Entera Bio Ltd (ENTX) 2022 Q1 法說會逐字稿

Greetings, and welcome to Entera Bio's First Quarter '22 Update Conference Call. (Operator Instructions) As a reminder, this conference is being recorded. I would now like to turn the call over to (inaudible) of Investor Relations. Thank you. You may begin.

大家好，歡迎參加 Entera Bio 2022 年第一季業績更新電話會議。 （接線員指示）提醒一下，本次會議正在錄音。現在我想將電話會議轉給投資人關係部門的（聽不清楚）。謝謝。您可以開始了。

Good morning, and welcome to the call. Joining me today are Spiros Jamas, our Chief Executive Officer; and Miranda Toledano, Chief Business Officer, Chief Financial Officer and Head of Strategy. A press release announcing Entera's financial and operating results for the first quarter ended March 31, 2022, was issued on May 12, 2022. For those of you who have not received it, it is available on the company's website in the Investors section at www.enterabio.com.

早上好，歡迎參加電話會議。今天與我一同出席的還有我們的執行長Spiros Jamas，以及首席商務官、財務長兼策略主管Miranda Toledano。 Entera於2022年5月12日發布了一份新聞稿，宣布了截至2022年3月31日的第一季財務和營運業績。尚未收到該新聞稿的人士，可在本公司網站www.enterabio.com的「投資者」欄位查閱。

Before we begin our prepared remarks, I would like to remind you that various statements the company makes during this call about future results and operations and financial positions, are -- or interpretations of data from completed and ongoing trials, business strategy and plans and objectives for the company's future operations are considered to be forward-looking statements within the meaning of the federal securities laws.

在我們開始準備好的發言之前，我想提醒大家，公司在本次電話會議上就未來業績、營運和財務狀況所作的各種陳述，或對已完成和正在進行的試驗的數據、業務戰略以及公司未來運營的計劃和目標的解釋，均被視為聯邦證券法所定義的前瞻性陳述。

Our forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Specifically, developments related to the COVID-19 pandemic continue to evolve, and the extent to which the pandemic will impact us in the future will depend on the duration and magnitude of such impact and on numerous factors that we may not be able to accurately predict. These risks are described more fully in the company's SEC filings and are available on the SEC EDGAR system and on the website.

我們的前瞻性陳述是基於目前的預期，其中涉及風險、情況變化、假設和不確定性。具體而言，與COVID-19疫情相關的事態發展持續演變，未來疫情對我們影響的程度將取決於其持續時間和程度，以及諸多我們可能無法準確預測的因素。這些風險在公司提交給美國證券交易委員會（SEC）的文件中進行了更詳細的描述，並可在SEC EDGAR系統和公司網站上查閱。

We encourage all investors to read the company's SEC filings. All information we provide on this call is provided only as of today, and we may undertake no obligation to update any forward-looking statements we may make on this call on account of new information, future events or otherwise.

我們鼓勵所有投資者閱讀公司提交給美國證券交易委員會 (SEC) 的文件。我們在本次電話會議上提供的所有資訊僅截至今日，我們不承擔因新資訊、未來事件或其他原因而更新本次電話會議上可能做出的任何前瞻性陳述的義務。

Finally please be advised that today's call is being recorded and webcast. I would now like to turn the call over to Spiros Jamas. Go ahead, Spiros.

最後請注意，今天的電話會議將被錄音並進行網路直播。現在我想將發言權交給Spiros Jamas。 Spiros，請發言。

Good morning, everyone. We're aiming to keep this call brief because we already circulated our earnings release last week. I am pleased to announce that joining me on the call today is Miranda Toledano. As we announced on Monday, Miranda, who has been a member of our Board of Directors since 2018 has now also become our Chief Business Officer and Chief Financial Officer. Miranda is an accomplished leader in biotechnology industry with almost 25 years of C-level strategic leadership and Wall Street experience.

大家早安。由於我們上週已經發布了財報，因此我們計劃簡短地進行這次電話會議。我很高興地宣布，米蘭達·托萊達諾 (Miranda Toledano) 也將參加今天的電話會議。正如我們週一宣布的那樣，米蘭達自2018年以來一直擔任我們董事會成員，現在她也擔任我們的首席商務官和首席財務官。米蘭達是生技產業經驗豐富的領導者，擁有近25年的C級策略領導經驗和華爾街經驗。

I believe that the company will benefit significantly with Miranda as part of our leadership team, and her strategic experience is a perfect fit as we progress with global partnership discussions and continue development of our proprietary oral delivery platform.

我相信，米蘭達加入領導團隊後，公司將受益匪淺，隨著我們推進全球合作夥伴關係討論並繼續開發專有口服給藥平台，她的策略經驗將與我們完美契合。

I'm happy to introduce Miranda Toledano.

我很高興介紹米蘭達·托萊達諾。

Thank you very much, Spiros, and good morning, everyone. I'm truly excited to join Entera at this critical juncture in the company's history. As you all know, our lead program, EB613 is moving along to Phase III clinical development. Last year, Entera reported compelling efficacy and safety data from our Phase II dose-ranging study. We believe EB613 has strong differentiation due to its unique oral route of administration, safety profile and mechanism of action, which is well validated for close to 20 years.

非常感謝Spiros，大家早安。我非常高興能夠在公司歷史上這個關鍵時刻加入Entera。眾所周知，我們的主要項目EB613正在推進III期臨床開發。去年，Entera報告了II期劑量範圍研究令人信服的療效和安全性數據。我們相信，EB613憑藉其獨特的口服給藥途徑、安全性和作用機制，以及近20年來的充分驗證，具有顯著的差異化優勢。

As such, we hope to position EB613 as the first oral anabolic agent for the treatment of postmenopausal women at high risk of osteoporosis. In addition, our analysis across community and specialist clinicians and early pre-commercial assessment to date points to a clear unmet need for an oral agent to significantly expand the PTH therapeutic class.

因此，我們希望將EB613定位為首個用於治療高風險停經後女性骨質疏鬆症的口服合成代謝藥物。此外，我們針對社區和專科醫生的分析以及迄今為止的早期上市前評估表明，口服藥物存在明顯的未滿足需求，從而顯著擴展甲狀旁腺激素（PTH）的治療類別。

We are currently laser-focused on finalizing our registrational study plans and dialogue with FDA, and we look forward to updating you on these plans and the earlier pipeline soon.

我們目前正專注於完成我們的註冊研究計劃和與 FDA 的對話，我們期待很快向您通報這些計劃和早期的研發流程。

I will turn it back to Spiros to provide highlights from Q1 2022, which the company released last week. Thank you.

我將把時間交回給 Spiros，分享該公司上週發布的 2022 年第一季業績亮點。謝謝。

Thank you, Miranda. As part of our pre-pivotal study planning, we completed a comprehensive market and analytics study concerning EB613 and its potential as the first oral anabolic and first oral PTH product available to postmenopausal women at high risk of osteoporosis. The study focused on understanding treatment paradigms and quantifying the U.S. market potential of EB613 by evaluating prescriber, health plan and managed care inputs.

謝謝你，米蘭達。作為我們關鍵性研究前期規劃的一部分，我們完成了一項關於EB613的全面市場和分析研究，探討其作為首個口服合成代謝類藥物和首個口服甲狀旁腺激素（PTH）產品的潛力，以應對骨質疏鬆症高風險停經後女性的需求。該研究旨在透過評估處方醫生、健康計畫和管理式醫療的投入，了解治療模式並量化EB613在美國的市場潛力。

The key conclusions from this study included: first, osteoporosis represents a large market of over 15 million patients in the U.S., yet approximately only 75% of the target population is not receiving any pharmacologic treatment. Second, despite endocrinologists recognizing the clinical benefit of initiating anabolic treatments such as the currently injectable PTH agents for high-risk patients prior to first-line bisphosphonates, their high cost and patient's unwillingness to opt for a subcutaneous injection is limiting treatment.

這項研究的主要結論包括：首先，骨質疏鬆症在美國代表著超過1500萬患者的龐大市場，但其中約75%的目標人口尚未接受任何藥物治療。其次，儘管內分泌學家認識到在一線雙磷酸鹽類藥物治療之前，對高風險患者進行合成代謝治療（例如目前可注射的甲狀旁腺激素 (PTH) 藥物）具有臨床益處，但其高昂的成本以及患者不願選擇皮下注射，限制了治療。

Clinicians were receptive to EB613's efficacy based on our Phase II data as an anabolic treatment and its improved safety profile and its oral route of administration. Payers surveyed were favorable to EB613 and characterize the value proposition as a safe oral anabolic treatment option for osteoporosis patients. A survey of high-prescribing doctors show that EB613 could become the preferred option in moderate-to-severe osteoporosis and substantially grow the anabolic market.

基於我們II期臨床試驗數據以及其作為合成代謝治療藥物的改善的安全性和口服給藥途徑，臨床醫生對EB613的療效持積極態度。受訪的付款人對EB613持正面態度，認為其價值主張是骨質疏鬆症患者安全的口服合成代謝治療選擇。一項針對處方量較大的醫生的調查顯示，EB613有望成為中度至重度骨質疏鬆症的首選藥物，並大幅推動合成代謝藥物市場的成長。

I'll now move to a brief update on our technology platform and IP. We filed multiple U.S. patent applications this quarter. We intended to expand our patent protection and support future developments as we continue to optimize our oral delivery platform. Furthermore, we continue to evaluate establishing material transfer agreements with potential strategic partners for proprietary molecules. Thank you very much for this update, and we look forward to taking your questions.

現在，我將簡要介紹我們的技術平台和智慧財產權。本季度，我們提交了多項美國專利申請。我們計劃擴大專利保護範圍，並支持未來的發展，同時繼續優化我們的口服給藥平台。此外，我們仍在評估與潛在戰略合作夥伴就專有分子建立材料轉讓協議的可能性。非常感謝您提供最新信息，我們期待您的提問。

(Operator Instructions) Our first questions come from the line of Kalpit Patel with B. Riley.

（操作員指示）我們的第一個問題來自 B. Riley 的 Kalpit Patel。

Congrats on the appointment, Miranda. Maybe first, I'll start with the analytical study for EB613. I guess did you collect any data that shows what -- did you collect any data that shows what percentage or portion of prescribers would utilize an agent like EB613 before bisphosphonates maybe in that patient group with no prior history of fractures.

恭喜米蘭達獲得任命。首先，我想先從EB613的分析研究說起。我想問一下，您是否收集了任何數據，可以顯示在既往沒有骨折病史的患者群體中，有多少比例的處方醫生會在使用雙磷酸鹽類藥物之前先使用EB613之類的藥物？

Thanks for your question. Yes, I mean, obviously, bisphosphonates are used as first line and a lot of the -- you have to go through a step therapy to bisphosphonates at first. But the -- what was interesting was that payers, I mean, and prescribers were -- with the profile that we have with an oral anabolic, they really see an oral PTH moving up the chain and then even not requiring a step edit for -- to be used in this population.

謝謝你的提問。是的，我的意思是，雙磷酸鹽顯然是一線藥物，而且許多患者一開始必須經過雙磷酸鹽的階梯式治療。但有趣的是，付款人和處方醫生——考慮到我們口服合成代謝藥物的現狀，他們確實看到口服甲狀旁腺激素（PTH）的治療效果逐漸提升，甚至不需要階梯式治療——就可以用於這類人群。

So that's -- so these are very large sort of untreated population that could benefit from an oral anabolic and where payers I think would be willing to really to cover the product. Does that answer the question?

所以——這些未經治療的人群可能受益於口服合成代謝藥物，而且我認為付費方也願意承擔該產品的費用。這回答了問題嗎？

I think I might just add to it and thank you, Kalpit for your support. We have collected all of this data in a micro way. And I think our plan is we'll disseminate portions of the study to analysts in the coming months. We're going through also as we finalize the Phase III strategy. But just to echo what Spiros said, because the potential for this drug is obviously oral and PTH is well validated, there is also quite a high level of enthusiasm from the clinical community of potentially cycling through or sequencing anabolic followed by antiresorptives and vice versa. And we've seen that in precedent trials, right? So that data has been collected both qualitatively and quantitatively from the study that we conducted.

我想補充一下，感謝Kalpit的支持。我們已經以微觀方式收集了所有這些數據。我們的計劃是在未來幾個月內將研究的部分內容分發給分析師。我們也在最終確定III期臨床策略的過程中進行研究。不過，為了呼應Spiros的說法，由於這種藥物顯然具有口服潛力，而且甲狀旁腺激素（PTH）也得到了充分驗證，臨床界對循環或順序使用合成代謝藥物，然後使用抗吸收藥物，反之亦然，也抱有很高的熱情。我們在之前的試驗中也看到過這種情況，對吧？所以，我們從研究中收集的資料既有定性的，也有定量的。

Okay. That's helpful. And then last quarter, you noted there was regional interest in developing EB613, particularly in Asia. Can you give us any updates here on the progress of these discussions? And are you aiming to have something locked in before you initiate the pivotal study for EB613?

好的。這很有幫助。上個季度，您提到一些地區對開發EB613很感興趣，尤其是在亞洲。您能否向我們介紹這些討論的進展？在啟動EB613的關鍵研究之前，您是否計劃確定一些事項？

Thanks, Kalpit. Yes, we are actively pursuing the deals both globally and also regionally as we've indicated before, and I mean our intention is to partner the asset globally. That would be our preferred path, and we really expect to be finishing something by the end of the year. But I mean given the profile that we have in our Phase II data, it's a very attractive asset and the once-a-day oral kind of formulation.

謝謝，Kalpit。是的，正如我們之前所說，我們正在積極尋求全球和區域層面的交易，我的意思是，我們的目標是在全球範圍內與該資產合作。這將是我們首選的途徑，我們確實希望在年底前完成一些合作。但考慮到我們II期臨床試驗的數據，這是一個非常有吸引力的資產，而且是每日一次的口服劑型。

Again, it fits really well into the globally -- the osteoporosis problem are globally. So our goal is to really generate deep, best collaboration that will commercialize the asset globally, and we're getting a lot of interest. We had already announced. Also we've retained the (inaudible) bank, Torreya that has been working with us very well and generating a lot of inbound interest on partnering the asset.

再說一次，它與全球——骨質疏鬆症問題——非常契合。因此，我們的目標是真正建立深入、最佳的合作，將這項資產在全球範圍內商業化，而且我們已經獲得了許多人的興趣。我們已經宣布了這一消息。此外，我們也保留了（聽不清楚）Torreya銀行，他們一直與我們合作得很好，並且對合作這項資產產生了濃厚的興趣。

(Operator Instructions) Our next questions come from the line of Nathan Weinstein with Aegis Capital.

（操作員指示）我們的下一個問題來自 Aegis Capital 的 Nathan Weinstein。

I'd like to just start by asking about the optimization of the oral delivery platform. Specifically, were there some attributes you could speak about that are being optimized? Or which features of the platform are most relevant to that process?

我想先問一下口服給藥平台的優化情況。具體來說，您能談談哪些屬性正在優化嗎？或是平台的哪些功能與該流程最相關？

Thanks for your question. Yes, so in general, the features that we're looking to optimize and it's captured in our new IP are really around the physical chemical (inaudible) of the target molecules and so being able to handle sort of different charges on the molecules and also different molecular weights. And so with all of that and always with the goal of really reducing the variability that you ultimately have to deal with oral delivery, and we've seen that our optimized platform, we're achieving not only higher bioavailability but also lower variability, and we're able to address more molecules with the new IP that we've generated.

感謝您的提問。是的，總的來說，我們希望優化的特性，也就是我們新IP所捕捉到的特性，實際上圍繞著目標分子的物理化學性質（聽不清楚），從而能夠處理分子上的不同電荷以及不同的分子量。因此，我們始終致力於降低口服給藥最終需要處理的差異性。我們已經看到，我們優化的平台不僅實現了更高的生物利用度，還降低了差異性，並且我們能夠利用我們產生的新IP來處理更多分子。

And then just one additional important aspect to our new -- the new IP that we filed is -- our new IP also includes some important excipients that are already approved by FDA. So from a regulatory standpoint, there's fewer regulatory hurdles to incorporating those in new formulations that we are working on and there was also -- our scientists back at the lab were very -- did a lot of work in screening different molecules and things that could fit into our platform and we felt that the developments and the progress we made was significant, and that's why we filed the whole set of new patent applications. And these also give us a whole new patent life -- fresh patent life.

我們新申請的智慧財產權還有一個重要面向是，它包含一些已經獲得FDA批准的重要輔料。因此，從監管角度來看，將這些輔料納入我們正在研發的新配方中，面臨的監管障礙更少。此外，我們實驗室的科學家也做了大量工作，篩選出適合我們平台的不同分子和物質。我們認為，我們所取得的進展意義重大，因此我們提交了一系列新的專利申請。這些申請也賦予了我們全新的專利壽命——全新的專利壽命。

Okay. Great. Makes sense. Maybe just one question here on EB613. Right now, obviously, looking at postmenopausal women at high risk of osteoporosis. But down the line, could it make sense to look at any other demographics?

好的。太好了。很有道理。也許EB613上只有一個問題。目前，顯然是在研究骨質疏鬆症風險較高的停經後女性。但從長遠來看，研究其他族群是否有意義？

Yes, I mean, obviously -- similar demographics that FORTEO has used in or other anabolics for males would be one other possibility, I mean -- and we could be expanding to additional populations. I could have -- Art, do you want to speak to the different populations that an oral anabolic could be sort of pointed towards.

是的，我的意思是，顯然——類似於福泰奧或其他男性合成代謝藥物所針對的人群，是另一種可能性——而且我們可能會擴展到更多人群。我可以……阿特，你想談談口服合成代謝藥物可能針對的不同族群嗎？

Sure. As Spiros pointed out, through the natural development cycle, first looks at the effectiveness of a drug in postmenopausal women with osteoporosis at high risk of fracture. That's the initial indication for injected teriparatide. Subsequently, the other target populations that would benefit from an anabolic are men with osteoporosis.

當然。正如斯皮羅斯指出的那樣，透過自然研發週期，首先要檢視藥物對患有骨質疏鬆症且骨折風險較高的停經後女性的有效性。這是注射特立帕肽的初始適應症。隨後，其他可能受益於合成代謝藥物的目標族群是患有骨質疏鬆症的男性。

Typically, that would be an idiopathic osteoporosis, not just low testosterone, but it could include that as well as people treated with anti-inflammatory steroids like prednisone, and that's usually called glucocorticoid-induced osteoporosis. So they would be subsequent target populations after an initial demonstration of efficacy in postmenopausal women with osteoporosis with high risk of facture.

通常情況下，這種情況指的是特發性骨質疏鬆症，而不僅僅是低睪固酮水平，但也可能包括特發性骨質疏鬆症，以及接受潑尼鬆等抗發炎類固醇治療的患者，這通常被稱為糖皮質激素誘發的骨質疏鬆症。因此，在對患有高骨折風險的停經後骨質疏鬆症女性進行初步療效驗證後，他們將成為後續目標族群。

(Operator Instructions) There are no further questions at this time. I would like to hand the call back over to Spiros Jamas for any closing comments.

（接線員指示）目前沒有其他問題了。我想把電話轉回給Spiros Jamas，請他做最後總結。

Thank you very much, everybody, for dialing in for our update today. Obviously, we are very excited with the addition of Miranda to the leadership team of Entera. As you can see, a lot is going on in the preparation for our Phase III for osteoporosis and expanding also our platform, and we look forward to further updates with you, and thank you for your support. Have a good day.

非常感謝各位撥通電話收聽我們今天的最新消息。米蘭達加入Entera領導團隊，我們當然非常高興。如各位所見，我們正在為骨質疏鬆症III期臨床試驗做準備，同時也擴展我們的平台。我們期待與您分享更多最新消息，也感謝您的支持。祝您擁有美好的一天。

Thank you. This does conclude today's teleconference. We appreciate your participation. You may disconnect your lines at this time. Enjoy the rest of your day.

謝謝。今天的電話會議到此結束。感謝您的參與。您可以掛斷電話了。祝您今天過得愉快。