Revelation Biosciences, Inc. Announces Financial Results for the Three and Twelve Months Ended December 31, 2023
- Completion of a $6.2 million public offering.
- Initiation of a Phase 1 clinical study of Gemini.
- Presentation of positive nonclinical data on Gemini's impact on acute kidney injury.
- Increase in cash and cash equivalents to $12.0 million as of December 31, 2023, compared to $5.3 million in 2022.
- Net loss of $2.2 million for the three months ended December 31, 2023, with a basic and diluted net loss per share of $8.33.
- Net loss of $0.1 million for the twelve months ended December 31, 2023, with a basic and diluted net loss per share of $0.53.
- Increased net cash used for operating activities.
- Increase in net loss compared to the same period in 2022.
- Pre-clinical and clinical preparation costs impacting net cash used for operating activities.
- Decreased clinical study expenses for Phase 2b viral challenge clinical study and Phase 1b allergen challenge study.
- Change in fair value of the warrant liability creating a $8.3 million gain.
Insights
Revelation Biosciences' financial results indicate a strategic shift towards advancing their clinical programs, particularly Gemini. The completion of a $6.2 million public offering is a significant liquidity event that has bolstered the company's cash position to $12.0 million. This positions the company to fund operations through 2024, which is vital for investor confidence in the company's ability to continue its clinical trials without the immediate need for additional capital raises that could dilute existing shareholders.
The reported reduction in net loss from $10.8 million to $0.1 million year-over-year is a positive indicator of the company's improved financial management and the impact of non-operational factors such as the change in fair value of the warrant liability. However, investors should remain cautious as the company is still operating at a loss and the gain from the warrant liability is non-cash and may not be indicative of operational efficiency improvements.
The initiation of the Phase 1 clinical study for Gemini signifies a critical step in Revelation Biosciences' product pipeline. The positive preclinical acute kidney injury (AKI) results suggest potential for Gemini, which could address a significant unmet medical need if the clinical data aligns with preclinical findings. The focus on trained immunity is a novel approach in the biopharmaceutical industry and could potentially lead to a new class of therapeutics.
From a research perspective, the transition from preclinical to clinical phases is fraught with uncertainties and the success of Gemini in human trials is not guaranteed. Investors should be aware of the risks inherent in clinical development, particularly for early-stage biotechnology companies. The company's ability to advance Gemini through clinical trials will be a key determinant of its future valuation and potential revenue streams.
Corporate Highlights
-
Completed a
$6.2 million - Commencement of first in human Phase 1 clinical study of Gemini at the beginning of March.
- Oral presentation and poster of nonclinical data demonstrating Gemini reduces the severity and duration of acute kidney injury in an ischemia reperfusion model at the 29th International Conference on Advances in Critical Care Nephrology this month.
“The Revelation team has worked hard over 2023 to build the foundation for successful advancement of Gemini and we are delighted with being able to share the positive preclinical AKI results and the start of our Phase 1 study,” said James Rolke, Chief Executive Officer of Revelation. “During 2024, we look forward to building on this momentum and advancing evaluation of Gemini into patients.”
Results of Operations
As of December 31, 2023, Revelation had
Revelation’s net cash used for operating activities for the three and twelve months ended December 31, 2023 was
The changes in net cash used for operating activities and the increase in net loss for the three months ended December 31, 2023 as compared to December 31, 2022 was primarily due to pre-clinical costs and clinical preparation costs primarily for programs GEM-SSI and GEM-AKI.
The changes in net cash used for operating activities for the twelve months ended December 31, 2023 as compared to December 31, 2022 were primarily due to decreased clinical study expenses associated with our Phase 2b viral challenge clinical study (REVTx-99a) and our Phase 1b allergen challenge study (REVTx-99b), legal fees, professional consulting service fees and public company directors and officers insurance policy. The decrease in net loss for the twelve months ended December 31, 2023 as compared to December 31, 2022 were primarily due to the change in fair value of the warrant liability creating a
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-SSI 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 hospital acquired infection and as a prevention for acute kidney injury.
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 clinical utility of an increase in intranasal cytokine levels as a biomarker of viral infections; 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 potential impact that COVID-19 may have on Revelation’s suppliers, vendors, regulatory agencies, employees and the global economy as a whole; the ability of Revelation to maintain the listing of its securities on NASDAQ; investor sentiment relating to SPAC related going public transactions; 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. Consolidated Statements of Operations |
||||||||||||||||
|
|
Three Months Ended December 31, |
|
Year Ended December 31, |
||||||||||||
|
|
2023 |
|
2022 |
|
2023 |
|
2022 |
||||||||
Operating expenses: |
|
|
|
|
|
|
|
|
||||||||
Research and development |
|
$ |
1,059,984 |
|
|
$ |
339,971 |
|
|
$ |
4,145,902 |
|
|
$ |
5,377,400 |
|
General and administrative |
|
|
1,265,906 |
|
|
|
878,356 |
|
|
|
4,510,762 |
|
|
|
5,487,111 |
|
Total operating expenses |
|
|
2,325,890 |
|
|
|
1,218,327 |
|
|
|
8,656,664 |
|
|
|
10,864,511 |
|
Loss from operations |
|
|
(2,325,890 |
) |
|
|
(1,218,327 |
) |
|
|
(8,656,664 |
) |
|
|
(10,864,511 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
||||||||
Change in fair value of warrant liability |
|
|
68,202 |
|
|
|
— |
|
|
|
8,328,937 |
|
|
|
— |
|
Other income (expense) |
|
|
54,785 |
|
|
|
10,741 |
|
|
|
207,473 |
|
|
|
34,962 |
|
Total other income (expense), net |
|
|
122,987 |
|
|
|
10,741 |
|
|
|
8,536,410 |
|
|
|
34,962 |
|
Net loss |
|
$ |
(2,202,903 |
) |
|
$ |
(1,207,586 |
) |
|
$ |
(120,254 |
) |
|
$ |
(10,829,549 |
) |
|
|
|
|
|
|
|
|
|
||||||||
Net loss per share, basic and diluted |
|
$ |
(8.33 |
) |
|
$ |
(15.61 |
) |
|
$ |
(0.53 |
) |
|
$ |
(149.20 |
) |
Weighted-average shares used to compute net loss per share, basic and diluted |
|
|
264,537 |
|
|
|
77,375 |
|
|
|
228,641 |
|
|
|
72,585 |
|
REVELATION BIOSCIENCES, INC. Consolidated Balance Sheets |
||||||||
|
|
December 31, 2023 |
|
December 31, 2022 |
||||
ASSETS |
|
|
|
|
||||
Current assets: |
|
|
|
|
||||
Cash and cash equivalents |
|
$ |
11,991,701 |
|
|
$ |
5,252,979 |
|
Deferred offering costs |
|
|
71,133 |
|
|
|
87,171 |
|
Prepaid expenses and other current assets |
|
|
84,691 |
|
|
|
73,132 |
|
Total current assets |
|
|
12,147,525 |
|
|
|
5,413,282 |
|
Property and equipment, net |
|
|
65,084 |
|
|
|
90,133 |
|
Total assets |
|
$ |
12,212,609 |
|
|
$ |
5,503,415 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
||||
Current liabilities: |
|
|
|
|
||||
Accounts payable |
|
$ |
1,359,898 |
|
|
$ |
554,205 |
|
Accrued expenses |
|
|
1,152,460 |
|
|
|
985,497 |
|
Deferred underwriting commissions |
|
|
2,911,260 |
|
|
|
2,911,260 |
|
Warrant liability |
|
|
141,276 |
|
|
|
— |
|
Total current liabilities |
|
|
5,564,894 |
|
|
|
4,450,962 |
|
Total liabilities |
|
|
5,564,894 |
|
|
|
4,450,962 |
|
Stockholders’ equity: |
|
|
|
|
||||
Series A Preferred Stock, |
|
|
— |
|
|
|
— |
|
Common Stock, |
|
|
265 |
|
|
|
77 |
|
Additional paid-in-capital |
|
|
32,114,552 |
|
|
|
26,399,224 |
|
Accumulated deficit |
|
|
(25,467,102 |
) |
|
|
(25,346,848 |
) |
Total stockholders’ equity |
|
|
6,647,715 |
|
|
|
1,052,453 |
|
Total liabilities and stockholders’ equity |
|
$ |
12,212,609 |
|
|
$ |
5,503,415 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20240322925709/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.
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