BIOR

Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that is reimagining therapeutics, today shared a poster presented at the Parenteral Drug Association (PDA) Universe of Pre-Filled Syringes and Injection Devices Conference. The meeting in Palm Springs, California, October 18-19, 2022 explored the latest technological advances with drug delivery devices.

“Our platform is the first designed to use submucosal liquid jet injection to the small intestine for oral delivery of large molecules,” said Sharat Singh, PhD, Head of Research at Biora Therapeutics. “One challenge with a completely novel delivery method is there are no existing models to follow for preclinical development. We are encouraged by the data from the early results for these preclinical models, which informs the ongoing development of our systemic therapeutics platform,” continued Dr. Singh. 

The company presented a poster titled “Development of a submucosal injection device for an oral biotherapeutic delivery system,” presenting previous preclinical studies in which researchers determined animal models to use for evaluation of device performance and pharmacokinetics. They then evaluated device performance in a canine model using oral administration of the OBDS device and assessed pharmacokinetics in a swine model using endoscopic administration of the device.

The company successfully demonstrated ≥83% deployment accuracy in the canine small intestine, showing consistent deployment time post gastric emptying without early deployment in the stomach. Functionality of the endoscopic delivery method in swine was also demonstrated, with all devices successfully released in the small intestine to transit naturally and autonomously deploy in the small intestine. Eight animals showed detectable drug levels of a variant of adalimumab with an oral bioavailability average of 25% (range from 7-55%), excluding one animal with a late deployment at 72 hours post-dose. 

The poster can be viewed by visiting bioratherapeutics.com/publications. 

About Biora Therapeutics’ Systemic Therapeutics PlatformBiora Therapeutics’ systemic therapeutics platform uses an ingestible smart capsule for needle-free, oral delivery of biotherapeutics, with the potential to deliver a broad range of large molecules including monoclonal antibodies, peptides, and nucleic acids. Biora’s Oral Biotherapeutics Delivery System (OBDS) is an ingestible capsule designed to use proprietary liquid jet delivery to increase systemic uptake and bioavailability of large molecules. Once swallowed, the capsule is designed to transit through the digestive system and trigger in the small intestine, where liquid jets deliver drug directly into the intestinal tissue. The capsule is approximately the size of a multivitamin and can deliver up to 400µL of liquid formulation, such as proteins, peptides, and nucleic acids.

Biora is developing the PGN-OB2 program, which consists of a GLP-1 receptor agonist delivered via liquid jet into the small intestinal tissue using the OBDS capsule, for the treatment of type 2 diabetes. Oral GLP-1 receptor agonists are preferred by patients, and research indicates that people who start treatment with an injectable GLP-1 receptor agonist have a 71% higher discontinuation rate than those starting oral therapy. The company is currently advancing development of PGN-OB2 with preclinical studies.

About Biora TherapeuticsBiora Therapeutics is the biotech company that is reimagining therapeutics. By creating innovative smart pills designed for targeted drug delivery to the GI tract, and systemic, needle-free delivery of biotherapeutics, the company is developing therapies to improve patients’ lives. Biora envisions a world where patients have access to needle-free drug delivery and better therapeutic outcomes.

For more information, visit bioratherapeutics.com or follow the company on LinkedIn or Twitter.

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 efforts, are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “plan” 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 precision medicine, risks related to the supply and manufacturing of and complexity of components in our devices, 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 future revenue generating opportunities with current or future pharmaceutical collaborators, our ability to raise sufficient capital to achieve our business objectives, the ongoing COVID-19 pandemic, competition from other companies, 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, 2021 filed with the SEC and other subsequent documents, including Quarterly Reports, 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 Contactmedia@bioratherapeutics.com