Biora Therapeutics, Inc. is a clinical-stage biotech company that is revolutionizing the way therapeutics are delivered. The company’s innovative platforms, NaviCap™ and BioJet™, aim to overcome the limitations of traditional drug delivery methods, offering patients and healthcare providers more effective and convenient treatment options.
Company History and Background
The company’s history traces back to 2010, when it was founded as Progenity, Inc. and focused on genetic carrier screening and non-invasive prenatal testing. However, in 2021, the company undertook a strategic transformation, divesting its legacy laboratory operations to concentrate solely on the development of its two transformative therapeutic delivery platforms. Biora Therapeutics commenced operations with its corporate office located in San Diego, California. Through its former affiliation with Mattison Pathology, LLP, Biora’s operations also included anatomic and molecular pathology testing products.
The company’s journey has not been without challenges. In 2018, Biora received civil investigative demands and subpoenas from government agencies regarding its legacy commercial practices. The company successfully resolved these matters in 2020 by entering into agreements with certain governmental agencies and participating states. As part of the resolution, Biora entered into a five-year Corporate Integrity Agreement with the Office of Inspector General of the Department of Health and Human Services.
Furthermore, Biora has faced post-payment review audits and other forms of reviews and investigations related to government reimbursement and commercial payor programs for its historical testing business. While the company believes it complied with applicable laws and regulations, it has had to negotiate and settle certain claims with third-party payors in the past regarding alleged overpayments. These reimbursement-related matters posed challenges for the company’s legacy operations.
Innovative Platforms
NaviCap™: Targeted Delivery to the Colon
Biora’s NaviCap™ platform is designed to deliver therapeutics directly to the site of disease in the gastrointestinal tract, with a specific focus on the treatment of inflammatory bowel diseases (IBDs) such as ulcerative colitis. The platform utilizes an ingestible, programmable device that is designed to release its payload at the entry point of the colon, allowing for targeted drug delivery.
In a recently completed Phase 1 clinical trial for the company’s lead NaviCap™ candidate, BT-600, the results were extremely promising. The trial demonstrated that the NaviCap™ device was able to achieve precise drug delivery to the entire colon, with significantly lower systemic exposure compared to conventional oral administration. Importantly, the data modeling suggested that the drug concentrations in the colon tissue exceeded the targeted therapeutic levels for an extended period, potentially improving efficacy while reducing safety risks.
These results support the advancement of BT-600 into a Phase Ib trial in ulcerative colitis patients, as the company seeks to break the therapeutic ceiling that has long plagued this debilitating condition. With the ability to optimize the delivery of existing drug therapies, such as JAK inhibitors, the NaviCap™ platform holds the potential to substantially improve outcomes for IBD patients.
BioJet™: Needle-Free Systemic Delivery
Biora’s second platform, BioJet™, is designed to replace the need for injections by enabling the oral delivery of large molecule therapeutics, such as peptides, proteins, and antibodies. This needle-free approach could significantly improve patient convenience and compliance, while potentially enhancing the pharmacokinetic profile of these complex molecules.
The BioJet™ platform has demonstrated impressive results, with the company reporting bioavailability levels of around 40% in preclinical studies – a remarkable achievement considering the industry has historically struggled to achieve even single-digit bioavailability for orally administered large molecules. This performance has garnered significant interest from major pharmaceutical companies, and Biora is currently engaged in active partnership discussions to further advance the BioJet™ technology.
Financials and Liquidity
Biora Therapeutics reported revenues of $4 million for the fiscal year 2023, a significant decrease from $892 million in the prior year. This decline was primarily due to the company’s strategic transformation in 2021, which involved the closure of its legacy genetics laboratory and the sale of its Avero diagnostics business. The net loss for 2023 was $124.115 million, with operating cash flow (OCF) of -$48.499 million and free cash flow (FCF) of -$48.602 million.
For the third quarter of 2024, Biora reported revenues of $32,000, with a net loss of $18.402 million. Notably, the company saw a significant improvement in cash flow, with OCF of $31.823 million and FCF of $31.951 million. This increase was primarily attributed to changes in working capital, including an increase in accounts payable and accrued expenses.
Research and development expenses for the nine months ended September 30, 2024, were $20.32 million, down from $23.72 million in the prior year period. This decrease was primarily driven by lower salaries, benefits, and consulting fees, partially offset by increased clinical trial expenses. Selling, general and administrative expenses were $28.10 million for the same period, down from $30.08 million in the prior year, due to reductions in areas like salaries, facilities costs, and professional fees.
As of September 30, 2024, Biora had $3.20 million in cash and cash equivalents, as well as $62.90 million in outstanding convertible notes. The company’s debt-to-equity ratio stood at -0.3619, with a current ratio and quick ratio both at 0.05. These figures highlight the company’s challenging liquidity position.
To address its capital needs, Biora has secured a $16 million multiple-draw facility from existing investors that it can access. However, the company has stated that its current cash resources are not expected to be sufficient to fund operations for at least the next 12 months, and it will require additional capital to continue its development programs.
Strategic Outlook and Future Plans
Despite the financial challenges, Biora Therapeutics remains focused on advancing its two therapeutic delivery platforms through clinical development. For the NaviCap platform and the BT-600 program, the company plans to present data from the successful Phase I clinical trial at the American College of Gastroenterology Annual Meeting in October 2024. Furthermore, Biora anticipates initiating a clinical study with BT-600 in ulcerative colitis patients towards the end of 2024. The goal of this study is to confirm the pharmacokinetic profile in UC patients and to inform dose selection for a subsequent induction efficacy trial.
Regarding the BioJet systemic therapeutics platform, Biora is in active partnership discussions with more than one large pharmaceutical company as part of their defined partnering process. The company remains on track towards its goal of securing a partnership for the BioJet platform in 2024, which could potentially provide a significant boost to its financial position and development capabilities.
Risks and Outlook
As a clinical-stage biotech company, Biora Therapeutics faces the inherent risks associated with the development and commercialization of novel therapeutic technologies. The success of the NaviCap™ and BioJet™ platforms is contingent on the company’s ability to navigate the regulatory landscape, secure strategic partnerships, and demonstrate the clinical and commercial viability of its products.
Additionally, the company’s limited financial resources and history of losses raise concerns about its ability to continue as a going concern. Failure to secure additional funding or successfully execute on its partnership strategy could jeopardize the company’s long-term prospects.
Despite these risks, Biora Therapeutics’ innovative approach to therapeutic delivery has garnered significant attention and interest from the industry. The positive Phase 1 results for BT-600 and the continued progress with the BioJet™ platform suggest that the company is well-positioned to make meaningful strides in addressing unmet needs in the treatment of IBDs and the delivery of complex therapeutics.
As Biora Therapeutics continues to navigate the challenges of a rapidly evolving biotech landscape, investors will closely monitor the company’s ability to translate its technological advancements into tangible commercial successes. The road ahead may be arduous, but Biora’s commitment to reimagining the future of therapeutic delivery holds the potential to transform the lives of patients worldwide.
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