What changed in this filing

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Item 1. Legal Proceedings

2026-08-12 compared with 2026-05-07 · 81 added, 38 removed, 1219 unchanged (9% of the section changed)

19 unchanged sentences

We cannot give any assurance that any of our product candidates will receive regulatory approval, which is necessary before they can be commercialized.

• We may encounter substantial delays in our clinical trials or may not be able to conduct or complete our clinical trials on the timelines we expect.

• We conduct, and in the future plan to conduct, clinical trials for product candidates outside the United States, and the Food and Drug Administration, or FDA, and comparable foreign regulatory authorities may not accept data from such trials.

• We may encounter substantial delays in our clinical trials or may not be able to conduct or complete our clinical trials on the timelines we expect, if at all.

• Adverse events or undesirable side effects caused by, or other unexpected properties of, any of our product candidates could halt their clinical development, delay or prevent their regulatory approval, limit their commercial potential or result in significant negative consequences.

• We rely on third-party suppliers to manufacture our product candidates, and we intend to rely on third parties to produce commercial supplies of any approved product.

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• Our stock price has been volatile, and could in the future be volatile, and you may not be able to resell shares of our common stock at or above the price you paid.

• Actual or perceived failure to comply with applicable data protection laws, regulations, standards, contractual obligations and other requirements related to data privacy and security could lead to government enforcement actions as well as civil and criminal penalties, private litigation (including class actions), or adverse publicity and otherwise could negatively affect our results of operations and business.

• Actual or perceived failure to comply with applicable data protection laws, regulations, standards, contractual obligations and other requirements related to data privacy and security could lead to government enforcement actions as well as civil and criminal penalties, private litigation (including class actions), adverse publicity and otherwise could negatively affect our results of operations and business.

Risks Related to Our Limited Operating History, Financial Condition and Capital Requirements

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We have had significant operating losses since our inception.

Our net loss for the years ended December 31, 2025 and 2024 was approximately $206.7 million and $138.2 million, respectively, and our net loss for the three months ended March 31, 2026 was approximately $44.1 million.

As of March 31, 2026, we had an accumulated deficit of $961.5 million.

Our net loss for the years ended December 31, 2025 and 2024 was approximately $206.7 million and $138.2 million, respectively, and our net loss for the three and six months ended June 30, 2026 was approximately $55.3 million and $99.5 million, respectively.

As of June 30, 2026, we had an accumulated deficit of approximately $1.0 billion.

Substantially all of our losses have resulted from expenses incurred in connection with our research and development programs and from general and administrative costs associated with our operations.

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Because the outcome of any preclinical study or clinical trial is highly uncertain, we cannot reasonably estimate the actual amounts necessary to successfully complete the development and commercialization of our product candidates or any future product candidates.

As of March 31, 2026, we had capital resources consisting of cash and cash equivalents and short-term investments of approximately $225.0 million.

We expect our existing capital resources to fund planned operating expenses into the second half of 2027.

As of June 30, 2026, we had capital resources consisting of cash and cash equivalents and short-term investments of approximately $209.2 million.

We expect our existing capital resources to fund planned operating expenses into 2028.

However, our operating plans may change as a result of many factors currently unknown to us, and we may need to seek additional funds sooner than planned through public or private equity offerings or debt financings or other sources, such as strategic collaborations.

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Additional funds may not be available when we need them, on terms that are acceptable to us, or at all.

Our ability to raise additional capital may be adversely impacted by potential worsening global economic conditions, macroeconomic factors, including recent and potential bank failures, increasing inflation and interest rates, funding shortages at governmental and regulatory agencies on which we rely, exchange rate fluctuations and supply chain disruptions, geopolitical conflicts, such as the war in Ukraine and hostilities in the Middle East, and disruptions to and volatility in the credit and financial markets in the United States and worldwide.

Our ability to raise additional capital may be adversely impacted by potential worsening global economic conditions, macroeconomic factors, including recent and potential bank failures, increasing inflation and interest rates, funding shortages at governmental and regulatory agencies on which we rely, exchange rate fluctuations and supply chain disruptions, geopolitical conflicts, such as the war in Ukraine and conflicts in the Middle East, and disruptions to and volatility in the credit and financial markets in the United States and worldwide.

If adequate funds are not available to us on a timely basis, we may be required to:

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to involve restrictive covenants limiting our flexibility in conducting future business activities, and, in the event of insolvency, debt holders would be repaid before holders of our equity securities received any distribution of our corporate assets.

Our debt obligations under the Loan and Security Agreement place restrictions on our operating and financial flexibility and could adversely affect our financial condition.

On July 30, 2026, we entered into a Loan and Security Agreement, or Loan Agreement, with Oxford Finance LLC, as collateral agent, or Collateral Agent, and certain lenders from time to time party thereto, or Lenders, providing for term loans in an aggregate principal amount of up to $200.0 million, or Term Loans.

Under the terms of the Loan Agreement, the Lenders made an initial term loan of $50.0 million funded on the effective date of the Loan Agreement.

Three additional tranches in an aggregate principal amount of up to $100.0 million are available upon the achievement of specified milestones and conditions related to our vonaprument and tanruprubart registrational programs, and one additional uncommitted tranche in an aggregate principal amount of up to $50.0 million is available upon the mutual agreement of the Company and the Lenders.

The Term Loans bear interest at a floating per annum rate equal to the greater of (i) the 1-Month CME Term SOFR plus 4.6% and (ii) 7.60%.

The Term Loans mature on July 1, 2031, or June 1, 2032, depending on the achievement of certain milestones.

We are required to make monthly payments of interest only until September 1, 2029, which can be extended to September 1, 2030 or September 1, 2031, depending on the achievement of certain milestones, after which monthly payments of both principal and interest will be due.

The Term Loans may be prepaid, in whole or in part, at our option, subject to customary prepayment fees.

We are also obligated to pay other customary fees for a loan facility of this size and type, including a final payment fee upon repayment of the Term Loans (whether at maturity, upon acceleration or by prepayment or otherwise).

We granted the Collateral Agent a security interest in substantially all of our assets to secure our obligations under the Loan Agreement.

Our debt obligations under the Loan Agreement could adversely impact us as follows:

• require us to use a large portion of our cash flow to repay the outstanding principal balance, accrued and unpaid interest, prepayment fees, a final payment fee and other fees, if applicable, which will reduce the amount of cash flow available to fund working capital, capital expenditures, product candidate development and other general corporate purposes;

• adversely impact our credit rating, which could increase borrowing costs and reduce our ability to raise funds on favorable terms;

• subject us to restrictive covenants, including financial covenants that require us to maintain certain liquidity levels and/or minimum revenue levels upon the occurrence of certain events, that may limit our future ability to take certain corporate actions, incur additional indebtedness, create liens, make investments or pay dividends or distributions, or to raise funds for capital expenditures, strategic acquisitions or business opportunities, R&D, and other general corporate requirements;

• increase our vulnerability to adverse economic, industry and market conditions;

• increase our exposure to rising interest rates from variable rate indebtedness.

Our ability to meet our payment obligations under the Loan Agreement depends on our ability to generate significant cash flows or obtain external financing in the future.

This, to some extent, is subject to market, economic, financial, competitive, legislative, and regulatory factors as well as other factors that are beyond our control.

There can be no assurance that our business will generate cash flow from operations, or that additional capital will be available to us, in amounts sufficient to enable us to meet our debt payment obligations and to fund other liquidity needs.

Additionally, events and circumstances may occur which would cause us to not be able to satisfy applicable draw-down conditions and access the additional loan amounts available under the Loan Agreement.

If we are unable to generate sufficient cash flows to service our payment obligations or satisfy our covenants under the Loan Agreement, we may need to refinance, restructure, or amend the terms of our debt, sell assets, reduce or delay capital investments, or seek to raise additional capital.

If we are unable to implement one or more of these alternatives, we may be unable to meet our debt payment obligations which could result in an event of default.

If we default under the Loan Agreement, the Lenders may accelerate all of our repayment obligations and exercise all of their rights and remedies under the Loan Agreement and applicable law, including foreclosing on substantially all of our assets, which secure our obligations under the Loan Agreement, potentially requiring us to renegotiate the terms of our indebtedness on terms less favorable to us.

Further, if we are liquidated, the Lenders' right to repayment would be senior to the rights of the holders of our common stock to receive any proceeds from the liquidation.

The Loan Agreement includes events of default, including, but not limited to, nonpayment of principal, interest, fees or other amounts;

material inaccuracy of a representation or warranty;

failure to perform or observe covenants;

cross-defaults with certain other indebtedness;

bankruptcy and insolvency events;

material monetary judgment defaults;

the occurrence of a material adverse change;

impairment of the Lenders' security interest in the collateral;

and delisting of our common stock.

Upon the occurrence of an event of default (subject, in certain cases, to notice and grace periods), obligations under the Loan Agreement may be accelerated, thereby requiring us to repay the loans immediately.

Any declaration by the Lenders of an event of default could significantly harm our business and prospects and could cause the price of our common stock to

Additionally, if we raise any additional debt financing, the terms of such additional debt could further restrict our operating and financial flexibility.

Due to the significant resources required for the development of our product candidates, we must prioritize development of certain product candidates and/or certain disease indications.

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The currently ongoing open-label FORWARD study in the U.S.

and Europe, which is designed to broaden Western experience with tanruprubart, and we anticipate initial PK, PD, biomarker and functional data in 2026 to supplement our comprehensive data package for tanruprubart in GBS.

and Europe, which is designed to broaden Western experience with tanruprubart, and we anticipate initial PK, PD, biomarker and functional data in the second half of 2026 to supplement our comprehensive data package for tanruprubart in GBS.

Following such data, we plan to engage with the FDA with the goal of reaching alignment on the sufficiency of our current and supplemental data package and information supporting the generalizability of tanruprubart in Western patients for submission of a BLA in 2026.

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Following such data, we plan to engage with the FDA with the goal of reaching alignment on our current and supplemental data package and information supporting the generalizability of tanruprubart in Western patients for submission of a BLA in 2026.

In our discussion with the FDA, the FDA has indicated that the generalizability package may not be sufficient to support BLA approval absent additional patient data.

In our discussions with the FDA, the FDA has indicated that the generalizability package may not be sufficient to support BLA approval absent additional patient data.

While we expect that the inclusion of U.S.

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For example, with respect to vonaprument, there are two approved products for GA which may pose competition for vonaprument, if approved.

For additional information regarding our competition, see the section titled “Business—Competition”.

For additional information regarding our competition, see the section titled “Business—Competition” in our Annual Report on Form 10-K for the year ended December 31, 2025.

The successful commercialization of our product candidates will depend in part on the extent to which governmental authorities and health insurers establish adequate coverage, reimbursement levels and pricing policies.

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Even if we obtain coverage for our product candidates by a third-party payor, the resulting reimbursement payment rates may not be adequate or may require co-payments that patients find unacceptably high.

For products administered under the supervision of a physician, obtaining coverage and adequate reimbursement may be particularly difficult because of the higher prices often associated with such drugs.

Additionally, separate reimbursement for the product itself or the treatment or procedure in which the product is used may not be available, which may impact physician utilization.

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For example, the U.S.

Department of Health and Human

Services, or HHS, imposes rebates on many Medicare Part B and Medicare Part D products to penalize price increases that outpace inflation on an annual basis.

Department of Health and Human Services, or HHS, imposes rebates on many Medicare Part B and Medicare Part D products to penalize price increases that outpace

In addition, HHS has been empowered to negotiate the price of certain single-source drugs that have been on the market for at least 7 years and single-source biologics that have been on the market for at least 11 years covered under Medicare as part of the Medicare Drug Price Negotiation Program.

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If we are unable to enter into such arrangements on acceptable terms or at all, we may not be able to successfully commercialize our product candidates.

If we are not successful in commercializing our product candidates or any future product

candidates, either on our own or through arrangements with one or more third parties, we may not be able to generate any future product revenue and we would incur significant additional losses.

If we are not successful in commercializing our product candidates or any future product candidates, either on our own or through arrangements with one or more third parties, we may not be able to generate any future product revenue and we would incur significant additional losses.

We will need to increase the size of our organization, and we may experience difficulties in managing growth.

As of March 31, 2026, we had 93 full-time employees.

As of June 30, 2026, we had 92 full-time employees.

We will need to continue to expand our managerial, operational, finance and other resources in order to manage our operations and clinical trials, continue our development activities and commercialize our product candidates or any future product candidates.

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We do not carry earthquake insurance.

Earthquakes, wildfires or other natural disasters could

severely disrupt our operations, and could materially and adversely affect our business, financial condition, results of operations and prospects.

Earthquakes, wildfires or other natural disasters could severely disrupt our operations, and could materially and adversely affect our business, financial condition, results of operations and prospects.

If a natural disaster, power outage or other event occurred that prevented us from using all or a significant portion of our headquarters, that damaged critical infrastructure or that otherwise disrupted operations, it may be difficult or, in certain cases, impossible, for us to continue our business for a substantial period of time.

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Compliance with applicable environmental laws and regulations may be expensive, and current or future environmental laws and regulations may impair our research, product development and manufacturing efforts.

In addition, we cannot entirely eliminate the risk of accidental injury or contamination from hazardous materials or wastes.

In addition, we cannot entirely eliminate the risk

of accidental injury or contamination from hazardous materials or wastes.

Although we maintain workers’ compensation insurance to cover us for costs and expenses we may incur due to injuries to our employees resulting from the use of hazardous materials, this insurance may not provide adequate coverage against potential liabilities.

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Thus, we cannot guarantee that our activities related to their product candidates, or our commercialization, do not and will not infringe any third party’s intellectual property.

In addition, patent applications in the United States and many other jurisdictions are typically not published until 18 months after the filing of certain priority documents (or, in some cases, are not published until they issue as patents), and publications in the scientific literature often lag behind actual discoveries.

literature often lag behind actual discoveries.

Therefore, we cannot be certain that others have not filed patent applications or made public disclosures relating to our technology or our contemplated technology.

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Individual states in the United States have also become increasingly active in passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.

For example, on June 15, 2026, the FDA approved Colorado’s Section 804 Importation Program, or SIP, proposal to import certain drugs from Canada for specific state healthcare programs.

It is unclear how this and Florida’s similar program, approved by the FDA in 2024, will be implemented and whether they will overcome potential legal, regulatory, or industry challenges in the United States and/or Canada.

Legally mandated price controls on payment amounts by third-party payors or other restrictions could materially and adversely affect our business, financial condition, results of operations and prospects.

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Under the Drug Price Competition and Patent Term Restoration Act of 1984, or the Hatch-Waxman Act, a pharmaceutical manufacturer may submit an abbreviated new drug application, or ANDA, seeking approval of a generic version of an approved, small molecule innovator product.

Under the Hatch-Waxman Act, a manufacturer may also submit an NDA under section 505(b)(2) of the

Federal Food, Drug, and Cosmetic Act that references the FDA’s prior findings of safety and effectiveness of the small molecule innovator product.

Under the Hatch-Waxman Act, a manufacturer may also submit an NDA under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act that references the FDA’s prior findings of safety and effectiveness of the small molecule innovator product.

For example, a 505(b)(2) NDA product may be for a new or improved version of the original innovator product.

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federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act;

• the Health Insurance Portability and Accountability Act of 1996, which imposes criminal and civil liability for, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, or knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement, in connection with the delivery of, or payment for, healthcare benefits, items or services;

in connection with the delivery of, or payment for, healthcare benefits, items or services;

similar to the U.S.

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These broad market fluctuations may adversely affect the stock price or liquidity of our common stock.

We are a “smaller reporting company,” and as a result of the reduced disclosure and governance requirements applicable to smaller reporting companies, our common stock may be less attractive to investors.

We are a smaller reporting company and are therefore entitled to take advantage of many of the same exemptions from disclosure requirements as an emerging growth company, including reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements.

In addition, as a smaller reporting company with less than $100 million in annual revenue, we are exempt from the requirement to obtain an auditor attestation on the effectiveness of our internal control over financial reporting provided in Section 404(b) of the Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act.

These exemptions and reduced disclosures in our SEC filings due to our status as a smaller reporting company may make it harder for investors to analyze our results of operations and financial prospects.

We will cease to be eligible to use the requirements for smaller reporting companies beginning with the Quarterly Report on Form 10-Q for the fiscal quarter ending March 31, 2027.

Since we will no longer be a smaller reporting company and no longer qualify for applicable exemptions, we will be subject to additional laws and regulations affecting public companies that may increase our costs and the demands on management and could harm our operating results.

We are subject to the reporting requirements of the Exchange Act, which requires, among other things, that we file with the SEC, annual, quarterly and current reports with respect to our business and financial condition as well as other disclosure and corporate governance requirements.

As a “smaller reporting company”, we take advantage of certain exemptions from disclosure requirements including not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act and reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements.

Once we are no longer a smaller reporting company or otherwise qualify for these exemptions, we will be required to comply with these additional legal and regulatory requirements applicable to public companies and will incur significant legal, accounting and other expenses to do so.

If we are not able to comply with the requirements in a timely manner or at all, our financial condition or the market price of our common stock may be harmed.

For example, if we or our independent auditor identify deficiencies in our internal control over financial reporting that are deemed to be material weaknesses we could face additional costs to remedy those deficiencies, the market price of our stock could decline or we could be subject to sanctions or investigations by the SEC or other regulatory authorities, which would require additional financial and management resources.

Because the aggregate market value of our common stock held by non-affiliates exceeded $700 million as of June 30, 2026, we will be ineligible to use the requirements for smaller reporting companies beginning with our Quarterly report on Form 10-Q for the quarter ending March 31, 2027, but will remain a non-accelerated filer through 2027.

When we are no longer a “non-accelerated filer”, we will have to provide more expansive disclosure regarding executive compensation in our periodic reports and be subject to shorter filing deadlines, which will require additional time and expense.

We will also be required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act.

We incur significant costs as a result of operating as a public company, and our management needs to devote substantial time to compliance initiatives.

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Moreover, these reporting requirements, rules and regulations increase our legal and financial compliance costs and make some activities more time-consuming and costly.

retain qualified persons to serve on our board of directors or board committees or to serve as executive officers, or to obtain certain types of insurance, including directors’ and officers’ insurance, on acceptable terms.

These reporting requirements, rules and regulations, coupled with the increase in potential litigation exposure associated with being a public company, could also make it more difficult for us to attract and retain qualified persons to serve on our board of directors or board committees or to serve as executive officers, or to obtain certain types of insurance, including directors’ and officers’ insurance, on acceptable terms.

If we experience material weaknesses in the future or otherwise fail to maintain an effective system of internal controls in the future, we may not be able to accurately report our financial condition or results of operations which may adversely affect investor confidence in us and, as a result, the value of our common stock.

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Our principal stockholders and management own a significant percentage of our stock and will be able to exert significant control over matters subject to stockholder approval.

As of March 31, 2026, our executive officers, directors, holders of 5% or more of our capital stock and their respective affiliates beneficially owned 41% of our outstanding voting stock.

As of June 30, 2026, our executive officers, directors, holders of 5% or more of our capital stock and their respective affiliates beneficially owned 47% of our outstanding voting stock.

In addition, in our 2023, 2024, and 2025, financings, certain of the holders of 5% or more of our capital stock acquired pre-funded warrants to purchase shares of our common stock (which are immediately exercisable and have an exercise price of $0.001 per share) or common warrants to purchase shares of our common stock.

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For example, these stockholders may be able to control elections of directors, amendments of our organizational documents, or approval of any merger, sale of assets or other major corporate transaction.

prevent or discourage unsolicited acquisition proposals or offers for our common stock that you may feel are in your best interest as one of our stockholders.

Our current shares outstanding and resulting market valuation do not reflect shares of our common stock issuable upon the exercise of pre-funded warrants and common warrants that are exercisable at the discretion of the holders of such warrants.

This may prevent or discourage unsolicited acquisition proposals or offers for our common stock that you may feel are in your best interest as one of our stockholders.

Our current shares outstanding and resulting market valuation do not reflect shares of our common stock issuable upon the exercise of pre-funded warrants that are exercisable at the discretion of the holders of such warrants.

If we sell shares of our common stock in the future, stockholders may experience immediate dilution.

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In March 2026, we entered into a new sales agreement with TD Cowen, as sales agent, pursuant to which we may issue and sell shares of our common stock for an aggregate maximum offering price of up to $150 million under a new at-the-market offering program.

In addition, in December 2023, June 2024, and November 2025, we closed financings which included the sale of pre-funded warrants or common warrants to purchase shares of our common stock.

Until exercised, the shares issuable upon the exercise of the pre-funded warrants or the common warrants are not included in the number of our outstanding shares of common stock.

As of the filing date of this Quarterly Report on Form 10-Q, we had sold $32.2 million of common stock under the program.

In addition, in December 2023, June 2024, and November 2025, we closed financings which included the sale of pre-funded warrants to purchase shares of our common stock.

Until exercised, the shares issuable upon the exercise of the pre-funded warrants are not included in the number of our outstanding shares of common stock.

If we issue common stock or securities convertible into common stock in the future, our stockholders would experience additional dilution and such dilutive impact may be difficult to compute.

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If our existing stockholders sell, or indicate an intention to sell, substantial amounts of our common stock in the public market, the stock price of our common stock could decline.

As of March 31, 2026, the number of shares of our common stock outstanding was 162,501,717.

This number does not include 35,765,799 shares of common stock issuable upon the exercise of pre-funded warrants or 6,877,622 shares of common stock issuable upon the exercise of common warrants.

As of June 30, 2026, the number of shares of our common stock outstanding was 174,604,198.

This number does not include 29,765,799 shares of common stock issuable upon the exercise of pre-funded warrants.

On August 12, 2024, we filed a resale registration statement on Form S-3, pursuant to which, entities and trusts affiliated with Muneer Satter, a member of our board of directors, can sell up to 3,000,000 shares of common stock.

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Our ability to use NOLs, research and development credit carryforwards and other tax attributes to reduce future taxable income and tax liabilities may be further limited as a result of shifts in our stock ownership subsequent to December 31, 2025.

As a result, even if we attain profitability, our ability to use our pre-change NOLs or other pre-change tax attributes to offset United States federal and state taxable income may be subject to further limitations.

As a result, even

if we attain profitability, our ability to use our pre-change NOLs or other pre-change tax attributes to offset United States federal and state taxable income may be subject to further limitations.

Provisions in our charter documents and under Delaware law could discourage a takeover that stockholders may consider favorable and may lead to entrenchment of management.

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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 1. Legal Proceedings