Revelation Biosciences (REVB) risk factors, FY2024 10-K

Risks Related to Our Business

1. 01The net losses we incur may fluctuate significantly from quarter-to-quarter such that a period-to-period comparison of our results of operations may not be a good indication of our future performance
2. 02relinquish, or license on unfavorable terms, our rights to technologies or any product candidates that we otherwise would seek to develop or commercialize ourselves

Risks Related to the Product Development, Regulatory Approval, Manufacturing and

1. 03If preclinical studies or clinical studies for our Program Products are unsuccessful or delayed, we will be unable to meet our future development goals
2. 04We are focused on the development of GEM-AKI, GEM-CKD, and GEM-PSI which are in pre-clinical development working towards early clinical trials
3. 05The Clinical Studies of our Program Products’ have been and are planned to be conducted outside the United States, and the FDA or comparable foreign regulatory authorities may not accept data from such studies
4. 06As an organization, we have never conducted pivotal clinical studies, and we may be unable to do so for any Program Products we may develop
5. 07We may find it difficult to enroll patients in our clinical studies, which could delay or prevent us from proceeding with clinical studies
6. 08Our Program Products and the administration of our Program Products may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label or result in significant negative consequences following marketing approval, if any
7. 09Interim, topline and preliminary data from our clinical studies that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data
8. 10Even if we complete the necessary clinical studies, we cannot predict when, or if, we will obtain regulatory approval to commercialize any of our Program Products, and the approval may be for a more narrow indication than we seek or be subject to other limitations or restrictions that limit its commercial profile
9. 11Our business depends on the success of our Program Products, including obtaining regulatory approval to market our product candidates in the United States and/or other major foreign markets such as the EU
10. 12we may not be able to obtain, maintain or enforce our patents and other intellectual property rights
11. 13If we or any of our future development collaborators are unable to develop, or obtain regulatory approval for, or, if approved, successfully commercialize our Program Products, we may not be able to generate sufficient revenue to continue our business
12. 14Even if we obtain regulatory approval for a product candidate, our products and business will remain subject to ongoing regulatory obligations and review
13. 15The occurrence of any event or penalty described above may inhibit our ability to commercialize our products and generate product revenue
14. 16Legislative or regulatory healthcare reforms in the United States or other countries may make it more difficult and costly for us to obtain regulatory clearance or approval of our Program Products and to produce, market and distribute our Program Products after clearance or approval is obtained
15. 17The pharmaceutical industry in which we operate is intensely competitive and subject to rapid and significant technological change. We are currently aware of various existing therapies in the market and in development that may in the future compete with our Program Products

Risks Related to our Reliance on Third Parties

1. 18reliance on the third party for regulatory compliance, quality assurance and safety and pharmacovigilance reporting
2. 19Our current and anticipated future dependence upon others for the manufacture of our product candidates may adversely affect our future profit margins and our ability to develop our product candidates and commercialize any products that receive regulatory approval on a timely basis
3. 20We may not be able to obtain and maintain the third-party relationships that are necessary to develop, commercialize and manufacture some or all of our product candidates

Risks Related to Our Intellectual Property

1. 21In countries where we have not sought and do not seek patent protection, third parties may be able to manufacture and sell our product candidates without our permission, and we may not be able to stop them from doing so
2. 22We may not be able to protect our intellectual property rights throughout the world
3. 23We may not have sufficient patent lifespan to effectively protect our products and business
4. 24If we are unable to maintain effective proprietary rights for our Program Products or any future product candidates, we may not be able to compete effectively in our markets
5. 25We may be involved in lawsuits to protect or enforce our intellectual property, which could be expensive, time-consuming and unsuccessful
6. 26We may infringe the intellectual property rights of others, which could increase our costs and delay or prevent our development efforts
7. 27Changes in United States and international patent law could diminish the value of patents in general, thereby impairing our ability to protect our products
8. 28Our inability to protect our trade secrets would harm our business and competitive position
9. 29Intellectual property rights do not necessarily address all potential threats
10. 30If our trademarks and trade names are not maintained and adequately protected, we may not be able to build name recognition in our markets of interest, and our business may be adversely affected

Risks Related to Our Business Operations

1. 31Our future success depends in part on our ability to retain our senior management team, directors and other key employees and to attract, retain and motivate other qualified personnel
2. 32We are in the early stages of building the full management team and employee base that we anticipate we will need to complete the development of our Program Products and other future product candidates. As of March 3, 2025, we had 9 employees
3. 33In addition, in order to continue to meet our obligations as a public company and to support our anticipated long-term growth, we will need to increase our general and administrative capabilities. Our management, personnel and systems may not be adequate to support this future growth
4. 34We may not be successful in our efforts to identify, discover or license additional product candidates
5. 35If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business
6. 36Ongoing healthcare legislative and regulatory reform measures may adversely affect our business, results of operations and financial condition

Risks Related to Commercialization of Our Program Products and Product Candidates

1. 37As we evolve from a company that is primarily involved in clinical development to a company that is also involved in commercialization, we may encounter difficulties in expanding our operations successfully
2. 38We may seek to establish commercial collaborations for our Program Products and future product candidates, and, if we are not able to establish them on commercially reasonable terms, we may have to alter our development plans
3. 39Collaborations are complex and time-consuming to negotiate and document. In addition, there have been a significant number of business combinations among large pharmaceutical companies that have resulted in a reduced number of potential future collaborators
4. 40It may be difficult for us to profitably sell our Program Products, if and when approved, if coverage and reimbursement for these Program Products are limited by government authorities and/or third-party payor policies
5. 41Our business entails a significant risk of clinical study and/or product liability and our ability to obtain sufficient insurance coverage could have a material effect on our business, financial condition, results of operations or prospects
6. 42Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop
7. 43the inability to commercialize any products that we may develop
8. 44Our employees, contractors, vendors, principal investigators, consultants and future partners may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements and insider trading
9. 45Our business operations and relationships with investigators, healthcare professionals, consultants, third-party payors, patient organizations and customers are subject to broadly applicable healthcare regulatory laws, which could expose us to penalties
10. 46Data collection is governed by restrictive regulations governing the collection, use, processing and cross-border transfer of personal information
11. 47Unstable market and economic conditions may have serious adverse consequences on our business and financial condition
12. 48Changes in our effective income tax rate could adversely affect our results of operations
13. 49Our future growth may depend, in part, on our ability to penetrate foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties
14. 50Foreign sales of our product candidates could also be adversely affected by the imposition of governmental controls, political and economic instability, trade restrictions and changes in tariffs
15. 51production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad
16. 52We face the risk of product liability claims and may not be able to obtain insurance
17. 53Our insurance policies are expensive and protect us only from some business risks, which will leave us exposed to significant uninsured liabilities
18. 54We have no current plans to pay dividends on our shares of common stock
19. 55Loss of Emerging Grown Company Status
20. 56Reduced flexibility: We can no longer use EGC exemptions for test-the-waters communications or scaled executive compensation disclosures
21. 57Our common stock price may be volatile and as a result you could lose all or part of your investment
22. 58Potential future sales pursuant to registration rights granted by the Company and under Rule 144 may depress the market price for our shares of common stock
23. 59FINRA has adopted sales practice requirements, which may also limit a stockholder’s ability to buy and sell our common stock
24. 60We face risks related to compliance with corporate governance laws and financial reporting standards
25. 61Our Charter contains provisions that may discourage unsolicited takeover proposals that stockholders may consider to be in their best interests. We are also subject to anti-takeover provisions under Delaware law, which could delay or prevent a change of control
26. 62a prohibition on stockholder action by written consent, which forces stockholder action to be taken at an annual or special meeting of our stockholders
27. 63If Revelation is not able to comply with the applicable continued listing requirements or standards of Nasdaq, Nasdaq could delist our common stock
28. 64Revelation will continue to incur significant increased expenses and administrative burdens as a public company, which could negatively impact its business, financial condition and results of operations
29. 65Revelation’s business and operations could be negatively affected if it becomes subject to any securities litigation or stockholder activism, which could cause Revelation to incur significant expense, hinder execution of business and growth strategy and impact its stock price
30. 66Our common stock warrants may be accounted for as warrant liabilities and the changes in value of our warrants could have a material effect on our financial results