Vistagen Therapeutics Inc (VTGN) 2025 Q2 法說會逐字稿

Good afternoon, ladies and gentlemen and welcome to the Vistagen Therapeutics fiscal year 2025, second-quarter corporate update conference call. (Operator Instructions)

下午好，女士們、先生們，歡迎參加 Vistagen Therapeutics 2025 財年第二季公司最新情況電話會議。（操作員說明）

I would now like to turn the call over to Mark McPartland, Senior Vice President, Investor Relations at Vistagen. Please go ahead.

我現在想將電話轉給 Vistagen 投資者關係資深副總裁 Mark McPartland。請繼續。

Thank you operator. Good afternoon, everyone and welcome to Vistagen fiscal year 2025 second-quarter, corporate update conference call and webcast. Earlier this afternoon, we filed our quarterly report with the securities exchange commission on the SEC form 10-Q for second-quarter that ended September 30, 2024 and we also issued a press release providing an overview of our progress across our lead neuroscience programs.

謝謝運營商。大家下午好，歡迎來到 Vistagen 2025 財年第二季公司更新電話會議和網路廣播。今天下午早些時候，我們向證券交易委員會提交了截至2024 年9 月30 日的第二季度10-Q 表格的季度報告，我們還發布了一份新聞稿，概述了我們領先的神經科學項目的進展情況。

We encourage you to review the release in our 10-Q which can be found in the investors section of our website. We will make forward-looking statements regarding our business during today's call based on our current expectations and information. These forward-looking statements speak only as of today except as required by law. We do not assume any duty to update any forward-looking statements made today or in the future.

我們鼓勵您查看我們網站的投資者部分中的 10-Q 中的發佈內容。在今天的電話會議中，我們將根據我們目前的預期和資訊做出有關我們業務的前瞻性聲明。除法律要求外，這些前瞻性陳述僅在今天發表。我們不承擔更新今天或將來做出的任何前瞻性陳述的責任。

Of course, forward-looking statements involve risks and uncertainties, and our actual results could differ materially from those anticipated by any forward-looking statements we make today. Additional information concerning risk factors that could affect our business and financial results is included in our fiscal year 2025 second-quarter form 10-Q for the period ending September 30, 2024. And in future filings that we make with the SEC from time to time, all of which again are on our website in the investors section on the SEC website.

當然，前瞻性陳述涉及風險和不確定性，我們的實際結果可能與我們今天所做的任何前瞻性陳述的預期有重大差異。有關可能影響我們業務和財務業績的風險因素的更多資​​訊包含在截至 2024 年 9 月 30 日的 2025 財年第二季 10-Q 表格中。在我們以後不時向 SEC 提交的文件中，所有這些文件都會再次出現在我們網站的 SEC 網站投資者部分。

With the formalities completed, I would like to warmly welcome our stockholder sell side analysts and others interested in our programs in progress. I'm joined on our call today by Shawn Singh, our Chief Executive Officer; Cindy Anderson, our Chief Financial Officer and Joshua Prince, our Chief Operating Officer. Shawn will discuss our recent highlights in our lead neuroscience programs and Cindy will discuss our second-quarter financial results.

手續完成後，我熱烈歡迎我們的股東、賣方分析師和其他對我們正在進行的專案感興趣的人。我們的執行長肖恩辛格 (Shawn Singh) 也參加了今天的電話會議。辛蒂·安德森（Cindy Anderson）是我們的財務官，約書亞·普林斯（Joshua Prince）是我們的營運長。肖恩將討論我們最近在主要神經科學計畫中的亮點，辛蒂將討論我們第二季度的財務表現。

At the conclusion of our prepared remarks, as the operator has already noted, there will be a brief opportunity for questions from the sell side analysts. As a reminder, this call is being webcast and will be available for replay after completion, the replay link again can be found on our website event section. Shawn.

正如運營商已經指出的那樣，在我們準備好的演講結束時，賣方分析師將有一個簡短的提問機會。謹此提醒，本次電話會議正在進行網路直播，結束後可重播，重播連結可再次在我們網站的活動部分找到。肖恩.

Thank you, Mark. Good afternoon, everyone and thank you for joining our call today. As the Neuroscience Renaissance continues, we are advancing a Vistagen in a Neuroscience pipeline that's unlike any other in the industry with multiple clinical stage product candidates in Phase 2 and Phase 3 development. Each from a new class of potential intranasal therapies that we call pherines.

謝謝你，馬克。大家下午好，感謝您今天加入我們的電話會議。隨著神經科學復興的繼續，我們正在神經科學管道中推進 Vistagen，這與業內其他產品不同，在 2 期和 3 期開發中擁有多個臨床階段候選產品。每一種都來自一種新的潛在鼻內療法，我們稱之為 pherines。

Each has a differentiated mechanism of action and differentiated safety. So, we're up, we are with this pipeline, advancing multiple opportunities to set new standards of care in several high prevalence pharmaceutical markets. Distinguished from all systemic medications that are currently approved by the FDA. Each intranasal pherine product candidate in our lead programs and that includes fasedienol for social anxiety disorder, itruvone for major depressive disorder and PH80 for menopausal hot flashes.

每一種都有不同的作用機制和不同的安全性。因此，我們已經開始，我們正在利用這條管道，推進多種機會，在幾個高流行的醫藥市場上製定新的護理標準。與目前 FDA 批准的所有全身性藥物不同。我們的主導項目中的每一種鼻內菲林候選產品都包括用於治療社交焦慮症的 fasedienol、用於治療重度憂鬱症的 itruvone 以及用於治療更年期潮熱的 PH80。

Each is designed and formulated to activate key nose to brain neurocircuitry within milliseconds to achieve the desired therapeutic effects and all without requiring systemic absorption or binding to neurons in the brain.

每一種都經過設計和配製，可在幾毫秒內激活關鍵的鼻子到大腦神經迴路，以達到所需的治療效果，並且不需要全身吸收或與大腦中的神經元結合。

We have observed statistically significant efficacy and favourable safety data in each of our lead intranasal pherine development programs. For fasedienol in a Phase 3 trial for the acute treatment of social anxiety disorder, for itruvone in a Phase 2A trial for the treatment of major depressive disorder and for PH80 in a Phase 2A trial for menopausal hot flashes. It is these successes seen with multiple varying product candidates across multiple indications that drive our confidence in the power and the elegance of nose to brain neurocircuitry and the enormous potential of our internasal pherine platform.

我們在每個領先的鼻內菲林開發項目中都觀察到了統計上顯著的療效和良好的安全性數據。fasedienol 處於急性治療社交焦慮症的 3 期試驗中，itruvone 處於治療重度憂鬱症的 2A 期試驗中，PH80 處於治療更年期潮熱的 2A 期試驗中。正是這些針對多種適應症的不同候選產品所取得的成功，增強了我們對鼻腦神經迴路的力量和優雅以及我們的鼻內菲林平台的巨大潛力的信心。

Currently, there is no FDA approved medication for the acute treatment of social anxiety disorder, which is a mental health disorder affecting over 30 million adults in the US. And our goal is to fill a major acute treatment gap in SAD with fasedienol and deliver new hope and new optimism to the millions of individuals who are anxious and fear, embarrassment, humiliation, and judgment when facing anxiety, provoking social and performance situations in their daily life.

目前，FDA 尚未批准用於急性治療社交焦慮症的藥物，社交焦慮症是一種影響美國超過 3,000 萬成年人的精神健康疾病。我們的目日常生活。

Last year, we reported positive results from our PALISADE-2 Phase 3 trial of fasedienol for the acute treatment of SAD. And this year with the goal of complementing the success of PALISADE-2, we've initiated our replicate PALISADE-3 and PALISADE-4 Phase 3 trials on time and as planned.

去年，我們報告了 Fasedienol 急性治療 SAD 的 PALISADE-2 3 期試驗的正面結果。今年，為了補充 PALISADE-2 的成功，我們按計劃按時啟動了重複的 PALISADE-3 和 PALISADE-4 3 期試驗。

With those milestones now completed, we are now laser focused on efficient execution toward top line results from both studies next year. And if successful, we believe either PALISADE-3 or PALISADE-4 together with PALISADE-2, could provide sufficient evidence of safety and efficacy to support the submission of an NDA to the FDA for fasedienol for the acute treatment of anxiety in adults with SAD.

隨著這些里程碑的完成，我們現在專注於高效執行，以實現明年這兩項研究的最高結果。如果成功，我們相信 PALISADE-3 或 PALISADE-4 與 PALISADE-2 一起可以提供足夠的安全性和有效性證據，以支持向 FDA 提交 fasedienol 用於急性治療 SAD 成人焦慮症的 NDA 。

Our itruvone program has shown exciting potential as a new non-systemic standalone treatment for major depressive disorder and we are preparing for planned Phase 2B development in the US. Based on the Phase 2A clinical data, itruvone has the potential to relieve MDD symptoms rapidly and without many of the unwanted side effects associated with current systemic antidepressants, especially weight gain and sexual dysfunction.

我們的 itruvone 計畫作為一種新的非系統性獨立治療重度憂鬱症的藥物已顯示出令人興奮的潛力，我們正在為計劃在美國進行的 2B 期開發做準備。根據 2A 期臨床數據，itruvone 有潛力快速緩解 MDD 症狀，且沒有與目前全身性抗憂鬱藥物相關的許多不良副作用，特別是體重增加和性功能障礙。

Our PH80 program for menopausal hot flashes is also progressing based on positive Phase 2A clinical data, our non-systemic hormone free varying product candidate has game changing potential in this major women's health market in which women are faced with a very limited opportunity for treatment options.

我們針對更年期潮熱的PH80 項目也在基於積極的2A 期臨床數據的基礎上取得進展，我們的非全身性激素自由變化產品候選者在這個主要的女性健康市場中具有改變遊戲規則的潛力，在這個市場中，女性面臨非常有限的治療選擇機會。

We're advancing PH80 through the remaining nonclinical programs and CMC requirements to support our submission of a US IND next year. The intent for that is to facilitate our plans for further Phase 2 development of PH80 for treatment of menopausal hot flashes in the US.

我們正在透過剩餘的非臨床項目和 CMC 要求推進 PH80，以支持我們明年提交美國 IND。這樣做的目的是促進我們在美國進一步進行 PH80 治療更年期潮熱二期開發的計劃。

I'll now hand the call over to Cindy Anderson, our CFO to summarize our financials from the last quarter, Cindy.

現在，我將把電話交給我們的財務長辛蒂·安德森 (Cindy Anderson)，總結上一季我們的財務狀況，辛蒂。

Thank you, Shawn. As Shawn mentioned, I will highlight a few financial results from our fiscal year 2025 second-quarter. Research and development expenses were $10.2 million for the quarter ended September 30, 2024, compared to $3.9 million for the same period last year. The increase in R&D expenses was primarily due to an increase in clinical and development expenses related to our PALISADE Phase 3 program for fasedienol for the acute treatment of SAD, an increase in head count and an increase in consulting professional services.

謝謝你，肖恩。正如 Shawn 所提到的，我將重點介紹 2025 財年第二季的一些財務表現。截至 2024 年 9 月 30 日的季度，研發費用為 1,020 萬美元，而去年同期為 390 萬美元。研發費用的增加主要是由於與用於急性治療SAD的fasedienol的PALISADE 3期項目相關的臨床和開發費用的增加、人員數量的增加以及諮詢專業服務的增加。

General administrative expenses were $4.2 million for the quarter ended September 30, 2024 compared to $3.2 million the same period last year. The increase in G&A expenses was primarily due to an increase in head count and professional services fees.

截至 2024 年 9 月 30 日的季度一般管理費用為 420 萬美元，而去年同期為 320 萬美元。一般及行政費用的增加主要是因為員工人數和專業服務費的增加。

Our net loss attributed to common stockholders was $13 million for the quarter ended September 30, 2024 compared to $6.6 million for the same period last year. As of September 30, 2024 we had $97.6 million in cash, cash equivalents and marketable securities. As a reminder, please refer to our quarterly report on form 10-Q filed with the SEC this afternoon for additional details and disclosures. I will now hand the call back over to Shawn.

截至 2024 年 9 月 30 日的季度，我們歸屬於普通股股東的淨虧損為 1,300 萬美元，而去年同期為 660 萬美元。截至 2024 年 9 月 30 日，我們擁有 9,760 萬美元的現金、現金等價物和有價證券。謹此提醒，請參閱我們今天下午向 SEC 提交的 10-Q 表格季度報告，以了解更多詳細資訊和揭露資訊。我現在將把電話轉回給肖恩。

Thanks Cindy, leveraging our pioneering neuroscience, our deep understanding of nose to brain neurocircuitry and multiple positive clinical trials to date. Our fairing pipeline has the power and the potential to improve millions of lives who are affected by debilitating effects of neuroscience disorders to do that by replacing inadequate therapies and setting entirely new standards of care.

感謝辛迪，利用我們開創性的神經科學、我們對鼻子到大腦神經迴路的深刻理解以及迄今為止的多項積極的臨床試驗。我們的整流罩管道有能力和潛力改善數以百萬計受到神經科學疾病的衰弱影響的人的生活，透過取代不充分的療法和製定全新的護理標準來實現這一目標。

Our broad and our diverse neuroscience pipeline offers multiple shots at that core, at that core goal and our team is motivated and it's driven by the opportunities to disrupt treatment paradigms, improve lives and in turn, create potential value for our stockholders.

我們廣泛且多樣化的神經科學產品線為這一核心和核心目標提供了多種機會，我們的團隊充滿動力，並受到顛覆治療範式、改善生活並反過來為我們的股東創造潛在價值的機會的推動。

So on behalf of everyone [at this.] And once again, I want to thank you for your continued interest in our efforts and for your support. And we look forward to keeping you informed of our continuing progress.

因此，我代表大家[在此]再次感謝您對我們努力的持續關注和支持。我們期待讓您隨時了解我們的持續進展。

Thank you, Shawn. Operator, we would now like to open up the call for questions from the sell side analyst participating on the call today.

謝謝你，肖恩。營運商，我們現在想開始接受今天參加電話會議的賣方分析師的提問。

(Operator Instructions)

（操作員說明）

First question will be coming from Paul Matteis from Stifel.

第一個問題將由來自 Stifel 的 Paul Matteis 提出。

Hi there. This is Julian on for Paul. Thanks so much for taking my question and congrats on the progress. Just wondering if you could provide a little bit of color on the pace of enrolment so far. What are you hearing from investigators about the demand and enrolling in the study. And I was wondering if these parallel studies share trial sites or anything else that you could share about the sites that you've chosen for each study.

你好呀。這是保羅的朱利安。非常感謝您提出我的問題並祝賀我的進展。只是想知道您是否可以提供一些有關迄今為止註冊進度的信息。您從研究人員那裡聽到了有關研究需求和報名的資訊。我想知道這些平行研究是否共享試驗網站或您可以分享的關於您為每項研究選擇的網站的任何其他內容。

And then lastly a quick one can you just remind us on the timing of when you expect to have data here? Previously, you've said you're targeting mid '25 for PAL 3 and towards the end of 2025 for PAL 4, just curious if you're still tracking towards that goal? Thank you.

最後，您能簡單提醒一下我們您預計何時在此處獲得數據嗎？先前，您說過 PAL 3 的目標是 25 年中期，PAL 4 的目標是 2025 年底，只是好奇您是否仍在朝著這個目標前進？謝謝。

Hey, thanks Julian. I appreciate the question. Couple of things there, I'll try to do them sort of in reverse order in terms of timelines, still sticking with the guidance that we had previously laid out as you just articulated for, for PAL 3 and PAL 4 respectively. So, we're happy that we were able to initiate both of the studies on time. As I noted middle of the first half of this year for PAL 3 in the middle of the second half of this year for PAL 4.

嘿，謝謝朱利安。我很欣賞這個問題。其中有幾件事，我將嘗試在時間軸上以相反的順序進行，仍然堅持我們先前為 PAL 3 和 PAL 4 分別闡述的指導原則。因此，我們很高興能夠按時啟動這兩項研究。正如我所指出的，PAL 3 是在今年上半年中期推出的，PAL 4 是在今年下半年中期推出的。

So, there's tremendous excitement across the [Pis] and the site staff that we've been able now to bring together for PALISADE-3 and PALISADE-4, you can imagine on the other side of the PALISADE-2 success, We've got 16 sites now they're activated for PALISADE-3 and another and a dozen for PALISADE-4. So the color I can give you is again, we, this is a very important indication.

因此，[Pis] 和我們現在為 PALISADE-3 和 PALISADE-4 聚集在一起的現場工作人員都感到非常興奮，您可以想像 PALISADE-2 成功的另一面，我們已經現在有16 個站點被激活用於PALISADE-3，另外還有十幾個站點被活化用於PALISADE-4。所以我可以給你的顏色是，我們，這是一個非常重要的指示。

It's very clear throughout the research community and a lot of these sites of course, have psychiatrists that have been treating patients for a very long time and they just haven't seen anything new in a very long time, let alone something for the acute treatment of social anxiety disorder, which is so important with this disorder is enabling people to engage and not have fear of engaging in the things that stress them in their life, that create anxiety and opportunity costs in their life because they're self-isolating or withholding from engaging.

整個研究界和許多這樣的網站都非常清楚，當然，精神科醫生已經治療了很長時間的患者，他們只是很長一段時間沒有看到任何新的東西，更不用說急性治療的東西了社交焦慮症的重要原因是使人們能夠參與而不是害怕參與生活中給他們帶來壓力的事情，這些事情會在他們的生活中產生焦慮和機會成本，因為他們自我孤立或拒絕參與。

So, it's really exciting time across all both studies. There's no overlap in the sites from in either of the two studies. Of course, I've got sites from PALISADE-1 and PALISADE-2 that we've been very happy with from the past. So, I'd say overall, we are really excited to work with our CRO with the sites with our internal team.

所以，這兩項研究都是非常令人興奮的時刻。這兩項研究中的位點都沒有重疊。當然，我已經從 PALISADE-1 和 PALISADE-2 獲得了我們過去一直非常滿意的網站。因此，總的來說，我們非常高興能夠與我們的 CRO 以及我們的內部團隊一起在這些網站上合作。

We've really enhanced surveillance with our own owned assets as well as augmenting that with what we've got as resources from the CRO. So, there's a lot of intense training, there's very close surveillance and adherence to the protocols which is a very important, obviously to control variability. So, I think overall, we're happy with how things are going. (technical difficulty)

我們確實利用自己擁有的資產加強了監控，並利用 CRO 提供的資源加強了監控。因此，需要進行大量的密集培訓，進行非常密切的監視並遵守協議，這對於控制變異性顯然非常重要。所以，我認為總的來說，我們對事情的進展感到滿意。（技術難度）

Josh, you want to add anything to that.

喬什，你想添加任何內容。

Yeah, I would just, I'd love to add a little bit of color to the [PI] excitement that you mentioned. We've now had in person investigator meetings for both PALISADE-3 and PALISADE-4 and what really comes out there is we have the opportunity to speak with [Pis] that are there and really express their excitement and enthusiasm to participate in a study like this. That's really unlike any other study that they've done before or kind of have come across their plates now. So just want to add that color that we really do see that, excitement, enthusiasm, engagement from the [PIS] and the desire to do these studies.

是的，我只是想為你提到的 [PI] 興奮添加一點色彩。我們現在已經召開了 PALISADE-3 和 PALISADE-4 的面對面研究者會議，真正的結果是我們有機會與在場的 [Pis] 交談，並真正表達他們參與研究的興奮和熱情像這樣。這確實不同於他們之前做過的或現在遇到的任何其他研究。因此，我只想加入我們確實看到的那種色彩：[PIS] 的興奮、熱情、參與以及進行這些研究的願望。

It's a good point and that just came out. We had a recent town hall with the sites is something that we do from time to time where it's sort of like a fireside chat with me and with the rest of the team. So, keeping the momentum is always key when you're trying to execute efficiently a program, especially with parallel studies in motion and it always helps when what you're working on is that the leading edge of trying to treat people who have been dealing with this disorder for decades. But thanks for the question, Julian, appreciate it.

這是一個很好的觀點，而且剛剛出來。我們最近在網站上舉行了一次市政廳會議，這是我們不時會做的事情，有點像是與我和團隊其他成員進行爐邊聊天。因此，當你試圖有效地執行一個專案時，保持動力始終是關鍵，尤其是在進行平行研究的情況下，當你正在努力治療那些一直在處理問題的人時，它總是有幫助的。十年來一直患有這種疾病。但謝謝你的提問，朱利安，謝謝。

Next in line will be coming from Andrew Tsai from Jeffrey.

下一個將是來自 Jeffrey 的 Andrew Tsai。

Hey, good afternoon. Thanks for the updates, appreciate you taking my questions. Maybe a tangential question from before that was just asked. But for the Phase 3 studies are both of them that are underway. What are you seeing on the front lines that gives you the confidence. It's definitely different this time for fasedienol or maybe talk about how sites are operating the rigor of these study protocols, whether public speaking challenge is being done correctly and so forth. Thanks.

嘿，下午好。感謝您的更新，感謝您回答我的問題。也許是之前問的一個無關緊要的問題。但三期研究都正在進行中。你在前線看到的是什麼給了你信心。這次對於 fasedienol 來說肯定有所不同，或者可能會談論網站如何嚴格執行這些研究協議，公開演講挑戰是否正確完成等等。謝謝。

Thanks, Andrew. Appreciate the question, one thing of course is significantly different now than where we were even during PALISADE-2, let alone earlier than that during the pandemic. It's just the ability to have person to person contact to have in person training like Josh mentioned, in-person investigators meetings mean a tremendous amount to be able to regularly and predictably have site visits and also have subjects schedule each phase in each visit during their challenge sequence.

謝謝，安德魯。感謝這個問題，當然，現在的情況與 PALISADE-2 期間的情況有很大不同，更不用說早於大流行期間了。這只是像喬許提到的人與人接觸進行面對面培訓的能力，面對面的調查員會議意味著能夠定期、可預測地進行現場訪問，並讓受試者在每次訪問期間安排每個階段的時間。

It is all different. It is just fundamentally different. The attrition rates that we typically saw before at sites with site staff, we're just not seeing same thing with CROs, you're not seeing the kinds of things that would have been frustrating variability coming into to a protocol that the recipe is pretty clear and when it's followed, it helps tremendously. So that plus things that we've talked about before, right? No masks involved, no COVID related potential with the subjects in the study.

一切都不同了。這只是根本上的不同。我們之前在現場工作人員的現場通常看到的流失率，我們只是在 CRO 上沒有看到同樣的情況，你沒有看到那些令人沮喪的變化進入協議，配方很漂亮清晰，一旦遵循，就會有很大幫助。那麼加上我們之前討論過的事情，對吧？不涉及口罩，研究對像不存在與新冠病毒相關的可能性。

So there's just fundamental things that are different on a macro basis and then side by side on a micro basis and just having the ability for the protocol to not be novel. This is something of course, now that's on the third and the fourth lapse within the research community. So, the study design isn't new, the endpoint isn't new. So, all those things have really helped, I think with the pace of play and with the ability really to surveil and to hopefully make sure that we've got rigorous adherence to the protocol across all the sites.

因此，一些基本的東西在宏觀基礎上是不同的，然後在微觀基礎上並排存在，並且協議有能力不新穎。這是理所當然的事情，現在已經是研究界的第三次和第四次失誤了。因此，研究設計並不新鮮，終點也不新鮮。因此，我認為所有這些事情都確實有所幫助，包括遊戲的節奏和真正的監視能力，並希望確保我們在所有站點上嚴格遵守協議。

Mm. And that said, oh, go ahead. Sorry.

毫米。那就是說，哦，繼續吧。對不起。

No, I just want to give Josh a sense to add to it. Josh oversees the program primarily. So, I want to give you a chance, Josh, anything I missed.

不，我只是想讓喬希有一種補充的感覺。喬許主要負責監督該計劃。所以，我想給你一個機會，喬什，任何我錯過的機會。

Sure we could add to what you said and it kind of builds on the in-person piece. In addition to the in-person investigator meetings, we've had an in-person site initiation visit for every site, right? So it's kind of the double reinforcement of training and investigator meeting and then, a good 3 to 4 hours with the study staff in their site location again, hitting all the key details and pieces and components of what it takes to properly execute a public speaking challenge.

當然，我們可以添加您所說的內容，並且它是建立在面對面的作品之上的。除了面對面的調查員會議之外，我們還對每個站點進行了現場啟動訪問，對嗎？因此，這是培訓和調查員會議的雙重強化，然後，與研究人員再次回到現場進行 3 到 4 個小時的討論，以了解正確執行公開演講所需的所有關鍵細節和組成部分挑戰。

And then through the monitoring that Shawn mentioned, there have been specific examples where we've identified something that wasn't being done quite right. And the next day there's an intervention or a discussion or a retraining or a reminder. So those are the kinds of things that could not happen in our prior PALISADE studies and are happening now, which gives us again that confidence that we're getting the right patients and that we're reducing variability as much as possible across sites for the public speaking challenge.

然後透過肖恩提到的監控，有一些具體的例子，我們發現了一些做得不太正確的事情。第二天會有介入、討論、再訓練或提醒。因此，這些事情在我們之前的 PALISADE 研究中不可能發生，而現在正在發生，這再次讓我們相信我們正在找到合適的患者，我們正在盡可能減少不同地點之間的變異性公開演講挑戰。

Makes sense. And, in the unfortunate circumstance, should PALISADE 3 not hit stats? Do you still, would you still plan to move forward and complete PALISADE 4? Just given the turn of events that happened last time with PALISADE 1 and 2.

有道理。而且，在不幸的情況下，PALISADE 3 應該不會達到統計數據嗎？您仍然、仍然計劃繼續前進並完成 PALISADE 4 嗎？剛剛考慮到上次 PALISADE 1 和 2 發生的事件。

Yeah, 100%. No question about it Andrew. The whole program continues, that's what's the benefit of having a fully funded program. So, and we're in a spot now where in the very short order here, we will have initiated everything in '24 that we think we need to read out in '25 and that if positive would support our NDA in the early part of '26 for Fasedienol. So, yes, absolutely 100% regardless both studies will be run to completion.

是的，100%。毫無疑問安德魯。整個計劃仍在繼續，這就是擁有全額資助的計劃的好處。因此，我們現在所處的位置是，在很短的時間內，我們將在 24 年啟動我們認為需要在 25 年宣讀的所有內容，如果積極的話，將在 20 年初支持我們的 NDA '26 為Fasedienol 。所以，是的，無論兩項研究都絕對 100% 完成。

Thank you again.

再次感謝您。

You bet.

你打賭。

Our next question will be coming from Myles Minter, William Blair.

我們的下一個問題將來自邁爾斯·明特、威廉·布萊爾。

Hey, everyone. Thanks for taking the questions. I've got three if I may so bear with me. The first one is just on, I think previously you've guided towards submitting the Phase 2B protocol and MDD by year end. Are we still on track for that or is that slightly, maybe looking into next year.

嘿，大家。感謝您提出問題。如果可以的話，我有三個。第一個剛開始，我想您之前已經指導在年底之前提交 2B 階段協議和 MDD。我們是否仍在朝著這個目標邁進，或者是稍微有點，也許會考慮明年。

Second one is in that particular MDD study, have you thought about whether like a, maybe a caregiver or a physician would be administering the drug versus self-administration as I know that's a consideration between PAL 3 and PAL 4 or are you just relying on the fact that multiple doses in that trial probably net that exposure out.

第二個是在那個特定的 MDD 研究中，您是否考慮過是否像護理人員或醫生一樣服用藥物還是自行服用，因為我知道這是 PAL 3 和 PAL 4 之間的考慮因素，或者您只是依賴事實上，該試驗中的多次劑量可能會消除這種暴露。

And then finally, I'm wondering in the healthy subject data that you just presented at [NEI] on the depolarization of the electrograms there. Did you actually do dosing self-administering or a combination of self-administering versus physician administered to show that there was actually differences in those electrograms and the exposure of the drug. I know there's a lot there but would appreciate any thoughts. Thanks. Sure.

最後，我想知道您剛剛在 [NEI] 上提供的健康受試者數據中關於電圖去極化的情況。您實際上是否進行了自我給藥或自我給藥與醫生給藥的組合給藥，以顯示這些電圖和藥物暴露實際上存在差異。我知道那裡有很多東西，但我會很感激任何想法。謝謝。當然。

I appreciate the questions, Myles. So as to the first one and we're working very closely with our [Kols] and our internal team for that, the Phase 2B protocol, it still is the intention and we're well down the road with it. We got some pretty key thoughts already under our belt as to how we want to see that study proceed. A lot of it simply based on what we saw in on the Phase 2A study and what we think are the unique attributes of itruvone in MDD and especially as it relates to the folks with anxious depression.

我很感激這些問題，邁爾斯。對於第一個階段，我們正在與我們的 [Kols] 和我們的內部團隊密切合作，即 2B 階段協議，這仍然是我們的意圖，而且我們正在順利實施。關於我們希望如何進行這項研究，我們已經有了一些非常關鍵的想法。其中許多只是基於我們在 2A 期研究中看到的內容以及我們認為伊曲酮在 MDD 中的獨特屬性，特別是因為它與患有焦慮抑鬱症的人有關。

So I think that is a target we likely will hit. If not, it'll just creep maybe a little bit into January. But I think right now we've had a very substantial bit of discussions across all the folks that we want to provide some input, and that protocol is well down the road. So, in terms of self-administration during the study, we don't see that this is different. This is likely to be a six-week study with twice daily administration. So, on an outpatient basis by the folks, so they'll be self-administering it on an outpatient basis. And then as to the last question, Josh, I'll let you jump on that one.

所以我認為這是我們可能會實現的目標。如果沒有，它可能會慢慢地進入一月。但我認為現在我們已經與所有想要提供一些意見的人進行了非常實質性的討論，並且該協議正在順利實施中。因此，就研究期間的自我管理而言，我們沒有看到這有什麼不同。這可能是一項為期六週的研究，每天給藥兩次。因此，由人們在門診進行，因此他們將在門診進行自我管理。至於最後一個問題，喬什，我會讓你直接回答這個問題。

Sure. Yeah, the studies that we do in the lab with Doctor Monti kind of our, the inventor of pherine there --they're based on physician administration, and they really have to be because of the equipment that people are hooked up to. And so, sensors on the frontal lobe or receptors kind of in the nasal cavity. Those are those things require a lot of precision to do the measurements and to reduce noise in those capture of data. And so it's for that reason, it has to be physician administered.

當然。是的，我們與蒙蒂醫生（費林的發明者）在實驗室進行的研究——它們是基於醫生管理，而且確實必須是因為人們所連接的設備。因此，額葉上的感測器或鼻腔中的受體。這些事情需要很高的精度來進行測量並減少數據捕獲中的雜訊。因此，出於這個原因，它必須由醫生管理。

Those studies are conducted here in our headquarters in South San Francisco in our and so the subjects are laying down and the electrodes are placed inside and on up by the bridge of their nose, right where the factory bulbs are. So, they, as Josh noted, they're very sensitive and you have to, it's the best way to do it is just to have the IP administered by Dr. Monti and the team.

這些研究是在我們位於南舊金山的總部進行的，因此受試者躺著，電極放置在他們鼻樑的內部和上方，就在工廠燈泡所在的位置。因此，正如喬許所指出的那樣，他們非常敏感，你必須這樣做，最好的方法就是讓蒙蒂博士和團隊管理智慧財產權。

Makes a ton of sense. Thanks for the questions. Congrats on the progress.

很有道理。感謝您的提問。祝賀取得的進展。

Thanks.

謝謝。

(Operator Instructions)

（操作員說明）

Our last question for today will be coming from Madison Elsaadi, B. Riley Securities.

我們今天的最後一個問題將來自 B. Riley Securities 的 Madison Elsaadi。

Hey guys, congrats on all the progress and I appreciate you taking my question. I guess could you remind us what's gating to the hot flash study as well as a bit of a follow up to the prior question? What's really gating to that Phase 2B?

嘿夥計們，祝賀所有的進展，感謝您回答我的問題。我想你能提醒我們潮熱研究的門控是什麼以及對前一個問題的一些後續嗎？進入 2B 階段的真正原因是什麼？

And then, secondly, I know it's in the [pr] you mentioned an increase in head count. So, I was just wondering if this was just kind of related to general activities, across the enterprise or that was more related to one specific program? Thanks

其次，我知道你在[pr]中提到了人員數量的增加。所以，我只是想知道這是否只是與整個企業的一般活動相關，還是與一個特定計劃更相關？謝謝

Great. Thanks for the questions. Really appreciate it. So, a couple of things, so as to the gating for the PH80 study and vassal motor symptoms or hot flashes due to menopause. What we're doing now is the US IND enabling program. So, to bring that study, the initial study was done in Mexico and to bring the program into the United States, we're doing just the typical requisite nonclinical studies, CMC related studies, talk studies that bridge some of the older work.

偉大的。感謝您的提問。真的很感激。因此，有幾件事涉及 PH80 研究的門控以及更年期引起的血管運動症狀或潮熱。我們現在正在做的是美國IND授權計畫。因此，為了進行這項研究，最初的研究是在墨西哥進行的，為了將該計畫引入美國，我們正在做典型的必要非臨床研究、CMC 相關研究、連接一些舊工作的談話研究。

And then of course, the CMC because we had to make an entirely new supply of PH80 for the clinical program. So that's what's in motion in order to put us in a position to then submit an IND that would leap us right back into Phase 2 development in the US. So, phase likely for Phase 2 development, and, but just in hot flashes, we have positive data in PMDD.

當然，還有 CMC，因為我們必須為臨床項目生產全新的 PH80。這就是我們正在採取的行動，以便我們能夠提交 IND，從而使我們立即回到美國的第二階段開發。因此，第二階段的開發可能會進入階段，但只是在潮熱時期，我們在 PMDD 方面有正面的數據。

But hot flashes is the main direction given what we see is the tremendous opportunity that really nothing that we see that is non systemic and what's hormone free. The [NK three antagonists] do have some limitations so that CMC work non clinical work puts the regulatory package in place and that should be sometime in the second-quarter, I think is our target for that at this point.

但潮熱是主要方向，因為我們看到的是巨大的機會，我們看到的實際上沒有什麼是非系統性的、不含激素的。[NK 三種拮抗劑]確實有一些局限性，因此 CMC 工作非臨床工作將監管方案落實到位，這應該是在第二季度的某個時候，我認為這是我們目前的目標。

And then as to the MDD study in finalizing the protocol is really what's left there and then we have an ID that's already open, we've got Phase 1 support for the supply that we built that we produced. And again, with these, when we acquired these, we had to really go back to the beginning and do the CMC work necessary to enable the clinical work and the regulatory packages.

至於最終確定協議的 MDD 研究實際上是剩下的，然後我們有一個已經開放的 ID，我們為我們建造的、我們生產的供應提供了第一階段支援。再次，有了這些，當我們獲得這些時，我們必須真正回到起點，做必要的 CMC 工作，以實現臨床工作和監管包。

So all those boxes have been checked, and so I think we're on the final lap of the preparations up front of the MDD study and then head count wise, we're about 50 right now, and as you can imagine, as we have expanded clinical work and we've got a little bit of additional G&A support that's needed, but most of its R&D related a lot of it relates to owning, especially the surveillance and the training that's associated with the Phase 3 program trying to decouple some of that reliance that was a little bit more variable than we wanted to see during the pandemic.

所以所有這些框都已經檢查過了，所以我認為我們正處於 MDD 研究之前準備工作的最後一圈，然後從人數上看，我們現在大約有 50 人，正如你可以想像的，正如我們已經擴大了臨床工作，我們已經獲得了一些需要的額外一般管理支持，但其大部分研發都與擁有相關，尤其是與試圖將一些問題脫鉤的第三階段計劃相關的監視和培訓這種依賴的變化比我們在大流行期間希望看到的要多一些。

So that allows us to really have incompetence and own consistent surveillance, especially for the PALISADE Phase 3 program and of course, other things related to some of the pre commercial activities on the CMC side, especially. So a little bit in head count on the G&A side on finance, but for the most part, it's an R&D increase that's enabling us to do quite a bit more across each of the lead development programs that we've got.

因此，這讓我們確實無能並擁有持續的監視，特別是對於 PALISADE 第三階段計劃，當然還有與 CMC 方面的一些預商業活動相關的其他事情。因此，財務方面的總務管理方面的人員數量有所增加，但在大多數情況下，研發的增加使我們能夠在我們現有的每個領先開發項目中做更多的事情。

Got it very helpful. Thanks.

得到它非常有幫助。謝謝。

Operator. I believe that's all the time we have for questions today. Thank you, everyone. At this time, if you have any additional questions, please do not hesitate to contact us via e-mail at ir@vistagen or via the contact section of our website.

操作員。我相信我們今天的提問時間就到此為止。謝謝大家。此時，如果您有任何其他問題，請隨時透過電子郵件 ir@visagen 或透過我們網站的聯絡部分與我們聯繫。

We also encourage you to register email updates on our website to stay connected to the latest news again. Thank you for participating on the call today. We appreciate everyone's interest and support. We look forward to keeping everyone updated on our ongoing progress. This concludes our call. Have a great day.

我們也鼓勵您在我們的網站上註冊電子郵件更新，以便再次了解最新消息。感謝您參加今天的電話會議。我們感謝大家的關注與支持。我們期待讓大家了解我們的持續進展。我們的通話到此結束。祝你有美好的一天。

This concludes our conference call for today. We thank you for participating and ask that you please disconnect your lines. Have a great one. Everyone.

我們今天的電話會議到此結束。我們感謝您的參與，並請您斷開線路。祝你玩得開心。每個人。