Tempest Therapeutics Inc (TPST) 2017 Q4 法說會逐字稿

Good afternoon, ladies and gentlemen, thank you for standing by. Welcome to OvaScience's conference call to discuss the company's Fourth Quarter and Year-end 2017 Earnings Results. (Operator Instructions) I would like to remind everyone that this conference call is being recorded.

女士們先生們，下午好，感謝你們的支持。歡迎參加 OvaScience 的電話會議，討論公司 2017 年第四季度和年底的收益結果。（操作員說明）我想提醒大家，這個電話會議正在錄製中。

I will now turn the conference over to Jennifer Viera with OvaScience. Please go ahead.

我現在將會議轉交給 OvaScience 的 Jennifer Viera。請繼續。

Good afternoon, and thank you for joining us on today's call to discuss OvaScience's financial results for the fourth quarter and year-ended December 31, 2017.

下午好，感謝您參加今天的電話會議，討論 OvaScience 截至 2017 年 12 月 31 日第四季度和全年的財務業績。

With me today are Dr. Christopher Kroeger, our Chief Executive Officer; and Jonathan Gillis, our Senior Vice President of Finance.

今天和我在一起的是我們的首席執行官 Christopher Kroeger 博士；和我們的財務高級副總裁 Jonathan Gillis。

Our discussions during this conference call will include forward-looking statements. Actual results could differ materially from these forward-looking statements. Please see our press release issued this afternoon and our annual report on Form 10-K for important risk factors that could cause our actual results to differ materially from those projected or suggested in the forward-looking statements.

我們在本次電話會議期間的討論將包括前瞻性陳述。實際結果可能與這些前瞻性陳述存在重大差異。請參閱我們今天下午發布的新聞稿和我們關於 10-K 表格的年度報告，了解可能導致我們的實際結果與前瞻性陳述中預測或建議的結果存在重大差異的重要風險因素。

We undertake no obligation to update or revise the information provided on this call as a result of new information or future results or developments.

我們不承擔因新信息或未來結果或發展而更新或修改本次電話會議上提供的信息的義務。

We'll begin first with Chris, who will discuss recent business highlights, followed by John, who will discuss our financial results for the fourth quarter and full year 2017.

我們將首先由 Chris 開始，他將討論最近的業務亮點，然後是 John，他將討論我們 2017 年第四季度和全年的財務業績。

After our remarks, we'll open the call for Q&A.

在我們的評論之後，我們將打開問答電話。

Now I'll turn the call over to Chris. Chris?

現在我會把電話轉給克里斯。克里斯？

Thank you, Jennifer, and good afternoon, everyone. Thank you for joining us on today's call to discuss OvaScience and our recent progress.

謝謝你，詹妮弗，大家下午好。感謝您參加今天的電話會議，討論 OvaScience 和我們最近的進展。

2017 was an important year for OvaScience, marked by a careful assessment of our strategic priorities and a focus on charting the most efficient data-driven paths for the development of our clinical and preclinical stage treatments.

2017 年對 OvaScience 來說是重要的一年，我們仔細評估了我們的戰略重點，並專注於為我們的臨床和臨床前階段治療的開發製定最有效的數據驅動路徑。

We're entering 2018 with a clear direction and a firm commitment to our R&D-focused business strategy.

進入 2018 年，我們將帶著明確的方向和對以研發為中心的業務戰略的堅定承諾。

Following recent advancements with OvaPrime and OvaTure, which I will review shortly, I'm confident that we're positioned to achieve significant progress with both programs in the year ahead.

繼 OvaPrime 和 OvaTure 最近取得的進展之後，我將很快對其進行回顧，我相信我們有能力在未來一年通過這兩個項目取得重大進展。

We continue to believe in the tremendous potential of egg precursor or EggPC cells to revolutionize the treatment landscape for female fertility.

我們仍然相信卵子前體細胞或 EggPC 細胞具有徹底改變女性生育治療前景的巨大潛力。

I also want to emphasize that while we have made meaningful changes to our company in recent months, our mission remains unchanged. Our goal is to translate the breakthrough discovery of EggPC cells into transformative treatments for women's fertility.

我還想強調，雖然我們在最近幾個月對公司進行了有意義的改變，但我們的使命沒有改變。我們的目標是將 EggPC 細胞的突破性發現轉化為女性生育能力的變革性療法。

I'll begin today by discussing OvaPrime, our potential fertility treatment that could help a woman who makes too few or no eggs.

今天我將首先討論 OvaPrime，這是我們潛在的生育治療方法，可以幫助產卵過少或不產卵的女性。

With OvaPrime, we isolate a women's EggPC cells from a niche within her ovary with they're quiescent and reposition them so that they can receive the appropriate signals to develop into mature eggs.

借助 OvaPrime，我們將女性的 EggPC 細胞從處於靜止狀態的卵巢壁龕中分離出來，並重新定位它們，以便它們能夠接收到適當的信號以發育成成熟的卵子。

OvaPrime is designed to address the substantial unmet need among women suffering from primary ovarian insufficiency, or POI, and poor ovarian response or POR.

OvaPrime 旨在解決患有原發性卵巢功能不全 (POI) 和卵巢反應不良 (POR) 的女性中大量未滿足的需求。

For women with POI or POR, in vitro fertilization or IVF is largely ineffective. Many patients with POI or POR resort to a donor egg or adoption, with some giving up on having a child altogether.

對於患有 POI 或 POR 的女性，體外受精或 IVF 在很大程度上是無效的。許多患有 POI 或 POR 的患者求助於捐贈卵子或領養，其中一些患者完全放棄了生育。

OvaPrime has the potential to address this need by restoring egg production and thereby increasing the likelihood of a successful pregnancy.

OvaPrime 有可能通過恢復產卵量來滿足這一需求，從而增加成功懷孕的可能性。

In January, we reported initial safety data from our single-center prospective blinded and placebo-controlled Phase I clinical trial of OvaPrime in women with POI or POR. Among the first 20 patients who were evaluated for safety 6 months after EggPC cells reintroduction, there were no treatment-related serious adverse events and no adverse events or AEs related to the EggPC cells.

1 月，我們報告了 OvaPrime 在患有 POI 或 POR 的女性中進行的單中心前瞻性盲法和安慰劑對照 I 期臨床試驗的初步安全性數據。在重新引入 EggPC 細胞後 6 個月進行安全性評估的前 20 名患者中，沒有發生與治療相關的嚴重不良事件，也沒有與 EggPC 細胞相關的不良事件或 AE。

There were 7 mild AEs, 4 of which were deemed unrelated to OvaPrime and 3 of which were related to the standard laparoscopic procedure.

有 7 起輕微的 AE，其中 4 起被認為與 OvaPrime 無關，3 起與標準腹腔鏡手術有關。

No patients discontinued treatment because of an AE. The mean duration of follow up among these 20 patients was 9 months. Following the safety readout, we closed enrollments in this trial at 81 patients for a modified intent to treat population of 58.

沒有患者因 AE 而停止治療。這 20 名患者的平均隨訪時間為 9 個月。在安全性讀數之後，我們關閉了該試驗的 81 名患者的入組，以修改意向治療人群 58 人。

We expect to announce 6-month safety data for all patients by year-end 2018 and to read out initial secondary endpoints for all patients by the end of the third quarter of 2019. However, based on preliminary blinded data, we do not expect this trial to produce strong signals on any of our secondary endpoints. We believe this may be due to the delivery of a suboptimal EggPC cells dose.

我們預計將在 2018 年年底前公佈所有患者的 6 個月安全數據，並在 2019 年第三季度末公佈所有患者的初始次要終點。然而，根據初步的盲法數據，我們預計該試驗不會在我們的任何次要終點上產生強烈信號。我們認為這可能是由於提供了次優的 EggPC 細胞劑量。

To address this, we have significantly improved our cell processing and thaw techniques in recent months. Specifically, we have enhanced the yield impurity of the EggPC cells we are repositioning and believe we now have a process that will maximize the delivered dose.

為了解決這個問題，我們在最近幾個月顯著改進了細胞處理和解凍技術。具體來說，我們已經提高了我們正在重新定位的 EggPC 細胞的產量雜質，並且相信我們現在有一個可以最大化遞送劑量的過程。

Together, these events will allow us to consistently administer a much higher number of EggPC cells per treatment in the OvaPrime study. These enhancements in cell processing and yield will also be applied to AUGMENT and OvaTure, as appropriate.

總之，這些事件將使我們能夠在 OvaPrime 研究中每次治療持續施用更多數量的 EggPC 細胞。這些細胞處理和產量方面的改進也將酌情應用於 AUGMENT 和 OvaTure。

We're now focusing on advancing OvaPrime into a new Phase 1b/2a clinical trial, which will evaluate the safety and tolerability of administering a higher number of EggPC cells per treatment.

我們現在專注於將 OvaPrime 推進到新的 1b/2a 期臨床試驗，該試驗將評估每次治療給予更多 EggPC 細胞的安全性和耐受性。

Our decision to close enrollments in our Phase I trial and to move forward with the Phase 1b/2a trial of OvaPrime was driven by both the encouraging safety results in our Phase I trial and the recent improvements in cell processing and thaw techniques I just described.

我們決定結束 I 期試驗的註冊並推進 OvaPrime 的 1b/2a 期試驗，是由於我們 I 期試驗中令人鼓舞的安全性結果以及我剛才描述的細胞處理和解凍技術的最新改進。

We believe that these improved cell processing techniques will yield a more robust signal on our secondary endpoints.

我們相信，這些改進的細胞處理技術將在我們的次要終點上產生更強大的信號。

We are currently conducting a series of preclinical animal studies to better understand the characteristics of EggPC cells as part of the OvaPrime treatment and the impact of improved EggPC cell yield and purity on efficacy.

我們目前正在進行一系列臨床前動物研究，以更好地了解作為 OvaPrime 治療一部分的 EggPC 細胞的特性，以及提高 EggPC 細胞產量和純度對功效的影響。

Findings from these studies will allow us to further optimize the design of our Phase 1b/2a trial to provide meaningful insights regarding the safety in secondary endpoints of OvaPrime.

這些研究的結果將使我們能夠進一步優化 1b/2a 期試驗的設計，以提供有關 OvaPrime 次要終點安全性的有意義的見解。

We plan to provide an update on our development plan and begin enrollment in the second half of 2018.

我們計劃更新我們的發展計劃並在 2018 年下半年開始招生。

Now let me turn to OvaTure. OvaTure is our potential therapy that eliminates the need for hormone stimulation. With OvaTure, a woman's EggPC cells are isolated from her ovary and matured in vitro into healthy, fertilizable eggs.

現在讓我談談 OvaTure。OvaTure 是我們的潛在療法，無需激素刺激。通過 OvaTure，女性的 EggPC 細胞從她的卵巢中分離出來，並在體外成熟為健康、可受精的卵子。

We've taken important steps forward in our efforts to produce mature fertilized bovine and human eggs by optimizing our cell isolation, cell sorting and cell culture strategies.

通過優化我們的細胞分離、細胞分选和細胞培養策略，我們在努力生產成熟的牛和人受精卵方面邁出了重要的一步。

As we discussed at the JPMorgan conference in January, we're exploring different subcultures systems that allow for even further maturation of eggs.

正如我們在 1 月份的摩根大通會議上討論的那樣，我們正在探索不同的亞培養系統，這些系統可以讓卵子進一步成熟。

Recently, in conjunction with one of our academic partners, we developed a human subculture system that has produced much larger eggs with morphologic features that appear to be more mature.

最近，與我們的一個學術合作夥伴一起，我們開發了一種人類亞培養系統，該系統產生了更大的卵，其形態特徵似乎更成熟。

Specifically, these EggPC cell-derived eggs are approximately 100 microns in size and have a thicker zona pellucida and are surrounded by a cumulus-oocyte complex or COC.

具體來說，這些 EggPC 細胞衍生的卵子大小約為 100 微米，透明帶較厚，周圍環繞著卵丘-卵母細胞複合體或 COC。

The COC is a series of cumulus or support cells that have aggregated around the cell and are typical in endogenous developing follicle.

COC 是一系列聚集在細胞周圍的卵丘或支持細胞，是內源性發育卵泡的典型特徵。

We're encouraged by these data and are pushing forward on the subculture strategy to improve its consistency and yield. We continue to work with our academic partners in Europe to receive authorization to fertilize these human EggPC cell-derived eggs.

我們對這些數據感到鼓舞，並正在推進亞文化戰略以提高其一致性和產量。我們繼續與我們在歐洲的學術合作夥伴合作，以獲得授權使這些人類 EggPC 細胞衍生的卵子受精。

As part of our strategy to progress the OvaTure program, we terminated our exclusive channel collaboration agreements with Intrexon.

作為推進 OvaTure 計劃戰略的一部分，我們終止了與 Intrexon 的獨家渠道合作協議。

This decision was based on the belief that we can most effectively develop OvaTure by leveraging internal capabilities and engaging with contract research organizations and select academic institutions that have specific complementary capabilities.

這一決定是基於這樣一種信念，即我們可以通過利用內部能力並與合同研究組織合作並選擇具有特定互補能力的學術機構來最有效地開發 OvaTure。

We do not expect the termination of this collaboration to adversely impact or slow OvaTure development. This decision also reflects our confidence in the leadership of Dr. James Lillie, who we appointed as Chief Scientific Officer earlier this year. He brings more than 25 years of cellular biology and biochemistry experience and will lead our preclinical R&D efforts.

我們預計此次合作的終止不會對 OvaTure 開發產生不利影響或減緩。這一決定也反映了我們對今年早些時候被任命為首席科學官的 James Lillie 博士的領導能力的信心。他擁有超過 25 年的細胞生物學和生物化學經驗，將領導我們的臨床前研發工作。

Jim joins us from Sanofi Genzyme, where he worked for 14 years, mostly recently as Vice President of In Vitro Biology. Prior to Genzyme, Jim held roles of increasing responsibility at Millennium Pharmaceuticals.

Jim 從 Sanofi Genzyme 加入我們，他在那里工作了 14 年，最近擔任體外生物學副總裁。在加入 Genzyme 之前，Jim 在 Millennium Pharmaceuticals 擔任越來越重要的職務。

We're thrilled to have Jim on board, and I look forward to working closely with him as we continue to advance OvaPrime and OvaTure.

我們很高興 Jim 加入，我期待著與他密切合作，繼續推進 OvaPrime 和 OvaTure。

Now I'll turn to AUGMENT, our fertility treatment designed to improve egg fertilization efficiency and IVS success rates. With AUGMENT, we isolate mitochondria from a woman's own EggPC cells and inject them into the egg during IVF. We're pleased to offer AUGMENT to patients in Japan through an exclusive license to IVF Japan Group.

現在我將轉向 AUGMENT，我們的生育治療旨在提高卵子受精效率和 IVS 成功率。通過 AUGMENT，我們從女性自身的 EggPC 細胞中分離出線粒體，並在 IVF 期間將它們注射到卵子中。我們很高興通過 IVF Japan Group 的獨家許可向日本患者提供 AUGMENT。

The license agreement, which is relatively cost neutral, is helping us generate additional AUGMENT outcomes data to better inform the target patient profile for this treatment.

相對成本中性的許可協議正在幫助我們生成額外的 AUGMENT 結果數據，以更好地告知目標患者概況以進行這種治療。

Finally, I'll end by discussing the recent corporate changes, namely our corporate restructuring in January. After a careful review of our business, we found that our R&D-focused strategy could be executed most efficiently by a smaller, more versatile organization. While the decision to reduce our workforce was difficult, this corporate restructuring streamlines our operations, reduces our cost structure and will enable us to reach key inflection points in our OvaPrime trials and OvaTure program without additional funding.

最後，我將討論最近的公司變化，即 1 月份的公司重組。在仔細審查我們的業務後，我們發現我們以研發為中心的戰略可以由規模更小、功能更全面的組織最有效地執行。雖然裁員的決定很困難，但這次公司重組簡化了我們的運營，降低了我們的成本結構，並使我們能夠在沒有額外資金的情況下達到 OvaPrime 試驗和 OvaTure 計劃的關鍵轉折點。

I firmly believe that we're now right-sized and appropriately resourced to best execute toward our goals.

我堅信，我們現在規模合適，資源充足，可以最好地實現我們的目標。

With that, I will now turn the call over to John, who will review our financial results from the fourth quarter and 2017. John?

有了這個，我現在將把電話轉給約翰，他將審查我們第四季度和 2017 年的財務業績。約翰？

Thank you, Chris, and good afternoon, everyone. As you know, we have worked hard over the last year to align our organization with our R&D-focused strategy.

謝謝克里斯，大家下午好。如您所知，我們在過去的一年裡一直在努力使我們的組織與我們以研發為中心的戰略保持一致。

Our progress toward this goal strengthens our ability to execute our corporate strategy and is reflected in our financial results for the fourth quarter and year-ended 2017.

我們在實現這一目標方面取得的進展增強了我們執行企業戰略的能力，並反映在我們 2017 年第四季度和年底的財務業績中。

Research and development expenses for the quarter ended December 31, 2017, excluding restructuring cost, were $3.6 million compared to $4.7 million for the same period in 2016.

截至 2017 年 12 月 31 日止季度的研發費用（不包括重組費用）為 360 萬美元，而 2016 年同期為 470 萬美元。

R&D cost for the full year ended December 31, 2017, excluding restructuring costs were $18.3 million compared to $21.6 million for the same period in 2016. This quarter-over-quarter and year-over-year decrease resulted mainly from reduced employee-related costs, including stock-based compensation expense, travel and lab supplies as we executed our refined R&D-focused strategy during 2017.

截至 2017 年 12 月 31 日的全年研發成本（不包括重組成本）為 1830 萬美元，而 2016 年同期為 2160 萬美元。這一環比和同比下降主要是由於我們在 2017 年執行了以研發為重點的完善戰略時，與員工相關的成本減少，包括基於股票的補償費用、差旅和實驗室用品。

We expect R&D expense to increase as a percentage of our overall cost as we continue to focus our efforts on advancing our OvaPrime and OvaTure treatments.

隨著我們繼續集中精力推進我們的 OvaPrime 和 OvaTure 治療，我們預計研發費用占我們總成本的百分比將會增加。

Selling, general and administrative expenses for the quarter, excluding restructuring costs, were $4.8 million compared to $10.9 million for the same period in 2016.

本季度的銷售、一般和行政費用（不包括重組費用）為 480 萬美元，而 2016 年同期為 1090 萬美元。

SG&A expenses for the full year 2017, excluding restructuring costs, were $27.7 million compared to $49.2 million for the full year 2016.

2017 年全年的 SG&A 費用（不包括重組費用）為 2770 萬美元，而 2016 年全年為 4920 萬美元。

This quarter-over-quarter and year-over-year decrease was primarily driven by reduced employee-related costs, including stock-based compensation expense, reduced travel, facilities and other expenses as we restructured our operations to refocus on the continued development of OvaPrime and OvaTure. We expect SG&A expense to decrease as we execute our corporate plan.

這一環比和同比下降主要是由於我們重組業務以重新專注於 OvaPrime 的持續發展而減少的員工相關成本，包括基於股票的補償費用、減少差旅、設施和其他費用。和 OvaTure。我們預計 SG&A 費用會隨著我們執行公司計劃而減少。

Net loss for the quarter was $8.5 million or $0.24 per share as compared to a net loss of $22.6 million or $0.64 per share for the same period in 2016. Net loss for the full year 2017 was $51 million or $1.43 per share compared to a net loss of $82.3 million or $2.56 per share for the same period in 2016.

本季度淨虧損為 850 萬美元或每股 0.24 美元，而 2016 年同期淨虧損為 2260 萬美元或每股 0.64 美元。2017 年全年淨虧損為 5100 萬美元或每股 1.43 美元，而 2016 年同期淨虧損為 8230 萬美元或每股 2.56 美元。

The net loss for the quarter and year-ended 2017 includes restructuring cost of $0.2 million and $4 million, respectively, compared to $5.4 million for the same period in 2016.

截至 2017 年季度和年度的淨虧損包括分別為 20 萬美元和 400 萬美元的重組成本，而 2016 年同期為 540 萬美元。

As of December 31, 2017, we had cash, cash equivalents and short-term investments of $67.2 million compared to $114.4 million as of December 31, 2016.

截至 2017 年 12 月 31 日，我們擁有現金、現金等價物和短期投資 6720 萬美元，而截至 2016 年 12 月 31 日為 1.144 億美元。

Our cash, cash equivalents and short-term investment balance will be used to support our R&D-focused corporate strategy, primarily the ongoing clinical development of OvaPrime and the continued preclinical development of OvaTure.

我們的現金、現金等價物和短期投資餘額將用於支持我們以研發為重點的企業戰略，主要是 OvaPrime 的持續臨床開發和 OvaTure 的持續臨床前開發。

The cash outlays related to restructurings in the fourth quarter of 2017 were $0.9 million. We expect to incur additional cash outlays related to the restructurings of between $1 million and $1.5 million over 2018.

2017 年第四季度與重組相關的現金支出為 90 萬美元。我們預計 2018 年與重組相關的額外現金支出將在 100 萬至 150 萬美元之間。

Finally, we anticipate we will have sufficient funds without additional financing to support our operations into 2020, which will allow us to reach significant milestones for both OvaPrime and OvaTure.

最後，我們預計我們將有足夠的資金來支持我們到 2020 年的運營，而無需額外融資，這將使我們能夠實現 OvaPrime 和 OvaTure 的重要里程碑。

Thank you for your attention, I will now turn the call back over to Jennifer.

感謝您的關注，我現在將把電話轉回給詹妮弗。

Thank you, John. We will now begin the Q&A session. Operator?

謝謝你，約翰。我們現在將開始問答環節。操作員？

(Operator Instructions) And we have our first question from Alethia Young with Credit Suisse.

（操作員說明）我們有瑞士信貸的 Alethia Young 提出的第一個問題。

This is Eileen on for Alethia. Can you provide us with any additional color on the recent cell processing technique improvements in OvaPrime? And then, maybe, can you describe how this work informed your view on the ongoing Phase I trial expectations? And then secondly, in terms of the secondary endpoints for OvaPrime, what would you be most focused on from a clinical perspective? And would you call out any that were maybe stronger or weaker from the preliminary blinded dataset that you referenced before?

這是愛麗絲的艾琳。您能否為我們提供有關 OvaPrime 最近細胞處理技術改進的任何其他顏色？然後，也許，您能否描述一下這項工作如何影響您對正在進行的 I 期試驗預期的看法？其次，就 OvaPrime 的次要終點而言，從臨床角度來看，您最關注的是什麼？你會從你之前引用的初步盲法數據集中找出任何可能更強或更弱的東西嗎？

Sure, thanks, Eileen. This is Kris. So I guess I'll answer the last question first. With respect to the secondary endpoints in the OvaPrime study, so as you'll probably recall that the one blinded endpoint in all of that was really antral follicle count, because one ovary is injected and one ovary receives a sham injection. But beyond that, we're looking at hormone levels. And ultimately -- and primarily at IVF stimulations and ultimate embryo transfers. And so, in looking at all of that data, I don't -- the ultimate goal, obviously, is pregnancies in these patients. And I think what we can say without getting into too much detail is that we're not seeing strong signals on any of those secondary efficacy endpoints. That doesn't mean that there aren't subtle signals that will come out over time when we reach the end of the study, but we're not seeing strong signals that the therapy is producing an effect in these patients. So I think the other question was -- a couple of questions about cell processing and what we've done to improve that and then how does all of that then feed into our decision to move into the 1b/2a study. So on the sub-processing front, we really have made improvements across the, kind of, full spectrum of the process. So once we receive frozen biopsy tissue that involves a disaggregation steps, so essentially taking that issue and making it into a single cell suspension, then putting it through effects, cell sorting machines and then, ultimately, freezing those cells, transferring them back to the clinic where they're then thawed, washed and resuspended prior to injection into the patient. So we've really taken a very hard look at all of the steps, and the primary issue that we've addressed in all of the steps has to do with attrition of cells, so we're just losing -- we're losing a fair number of the cells at -- really at every step in that process. And I -- and we had identified over time ways that we could improve the process to dramatically improve the yield of cells that we can deliver back to the patient. So once we had come to that learning, it became clear that we would have a significant difference in dose and that it made sense then to move to a separate study and test that significantly higher dose in a new study. Then I think the combination of that improvement -- significant improvement in cell number and yield, combined with the fact that we're not seeing robust signals of efficacy, is what drove the decision to begin the new study. Before we do that, as we've said, we're engaging in a series of preclinical animal studies, which are really designed to evaluate the effect of that improvement in cell processing. So the increased yield and the increased cell purity that we're now able to deliver, we want to test that in animal models prior to completing the design of the new 1b/2a study.

當然，謝謝，艾琳。這是克里斯。所以我想我會先回答最後一個問題。關於 OvaPrime 研究中的次要終點，您可能還記得，所有這些研究中的一個盲法終點實際上是竇卵泡計數，因為註射了一個卵巢，而一個卵巢接受了假注射。但除此之外，我們正在研究激素水平。最終 - 主要是在 IVF 刺激和最終胚胎移植方面。因此，在查看所有這些數據時，我並沒有——最終目標顯然是這些患者的懷孕。而且我認為我們可以在不深入細節的情況下說的是，我們沒有在任何這些次要功效終點上看到強烈的信號。這並不意味著當我們到達研究結束時，隨著時間的推移不會出現微妙的信號，但我們沒有看到強烈的信號表明該療法正在對這些患者產生影響。所以我認為另一個問題是——關於細胞處理的幾個問題，以及我們為改進它所做的工作，然後所有這些如何影響我們進入 1b/2a 研究的決定。因此，在子處理方面，我們確實在整個流程的整個範圍內進行了改進。因此，一旦我們收到涉及分解步驟的冷凍活檢組織，那麼基本上就是解決這個問題並將其製成單細胞懸液，然後將其通過效應器、細胞分選機，然後最終冷凍這些細胞，將它們轉移回在註射到患者體內之前，將它們解凍、清洗並重新懸浮。所以我們真的非常認真地研究了所有步驟，我們在所有步驟中解決的主要問題與細胞的損耗有關，所以我們只是輸了——我們輸了相當多的細胞——實際上是在這個過程的每一步。而且我 - 我們已經確定了隨著時間的推移我們可以改進流程以顯著提高我們可以返回給患者的細胞產量的方法。因此，一旦我們了解了這一點，就很明顯我們會在劑量上有顯著差異，然後轉向一項單獨的研究並在一項新研究中測試顯著更高的劑量是有意義的。然後我認為這種改進的結合——細胞數量和產量的顯著提高，再加上我們沒有看到強有力的療效信號，是促使我們決定開始新研究的原因。在我們這樣做之前，正如我們所說的，我們正在進行一系列臨床前動物研究，這些研究的真正目的是評估這種改進對細胞處理的影響。因此，我們現在能夠提供更高的產量和更高的細胞純度，我們希望在完成新的 1b/2a 研究設計之前在動物模型中進行測試。

(Operator Instructions) And it seems that's all the time we have for questions today. I will now turn the call back over to Jennifer Viera for closing remarks.

（操作員說明）這似乎是我們今天所有的問題。我現在將把電話轉回 Jennifer Viera 以作結束語。

Thank you. And thanks, again, for joining us today. We look forward to providing additional updates on future calls. If you have any other questions, please feel free to reach out to us directly. Thanks, and have a good evening. Bye-bye.

謝謝。再次感謝您今天加入我們。我們期待在未來的通話中提供更多更新。如果您有任何其他問題，請隨時直接與我們聯繫。謝謝，晚上好。再見。

Thank you, ladies and gentlemen. This concludes today's conference. Thank you for participating. You may now disconnect.

謝謝你們，女士們，先生們。今天的會議到此結束。感謝您的參與。您現在可以斷開連接。