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.
Overview of Biora Therapeutics, Inc.
Biora Therapeutics, Inc. (Nasdaq: BIOR) is a clinical-stage biotechnology company that is revolutionizing therapeutic delivery through its innovative smart pill-based platforms. The company focuses on addressing critical unmet medical needs by enabling targeted and systemic delivery of therapeutics for chronic and complex diseases. Biora's two flagship platforms, the NaviCap™ and BioJet™, are designed to improve patient outcomes by offering precision delivery of drugs to the gastrointestinal (GI) tract and needle-free systemic delivery of large molecules, respectively.
Core Platforms and Technology
The NaviCap™ Targeted Oral Delivery Platform is engineered to treat inflammatory bowel disease (IBD), including conditions such as ulcerative colitis, by delivering therapeutic agents directly to the site of disease in the colon. Utilizing proprietary GItrac™ autolocation technology, the NaviCap device autonomously identifies targeted locations in the GI tract and releases a therapeutic payload. This approach increases drug concentration in affected tissues while minimizing systemic exposure, potentially improving efficacy and reducing side effects.
The BioJet™ Systemic Oral Delivery Platform is designed to replace traditional injections with an ingestible capsule that delivers liquid formulations of large molecules—such as peptides, proteins, and nucleic acids—directly into the small intestine. The device uses liquid jet injection technology to achieve systemic bioavailability comparable to subcutaneous injections. This needle-free delivery method simplifies drug administration and enhances patient adherence, particularly for chronic disease management.
Clinical Progress and Innovation
Biora has demonstrated significant progress in clinical development. The NaviCap platform has completed a Phase 1 trial for its BT-600 program, a drug-device combination for ulcerative colitis, showing successful targeted delivery to the colon with reduced systemic drug exposure. Similarly, the BioJet platform has shown promising preclinical results, achieving high oral bioavailability for various macromolecules in animal models. These advancements highlight the company's commitment to innovation and its potential to transform therapeutic delivery.
Market Position and Competitive Edge
Biora operates at the intersection of biotechnology and advanced drug delivery systems, targeting a rapidly growing market for precision medicine and chronic disease management. The company's competitive edge lies in its ability to address limitations of current treatments, such as the need for injections or systemic drug exposure. With an extensive patent portfolio comprising over 70 patent families, Biora secures its technological innovations and positions itself as a leader in the smart pill drug delivery space.
Challenges and Strategic Focus
As a clinical-stage company, Biora faces challenges such as regulatory approvals, financial sustainability, and competition from established pharmaceutical players. However, its strategic focus on partnerships and licensing agreements with large pharma companies positions it for long-term success. The company is actively engaged in collaborations to accelerate development and commercialization of its platforms.
Commitment to Patients and Future Outlook
Biora Therapeutics is dedicated to improving patient lives by reimagining how drugs are delivered. Through its innovative platforms, the company aims to enhance treatment outcomes, reduce patient burden, and expand therapeutic possibilities. With ongoing clinical trials and a robust pipeline, Biora is poised to make a significant impact in the fields of gastroenterology and chronic disease management.
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.
Biora Therapeutics (Nasdaq: BIOR) has been granted an extension by Nasdaq to regain compliance with listing requirements. The company now has until November 7, 2024 to meet the $50 million market value of listed securities rule and $1 bid price requirements for continued listing on The Nasdaq Global Market. CEO Adi Mohanty expressed optimism about upcoming company catalysts that could drive significant shareholder value. Biora is focused on developing innovative NaviCap™ and BioJet™ therapeutics platforms, which are part of their efforts to reimagine therapeutic delivery.
FAQ
What is the current stock price of BIORA THERAPEUTICS (BIOR)?
What is the market cap of BIORA THERAPEUTICS (BIOR)?
What is Biora Therapeutics' core focus?
What are the NaviCap™ and BioJet™ platforms?
How does Biora's technology improve drug delivery?
What clinical progress has Biora made?
What makes Biora Therapeutics unique in its industry?
What challenges does Biora Therapeutics face?
Who are Biora's target customers?
What is the significance of Biora's patent portfolio?
How does Biora plan to commercialize its platforms?
What is the long-term vision for Biora Therapeutics?
