Sana Biotechnology (SANA) risk factors, FY2024 10-K

Risks Related to Our Business and Industry

1. 01If we are unable to successfully identify, develop, and commercialize any product candidates, or experience significant delays in doing so, our business, financial condition, and results of operations will be materially adversely affected
2. 02our ability to establish, scale up, and scale out, either alone or with CDMOs, manufacturing capabilities for clinical supply of our product candidates for our clinical trials and, if any of our product candidates are approved, commercial supply (including licensure) of such product candidates
3. 03We may not realize the benefits of technologies that we have acquired or in-licensed or will acquire or in-license in the future
4. 04challenges integrating acquired businesses into our business, including our existing operations and culture
5. 05We may fail to enter into new strategic relationships or may not realize the benefits of any strategic relationships that we have entered into, either of which could materially adversely affect our business, financial condition, commercialization prospects, and results of operations
6. 06we may not achieve the revenue, specific net income, or other anticipated benefits that justify our having entered into, or otherwise led us to enter into, the collaboration
7. 07Our ability to develop our cell engineering platforms and product candidates and our future growth depend on retaining our key personnel and recruiting additional qualified personnel
8. 08We may encounter difficulties in managing our growth if and as we expand our operations, including our development and regulatory capabilities, which could disrupt our operations and otherwise harm our business
9. 09We 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

Risks Related to the Development and Clinical Testing of Our Product Candidates

1. 10Preclinical testing of our product candidates may be delayed or otherwise unsuccessful, which would harm our ability to commence and successfully complete clinical trials of, and ultimately commercialize, such product candidates
2. 11feedback from the FDA or comparable foreign regulatory authorities that requires us to conduct additional testing or change the design of a planned clinical trial prior to submitting such IND or comparable foreign submission
3. 12business interruptions resulting from geo-political actions, including war and terrorism, natural disasters including earthquakes, typhoons, floods, and fires, or disease
4. 13Any of these events could prevent us or our potential future partners from achieving or maintaining market acceptance of the affected product or could substantially increase commercialization costs and expenses, which in turn could delay or prevent us from generating significant revenue from the sale of any products
5. 14Our product candidates or technologies may be involved in investigator-sponsored clinical trials, and we will have limited or no control over the conduct of such trials
6. 15The manufacture of our product candidates is complex. We or our CDMOs may encounter difficulties in production, which could delay or entirely halt our or their ability to supply our product candidates for clinical trials or, if approved, for commercial sale
7. 16We are exposed to a number of risks related to the supply chain for the materials required to manufacture our product candidates
8. 17We may become exposed to costly and damaging liability claims, either when testing our product candidates in clinical trials or at the commercial stage, and our product liability insurance may not cover all damages arising from such claims

Risks Related to Intellectual Property and Information Technology

1. 18Our success depends on our ability to protect our intellectual property rights and proprietary technologies, and we may not be able to protect our intellectual property rights throughout the world
2. 19the allocation of ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and by us and our partners
3. 20We depend, in part, on our licensors to file, prosecute, maintain, defend, and enforce certain patents and patent applications that are material to our business
4. 21We may depend on intellectual property licensed or sublicensed to us from, or for which development was funded or otherwise assisted by, government agencies, such as the National Institutes of Health, for development of our technology and product candidates
5. 22whether we will need to initiate litigation or administrative proceedings to defend our patent rights, which may be costly whether we win or lose
6. 23We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope, or expiration of a third-party patent, which might adversely affect our ability to develop and market our products
7. 24Intellectual property rights do not necessarily protect us from all potential threats to our competitive advantage
8. 25Confidentiality agreements with employees and third parties may not prevent disclosure of trade secrets and other proprietary information
9. 26Third-party claims of intellectual property infringement against us or our collaborators may prevent or delay our product discovery, development, or commercialization efforts
10. 27The terms of our patents may not be sufficient to effectively protect our products and business
11. 28Third parties may challenge the inventorship or ownership of or otherwise assert rights in our patent and other intellectual property rights
12. 29We may be subject to claims that our employees, consultants, or independent contractors have wrongfully used or disclosed confidential information of third parties
13. 30Our internal computer systems, or those used by third parties involved in our operations, such as research institution collaborators, CROs, CDMOs, and other service providers, contractors, or consultants, may fail or suffer security breaches or incidents
14. 31If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected
15. 32Changes in United States and foreign patent law could diminish the value of patents in general, thereby impairing our ability to protect our products
16. 33Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment, and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for noncompliance with these requirements

Risks Related to Our Regulatory Environment

1. 34the approval policies or regulations of the FDA or comparable foreign regulatory authorities may change in a manner that renders our clinical data insufficient for approval, including, for example, as a result of positive or negative data from third parties regarding other products or product candidates
2. 35The occurrence of any of these events could harm our business, possibly materially
3. 36impose regulatory sanctions, seize or detain products, refuse to permit the import or export of products, or require us to conduct a product recall or remove the product from the market
4. 37similar healthcare laws and regulations in foreign jurisdictions, including reporting requirements detailing interactions with and payments to healthcare providers
5. 38Our employees, independent contractors, principal investigators, consultants, vendors, commercial partners, and other third parties that we engage or with which we collaborate may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements
6. 39Current and future legislation may increase the difficulty and cost for us and any future collaborators to obtain marketing approval of and commercialize our product candidates and affect the prices we, or they, may charge for such product candidates
7. 40a licensure framework for follow-on biologic products
8. 41Even if we are able to commercialize any product candidate, coverage and adequate reimbursement may not be available or such product candidate may become subject to unfavorable pricing regulations or third-party coverage and reimbursement policies, which would harm our business
9. 42the availability of capital

Risks Related to Our Limited Operating History, Financial Condition, and Need for Additional Capital

1. 43We will require additional funding to finance our operations. If we are unable to raise capital when needed, or on acceptable terms, we could be forced to delay, reduce, or eliminate certain product development programs or commercialization efforts
2. 44the extent to which we acquire or invest in businesses, products, and technologies
3. 45Raising additional capital may cause dilution to our stockholders, restrict our operations, or require us to relinquish rights to our technologies or product candidates
4. 46We have incurred significant losses since our inception, and we expect to incur losses for the foreseeable future. We have no products approved for commercial sale and may never achieve or maintain profitability
5. 47continue to incur legal, accounting, and other expenses to operate our business, including the costs associated with operating as a public company
6. 48Our success payment and contingent consideration obligations in our license and acquisition agreements may result in dilution to our stockholders, drain our cash resources, or require us to incur debt to satisfy the payment obligations
7. 49Our limited operating history may make it difficult to evaluate our prospects and likelihood of success

Risks Related to Commercialization of Our Product Candidates

1. 50We operate in highly competitive and rapidly changing industries, which may result in others discovering, developing, or commercializing competing products before or more successfully than we do
2. 51Our business, financial condition, and results of operations could be materially adversely affected by any of the foregoing events
3. 52Market opportunity and market growth for our product candidates may prove to be smaller than we initially estimated, and even if the markets in which we compete achieve the forecasted growth, our business may not grow at similar rates or at all, or we may otherwise be unable to capitalize on this opportunity
4. 53We currently have no marketing, sales, or distribution infrastructure and we intend to either establish a sales and marketing infrastructure or outsource this function to a third party. Each of these commercialization strategies carries substantial risks to us
5. 54Our product candidates for which we intend to seek approval as biologic products may face competition sooner than anticipated

Risks Related to Ownership of Our Common Stock

1. 55Our principal stockholders and management own a significant percentage of our stock and will be able to exert significant control over matters subject to stockholder approval
2. 56Future sales of our securities by us in the public market could cause our common stock price to fall
3. 57Sales of a substantial number of shares of our common stock by our existing stockholders in the public market, or the perception that such sales could occur, could cause our stock price to fall
4. 58We do not currently intend to pay dividends on our common stock and, consequently, our stockholders’ ability to achieve a return on their investment will depend on appreciation of the value of our common stock
5. 59Provisions in our amended and restated certificate of incorporation and our amended and restated bylaws and Delaware law might discourage, delay, or prevent a change in control of our company or changes in our management and, therefore, depress the market price of our common stock
6. 60limit the jurisdictions in which certain stockholder litigation may be brought
7. 61Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited
8. 62Changes in U.S. and foreign tax laws could have a material adverse effect on our business, cash flow, results of operations, or financial conditions
9. 63Our quarterly operating results may fluctuate significantly or may fall below the expectations of investors or securities analysts, each of which may cause our stock price to fluctuate or decline
10. 64changes in general market and economic conditions
11. 65Our stock price may be volatile or may decline regardless of our operating performance, which may result in substantial losses for investors and may potentially subject us to securities class action litigation, which is expensive and could divert management’s attention
12. 66other events or factors, many of which are beyond our control
13. 67Market and economic conditions may negatively impact our business, financial condition, and share price
14. 68We are an emerging growth company, and any decision on our part to comply only with certain reduced reporting and disclosure requirements applicable to emerging growth companies could make our common stock less attractive to investors
15. 69exemptions from the requirements of holding non-binding advisory votes on executive compensation and stockholder approval of any golden parachute payments not previously approved
16. 70the last day of the fiscal year ending after the fifth anniversary of the completion of our IPO, which is December 31, 2026
17. 71The requirements of being a public company may strain our resources, result in an increased risk of litigation, and divert management’s attention
18. 72If we fail to maintain proper and effective internal controls over financial reporting, our ability to produce accurate and timely financial statements could be impaired
19. 73Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud