KYNTRA BIO, INC. 10-Q

ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS. You should read the following discussion and analysis of our financial condition and results of operations in conjunction with the condensed consolidated financial statements and the notes thereto included elsewhere in this Quarterly Report on Form 10-Q, and in our Securities and Exchange Commission (“SEC”) filings, including our Annual Report on Form 10-K for the year ended December 31, 2025 filed with the SEC on March 16, 2026 (“2025 Form 10-K”). FORWARD-LOOKING STATEMENTS The following discussion and information contained elsewhere in this Quarterly Report on Form 10-Q contain “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended (“Exchange Act”), Section 27A of the Securities Act of 1933, as amended (“Securities Act”) and within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are often identified by the use of words such as “may,” “will,” “expect,” “anticipate,” “intend,” “could,” “should,” “estimate,” or “continue,” and similar expressions or variations. In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Quarterly Report on Form 10-Q, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. Such forward-looking and other statements are subject to risks, uncertainties and other factors that could cause actual results and the timing of certain events to differ materially from future results expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in the section titled “Risk Factors,” set forth in Part II, Item 1A of this Quarterly Report on Form 10-Q. The forward-looking statements in this Quarterly Report on Form 10-Q represent our views as of the date of this Quarterly Report on Form 10-Q. We anticipate that subsequent events and developments will cause our views to change. New risks emerge from time to time, and it is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking and other statements we may make. In light of these risks, uncertainties, and assumptions, the forward-looking events and circumstances discussed in this Quarterly Report on Form 10-Q may not occur, and actual results could differ materially and adversely from those anticipated or implied in the forward-looking and other statements. While we may elect to update these forward-looking and other statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should, therefore, not rely on these forward-looking and other statements as representing our views as of any date subsequent to the date of this Quarterly Report on Form 10-Q and are cautioned not to place undue reliance on such forward-looking statements. BUSINESS OVERVIEW Kyntra Bio, Inc. (“Kyntra Bio” or “we”) is a biopharmaceutical company focused on development of novel therapies in oncology and rare disease. In January 2026, we announced our rebranding from “FibroGen, Inc.” to “Kyntra Bio, Inc.,” representing the next step of our transformation and focus on oncology and rare disease assets. On January 8, 2026, our common stock began trading under the new Nasdaq symbol “KYNB.” 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 developed roxadustat (爱瑞卓®, EVRENZO TM ), which is currently approved in Europe, Japan, the People’s Republic of China (“China”), and numerous other countries for the treatment of anemia in chronic kidney disease (“CKD”) patients on dialysis and not on dialysis. 22 Table of Contents On August 29, 2025, we closed the sale of our China operations through FibroGen International (Hong Kong) Ltd. (“FibroGen International”) to AstraZeneca Treasury 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”) was our long-time commercialization partner for roxadustat in greater China. This sale included all of our roxadustat assets in China, including FibroGen International’s subsidiary FibroGen (China) Medical Technology Development Co., Ltd. (“FibroGen Beijing”) and its 51.1% interest in Beijing Falikang Pharmaceutical Co. Ltd. (“Falikang”). Kyntra Bio has 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 (EVRENZO TM ) 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. We continue to advance our development plan for roxadustat in anemia associated with lower-risk myelodysplastic syndromes (“MDS”), a high-value indication with significant unmet medical need. We have finalized the Phase 3 trial protocol for roxadustat for the treatment of anemia in patients with lower-risk MDS with high transfusion burden and are continuing with preparations for the Phase 3 trial, while evaluating internal development and potential partnership opportunities for this late-stage program. Kyntra Bio’s goal is to initiate the Phase 3 trial in the fourth quarter of 2026. The U.S. Food and Drug Administration (“FDA”) granted roxadustat Orphan Drug Designation for the treatment of MDS in December 2025. Financial Highlights Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 (in thousands, except for per share data) Result of Operations Revenue $ (1,474 ) $ 1,348 $ 2,264 $ 4,088 Operating costs and expenses 16,100 13,400 33,656 31,060 Total interest and other, net 29,547 (1,723 ) 28,233 (3,567 ) Income (loss) from continuing operations 11,974 (13,683 ) (3,158 ) (30,449 ) Income (loss) from continuing operations per share - basic and diluted $ 2.96 $ (3.38 ) $ (0.78 ) $ (7.54 ) June 30, 2026 December 31, 2025 (in thousands) Balance Sheet Cash and cash equivalents $ 50,644 $ 47,872 Short-term investments 40,674 41,106 Accounts receivable 347 216 Long-term investments $ 4,012 $ 20,160 Our revenue for the three and six months ended June 30, 2026 primarily included $(1.6) million and $1.9 million, respectively, of drug product revenue from commercial-grade active pharmaceutical ingredient (“API”) or bulk drug product sales to Astellas. As a comparison, our revenue for the three and six months ended June 30, 2025 primarily included $1.2 million and $3.8 million, respectively, of drug product revenue from commercial-grade API or bulk drug product sales to Astellas. The revenue decreased compared to the same periods a year ago primarily due to the change in estimate of variable consideration related to the API shipments fulfilled under the terms of Astellas Japan Amendment (as defined below). Operating costs and expenses for the three and six months ended June 30, 2026 increased compared to the same periods a year ago primarily as a result of the net effect of the following, respectively: • $3.5 million and $4.3 million higher legal expenses primarily related to estimated indemnification costs associated with a former officer; • $2.2 million and $2.1 million higher clinical trial expenses associated with FG-3246 Phase 2 trials; 23 Table of Contents • $0.8 million and $2.2 million lower employee-related expenses primarily due to reduced headcount; • $0.9 million and $2.3 million lower equipment and facilities-related expenses due to cost control efforts; • $0.3 million and $1.6 million lower stock-based compensation primarily resulting from lower stock price and reduced headcount; and • $3.8 million higher cost of goods sold recorded during the six months ended June 30, 2026 corresponding to drug product revenue. In April 2026, our subsidiary, FibroGen Europe, voluntarily filed for bankruptcy with the Finnish bankruptcy court. On April 16, 2026, the Helsinki District Court declared FibroGen Europe bankrupt and appointed an estate administrator to oversee the bankruptcy estate. As a result, we determined that we no longer maintained a controlling financial interest in FibroGen Europe and therefore deconsolidated the subsidiary effective April 16, 2026. Upon deconsolidation, we derecognized the subsidiary’s assets and liabilities and recognized a $30.9 million gain on deconsolidation. See Note 2, Deconsolidation of European Subsidiary , to the condensed consolidated financial statements for details. For the three months ended June 30, 2026, we had income from continuing operations of $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 $3.38, for the same period a year ago, and for the six months ended June 30, 2026, we had a loss from continuing operations of $3.2 million, or a loss per basic and diluted share of $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 gain on deconsolidation of subsidiary, offset by increases in operating costs and expenses and decreases in revenue. Cash and cash equivalents, investments and accounts receivable totaled $95.7 million at June 30, 2026, a decrease of $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. Commercial, Development and Research Programs The following is an overview of our clinical, commercial, and research programs. FG-3246 and FG-3180 in mCRPC Disease Overview Prostate cancer is the second most common malignancy in men, contributing significantly to male mortality rates. Approximately 13% of men will be diagnosed with prostate cancer at some point during their lifetime. In any given year, there are approximately 65,000 drug treatable mCRPC cases in the U.S. across the various lines of therapy, and 5-year survival in mCRPC is approximately 30%. Current Standard of Care Treatment choice in first and second line mCRPC significantly depends on patients’ prior treatments in the castration sensitive phase. Androgen receptor signaling inhibitors or androgen receptor pathway inhibitors (“ARSIs” / “ARPIs,” often used interchangeably) and chemotherapy are the preferred treatments in patients who have not been exposed to either in earlier lines of therapy. Most patients who previously progressed on an ARPI will subsequently receive chemotherapy. Switching to another ARPIs is another option for these patients but this approach is generally associated with suboptimal outcomes. For the 25-30% of patients with homologous recombination repair mutation (“HRRm”), poly (ADP-ribose) polymerase PARP inhibitors are the standard of care for mCRPC patients. The recent approval of prostate-specific membrane antigen (“PSMA”)-targeted radiopharmaceutical Pluvicto (lutetium Lu 177 vipivotide tetraxetan) in the post-ARPI and pre-chemotherapy setting has diversified treatment options in first and second line mCRPC for PSMA positive patients. Furthermore, PSMA-PET has been validated as standard of care diagnostic in prostate cancer, while LOCAMETZ or an approved PSMA-11 imaging agent are approved to select patients for treatment with Pluvicto. 24 Table of Contents Kyntra Bio is developing FG-3246 in the post-ARPI, pre-chemotherapy mCRPC setting. This is an area of high unmet need, where radiographic progression free survival is short: Approximately 5-6 months after switching to a different ARPI, approximately 8 months with chemotherapy, and 9.3 months with Pluvicto in PSMA-positive patients, who are considered appropriate to delay taxane-based chemotherapy. Novel mechanisms of action that extend survival are critical in this setting as well as biomarker driven treatment approaches. FG-3246 and the potential patient selection biomarker FG-3180 are being developed to address these unmet medical needs. Phase 2 Monotherapy Clinical Trial of FG-3246 and FG-3180 for the Treatment of mCRPC We are developing FG-3246 in mCRPC. FG-3246 is a potential first-in-class ADC targeting CD46, a novel epitope expressed on the surface of prostate and other cancer cells. In addition to CD46 being expressed at high levels in certain tumor types with limited expression in most normal tissues, CD46 is a cell receptor that induces internalization upon antibody binding, which makes it an ideal target for an ADC . The cytotoxic payload of FG-3246 is monomethyl auristatin E (“MMAE”), an anti-mitotic agent that has been utilized in four commercially approved ADC drugs. We are actively enrolling our Phase 2 monotherapy dose optimization study of FG-3246 for the treatment of patients with mCRPC in the post-ARPI and pre-chemotherapy setting, with interim results expected in the fourth quarter of 2026. The trial is also assessing the diagnostic and predictive performance of FG-3180, a companion PET imaging agent, which shares the same CD46-targeted antibody used in FG-3246. The ability of FG-3180 to identify mCRPC lesions and predict response to FG-3246 is being evaluated . Our ongoing Phase 2 monotherapy trial ( NCT06842498 ) is a randomized, open label, dose optimization trial designed to evaluate the safety, efficacy, tolerability, and pharmacokinetics (PK) of FG-3246 for the treatment of patients with mCRPC who have progressed following ARPI treatment and who have not received chemotherapy for their mCRPC. The trial is scheduled to enroll 75 patients who will be randomized 1:1:1 to receive either 1.8, 2.4 or 2.7 mg/kg AJBW of FG-3246. The primary endpoint of the trial is the determination of the optimal dose for the Phase 3 trial based on efficacy, safety, and PK parameters. Secondary endpoints include radiographic progression-free survival (“rPFS”), prostate-specific antigen (“PSA”) 50 response, and PSA90 response. An interim analysis, made up of a composite response rate of PSA50 response and overall response rate, is currently planned once 12 patients enrolled in each of the three dose arms have completed up to 12 weeks on study or discontinued and is anticipated in the fourth quarter of 2026. An exploratory sub-study is evaluating 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. Prior Studies of FG-3246 and FG-3180 for the Treatment of mCRPC In March 2025, Kyntra Bio announced the peer-reviewed publication titled “A Phase 1, First-in-Human Study of FOR46 (FG-3246), an Immune-Modulating Antibody-Drug Conjugate Targeting CD46, in Patients with Metastatic Castration Resistant Prostate Cancer” in the Journal of Clinical Oncology. The manuscript included the complete results from the Fortis Therapeutics, Inc. (“Fortis”)-sponsored Phase 1 study of FG-3246 in heavily-pretreated, biomarker un-selected patients with mCRPC. Key efficacy highlights observed in the RECIST-evaluable set of 25 patients include: (1) confirmed objective response rate was 20% with median duration of response of 7.5 months, (2) all objective responses observed at a starting dose of 2.7 mg/kg or higher, and (3) disease control rate was 80% with duration of treatment exceeding 24 weeks in 12 patients (48%); (4) PSA50 response rate of 36% in 39 evaluable patients (of eight evaluable patients who received docetaxel in the castration-sensitive setting, four (50%) achieved a confirmed PSA50 response); (5) median radiographic progression-free survival of 8.7 months in all 40 subjects in the efficacy analysis set; (6) of 15 evaluable baseline tumors, 12 (80%) were positive for CD46 expression by immunohistochemistry; and (7) FG-3246 responders were found to have a significantly higher frequency of effector T cells and lower frequency of immunosuppressive myeloid cells. In February 2026, the University of California, San Francisco (“UCSF”) presented positive results from the investigator-sponsored Phase 1b/2 study of FG-3246 in combination with enzalutamide in patients with mCRPC at the 2026 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU). The presentation includes data from 44 biomarker unselected patients with progressive mCRPC, 17 of which were enrolled in the Phase 1b dose escalation portion of the study with 27 enrolled in the dose expansion phase of the study. Eligibility criteria for the trial included patients who progressed on at least one prior ARPI while patients who were treated with prior chemotherapy in the castration-resistant setting were excluded. Over 60% of the patients progressed on two or more prior ARPIs prior to enrollment, which included prior enzalutamide treatment. The primary endpoint of the escalation phase was assessment of dose-limiting toxicities (“DLT”) and determination of the maximum tolerated dose and recommended dose for the Phase 2 portion of the study – which was determined to be 2.1 mg/kg of FG-3246 and 160mg/day of 25 Table of Contents enzalutamide. The primary endpoint of the Phase 2 expansion portion of the study was composite response rate (PSA50 response and/or objective response per RECIST v1.1). Secondary endpoints were PSA50 response rate, objective response rate, rPFS, overall survival, and treatment-related adverse events (“TRAEs”). FG-3246 combined with enzalutamide demonstrated anti-tumor activity with a composite response rate of 21% in the overall cohort and 40% in patients who had progressed on only one prior ARPI. Median rPFS of 7.0 months was observed in the overall cohort. Notably, median rPFS of 10.1 months was observed in patients who had progressed on only one prior ARPI, a result which was consistent across the different prior ARPIs administered. Additionally, in an exploratory analysis, tumor uptake of FG-3180 (our CD46-targeting PET imaging agent) was numerically associated with PSA50 response (nominal p=0.053), highlighting its potential as a biomarker for patient selection. Combination therapy of FG-3246 and enzalutamide demonstrated a similar safety profile as was observed in the previous Phase 1 monotherapy trial of FG-3246. Neutropenia risk was successfully mitigated with use of granulocyte colony-stimulating factor (“G-CSF”) prophylaxis. The most frequent TRAEs with the combination therapy included fatigue, peripheral neuropathy, anorexia, and dysgeusia. Cumulative toxicities, including peripheral neuropathy, led to treatment discontinuation for some patients. ROXADUSTAT IN ANEMIA ASSOCIATED WITH MDS Disease Overview MDS are a diverse group of bone marrow disorders characterized by ineffective production of healthy blood cells and premature destruction of blood cells in the bone marrow, leading to anemia. In most MDS patients, the cause of the disease is unknown. The diagnosed prevalence of MDS in the U.S. is estimated to be approximately 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 20,000 adults in the U.S., 70% of whom are considered lower-risk MDS. Anemia is the most common clinical presentation in MDS, seen in approximately 80% of MDS patients, and produces symptoms of fatigue, weakness, exercise intolerance, shortness of breath, dizziness, and cognitive impairment. Limitations of the Current Standard of Care for Anemia in MDS Stem cell transplantation is the only potentially curative therapy for MDS, but it is not feasible in most patients due to their advanced age and frailty. The high rate of severe anemia leaves recurring red blood cell (“RBC”) transfusions as the mainstay of care in MDS patients. Transfusion can result in direct organ damage through transfusional iron overload. Transfusion-dependent MDS patients suffer higher rates of cardiac events, infections, and transformation to acute leukemia, a decreased overall survival rate when compared with non-transfused patients with MDS, and decreased survival compared to an age-matched elderly population. Patients receiving RBC transfusions may require an iron chelator in order to address toxic elements of iron overload such as lipid peroxidation and cell membrane, protein, DNA, and organ damage. Lower-risk MDS patients represent approximately 77% of the total diagnosed MDS population. National Comprehensive Cancer Network guidelines recommend the use of ESAs, luspatercept and imetelstat in lower risk MDS patients, depending on patients’ treatment history, serum erythropoietin (“EPO”) levels and ring sideroblast status . Currently available treatment options are effective in only ~50% patients, are challenging to dose-calibrate and can only be administered via subcutaneous injection or through IV infusion. New strategies that provide durable response and the convenience of oral administration are highly desired in managing patients with lower-risk MDS. 26 Table of Contents Market Opportunity for Roxadustat in MDS We believe there is a significant need for a safe and convenient option to address anemia in patients with lower-risk MDS that is effective agnostic of ring sideroblast status. Roxadustat, our orally administered small molecule hypoxia-inducible factor prolyl hydroxylase inhibitor, stimulates the body’s natural mechanism of RBC production and iron hemostasis based on cellular-level oxygen-sensing and iron-regulation mechanisms. Unlike ESAs which are limited to providing exogenous EPO, roxadustat activates a coordinated erythropoietic response in the body that includes the stimulation of RBC progenitors, an increase in the body’s production of endogenous EPO, and an increase in iron availability for hemoglobin synthesis, which we believe is important in a broad range of lower-risk MDS patients. Moreover, in anemia of CKD, roxadustat has demonstrated the ability in clinical trials to increase and maintain hemoglobin levels in the presence of inflammation as measured by C-reactive protein (“CRP”), where ESAs have shown limited effect. We believe that roxadustat has the potential to replicate this result in lower-risk MDS anemia patients, where it is not uncommon for patients to present with autoimmune and inflammatory conditions. According to Grand View Research, the global MDS market was estimated at approximately $3 billion in 2023 and is projected to reach approximately $5 billion by 2030 (approximately 9% CAGR from 2024 to 2030), attributed primarily to the rise in novel therapeutics. Roxadustat in MDS Clinical Trials We maintain our rights to roxadustat in the U.S., Canada, Mexico and in all markets not licensed to Astellas or held by AstraZeneca. We had a positive Type-C meeting with the FDA in July 2025, and reached alignment on several elements of our proposed Phase 3 study design for roxadustat in anemia associated with lower-risk MDS, including the starting dose and the patient inclusion criteria. We have finalized 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 FDA granted roxadustat Orphan Drug Designation for the treatment of MDS in December 2025. If roxadustat is approved for lower-risk MDS, Orphan Drug Designation would provide seven years regulatory exclusivity for roxadustat in lower-risk MDS in the U.S., along with additional economic and other benefits associated with Orphan Drug Designation. 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 agent (ESA) therapy), dose regimen, and 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 the study. The FDA recommended a longer duration of TI as the primary endpoint (16-weeks over 48 weeks), however, an 8-week primary endpoint is 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. Phase 2/3 Clinical Trial in MDS Topline 28-week data from MATTERHORN, our Phase 2/3 placebo-controlled, double-blind clinical trial of roxadustat for the treatment of anemia in MDS, was presented in the fourth quarter of 2023 at the American Society of Hematology annual conference. As previously disclosed, more patients in the roxadustat arm (47.5% of 80 patients) achieved transfusion independence for 56 consecutive days (within the first 28 weeks) than the placebo arm (33.3% of 57 patients); however, the p-value was not significant. Our European Hematology Association (EHA) Congress 2026 presentation highlighted data from a post hoc analysis of the entire trial population, demonstrating that roxadustat led to similar rates of transfusion independence in both RS+ and RS - patients. In RS - patients, which comprised 84 of the 140 patients enrolled in the trial, treatment with roxadustat led to transfusion independence for ≥8 weeks (within the first 28 weeks) in 48% of patients vs. 28% for placebo. 27 Table of Contents In the 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 (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. Roxadustat in Anemia of CKD We and our collaboration partners developed roxadustat (爱瑞卓 ® , EVRENZO TM ), which is currently approved in China, Europe, Japan, and numerous other countries for the treatment of anemia in CKD patients on dialysis and not on dialysis. China – Roxadustat Commercial Program On August 29, 2025, we closed the sale of our China operations through FibroGen International to AstraZeneca Treasury Limited pursuant to 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. This sale included all of our roxadustat assets in China, including FibroGen International’s subsidiary FibroGen Beijing and its 51.1% interest in Falikang. For additional details, refer to Note 3, Discontinued Operations and Divestiture, to the condensed consolidated financial statements . U.S., Europe, Japan and Rest of World - Roxadustat Program Kyntra Bio has retained the rights to roxadustat in the U.S., Canada, Mexico, and in all markets not held by AstraZeneca or licensed to Astellas. Astellas is commercializing roxadustat (EVRENZO TM ) 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. Exclusive License and Option to Acquire Fortis In May 2023, we entered into an exclusive option agreement to acquire Fortis with its novel Phase 1 ADC, FOR46 (now referred to as “FG-3246”) that targets CD46, a novel epitope preferentially expressed on certain cancer cells. FG-3246 is in development for the treatment of mCRPC with potential applicability in other solid tumors and hematologic malignancies. Pursuant to an evaluation agreement entered into with Fortis concurrent with the option agreement, Kyntra Bio has exclusively licensed FG-3246 and will control and fund future research and development, including a Phase 2 clinical study sponsored by Kyntra Bio, and manufacturing of FG-3246 during the option period (which ends on December 31, 2027). As part of the clinical development strategy, we will continue the work to develop a PET-based biomarker utilizing a radiolabeled version of the targeting antibody for patient selection. If we exercise the option to acquire Fortis, we will pay Fortis $80.0 million, and thereafter, Fortis would be eligible to receive from Kyntra Bio up to $200.0 million in contingent payments associated with the achievement of various regulatory approvals. If we acquire Fortis, we would also be responsible to pay UCSF, an upstream licensor to Fortis, development milestone fees and a single digit royalty on net sales of therapeutic or diagnostic products arising from the collaboration. If Kyntra Bio chooses not to acquire Fortis, its exclusive license to FG-3246 would expire. 28 Table of Contents Collaboration Partnerships for Roxadustat Our current and future research, development, manufacturing and commercialization efforts with respect to roxadustat depend on funds from our collaboration agreements with Astellas and AstraZeneca. See Note 4, Collaboration Agreements, License Agreement and Revenues , to the condensed consolidated financial statements for details. Astellas 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 June 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 $(2.9) 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 six months ended June 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 $1.4 million and $1.2 million for the three months ended June 30, 2026 and 2025, and $7.0 million and $2.0 million for the six months ended June 30, 2026 and 2025, respectively. AstraZeneca 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 other territories not 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 us in support of commercial supplies. In February 2024, we entered into an agreement to terminate the AstraZeneca U.S./RoW Agreement with AstraZeneca, as amended and restated on August 29, 2025. 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 July 2013, through our China subsidiary and related affiliates, we entered into a collaboration agreement with AstraZeneca for roxadustat for the treatment of anemia in China (the “AstraZeneca China Agreement”). On August 29, 2025, we closed the sale of our China operations through FibroGen International to AstraZeneca Treasury Limited pursuant to the Share Purchase Agreement. For additional details, refer to Note 3, Discontinued Operations and Divestiture, to the condensed consolidated financial statements. Under the AstraZeneca China Agreement, the aggregate amount of consideration received through the sale of our China operations totaled $81.2 million. In July 2020, FibroGen China and AstraZeneca entered into an amendment to the AstraZeneca China Agreement, relating to the development and commercialization of roxadustat in China (the “AstraZeneca China Amendment”). Accordingly, in 2020, FibroGen Beijing and AstraZeneca completed the establishment of a jointly owned entity, Falikang, which performs roxadustat distribution, as well as conducts sales and marketing through AstraZeneca. We accounted for our investment in Falikang under the equity method, and Falikang was not consolidated into our consolidated financial statements. Our proportionate share of the reported profits or losses of Falikang, was included in the discontinued operations in the condensed consolidated statement of operations. See Note 3, Discontinued Operations and Divestiture , to the condensed consolidated financial statements for details. 29 Table of Contents Product revenue, net, was $19.7 million and $59.5 million for the three and six months ended June 30, 2025, respectively, majority of which were from the sales to Falikang, and was included in the discontinued operations. As discussed in Note 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. RESULTS OF OPERATIONS Revenue Three Months Ended June 30, Change Six Months Ended June 30, Change 2026 2025 $ % 2026 2025 $ % (dollars in thousands) Revenue: Development and other revenue $ 103 $ 133 $ (30 ) (23 ) % $ 349 $ 277 $ 72 26 % Drug product revenue, net (1,577 ) 1,215 (2,792 ) (230 ) % 1,915 3,811 (1,896 ) (50 ) % Total revenue $ (1,474 ) $ 1,348 $ (2,822 ) (209 ) % $ 2,264 $ 4,088 $ (1,824 ) (45 ) % 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 June 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. Drug product revenue includes commercial-grade API or bulk drug product sales to Astellas in support of pre-commercial preparation prior to the new drug application or marketing authorization application approval, and for ongoing commercial launch in Japan and Europe. We recognize drug product revenue when we fulfill the inventory transfer obligations. The amount of variable consideration that is included in the transaction price may be constrained, and is included in the drug product revenue only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period when the uncertainty associated with the variable consideration is subsequently resolved. Actual amounts of consideration ultimately received in the future may differ from our estimates, for which we will adjust these estimates and affect the drug product revenue in the period such variances become known. 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. Total revenue decreased $2.8 million, or 209%, for the three months ended June 30, 2026, and decreased $1.8 million, or 45%, for the six months ended June 30, 2026, respectively, compared to the same periods a year ago for the reasons discussed in the sections below. Drug Product Revenue, Net Three Months Ended June 30, Change Six Months Ended June 30, Change 2026 2025 $ % 2026 2025 $ % (dollars in thousands) Drug product revenue, net: Astellas Japan Agreement $ (2,935 ) $ 44 $ (2,979 ) (6,770 ) % $ (5,126 ) $ 1,825 $ (6,951 ) (381 ) % Astellas Europe Agreement 1,358 1,171 187 16 % 7,041 1,986 5,055 255 % Total drug product revenue, net: $ (1,577 ) $ 1,215 $ (2,792 ) (230 ) % $ 1,915 $ 3,811 $ (1,896 ) (50 ) % Drug product revenue, net decreased $2.8 million, or (230)%, for the three months ended June 30, 2026, and decreased $1.9 million, or 50%, for the six months ended June 30, 2026, respectively, compared to the same periods a year ago. 30 Table of Contents Astellas Japan Agreement During the second quarter of 2026, we updated our estimate of variable consideration related to the API shipments fulfilled under the terms of Astellas Japan Amendment, and accordingly recorded a reduction to the drug product revenue of $2.9 million. Specifically, the change in estimated variable consideration was based on the API held by Astellas at period end, adjusted to reflect changes in the estimated bulk product strength mix intended to be manufactured by Astellas, and foreign exchange impacts, among others. During the first quarter of 2026, we updated our estimate of variable consideration related to the API shipments fulfilled under the terms of Astellas Japan Amendment, and accordingly recorded a reduction to the drug product revenue of $2.2 million. Specifically, the change in estimated variable consideration was based on the API held by Astellas at period end, adjusted to reflect changes in the listed price, among others. During the second quarter of 2025, the adjustment to the drug product revenue was immaterial. During the first quarter of 2025, we updated our estimate of variable consideration related to the API shipments fulfilled under the terms of Astellas Japan Amendment, and accordingly recorded an adjustment to the drug product revenue of $1.8 million. Specifically, the change in estimated variable consideration was based on the API held by Astellas at period end, adjusted to reflect the changes in the estimated yield from the manufacture of bulk product tablets, among others. As of June 30, 2026, the balances related to the API price true-up under the Astellas Japan Agreement were $2.9 million in accrued liabilities, representing our best estimate of the timing for these amounts to be paid. Astellas Europe Agreement We recognized royalty revenue as drug product revenue, from the deferred revenue under the Astellas Europe Agreement, of $1.4 million and $1.2 million for the three months ended June 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 when uncertainty is resolved, based on the performance of roxadustat product sales in the Astellas territory. During the first quarter of 2026, we recorded $3.3 million to the drug product revenue for intermediates under the terms of the Astellas Europe Agreement and the Astellas EU Supply Agreement, and received cash during the same quarter. In addition, we transferred bulk drug product for commercial purposes under the terms of the Astellas Europe Agreement and the Astellas EU Supply Agreement, and recognized the related fully-burdened manufacturing costs of $0.9 million as drug product revenue, and recorded $6.2 million as deferred revenue due to a high degree of uncertainty associated with the variable consideration for revenue recognition purposes. For the six months ended June 30, 2026, we updated our estimate of variable consideration related to the bulk drug product transferred in prior years. Specifically, the change in estimated variable consideration was based on the bulk drug product held by Astellas at the period end, adjusted to reflect the changes in the estimated transfer price, forecast information, shelf-life estimates and other items. As a result, we further reclassified $0.8 million from the related deferred revenue to accrued liabilities. As of June 30, 2026, the balances related to the bulk drug product price true-up under the Astellas Europe Agreement and the Astellas EU Supply Agreement were $2.3 million in accrued liabilities, representing our best estimate that these amounts will be paid within the next 12 month. As of December 31, 2025, we recorded $5.4 million related balance in accrued liabilities, $3.8 million of which was paid to Astellas in the first quarter of 2026. Operating Costs and Expenses Three Months Ended June 30, Change Six Months Ended June 30, Change 2026 2025 $ % 2026 2025 $ % (dollars in thousands) Operating costs and expenses Cost of goods sold $ 2 $ 85 $ (83 ) (98 ) % $ 4,108 $ 337 $ 3,771 1,119 % Research and development 6,821 5,865 956 16 % 14,387 15,040 (653 ) (4 ) % Selling, general and administrative 9,266 7,057 2,209 31 % 15,128 15,164 (36 ) — % Restructuring charge 11 393 (382 ) (97 ) % 33 519 (486 ) (94 ) % Total operating costs and expenses $ 16,100 $ 13,400 $ 2,700 20 % $ 33,656 $ 31,060 $ 2,596 8 % 31 Table of Contents Total operating costs and expenses increased $2.7 million, or 20%, for the three months ended June 30, 2026, and increased $2.6 million, or 8%, for the six months ended June 30, 2026, respectively, compared to the same periods a year ago for the reasons discussed in the sections below. Cost of Goods Sold Cost of goods sold for the three months ended June 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 six months ended June 30, 2026. Research and Development Expenses 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. The following table summarizes our research and development expenses incurred during the three and six months ended June 30, 2026 and 2025: Phase of Three Months Ended June 30, Six Months Ended June 30, Product Candidate Development 2026 2025 2026 2025 (in thousands) FG-3246 Phase 2 $ 4,753 $ 3,511 $ 9,076 $ 8,781 Roxadustat Approved / Phase 3 2,041 1,105 4,683 1,562 Other research and development expenses 27 1,249 628 4,697 Total research and development expenses $ 6,821 $ 5,865 $ 14,387 $ 15,040 The program-specific expenses summarized in the table above include costs we directly attribute to our product candidates. We allocate research and development salaries, benefits, stock-based compensation and other indirect costs to our product candidates on a program-specific basis, and we include these costs in the program-specific expenses. Research and development expenses increased $1.0 million, or 16%, for the three months ended June 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 $0.8 million employee-related costs primarily due to lower headcount. Research and development expenses decreased $0.7 million, or 4%, for the six months ended June 30, 2026, compared to the same period a year ago, primarily as a result of the net effect of the following: • Decrease of $1.9 million employee-related costs primarily due to lower headcount; • Decrease of $1.1 million in stock-based compensation primarily resulting from lower stock price and reduced headcount; • Decrease of $0.8 million in drug development expenses due to lower drug substance activities and lower logistic expenses associated with manufacturing activities for FG-3246 clinical trials; • Increase of $2.1 million in clinical trials expenses associated with FG-3246 Phase 2 trials; and • Increase of $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. 32 Table of Contents Selling, General and Administrative Expenses 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. SG&A expenses increased $2.2 million, or 31%, for the three months ended June 30, 2026, compared to the same period a year ago, primarily as a result of the net effect of the following, respectively: • Increase of $3.5 million in legal expenses primarily related to estimated indemnification costs associated with a former officer; and • Decrease of $0.7 million in equipment and facilities-related expenses due to cost control efforts. SG&A expenses remained relatively flat for the six months ended June 30, 2026, compared to the same period a year ago, primarily as a result of the net effect of the following, respectively: • Increase of $4.3 million in legal expenses primarily related to estimated indemnification costs associated with a former officer; • Decrease of $1.8 million in equipment and facilities-related expenses and decrease of $1.1 million in outside services due to cost control efforts; • Decrease of $0.6 million in audit services due to lower audit activities; and • Decrease of $0.5 million in stock-based compensation primarily resulting from lower stock price and reduced headcount. Interest and Other, Net Three Months Ended June 30, Change Six Months Ended June 30, Change 2026 2025 $ % 2026 2025 $ % (dollars in thousands) Interest and other, net: Interest expense $ (2,368 ) $ (2,009 ) $ (359 ) 18 % $ (4,795 ) $ (4,265 ) $ (530 ) 12 % Gain on deconsolidation of subsidiary 30,940 — 30,940 NM 30,940 — 30,940 NM Interest income and other income (expenses), net 975 286 689 241 % 2,088 698 1,390 199 % Total interest and other, net $ 29,547 $ (1,723 ) $ 31,270 (1,815 ) % $ 28,233 $ (3,567 ) $ 31,800 (892 ) % ________________________ NM = Not meaningful Interest Expense Interest expense represents the interest related to sale of future revenues and interest related to the Technology Development Center of the Republic of Finland product development obligations. Interest expense remained relatively flat for the three and six months ended June 30, 2026, compared to the same periods a year ago. Gain on deconsolidation of subsidiary In April 2026, our subsidiary, FibroGen Europe, voluntarily filed for bankruptcy with the Finnish bankruptcy court. On April 16, 2026, the Helsinki District Court declared FibroGen Europe bankrupt and appointed an estate administrator to oversee the bankruptcy estate. As a result, we determined that we no longer maintained a controlling financial interest in FibroGen Europe and therefore deconsolidated the subsidiary effective April 16, 2026. Upon deconsolidation, we derecognized the subsidiary’s assets and liabilities and recognized a $30.9 million gain on deconsolidation. See Note 2, Deconsolidation of European Subsidiary , to the condensed consolidated financial statements for details. 33 Table of Contents Interest Income and Other Income (Expenses), Net Interest income and other income (expenses), net primarily include interest income earned on our cash, cash equivalents and investments, foreign currency transaction gains (losses), remeasurement of certain monetary assets and liabilities in non-functional currency of our subsidiaries into the functional currency, realized gains (losses) on sales of investments, and other non-operating income and expenses. Interest income and other income (expenses), net increased $0.7 million, or 241%, and increased $1.4 million, or 199%, for the three and six months ended June 30, 2026, respectively, compared to the same periods a year ago, primarily due to higher interest income resulting from overall higher cash equivalents and investment balances during the current year periods. Income Taxes Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 (dollars in thousands) Income (loss) from continuing operations before income taxes $ 11,973 $ (13,775 ) $ (3,159 ) $ (30,539 ) Benefit from income taxes (1 ) (92 ) (1 ) (90 ) Effective tax rate — % 0.7 % — % 0.3 % Benefit from income taxes for the three and six months ended June 30, 2026 and 2025 were immaterial. Based upon the weight of available evidence, which includes our historical operating performance, reported cumulative net losses since inception and expected continuing net loss, we have established a full valuation allowance against our net deferred tax assets as we do not currently believe that realization of those assets is more likely than not. Discontinued Operations On February 20, 2025, we entered into the Share Purchase Agreement with AstraZeneca Treasury Limited pursuant to which we and our subsidiary FibroGen China Anemia Holdings, Ltd. agreed to sell all of the issued and outstanding equity interests of FibroGen International to AstraZeneca Treasury Limited. This sale includes all of our roxadustat assets in China, including FibroGen International’s subsidiary FibroGen Beijing and its 51.1% interest in Falikang. The transaction was closed on August 29, 2025. We determined that FibroGen International met the “held for sale” criteria and the “discontinued operations” criteria in accordance with Financial Accounting Standard Board Accounting Standards Codification ASC 205, Presentation of Financial Statements , as of December 31, 2024. Accordingly, the operating results related to FibroGen International are classified as discontinued operations, and have been reflected as discontinued operations in the condensed consolidated statements of operations. See Note 3, Discontinued Operations and Divestiture , to the condensed consolidated financial statements for details. 34 Table of Contents LIQUIDITY AND CAPITAL RESOURCES Financial Condition We have historically funded our operations principally from the sale of common stock (including our public offering proceeds), from the execution of collaboration agreements involving license payments, milestone payments, reimbursement for development services, and the associated product revenue and drug product revenue. Upon the close of the sale of FibroGen International and its subsidiaries to AstraZeneca Treasury Limited on August 29, 2025, we received $210.4 million in cash paid at closing, and a total of $10.0 million cash payable by AstraZeneca at the closing subject to holdbacks of: (i) a $6.0 million holdback to offset final net cash adjustments which will be released following a customary adjustment process approximately 90 days post-closing (as such time may be extended for the parties to mutually agree upon final adjustments), and (ii) a $4.0 million holdback to satisfy any indemnity claims, which will be released, net of any claims paid or unresolved, nine months after the closing. On November 6, 2025, we received a $6.4 million payment from AstraZeneca, which is in full satisfaction of the first holdback of $6.0 million, plus $0.4 million that was an additional payment following the final net cash adjustments after closing. On June 2, 2026, we received a $4.0 million payment from AstraZeneca, which is in full satisfaction of the final holdback. See Note 3, Discontinued Operations and Divestiture , to the condensed consolidated financial statements for details. In April 2023, we entered into the Financing Agreement with investment funds managed by MSTV (“Lenders”), and Wilmington Trust, National Association, as the administrative agent, providing for senior secured term loan facilities consisting of a $75.0 million initial term loan. Upon the closing of the sale of FibroGen International and its subsidiaries to AstraZeneca Treasury Limited on August 29, 2025, we repaid our term loan facility with the Lenders. For additional details about this financing transaction, see Note 7, Senior Secured Term Loan Facilities , to the condensed consolidated financial statements. In November 2022, we entered into a Revenue Interest Financing Agreement (“RIFA”) with an affiliate of NovaQuest Capital Management (“NovaQuest”) with respect to our revenues from Astellas’ sales of roxadustat in Europe, Japan and the other Astellas territories. Pursuant to the RIFA, in the fourth quarter of 2022, we received $49.8 million from NovaQuest, representing the gross proceeds of $50.0 million net of initial issuance costs, in consideration for a portion of future revenues we will receive from Astellas. For additional details about this financing transaction, see Note 8, Liability Related to Sale of Future Revenues , to the condensed consolidated financial statements. In February 2025, we entered into an Equity Distribution Agreement with BofA Securities, Inc. pursuant to which we may issue and sell, from time to time and through BofA Securities, Inc., shares of our common stock having an aggregate offering price of up to $30.0 million. We did not sell any shares of common stock under this agreement to date. As previously disclosed, in April 2026, we received a letter from the Nasdaq Listing Qualifications Staff of the Nasdaq Stock Market notifying us that Kyntra Bio no longer complies with the Nasdaq Global Select Market continued listing requirement of $50 million in total assets and total revenue for the most recently completed fiscal year (or two of the last three most recently completed fiscal years) per Listing Rule 5450(b)(3)(A). This is due to the revenue of FibroGen International being presented as held for sale (in discontinued operations) in our 2024 and 2025 10-Ks. The notification has no immediate effect on the listing of Kyntra Bio’s common stock on Nasdaq Global Select Market. Kyntra Bio timely submitted a compliance plan to Nasdaq. Kyntra Bio may also consider applying to transfer our securities to the Nasdaq Capital Market. If we are unable to maintain compliance or transfer and regain compliance, our common stock could become subject to delisting, which could adversely affect share price, liquidity, and ability to raise capital. Cash and cash equivalents, investments and accounts receivable totaled $95.7 million at June 30, 2026, compared to $109.4 million as of December 31, 2025. Cash is invested in accordance with our investment policy, primarily with a view to liquidity and capital preservation. Investments, consisting of available-for-sale securities, and stated at fair value, are also available as a source of liquidity. Our liquidity is subject to specific risks, including: (i) indemnification obligations to current and former officers and directors, which may require us to advance legal expenses or satisfy judgments or settlements that are not fully covered by insurance, as our insurance policies are subject to exclusions, coverage limits, and potential disputes with insurers; and (ii) our obligations under the RIFA with NovaQuest, pursuant to which we may be required to make substantial payments if the revenue interest payments do not perform sufficiently, including potential balloon payments in 2029 and 2031, which could place significant demands on our cash resources relative to our current liquidity position. 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. 35 Table of Contents Cash Sources and Uses The following table sets forth the primary sources and uses of cash and cash equivalents for each of the periods set forth below (in thousands), including both continuing operations and discontinued operations: Six Months Ended June 30, 2026 2025 Net cash provided by (used in): Operating activities $ (17,878 ) $ 15,401 Investing activities 20,691 (29 ) Financing activities (12 ) (97 ) Effect of exchange rate changes on cash and cash equivalents (29 ) 2,388 Net increase in cash and cash equivalents $ 2,772 $ 17,663 Operating Activities Net cash used in operating activities was $17.9 million for the six months ended June 30, 2026 and consisted primarily of net loss of $3.2 million adjusted for non-operating cash items of $29.0 million, and a net increase in operating assets and liabilities of $14.4 million. The significant non-operating cash items included gain on deconsolidation of subsidiary of $30.9 million and stock-based compensation expense of $2.1 million. The significant items in the changes in operating assets and liabilities included the following: • Accrued and other liabilities increased $4.0 million, driven by higher accrued legal expenses; • Accounts payable increased $3.8 million driven by timing of invoicing and payments; • Accrued interest expense related to sale of future revenues increased $3.4 million due to the interest expense of $4.7 million accrued, offset by the interest payment of $1.3 million during the period. See Note 8, Liability Related to Sale of Future Revenues , to the condensed consolidated financial statements for details; and • Deferred revenue increased $2.5 million, driven by $6.2 million associated with the bulk drug product transferred to Astellas under the terms of the Astellas Europe Agreement and the Astellas EU Supply Agreement during the six months ended June 30, 2026; partially offset by $2.8 million royalty revenue recognized, and $0.8 million reclassified to accrued liabilities, resulting from changes in estimated variable consideration associated with the bulk drug product transferred to Astellas. See the Drug Product Revenue, Net section in Note 4, Collaboration Agreements, License Agreement and Revenues , to the condensed consolidated financial statements for details. Net cash provided by operating activities was $15.4 million for the six months ended June 30, 2025 and consisted primarily of net loss of $3.0 million adjusted for non-operating cash items of $6.2 million, and a net increase in operating assets and liabilities of $12.1 million. The significant non-operating cash items included stock-based compensation expense of $4.7 million. The significant items in the changes in operating assets and liabilities included the following: • Prepaid expenses and other current assets decreased $51.5 million, primarily due to the $28.5 million distribution of the above-mentioned litigation settlement during the quarter, which is fully recoverable under our insurance policies. The decrease in prepaid expenses and other current assets was also related to the collection from Falikang during the quarter based on the arrangements under the settlement agreements between FibroGen China and AstraZeneca to settle certain historical items, which was unbilled receivables as of December 31, 2024; • Deferred revenue increased $7.5 million, primarily related to the $10.0 million additional deferred revenue during the quarter due to changes in estimate associated with the China performance obligation; offset by the $2.0 million royalty revenue recognized from the deferred revenue under the Astellas Europe Agreement during the period; • Inventory decreased $4.2 million primarily driven by lower inventory production in China as we have decommissioned our API manufacturing facility in Cangzhou, China in late 2024; • Accrued interest expense related to sale of future revenues increased $3.7 million due to the interest expense of $4.1 million accrued, offset by the interest paid of $0.5 million during the period; • Accrued and other liabilities decreased $30.7 million, primarily driven by the $28.5 million distribution of litigation settlement related to our agreement in principle with plaintiffs to settle the class action lawsuit. The accrued and other liabilities were also impacted by cost control efforts and the timing of invoicing and payment; 36 Table of Contents • Accounts payable decreased $21.7 million, primarily driven by the payments made during the quarter to AstraZeneca under the settlement agreements entered in September 2024 between FibroGen China and AstraZeneca to settle certain historical items; and • Accounts receivable increased $3.0 million, primarily driven by the billings to Falikang based on the arrangements under the above-mentioned settlement agreements and related to the increase product sales. Investing Activities Investing activities primarily consist of purchases of investments, proceeds from the maturity and sale of investments, and net proceeds from divestiture. Net cash provided by investing activities was $20.7 million for the six months ended June 30, 2026 and consisted primarily of $31.8 million proceeds from maturity of investments and $4.0 million cash payment received from AstraZeneca, which is in full satisfaction of the final holdback related to divestiture of FibroGen International; partially offset by $15.0 million cash used in purchases of available-for-sale securities. Net cash used in investing activities was immaterial for the six months ended June 30, 2025. Financing Activities Financing activities primarily reflect proceeds from strategic financing arrangements, cash paid for payroll taxes on restricted stock unit releases, and repayments of our lease liabilities and obligations. Net cash used in financing activities was immaterial for the six months ended June 30, 2026 and 2025, respectively. Material Cash Requirements We generate revenue from commercial sales of roxadustat product in Japan and Europe. Even with these revenues, we anticipate that we will continue to generate losses for the foreseeable future. To date, we have funded certain portions of our research and development and manufacturing efforts globally through collaboration partners, debt financings, and equity financing. We expect to continue to incur significant research and development expenses to invest in our development programs and there is no guarantee that sufficient funds will be available to continue to fund these development efforts through commercialization or otherwise. We are also subject to all the risks related to the development and commercialization of novel therapeutics, and we may encounter unforeseen expenses, difficulties, complications, delays and other factors outlined under Part II, Item 1A “ Risk Factors ” in this Quarterly Report on Form 10-Q, as well as unknown factors that may adversely affect our business. We anticipate that we will need substantial additional funding in connection with our continuing operations. Commitments and Contingencies Contractual Obligations As of June 30, 2026, we had outstanding total non-cancelable purchase obligations of $5.7 million for manufacture and supply of roxadustat and $1.0 million for general purchases, all of which are expected to be paid within the next 12 months. We expect to fulfill our commitments under these agreements in the normal course of business, and as such, no liability has been recorded. Under the RIFA with NovaQuest, as of June 30, 2026, we had $70.7 million of liability related to sale of future revenues in the condensed consolidated balance sheets, $0.2 million of which we anticipate to pay within the next 12 month. Based on our current estimates of drug product revenue and revenue from milestone payments under the Astellas Agreements, and taking into the consideration of the terms under the RIFA, we anticipate to reach a payment cap up to $125.0 million by 2031. See Note 8, Liability Related to Sale of Future Revenues, to the condensed consolidated financial statements for details. 37 Table of Contents CRITICAL ACCOUNTING POLICIES AND ESTIMATES Our management’s discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared in accordance with accounting principles generally accepted in the U.S. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, and expenses and the disclosure of contingent assets and liabilities in our financial statements. We evaluate our estimates and judgments on an ongoing basis. We base our estimates on historical experience, known trends and events, and various other factors that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. There have been no material changes in our critical accounting policies, estimates and judgments during the three and six months ended June 30, 2026 compared with the disclosures in Part II, Item 7 of our 2025 Form 10-K. ITEM 3. QUANTITATIVE AND QUALITAT IVE DISCLOSURES ABOUT MARKET RISK. We are a smaller reporting company as defined in Rule 12b-2 of the Exchange Act; therefore, pursuant to Item 305(e) of Regulation S-K, we are not required to provide the information required by this Item.