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OMER 10-K & 10-Q changes, risk factors and insider trading

Omeros Corp. · Nasdaq · Pharmaceutical Preparations · CIK 1285819 · All filings on SEC.gov

Everything below is quoted or computed from Omeros Corp.'s public SEC filings. It is not a recommendation to buy or sell. Automated comparisons can contain errors; confirm with the original filing.

At a glance

37 / 25risk-factor paragraphs added / removed in latest 10-K
11new risk-factor headings
0Form 4 filings reporting open-market purchases (last 180 days)
7Form 4 filings reporting open-market sales (last 180 days)

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What changed in the latest 10-K

Comparing 10-K filed 2026-03-31 (period ending 2025-12-31) with 10-K filed 2025-03-31 (period ending 2024-12-31).

Risk Factors (10-K Item 1A)

37new paragraphs
25removed paragraphs
36reworded paragraphs
12,038 → 12,098words in section

New heading “Our ability to achieve profitability is highly dependent on the commercial success of YARTEMLEA, and to the extent YARTEMLEA is not successful, our business, financial condition and results of operations may be materially adversely affected and the price of our common stock may decline.”

New heading “If YARTEMLEA or any other product that we develop and commercialize does not receive adequate coverage or reimbursement from governments and/or private payers our prospects for revenue and profitability would suffer.”

New heading “Our ability to realize further value from zaltenibart depends on the development and commercialization efforts of Novo Nordisk.”

New heading “We may face a variety of risks associated with international operations that, if realized, could materially adversely affect our business.”

New heading “Failure to comply with any YARTEMLEA post-marketing requirement or commitment could materially adversely affect the commercial prospects of YARTEMLEA and our business.”

New heading “We have no internal capacity to manufacture commercial or clinical supplies of YARTEMLEA or our product candidates, intend to continue to rely solely on third-party manufacturers, and thus may be materially harmed by issues impacting our contract manufacturers or our relationship with our contract manufacturers.”

New heading “Our obligations under the Transition Services Agreement require us to utilize significant internal resources that could otherwise be used to advance our other programs.”

New heading “Novo Nordisk controls significant aspects of the prosecution, maintenance, and enforcement of key intellectual property covering zaltenibart products, and its failure to protect, enforce, or maintain that intellectual property could adversely affect the commercial value of zaltenibart products and, in turn, the milestone or royalty payments we receive.”

New heading “Our use of artificial intelligence exposes us to deficient outputs, unintentional disclosures, and an evolving regulatory landscape.”

New heading “The availability of royalties from Rayner is dependent on Rayner’s net sales of OMIDRIA and may be of lesser magnitude than anticipated or may not become payable at all and we do not expect to receive a sales-based milestone payment from DRI.”

New heading “Our ability to use our net operating loss carryforwards and certain other tax attributes to offset taxable income or taxes may be limited.”

Removed heading “Management has concluded that a substantial doubt is deemed to exist concerning our ability to continue as a going concern.”

Removed heading “Our Credit Agreement places restrictions on our operating and financial flexibility and could, if we were to default, adversely affect our liquidity and ability to retain title to our assets.”

Removed heading “If any product that we develop and commercialize does not receive adequate coverage or reimbursement from governments and/or private payers our prospects for revenue and profitability would suffer.”

Removed heading “Our ability to meet our future capital requirements is partially dependent on certain milestone and royalty payments that we are eligible to receive based on Rayner’s sales of OMIDRIA, and, if sales of OMIDRIA are less than anticipated and/or Rayner is unable to expand sales of OMIDRIA outside the U.S., our financial condition and results of operations may be materially adversely affected, the price of our common stock may decline and we may be unable to access needed capital on favorable terms, or at all.”

Largest changes (selected automatically by length and topic keywords; quoted verbatim, no commentary)

Removed text topics: bankruptcy, default, litigation, liquidity
“We have borrowed approximately $67.1 million under the Credit Agreement and pledged substantially all of our assets, including our intellectual property, as collateral. …”
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Removed text topics: default, liquidity
“Our Credit Agreement places restrictions on our operating and financial flexibility and could, if we were to default, adversely affect our liquidity and ability to retain title to our assets.”
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Removed text topics: going concern
“Management has concluded that a substantial doubt is deemed to exist concerning our ability to continue as a going concern.”
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Removed text topics: going concern, covenant
“As further discussed in Part II, Item 8, “Note 1—Organization and Basis of Presentation” to our Consolidated Financial Statements in this Annual Report on Form 10-K, substantial doubt exists regarding our ability to continue as a going concern through one year from the issuance of the Company's consolidated financial statements included in this Annual Report on Form 10-K. …”
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Reworded topics: tariff, china, labor

Paragraph as it now reads, with added and removed wording marked:

In addition, recent policy actions by the new U.S. administration, including thebroad imposition of new tariffs on imported materials and goods from certain foreign countries, including Canada, Mexico and China, and the temporary freeze on federal grants and loans,tariffs, may have an adverse impact on our business. Increased tariffs on critical raw materials, components, and finished goods could raise our production costs, disrupt our supply chain, and reduce our competitiveness in the marketplace. Additionally, the administration's halt on certain federal research grants may negatively impact our industry. Any prolonged reductions in such funding could slow innovation, delay collaborations, and limit the adoption of new technologies that contribute to our business growth. If these or similarother policy changes continue or expand, we may face increased costs. Although we cannot predict the full extent of these impacts, any prolonged disruption could adversely affect our business, financial condition, and results of operations.
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New text topics: artificial intelligence
“Our use of artificial intelligence exposes us to deficient outputs, unintentional disclosures, and an evolving regulatory landscape.”
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Full comparison: every changed paragraph (98)

Green = added, red = removed. Unchanged paragraphs, 1 paragraphs where only numbers/dates changed, and tables are not shown. Read the complete text in the original filing.

Reworded

Risks Related to Our Products, Product Candidates, Programs and Operations

Added

Our ability to achieve profitability is highly dependent on the commercial success of YARTEMLEA, and to the extent YARTEMLEA is not successful, our business, financial condition and results of operations may be materially adversely affected and the price of our common stock may decline.

Added

YARTEMLEA is our only commercialized product and was approved by FDA for commercial sale in the United States in December 2025. Our near‑term commercial prospects are highly dependent on YARTEMLEA in its approved indication, and any adverse developments affecting YARTEMLEA could have a disproportionate adverse effect on our business. We will need to generate substantial product revenue from YARTEMLEA to fund our operations fully and to achieve and sustain profitability. We may be unable to successfully commercialize YARTEMLEA for a number of reasons, including:

Added

If we are not able to successfully commercialize YARTEMLEA for these or other reasons, our ability to generate sufficient revenues from product sales to achieve profitability will be adversely affected and the market price of our common stock could decline significantly.

Added

If YARTEMLEA or any other product that we develop and commercialize does not receive adequate coverage or reimbursement from governments and/or private payers our prospects for revenue and profitability would suffer.

Added

The success of YARTEMLEA or any product that we or our third-party business partners commercialize in the future will depend heavily on the pricing, availability and duration of adequate coverage or reimbursement for any such product from government, private and other third-party payers, both in the U.S. and in other countries.

Added

Our ability to realize further value from zaltenibart depends on the development and commercialization efforts of Novo Nordisk.

Added

Our ability to realize further value from zaltenibart depends on Novo Nordisk’s successful development, regulatory approval, and commercialization of zaltenibart. As a result of our APLA with Novo Nordisk, Novo Nordisk now controls key decisions regarding the development, regulatory strategy, manufacturing, and commercialization of zaltenibart. This means that whether we receive payments potentially due to us under the terms of the APLA, and the magnitude of such payments, depends on Novo Nordisk’s ability to advance development and obtain regulatory approval of zaltenibart. Novo Nordisk may not successfully advance development, obtain regulatory approval or commercialize zaltenibart products for many reasons, including that it may determine not to pursue development in certain indications, may delay or discontinue development programs, or may prioritize other programs in its pipeline.

Added

In addition, the potential consideration we may yet receive under the APLA consists of development milestones, sales milestones, and royalties on net sales of products containing zaltenibart. These payments are contingent on factors outside of our control such as the successful development, regulatory approval, and commercialization of zaltenibart, any of which may never occur. If Novo Nordisk does not successfully develop or commercialize zaltenibart, or if commercialization is less successful than anticipated, we may receive substantially less in milestone and royalty payments than we currently expect or no additional payments at all. Further, even if products containing zaltenibart are successfully commercialized, the amount of royalty revenue we receive may vary significantly from period to period and may be affected by factors such as pricing, reimbursement, sales volumes, competition, and other market conditions. In sum, our ability to realize further value from this transaction could be materially adversely affected and, in turn, our future operating results and financial condition could be materially adversely affected.

Removed

Management has concluded that a substantial doubt is deemed to exist concerning our ability to continue as a going concern.

Removed

As further discussed in Part II, Item 8, “Note 1—Organization and Basis of Presentation” to our Consolidated Financial Statements in this Annual Report on Form 10-K, substantial doubt exists regarding our ability to continue as a going concern through one year from the issuance of the Company's consolidated financial statements included in this Annual Report on Form 10-K. Our financial statements do not include any adjustment relating to the recoverability and classification of assets or the amounts and classification of liabilities that might be necessary should we be unable to continue as a going concern. Our ability to continue as a going concern will require us to generate positive cash flow from operations, obtain additional financing, enter into strategic alliances and/or sell assets. Our limited cash resources, which are impacted by a covenant in the Credit Agreement requiring us to maintain $25.0 million of unrestricted cash, cash equivalents and short-term investments at all times, and our potential inability to continue as a going concern may materially adversely affect our share price and our ability to raise new capital, enter into strategic alliances and/or make our scheduled debt payments on a timely basis or at all. If we become unable to continue as a going concern, we may have to liquidate our assets and the values we receive for our assets in liquidation or dissolution could be significantly lower than the values reflected in our financial statements.

Reworded

We have incurred cumulative operating losses since inception. If we are unable to raise additional capital when neededneeded, we may be unable to complete the development and commercialization of our products and product candidates or to continue our other preclinical development programs.

Reworded

Our operations have consumed substantial amounts of cash since our incorporation, As of December 31, 2024,2025, we had cash, cash equivalents and short-term investments of $90.1$171.8 million. Our cash used in operations for the year ended December 31, 2025 was $148.8$116.1 million and our net loss for the year ended December 31, 20242025 was $156.8$3.4 million. Pursuant to a covenant in the Credit Agreement, we must maintain $25.0 million of unrestricted cash, cash equivalents and short-term investments at all times. We expect to continue to spend substantial amounts to:

Removed

● continue our research and development in our programs;

Removed

● make principal, interest and fee payments as required under our 2026 Notes;

Removed

● make interest payments under the initial term loan of $67.1 million provided pursuant to the Credit Agreement (the “Initial Term Loan”); and

Reworded

● commercialize YARTEMLEA and launchany other product candidates for which we may receive regulatory approval.approval in the future;

Added

● support YARTEMLEA sales and marketing;

Added

● continue our research and development programs; and

Added

● make principal, interest and fee payments as required under our convertible senior notes maturing on June 15, 2029 (the “2029 Notes”).

Reworded

We expect to continue to incur additional losses until such time as we generate significant revenue from the sale of YARTEMLEA or other commercial products or from our APLA with Novo Nordisk or other partnerships. We are unable to predict the extent of any future losses and cannot provide assurance that we will generate sufficient revenue from YARTEMLEA or commercial products in the future to fund our operations fully. If we are unable to generate sufficient revenue from YARTEMLEA or other commercialized products or partnership arrangements, we may never become and remain profitable and will be required to raise additional capital to continue to fund our operations. We cannot be certain that additional capital will be available to us on acceptable terms, if at all, when required. Adverse developments to our financial condition or business, as well as disruptions in the global equity and credit markets, may limit our ability to access capital. In addition, pursuing debt financings, certain equity offerings or other strategic transactions may result in mandatory prepayments of the Initial Term Loan. If we do not raise additional capital when needed through one or more funding avenues, such as debt or equity financings or corporate partnering, we may have to significantly delay, scale back or discontinue the development or commercialization of one or more of our product candidates or one or more of our preclinical programs or other research and development initiatives. In addition, we may be required to seek collaborators for one or more of our current or future products at an earlier stage than otherwise would be desirable or on terms that are less favorable than otherwise might be available or to relinquish or license on unfavorable terms our rights to technologies or products that we otherwise would seek to develop or commercialize ourselves. We also may have insufficient funds or otherwise be unable to advance our preclinical programs to a point where they can generate revenue through partnerships, collaborations or other arrangements. Any of these actions could limit the amount of revenue we are able to generate and harm our business and prospects.

Removed

Our Credit Agreement places restrictions on our operating and financial flexibility and could, if we were to default, adversely affect our liquidity and ability to retain title to our assets.

Removed

We have borrowed approximately $67.1 million under the Credit Agreement and pledged substantially all of our assets, including our intellectual property, as collateral. The Credit Agreement restricts or places conditions on, among other things, our ability to incur indebtedness, grant liens, dispose of assets, make investments, make acquisitions, enter into certain transactions with affiliates, pay cash dividends or make distributions, repurchase stock, repurchase our 2026 Notes, license certain of our intellectual property on an exclusive basis and engage in significant business transactions such as a change of control. Any of these restrictions could significantly limit our operating and financial flexibility and ability to respond to changes in our business or competitive activities. The failure to satisfy these or other obligations under the Credit Agreement could constitute an event of default, which could provide the lenders with a right to accelerate our repayment obligations under the Credit Agreement and to take control of our pledged assets, which includes substantially all of our intellectual property assets. Upon acceleration of the Credit Agreement, we would be required to repay outstanding amounts immediately or to attempt to reverse the declaration through negotiation or litigation. In addition, if an acceleration event were to occur under the Credit Agreement and not be cured, the trustee or the holders of the 2026 Notes would have the right to accelerate our repayment obligations for all principal and accrued and unpaid interest on the 2026 Notes then outstanding. If we are unable to repay amounts outstanding under the 2026 Notes and Credit Agreement, we could be forced into bankruptcy or liquidation and we would lose title to substantially all of our assets, including our intellectual property. In any related proceeding, the lenders’ right to repayment under the Credit Agreement would be senior to the right of repayment of the holders of the 2026 Notes and the rights of both would be senior to the rights of the holders of our common stock. Any event of default could accordingly have a material adverse effect on our operations, financial condition and liquidity, and could cause the price of our 2026 Notes and common stock to decline significantly.

Reworded

In addition to our Credit Agreement, our otherOur indebtedness and liabilities and any future indebtedness could limit the cash flow available for our operations and expose us to risks that could adversely affect our business, financial condition and results of operations.

Added

As of December 31, 2025, we had $17.1 million total aggregate principal amount outstanding of our 5.25% convertible senior notes due on February 15, 2026 (the “2026 Notes”), which have since matured and been repaid in full, $70.8 million total aggregate principal amount outstanding of our 2029 Notes, and approximately $1.2 million of outstanding finance lease obligations. We may incur additional indebtedness to meet future financing needs, which may have the effect of:

Removed

As of December 31, 2024, we had $97.2 million total aggregate principal amount of our 2026 Notes outstanding, $67.1 million total aggregate principal amount outstanding under the Initial Term Loan, and we had approximately $2.0 million of outstanding finance lease obligations. We may incur additional indebtedness to meet future financing needs. As described above, our Credit Agreement places restrictions on our operating and financial flexibility, and our other existing and future indebtedness could also have significant negative consequences for our security holders and our business, results of operations and financial condition by, among other things:

Reworded

● diluting the interests of our existing stockholders as a result of issuing shares of our common stock upon any conversion of the 20262029 Notes or additional convertible notes that we may issue in the future;

Reworded

Our ability to make scheduled payments of the principal of, to pay interest on, or to refinance our indebtedness depends on our future performance, which is subject to many factors, including economic, financial, competitive and other circumstances beyond our control. Our business may not generate sufficient funds, and we may otherwise be unable to maintain sufficient cash reserves, to pay amounts due under our indebtedness and our cash needs may increase in the future. In addition, future indebtedness that we may incur may contain financial and other restrictive covenants that further limit our ability to operate our business, raise capital or make payments under our other indebtedness. If we fail to comply with these covenants or to make payments under our indebtedness when due, then we would be in default under that indebtedness, which could, in turn, result in that and our other indebtedness becoming immediately payable in full.

Reworded

Failure to obtain and maintain regulatory approval in the U.S.EU or inother foreign jurisdictions would prevent us from commercializing and marketing ourYARTEMLEA productor candidates.future commercialized products.

Removed

The regulatory process is subject to substantial agency discretion and risks, including those described herein and elsewhere in these “Risk Factors.” In October 2021, we received a CRL from FDA regarding our BLA for narsoplimab for the treatment of TA-TMA. In the CRL, FDA expressed difficulty in estimating the treatment effect of narsoplimab in TA-TMA and asserted that additional information would be needed to support regulatory approval. We appealed FDA’s decision to issue the CRL through a formal dispute resolution process that concluded in late 2022. Although our appeal was denied, the decision identified a potential path for resubmission of the BLA based on inclusion of certain additional information and analyses. Based on the decision and on subsequent interactions with FDA, we proposed a statistical analysis plan to assess data from our pivotal clinical trial, existing data from an historical control population available from an external source and data from the narsoplimab expanded access program. The primary endpoint under the analysis plan is patient survival in our pivotal narsoplimab trial compared to that in an external registry of TA-TMA patients who were not treated with narsoplimab. Analyses similar to the primary analysis comparing survival in TA-TMA patients treated with narsoplimab under a global EAP to that of similarly at-risk TA-TMA registry patients were also included in the analysis plan, along with sensitivity analyses related to each of the primary and EAP comparisons. All statistical analyses were conducted by an independent statistical group. These data and analyses are included in our recently resubmitted BLA for narsoplimab in TA-TMA. We expect also to include these data and analyses in the MAA for narsoplimab in this indication.

Removed

We cannot guarantee when or if FDA or EMA will approve narsoplimab for the treatment of TA-TMA. Even if our clinical data, data from our EAP and statistical analyses comparing these data to an external registry of TA-TMA patients provide favorable evidence of the effectiveness of narsoplimab in the treatment of TA-TMA, the reviewing agency may determine that such evidence is insufficient to support regulatory approval for any reason, including unfavorable interpretation of our analysis results, potential differences between the diagnostic criteria used in our pivotal trial and in the external registry, a determination by the reviewing agency that the registry used in our statistical analysis is insufficiently representative of TA-TMA patients to provide a reliable control, FDA’s assessment of the comparability of the registry to the population in our pivotal trial, the sufficiency of our sensitivity analyses, and/or the lack of additional control sources. Additionally, we do not currently have narsoplimab manufacturing slots scheduled with our contract manufacturing partner and, if a pre-licensing inspection is requested in connection with agency review of our BLA or MAA, we may face difficulty in securing manufacturing capacity to support such inspection at reasonable cost, or at all, our manufacturing partner may also fail to provide other needed regulatory support on a timely basis, or at all. Any difficulties associated with our contract manufacturer’s support in connection with regulatory processes could prevent or delay review and approval of our marketing application. Overall, the requirements for resubmission of our BLA have been and may continue to be costly, require significant time and may not result in approval. Ultimately, we cannot guarantee that FDA or EMA will ever approve narsoplimab for the treatment of TA-TMA or any other indication.

Reworded

We also intend to market outsideYARTEMLEA the U.S.and any of our product candidates that are approved in the future.future outside the U.S. In order to market our products in non-U.S. jurisdictions, we or our partners must obtain separate regulatory approvals and comply with numerous and varying regulatory requirements. The regulatory approval procedure varies among countries and can involve additional testing and data review. The requirements governing marketing authorization, the conduct of clinical trials, pricing and reimbursement vary from country to country. Approval by FDA does not ensure approval by the EMA, and approval by one foreign regulatory authority does not ensure approval by regulatory agencies in other foreign countries or by FDA. The time required to obtain regulatory approval outside the U.S. and EU may differ from that required to obtain FDA or EU approval. The foreign regulatory approval process may include all of the risks associated with obtaining FDA approval discussed in these “Risk Factors” and weWe may not obtain foreign regulatory approvals on a timely basis, or at all. In addition, even if we were able to obtain regulatory approval for a product in one or more foreign jurisdictions, we may need to complete additional requirements to maintain that approval and our ability to market the product in the applicable jurisdiction.

Added

We may face a variety of risks associated with international operations that, if realized, could materially adversely affect our business.

Added

We may be subject to additional risks for YARTEMLEA or any of our product candidates that are marketed outside the U.S., including:

Added

Any of these risks, if realized, could increase our operating expenses and reduce our revenues.

Removed

If any product that we develop and commercialize does not receive adequate coverage or reimbursement from governments and/or private payers our prospects for revenue and profitability would suffer.

Removed

The success of any product that we or our third-party business partners commercialize in the future will depend heavily on the pricing, availability and duration of adequate coverage or reimbursement for any such product from government, private and other third-party payers, both in the U.S. and in other countries.

Removed

Our ability to meet our future capital requirements is partially dependent on certain milestone and royalty payments that we are eligible to receive based on Rayner’s sales of OMIDRIA, and, if sales of OMIDRIA are less than anticipated and/or Rayner is unable to expand sales of OMIDRIA outside the U.S., our financial condition and results of operations may be materially adversely affected, the price of our common stock may decline and we may be unable to access needed capital on favorable terms, or at all.

Removed

In February 2024, we sold to DRI an expanded interest in OMIDRIA royalties payable by Rayner. Pursuant to the Amendment with DRI, DRI is entitled to receive all royalties on U.S. net sales of OMIDRIA between January 1, 2024 and December 31, 2031. We retain the right to receive all royalties payable by Rayner on any net sales of OMIDRIA outside the U.S. as well as royalties on global net sales of OMIDRIA payable from and after December 31, 2031. We received $115.5 million upon closing of the Amendment. Additionally, we are eligible under the Amendment to receive two milestone payments of up to $27.5 million each, payable in January 2026 and January 2028, respectively, based on achievement of certain thresholds for U.S. net sales of OMIDRIA.

Removed

The royalty rate payable by Rayner on net sales of OMIDRIA is currently 30% in the United States and 15% outside the U.S. The royalty rate is subject to further reduction to 10% of U.S. net sales upon the occurrence of certain events, including during any specific period in which OMIDRIA is no longer eligible for separate payment. The availability of royalties from Rayner and/or milestone payments from DRI is dependent on Rayner’s net sales of OMIDRIA and may be of lesser magnitude than anticipated or may not become payable at all. We cannot provide assurance that royalty income from Rayner and/or milestone payments from DRI, if they become payable, will be a meaningful source of capital in the future. Sales-based royalty income and milestone payments may be affected by any number of factors, including:

Removed

● Rayner’s ability to successfully market and sell OMIDRIA in the U.S.;

Removed

● whether, and to what extent, Rayner is able to expand sales of OMIDRIA outside the U.S.;

Removed

● pricing, coverage and reimbursement policies of government and private payers such as Medicare, Medicaid, the U.S. Department of Veterans Affairs, group purchasing organizations, insurance companies, health maintenance organizations and other plan administrators;

Removed

● a lack of acceptance by physicians, patients and other members of the healthcare community;

Removed

● interruptions in the supply of OMIDRIA;

Removed

● the availability, relative price and efficacy of the product as compared to alternative treatment options or branded, compounded or generic competing products;

Removed

● an unknown safety risk; and

Removed

● changed or increased regulatory restrictions in the U.S., EU and/or other foreign territories.

Added

● the level and timing of commercial sales of YARTEMLEA, as well as our product candidates if and when approved or commercialized;

Added

● the availability and adequacy of payer reimbursement for YARTEMLEA;

Added

● the amount of YARTEMLEA chargebacks, rebates and product returns;

Added

● the extent and magnitude of certain milestone and royalty payments to which we may be entitled based on Novo Nordisk’s development, commercialization, and net sales of zaltenibart;

Reworded

● the extent and magnitude of certain payments to which we may be entitled based on Rayner’s net sales of OMIDRIA by Rayner Surgical, Inc. (“Rayner”) depend on Rayner’s ability to successfully market and sell OMIDRIA and may be affected by the extent of coverage and reimbursement for OMIDRIA, market acceptance of the product and Rayner’s ability to execute an effective sales strategy;

Reworded

● the timing, cost and level of investment in our research and development activities as well as expenditures we may incur to acquire or develop additional technologies, products and product candidates, or in preparation for potential commercialization of our product candidates; and

Reworded

Significant changes to the size, structure, powers and operations of the U.S. federal government, as well as recent policy actions by the U.S. federal government, may cause economic disruptions or changes in the regulatory environment that could, in turn, adversely impact our business, results of operations and financial conditions.condition.

Reworded

The newcurrent U.S. administration has begun to implementimplemented significant changes to the size and scope of the federal government to achieve stated goals including reducing the federal budget deficit and national debt, improving the efficiency of government operations, and promoting innovation and economic growth. To date, these efforts have been carried out through a mix of executive actions aimed at eliminating or modifying federal agency and federal program funding, reducing the size of the federal workforce, reducing or altering the scope of activities conducted by, and possibly eliminating, various federal agencies and bureaus. If implemented, theseThese changes may have varied effects on the economy that are difficult to predict. For instance, the delivery of government services and the distribution of federal program funds and benefits may be disrupted or, in some cases, eliminated as a result of funding cuts, recasting of federal agency mandates or a substantial reduction of the federal workforce. We rely on the availability, predictability and efficiency of federal agencies including FDA, NIDA and others in connection with the operation of our business and programs. Our business, financial condition and results of operations could be materially and adversely affected by disruptions affecting these or other agencies in areas relevant to our programs and operations.

Reworded

In addition, recent policy actions by the new U.S. administration, including thebroad imposition of new tariffs on imported materials and goods from certain foreign countries, including Canada, Mexico and China, and the temporary freeze on federal grants and loans,tariffs, may have an adverse impact on our business. Increased tariffs on critical raw materials, components, and finished goods could raise our production costs, disrupt our supply chain, and reduce our competitiveness in the marketplace. Additionally, the administration's halt on certain federal research grants may negatively impact our industry. Any prolonged reductions in such funding could slow innovation, delay collaborations, and limit the adoption of new technologies that contribute to our business growth. If these or similarother policy changes continue or expand, we may face increased costs. Although we cannot predict the full extent of these impacts, any prolonged disruption could adversely affect our business, financial condition, and results of operations.

Reworded

Obtaining FDA approval of our product candidates requires substantial time, effort and financial resources and may be subject to both expected and unforeseen delays, and there can be no assurance that any approval will be granted on any of our product candidates on a timely basis, if at all. As was the case with our BLA for narsoplimab in TA-TMA, with respect to which FDA issued a CRL, evenEven after collaborating closely with FDA or regulators with corollary responsibilities in jurisdictions outside the U.S. regarding the contents of a marketing application a regulator may decide that the design of our clinical trials or clinical data collection protocols as actually run, or our resulting data, are insufficient for approval of our product candidates. FDA or other regulators may require us to run additional preclinical, clinical or other studies or perform additional work related to chemistry, manufacturing and controls. In addition, we, FDA or an independent institutional review board or ethics committee may suspend or terminate human clinical trials at any time on various grounds, including a finding that the patients are or would be exposed to an unacceptable health risk or because of the way in which the investigators on whom we rely carry out the trials. We are subject to extensive government regulation of the testing of our investigational products, including the requirement that we conduct all of our clinical trials in accordance with FDA’s GCP requirements and similar requirements outside of the U.S. If we are unable to comply with these requirements, if we are required to conduct additional trials or to conduct other testing of our product candidates beyond that which we currently contemplate for regulatory approval, if we are unable to complete our clinical trials or other testing successfully, or if the results of these and other trials or tests fail to demonstrate efficacy or raise safety concerns, we may face substantial additional expenses, be delayed in obtaining marketing approval for our product candidates or may never obtain marketing approval.

Added

Failure to comply with any YARTEMLEA post-marketing requirement or commitment could materially adversely affect the commercial prospects of YARTEMLEA and our business.

Added

Following FDA approval of YARTEMLEA, we remain subject to ongoing regulatory oversight, including a post-marketing requirement and post-marketing commitments. These include, among other obligations, a post-marketing requirement safety registry and post-marketing commitments related to a pediatric PK/PD study and CMC. The associated timelines extend over multiple years.

Showing the first 60 of 98 changed paragraphs. The complete comparison will be part of Pro (coming soon). Meanwhile you can read the full text in the original filing.

Management's Discussion & Analysis (MD&A) (10-K Item 7)

78new paragraphs
29removed paragraphs
35reworded paragraphs
7,290 → 8,879words in section

New heading “Commercial Product – YARTEMLEA”

New heading “Debt Financing Transactions”

New heading “Exchange of 2026 Notes for Term Loan and Cash”

New heading “Exchange of 2026 Notes for 2029 Notes and Equitization Transaction”

New heading “Repayment of Term Loan”

New heading “Repayment at Maturity of Remaining 2026 Notes”

New heading “Equity Financing Transactions”

New heading “At the Market Sales Agreement”

New heading “Registered Direct Offering”

New heading “Share Repurchase Programs”

New heading “Gain on Sale of zaltenibart”

New heading “Gain on Early Extinguishment of Term Debt, Net”

New heading “Gain (Loss) on Early Extinguishment of 2026 Notes”

New heading “Gain (Loss) on Change in Fair Value of Financial Instruments, Net”

New heading “Income Tax Expense”

Removed heading “Gain on Early Extinguishment of Convertible Senior Notes”

Largest changes (selected automatically by length and topic keywords; quoted verbatim, no commentary)

Removed text topics: default, covenant
“The Credit Agreement contains certain customary default provisions, representations and warranties and affirmative and negative covenants, including a covenant for the Credit Parties to maintain at all times unrestricted cash, cash equivalents and short-term investments of at least $25.0 million in accounts subject to control agreements, and a covenant limiting the use of cash for open market or privately negotiated repurchases of any outstanding 2026 Notes to: …”
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Removed text topics: default, interest rate
“The Loans accrue interest at an adjusted term secured overnight financing rate, (“adjusted term SOFR”) (with a 3.00% floor) plus 8.75% per annum, payable quarterly. We may choose to pay up to 50% of any quarterly interest payment in kind by adding the portion of such interest payment to the outstanding principal amount of Loans using a quarterly interest rate of adjusted term SOFR (with a 3.00% floor) plus 10.25% per annum. …”
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“In recent years, we have incurred net losses from continuing operations and negative cash flows from operations. The recurring losses, in combination with our cash and investment balances as of December 31, 2024, expected repayment of a portion of the borrowings under our secured credit facility on or prior to November 1, 2025 and maturity of our 2026 Notes on February 15, 2026, raise substantial doubt about our ability to continue as a going concern through one year from the issuance of the Company's consolidated financial statements. …”
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Reworded

We are aan clinical-stageinnovative, biopharmaceuticalcommercial-stage biotechnology company committedthat to discovering, developingdiscovers and commercializingdevelops first-in-class small-moleculeprotein and proteinsmall-molecule therapeutics for large-market as well asand orphan indicationsindications, targetingwith immunologicparticular emphasis on complement-mediated diseases, including complement-mediated diseasescancers, and cancers related to dysfunction of the immune system, as well as addictive andor compulsive disorders.

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Lectin Pathway / MASP 2MASP-2

Reworded

The lead product and product candidate in our pipeline of complement-targeted therapeutics is narsoplimab (OMS721), a proprietary, patented human monoclonal antibody targeting MASP-2, the key activator of the lectin pathway of complement. Our lead lectin pathway inhibitor YARTEMLEA® (narsoplimab-wuug) is FDA-approved and commercially available in the U.S. for the treatment of TA-TMA in adult and pediatric patients aged two years and older. An MAA for YARTEMLEA in TA-TMA is currently under review by the EMA. Clinical development of narsoplimab is currentlyanticipated focusedto primarilycontinue onto expand the approved label in TA-TMA and to develop the drug in additional indications. Clinical development efforts arehave alsopreviously been directed to ARDS, including severe acute COVID-19, ARDSwhich andcan result in PASC. We are also developing OMS1029, our long-acting antibody targeting MASP-2MASP-2, which we expect will be well-suited to indications requiring long-term, chronic administration. In addition, we arehave advancingdirected ourefforts orallytowards administeredthe development of small-molecule MASP-2inhibitors inhibitorof throughMASP-2, IND-enablingdesigned studies.for oral administration. For more information, see Part I, Item 1 in this Annual Report on Form 10-K under the heading “Complement Inhibitor Programs: MASP-2 Program – Lectin Pathway Disorders”.

Added

Commercial Product – YARTEMLEA

Added

Our commercial product, YARTEMLEA, is the first and only approved inhibitor of the lectin pathway of complement. On December 23, 2025, FDA approved YARTEMLEA for the treatment of TA-TMA in adults and in children ages two years and older. TA-TMA is a severe and often-fatal complication of hematopoietic stem cell transplantation in adults and children, driven by systemic endothelial injury triggered by conditioning regimens, immunosuppressants, infection, graft-versus-host disease, and other transplant-related factors. Activation of the lectin pathway of complement plays a central role in disease pathogenesis. YARTEMLEA selectively inhibits MASP-2, blocking pathway activation while preserving classical and alternative complement functions important for host defense. In TA-TMA, MASP-2 inhibition prevents lectin pathway-mediated cellular injury, including endothelial damage in small blood vessels, and thrombus formation.

Added

Commercial distribution and sales of YARTEMLEA commenced in January 2026.

Added

For more information, see Part I, Item 1 in this Annual Report on Form 10-K under the heading “Overview: Our Commercial Product – YARTEMLEA”.

Reworded

AlternativeSale Pathwayof Zaltenibart / MASP-3

Reworded

OurOn pipelineNovember of25, clinical-stage2025, complement-targetedwe therapeuticcompleted candidatesthe alsoTransaction includespursuant to our APLA with Novo Nordisk for our candidate drug zaltenibart (formerly OMS906),. Zaltenibart is a proprietary,first-in-class, patentedlate-stage clinical humanized monoclonal antibody targeting MASP-3, the most upstream and key activator of the alternative pathway of complement.the Wecomplement believesystem. zaltenibartZaltenibart has theshown multiple potential toadvantages treat a wide range of alternative pathway-related diseases and that its attributes favorably differentiate zaltenibart fromover other marketed and in-development alternative pathway inhibitors.inhibitors in development and on the market.

Added

At the closing of the Transaction, we received an upfront cash payment of $240.0 million. In addition, we are eligible to receive (i) up to $510.0 million in one-time milestone payments upon the first achievement by Novo Nordisk or its affiliates or sublicensees of each of the development and approval milestone events as set forth in the APLA and (ii) up to $1.3 billion in one-time milestone payments upon the first achievement by Novo Nordisk or its affiliates or sublicensees of certain sales-based milestone events as set forth in the APLA. We are also eligible under the APLA to receive tiered royalties on annual net sales of products at percentage rates ranging from high single digit to high teens, subject to reduction in certain circumstances, as set forth in the APLA. In total, we are eligible to receive up to an additional $1.8 billion in potential development and commercial milestones, plus tiered royalties on net sales.

Added

Pursuant to the APLA, we sold and transferred, and Novo Nordisk purchased zaltenibart and certain related assets, and the parties agreed to grant and receive certain intellectual property licenses to facilitate the continued development and commercialization activities of both companies. We retain rights to our MASP-3 small-molecule program unrelated to zaltenibart, including the ability to develop and commercialize small-molecule MASP-3 inhibitors, across a range of therapeutic areas, including, but not limited to, ophthalmology, neurology, gastrointestinal disorders, dermatology, musculoskeletal diseases, and oncology. We also retain rights to our “grandfathered” MASP-3 antibodies, with temporal and indication restrictions on commercialization and for use in advancing our small-molecule therapeutics.

Added

In accordance with the APLA, at the closing of the Transaction, Omeros and Novo Nordisk entered into the Transition Services Agreement pursuant to which we are providing certain transition services to Novo Nordisk to facilitate the transfer of the acquired assets and liabilities under the APLA and to provide for the continued operation of relevant studies and program activities during the applicable term. Subject to certain exceptions and limitations, Novo Nordisk reimburses us for costs and expenses we incur under the Transition Services Agreement, including third-party costs and expenses, costs associated with delivery of transition services by Omeros personnel on an hourly basis at rates specified in the Transition Services Agreement, and for our inventories of zaltenibart drug substance and product.

Removed

Clinical development of zaltenibart is currently focused on PNH and C3G. We have initiated our Phase 3 clinical development program for zaltenibart in PNH and have an ongoing Phase 2 clinical trial evaluating zaltenibart in C3G. For more information, see Part I, Item 1 in this Annual Report on Form 10-K under the heading “Complement Inhibitor Programs: MASP-3 Program – Alternative Pathway Disorders”.

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PDE7Other InhibitorDevelopment Programs

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PDE7 Inhibitor Program

Reworded

Our PDE7 inhibitor program, which we refer to as OMS527, comprises multiple PDE7 inhibitor compounds and is based on our discoveries of previously unknown links between PDE7 and any addiction or compulsive disorder, and between PDE7 and any movement disorders. In April 2023, we were awarded a grant from the National Institute on Drug Abuse,NIDA, part of the National Institutes of Health, to develop our lead orally administered PDE7 inhibitor compound, for which we have successfully completed a Phase 1 study, for the treatment of cocaine use disorder (“CUD”).disorder. With NIDA funding, we successfully completed preclinical cocaine interaction/toxicology studies to assess safety of the OMS527 compound when co-administered with cocaine. BasedFDA onsubsequently requested additional preclinical information prior to initiating the successfulclinical outcomein-patient ofstudy thein preclinicalcocaine studies,users. Together with our collaborators at NIDA, we haveare initiated,scheduled andto NIDA has confirmed availability of grant funding for, an in-patient, placebo-controlled clinical study evaluating the safety and effectiveness of OMS527 in adultsmeet with CUDFDA whoto receivediscuss concurrentthat intravenous cocaine.request. For more information, see Part I, Item 1 in this Annual Report on Form 10-K under the heading “Other ClinicalDevelopment Programs: PDE7 Inhibitor Programs – OMS527”.

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Preclinical Programs - Oncology PlatformOncotoX-AML

Added

We continue to progress preclinical studies within our novel oncology program, which is focused on developing novel, proprietary large molecule therapeutics designed to selectively target and kill dividing cancer cells. We have completed selection of a drug development candidate, and IND-enabling studies are underway for this program, which we refer to as OncotoX-AML. AML, an aggressive and highly fatal bone marrow and blood cancer, is the lead indication for development. The effectiveness of current AML treatments, such as chemotherapeutics and antibody-drug conjugates, is limited by a number of factors, including high relapse rates and substantial side effects.

Added

OncotoX-AML is an engineered biologic designed to selectively kill both AML blasts (abnormal myeloid cells) and relapse-related leukemia stem cells. Its unique mechanism of action is independent of myeloid cell genetic mutations, including TP53, NPM1, KMT2A, and FLT3, which are collectively found in approximately 90% of AML patients and are historically difficult to treat. For more information, see Part I, Item 1 in this Annual Report on Form 10-K under the heading “Other Development Programs: OncotoX-AML”.

Added

Preclinical Programs - T-CAT

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We are also advancing our T-CAT platform: a new class of recombinant antibodies intended for broad action against bacteria, fungi, viruses, and parasites. T-CAT is designed to harness complement activation to kill pathogens directly, which represents a novel approach to infectious disease treatment.

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As preclinical animal data continue to accumulate across multiple pathogen classes and species, we believe that T-CAT demonstrates potential against MDROs. Effective MDRO therapies remain one of the most urgent and unmet needs in medicine, and we believe that T-CAT has the potential to address this need without contributing to drug resistance. For more information, see Part I, Item 1 in this Annual Report on Form 10-K under the heading “Other Development Programs: T-CAT - Infectious Disease”.

Removed

We are developing a portfolio of signaling-driven immunomodulators, oncotoxins, and an adoptive T-cell technology combined with an immunostimulator that, unlike other cellular therapy approaches requires no cellular engineering, may reduce manufacturing costs and timelines, and may maintain an enhanced anti-cancer immune response through subsequent repetitive and simple therapeutic administrations.

Removed

Our oncology development program is operating in stealth mode as we continue to confirm our results and to generate new data which we expect will contribute to our intellectual property position. For more information, see Part I, Item 1 in this Annual Report on Form 10-K under the heading “Preclinical Programs and Platforms: Oncology Platform”.

Reworded

We previously developed and commercialized OMIDRIA® (phenylephrine and ketorolac intraocular solutions) 1%/0.3%, which is approved by FDA for use during cataract surgery or intraocular lens replacement (“IOL”) to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain. We marketed OMIDRIA in the U.S. from the time of its commercial launch in 2015 until December 2021.

Added

On December 23, 2021, we sold OMIDRIA to Rayner pursuant to an Asset Purchase Agreement, dated December 1, 2021 (the “Asset Purchase Agreement”). In February 2023, we received a $200.0 million milestone payment from Rayner (the “Milestone Payment”), plus accrued interest, upon an event (the “Milestone Event”) that established separate payment for OMIDRIA for a continuous period of at least four years when furnished in an ambulatory surgery center (“ASC”) setting. The Asset Purchase Agreement also provides for the payment of royalties by Rayner based on Rayner's net sales of OMIDRIA for a term that extends for the life of the patents covering OMIDRIA in the relevant jurisdiction, the longest of which in the United States is currently into 2035. The applicable royalty rates are currently 30% in the United States and 15% outside the United States (“ex-U.S.”), subject to reduction upon certain events described in the Asset Purchase Agreement.

Removed

On December 23, 2021, we sold our commercial product, OMIDRIA, to Rayner. Rayner paid us $126.0 million at the closing and we retained all outstanding accounts receivable, accounts payable and accrued expenses as of the closing date.

Removed

As contemplated by the Asset Purchase Agreement, in December 2022, we earned a $200.0 million Milestone Payment upon the establishment of separate payment for OMIDRIA for a continuous period of at least four years when furnished in the ASC setting. We received $200.0 million in February 2023. Upon achieving the Milestone Event, the royalty rate applicable to U.S. net sales of OMIDRIA was reduced from 50% to 30%. The 30% royalty rate continues until the expiration or termination of the last issued and unexpired U.S. patent, which we expect to occur no earlier than 2035.

Reworded

As a result of the OMIDRIA divestiture, we recorded an OMIDRIA contract royalty asset on our consolidated balance sheet. The results of OMIDRIA activities are classified as discontinued operations in our consolidated statements of operations and comprehensive income (loss) and excluded from continuing operations for all periods presented. See Part II, Item 8, “Note 78 — Discontinued Operations – Sale of OMIDRIA” to our Consolidated Financial Statements in this Annual Report on Form 10-K.

Reworded

On September 30, 2022, we soldentered tointo a Royalty Purchase Agreement (the “Original Agreement”) with DRI anHealthcare interestAcquisitions LP (“DRI”) under which we received $125.0 million in exchange for a portion of ourthe futureroyalties OMIDRIA royalty receipts for $125.0 millionto which we recordedwere asentitled anfrom Rayner under the Asset Purchase Agreement on global net sales of OMIDRIA royaltybetween obligationSeptember 1, 2022 and December 31, 2030, subject to certain annual caps on ourthe consolidatedroyalty balanceamounts sheet.payable to DRI. DRI was entitled under that arrangement to receive royalties on OMIDRIA net sales between September 1, 2022 and December 31, 2030, subject to certain annual caps.

Added

On February 1, 2024, we sold an expanded interest in our future OMIDRIA royalties to DRI under an Amended and Restated Royalty Purchase Agreement (the “Amendment”) for which we received $115.5 million in cash consideration. We record the amounts payable to DRI as an OMIDRIA royalty obligation on our consolidated balance sheet. The Amendment eliminated the previously existing annual caps on royalty payments after January 1, 2024, and provides that DRI receives all royalties on U.S. net sales of OMIDRIA payable between January 1, 2024 and December 31, 2031. All royalties earned on OMIDRIA sales within the U.S. through December 31, 2031 are remitted by Rayner to an escrow account established by Omeros, from which payments are made to DRI.

Added

We retain the rights to receive all royalties payable by Rayner on any net sales of OMIDRIA outside the U.S. as well as royalties on global net sales of OMIDRIA payable from and after December 31, 2031. To date, international royalties have not been significant.

Added

DRI has no recourse to our assets other than its interest in OMIDRIA royalties. Interest expense on the OMIDRIA royalty obligation is recorded as a component of continuing operations. See Part II, Item 8, “Note 9 – OMIDRIA Royalty Obligation” to our Consolidated Financial Statements in this Annual Report on Form 10-K for additional information.

Added

Debt Financing Transactions

Removed

On February 1, 2024, we sold an expanded interest in our future OMIDRIA royalties to DRI and received $115.5 million in cash consideration, which we recorded as an addition to the OMIDRIA royalty obligation. The amended and restated royalty purchase agreement with DRI (the “Amendment”) eliminated the previously existing annual caps on royalty payments after January 1, 2024, and provides that DRI receives all royalties on U.S. net sales of OMIDRIA payable between January 1, 2024 and December 31, 2031. In addition to the cash consideration received at closing, the Amendment also entitles us to receive two milestone payments of up to $27.5 million each, payable in January 2026 and January 2028, respectively, based on achievement of certain thresholds for U.S. net sales of OMIDRIA. All royalties earned on OMIDRIA sales within the U.S. through December 31, 2031 are remitted by Rayner to an escrow account established by Omeros, from which payments are made to DRI. We retain the rights to receive all royalties payable by Rayner on any net sales of OMIDRIA outside the U.S. as well as royalties on global net sales of OMIDRIA payable from and after December 31, 2031, including royalties on U.S. OMIDRIA net sales. To date, international royalties have not been significant. DRI has no recourse to our assets other than its interest in OMIDRIA royalties. Interest expense on the OMIDRIA royalty obligation is recorded as a component of continuing operations. See Part II, Item 8, “Note 8 – OMIDRIA Royalty Obligation” to our Consolidated Financial Statements in this Annual Report on Form 10-K for additional information.

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PaymentRepayment onat Maturity of 2023 Notes

Reworded

2024 Term Loan and Repurchase of 2026 Notes for Cash

Added

Exchange of 2026 Notes for Term Loan and Cash

Added

On June 3, 2024, we, with certain subsidiaries, as guarantors, entered into a Credit and Guaranty Agreement (the “Credit Agreement”) with certain funds managed by Athyrium Capital Management, LP and certain funds managed by Highbridge Capital Management, LLC, as lenders (together with additional lenders from time to time, the “Lenders”) and Wilmington Savings Fund Society, FSB, as administrative agent and collateral agent. Along with borrowings of $67.1 million under the Credit Agreement (the “Term Loan”) and $21.7 million of cash on hand (for a total aggregate purchase price of $88.8 million), we repurchased from the lenders $118.1 million aggregate principal amount of our 2026 Notes. The $29.3 million difference between the $118.1 million aggregate principal amount of the 2026 Notes and the $88.8 million aggregate repurchase price was recorded as a premium (i.e., an increase) to the Term Loan on the Company’s consolidated balance sheet instead of being recognized as a gain on early extinguishment of debt as this was accounted for as a troubled debt restructuring.

Added

Exchange of 2026 Notes for 2029 Notes and Equitization Transaction

Added

On May 14, 2025, we completed the exchange (the “Convertible Note Exchange”) of $70.8 million of our 2026 Notes on a one-for-one basis for newly-issued 2029 Notes. The Convertible Note Exchange was conducted with a limited number of holders of the 2026 Notes pursuant to exchange agreements dated as of May 12, 2025. The 2029 Notes are convertible at the option of the holders into shares of common stock, cash or a combination thereof, as elected by the Company, at any time prior to the close of business on the second scheduled trading day immediately preceding the maturity date. Holders who convert their 2029 Notes after November 13, 2025 and prior to June 1, 2029 (except for any conversion in connection with a make-whole fundamental change) are entitled to an interest make-whole payment equal to the sum of the remaining scheduled payments of interest that would have been made had the 2029 Notes remained outstanding from their conversion date through the earlier of (i) the date that is 18 months following their conversion date, and (ii) June 15, 2029, the maturity date. The initial conversion rate for the 2029 Notes is equivalent to an initial conversion price of approximately $6.18 per share of our common stock. The conversion rate is subject to adjustment in certain circumstances.

Added

The 2029 Notes include both a derivative for the interest make-whole feature and a derivative for the conversion feature available to holders allowing them to convert their notes to common stock, cash or a combination thereof. At each reporting date, we remeasure the embedded derivative instruments to fair market value. Increases or decreases in our stock price may materially affect the fair value of the derivative. The remeasurement of the derivative is presented in our consolidated statement of operations and comprehensive loss. At contract inception, we recorded a net $23.0 million embedded derivative as a component of our 2029 Notes. However, with the sale of OMS906 to Novo Nordisk and the announcement of FDA approval of TA-TMA, our stock price significantly increased. At December 31, 2025, the fair market value of our embedded derivative was $157.2 million. We marked-to-market the initial $23.0 million embedded derivative on the 2029 Notes and recorded a $134.2 million non-cash loss on remeasurement to our consolidated statement of operations and comprehensive loss.

Added

On May 12, 2025, we entered into the note conversion agreements (each, a “Note Conversion Agreement”) with two holders of the 2026 Notes to convert $10.0 million aggregate principal amount of 2026 Notes into shares of our common stock in three tranches. We completed the conversion of the final tranche in September 2025, resulting in the issuance of an aggregate of 2,819,866 shares of our common stock to the two holders in exchange for the $10.0 million aggregate principal amount of 2026 Notes. We did not receive new cash proceeds in these transactions. We performed an assessment of the Convertible Note Exchange and Equitization Transaction and determined that these transactions were not a troubled debt restructuring and were a partial extinguishment of our 2026 Notes.

Added

These transactions resulted in a net $3.0 million non-cash loss on extinguishment of the 2026 Notes due to (1) expensing of the unamortized debt issuance costs of the extinguished 2026 Notes, (2) recording the 2029 Notes to fair market value (i.e., at a discount) which we recorded both to our statement of operations and comprehensive loss and as debt on our balance sheet and (3) recording the fair market value of the share-settled liability upon settlement.

Added

Repayment of Term Loan

Added

On November 25, 2025, concurrent with the closing of the sale and licensing of zaltenibart (OMS906) to Novo Nordisk under the APLA, we were required under the terms of the Credit Agreement to repay in full the $67.1 million principal outstanding under the Term Loan along with a 5% prepayment premium. We recognized a net non-cash gain on extinguishment in the amount of $17.0 million which represents the de-recognition of $17.9 million in unamortized premium and debt issuance costs, derecognition of $2.6 million of embedded derivatives, partially offset by $3.5 million of prepayment premium and related transaction expenses.

Added

Repayment of our obligations under the Credit Agreement resulted in the release in full of all liens and covenants thereunder including the covenant requiring us to maintain a minimum of $25.0 million in unrestricted cash, cash equivalents and short-term investments at all times.

Added

Repayment at Maturity of Remaining 2026 Notes

Added

On February 17, 2026, we repaid the remaining $17.1 million aggregate principal amount of outstanding 2026 Notes in full upon maturity.

Added

See Part II, Item 8, “Note 7 – Debt” and “Note 12 – Shareholders Equity (Deficit)” to our Consolidated Financial Statements in this Annual Report on Form 10-K for additional information on any of these refinancing transactions.

Added

Equity Financing Transactions

Added

At the Market Sales Agreement

Added

We have a sales agreement to sell shares of our common stock from time to time, through an “at the market” (“ATM”) equity offering program. During the year ended December 31, 2025, we sold 4.4 million shares of common stock pursuant to our ATM program, generating $19.0 million in net proceeds at an average price per share of $4.51. On November 14, 2025, the Company filed a shelf registration statement and prospectus supplement renewing the ATM program for an aggregate offering price up to $150.0 million, and as of the date of this annual report, we have $150.0 million in shares of our common stock available to sell under our ATM program.

Added

Registered Direct Offering

Added

On July 28, 2025, we issued and sold 5,365,853 shares of our common stock in a registered direct offering to entities managed by Polar Asset Management Partners at a price of $4.10 per share, representing a 14% premium to the closing price of our common stock on the date of the definitive agreement for the purchase of shares. We received $20.3 million in cash proceeds net of offering expenses.

Added

Share Repurchase Programs

Added

On November 9, 2023, the Board of Directors approved a share repurchase program under which we were permitted to repurchase from time to time up to $50.0 million of our common stock in the open market or through privately negotiated transactions. For the year ended December 31, 2023, we repurchased and retired 1.8 million shares of common stock at an average price of $2.54 per share for an aggregate purchase price of $4.7 million. During the first quarter of 2024, we repurchased and retired 3.2 million shares of common stock at an average of $3.71 per share for an aggregate purchase price of $11.9 million. The terms of the Credit Agreement prohibited us from repurchasing our common stock unless expressly agreed to by the Lenders. Consequently, the Board of Directors terminated the share repurchase program effective upon the execution of the Credit Agreement in May 2024. Repayment of our obligations under the Credit Agreement resulted in the release in full of all liens and covenants thereunder including the covenant prohibiting the Company from repurchasing its shares.

Added

On November 29, 2025, the Board of Directors approved a new share repurchase program under which we are permitted to repurchase from time to time up to $100.0 million of our common stock in the open market or through privately negotiated transactions.

Added

See Part II, Item 8, “Note 12 – Shareholders Equity (Deficit)” to our Consolidated Financial Statements in this Annual Report on Form 10-K for additional information on any of these refinancing transactions.

Removed

On June 3, 2024 (the “Closing Date”), we, with certain subsidiaries, as guarantors, entered into the Credit Agreement with Athyrium and Highbridge as lenders (together with additional lenders from time to time, the “Lenders”) and Wilmington Savings Fund Society, FSB, as administrative agent and collateral agent. The Credit Agreement provides for a senior secured term loan facility initially of up to $92.1 million consisting of (i) the Initial Term Loan of $67.1 million, which was fully funded on the Closing Date, and (ii) a $25.0 million Delayed Draw Term Loan, which may be drawn once in full upon notice delivered on or prior to June 3, 2025, conditioned on receipt of FDA approval of narsoplimab in TA-TMA within 30 days of the notice. We do not expect that FDA approval of narsoplimab will be obtained within a timeframe that would permit the Delayed Draw Term Loan to be drawn absent an amendment to, or waiver of, this condition. Proceeds of the Delayed Draw Term Loan, if borrowed, must be used to fund the commercialization of narsoplimab and to pay transaction costs associated with the Delayed Draw Term Loan. The Initial Term Loan has no original issue discount, while the Delayed Draw Term Loan, if drawn, would be issued with an original issue discount of 3.00%.

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What changed in the latest 10-Q

Comparing 10-Q filed 2026-08-12 (period ending 2026-06-30) with 10-Q filed 2026-05-13 (period ending 2026-03-31).

Risk Factors (10-Q Part II, Item 1A)

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In November 2025, our boardBoard of directorsDirectors authorized a share repurchase program to repurchase, from time to time, up to $100.0 million of our common stock in the open market or through privately negotiated transactions. The share repurchase program does not have a fixed expiration date, may be suspended or discontinued at any time, and does not obligate us to acquire any amount of our common stock. The timing, manner, price, and amount of any repurchases may be determined by us at our discretion and will depend on a variety of factors, including business, economic and market conditions, prevailing stock prices, corporate and regulatory requirements, and other considerations. As of MayAugust 11,12, 2026, approximately $95.9$90.1 million remained available to repurchase our outstanding shares of common stock under the share repurchase program.
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In November 2025, our boardBoard of directorsDirectors authorized a share repurchase program to repurchase, from time to time, up to $100.0 million of our common stock in the open market or through privately negotiated transactions. The share repurchase program does not have a fixed expiration date, may be suspended or discontinued at any time, and does not obligate us to acquire any amount of our common stock. The timing, manner, price, and amount of any repurchases may be determined by us at our discretion and will depend on a variety of factors, including business, economic and market conditions, prevailing stock prices, corporate and regulatory requirements, and other considerations. As of MayAugust 11,12, 2026, approximately $95.9$90.1 million remained available to repurchase our outstanding shares of common stock under the share repurchase program.

Management's Discussion & Analysis (MD&A) (10-Q Part I, Item 2)

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New text topics: european commission, labor
“In June 2026, the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) adopted a negative opinion on our marketing authorization application (“MAA”) for narsoplimab in TA-TMA. We believe the clinical evidence supports approval and have requested re-examination. As part of that procedure, an Ad Hoc Expert Group, expected to comprise external scientific and clinical experts in hematology and stem cell transplantation, will review the evidence and address questions central to CHMP’s assessment. …”
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Reworded topics: restructuring, liquidity

Paragraph as it now reads, with added and removed wording marked:

From time to time, we may seek to repurchase, redeem, retire, refinance, exchange or otherwise restructure portions of our outstanding indebtedness through open-market purchases, privately negotiated transactions, tender offers or other means. Any such transactions will depend on prevailing market conditions, our liquidity and capital requirements, contractual restrictions and other factors. Should it be necessary or determined to be strategically advantageous, we also could pursue debt transactions or public and private offerings of our equity securities, debt transactions or restructurings, future royalty sales, or other strategic transactions, which may include licensing or selling a portion or all of one or more of our existing technologies. In addition, we have an at-the-market (“ATM”) facility agreement under which we have the capability to sell shares of our common stock, from time to time, in an ATM equity offering through which we may offer and sell shares of our common stock equaling an aggregate amount of up to $150.0 million.
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Removed text topics: european commission, labor
“An MAA for YARTEMLEA in TA-TMA has been submitted to the EMA and is being reviewed under EMA’s centralized review procedure, which allows review of a single marketing authorization application. If the MAA is approved, it would authorize the product to be marketed in all European Union (“EU”) member states and European Economic Area countries. The European Commission has granted narsoplimab designation as an orphan medicinal product for treatment in hematopoietic stem cell transplantation. …”
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Removed text topics: investigation
“Clinical development of narsoplimab is anticipated to continue expanding the approved label in TA-TMA and to develop the drug in additional indications. Clinical development efforts have previously been directed to acute respiratory distress syndrome (“ARDS”), including severe acute COVID-19, which can result in post-acute sequelae of SARS-CoV-2 infection (“PASC,” i.e., long COVID). We are also developing OMS1029, our long-acting antibody targeting MASP-2, which we expect will be well-suited to indications requiring long-term, chronic administration. …”
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Removed text topics: covenant
“On November 25, 2025, concurrent with the closing of the sale and licensing of zaltenibart to Novo Nordisk under the APLA, we were required under that certain Credit and Guarantee Agreement, dated June 3, 2024 (the “Credit Agreement”) to repay in full the $67.1 million principal balance outstanding (the “Term Loan”) along with a 5% prepayment premium. Repayment of our obligations under the Credit Agreement resulted in the release in full of all liens and covenants thereunder.”
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Removed text topics: liquidity
“See “Note 1 — Organization and Basis of Presentation, Liquidity and Capital Resources” in the Notes to the Condensed Consolidated Financial Statements included elsewhere in this Quarterly Report on Form 10-Q for further details.”
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Reworded

We are an innovative, commercial-stage biotechnology company that discovers and develops first-in-class protein and small-molecule therapeutics for large-market and orphan indications,indications. withOur particulardrug emphasisproduct YARTEMLEA® (narsoplimab-wuug) is commercially available in the U.S. for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) in adult and pediatric patients two years of age and older. Our diverse pipeline of development programs is focused on the treatment of complement-mediated diseases, cancers, and addictive or compulsive disorders.

Added

Our commercial product, YARTEMLEA, is the first and only approved inhibitor of the lectin pathway of complement. On December 23, 2025, FDA approved YARTEMLEA for the treatment of TA-TMA in adults and in children two years of age and older. TA-TMA is a severe and often-fatal complication of hematopoietic stem cell transplantation in adults and children, driven by systemic endothelial injury triggered by conditioning regimens, immunosuppressants, infection, graft-versus-host disease, and other transplant-related factors. Activation of the lectin pathway of complement plays a central role in disease pathogenesis. YARTEMLEA selectively inhibits MASP-2, blocking pathway activation while preserving classical and alternative complement pathway functions important for host defense. In TA-TMA, MASP-2 inhibition prevents lectin pathway-mediated cellular injury, including endothelial damage in small blood vessels, and thrombus formation. Unlike other complement inhibitors, YARTEMLEA has no boxed warning and no Risk Evaluation and Mitigation Strategy (REMS), and vaccinations are not required prior to treatment.

Added

We are commercializing YARTEMLEA in the U.S. market and have deployed our field force of account managers and directors, market development managers, access leads, and medical science liaisons to engage directly with transplant centers across the U.S. There are 175 stem-cell transplant centers across the U.S., with the top 80 centers representing approximately 80% of procedures. Our field force is actively engaging all 175 U.S. transplant centers. By June 30, 2026, 73 unique accounts had ordered YARTEMLEA, representing a 143% increase in ordering accounts since March 31, 2026.

Added

At this early stage, our primary launch objectives are fourfold: (i) educate the entire transplant care team, including transplant physicians, nurses, hospital pharmacies, and reimbursement teams, regarding the recently harmonized TA-TMA diagnostic criteria, thereby driving awareness, early diagnosis, and treatment of TA-TMA; (ii) support transplant centers in obtaining their pharmacy and therapeutic committee approvals and adding YARTEMLEA to their formularies to streamline the ordering process and facilitate access to YARTEMLEA in both in- and out-patient settings; (iii) work with third-party payers to provide timely reimbursement consistent with the YARTEMLEA label and published diagnostic criteria; and (iv) finalize and prepare for presentation and publication of the health economics and outcomes research analysis using the strong clinical efficacy data and favorable safety profile of YARTEMLEA to demonstrate its compelling cost-effectiveness to healthcare providers and payors. Together, these factors are intended to shift the paradigm toward proactive screening for TA-TMA, with the goal of enabling clinicians to identify and treat more patients earlier, thus ultimately improving transplant outcomes.

Added

In June 2026, the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) adopted a negative opinion on our marketing authorization application (“MAA”) for narsoplimab in TA-TMA. We believe the clinical evidence supports approval and have requested re-examination. As part of that procedure, an Ad Hoc Expert Group, expected to comprise external scientific and clinical experts in hematology and stem cell transplantation, will review the evidence and address questions central to CHMP’s assessment. If the MAA is ultimately approved, it would authorize the product to be marketed in all European Union (“EU”) member states and European Economic Area countries, although there can be no guarantee that the re-examination will result in a reversal of CHMP’s negative opinion or the ultimate approval of the MAA. The European Commission has granted narsoplimab designation as an orphan medicinal product for treatment in hematopoietic stem cell transplantation. For potential commercialization of YARTEMLEA outside the U.S., including Europe, we are evaluating potential partnerships, including broad ex-U.S. and regional collaborations.

Reworded

The complement system plays a role in the body’s inflammatory response and becomes activated as a result of tissue damage or trauma or microbial pathogen invasion. Inappropriate or uncontrolled activation of the complement system can cause diseases characterized by serious tissue injury. Three main pathways can activate the complement system: classical, lectin, and alternative. We are focused on development of therapeutics to treat diseases associated with the lectin and/or alternative pathways of complement. We are developing antibodies as well as small-molecule inhibitors of key enzymes known to be centrally involved in the in activation of the targeted pathway of complement.

Added

Clinical development of YARTEMLEA is anticipated to continue expanding the approved label in TA-TMA and to develop the drug in additional indications. We are assessing further development opportunities across indications involving endothelial injury, lectin pathway activation, or thrombo-inflammation, including solid organ transplant-related TMA, chemotherapy-induced TMA, acute respiratory distress syndrome (“ARDS”), sickle cell disease, acute kidney injury, delayed graft function, and stem cell transplant-related endothelial syndromes, including diffuse alveolar hemorrhage, capillary leak syndrome, graft-versus-host disease, and sinusoidal obstruction syndrome. By year-end 2026, we expect enrollment to begin in two investigator-sponsored and Omeros-supported studies, one evaluating YARTEMLEA in hyperinflammatory ARDS, and the other assessing prophylactic YARTEMLEA in pediatric patients with predictably severe TA-TMA.

Added

We are also finalizing selection of an indication for a Phase 2 clinical program for OMS1029, our long-acting antibody targeting MASP-2, which we expect will be well-suited to indications requiring long-term, chronic administration once quarterly, either intravenously or subcutaneously. In addition, in our MASP-2 small molecule program, following the completion of one ongoing study, we expect to select a drug development candidate, targeting once-daily oral administration.

Removed

The lead product and product candidate in our pipeline of complement-targeted therapeutics is narsoplimab (OMS721), a proprietary, patented human monoclonal antibody targeting MASP-2, the key activator of the lectin pathway of complement. Our lead lectin pathway inhibitor YARTEMLEA® (narsoplimab-wuug) was approved by the Food and Drug Administration (“FDA”) in December 2025 and is commercially available in the U.S. for the treatment of TA-TMA in adult and pediatric patients aged two years and older. For more information, see “Commercial Product – YARTEMLEA” below.

Removed

Clinical development of narsoplimab is anticipated to continue expanding the approved label in TA-TMA and to develop the drug in additional indications. Clinical development efforts have previously been directed to acute respiratory distress syndrome (“ARDS”), including severe acute COVID-19, which can result in post-acute sequelae of SARS-CoV-2 infection (“PASC,” i.e., long COVID). We are also developing OMS1029, our long-acting antibody targeting MASP-2, which we expect will be well-suited to indications requiring long-term, chronic administration. In addition, we have selected a development candidate for our MASP-2 small molecule program, which is advancing to Investigational New Drug (“IND”)-enabling studies targeting once-daily oral administration.

Removed

Our commercial product, YARTEMLEA, is the first and only approved inhibitor of the lectin pathway of complement. On December 23, 2025, FDA approved YARTEMLEA for the treatment of TA-TMA in adults and in children ages two years and older. TA-TMA is a severe and often-fatal complication of hematopoietic stem cell transplantation in adults and children, driven by systemic endothelial injury triggered by conditioning regimens, immunosuppressants, infection, graft-versus-host disease, and other transplant-related factors. Activation of the lectin pathway of complement plays a central role in disease pathogenesis. YARTEMLEA selectively inhibits MASP-2, blocking pathway activation while preserving classical and alternative complement pathway functions important for host defense. In TA-TMA, MASP-2 inhibition prevents lectin pathway-mediated cellular injury, including endothelial damage in small blood vessels, and thrombus formation. Unlike other complement inhibitors, YARTEMLEA has no boxed warning and no Risk Evaluation and Mitigation Strategy (REMS), and vaccinations are not required prior to treatment.

Removed

We are commercializing YARTEMLEA in the U.S. market and have deployed our field force of account managers and directors, market development managers, access leads, and medical science liaisons to engage directly with transplant centers across the U.S. There are 175 stem-cell transplant centers across the U.S., with the top 80 centers representing approximately 80% of procedures. Our field force is detailing all 175 transplant centers nationwide. By March 31, 2026, 30 unique accounts had ordered YARTEMLEA.

Removed

At this early stage, our primary launch objectives are fourfold: (i) educate the entire transplant care team, including transplant physicians, nurses, hospital pharmacies, and reimbursement teams, regarding the recently harmonized TA-TMA diagnostic criteria, thereby driving awareness, early diagnosis, and treatment of TA-TMA; (ii) support transplant centers in obtaining their pharmacy and therapeutic committee approvals and adding YARTEMLEA to their formularies to streamline the ordering process and facilitate access to YARTEMLEA in both the in- and out-patient settings; (iii) work with third-party payers to provide timely reimbursement consistent with the YARTEMLEA label and published diagnostic criteria; and (iv) finalize and prepare for publication of the health economics and outcomes research analysis using the strong clinical efficacy data and favorable safety profile of YARTEMLEA to demonstrate its compelling cost-effectiveness to healthcare providers and payors.

Removed

An MAA for YARTEMLEA in TA-TMA has been submitted to the EMA and is being reviewed under EMA’s centralized review procedure, which allows review of a single marketing authorization application. If the MAA is approved, it would authorize the product to be marketed in all European Union (“EU”) member states and European Economic Area countries. The European Commission has granted narsoplimab designation as an orphan medicinal product for treatment in hematopoietic stem cell transplantation. For commercialization of YARTEMLEA outside the U.S., we are evaluating potential partnerships, including broad ex-U.S. and regional collaborations.

Reworded

SaleAlternative of ZaltenibartPathway / MASP-3

Reworded

At the closing of the Transaction, we received an upfront cash payment of $240.0 million. In addition, we are eligible to receive (i) up to $510.0 million in one-time milestone payments upon the first achievement by Novo Nordisk or its affiliates or sublicensees of each of the development and approval milestone events as set forth in the APLAAPLA, including $100.0 million in aggregate one-time milestone payments that we expect to be achievable in the near term, and (ii) up to $1.3 billion in one-time milestone payments upon the first achievement by Novo Nordisk or its affiliates or sublicensees of certain sales-based milestone events as set forth in the APLA. We are also eligible under the APLA to receive tiered royalties on annual net sales of products at percentage rates ranging from high single digit to high teens, subject to reduction in certain circumstances, as set forth in the APLA. In total, we have received and are eligible to receive up to an additional $1.8$2.1 billion in potential development and commercial milestones, plus tiered royalties on net sales.

Reworded

Pursuant to the APLA, we sold and transferred, and Novo Nordisk purchased zaltenibart and certain related assets, and the parties agreed to grant and receive certain intellectual property licenses to facilitate the continued development and commercialization activities of both companies. We retain rights to our entire MASP-3 small-molecule program unrelated to zaltenibart,program, including the ability to develop and commercialize small-molecule MASP-3 inhibitors, across a range of therapeutic areas, including, but not limited to, ophthalmology, neurology, gastrointestinal disorders, dermatology, musculoskeletal diseases, and oncology. We also retain rights to our “grandfathered” MASP-3 antibodies, with temporal and indication restrictions on commercialization and for use in advancing our small-molecule therapeutics.

Reworded

Our PDE7 inhibitor program, which we refer to as OMS527, comprises multiple PDE7 inhibitor compounds and is based on our discoveries of previously unknown links between PDE7 and any addiction or compulsive disorder, and between PDE7 and any movement disorder. In April 2023, we were awarded a grant from the National Institute on Drug Abuse (“NIDA”), part of the National Institutes of Health, to develop our lead orally administered PDE7 inhibitor compound, for which we have successfully completed a Phase 1 study, for the treatment of cocaine use disorder. With NIDA funding, we successfully completed preclinical cocaine interaction/toxicology studies to assess safety of the OMS527 compound when co-administered with cocaine. FDA subsequently requested additional nonclinical information prior to initiating the clinical in-patient study.trial. FollowingWe aare meetingcommencing withthe FDAnonclinical study, and we expect to discussbe that request, we are working with FDAable to streamlinestart theenrollment path to initiatein the in-patient clinical trial, which which is targeted for initiationtrial by year-end 2026.

Reworded

Preclinical Program - OncotoX-AML (OMS805)

Reworded

We continue to progress preclinical studies within our novel oncology program, which is focused on developing novel, proprietary large molecule therapeutics designed to selectively target and kill dividing cancer cells. We have completed selection of a drug development candidate, and IND-enabling studies are underway for this program, which we refer to as OncotoX-AML.OncotoX-AML or OMS805. Acute myeloid leukemia (“AML”), an aggressive and highly fatal bone marrow and blood cancer, is the lead indication for development. The effectiveness of current AML treatments, such as chemotherapeutics and antibody-drug conjugates, is limited by a number of factors, including high relapse rates and substantial side effects.

Reworded

In April 2025, we established the Omeros Oncology Clinical Steering Committee to help advance our OncotoX-AML program. The clinical steering committee is comprised of leaders in AML treatment and research at premier cancer centers. Together with this steering committee, we are designing our first in-human clinical trial.trial, which we are targeting to initiate in late 2027.

Added

Investigational New Drug (IND)-enabling studies are underway, and we have entered into an agreement with a leading contract biologics manufacturer for process development and initial clinical supply of OMS805 drug substance.

Removed

IND-enabling studies and manufacturing development work is ongoing within our OncotoX-AML program with the goal of entering the clinic by late 2027.

Added

T-CAT monoclonal antibodies were shown to safely and effectively treat infections in translationally relevant murine models of sepsis and pneumonia caused by Klebsiella pneumoniae, Pseudomonas aeruginosa, Streptococcus pneumoniae, and Neisseria meningitidis. We believe that the results of these studies demonstrate T-CAT’s potential as a next-generation platform with broad applicability across microbial species, including multidrug-resistant pathogens, and we intend to continue advancing T-CAT toward the clinic.

Removed

As preclinical animal data continue to accumulate across multiple pathogen classes and species, we believe that T-CAT demonstrates potential against multidrug-resistant organisms (“MDROs”). Effective MDRO therapies remain one of the most urgent and unmet needs in medicine, and we believe that T-CAT has the potential to address this need without contributing to drug resistance. We are currently working to complete preclinical proof of concept studies and evaluate data for several infectious diseases.

Reworded

ExchangeRepurchase of 2026 Notes for 2029 Notes

Added

In June and July 2026, we entered into privately negotiated agreements with certain holders of our unsecured convertible senior notes due 2029 (the “2029 Notes”) under which we agreed to repurchase approximately $30.5 million aggregate principal amount of 2029 Notes for a total purchase price of approximately $60.2 million, plus accrued and unpaid interest of $0.2 million. Both transactions closed in July 2026, leaving approximately $40.3 million aggregate principal amount of the 2029 Notes outstanding.

Added

For the three months ended June 30, 2026, the Company recognized a loss on extinguishment of the first tranche of debt of approximately $1.9 million, reflecting the difference between the fair value of the payment obligation of $30.6 million established on June 17, 2026, the carrying amount of the repurchased notes ($16.0 million in aggregate principal amount net of any unamortized discount and issuance costs), and the de-recognition of the associated embedded derivative liability of $16.7 million. In addition, the Company recognized a $0.7 million increase in the fair value of the payment obligation from June 17, 2026 through June 30, 2026 which reflects the cash consideration of $31.3 million paid at closing on July 6, 2026. As of June 30, 2026, the initial repurchase was classified as a $31.3 million current note repurchase obligation in our condensed consolidated balance sheet. The repurchase agreements for the second tranche, comprising $14.5 million aggregate principal amount, were entered into in July 2026. As such, the related accounting will be reflected in our third quarter filing. (For further detail, see “Note 6 — Debt — 2029 Notes” in the Notes to the Condensed Consolidated Financial Statements included elsewhere in this Quarterly Report on Form 10-Q.)

Removed

On May 14, 2025, we completed the exchange (the “Convertible Note Exchange”) of $70.8 million of our 5.25% convertible senior notes (the “2026 Notes”) on a one-for-one basis for newly issued convertible senior notes maturing on June 15, 2029 (the “2029 Notes”). The Convertible Note Exchange was conducted with a limited number of holders of the 2026 Notes pursuant to exchange agreements dated as of May 12, 2025. The 2029 Notes are convertible at the option of the holders into shares of common stock, cash or a combination thereof, as elected by the Company, at any time prior to the close of business on the second scheduled trading day immediately preceding the maturity date. Holders who convert their 2029 Notes prior to June 1, 2029 (except for any conversion in connection with a make-whole fundamental change) are entitled to an interest make-whole payment equal to the sum of the remaining scheduled payments of interest that would have been made had the 2029 Notes remained outstanding from their conversion date through the earlier of (i) the date that is 18 months following their conversion date, and (ii) June 15, 2029, the maturity date. The initial conversion rate for the 2029 Notes is equivalent to an initial conversion price of approximately $6.18 per share of our common stock. The conversion rate is subject to adjustment in certain circumstances.

Removed

The 2029 Notes include both a derivative for the interest make-whole feature and a derivative for the conversion feature available to holders allowing them to convert their notes to common stock, cash or a combination thereof. At each reporting date, we remeasure the embedded derivative instruments to fair market value. Increases or decreases in our stock price may materially affect the fair value of the derivative. The remeasurement of the derivative is presented in our condensed consolidated statement of operations and comprehensive income (loss). At contract inception, we recorded a net $23.0 million embedded derivative as a component of our 2029 Notes. See “Note 6 — Debt — 2029 Notes — Embedded Derivative” in the Notes to the Condensed Consolidated Financial Statements included elsewhere in this Quarterly Report on Form 10-Q for further details.

Removed

On November 25, 2025, concurrent with the closing of the sale and licensing of zaltenibart to Novo Nordisk under the APLA, we were required under that certain Credit and Guarantee Agreement, dated June 3, 2024 (the “Credit Agreement”) to repay in full the $67.1 million principal balance outstanding (the “Term Loan”) along with a 5% prepayment premium. Repayment of our obligations under the Credit Agreement resulted in the release in full of all liens and covenants thereunder.

Reworded

On February 17, 2026, we repaid the remaining $17.1 million aggregate principal balance outstanding on our 5.25% convertible senior notes (the “2026 Notes”) in full upon maturity.

Reworded

We have an “at the market” (“ATM”) facility agreement under which we have the capability to sell shares of our common stock from time to time, through an ATM equity offering program. On November 14, 2025, the Company filed a shelf registration statement and prospectus supplement renewing the ATM program for an aggregate offering price up to $150.0 million. We did not sell any shares under the ATM program during the three or six months ended MarchJune 31,30, 2026.

Reworded

On November 29, 2025, the Board of Directors approved a share repurchase program under which we are permitted to repurchase from time to time up to $100.0 million of our common stock in the open market or through privately negotiated transactions. During the three months ended MarchJune 31,30, 2026, we repurchased and retired 0.40.5 million shares of common stock pursuant to our share repurchase program, at an average cost of $11.70 per share, for an aggregate purchase price of $4.2$5.7 million. During the six months ended June 30, 2026, we repurchased and retired 0.8 million shares of common stock pursuant to our share repurchase program, at an average cost of $11.70 per share, for an aggregate purchase price of $9.9 million.

Reworded

As of MarchJune 31,30, 2026, we had cash, cash equivalents and short-term investments of $135.3$132.0 million. For the three months ended MarchJune 31,30, 2026, company-wide our cash provided by operations was $4.1 million. For the six months ended June 30, 2026, our cash used in operations was $14.5$10.4 million.

Removed

See “Note 1 — Organization and Basis of Presentation, Liquidity and Capital Resources” in the Notes to the Condensed Consolidated Financial Statements included elsewhere in this Quarterly Report on Form 10-Q for further details.

Reworded

Distribution and sales of our only commercial product, YARTEMLEA, commenced in January 2026. Product sales, net for the three months ended March 31, 2026 were $9.9 million, compared to no product revenue for the same period in the prior year. Revenue in the current period reflects initial sales of YARTEMLEA to wholesalers in the U.S.

Added

As YARTEMLEA is in the early stages of commercialization, period-over-period comparisons are of limited usefulness, and our product sales revenues mayfluctuate from quarter to quarter as physician adoption, patient access and ordering patterns continue to develop. For the three and six months ended June 30, 2026, gross revenues were $32.2 million and $43.4 million, respectively. The increase in revenue during the second quarter of 2026 primarily reflects continued physician adoption and increasing market penetration following product launch.

Removed

As this represents the first period of commercial sales, period-over-period comparisons are limited, and revenue mayfluctuate in future periods as we continue to expand patient access and physician adoption.

Added

Net revenues of $28.5 million and $38.4 million for the three and six months ended June 30, 2026, respectively, reflect gross-to-net adjustments of approximately 11.5% and 11.4%, respectively.

Reworded

We record YARTEMLEA product sales net of estimated chargebackschargebacks, distribution fees and distributionreturns, fees, or(collectively, gross-to-net deductions.deductions). Gross-to-net deductions are estimates based on contractual terms and expected utilization and require some judgment. For the three and six months ended MarchJune 31,30, 2026, no chargebacks were recorded related to Medicaid claims. AsBecause thisYARTEMLEA representsremains in the initialearly periodstages of commercial sales,commercialization, these estimates arecontinue preliminaryto be based on limited historical experience and are subject to change as additional information becomes available. A summary of our gross-to-net related accruals for the threesix months ended MarchJune 31,30, 2026 is as follows:

Reworded

Cost of product sold for the period was low, primarily reflecting the sale of inventory manufactured prior to regulatory approval, for which the associated manufacturing costs were expensed as research and development in prior periods. Accordingly, thisThis inventory carries a low or no cost basis, resulting in lower cost of product sold and higher gross margin during the initial commercialization period. Accordingly, cost of product sold for the three and six months ended June 30, 2026 primarily reflects stability testing, storage and royalty payments on our product sales.

Reworded

Our research and development expenses can be divided into three categories: direct external expenses, which include clinical research and development and preclinical research and development activities; internal overhead and other expenses; and stock-based compensation expense. Direct external expenses consist primarily of expenses incurred pursuant to agreements with third-party manufacturing organizations prior to receiving regulatory approval for a product candidate,organizations, contract research organizations, clinical trial sites, collaborators, licensors and consultants.consultants prior to receiving regulatory approval for a product candidate. Preclinical research and development includesinclude costs prior to beginning Phase 1 studies in human subjects. Internal overhead and other expenses primarily consist of costs for personnel, overhead, rent, utilities and depreciation. Our accounting policy is to expense all manufacturing costs related to product candidates until regulatory approval is reasonably assured in either the U.S. or EU.

Reworded

For the three and six months ended MarchJune 31,30, 2026, clinical research and development expenses decreased $7.2$5.9 million and $13.2 million, respectively, as compared to the prior year period as a result of reduced expenditures on OMS906 due to the sale of zaltenibart to Novo Nordisk. InternalFor the three and six months ended June 30, 2026, internal overhead and other expenses decreased $2.8$2.2 million and $4.9 million, respectively, as compared to the prior year period primarily due to Novo Nordisk reimbursing the Company for hours worked under the Transition Services Agreement and decreased employee compensation costs.

Reworded

We expect research and development expenses in the secondthird quarter of 2026 to be higher than in the firstsecond quarter of this year, driven primarily by increased investment in our YARTEMLEA and broaderour lectinother pathwayMASP-2 inhibitor programs as well as inand our OncotoX-AML program, including costs associated with manufacturing and related activities, clinical development efforts, and regulatory support for our YARTEMLEA MAA in Europe.activities.

Reworded

At this time, we are unable to estimate with certainty the longer-term costs we will incur in the continued development of our product candidates due to the inherently unpredictable nature of our preclinical and clinical development activities. Clinical development timelines, the probability of successsuccess, and development costs can differ materially as new data become available and as expectations change. Our future research and development expenses will depend, in part, on the preclinical or clinical success of each product candidate as well as ongoing assessments of each program’s commercial potential. In addition, we cannot forecast with precision which product candidates, if any, may be subject to future collaborations, when such arrangements will be secured, if at all, and to what degree such arrangements would affect our development plans and capital requirements.

Reworded

TotalFor the three and six months ended June 30, 2026, total selling, general and administrative expenses, excluding stock-based compensation, increased $2.6$3.7 million forand the$6.3 threemillion, months ended March 31, 2026, compared to the three months ended March 31, 2025,respectively, primarily due to the build-out of our U.S. commercial organization, including the hiring of a sales force and increased marketing and market access activities in support of the YARTEMLEA launch.

Removed

The $0.3 million decrease in stock-based compensation for the three months ended March 31, 2026 compared to the same period in the prior year is due to the valuation and timing of the vesting of employee stock options.

Reworded

We expect selling, general and administrative expenses in the secondthird quarter of 2026 to be higher than in the firstsecond quarter of 2026, driven primarily by increased selling and marketing activities associated with YARTEMLEA.

Reworded

Interest expense, net of premiums, discounts, issuance costscosts, and remeasurement adjustments is shown below:

Reworded

Contractual interest expense is comprised of cash interest paid during the year and the net change in accrued interest. Amortization of debt discounts, premiums and issuance costs are reflected as non-cash interest expense. Debt discounts on the 2026 Notes and 2029 Notes are accretive whereas the premium on the Credit and Guarantee Agreement with funds managed by Athyrium Capital Management LP and funds managed by Highbridge Capital Management, LLC, as lenders (the “Term Loan”) is deducted from contractual interest expense.

Reworded

For the three months ended MarchJune 31,30, 2026, interest expense increased $2.2$7.6 millionmillion, compared to the same period in 2025. The increase primarily relates to incurring a fullremeasurement quarterchange of interest on our 2029 Notes, which were not yet issued in the same periodoccurring in the prior year,year and to a lesser extent a non-cash remeasurement of our OMIDRIA royalty obligation. These increases are partiallyoffset by decreases in interestperiod related to the remainderOMIDRIA ofroyalty ourobligation 2026due Notes,to whicha were repaidchange in Februaryforecasted 2026,royalties andfrom the Term Loan, which was repaid in November 2025.Rayner.

Added

For the six months ended June 30, 2026, interest expense increased $9.8 million, compared to the same period in 2025. The increase primarily relates to a remeasurement change occurring in the prior year period related to the OMIDRIA royalty obligation due to a change in forecasted royalties from Rayner and additional interest incurred on our 2029 Notes as the notes were issued May 2025; however, we incurred a full six months of interest in the current year. These increases are partially offset by decreases in interest related to our 2026 Notes, which were repaid in February 2026, and the Term Loan, which was repaid in November 2025.

Reworded

For further informationdetails, please see “Note 6 — Debt” and “Note 8 – OMIDRIA Royalty Obligation” in the Notes to the Condensed Consolidated Financial Statements included elsewhere in this Quarterly Report on Form 10-Q.

Reworded

We expect interest expense for the secondthird quarter of 2026 to be higherlower than in the firstsecond quarter of 2026, assumingdriven noprimarily remeasurement adjustment toby the OMIDRIAdecreased contractaggregate royaltyprincipal obligation.amount of 2029 Notes outstanding.

Reworded

Interest and other income increased $0.4$3.4 million and $3.7 million, respectively, for the three and six months ended MarchJune 31,30, 2026 as compared to the same period in 2025 primarily due to thereimbursement receiptfrom ofNovo $0.7Nordisk millionfor ofinventory additionalwhich investmentwe incometransferred as a result of holding higher average cash and investment balances than induring the prior year period, partiallyoffset by decreased sublease income of $0.3 million for laboratory space.quarter.

Reworded

We expect interest and other income for the secondthird quarter of 2026 to be higherlower than in the firstsecond quarter of 2026.2026, reflecting the completion of planned transfers of zaltenibart inventory to Novo Nordisk.

Reworded

Net Gain (Loss) on Change in Fair Value of Financial Instruments

Reworded

Our embedded derivatives comprise interest make-whole and conversion options related to our 2029 Notes as well as call and put options related to the Term Loan. We repaid our Term Loan on November 25, 2025, thereby eliminating the Term Loan embedded derivative in the current year. The net gain of $11.4 million and $84.6 million on the 2029 Notes derivative for the three and Termsix Loan.months Asended ofJune March 31,30, 2026, the $73.1 million net gain on the embedded derivativesrespectively, reflects marking to market the option of the holders of the 2029 Notes to convert their notes into shares of common stock, cash or a combination thereof. As of March 31, 2026, we no longer have the derivative on our Term Loan as it was repaid on November 25, 2025.

Added

On June 17, 2026, the Company entered into privately negotiated agreements with certain holders of its 2029 Notes under which the Company agreed to repurchase a portion of the outstanding notes. For the three months ended June 30, 2026, the Company recognized a loss on extinguishment of debt of approximately $1.9 million. This loss reflects the difference between the fair value of the payment obligation of $30.6 million established on June 17, 2026 less the carrying amount of the repurchased notes (the aggregate principal of $16.0 million net of unamortized discount and issuance costs) and the de-recognition of the associated embedded derivative liability of $16.7 million.

Showing the first 60 of 77 changed paragraphs. The complete comparison will be part of Pro (coming soon). Meanwhile you can read the full text in the original filing.

OMER insider buying and selling (Form 4)

Since 2026-04-11, insiders reported open-market purchases in 0 Form 4 filings and open-market sales in 7 filings (4 insiders, 11 trade dates, 123,406 shares, about $2.3M; 4 of these filings say the sales were made under a Rule 10b5-1 trading plan). Net open-market shares: -123,406 (purchases minus sales); net value about -$2.3M.Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.

Trade dateInsiderTransactionSharesPriceValueOwned afterFiling
2026-09-23Borges David J.
VP, Finance & CAO
Option exercise
10b5-1 plan
10,000$15.58 $155.8K10,000 SEC
2026-09-23Borges David J.
VP, Finance & CAO
Open-market sale
10b5-1 plan
10,000$20.95 $209.5K0 SEC
2026-09-22Borges David J.
VP, Finance & CAO
Open-market sale
10b5-1 plan
10,000$20.95 $209.5K0 SEC
2026-09-22Borges David J.
VP, Finance & CAO
Option exercise
10b5-1 plan
5,000$3.93 $19.6K5,000 SEC
2026-09-22Borges David J.
VP, Finance & CAO
Option exercise
10b5-1 plan
5,000$2.94 $14.7K10,000 SEC
2026-08-31Cancelmo Peter B
VP, General Counsel
Open-market sale 25,000$18.54 $463.5K200 SEC
2026-08-31Cancelmo Peter B
VP, General Counsel
Option exercise 25,000$2.94 $73.5K25,200 SEC
2026-08-28Cancelmo Peter B
VP, General Counsel
Option exercise 25,000$2.94 $73.5K25,200 SEC
2026-08-28Cancelmo Peter B
VP, General Counsel
Open-market sale 25,000$18.65 $466.2K200 SEC
2026-08-27Hanish Arnold C
Director
Open-market sale 5,000$19.02 $95.1K0 SEC
2026-08-27Hanish Arnold C
Director
Option exercise 7,500$14.66 $110.0K10,000 SEC
2026-08-27Hanish Arnold C
Director
Open-market sale 5,000$18.88 $94.4K5,000 SEC
2026-08-27Hanish Arnold C
Director
Option exercise 2,500$15.81 $39.5K2,500 SEC
2026-08-26Hanish Arnold C
Director
Open-market sale 5,000$18.53 $92.7K0 SEC
2026-08-26Hanish Arnold C
Director
Option exercise 5,000$15.81 $79.0K5,000 SEC
2026-08-24Borges David J.
VP, Finance & CAO
Open-market sale
10b5-1 plan
906$19.10 $17.3K0 SEC
2026-08-24Borges David J.
VP, Finance & CAO
Option exercise
10b5-1 plan
906$2.94 $2.7K906 SEC
2026-08-21Borges David J.
VP, Finance & CAO
Option exercise
10b5-1 plan
5,906$3.93 $23.2K5,906 SEC
2026-08-21Borges David J.
VP, Finance & CAO
Open-market sale
10b5-1 plan
10,000$18.95 $189.5K0 SEC
2026-08-21Borges David J.
VP, Finance & CAO
Option exercise
10b5-1 plan
4,094$2.94 $12.0K10,000 SEC
2026-08-20Cable Thomas J.
Director
Option exercise 7,500$2.00 $15.0K42,567 SEC
2026-08-20Cable Thomas J.
Director
Open-market sale 15,000$18.45 $276.8K35,067 SEC
2026-08-20Cable Thomas J.
Director
Option exercise 7,500$3.93 $29.5K50,067 SEC
2026-08-13Borges David J.
VP, Finance & CAO
Open-market sale
10b5-1 plan
5,000$16.95 $84.8K0 SEC
2026-08-13Borges David J.
VP, Finance & CAO
Option exercise
10b5-1 plan
5,000$3.93 $19.6K5,000 SEC
2026-05-22Cable Thomas J.
Director
Open-market sale
10b5-1 plan
7,500$11.61 $87.1K35,067 SEC
2026-05-22Cable Thomas J.
Director
Option exercise
10b5-1 plan
7,500$10.84 $81.3K42,567 SEC

Well-known investors holding OMER (13F)

InvestorQuarterSharesReported value% of their 13FChange vs prior quarter
D. E. Shaw & Co. NOTE 9.500% 6/12026-06-300$34.7M0.02%No change
Two Sigma Investments COM2026-06-30402,662$3.8M0.0%Added 41%
Millennium Management (Israel Englander) COM2026-06-30343,839$3.3M0.0%Reduced 16%
Citadel Advisors (Ken Griffin) COM2026-06-3085,594$814.0K0.0%Reduced 67%
D. E. Shaw & Co. COM2026-06-3071,168$751.5K—Sold out
AQR Capital Management (Cliff Asness) COM2026-06-3029,726$282.7K0.0%Reduced 1%

13F reports are filed up to 45 days after quarter end and show long U.S. equity positions only; options positions are omitted here.

Coming soon: email alerts when OMER files, watchlists and downloadable comparisons.