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Item 1. Business

2026-03-31 compared with 2025-03-31 · 203 added, 308 removed, 502 unchanged (50% of the section changed)

Omeros Corporation (“Omeros,” the “Company” or “we”) is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting immunologic diseases, including complement-mediated diseases and cancers related to dysfunction of the immune system, as well as addictive and compulsive disorders.

Complement-targeted Therapeutic Development Programs

We are advancing multiple development programs focused on diseases and disorders associated with the complement system, a group of specialized proteins that protect against invasive pathogens as well as damaged cells inside the body and comprise an important part of the body’s immune system.

When triggered, the various components of complement cooperate to generate an immune response that fights infection and clears damaged or dead cells, maintaining healthy function of the body’s systems.

However, dysregulation of the complement system (i.e., over- or under-activation) can be harmful and is associated with increased vulnerability to infections and non-infectious diseases, including autoimmune disorders, chronic inflammation, thrombotic microangiopathy, and cancer.

There are three distinct pathways of complement, each activated via one or more unique mechanisms:

Classical pathway:

activated by antigen-antibody complexes

Lectin pathway:

activated by lectin binding of carbohydrate patterns on the surfaces of damaged cells and microbes

Alternative pathway:

constitutively active and amplifies classical and lectin pathway activation

Our complement-targeted therapeutic development programs are primarily focused on diseases and disorders associated with the lectin and/or alternative pathways of complement.

Omeros Corporation (“Omeros,” the “Company” or “we”) is an innovative, commercial-stage biotechnology company that discovers and develops first-in-class protein and small-molecule therapeutics for large-market and orphan indications, with particular emphasis on complement-mediated diseases, cancers, and addictive or compulsive disorders.

Our complement-targeted product, product candidates, and therapeutic programs are primarily focused on diseases and disorders associated with the lectin and/or alternative pathways of complement.

Our lectin pathway program includes inhibitors of mannan-binding lectin-associated serine protease 2 (“MASP-2”) and our alternative pathway program includes inhibitors of mannan-binding lectin-associated serine protease 3 (“MASP-3”).

Narsoplimab (OMS721), the lead product candidate in our pipeline of complement-targeted therapeutics, is a proprietary, patented human monoclonal antibody inhibitor of MASP-2, the key activator of the lectin pathway.

Clinical development of narsoplimab is currently focused primarily on hematopoietic stem cell transplant-associated thrombotic microangiopathy (“TA-TMA”).

We are also developing OMS1029, our long-acting antibody and an orally administered small molecule targeting MASP-2 and the lectin pathway.

The lead product candidate in our development program focused on the alternative pathway of complement is zaltenibart (OMS906), a proprietary, patented monoclonal antibody targeting MASP-3.

MASP-3 is the key and most proximal activator of the alternative pathway of complement.

We believe zaltenibart has the potential to treat a wide range of alternative pathway-related diseases and that its attributes favorably differentiate zaltenibart from other marketed and in-development alternative pathway inhibitors.

Clinical development of zaltenibart is currently ongoing in multiple alternative pathway-related disorders, including paroxysmal nocturnal hemoglobinuria (“PNH”), a rare and life-threatening hemolytic blood disorder, and complement 3 glomerulopathy (“C3G”), a rare chronic kidney disease.

A small molecule MASP-3 inhibitor intended for oral administration is also in development.

Other Development Programs

Our development pipeline also includes OMS527, our phosphodiesterase 7 (“PDE7”) inhibitor program focused on addiction and movement disorders.

We also have a diverse group of preclinical programs, including an oncology platform directed to development of novel therapeutics across a portfolio of signaling-driven immunomodulators, oncotoxins and an adoptive T-cell technology combined with an immunostimulator.

OMIDRIA Sale and Royalty Monetization Transactions

We previously developed and commercialized OMIDRIA ® (phenylephrine and ketorolac intraocular solution) 1%/0.3%, which is approved for use during cataract surgery or intraocular lens (“IOL”) replacement to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain.

We marketed OMIDRIA in the United States (the “U.S.”) from the time of its commercial launch in 2015 until December 2021.

On December 23, 2021, we sold OMIDRIA to Rayner Surgical Inc.

(“Rayner”) pursuant to an Asset Purchase Agreement, dated December 1, 2021 (the “Asset Purchase Agreement”).

Under the Asset Purchase Agreement, 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.

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, subject to reduction upon certain events described in the Asset Purchase Agreement.

On September 30, 2022, we entered into a Royalty Purchase Agreement (the “Original Agreement”) with DRI Healthcare Acquisitions LP (“DRI”) under which we received $125.0 million in exchange for a portion of the royalties to which we were entitled from Rayner under the Asset Purchase Agreement on global net sales of OMIDRIA between September 1, 2022 and December 31, 2030, subject to certain annual caps on the royalty amounts payable to DRI.

On February 1, 2024, we entered into an Amended and Restated Royalty Purchase Agreement (the “Amendment”) under which we sold to DRI an expanded interest in the OMIDRIA royalties.

The Amendment eliminated the annual caps on royalty payments to which DRI is entitled and provides that DRI will receive all royalties on U.S.

net sales of OMIDRIA payable between January 1, 2024 and 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.

DRI is entitled to payment only to the extent of royalty payments that are payable on U.S.

net sales of OMIDRIA on or before December 31, 2031 and DRI has no recourse to our assets other than our interest in the OMIDRIA royalties.

Omeros retains the right to receive all royalties payable by Rayner on any net sales of OMIDRIA outside the U.S.

payable from and after January 1, 2024, as well as all royalties on global net sales of OMIDRIA payable from and after December 31, 2031.

For further discussion, please refer to Part II, Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations – OMIDRIA Sale and Royalty Monetization Transactions.”

2024 Term Loan

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 (collectively, “Athyrium”) and certain funds managed by Highbridge Capital Management, LLC (collectively, “Highbridge”) as lenders and Wilmington Savings Fund Society, FSB, as administrative agent and collateral agent.

We have borrowed approximately $67.1 million under the Credit Agreement and pledged substantially all of our assets, including our intellectual property, as collateral, subject to customary exceptions, and excluding royalty interests in OMIDRIA and certain related rights.

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.

In addition, 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 5.25% convertible senior notes due on February 15, 2026 (the “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.

For additional information regarding the Credit Agreement and its associated risks, see Part II, Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations – 2024 Term Loan and Repurchase of 2026 Notes” and Part I, Item 1A, “Risk Factors” in this Annual Report on Form 10-K.

Our Commercial Product:

YARTEMLEA ® (narsoplimab-wuug)

YARTEMLEA ® (narsoplimab-wuug) is the first and only approved therapy for hematopoietic stem cell transplant-associated thrombotic microangiopathy (“TA-TMA”), an often-fatal complication of stem cell transplantation driven by activation of the lectin pathway of complement.

YARTEMLEA selectively inhibits MASP-2, the effector enzyme of the lectin pathway, blocking the pathway’s activation while preserving classical and alternative complement functions important for host defense against infection.

YARTEMLEA was approved by the U.S.

Food and Drug Administration (“FDA”) on December 23, 2025 for the treatment of TA-TMA in adult and pediatric patients aged two years and older.

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.

Commercial distribution and sales of YARTEMLEA began in January 2026.

A marketing authorization application (“MAA”) for YARTEMLEA in TA-TMA has been submitted to the European Medicines Agency (“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 EU member states and European Economic Area countries.

The European Commission (the “EC”) has granted narsoplimab designation as an orphan medicinal product for treatment in hematopoietic stem cell transplantation.

Our Partnered Program:

Zaltenibart (OMS906)

As part of our program to develop complement-targeted therapeutics, we identified MASP-3, which has been shown to be the key activator of the complement system’s alternative pathway (“APC”).

The complement system is part of the immune system’s innate response, and the APC is considered the amplification loop within the complement system.

MASP-3 is responsible for the conversion of pro-factor D to mature factor D;

which is necessary for the activation of the APC.

We believe that MASP-3 inhibitors have potential applications across a broad range of therapeutic areas and indications, including paroxysmal nocturnal hemoglobinuria (PNH), renal diseases such as immunoglobulin A nephropathy (IgAN), C3 glomerulopathy and atypical hemolytic uremic syndrome, as well as other immune and complement-driven disorders.

On November 25, 2025, we completed a transaction (the “Transaction”) pursuant to an Asset Purchase and License Agreement (“APLA”) between Omeros and Novo Nordisk Healthcare AG (“Novo Nordisk”), dated October 10, 2025, in which Novo Nordisk received exclusive global rights in all indications to develop and commercialize our lead investigational MASP-3 inhibitor, zaltenibart (formerly OMS906), and certain related compounds and products.

Zaltenibart is a first-in-class, late-stage clinical humanized monoclonal antibody targeting MASP-3, the most upstream and key activator of the alternative pathway of the complement system.

Zaltenibart has shown multiple potential advantages over other alternative pathway inhibitors in development and on the market.

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.

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.

In accordance with the APLA, at the closing of the Transaction, Omeros and Novo Nordisk entered into a transition services agreement (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.

Our Product Candidates and Development Programs

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Narsoplimab (MASP-2 / Lectin Pathway)

Hematopoietic stem-cell transplant-associated thrombotic microangiopathy (TA-TMA)

Resubmission of BLA completed

FDA review of BLA;

submission of MAA to EMA

Narsoplimab (MASP-2 / Lectin Pathway)

Severe COVID-19, post-acute sequelae of SARS-CoV-2 infection (PASC, i.e., long COVID) and other causes of acute respiratory distress syndrome (ARDS)

Phase 2 trial in severe COVID-19 completed

Continue development of narsoplimab and diagnostic for lectin pathway hyperactivation for ARDS and related indications

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)

Phase 2 clinical trial in severe COVID-19 completed, and animal studies completed in bacterially, virally, and chemically induced ARDS

Initiation of one or more Phase 2 clinical trials in ARDS

OMS1029 (MASP-2 / Lectin Pathway)

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Phase 1 studies completed

Select indication for Phase 2 development

Zaltenibart (MASP-3 / Alternative Pathway)

Paroxysmal nocturnal hemoglobinuria (PNH)

Phase 3 programs initiated

Complete Phase 3 clinical trials

Zaltenibart (MASP-3 / Alternative Pathway)

Complement 3 glomerulopathy (C3G) and other alternative pathway disorders

Phase 2 program ongoing

Complete Phase 2 study and initiate Phase 3 clinical trial

Finalize indication and initiate Phase 2 clinical trial

OMS527 (PDE7)

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other addictive and compulsive disorders;

Phase 1b study in adult CUD patients initiating with committed funding from National Institute on Drug Abuse (NIDA)

Complete NIDA-funded Phase 1b clinical trial in patients with cocaine use disorder

Phase 1b study in adult cocaine using subjects contracted and pending initiation with committed funding from National Institute on Drug Abuse (“NIDA”)

Complete NIDA-funded Phase 1b clinical trial in cocaine using subjects

Our pipeline of preclinical development programs includes the following:

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Lectin pathway disorders

Assess preclinical data on current drug development candidate

Final stage of selecting drug development candidate

Achieve clearance of an Investigational New Drug (“IND”) application to allow initiation of clinical trials

small-molecule inhibitors

Alternative pathway disorders

Identify drug development candidate for clinical trials

Adoptive T-Cell and Immunostimulator Combination Therapies

Wide range of cancers

Complete preclinical proof of concept studies and evaluate data

Oncotoxins and Immunomodulators

Wide range of cancers

Complete preclinical proof of concept studies and evaluate data

Assessing molecules to select a drug development candidate

Select drug development candidate for clinical trials

Acute myeloid leukemia

Completed selection of drug development candidate

Achieve clearance of an IND application to allow initiation of clinical trials

Targeted Complement Activating Therapy (T-CAT)

Multidrug-resistant organisms

Conducting animal studies to allow selection of initial drug development candidate for initial targeted multidrug resistant bacterial infectious disease

Select drug development candidate for clinical trials

Complement Inhibitor Programs

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 activation of the targeted pathway of complement.

We are a worldwide leader in complement science and in the development of therapeutics focused on modulating the activation of the complement system, a group of specialized proteins that comprise an important part of the body’s immune system and protect against invasive pathogens as well as damaged cells inside the body.

There are three distinct pathways of complement, each activated via one or more unique mechanisms:

Classical pathway:

activated by antigen-antibody complexes

Lectin pathway:

activated by lectin binding of carbohydrate patterns on the surfaces of damaged cells and microbes

Alternative pathway:

constitutively active and amplifies classical and lectin pathway activation

MASP-2 Program - Lectin Pathway Disorders

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We own or hold worldwide exclusive licenses to rights related to MASP-2, the antibodies targeting MASP-2 and the therapeutic applications for those antibodies.

Narsoplimab (OMS721)

The lead product candidate in our pipeline of complement-targeted therapeutics is narsoplimab (OMS721), a proprietary, patented human monoclonal antibody targeting MASP-2.

Narsoplimab is in clinical development for several indications.

Hematopoietic stem-cell transplant-associated thrombotic microangiopathy (“TA-TMA”):

In March 2025, we resubmitted to FDA a BLA seeking marketing approval for narsoplimab in TA-TMA.

FDA has 30 days to decide whether the application is sufficiently complete to permit a review of the BLA.

Assuming FDA agrees to review the BLA, we expect the resubmission to be classified as Type B, meaning that the target date for FDA action on the BLA under the Prescription Drug User Fee Act (“PDUFA”) is expected to be in September 2025.

As with any BLA or new drug application, there can be no guarantee that, even if FDA agrees to review the BLA, that FDA will complete its review within a given timeframe, or that our BLA will ultimately be approved.

We previously submitted a BLA for narsoplimab in TA-TMA, the clinical sections of which were based on results of the pivotal trial of narsoplimab in TA-TMA (OMS721-TMA-001), in which the drug met its primary endpoint of complete response compared to an efficacy threshold, where complete response required clinical improvements in TMA markers (platelet count and lactose dehydrogenase) and in organ function (renal pulmonary, gastrointestinal or neurological) or freedom from transfusion.

Despite the success on the primary endpoint and the unmet need in TA-TMA, in October 2021 FDA issued a complete response letter (“CRL”) with respect to the original BLA and indicated 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 potential paths for resubmission of the BLA, including paths based on comparison of survival data from the completed pivotal trial versus a historical control group.

Based on the recommendations included in the appeal decision and on subsequent interactions with FDA, we proposed a statistical analysis plan to assess data from our pivotal clinical trial, existing data from a historical control population available from an external source and data from the narsoplimab expanded access program.

The proposed protocol and statistical analysis plan were reviewed by FDA, and FDA’s recommendations were incorporated into the final versions.

All statistical analyses were conducted by an independent statistical group and the completed analyses are included in the resubmitted BLA for narsoplimab in TA-TMA.

The primary endpoint under the statistical analysis plan compared to overall survival in the 28 TA-TMA patients that received narsoplimab treatment in the OMS721-TMA-001 pivotal trial to overall survival of more than 100 similarly high-risk TA-TMA patients in an external control registry who did not receive narsoplimab treatment.

The OMS721-TMA-001 patients demonstrated clinically meaningful and statistically significant superiority in overall survival – a hazard ratio of 0.32 (95% confidence interval:

0.23 to 0.44) with p-value less than 0.00001 – compared to the TA-TMA patients in the external registry.

The robustness of these results is supported by the sensitivity analyses conducted, and confidence in the results is demonstrated by statistical tests intended to assess potential confounding effects.

Analyses similar to the primary analysis comparing survival in TA-TMA patients treated with narsoplimab under a global expanded access program (“EAP”) to that of similarly at-risk TA-TMA registry of patients were also included in the analysis plan, along with sensitivity analyses related to each of the primary and EAP comparisons.

The EAP-related analyses, which compare survival in narsoplimab-treated adult EAP patients and survival in similarly at-risk TA-TMA patients in the external control registry, further support the robustness and generalizability of the primary analysis results, with representative analyses of the combined EAP and pivotal trial patients yielding hazard ratios ranging from 0.34 (95% confidence interval:

0.21, 0.53) to 0.46 (95% confidence interval:

0.35, 0.60) and p-values ranging from less than 0.00001 to 0.00002.

Results of the primary-related and EAP-related sensitivity analyses performed as part of the statistical analysis plan support the robustness of the primary results.

The EAP includes adults and children and includes both treatment-naïve patients and patients who failed or stopped treatment for their TA-TMA prior to receiving narsoplimab.

Analyses of survival across all of these subgroups of patients treated with narsoplimab show consistently impressive survival results regardless of age or prior treatment status.

In the U.S., FDA has granted narsoplimab (1) breakthrough therapy designation in patients who have persistent TMA despite modification of immunosuppressive therapy, (2) orphan drug designation for the prevention (inhibition) of complement-mediated TMAs, and (3) orphan drug designation for the treatment of TA-TMA.

The European Commission (the “EC”) also granted narsoplimab designation as an orphan medicinal product for treatment in hematopoietic stem cell transplantation.

In Europe, the European Medicines Agency (“EMA”) has confirmed narsoplimab’s eligibility for the EMA’s centralized review of a single marketing authorization application (“MAA”) that, if approved, authorizes the product to be marketed in all EU member states and European Economic Area countries.

We are targeting to complete our MAA submission in the first half of 2025.

COVID-19 and Acute Respiratory Distress Syndrome ( “ ARDS ” ):

There is strong and increasingly well-established evidence of the central role of the lectin pathway in COVID-19 and acute respiratory distress syndrome (“ARDS”), and we have developed mechanistic, in vivo animal data, and proof-of-concept clinical data indicating that narsoplimab may be an effective therapeutic for COVID-19, ARDS and/or related indications.

We have also generated compelling data in established animal models across all forms of severe ARDS - bacterial, viral and chemical - and continue to explore the evidence that MASP-2 and the lectin pathway are important drivers of post-acute sequelae SARS-CoV-2 (“PASC”), commonly known as long COVID.

YARTEMLEA ® (narsoplimab)

The first FDA-approved product from our portfolio of complement-targeted therapeutics is YARTEMLEA (narsoplimab), a proprietary, patented human monoclonal antibody targeting MASP-2 and the lectin pathway of complement.

Narsoplimab was approved by FDA on December 23, 2025, becoming the first approved inhibitor of the lectin pathway, as well as the first and only approved treatment for TA-TMA.

For more information regarding commercialization of YARTEMLEA (“narsoplimab-wuug”), which is marketed in the U.S.

for the treatment of TA-TMA, see “Our Commercial Product:

YARTEMLEA ® (narsoplimab-wuug)” above.

We intend to continue clinical development of YARTEMLEA to evaluate potential opportunities to expand on the approved label in TA-TMA and to develop the drug as a treatment for indications other than TA-TMA.

Indications to which development efforts have been directed include the following:

There is strong and increasingly well-established evidence of the central role of the lectin pathway in ARDS, including severe acute COVID-19, which can result in PASC, i.e., long COVID.

We have developed mechanistic, in vivo animal data, and proof-of-concept clinical data indicating that narsoplimab may be an effective therapeutic for ARDS and/or related indications.

We have also generated compelling data in established animal models across all forms of severe ARDS - bacterially, virally, and chemically induced.

We are working to initiate one or more Phase 2 clinical trials in ARDS.

We have also developed an assay platform to identify hyperactivation of the lectin pathway.

Because lectin pathway hyperactivation is correlated with COVID-19-related-ARDS and may be involved in the pathogenesis of other forms of ARDS and/or PASC, the assay may be useful to identify patients with these conditions who are at greatest risk of hospitalization and/or mortality as well as those who are particularly amenable to lectin pathway inhibition therapy for the treatment of one or more of these conditions.

We continue to validate the clinical correlation of lectin pathway hyperactivation with COVID-19, ARDS and PASC and to engage in discussions with potential partners as well as with representatives of the U.S.

government regarding potential opportunities to obtain funding and advance development of our potential diagnostic and/or therapeutic product candidates for COVID-19, PASC and/or ARDS.

Our lectin pathway program also includes OMS1029, our long-acting antibody targeting MASP-2.

This next-generation MASP-2 inhibitor is intended to be complementary to narsoplimab, enabling us to pursue chronic indications in which dosing convenience would be of significant benefit to patients.

This next-generation MASP-2 inhibitor is intended to be complementary to YARTEMLEA, enabling us to pursue chronic indications in which dosing convenience would be of significant benefit to patients.

We have completed Phase 1 clinical trials evaluating both single-ascending and multiple-ascending doses of OMS1029.

Data from these trials demonstrated the feasibility of once quarterly, subcutaneous administration, representing a convenient regimen well-suited for chronically dosed indications that can be administered either in health care centers or at home.

We expect that there are multiple chronic indications that are well suited to treatment with OMS1029.

OMS1029 has been well tolerated to date with no safety concerns identified.

We continue to evaluate several potential indications for which Phase 2 clinical development of OMS1029 could be pursued, depending on resource availability.

We are working to finalize selection of an indication and initiate Phase 2 clinical development of OMS1029.

OMS1029 drug product and placebo have been manufactured and stored for future use.

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MASP-3 Program - Alternative Pathway Disorders

As part of our program to develop complement-targeted therapeutics, we have identified MASP-3, which has been shown to be the key activator of the complement system’s alternative pathway (“APC”), and we believe that we are the first to make this and related discoveries associated with the APC.

The complement system is part of the immune system’s innate response, and the APC is considered the amplification loop within the complement system.

MASP-3 is responsible for the conversion of pro-factor D to mature factor D;

which is necessary for the activation of the APC.

We believe that MASP-3 inhibitors have the potential to treat patients suffering from a wide range of diseases and conditions including:

multiple sclerosis;

neuromyelitis optica;

age-related macular degeneration;

Alzheimer’s disease;

systemic lupus erythematosus;

diabetic retinopathy;

chronic obstructive pulmonary disease;

antineutrophil cytoplasmic antibody-associated vasculitis;

anti-phospholipid syndrome;

atherosclerosis;

myasthenia gravis and others.

Several of these indications have been clinically validated by other agents targeting the APC.

Our MASP-3 program has also generated positive data in a well-established animal model of arthritis.

Zaltenibart (OMS906)

The lead product candidate in our MASP-3 inhibitor program is zaltenibart (previously referred to as OMS906), a proprietary, patented human monoclonal antibody targeting MASP-3.

Clinical development of zaltenibart is ongoing in PNH and C3G.

Zaltenibart has been well tolerated to date across all clinical trials, and no safety signal of concern has been identified.

Paroxysmal nocturnal hemoglobinuria ( “ PNH ” ):

Our program evaluating zaltenibart in PNH is in Phase 3 of development .

Similar to our Phase 2 program, our Phase 3 program includes both a study treating PNH patients who are not receiving treatment with a complement inhibitor, as well as a “switch-over” study in PNH patients who have had an unsatisfactory response to eculizumab and ravulizumab, both of which are inhibitors of complement component 5 (“C5”).

In the fall of 2024, we met with FDA and European regulators to discuss further details of our planned Phase 3 program for zaltenibart in PNH.

With both regulatory agencies, we discussed data developed from our clinical and nonclinical programs to date and our Phase 3 development plans for zaltenibart in PNH.

Both regulatory agencies agreed with the trial designs and provided other valuable feedback to inform our development plans.

Both studies in our Phase 3 program are designed to provide head-to-head comparisons with the C5 inhibitors and could produce data demonstrating the superiority of zaltenibart over the C5 inhibitors in these patient populations.

These data could form the basis for comparative superiority claims for promotion, enhanced market access, and pricing reflective of zaltenibart’s advantages.

We also sought and received recommendations regarding patient-reported-outcome measures from the German Federal Joint Committee, which determines availability of reimbursement from statutory health insurance funds in that country and which has specialized expertise in patient-reported-outcome measures.

Recommended patient-reported-outcome measures were incorporated into the zaltenibart Phase 3 program and are expected to be helpful in securing appropriate pricing in relevant jurisdictions.

Clinical site activation in our Phase 3 program for PNH has begun.

All zaltenibart drug product needed for our Phase 3 programs has been manufactured and active comparator drug has been sourced.

A total of 120 clinical investigative sites across 30 countries have been chosen for clinical trial participation in the zaltenibart Phase 3 program in PNH.

A number of these sites have already identified pools of PNH patients ready to participate in the zaltenibart trials, and Omeros continues collaborating with sites to identify additional eligible and already available PNH patients.

Our Phase 2 development program evaluating zaltenibart for PNH consists of three studies.

A study in PNH patients who have had an unsatisfactory response to the C5 inhibitor ravulizumab has been completed.

A study in PNH patients who have not previously been treated with a complement inhibitor is ongoing under protocol amendments intended to produce additional data on the zaltenibart dose selected for Phase 3 development.

The third clinical trial in our Phase 2 program evaluating zaltenibart in PNH is an ongoing open-label extension study to assess the long-term efficacy and safety of zaltenibart in patients who have completed any of our PNH clinical trials.

Data from the extension study are expected to contribute to any future marketing applications for zaltenibart in the treatment of PNH.

Results from a pre-specified interim analysis in our Phase 2 clinical trial of zaltenibart in complement-inhibitor-naïve adults with PNH were featured in a podium presentation at the annual meeting of the American Society of Hematology in December 2023.

The interim analysis results showed statistically significant and clinically meaningful improvements in all measured markers of hemolysis, including hemoglobin and lactate dehydrogenase.

This study was amended to gather additional data on the zaltenibart dose selected for Phase 3 development and remains ongoing for this purpose.

The last patient visit in our Phase 2 trial evaluating two doses of zaltenibart in PNH patients who have had an unsatisfactory response to the C5 inhibitor ravulizumab occurred in October 2024.

Utilizing a “switch-over” design, this study enrolled PNH patients receiving ravulizumab, added zaltenibart to provide combination therapy with ravulizumab for 24 weeks, and then, in those patients who demonstrated a hemoglobin response with the combination therapy, switched to zaltenibart monotherapy.

In June 2024, efficacy data from a pre-specified interim analysis of the combination therapy portion of the trial were featured in a podium presentation at the annual congress of the European Hematology Association held in Madrid, Spain.

The interim analysis showed that the addition of zaltenibart therapy to ravulizumab treatment resulted in statistically significant and clinically meaningful improvements in both mean hemoglobin levels and absolute reticulocyte counts by week 4 of combination therapy, with a sustained response observed through week 24 (the latest assessment prior to the interim analysis cutoff).

All 13 enrolled patients were included in the interim analysis.

All patients in the high-dose group achieved clinical response, defined as an increase in hemoglobin of at least 2 grams, and six of seven patients in the low-dose group achieved this same clinical response.

Data from the monotherapy portion of the trial were presented at the annual meeting of the American Society of Hematology in December 2024.

Twelve of 13 enrolled patients continued to the second stage of the study.

The interim results from the monotherapy stage of the study showed that in PNH patients experiencing substantial extravascular hemolysis while receiving ravulizumab, zaltenibart monotherapy resulted in sustained clinically meaningful improvements in both hemoglobin and absolute reticulocyte count and prevented both intravascular and extravascular hemolysis.

Zaltenibart received designation from FDA as an orphan drug for the treatment of PNH in July 2022.

Complement 3 glomerulopathy ( “ C3G ” ):

We also have an ongoing Phase 2 clinical program evaluating zaltenibart for the treatment of C3G, a rare and debilitating renal disease driven by complement dysregulation.

Notably, the relevance of the alternative pathway to C3G has been clinically validated in two Phase 3 trials with other inhibitors of the alternative pathway that reported positive results in the treatment of C3G.

Sites for the zaltenibart Phase 2 trial in C3G are open to enrollment in multiple countries and dosing in the study is ongoing.

We are amending the study to include a cohort of patients with C3G who have normal plasma C3 levels and evidence of renal inflammation in their urine, which represents a large proportion of the total C3G population.

Our Phase 2 study in C3G requires enrollment of a relatively small number of patients and we expect to complete the study later this year.

Following completion of the Phase 2 study, and assuming strong evidence of efficacy, we plan to initiate a Phase 3 trial in C3G.

In October 2024, zaltenibart received a rare pediatric disease designation from FDA for the treatment of C3G.

Companies awarded a rare pediatric disease designation are eligible to receive a rare pediatric disease priority review voucher from FDA if the designated drug's first approval is for the associated indication in the pediatric population and certain other criteria are met.

Absent legislative reauthorization and extension of the priority review voucher program for rare pediatric disease, one of the criteria for receipt of a voucher under the current law is that the drug must be approved by September 30, 2026.

The holder of a priority review voucher is entitled to obtain a priority review by FDA of either a new drug application or a biologics license application for a different product and/or indication, reducing the review time and accelerating any grant of approval and subsequent market entry by at least four months.

The voucher may be used by the original recipient, or it can be sold for use to another company.

As part of our program to develop complement-targeted therapeutics, we have identified MASP-3, which has been shown to be the key activator of the APC, and we believe that we are the first to make this and related discoveries associated with the APC.

On November 25, 2025, we completed the sale and transfer to Novo Nordisk of exclusive global rights in all indications to develop and commercialize our lead investigational MASP-3 inhibitor, zaltenibart (formerly OMS906), and certain related compounds and products.

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.

For more information, see “Our Partnered Program:

Zaltenibart (OMS906)” above.

Preclinical Complement Inhibitor Programs

We have also directed efforts to development of small-molecule inhibitors of MASP-2 and MASP-3 designed for oral administration.

In our MASP-2 small-molecule inhibitor program, we continue to develop and assess preclinical data on our selected drug candidate.

Our MASP-3 small-molecule inhibitor is advancing toward selection of a drug development candidate.

Other Clinical Programs

In our MASP-2 small-molecule inhibitor program, we are in the final stage of selecting a drug development candidate.

In our MASP-3 small-molecule inhibitor program, we are assessing molecules to select a drug development candidate.

Other Development Programs

PDE7 Inhibitor Programs - OMS527

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Data generated in preclinical studies support the use of PDE7 inhibitors in both of these therapeutic areas.

Cocaine Use Disorder ( “ CUD ” ):

In April 2023, we were awarded a grant from the National Institute on Drug Abuse (“NIDA”), part of the National Institutes of Health, and requested by NIDA to develop our lead orally administered PDE7 inhibitor compound for the treatment of CUD.

The award, for a total of $6.24 million over three years is intended to fund an in-patient, placebo-controlled clinical study evaluating the safety and effectiveness of OMS527 in adults with CUD who receive concurrent intravenous cocaine, as well as prerequisite cocaine-OMS527 interaction safety studies in which the OMS527 therapeutic candidate was co-administered with cocaine in two animal species to rule out enhancement of the detrimental effects of cocaine.

In the OMS527-cocaine interaction studies, OMS527, when administered at two different doses in combination with cocaine, did not produce an additive or synergistic effect on the convulsive threshold of cocaine in rats or on the adverse cocaine-induced cardiovascular responses in non-human primates.

Cocaine Use Disorder :

In April 2023, we were awarded a grant from NIDA, part of the National Institutes of Health, to develop, at NIDA’s request, our lead orally administered PDE7 inhibitor compound for the treatment of cocaine use disorder.

NIDA awarded the grant to us for a total of $6.24 million over three years, of which we have claimed and received $2.2 million of funding to date.

The grant is intended to support preclinical cocaine interaction/toxicology studies to assess safety of the therapeutic candidate in the presence of concomitant cocaine administration, as well as an in-patient, placebo-controlled clinical study evaluating the safety and efficacy of OMS527 in adult cocaine users who receive concurrent intravenous cocaine.

The preclinical studies, designed with NIDA toxicologists, were completed and showed no drug-interaction or safety issues, supporting the scheduled in-patient human study of OMS527 in cocaine users.

In these studies, the OMS527 therapeutic candidate was co-administered with cocaine in two animal species to rule out enhancement of the detrimental effects of cocaine.

OMS527, when administered at two different doses in combination with cocaine, did not produce an additive or synergistic effect on the convulsive threshold of cocaine in rats or on the adverse cocaine-induced cardiovascular responses in non-human primates.

Instead, the higher doses of OMS527 generally lessened the severity of effects noted following intravenous administration of cocaine, most notably decreasing convulsant-related activity following the administration of cocaine.

Based on the successful outcome of the preclinical studies, NIDA has provided the Company with a funding commitment for the year commencing April 1, 2025 in the amount of $4.02 million.

This amount is expected to fund the inpatient clinical trial assessing safety and efficacy of the lead OMS527 compound in adult patients with CUD.

Readout of preliminary data from that study is targeted by year-end 2025.

FDA subsequently requested additional preclinical information prior to initiating the clinical in-patient study in cocaine users.

Together with our collaborators at NIDA, we are scheduled to meet with FDA to discuss that request.

In a previously completed Phase 1 clinical trial in healthy human subjects the lead OMS527 compound was well tolerated with no safety signal of concern and displayed favorable pharmacokinetics, supporting once daily dosing in the dose range expected to produce efficacy in humans.

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More than 10 million patients are living with Parkinson’s disease worldwide.

Reportedly 50 percent or more of levodopa-treated patients with Parkinson’s disease suffer from LID.

Reportedly 50% or more of levodopa-treated patients with Parkinson’s disease suffer from LID.

We hold an exclusive license to certain PDE7 inhibitors claimed in patents and pending patent applications owned by Daiichi Sankyo Co., Ltd.

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For a more detailed description of our agreement with Daiichi Sankyo, see “License and Development Agreements” below.

PPAR γ Program - OMS405

In our peroxisome proliferator-activated receptor gamma (“PPARγ”) program, we have engaged in development of proprietary compositions that include PPARγ agonists for the treatment and prevention of addiction to substances of abuse, which may include opioids, nicotine and alcohol.

We believe that Omeros is the first to demonstrate a link between PPARγ and addiction disorders.

Data from clinical studies and from animal models of addiction suggest that PPARγ agonists could be efficacious in the treatment of a wide range of addictions.

Our collaborators at The New York State Psychiatric Institute have completed two Phase 2 clinical trials related to our PPARγ program.

These studies evaluated a PPARγ agonist, alone or in combination with other agents, for treatment of addiction to heroin and to nicotine.

The published results of the heroin study demonstrated that, although not altering the reinforcing or positive subjective effects of heroin, the PPARγ agonist significantly reduced heroin craving and overall anxiety.

NIDA provided substantially all of the funding for these clinical trials and solely oversaw the conduct of these trials.

We have the right or expect to be able to reference the data obtained from these studies for any future FDA submission and continue to retain all other rights in connection with the PPARγ program.

We have also reported positive results ( i.e.

, decreased cravings and protection of brain white matter) from a Phase 2 clinical trial conducted by an independent investigator evaluating the effects of a PPARγ agonist in patients with cocaine use disorder.

An investigator-sponsored study evaluating the effects of a PPARγ agonist on the prevention of relapse following treatment of cocaine use disorder is ongoing.

The study is funded by NIDA.

We own patents, patent applications and other intellectual property rights related to our PPARγ program, as described under “Intellectual Property” below.

Preclinical Programs and Platforms

Oncology Platform

The objective of our oncology program is to move beyond existing targeted biologics, such as antibody-drug conjugates (“ADC”), which have small therapeutic indexes and limited tissue penetrance, and beyond engineered cellular-therapies, such as CAR-T cells, which are expensive and time-consuming.

Building on our understanding of immunity, both innate, e.g., complement-mediated, and adaptive, meaning B-cells as well as CD4 and CD8 T-cells, we are developing a portfolio of next generation biologics to treat cancer.

It consists of new modalities of targeted drug conjugates, with better therapeutic indexes and better tissue penetrance, which we believe could eventually sideline the current ADC technology.

Our portfolio also includes an adoptive T-cell technology combined with an immunostimulator that is easier, faster and cheaper than current cellular therapy approaches.

Our technology also maintains an enhanced anti-cancer immune response through subsequent repetitive and simple therapeutic administrations.

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.

Sales and Marketing

We have retained all worldwide marketing and distribution rights to our product candidates and our development programs.

As such, we will be able to market any product candidate that is approved in the future independently, through arrangements with third parties, or via some combination of these approaches.

If narsoplimab is approved for marketing in the United States for treatment of TA-TMA, we expect to utilize an internal sales force to sell the product.

We have hired a head of sales for narsoplimab, along with regional leaders of our planned U.S.

sales force and intend to begin hiring specialty sales representatives for U.S.

field sales upon reaching certain milestones associated with FDA’s review of our BLA for narsoplimab.

If our anticipated MAA for narsoplimab in TA-TMA is approved by the EMA, we intend to enter into partnerships and/or commercial services arrangements with third-parties to market and sell narsoplimab in Europe and are currently evaluating various potential arrangements for commercialization in Europe.

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.

Acute myeloid leukemia (“AML”), an aggressive and highly fatal bone marrow and blood cancer, is the lead indication for development in this program.

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.

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.

In preclinical models both in vivo – in immunocompromised mice with human tumors – and in vitro , our AML therapeutic candidate has consistently demonstrated superior efficacy to current AML standard of care treatments and has been well-tolerated in preliminary, preclinical tolerability studies.

In February 2026, we announced the successful completion of our initial study in nonhuman primates evaluating the efficacy and safety of OncotoX-AML.

Administration of only one course of OncotoX-AML treatment to immunocompetent primates demonstrated the desired pharmacologic response, specifically marked, selective, reversible, and dose-related reduction in myeloid progenitor cells — the cells that can mutate and lead to AML — by up to 99%.

OncotoX-AML was well tolerated.

There were no observed safety signals or meaningful changes in blood chemistry values often seen with current AML treatments.

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.

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

We continue to confirm our results and to generate new data, which we expect will contribute to our intellectual property position.

T-CAT - Infectious Disease

We are also advancing our Targeted Complement Activating Therapy (“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.

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.

In well-established in vivo animal models considered predictive of efficacy in humans, T-CAT recombinant antibodies demonstrated effectiveness in treating life-threatening infections caused by Gram-negative and Gram-positive bacteria, including those designated by the World Health Organization as priority pathogens.

Patent applications broadly covering this new technology platform have been filed.

Sales, Marketing, and Access

We have retained all worldwide marketing and distribution rights to YARTEMLEA, our product candidates, and our development programs.

This allows us to market and sell YARTEMLEA and any product candidate that is approved in the future independently, through arrangements with third parties, or via some combination of these approaches.

We are commercializing YARTEMLEA in the U.S.

market and have deployed a field force of account managers and directors, market development managers, access leads, and medical science liaisons to engage directly with transplant centers across the United States.

Commercial distribution and sales of YARTEMLEA commenced in January 2026.

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, 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 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 payers.

There are 175 stem-cell transplant centers across the U.S., with the top 80 centers representing approximately 80% of procedures.

We are initially prioritizing centers with the greatest transplant volume and established TA-TMA expertise.

Additionally, under the YARTEMLEAssist™ patient support program, we expect to offer options for eligible patients who are uninsured, or who have health insurance but cannot afford the out-of-pocket costs required under their plans.

For commercialization of YARTEMLEA outside the U.S., we are evaluating potential partnerships, both broad ex-U.S.

arrangements and regional collaborations.

Manufacturing, Supply, and Commercial Operations

We have laboratories in-house for analytical method development, bioanalytical testing, formulation, stability testing and small-scale compounding of laboratory supplies of product candidates;

however, we do not own or operate internal manufacturing facilities capable of producing sufficient quantities of our product candidates under current Good Manufacturing Practices (“cGMP”) for use in clinical studies, or for the manufacture of narsoplimab for commercial use following potential regulatory approval.

We utilize contract manufacturers to produce sufficient quantities of product candidates for use in preclinical and clinical studies and to store and distribute our product candidates.

We require manufacturers that produce bulk drug substance and finished drug products for clinical use to operate in accordance with cGMP and all other applicable laws and regulations.

We anticipate that we will rely on contract manufacturers to develop and manufacture our product candidates for commercial sale.

We maintain agreements with potential and existing manufacturers that include confidentiality and intellectual property provisions to protect our proprietary rights related to our product candidates.

We have laboratories in-house for analytical method development, bioanalytical testing, formulation, non-GMP stability testing, and small-scale compounding of laboratory supplies of product candidates;

In July 2019, we entered into a master services agreement with Lonza Biologics Tuas Pte.

(“Lonza”) for the commercial production of narsoplimab and for certain regulatory support and related services to be provided by Lonza from time to time.

Under the agreement Lonza will manufacture narsoplimab pursuant to purchase orders issued in accordance with certain forecast and confirmation procedures specified in the contract.

We will purchase narsoplimab that meets agreed specifications in batches, with the price per batch varying according to the total number of batches ordered for serial production in a single manufacturing campaign.

We are obligated to purchase a minimum number of batches annually beginning on a specified anniversary of the first commercial sale of narsoplimab in either the U.S.

(“Lonza”) for the commercial production of YARTEMLEA and for certain regulatory support and related services to be provided by Lonza from time to time.

Under the agreement Lonza manufactures YARTEMLEA pursuant to purchase orders issued in accordance with certain forecast and confirmation procedures specified in the contract.

We purchase YARTEMLEA that meets agreed specifications in batches, with the price per batch varying according to the total number of batches ordered for serial production in a single manufacturing campaign.

We are obligated to purchase a minimum number of batches annually beginning on a specified anniversary of the first commercial sale of YARTEMLEA in either the U.S.

We may be obligated to pay certain fees to Lonza upon cancellation of purchase orders.

The initial term of the agreement expires five years after the first commercial sale of narsoplimab in either the U.S.

The initial term of the agreement expires five years after the first commercial sale of YARTEMLEA in either the U.S.

or EU and is subject to automatic renewal for an additional four-year term unless we provide notice of non-renewal at least three years prior to the end of the initial term.

In addition, either party may terminate the agreement, subject to applicable notice and cure periods under certain circumstances.

We have a Combined Development and Commercial Supply Agreement, effective May 16, 2018, with Vetter Pharma International, GmbH (“Vetter”) under which the process for manufacturing of sterile liquid vials pre-filled with finished narsoplimab was developed and validated, and pursuant to which Vetter has agreed to aseptically fill narsoplimab in vials for clinical or commercial use.

Under the agreement, we must provide Vetter with non-binding rolling forecasts of our long-term supply requirements on a periodic basis and submit purchase orders for filled narsoplimab vials intended for commercial use for confirmation by Vetter within an agreed time before the anticipated delivery date.

We have a Combined Development and Commercial Supply Agreement, effective May 16, 2018, with Vetter Pharma International, GmbH (“Vetter”) under which the process for manufacturing of sterile liquid vials pre-filled with finished YARTEMLEA was developed and validated, and pursuant to which Vetter has agreed to aseptically fill YARTEMLEA in vials for clinical or commercial use.

Under the agreement, we must provide Vetter with non-binding rolling forecasts of our long-term supply requirements on a periodic basis and submit purchase orders for YARTEMLEA batches intended for commercial use for confirmation by Vetter within an agreed time before the anticipated delivery date.

Pricing for commercial manufacturing services varies based on the number of batches ordered and may be adjusted periodically, subject to limitations specified in the agreement.

For commercial-stage manufacturing, each batch ordered must be for a quantity of finished units that is at least equal to a specified minimum but no more than a specified maximum per batch.

For commercial-stage manufacturing, each batch ordered must be for a quantity of finished sterile vials that is at least equal to a specified minimum but no more than a specified maximum per batch.

We may be obligated to pay certain fees to Vetter upon cancellation purchase orders or in connection with postponement of batches subject to a purchase order.

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In addition, either party may terminate the agreement under certain circumstances, subject to applicable notice and cure periods.

In addition to our agreements with Lonza and Vetter, we utilize a third-party vendor for labelling and final packaging of narsoplimab finished goods.

We expect to utilize one or more wholesalers for distribution of narsoplimab, if approved in the U.S.

for commercial sale.

We have not entered into commercial supply agreements for any of our product candidates other than narsoplimab.

In addition to our agreements with Lonza and Vetter, we utilize a third-party vendor for labelling and final packaging of YARTEMELA finished goods.

We have not entered into commercial supply agreements for any of our product candidates other than YARTEMLEA.

Zaltenibart .

Under the Transition Services Agreement, we are transitioning to Novo Nordisk certain agreements and relationships with third parties that manufacture, store, and distribute zaltenibart for use in preclinical and clinical studies.

Product Candidates .

We utilize contract manufacturers to produce sufficient quantities of product candidates for use in preclinical and clinical studies and to store and distribute our product candidates.

We require manufacturers that produce bulk drug substance and finished drug products for clinical use to operate in accordance with cGMP and all other applicable laws and regulations.

We anticipate that we will rely on contract manufacturers to develop and manufacture our product candidates for commercial sale.

We maintain agreements with potential and existing manufacturers that include confidentiality and intellectual property provisions to protect our proprietary rights related to our product candidates.

License and Development Agreements

In August 2020, we entered into a technology license agreement with Xencor, Inc., pursuant to which we received an exclusive license to apply Xencor’s Xtend Fc technology to zaltenibart and options to access exclusive licenses to apply Xtend Fc technology to additional antibodies (the “Xencor Agreement”).

Exercise of an option to access additional licenses would require payment of a $3.0 million upfront license fee.

With respect to each antibody for which we license the Xencor technology we are obligated to make milestone payments of up to $65.0 million, comprised of $15.0 million in development milestones, $25.0 million in regulatory milestones and $25.0 million in sales milestones.

In August 2023, we paid $5.0 million to Xencor in connection with the achievement of a development milestone in our zaltenibart program.

We expect that an additional $10.0 million milestone payment will become due during 2025, pending the anticipated achievement later this year of an additional clinical development milestone in our zaltenibart program.

We are obligated on a product-by-product and country-by-country basis to pay Xencor royalties in the mid-single digit percentage range on net sales of any product covered by the license so long as there is a valid, subsisting and enforceable claim in any patents or patent applications covering the licensed technology.

Thereafter, the royalty rate is reduced to the low single-digit percentage range, if the applicable licensed product is covered by Xencor know-how, or to zero, if the applicable licensed product is not covered by Xencor know-how.

The term of the Xencor Agreement continues on a product-by-product basis until the later of (i) expiration for the last-to-expire patent covering the licensed technology or (ii) five years from the date of first commercial sale of the applicable product.

Novo Nordisk .

Concurrent with the closing of the Transaction, Novo Nordisk granted to us exclusive, worldwide, royalty-free, transferrable (solely in connection with a permitted assignment of the APLA), sublicensable (in accordance with the APLA), perpetual and irrevocable (except as set forth in the APLA) licenses under certain technology that we licensed or assigned to Novo Nordisk pursuant to the APLA.

This license, along with certain retained intellectual property rights, enables us to exploit certain grandfathered MASP-3 products and compounds directed to certain indications as permitted under the APLA.

Under an agreement with Daiichi Sankyo, we hold an exclusive worldwide license to PDE7 inhibitors claimed in certain patents and pending patent applications owned by Daiichi Sankyo for use in the treatment of (1) movement disorders and other specified indications, (2) addiction and compulsive disorders and (3) all other diseases except those related to dermatologic conditions.

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● take advantage of acquisition or other opportunities more readily than we can.

We expect to compete for market share against large pharmaceutical and biotechnology companies, smaller companies that are collaborating with larger pharmaceutical companies, new companies, academic institutions, government agencies and other public and private research organizations.

In addition, the pharmaceutical and biotechnology industry is characterized by rapid technological change.

Because our research approach integrates many technologies, it may be difficult for us to remain current with the rapid changes in each technology.

Further, our competitors may render our technologies obsolete by advancing their existing technological approaches or developing new or different approaches.

If we fail to stay at the forefront of technological change, we may be unable to compete effectively.

Product Candidates, Development Programs and Platforms.

There are a number of complement-targeted therapeutics that are in advanced stages of clinical development, or which have been approved for commercial use.

These include Soliris® (eculizumab), Ultomiris® (ravulizumab-cwvz), Empaveli® (pegcetacoplan), Tavneos® (avocopan), PiaSky® (crovalimab-akkz), Voydeya (danicopan) and Fabhalta® (iptacopan).

Narsoplimab, OMS1029 and/or zaltenibart will face competition from branded and/or generic versions of one or more of these products if approved for any indication(s) for which one or more of these potentially competitive products are also approved or for which a potentially competitive product is used off-label to treat a relevant condition.

YARTEMLEA is currently the only approved treatment for TA-TMA.

However, a number of complement-targeted therapeutics that have historically been used off-label to treat TA-TMA patients, including the C5 inhibitors Soliris ® (eculizumab) and Ultomiris ® (ravulizumab-cwvz), and YARTEMLEA may face competition from continued off-label use of these products.

A Phase 3 clinical trial of ravulizumab in pediatric TA-TMA patients did not meet its pre-specified primary endpoint.

Additionally, we understand that a Phase 3 clinical trial of ravulizumab in adult patients with TA-TMA has been completed, although trial results have not been announced.

YARTEMLEA would face increased competition in the market for TA-TMA therapies if ravulizumab or any other product is approved for treatment of TA-TMA.

In addition to Soliris and Ultomiris, there are a number of other therapeutics that are either on the market or are in advanced stages of clinical development, including Empaveli ® (pegcetacoplan), Tavneos ® (avocopan), PiaSky ® (crovalimab-akkz), Voydeya (danicopan) and Fabhalta ® (iptacopan).

YARTEMLEA, OMS1029 and any of our other complement-targeting development candidates may face competition from branded, generic, and/or biosimilar versions of one or more of these products if approved for any indication(s) for which one or more of these potentially competitive products are also approved or for which a potentially competitive product is used off-label to treat a relevant condition.

Intellectual Property

We have retained control of all worldwide manufacturing, marketing and distribution rights for each of our product candidates and programs.

We have retained control of all worldwide manufacturing, marketing, and distribution rights for YARTEMLEA and each of our product candidates and programs, with the exception of our MASP-3 inhibitor program following the sale and license to Novo Nordisk of assets and development rights related to zaltenibart and certain related compounds and products.

Some of our product candidates and programs are based on inventions and other intellectual property rights that we acquired through assignments, exclusive licenses, or acquisitions described in further detail under “License and Development Agreements” above.

As of March 31, 2025, we owned or held worldwide exclusive licenses to a total of 81 issued patents and 64 pending patent applications in the U.S.

and 1,443 issued patents and 655 pending patent applications in foreign markets directed to therapeutic compositions and methods and other technologies related to our research and development programs.

We own or hold worldwide exclusive licenses to issued patents and pending patent applications in the U.S.

and foreign markets directed to therapeutic compositions and methods and other technologies related to YARTEMLEA and our research and development programs.

For each program, our decision to seek patent protection in specific foreign markets, in addition to the U.S., is based on many factors, including one or more of the following:

our available resources, the size of the commercial market, the presence of a potential competitor or a contract manufacturer in the market and whether the legal authorities in the market effectively enforce patent rights.

● MASP-2 Program - Narsoplimab (OMS721) and OMS1029.

Unless otherwise noted, our patents generally have the same term in the U.S.

● MASP-2 Program – YARTEMLEA (narsoplimab-wuug) (OMS721) and OMS1029.

We own and hold worldwide exclusive licenses to rights in connection with MASP-2, antibodies targeting MASP-2, small-molecule MASP-2 inhibitors, and related therapeutic applications.

As of March 31, 2025, we exclusively controlled 42 issued patents and 33 pending patent applications in the U.S., and 861 issued patents and 474 pending patent applications in foreign markets, related to our MASP-2 program, including narsoplimab and our second-generation MASP-2 antibody OMS1029.

Our MASP-2-related patents have terms that will expire as late as 2038 and, if currently pending patent applications are issued, as late as 2043.

● MASP-3 Program - Zaltenibart (OMS906) .

We own and exclusively control rights in connection with MASP-3, antibodies targeting MASP-3 and related therapeutic applications.

We also hold an exclusive license from Xencor, Inc.

for the application of certain antibody technology to zaltenibart, as well as the option to obtain additional licenses to such technology for exclusive application to additional antibodies that we may select.

As of March 31, 2025, we exclusively controlled five issued patents and eight pending patent applications in the U.S.

and 212 issued and 109 pending patent applications in foreign markets that are related to our MASP-3 program.

Our MASP-3-related patents have terms that will expire as late as 2037 and, if currently pending patent applications are issued, as late as 2043.

● PPAR γ Program - OMS405 .

As of March 31, 2025, we owned three issued patents and one pending patent application in the U.S., and 42 issued patents and one pending patent application in foreign markets, directed to our discoveries linking PPARγ and addictive disorders.

Our PPARγ-related patents have terms that will expire as late as 2030.

Within our MASP-2 program, our YARTEMLEA-related patents have terms that will expire as late as 2037 and, if currently pending patent applications are issued, as late as 2042.

Other patents within our MASP-2 program have terms that will expire as late as 2042.

● MASP-3 Program.

Pursuant to the APLA, Novo Nordisk received exclusive global rights in all indications to develop and commercialize zaltenibart (OMS906), and certain related compounds and products.

We retained certain patent applications in connection with our grandfathered MASP-3 program unrelated to zaltenibart, and, if the currently pending patent applications are issued, they will have terms that expire as late as 2046.

Further, we hold certain licenses from Novo Nordisk in connection with our grandfathered MASP-3 program unrelated to zaltenibart.

For more information regarding these licenses, see “License and Development Agreements.”

● PDE7 Program – OMS527 .

As of March 31, 2025, we owned two issued patents and two pending patent applications in the U.S., and 61 issued patents and seven pending patent applications in foreign markets directed to our discoveries linking PDE7 to movement disorders, as well as three issued patents and two pending patent applications in the U.S., and 54 issued patents and six pending patent applications in foreign markets directed to the link between PDE7 and addiction and compulsive disorders.

Additionally, under a license from Daiichi Sankyo, we exclusively control rights to two issued U.S.

patents and 53 issued patents in foreign markets that are directed to proprietary PDE7 inhibitors.

Our PDE7-related patents have terms that will expire as late as 2031 and, if currently pending patent applications are issued, as late as 2043.

Our PDE7-related patents have terms that will expire as late as 2031 in the U.S.

and 2033 in Europe and, if currently pending patent applications are issued, as late as 2044 in both the U.S.

Additionally, we hold certain licenses from Daiichi Sankyo.

For a more detailed description of our agreement with Daiichi Sankyo, see “License and Development Agreements” above.

● Oncology Program.

Our oncology program comprises novel platforms and technologies related to potential therapies for cancer.

We are operating the oncology program 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.

As of March 31, 2025, we had two patent applications pending in the U.S.

directed to a potential cancer therapeutic derived from our oncology platform.

Our oncology-related patent applications have terms that will expire as late as 2046, if currently pending patent applications are issued.

● T-CAT Program.

Our T-CAT-related patents have terms that will expire as late as 2042 and, if currently pending patent applications are issued, as late as 2046.

All of our employees enter into our standard employee proprietary information and inventions agreement, which includes confidentiality provisions and provides us ownership of all inventions and other intellectual property made by our employees that pertain to our business or that relate to our employees’ work for us or that result from the use of our resources.

Our commercial success will depend in part on obtaining and maintaining patent protection and trade secret protection of the use, formulation and structure of our product candidates and the methods used to manufacture them, as well as on our ability to defend successfully these patents against third-party challenges.

Our ability to protect our product candidates from unauthorized making, using, selling, offering to sell or importing by third parties is dependent on the extent to which we have rights under valid and enforceable patents that cover these activities.

Our commercial success will depend in part on obtaining and maintaining patent protection and trade secret protection of the use, formulation and structure of our product, product candidates and the methods used to manufacture them, as well as on our ability to defend successfully these patents against third-party challenges.

Our ability to protect our product and product candidates from unauthorized making, using, selling, offering to sell or importing by third parties is dependent on the extent to which we have rights under valid and enforceable patents that cover these activities.

The patent positions of pharmaceutical, biotechnology and other life sciences companies can be highly uncertain and involve complex legal and factual questions for which important legal principles remain unresolved.

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Patent and Trademark Office (“USPTO”) and various foreign jurisdictions in connection with the products and services we offer.

We also have registered and pending trademark applications within the USPTO and in certain foreign jurisdictions directed to the trademark “YARTEMLEA”, the brand name under which we expect to market narsoplimab if the drug is approved for commercial sale.

We also have registered, and intend to maintain, the trademark “YARTEMLEA”, the brand name under which we market narsoplimab for commercial sale, within the USPTO and certain foreign jurisdictions.

We are not aware of any material claims of infringement or other challenges to our right to use our trademarks in the U.S.

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Government Regulation

Government authorities in the U.S., the EU and other countries extensively regulate the research, development, testing, manufacture, labeling, promotion, advertising, distribution, marketing, and export and import of drug and biologic products including the product candidates that we are developing.

Government authorities in the U.S., the European Union (the “EU”) and other countries extensively regulate the research, development, testing, manufacture, labeling, promotion, advertising, distribution, marketing, and export and import of drug and biologic products including YARTEMLEA and the product candidates that we are developing.

Failure to comply with applicable requirements, both before and after receipt of regulatory approval, may subject us, our third-party manufacturers, and other partners to administrative and judicial sanctions, such as warning letters, product recalls, product seizures, a delay in approving or refusal to approve pending applications, civil and other monetary penalties, total or partial suspension of production or distribution, injunctions, and/or criminal prosecutions.

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In the EU, our product candidates are regulated by the EMA and national medicines regulators under the rules governing medicinal products in the EU as well as national regulations in individual countries.

YARTEMLEA has received marketing approval from the FDA and is under review by EMA in the EU.

Our product candidates are in various stages of testing and none of our product candidates has received marketing approval from FDA or the applicable regulatory authorities in the EU.

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● preclinical laboratory and animal testing;

● submission to FDA of an Investigational New Drug application (“IND”) for human clinical testing, which must become effective before human clinical trials may begin;

● submission to FDA of an IND for human clinical testing, which must become effective before human clinical trials may begin;

in the EU Member States and in European Economic Area countries a Clinical Trial Application (“CTA”) is submitted to the Clinical Trials Information System;

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● Phase 1 usually involves the initial administration of the investigational product to human subjects, who may or may not have the disease or condition for which the product is being developed, to evaluate the safety, dosage tolerance, pharmacodynamics and, if possible, to gain an early indication of the effectiveness of the product.

● Phase 2 usually involves trials in a limited patient population with the disease or condition for which the product is being developed to evaluate appropriate dosage, to identify possible adverse side effects and safety risks, and to evaluate preliminarily the effectiveness of the product for specific indications.

● Phase 2 usually involves trials in a limited patient population with the disease or condition for which the product is being developed to evaluate appropriate dosage, to identify possible adverse side effects and safety risks, and to evaluate the effectiveness of the product for specific indications.

● Phase 3 clinical trials usually further evaluate and confirm effectiveness and test further for safety by administering the product in its final form in an expanded patient population.

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The testing and approval process requires substantial time, effort, and financial resources, and we cannot be sure that any future approval will be granted on a timely basis, if at all.

Some of our product candidates, such as those from our MASP-2 and MASP-3 programs, are considered biologics because they are proteins that are greater than 40 amino acids in size.

Some of our product candidates, such as those from our MASP-2, MASP-3, OncotoX-AML, and T-CAT programs, are considered biologics because they are proteins that are greater than 40 amino acids in size.

The added complexity associated with manufacturing biologics may result in additional monitoring of the manufacturing process and product changes.

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For example, we must establish a pharmacovigilance system and are required to report adverse reactions and production problems, if any, to the regulatory authorities.

If any of our product candidates are approved, we will be required to also comply with certain requirements concerning advertising and promotion for our products.

The regulatory authorities may impose specific obligations as a condition of the marketing authorization, such as additional safety monitoring, or the conduct of additional clinical trials or post-marketing safety studies, or the imposition of a Risk Evaluation and Mitigation Strategy (“REMS”), which could include significant restrictions on distribution or use of the product.

We must also comply with certain requirements concerning advertising and promotion for our products.

The regulatory authorities may impose specific obligations as a condition of the marketing authorization, such as additional safety monitoring, or the conduct of additional clinical trials or post-marketing safety studies, or the imposition of a REMS, which could include significant restrictions on distribution or use of the product.

Also, quality control and manufacturing procedures must continue to conform to cGMP after approval.

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For products and transactions falling within DSCSA’s scope, manufacturers are required to verify that purchasers of the manufacturers’ products are appropriately licensed.

Further, under the DSCSA, covered manufacturers have drug product investigation, quarantine, disposition, and notification responsibilities for product that is reasonably believed or that credible evidence shows to be counterfeit, diverted, stolen, intentionally adulterated such that the product would result in serious adverse health consequences or death, the subject of fraudulent transactions or otherwise unfit for distribution such that they would be reasonably likely to result in serious health consequences or death.

Further, under the DSCSA, covered manufacturers have drug product investigation, quarantine, disposition, and notification responsibilities for product that is reasonably believed or that credible evidence shows to be counterfeit, diverted, stolen, intentionally adulterated such that the product would result in serious adverse health consequences or death, be the subject of fraudulent transactions or be otherwise unfit for distribution such that they would be reasonably likely to result in serious health consequences or death.

Anti-counterfeiting and serialization requirements similar to those under the DSCSA have also been adopted in the EU and became effective in February 2019.

Foreign Regulatory Requirements.

Outside of the U.S., our ability to conduct clinical trials or market our products will also depend on receiving the requisite authorizations from the appropriate regulatory authorities.

Outside the U.S., our ability to conduct clinical trials or market our products will also depend on receiving the requisite authorizations from the appropriate regulatory authorities.

The foreign regulatory approval processes include similar requirements and many of the risks associated with FDA and/or the EU approval process described above, although the precise requirements may vary from country to country.

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Healthcare compliance laws .

In the U.S., commercialization of our product candidates, if approved, is subject to regulation and enforcement under a number of federal and state healthcare compliance laws administered and enforced by various agencies.

In the U.S., commercialization of YARTEMLEA and our product candidates, if approved, is subject to regulation and enforcement under a number of federal and state healthcare compliance laws administered and enforced by various agencies.

These include, but are not limited to, the following:

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● the federal False Claims Act, which prohibits presenting or causing to be presented a false claim for payment by a federal healthcare program, and which has been interpreted to also include claims caused by improper drug-manufacturer product promotion or the payment of kickbacks;

● a variety of governmental pricing, price reporting, and rebate requirements, including those under Medicaid and the Veterans Health Care Act;

● a variety of governmental pricing, price reporting, and rebate requirements, including those under Medicaid, Medicare, and the Veterans Health Care Act;

● the so-called Sunshine Act and certain provisions of the Affordable Care Act, which require that we report to the federal government information on certain financial payments and other transfers of value made to certain health care providers and institutions, as well as certain information regarding our distribution of drug samples.

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Pharmaceutical Pricing and Reimbursement

and foreign markets, our ability to commercialize our product candidates successfully, and to attract commercialization partners for our product candidates, depends in significant part on the availability of adequate financial coverage and reimbursement from third-party payers including, in the U.S., managed care organizations and other private health insurers as well as governmental payers such as the Medicare and Medicaid programs.

and foreign markets, our ability to commercialize YARTEMLEA and any of our product candidates that are approved successfully, and to attract commercialization partners for YARTEMLEA and our product candidates, if approved, depends in significant part on the availability of coverage and adequate financial reimbursement from third-party payers including, in the U.S., managed care organizations and other private health insurers as well as governmental payers such as the Medicare and Medicaid programs.

Reimbursement by a third-party payer may depend on a number of factors, including the payer’s determination that use of a product is:

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We may need to conduct expensive pharmacoeconomic studies in order to demonstrate the cost effectiveness of our products or product candidates.

Even with the availability of such studies, third-party private and/or governmental payers may not provide coverage and reimbursement for our product candidates, in whole or in part.

Even with the availability of such studies, third-party private and/or governmental payers may not provide coverage and adequate financial reimbursement for our products or product candidates, in whole or in part.

United States.

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There have been, and we expect there will continue to be legislative and regulatory proposals to change the healthcare system in ways that could significantly affect our business.

For example, legislation imposed a two percent across-the-board reduction to Medicare payments to providers, effective April 1, 2013, which, due to subsequent legislative amendments, will begin to increase gradually starting in April 2030, reaching 4 percent in April 2031 and continuing until the reduction ends in October 2031, unless additional congressional action is taken.

For example, legislation imposed a two percent across-the-board reduction to Medicare payments to providers, effective April 1, 2013, which, due to subsequent legislative amendments, will begin to increase gradually starting in April 2030, reaching four percent in April 2031 and continuing until the reduction ends in October 2031, unless additional congressional action is taken.

The American Taxpayer Relief Act of 2012, among other things, reduced Medicare payments to several providers, and increased the period for the government to recover overpayments to providers from three to five years.

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As of December 31, 2025, we had 175 full-time employees, 116 of whom are in research and development, 15 of whom are in sales and marketing and 44 of whom are in finance, legal, business development and administration.

Our full-time employees include seven with M.Ds and 41 with Ph.Ds., of whom six and 40, respectively, are in research and development.

Our full-time employees include five with M.D.s and 39 with Ph.D.s., of whom four and 38, respectively, are in research and development.

None of our employees are represented by a labor union, and we consider our employee relations to be good.

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In her career, Dr.

Dimitrova contributed to the development of a number of monoclonal antibodies, Fc-fusion proteins, PEG-proteins, bispecific molecules, cytokines, DNA, peptides, and small molecules at Amgen Inc., MedImmune (Astra Zeneca), Biogen, and Jazz Pharmaceuticals.

Dimitrova contributed to the commercialization of nine patient-convenient drug/device combination products for the treatment of autoimmune, respiratory, neurodegenerative, hematology, and infectious diseases.

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Earlier in his career, Dr.

Grauer was at Proctor and Gamble Pharmaceuticals where he held roles as global executive medical director for bone and for new technology development.

Grauer was at Proctor & Gamble Pharmaceuticals where he held roles as global executive medical director for bone and for new technology development.

Grauer received his M.D.

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From 2013 to 2016, Mr.

Williams served as the vice president, HR operations at Outerwall Inc.

Williams served as the vice president, human resources operations at Outerwall Inc.

(Coinstar) and before that he held human resources leadership roles at Coinstar from 2009 to 2013.

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What changed 10-K

Item 1. Business