Q1 2024 Omeros Corporation Earnings Call
[music].
Okay.
Yeah.
Operator: Good afternoon, and welcome to today's earnings call for Omeros Corporation. At this time, all participants are in listen-only mode.
Operator: 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, and 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 Omeros.
Speaker Change: Good afternoon, and welcome to todays earnings call for it Melrose Corporation.
Speaker Change: This time all participants are in a 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 and a replay will be available on the company's website for one week from today.
Speaker Change: I'll now turn the call over to Jennifer Williams Investor Relations for our metros.
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 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 Demopulos, Chairman and CEO of Omeros.
Jennifer Cook Williams: Good afternoon, and thank you for joining the call today.
Speaker Change: I can remind you that some of it.
Speaker Change: And 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 time 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.
Speaker Change: 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.
Speaker Change: Now I would like to turn the call over to Dr. Greg Glenn Demopoulos, Chairman and CEO of America. Thank you.
Gregory A. Demopulos: Thank you, Jennifer, and good afternoon, everyone. I'm joined on today's call by Mike Jacobsen, Nadia Dac, Andreas Grauer, Cathy 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 program. 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.
Speaker Change: You Jennifer and good afternoon, everyone I'm joined on today's call by Mike Jacobsen Nordea Dock, Andreas Grauer, Cathy Melfi as Dave would occur.
Speaker Change: I believe representing our finance commercial clinical and regulatory functions.
Gregory A. Demopulos: 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 $0.15 per share, in the fourth quarter of last year. The difference is driven by two factors.
Speaker Change: 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.
Speaker Change: Mike will then provide a more detailed financial summary, before we open the call to questions.
Gregory A. Demopulos: In the fourth quarter of last year, we had a remeasurement 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 Excluding these two transactions, our fourth-quarter 2023 net loss would have been similar to that of the current quarter.
Speaker Change: Let's now look at our financial results for the first quarter.
Speaker Change: Our net loss for the first quarter of 2024 was $37.2 million or 63 cents per share.
Speaker Change: Compared to a net loss of $9 $1 million or 15 cents per share.
Speaker Change: The fourth quarter of last year.
The difference is driven by two factors in the fourth quarter of last year, we had a remeasurement adjustment of $26 $2 million to our omidria contract royalty assets as a result of our omidria royalty sale to DRA in health care.
Speaker Change: And a $4 $1 million gain on early retirement of a portion of our 2026 convertible notes.
Speaker Change: Following the fourth quarter open market repurchase.
Speaker Change: Notional amount of $9 $1 million of those notes.
Speaker Change: Cost of $4 $9 million or 54% of par value.
Speaker Change: Excluding these two transactions our fourth quarter 2023, net loss would have been similar to that of the current quarter.
Gregory A. Demopulos: 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 for Omidria, if met, becomes payable to Omeros in January 2026, with the second $27.5 million milestone payable in January 2028.
Speaker Change: As of March 31, 'twenty 'twenty, four we had $233 million of cash and investments on hand.
Speaker Change: <unk> to support ongoing operations and debt service.
Speaker Change: An amount that we expect will be sufficient to fund operations and debt service into 2026.
Speaker Change: In addition, one of our two negotiated milestone payments of up to 27 $5 million based on sales milestones of Omidria, if Matt <unk>.
Speaker Change: Tom's payable to <unk> in January 2026, with the second 27 $25 million milestone Similarly payable in January 2028.
Gregory A. Demopulos: 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 MASP2 inhibitor targeting the lectin pathway of complement. As described last month, discussions are ongoing with FDA regarding the resubmission of our Biologics License Application, or BLA, for Narsopilumab 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 the BLA resubmission or the related decision date for As I noted last month, when we do have that information, we'll provide you with an update.
Speaker Change: Let's now review our development programs are we provided a comprehensive update on these programs during our earnings call just last month.
So today's update will be somewhat brief.
Speaker Change: We will start with and are supplemented by our mast two inhibitor targeting the lectin pathway of complement.
Speaker Change: As described last month discussions are ongoing with FDA regarding the resubmission of our biologics license application or BLA.
Or in our stock blow map and hematopoietic stem cell transplant associated thrombotic microangiopathy or Ta TMA.
Speaker Change: Given the prescribed timelines and rules regarding meetings with FDA, we do not at this time I have a firm date for BLA resubmission or the related decision date for approval.
Speaker Change: As I noted last month, when we do have that information will provide you with an update.
Gregory A. Demopulos: We remain optimistic about the approval of Narsoplimen. In the meantime, we continue supplying narsoplamib under our expanded access program to TATMA patients and their physicians. However, given the program's financial burden on Omeros, we are assessing how much longer we'll be able to maintain that program.
Speaker Change: We remain optimistic in the approval of our supplement.
Speaker Change: In the meantime, we continue supplying nurse thoughtful amount under our expanded access program to Ta TMA patients and their physicians, although given the programs financial burden on them arrows, we are assessing how much longer will be able to maintain that program.
Gregory A. Demopulos: Support for Narsopilumab 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 narsopilumab 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 MAS3 inhibitor targeting the alternative pathway of complement. OMS 906 is advancing well in multiple ongoing phase two 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.
Support for <unk> within the transplant community is strong and continues to grow.
Speaker Change: In addition to the recent publications discussed in our last earnings call.
Speaker Change: A manuscript directed to the outcome in our supplemental treatment and 20 real world adult and pediatric patients 19 of who had high risk characteristics characteristics.
Speaker Change: As expected to be published soon and natures bone marrow transplantation.
Speaker Change: Let's now turn to almost 906 are masked III inhibitor targeting the alternative pathway of complement.
Speaker Change: Well almost 900 <unk> is advancing well with multiple ongoing phase III studies in two rare disease indications.
Speaker Change: Paroxysmal nocturnal hemoglobinuria or <unk>, a life threatening hematologic disorder.
Speaker Change: And complement three gillum, Mary Allopathy or C. Three G.
Speaker Change: Debilitating and potentially life threatening kidney disease.
Gregory A. Demopulos: 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.
Speaker Change: Across all of our clinical studies to date.
Speaker Change: 906 continues to perform extremely well.
Speaker Change: On last month's call I went through a detailed review of the substantial value being built in our almost 906 program.
Speaker Change: <unk>, which we believe.
Speaker Change: Largely under recognized by the investment community.
Gregory A. Demopulos: To summarize, we believe that OMS906 has several distinct and substantial benefits that make us confident that OMS906 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 tacropan, further de-risks our OMS906 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 Atakapan as our benchmark to beat, and we expect that we should
Speaker Change: To summarize we believe that RMS lineup fix has several distinct and substantial benefits, which make us confident that <unk> 906 will favorably differentiate compared to other alternative pathway inhibitors currently available.
Speaker Change: Or in development.
Speaker Change: Adding to our confidence demonstrated efficacy with other alternative pathway inhibitors, such as the factor B inhibitor Tak, Japan further de risk our LMS 906 programs by clinically validating alternative pathway inhibition across a list of diseases.
Indications, including <unk> Iga nephropathy.
Speaker Change: Most recently <unk>.
Speaker Change: While we are targeting attack, Japan, as our benchmark to be.
Speaker Change: And we expect that we should.
Gregory A. Demopulos: If tachypan continues to build a roadmap for us to follow with phase 3 trials designed to highlight the potential advantages of OMS906 over other alternative pathway inhibitors. We've detailed on previous calls what we see as the major differentiators between Mast 3 and OMS 906 versus other alternative pathway targets and therapeutics, either approved or undeveloped. These include that one, MAP3 inhibition, unlike C3 and C5 inhibitors, leaves entirely intact the infection-fighting lytic arm of the classical pathway of complement, an advantage that could well translate to better safety.
Speaker Change: <unk> continues to build a roadmap for us to follow with phase III trial designed to highlight the potential advantages of RMS 906 over other alternative pathway inhibitors.
Speaker Change: We have detailed on previous calls what we see as the major differentiators between mastery in RMS 906 versus other alternative pathway targets and therapeutics either approved or in development.
These include that one mascara inhibition. Unlike C. Three industry five inhibitors leave entirely intact. The infection fighting lytic arm of the classical pathway of complement <unk>.
Speaker Change: An advantage that could well translate to better safety.
Gregory A. Demopulos: Unlike C3, C5, and Factor B, MASK-3, 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 month and the once-quarterly intravenous dosing of OMS-906 over the twice-daily oral dosing of iptacapin.
Speaker Change: Two.
Speaker Change: Unlike sheath three C five and factor B masks when examined has been shown not to be an acute phase reactive which is thought to be an important advantage in maintaining adequate and consistent dosing to prevent breakthrough of the.
Speaker Change: <unk> disease and.
Speaker Change: And three with once every two months there once quarterly dosing.
Speaker Change: 906 is expected to provide superior patient convenience and compliance.
Speaker Change: Market research to date has demonstrated a consistently favorable response to almost 906 among physicians drew.
Speaker Change: Driven by the drugs databased expected efficacy and low treatment burden.
Speaker Change: Interestingly physicians have also shown a preference for both the once every two months.
Speaker Change: And the ones quarterly intravenous dosing of almost 906 over the twice daily oral dosing of <unk>.
Gregory A. Demopulos: 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 OMS906 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, first evaluating OMS906 and PNH patients who have not previously been treated with a complement inhibitor, in other words, complement inhibitor naive. These trials have fully enrolled and are 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.
Speaker Change: This just because of the dosing regimens of <unk> 906 coincide with the usual physician follow up schedule for patients and would allow physicians to oversee drug administration, ensuring patient compliance from the patients perspective the <unk>.
Speaker Change: <unk> interval dosing regimens of <unk> 906 should allow them to live a more normal life without the daily oral medication reminder.
Speaker Change: They are sick.
Speaker Change: Our three trials in our RMS 906 phase II clinical program in <unk> are progressing well.
Speaker Change: First evaluating <unk> 960, <unk> patients who have not previously been treated with a complement inhibitor in other words, a complement inhibitor naive.
Speaker Change: Has fully enrolled and is in the dose finding stage assessing administration every eight or every 12 weeks.
Speaker Change: The second trial has a switchover design enrolling <unk> patients who have a suboptimal response to the C. Five inhibitor Ravi Iliza map.
Gregory A. Demopulos: OMS 906 is initially administered to these patients in combination with Ravulizumab for 24 weeks. Then, in those patients who demonstrate a hemoglobin response to the combination therapy, OMS 906 is delivered as monotherapy. The switchover study is also fully enrolled, and we're currently collecting OMS906 monotherapy data. A third Phase II 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.
Speaker Change: 906 is initially administered to these patients in combination with Ravi Alyssa Mab for 24 weeks and then in those patients who demonstrated hemoglobin response with the combination therapy <unk> 906 is delivered as mono therapy.
Speaker Change: The switchover study is also fully enrolled and we are currently collecting Oems 906 monotherapy data.
Speaker Change: A third phase II <unk> trial, an extension trial is enrolling patients who have completed either of the other two Oems 906, <unk> studies and is generating long term efficacy and safety data for our program.
Gregory A. Demopulos: Results from the combination stage of the Phase II switchover trial have been selected for a 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. This presentation reports the results in PNH patients with two different doses of OMS-906. All patients in the high-dose group achieved a clinical response, which is defined as an increase in hemoglobin of at least 2 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 signals of concern.
Speaker Change: Results from the combination stage of the phase II switchover trial have been selected for podium presentation at the annual Congress of the European Hematology Association next month.
Speaker Change: Doctor Moraga Griffin, an internationally recognized expert in <unk> from the St. James teaching hospital.
Speaker Change: Leaves, England will deliver a presentation.
Speaker Change: The presentation reports the results in <unk> patients with two different doses of <unk> 906.
Speaker Change: All patients in the high dose group achieved clinical response.
Speaker Change: <unk> is defined as an increase in hemoglobin of at least two grams.
Speaker Change: Six of seven patients in the low dose group also achieved the same level of clinical response.
Speaker Change: No patients in either dose group required transfusions.
Speaker Change: Initiation of RMS 906.
Speaker Change: The drug was well tolerated without any safety signal of concern.
Gregory A. Demopulos: 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 III 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 three program in C3G in the first quarter of 2025.
Speaker Change: There will also be two poster presentations at IHA directed to the pharmacokinetics and mechanism of action of <unk> 96.
Speaker Change: Given the rapid progress and impressive performance of almost 906 <unk>, we remain on track to initiate our RMS 906 phase III <unk> program in the fourth quarter of this year.
Speaker Change: Our phase II clinical trial evaluating <unk> 906, <unk> three G is enrolling here again, we remain on track and expect to begin a phase III program in <unk>.
Speaker Change: In the first quarter of 2025.
Gregory A. Demopulos: In preparation for both the PNH and C3G-OMS906 Phase III programs, discussions are ongoing with both U.S. and European regulators. So, in conclusion... Regarding 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 MASK-2 targeting the lectin pathway. OMS-1029 successfully completed a phase one single ascending dose study supporting once quarterly dosing administered either subcutaneously or intravenously.
Speaker Change: In preparation for both the Pn H C. <unk> <unk> 906 phase III programs.
Speaker Change: Discussions are ongoing with both U S and European regulators.
Speaker Change: So in conclusion.
Speaker Change: Around 906 based on data to date, we believe that <unk> 906 is a high likelihood of success.
Speaker Change: Both with respect to patients lives.
Speaker Change: And to market impact.
Gregory A. Demopulos: 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 OMS 1029. Among these is neovascular age-related macular degeneration, also known as wet AMD.
Speaker Change: Let's now discuss Armours $10 29, our long acting inhibitor of matched to targeting the lectin pathway.
Speaker Change: 10, 29 successfully completed a phase one single ascending dose studies supporting once quarterly dosing administered either subcutaneously or intravenously.
Speaker Change: Half of that Phase one program a multiple ascending dose study of <unk> 10, 29 is expected to read out data to our team.
Speaker Change: Later this quarter.
Speaker Change: As previously disclosed we are evaluating several chronic large value indicators and into care indications for potential development.
Speaker Change: At $10 29.
Speaker Change: Among Greece is neovascular age related macular degeneration also known as wet AMD.
Gregory A. Demopulos: MAP2 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.
Speaker Change: <unk> two inhibition was previously demonstrated to be effective in a preclinical murine model of wet AMD.
Speaker Change: To further qualify the opportunity we've initiated a valuation of Oems $10 29 in a primate model of wet AMD.
Speaker Change: Notably all approved treatments for wet AMD, such as Lucentis and Eylea require intra vitriol injections, meaning injections into the post cheerier chamber of the eye.
Speaker Change: These injections are required as frequently as every four weeks and obviously are not ideal for patient comfort.
Mafia III has produced exclusively in the liver <unk>.
Gregory A. Demopulos: 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 sites 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 2 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.
Speaker Change: Systemic administration alone could block mask to providing therapeutic benefit without the need for <unk> injection simply put.
Speaker Change: Intravenous or subcutaneous administration of <unk>.
Speaker Change: $10 29 could allow patients to maintain their site.
Speaker Change: And avoid painful injections and there is a potential game changer, and a very large market for both patients and their positions.
Speaker Change: We continue to target next quarter to select a phase II indication for LMS $10 29.
Speaker Change: With less resource intensive.
Speaker Change: Yeah.
Speaker Change: Work are ongoing efforts with <unk> and both severe acute online covered or past as well as an acute respiratory distress or <unk>, including H. One N. One an H five N one could add meaningful shareholder value in the near term.
Gregory A. Demopulos: The international literature, some of that novel work continuing to be generated by our team, increasingly supports 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.
Speaker Change: The international literature some.
Novel work continuing to be generated by our team.
Speaker Change: Increasingly so.
Speaker Change: To support this.
Speaker Change: Central role the lectin pathway in these diseases as part of our efforts. We have developed an assay that can differentiate based on lectin pathway activation.
Speaker Change: Between those patients with mild COVID-19 and.
Speaker Change: With severe AAR DFS related COVID-19 requiring hospitalization.
Speaker Change: The assay also has potential applicability to patients with other forms of <unk> and patients with long COVID-19 as well.
Gregory A. Demopulos: In addition to our MASK2 and MASK3 antibody inhibitors and our SOPLIMAB, OMS906 and OMS1029, our complement franchise includes our developing small molecule, orally available MAP2 and MAP3 inhibitor programs, both of which are advancing rapidly. Our oral MASK-2 inhibitor is further ahead, and we are considering well-suited indications for clinical trials. Our oral MAF3 inhibitor program is quickly driving toward a drug development candidate, leveraging, in good part, all that we learned throughout our MASP-2 small molecule program.
Speaker Change: In addition to our mast two and masked antibody inhibitors in our <unk> 906, an LMS $10 29, our complement franchise includes our developing small molecule.
Speaker Change: Orally available mask to unmask <unk> inhibitor programs, both of which are advancing rapidly.
Speaker Change: Our oral <unk> inhibitor is further ahead and we are considering well suited indications for clinical trials.
Speaker Change: Our oral <unk> inhibitor program is quickly driving toward a drug development candidate leveraging in good part.
Speaker Change: All that we've learned throughout our mast two small molecule program.
Gregory A. Demopulos: Turning to OMS 527, our PD-7 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.
Speaker Change: Turning to <unk> $5, two seven <unk> seven inhibitor program aimed at treating addiction and compulsions.
Speaker Change: In movement disorders.
Speaker Change: Be directed request over the National Institute on drug abuse or neither.
Speaker Change: We're developing all of them as five to seven as a potential treatment for cocaine use disorder.
Speaker Change: So the program is funded by <unk> through a $6.7 million grant.
Gregory A. Demopulos: We anticipate receiving results later this year from a preclinical toxicology study of primates exposed to both cocaine and OMS-527. Depending on the positive results of the toxicology study, we plan to initiate 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 levofopa. And levodopa being the most common therapeutic used in Parkinson's disease. As such, LIB represents a large and effectively untapped commercial market.
Speaker Change: We anticipate receiving results later this year from a preclinical toxicology study of primates exposed to both cocaine and Oems five to seven.
Speaker Change: Assuming positive results in the toxicology study, we plan to initiate next year, a randomized double blind in patient clinical trial evaluating <unk> five to seven and individuals with cocaine use disorder.
Speaker Change: Also as referenced in last month's call, we're exploring the potential use of all of them as five to seven in movement disorders.
Speaker Change: Particularly levodopa induced dyskinesia or LRB.
Speaker Change: This is a major problem in patients treated with levodopa.
Speaker Change: And levodopa being the most common therapeutic used in Parkinson's disease.
Speaker Change: As such.
Speaker Change: <unk> represents a large and effectively untapped commercial market.
Gregory A. Demopulos: 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, and 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
Speaker Change: Our set of cellular and biologic immuno oncology platforms also have the potential to generate near term shareholder value.
Speaker Change: Following the recent generation of a large volume of exciting in vivo data. Our primary focus is on signaling driven immuno modulators antigen, driven immuno modulators that function, both as therapeutics and vaccines.
Speaker Change: <unk> and adoptive T cell therapy, which we believe could supersede car T.
Speaker Change: These platforms represent novel approaches to cancer treatment designed to target both cell surface and intracellular cancer targets for broad cancer applicability.
Speaker Change: To increase both CD, four and CD eight levels to mitigate loss of treatment effect seen with other therapies like checkpoint inhibitors.
Speaker Change: To eliminate the need for costly and time intensive cellular modification, our engineering and to create immune memory against future relapse.
Gregory A. Demopulos: 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 Jacobsen, our Chief Accounting Officer, to go through a more detailed discussion of our financial results. Mike? Thanks, Paul.
Speaker Change: We continue building out a broad intellectual property position and expect to share more of our data later this year.
Speaker Change: Now I'll turn the call over to Mike Jacobsen, Our Chief Accounting officer to go through a more detailed discussion of our financial results Mike.
Michael A. Jacobsen: Thanks, Greg.
Michael A. Jacobsen: Our net loss for the first quarter of 2024 was $37.2 million, or $0.63 per share, compared to a net loss of $9.1 million, or $0.15 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 for a measure of contract royalty asset due to the sale of the amyotrophic cell to VRI healthcare and also a $4.1 million gain on the early extinguishment of a portion of our 2026 dose.
Michael A. Jacobsen: Our net loss for the first quarter of 2024 was $37 $2 million or <unk> 63 per share compared to a net loss of $9 $1 million or <unk> 15 per share.
Michael A. Jacobsen: Last year's fourth quarter.
Michael A. Jacobsen: As Greg mentioned in the fourth quarter of last year, we had a remeasurement adjustment of $26 $2 million towards Madrid contact royalty asset.
Michael A. Jacobsen: Due to the liberalized itself, the DRA healthcare and also a $4 $1 million or being on the early extinguishment of a portion of our 2026.
Michael A. Jacobsen: 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 a $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. As of March 31st, we had $230 million of cash and investments on hand, an increase of $58 million from year-end.
Michael A. Jacobsen: Looking at <unk>, continuing operations, our net loss for the current quarter was $43 9 million or <unk> 75 per share compared with $39 3 million or <unk> 63 per share in the prior year quarter.
Michael A. Jacobsen: The prior year fourth quarter benefited from the $4 $1 million gain on the early extinguishment of the portion of the 'twenty six notes.
Michael A. Jacobsen: Without this ex the extinguishment transaction our loss from continuing operations for Q4, and Q1 would have been within $450000 of each other.
Michael A. Jacobsen: As of March 31, we had $230 million of cash and investments and an increase of 58 million from year end.
Michael A. Jacobsen: The two first quarter transactions significantly affected our Q1 ending cash balance, both 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 secondly, the repurchase of 3.2 million shares of our common stock for an aggregate purchase price of $11.9 million decreased our cash balance.
Michael A. Jacobsen: The two first quarter transaction significantly affected our Q1 ending cash balance.
Michael A. Jacobsen: Both on it.
Michael A. Jacobsen: On a positive basis for the DRA deal, which brought in $115 million of non dilutive 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.
Michael A. Jacobsen: And then secondly, the repurchases of $3 2 million shares of our common stock for <unk>.
Michael A. Jacobsen: <unk> purchase price of 11 9 million.
<unk> decreased our cash balance.
Michael A. Jacobsen: Combined with our common stock purchases in the fourth quarter of 2023, our total common stock repurchases to date are 5 million shares, or 8% of our outstanding common stock, for an aggregate purchase price of $16.5 million or $3.30 per share. Cost of expenses from continuing operations for the first quarter were $39 million, which was a decrease of $700,000 from the fourth quarter of last year. The decrease was driven by lower expenditures on the Igang clinical trial as we closed down the trial, and by lower manufacturing costs.
Michael A. Jacobsen: Combined with our common stock purchases in the fourth quarter of 2003, our total common stock repurchases to date are 5 million shares or 8% of our outstanding common stock.
Michael A. Jacobsen: For an aggregate purchase price of $16 5 million or $3 30 per share.
Michael A. Jacobsen: 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 omega royalty obligation. Interest and other income for the first quarter was $3.4 million, which was comparable to the fourth quarter of last year.
Michael A. Jacobsen: Cost and expenses from continuing operations.
Michael A. Jacobsen: For the first quarter was $39 million, which was a decrease of $700000 from the fourth quarter of last year. The decrease was driven by lower expenditures on the <unk> clinical trial as we closed down the trial and by lower manufacturing costs.
Michael A. Jacobsen: These decreases were.
Michael A. Jacobsen: Partially offset by higher compensation costs recorded in the first quarter.
Michael A. Jacobsen: 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 decreased interest associated with the <unk> transaction that was finalized in February.
Michael A. Jacobsen: 2024.
Michael A. Jacobsen: The primary drivers of interest expense again are the 2026 notes and the DRA omidria royalty obligation.
Michael A. Jacobsen: Interest and other income for the first quarter was $3 $4 million.
Michael A. Jacobsen: Which was comparable to the fourth quarter of last year.
Michael A. Jacobsen: Income from discontinued operations for this quarter was $6.7 million, which included two primary components: $4.3 million of interest earned on the immediate contract royalty asset and then $2.3 million of remeasurement adjustments related to the major contract royalty assets. As I've mentioned previously, royalties earned are recorded as a reduction in the immediate contract royalty asset on our balance sheet. Mid-range royalties for the first quarter were $9.4 million, and mid-range net sales were $31.2 million.
Michael A. Jacobsen: Income from discontinued operations for this quarter was $6 7 million.
Michael A. Jacobsen: <unk> two primary components.
Michael A. Jacobsen: $4 3 million of interest earned on the amended contract royalty asset.
Michael A. Jacobsen: And then $2 $3 million.
Michael A. Jacobsen: Measurement adjustments related to the major content royalty asset.
Michael A. Jacobsen: As I've mentioned previously royalties earned are recorded as a reduction in the immediate contract royalty asset on our balance sheet.
Michael A. Jacobsen: A major royalties for the first quarter were $9 4 million on Omidria net sales of $31 2 million.
Michael A. Jacobsen: 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's first quarter. The decrease in net cells is expected given that Q1 historically represents the lowest quarter annually for amydria net cells while Q4 is generally one of the, As Greg mentioned, in February this year, we entered into an amended agreement with DRI by which they acquired the right to receive all U.S. royalties payable by Raynor through December 31st of 2031. We continue to hold all royalty rights to the ex-U.S. cells of the Madrid and after December 31st, 2031.
Michael A. Jacobsen: 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.
Michael A. Jacobsen: Fourth quarter.
Michael A. Jacobsen: But it is a $500000 increase over the prior year first quarter.
Michael A. Jacobsen: The decrease in net sales is expected given that Q1, historically represents the lowest quarter annualized for Omidria net sales of Q4 is generally one of the.
Greg: As Greg mentioned in February this year, we entered into an amended agreement.
Greg: By which they acquired the right to receive all U S. A missouri royalties payable by Rainer through December 31, 2031.
Greg: We continue to hold all royalty rights to ex U S sales of Omidria.
Greg: And after December 31, 2031, all U S royalty payments will also accrue to Americas.
Michael A. Jacobsen: All U.S. royalty payments will also accrue to Omeros. 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 $115.5 million we received from DRI as incremental amity of royalty obligations on our balance. This is consistent with the counting of the initial transaction with DRR.
Greg: The U S royalty rate is generally 30% of <unk> net sales.
Greg: For the duration of the relevant patent terms, which we expect to be at least into.
Greg: Into 2035.
Greg: As I mentioned, we are also entitled now and going forward. So any non U S royalties, which are paid which are.
Greg: Generally 15% of net sales.
Greg: In the first quarter 'twenty 'twenty four we recorded the $115 $5 million received from Dr. <unk>.
Incremental immediate royalty obligation on our balance sheet.
Greg: This is consistent with the county of the initial transaction with Dr.
Michael A. Jacobsen: Now let's take a look at our expected second quarter results. We expect overall operating costs to continue operations in the first quarter. [inaudible] 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.
Greg: Now, let's take a look at our expected second quarter results.
Greg: We expect overall operating costs from continuing operations in the first quarter.
Greg: Our operations.
Greg: In the second quarter increased by about $16 million to $17 million in the first quarter. The increase was primarily due to the expected receipt of drug substance manufactured from one third party vendor versus which is expense upon deliberately to us.
Greg: As you May recall, we expense all manufacturing costs until we are reasonably assured of approval in the U S or the European Union.
Michael A. Jacobsen: Interest income for the second quarter should be nearly $3 million. Interest expense should be approximately $9 million, which is an increase of $800,000 over the first quarter. The increase in job spans is due to incremental interest recorded as a result of completing the DRI transaction.
Greg: Interest income for the second quarter should be nearly $3 million and.
Greg: And interest expense should be approximately $9 million.
Greg: Which is an increase of $800000 over the first quarter.
Greg: The increase is due to the incremental interest recorded as a result of completing the <unk> transaction.
Michael A. Jacobsen: Income from discontinued operations should be in the $7-$8 million range. With that, I'll turn the call back over to Greg.
Greg: Income from discontinued our operator operations should be in the $7 million to $8 million range.
Greg: I will turn the call back over to Greg Greg.
Gregory A. Demopulos: Okay, thanks Mike. Operator, let's please open the call to questions.
Greg: Okay. Thanks, Mike.
Operator.
Speaker Change: Please open the call to questions.
Operator: Certainly. Ladies and gentlemen, if you do have a question at this time, please press star 11 on your telephone. If your question has been answered and you'd like to remove yourself from the queue, simply press star 11 again. Our first question comes from the line of Steve Brozak from WBB Securities. Your question, please.
Speaker Change: Certainly ladies and gentlemen, if you do have a question at this time. Please press star one on your telephone. If your question has been answered and you'd like to move yourself from the queue simply press star one again.
Speaker Change: First question comes from the line of Steve Brozak from <unk> Securities. Your question. Please.
Stephen Gilbertpaul Brozak: 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.
Speaker Change: Okay.
Stephen Gilbertpaul Brozak: Hi, Greg. Thank you for taking the call. Just one quick question on 900, <unk> you were pretty extensive in how you describe the therapeutic.
Stephen Gilbertpaul Brozak: Window and how it work, but tell me something what are the kols.
Stephen Gilbertpaul Brozak: Giving you in terms of information.
Stephen Gilbertpaul Brozak: On what they see and how important this will be and then I've got one follow up after that thank you.
Gregory A. Demopulos: 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, the response to the market research done today, which included positions, and within that position group, key opinion leaders, has been consistently positive. And as I mentioned, that's really been driven by two primary factors.
Speaker Change: Okay well.
Speaker Change: Let me first take.
Speaker Change: Take that and then I think I'll hand, it off to.
Speaker Change: Sure.
Speaker Change: Clinical and commercial as well, but I think as we've said in the prepared comments that the response.
Speaker Change: With the market research done today, which has included.
Speaker Change: Physicians and within that position group key opinion leaders.
Speaker Change: <unk> has been consistently positive.
Speaker Change: As I mentioned, that's really been driven by two primary factors one is the.
Gregory A. Demopulos: 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 every three months 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 that physicians are then comfortable, they're confident, and they know that the patients are in fact complying with treatment.
Gregory A. Demopulos: They know it because they're administering the treatment. So those are all seen as, I think, very positive attributes. I think that, you know, 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, And we think the response from physicians has also been that that's positive. But let me stop there. And I think first, let me ask clinical questions and then follow up with commercial.
Speaker Change: The data today.
Speaker Change: To date.
Speaker Change: And based on the data to date.
Speaker Change: Expected efficacy they anticipated efficacy.
Speaker Change: <unk> 906.
Speaker Change: In patients and the second is is it dosing ability, meaning every other month to once quarterly dosing that represents.
Speaker Change: A significant reduction.
Andreas Grauer: Andreas, do you have anything to add? Or Steve, anything to add to that?
Speaker Change: In patient burden.
Speaker Change: It coincides with how physicians follow their patient so that physicians can then administer the drug and the importance of that as physicians then are comfortable they're confident they know that the patients.
Speaker Change: Or in fact complying with treatment they know it because they are administering the treatment.
So those those are all seen as I think very positive attributes.
I think that.
Speaker Change: Certainly.
Speaker Change: When you think about how patients would view this.
Speaker Change: Taking some sort of an infusion whether it's <unk>, whether it's IV. Once every other month once quarterly they're not consistently.
Speaker Change: And repeatedly reminded that they're sick.
Speaker Change: They go and have the infusion they walk away they live their lives as they otherwise would lift.
Speaker Change: And taking taking an oral medication.
Speaker Change: Once daily certainly twice daily as a constant reminder, I think to patients that's.
Speaker Change: GE. There is there is a problem here with which I have the deal.
Sure.
Speaker Change: My whole life.
Speaker Change: And.
Andreas: We think the response also from physicians has been that's that's a positive but let me stop there and I think first let me ask clinical and then follow up with commercial Andreas.
Speaker Change: Steve anything to add.
Andreas Grauer: I think the consideration, you mentioned the twice-oral treatment, that is obviously great, it's convenient for many, but I think you have gastrointestinal upset, you have diarrhea, you travel in 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.
Speaker Change: Consideration you mentioned twice a treatment that is obviously great is convenient for menu but.
Speaker Change: Thank you.
Speaker Change: Yes.
Speaker Change: <unk> said diarrhea travel different time zones, there complications that make this simple supposedly simple regimen not quite that simple.
Speaker Change: Taking something every other month or every quarter and not having to worry about it in the meantime.
Speaker Change: Is attractive.
Attractive.
Speaker Change: We are a significant number of patients and physicians because they will know that they have Kevin.
Unnamed Speaker: Do you have anything more to add from the clinical on that? No.
Speaker Change: Yes.
Speaker Change: Clinical lab.
Unnamed Speaker: I think everything has 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 will be attractive to trial providers.
Speaker Change: I think it's been well.
Speaker Change: I haven't encountered anything but enthusiasm when talking to kols from talking to physicians, who treat these patients potentially clinical sites, we're seeing no problems with this regimen and think it will be attracted to.
Speaker Change: Two trial participants.
Unnamed Speaker: 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, doctors are telling us patients need options, and they're very encouraged by what they're seeing, both efficacy and what's 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. 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.
Speaker Change: Sure.
Speaker Change: Yes.
We are in the middle of our extensive market Research center is so exciting to hear the reactions to the product profile for <unk>.
Stephen Gilbertpaul Brozak: 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.
Speaker Change: Bottom line, the doctor's accounting as patients need options and they are very encouraged by what they're seeing.
Speaker Change: Efficacy that's 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 and the market research capacity later this month and continue this work.
Speaker Change: Thank you. Thank you so Steve I think you said you had a follow up but I don't know we may or we may have answered that already for you, but let us know.
Speaker Change: You actually did asked and answered but I appreciate the detail on that.
Speaker Change: You went into let me hop back into queue. Thanks very much.
Speaker Change: Okay. Thank you.
Operator: Thank you. One moment for our next question. And our next question comes from the line of Olivia Brayer from Catch Fitzgerald. Your question, please. Hey, good afternoon.
Speaker Change: Thank you one moment for our next question.
Speaker Change: And our next question comes from the line of Olivia Brayer from Cantor Fitzgerald. Your question. Please.
Olivia Simone Brayer: Hey, good afternoon guys. Thank you for the question. For the OMS 906 update coming, I wanted to clarify that the data we'll see at EHI is just through week 24, and the final switchover portion of the trial is later in the year. Is that right?
Olivia Simone Brayer: Hey, good afternoon, guys. Thank you for the question for the LMS nine or six update coming wanted to clarify that the data we'll see at <unk>.
Speaker Change: Is just through week 24, and that final switchover portion of the trial is later in the year.
Olivia Simone Brayer: And then maybe just help frame what level of efficacy you're looking to see later in the year from that monotherapy portion specifically.
Speaker Change: Is that right and then maybe just help frame what level of Asquith QC your.
Looking to see later in the year from that monotherapy question specifically.
Gregory A. Demopulos: Sure. First, in answer to your initial question, yes, it's through the first 24 weeks. So we are 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 what 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 rabializumab. But let me look at the clinical data and see if they have other things to add to that.
Speaker Change: Sure.
Speaker Change: First an answer to your initial question, yes, it's through the first 24 weeks. So its 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.
Speaker Change: With respect to what specifically, we're targeting on the monotherapy side I think that.
Speaker Change: And again I'll turn this to clinical but I can tell you what 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 <unk> Bob.
Speaker Change: Let me, let me look to clinical and see if they have other things to add to that.
Gregory A. Demopulos: 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 it was made public.
Speaker Change: I think that we are.
Speaker Change: Looking for data that are.
Speaker Change: At least comparable to those of other switch studies that have been reported.
Speaker Change: The abstract I'm sure you know is now available online I think it came out yesterday or the day before it was made public.
Gregory A. Demopulos: And in that abstract, we note that in our high dose group in that study, we looked at two different dose groups, a dose escalation study, but in the high dose group, all of the patients treated at the high dose achieved a clinical response of 100%. That's a two 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.
Speaker Change: And in that abstract we note that the.
Speaker Change: And our high dose group in that study, we looked at two different dose groups dose escalation study.
Speaker Change: But in the high dose group all of the patients treated at the high dose achieved clinical response.
Speaker Change: It's 100%.
Speaker Change: Two gram per deciliter increase in hemoglobin, which was one of the primary or co primary endpoints the attack a pan filings certainly compares favorably to other switch studies.
Gregory A. Demopulos: Even in the low dose, I think 607 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 3 and, frankly, completing our Phase 3 program and bringing OMS 906 to market.
Speaker Change: And even in the low dose <unk> 607 achieved that right. So we're quite we're quite happy with.
Speaker Change: With how the data are looking with how 906 is looking generally.
Speaker Change: We're we think the data are impressive they continue to be impressive.
Speaker Change: And we're just looking forward to initiating phase III and frankly, completing our phase III program and bring in RMS 906 to market.
Olivia Simone Brayer: Thank you both. I am looking forward to those updates.
Bob: Thank you Bob looking forward to those updates.
Operator: All right, thank you, Olivia. Thank you. One moment for our next question, and our next question comes from the line of John Cianco from Needham & Company. Your question, please.
Speaker Change: Alright, Thank you Olivia.
Speaker Change: Thank you one moment for our next question.
Speaker Change: And our next question comes from the line of John <unk> from Needham <unk> Company. Your question. Please.
John Cianco: Hi, everyone. Thanks for taking my questions. I'm on for Serge today.
Speaker Change: Okay.
John: Hi, everyone. Thanks for taking my questions.
John: Percentage today.
John Cianco: 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 Narsoplimab, the LA 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? Yes, in answer to your first question, discussions and interactions are ongoing with
John: First regarding the RMS six trials can you provide any color on when we can expect after the data is released.
John: Particularly whether we can expect meetings with the FDA.
John: Ahead of the phase III initiation.
John: And then second regarding the supplemental BLA Resubmission, obviously, you mentioned updates or soon to come.
Can you can you give any context to progress made with the FDA. Since you last received an update in April.
Speaker Change: We're kind of at the ball is in their hands at this time.
Gregory A. Demopulos: Yes, in answer to your first question, discussions and interactions are ongoing with both US and European regulators as we prepare for the phase three trial or phase three program. So, let me just turn to Kathy and see if she can add more color to that.
Speaker Change: Yes in answer to your first question.
Speaker Change: Discussions interactions are ongoing with both U S and European regulators as we prepare for the phase III trial or phase III program. So let me just turn to Kathy and Kathy can.
Speaker Change: Can you add more color to that.
Catherine A. Melfi: Yeah, I mean, it's really fairly standard. And we are making sure that we are keeping the communication lines open in both the US 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.
Kathy: Yes, I mean, it really is.
Kathy: Fairly standard and we are making sure that we are keeping that communication lines open and the U S and Europe and trying to harmonize those as much as we can so that we have a very efficient phase III program.
Gregory A. Demopulos: And in answer to your second question, we really are not and have not, and do not provide any 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 and confident in the data that we have. We believe the drug certainly warrants approval, and that is our objective.
Speaker Change: Okay. Thank you.
Speaker Change: And answer to your second question.
Speaker Change: We really are not and have not do not.
Speaker Change: Provide sort of running commentary on our interactions with regulators. So there's not much that I have to say there other than.
Speaker Change: We clearly are comfortable confident.
Speaker Change: In the data that we have we believe the drug certainly warrants approval and that is our objective.
Gregory A. Demopulos: When you look at the utilization of the drug across compassionate use, or what is more formally called the Expanded Access Program, you know, the data are really very clear, and we're eager to get the drug approved. There is no drug approved for this indication.
Speaker Change: When you look at the utilization of the drug across the compassionate use or what is more formally.
Speaker Change: Called the.
Speaker Change: Expanded access program.
Speaker Change: The data are really very clear.
Speaker Change: We're eager to get the drug approved there is no drug approved for this indication.
Gregory A. Demopulos: 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, you know, 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 deserves it.
Speaker Change: We think it compares very favorably.
Speaker Change: Two other agents that are currently being used.
Speaker Change: Off label.
Speaker Change: In this indication.
Speaker Change: And we're hearing similar things quite quite widely from physicians, both in the U S and international.
So it's been a long time, we recognize that.
Speaker Change: But our expectation certainly our strong hope and expectation is that we will get this approved it certainly warranted.
Operator: Thank you. This does conclude the question and answer session for today's program. I'd like to hand the program back to Dr. Demopulos for any further remarks.
Speaker Change: Thank you.
Speaker Change: Does conclude the question and answer session of today's program I'd like to hand, the program back to Dr. Michael <unk> for any further remarks.
Gregory A. Demopulos: Thank you, operator. And again, thank you all for joining us 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.
Michael A. Jacobsen: Thank you operator and again, thank you all for joining this afternoon.
Speaker Change: I'm pleased with our first quarter progress across our programs and believe that we are well positioned.
Speaker Change: For continued success throughout the remainder of 2024 and beyond.
Speaker Change: So we look forward to bringing you future updates and as always we appreciate your continued support.
Speaker Change: Have a good afternoon.
Operator: Thank you, ladies and gentlemen, for your participation in today's conference. This does conclude the program. You may now disconnect. Good day.
Speaker Change: Thank you, ladies and gentlemen for your participation in today's conference. This does conclude the program you may now disconnect good day.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Sure.
Yes.
Speaker Change: Okay.