Omeros Stock Price, News & Analysis

Omeros Corporation (NASDAQ: OMER) has scheduled the release of its Q1 2025 financial results for Thursday, May 15, 2025, after market close. The company will host a conference call and webcast at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) on the same day. Management will discuss financial results, recent developments, and highlights. Investors can access the live webcast through Omeros' website at investor.omeros.com/upcoming-events. For phone access, participants must pre-register to receive a PIN. A replay will be available at investor.omeros.com/archived-events.

Omeros Corporation (OMER) has announced significant debt restructuring agreements to manage its $80.5 million of Convertible Senior Notes due 2026. The company will exchange $70.5 million of its 5.25% notes for new 9.50% Convertible Senior Notes due 2029, and convert $10 million into common stock. The new notes feature a 35% premium conversion rate and will mature on June 15, 2029. Following these transactions, only $17.4 million of the 2026 notes will remain outstanding. This restructuring eliminates the need for a $20 million term loan prepayment due in November 2025 and reduces potential debt repayment obligations over the next 12 months from $117.9 million to $17.4 million. The Equitization Transaction is expected to complete by September 15, 2025.

Omeros Corporation (OMER) announced that the FDA has accepted the resubmission of its Biologics License Application (BLA) for narsoplimab, targeting the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA). The FDA has assigned a PDUFA date in late September 2025.

The Class 2 resubmission includes crucial data showing statistically significant and clinically meaningful improvements in survival for narsoplimab-treated patients compared to an external control group. Additional data from the company's expanded access program, treating both adult and pediatric TA-TMA patients, was also included. Omeros is currently responding to FDA information requests and plans to submit a marketing authorization application to the European Medicines Agency later this quarter.

Omeros (OMER) has established an Oncology Clinical Steering Committee to advance its OncotoX biologics program targeting acute myeloid leukemia (AML). The committee comprises distinguished clinical experts from leading National Comprehensive Cancer Network Centers, chaired by Dr. Naval Daver from MD Anderson Cancer Center.

The OncotoX-AML program features engineered molecules that deliver toxic payloads to cancer cells. In animal studies, the therapeutic has demonstrated superior efficacy to current standard treatments, showing effectiveness against tumors with mutations found in nearly 90% of AML patients. The treatment targets both AML blasts and leukemia stem cells, while preliminary studies indicate good tolerability at doses well above efficacious levels.

AML, affecting over 20,000 U.S. patients annually with 11,000+ deaths, represents a significant market opportunity. The global AML therapeutic market is projected to reach over $6 billion by 2030, within a broader leukemia therapeutic market forecast of $29 billion.

Omeros (OMER) announced the upcoming first public presentation of its proprietary Targeted Complement Activating Therapy™ (T-CAT™) platform at the European Congress on Infectious Diseases 2025. The technology represents a novel class of pathogen-targeting recombinant antibodies designed to combat multidrug-resistant organisms (MDROs).

T-CAT's unique mechanism involves engineered antibodies containing complement-cleaving enzymes that directly activate complement on microbial cell surfaces, leading to their destruction. In animal studies, T-CAT antibodies demonstrated effectiveness against life-threatening infections caused by several WHO-designated priority bacterial pathogens, showing >99% reduction in organisms and increased survival rates.

The platform aims to address the global MDRO crisis, which causes over 2.8 million resistant infections and 35,000 deaths annually in the U.S. alone. Unlike current antimicrobials, T-CAT antibodies are designed to be effective against various pathogens without promoting drug resistance. The anti-infectives market reached $46 billion in U.S. sales and $135 billion globally in 2024.

Omeros (OMER) reported Q4 2024 financial results with a net loss of $31.4 million ($0.54 per share), compared to Q3 2024's loss of $32.2 million. The full-year 2024 net loss was $156.8 million ($2.70 per share), up from $117.8 million in 2023.

Cash position stood at $90.1 million as of December 31, 2024, marking an $81.7 million decrease from 2023. Significant outlays included $21.7 million for convertible notes repurchase, $19.1 million for narsoplimab drug substance, and $1.9 million for senior debt transactions.

Key developments include the resubmission of narsoplimab BLA for TA-TMA treatment, with FDA action expected in September 2025. The company plans to submit European MAA in H1 2025. Phase 3 trials for zaltenibart in PNH treatment have begun, with data expected late next year.

Omeros (NASDAQ: OMER) has scheduled the release of its fourth quarter and year-end financial results for Monday, March 31, 2025, after market close. The company will host a conference call and webcast at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss financial results and recent developments.

Investors can access the live webcast through Omeros' website at investor.omeros.com/upcoming-events. For phone participation, registration is required to receive a PIN. Participants can either dial in using the provided conference line and PIN or use the 'Call Me' option. A replay will be available at investor.omeros.com/archived-events.

Omeros (OMER) has initiated site activation for its Phase 3 program evaluating zaltenibart in paroxysmal nocturnal hemoglobinuria (PNH). The program spans 120 clinical sites across 30 countries, with data for BLA submission expected in Q4 2026.

Zaltenibart, administered intravenously once every eight weeks, demonstrates advantages over current treatments that require more frequent dosing. The Phase 3 program includes two trials comparing zaltenibart to C5 inhibitors eculizumab and ravulizumab, targeting both treatment-naive patients and those with inadequate response to existing therapies.

Phase 2 data showed zaltenibart effectively inhibits both intravascular and extravascular hemolysis, achieving normal hemoglobin levels with no significant safety concerns. The global PNH market is valued at $3.8 billion in 2023, with projections reaching $11.7 billion by 2034.

Omeros (OMER) has secured a $4.02 million funding commitment from the National Institute on Drug Abuse (NIDA) for the clinical development of OMS527, their oral phosphodiesterase 7 inhibitor targeting cocaine use disorder (CUD).

The funding was triggered by successful drug-drug-interaction safety studies where OMS527 showed no enhancement of cocaine's detrimental effects and demonstrated beneficial outcomes in cocaine-administered animals. The grant will support a Phase 1b clinical trial to assess OMS527's safety and efficacy, with initial data expected in Q4 2025.

OMS527 has shown promising results in animal models across various addictions including cocaine, opioids, nicotine, and alcohol, reducing both craving and relapse. A previous Phase 1 trial demonstrated favorable safety and pharmacokinetics supporting once-daily dosing. With approximately 1.3 million Americans affected by CUD and over 27,000 cocaine-related deaths in 2022, OMS527 aims to address a significant unmet medical need as there are currently no approved treatments for CUD.