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Biora Therapeutics, Inc., formerly known as Progenity, Inc., is a clinical-stage biotechnology company focused on developing oral drug delivery technologies for gastrointestinal diseases and biologic therapies. The company operates two proprietary platforms: NaviCap for targeted delivery within the digestive tract and BioJet for systemic delivery of large molecule drugs.
Important Status Update: In December 2024, Biora Therapeutics filed for Chapter 11 bankruptcy protection. The company completed its restructuring and emerged in March 2025 as a privately held entity. Existing common shares were cancelled, and the company is no longer publicly traded on any stock exchange.
The NaviCap platform utilizes an ingestible capsule equipped with autolocation technology to deliver therapeutics directly to specific locations in the gastrointestinal tract. The lead program, BT-600, combines the NaviCap device with a liquid formulation of tofacitinib for treating moderate to severe ulcerative colitis. Clinical trials have evaluated the device's ability to localize within the colon and release medication at the intended site.
The BioJet platform aims to enable needle-free oral delivery of biologic drugs through liquid jet injection technology contained within a swallowable capsule. Development programs include BT-002, which delivers an adalimumab variant for inflammatory conditions, and BT-200, which delivers a GLP-1 receptor agonist for type 2 diabetes management. The company has established research collaborations with pharmaceutical partners to advance this technology.
Biora Therapeutics maintains an extensive intellectual property portfolio with over 30 patent families covering both platforms. The company's technology addresses challenges associated with delivering adequate drug concentrations to disease sites while minimizing systemic exposure and side effects. News related to Biora may cover clinical trial results, regulatory developments, partnership announcements, and advances in oral drug delivery technology.
Biora Therapeutics (Nasdaq: BIOR) announced five poster presentations at the ACG 2022 Annual Scientific Meeting, showcasing results from clinical trials on its Drug Delivery System (DDS) platform. Key findings indicate the DDS was well tolerated, effectively localized, and delivered therapeutics in patients with ulcerative colitis. The results highlight the potential of targeted drug delivery to improve treatment outcomes for the 1.8 million IBD patients in the U.S. The company is developing the PGN-600 program, which uses DDS to deliver tofacitinib for ulcerative colitis treatment.
Biora Therapeutics presented a poster at the PDA Universe Conference, showcasing their innovative delivery system for large molecules. This system employs submucosal liquid jet injection targeted at the small intestine, aiming to optimize oral drug delivery. In preclinical studies, the device demonstrated over 83% deployment accuracy in canines, with a notable oral bioavailability of 25% for a variant of adalimumab in swine. Biora is advancing its PGN-OB2 program for type 2 diabetes treatment, emphasizing the importance of oral administration for patient adherence.
Biora Therapeutics (Nasdaq: BIOR) announced its participation in the 12th annual Partnership Opportunities in Drug Delivery (PODD) Conference on October 24-25, 2022, in Boston. Chris Wahl, MD, will discuss advancements in oral drug delivery of macromolecules, highlighting challenges and innovations in the field. Biora's systemic therapeutics platform utilizes a smart ingestible capsule designed for effective oral delivery of biotherapeutics, including monoclonal antibodies and peptides, aiming to improve patient outcomes, particularly for inflammatory bowel disease (IBD) sufferers.
Biora Therapeutics has announced the issuance of a new patent by the USPTO for the oral, systemic delivery of GLP-1 receptor agonists via a specialized ingestible device. This patent, U.S. Patent No. 11,439,802, supports their PGN-OB2 program aimed at treating type 2 diabetes. With a potential market exceeding $20 billion for GLP-1 receptor agonists by 2025, Biora aims to enhance bioavailability significantly beyond the current 1% of available oral medications. The company bolsters a strong patent portfolio with 82 families, ensuring robust intellectual property for its innovative technologies.
Biora Therapeutics (Nasdaq: BIOR) announced the appointment of Dr. Bruce Sands as chair of its Clinical Advisory Board for Inflammatory Bowel Disease (IBD). Dr. Sands is a prominent figure in IBD research, joining experts like Dr. Geert D’Haens and Dr. Brian Feagan. The advisory board will offer strategic guidance for Biora’s Targeted Therapeutics pipeline, which aims to enhance drug delivery for IBD patients. Dr. Sands emphasized the potential of targeted delivery methods to improve therapeutic outcomes. Biora’s innovations aim to address the limitations of current treatment options.
Biora Therapeutics (Nasdaq: BIOR) announces its participation in the H.C. Wainwright 24th Annual Global Investment Conference in New York City from September 12-14, 2022. The management team will present and hold one-on-one meetings with investors. Biora focuses on innovative therapeutics, including smart pills for drug delivery to the GI tract and needle-free biotherapeutics. The company aims to enhance patient outcomes through accessibility to advanced therapeutic solutions. Interested investors can schedule meetings through their H.C. Wainwright contacts.
Biora Therapeutics, Inc. (Nasdaq: BIOR) announced the completion of significant human studies showcasing the effectiveness of its targeted therapeutics platform. The PM-602 study demonstrated positive results in active ulcerative colitis patients, while the PM-611 study confirmed the device's performance in healthy volunteers without food restrictions. The FDA provided constructive feedback on the PGN-600 clinical trial design, with an IND filing expected in Q1 2023. Financially, Q2 2022 revenues totaled $0.9 million, with a reduced net loss of $5.5 million, marking a significant improvement from the previous year's loss.
Biora Therapeutics has announced successful results from its study PM-602, demonstrating that its drug delivery system capsule effectively detects colon entry in patients with active ulcerative colitis. The study involved seven patients and indicated the device's ability to release its payload across the entire colon. The CEO highlighted the significance of these findings as they support the advance of the PGN-600 clinical program. The Drug Delivery System aims to improve therapeutic outcomes for inflammatory bowel disease by precisely targeting drug delivery.
Biora Therapeutics (Nasdaq: BIOR) announced that five abstracts will be presented at the American College of Gastroenterology (ACG) 2022 Annual Scientific Meeting from October 21–26, 2022. The presentations focus on their Targeted Therapeutics Platform and Systemic Therapeutics Platform, including device performance studies and preclinical data. Notable presentations will be led by key researchers, including Shaoying Nikki Lee, PhD. The research aims to advance the treatment of gastrointestinal disorders and will be published in The American Journal of Gastroenterology.
Biora Therapeutics (Nasdaq: BIOR) announced participation in one-on-one meetings at the BTIG Biotechnology Conference, held virtually and at the St. Regis New York Hotel on August 8-9, 2022. The company focuses on innovative drug delivery systems, particularly smart pills for targeted gastrointestinal treatment and needle-free biotherapeutics. Interested parties can schedule meetings through BTIG representatives. Biora aims to enhance patient care through advanced therapeutic solutions.