SeaStar Medical Holding Corp (ICU) 2025 Q3 法說會逐字稿

Good day and thank you for standing by. Welcome to the SeaStar Medical third quarter Final results conference call. At this time, (Operator Instructions) Please be advised that today's conference is being recorded.

您好，感謝您的耐心等待。歡迎參加SeaStar Medical第三季最終業績電話會議。（操作員指示）請注意，今天的會議正在錄音。

I'll like to hand the conference over to your first speaker today, Jackie Cosman. Please go ahead.

我謹將會議交給今天的第一位發言人，傑基·科斯曼。請繼續。

Thank you, Marvin. Good afternoon and thank you for joining the SeaStar Medical Third quarter 2025 Financial Results conference call. I'm Jackie Cossmon with Wheelhouse Life Science Advisors. Joining me from SeaStar Medical today are Eric Schlorff, Chief Executive Officer, Dr. Kevin Chung, Chief Medical Officer, Tim Varacek, senior Vice President of commercial and Business Operations, and Brad Town, our Controller.

謝謝你，馬文。下午好，感謝各位參加SeaStar Medical 2025年第三季財務業績電話會議。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 Sc​​hlorff、首席醫療官 Kevin Chung 博士、商業和業務營運高級副總裁 Tim Varacek 以及財務總監 Brad Town。

I would like to remind listeners that comments made during this call by management will include forward-looking statements within the meaning of federal securities laws. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from any anticipated results. For a list and description of these risks and uncertainties, please review SeaStar Medical's filings with the Securities and Exchange Commission.

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。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。

Furthermore, the content of this conference call contains information that is accurate only as of the date of the live broadcast, November 13, 2025. Seasar Medical undertakes no obligation to revise or update any statements to reflect events or circumstances except as required by law.

此外，本次電話會議的內容所包含的資訊僅在直播當天（2025 年 11 月 13 日）是準確的。除法律要求外，Seasar 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.

現在，我想把電話交給艾瑞克。

Thank you, Jackie, and thank you all for joining us today. Since the beginning of the third quarter, we advanced our business on several fronts that we believe position us well for our future growth. We added top three ranked children's medical centers to our growing customer base and also reported very impressive survival results for the use of the immune therapy in the treatment of 21 paediatric patients in a commercial setting.

謝謝傑基，也謝謝各位今天蒞臨現場。自第三季初以來，我們在多個方面推進了業務發展，我們相信這將使我們為未來的成長奠定良好的基礎。我們新增了排名前三名的兒童醫療中心，並擴大了客戶群。此外，我們也報告了在商業環境下使用免疫療法治療 21 名兒科患者所取得的非常令人矚目的生存結果。

These remarkable data, which Kevin will cover, came from the Save surveillance registry that was presented at the 5th International Symposium on acute kidney injury in Children in the last week of September 2025. While the requirement for this registry has hampered our ability to add sites quickly, the data in hand continues to demonstrate the value of the therapy and has been very useful in helping our target customers see the benefits of the immune therapy in the commercial setting.

Kevin 將要介紹的這些非凡數據來自 Save 監測登記處，該登記處於 2025 年 9 月最後一周在第五屆國際兒童急性腎損傷研討會上發表。雖然註冊要求阻礙了我們快速添加網站的能力，但現有數據繼續證明了該療法的價值，並且對於幫助我們的目標客戶在商業環境中了解免疫療法的益處非常有幫助。

With respect to our QUELIMMUNE revenue, in the third quarter, we reported net revenue of 183,000. Importantly, as we've mentioned, our sales continue to be a bit variable from quarter to quarter. If we look at the six months ended September 30th versus six months ended March 30th, our revenue is up 45%. And we believe with new sites and new data on immune use in the commercial market, we are gaining traction. In fact, in the first half of the fourth quarter, QUELIMMUNE orders are already exceeding the entire third quarter. In short, we are anticipating full year revenue for the 2025 will be over a million dollars. This provides a strong foundation for growth into 2026, and Tim will describe some additional measures we have taken on the sales front.

關於我們的 QUELIMMUNE 收入，第三季我們報告的淨收入為 183,000。重要的是，正如我們之前提到的，我們的銷售額每季都會有些波動。如果我們比較截至 9 月 30 日的六個月和截至 3 月 30 日的六個月，我們的收入成長了 45%。我們相信，隨著新站點的建立和商業市場中免疫應用新數據的出現，我們正在取得進展。事實上，在第四季上半年，QUELIMMUNE 的訂單量已經超過了整個第三季的訂單量。簡而言之，我們預計 2025 年全年收入將超過一百萬美元。這為 2026 年的成長奠定了堅實的基礎，蒂姆將介紹我們在銷售方面採取的一些其他措施。

In the third quarter we also reported our first full quarter of cost of goods for product sales with a gross profit margin of 92%, which is similar to a branded pharmaceutical product, along with a clear value proposition for hospital systems to save money using QUELIMMUNE. We believe this affords us an opportunity to generate future cash, reducing the amount of cash we need to raise to fund operations.

第三季度，我們也公佈了產品銷售的第一季完整商品成本，毛利率為 92%，與品牌藥品類似，同時明確表明，使用 QUELIMMUNE 可以為醫院系統節省資金。我們相信這將為我們創造未來的現金流，從而減少我們為營運籌集資金所需的現金量。

Now turning our efforts on the neutralize AKI trial, we completed the interim analysis, enabling us to understand early safety data and trends toward efficacy for our neutralized AKI pivotal trial of the selective Cytopheretic device, or SCD therapy. We also continue to add clinical sites to ensure we meet our new enrolment targets for the trial.

現在，我們將精力轉向中和 AKI 試驗，我們完成了中期分析，從而能夠了解選擇性細胞分離裝置（或 SCD 療法）中和 AKI 關鍵試驗的早期安全性數據和療效趨勢。我們也會繼續增加臨床試驗點，以確保達到試驗的新入組目標。

In addition, we also announced today that we have opened the first site for the neutralized CRS clinical trial of the STD therapy to treat patients with acute chronic systolic heart failure with cardio renal syndrome or CRS awaiting left ventricular assist device or LVAD implant plantation. This is a small but very important market opportunity as it would potentially demonstrate the value of the STD therapy in an indication outside of AKI supporting its broad applications in many destructive hyperinflammation conditions.

此外，我們今天還宣布，我們已開設了第一個中和 CRS 的 STD 療法臨床試驗點，用於治療患有急性慢性收縮性心臟衰竭伴心腎綜合徵 (CRS) 且等待左心室輔助裝置 (LVAD) 植入的患者。這是一個雖小但非常重要的市場機會，因為它有可能證明 STD 療法在 AKI 以外的適應症中的價值，從而支持其在許多破壞性過度發炎疾病中的廣泛應用。

Finally, we continued our disciplined effort to reduce costs while achieving strong operational results, and we raised over $12 million to strengthen our balance sheet and extend our financial runway. Now before I turn the call over to Tim, I'd like to emphasize one last point.

最後，我們繼續有條不紊地努力降低成本，同時取得了強勁的營運業績，並籌集了超過 1200 萬美元，以增強我們的資產負債表並延長我們的財務緩衝期。在把電話交給蒂姆之前，我想強調最後一點。

That is, the data we see and the stories we hear about how quell immune therapy has saved the lives of critically paediatric patients who in most cases have little hope of survival are what drives our efforts to expand the use of this therapy to more children and to adults with similar conditions caused by destructive hyperinflammation. These market opportunities are significant, and we are working diligently to bring our life saving therapy to the patients whose chances of survival due to hyperinflammation are otherwise limited.

也就是說，我們看到的數據和聽到的故事，講述了抑制免疫療法如何拯救了大多數情況下幾乎沒有生存希望的危重兒科患者的生命，正是這些推動著我們努力將這種療法的使用範圍擴大到更多兒童和患有類似疾病（由破壞性過度炎症引起）的成人。這些市場機會意義重大，我們正在努力將我們的救命療法帶給那些因過度發炎而生存機會有限的患者。

And now I will turn the call over to Tim to discuss our commercial achievements and market opportunities.

現在我將把電話交給提姆，讓他來討論我們的商業成就和市場機會。

Thanks, Eric, and thanks everyone for joining us today on the SeaStar Medical third quarter call. Our goal for the QUELIMMUNE launch this year has been to activate up to 20 new pediatric hospitals to drive product revenue, and as the number of centers increase to provide a predictable stream of revenue as we move into 2026 and beyond. We currently have 10 active commercial pediatric hospitals that have completed all IRB approvals and have ordered product, adding 4 new customers since the beginning of the third quarter. We're working diligently to increase that number and expect additional new sites to be added by the end of this year.

謝謝艾瑞克，也謝謝各位今天參加 SeaStar Medical 第三季電話會議。今年 QUELIMMUNE 的上市目標是啟動多達 20 家新的兒科醫院，以推動產品收入，隨著中心數量的增加，我們將在 2026 年及以後提供可預測的收入流。目前我們有 10 家活躍的商業兒科醫院已完成所有 IRB 批准並訂購了產品，自第三季初以來新增了 4 位客戶。我們正在努力增加這個數字，預計到今年年底將新增更多站點。

As Eric indicated, our fourth quarter product sales in the 1st 6 weeks already position us for revenue exceeding the third quarter net revenue. And it's important to note that we've seen an uptick in patients receiving qua immune therapy. Our focus for the remainder of the year and into 2026 is to ensure all clinically appropriate patients receive qua immune therapy.

正如艾瑞克所指出的，我們第四季前 6 週的產品銷售額已經使我們的收入超過了第三季的淨收入。值得注意的是，我們發現接受 qua 免疫療法的患者人數增加。今年剩餘時間和 2026 年，我們的重點是確保所有臨床上合適的患者都能接受 qua 免疫療法。

Accounts and continue to move sites through immune, the Aqua immune adoption process as quickly as possible. Specifically, we continue to leverage best practices learned throughout the launch of QUELIMMUNE to implement tactics related to brand awareness, clinical performance, and patient identification, such as supplemental clinical training, development of a speaker's bureau, and development of a patient care team forums to share ideas and overcome operational challenges typical to new product adopt adoption within hospital systems.

帳戶並繼續透過免疫方式遷移站點，Aqua 免疫採用流程應盡快完成。具體而言，我們將繼續利用 QUELIMMUNE 上市過程中學到的最佳實踐，實施與品牌知名度、臨床表現和患者識別相關的策略，例如補充臨床培訓、建立演講者名冊以及建立患者護理團隊論壇，以分享想法並克服醫院系統採用新產品時常見的運營挑戰。

We've been able to leverage clinical and economic data as well through recent publications such as the cost savings model published in the Journal of Medical Economics and real-world data presentation. From our patient registry illustrating the survival benefit of qua immune therapy when added to CRRT in pediatric AKI. Importantly, we believe that the patient population for this therapy is far broader than it's used today.

我們還能夠利用臨床和經濟數據，例如最近發表在《醫學經濟學雜誌》上的成本節約模型和真實世界數據展示。我們的患者登記數據顯示，在兒童急性腎損傷 (AKI) 的 CRRT 治療中加入免疫療法可提高存活率。重要的是，我們認為這種療法的適用人群比目前使用的患者群體要廣泛得多。

Beyond expanding use in our active accounts, we are working to remove hurdles to the adoption process for new target accounts. While the high-level process to qua immune adoption is the same for all hospital systems, how these sites work through the process can vary and how they are structured from a clinical care and administrative perspective.

除了擴大現有帳戶的使用範圍外，我們還在努力消除新目標帳戶採用過程中的障礙。雖然所有醫院系統採用免疫療法的整體流程相同，但這些機構如何完成流程以及從臨床護理和管理角度來看它們的結構可能會有所不同。

We continue to refine the operational process of QUELIMMUNE adoption and attempt to simplify this process for the customer, for example, Before we have our first meeting with the new system interested in Qual immune, we diligently work to identify and include key staff such as nephrology, critical care, nursing, procurement, research, and many more. This may sound obvious, but in many cases, the primary investigator and advocate sponsoring QUELIMMUNE for their system.

我們不斷改進 QUELIMMUNE 的採用流程，並努力簡化客戶的流程。例如，在與對 Qual immune 感興趣的新系統進行第一次會議之前，我們會認真地確定並邀請腎臟科、重症監護、護理、採購、研究等關鍵人員參與。這聽起來可能很明顯，但在許多情況下，主要研究者和倡導者會為他們的系統贊助 QUELIMMUNE。

Isn't fully aware of these staff members. Getting these people in a conference with us all at the same time ultimately shortens the adoption curve as we are able to identify point people, share cross-functional requirements, and allocate specific tasks to be completed in parallel. It is a symphony at work with many role players, and the good news is that we are beginning to see an impact of these efforts, and we recently were able to add a leading pediatric institution in a six month time frame. While still not the norm, it's great progress, and everything we learn in this launch will benefit SeaStar Medical and future commercial launches as well.

對這些工作人員並不完全了解。讓這些人同時與我們開會，最終可以縮短採用曲線，因為我們能夠確定負責人，共享跨職能需求，並分配要並行完成的具體任務。這是一個由眾多參與者共同協作的交響樂，好消息是我們已經開始看到這些努力的影響，最近我們在六個月的時間裡成功引進了一家領先的兒科機構。雖然這還不是常態，但這已經是巨大的進步，我們在此次發布中學到的一切都將使 SeaStar Medical 和未來的商業發布受益。

And finally, with our early registry data in hand, we have approached the FDA to request relief from the mandatory registry. We are very hopeful that the FDA will agree to this request and believe they will be aligned with accelerating adoption of QUELIMMUNE to potentially save more lives.

最後，憑藉我們掌握的早期註冊數據，我們已向 FDA 提出申請，請求豁免強制性註冊。我們非常希望 FDA 能夠同意這項請求，並相信他們會支持加速採用 QUELIMMUNE，從而有可能挽救更多生命。

Now turning to the market, we have great expectations for 2026 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 revenue stream for our investors and Seastar Medical. That's our goal.

現在展望市場，我們對 2026 年寄予厚望，希望透過向更多兒科醫院系統提供 QUELIMMUNE 療法來幫助患者。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。這就是我們的目標。

We believe that we will capture a sizable portion of this small but important market, and our estimates put the total US market at about $100 million and capturing even a small double-digit percent of this market creates significant value for our stockholders and delivers important revenue for Seasar Medical.

我們相信，我們將在這個雖小但重要的市場中佔據相當大的份額，據我們估計，美國市場總規模約為 1 億美元，即使只佔據兩位數的市場份額，也能為我們的股東創造巨大的價值，並為 Seasar Medical 帶來重要的收入。

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 thank you to everyone joining us today. I'm pleased to report continued momentum in our neutralized AKI pivotal trial. Since the start of Q3, we've onboarded three additional clinical sites and enrolled 21 more patients, bringing a total enrolment to 146 of our new targets of 339 patients. For those less familiar, neutralized AKI is a 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 CRRT.

謝謝提姆，也謝謝今天所有到場的各位。我很高興地報告，我們針對 AKI 的中和關鍵性試驗取得了持續進展。自第三季開始以來，我們新增了三個臨床中心，並招募了 21 名患者，使總入組人數達到 146 人，距離我們新的 339 名患者的目標還有一段距離。對於不太熟悉的人來說，中和 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 CRRT 的急性腎損傷危重患者的 90 天生存率或腎功能恢復。

The primary endpoint is a composite of mortality or dialysis dependence at 90 days. As planned, we conducted a pre-specified interim analysis at the 100-patient milestone to assess safety and confirm our statistical powering assumptions. I am pleased to share that the Independent Data Safety Monitoring Board or DSMB determined the STD therapy to be safe with no device-related adverse events observed in the treatment arm. This finding is particularly important in the ICU setting, where patients are often critically ill, immune compromised, and subject to multiple organ support modalities.

主要終點是 90 天內死亡或需要透析的複合終點。按照計劃，我們在達到 100 名患者里程碑時進行了預先指定的期中分析，以評估安全性並確認我們的統計功效假設。我很高興地宣布，獨立資料安全監察委員會（DSMB）認定性傳播疾病治療是安全的，治療組中未觀察到與設備相關的不良事件。這項發現對於重症監護室來說尤其重要，因為那裡的患者通常病情危重、免疫功能低下，並且需要多種器官支持治療。

In this fragile population, even minor safety concerns can have serious clinical consequences, and they often become gating factors for regulatory review and clinical adoption. That is why demonstrating a clean safety profile is not just a trial milestone, but a critical foundation for physician confidence, FDA interaction, and future uptake in real world care. We're encouraged that STD continues to show this level of safety in such high risk environments.

在這個脆弱的族群中，即使是輕微的安全問題也可能造成嚴重的臨床後果，並且往往成為監管審查和臨床應用的阻礙因素。因此，證明其安全性良好不僅是試驗的一個里程碑，更是醫生信心、與 FDA 互動以及未來在真實世界醫療中應用的關鍵基礎。我們感到欣慰的是，STD 在如此高風險的環境中仍然展現出如此高的安全性能。

As we have previously disclosed, the interim analysis revealed that the assumed effect size of 20% was not observed at this point. While there was a clear signal of clinical benefit, it was not large enough to achieve statistical significance with the originally planned sample size of 200. Based on this, in accordance with the trial's statistical analysis plan, the DSMB recommended increasing the total enrolment to 339 patients to ensure adequate power to detect meaningful efficacy.

正如我們之前披露的那樣，中期分析顯示，目前尚未觀察到預期的 20% 的效果量。雖然有明顯的臨床獲益訊號，但由於最初計劃的樣本量為 200，因此該訊號不足以達到統計學意義。基於此，根據試驗的統計分析計劃，資料安全監察委員會建議將總入組人數增加到 339 名患者，以確保有足夠的統計效力來檢測有意義的療效。

Let me be clear, the DSMB observed a clear and encouraging signal of benefit. The recommendation to expand enrolment is a positive step forward, grounded in data and consistent with our commitment to rigorous clinical science. By increasing the sample size, we are enhancing the statistical power of the study and positioning ourselves to generate results that are more robust, more credible, and more likely to drive regulatory and clinical acceptance.

讓我明確一點，資料安全監測委員會觀察到了一個明確且令人鼓舞的益處訊號。擴大招生範圍的建議是一個積極的進步，它有數據支持，也符合我們對嚴謹臨床科學的承諾。透過增加樣本量，我們提高了研究的統計效力，並使我們能夠得出更穩健、更可信、更有可能獲得監管和臨床認可的結果。

This is a strategic recalibration and one that strengthens our confidence in the ultimate success of the trial. We have already acted on the DSMB's recommendation. In addition to our 17 active sites, we have begun activating 8 more centers to help us meet our new target. Our team, along with our academic and clinical partners is working with urgency and precision. We understand what's at stake. And we are committed to completing enrolment by the end of 2026.

這是一次策略調整，增強了我們對試驗最終成功的信心。我們已經根據資料安全監測委員會的建議採取了行動。除了我們現有的 17 個活躍站點外，我們還開始啟用另外 8 個中心，以幫助我們實現新的目標。我們的團隊與學術界和臨床界的合作夥伴正以緊迫感和精準度開展工作。我們明白事關重大。我們承諾在 2026 年底前完成招生工作。

Let me now turn to our Save surveillance registry, which tracks commercial use of QUELIMMUNE therapy in critically ill children. At the recent 5th International Symposium on acute kidney injury in Children, we presented encouraging early results from 21 pediatric patients treated under real-world conditions for life threatening AI and sepsis. Among these high-risk patients, many treated as a last resort, 76% survived through 60 days and 71% through 90 days.

現在讓我來介紹一下我們的 Save 監測登記系統，該系統追蹤 QUELIMMUNE 療法在重症兒童中的商業應用。在最近舉行的第五屆兒童急性腎損傷國際研討會上，我們展示了 21 名在真實世界條件下接受危及生命的急性腎損傷和敗血症治療的兒科患者的令人鼓舞的早期結果。在這些高風險患者中（其中許多是作為最後的治療手段），76% 的患者存活了 60 天，71% 的患者存活了 90 天。

As a critical care physician, I find these outcomes remarkable. These were children on the brink of death. While the numbers are still small, the signal is undeniable. QUELIMMUNE is giving these patients a fighting chance. These clinical data, coupled with our previous clinical study data we originally submitted to the FDA now totals 43 children with over 75% survival, clearly demonstrating the value of the therapy.

作為一名重症監護醫生，我認為這些結果非常出色。這些孩子當時都瀕臨死亡。雖然數字仍然很小，但訊號是不容否認的。QUELIMMUNE 為這些患者帶來了一線生機。這些臨床數據，加上我們先前提交給 FDA 的臨床研究數據，現在共有 43 名兒童，存活率超過 75%，清楚證明了該療法的價值。

I would also like to share a unique aspect of how we are learning from the real world use of Qune. Every month we host a Qualmmune user's call. A forum attended by both current and prospective clinical users. During these sessions, we have discussed nearly every patient treated under the same, surveillance registry. The story shared of our device stabilizing a critically ill child, in many cases reversing acute decompensation, are not only clinically powerful but deeply meaningful to all of us at SeaStar Medical.

我還想分享一下我們從 Qune 的實際應用中學習到的一個獨特方面。我們每個月都會舉辦一次 Qualmmune 用戶電話會議。現有臨床使用者和潛在臨床使用者均參加了此次論壇。在這些會議中，我們討論了在同一監測登記系統下接受治療的幾乎所有患者。我們的設備穩定了重症兒童的病情，在許多情況下逆轉了急性失代償，這個故事不僅具有強大的臨床意義，而且對我們 SeaStar Medical 的所有人來說也意義非凡。

These discussions are not just anecdotal. They provide critical insights that complement our registry data and inform best practices. At the same time, we're continuing to share pooled outcomes with the broader pediatric nephrology and critical care communities. These real world results are more than encouraging. They reinforce both the life saving potential of our therapy and the mission that drives our entire organization.

這些討論並非只是軼事。它們提供了重要的見解，補充了我們的註冊數據，並為最佳實踐提供了資訊。同時，我們繼續與更廣泛的兒科腎臟病學和重症監護界分享總結結果。這些實際結果令人鼓舞。它們既強化了我們療法的救命潛力，也強化了我們整個組織的使命。

Lastly, I'd like to highlight the launch of our neutralized CRS trial. Which evaluates STD in patients with chronic systolic heart failure complicated by cardio renal syndrome, who are not candidates for heart transplant or even LVAD or left ventricular assist device.

最後，我想重點介紹一下我們啟動的中和性 CRS 試驗。該研究評估了患有慢性收縮性心臟衰竭並伴有心腎綜合徵的患者的STD情況，這些患者不適合進行心臟移植，甚至不適合植入左心室輔助裝置（LVAD）。

The single arm feasibility study will enrol 20 patients in the ICU setting with the goal of demonstrating improvement in renal and cardiac function prior to any mechanical support intervention. One of the main differences in this treatment is the length of STD treatment versus the neutralized AKI study. These patients are treated intermittently for up to 6 hours daily for up to 6 days.

這項單臂可行性研究將在重症監護室招募 20 名患者，目標是在任何機械支持幹預之前證明腎臟和心臟功能的改善。該療法的主要區別之一是 STD 治療的持續時間與中和 AKI 研究的持續時間不同。這些患者每天接受間歇性治療，每次最多 6 小時，持續最多 6 天。

In the neutralized AKI study, the patients are treated continuously for 24 hours daily for up to 10 days. This is important because this could demonstrate the feasibility of intermittent therapy bridging to more outpatient settings. And a broad range of chronic hyperinflammatory diseases.

在中和 AKI 研究中，患者每天 24 小時持續接受治療，最多持續 10 天。這很重要，因為這可以證明間歇性治療過渡到更多門診治療的可行性。以及多種慢性發炎性疾病。

If successful, neutralized CRS could pave the way for a separate marketing application to the FDA. Opening the door to a new acute therapeutic intervention with a different dosing regimen while setting the foundation towards entry into chronic conditions in outpatient-based therapy.

如果成功，中和 CRS 可能會為向 FDA 提交單獨的上市申請鋪平道路。為採用不同給藥方案的新型急性治療介入措施打開大門，同時為進入以門診為基礎的慢性病治療奠定基礎。

As Eric noted earlier, this trial is part of our broad strategy to bring STD therapy to multiple indications, whether in AKI, CRS, or beyond. We believe our platform has the potential to transform outcomes in all patients impacted by hyperinflammation.

正如艾瑞克之前提到的，這項試驗是我們廣泛策略的一部分，旨在將 STD 療法應用於多種適應症，無論是 AKI、CRS 還是其他方面。我們相信，我們的平台有潛力改變所有受發炎過度影響的患者的治療結果。

With that, I'll hand it over to our controller Brad Town.

接下來，我將把麥克風交給我們的財務主管布拉德湯恩。

Thank you, Kevin, and thank you all for joining us today. I'll provide a brief overview of our financial results for the third quarter. Please note that a Form 10 will be filed with the SEC in the next 24 hours and we'll include a more lengthy discussion of the company's financial results for the 3 and 9 months ended September 30, 2025.

謝謝你，凱文，也謝謝各位今天蒞臨現場。我將簡要概述我們第三季的財務表現。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 表格，其中將包含對公司截至 2025 年 9 月 30 日的 3 個月和 9 個月財務業績的更詳細討論。

You can find the 10-Q at seastarmedical.com or at SEC.gov. We recorded net revenue from uilimmune sales of approximately $183,000 for the third quarter of 2025 compared to $68,000 in the third quarter of 2024. As Eric mentioned, we are already seeing a nice uptick in sales for the 1st 6 weeks of the fourth quarter.

您可以在 seastarmedical.com 或 SEC.gov 上找到 10-Q 表格。我們 2025 年第三季來自 uilimmune 銷售的淨收入約為 183,000 美元，而 2024 年第三季為 68,000 美元。正如艾瑞克所提到的，第四季前六週的銷售額已經出現了不錯的成長。

Turning to gross profit The Q3 financial statements reflect a gross profit margin of approximately 92% and as Eric indicated, represents the first full quarter of matching cost of goods sold against culling in unit sales. We did not recognize cost of goods sold for the three months ended September 30th, 2024, as QUELIMMUNE units sold were originally expensed to research and development upon acquisition, which is prior to our commercialization of QUELIMMUNE and consistent with US GAAP.

再來看毛利，第三季財務報表顯示毛利率約為 92%，如 Eric 所指出的，這是銷售成本與單位銷售量相符的第一個完整季度。截至 2024 年 9 月 30 日止的三個月，我們沒有確認銷售成本，因為售出的 QUELIMMUNE 產品在收購時已計入研發費用，這發生在 QUELIMMUNE 商業化之前，並且符合美國通用會計準則。

Operating expenses declined to $3.7 million in the third quarter of 2025 compared to $4.5 million in the third quarter of 2024. The decline was primarily due to decreased consulting expenses and personnel costs, partially offset by increased clinical research and development expenses and increased audit fees. And finally, Net loss for the third quarter was approximately $3.5 million, or $0.13 per share on approximately $26.4 million weighted average shares outstanding. This compares with a net loss of approximately $4.5 million or $1.10 per share on approximately $4.1 million weighted average shares outstanding for the third quarter of 2024.

2025 年第三季營運費用下降至 370 萬美元，而 2024 年第三季為 450 萬美元。下降的主要原因是諮詢費用和人員成本減少，但部分被臨床研發費用增加和審計費用增加所抵銷。最後，第三季淨虧損約 350 萬美元，即每股虧損 0.13 美元，加權平均流通股數約為 2,640 萬股。相較之下，2024 年第三季淨虧損約 450 萬美元，即每股虧損 1.10 美元，當時加權平均流通股約 410 萬股。

Cash at September 30, 2025, was 13.8 million compared to 1.8 million at December 31, 2024. During the three months ended September 30, 2025, the company raised $12.4 million from equity offerings and from the exercise of 2.8 million warrants.

截至 2025 年 9 月 30 日，現金餘額為 1,380 萬，而截至 2024 年 12 月 31 日，現金餘額為 180 萬。截至 2025 年 9 月 30 日的三個月內，該公司透過股權發行和行使 280 萬張認股權證籌集了 1,240 萬美元。

With that, I'll turn the call back to Eric.

這樣，我就把電話轉回給艾瑞克了。

Thanks, Brad. Our goal today for our third 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 for SeaStar Medical are significant. 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. Our goal over the coming months is to ensure that investors understand the value of the company and the future opportunities.

謝謝你，布拉德。我們今天召開第三季財務業績電話會議的目標是向大家概述我們的進展，並清楚地說明為什麼我們認為 SeaStar Medical 的未來機會十分重大。我們熱切希望能夠為重症患者提供拯救生命的療法，因為目前沒有其他治療方法可以平息過度活躍的免疫系統引起的細胞激素風暴。未來幾個月，我們的目標是確保投資者了解公司的價值和未來的發展機會。

To that end, we'll be attending a number of upcoming conferences and also meeting with investors during the week of the JPMorgan conference in San Francisco from January 12th to the 15th. We hope to see some of you there. We believe that the opportunities that lie ahead for CSTA are significant, and we look forward to reporting our future progress. With that,

為此，我們將參加一系列即將舉行的會議，並在1月12日至15日在舊金山舉行的摩根大通會議期間與投資者會面。我們希望在那裡見到你們中的一些人。我們相信 CSTA 未來將迎來重大機遇，我們期待著報告未來的進展。就這樣，

I'll ask the operator to open the call for questions. Operator.

我會請接線生開啟問答環節。操作員。

(Operator Instructions) Anthony Vendetti, Maximum Group - Analyst

（操作說明）安東尼·文德蒂，Maximum Group - 分析師

Thank you. Yeah, so I just wanted to. Get an update. I may have missed it if you gave it out, so as of.

謝謝。是的，我就是想這麼做。獲取最新消息。如果你已經分發過了，我可能就錯過了，所以截至目前為止。

September 24th. 137 of the now required I guess they right the data 50 monitoring board review board recommended 339 up from 200 back in September so. 137 were enrolled as of then. How many? What's the number as of today? And then it was 16 of the 22 to 25 sites. Had been activated. What's that number as of today? And do you feel things are tracking, as you expected, since the September change in the Enrollment number?

9月24日。現在需要137人，我猜他們把資料改正了。 50個監測委員會審查委員會建議339人，比9月的200人增加。所以，截至當時，已有137人登記。多少？截至今天，這個數字是多少？然後，22 到 25 個站點中有 16 個出現了問題。已啟動。截至今天，這個數字是多少？自從9月入學人數改變以來，您是否覺得事情進展如您所預期的？

Hey Anthony, this is Eric. Go ahead, Eric.

嗨，安東尼，我是艾瑞克。請繼續，埃里克。

Hey Kevin.

嘿，凱文。

Yeah, hi, Anthony. Thanks, Eric. So, thanks for that question. We are currently at 146, patients enrolled. We, have 17 sites activated. And as I just recently covered, we are moving forward with the activation of at least 8 additional sites, so that'll get us to about 25 sites. And we're hoping to look for more sites, and the selection criteria are pretty stringent. I'm looking for champions who are going to take ownership of the trial within their site. Screening is not easy. Selecting patients and getting patients enrolled is not easy, so we need the right site with the right investigators with the right teams in order to have success.

嗨，安東尼。謝謝你，埃里克。謝謝你的提問。目前已有 146 名患者入組。我們目前已啟用17個站點。正如我最近報導的那樣，我們正在推進至少 8 個新站點的啟用，這樣一來，我們的站點總數將達到約 25 個。我們希望尋找更多地點，而且選擇標準非常嚴格。我正在尋找那些能夠主動承擔起網站試用專案責任的領導者。篩選工作並不容易。選擇患者和招募患者並不容易，因此我們需要合適的地點、合適的研究人員和合適的團隊才能成功。

In terms of our projections, we are projecting that with the additional 8 sites we are going to be able to meet the goal of 339 by December of 2026. Now we are making a number of different moves in order to make this happen. We are extending into, for example, within the sites that we have. Into, other ICUs and so we're training other ICUs, for example, surgical ICUs, in order to, increase, the number of patients that we are able to screen in order to be able to capture more patients. And so, that's just one example, but there are several others, that, several other tweaks that we are making to increase our enrollment rate. Greater than what we have seen over the last few months, and so, based on, the historical enrollment rate, that we have seen with the addition of additional sites, we are confident that we can hit that number, that new number of 339 by December of 2026. Does that answer your question?

根據我們的預測，我們預計，加上新增的 8 個站點，我們將能夠在 2026 年 12 月之前實現 339 個站點的目標。現在我們正在採取一系列不同的措施來實現這一目標。例如，我們正在將業務拓展到我們現有的網站內部。我們正在培訓其他重症監護室，例如外科重症監護室，以便增加我們能夠篩檢的患者數量，從而能夠發現更多患者。所以，這只是一個例子，但還有其他幾個例子，我們正在進行其他一些調整來提高我們的入學率。比過去幾個月我們看到的要好得多，因此，根據歷史入學率，加上新增的站點，我們有信心在 2026 年 12 月之前達到 339 這個新數字。這樣回答了你的問題嗎？

Yeah, no, Kevin, that was great. That was the color I was looking for, so that, that's awesome. It sounds like. You, you've already identified, like you said, 8 more sites which would get you up to 25, but you'll move beyond that if all those criteria that you're looking for to be a site are met, and if you move beyond that 25, it, it'll give you further confidence that. You can get to the 339 by the end of December and maybe, if you're able to activate even more sites, maybe you achieve it before December of 26. Is that fair?

是的，凱文，那太棒了。這正是我想要的顏色，太棒了。聽起來像。正如你所說，你已經確定了另外 8 個網站，這使你的網站數量達到 25 個，但如果所有你尋找的網站標準都得到滿足，你就會超過這個數量。如果你超過 25 個，這將給你更大的信心。到 12 月底，你可以達到 339 個站點，如果你能夠啟動更多站點，也許你可以在 12 月 26 日之前達到這個目標。這樣公平嗎？

Yes, as I stated, we know what's at stake. We know time is of the essence, and, we want to get this study done and therefore, we're tracking this week by week, month to month, and, if we're not meeting the trajectory that we expect. Additional sites will be needed, and so right now, based on, my projections, based on the historical data of the number of patients we've enrolled to date per site per month, we are fairly confident that, the addition of 8 sites will get us there.

是的，正如我所說，我們知道利害關係有多大。我們知道時間至關重要，我們希望完成這項研究，因此，我們每週、每月都在追蹤這項研究，如果我們沒有達到我們預期的軌跡。我們需要更多的站點，因此，根據我的預測，根據我們迄今為止每個站點每月招募的患者數量的歷史數據，我們相當有信心，增加 8 個站點就能實現我們的目標。

Now if it looks like it won't, then we'll make additional adjustments. We're not going to be just sitting idle, hoping that we're going to hit 339. We are approved, as for up to 30 sites, so we'll be, moving in that direction if needed, but right now 25 sites is looking like, the number that we need to hit in order to reach our goal.

如果看起來不行，那麼我們將做出進一步調整。我們不會坐等達到 339 這個數字。我們已獲準設立最多 30 個站點，所以如果需要的話，我們將朝著這個方向努力，但目前看來，我們需要達到 25 個站點才能實現我們的目標。

Okay, that's great. And when, Eric mentioned about the new cardio renal trial, it's 20 patients, single arm, is that. Is that just literally beginning today and it's, or it's just been announced today, but that's very early stage and anymore, any more color on that. How long that'll take and. I know that's a new whole new category for you, so. Maybe just any color on that would be great. Thanks.

好的，太好了。艾瑞克提到新的心腎試驗時說，這是一項單組試驗，有 20 名患者，是這樣的。這件事是今天才正式啟動，還是今天才宣布的？目前還處於非常早期的階段，還沒有更多細節可以透露。這需要多長時間？我知道這對你來說是一個全新的領域，所以。或許任何顏色都行。謝謝。

Right, thank you, Anthony. We expect to enroll at, 5, at least 5 sites, for this trial. This is a very special population, who are not, these patients are not candidates for mechanical ventricular assist because of their AKI. And a variety of other reasons. And so we believe that we're going to be able to give these patients a chance to be able to bridge them to, be able to be candidates for mechanical, ventricular assist. In terms of timing, I, it, it's unclear how quickly we're going to be able to enrol. We're hoping to get enrol over the next year and finish in a year's time. But we won't know until we, really get into it and learn about the pace of screening and, the enrolment, over the number of patients screened, for example, at each site, all the institutions that we're working with for neutralized CRS are also neutralized AKI sites.

好的，謝謝你，安東尼。我們預計本次試驗將在至少 5 個地點招募受試者。這是一群非常特殊的人群，他們不適合接受機械心室輔助治療，因為他們患有急性腎損傷。以及其他各種原因。因此我們相信，我們將能夠為這些患者提供過渡機會，使他們能夠成為機械心室輔助裝置的候選人。就時間安排而言，目前還不清楚我們能多快報名。我們希望在未來一年內完成招生，並在一年內畢業。但只有真正深入了解並掌握篩檢速度和入組情況，例如每個地點篩檢的患者人數，我們才能知道結果。我們合作進行中和 CRS 的所有機構也是中和 AKI 的地點。

The patients don't compete, so we're looking for different patients for this particular trial. But we are projecting that, we should be done with, the enrolment of 20 patients, within a year. This is, subject to revision if, for example, site, activation is slowed. We have been screening for a couple of weeks and we've had a couple of, solid candidates, but they just were not enrolled. However, Once we activate the 5 sites, which, we'll be announcing one by one, we should be able to get there within the year, 5 sites, and that's not a lot of patients per site as you can tell.

患者之間沒有競爭關係，所以我們為這項特定的試驗尋找不同的患者。但我們預計，一年內應該可以完成 20 名患者的招募工作。如果例如網站啟動速度減慢，則此方案可能會進行修改。我們已經篩選了幾個星期，也找到了一些非常優秀的候選人，但他們最終都沒有被錄取。但是，一旦我們啟用這 5 個站點（我們會逐一宣布），我們應該能夠在一年內實現這個目標，5 個站點，正如你所看到的，每個站點的患者數量並不多。

Sure, no, that's helpful. And then the last question, for Eric, I thought I heard you mention on the call at the beginning of the call, obviously we know revenue at this stage can be a little bit, volatile, a little bit lumpy, but. Did you say, on target to do about a million or north of a million for the full year 25? Let me just clarify, thank you.

當然，這很有幫助。最後一個問題，是問艾瑞克的。我記得你在電話會議開始時提到過，顯然我們知道現階段的收入可能會有些波動，有些不穩定，但是…你是說，預計25年全年能達到一百萬美元或一百萬美元以上？讓我解釋一下，謝謝。

Yes, yeah. So thanks, Anthony. Yes, that's what we said is that we were on target to do, a million plus this year.

是的，沒錯。謝謝你，安東尼。是的，我們之前說過，我們今年預計將實現超過一百萬的目標。

Okay, great. All right, thanks so much. Appreciate it. I'll hop back to you too.

好的，太好了。好的，非常感謝。謝謝。我也會盡快回覆你。

Thank you. I'm showing no further questions at this time. I would like to turn it back to Jackie Kosman for closing remarks.

謝謝。我目前不再提出其他問題。我謹將發言權交還給傑基·科斯曼，請她作總結發言。

Thank you, Marvin, and thank you all for joining us today for the SeaSar Medical 3rd quarter Financial Results conference call. If you have questions, please contact us at ir@cstarmed.com or visit our website at www.Castarmedical.com. Thank you and goodbye.

謝謝馬文，也謝謝各位今天參加 SeaSar Medical 第三季財務業績電話會議。如有任何疑問，請聯絡我們：ir@cstarmed.com 或造訪我們的網站：www.Castarmedical.com。謝謝，再見。

Thank you for your participation in today's conference. Since that conclude the program, you may now disconnect.

感謝您參加今天的會議。程式到此結束，您現在可以斷開連線了。