Q2 2024 Omeros Corp Earnings Call

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Unknown Executive: Hello, everyone, and thank you for joining us. We will begin the call in just a few moments. Please stand by.

Hello.

Speaker Change: Thank you for joining us we will begin the call in just a few moments.

Speaker Change: These standby.

Speaker Change: Yeah.

Jennifer Williams: Good afternoon and welcome to today's earning call for Omeros Corporation. At this time, all participants are in a listen-only mode. After the company's remarks, we will conduct a question-and-answer session.

Speaker Change: Good afternoon, and welcome to today's earning call for Meredith Corporation.

Speaker Change: At this time all participants are in a listen only mode.

Speaker Change: After the company's remarks, we will conduct a question and answer session.

Jennifer Williams: 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: 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.

Jennifer Williams: I'll turn the call over to Jennifer Williams, Investor Relations for Omeros. 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.

Unknown Executive: I'll turn the call over to Jennifer Williams, Investor Relations for Omeros.

Speaker Change: I'll turn the call over to Jennifer Williams Investor Relations for Marin.

Jennifer 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 app.

Jennifer Williams: All forward-looking statements involve risks and uncertainties that could cause the company's actual results to differ materially. Please refer to the special note regarding forward-looking statements in the company's quarterly report on Form 10-Q, which was filed today with the SEC, and the Risk Factors section of the company's most recent annual report on Form 10-K for a discussion of these risks and uncertainties.

Jennifer Williams: So our results to differ materially.

Jennifer Williams: Please refer to the special note regarding forward-looking statements in the company's quarterly report on Form 10-Q, which was filed today with the SEC, and the risk factors section of the company's most recent annual report on Form 10-K for a discussion of these risks and uncertainties.

Jennifer Williams: Please refer to the special note regarding forward looking statements in the company's quarterly report on Form 10-Q, which was filed today with the SEC and the risk factors section of the company's most recent annual report on Form 10-K for a discussion of these risks and uncertainties now.

Gregory Demopulos: Now I would like to turn the call over to Dr. Greg Simopoulos, Chairman and CEO of Omeros. Thank you, Jennifer, and good afternoon, everyone. I'm joined on today's call by David Borges, our Chief Accounting Officer, Nadia Doc, our Chief Commercial Officer, Andreas Grower, our Chief Medical Officer, Kathy Melfi, our Chief Regulatory Officer, and Steve Whitaker, our Clinical Vice President. I'll start today with an overview and discussion of our 2024 second quarter financial results, followed by an update on our ongoing development program. David will then provide a more detailed financial summary before we open the call to questions.

Speaker Change: Now I would like to turn the call over to Dr. Greg to Mark Lewis, Chairman and CEO of Amerigas.

Mark Lewis: Thank you Jennifer and good afternoon, everyone I'm joined on today's call by David <unk>, Our Chief Accounting Officer.

Doc: Doc our chief commercial officer.

Speaker Change: <unk> Grauer, our Chief Medical Officer, Cathy Melfi, our Chief regulatory officer, and Steve would occur or clinical Vice president.

Gregory Demopulos: I'll start today with an overview and discussion of our 2024 second quarter financial results, followed by an update on our ongoing development program. David will then provide a more detailed financial summary before we open the call to questions. Now let's look at our financial results for the second quarter. Our net loss for the second quarter of 2024 was $56 million, or $0.97 per share, compared to a net loss of $37.2 million, or $0.63 per share, in the first quarter of 2024.

Speaker Change: I'll start today with an overview and discussion of our 2024 second quarter financial results, followed by an update on our ongoing development programs.

Speaker Change: David will then provide a more detailed financial summary.

Speaker Change: Before we open the call to questions.

Gregory Demopulos: Now let's look at our financial results for the second quarter. Our net loss for the second quarter of 2024 was $56 million, or 97 cents per share, compared to a net loss of $37.2 million, or $63 cents per share in the first quarter of 2024. In the second quarter, we incurred $17.6 million of R&D expense related to the manufacture of Narsoplamab drug substance lots that commenced in October 2023. $21.2 million in discounted term loan-related debt repurchase, and $1.9 million of term loan-related transaction costs. These significant cash outlets representing a total of $40.7 million are not expected to be repeated in the foreseeable future.

Gregory Demopulos: In the second quarter, we incurred $17.6 million of R&D expenses related to the manufacture of Narsoplimab drug substance lots that commenced in October 2023. As of June 30, 2024, we had $158.9 million of cash and investments on hand. In addition, as explained in earlier calls, our recent sale of Omidria Royalties to DRI Healthcare carries with it two sales contingent milestones payable by DRI to Omeros, each up to $27.5 million with payment dates in January 2026 and January 2028.

David: Now, let's look at our financial results for the second quarter.

David: Our net loss for the second quarter of 2024 was $56 million or 97 cents per share compared to a net loss of $37 $2 million or <unk> 63 per share in the first quarter of 2024 in the second quarter, we incurred $17 6 million.

David: Of R&D expense related to the manufacture of our supplementary drug substance lots that commenced in October 2023.

David: $21.2 million in discounted term loan related debt repurchase.

David: And $1 $9 million of term loan related transaction costs. These significant cash outlays are representing a total of $47 million are not expected to be repeated in the foreseeable future.

Gregory Demopulos: As of June 30, 2024, we add $158.9 million of cash and investments on hand. In addition, as explained in earlier calls, our recent sale of omitria royalties to DRI Health Care carries with it two sales contingent milestones payable by DRI to Omeros, each up to $27.5 million, with payment dates in January 2026 and January 2028. In the second quarter, we substantially strengthened our balance sheet through our debt repurchase and exchange transaction. At March 31, 2024, we add $216 million in noional value outstanding on our 2026 notes, all maturing in February 2026. In June, we entered into an agreement with Ethereum Capital Management and Hybrid Capital Management, under which we repurchased and retired 2026 notes held by Ethereum and by Hybrid, representing a collective notional value of $118.1 million for $21.2 million in cash and $67.1 million in a new secured term loan with maturity extended out to June of 2028.

David: As of June 32024, we had $158 $9 million of cash and investments on hand. In addition, as explained in earlier calls our recent sale of Omidria royalties to Eri health care carries with it to sales contingent milestones.

Speaker Change: Payable by <unk> to <unk>, each up to $27 $5 million with payment dates in January 2026 in January 2028.

David: In the second quarter, we substantially strengthened our balance sheet through our debt repurchase and exchange transaction.

Gregory Demopulos: At March 31, 2024, we had $216 million in notional value outstanding on our 2026 notes, all maturing in February 2026, for $21.2 million in cash and $67.1 million in a new secured term loan with maturity extended out to June of 2028. We view the outcome of the transaction as highly favorable to Omeros for the following reasons. The transaction was completed at approximately 75% apart, so rather than being priced at the typical 10 to 15% premium above the prevailing market, our transaction was priced slightly below the market, and it is non-dilutive for Omeros with no common stock or warrants included. The interest rate on the new term loan is highly competitive, resulting in a lower cash outflow.

David: At March 31, 2024, we had $216 million in notional value outstanding on our 2026 notes all maturing in February 2026.

David: In June we entered into an agreement with a theory on capital management, and Highbridge capital management under which we repurchased and retired five.

David: 'twenty six notes held by a theory and by Highbridge.

David: Presenting a collective notional value of $118 1 million.

David: For $21 2 million in cash and $67 1 million and a new secured term loan with maturity extended out to June of 2028.

Gregory Demopulos: The total of $88.3 million in cash paid and new term loan represents a discount of approximately 25% or $29.8 million off of par. This transaction brings our remaining 2026 notes down by 55%. from 216 million to a much more manageable $98 million, with the option at Omeros' discretion to reduce that amount by another $15 million in notional value with additional lenders. We view the outcome of the transaction as highly favorable to Omeros for the following reasons. Through both the restructuring and repurchase of $118.1 million of our outstanding 2026 notes, we extinguished nearly $30 million of debt through financial engineering alone.

David: A total of $88 3 million in cash paid in new term loan represents a discount of approximately 25%.

David: Our $29 $8 million offer par.

David: This transaction brings our remaining 2026 notes down by 55%.

David: From $216 million to a much more manageable $98 million with the option at <unk> discretion.

David: Reduced that amount by another $15 million in notional value with additional lenders.

David: We view.

David: The outcome of the transaction.

David: The highly favorable two <unk> for the following reasons.

David: Through both the restructuring and repurchase $118 $1 million of our outstanding 2026 notes.

David: We extinguished nearly $30 million of debt through financial engineering alone.

Gregory Demopulos: The transaction was completed at approximately 75% a par, so rather than being priced at a typical 10 to 15% premium above the prevailing market, our transaction was priced slightly below the market. We've further de-risked the balance sheet with the majority of our debt now extinguished or having its maturity profile extended from February 26 to June 2028. Again, unusual for this type of transaction, the deal is non-dilutive for Omeros with no common stock or warrants included. The interest rate on the new term loan is highly competitive, resulting in a lower cash outflow than our prior principal and interest payments on the retired 2026 notes.

David: The transaction was completed at approximately 75% of par.

David: So rather than being priced at the typical 10% to 15% premium above the prevailing market our transaction was priced slightly below the market.

David: We've further derisked the balance sheet with the majority of our debt now extinguished or having its maturity profile.

David: Extended from February 26 to June 2028.

David: Again unusual for this type of transaction the deal is non dilutive for our Melrose with no common stock or warrants included.

David: The interest rate on the new term loan is highly competitive resulting in a lower cash outflow.

David: And then our prior principal and interest payments on the retired 'twenty 'twenty six notes.

Gregory Demopulos: Omeros also retains the ability to spend up to $25 million to repurchase additional outstanding 2026 notes. In addition, as I mentioned a bit earlier, Omeros has the option to allow other lenders to join the transaction to a total of an additional $15 million of notional value, provided that they are given terms no better than those received by Ethereum and hybrid. The term loan agreement also includes an additional commitment by the lenders to fund a $25 million delayed draw facility at our request prior to July 3, 2025, contingent on FDA approval of our SOPLIMAB in TATMA.

Gregory Demopulos: Omeros also retains the ability to spend up to $25 million to repurchase additional outstanding 2026 notes. In addition, as I mentioned a bit earlier, Omeros has the option to allow other lenders to join the transaction for a total of an additional $15 million of notional value, provided that they are given terms no better than those received by Ethereum and its hybrids. The term loan agreement also includes an additional commitment by the lenders to fund a $25 million delayed draw facility at our request prior to July 3, 2025, contingent on FDA approval of narsoplimab in TATMA, to reduce the remaining balance of our outstanding 2026 notes and or to reduce the outstanding balance on our term loans, thereby reducing by more than half the outstanding principal amount of our 2026 maturing debt to a substantial discount to par value

David: <unk> also retains the ability to spend up to $25 million to repurchase additional outstanding 2026 notes.

David: In addition, as I mentioned a bit earlier on Melrose has the option to allow other lenders to join the transaction to a total of an additional $15 million of notional value provided that they are given terms no better than those received by a theory.

David: And Highbridge.

David: The term loan agreement also includes an additional commitment by the lenders to fund <unk>.

David: $25 million delayed draw facility at our request.

David: Prior to July 3rd 2025 contingent on FDA approval of our <unk> and Ta TMA.

Gregory Demopulos: This additional commitment provides Omeros with a ready source of capital to fuel in our SOPLIMAB's early commercialization while preserving our cash to fund program development to reduce the remaining balance of our outstanding 2026 notes and/or to reduce the outstanding balance on our term loan. As part of this transaction, we also retain all future value of the cap calls associated with all the 2026 notes, including those retired in the debt repurchase and exchange. Collectively, these cap calls represent substantial potential value.

David: This additional commitment.

David: <unk> with a ready source of capital to fuel our supplement ebbs early commercialization, while preserving our cash to fund program development.

David: To reduce the remaining balance of our outstanding 2026 notes and or to reduce the outstanding balance on our term loan.

David: But as part of this transaction, we also retain all future value of the cap calls associated with all the 'twenty to 'twenty six notes, including those retired and the debt repurchase and exchange collectively these cap calls represent substantial potential value.

Gregory Demopulos: In summary, our recent debt repurchase and exchange non-dilutably reduces by more than half the outstanding principal amount of our 2026 maturing data to substantial discount to parability, replacing a portion of that outstanding debt with a term loan maturing out in June of 2028 and also provides funding flexibility to manage the remaining lesser balance of our 2026 notes to fund the early commercialization of Narsoplamab and to continue advancing through upcoming shareholder value driving catalysts within our development programs. Building on our earlier retirement of 9.1 million national value of our 2026 notes and our recent open market purchases and return to our treasury.

David: In summary, our recent debt repurchase and exchange non dilutive way.

David: Reduces by more than half the outstanding principal amount of our 2026 maturing data at a substantial discount to par value.

David: Replacing a portion of that outstanding debt with a term loan maturing out in June of 2028.

David: And also provides funding flexibility to manage the remaining a lesser balance of our 2026 notes to fund the early commercialization of <unk> and to continue advancing through upcoming shareholder value driving catalysts within our developers.

David: <unk> programs.

Gregory Demopulos: Building on our earlier retirement of 9.1 million notional value of our 2026 notes and our recent open market purchases and return to our treasury of 8% of Omeros' outstanding common stock, this transaction with Ethereum and hybrids represents another substantial step in managing our capital structure to remove financial overhang. Another upcoming meeting has been scheduled with FDA. In the meantime, we're preparing the BLA for resubmission, although acknowledging that developing therapies for these conditions is often particularly challenging.

David: Building on our earlier retirement of $9 1 million notional value of our 2026 notes and our recent open market purchases.

David: And return to our treasury of 8% of <unk> outstanding common stock this transaction with a theory of hybrids represents.

Gregory Demopulos: Of 8% of Omeros' outstanding common stock, this transaction with Ethereum and hybrid represents another substantial step in managing our capital structure to remove financial overhang.

David: Another substantial step in managing our capital structure to remove financial overhang.

Gregory Demopulos: With that, let's move on to an update on our development programs. I'll begin with Narsoplamab, our Mass 2 inhibitor targeting the lectin pathway of complement. As I described in our last earnings call and at our annual shareholder meeting in June, we continue to engage with the FDA regarding the proposed resubmission of our Biologics License Application or BLA for Narsoplamab in hematopoietic stem cell transplant-associated thrombotic microangiopathy or TAPMA. Another upcoming meeting has been scheduled with FDA. In the meantime, we're preparing the BLA for resubmission. We're further encouraged by FDA's recent establishment of the Rare Disease Innovation Hub, which will serve as a single point of connection and engagement with in the FDA to promote and support the development of therapeutics for rare diseases.

Speaker Change: With that let's move on to an update on our development programs I'll begin with <unk>, our mast two inhibitor targeting the lectin pathway of complement.

Speaker Change: As I described on our last earnings call and at our annual shareholder meeting in June we continue to engage with FDA regarding the proposed re submission of our biologics license application or BLA for in our supplement and hematopoietic stem cell transplant associated thrombotic microangiopathy.

David: Year Ta TMA.

David: Another upcoming meeting has been scheduled with FDA in the meantime, we're preparing the BLA for Resubmission.

David: We're further encouraged by Fda's recent establishment of the rare disease innovation hub.

David: Which will serve as a single point of connection and engagement with the FDA to promote.

David: And support the development of therapeutics for rare diseases.

Gregory Demopulos: The hub is designed to focus especially on rare diseases for which the natural history is variable and not fully understood. Recognizing that development of therapies for these conditions is often particularly challenging. Regarding our plans for resubmission and its anticipated timing, we will provide a further update when more definitive information from our FDA interactions becomes available. Also, in addition to the publications already available, two more manuscripts authored by international transplant experts are in preparation. One directed to the results of a survival comparison between our pivotal TAPMA trial and a rigorous external control. and the second detailing the survival data in our expanded access program.

David: The hub is designed to focus, especially on rare diseases for which the natural history is variable and not fully understood.

David: Recognizing that development of therapies for these conditions as often particularly challenging.

Gregory Demopulos: Regarding our plans for resubmission and its anticipated timing, we will provide a further update when more definitive information from our FDA interactions becomes available, including one directed to the results of a survival comparison between our pivotal TATMA trial and a rigorous external control, and the second detailing the survival data in our Expanded Access Program. We have multiple phase two studies of Xaltenabart ongoing in two rare disease indications, paroxysmal nocturnal hemoglobinuria, or PNH, a life-threatening hematologic disorder, and complement three glomerulopathy, or C3G, a debilitating and potentially life-threatening kidney disease.

Speaker Change: Regarding our plans for Resubmission and its anticipated timing.

David: We will provide a further update when more definitive information from our FDA interactions becomes available.

David: Also in addition to the publications already available two more manuscripts authored by international transplant experts are in preparation.

David: One directed to the results of a survival comparison.

David: Between our pivotal Ta TMA trial, and a rigorous external control.

David: And the second detailing the survival data and our expanded access program.

Gregory Demopulos: Physicians continue to increasingly request Narsoplameth under expanded access for their patients with TATMA. Given that there is no approved treatment for this life-threatening condition, we continue to do what we can to help these patients.

David: Physicians continue to increasingly requests in our sample amounts under expanded access for their patients with Ta TMA.

David: Given that there is no approved treatment for this life threatening condition.

David: We continue to do what we can to help these patients.

Gregory Demopulos: In parallel with our efforts to obtain FDA approval for Narsoplameth, we continue rapidly advancing the clinical development program for our mass-free inhibitor targeting the alternative pathway of complement. OMS 906, our lead mass-free antibody, now has a recently adopted non-proprietary name, Zaltenobart. We have multiple phase two studies of Zaltenobart ongoing in two rare disease indications: paroxysmal nocturnal hemoglobinuria, or PNH, a life-threatening hematologic disorder, and complement three glomerulopathy, or C3G, a debilitating and potentially life-threatening kidney disease. We'll look first at our ongoing Phase Two PNH clinical trial. The annual European Hematology Association Congress in June, Dr. Mora Agrippin, an internationally recognized PNH expert from St.

David: In parallel with our efforts to obtain FDA approval for in our supplement we continue rapidly advancing the clinical development program for our mass <unk> inhibitor targeting the alternative pathway of complement.

David: <unk> 906, our lead masked three antibody now has a recently adopted non proprietary name <unk>.

Speaker Change: All 10 of art.

David: We have multiple phase III studies of <unk> ongoing in two rare disease indications paroxysmal nocturnal hemoglobinuria or <unk>, a life threatening hematologic disorder and complement three preliminary allopathy or C. III G <unk>.

David: <unk> and potentially life threatening kidney disease.

David: Well look first at our ongoing phase two <unk> clinical trial.

Gregory Demopulos: At the annual European Hematology Association Congress in June, Dr. Morag Griffin, an internationally recognized PNH expert from St. James University Hospital in the UK, presented the results of the adjunctive treatment stage of our switchover study in PNH patients with a suboptimal response to treatment with the C5 inhibitor raviolizumab. During the adjunctive therapy period, the statistically significant mean hemoglobin improvement from baseline was 3.27 grams per deciliter, and 10 of 12 patients advanced to monotherapy. And consistent with our clinical experience with Xeltenabart, the drug was safe and well tolerated.

David: The annual European Hematology Association Congress in June.

Speaker Change: Doctor Mora Griffin and internationally recognized <unk> H expert from St. James University Hospital in the UK.

Gregory Demopulos: James University Hospital in the UK presented the results of the adjunctive treatment stage of our switchover study in PNH patients with a suboptimal response to treatment with the C5 inhibitor ravillizumab. The study evaluated two Zaltenobart dose levels. As previously discussed, patients in this study began adjunctive Zaltenobart treatment while receiving ravillizumab, and then those patients adequately responding to combination treatment were switched to Zaltenobart monotherapy. During the adjunctive therapy period, the statistically significant mean hemoglobin improvement from baseline was 3.27 grams per deciliter, and 10 of 12 patients advanced to monotherapy. Absolute reticulous eye count also demonstrated statistically significant improvement, and consistent with our clinical experience with Zaltenobart, of the drug was safe and well tolerated.

David: Bob presented the results of the adjunct treatment stage of our switchover study in <unk> patients with a suboptimal response to treatment with the C. Five inhibitor Ravi Iliza map.

David: The study evaluated to zelle 10 of our dose levels.

David: As previously discussed patients in this study began adjunct to sell 10 of our treatment, while receiving raviolis from App and then.

David: Those patients adequately responding to combination treatment were switched to <unk> monotherapy.

David: During the adjunctive therapy periods, a statistically significant mean hemoglobin improvement from baseline was 327 grams per deciliter, and 10 or 12 patients advanced to monotherapy.

David: Absolute reticulocyte count also demonstrated statistically significant improvement.

David: And consistent with our clinical experience with all 10 of our of the drug was safe and well tolerated.

Gregory Demopulos: The last patient visit in this switchover study is scheduled for October, and patients completing the study are entering our long-term extension study. An abstract providing results of these Zaltenobart monotherapy stage has been submitted to the American Society of Hematology for presentation as their annual meeting in December. The efficacy and safety profiles of Zaltenabart as monotherapy remain strong, including demonstration of sustained and clinically meaningful improvements in hemoglobin levels and absolute ridiculous eye counts, as well as prevention of extravascular and intravascular homolysis. We look forward to sharing these data with you later this year. Our second ongoing phase to PNH study continues to progress well.

Gregory Demopulos: The last patient visit in this switchover study is scheduled for October, and patients completing the study are entering our long-term extension study. After presentation of the early results of subcutaneous alzheimer's treatment at the 2023 American Society of Hematology meeting last December, these data, together with data derived from our switchover PNH study and from our Phase I studies in healthy subjects, provide the basis for selecting these Altenobar doses for our upcoming Phase III clinical trials.

David: The last patient visit in this switchover study is scheduled for October and patients completing the study are entering our long term extension study.

David: An abstract providing results of these all 10 of our monotherapy stage has been submitted to the American Society of Hematology for presentation at their annual meeting in December.

David: The efficacy and safety profiles of <unk> as monotherapy remains strong.

David: Including demonstration of sustained and clinically meaningful improvements in hemoglobin levels in absolute reticulocyte counts as well as prevention of extra vascular and Intravascular hemolysis.

David: We look forward to sharing these data with you.

David: Later this year.

David: Our second ongoing phase III <unk> study continues to progress well.

Gregory Demopulos: This one is in patients who are naive to complement inhibitor treatment, meaning that they have not received previous complement therapy. After presentation of the early results of subcutaneous Zaltenabart treatment at the 2023 American Society of Hematology meeting last December, we amended the study protocol to identify the plasma concentrations and the level of mass-three inhibition required to inhibit breakthrough homolysis. These data are together with data derived from our switchover PNH study and from our phase one studies, in healthy subjects, provides a basis for selecting these Zaltenabart dose for our upcoming three clinical trials. We now have the needed data to finalize our phase three dose selection and analyses that will be completed soon.

David: This one is in patients who are naive to complement inhibitor treatment meaning.

David: They have not received previous complement therapy.

David: After presentation of the early results of subcutaneous <unk> treatment at the 2023 American Society of Hematology meeting last December.

David: We amended the study protocol to identify the plasma concentrations and the level of mastery inhibition required to inhibit breakthrough hemolysis.

David: These data together with data derived from our switchover PSNH study and.

David: From our phase one studies in healthy subjects provides the basis for selecting these all 10 of our dose for our upcoming phase III clinical trials.

Gregory Demopulos: We now have the needed data to finalize our phase 3 dose selection and analysis, which will be completed soon. We have completed three international and U.S. medical advisory boards to gather input on the current and future needs of the PNH community and to understand how best to position Zaltzenibar for success against competitors. These PNH experts are working closely with us to ensure that our study protocols are designed to demonstrate Zeltanabart's potential. We anticipate having broad and geographically diverse site participation that will support both post-approval adoption and utilization.

David: We now have the needed data to finalize our phase III dose selection and analyses.

David: Will be completed soon.

Gregory Demopulos: Looking ahead to our PNH phase three program, we remain on track to initiate both our naive patient and switchover phase three trials later this year. All required activities have either been completed or are progressing as planned. We have completed three international and U.S. medical advisory boards to gather input on the current and future needs of the PNH community and to understand how best to position Zaltenabart for success against competitors. Physician advisors and focus group patients have uniformly responded positively to the unique properties of both Zaltenabart and its mass-three target, as well as to our clinical data, and they expect that Zaltenabart, when approved, will see significant uptake.

David: Looking ahead to our PSNH phase three program, we remain on track to initiate both our naive patient and switchover phase III trials later this year.

David: All required activities have either been completed or are progressing as planned.

Speaker Change: We have completed three international and U S Medical advisory boards together input on the current and future needs of the <unk> community and to understand how best to physicians all kind of bar for success against competitors.

David: Physician advisors and focus group patients have a unit formally responded positively to the unique properties of both <unk> and it's masked III target as well as to our clinical data and they expect that Santana Bard when approved.

David: We'll see significant uptick.

Gregory Demopulos: These PNH experts are working closely with us to ensure that our study protocols are designed to demonstrate Zaltenabart's potential and to help us prepare for efficient study execution. Our clinical operations team has already begun site identification and has been developing strong relationships with investigators, which should serve to speed enrollment. We anticipate having broad and geographically diverse site participation that will support both post-approval adoption and utilization. All external vendors have already been identified and awarded, and on the manufacturing front, all held Tenabart needed for our phase-free program has already been manufactured and earmarked for the clinical trials.

David: These PNA experts are working closely with us to ensure that our study protocols are designed to demonstrate <unk> potential.

David: And to help us prepare for efficient study execution.

Speaker Change: Our clinical operations team has already begun site identification and has been developing strong relationships with investigators, which should serve to speed enrollment, we anticipate having broad and geographically diverse site participation.

David: That will support both post approval adoption and utilization.

David: All external vendors have already been identified and awarded and on the manufacturing front, all help kind of art needed for our phase III program has already been manufactured and earmarked for the clinical trials.

Gregory Demopulos: With respect to our Silicon Tenabart regulatory efforts, we have prepared our briefing materials to confirm FDA and European regulatory alignment with our clinical plan and phase-free trial designs. Following our meeting with the FDA earlier this year, we incorporated all FDA feedback. We look forward to our upcoming pre-phase-free meetings with both US and European regulators, which have already been scheduled or requested.

David: With respect to our <unk>.

David: So all 10 of our regulatory efforts, we have prepared our briefing materials to confirm FDA and European regulatory alignment with our clinical plan and phase III trial designs.

David: Following our meeting with FDA earlier this year, we incorporated all FDA feedback and.

Gregory Demopulos: And we look forward to our upcoming pre-phase three meetings with both U.S. and European regulators, which have already been scheduled or requested. Turning now to Xaltenobart in C3 glomerulopathy, or C3G, our Phase 2 study is enrolling. The Phase III program in C3G is planned to initiate in the first quarter of 2025.

David: And we look forward to our upcoming pre phase III meetings with both U S and European regulators, which have already been scheduled or requested.

Gregory Demopulos: Turning now to Zaltenabart in C-3, Glimarial Optathy or C-3G, our Phase-2 study is enrolling. We look forward to sharing data from this study later this year or early next. A phase-3 program in C-3G is planned to initiate in the first quarter of 2025. Finally, while our current primary objective is to initiate our Zaltenabart PNH phase-3 trials quickly and to drive them to successful completion, we remain acutely focused on the wide applicability of mass-free and alternative pathway inhibition. As previously discussed, competitors with other agents targeting the alternative pathway have substantially de-risked of four Zaltenabart in array of indications beyond PNH.

David: Turning now to <unk> and <unk>, our phase II study is enrolling.

David: We look forward to sharing data from this study later this year or early next.

David: But phase III program in Phase III <unk> is planned to initiate in the first quarter of 2025.

David: Finally, while our current primary objective is to initiate our <unk> phase III trials quickly and to drive them to successful completion.

David: We remain acutely focused on the wide applicability of mastery on alternative pathway inhibition as previously discussed competitors with other agents targeting the alternative pathway have substantially de risked a four zol counterpart.

David: An array of indications beyond <unk>.

Gregory Demopulos: These include hygiene, apropathy, C-3, Glimarial Optathy, and age-related macular degeneration. All of these and others Zaltenabart could provide significant patient benefits over currently available treatments, specifically better safety. More consistent efficacy and superior dosing convenience and compliance.

David: These include Iga Nephropathy C. Three preliminary allopathy in age related macular degeneration, all of these and others.

David: So <unk> could provide significant patient benefits over currently available treatments, specifically better safety more consistent efficacy.

David: And superior dosing convenience and compliance.

Gregory Demopulos: I'll now turn back to our lectin pathway franchise and update you on OMS 1029, our next generation long-acting inhibitor of mask 2. We've now successfully completed both the single and multiple ascending dose Phase-1 studies of OMS 1029. The results support once quarterly dosing administered either subcutaneously or intravenously. OMS 1029 remains well tolerated, with no safety concerns identified. As previously disclosed, we're evaluating several chronic large value indications for potential development of OMS 1029. One of these being neovascular age-related macular degeneration, also known as WebAMD. in a preclinical murin model of what A&D mask 2 inhibition showed good efficacy.

Speaker Change: I'll now turn back to our lectin pathway franchise and update you on <unk> 10, 29, our next generation long acting inhibitor of mass too.

Gregory Demopulos: We've now successfully completed both the single and multiple ascending dose phase one studies of OMS 1029, and the results support once-quarterly dosing administered either subcutaneously or intravenously. OMS 1029 remains well tolerated with no safety concerns identified. We are now running a primate study comparing OMS 1029 to ILEA, which by recent report, holds the major revenue share in AMD. As discussed on our last call, all currently approved treatments for wet AMD work by inhibiting MAF2 in the liver. By contrast, because MAF2 is produced only in the liver, MAF2 inhibition throughout the body is achieved through systemic administration by any route of administration, whether that be intravenously, subcutaneously, or orally.

Speaker Change: We've now successfully completed both the single and multiple ascending dose phase one studies of RMS $10 29.

Speaker Change: The results support once quarterly dosing administered either subcutaneously or intravenously.

Speaker Change: <unk> 10, 29 remains well tolerated.

Speaker Change: With no safety concerns identified.

Speaker Change: As previously disclosed we are evaluating several chronic large value indications for potential development of <unk> 10 to 29.

Speaker Change: One of these being Neovascular age related macular degeneration also known as wet AMD.

Speaker Change: In a preclinical murine model of wet AMD <unk> inhibition showed good efficacy.

Gregory Demopulos: We are now running a primate study comparing OMS 1029 to ILEA, which by recent report holds the major revenue share in AMD. We look forward to receiving those data later this quarter. As discussed on our last call, I'll currently approve treatments for what A&D, ILEA, Lucentis; they all require frequent intra-vitreal injections, meaning injections directly into the posterior chamber of the eye. By contrast, because mask 2 is produced only in the liver, mask 2 inhibition throughout the body is achieved through systemic administration by any route of administration, whether that be intravenously, subcutaneously, or orally. What AMD is a very large market, and our work-to-date indicates that an effective therapeutic that does not require patients to receive painful injections in their eyes would be regarded by both patients and their physicians as a highly attractive alternative.

Speaker Change: We are now running a primate study comparing <unk> <unk> 29 to Eylea.

Speaker Change: Which by recent report holds the major revenue share in AMD.

Speaker Change: We look forward to receiving those data.

Speaker Change: Later this quarter.

Speaker Change: As discussed on our last call. All currently approved treatments for wet AMD.

Speaker Change: Bit Eylea lucentis.

Speaker Change: They all require frequent intravenous <unk> injections, meaning injections directly into the post terrier chamber of the eye by.

Speaker Change: By contrast, because massive too is produced only in the liver.

Speaker Change: <unk> two inhibition throughout the body is achieved through systemic administration by any route of administration, whether that'd be intravenously or subcutaneously or orally.

Speaker Change: Wet AMD is a very large market and our work to date indicates that an effective therapeutic that does not require patients to receive painful injections in their eyes would be regarded by both patients and their physicians.

Speaker Change: As a highly attractive alternative.

Gregory Demopulos: As detailed in earlier earnings calls and during our annual shareholder meeting last June, we continue our work with our SOPLIMAB and mask 2 inhibition in both severe acute and long COVID or past, as well as an acute respiratory distress or ARDS, including H1N1 and in the recently concerning H5N1. In addition to the wide therapeutic potential of mask 2 inhibition, we're also developing a diagnostic approach for these broad indications. Adoption and utilization of a diagnostic for mask 2 and lectin pathway hyperactivation would not only help physicians and their patients in early diagnosis, but would also drive adoption and utilization of our SOPLIMAB and other members of our mask 2 inhibitor therapeutic franchise across these diseases.

Speaker Change: As detailed in earlier earnings calls and during our annual shareholder meeting last June we continue our work with <unk> two inhibition in both severe acute and long COVID-19 or past.

Speaker Change: As well as an acute respiratory distress array rds, including H one N. One.

Speaker Change: And the recently.

Speaker Change: Concerning H five N one.

Gregory Demopulos: In addition to the wide therapeutic potential of MASK2 inhibition, we're also developing a diagnostic approach for these broad indications. In addition to our MASK-2 and MASK-3 antibodies, Narsopilamab, Zoltenibart, and OMS-1029, our growing complement franchise includes small molecule orally available MASK-2 and MASK-3 inhibitor programs. Both these programs are progressing rapidly, with lessons learned from our MASK-2 small molecule program being applied to and leveraged for advancing the development of our MASK-3 orally administered agents. We anticipate receiving results later this year from a preclinical toxicology study of primates exposed concurrently to cocaine and OMS 527.

Speaker Change: In addition to the wide therapeutic potential of <unk> two inhibition. We're also developing a diagnostic approach for these broad indications.

Speaker Change: Adoption and utilization of a diagnostic for masks, two and the lectin pathway hyper activation.

Speaker Change: It would not only help physicians and their patients and early diagnosis.

Speaker Change: But what also drive adoption and utilization of our <unk> and other members of our mast two inhibitor therapeutic franchise across these diseases.

Gregory Demopulos: As they become available, we'll share further important updates on our efforts on this front.

Speaker Change: As they become available we will share further important updates on our efforts on this front.

Gregory Demopulos: In addition to our mask 2 and mask 3 antibodies in our SOPLIMAB, and SOPLIMAB and SOPLIMAB are growing complement franchise includes small molecule orally available mask 2 and mask 3 inhibitor programs. Both these programs are progressing rapidly, with lessons learned from our mask 2 small molecule program being applied to and levered for advancing development of our mask 3 orally administered agents.

Speaker Change: In addition to our masks two in mass <unk> antibodies in our supplemental so I'll kind of bar <unk> $10 29.

Speaker Change: Our growing complement franchise includes small molecule orally available masked two and masked three inhibitor programs. Both these programs are progressing rapidly with lessons learned from our mast two small molecule program being applied to and Levered four <unk>.

Speaker Change: Advancing development of our mass I'm sorry.

Speaker Change: Orally administered agents.

Gregory Demopulos: Let's turn now to OMS 527, our PD 7 inhibitor program aimed at treating addiction, compulsions, and movement disorder. As previously disclosed, the National Institute on Drug Abuse, or NIDA, requested that we shift our focus for OMS 527 from nicotine addiction to the unmet and urgent need for a treatment for cocaine use disorder. Our program is funded by NIDA through a $6.7 million grant. We anticipate receiving results later this year from a pre-clinical toxicology study of primates exposed concurrently to cocaine and OMS 527. Assuming positive results in the toxicology study together with NIDA, we plan to initiate next year a randomized double-blind inpatient clinical trial evaluating OMS 527 treatment in individuals with cocaine use disorder.

Speaker Change: Let's turn now to all of them as five to seven or <unk> inhibitor program aimed at treating addiction and compulsions in movement disorders.

Speaker Change: As previously disclosed the National Institute on drug abuse, or <unk> requested that we shift our focus for all of them as five to seven from nicotine addiction to the unmet an urgent need for a treatment for cocaine use disorder.

Speaker Change: Our program is funded by <unk> through a $6 $7 million grant.

Speaker Change: We anticipate receiving results later this year from a preclinical toxicology study of primates exposed with concurrently to cocaine and <unk> five through seven.

Speaker Change: Assuming positive results from the toxicology study together with <unk>, we plan to initiate next year, a randomized double blind in patient clinical trial evaluating all of them as five to seven treatment in individuals with cocaine use disorder.

Gregory Demopulos: As also discussed in earlier calls, we're exploring the potential use of OMS 527 in movement disorders, specifically levodopa-induced dyskinesia or LID. This is a major problem in patients with Parkinson's disease and is caused by levodopa, the most common therapeutic use in Parkinson's disease. There is no good treatment for LID, and as a result, LID certainly represents a large and essentially untapped commercial market for an effective and safe therapeutic.

Gregory Demopulos: As discussed in earlier calls, we're exploring the potential use of OMS-527 in movement disorders, specifically levofopa-induced dyskinesias (LID), namely our signal signaling driven immunomodulators, and our antigen driven immunomodulators that function not only as therapeutics, but also as cancer vaccines. Each of our IO platforms represent novel approaches to cancer treatment designed to target both cell surface and intracellular cancer targets for broad Create immune memory against future relapse and eliminate the need for costly and time-intensive cellular modification or engineering.

Speaker Change: As also discussed in earlier calls, we're exploring the potential use them over five to seven in movement disorders specifically.

Speaker Change: Levodopa induced dyskinesia or L. I D.

Speaker Change: This is a major problem in patients with Parkinson's disease and has caused.

Speaker Change: By levodopa, the most common therapeutic use in Parkinson's disease.

Speaker Change: There is no good treatment for <unk> and as a result <unk>.

Speaker Change: Certainly represents a large and essentially untapped commercial market for an effective and safe therapeutic.

Gregory Demopulos: We'll wrap up our program discussion with our family of biologic and cellular immuno-oncology platforms. Namely, our signaling-driven immunomodulators are antigen-driven immunomodulators that function not only as therapeutics, but also as cancer vaccines. Our oncotoxins and our adoptive T-cell therapy that requires no engineering and could supersede CAR-T, able to treat both liquid and solid tumors and amenable to multiple repetitive dosing. All these platforms are advancing quickly. Around each, we continue generating really a steady stream of compelling and exciting in vivo data, expanding and strengthening their respective intellectual property positions. Each of our IO platforms represent novel approaches to cancer treatment designed to one target both cell surface and intracellular cancer targets for broad cancer applicability to increase CD4, CD8, and memory T-cell levels to attack cancer cells effectively and sustainably.

Speaker Change: Yeah.

Speaker Change: We'll wrap up our program discussion with our family of biologic and cellular immuno oncology platforms.

Speaker Change: Namely our signal signaling driven immuno modulators or antigen, driven immuno modulators that function not only as therapeutics, but also as cancer vaccines.

Speaker Change: Our <unk>.

Speaker Change: And our adoptive T cell therapy that requires no engineering and good supersede car T.

Speaker Change: April to treat both liquid and solid tumors.

Speaker Change: The amenable to multiply repetitive dosing.

Speaker Change: All of these platforms are advancing quickly.

Speaker Change: Around each we continue generating.

Speaker Change: Really a steady stream of compelling and exciting in vivo data.

Speaker Change: Spanning and strengthening their respective intellectual property positions.

Speaker Change: Each of our Io platforms represent novel approaches to cancer treatment design.

Speaker Change: Designed to one.

Speaker Change: Target, both self surface and intracellular cancer targets for broad cancer applicability.

Speaker Change: To increase C. D. Four C D E and memory T cell levels to attack cancer cells effectively and sustainably.

Gregory Demopulos: 3. Create immune memory against future relapse and 4. Eliminate the need for costly and time intensive cellular modification for engineering. here. Given the growing volume and breadth of encouraging data, we are working diligently to include them in our patent applications. Once all initial patent applications have been fun, we will share data through one or more public avenues.

Speaker Change: Three.

Speaker Change: Create immune memory against future relapse, and four eliminate the need for costly and time intensive cellular modification or engineering.

Gregory Demopulos: Given the growing volume and breadth of encouraging data, we are working diligently to include them in our patent application. Once all initial patent applications have been filed, we will share the data through one or more public avenues. I'll now turn the call over to David Borges, our Chief Accounting Officer, to go through a more detailed discussion of our financial results. David? Thanks, Greg.

Speaker Change: Given the growing volume and breadth of encouraging data we are working diligently to include them in our patent applications.

Speaker Change: Once all initial patent applications have been filed.

Speaker Change: We will share data through one or more public avenues.

David Borges: I'll now turn the call over to David Borges, our Chief Accounting Officer, to go through a more detailed discussion on our financial results.

David Borges: Our net loss for the second quarter of 2024 was $56 million, or $0.97 per share, compared to a net loss of $37.2 million, or $0.63 per share, in the first quarter of 2024. Recall that our accounting policy is to expense all manufacturing costs related to drug candidates until a regulatory approval is reasonably assured in either the U.S. or the European Union, for term loan related transaction costs in the second quarter. Costs and expenditures, of this significance.

Speaker Change: I'll now turn the call over to David <unk>, Our Chief Accounting Officer to go through a more detailed discussion of our financial results David Thanks, Greg.

David Borges: David, thanks, Greg. Our net loss for the second quarter of 2024 was $56 million for 97 cents per share, compared to a net loss of $37.2 million for 63 cents per share in the first quarter of 2024. In Q2, we incurred $17.6 million of R&D expense related to the manufacturer of their supplement of drug substance Lodz that commenced in October 2023 and were delivered in the second quarter of this year. Recall that our accounting policy is to expense all manufacturing costs related to drug candidates until regulatory approval is reasonably assured in either the U.S. or the European Union.

David <unk>: Loss for the second quarter of 2024 was $56 million or <unk> 97 per share compared to a net loss of $37 2 million or 63 per share in the first quarter of 2024.

Speaker Change: In Q2, we incurred $17 $6 billion of.

Speaker Change: R&D expense related to the manufacture of <unk> drug substance lots that commenced in October 2023, and were delivered in the second quarter of this year.

Speaker Change: Call that our accounting policy is to expense all manufacturing costs related to drug candidates until a regulatory approval is reasonably assured in either the U S or the European Union.

David Borges: We also incurred $21.2 million in discounted term loan-related debt repurchase and $1.9 million for term loan-related transaction costs in the second quarter.

Speaker Change: We also incurred $21 $2 million in discounted term loan related debt repurchase and $1 $9 million.

Speaker Change: For term loan related transaction costs in the second quarter.

David Borges: Costs and expenditures of the significance there are some of that manufacturing about the discounted term loan-related debt repurchase and a term loan-related transaction cost representing a total of $40.7 million are not expected in a foreseeable future. As of June 30, 2024, we had $158.9 million of cash and investments on hand, a decrease of $71.4 million from March 31, 2024.

Speaker Change: Costs and expenditures.

Speaker Change: The significance.

David Borges: They're an ensemble manufacturing about the discounted term loan related debt repurchase and a term loan related transaction cost representing a total of $40.7 million are not expected in the foreseeable future. As of June 30, 2024, we had $158.9 million of cash and investments on hand, a decrease of $71.4 million from March 31, 2024. One, we paid $10.7 million in the second quarter and $6.9 million in the first quarter related to six lots of Narsopimab drug substance which were commenced in October 2023 and released in the current quarter. The increase was driven by Narsopimab drug substance manufacturing, Deltenoparc Clinical Research, and the discounted debt repurchase transaction cost, all partially offset by lower expenditures on the IGANT clinical trial as we closed down that

Speaker Change: Some of that manufacturing amounts to discounted term loan related debt repurchase and a term loan related transaction cost representing a total of $47 million are not expected in the foreseeable future.

Speaker Change: As of June 32024, we had one $158 $9 million of cash and investments on hand, a decrease of $71 4 million from March 31 2024.

David Borges: Two second quarter transactions significantly affected our Q2 ending cash balance. One, we paid $10.7 million in the second quarter and $6.9 million in the first quarter related to six lots of their supplement drug substance, which were commenced in October 2023 and released in the current quarter. And two, we paid $21.2 million to hybrids and Ethereum in connection with the discounted debt repurchase in June 2024. Costs and expenses from continuing operations for the second quarter were $59.2 million, which was an increase of $20.1 million from the first quarter of this year. The increase was driven by nurse op-a-map drug substance manufacturing, cell tenipart clinical research, and the discounted debt repurchase transaction cost.

Speaker Change: Two second quarter transactions significantly affected our Q2 ending cash balance.

Speaker Change: We paid $10 $7 million in the second quarter and $6 9 million in the first quarter related to six lots of in our supplement drug substance, which were commenced in October 2023, and released in the current quarter.

Speaker Change: And two we paid $21 $2 million to hybrids in imperium in connection with the discounted debt repurchase in June 2024.

Speaker Change: Costs and expenses from continuing operations for the second quarter or <unk> $59 $2 million, which was an increase of $20 1 million for the first quarter of this year.

Speaker Change: Kris was driven by in our supplement drug substance manufacturing all 10 of our clinical research and the discounted debt repurchase transaction costs, all partially offset by lower expenditures on AI again clinical trial as we close down that trials.

David Borges: All partially offset by lower expenditures on the Agant clinical trial as we close down that trial. Interest expense for the second quarter was $9.2 million, which is $1 million higher than the first quarter of this year due to increased interest expense associated with the DRI transaction that was finalized in February 2024. The primary drivers of interest expense are the 26 notes and the DRI, Middria, Royalty application. Interest and other income for the second quarter was $3.2 million, which was slightly lower compared to interest and other income from the first quarter of this year due to lower cash balances to invest.

David Borges: Interest expense for the second quarter was $9.2 million, which is $1 million higher than the first quarter of this year due to increased interest expense associated with the DRI transaction that was finalized in February 2024. The primary drivers of interest expense are the 2026 notes and the DRI mid-royalty obligation. Interest and other income for the second quarter was $3.2 million, which was slightly lower compared to interest and other income from the first quarter of this year due to lower cash balances to invest. Income from discontinued operations for the second quarter of this year was $9.1 million and included two primary components.

Speaker Change: Interest expense for the second quarter was $9 2 million, which is $1 million higher than the first quarter of this year due to increased interest expense associated with the <unk> transaction that was finalized in February 2024.

Speaker Change: The primary drivers of interest expense are the <unk> 'twenty six notes and the DRA imagery at royalty obligation.

Speaker Change: Interest and other income for the second quarter was $3 $2 million, which was slightly lower compared to interest and other income from the first quarter of this year due to lower cash balances to invest.

David Borges: Income from discontinued operations in the second quarter of this year was $9.1 million, and includes two primary components. One, $4.3 million of interest earned on the Amidria contract royalty asset; two, $4.3 million of read measurement adjustments to the Amidria contract royalty asset.

Speaker Change: Income from discontinued operations in the second quarter of this year was $9 1 million and includes two primary components.

Speaker Change: $4 3 million of interest earned on the imagery at contract royalty asset.

Speaker Change: $4 3 million re measurement adjustments to the imagery that contract royalty asset.

David Borges: As we have previously made clear, royalty's earned are recorded as a reduction in the Amidria contract royalty asset on our balance sheet and not in our income statement. The Middria Royalty's for the second quarter were $10.9 million on Amidria net sales of $36.4 million. This is compared to royalty's of $9.4 million on first quarter net sales of $31.2 million, a $5.2 million increase in net sales of the first quarter of 2024. The increase in net sales from the first quarter is consistent with historical Amidria net sales trends.

David Borges: As we have previously made clear, royalties earned are recorded as a reduction in the invigorated contract royalty asset on our balance sheet and not in our income statement. As we discussed in last quarter's earnings call, in February 2024, we entered into an amended agreement with DRI by which they acquired the right to receive all U.S. and Middle-Earth royalties payable by Rainer through December 31, 2031. We continue to hold all royalty rights to the ex-U.S. sales of Emedrea, and after December 31, 2031, all U.S. royalty payments will also accrue to Omeros.

Speaker Change: As we have previously made clear royalties earned are recorded as a reduction in the imagery of contract royalty asset on our balance sheet and not hit our income statement.

Speaker Change: Imagery of royalties for the second quarter were $10 $9 million on Omidria net sales of $36 4 million.

Speaker Change: This is compared to royalties of $9 $4 million on first quarter net sales of $31 2 million or $5 2 million increase in net sales over the first quarter of 2024.

Speaker Change: The increase in net sales from the first quarter is consistent with historical Omidria net sales trends.

David Borges: As we discussed in last quarter's earnings call in February 2024, we entered into an amended agreement with DRI, by which they acquired the right to receive all US Amidria royalties payable by Rainer through December 31, 2031. We continue to hold all Royalty rides to ex-US sales of the Amidria, and after December 31, 2031, all US royalty payments also accrued to Amarose. In addition, we have the opportunity to earn two sales contingent milestones, each up to $27.5 million, with payment dates in January 26, in January 20, 28.

Speaker Change: As we discussed in last quarter's earnings call in February 2024.

Speaker Change: We entered into an amended agreement with <unk> by which they acquired the right to receive all U S and mitigated royalties payable rate payable by Rainer through December 31, 2031.

Speaker Change: We continue to hold all royalty rights to ex U S sales of Omidria and after December 31 2031.

Speaker Change: Our U S royalty payments also accrued tomorrows.

Speaker Change: In addition, we have the opportunity to earn two sales contingent milestones each up to $27 $5 million with payment dates in January 2006 in January 2028.

David Borges: As Greg mentioned, in June, we substantially strengthened our balance sheet to our debt repurchase and exchange transaction, whereby we repurchased, retired a portion of our 2026 notes for cash in a new-term loan. The total principal amount of the 2026 notes exchanged was $118.1 million in exchange for total consideration of $88.3 million, consisting of a cash payment of $21.2 million and a new secured loan of $60.1 million, extending maturity on that portion of our debt out to June of 2028. In addition, we have a $25 million delayed draw in term loan available to be drawn on or prior to June 3, 2025, contingent on regulatory approval of their SOFMAF and TA-TMA.

Speaker Change: As Greg mentioned in June we substantially strengthened our balance sheet to our debt repurchase and exchange transaction.

Greg: Whereby we repurchased and retired a portion of our 2026 notes for cash and a new term loan.

David Borges: In addition, we have the opportunity to earn two sales contingent milestones, each up to $27.5 million with payment dates in January 26 and January 2028. The total principal amount of the 2026 notes exchanged was $118.1 million in exchange for total consideration of $88.3 million, consisting of a cash payment of $21.2 million and a new secured loan of $67.1 million, extending maturity on that portion of our debt out to June 2028.

Speaker Change: Total principal amount of the 'twenty 'twenty six notes exchanged was $118 $1 million in exchange for total consideration of $88 3 million consisting of a cash payment of $21 2 million and a new secured loan of $60 $167 1 million.

Speaker Change: Extending maturity on that portion of our debt out to June of 2028 and.

David Borges: In addition, we have a $25 million delay-draw term loan available to be drawn on or prior to June 3, 2025, contingent on regulatory approval of NRSAPA MAP and TATMA. The term loan is secured by substantially all our assets and carries an interest rate based on the current adjusted secured overnight financing rate, or SOFR, plus 875 basis points. The combined rate at June 30, 2024 was 14.2%.

Speaker Change: In addition, we have a $25 million delayed draw term loan available to be drawn on or prior to June 3rd 2025 contingent on regulatory approval of their supplements and Ta TMA.

David Borges: The term loan is secured by substantially all our assets and carries an interest rate based on the current adjusted, secured overnight financing rate, or SOFER, plus $875. The combined rate at June 30, 2024, was 14.2%. The term loan agreement includes a covenant requiring us to maintain unrestricted cash and cash equivalence of at least 25 million. The $88.3 million of new term loan in total cash spent to repurchase debt represented at discount of approximately 25% or $29.8 million off a par. This transaction brings our remaining total about standing 2026 notes down by 55% from $216 million to a much more manageable $98 million.

Speaker Change: The term loan is secured by substantially all of our assets and carries an interest rate based on our current adjusted secured overnight financing rates are suffer plus 875 basis points.

Speaker Change: The combined rate at June 32024 was 14, 2%. The term loan agreement includes a covenant requiring us to maintain unrestricted cash and cash equivalents of at least $25 million.

David Borges: The term loan agreement includes a covenant requiring us to maintain unrestricted cash and cash equivalents of at least $25 million. The $88.3 million of new term loan and total cash spent to repurchase debt represent a discount of approximately 25%, or $29.8 million off of PAR. This transaction brings our remaining total of outstanding 2026 notes down by 55% from $216 million to a much more manageable $98 million. The $29.8 million discount from PAR has been recorded as a premium, i.e.

Speaker Change: The $88 3 million.

Speaker Change: Of new term loan and total cash spent to repurchase debt represented a discount of approximately 25% or $29 8 million of par.

Speaker Change: This transaction brings our remaining total of outstanding 2026 notes down by 55%.

Speaker Change: From $216 million, so much more manageable $98 million.

David Borges: The $29.8 million discount from par has been recorded as a premium, i.e. an increase to the term loan being recognized as a gain of early extinguishment of debt. The $29.8 million premium will be amortized against interest expense over the term of the loan, which results in an effective interest rate of 1.6% for financial statement purposes. The amount of interest expense expected to be recognized in a third quarter related to this new term loan is approximately $400,000.

David Borges: an increase to the term loan being recognized as a gain on the early extinguishment of debt. The $29.8 million premium will be amortized against interest expense over the term of the loan, which results in an effective interest rate of 1.6% for financial statement purposes. Now let's look at our expected third quarter results, which occurred in connection with the discounted debt repurchase. And finally, income from discontinued operations should be in the $7 to $8 million range.

Speaker Change: The $29 $8 million discounts from par has been recorded as a premium I E. An increase to the term loan being recognized as a gain on early extinguishment of debt at.

Speaker Change: The $29 8 million premium will be amortized against interest expense over the term of the loan which results in an effective interest rate of one 6% for financial statement purposes.

Speaker Change: The amount of interest expense expected to be recognized in the third quarter related to this new term loan is approximately $400000.

David Borges: Now let's look at our expected third quarter results. We expect overall operating cost from continuing operations in a third quarter to decrease by approximately $20 million. The decrease is primarily due to the significant expenses reported in the second quarter related to the receipt of our supplement and drug substance, the cash paid to repurchase our 26 notes, and transaction cost incurred in connection with the discounted debt repurchase. Interest income for the third quarter should be nearly $2.5 million, and interest expense should be approximately $8.2 million. A decrease of $1 million from the second quarter due to a decrease in our outstanding debt and the lower financial statement interest rate on a term loan.

Speaker Change: Now, let's look at our expected third quarter results.

Speaker Change: We expect overall operating costs from continuing operations in the third quarter to decrease by approximately $20 million. The decrease is primarily due to the significant expenses reported in the second quarter related to the receipt of in our supplement drug substance the cash paid to repurchase our 'twenty six notes.

Speaker Change: And transaction costs incurred.

Speaker Change: In connection with the discounted debt repurchase.

Speaker Change: Interest income for the third quarter should be nearly $2 5 million and interest expense should be approximately $8 $2 million a decrease of $1 million from the second quarter due to a decrease in our outstanding debt and a lower financial statement interest rate on the term loan.

David Borges: And finally, income from discontinued operations should be in the $7 to $8 million range.

Speaker Change: And finally income from discontinued operations should be in the $7 million to $8 million range.

Gregory Demopulos: With that, turn the call back over to Greg.

Speaker Change: With that I'll turn the call back over to Greg.

Gregory Demopulos: Thanks, David.

Greg: Thanks, David.

Unknown Executive: Operator, let's please open the call to question. Thank you very much. To ask a question, you will need to press star 11 on your telephone and wait to be announced. To withdraw your question, please press star 11 again.

Greg: Operator, let's please open the call to questions.

Speaker Change: Thank you very much.

Operator: To ask a question, you will need to press star 11 on your telephone and wait to be announced. To withdraw your question, please press star 11 again. Please stand by while we compile the Q&A room. Our first question today comes from Steve Brozak with WBB. Your line is open.

Speaker Change: Can you ask a question you will need to press star one one on your telephone and wait to be.

Speaker Change: To withdraw your question please.

Speaker Change: Sure.

Unknown Executive: Please stand by while we compile the Q&A roster.

Speaker Change: Okay.

Speaker Change: Please standby, while we compile the Q&A roster.

Stephen Brozak: Our first question today comes from Steve Rosak with WBB. Your line is open.

Speaker Change: Our first question today comes from Steve Brozak with <unk>. Your line is open.

Stephen Brozak: Hey, good afternoon, and thanks for taking the questions. I actually have two. The first one is on the quarter in terms of the expenses. Can you give us any modeling or any idea as to how this expense that we modeled in basically would factor into the future? And I've got a follow-up after that, please.

Stephen Brozak: Hey, good afternoon and thanks for taking the question questions. I actually have two. The first one is on the quarter in terms of the expenses. Can you give us any modeling or any ideas to how this expense that we modeled in basically would factor into the future? And I've got to follow up after that, please. Sure, I think I hope we were pretty clear, Steve, that those expenses that were the large expenses and charges and costs incurred in the second quarter were those that we don't expect to be repeated. There was a large manufacturing cost; there was a repurchase of the term loan related debt, 21.2 million, where again that was at 75% of par. So all of that got retired, and then there were the term loan related transaction costs.

Steve Brozak: Hey, good afternoon, and thanks for taking the question.

Speaker Change: Question.

Speaker Change: Actually I have two.

Speaker Change: The first one is.

Speaker Change: The quarter in terms of the expenses.

Speaker Change: Can you give us any modeling or any idea as to how this expense that we modeled in basically wood.

Speaker Change: Would factor into the future and I've got a follow up after that please.

Gregory Demopulos: Sure. I think, I hope we were pretty clear, Steve, that those expenses that were the large expenses and charges and costs incurred in the second quarter were those that we don't expect to be repeated. There was a large manufacturing cost. There was a repurchase of the term loan related debt, $21.2 million, where again that was at 75% of par, related transaction costs. So I think that I'm not sure that I answered your question, but if not, let me know, and we can...

Speaker Change: Sure.

Speaker Change: I hope we were pretty clear Steve.

Speaker Change: Those expenses that were.

Speaker Change: The large expenses.

Speaker Change: <unk> charges and costs incurred in the second quarter.

Speaker Change: Were those that we don't expect.

Speaker Change: To be repeated.

Speaker Change: There was a large manufacturing cost.

Speaker Change: Yeah, there was a repurchase of the term loan.

Speaker Change: Related debt.

Speaker Change: 21 2 million were.

Speaker Change: Again that was at 75% of par.

Speaker Change: So all of that.

Speaker Change: Retire.

Speaker Change: And then there were the.

Speaker Change: Term loan.

Speaker Change: Related transaction costs.

Stephen Brozak: So I think that I'm not sure that answered your question, but if not, let me know and we can, we can. Yeah, no, that covered it exactly.

Speaker Change: So I think that I'm not sure that answered your question, but if not.

Speaker Change: Let me know and we can.

Speaker Change: No.

Gregory Demopulos: That covered it exactly. I just wanted to understand how to think about modeling in the future. And these were just obviously one-time expenses, which actually brings me to the manufacturing side. For the purposes of the future, when you see approval, what else do you need? Now that you've got this manufacturing expense done, what else do you need to be able to go out there? And when you get approval, what else would you need to literally go into the markets? And you can be as detailed as you want on that because I'm kind of curious to see how to model that in the future.

Speaker Change: That covered exactly I just wanted to understand how does how do you see about about modeling into the future needs, which is obviously, one time expenses, which actually brings me on the manufacturing side.

Gregory Demopulos: I just wanted to understand how to see about modeling into the future, and these were just obviously one-time expenses, which actually brings me on the manufacturing side for the purposes of future. When you see approval, what else do you need now that you've got this manufacturing expense done? What else do you need to be able to go out there, and when you will get approval, what else would you need to literally go into the markets? You can be as detailed as you want on that because I'm kind of curious if you had a model out in the future, please.

Speaker Change: For the purposes of future when you see approval.

Speaker Change: What else do you need.

Speaker Change: Now that you've got this manufacturing.

Speaker Change: Expense done what else do you need to be able to go out there and.

Speaker Change: When you will get approval what else would you need to literally go into.

Speaker Change: The markets and you can be as detailed as you want on that because I'm kind of curious as to how to model that in the future. Please.

Catherine Melfi: Well, there's one rather large component that we would need, which would be FDA approval. And we're working hard to secure that. I mean, when you look at the data, we think the data are very clear. And frankly, as I said, we have a meeting scheduled with the FDA; those were part of the prepared comments. And we believe we're in very good shape with respect to the data and the case for its approval. So we just need to play this out a bit, but that's really what we need in the get Kathy to weigh in. And then I'll also ask Nadia and Andreas to comment if they have anything else to add from the commercial or clinical perspective.

Speaker Change: Well, there's one rather large component that we would need which would be FDA approval.

Speaker Change: And we're working we're working hard.

Speaker Change: To secure that I mean when you.

Speaker Change: You look at the data we think the data are very clear and.

Speaker Change: Frankly.

Speaker Change: As I said, we we have a meeting scheduled with FDA those were part of the prepared comments.

Speaker Change: And we believe.

Speaker Change: We're in very good shape with respect to the data and the case for its approval.

Speaker Change: So we just need to play this out a bit but thats really what we need in the U S. We're also pursuing as you know.

Speaker Change: EMEA approval R&R sample them out.

Speaker Change: Let me stop and get Kathy to weigh in and then I'll also ask.

Kathy: Not yet.

Kathy: Andreas to comment if they have anything else to add from the commercial or clinical perspective, but Kathy do you want to you want to take the yes.

Nadia Dac: But Kathy, do you want to take that? Yeah, sure. And I think also part of the question was, when we get approval, what next? And we are well positioned, and we're anticipating, and we're preparing for success. And we're set up in terms of our packaging operations and that sort of thing from the regulatory perspective. So we are definitely planning for success in terms of what we have lined up as you said, Steve, when we get approval, but I'll comment on it. commercial and clinical piece weigh-in as well. Now I'll jump in and we are planning for success and have been and so we have everything laid out and down to the last month and gated behind key decisions all the way down to brand name as well and making sure all of that is ready to go. So that's kind of the good news of the July is that we could plan for this but there are multiple things that we still need and everything is being planned for and progressed.

Kathy: Yes, sure and I think also part of the question.

Kathy: When we get a protocol.

Speaker Change: And we are well positioned and we're anticipating and we're preparing for success.

Speaker Change: Your setup in terms of our.

Kathy: Packaging operations and that sort of thing from a regulatory perspective. So we are definitely planning for success in terms of what we have lined up.

Kathy: As you said, Steve when we get approval, but I'll, let <unk>.

Steve Brozak: The commercial and clinical pizza weigh in as well.

Steve Brozak: Yes ill jump in and we are planning for success and have been and so we have everything laid out his talent to the last month's end.

Steve Brozak: And gated behind key decisions all the way down to the brand name as well and making sure all of that is ready to go. So that's kind of the good news is as I go ahead.

Steve Brozak: Is that we could plan for this but there are multiple things that we still need and everything is being planned for and progressed.

Gregory Demopulos: Well, from a clinical point of view, I think what we need after approval is patients and physicians ready to use the product, and if our expanded access program is any indication, then they're already there, they want a supplement, they're using it in their patients, especially in patients that fail currently available treatments, so we're encouraged that It can bring something to the market that is needed and will help patients, and also the international scientific community, seems to, They've issued a harmonization of the diagnostic criteria. They've identified clear high-risk and treatment criteria.

Andreas Grauer: Well, I'm from a clinical point of view. I think what we need, or after approval, is some patients and physicians ready to use the product. And if our expanded access program is any indication, then they're already there. They want to solve them up; they're using it in their patients, especially in patients that fail currently available treatments. So, we're encouraged that we actually can bring something to market that is needed and will help patients. And also, the international scientific community seems to look differently at transplant-associated TMA in the last years. They've issued a harmonization of the diagnostic criteria; they've identified clear high-risk and treatment criteria. So, to grasp on, the only thing we need is approval.

Steve Brozak: From them.

Speaker Change: Clinical point of view I think but.

Steve Brozak: We need or after approval.

Steve Brozak: Patients and physicians ready to use the product and its our expanded access program is any indication then we're already there.

Steve Brozak: They werent I saw them up they are using it in their patients, especially in patients that failed currently available treatments. So we're encouraged.

Steve Brozak: Can bring something to market.

Steve Brozak: Needed in most of our patients.

Steve Brozak: And.

Steve Brozak: Also the international scientific community seems to.

Steve Brozak: Look differently at transplant associated TMA and the lost years they've.

Steve Brozak: Issued a harmonization of state diagnostic criteria, they've identified clear high risk and treatment criteria.

Steve Brozak: So to Greg's point, the only thing we need this approval.

Steve Brozak: Thanks.

Gregory Demopulos: And thank you all of you, and we, you know, we certainly, as I think everyone has relayed in their comments, we believe we are well prepared and frankly well-deserving of having our soft lemaab approved. Patients clearly needed, patients clearly are using it, physicians using it, as Andrea said, through the expanded access program. And remember, the only thing they have available now are all off-laden therapies. And as I think we pointed out in a previous fall in the expanded access program, where we treat both adult and pediatric patients, of the 136 patients, when we did the data cut on the expanded access program, 53 of those had failed or stopped treatments with one or more other agents. And so you really have to think about that as when our soft lemaab was used in these patients, it was really catching a falling knife. And yet, despite that, about half of those patients did well and resolved their TMA. So, you know, that is that is a somewhat controlled experiment, an internal control that you see the effect of nursing.

Gregory Demopulos: And thank you, all of you. And we certainly, as I think everyone has, relayed in their comments, of having their supplemab approved patient therapies. And as I think we pointed out in a previous call in the expanded access program, where we treat both adult and pediatric patients, of the 136 patients when we did the data cut on the Expanded Access Program, 53 of those had failed or stopped.

Steve Brozak: And thanks to all of them.

Steve Brozak: We.

Steve Brozak: We certainly as I think everyone has as relayed in there in their comments.

Steve Brozak: We believe we are well prepared.

Steve Brozak: And frankly, well deserving.

Steve Brozak: Of.

Steve Brozak: Having our thoughtful amount of approved patients.

Gregory Demopulos: They need it.

Gregory Demopulos: Patients clearly are using it.

Steve Brozak: Physicians using it as Andreas said through the expanded access program and remember the only thing they have available now are all off label.

Steve Brozak: Therapies.

Steve Brozak: Yes.

Speaker Change: As I think we've pointed out in our previous call in the expanded access program.

Andreas: Where we treat both.

Gregory Demopulos: Adult and pediatric patients.

Gregory Demopulos: Of the 100 and.

Steve Brozak: 36 patients.

Steve Brozak: When we did the data cut on the expanded access program 53 of those.

Speaker Change: Had failed their stopped.

Steve Brozak: Treatment with one or more other agents.

Gregory Demopulos: And so you really have to think about that as when narsoplimab was used in these patients, it was really catching a falling knife. And yet, despite that, about half of those patients did well and resolved their TMA. So, you know, that is a somewhat controlled experiment, an internal control that you see the effect of NAR supplements.

Steve Brozak: And so you really have to think about that as when our <unk> was used in these patients.

Gregory Demopulos: It was really catching a falling knife.

Gregory Demopulos: And yet despite that about half of those patients.

Speaker Change: Uh huh.

Did well and resolve their TMA.

Gregory Demopulos: So that is that is a.

Gregory Demopulos: A somewhat.

Gregory Demopulos: Controlled experiment and internal control that you see the effect of our supplement so we are <unk>.

Gregory Demopulos: from that. So we are obviously pushing hard here, and we need to get to resolution quickly.

Unknown Executive: So we are. Oh, great. Thank you. Thank you for coming.

Speaker Change: Obviously pushing harder here.

Unknown Executive: And we need.

Unknown Executive: We need to get to resolution quickly.

Unknown Executive: Oh, great. Thank you. Thank you for the iteration on all the steps that have been covered. That's something that, frankly, I'm thrilled that you've covered those bases, and I look forward to, obviously, good news in the future. Thank you.

Stephen Brozak: Great. Thank you. Thank you for the iteration on all the steps that have been covered. That's something that, frankly, I'm thrilled that you've covered those spaces, and I look forward to obviously the good news in the future. Thank you.

Speaker Change: Oh, great. Thank you. Thank you for the duration on the on all the steps that have been public that's it.

Unknown Executive: Something that frankly im thrilled but.

Unknown Executive: Probably those spaces and I look forward to obviously the good news in the future. Thank you.

Steve: Thanks, Steve.

Speaker Change: Thank you.

Olivia Brayer: Our next question comes from Olivia Brayer with Cantor. Your line is open.

Olivia Brayer: Our next question comes from Olivia Brayer with Cantor. Your line is open.

Speaker Change: Our next question comes from Olivia Brayer with Cantor Your line is open.

Olivia Brayer: Hey, good afternoon guys, and thank you for the questions. Greg, can you tell us when that additional meeting with the FDA is expected to happen and whether there's any new information or data that they've asked for ahead of that meeting? And then I have a follow-up question on the pipeline at 906.

Olivia Brayer: Hey, good afternoon, guys. Thank you for the questions. Greg, can you tell us when that additional meeting with the FDA is expected to happen and whether there's any new information or data that they've asked for ahead of that meeting? And then I have a follow-up on the pipeline on 906.

Olivia Brayer: Hey, good afternoon guys.

Speaker Change: Thank you for the questions Greg.

Greg: When that additional meeting with the FDA is expected to happen and whether there's any new information or data that they ask for ahead of that meeting.

Speaker Change: And then I have a follow up on the pipeline.

Olivia Brayer: Yes.

Gregory Demopulos: Yeah, I'm hi, Olivia. How are you? We won't specify the date of the meeting, and the information is, as you might expect, information on our programs and responses to FDA questions. I think that's a fair representation, but again, let me see if Kathy wants to add anything specifically to that. Yeah, really, really nothing to add. I think I think you covered a great thing. Okay, understood. And then on 906, just wanted to clarify that you guys do have the monotherapy data in-house.

Greg: Yeah, Hi, Olivia how are you.

Speaker Change: We won't specify the date of the meeting.

Speaker Change: And the information.

Speaker Change: But as you might expect information on our programs and responses to FDA questions I think that that's a fair representation, but again, let me shift catheter he wants to add anything specifically to that.

Speaker Change: Really nothing to add I think I think you covered it great. Thanks.

Gregory Demopulos: Okay, understood. And then on 906, just wanted to clarify that you guys do have the monotherapy data in-house. And if so, can you give us a sense for just the level of confidence around that program and anything you can tell us at this point about the phase 3 trial designs, both for PNH and also C3D?

Speaker Change: Okay understood and then on that note six.

Gregory Demopulos: Clarify that you guys do you have the monotherapy data in house and if so can you give us a sense for just level of confidence around that program and anything you can tell us at this point on the phase two trial designs.

Steve Whitaker: And if so, can you give us a cent for just level of confidence around that program and anything you can tell us at this point on the Fe3 trial designs, both for PNH, but also C3D?

Gregory Demopulos: Peony.

Gregory Demopulos: <unk>.

Steve Whitaker: Let me hand that over to Steve Whitaker. Excuse me. First, I'll talk about the monotherapy data. Unfortunately, we can't give you any specific details on that data because, as Greg said, that's been submitted to an ASHAB Stractons embargoed until, as publishes that, which will come later in the year. The data is strong. We're feeling positive about everything. We're seeing both in that adjunct of switch study, as well as the data we've already presented in the naive study. And Greg also mentioned that we've minted that protocol to develop data to help with those selection. You're saying the question was related to how the Fe3 program is moving forward?

Gregory Demopulos: So let me hand that over to Steve would occur.

Speaker Change: First of all excuse me first I'll talk about the.

Speaker Change: Monotherapy data Unfortunately, we can't give you.

Gregory Demopulos: Any specific details on that data because as Greg said, that's been submitted to an ash abstract is embargoed until.

Speaker Change: As publishes that which will come later in the year to date are strong we're feeling positive about everything were seeing both from that.

Gregory Demopulos: <unk> switch study as well as the.

Speaker Change: The data we've already.

Gregory Demopulos: Presented in the naive study and.

Gregory Demopulos: Greg also mentioned that we amended that protocol to develop data to help with dose selection.

Speaker Change: Your second question was related to how the phase III programs.

Steve Whitaker: I think one was also how are we viewing the program generally? How do we, what's our site? So they're excited about the program; the data coming in strongly, good differentiators, competitors out there, both in the target, as well as the drug. And having tremendous response, both the opinion leaders, as well as potential clinical trials sites who were talking to and out. The responses have been uniformly positive, and the advisory boards that we've conducted today. I'm just a little anecdotal example at the European Humanology Association. We took clinical operations people with us to get ready for the Fe3 trials.

Speaker Change: Moving forward well I think one was also.

Speaker Change: Or are we viewing the program generally how do we win.

Gregory Demopulos: Thanks.

Speaker Change: Very excited about the program the data are coming in.

Speaker Change: Strongly good differentiators.

Speaker Change: Competitors out there both in the target as well as the drug and having tremendous response from both key opinion leaders as well as potential clinical trial sites, who we're talking to now.

Speaker Change: The response has been uniformly positive and the advisory boards that we've conducted to date.

Gregory Demopulos: <unk>.

Speaker Change: Just a little anecdotal example, European Hematology Association, we took clinical operations people with us to get ready for the phase III trials not only do they have a lot of meetings set up with <unk>.

Steve Whitaker: Not only did they have a lot of meetings set up with investigative sites who were interested, but people we hadn't contacted were coming up to our booth and asking to talk to them about potentially getting their patients into the clinical trials. So there's a lot of excitement out there around the program, which is keeping us very...

Speaker Change: Investigative sites, who were interested but people we hadn't contacted we're coming up to our booth and asking to talk to them.

Speaker Change: About potentially getting their patients into the clinical trials. So there's a lot of excitement out there around the program, which is keeping us very excited.

Andreas Grauer: and Steve Eur, and Andreas, collectively your views of the phase three program and upcoming, I mean, do you anticipate any change in the response we're seeing in patients between the phase two program and what we could, what we could see in the phase three? Well, I think even in the phase two, although the phase two studies are not really small, we've treated a fairly representative set of patients. And so we expect to see very similar results in the Phase Three program. I agree, everything's going to be good.

Gregory Demopulos: And Steve your and Andreas collectively your views of the phase three program and upcoming I'm in.

Gregory Demopulos: Do you anticipate any change in the response we're seeing in patients between the Phase 2 program and what we could see in Phase 3?

Speaker Change: Do you see any.

Speaker Change: You anticipate any change.

Gregory Demopulos: And the response, we're seeing in patients between the phase II program and what we could what we could see in the phase III.

Speaker Change: Well I think even in the phase II.

Speaker Change: Phase III studies are naturally small links between get there fairly representative set so patients.

Speaker Change: And so we.

Speaker Change: You can expect to see.

Speaker Change: Similar results in the Phase III program.

Speaker Change: I agree with everything.

Olivia Brayer: Okay, thanks, Olivia. Thank you very much.

Speaker Change: Okay. Thanks Olivia.

Speaker Change: Thank you very much.

Serge Belanger: And our next question comes from Serge Belanger with Needham and Company. Your line is open.

Gregory Demopulos: Yeah.

Gregory Demopulos: And our next question comes from Sergey Bellinger with Needham <unk> Company. Your line is open.

Serge Belanger: Hi, this is a chat on research today. I just have my first question regarding a Zeltanavart and the C3G program. You're currently still enrolling patients for the Phase Two study.

Speaker Change: Search is that.

Speaker Change: Hi, there.

Gregory Demopulos: Hi, This is Jonathan on for Sage today.

Speaker Change: So my first question.

Speaker Change: Regarding del tenant of ours.

Speaker Change: The <unk> program.

Speaker Change: You are currently still enrolling patients for the phase two study do you have any timeline set too.

Gregory Demopulos: Do you have any timeline set to complete that study ahead of the potential launch and one in the first quarter of next year, whether or not there could be any potential overlap between phase two and phase three during that time. And then. Good.

Speaker Change: To complete that study.

Speaker Change: Ahead of the potential launch in <unk> in the first quarter of next year, and whether or not there could be any potential overlap between phase two and phase III during that time.

Speaker Change: And then it sounds like that.

Gregory Demopulos: No.

Speaker Change: Got it.

Gregory Demopulos: But.

Andreas Grauer: And then just my second question was regarding OMS 1029. You're expecting data in the third quarter of this year. How quickly do you think, you know, pending good data? How quickly do you think you'd be able to get this into the clinic following the study? Thanks.

Gregory Demopulos: And then just my second question was regarding LMS 10 29.

Speaker Change: Youre expecting data in the third quarter of this year.

Speaker Change: How quickly do you think.

Speaker Change: Pending data how quickly do you think you'd be able to get this into the clinic.

Speaker Change: Following this study.

Gregory Demopulos: Well, let me first, I'll hand this off to clinical in a moment, but as I mentioned, we think that we will have data from the C3G Phase 2 study later this year or early next. And also, as I noted, we're planning to initiate the Phase 3 program early in 2025. But let me, Steve, again, do you want to take this on C3G and the question about potential overlap between Phase 2 and Phase 3? Sure.

Gregory Demopulos: Well, let me first hand this off to clinical in a moment. But, as I mentioned, we think that we will have data from the C3G space two study later this year or early next. And also, as I noted, we're planning to initiate the phase three program early in 2025.

Speaker Change: Okay, well, let me first of all I'll hand, this off to clinical in a moment, but as I mentioned.

Gregory Demopulos: We think that we will have data from the <unk> phase III study later this year or early next and also as I noted, we're planning to initiate the phase III program.

Steve: In 2025.

Steve Whitaker: But let Steve, again, do you want to take this on C3G and the question about potential overlap of a phase two and phase three? Sure. I would actually anticipate having an overlap between phase two and phase three. The Phase Two study has your improvement. And if you recall, I believe it was seven patients that no artist presented at a Nash meeting or an ERA meeting. So you can get a good sense of efficacy with small numbers of patients in an open-label study. So we would, as soon as we gather the data to see a strong efficacy signal, we would start initiating phase three activities immediately before we run the study out completely.

Gregory Demopulos: But.

Gregory Demopulos: Steve do you want to take this on sheet through June the question about potential overlap of our phase II and post for sure I would actually anticipate having an overlap between phase II and phase III and phase II study has your treatment and if you recall I believe it was seven patients with Novartis.

Steve: Presented as Nash meeting or DRA meeting. So you can get a good sense of efficacy with small numbers of patients in an open label study. So we would as soon as we gather the data to see a strong efficacy signal, we would start initiating phase III activities immediately before we run the study out completely.

Gregory Demopulos: Right.

Andreas Grauer: Thank you. Your second question about 1029 was how quickly following data, we think we could be in the clinic. And I'm assuming meaning in the clinic in a phase two study. Andreas, do you have any thoughts on that? Well, I mean that if the data are as clear as we would hope, then I think we would get right to finalizing a clinical trial design. We would get the necessary input from the opinion leaders in the field to make sure that the trial design makes sense and will deliver a clear answer. I would expect us to move into the clinic sometime early in 2025.

Steve: Thank you <unk>.

Speaker Change: Question about about $10 29 was how quickly following data we think we could be in there.

Steve: The client can I'm, assuming meaning in the clinic in a phase II study.

Gregory Demopulos: Andreas do you have any thoughts on that.

Gregory Demopulos: Bob.

Steve: It's the data are as clear as we would hope then I think we would get bright to finalizing our clinical trial design would get the necessary input from.

Steve: Onion leaders in the field to make sure that the trial design makes sense symbol.

Steve: Deliver a clear answer.

Steve: So I would <unk>.

Steve: Spect us to move into the clinic sometime early in 2025.

Andreas Grauer: Right.

Gregory Demopulos: Great.

Andreas Grauer: Yeah, again, the objective of the primate study is to run a comparator. So we're looking at the effects of 1029 versus Ilya in these animals. So we think that that model is representative or pretty well predictive of what one would see in the human. And that way I think we'll get a pretty good sense coming out of these primate studies. And as Andreas said, we're hoping to see the data that we expect. Okay, thank you.

Gregory Demopulos: Again.

Steve: The objective of the Primate study is to run a comparator.

Steve: So we're looking at the.

Steve: The effects of <unk> 29 versus Eylea in these animals. So we.

Steve: We think that that model.

Gregory Demopulos: As.

Steve: As representative.

Gregory Demopulos: Or.

Steve: Pretty well predictive of what one would see in the human.

Gregory Demopulos: And.

Steve: That way I think we will get a pretty good sense coming out of these primates studies.

Steve: As Andreas said, we're hoping to see the data that we expect.

Gregory Demopulos: Okay.

Steve: Great. Thank you.

Gregory Demopulos: Thanks.

Unknown Executive: This does conclude our question and answer session.

Gregory Demopulos: This does conclude our question and answer session I would now like to turn it back Doctor Demopoulos for final remarks.

Gregory Demopulos: I would now like to turn it back to Dr. Demopoulos for final remarks. Thank you, operator. And again, thank you all for joining this afternoon. I think we've laid out a clear path around how we are advancing our program. We are really quite excited about the data we're generating. I know there again remains the question about Narsoplamab in everyone's mind and timing. We are confident in the effect of Narsoplamab in these patients, the need for Narsoplamab in these patients. And we expect we're going to get there. As Kathy made clear, can't give you the win right now.

Speaker Change: Thank you operator and again, thank you all for joining.

Steve: This afternoon.

Gregory Demopulos: I think we've laid out the effect of narsoplamab in these patients, the need for narsoplamab in these patients, and we expect we're going to get there. As Kathy made clear, we can't give you the when right now, but as soon as we have a better sense of the when, we will.

Operator: This concludes the program. You may now disconnect.

Steve: I think we've laid out.

Kathy: Clear paths around how we are advancing.

Operator: Our program.

Speaker Change: We are really quite excited about the data we're generating.

Speaker Change: So there again remains the question about <unk> in everyone's mind and timing.

Operator: We are confident in the.

Speaker Change: The affair.

Operator: Effect of <unk> in these patients the need for <unk> in these patients and we expect we're going to get there.

Operator: As Kathy made clear that give you the wind right now, but as soon as we have a better sense of the when we will.

Gregory Demopulos: But as soon as we have a better sense of the win, we will. But all of these programs are moving forward. And I think when you look at what's coming next in Zaltenabart, you know, certainly looks to be exciting.

Operator: But.

Speaker Change: All of these programs are moving forward and I think when.

Speaker Change: When you look at what's coming next then.

Operator: All 10 of our.

Kathy: Certainly it looks to be exciting so with that I will.

Unknown Executive: So, with that, I will thank you all for your continued support and have a good rest of the day.

Operator: Well thank you all.

Speaker Change: For your continued support.

Speaker Change: Have a good rest of the deck.

Unknown Executive: It concludes the program. You may now disconnect.

Operator: This concludes the program you may now disconnect.

Operator: Yes.

Operator: [music].

Operator: Okay.

Operator: Okay.

Operator: [music].

Operator: Yes.

Operator: Yes.

Operator: Yes.

Operator: Yes.

Operator: [music].

Operator: Yes.

Operator: Sure.

Operator: Yes.