Savara Inc. (SVRA) 2020 Q2 法說會逐字稿

Welcome to the Savara conference call. (Operator Instructions) An audio webcast of this call will be available on the Investors section of Savara's website, at savarapharma.com. This call is subject to copyright and is the property of Savara. All recordings, reproduction, and transmission of this call without the expressed written consent of Savara is strictly prohibited. As a reminder, today's call is being recorded.

歡迎參加 Savara 電話會議。（操作員說明）本次電話會議的音頻網絡廣播將在 Savara 網站 savarapharma.com 的投資者部分提供。此電話受版權保護，是 Savara 的財產。未經 Savara 明確書面同意，嚴禁對本次通話進行任何錄音、複製和傳輸。提醒一下，今天的通話正在錄音中。

I would now like to turn the call over to Anne Erickson, Head, Investor Relations and Corporate Communications at Savara.

我現在想把電話轉給 Savara 的投資者關係和企業傳播主管 Anne Erickson。

Good afternoon, and thank you for joining us today. A press release reporting our second quarter 2020 financial results was issued earlier today, August 6, 2020, and can be found on the Investors section of our Web site, at savarapharma.com. If you have not received this release or you would like to be added to the company's distribution list, please e-mail me at ir@savarapharma.com. This call is also being webcast live, and one hour after the call a replay will be available on the company's Web site and will remain available for the next 30-days. A telephone replay will be available through August 13.

下午好，感謝您今天加入我們。報告我們 2020 年第二季度財務業績的新聞稿已於今天（2020 年 8 月 6 日）早些時候發布，可在我們網站 savarapharma.com 的投資者部分找到。如果您還沒有收到此新聞稿，或者您想加入公司的分發名單，請發送電子郵件至 ir@savarapharma.com。此電話會議還進行了網絡直播，電話會議一小時後，公司網站上將提供重播，並將在接下來的 30 天內保持可用。電話重播將在 8 月 13 日之前提供。

Today's conference call and webcast contain forward-looking statements within the meaning of federal securities laws, including statements regarding the company's strategy, goals, product candidates, clinical studies, and financing matters. Such statements are subject to significant risks and uncertainties, including those described in our press release issued today, Thursday, August 6, 2020, and our recent SEC filings on Forms 8-K, 10-K, and 10-Q. Actual results or performance may differ materially from the expectations indicated by our forward-looking statements due to those risks and uncertainties. We caution you not to place undue reliance on any of the forward-looking statements, which speak only as of today.

今天的電話會議和網絡廣播包含聯邦證券法含義內的前瞻性陳述，包括關於公司戰略、目標、候選產品、臨床研究和融資事項的陳述。此類聲明存在重大風險和不確定性，包括我們今天（2020 年 8 月 6 日，星期四）發布的新聞稿以及我們最近向美國證券交易委員會提交的 8-K、10-K 和 10-Q 表格中所述的風險和不確定性。由於這些風險和不確定性，實際結果或表現可能與我們的前瞻性陳述所表明的預期存在重大差異。我們告誡您不要過分依賴任何前瞻性陳述，這些陳述僅代表今天。

We will take analysts' questions at the end of the call. However, we encourage shareholders to submit questions via e-mail to ir@savarapharma.com. Time permitting; we will address these questions alongside any others received by our IR team.

我們將在電話會議結束時回答分析師的問題。但是，我們鼓勵股東通過電子郵件向 ir@savarapharma.com 提交問題。時間允許；我們將與 IR 團隊收到的任何其他問題一起解決這些問題。

Joining me on the call today are Rob Neville, Chief Executive Officer; Badrul Chowdhury, Chief Medical Officer; Taneli Jouhikainen, President and Chief Business Officer; and Dave Lowrance, Chief Financial Officer.

今天和我一起參加電話會議的是首席執行官 Rob Neville； Badrul Chowdhury，首席醫療官； Taneli Jouhikainen，總裁兼首席商務官；首席財務官 Dave Lowrance。

I will now turn the call over to Rob.

我現在將把電話轉給 Rob。

Thank you, Anne, and good afternoon, everybody. Let me start by saying that I'm pleased with the progress we are making across our top line. Most notably, the value program - estimate that we now have finalized design for the Phase III IMPALA 2 clinical study. In a few minutes, Badrul will walk you through all the details. First, let me share at the technical team has been working diligently to get the operational aspects of the study in place and finalize so that we can get the study up and running as soon as possible.

謝謝你，安妮，大家下午好。首先讓我說，我對我們在頂線取得的進展感到滿意。最值得注意的是，價值計劃——估計我們現在已經完成了 III 期 IMPALA 2臨床研究的設計。幾分鐘後，Badrul 將帶您了解所有細節。首先，讓我分享一下技術團隊一直在努力工作，以使研究的操作方面到位並完成，以便我們能夠盡快啟動和運行研究。

One component of that work is taking prudent proactive steps to determine how to COVID proof the study as best we can. While we hope there will be no major disruptions from the virus, we are putting proactive measures in place to preserve the continuity of study to any geographies experienced a resurgence. Examples of such measures include telemedicine - visits where possible. Separately, our manufacturing and drugs supply for IMPALA 2 is progressing as planned with no discernible impact on COVID.

這項工作的一個組成部分是採取謹慎的主動步驟來確定如何盡我們所能對研究進行 COVID 證明。雖然我們希望病毒不會造成重大破壞，但我們正在採取積極措施，以保持對任何經歷過復甦的地區的研究的連續性。此類措施的例子包括遠程醫療——可能的話就診。另外，我們的 IMPALA 2 製造和藥品供應正在按計劃進行，對 COVID 沒有明顯影響。

On the topic of COVID, you may recall in March, we announced that due to practical limitations caused by the virus, we stopped enrolling patients in the Phase III AVAIL study and exploratory ENCORE study. Fortunately, we were able to keep the majority of enrolled patients in both and through post collaboration with the research centers, the studies continued.

關於 COVID 話題，大家可能還記得在 3 月份，我們宣布，由於病毒造成的實際限制，我們停止招募患者參加 III 期 AVAIL 研究和探索性 ENCORE 研究。幸運的是，通過與研究中心的後期合作，我們能夠將大部分登記患者保留在這兩個研究中心，研究繼續進行。

Regarding AVAIL enrollment numbers were smaller than originally expected with 133 enrolled out of the target of 150 in the primary analysis population, and that being younger patients between 6 and 21 years old. The older patient population completed, with 55 out of the targeted 50. By enrolling fewer patients than expected in our primary population, there will be a reduction in its count. Additionally, as we near the end of the study and think about the addressable nursing market we have to consider the impacts of Trikafta the newly approved CFTR modulator that has been transformative in the treatment of CF. While it is possible that AeroVanc could be effective when added to treatment with Trikafta, the AVAIL study does not assess that combination. Regardless, we remain optimistic that AeroVanc may play an important role in the treatment of Mercer infections by addressing the needs of specific patients within the CF community. And we look forward to announcing top line results to the AVAIL study in early 2021.

關於 AVAIL 入組人數低於最初預期，在主要分析人群的目標 150 人中有 133 人入組，而且是 6 至 21 歲之間的年輕患者。老年患者群體完成，目標 50 人中有 55 人完成。通過在我們的主要人群中招募比預期更少的患者，其數量將會減少。此外，當我們接近研究結束並考慮可尋址的護理市場時，我們必須考慮新批准的 CFTR 調節劑 Trikafta 的影響，該調節劑在 CF 的治療中具有變革性。雖然將 AeroVanc 添加到 Trikafta 治療中可能有效，但 AVAIL 研究並未評估這種組合。無論如何，我們仍然樂觀地認為，AeroVanc 可以通過滿足 CF 社區內特定患者的需求，在美世感染的治療中發揮重要作用。我們期待在 2021 年初公佈 AVAIL 研究的頂級結果。

With regard to ENCORE, that study was about 50% enrolled with 14 patients out of the target of 50 when enrollment was halted. As a reminder, ENCORE is - non controlled 48-weeks exploratory study evaluating alternatives to the treatment of non-tuberculous mycobacterial or NTM lung infection the CX. Upon this conclusion, we will determine next steps for the NTM program which also include the exploratory OPTIMA studies in non-CF patients, for which we announced applied results in March.

關於 ENCORE，該研究在停止入組時約有 50% 入組，目標 50 名患者中有 14 名患者入組。提醒一下，ENCORE 是一項為期 48 週的非對照探索性研究，評估非結核分枝桿菌或 NTM 肺部感染 CX 治療的替代方案。根據這一結論，我們將確定 NTM 計劃的後續步驟，其中還包括對非 CF 患者的探索性 OPTIMA 研究，我們在 3 月份公佈了這些研究的應用結果。

Lastly, let's turn to our U.S. development programs. Those of you not familiar, Apulmiq is an inhaled for classism and developed for the treatments of non-CF bronchitis. Our team is further analyzing the data from the previous studies that is [OVID 3 and OVID 4], and working closely with bronchitis key opinion leaders worldwide on the design of a conservatory program for future discussions with the FDA.

最後，讓我們談談我們在美國的發展計劃。那些你們不熟悉的人，Apulmiq 是一種吸入類藥物，開髮用於治療非 CF 支氣管炎。我們的團隊正在進一步分析先前研究的數據，即 [OVID 3 和 OVID 4]，並與全球支氣管炎關鍵意見領袖密切合作，設計一個未來與 FDA 討論的溫室計劃。

After similar deliberations and discussions with the agency, you will have a better sense of the necessary resources to advance Apulmiq in the U.S. Options for financing and Phase III conservatory programs include partnering to various forms of project financing. With 3 Phase III programs in our top line, the remainder of 2020 will be a very busy time operation. And importantly, we are confident about our ability to execute, as we believe we are sufficiently resourced through top line results of AVAIL and IMPALA 2.

在與該機構進行類似的審議和討論後，您將更好地了解在美國推進 Apulmiq 的必要資源。融資選項和 III 期溫室計劃包括與各種形式的項目融資合作。我們的收入中有 3 個 III 期項目，2020 年剩餘時間將是一個非常繁忙的時間。而且重要的是，我們對我們的執行能力充滿信心，因為我們相信我們通過 AVAIL 和 IMPALA 2 的頂級結果獲得了足夠的資源。

With that, I will pass the call over to Badrul, who will tell you more about our progress for the IMPALA 2.

有了這個，我會把電話轉給 Badrul，他會告訴你更多關於我們在 IMPALA 2 上的進展。

Thank you, Rob. And hello, everyone. Last quarter, we outlined the expected design of the confirmatory IMPALA 2 study following our discussions with the FDA. As noted that we are working through some additional details of the study. That was done and we now have a protocol that incorporates suggestions from the FDA and EMA.

謝謝你，羅布。大家好。上個季度，我們在與 FDA 討論後概述了確認性 IMPALA 2 研究的預期設計。如前所述，我們正在研究該研究的一些額外細節。這已經完成，我們現在有一個協議，其中包含 FDA 和 EMA 的建議。

New information of that is that the IMPALA 2 sample size will be 160 patients and we expect to start the study in the first quarter of 2021. It will be a double blind, placebo-controlled study with efficacy endpoints assessed by the week 24 for the primary analyses. However, the placebo control period will be 48-weeks to better assess the durability of treatment effect as well as long-term safety of the drug, which is intended to be administered chronically. Patients will be randomized in 1 of 2 arms, more than 300 micrograms administered dosed once daily or placebo administered once daily. At the end of the consumer control period, both treatment arms will roll over into 48-weeks open label follow on period, in which all patients will defeat no effects serum in micrograms administered once daily. While not requested by regulatory authorities, we believe follow on period will encourage patient enrollment, as it offers an incentive for patients to participate in the study. Additionally, it will provide useful information on the long-term safety of the drug.

新的信息是 IMPALA 2 的樣本量將為 160 名患者，我們預計將在 2021 年第一季度開始研究。這將是一項雙盲、安慰劑對照研究，其療效終點將在第 24 週進行初步分析評估。然而，安慰劑對照期將為 48 週，以更好地評估治療效果的持久性以及藥物的長期安全性，該藥物旨在長期給藥。患者將被隨機分配到 2 組中的 1 組，每天一次給藥超過 300 微克或每天一次給予安慰劑。在消費者控制期結束時，兩個治療組都將進入 48 週的開放標籤後續期，在此期間，所有患者都將擊敗每天一次給藥微克的無效果血清。雖然監管機構沒有要求，但我們認為後續階段將鼓勵患者入組，因為它會激勵患者參與研究。此外，它將提供有關藥物長期安全性的有用信息。

The primary endpoint of IMPALA 2 to study will be the lung function test of diffusing capacity for carbon monoxide or DLCO. Three secondary endpoints designed to measure direct patient benefit will be evaluated. Those being St. George's Respiratory Questionnaire or SGRQ total score. SGRQ activity competence score and exercise capacity using a treadmill test. With the sample size 106 locations. IMPALA 2 is 90% powered to show a difference of 5.7% conducted improvement in DLCO after week 24 with drug and placebo has changed from baseline. From the IMPALA 2 study to be considered a winning study by the FDA and the EMEA, the statistical wing on the primary endpoint of DLCO will need to be supported by evidence of efficacy across multiple clinically meaningful endpoints. While the statistical event on the secondary endpoints is not required to transmit your data across secondary and its tertiary endpoints would be considered to assess efficacy.

研究的 IMPALA 2 的主要終點將是一氧化碳擴散能力或 DLCO 的肺功能測試。將評估旨在衡量患者直接獲益的三個次要終點。那些是聖。喬治呼吸問卷或 SGRQ 總分。SGRQ 活動能力評分和使用跑步機測試的運動能力。樣本大小為 106 個位置。IMPALA 2 有 90% 的功效顯示第 24 週後藥物和安慰劑的 DLCO 與基線相比有 5.7% 的差異進行改善。從 IMPALA 2 研究被 FDA 和 EMEA 視為一項獲勝研究，DLCO 主要終點的統計翼將需要得到跨多個具有臨床意義的終點的療效證據的支持。雖然不需要次要終點上的統計事件來跨次要終點傳輸您的數據，但其第三終點將被視為評估療效。

Let me now compare some key elements of the IMPALA 2 studies with the first IMPALA study which completed in June of 2019. The primary endpoint for both studies is gas exchange measure. DLCO in IMPALA 2 AA gradient in IMPALA. DLCO by the second relation in the IMPALA study and showed the live separation between the ones till it goes in regimen and placebo. Due to treatment difference of 7.8% improvement of cloud over placebo at week 24. In the IMPALA 2 study the DLCO is measured using a standardized testing procedure and all testing sites will use the same equipment which will not be the case in the IMPALA study. Therefore, we expect to have less variability in the DLCO data. This let DLCO over AA gradient as the primary endpoint in IMPALA 2 for a variety of reasons. Mainly, it will standardize lung function test that is widely used in clinical practice. And when taking measurements, the DLCO test is less invasive than AA gradient, thus can be repeated at more time points.

現在讓我將 IMPALA 2 研究的一些關鍵要素與 2019 年 6 月完成的第一項 IMPALA 研究進行比較。兩項研究的主要終點是氣體交換測量。IMPALA 中的 DLCO 2 IMPALA 中的 AA 梯度。DLCO 通過 IMPALA 研究中的第二個關係，並顯示了兩者之間的實時分離，直到它進入養生法和安慰劑。由於在第 24 週時雲比安慰劑改善 7.8% 的治療差異。在 IMPALA 2 研究中，DLCO 是使用標準化測試程序測量的，所有測試站點都將使用相同的設備，這在 IMPALA 研究中並非如此。因此，我們預計 DLCO 數據的可變性較小。由於各種原因，這讓 DLCO 超過 AA 梯度成為 IMPALA 2 中的主要終點。主要是規範臨床廣泛應用的肺功能檢測。並且在進行測量時，DLCO 測試比 AA 梯度具有更小的侵入性，因此可以在更多時間點重複。

Additionally, in the IMPALA study, the difference between the drug and placebo are more consistent for DLCO than superior gradient and given the standardized testing tool in IMPALA 2 we believe we can improve on the DLCO results. AA gradient which could be measured in IMPALA 2 but analyzed as an explanatory end point.

此外，在 IMPALA 研究中，藥物和安慰劑之間的差異對於 DLCO 比優勢梯度更一致，並且鑑於 IMPALA 2 中的標準化測試工具，我們相信我們可以改進 DLCO 結果。可以在 IMPALA 2 中測量但作為解釋性終點進行分析的 AA 梯度。

I would like to acknowledge that the use of supplemental oxygen during overflow blood measurement was the confounding factor in the IMPALA study that impacted the AA gradient calculation. The IMPALA study protocol allowed patients to remain on supplemental oxygen during our altered by sampling, if they could not discontinue.

我想承認，在溢流血液測量期間使用補充氧氣是 IMPALA 研究中影響 AA 梯度計算的混雜因素。IMPALA 研究方案允許患者在我們通過採樣改變期間繼續使用補充氧氣，如果他們不能停止的話。

The IMPALA 2 addresses the use of oxygen as a confounding factor by specifying that patients will need to come off supplemental oxygen and be tested by pulse oximetry to make sure blood oxygenation is stabilized before either gas exchange measurement. Should patients not be able to come off supplemental oxygen, we will not conduct either gas exchange measurement in these patients and data for such patients will be missing. The study and key criteria that ensure that enrolled patients can come off supplemental oxygen for a short time period. However, it is possible that during the study the patients can use to progress particularly in the placebo arm and the patient will not be able to come off supplemental oxygen for a short time period time point in the study.

IMPALA 2 通過指定患者需要停止補充氧氣並通過脈搏血氧儀進行測試以確保血液氧合在任一氣體交換測量之前穩定，從而解決了將氧氣用作混雜因素的問題。如果患者無法停止吸氧，我們將不會對這些患者進行任何一種氣體交換測量，並且此類患者的數據將會丟失。確保入組患者可以在短時間內停止吸氧的研究和關鍵標準。然而，在研究過程中，患者可能會取得進展，特別是在安慰劑組中，並且患者將無法在研究中的短時間段時間點停止補充氧氣。

Now let's review the secondary endpoints. SGRQ was resulted in IMPALA and as I mentioned before, with the use IMPALA 2 as well. SGRQ have 3 components, which are symptoms, activity and impact. SGRQ total score which will be a secondary endpoint and IMPALA 2 - all the components. They should make a total for the secondary endpoint of IMPALA, the domestic and a nice separation between the daily dose and regimen and procedure. And in IMPALA 2, we separator outer structure activity as another secondary endpoint, as it is most applicable to aPAP and it also shows a nice separation in IMPALA.

現在讓我們回顧一下次要終點。SGRQ 是在 IMPALA 中產生的，正如我之前提到的，也使用 IMPALA 2。SGRQ 有 3 個組成部分，即症狀、活動和影響。SGRQ 總分將作為次要終點和 IMPALA 2 - 所有組件。他們應該為 IMPALA 的次要終點、國內和每日劑量、方案和程序之間的良好分離做一個總和。在 IMPALA 2 中，我們將外部結構活動作為另一個次要終點進行分離，因為它最適用於 aPAP，並且在 IMPALA 中也顯示出良好的分離效果。

As we mentioned a function, the IMPALA 2 study to assess capacity using a treadmill test as a secondary endpoint. The treadmill test is a standardized test for determining improvement in excise capacity to gradually increasing the speed and slope of a treadmill until the patient is stressed. In contrast, the IMPALA study used 6-minute walk distance as a key secondary endpoint, which showed in the molecule trend, but it wasn't physical (inaudible). Exercise treadmill test is expected to be discriminatory because patients are stretched to the functional capacity. Whole lung lavage is an important aspect in the treatment of aPAP patients. The first IMPALA study measured whole lung lavage as a key secondary endpoint. The percentage of patients who had whole lung lavage in IMPALA at about 10%.

正如我們提到的一個功能，IMPALA 2 研究使用跑步機測試作為次要終點來評估能力。跑步機測試是一種標準化測試，用於確定運動能力的改善，以逐漸增加跑步機的速度和坡度，直到患者感到壓力。相比之下，IMPALA 研究使用 6 分鐘步行距離作為關鍵的次要終點，它顯示在分子趨勢中，但它不是物理的（聽不清）。預計運動平板試驗具有歧視性，因為患者被拉伸到功能能力。全肺灌洗是治療 aPAP 患者的一個重要方面。第一項 IMPALA 研究將全肺灌洗作為一個關鍵的次要終點。在 IMPALA 中進行全肺灌洗的患者百分比約為 10%。

In the IMPALA 2 study, we will record whole lung lavage as an exploratory end point to be double blind treatment period in IMPALA 2. We expect to have more patients under the whole lung lavage to compare between the drug and placebo. The IMPALA 2 will have a total of 150 patients in 2 treatment arms, with 80 patients in each. In contrast, the IMPALA study had a total of 138 patients in 3 treatment arms with about 48 patients in each. The IMPALA 2 study will only have one active treatment arm, and once-daily dosing regimen. Because in policy should better treatment affect the one statement dose regiment compared to the intermittent dosing regimen.

在 IMPALA 2 研究中，我們將記錄全肺灌洗作為 IMPALA 2 雙盲治療期的探索性終點。我們預計會有更多的患者接受全肺灌洗，以比較藥物和安慰劑。IMPALA 2 將在 2 個治療組中共有 150 名患者，每組 80 名患者。相比之下，IMPALA 研究在 3 個治療組中共有 138 名患者，每組約 48 名患者。IMPALA 2 研究將只有一個活性治療組和每日一次的給藥方案。因為在政策上，與間歇給藥方案相比，應該更好地影響單劑量方案的治療。

Operationally, IMPALA 2 is conducted at approximately 50 sites across nearly 15 countries, including the U.S., Canada, Japan, South Korea, and select countries of Europe. It plans to try and open of all study centers as close together as possible. In contrast, IMPALA was conducted at 32 sites across 18 countries. However, study centers are not activated at once. And consequently, patient enrollment ramped up gradually over time. Once all IMPALA study centers are open, including sites in the U.S. that were added later. Peak enrollment rate for approximately 8 to 10 patients per month.

在運營方面，IMPALA 2 在近 15 個國家/地區的大約 50 個地點進行，包括美國、加拿大、日本、韓國和部分歐洲國家/地區。它計劃嘗試盡可能靠近地開放所有研究中心。相比之下，IMPALA 是在 18 個國家/地區的 32 個地點進行的。但是，學習中心不會立即啟動。因此，隨著時間的推移，患者登記逐漸增加。一旦所有 IMPALA 研究中心都開放，包括後來添加的美國站點。每月約 8 至 10 名患者的峰值註冊率。

Given that we plan to try and opening of all IMPALA 2 study sites around the same time. 20 of which will be in the U.S. and Canada. And constantly our experience and relationships with many of the centers that conducted the IMPALA study. We believe we can enroll IMPALA 2 with greater efficiency. We will not be guiding today of the timing for enrollment completion. Once all the centers have initiated and started recruiting, we will be in a better position to answer questions in this regard. There are no approved competent progress for aPAP in any country, not under any company clinical trials, which is favorable for IMPALA recruitment. Additionally, we are stalking the IMPALA-X study, the continuation of the IMPALA study where approximately 60 patients are treated with Molgradex 300 micrograms of intermittent weekly regimen. Some patients come from IMPALA-X may be eligible for the IMPALA 2 study.

鑑於我們計劃嘗試在大約同一時間開放所有 IMPALA 2 研究站點。其中 20 個將在美國和加拿大。以及我們與許多進行 IMPALA 研究的中心的經驗和關係。我們相信我們可以更高效地註冊 IMPALA 2。我們今天不會指導完成註冊的時間。一旦所有中心都啟動並開始招募，我們將能夠更好地回答這方面的問題。aPAP在任何國家都沒有批准的合格進展，沒有任何公司臨床試驗，這有利於IMPALA招募。此外，我們正在跟踪 IMPALA-X 研究，這是 IMPALA 研究的延續，其中大約 60 名患者接受了 Molgradex 300 微克的間歇性每周治療方案。一些來自 IMPALA-X 的患者可能有資格參加 IMPALA 2 研究。

Over the last few months, we have had productive conversations with regulators in the U.S. and Europe, which have culminated in IMPALA study design that we are confident. Constructive discussions with the Japanese regulators ongoing, and we will keep you updated on most of the matters in this regard.

在過去的幾個月裡，我們與美國和歐洲的監管機構進行了富有成效的對話，最終得出了我們有信心的 IMPALA 研究設計。與日本監管機構的建設性討論正在進行中，我們將讓您了解這方面的大部分事宜。

As I end my remarks, I want to mention that we are pleased to see that this rare disease is in the mind of the FDA as well. The agency and partnership with the PAP foundation as a national organization for rare disorders, recently hosted a patient listening session focused on PAP. These sessions for the agency to engage directly with patients or good advocates, on what it is like to low this rare disease, and to incorporate information from this session into their content. Patients are at the heart of a lot of research. And we will happy to hear that people living with PAP could share the powerful stories with regulators. It is those stories that continually flow our drive to -- for the treatment of this serious decease.

在我結束髮言時，我想提一下，我們很高興看到這種罕見疾病也在 FDA 的考慮範圍之內。該機構和 PAP 基金會的合作夥伴關係是一個全國性的罕見疾病組織，最近舉辦了一場以 PAP 為重點的患者聆聽會議。這些會議讓該機構直接與患者或優秀倡導者接觸，了解降低這種罕見疾病的情況，並將本次會議的信息納入其內容。患者是許多研究的核心。我們很高興聽到 PAP 患者可以與監管機構分享這些有影響力的故事。正是這些故事不斷推動著我們去治療這種嚴重的疾病。

Thank you for your time today. I will hand over the call to Dave who will provide you with a financial update.

謝謝你今天的時間。我會將電話轉給 Dave，他將為您提供最新的財務信息。

Thanks, Badrul. And hello, everyone. Let me begin by updating you on our cash position. As of June 30, 2020, we had cash, cash equivalents and short-term investments were approximately 100 million with 25 million of debt. Under our current operating plan, including the anticipated second tranche of approximately 46 million from our December financing, we believe we have sufficient capital to fund our planned operations.

謝謝，巴德魯。大家好。讓我首先向您介紹我們的現金狀況。截至 2020 年 6 月 30 日，我們擁有現金、現金等價物和短期投資約 1 億，負債 2500 萬。根據我們目前的運營計劃，包括我們 12 月融資的預期第二筆約 4600 萬歐元，我們相信我們有足夠的資金來資助我們的計劃運營。

With respect to our second quarter results, Savara's net loss attributable to common stockholders for the 3 months ended June 30, 2020, was 9.4 million for $0.16 per share, compared with a net loss of 21.9 million or $0.57 per share for the 3 months into June 30, 2019.

關於我們的第二季度業績，Savara 截至 2020 年 6 月 30 日止三個月的歸屬於普通股股東的淨虧損為 940 萬美元，每股虧損 0.16 美元，而前三個月的淨虧損為 2190 萬美元，每股虧損 0.57 美元2019 年 6 月 30 日。

Research and development expenses decreased by 4.4 million or 42% to 6.1 million for the 3 months ended June 30, 2020, compared to 10.5 million for the 3 months ended June 30, 2019. The decrease was primarily related to 2.8 million in lower available study costs due to the wrap up of enrollment, the transition to processing the last patient out along with database management lock and reduction in related CMC and clinical operations activities. Additionally, there was a decrease of approximately $1.6 million associated with our Molgradex for aPAP program as study activities associated with IMPALA and IMPALA X are wrapping up. And we are now preparing for the initiation of IMPALA 2.

截至 2020 年 6 月 30 日止三個月，研發費用減少 440 萬或 42% 至 610 萬，而截至 2019 年 6 月 30 日止三個月則為 1,050 萬。這一減少主要與 280 萬美元的可用研究成本降低有關，原因是註冊結束、向處理最後一名患者的過渡以及數據庫管理鎖定以及相關 CMC 和臨床操作活動的減少。此外，隨著與 IMPALA 和 IMPALA X 相關的研究活動即將結束，與我們的用於 aPAP 的 Molgradex 計劃相關的費用減少了約 160 萬美元。我們現在正在準備啟動 IMPALA 2。

General and administrative expenses decreased by $1.1 million, or 26% to $3.1 million for the 3 months ended June 30, 2020, for $4.2 million for the 3 months ended June 30, 2019. This decrease was mainly due to reduced commercial activities for the 3 months ended June 30, 2020.

截至 2020 年 6 月 30 日止三個月，一般及行政費用減少 110 萬美元或 26% 至 310 萬美元，截至 2019 年 6 月 30 日止三個月為 420 萬美元。這一減少主要是由於截至 2020 年 6 月 30 日止三個月的商業活動減少。

I will conclude my remarks by reiterating that our cash position enabled us to execute upon our strategy and continue to work on our study initiatives.

我將通過重申我們的現金狀況使我們能夠執行我們的戰略並繼續致力於我們的研究計劃來結束我的發言。

Now I will hand the call back to Rob.

現在我將把電話交還給 Rob。

Thank you, Dave. And before we close the call today, I wanted to share my enthusiasm for the future, especially as it relates to our aPAP program and let me just tell you a few reasons why. First, the FDA describes his breakthrough therapy designation from Molgradex in aPAP. In addition, the mechanism of action for the drug in aPAP is well understood and the data from IMPALA study demonstrate the drug has beneficial effects.

謝謝你，戴夫。在我們今天結束電話會議之前，我想分享我對未來的熱情，尤其是與我們的 aPAP 計劃相關的熱情，讓我告訴您幾個原因。首先，FDA 在 aPAP 中描述了他從 Molgradex 獲得的突破性治療指定。此外，該藥物在 aPAP 中的作用機制已廣為人知，IMPALA 研究的數據表明該藥物具有有益作用。

We are in a great position with this program, we believe in Molgradex and came wells in the patients. And the investors on bank capital tell us they also believe in it. And importantly, our new CMO, Badrul, who ran the FDA division responsible for overseeing such therapies, also (inaudible). With the ability to apply key learnings from the IMPALA 2 protocol, and are incorporating input from the FDA and EMA into the study design. We believe IMPALA 2 has a high likelihood of success. We are strongly positioned to improve on the tasks and exceed expectations in the future. We are grateful for the loyalty and the patience and support of our current investors. Given what we have with IMPALA 2 a drug that is believed to work in a study that's about start. And not to even mention our other phase III top line programs. We feel the Savara investment thesis is strong and poised to grow stronger still.

我們在這個項目中處於有利地位，我們相信 Molgradex 並且在患者中表現良好。銀行資本的投資者告訴我們，他們也相信這一點。重要的是，我們的新首席營銷官 Badrul 負責監督此類療法，他負責管理 FDA 部門（聽不清）。能夠應用從 IMPALA 2 協議中學到的關鍵知識，並將 FDA 和 EMA 的輸入納入研究設計。我們相信 IMPALA 2 成功的可能性很高。我們有能力在未來改進任務並超越預期。我們感謝現有投資者的忠誠、耐心和支持。鑑於我們擁有的 IMPALA 2 藥物被認為在一項即將開始的研究中起作用。更不用說我們的其他 III 期頂級項目。我們認為 Savara 的投資論點很強大，而且有望變得更加強大。

As always, we thank you for your support. And we look forward to keeping you updated as milestones met. On that note, I would like to inform you that we will be transitioning away from quarterly call such as this way. And instead, hosting web cross supports throughout the year as needed. And with a frequency that is aligned with our news flow. We will clearly continue to disclose our quarterly updates for a press release. And we will always alert you to any webcast course one week in advance so that you can plan accordingly.

一如既往，我們感謝您的支持。我們期待在達到里程碑時讓您了解最新情況。關於這一點，我想通知您，我們將不再以這種方式進行季度電話會議。相反，根據需要全年託管網絡交叉支持。並且頻率與我們的新聞流一致。我們將明確地繼續披露我們的新聞稿季度更新。我們將始終提前一周提醒您參加任何網絡直播課程，以便您做出相應的計劃。

Now I will ask Jason to open up call for analysts' questions.

現在我將請 Jason 公開徵求分析師的問題。

(Operator Instructions) First question is from Michael Higgins from Ladenburg Thalmann.

（操作員說明）第一個問題來自 Ladenburg Thalmann 的 Michael Higgins。

This is Edward on for Michael. I appreciate you taking the question and congrats on finalizing the design from IMPALA 2, just a couple questions on the design. I'm wondering you talked about 20 sites opening up in the US and Canada. I heard that correctly. So just wondering how many you expect to be spread through the EU and Asia? And then in terms of the timing for releasing of the data, or the data itself, I'm just wondering with the EMA or the FDA will require the full 24-week or the full 48- week data before you are allowed start to put together something like an NDA.

這是邁克爾的愛德華。感謝您提出問題並祝賀您完成了 IMPALA 2 的設計，只是關於設計的幾個問題。我想知道你談到了在美國和加拿大開設的 20 個網站。我沒聽錯。所以只是想知道您希望通過歐盟和亞洲傳播多少？然後就發布數據的時間或數據本身而言，我只是想知道 EMA 或 FDA 是否需要完整的 24 週或完整的 48 週數據，然後才能開始投放一起像保密協議一樣。

Our size in U.S. and Canada will be 2020 approximately. The total number is size is approximately 15. And the spread, we'll have about 8 or 9 countries in the EU. And also some sites in Japan and Korea. The spread will be more or less even across the EU and Japan and Korea. So exactly global scale oxides. As far as the 24-weeks versus 48-weeks for the submission of an application to the FDA or the EMA. The 48-weeks is the placebo controlled time period. So if submission will happen with the readout of the 48-weeks data.

我們在美國和加拿大的規模大約是 2020 年。總數約為 15 個。而傳播，我們將在歐盟擁有大約 8 或 9 個國家。還有日本和韓國的一些網站。整個歐盟、日本和韓國的傳播或多或少也會如此。所以正是全球規模的氧化物。至於向 FDA 或 EMA 提交申請的時間是 24 週還是 48 週。48 周是安慰劑控制的時間段。因此，如果提交將在讀出 48 週數據時發生。

Okay. And in terms of the aPAP asset, I'm wondering if when you anticipate having those FTA discussions and whether they be impacted by COVID. And you anticipate running this trial in tandem with IMPALA 2 or would you prefer to wait until you get that data come in?

好的。就 aPAP 資產而言，我想知道您是否預計何時會進行這些 FTA 討論以及它們是否會受到 COVID 的影響。您希望與 IMPALA 2 一起運行此試驗，還是您更願意等到獲得數據？

Let me answer that one. This is Rob. So we haven't guided yet. But our internal goal is to have those discussions with the FDA deployment as soon as feasible. Hopefully this year, if not early next year. And then, as far as running the study in parallel, yes, we believe we will do those in parallel. Once that study is up and - once the study design has been set. And we have done only internal planning from a clinical operations standpoint, they will most likely be an overlap.

讓我回答那個。這是羅布。所以我們還沒有指導。但我們的內部目標是盡快與 FDA 部署進行這些討論。希望今年，如果不是明年初。然後，就並行進行研究而言，是的，我們相信我們會並行進行這些研究。一旦該研究完成並且 - 一旦研究設計已經確定。而且我們只從臨床操作的角度進行了內部規劃，它們很可能會重疊。

(Operator Instructions) There are no more questions in the queue. I will now hand the call over to Anne Erickson to read any questions submitted through e-mail.

（操作員說明）隊列中沒有更多問題。我現在將把電話轉給 Anne Erickson，讓她閱讀通過電子郵件提交的任何問題。

One question submitted. So one concern is involved with the positive impact whole lung lavage had on the AA ingredient. Is that also the case with DLCO?

提交了一個問題。因此，一個問題涉及全肺灌洗對 AA 成分的積極影響。DLCO也是這樣嗎？

I'm going to take this question. We have said that Molgradex still benefit a patient even after undergoing a whole lung lavage. Contract the general belief that whole lung lavage improves gas transfer. Such an effect was not shown in the IMPALA study. Perhaps it is due to the lack disease severity of the patient's syndrome. Given enrolled patients in IMPALA 2 with similar disease severity, as was an IMPALA. In IMPALA, there was a noted improvement on the -- surface change after a whole lung lavage. However, the improvement was for limited duration, and the patient's disease progress. We anticipate that to change in IMPALA 2.

我要回答這個問題。我們已經說過，即使在接受全肺灌洗後，Molgradex 仍然對患者有益。相信全肺灌洗可以改善氣體轉移的普遍觀點。IMPALA 研究中未顯示這種效果。也許是由於缺乏患者綜合症的疾病嚴重程度。鑑於在 IMPALA 2 中登記的患者俱有與 IMPALA 相似的疾病嚴重程度。在 IMPALA 中，全肺灌洗後的表面變化有顯著改善。然而，改善的持續時間有限，並且患者的疾病進展。我們預計這會在 IMPALA 2 中改變。

Thank you, Jason. Are there any other questions?

謝謝你，傑森。還有其他問題嗎？

No, there are no more questions in the queue.

不，隊列中沒有更多問題。

Okay. Thank you, Jason. Thank you, everybody, for taking the time to join our call. I appreciate it. Take care.

好的。謝謝你，傑森。謝謝大家抽出時間加入我們的電話會議。我很感激。小心。

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

會議現已結束。感謝您參加今天的演講。您現在可以斷開連接。