What changed in this filing

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Item 2. Management’s Discussion and Analysis

2026-08-13 compared with 2026-05-12 · 130 added, 92 removed, 328 unchanged (40% of the section changed)

34 unchanged sentences

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 patient 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 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.

We have finalized the Phase 3 trial protocol for roxadustat for the treatment of anemia in patients with lower-risk MDS with high transfusion burden and are continuing with preparations for the Phase 3 trial, while evaluating internal development and potential partnership opportunities for this late-stage program.

Kyntra Bio’s goal is to initiate the Phase 3 trial in the fourth quarter of 2026.

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

Financial Highlights

Three Months Ended March 31,

Three Months Ended June 30,

Six Months Ended June 30,

(in thousands, except for per share data)

1 unchanged sentence

Operating costs and expenses

Loss from continuing operations

Loss from continuing operations per share - basic and diluted

March 31, 2026

Total interest and other, net

Income (loss) from continuing operations

Income (loss) from continuing operations per share - basic and diluted

June 30, 2026

December 31, 2025

5 unchanged sentences

Long-term investments

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.

Our revenue for the three and six months ended June 30, 2026 primarily included $(1.6) million and $1.9 million, respectively, of drug product revenue from commercial-grade active pharmaceutical ingredient (“API”) or bulk drug product sales to Astellas.

As a comparison, our revenue for the three and six months ended June 30, 2025 primarily included $1.2 million and $3.8 million, respectively, of drug product revenue from commercial-grade API or bulk drug product sales to Astellas.

The revenue decreased compared to the same periods a year ago primarily due to the change in estimate of variable consideration related to the API shipments fulfilled under the terms of Astellas Japan Amendment (as defined below).

Operating costs and expenses for the three and six months ended June 30, 2026 increased compared to the same periods a year ago primarily as a result of the net effect of the following, respectively:

• $3.5 million and $4.3 million higher legal expenses primarily related to estimated indemnification costs associated with a former officer;

• $2.2 million and $2.1 million higher clinical trial expenses associated with FG-3246 Phase 2 trials;

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

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

• $0.3 million and $1.6 million lower stock-based compensation primarily resulting from lower stock price and reduced headcount;

• $3.8 million higher cost of goods sold recorded during the six months ended June 30, 2026 corresponding to drug product revenue.

In April 2026, our subsidiary, FibroGen Europe, voluntarily filed for bankruptcy with the Finnish bankruptcy court.

On April 16, 2026, the Helsinki District Court declared FibroGen Europe bankrupt and appointed an estate administrator to oversee the bankruptcy estate.

As a result, we determined that we no longer maintained a controlling financial interest in FibroGen Europe and therefore deconsolidated the subsidiary effective April 16, 2026.

Upon deconsolidation, we derecognized the subsidiary’s assets and liabilities and recognized a $30.9 million gain on deconsolidation.

See Note 2, Deconsolidation of European Subsidiary , to the condensed consolidated financial statements for details.

For the three months ended June 30, 2026, we had income from continuing operations of $12.0 million, or an earnings per basic and diluted share of $2.96, as compared to a loss of $13.7 million, or a loss per basic and diluted share of $3.38, for the same period a year ago, and for the six months ended June 30, 2026, we had a loss from continuing operations of $3.2 million, or a loss per basic and diluted share of $0.78, as compared to a loss of $30.4 million, or a loss per basic and diluted share of $7.54, for the same period a year ago, primarily due to the gain on deconsolidation of subsidiary, offset by increases in operating costs and expenses and decreases in revenue.

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

Commercial, Development and Research Programs

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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.

An exploratory sub-study is evaluating FG-3180, a companion PET imaging agent, as a diagnostic radiopharmaceutical.

All patients deemed eligible for participation in the Phase 2 trial will participate in the sub-study evaluating FG-3180 prior to randomization.

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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.

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).

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The diagnosed prevalence of MDS in the U.S.

is estimated to be between 60,000 and 170,000, and continues to rise as more therapies become available and patients are living longer with MDS.

Annual incidence rates are estimated to be 4.9/100,000 adults in the U.S.

is estimated to be approximately 74,000, and continues to rise as more therapies become available and patients are living longer with MDS.

Annual incidence rates are estimated to be 20,000 adults in the U.S., 70% of whom are considered lower-risk MDS.

Anemia is the most common clinical presentation in MDS, seen in approximately 80% of MDS patients, and produces symptoms of fatigue, weakness, exercise intolerance, shortness of breath, dizziness, and cognitive impairment.

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We had a positive Type-C meeting with the FDA in July 2025, and reached alignment on several elements of our proposed Phase 3 study design for roxadustat in anemia associated with lower-risk MDS, including the starting dose and the patient inclusion criteria.

We 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.

We have finalized the Phase 3 trial protocol for roxadustat for the treatment of anemia in patients with lower-risk MDS and high transfusion burden after receiving further comments from the FDA.

Our goal is to initiate the Phase 3 trial in the fourth quarter of 2026.

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

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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.

Alignment was reached with the FDA on key Phase 3 design elements, including the patient population (patients requiring ≥ 4 RBC units in two consecutive 8-week periods prior to randomization, who are refractory to, intolerant to, or ineligible for prior erythropoiesis-stimulating agent (ESA) therapy), dose regimen, and placebo control group with a 2:1 randomization.

We have selected 8-week transfusion independence (“TI”) (over the first 24 weeks) as the primary endpoint of the study.

The FDA recommended a longer duration of TI as the primary endpoint (16-weeks over 48 weeks), however, an 8-week primary endpoint is consistent with past and current placebo-controlled studies in this indication.

We are including 12-week, 16-week, and 24-week TI (each over 48 weeks) as key secondary endpoints.

Based on consultation with medical professionals, we believe the design of the study should provide sufficient evidence of patient benefit in this population of high-transfusion burden lower-risk MDS patients.

The study is powered to detect meaningful statistically significant differences for the primary endpoint and all key secondary endpoints.

Phase 2/3 Clinical Trial in MDS

Topline 28-week data from MATTERHORN, our Phase 2/3 placebo-controlled, double-blind clinical trial of roxadustat for the treatment of anemia in MDS, was presented in the fourth quarter of 2023 at the American Society of Hematology annual conference.

More patients in the roxadustat arm (47.5% of 80 patients) achieved transfusion independence for 56 consecutive days (within the first 28 weeks) than the placebo arm (33.3% of 57 patients);

As previously disclosed, more patients in the roxadustat arm (47.5% of 80 patients) achieved transfusion independence for 56 consecutive days (within the first 28 weeks) than the placebo arm (33.3% of 57 patients);

however, the p-value was not significant.

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).

Our European Hematology Association (EHA) Congress 2026 presentation highlighted data from a post hoc analysis of the entire trial population, demonstrating that roxadustat led to similar rates of transfusion independence in both RS+ and RS - patients.

In RS - patients, which comprised 84 of the 140 patients enrolled in the trial, treatment with roxadustat led to transfusion independence for ≥8 weeks (within the first 28 weeks) in 48% of patients vs.

28% for placebo.

In the post-hoc analysis of patients with high transfusion burden (4 or more packed RBC units over two consecutive 8-week periods), 36% of the 22 roxadustat patients achieved transfusion independence (8 weeks within the first 28 weeks), versus 7% of the 15 placebo patients (nominal p-value of 0.04).

Treatment-emergent adverse events (“TEAEs”) were generally lower grade and managed medically with no new safety signals.

Roxadustat in Anemia of CKD

8 unchanged sentences

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

Exclusive License and Option to Acquire Fortis Therapeutics

Exclusive License and Option to Acquire Fortis

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

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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, 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 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.

Under these agreements, the aggregate amount of consideration received through June 30, 2026 totaled $790.1 million.

Based on the current development plans for roxadustat in Japan and Europe, we do not expect to receive most or all of the additional potential milestones under the Astellas Japan Agreement or the Astellas Europe Agreement.

In 2018, we and Astellas entered into an amendment to the Astellas Japan Agreement that allows Astellas to manufacture roxadustat drug product for commercialization in Japan (the “Astellas Japan Amendment”).

The related drug product revenue was ($2.2) million and $1.8 million for the three months ended March 31, 2026 and 2025, respectively.

The related drug product revenue was $(2.9) million for the three months ended June 30, 2026, and immaterial for the three months ended June 30, 2025, and ($5.1) million and $1.8 million for the six months ended June 30, 2026 and 2025, respectively.

During the first quarter of 2021, we entered into an EU Supply Agreement with Astellas under the Astellas Europe Agreement to define general forecast, order, supply and payment terms for Astellas to purchase roxadustat bulk drug product from us in support of commercial supplies (the “Astellas EU Supply Agreement”).

The related drug product revenue was $5.7 million and $0.8 million for the three months ended March 31, 2026 and 2025, respectively.

The related drug product revenue was $1.4 million and $1.2 million for the three months ended June 30, 2026 and 2025, and $7.0 million and $2.0 million for the six months ended June 30, 2026 and 2025, respectively.

In July 2013, we entered into a collaboration agreement with AstraZeneca for roxadustat for the treatment of anemia in the U.S.

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See Note 3, Discontinued Operations and Divestiture , to the condensed consolidated financial statements for details.

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.

Product revenue, net, was $19.7 million and $59.5 million for the three and six months ended June 30, 2025, respectively, majority of which were from the sales to Falikang, and was included in the discontinued operations.

As discussed in Note 3, Discontinued Operations and Divestiture, to the condensed consolidated financial statements, the divestiture of FibroGen International was completed on August 29, 2025 and accordingly, the performance obligation to AstraZeneca was completely satisfied upon the closing of the divestiture.

RESULTS OF OPERATIONS

Three Months Ended March 31,

Three Months Ended June 30,

Six Months Ended June 30,

(dollars in thousands)

4 unchanged sentences

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

As of March 31, 2026, we do not expect to incur significant future co-development services.

As of June 30, 2026, we do not expect to incur significant future co-development services.

Other revenues consist of contract manufacturing revenue, patent transfer and sales of research and development material.

6 unchanged sentences

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 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.

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

Drug Product Revenue, Net

Three Months Ended March 31,

Three Months Ended June 30,

Six Months Ended June 30,

(dollars in thousands)

3 unchanged sentences

Total drug product revenue, net:

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.

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

Astellas Japan Agreement

During the second quarter of 2026, we updated our estimate of variable consideration related to the API shipments fulfilled under the terms of Astellas Japan Amendment, and accordingly recorded a reduction to the drug product revenue of $2.9 million.

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

During the first quarter of 2026, we updated our estimate of variable consideration related to the API shipments fulfilled under the terms of Astellas Japan Amendment, and accordingly recorded a reduction to the drug product revenue of $2.2 million.

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

During the second quarter of 2025, the adjustment to the drug product revenue was immaterial.

During the first quarter of 2025, we updated our estimate of variable consideration related to the API shipments fulfilled under the terms of Astellas Japan Amendment, and accordingly recorded an adjustment to the drug product revenue of $1.8 million.

Specifically, the change in estimated variable consideration was based on the API held by Astellas at period end, adjusted to reflect the changes in the estimated yield from the manufacture of bulk product tablets, among others.

As of 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.

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

Astellas Europe Agreement

We recognized royalty revenue as drug product revenue, from the deferred revenue under the Astellas Europe Agreement, of $1.4 million and $1.2 million for the three months ended June 30, 2026 and 2025, and $2.9 million and $2.0 million for the six months ended June 30, 2026 and 2025, respectively.

It is our best estimate that the remainder of the deferred revenue will be recognized as revenue when uncertainty is resolved, based on the performance of roxadustat product sales in the Astellas territory.

During the first quarter of 2026, we recorded $3.3 million to the drug product revenue for intermediates under the terms of the Astellas Europe Agreement and the Astellas EU Supply Agreement, and received cash during the same quarter.

In addition, we transferred bulk drug product for commercial purposes under the terms of the Astellas Europe Agreement and the Astellas EU Supply Agreement, and recognized the related fully-burdened manufacturing costs of $0.9 million as drug product revenue, and recorded $6.2 million as deferred revenue due to a high degree of uncertainty associated with the variable consideration for revenue recognition purposes.

In addition, we updated our estimate of variable consideration related to the bulk drug product transferred in prior years.

For the six months ended June 30, 2026, we updated our estimate of variable consideration related to the bulk drug product transferred in prior years.

Specifically, the change in estimated variable consideration was based on the bulk drug product held by Astellas at the period end, adjusted to reflect the changes in the estimated transfer price, forecast information, shelf-life estimates and other items.

As a result, 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 a result, we further reclassified $0.8 million from the related deferred revenue to accrued liabilities.

As of June 30, 2026, the balances related to the bulk drug product price true-up under the Astellas Europe Agreement and the Astellas EU Supply Agreement were $2.3 million in accrued liabilities, representing our best estimate that these amounts will be paid within the next 12 month.

As of December 31, 2025, we recorded $5.4 million related balance in accrued liabilities, $3.8 million of which was paid to Astellas in the first quarter of 2026.

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.

Operating Costs and Expenses

Three Months Ended March 31,

Three Months Ended June 30,

Six Months Ended June 30,

(dollars in thousands)

5 unchanged sentences

Total operating costs and expenses

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.

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

Cost of Goods Sold

Cost of goods sold 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.

Cost of goods sold for the three months ended June 30, 2026 and 2025 were immaterial.

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

Research and Development Expenses

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We recognize costs for certain development activities based on an evaluation of the progress to completion of specific tasks using information and data provided to us by our vendors and our clinical sites.

We have implemented a significant cost reduction plan in the U.S.

in the third quarter of 2024.

As a result, research and development expenses have overall decreased and may continue to decrease in certain areas over time.

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

Three Months Ended March 31,

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

Three Months Ended June 30,

Six Months Ended June 30,

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 $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:

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

• Increase of $2.2 million in clinical trials expenses associated with FG-3246 Phase 2 trials;

• Decrease of $0.8 million employee-related costs primarily due to lower headcount.

Research and development expenses decreased $0.7 million, or 4%, for the six months ended June 30, 2026, compared to the same period a year ago, primarily as a result of the net effect of the following:

• Decrease of $1.9 million employee-related costs primarily due to lower headcount;

• Decrease of $1.1 million in stock-based compensation primarily resulting from lower stock price and reduced headcount;

• Decrease of $0.8 million in drug development expenses due to lower drug substance activities and lower logistic expenses associated with manufacturing activities for FG-3246 clinical trials;

• Increase of $2.1 million in clinical trials expenses associated with FG-3246 Phase 2 trials;

• Increase of $1.6 million in outside services due to higher activities associated with FG-3246 studies in the current year period, as compared to activities related to pamrevlumab programs, which were completed and terminated in the prior year period.

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SG&A expenses also include professional fees, accounting and legal services, other outside services, recruiting fees and expenses associated with obtaining and maintaining patents.

We have implemented a significant cost reduction plan in the U.S.

in the third quarter of 2024.

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

SG&A expenses 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:

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

• Increase of $3.5 million in legal expenses primarily related to estimated indemnification costs associated with a former officer;

• Decrease of $0.7 million in equipment and facilities-related expenses due to cost control efforts.

SG&A expenses remained relatively flat for the six months ended June 30, 2026, compared to the same period a year ago, primarily as a result of the net effect of the following, respectively:

• Increase of $4.3 million in legal expenses primarily related to estimated indemnification costs associated with a former officer;

• Decrease of $1.8 million in equipment and facilities-related expenses and decrease of $1.1 million in outside services due to cost control efforts;

• Decrease of $0.6 million in audit services due to lower audit activities;

• Decrease of $0.5 million in stock-based compensation primarily resulting from lower stock price and reduced headcount.

Interest and Other, Net

Three Months Ended March 31,

Three Months Ended June 30,

Six Months Ended June 30,

(dollars in thousands)

1 unchanged sentence

Interest expense

Gain on deconsolidation of subsidiary

Interest income and other income (expenses), net

Total interest and other, net

________________________

NM = Not meaningful

Interest Expense

Interest expense represents the interest related to sale of future revenues and interest related to the Technology Development Center of the Republic of Finland product development obligations.

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

Interest expense remained relatively flat for the three and six months ended June 30, 2026, compared to the same periods a year ago.

Gain on deconsolidation of subsidiary

In April 2026, our subsidiary, FibroGen Europe, voluntarily filed for bankruptcy with the Finnish bankruptcy court.

On April 16, 2026, the Helsinki District Court declared FibroGen Europe bankrupt and appointed an estate administrator to oversee the bankruptcy estate.

As a result, we determined that we no longer maintained a controlling financial interest in FibroGen Europe and therefore deconsolidated the subsidiary effective April 16, 2026.

Upon deconsolidation, we derecognized the subsidiary’s assets and liabilities and recognized a $30.9 million gain on deconsolidation.

See Note 2, Deconsolidation of European Subsidiary , to the condensed consolidated financial statements for details.

Interest Income and Other Income (Expenses), Net

Interest income and other income (expenses), net primarily include interest income earned on our cash, cash equivalents and investments, foreign currency transaction gains (losses), remeasurement of certain monetary assets and liabilities in non-functional currency of our subsidiaries into the functional currency, realized gains (losses) on sales of investments, and other non-operating income and expenses.

Interest income and other income (expenses), net increased $0.7 million, or 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,

Interest income and other income (expenses), net increased $0.7 million, or 241%, and increased $1.4 million, or 199%, for the three and six months ended June 30, 2026, respectively, compared to the same periods a year ago, primarily due to higher interest income resulting from overall higher cash equivalents and investment balances during the current year periods.

Three Months Ended June 30,

Six Months Ended June 30,

(dollars in thousands)

Loss from continuing operations before income taxes

Provision for income taxes

Income (loss) from continuing operations before income taxes

Benefit from income taxes

Effective tax rate

Provision for income taxes for the three months ended March 31, 2026 and 2025 were immaterial.

Benefit from income taxes for the three and six months ended June 30, 2026 and 2025 were immaterial.

Based upon the weight of available evidence, which includes our historical operating performance, reported cumulative net losses since inception and expected continuing net loss, we have established a full valuation allowance against our net deferred tax assets as we do not currently believe that realization of those assets is more likely than not.

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On November 6, 2025, we received a $6.4 million payment from AstraZeneca, which is in full satisfaction of the first holdback of $6.0 million, plus $0.4 million that was an additional payment following the final net cash adjustments after closing.

On June 2, 2026, we received a $4.0 million payment from AstraZeneca, which is in full satisfaction of the final holdback.

See Note 3, Discontinued Operations and Divestiture , to the condensed consolidated financial statements for details.

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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 timely submitted a compliance plan to Nasdaq.

Kyntra Bio may also consider applying to transfer our securities to the Nasdaq Capital Market.

If we are unable to maintain compliance or transfer and regain compliance, our common stock could become subject to delisting, which could adversely affect share price, liquidity, and ability to raise capital.

Cash and cash equivalents, investments and accounts receivable totaled $100.3 million at March 31, 2026, compared to $109.4 million as of December 31, 2025.

Cash and cash equivalents, investments and accounts receivable totaled $95.7 million at June 30, 2026, compared to $109.4 million as of December 31, 2025.

Cash is invested in accordance with our investment policy, primarily with a view to liquidity and capital preservation.

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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:

Three Months Ended March 31,

Six Months Ended June 30,

Net cash provided by (used in):

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Effect of exchange rate changes on cash and cash equivalents

Net increase (decrease) in cash and cash equivalents

Net increase in cash and cash equivalents

Operating Activities

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.

Net cash used in operating activities was $17.9 million for the six months ended June 30, 2026 and consisted primarily of net loss of $3.2 million adjusted for non-operating cash items of $29.0 million, and a net increase in operating assets and liabilities of $14.4 million.

The significant non-operating cash items included gain on deconsolidation of subsidiary of $30.9 million and stock-based compensation expense of $2.1 million.

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

• 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;

• Accrued and other liabilities increased $4.0 million, driven by higher accrued legal expenses;

• Accounts payable increased $3.8 million driven by timing of invoicing and payments;

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See Note 8, Liability Related to Sale of Future Revenues , to the condensed consolidated financial statements for details;

• 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.

• Deferred revenue increased $2.5 million, driven by $6.2 million associated with the bulk drug product transferred to Astellas under the terms of the Astellas Europe Agreement and the Astellas EU Supply Agreement during the six months ended June 30, 2026;

partially offset by $2.8 million royalty revenue recognized, and $0.8 million reclassified to accrued liabilities, resulting from changes in estimated variable consideration associated with the bulk drug product transferred to Astellas.

See the Drug Product Revenue, Net section in Note 4, Collaboration Agreements, License Agreement and Revenues , to the condensed consolidated financial statements for details.

Net cash provided by operating activities was $15.4 million for the six months ended June 30, 2025 and consisted primarily of net loss of $3.0 million adjusted for non-operating cash items of $6.2 million, and a net increase in operating assets and liabilities of $12.1 million.

The significant non-operating cash items included stock-based compensation expense of $4.7 million.

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

• 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 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 $51.5 million, primarily due to the $28.5 million distribution of the above-mentioned litigation settlement during the quarter, which is fully recoverable under our insurance policies.

The decrease in prepaid expenses and other current assets was also related to the collection from Falikang during the quarter based on the arrangements under the settlement agreements between FibroGen China and AstraZeneca to settle certain historical items, which was unbilled receivables as of December 31, 2024;

• Deferred revenue increased $7.5 million, primarily related to the $10.0 million additional deferred revenue during the quarter due to changes in estimate associated with the China performance obligation;

offset by the $2.0 million royalty revenue recognized from the deferred revenue under the Astellas Europe Agreement during the period;

• Inventory decreased $4.2 million primarily driven by lower inventory production in China as we have decommissioned our API manufacturing facility in Cangzhou, China in late 2024;

• Accrued interest expense related to sale of future revenues increased $1.7 million due to the interest expense of $2.2 million accrued, offset by the interest paid, during the quarter.

• Accrued interest expense related to sale of future revenues increased $3.7 million due to the interest expense of $4.1 million accrued, offset by the interest paid of $0.5 million during the period;

• Accrued and other liabilities decreased $30.7 million, primarily driven by the $28.5 million distribution of litigation settlement related to our agreement in principle with plaintiffs to settle the class action lawsuit.

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

• Accounts payable decreased $21.7 million, primarily driven by the payments made during the quarter to AstraZeneca under the settlement agreements entered in September 2024 between FibroGen China and AstraZeneca to settle certain historical items;

• Accounts receivable increased $3.0 million, primarily driven by the billings to Falikang based on the arrangements under the above-mentioned settlement agreements and related to the increase product sales.

Investing Activities

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

Net cash provided by investing activities was $3.0 million for the three months ended March 31, 2026 and consisted primarily of $14.1 million proceeds from maturity of investments;

Net cash provided by investing activities was $20.7 million for the six months ended June 30, 2026 and consisted primarily of $31.8 million proceeds from maturity of investments and $4.0 million cash payment received from AstraZeneca, which is in full satisfaction of the final holdback related to divestiture of FibroGen International;

partially offset by $15.0 million cash used in purchases of available-for-sale securities.

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

Net cash used in investing activities was immaterial for the six months ended June 30, 2025.

Financing Activities

Financing activities primarily reflect proceeds from strategic financing arrangements, cash paid 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.

Financing activities primarily reflect proceeds from strategic financing arrangements, cash paid for payroll taxes on restricted stock unit releases, and repayments of our lease liabilities and obligations.

Net cash used in financing activities was immaterial for the six months ended June 30, 2026 and 2025, respectively.

Material Cash Requirements

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Contractual Obligations

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.

As of June 30, 2026, we had outstanding total non-cancelable purchase obligations of $5.7 million for manufacture and supply of roxadustat and $1.0 million for general purchases, all of which are expected to be paid within the next 12 months.

We expect to fulfill our commitments under these agreements in the normal course of business, and as such, no liability has been recorded.

Under the RIFA with NovaQuest, as of 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.

Under the RIFA with NovaQuest, as of June 30, 2026, we had $70.7 million of liability related to sale of future revenues in the condensed consolidated balance sheets, $0.2 million of which we anticipate to pay within the next 12 month.

Based on our current estimates of drug product revenue and revenue from milestone payments under the Astellas Agreements, and taking into the consideration of the terms under the RIFA, we anticipate to reach a payment cap up to $125.0 million by 2031.

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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 months ended March 31, 2026 compared with the disclosures in Part II, Item 7 of our 2025 Form 10-K.

There have been no material changes in our critical accounting policies, estimates and judgments during the three and six months ended June 30, 2026 compared with the disclosures in Part II, Item 7 of our 2025 Form 10-K.

QUANTITATIVE AND QUALITAT IVE DISCLOSURES ABOUT MARKET RISK.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis