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Operator
Operator
Good day, ladies and gentlemen, and welcome to Altimmune, Inc. second quarter 2024 financial results conference call. (Operator Instructions) As a reminder, this call is being recorded. I would now like to introduce your host for today's conference call, Lee Roth of Burns McClellan, Investor Relations advisers to Altimmune. Lee, you may begin.
女士們、先生們,美好的一天,歡迎參加 Altimmune, Inc. 2024 年第二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。現在我想介紹一下今天電話會議的主持人,Altimmune 投資者關係顧問 Burns McClellan 的 Lee Roth。李,你可以開始了。
Lee Roth - Investor Relations
Lee Roth - Investor Relations
Thanks, Gigi. Good morning, everyone. Thank you for participating on the Altimmune second quarter 2024 financial results and business update conference call. Members of the Altimmune team joining me today are Vipin Garg, our Chief Executive Officer; Scott Harris, our Chief Medical Officer; Ray Jordt, our Chief Business Officer; Andrew Shutterly, our acting Chief Financial Officer; and Scot Roberts, our Chief Scientific Officer.
謝謝,吉吉。大家早安。感謝您參加 Altimmune 2024 年第二季財務業績和業務更新電話會議。今天加入我的 Altimmune 團隊成員包括我們的執行長 Vipin Garg; Scott Harris,我們的首席醫療官; Ray Jordt,我們的商務長; Andrew Shutterly,我們的代理財務長;和我們的首席科學官斯科特羅伯茨。
Following prepared remarks from Vipin, Scott Harris and Andrew, we'll hold a Q&A session. As a reminder, our press release with our Q2 2024 financial results was issued this morning and can be found on the IR section of the company's website.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 provisions under the Private Securities Litigation Reform Act of 1995.
在 Vipin、Scott Harris 和 Andrew 準備好發言後,我們將舉行問答環節。謹此提醒,我們的 2024 年第二季財務業績新聞稿已於今天上午發布,可在公司網站的 IR 部分找到。 1995 年《私人證券訴訟改革法案》中安全港條款的前瞻性聲明。
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 discussion of some of the risks and the factors that could impact the company's future results and operations, please refer to the risk factors and other cautionary statements contained in our filings with the SEC. I'll also direct you to read the forward-looking statement disclaimer in our press release issued earlier today and now available on our website.
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。有關可能影響公司未來業績和營運的一些風險和因素的討論,請參閱我們向 SEC 提交的文件中包含的風險因素和其他警告聲明。我還將指導您閱讀今天早些時候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。
Any statements made during this call speak only as of today's date, Thursday, August 8, 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.
本次電話會議期間發表的任何聲明僅代表今天(2024 年 8 月 8 日星期四)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。請注意,此通話正在錄音,並將在 Altimmune 網站上進行音訊重播。
With that, it's now my pleasure to turn the call over to Dr. Vipin Garg, Chief Executive Officer of Altimmune. Vipin?
現在,我很高興將電話轉給 Altimmune 執行長 Vipin Garg 博士。維賓?
Vipin Garg - President, Chief Executive Officer, Director
Vipin Garg - President, Chief Executive Officer, Director
Thanks, Lee. Good morning, everyone, and once again, thank you for joining us for our second quarter corporate update. In the second quarter and throughout the first half of the year, we continued to strengthen the rationale for pemvidutide as a highly differentiated therapeutic with significant potential in a variety of metabolic diseases. We are continuing to advance our key strategic clinical and operational priorities that are excited for the milestones that are approaching in both our obesity and MASH programs.
謝謝,李。大家早安,再次感謝您接受我們第二季的公司更新。在第二季和整個上半年,我們繼續強化派維度勝肽作為高度差異化治療藥物的理論基礎,在多種代謝疾病中具有巨大潛力。我們正在繼續推進我們的關鍵策略臨床和營運優先事項,這些優先事項對我們的肥胖和 MASH 計畫即將實現的里程碑感到興奮。
The quarter was highlighted by important data presentations at two of the most prominent medical meetings in our space. The American Diabetes Association or ADA's 84 scientific sessions and the European Association for the Study of the Liver or EASL Congress.
本季度的亮點是我們領域內兩次最著名的醫學會議上的重要數據演示。美國糖尿病協會 (ADA) 的 84 屆科學會議和歐洲肝臟研究協會 (EASL) 大會。
At the ADA meeting in June, we presented updated data on the effects of pemvidutide on body composition from our Phase 2 MOMENTUM obesity trial that demonstrated a class-leading preservation of lean mass among increasing agents. The preservation of lean mass and the quality of weight loss is becoming increasingly important for the treatment of obesity and for the safety and long-term maintenance of weight loss.
在 6 月的 ADA 會議上,我們展示了來自 2 期 MOMENTUM 肥胖試驗的 Pemvidutide 對身體組成影響的最新數據,該試驗證明了增肌劑在保持瘦體重方面處於領先水平。維持瘦體重和減肥品質對於肥胖治療以及減肥的安全和長期維持變得越來越重要。
In addition, we presented data during the ease of Congress that highlighted the disease-modifying potential of pemvidutide in MASH and reinforces our confidence in achieving both the MASH resolution and fibrosis endpoint in our Phase 2b IMPACT trial.
此外,我們在國會會議期間公佈了數據,強調了pemvidutide在MASH中改善疾病的潛力,並增強了我們在2b期IMPACT試驗中實現MASH解決和纖維化終點的信心。
We remain engaged in discussions regarding a global strategic transaction for pemvidutide, involving a variety of possible structures. We are intently focused on identifying and securing a partner with the right vision, resources and commitment to help us realize the full potential of pemvidutide in obesity, MASH and other metabolic conditions. In parallel, we intend to create additional value by completing the IMPACT study and pursuing additional indications for which pemvidutide especially well suited.
我們仍在參與有關pemvidutide全球戰略交易的討論,涉及各種可能的結構。我們專注於尋找和確保具有正確願景、資源和承諾的合作夥伴,以幫助我們充分發揮培維肽在肥胖、MASH 和其他代謝疾病方面的潛力。同時,我們打算透過完成 IMPACT 研究並尋求培維肽特別適合的其他適應症來創造額外價值。
Finally, we continue to prepare for the end of Phase 2 meeting with the FDA to review our registrational program for obesity. The outcome of this meeting will confirm the patient population, we believe will benefit most from the differentiated profile of pemvidutide.
最後,我們繼續為第二階段會議結束時與 FDA 的會議做準備,以審查我們的肥胖註冊計劃。這次會議的結果將確認患者群體,我們相信將從派維肽的差異化特徵中受益最多。
With that, I'll now turn the call over to our Chief Medical Officer, Dr. Scott Harris to provide additional updates and discuss our plans.
現在,我將把電話轉給我們的首席醫療官斯科特哈里斯博士,以提供更多更新並討論我們的計劃。
M. Scott Harris - Chief Medical Officer
M. Scott Harris - Chief Medical Officer
Thank you, Vipin. To provide a bit more information at some of the points you discussed, I'd like to turn to the data presented at recent scientific meetings. At the ADA meeting, Dr. Louis Aronne, one of the foremost experts in obesity and metabolic disease and principal investigator in our MOMENTUM obesity trial, presented data showing that pemvidutide led to nearly 16% weight loss at 48 weeks, with a direct trajectory suggesting additional weight loss with continued treatment.
謝謝你,維平。為了在您討論的一些問題上提供更多信息,我想談談最近科學會議上提出的數據。在ADA 會議上,Louis Aronne 博士是肥胖和代謝疾病最重要的專家之一,也是我們MOMENTUM 肥胖試驗的首席研究員,他提出的數據顯示,pemvidutide 在48 週時導致體重減輕近16%,其直接軌跡顯示持續治療可進一步減輕體重。
Dr. Aronne also presented updated body composition analysis that showed class-leading preservation of lean mass among incretin agents with only 21.9% of weight loss attributed to lean mass, while 78.1% of weight loss was associated with fat loss. Available data on other incretin-based weight loss agents have shown that lean mass loss can account for as much as 40% of the total weight loss.
Aronne 博士也介紹了最新的身體組成分析,顯示在腸促胰島素製劑中,瘦體重保持領先,只有 21.9% 的體重減輕歸因於瘦體重,而 78.1% 的體重減輕與脂肪減少有關。其他基於腸降血糖素的減肥藥的現有數據表明,去脂體重損失可佔總體重損失的 40% 之多。
The preservation of lean mass is becoming an increasingly important consideration in the management of obesity, as loss of lean mass has been associated with higher rates of bone fractures, reduced physical function and mortality. The data presented at ADA also demonstrated that pemvidutide has pronounced effects in serum lipids associated with cardiovascular risk.
維持瘦體重正在成為肥胖管理中越來越重要的考慮因素,因為瘦體重的損失與骨折發生率較高、身體功能下降和死亡率有關。ADA 公佈的數據還表明,pemvidutide 對與心血管風險相關的血脂有顯著影響。
In a subset of subjects with dyslipidemia, pemvidutide treatment led to a 55.8% reduction in triglycerides, 20% reduction in total cholesterol and 17.4% reduction in LDL cholesterol at the 2.4 milligram dose. Since dyslipidemia affects as many as 70% of obesity patients, we believe that pemvidutide could benefit a significant segment of the obesity population.
在患有血脂異常的受試者中,2.4 毫克劑量的培維肽治療使三酸甘油酯降低 55.8%,總膽固醇降低 20%,低密度脂蛋白膽固醇降低 17.4%。由於血脂異常影響多達 70% 的肥胖患者,我們相信培維肽可以使很大一部分肥胖者受益。
While significant cardiovascular benefits of weight loss were observed with GLP monotherapy in the recent SELECT trial, the effects on lipids were not clinically meaningful. We believe that with the robust reductions of serum lipids and liver fat observed with pemvidutide, we can achieve even greater degrees of cardiovascular benefit in this population.
雖然在最近的 SELECT 試驗中觀察到 GLP 單藥治療對減重有顯著的心血管益處,但對血脂的影響沒有臨床意義。我們相信,隨著培維肽顯著降低血清脂質和肝臟脂肪,我們可以在該族群中實現更大程度的心血管益處。
The narrative in the obesity space is evolving towards higher-quality weight loss, safe and effective maintenance and weight loss and the ability to directly address the comorbidities associated with obesity. We believe that pemvidutide with its excellent preservation of liver mass and its robust reductions in serum lipids and liver fat is well positioned compared with other agents.
肥胖領域的敘述正在朝著更高品質的減肥、安全有效的維持和減肥以及直接解決與肥胖相關的合併症的能力發展。我們相信,與其他藥物相比,pemvidutide 具有出色的肝臟質量保存能力以及對血清脂質和肝臟脂肪的強勁降低作用。
We will share a comprehensive package of these data with the FDA, as part of our upcoming end of Phase 2 meeting. We look forward to feedback from the FDA on our unique and differentiation driven approach to a Phase 3 program designed for obesity. We will provide an update on the outcome of this meeting when the dialogue with the FDA is complete.
作為即將舉行的第二階段會議結束的一部分,我們將與 FDA 分享這些數據的全麵包。我們期待 FDA 對我們針對肥胖症設計的第三階段計劃的獨特且差異化驅動的方法提供回饋。與 FDA 的對話完成後,我們將提供本次會議結果的最新資訊。
Turning to MASH. We presented data at the EASL Congress from a quantitative model that would predict a high likelihood of success in the upcoming IMPACT trial. In addition, an analysis of data in our Phase 1 trial of metabolic-associated steatotic liver disease, also known as MASLD demonstrated that higher proportions of subjects receiving pemvidutide, achieved improvements in FibroScan-aspartate aminotransferase or FAST score MRI-PDFF and alanine aminotransferase compared with subjects receiving placebo.
轉向 MASH。我們在 EASL 大會上展示了定量模型的數據,該模型可以預測即將到來的 IMPACT 試驗成功的可能性很高。此外,對代謝相關脂肪肝病(也稱為MASLD)的1 期試驗數據分析表明,與接受培維肽治療的受試者相比,FibroScan-天冬胺酸轉氨酶或FAST 評分MRI-PDFF 和丙氨酸轉氨酶的改善比例較高。
This suggests that significant rates of MASH resolution and fibrosis improvement may be achieved in the IMPACT Phase 2b MASH trial. We also presented data on the ability of pemvidutide, the lower serum lipid species associated with dyslipidemia in MASH, which reminds us that cardiovascular benefits of the primary cause of mortality in MASH patients.
這表明 IMPACT 2b 期 MASH 試驗可能會實現顯著的 MASH 消退和纖維化改善率。我們也提供了培維肽(與 MASH 血脂異常相關的較低血清脂質種類)能力的數據,這提醒我們心血管益處是 MASH 患者死亡的主要原因。
In addition, we recently published our results from the 12-week trial of pemvidutide in MASLD metabolic associated liver disease in the Journal of Hepatology, establishing the differentiated effects of pemvidutide in the treatment of MASLD and MASH. The safety and tolerability profile of pemvidutide was highlighted by the low 2.9% rate of adverse event discontinuations in this trial.
此外,我們最近在《肝病學雜誌》上發表了派維肽治療 MASLD 代謝相關肝病的 12 週試驗結果,確立了派維肽在治療 MASLD 和 MASH 中的差異化作用。該試驗中不良事件中止率低至 2.9%,凸顯了培維肽的安全性和耐受性。
With respect to impact, our enrollment is progressing well. If the 24-week efficacy endpoints are achieved, we believe the results could be transformative for the MASH therapeutic space, as we would demonstrate for the first time with rapid improvement in mass resolution and fibrosis improvement with an incretin agent in a 24-week time frame.
就影響力而言,我們的招生進展順利。如果實現 24 週療效終點,我們相信結果可能會為 MASH 治療領域帶來變革,正如我們首次證明,腸促胰島素藥物在 24 週內可快速改善腫塊分辨率並改善纖維化框架。
Finally, as we have discussed before, we are continuing to evaluate additional indications for pemvidutide that leverage the benefits of glucagon and that we believe will create additional value that will be attractive to strategic partners or allow us to develop on our own. We envision pursuing up to three additional indications for pemvidutide in our areas of greatest unmet medical need and we expect to provide more details later this year.
最後,正如我們之前所討論的,我們正在繼續評估培維肽的其他適應症,這些適應症可以利用胰高血糖素的益處,並且我們相信這將創造額外的價值,對戰略合作夥伴有吸引力或允許我們自行開發。我們預計在醫療需求未滿足的領域尋求最多三個額外的培維肽適應症,並預計在今年稍後提供更多細節。
With that, I'll now turn the call over to our acting Chief Financial Officer, Andrew Shutterly to review our financial results for the second quarter. Andrew?
現在,我將把電話轉給我們的代理財務長 Andrew Shutterly,以審查我們第二季的財務業績。安德魯?
Andrew Shutterly - Acting Chief Financial Officer
Andrew Shutterly - Acting Chief Financial Officer
Thank you, Scott, and good morning again everyone. For today's call, I'll be providing a brief update on Altimmune's second quarter 2024 financial and operating results. A 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,再次祝大家早安。在今天的電話會議中,我將簡要介紹 Altimmune 2024 年第二季的財務和營運業績。我們將於今天稍後向 SEC 提交的 10-Q 表格中提供更全面的資訊。
Altimmune ended the second quarter of 2024 with approximately $164.9 million of cash, cash equivalents and short-term investments compared to $198 million at the end of 2023. We project that our existing balance will fund us into the first half of 2026, which fully funds our IMPACT trial in MASH including the expected Q1, 2025 readout of top line biopsy data.
Altimmune 截至 2024 年第二季末的現金、現金等價物和短期投資約為 1.649 億美元,而 2023 年底為 1.98 億美元。我們預計現有餘額將為我們提供 2026 年上半年的資金,這將為我們在 MASH 中的 IMPACT 試驗提供全額資金,包括預計 2025 年第一季讀出的一線活檢數據。
Turning to the income statement. Revenue was negligible in the second quarter of 2024 and 2023. Any revenue reported during such period was for indirect rate adjustments on a government contract that we're closing now. Research and development expenses were $21.2 million in the second quarter of 2024 compared to $13.3 million in the same period in 2023.
轉向損益表。2024 年和 2023 年第二季的收入可以忽略不計。在此期間報告的任何收入都是我們現在即將關閉的政府合約的間接費率調整。2024 年第二季的研發費用為 2,120 萬美元,而 2023 年同期為 1,330 萬美元。
Approximately $14.8 million of this total for the second quarter of 2024 were direct expenses for the conduct of our clinical programs, including $13.8 million in direct costs related to development activities for pemvidutide and $1 million in direct costs related to the wind down and closing of HepTcell as announced on March 27, 2024.
2024 年第二季的總費用中約 1,480 萬美元是開展臨床項目的直接費用,其中包括與培維肽開發活動相關的 1,380 萬美元直接費用以及與 HepTcell 逐步結束和關閉相關的 100 萬美元直接費用2024 年3 月27 日宣布。
R&D expenses in the second quarter of 2023 included $5.6 million in direct expenses associated with the development of pemvidutide and $1.8 million in direct expenses related to HepTcell development activities. General and administrative expenses were $5.6 million in the second quarter of 2024 versus $4.8 million in the second quarter of 2023. The increase was due primarily to a $1 million increase in stock compensation expense caused by the modification of stock awards, partially offset by a $0.3 million reduction in insurance expenses.
2023年第二季的研發費用包括與pemvidutide開發相關的560萬美元直接費用和與HepTcell開發活動相關的180萬美元直接費用。2024 年第二季的一般及管理費用為 560 萬美元,而 2023 年第二季為 480 萬美元。這一增長主要是由於股票獎勵修改導致股票獎勵費用增加了 100 萬美元,但保險費用減少了 30 萬美元,部分抵消了增加。
Our quarterly non-cash operating expenses for the second quarter of 2024 was $4.4 million, all of which were recurring expenses. Net loss for the three months ended June 30, 2024 was $24.6 million or $0.35 net loss per share compared to a net loss of $16.1 million or $0.32 net loss per share for the second quarter of 2023. The increase in net loss in the quarter is primarily attributable to the $7.9 million increase in research and development expenses as we continue to execute the IMPACT Phase 2b trial in MASH.
我們 2024 年第二季的季度非現金營運費用為 440 萬美元,全部為經常性費用。截至 2024 年 6 月 30 日的三個月淨虧損為 2,460 萬美元,即每股淨虧損 0.35 美元,而 2023 年第二季的淨虧損為 1,610 萬美元,即每股淨虧損 0.32 美元。本季淨虧損增加的主要原因是,隨著我們繼續在 MASH 執行 IMPACT 2b 期試驗,研發費用增加了 790 萬美元。
I'll now turn it back over to Vipin for his closing remarks. Vipin.
現在我將把它轉回維平,讓他作結束語。維賓。
Vipin Garg - President, Chief Executive Officer, Director
Vipin Garg - President, Chief Executive Officer, Director
Thank you, Andrew. We are optimistic about the next steps for pemvidutide and are looking forward to the opportunities that lie ahead. With multiple upcoming milestones, we believe that we are well positioned for an exciting second half of the year and early 2025.
謝謝你,安德魯。我們對pemvidutide的下一步行動持樂觀態度,並期待未來的機會。隨著多個里程碑即將到來,我們相信我們已經準備好迎接令人興奮的下半年和 2025 年初。
Operator, that concludes our formal remarks, and we would like to open the lines to take questions.
接線員,我們的正式發言到此結束,我們願意開放線路來回答問題。
Operator
Operator
Thank you. (Operator Instructions)
謝謝。(操作員說明)
Yasmeen Rahimi, Piper Sandler.
亞斯明·拉希米,派珀·桑德勒。
Liam Hiester - Analyst
Liam Hiester - Analyst
This is Liam Hiester on for Yas. Just a few quick questions. So the first one, if you could kindly talk about the response rate in fibrosis and MASH resolution that you believe to be competitive in the MASH space? Secondly, what are your expectations for the dose response across the 1.2 milligram to 1.8-milligram dosing for biopsy endpoints.
我是亞斯隊的利亞姆·希斯特。只是幾個簡單的問題。那麼第一個問題,您是否可以談談您認為在 MASH 領域具有競爭力的纖維化和 MASH 解決方案的反應率?其次,您對活檢終點 1.2 毫克至 1.8 毫克劑量的劑量反應有何期望。
And then third, going into the end of Phase 2 meeting with the FDA, what are some key questions you plan to discuss with them? And if you can provide any color on which patient population you are considering for Phase 3 would be great.
第三,在與 FDA 的第二階段會議結束時,您計劃與他們討論哪些關鍵問題?如果您能提供您正在考慮進行第三階段的患者群體的任何顏色,那就太好了。
M. Scott Harris - Chief Medical Officer
M. Scott Harris - Chief Medical Officer
Itâs Scott Harris. Well thanks for the questions, Liam. So regarding the response rates for fibrosis and MASH resolution, it really depends on the placebo response that you see. So if you have a 30% placebo response, you're going to expect a much higher rate of say, MASH resolution or fibrosis improvement. And consequently, with a low placebo response rate you'd expect to lower. So to actually talk about response rates is difficult in that setting.
這是斯科特·哈里斯。好的,謝謝你的提問,利亞姆。因此,關於纖維化和 MASH 解決的反應率,它實際上取決於您看到的安慰劑反應。因此,如果您的安慰劑反應率為 30%,那麼您會期望 MASH 緩解或纖維化改善率會更高。因此,由於安慰劑反應率較低,您預計會降低。因此,在這種情況下,真正談論回覆率是很困難的。
Even looking at the delta over placebo really depends on where you start, as I just mentioned. The most important thing is that statistical significance is achieved. And I believe that we'll see not only statistical significance but meaningful response rates in both endpoints.
正如我剛才提到的,即使查看安慰劑與安慰劑的差異,也確實取決於你從哪裡開始。最重要的是達到了統計顯著性。我相信我們不僅會看到統計顯著性,還會看到兩個端點的有意義的回應率。
Regarding your second question on the dose response in MASH in the IMPACT trial, we believe that the 1.8-milligram dose will be the superior dose same as we saw the dose response in the MOMENTUM trial. And to remind you that the endpoints in MASH are driven predominantly by a reduction in liver fat. And the reduction in liver fat at the 1.8-milligram dose was substantially higher than the reduction of the 1.2 milligram dose. And we think that the endpoints in the MASH trial will follow that same pattern as well.
關於您關於 IMPACT 試驗中 MASH 劑量反應的第二個問題,我們認為 1.8 毫克劑量將是更好的劑量,與我們在 MOMENTUM 試驗中看到的劑量反應相同。並提醒您,MASH 的終點主要是由肝臟脂肪的減少所驅動的。1.8毫克劑量時肝臟脂肪的減少量明顯高於1.2毫克劑量時的減少量。我們認為 MASH 試驗的終點也將遵循相同的模式。
Lastly, regarding the end of Phase 2 meeting, the key questions that we're asking the FDA are about our study design, which we intend to bring out the differentiated profile of pemvidutide on lipids, liver fat, and body composition, because we believe that, this will differentiate pemvidutide in the marketplace.
最後,關於第二階段會議的結束,我們向FDA 詢問的關鍵問題是關於我們的研究設計,我們打算在研究設計中展示派維肽在脂質、肝臟脂肪和身體組成方面的差異化特徵,因為我們相信這將使pemvidutide在市場上脫穎而出。
So we are constructing our end of Phase 2 program and Phase 2 interaction with the FDA in the Phase 3 program, to basically bring out a target product profile that will be commercially attractive, and very differentiating from the other compounds in the space.
因此,我們正在建立第 2 階段計劃的結尾以及第 3 階段計劃中與 FDA 的第 2 階段互動,基本上是為了推出具有商業吸引力的目標產品概況,並且與該領域的其他化合物非常不同。
Operator
Operator
Roger Song, Jefferies.
羅傑·宋,杰弗里斯。
Unidentified Participant
Unidentified Participant
Hi. This is Cobbie -- on for Roger. Thanks for the question. Maybe following up on endpoints for your potential Phase 3 program. You discussed body fat, lipids, and liver, how are some ways you could differentiate or measure those end points in a way that are more nuanced or detailed than other companies can.
你好。這是科比——替羅傑出場。謝謝你的提問。也許會跟進您潛在的第 3 階段計劃的終點。您討論了身體脂肪、脂質和肝臟,以及如何以比其他公司更細緻的方式區分或測量這些終點。
And then secondly, perhaps on potential partnerships what are some attractive collaboration structures you're exploring? And at this point, do you match results at all factor into those partnership discussions? Thank you.
其次,也許在潛在的合作夥伴關係方面,您正在探索哪些有吸引力的合作結構?此時,您是否將結果與這些合作關係討論相符?謝謝。
M. Scott Harris - Chief Medical Officer
M. Scott Harris - Chief Medical Officer
Thanks Cobbie. I'll take the first question about the endpoints of the Phase 3 trial and I'll ask Vipin to answer the second question about the collaborations. So we think that the endpoints are fairly clear, because they represent meaningful clinical changes.
謝謝科比。我將回答有關第三階段試驗終點的第一個問題,並請 Vipin 回答有關合作的第二個問題。因此,我們認為終點相當明確,因為它們代表了有意義的臨床變化。
For example, serum lipids are a clear surrogate for cardiovascular risk, and there's been a very strong association of liver fat, with not only cardiovascular outcomes, but outcomes in a variety of other organs such as the kidney. So we believe that, simply demonstrating improvement of those endpoints will be very meaningful.
例如,血清脂質是心血管風險的明顯替代指標,而肝臟脂肪不僅與心血管結局密切相關,還與腎臟等多種其他器官的結局密切相關。因此,我們相信,僅僅展示這些端點的改進將是非常有意義的。
As we mentioned, we also have class-leading preservation of lean mass among the incretin agents either approved or in development. And we think that's extremely important as a stand-alone, because the loss of lean mass has been associated with loss of physical function fractures and also in some cases mortality. Many of these end points would take far larger trials to demonstrate, but we believe that they stand on their own as surrogates and are clinically meaningful. Vipin?
正如我們所提到的,在已批准或正在開發的腸促胰島素藥物中,我們在維持瘦體重方面也處於領先地位。我們認為,作為一個獨立的因素,這是極其重要的,因為瘦體重的損失與身體功能的喪失、骨折以及在某些情況下的死亡有關。其中許多終點需要更大規模的試驗才能證明,但我們相信它們本身可以作為替代指標,並且具有臨床意義。維賓?
Vipin Garg - President, Chief Executive Officer, Director
Vipin Garg - President, Chief Executive Officer, Director
Yeah. So with regards to the structure, I can't really get into the specific details of the structures, but we are open to multiple different structures. The focus is to get full value for the asset. As you know, pemvidutide is basically pipeline in a product.
是的。因此,關於結構,我無法真正深入了解結構的具體細節,但我們對多種不同的結構持開放態度。重點是獲得資產的全部價值。如您所知,pemvidutide 基本上是產品中的管道。
We have got two major indications that we are pursuing. So we want to make sure, we are able to capture the upside on both of those indications. So there are so many different ways to capture that value and structure the deal, so we are able to get full value for the asset.
我們有兩個正在追蹤的主要跡象。因此,我們希望確保我們能夠抓住這兩個跡象的上行空間。因此,有許多不同的方法來獲取價值並建立交易,因此我們能夠獲得資產的全部價值。
Operator
Operator
Seema Sheoran, Evercore.
Seema Sheoran,Evercore。
Seema Shoran - Analyst
Seema Shoran - Analyst
Hi. This is Seema on for Lisa. Thank you for taking my question. As you're expecting Phase 2 MASH data in first quarter, can you expand on how the enrollment is going and when you expect it to be complete? And my second question is, on oral pemvidutide. You have mentioned that, you plan to announce a candidate by year-end. Is that still the case? And what are some of the characteristics of this candidate that you are looking for? Thank you.
你好。這是西瑪為麗莎做的節目。感謝您回答我的問題。由於您預計第一季會出現第二階段的 MASH 數據,您能否詳細介紹註冊的進度以及預計何時完成?我的第二個問題是關於口服培維肽。您提到,您計劃在年底前宣布一位候選人。現在還是這樣嗎?您正在尋找的這位候選人有哪些特質?謝謝。
M. Scott Harris - Chief Medical Officer
M. Scott Harris - Chief Medical Officer
Thanks, Seema. I'll answer the first question. I'll ask Scot Roberts, to address the oral candidates. So enrollment is going extremely well. We've been told that we're enrolling this trial faster than any other mass trial and that represents the fact that the trial is attractive to patients because of the weight loss that it offers. So screening has not been a problem.
謝謝,西瑪。我來回答第一個問題。我將請史考特羅伯茲向口頭候選人發表演說。所以招生進展非常順利。我們被告知,我們註冊這項試驗的速度比任何其他大規模試驗都要快,這表明該試驗對患者很有吸引力,因為它可以減輕體重。所以篩檢不是問題。
We do intend to complete screening in the near future, and then we can provide you an update on the estimated date of the announcement of the trial results, which we still believe will be in the first quarter of 2025. Scot, did you want to address the question about the oral formulation?
我們確實打算在不久的將來完成篩選,然後我們可以向您提供有關試驗結果公佈的預計日期的最新信息,我們仍然認為將在 2025 年第一季度進行。Scot,您想解決有關口服製劑的問題嗎?
M. Scot Roberts - Chief Scientific Officer
M. Scot Roberts - Chief Scientific Officer
Sure. Good morning, Seema and thanks for the question. Our efforts on the oral formulation are continuing. We've actually expanded the number of types of formulations that we're looking at prototype formulations. We're still hopeful that, we can nominate one of these formulations for form of development by the end of the year.
當然。早安,西瑪,謝謝你的提問。我們在口服製劑方面的努力仍在繼續。實際上,我們已經擴大了我們正在研究的原型配方的配方類型數量。我們仍然希望,我們可以在今年年底之前提名其中一種方案作為開發形式。
I think that, and the oral formulation there's an important point that I do want to -- is that success with pemvidutide the peptide as an oral formulation is really (technical difficulty) we're seeing with the small molecule oral formulations which are obviously working, but the amount of weight loss and the overall potency, the adverse event profile of pemvidutide is well-established, and an oral formulation that delivers the peptide into the blood at equivalent concentrations to where we have the same profile.
我認為,對於口服製劑,我確實想要的一個重要點是,我們在小分子口服製劑中看到了勝肽作為口服製劑的成功(技術難度),這顯然是有效的,但體重減輕量和整體效力,pemvidutide 的不良事件特徵是明確的,並且口服製劑可以將勝肽以相同的濃度輸送到血液中,與我們具有相同的特徵。
So we're really very differentiated with respect to small molecules, which are clearly active but not really pushing the levels of weight loss that you see with the subcutaneous peptides, and also have higher rates of adverse events, as you know. So we still think this project is extremely valuable. The goal is to achieve a pemvidutide-like clinical profile with the oral formulation. So we'll update you as we know further advances there.
因此,我們在小分子方面確實非常與眾不同,這些小分子顯然具有活性,但並不能真正推動皮下肽的減肥水平,而且如您所知,不良事件發生率也更高。所以我們還是覺得這個專案是非常有價值的。目標是透過口服製劑實現類似培維肽的臨床特徵。因此,當我們了解那裡的進一步進展時,我們會向您通報最新情況。
Operator
Operator
Corinne Johnson, Goldman Sachs.
科琳·約翰遜,高盛。
Unidentified Participant
Unidentified Participant
Good morning. This is Omari on for Corinne. So we have a couple questions. In the past, you were established a partnership prior to seeking regulatory approval. Does that remain an aim, and how would you think about executing those next steps as provided by the agency after the partner? And then second, what is your wish list as you approach the agency for alignment on the end of Phase 2 meetings and prepare for future studies?
早安.這是為科琳代言的奧馬裡。所以我們有幾個問題。過去,您在尋求監管部門批准之前就已經建立了合作夥伴關係。這仍然是一個目標嗎?其次,當您與該機構聯繫以在第二階段會議結束時進行協調並為未來的研究做準備時,您的願望清單是什麼?
Vipin Garg - President, Chief Executive Officer, Director
Vipin Garg - President, Chief Executive Officer, Director
I'm sorry. Can you repeat your first question?
對不起。你能重複一下你的第一個問題嗎?
Unidentified Participant
Unidentified Participant
Sure. So in the past, you had wanted to establish a partnership prior to seeking regulatory approval. Does that remain an aim, and how would you want to think about executing those next steps provided by the agency without a partner?
當然。因此,過去,您希望在尋求監管部門批准之前建立合作夥伴關係。這仍然是一個目標嗎?
Vipin Garg - President, Chief Executive Officer, Director
Vipin Garg - President, Chief Executive Officer, Director
Oh, okay. I got it. So, sorry. So in terms of partnership prior to approval, I mean, look, our goal has always been to have a partner lined up before we start the Phase III development in obesity. In MASH, it's a different story. We think we can take it forward on our own in MASH, and part of the reason we are looking at these additional indications, that gives us additional flexibility, even in obesity-related indications.
哦好的。我得到了它。所以,抱歉。因此,就批准之前的合作而言,我的意思是,我們的目標始終是在開始肥胖症第三階段開發之前找到合作夥伴。在 MASH 中,情況則不同。我們認為我們可以在 MASH 中自行推進,我們正在研究這些額外適應症的部分原因是,這給了我們額外的靈活性,即使是在肥胖相關的適應症中。
So we'll see what feedback we get from the FDA at the end of Phase 2 meeting, as well as we have other interactions planned with the FDA to discuss the additional indications that we are evaluating, and once we have that information, we'll be able to make a better decision as to how to move forward.
因此,我們將看看在第二階段會議結束時從 FDA 得到什麼反饋,以及我們計劃與 FDA 進行其他互動,以討論我們正在評估的其他適應症,一旦我們獲得這些信息,我們就會‘將能夠就如何前進做出更好的決定。
M. Scott Harris - Chief Medical Officer
M. Scott Harris - Chief Medical Officer
Omari, this is Scott. I'm going to ask you to repeat the second question because I didn't hear it. The audio quality wasn't good enough. Could you please repeat the question?
奧馬裡,這是斯科特。我要請你重複第二個問題,因為我沒有聽到。音頻品質不夠好。您能重複一下這個問題嗎?
Unidentified Participant
Unidentified Participant
Sure. What is your wish list as you approach the agency for alignment on and in the Phase 2 meeting and prepare for future studies?
當然。當您與該機構聯繫以在第二階段會議上進行協調並為未來的研究做準備時,您的願望清單是什麼?
M. Scott Harris - Chief Medical Officer
M. Scott Harris - Chief Medical Officer
Well, I think this was partially addressed previously. So we believe that we have a highly differentiated compound. We believe that the obesity marketplace is going to segment with different patient needs. We stress repeatedly that 70% of the marketplace is dyslipidemic or high liver fat.
嗯,我認為這個問題之前已部分解決。所以我們相信我們擁有一種高度差異化的化合物。我們相信肥胖市場將根據不同的患者需求進行細分。我們一再強調,市面上有70%的人患有血脂異常或高肝脂肪。
So consequently, rather than saying, this is a program for the treatment of obesity, we're going to highlight that this is a program for the treatment of subjects with obesity with high serum lipids, high liver fat, and also people who might be subjects to the effects of excessive lean muscle loss.
因此,我們不是說這是一個治療肥胖的計劃,而是要強調這是一個治療高血脂、高肝脂肪的肥胖受試者以及可能患有肥胖症的人的計劃。 。
So what differentiates our End of Phase 2 discussion from others that may have preceded it is that we're not going in and saying this is an approval for obesity. We're saying this is an approval for obesity, focusing on the key attributes of pemvidutide that create our target product profile, which we will use to commercialize the compound. So I think that differentiation will not only be attractive in the marketplace, but for potential partners as well.
因此,我們的第二階段結束討論與之前可能進行的其他討論的不同之處在於,我們不會說這是對肥胖的批准。我們說這是對肥胖症的批准,重點關注pemvidutide的關鍵屬性,這些屬性創建了我們的目標產品概況,我們將利用該概況將該化合物商業化。因此,我認為差異化不僅對市場有吸引力,而且對潛在合作夥伴也有吸引力。
Operator
Operator
Mayank Mamtani, B. Riley Securities.
Mayank Mamtani,B. Riley 證券。
Unidentified Participant
Unidentified Participant
Hi. Thanks so much. This is actually William on for Mayank. Congratulations on the nice quarter. Just a couple questions from us. The first is I'm just kind of curious about the discontinuation rate variance that you've seen from prior Phase 2 trials, whether it be in MOMENTUM and diabetes, maybe even in your NAFLD earlier trial. Where are you expecting to land in your Phase 2 impact trial and maybe what you've been seeing so far?
你好。非常感謝。這實際上是威廉為 Mayank 所做的。恭喜您度過了美好的季度。我們只提出幾個問題。首先,我只是對您從先前的 2 期試驗中看到的停藥率差異感到好奇,無論是在 MOMENTUM 和糖尿病中,甚至可能在您的 NAFLD 早期試驗中。您期望在第二階段影響試驗中達到什麼效果?
M. Scott Harris - Chief Medical Officer
M. Scott Harris - Chief Medical Officer
Right. Well, thank you, William. So we believe that pemvidutide, at the completion of studies, will prove itself to be the best tolerated incretin agent, either approved or in development. We believe that based on the pharmacokinetics of the compound with the slow entry of drug into the bloodstream. And remember that any discontinuation rates we're seeing are essentially without any dose titration, which is really in stark contrast to other agents with titrating now up to 32 weeks. Our longest titration period was four weeks.
正確的。嗯,謝謝你,威廉。因此,我們相信,在研究完成後,無論是已批准的還是正在開發的,pemvidutide 將證明自己是耐受性最好的腸促胰島素藥物。我們認為,基於該化合物的藥物動力學,藥物緩慢進入血液。請記住,我們看到的任何停藥率基本上都沒有任何劑量滴定,這與目前滴定長達 32 週的其他藥物形成鮮明對比。我們最長的滴定期是四個星期。
And also, those adverse event discontinuation rates that were observed were without allowing for dose reduction, which was employed in as many as 30% of patients in the semaglutide and tirzepatide trials. So we have tremendous optionality in improving the tolerability of the compound going into Phase 3. And weâll discuss these options with the agency and get their feedback about the best approach. Previously, we had zero adverse event discontinuations in our diabetes trial.
而且,觀察到的不良事件停藥率是在不允許減少劑量的情況下發生的,而在索馬魯肽和替澤帕肽試驗中,多達 30% 的患者採用了劑量減少。因此,我們在提高進入第三階段的化合物的耐受性方面有巨大的選擇餘地。我們將與該機構討論這些選項,並獲得他們對最佳方法的回饋。此前,我們的糖尿病試驗中不良事件中止次數為零。
As we announced on the call today and in the publication in the Journal of Hepatology, the adverse event discontinuation rate in subjects who received pemvidutide in that trial was only 2.9%. And again, with the oddstock against the compound because of the relative absence of dose titration and the lack of dose reduction options.
正如我們今天在電話會議上以及在《肝病學雜誌》上發表的文章中所宣布的那樣,在該試驗中接受培維肽治療的受試者的不良事件中止率僅為 2.9%。再次,由於相對缺乏劑量滴定和缺乏劑量減少選擇,因此對該化合物產生了不利影響。
Now going forward, we have several options. One is to extend the titration period, and weâll seek feedback from the agency on that proposal. However, we believe that the 1.2 milligram dose, which has shown a 10% weight loss in clinical trials, does not need to be dose-titrated and can be administered directly to achieve the same 10% weight loss. This makes it a very attractive dose for primary care. That's a very, very attractive dose to give. We are also going to look for approval of the 1.8 and 2.4 milligram doses, as discussed in other discussions. with the community. But in addition, we will now allow for dose reduction, which is something that has been employed in other trials and that will going to employ going forward and it also mimics real-life use of these drugs.
現在展望未來,我們有多種選擇。一是延長滴定期,我們將尋求該機構對該提案的回饋。然而,我們認為,在臨床試驗中已顯示出10%體重減輕的1.2毫克劑量,不需要進行劑量滴定,直接給藥即可達到同樣10%的體重減輕效果。這使其成為初級保健中非常有吸引力的劑量。這是一個非常非常有吸引力的劑量。正如其他討論中所討論的,我們還將尋求 1.8 和 2.4 毫克劑量的批准。與社區。但此外,我們現在將允許減少劑量,這已在其他試驗中採用,並將在未來採用,它也模仿這些藥物的現實使用。
So consequently, we believe that we have a strong adverse event discontinuation rate, showing mainly in the diabetes and NAFLD populations. We have lots of tools and our trusts for improving further, we saw development of semaglutide and tirzepatide, 25% to 30% adverse discontinuation rates in their Phase 2 trials, which were reduced to single digits in Phase 3. We believe that like wise by employing the tools that are commonly used between Phase 2 and Phase 3 to adjust doses, we are going to have really nice adverse event discontinuation rates in our Phase 3 program, when it is finally read out.
因此,我們相信我們有很高的不良事件停藥率,主要表現在糖尿病和 NAFLD 族群。我們有許多工具和信任可以進一步改進,我們看到了索馬魯肽和替澤帕肽的發展,在其2 期試驗中不良停藥率達到25% 至30%,在3 期試驗中已降至個位數。我們相信,同樣,透過使用第 2 階段和第 3 階段之間常用的工具來調整劑量,當最終讀出時,我們將在第 3 階段計劃中獲得非常好的不良事件停藥率。
Unidentified Participant
Unidentified Participant
Got it. Very helpful. Appreciate that. And then just one extra, you got couple of presentations coming up at EASD. Specifically on the muscle data, you'll be presenting data on VAT, SAT, and TAT. I'm curious what exactly we may be expecting all doses, may be just give us little color on where or what we shoudl be expecting as far as muscle data? And then also, you could just remind me, how do you or do you have any plans to look into our functional benefit given that your showing the least amount of lean muscle mass loss in your patients?
知道了。非常有幫助。很欣賞這一點。另外,還有一點是,您將在 EASD 上進行幾場演講。特別是在肌肉數據方面,您將呈現有關 VAT、SAT 和 TAT 的數據。我很好奇我們到底期望所有劑量是什麼,可能只是給我們提供了一些關於我們應該在哪裡或應該期望什麼肌肉數據的資訊?然後,您也可以提醒我,鑑於您在患者中顯示出最少的瘦肌肉質量損失,您如何或您是否有任何計劃來研究我們的功能益處?
M. Scott Harris - Chief Medical Officer
M. Scott Harris - Chief Medical Officer
Yeah. Thanks for the question, William. So the details on the muscle [data], I'll come out in the presentation that we planned to make it easel. So Stay tuned. There's some preliminary information out there but you'll give a much more detailed presentation at that meeting in Madrid in September.
是的。謝謝你的提問,威廉。因此,有關肌肉[數據]的詳細信息,我將在我們計劃將其製作成畫架的演示文稿中公佈。所以請繼續關注。目前已經有一些初步信息,但您將在 9 月在馬德里舉行的會議上提供更詳細的演示。
But, again, at this point, we're leading in lean mass preservation among incretin agents, which we think is extremely important. Functional benefit is extermely important. And tha'ts the discussing this with the agency right now, in the design of a Phase 3 trial. So stay tuned. We hope to announce on that in near future.
但是,在這一點上,我們在腸促胰島素藥物中保持瘦體重方面處於領先地位,我們認為這非常重要。功能優勢極為重要。這就是現在與該機構在第三階段試驗設計中討論的問題。所以請繼續關注。我們希望在不久的將來宣布這一點。
Unidentified Participant
Unidentified Participant
Appreciate it. Thank you all. I'll hop back in the queue. Congratulations again.
欣賞它。謝謝大家。我會跳回到隊列中。再次恭喜。
Operator
Operator
Jon Wolleben, Citizens JMP.
Jon Wolleben,公民 JMP。
John Wolleben - Anaylst
John Wolleben - Anaylst
Hey. Good morning. Two questions from me. one, piggybacking on the last question, do we have any data or literature of thoughts on body composition changes and how those translate the -- anything clinically and any thought on how the differences you are seeing if it's a 30% versus 40% fat loss, what could that mean? Do you think that's a meaningful or functional changes?
嘿。早安.我有兩個問題。一,結合最後一個問題,我們是否有關於身體組成變化的任何數據或文獻,以及這些變化如何轉化為臨床上的任何內容,以及關於如果是30% 與40% 的脂肪減少,你所看到的差異的任何想法,這意味著什麼?您認為這是有意義的或功能性的改變嗎?
M. Scott Harris - Chief Medical Officer
M. Scott Harris - Chief Medical Officer
Yeah. Thanks, Jonathan. So there's limited data on the effects of changes in body composition. To these functional measures that William just asked about. We know that in population studies that low, lean body mass is associated with poor outcomes. Higher morbidity and mortality, and there's a wealth of data talking about that. Getting to not the actual amount of lean mass that you have, but the change, the best data that we have is from two studies.
是的。謝謝,喬納森。因此,關於身體組成變化的影響的數據有限。對於威廉剛才問到的這些功能性措施。我們知道,在人口研究中,低瘦體重與不良結果有關。更高的發病率和死亡率,並且有大量數據談論這一點。我們所掌握的最佳數據不是您所擁有的實際瘦體重,而是變化,來自兩項研究。
One is the look ahead trial of weight loss. Where lean mass loss was associated with bone fractures and this was also seen in the semaglutide select trial where they had a 40% loss of lean mass and in that trial a higher rate of pelvic and hip fractures that actually made it into the semaglutide label.
一是減肥的前瞻性試驗。瘦體重損失與骨折有關,這在索馬魯肽選擇試驗中也可見到,他們的瘦體重損失了40%,並且在該試驗中,骨盆和髖部骨折的發生率較高,這實際上已納入索馬魯肽標籤中。
So this is the data that we have. I think that we're going to be really developing and presenting a lot of new important data that we'll, we'll substantiate those benefits, but we do. The preservation of lean mass is extremely important. And I think we also have to look at the functional measures as was asked by Bill William, and that's a discussion that we'll have with the agency in the near future.
這就是我們擁有的數據。我認為我們將真正開發並提供許多新的重要數據,我們將證實這些好處,但我們確實這樣做了。維持瘦體重極為重要。我認為我們還必須考慮比爾威廉所要求的功能措施,這是我們將在不久的將來與該機構進行的討論。
And in terms of the meaningful differences, we know that visceral fat. And liver fat are associated with cardiovascular risk, and we're seeing very prominent reductions of both here with pemvidutide. So that combined with the loss of the reduction of serum lipids, not only the typical lipoproteins but all the cardio inflammatory lipids that we presented at the easel and the EDA meeting is going to result in an improved cardiovascular profile.
就有意義的差異而言,我們知道內臟脂肪。肝臟脂肪與心血管風險有關,我們發現培維肽可以顯著降低肝臟脂肪和心血管風險。因此,結合血清脂質減少的流失,不僅是典型的脂蛋白,而且我們在畫架和 EDA 會議上展示的所有心臟發炎脂質都將導致心血管狀況的改善。
We know that in the recent select trial there was a 20% reduction in Mace events associated with weight loss alone, but as I mentioned. The reduction of serum lipids with that agent is minimal, with some of glutamate generally around 3% reduction in total cholesterol, or LDL cholesterol may be as high as 5% of them studies that compares to the approximate 20% effects that we're getting with pemvidutide. So on top of the benefit that we're seeing with semaglutide and the selectron, we think we can do even better when a cardiovascular outcomes trial is conducted.
我們知道,在最近的選擇性試驗中,僅與減肥相關的梅斯事件就減少了 20%,但正如我所提到的。該藥物對血清脂質的降低幅度很小,一些谷氨酸鹽通常可降低總膽固醇 3% 左右,或者 LDL 膽固醇可能高達 5%,與我們得到的大約 20% 的效果相比,這些研究中與培維肽。因此,除了我們看到的索馬魯肽和 selectron 的益處之外,我們認為在進行心血管結果試驗時我們可以做得更好。
John Wolleben - Anaylst
John Wolleben - Anaylst
That makes sense. And my second question is you know if if a partnership doesn't take shape. How are you thinking strategically about potentially moving penalty forward yourself? It seems like an obesity phase three program might be, too large, but you mentioned three additional indications that could make sense. Can you talk a little bit about if a partial doesn't take place, the potential path forward for pemvidutide?
這是有道理的。我的第二個問題是,你知道合作關係是否沒有形成。您如何從戰略角度考慮自己是否有可能將點球向前推進?肥胖第三階段計劃似乎太大了,但你提到了三個可能有意義的額外跡象。您能談談如果部分試驗沒有發生的話,pemvidutide 的潛在前景嗎?
Vipin Garg - President, Chief Executive Officer, Director
Vipin Garg - President, Chief Executive Officer, Director
Yes, first of all, let me say Jonathan that we continue to be optimistic that we will have a partner lined up particularly after we have the outcome from the end of Phase 2 meeting because we're looking at some very interesting trial designs that we think will be very attractive to a partner.
是的,首先,讓我說喬納森,我們仍然樂觀地認為我們將有一個合作夥伴,特別是在我們得到第二階段會議結束的結果之後,因為我們正在考慮一些非常有趣的試驗設計,我們認為對合作夥伴來說非常有吸引力。
The name of the game here is to try to differentiate the idea of being fourth or fifth incretin-based agent for obesity how you're going to differentiate yourself? So I think that's what we are focused on. In our partnership discussions it's encouraging to see that our partners are also focused on that and they're getting the message. We're hearing it from a number of potential players, but they're looking for a differentiated asset in the obesity space.
這裡的遊戲名稱是嘗試區分第四種或第五種基於腸促胰島素的肥胖藥物的想法,您將如何使自己與眾不同?所以我認為這就是我們關注的重點。在我們的合作夥伴討論中,令人鼓舞的是,我們的合作夥伴也關注這一點,並且他們正在了解這一訊息。我們從許多潛在參與者那裡聽到了這樣的說法,但他們正在尋找肥胖領域的差異化資產。
So that's exactly what we are working on. So stay tuned. We're very bullish about our plans for a unique Phase 3 trial designed for pemvidutide for obesity. In addition as we have mentioned multiple times we are looking at additional indications that we can execute on our own. So that we're approaching it from multiple angles, but first and foremost we believe that we have a very differentiated asset and it will be attractive to a partner.
這正是我們正在努力的方向。所以請繼續關注。我們非常看好我們針對派維度勝肽治療肥胖症而設計的獨特 3 期試驗計劃。此外,正如我們多次提到的,我們正在尋找可以自行執行的其他跡象。因此,我們從多個角度來處理它,但首先也是最重要的是,我們相信我們擁有非常差異化的資產,並且它將對合作夥伴有吸引力。
John Wolleben - Anaylst
John Wolleben - Anaylst
Got it. Thanks again for taking the questions.
知道了。再次感謝您提出問題。
Operator
Operator
Thank you. At this time I would now like to turn the conference back over to Vipin Garg for closing remarks.
謝謝。現在我想將會議轉回維平·加爾格進行閉幕致詞。
Vipin Garg - President, Chief Executive Officer, Director
Vipin Garg - President, Chief Executive Officer, Director
Thank you everyone for joining our call today. As always we greatly appreciate this opportunity to share our meaningful developments and results with you and would like to thank you for your ongoing support. Have a wonderful rest of your day.
感謝大家今天加入我們的電話會議。一如既往,我們非常感謝有機會與您分享我們有意義的發展和成果,並感謝您一直以來的支持。祝您有個愉快的一天。
Operator
Operator
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。