, 251) 90 (measured, n=15)
16 hours 10 Range 3,000 – 10,000 ng/g ‡ projected Non-responders Responders † Values represent mean (95% confidence interval) ‡ Predicted tissue levels geometric means based on plasma drug level at 16 hours after device
ingestion Endoscopic improvement by week 16, P=0.04 for group comparison • Tofacitinib tissue concentrations shown to correlate with endoscopic response, with responders having a median tissue concentration above the estimated IC90 •
Projected tofacitinib levels above IC90 through at least 16 hours, with measured levels above IC50 at 24 hours post dose • NaviCap delivery predicted to enable tissue concentrations associated with improved efficacy with lower systemic
exposure 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.
Phase 1 clinical trial data on file, Biora Therapeutics, Inc. 20 © 2024 Biora Therapeutics, Inc. All rights reserved.
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
laboratory parameters between groups LDL CHOLESTEROL NEUTROPHILS MEAN CHANGES FROM BASELINE (MAD) MEAN CHANGES FROM BASELINE (MAD) BT600: Mean Change from Baseline in BT600: Mean Changes from Baseline in LDL Cholesterol (MAD) Neutrophil (MAD) 1.0 1
Placebo, QD Placebo, QD 5 mg, QD BT-600 5 mg, QD BT-600 0 x7 days x7 days 0.5 3 4 5 6 7 -1 10 mg, QD BT-600 10 mg, QD BT-600 x7 days x7 days 0.0 -2 3 4 5 6 7 -0.5 -3 Time (Days) Time (Days) Phase 1 clinical trial data on file, Biora Therapeutics,
Inc. 21 © 2024 Biora Therapeutics, Inc. All rights reserved. LDL Cholesterol Level (mmol/L) Neutrophil Counts 9 (10 /L)
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 delivered via
NaviCap Population Population Population ≈15 UC patients ≈150 UC patients 48 healthy participants Design Design Design Single-center trial Global multicenter induction efficacy trial Single-center SAD/MAD trial Endpoints Endpoints
Endpoints • Safety & tolerability • Clinical and endoscopic response • Safety & tolerability • PK/PD • Mucosal healing • PK/PD • Device function • PROs • Device function •
Biomarkers PLANNED START: Q4 2024 PLANNED START: Q4 2025 COMPLETE DURATION: 6 MO DURATION: TBD 22 © 2024 Biora Therapeutics, Inc. All rights reserved.
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.
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 enemas and
suppositories in severe refractory disease Inability to sufficiently reach colon tissue may limit efficacy of systemic treatments • Doses needed to achieve sufficient colon tissue exposure are limited by toxicity risks • Precise topical
delivery could result in improved tissue exposure with lower systemic absorption 24 © 2024 Biora Therapeutics, Inc. All rights reserved.
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 polymers, enzyme sensitive systems • Highly variable delivery in colon, often disintegrate in upper GI tract or 1 are retrieved intact 2 • Limited drug exposure in the distal colon, especially in UC • Often require
solid-dose formulations which need solubilization UC: 91% (proximal) vs. 9% (distal) in the colon, limiting uptake Healthy: 69% (proximal) vs. 31% (distal) • Reliant on variable GI conditions including pH, motility, water content, and
bacterial enzymes 1. Ibekwe, V.C., Fadda, H.M., McConnell, E.L. et al. Interplay Between Intestinal pH, Transit Time and Feed Status on the In Vivo Performance of pH Responsive Ileo-Colonic Release Systems. Pharm Res 25, 1828–1835 (2008). 25
©2. 20H 24 e bde Biorn a J T M h, e B ra la pe ck u s th ic a sw , I n Pc E. , A Pl e l rrk ig in hs t s A r C e,s W eri v le so d. n CG, Spiller RC. Limited exposure of the healthy distal colon to orally-dosed formulation is further
exaggerated in active left-sided ulcerative colitis. Aliment Pharmacol Ther. 2000 Feb;14(2):155-61.
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 endoscopic
improvement by week 16 (p=0.04) 2 ANTI-TNF TISSUE EXPOSURE HIGHER IN ENDOSCOPIC RESPONDERS 30 UC patients on active maintenance therapy with REMICADE (infliximab) or HUMIRA (adalimumab) with tissue < blood and endoscopic assessment • While
there was a correlation between serum and tissue drug levels, areas of tissue with active inflammation acted as a sink for the anti-TNF antibody • The ratio of anti-TNF to TNF cytokine levels was higher in patients in endoscopic remission
Figure 4: Mean drug to tumour necrosis factor (TNF) ratios in tissue with none, mild, moderate and severe inflammation (n.s., not significant). 3 VEDOLIZUMAB TISSUE EXPOSURE HIGHER IN ENDOSCOPIC RESPONDERS 37 IBD patients with active endoscopic
disease Tx with ENTYVIO (vedolizumab) and prospectively monitored • Patients with endoscopic remission or response had significantly higher tissue drug levels (p=0.04) • Authors suggest targeting vedolizumab tissue levels to optimize Tx
in patients with no or loss of response 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. 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 26 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 © 2024 Biora Therapeutics, Inc. All rights reserved.
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: 3094 ng/g ρ =
0.92 ρ = 0.92 p < 0.001 p < 0.001 Plasma Concentration (ng/mL) • Correlation between plasma and tissue levels was used to model tissue levels at earlier time points • NaviCap colonic delivery achieves higher tissue to plasma
concentration ratio at lower dose • Potential for improved efficacy with tissue exposure above IC90, with lower systemic absorption 1. Verstockt B., et al., . Tofacitinib tissue exposure correlates with endoscopic outcome. Poster presented at:
Digestive Disease Week, May 21, 2022, virtual. 27 2. Phase 1 clinical trial data on file, Biora Therapeutics, Inc. © 2024 Biora Therapeutics, Inc. All rights reserved. Tissue Concentration (ng/g)
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 Reliable delivery
in the colon, rather than the ü No early releases in BT-600 Phase 1 trial upper GI tract 3. TISSUE EXPOSURE Tissue exposure along the length of the ü Demonstrated in BT-600 Phase 1 trial colon and in NaviCap scintigraphy device function
studies 28 © 2024 Biora Therapeutics, Inc. All rights reserved.
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 classes 30 © 2024 Biora Therapeutics, Inc. All rights reserved.
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