Biora Therapeutics Updates and Reports Q1 2024 Financial Results

SAN DIEGO, May 15, 2024 – Biora Therapeutics, Inc. (Nasdaq: BIOR), a company dedicated to revolutionizing therapeutic delivery, has shared a corporate update and financial results for Q1 ending March 31, 2024. This period included significant advancements in their key platforms, NaviCap™ and BioJet™.

Chief Executive Officer Adi Mohanty expressed satisfaction with the interim results from the BT-600 clinical trial. The trial involved 24 healthy participants receiving doses of 5 mg and 10 mg tofacitinib or placebo over seven days. The results, expected in late June, indicate that the NaviCap™ platform potentially enhances JAK inhibitor therapy for ulcerative colitis by improving efficacy and reducing toxicity.

Biora's BioJet platform has also seen progress. Recent animal studies demonstrated better bioavailability and consistency for drug candidates, including semaglutide and adalimumab. The company is in the process of partnering with interested parties to further develop the BioJet platform, aiming to confirm partnerships by mid-2024.

First Quarter 2024 Highlights

NaviCap™ Targeted Oral Delivery Platform and BT-600

- Completion of Dosing in Phase 1 Clinical Trial for BT-600: The single-ascending dose (SAD) portion of the trial concluded with all participants showing systemic drug absorption, indicating successful drug release in the colon. Tofacitinib appeared in fecal samples, affirming colon-targeted delivery. Plasma levels of tofacitinib were significantly lower than conventional oral doses, suggesting efficient colonic absorption. The trial showed dose-proportional pharmacokinetics, reinforcing the platform's potential.

BioJet™ Systemic Oral Delivery Platform Preclinical Development

- Recent Animal Studies: The BioJet platform showed advances in bioavailability and consistency, surpassing the 15% bioavailability target compared to intravenous administration. This progress includes performance improvements for semaglutide and adalimumab, along with other collaborator molecules.

Capital Markets

- Capital Structure Optimization: Biora secured a third note exchange, raising $19.8 million since December 2023 and reducing outstanding notes by over $80 million in the last three quarters. This showcases investor confidence in the company.
- Access to Capital Markets: In Q1, Biora raised $3 million from monetizing legacy assets, $2.9 million in equity proceeds, and $6 million from a registered direct placement in April, totaling $31 million in new capital over four months.

Anticipated Milestones

NaviCap™ Platform and BT-600

- Completion of Final SAD/MAD Data: Expected in Q2 2024, with topline data presentation by end of the second quarter.
- Presentation at Digestive Disease Week (DDW): Clinical data on NaviCap device function across four studies, scheduled for May 19, 2024.
- New Clinical Study: Planned initiation in active ulcerative colitis patients in the latter half of 2024.

BioJet™ Platform Development

- Upcoming Presentation: Data from recent animal studies will be shared at the Next Gen Peptide Formulation & Delivery Summit in June 2024.
- Partnership Goals: The company is on track to secure a pharma partnership for the BioJet platform by 2024.

Financial Results for Q1 2024

- Operating expenses for Q1 2024 were $16.1 million, including $1.5 million in non-cash stock-based compensation. This compares to $13.3 million in Q4 2023.
- Net loss for Q1 2024 was $4.2 million, with a net loss per share of $0.14, compared to a net loss of $15.4 million in Q4 2023.
- For the same period in 2023, operating expenses were slightly lower at $15.5 million, with a net loss of $17.4 million and a net loss per share of $1.59.

In summary, Biora Therapeutics is making notable progress in its mission to transform therapeutic delivery. The company's ongoing clinical trials, platform developments, and strategic capital management are all contributing to a promising outlook for 2024.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!