Revelation Biosciences, Inc. Announces Financial Results for the Three and Six Months Ended June 30, 2024

Rhea-AI Summary

Revelation Biosciences (NASDAQ: REVB), a clinical-stage biopharmaceutical company, reported its financial results for Q2 and H1 2024. Key highlights include:

- Completed dosing of first-in-human phase 1 clinical study of Gemini
- Announced positive phase 1 clinical data meeting primary safety endpoint
- Cash and cash equivalents of $12.1 million as of June 30, 2024
- Net loss of $8.4 million for Q2 2024, compared to $1.4 million in Q2 2023
- Net loss of $11.1 million for H1 2024, compared to net income of $4.7 million in H1 2023

The company believes its current cash position is sufficient to fund operations through 2024.

Positive

• Completed dosing of first-in-human phase 1 clinical study of Gemini
• Positive phase 1 clinical data of Gemini met primary safety endpoint
• Statistically significant dose-dependent upregulation of key biomarkers observed
• Cash and cash equivalents increased to $12.1 million from $12.0 million at year-end 2023
• Current cash position believed to be sufficient to fund operations through 2024

Negative

• Net loss increased to $8.4 million in Q2 2024 from $1.4 million in Q2 2023
• Net loss of $11.1 million in H1 2024 compared to net income of $4.7 million in H1 2023
• Net cash used for operating activities increased to $5.3 million in H1 2024 from $3.6 million in H1 2023

Insights

Financial Analyst

Revelation Biosciences' Q2 2024 financial results reveal a mixed picture. While the company reported progress in its clinical trials, particularly with Gemini, its financial position remains precarious. The $12.1 million cash position, only slightly up from year-end 2023, is concerning given the $5.3 million cash burn in H1 2024. The widening net loss of $8.4 million for Q2 2024, compared to $1.4 million in Q2 2023, indicates escalating expenses, likely due to increased R&D activities. The -47% change in diluted EPS ($5.13 vs $5.83) suggests significant dilution, potentially from fundraising efforts. Investors should closely monitor the company's cash runway and potential need for additional financing in 2025.

Medical Research Analyst

The completion of Gemini's first-in-human Phase 1 study marks a significant milestone for Revelation Biosciences. The positive safety profile and statistically significant biomarker activity are encouraging signs for the drug's potential. However, it's important to note that early-stage success doesn't guarantee late-stage efficacy. The planned Phase 1b study in CKD patients will be a critical next step to validate Gemini's therapeutic potential. Investors should be cautious about overinterpreting these early results and wait for more robust clinical data from larger, more diverse patient populations before drawing conclusions about Gemini's commercial viability.

Market Research Analyst

Revelation's focus on trained immunity and innate immune system modulation positions it in a niche but growing market. The positive Phase 1 results for Gemini could potentially attract partnership interest from larger pharmaceutical companies, which might be important for the company's long-term sustainability. However, the competitive landscape in immunomodulation is intense, with many well-funded players. Revelation's success will hinge on differentiating Gemini and potentially expanding its pipeline. The planned CKD study is a strategic move into a high-need area, but investors should be aware of the long development timelines and high costs associated with bringing novel immunotherapies to market.

SAN DIEGO--(BUSINESS WIRE)-- Revelation Biosciences, Inc. (NASDAQ: REVB) (the “Company” or “Revelation”), a clinical-stage biopharmaceutical company focused on harnessing the power of trained immunity for the prevention and treatment of disease by developing and commercializing therapeutics that modulate the innate immune system, today reported its three and six months ended June 30, 2024 financial results.

Corporate Highlights

• Completed dosing of its first in human phase 1 clinical study of Gemini
• Announced positive phase 1 clinical data of Gemini met the primary safety endpoint and showed statistically significant biomarker activity

“The Revelation team has worked hard in the first half of 2024 to continue to build the foundation for successful advancement of Gemini and we were excited to share that the primary endpoint to evaluate the safety and tolerability of escalating doses of Gemini was met, a maximum tolerated dose in healthy volunteers was identified and statistically significant dose dependent upregulation of key biomarkers was observed, demonstrating the immunostimulatory preconditioning effect of Gemini,” said James Rolke, Chief Executive Officer of Revelation. “During the second half of 2024, we look forward to building on this momentum with the start of a Phase 1b study in CKD patients.”

Results of Operations

As of June 30, 2024, Revelation had $12.1 million in cash and cash equivalents, compared to $12.0 million as of December 31, 2023. The increase in cash and cash equivalents was primarily due to net cash received from financing activities, offset primarily by cash used for operating activities. Based on current operating plans and projections, Revelation believes that its current cash and cash equivalents are sufficient to fund operations through 2024.

Revelation’s net cash used for operating activities for the six months ended June 30, 2024 was $5.3 million compared to net cash used for operating activities of $3.6 million for the same period in 2023. Revelation’s net loss for the three months ended June 30, 2024 was $8.4 million, or $5.13 basic and diluted net loss per share compared to a net loss of $1.4 million, or $5.83 basic and diluted net loss per share for the same period in 2023. Revelation’s net loss for the six months ended June 30, 2024 was $11.1 million, or $8.13 basic and diluted net loss per share compared to net income of $4.7 million, or $24.52 basic net earnings per share and $23.89 diluted net earnings per share for the same period in 2023, respectively.

About Gemini

Gemini is a proprietary formulation of phosphorylated hexaacyl disaccharide (PHAD®) for systemic administration. It is being developed for multiple indications including as a pretreatment to prevent or reduce the severity and duration of post-surgical infection (GEMINI-PSI program), as pretreatment to prevent or reduce the severity and duration of acute kidney injury (GEMINI-AKI program). In addition, Gemini may be a treatment to stop or slow the progression of chronic kidney disease (GEMINI-CKD program). Revelation believes Gemini works through trained immunity, which redirects and attenuates the innate immune response to external stress (infection, trauma, etc.). Revelation has conducted multiple preclinical studies demonstrating the therapeutic potential of Gemini in the target indications.

About Revelation Biosciences, Inc.

Revelation Biosciences, Inc. is a clinical stage life sciences company focused on harnessing the power of trained immunity for the prevention and treatment of disease using its proprietary formulation Gemini. Revelation has multiple ongoing programs to evaluate Gemini, including as a prevention for post-surgical infection, as a prevention for acute kidney injury, and for the treatment of chronic kidney disease.

For more information on Revelation, please visit www.RevBiosciences.com.

Forward-Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These forward-looking statements are generally identified by the words "anticipate", "believe", "expect", "estimate", "plan", "outlook", and "project" and other similar expressions. We caution investors that forward-looking statements are based on management’s expectations and are only predictions or statements of current expectations and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from those anticipated by the forward-looking statements. Revelation cautions readers not to place undue reliance on any such forward looking statements, which speak only as of the date they were made. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: the ability of Revelation to meet its financial and strategic goals, due to, among other things, competition; the ability of Revelation to grow and manage growth profitability and retain its key employees; the possibility that the Revelation may be adversely affected by other economic, business, and/or competitive factors; risks relating to the successful development of Revelation’s product candidates; the ability to successfully complete planned clinical studies of its product candidates; the risk that we may not fully enroll our clinical studies or enrollment will take longer than expected; risks relating to the occurrence of adverse safety events and/or unexpected concerns that may arise from data or analysis from our clinical studies; changes in applicable laws or regulations; expected initiation of the clinical studies, the timing of clinical data; the outcome of the clinical data, including whether the results of such study is positive or whether it can be replicated; the outcome of data collected, including whether the results of such data and/or correlation can be replicated; the timing, costs, conduct and outcome of our other clinical studies; the anticipated treatment of future clinical data by the FDA, the EMA or other regulatory authorities, including whether such data will be sufficient for approval; the success of future development activities for its product candidates; potential indications for which product candidates may be developed; the ability of Revelation to maintain the listing of its securities on NASDAQ; the expected duration over which Revelation’s balances will fund its operations; and other risks and uncertainties described herein, as well as those risks and uncertainties discussed from time to time in other reports and other public filings with the SEC by Revelation.

REVELATION BIOSCIENCES, INC. Condensed Consolidated Statements of Operations
		Three Months Ended June 30,								Six Months Ended June 30,
		2024				2023				2024				2023
Operating expenses:
Research and development		$	1,394,929			$	909,278			$	2,112,511			$	1,434,551
General and administrative			1,127,468				1,023,752				2,312,024				2,118,326
Total operating expenses			2,522,397				1,933,030				4,424,535				3,552,877
Loss from operations			(2,522,397	)			(1,933,030	)			(4,424,535	)			(3,552,877	)
Other income (expense):
Change in fair value of warrant liability			4,416				423,239				72,843				8,168,174
Other income (expense), net			(5,871,838	)			61,621				(6,719,560	)			95,728
Total other income (expense), net			(5,867,422	)			484,860				(6,646,717	)			8,263,902
Net (loss) earnings		$	(8,389,819	)		$	(1,448,170	)		$	(11,071,252	)		$	4,711,025
Net (loss) earnings per share, basic		$	(5.13	)		$	(5.83	)		$	(8.13	)		$	24.52
Weighted-average shares used to compute net (loss) earnings per share, basic			1,635,234				248,369				1,362,534				192,149
Net (loss) earnings per share, diluted		$	(5.13	)		$	(5.83	)		$	(8.13	)		$	23.89
Weighted-average shares used to compute net (loss) earnings per share, diluted			1,635,234				248,369				1,362,534				197,167

REVELATION BIOSCIENCES, INC. Condensed Consolidated Balance Sheets
		June 30, 2024				December 31, 2023
ASSETS
Current assets:
Cash and cash equivalents		$	12,073,058			$	11,991,701
Deferred offering costs			—				71,133
Prepaid expenses and other current assets			125,743				84,691
Total current assets			12,198,801				12,147,525
Property and equipment, net			70,774				65,084
Total assets		$	12,269,575			$	12,212,609
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable		$	1,281,323			$	1,359,898
Accrued expenses			8,454,139				1,152,460
Deferred underwriting commissions			1,382,848				2,911,260
Warrant liability			10,844				141,276
Total current liabilities			11,129,154				5,564,894
Total liabilities			11,129,154				5,564,894
Stockholders’ equity:
Common Stock, $0.001 par value; 500,000,000 shares authorized at June 30, 2024 and December 31, 2023 and 1,643,395 and 264,537 issued and outstanding at June 30, 2024 and December 31, 2023, respectively			1,643				265
Additional paid-in-capital			37,677,132				32,114,552
Accumulated deficit			(36,538,354	)			(25,467,102	)
Total stockholders’ equity			1,140,421				6,647,715
Total liabilities and stockholders’ equity		$	12,269,575			$	12,212,609

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20240809407415/en/

Sandra Vedrick

Vice President, Investor Relations & Human Resources

Revelation Biosciences, Inc.

Email: svedrick@revbiosciences.com

and

Chester Zygmont, III

Chief Financial Officer

Revelation Biosciences, Inc.

Email: czygmont@revbiosciences.com

Source: Revelation Biosciences, Inc.

FAQ

What were Revelation Biosciences' (REVB) financial results for Q2 2024?

Revelation Biosciences reported a net loss of $8.4 million, or $5.13 per share, for Q2 2024, compared to a net loss of $1.4 million, or $5.83 per share, in Q2 2023.

How much cash does Revelation Biosciences (REVB) have as of June 30, 2024?

As of June 30, 2024, Revelation Biosciences had $12.1 million in cash and cash equivalents.

What were the key clinical developments for Revelation Biosciences (REVB) in H1 2024?

Revelation Biosciences completed dosing of its first-in-human phase 1 clinical study of Gemini and announced positive phase 1 clinical data meeting the primary safety endpoint.

How long does Revelation Biosciences (REVB) expect its current cash to last?

Based on current operating plans and projections, Revelation Biosciences believes its current cash and cash equivalents are sufficient to fund operations through 2024.