SeaStar Medical Holding Corp (ICU) 2025 Q4 法說會逐字稿

Good day and thank you for standing by. Welcome to the SeaStar Medical's Q4 2025 financial results conference call. (Operator Instructions)

您好，感謝您的耐心等待。歡迎參加 SeaStar Medical 2025 年第四季財務業績電話會議。（操作說明）

I would not like to hand the conference over to your speaker today, Jackie Cossmon.

我今天不想把會議交給你們的演講嘉賓傑基·科斯蒙。

Thank you, Josh. Good afternoon and thank you for joining the SeaStar Medical fourth-quarter and year-end 2025 financial results conference call. I'm Jackie Cossmon with Wheelhouse Life Science Advisors. Joining me from SeaStar Medical today are Eric Shlorff, Chief Executive Officer; Dr. Kevin Chung, Chief Medical Officer; Tim Veracek, Senior Vice President of Commercial and Business Operations; and Mike Messinger, Chief Financial Officer.

謝謝你，喬希。下午好，感謝各位參加 SeaStar Medical 2025 年第四季及全年財務業績電話會議。我是來自 Wheelhouse Life Science Advisors 的 Jackie Cossmon。今天與我一同出席的還有來自 SeaStar Medical 的執行長 Eric Shlorff；首席醫療官 Kevin Chung 博士；商業和業務營運資深副總裁 Tim Veracek；以及財務長 Mike Messinger。

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.

我想提醒各位聽眾，管理階層在本次電話會議中發表的評論將包含聯邦證券法意義上的前瞻性陳述。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任何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 conference call contains information that is accurate only as of the date of the live broadcast, March 25, 2026. 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說明，請查閱 SeaStar Medical 向美國證券交易委員會提交的文件。此外，本次電話會議的內容所包含的資訊僅在直播當天（2026 年 3 月 25 日）是準確的。除法律另有規定外，SeaStar Medical 不承擔任何義務修改或更新任何聲明以反映事件或情況。

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

現在，我想把電話交給艾瑞克。艾瑞克？

Yeah. Thank you, Jackie, and thank you all for joining us today. We are excited to share with you our achievements over the past year and our future plans and passion for what we are doing here at SeaStar Medical.

是的。謝謝傑基，也謝謝各位今天蒞臨現場。我們很高興與您分享過去一年我們所取得的成就、未來的計劃以及我們對SeaStar Medical所做工作的熱情。

In 2025 and into the first quarter of this year, we expanded the use of QUELIMMUNE therapy for ultra-rare pediatric AKI. We added 13 new customers from top-rated children's hospitals, bringing the total customer base to 16 and building increased depth in customer orders.

2025 年及今年第一季度，我們擴大了 QUELIMMUNE 療法在罕見兒科 AKI 的應用。我們從頂級兒童醫院新增了 13 位客戶，使客戶總數達到 16 位，並提高了客戶訂單的深度。

We reported net revenue of over $1 million from QUELIMMUNE sales in 2025, with pharmaceutical-like gross profit margins above 90%. In addition, we advance the development of the SCD therapy as a potential treatment of adult patients with AKI in the ICU receiving continuous renal replacement therapy, achieving over 50% enrollment in the trial, with 181 of the 339 patients enrolled to date in the neutralized AKI pivotal trial.

我們報告稱，2025 年 QUELIMMUNE 的銷售淨收入超過 100 萬美元，毛利率與藥品類似，超過 90%。此外，我們推進了 SCD 療法的發展，將其作為 ICU 中接受連續腎臟替代療法的 AKI 成年患者的潛在治療方法，試驗入組率已超過 50%，迄今為止，在中和 AKI 的關鍵性試驗中，339 名患者中有 181 名入組。

We also initiate a modular pre-market application, or PMA, submission process for the SCD therapy at a potential treatment for the adult AKI indication. We have already been granted breakthrough device designation by the FDA for this indication, but we are hoping to potentially speed the PMA approval process through this modular PMA submission.

我們還啟動了針對 SCD 療法的模組化上市前申請 (PMA) 提交流程，該療法預計將用於治療成人 AKI。我們已經獲得了 FDA 授予的該適應症的突破性醫療器材認定，但我們希望透過這種模組化的 PMA 提交方式，加快 PMA 的審批流程。

And importantly, we maintain good cost controls and improve the company's balance sheet substantially through the addition of approximately $24 million of capital during 2025, as well as a reduction of over $3 million in operating liabilities.

更重要的是，我們保持了良好的成本控制，並透過在 2025 年增加約 2,400 萬美元的資本以及減少超過 300 萬美元的營運負債，大幅改善了公司的資產負債表。

Now, turning to 2026. We have laid out four key milestones to drive stakeholder value and position us solidly for 2027 and beyond. Our primary goal this year and a major driver of our future potential revenue is to advance the SCD therapy for the adult AKI indication.

現在，讓我們展望2026年。我們制定了四個關鍵里程碑，旨在提升利害關係人的價值，並為 2027 年及以後的發展奠定堅實的基礎。我們今年的主要目標，也是我們未來潛在收入的主要驅動力，是推動 SCD 療法在成人 AKI 適應症的應用。

We plan to complete enrollment in the neutralized AKI pivotal trial around the end of 2026. A successful trial would position us to finalize our PMA submission next year. With a market opportunity that is 50 times that of the pediatric AKI market, we are very excited about this future opportunity.

我們計劃在 2026 年底左右完成中和 AKI 關鍵性試驗的招募工作。如果試驗成功，我們將能夠在明年完成PMA申請。鑑於該市場機會是兒科 AKI 市場的 50 倍，我們對這一未來機會感到非常興奮。

With respect to QUELIMMUNE, we look to further expand our customer base in 2026. We have strong momentum in the pediatric market with the publication of our SAVE Registry data in pediatric nephrology and strong testimonials from existing customers. We plan to add 15 new top-ranked children's medical centers this year, with a goal of achieving $2 million in net product revenue from QUELIMMUNE sales in 2026, a significant increase over 2025.

對於 QUELIMMUNE，我們期待在 2026 年進一步擴大客戶群。我們在兒科市場擁有強勁的發展勢頭，這得益於我們在兒科腎臟病學領域發布的 SAVE 註冊數據以及現有客戶的有力推薦。我們計劃今年新增 15 家頂級兒童醫療中心，目標是在 2026 年實現 QUELIMMUNE 銷售的淨產品收入 200 萬美元，比 2025 年大幅成長。

We will also evaluate the broader applicability of the SCD therapy in a new indication where we have been awarded the Breakthrough Device Designation Approval Pathway through the FDA. We announced in late 2025 the initiation of a clinical trial of the SCD therapy in patients with acute congestive heart failure with cardiorenal syndrome awaiting left ventricular assist device implantation.

我們還將評估 SCD 療法在新適應症中的更廣泛適用性，我們已透過 FDA 獲得了突破性醫療器材認定批准途徑。我們在 2025 年底宣布啟動 SCD 療法的臨床試驗，該療法用於治療患有急性充血性心臟衰竭和心腎綜合徵、等待植入左心室輔助裝置的患者。

This trial is investigator-led and being funded by the NIH. It is in the area of critical need, and we are hoping that we can provide a solution to these patients with little hope of survival because they are too compromised due to hyperinflammation to undergo the surgery required to improve their condition.

這項試驗由研究者主導，並由美國國立衛生研究院資助。這是急需的領域，我們希望能夠為這些患者提供解決方案，因為他們由於過度發炎而身體狀況極其糟糕，無法接受改善病情所需的手術，因此幾乎沒有生存的希望。

Finally, we will work with the FDA for expedited approval of our pipeline indications. Humanitarian use and breakthrough device designations would enable us to potentially provide earlier access to patients with destructive hyperinflammatory conditions that face permanent organ failure or loss of life. In short, we have an exciting year ahead and look forward to reporting our progress to you.

最後，我們將與FDA合作，加速我們研發管線適應症的批准。人道主義用途和突破性醫療器材認定將使我們能夠更早地為患有破壞性過度發炎、面臨永久性器官衰竭或死亡的患者提供治療。總而言之，我們即將迎來激動人心的一年，期待向您報告我們的進展。

I now -- I will turn it over to Tim to discuss our commercial achievements and market opportunities. Tim?

現在，我將把發言權交給提姆，讓他來討論我們的商業成就和市場機會。提姆？

Thanks, Eric, and thanks, everyone, for joining us today. I'm pleased to report that we ended the year with strong momentum, and that momentum continues into the first quarter of this year. We added six additional customers since the beginning of the fourth quarter, and importantly, we're seeing a substantial uptick in orders from many of our customers.

謝謝艾瑞克，也謝謝各位今天蒞臨。我很高興地報告，我們以強勁的勢頭結束了這一年，而且這種勢頭延續到了今年的第一季。自第四季初以來，我們新增了六位客戶，更重要的是，我們看到許多客戶的訂單量大幅增加。

Our QUELIMMUNE net revenue in the fourth quarter was $315,000, and the first-quarter net revenue has already exceeded that number. Now, to put that in perspective, We have indicated all along that this is an ultra-rare market. It's a market that is important to us, not only because we believe we are saving lives, but because it also provides great validation of our SCD technology, and importantly, it paves the way for future potential opportunities in the adult market.

我們第四季的 QUELIMMUNE 淨收入為 315,000 美元，而第一季的淨收入已經超過了這個數字。現在，為了更好地理解這一點，我們一直都指出，這是一個極為罕見的市場。這個市場對我們來說很重要，不僅因為我們相信我們正在拯救生命，還因為它也極大地驗證了我們的 SCD 技術，更重要的是，它為我們未來在成人市場的潛在機會鋪平了道路。

With the growing adoption of the QUELIMMUNE therapy, key opinion leaders in the field are now publishing and reporting on the use of QUELIMMUNE. We reported in February that nine pediatric AKI experts co-authored the publication of the SAVE Registry data in the peer-reviewed journal Pediatric Nephrology. In addition, later this month, we will sponsor and host an educational symposium at the AKI CRRT meeting in San Diego.

隨著 QUELIMMUNE 療法的日益普及，該領域的關鍵意見領袖現在正在發表和報告有關 QUELIMMUNE 的使用情況。我們在 2 月報道過，九位兒科 AKI 專家共同撰寫了 SAVE 註冊數據在同行評審期刊《兒科腎臟病學》上發表的文章。此外，本月晚些時候，我們將在聖地牙哥舉行的 AKI CRRT 會議上贊助並舉辦教育研討會。

I've previously discussed plans to build the QUELIMMUNE brand in pediatric AKI, and this symposium is an example of a new resource we are developing, an Advanced Practice Provider Advisory Board. This group of patient care level and operational experts will participate in a panel discussion aimed directly at the QUELIMMUNE adoption process to provide aspiring institutions with best practices and enable them to shorten the overall timeline to QUELIMMUNE activation.

我之前討論過在兒科 AKI 領域打造 QUELIMMUNE 品牌的計劃，而本次研討會就是我們正在開發的新資源——高級實踐提供者諮詢委員會的一個例子。這組由患者護理水平和運營專家組成的小組將參加一個專門針對 QUELIMMUNE 採用過程的小組討論，旨在為有志於採用 QUELIMMUNE 的機構提供最佳實踐，並使他們能夠縮短 QUELIMMUNE 激活的總體時間。

This event already has a large list of attendees and will feature discussions on the use of QUELIMMUNE by a number of prominent key opinion leaders who have been early adopters of the QUELIMMUNE therapy. Also, an abstract by Dr. James Odom at the University of Alabama Birmingham Children's Hospital has been accepted for presentation. It will report findings on the anti-inflammatory properties of our SCD therapy.

本次活動已公佈了大量與會者名單，並將邀請多位早期採用 QUELIMMUNE 療法的知名意見領袖，就 QUELIMMUNE 的使用情況進行討論。此外，阿拉巴馬大學伯明翰兒童醫院的詹姆斯·奧多姆博士的摘要已被接受進行展示。它將報告我們 SCD 療法的抗炎特性方面的研究結果。

In short, we're seeing strong growth in QUELIMMUNE orders, with the pediatric AKI field now viewing it as a key therapy for renal replacement therapy patients in the ICU, and one highly regarded institution has formally adopted QUELIMMUNE as its standard of care.

簡而言之，我們看到 QUELIMMUNE 的訂單量大幅增長，兒科 AKI 領域現在將其視為 ICU 中腎臟替代治療患者的關鍵療法，而且一家備受推崇的機構已正式採用 QUELIMMUNE 作為其標準治療方案。

Now, turning to 2026, we have great expectations to help patients by delivering QUELIMMUNE therapy to more pediatric hospital systems. We are relentlessly focused on adding new sites as quickly as possible, and the more sites we add, the more we de-risk our revenue variability and ultimately generate a predictable and reliable stream for our investors and SeaStar Medical. That's always our goal.

現在，展望 2026 年，我們滿懷希望地將 QUELIMMUNE 療法推廣到更多兒科醫院系統，以幫助患者。我們正全力以赴地盡快增加新站點，我們增加的站點越多，我們的收入波動風險就越小，最終可以為我們的投資者和 SeaStar Medical 創造可預測和可靠的收入流。這始終是我們的目標。

The pediatric AKI market is small but important, and we believe it represents a total market of about $100 million. And we've refined our target market population to pediatric patients in the top 50 children's hospitals in the US. We believe we can capture a relevant share of this market and create significant value for our stockholders while delivering important revenue for SeaStar Medical. And we believe this is only the beginning of the commercial opportunities for our SCD therapy.

兒科急性腎損傷市場雖然規模小，但卻十分重要，我們認為其市場總額約為 1 億美元。我們將目標市場人口縮小到美國排名前 50 名的兒童醫院的兒科患者。我們相信，我們能夠佔據該市場的重要份額，為股東創造重大價值，同時為 SeaStar Medical 帶來重要的收入。我們相信這只是我們 SCD 療法商業機會的開始。

And with that, I'll turn the presentation over to our Chief Medical Officer, Kevin Chung, who will discuss our neutralized AKI progress to date. Kevin?

接下來，我將把演講交給我們的首席醫療官 Kevin Chung，他將討論我們迄今為止在控制 AKI 方面取得的進展。凱文？

Thanks, Tim, and thank you to everyone joining us today. We are working diligently to complete enrollment in our neutralized AKI pivotal trial. Since the start of the fourth quarter, we've onboarded four additional clinical sites and enrolled 55 more patients, bringing total enrollment to 181 of our target of 339 patients.

謝謝提姆，也謝謝今天所有到場的朋友。我們正在努力完成中和 AKI 關鍵性試驗的受試者招募工作。自第四季開始以來，我們新增了四個臨床中心，並招募了 55 名患者，使總招募人數達到 181 人，而我們的目標是 339 名患者。

For those less familiar, neutralized AKIs are randomized controlled trial designed to assess whether up to 10 sequential 24-hour STD treatments can improve 90-day survival or renal recovery in critically ill patients with acute kidney injury requiring continuous renal replacement therapy, or CRRT.

對於較不熟悉的人來說，中和性 AKI 是一項隨機對照試驗，旨在評估最多 10 次連續 24 小時 STD 治療是否可以改善需要連續性腎臟替代療法 (CRRT) 的急性腎損傷重症患者的 90 天存活率或腎臟恢復。

The primary endpoint is a composite of mortality or dialysis dependence at 90 days. We are targeting completion of enrollment around year end, which positions us to potentially report top-line results in mid-2027. We are aggressively expanding our clinical footprint, including the addition of high-volume sites over the next quarter to drive enrollment momentum.

主要終點是 90 天內死亡或需要透析的複合終點。我們的目標是在年底前後完成招生工作，這將使我們能夠在 2027 年年中公佈初步業績。我們正在積極擴大臨床規模，包括在接下來的一個季度增加高容量的試驗中心，以推動患者招募勢頭。

In parallel, we are proactively preparing components of the pre-market approval that are not dependent on clinical outcomes in alignment with FDA guidance to help streamline the review process. Upon completion and review of the neutralized AKI clinical trial and contingent on positive efficacy and safety outcomes, we intend to move quickly to submit the remaining PMA components under our breakthrough device designation, positioning us for potentially accelerated FDA review.

同時，我們正在積極準備上市前審批中不依賴臨床結果的部分，以符合 FDA 的指導方針，從而幫助簡化審查流程。在完成和審查中和 AKI 臨床試驗並取得積極的療效和安全性結果後，我們打算迅速提交剩餘的 PMA 組件，以獲得突破性醫療器材認定，從而使我們有機會獲得 FDA 的加速審查。

Our pediatric AKI indication was approved under a humanitarian device exemption pathway, a pathway that requires site-level IRB approvals prior to use, and in our case, included the mandatory save registry to track post-market safety of QUELIMMUNE. By contrast, an approval of STD therapy for adult AKI would enable commercialization as a therapeutic device without these IRB-related barriers, significantly simplifying hospital adoption and supporting more rapid commercial expansion.

我們的兒科 AKI 適應症是根據人道主義器械豁免途徑獲得批准的，該途徑要求在使用前獲得機構審查委員會的批准，並且在我們的案例中，還包括強制性的拯救登記，以追蹤 QUELIMMUNE 上市後的安全性。相較之下，如果成人 AKI 的 STD 療法獲得批准，則可以將其作為治療設備進行商業化，而無需這些與 IRB 相關的障礙，從而大大簡化醫院的採用，並支持更快速的商業擴張。

Let me now turn to our SAVE Registry, which tracks the commercial use of our QUELIMMUNE therapy in critically ill children. We reported earlier this month that we have completed the enrollment of 50 patients in the SAVE Registry. This was the FDA's new enrollment requirement, down from their original request of 300 patients, following its review of the data from the first 21 patients in the Registry. We are awaiting the 28-day safety data from our last patients enrolled in the registry and will soon submit a report of the top-line safety data to the FDA.

現在讓我來介紹一下我們的 SAVE 登記處，該登記處追蹤了我們的 QUELIMMUNE 療法在重症兒童中的商業用途。本月初我們曾報道，我們已完成 SAVE 註冊登記中 50 名患者的登記工作。這是 FDA 在審查了註冊中心前 21 名患者的數據後，提出的新的註冊要求，比最初要求的 300 名患者有所減少。我們正在等待註冊登記中最後一批患者的 28 天安全性數據，並將很快向 FDA 提交初步安全性數據報告。

I'd like to briefly highlight a recent publication in Pediatric Nephrology, which reports early post-approval experience with QUELIMMUNE from the first 21 patients enrolled in the SAVE Registry. This work was co-authored by leading experts, and we were pleased to see it published in a highly respected peer-reviewed journal.

我想簡要介紹一下最近發表在《兒科腎臟病學》雜誌上的一篇文章，該文章報告了 SAVE 註冊研究中前 21 名患者使用 QUELIMMUNE 的早期上市後經驗。這項研究由多位頂尖專家共同撰寫，我們很高興看到它發表在備受尊敬的同行評審期刊上。

In this initial cohort of pediatric patients with AKI and sepsis requiring renal replacement therapy, there were no device-related adverse events, no infections, and no evidence of immune suppression. Survival rates were encouraging, with 76% at days 28 and 60 and 71% at day 90, tracking toward an approximate 50% reduction in mortality compared to historical controls, consistent with our prior registration study.

在首批需要腎臟替代治療的 AKI 和敗血症兒科患者中，沒有發生與設備相關的不良事件、感染，也沒有免疫抑制的證據。存活率令人鼓舞，第 28 天和第 60 天的存活率為 76%，第 90 天的存活率為 71%，與歷史對照組相比，死亡率降低了約 50%，這與我們先前註冊的研究結果一致。

These early real-world data reinforced the safety profile of QUELIMMUNE and its potential to meaningfully improve outcomes in a highly vulnerable pediatric population. Ultimately, this is about giving critically ill children who would otherwise have no other options a real chance of survival.

這些早期真實世界數據強化了 QUELIMMUNE 的安全性，以及它在高度脆弱的兒科族群中顯著改善治療效果的潛力。歸根究底，這是為了讓那些身患重病、原本別無選擇的兒童獲得真正的生存機會。

Finally, expanding the pipeline of SCD indications remains a key priority for us this year. We initiated the neutralized CRS clinical trial in 2025 and are actively enrolling patients with chronic heart failure and cardiorenal syndrome. This ICU-based study is expected to enroll approximately 20 patients who are not candidates for LVAD or heart transplantation.

最後，擴大 SCD 適應症的產品線仍然是我們今年的首要任務。我們於 2025 年啟動了中和 CRS 臨床試驗，並正在積極招募患有慢性心臟衰竭和心臟腎臟綜合症的患者。這項以重症監護室為基礎的研究預計將招募約 20 名不適合接受左心室輔助裝置或心臟移植的患者。

Importantly, this trial introduces a differentiated treatment paradigm. Unlike the continuous therapy used in neutralized AKI, patients in neutralized CRS are treated intermittently, up to six hours daily for up to six days. This approach is designed to demonstrate the feasibility of intermittent SCD therapy with the potential to extend into outpatient settings and address a broader range of chronic hyperinflammatory conditions.

重要的是，這項試驗引入了一種差異化的治療模式。與中和性 AKI 中使用的持續治療不同，中和性 CRS 患者接受間歇性治療，每天最多 6 小時，持續最多 6 天。這種方法旨在證明間歇性 SCD 療法的可行性，並有可能擴展到門診環境，以解決更廣泛的慢性高發炎性疾病。

More broadly, this trial reflects our strategy to expand SCD therapy across multiple indications. Whether in AKI, CRS, or beyond, we believe our platform has the potential to meaningfully improve outcomes in patients impacted by hyperinflammation.

更廣泛地說，這項試驗體現了我們將 SCD 療法擴展到多種適應症的策略。無論是在 AKI、CRS 或其他方面，我們相信我們的平台都有潛力顯著改善受高發炎影響的患者的預後。

With that, I'll hand it over to our CFO, Mike Messinger. Mike?

接下來，我將把麥克風交給我們的財務長麥克‧梅辛格。麥克風？

Thank you, Kevin, and I'm glad everyone could join us on this call today. I'll provide a brief overview of our financial results for the fourth quarter and year-ended December 31, 2025.

謝謝你，凱文，我很高興今天大家都能參加這場電話會議。我將簡要概述我們截至 2025 年 12 月 31 日的第四季和全年財務表現。

Please note that our Form 10-K will be filed with the SEC within the next 24 hours and will include a lengthier discussion of the company's financial results for the three and 12 months ended December 31, 2025. You can find the 10-K at sec.gov or at [investors.seastarmedical.com].

請注意，我們將在未來 24 小時內向美國證券交易委員會提交 10-K 表格，其中將更詳細地討論公司截至 2025 年 12 月 31 日止三個月和 12 個月的財務業績。您可以在 sec.gov 或以下網址找到 10-K 表格：[investors.seastarmedical.com]

We recorded net revenue from QUELIMMUNE sales of approximately $315,000 for the fourth quarter of 2025 compared to $67,000 in the fourth quarter of 2024. And as Tim mentioned, we have already exceeded our fourth-quarter sales in the first quarter of 2026.

2025 年第四季度，QUELIMMUNE 的銷售淨收入約為 31.5 萬美元，而 2024 年第四季為 67,000 美元。正如蒂姆所提到的那樣，我們在 2026 年第一季的銷售額就已經超過了第四季的銷售額。

We also recognized $105,000 of net revenue this quarter from the sale of the SCD to the AREVA Research Institute. This represents the first of two orders from the Institute. If you'll recall, we announced this relationship back in June of 2025. The funding for the AREVA Research Institute's program is through a Department of Defense grant to support their cutting-edge research for extracorporeal immunomodulation to reduce inflammation after severe burns, inhalation injury, and septicemia.

本季度我們也確認了從向 AREVA 研究機構出售 SCD 中獲得的 105,000 美元淨收入。這是該研究所下達的兩份訂單中的第一份。如果你還記得的話，我們早在 2025 年 6 月就宣布了這項合作關係。AREVA 研究機構的計畫資金來自美國國防部的撥款，用於支持其利用體外免疫調節技術減少嚴重燒傷、吸入性損傷和敗血症後發炎的前沿研究。

The DoD grant covers the purchase of the SCD from SeaStar Medical for use by AREVA in its research. We anticipate a second order up to an additional $100,000. The timing of the order is uncertain, but we will report the revenue as earned in subsequent quarters.

美國國防部的撥款用於支付阿海琺公司從 SeaStar Medical 公司購買 SCD 設備，供其研究使用。我們預計會有第二筆訂單，金額最高可達 10 萬美元。訂單到貨時間尚不確定，但我們將在後續季度公佈已實現的收入。

For the full year ended December 31, 2025. QUELIMMUNE net revenue was $1.1 million compared to $135,000 of QUELIMMUNE net revenue in 2024. This increase reflects our first full year of product sales compared to only half a year in 2024. But more importantly, our expanding customer base of the top children's hospitals in the country is what drove the increase.

截至 2025 年 12 月 31 日止的整個年度。QUELIMMUNE 的淨收入為 110 萬美元，而 2024 年 QUELIMMUNE 的淨收入為 13.5 萬美元。這一增長反映了我們產品銷售的第一個完整年度，而 2024 年僅是半年。但更重要的是，我們不斷擴大的客戶群，包括全國頂尖的兒童醫院，才是推動成長的真正原因。

Turning to gross profit, our fourth-quarter and full-year statement of operations reflects a gross profit margin of greater than 90%. As a reminder, we did not recognize cost of goods sold prior to 2025, as the QUELIMMUNE units sold were originally expensed to R&D prior to approval and commercialization, which is consistent with US GAAP.

從毛利來看，我們第四季和全年的經營報表顯示毛利率超過 90%。需要提醒的是，2025 年之前我們沒有確認銷售成本，因為售出的 QUELIMMUNE 產品在獲得批准和商業化之前就已經計入研發費用，這符合美國通用會計準則。

Our operating expenses declined to $3.4 million in the fourth quarter of 2025. compared to $4.8 million in the fourth quarter of 2024. And for the full year, we reduced our operating expenses to $13.4 million compared to $18 million in the prior year. These reductions have been intentional and represent our continued discipline and our ability to leverage our team's broad experience, talent and enthusiasm to work across the organization to ensure our company's success.

2025 年第四季度，我們的營運費用下降至 340 萬美元，而 2024 年第四季為 480 萬美元。全年來看，我們的營運支出減少至 1,340 萬美元，而前一年為 1,800 萬美元。這些裁員是經過深思熟慮的，體現了我們一貫的嚴謹作風，以及我們利用團隊豐富的經驗、才能和熱情，在整個組織內開展合作，確保公司取得成功的能力。

Net loss for the fourth quarter of 2025 was approximately $2.9 million or $0.80 per share based on weighted average shares outstanding of approximately 3.6 million. This compares with a net loss of approximately $4.4 million or $8.98 per share in the fourth quarter of 2024 based on approximately 492,000 weighted average shares outstanding.

2025 年第四季淨虧損約 290 萬美元，即每股虧損 0.80 美元（按加權平均流通股約 360 萬股計算）。相較之下，根據約 49.2 萬股加權平均流通股計算，2024 年第四季淨虧損約為 440 萬美元，即每股虧損 8.98 美元。

For the full-year 2025 and 2024, net loss was $12.2 million and $24.8 million, respectively, again reflecting both the expanded adoption of QUELIMMUNE and our strong discipline in managing our expenses and reducing those expenses.

2025 年和 2024 年全年淨虧損分別為 1,220 萬美元和 2,480 萬美元，再次反映了 QUELIMMUNE 的廣泛應用以及我們在管理和降低支出方面的嚴格紀律。

Turning to our financial position, we continued to substantially improve the company's balance sheet through the addition of approximately $23.9 million in capital during 2025 and a reduction of $3.1 million in operating liabilities, and we have no long-term debt. We have approximately $12 million of cash on our balance sheet as of December 31, 2025, compared to $1.8 million at December 31, 2024.

再來看我們的財務狀況，我們透過在 2025 年增加約 2,390 萬美元的資本和減少 310 萬美元的經營負債，繼續大幅改善公司的資產負債表，並且我們沒有長期債務。截至 2025 年 12 月 31 日，我們的資產負債表上約有 1,200 萬美元現金，而截至 2024 年 12 月 31 日，現金餘額為 180 萬美元。

With that, I'll turn it back to you, Eric.

那麼，現在輪到你了，艾瑞克。

Thanks, Mike. The progress we shared with you today will propel the achievement of our milestones in 2026. We plan to further expand QUELIMMUNE adoption, advance enrollment in our neutralized AKI pivotal trial, and broaden our indications and expedite potential approvals for our STD therapy indications. We believe that the opportunities that lie ahead for SeaStar are significant, and we look forward to reporting our future progress.

謝謝你，麥克。今天我們與大家分享的進展將推動我們在 2026 年實現里程碑目標。我們計劃進一步擴大 QUELIMMUNE 的應用範圍，推進中和 AKI 關鍵性試驗的入組，並擴大適應症範圍，加速性傳染病治療適應症的潛在批准。我們相信 SeaStar 未來擁有龐大的發展機遇，我們期待向大家報告未來的進展。

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

接下來，我會請接線生開啟問答環節。操作員？

(Operator Instructions) David Botts, Zacks Small Cap Research.

（操作說明）David Botts，Zacks Small Cap Research。

So first question is about the QUELIMMUNE adoption and additional centers. You say you're targeting about 15 additional pediatric centers that you want to get the QUELIMMUNE into. So what gives you confidence that you'll be able to hit that number this year?

所以第一個問題是關於 QUELIMMUNE 收養和增設中心。你說你打算將 QUELIMMUNE 引進另外 15 家兒科中心。那麼，是什麼讓你有信心今年能夠達到這個目標呢？

Yeah, yeah. Thanks, David. This is Eric. Thanks for joining us today. Ken, why don't you tackle that?

是啊是啊。謝謝你，大衛。這是埃里克。感謝您今天收看我們的節目。肯，你為什麼不去處理這件事？

Sure. Well, thank you for the question, and I think we're starting out pretty quickly. So we've already added six sites towards that goal in the first quarter. And, you know, this -- adding sites is not -- it's a continual process and it takes time. And so we've been -- we have a very organized list of hospitals within this top 50. We've been working with many of them and we take them through the adoption process which it takes some time, but at this point, we're able to forecast, as we move forward, when we approximately think those sites will be able to become activated and become QUELIMMUNE customers.

當然。謝謝你的提問，我覺得我們起步很快。因此，我們在第一季已經朝著這個目標新增了六個站點。而且，你知道，添加網站並不是一個持續的過程，需要時間。因此，我們已經整理了一份前 50 名的醫院名單，這份名單組織得非常完善。我們一直在與他們中的許多人合作，並帶領他們完成採用過程，這需要一些時間，但目前，隨著我們不斷推進，我們能夠預測這些網站大約何時能夠啟動並成為 QUELIMMUNE 的客戶。

In addition to that, we're coming to this point around the SAVE Registry where we believe we've met the requirements of that registry. We're going to work with the FDA to review the data out of that registry. And the goal here is for us to make this registry optional versus mandatory going forward. If that happens, then we'll be able to move sites theoretically quicker through the process because a big piece of this timeline has been related to getting that registry set up and up and running.

除此之外，我們目前在 SAVE 註冊方面也達到了我們認為已經滿足該註冊要求的階段。我們將與FDA合作，審查該註冊庫中的數據。我們的目標是讓這項登記制度從強制性的變成可選的。如果這種情況發生，那麼理論上我們就能更快完成網站遷移流程，因為這個過程的很大一部分都與註冊管理機構的建立和運作有關。

So we feel good about the addition of new sites. We feel good about the forecast. We feel good in general about the momentum that we're creating with QUELIMMUNE within the pediatric community.

所以我們對新增站點感到滿意。我們對天氣預報感到樂觀。總的來說，我們對 QUELIMMUNE 在兒科領域的進展感到滿意。

Okay, great. Appreciate that. I was wondering if you could comment a little bit about the manufacturing capacity for the SCD. I don't know if it's something you need to worry about right now with the pediatric indication. But as you think ahead to the adult indication and getting approval for that, is there any type of investment that's going to be needed in order to meet the potential commercial demand there?

好的，太好了。謝謝。我想請您簡單介紹一下SCD的生產能力。我不知道就兒科適應症而言，這是否是您需要擔心的問題。但展望未來，考慮到成人適應症並獲得批准，是否需要任何類型的投資來滿足潛在的商業需求？

Yeah. David, thanks again. Great question. Yeah, we are actually very confident in the supply chain of kind of the SCD both for pediatrics as well as adults. As we have disclosed to the market, you know, our contract manufacturer is Fresenius Medical, who obviously has a deep skill and capacity to be able to produce enough SCDs for both pediatrics as well as for adults.

是的。大衛，再次感謝你。問得好。是的，我們對兒科和成人 SCD 的供應鏈都非常有信心。正如我們向市場披露的那樣，我們的合約製造商是費森尤斯醫療，他們顯然擁有深厚的技術和能力，能夠生產足夠的 SCD，既適用於兒科也適用於成人。

All right, sounds good. And then quickly on the CRS study, I don't know if you have any type of feel for timelines for that study as far as enrollment goes. And then maybe more importantly, if the study is positive, what are next steps for that indication?

好的，聽起來不錯。關於 CRS 研究，我不知道您是否了解研究在招募方面的進度安排。更重要的是，如果研究結果呈現陽性，那麼下一步該如何落實這項指標呢？

Yeah. Let me tackle that one. So we haven't really given any guidance as to when that study would be completed. What we did announce this last year is that we did initiate -- one site is now activated. We're going to continue to activate up to five sites in total.

是的。讓我來解決這個問題。因此，我們還沒有給出任何關於該研究何時完成的指導意見。我們去年宣布的一件事是，我們已經啟動了——現在一個網站已經啟用。我們將繼續啟用總共最多五個站點。

And then, I know that the teams are actively screening for patients as well. And so we'll just kind of update the market as the year kind of progresses along. At the end of the day, with a successful study, we believe that, because of the orphan nature of the small patient population for this CRS bridging the LVAD patient population, that it actually would be eligible for humanitarian device exemption, which is the same designation that we have for the pediatric, which really does allow us to get the therapy to much, you know, these much-needed patients that just really don't have any solution, but it really doesn't then require us to do a large clinical study as we're doing for the adult AKI indication.

而且，我知道各個團隊也在積極篩選患者。所以，我們會隨著時間的推移，對市場狀況進行更新。最終，我們相信，如果研究成功，由於這種 CRS 療法的患者群體較小且屬於罕見疾病，它能夠銜接 LVAD 患者群體，因此實際上符合人道主義器械豁免的條件，這與我們為兒科患者提供的豁免相同。這確實使我們能夠為更多急需治療、但目前尚無其他解決方案的患者提供治療，但同時又無需像針對成人 AKI 適應症那樣進行大規模臨床研究。

Okay. Sounds good. And then last one. Financial question here. So I guess this is for Mike. How should we think about spending for this year? Do you think it's to be more in line with this past year, 2025, or more like 2024?

好的。聽起來不錯。然後是最後一個。這裡有個財務問題。所以我想這是給麥克的。今年我們該如何規劃支出？你認為會更接近去年的情況，還是 2025 年的情況，還是更接近 2024 年的情況？

Yeah. Go ahead, Mike.

是的。請繼續，麥克。

Sure. Thanks. And thanks for joining, David, really appreciate it. So we see spending really more in line with 2025 and sort of more in line with, you know, the last quarter or so. The good thing is we have the team in place to execute this plan, both commercially as well as clinically, so you can put that into how you see the run rate going.

當然。謝謝。謝謝你的參與，大衛，非常感謝。因此，我們看到支出情況實際上更接近 2025 年的水平，也更接近上個季度左右的水平。好消息是我們已經組建了一支能夠執行這項計劃的團隊，無論是在商業上還是臨床上，所以你可以把這一點考慮在內，看看目前的進展情況。

(Operator Instructions) Anthony Vendetti, Maxim Group.

（操作說明）安東尼·文德蒂，馬克西姆集團。

So I was just wondering, so you've treated, I think, Kevin, you said treated 181 -- or enrolled 181 of the 339 target patients. How many of those 181 have gone through treatment at this point, if not all of them? And what have you learned so far from those? Anything that you could share at this point, or do you have to wait until the trial is fully enrolled at 339 and then wait for those top-line results mid-'27?

所以我想問一下，凱文，你說過你治療了 181 名患者——或者說，你招募了 339 名目標患者中的 181 名。到目前為止，這181人中有多少人接受過治療？如果不是全部的話？你從這些經驗中學到了什麼？目前有什麼可以分享的嗎？還是必須等到試驗招募到 339 位受試者後，再等到 2027 年中才能公佈初步結果？

Thanks, Anthony. Kevin, go ahead and answer the question for Anthony.

謝謝你，安東尼。凱文，請你替安東尼回答這個問題。

Yeah. Thanks, Anthony, for that question. I think clinically I'm not really able to share any lessons learned with regards to the 181 patients. What I can tell you is that of those, about half were randomized to treatment, which is in line with a randomized controlled trial.

是的。謝謝安東尼的提問。我覺得從臨床角度來說，我無法分享關於這 181 位患者的任何經驗教訓。我可以告訴你的是，其中大約一半被隨機分配到治療組，這與隨機對照試驗相符。

We have had a recent in-person investigators meeting, which was very well attended despite really storms across the country at that time. And I was very surprised to have even 70% in-person attendance and then another 25 to 30 people online. There, we were able to share best practices in terms of how we identify these patients, specific tactical targets of opportunity, ways to go about approaching and really how to talk to the family members to optimize the enrollment rate.

我們最近舉行了一次面對面的調查員會議，儘管當時全國各地都遭遇了暴風雨，但出席人數仍然很多。令我非常驚訝的是，現場出席率竟然達到了 70%，還有 25 到 30 人在線上參加。在那裡，我們分享了在識別這些患者、具體的戰術目標、接觸患者的方法以及如何與患者家屬溝通以優化入組率方面的最佳實踐。

Those kinds of best practices, really, it was very invaluable for us to share across all the sites because not all the sites are equal in terms of their experience with research and it was very valuable to us. It generated a ton of enthusiasm and also led to introduction to a variety of different other sites that we were referred to by our own investigators, PIs.

這些最佳實踐對我們來說真的非常寶貴，值得我們在所有站點之間分享，因為並非所有站點在研究經驗方面都相同，這對我們來說非常有價值。它激發了我們極大的熱情，也讓我們接觸了許多其他不同的網站，這些網站都是我們自己的研究人員、首席研究員推薦給我們的。

We're, again, I think we spoke and Eric said and we all said that we're targeting around the year-end for our enrollment. What I can say is that we're 100% committed to that, and very enthusiastic about the new sites that we've identified that will be on clinicaltrials.gov shortly once we activate them over the next quarter or so, very excited about these sites and what's to come in the next year.

我想我們之前也談過了，艾瑞克說過，我們也都說過，我們的目標是在年底前後完成招生。我可以肯定地說，我們對此百分之百投入，並且對我們已經確定的新試驗點感到非常興奮，這些試驗點將在未來一個季度左右激活後不久出現在 clinicaltrials.gov 上，我對這些試驗點以及明年即將發生的事情感到非常興奮。

Okay. So thanks for that, Kevin. That was helpful. Just in terms of maybe on the pediatric AKI side, you completed that SAVE trial. What about anything you've learned on the pediatric side in terms of QUELIMMUNE?

好的。謝謝你，凱文。那很有幫助。就兒科 AKI 方面而言，你們完成了 SAVE 試驗。您在兒科方面，特別是關於 QUELIMMUNE 方面，有什麼了解嗎？

And then in terms of being able to include another 15 top-ranked children's medical centers, are you targeting a certain number of sales reps you need to add this year? Or do you have the sales reps you need at this point? Maybe how we should think about that metric going forward.

那麼，為了能夠再納入 15 家排名靠前的兒童醫療中心，你們今年是否計劃增加一定數量的銷售代表？或者說，你現在是否已經擁有所需的銷售代表？或許我們應該這樣看待這個指標。

Okay, great. Thanks, Anthony. So Kevin, why don't you talk a little bit about maybe some of the data that we've seen from a clinical standpoint, and then Tim can answer the question around the 15 patients, the adoption.

好的，太好了。謝謝你，安東尼。那麼凱文，你能否從臨床角度談談我們看到的一些數據，然後蒂姆可以回答關於 15 名患者和採用情況的問題。

Right. Thank you, Anthony, for that question. I mean, the paper speaks for itself. What is not completely obvious to folks that are not in the community of taking care of pediatric nephrology and critical care patients is that all these patients were essentially at death's door and were out of options. And the fact that we were able to have over 70% of them alive at 90 days is, to me, a mini miracle.

正確的。謝謝你，安東尼，提出這個問題。我的意思是，論文本身就能說明一切。對於不從事兒科腎臟病和重症監護病人護理的人來說，不太明顯的是，所有這些病人實際上都已瀕臨死亡，並且沒有其他治療選擇。90 天后，我們能夠保證超過 70% 的動物存活下來，在我看來，這簡直是個小奇蹟。

To be able to replicate the data that were submitted to the FDA is strong. But for me, this was surprising given the fact that this was a sicker population. And once we are able to report all 50, you will see how sick these patients really are compared to even prior to commercialization.

能夠復現提交給FDA的數據，這一點非常有力。但對我來說，考慮到這部分族群的健康狀況較差，這個結果令人驚訝。一旦我們能夠報告全部 50 例病例，您就會看到與商業化之前相比，這些患者的病情究竟有多嚴重。

One thing that is interesting is that whenever life-saving technology is introduced to the market, I have personal experience initiating a CRRT capability, you know, initially 20 years ago, and then ECMO. Those technologies are usually given and provided and offered only to the sickest of the sick as a last resort, and oftentimes outcomes are not as good as what you would think because you're applying them to dying patients.

有趣的是，每當有救生技術被引入市場時，我都有親身經歷去啟動 CRRT 能力，你知道，最初是在 20 年前，然後是 ECMO。這些技巧通常只作為最後的手段提供給病情最嚴重的病人，而且由於是應用於垂危病人，其結果往往不如你想像的那麼好。

Well, what we're seeing -- what we've seen is something that is very miraculous, at least personally, from a professional and personal standpoint. I'm very, very pleased with this outcome. It shows that it was worthwhile to enter the pediatric market first, and we're saving lives, and that's what we're all about.

我們所看到的——我們所看到的，至少從專業和個人角度來看，是非常神奇的事。我對這個結果非常非常滿意。這顯示我們當初進入兒科市場是值得的，我們正在拯救生命，而這正是我們工作的意義。

Yeah. No, the results are obviously very compelling. Okay, Tim, on the sales front.

是的。不，結果顯然非常令人信服。好的，提姆，關於銷售方面。

Sure, sure, Anthony. The short answer to your question is no, we're not adding additional salespeople to the effort.

當然，當然，安東尼。簡而言之，答案是否定的，我們不會增加銷售人員。

As mentioned, we're exclusively focused on the top 50 pediatric hospitals, and that is the highest volume for us patient-wise. We're expecting to add an additional 15. We have 6 already through the first quarter. and we have others moving through process.

如前所述，我們只專注於排名前 50 名的兒科醫院，就病患數量而言，這是我們服務範圍最廣的醫院。我們預計還會增加15人。第一季我們已經完成了6個項目，還有其他項目正在處理中。

What we do expect to do is increase our overall -- our clinical representation within those hospitals. So having onsite clinical representation to really expand the footprint within these institutions. One thing -- this is a continual learning process for us, obviously. And what we're learning is we have great momentum and we need to continue to enhance that by getting to these educational opportunities within these institutions so that there's more general knowledge about QUELIMMUNE within the institutions that we work with that more folks and staff, that patient care teams and physicians that work in these institutions understand what QUELIMMUNE is, understand the type of patient to use it for, how to profile that patient, and ultimately the best way to use it to be successful.

我們希望提高我們整體的—我們在這些醫院的臨床代表性。因此，配備現場臨床代表可以真正擴大在這些機構中的影響力。有一點——這顯然對我們來說是一個持續學習的過程。我們發現，我們擁有巨大的發展勢頭，我們需要繼續加強這種勢頭，透過在這些機構內提供教育機會，讓與我們合作的機構對 QUELIMMUNE 有更全面的了解，讓更多的人員、工作人員、患者護理團隊和醫生了解 QUELIMMUNE 是什麼，了解它適用於哪種類型的患者，如何對患者進行評估，以及最終如何成功地使用它。

The other thing we're doing too is we have a great relationship with this community. And one result of that is the Advanced Practice Provider Advisory Board that we've put together. As I mentioned, they're going to be active at the symposium at AKI CRRT later this week. And the momentum there is significant as well. So in essence, we have evangelists that are within the customer base that really believe in this product the same way we do, and we're going to enhance that by working with them as closely as possible as well.

我們也與這個社區建立了良好的關係。由此產生的成果之一就是我們組成了高階實務提供者顧問委員會。正如我之前提到的，他們將在本週晚些時候舉行的 AKI CRRT 研討會上積極參與。而且這方面的勢頭也相當強勁。所以本質上，我們在客戶群中擁有一些忠實擁護者，他們和我們一樣真正相信這款產品，我們將透過盡可能與他們緊密合作來加強這種氛圍。

Thank you. I would now like to turn the call back over to Jackie Cossmon for any closing remarks.

謝謝。現在我想把電話轉回給傑基·科斯蒙，請她做總結發言。

Thank you, Josh. And thank you all for joining us today for the SeaStar Medical fourth-quarter and year-end financial results conference call.

謝謝你，喬希。感謝各位今天參加 SeaStar Medical 第四季及全年財務業績電話會議。

If you have questions, please contact us at ir.seastarmed.com or visit our website at www.seastarmedical.com. Thank you and goodbye.

如有任何疑問，請透過 ir.seastarmed.com 聯絡我們，或造訪我們的網站 www.seastarmedical.com。謝謝，再見。

Thank you. This concludes the conference. Thank you for your participation. You may now disconnect.

謝謝。會議到此結束。感謝您的參與。您現在可以斷開連線了。