Omeros (NASDAQ:OMER) Corporation (NASDAQ: OMER), a biopharmaceutical company, reported a reduced net loss of $32.2 million for the third quarter of 2024 compared to the previous quarter's $56 million loss. The company's cash reserves stood at $123.2 million as of September 30, 2024. A deal with DRI Healthcare over OMIDRIA royalties is expected to bring potential milestone payments.
Omeros is preparing to resubmit its Biologics License Application for narsoplimab and anticipates starting Phase 3 trials for its promising drug zaltenibart in early 2025. The company also expects stable operating costs and income from discontinued operations in the range of $7 million to $8 million for the fourth quarter.
Key Takeaways
- Omeros Corporation reported a Q3 2024 net loss of $32.2 million, a decrease from Q2's $56 million loss.
- Cash reserves were at $123.2 million, down from the previous quarter.
- Sale of OMIDRIA royalties to DRI Healthcare includes potential milestones in 2026 and 2028.
- Separate payments for OMIDRIA from CMS are expected to boost sales starting January 2025.
- Resubmission of the BLA for narsoplimab is in progress, with a European MAA submission planned for the first half of 2025.
- Zaltenibart, for PNH and C3G, is advancing with Phase 3 trials expected to start in early 2025.
- Financial outlook for Q4 includes stable operating costs and income from discontinued operations of $7 million to $8 million.
Company Outlook
- Omeros expects stable operating costs going into Q4 2024.
- The company projects income from discontinued operations to be between $7 million and $8 million for the upcoming quarter.
- Omeros is preparing to resubmit the BLA for narsoplimab, following collaborative discussions with the FDA.
- A European MAA submission for narsoplimab is planned for the first half of 2025.
- Phase 3 trials for zaltenibart are expected to begin in early 2025, with a focus on enrollment.
Bearish Highlights
- The company's cash reserves decreased by $35.8 million from the previous quarter.
- OMIDRIA royalties for Q3 amounted to $9.3 million with net sales of $31 million, a decrease from Q2's $10.9 million in royalties and $36.4 million in net sales.
Bullish Highlights
- Omeros announced a deal with DRI Healthcare for OMIDRIA royalties, including potential milestone payments.
- CMS confirmed separate payments for OMIDRIA, which is expected to increase sales.
- Zaltenibart has received rare pediatric disease designation for C3G, potentially expediting future approvals.
- The market for PNH is projected to grow significantly, providing a strong market potential for zaltenibart.
Misses
- Interest and other income for Q3 was $2.3 million, lower than the previous quarter due to reduced cash balances.
Q&A Highlights
- Serge Belanger asked about the OMS906 Phase 3 program's size, cost, and the company's ability to fund it.
- CEO Gregory Demopulos expressed confidence in advancing the program independently, citing strong data and a compelling safety profile.
- The planned studies for OMS906 will be randomized, enrolling slightly below 100 patients each.
- Steven Whitaker noted the efficacy observed in earlier studies, suggesting quick patient enrollment.
- Demopulos mentioned an encouraging recent FDA meeting and anticipates resubmitting the BLA soon.
InvestingPro Insights
Omeros Corporation's financial landscape, as revealed by InvestingPro data, offers additional context to the company's recent earnings report. With a market capitalization of $327.4 million, Omeros is trading near its 52-week high, with the current price at 73.77% of that peak. This aligns with the company's reported progress on key drug developments and strategic deals.
InvestingPro Tips highlight that Omeros has been aggressively buying back shares, which could be seen as a sign of management's confidence in the company's future prospects. This is particularly noteworthy given the company's significant debt burden and the fact that it's quickly burning through cash, as mentioned in the earnings report.
The company's high shareholder yield, another InvestingPro Tip, may be attractive to investors, especially considering the strong 181.21% price total return over the past year. However, it's important to note that Omeros does not pay a dividend to shareholders, focusing instead on reinvesting in its drug development pipeline.
Financial metrics from InvestingPro reveal that Omeros has a negative P/E ratio of -1.18 (adjusted for the last twelve months as of Q2 2024), reflecting its current unprofitability. This is consistent with the article's mention of the company's net losses. The negative gross profit of -$85.64 million and operating income of -$186.11 million further underscore the challenges Omeros faces in achieving profitability, a common situation for biopharmaceutical companies investing heavily in R&D.
For investors seeking a more comprehensive analysis, InvestingPro offers 11 additional tips for Omeros, providing a deeper understanding of the company's financial health and market position.
Full transcript - Omeros Corporation (OMER) Q3 2024:
Operator: Good afternoon, and welcome to today's conference call for Omeros Corporation. At this time, all participants are in a listen-only mode. After the company's remarks, we will conduct a question-and-answer session. [Operator Instructions]. Please be advised that this call is being recorded at the company's request and a replay will be available on the company's website for one week from today. I will now turn the call to Jennifer Williams, Investor Relations for Omeros.
Jennifer Cook Williams: Good afternoon, and thank you for joining the call today. I'd like to remind you that some of the statements that will be made on the call today will be forward-looking. These statements are based on management's beliefs and expectations as of today only and are subject to change. All forward-looking statements involve risks and uncertainties that could cause the company's actual results to differ materially. Please refer to the special note regarding forward-looking statements in the company's quarterly report on Form 10-Q, which was filed today with the SEC, and the Risk Factors section of the company's most recent annual report on Form 10-K and its subsequently filed quarterly reports for a discussion of these risks and uncertainties. Now I would like to turn the call over to Dr. Greg Demopulos, Chairman and CEO of Omeros.
Gregory Demopulos: Thank you, Jennifer, and good afternoon, everyone. I'm joined on today's call by our Chief Accounting Officer, David Borges; and Nadia Dac, our Chief Commercial Officer; Andreas Grauer, our Chief Medical (TASE:PMCN) Officer; our Chief Regulatory Officer, Cathy Melfi; and our Vice President of Clinical, Steve Whitaker. We'll start today with an overview and discussion of our third quarter 2024 financial results, followed by an update on our ongoing development programs. David will then provide a more detailed financial summary before we open the call to questions. Now let's look at our financial results for the third quarter. Our net loss for the third quarter of 2024 were $32.2 million or $0.56 per share compared to a net loss of $56 million or $0.97 per share in the second quarter of this year. The $23.8 million quarter-over-quarter decrease in the net loss was primarily driven by $17.6 million of narsoplimab drug substance recorded as an expense in the second quarter. As of September 30, 2024, we had $123.2 million of cash and investments on hand, a decrease of $35.8 million from June 30, 2024. In addition, as relayed in earlier calls, our recent sale of OMIDRIA royalties to DRI Healthcare carries with it two sales contingent milestones payable by DRI to Omeros, each up to $27.5 million with payment dates in January 2026 and January 2028. Earlier this year, the Centers For Medicare and Medicaid Services issued their outpatient prospective payment system final rule confirming ongoing separate payment for OMIDRIA in ambulatory surgery centers and for the first time beginning on January 1, 2025 expanding separate payment to hospital outpatient departments or HOPDs. The initiation of HOPD sales in January is expected to grow OMIDRIA sales meaningfully in the U.S. Ex-U.S. sales should also begin next year with Omeros receiving 15% of those net revenues. Additionally, our term loan agreement from June 2024 includes a commitment by the lenders to fund a $25 million delayed drop facility upon our request prior to June 3, 2025, contingent on receipt of FDA approval of narsoplimab in TA-TMA within 30 days of the funding request. The additional term loan commitment provides Omeros with a ready source of capital to fuel the early commercialization of narsoplimab. With that, let's move on to an update on our development program starting with our complement franchise and narsoplimab, our first-in-class MASP-2 inhibitor, targeting the effector enzyme of the lectin pathway of complement. As described in previous updates, we have been working closely with FDA regarding the anticipated resubmission of our Biologics License Application, or BLA for narsoplimab in hematopoietic stem cell transplant associated thrombotic microangiopathy, or TA-TMA. Over the last several quarters, we have had a series of interactions with the agency focused on our proposed plan for resubmission. In September, we held a pre-submission meeting with FDA. The meeting was collaborative and as part of the meeting, we received additional minor feedback on our proposed statistical analysis plan for the primary endpoint that being patient survival in our pivotal narsoplimab trial compared to that in an external registry of patients with TA-TMA. FDA had previously reviewed the plan and all FDA comments had been incorporated. The additional feedback was limited to requesting a few more sensitivity analyses. We quickly incorporated additional sensitivity analyses into the plan and sent it back to the agency. We are awaiting FDA's reply and expect it to arrive imminently. We have no other pending information requests and are not aware of any other impediments to resubmitting our narsoplimab BLA. Once FDA's response is in hand and assuming general alignment on the revised analysis plan, our independent external statistics group will conduct the pre-specified analyses directed to the primary endpoint. In addition to the primary analyses, the external statistics group will perform supplementary analyses on the narsoplimab Expanded Access Program or EAP together with sensitivity analyses and descriptive statistics on both the narsoplimab pivotal trial results and the narsoplimab EAP data. The key statistical programs for these analyses are already written, so results from the analyses should be available in a matter of days after their initiation. Following completion of the analyses, we look forward to sharing the results publicly. To accelerate the timeline to resubmission, preparations including drafting and revising sections of the resubmission began months ago. Assuming overall favorable analysis results, we will dedicate the necessary internal and external resources to resubmit the BLA as quickly as possible. Our recent interactions with FDA are occurring against a backdrop of heightened awareness and focus within both the agency and Congress on the need for expanding treatments for rare diseases, including increasing regulatory flexibility and FDAs review and approval process for these treatments. This is evidenced by public statements and congressional testimony by FDA leadership, the Congressional Rare Disease Caucus' communications with FDA as well as published editorials authored by the caucuses' bipartisan chairs and significant stakeholder engagement among highly credible rare disease community organizations. Perhaps most impactful and widely noted is FDAs recent and well received establishment of its rare disease innovation hub. The hub, co led by the Directors of FDA's Centers for Drug and for Biologics Evaluation and Research is designed to provide drug sponsors and other stakeholders in the rare disease community with a single point of connection and engagement within the FDA. The objective is to ensure greater consistency in the review process and to overcome and mitigate the unique challenges associated with developing therapeutics for rare diseases. Separate from our interactions with FDA, we are preparing a European Marketing Authorization Application or MAA for narsoplimab in TA-TMA, which we expect to submit in the first half of 2025. In parallel with our efforts to submit both the narsoplimab BLA and MAA, panels of international experts are preparing two manuscripts for publication in top tier peer reviewed journals. The first in keeping with our primary endpoint for regulatory approval, we'll compare survival of patients in our pivotal TA-TMA trial with the same rigorous external control used for our BLA resubmission. The second details the survival data in nearly 140 narsoplimab treated adult and pediatric patients from our global expanded access program. As we have moved closer to resolving the status and direction of our narsoplimab program in TA-TMA, we have in parallel continued to advance rapidly toward the initiation of Phase 3 clinical programs for zaltenibart also known as OMS906, our first in class MASP-3 inhibitor targeting the key activator of the alternative pathway of complement. Let's turn now to an update on our progress across our zaltenibart development programs. Omeros' focus for zaltenibart has been on multiple Phase 2 studies assessing the drug as a potential treatment for two chronic rare disease indications, paroxysmal nocturnal hemoglobinuria, or PNH, a life threatening hematologic disorder and C3 Glomerulopathy, or C3G, a debilitating and potentially life threatening kidney disease. Let's first discuss our PNH program, which continues advancing rapidly and generating compelling data. Our Phase 2 switchover study evaluated zaltenibart in PNH patients with a suboptimal response to ravulizumab. As planned and on schedule, all patients have now completed the trial with the last patient visit having occurred in October. These completed study patients have rolled into the long-term open label extension study further building our safety database to be included in the planned BLA for zaltenibart in PNH. Patients in the switch-over study began by receiving both zaltenibart and ravulizumab, a C5 inhibitor, with those patients demonstrating a response to the combination therapy then switching to zaltenibart monotherapy. The trial evaluated two zaltenibart dose levels. Results from the adjunctive therapy portion of the trial were presented in June at the Annual Congress of the European Hematology Association. Patients receiving ravulizumab and zaltenibart combination therapy demonstrated a statistically significant improvement both in mean hemoglobin compared to baseline and in absolute reticulocyte count. Now data from the zaltenibart monotherapy stage of the trial will be presented next month in San Diego at the Annual Congress of the American Society of Hematology. We are pleased with the results. Zaltenibart monotherapy prevented intravascular as well as extravascular hemolysis and showed sustained and clinically meaningful improvements in both hemoglobin levels and absolute reticulocyte counts. Zaltenibart also continues to demonstrate a favorable safety profile with no observed safety signal of concern. The second PNH study is ongoing, this one evaluating zaltenibart in PNH patients who have not been previously treated with a complement inhibitor. As discussed during last quarter's earnings call, we amended this study's protocol to allow zaltenibart concentrations in patients to decrease until breakthrough hemolysis occurred, generating additional data on the level of MASP-3 inhibition and the correlating plasma concentrations of zaltenibart required to inhibit that breakthrough hemolysis. Based on our analyses of these and other data generated from our zaltenibart clinical program and having agreed with both FDA and European regulators on our dose finding methodology, we've now selected the zaltenibart dose for our Phase 3 clinical trials. Both zaltenibart studies in PNH, the switch-over trial and the trial in treatment naive patients have resulted in impressive efficacy and safety data. These data support our expectation that zaltenibart will be a successful competitor in the market of alternative pathway therapeutics. And our Phase 3 program design is well aligned with that of our already successful Phase 2 program. Specifically, our Phase 3 program consists of two trials: one switch-over trial in patients with an inadequate response to C5 inhibitors and the other trial in patients who are not receiving complement inhibitor treatment. The endpoint measures are the same as those used by Novartis (SIX:NOVN) in its pivotal trials for Fabhalta and the results of our already conducted zaltenibart PNH trials show robust efficacy against those measures. So we're pleased to say that zaltenibart Phase 3 program in PNH is underway. Earlier this quarter, we completed successful end of Phase 2 meetings with both FDA and European regulators. Both agencies agreed with the designs of our studies. FDA had a few comments, which we incorporated and the revised protocols will be returned to FDA within the next few weeks. Based on our discussions with both FDA and European regulators, we now have a clear path to opening enrollment, which given the upcoming December holidays, we expect in early 2025. In preparation for commercialization, we also held a successful meeting with the German Federal Joint Committee or G-BA, the decision making body in the German health care system that specifies which medical treatments are reimbursed by the statutory health insurance funds. The G-BA provided us with productive feedback on the patient reported outcome member measures that we plan to incorporate in our trials. We also continue to solicit input from physicians and patients through market research and advisory boards to define the data that will meaningfully differentiate zaltenibart from other complement inhibitors. We are collecting these data in our Phase 3 trials and other non-trial activities. Based on the insights collected to date, zaltenibart's clinical profile together with its low treatment burden of only four to six times per year is clearly differentiated from treatment options on the market or in development. The market size for PNH is large and growing, reported to be $3.9 billion in 2023 and projected at over $10 billion in 2032. We expect that after approval, zaltenibart will command a substantial portion of that market given its differentiated profile that resonates well with prescribers and patients. Let's turn now to zaltenibart and C3 glomerulopathy, or C3G, an ultrarare kidney disease commonly affecting children. Late last month, we announced that FDA had awarded zaltenibart with a rare pediatric disease designation for the treatment of C3G. Companies holding a drug with this designation receive a rare pediatric disease priority review voucher from FDA when the designated drugs first approval is for the associated indication in the pediatric population. The voucher allows the recipient company to obtain FDA priority review of either a BLA or a new drug application for a different product or indication. This priority review is commercially valuable in that it reduces the review time and can accelerate any subsequent market entry by at least four months. The voucher may be used by the original recipient or can be sold to another company for use. Our zaltenibart Phase 2 C3G study is enrolling and assuming positive data. A Phase 3 program in C3G is planned for initiation in the first half of 2025. As discussed at our last quarterly call, all zaltenibart drug product needed for our Phase 3 programs has been manufactured and is ready and waiting for the start of enrollment in the Phase 3 PNH and C3G trials. As noted earlier, Omeros will have a sizable presence at the Annual Meeting of the American Society of Hematology next month, including zaltenibart abstract presentations, advisory board and medical affairs activities and meetings with experts and corporate groups across the relevant therapeutic areas for alternative pathway inhibition. So where do we go next with zaltenibart? Well, we continue to follow closely the clinical trial results of other alternative pathway inhibitors to identify additional indications where we believe zaltenibart would have substantial advantages over other agents. We also are exploring diseases for which the pathology might well be primarily MASP-3 driven. All this is to say that we remain keenly focused on the wide applicability of MASP-3 inhibition and the significant advantages that zaltenibart could hold over other alternative pathway targeting therapeutics on the market or in development, specifically more consistent efficacy, better safety and superior dosing compliance and convenience with significantly lower treatment burden, particularly when compared to twice or thrice daily oral medications that are often difficult for patients to remember to take. Closing out our discussion on Omeros' franchise of complement therapeutics, let's look at OMS1029, our next generation long acting MASP-2 inhibitor. Having successfully completed both the single and multiple ascending dose Phase 1 studies of OMS1029, we are confident that the drug can effectively ablate MASP-2 concentrations in humans with once quarterly low volume dosing, whether administered subcutaneously or intravenously. We also believe that the safety profile of OMS1029 is compelling. Having seen no safety concerns with OMS1029 nor across any of the clinical trials with its shorter acting relative, the MASP-2 inhibitor narsoplimab. We continue our assessment of attractive indications for OMS1029 as well as of additional indications for narsoplimab dependent, of course, on resource availability. We also are continuing our work with narsoplimab and MASP-2 inhibition in both severe acute and long COVID as well as in acute respiratory distress syndrome, or ARDS, including H1N1 and H5N1. Here again, manuscripts detailing the study results are being prepared for submission to top tier peer reviewed journals. In addition to our complement antibodies, narsoplimab, zaltenibart and OMS1029, we continue making headway on our small molecule orally available MASP-2 and MASP-3 inhibitor programs for use in large market chronic indications. Let's turn briefly now to OMS527, our PDE7 inhibitor program aimed at treating addictions, compulsions as well as movement disorders. Our ongoing work to develop OMS527 as the first treatment for cocaine use disorder remains fully funded by the National Institute on Drug Abuse, or NIDA. We continue to expect results later this year from our toxicology study in primates and rodents exposed to both cocaine and OMS527 to assess potential drug, drug interactions. Assuming satisfactory results, the next step is to begin in 2025 enrolling a randomized double blind inpatient clinical trial evaluating OMS527 in individuals with cocaine use disorder. This clinical trial will also be fully funded by NIDA. Also, as previously discussed, we are exploring the potential use of OMS527 in movement disorders, specifically levodopa induced dyskinesias or LID. This is a profound and highly prevalent problem in patients with Parkinson's disease caused not by the disease, but rather by its treatment. We are pursuing substantial external funding for the further development of OMS527 in LID, a large and essentially unaddressed market. Finally, we'll conclude today's program review with our first in class therapeutic platform of molecular and cellular programs targeting a wide range of therapeutic areas, including cancer. Building on our understanding of immunity, both innate or complement mediated and adaptive, meaning B-cells as well as CD4 and CD8 T-cells, our objective is to move beyond existing targeted biologics such as antibody drug conjugates and radioligands and also beyond immunotherapies like checkpoint inhibitors and CAR T. To achieve this, we are developing a portfolio of signaling driven immunomodulators, oncotoxins, and an adoptive T-cell technology combined with an immunostimulator. The T-cell therapy and immunostimulator combination, unlike other cellular therapy approaches, requires no cellular engineering, reduces manufacturing costs and timelines, and maintains an enhanced anticancer immune response by means of simple and repetitive therapeutic administrations. Our growing volume of in vitro and in vivo data support the potential to deliver broadly effective and safe cancer therapies that can overcome the shortcomings of currently marketed therapeutics by treating both hematological and solid tumors, targeting both cell surface and intracellular cancer antigens, and increasing levels of CD4 and CD8 cancer antigen specific effector and memory cells. We are rapidly advancing our oncology programs in stealth development, while we continue to expand our intellectual property position. Over the past several months, we have sought the input and guidance of therapeutic area experts and advisors under confidentiality with uniformly positive response. Over the past few days, we began raising the visibility of these programs at international Congresses holding non-confidential discussions with academic experts and corporate groups in Houston at the Annual Meeting of the Society of Immunotherapy of Cancer. As previously mentioned, our team will also be attending the upcoming meeting of the American Society of Hematology. We plan to share further information on these programs publicly in the coming months. I'll now turn the call over to David Borges, our Chief Accounting Officer, to go through a more detailed discussion of our financial results. David?
David Borges: Thanks, Greg. Our net loss for the third quarter of 2024 was $32.2 million or $0.56 per share compared to a net loss of $56 million or $0.97 per share in the second quarter of 2024. As of September 30, 2024 we had $123.2 million of cash and investments on hand, a decrease of $35.8 million from June 30, 2024. Cost and expenses from continuing operations for the third quarter were $35.4 million which was a decrease of $23.8 million from the second quarter of this year. The decrease was primarily driven by $17.6 million of R&D expense related to the manufacture of narsoplimab drug substance lots that commenced in October 2023, and which were delivered and expensed in the second quarter of this year. Recall that our accounting policy is to expense all manufacturing costs related to drug candidates until regulatory approval is reasonably assured in either the U.S. or the European Union. Manufacturing costs for zaltenibart were lower by $3.7 million in the third quarter as a result of drug substance produced and expense in the second quarter. In addition, there were $1.9 million for term loan related transaction costs that were expensed in the second quarter of 2024. Interest expense for the third quarter was $4.1 million which was $5.2 million lower than the second quarter of this year. The primary drivers of interest expense are the 2026 notes, the DRI-OMIDRIA royalty obligation and the newly issued secured term loan entered into in June 2024. In the third quarter, we recorded a $3.4 million non-cash credit lowering interest expense reflecting changes made to the OMIDRIA royalty obligation. The remaining third quarter decrease was due to newly issued secured term loan agreement, which replaced a portion of our 26 notes. Interest and other income for the third quarter was $2.3 million. This is lower than the second quarter of this year due to lower cash balances to invest. And income from discontinued operations in the third quarter of this year was $4.9 million and includes two primary components. First, $4.2 million of interest earned on the OMIDRIA contract royalty asset and second $700,000 of remeasurement adjustments to the OMIDRIA contract royalty asset. As we have previously discussed, royalties earned are recorded as a reduction in the OMIDRIA contract royalty asset on our balance sheet and not in our income statement. OMIDRIA royalties for the third quarter were $9.3 million and OMIDRIA net sales of $31 million. This is compared to royalties of 10.9 million on second quarter net sales of $36.4 million a decrease of $1.6 million in OMIDRIA royalties or $5.4 million in net sales from the second quarter of 2024. And the Midway royalties decreased $700,000 or $2.3 million in net sales from the second quarter of 2023. As we discussed in prior earnings calls, in February 2024, we entered into an amended agreement with DRI by which they acquired the right to receive all U.S. OMIDRIA royalties payable by Rayner through December 31, 2031. We continue to hold all royalty rights to ex-U.S. sales of OMIDRIA and after December 31, 2031 all U.S. royalty rights returned to Omeros, resulting in all global royalty payments subsequently accruing to Omeros. Now let's look at our fourth quarter expected results. We expect overall operating costs from continuing operations in the fourth quarter to be similar to the third quarter. Interest income for the fourth quarter should be nearly $1.2 million and interest expense barring any adjustments related to the OMIDRIA royalty obligation should be approximately $7.2 million, which is a non-cash increase of $3.1 million from the third quarter reflecting the absence of any large non-cash adjustment related to the OMIDRIA royalty obligation. And as you may recall, the term loan transaction we completed in June of this year had an embedded gain of $29.8 million which was deferred and is being amortized as a reduction to interest expense. The amortization results in an effective interest rate of 1.5% or $400,000 on the term debt for financial statement purposes. And finally, income from discontinued operations should be in the $7 million to $8 million range. With that, I'll turn the conference over to Greg.
Gregory Demopulos: Thank you, David. Operator, now let's please open the call to questions.
Operator: Thank you. [Operator Instructions]. Our first question is going to come from the line of Steve Brozak with WBB. Your line is open. Please go ahead.
Steve Brozak: Yes. Hi and thank you for taking questions. I only have one. From what I've read and from what you've just stated, given the brevity of the requests from FDA of narsoplimab and given the fact that I'm sure you're going to turn to very quickly on the resubmission of the BLA, I would assume it's reasonable to say that you're going to be selling commercially on narsoplimab in 2025. Can you comment on that, please?
Gregory Demopulos: Well, I think that's certainly the hope and expectation, Steve. I think 2025, we'd actually be not looking into the latter part of it. We'd be looking for turning the BLA around quickly, again assuming alignment on really what's left to discuss on the SAP. And as I think we noted in the initial comments and as you just referenced, the request was really for additional sensitivity analyses only. So we would expect alignment, but we're waiting to receive comments on the SAP. Once we have those, we will quickly run the analyses or I should say our external consultants, the biostatistics group will run those, share those results with us, assuming those look good. And we would certainly expect that looking at the data that are available to us. We would then move quickly to resubmit the BLA. So yes, I think 2025 is certainly where we are targeting.
Steve Brozak: Got it. Okay. Thank you. Let me hop back in the queue.
Operator: Thank you. One moment for our next question. Our next question comes from the line from Olivia Brayer with Cantor. Your line is open. Please go ahead.
Olivia Brayer: Hi, good afternoon. Thank you for the question. For your MASP-3 inhibitor, Greg, what more can you tell us at this point about the Phase 3 trial designs for both indications? I know you made a few comments on PNH, but any additional color would be helpful or anything that you can tell us around FDA or EMA's feedback on those trials -- on that trial design specifically, I guess for PNH. Also wanted to ask about specific patient segments that you're planning to enroll or if there's anything that you can do to enrich the populations in those trials?
Gregory Demopulos: Yes. Let me answer generally and then I'll turn that over to our clinical team that's here as well to our representatives. But with respect to the Phase 3 trial design, they will be what we discussed in the opening comments. We're going to have one trial, which is a switch-over trial, where patients are treated with ravulizumab. Those patients not responding to ravulizumab or not optimally responding to ravulizumab, the C5 inhibitor, they go on combination therapy and then those that do respond to combination are rolled into monotherapy with zaltenibart alone. The second is again patients who have not been exposed or not being treated with complement inhibitors. The designs I think more specifically I'll let Andreas and Steve address, I'll just make one more comment on the FDA and the meetings with European regulators. Those meetings went very well. I think the response to our data and frankly to the drug in both of those settings was quite positive. And I think collaborative in that we're all working toward the same thing, which is moving zaltenibart through Phase 3 studies effectively and making it available to patients. That was certainly my takeaway from both of those meetings. With respect to population enrichment, again, let me turn this over first to Andreas and then Steve you as well.
Andreas Grauer: Yes. So just with regard to the design, the design of the switch-over trial is really following established precedent, very similar to the successful trial of Iptacopan. As Greg was pointing out, patients that are having an insufficient or unsatisfactory response to either IQ will then be available to be randomized to receive either zaltenibart or continue on their previous treatment. Second trial is a trial in a population of patients not currently treated with C5 inhibitor, either totally naive or with a long hiatus since there any kind of previous C5 inhibitor treatment so that they're functionally naive. And that trial, we're planning also a randomized trial where we're randomizing these patients to receive either zaltenibart or a C5 inhibitor. With regard to enrichment, the population that we're going to include in both trials are patients that do not -- that need treatment, i.e. that have a hemoglobin that is not satisfactory, specifically devoted to the transmitter and obviously are very confident that we're going to improve that.
Olivia Brayer: Okay, great. That's helpful. And then assuming that you guys do ultimately get awarded a priority review voucher for pediatric C3G. Can you just talk through what your strategy might be and whether selling the voucher is something that you're really considering?
Gregory Demopulos: It's a good question. I think at this point, Olivia, it's premature to discuss what our strategy would be. I think we would have to assess the landscape out there, what is the interest in the voucher, which historically is high. But I mean, we may well have reason and the good reason to keep it for ourselves as well. I mean, I think it all depends on how the studies play out, how our programs move forward and what the landscape looks like at that time.
Olivia Brayer: Okay, great. Very helpful. Thank you.
Gregory Demopulos: Thank you.
Operator: Thank you. And one moment for our next question. Our next question is going to come from the line of Serge Belanger with Needham. Your line is open. Please go ahead.
Serge Belanger: Hi, good afternoon. I guess a question on the OMS906 Phase 3 program. Can you just give us a sense of the potential size and cost estimate of this program and whether your current cash balance provides you with the bandwidth to move it forward or you would seek a partner to complete that Phase 3 program? Thanks.
Gregory Demopulos: Thank you, Serge. Again, I'll answer at a high level and then turn it to clinical to address the specific sizes of the studies. Certainly, we're looking to move the programs forward ahead independently. We are confident that we can do that. Data look really good and the safety profile of the drug, as I mentioned, really quite compelling. So we think we have significant differentiators between zaltenibart and other alternative pathway inhibitors on the market or in development. Now having said that, certainly we always have ongoing partnering discussions. We don't speak specifically to those. But as one might expect with a Phase 3 asset that looks like zaltenibart looks, there would be expected significant interest. So let me stop there and turn to, I don't know Andreas or Steve, who would like to address the size of these studies?
Andreas Grauer: The size of the study is we're planning and both of these studies will be effectively randomized and we're expecting the studies to be in the size of slightly below 100 patients per trial.
Gregory Demopulos: So these are relatively small studies and readily managed. Steve, anything you want to add to that?
Steven Whitaker: Well, I want to put just a little more color around it. We saw really good efficacy in the earlier studies that we did at PNH. So that really helps us with our power and so we don't have to get large at all. And I think another issue here as we look at the duration of the studies and we've already been finding pockets of patients. So we're we should be, we should hit the ground running in many places and be able to get this enrolled in a reasonably quick period of time.
Gregory Demopulos: That's great, Steve. Thank you. And thank you, Andreas. And just to underscore what you're saying then, the sort of the fixed monthly costs of running a drug trial we expect will be affected positively by the enrollment that we foresee for both of these studies and frankly the groundwork that the clinical operations team has done in identifying those patients, lining up those patients and our ability to enroll them and run them through the trial quickly. Is that a fair statement?
Steven Whitaker: Absolutely. They've done a great job.
Gregory Demopulos: Okay. All right. Thank you. Thanks, Serge.
Operator: Thank you. And I would now like to hand the conference back over to Dr. Demopulos for closing remarks.
Gregory Demopulos: Thank you, operator. So in closing, we'd like to thank all of you for joining the call. Obviously, we are encouraged by our recent meeting with FDA and expect that our to date lengthy engagement with the agency is nearing its conclusion, which should result in the resubmission of our BLA and that we have the additional evidence and analyses to support approval. We will of course keep you updated as we proceed. Again, all of us at Omeros appreciate your continued interest and your continued support. Have a good afternoon.
Operator: This concludes today's conference call. Thank you for participating. You may now disconnect.
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