Cidara Therapeutics Inc (CDTX) 2025 Q2 法說會逐字稿

Good afternoon, and welcome to the Cidara Therapeutics second-quarter 2025 earnings conference call. (Operator Instructions). Please note that the event is being recorded. I would now like to turn the conference over to Brian Ritchie with LifeSci Advisors. Please go ahead.

下午好，歡迎參加 Cidara Therapeutics 2025 年第二季財報電話會議。（操作員指令）。請注意，該事件正在被記錄。現在，我想將會議交給 LifeSci Advisors 的 Brian Ritchie。請繼續。

Thank you, operator, and good afternoon, everyone. With me today on the phone from Cidara Therapeutics is 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 second quarter ended June 30, 2025. A copy of the press release and the company's corporate presentation are available on its company 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 6 月 30 日的第二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.

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。

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. This conference call also contains time-sensitive information that is accurate only as of the date of this live broadcast, August 7, 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.

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。本次電話會議也包含時間敏感訊息，這些資訊僅在本次直播之日（2025 年 8 月 7 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 Dr. Jeff Stein. Jeff?

說到這裡，我想把電話轉給傑夫史坦博士。傑夫？

Thank you, Brian, and thank you all for joining us for our second quarter 2025 earnings call. We made substantial progress in the second quarter, most notably with the announcement of positive top line results from our Phase IIb NAVIGATE clinical trial, our subsequent $400 million financing and advancing our discussions with the FDA and BARDA regarding the further development of CD388.

謝謝你，布萊恩，也謝謝大家參加我們的 2025 年第二季財報電話會議。我們在第二季度取得了實質進展，最引人注目的是宣布了 IIb 期 NAVIGATE 臨床試驗的積極頂線結果、隨後獲得了 4 億美元的融資，並推進了與 FDA 和 BARDA 就 CD388 進一步開發的討論。

In an effort to keep today's prepared remarks as succinct as possible and given our current status as a non-revenue generating company, we will not have a dedicated section to review our quarterly financial results on this call and will not repeat in detail information that which has been previously discussed. Rather, I will point you to the press release and 10-Q we filed earlier today.

為了使今天的準備好的發言盡可能簡潔，並且考慮到我們目前作為一家非創收公司的地位，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，也不會詳細重複之前已經討論過的信息。相反，我會向你指出我們今天早些時候提交的新聞稿和 10-Q。

With that, I will 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 drugs that combines the strengths of small molecules with those of monoclonal antibodies.

首先我想提醒大家的是，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, is a once-per-flu season antiviral drug with universal activity against all flu strains and is designed to have universal activity in all people regardless of immune status. Its unique properties substantially enhance its antiviral activity, making it a potentially transformational universal preventative of influenza that overcomes the limitations of existing vaccines and antivirals.

我們的主要資產 CD388 是一種每流感季節使用一次的抗病毒藥物，具有針對所有流感病毒株的普遍活性，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，使其成為一種具有變革性的通用流感預防措施，克服了現有疫苗和抗病毒藥物的限制。

In late June, we announced the top line results from our NAVIGATE Phase IIb study, which evaluated the efficacy and safety of a single administration of CD388 for the prevention of seasonal influenza in healthy adult subjects. The study was initiated the last week of September of last year, and enrollment was completed with over 5,000 subjects in the first week of December 2024 before the peak of the flu season. Subjects were randomized across three CD388 dose groups and one placebo group.

6 月下旬，我們公佈了 NAVIGATE IIb 期研究的最終結果，該研究評估了單次使用 CD388 對健康成年受試者預防季節性流感的有效性和安全性。該研究於去年 9 月的最後一周啟動，並於 2024 年 12 月流感季節高峰之前的第一周完成了超過 5,000 名受試者的招募。受試者被隨機分配到三個 CD388 劑量組和一個安慰劑組。

The primary analysis included all available data as of April 30, 2025. The NAVIGATE study was designed initially to determine dose selection for the Phase III study and was not powered for statistical significance. Prior to study start, we had expected based on historical flu season averages, that 2% of participants in the placebo arm would develop influenza illness.

主要分析包括截至 2025 年 4 月 30 日的所有可用數據。NAVIGATE 研究最初旨在確定 III 期研究的劑量選擇，並不具備統計學意義。在研究開始之前，我們根據歷史流感季節的平均值預計，安慰劑組的 2% 參與者會患上流感疾病。

However, as the 2024-2025 flu season unfolded, we updated this forecast and predicted that the placebo attack rate could be sufficiently high for the NAVIGATE study to be powered for statistical significance. Based on this updated forecast, we discussed and reached agreement with the FDA on modifications to the study's statistical analysis plan to evaluate the potential statistical significance of CD388 efficacy versus placebo.

然而，隨著 2024-2025 年流感季節的展開，我們更新了這項預測，並預測安慰劑發病率可能足夠高，以使 NAVIGATE 研究具有統計意義。根據這項更新的預測，我們與 FDA 討論並達成一致，修改了研究的統計分析計劃，以評估 CD388 療效與安慰劑相比的潛在統計意義。

The observed placebo attack rate in the NAVIGATE study was 2.8%, which enabled the detection of a statistically significant difference from placebo at each dose group. Single doses of 450 milligrams, 300 milligrams and 150 milligrams of CD388 confirm 76%, 61% and 58% protection, respectively, with p-values of less than 0.0001, 0.0024 and 0.005 at each dose, respectively. This is remarkable given the relatively small size of the study compared to vaccine studies.

NAVIGATE 研究中觀察到的安慰劑發作率為 2.8%，這使得我們能夠檢測到每個劑量組與安慰劑之間的統計學上顯著差異。單劑量 450 毫克、300 毫克和 150 毫克 CD388 分別可確認 76%、61% 和 58% 的保護率，每劑的 p 值分別小於 0.0001、0.0024 和 0.005。與疫苗研究相比，該研究的規模相對較小，因此這一結果非常引人注目。

Importantly, the prevention efficacy data for each of the CD388 dose groups exceeded the historical average vaccine effectiveness of approximately 40% for a seasonal vaccine. The safety and tolerability data were consistent with prior studies of CD388 and similar in all arms of the study with no safety signals observed. While we observed a clear dose response relationship for efficacy, there were no meaningful changes in safety across the dose groups and placebo.

重要的是，每個 CD388 劑量組的預防效果數據都超過了季節性疫苗的歷史平均疫苗有效性（約 40%）。安全性和耐受性數據與 CD388 的先前研究一致，且在研究的所有部分中都相似，未觀察到安全訊號。雖然我們觀察到療效有明顯的劑量反應關係，但劑量組和安慰劑之間的安全性並沒有顯著變化。

These and additional details of the full NAVIGATE top line results, including a replay of the data call, are available on our website under the Investors tab. We plan to present additional details from the NAVIGATE trial at upcoming scientific conferences later this year. We believe that these results are groundbreaking for the field of influenza and support our confidence in the potential of CD388 to offer robust once-per-season protection against influenza A and B.

這些以及完整的 NAVIGATE 頂線結果的更多詳細資訊（包括資料呼叫的重播）可在我們網站的「投資者」標籤下找到。我們計劃在今年稍後舉行的科學會議上展示 NAVIGATE 試驗的更多細節。我們相信這些結果對於流感領域具有開創性意義，並增強了我們對 CD388 提供針對甲型和乙型流感的強效每季一次保護的潛力的信心。

Based on these robust data, we submitted our end of Phase II meeting request to the FDA to review the data and discuss the details of a Phase III study. This meeting has been scheduled for later this month. Once we have received the meeting minutes from the FDA, we plan to disclose key details of our planned Phase III study, including study design, dose selection and time lines. We have guided previously to initiate this study in the Southern Hemisphere in the spring of 2026.

基於這些可靠的數據，我們向 FDA 提交了第二階段會議結束請求，以審查數據並討論第三階段研究的細節。該會議計劃於本月稍後舉行。一旦我們收到 FDA 的會議記錄，我們計劃披露我們計劃的 III 期研究的關鍵細節，包括研究設計、劑量選擇和時間表。我們之前曾指導於2026年春季在南半球啟動這項研究。

Pending feedback from the FDA, we are confident that we can meet that goal, but we are also operationally prepared to start the study this fall should this become an option based on the outcome of our end of Phase II meeting. If we are able to start Phase III this fall, we believe that the study will enroll over the course of two flu seasons, the 2025, 2026 Northern Hemisphere and the subsequent 2026 Southern Hemisphere flu season.

在等待 FDA 的回饋意見時，我們有信心能夠實現這一目標，但如果根據我們第二階段會議結束的結果，這成為一種選擇，我們也做好了在今年秋天開始研究的準備。如果我們能夠在今年秋天啟動第三階段，我們相信這項研究將在兩個流感季節，即 2025 年、2026 年北半球流感季節以及隨後的 2026 年南半球流感季節中招募受試者。

Following the initial flu season, we plan to conduct an interim analysis for potential trial resizing. In Phase III, we plan to focus our efforts initially on large populations with the highest unmet need, which includes high-risk comorbid and immune-compromised patients because they are disproportionately affected by influenza as evidenced by substantially higher rates of hospitalizations and deaths and are underserved by currently available vaccines and antiviral drugs.

在第一個流感季節過後，我們計劃對潛在的試驗規模調整進行中期分析。在第三階段，我們計劃首先將精力集中在未滿足需求最高的大量人群上，其中包括高風險合併症患者和免疫功能低下的患者，因為他們受到流感的影響尤為嚴重，住院率和死亡率明顯較高，而且目前可用的疫苗和抗病毒藥物無法滿足他們的需要。

Our plan to address these high unmet need populations is the basis for CD388's current Fast Track and Priority Review designations. In addition, based on the strength of the Phase IIb results, we have submitted to the FDA an application for breakthrough therapy designation and expect to hear the outcome of this application later this year.

我們針對這些未滿足需求人群的計劃是 CD388 當前快速通道和優先審查指定的基礎。此外，基於 IIb 期研究結果的優勢，我們已向 FDA 提交了突破性療法認定申請，預計將於今年稍後聽到該申請的結果。

I would also add that we have submitted a proposal to BARDA, which, if funded, could provide meaningful funding to support manufacturing and additional clinical development studies of CD388. We expect to learn the outcome of this submission also by the end of this year. As we prepare to advance CD388 into Phase III, we do so from a position of significant financial strength, having recently closed an upsized public offering for gross proceeds of $402.5 million, which provides funding through the completion of our planned Phase III study.

我還要補充一點，我們已經向 BARDA 提交了一份提案，如果獲得資助，該提案可以提供有意義的資金來支持 CD388 的製造和額外的臨床開發研究。我們預計在今年底前就能知道提交的結果。當我們準備將 CD388 推進到第三階段時，我們擁有雄厚的財務實力，最近我們完成了一項擴大規模的公開發行，總收益為 4.025 億美元，這為我們完成計劃中的第三階段研究提供了資金。

This funding also enables us to conduct additional supportive clinical and nonclinical studies as well as additional market research to further characterize the cost effectiveness and commercial opportunities for CD388, both in the US and ex US This includes work to highlight the burden of illness that influenza represents in our initial target population and the cost offsets that could potentially be achieved with CD388.

這筆資金還使我們能夠進行額外的支持性臨床和非臨床研究以及額外的市場研究，以進一步確定 CD388 在美國和美國以外的成本效益和商業機會，其中包括強調流感在我們最初的目標人群中所帶來的疾病負擔以及 CD388 可能實現的成本補償。

We plan to present the results of these activities in the coming months following the conclusion of our discussions with the FDA regarding our Phase III plans. In closing, the data we have generated to date further validate our Cloudbreak DFC platform and the potential of CD388 to offer universal protection against both seasonal and pandemic influenza strains.

我們計劃在與 FDA 就我們的第三階段計劃進行討論後，在未來幾個月內公佈這些活動的結果。最後，我們迄今為止產生的數據進一步驗證了我們的 Cloudbreak DFC 平台和 CD388 提供季節性和大流行性流感病毒株的普遍保護的潛力。

While vaccines play a vital role in flu prevention, they do not offer sufficient protection, particularly for immune-compromised individuals, underscoring the need for a durable, broadly acting antiviral like CD388. We look forward to discussing our planned Phase III study design and trial start time frame with the FDA shortly.

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需求。我們期待很快與 FDA 討論我們計劃的 III 期研究設計和試驗開始時間框架。

With that, I will turn it back to the operator to take your questions.

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)

（操作員指示）

Seamus Fernandez, Guggenheim Securities.

古根漢證券公司的謝默斯·費爾南德斯。

Great, thanks so much for the question. So just wanted to see if you can help us understand potential differences from the Type C meeting that you had with FDA and the planned Phase III design that you shared with us during your Analyst Day, if there are any potential changes or meaningful changes that you're proposing or if you're simply looking for your sort of pre-Phase III discussion to just clarify those particular points from the Type C meeting.

太好了，非常感謝您的提問。所以只是想看看您是否可以幫助我們了解您與 FDA 舉行的 C 類會議與您在分析師日期間與我們分享的計劃中的 III 期設計之間的潛在差異，是否有任何您建議的潛在變化或有意義的變化，或者您是否只是希望通過 III 期前的討論來澄清 C 類會議中的那些特定觀點。

And then just as a follow-up question on BARDA, I was hoping to get a better understanding of exactly what you would hope to achieve with the grant. I don't know if that's something that you can discuss at this point, but I think we have some idea, but it would be interesting to just hear how that exercise is advancing and what the prospects might be for BARDA.

然後作為關於 BARDA 的後續問題，我希望更好地了解您希望透過這筆撥款實現什麼目標。我不知道您現在是否可以討論這個問題，但我認為我們有一些想法，但聽聽這項演習的進展情況以及 BARDA 的前景會很有趣。

The last question that I have is, would that evolve to potentially become something that could incorporate orders. It's unclear if the administration is currently concerned about bird flu or other influenza spreading. But just interested to know what it takes to kind of move forward to actually get to orders should the BARDA grant be issued?

我的最後一個問題是，這是否可能演變成可以合併訂單的東西。目前尚不清楚政府是否擔心禽流感或其他流感的蔓延。但我感興趣的是知道，如果 BARDA 撥款發放，需要採取哪些措施才能真正獲得訂單？

Sure, Seamus. I'll provide some initial responses, and then I'll welcome Nicole Davarpanah to supplement. So regarding our upcoming meeting with the FDA and regards to your question, the difference from the Type C meeting, we don't have an expectation of substantial differences. We largely reached alignment with the FDA in our Type C meeting in our discussions regarding the Phase III plan. The difference is that meeting took place in May before the NAVIGATE Phase IIb results were available.

當然，謝默斯。我將提供一些初步回應，然後歡迎 Nicole Davarpanah 進行補充。因此，關於我們即將與 FDA 舉行的會議以及關於您的問題，與 C 類會議的區別，我們並不期望有實質性的差異。在 C 類會議上，我們在討論第三階段計劃時與 FDA 基本達成了一致。不同之處在於，會議於 5 月舉行，當時 NAVIGATE IIb 階段的結果尚未公佈。

Now that we have the results, this is the first opportunity to discuss those results within the context of the Phase III plan. Obviously, based on the strength of the Phase III data and the strong safety that we observed. We don't anticipate substantial differences from that discussion. Regarding BARDA, the -- as you are aware, when you submit these, there is a base period and option period.

現在我們有了結果，這是在第三階段計劃的背景下討論這些結果的第一個機會。顯然，基於第三階段資料的強度和我們觀察到的強大安全性。我們預期此次討論不會產生實質分歧。關於 BARDA，如您所知，當您提交這些文件時，有一個基準期和選擇期。

We have expectations that the base period will, if funded, would fund manufacturing, in particular, the onshoring of manufacturing to the US. Then there are various options for the option period that which exercised could result in substantial funding to support additional clinical studies.

我們預計，如果獲得資金，基期將用於資助製造業，特別是製造業轉移到美國。然後，在選擇期內有各種選擇，這些選擇一旦行使，可能會產生大量資金來支持額外的臨床研究。

And then finally, regarding any orders from BARDA, that would come in the form of emergency use authorization in the event of a bird flu outbreak. We believe that based on the strength of the Phase IIb results, that would be an option should there be an outbreak. I would not anticipate a stocking order for CD388 in the absence of an emergency use authorization, however.

最後，關於 BARDA 的任何命令，這些命令都將以在發生禽流感疫情時緊急使用授權的形式發出。我們相信，基於 IIb 期試驗結果的強勁表現，如果爆發疫情，這將是一個選擇。然而，如果沒有緊急使用授權，我不會預期 CD388 的庫存訂單。

So I'll invite Nicole to provide any additional color on those questions. Nicole?

因此，我將邀請妮可對這些問題提供更多解釋。妮可？

Thank you, Jeff. I think you captured it quite nicely (inaudible). I think going back to the first point, we -- as Jeff mentioned, we had a significant amount of alignment with the FDA on our trial population, the study design and endpoints. But of course, that was before the benefit of having this nice Phase II data.

謝謝你，傑夫。我認為你捕捉得很好（聽不清楚）。我想回到第一點，正如傑夫所提到的，我們在試驗人群、研究設計和終點方面與 FDA 達成了高度一致。但當然，那是在獲得第二階段的良好數據之前。

So we will then have this meeting currently to kind of align with them further in case there's any changes, which we do not anticipate to the study design. And once we have received the meeting minutes, we will share openly any changes that have potentially been made.

因此，我們目前將召開這次會議，以進一步與他們保持一致，以防出現任何我們預計不會對研究設計產生的影響。一旦我們收到會議記錄，我們將公開分享可能做出的任何更改。

Eric Schmidt, Cantor Fitzgerald.

艾瑞克·施密特、康托·費茲傑拉。

Well thanks for taking my question. Congrats on just a wonderful second quarter. Maybe just to continue Seamus' line of discussion around the upcoming FDA meeting, I assume first it's in August because I think you need to schedule those within 60 days, so you can correct me if my time lines are off. But how would you plan to update investors on the outcome from that meeting?

好的，感謝您回答我的問題。恭喜您第二季取得如此出色的成績。也許只是為了繼續 Seamus 關於即將舉行的 FDA 會議的討論，我首先假設它是在 8 月份，因為我認為您需要在 60 天內安排這些會議，所以如果我的時間表不對，您可以糾正我。但是您打算如何向投資者通報這次會議的結果呢？

What actual points of discussion or questioning do you plan to put forth to the FDA? And then do you also plan to submit for a commissioner voucher? It would seem that CD388 might be a good fit for a national priority.

您計劃向 FDA 提出哪些實際討論或質疑要點？那麼，您還打算申請專員憑證嗎？看來 CD388 很適合成為國家優先項目。

Thank you.

謝謝。

Sure, Eric. Yes, all good questions. As discussed in the response to Seamus' question regarding the FDA meeting, this is the first opportunity really to discuss with them the Phase III plan in the context of the Phase IIb data. That meeting has been scheduled, and we expect that it will occur by the end of this month.

當然，埃里克。是的，都是很好的問題。正如在回答 Seamus 關於 FDA 會議的問題時所討論的那樣，這是第一次有機會在 IIb 期數據的背景下與他們真正討論 III 期計劃。該會議已經安排好，我們預計將於本月底舉行。

In response to your question about communication of the outcome of that meeting, we will await the receipt of the FDA minutes and then communicate those results and the results of those minutes in detail.

關於您關於傳達該會議結果的問題，我們將等待收到 FDA 會議記錄，然後詳細傳達這些結果以及會議記錄的結果。

With respect to your other question, I think about the CMPD voucher, we have submitted a statement of interest to -- it was a 350 word statement of interest, and we have yet to receive a response. I agree that CD388 would appear to be a very good fit. And was there another question, Eric, that I missed?

關於您的另一個問題，我想到了 CMPD 代金券，我們已經提交了一份意向聲明——這是一份 350 字的意向聲明，但我們尚未收到回應。我同意 CD388 看起來非常合適。艾瑞克，還有其他問題我遺漏了嗎？

I think you got it, unless you're willing, Jeff, to talk a little bit more about what you want to hear from the agency in your pre-Phase III meeting before having a go decision on the season.

我想你明白了，傑夫，除非你願意在對本賽季做出決定之前，在第三階段之前的會議上多談談你想從代理商那裡聽到什麼。

Yes. And again, I'll respond, and then I'll invite Nicole to provide any other color. Really, it's to corroborate the agreement we reached in our Type C meeting. So we haven't disclosed the details of that because obviously, that can change based on the end of Phase II meeting. So we will discuss those results when they become available in the form of the meeting minutes from the FDA.

是的。再次，我會做出回應，然後我會邀請妮可提供任何其他顏色。確實，這是為了證實我們在 C 類會議上達成的協議。因此，我們還沒有透露相關細節，因為很明顯，這可能會根據第二階段會議的結束而改變。因此，當 FDA 以會議記錄的形式公佈這些結果時，我們將對其進行討論。

We don't anticipate substantial changes because the results of the NAVIGATE study were pretty much in alignment with the expectations that we discussed with the FDA in the Type C meeting. Nicole, any other color you would like to add to that?

我們預計不會發生實質變化，因為 NAVIGATE 研究的結果與我們在 C 類會議上與 FDA 討論的預期基本一致。妮可，你想添加其他顏色嗎？

Thank you, Jeff. No, nothing further to add.

謝謝你，傑夫。不，沒什麼好補充的。

Thank you very much both.

非常感謝你們兩位。

Brian Abrahams, RBC.

布萊恩·亞伯拉罕斯，RBC。

Hi everyone, thanks for taking our questions. This is Nevin on for Brian. I just wanted to follow up on -- a little bit more on the Phase III design that you proposed. So you're planning to enroll a more immunocompromised high-risk population. So could there be a greater chance that the trial could reach the needed number of events earlier than the NAVIGATE trial had reached those events?

大家好，感謝您回答我們的問題。這是 Nevin 為 Brian 主持的節目。我只是想跟進一下——稍微多了解一下您提出的第三階段設計。所以您計劃招募免疫功能低下的高危險群。那麼，該試驗是否更有可能比 NAVIGATE 試驗更早達到所需的事件數量？

And can you explain some of the reasoning behind enrolling the trial over two to three influenza seasons, is that just the one season as the NAVIGATE trial? And then could you also remind us on the evidence that you've generated to date that suggests 388 can be redosed? And then do you imagine that regulators would want to see redosing potential -- potentially in the pivotal trial?

您能否解釋一下在兩到三個流感季節進行試驗的原因，是否只在其中一個季節進行 NAVIGATE 試驗？然後，您能否提醒我們，您迄今為止提供的證據顯示 388 可以重新使用？那麼，您是否認為監管機構希望看到重新給藥的可能性—可能在關鍵試驗中？

Sure. Yes. Good questions. Can you repeat the first question, please?

當然。是的。好問題。您能重複第一個問題嗎？

Yes, of course. So just given that the population that you're planning to enroll is more immunocompromised and high risk, do you think that there's a greater chance that the trial could reach that -- the needed number of events sooner than the NAVIGATE trial had?

是的當然。因此，考慮到您計劃招募的人群免疫功能低下且風險較高，您是否認為該試驗更有可能比 NAVIGATE 試驗更快地達到所需的事件數量？

Yes. Great question. Actually, we believe the opposite that the attack rate in the placebo arm of the study will be lower than that in the Phase IIb. And the main reason for that is even though -- and I think what your question was alluding to is that this is a more vulnerable patient population. At the same time, they are a more protected patient population.

是的。好問題。事實上，我們的看法恰恰相反，即研究中安慰劑組的發生率將低於 IIb 期。主要原因是——我認為你的問題暗示的是，這是一個更脆弱的患者群體。同時，他們也是受到更多保護的患者群。

And so they go because of the inadequacy of vaccines and protecting these patients, they are highly protected and also a big difference is that we believe that at least half, if not more, of these subjects will be vaccinated. Even though the vaccine effectiveness will be modest at best, it does offer some protection.

因此，由於疫苗不足，保護這些患者的能力有限，他們受到了高度保護，而且一個很大的區別是，我們相信至少有一半，甚至更多的人會接種疫苗。儘管疫苗的有效性充其量只是適度的，但它確實提供了一定的保護。

In regard to your other question on redosing, yes, we do anticipate conducting a redosing study that is planned. And it's basically a continuation of redosing that we had conducted in our first Phase I study where we are looking for antidrug antibodies. We didn't see any substantial evidence of that. We also looked for those in the Phase IIb study.

關於您關於重新給藥的另一個問題，是的，我們確實預計將進行計劃中的重新給藥研究。這基本上是我們在第一階段研究中進行的重新給藥的延續，我們正在尋找抗藥性抗體。我們沒有看到任何實質的證據。我們還在 IIb 期研究中尋找這些。

But we have this great resource in the subjects we enrolled in the NAVIGATE Phase IIb study that have received a dose -- three different doses of CD388. So we're going to take advantage of that resource and take a subset of those subjects for a redosing study that we anticipate starting shortly.

但是，我們在 NAVIGATE IIb 期研究中招募的受試者中擁有豐富的資源，他們已經接受了三種不同劑量的 CD388。因此，我們將利用該資源，並從中選取一部分受試者進行重新給藥研究，我們預計研究很快就會開始。

Okay, thank you so much. And then what do you think the time lines for that would be? Would that be kind of prior to the initiation of the pivotal trial or just --

好的，非常感謝。那您認為這個時間表是怎麼樣的呢？這是在關鍵審判開始之前，還是只是--

Yes, we will -- good question. We'll communicate that after we receive the meeting minutes from our upcoming end of Phase II meeting because we'll be discussing that with the FDA.

是的，我們會的——好問題。我們將在收到即將結束的第二階段會議的會議記錄後傳達這一消息，因為我們將與 FDA 討論此事。

Okay great. Thank you so much.

好的，太好了。太感謝了。

Joseph Stringer, Needham & Company.

約瑟夫·斯特林格，Needham & Company。

Good afternoon. This is Eddie on for Joey. Just two from us. First, just to kind of a follow up on the previous question. I'm wondering what assumptions are built into that cash runway? And does this include that redosing trial as well as the potential for a second Phase III trial?

午安.這是 Eddie 代替 Joey 上場的。距離我們只有兩個。首先，只是想跟進一下上一個問題。我想知道這條現金流都包含哪些假設？這是否包括重新給藥試驗以及第二階段 III 期試驗的可能性？

And then a follow-up, just looking at the landscape, Sanofi guided for mid-teen percent declines in their food business this year, partly due to the US pricing pressures. Just curious what the -- what read-through might be possible for your business and maybe some commercial outlook for CD388.

接下來，僅從整體情況來看，賽諾菲預計今年其食品業務將出現百分之十五左右的下滑，部分原因是美國的價格壓力。只是好奇您的業務可能具有什麼樣的解讀，以及 CD388 的一些商業前景。

Sure. For the first question on cash runway, let me turn that one over to Frank Karbe, our CFO. Frank?

當然。關於現金流的第一個問題，讓我把它交給我們的財務長弗蘭克·卡貝 (Frank Karbe)。坦率？

Yes, sure. So look, with the $500-plus million in cash on hand now, we believe we are adequately funded through the end of our Phase III program, including the additional studies that we have cited here on this call and also including different potential scenarios, how the Phase III could play out.

是的，當然。所以，現在我們手頭上有 5 億多美元的現金，我們相信有足夠的資金來完成我們的第三階段計劃，包括我們在這次電話會議上提到的額外研究，還包括第三階段可能如何進行的不同潛在情景。

And then with respect to the second question, if you could repeat that, I know it was a commercial question regarding the Sanofi product, and I will turn that over to Jim Beitel, our Chief Business Officer. So if you could repeat that question first.

然後關於第二個問題，如果您可以重複一下，我知道這是一個關於賽諾菲產品的商業問題，我將把這個問題交給我們的首席商務官 Jim Beitel。所以如果你可以先重複這個問題。

Yes, absolutely. Just on Sanofi's earnings call, they guided for a mid-teen percent decline this year in their approved business. And just seeing if there's any read-through to your business or commercial outlook for CD388?

是的，絕對是。就在賽諾菲的收益電話會議上，他們預計今年核准業務將下降百分之十五左右。只是想看看您對 CD388 的業務或商業前景有何看法？

Yes. Jim --

是的。吉姆--

Certainly. Yes, I appreciate the question. And certainly, there's been a lot of downward pressure on vaccine businesses, I think not just Sanofi's but others as well. And a lot of that has to do with things unrelated to CD388. And I think it underscores the importance of our commercial strategy and development strategy, really focusing in on these subjects with the greatest risk.

當然。是的，我很感謝你提出這個問題。當然，疫苗業務面臨很大的下行壓力，我認為不只是賽諾菲，其他公司也是如此。其中很多都與 CD388 無關的事情有關。我認為這強調了我們的商業策略和發展策略的重要性，並真正關注這些風險最大的主題。

And there, the burden of illness is highest and the value proposition that we've demonstrated in the NAVIGATE study and intend to demonstrate in the Phase III, I think, really brings something unique to the marketplace. And so certainly, downward pressure on vaccines, but a very different commercial model there relative to the one that we're considering for CD388.

那裡的疾病負擔最重，我們在 NAVIGATE 研究中展示的價值主張以及打算在第三階段展示的價值主張，我認為確實為市場帶來了一些獨特的東西。因此，疫苗肯定會面臨下行壓力，但與我們正在考慮的 CD388 相比，疫苗的商業模式非常不同。

Okay, thanks so much.

好的，非常感謝。

Roy Buchanan, Citizens.

羅伊·布坎南，公民。

Okay, great. Thanks for taking the question. Just a couple of quick ones. I guess, you mentioned the scientific presentations later this year. Have you been accepted at any conferences? And could you tell us what those are? And any key data that we should be looking out for? For example, are you going to have the ADA data from the Phase IIb there?

好的，太好了。感謝您回答這個問題。僅舉幾例。我想，您提到了今年稍後的科學演講。您曾被任何會議接受過嗎？您能告訴我們這些是什麼嗎？我們應該關注哪些關鍵數據？例如，您是否會在那裡獲得來自 IIb 階段的 ADA 數據？

Yes. Good questions. We have submitted to the ISIRV an IDWeek. And Les, do you want to provide a little color on what -- whether those have been accepted yet? I don't believe they have, but we have high expectations that they will be accepted.

是的。好問題。我們已經向 ISIRV 提交了一份 IDWeek。萊斯，您能否稍微說明一下這些是否已經被接受了？我不相信他們已經接受了，但我們對他們被接受抱有很高的期望。

Les?

萊斯？

Sure, Jeff. Yes, we have two abstracts -- we are submitting two abstracts to ISIRV, one to summarize the Phase IIb data and another that has been accepted for an oral presentation, and that's going to be on our activity against a contemporary H5N1 strain, a nonclinical ferret efficacy model, where we demonstrated robust efficacy at [ISIRV] in the fall, we will also be presenting -- we've submitted an abstract where we're going to be describing the PK/PD relationships for activity in the Phase IIb trial with CD388.

當然，傑夫。是的，我們有兩份摘要——我們正在向 ISIRV 提交兩份摘要，一份總結了 IIb 期數據，另一份已被接受進行口頭報告，該摘要將介紹我們針對當代 H5N1 毒株、非臨床雪貂功效模型的活性，我們在秋季的 [ISIRV] 上證明了該模型的強大功效，我們還將進行工作報告——我們已經在秋季的 [ISIRV] 上證明了該模型的強大功效，我們還將進行工作報告——我們已經描述了一份摘要 38 /b

Okay. Great. And then apologies for the non-CD388 question, keep it quick. But just curious what's next in your view in terms of targets and potential timing when we might see some developments there?

好的。偉大的。然後對於非 CD388 問題表示歉意，請保持簡短。但我只是好奇，就目標和潛在時間而言，您認為下一步是什麼，我們何時可能會看到一些發展？

Sure. No specific plans at the moment. Certainly, our oncology program is a great asset, and we have an opportunity to advance that, but we have not determined a specific time frame when we will be advancing that into the clinic.

當然。目前沒有具體計劃。當然，我們的腫瘤學計畫是一項巨大的財富，我們有機會推進它，但我們還沒有確定將其推進到臨床的具體時間框架。

Okay, perfect. Thank you.

好的，完美。謝謝。

(Operator Instructions)

（操作員指示）

Sarah Nik, H.C. Wainwright.

莎拉·尼克、H.C. 溫賴特。

Hi and thanks for taking the question. Just kind of following up on the previous one, I wanted to get a sense of the resolution of the kind of data you'll be presenting at these conferences. You mentioned some PK/PD data. Will you be presenting anything with regards to individual subgroup data at these meetings, maybe with regards to age or region, preventative efficacy outcomes or anything along those lines?

您好，感謝您提出這個問題。只是跟進上一個問題，我想了解您將在這些會議上展示的資料類型的解決方案。您提到了一些 PK/PD 數據。您會在這些會議上展示有關個人亞組資料的任何內容嗎？也許是有關年齡或地區、預防功效結果或類似的任何內容？

Thank you.

謝謝。

Yes. We will be sharing the details of that when they -- when they are accepted. But certainly, what you mentioned is encompassed in some of the abstracts that have been submitted. Les, any other color you'd like to share on that?

是的。當它們被接受時，我們將分享詳細資訊。但可以肯定的是，您所提到的內容已經包含在一些已提交的摘要中。Les，您還想分享其他顏色嗎？

Hi, Sara. No, Jeff, you covered it well. Once the abstracts are published, we'll be able to provide more clarity on what will be presented.

你好，薩拉。不，傑夫，你講得很好。摘要發布後，我們將能夠更清楚地說明將要呈現的內容。

All right, great. Thank you.

好的，太好了。謝謝。

This concludes the question-and-answer session. I'd like to turn the conference back over to Dr. Jeff Stein for any closing remarks.

問答環節到此結束。我想將會議交還給 Jeff Stein 博士，請他做最後發言。

Well, thank you all for joining us today. We greatly appreciate your interest in Cidara and hope you enjoy your evening. Thank you.

好吧，感謝大家今天加入我們。我們非常感謝您對 Cidara 的關注，並希望您度過一個愉快的夜晚。謝謝。

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

會議現已結束。感謝您參加今天的演講。您可以斷開連線。