Crescent Biopharma (CBIO) risk factors, FY2024 10-K

Risks Related to Our Proposed Merger with Crescent

1. 01Failure to complete, or delays in completing, the potential merger, announced on October 29, 2024, could materially and adversely affect our results of operations, business, financial results and/or common stock price
2. 02If the conditions to the Merger are not satisfied or waived, the Merger may not occur
3. 03The exchange ratio for the Merger will not change or otherwise be adjusted based on the market price of GlycoMimetics common stock
4. 04If the Merger is not completed, our stock price may decline significantly
5. 05period-to-period fluctuations in financial results
6. 06Even if we complete the Merger, the combined company will need to raise additional capital by issuing equity securities or additional debt or through licensing arrangements, which may cause significant dilution to the combined company’s stockholders or restrict the combined company’s operations
7. 07Some of our directors and executive officers have interests in the Merger that are different from yours and that may influence them to support or approve the Merger without regard to your interests
8. 08include, among others, retention bonus payments, extension of exercisability periods of previously issued stock option grants, severance payments if employment is terminated in a qualifying termination in connection with the Merger and rights to continued indemnification, expense advancement and insurance coverage
9. 09Certain provisions of the Merger Agreement may discourage third parties from submitting competing proposals, including proposals that may be superior to the transactions contemplated by the Merger Agreement
10. 10Our stockholders will experience significant dilution as a consequence of the Merger and related transactions
11. 11The consummation of our proposed Merger with Crescent will require significant time on the part of the Company, and the diversion of the Company’s attention may disrupt our business
12. 12We may become involved in litigation, including securities class action litigation, that could divert management’s attention and harm our business, and insurance coverage may not be sufficient to cover all costs and damages
13. 13Our common stock was previously listed on the Nasdaq Global Market, and we were required to meet certain listing requirements, including with respect to minimum closing bid prices, market value of publicly held shares, stockholders’ equity and market value of listed securities
14. 14granted an additional 180 calendar days, or until June 16, 2025, to regain compliance with the minimum closing bid price requirement for continued listing on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2)

Risks Related to Our Financial Position and Capital Needs

1. 15We have incurred significant losses since our inception. We expect to continue to incur losses and may never achieve or maintain profitability
2. 16We have incurred significant losses since our inception and, as of December 31, 2024, we had an accumulated deficit of $494.4 million. In recent years, we have financed our operations primarily with proceeds from public offerings of our common stock
3. 17We expect to continue to incur significant expenses in connection with our ongoing activities, including continuing to operate as a public company. If we were to resume clinical development activities in the future, we would expect to incur significant additional expenses and operating losses
4. 18Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our drug candidates

Risks Related to the Discovery and Development of Our Drug Candidates

1. 19Should we resume development of our drug candidates, our focus on discovering and developing novel glycomimetic drugs and our approach to discovering and developing drugs may never lead to marketable drugs
2. 20If we were to resume development activities, we would need to conduct additional clinical trials. All of our other drug candidates other than uproleselan were in earlier stages of clinical trials or in preclinical development
3. 21Clinical drug development involves a lengthy and expensive process, with an uncertain outcome. Should we resume development of our drug candidates, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our drug candidates
4. 22Should we resume development of our drug candidates, serious adverse or unacceptable side effects could be identified, in which case we would need to abandon or limit their development
5. 23If we were to resume development of our drug candidates, we may expend our limited resources to pursue a particular drug candidate or indication and fail to capitalize on drug candidates or indications that may be more profitable or for which there is a greater likelihood of success

Risks Related to Our Dependence on Third Parties

1. 24Should we resume development activities, our success would depend in part on collaborations. If we are unable to maintain any of these collaborations, or if these collaborations are not successful, our business could be adversely affected
2. 25Should we resume development of our drug candidates, we would expect to rely on third parties to conduct additional clinical trials for our drug candidates, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials

Risks Related to the Potential Commercialization of Drug Candidates

1. 26Should we resume development of drug candidates, if any of those drug candidates were to receive marketing approval, it may still fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success
2. 27Should we resume development of our drug candidates, we would need to establish sales, marketing and distribution capabilities for our drug candidates and may not be successful in commercializing those drug candidates if approved
3. 28Even if we were to resume drug development, we would face substantial competition, which may result in others discovering, developing or commercializing drugs before or more successfully than we do
4. 29Even if we or our collaborators are able to commercialize any of our drug candidates, the drugs may become subject to unfavorable pricing regulations or third-party coverage and reimbursement policies
5. 30Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any drugs that we may develop

Risks Related to Our Intellectual Property

1. 31We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time consuming and unsuccessful
2. 32We may need to license intellectual property from third parties, and such licenses may not be available or may not be available on commercially reasonable terms
3. 33Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on the success of our business
4. 34We may be subject to claims by third parties asserting that we or our employees have misappropriated their intellectual property, or claiming ownership of what we regard as our own intellectual property
5. 35Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities
6. 36If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed

Risks Related to Regulatory Approval of Our Drug Candidates and Other Legal Compliance Matters

1. 37Should we resume development of our drug candidates but we or our collaborators are not able to obtain, or if there are delays in obtaining, required regulatory approvals, we or they would not be able to commercialize our drug candidates and our ability to generate revenue would be materially impaired
2. 38Even though we previously obtained Orphan Drug designation for several of our drug candidates, we may not be able to obtain orphan drug marketing exclusivity for these or any of our other drug candidates should we resume their development
3. 39Even if we were to resume the development of uproleselan, the FDA fast track designation and additional breakthrough therapy designation for uproleselan may not actually lead to a faster development or regulatory review or approval process
4. 40Failure to obtain marketing approval in international jurisdictions would prevent our drug candidates from being marketed abroad
5. 41Should we resume drug development activities, a variety of risks associated with developing and marketing our drug candidates internationally could hurt our business
6. 42Even if we were to resume drug development activities, recently enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our drug candidates and affect the prices we may obtain
7. 43Governments outside the United States tend to impose strict price controls, which may adversely affect our revenue, if any, from the potential commercialization of drug candidates
8. 44If 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
9. 45Our employees and employees of our collaborators may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements
10. 46Unfavorable global economic conditions could adversely affect our business, financial condition or results of operations
11. 47If we fail to comply or regain compliance with Nasdaq’s continued listing standards prior to the consummation of the Merger, our common stock may be delisted and the price of our common stock, our ability to access the capital markets and our financial condition could be negatively impacted
12. 48An active trading market for our common stock may not be sustained
13. 49The trading price of our common stock has been and is likely to continue to be volatile
14. 50If 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
15. 51The issuance of additional stock in connection with financings, acquisitions, investments, our stock incentive plan, our employee stock purchase plan or otherwise will dilute all other stockholders
16. 52If a substantial number of our total outstanding shares are sold into the market, or if the market perceives that such sales may occur, it could cause the market price of our common stock to drop significantly
17. 53Provisions in our corporate charter documents and under Delaware law may prevent or frustrate attempts by our stockholders to change our management and hinder efforts to acquire a controlling interest in us, and the market price of our common stock may be lower as a result
18. 54If we fail to maintain proper and effective internal controls, our ability to produce accurate financial statements on a timely basis could be impaired
19. 55We do not anticipate paying any cash dividends on our common stock, and our stock may not appreciate in value
20. 56Our ability to use net operating loss carryforwards may be subject to limitations