Omeros(OMER) - 2025 Q2 - Quarterly Results

Key Highlights and Financial Summary Omeros significantly reduced its net loss in Q2 2025, primarily due to lower manufacturing expenses, while strengthening its balance sheet through a registered direct offering and debt restructuring. Financial Summary | Metric | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--- | :--- | :--- | :--- | :--- | | Net Loss | $25.4M | $56.0M | $58.9M | $93.2M | | Net Loss Per Share | $0.43 | $0.97 | $1.01 | $1.60 | - The FDA accepted the resubmitted Biologics License Application (BLA) for narsoplimab in TA-TMA, extending the PDUFA target action date to December 26, 2025, following an information request[2] - The company improved its balance sheet by exchanging $70.8 million of 2026 convertible notes for new 2029 notes and converting an additional $10.0 million into common stock, reducing the 2026 notes principal from $97.9 million to $17.1 million[2] - Omeros is in advanced discussions for a potential asset acquisition or licensing agreement with a total transaction value potentially in the multi-billions, exclusive of royalties, with an expected upfront payment to repay all term debt and fund over 12 months of operations[2][3] CEO Statement CEO Gregory A. Demopulos highlighted significant balance sheet improvements, including over $100 million in debt reduction and new capital, alongside pipeline advancements for narsoplimab, OMS527, and OncotoX-AML. - The company significantly improved its balance sheet, reducing near-term debt by over $100 million and adding new capital through an equity financing with Polar Asset Management[4] - Key pipeline programs are advancing: NIDA continues to fund the PDE7 inhibitor program (OMS527) for cocaine use disorder, and the OncotoX-AML program is on track to enter the clinic in 18-24 months with promising data[4] - Other pipeline assets, including the MASP-3 inhibitor zaltenibart and the long-acting MASP-2 inhibitor OMS1029, are paused but ready to initiate Phase 3 and Phase 2 trials, respectively, as the company prioritizes narsoplimab[4] Pipeline and Recent Developments Omeros is actively preparing for the commercial launch of narsoplimab, advancing the OMS527 program for cocaine addiction towards a clinical study in H1 2026, and progressing the OncotoX-AML oncology program towards clinical trials within 18-24 months. Narsoplimab (MASP-2 Inhibitor) The company is preparing for the commercial launch of narsoplimab for TA-TMA, focusing on high-priority transplant centers and engaging with payers, supported by recent publications on its safety and survival benefits. - Commercial launch preparations are underway, including a phased onboarding of experienced sales professionals to target the highest-volume transplant centers first[5] - Pre-approval discussions with hospital formulary decision-makers and payers have yielded encouraging feedback, with stakeholders recognizing narsoplimab's strong clinical profile[5] - A recent study highlighted that the off-label C5 inhibitor eculizumab was associated with an 8.5-fold higher rate of bacteremia infections and a sixfold higher one-year infection-related mortality in pediatric TA-TMA patients[5] OMS527 (PDE7 Inhibitor Program) The OMS527 program, targeting cocaine use disorder, is supported by a NIDA grant, has completed preclinical interaction studies without safety issues, and is preparing for a clinical in-patient study targeted for the first half of 2026. - The program is supported by a $6.24 million grant from the National Institute on Drug Abuse (NIDA) to develop OMS527 for cocaine use disorder[5] - Preclinical cocaine interaction and toxicology studies, designed by NIDA, were successfully completed with no safety findings, supporting the planned human study[5] - An in-patient clinical study in cocaine users is targeted for the first part of 2026, pending submission of additional preclinical information requested by the FDA[5] Oncology Platform (OncotoX-AML) The OncotoX-AML program is advancing through IND-enabling work, with a projected timeline to enter clinical trials in 18-24 months, supported by strong preclinical data and a new clinical steering committee. - The OncotoX-AML therapeutic is estimated to enter the clinic in 18-24 months, with IND-enabling work advancing, albeit at a limited scope to preserve capital[5] - In preclinical models, the OncotoX-AML therapeutic has consistently demonstrated superior efficacy to current AML standard of care treatments and shows broad application across various genetic mutations[5] - A newly established Oncology Clinical Steering Committee, composed of leaders from premier U.S. cancer centers, will help guide the program's development[5] Q2 2025 Financial Results Omeros reported a Q2 2025 net loss of $25.4 million, a significant improvement from Q2 2024, driven by a $26.8 million decrease in operating expenses, ending the quarter with $28.7 million in cash, subsequently bolstered by over $22 million in financing. Consolidated Statements of Operations Omeros reported a Q2 2025 net loss of $25.4 million, a significant improvement from the $56.0 million loss in Q2 2024, driven by a $26.8 million decrease in total operating expenses, mainly due to lower narsoplimab manufacturing costs. Income Statement (in thousands) | Income Statement (in thousands) | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Total costs and expenses | $32,354 | $59,157 | | Loss from operations | ($32,354) | ($59,157) | | Net loss | ($25,424) | ($56,041) | | Net loss per share | ($0.43) | ($0.97) | - The $26.8 million decrease in quarterly operating expenses was primarily due to $17.6 million in narsoplimab manufacturing costs incurred in Q2 2024 and a temporary pause of certain programs to preserve capital[10] - OMIDRIA royalties earned in Q2 2025 were $8.6 million, down from $10.9 million in Q2 2024[9] Consolidated Balance Sheet As of June 30, 2025, Omeros had total assets of $200.6 million and a total shareholders' deficit of $228.7 million, with current assets decreasing due to reduced cash and short-term investments, and a restructured debt profile. Balance Sheet (in thousands) | Balance Sheet (in thousands) | June 30, 2025 | Dec 31, 2024 | | :--- | :--- | :--- | | Cash and short-term investments | $28,744 | $90,132 | | Total current assets | $69,647 | $134,120 | | Total assets | $200,569 | $277,079 | | Total liabilities | $429,254 | $459,688 | | Total shareholders' deficit | ($228,685) | ($182,609) | Liquidity and Capital Resources The company held $28.7 million in cash and short-term investments at the end of Q2 2025, subsequently raising an additional $20.6 million net through a registered direct offering and $2.1 million gross via its ATM facility, while maintaining a minimum cash balance of $25.0 million. - As of June 30, 2025, the company had $28.7 million in cash and short-term investments[7] - Subsequent to quarter-end, the company raised $20.6 million in net cash proceeds from a registered direct offering and $2.1 million in gross proceeds from its ATM facility[8] - A covenant in the company's credit agreement requires maintaining a minimum of $25.0 million in unrestricted cash, cash equivalents, and short-term investments[7] Corporate Information This section provides details about the company's conference call, a corporate overview of its focus on immunologic disorders and its drug pipeline, and the standard forward-looking statements disclaimer. - Omeros is a biopharmaceutical company focused on discovering and developing therapeutics for immunologic disorders, cancers, and addictive disorders[18][19] - The company's lead product candidate, narsoplimab, targets the lectin pathway of complement and is under review by the FDA and EMA for TA-TMA[19] - The press release contains forward-looking statements subject to a 'safe harbor' provision, and actual results could differ materially from expectations due to various risks outlined in SEC filings[20]