CRISPR Therapeutics (CRSP) risk factors, FY2024 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 approval
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 Efforts
4. 04our ability to establish and maintain healthcare coverage and adequate reimbursement
5. 05We Have A Limited Operating History, Which May Make It Difficult To Evaluate Our Technology And Product Development Capabilities And Predict Our Future Performance
6. 06Our Ability To Use Tax Loss Carryforwards In Switzerland May Be Limited

Risks Related to Our Business, Technology and Industry

1. 07If 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 Harmed
2. 08product and we may never be able to again research, develop or commercialize a marketable product
3. 09achieving desirable medicinal properties for the intended indications
4. 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 candidates
5. 11Our Engineered Allogeneic T cell Product Candidates Represent A Novel Approach To Cancer Treatment That Creates Significant Challenges For Us
6. 12If 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. 13If 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 Approval
8. 14our reputation may suffer
9. 15If We Experience Delays Or Difficulties In The Enrollment Of Patients In Clinical Trials, Our Receipt Of Necessary Regulatory Approvals Could Be Delayed Or Prevented
10. 16proximity and availability of clinical trial sites for prospective patients
11. 17We 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 Potential
12. 18product candidates no longer meet the conditions for qualification or decide that the time period for FDA review or approval will not be shortened
13. 19We 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. 20There 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 approval
15. 21We Expect The Product Candidates We Develop Will Be Regulated Biologics And Therefore They May Be Subject To Competition Sooner Than Anticipated
16. 22While 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. 23Adverse Public Perception Of Gene Editing And Cellular Therapy Products May Negatively Impact Demand For, Or Regulatory Approval Of, Our Product Candidates
18. 24If 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
19. 25unforeseen costs and expenses associated with creating an independent sales and marketing organization
20. 26Accordingly, assuming we, or any collaborators we may have, receive marketing approval for one or more product candidates
21. 27injunctions or the imposition of civil or criminal penalties
22. 28The 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
23. 29approval of new products or technologies that are more favorably received than our products, are more cost effective or render our products obsolete
24. 30We Face Significant Competition In The Biotechnology And Pharmaceutical Industries
25. 31Even 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. 32We Have Partnered With Vertex On Our Lead Program CASGEVY; Vertex Has Significant Control Over The CASGEVY Program
2. 33Our 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 Operations
3. 34arrangement or result in litigation or arbitration, which would be time-consuming and expensive. If one of our collaborators terminates its agreement with us, we may find it more difficult to attract new collaborators and our perception in the business and financial communities could be adversely affected
4. 35If 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 Strategies
5. 36Our 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
6. 37We 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 Plans
7. 38pharmaceutical and biotechnology companies for the development and potential commercialization of those product candidates
8. 39form relationships with other entities, some of which may be our competitors
9. 40Efforts to ensure that our business arrangements with third parties will comply with applicable healthcare laws and regulations

Risks Related to Manufacturing and Supply

1. 41Gene Editing 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. 42The 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 Candidates
3. 43We Are Subject To Regulatory And Operational Risks Associated With Our Internal Manufacturing Facility
4. 44which in each case, would significantly impact our ability to develop, obtain regulatory approval for or market our product candidates, if approved
5. 45our 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. 46Our Future Success Depends On Our Ability To Retain Key Executives And To Attract, Retain And Motivate Qualified Personnel
2. 47and commercialization objectives and seriously harm our ability to successfully implement our business strategy. If we are unable to retain high quality personnel, our ability to pursue our growth strategy will be limited
3. 48Swiss Corporate Governance With Respect To Executive Compensation May Affect Our Business
4. 49Our 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
5. 50If 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
6. 51We will face an inherent risk of product liability exposure related to the testing of our product candidates in human clinical trials
7. 52the inability to commercialize any product candidates that we may develop
8. 53If 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
9. 54Our Business Operations Have a Substantial International Footprint and We May Further Expand In The Future, Which Presents Challenges In Managing Our Business Operations
10. 55regulations relating to data security and the unauthorized use of, or access to, commercial and personal information

Risks Related to Intellectual Property

1. 56If 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 Markets
2. 57Issued 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
3. 58Claims 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
4. 59Third-party Claims Of Intellectual Property Infringement Against Us, Our Licensors Or Our Collaborators May Prevent Or Delay Our Product Discovery and Development Efforts
5. 60Third-party Claims Of Overlapping Intellectual Property Rights May Prevent Or Delay Our Product Discovery and Development Efforts
6. 61Our 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
7. 62The 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 Jurisdictions
8. 63We May Experience Disputes With The Third Parties That We In-license Intellectual Property Rights From Or Those We License 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
9. 64the priority of invention of patented technology
10. 65We 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
11. 66Intellectual Property Litigation Could Cause Us To Spend Substantial Resources And Distract Our Personnel From Their Normal Responsibilities
12. 67We May Not Be Able To Protect Our Intellectual Property And Proprietary Rights Throughout The World
13. 68Our 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 intricacies
14. 69patent owners' rights, creating uncertainty about patent validity and enforceability. These changes, along with potential future legal developments, could weaken our ability to secure new patents or enforce existing ones
15. 70Obtaining 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
16. 71If We Do Not Obtain Patent Term Extension And Data Exclusivity For Any Product Candidates We May Develop, Our Business May Be Materially Harmed
17. 72Intellectual Property Rights Do Not Necessarily Address All Potential Threats
18. 73We May Be Subject To Claims That Our Employees, Consultants, Or Advisors Have Wrongfully Used Or Disclosed Confidential Information Of Their Current Or Former Employers Or Other Third Parties Or Claims Asserting Ownership Of What We Regard As Our Own Intellectual Property
19. 74If We Are Unable To Protect The Confidentiality Of Our Trade Secrets And Other Proprietary Information, Our Business And Competitive Position Would Be Harmed
20. 75If 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. 76We Have Broad Discretion In The Use Of Our Cash Reserves And May Not Use Such Cash Reserves Effectively
2. 77Sales Of A Substantial Number Of Our Common Shares In The Public Market Could Cause Our Share Price To Fall
3. 78We Do Not Expect To Pay Dividends In The Foreseeable Future
4. 79As A Swiss Corporation, We Are Subject To Swiss Legal Provisions That May Limit Our Flexibility To Swiftly Implement Certain Initiatives Or Strategies
5. 80Anti-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 Management
6. 81represented at a shareholders’ meeting
7. 82Our 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
8. 83U.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
9. 84an estate, the income of which is subject to U.S. federal income taxation regardless of its source; or
10. 85U.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
11. 86the 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. 87We May Fail To Comply With Evolving European And Other Privacy Laws
2. 88Artificial Intelligence Presents Risks And Challenges That Can Impact Our Business Including By Posing Security Risks To Our Confidential Information, Proprietary Information And Personal Data
3. 89Our 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 Programs

General Risks

1. 90We 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. 91The Market Price Of Our Common Shares Has Been Volatile and Fluctuate Substantially, Which Could Result In Substantial Losses For Shareholders
3. 92the other factors described in this “Risk Factors” section
4. 93Unfavorable Global Economic Conditions Could Adversely Affect Our Business, Financial Condition Or Results Of Operations
5. 94Our Business May Be Adversely Affected By A Pandemic, Epidemic Or Outbreak Of An Infectious Disease, Such As The Recent Coronavirus Pandemic And The Emergence of Additional Variants
6. 95Conditions 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 Results
7. 96If 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
8. 97Our Business Is Subject To Economic, Political, Regulatory And Other Risks Associated With International Operations
9. 98business interruptions resulting from geo-political actions, including war and terrorism, or natural disasters including floods and fires