Spectral AI Inc (MDAI) 2025 Q3 法說會逐字稿

Good day, and welcome to the Spectral AI Inc Q3 2025 financial results conference call. (Operator Instructions) Please note, this event is being recorded.

各位好，歡迎參加Spectral AI Inc 2025年第三季財務業績電話會議。 （操作說明）請注意，本次會議正在錄音。

I would now like to turn the conference over to Sara Prendergast, Assistant General Counsel. Please go ahead, ma'am.

現在我將會議交給助理總法律顧問薩拉·普倫德加斯特女士。請您發言，女士。

Thank you, Nick. Good afternoon, everyone, and thank you for joining us for Spectral AI's 2025 Third Quarter Financial Results Conference Call. Our speakers for today will be Dr. DiMaio, the company's Chairman of the Board; and Vincent Capone, the company's Chief Financial Officer. Before we begin, I'd like to remind everyone that during this call, certain statements made are forward-looking statements within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995, including statements regarding the company's strategy, plans, objectives, initiatives and financial outlook.

謝謝尼克。大家下午好，感謝各位參加Spectral AI 2025年第三季財務業績電話會議。今天發言的兩位是公司董事長迪馬約博士和財務長文森‧卡波內。在會議開始前，我想提醒大家，本次電話會議中某些陳述屬於1995年美國《私人證券訴訟改革法案》安全港條款所界定的前瞻性陳述，包括有關公司戰略、計劃、目標、舉措和財務展望的陳述。

When used in this call, the words estimates, projected, expects, anticipates, forecasts, plans, intends, believes, seeks, may, will, should, future, propose and variations of these words or similar expressions or the negative versions of such words or expressions are intended to identify forward-looking statements. These forward-looking statements are not guarantees of future performance, conditions or results and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside companies control that could cause actual results or outcomes to differ materially from those discussed in the forward-looking statements.

在本電話會議中，「估計」、「預期」、「預期」、「預測」、「計畫」、「打算」、「相信」、「尋求」、「可能」、「將」、「應該」、「未來」、「提議」等詞語及其變體或類似表達，以及這些詞語或表達的否定形式，旨在識別前瞻性陳述。這些前瞻性陳述並非對未來績效、狀況或結果的保證，並且涉及諸多已知和未知的風險、不確定性、假設和其他重要因素，其中許多因素不受公司控制，可能導致實際結果或業績與前瞻性陳述中所討論的內容存在重大差異。

As such, listeners are cautioned not to place undue reliance on any forward-looking statements. Investors should carefully consider the foregoing factors and the other risks and uncertainties described in the Risk Factors section of the company's filings with the SEC, including the registration statement and the other documents filed by the company. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements.

因此，聽眾應注意不要過度依賴任何前瞻性陳述。投資者應仔細考慮上述因素以及公司向美國證券交易委員會（SEC）提交的文件（包括註冊聲明和公司提交的其他文件）中「風險因素」部分所述的其他風險和不確定性。這些文件列明並闡述了其他可能導致實際事件和結果與前瞻性陳述中包含的內容有重大差異的重要風險和不確定性。

With that, I would like to turn the call over to Dr. DiMaio, Spectral AI's chairman of the Board.

接下來，我想把電話交給 Spectral AI 的董事會主席 DiMaio 博士。

Sara, thank you very much, and good afternoon to everyone. We appreciate you joining us today for our third quarter financial results conference call. I am quite pleased to discuss with you our results of operations through the third quarter of 2025. As I've mentioned on previous earnings calls, I follow a mantra here at Spectral AI of Finance, Focus and finish. I believe we are moving forward in all three phases as we complete our 2025 calendar year.

薩拉，非常感謝，大家午安。感謝各位今天參加我們第三季財務業績電話會議。我很高興與大家討論我們截至2025年第三季的營運表現。正如我在先前的財報電話會議上提到的，Spectral AI一直秉持著「財務、專注、完成」的理念。我相信，隨著我們順利完成2025年全年的工作，我們在這三個方面都取得了進展。

Following our FDA submission in the second quarter of 2025, we continue to work on developments in our DeepView system. I'd like to address additional developments in the third quarter of 2025 as following: number one, finance. Our cash balance has stayed flat at $10.5 million from the second quarter of 2025. We continue to monitor our operating efficiencies and had a number of stock option and warrant exercises that contributed to the continued high level of cash reserves at our company.

繼2025年第二季向FDA提交申請後，我們繼續推動DeepView系統的研發工作。我想就2025年第三季的其他進展做如下說明：第一，財務方面。自2025年第二季以來，我們的現金餘額一直維持在1,050萬美元。我們持續關注營運效率，並已行使了多項股票選擇權和認股權證，這些都為公司維持較高的現金儲備做出了貢獻。

On top of that, as announced in October, we completed an additional registered direct offering of our common stock adding $7.6 million of additional cash reserves to the company's balance sheet.

此外，正如我們在 10 月宣布的那樣，我們完成了額外的註冊直接發行普通股，為公司資產負債表增加了 760 萬美元的額外現金儲備。

With total cash on hand at the end of September 2025 of over $10 million, a closely managed spending rate and the additional funding from our registered direct offering, Spectral AI has a significant financing in hand for the foreseeable future that enables us to continue our work on our product commercialization efforts, including the planned US launch of our DeepView system next year.

截至 2025 年 9 月底，Spectral AI 的現金總額超過 1000 萬美元，加上嚴格控制的支出率以及透過註冊直接發行獲得的額外資金，公司在可預見的未來擁有充足的資金，使我們能夠繼續推進產品商業化工作，包括計劃明年在美國推出 DeepView 系統。

Number two, focus, which is the FDA submission. Our FDA submission, which was submitted in June of this year was a very big milestone in our company's development. I am proud of our team for their hard work and dedication in meeting that very important time line.

第二點，重點是FDA的申請。我們今年6月提交的FDA申請是我們公司發展歷程中的重要里程碑。我為我們團隊的辛勤付出和敬業精神感到自豪，他們按時完成了這項重要的任務。

The submission is obviously a key driver in the evolution of our business. We continue to have further interactions with the FDA on our de novo application, albeit somewhat slowed with the current US development -- US government shutdown that we're all experiencing. We continue to move forward with the de novo application full speed ahead as we have stated.

此次提交顯然是我們業務發展的關鍵驅動力。儘管目前美國政府停擺導致進展有所放緩，但我們仍在就全新療法申請與FDA保持溝通。正如我們之前所述，我們將繼續全力推動全新療法申請的進展。

Number three, finish. Lastly, finish is what we continue to focus on as we look to our BARDA partners to bring the DeepView system and the device to the commercial marketplace. We continue to focus on releasing next year and preparing to launch the commercialization strategy that we have discussed and will continue to refine as we move to that milestone.

第三，完成。最後，完成是我們持續關注的重點，我們期待與BARDA的合作夥伴攜手，將DeepView系統和設備推向商業市場。我們將繼續專注於明年的發布，並著手準備啟動我們已經討論過的商業化策略，隨著我們朝著這個里程碑邁進，我們將不斷完善該策略。

We continue to have a very broad application and indications that we seek in addition to burns for which we have a CPT 3 code and additional indications that will broaden the marketplace. We've had outstanding support from the burn community and at burn conferences with our abstracts being presented at national forums and publications and international publications.

除了目前已獲得 CPT 3 代碼的燒傷外，我們還在尋求其他適應症，以進一步擴大市場，並持續推進該療法在燒傷領域的廣泛應用。我們得到了燒傷領域和燒傷會議的大力支持，我們的摘要已在國家級論壇、出版物以及國際刊物上發表。

This further solidifies what's happening with our system in addition to the support that is receiving from the burn and the wound community at large. I thank you again for your attention to our company. And with that, I will turn things over to our Chief Financial Officer, Vince Capone. Vince?

這進一步鞏固了我們系統的運作，也反映了我們從燒傷和創傷護理領域中獲得的廣泛支持。再次感謝各位對我們公司的關注。接下來，我將把發言權交給我們的財務長文斯卡彭。文斯？

Thank you, Dr. DiMaio. Thank you all for joining us this afternoon. We issued our earnings release this afternoon, which contains additional details of our operating results, and we will be filing our Form 10-Q with the SEC later this week as well. With that in mind, I will focus my remarks on select highlights and key items.

謝謝迪馬約博士。感謝各位今天下午蒞臨。我們今天下午發布了盈利報告，其中包含我們營運表現的更多細節。我們也將在本週稍後向美國證券交易委員會提交10-Q表格。有鑑於此，我將重點介紹一些亮點和關鍵事項。

Our research and development revenue in the third quarter of 2025 was reduced to $3.8 million from $8.2 million in the third quarter of last year. This reduction reflects our anticipated reduced reimbursements under the BARDA Project BioShield contract, which was awarded to the company in September of 2023.

2025年第三季度，我們的研發收入從去年同期的820萬美元減少至380萬美元。這一減少反映了我們預計根據BARDA生物盾牌項目合約獲得的報銷款項減少，該合約於2023年9月授予本公司。

In the third quarter of 2025, following our FDA de novo submission, we have incurred less direct labor clinical trial and other reimbursed costs from the prior year's quarter. Gross margin decreased to 42.7% from 44.8% in the third quarter of last year due to a lower percentage of direct labor as a percentage of our total reimbursed costs under the BARDA Project BioShield contract from the prior year's quarter.

2025年第三季度，在我們向FDA提交全新療法申請後，我們發生的直接人工臨床試驗和其他報銷成本較去年同期有所減少。由於BARDA生物盾計畫合約下直接人工成本佔總報銷成本的比例較上年同期下降，毛利率從去年第三季的44.8%降至42.7%。

General and administrative expenses for the third quarter of 2025 were $5 million as compared to $4.6 million in the third quarter of 2024. This increase reflects increased third-party adviser and consulting costs and an increase in non-billable work that is not related to the BARDA Project BioShield contract. The company reported a net loss in the third quarter of 2025 of $3.6 million as compared to a net loss of $1.5 million in the prior year's third quarter, again reflecting the reduced research and development revenue and the higher general and administrative expenses from the prior year third quarter.

2025年第三季的一般及行政費用為500萬美元，而2024年第三季為460萬美元。這一增長反映了第三方顧問和諮詢費用的增加，以及與BARDA生物盾計畫合約無關的非計費工作量的增加。該公司報告稱，2025年第三季淨虧損360萬美元，而上年同期淨虧損150萬美元，這同樣反映了研發收入的減少以及一般及行政費用較上年同期有所增加。

Even with a $2.1 million increase in the net loss for the third quarter of 2025 as compared to the third quarter of 2024, the company is reporting a net loss of $8.6 million for the first nine months of 2025 as compared to a net loss of $7.4 million for the first nine months of 2024, reflecting our focus on managing our overall cost structure. At September 2025, we had 27,251,034 shares outstanding. Moving to our balance sheet.

儘管2025年第三季淨虧損較2024年第三季增加210萬美元，但公司2025年前九個月的淨虧損為860萬美元，而2024年前九個月的淨虧損為740萬美元，這反映了我們對整體成本結構管理的重視。截至2025年9月，公司流通股數為27,251,034股。接下來，我們來看資產負債表。

As Dr. DiMaio has previously noted, as of September 30, 2025, cash and cash equivalents totaled $10.5 million up from $5.2 million on December 31, 2024. Our cash balance has remained consistent since June 30, 2025. This is primarily due to the exercise of stock options and warrants in the third quarter of 2025 and our continued management of our operating expenses through the third quarter of 2025. Please note that this cash balance does not include the gross proceeds of $7.6 million of additional funding the company received in connection with our registered direct offering in October 2025.

如同迪馬約博士先前所述，截至2025年9月30日，本公司現金及現金等價物總額為1,050萬美元，高於2024年12月31日的520萬美元。自2025年6月30日以來，公司現金餘額一直保持穩定。這主要歸功於2025年第三季行使的股票選擇權和認股權證，以及我們在2025年第三季持續有效控制營運支出。請注意，該現金餘額不包括公司在2025年10月透過註冊直接發行獲得的760萬美元額外融資所得。

With our large cash reserves, our focused approach on managing our operational costs and expenses, we believe this level of funding is sufficient to provide the company with the necessary capital for the foreseeable future. For 2025, we are reducing our revenue guidance from $21.5 million to $18.5 million.

憑藉我們充裕的現金儲備以及對營運成本和費用的精準管控，我們相信目前的資金水準足以滿足公司在可預見的未來所需的資金需求。對於2025年，我們將營收預期從2,150萬美元下調至1,850萬美元。

The reduced revenue guidance reflects the anticipated reduced work on our BARDA Project BioShield contract since the submission to the FDA and some timing effect from the US government shutdown, which we believe will be largely made up within the first half of 2026. Also note that our guidance does not include the contribution of any sales of the DeepView system for the burn indication in the United Kingdom or in Australia.

下調的收入預期反映了自向FDA提交申請以來，我們BARDA生物盾計畫合約的工作量預計減少，以及美國政府停擺帶來的一些時間影響，我們相信這些影響將在2026年上半年基本得到彌補。另請注意，我們的預期不包括DeepView系統在英國或澳洲用於治療燒傷的銷售額。

Thank you for your time and attention today. And with that, operator, let's open up the call for questions from our analysts.

感謝您今天抽出寶貴時間收聽。那麼，接線員，現在讓我們開始接受分析師的提問。

Ryan Zimmerman, BTIG.

Ryan Zimmerman，BTIG。

This is Izzy on for Ryan. So Vince, I heard your commentary about the impact of the government shutdown and how that played into timing. But I was hoping you could provide a little bit more color around exactly what has been impacted and just confirm that everything is still on track for that expected first half '26 approval?

這裡是伊茲，替瑞恩發言。文斯，我聽到了你關於政府停擺的影響以及它如何影響審批時間的評論。但我希望你能更詳細地說明一下具體哪些方面受到了影響，並確認一切是否仍然按計劃進行，能否在2026年上半年獲得批准？

Sure. Izzy. Thanks for participating on the call. Yes, Izzy, we continue to see our FDA submission. We don't see any holdups in our FDA submission into 2026.

當然，伊茲。謝謝你參加電話會議。是的，伊茲，我們仍在按計劃向FDA提交申請。我們預計2026年之前不會有任何延誤。

Actually excited this week if we can get the government to lift the shutdown. But some of our conversations with BARDA, some of the conversations we have with their teams and the team involved with the continued development of our DeepView system, some of that has been delayed and ultimately, we just see it as a timing issue for the most part, understanding that nothing has changed with the delivery of what we hope and anticipate that we will get FDA clearance of our device in the first half of 2026 and also the continued work through the BARDA contract, which I'm sure you're aware, that runs through the end of the first quarter of 2026, at least the base phase. So no, other than that, I mean, it's just really a general slowdown in work with our BARDA partners. I hope that answered your question.

如果本周政府能夠解除停擺，我其實還挺興奮的。但是，我們與BARDA（生物醫學高級研究與發展局）的一些溝通，以及我們與他們的團隊和參與DeepView系統持續研發的團隊的溝通，都受到了一些影響。最終，我們認為這主要是時間安排上的問題。我們預計，我們的設備將在2026年上半年獲得FDA的批准，這並沒有改變我們交付的計畫。此外，我們與BARDA的合約工作也在繼續進行，我相信您也知道，該合約至少在基礎階段會持續到2026年第一季末。所以，除此之外，我的意思是，我們與BARDA合作夥伴的工作確實普遍放緩了。希望我的回答能解答您的問題。

Yes, it does. It's helpful. And I know it's early to think about guidance for 2026, but you did mention the expectation that some of this revenue will be made up next year. So I was curious if you could provide even some qualitative commentary about the cadence or pacing of that for next year.

是的，確實很有幫助。我知道現在考慮2026年的業績指引還為時過早，但您確實提到預計部分收入將在明年得到彌補。所以我很好奇您能否就明年的進度或節奏提供一些定性方面的說明。

Sure. As well, Izzy, ultimately, we have always projected that 2026 will be, in general, a down year on revenue from where we were in 2024 and in 2025. Our current forecast shows relatively flat between 2025 and 2026. There might be a small reduction in overall revenue. Still working through that and obviously, there's a number of assumptions built in there.

當然。另外，伊茲，我們一直預測，2026 年的收入總體上會比 2024 年和 2025 年有所下降。我們目前的預測顯示，2025 年至 2026 年之間營收將相對持平。總收入可能會略有下降。我們仍在研究這個問題，而且顯然，其中也包含一些假設。

But I would anticipate 2026 to look -- from a revenue standpoint, probably somewhat lower than it is in 2025, but I don't know that materially it will be much different. But that's a turn year for us as we look to commercialize the device and then we see '27 and obviously, '28 to be significant years for the company's growth.

但我預計2026年的收入可能會比2025年略低，但實際上不會有太大差異。不過，2026年對我們來說是一個轉捩點，因為我們將著手實現設備的商業化。我們認為2027年和2028年將是公司發展的重要年份。

That's helpful. And then last one for me. I know there are several units that are placed in international markets. I was curious what some of the feedback has been from those sites and how you're using that to inform your preparations for the US launch?

這很有幫助。最後一個問題。我知道你們在一些國際市場投放了產品。我想知道這些地區的用戶回饋如何，以及你們如何利用這些回饋來指導美國市場的上市準備？

Yes. If you mind, I'll take that question. Thanks for that question, which, of course, for me, as a clinician, is terribly important. The answer is the feedback we've gotten from the units in the -- outside the US have been overwhelmingly positive.

是的。如果您不介意，我就回答這個問題吧。謝謝您的提問，當然，對我這個臨床醫師來說，這個問題非常重要。答案是，我們從美國以外的醫療機構收到的回饋絕大多數都是正面的。

The comments include that it's easy to use, very helpful and even a number of papers and abstracts have been in publication or published to document this in addition to the verbal feedback that we've gotten as well. So the answer is you've also used some of that feedback in terms of certain changes or minor adjustments in the device that we plan to incorporate with the next iteration in our Phoenix device.

評論中提到它易於使用、非常實用，甚至還有一些論文和摘要已經發表或正在發表，以記錄這一點，此外我們也收到了許多口頭回饋。所以答案是，我們也根據這些回饋對設備進行了一些更改或細微調整，我們計劃將這些變更或調整應用到下一個版本的Phoenix設備中。

So in summary, we have been -- the device has been very positively received. It's been easy to use with both physicians and nonphysician health care providers and has really facilitated the care burn patients outside the United States.

總而言之，這款設備反應非常好。無論是醫生或非醫生醫護人員，都能輕鬆上手使用，它確實大大便利了美國以外地區燒傷患者的照護。

Carl Byrnes, Northland Capital Markets.

卡爾拜恩斯，北地資本市場。

Congratulations and thanks for the question. I'm just wondering how your communications with the FDA have been progressing? And has there been any additional requests or outstanding items with respect to the filing or has it been a relatively clean and clear exchange? And then I have one quick follow-on.

恭喜，也感謝您的提問。我想了解一下您與FDA的溝通進度如何？關於申請資料，是否有任何補充要求或未決事項？還是溝通一直都很順利？最後，我還有一個後續問題。

Yes. Thank you. This is Dr. DiMaio. Thanks for that question because as you say, this is the second part that I mentioned, the focus of FDA.

是的，謝謝。我是迪馬約博士。感謝您的提問，正如您所說，這正是我提到的第二部分，即FDA的關注重點。

And the answer is we've had very, very frequent and good communications with the FDA. There are obviously certain adjustments and questions that they have for us and additional matters. I would be -- probably couldn't or shouldn't discuss those publicly, that would probably violate some of the FDA's requirements. But suffice it to say, we've had very good communications.

答案是，我們與FDA一直保持著非常頻繁且良好的溝通。顯然，他們有一些調整意見、問題需要我們提出，還有一些其他事項。我可能無法或不應該公開討論這些，因為這可能會違反FDA的一些規定。但總而言之，我們之間的溝通非常順暢。

One of the most important aspects is the statistical analysis plan or the SAP, which, of course, is the guts of the artificial intelligence algorithm, and that's been very favorably received. And so that was what I was personally most concerned about, and that seems to have gone very, very well.

最重要的方面之一是統計分析計劃（SAP），它當然是人工智慧演算法的核心，而且這方面也受到了非常積極的評估。所以，這正是我個人最關心的部分，而現在看來，這方面進展得非常順利。

Our data science team has done an outstanding job. There's some other testing we'll be looking at, whether there's additional human factors studies or additional reliability testing that we're discussing with the FDA right now, and we're getting clearance and clarity on that. And once we complete that, we anticipate we'll move ahead forward. But in summary, we've got good interaction. We provided additional information, and we literally have calls scheduled in the next couple of weeks with the FDA for further clarification.

我們的數據科學團隊做得非常出色。我們也會進行一些其他測試，例如是否需要進行額外的人體因素研究或可靠性測試，目前我們正在與FDA討論，並正在尋求他們的批准和明確答案。一旦完成這些測試，我們預計會繼續推進專案。總而言之，我們與FDA的溝通非常順暢。我們提供了補充信息，並且已經安排了未來幾週與FDA的電話會議，以進一步澄清相關問題。

Great. Perfect. Excellent. That's -- and just one quick follow-up. With respect to Snapshot, is there any update on the development of the handheld module?

太好了。完美。棒極了。就這些了——還有一個小問題。關於Snapshot，手持模組的開發有什麼最新進展嗎？

Good question. So thank you for that question as well, the handheld. And the answer is a big yes. Additional development is going on that. As you know, that's primarily a military project sponsored by the military, and we have got good feedback that they have like the preliminary design of the handheld device and is currently going through testing and environments that the military requires us to perform, including high temperatures and low temperatures as well.

問得好。感謝您提出的關於手持設備的問題。答案是肯定的，我們正在進行進一步的研發。如您所知，這主要是一個由軍方資助的軍事項目，我們已經收到了他們積極的回饋，例如手持設備的初步設計。目前，該設備正在接受軍方要求的各種測試環境，包括高溫和低溫環境。

And so we have gotten and we are seeking additional support, which is -- we plan to be forthcoming from the US military to continue to develop that device for military use. In a parallel fashion, we're having discussions to have the same form factor or simpler form factor for the military for civilian use, and that's active as well.

因此，我們已經獲得並正在尋求更多支持，也就是說，我們計劃繼續從美國軍方獲得資金，以繼續開發該設備用於軍事用途。同時，我們也積極探討將相同或更簡單的外形設計應用於民用領域，這項工作也正在進行中。

So the answer is that we are moving forward with the military as the background of the basis to be able to develop a civilian application with a very similar device. But I want to emphasize to you as well as anybody else that we do anticipate at least in the short or midterm to have the cart-based device, because, of course, that's what BARDA has paid us to do.

所以答案是，我們正以軍方經驗為基礎，推進開發一款非常相似的民用設備。但我還要向各位強調，我們預計至少在短期或中期內會推出推車式設備，因為這正是BARDA委託我們所進行的工作。

It's very easily used in the burn units. It's larger in the operating room, in the emergency room and so forth and we see the handheld unit as complementary or additive and not necessarily replacing the cart-based device. As well, please know that we plan for the cart-based device to be the basis for a 510(k) application for the handheld device. So there's similar technology, similar camera, et cetera. So it will simplify the progression of our technology from cart-based to hand based.

它在燒傷病房非常易於使用。在手術室、急診室等場所，它體積較大。我們認為手持式設備是推車式設備的補充或增強，而非取代。此外，請知悉，我們計劃以推車式設備為基礎，為手持式設備申請 510(k) 認證。因此，它們採用類似的技術，配備類似的攝影機等等。這將簡化我們技術從推車式到手持式的過渡。

Great. Very helpful. And again, the handheld is funded through MTech and DHA. Correct?

太好了，很有幫助。還有，這款手持裝置是由MTech和DHA資助的，對嗎？

That's correct. Yes, sir. I've been deemphasizing that not to deemphasize it because of the military per se, but also emphasize that we're looking at the civilian market as well. But yes, the current diversion is funded by division, the Department of Defense called MTech and DHA. That is correct.

沒錯。是的，長官。我一直淡化這一點，並非因為軍方本身，而是為了強調我們也在關注民用市場。是的，目前的轉移計畫是由國防部下屬的MTech和DHA部門資助的。沒錯。

John Vandermosten, Zacks SCR.

John Vandermosten，Zacks SCR。

Great. I'd like to start out with just getting a sense of your commercialization preparation activities and ask if you're planning to hire perhaps a Chief Commercial Officer or Chief Operations Officer? And then also along that same line, what efforts are being made, I guess, in terms of market access, distribution, marketing and launch execution over the next few months coming up on the target action date?

好的。我想先了解貴公司在商業化準備方面的工作，例如是否計劃招募商務長或營運長？另外，我想了解一下，在即將到來的幾個月裡，也就是目標上市日期臨近之際，貴公司在市場准入、分銷、營銷和產品上市執行方面都做了哪些努力？

John, that's a great question and I appreciate it. And of course, that's the third half, which is finished. So in no particular order, we already have a person who is a commercialization person right now on board, and he's working to process all this as well. We have in the budget for 2026, four more people, four more FTEs that we're talking about bringing on board shortly to be able to have Salesforce and other parts of what we call professional education as well. Please note as well that the BARDA budget includes some of those costs, which helps us defray some of the costs in the initial stages of commercialization.

約翰，你問得好，謝謝。當然，這是第三部分，已經完成了。接下來，我們團隊目前已經有一位負責商業化的人員，他正在處理所有這些事宜。在2026年的預算中，我們計劃盡快增聘四名員工（四個全職員工），以便能夠開展Salesforce以及其他我們稱為專業教育的項目。另外，請注意，BARDA的預算也包含了部分費用，這有助於我們支付商業化初期的一些成本。

The next part of that, of course, is that we're talking about the burn community, which as you know from our research studies, there's 137 burn units in the United States, and there's a large number that are participating in our research trials so I would think or argue that we have got a very good leg up on the community for which we intend to do. The first sales are quite well aware of the technology and are quite excited about getting it in their hands as soon as it's federally clear from the FDA.

當然，接下來我們要談的是燒傷患者族群。正如您從我們的研究中了解到的，美國有137家燒傷中心，其中許多都參與了我們的研究試驗。所以我認為，或者說，我們在這個目標群體中已經佔據了非常有利的地位。首批銷售人員對這項技術非常了解，並且非常期待在獲得FDA批准後儘快使用。

And lastly, and maybe as importantly, is that the BARDA contract, once we get FDA clearance includes clauses to help begin the placement of these devices and the burn centers and beyond. So in answer, I think we have a very good foundation with people, funding in place to start the commercialization rollout, and we will be ramping up as well to make that happen.

最後，或許同樣重要的是，BARDA合約中包含的條款，一旦我們獲得FDA批准，就能幫助我們開始在燒傷中心及其他場所部署這些設備。所以，我認為我們已經擁有非常良好的基礎，人員和資金都已到位，可以啟動商業化推廣，我們也將加快步伐，確保目標的實現。

Okay. That's good. And you had several presentations at the European Burn Association. And I was wondering how they were received by the audience and who the audience was? I know it was in Europe. I think it was in Germany. Is this allowing you to push further east, I guess, from the UK to get more health groups interested in using the device?

好的，很好。您在歐洲燒傷協會做了幾場演講。我想知道聽眾的反應如何，聽眾群是怎麼樣的？我知道是在歐洲，好像在德國。這是否讓您能夠從英國向東拓展，吸引更多醫療機構對使用該設備感興趣？

Yes, sir, John. Again, another great question. Thanks for that. And so the answer is that there were burn meetings both in the UK and in Germany, of which members of the burn communities there as well as members from the US burn community participated. We had presentations at all those meetings. And again, not because I'm prejudiced, we had outstanding reception from those presentations and a big, big request, how soon will they be in those areas. Again, we already have units placed in the UK. And literally today, we had discussions about expanding into the European market, both Western and Eastern and those discussions are forthcoming.

是的，約翰先生。又是一個好問題，謝謝。答案是，我們在英國和德國都舉辦了燒傷會議，當地的燒傷患者群體以及美國的燒傷患者群體都參加了。我們在所有這些會議上都做了報告。再次強調，我並非出於偏見，但我們的報告反應非常好，大家也強烈詢問我們的設備何時才能在這些地區投入使用。目前，我們已經在英國部署了設備。就在今天，我們也討論了拓展歐洲市場（包括西歐和東歐市場）的事宜，相關討論即將展開。

We plan to progress further with getting clearance from UKCA and CE Mark as well. The current device in the UK is going to be upgraded and based upon what we've learned in the US market and from the FDA. So in summary, yes, we do plan to expand into the UK and parts of Europe and maybe even beyond that. But our primary focus for right now, of course, is the US. But yes, the secondary and tertiary focus will be outside the US.

我們計劃繼續推進UKCA和CE認證的申請。目前在英國銷售的設備將會升級，升級內容將基於我們在美國市場和FDA所獲得的經驗。總而言之，是的，我們計劃拓展英國和歐洲部分地區，甚至可能更遠。但目前我們的首要任務當然是美國市場。不過，美國以外的市場將是我們的第二和第三重點。

Okay. Got it. And last question for me is on the Spectral IP transaction. I know that has been announced, and I haven't seen anything and wanted to know if that was -- or what the status of that was?

好的，明白了。我的最後一個問題是關於Spectral IP的交易。我知道已經宣布過了，但我還沒看到任何消息，想知道這件事的進展如何？

Vince?

文斯？

Thank you, Dr. DiMaio. Yes, I'll take this one. John, good to hear from you. Thanks for participation today.

謝謝迪馬約醫生。好的，我接受這個任務。約翰，很高興收到你的消息。感謝你今天的參與。

Yes, the Spectral IP and the SIM IP transaction that's currently working through the SEC. And I would anticipate that those filings will be reviewed with an eye towards my understanding as of today is that I would expect that transaction to close probably in the first quarter of 2026. And I would expect that you'll see something in our financials probably in the first quarter of 2026, reflecting that transaction.

是的，Spectral IP 和 SIM IP 的交易目前正在通過美國證券交易委員會 (SEC) 的批准。我預計這些文件將會被審查，根據我目前的了解，我預計該交易可能會在 2026 年第一季完成。我預計你們會在 2026 年第一季的財務報表中看到反映該交易的內容。

That concludes our question-and-answer session. I would like to turn the conference back over to Dr. DiMaio for any closing remarks.

問答環節到此結束。現在我把會議交還給迪馬約博士，請他作總結發言。

Thank you again for your participation and continued interest In Spectral AI. We are very pleased with the progress, as I described with the three Fs, and we continue to make remain optimistic about our prospects for growth. We continue to work hard on the three principles that I outlined, and we look to have further announcements on our progress with these goals in the very near term. I thank everyone on the call and wish you a very good evening.

再次感謝您參與並持續關注Spectral AI。正如我之前提到的「三大要素」（3F）所展現的，我們對所取得的進展感到非常滿意，並且對未來的發展前景依然保持樂觀。我們將繼續努力實踐我先前闡述的三大原則，並期待在近期內就這些目標的進展發布更多公告。感謝各位參加本次電話會議，祝您晚安。

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

會議已結束。感謝您參加今天的報告。您可以斷開連線了。