REVB Revelation Biosciences Inc

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