Kyntra Bio (KYNB) risk factors, FY2024 10-K

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 positron emission tomography (“PET”) imaging agent FG-3180)
2. 02Drug development and obtaining marketing authorization is a very difficult endeavor 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. 07Any 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
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 discovery, development and commercialization of product candidates
15. 15The success of any or all of these potential competitive products may negatively impact the development and potential for success of our products
16. 16Our product candidates may not achieve adequate market acceptance among physicians, patients, healthcare payors, and others in the medical community necessary for commercial success
17. 17any unfavorable publicity relating to the product candidate
18. 18No 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
19. 19neither experimental nor investigational

Risks Related to Our Reliance on Third Parties

1. 20If 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
2. 21In addition, if our collaboration partners are unsuccessful in their commercialization efforts (particularly in Europe and China), our results will be negatively affected
3. 22If 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
4. 23We 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
5. 24inability for FibroGen to meet timing and volume obligations to Astellas or other partners due to insufficient resources
6. 25We may have shortfalls, delays, or excesses in manufacturing
7. 26Certain 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. 27If 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. 28Our 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
3. 29Our 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. 30The 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. 31The 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. 32Intellectual property rights do not address all potential threats to any competitive advantage we may have
7. 33Patent 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. 34The 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

Risks Related to Government Regulation

1. 35The regulatory approval process is highly uncertain and we may not obtain regulatory approval for our product candidates
2. 36Our 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. 37Our 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
4. 38Additionally, 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. 39Preparing 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. 40We are subject to laws and regulations governing corruption, which require us to maintain costly compliance programs
7. 41If we fail to maintain an effective system of internal control, it may result in material misstatements in our financial statements
8. 42The impact of U.S. healthcare reform may adversely affect our business model
9. 43Roxadustat 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. 44Our employees may engage in misconduct or improper activities, which could result in significant liability or harm our reputation
11. 45disclose unauthorized activities to us
12. 46If we fail to comply with environmental, health or safety laws and regulations, we could incur fines, penalties or other costs

Risks Related to Our International Operations

1. 47If 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
2. 48We have established operations in China and there are a number of risks associated with international operations could materially and adversely affect our business
3. 49The pharmaceutical industry in China is highly regulated and such regulations are subject to change
4. 50Changes in U.S. and China relations, as well as relations with other countries, and/or regulations may adversely impact our business
5. 51We 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
6. 52There is a risk of manufacturing disruption due to geopolitical tensions in China and related to U.S. legislation impacting WuXi AppTec and WuXi Biologics
7. 53We may experience difficulties in successfully growing and sustaining sales of roxadustat in China
8. 54The retail prices of any product candidates that we develop will be subject to pricing control in China and elsewhere
9. 55FibroGen (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
10. 56Any 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
11. 57We 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
12. 58Because 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
13. 59We may be subject to tax inefficiencies associated with our offshore corporate structure
14. 60Our foreign operations, particularly those in China, are subject to significant risks involving the protection of intellectual property
15. 61Uncertainties with respect to the China legal system and regulations could have a material adverse effect on us
16. 62Changes in China’s economic, governmental, or social conditions could have a material adverse effect on our business
17. 63We may be subject to additional Chinese requirements, approvals or permissions in the future
18. 64We 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
19. 65If 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
20. 66Our 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

Risks Related to the Operation of Our Business

1. 67We may be required to recognize an impairment of our long-lived assets, which could adversely affect our financial performance
2. 68In 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
3. 69For additional details about these financing transactions, see Note 9, Senior Secured Term Loan Facilities and Note 10, Liability Related to Sale of Future Revenues, to the condensed consolidated financial statements
4. 70placing us at a possible competitive disadvantage with competitors that are less leveraged than us or have better access to capital
5. 71Most of our recent revenue has been earned through our roxadustat collaborations
6. 72We may encounter difficulties in managing our growth and expanding our operations, successfully
7. 73Loss of senior management and key personnel could adversely affect our business
8. 74We 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
9. 75If product liability lawsuits are brought against us, we may incur substantial liabilities and may have to limit commercial operations
10. 76reputational damage negatively impacting our other product candidates in development
11. 77Our business and operations would suffer in the event of computer system failures
12. 78Our third party service providers may be exposed to natural disasters and other catastrophes

Risks Related to Our Common Stock

1. 79The 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. 80the other factors described in this “Risk Factors” section
3. 81There is a risk that our common stock would be delisted due to not meeting the Nasdaq price requirement
4. 82On 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
5. 83We are a smaller reporting company, and the reduced disclosure requirements applicable to us may make our common stock less attractive to investors
6. 84We may engage in acquisitions that could dilute stockholders and harm our business
7. 85incur amortization expenses related to intangible assets or incur large and immediate write-offs
8. 86Provisions 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
9. 87These 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
10. 88Changes in our tax provision or exposure to additional tax liabilities could adversely affect our earnings and financial condition
11. 89Tariffs or other trade policy changes could harm our business
12. 90Our 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
13. 91We do not plan to pay dividends. Capital appreciation will be your sole possible source of gain, which may never occur
14. 92Our business or our share price could be negatively affected as a result of shareholder proposals or actions