Revelation Biosciences, Inc. (NASDAQ:REVB) is a clinical-stage biopharmaceutical company focused on the development and commercialization of immunologic therapeutics and diagnostics. The company's lead product candidates, GEM-AKI, GEM-CKD, and GEM-SSI, are based on its therapeutic platform that harnesses the power of trained immunity for the prevention and treatment of disease.

Business Overview

Revelation Biosciences was founded in May 2020 and has devoted substantially all of its resources to organizing and staffing the company, business planning, raising capital, and research and development of its product candidates. The company has funded its operations since inception through the issuance and sale of its capital stock, from which it has raised net proceeds of $49.3 million as of March 31, 2024.

Financials

For the three months ended March 31, 2024, Revelation Biosciences reported a net loss of $2.7 million. The company's annual net loss for the year ended December 31, 2023 was $120,254, with no revenue generated. The company's annual operating cash flow and free cash flow for the year ended December 31, 2023 were both negative $7.3 million.

Revelation Biosciences' research and development expenses increased by $0.2 million, from $0.5 million for the three months ended March 31, 2023 to $0.7 million for the three months ended March 31, 2024. The increase was primarily due to increases of $0.3 million in clinical study expenses related to GEM-AKI and GEM-SSI and $0.2 million in personnel expenses, offset by a decrease of $0.3 million in manufacturing expenses.

General and administrative expenses increased by $0.1 million, from $1.1 million for the three months ended March 31, 2023 to $1.2 million for the three months ended March 31, 2024. The increase was primarily due to increases of $0.3 million in personnel expenses, offset by a decrease of $0.2 million in legal and professional fees.

Liquidity

As of March 31, 2024, Revelation Biosciences had available cash and cash equivalents of $14.6 million and an accumulated deficit of $28.1 million. The company's current cash and cash equivalents balance will not be sufficient to complete all necessary product development or future commercialization efforts, and the company plans to seek additional funding through public or private equity or debt financings.

Recent Developments

In a major development, Revelation Biosciences announced positive data from its Phase 1 trial of its lead product candidate, Gemini. The study involved 40 healthy individuals between the ages of 18 and 55 who were given placebo, low, mid, and high doses of Gemini. The primary goals of the study were to determine the appropriate dosage for further studies and to evaluate the safety of Gemini, both of which were met.

Gemini was generally well tolerated, with adverse events increasing as the dose increased. Importantly, Gemini administration did not result in any significant changes in clinical safety markers. The company also noted that the mid-level dose is now established as the maximum tolerated dose in healthy volunteers.

Even more exciting were the data on key circulatory biomarkers from the study, which showed the expected positive results. Figures 1-4 in the company's announcement illustrate the reprogramming of the innate immune response after Gemini administration, with positive effects on biomarkers such as IL-1RA, NGAL, CRP, and IL-6.

CEO James Rolke commented

Revelation Biosciences' product candidates are based on the biology of phosphorylated hexaacyl disaccharide (PHAD) and its effect on the innate immune system. PHAD, a synthetic version of MPLA, is known to stimulate TLR-4, leading to the production of multiple types of cytokines and chemokines that modulate the activity of the innate and adaptive immune response.

The company's current therapeutic candidates, GEM-AKI, GEM-CKD, and GEM-SSI, are all based on the active ingredient PHAD and are being developed for the prevention and treatment of acute and chronic organ disease, as well as the prevention and treatment of infection.

Risks and Challenges

Revelation Biosciences faces several risks and challenges as it continues to develop its product candidates. The company has never generated revenue and does not expect to generate revenue from product sales unless and until it successfully completes development and obtains regulatory approval for its product candidates, which it expects will not be for at least several years, if ever.

Additionally, the company has incurred recurring losses since its inception, including a net loss of $2.7 million for the three months ended March 31, 2024. As of March 31, 2024, the company had an accumulated deficit of $28.1 million and available cash and cash equivalents of $14.6 million, which the company believes will not be sufficient to sustain operations within one-year after the date that the unaudited financial statements for March 31, 2024 were issued.

To continue as a going concern, Revelation Biosciences will need to raise additional capital resources, which it plans to do through public or private equity or debt financings. However, the company may not be able to obtain financing on acceptable terms, or at all, and the terms of any financing may adversely affect the holdings or the rights of the company's stockholders.

Outlook

Despite the challenges, Revelation Biosciences' experienced management team, led by CEO James Rolke, who has overseen six INDs and two marketing approvals, and the promising potential of the company's product candidates, make it a stock worth considering for investors. The positive data from the Phase 1 trial of Gemini is a significant catalyst for the company, and the planned Phase 1b study in patients later this year could provide further validation of the company's approach.

Conclusion

Investors should closely monitor Revelation Biosciences' progress as it continues to advance its product candidates through the clinical development process and navigate the challenges of bringing new therapies to market. The company's ability to secure additional funding and successfully execute its clinical development strategy will be crucial in determining its long-term success.