PDS Biotechnology Corp (PDSB) 2023 Q3 法說會逐字稿

Greetings and welcome to the PDS Biotechnology, third quarter 2023 earnings call and webcast. (Operator Instructions) As reminder, this conference is being recorded. I would now like to turn the conference over to your host, Nicole Jones, Investor Relations for PDS Biotechnology. Thank you. You may begin.

歡迎參加 PDS Biotechnology 2023 年第三季財報電話會議和網路廣播。 （操作員說明） 請注意，本次會議正在錄製中。現在我想將會議交給東道主 PDS Biotechnology 投資者關係部的 Nicole Jones。謝謝。你可以開始了。

Good morning and welcome to PDS Biotechnology, third quarter 2023 earnings conference call and webcast. On the call from the company are Dr. Frank Bedu-Addo, Chief Executive Officer, Matt Hill, Chief Financial Officer, and Dr. Lauren V. Wood Chief Medical Officer.

早安，歡迎來到 PDS Biotechnology 2023 年第三季財報電話會議和網路廣播。接聽公司電話的是執行長 Frank Bedu-Addo 博士、財務長 Matt Hill 和首席醫療官 Lauren V. Wood 博士。

Earlier this morning, PDS Biotech issued a press release announcing financial results for the quarter ended September 30, 2023. We encourage everyone to read the press release as well as PDS Biotech's report on Form 10-Q, which will be filed with the SEC shortly. The company's press release is available on the PDS website at pdsbiotech.com. In addition, this conference call is being webcast and will be archived on the company website for future reference.

今天早些時候，PDS Biotech 發布了一份新聞稿，宣布截至2023 年9 月30 日的季度財務業績。我們鼓勵大家閱讀新聞稿以及PDS Biotech 的10-Q 表格報告，該報告將很快提交給SEC 。該公司的新聞稿可在 PDS 網站 pdsbiotech.com 上取得。此外，本次電話會議正在網路直播中，並將在公司網站上存檔以備將來參考。

Before we begin, we need to remind everyone that on today's call the company will be making forward-looking statements regarding regulatory and clinical candidate development plans as well as research activities.

在開始之前，我們需要提醒大家，在今天的電話會議上，公司將就監管和臨床候選藥物開發計劃以及研究活動做出前瞻性聲明。

Certain information in this presentation may include forward-looking statements, including within the meaning of Section 21E of the United States Securities Exchange Act of 1934 as amended, and Section 27A of the United States Securities Act of 1933 as amended. Conserving PDS Biotechnology Corporation and other matters. These statements may discuss goals, intentions, and expectations as to future plans, trends, events result of operations or financial condition or otherwise based on current beliefs of the company's management as well as assumptions made by and information currently available to management.

本簡報中的某些資訊可能包含前瞻性陳述，包括經修訂的 1934 年美國證券交易法第 21E 條和經修訂的 1933 年美國證券法第 27A 條含義內的前瞻性陳述。保存PDS Biotechnology Corporation等事宜。這些陳述可能討論關於未來計劃、趨勢、營運事件結果或財務狀況的目標、意圖和期望，或基於公司管理層當前的信念以及管理層所做的假設和當前可獲得的資訊。

These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted. A description of these risks can be found on PDS Biotech's most recent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this conference call. Except to the extent required by applicable law or regulation, PDS Biotech undertakes no obligation to update the forward-looking statements included today to reflect subsequent events or circumstances.

這些陳述存在風險和不確定性，可能導致實際結果與預測不同。這些風險的描述可以在 PDS Biotech 向 SEC 提交的最新文件中找到。請注意不要過度依賴這些前瞻性陳述，這些陳述僅代表本次電話會議之日的情況。除適用法律或法規要求的範圍外，PDS Biotech 不承擔更新今天包含的前瞻性聲明以反映後續事件或情況的義務。

I will now hand the call over to Dr. Frank Bedu-Addo. Frank?

我現在將把電話轉給弗蘭克·貝杜-阿多博士。坦率？

Thank you, Nicole, and welcome to everyone to our third quarter 2023 conference call. We are excited about the strikes we are making fueled by our commitment to developing groundbreaking therapies that revolutionized cancer treatments based on our proprietary Versamune platform and IL12 fused antibody- drug conjugate PDS01ADC, commonly known as PDS0301 or M9241 clinical data stemming from the PDS01ADC asset, which we acquired nearly a year ago from Merck KGaA Darmstadt, Germany continues to advance and mature, reinforcing our belief that this innovative ADC could potentially address the safety and efficacy limitations that hasn't been observed with cytokine therapy to date.

謝謝 Nicole，歡迎大家參加我們 2023 年的第三季電話會議。我們對開發突破性療法感到興奮，這些療法基於我們專有的 Versamune 平台和 IL12 融合抗體藥物偶聯物 PDS01ADC（通常稱為 PDS0301 或 M9241 臨床數據，源自 PDS01ADC 資產），徹底改變了癌症治療，我們大約一年前從德國達姆施塔特Merck KGaA 收購的該產品不斷進步和成熟，增強了我們的信念，即這種創新的ADC 可能會解決迄今為止細胞因子療法尚未觀察到的安全性和有效性限制。

The combination of Versamune based approaches and our IL12 ADC has demonstrated the potential to overcome the limitations of effectively treating advanced cancer and extending patients' lives with immunotherapy.

基於 Versamune 的方法與我們的 IL12 ADC 的結合已證明有潛力克服免疫療法有效治療晚期癌症和延長患者生命的局限性。

Currently, we have safety data for over 250 patients who have been treated with PDS01ADC, supporting the early data, suggesting that this innovative ADC effectively directs the IL12 into the tumor. Therefore, reducing its presence in the circulating blood and subsequently limiting the adverse events that have been reported with other cytokine.

目前，我們擁有超過 250 名接受 PDS01ADC 治療的患者的安全性數據，支持了早期數據，表明這種創新的 ADC 有效地將 IL12 引導到腫瘤中。因此，減少其在循環血液中的存在，從而限制已報告的其他細胞因子的不良事件。

In addition, the increased and sustained presence of IL12 in the tumor, has been shown in our ongoing trials to enhance the clinical activity. This novel modification of IL12, therefore presents us with a unique opportunity to address a broad range of cancers.

此外，我們正在進行的試驗表明，腫瘤中 IL12 的增加和持續存在可增強臨床活性。因此，IL12 的這種新穎修飾為我們提供了治療多種癌症的獨特機會。

We continue to move this ADC forward with various promising approaches. It is being developed as a monotherapy is also being developed in combination with Versamune based approaches and also in combination with other standards of care. I will talk more about these updates on PDS01ADC later on the call.

我們繼續透過各種有前景的方法推動該 ADC 向前發展。它正在開發為單一療法，也正在與基於 Versamune 的方法以及其他護理標準相結合進行開發。我將在稍後的電話會議上詳細討論 PDS01ADC 的這些更新。

We are pleased with our current progress driven by our mission to develop groundbreaking therapies that transform cancer treatment. Our immediate objective revolves around progressing our primary clinical candidate, PDS0101 to the market. PDS0101 represents a novel investigational HPV-16 targeted immunotherapy. That triggers a potent and precise T cell response against HPV-16 positive cancers.

我們對目前的進展感到高興，這是我們的使命所推動的，即開發改變癌症治療的突破性療法。我們的近期目標圍繞著將我們的主要臨床候選藥物 PDS0101 推向市場。 PDS0101 代表了一種新型研究中的 HPV-16 標靶免疫療法。這會觸發針對 HPV-16 陽性癌症的有效且精確的 T 細胞反應。

This quarter we made significant progress on our Versamune platform. Specifically with our Phase 2, VERSATILE-002 trial, we hosted a positive key opinion leader, our KOL event that included key opinion leaders who have been part of the VERSATILE-002 trials and others who have not been part of the trial and our leaders in the head and neck cancer field.

本季度，我們在 Versamune 平台上取得了重大進展。具體來說，在我們的第二階段VERSATILE-002 試驗中，我們舉辦了一場積極的關鍵意見領袖活動，我們的KOL 活動包括參與VERSATILE-002 試驗的關鍵意見領袖和其他未參與試驗的人以及我們的領導者在頭頸癌領域。

It was important to understand how head and neck cancer expert oncologists view the trial results and the potential for PDS0101 and KEYTRUDA to become the standard of care for recurrent or metastatic head and neck cancer. Overall, the experts were enthusiastic about the updated VERSATILE-002 data and the planned initiation of the Phase 3, VERSATILE-003 trial.

了解頭頸癌專家腫瘤學家如何看待試驗結果以及 PDS0101 和 KEYTRUDA 成為復發性或轉移性頭頸癌護理標準的潛力非常重要。總體而言，專家們對更新的 VERSATILE-002 數據和計劃啟動的 3 期 VERSATILE-003 試驗充滿熱情。

At this event, we presented data from both the immune checkpoint Inhibitor Naive or ICI naive and the ICI resistant patient cohorts, both of which demonstrated impressive patient overall survival. For today's discussion on the VERSATILE-002 trial, we will focus on the ICI naive group. With this population, we reported a 24 months overall survival rate of 74%, which means that on the combination of PDS0101 and KEYTRUDA, the probability that a patient will live at least two years, it's 74%.

在本次活動中，我們展示了免疫檢查點抑制劑未使用或 ICI 未使用以及 ICI 抗藥性患者群組的數據，這兩者都顯示出令人印象深刻的患者整體存活率。對於今天關於 VERSATILE-002 試驗的討論，我們將重點放在 ICI 初始組。對於這個族群，我們報告的 24 個月總存活率為 74%，這意味著在 PDS0101 和 KEYTRUDA 聯合治療下，患者至少存活兩年的機率為 74%。

To put this number into perspective, published 24 months overall survival rates for approved ICIs is less than 30%, meaning that on today's approved therapies. The probability that the patient will live for at least two years is only about 30%. The VERSATILE-002 data suggest that patients are living longer when treated with the PDS0101 plus KEYTRUDA combination.

從這個數字來看，已公佈的已批准 ICI 的 24 個月總存活率低於 30%，這意味著採用當今已批准的療法。病人至少能活兩年的機率只有30%左右。 VERSATILE-002 數據表明，接受 PDS0101 加 KEYTRUDA 組合治療的患者壽命更長。

It is important to note that disease control, which includes stable disease and tumor shrinkage, was seen in 81% of patients. Tumor shrinkage was reported in 60% of patients and a confirmed objective response rate OORR of 27% was reported based on investigator assessment with respect to safety, the combination continues to be well tolerated with 13% of patients having grade three treatment-related toxicities and no patients having any Grade 4 or Grade 5 treatment-related events.

值得注意的是，81% 的患者出現了疾病控制，包括疾病穩定和腫瘤縮小。據報道，60% 的患者腫瘤縮小，根據研究者對安全性的評估，確認的客觀緩解率OORR 為27%，該組合仍然具有良好的耐受性，13% 的患者出現三級治療相關毒性，且沒有患者發生任何 4 級或 5 級治療相關事件。

To put this in context in KEYNOTE- 048, it is reported that 17% of patients on KEYTRUDA monotherapy experienced Grade 3 to 5 treatment-related toxicities and 72% of patients on KEYTRUDA plus chemotherapy experienced Grade 3 to Grade 5 treatment-related toxicities. With this data, we believe that we are on track to revolutionize the treatment of head and neck cancer with improved clinical outcomes and better tolerability.

結合KEYNOTE-048 的背景來看，據報道，接受KEYTRUDA 單藥治療的患者中有17% 經歷了3 至5 級治療相關毒性，接受KEYTRUDA 加化療的患者中有72% 經歷了3 至5 級治療相關毒性。有了這些數據，我們相信我們有望徹底改變頭頸癌的治療方法，改善臨床結果並提高耐受性。

Furthermore, in October 2023, preliminary biomarker data from the VERSATILE-002 trial was presented at the European Society for Medical Oncology for ESMO Congress 2023, the combination of PDS0101 and KEYTRUDA appears to be promoting a predominant TH1 immunologic profile that is associated with enhanced CD8 killer T cell induction and activity.

此外，2023 年 10 月，在歐洲腫瘤內科學會 2023 年 ESMO 大會上公佈了 VERSATILE-002 試驗的初步生物標誌物數據，PDS0101 和 KEYTRUDA 的組合似乎正在促進與增強的 CD8 相關的主要 TH1 免疫學特徵殺傷性T 細胞的誘導和活性。

The combination also led to subsequent decreases in the population of CD8 killer T cells in the circulating blood. We are encouraged that these observations align with other Phase 2 studies reporting that PDS0101 induced poly functional CD8 killer T cells do not reside in the blood, but wrapper traffic to tumors.

這種組合也導致循環血液中 CD8 殺傷 T 細胞數量的減少。我們感到鼓舞的是，這些觀察結果與其他 2 期研究一致，報告指出 PDS0101 誘導的多功能 CD8 殺傷 T 細胞並不駐留在血液中，而是包裝運送到腫瘤中。

These data support the two year 74% overall survival rates reported in VERSATILE-002. Beyond the VERSATILE-002 trail, our focus has remained on steadily advancing preparations for our Phase 3 VERSATILE-003 trials. In October 2023, we announced feedback from the FDA regarding the amended investigational New Drug application can thereafter feedback on the final clinical trial protocol.

這些數據支持 VERSATILE-002 中報告的兩年 74% 的總體存活率。除了 VERSATILE-002 試驗之外，我們的重點仍然是穩步推進 3 期 VERSATILE-003 試驗的準備工作。 2023 年 10 月，我們宣布 FDA 就修訂後的研究性新藥申請提供回饋，此後可以對最終臨床試驗方案進行回饋。

We currently have up to 60 sites selected globally and are going through the qualifying process. As anticipated, the FDA reviewed Phase 3 clinical trial design has been pivotal to our business development discussions, which has yielded positive insights from prospective partners. Our clinical and medical teams are assessing final details of the trial. And therefore, we anticipate VERSATILE-003 will now start in the first quarter of 2024.

目前，我們在全球範圍內選擇了多達 60 個站點，並且正在進行資格審查過程。正如預期的那樣，FDA 審查的 3 期臨床試驗設計對於我們的業務發展討論至關重要，這從潛在合作夥伴那裡產生了積極的見解。我們的臨床和醫療團隊正在評估試驗的最終細節。因此，我們預計 VERSATILE-003 將於 2024 年第一季啟動。

We'll keep you updated on our next steps as we progress, toward trial initiation. Now, turning to immunotherapy. In October 2023, data from the Phase 2 clinical trial were featured in an oral presentation at the American Society for Radiation Oncology Annual Meeting known as ASTRO These data demonstrated that PDS0101 in combination with standard of care chemo radiotherapy was associated with a rapid decline in HPV positive circulating tumor DNA.

隨著試驗啟動的進展，我們將隨時向您通報我們的後續步驟。現在，轉向免疫療法。 2023 年 10 月，2 期臨床試驗的數據在美國放射腫瘤學會年會 ASTRO 上進行了口頭報告。這些數據表明，PDS0101 與標準護理化療放療相結合與 HPV 的快速下降有關循環腫瘤 DNA 呈陽性。

At five weeks of treatment. ctDNA clearance of 92% was reported with PDS0101. Whereas 53% clearance was observed in patients receiving standard of care chemo radiotherapy alone. These biomarker data support the 100% response rate in patients receiving PDS0101 and standard of care, which was reported at SITC 2022.

治療五週時。據報道，PDS0101 的 ctDNA 清除率為 92%。而在僅接受標準護理化療放療的患者中觀察到 53% 的清除率。這些生物標記數據支持接受 PDS0101 和標準護理的患者的 100% 有效率，這已在 SITC 2022 上報告。

ASTRO trial continues to progress, we will provide further updates. Now shifting to our IL12 field antibody drug conjugate known as PDS01ADC. PDS01ADC is a novel ADC or anti body drug conjugates, that enhances the proliferation potency and longevity of T cells and IL12 in the tumor.

ASTRO 試驗仍在繼續進行，我們將提供進一步的更新。現在轉向我們的 IL12 場抗體藥物偶聯物，稱為 PDS01ADC。 PDS01ADC 是一種新型 ADC 或抗體藥物綴合物，可增強腫瘤中 T 細胞和 IL12 的增殖能力和壽命。

Let's begin by discussing the compelling updated data from the National Cancer Institute-led triple combination trial that was reported on November 9. This study is a Phase 2 trial of PDS0101, PDS01ADC and an investigational ICI. This combination has undergone evaluation across multiple HPV-positive cancers, encompassing anal, cervical, head and neck, vaginal and vulvar cancers in two groups of advanced cancer patients.

讓我們先討論 11 月 9 日報道的國家癌症研究所主導的三聯試驗令人信服的最新數據。這項研究是 PDS0101、PDS01ADC 和研究性 ICI 的 2 期試驗。該組合已在兩組晚期癌症患者中對多種 HPV 陽性癌症進行了評估，包括肛門癌、子宮頸癌、頭頸癌、陰道癌和外陰癌。

The ICI naive group constituted patients unresponsive to standard of care treatments that have not yet received ICI therapy. The ICI resistant group included individuals who had shown no response to multiple prior treatments, including ICI therapy. Regarding the ICI naive group the chart shows the confirmed objective responses reported in VERSATILE-002 and the triple combination based on investigate assessment, both shown in green as well as published KEYNOTE- 048 data.

ICI 初治組由尚未接受 ICI 治療的標準護理治療無反應的患者組成。 ICI 抗藥性組包括對先前多種治療（包括 ICI 治療）沒有反應的個體。關於 ICI 初始組，該圖表顯示了 VERSATILE-002 中報告的已確認的客觀反應以及基於調查評估的三重組合，兩者均以綠色顯示以及已發布的 KEYNOTE-048 數據。

Notable is the objective response rate of 75% with the triple combination and 27% with the dual combination with KEYTRUDA monotherapy and KEYTRUDA plus chemotherapy. The published objective response rates were 19% and 36% respectively.

值得注意的是，三重療法的客觀緩解率為 75%，而 KEYTRUDA 單藥療法和 KEYTRUDA 加化療的雙重療法的客觀緩解率為 27%。公佈的客觀緩解率分別為 19% 和 36%。

The next figure contains updated survival data from VERSATILE-002 and the triple combination trial in green as well as published data from KEYNOTE- 048. What is notable here is the fact that despite the lower objective response rate with PDS0101 plus KEYTRUDA , the survival benefit seen with the PDS0101 plus KEYTRUDA combination as well as the triple combination appears to be similar with 24 months survival rates of 74% and 75% respectively.

下圖包含 VERSATILE-002 的更新生存數據和綠色三聯試驗以及 KEYNOTE-048 的已發表數據。此處值得注意的是，儘管 PDS0101 加 KEYTRUDA 的客觀緩解率較低，但生存獲益PDS0101 加KEYTRUDA 組合以及三聯組合的結果似乎相似，24 個月存活率分別為74% 和75%。

The triple combination also shows a compelling three year survival of 75%. These data suggest that PDS0101 may play a significant role in extending survival in the ICI naive population independent of objective response rate, while PDS01ADC appears to promote strong objective responses in this population.

三重組合也顯示出令人驚嘆的 75% 的三年存活率。這些數據表明，PDS0101 可能在延長 ICI 初治人群的生存期方面發揮重要作用，與客觀緩解率無關，而 PDS01ADC 似乎可以促進該人群的強烈客觀緩解。

The median overall survival has not yet been reached in either the VERSATILE-002 for the triple combination studies, to contextualize published data on standard of care immune checkpoint inhibitors or ICI report that at 12 months, only 30% to 50% of these patients with typically be expected to remain alive and less than 30% of the patients could be expected to remain alive at 24 months.

三重組合研究的 VERSATILE-002 尚未達到中位總生存期，以結合已發布的護理標準免疫檢查點抑製劑數據或 ICI 報告，在 12 個月時，這些患者中只有 30% 至 50%通常預期仍存活，不到30% 的患者預計在24 個月時仍存活。

Therefore, survival associated with the PDS0101 combination regimen at two years for VERSATILE-002 and three years for the triple combinations is notable. Now looking at the ICI resistant group where there's a significant unmet medical need and no FDA approved product. These are the patients who have failed all treatment options, including high ICIs in these ICI resistant patients with HPV-positive cancers, the reported median overall survival is only about three to four months in the ICI resistant patients. This slide shows that the published objective response rate with systemic therapies, including high-dose chemotherapy, is 42%.

因此，與 PDS0101 組合方案相關的 VERSATILE-002 的兩年存活率和三重組合的三年存活率是值得注意的。現在看看 ICI 抗藥性群體，他們的醫療需求顯著未被滿足，並且沒有 FDA 批准的產品。這些患者所有治療方案都失敗了，包括這些 ICI 抗藥性的 HPV 陽性癌症患者中的高 ICI，據報道，ICI 抗藥性患者的中位總生存期僅為約三到四個月。這張投影片顯示，已發表的全身性治療（包括高劑量化療）的客觀緩解率為 42%。

The objective response rate was 0% with PDS0101 plus KEYTRUDA in VERSATILE-002, 5% in patients who received PDS0101 with low doses of PDS01ADC and ICI therapy and 63% in patients who received PDS0101 with initial high doses of PDS01ADC and ICI therapy. Again, these data appear to demonstrate the role of PDS01ADC in promoting strong and compelling objective response rates, even in late stage ICI resistant cancer patients.

在 VERSATILE-002 中，PDS0101 加 KEYTRUDA 的客觀緩解率為 0%，接受 PDS0101 合併低劑量 PDS01ADC 和 ICI 治療的患者為 5%，接受 PDS0101 合併初始高劑量 PDS01ADC 和 ICI 治療的患者為 63%。這些數據再次證明了 PDS01ADC 在促進強大且令人信服的客觀緩解率方面的作用，即使在晚期 ICI 抗藥性癌症患者中也是如此。

Let's now take a look at the overall survival rate in ICI resistant patients. On the slide we will see that irrespective of objective response rate. The PDS0101 containing therapies shown by the green bars, provide durable survival results despite the lack of confirmed objective responses with PDS0101 plus KEYTRUDA .

現在讓我們來看看 ICI 抗藥性患者的總存活率。在幻燈片中，無論客觀回應率如何，我們都會看到這一點。儘管 PDS0101 加 KEYTRUDA 缺乏經證實的客觀反應，但包含綠色條所示療法的 PDS0101 可提供持久的生存結果。

The 12 month overall survival rate was 56% VERSATILE-002 and 72% in the triple combination with systemic therapies the published 12 month overall survival rate is 36%. This data provides compelling evidence regarding the role of PDS0101 in the survival of ICI naive and ICI refractory HPV16 positive patients and the potential role of PDS01ADC in further extending survival and also promoting objective responses in this population.

VERSATILE-002 的 12 個月總存活率為 56%，在與全身療法的三合療法中為 72%，公佈的 12 個月總存活率為 36%。這些數據提供了令人信服的證據，證明 PDS0101 在 ICI 初治和 ICI 難治性 HPV16 陽性患者的生存中的作用，以及 PDS01ADC 在進一步延長生存期並促進該人群的客觀緩解方面的潛在作用。

This study provides compelling evidence that supports the potential synergy between our Versamune based targeted T cell immunotherapies and our IL12 fused antibody drug conjugate that provides the sustained presence of IL12 in the tumor that's providing further expansion and activation of the Versamune induced multifunctional killer T cells within the patient's tumor.

這項研究提供了令人信服的證據，支持我們基於Versamune 的靶向T 細胞免疫療法與我們的IL12 融合抗體藥物偶聯物之間的潛在協同作用，該藥物偶聯物使IL12 在腫瘤中持續存在，從而進一步擴增和活化Versamune 誘導的多功能殺傷T 細胞患者的腫瘤。

We believe that this data supports broader application of this combination beyond HPV-positive cancer and provides a unique potential to effectively address multiple advanced cancers in our development pipeline. As a reminder, the safety update for this trial was announced in late December 2022, in 50 patients of the 8% of patients experienced Grade 3 related Grade 3 treatment-related adverse events or AEs and 4% of patients experienced Grade 4 related adverse events, to put the safety profile in context in the KEYNOTE- 048 study, it is reported that the combination of KEYTRUDA and chemotherapy resulted in 72% of patients having Grade 3 through Grade 5 treatment-related adverse events.

我們相信，這些數據支持該組合在 HPV 陽性癌症之外更廣泛的應用，並為我們的開發管道中有效解決多種晚期癌症提供了獨特的潛力。提醒一下，該試驗的安全性更新於2022 年12 月下旬宣布，在50 名患者中，8% 的患者經歷了3 級相關的3 級治療相關不良事件或AE，4% 的患者經歷了4 級相關不良事件，為了將安全性放在 KEYNOTE-048 研究的背景下，據報導 KEYTRUDA 和化療聯合使用導致 72% 的患者出現 3 級至 5 級治療相關不良事件。

We are therefore pleased with the tolerability profile that is emerging for PDS01ADC, even when administered in combination with other oncology agents. As I mentioned earlier to date, we have safety data from over 250 patients dosed with PDS01ADC.

因此，我們對 PDS01ADC 出現的耐受性感到滿意，即使與其他腫瘤藥物合併使用也是如此。正如我之前提到的，迄今為止，我們有超過 250 名服用 PDS01ADC 的患者的安全數據。

This provides further evidence that this novel modification of IL12 may be effective in mitigating previously observed cytokine side effects while promoting improved clinical benefit and further justifies its continued development by PDS Biotech.

這提供了進一步的證據，表明 IL12 的這種新型修飾可能有效減輕先前觀察到的細胞因子副作用，同時促進改善臨床效益，並進一步證明 PDS Biotech 繼續開發它是合理的。

PDS01ADC is also being studied independently of the Versamune immunotherapies. The National Cancer Institute recently, presented data for the ongoing Phase 2 clinical trial of PDS01ADC in combination with docetaxel chemotherapy in advanced metastatic castration sensitive in castration resistant prostate cancer patients. At the cytokine 2023 Annual Meeting.

PDS01ADC 也正在獨立於 Versamune 免疫療法進行研究。美國國家癌症研究所最近公佈了正在進行的 PDS01ADC 聯合多西他賽化療治療去勢抵抗性前列腺癌患者晚期轉移性去勢敏感的 2 期臨床試驗的數據。在細胞激素2023年年會上。

This trial is the first clinical study of an immunocytokine with docetaxel in prostate cancer. The studies investigating the safety immune responses and preliminary clinical activity of the combination in advanced prostate cancer patients.

該試驗是免疫細胞激素與多西紫杉醇治療前列腺癌的首個臨床研究。這些研究調查了該組合在晚期前列腺癌患者中的安全性免疫反應和初步臨床活性。

The trial evaluated three doses of PDS01ADC in combination with docetaxel and showed that the combination was well tolerated at all tested doses with less than 10% of patients having a Grade 4 toxicity. Most importantly, over 60% of patients had a prostate-specific antigen for PSA level reduction of greater than 60% with some patients having a 90 to 100 PSA reduction.

該試驗評估了三種劑量的 PDS01ADC 與多西紫杉醇的組合，結果顯示該組合在所有測試劑量下具有良好的耐受性，不到 10% 的患者出現 4 級毒性。最重要的是，超過 60% 的患者的前列腺特異性抗原使 PSA 水平降低超過 60%，其中一些患者的 PSA 降低了 90 至 100。

As shown reduced PSA levels were documented in all 18 patients. PDS01ADC activates T cells, natural killer cells and natural killer T cells while reducing the presence of immune suppressive regulatory T cells. As a result, we believe that we now also have an opportunity to apply PDS01ADC for advanced and difficult-to-treat tumors by combining PDS01ADC with standard of care chemotherapy and radiation therapy.

如圖所示，所有 18 名患者的 PSA 水平均下降。 PDS01ADC 會活化 T 細胞、自然殺手細胞和自然殺手 T 細胞，同時減少免疫抑制性調節 T 細胞的存在。因此，我們相信，我們現在也有機會透過將 PDS01ADC 與標準護理化療和放射治療相結合，將 PDS01ADC 應用於晚期和難以治療的腫瘤。

PDS01ADC is also being investigated by the National Cancer Institute in a Phase 1/2 study in patients with intermediate and high-risk locally advanced prostate cancer in combination with radiation therapy. As mentioned previously, PDS01ADC is also being studied as a monotherapy by the National Cancer Institute in an ongoing Phase 2 clinical trial in Kaposis sarcoma at PDS Biotech, we are highly optimistic about the potential of this novel PDS01ADC asset in cancer therapy.

美國國家癌症研究所也在 1/2 期研究中對 PDS01ADC 進行研究，該研究針對中危險群和高風險局部晚期前列腺癌患者，並結合放射治療。如前所述，美國國家癌症研究所也在 PDS Biotech 正在進行的卡波西斯肉瘤 2 期臨床試驗中研究 PDS01ADC 作為單一療法，我們對這種新型 PDS01ADC 資產在癌症治療中的潛力高度樂觀。

Switching now to preclinical development studies. The National Cancer Institute has developed a second novel approach to treating immune checkpoint inhibitor resistant cancers by using Versamune based immunotherapy and PDS01ADC in combination with histone deacetylaseor or HDAC inhibitor another oncology standard of care.

現在轉向臨床前開發研究。美國國家癌症研究所開發了第二種治療免疫檢查點抑制劑抗藥性癌症的新方法，即使用基於Versamune 的免疫療法和PDS01ADC 與組蛋白去乙醯酶或HDAC 抑制劑（另一種腫瘤護理標準）相結合。

The preclinical data were presented during the recently concluded 2023 Annual Meeting of the Society for Immunotherapy of Cancer or SITC. In this preclinical study superior anti-tumor activity was observed in ICI resistant tumor models with Versamune based immunotherapy, PDS01ADC and antenna [stat], a class 1 HDAC inhibitor.

這些臨床前數據是在最近結束的癌症免疫治療協會 (SITC) 2023 年年會上發表的。在這項臨床前研究中，在使用基於 Versamune 的免疫療法、PDS01ADC 和 Antenna [stat]（一種 1 類 HDAC 抑制劑）的 ICI 抗藥性腫瘤模型中觀察到優異的抗腫瘤活性。

This novel triple combination proof of concept study is under consideration as a potential approach for initial clinical studies of PDS0301 to treat Mach one specific cancers. We are encouraged by the potential of this combination.

這項新穎的三重組合概念驗證研究正在考慮作為 PDS0301 治療馬赫一特定癌症的初步臨床研究的潛在方法。我們對這種組合的潛力感到鼓舞。

The National Cancer Institute will lead this clinical trial under our established co-operative Research and Development Agreement, and we anticipate it will begin in the first half of 2024.

美國國家癌症研究所將根據我們既定的合作研究與開發協議領導這項臨床試驗，我們預計將於 2024 年上半年開始。

PDS Biotech has had a fruitful quarter, and we are preparing to finish out the year strong as we move into 2024 to summarize, we hosted AK, successful KOL event where we announced positive updated overall survival and safety data from the VERSATILE-002 trials and gained important insights from head and neck oncology leaders about the potential of PDS0101 in the treatment of, HPV-positive head and neck cancer.

PDS Biotech 度過了一個碩果累累的季度，我們正準備在進入2024 年時以強勁的勢頭結束這一年。總而言之，我們舉辦了AK，成功的KOL 活動，其中我們宣布了來自VERSATILE-002 試驗的積極更新的整體生存和安全數據，以及從頭頸腫瘤學領導者那裡獲得了關於 PDS0101 在治療 HPV 陽性頭頸癌方面的潛力的重要見解。

Preliminary biomarker data presented at ESMO from the VERSATILE-002 trial supports the reported overall survival results. The biomarker data from the immunoserve trial presented at ASTRO demonstrates the role of PDS0101 in eliminating circulating tumor HPV DNA.

ESMO 上發布的 VERSATILE-002 試驗的初步生物標記數據支持了報告的整體生存結果。 ASTRO 上發表的免疫服務試驗的生物標記數據證明了 PDS0101 在消除循環腫瘤 HPV DNA 方面的作用。

The updated triple combination data demonstrates the role of PDS01ADC in promoting durable overall survival and objective responses even in difficult to treat ICI resistant patients. Data from thePDS01ADC and docetaxel trial presented at cytokine demonstrated tolerability of the combination and encouraging PSA biomarker results and immune responses.

更新的三聯組合數據證明了 PDS01ADC 在促進持久整體生存和客觀反應方面的作用，即使在難以治療的 ICI 抗藥性患者中也是如此。來自細胞因子的 PDS01ADC 和多西紫杉醇試驗的數據證明了該組合的耐受性，並鼓勵 PSA 生物標記結果和免疫反應。

With that, I'd now like to turn the call over to Matt to discuss the financial summary. Matt?

現在，我想將電話轉給馬特，討論財務摘要。馬特？

Now turning to our financial results for the three months ended September 30, 2023. Net loss for the period was approximately $10.8 million, or $0.35 per basic and diluted share, compared to a net loss of approximately $7.4 million or $0.26 per basic and diluted share for the three months ended September 30, 2022. The higher net loss this quarter was primarily due to costs incurred in connection with our research and development and clinical programs.

現在轉向我們截至2023 年9 月30 日的三個月的財務業績。該期間的淨虧損約為1080 萬美元，或每股基本股和稀釋股0.35 美元，而淨虧損約為740 萬美元，或每股基本股和稀釋股0.26 美元截至 2022 年 9 月 30 日的三個月。本季淨虧損較高主要是由於我們的研發和臨床項目產生的成本。

Research and development costs, which includes clinical and manufacturing expenses for the quarter ended September 30, 2023, increased to approximately $6.4 million compared to $4.3 million for the same period of 2022.

截至 2023 年 9 月 30 日的季度，研發成本（包括臨床和製造費用）增加至約 640 萬美元，而 2022 年同期為 430 萬美元。

The increase of $2 million is primarily attributable to an increase of $1.3 million in clinical trial costs and $0.7 million in personnel costs, which includes $0.3 million in non-cash stock-based compensation, general and administrative expenses for the second quarter of 2023 increased to approximately $4.1 million compared to $2.9 million for the same period of 2022.

增加 200 萬美元的主要原因是臨床試驗成本增加了 130 萬美元，人員成本增加了 70 萬美元，其中包括 30 萬美元的非現金股票薪酬、2023 年第二季度的一般和管理費用增加至約410萬美元，而2022 年同期為290 萬美元。

The increase of $1.2 million is primarily attributable to an increase of $0.7 million in personnel costs, including $0.5 million in non-cash stock-based compensation and $0.5 million investor relations costs.

增加 120 萬美元主要是由於人事成本增加 70 萬美元，其中包括 50 萬美元的非現金股票薪酬和 50 萬美元的投資者關係成本。

Our cash and cash equivalents as of September 30, 2023, totaled approximately $54.3 million. We continue to be prudent with our cash expenditures, and we believe that initiating the VERSATILE-003 Phase 3 clinical trial in the first quarter of 2024 are available cash resources will sustain our operational and research and development endeavors into the third quarter of 2024.

截至 2023 年 9 月 30 日，我們的現金和現金等價物總計約為 5,430 萬美元。我們對現金支出持續保持謹慎態度，我們相信，在 2024 年第一季啟動 VERSATILE-003 3 期臨床試驗的可用現金資源將維持我們的營運和研發工作到 2024 年第三季。

We expect to execute our current operational and research and development endeavors by obtaining additional capital, principally through entering into collaborations, strategic alliances and license agreements with third parties and or public or private debt and or equity financing. We have had and continue to provide what we believe to be favorable development milestones to the market and have upcoming development milestones we believe may provide additional catalysts to investors at this time.

我們希望透過獲得額外資本來執行我們目前的營運和研發工作，主要是透過與第三方和/或公共或私人債務和/或股權融資達成合作、策略聯盟和授權協議。我們已經並將繼續為市場提供我們認為有利的發展里程碑，並且我們認為即將到來的發展里程碑可能會為投資者提供額外的催化劑。

This completes my financial discussion. I would like to hand the call back over to the operator for the Q&A session. Operator?

我的財務討論到此結束。我想將電話轉交給接線生進行問答環節。操作員？

Thank you, at this time. Our first question comes from the line of Louise Chen with Cantor Fitzgerald. Please proceed with your question.

謝謝你，此時。我們的第一個問題來自路易絲·陳（Louise Chen）與坎托·菲茨杰拉德（Cantor Fitzgerald）的台詞。請繼續你的問題。

Hi. Congratulations on the progress this quarter and thanks for taking my questions. So I had a few questions for you. As you think about 2024 and we table set for next year, what are the key milestones, catalysts readouts that you think we should have on our radar? We how do you think about OpEx for fourth quarter '23 and 2024 in light of the fact that you're going to start this VERSATILE-003, Phase 3? And the last question is when do you think we'll see data on VERSATILE-003? Thank you.

你好。恭喜本季的進展，並感謝您回答我的問題。所以我有幾個問題想問你。當您考慮 2024 年以及我們為明年制定的表格時，您認為我們應該關注哪些關鍵里程碑、催化劑讀數？鑑於您將啟動 VERSATILE-003 第 3 階段，您如何看待 23 年第四季和 2024 年的營運支出？最後一個問題是，您認為我們什麼時候會看到 VERSATILE-003 的資料？謝謝。

Louise. Thank you very much for your questions. I'll answer two and I'll hand over the OpEx to Matt but in terms of the key milestones and catalysts as we move into 2024, as I mentioned, key will be getting VERSATILE-003 up and running, we also have announced and stated that we do anticipate and expect the final data readout from VERSATILE-002 sometime in the second quarter of 2024.

路易絲.非常感謝您的提問。我會回答兩個，我會將營運支出交給 Matt，但就我們進入 2024 年的關鍵里程碑和催化劑而言，正如我所提到的，關鍵將是讓 VERSATILE-003 啟動並運行，我們還宣布了表示我們確實預期VERSATILE-002 的最終數據會在2024 年第二季的某個時候讀出。

As I also just mentioned, we do expect to initiate on the PDS0103 clinical trial in Mach one related cancers early in 2024 at least in the first half of 2024. We also are hopeful that we will have the preliminary data from our neo-adjuvant trial ongoing at the Mayo Clinic in early stage and oral cancer, HPV positive oral cancer where we're looking at PDS0101, both as a monotherapy and also in combination with KEYTRUDA. We have not had any readout from that study yet. And we're hopeful that we will get that in sometime the first half of 2024 based upon what we've been informed by the PI And their goal of presenting at an upcoming conference.

正如我剛才提到的，我們確實預計在 2024 年初至少在 2024 年上半年啟動針對馬赫一相關癌症的 PDS0103 臨床試驗。我們也希望能夠獲得新輔助試驗的初步數據Mayo Clinic 正在進行早期口腔癌、HPV陽性口腔癌的治療，我們正在研究PDS0101，既可以作為單一療法，也可以與KEYTRUDA 合併使用。我們還沒有得到該研究的任何結果。我們希望根據 PI 提供的資訊以及他們在即將舉行的會議上演示的目標，我們能夠在 2024 年上半年的某個時候實現這一目標。

And also we do expect to have additional data readouts on the immunotherapy cervical cancer trial and so we do have a number of potential milestones coming up as well as readouts forward. And we as, we don't talk too much about the trials going on also the National Cancer Institute, we had the readout from the docetaxel as well as the PDS01ADC.

而且我們確實希望獲得有關免疫治療子宮頸癌試驗的額外數據讀數，因此我們確實有許多潛在的里程碑即將到來以及未來的讀數。我們不會過多談論國家癌症研究所正在進行的試驗，我們有多西紫杉醇和 PDS01ADC 的讀數。

We also have those studies ongoing in early-stage prostate cancer locally advanced prostate cancer. We hopeful that we'll see some data from that trial in 2024. We have the monotherapy trial going into Kaposis sarcoma. Hopefully, we will see some data from that trial in 2024. And I'm -- so I think I think we will have hopefully a pretty busy 2024 and hopefully, we'll be able to provide quite a number of data readouts as we go through the year.

我們也在早期前列腺癌和局部晚期前列腺癌中正在進行這些研究。我們希望能在 2024 年看到該試驗的一些數據。我們正在進行針對卡波西氏肉瘤的單一療法試驗。希望我們能在 2024 年看到該試驗的一些數據。所以我認為我們希望 2024 年會非常繁忙，希望我們能夠提供相當多的數據讀數走過這一年。

In terms of VERSATILE-003 trials. I think we'll have much more clarity on when we'll have data readouts, as you note that when we will be able to provide the data readout will be at our first interim data readout. Now when we get to the first interim data readout depends on the number of sites that we have open at the start, as well as the enrollment rates that we will encounter with that, we'll be able to achieve as the trial goes and initiates and progresses.

就 VERSATILE-003 試驗而言。我認為我們會更清楚地了解何時進行數據讀出，正如您所注意到的，我們何時能夠提供數據讀出將是在我們的第一次臨時數據讀出時。現在，當我們獲得第一個臨時數據讀數時，取決於我們一開始打開的站點數量，以及我們將遇到的註冊率，隨著試驗的進行和啟動，我們將能夠實現並取得進展。

What we are currently doing as I mentioned, we have 60 sites that have been identified so far. The goal is to get to 100 sites. And what we're trying to understand now is how rapidly each site will come onboard. And as we understand better how we will open the sites and the sequence of open the sites and how many sites will be open at any particular time, we will then be able to provide a much more and would be more confident in the timelines that we'll be able to provide you as to when we will get to that interim data readout. But we are working aggressively on that now and hopefully should be able to provide that information very soon.

正如我所提到的，我們目前正在做的事情，到目前為止我們已經確定了 60 個站點。目標是覆蓋 100 個站點。我們現在想要了解的是每個網站的上線速度有多快。隨著我們更好地了解我們將如何打開網站、打開網站的順序以及在任何特定時間將打開多少個網站，我們將能夠提供更多信息，並對我們的時間表更有信心。我們將能夠向您提供有關我們何時獲得臨時數據讀數的資訊。但我們現在正在積極努力，希望能夠很快提供這些資訊。

Matt, I'll hand over to you for the operating costs.

馬特，我會把營運費用交給你。

Thank you, Frank, Louise, thanks for your question. I want to let you know that that's a good question. We've been I would say we've been extremely prudent with the use of the company's cash and capital. When you look over the last probably seven quarters or so, we burned about little north of $6 million per quarter. And with a significant number of studies that we have ongoing, not only VERSATILE-002 trial, but also the trials with the NCI the IITs with the MD Anderson as well as Mayo. We've been extremely frugal in our opinion in how we manage these costs. But as we prepare to move forward into Phase 3 clinical trial, obviously those costs are going to increase.

謝謝法蘭克、路易絲，謝謝你的問題。我想讓你知道這是一個好問題。我想說，我們對公司現金和資本的使用一直非常謹慎。當你回顧過去大概七個季度左右的情況時，我們每季燒掉的資金大約是 600 萬美元。我們正在進行大量研究，不僅包括 VERSATILE-002 試驗，還包括 NCI、IIT 與 MD 安德森以及 Mayo 的試驗。我們認為在管理這些成本方面一直非常節儉。但當我們準備進入第三階段臨床試驗時，顯然這些成本將會增加。

Now from a perspective of OpEx the administrative costs will grow slightly, but we could expect that the Company will incur costs in R&D of somewhere around, overall costs I'm sorry, will be somewhere around between $12 million to $15 million once the study starts up for some of that being front-loaded for the normal deposits that are need to be made to get the consultants CROs and the like setup, which is why we under the current circumstances of us looking at a trial beginning in Q1, we've got cash into Q3 of '24.

現在，從營運支出的角度來看，管理成本將略有成長，但我們預計公司將在研發方面產生一定程度的成本，抱歉，一旦研究開始，總體成本將在 1200 萬至 1500 萬美元之間為了獲得顧問CRO 等類似設置所需的正常存款，我們需要預先支付一些費用，這就是為什麼我們在目前的情況下考慮從第一季開始進行試驗，我們已經24 年第三季獲得現金。

Which also gives us additional time to go out and look for business development deals. We have the ferret data, some out. We've had the versus the NCI triple data come out. We've had the docetaxel data come out. We've had the KOL meeting, so there has been a significant number of data readouts, and we're hopeful that that will be a catalyst for potential business development deals as well.

這也讓我們有更多的時間出去尋找業務發展交易。我們有雪貂數據，有些已經出來了。我們已經公佈了與 NCI 的三重數據對比。我們已經公佈了多西紫杉醇數據。我們召開了 KOL 會議，因此獲得了大量數據，我們希望這也將成為潛在業務開發交易的催化劑。

Thank you. Can I just ask you one follow-up question? So for fourth quarter '23, then you would expect OpEx to be similar to third quarter or would there be some ramp up for the data?

謝謝。我可以問你一個後續問題嗎？那麼，對於 23 年第四季度，您預計營運支出將與第三季度相似，或者數據會增加嗎？

There will be some ramp up in Q4 of this year. So we spent about $10.5 million in total in Q3. So my expectation would be around there or a little higher.

今年第四季將會有一些成長。因此，我們在第三季總共花費了約 1,050 萬美元。所以我的期望會在附近或更高。

Okay. Thank you.

好的。謝謝。

You're welcome.

不客氣。

Thank you. And our next question comes from the line of Mayank Mamtani with B. Riley Securities. Please proceed with your question.

謝謝。我們的下一個問題來自 Mayank Mamtani 和 B. Riley Securities 的聯繫。請繼續你的問題。

Good morning, and thanks for taking our questions and appreciate the comprehensive pipeline update. So maybe a high-level question quickly for you guys given 0101, prolong survival and the higher ORR, you seem to have be driven by 01ADC investor, one generally wonder if perhaps it makes sense to also evaluate red blend and whilst line on our should we think of triplet to be more in the ICI and since patients or maybe even being HPV agnostic. Could you just clarify how you're thinking about the positioning of these two programs? And then I have a couple of follow-ups.

早安，感謝您提出我們的問題並感謝全面的管道更新。因此，對於你們來說，考慮到 0101，延長生存期和更高的 ORR，你們似乎受到了 01ADC 投資者的推動，人們普遍想知道評估紅色混合物是否有意義，同時符合我們的應該我們認為三聯體更多出現在ICI 中，因為患者甚至可能對HPV 不可知。您能否解釋一下您是如何看待這兩個項目的定位的？然後我有一些後續行動。

Frank. If you're speaking, you may be on mute.

坦率。如果您正在說話，您可能處於靜音狀態。

Thank you very much, Mayank. I think you're absolutely right. We have seen highly encouraging survival data with PDS0101 as well as PDS01ADC as well as extremely encouraging ORR with the PDS01ADC. Now we have certainly considered the application of the PDS01ADC in the earlier line, ICI naive.

非常感謝你，瑪雅克。我認為你是完全正確的。我們看到 PDS0101 和 PDS01ADC 的生存數據非常令人鼓舞，而 PDS01ADC 的 ORR 也非常令人鼓舞。現在我們當然已經考慮過 PDS01ADC 在早期產品線的應用，ICI 很幼稚。

However, after talking to key opinion leaders in the field as well as the regulatory experts, it's evident that the survival and safety data generated with the doublet, presents the most straightforward regulatory pathway as well as the robust uptake if and when it becomes standard of care, right? With the doublet will also enable a more rapid potential approval path for early even early use.

然而，在與該領域的主要意見領袖以及監管專家交談後，很明顯，由 doublet 生成的生存和安全數據提供了最直接的監管途徑，並且如果它成為標準，就會得到強勁的採用。關心，對吧？雙峰還將為早期甚至早期使用提供更快速的潛在批准路徑。

Now when we look at the triple in the ICI resistant population, it also presents the quickest path to approval and potentially application in multiple HPV cancer indications. As you mentioned, it's an essentially tumor agnostic.

現在，當我們觀察 ICI 抗藥性族群中的三重時，它也提供了在多種 HPV 癌症適應症中獲得批准和潛在應用的最快途徑。正如您所提到的，它本質上與腫瘤無關。

This triple combination may then also subsequently find its way to an approval for use in ICI naive patients. So this is something we have actually seriously considered. But after talking to the experts in the field, the two options we're taking now appear to provide the quickest path to rapid approvals and uptake.

這種三重組合也可能隨後獲得批准用於 ICI 初治患者。所以這是我們實際上認真考慮過的事情。但在與該領域的專家交談後，我們現在採取的兩種選擇似乎提供了快速批准和採用的最快途徑。

I understood. Thank you for that clarification and then maybe drilling down on the doublet trial protocol. Are there any details on the SAP that you're able to share in terms of the target OS, differential you're going for against standard of care. I recognize you're talking about sites, but not a specific patient numbers, but just sort of it would be helpful to understand, what sort of hazard ratio, what sort of data on OS you're aiming for. And this is a related question, your [S] more translational biomarker data was actually quite novel in context of demonstrating CD8, T cell responses to selected tumor cells. I was wondering if there are any implications of that in terms of patient enrichment, our response assessment side of view that you could deploy in your late-stage development.

我明白了。感謝您的澄清，然後可能會深入研究雙重試驗方案。您是否可以分享有關 SAP 的任何有關目標操作系統的詳細信息，以及您要根據護理標準尋求的差異。我知道您談論的是站點，而不是具體的患者數量，但只是有助於理解您的目標是哪種風險比、哪種作業系統資料。這是一個相關的問題，您的[S]更多轉化生物標記數據實際上在展示 CD8、T 細胞對選定腫瘤細胞的反應方面相當新穎。我想知道這對豐富患者是否有任何影響，您可以在後期開發中部署我們的反應評估觀點。

Okay. Maynak, a lot of really good questions. So let me start with the biomarker data. So with the biomarker data, as you as you did mention, we're looking at a number of novel approaches to really understanding and documenting how PDS0101 is working and really documenting and clarifying the differentiation of our assets.

好的。 Maynak，很多非常好的問題。讓我從生物標記數據開始。因此，正如您所提到的那樣，利用生物標記數據，我們正在尋找一些新穎的方法來真正理解和記錄 PDS0101 的工作原理，並真正記錄和闡明我們資產的差異化。

So if you look at the data presented at ESMO, for example, looking at the poly functional CD8 T cells, confirming an increase in poly functionality was very important, but also understanding the kind of immunological profile that PDS0101 is promoting, for example, going from a TH2 biased to a TH1, TH1 being well documented to be better associated with strong CD8 T cell responses, right? And also showing that we have potential exit of the CD8 T cells from the blood to the tumor sites, right? showing the decline in circulating peripheral blood containing CD8 T cells. So we have that approach in that study in the PDS0101 KEYTRUDA.

因此，如果您查看 ESMO 上提供的數據，例如查看多功能 CD8 T 細胞，確認多功能的增加非常重要，但也要了解 PDS0101 正在促進的免疫學特徵，例如，從TH2 偏向TH1，TH1 有充分記錄表示與強CD8 T 細胞反應較好相關，對吧？並且還表明我們有可能將 CD8 T 細胞從血液中排出到腫瘤部位，對吧？顯示循環週邊血液中含有 CD8 T 細胞的下降。因此，我們在 PDS0101 KEYTRUDA 的研究中採用了這種方法。

Now, when you also look at what's been done in terms of biomarkers in the immunoserve study, but very complementary to what we seen with the PDS0101, KEYTRUDA study in the in the new research study what MD Anderson was looking at circulating tumor DNA, circulating tumor DNA is extremely important for a number of reasons, right?

現在，當您也查看免疫服務研究中在生物標記方面所做的工作時，這與我們在PDS0101 中看到的非常互補，MD 安德森癌症中心在新研究中觀察到的循環腫瘤DNA、循環中的KEYTRUDA 研究出於多種原因，腫瘤 DNA 極為重要，對吧？

If you look at cancer today, most patients don't die from the initial tumor of the initial cancer, they often die from micro metastatic cancer that remains after the initial treatment, right? And so being able to essentially eliminate the tumors from the pick, the patient's body becomes extremely important. And how do you know that your technology, your product is actually achieving that?

如果你看看今天的癌症，大多數患者不會死於初始癌症的初始腫瘤，他們經常死於初始治療後殘留的微轉移癌，對嗎？因此，能夠從根本上消除腫瘤，患者的身體就變得極為重要。你怎麼知道你的技術、你的產品確實達成了這個目標？

What we have seen now with our circulating tumor DNA in that study is the strong potential for PDS0101 to actually dramatically eliminate and reduce and eliminate the circulating tumor DNA, right at five weeks, 92% reduction versus 52% reduction with a standard of care.

我們現在在研究中看到的循環腫瘤 DNA 是 PDS0101 的強大潛力，能夠真正顯著消除和減少循環腫瘤 DNA，在五週內，減少 92%，而標準治療則減少 52%。

Md Anderson is extremely excited about that because they believe it has direct implications for patient survival and very importantly, recurrence after cancer, right? of that is it that is data that we will hopefully be expecting to see coming up in 2024, how that elimination of circulating tumor DNA correlates with recurrence of the cancer and survival of the patients.

安德森癌症中心對此感到非常興奮，因為他們相信這對患者的生存有直接影響，非常重要的是，對癌症後的復發有直接影響，對嗎？其中，我們希望在 2024 年看到數據，了解循環腫瘤 DNA 的消除與癌症復發和患者存活之間的關係。

Now what they also looked at a very innovative approach using cervical brushing to really quantify and understand the kinds of T cells that are actually accumulating in the patient's tumors, right? So we talked about the CD8 T cells in the blood and exiting the blood, but it's also important to understand what's happening in the tumor.

現在，他們也研究了一種非常創新的方法，使用子宮頸刷來真正量化和了解患者腫瘤中實際累積的 T 細胞類型，對嗎？我們討論了血液中和離開血液的 CD8 T 細胞，但了解腫瘤中發生的情況也很重要。

And what they also show was a really strong correlation between this elimination of circulating tumor DNA and accumulation targets and accumulation of these CD8 T cells within the patient's tumor. Once again, very different to date, most of our peers have looked at T cells in the circulating blood, looking at things like interferon gamma.

他們還表明，循環腫瘤 DNA 的消除和累積目標與患者腫瘤內這些 CD8 T 細胞的累積之間存在很強的相關性。迄今為止，與以往截然不同的是，我們的大多數同行都研究了循環血液中的 T 細胞，研究了乾擾素 γ 等物質。

But what we are showing here is that these T cells generated by the Versamune technology, actually do target, and accumulate in the patient's tumors. Right? Again, we have very complementary studies, which are in agreement with each other, which has given us a really good picture of how and why we've seen the results we see in these patients today.

但我們在這裡展示的是，這些由 Versamune 技術生成的 T 細胞實際上確實靶向並在患者的腫瘤中累積。正確的？同樣，我們有非常互補的研究，這些研究彼此一致，這讓我們很好地了解了我們今天在這些患者中看到的結果的方式和原因。

Now if you go to the triple combination, very similar studies have been performed by the National Cancer Institute in the triple combination, again, showing that very strong correlation between induction of HPV16 specific T cells and the clinical responses and also showing that this triple combination in addition to inducing strong tumor-specific multifunctional T-cells also induces an inflammatory immunological profile, which is strongly believed to suppress the tumor's ability to hide from the immune system, right?

現在，如果您進行三重組合，美國國家癌症研究所在三重組合中進行了非常相似的研究，再次表明HPV16 特異性T 細胞的誘導與臨床反應之間存在非常強的相關性，並且還表明這種三重組合除了誘導強大的腫瘤特異性多功能 T 細胞外，還誘導發炎免疫學特徵，人們強烈認為這會抑制腫瘤躲避免疫系統的能力，對吧？

And now we're getting all the information that helps us better understand how and why we've seen the kinds of results we've seen today in these patients even in the very difficult-to-treat patients.

現在，我們正在獲取所有信息，幫助我們更好地了解我們如何以及為何在這些患者（甚至是非常難以治療的患者）中看到今天所看到的各種結果。

So, now coming to your earlier question, which had to do with the design of the VERSATILE-003 trial. Now we have not made details of the clinical design public yet, but I can give you some insight. So how are we thinking about this?

那麼，現在回到您之前的問題，該問題與 VERSATILE-003 試驗的設計有關。現在我們還沒有公開臨床設計的細節，但我可以給你一些見解。那我們要如何思考這個問題呢？

The delta today is quite significant. When you look at the delta of what we see in the two year results versus what we see in the published data, we know that by far exceeds what we have to achieve for approval, but as a risk mitigation strategy in terms of our statistical design, what we are also looking at is we are also saying Well let's assume PDS0101 The patients in our control arm taking KEYTRUDA will do much better than KEYNOTE- 048. Right?

今天的三角洲相當重要。當您查看我們在兩年結果中看到的結果與我們在已發布數據中看到的差異時，我們知道這遠遠超出了我們必須實現的批准目標，但作為我們統計設計方面的風險緩解策略，我們也在關注的是，我們也在說，好吧，讓我們假設PDS0101 我們對照組中服用KEYTRUDA 的患者會比KEYNOTE-048 做得更好。對吧？

So in terms of our endpoints for the control arm, we are anticipating that there will be higher than KEYNOTE- 048, patient -- oncologists are getting more used to administering KEYTRUDA. They're getting better understanding of which patients may respond better. And so we have to assume that those patients are going to do better than has been published today.

因此，就控制臂的終點而言，我們預計會有高於 KEYNOTE-048 的終點，患者 - 腫瘤學家越來越習慣使用 KEYTRUDA。他們越來越了解哪些患者可能會有更好的反應。因此，我們必須假設這些患者的情況會比今天公佈的情況更好。

What we are also assuming in that design is that our patients in the study at multiple sites all over the world will not do as well as we've seen in VERSATILE-002. So we are also reducing that target and that risk mitigation allows us to overpower the study based upon what we've seen today and mitigate the risk that we will not get to that clinical endpoint right?

我們在該設計中也假設，我們在世界各地多個地點進行研究的患者的表現不會像我們在 VERSATILE-002 中看到的那樣好。因此，我們也在降低該目標，而風險緩解使我們能夠根據我們今天所看到的情況壓倒研究，並減輕我們無法達到臨床終點的風險，對嗎？

So we've taken those strategies into consideration just based upon the really large delta we seem to get today allows us to narrow that delta, but also be reasonable in terms of trial size and the power of the trial to successfully achieve those primary endpoints of overall survival.

因此，我們只是根據今天似乎獲得的巨大增量來考慮這些策略，這使我們能夠縮小該增量，但在試驗規模和試驗的能力方面也應合理，以成功實現這些主要終點總體生存率。

Mayank, and I hope that answers your question.

Mayank，我希望這能回答你的問題。

Yeah. No, very, very comprehensive, very helpful. And then lastly for Matt, just quickly on the strategic collaboration discussions are you able to describe qualitatively interest from strategics on doublet versus triplet? And how maybe recently data may have been from those discussions and are and also the full data set from your double had expected in second quarter. Would they want to see that mature analysis before of transacting or like kind of this layout, what sort of the variables that are there that impact a discussion like that? Thanks for taking our questions to mind.

是的。不，非常非常全面，非常有幫助。最後，對馬特來說，在策略合作討論中，您是否能夠定性地描述對雙聯和三聯策略的興趣？最近的數據可能來自這些討論，並且是來自您的雙重預期的第二季度的完整數據集。他們是否希望在交易之前看到成熟的分析或類似的佈局，有哪些變數會影響這樣的討論？感謝您考慮我們的問題。

So Mayank as you know going to be able to go. I'm not going to be able that quite.

所以，正如你所知，Mayank 能夠離開。我不會完全做到這一點。

you wanna take that one Frank?

你想帶走那個弗蘭克嗎？

Yes, I'll take that one. Yeah. So Mayank, as you know, I won't be able to go into very specific details as to what we are discussing. Our, however, the data that we have today, has been very helpful in clarifying certain things.

是的，我會接受那個。是的。所以 Mayank，如你所知，我無法詳細介紹我們正在討論的內容。然而，我們今天掌握的數據對於澄清某些事情非常有幫助。

So one of the key things that I mentioned over the last couple of earnings calls has been the fact that we are waiting to see the data from the VERSATILE-002 refractory arm. That data was very important because it was key. And given us insight into the specific role of PDS0101 or the contribution of PDS0101 in extending life in head and neck cancer patients.

因此，我在過去幾次財報電話會議中提到的關鍵事情之一是，我們正在等待查看 VERSATILE-002 耐火材料臂的數據。這些數據非常重要，因為它是關鍵。並讓我們深入了解 PDS0101 的具體作用或 PDS0101 在延長頭頸癌患者生命方面的貢獻。

And so looking at that combination of PDS0101 and KEYTRUDA in patients who have failed checkpoint inhibitors, the majority of which we know were on KEYTRUDA and still being able to extend those patients' lives significantly was very important for us to demonstrate and to get potential partners also comfortable. That okay PDS0101 is actually biologically active in this population and even seeing this expansion in even a much more difficult to treat population so that that was that was key.

因此，在檢查點抑制劑失敗的患者中觀察PDS0101 和KEYTRUDA 的組合，我們知道其中大多數患者都在使用KEYTRUDA，並且仍然能夠顯著延長這些患者的生命，這對於我們展示和尋找潛在合作夥伴非常重要也舒服。好吧，PDS0101 實際上在這個人群中具有生物活性，甚至在更難治療的人群中也看到了這種擴展，所以這是關鍵。

It was also important for us in the triple combination trial as I mentioned previously for us to have better understanding of what PDS0101 is doing in that combination because a lot of the questions we received both from investors and prospective partners is when the triple, how do we know which of these components is working and what is contributing to what right?

正如我之前提到的，這對我們在三重組合試驗中也很重要，讓我們更好地了解PDS0101 在該組合中的作用，因為我們從投資者和潛在合作夥伴那裡收到的許多問題是，當三重組合時，如何做我們知道這些組件中的哪些在起作用，以及哪些組件對什麼有貢獻？

So, now the role of PDS0101 becomes very clear, but with the data we have today, right? We also now see the critical role of PDS01ADC. And so now both components, both drugs have very clearly shown their biological activity and what is also very important is we look at VERSATILE-002 right? Refractory arm, no IL12, 0% confirmed objective response. ,

那麼，現在PDS0101的作用就變得非常清楚了，但是根據我們今天掌握的數據，對嗎？我們現在也看到了 PDS01ADC 的關鍵作用。所以現在兩種成分、兩種藥物都非常清楚地顯示出它們的生物活性，同樣非常重要的是我們看看 VERSATILE-002，對嗎？難治性手臂，無 IL12，0% 確認客觀緩解。 ,

If you add a low dose IL12, 5% confirmed objective response. If you go to a high dose IL12, 63% confirmed objective response. Very clear in terms of what's happening with IL12, right? So we all this data that is now available provides not just PDS by potential partners with confidence in the biological activity of our drugs. Right?

如果添加低劑量的IL12，5%證實了客觀反應。如果使用高劑量的 IL12，63% 證實了客觀反應。 IL12 的情況非常清楚，對嗎？因此，我們現有的所有數據不僅提供了潛在合作夥伴對我們藥物的生物活性充滿信心的 PDS。正確的？

In terms of and discussions, I'll say there are no issues with the current protocol, right? As you know, we have alignment with the FDA on the path forward. But what's happening with these discussions is not at all uncommon, and we believe that it is prudent to at least evaluate suggestions that a serious potential partner may have, even though there are no guarantees that the partnership will result when all is said and done, right?

在討論方面，我會說當前協議沒有問題，對吧？如您所知，我們在前進的道路上與 FDA 保持一致。但這些討論所發生的情況並不少見，我們認為，至少評估一個認真的潛在合作夥伴可能提出的建議是謹慎的，儘管不能保證當一切都說完了之後，合作關係就會產生，正確的？

But there are a number of typical things that we typically want to evaluate at this case, and we would not do this for every prospective partner suggestion we receive. However, I hope that gives you some flavor of what the data we've seen today and how it's impacting discussions that we are having.

但在這種情況下，我們通常想要評估許多典型的事情，我們不會對收到的每個潛在合作夥伴建議都這樣做。然而，我希望這能讓您了解我們今天看到的數據以及它如何影響我們正在進行的討論。

It does. Thank you for taking your questions and look forward to future updates.

確實如此。感謝您提出問題並期待未來的更新。

No, problem. Thanks a lot.

沒問題。多謝。

Thank you. Our next question comes from the line of Joe Pantginis with H.C. Wainwright. Please proceed with your question.

謝謝。我們的下一個問題來自 Joe Pantginis 和 H.C.溫賴特。請繼續你的問題。

Hi, good morning, everybody. Thanks for taking the questions. Two questions, please. So first 0101, wanted to ask about currently what you have ready to go followed by your intermediate near term needs and intermediate needs with regard to manufacturing.

嗨，大家早安。感謝您提出問題。請教兩個問題。首先，0101 想詢問您目前已準備好做什麼，然後是您在製造方面的中期近期需求和中期需求。

And then the second question is a little bit of the off the beaten path here because it's been nice to hear such the encouraging data updates from in 0101, but I wanted to ask about 0202, and the universal flu vaccine, you are sitting on what we consider to be a very strong asset profile and the data that you've accumulated to date. So other than the rhetorical answer of financial resources, how what could you envision being a development plan for that asset? Thanks.

然後第二個問題有點不尋常，因為很高興聽到 0101 中令人鼓舞的數據更新，但我想問一下 0202 和通用流感疫苗，你現在坐在什麼位置？我們認為您迄今為止積累的資產概況和數據非常強大。那麼，除了財務資源的口頭回答之外，您還能如何設想該資產的開發計畫？謝謝。

Hey, thanks a lot. Joe. I'll start with the first question in terms of what we have ready to go with PDS0101. So with PDS0101, we have done all the tech transfer. The material has been scaled up to our commercial process and the Phase 3 clinical product has already been successfully manufactured and released.

嘿，非常感謝。喬.我將從第一個問題開始，也就是我們為 PDS0101 做好了哪些準備。因此，對於 PDS0101，我們已經完成了所有技術轉移。該資料已擴大到我們的商業流程，三期臨床產品已成功製造和發布。

So in terms of clinical product that has been scaled up to the final process and has been successfully manufactured. We are there today. So the material is ready to go. We don't have any additional needs from the perspective of PDS0101 materials in order to run the Phase 3 clinical trial with either program VERSATILE-002 or the triple combination with PDS0202 as you mentioned, this is a program that we are quite excited about today, our resources, financial resources are really focused on the oncology programs. However.

因此，就臨床產品而言，已擴大到最終製程並已成功生產。我們今天就在那裡。這樣材料就準備好了。從 PDS0101 材料的角度來看，我們沒有任何額外的需求，以便使用 VERSATILE-002 方案或與 PDS0202 的三重組合進行 3 期臨床試驗，正如您提到的，這是一個我們今天非常興奮的項目，我們的資源、財政資源真正集中在腫瘤學項目。然而。

We have made significant progress also with this program. As you know, the data was presented in September at the European influenza conference that data from ferrets. Like ferrets been the gold standard for preclinical studies. So it was very important to be able to demonstrate that we can replicate the data that was generated in the mouse models in the ferrets, which are closest to humans in influencer.

我們在這個計劃上也取得了重大進展。如您所知，該數據是在 9 月的歐洲流感會議上公佈的，該數據來自雪貂。就像雪貂一樣，它是臨床前研究的黃金標準。因此，能夠證明我們可以在雪貂身上複製小鼠模型中產生的數據非常重要，因為雪貂在影響力方面最接近人類。

And again, all that work that has been done successfully. We've shown very similar levels or identical levels of broadly reactive neutralizing antibodies against multiple strains of the flu that was shown successfully infrared. We also showed and successful prevention of viral replication in the lungs when the animals were given the full doses of the H1, N1 virus. As well as protection against infection in the ferrets also. So we have shown we have shown very good translation.

再說一次，所有這些工作都已成功完成。我們已經展示了針對多種流感病毒株的廣泛反應性中和抗體的水平非常相似或相同的水平，並且在紅外線下成功顯示。我們也證明，當給動物注射全劑量的 H1、N1 病毒時，可以成功阻止病毒在肺部複製。還可以防止雪貂感染。所以我們已經證明我們已經展示了非常好的翻譯。

Now from PDS, it's perspective for us this is not surprising because again, even in our oncology products, we've shown very good translation from preclinical models to humans, right? And so we expected this the NIAID is extremely encouraged by the data that we've seen to date.

現在從 PDS 的角度來看，這對我們來說並不奇怪，因為即使在我們的腫瘤學產品中，我們也已經展示了從臨床前模型到人類的非常好的轉化，對嗎？因此，我們預計 NIAID 對我們迄今為止所看到的數據感到非常鼓舞。

And so we have had some discussions. We are still hopeful that we will get some notification sooner or later regarding the next steps, what we would envision or what we would like to see would be for this to go into at least the Phase 1/2 human clinical trial sometime next year and start generating the human data that can also replicate the kinds of broadly reactive neutralizing antibodies that we're seeing in the animal models and humans.

我們進行了一些討論。我們仍然希望我們遲早會收到有關後續步驟的通知，我們的設想或我們希望看到的情況是至少在明年某個時候進入 1/2 期人體臨床試驗，開始產生人類數據，這些數據也可以複製我們在動物模型和人類中看到的廣泛反應性中和抗體。

Hopefully and provide very important data on safety, as you know, with preventive vaccine safety is extremely important. We've seen very good safety profile today with PDS0101. So we do expect to see very similar safety with and this preventive vaccine. And then hopefully, depending on when in the year it's down, you get some data on actual prevention against an infection with the flu.

希望並提供非常重要的安全性數據，如您所知，預防性疫苗的安全性極為重要。今天我們已經看到 PDS0101 具有非常好的安全性。因此，我們確實希望看到這種預防性疫苗具有非常相似的安全性。然後希望，根據一年中流感下降的時間，您可以獲得一些有關實際預防流感感染的數據。

So we're very we're really hopeful, and we still own a very, very good discussions with NIAID. They've indicated that this is something they would like to move forward. And so we are waiting to learn what the next steps will be and what when those next steps will start.

因此，我們非常充滿希望，並且我們仍然與 NIAID 進行了非常非常好的討論。他們表示這是他們想要推進的事情。因此，我們正在等待了解下一步將是什麼以及這些後續步驟何時開始。

Appreciate the colors, Frank.

欣賞這些顏色，弗蘭克。

No problem.

沒問題。

Thank you. (Operator Instructions) Our next question comes from the line of Jim Molloy with Alliance Global Partners. Please proceed with your part with your questions.

謝謝。 （操作員說明）我們的下一個問題來自 Alliance Global Partners 的 Jim Molloy。請繼續您提出問題的部分。

Hello, this is Laura on for Jim. Thank you for taking the questions and congrats on your progress. So, you mentioned an upcoming trials for your preclinical PDS0103 candidates for you in the first half of next year. What are any other updates that you have for your preclinical, PDS0102 and 0104 candidates.

大家好，我是吉姆的勞拉。感謝您提出問題並祝賀您的進步。因此，您提到了明年上半年即將對您的臨床前 PDS0103 候選藥物進行試驗。您對臨床前、PDS0102 和 0104 候選藥物還有哪些更新？

Hi, Laura. Thanks for your question with PDS0103, as I mentioned, the goal is to start in the third and third quarter in the first half of next year. And so that is going to be done under our collaboration with NIH. right now, we are finalizing the CMC section.

嗨，勞拉。感謝您提出PDS0103的問題，正如我所提到的，目標是在明年上半年的第三季和第三季開始。這將在我們與美國國立衛生研究院 (NIH) 的合作下完成。現在，我們正在最後確定 CMC 部分。

We are finalizing the animal studies and looking at the new triple combination, which is potentially going to be very likely that the path we go down, that's being evaluated now in specific tumor models that we would want to include in the IND filing. So we are we are working towards an IND filing, hopefully in Q1 of next year to get this into the clinic, hopefully by the second quarter of next year.

我們正在完成動物研究，並研究新的三重組合，這很可能是我們所走的道路，現在正在特定的腫瘤模型中進行評估，我們希望將其納入 IND 申請中。因此，我們正在努力提交 IND 申請，希望在明年第一季將其投入臨床，希望在明年第二季之前。

With PDS0102 we are also working now on the tech transfer and the formulation development has been completed. Preclinical work has been completed with PDS0102 and just to remind just to remind the audience and who may still be on PDS0102 specifically addressing prostate cancer.

對於PDS0102，我們現在也進行技術轉讓，配方開發已經完成。 PDS0102 的臨床前工作已經完成，只是提醒觀眾以及可能仍在使用 PDS0102 專門治療前列腺癌的人。

So I'm sure you can see how that potentially lines up with what we're doing with docetaxel. There is the potential that we could include that to make a new triple combination. But the goal here with that program is to get that dual combination as rapidly as possible to commercialization. But there's potential for expansion in terms of even more difficult or latest treat cancer patients and decline of circulating tumor DNA using that PDS0102 assets in which the target is taught TARP.

所以我確信您可以看到這與我們對多西紫杉醇所做的事情有什麼潛在的聯繫。我們有可能將其納入新的三重組合。但該計劃的目標是盡快將這種雙重組合商業化。但使用 PDS0102 資產（其中目標是 TARP）在治療更困難或最新的癌症患者以及減少循環腫瘤 DNA 方面具有擴展潛力。

TARP has been found in about 90% of prostate cancers at all stages of the disease and about 50% of breast cancers. So that's an asset that we do anticipate hopefully getting into manufacturing sometime next year in 2024 to allow us to start to evaluate that asset also probably later in the year. But we will provide updates regarding what that and what we're doing with our process product program for potential partnerships.

TARP 已在約 90% 的各個階段的前列腺癌和約 50% 的乳腺癌中發現。因此，我們確實預計這項資產預計將在明年 2024 年的某個時候投入生產，以便我們也可能在今年稍後開始評估該資產。但我們將提供有關該內容以及我們正在為潛在合作夥伴的流程產品計劃所做的更新。

How we're going to move that forward, will provide some of more of those details later as the year goes by 2024, PDS0104, We have not yet made any additional progress with PDS0104. We really concentrated on PDS0101, 0102, 0103, at this point as well as PDS01ADC.

我們將如何推進這一進程，將在 2024 年晚些時候提供更多詳細信息，PDS0104，我們尚未在 PDS0104 方面取得任何額外進展。此時我們真正關注的是 PDS0101、0102、0103 以及 PDS01ADC。

Got it. Thank you for the clarity and also to form a question on alongside the data presented for immunotherapy. For your other, investigator initiated trial of PDS0101 this with the Mayo Clinic?

知道了。感謝您的澄清，並根據免疫療法提供的數據提出一個問題。對於您的其他人，研究者與 Mayo Clinic 啟動了 PDS0101 試驗？

Do you have any estimates as to when you might see a data announced here?

您對何時可以看到此處公佈的數據有任何估計嗎？

No. So with them with the Mayo Clinic and starting the Mayo Clinic, as I mentioned, that's and you mentioned that's another investigator initiated trial evaluating early-stage HPV16 positive oral cancer, neoadjuvant setting. We have been informed, as I mentioned, by the PI, but we hope to present preliminary data at a scientific meeting in the first half of 2024.

不。因此，正如我所提到的，他們與 Mayo Clinic 合作並啟動了 Mayo Clinic，這也是您提到的另一項研究人員發起的試驗，評估早期 HPV16 陽性口腔癌的新輔助治療設置。正如我所提到的，PI 已通知我們，但我們希望在 2024 年上半年的科學會議上提供初步數據。

And so we'll keep you updated as we learn more as to what conference that would be and what the exact timing would be, but we are hopeful that we'll see some data from, I would say, the first preliminary data from that trial, hopefully in the first half of 2024 and with immunotherapy.

因此，當我們更多地了解這將是什麼會議以及確切的時間安排時，我們將隨時向您通報最新情況，但我們希望我們能看到一些數據，我想說的是，來自該會議的第一個初步數據希望在 2024 年上半年進行試驗並採用免疫療法。

The investigators are extremely encouraged with the data that they've seen today. Based on what we've been told by Dr. Clark of MD Anderson, who leads this trial is actually planning on submitting interim results of the study for scientific publication and particularly the recent circulating tumor HPV DNA outcomes reported at Asco and the previously reported tracking and accumulation of multifunctional CD8 T cells in the tumors. And she also intends to update clinical response and survival data. So we are hopeful that we'll get an additional update on that trial in the near future.

研究人員對今天看到的數據感到非常鼓舞。根據領導這項試驗的 MD 安德森癌症中心的 Clark 博士告訴我們的情況，他實際上計劃提交該研究的中期結果以供科學發表，特別是 Asco 報告的最近循環腫瘤 HPV DNA 結果以及之前報告的跟踪以及多功能CD8 T 細胞在腫瘤中的累積。她還打算更新臨床反應和存活數據。因此，我們希望在不久的將來能夠獲得有關該試驗的額外更新。

Understood. Thank you for taking the questions.

明白了。感謝您提出問題。

Thanks a lot.

多謝。

Thank you. There are no other questions at this time. I'll turn the floor back, Dr. Bedu-Addo, for any final comment.

謝謝。目前沒有其他問題。貝杜-阿多博士，我將請大家發表最後的評論。

Thank you very much. So thank you to all for participating in our third quarter earnings conference call today. The progress made this quarter has been truly exciting. We remain enthusiastic about what lies ahead for the rest of this quarter and into 2024.

非常感謝。感謝大家今天參加我們的第三季財報電話會議。本季取得的進展確實令人興奮。我們仍然對本季剩餘時間和 2024 年的前景充滿熱情。

We have made significant strides towards our objective of developing groundbreaking therapies that transform cancer treatment. We are confident that our efforts will positively impact these patients with critical unmet medical need, leading to longer lives and improved quality of life. We appreciate your continued support and eagerly anticipate updating you on our accomplishments. Thank you very much again and have a wonderful day.

我們在開發突破性療法來改變癌症治療的目標方面取得了重大進展。我們相信，我們的努力將為這些醫療需求未被滿足的患者帶來正面影響，從而延長他們的壽命並提高生活品質。我們感謝您持續的支持，並熱切期待向您介紹我們的成就。再次非常感謝您，祝您有個愉快的一天。

Thank you. This concludes today's conference call. You may disconnect your lines at this time. Thank you for your participation.

謝謝。今天的電話會議到此結束。此時您可以斷開線路。感謝您的參與。