What the changes say
- Transitioning from clinical stage to commercial stage following the approval of KOMZIFTI for NPM1-mutated AML in November 2025.
- Facing new execution, regulatory compliance, co-promotion, and commercialization risks.
What changed since the prior 10-K
New
- NewRisks Related to the Commercialization of KOMZIFTI and Our Product Candidates
our ability to obtain and maintain patent, trade secret and other intellectual property protection and statutory exclusivities for KOMZIFTI and ziftomenib, and to protect and enforce our intellectual property rights
We face risks protecting intellectual property for KOMZIFTI and ziftomenib, which could delay commercialization and hurt profitability.
- NewRisks Related to the Commercialization of KOMZIFTI and Our Product Candidates
If the market opportunities for KOMZIFTI are smaller than we believe, our revenue may be adversely affected, and our business may suffer
The actual market size and addressable patient population for KOMZIFTI in relapsed or refractory AML may be smaller than our estimates.
- NewRisks Related to the Commercialization of KOMZIFTI and Our Product Candidates
To successfully commercialize KOMZIFTI, we need to execute on our sales, marketing and distribution plans. The execution of our sales, marketing and distribution plans is, and will continue to be, expensive and time-consuming and we cannot be certain that we will be able to execute on these plans successfully
We rely on expensive sales execution and our co-promotion partner Kyowa Kirin to successfully commercialize KOMZIFTI.
- NewRisks Related to the Commercialization of KOMZIFTI and Our Product Candidates
Post-approval results for KOMZIFTI in larger numbers of patients, broader populations or real world clinical practice may not be consistent with the results from our clinical trials
Post-approval real-world safety and efficacy results in broader patient populations could differ from clinical trials and harm sales.
- NewRisks Related to the Commercialization of KOMZIFTI and Our Product Candidates
We have limited experience as a commercial company and our sales, marketing and distribution of KOMZIFTI may be unsuccessful or less successful than anticipated
As a company with no prior commercial experience, our sales, marketing, and distribution of KOMZIFTI may fail.
- NewRisks Related to Regulatory Approval of Our Product and Product Candidates and Other Legal Compliance Matters
We may be unable to maintain FDA approval of KOMZIFTI for adult patients with relapsed or refractory NPM1-mutated AML, which would severely and adversely affect our business and business prospects
We may fail to maintain FDA approval for KOMZIFTI for adult patients with relapsed or refractory NPM1-mutated AML.
- NewRisks Related to Regulatory Approval of Our Product and Product Candidates and Other Legal Compliance Matters
impede, halt or increase the costs of our activities and plans for further clinical development of ziftomenib
Ongoing commercial sales and manufacturing of KOMZIFTI are subject to continuous government regulation and potential restrictions.
- NewRisks Related to Regulatory Approval of Our Product and Product Candidates and Other Legal Compliance Matters
we may be required to change or stop ongoing clinical trials of ziftomenib, which would negatively impact the development of ziftomenib for other potential indications
We may need to change or stop ongoing clinical trials of ziftomenib for other potential indications.
- NewRisks Related to Regulatory Approval of Our Product and Product Candidates and Other Legal Compliance Matters
Our product candidates must be approved by the FDA in the United States and similar regulatory authorities outside the United States prior to commercialization
We must obtain FDA and foreign regulatory approval before commercializing product candidates.
- NewRisks Related to Regulatory Approval of Our Product and Product Candidates and Other Legal Compliance Matters
If we experience delays in obtaining approval or if we fail to obtain approval of ziftomenib beyond use as monotherapy in adult patients with relapsed or refractory NPM1-mutated AML, ziftomenib’s commercial prospects may be harmed and our ability to generate revenues will be materially impaired
Our post-approval requirements for KOMZIFTI include pediatric trials, long-term safety studies, and companion diagnostic availability.
- NewRisks Related to Regulatory Approval of Our Product and Product Candidates and Other Legal Compliance Matters
Although the FDA has granted Orphan Drug Designation to ziftomenib for the treatment of AML, we may not be able to obtain orphan drug exclusivity, and even if obtained, such exclusivity may not effectively protect ziftomenib from competition, which could limit the potential profitability of ziftomenib
We may not obtain or maintain orphan drug exclusivity for ziftomenib, exposing us to potential market competition.
- NewRisks Related to the Discovery and Development of Our Product Candidates
obtain appropriate coverage and reimbursement levels for the cost of ziftomenib in other indications from governmental authorities, private health insurers and other third-party payors
We may fail to obtain reimbursement for ziftomenib in other indications or struggle with future product development.
- NewRisks Related to the Discovery and Development of Our Product Candidates
If the results of our trials are not satisfactory to the FDA or foreign regulatory authorities for support of a marketing application, we may be required to expend significant additional resources to conduct additional trials in support of potential approval of our product candidates
- NewRisks Related to the Discovery and Development of Our Product Candidates
Our FIT-001 trial represents the first time our darlifarnib compound has been tested in humans. To date, treatment-related serious adverse events have been reported in fewer than 10% of patients treated with darlifarnib, and have been limited to neutropenia, febrile neutropenia and thrombocytopenia
- NewRisks Related to Our Financial Position and Need for Additional Capital
changes in governmental regulations, healthcare policy, pricing and reimbursement systems and our ability to set and maintain prices in the United States and other territories
- NewRisks Related to Our Financial Position and Need for Additional Capital
In November 2023, we entered into the ATM Facility, under which we may offer and sell, from time to time, at our sole discretion, shares of our common stock having an aggregate offering price of up to $150.0 million. We have not sold any shares of our common stock under the ATM Facility
- NewRisks Related to Employee Matters, Managing Growth and Macroeconomic Conditions
International trade policies, including tariffs, sanctions and trade barriers, may adversely affect our business, financial condition, results of operations and prospects
- NewRisks Related to Ownership of our Common Stock
We are a “smaller reporting company” and any decision on our part to comply only with certain reduced reporting and disclosure requirements applicable to smaller reporting companies could make our common stock less attractive to investors
- NewRisks Related to Ownership of our Common Stock
any action asserting a claim as to which the Delaware General Corporation Law confers jurisdiction on the Court of Chancery; and
- NewRisks Related to Ownership of our Common Stock
Further, unless we agree to an alternative forum, the federal district courts of the United States of America will be the exclusive forum for any actions or proceedings arising under the Securities Act
Dropped
- DroppedRisks Related to the Discovery and Development of Our Product Candidates
Our discovery, preclinical and clinical development activities are primarily focused on the development of targeted therapeutics for patients with genetically defined cancers, which is a rapidly evolving area of science, and the approach we are taking to discover and develop drugs may never lead to marketable products
Targeted therapeutics for genetically defined cancers represent a rapidly evolving, unproven scientific approach.
- DroppedRisks Related to the Discovery and Development of Our Product Candidates
ambiguous or negative interim results of our clinical trials or results that are inconsistent with earlier results
- DroppedRisks Related to the Discovery and Development of Our Product Candidates
The safety and tolerability observed in the Phase 2 registration-directed KOMET-001 trial were consistent with previous reports
Ambiguous or negative interim clinical trial results that fail to predict final outcomes.
- DroppedRisks Related to the Discovery and Development of Our Product Candidates
Our FIT-001 trial represents the first time our KO-2806 compound has been tested in humans. While we can anticipate potential side effects based upon the safety profiles of tipifarnib and other FTIs, we cannot predict the type, frequency or severity of side effects that we will observe in patients treated with KO-2806
- DroppedRisks Related to the Discovery and Development of Our Product Candidates
Preclinical and clinical testing of tipifarnib that has been conducted to date may not have been performed in compliance with applicable regulatory standards, which could lead to increased costs or material delays for their further development
- DroppedRisks Related to Our Financial Position and Need for Additional Capital
our ability to build our finance infrastructure and, to the extent required, improve our accounting systems and controls
- DroppedRisks Related to Our Dependence on Third Parties
Our collaboration with Kyowa Kirin is important to our business. If Kyowa Kirin ceases development efforts under our collaboration agreement, or if our collaboration agreement is terminated, we may not receive future milestone payments or royalties under the agreement and our business could be adversely affected
- DroppedRisks Related to Regulatory Approval of Our Product Candidates and Other Legal Compliance Matters
If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals in some or all planned regions, we will not be able to commercialize, or may be delayed in commercializing, our product candidates, and our ability to generate revenue will be materially impaired
Safety and tolerability observed in the Phase 2 KOMET-001 trial.
- DroppedRisks Related to Regulatory Approval of Our Product Candidates and Other Legal Compliance Matters
A Breakthrough Therapy Designation by the FDA may not lead to a faster development or regulatory review or approval process, and does not increase the likelihood that our product candidates will receive marketing approval
Unpredictable side effect profiles for the KO-2806 compound in human clinical testing.
- DroppedRisks Related to Regulatory Approval of Our Product Candidates and Other Legal Compliance Matters
The FDA and other regulatory agencies may require more extensive or expensive trials for combination product candidates than may be required for single agent pharmaceuticals
- DroppedRisks Related to Regulatory Approval of Our Product Candidates and Other Legal Compliance Matters
We may not be able to benefit from available regulatory exclusivity periods for tipifarnib if another company obtains regulatory approval for tipifarnib before we do
- DroppedRisks Related to Regulatory Approval of Our Product Candidates and Other Legal Compliance Matters
We may not be able to obtain orphan drug exclusivity for the product candidates for which we seek it, which could limit the potential profitability of such product candidates
- DroppedRisks Related to the Commercialization of Our Product Candidates
any restrictions on the use of our products together with other medications
Preclinical and clinical testing compliance of tipifarnib conducted by Janssen prior to license.
- DroppedRisks Related to the Commercialization of Our Product Candidates
We face substantial competition, which may result in others discovering, developing or commercializing competing products before or more successfully than we do
- DroppedRisks Related to the Commercialization of Our Product Candidates
The insurance coverage and reimbursement status of newly-approved products are uncertain. Failure to obtain or maintain coverage and adequate reimbursement for new or current products could limit our ability to market those products and decrease our ability to generate revenue
- DroppedRisks Related to Employee Matters, Managing Growth and Macroeconomic Conditions
Third-party expectations relating to environmental, social and governance factors may impose additional costs and expose us to new risks
- DroppedRisks Related to Ownership of our Common Stock
any action asserting a claim against us governed by the internal affairs doctrine
Building finance infrastructure and improving accounting systems as a clinical-stage company.
Reworded
- 100% rewrittenRisks Related to Regulatory Approval of Our Product and Product Candidates and Other Legal Compliance Matters
injunctions or the imposition of civil or criminal penalties
Updated to focus broadly on government investigations and potential FDA regulatory changes rather than specific EU pharmacovigilance and personal data rules.
- 76% rewrittenRisks Related to Our Financial Position and Need for Additional Capital
incur increased costs as a result of continued operations as a public company
Updated from pre-commercial language to reflect the actual November 2025 commercialization of KOMZIFTI and unproven revenue potential.
- 73% rewrittenRisks Related to Our Intellectual Property
We are pursuing additional U.S. and foreign patents for darlifarnib; however, there is no guarantee that any such patents will be granted or that, if granted, would provide protection against third parties
Switched patent term extension references from ziftomenib API to darlifarnib API.
Was: We are pursuing additional U.S. and foreign patents for ziftomenib; however, there is no guarantee that any such patents will be granted or that, if granted, would provide protection against third parties
- 73% rewrittenRisks Related to Our Financial Position and Need for Additional Capital
We may need to obtain substantial additional capital in connection with our continuing operations. If we are required to raise additional capital, doing so may cause dilution to our stockholders, restrict our operations or require us to relinquish certain rights to our technologies or product candidates
Capital raising and dilution risks maintained standard phrasing regarding future financing needs and debt covenants.
- 73% rewrittenRisks Related to Regulatory Approval of Our Product and Product Candidates and Other Legal Compliance Matters
Failure to obtain marketing approval in international jurisdictions would prevent our product candidates from being marketed abroad
Added Japan explicitly alongside the European Union for international marketing approval and reimbursement requirements.
- 71% rewrittenRisks Related to Employee Matters, Managing Growth and Macroeconomic Conditions
We have expanded our development, regulatory, operations, medical affairs, and commercial capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations
Expanded growth management risks to specifically include manufacturing, supply chain, and commercialization scaling challenges.
Was: We have expanded, or expect to expand, our development, regulatory, operations, medical affairs, market access, marketing and sales capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations
- 71% rewrittenRisks Related to Our Financial Position and Need for Additional Capital
Our limited operating history may make it difficult for you to evaluate the success of our business to date and to assess our future viability
Updated operating history to reflect transition from research and development to promoting, selling, and distributing KOMZIFTI.
- 69% rewrittenRisks Related to Ownership of our Common Stock
Changes in tax laws or regulations that are applied adversely to us or our customers may have a material adverse effect on our business, cash flow, financial condition or results of operations
Added the OBBBA enacted in 2025 to the list of U.S. tax laws impacting business operations.
- 67% rewrittenRisks Related to Our Intellectual Property
If we are unable to maintain the confidentiality of our trade secrets or other confidential information, our business and competitive position would be harmed
- 66% rewrittenRisks Related to Our Intellectual Property
We intend to rely upon a combination of regulatory exclusivity periods, patents, trade secret protection, trademarks, confidentiality agreements, and license agreements to protect the intellectual property related to our current product, product candidates and development programs
Was: We intend to rely upon a combination of regulatory exclusivity periods, patents, trade secret protection, trademarks, confidentiality agreements, and license agreements to protect the intellectual property related to our current product candidates and development programs
- 65% rewrittenRisks 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
- 63% rewrittenRisks Related to Regulatory Approval of Our Product and Product Candidates and Other Legal Compliance Matters
Recently enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval of our product candidates and commercialize our products, and may affect the prices we may obtain
Was: Recently enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates and affect the prices we may obtain
- 62% rewrittenRisks Related to the Discovery and Development of Our Product Candidates
Our product candidates may cause serious adverse events or have unacceptable side effects that could delay, limit or prevent their development
- 62% rewrittenRisks Related to the Commercialization of KOMZIFTI and Our Product Candidates
KOMZIFTI may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success
Was: Even if any of our product candidates receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success
- 61% rewrittenRisks Related to the Commercialization of KOMZIFTI and Our Product Candidates
Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of KOMZIFTI or any other approved products
Was: Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop
- 59% rewrittenRisks Related to the Commercialization of KOMZIFTI and Our Product Candidates
the inability to commercialize KOMZIFTI or any other approved products
Was: the inability to commercialize any products that we may develop
- 54% rewrittenRisks Related to Our Financial Position and Need for Additional Capital
We have limited historical product revenue, and we expect that our financial and operating results will vary significantly from period to period
Was: We are a clinical-stage company with no approved products and no historical product revenue. Consequently, we expect that our financial and operating results will vary significantly from period to period
- 53% rewrittenRisks Related to Ownership of our Common Stock
Our charter documents provide that the Court of Chancery of the State of Delaware will be the exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees
- 53% rewrittenRisks Related to Our Financial Position and Need for Additional Capital
We have incurred losses since our inception, expect to incur losses over the next several years and may never achieve or maintain profitability
Was: We expect to incur losses over the next several years and may never achieve or maintain profitability
- 44% rewrittenRisks Related to Our Dependence on Third Parties
Our product candidates, KOMZIFTI and any other approved products may compete with other product candidates and products for access to manufacturing facilities. There are a limited number of manufacturers that operate under cGMP regulations and that might be capable of manufacturing for us
Was: Our product candidates and any products that we may develop may compete with other product candidates and products for access to manufacturing facilities. There are a limited number of manufacturers that operate under cGMP regulations and that might be capable of manufacturing for us
- 40% rewrittenRisks Related to Ownership of our Common Stock
Anti-takeover provisions under our charter documents and Delaware law could delay or prevent a change of control which could limit the market price of our common stock and may prevent or frustrate attempts by our stockholders to replace or remove our current management
- 37% rewrittenRisks Related to the Discovery and Development of Our Product Candidates
Failure by us or our third-party collaborators to develop, validate and obtain regulatory approval for a diagnostic testing platform could harm our drug development strategy and operational results
- 34% rewrittenRisks Related to Our Intellectual Property
If we breach any of the agreements under which we license from third parties the development and/or commercialization rights to our product candidates, we could lose license rights that are important to our business and our operations could be materially harmed
- 27% rewrittenRisks Related to Ownership of our Common Stock
The price of our common stock may be volatile and may be influenced by numerous factors, some of which are beyond our control
- 26% rewrittenRisks Related to Ownership of our Common Stock
If we fail to maintain proper and effective internal controls, our ability to produce accurate and timely financial statements could be impaired, which could harm our operating results, our ability to operate our business and investors’ views of us
- 24% rewrittenRisks Related to Ownership of our Common Stock
We expect that significant additional capital will be needed in the future to continue our planned operations. To raise capital, we may sell common stock, convertible securities or other equity securities in one or more transactions at prices and in a manner we determine from time to time
- 22% rewrittenRisks Related to Our Dependence on Third Parties
the possible termination or nonrenewal of the agreement by the third party at a time that is costly or inconvenient for us
- 21% rewrittenRisks Related to Our Intellectual Property
We depend on our licensors to prosecute and maintain patents and patent applications that are material to our business. Any failure by our licensors to effectively protect these intellectual property rights could adversely impact our business and operations
All 85 risk factors
Headings as the filing states them, in filing order.
Risks Related to the Commercialization of KOMZIFTI and Our Product Candidates
- 01our ability to obtain and maintain patent, trade secret and other intellectual property protection and statutory exclusivities for KOMZIFTI and ziftomenib, and to protect and enforce our intellectual property rightsNew
- 02KOMZIFTI may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success62% rewritten
- 03If the market opportunities for KOMZIFTI are smaller than we believe, our revenue may be adversely affected, and our business may sufferNew
- 04To successfully commercialize KOMZIFTI, we need to execute on our sales, marketing and distribution plans. The execution of our sales, marketing and distribution plans is, and will continue to be, expensive and time-consuming and we cannot be certain that we will be able to execute on these plans successfullyNew
- 05Post-approval results for KOMZIFTI in larger numbers of patients, broader populations or real world clinical practice may not be consistent with the results from our clinical trialsNew
- 06We have limited experience as a commercial company and our sales, marketing and distribution of KOMZIFTI may be unsuccessful or less successful than anticipatedNew
- 07Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of KOMZIFTI or any other approved products61% rewritten
- 08the inability to commercialize KOMZIFTI or any other approved products59% rewritten
Risks Related to Regulatory Approval of Our Product and Product Candidates and Other Legal Compliance Matters
- 09We may be unable to maintain FDA approval of KOMZIFTI for adult patients with relapsed or refractory NPM1-mutated AML, which would severely and adversely affect our business and business prospectsNew
- 10impede, halt or increase the costs of our activities and plans for further clinical development of ziftomenibNew
- 11we may be required to change or stop ongoing clinical trials of ziftomenib, which would negatively impact the development of ziftomenib for other potential indicationsNew
- 12Our product candidates must be approved by the FDA in the United States and similar regulatory authorities outside the United States prior to commercializationNew
- 13If we experience delays in obtaining approval or if we fail to obtain approval of ziftomenib beyond use as monotherapy in adult patients with relapsed or refractory NPM1-mutated AML, ziftomenib’s commercial prospects may be harmed and our ability to generate revenues will be materially impairedNew
- 14injunctions or the imposition of civil or criminal penalties100% rewritten
- 15Failure to obtain marketing approval in international jurisdictions would prevent our product candidates from being marketed abroad73% rewritten
- 16Although the FDA has granted Orphan Drug Designation to ziftomenib for the treatment of AML, we may not be able to obtain orphan drug exclusivity, and even if obtained, such exclusivity may not effectively protect ziftomenib from competition, which could limit the potential profitability of ziftomenibNew
- 17analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, which may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers
- 18Recently enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval of our product candidates and commercialize our products, and may affect the prices we may obtain63% rewritten
- 19Governments outside the United States tend to impose strict price controls, which may adversely affect our revenues, if any
- 20If 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
Risks Related to the Discovery and Development of Our Product Candidates
- 21obtain appropriate coverage and reimbursement levels for the cost of ziftomenib in other indications from governmental authorities, private health insurers and other third-party payorsNew
- 22If the results of our trials are not satisfactory to the FDA or foreign regulatory authorities for support of a marketing application, we may be required to expend significant additional resources to conduct additional trials in support of potential approval of our product candidatesNew
- 23there may be changes in governmental regulations or administrative actions
- 24have the product removed from the market after obtaining marketing approval
- 25We anticipate that our current product candidates and any future product candidates may be used in combination with third-party drugs or biologics, some of which may still be in development, and we have limited or no control over the supply, regulatory status, or regulatory approval of such drugs or biologics
- 26Our product candidates may cause serious adverse events or have unacceptable side effects that could delay, limit or prevent their development62% rewritten
- 27Our FIT-001 trial represents the first time our darlifarnib compound has been tested in humans. To date, treatment-related serious adverse events have been reported in fewer than 10% of patients treated with darlifarnib, and have been limited to neutropenia, febrile neutropenia and thrombocytopeniaNew
- 28Failure by us or our third-party collaborators to develop, validate and obtain regulatory approval for a diagnostic testing platform could harm our drug development strategy and operational results37% rewritten
- 29Additionally, we or our collaborators may encounter production difficulties that could constrain the supply of the companion diagnostics, affect the ease of use, affect the price or have difficulties gaining acceptance of the use of the companion diagnostics in the clinical community
- 30We may find it difficult to enroll patients in our clinical trials. Difficulty in enrolling patients could delay or prevent clinical trials of our product candidates
- 31We may expend our limited resources to pursue a specific product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success
Risks Related to Our Financial Position and Need for Additional Capital
- 32We have incurred losses since our inception, expect to incur losses over the next several years and may never achieve or maintain profitability53% rewritten
- 33incur increased costs as a result of continued operations as a public company76% rewritten
- 34We have limited historical product revenue, and we expect that our financial and operating results will vary significantly from period to period54% rewritten
- 35changes in governmental regulations, healthcare policy, pricing and reimbursement systems and our ability to set and maintain prices in the United States and other territoriesNew
- 36We may need to obtain substantial additional capital in connection with our continuing operations. If we are required to raise additional capital, doing so may cause dilution to our stockholders, restrict our operations or require us to relinquish certain rights to our technologies or product candidates73% rewritten
- 37In November 2023, we entered into the ATM Facility, under which we may offer and sell, from time to time, at our sole discretion, shares of our common stock having an aggregate offering price of up to $150.0 million. We have not sold any shares of our common stock under the ATM FacilityNew
- 38Our limited operating history may make it difficult for you to evaluate the success of our business to date and to assess our future viability71% rewritten
- 39Adverse developments affecting the financial services industry, such as actual events or concerns involving liquidity, defaults or non-performance by financial institutions could adversely affect our current financial condition and projected business operations
Risks Related to Our Dependence on Third Parties
- 40the possible termination or nonrenewal of the agreement by the third party at a time that is costly or inconvenient for us22% rewritten
- 41Our product candidates, KOMZIFTI and any other approved products may compete with other product candidates and products for access to manufacturing facilities. There are a limited number of manufacturers that operate under cGMP regulations and that might be capable of manufacturing for us44% rewritten
Risks Related to Our Intellectual Property
- 42We intend to rely upon a combination of regulatory exclusivity periods, patents, trade secret protection, trademarks, confidentiality agreements, and license agreements to protect the intellectual property related to our current product, product candidates and development programs66% rewritten
- 43We are pursuing additional U.S. and foreign patents for darlifarnib; however, there is no guarantee that any such patents will be granted or that, if granted, would provide protection against third parties73% rewritten
- 44We depend on our licensors to prosecute and maintain patents and patent applications that are material to our business. Any failure by our licensors to effectively protect these intellectual property rights could adversely impact our business and operations21% rewritten
- 45Patent terms may be inadequate to protect our competitive position on our product and product candidates for a commercially meaningful length of time
- 46We may not be successful in obtaining or maintaining necessary third-party intellectual property rights for our development pipeline through acquisitions and in-licenses
- 47If we are unable to maintain the confidentiality of our trade secrets or other confidential information, our business and competitive position would be harmed67% rewritten
- 48If we breach any of the agreements under which we license from third parties the development and/or commercialization rights to our product candidates, we could lose license rights that are important to our business and our operations could be materially harmed34% rewritten
- 49the priority of invention of patented technology
- 50The patent applications of pharmaceutical and biotechnology companies involve highly complex legal and factual questions, which, if determined adversely to us, could negatively impact our patent position
- 51Changes in U.S. patent law, or laws in other countries, could diminish the value of patents in general, thereby impairing our ability to protect our product and product candidates
- 52Obtaining 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
- 53We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time consuming and unsuccessful
- 54Third 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 business65% rewritten
- 55We may not be able to protect our intellectual property rights throughout the world
Risks Related to Employee Matters, Managing Growth and Macroeconomic Conditions
- 56We are highly dependent on our Chief Executive Officer. Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel
- 57We have expanded our development, regulatory, operations, medical affairs, and commercial capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations71% rewritten
- 58Unfavorable global economic conditions could adversely affect our business, financial condition or results of operations
- 59In the ordinary course of our business, we and the third parties with whom we work process sensitive data, including personal data (such as health-related data), and, as a result, we and the third parties with whom we work face a variety of evolving threats that could cause security incidents
- 60Our business and operations would suffer in the event of system failures
- 61Actual or threatened public health epidemics or outbreaks may adversely impact our industry, including our clinical trials, our supply chain, our liquidity and access to capital markets and our business development activities
- 62Our operations are vulnerable to interruption by natural disasters, power loss, terrorist activity and other events beyond our control, the occurrence of which could materially harm our business
- 63International trade policies, including tariffs, sanctions and trade barriers, may adversely affect our business, financial condition, results of operations and prospectsNew
Risks Related to Ownership of our Common Stock
- 64Our stock price may fluctuate significantly and you may have difficulty selling your shares based on current trading volumes of our stock
- 65The price of our common stock may be volatile and may be influenced by numerous factors, some of which are beyond our control27% rewritten
- 66other events or factors, many of which are beyond our control
- 67We have broad discretion in the use of our cash and may not use our cash effectively, which could adversely affect our results of operations
- 68FINRA sales practice requirements may limit a stockholder’s ability to buy and sell our stock
- 69The resale of shares covered by our effective shelf registration statements could adversely affect the market price of our common stock in the public market, which result would in turn negatively affect our ability to raise additional equity capital
- 70We will incur increased costs and demands upon management as a result of complying with the laws and regulations affecting public companies, which could harm our operating results
- 71If we fail to maintain proper and effective internal controls, our ability to produce accurate and timely financial statements could be impaired, which could harm our operating results, our ability to operate our business and investors’ views of us26% rewritten
- 72We are a “smaller reporting company” and any decision on our part to comply only with certain reduced reporting and disclosure requirements applicable to smaller reporting companies could make our common stock less attractive to investorsNew
- 73We expect that significant additional capital will be needed in the future to continue our planned operations. To raise capital, we may sell common stock, convertible securities or other equity securities in one or more transactions at prices and in a manner we determine from time to time24% rewritten
- 74In addition, we may grant or provide for the grant of rights to purchase shares of our common stock pursuant to our 2015 Employee Stock Purchase Plan, or ESPP. As of December 31, 2025, we had 327,697 shares of common stock reserved for future issuance under the ESPP
- 75Anti-takeover provisions under our charter documents and Delaware law could delay or prevent a change of control which could limit the market price of our common stock and may prevent or frustrate attempts by our stockholders to replace or remove our current management40% rewritten
- 76Our charter documents provide that the Court of Chancery of the State of Delaware will be the exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees53% rewritten
- 77any action asserting a claim as to which the Delaware General Corporation Law confers jurisdiction on the Court of Chancery; andNew
- 78Further, unless we agree to an alternative forum, the federal district courts of the United States of America will be the exclusive forum for any actions or proceedings arising under the Securities ActNew
- 79Changes in tax laws or regulations that are applied adversely to us or our customers may have a material adverse effect on our business, cash flow, financial condition or results of operations69% rewritten
- 80Our ability to use net operating loss carryforwards and certain other tax attributes to offset future taxable income or taxes may be limited
- 81We do not intend to pay cash dividends on our capital stock in the foreseeable future
- 82If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about us, our business or our market, our stock price and trading volume could decline
- 83Our business could be negatively affected as a result of actions of activist stockholders, and such activism could impact the trading value of our securities
- 84Securities class action litigation could divert our management’s attention and harm our business and could subject us to significant liabilities
- 85Our employees, independent contractors, principal investigators, consultants, vendors, distributors and CROs may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements
Other Kura Oncology 10-Ks
- FY2024 10-K risk factors82 risks
Kura Oncology faces heavy clinical, regulatory, and financial risks as a pre-revenue biopharmaceutical company with no approved products.
Filed Feb 28, 2025
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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.