SeaStar Medical Holding Corp (ICU) 2026 Q2 法說會逐字稿

Good day, and thank you for standing by. Welcome to the SeaStar Medical reports second quarter 2026 financial results. (Operator Instructions)

大家好，感謝您稍候等候。歡迎參加 SeaStar Medical 2026 年第二季財務業績報告。(接線員指示)

Please be advised that today's conference is being recorded. (Operator Instructions)

請注意，今天的電話會議將被錄音。(接線員指示)

I would now like to hand the conference over to your speaker today, Jackie Cossmon.

現在我想將會議交給今天的講者 Jackie Cossmon。

Thank you, Josh. Good afternoon, and thank you for joining the SeaStar Medical second quarter 2026 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; Tim Varacek, Senior Vice President of Commercial and Business Operations; Dr. Kevin Chung, Chief Medical Officer; and Mike Messinger, Chief Financial Officer.

謝謝你，Josh。各位下午好，感謝您加入 SeaStar Medical 2026 年第二季財務業績電話會議。我是 Wheelhouse Life Science Advisors 的 Jackie Cossmon。今天與我一同出席、來自 SeaStar Medical 的有：執行長 Eric Schlorff；商務與營運資深副總裁 Tim Varacek；醫務長 Kevin Chung 醫師；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 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，管理層在本次電話會議中的評論將包含符合聯邦證券法定義的前瞻性陳述。這些前瞻性陳述涉及風險與不確定性，可能導致實際結果與任何預期結果存在重大差異。

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, August 12, 2026. SeaStar Medical undertakes no obligation to revise or update any statements to reflect events or circumstances, except as required by law.

關於這些風險與不確定性的清單與說明，請查閱 SeaStar Medical 向美國證券交易委員會提交的文件。此外，本次電話會議內容所含資訊僅截至直播日期（2026 年 8 月 12 日）為準。除法律要求外，SeaStar Medical 不承擔修訂或更新任何陳述以反映事件或情況變化之義務。

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

現在我想把電話交給 Eric。Eric？

Thank you, Jackie, and thank you all for joining us today. We are very pleased with our progress this quarter. Our pediatric AKI market penetration and continued strong QUELIMMUNE revenue growth bodes well for our future potential opportunity in the adult AKI market that is 50 times larger than the pediatric market in the United States. Successful treatment of pediatric AKI with QUELIMMUNE therapy by patient care teams is driving greater clinical confidence from the tight knit critical care pediatric community, which we believe will only strengthen the future potential launch of this therapy in the adult AKI market.

謝謝你，Jackie，也感謝各位今天加入我們。我們對本季的進展感到非常滿意。我們在兒科 AKI 市場的滲透率，以及 QUELIMMUNE 營收持續強勁成長，對我們未來在成人 AKI 市場的潛在機會是很好的訊號；在美國，成人市場規模是兒科市場的 50 倍。病患照護團隊使用 QUELIMMUNE 治療成功處理兒科 AKI，正推動緊密的兒科重症照護社群對臨床的信心提升；我們相信，這將只會進一步強化該療法未來在成人 AKI 市場潛在上市的可能性。

Tim will speak further on our plans for our continued adoption of QUELIMMUNE in the pediatric AKI market and also discuss how we are strategically planning for a potential launch of this therapy in the adult AKI market.

Tim 將進一步說明我們在兒科 AKI 市場持續推動 QUELIMMUNE 採用的計畫，並討論我們如何為該療法在成人 AKI 市場的潛在上市進行策略性規劃。

And Kevin will describe our progress in our NEUTRALIZE-AKI pivotal clinical trial and our regulatory strategy for the adult AKI indication. Before I turn the call over to Tim, if you are new to SeaStar Medical story, I'd like to clarify that the same foundational therapy in QUELIMMUNE, known as the Selective Cytopheretic Device or SCD, is the same therapeutic device that we are evaluating in our pivotal study for the adult AKI indication.

Kevin 將說明我們在 NEUTRALIZE-AKI 關鍵性臨床試驗的進展，以及針對成人 AKI 適應症的法規策略。在我把電話交給 Tim 之前，如果您是第一次接觸 SeaStar Medical 的故事，我想先澄清：QUELIMMUNE 的同一項基礎療法（稱為選擇性細胞分離裝置，Selective Cytopheretic Device，或 SCD），也就是我們在成人 AKI 適應症關鍵性研究中正在評估的同一款治療裝置。

The adult version is simply a larger device to accommodate larger blood volumes. Also, I'd like to emphasize that our SCD therapy is first-in-class. It is the only immunomodulatory therapy that targets and neutralizes hyperactive leukocytes and monocytes and the immune cells primarily responsible for causing the cytokine storm that shuts down organs and takes the lives of far too many patients with AKI requiring renal replacement therapy.

成人版本只是為了容納更大的血液容量而設計的較大型裝置。此外，我也想強調，我們的 SCD 療法屬於同類首創（first-in-class）。它是唯一一種免疫調節療法，能夠鎖定並中和過度活化的白血球與單核球；這些免疫細胞是引發細胞激素風暴、導致器官衰竭並奪走太多需要腎臟替代治療之 AKI 病患生命的主要原因。

Given the unique mechanism of our SCD therapy and the significant value of finding a potential solution to this continued unmet need, I would note that we anticipate our current pharmacological or pharmaceutical like gross margins to continue for QUELIMMUNE and to extend to our adult therapies if approved. Furthermore, we believe that the FDA understands the importance of bringing innovative treatments advancements to critically ill patients with AKI.

鑑於我們 SCD 療法獨特的作用機制，以及為這項持續未被滿足的需求找到潛在解方所具備的重大價值，我要指出：我們預期 QUELIMMUNE 目前類似藥品的毛利率水準將可持續，且若成人療法獲准，也可延伸至成人療法。此外，我們相信 FDA 了解將創新治療進展帶給重症 AKI 病患的重要性。

The FDA approved QUELIMMUNE for pediatric AKI under humanitarian device exemption and also awarded us breakthrough device designation for the SCD therapy for adult patients with AKI on continuous renal replacement therapy, which should support a more collaborative and rapid approval process.

FDA 已在「人道醫療器材豁免」（humanitarian device exemption）下核准 QUELIMMUNE 用於兒科 AKI，並且也授予我們 SCD 療法「突破性醫療器材」資格，用於接受連續性腎臟替代治療（CRRT）的成人 AKI 病患，這應可支持更具協作性且更快速的核准流程。

We also have received breakthrough device designations for our other pipeline indications, including systemic inflammation from cardiac surgery and chronic inflammation in end-stage renal disease, among others. I provide this context today to reiterate our strong belief that our opportunity is significant.

我們也已針對其他研發管線適應症獲得突破性醫療器材資格，包括心臟手術引起的全身性發炎，以及末期腎臟病的慢性發炎等。我今天提供這些背景，是為了再次強調我們堅信自身機會相當可觀。

We remain keenly focused on achieving our near-term goals and understand the importance of driving new customer adoption for QUELIMMUNE and enrolling patients in our NEUTRALIZE-AKI trial. By the same token, we are not losing sight of our long-term opportunities and what SeaStar Medical can achieve for all our stakeholders.

我們仍然高度專注於達成短期目標，並了解推動 QUELIMMUNE 新客戶採用以及在 NEUTRALIZE-AKI 試驗中招募病患的重要性。同時，我們也不會忽視長期機會，以及 SeaStar Medical 能為所有利害關係人達成的成果。

With that, I'll turn it over to Tim. Tim?

接下來，我把電話交給 Tim。Tim？

Thanks, Eric, and thanks, everyone, for joining us today. We are making great progress in our efforts to establish QUELIMMUNE as an important therapy in the critical care of pediatric patients with AKI and sepsis. Currently, 20 of the 50 premier children's hospitals in the US have purchased and used our QUELIMMUNE therapy. Recall that our goal for 2026 is to increase the number of hospitals to 25 by the end of the year from 10 at the beginning.

謝謝你，Eric，也謝謝各位今天加入我們。我們在將 QUELIMMUNE 建立為兒科 AKI 與敗血症重症照護重要療法的努力上，正取得很大進展。目前，美國 50 家頂尖兒童醫院中已有 20 家購買並使用了我們的 QUELIMMUNE 療法。請記得，我們 2026 年的目標是將醫院數量從年初的 10 家提升至年底的 25 家。

So we have already doubled our customer base this year, and we are well on our way to achieving that goal. And as Eric indicated, the use of QUELIMMUNE therapy is broadly resonating in the pediatric critical care community.

因此，我們今年已將客戶基礎翻倍，且正穩步朝達成該目標邁進。正如 Eric 所指出，QUELIMMUNE 療法的使用在兒科重症照護社群中正廣泛引起共鳴。

Let me describe how. We discussed in our first quarter call the considerable interest in QUELIMMUNE at the AKI and CRRT meeting in San Diego. Adding to the buzz we observed there, we sponsored and participated in this year's KidneyBee Summit a few weeks ago.

我來說明一下。我們在第一季電話會議中提到，在聖地牙哥舉行的 AKI 與 CRRT 會議上，大家對 QUELIMMUNE 有相當高的興趣。在我們當時觀察到的熱度之外，我們也在幾週前贊助並參與了今年的 KidneyBee 高峰會。

The summit occurs annually and brings together a highly specialized interdisciplinary team, including nurses, advanced practice providers, nephrologists, and critical care physicians from across the country. Its core importance stems from tackling the exact systemic failures that leave pediatric kidney failure under-recognized.

該高峰會每年舉行一次，匯聚高度專業的跨領域團隊，包括護理師、進階實務提供者（advanced practice providers）、腎臟科醫師與重症醫師，來自全國各地。其核心重要性在於處理那些使兒科腎衰竭未被充分辨識的確切系統性失靈問題。

And just yesterday, we assembled leading experts in the treatment of pediatric AKI to speak at a SeaStar Medical educational webinar. The webinar was entitled Rethinking Pediatric Sepsis-Associated AKI, what Clinicians should know about QUELIMMUNE. We brought together practicing pediatric nephrologists, critical care physicians, advanced practice providers, and nurses to learn more about pediatric sepsis-associated AKI, the use of QUELIMMUNE therapy through case reviews and how to navigate QUELIMMUNE adoption within hospitals.

而就在昨天，我們邀集了兒科 AKI 治療領域的領先專家，在 SeaStar Medical 的教育網路研討會上進行分享。該研討會題為「重新思考兒科敗血症相關 AKI：臨床醫師應了解的 QUELIMMUNE」。我們匯聚了執業中的兒科腎臟科醫師、重症醫師、進階實務提供者與護理師，透過病例回顧進一步了解兒科敗血症相關 AKI、QUELIMMUNE 療法的使用方式，以及如何在醫院內推動 QUELIMMUNE 的採用。

Both events were very well attended and provided an opportunity for the pediatric community to get answers to key operational questions, gain exposure to the rich content from cutting-edge scientific and clinical data in sepsis-associated pediatric AKI and how to apply that knowledge to employ our QUELIMMUNE therapy at the hospitals in which they practice. As previously stated, this is an ultra-rare population with a very high unmet need and as the first and only therapy available to treat children with AKI and sepsis, QUELIMMUNE is helping to drive new thinking in the pediatric AKI community.

這兩場活動都出席踴躍，並為兒科社群提供機會，針對關鍵營運問題獲得解答，接觸敗血症相關兒科 AKI 的前沿科學與臨床資料所帶來的豐富內容，並了解如何運用這些知識，在其執業的醫院中導入我們的 QUELIMMUNE 療法。如先前所述，這是一個極為罕見的族群，且未被滿足的需求非常高；作為第一個也是唯一可用於治療 AKI 與敗血症兒童的療法，QUELIMMUNE 正在協助推動兒科 AKI 社群的新思維。

Now turning to our revenue targets and future opportunities in this ultra-rare pediatric market. We reported QUELIMMUNE net revenues of $615,000 in the second quarter, a strong 82% increase over last year's second quarter. And with six-month net revenue at $1.1 million, momentum remains strong as we advance toward our 2026 net revenue target of $2 million.

現在轉向我們在這個超罕見兒科市場的營收目標與未來機會。我們在第二季報告 QUELIMMUNE 淨營收為 61.5 萬美元，較去年第二季大幅成長 82%。而上半年淨營收達 110 萬美元，隨著我們朝 2026 年 200 萬美元的淨營收目標邁進，動能仍然強勁。

In short, we are very encouraged by the current rate of QUELIMMUNE adoption, and we continue to focus on adding new customers as quickly as possible. We have great expectations of helping more patients by bringing our QUELIMMUNE therapy to more pediatric hospitals. And as we look to 2027 and beyond, we believe we can expand our overall market opportunity beyond the top 50 pediatric medical centers.

簡而言之，我們對 QUELIMMUNE 目前的採用速度深受鼓舞，並持續專注於以最快速度新增客戶。我們非常期待能透過將 QUELIMMUNE 治療帶進更多兒科醫院，幫助更多病患。展望 2027 年及之後，我們相信可將整體市場機會擴大至前 50 大兒科醫學中心之外。

We announced in June that the Centers for Medicare and Medicaid Services, also known as CMS, assigned ICD-10-PCS codes for our SCD therapy, allowing hospitals to efficiently bill for QUELIMMUNE therapy when used in treating sepsis-associated pediatric AKI. And we believe all future potential indications from our SCD therapy will use the same PCS code.

我們於 6 月宣布，美國醫療保險與醫療補助服務中心（Centers for Medicare and Medicaid Services，亦稱 CMS）已為我們的 SCD 治療指派 ICD-10-PCS 代碼，使醫院在以 QUELIMMUNE 治療用於敗血症相關兒科 AKI 時，能夠有效率地進行申報與請款。我們也相信，未來所有來自我們 SCD 治療的潛在適應症都將使用相同的 PCS 代碼。

The implementation of the new ICD-10 PCS code initiates on October 1 of this year. This is an important administrative development as it removes another potential barrier to QUELIMMUNE adoption. In addition, we have completed the 50-patient SAVE registry that was required by the FDA to further evaluate the safety of our QUELIMMUNE therapy.

新的 ICD-10 PCS 代碼將於今年 10 月 1 日開始實施。這是一項重要的行政進展，因為它移除了 QUELIMMUNE 採用的另一個潛在障礙。此外，我們已完成 FDA 要求的 50 名病患 SAVE 登錄研究，以進一步評估 QUELIMMUNE 治療的安全性。

Our preliminary report was submitted, and we are now preparing the final report for FDA review. Our results from the first 21 patients were reported in the prestigious peer-reviewed journal, Pediatric Nephrology, and that alone has driven continued interest in adopting QUELIMMUNE.

我們已提交初步報告，目前正準備最終報告供 FDA 審查。我們前 21 名病患的結果已發表於享有盛名的同儕審查期刊《Pediatric Nephrology》，而僅此一項就已帶動對採用 QUELIMMUNE 的持續興趣。

So in summary, the future for our QUELIMMUNE therapy looks bright as we continue to expand into the pediatric market and work in parallel on pre-commercialization efforts focused on the adult AKI population, which is estimated to be 50 times larger than the sepsis-associated pediatric AKI population in the US Thank you for your attention.

總結而言，隨著我們持續拓展兒科市場，並同步推進以成人 AKI 族群為重點的上市前準備工作，QUELIMMUNE 治療的未來前景看好；據估計，在美國成人 AKI 族群規模約為敗血症相關兒科 AKI 族群的 50 倍。感謝各位的關注。

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

接下來，我將把簡報交給我們的首席醫療長 Kevin Chung。Kevin？

Thanks, Tim, and thank you to everyone for listening to our call. I want to echo Tim's enthusiasm about our growing presence in the pediatric critical care community. It is rewarding to hear how these nephrology and critical care teams are adopting the QUELIMMUNE therapy and understanding that it is truly the first of its kind. These kids have days, if not hours, to live, and we have heard many stories about first-time use of QUELIMMUNE with life-saving outcomes. These stories are truly remarkable, and they continue to validate and reinforce why getting this therapy to a broader patient population is so important.

謝謝你，Tim，也感謝各位收聽我們的電話會議。我想呼應 Tim 對我們在兒科重症照護社群中日益提升的能見度所抱持的熱忱。聽到這些腎臟科與重症照護團隊正在採用 QUELIMMUNE 治療，並理解它確實是同類首創，令人感到欣慰。這些孩子的生命只剩下幾天，甚至幾小時，而我們聽到許多關於首次使用 QUELIMMUNE 即帶來挽救生命結果的故事。這些故事確實令人驚嘆，也持續驗證並強化了為何將此治療帶給更廣泛病患族群如此重要。

And to be clear, we believe that QUELIMMUNE for pediatric AKI indication is just the first of a broad range of indications for our SCD therapy. To our knowledge, no other pharmaceutical therapy or medical device on the market today is able to identify, target and neutralize the specific immune cells that cause hyper-inflammation. That means the SCD's unique immunomodulatory mechanism positions us to potentially reshape treatment paradigms across a range of serious inflammatory conditions, not only for AKI, but cardiorenal syndrome, systemic inflammation from cardiac surgery, chronic inflammation in end-stage renal disease and other states of pathologic immune activation where dysregulated cytokine release drives organ failure and death, which brings me to the discussion highlighting our efforts to bring our SCD therapy to critically ill adult patients with AKI requiring CRRT.

需要說明的是，我們認為 QUELIMMUNE 的兒科 AKI 適應症只是我們 SCD 治療廣泛適應症版圖中的第一個。據我們所知，目前市面上沒有任何其他藥物治療或醫療器材能夠辨識、鎖定並中和導致過度發炎的特定免疫細胞。這意味著 SCD 獨特的免疫調節機制，使我們有機會在一系列嚴重發炎性疾病中重塑治療典範，不僅是 AKI，還包括心腎症候群、心臟手術引起的全身性發炎、末期腎病的慢性發炎，以及其他病理性免疫活化狀態；在這些狀態中，失調的細胞激素釋放會驅動器官衰竭與死亡。這也引出接下來的討論：我們致力於將 SCD 治療帶給需要 CRRT 的重症成人 AKI 病患。

We are currently conducting the NEUTRALIZE-AKI trial and have plans to file a modular premarket approval or PMA with the FDA to potentially speed the overall approval process for this important indication. The modular PMA enables the FDA to review and potentially comment on portions of our application prior to submitting all modules, the last of which would be the submission of the NEUTRALIZE-AKI clinical trial results.

我們目前正在進行 NEUTRALIZE-AKI 試驗，並計畫向 FDA 提交模組化上市前核准（premarket approval，PMA），以期加速此重要適應症的整體核准流程。模組化 PMA 讓 FDA 能在我們提交所有模組之前，先行審查並可能對申請文件的部分內容提出意見；最後一個模組將是提交 NEUTRALIZE-AKI 臨床試驗結果。

I would also note that we have been awarded breakthrough device designation for this indication, which should support expedited regulatory review. As a reminder, our NEUTRALIZE-AKI pivotal trial is a randomized controlled trial designed to assess the SCD therapy in critically ill adult patients with AKI requiring CRRT. The primary endpoint is a composite of mortality or dialysis dependence at 90 days.

我也要指出，我們已就此適應症獲得突破性醫療器材認定（breakthrough device designation），這應可支持加速的法規審查。提醒各位，我們的 NEUTRALIZE-AKI 關鍵性試驗是一項隨機對照試驗，旨在評估 SCD 治療在需要 CRRT 的重症成人 AKI 病患中的效果。主要終點為 90 天時的複合指標：死亡或透析依賴。

We now have enrolled 223 of our total anticipated 339 patients in the trial and have stepped up our site recruitment to accelerate the pace of enrollment as we move forward. We recently onboarded two additional clinical sites who have already recruited patients.

目前我們已在試驗中納入 223 名病患，總預計納入 339 名；隨著計畫推進，我們已加強站點招募，以加速入組進度。我們最近新增兩個臨床站點，且已開始招募病患。

We have 4 additional sites that we anticipate will be screening patients shortly and at least 8 more sites that have committed to participating in the trial. Our sites are extremely motivated and are continuously screening patients. When they identify potentially eligible patients, our sites are typically able to successfully consent and enroll those patients into our trial. This reflects highly on the site investigators and incredibly professional research staff who are tactfully approaching family members during a patient's most desperate hour in the ICU. We must emphasize that we continue to be focused on enrolling the right type of patients.

我們另有 4 個站點預期將很快開始篩選病患，並且至少還有 8 個站點已承諾參與此試驗。我們的站點動力十足，並持續不斷地篩選病患。當他們辨識出可能符合條件的病患時，通常能成功取得同意並將病患納入試驗。這充分反映站點研究者與極其專業的研究團隊表現出色，他們在 ICU 中病患最危急的時刻，仍能以得體方式與家屬溝通。我們必須強調，我們仍然專注於納入正確類型的病患。

This careful selection of patients is essential to demonstrating therapeutic effect and avoiding the limitations that have confounded prior AKI and sepsis trials. One of our enrichment criteria is a C-reactive protein or CRP level greater than 3.5 milligrams per deciliter. Patients who do not have a CRP greater than 3.5 are excluded. Why? CRP is a very sensitive marker of inflammation and those patients with a low CRP are unlikely to benefit from our therapeutic device.

這種謹慎的病患選擇對於證明治療效果至關重要，也能避免過去 AKI 與敗血症試驗中造成混淆的限制因素。我們的一項富集（enrichment）條件是 C 反應蛋白（C-reactive protein，CRP）大於每分升 3.5 毫克。CRP 未達 3.5 的病患將被排除。為什麼？CRP 是非常敏感的發炎指標，而 CRP 偏低的病患不太可能從我們的治療器材中獲益。

In past interventional sepsis or AKI trials directed at inflammation, many of these types of patients were included and those trials ultimately failed. Beyond CRP, we are also applying our carefully considered exclusion criteria to remove patients whose pre-existing conditions could obscure the true treatment effect, patients who might not survive regardless of whether the SCD works. This is the same disciplined approach we took in our pediatric trials, and it is the right way to design a study that can demonstrate therapeutic benefit.

在過去針對發炎的介入性敗血症或 AKI 試驗中，常納入許多這類病患，而那些試驗最終都以失敗告終。除了 CRP 之外，我們也採用經審慎考量的排除條件，以排除其既有疾病可能掩蓋真實治療效果的病患，以及無論 SCD 是否有效都可能無法存活的病患。這與我們在兒科試驗中採取的嚴謹方法一致，也是設計能夠證明治療效益之研究的正確方式。

It is worth emphasizing that clinical trial populations are by design more narrowly defined than real-world practice. We are seeing in the commercial setting, physicians who are already applying QUELIMMUNE to a much broader on-label population of pediatric patients than those enrolled in our trials, including patients with complex comorbidities who would not have met trial eligibility criteria.

值得強調的是，臨床試驗族群在設計上會比真實世界臨床實務更為狹窄。我們在商業化實務中看到，醫師已將 QUELIMMUNE 應用於更廣泛、符合標籤（on-label）的兒科病患族群，範圍甚至超過我們試驗中納入的病患；其中包括具有複雜共病、原本不符合試驗納入標準的病患。

That broader real-world use reflects clinical confidence in the therapy and suggests the addressable patient population is larger than what our trial enrollment numbers alone might imply. We are making meaningful progress in NEUTRALIZE-AKI and our confidence in the trial design and site execution has never been higher.

這種更廣泛的真實世界使用反映了臨床對該治療的信心，也顯示可觸及的病患族群可能比僅從我們的試驗入組數字所推估的更大。我們在 NEUTRALIZE-AKI 方面正取得實質進展，而我們對試驗設計與站點執行的信心從未如此高。

As we discussed, enrolling the right patients takes precedence over enrolling quickly and our sites are delivering on that standard. While we expect to complete enrollment around year-end or in the first quarter of 2027, our PMA submission timeline in late 2027 remains unchanged. The breakthrough device designation we hold for this indication means that when we submit, the FDA is positioned to move quickly.

如同我們先前討論的，招募到合適的病患比快速招募更為優先，而我們的各研究中心也確實達到這項標準。雖然我們預期將在年底左右或 2027 年第一季完成收案，但我們在 2027 年下半年提交 PMA 的時程仍維持不變。我們針對此適應症所持有的突破性醫療器材認定，意味著當我們提交時，FDA 將能夠快速推進審查。

A PMA approval of the SCD therapy for adult patients with AKI on CRRT would enable commercialization with ICD-10 PCS codes in place, significantly simplifying hospital adoption. Also, given the foundation we are establishing in the pediatric critical care community with QUELIMMUNE, we believe it would support more rapid adoption among nephrology and critical care experts in the adult AKI community. We are passionate about our ability to improve and potentially save lives of these critically ill patients and look forward to reporting our progress.

若 SCD 治療用於接受 CRRT 的成人 AKI 病患取得 PMA 核准，將可在既有 ICD-10 PCS 代碼到位的情況下進行商業化，並大幅簡化醫院端的導入。此外，鑑於我們透過 QUELIMMUNE 在小兒重症照護社群中建立的基礎，我們相信這將支持成人 AKI 社群中的腎臟科與重症照護專家更快速採用。我們對於改善、甚至可能挽救這些重症病患生命的能力充滿熱忱，並期待向各位報告我們的進展。

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

接下來，我把時間交給我們的財務長 Mike Messinger。Mike？

Thank you, Kevin, and thanks, everyone, for joining our call today. I'll provide a brief overview of our financial results for the second quarter of 2026. Please note that our Form 10-Q will be filed with the SEC within the next 24 hours, and it will include a lengthier discussion of the company's financial results for the three months ended June 30, 2026. You will find the 10-Q at sec.gov or through our website at seastarmedical.com.

謝謝你，Kevin，也謝謝各位今天加入我們的電話會議。我將簡要概述我們 2026 年第二季的財務結果。請注意，我們的 Form 10-Q 將在未來 24 小時內向 SEC 提交，其中將更詳細討論截至 2026 年 6 月 30 日止三個月的公司財務結果。您可在 sec.gov 或透過我們的網站 seastarmedical.com 查閱 10-Q。

We recorded net revenue for the second quarter of $615,000, reflecting increased demand for QUELIMMUNE. This represents an 82% increase compared to net revenue of approximately $338,000 for the second quarter of 2025 and this is an increase in the rate of growth from the 69% growth we had in the first quarter. And we continue to maintain our gross profit percentage of over 90% in the second quarter of 2026, consistent with the prior four quarters.

我們在第二季認列淨營收 61.5 萬美元，反映 QUELIMMUNE 需求增加。相較於 2025 年第二季約 33.8 萬美元的淨營收，成長 82%，且相較第一季 69% 的成長，成長率有所提升。我們在 2026 年第二季的毛利率仍維持在 90% 以上，與前四個季度一致。

Turning now to our operating expenses. In the second quarter of 2026, we reported $4.4 million in operating expenses compared to $2.1 million in the second quarter of 2025. Our research and development expenses increased primarily to the additional clinical sites and increased patient enrollment compared to the same period in 2025.

接著談營業費用。2026 年第二季，我們的營業費用為 440 萬美元，較 2025 年第二季的 210 萬美元增加。研發費用增加主要是因為新增臨床試驗中心，以及相較 2025 年同期病患收案增加。

And our general and administrative expenses increased compared to the second quarter of 2025, primarily to an increase in compensation costs, legal and professional fees, and certain SEC-related expenses. As we indicated in our first quarter call, we expected our sequential quarterly research and development costs to increase based on adding additional clinical sites and our focused recruitment efforts. We did see a roughly mid-single-digit increase over our first quarter, and we continue to expect the same for the rest of 2026 as we anticipate meeting our enrollment goals.

我們的一般及行政費用亦較 2025 年第二季增加，主要原因為薪酬成本上升、法律與專業服務費用增加，以及部分與 SEC 相關的費用。如同我們在第一季電話會議中所提到，隨著新增臨床試驗中心以及我們聚焦的招募工作，我們預期研發費用將呈現逐季增加。我們確實看到相較第一季約中個位數百分比的增幅，並且在 2026 年剩餘期間，隨著我們預期達成收案目標，仍預期維持相同趨勢。

Net loss for the second quarter of 2026 was approximately $3.7 million or $0.91 per share based on weighted average shares outstanding of approximately 4.1 million shares. This compares with a net loss of approximately $2 million or $1.77 per share in the second quarter of 2025 based on approximately 1.1 million weighted average shares outstanding. We had approximately $7 million of cash on our balance sheet at June 30, 2026, compared to $12 million at December 31, 2025.

2026 年第二季淨損約 370 萬美元，或每股 0.91 美元，係以約 410 萬股加權平均流通在外股數計算。相較之下，2025 年第二季淨損約 200 萬美元，或每股 1.77 美元，係以約 110 萬股加權平均流通在外股數計算。截至 2026 年 6 月 30 日，我們資產負債表上的現金約 700 萬美元，較 2025 年 12 月 31 日的 1,200 萬美元減少。

And with that, I'll turn it back to Eric.

接下來，我把時間交回給 Eric。

Thanks, Mike. Our goal today was to share with you our second quarter achievements, but also express how keenly focused we are on the key value drivers, both short and long term for our stakeholders. We have a small but passionate team at SeaStar Medical, yet we believe we are reshaping the possibility for kids and in the future, potentially adults that often face organ failure or death without new therapies to modulate the cytokine storm in acute kidney injury.

謝謝你，Mike。我們今天的目標是與各位分享第二季的成果，同時也表達我們對於關鍵價值驅動因素的高度聚焦，這些因素對我們的利害關係人而言，無論短期或長期都很重要。SeaStar Medical 擁有一支規模不大但充滿熱忱的團隊；然而，我們相信我們正在重塑可能性，為那些兒童，以及未來可能的成人病患帶來希望——在急性腎損傷中，若沒有新的療法來調節細胞激素風暴，他們往往面臨器官衰竭或死亡。

Our goal is to set a higher standard for the treatment of all patients that face the trauma of AKI. We believe that the opportunities that lie ahead for SeaStar Medical are significant, and we look forward to reporting our future progress.

我們的目標是為所有面臨 AKI 創傷的病患建立更高的治療標準。我們相信 SeaStar Medical 未來的機會相當可觀，並期待向各位報告後續進展。

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

接下來，我請接線員開放提問。接線員？

(Operator Instructions) David Bautz, Zacks Small-Cap Research.

(接線員指示) David Bautz，Zacks Small-Cap Research。

First one, I was wondering if you could comment on what the current monthly enrollment rate is for the NEUTRALIZE-AKI study? And if you're seeing any type of acceleration of enrollment at the newer high-volume sites? And then lastly, can you quantify your confidence for hitting that 339 patients either by year-end or the first quarter of '27?

第一個問題，我想請你們評論一下 NEUTRALIZE-AKI 研究目前每月的收案速度是多少？以及在較新的高量能研究中心，你們是否看到任何收案加速的情況？最後，你們能否量化一下你們對於在年底或 27 年第一季達到 339 名病患收案目標的信心程度？

Yes. So thanks for the question. So let me tackle the second one. What we've basically kind of guided the market is really our timeline is around year-end or into Q1. Obviously, it's going to depend on Kevin and his team bringing on additional sites, et cetera, from an enrollment standpoint.

好的。謝謝你的問題。我先回答第二個。我們基本上對市場所提供的指引是，我們的時程大約在年底或延伸到第一季。當然，這將取決於 Kevin 和他的團隊在收案面向上導入更多研究中心等因素。

But I'm really proud of what Kevin and his team are doing on bringing those kind of on pace. But if I think about this, David, before he kind of talks about maybe enrollment, we still believe that we're really on track at the end of the day to have end of 2027 submission for the final PMA module, which obviously really not impacting the timeline. But maybe, Kevin, you could talk a little bit about enrollment of various sites.

但我對 Kevin 和他的團隊讓這些工作按進度推進感到非常自豪。不過 David，如果我從整體來看，在他談到收案之前，我們仍相信最終我們在 2027 年底提交最終 PMA 模組的進度確實在軌道上，這顯然不會影響整體時程。但 Kevin，也許你可以談談各研究中心的收案情況。

Right. Thank you, Eric. So on average, over the last few months, we've averaged somewhere around 8 to 10 to 12 patients in each of those months. And that's relatively slower than what I would like. However, I have to emphasize, we have to get the right patients.

好的。謝謝你，Eric。就平均而言，在過去幾個月，我們每個月大約收案 8 到 10 到 12 位病患。這相對比我希望的速度更慢。不過，我必須強調，我們必須納入合適的病患。

And by right patients, I mean those with modifiable disease. What's the point in getting finished with enrollment if we enroll a bunch of patients out of haste to try to just get our number, and we're not enrolling the right patients. That would be a flawed strategy. For me, the focus is on getting the right patients enrolled so that we optimize our chance for success. That's number one.

所謂合適的病患，我指的是疾病具有可調整性的病患。如果我們只是因為急著要達到人數而匆忙收案，納入一堆病患，但並非合適的病患，那麼即使完成收案又有什麼意義？那會是一個有缺陷的策略。對我而言，重點是納入合適的病患，以便最大化我們成功的機會。這是第一點。

Number two, as we discussed in the report in our update, we're very busy right now activating in the process of activating numerous sites. As I said, there are four that are so close to getting activated, just some residual signatures and et cetera, those kinds of things, and we're ready to activate them. And so we're going to be very soon be seeing some reinforcements come in with an additional four sites ready to go, already trained. SIVs have already performed, site initiation visits. So we're ready to go with those sites.

第二點，如同我們在報告更新中所討論的，我們目前正忙於啟動、並處於啟動多個研究中心的流程中。如我所說，有四個中心已非常接近完成啟動，只剩一些簽署等收尾事項，我們就能啟動。因此，我們很快就會看到增援到位，另外四個研究中心已準備就緒、也已完成訓練。SIVs 已經完成，也就是研究中心啟動訪視（site initiation visits）。所以這些研究中心已準備好開始運作。

There are additional eight sites, half of whom contacted us because they wanted in on the trial. And so they've committed. Now whether or not we're going to be able to activate all eight sites is still debatable. But we're going to try to get as many sites activated as possible because that's going to get us to 15 to 20 subjects per month, which is more at the pace that I would like. Again, though, focused on the right patients.

另外還有八個站點，其中一半是因為想參與試驗而主動聯繫我們。因此他們已經承諾加入。至於我們是否能夠啟動全部八個站點，仍有待商榷。但我們會盡可能啟動更多站點，因為那將使我們每月能招募到15到20名受試者，這更符合我希望的節奏。不過再次強調，重點仍是鎖定正確的病患。

We have to get the right patients. We have to get that right to have a chance for a positive trial.

我們必須找到合適的病患。我們必須把這件事做對，才有機會讓試驗得到正向結果。

Okay. Great. So with the enrollment expected by the end of this year, early 2027 and the PMA submission target for the end of 2027, I was wondering if you could just walk through what are the major activities for the PMA that need to happen, say, after enrollment or after database lock before you can fully submit it?

好的。很好。那麼，若預計在今年底、2027年初完成入組，且PMA申請目標是在2027年底提交，我想請你說明一下，PMA需要完成的主要工作有哪些？例如在入組完成後或資料庫鎖定（database lock）後，到能夠完整提交之前，主要活動是什麼？

Yes. So your question is what are some of the -- well, once we lock the database, obviously, then we'll give out top line results. Once it's locked, we can analyze, et cetera. And then really, it's just submitting the clinical section is really essentially because all the other previous sections will have been submitted by that time. And that's really what the goal is so that when the FDA then has their time, they can then focus just merely on the clinical sections and not have to go through things like device and description, et cetera.

是的。所以你的問題是一些——嗯，一旦我們鎖定資料庫，顯然我們就會公布初步（top line）結果。鎖定後我們就可以進行分析等等。接下來其實主要就是提交臨床部分，因為到那個時候其他先前的各個部分都已經提交了。這正是我們的目標：讓FDA在審查時能把重點放在臨床部分，而不必再去審查例如器械與描述等內容。

So that's really what the strategy is.

這就是我們的策略。

Okay. Sounds good. And then last one, talking about the increase in revenue. I was wondering if you could quantify the contribution from existing customers versus the new hospitals that you added during the quarter?

好的。聽起來不錯。最後一個問題，關於營收的增加。我想請問你能否量化一下，本季營收成長中，既有客戶與本季新增醫院各自的貢獻？

Yes. Tim, do you want to tackle that one?

可以。Tim，你要不要回答這題？

Sure. Yes. So it's a combination of new hospital systems as well as existing hospital systems that delivered that revenue. And we have a very high repurchase rate with the existing sites. And then obviously, the new sites that come on board, they want to stock the product as soon as they can so that they're ready to treat patients. So it was a group effort by all of the customers that were out there.

當然。是的。這是新加入的醫院體系以及既有醫院體系共同帶來的營收。我們在既有站點的再購率非常高。而新站點一加入，顯然也會希望盡快備貨，以便隨時準備治療病患。所以這是所有客戶共同努力的成果。

Anthony Vendetti, Maxim Group.

Anthony Vendetti，Maxim Group。

Can you talk about the milestones between completing enrollment and then the final PMA submission? I think you mentioned you submitted the preliminary, right?

你能談談在完成入組到最終提交PMA之間的里程碑嗎？我記得你提到你們已經提交了初步的（資料），對嗎？

No, we're submitting preliminary report. Yes. So we're submitting well, so you're talking about the PMA, right, for adults?

不，我們要提交的是初步報告。是的。所以我們正在提交——嗯，你是在問PMA對吧，成人的那個？

Yes. Yes, yes, yes.

是的。對，對，對。

Yes. So yes, for that, I mean, obviously, what we're doing right now is a modular PMA. So there's various sections where you talk about the device, you talk about sterilization, you talk about all sorts of kind of the technical things that go into it. But then you get into that -- what the goal really is, Anthony, is to have those sections already submitted to the FDA, already have had the discussions with the FDA on those sections. And so really, what you're waiting for at the end is once you have data lock and then you can show top line and do the analysis, then you're really just submitting the clinical section of it.

是的。所以就那個而言，我的意思是，顯然我們現在做的是模組化PMA（modular PMA）。因此有各個不同的部分，例如器械、滅菌，以及各種相關的技術內容。但接下來——真正的目標，Anthony，是讓這些部分都已經提交給FDA，並且已經就這些部分與FDA完成討論。因此最後你真正等待的是：一旦資料鎖定，然後你能展示初步結果並完成分析，接著你基本上就只需要提交其中的臨床部分。

Okay. And so you've submitted already the certain sections and --

好的。所以你們已經提交了某些部分，然後--

No, we're in the process. Yes, we're in the process of doing that.

沒有，我們正在進行中。是的，我們正在進行這件事。

Yes. Got it. Okay. And then you have right now about 20 pediatric hospitals, right?

是的。了解。好的。那你們目前大約有20家兒科醫院，對吧？

Correct.

沒錯。

So is there a process? Or what do you have to do to make sure they're not just sort of like, okay, there a hospital that uses this, but how do you get them to be a more meaningful recurring customers? Or just, hey, you just need the patients to come in and they're already on board and there's nothing really left to do with those particular hospitals?

那有沒有一個流程？或者你們需要做什麼，才能確保他們不只是「好吧，這是一家會用這個的醫院」，而是如何讓他們成為更有意義的經常性客戶？還是說，你們只需要病患進來，他們就已經準備好了，對這些特定醫院其實沒有太多後續要做的？

Yes. Maybe, Tim, you could kind of address it. And then Kevin if you would like to add any additional comments on top of it. It is really a multidisciplinary approach that we take to these hospital systems.

是的。Tim，也許你可以先回應一下。然後Kevin，如果你想補充，也歡迎再加一些評論。我們對這些醫院體系採取的確實是一種多學科（multidisciplinary）的方式。

Okay.

好的。

Yes, it absolutely is. Just to give you insight. So let's say, a hospital just came into the fold today. They've adopted QUELIMMUNE formally. There was a whole process that took place in terms of IRB approval, becoming a qualified vendor, all the associated things you have to do to basically be a customer to the hospital system.

是的，確實如此。我稍微提供一些背景。假設某家醫院今天剛加入我們。他們已正式採用QUELIMMUNE。在此之前有一整套流程，包括IRB核准、成為合格供應商，以及所有相關事項——基本上要成為該醫院體系的客戶所必須完成的事情。

Then a patient actually shows up in the emergency room, gets moved to the ICU and QUELIMMUNE becomes something that's top of mind. We have then the clinical team that will come over. They'll actually help the setup of that first patient to ensure everything goes smoothly. Now in terms of what happens after that, there's a lot of work to do because these -- every hospital system is large. They have a lot of different staff.

接著，當病患真的出現在急診室，被轉入加護病房（ICU），QUELIMMUNE就會成為優先考量之一。然後我們的臨床團隊會到場。他們會實際協助第一位病患的裝置設定，確保一切順利。至於之後會發生什麼，還有很多工作要做，因為——每個醫院體系都很大。他們有很多不同的工作人員。

They have different shifts. And so there really needs to be an educational approach to that hospital system that never ends because there's turnover like in any other business. And our goal is to continually increase not just the breadth, but the depth that we get to within all of our customer base and the new ones that we'll add so that QUELIMMUNE is something that's top of mind for the patient care teams because we believe that while QUELIMMUNE is a super effective therapy, if you don't know about it and a patient comes in and there's not one of your advocates there, they may not realize that they could use QUELIMMUNE to treat that patient.

他們有不同的輪班。因此，對該醫院體系需要一種持續不斷的教育方式，因為就像任何其他企業一樣會有人員流動。我們的目標是持續提升——不只是覆蓋的廣度，也包括在所有既有客戶與未來新增客戶中的滲透深度——讓QUELIMMUNE成為照護團隊優先想到的選項。因為我們相信，雖然QUELIMMUNE是一種非常有效的治療方式，但如果你不知道它，而病患進來時又沒有你們的倡議者在場，他們可能不會意識到可以用QUELIMMUNE來治療該病患。

So it's a continual effort from a commercial standpoint and from a clinical standpoint to ensure that we really ingrain the brand into these hospital systems, and they understand the clinical value of it so that they recognize patients when they come in and they can choose to use QUELIMMUNE therapy as an option when it's there and it's available.

因此，從商業端與臨床端來看，這都是一項持續性的努力，以確保我們能真正把品牌深植於這些醫院體系之中，並讓他們理解其臨床價值；如此一來，當病患進來時，他們能辨識出適用的病患，並在有且可用的情況下，選擇將QUELIMMUNE療法作為一個治療選項。

Okay. So just to understand, so obviously, getting into the hospital is just the first step and trying to make sure all the trained health care professionals that could use it, a, know the benefit, know how to use it and you stay engaged because like you said, if there's new doctors, nurses or so forth that are coming in, you want to make sure that they are aware of the treatment of the application of the QUELIMMUNE, correct?

好的。所以只是為了確認我的理解，顯然，進入醫院只是第一步；接著要確保所有可能會使用它、受過訓練的醫療專業人員都能夠：a，了解其效益、知道如何使用，並且你們要持續投入，因為如你所說，如果有新的醫師、護理師等等加入，你們會希望確保他們了解 QUELIMMUNE 的治療與其應用，對嗎？

100%.

百分之百。

If I may add some color to the clinical perspective. So yesterday, we conducted a webinar that will make available very soon so that those of you who missed the webinar or had technical difficulties are able to dial in. During that discussion, it became -- it was -- this has been clear, but it became more clear to me that there's a big difference between new sites that have device and mature sites that have device.

如果我可以從臨床角度補充一些說明。昨天，我們舉辦了一場網路研討會，很快就會提供回放，讓錯過研討會或遇到技術問題的各位也能夠撥入收聽。在那場討論中，我們變得——它一直很清楚，但對我而言更清楚的是：擁有裝置的新站點與擁有裝置的成熟站點之間存在很大的差異。

New sites any time there's a new technology, even if it's lifesaving, because of the natural skepticism that is very prevalent within the medical community, they have to see it work. And so generally, it's used as a rescue therapy.

新站點在任何新技術出現時，即便它能救命，由於醫療界普遍存在的自然懷疑態度，他們必須先看到它有效。因此，一般會把它當作救援治療來使用。

And what I mean by that is it's used for the new sites as a last resort, oftentimes with a bunch of other experimental therapies that are not even approved being applied prior to SCD. So that's new sites. That's the approach that they take. And that's been true for almost every site that have been activated because whenever a therapy is new, that's what's going to happen.

我的意思是，對新站點而言，它會被當作最後手段使用，往往在 SCD 之前已先使用了一堆其他實驗性療法，其中有些甚至尚未獲准。這就是新站點。這就是他們採取的方法。而且幾乎每個已啟用的站點都是如此，因為只要療法是新的，就會發生這種情況。

And I have to say and have to emphasize that even with those types of patients that have failed other therapies, we're talking about a 70% survival in that population, which I have to emphasize that's remarkable.

我必須說並且要強調，即便是在這類已經對其他療法失敗的病人，我們談的是該族群 70% 的存活率；我必須強調，這非常了不起。

But yesterday, we're starting to sort of notice a shift, especially with the mature centers, the mature sites that have been doing this now for over a year. These sites, everybody is already educated. Everybody is already has seen what I call the index case, the aha moment, the case that converted them and, in their mind, made them think, oh my gosh, we need to do this.

但昨天，我們開始注意到一個轉變，特別是在成熟中心、也就是已經做了一年多的成熟站點。在這些站點，每個人都已經受過教育。每個人也都已經看過我所稱的「指標案例」——那個「啊哈」時刻、那個讓他們改觀的案例，並在他們心中讓他們覺得：天啊，我們需要做這個。

And this is occurring and adoption -- clinical adoption mentally is occurring pretty universally across our mature sites. And so right now, as we speak, those clinicians are scanning their ICU to see who may benefit from the therapy.

而這正在發生——在我們的成熟站點中，臨床採用在心態上幾乎是普遍地發生。因此，就在我們說話的此刻，那些臨床醫師正在掃描他們的加護病房（ICU），看看哪些人可能會從這項治療中受益。

And so it's no longer now a rescue therapy. They're not waiting until the bitter end. They're starting these patients early, and we're seeing even better outcomes, which is just really remarkable. So that was my takeaway from the webinar. Again, we will make this available very soon.

所以現在它不再只是救援治療。他們不再等到最後關頭。他們開始更早為這些病人啟動治療，而我們看到更好的結果，這真的非常了不起。所以這就是我從研討會得到的重點。再次強調，我們很快就會提供回放。

And hopefully, you'll be able to watch it and verify my statement.

希望你們能夠觀看並驗證我的說法。

No, that's helpful, Kevin. Yes. So I mean, we know the focus as it should be, is on the pediatric market and now the adult AKI with this trial enrollment and you're at 223 up to 339. And we know it's adult AKI is 50 times larger than the pediatric market. But there's other markets that your cytopheretic device can treat, whether that be acute respiratory distress, hepatorenal syndrome, cardiorenal syndrome and of course, sepsis.

不，這很有幫助，Kevin。是的。所以我的意思是，我們知道重點——也確實應該如此——是在兒科市場，以及現在成人 AKI 的試驗收案，你們已從 223 進展到 339。而我們也知道，成人 AKI 的市場規模是兒科市場的 50 倍。但你們的細胞分離治療裝置還能治療其他市場／適應症，不論是急性呼吸窘迫症候群、肝腎症候群、心腎症候群，當然還有敗血症。

So I know you want to stay focused, like I said you should. But behind the scenes, can you give us some insight into what kind of work is being done on these other indications?

所以我知道你們想保持專注，就像我說的，你們應該如此。但在幕後，你能否讓我們了解一下，針對這些其他適應症正在進行哪些工作？

So I can tackle that one. Yes. I mean, yes, so we do obviously evaluate all the other applications that we believe that, obviously, from our perspective, there's a pretty long laundry list of things that really would be on our wish list. But obviously, we, as a company, have to be focused on certain things, and that's really been on QUELIMMUNE for pediatric AKI and adult AKI and NEUTRALIZE-AKI. Obviously, we've got the NEUTRALIZE-CRS study that's actually been funded by NIH.

我可以來回答這題。是的。我的意思是，是的，我們確實會評估所有其他應用；從我們的角度來看，顯然有一長串清單，都是我們希望能做的事情。但很明顯地，作為一家公司，我們必須聚焦在某些事項上，而這一直是聚焦在 QUELIMMUNE 的兒科 AKI 與成人 AKI，以及 NEUTRALIZE-AKI。當然，我們也有 NEUTRALIZE-CRS 研究，實際上是由 NIH 資助的。

And I would say we have various discussions with various parties looking at everything from non-dilutive to strategic discussions, business development on all these types of things to be able to really advance this -- the other indications that we believe we have in our pipeline. But obviously, it will just take time for some of those things to mature, and we'll just have to see how they pan out.

我會說，我們正與各方進行各種討論，涵蓋從非稀釋性資金到策略性討論、以及針對所有這些事項的商務開發，以便真正推進——我們認為在產品線中具備的其他適應症。但顯然，其中一些事情需要時間成熟，我們也只能看看最終會如何發展。

If I may just add really quickly. I should remind everyone that for NEUTRALIZE-AKI, a priority, we identify patients with ARDS at the time of enrollment and sepsis at the time of enrollment, and we randomize via this technique called block randomization. What that does is it allows equal distribution of subjects to be assigned in the ARDS bucket, in the sepsis bucket and the combined sepsis and ARDS bucket. We will be able to, for sure, make a statement about those specific populations who have concomitant AKI, of course.

如果我可以很快再補充一下。我應該提醒大家，對於 NEUTRALIZE-AKI（這是一項優先事項），我們在收案時會辨識同時有 ARDS 的病人，以及在收案時辨識敗血症病人，並透過一種稱為區組隨機化（block randomization）的技術進行隨機分派。這麼做可以讓受試者在 ARDS 組、敗血症組，以及敗血症合併 ARDS 組之間得到均衡分配。我們將能夠——確定地——針對這些特定族群（當然是同時合併 AKI 的族群）做出結論。

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

現在我想把電話交回給 Jackie Cossmon，請她做結語。

Thank you, Josh, and thank you all for joining us today for the SeaStar Medical Second Quarter Financial Results Conference Call. If you have questions, please contact us at ir@seastarmed.com or visit our website at www.seastarmedical.com. Thank you, and goodbye.

謝謝你，Josh，也謝謝各位今天參加 SeaStar Medical 第二季財務結果電話會議。如有問題，請透過 ir@seastarmed.com 與我們聯繫，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。本次會議到此結束。感謝各位的參與。您現在可以掛線。