Rain Enhancement Technologies Holdco Inc (RAIN) 2023 Q2 法說會逐字稿

Good afternoon, ladies and gentlemen, and welcome to the Rain Oncology, Inc. Second Quarter 2023 Earnings Conference Call. (Operator Instructions) This call is being recorded on Thursday, August 10, 2023.

女士們、先生們，下午好，歡迎參加 Rain Oncology, Inc. 2023 年第二季度收益電話會議。 （操作員說明）此通話錄音時間為 2023 年 8 月 10 日星期四。

And I would now like to turn the conference call over to Mr. Dan Ferry of LifeSci Advisors. Please go ahead.

現在我想將電話會議轉交給 LifeSci Advisors 的 Dan Ferry 先生。請繼續。

Thank you, operator, and good afternoon, everyone. With me today on the phone is Avanish Vellanki, Chief Executive Officer of Rain Oncology; and Nelson Cabatuan, acting as VP of Finance. Following the call, Dr. Robert Doebele, Chief Scientific Officer and Chief Medical Officer, will be joining Avanish and Nelson for a short Q&A.

謝謝接線員，大家下午好。今天與我通電話的是 Rain Oncology 首席執行官 Avanish Vellanki； Nelson Cabatuan，擔任財務副總裁。電話會議結束後，首席科學官兼首席醫療官 Robert Doebele 博士將與 Avanish 和 Nelson 一起進行簡短的問答。

Earlier today, Rain issued a news release announcing the company's results for the second quarter of 2023. Copies of this news release and SEC filings can be found in the Investors section of our website. Full details on updates from the quarter can be found in our news release and 10-Q issued today.

今天早些時候，Rain 發布了一份新聞稿，宣布了公司 2023 年第二季度的業績。此新聞稿和 SEC 文件的副本可以在我們網站的投資者部分找到。有關本季度更新的完整詳細信息可以在我們今天發布的新聞稿和 10-Q 中找到。

Before we begin, I would like to remind you that statements made during this conference call that are not historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based upon Rain's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties as described in Rain's most recent quarterly reports on Form 10-Q and the annual report on Form 10-K filed with the Securities and Exchange Commission and other SEC filings. All forward-looking statements made during this conference call are based on management's assumptions and estimates as of today, August 10, 2023. Rain undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after today, except as required by law.

在我們開始之前，我想提醒您，本次電話會議期間所做的非歷史事實的陳述屬於 1995 年《私人證券訴訟改革法案》含義內的前瞻性陳述。這些前瞻性陳述基於 Rain 目前的情況。預期並涉及可能永遠不會實現或可能被證明是不正確的假設。由於 Rain 向美國證券交易委員會提交的最新 10-Q 表格季度報告和 10-K 表格年度報告中所述的各種風險和不確定性，實際結果可能與此類前瞻性陳述中的預期存在重大差異委員會和其他SEC 備案。本次電話會議期間做出的所有前瞻性陳述均基於管理層截至今天（2023 年8 月10 日）的假設和估計。Rain 沒有義務更新此類陳述以反映今天之後發生的事件或存在的情況，除非根據要求法律。

With that, I'd like to turn the call over to Avanish Vellanki, CEO of Rain Oncology. Avanish?

說到這裡，我想將電話轉給 Rain Oncology 首席執行官 Avanish Vellanki。阿尼什？

Thank you, Dan, and thanks to everyone for joining us for our second quarter 2023 earnings call. The second quarter was an important time at Rain Oncology as we provide the top line data readout on our Phase III global registrational trial for milademetan, our oral small molecule inhibitor of the MDM2-p53 complex in dedifferentiated liposarcoma, or DD LPS.

謝謝 Dan，也感謝大家參加我們的 2023 年第二季度財報電話會議。第二季度是Rain Oncology 的一個重要時刻，因為我們提供了Milademetan 的III 期全球註冊試驗的頂線數據讀數，這是我們的去分化脂肪肉瘤(DD LPS) 中MDM2-p53 複合物的口服小分子抑製劑。

We reported that the Phase III trial for milademetan did not meet its primary end point. We also announced that we would suspend the enrollment of our second clinical study, the MANTRA-2 study. We have begun the process of closing down MANTRA-2. Despite what we feel is very clear activity from the MANTRA-2 study, we do not feel its monotherapy activity rises to a level sufficient for registrational purposes, and closure of this study will ensure we remain judicious with our use of capital.

我們報告說，米拉美坦的 III 期試驗未達到其主要終點。我們還宣布將暫停第二項臨床研究 MANTRA-2 研究的招募。我們已經開始關閉 MANTRA-2 的過程。儘管我們認為 MANTRA-2 研究的活動非常明顯，但我們認為其單一療法活動並未上升到足以達到註冊目的的水平，這項研究的結束將確保我們在資本使用方面保持明智。

We hope to present final data from the MANTRA Phase III study and updated data from the MANTRA-2 Phase II study of milademetan in MDM2-amplified solid tumor patients in the fourth quarter of this year. We note the MANTRA-2 presentation will reflect a significant number of additional patients beyond what was presented last year. We continue to believe that reactivating p53 is an important therapeutic strategy to add to the armamentarium of anticancer therapies.

我們希望在今年第四季度提供米拉美坦治療 MDM2 擴增實體瘤患者的 MANTRA III 期研究的最終數據和 MANTRA-2 II 期研究的更新數據。我們注意到 MANTRA-2 的展示將反映出除去年展示的患者之外大量的額外患者。我們仍然相信，重新激活 p53 是抗癌療法的一個重要治療策略。

At Rain, we're proud that we were able to move as quickly as we did to test the hypothesis in a robust trial as we did for a global Phase III study, despite the results not being what we had hoped. Given these top line data for milademetan, we determined that Rain will be best positioned to achieve its business objectives by taking action to streamline operations, reprioritize its activities and implement certain cost-saving measures, including a reduction in force. We were able to implement those actions very quickly, resulting in substantial moderation of cash burn that will be apparent in the third quarter and beyond.

在 Rain，我們感到自豪的是，我們能夠像在全球 III 期研究中所做的那樣，在穩健的試驗中盡快檢驗假設，儘管結果並非我們所希望的。鑑於 milademetan 的這些主要數據，我們確定 Rain 將最有能力通過採取行動簡化運營、重新確定其活動的優先順序並實施某些節省成本的措施（包括減少人員）來實現其業務目標。我們能夠非常迅速地實施這些行動，從而導致現金消耗大幅減少，這一點將在第三季度及以後顯現出來。

Looking forward, we believe there are exciting opportunities ahead. It is no surprise that the challenging climate in biotech over the last few years has resulted in a number of interesting programs, companies and technologies being underfinanced and often without strong cross-departmental leadership.

展望未來，我們相信前方存在令人興奮的機遇。毫不奇怪，過去幾年生物技術領域充滿挑戰的環境導致許多有趣的項目、公司和技術資金不足，而且往往缺乏強有力的跨部門領導。

Our corporate development team has been rapidly reviewing an extraordinary number of actionable opportunities to license or acquire clinical-stage programs and technologies that may allow Rain to continue to try to make a difference for cancer patients.

我們的企業開發團隊一直在快速審查大量可行的機會來許可或獲取臨床階段的項目和技術，這些項目和技術可能使 Rain 能夠繼續努力為癌症患者帶來改變。

Although we won't comment on programs under diligence, there are a number of opportunities that could be a great fit for Rain with fascinating technology and novel therapeutic strategies for patients. We will update investors when appropriate on how we're going to push forward to add value for our shareholders.

儘管我們不會對正在盡職調查的項目發表評論，但有許多機會可能非常適合 Rain，因為它擁有令人著迷的技術和新穎的患者治療策略。我們將在適當的時候向投資者通報我們將如何推動為股東增加價值的最新情況。

Let me now hand it over to Nelson Cabatuan to discuss our financials. Nelson?

現在讓我將其交給 Nelson Cabatuan 來討論我們的財務狀況。納爾遜？

Thank you, Avanish. Before I proceed in providing updates for the financial results for the 3 months ended June 30, 2023, I would like to invite you to review our quarterly report and Form 10-Q filed today for more details.

謝謝你，阿瓦尼什。在我繼續提供截至 2023 年 6 月 30 日止 3 個月的財務業績更新之前，我想邀請您查看我們今天提交的季度報告和 10-Q 表格以了解更多詳細信息。

For the 3 months ended June 30, 2023, Rain reported a net loss of $22.1 million as compared to a net loss of $17.6 million for the same period in 2022. The increase was primarily related to clinical trial costs for our Phase III MANTRA trial and Phase II tumor-agnostic basket trial of MANTRA-2, as well as personnel costs.

截至 2023 年 6 月 30 日的三個月，Rain 報告淨虧損為 2210 萬美元，而 2022 年同期淨虧損為 1760 萬美元。這一增長主要與我們的 III 期 MANTRA 試驗的臨床試驗成本和MANTRA- 2 的II 期腫瘤不可知籃試驗，以及人員成本。

General and administrative expenses were $5.4 million for the 3 months ended June 30, '23 as compared to $3.5 million for the same period in 2022. The increase was primarily due to higher costs associated with launch preparation in anticipation of commercial launch of milademetan in liposarcoma, personnel, legal, outside consulting and accounting and audit fees.

截至2023 年6 月30 日止三個月的一般及行政費用為540 萬美元，而2022 年同期為350 萬美元。這一增長主要是由於預期米拉德美坦用於治療脂肪肉瘤的商業上市，與上市準備相關的成本較高、人事、法律、外部諮詢以及會計和審計費用。

In May 2023, we announced a reduction in our workforce in connection with the reprioritization of the company's clinical strategy designed to optimize company resources. We recorded restructuring charges of $2.8 million in the statements of operations for the 3 months ended June 30, 2023, comprised of $2.8 million cash severance, wellness and related employee benefits and taxes of affected employees, as well as $37,000 of stock-based compensation expense related to option modification.

2023 年 5 月，我們宣布裁員，以重新調整公司臨床戰略的優先順序，以優化公司資源。我們在截至2023 年6 月30 日的三個月運營報表中記錄了280 萬美元的重組費用，其中包括280 萬美元的現金遣散費、健康和相關員工福利以及受影響員工的稅收，以及37,000 美元的股票補償費用與選項修改有關。

Total noncash stock-based compensation expense were approximately $0.8 million for the 3 months ended June 30, 2023, as compared to $1.4 million for the same period in 2022.

截至 2023 年 6 月 30 日的三個月，非現金股票補償費用總額約為 80 萬美元，而 2022 年同期為 140 萬美元。

As of June 30, 2023, Rain had $86.3 million in cash, cash equivalents and short-term investments. Rain anticipates that its quarter-end cash position will provide runway into year-end 2026 in the absence of a corporate transaction and further financing.

截至2023年6月30日，Rain擁有8630萬美元的現金、現金等價物和短期投資。 Rain 預計，在沒有公司交易和進一步融資的情況下，其季度末現金狀況將為 2026 年底提供跑道。

As of June 30, 2023, Rain had approximately 36.4 million shares of common stock outstanding.

截至2023年6月30日，Rain擁有約3640萬股已發行普通股。

Let me now turn it back to Avanish.

現在讓我把話題轉回阿瓦尼什。

Thanks, Nelson. With that, we'll turn it over to the operator to take any questions.

謝謝，納爾遜。這樣，我們會將其轉交給操作員來回答任何問題。

(Operator Instructions) And your first question comes from Michael Schmidt from Guggenheim.

（操作員說明）您的第一個問題來自古根海姆的邁克爾·施密特。

It's Yige on for Michael. Maybe a quick one on the potential new opportunities you guys are reviewing. I know you can't talk much on it, but maybe on a high level, can you talk about what modality are you more interested at this moment?

由易格替補邁克爾。也許可以快速介紹一下你們正在審查的潛在新機會。我知道你不能就此談太多，但也許在較高的層面上，你能談談你目前對哪種模式更感興趣嗎？

Yige, thanks for the question. So at a very high level, we're trying to be opportunistic across a multitude of opportunities. I think we have certainly been approached with a variety of precision oncology strategies, but across the small molecule and large molecule approaches. So that's what we have certainly been reviewing so far. But I won't comment more broadly than that.

伊格，謝謝你的提問。因此，在很高的層面上，我們正在努力抓住眾多機會。我認為我們肯定已經採用了各種精準腫瘤學策略，但涵蓋小分子和大分子方法。這就是我們迄今為止一直在審查的內容。但我不會對此進行更廣泛的評論。

Your next question comes from Yigal from Citi.

您的下一個問題來自花旗銀行的 Yigal。

This is Ashiq Mubarack on for Yigal. I guess I wanted to ask about the future of milademetan at this point. Is it more or less on the shelf at this point for the foreseeable future? Or are there plans in the background that you're thinking about?

我是阿希克·穆巴拉克 (Ashiq Mubarack)，替補伊加爾 (Yigal)。我想此時我想問一下米拉德梅坦的未來。在可預見的未來，它現在或多或少都被擱置了？或者您正在考慮的背景計劃是什麼？

And then my second question was, I recall, in the past, you had a RAD52 asset in which you had in development. I'm just wondering if you have any thoughts on that asset and if maybe there's a world in which you reactivate that program?

然後我的第二個問題是，我記得過去，你們有一個 RAD52 資產正在開發中。我只是想知道您對該資產是否有任何想法，以及您是否可能在一個世界中重新激活該程序？

Ashiq, thanks, I think we can be brief here. So there are no plans at the current time for milademetan, and there's certainly no intention for deploying capital to support milademetan today. And same for the RAD52 program, we're not moving that forward, and we stopped all investment over a year ago.

Ashiq，謝謝，我想我們可以簡短地講一下。因此，目前沒有關於 milademetan 的計劃，並且今天當然沒有部署資金支持 milademetan 的意圖。對於 RAD52 計劃也是如此，我們不會繼續推進該計劃，並且我們在一年前就停止了所有投資。

Okay. Understood. Last question for me. I guess what's embedded in your cash runway guidance at this point? It doesn't sound like it includes any considerations for any potential deal you might do, so just curious what's in there right now.

好的。明白了。對我來說最後一個問題。我想您目前的現金跑道指南中包含了什麼內容？聽起來它並沒有包含對您可能進行的任何潛在交易的任何考慮，所以只是好奇現在裡面有什麼。

Sure. I'll start that, and then I'll ask Nelson to follow up with any additional detail. So in the cash flow guidance, we are certainly reflecting the closure of the existing studies that we had alluded to and maintenance of a lean organization that we think is sufficient for developing multiple earlier-stage clinical programs.

當然。我會開始，然後我會請納爾遜跟進任何其他細節。因此，在現金流量指導中，我們當然反映了我們提到的現有研究的結束以及我們認為足以開發多個早期臨床項目的精益組織的維護。

Nelson, do you have any additional comments?

尼爾森，您還有什麼其他意見嗎？

Yes. I just want to highlight that when we speak about cash runway through the end of 2026, it does not incorporate additional corporate consumption as well as additional financing. I just want to highlight that in the second half of this year 2023, we will see a significant reduction in cash runway.

是的。我只是想強調，當我們談論到 2026 年底的現金跑道時，它並不包括額外的企業消費和額外融資。我只是想強調，在 2023 年下半年，我們將看到現金跑道大幅減少。

And your next question comes from Joe Catanzaro from Piper Sandler.

您的下一個問題來自 Piper Sandler 的 Joe Catanzaro。

I just had one quick question actually on milademetan, though I appreciate that you won't be moving forward with that program at all. I'm wondering if since you've had more time to digest the MANTRA trial, whether you've been able to sort of hone in on any potential reasons as to why milademetan underperformed the previous data you have generated in DD LPS?

我只是有一個關於 milademetan 的簡單問題，儘管我很高興您根本不會繼續該計劃。我想知道既然您有更多的時間來消化 MANTRA 試驗，您是否能夠磨練出任何潛在的原因來解釋為什麼 milademetan 的表現不如您之前在 DD LPS 中生成的數據？

Joe, thanks for the question. This is Bob Doebele. So I think for that question, we'll refer you to our upcoming planned presentations in the fourth quarter on a medical conference.

喬，謝謝你的提問。這是鮑勃·多貝爾。因此，我認為對於這個問題，我們將向您推薦我們即將在第四季度舉行的醫學會議上的演講。

And your next question comes from Sam Slutsky from LifeSci Capital.

您的下一個問題來自 LifeSci Capital 的 Sam Slutsky。

This is Anshul on for Sam. One question I had, basically, as you're looking into these licensing and bringing other assets, is there sort of a sweet spot of deals you're looking for in terms of stage of development or deal structure and so forth?

這是安舒爾為山姆代言的。我有一個問題，基本上，當您正在研究這些許可並帶來其他資產時，您在開發階段或交易結構等方面是否正在尋找一種最佳交易點？

So first of all, Anshul, I think what we could comment there is we want to be able to leverage our clinical organization. And again, I think the expertise that the team demonstrated through the MANTRA and MANTRA-2 studies, we think, is exemplary. And so clinical stage is an important attribute of where we're looking. And I'll leave the comments there.

首先，安舒爾，我認為我們可以評論的是，我們希望能夠利用我們的臨床組織。再說一次，我認為該團隊通過 MANTRA 和 MANTRA-2 研究展示的專業知識堪稱典範。因此，臨床分期是我們正在尋找的一個重要屬性。我會將評論留在那裡。

And your next question comes from Graig Suvannaevjh from Mizuho Securities.

您的下一個問題來自瑞穗證券 (Mizuho Securities) 的 Graig Suvannaevjh。

Just a question for me. How do you weigh the pluses and minuses between starting essentially almost like a new type of Rain Oncology with a new asset versus other corporate options like a potential reverse merger or with some public or private company?

只是問我一個問題。您如何權衡從本質上幾乎像新型 Rain Oncology 那樣擁有新資產與其他公司選擇（例如潛在的反向合併或與某些上市或私營公司合作）之間的優缺點？

Avantika, thanks for the question. It's a great question. So I said the way that we approach that is we take a look at the attractiveness of the options that were presented, the options that we find and the actionability of those opportunities. And if we can find an avenue that we think we can add value to, that truly becomes more attractive than one of the other alternatives. So we are certainly looking at all of those avenues and in the absence of an investable option with our existing cash resources and even our personnel and other options become available. But at the current time, I think with my comments on the call, this is a unique time in biotech where there's a multiple of opportunities that are available to companies in our current position.

阿凡提卡，謝謝你的提問。這是一個很好的問題。所以我說，我們採取的方法是，我們審視所提出的選項的吸引力、我們發現的選項以及這些機會的可操作性。如果我們能夠找到一條我們認為可以增加價值的途徑，那麼它確實比其他選擇更具吸引力。因此，我們當然正在考慮所有這些途徑，並且在缺乏可投資選擇的情況下，我們現有的現金資源甚至我們的人員和其他選擇都是可用的。但目前，我認為，根據我對這次電話會議的評論，這是生物技術領域的一個獨特時期，我們目前所處位置的公司可以獲得多種機會。

(Operator Instructions) And your next question comes from Mitchell Kapoor from HCW.

（操作員說明）您的下一個問題來自 HCW 的 Mitchell Kapoor。

First, I just wanted to ask just broadly the options on the table. Obviously, you mentioned a new precision oncology therapy, a new technology platform. I wanted to learn a little bit more about what you're thinking about the technology platform, what could that look like, what broadly does that mean. And then how many assets might you in-license? Is there kind of a limit there? And then is there a hope for how long this could take?

首先，我只是想大致詢問一下擺在桌面上的選項。顯然，您提到了一種新的精準腫瘤治療，一種新技術平台。我想更多地了解您對技術平台的看法，它會是什麼樣子，它的廣泛含義是什麼。那麼您可能會許可多少資產？那裡有某種限制嗎？那麼這可能需要多長時間？

All great questions, Mitchell. Thanks for the question. We are not going to respond in any meaningful depth to any of those questions. We want to leave it sufficiently broad at this point until they reach a point where it warrants further articulation to the public. And we'll provide those commentaries when we can, but now it's not the appropriate time to provide that color.

所有的問題都很好，米切爾。謝謝你的提問。我們不會對這些問題做出任何有意義的深度回應。我們希望在這一點上讓它足夠廣泛，直到他們達到需要向公眾進一步闡明的程度。我們將盡可能提供這些評論，但現在不是提供這種顏色的適當時間。

Okay. Understood. And maybe this is a question for Nelson. I just wanted to ask a finance question. So as expenses have changed to kind of moderate the cash burn, what broadly could we see for the next few quarters in terms of SG&A and R&D in the absence of any kind of transaction?

好的。明白了。也許這是納爾遜的問題。我只是想問一個財務問題。因此，隨著支出發生變化以緩解現金消耗，在沒有任何交易的情況下，未來幾個季度的銷售、行政管理和研發方面我們會看到什麼？

Thanks, Mitchell. So in terms of the cash burn expense in Q3 onwards, it's going to be significantly lower compared to what you've seen in the first 2 quarters of this year and the prior year. I don't want to go through the details of this, but we'd expect a runway that's really low compared to the runway, in the $20 million, in the first 2 quarters of this year.

謝謝，米切爾。因此，就第三季度以後的現金消耗費用而言，與今年前兩個季度和去年的情況相比，它將顯著降低。我不想詳細說明這一點，但我們預計今年前 2 季度的跑道費用將低於 2000 萬美元。

And there are no further questions at this time. Avanish, you may continue your conference.

目前沒有其他問題。消失，您可以繼續會議了。

Thank you, operator. We look forward to keeping everyone abreast of our plans once a forward plan has been certified. Thank you.

謝謝你，接線員。一旦遠期計劃獲得認證，我們期待讓每個人都了解我們的計劃。謝謝。

Ladies and gentlemen, this concludes your conference call for today. We thank you very much for participating and ask that you please disconnect your lines. Have a great day.

女士們、先生們，今天的電話會議到此結束。我們非常感謝您的參與，並請您斷開線路。祝你有美好的一天。