Trevena Inc (TRVN) 2022 Q4 法說會逐字稿

Greetings, and welcome to the Trevena Fourth Quarter and Full Year 2022 Earnings Call. (Operator Instructions) As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Barry Shin, Chief Financial Officer for Trevena. Thank you. You may begin.

您好，歡迎來到 Trevena 第四季度和 2022 年全年收益電話會議。 （操作員說明）提醒一下，正在錄製此會議。我現在想把會議轉交給你的主持人，Trevena 的首席財務官 Barry Shin。謝謝。你可以開始了。

Great. Thanks. Good morning, and welcome, everyone. With me today are Carrie Bourdow, our President and CEO; Patty Drake, our Chief Commercial Officer; and our Chief Medical Officer, Mark Demitrack.

偉大的。謝謝。早上好，歡迎大家。今天和我在一起的是我們的總裁兼首席執行官 Carrie Bourdow； Patty Drake，我們的首席商務官；以及我們的首席醫療官 Mark Demitrack。

As a reminder, OLINVYK was approved by the FDA in August 2020 and contains oliceridine, an opioid, which is a schedule II controlled substance with a high potential for abuse similar to other opioids is indicated in adults for the management of acute pains fair enough to require an IV opioid analgesic entered from alternative treatments are inadequate.

提醒一下，OLINVYK 於 2020 年 8 月獲得 FDA 批准，其中含有阿片類藥物 oliceridine，這是一種附表 II 受控物質，與其他阿片類藥物類似，具有很高的濫用潛力，適用於成人治療急性疼痛，足以公平地需要從替代療法中輸入靜脈阿片類鎮痛藥是不夠的。

As with all opioids, serious life-threatening or fatal respiratory depression may occur in patients treated with OLINVYK as indicated in the boxed warning. Sedation is an established risk of opioids, including OLINVYK and is reflected in the OLINVYK label, nausea and vomiting were 2 of the most common adverse events reported in the control of clinical trials. The important safety information, including the box warning and full prescribing information are all available on OLINVYK.com.

與所有阿片類藥物一樣，如黑框警告所示，接受 OLINVYK 治療的患者可能會出現嚴重危及生命或致命的呼吸抑制。鎮靜是阿片類藥物的既定風險，包括 OLINVYK 並反映在 OLINVYK 標籤中，噁心和嘔吐是臨床試驗對照中報告的最常見不良事件中的兩種。重要的安全信息，包括盒子警告和完整的處方信息，都可以在 OLINVYK.com 上找到。

We'll also be making forward-looking statements under federal securities law. These statements are subject to risks and uncertainties related to our business, including those covered in our filings with the SEC. We undertake no obligation to update these statements beyond today.

我們還將根據聯邦證券法做出前瞻性陳述。這些聲明受與我們業務相關的風險和不確定性的影響，包括我們向美國證券交易委員會提交的文件中涵蓋的風險和不確定性。我們沒有義務在今天之後更新這些聲明。

I'll now turn the call over to Carrie for an overview of our fourth quarter and recent business accomplishments. Carrie?

我現在將電話轉給 Carrie，以概述我們的第四季度和最近的業務成就。嘉莉？

Thank you, Barry. Good morning, everyone, and thanks for joining. As you saw this morning, we announced exciting initial top line data for OLINVYK from VOLITION, the Cleveland clinic led real-world outcome study. We also analyzed electronic medical record data from Wake Forest, one of the VOLITION study sites.

謝謝你，巴里。大家早上好，感謝您的加入。正如您今天早上看到的那樣，我們宣布了 VOLITION 的 OLINVYK 令人興奮的初始頂線數據，克利夫蘭診所領導了現實世界的結果研究。我們還分析了維克森林大學的電子病歷數據，維克森林大學是 VOLITION 研究中心之一。

This morning, Mark will review top line GI and cognitive outcomes and length of stay from these studies. We anticipate reporting the remaining data sets, including the respiratory outcome data midyear when they're available. In our commercialization efforts, the hospital market remains challenging, and the continued focus is on managing costs. Hospitals are facing margin pressures due to a whole host of factors. And we see this playing out in delays from key stakeholders, including pharmacy and therapeutics committees.

今天早上，Mark 將回顧這些研究的頂級 GI 和認知結果以及住院時間。我們預計會在年中報告剩餘的數據集，包括呼吸結果數據。在我們的商業化努力中，醫院市場仍然充滿挑戰，並且繼續關注成本管理。由於一系列因素，醫院面臨著利潤壓力。我們看到這在主要利益相關者（包括藥房和治療委員會）的拖延中發揮了作用。

We are continuing to highlight OLINVYK a key pharmacy and physician meetings and appropriately positioning OLINVYK for complex patients in both the hospital inpatient and ambulatory surgical settings. You'll hear from Patty that we're seeing a clear shift to more procedures and more complex patients being treated in ASCs. Our efficient field sales team is engaging with top decision-makers in the ASC setting and the recently secured CMS pass-through status for OLINVYK has strengthened the reimbursement picture. Overall, we continue to focus our attention and resources on the best potential near-term and long-term growth areas for OLINVYK.

我們將繼續強調 OLINVYK 是一次重要的藥房和醫生會議，並在醫院住院和門診手術環境中為複雜患者適當定位 OLINVYK 。您會從 Patty 那裡聽到，我們正在明顯地轉向更多的程序和更複雜的患者在 ASC 中接受治療。我們高效的現場銷售團隊正在與 ASC 環境中的最高決策者進行接觸，最近獲得的 OLINVYK CMS 傳遞狀態加強了報銷情況。總體而言，我們繼續將注意力和資源集中在 OLINVYK 最具潛力的近期和長期增長領域。

Turning to our pipeline. We're very excited about the progress we're making with TRV045, our novel S1P receptor modulator. As a reminder, we're interested in 2 areas: non-opioid treatment of acute and chronic neuropathic pain secondary to diabetic peripheral neuropathy and epilepsy. We're underway with 2 proof-of-concept studies, a target engagement study and a TMS study looking at brain electrical activity. We're expecting to complete enrollment for both studies by midyear with top line data in the third quarter. We'll use the results of these studies to help further inform the path forward for TRV045.

轉向我們的管道。我們對我們的新型 S1P 受體調節劑 TRV045 取得的進展感到非常興奮。提醒一下，我們對 2 個領域感興趣：非阿片類藥物治療繼發於糖尿病周圍神經病變和癲癇的急性和慢性神經性疼痛。我們正在進行 2 項概念驗證研究、一項目標參與研究和一項關注腦電活動的 TMS 研究。我們預計將在年中完成這兩項研究的註冊，並在第三季度獲得頂線數據。我們將使用這些研究的結果來幫助進一步了解 TRV045 的前進道路。

In addition to the TRV045 data and OLINVYK commercialization, potential partnering discussions are ongoing, and our partner in China, Nhwa expects a regulatory decision on OLINVYK in the first half of this year. We have $38.3 million in cash and multiple upcoming milestones. Let me now turn the call over to Patty and Mark to provide more details on OLINVYK and TRV045. Patty?

除了 TRV045 數據和 OLINVYK 商業化，潛在的合作討論正在進行中，我們在中國的合作夥伴 Nhwa 預計今年上半年將對 OLINVYK 做出監管決定。我們有 3830 萬美元的現金和多個即將到來的里程碑。現在讓我將電話轉給 Patty 和 Mark，以提供有關 OLINVYK 和 TRV045 的更多詳細信息。帕蒂？

Thanks, Carrie, and good morning, everybody. Today, I'll provide you with a quarterly update on OLINVYK's performance relative to the market access and field execution parameters that we have discussed with you on previous calls. Let me start with an update on our contract with Vizient. A significant portion of our business continues to flow through Vizient. Their diverse membership and customer base includes academic medical centers, community hospitals and integrated health delivery networks. We believe there may be a long-term potential opportunity with Vizient, but we remind you that it takes time for these types of large GPO contracts to ramp up.

謝謝，嘉莉，大家早上好。今天，我將向您提供 OLINVYK 與我們在之前的電話會議上與您討論過的市場准入和現場執行參數相關的性能季度更新。讓我先從我們與 Vizient 的合同更新開始。我們業務的很大一部分繼續流經 Vizient。他們多元化的成員和客戶群包括學術醫療中心、社區醫院和綜合醫療服務網絡。我們相信 Vizient 可能有一個長期的潛在機會，但我們提醒您，這些類型的大型 GPO 合同需要時間來增加。

As Carrie mentioned, we've made progress in our recent initiatives to contract directly with national ambulatory surgical centers or ASC chains. This is important as there's a steady shift in the number of surgeries that are happening in ASCs and our field team continues to meet with top ASC providers.

正如 Carrie 提到的那樣，我們在最近與國家門診手術中心或 ASC 連鎖店直接簽約的舉措中取得了進展。這一點很重要，因為 ASC 中發生的手術數量在穩步變化，我們的現場團隊繼續與頂級 ASC 供應商會面。

We also signed 3 new specialty distributor agreements in the fourth quarter that are uniquely positioned to support the ambulatory surgical centers. There are several reasons for us to focus on the ASC setting at this time. There's a growing demand for multi-disciplined facilities in the U.S. Patients are seeking outpatient care because ASC costs are generally lower than equivalent treatment in the inpatient hospital setting.

我們還在第四季度簽署了 3 份新的專業分銷商協議，這些協議具有獨特的優勢，可以支持門診手術中心。我們此時關注 ASC 設置有幾個原因。美國對多學科設施的需求不斷增長。患者正在尋求門診治療，因為 ASC 成本通常低於住院醫院環境中的同等治療。

ASCs are conducting more complex procedures. And as a result, there are 7 states that are now allowing for longer than 24-hour stays in these facilities. Access to the surgeons and anesthesiologists is more readily available in this setting and decision-making regarding adding new therapies is far more streamlined. The surgeons can then leverage that experience into future formulary decisions within the hospital setting.

ASC 正在執行更複雜的程序。因此，現在有 7 個州允許在這些設施中停留超過 24 小時。在這種情況下更容易接觸到外科醫生和麻醉師，並且關於添加新療法的決策制定也更加簡化。然後，外科醫生可以利用這些經驗在醫院環境中進行未來的處方決策。

Lastly, another potential tailwind for the ASC market is the CMS pass-through designation that OLINVYK received last fall. Given our focus on the ASC opportunity, our top-down contracting efforts, we took measures earlier this year to find an even more efficient deployment of our sales force team focusing on pulling through the contracts we now have in place. With 184 formulary wins so far, we remain actively engaged in in-service programs, training on the use of OLINVYK as well as congresses and speaker programs.

最後，ASC 市場的另一個潛在順風是 OLINVYK 去年秋天獲得的 CMS 直通指定。鑑於我們專注於 ASC 機會，我們自上而下的合同工作，我們在今年早些時候採取了措施，以更有效地部署我們的銷售團隊，專注於完成我們現在簽訂的合同。到目前為止，我們已經贏得了 184 項處方藥，我們仍然積極參與在職計劃、使用 OLINVYK 的培訓以及大會和演講計劃。

While the base remains very small, the number of cartons per order is increasing as is the reorder rate, which is indicative that once the health care provider experiences the difference with OLINVYK they want to continue to use it. With that, let me turn the call over to Mark to discuss the initial VOLITION and ARTEMIS data and our other clinical programs in more depth.

雖然基數仍然很小，但每個訂單的紙箱數量和再訂購率都在增加，這表明一旦醫療保健提供者體驗到 OLINVYK 的差異，他們就希望繼續使用它。有了這個，讓我把電話轉給馬克，更深入地討論最初的 VOLITION 和 ARTEMIS 數據以及我們的其他臨床項目。

Thanks, Patty. I'd like to begin with a review of the initial top line results from the VOLITION study. We're very pleased with these initial results. VOLITION was designed as a real-world outcome study and was led by the Health Outcomes team at Cleveland Clinic with Wake Forest Baptist Health as the other participating medical center. The study investigated clinical outcomes among OLINVYK treated patients undergoing major noncardiac surgical procedures in an inpatient setting. IV OLINVYK was used as the first-line analgesic during postoperative care, consistent with product labeling. 203 patients were enrolled in this study, very much a real-world population comprised of complex patients who had a moderate to severe burden of medical and surgical risk at the time of enrollment.

謝謝，帕蒂。我想首先回顧一下 VOLITION 研究的初步頂線結果。我們對這些初步結果感到非常滿意。 VOLITION 被設計為一項真實世界的結果研究，由克利夫蘭診所的健康結果團隊領導，Wake Forest Baptist Health 是另一個參與的醫療中心。該研究調查了 OLINVYK 治療的患者在住院環境中接受主要非心臟手術的臨床結果。 IV OLINVYK 被用作術後護理期間的一線鎮痛藥，與產品標籤一致。 203 名患者參加了這項研究，這是一個由複雜患者組成的真實世界人群，他們在入組時具有中度至重度的醫療和手術風險負擔。

I'll review the main top line findings from the study for the GI and the cognitive outcomes both of which were exploratory aims in the study. The respiratory data is not yet available, and we expect to report these outcomes in the coming months. Our prespecified GI endpoint was the presence of a complete GI response which was met in any patient who did not vomit and did not require use of rescue antiemetics throughout the postoperative period.

我將回顧 GI 研究的主要頂線發現和認知結果，這兩者都是該研究的探索性目標。呼吸數據尚不可用，我們預計將在未來幾個月內報告這些結果。我們預先指定的 GI 終點是出現完全的 GI 反應，在整個術後期間沒有嘔吐並且不需要使用補救止吐藥的任何患者都符合這一點。

In VOLITION, 52.2% of OLINVYK treated patients showed a complete GI response. For reference, these outcomes are consistent with the GI tolerability data seen in our pivotal Phase III pooled patient data and represented in our label. Regarding our prespecified cognitive end points, 3.9% of VOLITION patients or 8 of the 203 enrolled patients exhibited symptoms suggesting the presence of delirium, measured using the validated 3D CAM bedside screening tool.

在 VOLITION 中，52.2%的 OLINVYK 治療患者表現出完全的 GI 反應。作為參考，這些結果與在我們關鍵的 III 期合併患者數據中看到的 GI 耐受性數據一致，並在我們的標籤中表示。關於我們預先指定的認知終點，3.9% 的 VOLITION 患者或 203 名登記患者中的 8 名表現出表明存在譫妄的症狀，使用經過驗證的 3D CAM 床邊篩查工具進行測量。

We chose to focus on delirium since it is among the most clinically and economically important events that may complicate and extend postoperative care. The incidence of delirium reported in the scientific literature can vary widely based on the population and treatment settings studied. In a recent meta-analysis of 33 studies in medical in-patients, the overall incidence of delirium was reported as 23%. Among high-risk patients undergoing major surgery, rates of delirium have been reported to exceed 20%.

我們選擇專注於譫妄，因為它是臨床和經濟上最重要的事件之一，可能使術後護理複雜化並延長術後護理。根據所研究的人群和治療環境，科學文獻中報導的譫妄發生率可能會有很大差異。在最近對 33 項住院患者研究的薈萃分析中，譫妄的總發生率為 23%。據報導，在接受大手術的高危患者中，譫妄發生率超過 20%。

IV opioids are recognized as a contributing factor for delirium risk in the hospital setting. An additional exploratory measure of the patient's level of agitation or sedation in this study was obtained with the Richmond Agitation-Sedation Scale. And we found that over 90% of OLINVYK-treated patients were rated as alert and calm at every observation point beginning on the first postoperative morning.

IV 阿片類藥物被認為是醫院環境中譫妄風險的一個促成因素。在本研究中，通過里士滿激越-鎮靜量表對患者的激越或鎮靜水平進行了額外的探索性測量。我們發現，在術後第一個早晨開始的每個觀察點，超過 90% 的接受 OLINVYK 治療的患者被評為警覺和平靜。

We view these exploratory data as consistent with the incidence of delirium observed on the 3D CAM scores. In order to study these outcomes in more detail, we extracted the electronic medical record, or EMR data, from surgical patients treated at the study hospitals around the same period of time that the VOLITION study was conducted. We refer to this EMR data set as the ARTEMIS study.

我們認為這些探索性數據與 3D CAM 評分中觀察到的譫妄發生率一致。為了更詳細地研究這些結果，我們從大約在進行 VOLITION 研究的同一時期在研究醫院接受治療的手術患者中提取了電子病歷或 EMR 數據。我們將此 EMR 數據集稱為 ARTEMIS 研究。

We believe these EMR data bring a unique perspective to an understanding of how drugs perform in the real world. The importance of real-world data sources like these EMR data sets have been discussed by FDA in a variety of contexts and are among the provisions considered in the 21st Century Cures Act to help inform and accelerate the development of new drugs. At this time, we've analyzed the EMR data set extracted from the Wake Forest study site, the largest enrolling site in the VOLITION study, which was comprised of 96 OLINVYK-treated patients.

我們相信這些 EMR 數據為理解藥物在現實世界中的表現帶來了獨特的視角。 FDA 在各種情況下討論了這些 EMR 數據集等真實世界數據源的重要性，並且是 21 世紀治愈法案中考慮的條款之一，以幫助告知和加速新藥的開發。目前，我們已經分析了從維克森林研究中心提取的 EMR 數據集，維克森林研究中心是 VOLITION 研究中最大的註冊中心，由 96 名接受 OLINVYK 治療的患者組成。

Using a validated propensity score-based matching algorithm, we identified a matched group of 457 comparable surgical patients who were treated with an IV opioid other than OLINVYK for their postoperative acute pain, the control patient population. I'd like to summarize some key findings on the health care utilization of these 2 groups. While there was no significant difference in PACU times, both groups were about 2.5 hours.

使用經過驗證的基於傾向評分的匹配算法，我們確定了一個由 457 名可比較的手術患者組成的匹配組，這些患者接受了 OLINVYK 以外的靜脈注射阿片類藥物治療術後急性疼痛，即對照患者群體。我想總結一下這兩個群體的醫療保健利用情況的一些主要發現。雖然 PACU 時間沒有顯著差異，但兩組均約為 2.5 小時。

OLINVYK-treated patients in the ARTEMIS study had a statistically significant 1.6 days or 27% in average hospital length of stay versus the match cohort of surgical patients treated with other IV opioids, including IV morphine, hydromorphone or fentanyl. Looking more closely in the 2 populations, there were comparable proportions of patients who experienced an episode of postoperative vomiting, 24 OLINVYK-treated patients, 99 patients in the controlled group. However, in these subgroups, the reduction in hospital length of stay remained apparent with OLINVYK-treated patients continuing to show a statistically significant 2.1 days or 29% reduction in average length of hospital stay.

在 ARTEMIS 研究中，接受 OLINVYK 治療的患者平均住院時間為 1.6 天或 27%，與接受其他 IV 阿片類藥物（包括 IV 嗎啡、氫嗎啡酮或芬太尼）治療的手術患者的匹配隊列相比具有統計學意義。在這兩個人群中更仔細地觀察，有相當比例的患者經歷了術後嘔吐，24 名接受 OLINVYK 治療的患者，99 名患者在對照組中。然而，在這些亞組中，住院時間的減少仍然明顯，接受 OLINVYK 治療的患者繼續顯示出具有統計學意義的平均住院時間減少 2.1 天或 29%。

While the reason for this difference in length of stay is not yet clear, we believe it may be related to the average duration and variability in the duration of vomiting, which were both numerically lower in the OLINVYK treated group. The difference in duration was not statistically different but there was a statistically significant narrower range of variability in the duration of vomiting among the OLINVYK treated patients.

雖然這種住院時間差異的原因尚不清楚，但我們認為這可能與嘔吐持續時間的平均持續時間和變異性有關，這在 OLINVYK 治療組中均較低。持續時間的差異沒有統計學差異，但在接受 OLINVYK 治療的患者中，嘔吐持續時間的變異性範圍在統計學上顯著縮小。

In other words, these data suggest that though there were no significant differences between the groups in whether vomiting occurred, the clinical severity may be lower among patients treated with OLINVYK. With respect to cognitive outcomes and delirium, we use the recognized set of ICD codes recorded in the EMR to assess the presence of delirium or altered consciousness between the groups. In this prespecified endpoint, patients treated with other IV opioids experienced more ICD coded events of delirium and altered consciousness, then patients treated with IV OLINVYK or 4.4% compared to 1.04%. Though this difference was not statistically significant, when delirium occurs, it is a clinically and economically consequential event. Pooling the overall study population, the presence of an ICD code of delirium or altered consciousness in any patient increased the hospital length of stay by an average of 10.5 days.

換句話說，這些數據表明，儘管兩組之間是否發生嘔吐沒有顯著差異，但接受 OLINVYK 治療的患者的臨床嚴重程度可能較低。關於認知結果和精神錯亂，我們使用 EMR 中記錄的公認 ICD 代碼集來評估各組之間是否存在精神錯亂或意識改變。在這個預先設定的終點中，接受其他 IV 阿片類藥物治療的患者經歷了更多 ICD 編碼的譫妄和意識改變事件，然後接受 IV OLINVYK 治療的患者或 4.4% 與 1.04% 相比。雖然這種差異在統計學上並不顯著，但當發生譫妄時，它是一個臨床和經濟上的後果事件。匯集整個研究人群，任何患者出現 ICD 代碼的譫妄或意識改變會使住院時間平均增加 10.5 天。

To summarize, EMR analysis showed that OLINVYK treated patients stayed an average of 1.6 fewer days in the hospital compared to patients treated with other IV opioids. Over half of OLINVYK-treated patients in VOLITION exhibited a complete GI response over 90% were rated as alert and calm at every observation point. And under 4% of OLINVYK-treated patients showed symptoms suggesting delirium. I'll also note that additional analyses of the respiratory data and the EMR data may not be consistent with the initial data I'm describing today. Nevertheless, we're encouraged by these results and look forward to reporting more data as soon as they are available.

總而言之， EMR 分析顯示，與接受其他 IV 阿片類藥物治療的患者相比，接受 OLINVYK 治療的患者在醫院的平均停留天數減少了1.6天。在 VOLITION 中，超過一半接受 OLINVYK 治療的患者表現出完全的 GI 反應，超過 90% 的患者在每個觀察點都被評為警覺和平靜。在接受 OLINVYK 治療的患者中，不到 4% 的患者出現了精神錯亂的症狀。我還會注意到，對呼吸數據和 EMR 數據的額外分析可能與我今天描述的初始數據不一致。儘管如此，我們對這些結果感到鼓舞，並期待在獲得更多數據後儘快報告。

Let me turn my attention now to TRV045. This has been another quarter of significant progress with 045, our novel S1P receptor modulator. I'm excited to share the continued clinical progress we've made over the past few months. In January, we announced that we enrolled the first subject in our first TRV045 proof-of-concept trial, evaluating S1P receptor mechanism of action and target engagement. The goal of this study, a randomized, double-blind, placebo-controlled 4-way crossover study is to build on nonclinical evidence of anti-inflammatory signaling and the potential disease-modifying effect of 045 in the treatment of epilepsy and other CNS disorders.

現在讓我將注意力轉向 TRV045。這是我們的新型 S1P 受體調節劑 045 又取得重大進展的四分之一。我很高興能分享我們在過去幾個月中取得的持續臨床進展。 1 月，我們宣布我們在第一個 TRV045 概念驗證試驗中招募了第一個受試者，評估 S1P 受體作用機制和目標參與。這項研究是一項隨機、雙盲、安慰劑對照的 4 路交叉研究，其目的是建立在抗炎信號的非臨床證據和 045 治療癲癇和其他中樞神經系統疾病的潛在疾病緩解作用的基礎上.

The study is expected to complete enrollment by mid-2023. We're on track to that target, and we're approximately halfway through the study enrollment. Based on this progress, we expect to report top line data in the third quarter of this year. I'm also pleased to announce the initiation of a second proof-of-concept study for TRV045, which began enrolling subjects this month. The second study is a randomized, double-blind, placebo-controlled, 2-way crossover multiple dose study designed to evaluate the pharmacodynamic effect of 045 on cortical excitability in healthy male adults.

該研究預計將在 2023 年中期完成招募。我們正在朝著這個目標前進，我們大約已經完成了研究招募的一半。基於這一進展，我們預計將在今年第三季度報告營收數據。我也很高興地宣布啟動 TRV045 的第二項概念驗證研究，該研究於本月開始招募受試者。第二項研究是一項隨機、雙盲、安慰劑對照、雙路交叉多劑量研究，旨在評估 045 對健康男性皮層興奮性的藥效學影響。

The study will use transcranial magnetic stimulation, electromyography and electroencephalography to measure the potential effect of 045 on brain function relevant to epilepsy and other CNS (inaudible). We also expect to have this study fully enrolled by midyear with top line data expected in the third quarter. Both of these proof-of-concept studies are not being conducted under the IND for 045 and all subjects will be enrolled at a study site outside the U.S. Our clinical development team is pleased with the progress we've made with 045, and I look forward to updating you on these 2 studies in the coming months.

該研究將使用經顱磁刺激、肌電圖和腦電圖來測量 045 對與癲癇和其他中樞神經系統（聽不清）相關的腦功能的潛在影響。我們還希望在年中之前完成這項研究，並在第三季度獲得頂線數據。這兩項概念驗證研究均未根據 045 的 IND 進行，所有受試者都將在美國以外的研究地點註冊。我們的臨床開發團隊對我們在 045 上取得的進展感到滿意，我看期待在接下來的幾個月中為您更新這兩項研究。

I'll now turn the call over to Barry to review our fourth quarter financials. Barry?

我現在將電話轉給巴里審查我們第四季度的財務狀況。巴里？

Thanks, Mark. In the fourth quarter, our net loss was $7 million or $0.73 per share compared to $14 million or $2.12 per share for the same period last year. As Patty mentioned, we continue to see usage from ASCs and hospitals, which our distributors are fulfilling from existing inventories. We are focused on tightly managing our expenses and cost effectively advancing our pipeline. We finished the quarter with $38.3 million in cash and marketable securities, which we believe will fund our operations into the fourth quarter of 2023 past expected final VOLITION data for OLINVYK and readouts for our 2 proof-of-concept studies for TRV045.

謝謝，馬克。第四季度，我們的淨虧損為 700 萬美元或每股 0.73 美元，而去年同期為 1400 萬美元或每股 2.12 美元。正如 Patty 提到的，我們繼續看到來自 ASC 和醫院的使用，我們的分銷商正在從現有庫存中履行這些職責。我們專注於嚴格管理我們的費用和成本有效地推進我們的管道。我們以 3830 萬美元的現金和有價證券結束了本季度，我們相信這將為我們到 2023 年第四季度的運營提供資金，超過 OLINVYK 的預期最終 VOLITION 數據和我們 TRV045 的 2 項概念驗證研究的讀數。

In addition, we may also receive up to $18 million of non-dilutive funding if certain stones are met. That's $3 million from our partner Nhwa on Chinese approval of OLINVYK and $15 million from R-Bridge on first commercial sale of OLINVYK in China, and Nhwa has informed us they expect regulatory decision on OLINVYK in the first half of this year. I'd note that $18 million of expected non-dilutive funding with less than 9 million shares currently outstanding, and this would meaningfully extend our runway. In this environment, we also continue to investigate partnering and other opportunities, which may provide additional resources and build shareholder value.

此外，如果滿足某些條件，我們還可能獲得高達 1800 萬美元的非稀釋資金。我們的合作夥伴 Nhwa 為 OLINVYK 在中國的批准提供了 300 萬美元，R-Bridge 為 OLINVYK 在中國的首次商業銷售提供了 1500 萬美元，Nhwa 告訴我們他們預計今年上半年將對 OLINVYK 做出監管決定。我會注意到 1800 萬美元的預期非稀釋性資金，目前流通股不到 900 萬股，這將有意義地延長我們的跑道。在這種環境下，我們還繼續研究合作夥伴關係和其他機會，這可能會提供額外的資源並建立股東價值。

We'll now open the call for questions, after which Carrie will provide some closing remarks. Operator?

我們現在開始提問，之後 Carrie 將發表一些結束語。操作員？

(Operator Instructions) Our first question comes from the line of Jason Butler with JMP Securities.

（操作員說明）我們的第一個問題來自 Jason Butler 與 JMP Securities 的對話。

Congrats on the progress. I had a couple on 045 and then one on OLINVYK. Just for the magnetic stimulation trial, are there precedents or controls that you can point to hear that, that could give a benchmark of a magnitude of change that would be predictive of clinical benefit? And then I know that you may want to hold off on this until you have the data, but just any thoughts about the broader strategy in epilepsy, whether you're focused on broader focal onset seizure for example, populations versus rare genetic populations?

祝賀進步。我在 045 上有一對，然後在 OLINVYK 上有一個。就磁刺激試驗而言，是否有先例或對照可以讓您聽到，這可以給出預測臨床益處的變化幅度的基準？然後我知道你可能想在獲得數據之前暫緩討論這個問題，但是關於更廣泛的癲癇策略的任何想法，你是否專注於更廣泛的局灶性癲癇發作，例如人群與罕見遺傳人群？

Yes. Let me have Mark go ahead and answer the first question around the TMS.

是的。讓我讓馬克繼續回答有關 TMS 的第一個問題。

Yes. Thank you, Jason. With regard to the TMS paradigm, it actually is a very well-validated paradigm in -- used in drug development. So both from the point of view of its validation as well as its experimental use with a variety of antiepileptics that are either in development or already on the market, we have a good sense of the endpoints and the size that we would expect to see that would be relevant from a clinical perspective. It's really a body of work that allows us to -- once we get our results be able to place them in context with what we would expect to see in future clinical studies. So we're very pleased with the model. I think it can be quite useful.

是的。謝謝你，傑森。關於 TMS 範例，它實際上是一個非常有效的範例——用於藥物開發。因此，無論是從其驗證的角度來看，還是從其與正在開發或已經上市的各種抗癲癇藥的實驗性使用的角度來看，我們都對終點和我們期望看到的規模有很好的了解從臨床角度來看是相關的。這確實是一項工作，讓我們能夠——一旦我們得到結果，就能夠將它們與我們期望在未來的臨床研究中看到的內容聯繫起來。所以我們對這個模型非常滿意。我認為它可能非常有用。

And then with regard to the broader strategy, I mean, as you said, we're not quite ready to declare yet. We also will be getting some additional nonclinical data that will help us make additional decisions right around rare versus local. So more to come on that, but we're also very pleased with the progress we're making with 045.

然後關於更廣泛的戰略，我的意思是，正如你所說，我們還沒有準備好宣布。我們還將獲得一些額外的非臨床數據，這些數據將幫助我們圍繞稀有與本地做出額外的決定。所以還有更多的事情要做，但我們也對我們在 045 上取得的進展感到非常高興。

Great. And then just on the ARTEMIS results for OLINVYK. With the -- nice to see the 1.6 day reduction in hospital stay versus other IV opioids. Was there a specific driver there? So was it more driven by GI or delirium or other cognitive effects? Or was it a mixture of all of them?

偉大的。然後就是 OLINVYK 的 ARTEMIS 結果。與 - 很高興看到住院時間與其他 IV 阿片類藥物相比減少了 1.6 天。那裡有特定的驅動程序嗎？那麼它更多是由 GI 或精神錯亂或其他認知影響驅動的嗎？或者它是所有這些的混合物？

It's a great question, Jason. And that's why we drilled into the character of the vomiting signal. And it's why I emphasized in the remarks the impact of delirium overall. So I think the answer to your question is that while I can't draw a direct line for you between a specific event and its specific impact on the duration of hospital stay. I think what we can speculate is that these are certainly contributors to the overall trajectory in the hospital. But obviously, it's a very complicated -- it's a very complicated set of factors. Obviously, there's multiple things going on during the hospital stay.

這是一個很好的問題，傑森。這就是我們深入研究嘔吐信號特徵的原因。這就是為什麼我在評論中強調了精神錯亂的整體影響。所以我認為你的問題的答案是，雖然我不能在特定事件和它對住院時間的具體影響之間為你畫一條直線。我認為我們可以推測的是，這些肯定是醫院整體發展軌蹟的貢獻者。但顯然，這是非常複雜的——這是一組非常複雜的因素。顯然，在住院期間發生了很多事情。

I would emphasize though it's sort of -- I said this in my words, but just to point out, the thing that's so remarkable about the finding is it's a pretty good, large representative data set from a homogeneous single site sample, well-matched and highly statistically significant at 1.6-day extension length of stay. I didn't mention the p-value, but it's got three 0s and 1 in it. So we're really quite excited about the finding. And I think to answer your question in more detail, is really the kind of work that's ahead of us and looking more closely at the data.

我要強調的是——我是用我的話來說的，但只是想指出，這一發現的非凡之處在於它是一個非常好的、具有代表性的大型數據集，來自同質的單一站點樣本，匹配良好並且在延長 1.6 天的住院時間時具有高度統計顯著性。我沒有提到 p 值，但其中包含三個 0 和 1。所以我們對這一發現感到非常興奮。而且我認為更詳細地回答你的問題，確實是我們前面的工作，並且更仔細地查看數據。

Yes, we were pretty -- we were very excited about that data point in particular, the 1.6 days. That's -- yes, that's a meaningful difference.

是的，我們很漂亮——我們對那個數據點感到非常興奮，尤其是 1.6 天。那是——是的，這是一個有意義的差異。

Thanks, Carrie, and congrats on the results.

謝謝，嘉莉，並祝賀結果。

(Operator Instructions) Our next question comes from the line of Brandon Folkes with Cantor Fitzgerald.

（操作員說明）我們的下一個問題來自 Brandon Folkes 和 Cantor Fitzgerald。

Congratulations on the progress. Maybe just one from me. Can we just take a step back on OLINVYK and think about this? Obviously, you continue to generate pretty good data on the product. It's obviously tough to get -- it's a tough space to be selling a product. But what do you think sort of is the hurdle as we move forward here to maybe sort of getting people to switch across to OLINVYK? Is it just continued generation of data?

祝賀你的進步。也許只有我一個。我們能不能退後一步來考慮一下 OLINVYK？顯然，您繼續在產品上生成非常好的數據。顯然很難獲得——這是一個銷售產品的艱難空間。但是你認為我們在這裡前進的障礙是什麼，可能會讓人們轉向 OLINVYK？它只是繼續生成數據嗎？

Why is sort of the data that lies ahead or we have in hand potentially sort of more impactful than the data we've had in the past. Just any feedback from the field that you think sort of could actually drive revenue pull-through as we go forward?

為什麼前面的數據或我們手頭的數據可能比我們過去擁有的數據更具影響力。在我們前進的過程中，您認為來自該領域的任何反饋實際上可以推動收入增長嗎？

Brandon, it's a great question. I'll start, and then I'll have Patty dive in as well. So the couple of things. As you said, we've had -- we put some data out, right, the head-to-head data that we previously. I will say those data sets while they've been generally supportive and they've been part of the discussions we're having with formulary committees, they've been smaller data sets and healthy volunteers.

布蘭登，這是一個很好的問題。我先開始，然後讓 Patty 也參與進來。所以兩件事。正如你所說，我們已經 - 我們發布了一些數據，對，我們之前的頭對頭數據。我會說這些數據集，雖然他們普遍支持並且他們一直是我們與處方集委員會討論的一部分，但他們是較小的數據集和健康的志願者。

This new data set is really what we've been hearing from our customers that they've been looking for it, right, real-world data in patients, robust from large academic medical centers, the added benefit then of having the electronic medical record process data around length of stay also helps that discussion. So we're directly answering the question that we've had, frankly, since launch. Where is the real-world data? Can you show us how this might impact or benefit the cost system?

這個新數據集確實是我們從客戶那裡聽到的，他們一直在尋找它，對，患者的真實世界數據，來自大型學術醫療中心的強大數據，以及擁有電子病歷的額外好處圍繞住院時間處理數據也有助於討論。因此，坦率地說，我們正在直接回答自發布以來我們遇到的問題。真實世界的數據在哪裡？您能否向我們展示這將如何影響或有益於成本系統？

I will also say, though, that the inpatient setting is struggling, right? Margins are tight. We're still seeing hospital formulary delays. And with the focus on costs, they're very comfortable using IV morphine, IV hydromorphone. So it's going to take something like this data set to really think breakdown some of those barriers. And you hear what Patty is describing is, we're still trying to drive experience. And the fastest way for us to do that is in the ambulatory surgery centers, because hospitals are still experiencing delay.

不過，我還要說的是，住院環境很艱難，對吧？利潤率很低。我們仍然看到醫院處方延遲。由於關注成本，他們很樂意使用靜脈注射嗎啡、靜脈注射氫嗎啡酮。因此，需要像這個數據集這樣的東西才能真正思考打破其中的一些障礙。你聽到 Patty 所描述的是，我們仍在努力提升體驗。對我們來說，最快的方法是在門診手術中心，因為醫院仍在經歷延誤。

So it's not -- we're not where we'd like to be. We're doing everything we can to sort of get things moving. It's not necessarily additional data beyond this big data set because, as Mark said, we're still going to be collecting data from this data set because we are also managing our expenses and looking to 045 in the pipeline. But Patty, I don't know what are you seeing in the field?

所以它不是 - 我們不是我們想去的地方。我們正在盡我們所能來推動事情的進展。它不一定是這個大數據集之外的額外數據，因為正如馬克所說，我們仍然會從這個數據集中收集數據，因為我們也在管理我們的開支並期待 045 在管道中。但是帕蒂，我不知道你在現場看到了什麼？

You said it very well. The inpatient setting is extremely difficult because of residual effects of the pandemic. ASCs represent an opportunity for us because of the reasons I listed with the more complex surgeries happening. It's a growing area of health care in general. We have access to those people and they can get experience that they can parlay them into a hospital setting.

你說得很好。由於大流行的殘餘影響，住院環境極其困難。由於我列出了發生更複雜手術的原因，ASC 對我們來說是一個機會。總的來說，這是一個不斷增長的醫療保健領域。我們可以接觸到這些人，他們可以獲得可以讓他們進入醫院環境的經驗。

What I'm most excited about in terms of the data that Mark has been able to generate with the team is exactly what you're talking about length of stays in area that's of critical importance to the inpatient setting and having such definitive data coming out is important.

就 Mark 能夠與團隊生成的數據而言，我最興奮的正是你所說的在對住院環境至關重要的區域停留的時間長度，並且有這樣明確的數據出來很重要。

Now it's going to take some time because we have to let medical do what they do first. And that is that this data needs to get into our dossier. We're going to be presenting it at congresses, published, et cetera. It takes time before it comes into the commercial hands for active promotion, but we're certainly looking forward to having that happen, and we'll certainly pursue that aggressively.

現在這需要一些時間，因為我們必須讓醫療部門先做他們做的事情。那就是這些數據需要進入我們的檔案。我們將在大會上展示它，出版等等。它進入商業手中進行積極推廣需要時間，但我們當然期待著這一切發生，我們一定會積極追求這一點。

And a follow-up on that, if I may. Do you expect the hospitals or ASC systems to want to run their own experience trials right on the back of this data as well would expect this data to sort of be sufficient out there given its real-world data to actually drive sort of use?

如果可以的話，還有後續行動。您是否希望醫院或 ASC 系統希望在這些數據的支持下運行他們自己的體驗試驗，以及是否希望這些數據在某種程度上足夠，因為它的真實世界數據實際上可以推動某種使用？

Yes. I'm pointing to Mark because he's had -- we -- this data, as you can imagine, is fresh off the press. But you've had some conversations -- yes.

是的。我指的是馬克，因為他有——我們——這些數據，正如你想像的那樣，是剛從媒體上出來的。但是你們進行了一些對話——是的。

We've had conversations with providers from time to time about an interest in observing a cohort of patients in their hands as they use OLINVYK. We have not had any formal data output from those conversations at this point. I do think that the data we have is different than what we've had in our Phase III studies that we've presented and talked with providers about in that. This is actual real-world experience and use of the product.

我們不時與提供者進行對話，討論在他們使用 OLINVYK 時觀察他們手中的一組患者的興趣。目前，我們還沒有從這些對話中獲得任何正式數據輸出。我確實認為我們擁有的數據與我們在 III 期研究中所擁有的數據不同，我們已經在其中展示並與供應商討論過。這是產品的真實體驗和使用。

The idea of extracting the information from directly from an institution's medical record and analyzing it that way is a fundamentally different type of information. And I think providers recognize that. So while certainly personal experience is pretty compelling for any clinician, the ability to look at data like this is, I think, an important incremental step in the type of data and the quality of the data that we're providing to providers.

直接從機構的醫療記錄中提取信息並以這種方式進行分析的想法是一種根本不同的信息類型。我認為供應商認識到這一點。因此，雖然個人經驗對任何臨床醫生來說都非常有吸引力，但我認為，像這樣查看數據的能力是我們向提供者提供的數據類型和數據質量的重要增量步驟。

I mean I also think because it's Cleveland Clinic and Wake Forest, 2 really well-recognized institutions, that carries a lot of weight, right? It's hard for me to say that another large academic medical center wouldn't want to try to do a repeat, but at least with some of the major institutions we're calling on, the community, community teaching, I think this data is going to carry the way.

我的意思是我也認為，因為它是克利夫蘭診所和維克森林，這 2 個非常知名的機構，具有很大的影響力，對吧？我很難說另一個大型學術醫學中心不想嘗試重複，但至少對於我們呼籲的一些主要機構、社區、社區教學，我認為這些數據正在發生帶路。

Congrats on the progress.

祝賀進步。

Our next question comes from the line of Douglas Tsao with H.C. Wainwright.

我們的下一個問題來自 Douglas Tsao 和 H.C.溫賴特。

Just curious, as you move into the ASC, I know there's been some sort of thought that it was perhaps a slightly less attractive market just given the volume of drug use. I'm just curious, how far can the ASC get you with pass-through status as well as the addition of complex studies. I mean can this sort of be a platform that can get you sort of approaching breakeven with OLINVYK?

只是好奇，當你進入 ASC 時，我知道有人認為考慮到藥物使用量，這可能是一個吸引力稍差的市場。我只是好奇，ASC 能在多大程度上讓您獲得通過狀態以及增加複雜的研究。我的意思是，這種平台能否讓您與 OLINVYK 接近收支平衡？

Yes, it's a great question, Doug. Let me start, and if Patty has an additional comment. So as you said, the inpatient is still really where the bulk of the opportunity is for OLINVYK. But in the ASCs, 2 things are happening. One, the more -- those complex patients, that's really sort of OLINVYK's sweet spot. They're starting to move more and more out there. And ASCs are now -- it's not just the volume over a 24-hour period.

是的，這是一個很好的問題，道格。讓我開始，如果 Patty 有補充意見。所以正如你所說，住院病人仍然是 OLINVYK 的大部分機會。但在 ASC 中，有兩件事正在發生。一，更多 - 那些複雜的患者，這確實是 OLINVYK 的最佳選擇。他們開始越來越多地搬到那裡。現在，ASC 不僅僅是 24 小時內的交易量。

But the time in which patients are staying in the ASC is growing. So that does make the opportunity a little more attractive for OLINVYK. I would still say, though, that the goal for us is to leverage pass-through, the great data that we have and get the use, get the experience in ambulatory surgery centers so that those physicians bring that experience back into the inpatient setting.

但是患者在 ASC 中停留的時間越來越長。因此，這確實讓這個機會對 OLINVYK 更具吸引力。不過，我仍然會說，我們的目標是利用傳遞，我們擁有並得到使用的重要數據，獲得門診手術中心的經驗，以便這些醫生將這些經驗帶回住院環境。

But I'll tell you, I'm seeing a lot more opportunity on OLINVYK in the ASCs than I did at launch just because of the shifting dynamics and the shifting inpatients. Patty, I mean, you're out and you've been visiting a lot of these top ASCs?

但我會告訴你，我在 ASC 中看到 OLINVYK 的機會比我在發佈時看到的更多，這僅僅是因為不斷變化的動力和不斷變化的住院病人。帕蒂，我是說，你出去了，你去過很多頂級 ASC 嗎？

Yes. Well, I've had customers directly saying that why they would love to have this on their hospital formulary that is a very difficult and lengthy process for them where they can get in an ambulatory surgical center, the immediate experience, and it doesn't take as long for them to get that process going. So that's exactly what we're doing is trying to be opportunistic here and follow where the health care trend is going in both more complex surgeries, the length of stay is elongating, so they get even more experience and then they are very interested in that and parlaying that into their hospital setting.

是的。好吧，我有客戶直接說為什麼他們喜歡在他們的醫院處方中加入這個，這對他們來說是一個非常困難和漫長的過程，在那裡他們可以進入門診手術中心，即刻體驗，但事實並非如此他們需要很長時間才能使該過程繼續進行。所以這正是我們正在做的就是在這裡嘗試機會主義並跟隨醫療保健趨勢在更複雜的手術中的發展方向，住院時間正在延長，所以他們獲得了更多的經驗，然後他們對此非常感興趣並將其運用到他們的醫院環境中。

And then just in terms of the length of stay data that you saw, it sounds like you have some signs that the GI was the primary driver. Do you have a sense of whether cognition contributed to the reduction of length of stay as well?

然後就您看到的停留時間數據而言，聽起來您有一些跡象表明 GI 是主要驅動因素。您是否知道認知是否也有助於縮短住院時間？

Yes, Doug, let me address that. I want to be clear -- the exploration of what accounts for the improvement in length of stay. I believe that the GI tolerability is the circumstantial data that I presented would suggest that it's playing a role. I wouldn't necessarily call it the primary driver because if you look at the impact of delirium, while -- as I pointed out, the incidence of delirium as declared by the provider in their ICD codes in the record, it's low.

是的，道格，讓我解決這個問題。我想說清楚——探索是什麼導致了停留時間的延長。我相信 GI 耐受性是我提供的間接數據，表明它正在發揮作用。我不一定將其稱為主要驅動因素，因為如果您查看精神錯亂的影響，而——正如我所指出的，提供者在記錄的 ICD 代碼中聲明的精神錯亂的發生率很低。

On the other hand, when it occurs, it's an enormous event. 10.5-day extension of length of stay in -- on average in patients who experience an episode of delirium, you don't need many of those to contribute significantly to a prolonged length of stay. So trying to get -- as mentioning in the answer to Jason, trying to sort of be very specific about the proportion contribution from these different issues to length of stay is kind of -- is very hard to do.

另一方面，當它發生時，它是一個巨大的事件。住院時間延長 10.5 天——平均而言，對於經歷過一次譫妄發作的患者，你不需要很多這樣的藥物來顯著延長住院時間。因此，試圖獲得——正如在對傑森的回答中提到的那樣，試圖非常具體地說明這些不同問題對停留時間的貢獻比例——是很難做到的。

But I think the circumstantially, the data would argue that these 2 features are certainly playing a role amongst other factors. And again, we're going to keep looking at this data more closely to help give a little bit more color to what's behind this.

但我認為，從情況來看，數據會證明這兩個特徵肯定在其他因素中發揮了作用。再一次，我們將繼續更密切地關注這些數據，以幫助為背後的事物提供更多色彩。

And Doug, let me just say that from my perspective, certainly, I was very excited about the entire data set. But the cognition, the delirium data is extremely interesting to me, right? It's not an area that we had studied previously in our Phase III studies. We had done the head-to-head study in healthy volunteers earlier, I guess, last year when we announced the results. So this now data set in patients in a real-world setting was very impressive to me. So more to come, I think, on this area for us.

道格，我只想說，從我的角度來看，我對整個數據集感到非常興奮。但是認知，譫妄數據對我來說非常有趣，對吧？這不是我們之前在 III 期研究中研究過的領域。我想，我們早在去年公佈結果時就已經在健康志願者中進行了頭對頭研究。所以現在這個真實世界環境中患者的數據集給我留下了深刻的印象。我認為，在這個領域，我們還會有更多的事情要做。

And one quick follow-up. In terms of delirium, does that an onset after a single dose of morphine or is it something that is a result of sort of the repeated use? And if you stop using the morphine just the delirium to see its fairly quickly?

並進行一次快速跟進。就譫妄而言，這是在單劑量嗎啡後發作還是重複使用的結果？如果你停止使用嗎啡只是譫妄來相當快地看到它？

Again, a good question. And as you know, delirium is kind of a final common pathway brain dysfunction event. So in a hospital setting, there are typically multiple factors that are likely at play, the use of an IV opioid being an important but only one of multiple factors. So it really is very specific to a patient as to whether or not altering the drug regimen is going to be the key that will abort the delirium in a particular patient.

又是一個好問題。如您所知，譫妄是一種最終的共同通路腦功能障礙事件。因此，在醫院環境中，通常有多種因素可能在起作用，靜脈注射阿片類藥物是一個重要但只是多種因素之一。因此，關於改變藥物治療方案是否將成為終止特定患者譫妄的關鍵，對於患者來說確實是非常具體的。

So that's -- it's a little bit more complicated because of the multiple factors that are involved. But again, IV opioids are recognized to play an important contributing role amongst other factors in the risk of delirium in a hospitalized patient.

這就是 - 由於涉及多種因素，它有點複雜。但同樣，IV 阿片類藥物被認為在住院患者發生譫妄風險的其他因素中起著重要的作用。

Thank you. Ladies and gentlemen, that concludes our question-and-answer session. I'll turn the floor back to Ms. Bourdow for any final comments. Great.

謝謝。女士們，先生們，我們的問答環節到此結束。最後請 Bourdow 女士發言。偉大的。

Thank you. And again, thank you for your questions. As you hear, it was a busy quarter for us, and we're excited that we're starting to see initial OLINVYK results from the VOLITION study. We're continuing to make great progress on TRV045, our novel S1P receptor modulator. We have multiple upcoming milestones, including the regulatory update from Nhwa in the first half of this year that they're expecting. So we'll continue to update you as we learn more. Thank you again for tuning in this morning.

謝謝。再次感謝您的提問。正如您所聽到的，這對我們來說是一個繁忙的季度，我們很高興我們開始看到 VOLITION 研究的初步 OLINVYK 結果。我們將繼續在我們的新型 S1P 受體調節劑 TRV045 上取得重大進展。我們有多個即將到來的里程碑，包括他們期待的今年上半年 Nhwa 的監管更新。因此，隨著我們了解更多信息，我們將繼續為您更新。再次感謝您今天早上的調音。

Thank you. This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.

謝謝。今天的會議到此結束。此時您可以斷開線路。感謝您的參與。