What the changes say
- Post-merger Crescent Biopharma is heavily focused on advancing its lead bi-specific antibody CR-001 and ADC programs CR-002 and CR-003.
- Clinical development and partner dependencies on Paragon Therapeutics dominate the updated risk profile.
What changed since the prior 10-K
New
- NewRisks Related to Our Financial Condition and Capital Requirements
Even if successful in raising new capital, we could be limited in the amount of capital we raise due to investor demand restrictions placed on the amount of capital we raise or other reasons
Capital raising efforts for CR-001 and other programs may be restricted by investor demand limits or other constraints.
- NewRisks Related to Our Financial Condition and Capital Requirements
We have never generated any revenue from product sales and may never be profitable
The company has never generated product revenue and may never achieve profitability without successful drug commercialization.
- NewRisks Related to Our Financial Condition and Capital Requirements
for planned studies or trials, additional major studies or trials, or supportive trials necessary to support regulatory approval; and
- NewRisks Related to Discovery, Development, and Commercialization
We face competition from entities that have developed or may develop programs for the diseases addressed by product candidates developed by us
Crescent faces intense competition from established pharmaceutical giants like Merck, AstraZeneca, and Bristol Myers Squibb.
- NewRisks Related to Discovery, Development, and Commercialization
We are substantially dependent on the success of our lead program, CR-001, as well as our ADC programs, CR-002 and CR-003, and our development programs may not be successful
Operations are substantially dependent on the success of the lead program CR-001 and ADC programs CR-002 and CR-003.
- NewRisks Related to Discovery, Development, and Commercialization
If we do not achieve our projected development goals in the time frames we announce and expect, the commercialization of our product candidates may be delayed and our expenses may increase and, as a result, our share price may decline
Delays in achieving projected clinical milestones for solid tumor studies could cause the share price to decline.
- NewRisks Related to Discovery, Development, and Commercialization
Any drug delivery device that we potentially use to deliver our product candidates may have its own regulatory, development, supply and other risks
Using delivery devices like injectors for product candidates introduces technical complexity and dual FDA review risks.
- NewRisks Related to Discovery, Development, and Commercialization
Our approach to the discovery and development of our programs is unproven, and we may not be successful in our efforts to build a pipeline of programs with commercial value
The unproven scientific approach mimicking ivonescimab for CR-001 may not yield safe or effective treatments.
- NewRisks Related to Discovery, Development, and Commercialization
addition, the failure of companies that are developing products similar to us or targeting the same indications as we are to demonstrate safety and efficacy of their product candidates may be harmful to our business, financial condition, results of operations, and prospects
- NewRisks Related to Discovery, Development, and Commercialization
If we encounter difficulties enrolling patients in our future clinical trials, our clinical development activities could be delayed or otherwise adversely affected
Clinical trial progress depends on successfully recruiting and retaining sufficient patient enrollment for targeted indications.
- NewRisks Related to Discovery, Development, and Commercialization
Preliminary, “topline”, or interim data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures
Preliminary or topline clinical data announced publicly may change following final audit and verification procedures.
- NewRisks Related to Discovery, Development, and Commercialization
Any of these events could diminish the usage or otherwise limit the commercial success of our product candidates and prevent us from achieving or maintaining market acceptance of our product candidates, if approved by the FDA or other regulatory authorities
Failure to confirm clinical benefit in post-approval trials could result in the withdrawal of any FDA accelerated approvals.
- NewRisks Related to Discovery, Development, and Commercialization
Certain of our programs may compete with our other programs, which could negatively impact our business and reduce our future revenue
- NewRisks Related to Discovery, Development, and Commercialization
We intend to conduct clinical trials, initially for our CR-001 program and for future programs, at sites outside the United States, and the FDA may not accept data from trials conducted in such locations
- NewRisks Related to Discovery, Development, and Commercialization
FDA accepted such data, it could require us to modify our planned clinical trials to receive clearance to initiate such trials in the United States or to continue such trials once initiated
- NewRisks Related to Government Regulation
We may not be able to meet requirements for the chemistry, manufacturing, and control of our programs
- NewRisks Related to Government Regulation
Our product candidates for which we intend to seek approval as biologics may face competition sooner than anticipated
- NewRisks Related to Government Regulation
Current and future U.S. healthcare reform legislation or regulation may increase the difficulty and cost for us to obtain coverage for and commercialize any of our current or future product candidates and may adversely affect the prices we may set
- NewRisks Related to Government Regulation
will continue to be responsible for assessing non-clinical (e.g., economic, social, ethical) aspects of health technology, and making decisions on pricing and reimbursement
- NewRisks Related to Government Regulation
We are subject to various U.S. federal, state and foreign healthcare laws and regulations, which could increase compliance costs, and our failure to comply with these laws and regulations could harm our reputation, subject us to significant fines and liability or otherwise adversely affect our business
- NewRisks Related to Government Regulation
The successful commercialization of any of our current or future product candidates, if approved, will depend in part on the extent to which governmental authorities and health insurers establish coverage, adequate reimbursement levels and favorable pricing policies
- NewRisks Related to Our Intellectual Property
We do not currently solely own any issued patents or pending patent applications. Therefore, our ability to obtain and protect our patent rights, and protect other proprietary rights, is uncertain, exposing us to the possible loss of competitive advantage
- NewRisks Related to Our Intellectual Property
If we are unable to obtain or maintain necessary rights to our programs through acquisitions and in-licenses, our business may be materially harmed
- NewRisks Related to Our Intellectual Property
Our current collaboration with Kelun and any collaboration arrangements that we may enter into in the future may not be successful, which could adversely affect our ability to develop and commercialize our products
- NewRisks Related to Our Intellectual Property
We may be subject to patent infringement claims or may need to file claims to protect our intellectual property, which could result in substantial costs and liability and prevent us from commercializing our potential products
- NewRisks Related to Our Intellectual Property
We may be subject to claims that we have wrongfully hired an employee from a competitor or that our employees, consultants, or independent contractors have wrongfully used or disclosed confidential information of third parties
- NewRisks Related to Our Intellectual Property
Changes to patent laws in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products
- NewRisks Related to Our Intellectual Property
assurance as to the degree and range of protections any of our patents, if issued, may afford us or whether patents will be issued
- NewRisks Related to Our Intellectual Property
Obtaining and maintaining patent protection depends on compliance with various procedural, document submissions, 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
- NewRisks Related to Our Intellectual Property
We 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
- NewRisks Related to Our Intellectual Property
We may become subject to claims challenging the inventorship or ownership of our patents and other intellectual property
- NewRisks Related to Our Intellectual Property
Patent terms may be inadequate to protect the competitive position of our product candidates for an adequate amount of time
- NewRisks Related to Our Intellectual Property
The technology we currently license from Paragon and Kelun and any future technology we may license from various third parties in the future, may be subject to retained rights
- NewRisks Related to Our Intellectual Property
BPCIA litigation is complex, costly, and unpredictable, and unfavorable outcomes could result in the invalidity or unenforceability of our patents
- NewRisks Related to Our Reliance on Third Parties
We rely on third parties who operate in China, which may expose us to additional risks
- NewRisks Related to Employee Matters, Managing Growth and Other Risks Related to Our Business
In order to successfully implement our plans and strategies, we will need to grow the size of our organization and we may experience difficulties in managing this growth
- NewRisks Related to Employee Matters, Managing Growth and Other Risks Related to Our Business
We are highly dependent on our key personnel and anticipate hiring new key personnel. If we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategy
- NewRisks Related to Employee Matters, Managing Growth and Other Risks Related to Our Business
Our future growth may depend, in part, on our ability to operate in foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties
- NewRisks Related to Employee Matters, Managing Growth and Other Risks Related to Our Business
Our estimates of market opportunity and forecasts of market growth may prove to be inaccurate, and even if the markets in which we compete achieve the forecasted growth, our business may not grow at similar rates, or at all
- NewRisks Related to Employee Matters, Managing Growth and Other Risks Related to Our Business
Our employees, independent contractors, consultants, commercial collaborators, principal investigators, CROs, CMOs, suppliers, and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements
- NewRisks Related to Employee Matters, Managing Growth and Other Risks Related to Our Business
We may be subject to adverse legislative or regulatory tax changes that could negatively impact our financial condition
- NewRisks Related to Employee Matters, Managing Growth and Other Risks Related to Our Business
We may acquire businesses or products, or form strategic alliances, in the future, and may not realize the benefits of such acquisitions
- NewRisks Related to Employee Matters, Managing Growth and Other Risks Related to Our Business
We maintain our cash at financial institutions, often in balances that exceed federally-insured limits. The failure of financial institutions could adversely affect our ability to pay our operational expenses or make other payments
- NewRisks Related to Owning Our Ordinary Shares
Preferred directors elected by the holders of our Series A Preferred Shares have the ability to control or significantly influence all matters submitted to our board of directors for approval
- NewRisks Related to Owning Our Ordinary Shares
We are governed by Cayman Islands law, and certain provisions of our Articles of Association have anti-takeover implications
- NewRisks Related to Owning Our Ordinary Shares
damages, to the remedies of injunction, specific performance, or other equitable relief for any threatened or actual breach of the selection of the courts of the Cayman Islands as exclusive forum
- NewRisks Related to Owning Our Ordinary Shares
Future sales of shares by existing shareholders could cause our share price to decline
- NewRisks Related to Owning Our Ordinary Shares
We do not anticipate that we will pay any cash dividends in the foreseeable future
- NewRisks Related to Owning Our Ordinary Shares
Our executive officers, directors, and principal shareholders have the ability to control or significantly influence all matters submitted to our shareholders for approval
- NewRisks Related to Owning Our Ordinary Shares
Our ability to use Net Operating Loss (“NOL”) carryforwards and other tax attributes may be limited, including as a result of the Merger
- NewRisks Related to Owning Our Ordinary Shares
We may become exposed to costly and damaging liability claims, either when testing a product candidate in the clinic or at the commercial stage, and our product liability insurance may not cover all damages from such claims
- NewRisks Related to Owning Our Ordinary Shares
Litigation costs and the outcome of litigation could have a material adverse effect on our business
- NewRisks Related to Owning Our Ordinary Shares
Our business could be negatively impacted by sustainability or environmental, social and corporate governance (“ESG”) matters or our reporting of such matters
Dropped
- DroppedRisks Related to Our Proposed Merger with Crescent
Failure 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
Risks of delays or failure in completing the GlycoMimetics merger announced October 2024.
- DroppedRisks Related to Our Proposed Merger with Crescent
If the conditions to the Merger are not satisfied or waived, the Merger may not occur
Uncertainty surrounding the satisfaction of merger closing conditions.
- DroppedRisks Related to Our Proposed Merger with Crescent
The exchange ratio for the Merger will not change or otherwise be adjusted based on the market price of GlycoMimetics common stock
Fixed exchange ratio terms impacting combined company equity ownership percentages.
- DroppedRisks Related to Our Proposed Merger with Crescent
If the Merger is not completed, our stock price may decline significantly
Potential stock price declines if the merger was not completed.
- DroppedRisks Related to Our Proposed Merger with Crescent
period-to-period fluctuations in financial results
Broad stock market volatility and historical securities class action litigation risks.
- DroppedRisks Related to Our Proposed Merger with Crescent
Even 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
Combined company capital raising and $200 million private placement closing conditions.
- DroppedRisks Related to Our Proposed Merger with Crescent
Some 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
Director and executive officer conflicting interests regarding the merger.
- DroppedRisks Related to Our Proposed Merger with Crescent
include, 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
Retention bonuses and severance packages for executives connected to the merger.
- DroppedRisks Related to Our Proposed Merger with Crescent
Certain 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
Non-solicitation provisions restricting competing acquisition proposals.
- DroppedRisks Related to Our Proposed Merger with Crescent
Our stockholders will experience significant dilution as a consequence of the Merger and related transactions
Significant equity dilution reducing current stockholder ownership down to approximately 3%.
- DroppedRisks Related to Our Proposed Merger with Crescent
The 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
Management distraction and business disruption caused by merger integration efforts.
- DroppedRisks Related to Our Proposed Merger with Crescent
We 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
Potential securities litigation and SEC investigations following strategic transactions.
- DroppedRisks Related to Our Proposed Merger with Crescent
Our 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
- DroppedRisks Related to Our Proposed Merger with Crescent
granted 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)
- DroppedRisks Related to Our Financial Position and Capital Needs
We have incurred significant losses since our inception. We expect to continue to incur losses and may never achieve or maintain profitability
- DroppedRisks Related to Our Financial Position and Capital Needs
We 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
- DroppedRisks Related to Our Financial Position and Capital Needs
We 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
- DroppedRisks Related to the Discovery and Development of Our Drug Candidates
Should 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
- DroppedRisks Related to the Discovery and Development of Our Drug Candidates
If 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
- DroppedRisks Related to the Discovery and Development of Our Drug Candidates
Clinical 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
- DroppedRisks Related to the Discovery and Development of Our Drug Candidates
Should 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
- DroppedRisks Related to Our Dependence on Third Parties
Should 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
- DroppedRisks Related to Our Dependence on Third Parties
Should 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
- DroppedRisks Related to the Potential Commercialization of Drug Candidates
Should 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
- DroppedRisks Related to the Potential Commercialization of Drug Candidates
Should 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
- DroppedRisks Related to the Potential Commercialization of Drug Candidates
Even 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
- DroppedRisks Related to the Potential Commercialization of Drug Candidates
Even 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
- DroppedRisks Related to the Potential Commercialization of Drug Candidates
Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any drugs that we may develop
- DroppedRisks Related to Our Intellectual Property
We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time consuming and unsuccessful
- DroppedRisks Related to Our Intellectual Property
We 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
- DroppedRisks Related to Our Intellectual Property
Third 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
- DroppedRisks Related to Our Intellectual Property
We 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
- DroppedRisks Related to Our Intellectual Property
Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities
- DroppedRisks Related to Regulatory Approval of Our Drug Candidates and Other Legal Compliance Matters
Should 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
- DroppedRisks Related to Regulatory Approval of Our Drug Candidates and Other Legal Compliance Matters
Even 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
- DroppedRisks Related to Regulatory Approval of Our Drug Candidates and Other Legal Compliance Matters
Even 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
- DroppedRisks Related to Regulatory Approval of Our Drug Candidates and Other Legal Compliance Matters
Failure to obtain marketing approval in international jurisdictions would prevent our drug candidates from being marketed abroad
- DroppedRisks Related to Regulatory Approval of Our Drug Candidates and Other Legal Compliance Matters
Should we resume drug development activities, a variety of risks associated with developing and marketing our drug candidates internationally could hurt our business
- DroppedRisks Related to Regulatory Approval of Our Drug Candidates and Other Legal Compliance Matters
Even 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
- DroppedRisks Related to Regulatory Approval of Our Drug Candidates and Other Legal Compliance Matters
Our employees and employees of our collaborators may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements
- DroppedRisks Related to Regulatory Approval of Our Drug Candidates and Other Legal Compliance Matters
Unfavorable global economic conditions could adversely affect our business, financial condition or results of operations
- DroppedRisks Related to Regulatory Approval of Our Drug Candidates and Other Legal Compliance Matters
If 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
- DroppedRisks Related to Regulatory Approval of Our Drug Candidates and Other Legal Compliance Matters
An active trading market for our common stock may not be sustained
- DroppedRisks Related to Regulatory Approval of Our Drug Candidates and Other Legal Compliance Matters
The trading price of our common stock has been and is likely to continue to be volatile
- DroppedRisks Related to Regulatory Approval of Our Drug Candidates and Other Legal Compliance Matters
The 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
- DroppedRisks Related to Regulatory Approval of Our Drug Candidates and Other Legal Compliance Matters
If 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
- DroppedRisks Related to Regulatory Approval of Our Drug Candidates and Other Legal Compliance Matters
Provisions 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
- DroppedRisks Related to Regulatory Approval of Our Drug Candidates and Other Legal Compliance Matters
If we fail to maintain proper and effective internal controls, our ability to produce accurate financial statements on a timely basis could be impaired
- DroppedRisks Related to Regulatory Approval of Our Drug Candidates and Other Legal Compliance Matters
We do not anticipate paying any cash dividends on our common stock, and our stock may not appreciate in value
- DroppedRisks Related to Regulatory Approval of Our Drug Candidates and Other Legal Compliance Matters
Our ability to use net operating loss carryforwards may be subject to limitations
Reworded
- 100% rewrittenRisks Related to Our Intellectual Property
We may be unable to protect the confidentiality of our trade secrets and other proprietary information
Updated to protect specific trade secrets including product candidate sequence information, manufacturing processes, and formulation technologies rather than general carbohydrate chemistry.
Was: If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed
- 96% rewrittenRisks Related to Government Regulation
Governments outside the United States tend to impose strict price controls, which may adversely affect our revenue, if any
Refined language regarding EU member states' specific pricing, reimbursement controls, and cost containment pressures on medicinal products.
Was: Governments 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
- 94% rewrittenRisks Related to Discovery, Development, and Commercialization
We may expend our limited resources to pursue a particular program and fail to capitalize on programs that may be more profitable or for which there is a greater likelihood of success
Added specific disclosures regarding research activities conducted via Paragon Therapeutics under the September 2024 and April 2025 discovery option agreements.
Was: If 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
- 74% rewrittenRisks Related to Employee Matters, Managing Growth and Other Risks Related to Our Business
If 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 have a material adverse effect on the success of our business
Expanded hazardous materials risk to explicitly include biological and radioactive materials used in laboratory operations.
Was: If 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
- 73% rewrittenRisks Related to Our Financial Condition and Capital Requirements
Raising additional capital may cause dilution to our shareholders, restrict our operations, or require us to relinquish rights
Updated terminology from common stock and shareholders to ordinary shares following corporate restructuring.
Was: Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our drug candidates
- 63% rewrittenRisks Related to Owning Our Ordinary Shares
If equity research analysts do not publish research or reports, or publish unfavorable research or reports about us, our business or our market, our share price and trading volume could decline
Revised analyst coverage risk to reference ordinary shares instead of common stock.
Was: If 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
All 59 risk factors
Headings as the filing states them, in filing order.
Risks Related to Our Financial Condition and Capital Requirements
- 01Even if successful in raising new capital, we could be limited in the amount of capital we raise due to investor demand restrictions placed on the amount of capital we raise or other reasonsNew
- 02We have never generated any revenue from product sales and may never be profitableNew
- 03for planned studies or trials, additional major studies or trials, or supportive trials necessary to support regulatory approval; andNew
- 04Raising additional capital may cause dilution to our shareholders, restrict our operations, or require us to relinquish rights73% rewritten
Risks Related to Discovery, Development, and Commercialization
- 05We face competition from entities that have developed or may develop programs for the diseases addressed by product candidates developed by usNew
- 06We are substantially dependent on the success of our lead program, CR-001, as well as our ADC programs, CR-002 and CR-003, and our development programs may not be successfulNew
- 07If we do not achieve our projected development goals in the time frames we announce and expect, the commercialization of our product candidates may be delayed and our expenses may increase and, as a result, our share price may declineNew
- 08Any drug delivery device that we potentially use to deliver our product candidates may have its own regulatory, development, supply and other risksNew
- 09Our approach to the discovery and development of our programs is unproven, and we may not be successful in our efforts to build a pipeline of programs with commercial valueNew
- 10addition, the failure of companies that are developing products similar to us or targeting the same indications as we are to demonstrate safety and efficacy of their product candidates may be harmful to our business, financial condition, results of operations, and prospectsNew
- 11If we encounter difficulties enrolling patients in our future clinical trials, our clinical development activities could be delayed or otherwise adversely affectedNew
- 12Preliminary, “topline”, or interim data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification proceduresNew
- 13Any of these events could diminish the usage or otherwise limit the commercial success of our product candidates and prevent us from achieving or maintaining market acceptance of our product candidates, if approved by the FDA or other regulatory authoritiesNew
- 14We may expend our limited resources to pursue a particular program and fail to capitalize on programs that may be more profitable or for which there is a greater likelihood of success94% rewritten
- 15Certain of our programs may compete with our other programs, which could negatively impact our business and reduce our future revenueNew
- 16We intend to conduct clinical trials, initially for our CR-001 program and for future programs, at sites outside the United States, and the FDA may not accept data from trials conducted in such locationsNew
- 17FDA accepted such data, it could require us to modify our planned clinical trials to receive clearance to initiate such trials in the United States or to continue such trials once initiatedNew
Risks Related to Government Regulation
- 18We may not be able to meet requirements for the chemistry, manufacturing, and control of our programsNew
- 19Our product candidates for which we intend to seek approval as biologics may face competition sooner than anticipatedNew
- 20Current and future U.S. healthcare reform legislation or regulation may increase the difficulty and cost for us to obtain coverage for and commercialize any of our current or future product candidates and may adversely affect the prices we may setNew
- 21will continue to be responsible for assessing non-clinical (e.g., economic, social, ethical) aspects of health technology, and making decisions on pricing and reimbursementNew
- 22We are subject to various U.S. federal, state and foreign healthcare laws and regulations, which could increase compliance costs, and our failure to comply with these laws and regulations could harm our reputation, subject us to significant fines and liability or otherwise adversely affect our businessNew
- 23The successful commercialization of any of our current or future product candidates, if approved, will depend in part on the extent to which governmental authorities and health insurers establish coverage, adequate reimbursement levels and favorable pricing policiesNew
- 24Governments outside the United States tend to impose strict price controls, which may adversely affect our revenue, if any96% rewritten
Risks Related to Our Intellectual Property
- 25We do not currently solely own any issued patents or pending patent applications. Therefore, our ability to obtain and protect our patent rights, and protect other proprietary rights, is uncertain, exposing us to the possible loss of competitive advantageNew
- 26If we are unable to obtain or maintain necessary rights to our programs through acquisitions and in-licenses, our business may be materially harmedNew
- 27Our current collaboration with Kelun and any collaboration arrangements that we may enter into in the future may not be successful, which could adversely affect our ability to develop and commercialize our productsNew
- 28We may be subject to patent infringement claims or may need to file claims to protect our intellectual property, which could result in substantial costs and liability and prevent us from commercializing our potential productsNew
- 29We may be subject to claims that we have wrongfully hired an employee from a competitor or that our employees, consultants, or independent contractors have wrongfully used or disclosed confidential information of third partiesNew
- 30Changes to patent laws in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our productsNew
- 31assurance as to the degree and range of protections any of our patents, if issued, may afford us or whether patents will be issuedNew
- 32Obtaining and maintaining patent protection depends on compliance with various procedural, document submissions, fee payment, and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirementsNew
- 33We 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 productsNew
- 34We may become subject to claims challenging the inventorship or ownership of our patents and other intellectual propertyNew
- 35Patent terms may be inadequate to protect the competitive position of our product candidates for an adequate amount of timeNew
- 36The technology we currently license from Paragon and Kelun and any future technology we may license from various third parties in the future, may be subject to retained rightsNew
- 37We may be unable to protect the confidentiality of our trade secrets and other proprietary information100% rewritten
- 38BPCIA litigation is complex, costly, and unpredictable, and unfavorable outcomes could result in the invalidity or unenforceability of our patentsNew
Risks Related to Our Reliance on Third Parties
- 39We rely on third parties who operate in China, which may expose us to additional risksNew
Risks Related to Employee Matters, Managing Growth and Other Risks Related to Our Business
- 40In order to successfully implement our plans and strategies, we will need to grow the size of our organization and we may experience difficulties in managing this growthNew
- 41We are highly dependent on our key personnel and anticipate hiring new key personnel. If we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategyNew
- 42Our future growth may depend, in part, on our ability to operate in foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertaintiesNew
- 43Our estimates of market opportunity and forecasts of market growth may prove to be inaccurate, and even if the markets in which we compete achieve the forecasted growth, our business may not grow at similar rates, or at allNew
- 44Our employees, independent contractors, consultants, commercial collaborators, principal investigators, CROs, CMOs, suppliers, and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirementsNew
- 45If 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 have a material adverse effect on the success of our business74% rewritten
- 46We may be subject to adverse legislative or regulatory tax changes that could negatively impact our financial conditionNew
- 47We may acquire businesses or products, or form strategic alliances, in the future, and may not realize the benefits of such acquisitionsNew
- 48We maintain our cash at financial institutions, often in balances that exceed federally-insured limits. The failure of financial institutions could adversely affect our ability to pay our operational expenses or make other paymentsNew
Risks Related to Owning Our Ordinary Shares
- 49Preferred directors elected by the holders of our Series A Preferred Shares have the ability to control or significantly influence all matters submitted to our board of directors for approvalNew
- 50We are governed by Cayman Islands law, and certain provisions of our Articles of Association have anti-takeover implicationsNew
- 51damages, to the remedies of injunction, specific performance, or other equitable relief for any threatened or actual breach of the selection of the courts of the Cayman Islands as exclusive forumNew
- 52Future sales of shares by existing shareholders could cause our share price to declineNew
- 53We do not anticipate that we will pay any cash dividends in the foreseeable futureNew
- 54Our executive officers, directors, and principal shareholders have the ability to control or significantly influence all matters submitted to our shareholders for approvalNew
- 55If equity research analysts do not publish research or reports, or publish unfavorable research or reports about us, our business or our market, our share price and trading volume could decline63% rewritten
- 56Our ability to use Net Operating Loss (“NOL”) carryforwards and other tax attributes may be limited, including as a result of the MergerNew
- 57We may become exposed to costly and damaging liability claims, either when testing a product candidate in the clinic or at the commercial stage, and our product liability insurance may not cover all damages from such claimsNew
- 58Litigation costs and the outcome of litigation could have a material adverse effect on our businessNew
- 59Our business could be negatively impacted by sustainability or environmental, social and corporate governance (“ESG”) matters or our reporting of such mattersNew
Other Crescent Biopharma 10-Ks
- FY2024 10-K risk factors56 risks
Crescent Biopharma faces critical risks regarding its pending merger with GlycoMimetics and a concurrent $200.0 million private placement.
Filed Feb 13, 2025
About this page
The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.