Omeros Stock Price, News & Analysis

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.

Omeros (NASDAQ: OMER) announced robust statistical analysis results for narsoplimab's Expanded Access Program (EAP) in treating transplant-associated thrombotic microangiopathy (TA-TMA). The analysis showed that narsoplimab significantly reduced mortality risk in high-risk TA-TMA patients by 2-3 fold (hazard ratio = 0.34-0.46) with highly significant p-values (<0.00001).

The EAP included 136 TA-TMA patients, with impressive survival rates: 62% one-year survival for previously untreated patients (58% adults, 79% children) and 44% for treatment-refractory patients - more than double the historical survival rate of <20%. The results will be included in narsoplimab's BLA resubmission to FDA this quarter and MAA submission to European regulators by mid-year.

No safety concerns were identified, and the data consistently demonstrated narsoplimab's effectiveness in treating TA-TMA, a life-threatening complication with no currently approved treatment.

Omeros (OMER) has made available on its website materials from two presentations delivered at the 2025 Tandem Meetings, focusing on narsoplimab treatment outcomes. The presentations include survival data from Dr. Michelle Schoettler's study of 128 allogeneic transplant patients with TA-TMA treated under the expanded access program, and Dr. Piyatida Chumnumsiriwath's poster on outcomes from adult TA-TMA patients who received narsoplimab after unsuccessful eculizumab treatment.

Omeros (NASDAQ: OMER) has announced two upcoming presentations at the 2025 Tandem Meetings in Honolulu, Hawaii, focusing on narsoplimab treatment outcomes for TA-TMA patients under an expanded access program. The first presentation, by Dr. Michelle Schoettler from Emory University School of Medicine, will discuss overall survival rates among 128 allogeneic transplant patients treated with narsoplimab.

The second presentation, by Dr. Piyatida Chumnumsiriwath from UC Irvine, will showcase findings from a single-center study of adult TA-TMA patients who received narsoplimab after unsuccessful eculizumab treatment. Both presentations are scheduled for February 13, 2025, with Dr. Schoettler's podium presentation at 3:15 PM HST and Dr. Chumnumsiriwath's poster session at 6:45 PM HST.

Omeros (NASDAQ: OMER) announced positive statistical sensitivity analysis results for narsoplimab in treating transplant-associated thrombotic microangiopathy (TA-TMA). The analyses validate previously reported primary endpoint results showing 2-fold to 4-fold reduction in mortality risk (hazard ratios 0.24-0.42) with p-values ranging from 0.0124 to <0.00001.

The primary endpoint analysis demonstrated an over 3-fold reduction in mortality risk (hazard ratio = 0.32) in narsoplimab-treated patients compared to external control. The company plans to resubmit its Biologics License Application (BLA) to FDA this quarter and targets Marketing Authorization Application (MAA) submission to European regulators by mid-year. Narsoplimab aims to become the first approved treatment for TA-TMA, a life-threatening complication in stem cell transplantation.