Talphera Inc (TLPH) 2026 Q1 法說會逐字稿

Welcome to the Talphera first-quarter 2026 financial results conference call. This call is being webcast live via the Events page of the Investors section of Talphera's website at www.talphera.com. You may listen to a replay of this webcast by going to the Investors section of Talphera's website. I would now like to turn the call over to Raffi Asadorian, Talphera's Chief Financial Officer. Please go ahead.

歡迎參加 Talphera 2026 年第一季財務業績電話會議。本次電話會議將透過 Talphera 官網 www.talphera.com「投資人」專區中的「活動」頁面進行即時網路直播。您可前往 Talphera 官網「投資人」專區收聽本次網路直播的重播。現在我想把電話會議交給 Talphera 財務長 Raffi Asadorian。請開始。

Thank you, and thank you for joining us on the call today. Today, we announced our first-quarter 2026 financial results and associated business updates in a press release. With me today are Vince Angotti, our Chief Executive Officer; and Dr. Shakil Aslam, Talphera's Chief Medical Officer. Before we begin, I want to remind listeners that during this call, we will likely make forward-looking statements within the meaning of the federal securities laws.

謝謝，也感謝各位今天加入我們的電話會議。今天，我們已透過新聞稿公布 2026 年第一季財務業績及相關業務更新。今天與我一同出席的有我們的執行長 Vince Angotti，以及 Talphera 的醫務長 Shakil Aslam 醫師。在開始之前，我想提醒各位聽眾，本次電話會議中我們可能會依據聯邦證券法的定義作出前瞻性陳述。

These forward-looking statements involve risks and uncertainties regarding the operations and future results of Talphera. Please refer to our press release in addition to the company's periodic current and annual reports filed with the SEC for a discussion of the risks associated with such forward-looking statements. These documents can also be found on the website within the Investors section. I'll now hand the call over to Vince.

這些前瞻性陳述涉及與 Talphera 營運及未來業績相關的風險與不確定性。請參閱我們的新聞稿，以及公司向美國證券交易委員會（SEC）提交的定期當期報告與年度報告，以了解與此類前瞻性陳述相關的風險討論。這些文件亦可在本公司網站「投資人」專區中查閱。接下來我把電話交給 Vince。

Thanks, Raffi. Good afternoon, and thank you to everyone joining our call today. It's been less than two months since our last update, and we're excited about the progress we've made this year in the NEPHRO study with our ongoing enrollment at current clinical study sites, activation of additional sites, achievement of the 50% enrollment milestone and consequently, the closure of an additional financing tranche. With this continued progress, we believe we are well positioned to complete enrollment in the NEPHRO CRRT Study this year and file the PMA for a targeted potential approval of Niyad in 2027. As mentioned, in early March, we announced the attainment of the 50% enrollment milestone in the NEPHRO study.

謝謝，Raffi。各位下午好，感謝大家今天加入我們的電話會議。距離我們上次更新還不到兩個月，我們對今年在 NEPHRO 研究所取得的進展感到振奮，包括在現有臨床試驗中心持續收案、啟動更多中心、達成 50% 收案里程碑，並因此完成額外一筆融資分期款的交割。隨著這些持續進展，我們相信我們已具備良好條件在今年完成 NEPHRO CRRT 研究的收案，並提交 PMA，以期在 2027 年針對 Niyad 的潛在核准。如先前所提，3 月初我們宣布已達成 NEPHRO 研究 50% 收案里程碑。

With continued enrollment since that date, I'm pleased to report that we have well exceeded this level. The protocol changes we adopted last year, supported by bringing on new target profile clinical study sites have positioned us to achieve our goal of completing the study this year.

自該日期以來持續收案，我很高興地報告，我們已大幅超越此一水準。我們去年採納的試驗方案變更，加上新增符合目標特徵的新臨床試驗中心，使我們得以朝今年完成研究的目標邁進。

Building on our virtual investor and analyst event in March, we continue to be genuinely excited about completing the study and submitting our PMA for potential approval of Niyad. The KOLs who participated in our March event highlighted the disadvantages with the currently available anticoagulants they're using and their belief that nafamostat will fill an unmet need in this market. These insights as well as our ongoing discussions with other nephrologists further reinforce our belief that Niyad could have an important role in anticoagulation for CRRT, if approved by the FDA.

延續我們 3 月舉辦的線上投資人與分析師活動，我們仍對完成研究並提交 PMA、以爭取 Niyad 的潛在核准感到由衷振奮。參與 3 月活動的關鍵意見領袖（KOL）指出他們目前使用的抗凝血劑存在缺點，並認為 nafamostat 將可填補此市場的未被滿足需求。這些洞見以及我們與其他腎臟科醫師的持續討論，進一步強化我們的看法：若獲 FDA 核准，Niyad 可在 CRRT 的抗凝治療中扮演重要角色。

9 of our 12 activated sites aligned with the new target site profile that we set last year. And with nephrologists as the lead, these sites have enrolled over 90% of the patients in the study. The quality of our study sites and the principal investigators and their teams is excellent. Dr. Aslam and I have been actively visiting many of the sites over the past several weeks, and all of them are highly engaged and have expressed their desire to have a new CRRT anticoagulant approved for use.

我們已啟動的 12 個中心中，有 9 個符合我們去年設定的新目標中心特徵。在腎臟科醫師主導下，這些中心已收納本研究超過 90% 的受試者。我們的研究中心品質，以及主要研究者與其團隊的表現都非常出色。過去幾週 Aslam 醫師與我積極走訪多個中心，所有中心都高度投入，並表達希望能有新的 CRRT 抗凝血劑獲准使用。

In addition, we look forward to welcoming a couple of additional institutions who have been enthusiastic to participate in the study, allowing us to maximize the 14 sites granted by the FDA. While these new sites will find us further along in enrollment, they've been drawn to the NEPHRO study by a deep appreciation for nafamostat's nearly four decades of use outside the US and a strong interest in contributing to the US research with their peers on a potentially new approved CRRT anticoagulant. Adding these final sites helps lay the groundwork for broader clinical awareness of nafamostat, which will serve us well, if the FDA approves it next year.

此外，我們也期待迎接另外幾家對參與研究充滿熱忱的機構加入，使我們能充分運用 FDA 核准的 14 個中心名額。雖然這些新中心加入時我們的收案已進行到較後期，但他們之所以被 NEPHRO 研究吸引，是因為深刻認同 nafamostat 在美國以外地區近四十年的使用經驗，並對與同儕共同投入美國研究、推動可能成為新獲准 CRRT 抗凝血劑的工作抱持高度興趣。加入這些最後的中心有助於為 nafamostat 建立更廣泛的臨床認知；若 FDA 明年核准，這將對我們非常有利。

With that, I'll now hand the call over to Raffi to update you on the financial results for the first-quarter.

接下來我把電話交回 Raffi，向各位更新第一季的財務業績。

Thank you, Vince. Our cash balance at March 31, 2026, was $21.1 million. We believe this cash combined with future conditional financing tranches will provide us sufficient capital through at least a potential Niyad PMA approval expected next year.

謝謝，Vince。截至 2026 年 3 月 31 日，我們的現金餘額為 2,110 萬美元。我們認為，這筆現金加上未來具條件的融資分期款，將可為我們提供充足資金，至少支應至預期於明年取得 Niyad PMA 潛在核准為止。

During the quarter, we closed a $4.1 million financing tranche from the March 2025 private placement. There are two remaining conditional financing tranches totaling approximately $16 million of additional capital, which if the conditions are met, are expected to close around the date we release our top line data and announce completion of the study later this year.

本季期間，我們完成交割一筆來自 2025 年 3 月私募的 410 萬美元融資分期款。尚有兩筆具條件的融資分期款，合計約 1,600 萬美元的額外資金；若條件達成，預期將於我們在今年稍晚發布主要（top line）數據並宣布研究完成的前後完成交割。

Our cash operating expenses or combined R&D and SG&A expenses for the first-quarter of 2026 totaled $3.9 million compared to $2.9 million for the first-quarter of 2025. Excluding non-cash stock-based compensation expense, these amounts were $3.7 million for the first-quarter of 2026 compared to $2.7 million for the first-quarter of 2025. The increase in cash operating expenses in the first-quarter of 2026 was primarily due to higher Niyad development expenses, reflecting increased enrollment and an increase in certain G&A expenses. I'll now turn the call back over to Vince.

2026 年第一季我們的現金營運費用（即研發費用與銷售、一般及行政費用（SG&A）合計）為 390 萬美元，較 2025 年第一季的 290 萬美元增加。若排除非現金的以股份為基礎之薪酬費用，2026 年第一季為 370 萬美元，較 2025 年第一季的 270 萬美元增加。2026 年第一季現金營運費用增加，主要由於 Niyad 開發費用較高，反映收案增加，以及部分一般及行政（G&A）費用上升。接下來我把電話交回 Vince。

Thank you, Raffi. I'd now like to open the line for any questions you might have. Operator?

謝謝，Raffi。現在我想開放線路，回答各位可能有的問題。接線員？

(Operator Instructions)

（接線員指示）

James Molloy, Alliance Global Partners.

James Molloy，Alliance Global Partners。

Matt on for Jim today. I was just wondering, if you guys are going to announce enrollment and any other milestone, maybe 75%? Or is the next update going to be full enrollment and then where to expect data quickly after?

今天由 Matt 代替 Jim 發言。我只是想請教一下，你們是否會公布入組進度以及任何其他里程碑，例如達到 75%？還是下一次更新會是完成全部入組，然後之後多久可以預期很快看到數據？

Yes, Raffi, I'll start it, and then you can give them an idea of kind of the data communication we're planning. So we're not planning on any additional enrollment updates, in particular, realizing that the balance of the study isn't tied to any tranches until the closure of the study until the study is being completed. With that said, I think Raffi can communicate to you what our expectation is upon study completion, or enrollment completion being last patient out and how we plan to communicate data thereafter.

是的，Raffi，我先回答，然後你可以讓他們了解一下我們計畫如何溝通數據。所以我們不打算再提供任何額外的入組更新，特別是考量到研究其餘部分並不與任何分期（tranches）掛鉤，直到研究結束、研究完成為止。話雖如此，我想 Raffi 可以向你說明我們對研究完成、或入組完成（即最後一位受試者完成退出）時的預期，以及之後我們打算如何對外溝通數據。

Yes, sure. Yes, I think we'll announce last patient out. But the most important is the top line data, which should come within a month after that last patient out. Remember, it's a very quick study, 72 hours at the secondary endpoint, 24-hour primary endpoint. So it's a quick study, and we're cleansing the data along the way. So it will be a quick announcement for that top line data.

好的，當然。是的，我想我們會公布最後一位受試者完成退出（last patient out）。但最重要的是頂線數據（top line data），應該會在最後一位受試者完成退出後的一個月內出來。請記得，這是一個非常快速的研究，次要終點是 72 小時，主要終點是 24 小時。所以這是一個快速研究，而且我們會在過程中同步進行數據清理。因此頂線數據會很快公布。

Got it. And is there any guidance you can give as to where you might be now or timing going forward, second half '26 still looking like the most likely for a top line read?

了解。那麼你們是否能提供任何指引，說明目前可能進行到哪裡，或是未來時程方面，2026 年下半年仍然看起來最有可能讀出頂線結果嗎？

Yes, the second half of '26. The study goes in ebbs and flows. And so we're going to remain in our guidance for the second half of 2026, depending on the flow of those qualifying patients moving forward, but we're confident in being completed this year and announcing those results this year.

是的，2026 年下半年。研究進度會有起伏（ebbs and flows）。因此我們會維持 2026 年下半年的指引，這取決於未來符合條件的患者流入情況；但我們有信心能在今年完成並在今年公布那些結果。

Ed Arce, West Capital.

Ed Arce，West Capital。

Congrats on the continued progress. Just a couple of quick questions for me as we anxiously await full enrollment and top line data later this year. The first one is these two new sites that you expect to come online pretty soon here and basically cap out the full complement of sites.

恭喜你們持續取得進展。在我們焦急等待今年稍晚完成全部入組與頂線數據之際，我這邊有兩個簡短問題。第一個是你們預期很快會啟用的兩個新中心，基本上會把研究中心數量補齊到完整配置。

Would you be able to disclose which sites those are or perhaps give a qualitative description of the type of site and the type of patients that they see? And then the other question is, have you received any commentary from site administrators that are treating the patients, anyone that is conducting the study? Any commentary that you could share with us about how things are progressing?

你們能否透露那兩個中心是哪裡，或至少用定性方式描述一下中心類型以及他們所收治的患者類型？另外一個問題是，你們是否收到任何來自中心管理者（site administrators）、治療患者的醫護人員或執行研究者的回饋？有沒有任何你們可以與我們分享的評論，關於進展情況如何？

Yes. I'll start with the new sites, Ed, and then I'll turn it over to Shakil to give a little more insight on those sites and the site administrators feedback. The two new sites, we don't expect to be significant contributors to the study, but they have significant CRRT populations. I say not to be significant contributors to the study because they're coming in so late to the study, but they wanted to be involved moving forward. These are study sites that match our new profile with nephrologists being the lead.

好的。Ed，我先談新中心，然後再交給 Shakil，讓他就這些中心以及中心管理者的回饋提供更多見解。這兩個新中心我們預期不會對研究入組做出重大貢獻，但他們有相當可觀的 CRRT（連續性腎臟替代治療）族群。我之所以說不會是重大貢獻者，是因為他們加入研究的時間點很晚，但他們希望未來能參與。這些研究中心符合我們新的中心輪廓：由腎臟科醫師擔任主要負責人（lead）。

One of the sites in particular is one of the top five as far as our data suggests CRRT administering hospitals in the country. And we'll end up communicating those sites when we update federalgov.com on the study sites. So you'll be able to see who those sites are specifically in conjunction with all the balance of the sites we have to round out the 14.

其中有一個中心，依我們的數據顯示，就 CRRT 執行量而言，是全國前五大的醫院之一。當我們更新 federalgov.com 上的研究中心資訊時，也會同步對外溝通這些中心。因此你將能看到這些中心的具體名稱，並且與我們其餘中心一起，湊齊總數 14 家。

As it relates to the site administrators and how it's going, I think Shakil is best positioned to communicate that while he and I have been making a rounds over the last several weeks. Remember, it's a blinded study, but I think what's important about this is the placebo and the product are treated similar in the protocol and the simplicity that comes with it. So Shakil?

至於中心管理者的回饋以及進展如何，我認為 Shakil 最適合來說明，因為過去幾週他和我一直在各中心巡訪。請記得，這是一項盲性研究，但我認為重要的是：在試驗流程中，安慰劑與產品的處置方式相同，而且流程很簡單。所以，Shakil？

Sure. Thanks, Ed. Absolutely. So when we talk to the PIs and the investigators and then as well as the nurses who are running this study and who are doing testing and looking at some of the test results, they are all very, very impressed with the ease of administering this intervention, as Vince said, both placebo as well as Niyad, they are administered exactly the same way. And sure for first 24 hours, we have a little bit more intense monitoring of blood test to see how patients are responding to it.

好的。謝謝你，Ed。當然。所以當我們與主要研究者（PIs）和研究人員，以及負責執行本研究的護理人員（他們也會做檢測並查看部分檢測結果）交流時，他們都對這項介入措施的給藥便利性印象非常、非常深刻。正如 Vince 所說，無論是安慰劑或 Niyad，給藥方式完全相同。而且在最初 24 小時內，我們會更密集地監測血液檢測，以觀察患者對其反應。

But after 24 hours, that intensity goes down. And they basically all are very, very impressed that how little variability they are seeing in the test results. So that's quite a pleasant surprise to them that they don't have to chase their tails trying to keep some -- the parameters within a target range. Once they have somebody stable at a parameter lab parameter, they basically stay at the same value. So overall, I think everybody is.

但 24 小時後，監測強度就會下降。而且他們基本上都對檢測結果中所看到的變異性非常、非常小感到印象深刻。因此這對他們來說是相當令人驚喜的，因為他們不需要疲於奔命地把某些——參數維持在目標範圍內。一旦某位患者在某個實驗室參數上達到穩定，他們基本上就會維持在同一數值。所以整體而言，我認為大家都……

Shakil, can you comment on the reach or the conclusion of that stability to get to the proper dose in that first hour and why that protocol works for them and how we're basically controlling that primary endpoint on that first hour.

Shakil，你能否評論一下：在第一個小時內達到適當劑量所帶來的穩定性之幅度或結論，以及為什麼該流程對他們有效，還有我們如何在第一個小時控制那個主要終點？

Right. So as you know, this study, we start at a starting dose, which is predefined. And 15 minutes later, we check the activated clotting time by a handheld device by the bedside, which we provide and we provide the cartridges as well. So it's pretty standardized test across all sites. And within 15 minutes, they check the value, and we have a certain range in which we want that value to be.

好的。如你所知，在這項研究中，我們從一個預先定義的起始劑量開始。15 分鐘後，我們會使用床邊的手持裝置測量活化凝血時間（activated clotting time），該裝置由我們提供，試片（cartridges）也由我們提供。因此在所有中心之間，這是一個相當標準化的檢測。在 15 分鐘內他們就會檢查數值，而我們希望該數值落在某個特定範圍內。

So about 70% of the cases, you see the ACT going in that range right at the first starting dose. Occasionally, a patient rest 25% may need one and a couple of them may have needed even more than 1 titration, 2 titrations, which is by the end of first hour, everybody is in the range in which they are expected to be. Obviously, I'm not going to disclose the different groups because there's one placebo in which we don't expect the value to change much. But as expected, the value doesn't change, in active treatment the value changes. But they remain within that range.

因此大約 70% 的案例中，你會看到 ACT 在第一次起始劑量時就落在那個範圍內。偶爾，剩下 25% 的病人可能需要再調整一次，而其中有一兩位甚至可能需要超過一次的滴定、兩次滴定；到第一個小時結束時，所有人都會落在他們預期應該達到的範圍內。顯然，我不會揭露不同組別，因為其中有一個安慰劑組，我們不預期數值會有太大變化。但如預期，該數值在安慰劑組不會改變；在主動治療組，數值會改變。但它們仍維持在那個範圍內。

So it's a very, very stable response. And which is not a total surprise to us because nafamostat metabolism is really not dependent on any specific organ. So there are other drugs which either depend on liver or kidneys or any other organ for metabolism. And every time the function of those organs deteriorates or changes, you can see different response in whatever parameter you're following. Whereas the beauty about nafamostat, it really is not dependent on any organ.

所以這是一個非常、非常穩定的反應。這對我們而言並不算太意外，因為 nafamostat 的代謝其實不依賴任何特定器官。因此有些其他藥物的代謝會依賴肝臟、腎臟或其他器官。而每當這些器官的功能惡化或改變時，你就會在你追蹤的任何參數上看到不同的反應。相較之下，nafamostat 的優點在於它確實不依賴任何器官。

And most of these patients, they can have fluctuating organ function, which can affect other medications such as heparin being one example. Citrate is another example. If you have liver failure, citrate will not be metabolize as quickly. Nafamostat doesn't have those issues. So that's the reason why once you hit the target level, it essentially remains stable. Does that answer your question?

而這些病人大多可能會有器官功能波動，這會影響其他藥物，例如肝素就是一個例子。枸櫞酸鹽是另一個例子。如果有肝衰竭，枸櫞酸鹽就不會那麼快被代謝。nafamostat 沒有這些問題。所以這就是為什麼一旦達到目標水平，它基本上就會保持穩定。這有回答你的問題嗎？

Shakil, just a little bit more color. So on the administrative side, can you comment to the people on the line, how many of the sites are typically using citrate as a primary intervention for anticoagulation in CRRT and/or heparin as a primary intervention for anticoagulation in CRRT?

Shakil，再補充一點背景。在行政／執行層面，你能否向線上的各位說明一下，在 CRRT 的抗凝治療中，有多少研究中心通常是以枸櫞酸鹽作為主要介入手段，和／或以肝素作為主要介入手段？

Sure. So of the 12 sites that we have, we don't have any site that uses citrate as a standard of care. So there are two or three sites that will use citrate only if a patient continues to clot. And these sites do not use heparin at all. So the sites that are using citrate, they don't believe in heparin. So they, two or three sites that have access to citrate. They are not citrate-first users, only use citrate as a rescue as citrate is the only rescue they have.

當然。我們目前有 12 個研究中心，其中沒有任何一個中心把枸櫞酸鹽作為標準治療（standard of care）。有兩到三個中心只有在病人持續凝血（clot）時才會使用枸櫞酸鹽。而這些中心完全不使用肝素。所以使用枸櫞酸鹽的中心並不採用肝素。因此，只有兩到三個能取得枸櫞酸鹽的中心。他們不是「枸櫞酸鹽優先」的使用者，只把枸櫞酸鹽當作救援用藥，因為枸櫞酸鹽是他們唯一的救援選項。

We have two sites -- only one site that uses heparin as standard of care of all the sites that we have. Then we have two or three sites that use heparin as a rescue therapy. So they don't use either citrate or heparin when the CRRT started. But if they see clotting, they don't have access to citrate, so then they go back to rescue heparin. Majority of our sites right now, I would say, 10 out of 12 or 13 that we have, they don't really have any first-line anticoagulant that they use for every single patient. They are really using either heparin or citrate as a rescue. And we don't have any site that uses citrate for everybody.

我們有兩個中心——更正，只有一個中心在我們所有中心中把肝素作為標準治療。另外有兩到三個中心把肝素作為救援治療。也就是說，CRRT 開始時他們不使用枸櫞酸鹽或肝素。但如果看到凝血，而他們又無法取得枸櫞酸鹽，就會改用救援性肝素。目前我們大多數中心，我會說我們 12 或 13 個中心中有 10 個，並沒有一個對每位病人都使用的第一線抗凝劑。他們其實是把肝素或枸櫞酸鹽作為救援使用。而我們沒有任何中心對所有人都使用枸櫞酸鹽。

And I think importantly, Ed, when they execute the protocol in the NEPHRO study and the titration schedule, they see the ease of use, whether it's placebo or controlled doesn't matter, placebo or active doesn't matter. It's just the ease of that titration schedule compared to what their historic challenges have been with heparin and citrate and that seems to be the additional feedback. Simplicity is the main comment.

而且我認為很重要的一點是，Ed，當他們在 NEPHRO 研究中執行該方案與滴定時程時，他們會看到其易用性；不論是安慰劑或對照其實都無所謂，不論是安慰劑或主動治療也無所謂。重點是，相較於他們過去在肝素與枸櫞酸鹽上遇到的歷史性挑戰，這個滴定時程的操作更容易，而這似乎就是額外的回饋。「簡單」是主要評論。

Right. And the nurses, even we spoke visiting a site today and the nurses, they were like shocked, okay, we don't have to do anything else? No, that's it. That's all the monitoring that's required. Yes.

對。而且護理人員——我們今天去拜訪一個中心時，護理人員都很震驚，說：好，所以我們不用再做其他事了？不，就這樣。這就是所需的全部監測。是的。

There are no further questions at this time. I will now turn the call over to Vince. Please continue.

目前沒有進一步的問題。我現在把電話交給 Vince。請繼續。

Thank you, operator. And I'll just clarify my comment I said earlier about the site names, the additional two that will be coming on, that will be on clintrials.gov -- clinicaltrials.gov, excuse me, and our next update of those sites. So again, thank you all for joining us on our first-quarter earnings call. We're really very high on what's happening at the start of 2026 and the enrollment that's continuing to move forward. The NEPHRO study progress has been excellent.

謝謝，接線員。我也澄清一下我先前關於研究中心名稱的評論：接下來將加入的另外兩個中心，會公布在 clintrials.gov——更正，clinicaltrials.gov——以及我們下一次更新這些中心資訊時。再次感謝各位參加我們第一季財報電話會議。我們對 2026 年初的進展以及持續推進的收案非常有信心。NEPHRO 研究的進度一直非常出色。

Our commitment enthusiasm to bring the potentially new regional anticoagulant for CRRT to the market next year is unwavering. So we appreciate your attendance today, and we're very excited about the future for the NEPHRO study as well as Talphera moving forward. We'll provide you additional updates on our progress, and thank you for joining us on the call today. Operator, that concludes our call.

我們對於在明年將這項可能成為 CRRT 新的區域性抗凝劑推向市場的承諾與熱忱始終不變。因此感謝各位今天出席，我們也對 NEPHRO 研究以及 Talphera 後續的發展感到非常振奮。我們會就進展提供各位更多更新，並感謝各位今天參與本次電話會議。接線員，我們的會議到此結束。

Thank you very much. Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.

非常感謝。各位女士、先生，今天的電話會議到此結束。感謝各位的參與。您現在可以掛線。