ENDRA Life Sciences Inc (NDRA) 2024 Q1 法說會逐字稿

Good day, and welcome to the ENDRA Life Sciences first-quarter 2024 financial results conference call. (Operator Instructions) Please note this event is being recorded.

美好的一天，歡迎參加 ENDRA Life Sciences 2024 年第一季財務業績電話會議。（操作員說明）請注意此事件正在被記錄。

I would now like to turn the conference over to Yvonne Briggs. Please go ahead.

我現在想把會議交給伊馮·布里格斯。請繼續。

Thank you, operator. This is Yvonne Briggs with LHA. Good afternoon and welcome to ENDRA Life Sciences first-quarter 2024 business update and financial results conference call. Earlier today, ENDRA issued a press release on this topic, which is available in the Investor section of ENDRA's website.

謝謝你，接線生。我是 LHA 的伊馮布里格斯 (Yvonne Briggs)。下午好，歡迎參加 ENDRA Life Sciences 2024 年第一季業務更新和財務業績電話會議。今天早些時候，ENDRA 發布了有關此主題的新聞稿，可在 ENDRA 網站的投資者部分查看。

Before we begin, please note that today's discussion will include forward-looking statements. All statements by management, other than statements of historical facts, are forward-looking statements. These include statements regarding the company's strategies, financial condition, operations, costs, plans, and objectives, as well as anticipated results of development and commercialization efforts, the timing of clinical studies, potential partnership opportunities, and expectations regarding regulatory processes, receipt of required regulatory clearances, and product launches. Except as required by federal securities laws, the company disclaims any obligation to update or revise any forward-looking statements. Please refer to the company's Form 10-K for the 2023 fiscal year and subsequent SEC filings for more information about risks and uncertainties related to forward-looking statements.

在我們開始之前，請注意，今天的討論將包括前瞻性陳述。除歷史事實陳述外，管理階層的所有陳述均為前瞻性陳述。其中包括有關公司策略、財務狀況、營運、成本、計劃和目標的聲明，以及開發和商業化工作的預期結果、臨床研究的時間表、潛在的合作機會以及有關監管流程的期望、收到所需的資訊監管許可和產品發布。除聯邦證券法要求外，該公司不承擔更新或修改任何前瞻性聲明的義務。請參閱該公司 2023 財年的 10-K 表格以及隨後向 SEC 提交的文件，以了解有關前瞻性陳述相關風險和不確定性的更多資訊。

In terms of the structure of today's call, Francois Michelon, Chairman and Chief Executive Officer, will begin the prepared remarks, followed by Michael Thornton, ENDRA's Chief Technology Officer. Mr. Thornton will be followed by Irina Pestrikova, Senior Director of Finance, to review the first-quarter financial results, and then we'll take your questions.

就今天電話會議的結構而言，董事長兼執行長 Francois Michelon 將開始準備好的講話，隨後由 ENDRA 首席技術長 Michael Thornton 致辭。Thornton 先生將由高級財務總監 Irina Pestrikova 負責審查第一季的財務業績，然後我們將回答您的問題。

I'll now turn the call over to Francois Michelon. Francois?

我現在將把電話轉給弗朗索瓦·米其隆。弗朗索瓦？

Thank you, Yvonne, and thanks for joining us today to review ENDRA's first-quarter 2024 financial results and key business developments. We're advancing on our mission to revolutionize metabolic health with a practical detection and monitoring of liver disease, and we've made good progress in the following areas. First, activating new clinical research sites and target markets to build our body of clinical evidence at the local level across a range of sites, users, and patient types. This clinical data is a foundational element to achieving commercial success in the future.

感謝您，Yvonne，感謝您今天加入我們回顧 ENDRA 2024 年第一季財務業績和主要業務發展。我們正在推進透過肝臟疾病的實際檢測和監測來徹底改變代謝健康的使命，並且我們在以下領域取得了良好進展。首先，啟動新的臨床研究地點和目標市場，以在地方層面建立涵蓋一系列地點、使用者和患者類型的臨床證據。這些臨床數據是未來商業成功的基礎要素。

Second, working closely with the FDA to align on clinical requirements for our TAEUS systems De Novo application. A pre-submission meeting is scheduled with the FDA in suburban Washington, DC this quarter. Third, leveraging the accelerating market developments in the detection and treatment of liver disease to strengthen ENDRA's position. And fourth, looking beyond our current markets and technology to new opportunities to license our intellectual property. I'll elaborate on each of these elements.

其次，與 FDA 密切合作，以符合我們的 TAEUS 系統 De Novo 應用的臨床要求。計劃本季在華盛頓郊區與 FDA 舉行提交前會議。第三，利用肝病檢測和治療市場的加速發展來鞏固 ENDRA 的地位。第四，超越我們目前的市場和技術，尋找新的機會來授權我們的智慧財產權。我將詳細說明每個要素。

In the first quarter, we achieved a milestone in one of our target markets by installing the first TAEUS system in the United Kingdom. King's College Hospital in London, a prestigious national health service institution, is leading the introduction of ENDRA's liver system in the UK market. This partnership entails a clinical study comparing TAEUS's liver fat assessment accuracy versus MRI, the recognized research standard. The UK, along with other active clinical study sites in the US, are crucial for generating the body of clinical data needed to support the commercial adoption of our technology across radiology, hepatology, and endocrinology in global markets.

第一季度，我們在英國安裝了第一套 TAEUS 系統，在一個目標市場上實現了里程碑式的進展。倫敦國王學院醫院是著名的國家醫療服務機構，正在主導將 ENDRA 的肝臟系統引入英國市場。此次合作需要進行一項臨床研究，將 TAEUS 的肝臟脂肪評估準確性與公認的研究標準 MRI 進行比較。英國以及美國其他活躍的臨床研究中心對於產生支持我們的技術在放射學、肝病學和內分泌學在全球市場上的商業應用所需的臨床數據至關重要。

The clinical abstracts we presented last year at the European Association for the study of the liver were a great start, highlighting the impressive clinical performance of our technology compared to the MRI gold standard. But we need to continue to expand this pool of real-world evidence to demonstrate our clinical and economic value to potential users in our target markets at the local level. In addition to the foundational work of building our clinical evidence, ENDRA is working closely with the FDA to achieve alignment on clinical requirements for our TAEUS systems De Novo application. ENDRA has had several interactions with the agency since Q4 of 2023, and we've provided additional information about our technology and historical clinical testing.

我們去年在歐洲肝臟研究協會上提交的臨床摘要是一個很好的開端，強調了我們的技術與 MRI 金標準相比令人印象深刻的臨床表現。但我們需要繼續擴大這個現實世界證據庫，以向當地目標市場的潛在用戶展示我們的臨床和經濟價值。除了建立臨床證據的基礎工作外，ENDRA 還與 FDA 密切合作，以實現我們的 TAEUS 系統 De Novo 應用的臨床要求一致。自 2023 年第四季以來，ENDRA 已與該機構進行了多次互動，我們提供了有關我們的技術和歷史臨床測試的更多資訊。

To advance the review process and further align expectations, with the aim of ultimately achieving a successful regulatory outcome, ENDRA has scheduled an in-person pre-submission meeting with the FDA this quarter focusing on clinical requirements. Mike will elaborate on this in a minute.

為了推進審查流程並進一步調整期望，以最終取得成功的監管結果，ENDRA 已安排本季與 FDA 舉行現場提交前會議，重點討論臨床要求。麥克稍後將對此進行詳細說明。

On a broader market basis, key building blocks for diagnosing, treating, and managing liver disease are rapidly advancing, providing hope for the millions who are affected and opportunities for companies like ENDRA. Leading clinical societies such as the American Diabetes Association and the American Association for Clinical Endocrinology have updated their guidelines and now recommend screening for fatty liver disease for pre-diabetic, diabetic, and obese patients. That's over 100 million people in the US alone who need to be evaluated, and MRI is not a practical solution for a population this large.

在更廣泛的市場基礎上，診斷、治療和管理肝病的關鍵組成部分正在迅速發展，為數百萬受影響的人帶來了希望，也為 ENDRA 等公司帶來了機會。美國糖尿病協會和美國臨床內分泌學協會等領先臨床協會已更新其指南，現在建議對糖尿病前期、糖尿病和肥胖患者進行脂肪肝篩檢。光是在美國就有超過 1 億人需要接受評估，而 MRI 對於如此龐大的人口來說並不是一個實用的解決方案。

A second building block relates to the FDA's recent approval of Rezdiffra, Madrigal Pharmaceuticals' pioneering drug therapy for NAFLD/NASH, marking the beginning of a new chapter in liver disease management. This therapy, along with other emerging targeted treatments for liver disease will significantly impact healthcare providers, insurers and patients. Major insurers like Blue Cross are requiring adherence to nine specific prescribing authorization criteria for Rezdiffra, including an MRI-PDFF liver fat quantification exam which can only be performed by the most advanced subset of the world's MRIs. This underscores the complexity of managing this disease and highlights the need for precision in diagnosis and treatment.

第二個組成部分涉及 FDA 最近批准的 Rezdiffra，這是 Madrigal Pharmaceuticals 治療 NAFLD/NASH 的開創性藥物療法，標誌著肝病管理新篇章的開始。這種療法以及其他新興的肝病標靶治療將對醫療保健提供者、保險公司和患者產生重大影響。Blue Cross 等主要保險公司要求 Rezdiffra 遵守九項特定處方授權標準，其中包括 MRI-PDFF 肝臟脂肪定量檢查，該檢查只能由世界上最先進的 MRI 子集進行。這強調了治療這種疾病的複雜性，並強調了精確診斷和治療的必要性。

Rezdiffra and future drugs will consequently drive demand, we believe, for more accessible point-of-care diagnostic tools like ENDRA's TAEUS that are capable of facilitating the assessment and monitoring of liver disease, affecting over 2 billion people globally.

我們相信，Rezdiffra 和未來的藥物將因此推動對更容易使用的現場診斷工具（如 ENDRA 的 TAEUS）的需求，這些工具能夠促進肝病的評估和監測，影響全球超過 20 億人。

Finally, we're actively exploring collaborations and strategic pathways to expand the applications of our TAEUS platform beyond the liver. By leveraging our intellectual property and engaging in strategic partnerships and out-licensing initiatives, we aim to capitalize on the potential of ENDRA's platform in new therapeutic areas. We've engaged PatentVest, a leading intellectual property advisory firm to spearhead ENDRA's IP valuation, competitive landscape analysis, and licensing efforts. To that end, we're aggressively expanding our global intellectual property portfolio with the issuance of eight new patents so far this year. With these additions, ENDRA's patent estate reached an impressive 80 issued patents worldwide. These patents safeguard key innovations that are integral to the TAEUS system and reinforce our competitive edge in the marketplace.

最後，我們正在積極探索合作和策略途徑，以將我們的 TAEUS 平台的應用擴展到肝臟之外。透過利用我們的智慧財產權、參與策略合作夥伴關係和對外許可計劃，我們的目標是充分利用 ENDRA 平台在新治療領域的潛力。我們聘請了領先的智慧財產權顧問公司 PatentVest 來領導 ENDRA 的智慧財產權評估、競爭格局分析和授權工作。為此，我們正在積極擴大我們的全球智慧財產權組合，今年迄今已頒發了八項新專利。透過這些新增項目，ENDRA 的專利資產在全球已授權專利達到 80 項，令人印象深刻。這些專利保護了 TAEUS 系統不可或缺的關鍵創新，並增強了我們在市場上的競爭優勢。

I'll now turn the call over to Mike Thornton for an overview of our clinical and regulatory advancements. Mike?

我現在將電話轉給 Mike Thornton，以概述我們的臨床和監管進展。麥克風？

Thanks, Francois. Today, I'll provide an update on regulatory developments for ENDRA's TAEUS system. ENDRA has secured a valuable opportunity for an in-person pre-submission meeting in the second quarter with the FDA at their Maryland facility to prepare and submit a new De Novo application. The focus of this meeting will be clinical trial design that is crucial for obtaining alignment with the FDA on our study design. We'll discuss key aspects, including the study design, study hypothesis, and the statistical analysis plan.

謝謝，弗朗索瓦。今天，我將提供有關 ENDRA TAEUS 系統監管動態的最新資訊。ENDRA 獲得了寶貴的機會，可以在第二季度與 FDA 在馬裡蘭州工廠舉行現場提交前會議，以準備和提交新的 De Novo 申請。本次會議的重點是臨床試驗設計，這對於我們的研究設計與 FDA 保持一致至關重要。我們將討論關鍵方面，包括研究設計、研究假設和統計分析計劃。

Further, we've provided the FDA with a detailed description of the device and a master protocol that outlines the clinical study across multiple sites. This proposed study will cover a range of liver fat percentages mirroring the prevalence of steatotic liver disease in the US population. ENDRA's pre-submission team for the upcoming meeting includes key technical staff and an experienced regulatory lead with over 20 years of first of a kind medical device experience, a senior biostatistician that is familiar to the FDA, and several radiology clinical experts.

此外，我們還向 FDA 提供了該設備的詳細說明以及概述跨多個站點的臨床研究的主方案。這項擬議的研究將涵蓋一系列肝臟脂肪百分比，反映美國人群脂肪肝疾病的盛行率。ENDRA 即將召開的會議的預提交團隊包括關鍵技術人員和經驗豐富的監管領導（擁有 20 多年的同類醫療器材經驗）、FDA 熟悉的高級生物統計學家以及幾位放射學臨床專家。

Why is ENDRA's approach different this time? Reflecting on our past regulatory strategies and the fast-evolving medical imaging regulatory landscape, it's clear that ENDRA's historical reliance on clinical data derived from multiple feasibility studies was insufficient for FDA's current standards. The current approach is to work hand in hand with the FDA through its pre-submission process to develop a prospective statistically-powered pivotal trial whose data will be acceptable to FDA for our De Novo grants. We look forward to updating you on the outcomes of our FDA meeting and the next steps in our regulatory process.

為什麼 ENDRA 這次的做法有所不同？反思我們過去的監管策略和快速發展的醫學影像監管格局，很明顯，ENDRA 歷史上對來自多項可行性研究的臨床數據的依賴不足以滿足 FDA 當前的標準。目前的方法是透過預先提交流程與 FDA 攜手合作，開發一項前瞻性統計支持的關鍵試驗，其數據將被 FDA 接受以獲得我們的 De Novo 資助。我們期待向您通報 FDA 會議的最新成果以及監管流程的後續步驟。

With that, I'll turn it over to Irina Pestrikova for our financial update. Irina?

接下來，我會將其轉交給伊琳娜·佩斯特里科娃 (Irina Pestrikova)，以獲取我們的最新財務資訊。伊琳娜？

Thank you, Mike. Turning now to a review of our recent financial performance. For the quarter ended March 31, 2024, our operating expenses decreased to $2.8 million from $2.9 million for the same period in 2023. The decrease was mainly due to lower research and development expenses.

謝謝你，麥克。現在回顧一下我們最近的財務表現。截至 2024 年 3 月 31 日的季度，我們的營運費用從 2023 年同期的 290 萬美元減少至 280 萬美元。減少的主要原因是研發費用減少。

Our research and development expenses decreased year over year by approximately $350,000 as we completed the development of our initial TAEUS product. Our sales and marketing expenses increased by approximately $57,000, mainly due to higher consulting fees. General and administrative expenses increased by approximately $134,000, mainly due to higher professional fees. Our net loss in the first quarter of 2024 was $2.8 million or $0.26 per share. This compares with a net loss of $2.9 million or $0.93 per share in the first quarter of 2023.

隨著我們完成了最初的 TAEUS 產品的開發，我們的研發費用比去年同期減少了約 35 萬美元。我們的銷售和行銷費用增加了約 57,000 美元，主要是由於諮詢費用增加。一般及行政費用增加約 134,000 美元，主要是因為專業費用增加。我們 2024 年第一季的淨虧損為 280 萬美元，即每股 0.26 美元。相比之下，2023 年第一季的淨虧損為 290 萬美元，即每股淨虧損 0.93 美元。

Cash and cash equivalents were $1.1 million as of March 31, 2024. In the first quarter, the company raised $420,000 in gross proceeds from the sale of common stock through at the market equity facility and $77,000 from the exercise of warrants. We're focused on managing our current resources and financing opportunities to maintain the capital necessary to progress our operating plan.

截至 2024 年 3 月 31 日，現金及現金等價物為 110 萬美元。第一季度，該公司透過市場股權融資出售普通股籌集了 42 萬美元的總收益，並透過行使認股權證籌集了 77,000 美元的總收益。我們專注於管理我們目前的資源和融資機會，以維持推進我們的營運計劃所需的資本。

Now I'll turn the call back to Francois.

現在我將把電話轉回給弗朗索瓦。

Thanks, Irina and Mike. In summary, we remain committed to driving innovation in a market presence through the following four levers. Number one, leveraging clinical partner sites in Europe and the US to build our base of clinical evidence and achieve successful adoption of our technology. Number two, engaging closely with the FDA to advance our regulatory submission in the US. Number three, leveraging the accelerating market developments in the detection and treatment of liver disease to strengthen ENDRA's position. And fourth, leveraging our intellectual property to grow beyond our current markets and clinical focus.

謝謝伊琳娜和麥克。總之，我們仍然致力於透過以下四個槓桿來推動市場創新。第一，利用歐洲和美國的臨床合作夥伴站點來建立我們的臨床證據基礎並成功採用我們的技術。第二，與 FDA 密切合作，推進我們在美國的監管提交。第三，利用肝病檢測和治療領域不斷加速的市場發展來鞏固 ENDRA 的地位。第四，利用我們的智慧財產權超越我們目前的市場和臨床重點。

On behalf of the entire ENDRA team, once again I extend my thanks to the shareholders for their continued support of ENDRA. And now, operator, we're ready to open the call to questions.

我謹代表整個 ENDRA 團隊，再次感謝股東們對 ENDRA 的持續支持。現在，接線員，我們準備好開始提問。

(Operator Instructions) Edward Woo, Ascendiant Capital.

（操作員指令）Edward Woo，Ascendiant Capital。

Yeah, thank you very much for the update. My question is on Asia. I know you have the distribution in Vietnam that will go live as soon as you get FDA approval. Is there any other parts of Asia that you're possibly thinking to go into?

是的，非常感謝您的更新。我的問題是關於亞洲的。我知道你們在越南有分銷，一旦獲得 FDA 批准就會上線。您可能會考慮去亞洲其他地區嗎？

Thanks, Ed. Great question. I think to put it in context before I get to any specifics on Asia, as a small company we have to focus our resources. Obviously, we're starting strongly in Europe with the CE mark. The UK clinical site is our anchor there, and as we've announced, we plan to carefully add more sites in our target markets, resources permitting and then concurrently manage the FDA process and the three active sites we have in the US on a pre-FDA basis to prepare the US market.

謝謝，艾德。很好的問題。我認為在討論有關亞洲的任何具體情況之前，先將其放在背景中，作為一家小公司，我們必須集中我們的資源。顯然，我們在歐洲憑藉 CE 標誌強勢起步。英國臨床中心是我們在那裡的錨點，正如我們所宣布的，我們計劃在資源允許的情況下，在我們的目標市場中謹慎地添加更多臨床中心，然後同時管理FDA 流程和我們在美國的三個活動中心。

You're absolutely right, we've disclosed that we do have a distribution agreement in Vietnam which is surprisingly high-growth and high-populated market and we're happy for that. That would go into effect upon FDA approval. And we also previously announced years ago or rather a couple of years ago the agreement we signed with Shanghai General Hospital as a clinical study site in the PRC. So we're definitely looking at Asia. We have a few anchor points through those two mechanisms.

您說得完全正確，我們已經透露，我們確實在越南簽訂了分銷協議，這是一個令人驚訝的高成長和人口眾多的市場，我們對此感到高興。該規定將在 FDA 批准後生效。我們之前也宣布了幾年前，或者更確切地說幾年前，我們與上海人民醫院簽署了作為中國臨床研究中心的協議。所以我們肯定會關注亞洲。透過這兩種機制我們有一些錨點。

Asia obviously is a large market where liver disease is quite prevalent, but I would say that -- I'd like investors to hear first and foremost discipline and focus on being successful first in Europe, then in the US, and leveraging then carefully with all that knowledge and the base of clinical evidence that I've mentioned, which would be foundational for it all to then go to Asia. So I hope that helps answer your question.

亞洲顯然是一個肝臟疾病相當普遍的大市場，但我想說的是——我希望投資者首先聽到的是紀律，並專注於首先在歐洲取得成功，然後在美國，然後小心地利用我提到的所有知識和臨床證據基礎，這將是這一切進入亞洲的基礎。所以我希望這有助於回答你的問題。

Yes, it does. I wish you good luck with the FDA meeting, and thank you. And I wish you guys good luck. Thank you.

是的，它確實。祝您在 FDA 會議上一切順利，謝謝。我祝你們好運。謝謝。

Thank you so much, Ed. Operator, if we don't have any other questions, I think we can wrap up the call then.

非常感謝你，艾德。接線員，如果我們沒有其他問題，我想我們就可以結束通話了。

Thank you. This concludes the conference. Thank you for attending today's presentation. You may now disconnect.

謝謝。會議到此結束。感謝您參加今天的演講。您現在可以斷開連線。

Thank you, everyone.

謝謝大家。