What changed in this filing

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Item 1. Legal Proceedings

2026-08-13 compared with 2026-05-12 · 20 added, 26 removed, 845 unchanged (5% of the section changed)

2 unchanged sentences

We recognize accruals for any legal action when we conclude that a loss is probable and reasonably estimable.

We did not have any material accruals for any active legal action in our condensed consolidated balance sheet as of March 31, 2026, as we could not predict the ultimate outcome of these matters, or reasonably estimate the potential exposure.

We did not have any material accruals for any active legal action in our condensed consolidated balance sheet as of June 30, 2026, as we could not predict the ultimate outcome of these matters, or reasonably estimate the potential exposure.

See Note 10, Commitments and Contingencies , to the condensed consolidated financial statements for details.

45 unchanged sentences

International Risks

• Within the next year, we may face costs from the wind-up of the Cayman Subsidiary (as defined below), and may not receive some of the AZ Holdbacks (as defined below) related to the sale of FibroGen International and its subsidiaries.

• Changes in U.S.

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Moreover, for any clinical trial to support a New Drug Application / Biologics License Application submission for approval, the U.S.

Food and Drug Administration (“FDA”) and foreign regulatory authorities require compliance with regulations and standards (including good clinical practices (“GCP”) requirements for designing, conducting, monitoring, recording, analyzing, and reporting the results of clinical trials) to ensure that (1) the data and results from trials are credible and accurate;

Food and Drug Administration (“FDA”) and foreign regulatory authorities require compliance with regulations and standards (including Good Clinical Practice (“GCP”) requirements for designing, conducting, monitoring, recording, analyzing, and reporting the results of clinical trials) to ensure that (1) the data and results from trials are credible and accurate;

and (2) that the rights, integrity and confidentiality of trial participants are protected.

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Even if we do obtain regulatory approval, our product candidates may be approved for narrower indications than we request, approval may be contingent on the performance of costly post-marketing clinical trials, or approval may require labeling that does not include the labeling claims necessary or desirable for the successful commercialization of that product candidate.

In addition, if our product candidates produce undesirable side effects or safety issues, the FDA may require the establishment of Risk Evaluation and Mitigation Strategy (or other regulatory authorities may require the establishment of a similar strategy), that may restrict distribution of our approved products, if any, and impose burdensome implementation requirements on us.

Any of the foregoing scenarios could materially harm the commercial prospects for our product candidates.

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We, or our collaboration partner, may not be able to accurately forecast clinical or commercial supply requirements and we may not meet or we may exceed our requirements as to quantities, scale-up, yield, cost, potency or quality in compliance with cGMP.

There is a general risk of delayed drug supply due to delays experienced by any third-party provider in the supply chain, including raw material and components suppliers, export and customs locations, and shipping companies.

There is a general risk of delayed drug supply from any third-party provider in the supply chain, including raw material and components suppliers, export and customs locations, and shipping companies.

Any delay or interruption in the supply of our product candidates or products could have a material adverse effect on our business and operations.

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We or our partners may add or change manufacturers, change our manufacturing processes, or change packaging specifications to accommodate changes in regulations, manufacturing equipment or to account for different processes at new or second source suppliers.

Manufacturing changes made to one of our drugs or drug candidates, include, but are not limited to, demonstration of comparability to regulatory approved/ in approval products and processes, additional clinical trials, delays in development or commercialization, earlier expiration dates, shorter shelf life, or specification failures, and those changes may materially impact our operations and potential profitability.

Manufacturing changes made to one of our drugs or drug candidates, include, but are not limited to, demonstration of comparability to approved/ in approval products and processes, additional clinical trials, delays in development or commercialization, earlier expiration dates, shorter shelf life, or specification failures, and those changes may materially impact our operations and potential profitability.

This includes the scenario that the change may be unsuccessful and cause delays or other negative impact.

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• natural disasters, such as pandemics, floods, storms, earthquakes, tsunamis, and droughts, or accidents such as fire, that affect facilities, possibly limit or postpone production, and increase costs;

• failure to obtain a license to proprietary starting materials.

• failure to obtain a license to procure proprietary starting materials.

Kyntra Bio may also elect to transition its manufacturing responsibilities to another party.

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In addition, even if we are able to provide positive data with respect to certain analyses, regulatory authorities may not include such claims on any approved labeling.

The failure to obtain regulatory approval, or any label, population or other approval limitations in any jurisdiction, may significantly limit or delay our ability to generate revenues, and any failure to obtain such approval for all of the indications and labeling claims we deem desirable could reduce our potential revenue.

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

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In some countries, our partner or we may be required to conduct a clinical trial or other studies that compare the cost-effectiveness of our product candidates to other available products in order to obtain or maintain reimbursement or pricing approval.

In the U.S., government efforts to implement Most Favored Nation pricing policies, which would tie the price of certain drugs to the lowest price paid for the same drug in other economically comparable countries, could result in similar downward pricing pressure domestically if such policies are adopted and applied to our products.

The Inflation Reduction Act of 2022 established a Medicare drug price negotiation program administered by CMS, under which selected drugs are subject to government-negotiated “maximum fair prices.” Small-molecule drugs such as roxadustat become eligible for selection earlier in their lifecycle than biologics.

If any of our products become subject to this program, or if this framework is expanded, our revenue and our collaboration partners’ commercialization economics could be adversely affected.

Publication of discounts by third-party payors or authorities may lead to further pressure on the prices or reimbursement levels within the country of publication and other countries.

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and all other countries in the world, other than the People’s Republic of China (“China”), not previously licensed to Astellas (the “AstraZeneca U.S./RoW Agreement”) was terminated on February 25, 2024 as amended and restated on August 29, 2025 (except for South Korea).

Our collaboration agreement with AstraZeneca for the development and commercialization of roxadustat for the treatment of anemia in China (the “AstraZeneca China Agreement”) culminated as a result of the completion of the sale of FibroGen International and its subsidiaries pursuant to the share purchase agreement entered into by the Company and AstraZeneca Treasury Limited on February 20, 2025, as amended on August 29, 2025 (the “Share Purchase Agreement”).

(“FibroGen International”) and its subsidiaries pursuant to the share purchase agreement entered into by the Company and AstraZeneca Treasury Limited on February 20, 2025, as amended on August 29, 2025 (the “Share Purchase Agreement”).

This eliminates any additional potential milestones or other payments AstraZeneca could have made under the AstraZeneca U.S./RoW Agreement or the AstraZeneca China Agreement.

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• reduced control and additional burdens of oversight as a result of using third-party manufacturers and distributors for all aspects of manufacturing activities, including regulatory compliance and quality control and quality assurance;

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

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

• significant financial commitments we may be required to make with third-party manufacturers for early-stage clinical or pre-clinical programs that may fail to produce scientific results that would justify further development (without the ability to mitigate the manufacturing investments);

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International Risks

Within the next year, we may face costs from the wind-up of the Cayman Subsidiary (as defined below), and may not receive some of the AZ Holdbacks (as defined below) related to the sale of FibroGen International and its subsidiaries.

As disclosed in our Current Report on Form 8‑K filed in February 20, 2025, we agreed to two holdback amounts from the consideration paid by AstraZeneca Treasury Limited (the “AZ Holdbacks”) in connection with the sale of FibroGen International and its subsidiaries.

The AZ Holdbacks were subject to specified conditions, potential set‑offs, indemnification claims, and dispute processes.

While we received all of the $6.0 million holdback (plus an additional $0.4 million favorable net cash adjustment), we may not receive all of the $4.0 million remaining AZ holdback.

We may not receive some of the second AZ Holdback, the amount may be reduced, and/or the timing of any release may be delayed, including due to claims or issues that are outside our control.

In addition, there is a possibility that liabilities related to the sale of FibroGen International and its subsidiaries — such as post‑closing adjustments, taxes, third‑party or employee claims, product or commercial liabilities, compliance matters, or other indemnifiable losses—could exceed the AZ Holdback or fall outside its scope.

After the final AZ Holdback is received or finalized, we are planning on winding up FibroGen International (Cayman) Limited (the “Cayman Subsidiary”).

The wind‑up involves legal, regulatory, tax, accounting, and administrative steps.

The timing, cost, and outcome of these steps are uncertain and may be impacted by claims or demands from stakeholders, which could require us to establish or increase reserves, provide additional documentation, or engage in dispute resolution or litigation.

Any of these issues could delay any further distributions to shareholders of the Cayman Subsidiary and require additional management attention.

Changes in U.S.

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Our loss from continuing operations were $58.2 million and $153.1 million for the year ended December 31, 2025, and 2024, respectively.

As of March 31, 2026, we had an accumulated deficit of $1.7 billion.

As of March 31, 2026, we had capital resources from cash and cash equivalents of $37.0 million and short-term and long-term investments of $58.3 million.

As of June 30, 2026, we had an accumulated deficit of $1.7 billion.

As of June 30, 2026, we had capital resources from cash and cash equivalents of $50.6 million and short-term and long-term investments of $44.7 million.

Despite the commercialization efforts of Astellas for roxadustat for the treatment of anemia caused by chronic kidney disease, we anticipate we will continue to incur losses on an annual basis for the foreseeable future.

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Legal proceedings, regardless of their merits or their ultimate outcomes, are costly, divert management’s attention and may materially adversely affect our business, results of operations, financial condition, prospects, and stock price.

Such costs may include indemnification for proceedings against our current or former officers, and there is one ongoing proceeding against a former officer where costs could be material but are uncertain at this time.

Such costs include indemnification for proceedings against our current or former officers, and there is one ongoing proceeding against a former officer where costs are now material as set forth in the Indemnification Agreements section under Note 10, Commitments and Contingencies .

Although we maintain insurance for certain potential liabilities, such insurance does not cover all types and amounts of potential liabilities and is subject to various exclusions and caps on amounts recoverable.

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The market price of our common stock has at times experienced price volatility and may continue to be volatile.

For example, during the 12-month period ended March 31, 2026, the closing price of our common stock on the Nasdaq Global Select Market has ranged from $5.16 per share to $12.38 per share.

For example, during the 12-month period ended June 30, 2026, the closing price of our common stock on the Nasdaq Global Select Market has ranged from $5.25 per share to $12.43 per share.

In general, pharmaceutical, biotechnology and other life sciences company stocks have been highly volatile in the current market.

29 unchanged sentences

The notification received has no immediate effect on the listing of Kyntra Bio’s common stock on Nasdaq Global Select Market.

Under the Nasdaq Rules, we have 45 days (May 18, 2026) to submit a plan to regain compliance and if such plan is accepted, Nasdaq may grant us with an extension of up to 180 days (September 29, 2026) to evidence compliance.

We timely submitted a plan to Nasdaq to regain compliance and if such plan is accepted, Nasdaq may grant us with an extension of up to 180 days (September 29, 2026) to evidence compliance.

Per Listing Rule 5810(c)(2)(D), we may submit a plan that demonstrates current or near-term compliance with the listing requirements relating to stockholders’ equity or market value of listed securities.

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If we are unable to maintain compliance with the continued listing requirements of the Nasdaq Capital Market following such a transfer, or if we are unable to transfer and unable to regain compliance with the Nasdaq Global Select Market, our common stock could become subject to delisting.

Delisting from the Nasdaq Global Select Market or any Nasdaq market could make trading our common stock more difficult for investors, potentially leading to declines in our share price and liquidity.

Delisting from the Nasdaq Global Select Market or any Nasdaq market could make trading our

common stock more difficult for investors, potentially leading to declines in our share price and liquidity.

In that event, the risks with respect to delisting include limited trading markets, ineligibility to sell securities under our current S-3 registration statement under certain circumstances, potential quotation on over-the-counter markets, and the possible application of “penny stock” rules (as “penny stock” is defined in the Exchange Act, and including coverage under Rule 15g-9 of the Exchange Act), and could further adversely affect the market for and value of our common stock.

93 unchanged sentences

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 1. Legal Proceedings