What changed in this filing

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Item 1. Business

2025-03-31 compared with 2024-04-01 · 263 added, 220 removed, 547 unchanged (47% of the section changed)

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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 candidate in our lectin pathway program, is a proprietary, patented human monoclonal antibody inhibitor of MASP-2, the key effector enzyme of the lectin pathway.

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, a long-acting, next-generation antibody and an orally administered small molecule targeting MASP-2 and the lectin pathway.

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

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

We believe OMS906 has the potential to treat a wide range of alternative pathway-related diseases and that its attributes favorably differentiate OMS906 from other marketed and in-development alternative pathway inhibitors.

Clinical development of OMS906 is currently ongoing in multiple alternative pathway-related disorders, including complement 3 glomerulopathy (“C3G”), a rare chronic kidney disease, and paroxysmal nocturnal hemoglobinuria (“PNH”), a rare and life-threatening hemolytic blood disorder.

An orally administered small molecule MASP-3 inhibitor is also in development.

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 five immuno-oncology platforms directed to development of novel adoptive T cell/CAR-T therapies, immunomodulators, immunotoxins and cancer vaccines.

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

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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 and certain related assets, including inventory and prepaid expenses to Rayner Surgical Inc.

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 in cash at the closing and we retained all outstanding accounts receivable, accounts payable, and accrued expenses as of the closing date.

Rayner is also obligated under the Asset Purchase Agreement to pay us royalties 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 latest expiration of a patent covering OMIDRIA in the United States is currently in 2035.

Also pursuant to the Asset Purchase Agreement, we were entitled to receive a milestone payment of $200.0 million (the “Milestone Payment”) within 30 days following an event (the “Milestone Event”) that establishes separate payment for OMIDRIA for a continuous period of at least four years when furnished in the ambulatory surgery center (“ASC”) setting.

The Milestone Event occurred in December 2022 and we recorded a $200.0 million milestone receivable.

We received the Milestone Payment together with accrued interest in February 2023.

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 cash in exchange for a portion of our royalties on global net sales of OMIDRIA payable by Rayner between September 1, 2022 and December 31, 2030, subject to certain annual caps on the royalty amounts payable to DRI, with Omeros entitled to receive all royalties paid in excess of the applicable caps.

On February 1, 2024, we entered into an amended and restated royalty purchase agreement (the “Amendment”) with DRI to effect the sale to DRI of 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 now receive all royalties on U.S.

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 in cash 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.

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 its interest in the OMIDRIA royalties.

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.

As discussed above, the term for royalty payments under the Asset Purchase Agreement expires based on the last-expiring OMIDRIA-related patent in the relevant country, which in the United States currently extends into 2035.

The royalty rate payable by Rayner on net sales of OMIDRIA is currently 30% in the United States and 15% outside the U.S.

These royalty rates are subject to reduction upon the occurrence of certain events described in the Asset Purchase Agreement.

For example, the applicable U.S.

royalty rate would be reduced to 10% during any specific period in which OMIDRIA is no longer eligible for separate payment (i.e., included in the packaged payment rate for the surgical procedure) under Medicare Part B.

Pursuant to legislation enacted in late 2022, we expect separate payment for OMIDRIA under Medicare Part B to extend until at least January 1, 2028.

Our Drug Candidates and Development Programs

Our clinical drug candidates consist of the following:

Drug Candidate/Program

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 Product Candidates and Development Programs

Our clinical product candidates consist of the following:

Product Candidate/Program

Targeted Disease(s)

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

Pivotal trial complete;

CRL received;

working with FDA on BLA resubmission

BLA resubmission

Resubmission of BLA completed

FDA review of BLA;

submission of MAA to EMA

Narsoplimab (MASP-2 / Lectin Pathway)

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Phase 2 trial in severe COVID-19 completed

Continue development of narsoplimab and diagnostic for lectin pathway hyperactivation for COVID-19/ARDS and related indications

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

OMS1029 (MASP-2 / Lectin Pathway)

Long-acting second-generation antibody targeting lectin pathway disorders

Phase 1 trial nearly complete (dosing completed and follow-up ongoing)

Phase 1 studies completed

Select indication for Phase 2 development

OMS906 (MASP-3 / Alternative Pathway)

Paroxysmal nocturnal hemoglobinuria (PNH), complement 3 glomerulopathy (C3G) and other alternative pathway disorders

Complete Phase 2 trials with treated patients moving to extension study of long-term efficacy and finalize dose selections;

Initiate pivotal Phase 3 clinical trials.

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

OMS527 (PDE7)

Addictions and compulsive disorders;

Continue NIDA-funded research through completion of a Phase 1 cocaine interaction study and Phase 2 clinical trial in patients with cocaine use disorder;

Determine whether and how best to continue development of OMS527 in levodopa-induced dyskinesia (LID).

Cocaine use disorder (CUD);

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

Our pipeline of preclinical development programs includes the following:

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Lectin pathway disorders

Continue IND-enabling studies of current drug development candidate

Assess preclinical data on current drug development candidate

small-molecule inhibitors

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Identify drug development candidate for clinical trials

Adoptive T-Cell and Chimeric Antigen Receptor (CAR) T-Cell Therapies

Adoptive T-Cell and Immunostimulator Combination Therapies

Wide range of cancers

Complete preclinical proof of concept studies and evaluate data

Immunomodulators/Immunotoxins/Cancer Vaccines

Oncotoxins and Immunomodulators

Wide range of cancers

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classical, lectin, and alternative.

Omeros is focused on development of therapeutics to treat diseases associated with the lectin and/or alternative pathways of complement.

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.

MASP-2 Program - Lectin Pathway Disorders

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Importantly, inhibition of MASP-2 has been demonstrated not to interfere with the antibody-dependent classical complement activation pathway, a critical component of the acquired immune response to infection.

In addition to our clinical programs evaluating narsoplimab, we have generated positive preclinical data from MASP-2 inhibition in in vivo models of AMD, myocardial infarction, diabetic neuropathy, stroke, ischemia-reperfusion injury, and other diseases and disorders.

In addition to our clinical programs evaluating narsoplimab, we have generated positive preclinical data from MASP-2 inhibition in in vivo models of myocardial infarction, diabetic neuropathy, stroke, ischemia-reperfusion injury, and other diseases and disorders.

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 candidate in our MASP-2 inhibitor program is narsoplimab (OMS721), a proprietary, patented human monoclonal antibody targeting MASP-2.

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”):

We successfully completed a pivotal clinical trial for narsoplimab in TA-TMA and previously submitted to the FDA a biologics license application (“BLA”) seeking marketing approval for narsoplimab in this indication.

In late 2021, FDA issued a complete response letter (“CRL”) with respect to the BLA in which the agency indicated that additional information would be needed to support regulatory approval.

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 based on both response data and survival data from the completed pivotal trial versus a historical control group, with or without an independent literature analysis or based on survival data alone.

Consistent with subsequent interactions with FDA’s review division, we submitted to FDA in the fall of 2023 an analysis plan to assess already existing clinical trial data, existing data from a historical control population available from an external source, data from the narsoplimab expanded access program, and data directed to the mechanism of action of narsoplimab.

We are having ongoing discussions with the agency regarding the proposed analysis plan.

As a result, we are currently unable to estimate when we will submit the BLA or, subsequently, FDA’s timing for a decision regarding approval.

There can be no guarantee that FDA's specific recommendations for resubmission will be acceptable to Omeros in terms of the time and/or expenditure required or that any resubmission of the BLA will result in approval of narsoplimab for TA-TMA.

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.

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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 expect to complete our MAA submission following the resubmission of our BLA to FDA.

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 ARDS and we have developed both mechanistic and proof-of-concept clinical data indicating that narsoplimab may be an effective therapeutic for COVID-19, ARDS and/or related indications.

We also continue to explore the mounting evidence that MASP-2 and the lectin pathway are important drivers of post-acute sequelae SARS-CoV-2 (“PASC”), commonly known as long COVID, as well as potential approaches to identify acute COVID-19 patients at high-risk for hospitalization and mortality, to identify those PASC patients with hyperactive lectin pathway-driven disease, and to monitor response to treatment with MASP-2 inhibitors.

Narsoplimab has been administered under compassionate use to treat COVID-19 patients in Italy and in the U.S., achieving encouraging results.

Additionally, narsoplimab was the only complement inhibitor included in the I-SPY COVID-19 trial, a nationwide, late-stage adaptive platform trial sponsored by Quantum Leap Healthcare Collaborative (“Quantum Leap”), that evaluated multiple agents as potential treatments for severe COVID-19 requiring mechanical ventilation.

Results of the I-SPY COVID-19 trial were reported in September 2022.

The narsoplimab treatment arm was terminated prior to accrual of the maximum of 125 patients on the basis of analysis in a pre-consented patient population in which substantial bias was detected.

Although narsoplimab was not observed in this study to shorten the time to recovery in critically ill patients with COVID-19, analysis in the randomized patient population showed that the addition of narsoplimab to treatment of critically ill patients with COVID-19 reduces the mortality risk (hazard ratio [HR]=0.81, with probability [HR <1] equal to 0.77).

In approximately half of the patients who died in the narsoplimab group, narsoplimab was not given or was prematurely stopped, with those patients dying 9 to 35 days later.

Neither the trial’s futility nor graduation criteria had been met in the analysis of the randomized population at the time the narsoplimab arm was terminated.

Narsoplimab demonstrated the greatest reported survival benefit of all therapeutics evaluated in the I-SPY platform trial.

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.

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

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.

As such, the assay may be useful to identify patients 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.

We continue 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 or other infectious diseases.

IgA Nephropathy :

In October 2023, we announced the results of a pre-specified interim analysis in ARTEMIS-IGAN, our Phase 3 clinical trial evaluating narsoplimab for the treatment of immunoglobulin A (“IgA”) nephropathy.

Topline results of the interim analysis showed that narsoplimab did not achieve statistical significance on the primary endpoint of reduction in proteinuria from baseline compared to placebo.

Based on the absence of statistical significance and as previously agreed with FDA, we determined not to submit an application for approval of narsoplimab in this indication and the ARTEMIS-IGAN clinical trial has been discontinued.

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.

Dosing of all cohorts in a single-ascending dose Phase 1 clinical trial of OMS1029 was successfully completed in early 2023.

Pharmacokinetic (“PK”) and pharmacodynamic (“PD”) data show dose-proportional exposure and sustained lectin pathway inhibition, consistent with dosing of OMS1029 once quarterly, either intravenously or subcutaneously.

Dosing has also been completed in both of two planned cohorts of our ongoing Phase 1 multiple-ascending-dose study of OMS1029 in healthy volunteers and we expect the study to conclude in mid-2024.

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.

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

We continue to evaluate several potential indications for Phase 2 clinical development for OMS1029.

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

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

Available quantities are expected to be sufficient to support a Phase 2 clinical trial.

MASP-3 Program - Alternative Pathway Disorders

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

The lead candidate in our MASP-3 inhibitor program is OMS906, a proprietary, patented human monoclonal antibody targeting MASP-3.

Clinical development of OMS906 is currently focused on rapidly advancing to Phase 3 clinical trials in multiple APC-related disorders, including PNH and C3G.

OMS906 received designation from FDA as an orphan drug for the treatment of PNH in July 2022.

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 ” ):

We have three ongoing Phase 2 clinical trials evaluating OMS906 for PNH.

One in PNH patients who have not previously been treated with a complement inhibitor, and the second in PNH patients who have had an unsatisfactory response to ravulizumab, an inhibitor of complement component 5 (“C5”).

The third Phase 2 clinical trial is an open-label extension study to assess the long-term efficacy and safety of OMS906 in patients who have completed either of the other two PNH Phase 2 clinical trials.

In December 2023, updated results from a pre-specified interim analysis of our ongoing Phase 2 clinical trial of OMS906 in complement-inhibitor-naïve adults with PNH were featured in a podium presentation at the annual meeting of the American Society of Hematology.

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.

No patients were reported to have had a clinical breakthrough of PNH or a thrombotic event, and none were reported to require a transfusion while receiving OMS906 treatment.

Enrollment is complete and dosing is ongoing in our Phase 2 trial evaluating OMS906 in PNH patients who have had an unsatisfactory response to the C5 inhibitor ravulizumab.

Utilizing a “switch-over” design, this study enrolls PNH patients receiving ravulizumab, adds OMS906 to provide combination therapy with ravulizumab for 24 weeks, and then, in those patients who demonstrate a hemoglobin response with the combination therapy, switches to OMS906 monother apy.

Data from a pre-specified interim analysis showed that the addition of OMS906 therapy to ravulizumab treatment resulted in statistically significant and clinical meaningful improvements in both mean hemoglobin levels and absolute reticulocyte counts by week 4 of combination therapy, with a sustained response demonstrated through week 24 (the latest assessment prior to the interim analysis cutoff).

Full details from the interim analysis are expected to be presented at a major hematology conference in mid-2024.

Interim analysis data from the monotherapy portion of the trial is expected to be available in late 2024.

We have initiated an open-label extension study to assess the long-term efficacy and safety of OMS906 in patients with PNH.

In the extension study, PNH patients who have completed a previous study evaluating OMS906 roll directly into the extension study without a break in OMS906 treatment.

Data from this study will contribute to a planned BLA for O MS906 in the treatment of PNH.

Based on PK data from a successful Phase 1 single-ascending-dose study of OMS906 in healthy subjects and interim data from our ongoing clinical trials in PNH patients, we are exploring two different dosing frequencies - once every eight weeks and once every 12 weeks - for the Phase 3 studies and commercialization.

In February 2024 we met with FDA to discuss our development program for OMS906 in PNH.

We presented clinical and nonclinical data and requested input on expectations for Phase 3 studies and BLA submission.

FDA confirmed that the scope of our nonclinical program is sufficient to support Phase 3 clinical studies and provided input on dosing and design of the proposed Phase 3 program to support a BLA in PNH.

We expect to meet again with FDA later this year to discuss further details of the design of our Phase 3 studies.

Phase 3 clinical trials evaluating OMS906 in PNH are targeted to begin in late 2024.

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 OMS906 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 a Phase 3 trial with another inhibitor of the alternative pathway that reported positive results in the treatment of C3G.

Although a protocol amendment to modify the OMS906 dose based on information learned from our PNH program delayed initiation of the study, sites are now open in multiple countries and patients are being screened for enrollment.

We are targeting to initiate Phase 3 development for C3G in the first part of 2025, after Phase 2 results are available and discussions occur with regulators.

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.

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 advance testing to enable the filing of an investigational new drug application.

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

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

PDE7 Inhibitor Programs - OMS527

Our PDE7 inhibitor programs, which we refer to as OMS527, comprise multiple PDE7 inhibitor compounds and are based on our discoveries of previously unknown links between PDE7 and any addiction or compulsive disorder, and between PDE7 and any movement disorders.

Our PDE7 inhibitor program, which we refer to as OMS527, comprises multiple PDE7 inhibitor compounds and is based on our discoveries of previously unknown links between PDE7 and any addiction or compulsive disorder, and between PDE7 and any movement disorders.

PDE7 appears to modulate the dopaminergic system, which plays a significant role in regulating both addiction and movement.

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Cocaine Use Disorder ( “ CUD ” ):

In April 2023, we were awarded a grant from the National Institute on Drug Abuse, part of the National Institutes of Health, to develop our lead orally administered PDE7 inhibitor compound, for which we have successfully completed a Phase 1 study, for the treatment of CUD.

The grant amount, a total of $6.69 million over three years, 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 effectiveness of OMS527 in adults with CUD who receive concurrent intravenous cocaine.

The preclinical study is intended to provide the toxicology data necessary to support the human study of OMS527 in CUD.

That study is underway and is expected to be completed in late 2024.

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.

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.

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.

Levodopa-induced dyskinesia ( “ LID ” ):

With investigators at Emory University, we are also evaluating OMS527 as a potential treatment for LID, which are involuntary and often crippling movements in patients with Parkinson’s disease that are caused by prolonged treatment with levodopa, the most prescribed therapy for Parkinson’s disease.

With investigators at Emory University, we are also evaluating an OMS527 PDE7 inhibitor as a potential treatment for LID, which are involuntary and often crippling movements in patients with Parkinson’s disease that are caused by prolonged treatment with levodopa, the most prescribed therapy for Parkinson’s disease.

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

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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.

The National Institute on Drug Abuse (“NIDA”) provided substantially all of the funding for these clinical trials and solely oversaw the conduct of these trials.

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.

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Preclinical Programs and Platforms

Immuno-Oncology Platform

We have five immuno-oncology (I-O) platforms in preclinical development – adoptive T-cell therapy, CART-T, signaling-driven immunomodulators, antigen-driven immunomodulators that function both as therapeutics and vaccines, and oncotoxins.

To date, in vitro, ex vivo and animal studies using human cellular components have been positive with high response rates.

These data collectively reinforce the scientific basis for each platform, confirming our rationale for their design and development.

The data from our studies to date have demonstrated a number of potential advantages of our immuno-oncology franchise over other I-O approaches.

Our I-O franchise should be applicable to cancers broadly.

Rather than targeting only cell-surface antigens, our I-O franchise is designed to target both cell-surface and intracellular cancer targets, significantly broadening the range of indications.

Unlike other therapeutic approaches that affect either CD4 or CD8 levels, we have designed and demonstrated the ability of our technologies to increase levels of both CD4 and CD8 cells against a given cancer, both of which are necessary to kill tumor cells.

By increasing both the CD4 and CD8 cells, we should also be able to mitigate the “treatment exhaustion” – or the wearing-off of the treatment effect – seen with many currently available therapies.

This would allow repeated treatment, providing a sustained and better anti-tumor response.

Our cellular platforms do not require modification or engineering.

Instead, cells from the patient are simply treated outside the body and administered back to the patient.

We expect this simplicity in process, if achieved, to represent a major advance over currently available T-cell therapies, greatly decreasing both preparation time and cost.

When injected into the body, our novel biologic molecules should result not only in elimination of tumor cells but, importantly, in immune memory against future cancer relapse.

Our core technology is also amenable potentially to cancer prevention broadly.

We believe that all five platforms are entirely novel and proprietary.

We continue to confirm our results and to generate new data, all of which contribute to our intellectual property position.

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 drug candidates and our development programs.

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

We maintained internal marketing and sales capabilities with respect to OMIDRIA until the completion of the divestiture of that product on December 23, 2021.

As part of the divestiture, substantially all of our OMIDRIA sales and marketing team members accepted employment with Rayner and were separated from their employment at Omeros, effective as of December 31, 2021.

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.

Manufacturing, Supply and Commercial Operations

We currently do not own or operate manufacturing facilities.

We utilized contract manufacturers to produce, store and distribute OMIDRIA and currently rely on third parties to produce sufficient quantities of our drug candidates for use in pre-clinical and clinical studies and for the manufacture of narsoplimab for commercial use following potential regulatory approval.

We assigned or otherwise transitioned to Rayner our agreements with the third parties that produced, stored and distributed OMIDRIA.

We required manufacturers that produced active pharmaceutical ingredients (“APIs”) and finished drug products to operate in accordance with current Good Manufacturing Practices (“cGMPs”) and all other applicable laws and regulations.

In the U.S., we sold OMIDRIA through a limited number of wholesalers that distributed the product to ASCs and hospitals.

Title transferred upon delivery of OMIDRIA to the wholesaler.

For additional information, see Part II, Item 8, “ Note 7 – Discontinued Operations – Sale of OMIDRIA ” to our Consolidated Financial Statements in this Annual Report on Form 10-K.

Drug Candidates .

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

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

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

We anticipate that we will rely on contract manufacturers to develop and manufacture our drug 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 drug candidates.

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.

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

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

Other than our agreement for commercial supply of narsoplimab, we have not yet entered into a commercial supply agreement for any of our drug candidates.

If approved for commercial sale in the U.S., we expect to utilize one or more wholesalers for distribution of narsoplimab.

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.

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.

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.

The agreement is effective with respect to the commercial work contemplated thereunder for an initial term five years after which it automatically renews for two-year terms unless either party notifies the other party at least 12 months before the end of the then-current term that it does not intend to renew.

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.

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 OMS906 and options to access exclusive licenses to apply Xtend Fc technology to additional antibodies (the “Xencor Agreement”).

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 OMS906 program.

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.

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dosing of human subjects in Phase 1, 2 and 3 clinical trials;

receipt of marketing approval of a PDE7 inhibitor drug candidate;

receipt of marketing approval of a PDE7 inhibitor product candidate;

and reaching specified sales milestones.

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

Drug Candidates, Development Programs and Platforms.

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) and Fabhalta® (iptacopan).

Narsoplimab, OMS1029 and/or OMS906 will face competition from 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.

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.

Intellectual Property

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

Some of our drug 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 February 15, 2024, we owned or held worldwide exclusive licenses to a total of 78 issued patents and 60 pending patent applications in the U.S.

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

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.

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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 February 15, 2024, we exclusively controlled 38 issued patents and 32 pending patent applications in the U.S., and 793 issued patents and 435 pending patent applications in foreign markets, related to our MASP-2 program, including narsoplimab and our second-generation MASP-2 antibody OMS1029.

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 - OMS906 .

● 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 OMS906, as well as the option to obtain additional licenses to such technology for exclusive application to additional antibodies that we may select.

As of February 15, 2024, we exclusively controlled four issued patents and eight pending patent applications in the U.S.

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.

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● PPAR γ Program - OMS405 .

As of February 15, 2024, we owned three issued patents and one pending patent application in the U.S., and 37 issued patents and two pending patent applications in foreign markets, directed to our discoveries linking PPARγ and addictive disorders.

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.

● PDE7 Program - OMS527 .

As of February 15, 2024, we owned two issued patents and two pending patent application in the U.S., and 61 issued patents and two pending patent applications in foreign markets directed to our discoveries linking PDE7 to movement disorders, as well as three issued patent and two pending patent applications in the U.S., and 54 issued patents and three pending patent applications in foreign markets directed to the link between PDE7 and addiction and compulsive disorders.

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.

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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.

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

● Immuno-oncology Program.

O ur Immuno-oncology program includes five proprietary platforms relating to potential therapies for cancer.

As of February 15, 2024, we owned two pending patent applications in foreign markets directed to potential cancer therapies.

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.

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 drug 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 drug 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 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.

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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Accordingly, we cannot predict the breadth of claims that may be allowed or enforced in the patents that we own or have licensed or in third-party patents.

We have registered, and intend to maintain, the trademark “OMEROS” within the U.S.

Patent and Trademark Office in connection with the products and services we offer.

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

We have registered, and intend to maintain, the trademark “OMEROS”, as well as the associated “alpha/omega” logo within the U.S.

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

or any other jurisdiction.

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 drug 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.

In the U.S., our drug candidates are regulated by FDA as drugs or biologics under the Federal Food, Drug, and Cosmetic Act (“FDCA”) and implementing regulations and under the Public Health Service Act (“PHSA”).

In the EU, our drug 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.

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

In the U.S., our product candidates are regulated by FDA as drugs or biologics under the Federal Food, Drug, and Cosmetic Act (“FDCA”) and implementing regulations and under the Public Health Service Act (“PHSA”).

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.

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.

The steps required before a product may be approved for marketing by FDA, or the applicable regulatory authorities outside of the U.S., typically include the following:

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

and in countries outside the U.S., a Clinical Trial Application (“CTA”), is filed according to the country’s local regulations;

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

in other countries outside of the U.S.

and Europe, a CTA is filed according to the country’s local regulations;

● adequate and well-controlled human clinical trials to establish the efficacy and safety of the product for each indication for which approval is sought;

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● in the U.S., submission to FDA of a New Drug Application (“NDA”), in the case of a drug product, or a BLA in the case of a biologic product and, in Europe, submission to the EMA or a national regulatory authority of an MAA;

● satisfactory completion of inspections of one or more clinical sites at which clinical trials with the product were carried out and of the manufacturing facility or facilities at which the product is produced to assess compliance with Good Clinical Practices (“GCPs”), and cGMPs;

● FDA review and approval of an NDA or BLA, or review and approval of an MAA by the applicable regulatory authorities in the EU.

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Clinical Trials.

Clinical trials involve the administration of the investigational product to human subjects under the supervision of qualified personnel and must be conducted in accordance with local regulations and GCPs.

Clinical trials are conducted under protocols detailing, for example, the parameters to be used in monitoring patient safety and the efficacy criteria, or endpoints, to be evaluated.

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Disclosure of Clinical Trial Information .

Sponsors of clinical trials of certain FDA-regulated products, including prescription drugs, are required to register and disclose certain clinical trial information on a public website maintained by the U.S.

Sponsors of clinical trials of certain FDA-regulated products, including prescription drugs, are required to register and disclose certain clinical trial information on ClinicalTrials.gov , a public website maintained by the U.S.

National Institutes of Health.

Information related to the product, patient population, phase of investigation, study sites and investigator, and other aspects of the clinical trial is made public as part of the registration.

Sponsors are also obligated to disclose the results of these trials after completion.

Information related to the product, patient population, phase of investigation, study sites and investigator, and other aspects of an applicable clinical trial is made public as part of the registration.

Sponsors are also obligated to disclose the results of such trials after completion.

Disclosure of the results of these trials can be delayed for up to two years if the sponsor certifies that it is seeking approval of an unapproved product or that it will file an application for approval of a new indication for an approved product within one year.

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The type of submission in Europe depends on various factors and must be cleared by the appropriate authority prior to submission.

For most of our drug candidates, the centralized procedure will be either mandatory or available as an option.

For most of our product candidates, the centralized procedure will be either mandatory or available as an option.

If the regulatory authority determines that the application is not acceptable, it may refuse to accept the application for filing and review, outlining the deficiencies in the application and specifying additional information needed to file the application.

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A similar standard exists for BLAs.

Before approving an NDA or BLA, or an MAA, FDA or the EMA, respectively, may inspect one or more of the clinical sites at which the clinical studies were conducted to ensure that GCPs were followed and may inspect facilities at which the product is manufactured to ensure satisfactory compliance with cGMP.

Before approving an NDA or BLA, or an MAA, FDA or the EMA, respectively, may inspect one or more of the clinical sites at which the clinical studies were conducted to ensure that GCP were followed and may inspect facilities at which the product is manufactured to ensure satisfactory compliance with cGMP.

The FDA may refer the NDA or BLA to an advisory committee for review and recommendation as to whether the application should be approved and under what conditions.

The FDA is not bound by the recommendation of an advisory committee, but it generally follows such recommendation.

In addition, even if a drug candidate satisfied its endpoints with statistical significance during clinical trials, FDA could determine that the overall balance of risks and benefits for the drug candidate is not adequate to support approval, or only justifies approval for a narrow set of clinical uses and/or subject to restricted distribution or other burdensome post-approval requirements or limitations.

In addition, even if a product candidate satisfied its endpoints with statistical significance during clinical trials, FDA could determine that the overall balance of risks and benefits for the product candidate is not adequate to support approval, or only justifies approval for a narrow set of clinical uses and/or subject to restricted distribution or other burdensome post-approval requirements or limitations.

If approval is obtained changes to the approved product such as adding new indications, manufacturing changes, or additional labeling claims will require submission of a supplemental application, referred to as a variation in the EU, or, in some instances, a new application, for further review and approval.

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 drug candidates, such as those from our MASP-2 and MASP-3 programs, are considered biologics because they are derived from natural sources as opposed to being chemically synthesized.

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.

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

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.

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

Accordingly, manufacturers must continue to expend time, money, and effort in all areas of regulatory compliance, including production and quality control to comply with cGMPs.

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

Accordingly, manufacturers must continue to expend time, money, and effort in all areas of regulatory compliance, including production and quality control to comply with cGMP.

In addition, discovery of problems such as safety issues may result in changes in labeling or restrictions on a product manufacturer or marketing authorization holder, including removal of the product from the market.

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Studies that are conducted to demonstrate a drug’s effect on a surrogate or intermediate clinical endpoint for accelerated approval must be adequate and well-controlled as required by the FDCA.

Following accelerated approval, FDA requires that the company provide confirmatory evidence, which may include certain adequate and well-controlled post-marketing clinical studies to verify the clinical benefit of the product, and FDA may impose restrictions on distribution to assure safe use.

Pursuant to new statutory authority under the Food and Drug Omnibus Reform Act of 2022, FDA can require confirmatory studies to be underway at the time of the accelerated approval.

If the required confirmatory studies fail to verify the clinical benefit of the drug, or if the applicant fails to perform the required confirmatory studies with due diligence, FDA may withdraw approval of the drug under streamlined procedures in accordance with FDA’s regulations.

Following accelerated approval, FDA requires that companies conduct confirmatory studies post-approval to verify and describe the anticipated effect on irreversible morbidity or mortality or other clinical benefit.

FDA may also impose restrictions on distribution to assure safe use.

Pursuant to statutory authority under the Food and Drug Omnibus Reform Act of 2022, FDA can require confirmatory studies to be underway at the time of the accelerated approval.

If the required confirmatory studies fail to verify and describe the clinical benefit of the drug, or if the applicant fails to perform the required confirmatory studies with due diligence, FDA may withdraw approval of the drug under expedited procedures.

FDA may also withdraw approval of a drug if, among other things, other evidence demonstrates that the drug product is not shown to be safe or effective under its conditions of use.

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for which the cost of developing and making the product available in the U.S.

for this type of disease or condition is not likely to be recovered from U.S.

for the applicable disease or condition is not likely to be recovered from U.S.

sales for that product.

The granting of orphan designation does not alter the standard regulatory requirements (other than payment of certain fees and the applicability of certain pediatric assessment requirements), nor does it alter the standards or process for obtaining marketing approval.

The grant of orphan designation does not alter the standard regulatory requirements (other than payment of certain fees and the applicability of certain pediatric assessment requirements), nor does it alter the standards or process for obtaining marketing approval.

The sponsor of a product that has an orphan drug designation qualifies for various development incentives specified in the ODA, including a tax credit of up to 25% of expenditures on qualified clinical testing for the orphan drug.

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Healthcare compliance laws .

In the U.S., commercialization of our drug 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 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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states have enacted similar laws requiring periodic reporting and/or disclosure related to our marketing, sales and other activities, or regulating certain sales and marketing activities, such as provision of meals to certain health care providers.

We may also be subject to federal or state privacy laws if we receive protected patient health information.

We may also be subject to federal or state privacy laws if we receive protected patient health information or consumer health information.

Similar requirements apply to our operations outside of the U.S.

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Pharmaceutical Pricing and Reimbursement

and foreign markets, our ability to commercialize our drug candidates successfully, and to attract commercialization partners for our drug 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 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.

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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Third-party private and governmental payers are increasingly challenging the prices charged for medicines and examining their cost-effectiveness in addition to their safety and efficacy.

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

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

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.

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, the 2010 Affordable Care Act (the “ACA”), is intended to broaden access to health insurance, reduce or constrain the growth of healthcare spending, enhance remedies against fraud and abuse, add transparency requirements for the healthcare and health insurance industries, impose new taxes and fees on the health industry and impose additional health policy reforms.

Other legislative changes included 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 4 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.

In December 2017, portions of the ACA dealing with the individual mandate insurance requirement were effectively repealed by the Tax Cuts and Jobs Act of 2017.

Containment of healthcare costs has been a priority of federal, state, and foreign governments, and the prices of drug products have been a focus of this effort.

Governments have shown significant interest in implementing cost-containment programs.

This interest has resulted in significant proposed and enacted reform measures affecting healthcare reimbursement and drug pricing, including the enactment in August 2022 of significant changes to potential Medicare drug product reimbursement through government negotiation of certain drug prices, as well as manufacturer discount and inflation rebate obligations under the Inflation Reduction Act (the “IRA”).

We are unable to predict what additional legislation, regulations, policies or court orders, if any, relating to the healthcare industry or coverage and reimbursement may be enacted or imposed in the future or what effect such legislation, regulations, policies or court orders would have on our business.

This interest has resulted in significant proposed and enacted reform measures affecting healthcare reimbursement and drug pricing, including the enactment in August 2022 of significant changes to potential Medicare drug product reimbursement through government negotiation of certain drug prices, as well as Medicare manufacturer discount and inflation rebate obligations under the Inflation Reduction Act (the “IRA”).

We are unable to predict what additionallegislation, regulations, policies, executive orders or court orders, if any, relating to the healthcare industry or coverage and reimbursement may be enacted or imposed in the future or what effect such legislation, regulations, policies or court orders would have on our business.

Any cost-containment measures, including those listed above, or other healthcare system reforms that are adopted could have a material adverse effect on our business prospects and financial operations.

Governments in the various member states of the EU influence or control the price of medicinal products in their countries through their pricing and reimbursement rules and control of national healthcare systems that fund a large part of the cost of those products to consumers.

To obtain reimbursement or pricing approval, some of these countries may require the completion of clinical trials or pharmacoeconomic studies that assess the cost-effectiveness of a product or drug candidate relative to currently available therapies or relative to a specified standard.

To obtain reimbursement or pricing approval, some of these countries may require the completion of clinical trials or pharmacoeconomic studies that assess the cost-effectiveness of a product or product candidate relative to currently available therapies or relative to a specified standard.

The downward pressure on healthcare costs in general, and prescription medicines in particular, has become very intense and is creating increasingly high barriers to the entry of new products in these markets.

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As of December 31, 2024, we had 202 full-time employees, 136 of whom are in research and development, 19 of whom are in sales and marketing and 47 of whom are in finance, legal, business development and administration.

Our full-time employees include six with M.Ds and 40 with Ph.Ds., of whom five and 39, respectively, are in research and development.

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.

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

Information about Our Executive Officers and Significant Employees

The following table provides information regarding our executive officers and significant employees as of April 1, 2024:

The following table provides information regarding our executive officers and significant employees as of March 13, 2025:

Executive Officers:

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Vice President, Science and Chief Scientific Officer

Vice President, Chief Business Development Officer

Andreas Grauer, M.D.

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Demopulos, M.D., a member of our board of directors.

Jacobsen has served as our vice president, finance, chief accounting officer and treasurer since October 2013.

Borges has served as our vice president, finance, chief accounting officer and treasurer since June 2024.

He joined Omeros in June 2020 as senior director, financial planning & analysis and served as associate vice president, financial planning & analysis from April 2022 to June 2024.

Prior to joining Omeros, Mr.

Jacobsen served as vice president of finance of Sarepta Therapeutics, Inc.

from September 2011 to May 2013 and as its chief accounting officer from September 2011 to December 2012.

From April 2007 to August 2011, Mr.

Jacobsen was vice president and chief accounting officer at ZymoGenetics, Inc.

Prior to his service with ZymoGenetics, Mr.

Jacobsen held various roles at ICOS Corporation, including senior director of finance and corporate controller.

From April 1995 to October 2001, Mr.

Jacobsen held vice president of finance or chief financial officer roles at three companies in the software, computer hardware and internet retailing industries, two of which were publicly traded.

Jacobsen is a certified public accountant and received his bachelor’s degree in accounting from Idaho State University.

Borges served as vice president, finance and administration, at Bulletproof 360, Inc., a health and wellness company, where he directed and managed all aspects of corporate finance, accounting, information technology, human resources, facilities, and legal from October 2014 until October 2019.

From May 2009 to June 2014, Mr.

Borges served as chief financial officer and vice president of Advanced Refreshment LLC, a producer of private label bottled water and water-based beverages.

From July 2001 to May 2009, Mr.

Borges served as finance and business integration director at Merck & Co., Inc.

(“Merck”), a biopharmaceutical company, after Merck acquired Rosetta Inpharmatics, where Mr.

Borges had been serving as director of finance & administration/controller since 1998.

Borges is a certified public accountant and received his B.S.

in Commerce in Accounting from Santa Clara University.

Cancelmo, J.D.

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from the Aristotelian University of Greece.

Ghesquiere has served as our chief business development officer since August 2024.

Prior to joining Omeros, Mr.

Ghesquiere served as managing director of Adrenaline Venture & Advisory LLC, an international advisory firm, advising biotech and technology companies, which he founded in 2012.

Ghesquiere served, from November 2013 to December 2023, as senior vice president, corporate & business development of NanoString Technologies, focusing on life science tools, informatics, and molecular diagnostics (acquired by Bruker Corporation).

Ghesquiere served as senior vice president, corporate & business development at Dendreon Corporation, a biotechnology company, from 2011 to 2012.

From 2005 until its acquisition by Astellas in 2010, Mr.

Ghesquiere also held a variety of executive positions at OSI Pharmaceuticals, including senior vice-president of corporate & business development and managing director of OSI’s corporate venture capital arm.

Earlier in his career, Mr.

Ghesquiere served in business development and alliance management roles at Aventis Pharmaceuticals (acquired by Sanofi) and worked in product marketing/new product planning at Johnson & Johnson.

Ghesquiere received his M.B.A.

from the University of Western Ontario’s Ivey Business School and his B.A.

in economics from the University of Western Ontario.

Andreas Grauer, M.D.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business