Core Insights - Omeros Corporation announced the completion of the primary statistical analysis for narsoplimab, a monoclonal antibody targeting TA-TMA, in agreement with the FDA [1][4] - Narsoplimab demonstrated significant improvement in overall survival for TA-TMA patients compared to an external control group [3][2] - The company plans to resubmit the Biologics License Application (BLA) for narsoplimab for TA-TMA and aims for a European marketing authorization application submission in Q2 2025 [5] Company Developments - The independent statistical analysis compared 28 TA-TMA patients treated with narsoplimab in the OMS721-TMA-001 trial to over 100 high-risk TA-TMA patients who did not receive the treatment [2][4] - Narsoplimab achieved a hazard ratio of 0.32, indicating a clinically meaningful and statistically significant improvement in overall survival [3] - Narsoplimab has shown good tolerability and no safety concerns across all clinical trials conducted to date [5] Market Reaction - Following the announcement, Omeros' stock price increased by 54.8%, reaching $11.55 [7]

Financial Data and Key Metrics Changes - The net loss for Q3 2024 was $32.2 million or $0.56 per share, a decrease from a net loss of $56 million or $0.97 per share in Q2 2024, primarily due to a $17.6 million expense related to narsoplimab in Q2 [7][49] - Cash and investments as of September 30, 2024, totaled $123.2 million, a decrease of $35.8 million from June 30, 2024 [8][49] - Operating costs from continuing operations for Q3 were $35.4 million, down $23.8 million from Q2, driven by reduced R&D expenses [49] Business Line Data and Key Metrics Changes - OMIDRIA royalties for Q3 were $9.3 million, with net sales of $31 million, compared to royalties of $10.9 million and net sales of $36.4 million in Q2, indicating a decrease in both metrics [54] - The company expects to initiate HOPD sales for OMIDRIA starting January 1, 2025, which is anticipated to significantly increase sales in the U.S. [9][10] Market Data and Key Metrics Changes - The market size for PNH is reported to be $3.9 billion in 2023 and projected to exceed $10 billion by 2032, indicating a growing opportunity for zaltenibart [32] Company Strategy and Development Direction - The company is focused on the resubmission of the Biologics License Application (BLA) for narsoplimab in TA-TMA, with expectations for a quick turnaround following FDA feedback [11][15] - Omeros is advancing its zaltenibart program with plans for Phase 3 trials in PNH and C3G, with a clear path established through discussions with FDA and European regulators [28][29] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential for commercial sales of narsoplimab in 2025, contingent on successful BLA resubmission [60] - The company is preparing for the initiation of Phase 3 trials for zaltenibart, with a focus on patient enrollment and leveraging previous positive data [75] Other Important Information - The FDA has established a rare disease innovation hub to facilitate the development of treatments for rare diseases, which may benefit Omeros' programs [17] - The company is also exploring additional indications for its MASP-3 inhibitor, zaltenibart, and has received a rare pediatric disease designation for C3G [33][34] Q&A Session Summary Question: Expectations for narsoplimab commercial sales - Management hopes to have narsoplimab commercially available in 2025, pending alignment on the statistical analysis plan with the FDA [60] Question: Phase 3 trial designs for zaltenibart - The Phase 3 trials will include a switch-over trial for patients not responding to ravulizumab and a trial for treatment-naive patients, with positive feedback received from regulatory agencies [66][68] Question: Strategy for the priority review voucher for pediatric C3G - Management indicated it is premature to discuss strategy regarding the voucher, considering market interest and potential internal use [69] Question: Size and cost estimates for OMS906 Phase 3 program - The Phase 3 studies are expected to be relatively small, with around 100 patients per trial, and management is confident in moving forward independently while exploring partnership opportunities [74][75]

Financial Performance - Net loss from continuing operations for the three months ended September 30, 2024, was $37.1 million, compared to a loss of $51.7 million for the same period in 2023, representing a 28.2% improvement [12]. - The company reported a net loss of $32.2 million for the three months ended September 30, 2024, compared to a net loss of $37.8 million for the same period in 2023, reflecting a 14.6% decrease [12]. - Total costs and expenses for the nine months ended September 30, 2024, were $133.6 million, an increase of 7.1% from $124.8 million for the same period in 2023 [12]. - Cash used in operations for the nine months ended September 30, 2024 was $119.8 million, which includes an $18.4 million charge for delivery of narsoplimab drug substance [163]. - The company reported a net loss of $32.2 million and $125.5 million for the three and nine months ended September 30, 2024, respectively [163]. Cash and Investments - Cash and cash equivalents at the end of the period were $1.5 million, down from $30.6 million at the end of September 2023 [17]. - The company has $123.2 million in cash, cash equivalents, and short-term investments as of September 30, 2024, with cash used in operations amounting to $119.8 million for the nine months ended September 30, 2024 [32]. - Total short-term investments amounted to $121.640 million as of September 30, 2024, with U.S. government securities and money-market funds comprising the majority [56]. - As of September 30, 2024, the company had cash, cash equivalents, and short-term investments of $123.2 million available to fund operations and service debt [146]. Research and Development - Research and development expenses for the three months ended September 30, 2024, were $24.1 million, down 24.1% from $31.7 million in the same period of 2023 [12]. - The company is focused on developing first-in-class therapeutics targeting immunologic disorders, cancers, and addictive disorders [19]. - The company is developing narsoplimab (OMS721) for TA-TMA, having completed a pivotal clinical trial and submitted a BLA to the FDA [117]. - Narsoplimab shows potential as a therapeutic for COVID-19 and ARDS, supported by in vivo animal data and proof-of-concept clinical data [118]. - OMS1029, a long-acting antibody targeting MASP-2, has completed Phase 1 trials, confirming once-quarterly low-volume dosing with no safety concerns [119]. - Zaltenibart, targeting MASP-3, is advancing to Phase 3 trials for PNH and C3G, with multiple ongoing Phase 2 trials [120][121]. - The Phase 2 trial for zaltenibart in patients unsatisfied with ravulizumab showed significant improvements in hemoglobin levels and reticulocyte counts [124]. Debt and Financing - The company entered into a Credit Agreement providing for a senior secured term loan facility of up to $92.1 million, with an initial term loan of $67.1 million [29]. - The company repurchased $118.1 million of its existing 5.25% convertible senior notes due in 2026, resulting in a $51.0 million reduction in outstanding debt [30]. - The Initial Term Loan amount outstanding was $67,077,000 as of September 30, 2024, with a total long-term debt of $92,427,000 [67]. - The company accrued $0.6 million in additional cash consideration to a certain Lender as a post-closing adjustment under the 2026 Note Repurchase Transaction [66]. - The company has a sales agreement to sell shares of common stock for up to $150.0 million to raise additional capital [34]. Discontinued Operations - The company has classified the results of OMIDRIA activities as discontinued operations following its sale to Rayner Surgical Inc. [26]. - The company recognized net income from discontinued operations of $4.881 million for the three months ended September 30, 2024, compared to $13.906 million for the same period in 2023, a decrease of approximately 65% [90]. - Cash provided by discontinued operations from operating activities was $30.619 million for the nine months ended September 30, 2024, significantly lower than $232.081 million for the same period in 2023 [92]. Stock and Compensation - Stock-based compensation expense for the nine months ended September 30, 2024, was $8.1 million, compared to $9.0 million for the same period in 2023 [17]. - The total estimated compensation expense yet to be recognized on outstanding options is $14.4 million [111]. - The share repurchase program authorized up to $50 million, with 5 million shares repurchased at an average price of $3.30 per share [105]. - As of September 30, 2024, there were 18.13 million stock options outstanding, with a weighted average exercise price of $8.41 per share [110]. Future Outlook - The company plans to resubmit the BLA for narsoplimab following FDA feedback expected in November 2024 [117]. - The company expects research and development expenses in Q4 2024 to be similar to those in Q3 2024 [151]. - The company anticipates that selling, general and administrative expenses in Q4 2024 will be similar to those in Q3 2024 [154]. - The company expects to initiate Phase 3 trials for C3G in the first half of 2025, following ongoing Phase 2 trials [127].

Financial Performance - Net loss for Q3 2024 was $32.2 million, or $0.56 per share, compared to a net loss of $37.8 million, or $0.60 per share in Q3 2023[1] - Net loss from continuing operations for Q3 2024 was $37,113,000, compared to a loss of $51,656,000 in Q3 2023, reflecting a 28% improvement[31] - The company reported a net loss of $32,232,000 for Q3 2024, which is a 15% decrease from the net loss of $37,750,000 in Q3 2023[31] Cash and Investments - Cash and short-term investments available for operations and debt servicing were $123.2 million, a decrease of $48.7 million from December 31, 2023[2] - Cash and cash equivalents decreased to $1,521,000 as of September 30, 2024, down from $7,105,000 at the end of 2023[33] - Total current assets were $164,921,000 as of September 30, 2024, a decline from $217,898,000 at the end of 2023[33] - Total assets decreased to $313,335,000 as of September 30, 2024, compared to $378,269,000 at the end of 2023[33] - The accumulated deficit increased to $(878,987,000) as of September 30, 2024, from $(753,530,000) at the end of 2023[33] Operating Expenses - Total operating expenses for Q3 2024 were $35.4 million, down from $48.2 million in Q3 2023, primarily due to reduced clinical expenditures[22] - Research and development expenses for Q3 2024 were $24,084,000, a decrease of 24% from $31,731,000 in Q3 2023[31] - Selling, general and administrative expenses for Q3 2024 were $11,323,000, down 31% from $16,422,000 in Q3 2023[31] - Total costs and expenses for Q3 2024 were $35,407,000, a reduction of 26% compared to $48,153,000 in Q3 2023[31] - Interest expense decreased to $4.1 million in Q3 2024 from $7.9 million in the prior year quarter due to retiring convertible notes[23] Product Development and Regulatory Updates - Narsoplimab BLA resubmission is anticipated following a productive FDA presubmission meeting, with plans to conduct primary and secondary efficacy analyses[3] - European MAA for narsoplimab is expected to be submitted in the first half of 2025[4] - Zalatenibart is advancing to Phase 3 enrollment in PNH, expected in early 2025, following successful meetings with FDA and European regulators[5] - OMS1029 has completed Phase 1 studies and is being evaluated for Phase 2 clinical development in large-market indications[12] - OMS527, targeting cocaine use disorder, is set to initiate a randomized clinical study next year, funded by a $6.69 million NIDA grant[17] - The company is advancing its lead MASP-2 inhibitor narsoplimab, with a biologics license application pending before the FDA[29] Revenue from Products - OMIDRIA royalties earned were $9.3 million on U.S. net sales of $31.0 million, compared to $10.0 million on U.S. net sales of $33.3 million in Q3 2023[21]

Financial Data and Key Metrics Changes - The net loss for Q2 2024 was $56 million or $0.97 per share, compared to a net loss of $37.2 million or $0.63 per share in Q1 2024 [4][26] - Total cash and investments on hand as of June 30, 2024, were $158.9 million, a decrease of $71.4 million from March 31, 2024 [6][27] - Costs and expenses from continuing operations for Q2 were $59.2 million, an increase of $20.1 million from Q1 2024 [28] Business Line Data and Key Metrics Changes - R&D expenses in Q2 included $17.6 million related to the manufacture of narsoplimab drug substance lots [5][26] - The company incurred $21.2 million in discounted term loan related debt repurchase and $1.9 million in transaction costs [5][27] - OMIDRIA royalties for Q2 were $10.9 million on net sales of $36.4 million, compared to $9.4 million on net sales of $31.2 million in Q1 2024 [29][30] Market Data and Key Metrics Changes - The company has two sales contingent milestones from the sale of OMIDRIA royalties, each up to $27.5 million, payable in January 2026 and January 2028 [6][30] - The debt repurchase transaction reduced the outstanding 2026 notes by 55% from $216 million to $98 million [7][32] Company Strategy and Development Direction - The company is focused on obtaining FDA approval for narsoplimab and is preparing for its resubmission [11][12] - The development program for zaltenibart (MASP-3 inhibitor) is advancing with multiple Phase 2 studies ongoing [13][16] - The company is exploring chronic large value indications for OMS1029, including neovascular age-related macular degeneration [20][21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the data supporting narsoplimab's approval and is actively engaging with the FDA [38][41] - The company is well-prepared for commercialization upon receiving regulatory approval, with plans in place for packaging and branding [39][40] - Management highlighted the need for FDA approval as the primary requirement to move forward with narsoplimab [38][41] Other Important Information - The term loan agreement includes a $25 million delayed draw facility contingent on FDA approval of narsoplimab [9][31] - The company is developing a diagnostic approach for MASP-2 and lectin pathway hyperactivation to drive adoption of narsoplimab [22] Q&A Session Summary Question: Can you provide insights on future expenses? - Management clarified that the significant expenses incurred in Q2 are not expected to be repeated in the future [36] Question: What is needed for market entry post-approval? - Management indicated that FDA approval is crucial, and they are well-prepared for commercialization [38][40] Question: When is the additional FDA meeting expected? - The date of the meeting was not specified, but it involves responses to FDA questions [46] Question: What is the status of zaltenibart and C3G program? - The Phase 2 study is ongoing, and there is an expectation of overlap between Phase 2 and Phase 3 trials [53][54] Question: How quickly can OMS1029 enter the clinic? - If data is favorable, the company anticipates moving into the clinic in early 2025 [55]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the prece ...

Exhibit 99.1 Omeros Corporation Reports First Quarter 2024 Financial Results – Conference Call Today at 4:30 p.m. ET SEATTLE, WA – May 15, 2024 – Omeros Corporation (Nasdaq: OMER), a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting immunologic disorders including complement-mediated diseases, cancers, and addictive and compulsive disorders, today announced recent highlig ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to Commission file number: 001-34475 OMEROS CORPORATION (Exact name of registrant as specified in its charter) Washington 91-1663741 ...

Exhibit 99.1 Omeros Corporation Reports Fourth Quarter and Year-End 2023 Financial Results – Conference Call Today at 4:30 p.m. ET SEATTLE, WA – April 1, 2024 – Omeros Corporation (Nasdaq: OMER), a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting immunologic disorders including complement-mediated diseases, cancers, and addictive and compulsive disorders, today announced ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 or Washington 91-1663741 (State or other jurisdiction of incorporation or organization) 201 Elliott Avenue West Seattle, Washington 98119 (Address of principal executive offices) (Zip Code) Identification Number) (206) 676-5000 (Registrant's telephone number, i ...