PDS Biotechnology Corp (PDSB) 2023 Q4 法說會逐字稿

Good morning, and welcome to PDS Biotech's call to discuss the company's year-end 2023 financial results and clinical strategy update conference call. (Operator Instructions) I would now like to turn the conference over to Tom Johnson with LifeSci Advisors.

早安，歡迎 PDS Biotech 來電討論公司 2023 年底財務業績和臨床策略更新電話會議。（操作員說明）我現在想將會議轉交給 LifeSci Advisors 的 Tom Johnson。

Please go ahead, sir.

請繼續，先生。

Thank you, operator, and good morning, everyone, and welcome to PDS Biotech's 2023 year-end results and Clinical strategy update call. Today, we will discuss financial results for the year ended December 31, 2023, and provide a business and clinical programs update this morning, the company issued a press release with these results for GE found under the Investor Relations section of the PDS Biotech website.

謝謝操作員，大家早安，歡迎參加 PDS Biotech 的 2023 年年終業績和臨床策略更新電話會議。今天，我們將討論截至2023 年12 月31 日的年度財務業績，並在今天早上提供業務和臨床計劃更新，該公司在PDS Biotech 網站的投資者關係部分下發布了一份新聞稿，其中包含GE的這些業績。

I'm joined on the call today by the following members of the company's management team, Dr. Frank Bedu-Addo, Chief Executive Officer; Lars Boesgaard, Chief Financial Officer; and Dr. Kirk Shepard, Chief Medical Officer. Dr. Bedu-Addo will begin with a corporate and clinical programs update. And then Mr. Boesgaard will review financial results for 2023. Following the company's prepared remarks, Dr. Shepard will join the call to help address questions from covering analysts.

今天，公司管理團隊的以下成員也加入了我的電話會議：執行長 Frank Bedu-Addo 博士；拉爾斯‧博斯加德 (Lars Boesgaard)，財務長；和首席醫療官 Kirk Shepard 博士。Bedu-Addo 博士將首先介紹公司和臨床項目的最新情況。然後 Boesgaard 先生將回顧 2023 年的財務表現。在公司發表準備好的演講後，謝潑德博士將加入電話會議，協助解答分析師提出的問題。

As a reminder, during this call, we will be making forward-looking statements, which are subject to various risks and uncertainties that could cause actual results to differ materially from these statements. Any such statements should be considered in conjunction with the cautionary statements in our press releases and risk factors discussed in our filings with the SEC, including our quarterly reports on Form 10 Q and annual report on Form 10-K and cautionary statements made during this call. Please assume no obligation to update any of these forward-looking statements or information.

提醒一下，在這次電話會議中，我們將做出前瞻性陳述，這些陳述受到各種風險和不確定性的影響，可能導致實際結果與這些陳述有重大差異。任何此類聲明應與我們新聞稿中的警告聲明以及我們向SEC 提交的文件中討論的風險因素結合考慮，包括我們的10 Q 表季度報告和10-K 表年度報告以及本次電話會議期間所做的警告聲明。請不承擔更新任何這些前瞻性聲明或資訊的義務。

Now I'd like to turn the call over to Dr. Bedu-Addo. Frank?

現在我想把電話轉給貝杜-阿多醫生。坦率？

Thank you, Tom, and good morning, everyone. I am pleased to be speaking with all of you today and to be joined by two new members of the PDS Biotech leadership team, large booth.

謝謝你，湯姆，大家早安。我很高興今天能與大家交談，並有 PDS Biotech 領導團隊的兩名新成員加入，大型展位。

Scott joined us last November as Chief Financial Officer.

Scott 去年 11 月加入我們，擔任財務長。

He is an experienced CFO with an impressive track record of guiding biotech companies to create strategic growth. We welcome his insights as well as his financial expertise and oversight as we continue to mature our business and advance our clinical programs in January of 2024, we also announced the appointment of Dr. Kirk Sheppard. Kirk is a distinguished board-certified medical oncologists and hematologists with more than 30 years of experience in the pharmaceutical industry.

他是一位經驗豐富的財務官，在指導生物技術公司實現策略成長方面擁有令人印象深刻的記錄。我們歡迎他的見解以及他的財務專業知識和監督，因為我們將在 2024 年 1 月繼續成熟我們的業務並推進我們的臨床項目，我們也宣布任命 Kirk Sheppard 博士。Kirk 是一位傑出的委員會認證的醫學腫瘤學家和血液學家，在製藥行業擁有 30 多年的經驗。

Most recently KIRK was Chief Medical Officer, Senior Vice President and Head of the Global Medical Affairs Oncology Business Group at ESI. We are particularly pleased to have KIRK on board as his wealth of oncology and clinical expertise will be invaluable as we begin to execute the updated clinical development strategy we will be discussing today. As Tom mentioned last, we'll walk you through our financial results for 2023 later on the call, and Kirk will be available to take questions.

KIRK 最近擔任 ESI 首席醫療官、高級副總裁兼全球醫療事務腫瘤業務組負責人。我們特別高興 KIRK 加入，因為當我們開始執行今天將討論的更新的臨床開發策略時，他豐富的腫瘤學和臨床專業知識將非常寶貴。正如湯姆最後提到的，我們將在稍後的電話會議上向您介紹 2023 年的財務業績，柯克將可以回答問題。

During the Q&A. session.

問答期間。會議。

So let's begin our fourth quarter of 2023 and recent weeks have been a busy and productive period for PDS Biotech during which we made significant advancements with our PDSO. one ADC., our IO 12 fused antibody-drug conjugate clinical programs, as well as our PDS. oh one oh one Phase two programs over this period, compelling data from several Phase two trials became available. This includes long-term survival data from the National Cancer Institute lead triple combination trial of PDSO. one ADC in combination with Versamune HPV., formerly known as PDSO. one O. one and an investigational immune checkpoint inhibitor for ICI., we also obtained data from our own versatile zero zero two study of Versamune HPV. and Keytruda. Collectively, these data have provided us with clarity regarding how our drug platform technology works in advanced cancer and have informed the strategic decision we announced today to advance this triple combination of Versamune HPVPDSO. one ADC and Keytruda in recurrent and or metastatic head and neck cancer also referred to as head and neck squamous cell carcinoma for HNSCC. This program will be our top clinical development priority in place of the previously planned versatile zero zero three trial.

因此，讓我們開始 2023 年第四季度，最近幾週對於 PDS Biotech 來說是忙碌而富有成效的時期，在此期間我們的 PDSO 取得了重大進展。一個 ADC、我們的 IO 12 融合抗體-藥物偶聯物臨床計劃以及我們的 PDS。哦一哦一第二階段計劃在此期間獲得了來自多個第二階段試驗的令人信服的數據。這包括來自國家癌症研究所主導的 PDSO 三重組合試驗的長期存活數據。一種 ADC 與 Versamune HPV（以前稱為 PDSO）組合。一種 O. 1 和一種用於 ICI 的研究性免疫檢查點抑制劑。和Keytruda。總的來說，這些數據使我們清楚地了解了我們的藥物平台技術如何在晚期癌症中發揮作用，並為我們今天宣布的戰略決策提供了信息，以推進 Versamune HPVPDSO 的三重組合。一種 ADC 和 Keytruda 治療復發性和/或轉移性頭頸癌（也稱為 HNSCC 的頭頸部鱗狀細胞癌）。該計劃將取代先前計劃的多功能零零三試驗，成為我們臨床開發的首要任務。

This decision and enables us to focus our resources on a regimen which we believe has the highest potential benefit to patients with head and neck cancer and the potential to drive shareholder value.

這項決定使我們能夠將資源集中在一種治療方案上，我們相信這種治療方案對頭頸癌患者俱有最大的潛在益處，並且有可能提高股東價值。

On today's call, we will walk you through the data that has driven this decision, discuss the careful vetting we've undertaken to confirm our approach and outline the advanced preparations on trial design and regulatory engagement. We've already begun to set the stage. I'll first review the critical limitations that remain in the use of immunotherapies to treat solid tumors.

在今天的電話會議上，我們將向您介紹推動這項決定的數據，討論我們為確認我們的方法而進行的仔細審查，並概述試驗設計和監管參與的高級準備工作。我們已經開始搭建舞台。我將首先回顧使用免疫療法治療實體瘤仍然存在的關鍵限制。

First, the innate or acquired resistance. These tumors have two immunotherapies, including immune checkpoint inhibitors or ICI and CAR T T cell approaches. These approaches all rely on activating T-cells to attack the cancer. They therefore attack the cancer from the outside. However, most advanced solid tumors houses their protection against the immune system in their inner core. These tumors can therefore prevent T-cells from recognizing or infiltrating the tumor. In addition, these tumors may be able to even activate any infiltrating T cells due to the presence of suppressive cytokine or inhibitory factors within the tumor.

首先，先天的或後天的抵抗力。這些腫瘤有兩種免疫療法，包括免疫檢查點抑制劑或 ICI 和 CAR T T 細胞方法。這些方法都依賴活化 T 細胞來攻擊癌症。因此，他們從外部攻擊癌症。然而，大多數晚期實體瘤在其內核中都具有針對免疫系統的保護作用。因此，這些腫瘤可以阻止 T 細胞辨識或浸潤腫瘤。此外，由於腫瘤內存在抑制性細胞因子或抑制因子，這些腫瘤甚至可能能夠活化任何浸潤性 T 細胞。

Second important limitation is that current immunotherapies have not demonstrated the ability to generate the right type and quantity of effective tumor infiltrating and tumor killing cells. Unlike what we have demonstrated with our Versamune platform to date, recent long-term survival results and clinical data provide clarity on the dual mechanism of action of combining PDSO. one ADC and Versamune and its potential to overcome most critical immuno oncology limitations.

第二個重要的限制是，目前的免疫療法尚未證明能夠產生正確類型和數量的有效腫瘤浸潤和腫瘤殺手細胞。與我們迄今為止透過 Versamune 平台所證明的不同，最近的長期存活結果和臨床數據清楚地表明了聯合 PDSO 的雙重作用機制。一種 ADC 和 Versamune 及其克服最關鍵的免疫腫瘤學限制的潛力。

The insights into the PDSO. one ADC mechanism of action provided by this recent data clarify the potential of this drug therapy in combination with Versamune HPV. and an immune checkpoint inhibitor, PDSO. one ADC utilizes an antibody that binds to DNA found in the inner core of the tumor and therefore delivering the IL-12 into the internal compartment of the tumor, the IL-12 once within the tumor limits the presence of inhibitory factors within the tumor, thereby weakening the tumors and defenses against the immune system. Versamune HPV. simultaneously generates a powerful T-cell attack on the exposed or less protected tumor resulting in compelling anti-tumor responses, which we will discuss shortly. The data shows that with this combination, the mechanism uniquely acts on both the inside and outside of the tumor data was announced last November from the Phase two National Cancer Institute led triple combination trial for the treatment of recurrent and all metastatic HPV16 positive.

對 PDSO 的見解。最近的數據提供的一種 ADC 作用機制闡明了該藥物療法與 Versamune HPV 聯合使用的潛力。和免疫檢查點抑制劑 PDSO。一種 ADC 利用一種與腫瘤內核中發現的 DNA 結合的抗體，從而將 IL-12 遞送到腫瘤的內部區室中，IL-12 一旦進入腫瘤內，就會限制腫瘤內抑制因子的存在，從而削弱腫瘤和免疫系統的防禦能力。Versamune HPV。同時對暴露或保護較少的腫瘤產生強大的 T 細胞攻擊，從而產生引人注目的抗腫瘤反應，我們將很快討論這一點。數據顯示，透過這種組合，該機制獨特地作用於腫瘤的內部和外部。陽性。

I see I naive and I see a resistant cancers. This included head and neck cancer among other tumor types and provided proof of concept of the mechanism of action and support for prioritizing the triple combination in the ICI. resistance group, the 12 months overall survival rate was 72% and the median overall survival was approximately 20 months with current approaches.

我看到我天真，我看到一種抵抗癌症。這包括其他腫瘤類型中的頭頸癌，並提供了作用機制的概念證明，並為 ICI 中優先考慮三重療法提供了支持。抗藥性組的 12 個月總存活率為 72%，採用目前的方法，中位總存活期約為 20 個月。

The 12-month overall survival rate in HPV positive ICI resistant cancer is approximately 30%, and median overall survival is only 3.4 months at 63%. Overall response rate or ORR. was observed in patients with the optimal dose of PDSO. one ADCs published data to date suggest are of less than 20% in ICA resistant HPV-positive head and neck cancer. In the ICI. naive group, 75% of patients remain alive at 36 months, and therefore, the median overall survival was not reached with immune checkpoint inhibitors published results show a 36 month survival rate of approximately 20%.

HPV 陽性 ICI 抗藥性癌症的 12 個月總存活率約為 30%，中位總存活期僅 3.4 個月，為 63%。總體緩解率或 ORR。在PDSO最佳劑量的患者中觀察到。迄今為止，一項 ADC 公佈的數據表明，ICA 抗藥性 HPV 陽性頭頸癌的比例不到 20%。在ICI中。初治組中，75%的患者在36個月時仍存活，因此，免疫檢查點抑制劑未達中位總存活期，已發表的結果顯示36個月存活率約為20%。

Overall response rate of 75% was seen in patients treated with the triple combination with a complete response rate of 38% published or are of less than 40% is seen with immunotherapeutic agents with the triple combination responses were seen in all HPV positive tumor types.

在接受三重療法治療的患者中，整體緩解率為75%，已公佈的完全緩解率為38%；而在所有HPV 陽性腫瘤類型中，免疫治療藥物的完全緩解率為40% 以下，三聯療法的緩解率在所有HPV 陽性腫瘤類型中均可見。

These data are further supported by our robust clinical data set in over 430 patients treated with either Versamune HPV. for PBSO. one ADC for the combinations, including over 110 head and neck cancer patients to date. Importantly, with respect to safety, we have seen acceptable tolerability in over 300 patients treated with PDSO. one ADC and in over 170 patients with Versamune HPV. today. Additionally, the National Cancer Institute has completed a detailed dose optimization study for PDSO. one ADC. based on safety and clinical response, which is a critical consideration for the FDA.

這些數據得到了我們對超過 430 名接受 Versamune HPV 治療的患者的強大臨床數據集的進一步支持。對於PBSO。一種針對該組合的 ADC，迄今已涵蓋 110 多名頭頸癌患者。重要的是，就安全性而言，我們在 300 多名接受 PDSO 治療的患者中發現了可接受的耐受性。一名 ADC 和超過 170 名 Versamune HPV 患者。今天。此外，美國國家癌症研究所也完成了 PDSO 的詳細劑量優化研究。 1 個 ADC。基於安全性和臨床反應，這是 FDA 的重要考慮因素。

This large database of patients provides a robust clinical dataset that validates the potential efficacy and safety of our platforms, which we believe supports our decision to prioritize our Versamune PDSO. one ADC platform in combination with Keytruda based on the totality of data generated to date from versatile zero zero two and the National Cancer Institute lead triple combination study, our triple combination trial to be progressed will therefore consist of Versamune HPVPDSO. one, ADC and Keytruda. We engaged the FDA regarding our decision and the FDA has provided clear guidance on clinical study design and regulatory pathway for the triple combination.

這個大型患者資料庫提供了強大的臨床數據集，可驗證我們平台的潛在功效和安全性，我們相信這支持我們優先考慮 Versamune PDSO 的決定。一個 ADC 平台與 Keytruda 相結合，基於多功能零零二迄今為止產生的全部數據和國家癌症研究所主導的三聯組合研究，因此我們即將進行的三聯組合試驗將包括 Versamune HPVPDSO。一、ADC和Keytruda。我們就我們的決定與 FDA 進行了接觸，FDA 為三聯療法的臨床研究設計和監管途徑提供了明確的指導。

We also engaged with top US and EU key opinion leaders to confirm interest in the triple combination and participation in a clinical trial. We are pleased to announce that Dr. Catherine price of Mayo Clinic, who is also an investigator on diverse styles. The residual two trial will be the lead investigator in the planned pivotal trial of the triple combination.

我們還與美國和歐盟的頂級關鍵意見領袖進行了接觸，以確認對三重組合和參與臨床試驗的興趣。我們很高興地宣布梅奧診所的 Catherine Price 博士，她也是多種風格的研究者。剩下的兩項試驗將成為計劃中的三重組合關鍵試驗的主要研究者。

We are also conducting rigorous evaluation of the competitive landscape in both IC IO naive and ICI resistant head and neck cancer. This careful research takes time, but we are taking the necessary steps to ensure that our decision is in the best interest of patients and our shareholders. We intend to move strategically and aggressively to advance the triple combination into a pivotal trial by initially addressing the rapidly growing unmet medical need in recurrent metastatic HPV16 positive head and neck cancer. We strongly believe that this approach has the potential to rapidly establish the combination of PDSO. one ADC and Versamune as a transformative oncology platform.

我們也正在對 IC IO 初治和 ICI 抗藥性頭頸癌的競爭格局進行嚴格評估。這項仔細的研究需要時間，但我們正在採取必要的步驟，以確保我們的決定符合患者和股東的最佳利益。我們打算策略性地、積極地採取行動，透過先解決復發性轉移性 HPV16 陽性頭頸癌中快速增長的未滿足的醫療需求，將三重組合推進到關鍵試驗中。我們堅信這種方法有潛力快速建立 PDSO 組合。 one ADC 和 Versamune 作為變革性腫瘤學平台。

The data suggest that the triple combination may result in a significant improvement in overall survival rates for patients who currently lack an effective treatment option. We are deeply grateful to our patients who participate in our trials and to our collaborators who continue to show immense confidence in our platforms and who has been instrumental in working with PDS Biotech to achieve what we now believe are potential significant advances in cancer treatments.

數據表明，三聯療法可能會顯著提高目前缺乏有效治療選擇的患者的整體存活率。我們非常感謝參與我們試驗的患者以及我們的合作者，他們繼續對我們的平台表現出巨大的信心，並在與PDS Biotech 合作以實現我們現在認為的癌症治療方面潛在的重大進展方面發揮了重要作用。

With that, I will turn it over to Lars for a review of our financial results. Lars?

這樣，我會將其轉交給拉斯，以審查我們的財務表現。拉爾斯？

Thanks, Frank, and good morning, everyone. I look forward to engaging with you as we advance the clinical program that Frank just presented.

謝謝弗蘭克，大家早安。我期待與您合作，推進弗蘭克剛剛介紹的臨床計劃。

Turning to our financial results, net loss for the year ended December 31, 2023, was approximately $42.9 million or $1.39 per basic and diluted share compared to a net loss of $40.9 million or $1.43 per basic share and diluted share for the year ended December 31, 2022, higher net loss was primarily the result of increased operating loss and increased net interest expense.

轉向我們的財務業績，截至2023 年12 月31 日止年度的淨虧損約為4,290 萬美元，或每股基本股和稀釋股1.39 美元，而截至12 月31 日止年度的淨虧損為4,090 萬美元，或每股基本股和稀釋股1.43 美元2022年，淨虧損增加主要是由於經營虧損增加和淨利息支出增加。

Our research and development expense for the year ended December 31, 2023 decreased to $27.8 million compared to $29.4 million for the year ended December 31, 2022. The decrease of $1.7 million was primarily attributable to the $10 million purchase of the rights to PDS. one EDC. in 2022, partially offset by an increase in clinical costs of $6.1 million and an increase in personnel cost of $2.1 million as a reminder, we entered into an exclusive worldwide license for PDS. one ADC. in late 2022 for consideration of $5 million in cash and $5 million in company shares.

截至2023年12月31日止年度，我們的研發費用減少至2,780萬美元，截至2022年12月31日止年度為2,940萬美元。減少 170 萬美元主要是因為花費 1,000 萬美元購買了 PDS 的權利。一個 EDC。提醒一下，到 2022 年，我們獲得了 PDS 的全球獨家許可，部分抵消了 610 萬美元的臨床成本增加和 210 萬美元的人員​​成本增加。 1 個 ADC。 2022年底，以500萬美元現金和500萬美元公司股票為代價。

General and administrative expenses for the year ended December 31, 2023, increased to $15.3 million compared to $12.2 million for the year ended December 31, 2022, the $3.1 million increase was primarily attributable to an increase in personnel costs of $1.5 million and an increase in personnel and professional fees, $1.6 million.

截至 2023 年 12 月 31 日止年度的一般及行政費用增加至 1,530 萬美元，而截至 2022 年 12 月 31 日止年度則為 1,220 萬美元，增加 310 萬美元主要是由於人事費用增加 150 萬美元以及人員和專業人員費用，160 萬美元。

Total operating expenses for the year ended December 31, 2023 were $43 million, an increase of approximately 3.3% compared to $41.7 million in total operating expenses for the year ended December 31, 2022, net interest expense increased to $1.3 million for the year ended December 31, 2023, compared to [$0.4 million] for the year ended December 31, 2022 this change was due to higher interest rate interest expense related to the company's notes payable, which was partially offset by higher interest income on our bank deposits.

截至2023年12月31日止年度的總營運支出為4,300萬美元，較截至2022年12月31日止年度的總營運支出4,170萬美元增加約3.3%，截至12月31日止年度的淨利息支出增加至130萬美元與截至2022年12月31日的年度[40萬美元]相比，截至2023年12月31日，此變更是由於與公司應付票據相關的利率利息支出增加，但部分被我們銀行存款利息收入的增加所抵銷。

During the fourth quarter of 2023, we raised approximately $10.5 million in net proceeds from our at-the-market sales agreement.

2023 年第四季度，我們從市場銷售協議中籌集了約 1,050 萬美元的淨收益。

In conclusion, our cash balance as of December 31, 2023 was $56.6 million. Our annual report, which will be filed within a few days, will contain a going concern opinion, reflecting substantial doubt about our ability to meet our obligations for 12 months following the filing of the annual report. Based on our currently available cash resources and cash flow projections, we believe that without commencing a pivotal clinical trial and without our notes payable being called by the lenders, our current cash balance is sufficient to fund our operations and research and development programs into the fourth quarter of 2025.

總之，截至 2023 年 12 月 31 日，我們的現金餘額為 5,660 萬美元。我們將在幾天內提交的年度報告將包含持續經營意見，反映出對我們在提交年度報告後 12 個月內履行義務的能力的重大懷疑。根據我們目前可用的現金資源和現金流量預測，我們相信，在不開始關鍵臨床試驗且貸款人不催收應付票據的情況下，我們當前的現金餘額足以為我們的營運和研發項目提供第四個季度的資金。

With that, I'll turn the call over to the operator for a Q&A session.

這樣，我會將電話轉給接線生進行問答環節。

(Operator Instructions) Louise Chen, Cantor Fitzgerald.

（操作員說明）Louise Chen，Cantor Fitzgerald。

Hi, good morning, everyone. This is Carly on for Louise Chen, and thank you for taking our questions. Our first question is, given you're prioritizing PDSO. one ADC. triple combo study offer versatile zero zero three. How are you thinking OpEx management differently for the rest of the year as a result of the switch?

嗨，大家早安。我是路易絲·陳 (Louise Chen) 的卡莉 (Carly)，感謝您回答我們的問題。我們的第一個問題是，鑑於您優先考慮 PDSO。 1 個 ADC。三重組合研究提供多功能的零零三。由於這項轉變，您對今年剩餘時間的營運支出管理有何不同看法？

And secondly, as we're thinking about the rest of this year and into towards 2025, what are your biggest milestones or data readouts in the next 12 to 18 months?

其次，當我們考慮今年剩餘時間和 2025 年時，未來 12 到 18 個月內最大的里程碑或數據讀數是什麼？

Thank you so much.

太感謝了。

Hi Carvey, thanks for that.

嗨卡維，謝謝你。

Question.

問題。

Could you please go over the first one again, I lost the last part of the first question of Yes, essentially we are talking about is your you guys are prioritizing the agency triple combo versus knows who is different theories? And how are you guys thinking about OpEx differently? Or is it going to be similar? And just wanted to get your color on that. Thank you.

您能再看一遍第一個問題嗎？你們對營運支出的看法有何不同？或者說會是類似的嗎？只是想得到你的顏色。謝謝。

Okay, thanks a lot, Carvey. We also answer the second part of the question first, and then I'll hand the OpEx portion to Lars to address. So in terms of our milestones for 2024, as you know, where there are a number of programs that we are simultaneously running in parallel with them with our our lead programs with a triple combination and versatile.

好的，非常感謝，卡維。我們也先回答問題的第二部分，然後我會把OpEx部分交給Lars來解決。因此，就我們 2024 年的里程碑而言，如您所知，我們正在與我們同時運行的許多專案以及我們具有三重組合和多功能性的主導專案。

There is there are two we do expect for ourselves.

我們確實對自己有兩個期望。

There is there are two that we will have an update sometime in the second or early early part of third quarter on where the trial is to date. As such, we've completed recruitment in that trial and we are hopeful that we'll be able to give updates on survival in the 0.002 trial.

有兩個我們將在第二季或第三季初的某個時間更新目前的試驗進度。因此，我們已經完成了該試驗的招募，我們希望能夠提供 0.002 試驗中生存率的最新資訊。

As you also may be aware, we have the immunotherapy trial that's being run at MD Anderson Cancer Center. That's looking at locally advanced cervical cancer, and we have some updates in November, but we expect this year in the second half of this year that we will have an update the clinical update specifically, so response rate, cell survival and potentially long term survival of those patients whose data was presented last year.

您也可能知道，我們正在 MD 安德森癌症中心進行免疫治療試驗。這是針對局部晚期子宮頸癌，我們在 11 月有一些更新，但我們預計今年下半年我們將具體更新臨床更新，因此反應率、細胞存活率和潛在的長期存活率去年提交數據的患者。

And so that will be a very, very important update that we would be expecting in the second half of this year. And of course, we also have the trial ongoing at the Mayo Clinic, which is the new adjuvant trial of PDSO. one O. one monotherapy and PDS oh one oh one to switch router in and in our early stage oral cancer, we have not had any data from that trial yet, but we are hopeful that sometime the second half of this year, we will have the preliminary preliminary data we released on them on the for that trial.

因此，這將是我們預計在今年下半年進行的非常非常重要的更新。當然，我們也在梅奧診所正在進行試驗，這是 PDSO 的新輔助試驗。一個 O. 單一療法和 PDS 哦一哦一在我們的早期口腔癌中切換路由器，我們還沒有從該試驗中獲得任何數據，但我們希望今年下半年的某個時候，我們將有我們在該試驗中發布了有關它們的初步初步數據。

So those are the key updates that we could potentially expect this year.

這些是我們今年可能期待的關鍵更新。

And we are also planning to move our PTS oh one oh three program into the clinic. So we are looking to file the IND for PDS oh one, oh three, obviously in the second half of this year and the inflammation that we have obtained recently regarding how our assets are working becomes critical in designing that trial into and also finalizing the combination for that trial where again, we expect to utilize the PDSONADC. Versamune combination in that in that program also.

我們也計劃將 PTS 哦一哦三計畫轉移到診所。因此，我們希望提交 PDS 的 IND 哦一哦三，顯然是在今年下半年，我們最近對我們的資產如何運作產生的不滿對於設計試驗和最終確定組合變得至關重要對於該試驗，我們再次希望利用PDSONADC。Versamune 組合在那方案中也。

So those could be key updates that we could be expecting this year from PDS.

因此，這些可能是我們今年 PDS 所期待的關鍵更新。

And last, I'll hand over to you to address the operating cost for 2024.

最後，我將交給您解決 2024 年的營運成本問題。

Thanks, Frank, and thanks for your question, Kartik. So we'll be filing all of our key in a few days. And so it will it will be clear from that for right now, you can see you'll see that we incurred an operating burn of approximately $8 million per quarter. And as also stated in the pre-prepared remarks, without initiating the triple combination from a pivotal study. We expect that burn to continue through the first two to three quarters of 2024 as we wrap up versus hot oh two and the after you probably see a slight decrease in that quarterly burn. And I should probably also mention that during the first quarter, our through the first quarter of 2024, we pulled down approximately $19 million under the ATM. So that, of course, also bolsters our current cash holdings.

謝謝弗蘭克，也謝謝你的提問，卡蒂克。因此，我們將在幾天內歸檔所有密鑰。因此，從目前來看，您會發現我們每季的營運消耗約為 800 萬美元。正如預先準備好的評論中所述，沒有從關鍵研究中啟動三重組合。我們預計這種燃燒將持續到 2024 年的前兩到三個季度，因為我們即將結束，與熱的哦二季度相比，之後您可能會看到季度燃燒略有下降。我或許也應該提到，在第一季（截至 2024 年第一季），我們透過 ATM 提取了約 1,900 萬美元。當然，這也增加了我們目前的現金持有量。

Got it thank you so much.

明白了，非常感謝。

(Operator Instructions) Mayank Mamtani, B. Riley Securities.

（操作員指示）Mayank Mamtani，B. Riley 證券。

Please see if there are questions, the mining team.

有問題請挖礦團隊看看。

Thanks for taking our questions and appreciate the comprehensive update in the sense, sensible strategy to it. Can you please clarify the 38% CRM triplet has been confirmed by resist, and there's going to be another update to that in 2024 that could be informative to how you think of your next study for the triplet? And maybe maybe just a related question, what steps remain in finalizing the registration-enabling study for the triplet and is there an end of Phase 2 meeting that you feel you prepared for? Or is there some additional work you can do given the earlier on the call that you have in your earlier study has now changed to Keytruda? And then I have a quick follow-up.

感謝您提出我們的問題，並讚賞我們的全面更新，以及明智的策略。您能否澄清一下，38% CRM 三元組已被抗蝕劑證實，並且 2024 年將有另一次更新，這可能會為您如何看待您的下一個三元組研究提供資訊？也許只是一個相關的問題，在完成三胞胎的註冊支援研究方面還需要採取哪些步驟，以及您覺得您準備好第二階段會議的結束了嗎？或者，考慮到您先前研究中的電話現在已更改為 Keytruda，您還可以做一些額外的工作嗎？然後我會進行快速跟進。

Mayank, thanks a lot for your question. So starting with the triple combination and the complete responses so that the triple combination study that was led by the National Cancer Institute has been completed. So that study that study is now final the results that we went through today are the final results from that study?

Mayank，非常感謝你的問題。因此，從三重組合和完整反應開始，這樣由國家癌症研究所領導的三聯組合研究就已經完成。那麼這項研究現在已經是最終結果了，我們今天看到的結果是研究的最終結果嗎？

Right.

正確的。

So the 38% confirmed response rates are confirmed objective response rate. And as I mentioned, the the follow-up for the naive patients was three years.

因此，38%的確認答覆率是確認的客觀答覆率。正如我所提到的，初次接受治療的患者的追蹤期為三年。

And so one of the key things that we were looking for was not only the data from the burst out there for refractory arm of the versatile receiver to study to understand how the dual combination is working, but also to really understand the long term survival in the triple combination.

因此，我們要尋找的關鍵事情之一不僅是多功能接收器的耐火臂的爆發數據，以研究了解雙重組合的工作原理，而且要真正了解長期生存三重組合。

So we had really good survival for year one and the first 17 months, what we need to understand would we what would we get if it's a significant drop off after one to two years? Or would this be a durable response and these patients continue to survive. And what we saw was that all patients were alive at two years remained alive at three years. That was very important but what was also very important was the safety Vice us.

因此，我們在第一年和前 17 個月的生存率非常好，我們需要了解的是，如果一到兩年後存活率大幅下降，我們會得到什麼？或者這會是一種持久的反應，而這些患者會繼續生存。我們看到的是，所有患者在兩年時仍存活，三年後仍存活。這非常重要，但同樣非常重要的是我們的安全。

As you may know, our PDSO. one ADC. is an IL. 12 based antibody drug conjugate. And in the past, recombinant IL-12 have seen significant toxicities. And so one of the key reasons that we needed additional data was really to confirm the safety profile of our IO. 12 antibody drug conjugate in Tulsa to really confirm that it is significantly different from the recombinant IL. 12 that have been evaluated in the past and that continue to be evaluated to date, right?

如您所知，我們的 PDSO。 1 個 ADC。是一個IL。 12 基抗體藥物偶聯物。過去，重組 IL-12 曾出現顯著的毒性。因此，我們需要額外資料的關鍵原因之一實際上是為了確認我們 IO 的安全狀況。 12抗體藥物綴合物在塔爾薩真正證實它與重組IL有顯著不同。 12 個過去已經過評估並且至今仍在繼續評估的，對吧？

So the safety data from the three over 300 patients that we've evaluated today was very critical in forming this decision also really confirming that safety profile and tolerable tolerability in these patients, we've taken the IL. 12 antibody ADC.

因此，我們今天評估的 300 多名患者的安全性數據對於做出這項決定非常​​關鍵，也確實證實了這些患者的安全性和可耐受性，我們採取了 IL。 12抗體ADC。

So that was again very, very important in this decision making process also.

因此，這在這個決策過程中也非常非常重要。

Now what was also very important is what you just brought up. Is there a clear regulatory regulatory pathway for the triple combination? And so that was why we initiated discussions with the FDA to get feedback from the FDA in terms of what they would want to see in a clinical design of PDSO. one 83, Versamune HPV. and Keytruda with PDSO. one O. one, Keytruda forming the basis for that program. We've seen very good survival, impressive survival with just PDSO. one and one and Keytruda based upon the quality of T cells that we generating and now adding the PDSO. one 83.

現在同樣非常重要的是你剛才提到的。三聯是否有明確的監管監管路徑？因此，我們開始與 FDA 進行討論，以獲取 FDA 的回饋，以了解他們希望在 PDSO 的臨床設計中看到什麼。 1 83，Versamune HPV。和帶有 PDSO 的 Keytruda。一、一，Keytruda 構成了這個計畫的基礎。我們已經看到了非常好的存活率，僅使用 PDSO 就能存活下來，令人印象深刻。一和一和 Keytruda 是基於我們生成的 T 細胞的質量，現在添加了 PDSO。一 83.

On top of that, we'll overcome overcome the tumor's defenses right. And so we have that discussion with the FDA last month and the FDA has given us very clear guidance on what they would want to see in the clinical design and so what we're currently doing is implementing the feedback from the FDA. And then once we have done that, we would want to get that alignment with the FDA that okay.

最重要的是，我們將克服腫瘤的防禦能力。因此，我們上個月與 FDA 進行了討論，FDA 就他們希望在臨床設計中看到的內容向我們提供了非常明確的指導，因此我們目前正在做的是落實 FDA 的反饋。一旦我們做到了這一點，我們就會希望與 FDA 保持一致。

We've taken these your concentration, your TAM, your advice and your Advair into consideration here with the trial and get alignment with the FDA and adoption and we will make will then make that on the protocol and publicly available. But we would I would hate to go into saying exactly what the design is until we have gotten that alignment with the FDA based upon the feedback they gave us.

我們在試驗中考慮了您的濃度、您的 TAM、您的建議和您的 Advair，並與 FDA 保持一致並採用，然後我們會將其納入方案並公開發布。但在我們根據 FDA 提供的回饋與 FDA 達成協議之前，我不想詳細說明設計是什麼。

But that's the development process that we've gone through to date.

但這就是我們迄今為止所經歷的開發過程。

You've got it. Very helpful. And then on the opportunity set has on like what specific indication you're looking at your lead? Is it the same population that you have this data or are you looking at this more broadly in HPV-positive solid tumor types, which there are many if you can just categorize the broader opportunity set and also like how you get there in terms of different trial you would need that would be helpful.

你已經明白了。非常有幫助。然後，關於機會集，您正在尋找潛在客戶的具體跡像是什麼？您擁有這些數據的人群是否相同，或者您是否更廣泛地關注 HPV 陽性實體瘤類型，如果您可以對更廣泛的機會集進行分類，並且喜歡如何根據不同的方式實現這一點，那麼有很多類型您需要的試用會很有幫助。

And thanks again for taking the question

再次感謝您提出問題

Mayank, but that's a really good question.

Mayank，但這是一個非常好的問題。

So we have done extensive market research talking to key opinion leaders to really understand the potential in both ICA naive and ICA resistant patients from all the information we're getting. The K will see this as potentially very important in both the big unmet their unmet needs in both the ICA naive and ICA resistant patient population.

因此，我們與關鍵意見領袖進行了廣泛的市場研究，從我們獲得的所有資訊中真正了解 ICA 初治患者和 ICA 抗藥性患者的潛力。K 將認為這對於 ICA 初治和 ICA 抗藥性患者群體中未滿足的巨大需求可能非常重要。

As you know, currently, the response rates in ICA naive only about 20%, a very significant unmet need there in the ICL resistant practically nothing is really working in those patients. Our focus initially guided by the FDA is to focus on head and neck cancer rather than going broadly into all types of HPV-associated cancers which is what we were initially thinking about.

如您所知，目前 ICA 的反應率僅為 20% 左右，ICL 抗藥性的一個非常重要的未滿足需求實際上對這些患者沒有任何作用。我們最初在 FDA 的指導下重點關注頭頸癌，而不是廣泛關注所有類型的 HPV 相關癌症，而這正是我們最初考慮的。

But what we what we discuss with the FDA and the guidance we've been given is let's focus first on head and neck cancer which is where we've generated the bulk of our data to date, right? Over 110 patients in head and head-and-neck cancer patients have been treated with our product today so we have really good confidence around the head and neck cancer patients and the NCI. trial. Of course, we went beyond head and neck cancer to look at other HPV types where we saw responses equally good responses across the board.

但我們與 FDA 討論的以及我們得到的指導是，讓我們首先關注頭頸癌，這是我們迄今為止產生大量數據的地方，對嗎？今天，已有超過 110 名頭頸癌患者接受了我們的產品治療，因此我們對頭頸癌患者和 NCI 充滿信心。審判。當然，我們不僅關注頭頸癌，還研究了其他 HPV 類型，我們在這些類型中看到了同樣良好的反應。

And so the way we envision this is, let's first focus on the biggest market and the most rapidly growing market, which is the head and neck cancer space, get that done and then potentially progress from there into the other HPV. cancer tumor types. But our initial focus is going to be specifically recurrent metastatic head and neck cancer.

因此，我們設想的方式是，讓我們首先關注最大的市場和成長最快的市場，即頭頸癌領域，完成該目標，然後可能從那裡進展到其他 HPV。癌症腫瘤類型。但我們最初的重點將是特別是復發性轉移性頭頸癌。

Thank you for taking my questions.

感謝您回答我的問題。

(Operator Instructions) James Molloy, Alliance Global Partners.

（操作員說明）James Molloy，Alliance Global Partners。

Yes, good morning. Thank you for taking my questions. So I apologize for the change in the fall. Sometimes the sort of first half oh three Phase three combo for Keytruda, HPV-positive head and neck squamous cell CPINE. patients that trials now shelved or that trial is now ongoing, but added you're adding in the oh one KDC. diff formerly called oh three oh one.

是的，早安。感謝您回答我的問題。因此，我對秋季的變化表示歉意。有時是 Keytruda、HPV 陽性頭頸鱗狀細胞 CPINE 的前半程或三期三期組合。試驗現已擱置或試驗正在進行中的患者，但補充說您正在添加哦一個 KDC。 diff 以前稱為「哦三哦一」。

James, thanks for your question.

詹姆斯，謝謝你的問題。

Diverse styles, the receiver three, we're not performing versatile zero zero three. So based upon the information we have today, our goal as a company is to is to provide to the patients the drug in combination that we believe provides them with the best opportunity for managing their disease. And today, based upon the information we have generated and our understanding of the mechanism by which these assets work, we believe that the triple combination is what provides these patients with the best opportunity to manage the disease.

款式多樣，接收器三，我們不是表演多才多藝的零零三。因此，根據我們今天掌握的信息，我們作為一家公司的目標是向患者提供我們相信為他們提供控制疾病的最佳機會的組合藥物。今天，根據我們產生的資訊以及我們對這些資產發揮作用的機制的理解，我們相信三重組合為這些患者提供了控制疾病的最佳機會。

But also what's very important for us based upon the key opinion leader research is which combination is really going to put PDS Biotech and a dominant leadership position in head and neck cancer. And that comes down to where oncologists believe the combination has the best opportunity to help their patients tend to continue to help their patients survive long term.

但根據關鍵意見領袖的研究，對我們來說非常重要的是哪種組合真正能讓 PDS Biotech 在頭頸癌領域佔據主導地位。歸根結底，腫瘤學家認為這種組合最有機會幫助他們的患者繼續幫助他們的患者長期生存。

But when you look at if you look at all those angles in terms of the potential market domination potential for the patients, it comes down to the triple combination. And so that is the decision we have made.

但當你從所有這些角度考慮患者潛在的市場主導潛力時，你會發現這歸結為三重組合。這就是我們所做的決定。

It's not to move forward with Versalis the reserve to the retail pressure at the ILILDC. to that combination as the best opportunity and the best combination for the patients and also for market market success.

這並不是為了應對 ILILDC 零售壓力的 Versalis 儲備。將該組合視為患者以及市場成功的最佳機會和最佳組合。

Okay so the wearable market domination later, forgetting the trial's first, I think a versatile oh two data came out of that was that the Keytruda with HPV-positive HUDC. 16 positive ad next Fermacell combination with Keytruda was best in the CPI. naive, and that's why versus oh three was going to go forward in the naive in the last guidance we had was in the was for back in our November, October first patient by year, but obviously that's done oh three's wrapped up. It's done. It's not going forward.

好吧，後來可穿戴市場佔據主導地位，忘記了第一個試驗，我認為從中得出的一個多功能的哦兩個數據是帶有 HPV 陽性 HUDC 的 Keytruda。 16 個正面的廣告接下來 Fermacell 與 Keytruda 的組合在 CPI 中表現最佳。天真，這就是為什麼在我們去年 11 月、10 月的第一個患者的最後指導中，對抗 oh 3 將在天真中前進，但顯然這已經完成了 oh 3 已經結束了。完成了。它不會繼續前進。

Then on the triple combo oh one plus the commercial checkpoint inhibitor plus the ADC. for CPI. refractory patients. The plan had been for that that was going to be for the cigar refractories.

然後是三重組合，喔一加上商業檢查點抑制劑加上 ADC。對於消費者物價指數。難治性患者。該計劃原本是針對雪茄耐火材料的。

That trial still going forward against that.

該審判仍在繼續進行中。

So running on having triple combo with Hanmi with the NIH for me to answer that development going forward, correct.

因此，我將繼續與 Hanmi 和 NIH 進行三重組合，以回答未來的發展，正確的。

So now rather than having two separate trials, one with the Double Eagle in line with the triplet with, if you recall, the triplet had an investigational immune checkpoint inhibitor, right?

因此，現在不是進行兩項單獨的試驗，而是一項雙鷹試驗與三聯體試驗一致，如果您還記得的話，三聯體有一種研究性免疫檢查點抑制劑，對嗎？

And so the versatile zero zero two with the doublet, what we saw was extremely compelling long-term survival data.

因此，帶有雙合體的多功能零零二，我們看到的是極其引人注目的長期生存數據。

We have 74% survival at two years when we look at the brand, but one of the key and that was in CPI. naive patients, not when there's real naive, correct.

當我們觀察品牌時，我們的兩年存活率為 74%，但關鍵之一是 CPI。幼稚的病人，不是真正幼稚的時候，對的。

So when you move to the refractory patients, so this is very important because if you recall back with some of the data that we've mentioned over the last couple of earnings calls that we really needed to get that data in the resistant patients to really understand the impact of the various components, right? And so with that data in the refrac in the refractory patients with versatile, there was similar to what we found was, again, prolonged prolonged survival.

因此，當你轉向難治性患者時，這非常重要，因為如果你回想起我們在過去幾次財報電話會議中提到的一些數據，我們確實需要將難治性患者的數據真正了解各個組件的影響，對吧？因此，根據多才多藝的難治性患者的驗光數據，與我們發現的相似的是，再次延長了生存期。

But 0% objective responses, right? So PDS, the T cell induction was really leading to prolong survival of these patients, even though they weren't seen prolonged tumor shrinkage. Now when you compare that with what we found in the triple combination, where we then have the low dose IL-12 and the higher dose IL-12 with a low dose IL-12, we've seen very strong correlation with what we saw with the doublet, very weak objective responses with the higher dose IL-12, we're seeing dramatically improved objective responses and also improved survival. What's the when you look at those two together. So that data was very informative for us in really understanding the role of each of those components. And that was also critical into what drove that decision.

但客觀反應為 0%，對嗎？因此，PDS，T 細胞誘導確實延長了這些患者的生存期，儘管他們沒有看到腫瘤長期縮小。現在，當您將其與我們在三重組合中發現的結果進行比較時，我們有低劑量的IL-12 和較高劑量的IL-12 與低劑量的IL-12，我們發現與我們所看到的有非常強的相關性透過使用較高劑量 IL-12 的雙重、非常弱的客觀反應，我們發現客觀反應顯著改善，且存活率也得到提高。當你把這兩個人放在一起看時，你會發現什麼？因此，這些數據對於我們真正了解每個組件的作用非常有用。這對於推動這項決定也至關重要。

Let's say we have to provide our patients with the best opportunity in the by adding the IL. 12 until that doublet, which has shown a really good safety profile, right? We saw really good safety profile with PDSO. one O. one and Keytruda, but even even better results than even Keytruda monotherapy, which I explained earlier on as to why we believe we've seen though safety was very high safety and then adding the IL. 1283 funds off of that validated combination, right? And so that's that's how these have come together, how that data has actually led us to this decision. So this is really very simply put a data driven decision that's led us to this point where we've now merged the two trials into into one trial.

假設我們必須透過添加 IL 為患者提供最好的機會。 12 直到那件雙層衣服，它表現出了非常好的安全性，對吧？我們看到 PDSO 的安全性非常好。一 O.一和 Keytruda，但甚至比 Keytruda 單一療法更好，我之前解釋過為什麼我們相信我們已經看到安全性非常高，然後添加 IL。 1283 從這個經過驗證的組合中獲得資金，對吧？這就是這些數據如何結合在一起的，這些數據實際上如何引導我們做出這個決定的。因此，這實際上是一個數據驅動的決策，使我們現在將兩個試驗合併為一個試驗。

Okay.

好的。

Fair enough.

很公平。

But rather the lessons learned from the two trials into one,

而是從兩次試驗中學到的教訓合而為一，

Maybe the last question for me then.

也許是我的最後一個問題。

Thank you for clarifying that versus the Phase two combo trial, RPSO. one ADC. plus docetaxel in metastatic metastatic cancer cancer and prostate cancer with the NCI. It's a Phase two trial that's still ongoing?

感謝您澄清這一點與第二階段組合試驗 RPSO 的比較。 1 個 ADC。加多西他賽治療轉移性癌症和攝護腺癌（NCI）。這是仍在進行的第二階段試驗嗎？

Yes.

是的。

So we have a number of other trials ongoing at the National Cancer Institute.

因此，我們在國家癌症研究所正在進行許多其他試驗。

So currently, as PDS as a company, we are 100% focused on moving this triple combination into the pivotal trial.

因此，目前，作為 PDS 公司，我們 100% 專注於將這種三重組合推向關鍵試驗。

However, our collaboration with NC. is still ongoing. And based upon today, one of the key, if you look at what we're looking at there in prostate cancer at Mach one positive cancers, liver cancer, combining PDSO. one ADC with other standards of care, the strategy there is we understand how Versamune is working. We understand that versus inducing tumor-specific T cells.

然而，我們與 NC 的合作。仍在進行中。基於今天，關鍵之一是，如果你看看我們在馬赫一陽性癌症、肝癌中觀察到的前列腺癌，結合 PDSO。一種 ADC 與其他護理標準，我們的策略是了解 Versamune 的工作原理。我們知道這與誘導腫瘤特異性 T 細胞不同。

We also know that not every cancer has a checkpoint inhibitor as a standard of care. So what's now very important for us to understand is how our IL-12 ADC works with other standards of care. That then allows us to very rapidly progress into pivotal trials with a triple for some of those other cancers for which checkpoint inhibitors may not be the standard of care. So those trials are ongoing. They have been done as an IT prostate cancer trial with docetaxel was Phase 2 trial.

我們也知道，並非每種癌症都有檢查點抑制劑作為護理標準。因此，現在對我們來說非常重要的是了解我們的 IL-12 ADC 如何與其他護理標準一起使用。這使得我們能夠非常迅速地進入針對檢查點抑制劑可能不是標準治療的其他一些癌症的三聯關鍵試驗。所以這些試驗正在進行中。他們已經完成了一項使用多西紫杉醇的 IT 前列腺癌試驗，這是 2 期試驗。

The advanced locally advanced prostate cancer trial in combination with radiation therapy is also ongoing and the hepatic infusion and pump and study in liver cancer is also ongoing as well as the study encompasses sarcoma. So all of those studies are still ongoing under the NCI. collaboration, while we focus 100% on our triple combination and getting that two to finish.

局部晚期前列腺癌與放射治療相結合的試驗也在進行中，肝癌的肝臟輸注和泵送以及研究也在進行中，並且該研究涵蓋了肉瘤。因此，所有這些研究仍在 NCI 下進行。合作，而我們 100% 專注於我們的三重組合並完成這兩個。

Great thank you for your questions.

非常感謝您的提問。

No problem.

沒問題。

Thank you. I am showing no further questions. I'll turn it back to Dr. Bedu-Addo for closing remarks.

謝謝。我沒有提出任何進一步的問題。我將把它轉回給貝杜-阿多博士做總結發言。

Thank you very much.

非常感謝。

And I would before we leave, I would like to express our gratitude again to all our patients who have participated in our trials to all our collaborators as well as our shareholders and also to my colleagues and our employees at PDS Biotech, whose contributions have been essential in getting PDS Biotech to where we are today with really strong potential to take a key step to make these key advances in cancer treatment.

在我們離開之前，我想再次向參與我們試驗的所有患者、我們的所有合作者、我們的股東以及我的同事和 PDS Biotech 的員工表示感謝，他們的貢獻對於PDS Biotech 取得今天的成就至關重要，它具有非常強大的潛力，可以採取關鍵步驟，在癌症治療方面取得這些關鍵進展。

Thank you very much again for all your time today. And I wish you all a wonderful day.

再次非常感謝您今天抽出寶貴的時間。祝大家有美好的一天。

Thank you very much.

非常感謝。

This will conclude today's conference. You may disconnect your lines at this time, and thank you for your participation.

今天的會議到此結束。此時您可以斷開線路，感謝您的參與。