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Biora Therapeutics (formerly trading under the symbol BIOR) has generated frequent news coverage around its development of smart pill-based therapeutic delivery platforms and its corporate restructuring. Company releases describe Biora as a clinical-stage biotech focused on two main platforms: NaviCap, for colon-targeted treatment of inflammatory bowel disease, and BioJet, a swallowable autoinjector platform for oral delivery of large molecules designed to replace injection with needle-free, oral administration.
News items detail progress on the BioJet™ Oral Delivery Platform, including development of a smaller, 00-size device with increased payload capacity compared with a larger 000-size capsule. Biora reports that the 00-size BioJet device is designed to deliver standard liquid drug formulations with a capacity greater than 300 microliters and to enable doses greater than 50 milligrams. Releases also describe in vivo studies, work with collaborator molecules, and presentations at industry meetings such as the Partnership Opportunities in Drug Delivery meeting and the Peptide Therapeutics Symposium.
Another major theme in Biora’s news flow is the NaviCap™ platform and its application to inflammatory bowel disease. The company has announced Phase 1 clinical trial data for BT-600, a NaviCap-based program, presented at a leading gastroenterology conference and recognized with a Presidential Poster Award, with the results suggesting the potential for larger clinical trials in ulcerative colitis patients.
In addition to R&D updates, Biora’s news includes financing transactions, Nasdaq listing developments, and a chapter 11 filing in the District of Delaware as part of a court-supervised sale process. Subsequent news reports the completion of this restructuring, with Biora emerging as a privately held company and its existing common shares cancelled pursuant to a Plan of Reorganization. Readers following BIOR-related news can review this sequence of scientific, clinical, financial, and restructuring announcements to understand the company’s evolution and platform development.
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.
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.