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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 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.
Biora Therapeutics (Nasdaq: BIOR), a biotech company focused on reimagining therapeutic delivery, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. The event is scheduled for September 9-11, 2024, in New York, NY.
Key details of Biora's involvement include:
- A company presentation on Wednesday, September 11, 2024, at 2:00 PM Eastern time
- One-on-one investor meetings
- A live webcast of the presentation available at a provided link
A replay of the presentation will be accessible on Biora's website after the conference concludes. This participation offers Biora an opportunity to showcase its innovations and engage with potential investors in the biotech sector.
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