Welcome to our dedicated page for BIORA THERAPEUTICS news (Ticker: BIOR), a resource for investors and traders seeking the latest updates and insights on BIORA THERAPEUTICS stock.
Biora Therapeutics Inc. (BIOR) is a clinical-stage biotechnology company pioneering smart pill-based drug delivery systems for targeted and systemic therapies. This page provides investors and stakeholders with timely updates on the company’s progress in redefining treatment for gastrointestinal diseases and chronic conditions.
Access the latest press releases, clinical trial milestones, and financial reports related to Biora’s innovative platforms—including the NaviCap™ targeted colon release system and BioJet™ needle-free delivery technology. Stay informed about regulatory developments, research collaborations, and strategic partnerships shaping the future of oral biotherapeutics.
This resource is designed for efficient tracking of BIOR’s advancements in drug-device combinations and precision medicine. Bookmark this page or check back regularly for verified updates directly from the company and trusted financial news sources.
Biora Therapeutics has successfully completed its court-supervised restructuring, emerging as a privately held company with improved financial standing. The restructuring resulted in deleveraged debt and significant new financing to support the company's future operations.
The company's ownership has transferred to certain lenders, including Davidson Kempner Capital Management LP, Context Capital Management , and funds managed by Highbridge Capital Management . As part of the reorganization plan, existing common shares were cancelled.
Biora's focus remains on developing the BioJet™ platform, an orally ingestible liquid jet technology capable of delivering over 300 microliters of biologic pharmaceuticals. The company is currently testing an updated 00-size BioJet device while expanding relationships with pharmaceutical collaborators.
Biora Therapeutics has initiated a Chapter 11 bankruptcy process and secured up to $10.25 million in debtor-in-possession financing from its prepetition creditors. The company aims to strengthen its balance sheet through a court-supervised sale process, with the Lenders serving as stalking horse bidders.
The bankruptcy filing in Delaware includes provisions for continuing normal business operations, maintaining employee wages and benefits, and paying vendors and suppliers under normal terms during the Chapter 11 case. The company plans to focus on developing its BioJet and NaviCap platforms through an expedited sale timeline designed to minimize disruption to operations.
Biora Therapeutics provided a Q3 2024 corporate update, highlighting progress on their BioJet device development. The company developed a smaller 00-size device with increased payload capacity, making it the largest in the ingestible injectables category. They shifted strategy from co-development to licensing focus. For NaviCap platform, successful Phase 1 trial of BT-600 may support proceeding directly to a larger clinical trial. Q3 operating expenses were $16.3M, with a net loss of $18.4M. The company received a Nasdaq compliance extension until December 9 and reduced monthly operating expenses by 40% to under $2.5M.
Biora Therapeutics (Nasdaq: BIOR) has announced it will report its third quarter 2024 financial results and provide a corporate update. The company will host a conference call and webcast on Thursday, November 14, 2024, after market close at 4:30 PM Eastern time. Investors can access the call through domestic (1-877-423-9813) or international (1-201-689-8573) numbers using Conference ID 13749254. A webcast replay will be available on the company's website for 60 days.
Biora Therapeutics (Nasdaq: BIOR) has announced a $3 million registered direct offering of 745,342 common stock shares at $4.025 per share, priced at-the-market under Nasdaq rules. The company will also issue unregistered warrants to purchase up to 745,342 shares with a $3.90 exercise price, exercisable upon issuance and expiring in five years. Additionally, Biora will amend existing warrants for 531,162 shares, reducing their exercise price from $11.00 to $3.90 per share. The proceeds will support operations, development of oral biotherapeutics platforms, and working capital. H.C. Wainwright & Co. serves as the exclusive placement agent.
Biora Therapeutics (BIOR) announced progress on its BioJet™ Oral Delivery Platform at the 14th Annual PODD meeting. The company has successfully developed a smaller, 00-size BioJet device that can autonomously deliver medications to the small intestine. The technology has demonstrated >30% oral bioavailability versus intravenous administration in over 30 in vivo studies. The device can deliver doses >50mg, making it the largest payload among ingestible injectables, with capacity now increased to >300 microliters. Testing with existing pharma collaborators is planned for Q4 2024, with molecule-specific feasibility testing in Q1 2025.
Biora Therapeutics (Nasdaq: BIOR) announced that CEO Adi Mohanty will present the company's new 00-size BioJet™ device at the 14th Annual Partnership Opportunities in Drug Delivery (PODD) meeting in Boston, October 28–29, 2024. The company has successfully reduced the device size from 000 to 00 while increasing payload capacity, aligning with strong patient and pharma collaborator preferences.
Mohanty emphasized the significance of this development, describing it as a revolutionary, needleless, liquid injection technology in a smaller, patient-friendly capsule. The presentation, titled 'Solving Drug Delivery Challenges with Ingestible Drug-Device Combinations,' is scheduled for October 28, 2024, at 3:30 PM Eastern Time in the Westin Boston Seaport.
The PODD meeting provides Biora Therapeutics an opportunity to update on their BioJet and NaviCap platforms and engage with existing pharma collaborators as they seek to expand these relationships.
Biora Therapeutics (Nasdaq: BIOR), a biotech company focused on reimagining therapeutic delivery, has announced its participation in the 19th Annual Peptide Therapeutics Symposium. The event will take place both virtually and in-person in La Jolla, California, from October 22-23, 2024.
Dr. Sharat Singh, Head of Research at Biora Therapeutics, will deliver a presentation titled 'Empowering Peptide Self-Administration with Needle Free Smart Capsules' on October 22, 2024, from 2:30 PM to 3:00 PM PT.
The Peptide Therapeutics Symposium is a prestigious gathering of world leaders in peptide research from academia and biopharmaceutical industries. It focuses on advancements in core technology relevant to peptide-based drug discovery and therapeutic candidate development.
Biora Therapeutics (Nasdaq: BIOR) announced an upcoming poster presentation at the American College of Gastroenterology (ACG) Annual Scientific Meeting in Philadelphia, October 25–30, 2024. The company's submission was awarded a Presidential Poster Award, a distinction given to less than 5% of accepted abstracts for high-quality, novel, and interesting research.
The poster presentation details are:
- Poster Number: P4275
- Session Date: October 29, 2024, 10:30 AM – 4:00 PM ET
- Presenting Author: Brian Feagan, MD, FRCPC
The research is embargoed until October 27, 2024, at 12:00 ET. Biora will make the poster available on their website at the time of presentation.
Biora Therapeutics (Nasdaq: BIOR) has achieved ISO 13485:2016 certification, demonstrating its commitment to global regulatory and quality standards. The certification, awarded by TÜV SÜD America, verifies Biora's robust quality management system for design, development, manufacturing, and distribution of its products.
CEO Adi Mohanty emphasized the significance of this achievement in meeting regulatory requirements as the company progresses with its NaviCap™ and BioJet™ platforms. ISO 13485 is an internationally recognized standard for medical device quality management systems, building upon ISO 9001 with additional regulatory requirements.
This certification aligns with the FDA's 2024 Quality Management System Regulation Final Rule, which harmonizes U.S. requirements with global standards through the adoption of ISO 13485 for medical devices.
