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 |
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Three Months Ended
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Six Months Ended
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2024 |
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2023 |
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2024 |
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2023 |
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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 |
|
|
|
|
|
|
|
|
|
|
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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 |
|
|
|
|
|
|
|
|
|
|
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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 |
|
|
|
|
|
|
|
|
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REVELATION BIOSCIENCES, INC. Condensed Consolidated Balance Sheets |
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June 30,
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December 31,
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ASSETS |
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Current assets: |
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|
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|
||||
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 |
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|
|
|
||||
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 |
|
