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Biora Therapeutics, Inc. (Nasdaq: BIOR) is a pioneering biotechnology company focused on revolutionizing therapeutic delivery methods. Headquartered in San Diego, Biora Therapeutics is at the forefront of developing innovative oral biotherapeutics designed to transform patient care. The company is primarily working on two advanced platforms: the NaviCap™ targeted oral delivery platform and the BioJet™ systemic oral delivery platform.
The NaviCap™ platform is tailored for the precise delivery of therapeutics directly to disease sites within the gastrointestinal (GI) tract. This approach aims to enhance treatment outcomes for patients with inflammatory bowel disease (IBD) by increasing therapeutic levels in the affected tissues while minimizing systemic absorption. Notably, Biora's BT-600, a drug-device combination that uses the NaviCap™ device to deliver a unique liquid formulation of tofacitinib, is being developed for the treatment of ulcerative colitis. The positive results from clinical trials highlight the platform's potential to deliver medication specifically to the colon, potentially leading to higher drug efficacy and reduced toxicity.
The BioJet™ platform is designed to replace traditional injections with needle-free, oral delivery of large molecules. This systemic oral delivery system promises to improve chronic disease management by making drug administration more patient-friendly and efficient. The BioJet™ device, roughly the size of a multivitamin, autonomously delivers liquid drugs directly into the small intestine, ensuring optimal drug absorption and bioavailability without the need for complex reformulation.
Financially, Biora Therapeutics has demonstrated resilience and strategic progress. For the fourth quarter of 2023, the company reported a net loss of $15.4 million, a significant improvement from the previous quarter's loss of $73.5 million. This reduction was primarily due to non-recurring charges in the third quarter. Furthermore, the company's operating expenses decreased to $13.3 million in Q4 2023 from $23.3 million in Q3 2023. Biora also successfully raised approximately $6 million through a stock offering, which will support ongoing clinical trials and platform development.
Recent achievements include the issuance of a new patent by the U.S. Patent and Trademark Office, strengthening Biora's intellectual property portfolio for the BioJet™ platform. The company is actively pursuing collaborations and partnerships to further advance its innovative platforms and bring new treatments to market.
With a clear focus on improving patient outcomes and a robust pipeline of innovative products, Biora Therapeutics is poised to make significant strides in the biotechnology sector.
For more information, visit bioratherapeutics.com or follow the company on LinkedIn and Twitter.
Biora Therapeutics (Nasdaq: BIOR) announced its participation in the IBD Innovate event on April 26, 2023, in New York City. The event will center on innovative product development in inflammatory bowel disease (IBD). Biora's Head of Strategy, Chris Wahl, will present on the NaviCap™ targeted oral delivery platform, which aims to enhance outcomes for ulcerative colitis patients by delivering therapies directly to disease sites, minimizing systemic toxicity.
The NaviCap device is an ingestible medical tool designed to autonomously release therapeutic doses in the gastrointestinal tract. Biora's BT-600 program uses this device to deliver a liquid formulation of tofacitinib for ulcerative colitis. Successful studies have demonstrated the device's localization capabilities and its potential as the first non-fasting ingestible delivery system. Biora aims to submit an IND application for Phase 1 trials.
Biora Therapeutics (Nasdaq: BIOR) provided a corporate update and financial results for the fourth quarter and full year ended December 31, 2022, announcing new brand names for its delivery platforms: NaviCap™ for oral delivery and BioJet™ for systemic delivery. The company achieved a significant milestone by completing a 14-day toxicology study for its BT-600 program, reporting no adverse events. Biora also announced impressive bioavailability results in preclinical studies, surpassing its target with an average of 37% for semaglutide and 51% for adalimumab. The company raised $12.9 million through its ATM program, while operating expenses decreased from the previous year.
Biora Therapeutics (Nasdaq: BIOR) will report its fourth quarter and full year financial results for the period ending December 31, 2022, on March 30, 2023, post-market close. A webcast and conference call will follow at 4:30 PM ET to discuss the results and provide corporate updates. Biora focuses on innovative therapeutic delivery solutions, including smart pills for targeted drug delivery and needle-free biotherapeutics. The company aims to enhance patient care through advanced therapeutic options.
Biora Therapeutics (Nasdaq: BIOR) announced promising preclinical data for its PGN-OB2 program, showcasing an average bioavailability of 37% for semaglutide, significantly higher than the current oral formulation's less than 1%. Utilizing liquid jet technology in porcine models, the results suggest strong potential for oral delivery of peptides and monoclonal antibodies. This aligns with the company’s goal of exceeding a 15% bioavailability target. With broad patent protection and a commitment to advancing their systemic delivery platform, Biora plans further preclinical studies in 2023 to enhance and commercialize this innovative delivery method.
Biora Therapeutics has announced promising preliminary results from its preclinical research on the PGN-OB1 program, demonstrating an average bioavailability of 51.3% for a variant of adalimumab, a result achieved using their novel liquid jet delivery technology. This marked improvement not only surpasses previous performance metrics but also shows consistent results comparable to traditional subcutaneous administration. The study evaluated a 56 mg dose in a porcine model, with the device expected to enhance future collaborations in the pharmaceutical sector. Biora possesses a robust patent portfolio with approximately 34 patents related to its delivery methods.
Biora Therapeutics (Nasdaq: BIOR) has presented promising results from its PM-611 study on a novel Drug Delivery System (DDS) that demonstrated effective functioning with food intake. Conducted with healthy volunteers, the study suggests potential for non-fasted administration of the PGN-600 device, enhancing convenience for patients. CEO Adi Mohanty noted the importance of these findings for treating ulcerative colitis and other diseases. The study, involving 12 participants and 46 device administrations, reported no serious adverse events. Biora plans to file an IND application in the first half of 2023 to initiate further clinical trials.
Biora Therapeutics announced progress in its clinical development plan for the PGN-600 program, focusing on ulcerative colitis. With feedback from the FDA, the company plans to file an IND and begin clinical trials in the first half of 2023. Data readouts are anticipated by Q3. The company is also advancing its Systemic Therapeutics program, expecting to report preclinical data soon. Biora’s innovative delivery systems aim to enhance therapeutic efficacy for patients with IBD, targeting improved drug delivery while minimizing systemic exposure.
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