What changed in this filing

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Item 1A. Risk Factors

2026-07-30 compared with 2026-04-29 · 60 added, 62 removed, 802 unchanged (13% of the section changed)

7 unchanged sentences

Our ability to generate meaningful revenue from PYRUKYND® and AQVESME™ will depend heavily on our successful development and commercialization of the product.

We generated $20.7 million and $8.7 million of net product revenues from sales of PYRUKYND® and AQVESME™ in the three months ended March 31, 2026 and 2025, respectively.

We generated $65.5 million and $21.2 million of net product revenues from sales of PYRUKYND® and AQVESME™ in the six months ended June 30, 2026 and 2025, respectively.

We commercially launched AQVESME™ in the United States in late January 2026.

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If we experience significant delays or an inability to successfully develop and commercialize PYRUKYND® and AQVESME™, our business would be materially harmed.

We depend heavily on the success of our clinical-stage product candidates, including the potential approval of mitapivat for the treatment of thalassemia in the EU, or SCD in the United States and in other jurisdictions.

We depend heavily on the success of our clinical-stage product candidates, including the potential approval of mitapivat for the treatment of SCD in the United States and in other jurisdictions.

Clinical trials of our product candidates may not be successful for a number of important reasons.

If we or our collaborators are unable to commercialize our product candidates or experience significant delays in doing so, our business will be materially harmed.

We have invested a significant portion of our efforts and financial resources in the identification of our product candidates and the development of our most advanced clinical programs, including mitapivat and tebapivat.

We have invested a significant portion of our efforts and financial resources in the identification of our product candidates and the development of our most advanced clinical programs.

Our ability to generate meaningful product revenue will depend heavily on the successful clinical development and eventual commercialization of our current and any future product candidates, including mitapivat.

We cannot be certain that we will obtain marketing approval of mitapivat in jurisdictions with pending or potential future marketing applications for thalassemia, nor can we be certain that we will obtain marketing approval of mitapivat for SCD or for any other indication.

We cannot be certain that we will obtain marketing approval of mitapivat for SCD in the United States or in other jurisdictions, nor can we be certain that we will obtain marketing approval of any other product candidate for any other indication.

We, and any collaborators, are not permitted to commercialize, market, promote or sell any product candidate in the United States without obtaining marketing approval from the FDA.

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In December 2016, we withdrew our IND for AG-519, our second PK activator, following verbal notification of a clinical hold from the FDA relating to a previously disclosed case of drug-induced cholestatic hepatitis which occurred in our phase 1 clinical trial of AG-519 in healthy volunteers.

Although these decisions and this hepatic adverse event finding do not affect our ongoing clinical trials for mitapivat or tebapivat, we cannot provide any assurances that there will not be other treatment-related severe adverse events in our other clinical trials, or that our other trials will not be placed on clinical hold in the future.

Although these decisions and this hepatic adverse event finding do not affect our ongoing clinical trials, we cannot provide any assurances that there will not be other treatment-related severe adverse events in our other clinical trials, or that our other trials will not be placed on clinical hold in the future.

Our failure to successfully complete clinical trials of our product candidates and obtain regulatory approval to market any of our product candidates could significantly harm our business.

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As part of our strategy, we plan to prioritize in-licensing or acquiring assets for future pipeline growth.

For example, in July 2023, we entered into a license agreement with Alnylam for the development and commercialization of products containing or comprised of an siRNA development candidate discovered by Alnylam and targeting the TMPRSS6 gene, and we are developing a product candidate, AG-236, for the potential treatment of patients with PV, and in June 2026, we entered into a license agreement with Oscotec for the development and commercialization of cevidoplenib, a novel, highly selective, oral SYK inhibitor for the potential treatment of ITP and other autoimmune indications.

Our ability to successfully in-license or acquire assets and develop product candidates following such transactions is unproven.

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For example, we are responsible for paying up to $130.0 million in potential development and regulatory milestones, in addition to sales milestones as well as tiered royalties on annual net sales, if any, of any licensed products, under our license agreement with Alnylam.

We are also responsible for paying up to $140.0 million in potential development and regulatory milestone payments, in addition to sales milestone payments as well as tiered royalties on future net sales, if any, of licensed products under our license agreement with Oscotec.

Further, any in-licensing transaction or acquisitions we undertake may not strengthen our competitive position, and these transactions may be viewed negatively by customers or investors.

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We could incur losses resulting from undiscovered liabilities of the acquired business, product or technology that are not covered by the indemnification we may obtain from the seller.

In addition, we may not be able to successfully integrate the acquired personnel, technologies and operations into our existing business in an effective, timely and non-disruptive manner.

In addition, we may

not be able to successfully integrate the acquired personnel, technologies and operations into our existing business in an effective, timely and non-disruptive manner.

Such transactions may also divert management attention from day-to-day responsibilities, increase our expenses and reduce our cash available for operations and other uses.

We cannot ensure that following any

transaction we would achieve the expected synergies to justify the transactions.

We cannot ensure that following any transaction we would achieve the expected synergies to justify the transactions.

We cannot predict the number, timing or size of future transactions or the effect that any such transactions might have on our operating results.

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Even if we or our collaborators believe that the results of clinical trials for our product candidates warrant marketing approval, the FDA or comparable foreign regulatory authorities may disagree and may not grant marketing approval of our product candidates.

In some instances, there can be significant variability in safety or efficacy results between different clinical trials of the same product candidate due to numerous factors, including changes in trial procedures set forth in protocols, differences in the size and type of the patient populations, changes in and adherence to the dosing regimen and other clinical trial protocols and the

rate of dropout among clinical trial participants.

If we fail to receive positive results in clinical trials of our product candidates, the development timeline and regulatory approval and commercialization prospects for our most advanced product candidates, and, correspondingly, our business and financial prospects would be negatively impacted.

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It is possible that our clinical trials, or those of any collaborators, may indicate an apparent positive effect of a product candidate that is greater than the actual positive effect, if any, or alternatively fail to identify undesirable side effects.

If, following approval of a product candidate, including PYRUKYND® and AQVESME™, we, or others, discover that the

product is less effective than previously believed or causes undesirable side effects that were not previously identified, any of the following adverse events could occur:

following approval of a product candidate, including PYRUKYND® and AQVESME™, we, or others, discover that the product is less effective than previously believed or causes undesirable side effects that were not previously identified, any of the following adverse events could occur:

• regulatory authorities may withdraw their approval of the product or seize the product;

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• we may be subject to fines, injunctions or the imposition of civil or criminal penalties;

• regulatory authorities may require the addition of warnings on the product label, require a REMS or or modify an existing REMS;

• regulatory authorities may require the addition of warnings on the product label, require a REMS or modify an existing REMS;

• we, or any collaborators, may be required to create a Medication Guide outlining the risks of the previously unidentified side effects for distribution to patients;

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• our reputation may suffer.

For example, the USPI for PYRUKYND® includes a warning regarding the risk of potential hepatoceullar injury, and the USPI for AQVESME™ contains a boxed warning regarding the potential for hepatocellular injury.

For example, the USPI for PYRUKYND® includes a warning regarding the risk of potential hepatocellular injury, and the USPI for AQVESME™ contains a boxed warning regarding the potential for hepatocellular injury.

In addition, to mitigate the risk of hepatocellular injury, AQVESME™ is available only through the REMS program approved by the FDA.

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We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do.

We face competition with respect to PYRUKYND®, AQVESME™, mitapivat, tebapivat and our other product candidates, and we will face competition with respect to any product candidates that we may seek to develop or commercialize in the future.

We face competition with respect to PYRUKYND®, AQVESME™, mitapivat, AG-181, AG-236, cevidoplenib and our other product candidates, and we will face competition with respect to any product candidates that we may seek to develop or commercialize in the future.

Potential competitors may include major pharmaceutical companies, specialty pharmaceutical companies, biotechnology companies, academic institutions, government agencies and other public and private research organizations that conduct research, seek patent protection and establish collaborative arrangements for research, development, manufacturing and commercialization.

There are a number of large pharmaceutical and biotechnology companies that currently market and sell products or are pursuing the development of products for the treatment of the indications for which we are developing our product or our product candidates, such as PK deficiency, thalassemia, SCD, LR MDS, PKU, and PV.

For example, Merck and Bristol-Myers Squibb Company, or BMS, are marketing a therapy to treat beta thalassemia and LR MDS, and are conducting clinical trials for alpha thalassemia and LR MDS patients that are erythropoiesis-stimulating agent naïve and non-transfusion dependent;

Geron Corporation has an FDA approved treatment for adults with LR MDS with transfusion-dependent anemia;

Halia is developing HT-6184 for the treatment of LR-MDS;

Takeda Pharmaceutical Company Limited, or Takeda, in collaboration with Keros Therapeutics, Inc., are developing a therapy to treat LR-MDS;

Novartis International AG is marketing a therapy and has another molecule in clinical trials to treat SCD;

For example, Merck and Bristol-Myers Squibb Company, or BMS, are marketing a therapy to treat beta-thalassemia, and are conducting a clinical trial for alpha thalassemia patients that are erythropoiesis-stimulating agent naïve and non-transfusion dependent;

Geron Corporation has an FDA approved treatment for adults with transfusion-dependent anemia;

Novartis International AG is marketing therapies for SCD, PV and ITP and has another molecule in clinical trials to treat SCD and ITP;

Emmaus Life Sciences is marketing a therapy to treat SCD;

BioMarin Pharmaceutical Inc.

is marketing and conducting clinical trials for therapies to treat PKU;

is marketing and conducting clinical trials for

therapies to treat PKU;

PTC has an approved treatment for PKU;

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Novo Nordisk A/S is conducting clinical trials for the treatment of alpha- and beta-thalassemia and SCD;

Sanofi is conducting clinical trials for a therapy in SCD;

Sanofi is marketing a therapy to treat ITP and conducting clinical trials for a therapy in SCD;

Genetix Biotherapeutics Inc.

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Vertex, with CRISPR, is marketing a gene therapy targeting SCD and transfusion-dependent beta-thalassemia;

DISC Medicine, Inc., or DISC, is conducting a clinical trial for a potential treatment for SCD;

Fulcrum Therapeutics Inc.

is conducting clinical trials for a potential treatment for SCD;

DISC Medicine, Inc., or DISC, is conducting a clinical trial for a potential treatment for SCD, beta thalassemia and PV;

BMS is conducting clinical trials for a potential treatment for SCD;

Argenx SE is marketing a therapy and conducting clinical trials for a therapy in ITP;

Rigel Pharmaceuticals, Inc.

is marketing a therapy to treat ITP;

Takeda is conducting clinical trials for a potential treatment for ITP;

Otsuka Pharmaceutical Co., Ltd., NGGT Inc., and Maze Therapeutics, Inc.

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The FDA may not approve an ANDA or 505(b)(2) NDA until any applicable period of regulatory exclusivity for the reference-listed drug has expired, subject to certain exceptions.

negatively impact our future revenue, profitability and cash flows and substantially limit our ability to obtain a return on our investments in those product candidates.

In the event that a generic or follow-on manufacturer is somehow able to obtain FDA approval without adherence to the periods of regulatory exclusivity, the competition that our approved products may face from generic and follow-on versions could negatively impact our future revenue, profitability and cash flows and substantially limit our ability to obtain a return on our investments in those product candidates.

In addition, if there are patents listed for our drug products in the Orange Book, ANDAs and 505(b)(2) NDAs would be required to include a certification for every Orange Book-listed patent, declaring whether the patent is absent, expired, not challenged, or invalid/not infringed (Paragraph I, II, III, or IV, respectively).

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We face challenges as a less diversified company.

The success of our rare disease business is subject to various risks and uncertainties, including the possibility that we may not be able to successfully commercialize PYRUKYND® and AQVESME™, the possibility that mitapivat is not approved for SCD, the possibility that mitapivat is not approved for thalassemia in additional jurisdictions, the possibility of adverse post-approval, clinical and other developments in respect of PYRUKYND®, AQVESME™, mitapivat, tebapivat or our other product candidates, and unanticipated changes in applicable laws and regulations that may adversely affect the rare disease business.

The success of our rare disease business is subject to various risks and uncertainties, including the possibility that we may not be able to successfully commercialize PYRUKYND® and AQVESME™, the possibility that mitapivat is not approved for SCD, the possibility of adverse post-approval, clinical and other developments in respect of PYRUKYND®, AQVESME™, mitapivat or our other product candidates, and unanticipated changes in applicable laws and regulations that may adversely affect the rare disease business.

We may be more susceptible to changing market conditions, including fluctuations and risks particular to the markets for patients with rare diseases, than a more diversified company, which could adversely affect our business, financial condition and results of operations.

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• the scope, progress, results and costs of preclinical development, laboratory testing and clinical trials for our product candidates;

• the costs associated with in-licensing or acquiring assets for pipeline growth, including the amount and timing of future milestone and royalty payments payable to Alnylam pursuant to the license agreement;

• the costs associated with in-licensing or acquiring assets for pipeline growth, including the amount and timing of future milestone and royalty payments payable to Alnylam and Oscotec pursuant to the respective license agreements;

• the costs, timing and outcome of regulatory review of our product candidates;

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We have a history of incurring operating losses.

Our net loss for the three months ended March 31, 2026 was $99.1 million and for the three months ended March 31, 2025 was $89.3 million.

As of March 31, 2026, we had an accumulated deficit of $660.8 million.

Our net loss for the six months ended June 30, 2026 was $199.8 million and for the six months ended June 30, 2025 was $201.3 million.

As of June 30, 2026, we had an accumulated deficit of $761.5 million.

We are commercializing PYRUKYND® for the treatment of hemolytic anemia in adults with PK deficiency in the United States.

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If we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis.

Our failure to become and remain profitable would decrease the value of our

company and could impair our ability to raise capital, maintain our research and development efforts, expand our business or continue our operations.

Our failure to become and remain profitable would decrease the value of our company and could impair our ability to raise capital, maintain our research and development efforts, expand our business or continue our operations.

A decline in the value of our company could also cause our stockholders to lose all or part of their investment.

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Department of Defense as Chinese Military Companies Operating in the United States as BCCs.

The legislation allows for other biotechnology companies, possibly including WuXi entities, to be added to the federal funding prohibitions at a later time.

On February 13, 2026, the Department of Defense published an updated list, which included WuXi, but then abruptly withdrew the list.

The implications of this action remain unclear.

The legislation allows for other biotechnology companies to be added to the federal funding prohibitions at a later time.

On June 8, 2026, the Department of Defense published an updated list, which included WuXi AppTec.

If either we or any third parties on which we rely are adversely impacted by restrictions resulting from the emergence of public health epidemics, by rising global energy costs or energy shortages or rationing and/or geopolitical events, our supply chain may be disrupted, limiting our ability to manufacture our product candidates for our clinical trials and research and development operations and our product for commercialization.

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An ANDA containing a Paragraph IV certification for mitapivat was submitted on February 17, 2026.

We have received notice of such certification and we intend to file a timely infringement suit.

We received notice of such certification and filed a timely infringement suit.

We may receive additional notices of paragraph IV certifications in the future and we may take similar actions with respect to those ANDAs.

In addition, a court may decide that a patent of ours is invalid or unenforceable, or may refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover the technology in question.

In addition, a court or a patent office such as the USPTO or European Patent Office may decide that a patent of ours is invalid or unenforceable, or may refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover the technology in question.

An adverse result in any litigation proceeding could put one or more of our patents at risk of being invalidated or interpreted narrowly.

Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation.

Third parties may initiate legal proceedings alleging that we or our collaborators are infringing their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on the success of our business.

Third parties may initiate legal proceedings alleging that we or our collaborators are infringing their intellectual property rights or that our patents are invalid, the outcome of which would be uncertain and could have a material adverse effect on the success of our business.

The biotechnology and pharmaceutical industries are characterized by extensive litigation regarding patents and other intellectual property rights.

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After separate oral proceedings, both European patents were upheld by the European Opposition Division in written decisions in November 2025 and January 2026, respectively.

These decisions have been appealed by the opponents.

These decisions have been appealed by the opponents and we have filed or will be filing timely responses.

In addition, a request for Inter Partes Review in connection with US 11,878,049 was filed with the USPTO on May 18, 2026, and we intend to take all necessary steps to defend our patent.

Third parties may assert infringement claims against us based on existing patents or patents that may be granted in the future.

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Even if resolved in our favor, litigation or other legal proceedings relating to intellectual property claims may cause us to incur significant expenses, and could distract our technical and management personnel from their normal responsibilities.

In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments and if securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of our common stock.

In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments and if

securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of our common stock.

Such litigation or proceedings could substantially increase our operating losses and reduce the resources available for development activities or any future sales, marketing or distribution activities.

We may not have sufficient financial or other resources to adequately conduct such litigation or proceedings.

Some of our competitors may be able to

sustain the costs of such litigation or proceedings more effectively than we can because of their greater financial resources and more mature and developed intellectual property portfolios.

Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their greater financial resources and more mature and developed intellectual property portfolios.

Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a material adverse effect on our ability to compete in the marketplace.

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Depending on the extent of these or any other FDA- or EMA-required trials or studies, approval of any marketing applications that we submit may be delayed by several years, or may require us to expend more resources than we planned.

It is also possible that additional trials or studies, if performed and completed, may not be considered sufficient by the FDA or EMA to approve any marketing applications.

It is also possible that additional trials

or studies, if performed and completed, may not be considered sufficient by the FDA or EMA to approve any marketing applications.

For example, to mitigate the risk of hepatocellular injury, AQVESME™ is available only through the REMS program approved by the FDA.

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Failure to obtain marketing approval in foreign jurisdictions would prevent our medicines from being marketed in such jurisdictions and any of our medicines that are approved for marketing in such jurisdictions will be subject to risk associated with foreign operations.

In December 2024, we announced that we submitted an MAA to the EMA for PYRUKYND® for the treatment of adult patients with non-transfusion dependent and transfusion-dependent alpha- or beta-thalassemia.

In October 2025, we announced that the CHMP of the EMA adopted a positive opinion for the new indication for PYRUKYND® in adults for the treatment of anemia associated with transfusion-dependent and non-transfusion-dependent alpha- or beta-thalassemia.

The European Commission is now reviewing the CHMP’s opinion, with the final decision expected in the first half of 2026.

In order to market and sell our medicines in the EU and many other foreign jurisdictions, we or our collaborators must obtain separate marketing approvals and comply with numerous and varying regulatory requirements.

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Moreover, approval by the FDA does not ensure approval by regulatory authorities in other countries or jurisdictions, and approval by one regulatory authority outside the United States does not ensure approval by regulatory authorities in other countries or jurisdictions or by the FDA.

Although we have received marketing authorization for PYRUKYND® for the treatment of adults with PK deficiency in the EU and Great Britain and for PYRUKYND® for the treatment of adult patients with non-transfusion dependent and transfusion-dependent alpha- or beta-thalassemia in Saudi Arabia and the United Arab Emirates, we may not be able to file for additional marketing approvals and may not receive necessary approvals to commercialize our medicines in any other foreign market.

Although we have received marketing authorization for PYRUKYND® for the treatment of adults with PK deficiency in the EU and Great Britain and for PYRUKYND® for the treatment of adult patients with non-transfusion dependent and transfusion-dependent alpha- or beta-thalassemia in the EU, Saudi Arabia and the United Arab Emirates, we may not be able to file for additional marketing approvals and may not receive necessary approvals to commercialize our medicines in any other foreign market.

In addition, foreign regulatory authorities may change their approval policies and new regulations may be enacted.

For instance, in December 2025, the European Parliament and European Council reached a provisional political agreement on the revision of

EU pharmaceutical legislation, which is expected to be adopted by mid-2026.

EU pharmaceutical legislation, which is expected to be adopted by late-2026.

If the legislation is finalized in line with the provisional political agreement, it will have a significant impact on the EU pharmaceutical industry, which could impact our business.

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PYRUKYND®, AQVESME™ or any product candidate that we commercialize may become subject to unfavorable pricing regulations and third-party reimbursement practices, which would harm our business.

We built our commercial infrastructure to support the commercialization of PYRUKYND® in adult PK deficiency in the United States, and have expanded this infrastructure to support the commercial launch of AQVESME™ for the treatment of anemia in adults with non-transfusion dependent and transfusion-dependent alpha- or beta-thalassemia in the United States.

The commercial success of PYRUKYND®, AQVESME™ or of any of our product candidates will depend substantially, both domestically and abroad, on the extent to which the costs of our product candidates will be paid by third-party payors, including government health administration authorities and private health coverage insurers.

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Cost-control initiatives could cause us, or any collaborators, to decrease the price we, or they, might establish for products, which could result in lower than anticipated product revenue.

If the prices for our products decrease or if governmental and other third-party payors do not provide coverage or adequate reimbursement, our prospects for revenue and profitability will suffer.

If the prices for

our products decrease or if governmental and other third-party payors do not provide coverage or adequate reimbursement, our prospects for revenue and profitability will suffer.

In addition, increasingly, third-party payors are requiring higher levels of evidence of the benefits and clinical outcomes of new technologies and are challenging the prices charged.

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Since enactment of the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act, or collectively, the ACA, there have been, and continue to be, numerous legal challenges and Congressional actions to repeal and replace provisions of the law.

President Trump recently revoked numerous executive orders issued by President Biden, including at least two executive orders which where were designed to further implement the ACA.

President Trump recently revoked numerous executive orders issued by President Biden, including at least two executive orders which were designed to further implement the ACA.

Litigation and legislation over the ACA are likely to continue, with unpredictable and uncertain results.

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Subsequently, HHS indicated that the proposed MFN pricing will apply only to brand products without generic or biosimilar competition and the referenced foreign countries will include only those in which the branded product similarly does not have generic or biosimilar competition.

HHS also indicated that the MFN target price will be the lowest price in a country that is a

member of the Organization for Economic Co-operation and Development, or OECD, with a gross domestic product per capita of at least 60% of the U.S.

HHS also indicated that the MFN target price will be the lowest price in a country that is a member of the Organization for Economic Co-operation and Development, or OECD, with a gross domestic product per capita of at least 60% of the U.S.

gross domestic product per capita.

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If any subpoenas, investigations, or other enforcement actions are launched, or governmental or other sanctions are imposed, or if we do not prevail in any possible civil or criminal litigation, our business, results of operations and financial condition could be materially harmed.

In addition, responding to any action will likely result in a materially significant diversion of management’s attention and resources and significant defense and compliance costs and other professional fees.

In addition, responding to any action will likely result in a materially significant diversion of management’s attention and resources and significant defense and

compliance costs and other professional fees.

In certain cases, enforcement authorities may even cause us to appoint an independent compliance monitor which can result in added costs and administrative burdens.

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At the same time, however, the Trump Administration imposed a new 10% global tariff under Section 122 of the Trade Act of 1974, effective February 24, 2026.

Pursuant to the statute, absent an extension by Congress, these tariffs will expire in 150 days on July 24, 2026.

For those countries that have concluded trade deals with the United States, the tariff rates agreed to, including with regard to pharmaceuticals and pharmaceutical ingredients, have now reverted to 10% until July 24, 2026.

Like the IEEPA tariffs, pharmaceuticals and pharmaceutical ingredients are exempt from the Section 122 tariffs along with a list of other products.

The Trump Administration has announced that it also plans to initiate new investigations on “most major trading partners” under Section 301 of the same act, which will likely lead to additional tariffs.

Pursuant to the statute, these tariffs expired on July 24, 2026.

However, on July 23, 2026, the Office of the U.S.

Trade Representative announced final action under Section 301 of the Trade Act of 1974 imposing new tariffs on imports from 60 trading partners based on findings that those countries had failed to adopt and effectively enforce prohibitions on imports of goods produced with forced labor.

The new tariffs, set at either 10% or 12.5% depending on the country’s level of commitment to forced-labor import restrictions, took effect on July 24, 2026, and replaced the tariffs that had been imposed under Section 122.

The Trump Administration has announced that it also plans to initiate new investigations related to excess capacity on “most major trading partners” under Section 301 of the same act, which will likely lead to additional tariffs.

Sustained uncertainty about, or the further escalation of, trade and political tensions between the United States and China could result in a disadvantageous research and manufacturing environment in China, particularly for U.S.

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Our executive officers, directors and principal stockholders maintain the ability to significantly influence all matters submitted to stockholders for approval.

As of March 31, 2026, our executive officers, directors and principal stockholders, in the aggregate, beneficially owned shares representing a significant percentage of our capital stock.

As of June 30, 2026, our executive officers, directors and principal stockholders, in the aggregate, beneficially owned shares representing a significant percentage of our capital stock.

As a result, if these stockholders were to choose to act together, they would be able to significantly influence all matters submitted to our stockholders for approval, as well as our management and affairs.

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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 1A. Risk Factors