Cidara Therapeutics Inc (CDTX) 2025 Q1 法說會逐字稿

Greetings. Welcome to Cidara's Q1 2025 earnings call. Please note, this conference is being recorded. (Operator Instructions) I will now turn the conference over to Brian Ritchie of LifeSci Advisors.

問候。歡迎參加 Cidara 2025 年第一季財報電話會議。請注意，本次會議正在錄製。（操作員指示）現在我將會議交給 LifeSci Advisors 的 Brian Ritchie。

Thank you. You may begin. Thank you, operator, and good afternoon, everyone. With me today on the phone from Cidara Therapeutics are Dr. Jeff Stein, President and Chief Executive Officer. Following Dr. Stein's prepared remarks, he will be joined by Mr. Frank Karbe, Chief Financial Officer; Dr. Nicole Davarpanah, Chief Medical Officer; Dr. Les Tari, Chief Scientific Officer; and Mr. Jim Beitel, Chief Business Officer, to participate in a Q&A session.

謝謝。你可以開始了。謝謝接線員，大家下午好。今天與我通電話的是 Cidara Therapeutics 公司總裁兼執行長 Jeff Stein 博士。在 Stein 博士發表準備好的演講之後，財務長 Frank Karbe 先生、首席醫療官 Nicole Davarpanah 博士、首席科學官 Les Tari 博士和首席商務官 Jim Beitel 先生將與 Stein 博士一起參加問答環節。

Earlier this afternoon, Cidara released financial results and a business update for the first quarter ended March 31, 2025. A copy of the press release and corporate presentation are available on the company's website. Please note that certain information discussed on the call today is covered under the Safe Harbor provision of the Private Securities Litigation Reform Act.

今天下午早些時候，Cidara 發布了截至 2025 年 3 月 31 日的第一季財務業績和業務更新。新聞稿和公司介紹的副本可在公司網站上查閱。請注意，今天電話會議上討論的某些資訊屬於《私人證券訴訟改革法案》安全港條款的涵蓋範圍。

We caution listeners that during this call, Cidara management will be making forward-looking statements. Actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the company's business. These forward-looking statements are qualified by the cautionary statements contained in Cidara's press release issued today and the company's SEC filings, including in the annual report on Form 10-K and subsequent filings.

我們提醒聽眾，在本次電話會議中，Cidara 管理階層將發表前瞻性陳述。由於公司業務相關的風險和不確定性，實際結果可能與這些前瞻性陳述所明示或暗示的結果有重大差異。這些前瞻性陳述受到 Cidara 今天發布的新聞稿和公司向美國證券交易委員會提交的文件（包括 10-K 表格年度報告和後續文件）中包含的警示性聲明的限制。

This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, May 8, 2025. Cidara undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call.

本次電話會議包含時間敏感訊息，僅截至本次直播之日（2025 年 5 月 8 日）準確。Cidara 不承擔修改或更新任何前瞻性陳述以反映本次電話會議日期之後的事件或情況的義務。

With that, I'd like to turn the call over to Jeff Stein. Jeff.

說完這些，我想把電話轉給傑夫‧史坦 (Jeff Stein)。傑夫。

Thanks, Brian, and thank you all for joining us for our first-quarter 2025 earnings call. Please note, given our upcoming virtual R&D Day on May 22, I'll keep my remarks brief today with the idea of sharing significantly more details around our ongoing CD388 clinical program at that event.

謝謝，布萊恩，也謝謝大家參加我們的 2025 年第一季財報電話會議。請注意，鑑於我們即將於 5 月 22 日舉行虛擬研發日，我今天的演講將簡短一些，目的是在該活動中分享有關我們正在進行的 CD388 臨床計劃的更多細節。

Moreover, given our current status as a non-revenue-generating company and in an effort to keep today's prepared remarks as succinct as possible, we will not have a dedicated section to review our quarterly financial results on this call. Rather, I will point you to the press release and our 10-Q, which were filed today. With that, and since this is our inaugural quarterly earnings call, let me begin by reminding everyone that Cidara's proprietary Cloudbreak platform enables the development of novel drug Fc conjugates or DFCs, a fundamentally new class of drug that combines the strength of small molecules with that of monoclonal antibodies.

此外，鑑於我們目前作為一家非創收公司的地位，並且為了使今天的準備發言盡可能簡潔，我們不會在本次電話會議上設立專門的部分來審查我們的季度財務業績。相反，我會向你指出我們今天提交的新聞稿和 10-Q。由於這是我們的首次季度收益電話會議，我首先要提醒大家，Cidara 專有的 Cloudbreak 平台能夠開發新型藥物 Fc 結合物或 DFC，這是一種全新的藥物類型，結合了小分子和單株抗體的優勢。

Our lead asset, CD388, we aim to revolutionize the prevention of influenza, which despite vaccines, has a mortality rate in the US that is similar to breast cancer, colorectal cancer and all blood cancers. CD388 combines a novel multivalent presentation of the approved antiviral small molecule drug, zanamivir, with a human antibody fragment to prolong half-life.

我們主要的資產 CD388 旨在徹底改變流感的預防方式，儘管有疫苗，但在美國，流感的死亡率與乳癌、大腸癌和所有血癌相似。CD388 將已核准的抗病毒小分子藥物扎那米韋的新型多價呈現與人類抗體片段相結合，以延長半衰期。

As an antiviral drug with universal activity against all flu strains, CD388 is not dependent on the host immune system for activity and is thereby designed to have universal activity in all people regardless of immune status. Its unique properties substantially enhance its antiviral activity, making it a potentially best-in-class neuraminidase inhibitor that overcomes the limitations of existing vaccines and antivirals.

CD388 是一種對所有流感病毒株均具有普遍活性的抗病毒藥物，其活性不依賴宿主免疫系統，因此旨在對所有人具有普遍活性，無論其免疫狀態如何。其獨特的特性大大增強了其抗病毒活性，使其成為潛在的最佳神經氨酸酶抑制劑，克服了現有疫苗和抗病毒藥物的限制。

Details of CD388's preclinical data were recently published in the journal Nature Microbiology. These data highlight the potential of CD388 as a potent universal antiviral for influenza A and B prophylaxis in healthy and high-risk populations regardless of immune status. This included activity against high pathogenicity strains like H5N1, also known as bird flu as well as strains that are resistant to approved neuraminidase inhibitors.

CD388 的臨床前數據詳情最近發表在《自然微生物學》雜誌上。這些數據凸顯了 CD388 作為一種強效通用抗病毒藥物的潛力，無論免疫狀態如何，它都可以用於健康和高風險族群的甲型和乙型流感預防。這包括針對高致病性株如 H5N1（也稱為禽流感）以及對已批准的神經氨酸酶抑制劑有抗藥性的病毒株的活性。

In April of last year, Cidara presented data at the 34th ESCMID conference from our Phase I single ascending dose study of CD388, which showed it to be well tolerated and with an extended half-life, supporting the potential of once per flu season dosing. We also presented data at this conference from our Phase IIa human challenge study of CD388 in healthy volunteers.

去年 4 月，Cidara 在第 34 屆 ESCMID 會議上展示了我們 CD388 I 期單次遞增劑量研究的數據，該研究表明該藥物耐受性良好且半衰期較長，支持在每個流感季節進行一次給藥的潛力。我們也在本次會議上展示了在健康志願者中進行的 CD388 IIa 期人體挑戰研究的數據。

The results showed that a single 150-milligram subcutaneous dose of CD388 provided substantial protective efficacy compared to placebo and supported the advancement of CD388 to a Phase IIb study. This 150-milligram dose is the lowest of 3 doses tested in our Phase IIb study. Our NAVIGATE Phase IIb study evaluating the efficacy and safety of a single administration of CD388 for the prevention of seasonal influenza in healthy adult subjects was initiated the last week of September of last year. Dosing of 5,041 subjects was completed in the first week of December. Subjects were randomized across 3 CD388 dose groups, 150 milligrams, 300 milligrams or 450 milligrams and 1 placebo group.

結果顯示，單次150毫克皮下注射CD388與安慰劑相比具有顯著的保護作用，並支持CD388推進至IIb期研究。150 毫克的劑量是我們在 IIb 期研究中測試的 3 種劑量中最低的劑量。我們的 NAVIGATE IIb 期研究於去年 9 月的最後一周啟動，旨在評估單次使用 CD388 對健康成年受試者預防季節性流感的有效性和安全性。12 月第一週完成了 5,041 名受試者的給藥。受試者被隨機分配到 3 個 CD388 劑量組，150 毫克、300 毫克或 450 毫克，以及 1 個安慰劑組。

The primary analysis will include all available data as of April 30, 2025, and we expect to announce top line data by the end of June. The NAVIGATE study was initially designed primarily to determine dose selection for Phase III and was not powered for statistical significance. However, as a result of the severity of the 2024, 2025 flu season, we are discussing potential changes to the study's statistical analysis plan with the FDA to evaluate possible statistical significance of CD388 versus placebo. Dependent on the results of our Phase IIb study and our regulatory discussions, we expect to initiate a Phase III study in the spring of 2026 in the Southern Hemisphere. We plan to conduct our Phase III study in high-risk comorbid and immune-compromised patients.

主要分析將包括截至 2025 年 4 月 30 日的所有可用數據，我們預計將在 6 月底公佈頂線數據。NAVIGATE 研究最初主要是為了確定 III 期的劑量選擇而設計的，並不具備統計意義。然而，由於 2024 年、2025 年流感季節的嚴重性，我們正在與 FDA 討論研究的統計分析計劃進行潛在更改，以評估 CD388 與安慰劑相比的可能統計意義。根據我們 IIb 期研究的結果和監管討論，我們預計將於 2026 年春季在南半球啟動 III 期研究。我們計劃對高風險合併症和免疫功能低下的患者進行第三階段研究。

We are focusing our efforts initially in these populations because they are disproportionately affected by influenza as evidenced by substantially higher rates of hospitalizations and deaths and are underserved by currently available vaccines or antiviral drugs. On May 22, we plan to host an R&D Day. The event will focus on a review of the 2024-2025 flu season, updates on our ongoing Phase IIb NAVIGATE trial, updates on our regulatory discussions and our plans for a Phase III study as well as insights into the unmet needs of influenza and the potential commercial opportunity for CD388. In closing, the data we have generated to date further validate our Cloudbreak DSC platform and the potential of CD388 to offer universal protection against both seasonal and pandemic influenza strains. While vaccines play a vital role in flu prevention, they do not offer sufficient protection, particularly for immune-compromised individuals, underscoring the critical need for a durable, broadly acting antiviral like CD388.

我們最初將精力集中在這些人群身上，因為他們受到流感的影響尤其嚴重，住院率和死亡率明顯較高，目前可用的疫苗或抗病毒藥物不足以滿足他們的需求。5 月 22 日，我們計劃舉辦研發日。活動將重點回顧 2024-2025 年流感季節、我們正在進行的 IIb 期 NAVIGATE 試驗的最新情況、我們的監管討論的最新情況和我們的 III 期研究計劃，以及對流感未滿足需求和 CD388 潛在商業機會的見解。最後，我們迄今為止產生的數據進一步驗證了我們的 Cloudbreak DSC 平台和 CD388 提供對季節性和大流行性流感病毒株的普遍保護的潛力。雖然疫苗在預防流感方面發揮著至關重要的作用，但它們並不能提供足夠的保護，特別是對於免疫力低下的人群，這凸顯了對像 CD388 這樣持久、廣泛作用的抗病毒藥物的迫切需求。

We look forward to the results of our Phase IIb clinical trial, continued discussions with the FDA and the potential initiation of our planned Phase III study. With that, I will turn it back to the operator to take your questions.

我們期待 IIb 期臨床試驗的結果、與 FDA 的繼續討論以及我們計劃的 III 期研究的潛在啟動。說完這些，我會把話題轉回給接線生來回答你們的問題。

(Operator Instructions) Eric Schmidt, Cantor.

（操作員指示）埃里克·施密特，領唱。

Honored to be the inaugural question on your inaugural earnings conference call. Jeff, it was a little unclear to me from your statements whether you've had your discussions with the FDA regarding the statistical for the Phase IIb or whether those discussions are still ongoing.

很榮幸成為您首次收益電話會議的首個提問者。傑夫，從你的陳述中我不太清楚你是否已經與 FDA 討論過 IIb 期的統計數據，或者這些討論是否仍在進行中。

Yes, Eric, we have had those discussions, and we look forward to sharing the statistical analysis plan update at our May 22 R&D Day event.

是的，艾瑞克，我們已經進行了這些討論，我們期待在 5 月 22 日的研發日活動中分享統計分析計畫更新。

And maybe as a follow-up, have you had time to better fine-tune or hone in on your definition of what a high-risk patient population might actually mean or be defined by in terms of demographics in the Phase III?

作為後續問題，您是否有時間更好地調整或完善您對高風險患者群體的實際含義或根據第三階段的人口統計特徵進行定義的定義？

Yes. We also plan to share that at the R&D Day event. So we are finalizing the assessment of those populations, and we're really looking forward to highlighting that in the commercial section of R&D Day event.

是的。我們也計劃在研發日活動上分享這一點。因此，我們正在最終確定對這些人群的評估，我們非常期待在研發日活動的商業部分強調這一點。

Seamus Fernandez, Guggenheim.

謝默斯·費爾南德斯，古根漢美術館。

Jeff, congratulations on keeping your presentation almost as brief as the open harbor statement. So I'll just go with a quick question here. I think to Eric's question around the size of the patient population, I know you guys are going to address a little bit more in the context of the R&D Day in terms of the size of the potential patient population to consider here. But historically, I think you've talked about 20 million patients. Just wondering if you see a broader opportunity than that.

傑夫，恭喜你的演講幾乎和開放港聲明一樣簡短。所以我只想在這裡問一個簡單的問題。我認為對於 Eric 關於患者群體規模的問題，我知道你們將在研發日的背景下就需要考慮的潛在患者群體規模進行更多討論。但從歷史上看，我認為您談到了 2000 萬名患者。只是想知道您是否看到了比這更廣泛的機會。

And then just my follow-up question to that is in terms of a pricing dynamic, historically, we've modeled something in the range of $180 to $200. But I think in other conversations that we've had, a range potentially broader than that has been discussed. So just love to get a little bit more color for those participating in the call to give a little bit of a preview for the R&D Day.

然後我的後續問題是，就定價動態而言，從歷史上看，我們模擬的價格範圍在 180 美元到 200 美元之間。但我認為，在我們進行的其他對話中，討論的範圍可能比這更廣泛。因此，我很樂意為參加電話會議的人們提供更多細節，以便對研發日進行一些預覽。

Yes. Sure, Seamus. And I'll give you a few remarks, then I'll turn it over to Jim Beitel to refine those remarks. And again, we will share more details at the R&D Day event. But yes, our thinking has evolved since we last spoke about this, and we see a substantial opportunity in that high-risk comorbid as well as the immune compromised populations.

是的。當然，謝默斯。我會向你們提出幾點意見，然後我會把發言權交給 Jim Beitel 來完善這些意見。再次，我們將在研發日活動上分享更多細節。但是，是的，自從我們上次談論這個問題以來，我們的想法已經發生了變化，我們在高風險合併症以及免疫功能低下的人群中看到了巨大的機會。

And so let me turn it over to Jim, and I'll let him give you an update on some of those broad parameters with the aim of providing more details on both the size of the population as well as pricing. Jim?

因此，讓我將主題交給吉姆，讓他向您介紹一些廣泛的參數，目的是提供有關人口規模和定價的更多詳細資訊。吉姆？

Yes. Certainly, Jeff. Thanks for the question, Seamus, and it's certainly a good one. We've been thinking more deeply about the patient segmentation quite a bit these days. And the 20 million number refers to people with very severe forms of COPD, heart disease, renal disease and more severe forms of immune compromised status.

是的。當然，傑夫。謝謝你的提問，Seamus，這確實是一個很好的問題。這些天，我們對患者細分進行了更深入的思考。2000 萬這個數字指的是患有非常嚴重的慢性阻塞性肺病、心臟病、腎臟病以及更嚴重的免疫功能低下的人。

We definitely see upside beyond that. It's very clear in our market research that physicians have broader interest in the product. And so we are interested in people with moderate forms of these conditions. And I think you'll see some of that segmentation data in our current corporate deck that's available on the website, and we'll get into it in more detail in the 22nd along with the market research findings from our physician and payer interviews. I think you also asked a question about price, and we'll also get into this in more detail on the 22nd.

我們肯定看到了超越這一水準的優勢。我們的市場調查清楚地表明，醫生對該產品有更廣泛的興趣。因此，我們對患有中度此類疾病的人很感興趣。我想您會在我們網站上提供的當前公司資料中看到一些細分數據，我們將在 22 日更詳細地介紹這些數據，同時還會介紹我們對醫生和付款人進行訪談的市場研究結果。我想您也問了有關價格的問題，我們也將在 22 日更詳細地討論這個問題。

But we certainly see opportunity for pricing meaningfully above the number that you mentioned there. This is not a vaccine, and it's also a product that has the potential by focusing on these higher-risk comorbidities to bring substantial value, and we're seeing that sort of be reflected in the market research we're doing. So excited to get into that more on the 22nd, but very confident in price points above the number that you mentioned there.

但我們確實看到了將價格大幅高於您提到的數字的機會。這不是疫苗，它也是一種透過關注這些高風險合併症而有可能帶來巨大價值的產品，我們看到這一點反映在我們正在進行的市場研究中。我很高興能在 22 日進一步了解這一情況，但對於您提到的價格點非常有信心。

Gregory Renza, RBC Capital Markets.

加拿大皇家銀行資本市場 (RBC Capital Markets) 的 Gregory Renza。

Congrats on the progress so far. We're all looking forward to the updates in the next couple of months. Jeff, maybe I'll just start with just a broader one. Just with respect to your positioning of CD388, amidst a great deal of dialogue amongst the community, both publicly and amongst regulatory bodies about vaccines and evolving views on that. How should we think about CD388 and that positioning?

祝賀迄今為止的進展。我們都期待著未來幾個月的更新。傑夫，也許我應該從更廣泛的角度開始。就您對 CD388 的定位而言，在社區內部、公眾和監管機構就疫苗及其不斷變化的觀點進行了大量對話的情況下。我們該如何看待CD388和那個定位？

Of course, you mention of the single seasonal dose of prophylaxis amidst the broad but also high-risk populations as well as potential complementarity with vaccines. Curious on your broader thoughts there.

當然，您提到了在廣泛但高風險族群中進行單次季節性預防劑量以及與疫苗的潛在互補性。好奇您更廣泛的想法。

Yes, great questions. We do aim to initially develop CD388 in that high-risk population. So definite focus are in those populations that are underserved by vaccines. And even in healthy normal individuals, roughly about 40% of people get vaccinated. And of those, it's about 40% effective.

是的，很好的問題。我們確實計劃首先在高危險群中開發 CD388。因此，重點肯定是那些疫苗接種不足的人。即使是健康的正常人，也有大約 40% 的人接種疫苗。其中，其有效性約為 40%。

So certainly, there's an opportunity to expand beyond that high-risk population, and that has definitely captured our attention, and that's a plan for future development. We are also in discussions with BARDA for the opportunity to collaborate with BARDA given CD388's potential for the prevention of H5N1. So we see a number of opportunities in both high risk as well as in broader populations that CD388 can definitely benefit. And Jim, anything else you'd like to add to Greg's question?

因此，當然有機會將服務範圍擴大到高風險族群之外，這無疑引起了我們的注意，這也是未來發展的計畫。鑑於 CD388 在預防 H5N1 方面的潛力，我們也正在與 BARDA 討論合作的機會。因此，我們看到 CD388 無論是在高風險族群或更廣泛的人群中都存在著一定的好處。吉姆，您還有什麼要補充回答格雷格的問題嗎？

No, Jeff, I think you said it very well. I feel really confident that physicians are recognizing that vaccines are not adequately protecting these individuals. And if they were, I think we'd see something different in the hospitalization rate data.

不，傑夫，我認為你說得很好。我確信醫生們已經認識到疫苗不足以保護這些人。如果是這樣，我認為我們會在住院率數據中看到一些不同的東西。

So unmet need despite vaccination is clearly there. And actually, we'll have some data on this on the 22nd, where we ask physicians, the specialists, in particular, those that manage these high-risk patients, their perception of the importance of flu and preventing flu in these patients. And it's very strong data, and I'll be excited to share that with you on the 22nd.

因此，儘管接種了疫苗，但顯然仍存在未滿足的需求。實際上，我們將在 22 日獲得一些這方面的數據，屆時我們會詢問醫生、專家，特別是那些管理這些高風險患者的醫生，了解他們對流感重要性的看法以及對這些患者預防流感的方法。這是非常有力的數據，我很高興在 22 日與大家分享。

And Greg, just to get to the last part of your question, we do aim to develop CD388 in conjunction with existing vaccines. I think you may have been referring to the fact that CD388 in general targets a different target than vaccines. So vaccines target hemoglobin and CD388 targets neuraminidase. We see that there is a potential that there could be some complementarity on top of vaccines. We haven't demonstrated that yet, but we hope to be able to do that in the clinic.

格雷格，回到你問題的最後一部分，我們的目標是結合現有疫苗開發 CD388。我認為您可能指的是 CD388 的目標通常與疫苗的目標不同。因此疫苗針對的是血紅素，而 CD388 針對的是神經氨酸酶。我們發現疫苗之間有一定的互補性。我們還沒有證明這一點，但我們希望能夠在臨床上做到這一點。

That's great. Really appreciate that. And maybe just as my follow-up, and we can brace ourselves for the details, but I just wanted to ask you to potentially just frame up the primary endpoint for NAVIGATE and just that the composite and the mechanics of the data collection around PCR, and of course, the symptom collection and the visits. Any additional color that you could add about how that comes about would be greatly appreciated. Lots of investors --

那太棒了。真的很感激。也許只是作為我的後續行動，我們可以為細節做好準備，但我只是想請您盡可能地構建 NAVIGATE 的主要終點，以及圍繞 PCR 的數據收集的綜合和機制，當然還有症狀收集和訪問。如果您能補充關於此事如何發生的額外信息，我們將不勝感激。很多投資者--

Absolutely. And Nicole is in the best position to address that question on how we evaluate the primary endpoint in the NAVIGATE study. Nicole?

絕對地。妮可最適合回答我們如何評估 NAVIGATE 研究的主要終點這個問題。妮可？

Greg, thanks for the question. So our primary endpoint is preventive efficacy, and that is evaluated by centrally confirmed influenza infection, which has three key components. So the first one would be nasopharyngeal PCR positivity. And so when subjects come in with symptoms, they are evaluated for a local mid-turbinate swab as well as in nasopharyngeal swab, which is a little bit more invasive swab, and that is sent to a central lab for confirmation. That is the first piece.

格雷格，謝謝你的提問。因此，我們的主要終點是預防效果，並透過集中確認的流感感染來評估，它包含三個關鍵組成部分。因此第一個是鼻咽 PCR 陽性。因此，當受試者出現症狀時，會接受局部中鼻甲拭子以及鼻咽拭子（侵入性更強的拭子）的評估，然後送往中央實驗室進行確認。這是第一部分。

In addition, there are requirements for a body temperature of 38 degrees as well as two symptoms, respiratory or one respiratory and one systemic. So as you can see, it's a robust evaluation to really confirm symptomatic and severe flu.

此外，還要求體溫達到 38 度，並且有兩個症狀，即呼吸道症狀或一項呼吸道症狀和一項全身症狀。因此，正如您所看到的，這是一個強有力的評估，可以真正確認有症狀的流感和嚴重的流感。

Joseph Stringer, Needham & Company.

約瑟夫·斯特林格，Needham & Company。

Just on the Phase IIb readout for the three dose levels, are you anticipating that we would see a dose-dependent response on efficacy? And I suppose has that view changed given the higher-than-expected breakthrough infection rates here? And maybe lastly, how important is it that seeing a dose response from a data confidence standpoint and potential next steps?

僅從 IIb 期三個劑量等級的讀數來看，您是否預期我們會看到對療效的劑量依賴性反應？我想，鑑於這裡的突破性感染率高於預期，這種觀點是否改變了？最後，從數據信心的角度和潛在的後續步驟來看劑量反應有多重要？

Yes, that's an important question, Joey. And keep in mind that the subjects were enrolled from the last week of September to the first week of December. And so there's going to be a gradation of exposures over time. And so yes, we do expect to see a dose dependence, but probably more succinctly, we expect to see an exposure dependence because one can envision that subjects randomized in the high-dose group dosed first end of September might have lower exposure towards the end of the study than subjects dosed last in the study at the lower dose.

是的，這是一個重要的問題，喬伊。請記住，受試者是從九月的最後一周到十二月的第一周入學的。因此，隨著時間的推移，曝光程度會逐漸增加。所以是的，我們確實希望看到劑量依賴性，但可能更簡潔地說，我們希望看到暴露依賴性，因為可以設想，9 月底首次接受給藥的高劑量組隨機受試者在研究結束時的暴露量可能低於研究中最後接受較低劑量給藥的受試者。

So yes, we do expect to see a dose dependence because it is randomized. However, it's more important that we actually look at the relationship between exposure and efficacy, and we hope to be able to talk about that when we disclose top line data as well.

所以是的，我們確實希望看到劑量依賴性，因為它是隨機的。然而，更重要的是我們實際上要研究暴露和功效之間的關係，我們希望在揭露頂線資料時也能夠談論這一點。

(Operator Instructions) Roy Buchanan, Citizens Bank.

（操作員指示）羅伊·布坎南，公民銀行。

Just, I guess, a follow-up on the last one. Are you going to be able to present any, I guess, time course data, Kaplan-Meier curve kind of data for each of the doses? Are we going to be able to see when patients actually had an event going through the trial?

我想，這只是上一個問題的後續。我想，您能否提供每種劑量的時間過程資料、Kaplan-Meier 曲線類型的資料？我們是否能夠看到患者在試驗過程中實際發生的情況？

I'm not sure we will have that high resolution of information in the top line results. But let me turn that to Nicole to see if she's more familiar with the level of detail that we'll have in those top line tables, listings and figures.

我不確定我們是否會在頂線結果中獲得如此高解析度的資訊。但是，讓我把這個問題轉給妮可，看看她是否更熟悉我們在那些頂線表格、清單和數字中所擁有的詳細程度。

Thanks for the question. We are expecting to have essentially kind of prevention efficacy data as numerical tables at this time. The reason being that we do want to continue to follow the PK data that comes in throughout the trial. And as you know, this is not a time-to-event analysis. It's when a kind of subject develops a binary flu. So we don't expect to have Kaplan-Meier differentiation.

謝謝你的提問。我們期望此時能夠獲得以數值表形式呈現的預防功效數據。原因是我們確實希望繼續追蹤整個試驗過程中獲得的 PK 數據。如您所知，這不是事件發生時間的分析。這是當一種主體發展出二元流感時的情況。所以我們不希望有 Kaplan-Meier 分化。

Okay. Got it. And I guess as a follow-up to that, and I have a follow-up, but when do you think we might see that PK data?

好的。知道了。我想作為對此的後續行動，我有一個後續行動，但您認為我們什麼時候可以看到 PK 數據？

We expect the PK data at the end of the trial. So that would be approximately a September analysis. We are certainly going to try to obtain it, however. And so we may be able to see some of that data. But because we had essentially had an April 30 data cut, there will be further PK data that comes in that might be substantially important. And so if it's not definitive, we plan to wait until that September deadline.

我們期待試驗結束時的 PK 數據。這大概就是九月的分析。然而，我們一定會努力去獲得它。因此我們也許能夠看到其中的一些數據。但由於我們基本上已經在 4 月 30 日截取了數據，因此將會有更多可能非常重要的 PK 數據進入。因此，如果尚未確定，我們計劃等到 9 月的最後期限。

As a follow-up to that, Roy, as you know, the CD388 does have a long half-life of 6 to 8 weeks. And for safety, we will be following subjects out for 5 half-lives. And so the final data we expect in September now. We don't expect to have any substantial number of new flu infections occurring after April 30. So it's not for efficacy, but it's more for PK and safety.

作為後續問題，Roy，如您所知，CD388 的半衰期確實很長，為 6 至 8 週。為了安全起見，我們將追蹤受試者 5 個半衰期。因此，我們現在預計最終數據將在九月公佈。我們預計 4 月 30 日之後不會出現大量新的流感感染病例。所以不是為了功效，更多的是為了PK和安全性。

Yes. Yes, even is pretty much done, right? And then sorry, let me ask one more because I suspect on the last question and kind of along the same lines, if I'm counting right, it looks like the data cutoff is about three weeks before the 24-week potential limit. I mean, was that really based on the flu season rates or the rates observed in the study?

是的。是的，甚至差不多完成了，對吧？然後抱歉，讓我再問一個，因為我懷疑最後一個問題與此類似，如果我沒算錯的話，數據截止時間似乎比 24 週的潛在限制早三週左右。我的意思是，這真的是基於流感季節的發生率還是研究中觀察到的發生率？

It was based on the diminishing returns, right? So the CDC definition for the flu season coincides with April 30. We saw a decrease in the pace of infections appearing in the study that coincided with that date.

這是基於收益遞減的，對嗎？因此，CDC 對流感季節的定義與 4 月 30 日一致。我們在與該日期相吻合的研究中發現感染速度有所下降。

There are no further questions at this time. I will turn the call over to Jeff Stein for closing remarks.

目前沒有其他問題。我將把電話轉給傑夫·斯坦 (Jeff Stein) 作結束語。

Well, thank you all for joining us today. We greatly appreciate your interest in Cidara and hope that you can join us for our R&D Day on May 22. Enjoy your evening.

好吧，感謝大家今天加入我們。我們非常感謝您對 Cidara 的關注，並希望您能參加我們 5 月 22 日的研發日。祝您晚上愉快。

Ladies and gentlemen, this concludes your conference call for today. We thank you for participating and ask that you please disconnect your lines.

女士們、先生們，今天的電話會議到此結束。感謝您的參與，並請您斷開線路。