Chimerix Inc (CMRX) 2024 Q3 法說會逐字稿

Good morning, ladies and gentlemen and welcome to the Chimerix third quarter, 2024 earnings conference call. I would now like to introduce you to your host for today's call. Will O'Connor from Stern Investor Relations. Please proceed.

女士們、先生們，早安，歡迎參加 Chimerix 2024 年第三季財報電話會議。現在我想向您介紹今天電話會議的主持人。史特恩投資者關係公司的威爾·奧康納 (Will O’Connor) 說。請繼續。

Thank you, operator. Good morning, everyone. And welcome to the Chimeric third quarter, 2024 financial and operating results conference call. This morning, we issued a press release related to our third quarter operating update. You can access the press release in our investors section of the website. With me on today's call are President and Chief executive of Officer Mike Andriole, Chief Scientific Officer Josh Allen, Chief Financial Officer Michelle LaSpaluto, Chief Medical Officer Allen Melemed and Chief operating and Commercial Officer Tom Riga.

謝謝您，接線生。大家早安。歡迎參加 Chimeric 2024 年第三季財務與營運業績電話會議。今天早上，我們發布了一份與第三季營運更新相關的新聞稿。您可以在我們網站的投資者部分訪問該新聞稿。參加今天電話會議的還有總裁兼執行長 Mike Andriole、首席科學官 Josh Allen、財務長 Michelle LaSpaluto、首席醫療官 Allen Melemed 以及首席營運兼商務長 Tom Riga。

For questions before we begin. I'd like to remind you that the statements made on today's call include forward statements within the meaning of the private securities Litigation Reform Act of 1,995 and are subject to risks and uncertainties and other factors. These risks and uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. Please refer to our filings with the SEC for a more complete disclosure of these risks and uncertainties at this time, I'll now turn the call over to President and Chief Executive Officer, Mike Andriole.

在我們開始之前回答問題。我想提醒您，今天電話會議上所作的聲明包括 1995 年私人證券訴訟改革法案所定義的前瞻性聲明，並且受風險、不確定性和其他因素的影響。這些風險和不確定性以及其他因素可能導致實際結果與前瞻性陳述中提及的結果有重大差異。請參閱我們向美國證券交易委員會提交的文件，以獲得有關目前這些風險和不確定性的更完整披露，現在我將把電話轉給總裁兼首席執行官邁克·安德里奧爾 (Mike Andriole)。

Thank you will. Good morning, everyone and thanks for joining us. The third quarter was marked by continued execution across our pipeline including continued enrollment in our global phase three action study of do dordaviprone.

謝謝你會的。大家早安，感謝大家的加入。第三季的特點是我們整個產品線的持續執行，包括繼續參與 do dordaviprone 的全球第三階段行動研究。

And we are nearing complete enrollment of our phase one dose escalation studies for our second generation dordaviprone ONC206.

我們第二代 dordaviprone ONC206 第一階段劑量遞增研究的招募工作即將完成。

The phase three action study is active in 15 countries worldwide and our first interim data readout is potentially less than a year away. During this past quarter, we received confirmation from the pre specified interim safety review undertaken by the study's independent Data Monitoring Committee which recommended the action study continue as is with no change to study conduct.

第三階段行動研究目前在全球 15 個國家開展，我們的第一份中期數據讀數可能會在不到一年的時間內公佈。在過去的一個季度中，我們收到了由該研究的獨立資料監測委員會進行的預先指定的中期安全審查的確認，該審查建議行動研究繼續進行，不改變研究行為。

This is always welcome news but even more. So, in the case of the action study where we have two treatment arms one at the phase 2, 625mg dose administered once per week and a second treatment arm administering 625mg twice per week on consecutive days or essentially a double dose of the phase two schedule.

這始終是個令人欣喜的消息，但更令人欣喜的是。因此，在行動研究中，我們有兩個治療組，一個處於第 2 階段，每週給藥一次 625 毫克劑量，第二個治療組連續幾天每週給藥兩次 625 毫克，或基本上是第 2 階段計劃的雙倍劑量。

Passing this IDMC safety review with no change to study conduct to any arm is a meaningful milestone and underscores the well documented safety profile of dordaviprone that makes it both a promising profile as a potential monotherapy but also an ideal candidate as a potential backbone therapy.

透過此 IDMC 安全審查且任何組的研究實施均未發生改變，這是一個意義重大的里程碑，凸顯了 dordaviprone 有據可查的安全性，這使其不僅成為一種有前途的潛在單一療法，也是一種潛在的骨幹療法的理想候選者。

Last month, we participated in the European Association for Neuro-Oncology annual meeting in Glasgow Scotland. It was evident that the enthusiasm across the European community for this program and the degree of support from so many investigators who recognize the very high unmet need in this patient population only continues to strengthen with time turning a little closer to home.

上個月，我們參加了在蘇格蘭格拉斯哥舉行的歐洲神經腫瘤學會年會。顯然，隨著時間的推移，整個歐洲社會對該計劃的熱情以及眾多研究人員對該計劃的支持程度只會繼續增強，因為他們認識到該患者群體中存在非常高的未滿足需求。

The annual meeting for the Society for Neuro-Oncology also known as snow will occur in Houston, Texas later this month where we're planning a large presence. We view our partnership with the snow organizers and engagement at this pivotal conference as important to the success of our programs. Not only will we have presentations for dordaviprone, but we'll also showcase ONC206 abstracts for that conference will release next week. So, please stay tuned for more details for those attending. We're looking forward to seeing many of you and our investigators in person.

神經腫瘤學會年會（又稱雪會議）將於本月晚些時候在德克薩斯州休斯頓舉行，我們計劃派出大量人員出席。我們認為與滑雪組織者的合作以及在這次關鍵會議的參與對於我們計畫的成功至關重要。我們不僅會有關於 dordaviprone 的演示，還將展示將於下週發布的該會議的 ONC206 摘要。因此，請繼續關注與會人員的更多詳細資訊。我們期待著親自見到你們和我們的調查員。

We continue to make progress with the Therapeutic goods administration or TGA to file for provisional approval in Australia. Well, this was not on our radar last year. We were agile when an opportunity arose earlier this year and we're now in a position to file an NDA for provisional approval around your end. Having the NDA document ready for submission in Australia also aids our capacity and timelines. Should we have a positive interim overall survival outcome for action next year.

我們繼續與澳洲治療用品管理局（TGA）合作，申請臨時批准。嗯，去年我們還沒考慮到這一點。今年早些時候，當機會出現時，我們迅速做出了反應，現在我們可以提交保密協議 (NDA) 以獲得您方面的臨時批准。準備好在澳洲提交的保密協議文件也有助於提高我們的能力和時間表。我們明年採取行動時是否應該得到積極的中期整體生存結果。

To that end, we are judiciously preparing the company in the market for dordaviprone potential commercialization as we may be within a year. From the first interim readout with our phase three action study and our expanded access programs in the US and Europe, we now have a well laid foundation with hospitals and physicians who have ongoing treatment experience with dordaviprone, recall there are no approved therapies specific to this patient population and we consequently expect a rapid uptake upon potential commercialization, forecasting a potential global market opportunity over $750 million.

為此，我們正在審慎地為公司在一年內實現 dordaviprone 的潛在商業化做好準備。從我們第三階段行動研究的第一次中期讀數和我們在美國和歐洲的擴展獲取計劃開始，現在我們與擁有使用 dordaviprone 進行持續治療經驗的醫院和醫生建立了良好的基礎，請記住，目前尚無針對該患者群體的批准療法，因此，我們預計潛在商業化後將迅速預計潛在的全球市場機會超過 7.5 億美元。

Turning to our second generation of imipridone ONC206, our objective for the year is to gather safety and PK data in an unselected CNS patient population and to evaluate lead indications for the program. I'm happy to report the phase one dose escalation is nearing completion and the lab has been working diligently on nonclinical studies to inform the next step for the program we continue to see ONC206 is well tolerated in adult and pediatric patients. As we near completion of the dose escalation studies. As we review the incoming clinical and preclinical data, we plan to announce next steps for the program in the coming months.

談到我們的第二代咪唑啉 ONC206，我們今年的目標是在未選擇的 CNS 患者群體中收集安全性和 PK 數據，並評估該計劃的主要適應症。我很高興地報告，第一階段的劑量遞增即將完成，實驗室一直在努力進行非臨床研究，為該計劃的下一步提供信息，我們繼續看到 ONC206 在成人和兒科患者中耐受性良好。我們即將完成劑量遞增研究。在我們審查即將收到的臨床和臨床前數據時，我們計劃在未來幾個月內宣布該計劃的下一步。

Before I turn the call over to Michelle for a review of the financials. I'd like to take a brief moment to recognize the recent promotion of Josh Allen as our Chief Scientific Officer since joining Chimerix in 2021 with the acquisition of Oncoceutics. Josh has been an integral team leader and a trusted colleague to many across the company and has continually advanced the research and development of the Aipri class of compounds from academic discovery to the lead registration phase program. Please join me in congratulating Josh on this well-deserved promotion with that. I'll turn the call over to Michelle for a brief review of our financials.

在我將電話轉給米歇爾以便她審查財務狀況之前。我想花一點時間來慶祝喬希艾倫 (Josh Allen) 自 2021 年收購 Oncoceutics 並加入 Chimerix 以來晉升為我們的首席科學官。Josh 是公司中不可或缺的團隊領導者和值得信賴的同事，他不斷推動 Aipri 類化合物的研究和開發，從學術發現到先導註冊階段計劃。請和我一起祝賀喬希當之無愧的晉升。我會把電話轉給米歇爾，讓她簡單回顧一下我們的財務狀況。

Thank you, Mike. Earlier today we issued a press release containing our financial results for the third quarter of 2024 for the third quarter of 2024. We reported a net loss of $22.9 million compared to a net loss of $24 million in the third quarter of 2023. Research and development expenses increased to $19.6 million for the third quarter of 2024 compared to $17.4 million for the same period of 2023. This was primarily driven by increased spending in the action study.

謝謝你，麥克。今天早些時候，我們發布了一份新聞稿，其中包含我們 2024 年第三季的財務表現。我們報告的淨虧損為 2,290 萬美元，而 2023 年第三季的淨虧損為 2,400 萬美元。2024 年第三季的研發費用從 2023 年同期的 1,740 萬美元增加至 1,960 萬美元。這主要是由於行動研究支出的增加。

General and administrative expenses decreased to $5.2 million for the third quarter of 2024 compared to $9.3 million for the same period in 2023. This decrease is due to a one-time non-cash expense related to historical grants recognized during the same period in 2023.

2024 年第三季的一般及行政費用從 2023 年同期的 930 萬美元減少至 520 萬美元。這一下降是由於 2023 年同期確認的歷史補助相關的一次性非現金支出。

We ended the third quarter with just over $152 million in cash and cash equivalent as anticipated. Our cash burn rate did experience a modest increase this quarter as in preparation for the commercialization of dordaviprone we are committed to sensible cash management. Currently, we have a cash runway extending into the fourth quarter of 2026.

正如預期，我們在第三季結束時的現金和現金等價物略高於 1.52 億美元。本季我們的現金消耗率確實略有增加，因為為了準備 dordaviprone 的商業化，我們致力於合理的現金管理。目前，我們的現金流量可延伸至 2026 年第四季。

With that, I will turn the call back over to Mike for closing remarks.

說完這些，我將把電話轉回給麥克，請他作最後發言。

Thanks Michelle. We've continued to execute our plan as expected in the third quarter with a focus on bringing dordaviprone to patients as soon as possible. We're beginning to prepare our organization to launch dordaviprone and are excited about the promise to further broaden our pipeline in the future by advancing ONC206 or through business development initiatives with that, Leonardo. We'll open the call to questions.

謝謝米歇爾。我們在第三季繼續按預期執行計劃，重點是盡快將 dordaviprone 帶給患者。我們開始準備推出 dordaviprone，並對未來透過推進 ONC206 或透過與 Leonardo 的業務發展計劃進一步拓寬我們產品線的承諾感到興奮。我們將開始回答問題。

Thank you. (Operator Instructions)

謝謝。（操作員指令）

Maury Raycroft. Please go ahead.

莫里·雷克羅夫特。請繼續。

Can you talk about how you're preparing the submission of the NDA for Australia and a potential launch by the end of 25. Are how are you using these commercialization efforts to potentially scale the organization for a potential US launch too? Do you plan to leverage that NBA submission to dovetail into conversations with other regulatory agencies for accelerated approval path as well?

您能否談談您如何準備向澳洲提交保密協議併計劃在 25 月底前推出該產品？您如何利用這些商業化努力來擴大組織規模並在美國推出產品？您是否計劃利用 NBA 的提交來與其他監管機構進行對話，以加快審批路徑？

Yeah, thanks for the question. So, you know, there's probably two parts to that question, there's a regulatory component and the commercial component. So, I'll ask Tom Riga to comment on the commercial side, on the regulatory side, you know, having the backbone of the new drug application complete for Australia has great utility in other markets around the world. There's a lot of overlap between that backbone and what might be needed or expected in other markets around the world. So, we see synergy there and having this ready.

是的，謝謝你的提問。所以，你知道，這個問題可能分為兩個部分，即監管部分和商業部分。因此，我會請湯姆·裡加 (Tom Riga) 對商業方面和監管方面進行評論，您知道，在澳洲完成新藥申請的主幹對世界其他市場具有巨大的實用性。該主幹與世界其他市場可能需要或期望的內容有許多重疊。所以，我們看到了那裡的協同作用並且已經做好準備。

Of course, the efficacy component for this application will be predicated on the phase two response rate data that we've previously announced in terms of where we might utilize that in other markets around the world. We continue to look at the action study as the first opportunity for registration and other markets around the world. But should that change, we'll update the market accordingly, Tom, do you want to comment on our commercial? Yeah.

當然，該應用的功效部分將基於我們先前公佈的第二階段回應率數據，具體細節我們可能會在世界其他市場使用這些數據。我們繼續將行動研究視為註冊和全球其他市場的首次機會。但如果情況發生變化，我們將相應地更新市場，湯姆，你想對我們的廣告發表評論嗎？是的。

We are enthusiastic to be inside of a year of first potential data from the action study. And I think as we approach the market. Our, me affairs team is up and running and in full force. And the early commercialization efforts are focused around payer engagement, forecast confirmation, some of the commercial build and internal infrastructure. But we're taking a very gated spend. I think you could see in our SG&A line, we are going to be conservative and gated as we get more data within the program. But we'll make sure that we're ready for the market as we're enthusiastic about the opportunity.

我們很高興能在一年之內獲得該行動研究的首批潛在數據。我認為，隨著我們逐漸接近市場。我們的事務團隊已全面運作。早期的商業化努力主要集中在付款人參與、預測確認、部分商業建設和內部基礎設施。但我們的支出是有嚴格限制的。我想您可以從我們的銷售、一般及行政開支項目中看到，隨著我們在計劃內獲得更多數據，我們將採取保守和限制的態度。但我們一定會做好進入市場的準備，因為我們對這個機會充滿熱情。

Great. Thanks for the clarity. And just another quick follow up. So, EVS announced the execution of contract options for $67.4 million to acquire Tembexa for a national stop national preparedness efforts. And they also announced yesterday that they'll conduct clinical trials of Tembexa for a monkeypox in Africa. So how much of that total contract value would chimeric be eligible to receive? And what would be the timing for receiving that milestone? Do you have any insight into how the monkeypox outbreak has affected the U.S. government's initiative to stockpile Tembexa for smallpox?

偉大的。謝謝你的澄清。接下來還有另一個快速跟進。因此，EVS 宣布執行價值 6,740 萬美元的合約選擇權，以收購 Tembexa，以在全國範圍內開展國家級防備工作。他們昨天也宣布將在非洲進行 Tembexa 治療猴痘的臨床試驗。那麼 Chimeric 有資格獲得該合約總價值的多少呢？那麼實現這里程碑的時間是什麼時候？您是否了解猴痘疫情對美國政府儲存天花藥物 Tembexa 的措施有何影響？

Thanks for the question. Let me take the monkeypox part of that question and then, I'll ask Michelle to answer. You know, the first part on, the partial clean exercise of 67 million from a monkeypox perspective, yes, emergent did announce participation in a randomized monkeypox study at the end of business yesterday their best positioned to answer questions on that. That is an ongoing new study to explore Tembexa utility in that population. We'll see how, that unfolds in the coming years that could lead to potential royalties to Chimerix when and if there could be international sales associated with that indication. But of course, they're at the very beginning of that process. Now, Michelle comments on, the milestone.

謝謝你的提問。讓我先回答有關猴痘的部分，然後我會請米歇爾來回答。您知道，第一部分，從猴痘的角度來看 6700 萬美元的部分清潔運動，是的，Emergent 確實在昨天下班時宣布參與一項隨機猴痘研究，他們最有能力回答有關這個問題。這是一項正在進行的新研究，旨在探索 Tembexa 在該族群中的效用。我們將拭目以待，未來幾年情況將如何發展，如果該適應症可以進行國際銷售，那麼 Chimerix 可能會獲得特許權使用費。但當然，他們才處於這個過程的開始階段。現在，米歇爾評論了這個里程碑。

Yes. Barta did exercise a partial exercise with emergent for Tembexa, which was just over $67 million. And with that option, we are due approximately $2.7 million related to that exercise. However, due to accounting rules, we have to wait until the cash is received for that to be recorded. So, hopefully next quarter, we'll have a little bit more information on that.

是的。Barta 確實與 Emergent 公司合作對 Tembexa 進行了部分融資，融資金額略高於 6,700 萬美元。透過此選項，我們將獲得與該活動相關的約 270 萬美元。但是，根據會計規則，我們必須等到收到現金才能記錄。因此，希望下個季度我們能獲得更多有關此方面的資訊。

Yeah. that exercise I think goes out to 2027 Michelle. So, it's a multi year exercise of, of a plan that's about or an option. That's I think just over half of the value of, of that next option.

是的。我認為這項演習將持續到 2027 年，米歇爾。所以，這是一項多年的計劃，或者說是一個選擇。我認為這僅佔下一個選項價值的一半多一點。

That is correct as that's our understanding.

這是正確的，因為這是我們的理解。

Great. Thank you so much for taking my questions.

偉大的。非常感謝您回答我的問題。

Thank you. (Operator Instructions)

謝謝。（操作員指令）

Thanks, Leonardo. Thank you everyone for your time this morning and we look forward to updating you in the coming months.

謝謝，萊昂納多。感謝大家今天早上抽出時間，我們期待在接下來的幾個月為大家提供最新消息。

Ladies and gentlemen, that includes today's call. Thank you all for joining you. (Operator Instructions)

女士們、先生們，其中包括今天的電話會議。感謝大家的加入。 （操作員指令）