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Item 2. Management’s Discussion and Analysis

2026-05-12 compared with 2025-11-10 · 191 added, 237 removed, 229 unchanged (65% of the section changed)

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BUSINESS OVERVIEW

FibroGen, Inc.

(“FibroGen” or the “Company”) is a biopharmaceutical company focused on development of novel therapies at the frontiers of cancer biology and anemia.

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 analysis 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 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.

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.

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 by the Company and AstraZeneca Treasury Limited on February 20, 2025, as amended (“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.

(“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.

For additional details, refer to Note 2, Discontinued Operations and Divestiture, to the condensed consolidated financial statements.

FibroGen 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.

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.

(“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”).

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one for Japan, and one for Europe, the Commonwealth of Independent States, the Middle East and South Africa.

We continue to work on our development plan for roxadustat in anemia associated with lower-risk myelodysplastic syndromes (“MDS”), a high-value indication with significant unmet medical need.

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 had a positive Type-C meeting with the U.S.

Food and Drug Administration (“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 inclusion criteria.

We are starting preparations for the Phase 3 trial, while evaluating internal development and potential partnership opportunities for this late-stage program.

We plan to submit the Phase 3 trial protocol to the FDA in the fourth quarter of 2025.

We are now finalizing 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.

The FDA granted roxadustat Orphan Drug Designation for the treatment of MDS in December 2025.

Financial Highlights

Three Months Ended September 30,

Nine Months Ended September 30,

Three Months Ended March 31,

(in thousands, except for per share data)

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Loss from continuing operations per share - basic and diluted

September 30, 2025

March 31, 2026

December 31, 2025

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Cash and cash equivalents

Short-term investments

Accounts receivable

Long-term investments

Our revenue for the three and nine months ended September 30, 2025 included primarily the drug product revenue of $1.0 million and $4.8 million, respectively, related to active pharmaceutical ingredient (“API”) deliveries to Astellas.

As a comparison, our revenue for the three and nine months ended September 30, 2024 included primarily the revenue recognized related to the following, respectively:

• A net reduction of $0.3 million and $0.7 million to drug product revenue related to API deliveries to Astellas;

in addition, $25.7 million cumulative catch-up net adjustment in the drug product revenue, for the nine months ended September 30, 2024, as a result of terminating the AstraZeneca U.S./RoW Agreement (as defined below), effective in February 2024 (“AstraZeneca Termination and Transition Agreement”), with the exception of South Korea;

• $0.4 million and $1.5 million of development and other revenue recognized mainly under our collaboration agreements with our partners Astellas and AstraZeneca.

Operating costs and expenses for the three and nine months ended September 30, 2025 decreased compared to the same periods a year ago primarily as a result of the net effect of the following, respectively:

• $18.6 million restructuring charge recorded in the third quarter of 2024 related to the reduction in force plan in August 2024, which did not recur in the current year period;

• $7.7 million and $22.9 million lower facilities-related expenses due to cost control efforts including the lease termination in the third quarter of 2024;

• $5.9 million and $18.6 million lower stock-based compensation primarily resulting from significantly lower stock price and cancellations of stock options and restricted stock units due to reduced headcount and terminations;

• $4.4 million and $14.9 million lower clinical trial expenses primarily associated with the termination of pamrevlumab programs during the second half of 2024 responding to the topline clinical data results we reported in July 2024;

• $1.7 million and $6.8 million lower drug development expenses associated with drug substance activities and logistic expenses related to pamrevlumab programs which were completed and terminated;

• $0.8 million and $25.0 million lower employee-related expenses primarily due to the impact from reduction in force action in August 2024 and cost control efforts;

• $21.1 million one-time cost of goods sold recorded for the nine months ended September 30, 2024 correspondingly to the above-mentioned drug product revenue resulting from the AstraZeneca Termination and Transition Agreement related to the AstraZeneca U.S./RoW Agreement, as defined further below.

For the three months ended September 30, 2025, we had a loss from continuing operations of $13.1 million, or a loss per basic and diluted share of $3.25, as compared to a loss of $48.3 million, or a loss per basic and diluted share of $12.01, for the same period a year ago, due to decreases in operating costs and expenses as discussed above.

For the nine months ended September 30, 2025, we had a loss from continuing operations of $43.6 million, or a loss per basic and diluted share of $10.79, as compared to a loss of $144.4 million, or a loss per basic and diluted share of $36.19, for the same period a year ago, due to decreases in operating costs and expenses offset by decreases in revenue as discussed above.

Cash and cash equivalents, investments and accounts receivable totaled $121.1 million at September 30, 2025, an increase of $70.2 million from December 31, 2024.

Upon the the close of our sale of FibroGen International to AstraZeneca Treasury Limited during the third quarter of 2025, we accessed the entirety of our cash and cash equivalents held in China.

Consolidated cash and cash equivalents and accounts receivable for both continuing operations and discontinued operations totaled $121.1 million at December 31, 2024.

For additional details, refer to Note 2, Discontinued Operations and Divestiture, to the condensed consolidated financial statement, and the Liquidity and Capital Resources section below.

Our revenue for the three months ended March 31, 2026 and 2025 primarily included $3.5 million and $2.6 million, respectively, of drug product revenue from commercial-grade active pharmaceutical ingredient (“API”) or bulk drug product sales to Astellas.

Operating costs and expenses for the three months ended March 31, 2026 remained relatively flat compared to the same period a year ago primarily as a result of the net effect of the following, respectively:

• $1.4 million lower employee-related expenses primarily due to reduced headcount;

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

• $1.3 million lower stock-based compensation primarily resulting from lower stock price and reduced headcount;

• $3.9 million higher cost of goods sold recorded during the three months ended March 31, 2026 corresponding to the drug product revenue.

For the three months ended March 31, 2026, we had a loss from continuing operations of $15.1 million, or a loss per basic and diluted share of $3.74, as compared to a loss of $16.8 million, or a loss per basic and diluted share of $4.15, for the same period a year ago, primarily due to the increase in revenue as discussed above.

Cash and cash equivalents, investments and accounts receivable totaled $100.3 million at March 31, 2026, a decrease of $9.1 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 Metastatic Castration Resistant Prostate Cancer

FG-3246 and FG-3180 in mCRPC

Disease Overview

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Approximately 13% of men will be diagnosed with prostate cancer at some point during their lifetime.

There are about 65,000 drug treatable mCRPC cases in the U.S.

annually and 5-year survival in mCRPC is approximately 30%.

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.

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 previously treated with an ARSI/ARPI for metastatic hormone-sensitive prostate cancer will then receive chemotherapy in first-line mCRPC.

Rechallenge with an alternative ARSI/ARPI is associated with limited benefit in this setting.

For the 25-30% of patients with homologous recombination repair mutation, poly (ADP-ribose) polymerase inhibitors are the standard of care for mCRPC patients.

Recent approvals of prostate-specific membrane antigen (“PSMA”)-targeted radiopharmaceuticals in the post-ARPI and post-chemotherapy setting have diversified treatment options in advanced mCRPC.

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 (lutetium Lu 177 vipivotide tetraxetan).

FibroGen 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 approximately 5.6-6 months after switching to a different ARPI, and approximately 8 months with chemotherapy.

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.

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.

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Phase 2 Monotherapy Clinical Trial of FG-3246 and FG-3180 for the Treatment of mCRPC

We are developing FG-3246 in mCRPC and exploring other potential cancer indications.

FG-3246 is a potential first-in-class ADC targeting a novel epitope on CD46.

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 initiated a Phase 2 monotherapy, dose-optimization study of FG-3246 for the treatment of mCRPC in the third quarter of 2025, with interim results expected in the second half of 2026.

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 .

The 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.

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.

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Secondary endpoints include radiographic progression-free survival (“rPFS”), prostate-specific antigen (“PSA”) 50 response, and PSA90 response.

An interim analysis is planned once 12 patients enrolled in each of the three dose arms have completed 12 weeks on study or discontinued and is anticipated in the second half of 2026.

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 will evaluate FG-3180, a companion PET imaging agent, as a diagnostic radiopharmaceutical.

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Prior Studies of FG-3246 and FG-3180 for the Treatment of mCRPC

In March 2025, FibroGen 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 Oncology.

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 mCRP.

(“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:

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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 May 2024, the University of California, San Francisco (“UCSF”) presented positive interim results from the dose escalation portion of the investigator-sponsored Phase 1b/2 study of FG-3246 in combination with enzalutamide in patients with mCRPC at the 2024 American Society of Clinical Oncology Annual Meeting.

The presentation includes data from 17 biomarker unselected patients in the dose escalation portion of the trial.

Over 70% of the patients in the study received at least two prior ARPIs, which included prior enzalutamide treatment.

Dose escalation was explored with and without prophylactic granulocyte colony-stimulating factor (“G-CSF”) support.

The primary endpoint was determination of the maximally tolerated dose of FG-3246 in combination with enzalutamide.

The combination treatment demonstrated an encouraging preliminary estimate of median radiographic progression-free survival (“rPFS”) of 10.2 months.

The maximally tolerated dose was established at 2.1 mg/kg adjusted body weight, with primary G-CSF prophylaxis, in combination with enzalutamide 160 mg/day.

The most frequent adverse events were consistent with other MMAE-based ADCs and included fatigue, weight loss, elevated transaminases, neutropenia, and peripheral neuropathy.

We expect topline results from the Phase 2 portion of this study in the first quarter of 2026.

ROXADUSTAT IN ANEMIA ASSOCIATED WITH MYELODYSPLASTIC SYNDROMES

FibroGen maintains its rights to roxadustat in the U.S.

and in all markets not licensed to Astellas.

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 inclusion criteria.

We are starting preparations for the Phase 3 trial, while evaluating internal development and potential partnership opportunities for this late-stage program.

We plan to submit the Phase 3 trial protocol to the FDA in the fourth quarter of 2025.

The planned Phase 3 trial will 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 the patient population (patients requiring ≥ 4 pRBC units in two consecutive 8-week periods prior to randomization, who are refractory to, intolerant to, or ineligible for prior erythropoiesis-stimulating agents (ESA) therapy), dose regimen, as well as management of potential thrombotic risk through eligibility and dose modification and discontinuation criteria.

As the primary endpoint for the study, the Company is considering either 8-week or 16-week RBC TI.

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 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.

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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 Myelodysplastic Syndromes

Stem cell transplant 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 transfusions as the mainstay of care in MDS patients.

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 red blood cell 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.

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 and they 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 MDS.

Market Opportunity for Roxadustat in Myelodysplastic Syndromes

We believe there is a significant need for a safe, effective, and convenient option to address anemia in patients with lower-risk MDS.

Roxadustat, our orally administered small molecule hypoxia-inducible prolyl hydroxylase (“HIF-PH”) inhibitor, stimulates the body’s natural mechanism of red blood cell 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 red blood cell 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 MDS patients.

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.

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 MDS anemia patients, where it is not uncommon for patients to present with autoimmune and inflammatory conditions.

Phase 2/3 Clinical Trial in Myelodysplastic Syndromes

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 are advancing preparations for the Phase 3 trial, while evaluating internal development and potential partnership opportunities for this late-stage program.

We are now finalizing 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.

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 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 agents (ESA) therapy), dose regimen.

For the primary endpoint of RBC transfusion independence, we are considering independence over either an 8-week period or 16-week period.

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.

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however, the p-value was not significant.

However, in a 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, versus 7% of the 15 placebo patients (nominal p-value of 0.04).

Roxadustat in Anemia of Chronic Kidney Disease

In a 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, versus 7% of the 15 placebo patients (nominal p-value of 0.04).

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 (Hong Kong) Ltd.

(“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 (China) Medical Technology Development Co., Ltd (“FibroGen Beijing”) and its 51.1% interest in Beijing Falikang Pharmaceutical Co., Ltd.

(“Falikang”).

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 2, Discontinued Operations and Divestiture, to the condensed consolidated financial statements .

U.S., Europe, Japan and Rest of World - Roxadustat Program

FibroGen has retained the rights to roxadustat in the U.S., Canada, Mexico, and in all markets not held by AstraZeneca or licensed to Astellas.

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 from and Option to Acquire Fortis Therapeutics

In May 2023, we entered into an exclusive option agreement to acquire Fortis with its novel Phase 1 ADC, FG-3246 (previously FOR46), that targets a novel epitope on CD46 preferentially expressed on certain cancer cells.

Exclusive License and Option to Acquire Fortis Therapeutics

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, FibroGen has exclusively licensed FG-3246 and will control and fund future research, development, including a Phase 2 clinical study sponsored by FibroGen, and manufacturing of FG-3246 during the option period.

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.

FibroGen have made four quarterly payments totaling $5.4 million to Fortis in support of its continued development obligations, of which the last payment was $1.7 million and was made during the three months ended March 31, 2024.

If we exercise the option to acquire Fortis, we will pay Fortis $80.0 million, and thereafter, Fortis would be eligible to receive from FibroGen up to $200.0 million in contingent payments associated with the achievement of various regulatory approvals.

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 FibroGen chooses not to acquire Fortis, its exclusive license to FG-3246 would expire.

On March 28, 2025, the Company and Fortis entered into amendments and modified the option exercise deadline to December 31, 2027.

If Kyntra Bio chooses not to acquire Fortis, its exclusive license to FG-3246 would expire.

For additional details about this transaction, see the Consolidated Variable Interest Entity - Fortis section in Note 4, Variable Interest Entities , to the condensed consolidated financial statements.

Exclusive License to Eluminex

In April 2023, FibroGen and Eluminex entered into an Amended and Restated Exclusive License Agreement (“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).

On August 5, 2025, FibroGen accepted the assignment and delegation from FibroGen Hong Kong, FibroGen Beijing, and Falikang of their respective rights and obligations under the A&R Eluminex Agreement.

In April 2023, we 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).

Collaboration Partnerships for Roxadustat

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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 a separate collaboration 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 September 30, 2025 totaled $790.1 million.

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 March 31, 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 $(0.4) million and $(1.4) million for the three months ended September 30, 2025 and 2024, and $1.4 million and $(3.9) million for the nine months ended September 30, 2025 and 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 FibroGen in support of commercial supplies (the “Astellas EU Supply Agreement”).

The related drug product revenue was $1.3 million and $1.1 million for the three months ended September 30, 2025 and 2024, and $3.3 million and $3.2 million for the nine months ended September 30, 2025 and 2024, respectively.

The related drug product revenue was ($2.2) million and $1.8 million for the three months ended March 31, 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 million and $0.8 million for the three months ended March 31, 2026 and 2025, 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 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 FibroGen in support of commercial supplies.

On February 25, 2024, we entered into an agreement to terminate the AstraZeneca U.S./RoW Agreement with AstraZeneca, as amended and restated 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’s sales of roxadustat in the terminated territories, or thirty-five percent of all revenue FibroGen receives if it licenses or sells such rights to a third-party.

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 addition, resulting from the AstraZeneca Termination and Transition Agreement, FibroGen 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.

AstraZeneca was our long-time commercialization partner for roxadustat in greater China.

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”).

Under the AstraZeneca agreements, the aggregate amount of consideration received through September 30, 2025 totaled $81.2 million.

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 2, Discontinued Operations and Divestiture, to the condensed consolidated financial statements.

AstraZeneca China Amendment

In July 2020, FibroGen China and AstraZeneca entered into an amendment, effective July 1, 2020, to the AstraZeneca China Agreement, relating to the development and commercialization of roxadustat in China (the “AstraZeneca China Amendment”).

Under the AstraZeneca China Amendment, 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 account for our investment in Falikang under the equity method, and Falikang is not consolidated into our consolidated financial statements.

Our proportionate share of the reported profits or losses of Falikang, is included in the discontinued operations in the condensed consolidated statement of operations, and the investment in unconsolidated subsidiary is included the held for sale assets on the condensed consolidated balance sheet.

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 2, Discontinued Operations and Divestiture , to the condensed 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 are made by Falikang, while FibroGen Beijing continues to sell roxadustat product directly in limited areas in China.

FibroGen Beijing manufactures and supplies commercial product to Falikang based on an agreed upon transfer price, which includes gross transaction price, net of calculated profit share.

We recognize revenue upon the transfer of control of commercial products to Falikang in an amount that reflects the allocation of transaction price of the China manufacturing and supply obligation (“China performance obligation”) to the performance obligation satisfied during the reporting period.

For our direct sales of commercial drug product, we recognize revenue when control of the promised good is transferred to the customer in an amount that reflects the consideration that we expect to be entitled to in exchange for the product.

Product revenue, net, was $39.8 million for the three months ended March 31, 2025, majority of which were from the sales to Falikang, and was included in the discontinued operations.

As discussed in Note 2, 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.

As a result, all the previously deferred revenues were recognized as revenue during the three months ended September 30, 2025.

We recognized net product revenue of $167.2 million and $46.2 million for the three months ended September 30, 2025 and 2024, and $226.7 million and $126.4 million for the nine months ended September 30, 2025 and 2024, respectively, majority of which were from the sales to Falikang.

RESULTS OF OPERATIONS

Three Months Ended September 30,

Nine Months Ended September 30,

Three Months Ended March 31,

(dollars in thousands)

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We recognize development services as revenue in the period in which they are billed to our partners, excluding China.

As of September 30, 2025, we do not expect to incur significant future co-development services.

As of March 31, 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 AstraZeneca, under the AstraZeneca U.S./RoW Agreement, and Astellas in support of pre-commercial preparation prior to the new drug application or marketing authorization application approval, and to Astellas for ongoing commercial launch in Japan and Europe.

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.

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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.

The AstraZeneca U.S./RoW Agreement was terminated on February 25, 2024 (except for South Korea).

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 2, Discontinued Operations and Divestiture, to the condensed 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.

Total revenue increased $1.0 million, or 775%, for the three months ended September 30, 2025, and decreased $21.3 million, or 81%, for the nine months ended September 30, 2025, respectively, compared to the same periods a year ago for the reasons discussed in the sections below.

Total revenue increased $1.0 million, or 36%, for the three months ended March 31, 2026, compared to the same period a year ago for the reasons discussed in the sections below.

Drug Product Revenue, Net

Three Months Ended September 30,

Nine Months Ended September 30,

Three Months Ended March 31,

(dollars in thousands)

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Astellas Europe Agreement

AstraZeneca U.S./RoW Agreement

Total drug product revenue, net:

NM = Not meaningful

Drug product revenue, net increased $1.2 million, or 465%, for the three months ended September 30, 2025, and decreased $20.2 million, or 81%, for the nine months ended September 30, 2025, respectively, compared to the same periods a year ago.

Drug product revenue, net increased $0.9 million, or 35%, for the three months ended March 31, 2026, compared to the same period a year ago.

Astellas Japan Agreement

During the third 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 a reduction to the drug product revenue of $0.4 million.

Specifically, the change in estimated variable consideration was based on the API held by Astellas at period end, adjusted to reflect 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 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.

During the third quarter of 2024, 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 $1.4 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 bulk product strength mix intended to be manufactured by Astellas, among others.

During the second quarter of 2024, 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 $0.4 million.

Specifically, the change in estimated variable consideration was based on the API held by Astellas at period end, adjusted to reflect the foreign exchange impacts and the changes in the estimated bulk product strength mix intended to be manufactured by Astellas, among others.

During the first quarter of 2024, 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.

As of September 30, 2025, the balances related to the API price true-up under the Astellas Japan Agreement were $1.0 million in accrued liabilities, representing our best estimate of the timing for these amounts to be paid.

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

Astellas Europe Agreement

We updated our estimate of variable consideration related to the bulk drug product transferred under the terms of the Astellas Europe Agreement and the Astellas EU Supply Agreement in prior years.

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.

In addition, 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, for the year ended December 31, 2024, we reclassified $7.2 million from the related deferred revenue to accrued liabilities.

As of December 31, 2024, the related balance in accrued liabilities was $10.5 million.

We further reclassified $0.9 million from the related deferred revenue to accrued liabilities during the nine months ended September 30, 2025.

As of September 30, 2025, the balances related to the bulk drug product price true-up under the Astellas Europe Agreement and the Astellas EU Supply Agreement were $11.4 million in accrued liabilities, representing our best estimate that these amounts will be paid within the next 12 month, a $7.1 million of which was paid to Astellas in October 2025.

We recognized royalty revenue as drug product revenue, from the deferred revenue under the Astellas Europe Agreement, of $1.3 million and $1.1 million for the three months ended September 30, 2025 and 2024, and $3.3 million and $3.2 million for the nine months ended September 30, 2025 and 2024, respectively.

As a result, for the three months ended March 31, 2026, we reclassified $0.5 million from the related deferred revenue to accrued liabilities.

As of March 31, 2026, the balances related to the bulk drug product price true-up under the Astellas Europe Agreement and the Astellas EU Supply Agreement were $1.9 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.

We recognized royalty revenue as drug product revenue, from the deferred revenue under the Astellas Europe Agreement, of $1.5 million and $0.8 million for the three months ended March 31, 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.

AstraZeneca U.S./RoW Agreement

As described above, pursuant to the AstraZeneca Termination and Transition Agreement related to the AstraZeneca U.S./RoW Agreement, FibroGen 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 agreement 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.

Operating Costs and Expenses

Three Months Ended September 30,

Nine Months Ended September 30,

Three Months Ended March 31,

(dollars in thousands)

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Total operating costs and expenses

Total operating costs and expenses decreased $41.3 million, or 86%, and decreased $132.2 million, or 78%, for the nine months ended September 30, 2025, respectively, compared to the same periods a year ago for the reasons discussed in the sections below.

Total operating costs and expenses decreased $0.1 million, or 1%, for the three months ended March 31, 2026, compared to the same period a year ago for the reasons discussed in the sections below.

Cost of Goods Sold

Cost of goods sold was immaterial for the three months ended September 30, 2025 and 2024.

Cost of goods sold decreased $21.1 million, or 99%, for the nine months ended September 30, 2025, compared to the same period a year ago.

As described above, during the first quarter of 2024, we recorded a cumulative catch-up net adjustment to the drug product revenue resulting from the AstraZeneca Termination and Transition Agreement related to the AstraZeneca U.S./RoW Agreement.

Correspondingly, we recorded the related cost of goods sold of $21.1 million in the same period.

Cost of goods sold increased $3.9 million, or 1,529%, for the three months ended March 31, 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 three months ended March 31, 2026.

Research and Development Expenses

Research and development expenses consist of third-party research and development costs and the fully-burdened amount of costs associated with work performed under collaboration agreements.

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.

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in the third quarter of 2024.

As a result, research and development expenses have overall decreased.

The following table summarizes our research and development expenses incurred during the three and nine months ended September 30, 2025 and 2024:

Three Months Ended September 30,

Nine Months Ended September 30,

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 months ended March 31, 2026 and 2025:

Three Months Ended March 31,

Product Candidate

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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 decreased $18.8 million, or 94%, for the three months ended September 30, 2025, and decreased $72.6 million, or 82%, for the nine months ended September 30, 2025, respectively, compared to the same periods a year ago, primarily as a result of the net effect of the following:

• Decrease of $7.2 million and $19.1 million in facilities-related expenses due to cost control efforts including the lease termination in the third quarter of 2024;

• Decrease of $4.4 million and $14.9 million in clinical trials costs primarily associated with the termination of pamrevlumab programs during the second half of 2024 responding to the topline clinical data results we reported in July 2024;

• Decrease of $4.1 million and $11.0 million in stock-based compensation primarily resulting from significantly lower stock price and cancellations of stock options and restricted stock units due to reduced headcount and terminations;

• Decrease of $1.7 million and $6.8 million in drug development expenses associated with drug substance activities and logistic expenses related to pamrevlumab programs which were completed and terminated;

• Decrease of $1.0 million and $17.2 million in employee-related costs primarily due to the impact from reduction in force action in August 2024 and cost control efforts.

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

• Decrease of $1.1 million employee-related costs primarily due to lower headcount;

• Decrease of $0.7 million in stock-based compensation primarily resulting from lower stock price and reduced headcount;

• Increase of $1.1 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 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 facility-related costs, professional fees, accounting and legal services, other outside services, recruiting fees and expenses associated with obtaining and maintaining patents.

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.

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As a result, SG&A expenses have overall decreased and may continue to decrease over time.

SG&A expenses decreased $4.1 million, or 43%, for the three months ended September 30, 2025, and decreased $20.5 million, or 50%, for the nine months ended September 30, 2025, respectively, compared to the same periods a year ago, primarily as a result of the net effect of the following, respectively:

• Decrease of $1.8 million and $7.6 million in stock-based compensation primarily resulting from significantly lower stock price and cancellations of stock options and restricted stock units due to reduced headcount;

• Decrease of $7.8 million in employee-related costs for the nine month period, primarily due to the impact from reduction in force action in August 2024 and cost control efforts;

• Decrease of $3.8 million in facilities-related expenses for the nine month period, due to cost control efforts including the lease termination in the third quarter of 2024.

Restructuring Charge

In response to the topline clinical results for pamrevlumab in patients with pancreatic cancer we announced in July 2024, we implemented an immediate and significant cost reduction plan in the U.S., including terminating pamrevlumab research and development investment and expeditiously winding down remaining obligations, and reducing our U.S.

workforce by approximately 75%.

As a result, we recorded majority of the related non-recurring restructuring charge of $18.6 million during the third quarter of 2024, primarily consisting of notice period and severance payments, accrued vacation, and employee benefits contributions.

The related restructuring charges for the three and nine months ended September 30, 2025 were not material.

SG&A expenses decreased $2.2 million, or 28%, for the three months ended March 31, 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 million in equipment and facilities-related expenses due to cost control efforts;

• Decrease of $0.6 million in stock-based compensation primarily resulting from lower stock price and reduced headcount.

Interest and Other, Net

Three Months Ended September 30,

Nine Months Ended September 30,

Three Months Ended March 31,

(dollars in thousands)

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Interest expense

Loss on debt extinguishments

Interest income and other income (expenses), net

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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 nine months ended September 30, 2025, compared to the same periods a year ago.

Loss on debt extinguishments

On August 29, 2025, upon the above-mentioned completion of the sale of our China operations through FibroGen International to AstraZeneca Treasury Limited, we paid a total of $80.9 million to Morgan Stanley Tactical Value (“MSTV”), including $75.0 million for paying off the senior secured term loan facilities, $0.4 million for outstanding interest and $5.5 million for related premium and fees.

Accordingly, we recorded a loss on debt extinguishments of $6.6 million for the three and nine months ended September 30, 2025.

See Note 7, Senior Secured Term Loan Facilities , to the condensed consolidated financial statements for details.

Interest expense remained relatively flat for the three months ended March 31, 2026, compared to the same period a year ago.

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 decreased $0.5 million, or 37%, and decreased $3.0 million, or 65%, for the nine months ended September 30, 2025, respectively, compared to the same periods a year ago, primarily due to lower interest income resulting from overall lower cash equivalents and investment balances during the current year periods.

Three Months Ended September 30,

Nine Months Ended September 30,

Interest income and other income (expenses), net increased $0.7 million, or 169%, for the three months ended March 31, 2026, compared to the same period a year ago, primarily due to higher interest income resulting from overall higher cash equivalents and investment balances during the current year periods.

Three Months Ended March 31,

(dollars in thousands)

Loss from continuing operations before income taxes

Provision for (benefit from) income taxes

Provision for income taxes

Effective tax rate

Provision for (benefits from) income taxes for the three and nine months ended September 30, 2025 and 2024 were primarily related to foreign taxes.

Provision for income taxes for the three months ended March 31, 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.

We intend to continue maintaining a full valuation allowance on our deferred tax assets until there is sufficient evidence to support the reversal of all or some portion of this allowance.

Discontinued Operations

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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 sales 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:

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.

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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.

The clinical development milestones which could have triggered Delayed Draw Term Loan 1 were not achieved, and the Lenders have not funded Delayed Draw Term Loan 2.

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 NovaQuest Capital Management (“NovaQuest”) with respect to our revenues from Astellas’ sales of roxadustat in Europe, Japan and the other Astellas territories.

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.

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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 during the three and nine months ended September 30, 2025.

Cash and cash equivalents, investments and accounts receivable totaled $121.1 million at September 30, 2025.

Upon the close of our sale of FibroGen International to AstraZeneca during the third quarter of 2025, we accessed the entirety of our cash and cash equivalents held in China.

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 intends to timely submit 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 $100.3 million at March 31, 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.

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:

Nine Months Ended September 30,

Three Months Ended March 31,

Net cash provided by (used in):

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Effect of exchange rate changes on cash and cash equivalents

Net increase in cash and cash equivalents

Net increase (decrease) in cash and cash equivalents

Operating Activities

Net cash provided by operating activities was $13.6 million for the nine months ended September 30, 2025 and consisted primarily of net income of $197.7 million adjusted for non-operating cash items of $35.9 million, and a net decrease in operating assets and liabilities of $148.2 million.

The significant non-operating cash items included gain on divesture of FibroGen International of $52.2 million, loss on debt extinguishments of $6.6 million and stock-based compensation expense of $5.4 million.

Net cash used in operating activities was $13.9 million for the three months ended March 31, 2026 and consisted primarily of net loss of $15.2 million adjusted for non-operating cash items of $1.0 million, and a net increase in operating assets and liabilities of $0.3 million.

The significant non-operating cash items included stock-based compensation expense of $1.2 million.

The significant items in the changes in operating assets and liabilities included the following:

• Deferred revenue decreased $136.3 million, due to the recognition of all the previously deferred balance related to our China performance obligation under our agreements with AstraZeneca during the three months ended September 30, 2025 upon the completion of the divestiture of FibroGen International on August 29, 2025, as the performance obligation to AstraZeneca were completely satisfied upon the closing of the divestiture.

See the China Performance Obligation section in Note 3, Collaboration Agreements, License Agreement and Revenues , to the condensed consolidated financial statements for details;

• Accrued and other liabilities decreased $48.1 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, $7.8 million of the transaction costs related to the divestiture, and the $3.2 million payments of accrued restructuring charge.

The accrued and other liabilities were also impacted by cost control efforts and the timing of invoicing and payment;

• Accounts payable decreased $26.3 million, primarily driven by the payments made during the current year period to AstraZeneca under the settlement agreements entered in September 2024 between FibroGen China and AstraZeneca to settle certain historical items;

• Prepaid expenses and other current assets decreased $54.8 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 current year period based on the arrangements under the above-mentioned settlement agreements between FibroGen China and AstraZeneca to settle certain historical items, which was unbilled receivables as of December 31, 2024;

• Accrued interest expense related to sale of future revenues increased $5.7 million due to the interest expense of $6.1 million accrued, offset by the interest paid of $0.5 million during the period.

• Deferred revenue increased $4.2 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 first quarter of 2026;

partially offset by $1.5 million royalty revenue recognized, and $0.5 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 3, Collaboration Agreements, License Agreement and Revenues , to the condensed consolidated financial statements for details;

• Accounts payable increased $1.3 million driven by timing of invoicing and payments.

• Accrued interest expense related to sale of future revenues increased $1.0 million due to the interest expense of $2.3 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.

• Inventory decreased $5.2 million primarily driven by lower inventory production in China as we have decommissioned our API manufacturing facility in Cangzhou, China in late 2024.

Inventory in China was part of the held-for-sale assets as of December 31, 2024 as discussed in Note 2, Discontinued Operations and Divestiture, to the condensed consolidated financial statements.

Net cash used in operating activities was $107.5 million for the nine months ended September 30, 2024 and consisted primarily of net loss of $65.6 million adjusted for non-operating cash items of $27.7 million, and a net decrease in operating assets and liabilities of $69.7 million.

• Accounts receivable increased $4.8 million driven by the billing to Astellas for the bulk drug product transferred during the first quarter of 2026;

• Accrued and other liabilities decreased $2.5 million, driven by the bonus payment during the quarter.

Net cash provided by operating activities was $2.7 million for the three months ended March 31, 2025 and consisted primarily of net income of $4.6 million adjusted for non-operating cash items of $3.7 million, and a net decrease in operating assets and liabilities of $5.7 million.

The significant non-operating cash items included stock-based compensation expense of $2.9 million.

The significant items in the changes in operating assets and liabilities included the following:

• Operating lease right-of-use assets decreased $66.0 million, operating lease liabilities, non-current decreased $65.8 million and operating lease liabilities, current decreased $12.8 million related to the operating lease termination of our corporate headquarters;

• Prepaid expenses and other current assets increased $18.2 million, primarily due to the $24.8 million of unbilled receivables from Falikang based on the arrangements under the settlement agreements entered in September 2024 between FibroGen China and AstraZeneca to settle certain historical items, and the reimbursements from the insurance for the legal fees associated with the class action lawsuit, which is recoverable under our insurance policies;

• Accrued and other liabilities decreased $17.1 million, primarily driven by payment of $35.3 million to Astellas and $11.5 million to AstraZeneca related to accrued API and bulk drug product price true-up and bonus and severance payouts, totaling $25.2 million.

The decreases were offset by $42.4 million of historical co-promotion balances due to AstraZeneca based on the arrangements under the above-mentioned settlement agreements, accrued restructuring charge of $18.6 million related to the reduction in force in August 2024, and accrued inventory related cost of $8.5 million as of September 30, 2024, as part of the cost of goods sold resulting from the above-mentioned termination of the AstraZeneca U.S./RoW agreement.

• Accrued and other liabilities decreased $31.7 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, and bonus and severance payouts totaling $5.1 million during the quarter.

The accrued and other liabilities were also impacted by cost control efforts and the timing of invoicing and payment;

• Accounts receivable increased $16.0 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, as well as the timing of receipt of the billings under our collaboration and license agreements;

• Deferred revenue decreased $15.2 million, primarily related to the $33.1 million product revenue recognized from the previously deferred revenue of the China performance obligation during the nine months ended September 30, 2023.

In addition, the decrease in deferred revenue was also related to the $3.2 million royalty revenue recognized from the deferred revenue under the Astellas Europe Agreement, and the reclassification of $5.6 million to accrued liabilities, resulting from changes in estimated variable consideration 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 nine months ended September 30, 2023.

Deferred revenue was no longer netted against any contract assets as of September 30, 2024, and the $22.5 million of unbilled co-development revenue under the AstraZeneca China Amendment and the $4.0 million unbilled regulatory milestone payment under the AstraZeneca China Agreement as of December 31, 2023 were billed during the three months ended September 30, 2024 under the above-mentioned settlement agreements;

• Accounts payable decreased $8.7 million, primarily driven by the timing of invoicing and payments and cost control efforts;

• Inventory decreased $17.8 million primarily driven by the $12.6 million of work-in-progress inventory that was reimbursed as part of the above-mentioned termination of the AstraZeneca U.S./RoW agreement.

• Accounts payable decreased $24.8 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;

• Deferred revenue decreased $4.1 million, primarily related to the reclassification of $2.1 million to accrued liabilities, resulting from changes in estimated variable consideration 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 year.

In addition, the decrease in deferred revenue was also related to the $1.3 million product revenue recognized, which is included in the discontinued operations, from the previously deferred revenue of the China performance obligation during the quarter;

• Accounts receivable increased $3.2 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;

• Prepaid expenses and other current assets decreased $52.6 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;

• Inventory decreased $2.9 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 $1.7 million due to the interest expense of $2.2 million accrued, offset by the interest paid, during the quarter.

Investing Activities

Investing activities primarily consist of net proceeds from divestiture, purchases of investments and proceeds from the maturity and sale of investments.

Net cash provided by investing activities was $87.1 million for the nine months ended September 30, 2025 and consisted primarily of $90.2 million net proceeds from the divestiture of FibroGen International on August 29, 2025, which included the $210.4 million of cash received at closing, net of the $120.2 million cash in China at the closing that were derecognized upon the divestiture;

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 $3.0 million for the three months ended March 31, 2026 and consisted primarily of $14.1 million proceeds from maturity of investments;

partially offset by $11.1 million cash used in purchases of available-for-sale securities.

Net cash provided by investing activities was $124.3 million for the nine months ended September 30, 2024 and consisted primarily of $132.2 million of proceeds from maturities of investments, partially offset by $8.6 million of cash used in purchases of available-for-sale securities.

Net cash used in investing activities was immaterial for the three months ended March 31, 2025.

Financing Activities

Financing activities primarily reflect proceeds from strategic financing arrangements, proceeds from the issuance of our common stock, cash paid related to our senior secured term loan facilities, cash paid to shareholders and cash paid for payroll taxes on restricted stock unit releases.

Net cash used in financing activities was $86.0 million for the nine months ended September 30, 2025 and consisted primarily of $75.0 million of cash used to pay off our senior secured term loan facilities with MSTV and $5.5 million of cash paid for the related premium and fees associated with the early pay-off.

See Note 7, Senior Secured Term Loan Facilities , to the condensed consolidated financial statements for details.

Net cash used in financing activities also included $5.4 million of cash paid to FibroGen Cayman’s minority shareholders during the third quarter of 2025.

See Note 9, FibroGen Cayman Non-Controlling Interests, to the condensed consolidated financial statements for details.

Net cash used in financing activities was immaterial for the nine months ended September 30, 2024.

Financing activities primarily reflect proceeds from strategic financing arrangements, cash paid to shareholders and 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 three months ended March 31, 2026 and 2025, respectively.

Material Cash Requirements

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Contractual Obligations

As of September 30, 2025, we had outstanding total non-cancelable purchase obligations of $4.0 million for general purchases and other programs and $2.6 million for manufacture and supply of roxadustat, all of which are expected to be paid within the next 12 months.

As of March 31, 2026, we had outstanding total non-cancelable purchase obligations of $1.5 million for manufacture and supply of roxadustat and $1.1 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 September 30, 2025, we had $65.0 million of liability related to sale of future revenues in the condensed consolidated balance sheets, $1.6 million of which we anticipate to pay within the next 12 month.

Under the RIFA with NovaQuest, as of March 31, 2026, we had $68.3 million of liability related to sale of future revenues in the condensed consolidated balance sheets, $0.9 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.

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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 nine months ended September 30, 2025 compared with the disclosures in Part II, Item 7 of our 2024 Form 10-K.

There have been no material changes in our critical accounting policies, estimates and judgments during the three months ended March 31, 2026 compared with the disclosures in Part II, Item 7 of our 2025 Form 10-K.

QUANTITATIVE AND QUALITAT IVE DISCLOSURES ABOUT MARKET RISK.

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What changed 10-Q

Item 2. Management’s Discussion and Analysis