PolyPid Ltd (PYPD) 2024 Q4 法說會逐字稿

Greetings and welcome to the PolyPid Fourth Quarter 2024 Conference Call. At this time, participants are in listen-only mode.

問候並歡迎參加 PolyPid 2024 年第四季電話會議。此時，參與者處於只聽模式。

As a reminder, this call is recorded and I would now like to introduce your host for today's conference, Brian Ritchie from LifeSci Advisors Mr. Ritchie, you may begin.

提醒一下，這次通話已被錄音，現在我想介紹今天會議的主持人，來自 LifeSci Advisors 的 Brian Ritchie。 Ritchie 先生，您可以開始。

Thank you all for participating in PolyPid Fourth Quarter and Full Year 2024 Earnings Conference Call. Joining me on the call today will be Dikla Czaczkes Akselbrad, Chief Executive Officer of PolyPid, Jonny Missulawin, PolyPid's Chief Financial Officer, and Ori Warshavsky, Chief Operating Officer, US of PolyPid.

感謝大家參加 PolyPid 2024 年第四季和全年財報電話會議。今天與我一起參加電話會議的還有 PolyPid 執行長 Dikla Czaczkes Akselbrad、PolyPid 財務長 Jonny Missulawin 和 PolyPid 美國營運長 Ori Warshavsky。

Earlier today, PolyPid released its financial results for the three months and 12 months ended December 31, 2024. A copy of the press release is available in the investors section on the company's website www.Polype.com.

今天早些時候，PolyPid 公佈了截至 2024 年 12 月 31 日的三個月和 12 個月的財務業績。新聞稿副本可在本公司網站 www.Polype.com 的投資者專區查閱。

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 potential efficacy of D-PLEX100 and the probability of success of the trial that the gross proceeds from the company's recent financing extend the company's cash runway into the third quarter of 2025 beyond the expected top line results from Shield 2.

我想提醒您，在本次電話會議上，管理層將根據聯邦證券法做出前瞻性陳述。例如，管理層在討論 D-PLEX100 的潛在功效和試驗成功的可能性時做出了前瞻性陳述，即公司近期融資的總收益將使公司的現金流延長至 2025 年第三季度，超出 Shield 2 的預期營收業績。

The expected timing for completion of enrollment of the Shield 2 trial, the expected timing for top line results from the Shield 2 trial, potential NDA submission, accelerating preparations for regulatory submissions, and pre-launch activities. Potential clinical benefits of D-PLEX100.

Shield 2 試驗註冊完成的預期時間、Shield 2 試驗頂線結果的預期時間、潛在的 NDA 提交、加速監管提交的準備工作以及發布前活動。D-PLEX100 的潛在臨床效益。

Potential market size for D-PLEX100 in the United States, potential partnership opportunities, potential benefits from the collaboration with immunogenesis that the exercise of the warrants from the pipe in full would result in an additional $27 million in gross proceeds, that proceeds of all warrants issued in the pipe, if exercised, would provide the company with capital beyond NDA approval.

D-PLEX100 在美國的潛在市場規模、潛在的合作機會、與免疫發生合作的潛在利益，如果全面行使該管道的認股權證，將產生額外的 2700 萬美元的總收益，如果行使該管道發行的所有認股權證的收益，將為公司提供超出 NDA 批准的資本。

Opportunities for the use of D-PLEX100 in additional procedures and the company's long-term prospects. 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.

D-PLEX100 在附加程式中的使用機會以及公司的長期前景。前瞻性陳述受多種風險和不確定性的影響，其中許多是我們無法控制的，包括我們向美國證券交易委員會提交的文件中不時描述的風險。

The company's results may differ materially from those projections. These statements involve material risks and uncertainties that could cause actual results or events to materially differ. Accordingly, you should not place undue reliance on these statements.

該公司的業績可能與這些預測有重大差異。這些聲明涉及重大風險和不確定性，可能導致實際結果或事件產生重大差異。因此，您不應過度依賴這些聲明。

I encourage you to review the company's filings with the Securities and Exchange Commission, including without limitation, the company's annual report on Form 20F, which identifies specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements.

我鼓勵您查看公司向美國證券交易委員會提交的文件，包括但不限於公司 20F 表年度報告，其中列出了可能導致實際結果或事件與前瞻性陳述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. This conference call contains time sensitive information and speaks only as of the live broadcast today, February 12, 2025.

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，無論是由於新資訊、未來事件或其他原因。本次電話會議包含時間敏感訊息，僅代表截至今天（2025 年 2 月 12 日）現場直播的內容。

With the completion of those prepared remarks, it is my pleasure to turn the call over to Dikla Czaczkes Akselbrad, CEO of PolyPid.

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。

Dikla?

迪克拉？

Thank you, Brian. On behalf of our team at PolyPid, I would like to welcome everyone to our fourth quarter and full year 2024 earnings conference call.

謝謝你，布萊恩。我謹代表 PolyPid 團隊歡迎大家參加我們的 2024 年第四季和全年財報電話會議。

We are very pleased with the recent critical advancement in our business, most notably as it relates to the recommendation by the Independent Data Safety Monitoring Board or DSM, to conclude the Shield 2 phase 3 trial assessing the efficacy of D-PLEX100 for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery upon enrollment of 800 patients.

我們對近期業務取得的關鍵進展感到非常高興，最值得注意的是，它與獨立資料安全監測委員會 (DSM) 的建議有關，即完成 Shield 2 第 3 階段試驗，該試驗在招募 800 名患者後評估 D-PLEX100 在預防接受腹部結直腸手術的患者手術部位感染方面的功效。

Which is the lowest sample size reassessment stopped after the minimum planned number of patients.

這是在達到最低計劃患者數後停止的最低樣本量重新評估。

We viewed the DSMB's recommendation to conclude Shield 2 upon the enrollment of 800 patients as a favorable outcome, as it is suggestive of positive efficacy signals from D-PLEX100. As a reminder, the data generated from Shield 2 to date remain fully blinded to PolyPid and others outside of the DSMB until top line results are available.

我們認為 DSMB 建議在招募 800 名患者後結束 Shield 2 是有利的結果，因為它暗示了 D-PLEX100 的積極療效訊號。提醒一下，迄今為止，Shield 2 產生的資料對於 PolyPid 和 DSMB 之外的其他機構來說仍然是完全隱藏的，直到獲得頂線結果為止。

As previously reported, we concurrently announced that we entered into a securities purchase agreement for a private placement financing led by existing institutional shareholders for $14.5 million in gross proceeds.

如前所述，我們同時宣布已達成一項證券購買協議，以現有機構股東為首的私募融資，總收益為 1,450 萬美元。

The gross proceeds from the financing extend PolyPid's cash runway into the third quarter of 2025 beyond the expected topline result from Shield 2.

此次融資的總收益將使 PolyPid 的現金流量延長至 2025 年第三季度，超出 Shield 2 的預期營收業績。

More on this transaction in a moment. First, however, some further discussions around the DSMB recommendation and our planned next steps. Most importantly, the sample size reassessment is an opportunity to ensure the study has sufficient power to conclusively confirm D-PLEX100's treatment benefit, and we believe this increases the trial's overall probability of success.

稍後我們將詳細介紹此交易。不過，首先，我們要就 DSMB 建議和我們計劃的後續步驟進行進一步討論。最重要的是，樣本量重新評估是一個機會，可以確保研究具有足夠的能力來最終證實 D-PLEX100 的治療益處，我們相信這會增加試驗的整體成功機率。

The study has enrolled over 700 patients to date, and at the current enrollment rate of roughly 20 patients per week, we expect to complete enrollment of Shield 2 next month. We anticipate reporting top line result in the second quarter of 2025.

迄今為止，該研究已招募了 700 多名患者，以目前每週約 20 名患者的招募速度，我們預計下個月將完成 Shield 2 的招募。我們預計將在 2025 年第二季報告營收業績。

Upon potential positive phase 3 data, PolyPid expects to submit a new drug application or NDA with the advantages of fast track and breakthrough therapy designations.

一旦獲得潛在的積極 3 期數據，PolyPid 預計將提交具有快速通道和突破性療法認定優勢的新藥申請或 NDA。

We are thrilled to welcome Mr. Yitzchak Jacobovitz to the company's Board of Directors. Mr. Jacobovitz is a partner and a lead healthcare analyst at AIGH Capital Management and affiliates, the Lead Investor from the December financing.

我們非常高興地歡迎 Yitzchak Jacobovitz 先生加入公司董事會。Jacobovitz 先生是 AIGH Capital Management 及其附屬公司的合夥人兼首席醫療保健分析師，也是 12 月融資的領投者。

He is also a Board Member at Myomo Inc. Mr. Jacobovitz earned his MBA from Johns Hopkins University and is a Chartered Financial Analyst.

他也是 Myomo Inc. 的董事會成員。 Jacoboitz 先生擁有約翰霍普金斯大學的 MBA 學位，是一名特許金融分析師。

We look forward to completing the trial and are focused on accelerating preparations for our regulatory submissions, pre-launch activities, and expediting partnership discussions in and outside of the United States.

我們期待完成試驗，並致力於加快監管提交的準備工作、上市前活動以及加快美國境內外的合作討論。

I will now turn the call over to Ori to discuss market potential, partnering efforts and our recently announced collaboration. Ori.

現在我將把電話轉給 Ori，討論市場潛力、合作努力以及我們最近宣布的合作。奧裡。

Thank you, Dikla.

謝謝你，迪克拉。

I would like to provide some additional color on our market potential for D-PLEX100 and our related partnering discussions.

我想就 D-PLEX100 的市場潛力以及相關合作討論提供一些額外的資訊。

We believe the total addressable market for D-PLEX100 in the US is just over 12 million surgeries per year based on accurate data, the leading industry source on procedure and prescription data. There are approximately 4.4 million abdominal soft tissue surgeries annually, both open and minimally invasive procedures, principally comprised of a hernia repair, appendectomies, and colorectal surgeries.

根據準確的數據（領先的行業手術和處方數據來源），我們認為 D-PLEX100 在美國的整體潛在市場每年略高於 1200 萬例手術。每年約有 440 萬例腹部軟組織手術，包括開放性手術和微創手術，主要包括疝氣修補術、闌尾切除術和結直腸手術。

We also believe that there is an opportunity for the use of D-PLEX100 in an additional 2.1 million abdominal procedures in Gynecology and Neurology, including Hysterectomy and related procedures.

我們也相信，D-PLEX100 有機會在婦科和神經科的另外 210 萬例腹部手術中使用，包括子宮切除術和相關手術。

Other D-PLEX100 potentially relevant surgeries, which either have high SSI rates or have high clinical and financial costs if an infection develops, includes (striotomies) and joint replacement.

其他 D-PLEX100 潛在相關手術包括紋狀體切開術和關節置換術，這些手術要么具有較高的 SSI 發生率，要么在發生感染時具有較高的臨床和財務成本。

According to the CDC, SSIs are a substantial cause of mobility, prolonged hospitalization, and mortality. It is reported that SSI accounts for 20% of all hospital-acquired infections and is associated with a two to 11-fold increase in the risk of mortality, with 75% of SSI associated deaths directly attributable to the SSI.

據疾病預防控制中心稱，手術部位感染是導致行動不便、長期住院和死亡的重要原因。據報道，SSI 佔所有醫院內感染的 20%，並使死亡風險增加 2 至 11 倍，其中 75% 的 SSI 相關死亡直接歸因於 SSI。

SSI is the most costly hospital-acquired infection type with an estimated annual cost of $3.3 billion and extends hospital length of stay by 9.7 days, with cost of hospitalization increased by more than $20,000 per admission.

SSI 是最昂貴的醫院內感染類型，估計每年花費 33 億美元，並延長住院時間 9.7 天，每次入院的住院費用增加 20,000 多美元。

A CDC report published in November 2024 tracking hospital-acquired infections in over 3,000 hospitals showed an increase of 3% in SSIs across all surgeries in 2023 as compared to 2022. The outcome of this report confirms what we have seen in our own clinical data, a reduction in SSIs in the COVID years and subsequently an increase in SSI post-COVID.

美國疾病管制與預防中心 (CDC) 於 2024 年 11 月發布了一份報告，追蹤了 3,000 多家醫院的醫院內感染情況，報告顯示，與 2022 年相比，2023 年所有手術的 SSI 增加了 3%。報告的結果證實了我們在自己的臨床數據中看到的情況，即 COVID 時期 SSI 減少，隨後 COVID 之後 SSI 增加。

Collectively, this market data reflects a large and broad unmet need and commercial opportunity for D-PLEX100 in the US without even considering the more substantial global market. If approved, D-PLEX100 could potentially significantly transform the surgical landscape where post-operative SSIs remain a costly program.

總的來說，這些市場數據反映了美國對 D-PLEX100 的巨大而廣泛的未滿足需求和商業機會，甚至沒有考慮更龐大的全球市場。如果獲得批准，D-PLEX100 可能會顯著改變外科手術格局，目前術後 SSI 仍然是一項昂貴的計畫。

Turning to our partnering efforts, we remain in active discussions with several potential partners for the commercialization of D-PLEX100 in different regions, with the US being our priority after the exclusive licensing agreement already signed with Advanced Pharma for Europe.

談到我們的合作努力，我們仍在與幾個潛在合作夥伴積極討論在不同地區商業化 D-PLEX100，在與 Advanced Pharma 簽署歐洲獨家許可協議後，美國成為我們的優先考慮領域。

Following the recent interim results and the SMP recommendations, we have seen an uptick in discussions with potential partners and just as important, a positive shift in the tone of those conversations. We are also focused on partnering efforts centered on our proprietary drug delivery technology that enables controlled and prolonged (intratumal) drug delivery.

根據最近的中期業績和 SMP 建議，我們看到與潛在合作夥伴的討論有所增加，同樣重要的是，這些對話的基調發生了積極轉變。我們也致力於以我們專有的藥物輸送技術為中心的合作，該技術可實現可控和延長的（腫瘤內）藥物傳輸。

As such, last December, PolyPid and (immunogenesis), a Houston-based clinical stage biotechnology company, announced a research and development collaboration focused on combining PolyPid technology with (immunogenesis), potent stimulator of interference genes, or sting, agonist drug candidate to enhance treatment for solid tumors.

因此，去年 12 月，PolyPid 和總部位於休士頓的臨床階段生物技術公司 (immunogenic) 宣布了一項研發合作，重點是將 PolyPid 技術與 (immunogenic)（一種幹擾基因的強效刺激劑或激動劑候選藥物）相結合，以增強對實體瘤的治療。

Teen agonists are very potent, but have a short half-life in the tumor microenvironment, limiting their ability to shrink tumors when administered alone. This collaboration aims to take advantage of prolonged drug release enabled by our delivery technology, with the goal of enhanced sting anti-tumor activity.

青少年激動劑非常有效，但在腫瘤微環境中的半衰期較短，限制了它們單獨使用時縮小腫瘤的能力。此次合作旨在利用我們的輸送技術實現藥物的延長釋放，以增強刺痛抗腫瘤活性。

The strategy could potentially overcome existing challenges of uneven distribution and limited exposure in dense tumor tissues. While enhancing immune cell infiltration and activation within the tumor microenvironment. We believe this collaboration could create a cutting-edge approach to immune oncology and will continue to explore additional opportunities to bring value to innovative partnerships.

此策略可能克服緻密腫瘤組織中分佈不均勻和暴露有限的現有挑戰。同時增強腫瘤微環境內的免疫細胞浸潤活化。我們相信，此次合作可以創造一種尖端的免疫腫瘤學方法，並將繼續探索更多機會為創新夥伴關係帶來價值。

With that, it is my pleasure to now turn the call over to Johnny to review the financials. Johnny.

好了，我現在很高興將電話轉給約翰尼來審查財務狀況。約翰尼。

Thank you, Ori. We are thrilled to advance each of our initiatives from a significantly enhanced financial position. As of December 31, 2024, the company had cash and cash equivalent of $15.6 million.

謝謝你，Ori。我們很高興能夠在財務狀況顯著改善的情況下推進我們的每一項舉措。截至 2024 年 12 月 31 日，該公司擁有現金和現金等價物 1,560 萬美元。

We expect that our current cash balance will be sufficient to fund operations into the third quarter of 2025. Now, let me briefly review the highlights of the private placement we recently entered into with existing events investors for $14.5 million in gross proceeds.

我們預計目前的現金餘額足以支持到 2025 年第三季的營運。現在，讓我簡要回顧一下我們最近與現有活動投資者達成的私募的亮點，總收益為 1,450 萬美元。

The investors also received warrants which will expire upon the earlier of nine months from the date of issuance and 10 trading days following our announcement of top line results. Exercise of the warrants in full would result in an additional $27 million in gross proceeds.

投資者還獲得了認股權證，該認股權證將在發行之日起九個月或我們公佈營收結果後的十個交易日（以較早者為準）到期。全部行使認股權證將帶來額外 2700 萬美元的總收益。

Proceeds of all warrants issued in this transaction, if exercised, would provide the company with capital beyond NDA approval. We believe that the participation in this transaction from a leading group of life sciences focused existing investors is indicative of the substantial transformative potential of D-PLEX100.

如果行使此交易中發行的所有認股權證的收益，將為公司提供超出 NDA 批准的資本。我們相信，來自專注於生命科學的領先現有投資者群體的參與此次交易表明了 D-PLEX100 的巨大變革潛力。

We are grateful for this continued demonstration of confidence and support.

我們感謝大家持續的信任與支持。

Now let's turn to our income statements.

現在讓我們來看看損益表。

Research and development expenses for the three months ended December 31, 2024 for $7 million compared to $4.6 million in the same three month period of 2023.

截至 2024 年 12 月 31 日的三個月的研發費用為 700 萬美元，而 2023 年同期為 460 萬美元。

R&D expenses in the most recently completed fourth quarter were driven by the ramp up of the ongoing Shield 2 phase 3 trial.

最近完成的第四季度的研發費用受到正在進行的 Shield 2 第 3 階段試驗的推動。

For the full year ended December 31, 2024 and 2023, R&D expenses were $22.8 million and $16.1 million respectively. Marketing and business development expenses for the fourth quarter of 2024 were $0.2 million compared to $0.2 million during the prior year period.

截至 2024 年 12 月 31 日及 2023 年 12 月 31 日的全年，研發費用分別為 2,280 萬美元及 1,610 萬美元。2024 年第四季的行銷和業務開發費用為 20 萬美元，而去年同期為 20 萬美元。

General and administrative expenses for the fourth quarter of 2024 were $1 million compared to $1.2 million recorded in the same three month period of 2023. For the fourth quarter of 2024, the company had a net loss of $8.5 million as compared to $6.4 million in the fourth quarter of 2023.

2024 年第四季的一般及行政費用為 100 萬美元，而 2023 年同期為 120 萬美元。2024 年第四季，該公司淨虧損 850 萬美元，而 2023 年第四季淨虧損 640 萬美元。

For calendar year 2024, the company had a net loss of $29 million compared to a net loss of $23.9 million in the full year 2023.

2024 日曆年，該公司淨虧損 2,900 萬美元，而 2023 年全年淨虧損 2,390 萬美元。

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

接線員，我們現在將開始回答您的問題。

Thank you. To ask a question.

謝謝。提出一個問題。

(Operator Instructions)

（操作員指示）

We will now take our first question.

我們現在來回答第一個問題。

From the line of Roy Buchanan from JMP, please go ahead.

請 JMP 的 Roy Buchanan 繼續發言。

Hey, thanks for taking the question. I guess just just one to start. I get, can you just help us think about your expectations for the label, assuming the data is positive, which we expect, and then just, I know Ori went over the TAM in pretty good detail, but just how you're expecting to target those different segments and your commercialization readiness and plans.

嘿，謝謝你回答這個問題。我想這只是一個開始。我明白，您能否幫助我們思考一下您對標籤的期望，假設數據是積極的，這也是我們所期望的，然後，我知道 Ori 非常詳細地介紹了 TAM，但您期望如何針對這些不同的細分市場以及您的商業化準備和計劃。

Thanks.

謝謝。

Good morning, Roy.

早安，羅伊。

Thank you. So we, our expectation is that as the first stage we will have both in the US and in Europe a labeling that is in the area of the abdominal surgery.

謝謝。因此，我們的期望是，作為第一階段，我們將在美國和歐洲獲得腹部外科領域的標籤。

This is how we see ourselves launching the product with a general abdominal. It could be a more focused one on, let's say, let's call it large incision or things like that, but this is where we stand in terms of our expectation, and we have a very detailed plan on how to expand that.

這就是我們如何看待自己推出具有普遍意義的產品。它可能更有針對性，比如說，我們稱之為大切口或類似的東西，但這就是我們的期望，我們有一個非常詳細的計劃來擴展它。

So that's with the label you were asking about the commercialization and marketing effort.

這就是您所詢問的有關商業化和行銷努力的標籤。

Yes, yeah

是的，是的

Oh, you want to take the second part?

哦，你想拍第二部嗎？

Yes, I, I'll take it. Hey Roy. So, two kind of two parts to this to the sensor. I went over the numbers. Half like we said about half of the of the total addressable market is related to soft tissue, abdominal, then gynecology, urology, some of the, C-section can go in there breast reconstruction can go in there. I think the I think the point is from our perspective is really finding a strong partner.

是的，我，我會接受的。嘿，羅伊。因此，感測器有兩種部分。我查看了這些數字。正如我們所說，整個可尋址市場的大約一半與軟組織、腹部有關，然後是婦科、泌尿科，其中一些，剖腹產可以進行，乳房重建可以進行。我認為從我們的角度來看，關鍵在於找到一個強大的合作夥伴。

That can can drive these, have these conversations with both with surgeons, with the pharmacy directors, with the infectious disease specialist. I think it's we under we understand that selling into into the hospital is. It's a, is, it's a complex task and we need the right partner for that and this is really top of mind at least, from, for me is and for all of us is to find the right partner for that that can really have these conversations.

這可以推動這些，與外科醫生、藥房主任、傳染病專家進行這些對話。我認為，我們理解銷售到醫院是合理的。這是一項複雜的任務，我們需要合適的合作夥伴，至少對我來說，對我們所有人來說，這都是最重要的事情，就是找到一個能夠真正進行這些對話的合適的合作夥伴。

So but it'll be gradually right it's not day one. All these 12 million surgeries or even just the abdominal we're starting our foot in the door in the colorectal and then expanding just like the I mentioned on the label gradually expanding.

所以，但它會逐漸正確，這不是第一天。所有這些 1200 萬例手術，甚至只是腹部手術，我們都是從結直腸手術開始的，然後像我在標籤上提到的那樣逐漸擴大。

I can tell you (anecdotally) from my conversations with surgeons what I heard is once the product is on formulary. They understand that if an incision is made in the abdominal for a colorectal resection or an incision is made for appendectomy, it's the same incision in a way, broadly speaking and once it's on formulary they will use it more broadly and get the experience with the product.

我可以（透過軼事）告訴你，根據我與外科醫生的談話，我聽到的是一旦產品進入處方集。他們明白，如果為了進行結腸直腸切除術而在腹部開一個切口，或者為了進行闌尾切除術而在腹部開一個切口，從廣義上講，它們在某種程度上是相同的切口，一旦它被列入處方，他們就會更廣泛地使用它並獲得產品使用經驗。

Okay, perfect.

好的，完美。

Thank you. I'll jump back into you.

謝謝。我會跳回你身邊。

Thank you. We will now take the next question.

謝謝。我們現在來回答下一個問題。

From the line of Chase Knickerbocker from Craig-Hallum, please go ahead.

請代表 Craig-Hallum 的 Chase Knickerbocker 發言。

Good morning, everyone. Thanks for the question. So I guess just to start, can you give us a general idea of kind of how similar these kind of subsequent 270 patients, from a baseline kind of characteristic perspective that, like geographies of the facilities that are enrolling these patients, etc. When you compare it to the 430 that informed the interim analysis is trying to get a sense of kind of the how similar these patients have been to the kind of interim analysis patient from a baseline perspective. Thanks.

大家早安。謝謝你的提問。所以我想首先，您能否從基線特徵的角度，大致介紹一下這 270 名後續患者的相似程度，例如，招募這些患者的設施的地理位置等。當您將其與中期分析的 430 名患者進行比較時，請嘗試從基線角度了解這些患者與中期分析患者的相似程度。謝謝。

Sure, thank you for the question. So it is in line with our expectations. We are blinded, so we don't really know how the infection rate is divided between the two arms, but we don't see anything that is alarming us in the sense that it is not in line with our expectation or what we've seen up until now in the longer recruitment and in the interim.

當然，謝謝你的提問。所以這符合我們的預期。由於我們是盲測的，所以我們並不真正知道兩組之間的感染率是如何分佈的，但我們沒有發現任何令我們擔憂的情況，即它不符合我們的預期，或者與我們迄今為止在長期招募和中期所看到的情況不符。

Again, also the interim was blinded, but as a as an overall.

再一次，雖然臨時性措施也是盲目的，但總體而言。

And in terms of geography, again, it's very similar since all the centers were open and recruiting at the time that we recruited the patient for the interim data, so we don't have new geographies or new centers. So this is also continuing. We are very pleased with the rate of the recruitment. And I expect that the within a few weeks we will be announcing last patient.

就地理位置而言，情況非常相似，因為當我們為中期數據招募患者時，所有中心都已開放並正在招募，所以我們沒有新的地理位置或新的中心。所以這還在繼續。我們對招募率感到非常滿意。我預計幾週內我們將宣布最後一位病人。

Great, and so yeah, I'm at those enrollment dynamics. So, you kind of return to that, call it, 80 patients per month, and then just seconds, after the kind of Christmas time slowdown and holiday time slowdown, and then just second on the readout timing. So, just so we kind of understand on the primary obviously 30 day follow up and then kind of post that we should think a month or two for, kind of day to clean up and. And all the normal things, so, fairly confident if you, enroll, finish enrollment next month that we're talking to, call it late to kind of readout on the top one.

太好了，是的，我了解這些招生動態。因此，您回到那個狀態，稱之為每月 80 名患者，然後只需幾秒鐘，在聖誕節和假期放緩之後，讀出時間只需幾秒鐘。因此，我們大概可以理解，在主要的 30 天跟進之後，我們應該考慮用一兩個月的時間來清理。以及所有正常的事情，因此，如果您有信心，下個月報名，完成我們正在討論的報名，那麼現在就可以晚點讀到上面的內容。

Thank you.

謝謝。

Yes, very confident. I would expect that we will be announcing in March. Hopefully the beginning of the first half of March, last patient in, and from that point, exactly as you said, two months for follow-up or one month for follow up for the primary and some time for the cleaning of the data. So a quarter from the time that we announce the last patient in, this is around the time that we will be announcing top line results.

是的，非常有信心。我預計我們將在三月宣布這一消息。希望在三月上半月初，最後一名患者入院，從那時起，正如您所說，需要兩個月的隨訪時間或一個月的隨訪時間進行主要隨訪，並需要一些時間來清理數據。因此，從我們宣布最後一位患者入院到現在大約四分之一的時間，我們就會宣布最重要的結果。

Great thanks.

非常感謝。

Thank you.

謝謝。

Thank you. We will now take the next question.

謝謝。我們現在來回答下一個問題。

From the line of Raghuram Selvaraju from H.C. Wainwright & CO. Please go ahead.

源自 H.C. 的 Raghuram Selvaraju 家族。溫賴特公司請繼續。

Thanks very much for taking my questions. Firstly, on the commercial front, I was wondering if you could give us some more insight into what you expect the properties of an ideal commercial partner to be, specifically in the US for D-PLEX100. And also, if you could give us some sense of, if we think about the hypothetical ideal scenario, how the responsibilities might be divided between yourselves and a potential commercial partner, would you expect to have any involvement in sales and promotional activities?

非常感謝您回答我的問題。首先，在商業方面，我想知道您是否可以向我們提供一些更深入的見解，了解您期望的理想商業合作夥伴的特性，特別是在美國對於 D-PLEX100 的要求。另外，如果您能為我們講一下，如果我們考慮假設的理想情況，您和潛在的商業夥伴之間如何劃分責任，您是否希望參與銷售和促銷活動？

If so, In what specific sales and promotional activities would those be targeted to a specific sub-population of prescribers, for example, and also if you could elaborate on the extent to which you expect to have sole control over the manufacturing and supply of D-PLEX100 for the US market.

如果是的話，那麼在哪些特定的銷售和促銷活動中，這些活動將針對特定的處方者群體，此外，您是否可以詳細說明您預計在多大程度上對美國市場 D-PLEX100 的製造和供應擁有唯一控制權。

Thank you.

謝謝。

Sure, thank you. Good morning. So, the ideal partner is a partner that has Presence in the surgery suite, and the hospital in the surgery suite that has frequent visits to the surgeon.

當然，謝謝。早安.因此，理想的合作夥伴是能夠在手術室中存在的合作夥伴，以及能夠經常拜訪外科醫生的手術室中的醫院。

And the broader the sales force within the surgery suite within the hospital, the better, and you could look at the companies that has presence in this way, divided in a way into two arms. One are the large pharma companies and the other are the large net device companies.

醫院手術室內的銷售團隊越廣泛越好，你可以看看以這種方式存在的公司，以某種方式將其分為兩部分。一類是大型製藥公司，另一類是大型網路設備公司。

Both are very good partners that can and speaking with them frequently for the last few years, I can tell you that they're looking at the area of surgical site infection. Many of them, it's part of their strategy. It's part of the where they're looking to expand their pipeline and in general, when you look at the surgical site infection is a subsection of hospital acquired infection and when you look at the days post COVID, you see.

他們都是非常好的合作夥伴，過去幾年來我經常與他們交談，我可以告訴你，他們正在關注手術部位感染領域。對許多人來說，這是他們策略的一部分。這是他們尋求擴大管道的一部分，一般來說，當你觀察手術部位感染時，你會發現它是醫院獲得性感染的一個子部分，當你觀察 COVID 之後的日子時，你就會看到。

Product that we approved drugs that were approved in this area of hospital acquired infection. After many years where we didn't have any new drug there. And I can tell you that those are being adopted very nicely by clinics and hospitals, and we see ourselves being the first in the area of surgical site infection alongside those new launches that were looking at other things, not necessarily of the portion of pesticides.

我們核准的產品是針對醫院內獲得性感染領域核准的藥物。多年來我們一直沒有任何新藥。我可以告訴你們，這些方法已經被診所和醫院很好地採用了，而且我們認為，我們自己是手術部位感染領域的先驅，同時我們還在研究其他方面（不一定是殺蟲劑的比例）的新產品。

You were also asking about manufacture, so we definitely see ourselves manufacturing the product as part of partnership. We believe this is one of our strengths, bringing a full solution, bringing a product that is fully that being a fully integrated biopharma company, and we spent a lot of effort and time these days to get ready to this stage. This is something that we understand that requires efforts and investment in order to be ready for the commercial stage.

您也詢問了製造情況，因此我們肯定將產品製造視為合作的一部分。我們相信這是我們的優勢之一，提供完整的解決方案，提供完整的產品，作為一家完全整合的生物製藥公司，我們花費了大量的精力和時間來為這個階段做好準備。我們知道，這需要努力和投資才能進入商業階段。

We did have about a year and a half ago a GMP review, commercial stage GMP review by the European and Israeli healthcare, and we're getting ready for the FDA. Inspection that obviously will be after we submit the NDA and this is in all of our discussions something that is in our advantage and also one maybe important thing manufacture is very unique here. It's septic. It's unique. There is a lot of know-how around the manufacturer. And we think this is one of one of our strengths.

大約一年半前，我們確實接受了歐洲和以色列醫療機構的 GMP 審查、商業階段 GMP 審查，並且正在為 FDA 做準備。顯然，在我們提交保密協議後會進行檢查，在我們所有的討論中，這都是對我們有利的事情，也許很重要的一點是，這裡的製造非常獨特。這是敗血症。它是獨一無二的。製造商擁有大量的專業知識。我們認為這是我們的優勢之一。

Ori you want to touch briefly on the aspect of what we believe will stay in our ends and what will be on the responsibility of the partners.

Ori，您想簡單談談我們認為哪些方面將由我們承擔，哪些方面將由合作夥伴承擔。

Yes.

是的。

I'll take it. Hey Ron, good morning. I think so first I think a lot of this will depend on the partner and what the capabilities the partner the partner brings. But I think in the ideal scenario in our preferred scenario.

我要買它。嘿，羅恩，早安。我認為首先，這在很大程度上取決於合作夥伴以及合作夥伴帶來的能力。但我認為，理想情況下這是我們所偏好的情況。

Everything that has to do with the day-to-day activities, the boots on the ground, right, the sales reps, the MSLs, the national accounts that go into the hospitals or by the partner and what we do is more a global view of all the global activities meaning a looking into expansion of indication.

與日常活動有關的一切，包括實地工作、銷售代表、MSL、進入醫院或合作夥伴的國家帳戶，我們所做的更多的是對所有全球活動的全球視野，即研究適應症的擴展。

Looking into a global medical activities publications, HOR kind of global review and looking forward to what else can be done with D-PLEX beyond prevention of a prevention of SSI there's quite a lot that can done with the product.

查看全球醫療活動出版物、HOR 類型的全球評論，並期待除了預防 SSI 之外，D-PLEX 還能做什麼，該產品還可以做很多事情。

So, kind of if you look at it in in in in terms of a of a traditional pharma of the global, the global marketing will stay with us, the global medical affair will stay with us and the global HOR and the day-to-day on the ground activity will be with the partner.

因此，如果你從全球傳統製藥的角度來看，全球行銷將由我們負責，全球醫療事務將由我們負責，全球 HOR 和日常實地活動將由合作夥伴負責。

Thank you. That's very helpful. Just two other quick items, if I may, on the R&D front. Could you perhaps remind us of some of the existing approved APIs for which you already have knowledge, data, evidence that your platform. For would be able to effectively reformulate, potentially reposition and optimize those approved APIs beyond what is in D-PLEX100.

謝謝。這非常有幫助。如果可以的話，我只想簡單談談研發方面的另外兩件事。您能否提醒我們一些現有的已批准的 API，您已經擁有這些 API 的知識、數據和證據來證明您的平台。因為能夠有效地重新制定、重新定位和優化 D-PLEX100 之外的已批准 API。

And then also if you could just elaborate with respect to (immunogenesis), the collaboration that you have there. You know what specific clinical development activities are currently ongoing with their candidates, how you expect your technology to be integrated into the future development plans for that candidate, and how broadly they expect to develop that asset and in combination with what drugs.

然後，如果您可以詳細說明一下（免疫發生）以及您在那裡進行的合作。您知道他們目前正在針對候選藥物進行哪些具體的臨床開發活動，您希望如何將您的技術融入該候選藥物的未來開發計劃中，以及他們希望如何廣泛地開發該資產以及與哪些藥物結合開發。

And you mentioned previously that historically been difficult to deploy as monotherapy because of the short half-life, but do you also think that potentially pairing immunogenesis as candidate with your platform would actually enable it to be more combinable with other existing approved, for example, checkpoint inhibitor modalities for the treatment of solid.

您之前提到過，由於半衰期較短，歷史上很難將其作為單一療法使用，但您是否也認為，將免疫發生作為候選藥物與您的平台配對，實際上可以使其與其他現有已獲批准的藥物更好地結合，例如，用於治療固體的檢查點抑製劑模式。

Thank you.

謝謝。

Thank you.

謝謝。

In terms of the Plex platform and other approved drugs that we have worked with in the past and are working on, I can only relate to those that have been disclosed. We do have in our pipeline some new programs that were not disclosed yet around approved drug and known compound, but I can mention chemotherapy that we've worked with, and we have oncoplex with chemotherapy. We've been doing in the past some work with growth factors and steroids, as well as with Analgetics.

就 Plex 平台以及我們過去合作過和正在研究的其他已批准的藥物而言，我只能涉及那些已經披露的藥物。我們的研發線中確實有一些尚未披露的涉及已批准藥物和已知化合物的新項目，但我可以提及我們已經進行的化療，以及我們的化療腫瘤複合物。我們過去一直在研究生長因子和類固醇以及止痛藥。

All have been tested preclinically, in vivo, in vitro. And I think the potential here is literally we've not even touched the beginning of what could be done around that, and this is the only thing that were these clothes. We are also did some work with things that are not yet approved, for example, SIRNA, some peptides, proteins, as well as be specific.

所有產品均已進行臨床前、體內和體外測試。我認為這裡的潛力實際上我們甚至還沒有觸及可以圍繞這個問題採取的行動的開始，而這些衣服就是唯一的潛力。我們也對一些尚未批准的事物做了一些工作，例如 SIRNA、一些勝肽、蛋白質，以及具體的東西。

So those are in terms of looking at the capability of the platform, we have all of that in our tool kit. And there are some new things that we've been working on in the last two years, and we are waiting for the top line to share this with investors and continue to develop that and hopefully also do that in some sorts of collaboration in areas that are very lucrative.

因此，從平台功能的角度來看，我們的工具包中已經包含了所有這些功能。過去兩年我們一直在研究一些新事物，我們正在等待高層與投資者分享這些事物，並繼續發展這些事物，並希望在利潤豐厚的領域中進行某種形式的合作。

So that in terms of the capability of the PLEX, in terms of the sting agonist, so sting in general has, as you said, have short life, but also tends to be deployed from the tumor very quickly.

因此，就 PLEX 的能力而言，就刺痛激動劑而言，正如您所說，刺痛一般壽命較短，但也往往能很快從腫瘤中展開。

And we think that this, together with the overall very potent. Immune response that this thing has. Being able to deliver the drug locally at the tumor site, avoiding most of the systemic exposure together with having it on a prolonged and continuous basis could overcome those challenges.

我們認為，這一點與整體情況相結合，非常有效。這個東西有免疫反應。能夠將藥物局部輸送到腫瘤部位，避免大部分全身暴露，並長期持續地輸送藥物，可以克服這些挑戰。

Both immunogenesiss thought that this is a good approach to overcome those challenges and make the drug much more efficacious.

兩種免疫學都認為這是克服這些挑戰並使藥物更有效的好方法。

But that is always with or potentially will be also with other modalities and other poetic agents as good as the drug will be, I think patients will only benefit with something that with a combination with immune checkpoint. So that's definitely something that when we get to the preclinical stage.

但這始終或可能也將是與其他方式和其他詩意藥劑一起進行的，儘管藥物效果很好，但我認為患者只有從與免疫檢查點相結合的藥物中受益。所以當我們進入臨床前階段時，這肯定是會發生的事。

We will be looking on that as well, together with immunogenesis.

我們也將對此進行研究，同時關注免疫發生。

What's the best model to show the efficacy of the combined product?

什麼模型最能體現組合產品的功效？

Thank you so much.

太感謝了。

Thank you. As a reminder, if you wish to ask a question, please press one and one.

謝謝。提醒一下，如果您想提問，請按“1”和“1”。

We will now take the next question from the line of Brandon Folkes from Rodman & Renshaw. Please go ahead.

我們現在來回答來自 Rodman & Renshaw 的 Brandon Folkes 提出的下一個問題。請繼續。

Hi, thanks for taking my questions and congratulations on all the progress. Maybe just firstly from me, you talked about the potential label language, right? Being sort of maybe just abdominal surgery or large incisions.

你好，感謝您回答我的問題，並祝賀您取得的所有進展。也許首先從我的角度來說，您談到了潛在的標籤語言，對嗎？可能只是腹部手術或大切口。

Can you just talk about the pushes and pulls that we should expect in terms of the different label language possibilities, is it just how compelling the Shield 2 results are?

您能否談談我們應該在不同的標籤語言可能性方面預期到的推拉因素，Shield 2 的結果是否非常引人注目？

How much color do you think you get sort of post-Shield 2 in terms of where the label may be going or you know how much color a partner may get post-Shield 2 versus sort of this just being regular way you submit the NDA for the broadest indication and sort of during regular way approval process kind of that's where you get the color on the label.

就標籤可能出現的位置而言，您認為在 Shield 2 之後您會得到多少種顏色，或者您知道合作夥伴在 Shield 2 之後會得到多少種顏色，而不是像常規方式那樣，您提交 NDA 以獲得最廣泛的適應症，並且在常規方式的批准過程中，您可以在標籤上獲得顏色。

So I'm not sure I got all your points. We had there was some GAAP in the line, but if I missed anything, please Brandon, add.

所以我不確定我是否理解了你的全部觀點。我們的線路中有一些 GAAP，但如果我遺漏了什麼，請 Brandon 添加。

Some of that. I think that obviously the most important thing is the phase 3 data and how efficacious it will be. If you recall, we also had in shield one in this on this pre-specified subgroup that is now. The basis of shield 2 an effect on reintervention and mortality that could also be influence make an influence on the way the agency see the data.

其中一些。我認為顯然最重要的是第三階段的數據及其有效性。如果您還記得的話，我們還在這個預先指定的子群組中封鎖了一個。盾牌 2 的基礎對再乾預和死亡率有影響，這也可能影響該機構查看數據的方式。

We also have in the studies a group of patients that are not part of the primary endpoint but that had smaller incisions, so about 170 patients out of Shield 2. That are not part of the primary. They are on top of the 800 that are the primary and smaller incision. So we'll need to look at the data together with the agency, but our plan is to immediately meet the FDA to free NDA meeting.

我們在研究中還有一組不屬於主要終點但切口較小的患者，因此第 2 盾中約有 170 名患者。這不是主要部分。它們位於 800 個主要較小切口的頂部。因此，我們需要與該機構一起查看數據，但我們的計劃是立即與 FDA 會面以免費召開 NDA 會議。

And obviously, once we sit with the agency, we will also start the discussions around label and label expansion.

顯然，一旦我們與經紀公司坐下來，我們也將開始討論唱片公司和唱片公司擴張的問題。

Thanks, that's very helpful. And then maybe just secondly, just a bit more sort of strategically post a partnership, how do we think about PolyPid's capital allocation and development strategy? Obviously we expect you to sort of deploy funds into future development of your indications across the platform which you partner out, but Yeah, do you look to take those molecules through the approval process as you've done with D-PLEX100, or do you look at perhaps a partnering strategy earlier stage, given the validation that a D-PLEX100 approval would bring to the platform?

謝謝，這非常有幫助。其次，從策略角度來說，建立合作關係後，我們如何看待 PolyPid 的資本配置和發展策略？顯然，我們希望您能夠將資金部署到您合作的平台上的適應症的未來開發中，但是，是的，您是否希望像對待 D-PLEX100 一樣讓這些分子通過審批流程，或者考慮到 D-PLEX100 批准將為平台帶來的驗證，您是否考慮在早期階段採取合作策略？

Thank you.

謝謝。

We look at the, thank you, that's a very good question and it's important to stress this. We look at the partnering earlier.

我們來看看，謝謝，這是一個非常好的問題，強調這一點很重要。我們之前就討論過合作關係。

Not just because obviously because of the validation that we have from D-PLEX100, but also because of the area that we are choosing for our next in line and those that we've disclosed and those that we have not disclosed yet that are in area where pharma company partnering are partnering at a much earlier stage. So we look to partner earlier and have most of the heavy lifting in terms of the clinical development done either by the partner or together with the partner.

這顯然不僅是因為我們從 D-PLEX100 獲得了驗證，還因為我們選擇的下一個領域以及我們已經披露的領域和尚未披露的領域，這些領域是製藥公司合作夥伴在早期階段開展合作的領域。因此，我們希望儘早建立合作關係，並讓合作夥伴或與合作夥伴共同完成臨床開發的大部分繁重工作。

Great, thanks very much and congrats on all the progress.

太好了，非常感謝，並祝賀你取得的所有進展。

Thank you.

謝謝。

Thank you.

謝謝。

I would now like to turn the conference back to the Dikla Czaczkes Akselbrad for closing remarks.

現在，我想請 Dikla Czaczkes Akselbrad 致閉幕詞。

Thank you for joining PolyPid's Fourth Quarter and Full Year 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, and look forward to enrollment completion and top line results.

感謝您參加 PolyPid 2024 年第四季和全年財報電話會議。我們對我們的長期前景仍然充滿信心，特別是我們有前景的後期候選產品 D-PLEX100 的潛力，並期待註冊完成和頂線結果。

As always, we are grateful to our team members, shareholders, and all external partners for their commitment to our mission and support in continuing to advance toward our goal of bringing D-PLEX100 to healthcare providers and patients as quickly as possible. We look forward to speaking with you again on our next conference call.

像往常一樣，我們感謝我們的團隊成員、股東和所有外部合作夥伴對我們使命的承諾和支持，幫助我們繼續朝著盡快將 D-PLEX100 帶給醫療保健提供者和患者的目標邁進。我們期待在下次電話會議上再次與您交談。

This concludes today's conference call.

今天的電話會議到此結束。

Thank you for participating. You may now disconnect.

感謝您的參與。您現在可以斷開連線。