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Biora Therapeutics Licenses Preeclampsia Rule-Out Test for Commercial Development

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Biora Therapeutics has entered a licensing agreement with Avero Diagnostics to commercialize the Preecludia rule-out test for preeclampsia. This test aims to provide healthcare providers with a novel screening tool to assess preeclampsia risk based on multi-analyte protein biomarkers. Biora will receive commercial milestone payments and low double-digit royalties on net sales. The partnership is positioned to address unmet needs in prenatal care, with expectations of future revenue generation for Biora.

Positive
  • Licensing agreement with Avero Diagnostics for Preecludia test which could enhance market presence.
  • Potential for future revenue through milestone payments and low double-digit royalties.
  • Preecludia test addresses a significant unmet need for preeclampsia screening.
Negative
  • Dependence on Avero's success in commercializing the Preecludia test for future revenue.
  • Risks associated with regulatory approvals for the Preecludia test.

Avero Diagnostics to Develop and Commercialize, Enabling Potential Future Revenue for Biora Therapeutics

SAN DIEGO, Nov. 29, 2022 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that is reimagining therapeutic delivery, today announced it has completed an agreement to license its Preecludia™ rule-out test for preeclampsia to Avero Diagnostics, formerly Northwest Pathology, for commercial development.

“We have been impressed with the Avero team’s execution on several diagnostic assets, and we are excited to again partner with them to commercialize this assay, which we believe will offer providers a new screening aid in an area of great unmet need,” said Adi Mohanty, Chief Executive Officer of Biora Therapeutics. “As we have shown, we remain committed to value creation from all our assets while Biora focuses on the progress of its therapeutics pipeline.”

“We are excited to leverage the work done by Biora and fully validate and commercialize this innovative test, which will serve a valuable purpose in the prenatal care community,” said Ryan Fortna, M.D., Ph.D., president of Avero Diagnostics. “This fits well in our product offerings for our existing OB/GYN-focused client base, and presents a large opportunity as a differentiating factor for future growth.”

Under the terms of the agreement, Avero Diagnostics receives rights to assets and intellectual property related to the Preecludia test. Biora will receive commercial milestone payments and low double-digit royalties on net sales.

About the Preecludia™ Test
The Preecludia rule-out test for preeclampsia has the potential to be the first-of-its-kind test in the United States to help healthcare providers evaluate patients who have signs and symptoms of possible preeclampsia. This laboratory developed test (LDT) is a novel, multi-analyte protein biomarker assay designed to examine markers from multiple pathophysiological pathways of preeclampsia to assess risk. It is designed to be run from a simple blood draw and is intended to address the unmet need for tools to aid in the assessment and management of preeclampsia. The company previously shared topline results from the clinical validation study for the Preecludia test, which was followed by publication of the validation study in Hypertension, a journal of the American Heart Association.

About Biora Therapeutics
Biora Therapeutics is the biotech company that is reimagining therapeutic delivery. 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 Statements
This 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 potential future payments related to the Preecludia license transaction with Avero Diagnostics, 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, Avero’s ability to successfully commercialize the Preecludia test, and as a result, our ability to collect any future milestone or royalty payments, 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 Contact
Chuck Padala
Managing Director, LifeSci Advisors
IR@bioratherapeutics.com
(646) 627-8390

Media Contact
media@bioratherapeutics.com


FAQ

What is the recent licensing agreement involving Biora Therapeutics (BIOR)?

Biora Therapeutics has licensed its Preecludia test to Avero Diagnostics for commercial development, aiming to enhance its revenue potential.

What are the financial terms of the agreement between Biora Therapeutics and Avero Diagnostics?

Biora will receive commercial milestone payments and low double-digit royalties on net sales from the Preecludia test.

What is the Preecludia test developed by Biora Therapeutics?

The Preecludia test is designed to evaluate preeclampsia risk using a multi-analyte protein biomarker assay from a simple blood draw.

What is the significance of the Preecludia test for healthcare providers?

Preecludia provides a new screening aid in prenatal care, addressing a significant unmet need for assessing preeclampsia.

What risks does Biora Therapeutics face regarding the Preecludia test commercialization?

Biora faces risks related to Avero's ability to successfully commercialize the test and obtain necessary regulatory approvals.

Biora Therapeutics, Inc.

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