Kyntra Bio (KYNB) risk factors, FY2025 10-K

Kyntra Bio's FY2025 10-K, filed Mar 16, 2026, lists 76 risk factors in 7 groups. Against the prior year's 92: 6 new, 22 dropped, 16 substantially reworded.

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Risk factors listed
767 groups
New this year
6vs 92 last year
Dropped
22since the prior 10-K
Substantially reworded
16of those kept
Section length
20k wordsItem 1A

What the changes say

  • Kyntra Bio highlights risks from single-source roxadustat API suppliers in China and reliance on partners like Astellas and Fortis.

What changed since the prior 10-K

New

  • NewRisks Related to the Development and Commercialization of Our Product Candidates

    ability to monitor patients and collect patient data adequately during and after treatment

    We face risks regarding our ability to adequately monitor patients and collect data during clinical trials for our product candidates.

  • NewRisks Related to the Development and Commercialization of Our Product Candidates

    We expect that in many cases, the products that we commercialize will compete with existing marketed products of companies that have large, established commercial organizations

    Our commercialized products will compete with established companies and other developers, particularly in the prostate cancer market and for trial recruitment.

  • NewRisks Related to Our Reliance on Third Parties

    We have active collaboration agreements with respect to the development and commercialization of roxadustat with Astellas Pharma Inc. (“Astellas”)

    Our collaboration agreement for roxadustat with Astellas could be terminated, and our AstraZeneca U.S./RoW Agreement was terminated on February 25, 2024.

  • NewInternational Risks

    Within the next year, we may face costs from the wind-up of the Cayman Subsidiary (as defined below), and may not receive some of the AZ Holdbacks (as defined below) related to the sale of FibroGen International and its subsidiaries

    We may face wind-up costs for our Cayman Subsidiary and may not receive the remaining $4.0 million AZ Holdback from the sale of FibroGen International.

  • NewInternational Risks

    We depend on third party suppliers in China, and there are risks inherent to utilizing third-party manufacturing facilities

    We rely on single-source suppliers in China for roxadustat API without a secondary source and face periodic unannounced inspections by Chinese regulators.

  • NewRisks Related to the Operation of Our Business

    As material inducement for NovaQuest to enter into the RIFA, we granted NovaQuest a security interest over our rights, title and interest in and to the revenue interest payments and intellectual property related to roxadustat and the Astellas territories

    We granted NovaQuest a security interest over our revenue interest payments and intellectual property for roxadustat and Astellas territories under the RIFA.

Dropped

  • DroppedRisks Related to the Development and Commercialization of Our Product Candidates

    Any delays in completing our clinical trials will increase the costs of the trial, delay the product candidate development and approval process and jeopardize our ability to commence marketing and generate revenues. Any of these occurrences may materially and adversely harm our business, operations, and prospects

  • DroppedRisks Related to Our International Operations

    If we are unable to consummate the sale of FibroGen International to AstraZeneca Treasury Limited, the trading price of our common stock and our business may be harmed

  • DroppedRisks Related to Our International Operations

    We have established operations in China and there are a number of risks associated with international operations could materially and adversely affect our business

  • DroppedRisks Related to Our International Operations

    The pharmaceutical industry in China is highly regulated and such regulations are subject to change

  • DroppedRisks Related to Our International Operations

    We use our own manufacturing facility in China to produce roxadustat drug product for the market in China. There are risks inherent to operating commercial manufacturing facilities, and we may not be able to continually meet market demand

  • DroppedRisks Related to Our International Operations

    We may experience difficulties in successfully growing and sustaining sales of roxadustat in China

  • DroppedRisks Related to Our International Operations

    The retail prices of any product candidates that we develop will be subject to pricing control in China and elsewhere

    Complexity of FG-3246 development using FG-3180 PET imaging agent as screening.

  • DroppedRisks Related to Our International Operations

    FibroGen (China) Medical Technology Development Co., Ltd. (“FibroGen Beijing”) would be subject to restrictions on paying dividends or making other payments to us, which may restrict our ability to satisfy our liquidity requirements

  • DroppedRisks Related to Our International Operations

    Any capital contributions from us to FibroGen Beijing must be approved by the Ministry of Commerce in China, and failure to obtain such approval may materially and adversely affect the liquidity position of FibroGen Beijing

  • DroppedRisks Related to Our International Operations

    Because FibroGen Beijing’s funds are held in banks that do not provide insurance, the failure of any bank in which FibroGen Beijing deposits its funds could adversely affect our business

  • DroppedRisks Related to Our International Operations

    Our foreign operations, particularly those in China, are subject to significant risks involving the protection of intellectual property

  • DroppedRisks Related to Our International Operations

    Uncertainties with respect to the China legal system and regulations could have a material adverse effect on us

  • DroppedRisks Related to Our International Operations

    Changes in China’s economic, governmental, or social conditions could have a material adverse effect on our business

  • DroppedRisks Related to Our International Operations

    We may be subject to additional Chinese requirements, approvals or permissions in the future

  • DroppedRisks Related to Our International Operations

    We may also be required to obtain certain approvals from Chinese authorities before transferring certain scientific data abroad or to foreign parties or entities established or actually controlled by them

  • DroppedRisks Related to Our International Operations

    If the Chinese government determines that our corporate structure does not comply with Chinese regulations, or if Chinese regulations change or are interpreted differently in the future, the value of our common stock may decline

  • DroppedRisks Related to Our International Operations

    Our operations in China subject us to various Chinese labor and social insurance laws, and our failure to comply with such laws may materially and adversely affect our business, financial condition and results of operations

  • DroppedRisks Related to the Operation of Our Business

    In April 2023, we entered into a financing agreement (“Financing Agreement”) with a $75 million senior secured term loan with investment funds managed by Morgan Stanley Tactical Value, as lenders, and Wilmington Trust, National Association, as the administrative agent

  • DroppedRisks Related to the Operation of Our Business

    Most of our recent revenue has been earned through our roxadustat collaborations

  • DroppedRisks Related to the Operation of Our Business

    Loss of senior management and key personnel could adversely affect our business

  • DroppedRisks Related to Our Common Stock

    There is a risk that our common stock would be delisted due to not meeting the Nasdaq price requirement

  • DroppedRisks Related to Our Common Stock

    On March 14, 2025, FibroGen appealed this determination and therefore such delisting has been stayed. Our common stock will remain listed on the Nasdaq pending the ruling by the Nasdaq Hearings Panel

Reworded

  • 86% rewrittenRisks Related to Our Reliance on Third Parties

    If our collaborations were terminated or if our partners were unwilling or unable to contribute or participate in the collaborations, our ability to successfully develop and commercialize the relevant product candidate could suffer

    Removed references to the terminated AstraZeneca agreement for roxadustat and updated collaboration risk language regarding Fortis Therapeutics.

    Was: If our collaborations were terminated or if our partners were unwilling or unable to contribute or participate in the collaborations, our ability to successfully develop and commercialize the relevant product candidate would suffer

  • 82% rewrittenInternational Risks

    Changes in U.S. and China relations, as well as relations with other countries, and/or regulations may adversely impact our business

    Removed references to SEC statements and U.S. government actions regarding China-based operations, focusing instead on cross-border tariffs and trade policies.

  • 69% rewrittenRisks Related to the Operation of Our Business

    We are exposed to the risks associated with litigation, investigations, regulatory proceedings, and other legal matters, any of which could have a material adverse effect on us

    Removed explicit mention of ongoing securities class action and derivative lawsuits, framing litigation risk more generally.

  • 69% rewrittenRisks Related to the Development and Commercialization of Our Product Candidates

    We face substantial competition in the development and commercialization of product candidates

    Removed specific mention of facing competition from generic drugs entering the market after patent expiration.

    Was: We face substantial competition in the discovery, development and commercialization of product candidates

  • 68% rewrittenInternational Risks

    We may be subject to currency exchange rate fluctuations and currency exchange restrictions with respect to our partner ’ s operations in Japan and Europe, which could adversely affect our financial performance

    Removed Renminbi currency risks and Chinese government controls on convertibility and remittance.

    Was: We may be subject to currency exchange rate fluctuations and currency exchange restrictions with respect to our operations in China as well as our partner’s operations in Japan and Europe, which could adversely affect our financial performance

  • 61% rewrittenRisks Related to the Development and Commercialization of Our Product Candidates

    We are substantially dependent on the success of our lead products roxadustat and FG-3246 (in conjunction with our PET (as defined below) imaging agent FG-3180)

    Updated company name from FibroGen, Inc. to Kyntra Bio, Inc., removed references to roxadustat commercial success in China, and updated clinical indications.

    Was: We are substantially dependent on the success of our lead products roxadustat and FG-3246 (in conjunction with our positron emission tomography (“PET”) imaging agent FG-3180)

  • 46% rewrittenRisks Related to Government Regulation

    The impact of U.S. healthcare reform may adversely affect our business model

    Retained healthcare reform and PDUFA funding risk language essentially unchanged with minor formatting adjustments.

  • 46% rewrittenRisks Related to Our Common Stock

    the other factors described in this “ Risk Factors ” section

    Removed the specific mention of being subject to securities class action litigation from the stock volatility risk factor.

  • 39% rewrittenRisks Related to Our Intellectual Property

    Our commercial success may depend on our avoiding infringement of the patents and other proprietary rights of third parties as well as on enforcing our patents and other proprietary rights against third parties

  • 35% rewrittenRisks Related to the Operation of Our Business

    We may be required to recognize an impairment of our long-lived assets, which could adversely affect our financial performance

  • 34% rewrittenInternational Risks

    We may be subject to tax inefficiencies associated with our offshore corporate structure

  • 33% rewrittenRisks Related to the Operation of Our Business

    placing us at a possible competitive disadvantage with competitors that are less leveraged than us or have better access to capital

  • 29% rewrittenRisks Related to Government Regulation

    We are subject to laws and regulations governing corruption, which require us to maintain costly compliance programs

  • 28% rewrittenRisks Related to Our Reliance on Third Parties

    We currently rely, and expect to continue to rely, on third parties to conduct many aspects of our product manufacturing and distribution, and these third parties may terminate these agreements or not perform satisfactorily

  • 24% rewrittenRisks Related to Our Intellectual Property

    The existence of counterfeit pharmaceutical products in pharmaceutical markets may compromise our brand and reputation and have a material adverse effect on our business, operations and prospects

  • 24% rewrittenRisks Related to Government Regulation

    Our data processing activities may subject us to numerous data privacy and security obligations, such as various laws, regulations, guidance, industry standards, external and internal privacy and security policies, contractual requirements, and other obligations relating to data privacy and security

All 76 risk factors

Headings as the filing states them, in filing order.

Risks Related to the Development and Commercialization of Our Product Candidates

  1. 01We are substantially dependent on the success of our lead products roxadustat and FG-3246 (in conjunction with our PET (as defined below) imaging agent FG-3180)61% rewritten
  2. 02Drug development and obtaining marketing authorization are very difficult endeavors, and we may ultimately be unable to obtain regulatory approval for our various product candidates in one or more jurisdictions and in one or more indications
  3. 03Even if we believe our clinical trials, as well as, investigator-sponsored trials are successful, regulatory authorities may not agree that our completed clinical trials provide adequate data on safety or efficacy. Approval by one regulatory authority does not ensure approval by any other regulatory authority
  4. 04Preclinical, Phase 1, and Phase 2 clinical trial results may not be indicative of the results that may be obtained in larger clinical trials
  5. 05We do not know whether our ongoing or planned clinical trials will need to be redesigned based on interim results or if we will be able to achieve sufficient patient enrollment or complete planned clinical trials on schedule
  6. 06changes in laws or regulations
  7. 07ability to monitor patients and collect patient data adequately during and after treatmentNew
  8. 08Our product candidates may cause or have attributed to them undesirable side effects or have other properties that delay or prevent their regulatory approval or limit their commercial potential
  9. 09Clinical trials of our product candidates may not uncover all possible adverse effects that patients may experience
  10. 10If our manufacturers or we cannot properly manufacture the appropriate volume of product, we may experience delays in development, regulatory approval, launch or successful commercialization
  11. 11We, or our collaboration partner, may not be able to accurately forecast clinical or commercial supply requirements and we may not meet or we may exceed our requirements as to quantities, scale-up, yield, cost, potency or quality in compliance with cGMP
  12. 12Please see also our risk factor titled “ We may have shortfalls, delays, or excesses in manufacturing. ”
  13. 13Regulatory authorities will do their own benefit risk analysis and may reach a different conclusion than we or our partners have, and these regulatory authorities may base their approval decision on different analyses, data, and statistical methods than ours
  14. 14We face substantial competition in the development and commercialization of product candidates69% rewritten
  15. 15We expect that in many cases, the products that we commercialize will compete with existing marketed products of companies that have large, established commercial organizationsNew
  16. 16The success of any or all of these potential competitive products may negatively impact the development and potential for success of our products
  17. 17Our product candidates may not achieve adequate market acceptance among physicians, patients, healthcare payors, and others in the medical community necessary for commercial success
  18. 18any unfavorable publicity relating to the product candidate
  19. 19No or limited reimbursement or insurance coverage of our approved products, by third-party payors may render our products less attractive to patients and healthcare providers
  20. 20neither experimental nor investigational

Risks Related to Our Reliance on Third Parties

  1. 21If our collaborations were terminated or if our partners were unwilling or unable to contribute or participate in the collaborations, our ability to successfully develop and commercialize the relevant product candidate could suffer86% rewritten
  2. 22We have active collaboration agreements with respect to the development and commercialization of roxadustat with Astellas Pharma Inc. (“Astellas”)New
  3. 23In addition, if our collaboration partners are unsuccessful in their commercialization efforts (particularly in Europe), our results will be negatively affected
  4. 24If our preclinical and clinical trial contractors do not properly perform their agreed upon obligations, we may not be able to obtain or may be delayed in receiving regulatory approvals for our product candidates
  5. 25We currently rely, and expect to continue to rely, on third parties to conduct many aspects of our product manufacturing and distribution, and these third parties may terminate these agreements or not perform satisfactorily28% rewritten
  6. 26inability for Kyntra Bio to meet timing and volume obligations to Astellas or other partners due to insufficient resources
  7. 27We may have shortfalls, delays, or excesses in manufacturing
  8. 28Certain components of our products are acquired from single-source suppliers or without long-term supply agreements. The loss of these suppliers, or their failure to supply, would materially and adversely affect our business

Risks Related to Our Intellectual Property

  1. 29If our efforts to protect our proprietary and exclusively licensed technologies are not adequate, we may not be able to compete effectively in our market
  2. 30Our commercial success may depend on our avoiding infringement of the patents and other proprietary rights of third parties as well as on enforcing our patents and other proprietary rights against third parties39% rewritten
  3. 31Our reliance on third parties and agreements with collaboration partners requires us to share our trade secrets, which increases the possibility that a competitor may discover them or that our trade secrets will be misappropriated or disclosed
  4. 32The cost of maintaining our patent protection is high and requires continuous review and diligence. We may not be able to effectively maintain our intellectual property position throughout the major markets of the world
  5. 33The laws of some foreign countries do not protect proprietary rights to the same extent as do the laws of the U.S., and we may encounter significant problems in securing and defending our intellectual property rights outside the U.S
  6. 34Intellectual property rights do not address all potential threats to any competitive advantage we may have
  7. 35Patent protection on our product candidates may expire before we are able to develop and commercialize the product, or before we are able to recover our investment in the product
  8. 36The existence of counterfeit pharmaceutical products in pharmaceutical markets may compromise our brand and reputation and have a material adverse effect on our business, operations and prospects24% rewritten

Risks Related to Government Regulation

  1. 37The regulatory approval process is highly uncertain and we may not obtain regulatory approval for our product candidates
  2. 38Our current and future relationships with customers, physicians, and third-party payors are subject to healthcare fraud and abuse laws, false claims laws, transparency laws, and other regulations. If we are unable to comply with such laws, we could face substantial penalties
  3. 39Our data processing activities may subject us to numerous data privacy and security obligations, such as various laws, regulations, guidance, industry standards, external and internal privacy and security policies, contractual requirements, and other obligations relating to data privacy and security24% rewritten
  4. 40Additionally, companies that transfer personal data out of the European Economic Area and the United Kingdom to other jurisdictions are subject to scrutiny from regulators, individual litigants, and activities groups
  5. 41Preparing for and complying with these obligations requires us to devote resources and may necessitate changes to our services, information technologies, systems, and practices and to those of any third parties that process personal data on our behalf
  6. 42We are subject to laws and regulations governing corruption, which require us to maintain costly compliance programs29% rewritten
  7. 43If we fail to maintain an effective system of internal control, it may result in material misstatements in our financial statements
  8. 44The impact of U.S. healthcare reform may adversely affect our business model46% rewritten
  9. 45Roxadustat is considered a Class 2 substance on the 2019 World Anti-Doping Agency Prohibited List that could limit sales and increase security and distribution costs for our partners and us
  10. 46Our employees may engage in misconduct or improper activities, which could result in significant liability or harm our reputation
  11. 47disclose unauthorized activities to us
  12. 48If we fail to comply with environmental, health or safety laws and regulations, we could incur fines, penalties or other costs

International Risks

  1. 49Within the next year, we may face costs from the wind-up of the Cayman Subsidiary (as defined below), and may not receive some of the AZ Holdbacks (as defined below) related to the sale of FibroGen International and its subsidiariesNew
  2. 50Changes in U.S. and China relations, as well as relations with other countries, and/or regulations may adversely impact our business82% rewritten
  3. 51We depend on third party suppliers in China, and there are risks inherent to utilizing third-party manufacturing facilitiesNew
  4. 52There is a risk of manufacturing disruption due to geopolitical tensions in China and related to U.S. legislation impacting WuXi AppTec, WuXi Biologics, and WuXi XDC
  5. 53We may be subject to currency exchange rate fluctuations and currency exchange restrictions with respect to our partner ’ s operations in Japan and Europe, which could adversely affect our financial performance68% rewritten
  6. 54We may be subject to tax inefficiencies associated with our offshore corporate structure34% rewritten

Risks Related to the Operation of Our Business

  1. 55We may be required to recognize an impairment of our long-lived assets, which could adversely affect our financial performance35% rewritten
  2. 56As material inducement for NovaQuest to enter into the RIFA, we granted NovaQuest a security interest over our rights, title and interest in and to the revenue interest payments and intellectual property related to roxadustat and the Astellas territoriesNew
  3. 57For additional details about this financing transaction, see Note 9, Liability Related to Sale of Future Revenues , to the consolidated financial statements
  4. 58placing us at a possible competitive disadvantage with competitors that are less leveraged than us or have better access to capital33% rewritten
  5. 59We may encounter difficulties in managing our growth and expanding our operations, successfully
  6. 60We are exposed to the risks associated with litigation, investigations, regulatory proceedings, and other legal matters, any of which could have a material adverse effect on us69% rewritten
  7. 61If product liability lawsuits are brought against us, we may incur substantial liabilities and may have to limit commercial operations
  8. 62reputational damage negatively impacting our other product candidates in development
  9. 63Our business and operations would suffer in the event of computer system failures
  10. 64Our third party service providers may be exposed to natural disasters and other catastrophes

Risks Related to Our Common Stock

  1. 65The market price of our common stock may be highly volatile, and you may not be able to resell your shares at or above your purchase price
  2. 66the other factors described in this “ Risk Factors ” section46% rewritten
  3. 67We are a smaller reporting company, and the reduced disclosure requirements applicable to us may make our common stock less attractive to investors
  4. 68We may engage in acquisitions that could dilute stockholders and harm our business
  5. 69incur amortization expenses related to intangible assets or incur large and immediate write-offs
  6. 70Provisions in our charter documents and Delaware law may have anti-takeover effects that could discourage an acquisition of us by others and may prevent attempts by our stockholders to replace or remove our current directors or management
  7. 71These provisions, alone or together, could delay or prevent hostile takeovers and changes in control or changes in our management by making it more difficult for stockholders to replace members of our Board of Directors, which is responsible for appointing the members of our management
  8. 72Changes in our tax provision or exposure to additional tax liabilities could adversely affect our earnings and financial condition
  9. 73Tariffs or other trade policy changes could harm our business
  10. 74Our certificate of incorporation designates courts located in Delaware as the sole forum for certain proceedings, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees
  11. 75We do not plan to pay dividends. Capital appreciation will be your sole possible source of gain, which may never occur
  12. 76Our business or our share price could be negatively affected as a result of shareholder proposals or actions

Other Kyntra Bio 10-Ks

  • FY2024 10-K risk factors
    92 risks

    Roxadustat and FG-3246 drive our business value and commercial success. Drug development faces extensive regulatory review and intense competition globally. Third-party manufacturers and collaborators are critical to our supply chain and clinical success.

    Filed Mar 17, 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.