Omeros Corp (OMER) 2023 Q3 法說會逐字稿

Good afternoon and welcome to today's earnings call for Omeros Corporation. (Operator Instructions)

下午好，歡迎參加今天的 Omeros Corporation 財報電話會議。 （操作員說明）

Please be advised that this call is being recorded at the company's request, and a replay will be available on the company's website for one week from today. I'll turn the call over to Jennifer Williams, Investor Relations for Omeros. Please go ahead.

請注意，本次通話是應公司要求進行錄音的，從今天起一週內將在公司網站上提供重播。我會將電話轉給 Omeros 投資者關係部門的 Jennifer Williams。請繼續。

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.

下午好，感謝您今天加入通話。我想提醒大家，今天的電話會議上發表的一些聲明將具有前瞻性。這些陳述僅基於管理層截至今天的信念和期望，並且可能會發生變化。

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.

所有前瞻性陳述均涉及風險和不確定性，可能導致本公司的實際結果出現重大差異。請參閱今天向 SEC 提交的公司 10-Q 表格季度報告中有關前瞻性陳述的特別說明，以及公司最新 10-K 表格年度報告中的風險因素部分進行討論這些風險和不確定性。

Now I would like to turn the call over to Dr. Greg Demopulos, Chairman and CEO of Omeros.

現在我想將電話轉給 Omeros 董事長兼執行長 Greg Demopulos 博士。

Thank you, Jennifer, and good afternoon, everyone. I'm joined today by Mike Jacobsen, Nadia Dac and Cathy Melfi, our respective heads of finance, commercial, and regulatory, along with Steve Whitaker, our VP of Clinical Development, and Andreas Grauer, who recently joined Omeros as Chief Medical Officer. Again, welcome, Andreas.

謝謝你，詹妮弗，大家下午好。今天加入我的還有我們各自的財務、商業和監管主管 Mike Jacobsen、Nadia Dac 和 Cathy Melfi，以及我們的臨床開發副總​​裁 Steve Whitaker 和最近加入 Omeros 擔任首席醫療官的 Andreas Grauer。再次歡迎，安德烈亞斯。

We'll have a brief overview of our financial results for the third quarter, followed by a corporate update. Mike will then provide a more detailed financial summary before we open the call to questions.

我們將簡要概述第三季的財務業績，然後介紹公司最新情況。然後，在我們開始提問之前，麥克將提供更詳細的財務摘要。

First, though, in the wake of our stopping the ARTEMIS-IGAN trial, I'd like to address our near to mid-term high level program strategy.

不過，首先，在我們停止 ARTEMIS-IGAN 試驗之後，我想談談我們的近中期高水準計畫策略。

To anyone paying attention to our programs and their development progress, it should be clear that our company is strong and well positioned for success. Of course, we're conducting a deep dive into our ARTEMIS-IGAN trial data.

對於任何關注我們的專案及其開發進度的人來說，都應該清楚我們公司實力雄厚，並且為成功做好了準備。當然，我們正在深入研究 ARTEMIS-IGAN 試驗數據。

And there's more work to be done there to learn what specifically happened, why we see an outsized placebo effect, whether there are subgroups of patients who responded well to narsoplimab, and how we can make use of newly developing biomarkers to understand better the role of lectin pathway inhibition in IgA nephropathy and in kidney diseases more broadly.

還有更多的工作要做，以了解具體發生了什麼，為什麼我們看到了巨大的安慰劑效應，是否存在對narsoplimab 反應良好的患者亞組，以及我們如何利用新開發的生物標誌物來更好地了解IgA 腎病和更廣泛的腎臟疾病中的凝集素途徑抑制。

This examination will not only pay benefits to our MASP-2 program, including OMS1029, but will also help us design and execute clinical trials in kidney diseases for OMS906, our MASP-3 inhibitor.

這項檢查不僅將為我們的 MASP-2 計畫（包括 OMS1029）帶來好處，還將幫助我們設計和執行 MASP-3 抑制劑 OMS906 的腎臟疾病臨床試驗。

While we expect to resolve these and other questions that we have on the ARTEMIS-IGAN trial, our top priorities are focused on near-term value-driving catalysts, specifically, one, achieving approval and successful market launch for our narsoplimab in hematopoietic stem cell transplant-associated thrombotic microangiopathy or TA-TMA mid next year.

雖然我們希望解決 ARTEMIS-IGAN 試驗中遇到的這些問題和其他問題，但我們的首要任務是專注於近期價值驅動催化劑，具體來說，一是我們的 narsoplimab 在造血幹細胞中獲得批准並成功上市移植相關血栓性微血管病變或TA-TMA 將於明年年中進行。

Two, driving two Phase-3 clinical trials for our MASP-3 inhibitor, OMS906, both in paroxysmal nocturnal hemoglobinuria or PNH and in C3 glomerulopathy. Both Phase 3 programs targeted to initiate in the third quarter of next year.

第二，推動我們的 MASP-3 抑制劑 OMS906 的兩項 3 期臨床試驗，兩項試驗均針對陣發性睡眠性血紅素尿症 (PNH) 和 C3 腎絲球病變。這兩個第三階段計劃都計劃在明年第三季啟動。

Three, moving OMS1029, our long acting mask two inhibitor into Phase 2 clinical trials by next summer in a larger market indication.

第三，到明年夏天將我們的長效面膜二抑制劑 OMS1029 納入更大的市場適應症的 2 期臨床試驗。

And four, taking our current cash runway projected to be well into 2025 and extended well into 2026 or beyond without dilution to shareholders.

第四，我們目前的現金跑道預計將持續到 2025 年，並​​延長到 2026 年或更長時間，而不會對股東造成稀釋。

We believe that each of these four strategic objectives can be achieved. In parallel, we remain laser focused on cost containment and are assessing a range of additional cost reduction measures for implementation while balancing them with ensuring that we invest the necessary resources to achieve our near term value-driving objectives.

我們相信這四個戰略目標都是可以實現的。同時，我們仍然高度關注成本控制，並正在評估一系列額外的成本削減措施的實施，同時平衡這些措施，確保我們投資必要的資源來實現我們的近期價值驅動目標。

As part of these cost containment efforts, the funds previously earmarked for the two-year continuation of the ARTEMIS-IGAN and related commercialization will be reallocated to extending runway and to our other later stage programs, with a good part of that reallocation going to accelerate and broaden development of OMS906, our alternative pathway targeting MASP-3 inhibitor.

作為這些成本控制工作的一部分，先前指定用於 ARTEMIS-IGAN 持續兩年和相關商業化的資金將被重新分配給延伸跑道和我們的其他後期項目，其中很大一部分將加速並擴大OMS906 的開發， OMS906 是我們針對MASP-3 抑制劑的替代途徑。

To summarize, the bulk of our development expenditures in the near to midterm will be directed to approval and market launch of narsoplimab in TA-TMA, driving OMS906 towards successful completion of its Phase 3 clinical programs, and proving the value of OMS1029.

總而言之，我們在近中期的大部分開發支出將用於 TA-TMA 中 narsoplimab 的批准和上市，推動 OMS906 成功完成其 3 期臨床項目，並證明 OMS1029 的價值。

Our PDE7 inhibitor, OMS527, will continue advancing through its multi-year funding from the National Institute on Drug Abuse or NIDA. In addition, we intend to move ahead with certain work advancing the seminal discoveries in our immuno-oncology program.

我們的 PDE7 抑制劑 OMS527 將透過國家藥物濫用研究所 (NIDA) 的多年資助繼續推進。此外，我們打算推進某些工作，以推進我們的免疫腫瘤學計畫的開創性發現。

Our spending on these programs has been relatively small to date as the large majority of the efforts across our five novel I-O platforms are conducted in-house by a relatively small, but extremely effective group of scientists. We believe that a limited additional investment in these programs could catalyze significant asset value in the programs potentially in the near term.

到目前為止，我們在這些項目上的支出相對較小，因為我們五個新穎的 I-O 平台的大部分工作都是由相對較小但極其有效的科學家團隊在內部進行的。我們認為，對這些計劃進行有限的額外投資可能會在短期內促進這些計劃的重大資產價值。

Now let's turn to our financial results. Our net loss for the third quarter of 2023 was $37.8 million or $0.60 per share compared to a net loss of $37.3 million or $0.59 per share in the second quarter of this year. Cash burn for the third quarter of 2023 was $31 million.

現在讓我們來看看我們的財務表現。我們 2023 年第三季的淨虧損為 3,780 萬美元，即每股 0.60 美元，而今年第二季的淨虧損為 3,730 萬美元，即每股 0.59 美元。 2023 年第三季的現金消耗為 3,100 萬美元。

OMIDRIA royalties for the third quarter were $10 million, and that's a $700,000 decrease over second quarter royalties. This is consistent with historically fewer cataract procedures performed during the summer months.

OMIDRIA 第三季的特許權使用費為 1,000 萬美元，比第二季的特許權使用費減少了 70 萬美元。這與歷史上夏季進行的白內障手術較少是一致的。

As of September 30, 2023, we had $310.3 million of cash and investments on hand. Omeros has $95 million of convertible debt maturing November 15 of this year, which we plan to retire. Even after retiring the 2023 notes, our current available cash and investments should enable us to fund our operations and continue advancing our multiple programs well into 2025.

截至 2023 年 9 月 30 日，我們手頭上有 3.103 億美元的現金和投資。 Omeros 擁有 9,500 萬美元的可轉換債務，將於今年 11 月 15 日到期，我們計劃償還這些債務。即使在停用 2023 年票據後，我們目前可用的現金和投資也應該能夠為我們的營運提供資金，並繼續推進我們的多個項目直至 2025 年。

And as I noted just a few moments ago, we are evaluating options to extend that runway non-dilutively well into 2026 or beyond.

正如我剛才指出的那樣，我們正在評估將這條跑道以非稀釋性方式延長至 2026 年或更長的選項。

Last week, CMS issued the final rule for its 2024 Hospital Outpatient Prospective Payment System. In that rule, CMS recommitted to separate payment for OMIDRIA in ambulatory surgery centers or ASCs throughout 2024.

上週，CMS 發布了 2024 年醫院門診預期支付系統的最終規則。在該規則中，CMS 再次承諾在 2024 年期間在門診手術中心或 ASC 中單獨支付 OMIDRIA 費用。

Beginning January 1, 2025, as mandated by Congress in this year's Consolidated Appropriations Act, CMS will pay separately for OMIDRIA in both hospital outpatient departments and in ASCs until at least January 1, 2028.

從 2025 年 1 月 1 日開始，根據國會在今年的《綜合撥款法案》中的規定，CMS 將分別支付醫院門診部和 ASC 的 OMIDRIA 費用，至少持續到 2028 年 1 月 1 日。

Historically, when OMIDRIA is separately paid in hospital outpatient departments, OMIDRIA sales in those facilities have represented an additional roughly 33% on top of sales in ASCs.

從歷史上看，當 OMIDRIA 在醫院門診中單獨支付時，這些機構中的 OMIDRIA 銷售額比 ASC 銷售額高出約 33%。

Let's turn now to our program updates. Starting first with our family of agents targeting MASP-2, the effector enzyme of the lectin pathway of complement.

現在讓我們來看看我們的程式更新。首先從我們針對 MASP-2 的藥物家族開始，MASP-2 是補體凝集素途徑的效應酵素。

On October 16, we announced genuinely surprising and disappointing preliminary results of the prespecified interim analysis in our Phase 3 ARTEMIS-IGAN trial evaluating narsoplimab for the treatment of IgA nephropathy.

10 月 16 日，我們宣布了 3 期 ARTEMIS-IGAN 試驗中預先指定的中期分析的初步結果，該試驗評估了 narsoplimab 治療 IgA 腎病的效果，結果令人驚訝且令人失望。

Top line results showed that narsoplimab did not reach statistically significant improvement over placebo on the primary endpoint of reduction in proteinuria assessed by 24-hour urine protein excretion at 36 weeks in the intent-to-treat population comprised of 180 IgA nephropathy patients, all of whom had baseline proteinuria levels above two grams per day. So severe IgA patients.

最重要的結果顯示，在由180 名IgA 腎病患者組成的意向治療人群中，通過36 週時24 小時尿蛋白排泄評估的蛋白尿減少這一主要終點，narsoplimab 與安慰劑相比沒有達到統計學上的顯著改善。基線蛋白尿水平超過每天兩克。所以重症IgA患者。

Based on the absence of a statistically significant improvement on the proteinuria endpoint and as agreed with FDA, the clinical trial has been discontinued.

由於蛋白尿終點沒有統計學上顯著的改善，且經 FDA 同意，臨床試驗已停止。

As we noted during our conference call on October 16, the proteinuria reduction observed in the placebo group was substantially greater than in Phase 3 clinical trials on other agents in IgA nephropathy. Had the placebo effect in our trial been consistent with the placebo effect in those other trials, our trial would have met statistical significance.

正如我們在 10 月 16 日的電話會議上指出的那樣，在安慰劑組中觀察到的蛋白尿減少量明顯大於其他 IgA 腎病藥物的 3 期臨床試驗。如果我們試驗中的安慰劑效應與其他試驗中的安慰劑效應一致，我們的試驗就會達到統計顯著性。

Our deep dive analysis of the IgA data from our trial is underway. As I mentioned a bit earlier, what we learn from that analysis should be applicable not only to our MASP-2 lectin pathway programs, but also to our programs for our alternative pathway, MASP-3 inhibitor, OMS906.

我們正在對試驗中的 IgA 數據進行深入分析。正如我之前提到的，我們從該分析中學到的知識不僅適用於我們的 MASP-2 凝集素途徑計劃，還適用於我們的替代途徑 MASP-3 抑制劑 OMS906 的計劃。

Remember that alternative pathway inhibition has now been clinically validated as an effective treatment for kidney disease. And this bodes well for OMS906 and it's expanding range of potential indications.

請記住，替代途徑抑制現已被臨床驗證為治療腎臟疾病的有效方法。這對 OMS906 來說是個好兆頭，它正在擴大潛在適應症的範圍。

So despite the outcome of ARTEMIS-IGAN, the evidence supporting the role of the lectin pathway and kidney disease and the therapeutic potential of MASP-2 inhibition remained strong.

因此，儘管 ARTEMIS-IGAN 取得了成果，但支持凝集素途徑和腎臟疾病的作用以及 MASP-2 抑制的治療潛力的證據仍然很強。

That said, any future development of lectin pathway inhibitor for IgA nephropathy or other indications that similarly require long-term chronic dosing are better suited for OMS1029, our next generation long acting MASP-2 inhibitor.

也就是說，未來任何針對 IgA 腎病或其他類似需要長期慢性給藥的適應症的凝集素途徑抑制劑的開發都更適合 OMS1029，我們的下一代長效 MASP-2 抑制劑。

OMS1029 has successfully completed a Phase 1 single ascending dose study in healthy subjects and the resultant pharmacokinetic and pharmacodynamic or PK/PD data support dosing of OMS1029 once quarterly, either subcutaneously or intravenously.

OMS1029 已在健康受試者中成功完成了一項 1 期單劑量遞增研究，所得藥物動力學和藥效學或 PK/PD 數據支持 OMS1029 每季度一次皮下或靜脈注射給藥。

A Phase 1 multiple ascending dose study of OMS1029 is ongoing, and we expect to initiate next summer, a Phase 2 program for OMS1029.

OMS1029 的 1 期多劑量遞增研究正在進行中，我們預計明年夏天啟動 OMS1029 的 2 期計畫。

Another of our four near term strategic objectives, the approval and successful market launch of narsoplimab for patients with TA-TMA, is right now a key focus of our company. We have submitted to FDA a formal statistical analysis plan to compare survival from our narsoplimab pivotal clinical trial to that of an external control, specifically a large registry of TA-TMA patients.

我們的四個近期策略目標中的另一個是針對 TA-TMA 患者的 narsoplimab 的批准和成功上市，這是我們公司目前的重點。我們已向 FDA 提交了一份正式的統計分析計劃，以比較我們的 narsoplimab 關鍵臨床試驗與外部對照（特別是 TA-TMA 患者的大型登記）的生存率。

The statistical analysis plan was developed by a well-respected biostatistical group independent of Omeros, and without having examined the survival data to be used in the comparative analysis. Assuming FDA agrees with the plan, we expect the biostatistical group to conduct the analysis. And if the results are supportive, we intend to resubmit the biologics license application or BLA for narsoplimab in TA-TMA soon thereafter, which should allow for an FDA decision on approval mid next year.

統計分析計劃是由獨立於 Omeros 的備受尊敬的生物統計小組制定的，並且沒有檢查用於比較分析的生存數據。假設 FDA 同意該計劃，我們預計生物統計小組將進行分析。如果結果是支持性的，我們打算不久後重新提交 TA-TMA 中 narsoplimab 的生物製劑許可申請或 BLA，這將允許 FDA 在明年中期做出批准決定。

To minimize the time to an approval decision, we have already begun revising those modules of the BLA resubmission that require revision, that includes revising the CMC module of the BLA in accordance with the agreements reached during our meeting last month with FDA's CMC review team assigned to our BLA.

為了最大限度地縮短批准決定的時間，我們已經開始修改 BLA 重新提交的那些需要修改的模組，其中包括根據我們上個月與 FDA 指定的 CMC 審查小組的會議期間達成的協議修改 BLA 的 CMC 模組到我們的BLA。

We also intend to include in our BLA resubmission, real-world data on over 120 TA-TMA patients treated with narsoplimab under our compassionate-use program.

我們還打算在重新提交的 BLA 中納入根據我們的同情使用計劃接受 narsoplimab 治療的 120 多名 TA-TMA 患者的真實數據。

For each of these adult and pediatric patients, we have provided narsoplimab at no charge, well, not financially sustainable long term. As compassionate-use results show more and more evidence of strong survival outcomes, we feel an increasingly strong obligation to provide access narsoplimab for high-risk TA-TMA patients, while the drug continues to proceed through the regulatory process.

對於每一位成人和兒童患者，我們免費提供 narsoplimab，但從長遠來看，這在經濟上是不可持續的。隨著同情用藥結果顯示越來越多的證據表明良好的生存結果，我們感到越來越有義務為高風險 TA-TMA 患者提供 narsoplimab，同時該藥物繼續通過監管程序。

The outcomes of a large number of compassionate-use TA-TMA patients treated with narsoplimab have been reported in peer reviewed journal and International Congress publications. The patients have ranged in age from three months to over 70 years.

在同行評審期刊和國際大會出版物中報告了大量接受 narsoplimab 治療的同情用藥 TA-TMA 患者的結果。患者的年齡從三個月大到70多歲不等。

The most recent publication, an abstract to be presented at the upcoming annual meeting of the American Society of Hematology details the clinical and survival benefits of narsoplimab in 15 adult and pediatric compassionate-use patients, 14 of whom had high-risk TA-TMA.

最近發表的摘要將在即將舉行的美國血液學會年會上發表，詳細介紹了narsoplimab 在15 名成人和兒童同情用藥患者中的臨床和生存獲益，其中14 名患者患有高風險TA-TMA 。

73% were deemed responders with 100 days survival achieved by 80% of all patients in the study and by 100% of the responders. As in all other studies, narsoplimab was generally well tolerated without any safety signals of concern.

73% 的患者被視為有反應者，研究中 80% 的患者和 100% 的有反應者實現了 100 天存活率。與所有其他研究一樣，narsoplimab 通常具有良好的耐受性，沒有任何令人擔憂的安全訊號。

Our work with narsoplimab in COVID-19 and acute respiratory distress syndrome or ARDS presents another opportunity for continued development of narsoplimab in a group of indications centered around ARDS for which there is strong and widely-published mechanistic evidence as well as proof-of-concept clinical data.

我們與narsoplimab 在COVID-19 和急性呼吸窘迫綜合徵或ARDS 中的合作為narsoplimab 在一組以ARDS 為中心的適應症中的持續開發提供了另一個機會，這些適應症有強有力且廣泛發表的機制證據以及概念驗證臨床數據。

Narsoplimab is particularly well suited for diseases like ARDS, acute indications requiring hospitalization. We continue making significant progress and further characterizing the lectin pathways central role in COVID-19 and ARDS. Two weeks ago, a manuscript was published in the Journal of Infectious Diseases describing the benefits of MASP-2 blockade and lectin pathway inhibition on diseased lungs and brains as well as on survival in a well-established animal model of COVID-19 related ARDS.

Narsoplimab 特別適合治療 ARDS 等需要住院治療的急性適應症等疾病。我們繼續取得重大進展，並進一步表徵凝集素途徑在 COVID-19 和 ARDS 中的核心作用。兩週前，《傳染病雜誌》上發表了一篇手稿，描述了MASP-2 阻斷和凝集素通路抑制對患病肺部和大腦以及對已建立的COVID-19 相關ARDS 動物模型生存的益處。

Treatment of infected mice with a MASP-2 inhibitor significantly reduced disease severity scores and improved survival rates compared to the control antibody, specifically MASP-2 inhibition significantly reduced lung infiltrates, adenoma and hemorrhage [18.02], while also significantly reducing and normalizing brain inflammation and associated hyper activation of brain microglia. Discussions continue with US government agencies around both COVID-19 and ARDS.

與對照抗體相比，MASP-2 抑制劑治療感染小鼠可顯著降低疾病嚴重程度評分並提高存活率，特別是MASP-2 抑制可顯著減少肺部浸潤、腺瘤和出血[18.02] ，同時也顯著減少腦部發炎並使其正常化以及相關的大腦小膠質細胞的過度活化。與美國政府機構繼續就 COVID-19 和 ARDS 進行討論。

Multiple labs have recently identified lectin pathway hyper activation as prominently present in patients with long COVID at both 6 and 12 months following resolution of their acute SARS-CoV-2 infection. Here again, the data suggest a potential role of narsoplimab and MASP-2 inhibition in the treatment of not only acute but also long COVID.

多個實驗室最近發現，長期 COVID 患者在急性 SARS-CoV-2 感染消退後 6 個月和 12 個月內明顯存在凝集素路徑過度活化。數據再次顯示 narsoplimab 和 MASP-2 抑制不僅在治療急性新冠肺炎，而且在治療長期新冠肺炎方面具有潛在作用。

To date the challenges in assessing a therapeutic in long COVID are the lack of standardization in diagnostic criteria and in clinical endpoints. Progress is being made internationally on both fronts. And we are assessing next steps.

迄今為止，評估長期新冠肺炎治療方法的挑戰是診斷標準和臨床終點缺乏標準化。國際上在這兩方面都取得了進展。我們正在評估後續步驟。

In parallel, we have developed published and filed a broad patent internationally on an assay platform that can identify and discriminate between mild COVID-19 patients and those who have moderate or severe COVID-19 requiring hospitalization.

同時，我們也在一個檢測平台上開發了一項已發表並在國際上申請的廣泛專利，該平台可以識別和區分輕度COVID-19 患者和需要住院治療的中度或重度COVID-19患者。

The assay's novelty and core measurement is the MASP-2 C1 inhibitor complex, a highly sensitive and specific marker of lectin pathway hyper activation. We believe that this assay has the potential to predict those patients who have a high likelihood of progressing to severe COVID and COVID-related ARDS. This would be a win-win for patients, physicians, and the payer system.

此測定的新穎性和核心測量是 MASP-2 C1 抑制劑複合物，它是凝集素途徑過度活化的高度敏感和特異性標記物。我們相信，該檢測有可能預測那些很有可能進展為嚴重新冠肺炎和新冠肺炎相關急性呼吸窘迫症候群的患者。這對患者、醫生和支付系統來說將是雙贏。

We also believe that our assays utility could well expand beyond acute COVID to include both long COVID and other disease related ARDS. To our knowledge, there is no commercially available assay that can similarly identify at-risk patients in acute COVID, long COVID or ARDS. We're evaluating our options for completing development and commercialization of this assay.

我們也相信，我們的檢測實用程式可以很好地擴展到急性新冠肺炎之外，包括長期新冠肺炎和其他疾病相關的急性呼吸窘迫症候群。據我們所知，目前還沒有商業化的檢測方法可以類似地識別急性新冠肺炎、長期新冠肺炎或急性呼吸窘迫症候群的高風險患者。我們正在評估完成該檢測的開發和商業化的選擇。

We've also made good progress in our orally-administered MASP-2 inhibitor program. Our objective across the masp-2 franchise is to control exclusively the full range of therapeutics for lectin pathway related diseases, and that includes oral therapies.

我們的口服 MASP-2 抑制劑計畫也取得了良好進展。我們在 masp-2 特許經營權中的目標是獨家控制凝集素途徑相關疾病的全系列治療方法，其中包括口服療法。

We have selected a drug development candidate as well as a backup candidate, both of these orally delivered in testing to enable the filing of an investigational new drug application is underway.

我們已經選擇了一種藥物開發候選藥物和一種備用候選藥物，這兩種藥物都進行了口頭測試，以便能夠提交研究性新藥申請。

Let's now focus on OMS906. Our lead antibody targeting mass barrier on the alternative pathway of complement. Inhibition of the alternative pathway continues to be validated clinically by other alternative pathway inhibitors in a wide range of diseases.

現在讓我們關注OMS906。我們的先導抗體靶向補體替代途徑上的質量屏障。旁路途徑的抑製作用繼續透過其他旁路途徑抑制劑在多種疾病中得到臨床驗證。

This growing set of indications endures to the value of OMS906. Recent examples of this are the clinical validation of alternative pathway inhibition in IgA nephropathy and in geographic atrophy.

這些不斷增長的適應症體現了 OMS906 的價值。最近的例子是 IgA 腎病和地圖樣萎縮中替代途徑抑制的臨床驗證。

In our PNH program, we previously disclosed encouraging data from an interim analysis in our Phase 2 clinical trial evaluating OMS906 in PNH patients who have not previously been treated with a complement inhibitor.

在我們的 PNH 計畫中，我們先前揭露了 2 期臨床試驗中一項中期分析的令人鼓舞的數據，該試驗評估了 OMS906 在先前未接受過補體抑制劑治療的 PNH 患者中的作用。

An abstract with new and updated data from this study of treatment-naive PNH patients has been selected for oral presentation at the annual congress of the American Society of Hematology or ASH coming up this December.

這項針對初治 PNH 患者的研究的新數據和更新數據摘要已被選為在今年 12 月舉行的美國血液學會 (ASH) 年度大會上進行口頭報告。

The presentation describes the clinically meaningful beneficial effects of OMS906 on hemoglobin, LDH, and red blood cell clone size in PNH patients. 11 patients are enrolled in the study, all of whom had reached the four-week time point and three of whom had reached the 24-week time point at the time of interim data capture.

此簡報描述了 OMS906 對 PNH 患者的血紅蛋白、LDH 和紅血球克隆大小的具有臨床意義的有益影響。 11 名患者參與了研究，在中期數據採集時，所有患者均已達到 4 週時間點，其中 3 名患者已達到 24 週時間點。

Following initiation of OMS906, mean hemoglobin increased from baseline by 3.1 grams per deciliter at four weeks and by 9.5 grams per deciliter at the latest time point of 24 weeks. All but three of the patients achieved gender-specific normalization of hemoglobin levels.

開始使用 OMS906 後，平均血紅素在 4 週時較基線增加 3.1 克/分升，在最近的 24 週時間點增加 9.5 克/分升。除三名患者外，所有患者均實現了性別特異性血紅蛋白水平正常化。

The remaining patients had concomitant diseases causing bone marrow suppression of red blood cell production, unrelated to PNH, but preventing normalization of hemoglobin levels.

其餘患者則患有導致骨髓紅血球生成抑制的伴隨疾病，與 PNH 無關，但妨礙血紅素水平正常化。

No patients required transfusion following OMS906 treatment, mean LDH levels decreased from baseline by approximately 1,500 units per liter at four weeks and by nearly 2000 units per liter at 24 weeks. Mean PNH RBC clone size increased by up to 39% versus baseline.

OMS906 治療後沒有病人需要輸血，平均 LDH 水準在 4 週時較基線下降約 1,500 單位/公升，在 24 週時下降近 2000 單位/公升。與基線相比，平均 PNH RBC 克隆大小增加高達 39%。

The second OMS906 abstract was also accepted for presentation at ASH. This one is directed to in vitro and in vivo mechanistic support for the clinical efficacy of OMS906 in PNH patients. Our second Phase 2 study in PNH patients, our switch-over study is now fully enrolled.

第二份 OMS906 摘要也被接受在 ASH 上發表。這項研究旨在為 OMS906 在 PNH 患者的臨床療效提供體外和體內機制支持。我們針對 PNH 患者的第二項 2 期研究，即轉換研究現已全部入組。

As designed, this study enrolls PNH patients receiving the C5 inhibitor, ravulizumab, adds OMS906 to provide combination therapy with ravulizumab for 24 weeks. And then in those patients who demonstrate a hemoglobin response with the combination therapy switches to OMS906 monotherapy. We anticipate sharing data publicly from this study later this year or early next.

依照設計，本研究招募了接受 C5 抑制劑 ravulizumab 治療的 PNH 患者，並添加 OMS906 與 ravulizumab 合併治療 24 週。然後，對於那些對聯合療法表現出血紅蛋白反應的患者，改為 OMS906 單藥療法。我們預計在今年稍後或明年初公開分享這項研究的數據。

As part of our strategy to move as rapidly as possible through clinical development of OMS906 in this indication, we have now initiated an extension study designed to assess the long-term efficacy and safety of OMS906 in PNH patients. The study will enroll patients who have completed either of the two Phase 2 studies that I've just described, which both evaluate OMS906 for the treatment of PNH.

作為我們盡快推進 OMS906 在該適應症臨床開發的策略的一部分，我們現在已啟動一項擴展研究，旨在評估 OMS906 在 PNH 患者中的長期療效和安全性。該研究將招募已完成我剛才描述的兩項 2 期研究之一的患者，這兩項研究均評估 OMS906 治療 PNH 的效果。

Patients will roll from either of those trials directly into the extension study without a break in OMS906 treatments. Data from this study will contribute to the planned BLA for OMS906 in the treatment of PNH.

患者將從這些試驗中的任何一個直接進入擴展研究，而無需中斷 OMS906 治療。這項研究的數據將有助於 OMS906 治療 PNH 的計劃 BLA。

In addition to our clinical work in PNH, we have an OMS906 Phase 2 clinical program ongoing in C3G, a rare and debilitating kidney disease. Enrollment for this trial is slated to begin next month.

除了 PNH 的臨床工作外，我們還在 C3G（一種罕見且使人衰弱的腎臟疾病）中開展 OMS906 2 期臨床計劃。該試驗的招募定於下個月開始。

Consistent with our prioritized objectives, we are targeting to begin enrollment in our Phase 3 PNH trial and in our Phase 3 C3G trial in the third quarter of next year.

與我們的優先目標一致，我們的目標是在明年第三季開始參加 PNH 3 期試驗和 C3G 3 期試驗。

The latest OMS906 data now made public by ASH in advance of the presentation at the Society's annual congress in December, add to the compelling case that MASP-3 might well be the premier alternative pathway target, and OMS906, the premier alternative pathway drug.

ASH 在 12 月協會年度大會上發表演講之前公佈了最新的 OMS906 數據，這進一步證明 MASP-3 很可能是首要的替代途徑靶標，而 OMS906 是首要的替代途徑藥物。

We previously have detailed that we see as the major differentiators between MASP-3 and OMS906 versus other alternative pathway targets and therapeutics on the market or in development. And I won't repeat those detailed explanations of their advantages. They can be found in transcripts of earlier calls and in a slide presentation on our website.

我們之前已經詳細介紹過，我們認為 MASP-3 和 OMS906 與市場上或正在開發的其​​他替代途徑標靶和療法之間的主要區別在於。我不會重複那些關於它們的優點的詳細解釋。您可以在先前的通話記錄和我們網站上的幻燈片簡報中找到它們。

Instead, I'll simply summarize the highlights, and they are as follows: one, MASP-3 blockers do not inhibit the infection fighting function of the classical pathway of complement.

相反，我簡單總結一下重點，如下：一、MASP-3阻斷劑不會抑制補體經典途徑的抗感染功能。

By contrast, both C3 and C5 inhibitors block the classical pathway's adaptive immune response thereby increasing infection risk.

相較之下，C3 和 C5 抑制劑都會阻斷經典途徑的適應性免疫反應，進而增加感染風險。

Two, MASP-3 is known not to be in acute phase reactive and has very low native circulating levels relative to other alternative pathway targets.

第二，已知 MASP-3 不處於急性期反應性，且相對於其他替代途徑標靶具有非常低的天然循環水平。

In contrast, factor B, C3, and the terminal factor C5 are all acute phase reactive. This means that the concentrations of factor B, C3, and C5 increase in the setting of inflammation such as infection or any other inflammatory condition.

相反，因子 B、C3 和終末因子 C5 都是急性期反應性的。這意味著在感染或任何其他發炎等發炎情況下，因子 B、C3 和 C5 的濃度會增加。

As a result, OMS906 should maintain more consistent pathway inhibition, than drugs targeting factor B, C3 or C5, providing better protection against potentially life-threatening breakthrough of a patient's underlying disease.

因此，與針對 B、C3 或 C5 因子的藥物相比，OMS906 應保持更一致的通路抑制，從而提供更好的保護，防止患者潛在疾病的潛在危及生命的突破。

And three, OMS906 should deliver better patient convenience and compliance than the competition by allowing once-quarterly intravenous and subcutaneous administration.

第三，OMS906 允許每季靜脈和皮下給藥，為患者提供比競爭對手更好的便利性和依從性。

While we expect these three major advantages to provide significant differentiation over our competitors, those competitors also help us. They help us by continuing to validate indications clinically, providing a de-risked roadmap for us to follow with what we expect is a better target, MASP-3, and a better drug, OMS906.

雖然我們期望這三大優勢能夠使我們與競爭對手相比具有顯著的差異化，但這些競爭對手也為我們提供了幫助。它們透過繼續臨床驗證適應症來幫助我們，為我們提供一個去風險的路線圖，以便我們遵循我們期望的更好的標靶 MASP-3 和更好的藥物 OMS906。

So the data around OMS-906 continue to strengthen and the breadth of potential indications continues to expand. As a result, the value story for the entirety of the 906 program continues to improve.

因此，圍繞 OMS-906 的數據繼續加強，潛在適應症的廣度繼續擴大。因此，整個 906 計劃的價值故事不斷改善。

Our objective remains unchanged to make OMS906, the first-line standard of care for the treatment of PNH and a host of other alternative pathway diseases and disorders.

我們的目標保持不變，即使 OMS906 成為治療 P​​NH 和許多其他替代途徑疾病和病症的第一線護理標準。

Let's now move on to OMS527, our PDE7 inhibitor program targeting treatment of addictions and compulsive disorders. PDE7 inhibition has been shown in animal models to block both craving and relapse across multiple substances of abuse, including opioids, cocaine, nicotine, and alcohol.

現在讓我們繼續討論 OMS527，這是我們的 PDE7 抑制劑計劃，旨在治療成癮和強迫症。在動物模型中，PDE7 抑制已被證明可以阻止對多種濫用藥物的渴望和復發，包括鴉片類藥物、可卡因、尼古丁和酒精。

Importantly, PDE7 inhibition, unlike other any addiction agents on the market does not appear to depress the reward system. Depression of the reward system results in diminished enjoyment of other life activities, food, socialization, sex, sports.

重要的是，與市面上其他成癮劑不同，PDE7 抑制似乎不會抑制獎勵系統。獎勵系統的抑制會導致對其他生活活動、食物、社交、性、運動的享受減少。

And as a major cause of noncompliance with currently marketed any addiction agents, the ability of PDE7 inhibitors to avoid this side effect represents a significant advance in the treatment of substance use disorders.

作為目前市售任何成癮藥物不遵從的主要原因，PDE7 抑制劑避免這種副作用的能力代表了物質使用疾患治療的重大進步。

The potential indications for PDE inhibitors are not limited to substance use disorders, but extend to compulsive disorders with clear efficacy data in a well-established animal model of binge eating.

PDE 抑制劑的潛在適應症不僅限於物質使用障礙，還擴展到強迫症，並在完善的暴食動物模型中獲得了明確的療效數據。

The development of our PDE7 inhibitor program for addiction is currently fully funded by a grant from the National Institute on Drug Abuse, $6.7 million over three years. NIDA requested that we first develop OMS527 for the treatment of adults with cocaine-use disorder. The grant supports both preclinical and clinical work, including a randomized, double-blind inpatient clinical trial.

我們針對成癮的 PDE7 抑制劑計畫的開發目前完全由國家藥物濫用研究所撥款資助，為期三年 670 萬美元。 NIDA 要求我們先開發 OMS527，用於治療成人可卡因使用障礙。該撥款支持臨床前和臨床工作，包括隨機、雙盲住院臨床試驗。

In addition to the treatment of addictions and compulsions, Omeros controls broad patents surrounding PDE7 inhibition and movement disorders. Our clinical focus in movement disorders is the potential treatment of levodopa-induced dyskinesia or LID.

除了成癮和強迫症的治療之外，Omeros 還控制著有關 PDE7 抑制和運動障礙的廣泛專利。我們在運動障礙方面的臨床重點是左旋多巴引起的運動障礙或 LID 的潛在治療。

LID is a nearly universal and debilitating side effect of long-term treatment with L-DOPA in patients with Parkinson's disease causing crippling and involuntary movements in L-DOPA treated patients.

LID 是帕金森氏症患者長期接受 L-DOPA 治療時幾乎普遍存在的一種使人衰弱的副作用，導致接受 L-DOPA 治療的患者出現殘廢和不自主運動。

LID. is estimated to affect millions of Parkinson's patients worldwide, representing both a large unmet patient need and market opportunity. The only approved drug for LID has marginal efficacy and is fraught with significant adverse side effects.

蓋。據估計，該疾病將影響全球數百萬帕金森氏症患者，這不僅代表大量未滿足的患者需求，也代表著市場機會。唯一被批准用於治療 LID 的藥物療效有限，並且充滿明顯的不良副作用。

A more effective and safer treatment is needed. Primate studies assessing OMS527 in LID have been conducted at Emory University, and we are discussing next steps with our Emory colleagues.

需要更有效、更安全的治療。埃默里大學已經進行了評估 OMS527 在 LID 中的靈長類動物研究，我們正在與埃默里大學的同事討論下一步行動。

I will end today's corporate review with our immuno-oncology programs. Our broad I-O franchise consists of two cellular platforms and three molecular platforms.

我將以我們的免疫腫瘤學計畫結束今天的公司審查。我們廣泛的 I-O 特許經營權包括兩個細胞平台和三個分子平台。

Our two cellular platforms, our CAR-T and adoptive T cell therapy. Our three molecular platforms are immunomodulators, immunotoxins, and cancer vaccines.

我們的兩個細胞平台，我們的 CAR-T 和過繼性 T 細胞療法。我們的三個分子平台是免疫調節劑、免疫毒素和癌症疫苗。

All of these five platforms are entirely novel and based on substantial in vitro and in vivo data, all look to be viable.

所有這五個平台都是全新的，並且基於大量的體外和體內數據，看起來都是可行的。

During our last quarterly call, I described each of these five programs. In the interest of time, I'll focus on only two, our adoptive cell therapy and our cancer vaccine platforms, specifically what we believe will prove out to be their respective major advantages over our competitor programs.

在我們上一次季度電話會議中，我描述了這五個計劃中的每一個。由於時間關係，我將只關注兩個，即我們的過繼性細胞療法和我們的癌症疫苗平台，特別是我們相信將證明它們各自相對於我們的競爭對手項目的主要優勢。

Our adoptive cell therapy platform, or ACT, like our CAR-T platform is based on the novel identification of specific T cell signaling pathways, which once inhibited significantly and preferentially potentiate and enhance the expansion of tumor-specific memory T cells.

我們的過繼細胞治療平台（ACT）與我們的 CAR-T 平台一樣，基於對特定 T 細胞信號通路的新識別，該通路曾經顯著抑制並優先增強和增強腫瘤特異性記憶 T 細胞的擴增。

These tumor-specific memory T cells distinctively recognize and efficiently kill tumor cells. The potential advantages of our ACT platform over other cellular approaches are:

這些腫瘤特異性記憶 T 細胞能夠獨特地辨識並有效殺死腫瘤細胞。與其他細胞方法相比，我們的 ACT 平台的潛在優勢是：

One, rather than targeting just cell surface antigens, our ACT platform is designed to target both cell surface and intracellular cancer antigens, significantly broadening its range of indications.

第一，我們的 ACT 平台不只針對細胞表面抗原，而是針對細胞表面和細胞內癌症抗原而設計，顯著拓寬了其適應症範圍。

Two, instead of increasing predominantly either CD4 or CD8 T cells, both of which are needed to successfully kill the tumor, our ACT technology markedly increases levels of both CD4 and CD8 cancer-specific T cells.

第二，我們的 ACT 技術不是主要增加 CD4 或 CD8 T 細胞（這兩種細胞都是成功殺死腫瘤所必需的），而是顯著增加 CD4 和 CD8 癌症特異性 T 細胞的水平。

This should lead to more effective antitumor responses. In addition, the increase in memory cells is expected to mitigate the treatment exhaustion or the wearing off of the treatment effect seen with many currently available cellular therapies. This would result in the ability to treat the tumor repeatedly and prevent relapses.

這應該會導致更有效的抗腫瘤反應。此外，記憶細胞的增加預計將減輕治療耗盡或許多目前可用的細胞療法的治療效果的消失。這將導致能夠重複治療腫瘤並防止復發。

Unlike existing CAR-T therapies, our ACT technology does not require cellular engineering. Instead, cells from the patient are simply treated outside the body and administered through the patient. This would represent a major advance over currently available T cell therapies markedly decreasing both cost and preparation time.

與現有的 CAR-T 療法不同，我們的 ACT 技術不需要細胞工程。相反，來自患者的細胞只需在體外進行處理並透過患者進行給藥。這將代表目前可用的 T 細胞療法的重大進步，顯著降低成本和準備時間。

Together with enhanced efficacy by enabling multiple repetitive administrations, the expected result is better and sustained anti-tumor response.

加上透過多次重複給藥來提高療效，預期結果是更好且持續的抗腫瘤反應。

As with our other molecular I-O platforms, immunomodulators and immunotoxins, we're excited about the potential of our cancer vaccine platform as well and the potential for that platform to have a significant impact on the survival of cancer patients.

與我們的其他分子 I-O 平台、免疫調節劑和免疫毒素一樣，我們也對我們的癌症疫苗平台的潛力以及該平台對癌症患者的生存產生重大影響的潛力感到興奮。

Though widely pursued, successful development of therapeutic cancer vaccines remains difficult to achieve. Current approaches induce only transient and ineffective immune responses. We believe that we have discovered a way to overcome this challenge, generating novel molecules that combine tumor antigens with a potent adjuvant.

儘管得到廣泛追求，但治療性癌症疫苗的成功開發仍然難以實現。目前的方法僅誘導短暫且無效的免疫反應。我們相信，我們已經找到了克服這項挑戰的方法，產生將腫瘤抗原與有效佐劑結合的新型分子。

The biologic molecules activate antigen-presenting cells. This ultimately leads to efficient killing of tumor cells by both T cell and antibody-mediated activities. The vaccine also promotes a long-lasting immune response through the generation of memory T and B cells.

生物分子活化抗原呈現細胞。這最終導致 T 細胞和抗體介導的活性有效殺死腫瘤細胞。該疫苗還透過記憶 T 細胞和 B 細胞的生成促進持久的免疫反應。

The major advantages of our platform over other vaccine approaches are:

與其他疫苗方法相比，我們的平台的主要優勢是：

One, our platform should be applicable to all or nearly all tumors. And two, when injected into the body. Our novel biologic molecule should result not only in elimination of tumor cells, but importantly in immune memory against future cancer relapse. If needed, this immune memory could be further enhanced with subsequent vaccine boosters.

第一，我們的平台應該適用於所有或幾乎所有腫瘤。還有兩個，注射到體內時。我們的新型生物分子不僅可以消除腫瘤細胞，重要的是可以增強免疫記憶，防止未來癌症復發。如果需要，這種免疫記憶可以透過後續的疫苗加強劑進一步增強。

As I noted earlier today, the large majority of the efforts across our five novel cellular and molecular platforms are conducted in-house by a relatively small, but highly effective group of scientists.

正如我今天早些時候指出的，我們五個新穎的細胞和分子平台的大部分工作都是由相對較小但高效的科學家小組在內部進行的。

We believe that the moderate investment required to continue advancing our I-O program could create opportunities for meaningful non-dilutive funding.

我們相信，繼續推進 I-O 計劃所需的適度投資可以為有意義的非稀釋性融資創造機會。

So I'll now turn the call over to Mike Jacobsen, our Chief Accounting Officer, to go through a more detailed discussion of our third quarter financial results. Mike?

因此，我現在將把電話轉給我們的首席會計官邁克·雅各布森 (Mike Jacobsen)，以更詳細地討論我們第三季度的財務業績。麥克風？

Yeah, thanks, Greg. Our net loss for the third quarter was $37.8 million, or $0.60 per share compared to a net loss of $37.3 million or $0.59 per share in the second quarter of this year. Cash burn, as Greg mentioned, for the third quarter was $31 million.

是的，謝謝，格雷格。我們第三季的淨虧損為 3,780 萬美元，即每股 0.60 美元，而今年第二季的淨虧損為 3,730 萬美元，即每股 0.59 美元。正如格雷格所提到的，第三季的現金消耗為 3,100 萬美元。

As of September 30, 2023, we had $310 million of cash and investments on hand and $7 million in receivables, primarily consisting of OMIDRIA royalties. Cost and expenses from continuing operations for the third quarter were $48.2 million, an increase of $7.3 million from the second quarter of this year.

截至 2023 年 9 月 30 日，我們手頭上有 3.1 億美元的現金和投資，以及 700 萬美元的應收帳款，主要包括 OMIDRIA 特許權使用費。第三季持續營運成本和費用為 4,820 萬美元，比今年第二季增加了 730 萬美元。

The increase was primarily due to a licensing milestone payment made in connection with our OMS906 program and compensation expense. Interest expense for the third quarter was $7.9 million, consistent with the second quarter of this year.

這一增長主要是由於與我們的 OMS906 計劃相關的許可里程碑付款和補償費用。第三季利息支出為 790 萬美元，與今年第二季持平。

The primary drivers of interest expense are the 2023 and 2026 convertible notes and our OMIDRIA royalty obligation to DRI. our 2023 notes totaling $95 million are due next week. we plan on retiring the notes with a portion of our existing cash and investments.

利息支出的主要驅動因素是 2023 年和 2026 年可轉換票據以及我們對 DRI 的 OMIDRIA 特許權使用費義務。我們的 2023 年票據總額為 9,500 萬美元，將於下週到期。我們計劃用部分現有現金和投資來償還這些票據。

Now let's look at OMIDRIA royalties. Under our contract with Rayner, we are entitled to receive royalties on net sales of OMIDRIA for the duration of the relevant patent terms, which in the US now extend into 2035.

現在讓我們來看看 OMIDRIA 版稅。根據我們與 Rayner 的合同，我們有權在相關專利期限內收取 OMIDRIA 淨銷售額的特許權使用費，在美國，該期限現已延長至 2035 年。

Under the terms of the contract, the applicable royalty rate decreased from 50% to 30% of US net sales upon earning the $200 million milestone payment at the end of last year.

根據合約條款，在去年年底獲得 2 億美元里程碑付款後，適用的特許權使用費率從美國淨銷售額的 50% 降至 30%。

The 30% royalty rate will continue to apply while separate payment for OMIDRIA is in effect, and while sales of OMIDRIA have not been materially affected by the entry of a generic competitor.

在 OMIDRIA 的單獨付款生效期間，且 OMIDRIA 的銷售並未因仿製藥競爭對手的進入而受到重大影響時，30% 的特許權使用費率將繼續適用。

Under our settlement agreements with the generic manufacturers, we do not expect generic entry into the market until 2032 at the earliest, but should generic entry occur in 2032, any such generic would be at risk of infringing the recent issued patent that extends to 2035.

根據我們與仿製藥製造商的和解協議，我們預計仿製藥最早要到2032 年才能進入市場，但如果仿製藥在2032 年進入市場，任何此類仿製藥都將面臨侵犯最近頒發的專利的風險，該專利的有效期限可延長至2035 年。

As previously mentioned, separate payment for OMIDRIA will continue under statutory mandate until at least January 2028.

如前所述，OMIDRIA 的單獨付款將根據法定授權繼續至少持續到 2028 年 1 月。

For the third quarter, our royalties on OMIDRIA net sales were $10 million, down $700,000 from the second quarter. This is consistent with the historical decline in cataract procedures during the summer months. Royalties earned are recorded as a reduction in the OMIDRIA contract royalty asset on our balance sheet.

第三季度，我們對 OMIDRIA 淨銷售額的特許權使用費為 1,000 萬美元，比第二季度減少了 70 萬美元。這與夏季白內障手術的歷史下降是一致的。所賺取的特許權使用費在我們的資產負債表上記錄為 OMIDRIA 合約特許權使用費資產的減少。

Income from discontinued operations in the third quarter was $13.9 million and includes two primary components, $3.7 million of interest earned on the OMIDRIA contract royalty asset and $10.1 million of income due to remeasurement adjustments on our OMIDRIA contract royalty asset. The measurement adjustment reflects expected incremental OMIDRIA net sales during the patent term.

第三季來自已終止業務的收入為1390 萬美元，包括兩個主要組成部分：OMIDRIA 合約特許權使用費資產賺取的370 萬美元利息和由於OMIDRIA 合約特許權使用費資產重新計量調整而產生的1010 萬美元收入。計量調整反映了專利期限內 OMIDRIA 淨銷售額的預期增量。

Now let's take a look at our expectations for the fourth quarter. During the fourth quarter, we will incur various costs to close out the ARTEMIS-IGAN trial.

現在讓我們來看看我們對第四季的預期。在第四季度，我們將產生各種費用來結束 ARTEMIS-IGAN 試驗。

Additionally, we expect our manufacturing spend on OMS906 will increase as will our cost for the OMS1029 clinical trials. These increases are offset by the OMS906 development milestone we incurred in the third quarter.

此外，我們預期 OMS906 的製造支出將會增加，OMS1029 臨床試驗的成本也會增加。這些成長被我們第三季實現的 OMS906 開​​發里程碑所抵消。

Overall, we expect fourth quarter R&D costs to be similar to the second quarter just completed. Fourth quarter SG&A costs should be consistent with historical levels, with spending in the $12 million range.

總體而言，我們預計第四季度的研發成本將與剛完成的第二季相似。第四季的 SG&A 成本應與歷史水準一致，支出在 1,200 萬美元範圍內。

Interest income in the fourth quarter should be approximately $2.5 million. The decrease from the third quarter reflects the use of $95 million of cash to retire the 2023 notes.

第四季的利息收入約為250萬美元。較第三季減少的原因是使用了 9,500 萬美元現金來償還 2023 年票據。

Interest expense for Q4 will be approximately $7 million, down $900,000 from the third quarter due to the November 15 retirement of the 2023 notes. Income from discontinued operations for the fourth quarter should be approximately $6 million.

由於 2023 年票據將於 11 月 15 日退役，第四季的利息支出約為 700 萬美元，比第三季減少 90 萬美元。第四季來自已終止業務的收入應約為 600 萬美元。

With that, I'll turn the call back over to Greg. Greg?

這樣，我會將電話轉回給格雷格。格雷格？

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

謝謝，麥克。接線員，讓我們開始提問。

(Operator Instructions) Steve Brozak, WBB Securities.

（操作員指令）Steve Brozak，WBB 證券。

Hey. Good afternoon and thank you for taking questions. There's a word that keeps coming up, compassionate use. And you've mentioned it a couple of times, obviously, in the number of patients you've been treating, but also as far as in the ASH document that is being published. Can you go into as much detail as is possible on that, please?

嘿。下午好，感謝您提出問題。有一個字不斷出現，就是慈悲使用。顯然，您已經在您治療的患者數量中多次提到這一點，而且在正在發布的 ASH 文件中也提到過這一點。您能盡可能詳細地介紹一下嗎？

Hi, Steve. Sure. We went through, I think, the data from that compassionate-use abstract during the prepared comments, but I can summarize those for you. These were 15 compassionate-use patients. They were adult and children, 14 of them were high risk.

嗨，史蒂夫。當然。我認為，我們在準備評論期間瀏覽了同情使用摘要中的數據，但我可以為您總結這些數據。這些是 15 名同情使用的患者。其中有成人和兒童，其中14人為高危險群。

When we looked or when those investigators looked at those patients, the response rate was high. The 100-day survival across the study was 80%. So that's all patients in the study, including non-responders.

當我們觀察或當那些研究人員觀察這些患者時，反應率很高。整個研究的 100 天存活率為 80%。這就是研究中的所有患者，包括無反應者。

And when you look only at responders, the survival rate was 100%. So again, similar to what we had seen in our pivotal trial. And we think, again, consistent and clearly underscoring, the role of lectin pathway inhibition in this disease.

當你只看回應者時，存活率為 100%。再說一遍，與我們在關鍵試驗中看到的情況類似。我們認為，再次一致且明確地強調了凝集素途徑抑制在這種疾病中的作用。

We have, as we mentioned, over 120 patients that we have treated with compassionate-use narsoplimab. Many of those are from sites that have put in multiple requests.

正如我們所提到的，我們已經用富有同情心的 narsoplimab 治療了 120 多名患者。其中許多來自提出多個請求的網站。

So if you're getting multiple requests from a large number of sites, you would expect that those sites are having success with the treatment, otherwise, I would expect you would not receive multiple requests.

因此，如果您從大量網站收到多個請求，您會期望這些網站能夠成功處理，否則，我希望您不會收到多個請求。

Further, to that point, you have to think about the patients for whom compassionate-use narsoplimab is being requested. These are, for the most part, obviously, very sick patients.

此外，在這一點上，您必須考慮需要同情使用 narsoplimab 的患者。顯然，這些患者大部分都是病得很重的病人。

They may be patients, or in the case of a good number of these, they are patients who have failed prior treatments either with eculizumab, ravulizumab, defibrotide, pegcetacoplan. And we are being asked effectively to catch a falling knife. We do not deny treatment. We tried to get the treatment there as quickly as possible.

他們可能是患者，或者在其中許多人的情況下，他們是先前使用依庫珠單抗、拉維珠單抗、去纖苷、培西他普蘭治療失敗的患者。我們被要求有效地接住掉落的刀子。我們並不否認治療。我們試圖盡快在那裡接受治療。

So I think the results are even more impressive given what we would expect to be the severity of the patients and the fact that a good number of them have failed prior treatment with other off-label drugs, and then we see this response with narsoplimab. That, I guess you could explain that.

因此，考慮到我們預期患者的嚴重程度以及其中許多患者之前使用其他適應證外藥物治療失敗的事實，我認為結果更加令人印象深刻，然後我們看到了 narsoplimab 的這種反應。那，我想你可以解釋一下。

If it happened once, it could be just chance, two, may be an act of God. But at some point, the number of those patients responding to narsoplimab, I think, really point to what the drug is doing to help these patients.

如果發生一次，可能只是偶然，兩次，可能是天災。但在某種程度上，我認為對 narsoplimab 做出反應的患者數量確實表明了該藥物正在為這些患者提供幫助。

And that's why we genuinely believe it's important that we make it available. It is at our cost and that cost is substantial. So we want to continue to do it throughout the regulatory process. But at some point, it really does become, I think, untenable. But we try to do what we can here.

這就是為什麼我們真誠地相信提供它很重要。這是我們付出的代價，而且代價是巨大的。所以我們希望在整個監管過程中繼續這樣做。但在某些時候，我認為它確實變得站不住腳。但我們在這裡盡我們所能。

Just along those lines, and I'll hop back in the queue. Thank you. The clinicians, because you're mentioning these patients that are obviously in critical states.

沿著這些思路，我會跳回隊列。謝謝。臨床醫生，因為你提到了這些顯然處於危急狀態的患者。

The clinicians, what are -- I'm sure that these are the people that have been convinced. So what feedback are you getting from them? And I'll hop back in the queue. Thank you.

臨床醫生，我確信這些人已經被說服了。那麼您從他們那裡得到什麼回饋？我會跳回到隊列中。謝謝。

Yeah, it's a good question. Clearly, we're receiving positive feedback from them, and that feedback is not only coming to us, it's being put into abstracts and potentially, publications or already published on these patients and their responses.

是的，這是一個好問題。顯然，我們正在從他們那裡收到積極的回饋，而這些回饋不僅會傳給我們，還會被寫入摘要中，並可能被發表或已經發表有關這些患者及其反應的文章。

So this is what we're -- this is what we're seeing, and this is -- it's all consistent, I guess, would be my point. And I think if you look at the data, I think those are pretty clear.

這就是我們所看到的，這就是我們所看到的，我想這就是我的觀點，這一切都是一致的。我認為如果你看一下數據，我認為這些非常清楚。

Serge Belanger, Needham.

塞爾吉·貝蘭格，李約瑟。

Good afternoon. Just one question for us. On HSCT-TMA, what kind of feedback are you expecting from FDA regarding the analysis plan? And is this something that could drag out beyond year end this year?

午安.只需要問我們一個問題。關於 HSCT-TMA，您希望 FDA 就分析計畫提供什麼樣的回饋？這是否會拖到今年年底之後？

Yeah. Hi, Serge. Look, I think, clearly, what we hope to receive from FDA is acknowledgment and alignment on the statistical analysis plan that's been submitted.

是的。嗨，塞爾吉。我認為，顯然，我們希望從 FDA 得到的是對已提交的統計分析計劃的認可和調整。

As I stated earlier, this analysis plan has been put together not by Omeros but by an external and very well-respected, well-known bio statistical group. We believe that it is frankly conservative. We think it should be acceptable.

正如我之前所說，這個分析計畫不是由 Omeros 制定的，而是由外部的、備受尊敬的知名生物統計小組制定的。我們認為，坦白說，這是保守的。我們認為這應該是可以接受的。

So what we are hoping to hear back in the near term is that the approach that has been proposed is acceptable. We can go ahead and run the analyses which have not yet been run. And based on the outcome of those analyses, if those analyses are supportive of a BLA, we will resubmit the BLA.

因此，我們希望在短期內聽到的答覆是，所提出的方法是可以接受的。我們可以繼續運行尚未運行的分析。根據這些分析的結果，如果這些分析支持 BLA，我們將重新提交 BLA。

So with respect to timing, I think what we have guided to is what we continue to hold to and drive to, which is, we are really pushing to get an FDA response on a resubmitted BLA in mid next year, which would be followed very shortly thereafter by the commercial launch of narsoplimab for TA-TMA.

因此，就時間安排而言，我認為我們所指導的是我們繼續堅持和推動的，也就是說，我們確實正在努力爭取 FDA 在明年中期重新提交的 BLA 得到答复，隨後將非常跟進。此後不久，針對TA-TMA 的narsoplimab 商業化上市。

Did that answer your question? Cathy, do you want to add anything to that, or Andreas, or Steve?

這回答了你的問題嗎？凱西（Cathy）、安德烈亞斯（Andreas）或史蒂夫（Steve）想補充什麼嗎？

Sure, Greg. (multiple speakers)

當然，格雷格。 （多個發言者）

Sorry, go ahead.

抱歉，請繼續。

No. Go ahead, Serge. Ask and then I'll --

不，繼續吧，塞爾日。詢問然後我會——

All right. I was just saying, so refiling, it's still pending analysis of the data. That hasn't been completed at this point.

好的。我只是說，所以重新提交，還有待數據分析。目前尚未完成。

Sure. We have not analyzed the data. We have built the analysis plan, or I should say, our external biostatisticians have built the analysis plan, but we are waiting to get alignment with FDA so that we can analyze those data. And it is then done without foreknowledge of the outcome. That has been -- that's been our approach. We think it's the right approach.

當然。我們還沒有分析數據。我們已經制定了分析計劃，或者我應該說，我們的外部生物統計學家已經制定了分析計劃，但我們正在等待與 FDA 保持一致，以便我們可以分析這些數據。然後在不預先知道結果的情況下完成它。這就是我們的做法。我們認為這是正確的做法。

Frankly, the analysis -- after having built the programs, that analysis should take one to two days to complete. So that's not going to be a -- any kind of meaningful time delay in moving forward.

坦白說，分析——在建立程式之後，該分析應該需要一到兩天才能完成。因此，這不會對前進造成任何有意義的時間延遲。

But Cathy, do you want to add to that?

但是凱西，你想補充一下嗎？

Sure. I think you had asked about what feedback we expect, that sort of thing, and the plan that we've put together, the proposal is consistent with the feedback that we received not just from the Office of New Drugs but following the meeting that we had with the review division in the summer.

當然。我想你已經問過我們期望什麼反饋，諸如此類的事情，以及我們制定的計劃，該提案與我們不僅從新藥辦公室收到的反饋一致，而且與我們在會議之後收到的反饋一致。夏天與審查部門進行了合作。

And also, as you may know, FDA has come out with a lot of recent guidance documents on use of external control groups and real-world data, and our proposal is consistent with all of those things. So we feel confident in what we've proposed to FDA, and we await their response.

而且，如您所知，FDA 最近發布了許多關於使用外部對照組和真實世界數據的指導文件，我們的提案與所有這些內容都是一致的。因此，我們對向 FDA 提出的建議充滿信心，並等待他們的回應。

Thanks, Cathy.

謝謝，凱茜。

I appreciate this clarity.

我很欣賞這種清晰度。

All right. Thank you. Andreas, anything you want to add to that.

好的。謝謝。安德烈亞斯，你想補充什麼。

No. I think that sums it up and we're awaiting FDA feedback and are excited to interact with them on this.

不。我認為這就是總結，我們正在等待 FDA 的反饋，並很高興與他們就此進行互動。

Steve Brozak, WBB Securities.

史蒂夫·布羅扎克 (Steve Brozak)，WBB 證券公司。

Hey. Thanks again for taking the follow-up. The question just -- ask in terms of your plan as far as following up on the statistical review. But just to go over, everything you've got in terms of other items in the submission, CMC and everything else, those you have and have prepared concurrently.

嘿。再次感謝您的關注。問題只是——根據你的計劃詢問統計審查的後續情況。但只是回顧一下，您在提交的其他項目、CMC 和其他所有項目方面所擁有的所有內容，以及您同時擁有和準備的內容。

So there would be no delay by anything that you would see with that. And just to go over it, that -- you would be basically looking at that as something that would frankly be already accomplished, is that correct as well?

因此，您所看到的任何事情都不會延遲。回顧一下，你基本上會認為這是坦率地已經完成的事情，這也是正確的嗎？

We have been in the process of assembling all of the information that we plan to include in the resubmission. So in direct answer to your question, none of those should represent any kind of delay.

我們一直在收集計劃包含在重新提交中的所有資訊。因此，在直接回答你的問題時，這些都不應該代表任何形式的延遲。

So again, as Cathy pointed out, everything that we built in or was built into the analysis plan is really consistent with the guidance we've received not only from the division, not only from the Office of New Drugs where, you recall, we had appealed the initial CRL, but also with the guidance documents set forth by FDA in the recent past.

因此，正如 Cathy 指出的那樣，我們在分析計劃中內置或內置的所有內容都與我們不僅從該部門、不僅從新藥辦公室收到的指導一致，您還記得，我們​​在新藥辦公室收到了指導嗎？已對最初的CRL 提出上訴，但也對FDA 最近制定的指導文件進行了上訴。

So we think we have done what we need to do. The pieces of the BLA are coming together now. We don't want to delay. So we don't see any of those other components resulting in a delay.

所以我們認為我們已經做了我們需要做的事情。 BLA 的各個部分現在正在整合。我們不想拖延。因此，我們沒有看到任何其他組件導致延遲。

Thank you so much. And there are no further questions at this time. I would now like to turn the conference back to Dr. Demopulos for his closing remarks.

太感謝了。目前沒有其他問題。現在我想請德普洛斯博士致閉幕詞。

All right. Thank you. Thank you, operator, and thank you all for joining this afternoon. Everyone at Omeros is working hard to recover, sustain, and ultimately grow value for our shareholders following the ARTEMIS-IGAN results.

好的。謝謝。謝謝接線生，也謝謝大家今天下午的加入。在 ARTEMIS-IGAN 結果公佈後，Omeros 的每個人都在努力為我們的股東恢復、維持並最終增加價值。

I hope that today's presentation helped to identify the opportunities for value creation across our late-stage and even our earlier-stage programs.

我希望今天的演講有助於確定我們後期甚至早期專案中創造價值的機會。

I remember for those of you who have or can obtain access to ASH either in person or remotely, the Phase 2 clinical update on OMS906 program will be presented by Dr. Jens Panse on Sunday, December 10 at 5:00 PM Pacific Time.

我記得對於那些已經或能夠親自或遠端存取 ASH 的人來說，Jens Panse 博士將於太平洋時間 12 月 10 日星期日下午 5:00 介紹 OMS906 計畫的 2 期臨床更新。

The presentation will provide a good sense of where our MASP-3 alternative pathway inhibitor program stands relative to other alternative pathway inhibitor programs.

該演示將讓人們很好地了解我們的 MASP-3 替代途徑抑制劑計劃相對於其他替代途徑抑制劑計劃的地位。

As underscored today, we believe that we control the premier target in MASP-3 in the premier drug and OMS906 in the alternative pathway space.

正如今天所強調的，我們相信我們控制著主要藥物中的 MASP-3 和替代途徑領域中的 OMS906 的主要標靶。

The other two ASH abstracts on our programs, one detailing the outcomes of the high-risk TA-TMA patients treated with narsoplimab under compassionate use that we were just discussing and the other describing the mechanistic support for MASP-3 inhibition in PNH, those both will be presented on Sunday, December 10, and then Monday, December 11, respectively.

我們計畫的另外兩篇ASH 摘要，一篇詳細介紹了我們剛剛討論的在富有同情心的情況下接受narsoplimab 治療的高風險TA-TMA 患者的結果，另一篇描述了PNH 中MASP-3 抑制的機制支持，這兩個摘要分別將於 12 月 10 日星期日和 12 月 11 日星期一舉行。

The time slot for both is 6:00 PM to 8:00 PM Pacific Time. Details of all presentations can be found in our press releases issued on November 2 and on November 3.

兩者的時間段均為太平洋時間下午 6:00 至晚上 8:00。所有演示的詳細資訊可以在我們 11 月 2 日和 11 月 3 日發布的新聞稿中找到。

So with that, thanks again, and as always, we appreciate your continued support. Have a good day. Thank you.

因此，再次感謝您，並一如既往地感謝您的持續支持。祝你有美好的一天。謝謝。

Thank you for your attention. And that concludes today's conference call. Thank you for participating, and you may now disconnect. Have a good day.

感謝您的關注。今天的電話會議到此結束。感謝您的參與，您現在可以斷開連接。祝你有美好的一天。