Atara Biotherapeutics (ATRA) risk factors, FY2024 10-K

Risks Related to Our Financial Results, Capital Needs, and Review of Strategic Alternatives

1. 01Our activities to review and pursue strategic alternatives may not result in a strategic transaction, and even if we do consummate a strategic transaction, there is no assurance that it will deliver the benefits we expect or enhance stockholder value
2. 02the possibility of future litigation
3. 03We have incurred substantial losses since our inception and anticipate that we will continue to incur substantial losses for the foreseeable future
4. 04We have a limited operating history, which may make it difficult to evaluate the success of our business to date and to assess our future viability
5. 05We have earned limited commercialization revenues to date. We may never achieve profitability
6. 06find suitable commercialization partners who can obtain coverage and adequate reimbursement from third parties, including government payors, set commercially viable prices, market, sell and distribute our approved products
7. 07reasonably estimate the actual amounts necessary to successfully complete the development and commercialization of our product and product candidates
8. 08the emergence of competing technologies or other adverse market developments
9. 09Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to our product candidates on terms that are unfavorable to us
10. 10Our workforce reductions may not result in anticipated savings, could result in total costs and expenses that are greater than expected and could disrupt our business
11. 11There can be no assurance that we will achieve all of the anticipated benefits of the Fujifilm Transaction and we could face unanticipated challenges

Risks Related to the Development of Our Product and Product Candidates

1. 12maintaining and growing an organization of scientists and functional experts who can develop our products and technology
2. 13If we do not achieve one or more of these factors in a timely manner or at all, we could experience significant delays or an inability to successfully develop and commercialize our product candidates, which could materially harm our business
3. 14Our business could be adversely affected by health epidemics and pandemics which may present substantial public health and economic challenges around the world
4. 15Our future success is dependent on the marketing authorization of our product candidates
5. 16changes in the approval policies or regulations that render our preclinical and clinical data insufficient for approval or in positions, guidance or feedback communicated by the FDA or comparable foreign regulatory authorities that have a negative impact on the potential approval of a product candidate
6. 17Our T-cell immunotherapy product and product candidates represent new therapeutic approaches that could result in heightened regulatory scrutiny, delays in clinical development or our inability to achieve regulatory approval, commercialize or secure payor coverage of our product candidates
7. 18developing therapies for types of diseases beyond those initially addressed by our current product and product candidates
8. 19The results of preclinical studies or earlier clinical studies are not necessarily predictive of future results. Our existing product candidate in clinical studies, and any other product candidate we advance into clinical studies, may not have favorable results in later clinical studies or receive regulatory approval
9. 20Interim “top line” and preliminary data from clinical studies that we or our partners may announce or share with regulatory authorities 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
10. 21Clinical drug development involves a lengthy and expensive process with an uncertain outcome
11. 22data that demonstrate an unacceptable benefit/risk profile, including a lack of efficacy, unforeseen safety issues or adverse side effects
12. 23changes in governmental regulations or administrative actions or lack of adequate funding to continue a clinical study
13. 24disruptions caused by man-made or natural disasters or public health pandemics or epidemics, including, for example, the COVID-19 pandemic
14. 25our reputation may suffer
15. 26The market opportunities for our product and product candidates may be limited to those patients who are ineligible for or have failed prior treatments and may be small
16. 27We may not be able to obtain or maintain orphan drug exclusivity for our product candidates
17. 28BTD by the FDA and PRIME designation by the EMA may not lead to a faster development or regulatory review or approval process and it does not increase the likelihood that our product candidates will receive marketing approval
18. 29A Fast Track designation by the FDA may not lead to a faster development or regulatory review, licensure process and does not increase the likelihood that our product candidates will receive marketing licensure
19. 30Failure to obtain regulatory or payor approval in international jurisdictions would prevent our product candidates from being marketed abroad
20. 31The proposed revision of the European legislation on pharmaceuticals, changes in governmental administration or changes in leadership at relevant agencies could lead to uncertainties over the regulatory framework that will be applicable to medicinal products in the EU and US, including orphan medicinal products
21. 32Even if our product candidates receive regulatory approval, they may still face future development and regulatory difficulties
22. 33The occurrence of any event or penalty described above may also generate negative publicity or inhibit our ability to successfully commercialize our products
23. 34Changes to regulations, guidelines and recommendations published by various government agencies and organizations may affect the use of our product candidates
24. 35We may not successfully identify, acquire, develop or commercialize new potential product candidates

Risks Related to Manufacturing

1. 36We are subject to a multitude of manufacturing risks, any of which could substantially increase our costs and limit supply of our product and product candidates
2. 37Delays in receiving regulatory approvals for product candidates produced at our CMOs’ facilities could delay our development plans and thereby limit our ability to generate revenues
3. 38achieving and maintaining ongoing compliance with cGMP regulations and other requirements of the FDA, EMA or other comparable regulatory agencies
4. 39If one or more of our CMO’s facilities is damaged or destroyed or production at these facilities is otherwise interrupted, our business would be negatively affected

Risks Related to Our Dependence on Third Parties

1. 40Maintaining clinical and commercial timelines is dependent on our end-to-end supply chain network to support manufacturing; if we experience problems with our third party suppliers or CMOs, we may delay development and/or commercialization of our product and product candidates
2. 41If we or our CMOs are not able to successfully transfer and produce comparable product and product candidates, our ability to further develop and manufacture our product and product candidates may be negatively impacted
3. 42depend on, among other things, the efforts, allocation of resources, negotiation of pricing and reimbursement and successful commercialization of tab-cel by Pierre Fabre
4. 43We may not realize the benefits of strategic alliances that we may form in the future or of potential future product acquisitions or licenses

Risks Related to Our Intellectual Property

1. 44If we are unable to obtain and maintain sufficient intellectual property protection for our product candidates, or if the scope of the intellectual property protection is not sufficiently broad, our ability to commercialize our product candidates successfully and to compete effectively may be adversely affected
2. 45If we are sued for infringing the intellectual property rights of third parties, the resulting litigation could be costly and time-consuming and could prevent or delay our or our partners’ development and commercialization efforts
3. 46to be unrelated, which may block our efforts or potentially result in any of our product, product candidates or our activities infringing their claims
4. 47We may face claims that we misappropriated the confidential information or trade secrets of a third party. If we are found to have misappropriated a third party’s trade secrets, we may be prevented from further using these trade secrets, which could limit our ability to develop our product candidates
5. 48We may not be able to protect our intellectual property rights throughout the world
6. 49We have in-licensed a significant portion of our intellectual property from our partners. If we breach any of our license agreements with these partners, we could lose the ability to continue the development and potential commercialization of one or more of our product candidates
7. 50We may become involved in lawsuits to protect or enforce our intellectual property, which could be expensive, time-consuming and unsuccessful and have a material adverse effect on the success of our business
8. 51If we are unable to protect the confidentiality of our trade secrets and other proprietary information, the value of our technology could be materially adversely affected and our business could be harmed

Risks Related to Commercialization of Our Product and Product Candidates

1. 52Our commercial success depends upon developing a clearly differentiated product and attaining significant market acceptance of our product and product candidates, if approved, among physicians, patients, healthcare payors and the medical community, including hospitals and outpatient clinics
2. 53Our ability to commercialize any product successfully will depend, in part, on the extent to which coverage and adequate reimbursement for these products and related treatments will be available from government health administration authorities, private health insurers and other organizations
3. 54Current and future legislation, including potentially unfavorable pricing regulations or other healthcare reform initiatives, may increase the difficulty and cost for us to obtain regulatory approval of our product candidates and affect the prices for our product and product candidates
4. 55able to charge for our future products or the amounts of reimbursement available for our future products from governmental agencies or third-party payors
5. 56Price controls may be imposed in foreign markets, which may adversely affect our future profitability
6. 57We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do
7. 58We are subject to certain contractual obligations under our royalty financing agreement with HealthCare Royalty Partners and may be subject to claims for damages if we fail to fulfill these obligations
8. 59We expect the product candidates we develop will be regulated as biological products (biologics) and therefore they may be subject to competition sooner than anticipated
9. 60If we are unable to enter into agreements with third parties to market and sell our product and product candidates, we may be unable to generate any revenue from the sale of our products
10. 61We may encounter difficulties in managing our growth, including with respect to our employee base, and managing our operations successfully
11. 62expanding our facilities

Risks Related to Ownership of Our Common Stock

1. 63Our stock price has been and will likely continue to be volatile and may decline regardless of our operating performance
2. 64the other risks described in this “Risk Factors” section
3. 65Our principal stockholders own a significant percentage of our stock and will be able to exert significant control or significant influence over matters subject to stockholder approval
4. 66Sales of a substantial number of shares of our common stock in the public market could cause our stock price to fall
5. 67We have incurred and will continue to incur increased costs as a result of being a public company and our management expects to devote substantial time to public company compliance programs
6. 68Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be the sole source of potential gain for our stockholders
7. 69Future sales and issuances of our common stock or rights to purchase common stock, including pursuant to our equity incentive plans, could result in additional dilution of the percentage ownership of our stockholders and could cause our stock price to fall
8. 70Some terms of our charter documents and Delaware law may have anti-takeover effects that could discourage an acquisition of us by others, even if an acquisition would be beneficial to our stockholders and may prevent attempts by our stockholders to replace or remove our current management
9. 71Any of the factors listed above may frustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace members of our board of directors, who are responsible for appointing the members of our management
10. 72We qualify as a “smaller reporting company” and a “non-accelerated filer,” and any decision on our part to comply only with certain reduced reporting and disclosure requirements applicable to such companies could make our common shares less attractive to investors
11. 73If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our stock price and trading volume could decline
12. 74Our future success depends on our ability to retain our executive officers and to attract, retain and motivate qualified personnel
13. 75Our relationships with customers and third party payors will be subject to applicable anti-kickback, fraud and abuse, privacy and other laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings
14. 76Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could cause significant liability for us and harm our reputation
15. 77Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop
16. 78the inability to commercialize any products that we may develop
17. 79If we and our third party manufacturers 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
18. 80The actual or perceived failure by us, our customers, or vendors to comply with increasingly stringent laws, regulations and contractual obligations relating to privacy, data protection, and data security could harm our reputation, and subject us to significant fines and liability
19. 81Changes in tax laws or regulations that are applied adversely to us or our customers may have an adverse effect on our business, cash flows, financial condition or results of operations
20. 82Our ability to use net operating loss carryforwards and certain tax assets to offset future taxable income or taxes may be subject to certain limitations
21. 83Business disruptions could seriously harm our future revenues and financial condition and increase our costs and expenses
22. 84The biopharmaceutical industry is subject to extensive regulatory obligations and policies that are subject to significant and abrupt change, including due to judicial challenges, election cycles, and resulting regulatory updaters and changes in policy priorities