PolyPid Ltd (PYPD) 2026 Q1 法說會逐字稿

Greetings, and welcome to PolyPid's first-quarter 2026 earnings conference call. (Operator Instructions)

各位好，歡迎參加 PolyPid 2026 年第一季財報電話會議。（接線員指示）

As a reminder, this call is recorded.

提醒各位，本次電話會議將被錄音。

And I would now like to introduce your host for today's conference, Yehuda Leibler from ARX Investor Relations. Mr. Leibler, you may begin.

現在我想介紹今天會議的主持人：來自 ARX Investor Relations 的 Yehuda Leibler 先生。Leibler 先生，您可以開始了。

Thank you, operator, and thank you all for joining PolyPid's first-quarter 2026 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.

謝謝接線員，也感謝各位參加 PolyPid 2026 年第一季財報電話會議。今天與我一同出席的有：PolyPid 執行長 Dikla Czaczkes Akselbrad、PolyPid 財務長 Jonny Missulawin，以及 PolyPid 美國營運長 Ori Warshavsky。

Earlier today, PolyPid released its financial results for the three months ended March 31, 2026. A copy of the press release is available on the Investors section of the company's website 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 laws.

今天稍早，PolyPid 已公布截至 2026 年 3 月 31 日止三個月的財務結果。新聞稿可於公司網站 www.polypid.com 的投資人專區取得。我想提醒各位，在本次電話會議中，管理層將依據聯邦證券法的定義發表前瞻性陳述。

For example, management is making forward-looking statements when discussing the company's regulatory strategy, including the expected completion of the rolling New Drug Application, or NDA submission, for D-PLEX100.

例如，當管理層討論公司的法規策略時，包括預期完成 D-PLEX100 的滾動式新藥申請（NDA）提交，即屬前瞻性陳述。

Management may also discuss the company's planned engagements with the European Medicines Agency, or EMA, including meetings with the Rapporteur and Co-Rapporteur regarding the planned marketing authorization application, or MAA, and the anticipated timing thereof.

管理層也可能討論公司與歐洲藥品管理局（EMA）的既定互動計畫，包括就擬議的上市許可申請（MAA）與主審（Rapporteur）及共同主審（Co-Rapporteur）會議，以及其預期時程。

In addition, management may discuss the company's ongoing US commercial strategic partnership discussions, its belief that those discussions are in late stages, and expected launch plans and timing. Other forward-looking statements may relate to the potential clinical and economic value proposition of D-PLEX100, the company's preparations for potential commercialization, the potential for 2026 to be a transformative year for PolyPid, and the expectation that current cash resources will be sufficient to fund operations into the second half of 2026 and from several significant upcoming potential milestones.

此外，管理層可能討論公司在美國持續進行的商業策略合作夥伴洽談、公司認為該等洽談已進入後期階段，以及預期的上市計畫與時程。其他前瞻性陳述可能涉及 D-PLEX100 潛在的臨床與經濟價值主張、公司為潛在商業化所做的準備、2026 年可能成為 PolyPid 的轉型之年，以及預期目前現金資源足以支應營運至 2026 年下半年並涵蓋數項即將到來的重要潛在里程碑。

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 the company's Securities and Exchange Commission filings.

前瞻性陳述受多項風險與不確定性影響，其中許多超出公司控制範圍，包括公司不時於向美國證券交易委員會（SEC）提交之文件中所描述的風險。

Accordingly, you should not place undue reliance on these statements. I encourage you to review the company's filings with the SEC, including the company's annual report on Form 20-F filed on February 25, 2026. PolyPid disclaims any intention or obligation, except as required by law, to update or revise any forward-looking statements. This conference call contains time-sensitive information and speaks only as of the live broadcast today, May 13, 2026.

因此，您不應過度依賴這些陳述。我鼓勵您查閱公司向 SEC 提交的文件，包括公司於 2026 年 2 月 25 日提交的 Form 20-F 年度報告。除法律要求外，PolyPid 不承擔更新或修訂任何前瞻性陳述的任何意圖或義務。本次財報電話會議包含具時效性的資訊，僅反映截至今日（2026 年 5 月 13 日）直播時點的情況。

With that, it is my pleasure to turn the call over to Dikla Akselbrad, the CEO of PolyPid. Dikla?

接下來，我很高興把電話交給 PolyPid 執行長 Dikla Akselbrad。Dikla？

Thank you, Yehuda, and thank you all for joining us today. The first quarter of 2026 was a defining transition for PolyPid. We moved from late-stage clinical development to final NDA regulatory submission, our US commercial strategic partnership discussion advanced to what we believe are their late stages, and we continue to build the foundation for what we expect will be a transformative year.

謝謝你，Yehuda，也謝謝各位今天加入我們。2026 年第一季對 PolyPid 而言是一次關鍵性的轉折。我們從後期臨床開發邁向 NDA 最終法規提交；我們在美國的商業策略合作夥伴洽談推進至我們認為的後期階段；同時我們持續奠定基礎，迎接我們預期將是轉型的一年。

Our focus remains on two priorities: advancing D-PLEX100 towards potential FDA approval and finalizing a US strategic partnership that will execute commercial launch in the first quarter of 2027.

我們的重點仍聚焦於兩項優先事項：推進 D-PLEX100 以期獲得 FDA 核准，以及敲定一項美國策略合作夥伴關係，以在 2027 年第一季執行商業上市。

Starting with our regulatory progress. On March 30, 2026, we initiated our NDA submission to the FDA. As a reminder, D-PLEX100 is our lead product candidate for the prevention of surgical site infections, or SSI, in patients undergoing abdominal colorectal surgery.

先談法規進展。2026 年 3 月 30 日，我們啟動向 FDA 提交 NDA。提醒各位，D-PLEX100 是我們的主要產品候選藥物，用於預防接受腹部結直腸手術患者的手術部位感染（SSI）。

With this initial filing, we submitted the CMC and nonclinical modules, as well as other more administrative modules. We expect to submit the remaining components, including the clinical module imminently. This will complete the full NDA submission.

在此次初始申報中，我們提交了 CMC 與非臨床模組，以及其他較偏行政性的模組。我們預期將在近期提交其餘組成部分，包括臨床模組。屆時將完成完整的 NDA 提交。

Once the FDA accepts our submission and given our Fast Track and Breakthrough Therapy Designation, the product is eligible for priority review. If received, this would shorten the standard review period from 10 months to 6 months.

一旦 FDA 受理我們的申請，且鑑於我們已獲快速通道（Fast Track）與突破性療法認定（Breakthrough Therapy Designation），該產品具備優先審查資格。若獲得優先審查，標準審查期可由 10 個月縮短至 6 個月。

In parallel, in March 2026, we received a small business waiver from the FDA for the PDUFA fee. This waiver was approximately $4.3 million, and it allows us to focus our resources on commercialization preparation as we move closer to potential approval.

同時，在 2026 年 3 月，我們獲 FDA 核准小型企業 PDUFA 費用豁免。該豁免約為 430 萬美元，使我們在更接近潛在核准之際，能將資源聚焦於商業化準備。

Turning to Europe. We have scheduled meetings in this quarter with the Rapporteur and Co-Rapporteur, which are the European regulatory authorities designated to lead the assessment of our planned MAA for D-PLEX100. The purpose of these meetings is to align on the content and structure of the submission.

再談歐洲。我們已安排於本季與主審（Rapporteur）及共同主審（Co-Rapporteur）會議；他們是被指定負責主導評估我們擬提交之 D-PLEX100 上市許可申請（MAA）的歐洲監管機關。這些會議的目的在於就申請內容與架構達成一致。

Importantly, the MAA will be submitted to the EMA under the centralized procedure on the basis of therapeutic innovation. The centralized procedures allows the submission of a single marketing application to the EMA that, if approved, enables the product to be marketed in all EU member states. Subject to the outcome of these meetings, we currently plan to submit the MAA in the third quarter of this year.

重要的是，MAA 將以治療創新為基礎，透過集中程序（centralized procedure）向 EMA 提交。集中程序允許向 EMA 提交單一上市申請，若獲核准，產品即可在所有歐盟成員國上市。視上述會議結果而定，我們目前規劃於今年第三季提交 MAA。

On the commercial front, our strategic partnership discussions with potential US partner have continued to progress. We believe they are now in their late stages as the due diligence and evaluation work that defined earlier phases of this discussion is well behind us, and we are currently focused on the active negotiation of definitive agreement terms.

在商業方面，我們與潛在美國合作夥伴的策略合作洽談持續推進。我們認為目前已進入後期階段，因為界定先前階段的盡職調查與評估工作已大致完成，而我們目前正聚焦於具約束力協議條款的積極談判。

Another important area of commercial readiness is our manufacturing and inspection preparations. Once the FDA accepts our NDA submission, the agency is expected to inspect our manufacturing facility. This is a critical step on the path to potential approval, and we are devoting significant resources to these preparations.

商業就緒的另一個重要領域是我們的製造與稽查準備。一旦 FDA 受理我們的 NDA 申請，預期將對我們的製造設施進行查核。這是通往潛在核准路徑上的關鍵一步，我們正投入大量資源進行準備。

We are working closely with experienced external consultants, including industry quality veterans with robust FDA experience who provide us with valuable guidance regarding FDA expectations. We have also conducted multiple mock inspections to ensure our site is ready, the team is prepared, and the FDA inspection passes without any major issues.

我們正與具經驗的外部顧問密切合作，包括擁有豐富 FDA 經驗的產業品質資深專家，他們就 FDA 的期望提供我們寶貴指引。我們也已進行多次模擬稽查，以確保場址就緒、團隊準備充分，並使 FDA 稽查能在沒有任何重大問題的情況下通過。

As a reminder, our facility has already passed four consecutive successful GMP inspections, including the most recent one by the Israeli Ministry of Health. We are entering the FDA inspection process from a position of strength, and we are highly focused on getting it right for first time.

提醒各位，我們的設施已連續通過四次成功的 GMP 稽查，包括最近一次由以色列衛生部進行的稽查。我們以優勢姿態進入 FDA 稽查流程，並高度專注於一次到位、首次就做對。

We have also continued to advance our engagement with the scientific community surrounding the SHIELD II Phase 3 results with two important data presentations this quarter. In early May 2026, at the 45th Annual Meeting of the Surgical Infection Society, we presented an analysis of SHIELD II ASEPSIS score data, a clinical measure of wound infection severity. The results showed a 64% relative risk reduction in patients with an ASEPSIS score greater than 20, which is the threshold for clinically significant wound infection.

本季我們也持續推進與科學界就 SHIELD II 第三期結果的交流，並進行兩項重要數據發表。2026 年 5 月初，在外科感染學會（Surgical Infection Society）第 45 屆年會上，我們發表了 SHIELD II ASEPSIS 分數數據的分析；ASEPSIS 分數是衡量傷口感染嚴重程度的臨床指標。結果顯示，在 ASEPSIS 分數大於 20（即臨床上具顯著意義的傷口感染門檻）的患者中，相對風險降低 64%。

What this tells us is that even among patients in the D-PLEX arm who did experience wound events, severity was meaningfully reduced. Ori will speak in a moment to what this potentially means commercially.

這告訴我們的是，即使在 D-PLEX 組中確實出現傷口事件的患者，其嚴重程度也顯著降低。Ori 稍後將說明這在商業上可能代表的意義。

In April 2026, at the European Society of Clinical Microbiology and Infectious Diseases, also known as ESCMID, we presented new pharmacokinetic or PK data, providing further evidence that D-PLEX100 delivers sustained, controlled release of doxycycline for approximately 30 days. This result in our largest human data set to date support the core mechanistic premise of our technology.

2026 年 4 月，在歐洲臨床微生物學與感染疾病學會（European Society of Clinical Microbiology and Infectious Diseases，亦稱 ESCMID）上，我們發表了新的藥物動力學（PK）數據，進一步證明 D-PLEX100 可在約 30 天內持續、受控地釋放多西環素（doxycycline）。這項迄今最大的人體數據集結果支持我們技術的核心機制假設。

With that, I will now turn the call over to Ori Warshavsky, our Chief Operating Officer, US. Ori?

接下來，我將把電話交給我們的美國營運長 Ori Warshavsky。Ori？

Thank you, Dikla. I would like to spend a few minutes on the broader commercial readiness work underway. Alongside the partnership process and manufacturing readiness, we are continuing with our commercial readiness activities across several other fronts. Picking up on the ASEPSIS data Dikla just referenced, those results have meaningful potential commercial implications.

謝謝你，Dikla。我想用幾分鐘談談目前正在進行的更廣泛商業就緒工作。除了合作夥伴流程與製造就緒之外，我們也在其他多個面向持續推進商業就緒活動。延續 Dikla 剛提到的 ASEPSIS 數據，這些結果在商業上具有重要的潛在意涵。

A 64% relative risk reduction with a P value of 0.0103 in severe wound events translates directly to fewer wound complications, less reliance on intravenous antibiotics, the potential for earlier hospital discharge and lower hospital resource utilization.

在嚴重傷口事件方面，相對風險降低 64%，且 P 值為 0.0103，這可直接轉化為更少的傷口併發症、更少依賴靜脈注射抗生素、可能更早出院，以及更低的醫院資源使用。

That is exactly the language hospital P&T committees and payers respond to, and we believe that this is central to the health economics work we are now accelerating. Alongside this, we are expanding our presence at major surgical and infectious disease conferences, advancing additional planned scientific publications and continuing to engage leading clinical voices in the field.

這正是醫院 P&T（藥事與治療）委員會與付款方會回應的語言，我們相信這也是我們目前正在加速推進的健康經濟學工作之核心。與此同時，我們正在擴大在主要外科與感染性疾病會議上的能見度，推進其他已規劃的科學論文發表，並持續與該領域的臨床意見領袖保持互動。

As part of these efforts, we hosted a roundtable discussion with KOLs earlier this month at the Surgical Infection Society annual meeting, which was chaired by the president of the society. There were a lot of good insights during that meeting, including an open discussion on the fact that infection rates are often underreported to avoid penalties and that growing obesity rates are impacting infection rates in abdominal surgeries.

作為這些努力的一部分，我們本月稍早在外科感染學會（Surgical Infection Society）年會上與 KOL 舉辦了一場圓桌討論，並由該學會會長主持。會中有許多寶貴洞見，包括公開討論到：為了避免罰則，感染率往往被低報；以及肥胖率上升正在影響腹部手術的感染率。

At the general assembly of the conference, there was a call from the stage to see how the society can, and I quote, help move practice forward with a really novel product. Together, these efforts build the awareness and the evidence base that will support a successful launch.

在大會全體會議上，台上有人呼籲探討該學會如何——我引用原話——以一項真正新穎的產品來協助推動臨床實務向前發展。這些努力共同提升市場認知並建立證據基礎，將支持成功上市。

I would also like to briefly address the broader environment in which D-PLEX100 would be launched. Two converging trends are shaping that environment in important ways. The first is the growing focus across US hospital systems on infection prevention, antimicrobial stewardship and reducing the use of systemic antibiotics.

我也想簡要談談 D-PLEX100 上市時所處的更廣泛環境。有兩股匯聚的趨勢正在以重要方式塑造該環境。第一個是美國各大醫院體系日益聚焦於感染預防、抗菌藥物管理（antimicrobial stewardship）以及降低全身性抗生素的使用。

The second is the evolving reimbursement landscape. Under Medicare's new Transforming Episode Accountability Model, known as TEAM, hospitals are now financially accountable for inpatient and outpatient complications occurring throughout the 30 days following certain surgical procedures, including colorectal surgery.

第二個是報銷（reimbursement）環境的演變。在 Medicare 新的「轉型式療程責任模型」（Transforming Episode Accountability Model，簡稱 TEAM）之下，醫院如今需對特定手術（包括大腸直腸手術）後 30 天內住院與門診期間發生的併發症承擔財務責任。

This represents a significant shift as the 30-day window for SSI is no longer just a clinical concern; it is increasingly tied to how hospitals are reimbursed. We believe D-PLEX100 is well-aligned with both trends. By delivering high concentration of broad-spectrum antibiotic directly at the surgical site rather than relying on systemic antibiotic load, D-PLEX100 supports the same antimicrobial stewardship goals hospital systems are increasingly being asked to advance.

這代表一項重大轉變，因為 SSI 的 30 天觀察窗口不再只是臨床上的關切；它也日益與醫院如何獲得報銷掛鉤。我們相信 D-PLEX100 與這兩項趨勢高度一致。D-PLEX100 透過在手術部位直接提供高濃度廣效抗生素，而非依賴全身性抗生素負荷，支持醫院體系日益被要求推進的同一套抗菌藥物管理目標。

Just as important, D-PLEX100 is designed to provide antibiotic protection for approximately 30 days, the same window which hospitals are now financially accountable for. We expect this convergence, clinical data on one side, policy-driven economic incentives on the other to be an increasingly important part of D-PLEX's position with hospital system and payers as we move towards potential commercialization.

同樣重要的是，D-PLEX100 的設計可提供約 30 天的抗生素保護，正好對應醫院目前需承擔財務責任的同一時間窗口。我們預期這種匯聚——一端是臨床數據，另一端是政策驅動的經濟誘因——將在我們邁向潛在商業化之際，成為 D-PLEX 與醫院體系及付款方溝通定位時愈發重要的一部分。

With that, I will now turn the call over to Jonny to review our financial performance for the quarter. Jonny?

接下來，我將把電話會議交給 Jonny，請他回顧我們本季的財務表現。Jonny？

Thank you, Ori. I will now walk through our financial results for the first quarter ended March 31, 2026. Starting with operating expenses, research and development expenses for the first quarter of 2026 were $5.8 million compared to $6.1 million in the first quarter of 2025.

謝謝你，Ori。接下來我將說明截至 2026 年 3 月 31 日止第一季的財務結果。先從營業費用開始，2026 年第一季研發費用為 580 萬美元，較 2025 年第一季的 610 萬美元下降。

This decrease primarily reflects the completion of the SHIELD II Phase 3 trial and our ongoing transition towards regulatory submission and commercial readiness activities. General and administrative expenses for the quarter were $1.6 million compared to $1.2 million for the same period in 2025.

此一下降主要反映 SHIELD II 第三期試驗已完成，以及我們持續轉向法規申報與商業化準備相關活動。本季一般及行政費用為 160 萬美元，較 2025 年同期的 120 萬美元增加。

Marketing and business development expenses were $0.4 million compared to $0.3 million in the prior year period. Net loss for the first quarter of 2026 was $7.7 million or $0.35 per share compared to a net loss of $8.3 million or $0.70 per share in the first quarter of 2025.

行銷與業務開發費用為 40 萬美元，較去年同期的 30 萬美元增加。2026 年第一季淨損為 770 萬美元（每股 0.35 美元），相較之下，2025 年第一季淨損為 830 萬美元（每股 0.70 美元）。

Turning to the balance sheet, as of March 31, 2026, PolyPid had $10.9 million in cash, cash equivalents, and short-term deposits compared to $12.9 million on December 31, 2025. The modest decrease approximately $2 million reflects continued operating activities, partially offset by proceeds from warrant exercises during the quarter.

再看資產負債表，截至 2026 年 3 月 31 日，PolyPid 的現金、約當現金與短期存款為 1,090 萬美元，較 2025 年 12 月 31 日的 1,290 萬美元下降。約 200 萬美元的小幅下降反映持續的營運活動支出，部分由本季權證行使所得款項所抵銷。

Subsequent to quarter end, our balance sheet has been further strengthened by an additional development. In early May 2026, we completed the full repayment of our remaining loan facility originally entered into in April 2022.

在季後，我們的資產負債表又因另一項進展而進一步強化。2026 年 5 月初，我們完成了對剩餘貸款額度的全額償還，該貸款最初於 2022 年 4 月簽訂。

As a result, the company has fully repaid its outstanding debt obligations and has no remaining loan-related liabilities as of the date of today's earnings release, further strengthening our balance sheet ahead of potential commercialization.

因此，截至今日財報新聞稿發布之日，公司已全數償還未清償的債務義務，且不再有任何與貸款相關的負債，這在潛在商業化之前進一步強化了我們的資產負債表。

Based on our current plans and assumptions, we believe that our existing cash resources will be sufficient to fund operations into the second half of 2026 and through several significant upcoming potential milestones.

基於我們目前的計畫與假設，我們相信現有現金資源足以支應營運至 2026 年下半年，並支撐數個即將到來的重要潛在里程碑。

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

接下來，我們將開放提問。接線員？

(Operator Instructions) Chase Knickerbocker, Craig-Hallum.

（接線員指示）Chase Knickerbocker，Craig-Hallum。

Good morning. Thanks for taking the questions. Maybe just to start, a couple on the filing. Just as we think about that CMC module, maybe talk about the work that you've done with consultants internally to submit that module with confidence, I think, particularly around the process validation portions with your differentiated drug product, which obviously also comes with some novel aspects being that it is differentiated, right? So maybe just speak to the work you've done with consultants and the confidence you've gained there.

早安。謝謝讓我提問。我先從申報（filing）相關的問題開始，可能有兩個。談到那個 CMC 模組時，能否談談你們與顧問及內部團隊所做的工作，讓你們能有信心提交該模組？我想特別是針對你們具差異化的藥品在製程驗證（process validation）部分，因為它顯然也有一些新穎之處，畢竟它是差異化的，對吧？所以能否談談你們與顧問合作所做的工作，以及因此建立的信心。

And then secondly, I'll just ask both upfront. As you think about the inspection readiness, you had several mock audits at this point. Maybe just talk to us a little bit about how those have progressed, how your findings from those have progressed and again, increase your confidence in the positioning of your filing. Thank you.

第二個我也先一起問：談到迎檢準備（inspection readiness），你們目前已做過數次模擬稽核（mock audits）。能否再多談一些這些稽核的進展、從中發現事項的改善進展，以及這如何再次提升你們對申報定位的信心？謝謝。

Thank you, Chase. Good morning. So I'll start with the first portion on the CMC. Obviously, there is the aspect of consultants and regulatory consultant. But I think the most reassuring portion here is that we took advantage of -- or we used the Breakthrough Therapy Designation, which allows us to have more frequent communication with the FDA.

謝謝你，Chase。早安。我先從 CMC 的第一部分開始。當然，這裡有顧問以及法規顧問的面向。但我認為最令人安心的一點是，我們善用——或者說我們運用了——突破性療法認定（Breakthrough Therapy Designation），這讓我們能與 FDA 更頻繁地溝通。

And we really communicate prior to submission the NDA with the FDA on different processes on different methods as well as submitting the development report and everything that we thought could be risky, and we wanted the agency feedback ahead of submitting an NDA, we did that.

我們在提交 NDA 之前，就不同流程、不同方法與 FDA 充分溝通，同時提交開發報告；凡是我們認為可能有風險、希望在提交 NDA 前先取得主管機關回饋的事項，我們都這麼做了。

So yes, there is a portion of getting advised and reviews, and we have a very experienced team in the CMC aspect from the development stage up to the actual operational aspect. But we also used -- communicate with the FDA multiple times to make sure that we are aligned with what they are expecting to see. So that's on the module -- the CMC module.

所以，是的，確實有一部分是取得建議與審閱；而且我們在 CMC 面向有一支非常有經驗的團隊，從開發階段一路到實際營運執行。但我們也——多次與 FDA 溝通，以確保我們與他們期望看到的內容一致。以上是關於該模組——CMC 模組。

On the preparation for the inspection, there are a couple of things that I think we've done from the start. The first one being the fact that we have built our own manufacturing facility. So it's not a CMO. We have full control of the processes on the method, regulation, all the implementation methods internally, both in terms of our employees as well as our QA. It's all internal. And that's, I think, a good thing and strengthen our position.

至於迎接稽查的準備，我認為我們從一開始就做了幾件事。第一是我們建立了自有製造工廠，所以不是委託 CMO。我們對流程、方法、法規以及所有內部執行方式都有完全的掌控，無論是員工端或 QA 端，全部都在內部。我認為這是一件好事，也強化了我們的立場。

The other thing is really working from day one with the eyes to the FDA expectation, always staying up to date to see what is the FDA expectation, what is the most recent expectation -- and this is why we were able to pass this inspection, which are also, by the way, qualified for the European authorities. So that's an ongoing.

另一點是從第一天起就以符合 FDA 期望為目標來運作，隨時保持更新，了解 FDA 的期望是什麼、最新的期望是什麼——這也是為什麼我們能通過這次稽查；順帶一提，該稽查也符合歐洲主管機關的要求。所以這是一項持續進行的工作。

And now as we get closer to the pre-approval inspection, obviously, we are even tightening those processes, even tightening what is needed, working with very veteran quality person that really been on almost on a weekly basis part of FDA inspection, so we could really know what the FDA is focusing on these days.

而現在，隨著我們更接近核准前稽查（pre-approval inspection），我們顯然會進一步收緊這些流程、收緊所需事項，並與一位資深的品質專家合作；他幾乎每週都參與 FDA 稽查的一部分，因此我們能真正掌握 FDA 近來關注的重點。

Now you were asking about specifically if anything came out of this mock inspection that can put this in danger. I'm very freely, I can say that we don't think so that obviously, there is -- when there is an inspection, there are comments, there are suggestions, there are reviews, but all of it is things that either have already been implemented and corrected or things that are on the go to that, but nothing that we viewed as major. And also the -- for the matter of the Israeli Ministry of Health did not see those as major or critical.

你特別問到，這次模擬稽查是否有任何結果可能讓事情陷入風險。我可以很坦率地說，我們不這麼認為。當然，稽查時會有意見、建議與審閱，但這些要麼已經完成導入與修正，要麼正在進行中，但沒有任何我們視為重大的事項。此外——就以色列衛生部而言，他們也不認為那些是重大或關鍵問題。

Very helpful. Thank you.

非常有幫助。謝謝。

Thank you.

謝謝。

Jason Butler, Citizens JMP.

Jason Butler，Citizens JMP。

Hi. Thanks for taking the question. First one for me. Just can you speak to any dialogue that you've had with FDA since submitting the first modules of the NDA? Have you had any questions or information requests from FDA yet?

嗨。謝謝讓我提問。第一個問題。想請教自從提交 NDA 的第一批模組以來，你們與 FDA 之間是否有任何溝通？FDA 是否已提出任何問題或資訊補充要求？

So as we showed previously, again, so not something formal, nothing formal at this stage, but we've not completed the NDA submission. So we don't really expect to get anything. But the NDA submission is -- or the completion is expected imminently. So I'm sure we'll start to get that immediately after.

如同我們先前所展示的，再次強調，現階段沒有任何正式的（溝通），沒有任何正式的事項，因為我們尚未完成 NDA 的提交。因此我們也不太預期會收到任何回覆。不過 NDA 的提交——或說完成——預計很快就會完成。所以我相信在那之後我們會立刻開始收到相關訊息。

Great. And then you've spoken in the past about what you're looking for from a commercial partnership or collaboration. Can you just speak to -- as you continue those discussions, have those priorities shifted at all? Or are your goals the same out of any partnership? Thank you.

很好。接著你們過去談過在商業合作或協作中希望獲得什麼。能否談談——隨著你們持續推進這些討論，你們的優先事項是否有任何改變？或你們對任何合作的目標仍然相同？謝謝。

So no, they have not shifted. We are still focused and we think that the main objective is to have a partner with good presence in the hospital and capabilities to build and expand on a sales force that is in the hospital. That's what we are looking at. And we're very pleased so far.

沒有，並沒有改變。我們仍然聚焦於、也認為主要目標是找到一個在醫院端有良好佈局、並具備建立與擴充醫院銷售團隊能力的合作夥伴。這就是我們在尋找的方向。而且到目前為止我們非常滿意。

Great. Thanks for taking our questions.

很好。謝謝回答我們的問題。

Thank you, Jason.

謝謝你，Jason。

Boobalan Pachaiyappan, ROTH Capital Partners.

Boobalan Pachaiyappan，ROTH Capital Partners。

Hi. Good morning and thanks for taking our questions. A couple from us. Maybe to start with, I was wondering if you could talk about the tariff rate for drugs that are manufactured in Israel and commercialized in the US and other countries. Is it like a flat tariff rate regardless of indications? Any color on that, please?

嗨。早安，謝謝讓我們提問。我們有幾個問題。先從第一個開始，我想請你談談在以色列製造、並在美國及其他國家商業化的藥品，其關稅稅率如何？是否不論適應症都採固定稅率？能否提供一些說明？

Ori, do you want to take this one regarding the US?

Ori，你要不要就美國這部分回答？

Yes. So the question -- just so I understand the question is regarding tariffs on products from Israel to the US.

好的。所以這個問題——我確認一下我是否理解正確——是關於從以色列輸往美國的產品關稅。

Yes, for drug products that are manufactured in Israel and commercialized in the US and other countries.

是的，針對在以色列製造、並在美國及其他國家商業化的藥品。

That's a good question. As far as I know, and we can follow up on this later, there's a flat tariff rate pre-negotiated between the government of the US and Israel on all incoming goods coming from Israel to the US. We can follow up on this with the rates.

這是個好問題。就我所知——我們之後也可以再跟進確認——美國政府與以色列之間對所有自以色列輸入美國的貨品，有一個事先談妥的固定關稅稅率。我們可以再跟進具體稅率。

All right. Thank you. That's helpful. And in light of the ongoing conflict in the Middle East area region, can you maybe talk about the timeline or the impact of this conflict on the inspection procedure to be conducted by the FDA? How are you thinking about it? And if you expect the inspection timeline to be -- is there -- at what point do you think you will have more clarity on whether or not the inspection will take place in second half of '26?

好的，謝謝。這很有幫助。考量到中東地區持續的衝突，你們能否談談這場衝突對 FDA 將進行的查廠程序之時程或影響？你們如何看待？以及你們預期何時能更清楚知道查廠是否會在 2026 年下半年進行？

So thank you for this question, Boobalan. Obviously, if we knew this answer, we would have been -- we could use it in many, many other aspects. But seriously, we know that the FDA was inspecting two facilities in Israel this last March. Obviously, since March, they were not here. We do not expect this to have an effect.

謝謝這個問題，Boobalan。顯然，如果我們知道答案，我們——也能把它用在很多很多其他面向。不過認真說，我們知道 FDA 在今年 3 月曾在以色列查核兩個設施。顯然自 3 月以來，他們沒有再來。我們不預期這會造成影響。

The FDA has many means to inspect the facility, either from -- COVID was here two years almost and drugs were approved. So I think both companies and the agency find ways to get drugs approved. So we do not expect it to change anything. We are operating in a normal course of business. You can see both in terms of the timeline, we were committed to submitting the NDA before the end of the first quarter, which was done.

FDA 有很多方式可以查核設施；例如——COVID 幾乎持續了兩年，藥物仍然獲得核准。所以我認為公司與主管機關都能找到方法讓藥物獲批。因此我們不預期會改變任何事情。我們仍以正常營運方式推進。你也可以看到，就時程而言，我們承諾在第一季結束前提交 NDA，而這已完成。

We are now very shortly, we'll finalize this submission. And the team here is fully committed to all of these processes. And on a personal note, I hope that it will come and there won't be any issues.

我們現在很快就會完成這次提交。這裡的團隊也完全投入所有流程。就我個人而言，我希望一切順利、不會有任何問題。

All right. Maybe one last one. I understand D-PLEX100 will be commercialized by the strategic partner. So just curious, I mean, do you still need to hire some employees to internally track the progress? And can you also talk about the impact of this on G&A spend? Thank you. That's all.

好的。最後一個問題。我理解 D-PLEX100 將由策略合作夥伴進行商業化。所以我想了解，你們是否仍需要在內部聘用一些員工來追蹤進度？也請談談這對 G&A 費用的影響。謝謝。以上。

So I'll let Jonny add on that. But specifically on G&A, I don't see any major impact. We do think that there will be some increase later on as we expand the commercialization and sales increase, we'll need more employees on the operational front, obviously. And once we can discuss more freely on next step, we will also lay out the development plan as we see it.

我先請 Jonny 補充。不過就 G&A 而言，我看不出會有任何重大影響。我們確實認為，隨著後續商業化擴張、銷售增加，營運端顯然會需要更多員工，因此之後會有一些增加。而一旦我們能更自由地討論下一步，我們也會提出我們所看到的開發計畫。

No, I agree. So for the whole G&A part, we wouldn't expect such a big increase, but there will be some increase. And as Dikla said, the bigger increase will be in the operational part.

是的，我同意。就整體 G&A 來說，我們不預期會有很大的增加，但會有一些增加。如 Dikla 所說，更大的增幅會在營運端。

All right. Thank you.

好的，謝謝。

(Operator Instructions) Brandon Folkes, H.C. Wainwright.

（接線員指示）Brandon Folkes，H.C. Wainwright。

Hi. Thanks for taking my questions and congrats on the progress. Maybe just two for me. Can you talk about how broad of a development pipeline you would consider once you do execute on a commercial transaction? Are you envisioning a singular product development focus going forward? Or could we see a pretty broad pipeline?

嗨。謝謝讓我提問，也恭喜進展。大概兩個問題。你能談談一旦你們完成商業交易後，你們會考慮多廣的開發產品線嗎？你們是否設想未來會聚焦於單一產品的開發？還是我們可能會看到相當廣泛的產品線？

And then secondly, you remain very disciplined on the SG&A line. So can you just talk about if you envision PolyPid itself doing any market awareness this year ahead of an approval and ahead of a potential partnership? Thank you.

第二，你們在 SG&A 費用上一直非常自律。能否談談你們是否設想 PolyPid 今年在核准前、以及潛在合作夥伴關係建立前，會自行進行任何市場教育／市場認知活動？謝謝。

Thank you. Thank you, Brandon. So I'll start with the first portion of your question. In terms of -- or maybe let's start with the latter. We do see PolyPid doing some prelaunch activities.

謝謝。謝謝你，Brandon。我先回答你問題的第一部分。關於——或者我們先從後半段開始。我們確實會看到 PolyPid 進行一些上市前活動。

Everything that was done up until now was done by us, whether it is around packaging names, scientific conference, all of that is done with us, and we'll see some of it also continues. We are hoping to publish the manuscript of the SHIELD I -- the SHIELD II data in a peer-reviewed journal soon. All of this is the more scientific clinical assets are managed by us and we'll be able to again say more how much of it will be managed by us or the partner.

截至目前為止所做的一切都是由我們完成的，不論是包裝命名、科學會議等，全部都是我們在做，我們也會看到其中一部分會持續進行。我們希望能在近期將 SHIELD I——SHIELD II 的數據論文發表在同儕審查期刊上。所有這些較偏科學與臨床的資產都由我們管理；至於未來有多少會由我們或合作夥伴管理，我們也會再更清楚地說明。

On other geographies, it's to be seen depending on the arrangement that we will get to. But generally, for D-PLEX, we do not see ourselves marketing the product on our own.

至於其他地理區域，將視我們最終達成的安排而定。但整體而言，對於 D-PLEX，我們不認為會由我們自行行銷該產品。

In terms of our pipeline, this is a very important question. We envision the pipeline, and this is work that is done already and some of those are communicated to investors, but I think once we have a partner that could be even further reassessed and strengthened, we envision three paths.

關於我們的產品線，這是非常重要的問題。我們對產品線的構想——這些工作其實已經在進行，其中一些也已向投資人溝通——但我認為一旦我們有了合作夥伴，還可以進一步重新評估並強化。我們設想有三條路徑。

One is obviously -- and this was discussed quite intensively expanding D-PLEX behind abdominal indication. There is a high need in many other surgeries, and this will be done with the partner. The other is expanding our PLEX platform to other indications. And we also have our younger program in the metabolic health. So I envision and we envision multiple products that some are late stage and some are more early stage.

第一條顯然是——而且我們已相當深入地討論——將 D-PLEX 擴展到腹部適應症之外。許多其他手術領域都有高度需求，而這將與合作夥伴一起推進。第二條是將我們的 PLEX 平台擴展到其他適應症。此外，我們也有較早期的代謝健康（metabolic health）計畫。因此我認為、我們也認為會有多個產品，其中一些屬於後期階段，一些則較早期。

Great. Thanks so much.

很好。非常感謝。

Thank you.

謝謝。

Thank you. There seems to be no further questions. I will now hand the call back to Dikla for closing remarks.

謝謝。看起來沒有進一步的問題。我現在把電話交回給 Dikla 作結語。

Thank you all for joining us today. The first quarter of 2026 marked a critical transition for PolyPid. Our rolling NDA submission is well underway with completion expected imminently. Our US strategic partnership discussions are in their late stages.

謝謝各位今天加入我們。2026 年第一季對 PolyPid 而言標誌著一個關鍵的轉折。我們的滾動式 NDA 提交正在順利進行，預計很快就會完成。我們在美國的策略合作夥伴討論也已進入後期階段。

Our European regulatory strategy is advancing toward an MAA submission later this year, and our balance sheet has been meaningfully strengthened.

我們的歐洲法規策略正推進，目標是在今年稍晚提交 MAA，同時我們的資產負債表也已顯著強化。

Together, these milestones mark what we believe is the most consequential phase in our company's history. We continue to believe that 2026 has the potential to be a transformative year for PolyPid, and we look forward to providing further updates as these milestones unfold. Thank you.

我們認為，這些里程碑共同標誌著公司歷史上最具關鍵性的階段。我們仍然相信 2026 年有潛力成為 PolyPid 的轉型之年，並期待在這些里程碑逐步展開時，提供更多更新。謝謝。

Operator, you may now close the call.

接線員，你現在可以結束電話會議。

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。感謝各位參與。您現在可以中斷連線。