Revelation Biosciences(REVB) - 2024 Q4 - Annual Report

Part I ITEM 1. BUSINESS. Revelation Biosciences is a clinical-stage life science company focused on rebalancing inflammation using its proprietary Gemini formulation, developing programs for acute kidney injury, chronic kidney disease, and post-surgical infection - Revelation Biosciences is a clinical-stage life science company focused on rebalancing inflammation using its proprietary Gemini formulation (PHAD, a TLR4 agonist)[23][29][30] - The company's primary programs include GEM-AKI (prevention of acute kidney injury), GEM-CKD (treatment of chronic kidney disease), and GEM-PSI (prevention of post-surgical infection)[23][29] - Revelation effected reverse stock splits in 2025 (1-for-16), 2024 (1-for-30), and 2023 (1-for-35) to manage its outstanding shares[8][25][26][27] - The company relies on third parties for manufacturing raw materials (PHAD has a single supplier, Avanti Polar Lipids, Inc.) and conducting preclinical and clinical studies[17][88] - Revelation holds an exclusive worldwide license agreement with Vanderbilt University for the development and commercialization of PHAD for treating or preventing infections[90] Overview Revelation Biosciences is a clinical-stage life science company developing therapies based on its proprietary Gemini formulation to rebalance inflammation, with main programs targeting acute kidney injury, chronic kidney disease, and post-surgical infection - Revelation is a clinical-stage life science company focused on rebalancing inflammation using its proprietary Gemini formulation[23] - Current programs include GEM-AKI (prevention of AKI), GEM-CKD (treatment of CKD), and GEM-PSI (prevention of PSI)[23] - The company's common stock and warrants are listed on The Nasdaq Stock Market, LLC under ticker symbols "REVB" and "REVBW" respectively[24] Recent Developments Revelation Biosciences has undertaken several reverse stock splits in recent years, including a 1-for-16 split in January 2025, a 1-for-30 split in January 2024, and a 1-for-35 split in February 2023, to adjust its outstanding shares - On January 28, 2025, the company effected a 1-for-16 reverse stock split[25] - On January 25, 2024, a 1-for-30 reverse stock split was effected[26] - On February 1, 2023, a 1-for-35 reverse stock split was effected, alongside an increase in authorized common stock to 500,000,000 shares[27] Business Strategy and Pipeline Revelation is developing a pipeline of high-value products based on its proprietary Gemini formulation, a Toll-like receptor 4 (TLR4) agonist, targeting acute kidney injury, chronic kidney disease, and post-surgical infection - Revelation is developing a pipeline of high-value products based on Gemini, its proprietary formulation of phosphorylated hexaacyl disaccharide (PHAD®), a TLR4 agonist[29][30] Revelation Biosciences Pipeline | Program | Therapeutic Indication | | :------ | :--------------------- | | GEM-AKI | Acute Kidney Injury | | GEM-CKD | Chronic Kidney Disease | | GEM-PSI | Post Surgical Infection | The Gemini Platform The Gemini platform utilizes PHAD®, a synthetic version of MPLA, to stimulate TLR4, leading to a controlled immune response that helps resist infection and reduce inflammation - Gemini is a proprietary formulation of PHAD®, a synthetic version of MPLA, that stimulates Toll-like receptor 4 (TLR4)[30] - TLR4 stimulation by Gemini modulates innate and adaptive immune responses, leading to controlled cytokine and chemokine production, which can stimulate infection-fighting cells, reduce inflammation, and regulate immune activity[30] Gemini-AKI Program The Gemini-AKI program aims to prevent acute kidney injury by immunologic preconditioning, with preclinical studies showing reduced severity and a Phase 1b study in CKD patients starting in January 2025 - Gemini-AKI is being developed for the prevention of AKI due to external stress or insult[31] - Preclinical studies demonstrated that preconditioning with PHAD significantly reduces the severity and duration of AKI[32] - A Phase 1 clinical study in 2024 showed a significant increase in anti-inflammatory cytokines (IL-1RA and IL-10), and a Phase 1b clinical study in CKD patients started in January 2025, with data expected in the first half of the year[33] Gemini-CKD Program The Gemini-CKD program focuses on preventing chronic kidney disease progression by modulating the immune response, with preclinical studies showing reduced scar tissue and a Phase 1b study in CKD patients starting in January 2025 - Gemini-CKD is being developed as a potential therapy for preventing the progression of CKD by modulating the immune response from pro-inflammatory to anti-inflammatory[34] - Preclinical studies showed Gemini significantly reduces scar tissue formation in a hyperinflammatory kidney injury model[35] - A Phase 1b clinical study in CKD patients started in January 2025, with data expected in the first half of the year[35] Gemini-PSI Program The Gemini-PSI program, licensed from Vanderbilt University, aims to prevent or treat surgical site infections by priming the immune system, with preclinical studies showing augmented immune response and a Phase 1 study completed in 2024 - Gemini-PSI is being developed for the prevention or treatment of surgical site infection through a license agreement with Vanderbilt University[36] - Preclinical studies showed systemic pretreatment with PHAD significantly augmented immune response, reducing infection duration and severity[37] - A Phase 1 clinical study in 2024 showed a significant increase in anti-inflammatory cytokines, and next development steps are being evaluated[82] Our Strategy Revelation's strategy is to become a leading biopharmaceutical company by developing immune-modulating therapeutics for acute kidney injury, chronic kidney disease, and post-surgical infection - The company's goal is to become a leading biopharmaceutical company focused on developing immune-modulating therapeutics[38] - Key strategic components include advancing the development of Gemini for AKI prevention, CKD treatment, and PSI prevention/treatment[44] Our Corporate History and Team Revelation Biosciences was incorporated in Delaware in November 2019 and is based in San Diego, California, with a management team experienced in drug development and commercialization - The Company was incorporated in Delaware on November 20, 2019, and is based in San Diego, California[38] - Revelation has a management team of biopharmaceutical experts with extensive experience in drug development, manufacturing, and commercialization[38] BACKGROUND This section provides an overview of Acute Kidney Injury, Chronic Kidney Disease, and Post Surgical Infection, highlighting their significant health burden and unmet therapeutic needs - Acute Kidney Injury (AKI) is a rapid loss of kidney function, a significant health problem with no approved preventive or therapeutic treatments, requiring intensive supportive care[39][40][44][51] - Chronic Kidney Disease (CKD) affects approximately 15% of US adults (37 million people) and can progress to end-stage renal disease, with a significant unmet need for therapies despite Farxiga's approval for progression[45][46][49][52][54] - Post Surgical Infection (PSI) is a common healthcare-associated infection, with approximately 687,000 cases and 72,000 deaths in acute care settings in 2015, and no approved therapies for prevention outside of antibiotics, raising concerns about antibiotic resistance[50][55][56] REVELATION'S PROGRAMS Revelation's programs leverage the Gemini platform to modulate the innate immune system, with preclinical studies showing promising results for AKI, CKD, and PSI, and clinical development progressing with Phase 1 and 1b studies - The Gemini platform, based on PHAD®, stimulates the innate immune response via TLR4 to modulate inflammation and enhance resistance to stress, infection, and acute/chronic disorders[57][58][59] - Preclinical studies for GEM-AKI demonstrated significantly decreased severity and duration of acute kidney injury due to ischemia[61][62][64][66][67] - Preclinical studies for GEM-CKD showed Gemini significantly reduced fibrosis in a hyperinflammatory kidney injury model, mediated by validated target cytokines like TGF-β (reduced) and IL-10/NGAL (increased)[71][73][75] - Preclinical studies for Gemini-PSI indicated that PHAD pretreatment provided protection against both gram-negative and gram-positive bacterial infections by augmenting the immune response[77][78][80][81] - Phase 1 clinical studies for GEM-AKI and GEM-PSI in 2024 showed a significant increase in anti-inflammatory cytokines, and Phase 1b studies for GEM-AKI and GEM-CKD in CKD patients began in January 2025, with data expected in the first half of the year[33][35][68][76][82] Competition The biopharmaceutical industry is highly competitive, with Revelation facing competition from larger, better-resourced companies that may develop more effective or cheaper products - The biopharmaceutical industry is intensely competitive and subject to rapid technological advancements[83][217] - Revelation faces competition from large pharmaceutical companies, biotechnology companies, universities, and research institutions, many of which have substantially greater resources and experience[83][87][218][219] - Competitors may develop products that are more effective, safer, cheaper, or reach the market sooner, potentially adversely affecting Revelation's financial condition and ability to commercialize its Program Products[87][219] Manufacturing and Supply Revelation relies entirely on third parties for manufacturing its Program Products, with a single supplier for the key raw material PHAD® and no long-term supply agreement, posing significant risk - Revelation does not own or operate manufacturing facilities and relies on third parties for the manufacturing of its Program Products for all stages of development and potential commercialization[88] - There is only one supplier for PHAD®, Avanti Polar Lipids, Inc., and Revelation does not have a long-term supply agreement with them, creating a potential supply risk[88] Strategic Acquisitions and In-Licensing Revelation actively seeks to expand its pipeline through internal development, acquisitions, strategic partnerships, and in-licensing of new therapeutic product candidates - Revelation aims to deepen its pipeline through internal organic development and portfolio additions via acquisitions, strategic partnerships, and in-licensing of new therapeutic product candidates[89] License Revelation holds an exclusive worldwide license agreement with Vanderbilt University for developing and commercializing PHAD for infections, with obligations for development, financing, and royalty payments - Revelation holds an exclusive worldwide license agreement with Vanderbilt University, effective September 29, 2022, to develop and commercialize PHAD for treating or preventing infections[90] - The license requires Revelation to use commercially reasonable efforts to develop and commercialize licensed products, achieve specific financing, development, regulatory, and clinical milestone events, and file an IND by the end of 2032[91] - Revelation is obligated to make milestone payments and royalties on sales, and Vanderbilt can terminate the agreement if development milestones are not met[92] Sales and Marketing Revelation currently lacks marketing, sales, or distribution capabilities and plans to either build its own sales force for niche markets or seek third-party support for broader commercialization - Revelation currently has no marketing, sales, or distribution capabilities[93] - The company plans to either establish its own sales force for limited geographic markets or collaborate with third parties for products requiring a large sales and marketing force[94][95] Intellectual Property Revelation's success depends on obtaining and maintaining proprietary protection for its product candidates and technology through patents and trade secrets, including a licensed patent from Vanderbilt - Revelation's success relies on obtaining and maintaining patent protection and trade secret confidentiality for its product candidates, technology, and know-how[96][100] - The patent portfolio includes one patent family for MPLA formulations (Gemini), a PCT application for MPLA formulations as an allergy immunotherapy adjuvant, and a patent family for MPLA formulations in preventing acute and chronic organ disease[97] - The company has licensed a patent from Vanderbilt University for methods of using PHAD for treating or preventing infections[97] Employees As of March 3, 2025, Revelation Biosciences had 8 full-time and one part-time employee, with good employee relations and no union representation - As of March 3, 2025, Revelation had 8 full-time and one part-time employee[101] - Five employees are engaged in research and development or operations, and four in general and administrative activities[101] Government Regulation Revelation's operations are extensively regulated by the FDA and other authorities, covering all stages from research to commercialization, with significant uncertainty regarding product coverage, pricing, and reimbursement - The FDA and other regulatory authorities extensively regulate the research, development, testing, manufacture, approval, and marketing of drugs, requiring substantial time and financial resources[102] - The U.S. drug approval process involves preclinical studies (GLP), an Investigational New Drug (IND) application, clinical trials (Phase 1, 2, 3) conducted under Good Clinical Practice (GCP), and a New Drug Application (NDA) for marketing approval[104][105][106][107][110] - Post-approval, products are subject to ongoing regulatory requirements, including manufacturing, labeling, advertising, and safety reporting, with non-compliance potentially leading to product withdrawal, fines, or other sanctions[115][168][169] - The company's operations are subject to U.S. healthcare fraud and abuse laws (Anti-Kickback Statute, False Claims Act, HIPAA, Sunshine Act) and data privacy regulations, with non-compliance carrying substantial penalties[117][118][122][125][215] - Significant uncertainty exists regarding coverage, pricing, and reimbursement for approved products, which are influenced by government health programs (Medicare, Medicaid) and private payors, as well as healthcare reforms like the ACA and Inflation Reduction Act (IRA)[132][133][134][137][140][141][142][146] ITEM 1A. RISK FACTORS. Revelation faces significant risks including limited operating history, recurring net losses, and dependence on future funding, raising substantial doubt about its going concern ability, compounded by product development uncertainties, regulatory delays, intense competition, and reliance on third parties - Revelation has a limited operating history, no approved products, and has incurred net losses since inception, with an accumulated deficit of $40.5 million as of December 31, 2024, raising substantial doubt about its ability to continue as a going concern[11][174][176][177] - The company's ability to generate revenue and achieve profitability depends on successfully completing development, obtaining regulatory approvals, and commercializing its Program Products, which are in early stages of development[180] - Clinical studies are expensive, lengthy, and uncertain, with a high failure rate, and delays or failures in preclinical or clinical studies, or non-acceptance of foreign clinical data by regulatory authorities, could prevent the company from meeting development goals[13][185][186][187][189][190] - Revelation relies heavily on third parties for preclinical and clinical studies, manufacturing, and supply of raw materials, including a single supplier for PHAD®, which introduces risks if these third parties fail to perform or meet deadlines[17][222][224][225] - The biopharmaceutical industry is intensely competitive, with many competitors possessing greater resources and experience, potentially leading to faster product development, market entry, or stronger intellectual property protection that could adversely affect Revelation's commercial success[13][83][87][217][219][220] - The company's intellectual property rights are uncertain, with risks that patent applications may not issue, issued patents may not effectively protect products, or that third parties may infringe or challenge existing IP, leading to costly litigation[17][241][242][247][255] - Compliance with extensive U.S. and international healthcare laws (e.g., Anti-Kickback, False Claims, HIPAA) and data protection regulations (e.g., GDPR, CCPA) is costly and complex, with potential for significant penalties for non-compliance[215][305][308][310][311][312] Risks Related to Our Business Revelation faces significant business risks including a limited operating history, no approved products, and consistent net losses, leading to substantial doubt about its ability to continue as a going concern, and requiring additional funding - Revelation has a limited operating history and no products approved for commercial sale, having incurred net losses since inception, with an accumulated deficit of $40.5 million as of December 31, 2024[174][175][176] - The company's current cash and cash equivalents are not sufficient to sustain operations for one year, raising substantial doubt about its ability to continue as a going concern[177] - Failure to obtain additional funding on acceptable terms could force the company to delay, scale back, or discontinue product development, or license rights on unfavorable terms, leading to dilution for existing stockholders if equity financing is pursued[181][182][183] Risks Related to the Product Development, Regulatory Approval, Manufacturing and Commercialization of Our Program Products and Product Candidates Product development is inherently risky, with potential for unsuccessful or delayed preclinical and clinical studies, regulatory non-approval, undesirable side effects, and intense competition from better-resourced companies - Unsuccessful or delayed preclinical or clinical studies for Program Products (GEM-AKI, GEM-CKD, GEM-PSI) will hinder future development goals, as drug development is lengthy, expensive, and has a high failure rate[185][186][188][189] - Clinical studies conducted outside the United States may not be accepted by the FDA or comparable foreign regulatory authorities, necessitating additional costly and time-consuming studies[190] - Undesirable side effects from Program Products could delay or prevent regulatory approval, limit commercial labeling, or lead to significant negative consequences post-marketing, including study termination or product withdrawal[197][198][199][200] - The company faces intense competition from well-established pharmaceutical and generic companies with greater resources, which may develop more effective, safer, or cheaper products, or achieve regulatory approval faster[217][218][219][220] Risks Related to our Reliance on Third Parties Revelation's dependence on third parties for preclinical and clinical studies, manufacturing, and raw material supply, including a single supplier for PHAD®, poses significant risks of delays, disruptions, and quality control issues - Revelation relies on third parties (CROs, medical institutions, consultants) to conduct preclinical and clinical studies, reducing control over these activities and posing risks if they fail to perform or comply with regulations[222][223] - The company depends on third-party suppliers for raw materials, including a single supplier for PHAD®, and lacks long-term supply agreements, risking supply disruptions and delays[224][226] - Reliance on third-party manufacturers for clinical and commercial production introduces risks such as failure to scale production, quality control problems, and operational disruptions (e.g., natural disasters), which could delay or impair product development and commercialization[225][227][229][230][231] - The company's information technology systems, and those of its third-party collaborators, are vulnerable to security breaches, cyber-attacks, and system failures, which could disrupt development programs, lead to data loss, and harm reputation and financial condition[237][238][239] Risks Related to Our Intellectual Property Revelation's success hinges on obtaining and maintaining effective patent rights and protecting trade secrets, which is challenging due to the complex and litigious nature of the biotechnology industry and global IP variations - The company's success depends on obtaining and maintaining effective patent rights for its product candidates and protecting trade secrets, which is uncertain and involves complex legal and factual questions[241][242][247][253] - Protecting intellectual property rights globally is expensive and challenging, as foreign laws may not offer the same level of protection as the U.S., potentially allowing competitors to use inventions without permission[248][249][250][251] - The company faces risks of insufficient patent lifespan due to the long development and regulatory review periods, potentially leading to early expiration of patent protection[252] - Revelation may be involved in costly and time-consuming lawsuits to protect its intellectual property or defend against claims of infringing others' rights, which could divert resources and harm its business[255][258][259][260] - Changes in U.S. and international patent law, including Supreme Court rulings and legislative actions, could diminish the value of patents and weaken the company's ability to obtain and enforce them[263] Risks Related to Our Business Operations Revelation's operational success depends on attracting and retaining key personnel, managing organizational growth, identifying new product candidates, and complying with environmental, health, safety, and healthcare laws - The company's future success depends on its ability to retain senior management and key employees, and to attract and motivate other qualified personnel in a highly competitive biotechnology industry[15][270][271] - Revelation will need to expand its organization and management capabilities to support preclinical and clinical development, regulatory approval, and commercialization, which may lead to difficulties in managing growth and strain existing resources[272][273][274][276] - There is a risk that the company may not be successful in identifying, discovering, or licensing additional product candidates, or that current development efforts may fail, potentially leading to abandonment of programs[277][278] - Failure to comply with environmental, health, and safety laws and regulations, particularly concerning hazardous materials, could result in fines, penalties, or costly clean-up, adversely affecting the business[279] - Ongoing healthcare legislative and regulatory reform measures, such as the ACA and IRA, could adversely affect the company's business, results of operations, and financial condition by impacting manufacturing, labeling, product pricing, and reimbursement[281][282][283][284][285][286] Risks Related to Commercialization of Our Program Products and Product Candidates As Revelation transitions to commercialization, it faces challenges in expanding operations, establishing sales and marketing, securing market acceptance and reimbursement, managing product liability, and complying with evolving data protection laws - As Revelation evolves from clinical development to commercialization, it faces difficulties in expanding operations, establishing sales and marketing capabilities, and managing relationships with third-party collaborators and distributors[287][288][289][290][295] - Profitability depends on market acceptance and adequate coverage/reimbursement from government authorities and third-party payors, which is uncertain and may require extensive cost-effectiveness data[297][298] - The business entails significant clinical study and product liability risks, with potential for costly claims, regulatory investigations, and product recalls, and current insurance coverage may be insufficient[300][301][302][323] - The company is exposed to risks of misconduct by employees, contractors, or partners, including non-compliance with regulatory standards and healthcare fraud and abuse laws, which could lead to significant penalties[303][304][305][307][309] - Global data protection laws (e.g., GDPR, CCPA) are rapidly evolving, increasing compliance costs and risks of non-compliance, potentially restricting data use and impacting operations[308][310][311][312] - Unstable market and economic conditions, including global credit disruptions, could adversely affect the business by making financing difficult, delaying clinical trials, or impacting third-party partners[184][314] - Penetrating foreign markets involves additional regulatory burdens, political/economic instability, trade restrictions, and challenges in obtaining regulatory approvals, pricing, and reimbursement[318][319][320][321][322] General Risk Factors Revelation's common stock price is subject to high volatility, and future sales by existing stockholders could depress its market price, while increased public company expenses and anti-takeover provisions pose additional risks - The company's common stock price may be volatile due to factors like development results, market conditions, competition, and investor perception, potentially leading to investment losses[328] - Potential future sales of common stock by existing stockholders, including officers and directors, could depress the market price[329] - Anti-takeover provisions in the company's charter and bylaws, along with Delaware law, could deter unsolicited takeover attempts and make it difficult for stockholders to change management[332][335] - Failure to comply with Nasdaq's continued listing requirements could result in delisting, leading to reduced liquidity and market quotations for its securities[336] - Warrants may be accounted for as warrant liabilities, and changes in their fair value could have a material non-cash impact on financial results[340] ITEM 1B. UNRESOLVED STAFF COMMENTS. There are no unresolved staff comments from the SEC - The company has no unresolved staff comments[341] ITEM 1C. CYBERSECURITY Revelation Biosciences has a cybersecurity policy in place, deemed appropriate for its limited threat profile, with IT and cybersecurity managed by external consultants and no incidents reported to date - The company employs a cybersecurity policy appropriate for its limited threat profile, as it does not possess personally identifiable patient, credit, or banking information[342] - Information systems and maintenance are delegated to independent IT and cybersecurity consultants who report to the CFO and the Board's Audit Committee[342] - The company has never been affected by cybersecurity incidents and uses third-party cloud service providers (e.g., Microsoft) for additional protection[342][343] ITEM 2. PROPERTIES Revelation's corporate headquarters are in San Diego, California, and it leases 2,140 square feet of laboratory space, which is considered adequate for current needs - The corporate headquarters are located at 4660 La Jolla Village Drive, Suite 100, San Diego, California, with office space available on an as-needed basis[344] - The company leases 2,140 square feet of laboratory space at 11011 Torreyana Road, Suite 102, San Diego, California[344] - The laboratory lease expires on February 28, 2025, and will continue on a month-to-month basis; the company believes it can obtain additional space as needed[344] ITEM 3. LEGAL PROCEEDINGS. Revelation Biosciences is not currently a party to any material legal proceedings, nor is it aware of any pending or threatened litigation - The company is not a party to any material legal proceedings and is unaware of any material pending or threatened litigation[345] ITEM 4. MINE SAFETY DISCLOSURES. Mine Safety Disclosures are not applicable to Revelation Biosciences - Mine Safety Disclosures are not applicable[346] Part II ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES. Revelation's common stock and public warrants are traded on the Nasdaq Capital Market, with approximately 23 common stockholders and 29 warrant holders, and no dividends have ever been paid - Revelation's common stock (REVB) and Public Warrants (REVBW) are traded on the Nasdaq Capital Market[348] - As of March 3, 2025, there were approximately 23 stockholders of record for common stock and 29 for warrants[349] - The company has never paid dividends on its common stock and does not plan to do so in the foreseeable future[350] ITEM 6. [RESERVED] This item is reserved and not applicable to Revelation Biosciences - Item 6 is reserved and not applicable[351] ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS. Revelation Biosciences, a clinical-stage company, incurred significant net losses and has insufficient cash to sustain operations for one year, raising substantial doubt about its going concern ability, and relies on additional funding for R&D and commercialization - Revelation is a clinical-stage life science company focused on developing therapies based on its Gemini platform for AKI, CKD, and PSI[354] - The company incurred a net loss of $15.0 million for the year ended December 31, 2024, compared to $0.1 million in 2023, and had an accumulated deficit of $40.5 million as of December 31, 2024[358][369] - As of December 31, 2024, the company had $6.5 million in cash and cash equivalents, which is not anticipated to be sufficient to sustain operations for one year, raising substantial doubt about its ability to continue as a going concern[356][373][377] - Research and development expenses decreased by $0.6 million to $3.5 million in 2024, primarily due to lower other program and manufacturing expenses, offset by increased clinical study and personnel costs[370] - General and administrative expenses decreased by $0.1 million to $4.4 million in 2024, mainly due to lower legal and professional fees, offset by increased personnel expenses[371] - Net cash used in operating activities increased significantly to $18.3 million in 2024 from $7.3 million in 2023[380][381][382] Overview Revelation Biosciences is a clinical-stage company focused on its Gemini platform, having incurred recurring losses and with insufficient cash for one year of operations, raising going concern doubts and necessitating future funding - Revelation is a clinical-stage life science company focused on rebalancing inflammation using its proprietary Gemini formulation for GEM-AKI, GEM-CKD, and GEM-PSI[354] - Since inception, operations have been funded by capital stock sales, raising net proceeds of $56.7 million, with $12.8 million received in 2024[356][373] - The company incurred a net loss of $15.0 million in 2024 and $0.1 million in 2023, with an accumulated deficit of $40.5 million as of December 31, 2024[358] - Current cash and cash equivalents are not sufficient to sustain operations for one year, raising substantial doubt about the company's ability to continue as a going concern[356] Recent Developments Revelation recently completed a 1-for-16 reverse stock split on January 28, 2025, and regained compliance with Nasdaq's minimum bid price requirement by February 19, 2025 - On January 28, 2025, the company effected a 1-for-16 reverse stock split[361] - Revelation regained compliance with Nasdaq's minimum bid price requirement by February 19, 2025, after previously being notified of noncompliance[362] Research and Development Research and development expenses, primarily for GEM-AKI, GEM-CKD, and GEM-PSI programs, decreased by $0.6 million in 2024 to $3.5 million, but are anticipated to increase substantially as product candidates advance - Research and development expenses primarily consist of external clinical development costs, CROs, consultants, manufacturing clinical study materials, regulatory submissions, laboratory supplies, and personnel costs[363] Research and Development Expenses (Year Ended December 31) | Expense Category | 2024 ($) | 2023 ($) | Change ($) | | :--------------------------------- | :--------- | :--------- | :--------- | | GEM-AKI, GEM-CKD and GEM-PSI clinical study expenses | 1,681,731 | 209,702 | 1,472,029 | | Manufacturing expenses | 390,022 | 697,429 | (307,407) | | Other program expenses | 77,679 | 2,190,493 | (2,112,814) | | Other expenses | 172,369 | 282,948 | (110,579) | | Personnel expenses (including stock-based compensation) | 1,227,195 | 765,330 | 461,865 | | Total research and development expenses | 3,548,996 | 4,145,902 | (596,906) | - R&D expenses decreased by $0.6 million in 2024, driven by decreases in other program expenses ($2.1 million) and manufacturing expenses ($0.3 million), partially offset by increases in clinical study expenses ($1.5 million) and personnel expenses ($0.5 million)[370] General and Administrative General and administrative expenses, covering personnel and professional services, decreased by $0.1 million in 2024 to $4.4 million, mainly due to reduced legal fees, but are expected to increase with company growth - General and administrative expenses primarily consist of personnel costs, and outside professional services (financial advisory, legal, HR, audit, accounting)[367] General and Administrative Expenses (Year Ended December 31) | Expense Category | 2024 ($) | 2023 ($) | Change ($) | | :----------------------------------------- | :--------- | :--------- | :--------- | | Personnel expenses (including employee stock-based compensation) | 2,768,602 | 2,272,005 | 496,597 | | Legal and professional fees | 1,274,567 | 1,844,077 | (569,510) | | Other expenses | 382,944 | 394,680 | (11,736) | | Total general and administrative expenses | 4,426,113 | 4,510,762 | (84,649) | - G&A expenses decreased by $0.1 million in 2024, primarily due to a $0.6 million decrease in legal and professional fees, offset by a $0.5 million increase in personnel expenses[371] Other (Expense) Income, Net Other (expense) income, net, shifted from an $8.5 million income in 2023 to a ($7.1) million expense in 2024, driven by judgment expenses, settlement costs, and deferred underwriting commissions - Other (expense) income, net, was $8,536,410 in 2023, primarily from the change in fair value of warrant liability, foreign currency transaction gains/losses, and interest income[372] - In 2024, other (expense) income, net, was ($7,063,427), mainly due to LifeSci Capital LLC judgment expense, clinical trial related settlement expenses, and deferred underwriting commissions, partially offset by interest income[372] Results of Operations Revelation reported a net loss of $15.0 million in 2024, a significant increase from $0.1 million in 2023, primarily due to a shift from positive other income to a substantial other expense Consolidated Results of Operations (Year Ended December 31) | Metric | 2024 ($) | 2023 ($) | Change ($) | | :-------------------------- | :--------- | :--------- | :--------- | | Total operating expenses | 7,975,109 | 8,656,664 | (681,555) | | Loss from operations | (7,975,109) | (8,656,664) | 681,555 | | Total other (expense) income, net | (7,063,427) | 8,536,410 | (15,599,837) | | Net loss | (15,038,536) | (120,254) | (14,918,282) | | Net loss per share, basic and diluted | (87.68) | (8.44) | (79.24) | | Weighted-average shares used | 171,510 | 14,246 | 157,264 | Liquidity and Capital Resources Revelation has raised $56.7 million in net proceeds since inception, but with $6.5 million cash and a $40.5 million accumulated deficit as of December 31, 2024, it faces a going concern risk and needs additional funding - Since inception to December 31, 2024, Revelation funded operations through capital stock sales, raising net proceeds of $56.7 million, including $12.8 million in 2024[373] - As of December 31, 2024, the company had $6.5 million in cash and cash equivalents and an accumulated deficit of $40.5 million[373] - The current cash balance is not expected to sustain operations for one year, raising substantial doubt about the company's ability to continue as a going concern[377] - The company plans to seek additional funding through public or private equity offerings, debt financings, or collaborations, which could dilute existing stockholders or impose restrictive covenants[376][378] Cash Flows In 2024, net cash used in operating activities significantly increased to $18.3 million, partially offset by $12.8 million from financing activities, resulting in a net decrease in cash and cash equivalents of $5.5 million Consolidated Statements of Cash Flows (Year Ended December 31) | Cash Flow Activity | 2024 ($) | 2023 ($) | | :--------------------------------- | :--------- | :--------- | | Net cash used in operating activities | (18,321,276) | (7,286,286) | | Net cash used in investing activities | (19,171) | - | | Net cash provided by financing activities | 12,847,764 | 14,025,008 | | Net (decrease) increase in cash and cash equivalents | (5,492,683) | 6,738,722 | | Cash and cash equivalents at end of period | 6,499,018 | 11,991,701 | - Net cash used in operating activities was $18.3 million in 2024, consisting of a $15.0 million net loss and a $3.4 million net change in operating assets and liabilities[381] - Net cash provided by financing activities was $12.8 million in 2024, primarily from the February 2024 Public Offering ($5.4 million) and proceeds from various warrant exercises ($7.4 million)[385] Contractual Obligations and Other Commitments As of December 31, 2024, Revelation's only material contractual obligation is $10,700 in operating lease payments due within one year for its laboratory space, with other contracts generally cancellable Contractual Obligations as of December 31, 2024 | Obligation Type | Less than 1 year ($) | 1 to 3 years ($) | 3 to 5 years ($) | More than 5 years ($) | Total ($) | | :---------------------- | :------------------- | :--------------- | :--------------- | :-------------------- | :-------- | | Operating lease obligations | 10,700 | — | — | — | 10,700 | - The company's non-cancelable obligations under contracts with third-party service providers and vendors are not considered material[388] Off-Balance Sheet Arrangements As of December 31, 2024, Revelation Biosciences did not have any off-balance sheet arrangements as defined by SEC Regulation S-K - As of December 31, 2024, the company did not have any off-balance sheet arrangements[389] Quantitative and Qualitative Disclosure about Market Risk Revelation Biosciences is exposed to market risks, primarily interest rate and foreign currency risk, though these have not been material to date, and the company does not have a formal hedging program - The company's cash and cash equivalents are primarily in highly liquid, short-term investments, making the fair value not significantly affected by interest rate changes[391] - Revelation is subject to foreign currency transaction gains or losses from R&D payments denominated in Australian Dollars and British Pounds, but these have not been material to date, and there is no formal hedging program[392] Critical Accounting Policies and Significant Judgments and Estimates The preparation of Revelation's financial statements requires significant estimates and assumptions for R&D expenses, stock-based compensation, income taxes, and fair value measurements, particularly for warrant liabilities - All research and development costs are expensed as incurred, with accruals for third-party contractor work, clinical trial sites, and professional services[394][395] - Stock-based compensation expense for stock options, third-party warrants, and RSU awards is recognized based on estimated fair value at grant date, using the Black-Scholes model for options and warrants[396] - Deferred tax assets and liabilities are recognized for future tax consequences, with a valuation allowance established against deferred tax assets due to uncertainty of realization[393][532] - The fair value of Class C Common Stock Warrants is a Level 3 measurement, valued using a Monte-Carlo simulation model, and classified as current liabilities due to specific exercise provisions[393][535][537][538] ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK. As a smaller reporting company, Revelation Biosciences is not required to provide quantitative and qualitative disclosures about market risk - As a smaller reporting company, Revelation Biosciences is not required to provide quantitative and qualitative disclosures about market risk[399] ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA. The financial statements and supplementary data required for this item are incorporated by reference and can be found starting on page F-1 of this Annual Report on Form 10-K - The financial statements and supplementary data are set forth at the end of this Annual Report on Form 10-K, beginning on page F-1, and are incorporated by reference[400] ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE. Revelation Biosciences reports no changes in or disagreements with its accountants on accounting and financial disclosure matters - There have been no changes in or disagreements with accountants on accounting and financial disclosure[401] ITEM 9A. CONTROLS AND PROCEDURES. Revelation's management concluded that its disclosure controls and procedures and internal control over financial reporting were effective as of December 31, 2024, with no material changes during the most recent quarter - As of December 31, 2024, management concluded that the company's disclosure controls and procedures were effective at the reasonable assurance level[403] - Management assessed and concluded that the internal control over financial reporting was effective as of December 31, 2024, based on the COSO framework[404][406] - There were no changes in internal control over financial reporting during the most recent quarter that materially affected, or are reasonably likely to materially affect, internal control over financial reporting[407] ITEM 9B. OTHER INFORMATION. Revelation Biosciences reports no other information required under this item - There is no other information to report under this item[408] ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS. Revelation Biosciences states that this disclosure item regarding foreign jurisdictions that prevent inspections is not applicable - Disclosure regarding foreign jurisdictions that prevent inspections is not applicable[409] Part III ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE. Revelation Biosciences' corporate governance structure includes a classified Board of Directors with staggered three-year terms and appointed officers, with the Board overseeing risk management through its committees - The Board of Directors is divided into three classes with staggered three-year terms, and officers are appointed by the Board[418] - The Board oversees risk management directly and through its Audit, Nominating and Corporate Governance, and Compensation Committees[425][426] - All directors, except CEO James Rolke, are considered independent according to SEC and Nasdaq rules[471] - The Audit Committee, chaired by Jess Roper (a financial expert), is responsible for auditor engagement, financial review, related party transactions, and cybersecurity oversight[429] - The company has adopted a Code of Ethics applicable to all employees, including executive and financial officers[433] Executive Officers and Directors The company's leadership includes George Tidmarsh (Chairman), James Rolke (Director and CEO), Jennifer Carver (Director), Jess Roper (Director), Lakhmir Chawla (Director), and Chester S. Zygmont, III (CFO) Executive Officers and Directors (as of March 3, 2025) | Name | Age | Position | | :-------------------------- | :-- | :-------------------------- | | BOARD OF DIRECTORS | | | | George Tidmarsh, M.D., Ph.D. | 65 | Chairman and Director | | James Rolke | 56 | Director and Chief Executive Officer | | Jennifer Carver, BSN, MBA | 71 | Director | | Jess Roper | 60 | Director | | Lakhmir Chawla, M.D. | 54 | Director | | EXECUTIVE OFFICERS | | | | James Rolke | 56 | Director and Chief Executive Officer | | Chester S. Zygmont, III | 44 | Chief Financial Officer | Our Director and Executive Officers The executive team and directors bring extensive biopharmaceutical and financial expertise, with key leaders like Dr. George Tidmarsh (Chairman) and James Rolke (CEO) having decades of industry experience - Dr. George Tidmarsh, Chairman, has over 30 years of biotechnology experience, including leading the development of seven FDA-approved drugs[412] - James Rolke, CEO, co-founded Revelation and has over 30 years of experience across all phases of drug development[413] - Chester S. Zygmont, III, CFO, has over 20 years of finance experience and co-founded Jivanas and oOxesis Biotechnology, LLC[417] Number and Terms of Office of Officers and Directors Revelation's Board of Directors is classified into three groups with staggered three-year terms, and officers are appointed by the Board to serve until a successor is named or until termination - The Board is divided into three classes (Class A, B, and C), with directors serving staggered three-year terms[418] - Officers are appointed by the Board and serve until a successor is appointed or until earlier termination[419] Family Relationships There are no family relationships among Revelation's directors or executive officers - There are no family relationships among the company's directors or executive officers[420] Involvement in Certain Legal Proceedings None of Revelation's directors, executive officers, promoters, or control persons have been involved in any legal proceedings requiring disclosure - None of the directors, executive officers, promoters, or control persons have been involved in any legal proceedings requiring disclosure[421] Board Composition Revelation's board of directors is classified into three classes with staggered three-year terms, which may delay changes in management or control, with specific terms expiring in 2025, 2026, and 2027 - The board of directors is divided into three classes with staggered three-year terms, which could delay changes in management or control[422][423] - Class A directors (Dr. Chawla, Ms. Carver) terms expire in 2026; Class B directors (Messrs. Rolke, Roper) terms expire in 2027; Class C director (Dr. Tidmarsh) term expires in 2025[426] Leadership Structure of the Board The company's bylaws allow for flexibility in combining or separating the roles of Chairman and Chief Executive Officer, with the Board periodically reviewing and deeming its current structure appropriate - The board's leadership structure allows for flexibility in combining or separating the positions of Chairman and Chief Executive Officer[424] - The current leadership structure is deemed appropriate and is subject to periodic review[424] Role of Board in Risk Oversight Process Revelation's Board of Directors, along with its standing committees, plays an integral role in risk assessment and oversight, covering financial, governance, and compensation-related risks - Risk assessment and oversight are integral to the company's governance, with management discussing risks at regular meetings and strategic planning sessions[425] - The Board administers risk oversight directly and through its Audit Committee (financial risks), Nominating and Corporate Governance Committee (governance), and Compensation Committee (compensation policies)[426] Attendance of Directors at Board Meetings and Annual Meeting of Stockholders In 2024, all directors attended 100% of the Board and committee meetings during their terms of service, with Mr. Rolke attending the Annual Meeting of Stockholders - In 2024, all directors attended 100% of the Board and committee meetings during their terms of service[427] - Mr. Rolke attended the 2024 Annual Meeting of Stockholders; the company does not have a policy requiring director attendance[427] Board Committees The Board has established an Audit Committee, a Nominating and Governance Committee, and a Compensation Committee, each with a written charter, to oversee financial reporting, governance, and executive compensation - The Board has established an Audit Committee, a Compensation Committee, and a Nominating and Corporate Governance Committee, each with a written charter[428] - The Audit Committee, composed of Mr. Roper (Chair, financial expert), Dr. Tidmarsh, and Ms. Carver, oversees independent auditors, financial statements, related party transactions, and risk assessment[429] - The Nominating and Governance Committee identifies director nominees, evaluates board performance, and reviews corporate governance practices[430] - The Compensation Committee, composed of independent directors, oversees compensation and benefits for officers and employees, and reviews the CEO's compensation[431] ITEM 11. EXECUTIVE OFFICER AND DIRECTOR COMPENSATION. Revelation's executive compensation for named executive officers includes base salary, annual performance bonuses, and long-term equity incentive grants, with non-employee directors receiving cash and equity compensation - Executive compensation for named executive officers (CEO James Rolke and CFO Chester S. Zygmont, III) includes base salary, annual performance bonuses, and long-term incentive compensation in the form of restricted common stock awards and incentive stock options[434][438] - Executive Employment Agreements provide for annual base salaries (e.g., Mr. Rolke: $589,050 in 2025; Mr. Zygmont: $425,250 in 2025) and target annual performance bonuses (50% for CEO, 40% for CFO)[436] - Severance provisions include lump sum payments and medical benefit continuation for 'Covered Termination Events,' with accelerated vesting of equity awards if in connection with a change in control[437] Summary Compensation Table (Year Ended December 31) | Name and Position | Year | Salary ($) | Bonus ($) | All other compensation ($) | Total compensation ($) | | :------------------ | :--- | :--------- | :-------- | :------------------------- | :--------------------- | | James Rolke, CEO | 2024 | 561,000 | 237,500 | 14,726 | 813,226 | | | 2023 | 475,000 | 160,000 | 14,250 | 649,250 | | Chester S. Zygmont, III, CFO | 2024 | 405,000 | 142,579 | 16,427 | 564,006 | | | 2023 | 356,448 | 112,000 | 10,693 | 479,141 | - Non-employee directors received $60,000 in cash fees in 2024, with no option-based awards reported for that year[461] - Compensation actually paid to NEOs is generally aligned with the company's cumulative total stockholder return due to the significant portion of equity awards, but not necessarily aligned with net loss[456][458] ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS. As of March 3, 2025, Revelation Biosciences had 905,228 shares of common stock outstanding, with all directors and officers collectively owning 5.0% and no single individual or group holding more than 5% beneficial ownership - As of March 3, 2025, there were 905,228 shares of common stock issued and outstanding[464] Beneficial Ownership of Common Stock (as of March 3, 2025) | Name | Number of Shares Beneficially Owned | Beneficial Ownership (%) | | :-------------------------------- | :------