Biora Therapeutics Shares Progress on Smaller BioJet™ Clinical Device with Largest Payload of any Ingestible Injectable at the 14th Annual PODD Meeting

BIOR 10.28.2024

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Expanded collaborations to support rapid testing in advanced animal models in Q4 2024

SAN DIEGO, Oct. 28, 2024 (GLOBE NEWSWIRE) --Biora Therapeutics, Inc.(Nasdaq: BIOR), the biotech company reimagining therapeutic delivery, today is sharing progress on its development of the BioJetTM Oral Delivery Platform, which is designed to replace injection with needle-free, oral delivery, at the 14thAnnual Partnership in Drug Delivery (PODD) meeting in Boston, Massachusetts.

“We have now demonstrated the ability to autonomously deliver to the small intestine in canine models with our smaller, 00-size BioJet device, a size that is desired by both patients and pharma companies,” said Adi Mohanty, Chief Executive Officer of Biora Therapeutics. “We have agreed with existing mega-cap pharma collaborators to rapidly progress development in advanced animal models. The goal of this approach is to maximize licensing potential by enabling agreements within multiple verticals using a form factor desired by all our collaborators. We believe this is preferable to an exclusive development path based on the larger, 000-size device. We anticipate completing full functional testing in Q4 2024 and molecule-specific feasibility testing during Q1 2025.”

BioJet delivery technology has been proven in over 30in vivostudies with both internal and collaborator molecules. The BioJet platform has achieved oral bioavailability greater than 30% vs. intravenous administration for molecules including peptides, antibodies, and antisense oligonucleotides, which equates to 60–80% oral bioavailability compared to subcutaneous injection.

The BioJet delivery device is a swallowable, needle-free autoinjector that uses liquid jet injection to deliver existing liquid drug formulations into the submucosa of the small intestine. With the ability to deliver doses greater than 50 milligrams, BioJet offers the largest drug payload among ingestible injectables. Its size has been successfully decreased from capsule size 000 to size 00, while increasing payload capacity to over 300 microliters.

About the BioJetTM Oral Delivery PlatformBiora’sBioJet platformfor oral delivery of macromolecules is designed to replace injection with needle-free, oral delivery. The BioJet device is a swallowable autoinjector thatuses liquid jet injection to deliver drug into the submucosa of the small intestine.

The BioJet platform is designed to provide category-leading oral bioavailability for a wide range of molecules, including proteins, peptides, and nucleic acids. The 00-size BioJet device delivers standard liquid drug formulations with a capacity of >300 microliters. It offers the largest drug payload of any ingestible injectable, with the ability to deliver doses greater than 50 milligrams.

About Biora TherapeuticsBiora Therapeutics is a clinical-stage biotech company developing two smart pill-based therapeutics platforms: theNaviCapTM platform for colon-targeted treatment of IBD, designed to improve patient outcomes through treatment at the site of disease in the gastrointestinal tract, and theBioJetTM platform for oral delivery of large molecules, designed to replace injection with needle-free, oral delivery.

For more information, visitbioratherapeutics.comor follow the company onLinkedInorX.

Safe Harbor Statement or Forward-Looking StatementsThis press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, including statements concerning the progress and future expectations and goals of our research and development, preclinical and clinical trial activities, and partnering and collaboration efforts with third parties, are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “envision,” “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “anticipate,” “forward,” “believe,” “design,” “estimate,” “predict,” “projects,” “projecting,” “potential,” “plan,” “goal(s),” “target,” or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements reflect our plans, estimates, and expectations, as of the date of this press release. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this press release. Such risks, uncertainties, and other factors include, among others, our ability to innovate in the field of therapeutics, our ability to make future FDA filings and initiate and execute clinical trials on expected timelines or at all, our ability to obtain and maintain regulatory approval or clearance of our products on expected timelines or at all, our plans to research, develop, and commercialize new products, the unpredictable relationship between preclinical study results and clinical study results, our expectations regarding allowed patents or intended grants to result in issued or granted patents, our expectations regarding opportunities with current or future pharmaceutical collaborators or partners, our ability to raise sufficient capital to achieve our business objectives, our ability to maintain our listing on the Nasdaq Global Market, and those risks described in “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the year ended December 31, 2023 filed with the Securities and Exchange Commission (SEC) and other subsequent documents, including Quarterly Reports on Form 10-Q, that we file with the SEC.

Biora Therapeutics expressly disclaims any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.

Investor ContactChuck PadalaManaging Director, LifeSci AdvisorsIR@bioratherapeutics.com(646) 627-8390

Media ContactLiz RobinsonCG Lifelrobinson@cglife.com

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