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BIORA THERAPEUTICS INC - BIOR STOCK NEWS

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Overview of Biora Therapeutics, Inc.

Biora Therapeutics, Inc. (Nasdaq: BIOR) is a clinical-stage biotechnology company that is revolutionizing therapeutic delivery through its innovative smart pill-based platforms. The company focuses on addressing critical unmet medical needs by enabling targeted and systemic delivery of therapeutics for chronic and complex diseases. Biora's two flagship platforms, the NaviCap™ and BioJet™, are designed to improve patient outcomes by offering precision delivery of drugs to the gastrointestinal (GI) tract and needle-free systemic delivery of large molecules, respectively.

Core Platforms and Technology

The NaviCap™ Targeted Oral Delivery Platform is engineered to treat inflammatory bowel disease (IBD), including conditions such as ulcerative colitis, by delivering therapeutic agents directly to the site of disease in the colon. Utilizing proprietary GItrac™ autolocation technology, the NaviCap device autonomously identifies targeted locations in the GI tract and releases a therapeutic payload. This approach increases drug concentration in affected tissues while minimizing systemic exposure, potentially improving efficacy and reducing side effects.

The BioJet™ Systemic Oral Delivery Platform is designed to replace traditional injections with an ingestible capsule that delivers liquid formulations of large molecules—such as peptides, proteins, and nucleic acids—directly into the small intestine. The device uses liquid jet injection technology to achieve systemic bioavailability comparable to subcutaneous injections. This needle-free delivery method simplifies drug administration and enhances patient adherence, particularly for chronic disease management.

Clinical Progress and Innovation

Biora has demonstrated significant progress in clinical development. The NaviCap platform has completed a Phase 1 trial for its BT-600 program, a drug-device combination for ulcerative colitis, showing successful targeted delivery to the colon with reduced systemic drug exposure. Similarly, the BioJet platform has shown promising preclinical results, achieving high oral bioavailability for various macromolecules in animal models. These advancements highlight the company's commitment to innovation and its potential to transform therapeutic delivery.

Market Position and Competitive Edge

Biora operates at the intersection of biotechnology and advanced drug delivery systems, targeting a rapidly growing market for precision medicine and chronic disease management. The company's competitive edge lies in its ability to address limitations of current treatments, such as the need for injections or systemic drug exposure. With an extensive patent portfolio comprising over 70 patent families, Biora secures its technological innovations and positions itself as a leader in the smart pill drug delivery space.

Challenges and Strategic Focus

As a clinical-stage company, Biora faces challenges such as regulatory approvals, financial sustainability, and competition from established pharmaceutical players. However, its strategic focus on partnerships and licensing agreements with large pharma companies positions it for long-term success. The company is actively engaged in collaborations to accelerate development and commercialization of its platforms.

Commitment to Patients and Future Outlook

Biora Therapeutics is dedicated to improving patient lives by reimagining how drugs are delivered. Through its innovative platforms, the company aims to enhance treatment outcomes, reduce patient burden, and expand therapeutic possibilities. With ongoing clinical trials and a robust pipeline, Biora is poised to make a significant impact in the fields of gastroenterology and chronic disease management.

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Biora Therapeutics, Inc. secures $3 million in nondilutive capital through the monetization of legacy assets and $2.8 million in new capital from a convertible notes exchange with Context Capital. The company has significantly reduced its debt by over $80 million and attracted $19.8 million in new capital from institutional investors. Biora continues to optimize its capital structure and advance its therapeutic programs, with upcoming data release from the SAD portion of its phase 1 clinical trial.
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Biora Therapeutics, Inc. completes SAD cohorts for BT-600 clinical study, with MAD dosing to start in March. The drug-device combination aims to treat ulcerative colitis by delivering tofacitinib directly to the colon for improved efficacy and reduced adverse events. Data from the SAD portion to be shared in March corporate update.
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Biora Therapeutics, Inc. (Nasdaq: BIOR) will participate in the Inflammatory Bowel Disease Symposium hosted virtually by Canaccord Genuity Capital Markets on February 28, 2024. Ariella Kelman, M.D., Chief Medical Officer, will participate in the panel titled 'The Next Evolutionary Steps in Addressing IBD.'
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Biora Therapeutics, Inc. (Nasdaq: BIOR) will participate in a virtual fireside chat hosted by H.C. Wainwright & Co. to discuss the company’s delivery platforms addressing significant therapeutics indications, including its first ongoing clinical trial. The event is scheduled for January 29, 2024, at 11:00 AM Eastern / 8:00 AM Pacific. Adi Mohanty, CEO, Ariella Kelman, M.D., CMO, and Eric d’Esparbes, CFO, will be the speakers. A live webcast and replay of the fireside chat session will be available through the Investor Relations section of the Biora website.
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Biora Therapeutics, Inc. (Nasdaq: BIOR) provided guidance on anticipated milestones in 2024, including clinical study results for NaviCap™ Targeted Oral Delivery Platform and progress on pharma partnerships for BioJet™ Systemic Oral Delivery Platform. The company completed a transformation in 2023, laying the foundation for significant value inflection. The phase 1 study for BT-600, a de-risking step in NaviCap™ platform development, is underway. The company expects to progress relationships with large pharma companies for the BioJet platform, potentially providing non-dilutive funding for further development.
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Biora Therapeutics, a biotech company listed on Nasdaq as BIOR, announced the initiation of its phase 1, first-in-human clinical study of BT-600, a drug-device combination program designed to deliver a unique, liquid formulation of tofacitinib to the colon for the potential treatment of moderate to severe ulcerative colitis. The study aims to evaluate the safety, pharmacokinetics, and pharmacodynamics of BT-600 in healthy adult volunteers, with expectations of increased colonic tissue drug levels and reduced systemic levels compared with conventional oral tofacitinib.
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Biora Therapeutics, Inc. (Nasdaq: BIOR) announced that its BioJet™ Systemic Oral Delivery Platform has exceeded performance targets in a preclinical study conducted in collaboration with AstraZeneca. The study demonstrated greater than 25% bioavailability compared to subcutaneous delivery, showcasing the platform's potential to deliver multi-milligram liquid doses similar to injection with minimal to no formulation changes. The company continues to generate promising results, enabling further development under the collaboration.
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Biora Therapeutics, Inc. (Nasdaq: BIOR) announces receipt of US Patent No. 11,857,669 for targeted delivery of JAK inhibitors to the gastrointestinal tract, a significant win for its BT-600 program and NaviCap™ targeted oral delivery platform.
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Biora Therapeutics, Inc. (Nasdaq: BIOR) announced an agreement with institutional investors to reduce the company’s net debt by 60% through a convertible note exchange, bringing $16.7 million in new capital. The company has reduced its debt by $83 million in 2023, achieving a 75% overall reduction. The transaction demonstrates investor confidence in the company's innovative technologies and near-term catalysts for its NaviCap™ and BioJet™ platforms.
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Biora Therapeutics, Inc. (Nasdaq: BIOR) announced a new research collaboration with a large pharmaceutical company to test the BioJet Systemic Oral Delivery Platform in animal models. The agreement provides funding to test the platform’s ability to achieve bioavailability through oral delivery of the collaborator’s molecules to the small intestine. The CEO, Adi Mohanty, highlighted the progress and recognition by others, stating that they are actively conducting studies with multiple collaborators and looking forward to performing studies with the big pharma collaborator in the first quarter. Biora's BioJet technology features strong patent protection and promises category-leading oral bioavailability for large molecules.
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FAQ

What is the current stock price of BIORA THERAPEUTICS (BIOR)?

The current stock price of BIORA THERAPEUTICS (BIOR) is $0.22 as of February 7, 2025.

What is the market cap of BIORA THERAPEUTICS (BIOR)?

The market cap of BIORA THERAPEUTICS (BIOR) is approximately 995.0K.

What is Biora Therapeutics' core focus?

Biora Therapeutics focuses on developing smart pill-based platforms for targeted and systemic drug delivery to improve patient outcomes in chronic and complex diseases.

What are the NaviCap™ and BioJet™ platforms?

The NaviCap™ platform targets drug delivery to the colon for treating IBD, while the BioJet™ platform enables needle-free, oral delivery of large molecules for systemic therapies.

How does Biora's technology improve drug delivery?

Biora's platforms use advanced technologies like autolocation and liquid jet injection to deliver drugs precisely to the GI tract or systemically, enhancing efficacy and reducing side effects.

What clinical progress has Biora made?

Biora's NaviCap platform has completed a Phase 1 trial for ulcerative colitis, demonstrating targeted delivery to the colon. The BioJet platform has shown high oral bioavailability in preclinical studies.

What makes Biora Therapeutics unique in its industry?

Biora's innovative smart pill platforms address unmet medical needs by replacing injections with oral delivery and enabling localized treatment, supported by an extensive patent portfolio.

What challenges does Biora Therapeutics face?

As a clinical-stage company, Biora faces challenges such as regulatory approvals, financial constraints, and competition from traditional drug delivery methods.

Who are Biora's target customers?

Biora's platforms target pharmaceutical companies seeking advanced drug delivery solutions and patients requiring improved therapies for chronic diseases like IBD.

What is the significance of Biora's patent portfolio?

Biora holds over 70 patent families, securing its innovations in smart pill technology and establishing its leadership in the drug delivery industry.

How does Biora plan to commercialize its platforms?

Biora is pursuing partnerships and licensing agreements with large pharmaceutical companies to accelerate development and commercialization of its platforms.

What is the long-term vision for Biora Therapeutics?

Biora aims to transform therapeutic delivery by advancing its smart pill platforms, improving patient outcomes, and expanding treatment possibilities for chronic diseases.
BIORA THERAPEUTICS INC

Nasdaq:BIOR

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994.99k
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6.42%
Biotechnology
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