KYNB 10-K & 10-Q changes, risk factors and insider trading

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

The future value drivers for FibroGen,Kyntra Bio, Inc. (“FibroGenKyntra Bio” or the “Company”) depend in large part on the continued commercial success of roxadustat in Europe, Japan,Europe and the People’s Republic of China (“China”),Japan, the potential of roxadustat for anemia associated with lower-risk myelodysplastic syndrome,syndromes (“MDS”), and the development of FG-3246 (in conjunction with our positron emission tomography (“PET”) imaging agent FG-3180), which is in clinical development for metastatic castration-resistant prostate cancer.cancer (“mCRPC”).

Drug development and obtaining marketing authorization is aare very difficult endeavorendeavors, 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.

The development, manufacturing, marketing, and selling of our products and product candidates are and will continue to be subject to extensive and rigorous review and regulation by numerous government authorities in the United States of America (“U.S.”) and in other countries where we intend to develop and, if approved, market any product candidates. Before obtaining regulatory approval for the commercial sale of any product candidate, we must demonstrate through extensive preclinical trials and clinical trials that the product candidate is safeeffective and effectivehas an acceptable safety profile for use in each indication for which approval is sought.

The drug development and approval processes are expensive and require substantial resources and time, and in general, very few product candidates that enter development ultimately receive regulatory approval. In addition, our collaboration partnerspartner for roxadustat havehas final control over development decisions in their respective territories and they may make decisions with respect to development or regulatory authorities that delay or limit the potential approval of roxadustat or increase the cost of development or commercialization. Accordingly, we may be unable to successfully develop or commercialize any of our other product candidates in one or more indications and jurisdictions.

our failure to adequately demonstrate to the satisfaction of regulatory authorities or an independent advisory committee that our product candidate is safeeffective and effectivehas an acceptable safety profile in a particular indication, or that such product candidate’s clinical and other benefits outweigh its safety risks;

our failure of clinical trials to meet the level of statistical significance required for approval;

failure by collaboration partners or other third parties such as clinical investigators to perform or complete their clinical programs in a timely manner, or at all; or Failurefailure of data from investigator-sponsored clinical trials, which are used as supportive evidence for our initial IND studies,trials to meet GCP standards.

When we have an investigator-sponsored trial, we would have to rely on sponsor’s data generated independently under sponsor’s institutional practices. As a result, there is an additional risk that results may differ in future trials run by FibroGenKyntra Bio as the sponsor.

FibroGenKyntra Bio may also elect to transition its manufacturing responsibilities to another party. There may be risks underlying this manufacturing transition, as well as new risks that may emerge after the new organization takes over manufacturing, if that were to happen.

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

The development and commercialization of new pharmaceutical products is highly competitive. Our future success depends on our ability and/or the ability of our collaboration partners to achieve and maintain a competitive advantage with respect to the development and commercialization of our product candidates. Our objective is to discover, develop and commercialize new products with superior efficacy, convenience, tolerability, and safety.

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. We face competition from generics that could enter the market after expiry of our composition of matter patent. The China Health Authority has accepted abbreviated new drug applications (“NDAs”) for over 20 generic roxadustat applicants and approved eight for marketing in China.

In addition, we will likely face competition from other companies developing products in the same diseases or indications in which we are developing or commercializing products.products, particularly for the prostate cancer market. We will also face competition for patient recruitment and enrollment for clinical trials.

Moreover, many of our competitors have significantly greater resources than we do. Large pharmaceutical companies have extensive experience, greater scale, and efficiency, in clinical testing, obtaining regulatory approvals, recruiting patients, manufacturing pharmaceutical products, and commercialization. If our collaboration partners and weKyntra Bio are not able to compete effectively against existing and potential competitors, our business and financial condition may be materially and adversely affected.

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 wouldcould suffer.

We have entered into an Evaluation Agreement with Fortis Therapeutics, Inc. (“Fortis”) under which we rely, in part, on Fortis and its development partners, including University of California, San Francisco, for the continued development of FG-3246 (in conjunction with our PET biomarker). While we control development of FG-3246 up tofor the 4-year evaluation period, we will be doing so under our investigational new drug application that references Fortis’s investigational new drug application. If Fortis were unwilling to cooperate with development efforts, our ability to develop FG-3246 (in conjunction with our PET biomarker) wouldcould be delayed.

Our current agreements with Astellas and AstraZeneca provide them with the right to terminate their agreements withfor us upon the occurrence of negative clinical results, delays in the development and commercialization of our product candidatesconvenience or adverse regulatory requirements or guidance. In addition, each of those agreements provides our partners the right to terminate any of those agreements upon written notice for convenience. The termination of any of our collaboration agreements would require us to fund and perform any further development and commercialization of roxadustat in the affected territory or pursue another collaboration, which we may be unable to do,breach, either of which could have an adverse effect on our business and operations. Moreover, if Astellas or AstraZeneca,Astellas, or any successor entity, were to determine that their collaborations with us are no longer a strategic priority, or if either of them or a successor were to reduce their level of commitment to their collaborations with us, our ability to profit from the commercialization of roxadustat could suffer.

For instance, the collaboration agreement between the Company and AstraZeneca, effective as of July 2013, for the development and commercialization of roxadustat for the treatment of anemia in the U.S. and all other countries in the world, other than China, not previously licensed to Astellas (the “AstraZeneca U.S./RoW Agreement”) was terminated on February 23,25, 2024 as amended and restated on August 29, 2025 (except for South Korea). Although our ongoingOur collaboration agreement with AstraZeneca for the development and commercialization of roxadustat for the treatment of anemia in China (the “AstraZeneca China Agreement”) continuesculminated throughas closinga result of the completion of the sale of FibroGen International and its subsidiaries pursuant to the share purchase agreement entered into by the Company and AstraZeneca Treasury Limited on February 20, 2025, as amended on August 29, 2025 (the “Share Purchase Agreement,Agreement”). thisThis eliminates any additional potential milestones or other payments AstraZeneca wouldcould have made under the AstraZeneca U.S./RoW Agreement except for potentially in South Korea. The likelihood receiving such payments was remote due to our withdrawal ofor the U.S.AstraZeneca newChina drug application for chronic kidney disease (“CKD”) anemia.Agreement. And while we are now investigating new licensing opportunities for roxadustat, there can be no assurance that we will find such a partner or be able to agree to a license on reasonable terms.

In addition, if our collaboration partners are unsuccessful in their commercialization efforts (particularly in Europe and China), our results will be negatively affected.

We do not have our own operating manufacturing facilities at this time other than our roxadustat manufacturing facility in China.time. We currently rely, and expect to continue to rely, on third parties to scale-up, manufacture and supply roxadustat and our other product candidates for drug product in Europe and other countries, and on our partner Astellas for drug product in Japan. We rely on third parties for distribution, including our collaboration partners and their vendors, except in China where we have established a jointly owned entity with AstraZeneca to manage most of the distribution in China.vendors. Risks arising from our reliance on third-party manufacturers include:

disruptions to the operations of our third-party manufacturers, distributors or suppliers unrelated to our product, including the merger, acquisition, or bankruptcy of a manufacturer or supplier or a catastrophic event, affecting our manufacturers, distributors or suppliers; and inability for FibroGenKyntra Bio to meet timing and volume obligations to Astellas or other partners due to insufficient resources.

If any third-party manufacturers terminate their engagements with us or fail to perform as agreed, we may be required to identify, qualify, and contract with replacement manufacturers (including entering into technical transfer agreements to share know-how), which process may result in significant costs and delays to our development and commercialization programs. Furthermore, premature termination of third-party manufacturers may result in additional cost burden for FibroGen.Kyntra Bio.

Our product candidates and any products that we may develop may compete with other product candidates and products for access and prioritization to manufacture. Certain third-party manufacturers may be contractually prohibited from manufacturing our product due to non-compete agreements with our competitors or a commitment to grant another party priority relative to our products. There are a limited number of third-party manufacturers that operate under cGMP and that might be capable of manufacturing to meet our requirements. Due to the limited number of third-party manufacturers with the contractual freedom, expertise, required regulatory approvals and facilities to manufacture our products on a commercial scale, identifying and qualifying a replacement third-party manufacturer would be expensive and time-consuming and may cause delay or interruptions in the production of our product candidates or products, which in turn may delay, prevent or impair our development and commercialization efforts. We also carry the risk that we may need to pay termination fees to other manufacturers in the event that we have to manufacture lower volumes or not at all depending on the results of our clinical trials. We may be subject to payments to other third-party manufacturers to cover portions or all of the committed manufacturing campaigns even if we do not need the material for clinical or commercial usage. In addition, third-party manufacturers tend to change their upfront fees or postponement/cancelation fees over time or upon initiation of additional contracts, and this may lead to unanticipated financial loss for FibroGen.Kyntra Bio.

In addition to the protection afforded by patents, we seek to rely on trade secret protection and confidentiality agreements to protect proprietary know-how, information, or technology that is not covered by our patents. Although our agreements require employees to acknowledge ownership by us of inventions conceived as a result of employment from the point of conception and, to the extent necessary, perfect such ownership by assignment, and we require employees, consultants, advisors and third parties who have access to our trade secrets, proprietary know-how and other confidential information and technology to enter into appropriate confidentiality agreements, we cannot be certain that our trade secrets, proprietary know-how and other confidential information and technology will not be subject to unauthorized disclosure, use, or misappropriation or that our competitors will not otherwise gain access to or independently develop substantially equivalent trade secrets, proprietary know-how and other information and technology. Furthermore, the laws of some foreign countries, in particular China, where we have operations, pending the sale of FibroGen International (Hong Kong) Ltd. to AstraZeneca Treasury Limited,countries do not protect proprietary rights to the same extent or in the same manner as the laws of the U.S. As a result, we may encounter significant problems in protecting and defending our intellectual property globally. If we cannot prevent unauthorized disclosure of our intellectual property related to our product candidates and technology to third parties, we may not establish or maintain a competitive advantage in our market, which could materially and adversely affect our business and operations.

In addition, ourcertain collaboration partners are larger, more complex organizations than ours, and the risk of inadvertent disclosure of our proprietary information may be increased despite their internal procedures and contractual obligations that we have in place with them. Despite our efforts to protect our trade secrets and other confidential information, a competitor’s discovery of such trade secrets and information could impair our competitive position and have an adverse impact on our business.

Many companies have encountered significant problems in protecting and defending intellectual property rights in certain countries. The legal systems of certain countries do not always favor the enforcement of patents, trade secrets, and other intellectual property rights, particularly those relating to pharmaceutical and biotechnology products, which could make it difficult for us to stop infringement of our patents, misappropriation of our trade secrets, or marketing of competing products in violation of our proprietary rights. For example, in China, we have had substantial difficulty effectively maintaining, prosecuting and enforcing our intellectual property rights. As we have experienced in multiple jurisdictions, proceedings to enforce our intellectual property rights in foreign countries could result in substantial costs and divert our efforts and attention from other aspects of our business, and could put our patents in these territories at risk of being invalidated or interpreted narrowly, or our patent applications at risk of not being granted, and could provoke third parties to assert claims against us. We may not prevail in all legal or other proceedings that we may initiate and, if we were to prevail, the damages or other remedies awarded, if any, may not be commercially meaningful. Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license.

Counterfeit products, including counterfeit pharmaceutical products, arecan be a significant problem, particularly in China.problem. Counterfeit pharmaceuticals are products sold or used for research under the same or similar names, or similar mechanism of action or product class, but which are sold without proper licenses or approvals, and are often lower cost, lower quality, different potency, or have different ingredients or formulations, and have the potential to damage the reputation for quality and effectiveness of the genuine product. Such products may be used for indications or purposes that are not recommended or approved or for which there is no data or inadequate data with regard to safety or efficacy. Such products divert sales from genuine products. If counterfeit pharmaceuticals illegally sold or used for research result in adverse events or side effects to consumers, we may be associated with any negative publicity resulting from such incidents. Consumers may buy counterfeit pharmaceuticals that are in direct competition with our pharmaceuticals, which could have an adverse impact on our revenues, business and results of operations. In addition, counterfeit products could be used in non-clinical or clinical studies, or could otherwise produce undesirable side effects or adverse events that may be attributed to our products as well, which could cause us or regulatory authorities to interrupt, delay or halt clinical trials and could result in the delay or denial of regulatory approval by the FDA or other regulatory authorities and potential product liability claims. With respect to China, although the government has recently been increasingly active in policing counterfeit pharmaceuticals, there is not yet an effective counterfeit pharmaceutical regulation control and enforcement system in China. As a result, we may not be able to prevent third parties from selling or purporting to sell our products in China. The existence of and any increase in the sales and production of counterfeit pharmaceuticals, or the technological capabilities of counterfeiters, could negatively impact our revenues, brand reputation, business and results of operations.

Outside the U.S., laws, regulations, and industry standards govern data privacy and security. For example, the European Union’s General Data Protection Regulation (“EU GDPR”), and the United Kingdom’s GDPR, Brazil’s General Data Protection Law (Lei Geral de Proteção de Dados Pessoais) (Law No. 13,709/2018), and China’s Personal Information Protection Law (“PIPL”)GDPR impose strict requirements for processing personal data, including health-related information. For example,Specifically, under the EU GDPR, companies may face fines of up to 20 million Euros or 4% of annual global revenue, whichever is greater; or private litigation related to processing of personal data brought by classes of data subjects or consumer protection organizations authorized at law to represent their interests. We also target customers in Asia and have operations in China and are subject to new and emerging data privacy regimes in Asia, including China’s PIPL, Japan’s Act on the Protection of Personal Information, and Singapore’s Personal Data Protection Act.

We are planning to bringutilizing artificial intelligence (“AI”) intowithin our IT platforms and services. However, our competitors might integrate AI faster or more effectively than us, which could put us at a disadvantage. Additionally, if AI helps create content, analyses, or recommendations that turn out to be flawed or biased, or even just perceived that way, it could hurt our business and financial health. AI can also lead to cybersecurity issues, potentially exposing personal data of users. Such incidents could damage our reputation and affect our performance. As AI technology rapidly evolves, and with the possibility of new regulations, we may need additional resources to ensure we use AI responsibly and ethically to avoid unforeseen negative consequences. Governments have passed and are likely to pass additional laws regulating generative AI. Our use of this technology could result in additional compliance costs, regulatory investigations and actions, and lawsuits.

If we or the third parties on which we rely fail, or are perceived to have failed, to address or comply with applicable data privacy and security obligations, we could face significant consequences, including but not limited to: government enforcement actions (e.g., investigations, fines, penalties, audits, inspections, and similar); litigation (including class-action claims); additional reporting requirements and/or oversight; bans on processing personal data; restrictions on use of AI tools which may involve personal data; and orders to destroy or not use personal data. Any of these events could have a material adverse effect on our reputation, business, or financial condition, including but not limited to: loss of customers; interruptions or stoppages in our business operations including clinical trials; inability to process personal data or to operate in certain jurisdictions; limited ability to develop or commercialize our products; expenditure of time and resources to defend any claim or inquiry; adverse publicity; or substantial changes to our business model or operations.

We must comply with a wide range of laws and regulations to prevent corruption, bribery, and other unethical business practices, including the U.S. Foreign Corrupt Practices Act (“FCPA”), anti-bribery and anti-corruption laws in other countries, particularly China.countries. The implementation and maintenance of compliance programs iscan be costly and such programs may be difficult to enforce, particularly where reliance on third parties is required.

Compliance with these anti-bribery laws is expensive and difficult, particularly in countries in which corruption is a recognized problem. In addition, the anti-bribery laws present particular challenges in the pharmaceutical industry because in many countries including China, hospitals are state-owned or operated by the government, and doctors and other hospital employees are considered foreign government officials. Furthermore, in certain countries (China in particular), hospitals and clinics are permitted to sell pharmaceuticals to their patients and are primary or significant distributors of pharmaceuticals. Certain payments to hospitals in connection with clinical studies, procurement of pharmaceuticals and other work have been deemed to be improper payments to government officials that have led to vigorous anti-bribery law enforcement actions and heavy fines in multiple jurisdictions, particularly in the U.S. and China.

In the pharmaceutical industry, corrupt practices include, among others, acceptance of kickbacks, bribes or other illegal gains or benefits by the hospitals and medical practitioners from pharmaceutical manufacturers, distributors or their third-party agents in connection with the prescription of certain pharmaceuticals. If our employees, partners, affiliates, subcontractors, distributors or third-party marketing firms violate these laws or otherwise engage in illegal practices with respect to their sales or marketing of our products or other activities involving our products, we could be required to pay damages or heavy fines by multiple jurisdictions where we operate, which could materially and adversely affect our financial condition and results of operations. The Chinese government has also sponsored anti-corruption campaigns from time to time, which could have a chilling effect on any future marketing efforts by us to new hospital customers. There have been recent occurrences in which certain hospitals have denied access to sales representatives from pharmaceutical companies because the hospitals wanted to avoid the perception of corruption. If this attitude becomes widespread among our potential customers, our ability to promote our products to hospitals may be adversely affected.

If we experience material weaknesses or otherwise fail to maintain an effective system of internal control over financial reporting, the accuracy and timing of our financial reporting and subsequently our liquidity and our access to capital markets may be adversely affected, we may be unable to maintain or regain compliance with applicable securities laws and the Nasdaq Stock Market LLC listing requirements, we may be subject to regulatory investigations and penalties, investors may lose confidence in our financial reporting, and our stock price may decline. In addition, if our internal control over financial reporting is deemed ineffective, efforts required to remediate an ineffective system of control over financial reporting may place a significant burden on management and add increased pressure on our financial resources and processes.

Healthcare reform in the U.S. in the future may include changes to Prescription Drug User Fee Act (PDUFA) funding, or other actions that impact FDA programs or personnel funded by user fees. If user fees are cut or eliminated, or if personnel funded by user fees are terminated at FDA, the result could increase uncertainty on review timelines or extend FDA review timelines (e.g., NDAs,new drug applications, Biologics License Applications), which can result in delays for regulatory action and adversely impact drug development timelines.

Further, in the U.S. there has been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which has resulted in several presidential executive orders, Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to drug pricing, reduce the cost of prescription drugs under government payor programs, and review the relationship between pricing and manufacturer patient programs. For example, in July 2021, the Biden administration released an executive order that included multiple provisions aimed at prescription drugs. In response to Biden’s executive order, on September 9, 2021, the U.S. Department of Health and Human Services (“HHS”) released a Comprehensive Plan for Addressing High Drug Prices that outlines principles for drug pricing reform. The plan sets out a variety of potential legislative policies that Congress could pursue as well as potential administrative actions HHS can take to advance these principles. In addition, on August 16, 2022, President Biden signed the Inflation Reduction Act of 2022 (“IRA”) into law, which among other things, extends enhanced subsidies for individuals purchasing health insurance coverage in Affordable Care Act marketplaces through plan year 2025. The IRA also eliminates the “donut hole” under the Medicare Part D program beginning in 2025 by significantly lowering the beneficiary maximum out-of-pocket cost and creating a new manufacturer discount program. Further, the IRA (1) directs HHS to negotiate the price of certain single-source drugs or biologics covered under Medicare, and (2) imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation. These provisions take effect progressively starting in fiscal year 2023, although the Medicare drug price negotiation program is currently subject to legal challenges. HHS has and will continue to issue and update guidance as these programs are implemented. It is currently unclear how the IRA will be implemented but is likely to have a significant impact on the pharmaceutical industry. Further, on February 14, 2023, HHS released a report outlining three new models for testing by the Centers for Medicare & Medicaid (“CMS”) Innovation Center which will be evaluated on their ability to lower the cost of drugs, promote accessibility, and improve quality of care. It is unclear whether the models will be utilized in any health reform measures in the future. Further, on December 7, 2023, the Biden administration announced an initiative to control the price of prescription drugs through the use of march-in rights under the Bayh-Dole Act. On December 8, 2023, the National Institute of Standards and Technology published for comment a Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights which for the first time includes the price of a product as one factor an agency can use when deciding to exercise march-in rights. While march-in rights have not previously been exercised, it is uncertain if that will continue under the new framework. At the state level, individual states are increasingly aggressive in passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.

Risks Related to Our International OperationsRisks

The U.S. government, including the SEC, has made statements and taken certain actions that have led to changes to U.S. and international relations, and will impact companies with connections to the U.S. or China, including imposing several rounds of tariffs affecting certain products manufactured in China, imposing certain sanctions and restrictions in relation to China, and issuing statements indicating enhanced review of companies with significant China-based operations.China. It is unknown whether and to what extent new legislation, executive orders, tariffs, laws or regulations will be adopted, or the effect that any such actions would have on companies with significant connections to China. We have business operations in the U.S.U.S., or to China, our industry or on us. Weand conduct contract manufacturing and development activities and have business operationsin both in the U.S. and China. Any unfavorable government policies on cross-border relations and/or international trade, including increased scrutiny on companies with significant China-based operations, capital controls or tariffs, may affect the competitive position of our drug products, the hiring of scientists and other research and development personnel, the demand for our drug products, the import or export of products and product components,components from China. While we have thus far imported products manufactured in China under exemptions from tariffs, if we are unable to do so in the future, the Company could encounter additional costs to supply our ability to raise capital, the market price of our common stock, or prevent us from commercializingproduct and sellingproduct our drug products in certain countries.candidates.

FibroGen,Kyntra Bio, Inc. (“FibroGenKyntra Bio” or the “Companywe”) is a biopharmaceutical company focused on development of novel therapies at the frontiers of cancer biology and anemia.

We are developing FG-3246, a potential first-in-class antibody-drug conjugate (“ADC”) targeting CD46, for the treatment of metastatic castration-resistant prostate cancer (“mCRPC”) and potentially other cancers. This program also includes the development of FG-3180, an associated CD46-targeted positron emission tomography (“PET”) biomarker and imaging agent. We initiated a Phase 2 monotherapy dose optimization study of FG-3246 for the treatment of mCRPC, along with the exploratory sub-study of FG-3180, in the third quarter of 2025.

We and our collaboration partners have developed roxadustat (爱瑞卓®, EVRENZOTM), which is currently approved in Europe, Japan, the People’s Republic of China (“China”), Europe, Japan, and numerous other countries for the treatment of anemia in chronic kidney disease (“CKD”) patients on dialysis and not on dialysis.

InOn FebruaryAugust 29, 2025, we enteredclosed into a share purchase agreement (the “Sharesale Purchase Agreement”) with AstraZeneca Treasury Limited pursuant to which we andof our subsidiary FibroGen China Anemiaoperations Holdings, Ltd. agreed to sell all of the issued and outstanding equity interests ofthrough FibroGen International (Hong Kong) Ltd. (“FibroGen International”) to AstraZeneca Treasury Limited.Limited pursuant to the share purchase agreement entered into with AstraZeneca Treasury Limited on February 20, 2025, as amended (the “Share Purchase Agreement”) for a total consideration of $220.4 million comprised of $85.0 million in enterprise value and $135.4 million in net cash held in China. AstraZeneca AB (“AstraZeneca”) iswas our long-time commercialization partner for roxadustat in greater China and South Korea.China. This sale includesincluded all of our roxadustat assets in China, including FibroGen International’s subsidiary FibroGen (China) Medical Technology Development Co., LtdLtd. (“FibroGen Beijing”) and its 51.1% interest in Beijing Falikang Pharmaceutical Co. Ltd. (“Falikang”). The transaction is expected to close by mid-2025, and is subject to customary closing conditions and closing deliverables, including receipt of regulatory approval from the China State Administration for Market Regulation.

WeKyntra willBio retainhas retained the rights to roxadustat in the United States of America (“U.S.”), Canada, Mexico, and in all markets not held by AstraZeneca or licensed to Astellas Pharma Inc. (“Astellas”). Astellas is commercializing roxadustat (EVRENZOTM) in Europe and Japan to treat anemia under two development and commercialization license agreements: one for Japan, and one for Europe, the Commonwealth of Independent States, the Middle East and South Africa.

Our revenue for the year ended December 31, 20242025 primarily included the$5.8 revenuesmillion recognizedof relateddrug product revenue from commercial-grade active pharmaceutical ingredient (“API”) or bulk drug product sales to the following:Astellas.

$16.1$2.0 million of drug product revenue related to API deliveries to Astellas; and $1.8 million of development revenue recognized under our collaboration agreements with our partners Astellas and AstraZeneca;AstraZeneca.

$12.4$16.9 million lower outsideclinical servicestrial expenses dueprimarily toassociated with the termination of pamrevlumab programs,programs windduring downthe second half of remaining2024 obligationsresponding andto costthe controltopline effortsclinical data results we reported in July 2024;

$11.6$15.0 million higher cost of goods sold mainly correspondinglycorresponding to the above-mentioned drug product revenue resulting from the AstraZeneca Termination and Transition Agreement in 2024 related to the AstraZeneca U.S./RoW Agreement,Agreement (as defined furtherbelow), belowwhich did not recur in 2025; and $6.8$8.0 million higherlower restructuringdrug chargedevelopment recordedexpenses associated with drug substance activities and logistic expenses related to thepamrevlumab reductionprograms inwhich forcewere plancompleted inand August 2024 with larger scale as compared to the reduction in force plan in July 2023.terminated.

Our research and development expenses were $95.7$23.5 million and $266.5$95.7 million for the years ended December 31, 20242025 and 2023,2024, respectively. Since inception and through December 31, 2024,2025, we have incurred a total of approximately $3.3 billion in research and development expenses, a majority of which relates to the development of roxadustat, pamrevlumab, FG-3246 and other HIF-PHhypoxia-inducible factor prolyl hydroxylase inhibitors. We expect to continue to incur significant expenses and operating losses over at least the next few years as we continue to make investments in research and development to advance our current product candidate portfolio. We consider the active management and development of our clinical pipeline to be particularly crucial to our long-term success. The process of conducting the necessary clinical research to obtain regulatory approval is costly and time consuming. We implemented cost reduction efforts in 2023 and 2024 in connection with our efforts to streamline operations to align with our business goals. As a result, operating expenses have decreased and may continue to decrease in certain areas over time.

During the year ended December 31, 2024,2025, we had a loss from continuing operations of $153.1$58.2 million or loss from continuing operations per basic and diluted share of $(1.53),$14.40, as compared to a loss from continuing operations of $323.0$153.1 million, or loss from continuing operations per basic and diluted share of $(3.32)$38.26 for the prior year, primarily due to a decrease in operating costs and expenses, offset by a decrease in revenues.

In 2018, we and Astellas entered into an amendment to the Astellas Japan Agreement that allows Astellas to manufacture roxadustat drug product for commercialization in Japan (the “Astellas Japan Amendment”). The related drug product revenue was ($2.9)$0.8 million and $15.7$(2.9) million for the years ended December 31, 20242025 and 2023,2024, respectively.

During the first quarter of 2021, we entered into an EU Supply Agreement with Astellas under the Astellas Europe Agreement to define general forecast, order, supply and payment terms for Astellas to purchase roxadustat bulk drug product from FibroGenus in support of commercial supplies (the “Astellas EU Supply Agreement”). The related drug product revenue was $4.9$5.1 million and $3.1$4.9 million for the years ended December 31, 20242025 and 2023,2024, respectively.

In July 2013, we entered into a collaboration agreement with AstraZeneca for roxadustat for the treatment of anemia in the U.S. and all territories except for China and those territories previously licensed to Astellas (the “AstraZeneca U.S./RoW Agreement”). In 2020, we entered into a Master Supply Agreement with AstraZeneca under the AstraZeneca U.S./RoW Agreement (the “AstraZeneca Master Supply Agreement”) to define general forecast, order, supply and payment terms for AstraZeneca to purchase roxadustat bulk drug product from FibroGenKyntra Bio in support of commercial supplies.

OnIn February 23, 2024, we entered into an agreement to terminate the AstraZeneca U.S./RoW Agreement with AstraZeneca, effective as ofamended Februaryand 25,restated 2024.on August 29, 2025. Pursuant to the AstraZeneca Termination and Transition Agreement, AstraZeneca returns all of their non-China roxadustat rights to us, with the exception of South Korea, and provides certain assistance during a transition period. In addition, as a part of this AstraZeneca Termination and Transition Agreement, AstraZeneca will receive tiered mid-single digit royalties on FibroGen’sKyntra Bio’s sales of roxadustat in the terminated territories, or thirty-five percent of all revenue FibroGenKyntra Bio receives if it licenses or sells such rights to a third-party. Neither party incurred any early termination penalties. The aggregate amount of consideration for milestone and upfront payments received under the AstraZeneca U.S./RoW Agreement through the termination totaled $439.0 million. In addition, resulting from the AstraZeneca Termination and Transition Agreement, FibroGenKyntra Bio and AstraZeneca settled the outstanding balances relating to past transactions under the AstraZeneca Master Supply Agreement. Accordingly, during the first quarter of 2024, we recorded a cumulative catch-up net adjustment of $25.7 million to the drug product revenue.

We accountaccounted for our investment in Falikang under the equity method, and Falikang iswas not consolidated into our consolidated financial statements. Our proportionate share of the reported profits or losses of Falikang, iswas included in the discontinued operations in the consolidated statement of operations, and the investment in unconsolidated subsidiary is included the held for sale assets in the consolidated balance sheet.sheet as of December 31, 2024. See Note 3, Discontinued Operations,Operations and Divestiture, to the consolidated financial statements for details.

Product revenue, net, which is included in the discontinued operations, consists primarily of revenues from sales of roxadustat commercial product to Falikang. Substantially all direct roxadustat product sales to distributors in China arewere made by Falikang, while FibroGen Beijing continues to sell roxadustat product directly in onelimited provinceareas in China. FibroGen Beijing manufactures and supplies commercial product to Falikang. The net transaction price for FibroGen Beijing’s product sales to Falikang isFalikang, based on a gross transaction price, adjusted for the estimated profit share.

We recognizerecognized revenue upon the transfer of control of commercial products to Falikang in an amount that reflectsreflected the allocation of transaction price of the China manufacturing and supply obligation (“China performancePerformance obligationObligation”) to the performance obligation satisfied during the reporting period. For our direct sales of commercial drug product, we recognizerecognized revenue when control of the promised good iswas transferred to the customer in an amount that reflectsreflected the consideration that we expectexpected to be entitled to in exchange for the product. As discussed in Note 3, Discontinued Operations and Divestiture, to the consolidated financial statements, the divestiture of FibroGen International was completed on August 29, 2025 and accordingly, the performance obligation to AstraZeneca was completely satisfied upon the closing of the divestiture. As a result, all the previously deferred revenues were recognized as revenue during the third quarter of 2025. During the years ended December 31, 20242025 and 2023,2024, included in the discontinued operations, we recognized $159.0$218.6 million and $89.1$159.0 million of net product revenue from the sales to Falikang, and $14.7$8.1 million and $11.9$14.7 million of net product revenue from sales directly to distributors in one province in China, respectively.

In April 2023, FibroGen and Eluminexwe entered into an Amended and Restated Exclusive License Agreement with Eluminex (“A&R Eluminex Agreement”) in order to add to the license rights to recombinant human collagen Type I (in addition to the rights to collagen Type III that were already licensed).

DevelopmentUnder our revenue recognition policy, development revenue includes co-development and other development related services. We recognize development services as revenue in the period in which they are billed to our partners, excluding China. As of December 31, 2024,2025, we do not expect to incur significant future co-development services. For China co-development services, we defer revenue until we begin to transfer control of the manufactured commercial product to AstraZeneca, which commenced in the first quarter of 2021 and we expect to continue through 2033, which reflects our best estimates. Other revenues consist of contract manufacturing revenue, patent transfer and sales of research and development material, which have not been material for any of the periods presented. Development and other revenues represented 7%9% and 39%7% of total revenues for the years ended December 31, 20242025 and 2023,2024, respectively.

The AstraZeneca U.S./RoW Agreement was terminated on February 23,25, 2024 (except for South Korea),. whileOn August 29, 2025, we closed the AstraZenecasale of our China Agreementoperations through FibroGen International to AstraZeneca Treasury Limited pursuant to the Share Purchase Agreement. For additional details, refer to Note 3, Discontinued Operations and relationshipDivestiture, continueto unaffected.the consolidated financial statements. In the future, we will continue generating revenue from collaboration agreements in the form of milestone payments and royalties on drug product sales. We expect that any revenues we generate will fluctuate from quarter to quarter due to the uncertain timing and amount of such payments and sales.

Development and other revenue recognizeddecreased under$1.4 ourmillion, collaborationor agreements with Astellas70% for the year ended December 31, 20242025 wascompared impactedto bythe year ended December 31, 2024, mainly due to the decrease in co-development billings dueresulting tofrom the closeout activities under our collaboration agreements with Astellas for roxadustat.

Drug product revenue increaseddecreased $8.9$21.8 million, or 48%79% for the year ended December 31, 20242025 compared to the year ended December 31, 2023.2024.

As of December 31, 2024,2025, the balances related to the API price true-up under the Astellas Japan Agreement were $2.5$1.6 million in accrued liabilities and $0.6 million in other long-term liabilities, representing the Company’sour best estimate of the timing for these amounts to be paid. As of December 31, 2023,2024, the related balances were $1.2$2.5 million in accrued liabilities and $0.7$0.6 million in other long-term liabilities.

As described above, pursuant to the AstraZeneca Termination and Transition Agreement related to the AstraZeneca U.S./RoW Agreement, FibroGenKyntra Bio and AstraZeneca settled the outstanding balances relating to past transactions under the AstraZeneca Master Supply Agreement. Accordingly, during the first quarter of 2024, we accounted for the termination of the AstraZeneca U.S./RoW agreementAgreement as a contract modification under the ASC 606 and recorded a cumulative catch-up net adjustment of $25.7 million to the drug product revenue, and received the cash during the second quarter of 2024. In addition, the related accrued liabilities of $11.2 million as of December 31, 2023 was settled during the second quarter of 2024.revenue.

If our manufacturers or we cannot properly manufacture the appropriate volume of product, we may experience delays in development, regulatory approval, launch, or successful commercialization.* We face substantial competition in the development and commercialization of product candidates.

Moreover, for any clinical trial to support a New Drug Application / Biologics License Application submission for approval, the U.S. Food and Drug Administration (“FDA”) and foreign regulatory authorities require compliance with regulations and standards (including goodGood clinicalClinical practicesPractice (“GCP”) requirements for designing, conducting, monitoring, recording, analyzing, and reporting the results of clinical trials) to ensure that (1) the data and results from trials are credible and accurate; and (2) that the rights, integrity and confidentiality of trial participants are protected. Although we rely on third parties to conduct our clinical trials, we as the sponsor remain responsible for ensuring that each of these clinical trials is conducted in accordance with its general investigational plan and protocol under legal and regulatory requirements, including GCP.

Even if we do obtain regulatory approval, our product candidates may be approved for narrower indications than we request, approval may be contingent on the performance of costly post-marketing clinical trials, or approval may require labeling that does not include the labeling claims necessary or desirable for the successful commercialization of that product candidate. In addition, if our product candidates produce undesirable side effects or safety issues, the FDA may require the establishment of Risk Evaluation and Mitigation Strategy (or other regulatory authorities may require the establishment of a similar strategy), that may restrict distribution of our approved products, if any, and impose burdensome implementation requirementsthat onimpact us.commercial performance.

If our manufacturers or we cannot properly manufacture the appropriate volume of product, we may experience delays in development, regulatory approval, launch or successful commercialization.*

There is a general risk of delayed drug supply due to delays experienced byfrom any third-party provider in the supply chain, including raw material and components suppliers, export and customs locations, and shipping companies. Any delay or interruption in the supply of our product candidates or products could have a material adverse effect on our business and operations.

We or our partners may add or change manufacturers, change our manufacturing processes, or change packaging specifications to accommodate changes in regulations, manufacturing equipment or to account for different processes at new or second source suppliers. Manufacturing changes made to one of our drugs or drug candidates, include, but are not limited to, demonstration of comparability to regulatory approved/ in approval products and processes, additional clinical trials, delays in development or commercialization, earlier expiration dates, shorter shelf life, or specification failures, and those changes may materially impact our operations and potential profitability. This includes the scenario that the change may be unsuccessful and cause delays or other negative impact.

natural disasters, such as pandemics, floods, storms, earthquakes, tsunamis, and droughts, or accidents such as fire, that affect facilities, possibly limit or postpone production, and increase costs; and failure to obtain a license to procure proprietary starting materials.

Even if we believe we have achieved positive clinical results, regulatory authorities conduct their own benefit-risk analysis and may reach different conclusions. Regulatory authorities may use, among other things, different statistical methods, different endpoints or definitions thereof, and different patient populations or sub-populations. Furthermore, while we may seek regulatory advice or agreement in key commercial markets prior to and after application for marketing authorization, regulatory authorities may change their approvability criteria based on the data, their internal analyses and external factors, including discussions with expert advisors. Regulatory authorities may approve one of our product candidates for narrower indications than we request or may grant approval contingent on the performance of costly post-approval clinical trials. In addition, even if we are able to provide positive data with respect to certain analyses, regulatory authorities may not include such claims on any approved labeling. The failure to obtain regulatory approval, or any label, population or other approval limitations in any jurisdiction, may significantly limit or delay our ability to generate revenues, and any failure to obtain such approval for all of the indications and labeling claims we deem desirable couldwould likely reduce our potential revenue.

No 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.*

Reference pricing is used by various Europe member states and parallel distribution, or arbitrage between low-priced and high-priced member states, can further reduce prices. In some countries, our partner or we may be required to conduct a clinical trial or other studies that compare the cost-effectiveness of our product candidates to other available products in order to obtain or maintain reimbursement or pricing approval. In the U.S., government efforts to implement Most Favored Nation pricing policies, which would tie the price of certain drugs to the lowest price paid for the same drug in other economically comparable countries, could result in similar downward pricing pressure domestically if such policies are adopted and applied to our products. The Inflation Reduction Act of 2022 established a Medicare drug price negotiation program administered by CMS, under which selected drugs are subject to government-negotiated “maximum fair prices.” Small-molecule drugs such as roxadustat become eligible for selection earlier in their lifecycle than biologics. If any of our products become subject to this program, or if this framework is expanded, our revenue and our collaboration partners’ commercialization economics could be adversely affected. Publication of discounts by third-party payors or authorities may lead to further pressure on the prices or reimbursement levels within the country of publication and other countries. If reimbursement of our products is unavailable or limited in scope or amount, or if pricing is set at unacceptable levels, our partner or we may elect not to commercialize our products in such countries, and our business and financial condition could be adversely affected.

For instance, the collaboration agreement between the Company and AstraZeneca, effective as of July 2013, for the development and commercialization of roxadustat for the treatment of anemia in the U.S. and all other countries in the world, other than the People’s Republic of China (“China”), not previously licensed to Astellas (the “AstraZeneca U.S./RoW Agreement”) was terminated on February 25, 2024 as amended and restated on August 29, 2025 (except for South Korea). Our collaboration agreement with AstraZeneca for the development and commercialization of roxadustat for the treatment of anemia in China (the “AstraZeneca China Agreement”) culminated as a result of the completion of the sale of FibroGen International (Hong Kong) Ltd. (“FibroGen International”) and its subsidiaries pursuant to the share purchase agreement entered into by the Company and AstraZeneca Treasury Limited on February 20, 2025, as amended on August 29, 2025 (the “Share Purchase Agreement”). This eliminates any additional potential milestones or other payments AstraZeneca could have made under the AstraZeneca U.S./RoW Agreement or the AstraZeneca China Agreement. And while we are now investigating new licensing opportunities for roxadustat, there can be no assurance that we will find such a partner or be able to agree to a license on reasonable terms.

termination of manufacturing agreements, fees associated with such termination, or nonrenewal of manufacturing agreements with third parties that may negatively impact our planned development and commercialization activities;

We are a biopharmaceutical company with two lead product candidates in clinical development, roxadustat for anemia in lower-risk MDS in the U.S. and elsewhere, and FG-3246 (in conjunction with our PET imaging agent FG-3180) for mCRPC. Most of our revenue generated to date has been based on our collaboration agreements. We continue to incur significant research and development and other expenses related to our ongoing operations. Our loss from continuing operations were $58.2 million and $153.1 million for the year ended December 31, 2025, and 2024, respectively. As of MarchJune 31,30, 2026, we had an accumulated deficit of $1.7 billion. As of MarchJune 31,30, 2026, we had capital resources from cash and cash equivalents of $37.0$50.6 million and short-term and long-term investments of $58.3$44.7 million. Despite the commercialization efforts of Astellas for roxadustat for the treatment of anemia caused by chronic kidney disease, we anticipate we will continue to incur losses on an annual basis for the foreseeable future. Furthermore, due to the sale of FibroGen International to AstraZeneca Treasury Limited, we will not be due any royalty, development or milestone payments under the AstraZeneca China Agreement. If we do not successfully develop and continue to obtain regulatory approval for our existing or any future product candidates and effectively manufacture, market and sell the product candidates that are approved, we may never achieve or sustain profitability on a quarterly or annual basis. Our prior losses, combined with expected future losses, have had and will continue to have an adverse effect on our stockholders’ equity (deficit) and working capital. Our failure to become and remain profitable would depress the market price of our common stock and could impair our ability to raise capital, expand our business, diversify our product offerings or continue our operations.

Legal proceedings, regardless of their merits or their ultimate outcomes, are costly, divert management’s attention and may materially adversely affect our business, results of operations, financial condition, prospects, and stock price. Such costs may include indemnification for proceedings against our current or former officers, and there is one ongoing proceeding against a former officer where costs couldare benow material butas areset uncertainforth atin thisthe time.Indemnification Agreements section under Note 10, Commitments and Contingencies. Although we maintain insurance for certain potential liabilities, such insurance does not cover all types and amounts of potential liabilities and is subject to various exclusions and caps on amounts recoverable. Even if we believe a claim is covered by insurance, insurers may dispute its entitlement to recovery for a variety of potential reasons, which may affect the timing and, if the insurers prevail, the amount of our recovery. There can be no assurance that our cash resources will be sufficient to satisfy these obligations, and we may be required to seek additional financing.

The 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.*

The market price of our common stock has at times experienced price volatility and may continue to be volatile. For example, during the 12-month period ended MarchJune 31,30, 2026, the closing price of our common stock on the Nasdaq Global Select Market has ranged from $5.16$5.25 per share to $12.38$12.43 per share. In general, pharmaceutical, biotechnology and other life sciences company stocks have been highly volatile in the current market. The volatility of pharmaceutical, biotechnology and other life sciences company stocks is sometimes unrelated to the operating performance of particular companies, and biotechnology and life science companies’ stocks often respond to trends and perceptions rather than financial performance. In particular, the market price of shares of our common stock could be subject to wide fluctuations in response to the following factors:

The notification received has no immediate effect on the listing of Kyntra Bio’s common stock on Nasdaq Global Select Market. UnderWe thetimely Nasdaq Rules, we have 45 days (May 18, 2026) to submitsubmitted a plan to Nasdaq to regain compliance and if such plan is accepted, Nasdaq may grant us with an extension of up to 180 days (September 29, 2026) to evidence compliance.

The U.S. Food and Drug Administration (“FDA”) granted roxadustat Orphan Drug Designation for the treatment of MDS in December 2025.

Operating costs and expenses for the three and six months ended MarchJune 31,30, 2026 remained relatively flatincreased compared to the same periodperiods a year ago primarily as a result of the net effect of the following, respectively:

$1.4$0.8 million and $2.2 million lower employee-related expenses primarily due to reduced headcount;

$1.4$0.9 million and $2.3 million lower equipment and facilities-related expenses due to cost control efforts;

$1.3$0.3 million and $1.6 million lower stock-based compensation primarily resulting from lower stock price and reduced headcount; and $3.9$3.8 million higher cost of goods sold recorded during the threesix months ended MarchJune 31,30, 2026 corresponding to the drug product revenue.

For the three months ended MarchJune 31,30, 2026, we had a lossincome from continuing operations of $15.1$12.0 million, or an earnings per basic and diluted share of $2.96, as compared to a loss of $13.7 million, or a loss per basic and diluted share of $3.74,$3.38, asfor comparedthe tosame period a year ago, and for the six months ended June 30, 2026, we had a loss from continuing operations of $16.8$3.2 million, or a loss per basic and diluted share of $4.15,$0.78, as compared to a loss of $30.4 million, or a loss per basic and diluted share of $7.54, for the same period a year ago, primarily due to the increasegain on deconsolidation of subsidiary, offset by increases in revenueoperating ascosts discussedand above.expenses and decreases in revenue.

Cash and cash equivalents, investments and accounts receivable totaled $100.3$95.7 million at MarchJune 31,30, 2026, a decrease of $9.1$13.7 million from December 31, 2025, primarily due to the cash used by operations as discussed under the Liquidity and Capital Resources section below.

An exploratory sub-study willis evaluateevaluating FG-3180, a companion PET imaging agent, as a diagnostic radiopharmaceutical. All patients deemed eligible for participation in the Phase 2 trial will participate in the sub-study evaluating FG-3180 prior to randomization.

The diagnosed prevalence of MDS in the U.S. is estimated to be betweenapproximately 60,000 and 170,000,74,000, and continues to rise as more therapies become available and patients are living longer with MDS. Annual incidence rates are estimated to be 4.9/100,00020,000 adults in the U.S.U.S., 70% of whom are considered lower-risk MDS.

We arehave advancing preparations for the Phase 3 trial, while evaluating internal development and potential partnership opportunities for this late-stage program. We are now finalizingfinalized the Phase 3 trial protocol for roxadustat for the treatment of anemia in patients with lower-risk MDS and high transfusion burden after receiving further comments from the FDA. Our goal is to initiate the Phase 3 trial in the fourth quarter of 2026.

The Phase 3 trial is planned to assess the safety and efficacy of roxadustat in a randomized, double-blind, placebo-controlled design in approximately 200 patients with lower-risk MDS. Alignment was reached with the FDA on key Phase 3 design elements, including the patient population (patients requiring ≥ 4 RBC units in two consecutive 8-week periods prior to randomization, who are refractory to, intolerant to, or ineligible for prior erythropoiesis-stimulating agentsagent (ESA) therapy), dose regimen.regimen, Forand placebo control group with a 2:1 randomization. We have selected 8-week transfusion independence (“TI”) (over the first 24 weeks) as the primary endpoint of RBCthe transfusionstudy. independence,The weFDA arerecommended consideringa independencelonger duration of TI as the primary endpoint (16-weeks over either48 weeks), however, an 8-week periodprimary orendpoint 16-weekis period.consistent with past and current placebo-controlled studies in this indication. We are including 12-week, 16-week, and 24-week TI (each over 48 weeks) as key secondary endpoints. Based on consultation with medical professionals, we believe the design of the study should provide sufficient evidence of patient benefit in this population of high-transfusion burden lower-risk MDS patients. The study is powered to detect meaningful statistically significant differences for the primary endpoint and all key secondary endpoints.

In athe post-hoc analysis of patients with high transfusion burden (4 or more packed RBC units over two consecutive 8-week periods), 36% of the 22 roxadustat patients achieved transfusion independence,independence (8 weeks within the first 28 weeks), versus 7% of the 15 placebo patients (nominal p-value of 0.04). Treatment-emergent adverse events (“TEAEs”) were generally lower grade and managed medically with no new safety signals.

Exclusive License and Option to Acquire Fortis Therapeutics

In June 2005, we entered into a collaboration agreement with Astellas for the development and commercialization (but not manufacture) of roxadustat for the treatment of anemia in Japan (“Astellas Japan Agreement”). In April 2006, we entered into the Europe Agreement with Astellas for roxadustat for the treatment of anemia in Europe, the Commonwealth of Independent States, the Middle East, and South Africa (“Astellas Europe Agreement”). Under these agreements, the aggregate amount of consideration received through MarchJune 31,30, 2026 totaled $790.1 million. Based on the current development plans for roxadustat in Japan and Europe, we do not expect to receive most or all of the additional potential milestones under the Astellas Japan Agreement or the Astellas Europe Agreement.

In 2018, we and Astellas entered into an amendment to the Astellas Japan Agreement that allows Astellas to manufacture roxadustat drug product for commercialization in Japan (the “Astellas Japan Amendment”). The related drug product revenue was $($2.22.9) million for the three months ended June 30, 2026, and immaterial for the three months ended June 30, 2025, and ($5.1) million and $1.8 million for the threesix months ended MarchJune 31,30, 2026 and 2025, respectively.

During the first quarter of 2021, we entered into an EU Supply Agreement with Astellas under the Astellas Europe Agreement to define general forecast, order, supply and payment terms for Astellas to purchase roxadustat bulk drug product from us in support of commercial supplies (the “Astellas EU Supply Agreement”). The related drug product revenue was $5.7$1.4 million and $0.8$1.2 million for the three months ended MarchJune 31,30, 2026 and 2025, and $7.0 million and $2.0 million for the six months ended June 30, 2026 and 2025, respectively.

Product revenue, net, was $39.8$19.7 million and $59.5 million for the three and six months ended MarchJune 31,30, 2025, respectively, majority of which were from the sales to Falikang, and was included in the discontinued operations. As discussed in Note 2,3, Discontinued Operations and Divestiture, to the condensed consolidated financial statements, the divestiture of FibroGen International was completed on August 29, 2025 and accordingly, the performance obligation to AstraZeneca was completely satisfied upon the closing of the divestiture.

Development revenue includes co-development and other development related services. We recognize development services as revenue in the period in which they are billed to our partners, excluding China. As of MarchJune 31,30, 2026, we do not expect to incur significant future co-development services. Other revenues consist of contract manufacturing revenue, patent transfer and sales of research and development material. Development and other revenue have not been material for any of the periods presented.

Total revenue increaseddecreased $1.0$2.8 million, or 36%,209%, for the three months ended MarchJune 31,30, 2026, and decreased $1.8 million, or 45%, for the six months ended June 30, 2026, respectively, compared to the same periodperiods a year ago for the reasons discussed in the sections below.

Drug product revenue, net increaseddecreased $0.9$2.8 million, or 35%,(230)%, for the three months ended MarchJune 31,30, 2026, and decreased $1.9 million, or 50%, for the six months ended June 30, 2026, respectively, compared to the same periodperiods a year ago.

As of MarchJune 31,30, 2026, the balances related to the API price true-up under the Astellas Japan Agreement were $3.8$2.9 million in accrued liabilities, representing our best estimate of the timing for these amounts to be paid.

We recognized royalty revenue as drug product revenue, from the deferred revenue under the Astellas Europe Agreement, of $1.5$1.4 million and $0.8$1.2 million for the three months ended MarchJune 31,30, 2026 and 2025, and $2.9 million and $2.0 million for the six months ended June 30, 2026 and 2025, respectively. It is our best estimate that the remainder of the deferred revenue will be recognized as revenue and when uncertainty is resolved, based on the performance of roxadustat product sales in the Astellas territory.

Total operating costs and expenses decreasedincreased $0.1$2.7 million, or 1%,20%, for the three months ended MarchJune 31,30, 2026, and increased $2.6 million, or 8%, for the six months ended June 30, 2026, respectively, compared to the same periodperiods a year ago for the reasons discussed in the sections below.

Cost of goods sold increased $3.9 million, or 1,529%, for the three months ended MarchJune 31,30, 2026 and 2025 were immaterial. Cost of goods sold increased $3.8 million, or 1,119%, for the six months ended June 30, 2026, compared to the same period a year ago, primarily due to the cost associated with the intermediates drug product revenue of $3.3 million and the costs of bulk drug product delivered to Astellas of $0.9 million during the threesix months ended MarchJune 31,30, 2026.

Research and development expenses consist of independent research and development costs and the gross amount of costs associated with work performed under collaboration agreements. Research and development expenses include employee-related expenses for research and development functions, expenses incurred under agreements with clinical research organizations, other clinical and preclinical costs and allocated direct and indirect overhead costs, such as facilities costs, information technology costs and other overhead. We expense research and development costs as incurred. We recognize costs for certain development activities based on an evaluation of the progress to completion of specific tasks using information and data provided to us by our vendors and our clinical sites. We have implemented a significant cost reduction plan in the U.S. in the third quarter of 2024. As a result, research and development expenses have overall decreased and may continue to decrease in certain areas over time.

The following table summarizes our research and development expenses incurred during the three and six months ended MarchJune 31,30, 2026 and 2025:

Research and development expenses decreasedincreased $1.6$1.0 million, or 18%,16%, for the three months ended MarchJune 31,30, 2026, compared to the same period a year ago, primarily as a result of the net effect of the following:

Increase of $2.2 million in clinical trials expenses associated with FG-3246 Phase 2 trials; and Decrease of $1.1$0.8 million employee-related costs primarily due to lower headcount;headcount.

DecreaseIncrease of $0.7$2.1 million in stock-basedclinical compensationtrials primarilyexpenses resultingassociated fromwith lowerFG-3246 stockPhase price2 and reduced headcounttrials; and Increase of $1.1$1.6 million in outside services due to higher activities associated with FG-3246 studies in the current year period, as compared to activities related to pamrevlumab programs, which were completed and terminated in the prior year period.

Selling, general and administrative (“SG&A”) expenses consist primarily of employee-related expenses for executive, operational, finance, legal, compliance, and human resource functions. SG&A expenses also include professional fees, accounting and legal services, other outside services, recruiting fees and expenses associated with obtaining and maintaining patents. We have implemented a significant cost reduction plan in the U.S. in the third quarter of 2024. As a result, SG&A expenses have overall decreased and may continue to decrease over time.

SG&A expenses decreasedincreased $2.2 million, or 28%,31%, for the three months ended MarchJune 31,30, 2026, compared to the same period a year ago, primarily as a result of the net effect of the following, respectively:

Decrease of $1.1$1.8 million in equipment and facilities-related expenses and decrease of $1.1 million in outside services due to cost control efforts; and Decrease of $0.6 million in stock-based compensation primarily resulting from lower stock price and reduced headcount.