PolyPid Ltd (PYPD) 2025 Q2 法說會逐字稿

Greetings and welcome to PolyPid second quarter 2025 conference call. (Operator Instructions) As a reminder, this call is recorded. And I would now like to introduce your host for today's conference, Yehuda Leibler, from ARX Capital Markets. Mr. Leibler, you may begin.

問候並歡迎參加 PolyPid 2025 年第二季電話會議。（操作員指示）提醒一下，此通話已被錄音。現在我想介紹今天會議的主持人，來自 ARX Capital Markets 的 Yehuda Leibler。萊布勒先生，您可以開始了。

Thank you all for participating in PolyPid's second quarter 2025 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 2025 年第二季財報電話會議。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 ended June 30, 2025. A copy of the press release is available in the investors section on the company's website, available at www.polypid.com. I'd like to remind you that on this call, management will make forward-looking statements within the meaning of the Federal securities law.

今天早些時候，PolyPid 發布了截至 2025 年 6 月 30 日的三個月的財務業績。新聞稿副本可在本公司網站 www.polypid.com 的投資者專區查閱。在此提醒您，管理階層將在本次電話會議上根據聯邦證券法做出前瞻性陳述。

For example, management is making forward-looking statements when it discusses D-PLEX100's potential benefits, including its potential to address a significant unmet medical need and to substantially reduce the burden of surgical site infections, improve patient outcomes, and generate meaningful healthcare cost savings.

例如，管理層在討論 D-PLEX100 的潛在益處時做出了前瞻性陳述，包括其解決重大未滿足醫療需求的潛力、大幅減輕手術部位感染負擔、改善患者預後以及產生有意義的醫療成本節約的潛力。

The expected regulatory submissions and their timing, the aim of GLP-1 program and its potential to address significant unmet medical needs in the treatment of metabolic diseases, the company's expected cash runway, and the potential partnership opportunities for D-PLEX100.

預期的監管提交及其時間、GLP-1 計劃的目標及其解決代謝疾病治療中重大未滿足醫療需求的潛力、公司預期的現金流以及 D-PLEX100 的潛在合作機會。

Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond the company's control, including the risks described from time to time in its SEC filings. The company's results may differ materially from these projections. These statements involve material risks and uncertainties that could cause actual results or events to materially differ.

前瞻性陳述受多種風險和不確定性的影響，其中許多超出了公司的控制範圍，包括公司不時在提交給美國證券交易委員會的文件中描述的風險。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。

Accordingly, you should not place undue reliance on these statements. I encourage you to review the company's filings with the SEC, including without limitation, the company's annual report on its Form 20-F filed on February 26, 2025, 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聲明。我鼓勵您查看公司向美國證券交易委員會提交的文件，包括但不限於公司於 2025 年 2 月 26 日提交的 20-F 表年度報告，其中指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, August 13, 2025. With the completion of those prepared remarks, it is my pleasure to turn the call over to Dikla Czaczkes Akselbrad, CEO of PolyPid. Dikla?

PolyPid 不承擔任何更新或修改任何財務預測或前瞻性聲明的意圖或義務，除非法律要求，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，並且僅截至今天（2025 年 8 月 13 日）的現場直播。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, Yehuda. On behalf of our team at PolyPid, I would like to welcome everyone to our second quarter 2025 earnings conference call.

謝謝你，耶胡達。我謹代表 PolyPid 團隊歡迎大家參加我們 2025 年第二季財報電話會議。

The second quarter of 2025 was truly transformational for PolyPid, marked by the successful results of our SHIELD II Phase 3 trial, which demonstrated significant clinical benefits of D-PLEX100 in preventing surgical site infections, or SSI and abdominal colorectal surgeries.

2025 年第二季度對於 PolyPid 來說是真正的轉型期，標誌著我們的 SHIELD II 第 3 階段試驗取得了成功，證明了 D-PLEX100 在預防手術部位感染或 SSI 和腹部結直腸手術方面具有顯著的臨床益處。

As announced in June 2025, the study showed a statistically significant reduction of 38% with a p-value below 0.005 in the primary endpoint, which, as a reminder, is the combination of deep and superficial exercise, all-cause mortality, and surgical reintervention.

正如 2025 年 6 月宣布的那樣，該研究顯示，主要終點具有統計意義的 38% 的減少，p 值低於 0.005，提醒一下，這是深層和淺層運動、全因死亡率和手術再乾預的結合。

In addition, we demonstrated a robust 58% reduction in the rate of surgical site infections in patients treated with D-PLEX100 versus standards of care with a p-value below 0.005, including a significant reduction in deep surgical site infection. With five cases of this exercise representing approximately 14% out of all exercise in the standard of care arm versus zero in D-PLEX100 arm with a p-value below 0.05.

此外，我們證明，與標準治療相比，接受 D-PLEX100 治療的患者的手術部位感染率顯著降低了 58%，p 值低於 0.005，其中包括深部手術部位感染顯著減少。標準護理組中有 5 例此類鍛煉，佔所有鍛煉的約 14%，而 D-PLEX100 組中沒有此類鍛煉，p 值低於 0.05。

Importantly, we also saw in the study a clear and statistically significant 62% reduction of patients with an ASEPSIS score over 20. The ASEPSIS score reflects the severity of the wound infection appearance and the clinical consequences of the infection.

重要的是，我們在研究中也發現 ASEPSIS 評分超過 20 的患者數量明顯減少了 62%，具有統計意義。ASEPSIS評分反映了傷口感染外觀的嚴重程度和感染的臨床後果。

So D-PLEX100 not only markedly decreases the rate of superficial and deep exercise, but even when exercise occurred in the D-PLEX100 arm, they were less severe and caused less medical burden, such as prolonged hospitalization or use of IV antibiotics.

因此，D-PLEX100 不僅顯著降低了淺層和深層運動的頻率，即使在 D-PLEX100 組中進行運動，其嚴重程度也較小，造成的醫療負擔也較小，例如延長住院時間或使用靜脈注射抗生素。

These robust results validated our conviction in D-PLEX100 potential to address a significant unmet medical need and have generated substantial interest from potential commercial partners. We are extremely encouraged by the enthusiastic reception from healthcare professionals, lead surgeons in different types of surgeries, as well as thought leaders in the field of surgical site infection.

這些強勁的結果證實了我們對 D-PLEX100 解決重大未滿足醫療需求的潛力的信念，並引起了潛在商業合作夥伴的極大興趣。我們受到醫療保健專業人士、不同類型手術的首席外科醫生以及手術部位感染領域的思想領袖的熱烈歡迎，這讓我們感到非常鼓舞。

All recognize D-PLEX100 potential to substantially reduce the burden of surgical site infections, improve patient outcomes, and generate meaningful healthcare cost savings. In addition, further analysis of the Phase 3 SHIELD II trial safety data revealed a good safety profile with no difference in serious treatment emergent adverse event between patients treated with D-PLEX100 versus standard of care.

所有人都認識到 D-PLEX100 具有大幅減輕手術部位感染負擔、改善患者預後並顯著節省醫療成本的潛力。此外，對 3 期 SHIELD II 試驗安全數據的進一步分析顯示，安全性良好，接受 D-PLEX100 治療的患者與接受標準治療的患者在嚴重治療出現的不良事件方面沒有差異。

This safety profile further supports the D-PLEX100 potential as a well-tolerated prophylactic treatment option for patients undergoing major abdominal surgeries. Following this positive Phase 3 data, we are on track with our new drug application or NDA preparation. Our next steps include a pre-NDA meeting with the FDA planned by the end of this year, leveraging our fast track and breakthrough therapy designation to facilitate regulatory review.

此安全性進一步支持了 D-PLEX100 作為接受大型腹部手術的患者的一種耐受性良好的預防性治療選擇的潛力。根據這一積極的第三階段數據，我們的新藥申請或 NDA 準備工作正在按計劃進行。我們的下一步包括計劃在今年年底前與 FDA 舉行一次 NDA 前會議，利用我們的快速通道和突破性療法認定來促進監管審查。

We anticipate submitting the NDA to the FDA in early 2026 and marketing authorization application or MAA submission in Europe shortly thereafter.

我們預計將於 2026 年初向 FDA 提交 NDA，隨後不久在歐洲提交行銷授權申請或 MAA。

Shifting gears, we recently made significant progress on our GLP-1 program, which leverages the company's extensive long-term experience. This initiative aims to deliver approximately 60 days, no burst GLP-1 receptor agonist attacks for improved patient compliance and enhanced therapeutic outcomes in the rapidly growing weight loss and diabetes market.

換個角度來看，我們最近在 GLP-1 專案上取得了重大進展，該專案利用了公司豐富的長期經驗。該計劃旨在提供約 60 天無爆發性 GLP-1 受體激動劑攻擊，以提高患者的依從性並增強快速增長的減肥和糖尿病市場的治療效果。

We have formally unveiled this program early in the current quarter, and we believe it represents an exciting opportunity to expand our therapeutic footprint into the fast growing metabolic disease market.

我們已於本季初正式公佈了該計劃，我們相信這是一個令人興奮的機會，可以將我們的治療足跡擴展到快速增長的代謝疾病市場。

Following the end of the quarter yesterday, we announced the appointment of Dr. Nurit Tweezer-Zaks, MD, MBA, as Chief Medical Officer of the company transitioning from a role on PolyPid's Board of Directors. Dr. Tweezer-Zaks bring extensive medical R&D and business development expertise to this executive position, strengthening the company's leadership team as it advanced towards NDA submission and commercial preparations following the positive Phase 3 SHIELD II result.

昨天本季結束後，我們宣布任命 Nurit Tweezer-Zaks 博士（醫學博士、工商管理碩士）為公司首席醫療官，此前他曾擔任 PolyPid 董事會成員。Tweezer-Zaks 博士為這一高管職位帶來了豐富的醫療研發和業務開發專業知識，增強了公司的領導團隊，使其在 SHIELD II 第三階段取得積極成果後朝著 NDA 提交和商業準備的方向前進。

From a financial perspective, we have significantly strengthened our balance sheet through a successful warrant exercise inducement transaction, extending our cash run way well into 2026. With that, I will now turn the call over to Ori, our COO of US, to provide more details on our commercial preparations and partnering efforts for D-PLEX100.

從財務角度來看，我們透過成功的認股權證行使誘導交易顯著增強了我們的資產負債表，將我們的現金流量延長至 2026 年。現在，我將把電話轉給我們的美國營運長 Ori，以提供有關 D-PLEX100 的商業準備和合作努力的更多細節。

Thank you, Dikla. Following the successful completion of the Phase 3 SHIELD II trial efficacy data, we have intensified our commercial preparation activities and partnership discussions. We believe that the positive Phase 3 results have validated the substantial market opportunity for D-PLEX100.

謝謝你，迪克拉。在成功完成第 3 階段 SHIELD II 試驗效力資料後，我們加強了商業準備活動和合作討論。我們相信，第三階段的正面成果已經驗證了 D-PLEX100 的巨大市場機會。

To reiterate, based on [QVR] data, we believe the total addressable market for D-PLEX100 in the US is just over 12 million total surgeries annually, with approximately 4.4 million of those being abdominal surgeries and an additional 2.1 million abdominal procedures principally in gynecology and neurology.

重申一下，根據 [QVR] 數據，我們認為 D-PLEX100 在美國的整體潛在市場每年總計略高於 1,200 萬例手術，其中約 440 萬例為腹部手術，另外還有 210 萬例腹部手術，主要涉及婦科和神經科。

The 58% reduction in SSI demonstrated in the Phase 3 trial is particularly significant when considering the substantial cost associated with SSI. As a reminder, SSIs are estimated to cost the US healthcare system up to $10 billion annually, extending the hospital length of stay by 9.7 days on average and increased hospitalization cost by more than $20,000 per patient admission.

考慮到與 SSI 相關的巨額成本，第 3 階段試驗中顯示的 SSI 減少 58% 尤為重要。提醒一下，據估計，SSI 每年為美國醫療保健系統造成高達 100 億美元的損失，平均延長住院時間 9.7 天，每位患者入院的住院費用增加 20,000 多美元。

D-PLEX100's potential ability to significantly reduce this infection rates represent a compelling value proposition for healthcare systems, pairs, and most importantly, for patients. With respect to our partnership strategy, we continue to believe that identifying a US partner with a dedicated hospital-focused sales force and significant resources will enable D-PLEX100 to maximize its sales potential in the US.

D-PLEX100 具有顯著降低感染率的潛在能力，這對醫療保健系統、夫婦以及最重要的患者來說是一個極具吸引力的價值主張。關於我們的合作夥伴策略，我們仍然相信，找到一個擁有專門的醫院銷售團隊和大量資源的美國合作夥伴將使 D-PLEX100 最大限度地發揮其在美國的銷售潛力。

Following the positive Phase 3 data announcement, we have seen increased interest on potential partners, and we are currently evaluating relevant opportunities. We will of course provide updates on these discussions as appropriate.

在第三階段的積極數據公佈之後，我們看到對潛在合作夥伴的興趣增加，我們目前正在評估相關機會。我們當然會在適當的時候提供這些討論的最新消息。

For the European market, as we've mentioned previously, we already have an exclusive licensing agreement in place with ADVANZ PHARMA to commercialize D-PLEX100 across European countries. And we are actively working together to plan and implement pre-launch activities to maximize D-PLEX100's anticipated launch in Europe. And with that, I will now turn the call over to our CFO, Jonny, to review our financial results. Jonny?

對於歐洲市場，正如我們之前提到的，我們已經與 ADVANZ PHARMA 達成獨家許可協議，在歐洲國家商業化 D-PLEX100。我們正在積極合作，規劃和實施發布前的活動，以最大限度地促進 D-PLEX100 在歐洲的預期發布。現在，我將把電話交給我們的財務長喬尼 (Jonny)，以審查我們的財務結果。喬尼？

Thank you, Ori. We are pleased to report our financial results for the second quarter of 2025, which reflects our continued investments in advancing our pipeline, while maintaining fiscal discipline.

謝謝你，Ori。我們很高興地報告 2025 年第二季的財務業績，這反映了我們在推進產品線方面的持續投資，同時保持了財務紀律。

Starting with our balance sheets as of June 30, 2025, the company had cash and cash equivalent of $17.4 million and short term deposits of $12 million for a total of $29.5 million. This represents a significant improvement from our cash position of $15.6 million as of December 31, 2024. The increase was primarily driven by successful warrant exercise inducement and business transaction that Dikla mentioned earlier. We expect that our current cash balance will be efficient to fund operations well in 2026.

從我們截至 2025 年 6 月 30 日的資產負債表來看，該公司擁有現金和現金等價物 1,740 萬美元，短期存款 1,200 萬美元，總計 2,950 萬美元。這比我們截至 2024 年 12 月 31 日的 1560 萬美元的現金狀況有了顯著改善。這一增長主要得益於 Dikla 先前提到的成功行使認股權證的誘因和商業交易。我們預計，我們目前的現金餘額將足以為 2026 年的營運提供充足的資金。

Now turning to our income statements for the three months ended June 30, 2025, research and development expenses were $6.2 million compared to $4.8 million in the same period of 2024. The increase was primarily due to activities related to the completion of the SHIELD II Phase 3 trial and preparations for regulatory submissions.

現在來看看截至 2025 年 6 月 30 日的三個月的損益表，研發費用為 620 萬美元，而 2024 年同期為 480 萬美元。成長主要歸因於完成 SHIELD II 第 3 階段試驗和準備提交監管申請的相關活動。

General and administrative expenses were $2.5 million compared to $1.1 million for the same period of 2024. The increase was primarily due to non-cash expenses related to performance-based options or PSUs uses following the successful SHIELD II to Phase 3 retrial, which triggered the vesting of the PSUs.

一般及行政開支為 250 萬美元，而 2024 年同期為 110 萬美元。成長的主要原因是 SHIELD II 至第 3 階段重審成功後，與基於績效的選擇權或 PSU 使用相關的非現金支出，觸發了 PSU 的歸屬。

Marketing and development expenses were $0.7 million compared to $0.3 million for the same period of 2024. For the second quarter of 2025, the company had a net loss of $10 million or $0.78 per share, compared to a net loss of $6.3 million or $1.25 per share in the second quarter of 2024.

行銷和開發費用為 70 萬美元，而 2024 年同期為 30 萬美元。2025 年第二季度，該公司淨虧損 1,000 萬美元，即每股 0.78 美元，而 2024 年第二季淨虧損 630 萬美元，即每股 1.25 美元。

For the six months ended June 30, 2025. R&D expenses were $12.3 million compared to $9.8 million for the same six month period of 2024. G&A expenses were $3.7 million compared to $2.1 million for the same period of 2024. Marketing and business development expenses were $1 million compared to $0.5 million for the same period of 2024.

截至 2025 年 6 月 30 日的六個月。研發費用為 1,230 萬美元，而 2024 年同期為 980 萬美元。一般及行政費用為 370 萬美元，而 2024 年同期為 210 萬美元。行銷和業務開發費用為 100 萬美元，而 2024 年同期為 50 萬美元。

The company had a net loss of $18.2 million or $1.48 per share compared to a net loss of $12.7 million or $2.62 per share in the six months period ended June 30, 2024. With that, we want to open the call to your questions. Operator?

該公司淨虧損為 1,820 萬美元，即每股 1.48 美元，而截至 2024 年 6 月 30 日的六個月期間淨虧損為 1,270 萬美元，即每股 2.62 美元。藉此機會，我們想開始回答你們的問題。操作員？

(Operator Instructions)

（操作員指示）

Chase Knickerbocker, Craig-Hallum.

蔡斯·尼克博克、克雷格·哈勒姆。

Morning, thanks for taking the questions, maybe it's on the NDA filing. So if I think about what is kind of left to be done between now and 1Q, can you kind of walk us through the larger items and then, for particularly obviously on the CMC side, can you talk about your preparations as they continue to progress on (technical difficulty), et cetera and is always preparing for that 1Q filing?

早安，感謝您回答問題，也許是關於保密協議 (NDA) 的提交。因此，如果我考慮一下從現在到第一季度還有哪些工作要做，您能否向我們介紹一下較大的項目，然後，特別是在 CMC 方面，您能否談談隨著他們繼續取得進展（技術難度）等而進行的準備工作，並且始終為第一季度的備案做準備？

Sure. Hi, good morning, Jack. We are in the finalization stages of the CMC and the clinical module. So this will be the first that we will submit. There are some data points that are still being collected and obviously the preparation itself and the finalization of the document is taking time, but those documents have already been reviewed by our external FDA consultants as a first step.

當然。嗨，早上好，傑克。我們正處於 CMC 和臨床模組的最後階段。這是我們提交的第一份報告。一些數據點仍在收集中，顯然準備工作本身和文件的最終定稿需要時間，但這些文件已經由我們的外部 FDA 顧問進行了第一步審查。

And we are now preparing, first of all, the CSR and all the package for pre-NDA meaning that (technical difficulty) and we would like to meet with the FDA before the end of this year for pre-NDA meeting to get an agreement, while we are prior to submitting the NDA and then early 2026, the first quarter to submit the NDA. In parallel to that, obviously, we are in preparation for the (technical difficulty) review. This is something that is ongoing.

我們現在首先正在準備 CSR 和所有用於 pre-NDA 的方案，這意味著（技術難度），我們希望在今年年底之前與 FDA 會面，舉行 pre-NDA 會議以達成協議，同時我們將在提交 NDA 之前，然後在 2026 年初，即第一季度提交 NDA。同時，顯然我們正在為（技術難度）審查做準備。這是正在進行的事情。

The facility has been reviewed a couple of times already both by the Israel Ministry of Health and European QP, but still there is always the room to prepare further for an FDA review and get it ready for the commercialization state.

該設施已經接受過以色列衛生部和歐洲 QP 的多次審查，但仍有空間進一步準備 FDA 審查並為商業化做好準備。

So to summarize, we will be submitting in the next few weeks a pre-NDA and meeting request which we expected to during the year. And early next year Q1, we will submit the NDA.

總而言之，我們將在接下來的幾週內提交一份預先保密協議和會議請求，我們預計在今年內完成。明年第一季初，我們將提交保密協議。

Got it. Maybe just one on can you talk about kind of the path forward for the GLP-1 program as far as when we might see some data there and kind of, early stage plans in that program?

知道了。也許只有一個，您能否談談 GLP-1 計劃的未來發展方向，例如我們何時可以看到一些數據以及該計劃的早期計劃？

And then just second last for me if we think about the ADVANZ partnership, when should we expect some potential milestones from that to post data is that mainly going to be regulatory or should there be anything that triggers from the data itself from the Phase 3?

然後，對我來說，倒數第二個問題是，如果我們考慮 ADVANZ 合作夥伴關係，我們應該何時期待從中發布一些潛在的里程碑數據，這主要是監管方面的，還是應該從第 3 階段的數據本身觸發任何事情？

Sure, so for the GLP-1 which is a program that we're very excited both because of the broader consequences of it of having (technical difficulty), that is released injected in a form that the support an average of 50 or about 60 days of content (technical difficulty), but also this being a field (technical difficulty) patient that still do not benefit from the current medication and do not being quite harsh on this medication.

當然，對於 GLP-1 項目，我們感到非常興奮，因為它具有更廣泛的後果（技術難度），以注射的形式釋放，支持平均 50 或 60 天的內容（技術難度），而且這是一個領域（技術難度）患者仍然無法從目前的藥物中受益，並且對這種藥物不太苛刻。

So what we think is our main benefit from both the prolonged, both the aspects that we can have a relatively longer than what is out there drug and also the aspect of avoiding the first characterizing current regimen of treatment.

因此，我們認為我們的主要好處是可以延長療程，一方面我們可以獲得比現有藥物更長的療程，另一方面可以避免目前治療方案的第一個特徵。

In terms of the timeline, we are now going into mobile class big clinical studies. So what we would like to show is both of this indicates support the release profile that we see in cells in PK studies in the bloodstream. This is also I think very important for that potential partner.

從時間表上看，我們現在正在進入移動級大型臨床研究。因此，我們想要表明的是，這兩者都支持我們在血液 PK 研究中在細胞中看到的釋放概況。我認為這對於潛在合作夥伴來說也非常重要。

And at this stage, we see this program the semaglutide started with the GLP-1, but this could be extended being pursued into the clinic with collaboration with one of the large players in this field.

在這個階段，我們看到這個 semaglutide 計畫是從 GLP-1 開始的，但透過與該領域的大型企業合作，它可以擴展到臨床。

And then just on the ADVANZ partnership.

然後是關於 ADVANZ 合作。

I just wanted some (technical difficulty) because we're getting some messages that the line is not great, so please tell us if we need to repeat anything that was said earlier.

我只是想要一些（技術困難），因為我們收到一些訊息說線路不太好，所以如果我們需要重複之前說過的任何內容，請告訴我們。

So regarding ADVANZ partnership, we are in active and continue -- the partnership is active and continuous both through the clinical stage as well as now in preparation for the submission and as part of the relationship ADVANZ would also be reviewing the MAA submission and the question was where should we expect milestone. So definitely there is a milestone that is expected.

因此，關於 ADVANZ 合作夥伴關係，我們正在積極並繼續 - 合作夥伴關係在臨床階段以及現在的提交準備中都是積極和持續的，作為關係的一部分，ADVANZ 還將審查 MAA 提交，問題是我們應該在哪裡期待里程碑。因此，我們肯定會期待一個里程碑。

As more than three years have passed since we've signed with them, both ADVANZ and I think that there are some adjustments that needs to be assessed that this is what we're doing now. I don't expect it to take too long and once there is anything to announce around that, we will obviously announce.

由於我們與他們簽約已經三年多了，ADVANZ 和我都認為需要進行一些調整，這就是我們現在正在做的事情。我預計這不會花費太長時間，一旦有任何消息要宣布，我們當然會宣布。

But as I said before, we are very pleased with the relationship. There is a trust that has been built during the years and appreciate ADVANZ, now starting to, put more effort into the pre-launch activity, so both parties have an interest to finalize this as soon as possible.

但正如我之前所說，我們對這種關係非常滿意。多年來，雙方建立了信任，並感謝 ADVANZ 現在開始在發布前活動中投入更多精力，因此雙方都有興趣盡快完成此事。

Roy Buchanan, Citizens.

羅伊‧布坎南，《公民報》。

Okay great thanks the line is much better now, I guess, I'm not sure if she's on the call, but I had a couple for Dr. Tweezer-Zaks. So is she here? Can you guys hear me?

好的，非常感謝，我想現在線路好多了，我不確定她是否在通話中，但我有幾個問題想問 Tweezer-Zaks 博士。那麼她在這裡嗎？你們聽得到我說話嗎？

Can you please repeat the question?

您能重複一下這個問題嗎？

Oh, the line is bad again. Yeah, I'll try to repeat it. So if Dr. Tweezer-Zaks is on, I was going to ask, I guess the most compelling reason for joining the company as Chief Medical Officer. D-PLEX100 or the broader PLEX platform if you could just comment on that and then what she's going to focus on, I guess most intactly for the next 12 to 24 months.

噢，線路又壞了。是的，我會嘗試重複一遍。因此，如果 Tweezer-Zaks 博士來的話，我想問一下，我猜加入公司擔任首席醫療官的最令人信服的理由是什麼。如果您能就 D-PLEX100 或更廣泛的 PLEX 平台發表評論，那麼她將重點關注什麼，我想在接下來的 12 到 24 個月內最完整地關注什麼。

Sure. So well, I think this is a really nice addition for our management team. And it's nice because Dr. Tweezer-Zaks was in Board for almost two years, so she knows the team intimately, she knows the programs intimately, she knows the good and the bad and everything and still obviously she could choose also other position, but she decided to join us. And I think she she's going to be a great addition to the team.

當然。所以，我認為這對我們的管理團隊來說是一個非常好的補充。這很好，因為 Tweezer-Zaks 博士在董事會任職近兩年，所以她非常了解團隊，非常了解項目，她知道好的和壞的以及一切，顯然她也可以選擇其他職位，但她決定加入我們。我認為她將成為團隊的一大助力。

With regards to how we view the CMO position and what is going to be a role going forward? Specifically, looking at the coming two years or so, we are now in the position to start to do some pre-launch activities, some pre-commercialization activities as well as for all the regulatory approvals, we have a great data that we want to have it all in front of -- as much as possible, data will obviously like to put it in the best peer-reviewed journal.

關於我們如何看待 CMO 職位以及未來其將扮演什麼角色？具體來說，展望未來兩年左右，我們現在可以開始進行一些上市前活動、一些商業化前活動以及所有監管部門的批准，我們擁有大量數據，我們希望盡可能地將這些數據放在最好的同行評審期刊上。

As far as the preparation, maintaining robust clinical advisory report to support broadening the launch activity. We have (technical difficulty), which is another pointer. We would like, assistance in directing (technical difficulty), I believe this program.

就準備工作而言，保持強大的臨床諮詢報告以支持擴大發布活動。我們有（技術難度），這是另一個指標。我們希望能夠協助指導（技術難題），我相信這個節目。

Okay, great thank you. And I'm getting feedback heading into the likely approval and launch next year, undoubtedly you'd like to bolster the balance sheet further. I guess you just have a preferred way and maybe answer this with ADVANZ response, but do you have a preferred way to do that non-diluted way via partnering or something else? Can you just comment on that?

好的，非常感謝。我得到的回饋是，明年可能會獲得批准並推出，毫無疑問，您希望進一步增強資產負債表。我猜您只是有一種偏好的方式，也許可以用 ADVANZ 的回應來回答這個問題，但是您是否有一種偏好的方式，透過合作或其他方式來實現這種非稀釋的方式？您能對此發表評論嗎？

Sure. We expect that we'll get. What was the second portion of the question?

當然。我們期望我們能夠得到。問題的第二部分是什麼？

If you had a preferred way for bolstering the balance sheet on that for the launch and all of those expensive things.

如果您有一種首選的方式來增強資產負債表，用於發布和所有那些昂貴的事情。

So as we said, for quite some time, we are also looking to collaborate around that, so portion of obviously of, the (technical difficulty) will be financed and taken by our partners. And in terms of other activities, again we do rely on payments that we expect will be coming from our existing partners as well as new partners.

正如我們所說，很長一段時間以來，我們也一直在尋求圍繞這一問題的合作，因此顯然部分（技術難題）將由我們的合作夥伴提供資金和承擔。就其他活動而言，我們確實依賴我們預期來自現有合作夥伴和新合作夥伴的付款。

Apologies. We do seem to be having technical issues. If I could hand back for closing remarks.

抱歉。我們確實似乎遇到了技術問題。如果我可以回來做結束語。

Truly apologizing for that. Thank you for joining PolyPid's second quarter 2025 earnings conference call. The second quarter of 2025 was pivotal period for PolyPid. The positive SHIELD II Phase 3 result represents a significant milestone in our journey to begin to bring D-PLEX100 to market.

對此我深感抱歉。感謝您參加 PolyPid 2025 年第二季財報電話會議。2025 年第二季是 PolyPid 的關鍵時期。SHIELD II 第 3 階段的正面成果代表我們將 D-PLEX100 推向市場的重要里程碑。

We are now focused on preparing our regulatory submissions, advancing our commercial preparations, and exploring partnership opportunities to maximize the value of D-PLEX100. We are also excited about the progress we have made in extending our pipeline with the GLP-1 program, which leverages our extensive long-term experience to address significant unmet need in the treatment of metabolic disease.

我們現在專注於準備監管提交文件、推進商業準備並探索合作機會，以最大限度地提高 D-PLEX100 的價值。我們也對透過 GLP-1 計畫擴展我們的產品線所取得的進展感到興奮，該計畫利用我們豐富的長期經驗來解決代謝疾病治療中尚未滿足的重大需求。

As always, we are grateful to our team members, shareholders, and all external partners for their commitment to our mission. We look forward to speaking with you again on our next conference call, and if anyone wants to further ask questions that were not asked on the call, please reach out to us.

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對我們使命的承諾。我們期待在下次電話會議上再次與您交談，如果有人想進一步詢問電話中未提出的問題，請與我們聯絡。

This concludes today's conference call. Thank you for participating. You may now disconnect.

今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。

The following transcript falls below LSEG's quality threshold due to poor audio. This file has been reviewed to minimize indiscernible language.

由於音訊品質較差，以下記錄未達到 LSEG 的品質閾值。該文件已經過審查，以盡量減少難以辨認的語言。