Serina Therapeutics (SER) risk factors, FY2024 10-K

Risks Related to Our Operating History, Financial Position and Capital Requirements

1. 01We have a history of operating losses that are expected to continue for the foreseeable future, and we are unable to predict the extent of future losses, or whether we will generate significant revenues or achieve or sustain profitability
2. 02Because we are an early-stage company, our prospects must be considered in light of the uncertainties, risks, expenses, and difficulties frequently encountered by companies in their early stages of operations
3. 03We are dependent on obtaining, and will continue to pursue, necessary funding from outside sources, including obtaining additional funding from the issuance of securities in order to continue our operations. Without adequate funding, we may not be able to meet our financial obligations
4. 04manufacturing the applicable products and product candidates in accordance with regulatory requirements and, if ultimately approved, conducting sales and marketing activities in accordance with health care, FDA and similar foreign regulatory authority laws and regulations
5. 05We have never generated revenue from product sales and may never become profitable
6. 06attract, hire, and retain qualified personnel

Risks Related to the Development of Our Products

1. 07Our product candidates are at an early stage of development and may not be successfully developed or commercialized
2. 08Furthermore, we expect to rely on CROs and clinical trial sites to ensure the proper and timely conduct of our clinical trials and, while we expect to enter into agreements governing their committed activities, we have limited influence over their actual performance
3. 09Preliminary results from our nonclinical studies and clinical trials that we announce or publish from time to time may change as more patient data becomes available and as the data undergoes audit and verification procedures
4. 10The FDA or comparable foreign regulatory authorities may disagree with our regulatory plans, and we may fail to obtain regulatory approval of our product candidates
5. 11We may not be successful in our efforts to use and expand our discovery engine to build a pipeline of product candidates
6. 12a product candidate may not be accepted as safe and effective by patients, the medical community, or third-party payors, if applicable
7. 13We may seek designations under the FDA’s expedited programs for serious conditions, such as fast track or breakthrough therapy designation, which are intended to facilitate and expedite the development or regulatory review or approval process for product candidates
8. 14We may seek an accelerated approval development pathway for our product candidates
9. 15If we apply for orphan drug designation from the FDA, there is no guarantee that we will be able to obtain or maintain this designation, receive this designation for any of our other product candidates, or receive or maintain any corresponding benefits, including periods of exclusivity
10. 16We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success
11. 17If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected
12. 18the risk that subjects enrolled in clinical trials will drop out of the trials before completion of the study or not return for post study follow up, especially subjects in control groups
13. 19Any product candidate we advance into clinical trials may cause unacceptable adverse events or have other properties that may delay or prevent our regulatory approval or commercialization or limit our commercial potential
14. 20our reputation may suffer
15. 21We may form or seek strategic partnerships or enter into additional licensing arrangements in the future, and we may not realize the benefits of such alliances or licensing arrangements
16. 22We rely on contract manufacturing organizations to manufacture our nonclinical and clinical pharmaceutical supplies and expect to continue to rely on CMOs to produce commercial supplies of any approved product candidate, and our dependence on CMOs could adversely impact our business
17. 23We rely on other third parties to store and distribute our product candidates for nonclinical studies and clinical trials that we conduct
18. 24We may incur substantial product liability or indemnification claims relating to the clinical testing of our product candidates
19. 25product recalls, withdrawals, revocation of approvals, or labeling, marketing or promotional restrictions

Risks Related to Our Business, Industry and Future Commercialization

1. 26If any product candidate that we successfully develop does not achieve broad market acceptance among physicians, patients, health care payors and the medical community, the revenues that we generate from their sales will be limited
2. 27potential product liability claims
3. 28If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to sell and market any product candidates we may develop, we may not be successful in commercializing those product candidates if and when they are approved
4. 29unforeseen costs and expenses associated with creating an independent commercialization organization
5. 30Corporate and academic collaborators may take actions to delay, prevent, or undermine the success of our products
6. 31Data provided by collaborators and others upon which we rely that has not been independently verified could turn out to be false, misleading, or incomplete
7. 32Even if we are able to commercialize any product candidates, such products may become subject to unfavorable pricing regulations, reimbursement practices, or health care reform initiatives, which would harm our business
8. 33Our insurance policies are expensive and protect us only from some business risks, which will leave us exposed to significant uninsured liabilities

Risks Related to Our Intellectual Property

1. 34Our success is largely based upon our intellectual property and proprietary technologies, and we may be unable to protect and/or enforce our intellectual property
2. 35we may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time consuming and/or unsuccessful
3. 36We may be forced to litigate to enforce or defend our intellectual property rights, and/or the intellectual property rights of our licensors
4. 37If we or our partners are sued for infringing on the intellectual property rights of third parties, it could be costly and time consuming, and an unfavorable outcome in any such litigation could have a material adverse effect on our business
5. 38obtain one or more licenses from third parties for an upfront lump sum, an ongoing royalty, or a combination thereof
6. 39Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment, and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements
7. 40If we do not obtain patent term extension for our drug candidates, our business may be materially harmed
8. 41Changes in patent law in the United States and in non U.S. jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our technologies and product candidates
9. 42Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time
10. 43If we are unable to protect the confidentiality of our trade secrets, our business and competitive position could be harmed
11. 44Third parties may assert that our employees, consultants, or advisors have wrongfully used or disclosed confidential information or misappropriated trade secrets
12. 45Any trademarks we may obtain may be infringed or successfully challenged, resulting in harm to our business
13. 46Intellectual property rights do not necessarily address all potential threats
14. 47the patents of others may prohibit or otherwise harm our business; or

Risks Related to Regulatory and Compliance Matters

1. 48The FDA regulatory approval process is lengthy, time consuming, and inherently unpredictable, and we may experience significant delays in the clinical development and regulatory approval, if any, of our product candidates
2. 49Even if we receive regulatory approval of our product candidates, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense, and we may be subject to penalties if we fail to comply with regulatory requirements
3. 50injunctions or the imposition of civil or criminal penalties; and
4. 51Additional regulatory burdens and other risks and uncertainties in foreign markets may limit our growth
5. 52Health care and other reform legislation may increase the difficulty and cost for us and any collaborators we may have to obtain marketing approval of and commercialize our product candidates and affect the prices we, or they, may obtain
6. 53Our employees, principal investigators, consultants, and commercial partners may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading
7. 54Laws and regulations governing any international operations we may have in the future may preclude us from developing, manufacturing, and selling certain product candidates outside of the United States and require us to develop and implement costly compliance programs

Risks Related to Employee and Operations Matters, Managing Growth and Information Technology

1. 55A pandemic, epidemic, or outbreak of an infectious disease, may materially and adversely affect our business and our financial results and could cause a disruption to the development of product candidates
2. 56Even after an outbreak or pandemic subsides, we may continue to experience an adverse impact to our business as a result of our global economic impact, including from increased inflation and the prospect that policy responses to inflation could delay economic recovery or lead to another recession
3. 57Our future success depends on our ability to recruit and retain our executive team and key scientists and to attract, retain, and motivate qualified personnel
4. 58If we are unable to hire additional qualified personnel, our ability to grow our business may be harmed
5. 59We expect to expand our development, regulatory, and future sales and marketing capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations
6. 60increasing in frequency and evolving in nature. Additionally, due to geopolitical tensions related to Russia’s invasion of Ukraine, the risk of cyber-attacks may be elevated
7. 61If we fail to maintain proper and effective internal controls, our ability to produce accurate financial statements on a timely basis could be impaired
8. 62Unfavorable global economic conditions could adversely affect our business, financial condition, or results of operations
9. 63We face risks associated with increased political uncertainty
10. 64Changes in U.S. and international trade policies, particularly with respect to China, may adversely impact our business and operating results

Risks Related to the Company

1. 65We will need to raise additional financing in the future to fund our operations, which may not be available to us on favorable terms or at all
2. 66Transfers of our securities utilizing Rule 144 of the Securities Act may be limited
3. 67The Merger made us subject to the SEC requirements applicable to reporting shell company business combinations. As a result, we will be subject to more stringent reporting requirements, offering limitations, and resale restrictions
4. 68The market price of our common stock is expected to be volatile
5. 69Moreover, the stock markets in general have experienced substantial volatility that has often been unrelated to the operating performance of individual companies. These broad market fluctuations may also adversely affect the trading price of our common stock
6. 70We will incur costs and demands upon management as a result of complying with the laws, rules and regulations affecting public companies
7. 71Anti-takeover provisions in our governance documents and under Delaware law could make an acquisition of Serina more difficult and may prevent attempts by our stockholders to replace or remove our management
8. 72We do not anticipate paying any cash dividends in the foreseeable future
9. 73An active trading market for our common stock may not develop and our stockholders may not be able to resell their shares of common stock for a profit, if at all
10. 74Future sales of shares by existing stockholders could cause our stock price to decline
11. 75If equity research analysts do not publish research or reports, or publish unfavorable research or reports, about us, our business or our market, our stock price and trading volume could decline
12. 76If we fail to attract and retain management and other key personnel, we may be unable to continue to successfully develop or commercialize our product candidates or otherwise implement our business plan
13. 77We expect to take advantage of reduced disclosure and governance requirements applicable to smaller reporting companies, which could result in our common stock being less attractive to investors
14. 78Changes in tax laws may materially adversely affect our business, prospects, financial condition and operating results
15. 79Our ability to use net operating loss (NOL) carryforwards and other tax attributes may be limited, including as a result of the Merger
16. 80Juvenescence Limited (“Juvenescence”) owns approximately 40.5% of the outstanding shares of our common stock, including our common stock subject to warrants held by Juvenescence. See “Principal Stockholders of the Company” for additional information