Omeros Corporation OMER on Thursday established the Omeros Oncology Clinical Steering Committee to advance Omeros’ OncotoX biologics program focused on acute myeloid leukemia (AML).AML is the most fatal form of leukemia. It accounts for approximately 80% of acute leukemias in adults and one-third of all cancers affecting the blood/bone marrow.Omeros’ OncotoX program for AML consists of proprietary targeted, engineered molecules (about half the size of an antibody) that deliver a toxic payload within the can ...

Financial Data and Key Metrics Changes - The net loss for Q4 2024 was $31.4 million, or $0.54 per share, compared to a net loss of $32.2 million, or $0.56 per share in Q3 2024 [6][58] - For the full year 2024, the net loss was $156.8 million, or $2.70 per share [6][58] - As of December 31, 2024, the company had over $90 million in cash and investments on hand [7][59] Business Line Data and Key Metrics Changes - Research and development expenses in Q4 were heavily focused on narsoplimab and Zaltenibart [59] - OMIDRIA royalties for Q4 totaled $10.1 million based on net sales of $33.6 million, an increase from $9.3 million in Q3 [63] Market Data and Key Metrics Changes - The market size for paroxysmal nocturnal hemoglobinuria (PNH) is reported to be $3.9 billion in 2023 and projected to exceed $10 billion by 2032 [36] Company Strategy and Development Direction - The company plans to independently launch narsoplimab in the U.S. while seeking partnerships for ex-U.S. commercialization [124][126] - The focus is on restructuring the balance sheet and exploring various funding options, including partnerships and royalty monetization [8][104] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strength of the data supporting the BLA resubmission for narsoplimab, highlighting significant survival benefits [77][78] - The company is preparing for the market launch of narsoplimab, with a strong foundation of awareness among transplant physicians [116] Other Important Information - The company is advancing Zaltenibart for C3 glomerulopathy and has received a rare pediatric disease designation from the FDA for this indication [46][47] - OMS527, aimed at treating addictions, has received funding from the National Institute on Drug Abuse for a Phase 1b clinical trial [52] Q&A Session Summary Question: Can you tell us why you believe the BLA submission is strong? - Management highlighted that the statistical analysis plan was created with FDA's agreement, and the results showed a more than three-fold improvement in survival for narsoplimab-treated patients [76][78] Question: Can you comment on pricing for narsoplimab? - Management indicated that pricing plans have not been disclosed but are expected to be in line with other complement inhibitors used in TA-TMA [91][92] Question: What is the strategy for funding and managing the balance sheet? - Management stated that they are aware of the need for balance sheet management and are exploring various options, including restructuring convertible notes and seeking additional capital [104][105] Question: Where does the company stand on manufacturing scalability for narsoplimab? - Management confirmed that they have sufficient drug supply to support the launch and initial market demand for narsoplimab [112] Question: How does the company view its long-term strategy regarding partnerships? - Management plans to launch narsoplimab independently in the U.S. while seeking partnerships for ex-U.S. commercialization, with a focus on leveraging their deep pipeline [124][126]

Product Development and Pipeline - Omeros Corporation's lead product candidate, Narsoplimab (OMS721), is focused on treating hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) and is currently in the process of resubmitting a Biologics License Application (BLA) to the FDA, with a target action date expected in September 2025[40]. - Omeros is developing zaltenibart (OMS906), a monoclonal antibody targeting MASP-3, for conditions such as paroxysmal nocturnal hemoglobinuria (PNH) and complement 3 glomerulopathy (C3G), with ongoing clinical trials[27]. - The clinical development pipeline includes OMS1029, a long-acting antibody targeting the lectin pathway, with Phase 1 studies completed and plans for Phase 2 development[34]. - The company is also advancing OMS527, a phosphodiesterase 7 (PDE7) inhibitor for addiction and movement disorders, with a Phase 1b study in adult cocaine use disorder patients initiated[28][34]. - Omeros has a diverse preclinical pipeline, including small-molecule inhibitors for MASP-2 and MASP-3, and therapies targeting a wide range of cancers[34]. - The company has generated positive preclinical data for MASP-2 inhibition in various disease models, indicating potential for significant therapeutic applications[37]. - The Phase 3 program for zaltenibart in PNH includes 120 clinical sites across 30 countries, with active comparator drug sourced and clinical site activation underway[59]. - Interim analysis from the Phase 2 trial of zaltenibart in PNH patients showed statistically significant improvements in hemolysis markers, including hemoglobin and lactate dehydrogenase[61]. - The ongoing Phase 2 clinical program for zaltenibart in C3G is expected to complete enrollment later this year, with plans for a Phase 3 trial contingent on efficacy results[64]. - The company received a $6.24 million grant from NIDA to develop the PDE7 inhibitor OMS527 for cocaine use disorder, funding a clinical study over three years[68]. - OMS527 demonstrated a reduction in adverse effects associated with cocaine in animal studies, indicating potential therapeutic benefits[69]. - The company received a funding commitment of $4.02 million from NIDA for a clinical trial assessing the safety and efficacy of the OMS527 compound, with preliminary data readout targeted by year-end 2025[70]. - In a Phase 1 clinical trial, the OMS527 compound was well tolerated with no safety concerns and showed favorable pharmacokinetics for once daily dosing[71]. - The company is evaluating an OMS527 PDE7 inhibitor for treating levodopa-induced dyskinesia (LID) in Parkinson's disease patients, with over 10 million patients affected globally[72]. - The PPARγ program has shown positive results in Phase 2 trials for addiction treatment, with significant reductions in cravings and anxiety reported[75]. Financials and Funding - The company received a milestone payment of $200 million from Rayner Surgical Inc. in February 2023 related to the sale of OMIDRIA, contingent upon its use in ambulatory surgery centers for at least four years[30]. - Omeros has entered into a Royalty Purchase Agreement with DRI Healthcare Acquisitions LP, receiving $125 million for a portion of the royalties from OMIDRIA sales, with an amended agreement in February 2024 eliminating annual caps on royalty payments[31][32]. - The company has borrowed approximately $67.1 million under a Credit and Guaranty Agreement, pledging substantially all assets as collateral, while maintaining a covenant to keep $25 million in unrestricted cash[33]. - As of December 31, 2024, the company had cash, cash equivalents, and short-term investments of $90.1 million, with cash used in operations amounting to $148.8 million and a net loss of $156.8 million for the year[170]. - The company has incurred cumulative operating losses since inception and may require additional capital to complete the development and commercialization of its product candidates[170]. - The company faces substantial doubt regarding its ability to continue as a going concern, which may materially adversely affect its share price and ability to raise new capital[169]. - The company expects to continue incurring additional losses until it generates significant revenue from commercial products or partnerships[171]. - If unable to raise additional capital, the company may have to delay, scale back, or discontinue the development of its product candidates[171]. - The company’s financial condition may limit its ability to access capital and could result in mandatory prepayments of the Initial Term Loan[171]. - The total aggregate principal amount of the company's 2026 Notes outstanding is $97.2 million, alongside $67.1 million under the Initial Term Loan and approximately $2.0 million of finance lease obligations[175]. Regulatory and Compliance - Narsoplimab has received breakthrough therapy designation and orphan drug designation from the FDA for multiple indications, including TA-TMA and complement-mediated TMAs[46]. - The European Medicines Agency confirmed narsoplimab's eligibility for centralized review, with a marketing authorization application targeted for submission in the first half of 2025[47]. - The FDA issued a Complete Response Letter (CRL) for the BLA of narsoplimab for TA-TMA, indicating the need for additional information to support regulatory approval[177]. - The regulatory environment for drug candidates is extensive, with compliance required for research, development, testing, and marketing[102]. - The FDA provides fast-track designation for drugs intended to treat serious diseases, expediting development and review processes[116]. - Breakthrough therapy designation allows for increased FDA interactions to expedite product development for serious conditions[117]. - Accelerated approval can be granted for drugs showing meaningful therapeutic advantages based on surrogate endpoints[119]. - Post-approval, the FDA requires confirmatory studies to verify clinical benefits of drugs granted accelerated approval[120]. - Orphan drug designation offers incentives for drugs treating rare diseases affecting fewer than 200,000 individuals in the U.S.[122]. - Pediatric exclusivity can extend market exclusivity by six months if pediatric studies are conducted as requested by the FDA[123]. - Expanded access allows investigational drugs to be used for patients with serious conditions when no satisfactory alternatives exist[125]. - The Drug Supply Chain Security Act mandates tracking and tracing obligations for manufacturers to ensure drug safety[129]. - The Hatch-Waxman Act provides exclusivity periods for new drugs, preventing generic applications for specified durations[135]. - The CREATES Act allows generic developers to sue brand manufacturers for access to necessary samples for product development[137]. - The company is subject to various federal and state healthcare compliance laws, including the Anti-Kickback Statute and the False Claims Act, which could impact its operations[141]. - The company operates in a highly regulated environment, with governments in the EU controlling the price of medicinal products through pricing and reimbursement rules[151]. - The company is subject to extensive government regulation, and failure to comply may result in significant penalties and operational disruptions[191]. - The company cannot guarantee timely FDA or EMA approval for narsoplimab or any other product candidates, which may require substantial time and resources[192]. Intellectual Property - As of March 31, 2025, the company owned or held exclusive licenses to a total of 81 issued patents and 64 pending patent applications in the U.S., and 1,443 issued patents and 655 pending patent applications in foreign markets[98]. - The MASP-2 program includes 42 issued patents and 33 pending patent applications in the U.S., and 861 issued patents and 474 pending patent applications in foreign markets, with patent terms expiring as late as 2043[98]. - The MASP-3 program has five issued patents and eight pending patent applications in the U.S., and 212 issued and 109 pending patent applications in foreign markets, with patent terms expiring as late as 2043[98]. - The PPARγ program includes three issued patents and one pending patent application in the U.S., and 42 issued patents and one pending patent application in foreign markets, with terms expiring as late as 2030[98]. - The PDE7 program has two issued patents and two pending patent applications in the U.S., and 61 issued patents and seven pending patent applications in foreign markets, with terms expiring as late as 2043[98]. - The oncology program has two patent applications pending in the U.S. related to potential cancer therapies[99]. - The company is operating its oncology program in stealth mode to confirm results and generate new data for intellectual property[99]. - Protecting intellectual property and proprietary technologies is challenging and costly, impacting the company's commercial success[218]. - The patent positions in the pharmaceutical and biotechnology sectors are uncertain, with potential changes in patent laws affecting the value of the company's intellectual property[219]. - The company cannot assure that its patent applications will be found patentable or that they will issue as patents, which could limit protection for its product candidates[220]. - The degree of future protection for proprietary rights is uncertain, and inability to maintain patent protection may hinder the development of follow-on indications[221]. Competition and Market Risks - The company expects to face competition from established pharmaceutical companies and new entrants in the biotechnology sector, which may impact market share[94]. - Narsoplimab and other product candidates will compete against several approved complement-targeted therapeutics, including Soliris and Ultomiris[96]. - The success of future products depends heavily on adequate coverage and reimbursement from government and private payers, which may be delayed or insufficient[180]. - The company faces significant risks in obtaining regulatory approvals outside the U.S., which may involve additional testing and data review[179]. - The operating results of the company are unpredictable and may fluctuate due to various factors, including market acceptance and pricing policies[187]. - The company may experience delays in obtaining coverage or reimbursement for newly approved products, impacting revenue and profitability[181]. - Changes in government regulations or reimbursement policies could adversely affect revenue generation and profitability[196]. - The company faces challenges in securing sufficient manufacturing capacity from contract manufacturers, which may lead to delays or inadequate supply[198]. - The availability of necessary ingredients and materials for manufacturing may not be guaranteed, potentially delaying commercialization[204]. - Clinical trials may be delayed due to various factors, including regulatory approvals and patient enrollment challenges[207]. - The company may need to establish additional manufacturing arrangements if current suppliers fail to meet requirements, which could be time-consuming and costly[199]. - There is a risk that product candidates may not successfully complete clinical development or be suitable for commercialization[212]. - The company must focus its limited resources on the most promising product candidates, potentially forgoing other opportunities[211]. Human Resources - The company had 202 full-time employees as of December 31, 2024, with 136 in research and development, 19 in sales and marketing, and 47 in finance, legal, business development, and administration[153]. - The company has built a research and development organization that includes expertise in discovery research, preclinical development, product formulation, analytical and medicinal chemistry, manufacturing, clinical development, and regulatory and quality assurance[152]. - The company is not substantially dependent on any third parties for its preclinical research and engages multiple clinical sites to conduct clinical trials[152]. - The company’s chief commercial officer has nearly three decades of international experience in the biopharmaceutical industry, having held leadership roles at various companies[157]. - The company’s vice president of chemistry, manufacturing, and controls has 20 years of pharmaceutical experience and has contributed to the commercialization of nine drug/device combination products[158].

Financial Performance - Net loss for Q4 2024 was $31.4 million, or $0.54 per share, compared to a net loss of $32.2 million, or $0.56 per share in Q3 2024[3]. - For the year ended December 31, 2024, net loss was $156.8 million, or $2.70 per share, compared to a net loss of $117.8 million, or $1.88 per share in the prior year[8]. - The company reported a net loss of $31.4 million for Q4 2024, compared to a net loss of $9.1 million in Q4 2023[21]. - The accumulated deficit increased to $910.3 million as of December 31, 2024, from $753.5 million a year earlier[23]. Cash and Investments - Cash and short-term investments available for operations and debt servicing as of December 31, 2024, were $90.1 million, a decrease of $81.7 million from December 31, 2023[9]. - Cash and cash equivalents were $3.4 million as of December 31, 2024, compared to $7.1 million at the end of 2023[23]. Revenue and Royalties - OMIDRIA royalties earned in Q4 2024 were $10.1 million on U.S. net sales of $33.6 million, compared to $9.3 million on U.S. net sales of $31.0 million in Q3 2024[10]. - Net income from discontinued operations was $5.2 million for Q4 2024, compared to $4.9 million in Q3 2024[12]. Operating Expenses - Total operating expenses for Q4 2024 were $35.7 million, slightly up from $35.4 million in Q3 2024[11]. - Significant cost outlays during 2024 totaled $42.7 million, including $21.7 million for repurchasing convertible senior notes and $19.1 million for narsoplimab drug substance delivery[9]. - Research and development expenses for Q4 2024 were $23.3 million, down from $28.9 million in Q4 2023[21]. - Selling, general and administrative expenses increased to $12.3 million in Q4 2024 from $10.9 million in Q4 2023[21]. - Interest expense decreased to $3.2 million in Q4 2024 from $4.1 million in the prior quarter, primarily due to the remeasurement of the OMIDRIA royalty obligation[11]. Drug Development and Regulatory Updates - The biologics license application (BLA) for narsoplimab was resubmitted to the FDA in March 2025, with a target action date of September 2025[4]. - The European marketing authorization application (MAA) for narsoplimab is expected to be submitted in the first half of 2025[3]. - The Phase 3 program for zaltenibart in treating paroxysmal nocturnal hemoglobinuria (PNH) has been initiated, including two studies targeting different patient populations[5]. - NIDA confirmed funding of $4.02 million for the OMS527 program, aimed at treating cocaine use disorder, starting April 1, 2025[6]. - Narsoplimab demonstrated a hazard ratio of 0.32 in overall survival compared to an external control population of TA-TMA patients, indicating significant clinical efficacy[4]. - Omeros' lead drug candidate, narsoplimab, is pending FDA review for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy[16]. Assets - Total assets decreased to $277.1 million as of December 31, 2024, down from $378.3 million a year earlier[23].

Group 1 - Omeros Corporation is set to release its fourth-quarter financial results on March 31, with analysts expecting a quarterly loss of 78 cents per share, compared to a loss of 69 cents per share in the same period last year [1] - On March 21, Omeros provided an update on its ongoing Zaltenibart Phase 3 PNH clinical trial program [1] - Omeros shares increased by 4.7%, closing at $8.92 on Thursday [1] Group 2 - Needham analyst Serge Belanger maintained a Hold rating on Omeros with an accuracy rate of 68% [4] - Cantor Fitzgerald analyst Olivia Brayer reiterated a Neutral rating on Omeros, achieving an accuracy rate of 62% [4]

Group 1 - Omeros Corporation (NASDAQ: OMER) faced a Complete Response Letter (CRL) for their HSCT-TMA molecule narsoplimab three years ago, leading to a significant decline in stock value, but it has recently shown signs of recovery [1] - The Total Pharma Tracker offers tools for DIY investors, including a software that provides extensive curated research material for any ticker [1] Group 2 - For investors seeking hands-on support, the in-house experts at Total Pharma Tracker analyze tools to identify the best investable stocks, along with buy/sell strategies and alerts [2] - A free trial is available for potential users to access the tools and evaluate the services offered by Total Pharma Tracker at no cost [2]

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]