Press Release Introduction [Announcement of Q1 2024 Financial Results](index=1&type=section&id=Announcement%20of%20Q1%202024%20Financial%20Results) Revelation Biosciences, Inc. announced its financial results for the three months ended March 31, 2024, highlighting its status as a clinical-stage life sciences company focused on harnessing trained immunity for disease prevention and treatment - Revelation Biosciences, Inc. (NASDAQ: REVB) reported its financial results for the three months ended **March 31, 2024**[1](index=1&type=chunk) - The company is a **clinical-stage life sciences company** focused on harnessing trained immunity for disease prevention and treatment[1](index=1&type=chunk) [Company Overview](index=1&type=section&id=About%20Revelation%20Biosciences%2C%20Inc.) Revelation Biosciences is a clinical-stage life sciences company dedicated to leveraging trained immunity for disease prevention and treatment, primarily through its proprietary Gemini formulation, with multiple ongoing development programs - Revelation Biosciences, Inc. is a **clinical-stage life sciences company** focused on harnessing trained immunity for disease prevention and treatment[6](index=6&type=chunk) - The company utilizes its **proprietary formulation, Gemini**, in multiple ongoing programs[6](index=6&type=chunk) - Current programs for Gemini include prevention of **post-surgical infection**, **acute kidney injury**, and treatment of **chronic kidney disease**[6](index=6&type=chunk) [Product Overview: Gemini](index=1&type=section&id=About%20Gemini) Gemini, Revelation's proprietary PHAD® formulation, is being developed for systemic administration across multiple indications, including post-surgical infection, acute kidney injury, and chronic kidney disease, by modulating trained immunity - Gemini is a **proprietary formulation of phosphorylated hexaacyl disaccharide (PHAD®)** for systemic administration[5](index=5&type=chunk) - It is being developed for multiple indications, including pretreatment for **post-surgical infection (GEMINI-SSI)** and **acute kidney injury (GEMINI-AKI)**[5](index=5&type=chunk) - Gemini may also treat **chronic kidney disease (GEMINI-CKD)** by modulating trained immunity to attenuate the innate immune response[5](index=5&type=chunk) Financial Performance Summary [Key Financial Highlights](index=1&type=section&id=Key%20Financial%20Highlights) Revelation Biosciences reported an increase in cash and cash equivalents to $14.6 million as of March 31, 2024, which is projected to fund operations through 2024. The company recorded a net loss of $2.7 million for Q1 2024, a significant shift from net earnings in the prior year period Cash and Cash Equivalents (USD) | Metric | March 31, 2024 | December 31, 2023 | | :---------------------- | :------------- | :---------------- | | Cash and cash equivalents | $14.6 million | $12.0 million | - The increase in cash and cash equivalents was primarily due to **net cash received from financing activities**, offset by cash used for operating activities[2](index=2&type=chunk) - Revelation believes its current cash and cash equivalents are **sufficient to fund operations through 2024**[2](index=2&type=chunk) Net (Loss) Earnings and Per Share Data (USD) | Metric | Q1 2024 | Q1 2023 | | :------------------------- | :------------- | :------------ | | Net (loss) earnings | $(2.7) million | $6.2 million | | Basic net loss per share | $(2.46) | $45.52 | | Diluted net loss per share | $(2.46) | $37.07 | [Analysis of Operational Changes](index=1&type=section&id=Analysis%20of%20Operational%20Changes) The increase in net cash used for operating activities was primarily driven by higher clinical study expenses for GEM-AKI and GEM-SSI. The shift from net earnings to net loss was mainly due to the absence of a significant gain from the change in fair value of warrant liability, which occurred in the prior year Net Cash Used for Operating Activities (USD) | Metric | Q1 2024 | Q1 2023 | Change (YoY) | | :------------------------------ | :------------ | :------------ | :----------- | | Net cash used for operating activities | $2.8 million | $1.6 million | +$1.2 million| - The change in net cash used for operating activities was primarily due to **GEM-AKI and GEM-SSI clinical study expenses**[4](index=4&type=chunk) - The shift from net earnings in Q1 2023 to net loss in Q1 2024 was primarily due to a **$7.7 million gain from the change in fair value of warrant liability in Q1 2023**, which did not recur in Q1 2024[4](index=4&type=chunk) Consolidated Financial Statements [Consolidated Statements of Operations](index=3&type=section&id=Consolidated%20Statements%20of%20Operations) For the three months ended March 31, 2024, Revelation Biosciences reported a net loss of $2.68 million, a significant decline from net earnings of $6.16 million in the prior year. This was primarily due to a substantial decrease in other income related to warrant liability fair value changes, while total operating expenses increased by 17.4% year-over-year Consolidated Statements of Operations (USD) | Metric | 2024 | 2023 | Change (YoY) | | :-------------------------------- | :------------ | :------------ | :----------- | | Research and development | $717,582 | $525,273 | +36.6% | | General and administrative | $1,184,556 | $1,094,574 | +8.2% | | Total operating expenses | $1,902,138 | $1,619,847 | +17.4% | | Loss from operations | $(1,902,138) | $(1,619,847) | -17.4% | | Change in fair value of warrant liability | $68,427 | $7,744,935 | -99.1% | | Other (expense) income, net | $(847,722) | $34,107 | N/A | | Total other (expense) income, net | $(779,295) | $7,779,042 | N/A | | Net (loss) earnings | $(2,681,433) | $6,159,195 | N/A | | Net (loss) earnings per share, basic | $(2.46) | $45.52 | N/A | | Weighted-average shares, basic | 1,089,833 | 135,305 | +705.5% | | Net (loss) earnings per share, diluted | $(2.46) | $37.07 | N/A | | Weighted-average shares, diluted | 1,089,833 | 166,144 | +556.0% | [Consolidated Balance Sheets](index=4&type=section&id=Consolidated%20Balance%20Sheets) As of March 31, 2024, Revelation's total assets increased to $14.7 million from $12.2 million at December 31, 2023, primarily driven by a rise in cash and cash equivalents. Total liabilities saw a slight decrease, while stockholders' equity significantly increased due to additional paid-in capital Consolidated Balance Sheets (USD) | Metric | March 31, 2024 | December 31, 2023 | Change | | :-------------------------------- | :------------- | :---------------- | :----------- | | Cash and cash equivalents | $14,551,740 | $11,991,701 | +$2,560,039 | | Total current assets | $14,623,616 | $12,147,525 | +$2,476,091 | | Total assets | $14,701,610 | $12,212,609 | +$2,489,001 | | Total current liabilities | $5,228,465 | $5,564,894 | -$336,429 | | Total liabilities | $5,228,465 | $5,564,894 | -$336,429 | | Common Stock (shares outstanding) | 1,632,935 | 264,537 | +1,368,398 | | Additional paid-in-capital | $37,620,047 | $32,114,552 | +$5,505,495 | | Accumulated deficit | $(28,148,535) | $(25,467,102) | -$2,681,433 | | Total stockholders' equity | $9,473,145 | $6,647,715 | +$2,825,430 | Corporate Information [Forward-Looking Statements](index=1&type=section&id=Forward-Looking%20Statements) This section provides a standard disclaimer regarding forward-looking statements, cautioning investors about inherent risks and uncertainties that could cause actual results to differ materially from projections. Key risks include competition, ability to manage growth, successful product development, clinical study outcomes, regulatory approvals, and funding duration - The press release contains **forward-looking statements** as defined in the Private Securities Litigation Reform Act of 1995[9](index=9&type=chunk) - These statements involve known and unknown risks, uncertainties, and other factors that may cause **actual results to be materially different from anticipated**[9](index=9&type=chunk) - Key risks include the ability to meet financial goals, manage growth, successfully develop product candidates, complete clinical studies, obtain regulatory approvals, and the **expected duration of funding**[9](index=9&type=chunk) [Company Contacts](index=5&type=section&id=Company%20Contacts) Contact information for Revelation Biosciences' Vice President of Investor Relations & Human Resources and Chief Financial Officer is provided for investor and media inquiries - Contact information is provided for **Sandra Vedrick, Vice President, Investor Relations & Human Resources**, and **Chester Zygmont, III, Chief Financial Officer**[14](index=14&type=chunk)

Financial Performance - The company reported a net loss of $2.7 million for the three months ended March 31, 2024, compared to a net loss of $6.2 million for the same period in 2023, resulting in an accumulated deficit of $28.1 million as of March 31, 2024[117][135]. - Total operating expenses increased to $1.9 million for the three months ended March 31, 2024, from $1.6 million in the same period of 2023, reflecting a rise of $282,291[127]. - Research and development expenses rose to $717,582 for the three months ended March 31, 2024, up from $525,273 in 2023, primarily due to increased clinical study expenses related to GEM-AKI and GEM-SSI[128]. - General and administrative expenses increased to $1.2 million for the three months ended March 31, 2024, compared to $1.1 million in 2023, with personnel expenses accounting for a significant portion of the increase[129]. - For the three months ended March 31, 2024, net cash used in operating activities was $2.8 million, compared to $1.6 million for the same period in 2023, indicating an increase of 80% in cash outflow[139][140]. - Net cash provided by financing activities for the three months ended March 31, 2024, was $5.4 million, a decrease of 61% from $14.0 million in the same period in 2023[142]. - The company reported a net loss of $2.7 million for the three months ended March 31, 2024, compared to a net income of $6.2 million for the same period in 2023[139][140]. Liquidity and Funding - As of March 31, 2024, the company had available cash and cash equivalents of $14.6 million, which is insufficient to sustain operations for the next year, raising substantial doubt about its ability to continue as a going concern[115][135]. - The company plans to seek additional funding through public or private equity or debt financings, but there is no guarantee that financing will be obtained on acceptable terms[116]. - The company plans to seek additional funding through public or private equity or debt financings to continue as a going concern[136]. Operational Outlook - The company has never generated revenue and does not expect to do so until it successfully completes development and obtains regulatory approval for its product candidates, which is anticipated to take several years[119][135]. - The company expects to continue incurring significant operating losses and negative cash flows as it expands its research and development activities[133]. Stock and Obligations - A reverse stock split of 1-for-30 was executed on January 25, 2024, following approval at a special meeting of stockholders[120]. - As of March 31, 2024, the company had total contractual obligations of $42,800, all related to operating lease obligations[143]. - There were 94 unvested and unissued Rollover RSU awards and 1,157 stock options outstanding as of March 31, 2024[152]. Other Considerations - The company has not experienced significant changes in its estimates of clinical study accruals to date[150]. - The fair value of cash and cash equivalents would not be significantly affected by interest rate changes due to their short-term nature[147]. - The company is exposed to foreign currency transaction gains or losses, but these have not been material to date[148]. - The company has elected to use an extended transition period under the JOBS Act to comply with new or revised accounting standards[156].

Financial Position - As of December 31, 2023, Revelation had $12.0 million in cash and cash equivalents, an increase from $5.3 million as of December 31, 2022, primarily due to net cash received from financing activities [2]. - Revelation's total assets as of December 31, 2023, were $12.2 million, up from $5.5 million as of December 31, 2022 [14]. - Revelation's accumulated deficit as of December 31, 2023, was $25.5 million, compared to $25.3 million as of December 31, 2022 [14]. - The company anticipates that its current cash and cash equivalents will be sufficient to fund operations through 2024 [2]. Operating Performance - Net cash used for operating activities for the three months ended December 31, 2023, was $2.0 million, compared to $0.9 million for the same period in 2022, while for the twelve months, it was $7.3 million compared to $11.2 million in 2022 [3]. - The net loss for the three months ended December 31, 2023, was $2.2 million, or $8.33 per share, compared to a net loss of $1.2 million, or $15.61 per share, for the same period in 2022 [3]. - The total operating expenses for the three months ended December 31, 2023, were $2.3 million, compared to $1.2 million for the same period in 2022 [12]. Financing Activities - Revelation completed a $6.2 million public offering and commenced its first Phase 1 clinical study of Gemini in March 2024 [6]. - The change in fair value of the warrant liability resulted in an $8.3 million gain for the twelve months ended December 31, 2023 [5]. Product Development - The company is advancing the evaluation of its proprietary formulation, Gemini, which is being developed for multiple indications including acute kidney injury and post-surgical infection [7].

Financial Condition - As of December 31, 2023, the company had an accumulated deficit of $25.5 million, indicating ongoing financial challenges [205]. - The company has incurred net losses since inception and does not anticipate generating revenue from product sales in the next couple of years [209]. - The company received approximately $5.4 million in net proceeds from a public offering completed in February 2024, but this may not be sufficient to sustain operations for the next year [206]. - The company expects to incur substantial and increasing operating losses over the next several years as research and development activities expand [205]. - The company may not be able to raise additional funding on acceptable terms, which could negatively impact its operations and product development efforts [210]. - Unfavorable global economic conditions could adversely affect the company's business, financial condition, and results of operations [215]. Product Development and Regulatory Approval - The company has no products approved for marketing and is in the early stages of development for its Program Products, which include GEM-SSI, GEM-AKI, and GEM-CKD [209]. - Regulatory approval for Program Products is uncertain, and even if obtained, it may come with limitations on indicated uses or patient populations [232]. - The company may not have sufficient financial resources to complete necessary clinical studies for Program Products, which could hinder regulatory approval [236]. - The FDA and other regulatory authorities' ability to review and approve new products can be affected by various factors, including funding shortages and global health concerns [237]. - The occurrence of adverse events or regulatory issues could inhibit the company's ability to commercialize products and generate revenue [242]. - The company may face significant delays in clinical studies due to various factors, which could harm the commercial prospects of its Program Products [219]. - The company may face difficulties in enrolling patients for clinical studies, which could delay or prevent the progression of these studies [225]. - Insufficient patient enrollment could lead to significant delays or abandonment of clinical studies, adversely affecting the ability to seek marketing approval for Program Products [227]. Clinical Studies and Third-Party Reliance - The company has limited experience in conducting clinical studies and has not yet conducted pivotal clinical studies necessary for regulatory approval [224]. - The company relies on third parties for certain elements of its preclinical and clinical studies, and any failure on their part could hinder regulatory approval [224]. - The company relies on third parties for clinical studies and manufacturing, which could lead to delays if these parties do not meet their contractual obligations [251]. - The company may struggle to maintain necessary third-party relationships for the development and commercialization of its product candidates [262]. - The company expects to expend substantial management time and resources to establish and manage relationships with third parties, which may involve significant payments [264]. Intellectual Property and Competition - The company’s ability to compete effectively depends on obtaining and maintaining effective patent rights for its product candidates [271]. - The patent prosecution process is expensive and time-consuming, and the company may not be able to secure necessary patent protections [277]. - The company may not be able to protect its intellectual property rights globally, leading to potential competition from third parties in jurisdictions without patent protection [279]. - The company relies on trade secret protection and confidentiality agreements, but these can be difficult to enforce, posing risks to proprietary information [285]. - The pharmaceutical industry is highly competitive, with competitors potentially developing more effective or cheaper products, which could adversely affect the company's financial condition [246]. - Competitors may have greater resources, including financial and marketing capabilities, which could impact the company's market acceptance [247]. Operational Challenges and Growth - The company currently has 10 employees as of March 18, 2024, and anticipates needing to expand its workforce to support product development [304]. - The company may face challenges in managing growth and operational improvements, which could disrupt its business strategies [306]. - The company faces challenges in identifying, discovering, or licensing additional product candidates, which are critical for its business success [309]. - Development efforts for unsuccessful programs may need to be abandoned, potentially leading to a material adverse effect on the company's operations [310]. Compliance and Legal Risks - Compliance with healthcare laws and regulations is essential, as violations could result in substantial penalties and reputational harm [337]. - The company must navigate complex data protection regulations, particularly in the EEA, which could increase compliance costs and risks of noncompliance [340]. - Failure to comply with GDPR and related laws may lead to substantial fines and civil claims, adversely affecting the company's financial condition [343]. - The company is currently involved in litigation with LifeSci Capital LLC, claiming damages of $5.3 million, which could adversely affect its financial condition if unsuccessful [372]. - Misconduct by employees or partners could expose the company to regulatory sanctions and significant fines, impacting its business operations [335]. Market and Financial Risks - The company currently has no approved Program Products and lacks a marketing and sales organization, which could hinder revenue generation [326]. - Market acceptance and reimbursement for Program Products are uncertain, which could affect profitability if coverage is limited by payors [328]. - Obtaining coverage and reimbursement approval for products is a time-consuming and costly process, with uncertainty regarding the availability of adequate reimbursement impacting commercialization [329]. - The company faces significant risks related to clinical study and product liability, which could materially affect its financial condition and operational results [330]. - Current insurance coverage may not adequately protect against potential liabilities, and obtaining sufficient product liability insurance could be challenging and costly [334]. - The company does not anticipate paying cash dividends in the foreseeable future, which may limit investor appeal [357]. Corporate Governance and Compliance Costs - Maintaining effective internal control over financial reporting is crucial; failure to do so could harm investor confidence and stock value [358]. - As an emerging growth company, reduced reporting requirements may make the company's stock less attractive to investors, potentially affecting market activity [359]. - Compliance with corporate governance laws and financial reporting standards has increased legal and financial compliance costs, impacting operational efficiency [363]. - The company is subject to anti-takeover provisions that may impair unsolicited takeover attempts, potentially affecting shareholder interests [364]. - Revelation's common stock is listed on the Nasdaq Capital Market, and failure to meet listing standards could result in delisting, adversely affecting stockholder value [367].

As filed with the U.S. Securities and Exchange Commission on January 30, 2024. Registration No. 333-276232 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 __________________________________________ Amendment No. 2 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 4660 La Jolla Village Drive, Suite 100, San Diego, CA 92122 __________________________________________ REVELATION BIOSCIENCES, INC. (Exact name of registrant as specified in its charter) ___________________ ...

As filed with the U.S. Securities and Exchange Commission on January 29, 2024. Registration No. 333-276232 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 __________________________________________ (Jurisdiction of incorporation or organization) Amendment No. 1 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 __________________________________________ REVELATION BIOSCIENCES, INC. (Primary Standard Industrial Classification Code Number) (Exact name of registrant as ...

As filed with the U.S. Securities and Exchange Commission on December 22, 2023. Registration No. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 __________________________________________ FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 __________________________________________ REVELATION BIOSCIENCES, INC. (Exact name of registrant as specified in its charter) __________________________________________ DELAWARE (Jurisdiction of incorporation or organization) 2834 84- ...

Financial Performance - As of September 30, 2023, the company had an accumulated deficit of $23.3 million and expects to continue generating operating losses and negative cash flows for the foreseeable future[138]. - The company reported a net loss of $2.63 million for the three months ended September 30, 2023, compared to a net loss of $1.17 million for the same period in 2022[148]. - The company expects to continue to incur significant operating and net losses, as well as negative cash flows from operations, for the foreseeable future[160]. - Net cash used in operating activities was $5.3 million for the nine months ended September 30, 2023, compared to $10.3 million in 2022[163]. Funding and Capital Structure - The company raised net proceeds of $43.9 million through the issuance and sale of capital stock since its inception in May 2020, but current cash and cash equivalents will not be sufficient to sustain operations within one year[136]. - The company plans to seek additional funding through public or private equity or debt financings, but there is no guarantee that financing will be obtained on acceptable terms[137]. - A reverse stock split of 1-for-35 was executed on February 1, 2023, increasing the authorized common stock from 100 million to 500 million shares[141]. - Net cash provided by financing activities was $14.0 million for the nine months ended September 30, 2023, from net cash proceeds of $14.0 million received from the February 2023 Public Offering[166]. Expenses - Research and development expenses for the three months ended September 30, 2023, were $1.65 million, compared to $1.27 million for the same period in 2022, reflecting an increase of approximately 30%[148]. - General and administrative expenses for the three months ended September 30, 2023, were $1.13 million, compared to $0.82 million for the same period in 2022, indicating a rise of approximately 38%[148]. - Total operating expenses for the nine months ended September 30, 2023, were $6.33 million, down from $9.65 million for the same period in 2022, a decrease of approximately 34%[148]. - Research and development expenses increased by $1.3 million, from $0.4 million for the three months ended September 30, 2022 to $1.7 million for the three months ended September 30, 2023[150]. - For the nine months ended September 30, 2023, research and development expenses decreased by $2.0 million, from $5.0 million in 2022 to $3.1 million in 2023[151]. - General and administrative expenses increased by $0.3 million, from $0.8 million for the three months ended September 30, 2022 to $1.1 million for the three months ended September 30, 2023[152]. - General and administrative expenses decreased by $1.4 million, from $4.6 million for the nine months ended September 30, 2022 to $3.2 million for the nine months ended September 30, 2023[153]. Cash and Liquidity - As of September 30, 2023, the company had available cash and cash equivalents of $14.0 million and an accumulated deficit of $23.3 million[156]. - The company anticipates that research and development expenses will increase substantially as it continues to develop its product candidates[144]. Accounting and Compliance - The company is classified as an "emerging growth company" under the JOBS Act, allowing it to delay adopting new accounting standards[181]. - The company has elected to use an extended transition period for compliance with new accounting standards until it is no longer classified as an emerging growth company[182]. - Stock-based compensation expenses are recognized based on the estimated fair value of awards at the date of grant[177]. Other Financial Information - Other income (expense), net was $149,521 for the three months ended September 30, 2023, compared to $28,728 in 2022[154]. - The fair value of cash and cash equivalents would not be significantly affected by interest rate changes due to their short-term nature[172]. - A 10% increase or decrease in currency exchange rates would not have a material effect on financial results[173]. - Foreign currency transaction gains and losses have not been material to date, and the company may consider a formal hedging program in the future[173]. - Management's estimates for accrued expenses related to clinical studies are based on patient enrollment levels and may differ from actual expenses[176]. - The company has not experienced significant changes in estimates of clinical study accruals to date[176]. - The fair value of common stock is determined based on various factors including market conditions and comparable public companies[179]. - The company has entered into an operating lease for laboratory space with total contractual obligations of $28,890[168]. - As of September 30, 2023, there were 3,006 Rollover RSU awards and 35,005 stock options outstanding[178].

Financial Condition - As of June 30, 2023, the company had an accumulated deficit of $20.6 million and expects to continue generating operating losses and negative cash flows for the foreseeable future[140]. - The company raised net proceeds of $43.9 million through the issuance and sale of capital stock since its inception in May 2020, but current cash and cash equivalents will not be sufficient for necessary product development or commercialization efforts[138]. - As of June 30, 2023, there were 3,006 Rollover RSU awards and 35,005 stock options outstanding, indicating ongoing stock-based compensation commitments[180]. - As of June 30, 2023, there were 3,006 Rollover RSU awards and 35,005 stock options outstanding[180]. - The company has entered into an operating lease for laboratory space with total contractual obligations of $57,780[170]. - As of June 30, 2023, the company had available cash and cash equivalents of $15.7 million and an accumulated deficit of $20.6 million[158]. - The company expects to continue to incur significant operating losses and negative cash flows for the foreseeable future[162]. Research and Development - Research and development expenses for the three months ended June 30, 2023, were $1.4 million, a decrease of $0.1 million from $1.0 million in the same period in 2022[151]. - For the six months ended June 30, 2023, research and development expenses decreased by $3.2 million to $1.4 million from $4.7 million in the same period in 2022[152]. - The company anticipates that research and development expenses will increase substantially as it continues to advance its product candidates into larger clinical studies[146]. - The company has never generated revenue and does not expect to do so until successful completion and regulatory approval of its product candidates, which may take several years[141]. - The company is focused on developing therapeutics for acute organ injury and chronic organ disease, with several product candidates in various stages of development[136]. Operating Expenses - Total operating expenses for the three months ended June 30, 2023, were $1.9 million, compared to $1.9 million for the same period in 2022, reflecting a slight increase[150]. - General and administrative expenses increased by $0.1 million, from $0.9 million for the three months ended June 30, 2022 to $1.0 million for the three months ended June 30, 2023[154]. - General and administrative expenses decreased by $1.7 million, from $3.8 million for the six months ended June 30, 2022 to $2.1 million for the six months ended June 30, 2023[155]. Funding and Going Concern - The company plans to seek additional funding through public or private equity or debt financings, but there is substantial doubt about its ability to continue as a going concern if funding is not obtained[139]. - The company plans to seek additional funding through public or private equity or debt financings to continue operations[163]. Stock and Market Risks - A reverse stock split of 1-for-35 was executed on February 1, 2023, following the approval to change the authorized common stock from 100 million to 500 million shares[142]. - The fair value of common stock is determined based on various factors including third-party valuations, operating results, and market conditions, particularly after the Business Combination[181]. - The company is classified as an "emerging growth company" under the JOBS Act, allowing it to delay the adoption of new accounting standards until they apply to private companies[183]. - The company has opted to use an extended transition period for compliance with new accounting standards, which may affect comparability with other public companies[184]. - The company is exposed to market risks in the ordinary course of business, which may affect its financial condition and results of operations[173]. Cash Flow - Net cash used in operating activities was $3.6 million for the six months ended June 30, 2023, compared to $8.5 million for the same period in 2022[165]. - Net cash provided by financing activities was $14.0 million during the six months ended June 30, 2023, primarily from a public offering[168]. Other Financial Information - Other income (expense), net was $484,860 for the three months ended June 30, 2023, related to the change in fair value of the warrant liability and foreign currency transaction gains[156]. - Foreign currency transaction gains and losses have not been material to date, with a 10% change in exchange rates expected to have no significant impact on financial results[175]. - Cash and cash equivalents are primarily in highly liquid investments with short maturities, minimizing interest rate risk exposure[174]. - The company recognizes stock-based compensation expenses based on the estimated fair value of awards at the grant date, using the Black-Scholes option-pricing model[179]. - Management's estimates and assumptions in financial reporting are based on industry experience, but actual results may differ materially from these estimates[176]. - The company has not experienced significant changes in estimates of clinical study accruals, indicating stable management of research and development expenditures[178].

[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section provides the unaudited condensed consolidated financial statements, management's discussion and analysis, market risk disclosures, and controls and procedures for the quarter ended March 31, 2023 [Condensed Consolidated Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) This section presents the unaudited financial statements for Q1 2023, highlighting a shift to net income, increased cash from a public offering, and ongoing going concern doubts [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet shows a significant increase in cash and total assets, primarily driven by financing activities and a rise in stockholders' equity | | March 31, 2023 ($) | December 31, 2022 ($) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | 17,702,818 | 5,252,979 | | Total current assets | 18,035,205 | 5,413,282 | | Total assets | 18,119,075 | 5,503,415 | | **Liabilities & Equity** | | | | Warrant Liability | 3,511,155 | 0 | | Total current liabilities | 8,101,429 | 4,450,962 | | Total stockholders' equity | 10,017,646 | 1,052,453 | [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company reported a net income of $6.16 million in Q1 2023, a significant turnaround driven by a warrant liability gain and reduced operating expenses | Metric | Q1 2023 ($) | Q1 2022 ($) | | :--- | :--- | :--- | | Research and development | 525,273 | 3,680,280 | | General and administrative | 1,094,574 | 2,906,020 | | Loss from operations | (1,619,847) | (6,586,300) | | Change in fair value of warrant liability | 7,744,935 | 0 | | **Net income (loss)** | **6,159,195** | **(6,616,541)** | | Net earnings (loss) per share, basic | 2.79 | (15.90) | [Condensed Consolidated Statements of Changes in Stockholders' Equity (Deficit)](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity%20(Deficit)) Stockholders' equity significantly increased due to net income and equity issuances from the February 2023 Public Offering and warrant exercises - Key activities impacting stockholders' equity in Q1 2023 included the February 2023 Public Offering, exercise of Class C Pre-Funded and Common Stock Warrants, stock-based compensation expense, and the net income of **$6.16 million**[15](index=15&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash flows show improved operating cash usage and a significant increase in cash from financing activities, primarily a $14.0 million public offering | Cash Flow Activity | Q1 2023 ($) | Q1 2022 ($) | | :--- | :--- | :--- | | Net cash used in operating activities | (1,575,154) | (4,830,066) | | Net cash provided by financing activities | 14,024,993 | 10,741,598 | | **Net increase in cash and cash equivalents** | **12,449,839** | **5,911,532** | | Cash and cash equivalents at end of period | 17,702,818 | 7,186,261 | - The company received net proceeds of **$14,029,974** from its February 2023 Public Offering[18](index=18&type=chunk) [Notes to the Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements) Key notes include a reverse stock split, a $14.0 million public offering, ongoing going concern doubts, and details on significant legal disputes - The company executed a **1-for-35 reverse stock split** on February 1, 2023, and increased its authorized common stock from 100 million to 500 million shares[25](index=25&type=chunk)[88](index=88&type=chunk) - Management has **substantial doubt** about the company's ability to continue as a going concern, as current cash is not expected to sustain operations for one year from the financial statement issuance date[27](index=27&type=chunk) - The company is involved in legal proceedings with LifeSci Capital LLC for approximately **$5.3 million** in disputed fees and with A-IR Clinical Research Ltd. for **£1.6 million** in disputed invoices[63](index=63&type=chunk)[65](index=65&type=chunk) - The Class C Common Stock Warrants issued in the February 2023 offering are accounted for as a liability, and the change in their fair value resulted in a **$7.7 million gain** recognized in the statement of operations[123](index=123&type=chunk)[126](index=126&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial performance, liquidity, and operational focus, highlighting reduced operating expenses, a $14.0 million capital raise, and persistent going concern doubts - The company is a clinical-stage biopharmaceutical firm focused on developing therapeutics and diagnostics for the innate immune system and has not yet generated any revenue[132](index=132&type=chunk)[137](index=137&type=chunk) - Management has **substantial doubt** about the company's ability to continue as a going concern, as current cash is not anticipated to be sufficient to sustain operations for one year[134](index=134&type=chunk)[154](index=154&type=chunk) Operating Expenses | Expense Category | Q1 2023 ($) | Q1 2022 ($) | Change ($) | | :--- | :--- | :--- | :--- | | Research and development | 525,273 | 3,680,280 | (3,155,007) | | General and administrative | 1,094,574 | 2,906,020 | (1,811,446) | | **Total operating expenses** | **1,619,847** | **6,586,300** | **(4,966,453)** | - The decrease in R&D expenses was primarily due to a **$2.8 million reduction** in clinical study expenses for REVTx-99a. The decrease in G&A expenses was mainly due to lower financial advisory, legal, and D&O insurance costs[147](index=147&type=chunk)[148](index=148&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=28&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, detailed market risk disclosures are not required, with interest rate and foreign currency risks deemed immaterial - The company is a smaller reporting company and is not required to provide the information otherwise required under this item[178](index=178&type=chunk) - The company's exposure to interest rate risk and foreign currency risk is not considered material. A **10% change** in currency exchange rates would not have a material effect on financial results[167](index=167&type=chunk)[168](index=168&type=chunk) [Controls and Procedures](index=29&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective, with no material changes to internal control over financial reporting during the quarter - Management concluded that the company's disclosure controls and procedures were effective as of March 31, 2023[179](index=179&type=chunk) - There were no changes in internal control over financial reporting during the quarter that materially affected, or are reasonably likely to materially affect, internal controls[180](index=180&type=chunk) [PART II. OTHER INFORMATION](index=30&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section covers legal proceedings, risk factors, equity sales, defaults, mine safety, and other disclosures [Legal Proceedings](index=30&type=section&id=Item%201.%20Legal%20Proceedings) The company is involved in two significant legal disputes concerning disputed fees and invoices, with outcomes currently indeterminable - LifeSci Capital LLC filed an action seeking damages of approximately **$2.7 million in cash** and **$2.6 million in equity** for unpaid banking and advisory fees. The company is disputing the amount[183](index=183&type=chunk) - A-IR Clinical Research Ltd. filed a claim for **£1.6 million** in unpaid invoices related to a viral challenge study, which the company is disputing on the basis of non-performance and misrepresentation[185](index=185&type=chunk) [Risk Factors](index=30&type=section&id=Item%201A.%20Risk%20Factors) No material changes have occurred regarding the risk factors previously disclosed in the company's Annual Report on Form 10-K - There have been no material changes from the risk factors disclosed in the company's Annual Report on Form 10-K for the year ended December 31, 2022[186](index=186&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=30&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities or use of proceeds were reported during the period - This item is not applicable for the reporting period[187](index=187&type=chunk)[190](index=190&type=chunk) [Defaults Upon Senior Securities](index=30&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) No defaults upon senior securities were reported during the period - This item is not applicable for the reporting period[187](index=187&type=chunk) [Mine Safety Disclosures](index=30&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section is not applicable as the company is not involved in mining operations - This item is not applicable[188](index=188&type=chunk) [Other Information](index=30&type=section&id=Item%205.%20Other%20Information) No other information was reported for the period - There is no other information to report[189](index=189&type=chunk) [Exhibits](index=31&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including officer certifications and XBRL financial data - The exhibits filed with this report include CEO and CFO certifications pursuant to Sarbanes-Oxley Act rules and XBRL interactive data files[192](index=192&type=chunk)