Biora Therapeutics, a clinical-stage biotech company, is on a mission to reimagine the way therapeutics are delivered. With its two pioneering platforms, NaviCap™ and BioJet™, the company is poised to transform the treatment landscape by overcoming the limitations of traditional drug administration methods.
Biora's Journey From Genetics to Innovative Therapeutics
Biora Therapeutics, formerly known as Progenity, Inc., was founded in 2010 with a focus on genetic testing and diagnostics, serving women's health providers in the United States. The company initially specialized in genetic carrier screening and noninvasive prenatal testing, catering to obstetric, gynecological, fertility, and maternal fetal medicine specialties. Through its affiliation with Mattison Pathology, LLP (doing business as Avero Diagnostics), Biora also provided anatomic and molecular pathology testing products.
In June 2021, Biora underwent a significant strategic transformation, closing its legacy genetics laboratory and selling Avero Diagnostics. This pivotal decision marked a shift from its historical testing business, which had been the primary source of revenue, to focus entirely on developing its innovative therapeutic delivery platforms. The company's evolution continued in 2022 when it divested its single-molecule detection platform and formed a new entity, Enumera Molecular, Inc., in which Biora retained a minority ownership stake.
Throughout its history, Biora has faced various challenges, including regulatory scrutiny. In 2018, the company received civil investigative demands and subpoenas related to its legacy commercial practices, which were ultimately resolved through settlement agreements with governmental agencies in 2020. Despite these obstacles, Biora has persevered in its mission to revolutionize therapeutic delivery.
To advance its product development efforts, Biora has engaged in strategic licensing and collaboration agreements. Notable among these are the Preeclampsia Agreement in 2023 and the Northwest License Agreement in 2022, which have bolstered the company's capabilities and expanded its potential applications in the field of innovative drug delivery.
The NaviCap™ platform is designed to precisely deliver therapeutics to the site of disease in the gastrointestinal tract, with the aim of improving outcomes for patients with inflammatory bowel diseases (IBD) such as Crohn's disease and ulcerative colitis. The BioJet™ platform, on the other hand, promises to replace painful injections with a needle-free, oral delivery system for large molecule therapeutics, including biologics and peptides.
Navigating Regulatory Challenges and Securing Key Partnerships
Biora has faced its share of regulatory hurdles, as the company's product candidates, being drug-device combination products, require coordinated review by the FDA and similar foreign regulatory agencies. However, the company has proactively engaged with these authorities, leveraging the 505(b)(2) regulatory pathway for its NaviCap™ platform, which allows it to rely on existing data to expedite the development process.
To further strengthen its capabilities, Biora has forged strategic partnerships with large pharmaceutical companies, leveraging their expertise and resources to advance its therapeutic delivery platforms. These collaborations have not only provided valuable funding but also given Biora access to a broader pipeline of potential therapeutic candidates to integrate with its delivery technologies.
Financials and Operational Performance
Biora's financial performance has been impacted by the significant investments required to develop its innovative platforms. As of the latest reported quarter (Q3 2024), the company had $3.2 million in cash and cash equivalents, with a working capital deficit. The company has been actively seeking additional capital through equity offerings, debt financing, and collaborations to fund its ongoing operations and product development efforts.
For the most recent fiscal year (2023), Biora reported revenue of $4,000, with a net loss of $124.1 million. Operating cash flow for the year was negative $48.5 million, while free cash flow stood at negative $48.6 million. In the most recent quarter (Q3 2024), the company reported revenue of $32,000 and a net loss of $18.4 million. The year-over-year revenue growth for Q3 could not be calculated due to the absence of prior Q3 revenue.
Notably, revenues increased by less than $0.1 million compared to the prior year quarter, primarily due to an increase in collaboration revenue. The net loss decreased significantly by $55.1 million compared to the prior year quarter, mainly attributed to a decrease in one-time charges and changes in the fair value of derivatives and warrants.
In terms of operational performance, Biora has made significant strides in advancing its product candidates. For its NaviCap™ platform, the company has reported positive results from early-stage clinical trials, demonstrating the ability to precisely deliver therapeutics to the colon while minimizing systemic exposure. This has paved the way for further development and potential partnerships with pharmaceutical companies.
Regarding the BioJet™ platform, Biora has successfully reduced the size of its ingestible device to a 00-size, which is highly desirable for both patients and potential partners. The company has reported strong interest from major pharmaceutical companies and is actively pursuing collaborations to leverage its needle-free delivery technology.
Liquidity and Nasdaq Compliance
As of September 30, 2024, Biora's financial position showed signs of strain. The company reported a debt-to-equity ratio of -0.37, cash and cash equivalents of $3.2 million, and restricted cash of $0.2 million. Both the current ratio and quick ratio stood at 0.05, indicating potential liquidity challenges. The company did not disclose any available credit lines.
Biora's journey has not been without its challenges. The company has faced regulatory uncertainties, particularly around the classification and review process for its drug-device combination products. This has required the company to navigate a complex regulatory landscape and work closely with the FDA to ensure compliance.
Additionally, Biora has encountered issues maintaining compliance with Nasdaq's listing requirements, primarily related to the minimum market value of listed securities. The company received a notice from Nasdaq in December 2023, indicating that it no longer met the $50 million market value threshold. Biora was granted extensions by Nasdaq to regain compliance, and as of the latest update, the company remains listed on the exchange while working to address this issue.
Looking Ahead Unlocking the Potential of Innovative Delivery Technologies
Despite the challenges, Biora remains focused on advancing its therapeutic delivery platforms and unlocking their full potential. The company's strong pipeline, strategic partnerships, and commitment to innovation position it well to capitalize on the growing demand for novel drug delivery solutions.
Biora's product portfolio is divided into two primary segments: Targeted Oral Delivery and Systemic Oral Delivery. The Targeted Oral Delivery segment, featuring the NaviCap™ platform, focuses on delivering therapeutics directly to the site of disease in the gastrointestinal tract. The lead product candidate in this segment is BT-600, a GI-targeted tofacitinib, which is currently in early-stage clinical development.
The Systemic Oral Delivery segment, centered around the BioJet™ platform, aims to enable needle-free, oral delivery of large molecule therapeutics, such as biologics. The lead product candidate in this segment is BT-1, also in early-stage clinical development.
For the nine months ended September 30, 2024, Biora reported total operating expenses of $48.4 million, a decrease of $5.4 million compared to the same period in the prior year. This reduction was primarily driven by decreases in research and development (R&D) expenses of $3.4 million and selling, general and administrative (SG&A) expenses of $2 million.
As Biora continues to navigate the regulatory landscape and secure the necessary funding, the successful development and commercialization of its NaviCap™ and BioJet™ platforms could significantly impact the treatment of various diseases, from inflammatory bowel conditions to the delivery of large molecule therapeutics. The company's ability to overcome its current obstacles and execute its strategic vision will be crucial in determining its long-term success.
In conclusion, Biora Therapeutics is at the forefront of a revolution in therapeutic delivery, leveraging its innovative smart pill technologies to address unmet needs and improve patient outcomes. Investors and industry stakeholders will closely follow the company's progress as it continues to push the boundaries of what is possible in the world of drug delivery.