PolyPid Ltd (PYPD) 2024 Q1 法說會逐字稿

Thank you all for participating in PolyPid first quarter 2024 earnings conference call. Joining me on the call today will be Dikla Czaczkes Akselbrad, Chief Executive Officer of PolyPid; Jonny Missulawin, PolyPid, Chief Financial Officer; and Ori Warshavsky, Chief Operating Officer US of PolyPid.

感謝大家參加 PolyPid 2024 年第一季財報電話會議。今天與我一起參加電話會議的是 PolyPid 執行長 Dikla Czaczkes Akselbrad； Jonny Missulawin，PolyPid，財務長；以及 PolyPid 美國營運長 Ori Warshavsky。

Earlier today, PolyPid released financial results for the three months ended March 31, 2024. A copy of the press release is available in the Investors section on the company's website, www.polypid.com.

今天早些時候，PolyPid 發布了截至 2024 年 3 月 31 日的三個月財務業績。新聞稿的副本可在公司網站 www.polypid.com 的投資者部分取得。

I'd like to remind you that on this call, management will make forward-looking statements within the meaning of the federal securities laws. For example, management is making forward-looking statements when it discusses the expected timing for a recruitment number of centers, top line results from the SHIELD II trial and the unblinded interim analysis. The planned new drug application submission for D-PLEX100, the strength of the company's intellectual property. The company's expected cash runway and the potential to receive additional funds if warrants are exercised.

我想提醒您，在這次電話會議上，管理層將做出聯邦證券法含義內的前瞻性陳述。例如，管理階層在討論中心招募數量的預期時間、SHIELD II 試驗的頂線結果以及非盲中期分析時，就做出了前瞻性陳述。此計畫提交的新藥申請為D-PLEX100，體現了公司的智慧財產權實力。該公司的預期現金跑道以及在行使認股權證時獲得額外資金的潛力。

Forward-looking statements are subject to numerous risks and uncertainties. Many of which are beyond our control, including the risks described from time-to-time in our SEC filings. Our results may differ materially from those projections. These statements involve material risks and uncertainties that could cause actual results or events to materially differ.

前瞻性陳述受到許多風險和不確定性的影響。其中許多是我們無法控制的，包括我們在 SEC 文件中不時描述的風險。我們的結果可能與這些預測有重大差異。這些陳述涉及重大風險和不確定性，可能導致實際結果或事件有重大差異。

Accordingly, you should not place undue reliance on these statements. I encourage you to review the company's filings with the Securities and Exchange Commission, including, without limitation, the company's Form 20-F, which identifies specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements.

因此，您不應過度依賴這些陳述。我鼓勵您查看該公司向美國證券交易委員會提交的文件，包括但不限於該公司的20-F 表格，該表格確定了可能導致實際結果或事件與前瞻性聲明中描述的結果或事件存在重大差異的具體因素。

PolyPid disclaims any intention or obligation, except as required by law to update or revise any financial projections or forward-looking statements, whether because of new information, future events or otherwise.

PolyPid 不承擔任何意圖或義務，除非法律要求更新或修改任何財務預測或前瞻性陳述，無論是因為新資訊、未來事件或其他原因。

This conference call contains time-sensitive information and speaks only as of the live broadcast today, May 8, 2024. With the completion of these prepared remarks, it's my pleasure to turn the call over to Dikla Czaczkes Akselbrad, CEO of PolyPid. Dikla?

本次電話會議包含時效性訊息，僅在今天（2024 年 5 月 8 日）直播時發言。在完成這些準備好的發言後，我很高興將電話轉給 PolyPid 執行長 Dikla Czaczkes Akselbrad。迪克拉？

Thank you, Brian. On behalf of our team at PolyPid, I would like to welcome everyone to our first quarter 2024 earnings conference call. We are excited about the substantial momentum throughout our business. Most importantly, as it relates to enrollment in our ongoing SHIELD II pivotal trail. So D-PLEX100 for the prevention of domino colorectal surgical site infection. Importantly, this clinical progress is being achieved with a recently fortified balance sheet.

謝謝你，布萊恩。我謹代表 PolyPid 團隊歡迎大家參加我們的 2024 年第一季財報電話會議。我們對整個業務的強勁勢頭感到興奮。最重要的是，因為它關係到我們正在進行的《神盾局 II》關鍵試驗的註冊。所以D-PLEX100用於預防多米諾結直腸手術部位感染。重要的是，這項臨床進展是透過最近強化的資產負債表來實現的。

Let's begin with the status of SHIELD II, I'm pleased to report today that the study has now enrolled more than 200 subjects and approximately 50 centers are currently open in multiple countries around the world, including the US. Germany, Italy, Ireland, Portugal, Hungary, and Israel. As a reminder, we intend to conduct an unblinded interim analysis once approximately 400 patients of the planned total of 600 subjects complete the 30 days follow-up, which is expected to occur in mid-2024.

讓我們從 SHIELD II 的現狀開始，我今天很高興地向大家報告，該研究現已招募了 200 多名受試者，目前在包括美國在內的全球多個國家開設了大約 50 個中心。德國、義大利、愛爾蘭、葡萄牙、匈牙利和以色列。提醒一下，一旦計劃的 600 名受試者中的約 400 名患者完成了 30 天的隨訪（預計在 2024 年中期進行），我們打算進行非盲中期分析。

Top-line results are anticipated in the second half of this year. Therefore, SHIELD II is now more than half enrolled for the interim analysis and more than one-third fully enrolled. Importantly, at the current status with indicate, enrollment is now progressing at a constant robust pace.

預計今年下半年將獲得頂線結果。因此，SHIELD II 目前有超過一半的人參與了中期分析，超過三分之一的人已完全參與。重要的是，從目前的情況來看，招生正在以持續強勁的速度進行。

With respect to the expected in recruitment rate. As we said on our last call, once society is fully up and running, which takes several weeks following being formally open, we anticipate approximately 1.5 patients being recruited into this trial, per centers, per month and we expect to have a total of approximately 60 centers opened in recruiting patients.

關於預期的招募率。正如我們在上次電話會議中所說，一旦社會完全啟動並運行（正式開放後需要幾週時間），我們預計每個中心每月大約招募1.5 名患者參與這項試驗，我們預計總共約有1.5名患者被招募到該試驗。

So at the peak of the enrollment period, we anticipate recruiting 90 patients per month similar to the enrollment rate we had in SHIELD I. With that said, having crossed the important 200 subject threshold, we thought we'd provide some color on several encouraging enrollment trends we are seeing, of note the median age male, female split and percentage of enrolled cancer patients, SHIELD II are similar to the patient population in the SHIELD I large incision pre-specified sample.

因此，在招募期的高峰期，我們預計每月招募90 名患者，與我們在《神盾局I》中的招募率類似。我們認為我們應該為幾個令人鼓舞的項目提供一些色彩我們看到的入組趨勢，值得注意的是，SHIELD II 的入組癌症患者的中位年齡男性、女性比例和百分比與SHIELD I 大切口預先指定樣本中的患者群體相似。

This is significant because we are thus far observing similar demographics in this more focused patient population in which we have already generated highly positive data in SHIELD I. This is yet another reason. We continue to strongly believe that SHIELD II is a de-risked Phase 3 trial, along with the fact that SHIELD II is not being conducted within the tight COVID-related restrictions that were in place during the pandemic and throughout the duration of SHIELD I.

這很重要，因為到目前為止，我們在這個更集中的患者群體中觀察到類似的人口統計數據，我們已經在 SHIELD I 中產生了高度積極的數據。我們仍然堅信 SHIELD II 是一項去風險的 3 期試驗，而且事實上 SHIELD II 並不是在大流行期間和整個 SHIELD I 期間實施的嚴格的新冠病毒相關限制範圍內進行的。

Of course, we are also leveraging key learnings from SHIELD I related to the science involved in this study. To this end, while we are targeting approximately 60 centers for SHIELD II around the same numbers, SHIELD I, we have firm knowledge of the best performing sites from SHIELD I. In terms of recruitment, patient monitoring, and good clinical practice.

當然，我們也利用了 SHIELD I 中與本研究涉及的科學相關的重要知識。為此，雖然我們的目標是約60 個SHIELD II 中心，與SHIELD I 的數量大致相同，但我們對SHIELD I 中表現最佳的中心有著深入的了解。 。

We believe this to be essential in the execution of SHIELD II, we have also enhanced our clinical operations team, another key step toward supporting the successful study. Moreover the Data Safety Monitoring Committee in charge of the review of cumulative safety data and study conduct for SHIELD II study has twice recommended to continue the study without modification. Meaning that no safety issues related to deflect 100 has been observed in SHIELD II toady.

我們相信這對於執行 SHIELD II 至關重要，我們也增強了我們的臨床操作團隊，這是支持成功研究的另一個關鍵步驟。此外，負責審查SHIELD II研究累積安全性資料和研究實施的資料安全監測委員會已兩次建議不加修改地繼續研究。這意味著目前在 SHIELD II 中尚未觀察到與 defle 100 相關的安全性問題。

Moving on to reiterate what we have said previously, we have a clear regulatory pathway for the potential NDA submission for the D-PLEX100 in the US. Last year, the FDA acknowledged not only the SHIELD I result may provide supportive evidence of the safety and efficacy of D-PLEX100 in patients with large surgical incision, but also confirm that if successful, SHIELD II is sufficient to support a potential NDA submission.

接下來重申我們之前所說的，我們對於在美國提交 D-PLEX100 的潛在 NDA 擁有明確的監管途徑。去年，FDA 承認 SHIELD I 結果不僅可以為 D-PLEX100 在大手術切口患者中的安全性和有效性提供支持證據，而且還確認如果成功，SHIELD II 足以支持潛在的 NDA 提交。

I'd like to take a moment to acknowledge and often overlooked key aspect of the compelling D-PLEX100 product profile, and that is its substantial intellectual property foundation. Specifically, we are fast approaching 175 granted and pending applications patents for the flex platform and its uses for the treatment of different indications.

我想花點時間承認 D-PLEX100 產品簡介引人注目且經常被忽視的關鍵方面，那就是其堅實的智慧財產權基礎。具體來說，我們正在快速接近 175 項已授予和正在申請的 Flex 平台專利及其用於治療不同適應症的用途。

And then those method of use patents are a significant number of patents with long-term protection for D-PLEX100 for the prevention of surgical site infections. For example, our D-PLEX100 SSI patents is expected to remain in effect until 2035 in more than 40 countries worldwide. This incredibly strong IP position only enhances the value of this promising late-stage product candidate for us.

然後這些使用方法專利是為D-PLEX100預防手術部位感染提供長期保護的大量專利。例如，我們的 D-PLEX100 SSI 專利預計將在全球 40 多個國家持續有效，直至 2035 年。這種令人難以置信的強大知識產權地位只會增強這個有前途的後期候選產品對我們的價值。

Shifting gears, we continue to in advance to form a strengthened financial position following our January 2024 private placement financing our PIPE for $16 million of gross profit. Importantly, our cash runway now extends into the fourth quarter of this year and beyond the anticipated timing of SHIELD II planned unblinded interim analysis. Moreover the company has the potential to secure an additional $19 million is the result of the unblinded interim analysis are positive and all warrants issued in the financing of exercise.

繼 2024 年 1 月私募融資為我們的 PIPE 提供 1,600 萬美元的毛利後，我們繼續提前加強財務狀況。重要的是，我們的現金跑道現在延伸到今年第四季度，超越了《神盾局 II》計畫的非盲中期分析的預期時間。此外，由於非盲中期分析的結果是正面的，並且所有認股權證都是在融資行使中發行的，因此該公司有可能獲得額外的 1,900 萬美元。

Which would fund qualities to the start of a planned rolling NDA submission for D-PLEX100. As a reminder, the PIPE syndicate was comprised of new and existing investors, including participation from US life sciences-focused investors, DAFNA Capital Management, and Rosalind Advisors.

這將為 D-PLEX100 計劃滾動 NDA 提交的開始提供資金。需要提醒的是，PIPE 財團由新投資者和現有投資者組成，其中包括專注於生命科學的美國投資者、DAFNA Capital Management 和 Rosalind Advisors 的參與。

Before I turn the call over to Jonny for his review of the financials, I'd like to let you all know that we have recently posted a newly revamped corporate presentation on our IR website. We would encourage all of you to take a look at your convenience. With that, it is my pleasure to now turn the call over to Jonny. Jonny?

在我將電話轉給喬尼（Jonny）進行財務審查之前，我想讓大家知道，我們最近在我們的投資者關係網站上發布了新修改的公司簡報。我們鼓勵大家在方便的情況下查看一下。現在，我很高興將電話轉給喬尼。喬尼？

Thank you, Dikla. As of March 31, 2024, the company had cash and short-term deposits of $14.5 million as compared to $5.3 million at the end of 2023. This includes the net proceeds of approximately $15 million generated from the PIPE financing closed in January 2024. We expect that our cash balance will be sufficient to fund operation into the fourth quarter 2024.

謝謝你，迪克拉。截至 2024 年 3 月 31 日，該公司的現金和短期存款為 1,450 萬美元，而 2023 年底為 530 萬美元。這包括 2024 年 1 月完成的 PIPE 融資產生的約 1,500 萬美元的淨收益。我們預計我們的現金餘額將足以為 2024 年第四季的營運提供資金。

Now let's turn to our income statement. Research and development expenses for the three months ended March 31, 2024, we're $5.1 million compared to $3.8 million in the same three month period of 2023. The increase in R&D expenses in the most recently completed quarter was driven by the ramp-up of the ongoing SHIELD II Phase 3 trial. Marketing and business development expenses for the three months ended March 31, 2024. We're still under $236,000, up to $385,000 during the prior year period.

現在讓我們來看看損益表。截至 2024 年 3 月 31 日的三個月研發費用為 510 萬美元，而 2023 年同期三個月的研發費用為 380 萬美元。最近完成的季度研發費用的增加是由正在進行的 SHIELD II 第 3 期試驗的加速推動的。截至 2024 年 3 月 31 日止三個月的行銷及業務開發費用。我們的收入仍低於 236,000 美元，而去年同期則高達 385,000 美元。

General and administrative expenses for the three months ended March 31, 2024, $1 million compared to $1.6 million recorded in the same three month period of 2023. This decrease reflects our ongoing cost containment efforts. For the three months ended March 31, 2024, the company had a net loss of $6.4 million as compared to $6.1 million in the first quarter of 2023.

截至 2024 年 3 月 31 日止三個月的一般及行政費用為 100 萬美元，而 2023 年同期三個月的一般及管理費用為 160 萬美元。這一下降反映了我們持續的成本控制努力。截至 2024 年 3 月 31 日的三個月，該公司淨虧損為 640 萬美元，而 2023 年第一季為 610 萬美元。

With that, we will now open the call to your questions. Operator?

現在，我們將開始回答您的問題。操作員？

(Operator Instructions) Roy Buchanan, JMP Securities.

（操作員指令）Roy Buchanan，JMP 證券。

Thanks for taking the questions. Appreciate all their comprehensive updates. A couple just quick ones on SHIELD II, I guess people can you just review in a little bit more detail, I guess the timeline for the NDA submission and the expected review now say at 505(b)(2), you have breakthrough designation this -- what can we expect as far as a time line? Then, what are the plans for Europe I'm assuming SHIELD II successful. You may be on mute or I may have dropped.

感謝您提出問題。感謝他們所有的全面更新。一些關於 SHIELD II 的快速內容，我想人們可以更詳細地回顧一下，我想 NDA 提交的時間表和預期的審查現在在 505(b)(2) 上說，你有突破性指定就時間線而言，我們可以期待什麼？那麼，我假設《神盾局 II》成功的話，歐洲的計畫是什麼。你可能處於靜音狀態，或者我可能已經掛斷了。

Now we are not on mute. Sorry, can you hear me?

現在我們沒有靜音。抱歉，你聽得到我說話嗎？

Yes.

是的。

Hi good morning. Thank you Roy. Thank you for the questions. So SHIELD II is expected to finalize the 400 patients for the interim analysis. This -- make this year with a readout for that and around the fall. And assuming we are stopping there or maybe I should say, assuming we are -- we will need to continue to the 600 patients, which is the minimum for the study design. It is another quarter for recruitment. So towards the end of the year, we expect to get that done as well.

早安.謝謝羅伊。謝謝你的提問。因此，SHIELD II 預計將最終確定 400 名患者進行中期分析。今年和秋季前後都會有一個讀數。假設我們就此停止，或者我應該說，假設我們是——我們將需要繼續研究 600 名患者，這是研究設計的最低限度。又是一個招募季度。因此，到今年年底，我們也希望能完成這項工作。

And the idea -- understanding that we have is that during 2025 as the first half of ['20] end of the first half of 2025, we should be submitting NDA, which means the towards the end of 2025, we will get the result. This assumes that we are continuing recruitment, and this is our assumption. If we decide to stop the recruitment then well -- let's leave it this way. So this is a field continuing to equipment up to the 600 patients. And this takes us into the end of 2025, for the NDA.

我們的想法是，在 2025 年上半年['20] 2025 年上半年結束時，我們應該提交 NDA，這意味著到 2025 年年底，我們將得到結果。這是假設我們正在繼續招募人員，這是我們的假設。如果我們決定停止招募，那麼好吧——就這樣吧。因此，這是一個持續為多達 600 名患者提供設備的領域。NDA 的簽署時間將在 2025 年底前。

With regards to Europe, we are looking at it as a parallel strategy. It takes a bit longer to get the approval in Europe, although we are entitled to the centralized procedure. So we can submit once and get an approval for all of Europe, which is very beneficial. We will be making a more, let's say, tactical decision as we get to the readout see whether we want to get before we submit to Europe to have the end of Phase 3 meeting with the FDA. But these are really a tactical. So our assumption is that Europe will shortly follow after US in terms of NDA.

對於歐洲，我們將其視為並行戰略。儘管我們有權採用集中程序，但在歐洲獲得批准需要更長的時間。所以我們可以提交一次並獲得整個歐洲的批准，這是非常有益的。當我們讀到結果時，我們將做出更多的戰術決定，看看我們是否想在向歐洲提交與 FDA 舉行第三階段會議結束之前做出決定。但這些確實是一種戰術。因此我們的假設是歐洲將很快在 NDA 方面緊隨美國之後。

Okay, great. And then just one on the sites, I guess, can you provide a bit more detail on the geographic breakdown of the current 55 and other countries are listed in the press release, but in others, predominantly in the US or elsewhere, Western Europe, et cetera. And then for the additional 10 sites where those expected to be added? Thanks.

好的，太好了。然後，我想，您能否提供有關當前55 個國家/地區的地理細分的更多詳細信息，以及新聞稿中列出的其他國家/地區，但在其他國家/地區，主要是在美國或其他地方，西歐，等等。那麼另外 10 個站點預計會加入哪裡呢？謝謝。

Sure. So we actually related a little bit to that in the press release listing the -- list the countries that are examples of countries that have participated. We listed US, Germany, Italy, Ireland, Portugal, Hungary, and Israel. We have some additional countries, Eastern European countries that are also being added. Overall, I would say that it is about -- between and in the European countries around between three to five centers per country in the US we have a bit more. And that's about that it's quite spread similar many countries that were in SHIELD I or also in SHIELD II. We didn't have that much Western Europe in SHIELD I, we have a little bit more of Western Europe now, which we see as a good thing because we see that the data is more clean and repeats itself.

當然。因此，我們實際上與新聞稿中的一些內容相關，列出了參與國家的範例。我們列出了美國、德國、義大利、愛爾蘭、葡萄牙、匈牙利和以色列。我們還有一些其他國家，東歐國家也正在增加中。總的來說，我想說的是——在歐洲國家之間，在美國每個國家大約有三到五個中心，我們有更多的中心。這就是說，它在《神盾局 I》或《神盾局 II》中的許多國家/地區都非常普及。我們在《神盾局 I》中沒有那麼多西歐，現在我們有更多的西歐，我們認為這是一件好事，因為我們看到數據更乾淨並且可以重複。

Okay. That's helpful. Thank you. And then maybe one last one, if I can. Just I guess, assuming SHIELD II successful, how soon do you think you can pivot or not pivot advance a pipeline of OncoPLEX, I guess in the waiting, what are the plans? How fast can you get that going? Thank you.

好的。這很有幫助。謝謝。如果可以的話，也許還有最後一件事。只是我猜，假設 SHIELD II 成功，您認為多久可以轉向或不轉向推進 OncoPLEX 的管道，我想在等待中，有什麼計劃？你能多快做到這一點？謝謝。

So this is something that we are actually putting a lot of effort now into. So obviously, our top priority right now is the D-PLEX100. But as we previously said, we are looking into the pipeline. The second in line priorities is the oncology program, the OncoPLEX and which remains a priority for us. And if you remember, we had a successful [pre-IND] meeting with the US FDA supporting the Phase 1,2 clinical trial. So this our first priority, but we are also looking on potential broadening of that and more strategic pipeline prioritization looking also in some additional direction in order to be prepared with this for the time of the top line, we want to make sure that once we are past this very important milestone of Phase 3 in SHIELD I -- sorry SHIELD II in D-PLEX100. We are ready for expansion of the pipeline. So I think after the top line, we will also have some news to share there. This is something we are looking at very in-depth.

所以這是我們現在實際上正在投入大量精力的事情。顯然，我們現在的首要任務是 D-PLEX100。但正如我們之前所說，我們正在研究管道。第二優先事項是腫瘤學課程 OncoPLEX，它仍然是我們的優先事項。如果您還記得的話，我們與美國 FDA 成功舉行了 [IND 前] 會議，支持 1,2 期臨床試驗。因此，這是我們的首要任務，但我們也在尋找潛在的擴大範圍和更具戰略意義的管道優先順序，同時也在尋找一些額外的方向，以便為頂線時間做好準備，我們希望確保一旦我們已經過了 SHIELD I 第 3 階段這一非常重要的里程碑 - 抱歉，D-PLEX100 中的 SHIELD II。我們已準備好擴大管道。所以我認為在頂線之後，我們還會有一些新聞可以分享。這是我們正在非常深入研究的事情。

Okay. Thank you.

好的。謝謝。

Thank you. There seems to be no further questions. I would like to hand back for closing remarks.

謝謝。似乎沒有更多的問題了。我想交出結束語。

Thank you for joining PolyPid first quarter 2024 earnings conference call. We remain highly confident in our long-term prospects, especially the potential of our promising late-stage product candidate, D-PLEX100. As always, we are grateful to our team members, shareholder, and all external partners for their commitment through our mission and support in continuing to advance toward our goal of bringing D-PLEX100 to health care providers and patients as quickly as possible. We look forward to speaking with you again on our next conference call.

感謝您參加 PolyPid 2024 年第一季財報電話會議。我們對我們的長期前景仍然充滿信心，尤其是我們有前途的後期候選產品 D-PLEX100 的潛力。一如既往，我們感謝我們的團隊成員、股東和所有外部合作夥伴透過我們的使命所做的承諾和支持，繼續推進我們的目標，即盡快將 D-PLEX100 帶給醫療保健提供者和患者。我們期待在下次電話會議上再次與您交談。