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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 a reverse stock split of its common stock at a ratio of 25 to 1, effective January 3, 2023. This decision was approved by stockholders on December 19, 2022, aimed at meeting Nasdaq’s minimum listing price requirements. Post-split, the total number of authorized shares will reduce from 350 million to 164 million. Stockholders will not experience a change in their percentage interest, except for those entitled to fractional shares, who will receive a cash payment. More details are available in the company’s SEC filings.
Biora Therapeutics (Nasdaq: BIOR) announced the acceptance of two abstracts for presentation at the upcoming Crohn’s & Colitis Congress scheduled for January 19-21, 2023, in Denver, Colorado. The abstracts focus on the company's innovative drug delivery system aimed at improving treatment outcomes for ulcerative colitis and other gastrointestinal conditions. Presentations will be made by Dr. Shaoying Nikki Lee, showcasing potential effects of food on this novel delivery system and its efficacy in targeting the colonic mucosa.
Biora Therapeutics has entered a licensing agreement with Avero Diagnostics to commercialize the Preecludia rule-out test for preeclampsia. This test aims to provide healthcare providers with a novel screening tool to assess preeclampsia risk based on multi-analyte protein biomarkers. Biora will receive commercial milestone payments and low double-digit royalties on net sales. The partnership is positioned to address unmet needs in prenatal care, with expectations of future revenue generation for Biora.
Biora Therapeutics (Nasdaq: BIOR) reported promising results from a study demonstrating its targeted delivery device's efficacy in active ulcerative colitis patients at the American College of Gastroenterology meeting. The company raised $9.75 million through a registered direct financing, reflecting strong investor commitment. Notably, Biora achieved a key patent for oral GLP-1 receptor agonist delivery, positioning itself in a market projected to exceed $20 billion by 2025. Financially, Q3 revenues were $10 million, largely from discontinued operations, with a net loss of $5.1 million.
Biora Therapeutics (Nasdaq: BIOR) will announce its third-quarter financial results for the period ending September 30, 2022, on November 14, 2022. A conference call is scheduled for 4:30 PM Eastern time to discuss these results and provide a corporate update. Investors can participate by phone or via a live webcast on the company's Investor Relations website. Biora is focused on developing innovative therapeutic delivery methods, including needle-free options for patients, aiming to enhance treatment accessibility and effectiveness.
Biora Therapeutics (Nasdaq: BIOR) announced a registered direct offering of 32,506,250 shares and warrants, priced at $0.30 per share, aiming to raise approximately $9.75 million. The offering is set to close around November 9, 2022, subject to customary conditions. Funds will support operations, R&D for oral biotherapeutics, and working capital. An in-kind payment of $3.75 million will also be received via a waiver of a cash interest obligation on Convertible Senior Notes. H.C. Wainwright & Co. is the exclusive placement agent.
Biora Therapeutics, Inc. (Nasdaq: BIOR) has finalized a one-time asset sale agreement with Roche Diagnostics, transferring certain patent rights stemming from its past molecular diagnostics R&D. While financial terms remain undisclosed, the patents relate to methods for identifying the origin of cell-free DNA in bodily fluid samples. This patent family includes several pending and allowed applications in both the U.S. and Europe, addressing crucial health concerns such as fetal fraction, cancer detection, and organ monitoring. CEO Adi Mohanty expressed optimism about Roche's further development of the technology.
Biora Therapeutics presented positive outcomes from its PM-602 study at the ACG 2022 Annual Meeting, showcasing its Drug Delivery System (DDS) for ulcerative colitis patients. The device effectively localized colon entry and released a solution, confirming its potential in enhancing treatment efficacy. Conducted on seven patients, the study indicated the device's ability to deliver therapeutics directly to disease sites, which could improve patient quality of life. An IND application for further clinical studies is expected in Q1 2023, aiming to utilize a tofacitinib formulation.
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.
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