Vistagen Therapeutics Inc (VTGN) 2023 Q4 法說會逐字稿

Greetings, and welcome to Vistagen Therapeutic's Fiscal Year End 2023 Corporate Update Conference Call. (Operator Instructions). As a reminder, this conference is being recorded.

您好，歡迎參加 Vistagen Therapeutic 的 2023 財年公司最新情況電話會議。 （操作員說明）。提醒一下，本次會議正在錄製中。

It is now my pleasure to introduce your host, Mark McPartland Senior Vice President of Investor Relations. Thank you. You may begin.

現在我很高興向您介紹主持人，投資者關係高級副總裁馬克·麥克帕特蘭 (Mark McPartland)。謝謝。你可以開始了。

Thank you, Doug. Good afternoon, everyone, and welcome to Vistagen's fiscal year-end 2023 corporate update conference call and webcast. This afternoon, we issued a press release providing an overview of our progress last year and future milestones, and we expect to file our fiscal year-end 10-K later this afternoon. We would encourage you to review both, which can be found under the Investors section of our website.

謝謝你，道格。大家下午好，歡迎參加 Vistagen 2023 財年公司更新電話會議和網絡廣播。今天下午，我們發布了一份新聞稿，概述了我們去年的進展和未來的里程碑，我們預計將在今天下午晚些時候提交我們的財年末 10-K。我們鼓勵您查看兩者，可以在我們網站的投資者部分找到。

Now before we start today's call, I want to remind you that we may make forward-looking statements regarding our business based on our current expectations and information. The forward-looking statements speak only as of today, and except as required by law, we do not assume any duty to update in the future any forward-looking statements made today. 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 the fiscal year-end 2023 Form 10-K, which, again, will be filed later today, which can also be found on our website or at the Securities and Exchange Commission website, sec.gov, and the future filings we make with the SEC from time to time, all of which will be available on our website and on the SEC website.

在我們開始今天的電話會議之前，我想提醒您，我們可能會根據我們當前的預期和信息對我們的業務做出前瞻性陳述。前瞻性陳述僅代表今天的情況，除非法律要求，否則我們不承擔任何責任在未來更新今天所做的任何前瞻性陳述。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做出的任何前瞻性陳述的預期存在重大差異。有關可能影響我們業務和財務業績的風險因素的更多信息包含在2023 財年終了的10-K 表格中，該表格將於今天晚些時候提交，也可以在我們的網站或證券和證券交易委員會上找到。交易委員會網站、sec.gov 以及我們未來不時向 SEC 提交的文件，所有這些都將在我們的網站和 SEC 網站上提供。

With that taken care of, I'd like to thank and welcome all of our stockholders, analysts and all of you taking an interest in Vistagen. I'm joined on the call today by Shawn Singh, our Chief Executive Officer. Shawn will provide an overview of the company's progress made in 2023, upcoming milestones, followed by a brief opportunity for questions from our sell-side analysts. We want to remind you again that this call is being webcast and recorded and will be available for replay. The replay link can be found in the Investors section of the website, vistagen.com.

考慮到這一點，我要感謝並歡迎我們所有的股東、分析師以及所有對 Vistagen 感興趣的人。我們的首席執行官肖恩·辛格 (Shawn Singh) 也參加了今天的電話會議。 Shawn 將概述公司在 2023 年取得的進展以及即將到來的里程碑，隨後我們的賣方分析師將有一個簡短的提問機會。我們想再次提醒您，本次電話會議正在進行網絡直播和錄音，並將可供重播。重播鏈接可以在網站 vistagen.com 的投資者部分找到。

Now with that done, I would like to turn the call over to Shawn Singh, our Chief Executive Officer. Shawn?

現在，完成此操作後，我想將電話轉給我們的首席執行官肖恩·辛格 (Shawn Singh)。肖恩？

Thank you, Mark, and good afternoon, everyone. Thank you for joining our call. As we've discussed many times, Vistagen's core mission is to radically improve the mental health and the well-being of the millions of individuals worldwide who suffer from a variety of anxiety, depression and other CNS disorders that severely disrupt their daily lives. To that end, each of our innovative clinical-stage CNS product candidates is designed with the potential to establish new standards of care, make meaningful differences in how patients manage their disorders and improve their lives.

謝謝你，馬克，大家下午好。感謝您加入我們的通話。正如我們多次討論的那樣，Vistagen 的核心使命是從根本上改善全球數百萬患有各種焦慮、抑鬱和其他嚴重擾亂日常生活的中樞神經系統疾病的人的心理健康和福祉。為此，我們每一個創新的臨床階段中樞神經系統候選產品的設計都有可能建立新的護理標準，對患者管理疾病和改善生活的方式產生有意義的影響。

Throughout the year, we continued to advance our core programs for treatment of social anxiety disorder with Fasedienol, major depressive disorder with Itruvone. We achieved multiple clinical and regulatory milestones that are necessary to stage what we see as key advances in those programs this year and beyond. We also advanced strategic planning for our other 4 clinical-stage product candidates, specifically PH80 for the treatment of menopausal hot flashes, which is a large and unsatisfied market.

在這一年裡，我們繼續推進我們的核心項目，用 Fasedienol 治療社交焦慮症，用 Itruvone 治療重度抑鬱症。我們實現了多個臨床和監管里程碑，這些里程碑是我們認為今年及以後這些項目取得關鍵進展所必需的。我們還為其他 4 個臨床階段候選產品推進了戰略規劃，特別是用於治療更年期潮熱的 PH80，這是一個巨大且不滿意的市場。

We are also advancing planning for further U.S. IND-enabling development to facilitate Phase IIb development of PH15 for rapid onset improvement of attention and learning in subjects with cognitive impairment that's caused by mental fatigue and of PH284 for enhancement of subjective feelings of appetite and weight gain in subjects with Cachexia or wasting syndrome that's associated with cancer or other disorders related to appetite loss.

我們還在推進進一步支持美國IND 的開發計劃，以促進PH15 的IIb 期開發，以快速改善因精神疲勞引起的認知障礙受試者的注意力和學習能力，以及PH284 的IIb 期開發，以增強食慾和體重增加的主觀感覺患有與癌症或其他與食慾不振相關的疾病相關的惡病質或消耗綜合症的受試者。

With the depth in our collective body of positive safety and efficacy studies supporting our clinical stage pipeline, now is the opportune time to amplify our internal efforts to secure multiple global and regional strategic development and commercialization partnerships across our entire portfolio to accelerate achievement of key clinical, regulatory and commercial milestones within each program, and deliver meaningful value to our stockholders and to the millions of patients who are affected by these disorders, affecting both their mental health and their physical well-being.

憑藉我們集體的積極安全性和有效性研究的深度支持我們的臨床階段管道，現在是時候加強我們的內部努力，以確保我們整個產品組合中的多個全球和區域戰略開發和商業化合作夥伴關係，以加速實現關鍵臨床每個項目中的監管和商業里程碑，並為我們的股東和數百萬受這些疾病影響的患者提供有意義的價值，影響他們的心理健康和身體健康。

I'll begin with a brief update on Fasedienol, formally called PH94B in our Phase III program in social anxiety disorder, or SAD. Earlier this year, we reported a long-term intranasal administration of 3.2 micrograms of Fasedienol self-administered by patients as they needed it up to 4 times a day to manage their anxiety provoking situations in a real-world setting was well tolerated with no new safety findings with trends identified regardless of the number of doses administered by each subject.

首先我將簡要介紹 Fasedienol，在我們的社交焦慮症 (SAD) III 期項目中，其正式名稱為 PH94B。今年早些時候，我們報導了患者自行長期鼻內給藥 3.2 微克 Fasedienol，因為他們需要每天最多 4 次來控制現實世界中引發焦慮的情況，這種情況得到了良好的耐受性，沒有新的無論每位受試者服用的劑量多少，都可以確定安全性結果和趨勢。

Overall, in that study, patients self-administered over 30,000 doses of Fasedienol with the main duration of 4 months in a maximum study duration of over 10 months. The exploratory efficacy results from that study demonstrated clinically meaningful reductions in fear, anxiety and avoidance of anxiety provoking social and performance situations in the daily lives of the patients involved as measured by the Liebowitz Social Anxiety Scale, or LSAS.

總體而言，在該研究中，患者自行服用了超過 30,000 劑 Fasedienol，主要持續時間為 4 個月，最長研究持續時間超過 10 個月。該研究的探索性療效結果表明，通過利博維茨社交焦慮量表（LSAS）測量，患者日常生活中的恐懼、焦慮和避免引起焦慮的社交和表現情況的減少具有臨床意義。

We believe the continued improvement in LSAS observed in hundreds of these SAD patients in this large study, including patients from both PALISADE 1 and PALISADE 2, indicates the therapeutic potential of multiple patient-tailored as needed administrations of Fasedienol over time, as Fasedienol helps patients build their confidence to engage in this anxiety provoking social situations in their daily lives more frequently and with less fear and anxiety.

我們相信，在這項大型研究中，數百名SAD 患者（包括來自PALISADE 1 和PALISADE 2 的患者）觀察到的LSAS 持續改善，表明隨著時間的推移，根據多個患者的需要量身定制Fasedienol的治療潛力，因為Fasedienol 可以幫助患者建立他們的信心，以便在日常生活中更頻繁地參與這種引發焦慮的社交場合，並減少恐懼和焦慮。

Further, the safety and exploratory results of the Phase III open label study of Fasedienol, along with the previous safety and LSAS efficacy results for multiple placebo-controlled Phase II studies, including a placebo-controlled study conducted in the real-world setting, build support for a meeting with the FDA to discuss the next steps in our FEARLESS Phase III development plan for Fasedienol in SAD.

此外，Fasedienol III 期開放標籤研究的安全性和探索性結果，以及之前多項安慰劑對照 II 期研究的安全性和 LSAS 療效結果，包括在現實環境中進行的安慰劑對照研究，構建了支持與FDA 召開會議，討論我們針對SAD 的Fasedienol 的FEARLESS III 期開發計劃的後續步驟。

The plan that is centered on the potential new drug application-enabling Phase III studies of Fasedienol in a real-world setting using the LSAS as the primary efficacy outcome measure in a manner similar to the registration studies for all 3 of the FDA-approved treatments for SAD.

該計劃的重點是在現實環境中使用 LSAS 作為主要療效結果衡量標準，以類似於 FDA 批准的所有 3 種療法的註冊研究的方式，對 Fasedienol 進行潛在的新藥申請 III 期研究對於悲傷。

Results from the placebo-controlled Phase III studies demonstrate that self-administration of Fasedienol on an as-needed basis prior to anxiety provoking situations has exciting potential to achieve fast-acting and persistent change in overall SAD symptoms, reduce fear and anxiety about social and performance situations and enable less frequent avoidance for those situations as measured by the LSAS.

安慰劑對照的 III 期研究結果表明，在引發焦慮的情況之前根據需要自行服用 Fasedienol 具有令人興奮的潛力，可以實現整體 SAD 症狀的快速和持久改變，減少對社交和社交的恐懼和焦慮。性能情況，並且可以減少LSAS 測量的情況下避免的頻率。

Notably, the amount of separation between Fasedienol and placebo as measured by the LSAS at the end of the first 2 weeks in the placebo-controlled Phase II study conducted in a real-world setting was comparable to LSAS results observed after 12 weeks in the registration trials for the 3 antidepressants approved by the FDA for the treatment of SAD.

值得注意的是，在現實環境中進行的安慰劑對照 II 期研究中，在前 2 週結束時通過 LSAS 測量的 Fasedienol 和安慰劑之間的分離量與註冊 12 週後觀察到的 LSAS 結果相當FDA批准的3 種抗抑鬱藥用於治療SAD 的試驗。

Positive feedback from the FDA earlier this year confirmed the acceptability of our preferred use of the LSAS as the primary efficacy endpoint in our future Phase III studies of Fasedienol for the treatment of SAD. Again, in line with all 3 of the previously approved SAD products. Our FEARLESS Phase III program in SAD will align with the LSAS-based study design, supporting the precedent-setting NDA-enabling programs for all 3 antidepressants currently approved for the treatment of SAD.

今年早些時候 FDA 的積極反饋證實了我們在未來 Fasedienol 治療 SAD 的 III 期研究中首選使用 LSAS 作為主要療效終點的可接受性。同樣，與之前批准的所有 3 種 SAD 產品一致。我們針對 SAD 的 FEARLESS III 期項目將與基於 LSAS 的研究設計保持一致，支持目前批准用於治療 SAD 的所有 3 種抗抑鬱藥物的開創先例的 NDA 項目。

The FEARLESS Phase III studies will be designed to assess multiple administrations of Fasedienol on a patient-tailored as-needed basis in their daily lives up to 6 times per day in a real-world outpatient setting over a multiple week period, with the clinician-administered LSAS as the primary efficacy endpoint.

FEARLESS III 期研究將旨在根據患者的日常生活需要，在現實世界的門診環境中，在多周的時間內，根據患者的需要，評估 Fasedienol 的多次給藥，每天最多 6 次，臨床醫生-施用LSAS 作為主要療效終點。

So with clarity from positive regulatory feedback on the path forward and the FDA's previous grant of Fast Track designation for development of Fasedienol for SAD, we're now positioned to finalize our full NDA-enabling FEARLESS Phase III development program for Fasedienol and plan for a large market program that is well suited for late-stage partnering to complete Phase III development and if successful, commercialize Fasedienol in the U.S. in multiple markets worldwide for a disorder that is increasingly impacting the lives of tens of millions of patients in the U.S. and around the world.

因此，根據對前進道路的積極監管反饋以及 FDA 之前授予 Fasedienol 治療 SAD 開發快速通道指定的明確信息，我們現在準備完成我們完整的 NDA 支持的 FEARLESS III 期 Fasedienol 開發計劃，併計劃大型市場計劃，非常適合後期合作以完成III 期開發，如果成功，將在美國在全球多個市場將Fasedienol 商業化，以治療日益影響美國及周邊地區數千萬患者生活的疾病世界。

Moving next to Itruvone, formally PH10, our pherine nasal spray candidate for potential rapid onset treatment of major depressive disorder, or MDD. We recently reported favorable safety and tolerability data from our U.S. Phase I clinical trial of Itruvone. Itruvone was well tolerated and consistently continued to demonstrate a favorable safety profile. Importantly, results from this study built on previous successful Phase I studies and a published positive placebo-controlled Phase IIa study of Itruvone in MDD that was conducted outside the U.S.

接下來是 Itruvone（正式名稱為 PH10），我們的 PH10 鼻噴霧劑候選藥物，用於潛在快速起效治療重度抑鬱症（MDD）。我們最近報告了 Itruvone 在美國 I 期臨床試驗的良好安全性和耐受性數據。 Itruvone 具有良好的耐受性，並持續表現出良好的安全性。重要的是，這項研究的結果建立在之前成功的 I 期研究和已發表的 Itruvone 治療 MDD 的陽性安慰劑對照 IIa 期研究的基礎上，該研究是在美國境外進行的。

So the collective body of successful clinical studies now enable us to focus on next step Phase IIb development of Itruvone in the U.S. as an innovative stand-alone rapid onset product candidate for the treatment of MDD. During the past year, the FDA also granted Fast Track designation for development of Itruvone for the treatment of MDD. So like Fasedienol for SAD, Itruvone is now staged for strategic partnering in the U.S. and multiple large depression markets outside the U.S.

因此，成功的臨床研究的集體現在使我們能夠專注於 Itruvone 在美國的下一步 IIb 期開發，作為治療 MDD 的創新的獨立快速起效候選產品。去年，FDA 還授予了 Itruvone 治療 MDD 開發的快速通道資格。因此，與治療 SAD 的 Fasedienol 一樣，Itruvone 目前正在美國和美國以外的多個大型抑鬱症市場開展戰略合作。

We also recently reported that PH80 demonstrated statistically significant efficacy versus placebo in a previously unreported exploratory Phase IIa clinical study for the treatment of vasomotor symptoms that are known as hot flashes that is due to menopause. In the study, PH80 induced a statistically significant reduction in the daily number of hot flashes compared to placebo at the end of the first week of treatment, and that improvement was maintained through the end of the 4-week treatment period.

我們最近還報告說，在一項先前未報告的探索性IIa 期臨床研究中，PH80 與安慰劑相比顯示出統計學上顯著的療效，用於治療更年期引起的血管舒縮症狀（即潮熱）。在該研究中，在治療第一周結束時，與安慰劑相比，PH80 導致每日潮熱次數出現統計顯著減少，並且這種改善一直持續到 4 周治療期結束。

PH80 treatment also significantly reduced the severity, disruption in function and sweating related to hot flashes during the treatment period as compared with placebo. As we've seen with all pherines in our pipeline, PH80 was well tolerated with no serious adverse events and an adverse event profile comparable to placebo in all of the clinical trials of that drug candidate to date. Prevalence of menopausal hot flashes is estimated to be about 20 million women in the U.S., with 9 million more women estimated to be suffering from severe hot flashes.

與安慰劑相比，PH80 治療還顯著降低了治療期間與潮熱相關的嚴重程度、功能破壞和出汗。正如我們在管道中的所有麻黃素中所看到的那樣，PH80 的耐受性良好，沒有發生嚴重的不良事件，並且在迄今為止該候選藥物的所有臨床試驗中，不良事件概況與安慰劑相當。據估計，美國約有 2000 萬女性患有更年期潮熱，估計還有 900 萬女性患有嚴重潮熱。

Current treatments are associated with certain side effects and significant safety concerns. So the pressing need for improved treatment options is evident when considering the millions of women who endure the disruptive impact of menopausal hot flashes in their daily lives. Also with its novel rapid onset mechanism of action, PH80 is designed to initiate neural impulses in the olfactory bulb transmitted by pathways that rapidly affect the function of multiple structures in the brain, including the amygdala and the hypothalamus.

目前的治療方法與某些副作用和重大安全問題有關。因此，考慮到數百萬在日常生活中遭受更年期潮熱破壞性影響的女性，顯然迫切需要改進治療方案。此外，憑藉其新穎的快速起效機制，PH80 旨在啟動嗅球中的神經衝動，這些神經衝動通過快速影響大腦多個結構（包括杏仁核和下丘腦）功能的途徑傳遞。

Due to its mechanism of action, we also believe PH80 has therapeutic potential to relieve premonitory and aura symptoms of migraine. We recently expanded the intellectual property portfolio of PH80 to include treatment of migraine, the U.S. patent issuance and an intention to grant the European patent. And we look forward to preparing for potential future development of PH15 and PH284 as well.

由於其作用機制，我們還相信 PH80 具有緩解偏頭痛的先兆和先兆症狀的治療潛力。我們最近擴大了 PH80 的知識產權組合，包括偏頭痛治療、美國專利授權以及授予歐洲專利的意向。我們也期待為 PH15 和 PH284 的未來潛在開發做好準備。

These are 2 pherine candidates that are also in Phase II development, and we're assessing a previously unreported exploratory Phase IIa studies, placebo-controlled Phase IIa studies, that involve PH15 for improvement of cognition, especially in sleep-deprived populations, and PH284 for improvement of subjective feeling of hunger in late-stage cancer patients, in particular, those with cachexia.

這2 種pherine 候選藥物也處於II 期開發階段，我們正在評估一項先前未報告的探索性IIa 期研究，即安慰劑對照IIa 期研究，其中涉及PH15 用於改善認知（尤其是在睡眠不足的人群中）和PH284改善晚期癌症患者，特別是惡病質患者的主觀飢餓感。

As to AV-101, our oral NMDA receptor antagonist, based on observations and findings from several preclinical studies and successful Phase I studies, we believe AV-101 has potential to become a new oral treatment alternative for certain CNS indications that involve the NMDA receptor. Recently, we strengthened our AV-101 intellectual property portfolio after receiving a new patent granted by the European Patent Office that's related to the synthesis of AV-101 and certain chemical intermediaries.

至於我們的口服NMDA 受體拮抗劑AV-101，根據多項臨床前研究和成功的I 期研究的觀察和結果，我們相信AV-101 有潛力成為涉及NMDA 受體的某些CNS 適應症的新口服治療替代品。最近，在獲得歐洲專利局授予的一項與 AV-101 和某些化學中間體的合成相關的新專利後，我們加強了 AV-101 知識產權組合。

That enhances the attractiveness of AV-101 as a valuable asset for potential strategic development and commercialization partnerships. We are currently pursuing partnering and nondilutive grant opportunities for Phase IIa clinical development of AV-101 as a treatment for one or more of those neurological disorders involving the NMDA receptor. Likely with emphasis on dyskinesia associated with Parkinson's therapies.

這增強了 AV-101 作為潛在戰略開發和商業化合作夥伴的寶貴資產的吸引力。我們目前正在為 AV-101 的 IIa 期臨床開發尋求合作和非稀釋資助機會，作為治療一種或多種涉及 NMDA 受體的神經系統疾病的方法。可能強調與帕金森病治療相關的運動障礙。

We believe our robust CNS pipeline puts us in a place of scientific strength in the field. We have a broad range of positive clinical studies across multiple product candidates and multiple indications with potential for long-term value creation and meaningful impact on the treatment landscape for millions of individuals affected by anxiety, depression, hot flashes and several other large-market CNS disorders.

我們相信，我們強大的中樞神經系統管道使我們在該領域處於科學實力的地位。我們對多種候選產品和多種適應症進行了廣泛的積極臨床研究，這些研究具有創造長期價值的潛力，並對數百萬受焦慮、抑鬱、潮熱和其他幾種大市場中樞神經系統影響的個體的治療前景產生有意義的影響失調。

Moving to our business strategy. Earlier this month, our Board of Directors authorized the stockholder-approved reverse split of our common stock. Our primary corporate and strategic objectives for implementing that stockholder-approved reverse split, included the following: First and foremost, we implemented the reverse split through established compliance with NASDAQ's minimum bid price requirement to help ensure that we maintain the numerous benefits of listing our common stock on the Nasdaq Capital Market. We recently announced regaining full compliance with the continued listing standards of the Nasdaq Capital Market. So together with our stockholders, we achieved that objective.

轉向我們的業務戰略。本月早些時候，我們的董事會授權對我們的普通股進行股東批准的反向分割。我們實施股東批准的反向分拆的主要企業和戰略目標包括以下內容：首先，我們通過遵守納斯達克的最低買入價要求來實施反向分拆，以幫助確保我們保持上市普通股的眾多好處。股票在納斯達克資本市場上市。我們最近宣布重新完全遵守納斯達克資本市場的持續上市標準。因此，我們與股東一起實現了這一目標。

Second, the reverse split enables us to increase awareness of Vistagen and the therapeutic and market potential of our 6 clinical-stage drug candidates, both in the capital markets, among prospective strategic partners and among health care-focused media.

其次，反向拆分使我們能夠在資本市場、潛在戰略合作夥伴和以醫療保健為重點的媒體中提高對 Vistagen 以及我們 6 種臨床階段候選藥物的治療和市場潛力的認識。

And finally, the split may broaden our capital market base through enhanced access to institutional investors, mutual funds, family offices, general investing public and health care-focused sell-side research analysts, all are key components of our ongoing efforts to advance awareness, understanding and the potential value of our CNS pipeline with our key stakeholders.

最後，此次拆分可能會通過增加與機構投資者、共同基金、家族辦公室、一般投資公眾和以醫療保健為重點的賣方研究分析師的接觸來擴大我們的資本市場基礎，所有這些都是我們不斷努力提高認識的關鍵組成部分，與我們的主要利益相關者一起了解我們的 CNS 管道的潛在價值。

Given the depth of our CNS pipeline and the robust body of successful safety and efficacy studies achieved to date, we are now pursuing multiple strategic development and commercialization partnerships, both global and regional, to efficiently unlock the full value of our product candidate portfolio. We believe global and regional partnerships amplify our internal activities and can accelerate key development milestones and time lines and enhance overall our ongoing efforts to deliver differentiated treatment options and significant value to our stockholders.

鑑於我們中樞神經系統管道的深度以及迄今為止所取得的成功的安全性和有效性研究的穩健性，我們現在正在尋求全球和區域的多個戰略開發和商業化合作夥伴關係，以有效地釋放我們候選產品組合的全部價值。我們相信，全球和區域合作夥伴關係可以擴大我們的內部活動，並可以加快關鍵發展里程碑和時間表的速度，並加強我們為股東提供差異化​​治療方案和重大價值的持續努力。

In closing, we remain unwavering in our core mission to improve mental health and well-being worldwide. As we continue advancing the next stages of our corporate development, we move forward with a strong team, a strong pipeline and a strong purpose that drives us to innovate better solutions for CNS disorders in large markets with significant unmet needs. On behalf of our entire business and team, thank you for the privilege and for the opportunity to make a difference, One Mind at a Time.

最後，我們堅定不移地履行改善全世界心理健康和福祉的核心使命。隨著我們繼續推進企業發展的下一階段，我們憑藉強大的團隊、強大的產品線和堅定的目標不斷前進，推動我們在需求未得到滿足的大型市場中為中樞神經系統疾病創新更好的解決方案。我謹代表我們整個企業和團隊，感謝您給予我們的榮幸和機會，讓我們有機會做出改變，一次一心。

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

謝謝你，肖恩。運營商，我們現在想開始向參加今天電話會議的賣方分析師提問。

Our first question comes from the line of Jason McCarthy with Maxim Group.

我們的第一個問題來自 Jason McCarthy 與 Maxim Group 的聯繫。

It sounds like you've made a tremendous amount of progress this year so far and looking forward to what comes next. But Shawn, can you explain a bit further why you think the multiple dose assessment real-world study design with the LSAS as the primary endpoint is a better approach than the single dose assessment public speaking challenge with SUDS as the primary. I know you touched on it a little bit earlier, if you can just elaborate a bit further and why your confident in the new Phase III study designed.

聽起來今年到目前為止你已經取得了巨大的進步，並且期待接下來會發生什麼。但是 Shawn，您能否進一步解釋一下為什麼您認為以 LSAS 作為主要終點的多劑量評估現實世界研究設計比以 SUDS 作為主要終點的單劑量評估公開演講挑戰更好。我知道您早些時候談到過這一點，如果您能進一步闡述一下，以及為什麼您對新設計的第三階段研究充滿信心。

Sure. Thanks, Jason. Great to talk to you. Well, as you know, Dr. Liebowitz is -- Dr. Michael Liebowitz is the innovator of the LSAS and the clinical investigator who was involved in the registration trials for the 3 approved drugs for the treatment of SAD and the published placebo-controlled Phase II studies of Fasedienol and SAD. And he will be the principal investigator in our FEARLESS Phase III program. So that matters.

當然。謝謝，傑森。很高興與你交談。嗯，正如你所知，Liebowitz 博士是——Michael Liebowitz 博士是 LSAS 的創新者，也是臨床研究者，參與了 3 種批准的治療 SAD 的藥物的註冊試驗以及已發表的安慰劑對照階段Fasedienol 和SAD的II 研究。他將成為我們 FEARLESS III 期項目的首席研究員。所以這很重要。

His prior experience, not just with Fasedienol, but obviously with the LSAS over the last 50 years is incredibly important. And we have developed with him a proprietary multistep LSAS training program that all the potential sites have to pass to his and to our satisfaction before they can be included in the FEARLESS study. So those are key advantages unique to our Phase III program. But the LSAS, it measures the overall improvement in disease severity by measuring both reduction in fear and anxiety over time about social situations, but also the reduction in avoidance of those anxiety provoking situations.

他之前的經驗，不僅是在 Fasedienol 方面的經驗，而且顯然在過去 50 年裡在 LSAS 方面的經驗也非常重要。我們與他一起開發了一個專有的多步驟 LSAS 培訓計劃，所有潛在地點都必須經過他和我們的滿意之後才能納入 FEARLESS 研究。因此，這些是我們第三階段項目獨特的關鍵優勢。但 LSAS 衡量疾病嚴重程度的總體改善情況是通過測量隨著時間的推移對社交情境的恐懼和焦慮的減少程度，以及避免那些引發焦慮的情況的減少程度。

So you're looking at patient-related dynamics over time over multiple administrations, whereas in the public speaking challenge with the SUDS, that was a single dose in a single anxiety provoking situation in the public speech. So we and Dr. Liebowitz and all the KOLs that we lean into believe the LSAS is by far the most appropriate endpoint to measure the efficacy potential of Fasedienol and really any other potential treatments for SAD because it reflects the true impact of the treatment on the patient's daily lives over time in a real-world setting.

因此，您正在研究多次給藥期間與患者相關的動態，而在 SUDS 的公開演講挑戰中，這是公開演講中單一焦慮引發情況下的單劑量。因此，我們和 Liebowitz 博士以及我們所信賴的所有 KOL 相信，LSAS 是迄今為止衡量 Fasedienol 以及任何其他潛在的 SAD 潛在治療方法的療效潛力的最合適終點，因為它反映了治療對 SAD 的真實影響。患者在現實世界環境中隨時間推移的日常生活。

And again, using LSAS is the primary endpoint in our FEARLESS Phase III program is consistent with the design of all the registration trials that supported the FDA's precedent-setting approvals for treatments of SAD. So we met with the FDA in the first quarter because when we met with the FDA in '20, it wasn't possible because of COVID-related restrictions and the world being sheltered in place, it really wasn't possible to do the precedent-based real-world LSAS-driven Phase III study.

再次強調，使用 LSAS 是我們 FEARLESS III 期項目的主要終點，這與支持 FDA 開創先例批准 SAD 治療的所有註冊試驗的設計是一致的。因此，我們在第一季度與FDA 會面，因為當我們在20 年與FDA 會面時，這是不可能的，因為與新冠病毒相關的限制以及世界都在適當的地方進行庇護，確實不可能再做先例基於現實世界的 LSAS 驅動的 III 期研究。

We could, however, as we all know, we did do the clinic-based public speaking challenge using the SUDS, which is a different endpoint that hasn't supported any prior approvals but at the time, that was the type of study that could be done. And it was okay to do, obviously, because we had a highly static Phase II study. I think what we didn't all understand at the time was and nor did many others, the impact of COVID might have brought to bear on executing studies like that and on the patients involved in the studies.

然而，眾所周知，我們確實可以使用 SUDS 進行基於臨床的公開演講挑戰，這是一個不同的終點，沒有支持任何先前的批准，但在當時，這是可以的研究類型做完了。顯然，這樣做是可以的，因為我們進行了高度靜態的二期研究。我認為我們當時以及許多其他人都不明白的是，新冠病毒的影響可能會對執行此類研究以及參與研究的患者產生影響。

But we met with the FDA mainly, and this was in the first quarter of this year to confirm that the LSAS, even though a drug hasn't been approved for SAD for 20 years, that the LSAS remains a valid and a reliable primary efficacy endpoint for potential NDA-enabling Phase III studies of Fasedienol in SAD. A very important point when we're discussing prospective partnering arrangements for potential support and commercialization through Phase III and beyond with prospective partners, we need to know what the FDA thinks and what the FDA regards as the go-to endpoint for treatments for SAD.

但我們主要是在今年第一季度與 FDA 會面，以確認 LSAS，儘管已有 20 年沒有批准用於 SAD 的藥物，但 LSAS 仍然是有效且可靠的主要療效Fasedienol 在SAD 中的潛在NDA 授權III 期研究的終點。當我們與潛在合作夥伴討論 III 期及以後的潛在支持和商業化的潛在合作安排時，非常重要的一點是，我們需要了解 FDA 的想法以及 FDA 認為什麼是 SAD 治療的首選終點。

So as we reported, we were very encouraged by those discussions with the FDA and again, because the LSAS captures effects over time, the ability for subjects to build confidence, build resilience and show through the administration of that clinician-administered scale that they're fearing things less and they're avoiding things less often.

因此，正如我們所報導的，我們對與FDA 的討論感到非常鼓舞，因為LSAS 捕捉到了隨著時間的推移所產生的影響，受試者建立信心、增強復原力的能力，並通過臨床醫生管理的量表的管理表明他們的能力。他們更少害怕事情，也更少避免事情。

Great. And can you I guess, help everybody understand, you used a great analogy for Fasedienol as like a rescue inhaler would be used for asthma. I think that really helps people understand how this drug can work in the real-world setting. Can you just talk a little bit about that?

偉大的。我猜你能幫助大家理解嗎，你對 Fasedienol 使用了一個很好的類比，就像救援吸入器用於治療哮喘一樣。我認為這確實有助於人們了解這種藥物如何在現實世界中發揮作用。你能簡單談談這個嗎？

Yes, I'm glad you brought that up. It is -- it's really important to give patients control. Because sometimes the stressors are predictable, sometimes they're not. But regardless, what they need is something at hand that they can decide when they need to use it can knock down the symptoms of anxiety that arise in the context of those situations.

是的，我很高興你提出這個問題。給予患者控制權非常重要。因為有時壓力源是可以預測的，有時則不然。但無論如何，他們需要的是手頭的東西，他們可以決定何時需要使用它，可以消除在這些情況下出現的焦慮症狀。

And so it's a drug candidate that we've long held needs to be used acutely to knock down situations when they arise but also over time, similar to cognitive behavioral therapy, where consistent success when exposed to those stressors build the confidence, build the resilience to engage in those situations more frequently and then to do so with less fear and anxiety.

因此，我們長期以來一直認為，這是一種候選藥物，需要在情況出現時迅速加以利用，而且隨著時間的推移，這種情況也需要消除，類似於認知行為療法，在暴露於這些壓力源時持續取得成功，可以建立信心，建立復原力更頻繁地參與這些情況，然後減少恐懼和焦慮。

So it's very important, again, to be able to use our drug candidate multiple times in any given day, and some days not have to use it because when you are an SAD patient, if you're not exposed to your stressors, you're asymptomatic. You don't really want to put drugs in their body, even super safe drugs, when they think -- when they don't think they need it.

因此，能夠在任何一天多次使用我們的候選藥物是非常重要的，有些日子不必使用它，因為當您是 SAD 患者時，如果您沒有暴露於壓力源，您就會再次無症狀。當他們認為不需要藥物時，你真的不想將藥物放入他們的體內，即使是超級安全的藥物。

In the case of Fasedienol, having that drug in your pocket, in your purse, in your backpack, and being able to have something with onset in about 15 minutes, help you through that stressful situation. And having that duration of that effect last about an hour, to be able to go back to it if the same situation arises or a different situation arises within the same day.

就 Fasedienol 而言，將這種藥物放在您的口袋、錢包、背包中，並且能夠在大約 15 分鐘內服用一些起效的藥物，可以幫助您度過這種緊張的情況。並且該效果的持續時間大約為一個小時，以便在同一天出現相同情況或不同情況時能夠返回到該效果。

It's a very important flexible tool, again, all intended to build the confidence of the patient over time, which is exactly what the LSAS captures. And you can't capture that as well at all with the SUDS because that's -- again, that's just in the moment, minute-by-minute assessment of that acute effect. Now, again, use it -- using it acutely over time is the way we see this drug will be used if approved in the real-world setting by millions of people who have access to it and in need because of the way their lives are impacted by SAD.

再次強調，這是一個非常重要的靈活工具，所有這些都是為了隨著時間的推移建立患者的信心，這正是 LSAS 所捕捉到的。你根本無法用 SUDS 捕捉到這一點，因為這只是在當下，對這種急性效應的每分鐘評估。現在，再次使用它——隨著時間的推移，我們看到這種藥物將得到使用，如果數以百萬計的人能夠獲得這種藥物，並且由於他們的生活方式而有需要，那麼我們將看到這種藥物的使用方式。受到SAD的影響。

Our next question comes from the line of Andrew Tsai with Jefferies.

我們的下一個問題來自安德魯·蔡 (Andrew Tsai) 與杰弗里斯 (Jefferies) 的對話。

Appreciate the update. So the first question is on the FEARLESS program actually. So now you've met with the FDA, you're ready to kind of start up the studies. When exactly could those studies start specifically? And then for PALISADE 1 and 2, the prior studies, are there plans to share detailed data on either or both of those studies?

感謝更新。所以第一個問題實際上是關於 FEARLESS 計劃的。現在您已經與 FDA 會面了，您已經準備好開始研究了。這些研究具體什麼時候可以開始？那麼對於 PALISADE 1 和 2（之前的研究），是否有計劃分享其中一項或兩項研究的詳細數據？

Andrew, thanks. So it depends, right? So fortunately, these are not really expensive studies. Each of them is about $15 million. And right now, the cost to get the program all the way through to an NDA, relatively speaking, is actually pretty modest for a Phase III candidate. So what that does is it puts out in front of us what we see is a lot of opportunities for Phase III development in collaboration with capable partners in the space, either globally or multiple regional deals, that have commercial capabilities that we think can optimize the commercial potential of the drug as well.

安德魯，謝謝。所以這要看情況，對吧？幸運的是，這些研究並不是非常昂貴。每人約1500萬美元。目前，相對而言，對於第三階段候選者來說，從該項目一直到 NDA 的成本實際上相當適中。因此，它的作用是，它向我們展示了與該領域有能力的合作夥伴合作進行第三階段開發的大量機會，無論是全球性的還是多個區域性的交易，這些合作夥伴擁有我們認為可以優化的商業能力。該藥物的商業潛力也是如此。

So it will depend. It depends on technically we can be in as early as the first quarter of '24. We'll see how things go in terms of the types of financing arrangements or partnering arrangements more likely that we can put together in order to underwrite that program. So the important piece that moved things forward that was very critical was to make sure we had the kind of clarity and confidence from the agency that the LSAS was still and is still the go-to valid and reliable endpoint for a Phase III program.

所以這要看情況。這取決於技術上我們最早可以在 24 年第一季度實現。我們將看看融資安排或合作安排的類型如何發展，我們更有可能將這些安排或合作安排放在一起以承保該計劃。因此，推動事情向前發展的重要一步是確保我們從該機構獲得明確和信心，即 LSAS 仍然是第三階段計劃的有效和可靠的終點。

And again, because now COVID's not controlling anyone's lives anywhere near the degree was the case during the PALISADE studies, it's, in large part, during the acute phase of the pandemic, that clarity is in hand. So we are -- as you might expect, we're on a lot of radars, and no one has any trouble figuring out what drugs are in Phase III that are associated with large CNS markets. So we'll continue to advance on that.

再說一次，因為現在新冠病毒對任何人的生活的控製程度都遠不及 PALISADE 研究期間的情況，所以在很大程度上，在大流行的急性階段，情況已經明朗了。所以，正如您所預料的那樣，我們受到了很多關注，沒有人能夠輕鬆地弄清楚哪些藥物處於第三階段，與大型中樞神經系統市場相關。因此，我們將繼續在這方面取得進展。

In terms of PALISADE-1, PALISADE-2, I think what we see downstream is when we have a context to put both of those studies together, and we have the ability to understand some of the impacts that really affected a lot of companies, not just us, in terms of pandemic-related impacts, not only on just staffing and surveillance, but really even on the patients, the types of patients that were in studies. I'm sure you've heard this -- I know you've heard this from other sponsors. They seem to be just a bit different. There were cases, clearly, where people might have met the criteria for, say, SAD or the diagnostic criteria for SAD, for MDD, for other neuropsychiatric disorders during the pandemic, but may not really have had outside the context of a pandemic, the kind of long-term chronic pathophysiology associated with those disorders.

就 PALISADE-1、PALISADE-2 而言，我認為我們在下游看到的是，當我們有一個背景將這兩項研究放在一起時，我們有能力了解一些真正影響很多公司的影響，不僅僅是我們，就與大流行相關的影響而言，不僅對人員配備和監測，而且甚至對患者，即正在研究的患者類型。我相信你已經聽過這個——我知道你也從其他贊助商那裡聽說過這個。他們似乎只是有點不同。顯然，在某些情況下，人們可能在大流行期間符合 SAD 的標准或 SAD、MDD 和其他神經精神疾病的診斷標準，但在大流行的背景下可能並不真正符合。與這些疾病相關的長期慢性病理生理學。

So we'll see. But I think in terms of the 2 studies, yes, we'd like to put them together and the appropriate context. We'll be releasing the results of PALISADE-2 once we're in a position to do that sometime during the second half of this year. And when the 2 are together, we'd certainly want to put them in front of peers and into conference presentations at a minimum, if not a publication. So a lot of lessons learned from both of those studies. So a lot to be looked at, a lot to be assessed.

所以我們拭目以待。但我認為就這兩項研究而言，是的，我們希望將它們放在一起並提供適當的背景。一旦我們能夠在今年下半年的某個時候發布 PALISADE-2 的結果，我們就會發布該結果。當兩者結合在一起時，我們當然希望將它們放在同行面前並至少在會議上進行演示（如果不是出版物的話）。從這兩項研究中我們吸取了很多教訓。因此，有很多東西需要觀察，很多東西需要評估。

Great. And then shifting to your other pherines, PH10 for depression. Can you give us a brief update where this asset stands and the next steps? What would the next design of the next study look like, for instance?

偉大的。然後轉向你的其他 pherines，PH10 來治療抑鬱症。您能否向我們簡要介紹一下該資產的最新情況以及後續步驟？例如，下一項研究的下一個設計會是什麼樣子？

Yes. Great that you asked that. So Itruvone, we know there's nothing but a growing need for innovations in terms of treatment of depression, especially anything that can act on a stand-alone basis and even a relatively rapid onset manner, weeks, even better than months. And so what we needed to do with Itruvone was to get it back to the Phase IIb stage for U.S. development, either by us or in collaboration with a partner focused on depression, and with large market commercial capabilities.

是的。很高興你這麼問。因此，Itruvone，我們知道，在抑鬱症治療方面，除了對創新的需求不斷增長之外，什麼都沒有，特別是任何可以獨立發揮作用的藥物，甚至是相對快速的起效方式，幾週甚至幾個月的效果。因此，我們需要對 Itruvone 做的就是讓它回到美國的 IIb 期開發階段，無論是由我們自己還是與專注於抑鬱症且具有巨大市場商業能力的合作夥伴合作。

And now it's in that spot. And we had several successful studies that were conducted outside the U.S. We had to do U.S. IND-enabling studies to put it into a point where we could skip back over IIa and go right into Phase IIb. So like Fasedienol, we'll be aggressively pursuing strategic development and commercialization partnerships for that asset, not just in the U.S., but in multiple markets, and many of those dialogues are already ongoing. So ideal situation is we'd like to see sometime around the middle of next year the ability to get that back into U.S. clinical development, again, alone or with collaborators.

現在它就在那個地方。我們在美國境外進行了幾項成功的研究。我們必須在美國進行 IND 授權研究，以便我們可以跳過 IIa 階段並直接進入 IIb 階段。因此，與 Fasedienol 一樣，我們將積極尋求該資產的戰略開發和商業化合作夥伴關係，不僅在美國，而且在多個市場，其中許多對話已經在進行中。因此，理想的情況是我們希望在明年年中的某個時候能夠單獨或與合作者再次將其重新納入美國臨床開發。

Great. And then also can you -- go ahead.

偉大的。然後你也可以——繼續吧。

Sorry, I didn't answer the rest of the question, which is that study, again, we'll be developing it as a potentially rapid onset stand-alone treatment candidate for major depressive disorders. So more on the protocol, but basically, it's daily as opposed to as needed, and the study will likely be multiple weeks, 4 to 6 weeks.

抱歉，我沒有回答問題的其餘部分，即該研究，我們將再次將其開發為一種潛在的快速起效的獨立治療重度抑鬱症的候選藥物。關於方案的更多內容，但基本上是每天進行，而不是根據需要進行，並且研究可能會持續數週，4 到 6 週。

Got it. Got it. And then PH80 for menopausal hot flashes you announced some data. So what exactly did you see in the data to kind of make you excited about this asset? And I guess, again, what are the possible next steps from here?

知道了。知道了。然後PH80針對更年期潮熱你公佈了一些數據。那麼，您在數據中到底看到了什麼讓您對這項資產感到興奮呢？我再次猜測，接下來可能採取的步驟是什麼？

Yes. Again, that's a rapid-onset neuroactive pherine that's demonstrated positive Phase IIa results in reducing the frequency and the severity of hot flashes that are due to menopause. So right now, we're -- like every other asset in the pipeline, we're exploring opportunities to advance that program through Phase IIb and beyond in concert with multiple collaborators in multiple markets.

是的。同樣，這是一種快速起效的神經活性菲林，已被證明具有積極的 IIa 期結果，可以減少更年期引起的潮熱的頻率和嚴重程度。因此，現在，就像管道中的所有其他資產一樣，我們正在與多個市場的多個合作者合作，探索通過 IIb 期及以後推進該計劃的機會。

As you can imagine, I mean, there was an NK3 inhibitor that you saw recently approved by Astellas. So that one is systemic oral. We know there's safety issues concerned with that one. We don't see any of those attributes in the potential for PH80. And that is a space that has an incredible need and a lot of interest amongst companies focused on women's health. So we know that it's a large market. We know it's underserved. We know it's the most common symptom of menopausal transition.

你可以想像，我的意思是，你看到安斯泰來最近批准了一種 NK3 抑製劑。所以說這是系統性的口腔。我們知道這存在安全問題。我們在 PH80 的潛力中看不到任何這些屬性。這個領域有著令人難以置信的需求和關注女性健康的公司的濃厚興趣。所以我們知道這是一個很大的市場。我們知道它的服務不足。我們知道這是更年期過渡最常見的症狀。

It affects about 75% of menopausal women and about 40% of women in premenopause, so it's 20 million-or-so women in the U.S. and 9 million-or-so that suffer from severe hot flashes. So we will put this into a position where, again, like PH10 and Itruvone, it's a similar path. We do some IND-enabling work. We did get a U.S. IND in place, and we skip back over Phase II right into Phase IIb. And that Phase IIb program can be supportive then of our pathway into Phase III and then support and market it around the world if we get that benefit.

它影響了大約 75% 的更年期女性和大約 40% 的絕經前女性，因此美國有大約 2000 萬女性和大約 900 萬左右患有嚴重潮熱。因此，我們將把它放在一個位置上，就像 PH10 和 Itruvone 一樣，這是一條相似的路徑。我們做了一些 IND 支持工作。我們確實在美國獲得了 IND，並且我們跳過第二階段直接進入第二階段。 IIb 期計劃可以支持我們進入 III 期的道路，然後如果我們獲得這種好處，則可以在世界各地支持和營銷它。

Makes sense. And then you do have additional pherines, PH15 and 284 seems pretty attractive. So can you talk a little bit more about those 2 drugs and when they can get into the clinic? And are you also considering a partner for those assets as well?

說得通。然後你確實有額外的 pherine，PH15 和 284 似乎很有吸引力。那麼您能多談談這兩種藥物以及它們何時可以進入臨床嗎？您是否也在考慮為這些資產尋找合作夥伴？

Yes. And we're at a spot now where, especially after acquiring Pherin, we have not only the clinical-stage assets, 6 assets that are in clinical stage, and the capability or the potential to advance additional preclinical candidates into clinical development. So the Pherin platform is robust. And given the depth of the pipeline and the broad nature of the positive safety and efficacy studies we've got, every one of those assets can be supported by either internal development or collaborative development or really a combination of both. So those 2 assets in particular, PH15 and PH284, together and independently represent very large markets in cognition impairment for PH15 and subjective feelings of hunger and the like, especially in late-stage cancer patients with cachexia.

是的。我們現在所處的位置，特別是在收購 Pherin 之後，我們不僅擁有臨床階段資產（6 個處於臨床階段的資產），而且有能力或潛力將其他臨床前候選藥物推進臨床開發。因此，Pherin 平台非常強大。考慮到管道的深度以及我們所獲得的積極安全性和有效性研究的廣泛性，這些資產中的每一項都可以通過內部開發或協作開發或兩者的結合來支持。因此，這兩種資產，特別是 PH15 和 PH284，共同和獨立地代表了 PH15 的認知障礙和主觀飢餓感等方面的非常大的市場，特別是在患有惡病質的晚期癌症患者中。

So we'll be doing the same thing with those. Right now, we're assessing some of the data that we've got in the context of the acquisition of Pherin. Hopefully, we'll have more to say in the near term in terms of the Phase IIa data with those 2 programs, and then they would follow a similar path to what we have done with PH10, to move it into the U.S., and also, we'll be dealing with PH80 to move it into the U.S., and overall, ultimately, each of the U.S. dossier supports leverage in multiple markets outside the U.S.

所以我們將對這些做同樣的事情。目前，我們正在評估在收購 Pherin 的過程中獲得的一些數據。希望我們能在短期內對這兩個項目的 IIa 期數據有更多的說法，然後他們將遵循與我們對 PH10 所做的類似的路徑，將其轉移到美國，並且，我們將處理PH80，將其轉移到美國，總體而言，最終，每個美國檔案都支持美國以外多個市場的槓桿作用。

Operator, I believe that's all the time we have for questions today. If there's any additional questions, please don't hesitate to contact us by e-mailing ir@vistagen.com or contacting the individuals listed on the bottom of our press release. The information is also available on our website. We also encourage you to sign up our website to stay connected about news updates about Vistagen. Again, thank you for participating on the call today. We appreciate everyone's attention and support. We look forward to keeping you current on our continued progress. This concludes our call. Have a fantastic day.

接線員，我想我們今天的提問時間就到此為止了。如果還有任何其他問題，請隨時通過電子郵件 ir@visagen.com 或聯繫我們新聞稿底部列出的個人與我們聯繫。這些信息也可以在我們的網站上找到。我們還鼓勵您註冊我們的網站，以隨時了解有關 Vistagen 的新聞更新。再次感謝您參加今天的電話會議。我們感謝大家的關注和支持。我們期待讓您了解我們的持續進展。我們的通話到此結束。擁有美好的一天。

Ladies and gentlemen, this does conclude today's teleconference. Thank you for your participation. You may disconnect your lines at this time, and have a wonderful day.

女士們、先生們，今天的電話會議到此結束。感謝您的參與。此時您可以斷開線路，度過美好的一天。