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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 presented significant findings at the Controlled Release Society 2022 Annual Meeting on their Oral Biotherapeutics Delivery System (OBDS). Preclinical studies highlighted a monoclonal antibody bioavailability of up to 55% in animal models, demonstrating functionality with a range of 25% on average. The OBDS was successfully administered through endoscopy, showing effective release in the small intestine. These advancements suggest a promising alternative to current injection methods, aiming for human clinical trials in late 2022.
Biora Therapeutics (Nasdaq: BIOR) announced positive topline results from its PM-611 study, assessing the functionality of its Drug Delivery System (DDS) Capsule. The study confirmed safe ingestion and functionality under both fed and fasted conditions, with no serious adverse events. All analyzed capsules demonstrated successful colon entry and deployment. CEO Adi Mohanty highlighted that this could mark the first ingestible therapeutic device usable with food, benefiting patients with chronic conditions like ulcerative colitis. The company anticipates announcing results from its third clinical study in Q3 2022.
Biora Therapeutics (BIOR) has announced that an abstract detailing its innovative systemic therapeutics delivery system has been accepted for presentation at the Parenteral Drug Association (PDA) conference, taking place on October 18-19, 2022, in Palm Springs, California. The abstract, titled 'Development of a Submucosal Injection Device for an Oral Biotherapeutic Delivery System,' will highlight advancements in autonomous triggering and injection efficiency. The poster presentation will also be available on the Biora Therapeutics website post-conference.
Biora Therapeutics presented a significant oral study at Digestive Disease Week 2022, emphasizing the relationship between tofacitinib tissue levels and endoscopic outcomes in patients with ulcerative colitis. Key findings indicate that tissue concentration correlating with better patient outcomes supports the company's targeted delivery platform. CEO Adi Mohanty highlighted plans for a phase 1 clinical study and the potential of combination therapy to enhance treatment for patients lacking options. The company focuses on innovative smart pills for targeted drug delivery.
Biora Therapeutics (Nasdaq: BIOR) presented new data during Digestive Disease Week 2022, indicating significant findings in the treatment of ulcerative colitis (UC). A study revealed high levels of the pro-inflammatory cytokine IL6 in UC patients, suggesting potential limitations of existing anti-TNF therapies and the need for combination treatments targeting multiple inflammatory pathways. Additionally, Biora showcased its Recoverable Sample System capsule designed for precise microbiome sampling, which may enhance the understanding of intestinal conditions. These innovations could lead to improved therapeutic outcomes for UC patients.
Biora Therapeutics has announced significant advancements in its Drug Delivery System (DDS) platform, securing 29 patents globally for its ingestible device localization technology. This includes U.S. Patent No. 10,835,152, which focuses on an electromechanical pill for localized drug delivery in the GI tract. The technology aims to enhance the treatment of conditions like inflammatory bowel disease (IBD) by targeting therapeutics directly to affected areas, mitigating systemic toxicity. A clinical trial is underway, and Biora's extensive patent portfolio reinforces its innovative capabilities.
Biora Therapeutics (Nasdaq: BIOR) announced its participation in the H.C. Wainwright Global Investment Conference from May 23 to 26, 2022, at the Fontainebleau Hotel in Miami, Florida. The management team will give a corporate overview and hold one-on-one meetings with attendees. The presentation is scheduled for May 24, from 3:00 PM to 4:00 PM Eastern Time. Interested individuals can access the webcast through Biora's website, with replays available for 60 days. Biora is focused on innovative therapeutics, including smart pills for targeted drug delivery.
Biora Therapeutics, Inc. (Nasdaq: BIOR) has transformed its identity with the launch of Biora Therapeutics, focusing on oral therapeutic solutions. The company reported $1.4 million in revenues for Q1 2022, down from $7.7 million in Q4 2021, with a net loss of $13.8 million. Operating expenses decreased to $20.0 million, compared to $31.6 million a year prior. The company aims to enhance treatment for ulcerative colitis through innovative drug delivery systems. Biora raised $3.7 million via its ATM program and strengthened leadership with the addition of Paul Shabram.