Omeros Corporation Reports Second Quarter 2025 Financial Results, Advances Narsoplimab Regulatory Reviews, and Strengthens Balance Sheet
Omeros Corporation (Nasdaq: OMER), a biopharmaceutical company dedicated to developing novel therapeutics for serious diseases, today announced its financial results for the second quarter ended June 30, 2025, alongside important business highlights that underscore the company’s progress on regulatory filings, clinical programs, and financial restructuring.
The quarter was marked by substantial operational advancements, particularly related to the company’s lead asset, narsoplimab, which is under regulatory review in both the United States and Europe for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA). Additionally, Omeros strengthened its balance sheet through financing and debt restructuring transactions, reduced its net loss significantly year-over-year, and advanced its pipeline of therapies targeting addiction, oncology, and immune-mediated diseases.
Financial Performance Overview
For the second quarter of 2025, Omeros reported a net loss of $25.4 million, or $0.43 per share, representing a significant improvement compared to a net loss of $56.0 million, or $0.97 per share, in the second quarter of 2024.
For the first six months of 2025, the company’s net loss totaled $58.9 million, or $1.01 per share, compared to $93.2 million, or $1.60 per share, in the same period of 2024.
The reduction in net loss was largely attributed to lower manufacturing expenses, particularly those related to narsoplimab drug substance production, which weighed heavily on financial results in the prior-year quarter.
As of June 30, 2025, Omeros held $28.7 million in cash and short-term investments. Shortly after quarter-end, on July 28, 2025, the company bolstered its liquidity position with $20.6 million in net proceeds from a registered direct equity offering with Polar Asset Management Partners. The transaction involved the sale of 5,365,853 shares of common stock at a price of $4.10 per share, representing a 14% premium to the market closing price at the time of pricing—demonstrating investor confidence in the company’s near-term prospects.
Key Regulatory and Clinical Developments
Progress with Narsoplimab in TA-TMA
The centerpiece of Omeros’ pipeline is narsoplimab, a monoclonal antibody that inhibits mannan-binding lectin-associated serine protease-2 (MASP-2), a key driver in the lectin pathway of the complement system.
In March 2025, Omeros resubmitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval for narsoplimab in TA-TMA, a rare but often fatal complication of stem cell transplantation for which no approved therapy currently exists.
The FDA accepted the filing as a class 2 resubmission, assigning an initial Prescription Drug User Fee Act (PDUFA) action date of September 25, 2025. Following Omeros’ submission of additional information requested by the FDA, the agency extended the PDUFA date to December 26, 2025. Importantly, the FDA indicated that, provided no major deficiencies arise, labeling discussions could begin as early as October 2025.
According to Omeros, all analyses conducted to date in collaboration with the FDA have been consistent with previously submitted data and continue to demonstrate statistically significant survival and clinical benefits for narsoplimab in TA-TMA patients.
In parallel, Omeros submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in June 2025. The EMA has validated the filing, officially commencing review by the Committee for Medicinal Products for Human Use (CHMP). A decision is expected in mid-2026.
The company has already initiated commercial readiness activities, including phased onboarding of experienced hematology-focused sales professionals, engagement with transplant centers, payer discussions, and hospital formulary exchanges. Feedback from stakeholders has been encouraging, with recognition of narsoplimab’s differentiated clinical profile compared to off-label use of C5 inhibitors such as eculizumab, which have been associated with elevated infection risks and mortality in pediatric TA-TMA patients.
Notably, two manuscripts describing narsoplimab’s survival benefits have been submitted to high-impact medical journals. One has already been accepted for publication, while the other remains under review. Together, these data reinforce the growing consensus around narsoplimab’s potential as a first-in-class treatment option for this life-threatening condition.
Pipeline and Research Highlights
Beyond narsoplimab, Omeros continues to invest strategically in its pipeline, with several programs advancing through preclinical and early clinical stages.
OMS527: Addressing Addiction and Compulsive Disorders
Omeros’ OMS527, a phosphodiesterase 7 (PDE7) inhibitor, is being developed as a potential first-in-class therapy for cocaine use disorder and broader addictive and compulsive disorders.
The program is being supported by a $6.24 million grant from the National Institute on Drug Abuse (NIDA), part of the NIH. To date, Omeros has received $1.5 million of this funding. The grant covers critical preclinical toxicology studies and supports a planned in-patient, placebo-controlled clinical trial in adults with cocaine use disorder.
Preclinical studies designed by NIDA toxicologists have now been successfully completed, demonstrating no adverse safety signals when OMS527 was administered concurrently with cocaine. These results support progression to clinical testing.
The FDA has requested additional preclinical information before allowing Omeros to initiate the in-patient study, which the company now targets for early 2026. If successful, OMS527 could become the first approved pharmacologic therapy for cocaine addiction, a condition with enormous public health implications and no currently approved treatments.
Oncology: OncotoX-AML Program
In oncology, Omeros is advancing its OncotoX biologics platform, with a lead therapeutic candidate targeting acute myeloid leukemia (AML).
Despite limiting the scope of recent expenditures to conserve cash, Omeros estimates that its OncotoX-AML candidate could enter clinical testing within 18 to 24 months. Preclinical results have been highly promising, showing superior efficacy compared to current AML standards of care across a wide range of genetic mutations, including TP53, NPM1, KMT2A, and FLT3.
To help guide development, the company has convened an Oncology Clinical Steering Committee composed of leading AML experts from top U.S. cancer centers. This group is expected to provide strategic and clinical insights as Omeros prepares for eventual IND submission and trial design.
Other Pipeline Assets
Other clinical programs remain in the company’s portfolio but are currently deprioritized while resources are focused on narsoplimab. These include:
- Zaltenibart (MASP-3 inhibitor), poised for a Phase 3 trial.
- OMS1029 (long-acting MASP-2 inhibitor), ready for Phase 2 initiation.
Both programs remain on hold but are expected to resume when resources permit or through potential partnerships.
Corporate and Financing Developments
Omeros executed significant financial restructuring in the quarter, aimed at reducing near-term debt obligations and extending maturities.
On May 14, 2025, the company exchanged $70.8 million of its convertible senior notes due 2026 for newly issued notes due 2029, thereby extending repayment obligations.
Separately, on May 12, 2025, Omeros entered an equitization agreement, whereby affiliated holders converted $10.0 million of 2026 notes into common stock.
As a result, the outstanding balance of 2026 notes was reduced from $97.9 million to $17.1 million. These transactions also eliminated the need for a $20 million prepayment (plus $1 million premium) on secured term debt that otherwise would have accelerated maturity in late 2025.
Looking forward, Omeros disclosed that it is actively engaged in partnership and licensing discussions around certain clinical assets. One such transaction, currently under advanced negotiation, carries a potential multi-billion-dollar value (excluding royalties). If consummated, the deal is expected to provide upfront cash sufficient to:
- Fully repay the $67.1 million term loan outstanding, including prepayment premiums.
- Retire the $17.1 million remaining principal on 2026 notes.
- Fund more than 12 months of operations beyond closing.
The deal would also include milestone payments and royalties tied to regulatory approvals and commercial sales. However, the company cautioned that there can be no assurance the transaction will close.
Additional Financial Details
- OMIDRIA royalties: Omeros earned $8.6 million in Q2 royalties from Rayner Surgical’s U.S. net sales of $28.6 million, down from $10.9 million in the same quarter of 2024. Under its agreement with DRI Health Acquisition, all royalties are directed to DRI through 2031.
- Operating expenses: Total operating expenses were $32.4 million, compared to $59.2 million in Q2 2024, reflecting reduced narsoplimab manufacturing and reprioritization of programs.
- Interest expense: Declined sharply to $15,000 from $9.2 million in the prior year, largely due to changes in OMIDRIA royalty obligation accounting.
- Other income: Interest and other income was $1.2 million, compared to $3.2 million in Q2 2024, reflecting lower cash balances.
- Loss on extinguishment of debt: The exchange of 2026 notes for 2029 notes resulted in a $3.0 million non-cash loss.
- Net income from discontinued operations: $0.5 million in Q2 2025, down from $9.1 million in the prior year, due to lower OMIDRIA royalty asset remeasurement gains.
CEO Commentary
Dr. Gregory A. Demopulos, Chairman and CEO of Omeros, emphasized the company’s progress:
“During the second quarter, we significantly improved our balance sheet, reducing near-term debt by more than $100 million and adding new capital from a long-horizon investor through our equity financing with Polar Asset Management. Working closely with the FDA, we are preparing for the anticipated approval and launch of narsoplimab in TA-TMA, where the unmet need is significant. We are also advancing OMS527 for cocaine use disorder, progressing our OncotoX-AML program, and maintaining readiness to restart development of other complement inhibitors when appropriate. With strong industry interest in our portfolio, we believe several value-driving milestones are ahead in 2025 and 2026.”
The second quarter of 2025 marked a turning point for Omeros, with regulatory progress for narsoplimab, improved financial performance, reduced debt obligations, and clear visibility on near-term catalysts. With FDA and EMA reviews underway, OMS527 preparing for first-in-human cocaine use disorder studies, and OncotoX-AML advancing toward the clinic, the company is positioning itself for a transformative period over the next 12–18 months.
