Altimmune Inc (ALT) 2024 Q3 法說會逐字稿

Good day, ladies and gentlemen, and welcome to Altimmune, Inc.'s third quarter 2024 financial results conference call. (Operator Instructions) As a reminder, this call is being recorded.

女士們、先生們，美好的一天，歡迎參加 Altimmune, Inc. 的 2024 年第三季財務業績電話會議。（操作員說明）謹此提醒，此通話正在錄音。

I would now like to introduce your host for today's conference call, Lee Roth of Burns McClellan, Investor Relations Adviser to Altimmune. Lee, you may begin.

現在我想介紹一下今天電話會議的主持人，Burns McClellan 的 Lee Roth，Altimmune 的投資者關係顧問。李，你可以開始了。

Thanks, operator. Good morning, everyone. And once again, thank you for participating in Altimmune's third quarter 2024 financial results and business update conference call. On today's call, you'll hear from Dr. Vipin Garg, our Chief Executive Officer; Dr. Scott Harris, our Chief Medical Officer; and Andrew Shutterly, our acting Chief Financial Officer. Dr. Scot Roberts, our Chief Scientific Officer; and Greg Weaver, our newly appointed Chief Financial Officer are on the line as well, and will join us for the Q&A session.

謝謝，接線生。大家早安。再次感謝您參加 Altimmune 2024 年第三季財務業績和業務更新電話會議。在今天的電話會議上，您將聽到我們的執行長 Vipin Garg 博士的演講； Scott Harris 博士，我們的首席醫療官；以及我們的代理財務長安德魯舒特利 (Andrew Shutterly)。Scott Roberts 博士，我們的首席科學官；我們新任命的財務長 Greg Weaver 也在線上，並將與我們一起參加問答環節。

A press release covering our third quarter 2024 financial results and corporate update was issued earlier this morning and can be found on the Investor Relations section of the company's website.

今天早上早些時候發布了涵蓋我們 2024 年第三季財務業績和公司更新的新聞稿，可以在公司網站的投資者關係部分找到。

Before we begin, I'd like to remind everyone that remarks about future expectations, plans, and prospects constitute forward-looking statements for purposes of the safe harbor provision under the Private Securities Litigation Reform Act of 1995. Altimmune cautions that these forward-looking statements are subject to risks and uncertainties that could cause our actual results to differ materially from those indicated. For a full review of the risk factors that could affect the company's future results and operations, we refer you to our filings with the SEC.

在開始之前，我想提醒大家，有關未來預期、計劃和前景的言論構成前瞻性陳述，以符合 1995 年《私人證券訴訟改革法案》中的安全港條款。Altimmune 警告說，這些前瞻性陳述存在風險和不確定性，可能導致我們的實際結果與所示結果有重大差異。為了全面審查可能影響公司未來業績和營運的風險因素，我們建議您參閱我們向 SEC 提交的文件。

I'll also direct you to read the forward-looking statements disclaimer in our press release issued this morning, which is now available on our website. Any statements made on this call speak only as of today's date, November 12, 2024, and the company does not undertake any obligation to update any of these forward-looking statements to reflect events or circumstances that occur on or after today. As a reminder, this call is being recorded, and will be available for audio replay on the Altimmune website.

我還將指導您閱讀今天上午發布的新聞稿中的前瞻性聲明免責聲明，該聲明現已在我們的網站上提供。本次電話會議中所做的任何聲明僅代表截至今天（2024 年 11 月 12 日）的情況，本公司不承擔更新任何這些前瞻性聲明以反映今天或之後發生的事件或情況的義務。提醒一下，此通話正在錄音，並將在 Altimmune 網站上進行音訊重播。

With that, it's my pleasure to turn the call over to Dr. Vipin Garg, Chief Executive Officer of Altimmune. Vipin?

至此，我很高興將電話轉給 Altimmune 執行長 Vipin Garg 博士。維賓？

Thank you, Lee. Good morning, everyone, and thank you for joining us for our third quarter corporate update. In the three months since our last conference call, we have achieved several important milestones. These recent accomplishments, coupled with other upcoming catalysts, give us a high degree of confidence that we are in position for 2025 to be a transformational year for Altimmune.

謝謝你，李。大家早安，感謝您參加我們的第三季公司更新。自上次電話會議以來的三個月裡，我們實現了幾個重要的里程碑。這些最近的成就，加上其他即將到來的催化劑，讓我們充滿信心，相信 2025 年將成為 Altimmune 轉型的一年。

First, our Phase 2b IMPACT trial of pemvidutide in MASH is now fully enrolled, and top-line efficacy data is expected in Q2 2025. With a successful readout from IMPACT, pemvidutide would be the first MASH therapy to achieve both fibrosis improvement and significant weight loss at 24 weeks of treatment. Following this readout, we expect to hold an end-of-Phase 2 meeting for MASH with FDA in Q4 2025.

首先，我們的 Pemvidutide 在 MASH 的 2b 期 IMPACT 試驗現已全部入組，預計將於 2025 年第二季獲得一線療效數據。隨著 IMPACT 的成功讀取，pemvidutide 將成為第一個在治療 24 週時實現纖維化改善和體重顯著減輕的 MASH 療法。在此消息發布後，我們預計將於 2025 年第四季與 FDA 舉行 MASH 第 2 階段結束會議。

For our obesity program, as announced last week, we achieved alignment with the FDA at our recent end-of-Phase 2 meeting on a comprehensive Phase 3 registrational program designed to leverage the key attributes of pemvidutide. The important strategic takeaway here is that we now have a differentiated Phase 3 ready asset that we believe has the potential to benefit obese and overweight patients, and fill gaps in the treatment of the comorbidities of obesity left by existing treatments currently on the market. To realize the full potential of pemvidutide, we have made the strategic decision to expand our R&D investments into development of up to three additional indications that leverage the enhanced glucagon activity and other attributes of pemvidutide.

對於我們的肥胖計劃，正如上周宣布的那樣，我們在最近的第 2 階段結束會議上與 FDA 就一項旨在利用 pemvidutide 關鍵屬性的綜合第 3 階段註冊計劃達成了一致。這裡重要的策略要點是，我們現在擁有差異化的第三階段資產，我們相信它有可能使肥胖和超重患者受益，並填補目前市場上現有治療方法在治療肥胖合併症方面的空白。為了充分發揮pemvidutide的潛力，我們做出了策略決策，將我們的研發投資擴大到開發多達三個額外的適應症，以利用pemvidutide增強的胰高血糖素活性和其他屬性。

We plan to submit an IND for the first of these indications by the end of 2024, and preparations are underway for the initiation of that Phase 2 clinical trial in H1 2025 -- in the first half of 2025. We believe each of these indications represents a substantial commercial opportunity that will create value for our shareholders. Importantly, these indications were chosen as we believe we can develop these indications ourselves, and we expect to provide more details in the coming months.

我們計劃在 2024 年底之前提交第一個適應症的 IND，目前正在準備在 2025 年上半年（即 2025 年上半年）啟動該 2 期臨床試驗。我們相信，這些跡像中的每一個都代表著巨大的商業機會，將為我們的股東創造價值。重要的是，選擇這些適應症是因為我們相信我們可以自己發展這些適應症，我們預計在未來幾個月內提供更多詳細資訊。

To summarize, our overarching development strategy continues to focus on securing a partnership centered around obesity, while moving full speed ahead to advance pemvidutide in MASH and launch development efforts in these additional indications. Upon a positive data readout from Phase 2b IMPACT trial in the second quarter of 2025, we expect to be ready to start a Phase 3 program in MASH by the end of next year. We continue to believe that pemvidutide is a highly differentiated agent from others and in strategically important ways, relative to the current metabolic disease landscape.

總而言之，我們的整體開發策略繼續專注於確保以肥胖為中心的合作夥伴關係，同時全速前進以推進 MASH 中的pemvidutide 並啟動針對這些其他適應症的開發工作。在 2025 年第二季 2b 期 IMPACT 試驗獲得積極數據後，我們預計將在明年年底前準備好啟動 MASH 的 3 期計畫。我們仍然相信，相對於當前的代謝疾病格局，培維肽是一種與其他藥物高度差異化的藥物，並且在策略上具有重要意義。

With that, I'll now turn the call over to our Chief Medical Officer, Dr. Scott Harris, to discuss our clinical plans in more details. Scott?

現在，我將把電話轉給我們的首席醫療官 Scott Harris 博士，以更詳細地討論我們的臨床計劃。史考特？

Thank you, Vipin. As noted, we completed enrollment in the Phase 2b IMPACT trial of pemvidutide in MASH in late September, and are on track to report top-line efficacy data in the second quarter of next year. Recall, the trial is evaluating approximately 190 subjects with and without diabetes, randomized 1:2:2 to receive either 1.2 milligrams, 1.8 milligrams pemvidutide or placebo for 48 weeks. The key efficacy endpoints are MASH resolution or fibrosis improvement at 24 weeks of treatment with subjects followed for an additional 24 weeks to a total of 48 weeks for safety and biomarker responses.

謝謝你，維平。如前所述，我們在 9 月下旬完成了 MASH 中 pemvidutide 2b 期 IMPACT 試驗的入組，並預計在明年第二季報告頂線療效數據。回想一下，該試驗正在評估約 190 名患有或未患有糖尿病的受試者，他們以 1:2:2 的比例隨機接受 1.2 毫克、1.8 毫克培維肽或安慰劑，為期 48 週。關鍵療效終點是治療 24 週時 MASH 消退或纖維化改善，受試者再追蹤 24 週，總共 48 週，以確保安全性和生物標記反應。

Pemvidutide has the potential to be the first incretin agent to achieve statistical significance in MASH resolution and fibrosis improvement rates at only 24 weeks. Combined with the weight loss achieved with pemvidutide therapy, these results could position pemvidutide to become the standard of care in the treatment of MASH at the completion of the Phase 3 registrational program. As we continue to analyze the data from our completed clinical trials, it is increasingly clear that pemvidutide not only has a meaningful impact on body weight, but also the comorbidities associated with obesity.

Pemvidutide 有潛力成為第一個在僅 24 週內就在 MASH 緩解和纖維化改善率方面達到統計學顯著性的腸促胰島素藥物。結合pemvidutide療法實現的體重減輕，這些結果可能使pemvidutide成為3期註冊計劃完成後MASH治療的標準治療方法。隨著我們繼續分析已完成的臨床試驗的數據，越來越清楚的是，培維肽不僅對體重有有意義的影響，而且對與肥胖相關的合併症也有顯著影響。

We're particularly excited about the results from our Phase 2 MRI-based body composition substudy reported at the recent European Association for the Study of Diabetes Conference in September of this year. That study demonstrated class-leading preservation of lean mass of only 21.9% in subjects treated with pemvidutide as well as a preferential reduction in visceral adipose tissue. This type of fat has been associated with cardiovascular risk. The preservation of lean mass is a key factor in both the quantity, quality and sustainability of weight loss and will be the focus of one of our four Phase 3 studies.

我們對今年 9 月在歐洲糖尿病研究協會會議上報告的基於 MRI 的 2 期身體組成亞研究的結果感到特別興奮。該研究表明，接受培維肽治療的受試者的瘦體重僅保留了 21.9%，內臟脂肪組織優先減少，處於同類領先地位。這種類型的脂肪與心血管風險有關。維持瘦體重是減重數量、品質和永續性的關鍵因素，也是我們四項第三階段研究之一的重點。

As Vipin discussed, we completed our end-of-Phase 2 meeting with the FDA last week. This interaction resulted in an alignment with the agency on an innovative registrational program encompassing four pivotal Phase 3 studies, each designed to leverage a specific attribute of pemvidutide in the setting of weight reduction. Let me recap the planned design of the four trials that we outlined in last week's press release.

正如 Vipin 所討論的，我們上週完成了與 FDA 的第二階段結束會議。這種互動導致與該機構就一項創新註冊計劃達成一致，該計劃包括四項關鍵的 3 期研究，每一項都旨在利用培維肽的特定屬性來減輕體重。讓我回顧一下我們在上週的新聞稿中概述的四項試驗的計劃設計。

VELOCITY-1. This trial will assess the effects of pemvidutide on body weight in patients with obesity or overweight without diabetes. Other endpoints will include reductions in waist circumference, lipids, and blood pressure.

速度-1。該試驗將評估派維度勝肽對肥胖或超重但無糖尿病的患者體重的影響。其他終點包括腰圍、血脂和血壓的減少。

VELOCITY-2. This trial will assess the effects of pemvidutide on body weight and serum lipids in subjects with obesity or overweight and elevated LDL cholesterol levels. The study population will include a subset of subjects with elevated LDL cholesterol despite concomitant statin therapy. A large proportion of patients taking statins failed to achieve target LDL levels. And in a previous Phase 2 clinical trial in subjects with overweight or obesity, pemvidutide appeared to enhance LDL lowering effects in these subjects.

速度-2。該試驗將評估派維度勝肽對肥胖或超重以及低密度脂蛋白膽固醇水平升高受試者的體重和血脂的影響。研究族群將包括一部分儘管同時接受他汀類藥物治療但 LDL 膽固醇仍升高的受試者。有很大一部分服用他汀類藥物的患者未能達到目標 LDL 水平。在先前針對超重或肥胖受試者的 2 期臨床試驗中，pemvidutide 似乎增強了這些受試者的 LDL 降低效果。

VELOCITY-3. This trial will assess the effects of pemvidutide on body weight in subjects with obesity or overweight and elevated liver fat. Excess liver fat is highly prevalent in patients with obesity and is associated with an increased risk of cardiovascular disease.

速度-3。本試驗將評估派維度勝肽對肥胖或超重和肝脂肪升高受試者體重的影響。肝臟脂肪過多在肥胖患者中非常普遍，與心血管疾病風險增加有關。

VELOCITY-4. This trial will assess the effects of pemvidutide on body weight and body composition with emphasis on elderly individuals and individuals with sarcopenia at baseline. Functional measures and activities of daily living will also be assessed in this patient population.

速度-4。該試驗將評估培維肽對體重和身體組成的影響，並著重於老年人和基線患有肌少症的個體。也將對該患者群體的功能測量和日常生活活動進行評估。

The Phase 3 registrational VELOCITY program will evaluate three doses of pemvidutide, 1.2 milligrams, 1.8 milligrams, and 2.4 milligrams administered one weekly via subcutaneous injection over a 60-week treatment period. Collectively, the four trials are expected to enroll approximately 5,000 subjects, similar to past registrational programs in obesity. Our intention is to obtain regulatory approval for each of these doses, allowing patients to start on therapy on a pemvidutide dose with demonstrated efficacy for weight loss.

3 期註冊 VELOCITY 計劃將評估在 60 週的治療期內每週透過皮下注射給藥的三種劑量的 pemvidutide：1.2 毫克、1.8 毫克和 2.4 毫克。總共，這四項試驗預計將招募約 5,000 名受試者，類似於過去的肥胖註冊計畫。我們的目的是為每種劑量獲得監管部門的批准，使患者能夠開始接受已證明具有減肥功效的培維肽劑量的治療。

The successful completion of the FDA end-of-Phase 2 meeting for obesity represents an important milestone in the development of pemvidutide, not only de-risking the regulatory path for approval in obesity, but also positively impacting the development of pemvidutide in MASH and the additional indications we are pursuing.

FDA 肥胖症 2 期結束會議的成功完成代表了 pemvidutide 開發的一個重要里程碑，不僅降低了肥胖症批准監管路徑的風險，而且對 Pemvidutide 在 MASH 和 MASH 中的開發產生了積極影響我們正在尋找更多跡象。

We believe that pemvidutide has broad therapeutic potential beyond obesity and MASH. We are exploring up to three additional indications for which pemvidutide's profile as a balanced GLP-1 glucagon dual agonist may be ideally suited. We expect to submit an IND application for a Phase 2 clinical trial in the first indication by year-end with the study expected to initiate in the first half of 2025. We'll provide further information about these indications as regulatory discussions are completed.

我們相信，pemvidutide 具有超越肥胖和 MASH 的廣泛治療潛力。我們正在探索最多三個額外的適應症，pemvidutide 作為平衡的 GLP-1 胰高血糖素雙重激動劑可能非常適合這些適應症。我們預計在年底前提交第一個適應症的 2 期臨床試驗 IND 申請，該研究預計於 2025 年上半年啟動。監管討論完成後，我們將提供有關這些跡象的更多資訊。

With that, I'll now hand over the call to our acting Chief Financial Officer, Andrew Shutterly, to review our financial results for the third quarter. Andrew?

現在，我將把電話轉交給我們的代理財務長安德魯舒特利 (Andrew Shutterly)，以審查我們第三季的財務表現。安德魯？

Thank you, Scott, and good morning. For today's call, I will be providing a brief overview of Altimmune's third quarter 2024 financial and operating results. More comprehensive information will be available in our Form 10-Q to be filed with the SEC later today.

謝謝你，斯科特，早安。在今天的電話會議中，我將簡要概述 Altimmune 2024 年第三季的財務和營運業績。更全面的資訊將在今天稍後向 SEC 提交的 10-Q 表格中提供。

Altimmune ended the third quarter of 2024 with approximately $139.4 million of cash, cash equivalents, and short-term investments compared to $198 million at the end of 2023. We project that our existing cash will fund us well into the first half of 2026, which fully funds our IMPACT trial in MASH, including the expected readout of top-line biopsy data in the second quarter of 2025.

截至 2024 年第三季末，Altimmune 擁有約 1.394 億美元的現金、現金等價物和短期投資，而 2023 年底為 1.98 億美元。我們預計，我們現有的現金將為我們提供足夠的資金到 2026 年上半年，這將為我們在 MASH 中的 IMPACT 試驗提供充足的資金，包括預計在 2025 年第二季度讀出頂級活檢數據。

Research and development expenses were $19.8 million in the third quarter of 2024 compared to $18.4 million in the same period in 2023. Our R&D expenses for the third quarter of 2024 included approximately $12.4 million in direct costs related to development activities for pemvidutide and $0.8 million in direct costs related to additional research and discovery projects. General and administrative expenses were $5 million in the third quarter of 2024 versus $4.5 million in the third quarter of 2023. The increase was due primarily to a $0.4 million increase in professional services costs.

2024 年第三季的研發費用為 1,980 萬美元，而 2023 年同期為 1,840 萬美元。我們2024年第三季的研發費用包括約1,240萬美元與pemvidutide開發活動相關的直接成本和80萬美元與額外研究和發現專案相關的直接成本。2024 年第三季的一般及管理費用為 500 萬美元，而 2023 年第三季為 450 萬美元。這一增長主要是由於專業服務成本增加了 40 萬美元。

Included in the R&D and G&A costs for the third quarter of 2024 are approximately $3.1 million of noncash stock-based compensation expense compared to $2.7 million in the same period in 2023. Net loss for the three months ended September 30, 2024, was $22.8 million or a $0.32 net loss per share compared to a net loss of $20.7 million or $0.39 net loss per share for the third quarter of 2023.

2024 年第三季的研發和一般管理成本中包括約 310 萬美元的非現金股票補償費用，而 2023 年同期為 270 萬美元。截至 2024 年 9 月 30 日的三個月淨虧損為 2,280 萬美元，即每股淨虧損 0.32 美元，而 2023 年第三季的淨虧損為 2,070 萬美元，即每股淨虧損 0.39 美元。

I will now turn it back over to Vipin for his closing remarks. Vipin?

現在我將把它轉回給維平作總結發言。維賓？

Thank you, Andrew. And thank you for everything you have done serving as our acting CFO over the last several months.

謝謝你，安德魯。感謝您在過去幾個月作為我們的代理財務長所做的一切。

As Lee mentioned at the start of the call, Greg Weaver, who joined our team yesterday as Chief Financial Officer, is with us for the Q&A session. Welcome, Greg. Over a distinguished 25 year career, Greg has led the finance function at a number of public and private life sciences companies. We are excited to have him on board and look forward to benefiting from his deep expertise.

正如李在電話會議開始時提到的，昨天加入我們團隊擔任首席財務官的格雷格·韋弗 (Greg Weaver) 與我們一起參加了問答環節。歡迎，格雷格。在 25 年的傑出職業生涯中，Greg 曾領導多家上市和私人生命科學公司的財務職能。我們很高興他加入，並期待從他深厚的專業知識中受益。

We are encouraged by the significant strides we have made over the last several months. While we are in a fast-moving and highly competitive space, we are more confident than ever that pemvidutide has the potential to stand out from the crowd, and we believe that we are well equipped to seize the opportunity that lie ahead.

我們對過去幾個月的重大進展感到鼓舞。雖然我們身處一個快速發展且競爭激烈的領域，但我們比以往任何時候都更有信心，派維度勝肽有潛力脫穎而出，我們相信我們有能力抓住未來的機會。

That concludes our formal remarks. We would now like to open the lines to take questions. Operator?

我們的正式發言到此結束。我們現在願意開放提問線路。操作員？

(Operator Instructions)

（操作員說明）

Yasmeen Rahimi, Piper Sandler.

亞斯明·拉希米，派珀·桑德勒。

Good morning team. Congrats on all the updates and congrats, Greg, for joining a wonderful company and look very much forward to working closely with you. Team, really exciting that you got the VELOCITY studies aligned with the agency and kicking it off. I guess the question that we have for you is, now that you have the alignment, how important was the alignment in terms of strategic discussion and partnership? That's sort of question one.

早上好，團隊。恭喜所有更新，並祝賀格雷格加入一家出色的公司，並非常期待與您密切合作。團隊，非常令人興奮的是，你們讓 VELOCITY 研究與該機構保持一致並啟動了它。我想我們要問你的問題是，既然你們已經達成一致，那麼在策略討論和夥伴關係方面的一致有多重要？這是問題一。

Question two, are you still planning to -- if you're planning to kick off the studies, would they be occurring in a sequential order or at the same time?

問題二，你是否仍然計劃——如果你打算開始這些研究，它們會按順序進行還是同時進行？

And then the third question is, if you could shed some light on what are these additional indications you're potentially considering for which you're filing INDs, that would be helpful. And I'll jump back into the queue.

第三個問題是，如果您能闡明您可能考慮提交 IND 的這些額外跡像是什麼，那將會有所幫助。我會跳回到隊列中。

Thank you.

謝謝。

Yeah, thanks for the question. In terms of how important it is, this is really a significant and very important milestone for development of pemvidutide. I mean, this was a comprehensive review of our package so far, all of the studies that we have conducted. Very importantly, pemvidutide got a clean bill of safety, and Scott can talk more about that. And we have clear understanding as to what needs to be done, what are the full registrational trials that would lead to approval of the drug. So we think this is a very important milestone for pemvidutide for Altimmune and for our potential partners. Our strategy is to continue to look for a partnership centered around obesity, and we're moving full speed ahead with MASH and other indications.

是的，謝謝你的提問。就其重要性而言，這對pemvidutide的發展來說確實是一個意義重大且非常重要的里程碑。我的意思是，這是對迄今為止我們的一攬子計劃以及我們進行的所有研究的全面審查。非常重要的是，pemvidutide 獲得了明確的安全法案，斯科特可以更多地談論這一點。我們清楚地了解需要做什麼，以及哪些完整的註冊試驗將導致該藥物獲得批准。因此，我們認為這對 Pemvidutide 對於 Altimmune 和我們的潛在合作夥伴來說是一個非常重要的里程碑。我們的策略是繼續尋找以肥胖為中心的合作關係，並且我們正在全速推進 MASH 和其他適應症。

In terms of studies, the sequencing of them, ideally, they would all be run in parallel, but Scott can comment more about that as well as additional indications. We haven't really disclosed the details of additional indications at this point, but what I can say is that these are all designed to leverage the advantages of glucagon in pemvidutide has really focused around the properties of glucagon and some of the liver defatting and serum lipid improvement that we have seen from our MOMENTUM trial. We'll talk more about these indications once we have had regulatory alignment. We are planning to file our first IND later this year. And hopefully, we'll talk more about this 30 days after the IND clears the FDA.

就研究而言，理想情況下，它們的排序是並行進行的，但斯科特可以對此以及其他跡象進行更多評論。目前我們還沒有真正透露其他適應症的細節，但我可以說的是，這些都是為了利用派維度肽中胰高血糖素的優勢而設計的，真正關注的是胰高血糖素的特性以及一些肝臟脫脂和血清的特性。一旦我們達成監管一致，我們將更多地討論這些跡象。我們計劃在今年稍後提交第一份 IND。希望我們能在 IND 通過 FDA 批准 30 天後更多地討論這個問題。

Scott, can you provide some more color on the FDA interactions, as well as on the sequencing of the 3 indications -- sorry, the 4 VELOCITY trials?

Scott，您能否提供有關 FDA 相互作用以及 3 個適應症的排序的更多信息 - 抱歉，是 4 個 VELOCITY 試驗？

Sure. So the meeting was extremely successful. A lot of compliments were passed on the line during the meeting. And we have now exposed over 500 subjects to pemvidutide in completed trials. And based on that, the FDA looked at our safety profile and gave us a thumbs up on that exposure. Obviously, the final consideration is what you have at NDA, but no safety signals were identified from that interaction.

當然。所以這次會議開得非常成功。會議期間，網上傳來不少讚美之聲。目前，我們已完成試驗，讓 500 多名受試者接受了培維肽治療。基於此，FDA 審查了我們的安全狀況，並對我們的暴露給予了好評。顯然，最終考慮的是 NDA 中的內容，但沒有從該互動中識別出安全訊號。

They also confirmed our plan for the four studies, which did not include a diabetes trial, although we are including diabetics in our program, we'll have an ample number to evaluate, but they felt this was a reasonable approach and really like the idea of targeting the effects most likely to be impacted by glucagon, including the body composition study.

他們還確認了我們的四項研究計劃，其中不包括糖尿病試驗，儘管我們將糖尿病患者納入我們的計劃中，我們將有足夠的數量來評估，但他們認為這是一個合理的方法，並且非常喜歡這個想法針對最有可能受升血糖素影響的影響，包括身體組成研究。

Regarding the launching of the studies, the sequence is still to be determined as we look to operationalize that and hope to have more details for you in the near future.

關於研究的啟動，順序仍有待確定，因為我們希望將其付諸實施，並希望在不久的將來為您提供更多詳細資訊。

Thank you so much. I'll jump back in the queue.

太感謝了。我會跳回到隊列中。

Ellie Merle, UBS.

艾莉·梅爾，瑞銀。

This is Jasmine on for Ellie. Congratulations on all your progress. So thinking about the recent top-line GLP-1 ESSENCE trial data we saw in MASH and what we saw there on fibrosis, how are you thinking now about what you'd like to see from IMPACT in Q2? And what is really competitive now for incretins in the MASH space?

這是艾莉的茉莉花。恭喜您所取得的所有進步。因此，考慮一下我們在 MASH 中看到的最新 GLP-1 ESSENCE 試驗數據以及我們在纖維化方面看到的數據，您現在如何看待您希望從第二季度的 IMPACT 中看到的內容？對腸促胰素來說，現在 MASH 領域真正具有競爭力的是什麼？

Scott.

斯科特.

I think I heard you ask a question about the recently completed ESSENCE trial. Is that correct? Am I correct on that?

我想我聽到您問了有關最近完成的 ESSENCE 試驗的問題。這是正確的嗎？我的說法正確嗎？

Yes, yes. And just how you're -- how kind of that's impacted your thinking now about what's competitive for incretins in MASH?

是的，是的。您現在的情況對您現在關於 MASH 中腸降血糖素的競爭性的想法產生了怎樣的影響？

Right. Well, the trial results were as we expected. You have to recognize that the trial went for 72 weeks. It was longer than other trials, so a longer opportunity to see an effect because of the longer treatment. As well, the study power was increased by going over BARDA what was done in another Phase 3 program, so a large number of subjects in order to show that statistical significance. The treatment effect was modest. This is what we would expect from an agent like semaglutide that exerts its effects on liver fat indirectly through weight loss rather than direct effects on the liver. And as we've seen when glucagon has been in the mix or when there's a liver-targeted effect like FGF21, the liver fat and the endpoints move up considerably with more robust effects.

正確的。嗯，試驗結果正如我們所料。你必須承認審判持續了 72 週。它比其他試驗時間更長，因此由於治療時間更長，看到效果的機會也更長。此外，透過回顧 BARDA 在另一個第 3 階段專案中所做的事情，研究的力度也得到了提高，因此需要大量的受試者以顯示統計意義。治療效果有限。這是我們對像索馬魯肽這樣的藥物所期望的，它透過減肥間接地對肝臟脂肪產生影響，而不是直接影響肝臟。正如我們所看到的，當混合使用胰高血糖素或存在 FGF21 等肝臟靶向作用時，肝臟脂肪和終點會顯著上升，並產生更強勁的作用。

So moving forward to pemvidutide, the liver fat is what drives the MASH resolution and the fibrosis improvement. That should have been shown repeatedly in trials. We have class-leading liver fat reduction. The FGF21 showed meaningful and statistically significant effects in MASH resolution and fibrosis improvement at 24 weeks, their liver fat reduction was about 65%. We're at the 76% level. We have preclinical studies demonstrating a direct effect of pemvidutide on fibrosis that's independent of defatting, and we've done a number of other analyses suggesting success at 24 weeks.

因此，繼續使用培維肽，肝臟脂肪是推動 MASH 消退和纖維化改善的因素。這應該在試驗中反覆證明。我們擁有一流的肝臟減脂技術。FGF21 在 24 週時對 MASH 消退和纖維化改善顯示出有意義且具有統計意義的效果，其肝臟脂肪減少了約 65%。我們處於 76% 的水平。我們的臨床前研究表明，pemvidutide 對纖維化有直接影響，且與脫脂無關，我們還進行了許多其他分析，表明在 24 週時取得了成功。

So where do we stand in comparison to ESSENCE? If we are successful, and I believe we will, we will be the first incretin-based agent to show statistical significance, that is success on MASH resolution and fibrosis improvement at only 24 weeks. And combined with the weight loss associated with pemvidutide, the only agent at 24 weeks to offer weight loss because, as you are aware, the current compounds that have shown efficacy at 24 weeks have either been associated with no weight loss or actually even weight gain. And we believe that these combined effects will really put us at the front of the class in terms of the MASH drugs going toward approval.

那麼，與 ESSENCE 相比，我們處於什麼位置呢？如果我們成功了，我相信我們會成功，我們將成為第一個顯示出統計顯著性的基於腸促胰素的藥物，即僅在 24 週內就成功緩解了 MASH 並改善了纖維化。結合與培維度肽相關的體重減輕，培維度肽是唯一在24 週時提供體重減輕的藥物，因為如您所知，目前在24 週時顯示出療效的化合物要么沒有體重減輕，要么實際上甚至體重增加。我們相信，這些綜合作用將使我們在 MASH 藥物獲得批准方面真正處於同類領先地位。

Awesome. Thank you.

驚人的。謝謝。

I just want to add that really combining these two effects provides a complete solution for treating MASH. Not only we are going to show direct effect on the liver, but at the same time, it's a good thing in this patient population for patients to lose weight. So this combination -- there's a lot of discussion already about combination therapy. That's basically what we are doing with pemvidutide is providing a combination of direct liver-acting effect with weight loss.

我只是想補充一點，真正結合這兩種效果為治療 MASH 提供了完整的解決方案。我們不僅要顯示出對肝臟的直接影響，同時，對於該患者群體來說，減肥也是一件好事。因此，這種組合——已經有很多關於組合療法的討論。基本上，我們對培維肽所做的就是提供直接肝臟作用與減肥的組合。

Wonderful. Thank you.

精彩的。謝謝。

Liisa Bayko, Evercore.

莉莎·貝科，Evercore。

Hi, thanks for taking the question. Congrats on all the progress. Sort of two line of questions for me. First of all, I guess, as it relates to cardiac safety, do you think FDA views this as a class effect? And it might be something that sort of comes up as you talk about -- go back to FDA and discuss the fuller Phase 3 program, including MASH, which I think is what you intend to sort of prioritize yourselves. I'm just curious about that. Or is this something where they've seen something specific in the survodutide data? It just seems to me with the ratio that they have versus the ratio you have and the fact that you do have quite a bit of glucagon, I'm wondering if that's something that kind of gets revisited.

您好，感謝您提出問題。祝賀所有的進展。對我來說有兩行問題。首先，我想，因為它與心臟安全有關，您認為 FDA 是否認為這是一種階級效應？當你談論的時候，這可能會出現——回到 FDA 並討論更全面的 3 期計劃，包括 MASH，我認為這是你打算優先考慮的事情。我只是對此感到好奇。或者這是他們在 survodutide 數據中看到的特定內容？在我看來，他們的比例與你的比例以及你確實有相當多的胰高血糖素這一事實，我想知道這是否是一種需要重新審視的事情。

And then curious about the timing of the additional indications, really interesting concept. Are you going to wait for data from -- in MASH before initiating those and really taking off or when should we expect to learn more about that? Thanks.

然後對附加指示的時間感到好奇，這是一個非常有趣的概念。您是否要等待 MASH 中的數據，然後再啟動這些操作並真正起飛，或者我們應該何時了解更多相關資訊？謝謝。

Thanks, Liisa, let's take your first question first. Scott, do you want to get started?

謝謝，莉莎，讓我們先回答你的第一個問題。史考特，你想開始嗎？

Yeah. Liisa -- this is not a class effect. Repeatedly, in all of our trials, we've seen no evidence of arrhythmias, no evidence of any effects on coronary disease, cardiovascular disease, no MACE effects. And we've also seen no evidence of any changes on EKG intervals or the like. And we've seen this repeatedly in all of our studies. And we laid out all of the data for the FDA, and the FDA came to the same conclusion. So our conclusion would be that what's been described in the survodutide program is probably specific to the compound. And we achieved confirmation at the FDA that they agree on that opinion.

是的。莉莎——這不是階級效應。在我們所有的試驗中，我們一再強調，沒有發現心律不整的證據，沒有對冠狀動脈疾病、心血管疾病有任何影響的證據，也沒有發現 MACE 影響。我們也沒有看到心電圖間隔等發生任何變化的證據。我們在所有研究中都反覆看到了這一點。我們向 FDA 提供了所有數據，FDA 也得出了相同的結論。因此，我們的結論是，survodutide 計劃中描述的內容可能是該化合物特有的。我們得到 FDA 的確認，他們同意這一觀點。

Regarding the timing of the studies, we'll launch the study in the first half of next year. We'll have to see whether that actual launch goes before or comes after the MASH readout, and we'll have more information for you as we get into next year.

關於研究的時間安排，我們將在明年上半年啟動這項研究。我們必須看看實際的發射是在 MASH 讀數之前還是之後，在進入明年時我們將為您提供更多資訊。

One quick follow-up. Just can you remind us for survodutide, were those signals that they saw the increase in heart rate and all those things, were they early events or late events? In other words, do they happen after six months or earlier in the study?

一項快速跟進。您能否提醒我們 survodutide，這些訊號是否表明他們看到心率增加以及所有這些事情，它們是早期事件還是晚期事件？換句話說，它們是在研究的六個月後或更早發生的嗎？

Liisa, we don't know. What we know -- when we went to the FDA, we presented our whole program, and they did a comprehensive evaluation of the program. And again, they indicated no safety signals, and like all of the other sponsors that have proceeded in obesity, allowed us to design a program with purely efficacy trials. As you are aware, you need about 5,000 subjects in total to go to NDA and obesity that is exposed for a year. And we and other sponsors have usually achieved that by filling it up with efficacy trials, and that's what VELOCITY 1, 2, 3 and 4 is.

莉莎，我們不知道。我們所知道的——當我們去 FDA 時，我們展示了我們的整個計劃，他們對該計劃進行了全面的評估。再次，他們沒有表明任何安全信號，並且像所有其他在肥胖方面進行研究的贊助商一樣，允許我們設計一個純粹功效試驗的項目。如您所知，總共需要大約 5,000 名受試者才能接受 NDA 和暴露一年的肥胖症。我們和其他贊助商通常透過進行功效測試來實現這一目標，這就是 VELOCITY 1、2、3 和 4。

With the survodutide program, they've elected to conduct two smaller efficacy trials in a very large safety trial, which is actually designed to show no harm versus placebo, specifically to cardiac events. One would imagine that, that could be suggestive of a discussion that the company had with FDA. We don't know. So I really can't comment about the signal. What we can say is that the design of their program is unusual, and is oriented towards showing safety more than it is to show efficacy.

透過 survodutide 計劃，他們選擇在一項非常大的安全性試驗中進行兩項較小的療效試驗，該試驗實際上旨在顯示與安慰劑相比沒有任何危害，特別是對心臟事件。人們可能會認為，這可能暗示該公司與 FDA 進行了討論。我們不知道。所以我真的無法對信號發表評論。我們可以說的是，他們的程式的設計是不同尋常的，並且更注重顯示安全性而不是顯示功效。

And I think to be very clear, you asked a question about the Phase 3 program, this was a comprehensive interaction with the FDA, and there is no requirement for pemvidutide to do additional safety studies.

我想非常明確的是，您問了有關3期計劃的問題，這是與FDA的全面互動，並且不需要pemvidutide進行額外的安全性研究。

Xiaotong Jia, Jefferies.

賈曉彤，傑弗里斯。

Hi team. This is Fiona for Roger from Jefferies. My question is -- I have 2 questions regarding the 3 additional indications. First is, are -- I think I remember that you mentioned in the call that these indications you're going to carry forward independently or is it part of the ongoing conversation regarding partnerships? And I have a follow-up.

大家好。我是傑富瑞 (Jefferies) 的菲歐娜 (Fiona)，替羅傑 (Roger) 代言。我的問題是──我有 2 個關於 3 個附加適應症的問題。首先，我想我記得您在電話中提到您將獨立推進這些跡象，還是正在進行的有關合作夥伴關係對話的一部分？我有一個後續行動。

Yeah. Thank you for the question. Look, these indications have been designed to continue to improve or enhance the value of pemvidutide. The idea -- really, as we have said from the very beginning, pemvidutide has the potential for a pipeline in a product because of its many attributes. So they're all designed to really look at certain comorbidities of obesity, not obesity directly. And we believe they will not only create value for pemvidutide, these are indications we can pursue on our own, and they will be attractive to potential partners as well. So it's really designed to continue those discussions. And if a partnership can be built around these indications, we'll be very, very keen to do so, but we can also develop these on our own. So it really gives us a lot of flexibility, a lot of optionality as to how we move forward with these indications.

是的。謝謝你的提問。看起來，這些適應症的目的是為了繼續改善或增強pemvidutide的價值。這個想法——實際上，正如我們從一開始就說過的那樣，pemvidutide 由於其許多屬性而具有成為產品管道的潛力。因此，它們的目的都是為了真正研究肥胖的某些合併症，而不是直接研究肥胖。我們相信它們不僅會為pemvidutide創造價值，這些都是我們可以自己追求的跡象，而且它們也會對潛在的合作夥伴有吸引力。所以它的真正目的是為了繼續這些討論。如果可以圍繞這些適應症建立合作關係，我們將非常非常熱衷於這樣做，但我們也可以自己發展這些適應症。因此，對於如何推進這些跡象，它確實給了我們很大的靈活性和大量的選擇。

Got it. Thank you. That's very helpful. And my second question is, does the cash runway to one half '26 cover these three indications?

知道了。謝謝。這非常有幫助。我的第二個問題是，到 26 年一半的現金跑道是否涵蓋了這三個跡象？

Yes. The initial plans -- the initial IND filings as well as the initial Phase 2 type of trials that we would conduct around them, that the current cash will be sufficient for us to conduct these.

是的。最初的計劃——最初的 IND 申請以及我們將圍繞它們進行的最初的第二階段試驗，目前的現金足以讓我們進行這些。

Awesome. Thank you. Congrats on the quarter.

驚人的。謝謝。恭喜本季。

Thank you.

謝謝。

(Operator Instructions)

（操作員說明）

Karin Johnson, Goldman Sachs.

卡琳·約翰遜，高盛。

This is [Omar] on for Karin. I also have a couple of questions on the three indications. How are you thinking about which indications you'll select to move forward? And what are the size of each trials that you anticipate beginning in the first half of '25?

這是卡琳的[奧馬爾]。我對這三個適應症也有幾個問題。您如何考慮將選擇哪些跡象來推進？您預計在 25 年上半年開始的每項試驗的規模是多少？

Scott?

史考特？

The three indications are based on targets which would benefit from glucagon. These are all indications that involve subjects with obesity and overweight. And consequently, it has not only demonstrated an effect on these three specific targets, but also the effects of pemvidutide on body weight. So it has also implications for the obesity program as well. We'll provide further details about the indications once we have complete regulatory discussions. Hope to have that in the very near future.

這三個適應症是基於從胰高血糖素中受益的目標。這些都是涉及肥胖和超重受試者的跡象。因此，它不僅證明了對這三個特定目標的影響，而且還證明了培維肽對體重的影響。因此，它對肥胖計劃也有影響。一旦我們完成監管討論，我們將提供有關這些適應症的更多詳細資訊。希望在不久的將來能夠實現這一點。

Regarding the launching of the studies and the size of the studies, we'll provide more information again about that next year. We do expect to file the first IND by the end of this year, and to commence activities to launch that trial in the very near future. But I want to emphasize that these will not be Phase 1 studies. These will all be Phase 2 proof-of-concept studies. So we're really moving ahead into mid-stage development into all of these indications once the IND is clear.

關於研究的啟動和研究的規模，我們將在明年再次提供更多資訊。我們確實希望在今年年底之前提交第一份 IND，並在不久的將來開始啟動該試驗的活動。但我想強調的是，這些都不會是第一階段研究。這些都將是第二階段的概念驗證研究。因此，一旦 IND 明確，我們將真正進入所有這些適應症的中期開發階段。

Got it. Thank you.

知道了。謝謝。

Mayank Mamtani, B. Riley Securities.

Mayank Mamtani，B. Riley 證券。

Hi, good morning team. This is William on for, for Miami. Thanks for taking our questions and congratulations on the great quarter and and congratulations on the recently hiring of Greg. We have a couple of questions digging a little bit deeper, just kind of curious about the phase three essence data that we will be expecting at a sld coming up. I guess maybe what are you looking for specifically in that data that really could help provide or inform your confidence in your ongoing phase to impact study? Any any extra insight there could be could be helpful and then I have a follow up.

嗨，早上好，團隊。這是威廉在邁阿密的比賽。感謝您提出問題，祝賀這個季度的出色表現，並祝賀最近聘用了格雷格。我們有幾個問題需要深入挖掘，只是對我們在 sld 中期待的第三階段本質數據感到好奇。我想也許您在這些數據中特別尋找什麼真正可以幫助您提供或告知您對當前階段影響研究的信心？任何額外的見解都可能會有所幫助，然後我會進行跟進。

Yeah, William. Again, there were a lot of details that were not included in that initial readout, some of the questions about the statistical approaches, completers and the like. I don't think that really changes the way we view the study. We think the effects were predictable. We think the effects were modest, and represented the long duration of treatment and the super sizing of the study power.

是的，威廉。同樣，有許多細節沒有包含在最初的讀數中，一些關於統計方法、完成者等的問題。我認為這並沒有真正改變我們看待這項研究的方式。我們認為其影響是可以預見的。我們認為效果是適度的，並且代表了治療持續時間長和研究能力的超大規模。

So it would be of interest to see the details of that study. We certainly will watch the presentation with everyone else. But we really think the effects of the study are modest and that they speak to our having an even better readout to glucagon effects at a much earlier time point showing enhanced efficacy at a time point that cannot be hit by semaglutide. It would just be too soon to see those effects.

因此，了解研究的細節將會很有趣。我們當然會和其他人一起觀看演示。但我們確實認為這項研究的效果是適度的，並且它們說明我們在更早的時間點更好地讀出了胰高血糖素的效果，顯示在索馬魯肽無法達到的時間點增強了療效。現在看到這些影響還為時過早。

And then an additional question on your strategic partnerships. These have been going on for a little while now, beginning around the end of your Phase 2 MOMENTUM readout. I'm just kind of curious how your discussions with potential partnerships have evolved over time now that we're getting closer to Phase 2 impact, obviously, ESSENCE readout and now your three additional indications. Any color on the evolving conversation and if they're now starting to expand across multiple -- the broader potential of pemvidutide, any color on that would be helpful.

然後是關於你們的策略夥伴關係的另一個問題。這些情況已經持續了一段時間，從第二階段動量讀數結束時開始。我只是有點好奇，隨著時間的推移，您與潛在合作夥伴的討論是如何演變的，因為我們越來越接近第二階段的影響，顯然，本質讀出以及現在您的三個附加跡象。關於不斷發展的對話的任何顏色，如果它們現在開始擴展到多個領域——培維肽更廣泛的潛力，任何顏色都會有幫助。

Yeah, absolutely. Ray, do you want to take that question? Our Chief Business Officer, Ray, is here. So Raymond Jordt.

是的，絕對是。雷，你想回答這個問題嗎？我們的首席商務官雷就在這裡。所以雷蒙德·喬特。

As you mentioned, the strategic partner discussions we've been engaged with for the -- throughout the period of 2024, what's interesting, I think, is our approach has always been to continue to generate data and advance the programs. And why I say that is because the feedback, I think, we received generally has been from these companies that they're still trying to figure out their own strategic initiatives, how do they leverage their capabilities, what's their strategy to jump into obesity. And I think that feedback is fairly accurate because there have been no other deals that have been executed for now -- about 12 months now.

正如您所提到的，我們在 2024 年期間一直在進行策略合作夥伴討論，我認為有趣的是，我們的方法始終是繼續產生數據並推進專案。我之所以這麼說，是因為我認為我們收到的回饋通常來自這些公司，他們仍在試圖找出自己的策略舉措，他們如何利用自己的能力，他們的策略是什麼來跳入肥胖。我認為反饋相當準確，因為目前（大約 12 個月）沒有執行任何其他交易。

So I think the feedback we're receiving is genuine. I think other companies are still trying to figure out how they jump into it. And so I think what's important for us is to continue to generate the data, advance the programs, keep generating value for everyone. And I think things are starting to resonate. So again, the preservation of lean mass, I think that's a very unique attribute for pemvidutide, and that's been a hot topic in this space.

所以我認為我們收到的回饋是真實的。我認為其他公司仍在試圖弄清楚如何進入這個領域。因此，我認為對我們來說重要的是繼續產生數據，推進項目，不斷為每個人創造價值。我認為事情開始產生共鳴。再說一遍，保留瘦體重，我認為這是培維肽的一個非常獨特的屬性，也是這個領域的熱門話題。

The MASH indication, I think, is gaining even more traction, I think, with the Rezdiffra launch. I think more attention is being focused there. And again, Scott and Vipin have talked about how we believe we'll be positioned there with the combination of direct efficacy, 24 weeks and weight loss is going to be differentiating. And I think the additional indications is going to be something that will even create more value, broaden the offering (inaudible). So at a high level, I think these are the things that benefit our strategic partnering discussions as well as Altimmune in general.

我認為，隨著 Rezdiffra 的推出，MASH 適應症正在獲得更多關注。我認為更多的注意力正在集中在那裡。Scott 和 Vipin 再次談到了我們如何相信，透過將直接功效、24 週和減肥相結合，我們將能夠實現差異化。我認為額外的適應症甚至會創造更多價值，擴大產品範圍（聽不清楚）。因此，從較高的層面來看，我認為這些都是有利於我們的策略合作討論以及 Altimmune 整體發展的事情。

Thanks Ray. And I would just add that the conclusion of the end-of-Phase 2 meeting -- successful conclusion of the end-of-Phase 2 meeting is a very important milestone in moving these discussions forward. The path is clear now. We know how the program looks and what are the trial designs and how much it's going to cost really to take this to the finish line. So I think all that being in place, we are -- we'll continue to seek a partnership centered around obesity.

謝謝雷。我想補充一點，第二階段結束會議的結束——第二階段結束會議的成功結束是推動這些討論向前發展的一個非常重要的里程碑。現在道路已經清晰了。我們知道該計劃的外觀、試驗設計是什麼以及將其真正完成的成本是多少。因此，我認為所有這些都已到位，我們將繼續尋求以肥胖為中心的合作關係。

Got it very helpful. I'll hop back in the queue and congrats again on a very nice quarter.

得到它非常有幫助。我會重新加入隊列並再次祝賀這個非常美好的季度。

At this time, I would now like to turn the conference back over to Vipin Garg for closing remarks.

現在，我想將會議轉回維平·加爾格（Vipin Garg）進行閉幕致詞。

Thank you, everyone, for joining our call today. As always, we sincerely appreciate your continued support and interest in Altimmune as we work diligently to advance pemvidutide. Thank you again for your time. We look forward to updating you on our progress in the near future. Have a great rest of your day.

謝謝大家今天加入我們的電話會議。一如既往，我們衷心感謝您對 Altimmune 的持續支持和關注，因為我們正在努力推動 Pemvidutide 的發展。再次感謝您抽出時間。我們期待在不久的將來向您通報我們的最新進展。祝您有個愉快的一天。

This concludes today's conference call. Thank you for participating. You may now disconnect.

今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。