CRISPR Therapeutics (CRSP) risk factors, FY2025 10-K

Risks Related to Our Financial Position and Need for Additional Capital

1. 01We Have Incurred Significant Operating Losses Since Our Inception And Anticipate That We Will Incur Continued Losses For The Foreseeable Future
2. 02establish a sales, marketing, and distribution infrastructure to commercialize any products for which we, or our partners and collaborators, may obtain or have obtained marketing approval25% rewritten
3. 03We Will Need To Raise Substantial Additional Funding, Which Will Dilute Our Shareholders. If We Are Unable To Raise Capital When Needed, We Would Be Forced To Delay, Reduce Or Eliminate Some Of Our Product Development Programs Or Commercialization Efforts22% rewritten
4. 04our ability to establish and maintain healthcare coverage and adequate reimbursement21% rewritten
5. 05If we are unable to obtain funding on a timely basis, we may be required to significantly curtail, delay or discontinue one orNew
6. 06We Have A Limited Operating History, Which May Make It Difficult To Evaluate Our Technology And Product Development Capabilities And Predict Our Future Performance
7. 07Our Ability To Use Tax Loss Carryforwards In Switzerland May Be Limited

Risks Related to Our Business, Technology and Industry

1. 08If We Are Unable To Advance Our Product Candidates To Clinical Development, Obtain Regulatory Approval And Ultimately Commercialize Our Product Candidates, Or Experience Significant Delays In Doing So, Our Business Will Be Materially Harmed73% rewritten
2. 09achieving desirable medicinal properties for the intended indications
3. 10the FDA recommends a follow-up observation period of up to 15 years for all patients who receive treatment using gene therapies, and we may need to adopt and support, and have adopted and are supporting for certain of our trials, such an observation period for our product candidates94% rewritten
4. 11Similarly, relatively few siRNA product candidates have been tested in humans and to date few have received regulatory approval and market authorizationsNew
5. 12Our Engineered Allogeneic T cell Product Candidates Represent A Novel Approach To Autoimmune and Cancer Treatment That Creates Significant Challenges For Us
6. 13If significant GvHD or other adverse events are observed with the administration of our product candidates, or if any of the product candidates are viewed as less safe or effective than autologous therapies or other allogenic therapies, our ability to develop allogeneic therapies may be adversely affected
7. 14If Any Of The Product Candidates We May Develop Or Administration Processes And Delivery Modalities We Rely On Cause Undesirable Side Effects, It Could Delay Or Prevent Their Regulatory Approval, Limit The Commercial Potential Or Result In Significant Negative Consequences Following Any Potential Marketing Approval90% rewritten
8. 15another important gene or genomic elementNew
9. 16our reputation may suffer
10. 17If We Experience Delays Or Difficulties In The Enrollment Of Patients In Clinical Trials, Our Receipt Of Necessary Regulatory Approvals Could Be Delayed Or Prevented
11. 18proximity and availability of clinical trial sites for prospective patients
12. 19We May Never Obtain FDA Approval For Any Of Our Wholly-Owned Product Candidates In The United States, And Even If We Do, We May Never Obtain Approval For Or Commercialize Any Of Our Wholly-Owned Product Candidates In Any Other Jurisdiction, Which Would Limit Our Ability To Realize Their Full Market Potential59% rewritten
13. 20We May Seek Designation For Our Platform Technology As A Designated Platform Technology, But We Might Not Receive Such Designation, And Even If We Do, Such Designation May Not Lead To A Faster Regulatory Review Or Approval Process
14. 21There is no assurance that we will be able to obtain orphan drug designation for other of our other product candidates. Orphan drug designation does not change the standards for product approval, and there is no assurance that such designation will result in expedited review or approval26% rewritten
15. 22Competition Sooner Than AnticipatedNew
16. 23While We May Seek Accelerated Approval For Some Of Our Product Candidates, We May Not Be Able To Obtain It As The Sufficiency Of Our Clinical Trial Results For Accelerated Approval Are Subject To The FDA’s Discretion
17. 24Adverse Public Perception Of Gene Editing And Cellular Therapy Products May Negatively Impact Demand For, Or Regulatory Approval Of, Our Product Candidates42% rewritten
18. 25candidates we may develop in lieu of, or in addition to, existing treatments with which they are already familiar and for which greater clinical data may be availableNew
19. 26If We Are Unable To Establish Sales And Marketing Capabilities Or Enter Into Agreements With Third Parties To Sell And Market Products Based On Our Technologies, We May Not Be Successful In Commercializing Our Products If And When Any Products Candidates Are Approved And We May Not Be Able To Generate Any Revenue
20. 27unforeseen costs and expenses associated with creating an independent sales and marketing organization
21. 28needed, the sponsor of the BLA, must submit a proposed REMS before it can obtain approval. A REMS could include medication guides, physician communication plans, or elements to assure safe use, such as restricted distribution methods, patient registries and other risk minimization toolsNew
22. 29injunctions or the imposition of civil or criminal penalties44% rewritten
23. 30Any government investigation of alleged violations of law, including investigations of any of our vendors, could require us toNew
24. 31The Commercial Success Of Any Of Our Products or Product Candidates Will Depend Upon Its Degree Of Market Acceptance By Healthcare Providers, Patients, Third-party Payors And Others In The Medical Community
25. 32approval of new products or technologies that are more favorably received than our products, are more cost effective or render our products obsolete
26. 33We Face Significant Competition In The Biotechnology And Pharmaceutical Industries
27. 34Even If We Are Able To Commercialize Any Product Candidates, Such Products May Become Subject To Unfavorable Pricing Regulations, Third-party Reimbursement Practices, Or Healthcare Reform Initiatives, Which Would Harm Our Business

Risks Related to Our Relationships with Third Parties

1. 35We Have Partnered With Vertex On Our Lead Program CASGEVY; Vertex Has Significant Control Over The CASGEVY Program82% rewritten
2. 36under the Amended A&R Vertex JDCA. This could cause delays or difficulties in the development and commercialization of certain product candidates, including CASGEVY, and have a material adverse effect on our business, financial condition, results of operations, and prospectsNew
3. 37CASGEVY For SCD Has Received A Commissioner’s National Priority Voucher. The Benefits Of Such A Voucher, Including A Potentially Accelerated Timeline For Review Of Any [sBLA] Submission For CASGEVY For SCD By The FDA, May Not Be Able To Be Fully RealizedNew
4. 38Our Collaborators And Strategic Partners May Control Aspects Of Our Clinical Trials and Commercialization Efforts, Which Could Result In Delays And Other Obstacles In The Commercialization Of Our Proposed Products And Materially Harm Our Results Of Operations51% rewritten
5. 39If Conflicts Arise Between Us And Our Collaborators Or Strategic Partners, These Parties May Act In A Manner Adverse To Us And Could Limit Our Ability To Implement Our Strategies39% rewritten
6. 40In addition, current or future collaborators or strategic partners could also become our competitors in the future. OurNew
7. 41Our Collaborators Or Strategic Partners May Decide To Adopt Alternative Technologies Or May Be Unable To Develop Commercially Viable Products With Our Technology, Which Would Negatively Impact Our Financial Results And Our Strategy To Develop These Products
8. 42We May Seek To Establish Additional Collaborations And, If We Are Not Able To Establish Them On Commercially Reasonable Terms, We May Have To Alter Our Development And Commercialization Plans95% rewritten
9. 43Our Product Candidates And Our Business Could Be Substantially HarmedNew
10. 44form relationships with other entities, some of which may be our competitors59% rewritten

Risks Related to Manufacturing and Supply

1. 45Gene Editing and Gene Silencing Products Are Novel And May Be Complex And Difficult To Manufacture. We Could Experience Manufacturing Problems Or Regulatory Requirements That Result In Delays In The Development, Approval Or Commercialization Of Our Product Candidates Or Otherwise Harm Our Business
2. 46The Manufacturing Facilities For Our Product Candidates Are Subject To Rigorous Regulations And Failure To Obtain Or Maintain Regulatory Approvals Or Operate In Line With Established cGMPs And International Best Practices Could Delay Or Impair Our Ability To Commercialize Our Product Candidates24% rewritten
3. 47We Are Subject To Regulatory And Operational Risks Associated With Our Internal Manufacturing Facility41% rewritten
4. 48our third-party contract manufacturers may manufacture defective or otherwise dangerous products that could result in injury to consumers during clinical trials or once commercialized for sale to the public, if not discovered by us

Risks Related to Employee Matters, Managing Growth and Other Risks Related to Our Business

1. 49Our Future Success Depends On Our Ability To Retain Key Executives And To Attract, Retain And Motivate Qualified Personnel44% rewritten
2. 50Swiss Corporate Governance With Respect To Executive Compensation May Affect Our Business
3. 51Our 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
4. 52If 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 Harm Our Business
5. 53We Are At Risk of Product Liability And Other Product-Related Claims And Lawsuits, Which Could Cause Us To Incur Substantial Liabilities And Could Limit Commercialization Of Any Product Candidates That We May DevelopNew
6. 54the inability to commercialize any product candidates that we may develop
7. 55If We Fail To Establish And Maintain Proper And Effective Internal Control Over Financial Reporting, Our Operating Results And Our Ability To Operate Our Business Could Be Harmed
8. 56Our Business Operations Have a Substantial International Footprint and We May Further Expand In The Future, Which Presents Challenges In Managing Our Business Operations
9. 57regulations relating to data security and the unauthorized use of, or access to, commercial and personal information

Risks Related to Intellectual Property

1. 58If We Are Unable To Obtain, Maintain Or Protect Intellectual Property Rights Related to Our Proprietary Gene Editing Technology And Product Candidates, We May Not Be Able To Compete Effectively In Our Markets95% rewritten
2. 59including patent rights and trade secret protection, as well as entering into confidentiality agreements and in-licensing arrangementsNew
3. 60Issued Patents Covering Our Technology And Product Candidates Could Be Found Invalid Or Unenforceable If Challenged In Court or Before The USPTO Or Comparable Foreign Authority
4. 61Claims that we have misappropriated the confidential information or trade secrets of third parties could have a similar material adverse effect on our business, financial condition, results of operations, and prospects
5. 62Third-party Claims Of Intellectual Property Infringement Against Us, Our Licensors Or Our Collaborators May Prevent Or Delay Our Product Discovery and Development Efforts
6. 63Third-party Claims Of Overlapping Intellectual Property Rights May Prevent Or Delay Our Product Discovery and Development Efforts53% rewritten
7. 64Group may appeal the decision in 2026New
8. 65Our Rights To Develop And Commercialize Our Technology And Product Candidates Are Subject, In Part, To The Terms And Conditions Of Licenses Granted To Us By Others
9. 66The Intellectual Property That Protects Our Core Gene Editing Technology Is Jointly Owned, And Our License Is From Only One Of The Joint Owners, Materially Limiting Our Rights In The United States And In Other Jurisdictions93% rewritten
10. 67License Intellectual Property To. Any Disputes With These Parties Could Adversely Affect Our Business And We Could Lose License Rights That Are Important To Our Business
11. 68the priority of invention of patented technology
12. 69We May Not Be Successful In Obtaining Or Maintaining Necessary Rights To Any Product Candidates or Other Technologies We May Develop Through Acquisitions And In-Licenses
13. 70Intellectual Property Litigation Could Cause Us To Spend Substantial Resources And Distract Our Personnel From Their Normal Responsibilities
14. 71We May Not Be Able To Protect Our Intellectual Property And Proprietary Rights Throughout The World
15. 72Our success, like other companies in the biotech and pharmaceutical sectors, relies heavily on intellectual property, especially patents. Patent acquisition and enforcement in our industry are complex, expensive, and uncertain due to technical and legal intricacies55% rewritten
16. 73Obtaining 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 Non-Compliance With These Requirements
17. 74If We Do Not Obtain Patent Term Extension And Data Exclusivity For Any Product Candidates We May Develop, Our Business May Be Materially Harmed
18. 75Intellectual Property Rights Do Not Necessarily Address All Potential Threats
19. 76Should any of these events occur, they could have a material adverse effect on our business, financial condition, results of operations, and prospectsNew
20. 77We Regard As Our Own Intellectual PropertyNew
21. 78If We Are Unable To Protect The Confidentiality Of Our Trade Secrets And Other Proprietary Information, Our Business And Competitive Position Would Be Harmed
22. 79If Our Trademarks 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

Risks Related to The Ownership of Our Common Shares

1. 80We Have Broad Discretion In The Use Of Our Cash Reserves And May Not Use Such Cash Reserves Effectively
2. 81Sales Of A Substantial Number Of Our Common Shares In The Public Market Could Cause Our Share Price To Fall43% rewritten
3. 82We Do Not Expect To Pay Dividends In The Foreseeable Future
4. 83As A Swiss Corporation, We Are Subject To Swiss Legal Provisions That May Limit Our Flexibility To Swiftly Implement Certain Initiatives Or Strategies
5. 84Anti-takeover Provisions In Our Articles Of Association Could Make An Acquisition Of Our Company, Which May Be Beneficial To Our Shareholders, More Difficult And May Prevent Attempts By Our Shareholders To Replace Or Remove Our Current Management36% rewritten
6. 85Our Status As A Swiss Corporation May Limit Our Flexibility With Respect To Certain Aspects Of Capital Management And May Cause Us To Be Unable To Make Distributions Without Subjecting Our Shareholders To Swiss Withholding Tax
7. 86U.S. Holders Of Our Common Shares May Suffer Adverse Tax Consequences If We Are Characterized As A Passive Foreign Investment Company For Any Taxable Year
8. 87an estate, the income of which is subject to U.S. federal income taxation regardless of its source; or
9. 88U.S. Shareholders May Not Be Able To Obtain Judgments Or Enforce Civil Liabilities Against Us Or Our Executive Officers Or Members Of Our Board Of Directors
10. 89the court procedures and the service of documents leading to the judgment were in accordance with the due process of law; and

Risks Related to Information Security and Privacy

1. 90We May Fail To Comply With Evolving European And Other Privacy Laws
2. 91Artificial Intelligence Presents Risks And Challenges That Can Impact Our Business Including By Posing Cybersecurity and Other Risks To Our Confidential Information, Proprietary Information And Personal Data96% rewritten
3. 92Our Internal Information Technology Systems, Or Those Of Our Collaborators Or Other Contractors Or Consultants, May Fail Or Suffer Security Breaches, Which Could Result In A Material Disruption Of Our Product Development Programs24% rewritten

General Risks

1. 93We Incur Significant Costs As A Result Of Operating As A Public Company And Our Management Is Required To Devote Substantial Time To Compliance Initiatives And Corporate Governance Practices
2. 94The Market Price Of Our Common Shares Has Been Volatile and Fluctuate Substantially, Which Could Result In Substantial Losses For Shareholders
3. 95the other factors described in this “Risk Factors” section
4. 96Unfavorable Global Economic Conditions and Uncertain Geopolitical Environment Could Adversely Affect Our Business, Financial Condition Or Results Of Operations83% rewritten
5. 97Conditions In The Banking System And Financial Markets, Including The Failure Of Banks And Financial Institutions, Could Have An Adverse Effect On Our Operations And Financial Results39% rewritten
6. 98If Securities Analysts Do Not Publish Research Or Reports About Our Business Or If They Publish Negative Evaluations Of Our Common Shares, The Price Of Our Common Shares Could Decline
7. 99Our Business Is Subject To Economic, Political, Regulatory And Other Risks Associated With International Operations
8. 100business interruptions resulting from geo-political actions, including war and terrorism, or natural disasters including floods and fires65% rewritten
9. 101the SEC, and other U.S. government agencies or comparable foreign regulatory authorities on which our operations may rely is subject to the impacts of political events, including executive and congressional priorities, which are inherently fluid and unpredictableNew
10. 102The Increasing Use of Social Media Platforms Presents Risks And ChallengesNew