All pharmacokinetic endpoints were achieved, with a PK profile consistent with drug delivery and absorption in the colon All NaviCap™ devices performed as intended and were well tolerated, with no safety signals observed Multiple-ascending dose (MAD) portion of the trial is underway and progressing well SAN DIEGO, April 04, 2024 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (NASDAQ:BIOR), the biotech company that is reimagining therapeutic delivery, today shared additional positive interim results from the ...

SAN DIEGO, April 03, 2024 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (NASDAQ:BIOR), the biotech company that is reimagining therapeutic delivery, today announced the closing of its previously announced registered direct offering of an aggregate of 5,454,548 shares of the Company's common stock at an offering price of $1.10 per share of common stock and concurrent private placement of unregistered warrants to purchase up to 5,454,548 shares of common stock. The warrants have an exercise price of $1.10 per ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 67 Item 6. Reserved 67 Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations 68 Item 7A. Quantitative and Qualitative Disclosures About Market Risk 75 Item 8. Financial Statements and Supplementary Data 76 Item 9. Changes in and Disagreements With Accountants on Ac ...

Biora Therapeutics, Inc. (NASDAQ:BIOR) Q4 2023 Results Conference Call March 26, 2024 4:30 PM ET Company Participants Chuck Pedala - LifeSci Advisors Adi Mohanty - CEO Ariella Kelman - Chief Medical Officer Eric d'Esparbes - CFO Conference Call Participants John Vandermosten - Zacks Investment Research Operator Welcome to the Biora Therapeutics Fourth Quarter 2023 Financial Results Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow a formal presen ...

Biora Therapeutics Provides Corporate Update and Reports Fourth Quarter and Full-Year 2023 Financial Results Results demonstrated targeted drug delivery and absorption in the colon, with 3-4 times lower drug levels in blood SAN DIEGO, March 26, 2024 – Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that is reimagining therapeutic delivery, today provided a corporate update and reported financial results for the fourth quarter and year ended December 31, 2023. Exhibit 99.1 All performance target ...

Monetization of legacy asset brings in $3 million in nondilutive capital Convertible notes exchange brings in another $2.8 million in new capital and reduces Biora's net debt SAN DIEGO, March 11, 2024 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (NASDAQ:BIOR), the biotech company that is reimagining therapeutic delivery, today announced an agreement with institutional investor Context Capital to invest $2.8 million in new capital alongside a convertible note exchange, and announced the monetization of its ...

SAN DIEGO, Feb. 08, 2024 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (NASDAQ:BIOR), the biotech company that is reimagining therapeutic delivery, today announced it will participate in the Inflammatory Bowel Disease Symposium hosted virtually by Canaccord Genuity Capital Markets on Wednesday, February 28, 2024. Ariella Kelman, M.D., Chief Medical Officer, will participate in the panel titled "The Next Evolutionary Steps in Addressing IBD," beginning at 10:00 AM Eastern / 7:00 AM Pacific time. Interested pa ...

Financial Data and Key Metrics Changes - Operating expenses for Q3 2023 were $23.3 million, up from $14.9 million in Q2 2023, primarily due to a one-time stock-based compensation charge of approximately $9 million [32][45] - The net loss for the quarter was $73.5 million, which included non-cash charges of $9 million for stock-based compensation and $53.2 million related to the convertible note exchange [45][32] - The effective operating cash burn for the quarter was $12.7 million, with an average monthly operating cash burn maintained at approximately $4 million [45][32] Business Line Data and Key Metrics Changes - The NaviCap platform is on track to initiate a Phase 1 clinical trial by the end of 2023, with initial data expected early next year [15][60] - The BioJet platform has shown promising results in animal studies, with 96% of animals demonstrating systemic circulation of semaglutide at clinically relevant levels [11][12] - The company is actively negotiating with a fourth pharma collaborator for the BioJet platform, indicating increasing interest from potential partners [13][66] Market Data and Key Metrics Changes - The company has successfully raised nearly $6 million in gross proceeds through various sources since the last call, including monetizing legacy assets [36] - The company continues to target non-dilutive funding sources and is engaged with the investor community to secure necessary capital for program development [36] Company Strategy and Development Direction - The company aims to expand its intellectual property coverage for the NaviCap platform, having received a notice of allowance for a new patent related to the BT-600 program [8][25] - The BioJet platform is positioned to provide needle-free oral delivery of therapeutic molecules, with ongoing development and testing of the next-gen BioJet 2 device [10][26] - The company is focused on progressing its collaborations with pharma partners to generate data that could lead to meaningful partnerships in the future [55][66] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the FDA's review process for the BT-600 IND application, anticipating clearance in November and trial initiation in December [51][60] - The company is preparing for the Phase 1 trial by ensuring all necessary materials and protocols are in place, indicating readiness to proceed upon FDA clearance [70][63] - Management noted that the collaborations with pharma partners are yielding positive results, which could accelerate interest and lead to more partnerships [66][55] Other Important Information - The company has a comprehensive IP portfolio for drug delivery using ingestible devices, with 30 patent families for the NaviCap platform alone [25] - The company is actively working to reduce its convertible note balance, having already reduced it by $50 million through a note exchange agreement [31] Q&A Session Summary Question: Update on BT-600 IND and study initiation - Management clarified that the IND resubmission was tactical, providing additional information to the FDA, and they expect a standard 30-day review process [60][81] Question: Readiness for Phase 1 program - Management confirmed that all necessary preparations for the Phase 1 trial are on track, including site readiness and material supply [70][63] Question: Timeline for BioJet partnerships - Management indicated that data generation from ongoing studies will facilitate discussions for potential partnerships, with a focus on translating research collaborations into meaningful partnerships [55][66]

Biora Therapeutics, Inc. (Exact name of registrant as specified in its charter) UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 001-39334 Delaware 27-3950390 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 4330 La Jolla Village Drive, Suite 300, San Diego, CA 92122 Registrant's telephone number, including a ...

Financial Data and Key Metrics Changes - Operating expenses excluding stock-based compensation remained stable at $12.5 million, with G&A expenses at $7.7 million and R&D expenses at $5.2 million for Q2 2023 [28][56] - The company raised $8 million in gross equity proceeds during Q2, leading to a slight reduction in cash balance to $26.5 million as of June 30, 2023 [56] Business Line Data and Key Metrics Changes - The NaviCap platform is on track for an IND filing in September, with a focus on the BT-600 program for ulcerative colitis [51][54] - The BioJet platform aims to provide needle-free, oral delivery of large molecules, with ongoing development and testing of the next-generation device [9][10] Market Data and Key Metrics Changes - The BioJet platform is positioned to participate in the $100 billion plus GLP-1 agonist market, with approximately 38 issued patents and pending applications [11] - The company is focused on addressing the unmet needs in ulcerative colitis, which has seen significant business transactions worth billions in recent years [35] Company Strategy and Development Direction - The company aims to transform treatment options for various GI diseases through the NaviCap platform, while the BioJet platform is expected to enhance patient compliance and outcomes [8][9] - The strategy includes leveraging collaborations with large companies to establish the BioJet platform's capabilities [46][72] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the progress towards the IND filing for the NaviCap program and the potential to address significant unmet needs for UC patients [51][62] - The company anticipates initiating the Phase 1 trial for the NaviCap platform before the end of the year, with a focus on confirming device performance and safety [54][56] Other Important Information - The NaviCap device demonstrated over 90% performance in identifying entry into the colon and triggering the release of its payload [6][19] - The company has strengthened its intellectual property position with new patents related to the NaviCap device and its applications in treating ulcerative colitis [23][8] Q&A Session Summary Question: How soon could dosing in ulcerative colitis patients proceed? - Management indicated that they have already conducted studies with UC patients and are confident in the device's performance, expecting to propose a patient study soon after Phase 1 data is gathered [37][38] Question: What are the differences to consider for the Phase 1 BT-600 initiation? - Management confirmed that the biopsy at the end of the study is manageable and will not significantly impact execution goals, with FDA interactions being supportive [41][42] Question: What primary endpoints does the FDA anticipate for the pivotal trial? - Management noted that typical UC trial outcomes are well established, and they expect to demonstrate comparative data easily due to the extensive existing data [45][70]