SeaStar Medical Holding Corp (ICU) 2025 Q1 法說會逐字稿

Hello and thank you for standing by. My name is Tiffany, and I will be your conference operator today. At this time, I would like to welcome everyone to the SeaStar Medical first-quarter financial results conference call. (Operator Instructions)

您好，感謝您的支持。我叫蒂芬妮，今天我將擔任您的會議主持人。現在，我歡迎大家參加 SeaStar Medical 第一季財務業績電話會議。（操作員指示）

Thank you. I would now like to turn the call over to Jackie Cosman. Please go ahead.

謝謝。現在我想把電話轉給 Jackie Cosman。請繼續。

Thank you, Tiffany. Good afternoon and thank you for joining the Sea Star Medical first-quarter 2025 financial results conference call. I'm Jackie Cosman, Wheelhouse Life Science Advisors. Joining me today from Seastar Medical are Eric Schlorff, Chief Executive Officer; David Green, Chief Financial Officer; Dr. Kevin Chung, Chief Medical Officer, and Tim Varacek, Senior Vice President of Commercial and Business Operations.

謝謝你，蒂芙尼。下午好，感謝您參加 Sea Star Medical 2025 年第一季財務業績電話會議。我是 Wheelhouse 生命科學顧問公司的 Jackie Cosman。今天與我一起出席的還有 Seastar Medical 的執行長 Eric Sc​​hlorff、財務長 David Green、首席醫療官 Kevin Chung 博士和商業和業務營運高級副總裁 Tim Varacek。

I would like to remind listeners that comments made during this call by management will include forward-looking statements within the meaning of the federal securities laws. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from any anticipated results.

我想提醒聽眾，管理階層在本次電話會議中發表的評論將包括聯邦證券法所定義的前瞻性陳述。這些前瞻性陳述涉及風險和不確定性，可能導致實際結果與預期結果有重大差異。

For a list and description of these risks and uncertainties, please review SeaStar Medical's filings with the Securities and Exchange Commission. Furthermore, the content of this call contains information that is accurate only as of the date of the live broadcast, May 14, 2025. SeaStar Medical undertakes no obligation to revise or update any statements to reflect events or circumstances except as required by law.

有關這些風險和不確定性的清單和描述，請查看 SeaStar Medical 向美國證券交易委員會提交的文件。此外，本次通話內容所包含的資訊僅截至直播日期 2025 年 5 月 14 日是準確的。除非法律要求，否則 SeaStar Medical 不承擔修改或更新任何聲明以反映事件或情況的義務。

And now I'd like to turn the call over to Eric. Eric?

現在我想把電話轉給艾瑞克。艾瑞克？

Yeah, thank you, Jackie, and thank you all for joining us today. We have made great progress on several fronts. Just last week we added another prestigious nationally recognized children's hospital to our list of QUELIMMUNE customers and achieved 50% enrollment in our NEUTRALIZE-AKI trial. We were granted two new breakthrough device designations by the FDA, expanding our pipeline indications to address the destructive hyperinflammation that can occur during adult and pediatric cardiac surgery.

是的，謝謝你，Jackie，也謝謝大家今天加入我們。我們在多個方面取得了巨大進展。就在上週，我們在 QUELIMMUNE 客戶名單中又增加了一家享有盛譽的全國性兒童醫院，並且在我們的 NEUTRALIZE-AKI 試驗中實現了 50% 的入組率。我們獲得了 FDA 授予的兩項新的突破性設備稱號，擴大了我們的產品線適應症，以解決成人和兒童心臟手術期間可能出現的破壞性過度發炎。

We are especially pleased to see the increased adoption of our QUELIMMUNE therapy in our existing customer sites. This drove a four-fold increase in our first-quarter revenue compared to the fourth quarter of 2024. Tim will discuss our QUELIMMUNE commercialization strategy shortly, but let me just reiterate that our primary goal this year is to grow our customer base.

我們特別高興地看到，我們現有的客戶站點越來越多地採用我們的 QUELIMMUNE 療法。這使得我們的第一季營收與 2024 年第四季相比成長了四倍。提姆很快就會討論我們的 QUELIMMUNE 商業化策略，但我只想重申，我們今年的主要目標是擴大我們的客戶群。

We are clearly seeing that once adopted, customers are experiencing organ sparing and life-saving outcomes from using the QUELIMMUNE therapy in their pediatric AKI patients. As we grow our customer base, we believe we can drive meaningful revenue from this small but important market of about 4,000 patients annually in the United States.

我們清楚地看到，一旦採用 QUELIMMUNE 療法，客戶就會透過在兒科 AKI 患者身上使用 QUELIMMUNE 療法來獲得器官保留和挽救生命的結果。隨著客戶群的不斷擴大，我們相信我們可以從這個每年約有 4,000 名患者的美國小而重要的市場中獲得可觀的收入。

Now turning to what we believe is a significant upside opportunity for SeaStar Medical, I'd like to talk about the adult AKI market as well as the other opportunities for the SCD therapy. Our clinical development is now focused on penetrating the adult markets. It's important to note that our SCD therapy is designed as a diseasemodifying therapy that neutralizes overactive immune cells and stops the destructive hyperinflammation that shuts down critical organ function and takes lives.

現在談談我們認為對 SeaStar Medical 來說是一個重大的上升機會，我想談談成人 AKI 市場以及 SCD 療法的其他機會。我們的臨床開發目前專注於滲透成人市場。值得注意的是，我們的 SCD 療法旨在作為疾病改良療法，可中和過度活躍的免疫細胞並阻止破壞性過度炎症，從而阻止關鍵器官功能關閉並奪走生命。

An extreme example of this was COVID-19, but every year, millions of patients experience surgery, trauma, or infection where their body's immune system overreacts and the cytokine storm yields destructive hyperinflammation and creates a cascade of events that wreak havoc in the patient's body.

一個極端的例子是 COVID-19，但每年都有數百萬患者經歷手術、創傷或感染，他們身體的免疫系統反應過度，細胞激素風暴產生破壞性的過度炎症，並引發一系列事件，對患者的身體造成嚴重破壞。

Our first opportunity in the adult patient population is for the treatment of hyperinflammation in patients with acute kidney injury or AKI requiring continuous renal replacement therapy or CRRT. This is a similar condition to pediatric AKI that is life threatening with no effective treatment options, but it is a far larger market opportunity with over 200,000 adults, or 50 times the number of pediatric patients with this condition. Based on our current estimates, this translates to about a $4.5 billion total annual market opportunity in the United States.

我們在成年患者群體中的第一個機會是治療需要持續腎臟替代治療或 CRRT 的急性腎損傷或 AKI 患者的過度發炎。這是一種與兒童 AKI 類似的疾病，具有生命危險，且沒有有效的治療方法，但它的市場機會要大得多，有超過 20 萬名成年人患有這種疾病，是兒童患者數量的 50 倍。根據我們目前的估計，這意味著美國每年的市場總價值約為 45 億美元。

Our NEUTRALIZE-AKI pivotal trial for adult patients with AKI and CRT is well underway, and if all goes to plan, we intend to file a PMA for this indication in 2026. We announced yesterday that our ongoing NEUTRALIZE-AKI trial has reached a 50% enrollment target. This enrollment milestone also triggered the pre-specified interim analysis by the trial's Independent Data Safety Monitoring Board, or DSMB. I'll let Kevin describe the details, but the interim analysis is designed to evaluate the safety and powering assumptions for the trial.

我們針對患有 AKI 和 CRT 的成年患者進行的 NEUTRALIZE-AKI 關鍵試驗正在順利進行，如果一切按計劃進行，我們打算在 2026 年針對該適應症提交 PMA。我們昨天宣布，我們正在進行的 NEUTRALIZE-AKI 試驗已達到 50% 的入組目標。這項招募里程碑也觸發了試驗獨立資料安全監測委員會 (DSMB) 預先指定的中期分析。我會讓凱文描述細節，但中期分析旨在評估試驗的安全性和動力假設。

We anticipate that the DSMB will report its findings to the company in the third quarter of 2025. I would like to emphasize here that in order to maintain the integrity of the trial, specific data from the internet analysis cannot be shared. We will, however, issue a press release to provide the DSMB's final recommendation.

我們預計 DSMB 將於 2025 年第三季向該公司報告其調查​​結果。我想在這裡強調，為了維護試驗的完整性，網路分析的具體數據不能分享。不過，我們將發布一份新聞稿，提供 DSMB 的最終建議。

Completing the NEUTRALIZE-AKI trial and potentially obtaining approval are key near term milestones for us. We are very excited about this market opportunity and are already engaging with physicians and healthcare providers on the medical affairs side to educate them about the SCD therapy and data that support its use as a potential treatment for patients with AKI and CRT.

完成 NEUTRALIZE-AKI 試驗並可能獲得批准是我們近期的關鍵里程碑。我們對這個市場機會感到非常興奮，並且已經與醫療事務方面的醫生和醫療保健提供者合作，向他們介紹 SCD 療法以及支持將其用作 AKI 和 CRT 患者潛在治療方法的數據。

Beyond the AKI market, the SCD therapy has been granted breakthrough device designations for five other indications. Tim will describe the potential commercial opportunities that we hope to derive from our rich pipeline of indications.

除了 AKI 市場之外，SCD 療法還被授予其他五種適應症的突破性設備稱號。蒂姆將描述我們希望從豐富的適應症管道中獲得的潛在商業機會。

And with that as an overview, I'll turn the call over to Tim to discuss our commercial achievements and market opportunities.

以此作為概述，我將把電話轉給蒂姆，討論我們的商業成就和市場機會。

Thanks, Eric, and thanks everyone for joining us on the SeaStar Medical call. We're thrilled to report the solid increase in revenue in this first quarter, and what's most important to us are the metrics underlying the increase. We continue to see repeat orders at our existing sites as physicians gain more confidence treating pediatric patients based on their treatment experience with quality immune therapy.

謝謝，埃里克，也感謝大家參加 SeaStar Medical 電話會議。我們很高興地報告第一季營收穩定成長，對我們來說最重要的是成長背後的指標。隨著醫生根據其使用優質免疫療法的治療經驗對治療兒科患者越來越有信心，我們現有的診所繼續收到重複訂單。

In addition to the two new customers that we announced earlier this year, we reported today that we have shipped quality therapy to another new customer that is a nationally recognized children's medical facility. Our pipeline of potential customers is expanding, and we anticipate bringing on new multiple sites by year end.

除了我們今年稍早宣布的兩個新客戶之外，我們今天還報告說，我們已經向另一個新客戶運送了優質治療藥物，這是全國知名的兒童醫療機構。我們的潛在客戶管道正在擴大，我們預計到年底將引入多個新站點。

QUELIMMUNE is the only FDA-approved product for the condition of life-threatening acute kidney injury due to sepsis or septic-like condition in critically ill pediatric patients. The data show that these young patients have a 50% chance of survival, and in many cases that we've seen, it's less than that.

QUELIMMUNE 是唯一獲得 FDA 批准的用於治療危重兒科患者因敗血症或類似敗血症而出現的危及生命的急性腎損傷的產品。數據顯示，這些年輕患者的生存機會為50%，而在我們看到的許多病例中，生存機會甚至低於這個數字。

If they survive, a significant portion also experience lifelong organ damage and require outpatient renal replacement therapy 2 to 3 times per week. This is also known as dialysis. Our QUELIMMUNE clinical trials shows significant improvement in these outcomes, so we believe that over time, we can capture a healthy portion of what we estimate to be about $100 million total annual US market opportunity based on a pediatric AKI population of approximately 4,000 patients.

即使他們存活下來，很大一部分患者也會遭受終生器官損傷，並且需要每週 2 至 3 次門診腎臟替代治療。這也稱為透析。我們的 QUELIMMUNE 臨床試驗表明這些結果有顯著改善，因此我們相信，隨著時間的推移，我們可以抓住基於約 4,000 名兒科 AKI 患者群體估計的每年約 1 億美元的美國市場機會中的很大一部分。

Now with respect to our overall commercial strategy and current plans, our primary goal is site adoptions. Our specific focus today is on select children's medical facilities that typically treat a higher volume of these pediatric AKI patients. And to put this into perspective, this is a very concentrated market, and our objective is to focus on the top 50 pediatric sites in the US that have the resources to support this registry.

現在就我們的整體商業策略和當前計劃而言，我們的主要目標是站點採用。我們今天特別關注的是那些通常治療大量兒童 AKI 患者的精選兒童醫療機構。從這個角度來看，這是一個非常集中的市場，我們的目標是關注美國前 50 個擁有資源來支持該登記處的兒科站點。

As we've said previously, the process of adoption at these medical centers can be lengthy for any new device, and for QUELIMMUNE, the FDA approval requires a post-approval surveillance registry that adds an additional step and requires an additional IRB approval of this registry. That typically takes more time and that boils down to time to activation, which can vary from several months to approximately eight months.

正如我們之前所說，任何新設備在這些醫療中心的採用過程都可能很漫長，而對於 QUELIMMUNE，FDA 批准需要進行批准後監測註冊，這增加了額外的步驟，並且需要 IRB 對該註冊進行額外的批准。這通常需要更多時間，也就是啟動時間，可能從幾個月到大約八個月不等。

The good news is that we're engaged with most of the top pediatric medical centers in the US And they are truly interested in bringing QUELIMMUNE into their facilities. We see a strong commitment in terms of championing this effort by the pediatric nephrology and ICU teams as we go through the adoption process with them. Our internal tracking date indicates that 7 out of every 10 pediatric hospitals we approach to gauge interest ultimately commit to call immune therapy adoption.

好消息是，我們與美國大多數頂級兒科醫療中心都有合作，他們確實有興趣將 QUELIMMUNE 引入他們的醫療機構。在我們與兒科腎臟病學和 ICU 團隊一起完成採用過程的過程中，我們看到了他們對支持這項工作的堅定承諾。我們的內部追蹤數據表明，我們聯繫的每 10 家兒科醫院中，有 7 家最終承諾採用免疫療法。

And we still anticipate that sales will be lumpy until more pediatric hospitals are activated, and we can gain a further understanding of the cadence of patient presentation within these hospitals. But the excitement for the outcomes that QUELIMMUNE therapy can deliver is growing in the pediatric community, and word of mouth is the best validation for expanding QUELIMMUNE adoption. So with that framework of our QUELIMMUNE launch efforts, I'll now discuss our commercial opportunity for the SCD therapy platform.

我們仍然預計，在更多的兒科醫院投入營運之前，銷售額將會不穩定，我們可以進一步了解這些醫院內病患就診的節奏。但是，兒科界對於 QUELIMMUNE 療法所能帶來的療效的興奮感正在不斷增長，而口碑是擴大 QUELIMMUNE 採用的最佳驗證。因此，在我們的 QUELIMMUNE 啟動工作的框架下，我現在將討論 SCD 治療平台的商業機會。

With our NEUTRALIZE-AKI trial well underway, we have begun our pre-commercialization efforts to support a potential loss -- launch of the SCD therapy as a treatment for adult patients with AKI requiring CRRT. Our current anticipated launch timeline in adult AKI is Q4 of 2026, and this assumes positive clinical trial results and FDA approval.

隨著 NEUTRALIZE-AKI 試驗的順利進行，我們已經開始了商業化前的努力，以支持潛在的損失——推出 SCD 療法作為需要 CRRT 的成年 AKI 患者的治療方法。我們目前預計成人 AKI 的上市時間表是 2026 年第四季度，這假設臨床試驗結果積極並獲得 FDA 批准。

The total market opportunity in the US is approximately 50 times the size of the pediatric population, or about 200,000 patients annually, that face organ failure and potentially loss of life with no FDA approved treatment options beyond the current standard of care, which is CRRT and antibiotics.

美國的總市場機會約為兒科人口規模的 50 倍，即每年約有 20 萬名患者面臨器官衰竭並可能失去生命，除了目前的標準治療方法（即 CRRT 和抗生素）之外，沒有 FDA 批准的治療選擇。

At our current projected revenue per patient, this translates to a total market opportunity of about [$4.5 billion]. Even a modest market penetration would deliver significant revenue for SeaStar Medical. For this near-term potential market, we are also modeling a more favorable time to adoption than QUELIMMUNE based on factors such as increased clinical need due to the size of this population, as well as our ability to leverage pediatric customer experiences with QUELIMMUNE.

根據我們目前預測的每位患者收入，這意味著總市場機會約為[45億美元]。即使市場滲透率不高，也能為 SeaStar Medical 帶來可觀的收入。對於這個近期潛在市場，我們還根據諸如由於該人群規模而導致的臨床需求增加以及我們利用 QUELIMMUNE 的兒科客戶體驗的能力等因素，模擬了比 QUELIMMUNE 更有利的採用時機。

Kevin and the medical affairs team are already in the process of educational efforts in the peer-to-peer setting, and we are excited about the prospects of adding this potential life-saving therapy for adult patients with AKI and CRRT.

Kevin 和醫療事務團隊已經在點對點環境中開展教育工作，我們對為患有 AKI 和 CRRT 的成年患者添加這種潛在的救命療法的前景感到興奮。

And now turning to the broader market. The adult AKI indication is just the beginning of a long line of indications that could follow. When looking at just the indications in which we have received FDA breakthrough device designation, we estimate in the US market alone, the total annual market size is hundreds of thousands of patients that currently have no approved therapies to address conditions where destructive hyperinflammation creates critical care issues, organ failure, and death.

現在轉向更廣闊的市場。成人 AKI 適應症只是後續一系列適應症的開始。如果只看我們獲得 FDA 突破性設備認證的適應症，我們估計僅在美國市場，每年的總市場規模就高達數十萬患者，這些患者目前沒有獲得批准的治療方法來解決破壞性過度炎症造成危重護理問題、器官衰竭和死亡的情況。

At SeaStar Medical, we are committed to bringing our first and only SCD therapy to patients who today face lifelong organ damage and loss of life.

在 SeaStar Medical，我們致力於為當今面臨終身器官損傷和生命損失的患者提供我們的第一個也是唯一一個 SCD 療法。

And with that, I'll turn the presentation over to our Chief Medical Officer, Kevin Chung. Kevin?

接下來，我將把演講交給我們的首席醫療官 Kevin Chung。凱文？

Thanks, Tim, and thanks to our listeners for joining us today. I am pleased to report that our NEUTRALIZE-AKI trial has not crossed the halfway point towards our enrollment goal of 200 patients. We currently stand at 100 patients enrolled as of Tuesday.

謝謝，提姆，也感謝我們的聽眾今天加入我們。我很高興地報告，我們的 NEUTRALIZE-AKI 試驗尚未完成招募 200 名患者的目標的一半。截至週二，我們目前已登記 100 名患者。

NEUTRALIZE-AKI, as many of you know, is our randomized controlled pivotal trial designed to determine whether up to 10 sequential 24-hour treatments with SCD therapy will improve 90-day survival or recovery from kidney failure in patients with AKI requiring CRT when compared to CRT alone.

眾所周知，NEUTRALIZE-AKI 是我們進行的隨機對照關鍵試驗，旨在確定與單獨進行 CRT 相比，最多 10 次連續 24 小時的 SCD 療法治療是否可以改善需要 CRT 的 AKI 患者的 90 天生存率或腎衰竭恢復情況。

Our goal is to enroll a total of 200 patients with a primary endpoint identified as the composite of mortality or dialysis dependency at 90 days. Us reaching the 100th patient milestone triggers an interim analysis that will be conducted by the DSMB. This analysis will commence once our 100th patient has reached the 90-day primary endpoint. With some additional time for data and review, we anticipate the DSMB will submit their recommendation to the company in the third quarter of 2025.

我們的目標是招募總共 200 名患者，其主要終點是 90 天的死亡率或透析依賴性的綜合結果。當我們達到第 100 名患者里程碑時，DSMB 將進行中期分析。一旦我們的第 100 位患者達到 90 天主要終點，就會開始進行此分析。透過額外的數據和審查時間，我們預計 DSMB 將在 2025 年第三季向該公司提交建議。

To give you a sense of how the analysis will proceed, the pooled data will be analyzed based on the differences and outcomes between the treated patients versus controls. The DSMB will provide a recommendation to SeaStar Medical and the NEUTRALIZE-AKI investigators as to how to proceed with the trial. While we can't be certain of the recommendation from the Independent DSMB, we designed the in analysis to ensure we power the trial properly.

為了讓您了解分析如何進行，我們將根據接受治療的患者與對照組之間的差異和結果對總結數據進行分析。DSMB 將向 SeaStar Medical 和 NEUTRALIZE-AKI 研究人員提供有關如何進行試驗的建議。雖然我們不能確定獨立 DSMB 的建議，但我們設計了分析以確保我們正確地為試驗提供動力。

As Eric indicated, we must preserve the integrity of the trial. To set expectations properly, we will only convey the summary decision of the DSMB and no other clinical results will be shared.

正如埃里克所指出的，我們必須維護審判的完整性。為了正確設定預期，我們將僅傳達 DSMB 的總結決定，不會分享其他臨床結果。

The possible DSMB recommendations are as follows: continue the trial as planned to a total of 200, which is what we anticipate; increase the total sample size to ensure adequate power if the effect size appears to be smaller than anticipated; stop the trial for overwhelming efficacy; or lastly, stop the trial for futility. We expect a completely objective and unbiased recommendation by the DSMB based on what the interim data shows.

DSMB 可能的建議如下：按計劃繼續試驗，直至總數達到我們預期的 200；如果效果大小似乎小於預期，則增加總樣本量以確保足夠的功效；由於療效過強而停止試驗；或者最後，由於無效而停止試驗。我們期望 DSMB 根據中期數據顯示的情況提出完全客觀、公正的建議。

Now that we've reached the halfway point, we plan on redoubling our efforts towards getting to our goal of 200 as fast as humanly possible. As such, we plan to activate additional sites to ensure we are screening as many patients as needed.

現在我們已經完成了一半，我們計劃加倍努力，盡快實現 200 的目標。因此，我們計劃啟動更多站點，以確保我們能夠篩選盡可能多的患者。

I have to emphasize that per trial design, we're focusing the enrollment of the right type of patient through a process called enrichment. There are certain groups of patients, for example, that have absolutely no modifiable disease. In other words, they would live or die regardless of the intervention based on their underlying problem. Countless pivotal studies in the past have failed, falling victim to having too many of these types of patients.

我必須強調的是，根據試驗設計，我們正透過一個稱為「豐富」的過程來集中招募正確類型的患者。例如，有一部分患者完全沒有可治癒的疾病。換句話說，無論採取何種幹預措施，他們都會根據自身的潛在問題生存或死亡。過去無數的關鍵研究都因此類患者數量過多而失敗。

This will not be us. While the enrollment rate for this trial has been agonizingly slow at times, like this past month, I want to assure all of you that our team is 100% focused on completing enrollment by the end of this year. Additionally, I am certain that we are enrolling the right type of patients into our trial and appropriately excluding those who have no modifiable disease whatsoever. I know we have optimized our chances of a positive trial.

這不會是我們。雖然這次試驗的報名速度有時非常緩慢，例如上個月，但我向大家保證，我們的團隊將 100% 致力於在今年年底前完成報名。此外，我確信我們正在招募正確類型的患者參與我們的試驗，並適當地排除那些沒有任何可改變疾病的患者。我知道我們已經最大限度地提高了試驗成功的機會。

Now, looking beyond the in analysis, once we have completed the trial and achieved a 100% data log, we intend to rapidly analyze and report our data to the international medical community. Provided we meet our primary endpoint, we plan to complete our PMA filing and submit it to the FDA.

現在，除了分析之外，一旦我們完成試驗並實現 100% 的數據記錄，我們打算快速分析並向國際醫學界報告我們的數據。如果我們達到主要終點，我們計劃完成 PMA 申請並將其提交給 FDA。

The breakthrough device designation, which we hold for adult AKI, should help facilitate speedy communication between us and the FDA during the review and approval process, and as such, we would hope to have product available to patients sometime in the fourth quarter of 2026. The NEUTRALIZE-AKI trial is clearly our focus today.

我們為成人 AKI 授予的突破性設備頭銜應該有助於促進我們與 FDA 在審查和批准過程中的快速溝通，因此，我們希望在 2026 年第四季度的某個時候向患者提供該產品。NEUTRALIZE-AKI 試驗顯然是我們今天的重點。

However, our strategic goal as a company is to widen the addressable market rapidly to target other critical unmet medical needs for the treatment of destructive hyperinflammation through additional clinical trials. Beyond the adult AKI indication, we have been awarded breakthrough device designation for five others, including the treatment of patients with cardio renal syndrome, patients with hepatorenal syndrome, patients with end-stage renal disease, and both adult and pediatric patients undergoing cardiac surgery.

然而，作為一家公司，我們的策略目標是透過額外的臨床試驗，迅速擴大目標市場，以滿足治療破壞性高發炎的其他關鍵未滿足的醫療需求。除了成人 AKI 適應症外，我們還獲得了其他五項突破性設備稱號，包括治療心腎綜合徵患者、肝腎綜合徵患者、終末期腎病患者以及接受心臟手術的成人和兒科患者。

Given the organ and disease agnostic characteristic of our therapy, there are several more indications to come. We believe that AKI is just the beginning of our opportunity to spare organs and save lives in these patient populations.

鑑於我們的療法具有與器官和疾病無關的特性，未來還會有更多適應症。我們相信，AKI 只是我們為這些患者群體保留器官、挽救生命的機會的開始。

With that as a summary of our clinical developmental efforts and goals, I turn the call over to our CFO, David Greene.

以上就是我們臨床開發工作和目標的總結，我將電話轉給我們的財務長大衛‧格林 (David Greene)。

Thank you, Kevin, and thank you all for joining us today. I'll describe our first-quarter financial results and conclude with some of our expectations for the remainder of 2025. First, for some housekeeping, please note that our Form 10-Q will be filed with the SEC within the next 24 hours. You can find it at seastarmedical.com or SEC.gov.

謝謝你，凱文，也謝謝大家今天加入我們。我將描述我們的第一季財務業績，並總結我們對 2025 年剩餘時間的一些預期。首先，為了方便處理，請注意，我們的 10-Q 表格將在接下來的 24 小時內提交給美國證券交易委員會 (SEC)。您可以在 seastarmedical.com 或 SEC.gov 上找到它。

Before I turn to our financial results for the quarter, let me also say that our progress to date in 2025 has included a number of key milestones for the company. As I indicated on our year-end call, our accomplishments in 2024 and now into 2025 have positioned SeaStar to build on the first two quarters of commercial revenue for QUELIMMUNE and push forward the NEUTRALIZE-AKI pivotal trial.

在介紹本季的財務表現之前，我還要說一下，我們在 2025 年迄今的進展包括公司的許多關鍵里程碑。正如我在年終電話會議上所指出的，我們在 2024 年以及現在 2025 年取得的成就使 SeaStar 能夠在 QUELIMMUNE 前兩個季度的商業收入基礎上再接再厲，並推進 NEUTRALIZE-AKI 關鍵試驗。

Since then, we've made good progress in our priorities as reported in our press release today. To highlight three Q1 accomplishments, we achieved greater adoption of QUELIMMUNE from existing customers, which drove increased revenue in the first quarter. We pushed forward our NEUTRALIZE-AKI pivotal trial for adult AKI patients reaching the 50% enrollment milestone, and we managed resources during the quarter that resulted in lower sequential operating expenses.

自那時以來，我們在優先事項上取得了良好進展，正如我們今天的新聞稿中所報導的那樣。突顯第一季的三項成就，我們獲得了現有客戶對 QUELIMMUNE 的更多採用，這推動了第一季營收的成長。我們推進了 NEUTRALIZE-AKI 針對成年 AKI 患者的關鍵試驗，達到了 50% 的入組率里程碑，並且我們在本季度管理了資源，從而降低了連續的營運費用。

We also strengthened our balance sheet with the addition of new capital and maintained our practice of careful attention to spending. And with that, I'll turn to our first-quarter 2025 financial results. We recorded our highest quarterly revenue to date by achieving a four-fold increase in net revenue through sales of QUELIMMUNE therapy.

我們也透過注入新資本來增強資產負債表，並繼續謹慎關注支出​​的做法。接下來，我將介紹我們 2025 年第一季的財務表現。我們透過銷售 QUELIMMUNE 療法實現了淨收入成長四倍，創下了迄今為止最高的季度收入。

Revenue for the first quarter of 2025 was $293,000 compared to approximately $68,000 in the fourth quarter of 2024 and $0 in the year ago first quarter. As we indicated last quarter, we anticipate the sales will be lumpy in the initial phase of the launch, but we expect to see an overall trend of increases in revenue as existing customers expand their usage of QUELIMMUNE, and we add to the total number of hospitals purchasing QUELIMMUNE therapy.

2025 年第一季的營收為 293,000 美元，而 2024 年第四季的營收約為 68,000 美元，去年同期第一季的營收為 0 美元。正如我們上個季度所指出的，我們預計在推出的初始階段銷售額將會不穩定，但隨著現有客戶擴大對 QUELIMMUNE 的使用，以及購買 QUELIMMUNE 療法的醫院總數的增加，我們預計收入總體將呈增長趨勢。

To provide some texture to the Q1 revenue report, we are pleased that all existing customers purchase QUELIMMUNE during the quarter. And as Tim indicated, we are quite optimistic about new hospitals coming on as customers in 2025, which will give more children access to our life-saving therapy.

為了給第一季營收報告提供一些細節，我們很高興所有現有客戶在本季購買了 QUELIMMUNE。正如提姆所說，我們對 2025 年新醫院成為客戶感到非常樂觀，這將使更多兒童能夠接受我們的救命療法。

Moving to cost of goods sold, the Q1 financial statements reflect no cost of goods sold. This is consistent with GAAP and due to sales of QUELIMMUNE units that have been previously recognized as research and development expense. As we build and then sell new inventory as a commercial enterprise, we will record cost of goods sold matching sales from inventory.

轉向銷售成本，第一季財務報表未反映銷售成本。這與 GAAP 一致，並且是由於 QUELIMMUNE 單位的銷售先前已被確認為研發費用。當我們作為商業企業建立並銷售新庫存時，我們將記錄與庫存銷售額相符的銷售成本。

On a related note, you may have noticed that we recognized an inventory balance for the first time on our 331 balance sheet. We anticipate Q2 to be a transition corridor as we begin to recognize COGS.

相關地，您可能已經注意到，我們在 331 資產負債表上首次確認了庫存餘額。隨著我們開始認識到 COGS，我們預計第二季將成為一個過渡時期。

Operating expenses increased modestly to $4.1 million in the first quarter of 2025 compared to $3.9 million in Q1 of 2024. The change was primarily due to increased spending for our commercial launch and growing enrollment in the NEUTRALIZE-AKI trial. This was partially offset by reduced G&A expenses resulting from a decline in accounting-related costs and reductions in legal and consulting expenses.

2025 年第一季的營運費用小幅增加至 410 萬美元，而 2024 年第一季為 390 萬美元。這項變更主要是由於我們商業發布的支出增加以及 NEUTRALIZE-AKI 試驗的參與人數增加。這被會計相關成本下降以及法律和諮詢費用減少導致的一般及行政費用減少部分抵消。

And finally, our net loss for the quarter of first quarter of 2025 declined to $3.7 million compared to a loss of $12.7 million in Q1 of 2024. We ended the quarter with approximately $5.3 million in cash.

最後，我們 2025 年第一季的淨虧損從 2024 年第一季的 1,270 萬美元下降至 370 萬美元。本季末我們擁有約 530 萬美元的現金。

Looking forward, we'll focus our resources and our top three objectives: number one, new customer acquisitions for QUELIMMUNE; number two, completing the NEUTRALIZE-AKI pivotal trial; and number three, preparing to file a PMA following the completion of the adult AKI pivotal trial.

展望未來，我們將集中資源和三大目標：第一，為 QUELIMMUNE 獲取新客戶；第二，完成 NEUTRALIZE-AKI 關鍵試驗；第三，在完成成人 AKI 關鍵試驗後準備提交 PMA。

In wrapping up as we drive our strategic objectives forward, we expect forward momentum to continue as we bring our life-saving SCD therapy to more patients and clinicians and as more investors become aware of the significant market opportunity developing for our SCD therapy.

在我們推動策略目標的過程中，我們預計前進的勢頭將繼續下去，因為我們將拯救生命的 SCD 療法帶給更多的患者和臨床醫生，並且隨著更多的投資者意識到我們的 SCD 療法正在發展的巨大市場機會。

And with that, I'll hand the call back to Eric.

說完這些，我就把電話交還給 Eric。

Yeah, thanks, Dave. Our goal today for our first-quarter financial results conference call was to provide you with a summary of our progress as well as a clear picture of why we believe the future opportunities of SeaStar Medical are significant.

是的，謝謝，戴夫。我們今天召開第一季財務業績電話會議的目的是向您提供我們進展的摘要，並清楚地說明我們為何相信 SeaStar Medical 的未來機會如此重要。

We plan to continue these calls on a quarterly basis. We are also reaching out to a broader investment investor base through various media outlets and plan to host fireside chats when we have educational information to share about SeaStar Medical. We are passionate about our ability to provide a life-saving therapy to critically ill patients who today have no alternative treatment for calming the cytokine storm caused by an overactive immune system.

我們計劃每季繼續進行這些電話會議。我們也透過各種媒體管道接觸更廣泛的投資者群體，並計劃在有關於 SeaStar Medical 的教育資訊可以分享時舉辦爐邊談話。我們熱衷於為重症病人提供挽救生命的治療，這些病人目前沒有其他治療方法來平息因免疫系統過度活躍而引起的細胞激素風暴。

As we complete the NEUTRALIZE-AKI pivotal trial enrollment, we look forward to reporting the results. Provided the data are supportive, we plan to file a PMA in 2026. If approved, we believe a significant opportunity to capture a sizable portion of the adult AKI market exists.

隨著我們完成 NEUTRALIZE-AKI 關鍵試驗招募，我們期待報告結果。如果數據支持，我們計劃在 2026 年提交 PMA。如果獲得批准，我們相信這將有很大機會佔領成人 AKI 市場的相當一部分。

In short, we believe we are continuing to create strong value for our investors and stakeholders, and we'll be looking to close out what we see as a substantial GAAP in our current market cap and the outlook that we have for our company.

簡而言之，我們相信我們將繼續為我們的投資者和利害關係人創造巨大的價值，並且我們將尋求在目前的市值和我們對公司的前景中實現我們認為的可觀的 GAAP。

With that, I'll ask the operator to open the call for questions. Operator?

說完這些，我將請接線生開始回答問題。操作員？

(Operator Instructions)

（操作員指示）

Nick Sherwood, Maxim Group.

尼克‧舍伍德 (Nick Sherwood)，馬克西姆集團 (Maxim Group)。

Hey, good evening. Can you tell me how many sites are currently activated for the adult clinical trial?

嘿，晚上好。您能告訴我目前有多少個站點已啟動成人臨床試驗嗎？

Yeah, hey, thank you, Nick. Kevin, why don't you take that one?

是的，嘿，謝謝你，尼克。凱文，你為什麼不拿那個？

Yes, we currently have 15 activated and probably another five that we plan to activate over the next three months.

是的，我們目前已啟動 15 個，並且計劃在未來三個月內再啟動另外 5 個。

Okay. And then what's the total number of pediatric hospitals that you have as customers currently?

好的。那麼，目前你們的客戶兒科醫院總數是多少呢？

Yeah, Tim, you want to take that?

是的，提姆，你想接受這個嗎？

Sure, we have six sites that are commercially active and multiple others that are moving through the IRB process.

當然，我們有六個商業活躍的站點，還有多個站點正在進行 IRB 流程。

Okay, and yeah, kind of talking about that IRB process and the pipeline. What sort of pipeline growth have you seen in the first quarter compared to the fourth quarter? Do you think that -- I mean, revenues were up at the time, sequentially in this quarter. Is there a lot of word of mouth that where you're seeing that that pipeline really starting to accelerate in this first quarter?

好的，是的，談論的是 IRB 流程和管道。與第四季相比，第一季的管道成長情況如何？您是否認為—我的意思是，本季的營收當時較上季成長。您是否有很多口耳相傳看到該管道在第一季確實開始加速？

Yeah, thanks for the question, by the way. It's a combination of things. It is experience that existing sites have. We have a way that these sites are able to communicate with each other and share their experiences and they're noticing a difference when they use QUELIMMUNE therapy.

是的，順便說一句，謝謝你的提問。這是多種因素的綜合。這是現有站點所擁有的經驗。我們有一種方法可以讓這些站點相互交流並分享他們的經驗，並且他們在使用 QUELIMMUNE 療法時注意到了差異。

So that's -- one aspect of it is definitely word of mouth, but we actively engage these hospitals as well and we approach them and talk with them, and quite often, they're very interested in adopting ultimately QUELIMMUNE therapy. And then it just becomes an operational exercise and based on the type of hospital is and the resources they have, that kind of tells you what the timeline is going to be.

所以，這其中一方面肯定是口耳相傳，但我們也積極與這些醫院接觸，與他們接觸、交談，而且很多時候，他們對最終採用 QUELIMMUNE 療法非常感興趣。然後它變成了一項操作演習，根據醫院的類型和他們擁有的資源，它會告訴你時間表是什麼樣的。

So sometimes it's easy and it's fairly quick and other times it takes a little bit longer, but there's no shortage of interest in these institutions about QUELIMMUNE therapy and what the potential of this therapy represents to these patients suffering with pediatric AKI.

所以有時它很容易而且相當快，有時則需要更長的時間，但這些機構對 QUELIMMUNE 療法以及這種療法對患有兒童 AKI 的患者的潛力並不缺乏興趣。

Yeah, that all makes a ton of sense and I appreciate the detail. And then kind of shifting gears, talking about the new breakthrough designations, can you talk about kind of how important these two additional breakthrough designations are and how you're prioritizing the various regulatory processes?

是的，這一切都非常有意義，我很欣賞這些細節。然後換個話題，談論新的突破性稱號，您能否談談這兩個額外的突破性稱號有多重要，以及您如何優先考慮各種監管流程？

Because you have to be so many designations you kind of have to -- you don't want to spread your resources too thin, I imagine.

因為你必須承擔這麼多的職責，所以你必須──我想你不想把你的資源分散得太薄。

Yeah, so Nick, Kevin, why don't you address kind of the clinical unmet need that's there in the cardiac surgeries, and then I'll take the second part of that question.

是的，尼克、凱文，你們為什麼不討論一下心臟手術中存在的臨床未滿足的需求，然後我來回答這個問題的第二部分。

Yeah, thank you, Nick, for that question. So cardiac surgery is one of the largest costs for hospitals in the country, and there was a Newsweek article that came out today that really emphasized that. And part of the reason for that is a relatively high proportion of those patients have a complication that results in AKI. And as a result, both in adults and pediatrics, we believe that this is a massive target of opportunity where we can make a big difference in these outcomes.

是的，謝謝你，尼克，提出這個問題。因此，心臟手術是全國醫院最大的開銷之一，今天《新聞週刊》的一篇文章也特別強調了這一點。部分原因是這些患者中相當高比例的人出現了導致 AKI 的併發症。因此，我們相信，無論對於成人還是兒科來說，這都是一個巨大的機會目標，我們可以對這些結果產生重大影響。

So what's the point of undergoing a cardiac surgery that's very intense and associated with many hospital days if you're not able to survive and you have a complication that commits you to hemodialysis, we intend on preventing that. So in order to look at this, we're going to need to do additional clinical trials.

因此，如果您無法存活，並且出現併發症而需要進行血液透析，那麼接受非常緊張且需要住院很多天的心臟手術有什麼意義呢？我們打算預防這種情況。因此，為了研究這個問題，我們需要做額外的臨床試驗。

We're hoping that with the adult launch, some of these trials will be funded via a grant funding and non-diluted funding, and a lot of these centers are very interested in applying the SCD in their patient population and so we also anticipate investigator initiated studies as well.

我們希望，隨著成人試驗的推出，其中一些試驗將透過撥款和非稀釋資金獲得資助，並且許多中心都非常有興趣在其患者群體中應用 SCD，因此我們也期待研究者發起的研究。

So a combination of things that will help drive our pursuit to get this device approved for that specific patient population. Now I have to say that with an approval for AKI alone, there will be adoption in those types of patients, so we will be seeing data trickle in already, even with just the AI indication alone.

因此，多種因素的結合將有助於我們爭取讓該設備獲得針對特定患者群體的批准。現在我必須說，只要獲得針對 AKI 的批准，這類患者就會採用該療法，因此，即使只有 AI 適應症，我們也會看到數據逐漸湧入。

Yeah, and just to add on to that, what Kevin has said is that, the commercial and medical affairs teams are working diligently to assess kind of the market need penetration dynamics of the five additional indications where we have these breakthrough device designations.

是的，補充一點，凱文說過，商業和醫療事務團隊正在努力評估我們擁有這些突破性設備頭銜的另外五個適應症的市場需求滲透動態。

Given that the SCD therapy is agnostic to these disease states, and this is that our first adult product will be in the critical care market, it's logical that we could easily add indications in the space and sell products to the same customers in those same ICU units. So you know, we're really excited about the opportunity to rapidly expand our product offering that that as we said in kind of the prepared remarks.

鑑於 SCD 療法對這些疾病狀態無關，而且我們的第一款成人產品將進入重症監護市場，因此我們可以輕鬆地在該領域添加適應症，並將產品銷售給相同 ICU 病房中的相同客戶，這是合乎邏輯的。所以你知道，我們對能夠迅速擴大我們的產品供應的機會感到非常興奮，正如我們在準備好的評論中所說的那樣。

Okay, I appreciate all the details. So it sounds like once you get this first adult approval that the subsequent ones are going to be able to move a lot more quickly just because they're getting a lot of real world data and you've been through the process before.

好的，我很感謝你提供的所有細節。因此聽起來，一旦你獲得了第一個成年人的批准，後續的批准將能夠進展得更快，因為他們獲得了大量現實世界的數據，而且你之前已經經歷過這個過程。

Absolutely. I think each one of these, yeah.

絕對地。我認為每一個都是這樣的。

Yeah, go ahead.

是的，繼續吧。

Yeah, absolutely. I mean, one of the things that we're looking at with the AKI trial is safety. And so when the safety issue has been addressed. And we're getting data for the specific other populations, we believe that it'll get easier and easier and the floodgates are open.

是的，絕對是如此。我的意思是，我們在 AKI 試驗中關注的事情之一就是安全性。當安全問題解決時。我們正在獲取其他特定人群的數據，我們相信這會變得越來越容易，閘門已經打開。

Okay. Awesome. Well, thank you for answering all my questions, and I will return to the queue.

好的。驚人的。好吧，感謝您回答我的所有問題，我會回到隊列。

Thanks, Nick.

謝謝，尼克。

(Operator Instructions)

（操作員指示）

There are no further questions. At this time, I will turn the call back over to Jackie Cosman.

沒有其他問題了。現在，我將把電話轉回給 Jackie Cosman。

Thank you, Tiffany, and thank you all for joining us today for the SeaStar Medical year first-quarter financial results conference call. If you have questions, please contact us at ir@seastarmed.com or visit our website to see our latest news, product, pipeline, and company information. Thank you and goodbye.

謝謝你，蒂芬妮，也謝謝大家今天參加 SeaStar Medical 今年第一季財務業績電話會議。如果您有任何疑問，請透過 ir@seastarmed.com 聯絡我們或造訪我們的網站查看我們的最新新聞、產品、管道和公司資訊。謝謝，再見。

Ladies and gentlemen, this concludes today's call. Thank you all for joining. You may now disconnect.

女士們、先生們，今天的電話會議到此結束。感謝大家的加入。您現在可以斷開連線。