KYNTRA BIO, INC.

Previous wording

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.

Current wording

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.

Previous wording

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.

Current wording

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.

Previous wording

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

Current wording

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

Previous wording

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.

Current wording

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).

Previous wording

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:

Current wording

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:

Previous wording

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

Current wording

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

Previous wording

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

Current wording

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

Previous wording

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

Current wording

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

Previous wording

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

Current wording

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

Previous wording

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.

Current wording

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.

Previous wording

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.

Current wording

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.

Previous wording

An exploratory sub-study will evaluate 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.

Current wording

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.

Previous wording

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.

Current wording

The diagnosed prevalence of MDS in the U.S. is estimated to be approximately 74,000, and continues to rise as more therapies become available and patients are living longer with MDS. Annual incidence rates are estimated to be 20,000 adults in the U.S., 70% of whom are considered lower-risk MDS.

Previous wording

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.

Current wording

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

Previous wording

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.

Current wording

As previously disclosed, more patients in the roxadustat arm (47.5% of 80 patients) achieved transfusion independence for 56 consecutive days (within the first 28 weeks) than the placebo arm (33.3% of 57 patients); however, the p-value was not significant. Our European Hematology Association (EHA) Congress 2026 presentation highlighted data from a post hoc analysis of the entire trial population, demonstrating that roxadustat led to similar rates of transfusion independence in both RS+ and RS- patients. In RS- patients, which comprised 84 of the 140 patients enrolled in the trial, treatment with roxadustat led to transfusion independence for ≥8 weeks (within the first 28 weeks) in 48% of patients vs. 28% for placebo.

Previous wording

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).

Current wording

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.

Previous wording

Exclusive License and Option to Acquire Fortis Therapeutics

Current wording

Exclusive License and Option to Acquire Fortis

Previous wording

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.

Current wording

In 2018, we and Astellas entered into an amendment to the Astellas Japan Agreement that allows Astellas to manufacture roxadustat drug product for commercialization in Japan (the “Astellas Japan Amendment”). The related drug product revenue was $(2.9) million for the three months ended June 30, 2026, and immaterial for the three months ended June 30, 2025, and ($5.1) million and $1.8 million for the six months ended June 30, 2026 and 2025, respectively.

Previous wording

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.

Current wording

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

Previous wording

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.

Current wording

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.

Previous wording

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.

Current wording

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.

Previous wording

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.

Current wording

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.

Previous wording

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.

Current wording

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.

Previous wording

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 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.

Current wording

For the six months ended June 30, 2026, we updated our estimate of variable consideration related to the bulk drug product transferred in prior years. Specifically, the change in estimated variable consideration was based on the bulk drug product held by Astellas at the period end, adjusted to reflect the changes in the estimated transfer price, forecast information, shelf-life estimates and other items. As a result, we further reclassified $0.8 million from the related deferred revenue to accrued liabilities. As of June 30, 2026, the balances related to the bulk drug product price true-up under the Astellas Europe Agreement and the Astellas EU Supply Agreement were $2.3 million in accrued liabilities, representing our best estimate that these amounts will be paid within the next 12 month. As of December 31, 2025, we recorded $5.4 million related balance in accrued liabilities, $3.8 million of which was paid to Astellas in the first quarter of 2026.

Previous wording

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.

Current wording

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.

Previous wording

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.

Current wording

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.

Previous wording

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

Current wording

Research and development expenses consist of independent research and development costs and the gross amount of costs associated with work performed under collaboration agreements. Research and development expenses include employee-related expenses for research and development functions, expenses incurred under agreements with clinical research organizations, other clinical and preclinical costs and allocated direct and indirect overhead costs, such as facilities costs, information technology costs and other overhead. We expense research and development costs as incurred. We recognize costs for certain development activities based on an evaluation of the progress to completion of specific tasks using information and data provided to us by our vendors and our clinical sites.

Previous wording

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

Current wording

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

Previous wording

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

Current wording

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

Previous wording

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

Current wording

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

Previous wording

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.

Current wording

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.

Previous wording

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

Current wording

Selling, general and administrative (“SG&A”) expenses consist primarily of employee-related expenses for executive, operational, finance, legal, compliance, and human resource functions. SG&A expenses also include professional fees, accounting and legal services, other outside services, recruiting fees and expenses associated with obtaining and maintaining patents.

Previous wording

Decrease of $1.1 million in equipment and facilities-related expenses due to cost control efforts; and

Current wording

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

Previous wording

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

Current wording

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

Previous wording

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.

Current wording

Interest expense represents the interest related to sale of future revenues and interest related to the Technology Development Center of the Republic of Finland product development obligations. Interest expense remained relatively flat for the three and six months ended June 30, 2026, compared to the same periods a year ago.

Previous wording

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.

Current wording

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.

Previous wording

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

Current wording

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

Previous wording

Upon the close of the sale of FibroGen International and its subsidiaries to AstraZeneca Treasury Limited on August 29, 2025, we received $210.4 million in cash paid at closing, and a total of $10.0 million cash payable by AstraZeneca at the closing subject to holdbacks of: (i) a $6.0 million holdback to offset final net cash adjustments which will be released following a customary adjustment process approximately 90 days post-closing (as such time may be extended for the parties to mutually agree upon final adjustments), and (ii) a $4.0 million holdback to satisfy any indemnity claims, which will be released, net of any claims paid or unresolved, nine months after the closing. On November 6, 2025, we received a $6.4 million payment from AstraZeneca, which is in full satisfaction of the first holdback of $6.0 million, plus $0.4 million that was an additional payment following the final net cash adjustments after closing. See Note 2, Discontinued Operations and Divestiture, to the condensed consolidated financial statements for details.

Current wording

Upon the close of the sale of FibroGen International and its subsidiaries to AstraZeneca Treasury Limited on August 29, 2025, we received $210.4 million in cash paid at closing, and a total of $10.0 million cash payable by AstraZeneca at the closing subject to holdbacks of: (i) a $6.0 million holdback to offset final net cash adjustments which will be released following a customary adjustment process approximately 90 days post-closing (as such time may be extended for the parties to mutually agree upon final adjustments), and (ii) a $4.0 million holdback to satisfy any indemnity claims, which will be released, net of any claims paid or unresolved, nine months after the closing. On November 6, 2025, we received a $6.4 million payment from AstraZeneca, which is in full satisfaction of the first holdback of $6.0 million, plus $0.4 million that was an additional payment following the final net cash adjustments after closing. On June 2, 2026, we received a $4.0 million payment from AstraZeneca, which is in full satisfaction of the final holdback. See Note 3, Discontinued Operations and Divestiture, to the condensed consolidated financial statements for details.

Previous wording

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.

Current wording

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.

Previous wording

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.

Current wording

Cash and cash equivalents, investments and accounts receivable totaled $95.7 million at June 30, 2026, compared to $109.4 million as of December 31, 2025. Cash is invested in accordance with our investment policy, primarily with a view to liquidity and capital preservation. Investments, consisting of available-for-sale securities, and stated at fair value, are also available as a source of liquidity.