Omeros Corporation

Good afternoon and welcome to today's earnings call for Ameros Corporation. At this time, all participants are in listen-only mode. After the company's remarks, we will conduct a question and answer session. Please be advised that this call is being recorded at the company's request. A replay will be available on the company's website for one week from today. I'll now turn the call over to Jennifer Williams, Investor Relations for Ameros.

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 factor section of the company's most recent annual report on Form 10-K for a discussion of these risks and uncertainties. Now, I would like to turn the call over to Dr. Greg Zimopoulos, Chairman and CEO of Omero.

Thank you, Jennifer, and good afternoon, everyone. I'm joined on today's call by Mike Jacobson, Nadia Dock, Andreas Grauer, Kathy Melfi, and Steve Whitaker. collectively representing our finance, commercial, clinical, and regulatory functions. I'll start today with an overview and discussion of our first quarter 2024 financial results, followed by an update on our ongoing development programs. Mike will then provide a more detailed financial summary before we open the call to questions. Let's now look at our financial results for the first quarter. Our net loss for the first quarter of 2024 was $37.2 million or 63 cents per share compared to a net loss of $9.1 million or 15 cents per share in the fourth quarter of last year. The difference is driven by two factors. In the fourth quarter of last year, we had a re-measurement adjustment of $26.2 million to our Omidria contract royalty asset as a result of our Omidria royalty sale to DRI Healthcare. And a $4.1 million gain on early retirement of a portion of our 2026 convertible notes following the fourth quarter open market repurchase of a notional amount of $9.1 million of those notes at a cost of $4.9 million, or 54% of par value. Excluding these two transactions, our fourth quarter 2023 net loss would have been similar to that of the current quarter. As of March 31, 2024, we had $230.3 million of cash and investments on hand available to support ongoing operations and debt service, an amount that we expect will be sufficient to fund operations and debt service into 2026. In addition, one of our two negotiated milestone payments of up to $27.5 million based on sales milestones of OMIDRIA, if met, becomes payable to OMEROS in January 2026, with the second $27.5 million milestone similarly payable in January 2028. Let's now review our development programs. We provided a comprehensive update on these programs during our earnings call just last month, so today's update will be somewhat brief. We'll start with narsoplimab, our MASK2 inhibitor targeting the lectin pathway of complement. As described last month, discussions are ongoing with FDA regarding the resubmission of our biologic license application, or BLA, or narsoplumab in hematopoietic stem cell transplant-associated thrombotic microangiopathy, or TATMA. Given the prescribed timelines and rules regarding meetings with FDA, we do not at this time have a firm date for BLA resubmission or the related decision date for approval. As I noted last month, when we do have that information, we'll provide you with an update. We remain optimistic in the approval of Narsoplimab. In the meantime, we continue supplying Narsoplimab under our expanded access program to TATMA patients and their physicians, although Given the program's financial burden on OMEROS, we are assessing how much longer we'll be able to maintain that program. Support for narsoplumab within the transplant community is strong and continues to grow. In addition to the recent publications discussed in our last earnings call, a manuscript directed to the outcome of narsoplumab treatment in 20 real-world adult and pediatric patients 19 of whom had high-risk characteristics, is expected to be published soon in Nature's Bone Marrow Transplantation. Let's now turn to OMS906, our MASC-3 inhibitor targeting the alternative pathway of complement. OMS906 is advancing well through multiple ongoing Phase II studies in two rare disease indications. paroxysmal nocturnal hemoglobinuria, or PNH, a life-threatening hematologic disorder, and complement 3 glomerulopathy, or C3G, a debilitating and potentially life-threatening kidney disease. Across all of our clinical studies to date, OMS 906 continues to perform extremely well. On last month's call, I went through a detailed review of the substantial value being built in our OMS 906 program, value which we believe remains largely under recognized by the investment community. To summarize, we believe that OMS 906 has several distinct and substantial benefits which make us confident that OMS 906 will favorably differentiate compared to other alternative pathway inhibitors currently available or in development. Adding to our confidence demonstrated efficacy with other alternative pathway inhibitors such as the factor B inhibitor of tacopan further de-risk our OMS 906 programs by clinically validating alternative pathway inhibition across a list of disease indications including PNH, IgA nephropathy, and most recently, C3G. While we are targeting Iptacopan as our benchmark to be, and we expect that we should, Iptacopan continues to build a roadmap for us to follow with phase three trials designed to highlight the potential advantages of OMS-906 over other alternative pathway inhibitors. We've detailed on previous calls what we see as the major differentiators between MAS-3 and OMS-906 versus other alternative pathway targets and therapeutics either approved or in development. These include that, one, Masp3 inhibition, unlike C3 and C5 inhibitors, leave entirely intact the infection-fighting lytic arm of the classical pathway of complement, an advantage that could well translate to better safety. Two, unlike C3, C5, and Factor B, Masp3, when examined, has been shown not to be an acute phase reactant, which is thought to be an important advantage in maintaining adequate and consistent dosing to prevent breakthrough of the underlying disease. And three, with once every two months to once quarterly dosing, OMS 906 is expected to provide superior patient convenience and compliance. Market research to date has demonstrated a consistently favorable response to OMS-906 among physicians, driven by the drug's database expected efficacy and low treatment burden. Interestingly, physicians have also shown a preference for both the once every two months and the once quarterly intravenous dosing of OMS-906 over the twice daily oral dosing. This is because the dosing regimens of OMS-906 coincide with the usual physician follow-up schedule for PNH patients and would allow physicians to oversee drug administration, ensuring patient compliance. From the patient's perspective, the extended interval dosing regimens of OMS-906 should allow them to live a more normal life without the daily oral medication reminder that they are sick. Our three trials in our OMS 906 Phase II clinical program in PNH are progressing well. The first evaluating OMS 906 in PNH patients who have not previously been treated with a complement inhibitor, in other words, complement inhibitor naive, has fully enrolled and is in the dose finding stage, assessing administration every eight or every 12 weeks. The second trial has a switchover design, enrolling PNH patients who have a suboptimal response to the C5 inhibitor rabulizumab. OMS906 is initially administered to these patients in combination with Ravulizumab for 24 weeks. And then, in those patients who demonstrate a hemoglobin response with the combination therapy, OMS906 is delivered as monotherapy. The switchover study is also fully enrolled, and we're currently collecting OMS906 monotherapy data. A third phase two PNH trial, an extension trial, is enrolling patients who have completed either of the other two OMS906 PNH studies and is generating long-term efficacy and safety data for our program. Results from the combination stage of the phase two switchover trial have been selected for podium presentation at the annual Congress of the European Hematology Association next month. Dr. Morag Griffin, an internationally recognized expert in PNH from the St. James Teaching Hospital in Leeds, England, will deliver the presentation. The presentation reports the results in PNH patients with two different doses of OMS-906. All patients in the high dose group achieved clinical response which is defined as an increase in hemoglobin of at least two grams. And six of seven patients in the low dose group also achieved the same level of clinical response. No patients in either dose group required transfusions following initiation of OMS 906. The drug was well tolerated without any safety signal of concern. There will also be two poster presentations at EHA directed to the pharmacokinetics and mechanism of action of OMS 906. Given the rapid progress and impressive performance of OMS 906 in PNH, we remain on track to initiate our OMS 906 phase three PNH program in the fourth quarter of this year. Our phase two clinical trial Evaluating OMS 906 in C3G is enrolling. Here again, we remain on track and expect to begin a Phase III program in C3G in the first quarter of 2025. In preparation for both the P&H and C3G OMS 906 Phase III programs, discussions are ongoing with both U.S. and European regulators. So, in conclusion, around OMS-906, based on data to date, we believe that OMS-906 has a high likelihood of success, both with respect to patients' lives and to market impact. Let's now discuss OMS-1029, our long-acting inhibitor of MASK2 targeting the lectin pathway. OMS 1029 successfully completed a phase one single ascending dose study supporting once quarterly dosing administered either subcutaneously or intravenously. The second half of that phase one program, a multiple ascending dose study of OMS 1029 is expected to read out data to our team later this quarter. As previously disclosed, we are evaluating several chronic large value indicators and indications for potential development of OMS1029. Among these is neovascular age-related macular degeneration, also known as wet AMD. MASK2 inhibition was previously demonstrated to be effective in a preclinical murine model of wet AMD. To further qualify the opportunity, we've initiated evaluation of OMS 1029 in a primate model of wet AMD. Notably, all approved treatments for wet AMD, such as Lucentis and ILEA, require intravitreal injections, meaning injections into the posterior chamber of the eye. These injections are required as frequently as every four weeks, and obviously are not ideal for patient comfort. Since MASP2 is produced exclusively in the liver, systemic administration alone could block MASP2, providing therapeutic benefit without the need for intravitreal injection. Simply put, intravenous or subcutaneous administration of OMS 1029 could allow patients to maintain their sight and avoid painful injections in their eyes, a potential game changer in a very large market for both patients and their physicians. We continue to target next quarter to select a phase two indication for OMS 1029. With less resource intensive, Work our ongoing efforts with narsoplamab in both severe acute and long COVID or PASC, as well as in acute respiratory distress or ARDS, including H1N1 and H5N1, could add meaningful shareholder value in the near term. The international literature, some of that novel work continuing to be generated by our team, increasingly support the central role of the lectin pathway in these diseases. As part of our efforts, we've developed an assay that can differentiate based on lectin pathway activation between those patients with mild COVID and those with severe ARDS-related COVID requiring hospitalization. The assay also has potential applicability to patients with other forms of ARDS and to patients with long COVID as well. In addition to our MASK2 and MASK3 antibody inhibitors and our soplumab OMS906 and OMS1029, our complement franchise includes our developing small molecule orally available MASK2 and MASK3 inhibitor programs, both of which are advancing rapidly. Our oral MASK2 inhibitor is further ahead, and we are considering well-suited indications for clinical trials. Our oral MASK3 inhibitor program is quickly driving toward a drug development candidate, leveraging in good part all that we learned throughout our MASK2 small molecule program. Turning to OMS 527, our PD7 inhibitor program aimed at treating addictions, compulsions, and movement disorders. At the directed request of the National Institute on Drug Abuse, or NIDA, we are developing OMS 527 as a potential treatment for cocaine use disorder. The program is funded by NIDA through a $6.7 million grant. We anticipate receiving results later this year from a preclinical toxicology study of primates exposed to both cocaine and OMS 527. Assuming positive results in the toxicology study, we plan to initiate next year a randomized double-blind inpatient clinical trial evaluating OMS 527 in individuals with cocaine use disorder. Also, as referenced in last month's call, we're exploring the potential use of OMS 527 in movement disorders, specifically levodopa-induced dyskinesias or LID. This is a major problem in patients treated with levodopa, and levodopa being the most common therapeutic used in Parkinson's disease. As such, LID represents a large and effectively untapped commercial market. Our set of cellular and biologic immuno-oncology platforms also have the potential to generate near-term shareholder value. Following the recent generation of a large volume of exciting in vivo data, our primary focus is on signaling-driven immunomodulators antigen-driven immunomodulators that function both as therapeutics and vaccines, oncotoxins, and adoptive T cell therapy, which we believe could supersede CAR T. These platforms represent novel approaches to cancer treatment designed to target both cell surface and intracellular cancer targets for broad cancer applicability. to increase both CD4 and CD8 levels to mitigate loss of treatment effect seen with other therapies like checkpoint inhibitors, to eliminate the need for costly and time-intensive cellular modification or engineering, and to create immune memory against future relapse. We continue building out a broad intellectual property position and expect to share more of our data later this year. I'll now turn the call over to Mike Jacobson, our Chief Accounting Officer, to go through a more detailed discussion of our financial results. Mike?

Thanks, Greg. Our net loss from the first quarter of 2024 was $37.2 million, or 63 cents per share. compared to a net loss of $9.1 million, or 15 cents per share, in last year's fourth quarter. As Greg mentioned, in the fourth quarter of last year, we had a remeasurement adjustment of $26.2 million to our mid-year contract royalty asset due to the mid-year royalty sale to DRI Healthcare, and also a $4.1 million being on the early extinguishment of a portion of our 2026 notes. Looking only at continuing operations, our net loss in the current quarter was $43.9 million or $0.75 per share, compared with $39.3 million or $0.63 per share in the prior year quarter. The prior year fourth quarter benefited from the $4.1 million gain on the early extinguishment of the portion of the 26 notes. Without this extinguishment transaction, our loss from continuing operations for Q4 and Q1 would have been within $450,000 of each other. As of March 31st, we had $230 million of cash and investments on hand, an increase of $58 million from year end. The two first quarter transactions significantly affected our Q1 ending cash balance, both on a, you know, On a positive basis for the DRI deal, which brought in $115 million of non-diluted capital, with the opportunity to earn up to an additional total of $55 million and two more sales-related milestone payments of $27.5 million each. And then, secondly, the repurchase of the 3.2 million shares of our common stock for an aggregate purchase price of $11.9 million. decreased our cash balance combined with our common stock purchases in the fourth quarter of 23 our total common stock repurchases to date are five million shares or eight percent of our outstanding common stock for an aggregate purchase price of sixteen point five million dollars or three dollars and thirty cents per share cost expenses from continuing operations for the first quarter was thirty nine million dollars which was a decrease of $700,000 from the fourth quarter of last year. The decrease was driven by lower expenditures on the IGAN clinical trial as we pulled down the trial, and by lower manufacturing costs. These decreases were partially offset by higher compensation costs recorded in the first quarter. Interest expense for the first quarter was $8.2 million. which is $1.2 million higher than the fourth quarter of last year due to increased interest associated with the DRI transaction that was finalized in February of 2024. The primary drivers of interest expense, again, are the 2026 notes and the DRI Omidriac royalty obligation. Interest and other income for the first quarter was $3.4 million, which was comparable to the fourth quarter of last year. Income from discontinued operations for this quarter was $6.7 million, and includes two primary components. $4.3 million of interest earned on the immediate contract royalty assets, and then $2.3 million of remeasurement adjustments related to the immediate contract royalty assets. As I've mentioned previously, royalties earned are recorded as a reduction in the Emitria contract royalty asset on our balance sheet. Emitria royalties for the first quarter were $9.4 million, and Emitria net sales of $31.2 million. This is compared to net sales in the fourth quarter of $35.7 million, or a $4.5 million decrease in the current quarter compared to the previous fourth quarter with a $500,000 increase over the prior year first quarter. The decrease in net sales is expected given that Q1 historically represents the lowest quarter annually for amidria net sales, while Q4 is generally one of the smallest. As Greg mentioned, in February this year we entered into an amended agreement with the DRI by which they acquired the right to receive all U.S. amidria royalties payable by rain through December 31st of 2031. We continue to hold all royalty rights to ex-U.S. sales of the mid-range, and after December 31st, 2031, all U.S. royalty payments will also accrue to AmeriCorps. The U.S. royalty rate is generally 30% of net sales, and it stands for the duration of the relevant patent terms, which we expect to be at least into 2035. As I mentioned, we are also entitled, now and going forward, to any non-U.S. royalties which are paid, which are generally 15% of net sales. In the first quarter of 2024, we recorded the $115.5 million we received from DRI as incremental amid the royalty obligation on our balance sheet. This is consistent with accounting of the initial transaction with DRI. Now, let's take a look at our expected second quarter results. We expect overall operating costs from continual operations in the first quarter, our operations in the second quarter to increase by about $16 to $17 million in the first quarter. The increase is primarily due to the expected receipt of drug substance manufactured from our third-party vendor, which is expensed upon delivery to us. As you may recall, we expense all manufacturing costs until we are reasonably assured of approval in the U.S. or the European Union. Interest income for the second quarter should be nearly $3 million, and interest expense should be approximately $9 million, which is an increase of $800,000 over the first quarter. The increase in interest expense is due to incremental interest recorded as a result of completing the DRI transaction Income from discontinued operations should be in the $7 to $8 million range. With that, I'll turn the call back over to Greg. Greg?

Okay. Thanks, Mike. Operator, let's please open the call to questions.

Certainly. Ladies and gentlemen, if you do have a question at this time, please press star 1-1 on your telephone. If your question has been answered and you'd like to remove yourself from the queue, simply press star 1-1 again. Our first question comes from the line of Steve Brozek from WBB Securities. Your question, please.

Hi, Greg. Thank you for taking the call. Just one question. On 906, you were pretty extensive in how you described the therapeutic window and how it would work, but tell me something. What are the KOLs giving you in terms of information on what they see and how important this will be? And then I've got one follow-up after that. Thank you.

Okay, well, let me first take that, and then I think I'll hand it off to clinical and commercial as well. But I think, as we said in the prepared comments, that the response with the market research done today, which has included physicians and within that physician group, key opinion leaders, has been consistently positive. And as I mentioned, that's really been driven by two primary factors. One is the data to date. And based on the data to date, the expected efficacy, the anticipated efficacy of OMS 906 in patients. And the second is its dosing ability, meaning every other month to once quarterly dosing. That represents a significant reduction in patient burden. It coincides with how physicians follow their patients so that physicians can then administer the drug. And the importance of that is physicians then are comfortable, they're confident, they know that the patients are in fact complying with treatment. They know it because they're administering the treatment. So those are all seen as I think very positive attributes. I think that certainly also when you think about how patients would view this, taking some sort of infusion, whether it's sub-Q, whether it's IV, once every other month, once quarterly, they're not consistently and repeatedly reminded that they're sick. Instead, they go and have the infusion, they walk away, they live their lives as they otherwise would live. And taking an oral medication once daily, certainly twice daily, is a constant reminder, I think, to patients that, you know, gee, there's a problem here with which I have to deal for my whole life. We think the response also from physicians has been that's a positive. But let me stop there. And I think first let me ask clinical and then follow up with commercial. Andreas, do you have anything to add? Or Steve, anything to add to that?

I think the consideration, you mentioned the twice oral treatment. That is obviously great. It's convenient for many. think you have gastrointestinal upset, you have diarrhea, you travel different time zones, there are complications that make this supposedly simple regimen not quite as simple. So taking something every other month or every quarter and not having to worry about it in the meantime is attractive for a significant number of patients and physicians because they will know that they have given it.

Do you have anything to add from clinical on that? I think everything's been well said. I haven't encountered anything but enthusiasm when talking to KOLs and talking to physicians who treat these patients. Potential clinical sites are seeing no problems with this regimen and think it'll be attractive to trial participants.

And what I'll add is that we are in the middle of extensive market research and it's so exciting to hear the reactions to the product profile for 906. Bottom line, the doctors are telling us patients need options and they're very encouraged by what they're seeing, both efficacy but delivered with a low treatment burden, essentially moving to only four times a year. So we're also excited about the opportunity to meet with patients in a market research capacity later this month and continue this work.

Well, thank you. Thank you. So, Steve, I think you said you had a follow-up, but I don't know. We may have answered that already for you, but let us know.

You actually did ask and answer, but I appreciate the detail and the depth that you went into. Let me hop back into the queue. Thanks very much.

Okay, thank you. Thank you. One moment for our next question. And our next question comes from the line of Olivia Breyer from Cantor Fitzgerald. Your question, please.

Hey, good afternoon, guys. Thank you for the question. For the OMS 906 update coming, wanted to clarify that the data we'll see at EHISE is just through week 24, and that final switchover portion of the trial is later in the year. Is that right? And then maybe just help frame what level of efficacy you're looking to see later in the year from that monotherapy portion specifically.

Sure. First, in answer to your initial question, yes, it's through the first 24 weeks, so it's through the combination therapy portion of the clinical trial. We are still collecting monotherapy data, and we expect to have those data later in the year. With respect to what specifically we're targeting on the monotherapy side, I think that, and again, I'll turn this to clinical, but I can tell you my target there is that certainly what we're seeing is a meaningful improvement in hemoglobin in these patients on monotherapy over what they were receiving on raviolizumab. But let me look to clinical and see if they have other things to add to that.

I think that we are looking for data that are at least comparable to those of other switch studies that have been reported. The EHE abstract, I'm sure you know, is now available online. I think it came out yesterday or the day before when it was made public. And in that abstract, we note that in our high-dose group in that study, we looked at two different dose groups, dose escalation study. But in the high-dose group, all of the patients treated at the high dose achieved clinical response of, you know, that's 100%. That's a 2 gram per deciliter increase in hemoglobin. which was one of the primary or co-primary endpoints of the Atacapan trials, and that certainly compares favorably to other switch studies.

Even in the low dose, I think six of seven achieved that, right? So, no, we're quite happy with how the data are looking, with how 906 is looking generally. We think the data are impressive. They continue to be impressive. And we're just looking forward to initiating phase three and, frankly, completing our phase three program and bringing OMS 906 to market.

Thank you both. Looking forward to those updates.

All right. Thank you, Olivia. Thank you. One moment for our next question. And our next question comes from the line of John Gianco from Needham and Company.

Your question, please.

Hi, everyone. Thanks for taking my questions. I'm on for surge today. First, regarding the OMS 906 trials, can you provide any color on what we can expect after the data is released, and particularly whether we can expect meetings with the FDA ahead of the Phase III initiation? And then second, regarding the Narsoplimab DLA resubmission, obviously you mentioned updates are soon to come. Can you give any context to progress made with the FDA since we last received an update in April, or kind of if the ball is in their hands at this time? Thanks.

Yes, in answer to your first question, Discussions, interactions are ongoing with both U.S. and European regulators as we prepare for the phase three trial or phase three program. So let me just turn to Kathy and see, Kathy, can you add more color to that?

Yeah, I mean, it really is fairly standard, and we are making sure that we are keeping the communication lines open in both the U.S. and Europe and trying to harmonize those as much as we can so that we have a very efficient phase three program.

Okay, thank you. And in answer to your second question, we really are not and have not, do not provide sort of running commentary on our interactions with regulators. So there's not much that I have to say there other than we clearly are comfortable, confident, In the data that we have, we believe the drug certainly warrants approval and that is our objective. When you look at the utilization of the drug across the compassionate use or what is more formally called the expanded access program, the data are really very clear. And we're eager to get the drug approved. There is no drug approved for this indication. We think it compares very favorably to other agents that are currently being used off-label in this indication. And we're hearing similar things quite widely from physicians both in the U.S. and internationally. So it's been a long time, we recognize that, but our expectation, certainly our strong hope and expectation is that we will get this approved. It certainly warrants it.

Thank you.

This does conclude the question and answer session of today's program. I'd like to hand the program back to Dr. Dimopoulos for any further remarks.

Thank you, operator, and again, thank you all for joining this afternoon. We're pleased with our first quarter progress across our programs and believe that we are well positioned for continued success throughout the remainder of 2024 and beyond. So we look forward to bringing you future updates, and as always, we appreciate your continued support. Have a good afternoon.

Thank you, ladies and gentlemen, for your participation at today's conference. This does conclude the program. You may now disconnect. Good day.