Biora Therapeutics, Inc.

SAN DIEGO, Oct. 29, 2024 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company reimagining therapeutic delivery, today announced that it has entered into definitive agreements for the purchase and sale of 745,342 shares of the Company’s common stock at an offering price of $4.025 per share of common stock in a registered direct offering priced at-the-market under Nasdaq rules. In addition, in a concurrent private placement, the Company will issue unregistered warrants to purchase up to 745,342 shares of common stock. The warrants have an exercise price of $3.90 per share, will be exercisable upon issuance, and will expire five years following issuance. The closing of the offering is expected to occur on or about October 29, 2024, subject to the satisfaction of customary closing conditions. H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering. The gross proceeds to Biora from this offering are expected to be approximately $3 million, before deducting the placement agent’s fees and other offering expenses. Biora intends to use the net proceeds from this offering to support its operations, make further investments in the development of its oral biotherapeutics platforms, and for working capital and general corporate purposes. The shares of common stock (but not the warrants issued in the private placement or the shares of common stock underlying the warrants) are being offered by the Company pursuant to a shelf registration statement on Form S-3 (File No. 333-279539) that was filed with the Securities and Exchange Commission (“SEC”) on May 20, 2024 and was declared effective on May 31, 2024. The offering of the shares of common stock is being made only by means of a prospectus, including a prospectus supplement, forming a part of an effective registration statement. A prospectus supplement and accompanying prospectus relating to the offering of the shares of common stock will be filed with the SEC. Electronic copies of the prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at http://www.sec.gov or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at placements@hcwco.com. The Company also has agreed to amend certain existing warrants to purchase up to an aggregate of 531,162 shares of the Company’s common stock that were previously issued to investors on dates ranging from November 2022 to April 2024, each with an exercise price of $11.00 per share, for $0.125 per amended warrant, effective upon the closing of the offering, such that the amended warrants will have a reduced exercise price of $3.90 per share and will expire five years from the date of closing of the offering. The warrants described above are being issued in a concurrent private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. About Biora TherapeuticsBiora Therapeutics is a clinical-stage biotech company developing two smart pill-based therapeutics platforms: the NaviCap™ platform for colon-targeted treatment of IBD, designed to improve patient outcomes through treatment at the site of disease in the gastrointestinal tract, and the BioJet™ platform for oral delivery of large molecules, designed to replace injection with needle-free, oral delivery. For more information, visit bioratherapeutics.com or follow the company on LinkedIn or X. Safe Harbor Statement or Forward-Looking StatementsThis press release contains “forward-looking statements” that involve a number of risks, uncertainties and assumptions. These forward-looking statements can generally be identified as such because the context of the statement will include words such as “may,” “will,” “intend,” “plan,” “believe,” “anticipate,” “expect,” “estimate,” “predict,” “potential,” “continue,” “likely,” “target,” “forecast,” or “opportunity,” the negative of these words or other similar words. Similarly, statements that describe our plans, strategies, intentions, expectations, objectives, goals or prospects and other statements that are not historical facts are also forward-looking statements. For such statements, we claim the protection of the Private Securities Litigation Reform Act of 1995. Readers of this press release are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. These forward-looking statements are based largely on our expectations and projections about future events and future trends affecting our business, and are subject to risks and uncertainties that could cause actual results to differ materially from those anticipated in the forward-looking statements, including statements regarding the consummation of the offering, the satisfaction of customary closing conditions related to the offering and the use of proceeds in the offering. Such risks, uncertainties, and other factors include, among others, risks and uncertainties related to market and other conditions that may affect the timing, terms or conditions of the offering, the Company’s ability to consummate the offering on the anticipated terms or at all, the Company’s ability to innovate in the field of therapeutics, the Company’s ability to make future filings and initiate, execute, or complete clinical trials on expected timelines or at all, the Company’s ability to obtain and maintain regulatory approval or clearance of its products on expected timelines or at all, the Company’s plans to research, develop, and commercialize new products, the unpredictable relationship between preclinical study results and clinical study results, the Company’s expectations regarding opportunities with current or future pharmaceutical collaborators or partners, the Company’s ability to raise sufficient capital to achieve its business objectives, the Company’s ability to maintain its 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 the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC and other subsequent documents, including Quarterly Reports, that the Company files 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

Expanded collaborations to support rapid testing in advanced animal models in Q4 2024SAN 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 BioJet™ Oral Delivery Platform, which is designed to replace injection with needle-free, oral delivery, at the 14th Annual 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 30 in vivo studies 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 BioJet™ Oral Delivery PlatformBiora’s BioJet platform for oral delivery of macromolecules is designed to replace injection with needle-free, oral delivery. The BioJet device is a swallowable autoinjector that uses 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: the NaviCap™ platform for colon-targeted treatment of IBD, designed to improve patient outcomes through treatment at the site of disease in the gastrointestinal tract, and the BioJet™ platform for oral delivery of large molecules, designed to replace injection with needle-free, oral delivery. For more information, visit bioratherapeutics.com or follow the company on LinkedIn or X. 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

SAN DIEGO, Oct. 14, 2024 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company reimagining therapeutic delivery, today announced that Adi Mohanty, CEO of Biora Therapeutics, will present on the company’s 00-size BioJet™ device at the 14th Annual Partnership Opportunities in Drug Delivery (PODD) meeting, taking place in Boston, October 28–29, 2024. “As part of the development of our clinical-ready BioJet device, we were able to reduce its size from 000 to 00, while slightly increasing the payload capacity,” said Adi Mohanty, Chief Executive Officer of Biora Therapeutics. “Market research indicates a strong patient preference for a 00-size device, a preference that is shared by our pharma collaborators. We are excited about the progress we’ve made with this revolutionary, needleless, liquid injection technology in a smaller capsule that is readily accepted by patients. In addition to providing updates on our BioJet and NaviCap platforms, the PODD meeting also provides an opportunity to meet with a number of our existing pharma collaborators as we are in the process of expanding those relationships.” Details of the presentation are as follows: Presentation Title:Solving Drug Delivery Challenges with Ingestible Drug-Device CombinationsDate & Time:October 28, 2024, 3:30 – 3:45 PM Eastern TimeTrack:3A: Oral, Mucosal, Transdermal & Other Non-Injectable TechnologiesLocation:Westin Boston Seaport, Grand Ballroom D/E, Concourse Level PODD brings together professionals from pharma, biotech, and drug delivery industries to assess delivery needs and share information on the latest advances in drug delivery technologies that can potentially improve the delivery of various types of drugs, including proteins, peptides, mRNA therapies, oncology therapeutics, and small molecules. About Biora TherapeuticsBiora Therapeutics is a clinical-stage biotech company developing two smart pill-based therapeutics platforms: the NaviCap™ platform for colon-targeted treatment of IBD, designed to improve patient outcomes through treatment at the site of disease in the gastrointestinal tract, and the BioJet™ platform for oral delivery of large molecules, designed to replace injection with needle-free delivery. For more information, visit bioratherapeutics.com or follow the company on LinkedIn or X. 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, including those involving BT-600 and our NaviCap platform and model-based data projections for the BT-600 program, 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