Core Insights - Revelation Biosciences, Inc. has successfully submitted and received acceptance for the end-of-phase 1 meeting package to the FDA [1] - The company is on track to hold the meeting later this year, which aims to gather agency feedback on the clinical development and regulatory approval pathway for Gemini as a treatment for acute kidney injury (AKI) [1] Company Developments - The primary focus of the meeting with the FDA is to establish feedback regarding the clinical development of Gemini [1] - The company is positioned as a clinical-stage life sciences entity concentrating on rebalancing inflammation [1]

Financial Position - As of September 30, 2025, Revelation had $12.7 million in cash and cash equivalents, up from $6.5 million as of December 31, 2024, primarily due to net cash proceeds from a public offering and warrant inducement[2]. - The total assets of Revelation as of September 30, 2025, were $12.86 million, compared to $6.62 million as of December 31, 2024[12]. - Revelation's accumulated deficit as of September 30, 2025, was $(46.91) million, up from $(40.51) million as of December 31, 2024[12]. Operating Performance - Net cash used for operating activities for the nine months ended September 30, 2025, was $6.3 million, a significant decrease from $14.6 million for the same period in 2024[2]. - Revelation's net loss for the three months ended September 30, 2025, was $1.9 million, or $(1.77) per share, compared to a net loss of $2.2 million, or $(40.15) per share for the same period in 2024[2][10]. - For the nine months ended September 30, 2025, the net loss was $6.4 million, or $(9.76) per share, compared to a net loss of $13.3 million, or $(354.05) per share for the same period in 2024[2][10]. - Total operating expenses for the three months ended September 30, 2025, were $1.94 million, compared to $1.80 million for the same period in 2024[10]. Development Focus - The company is focused on the development of Gemini, which aims to treat acute kidney injury, chronic kidney disease, and other inflammatory conditions[4][7]. - Revelation plans to meet with the FDA later this year to discuss the clinical development path for Gemini[2]. Fundraising Activities - Revelation received gross proceeds of $9.6 million from warrant inducement in September 2025[5].

Core Insights - Revelation Biosciences, Inc. reported financial results for the three and nine months ended September 30, 2025, highlighting significant corporate developments [1] Financial Performance - The company received gross proceeds of $9.6 million from warrant inducement in September 2025, indicating strong financial backing [1] Clinical Developments - Revelation announced groundbreaking top-line results from the PRIME Clinical Study, which are expected to advance the company's development phase [1] Leadership Commentary - CEO James Rolke emphasized that the outstanding PRIME data and subsequent financing validate the potential of Gemini, positioning the company on solid footing for future advancements [1]

Financial Performance - The company incurred a net loss of $6.4 million for the nine months ended September 30, 2025, compared to a net loss of $13.3 million for the same period in 2024[99]. - The company has incurred recurring losses since inception, with net losses expected to fluctuate significantly based on clinical study timing and expenditures[99]. - The company incurred a net loss of $6.4 million for the nine months ended September 30, 2025, with an accumulated deficit of $46.9 million[122]. - Significant operating and net losses are expected to continue as the company expands research and development activities[122]. Cash Position - As of September 30, 2025, the company had cash and cash equivalents of $12.7 million and an accumulated deficit of $46.9 million[118]. - Cash and cash equivalents available as of September 30, 2025, were $12.7 million, which is insufficient to sustain operations for one year[122]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $6.3 million, a decrease from $14.6 million in the same period of 2024[125][127]. - Net cash provided by financing activities for the nine months ended September 30, 2025, was $12.5 million, primarily from a public offering and warrant inducement[129]. - There were no net cash provided by or used in investing activities during the nine months ended September 30, 2025[128]. Expenses - Research and development expenses increased by $0.2 million, from $2.9 million for the nine months ended September 30, 2024, to $3.1 million for the same period in 2025[112]. - General and administrative expenses increased by $0.1 million, from $3.3 million for the nine months ended September 30, 2024, to $3.4 million for the same period in 2025[114]. - Total operating expenses for the nine months ended September 30, 2025, were $6.5 million, compared to $6.2 million for the same period in 2024[110]. - The company expects research and development expenses to increase substantially as it continues the development of product candidates[106]. Revenue Generation - The company has never generated revenue and does not expect to do so until product candidates successfully complete development and obtain regulatory approval[101]. - The company has never generated revenue and does not expect to do so until product candidates receive regulatory approval, which may take several years[122]. Funding and Capital - The company plans to seek additional funding through public or private equity or debt financings[98]. - The company plans to seek additional funding through public or private equity or debt financings to continue operations[123]. - The company may face dilution of existing stockholders' interests if additional capital is raised through equity offerings[121]. Off-Balance Sheet Arrangements - The company has no off-balance sheet arrangements as of September 30, 2025[132].

Core Points - Revelation Biosciences, Inc. has adjourned its 2025 Special Meeting of Stockholders due to insufficient shares present for voting [1] - The Special Meeting was originally scheduled for October 15, 2025, and will now reconvene on October 29, 2025, at 12:00 p.m. [1] Company Summary - Revelation Biosciences, Inc. is a clinical-stage life sciences company focused on rebalancing inflammation [1]

Core Insights - Revelation Biosciences, Inc. has entered into a definitive agreement for the immediate exercise of certain outstanding warrants to purchase up to 4,355,000 shares of common stock at an exercise price of $2.20 per share [1] Company Summary - The company is a clinical-stage life sciences firm focused on rebalancing inflammation [1] - The existing warrants were issued on May 29, 2025, and the shares are registered under an effective registration statement on Form S-1 [1]

Core Insights - Revelation Biosciences, Inc. is focused on rebalancing inflammation and has made significant progress in its Phase 1b PRIME clinical study for stage 3 and 4 chronic kidney disease (CKD) patients [1] - The primary endpoint of the study, which evaluates the safety and tolerability of escalating doses of Gemini, has been successfully met [1] - The company is set to host a corporate update webcast/conference call to discuss the groundbreaking activity data from the clinical study [1] Company Overview - Revelation Biosciences, Inc. is a clinical-stage life sciences company [1] - The company aims to potentially revolutionize the treatment of acute and chronic inflammatory diseases through its innovative approach [1] Clinical Study Details - The Phase 1b PRIME clinical study focuses on patients with stage 3 and 4 CKD [1] - The study's results indicate a normalization of the inflammatory response at the cellular level in these patients [1]

Core Viewpoint - Revelation Biosciences, Inc. is a clinical-stage life sciences company focused on rebalancing inflammation and is hosting a webcast on September 10th at 8:30 am Eastern Time to review data [1] Company Information - The company is listed on NASDAQ under the ticker REVB [1] - The webcast can be accessed online or by calling a toll-free number in the US or an international number [1] - A participant access code is provided for joining the webcast [1]

[Financial Results Announcement & Corporate Update](index=1&type=section&id=Financial%20Results%20Announcement%20%26%20Corporate%20Update) Revelation Biosciences announced Q2/H1 2025 financial results, highlighting its clinical-stage focus on rebalancing inflammation [Q2/H1 2025 Financial Results Announcement](index=1&type=section&id=Q2%2FH1%202025%20Financial%20Results%20Announcement) Revelation Biosciences, Inc. announced its Q2/H1 2025 financial results, emphasizing its clinical-stage focus on rebalancing inflammation - Revelation Biosciences, Inc. (NASDAQ: REVB) reported financial results for the three and six months ended June 30, 2025, as a clinical-stage life sciences company focused on rebalancing inflammation[1](index=1&type=chunk) [Corporate Highlights and Cash Position](index=1&type=section&id=Corporate%20Highlights%20and%20Cash%20Position) CEO highlighted strategic financial management and Gemini program advancement, with cash and equivalents at **$5.2 million** as of June 30, 2025 - CEO James Rolke emphasized strategic financial resource maximization and advancing the Gemini program, with Phase 1b data expected this quarter and FDA engagement later this year[2](index=2&type=chunk) Cash and Cash Equivalents | Date | Amount (Millions USD) | | :--- | :--- | | June 30, 2025 | $5.2 | | December 31, 2024 | $6.5 | *Decrease primarily due to cash used for operating activities.* - Current cash and cash equivalents are believed to be sufficient to fund operations through December 2025[2](index=2&type=chunk) [Summary of Financial Operations](index=1&type=section&id=Summary%20of%20Financial%20Operations) Revelation Biosciences reported reduced net loss and lower net cash used for operating activities in Q2/H1 2025 compared to 2024 [Key Financial Metrics (Q2 & H1 2025 vs. 2024)](index=1&type=section&id=Key%20Financial%20Metrics%20%28Q2%20%26%20H1%202025%20vs.%202024%29) The company demonstrated improved financial performance with reduced net loss and decreased cash used in operations for Q2 and H1 2025 Net Cash Used for Operating Activities | Period | 2025 (Millions USD) | 2024 (Millions USD) | Change (YoY) | | :--- | :--- | :--- | :--- | | Three Months Ended June 30 | $4.7 | $5.3 | -$0.6M (Decrease) | *Net cash used for operating activities decreased by $0.6 million for the three months ended June 30, 2025, compared to 2024.* Net Loss and EPS | Period | Metric | 2025 | 2024 | Change (YoY) | | :--- | :--- | :--- | :--- | :--- | | Three Months Ended June 30 | Net Loss | $(2.4)M | $(8.4)M | $(6.0)M (Reduced Loss) | | | Basic & Diluted Net Loss Per Share | $(7.01) | $(246.27) | $(239.26) (Reduced Loss) | | Six Months Ended June 30 | Net Loss | $(4.5)M | $(11.1)M | $(6.6)M (Reduced Loss) | | | Basic & Diluted Net Loss Per Share | $(13.60) | $(390.02) | $(376.42) (Reduced Loss) | *Net loss significantly decreased for both periods in 2025 compared to 2024.* [Gemini Program: Product & Clinical Development](index=1&type=section&id=Gemini%20Program%3A%20Product%20%26%20Clinical%20Development) The Gemini program focuses on an intravenously administered PHAD® formulation to reduce inflammation, with positive preclinical and Phase 1 clinical data [About Gemini](index=1&type=section&id=About%20Gemini) Gemini is an intravenously administered PHAD® formulation designed to reduce inflammation by reprogramming the innate immune system for multiple indications - Gemini is an intravenously administered, proprietary formulation of PHAD® that reduces inflammation damage by reprogramming the innate immune system[4](index=4&type=chunk) - Gemini is being developed for multiple indications: prevention/reduction of acute kidney injury (GEMINI-AKI), post-surgical infection (GEMINI-PSI), infection post severe burn (GEMINI-PBI), and treatment of chronic kidney disease (GEMINI-CKD)[5](index=5&type=chunk) [Clinical Development and Recent Achievements](index=1&type=section&id=Clinical%20Development%20and%20Recent%20Achievements) Preclinical and Phase 1 data show Gemini's therapeutic potential, with recent achievements including completing Phase 1b dosing and a **$4 million** public offering - Multiple preclinical studies have demonstrated Gemini's therapeutic potential in target indications[6](index=6&type=chunk) - Positive Phase 1 clinical data for intravenous Gemini treatment met the primary safety endpoint and showed statistically significant pharmacodynamic activity, including upregulation of IL-10[6](index=6&type=chunk)[7](index=7&type=chunk) - Completed dosing of patients in PRIME Phase 1b Clinical Study of Gemini in CKD Patients[6](index=6&type=chunk) - Received gross proceeds of **$4 million** from public offering in May 2025[6](index=6&type=chunk) [Consolidated Financial Statements](index=4&type=section&id=Consolidated%20Financial%20Statements) The consolidated statements reflect a significant reduction in net loss for Q2/H1 2025, primarily due to a positive shift in other income/expense [Consolidated Statements of Operations](index=4&type=section&id=Consolidated%20Statements%20of%20Operations) The statements show a significant reduction in net loss for Q2/H1 2025, driven by a positive shift in "Other income (expense), net" Key Operating Expenses (Three Months Ended June 30) | Expense Category | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Research and development | $1,317,980 | $1,394,929 | -$76,949 | | General and administrative | $1,143,249 | $1,127,468 | +$15,781 | | Total operating expenses | $2,461,229 | $2,522,397 | -$61,168 | *Total operating expenses slightly decreased for the three months ended June 30, 2025.* Key Operating Expenses (Six Months Ended June 30) | Expense Category | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Research and development | $2,176,810 | $2,112,511 | +$64,299 | | General and administrative | $2,379,406 | $2,312,024 | +$67,382 | | Total operating expenses | $4,556,216 | $4,424,535 | +$131,681 | *Total operating expenses slightly increased for the six months ended June 30, 2025.* Net Loss and Other Income (Expense) | Period | Metric | 2025 | 2024 | | :--- | :--- | :--- | :--- | | Three Months Ended June 30 | Net Loss | $(2,444,382) | $(8,389,819) | | | Total other income (expense), net | $16,847 | $(5,867,422) | | Six Months Ended June 30 | Net Loss | $(4,495,467) | $(11,071,252) | | | Total other income (expense), net | $60,749 | $(6,646,717) | *The significant reduction in net loss is largely attributable to a positive shift in "Total other income (expense), net" from a large expense in 2024 to a small income in 2025.* [Consolidated Balance Sheets](index=5&type=section&id=Consolidated%20Balance%20Sheets) Total assets decreased to **$5.395 million** as of June 30, 2025, primarily due to reduced cash, with corresponding decreases in liabilities and equity Key Balance Sheet Items | Item | June 30, 2025 | December 31, 2024 | Change | | :--- | :--- | :--- | :--- | | Cash and cash equivalents | $5,173,871 | $6,499,018 | -$1,325,147 | | Total current assets | $5,359,920 | $6,565,717 | -$1,205,797 | | Total assets | $5,395,090 | $6,622,049 | -$1,226,959 | | Total current liabilities | $1,569,306 | $1,913,667 | -$344,361 | | Total stockholders' equity | $3,825,784 | $4,708,382 | -$882,598 | *The balance sheet reflects a decrease in total assets, driven by lower cash, and a corresponding decrease in total liabilities and stockholders' equity.* - Common Stock shares issued and outstanding increased significantly from **174,104** at December 31, 2024, to **1,534,637** at June 30, 2025, reflecting the public offering in May 2025[6](index=6&type=chunk)[14](index=14&type=chunk) [Corporate Information & Disclosures](index=3&type=section&id=Corporate%20Information%20%26%20Disclosures) This section provides company information, forward-looking statements, and contact details [About Revelation Biosciences, Inc.](index=3&type=section&id=About%20Revelation%20Biosciences%2C%20Inc.) Revelation Biosciences is a clinical-stage life sciences company leveraging trained immunity with its proprietary Gemini formulation for disease prevention and treatment - Revelation Biosciences, Inc. is a clinical-stage life sciences company focused on trained immunity for disease prevention and treatment using its proprietary Gemini formulation[8](index=8&type=chunk) - The company has multiple ongoing programs evaluating Gemini for post-surgical infection prevention, acute kidney injury prevention, and chronic kidney disease treatment[8](index=8&type=chunk) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This section cautions investors about inherent risks and uncertainties that could cause actual results to differ materially from projections - The press release contains forward-looking statements, identified by words like "anticipate," "believe," "expect," and "project," which are subject to known and unknown risks and uncertainties[10](index=10&type=chunk) - Key risks include the ability to meet financial goals, manage growth, retain employees, successfully develop product candidates, complete clinical studies, obtain regulatory approvals, and the duration of funding[10](index=10&type=chunk) [Company Contacts](index=6&type=section&id=Company%20Contacts) Contact information for investor relations and the Chief Financial Officer is provided for inquiries - Investor Relations: Mike Porter (Porter LeVay & Rose Inc., mike@plrinvest.com)[15](index=15&type=chunk) - Chief Financial Officer: Chester Zygmont, III (Revelation Biosciences Inc., czygmont@revbiosciences.com)[15](index=15&type=chunk)

PART I—FINANCIAL INFORMATION [Item 1. Condensed Consolidated Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) Unaudited condensed consolidated financial statements detail the company's financial position, performance, and cash flows [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) | Metric | June 30, 2025 | December 31, 2024 | Change (%) | | :-------------------------------- | :------------ | :---------------- | :--------- | | Cash and cash equivalents | **$5,173,871** | **$6,499,018** | **-20.4%** | | Total current assets | **$5,359,920** | **$6,565,717** | **-18.4%** | | Total assets | **$5,395,090** | **$6,622,049** | **-18.5%** | | Total current liabilities | **$1,569,306** | **$1,913,667** | **-18.0%** | | Accumulated deficit | **$(45,001,105)** | **$(40,505,638)** | **+11.1%** | | Total stockholders' equity | **$3,825,784** | **$4,708,382** | **-18.7%** | - Common Stock shares outstanding increased significantly from **174,104** at December 31, 2024, to **1,534,637** at June 30, 2025[8](index=8&type=chunk) [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Change ($) | Change (%) | | :--------------------------------- | :------------------------------- | :------------------------------- | :--------- | :--------- | | Research and development | $1,317,980 | $1,394,929 | $(76,949) | -5.5% | | General and administrative | $1,143,249 | $1,127,468 | $15,781 | +1.4% | | Total operating expenses | $2,461,229 | $2,522,397 | $(61,168) | -2.4% | | Net loss | $(2,444,382) | $(8,389,819) | $5,945,437 | -70.9% | | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change ($) | Change (%) | | :--------------------------------- | :------------------------------- | :------------------------------- | :--------- | :--------- | | Research and development | $2,176,810 | $2,112,511 | $64,299 | +3.0% | | General and administrative | $2,379,406 | $2,312,024 | $67,382 | +2.9% | | Total operating expenses | $4,556,216 | $4,424,535 | $131,681 | +3.0% | | Net loss | $(4,495,467) | $(11,071,252) | $6,575,785 | -59.4% | - Net loss per share, basic and diluted, for the six months ended June 30, 2025, was **$(13.60)**, a significant improvement from **$(390.02)** in the prior year[11](index=11&type=chunk) [Condensed Consolidated Statements of Changes in Stockholders' Equity](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders%27%20Equity) | Item | Balance as of Dec 31, 2024 | Balance as of June 30, 2025 | | :------------------------------------------ | :------------------------- | :-------------------------- | | Common Stock (shares) | 174,104 | 1,534,637 | | Common Stock (amount) | $174 | $1,535 | | Additional Paid-in Capital | $45,213,846 | $48,825,354 | | Accumulated Deficit | $(40,505,638) | $(45,001,105) | | Total Stockholders' Equity | $4,708,382 | $3,825,784 | - The May 2025 Public Offering resulted in the issuance of **225,000** shares of common stock and generated **$3,388,244** in proceeds[13](index=13&type=chunk) - Class H Pre-funded Warrant exercises led to the issuance of **988,334** shares of common stock for a total purchase price of **$297**[13](index=13&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----------------------------------- | :------------------------------- | :------------------------------- | | Net cash used in operating activities | $(4,713,688) | $(5,316,651) | | Net cash used in investing activities | $0 | $(19,172) | | Net cash provided by financing activities | $3,388,541 | $5,417,180 | | Net (decrease) increase in cash and cash equivalents | $(1,325,147) | $81,357 | | Cash and cash equivalents at end of period | $5,173,871 | $12,073,058 | - Non-cash financing activities included **$3,094,680** from alternative cashless exercise of Class F Common Stock Warrants and **$11,546,080** for issuance of Class H Common Stock Warrants[16](index=16&type=chunk) [Notes to the Unaudited Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20the%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) [1. Organization and Basis of Presentation](index=7&type=section&id=1.%20Organization%20and%20Basis%20of%20Presentation) Revelation Biosciences is a clinical-stage life science company facing going concern doubt due to a **$45.0 million** accumulated deficit - Revelation Biosciences is a clinical-stage life science company focused on rebalancing inflammation using its proprietary formulation Gemini, with product candidates including GEM-AKI, GEM-CKD, and GEM-PSI[19](index=19&type=chunk) - The company effected a **1-for-16** reverse stock split on January 28, 2025, and a **1-for-3** reverse stock split on July 7, 2025[21](index=21&type=chunk) - The company incurred a net loss of **$4.5 million** for the six months ended June 30, 2025, and had an accumulated deficit of **$45.0 million**, raising substantial doubt about its ability to continue as a going concern[22](index=22&type=chunk) [2. Summary of Significant Accounting Policies](index=8&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) Significant accounting policies are consistent with the 2024 Annual Report, with no material impact from recent pronouncements - No changes to the Company's significant accounting policies described in the Annual Report on Form **10-K** for the year ended December 31, 2024[27](index=27&type=chunk) - Basic and diluted net loss per share are identical in net loss periods because potential common shares are anti-dilutive[28](index=28&type=chunk) - Recently issued accounting pronouncements are not expected to have a material impact on the Company's condensed consolidated financial statements[29](index=29&type=chunk) [3. Balance Sheet Details](index=9&type=section&id=3.%20Balance%20Sheet%20Details) Prepaid expenses increased to **$186,049** while accrued expenses decreased to **$739,626** due to changes in payroll and insurance | Account | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Prepaid expenses and other current assets | $186,049 | $66,699 | | Accrued expenses | $739,626 | $1,127,800 | | Accrued payroll and related expenses | $404,090 | $835,724 | [4. Commitments and Contingencies](index=9&type=section&id=4.%20Commitments%20and%20Contingencies) The company has month-to-month lease commitments, no material contractual obligations, and no material legal proceedings - The Company leases office space for **$151** per month and laboratory space for **$5,350** per month, both on a month-to-month basis[32](index=32&type=chunk) - Contracts with third-party service providers are generally cancellable and not considered material contractual obligations[33](index=33&type=chunk) - The Company is not a party to any material legal proceedings[34](index=34&type=chunk) [5. Financings](index=9&type=section&id=5.%20Financings) Recent public offerings generated **$5.4 million** and **$3.4 million** net cash, triggering warrant down-round provisions and a **$3.2 million** deemed dividend - The February 2024 Public Offering generated net cash proceeds of **$5.4 million**[35](index=35&type=chunk) - The May 2025 Public Offering generated net cash proceeds of **$3.4 million**[38](index=38&type=chunk) - The May 2025 Public Offering triggered down-round features for Class C, D, and G Common Stock Warrants, resetting their exercise prices to **$3.30**[43](index=43&type=chunk) - A deemed dividend of approximately **$3.2 million** was recorded due to the price reset of the Class G Common Stock Warrants[43](index=43&type=chunk) [6. Preferred Stock](index=10&type=section&id=6.%20Preferred%20Stock) The company is authorized to issue up to **5,000,000** preferred shares, with none issued or outstanding as of June 30, 2025 - The Company is authorized to issue up to **5,000,000** shares of preferred stock[44](index=44&type=chunk) - As of June 30, 2025, there were no shares of preferred stock issued and outstanding[44](index=44&type=chunk) [7. Common Stock](index=12&type=section&id=7.%20Common%20Stock) Authorized for **500,000,000** common shares, **1,534,637** were outstanding as of June 30, 2025, with **6,798,719** reserved - The Company is authorized to issue up to **500,000,000** shares of common stock[45](index=45&type=chunk) | Metric | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Common stock issued and outstanding | 1,534,637 | 174,104 | | Total common stock reserved for issuance | 6,798,719 | 60,887 | - During the six months ended June 30, 2025, significant issuances included **127,669** shares from Class F warrant exercises, **19,529** shares for RSA grants, **225,000** shares from the May 2025 Public Offering, and **988,334** shares from pre-funded warrant exercises[48](index=48&type=chunk)[49](index=49&type=chunk) [8. Stock-Based Compensation](index=13&type=section&id=8.%20Stock-Based%20Compensation) The 2021 Equity Incentive Plan governs stock-based compensation, with **32,627** shares available and expense increasing to **$224,328** - The 2021 Equity Incentive Plan includes an evergreen provision, increasing available shares to **52,173** on January 1, 2025[51](index=51&type=chunk)[52](index=52&type=chunk) - As of June 30, 2025, **32,627** shares were available for future grants under the 2021 Plan[54](index=54&type=chunk) | Expense Category | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----------------------------------- | :------------------------------- | :------------------------------- | | General and administrative stock-based compensation expense | $189,930 | $59,197 | | Research and development stock-based compensation expense | $34,398 | $4,992 | | Total stock-based compensation expense | $224,328 | $64,189 | [9. Warrants](index=14&type=section&id=9.%20Warrants) Various common stock warrants are detailed, with the May 2025 offering triggering down-round provisions, resetting exercise prices to **$3.30** - Class C Common Stock Warrants are treated as a liability due to an alternative cashless exercise provision, with a fair value of **$786** as of June 30, 2025[60](index=60&type=chunk)[61](index=61&type=chunk) - The exercise price of Class D Common Stock Warrants was reset from **$48.00** to **$11.28** due to a reverse stock split, and further to **$3.30** due to a down-round provision triggered by the May 2025 Public Offering[62](index=62&type=chunk) - The May 2025 Public Offering triggered a down-round provision for Class G Common Stock Warrants, resetting the exercise price to **$3.30** and increasing underlying shares from **540,488** to **1,847,273**, resulting in a **$3.2 million** deemed dividend[68](index=68&type=chunk) - Class H Common Stock Warrants, issued in the May 2025 Public Offering, were valued at **$11.5 million** and allow purchase of up to **4,853,334** shares at an exercise price of **$3.30**[70](index=70&type=chunk) [10. Income Taxes](index=18&type=section&id=10.%20Income%20Taxes) No income tax provision or benefit was recorded due to recurring taxable losses and a full valuation allowance - No provision or benefit for income taxes was recorded for the three and six months ended June 30, 2025 and 2024[72](index=72&type=chunk) - A full valuation allowance was recorded against deferred tax assets due to recurring taxable losses[73](index=73&type=chunk) [11. Segment Information](index=19&type=section&id=11.%20Segment%20Information) Revelation Biosciences operates as a single reportable segment, with the CEO allocating resources based on consolidated net loss and total assets - The Company operates as one reportable segment, focused on developing therapeutics that modulate the innate immune system[76](index=76&type=chunk) - The Chief Executive Officer (CODM) assesses performance and allocates resources based on consolidated net loss and total assets[77](index=77&type=chunk) [12. Subsequent Events](index=19&type=section&id=12.%20Subsequent%20Events) Subsequent events include an increase in 2021 Equity Plan shares, a 1-for-3 reverse stock split, and **495,000** Class H Warrants cash-exercised - On July 1, 2025, the number of shares available under the 2021 Equity Plan increased to **830,073**[79](index=79&type=chunk) - The One Big Beautiful Bill Act (OBBBA) was enacted on July 4, 2025, with an expected immaterial impact on financial statements[80](index=80&type=chunk) - A **1-for-3** reverse stock split was effected on July 7, 2025, adjusting exercise prices of Class C, D, G, and H Warrants to **$2.20** and increasing Class G Warrants' underlying shares to **2,770,938**[81](index=81&type=chunk)[82](index=82&type=chunk) - During July 2025, **495,000** Class H Common Stock Warrants were cash-exercised, leading to the issuance of **165,000** shares for **$363,000**[83](index=83&type=chunk) [ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.](index=22&type=section&id=ITEM%202.%20MANAGEMENT%27S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS.) Management's discussion covers financial condition, operations, R&D focus, liquidity, capital resources, and going concern [Overview](index=22&type=section&id=Overview) - Revelation is a clinical-stage life science company developing Gemini-based therapies for GEM-AKI, GEM-CKD, GEM-PSI, and GEM-PBI[85](index=85&type=chunk) - The company has raised **$60.2 million** in net proceeds from capital stock sales since inception to June 30, 2025[87](index=87&type=chunk) - A net loss of **$4.5 million** for the six months ended June 30, 2025, and an accumulated deficit of **$45.0 million** as of June 30, 2025, raise substantial doubt about the company's ability to continue as a going concern[89](index=89&type=chunk) - The company expects to continue incurring operating losses and negative cash flows, requiring additional funding through equity or debt financings[89](index=89&type=chunk)[91](index=91&type=chunk) [Recent Developments](index=24&type=section&id=Recent%20Developments) - The One Big Beautiful Bill Act (OBBBA) was enacted on July 4, 2025, with its impact on consolidated financial statements expected to be immaterial[92](index=92&type=chunk) - The company effected a **1-for-16** reverse stock split on January 28, 2025, and a **1-for-3** reverse stock split on July 7, 2025[93](index=93&type=chunk) [Research and Development](index=24&type=section&id=Research%20and%20Development) - Research and development expenses primarily consist of external costs for clinical development, contract research organizations, manufacturing, regulatory submissions, laboratory supplies, and personnel costs[94](index=94&type=chunk) - All research and development expenses are expensed as incurred, with accruals adjusted as actual costs become known[95](index=95&type=chunk) - Research and development expenses are expected to increase substantially as product candidates advance into larger and later-stage clinical studies, with timing and costs being highly uncertain[96](index=96&type=chunk)[97](index=97&type=chunk) [General and Administrative](index=24&type=section&id=General%20and%20Administrative) - General and administrative expenses primarily include personnel costs, professional services (financial advisory, legal, audit, accounting), and consulting costs[98](index=98&type=chunk) - These expenses are expected to increase as the company expands its administrative function and incurs costs associated with operating as a public company[98](index=98&type=chunk) [Other (Expense) Income, Net](index=26&type=section&id=Other%20(Expense)%20Income,%20Net) - Other (expense) income, net, includes changes in fair value of warrant liability, clinical trial settlement expenses, foreign currency gains/losses, and interest income[99](index=99&type=chunk) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--------------------------------- | :------------------------------- | :------------------------------- | | Total other income (expense), net | $16,847 | $(5,867,422) | | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------------------- | :------------------------------- | :------------------------------- | | Total other income (expense), net | $60,749 | $(6,646,717) | [Results of Operations](index=27&type=section&id=Results%20of%20Operations) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Change ($) | Change (%) | | :--------------------------------- | :------------------------------- | :------------------------------- | :--------- | :--------- | | Research and development | $1,317,980 | $1,394,929 | $(76,949) | -5.5% | | General and administrative | $1,143,249 | $1,127,468 | $15,781 | +1.4% | | Net loss | $(2,444,382) | $(8,389,819) | $5,945,437 | -70.9% | | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change ($) | Change (%) | | :--------------------------------- | :------------------------------- | :------------------------------- | :--------- | :--------- | | Research and development | $2,176,810 | $2,112,511 | $64,299 | +3.0% | | General and administrative | $2,379,406 | $2,312,024 | $67,382 | +2.9% | | Total operating expenses | $4,556,216 | $4,424,535 | $131,681 | +3.0% | | Net loss | $(4,495,467) | $(11,071,252) | $6,575,785 | -59.4% | [Liquidity and Capital Resources](index=29&type=section&id=Liquidity%20and%20Capital%20Resources) - Since inception to June 30, 2025, the company has raised **$60.2 million** in net proceeds from capital stock sales[107](index=107&type=chunk) - As of June 30, 2025, the company had **$5.2 million** in cash and cash equivalents and an accumulated deficit of **$45.0 million**[107](index=107&type=chunk) - The current cash balance is not anticipated to be sufficient to sustain operations for one year, raising substantial doubt about the company's ability to continue as a going concern[111](index=111&type=chunk) - The company plans to seek additional funding through public or private equity or debt financings, acknowledging potential dilution or restrictive covenants[110](index=110&type=chunk)[112](index=112&type=chunk) [Cash Flows](index=30&type=section&id=Cash%20Flows) | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----------------------------------- | :------------------------------- | :------------------------------- | | Net cash used in operating activities | $(4,713,688) | $(5,316,651) | | Net cash used in investing activities | $0 | $(19,172) | | Net cash provided by financing activities | $3,388,541 | $5,417,180 | | Net (decrease) increase in cash and cash equivalents | $(1,325,147) | $81,357 | - Net cash used in operating activities decreased in H1 2025 primarily due to a lower net loss compared to H1 2024[115](index=115&type=chunk)[116](index=116&type=chunk) - Net cash provided by financing activities in H1 2025 was primarily from the May 2025 Public Offering[118](index=118&type=chunk) [Contractual Obligations and Other Commitments](index=30&type=section&id=Contractual%20Obligations%20and%20Other%20Commitments) - The company's contracts with third-party service providers and vendors are generally cancellable upon notice and are not considered material contractual obligations[119](index=119&type=chunk) [Off-Balance Sheet Arrangements](index=30&type=section&id=Off-Balance%20Sheet%20Arrangements) - As of June 30, 2025, the company did not have any off-balance sheet arrangements[120](index=120&type=chunk) [Quantitative and Qualitative Disclosure about Market Risk](index=30&type=section&id=Quantitative%20and%20Qualitative%20Disclosure%20about%20Market%20Risk) - The company is exposed to market risks in the ordinary course of its business[121](index=121&type=chunk) - As a smaller reporting company, the company is not required to provide detailed disclosures under this item[124](index=124&type=chunk) [Critical Accounting Policies and Significant Judgments and Estimates](index=30&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) - The preparation of financial statements in accordance with GAAP requires management to make estimates and assumptions that could materially differ from actual results[122](index=122&type=chunk) - Management regularly evaluates its estimates and assumptions using historical and industry experience[122](index=122&type=chunk) [Recent Accounting Pronouncements](index=31&type=section&id=Recent%20Accounting%20Pronouncements) - Refer to Note **2** of the unaudited condensed consolidated financial statements for information on recent accounting pronouncements[123](index=123&type=chunk) [ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.](index=31&type=section&id=ITEM%203.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISK.) As a smaller reporting company, Revelation Biosciences is exempt from detailed quantitative and qualitative market risk disclosures - The company is a smaller reporting company and is not required to provide detailed market risk disclosures[124](index=124&type=chunk) [ITEM 4. CONTROLS AND PROCEDURES.](index=31&type=section&id=ITEM%204.%20CONTROLS%20AND%20PROCEDURES.) Disclosure controls were effective as of June 30, 2025, with no material changes in internal control over financial reporting [Evaluation of Disclosure Controls and Procedures](index=31&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) - Management concluded that disclosure controls and procedures were effective at the reasonable assurance level as of June 30, 2025[125](index=125&type=chunk) - Disclosure controls are designed to ensure timely and accurate reporting of information required by the Exchange Act[125](index=125&type=chunk) [Changes in Internal Control over Financial Reporting](index=31&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) - There was no change in internal control over financial reporting during the most recent quarter that materially affected, or is reasonably likely to materially affect, internal control over financial reporting[126](index=126&type=chunk) PART II—OTHER INFORMATION [ITEM 1. LEGAL PROCEEDINGS.](index=31&type=section&id=ITEM%201.%20LEGAL%20PROCEEDINGS.) The company is not currently involved in any material legal proceedings or aware of any pending or threatened litigation - The Company is not a party to any material legal proceedings[128](index=128&type=chunk) [ITEM 1A. RISK FACTORS.](index=31&type=section&id=ITEM%201A.%20RISK%20FACTORS.) Key risks include potential delays in product approval due to FDA staffing and regulatory changes, and risks from increasing AI reliance [Significant reductions in FDA staffing and changes in federal regulatory policy may delay or adversely affect the approval and commercialization of our product candidates.](index=31&type=section&id=Significant%20reductions%20in%20FDA%20staffing%20and%20changes%20in%20federal%20regulatory%20policy%20may%20delay%20or%20adversely%20affect%20the%20approval%20and%20commercialization%20of%20our%20product%20candidates.) - Significant reductions in FDA workforce may lead to longer review times, missed milestones, and inconsistent feedback for new drugs and biologics[130](index=130&type=chunk) - These delays could adversely impact the company's ability to bring product candidates to market, disrupt development timelines, and increase costs[131](index=131&type=chunk) - Ongoing regulatory uncertainty may negatively affect investor confidence and the ability to raise additional capital, particularly for small and mid-cap biopharmaceutical companies[131](index=131&type=chunk) [Artificial intelligence is playing an increasingly important role in biotechnology which may have an effect on us.](index=33&type=section&id=Artificial%20intelligence%20is%20playing%20an%20increasingly%20important%20role%20in%20biotechnology%20which%20may%20have%20an%20effect%20on%20us.) - Artificial intelligence (AI) is increasingly used in biotechnology for target identification, drug discovery, preclinical modeling, and data analysis[133](index=133&type=chunk) - Risks associated with AI include potential failures to function as intended, produce accurate results, or comply with future regulatory guidelines[134](index=134&type=chunk)[135](index=135&type=chunk) - Reliance on third-party AI platforms and cloud infrastructure introduces risks of errors, outages, or security breaches[136](index=136&type=chunk) [ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.](index=33&type=section&id=ITEM%202.%20UNREGISTERED%20SALES%20OF%20EQUITY%20SECURITIES%20AND%20USE%20OF%20PROCEEDS.) This item is not applicable to Revelation Biosciences for the reporting period - This item is not applicable[138](index=138&type=chunk) [ITEM 3. DEFAULTS UPON SENIOR SECURITIES.](index=33&type=section&id=ITEM%203.%20DEFAULTS%20UPON%20SENIOR%20SECURITIES.) This item is not applicable to Revelation Biosciences for the reporting period - This item is not applicable[138](index=138&type=chunk) [ITEM 4. MINE SAFETY DISCLOSURES.](index=33&type=section&id=ITEM%204.%20MINE%20SAFETY%20DISCLOSURES.) This item is not applicable to Revelation Biosciences for the reporting period - This item is not applicable[139](index=139&type=chunk) [ITEM 5. OTHER INFORMATION.](index=33&type=section&id=ITEM%205.%20OTHER%20INFORMATION.) No other information is reported under this item for the reporting period - No other information is reported under this item[140](index=140&type=chunk) [ITEM 6. EXHIBITS, FINANCIAL STATEMENT SCHEDULES.](index=34&type=section&id=ITEM%206.%20EXHIBITS,%20FINANCIAL%20STATEMENT%20SCHEDULES.) This section lists all exhibits filed as part of this Quarterly Report, including corporate amendments, officer certifications, and XBRL - Exhibits include an Amendment to the Third Amended and Restated Certificate of Incorporation effective July 7, 2025[143](index=143&type=chunk) - Certifications of the Principal Executive Officer and Principal Financial Officer are filed pursuant to the Securities Exchange Act Rules[143](index=143&type=chunk) - XBRL Instance Document and Taxonomy Extension Documents are included for interactive data filing[143](index=143&type=chunk)