Biora Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing innovative drug delivery platforms to improve patient outcomes. The company's two key therapeutic delivery platforms, NaviCap™ and BioJet™, aim to address the limitations of current treatment approaches in inflammatory bowel disease (IBD) and chronic diseases, respectively.
Financials
In the company's most recent fiscal year, Biora reported annual revenue of $4 million and a net loss of $124.1 million. The company's annual operating cash flow was negative $48.5 million, while its annual free cash flow stood at negative $48.6 million. These financial results reflect Biora's continued investment in research and development to advance its pipeline of novel drug delivery technologies.
In the first quarter of 2024, Biora reported a net loss of $4.2 million, which included non-cash stock-based compensation expense and a gain from changes in warrant liabilities. The company's operating expenses, excluding stock-based compensation, were $40.5 million, with the majority of the spend allocated to research and development activities, including the execution of the company's clinical development with NaviCap and preclinical work on the BioJet platform.
Business Overview
NaviCap Platform
Biora's NaviCap platform is designed to improve outcomes for patients with IBD, such as ulcerative colitis, by enabling targeted delivery of therapeutics directly to the site of disease in the gastrointestinal tract. The company's lead NaviCap program, BT-600, is a drug-device combination product that utilizes the NaviCap ingestible device to deliver a proprietary liquid formulation of tofacitinib to the colon.
BioJet Platform
Biora's BioJet platform is designed to replace injection with needle-free, oral delivery of large molecules for better management of chronic diseases. The company has completed additional animal studies over the past few months that demonstrate advances in consistency and bioavailability for its peptide and antibody candidates, as well as for molecules from its collaborators.
Recent Developments
The company is currently running a partnering process for the BioJet platform, with the goal of having a critical mass of data and interested parties to have partner stated interest confirmed by mid-year. Biora is evaluating like-minded partners who see the potential for the BioJet platform and are eager to bring this technology to the clinic.
Biora's clinical development efforts have been focused on its NaviCap platform, with the company recently completing the multiple ascending dose (MAD) portion of its Phase 1 clinical trial for BT-600. The company plans to share data from the completed single-ascending dose (SAD) and MAD study towards the end of the second quarter of 2024. Additionally, Biora will present clinical data on the function of the NaviCap device across four different studies in healthy human participants and active use in patients at the Digestive Disease Week Conference later this month.
Outlook
Looking ahead, Biora anticipates initiating a clinical study with BT-600 in patients with ulcerative colitis during the second half of 2024. The company will also provide an update on data from recent animal studies for the BioJet platform at the Next-Gen Peptide Formulation and Delivery Summit in June 2024.
Liquidity
Biora's financial position has seen significant improvements in recent quarters, with the company reducing its outstanding convertible notes by more than $80 million in 2023, a 75% reduction in net debt. During the first quarter of 2024, Biora further progressed its capital structure optimization by completing a third note exchange combined with new capital investments, bringing the total new institutional investment into the company through these exchanges to $19.8 million in the last two quarters. Additionally, the company secured $3 million from the monetization of legacy assets, $2.9 million in equity proceeds, and $6 million through a registered direct placement, which closed in early April 2024.
The company's liquidity position has been bolstered by these capital market activities, setting the stage for the upcoming clinical data readout and the development of partnerships for the BioJet platform. Biora's management team remains focused on executing its strategic priorities and delivering on its mission to reimagine therapeutic delivery and improve patient outcomes.
Conclusion
Biora Therapeutics is a clinical-stage biotechnology company with a compelling pipeline of innovative drug delivery platforms. The company's NaviCap and BioJet platforms hold the potential to address significant unmet needs in inflammatory bowel disease and chronic disease management, respectively. As Biora continues to advance its clinical programs and pursue strategic partnerships, investors will closely monitor the company's progress and the potential impact of its novel delivery technologies on the treatment landscape.