SAN DIEGO - Biora Therapeutics, Inc. (NASDAQ:BIOR), a clinical-stage biotech company, announced today significant progress in the development of its BioJet™ Oral Delivery Platform. The platform aims to replace traditional injections with a needle-free, oral delivery method. The update was shared at the 14th Annual Partnership in Drug Delivery meeting in Boston, Massachusetts.
The company has successfully demonstrated the ability of its smaller, 00-size BioJet device to autonomously deliver medication to the small intestine in canine models. According to Biora's CEO, Adi Mohanty, this advancement is in line with the preferences of patients and pharmaceutical companies. Biora has commenced further development in advanced animal models in collaboration with mega-cap pharma partners, with the objective of maximizing licensing opportunities across various verticals.
The BioJet platform has undergone over 30 in vivo studies, showcasing oral bioavailability rates exceeding 30% compared to intravenous administration for certain molecules, including peptides and antibodies. This translates to an oral bioavailability rate of 60-80% compared to subcutaneous injections. The BioJet device, a swallowable autoinjector, uses liquid jet injection to administer drug formulations into the small intestine's submucosa. Notably, the device can deliver over 300 microliters, with a capacity for doses larger than 50 milligrams, making it the most significant payload for an ingestible injectable to date.
Biora anticipates completing full functional testing of the BioJet device by the end of Q4 2024 and molecule-specific feasibility testing by Q1 2025. The company's broader portfolio includes the NaviCap™ platform, targeting the treatment of IBD through localized delivery in the gastrointestinal tract.
The forward-looking statements in the press release carry inherent risks and uncertainties, and actual results could differ materially from those projected. These statements are based on the company's plans, estimates, and expectations as of today. Biora Therapeutics cautions that any obligation to update forward-looking statements is expressly disclaimed, except as required by law. The information in this article is based on a press release statement from Biora Therapeutics, Inc.
In other recent news, Biora Therapeutics has announced significant changes to its capital structure, including a 10-for-1 reverse stock split and a reduction in authorized shares. The company has also secured additional funding, bringing the total recent funding to $8 million, and has entered into several transactions aimed at restructuring its debt and providing capital for ongoing operations.
Biora Therapeutics has reported advancements in its BT-600 program and BioJet platform, with second-quarter 2024 earnings surpassing negative estimates, resulting in earnings per share (EPS) of $0.18. The investment firm H.C. Wainwright has reiterated a Buy rating for Biora Therapeutics, anticipating increased business development and collaboration announcements over the next year.
These are among the recent developments for Biora Therapeutics, which has also secured an additional $4 million in financing as part of an initiative to raise up to $16 million in capital. The company has also entered into a series of transactions, including a Convertible Notes Purchase Agreement, a Convertible Notes Exchange Agreement, and issuing additional warrants.
Biora Therapeutics has finalized a Convertible Notes Purchase Agreement, selling $16 million in aggregate principal amount of its 11.00%/13.00% Convertible Senior Secured Notes due 2028. The company has also entered into a Convertible Notes Exchange Agreement, exchanging approximately $10.76 million in principal amount of existing 2028 Notes for a new series of Payment Priority Notes.
Finally, Biora Therapeutics has reported successful Phase I clinical trial results for its BT-600 program, utilizing the NaviCap platform for targeted drug delivery to the colon. The company is preparing to present data from the BT-600 clinical trial at the American College of Gastroenterology meeting in October.
InvestingPro Insights
As Biora Therapeutics (NASDAQ:BIOR) advances its innovative BioJet™ Oral Delivery Platform, investors should consider some key financial metrics and insights from InvestingPro.
Despite the promising developments in Biora's drug delivery technology, the company faces significant financial challenges. InvestingPro data shows that Biora's market capitalization stands at a modest $14.34 million, reflecting the early-stage nature of its operations. The company's revenue for the last twelve months as of Q2 2024 was just $0.86 million, highlighting the pre-commercial stage of its products.
An InvestingPro Tip indicates that Biora is "quickly burning through cash," which is not uncommon for biotech companies in the research and development phase. This aligns with the company's focus on advancing its BioJet and NaviCap platforms towards commercialization. Another relevant InvestingPro Tip notes that "analysts anticipate sales growth in the current year," which could be tied to the potential licensing opportunities Biora is pursuing with pharmaceutical partners.
It's worth noting that InvestingPro offers 14 additional tips for Biora Therapeutics, providing a more comprehensive analysis for investors interested in this biotech stock.
The company's financial position appears precarious, with InvestingPro data showing a significant operating loss of $67.97 million in the last twelve months. This underscores the importance of Biora's strategic partnerships and the potential success of its drug delivery platforms for future financial stability.
As Biora Therapeutics progresses towards its milestones in Q4 2024 and Q1 2025, investors should closely monitor the company's cash burn rate and any updates on partnership agreements that could provide much-needed capital for continued development.
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