PolyPid Ltd (PYPD) 2023 Q4 法說會逐字稿

完整原文

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  • Brian Ritchie - IR

    Brian Ritchie - IR

  • Thank you all for participating in PolyPid fourth quarter and full year 2023 earnings conference call. Joining me on the call today will be Dikla Czaczkes Akselbrad, Chief Executive Officer; PolyPid, Jonny Missulawin, PolyPid, Chief Financial Officer; and Ori Warshavsky, Chief Operating Officer of PolyPid.

    感謝大家參加 PolyPid 2023 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是執行長 Dikla Czaczkes Akselbrad; PolyPid,Jonny Missulawin,PolyPid,財務長;和 PolyPid 營運長 Ori Warshavsky。

  • Earlier today, PolyPid released financial results for the 3-months and 12-months ended December 31, 2023. A copy of the press release is available in the Investors section on the company's website, www.polypid.com.

    今天早些時候,PolyPid 發布了截至 2023 年 12 月 31 日的 3 個月和 12 個月的財務業績。新聞稿的副本可在公司網站 www.polypid.com 的投資者部分取得。

  • I'd like to remind you that on this call, management will make forward-looking statements within the meaning of the Federal Securities Laws, for example, management is making forward-looking statements when it discusses the expected timing for recruitment and top-line results from the SHIELD II trial and of the unblinded interim analysis, the planned new drug application submission for D-PLEX100.

    我想提醒您,在這次電話會議上,管理層將做出聯邦證券法含義內的前瞻性陳述,例如,管理層在討論招聘和營收的預期時間時會做出前瞻性陳述SHIELD II 試驗和非盲中期分析的結果,以及計畫提交的D-PLEX100 新藥申請。

  • The potential impacts and uses for OncoPLEX and the PLEX platform, the company's expected cash runway and the potential to receive additional funds if warrants are exercised.

    OncoPLEX 和 PLEX 平台的潛在影響和用途、公司預期的現金跑道以及在行使認股權證時獲得額外資金的潛力。

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

    前瞻性陳述受到眾多風險和不確定性的影響,其中許多風險和不確定性超出了我們的控制範圍,包括我們在 SEC 備案文件中不時描述的風險。我們的結果可能與這些預測有重大差異。這些陳述涉及重大風險和不確定性,可能導致實際結果或事件出現重大差異。

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

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

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

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

  • This conference call contains time-sensitive information and speaks only as of the live broadcast today, February 14, 2024. With the completion of these prepared remarks, it is my pleasure to turn the call over to Dikla Czaczkes Akselbrad, CEO of PolyPid. Dikla?

    本次電話會議包含時效性訊息,僅在今天(2024 年 2 月 14 日)直播時發言。在完成這些準備好的發言後,我很高興將電話轉給 PolyPid 執行長 Dikla Czaczkes Akselbrad。迪克拉?

  • Dikla Czaczkes Akselbrad - CEO

    Dikla Czaczkes Akselbrad - CEO

  • Thank you Brian. On behalf of our team at PolyPid, I would like to welcome everyone, including our new shareholders to our fourth quarter and full year 2023 earnings call. We are thrilled with the significant progress recently achieved throughout our business as we expected. Enrollment in our ongoing SHIELD II pivotal trial for D-PLEX100, for the prevention of abdominal colorectal surgical site infection has begun to ramp up.

    謝謝布萊恩。我謹代表 PolyPid 團隊歡迎所有人,包括我們的新股東參加我們的第四季和 2023 年全年財報電話會議。正如我們預期的那樣,我們的業務最近取得了重大進展,我們對此感到非常興奮。我們正在進行的用於預防腹部結直腸手術部位感染的 D-PLEX100 SHIELD II 關鍵試驗的註冊人數已開始增加。

  • We have also generated some new, highly compelling preclinical data with OncoPLEX that demonstrates its potential in oncology. More of this in order to support our robust clinical development efforts, we successfully completed a $16 million financing that included participation from multiple new US life sciences focused investors.

    我們也利用 OncoPLEX 產生了一些新的、非常引人注目的臨床前數據,證明了其在腫瘤學方面的潛力。為了支持我們穩健的臨床開發工作,我們成功完成了 1,600 萬美元的融資,其中包括多個專注於美國生命科學的新投資者的參與。

  • I will discuss all of this in greater detail shortly, but let's begin with the status of SHIELD II. The study has now enrolled more than 100 subjects and approximately 40 centers are currently open. As a reminder, we intend to conduct an unblinded interim analysis once approximately 400 patients of the planned total of 600 subjects complete the 30 days follow-up, which is expected to occur in mid-2024, top line results are anticipated in the second half of this year.

    我很快就會更詳細地討論所有這些,但讓我們從 SHIELD II 的狀態開始。該研究現已招募了 100 多名受試者,目前約有 40 個中心正在開放。提醒一下,一旦計劃的 600 名受試者中的約 400 名患者完成 30 天的隨訪(預計在 2024 年中期進行),我們打算進行非盲中期分析,預計下半年會出現頂線結果今年的。

  • Which respect to the expected recruitment rate, as we said on our last call, once the site is fully up and running, which takes several weeks following it's being formally open. We anticipate approximately 1.5 patients being recruited into the trial per center per month, and we expect to have overall approximately 60 centers opened and recruiting patients.

    正如我們在上次電話會議中所說,一旦網站完全啟動並運行(正式開放後需要幾週時間),這就是預期的招聘率。我們預計每個中心每月約招募 1.5 名患者參與試驗,預計總共開設約 60 個中心並招募患者。

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

    繼續重申我們之前所說的,去年我們在美國提交 D-PLEX100 的潛在 NDA 申請有明確的監管途徑,FDA 承認,不僅 SHIELD I 結果可能提供安全性和有效性的支持性證據。D-PLEX100 在大手術切口患者中的療效,也證實了它的成功,應該足以支持潛在的NDA 提交。

  • We continue to strongly believe that SHIELD II is a de-risked Phase 3 trial giving more focused patient populations in which we have already generated highly positive data and showed one and the fact that it will not be conducted within the tight COVID-related restrictions that were in place during the pandemic and throughout the duration of shared one, we are also leveraging key learnings from should one related to the sites involved in the study.

    我們仍然堅信,SHIELD II 是一項去風險的3 期試驗,可提供更集中的患者群體,其中我們已經產生了高度積極的數據,並顯示了一個事實,即它不會在與新冠病毒相關的嚴格限制內進行,在大流行期間以及整個共享研究期間,我們也利用了與參與研究的網站相關的重要經驗教訓。

  • While we are targeting approximately 60 centers, for SHIELD II around the same numbers SHIELD I, we now have firm knowledge of the best performing sites from SHIELD I in terms of recruitment, patient monitoring and good clinical practice. We believe this to be essential in the execution of SHIELD II.

    雖然我們的目標是大約 60 個中心,而 SHIELD II 的中心數量與 SHIELD I 的數量大致相同,但我們現在已經充分了解 SHIELD I 在招募、患者監測和良好臨床實踐方面表現最佳的中心。我們相信這對《神盾局 II》的執行至關重要。

  • We have also enhanced our clinical operations team, another key step towards supporting a successful study moving on. I'm excited to report today some new preclinical data generated with our OncoPLEX product candidate.

    我們也增強了我們的臨床操作團隊,這是支持成功研究的另一個關鍵步驟。我今天很高興向大家報告我們的 OncoPLEX 候選產品產生的一些新的臨床前數據。

  • We have recently demonstrated the ability of OncoPLEX to be injected into a tumor early while having effective and prolonged antitumor impact, a single intravitreal injection of OncoPLEX, significantly reduced tumor growth and increased survival in two well-established and commonly used tumor animal models murine melanoma and murine colon carcinoma..

    我們最近證明了OncoPLEX 能夠早期注射到腫瘤中,同時具有有效且持久的抗腫瘤作用,在兩種成熟且常用的小鼠黑色素瘤動物模型中,單次玻璃體內注射OncoPLEX 即可顯著減少腫瘤生長並提高生存率和小鼠結腸癌..

  • OncoPLEX has now shown efficacy in all models. It has been tested and across the various therapeutic approaches either is a nail adjuvant via intratumoral injection or is an adjuvant via post resection application in the tumor bed.

    OncoPLEX 現已在所有模型中顯示出功效。它已經過各種治療方法的測試,要么是通過腫瘤內注射的指甲佐劑,要么是通過切除後應用於腫瘤床的佐劑。

  • To date on complexes being tested in six different models and applications all with highly effective results. The effect of OncoPLEX is attributable to the PLEX technology's unique mechanism of action that allows constant and prolonged release of chemotherapeutic drug dose not exhale.

    迄今為止,複合物已在六種不同的模型和應用中進行了測試,均取得了高效的結果。OncoPLEX 的效果歸因於 PLEX 技術獨特的作用機制,可以持續、長時間地釋放化療藥物而不是呼氣。

  • The locality combined with the prolonged and constant release rate can promote deep penetration of the drug into the tumor with minimal systemic exposure to the chemotherapeutic agent. The intratumoral injection of the PLEX platform could enable it to be used as an interventional oncology treatment, not only with PLEX, but also with additional chemotherapeutics, all other types of molecules such as antibodies, bispecific and nucleic acid.

    局部性與延長且恆定的釋放速率相結合可以促進藥物深入滲透到腫瘤中,同時使化療藥物的全身暴露最小化。PLEX 平台的腫瘤內注射使其能夠用作介入性腫瘤治療,不僅可以使用 PLEX,還可以使用其他化療藥物、所有其他類型的分子,例如抗體、雙特異性分子和核酸。

  • Shifting gears, we were pleased to recently significantly protify our balance sheet by successfully closing a private placement financing all PIPE for $16 million of gross proceeds. The pipe syndicate was comprised of new and existing investors, including participation from US life science, focused investors, DAFNA Capital Management and Rosalind Advisors, produce to the PIPE they invested purchased 3,371,312 of the company's ordinary share.

    我們很高興最近成功完成了私募融資,為所有 PIPE 提供了 1600 萬美元的總收益,從而顯著提高了我們的資產負債表盈利。該管道財團由新舊投資者組成,其中包括美國生命科學重點投資者、DAFNA Capital Management 和 Rosalind Advisors 的參與,他們投資的 PIPE 購買了 3,371,312 股該公司的普通股。

  • All pre-funded words in lien notes at a purchase price of $4.81 per share for gross proceeds of $16 million and received warrants to purchase up to the same amount of shares of common stock with an exercise price of $5.5 per share for a total exercise price of $19 million. It was expired upon the earlier of two years from the date of issuance and 10 trading days following PolyPid announcement of a positive recommendation by the Data Safety Monitoring Board regarding the company's unblinded interim analysis in SHIELD II Phase 3 trial of D-PLEX100 resulting in the stopping of the trial due to positive signals.

    留置權票據中的所有預先融資字詞均以每股4.81 美元的購買價獲得,總收益為1600 萬美元,並獲得了購買最多相同數量普通股的認股權證,行使價為每股5.5 美元,總行使價為5.5 美元1900萬美元。該期限自發行之日起兩年和PolyPid 宣布資料安全監測委員會就該公司在D-PLEX100 的SHIELD II 第3 階段試驗中的非盲中期分析提出積極建議後10 個交易日(以較早者為準)後到期,該建議導致由於積極信號而停止試驗。

  • The initial $16 million extended our cash runway until late in the third quarters of 2024 and behind the anticipated timing of SHIELD II planned unblinded interim analysis, it's the result of the unblinded interim analysis are positive and all warrants issued in the financing are exercised. The additional $19 million would fund PolyPid to the start of a planned new drug application submission for D-PLEX100

    最初的1600 萬美元將我們的現金跑道延長到2024 年第三季末,而在SHIELD II 計劃的非盲中期分析的預期時間背後,是非盲中期分析的結果是積極的,並且融資中發行的所有認股權證都被行使了。額外的 1900 萬美元將資助 PolyPid 啟動 D-PLEX100 計劃的新藥申請提交

  • I'd like to take the opportunity to thank all of the investors who participated in this financing for their confidence and support. With that it is my pleasure to turn the call over to Jonny. Jonny?

    藉此機會,感謝所有參與本次融資的投資者的信任與支持。我很高興將電話轉給喬尼。喬尼?

  • Jonny Missulawin - CFO

    Jonny Missulawin - CFO

  • Thank you, Dikla. As of December 31, 2023, the company had cash and short-term deposits of $5.3 million as compared to $12.6 million at the end of 2022. This does not include the net proceeds of approximately $15 million generated from the PIPE financing closed in January 2024. As Dikla noted, we expect that our performer cash balance will be sufficient to fund operations into late third quarter 2024.

    謝謝你,迪克拉。截至 2023 年 12 月 31 日,該公司的現金和短期存款為 530 萬美元,而 2022 年底為 1,260 萬美元。這不包括 2024 年 1 月完成的 PIPE 融資產生的約 1,500 萬美元的淨收益。正如 Dikla 指出的那樣,我們預計我們的表演者現金餘額將足以為 2024 年第三季末的營運提供資金。

  • Now let's turn to our income statement. Research and Development expenses for the three-months ended December 31, 2023, for $4.6 million compared to$ 4.7 million in the same three-month period of 2022. R&D expenses in the most recently completed fourth quarter were driven by the ramp-up of the ongoing SHIELD II Phase 3 trial for the full year ended December 31, 2023, and 2022. R&D expenses were $16.1 million and $28 million respectively.

    現在讓我們來看看損益表。截至 2023 年 12 月 31 日的三個月研發費用為 460 萬美元,而 2022 年同期三個月的研發費用為 470 萬美元。最近完成的第四季度的研發費用是由截至 2023 年 12 月 31 日和 2022 年全年正在進行的 SHIELD II 第 3 期試驗的增加所推動的。研發費用分別為1610萬美元和2800萬美元。

  • Marketing and business development expenses for the fourth quarter of 2023 were $193,000 compared to $350,000 during the prior year period.

    2023 年第四季的行銷和業務開發費用為 193,000 美元,而去年同期為 350,000 美元。

  • General and Administrative expenses for the fourth quarter of 2023 were $1.2 million compared to $1.6 million recorded in the same three-months period of 2022.

    2023 年第四季的一般及行政費用為 120 萬美元,而 2022 年同期的一般及行政費用為 160 萬美元。

  • For the fourth quarter of 2023, the company had a net loss of $6.4 million as compared to $6.6 million in the fourth quarter of 2022. For calendar year 2023, the company had a net loss of $23.9 million compared to a loss of $39.6 million and full year 2022.

    2023 年第四季,該公司淨虧損 640 萬美元,而 2022 年第四季淨虧損 660 萬美元。2023 日曆年,該公司淨虧損 2,390 萬美元,而 2022 年全年虧損 3,960 萬美元。

  • Finally, we continue to execute well on our cost containment initiatives. As such, our net cash used in operating activities for full year of 2023 decreased by $17 million as compared to calendar year 2022 from $34.3 million to $17.3 million. With that, we will now open the call to your questions. Operator?

    最後,我們繼續良好地執行成本控制計劃。因此,與 2022 年相比,我們 2023 年全年經營活動使用的淨現金減少了 1,700 萬美元,從 3,430 萬美元減少到 1,730 萬美元。現在,我們將開始回答您的問題。操作員?

  • Operator

    Operator

  • (Operator Instructions) Roy Buchanan, JMP.

    (操作員指令)Roy Buchanan,JMP。

  • Roy Buchanan - Analyst

    Roy Buchanan - Analyst

  • Hey great thanks for taking the questions. On the first, I had a couple on the SHIELD II interim Just can you remind us the powering of the interim for a successful efficacy outcome, i.e., Stopping the trial early for efficacy? And then what does the alpha spend for the interim?

    嘿,非常感謝您提出問題。首先,我在 SHIELD II 臨時試驗中遇到了一些問題,您能否提醒我們,臨時試驗的動力是為了獲得成功的療效結果,即為了療效而提前停止試驗?那麼,阿爾法在過渡期間的支出是多少呢?

  • Dikla Czaczkes Akselbrad - CEO

    Dikla Czaczkes Akselbrad - CEO

  • So, first of all, good morning and thank you for the call. The alpha depends on the fine on the overall number in general, in order to get to an early stop the powers for the interim itself in order that the committee will tell us that we should stop the trial of robust data.

    首先,早上好,感謝您的來電。阿爾法取決於總體罰款,以便儘早停止臨時本身的權力,以便委員會告訴我們應該停止對可靠數據的審判。

  • The alpha should be 0.01 and the overall the penalty of the alpha depends on the overall size of the trial. So if we are sent to 600 or whether we are sent to 800 the alpha will be different because it gives you an earlier sort of look into the data.

    alpha 應為 0.01,alpha 的總體懲罰取決於試驗的總體規模。因此,無論我們發送到 600 還是發送到 800,alpha 都會有所不同,因為它可以讓您更早查看資料。

  • I can tell you that at the end of the day SHIELD I, the alpha on the interim was very, very minimal. We had the interim on 750, if I recall and overall 1,000 patient and it was very minimal and the powering is 90%.

    我可以告訴你,最終神盾局 I 的臨時阿爾法非常非常小。如果我記得的話,我們對 750 名患者進行了臨時治療,總共有 1,000 名患者,數量非常少,供電率為 90%。

  • Roy Buchanan - Analyst

    Roy Buchanan - Analyst

  • Okay, great, and then just to be clear on the on the potential warrant exercise, again for the interim success is considered to be a recommendation to continue the trial unchanged? Correct you don't need to stop early for efficacy to be considered as a success?

    好的,很好,然後要澄清一下潛在的搜索令行使,再次,臨時成功是否被認為是繼續試驗不變的建議?對嗎?您不需要提前停止才能將功效視為成功嗎?

  • Dikla Czaczkes Akselbrad - CEO

    Dikla Czaczkes Akselbrad - CEO

  • So the 10 day period is that is that on the in effect if the study is stopped for positive data, the overall at this time we will have around year plus for the warrant, is that the risk they are all other scenarios.

    因此,10 天的期限是,如果研究因積極數據而停止,那麼此時我們將擁有大約一年的認股權證,即所有其他情況的風險。

  • Roy Buchanan - Analyst

    Roy Buchanan - Analyst

  • Okay. Got it. Thank you and then just on the pipeline, can you just discuss a bit, I guess, partnering outlook or progress for the Plex technology outside of D-PLEX100 and then just one other development activities you have planned for this year? Thanks.

    好的。知道了。謝謝您,我想您能否稍微討論一下 D-PLEX100 以外 Plex 技術的合作前景或進展,以及您今年計劃的另一項開發活動?謝謝。

  • Dikla Czaczkes Akselbrad - CEO

    Dikla Czaczkes Akselbrad - CEO

  • Sure, sure. So we are continuing and also initiating some additional discussions around the platform part of the OncoPLEX new data that we published today or referred to today is part input that we're getting from some of those discussions.

    一定一定。因此,我們正在繼續並圍繞 OncoPLEX 新數據的平台部分發起一些額外的討論,我們今天發布的或今天提到的部分輸入是我們從其中一些討論中獲得的部分輸入。

  • So understanding what should be the next step or what partners would want to see in terms of potential efficacy of the product helps research and development to direct the internal development, obviously, and some of this animal data are part of our understanding from discussion, and we are continuing robotically to discuss both the potential future collaboration of D-PLEX as well as platform related collaboration within that, we conclude on OncoPLEX.

    因此,了解下一步應該做什麼或合作夥伴希望在產品的潛在功效方面看到什麼有助於研發指導內部開發,顯然,其中一些動物數據是我們從討論中理解的一部分,並且我們正在繼續機械地討論D-PLEX 未來潛在的合作以及其中與平台相關的合作,我們在OncoPLEX 上得出結論。

  • Obviously, the timing of the maturity of this discussion is something that we cannot predict and cannot discuss, but we are very pleased with the kinds of companies that are discussing with us the level of the company that are discussing and showing interest in our approach is encouraging.

    顯然,這種討論成熟的時間是我們無法預測和討論的,但我們對與我們討論的公司類型感到非常滿意,他們正在討論並對我們的方法表現出興趣的公司的水平是令人鼓舞。

  • Roy Buchanan - Analyst

    Roy Buchanan - Analyst

  • Okay thanks for taking the questions.

    好的,謝謝您提出問題。

  • Dikla Czaczkes Akselbrad - CEO

    Dikla Czaczkes Akselbrad - CEO

  • Thank you, Roy.

    謝謝你,羅伊。

  • Operator

    Operator

  • (Operator Instructions) Balaji Prasad, Barclays.

    (操作員指示)Balaji Prasad,巴克萊銀行。

  • Unidentified Participant

    Unidentified Participant

  • Hi, good morning. This is Charles on for Balaji, thanks for taking our question. I'm wondering if it is possible for you to provide an update on the number of patients who have completed their 30-day follow-up at this time. Thank you.

    早安.我是巴拉吉的查爾斯,感謝您提出我們的問題。我想知道您是否可以提供目前已完成 30 天隨訪的患者人數的最新資訊。謝謝。

  • Dikla Czaczkes Akselbrad - CEO

    Dikla Czaczkes Akselbrad - CEO

  • Sure. So first of all, good morning, Charles. Thank you for your question and we recently announced that we recruited the 100 patient and you noticed in our in today's press release, we've already indicated that we have more than 100 patient, although only few days have passed, I think two days or three days. So things are progressing and we start to see. We obviously had some slowdown around the end of the year, beginning of the year due to the holidays and the winter break.

    當然。首先,早上好,查爾斯。謝謝您的提問,我們最近宣布我們招募了 100 名患者,您在今天的新聞稿中註意到,我們已經表示我們有超過 100 名患者,雖然只過去了幾天,我想兩天或三天。所以事情正在取得進展,我們開始看到。由於假期和寒假,我們在年底、年初顯然出現了一些放緩。

  • But we do start to see the similar trend that we saw in SHIELD I, of ramping up most of the patient that finished the follow up. Most of the 100 patient finished the 31 days follow-up, and we did not go into specific numbers, but I can tell you that we expect to see and recruitment, if we're looking at the next quarter, significantly ramping up both in terms of having sent additional centers open and some of the centers that were open, but only recently started to recruit patients at most of the 100 of finalized with 30 days.

    但我們確實開始看到與《神盾局 I》中看到的類似趨勢,即大多數完成追蹤的患者都得到了加強。100 名患者中的大多數完成了 31 天的隨訪,我們沒有透露具體數字,但我可以告訴你,如果我們著眼於下個季度,我們預計會看到招募人數和招募人數都顯著增加。開放更多中心的條款以及一些開放但最近才開始招募患者的中心的條款,在30 天內敲定的100 個中心中的大多數中心。

  • Unidentified Participant

    Unidentified Participant

  • Got it very helpful thank you.

    明白了,非常有幫助,謝謝。

  • Dikla Czaczkes Akselbrad - CEO

    Dikla Czaczkes Akselbrad - CEO

  • Thank you.

    謝謝。

  • Operator

    Operator

  • (Operator Instructions) Boobalan Pachaiyappan, H.C Wainwright.

    (操作員說明)Boobalan Pachaiyappan,H.C Wainwright。

  • Boobalan Pachaiyappan - Analyst

    Boobalan Pachaiyappan - Analyst

  • Good morning, team thanks for taking my questions. So couple of us from our side first, as we think about commercial batch production. So I'm curious how the expected COGS of D-PLEX100 compared to other platform technologies involving polymers or lipids attached to small molecules?

    早安,團隊感謝您提出我的問題。因此,當我們考慮商業批量生產時,我們首先從我們這邊開始。所以我很好奇 D-PLEX100 的預期 COGS 與涉及小分子附著的聚合物或脂質的其他平台技術相比如何?

  • Dikla Czaczkes Akselbrad - CEO

    Dikla Czaczkes Akselbrad - CEO

  • So as we see things now and for a long time, because we've built our own manufacture facility and we have full control on the manufacturing. We actually just a few months ago, passed a GMPs review by the Ministry Israel Ministry of Health that is also applicable for the European authority for the commercial stage. So our facilities now approved for GMP commercial stage and -- we have all the indication that the COGS will be less than 5% again, it's a bit early to be very specific because we do not know exactly the final price of the product, the selling price of the product, but all indication shows that it should be -- COGS should be less than 5% of sales.

    因此,正如我們現在和很長一段時間內所看到的那樣,因為我們已經建立了自己的製造設施,並且我們對製造擁有完全的控制權。實際上,就在幾個月前,我們通過了以色列衛生部的 GMP 審查,該審查也適用於歐洲當局的商業階段。因此,我們的設施現在已獲批進入 GMP 商業階段,並且 - 我們有所有跡象表明 COGS 將再次低於 5%,現在說得非常具體還為時過早,因為我們不確切知道產品的最終價格,產品的銷售價格,但所有跡象表明它應該是-COGS 應低於銷售額的5%。

  • Boobalan Pachaiyappan - Analyst

    Boobalan Pachaiyappan - Analyst

  • Great. Thanks for the clarity on then you mentioned about positive preclinical data in melanoma and colon carcinoma animal models. So I'm just curious on can you discuss the rationale behind choosing these tumor indications and also a potential commercial opportunities associated with D-PLEX100?

    偉大的。感謝您的澄清,您提到了黑色素瘤和結腸癌動物模型的積極臨床前數據。所以我很好奇您能否討論選擇這些腫瘤適應症的理由以及與 D-PLEX100 相關的潛在商業機會?

  • Dikla Czaczkes Akselbrad - CEO

    Dikla Czaczkes Akselbrad - CEO

  • So, it's not that these are the ones that we are pursuing for clinical. But the idea was to look at data because this is an intratumoral approach. We are injecting our OncoPLEX directly into the tumor and the chemotherapy is released within the tumor environment for three weeks.

    所以,臨床上我們追求的並不是這些。但我們的想法是查看數據,因為這是一種瘤內方法。我們將 OncoPLEX 直接注射到腫瘤中,化療藥物在腫瘤環境中釋放三週。

  • The idea was here to look at models that have fast growing cells and look at the approach, the local approach, the prolonged local approach in the tumor and see the effect, and we will very please that the resulted they repeated also the similar results that we saw as an adjuvant. This was nail adjuvant approach. We saw similar effect as an adjuvant that is applied into the tumor bed post resection also in animal models. So the idea was here to expand our preclinical data into and nail adjuvant approach being a fast growing cell model.

    我們的想法是觀察具有快速生長細胞的模型,觀察腫瘤中的方法、局部方法、長期局部方法並觀察效果,我們將非常高興他們的結果也重複了類似的結果我們將其視為佐劑。這是指甲輔助方法。我們在動物模型中也看到了與切除後塗抹在腫瘤床的佐劑類似的效果。因此,我們的想法是將我們的臨床前數據擴展到快速生長的細胞模型中,並確定佐劑方法。

  • Boobalan Pachaiyappan - Analyst

    Boobalan Pachaiyappan - Analyst

  • All right thank you so much for taking our questions.

    好的,非常感謝您回答我們的問題。

  • Dikla Czaczkes Akselbrad - CEO

    Dikla Czaczkes Akselbrad - CEO

  • Thank you good day.

    謝謝你美好的一天。

  • Operator

    Operator

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

    謝謝 看來不用再問了。我想交出結束語。

  • Dikla Czaczkes Akselbrad - CEO

    Dikla Czaczkes Akselbrad - CEO

  • Thank you for joining PolyPid fourth quarter and year end 2023 earnings conference call. We remain highly confident in our long-term prospects, especially the potential of our promising late-stage product candidate D-PLEX100 as always, we are grateful to our team members, existing and new shareholders and all our external partners for their commitment to our mission and their support in continuing to advance towards our goal of bringing D-PLEX100 to health care providers and patient as quickly as possible. We look forward to speaking with you again on our next conference call.

    感謝您參加 PolyPid 2023 年第四季和年底財報電話會議。我們對我們的長期前景仍然充滿信心,尤其是我們有前途的後期候選產品 D-PLEX100 的潛力一如既往,我們感謝我們的團隊成員、現有和新股東以及所有外部合作夥伴對我們的承諾我們的使命以及他們的支持繼續推進我們的目標,即盡快將D-PLEX100 帶給醫療保健提供者和患者。我們期待在下次電話會議上再次與您交談。