Imunon Inc (IMNN) 2025 Q1 法說會逐字稿

Good morning. My name is Dave, and I will be your operator today. At this time, I would like to welcome you to the Imunon's first quarter 2025 financial results conference call. (Operator Instructions)

早安.我叫戴夫，今天我將擔任您的接線生。現在，我歡迎您參加 Imunon 2025 年第一季財務業績電話會議。（操作員指示）

I would now like to turn your call over to Peter Vozzo of ICR Healthcare Investor Relations, representative for Imunon. Please go ahead.

現在，我想將您的電話轉給 ICR 醫療保健投資者關係部的 Peter Vozzo（Imunon 代表）。請繼續。

Thank you, Dave. Good morning, everyone, and welcome to Imunon's first quarter 2025 financial results and business update conference call.

謝謝你，戴夫。大家早安，歡迎參加 Imunon 2025 年第一季財務業績和業務更新電話會議。

During today's call, management will be making forward-looking statements regarding Imunon's expectations and projections about future events. In general, forward-looking statements can be identified by words such as expects, anticipates, beliefs or other similar expressions. These statements are based on current expectations that are subject to a number of risks and uncertainties, including those set forth in the company's periodic filings with the Securities and Exchange Commission. No forward-looking statements can be guaranteed, and actual results may differ materially from such statements.

在今天的電話會議中，管理層將就 Imunon 對未來事件的期望和預測做出前瞻性陳述。一般而言，前瞻性陳述可以透過預期、預期、信念或其他類似表達來識別。這些聲明是基於目前的預期，受多種風險和不確定因素的影響，包括公司定期向美國證券交易委員會提交的文件中所述。我們不能保證任何前瞻性陳述，實際結果可能與此類陳述有重大差異。

I also caution that the content of this conference call is accurate only as the date of this live broadcast, May 12, 2025. Imunon undertakes no obligation to revise or update comments made during this call, except as required by law.

我也提醒您，本次電話會議的內容僅在本次直播的日期即 2025 年 5 月 12 日準確。除非法律要求，否則 Imunon 不承擔修改或更新本次電話會議中發表的評論的義務。

With that said, I would like to turn the call over to Dr. Stacy Lindborg, President and Chief Executive Officer. Stacy?

話雖如此，我想將電話轉給總裁兼執行長史黛西林德伯格博士。史黛西？

Thank you, Peter, and good morning, everyone. Joining me on this call is Dr. Douglas V. Faller, Imunon's, Chief Medical Officer: and Dave Gaiero, our Interim Chief Financial Officer, who will review our financial results for the first quarter of 2025. Michael Tardugno, the Executive Chairman of our Board and Khursheed Anwer, our Chief Scientific Officer are also both on the line and will be available for Q&A.

謝謝你，彼得，大家早安。和我一起參加這次電話會議的還有道格拉斯 V 博士。Faller，Imunon 的首席醫療官；以及我們的臨時財務長 Dave Gaiero，他將審查我們 2025 年第一季的財務業績。我們的董事會執行主席 Michael Tardugno 和首席科學官 Khursheed Anwer 也在線，並將接受問答。

I want to start by saying that we may be close for the first time to unlocking the power of interleukin-12 to effectively treat cancer in one of the worst forms, ovarian cancer. Our work in developing treatments for ovarian cancer, a disease that continues to challenge scientists and clinicians and researchers, underscores our commitment to addressing unmet medical needs and driving long-term value.

首先我想說，我們可能首次接近釋放白血球介素-12 的力量，以有效治療最嚴重的癌症之一—卵巢癌。我們致力於開發卵巢癌治療方法，卵巢癌是一種持續挑戰科學家、臨床醫生和研究人員的疾病，凸顯了我們致力於解決未滿足的醫療需求和推動長期價值的承諾。

I'm amazed at the number of discussions I've had since joining Imunon in both personal and professional settings where people have shared impact from ovarian cancer at a close and personal level. Its devastation has no limits in taking the lives of women, young and old, in their prime. We continue to make significant strides towards our goal of transforming the treatment landscape for women diagnosed with advanced ovarian cancer.

自從加入 Imunon 以來，我在私人和專業場合中進行的討論次數讓我感到驚訝，人們在近距離和個人層面上分享了卵巢癌的影響。它的破壞力是無窮的，奪走了正值青春年華的婦女、老少的生命。我們繼續朝著改變晚期卵巢癌女性治療狀況的目標邁出重要一步。

To that end, I'm pleased to report that we have initiated the first clinical site in our Phase 3 pivotal study of Imunon-001. If the results from our highly successful Phase 2 study are replicated in Phase 3, patients and doctors may potentially have a meaningful life extending therapy that recruits and empowers body's immune system to effectively target this disease.

為此，我很高興地報告，我們已經啟動了 Imunon-001 第三階段關鍵研究的第一個臨床站點。如果我們非常成功的第 2 階段研究的結果在第 3 階段得到複製，患者和醫生就有可能獲得一種有意義的延長生命的治療方法，這種治療方法可以招募和增強人體的免疫系統來有效地針對這種​​疾病。

Our Phase 3 study, known as OVATION 3, is being recognized by the medical community as a critical step towards the goal of delivering a new frontline treatment for women with limited options and unmet urgent medical needs. This recognition is exemplified by the acceptance of our new OVATION 2 results for an oral presentation at the upcoming ASCO Annual Meeting and for publication in the peer-reviewed journal Gynecologic Oncology. It also underscores the scientific community's strong and historic evidence of Imunon-001's anti-cancer potential. We believe we have much to offer the future of oncology treatment, and I hope you are as excited as we are.

我們的 3 期研究（OVATION 3）得到了醫學界的認可，被認為是朝著為選擇有限和緊急醫療需求未得到滿足的女性提供新的一線治療目標邁出的關鍵一步。這項認可體現在我們的新 OVATION 2 研究結果被接受在即將召開的 ASCO 年會上進行口頭報告，並在同行評審期刊《婦科腫瘤學》上發表。這也強調了科學界對 Imunon-001 抗癌潛力的強有力和歷史證據。我們相信我們可以為腫瘤治療的未來做出很多貢獻，我希望您和我們一樣興奮。

Now, I'd like to report on our recent progress and review our clinical and regulatory status of Imunon-001. We continue to work with our trial investigators to begin enrolling participants, all of whom have shown unwavering interest in the Phase 3 trial and are committed to advancing the study. The confirmatory Phase 3 trial OVATION 3 will assess the efficacy of Imunon-001, plus the standard-of-care versus the standard-of-care, which is neoadjuvant and adjuvant chemotherapy alone.

現在，我想報告我們最近的進展並回顧 Imunon-001 的臨床和監管狀況。我們繼續與試驗研究人員合作開始招募參與者，所有參與者都對第三階段試驗表現出堅定的興趣，並致力於推進這項研究。驗證性 3 期試驗 OVATION 3 將評估 Imunon-001 加上標準治療與標準治療（即單獨的新輔助和輔助化療）的療效。

The standard-of-care for women who are newly diagnosed and treatment naive is paclitaxel and carboplatin chemotherapy, both neoadjuvant and adjuvant to interval debulking surgery. The study will enroll women at least 18 years of age newly diagnosed with advanced ovarian cancer. Study participants will be randomized 1:1, and there will be a subgroup of women positive for homologous recombination deficiency, HRD, which, as many of you will know, includes the familiar mutations BRCA1 or BRCA2.

對於新診斷且未接受治療的女性，標準治療方法是紫杉醇和卡鉑化療，包括新輔助化療和間隔減瘤手術的輔助化療。該研究將招募年齡至少 18 歲、新診斷為晚期卵巢癌的女性。研究參與者將以 1:1 的比例隨機分配，其中有一組女性對同源重組缺陷 (HRD) 呈陽性，正如你們許多人所知，這包括熟悉的 BRCA1 或 BRCA2 突變。

Participants within this sub-group will receive PARP inhibitors as part of standard maintenance therapy. The primary endpoint of the study is overall survival or OS. Secondary endpoints include surgical response score, chemotherapy response score, clinical response and time to second-line treatment.

該亞組中的參與者將接受 PARP 抑制劑作為標準維持治療的一部分。研究的主要終點是總體存活期或 OS。次要終點包括手術反應評分、化療反應評分、臨床反應和第二線治療時間。

The study will also assess several exploratory endpoints including quality of life measures, which will aid as we engage in payer and pricing discussions in the future, as we entertain approvals and access around the world. The advantage of overall survival as the primary endpoint is that it is a definitive endpoint. There will be no need for a second confirmational study to support approval. And if results are positive, the Phase 3 trial is also expected to support EU registration as a direct result of the selection of the overall survival of the primary endpoint.

該研究還將評估幾個探索性終點，包括生活品質指標，這將有助於我們在未來參與付款人和定價討論，以及在世界各地獲得批准和准入。以整體生存期作為主要終點的優點在於它是一個確定的終點。無需進行第二次確認研究來支持​​批准。而且如果結果是正面的，該3期試驗也有望支持歐盟註冊，因為直接選擇了總體存活期作為主要終點。

And you'll recall that we have orphan status established in Europe along with US Orphan Drug Designation. The initial core set of clinical trial sites currently activating are highly encouraged by Imunon-001's data and are enthusiastic about OVATION 3. These include sites that were part of both the Phase 1 OVATION 1 study and the Phase 1/2 OVATION 2 study. And we're excited to bring new sites on board to accelerate enrollment of the trial. The strength of our data is the key point of discussion, and we believe it will drive surgeons' interest and patient recruitment.

您可能還記得，我們​​在歐洲建立了孤兒藥地位，並獲得了美國孤兒藥稱號。目前正在啟動的初始核心臨床試驗點受到 Imunon-001 數據的極大鼓舞，並對 OVATION 3 充滿熱​​情。其中包括參與第 1 階段 OVATION 1 研究和第 1/2 階段 OVATION 2 研究的站點。我們很高興能引進新的站點來加速試驗的招募。我們的數據的強度是討論的重點，我們相信它將推動外科醫生的興趣和患者的招募。

There is optimism that Imunon-001 could potentially be a new product on the horizon and reset the standard-of-care for the frontline treatment of women newly diagnosed with advanced ovarian cancer if the safety and efficacy from OVATION 2 are confirmed in Phase 3.

人們樂觀地認為，如果 OVATION 2 的安全性和有效性在第 3 階段得到證實，Imunon-001 可能會成為即將問世的新產品，並重新設定新診斷為晚期卵巢癌的女性的一線治療標準。

We have a strategy and statistical plan which allows for a 500-patient trial in an all-comer population of newly diagnosed patients, as well as a plan to focus on a 250-patient sub-group defined by a biomarker identifying patients who are HRD positive. Both are strong options and have 95% power or higher, and both are capable of supporting an FDA approval for Imunon-001.

我們有一個策略和統計計劃，可以在所有新診斷患者群體中進行 500 名患者的試驗，同時還有一個計劃，重點關注透過識別 HRD 陽性患者的生物標記定義的 250 名患者亞組。兩者都是強有力的選擇，具有 95% 或更高的功效，並且都能夠支持 FDA 對 Imunon-001 的批准。

As we shared in our last call, we will focus initially on the HRD positive sub-group defined by a biomarker through a central lab. This highly cost-effective strategy allows us to enroll half the number of patients with an opportunity to achieve a readout sooner. We expect the study budget will be approximately 40% lower than the full study budget and could read out two years earlier.

正如我們在上次電話會議中所分享的，我們將首先關注透過中央實驗室由生物標誌物定義的 HRD 陽性亞群。這種極具成本效益的策略使我們能夠招募一半的患者，並有機會更快地獲得讀數。我們預計該研究的預算將比全部研究預算低約 40%，並且可能提前兩年完成。

This population represents one half of the neoadjuvant ovarian cancer market and would be an important advancement for patients. We would likely trigger a broadening of the inclusion criteria at a later date budget permitting to reach the 500 patient all-commerce trial. Our strategy includes an interim analysis at high probability for success milestones.

該族群佔新輔助卵巢癌市場的一半，對患者來說將是重要的進步。我們可能會在以後的預算允許的情況下擴大納入標準，以進行 500 名患者的全商業試驗。我們的策略包括對成功里程碑進行高機率的中期分析。

As we advance Imunon-001 in the Phase 3 OVATION 3 trial, we do not want its achievements in OVATION 2 to go unnoticed. As previously announced, data from the OVATION 2 study will be reviewed in an oral presentation during ASCO's Annual Meeting next month. Dr. Premal Thaker, who is Interim Chief of Gynecologic Oncology. David & Lynn Mutch, Distinguished Professor of Obstetrics & Gynecology, also Director of Gynecologic Oncology Clinical Research all at Washington University School of Medicine. She will lead the discussion in the oral presentation.

隨著我們在第 3 階段 OVATION 3 試驗中推進 Imunon-001，我們不希望它在 OVATION 2 中取得的成就被忽視。正如先前宣布的那樣，OVATION 2 研究的數據將在下個月的 ASCO 年會上以口頭報告的形式進行回顧。Premal Thaker 醫師是婦科腫瘤科臨時主任。大衛和林恩·穆奇 (David & Lynn Mutch) 是華盛頓大學醫學院婦產科傑出教授，也是婦科腫瘤臨床研究主任。她將在口頭報告中主導討論。

As I mentioned earlier, review of the full data from OVATION 2 will be published in the highly esteemed journal Gynecologic Oncology on June 3, being released simultaneous to the ASCO presentation. Having our data presented in two of the premier global platforms in gynecologic oncology underscores both the critical need to develop new therapies to treat ovarian cancer as well as the strength and potential of Imunon's TheraPlas platform technology.

正如我之前提到的，OVATION 2 的完整數據回顧將於 6 月 3 日發表在備受推崇的期刊《婦科腫瘤學》上，與 ASCO 報告同時發布。我們的數據在婦科腫瘤學領域的兩個全球頂級平台上展示，既凸顯了開發治療卵巢癌的新療法的迫切需要，也凸顯了 Imunon 的 TheraPlas 平台技術的優勢和潛力。

With that, I'd like to turn the call over to Dr. Douglas Faller, who will discuss the Phase 3 OVATION 3 study, including key points from his recent and ongoing discussions with study investigators as we initiate sites. Douglas?

接下來，我想將電話轉給道格拉斯·法勒博士，他將討論第三階段 OVATION 3 研究，包括他最近和正在進行的與研究調查員的討論中的要點，以及我們啟動站點時進行的討論。道格拉斯？

Thank you, Stacy. This is clearly a very exciting time for Imunon. In addition to the presentation of the results from our OVATION 2 trial at an oral session of ASCO in a few weeks and the simultaneous journal publication which Stacy mentioned, we've also been invited to present new translational data from the OVATION 2 trial at the International ESMO Gynecological Conference in June.

謝謝你，史黛西。對 Imunon 來說，這顯然是一個非常令人興奮的時刻。除了幾週後在 ASCO 的口頭會議上展示我們的 OVATION 2 試驗結果以及 Stacy 提到的同時期刊出版物之外，我們還受邀在 6 月份的國際 ESMO 婦科會議上展示 OVATION 2 試驗的新轉化數據。

The new data that we will present demonstrate that Imunon-001 technology performs exactly as it was designed, delivering highly potent IL-12 gene therapy directly to the site of the tumor while keeping systemic exposure to IL-12 extremely low. This is the proprietary biochemical basis for both Imunon's anti-cancer activity and just as important, its safety.

我們將展示的新數據表明，Imunon-001 技術的性能與設計完全一致，能夠將強效的 IL-12 基因治療直接輸送到腫瘤部位，同時保持全身對 IL-12 的暴露量極低。這是 Imunon 抗癌活性以及同樣重要的安全性的專有生化基礎。

We initiated the first clinical site in our registrational OVATION 3 trial last week with the second site to be initiated in two days. More site initiations are planned in the coming weeks. It is gratifying to me as a clinician and informative to note that these leading hospitals and internationally known principal investigators were also major participants in OVATION 2. Their enthusiasm actually their insistence for joining OVATION 3 speaks to their belief in the safety and potential benefit of Imunon-001 in the women they care for.

我們上週啟動了註冊 OVATION 3 試驗的第一個臨床站點，第二個站點將在兩天後啟動。未來幾週內計劃啟動更多站點。作為一名臨床醫生，我很高興並很高興地註意到這些領先的醫院和國際知名的首席研究員也是 OVATION 2 的主要參與者。他們的熱情實際上是他們堅持加入 OVATION 3，這表明他們相信 Imunon-001 對她們所照顧的女性的安全性和潛在益處。

They want to join with us in this crucial step towards bringing Imunon-001 forward as a novel and innovative therapeutic in ovarian cancer. Our highly experienced clinical development team is excited to have initiated the OVATION 3 trial and is eagerly planning the expansion of the trial over the next six months.

他們希望與我們一起邁出這一關鍵的一步，將 Imunon-001 推向卵巢癌的新型創新療法。我們經驗豐富的臨床開發團隊很高興啟動 OVATION 3 試驗，並熱切計劃在未來六個月內擴大試驗範圍。

I'll now turn the call back to Stacy.

我現在將電話轉回給 Stacy。

Thanks, Douglas. As we look towards financing our Phase 3 clinical trial, our goal is twofold: one is to ensure that we have done the best possible job for all stakeholders including our shareholders; and two, to raise capital in an amount that allows us to achieve our product development goals. And dilution is top-of-mind as we consider these options.

謝謝，道格拉斯。當我們尋求為我們的 3 期臨床試驗提供資金時，我們的目標有兩個：一是確保我們為包括股東在內的所有利益相關者提供盡可能最好的服務；二是籌集資金，以使我們能夠實現產品開發目標。當我們考慮這些選擇時，稀釋是首要考慮的問題。

Moreover and importantly, we have taken steps to conserve cash and align our critical needs with available capital on hand, while adding to the balance sheet through optimal opportunities. We're actively working on value-added financing and partnerships which will help secure a cash runway that supports our clinical timelines and long-term strategic objectives.

此外，更重要的是，我們已採取措施節約現金，並將我們的關鍵需求與現有資本結合，同時透過最佳機會增加資產負債表。我們正在積極致力於增值融資和合作夥伴關係，這將有助於確保支持我們的臨床時間表和長期策略目標的現金流。

Focusing on both technologies, TheraPlas and PlaCCine, we are having discussions with potential partners that have significant investment in oncology as well as vaccine development, some of these under CDA. We are also exploring geographic partnerships and ways to accelerate development of Imunon-001 in other parts of the world.

我們專注於 TheraPlas 和 PlaCCine 這兩種技術，正在與在腫瘤學和疫苗開發方面有大量投資的潛在合作夥伴進行討論，其中一些合作夥伴已簽署 CDA 協議。我們也正在探索地理合作夥伴關係以及加速在世界其他地區開發 Imunon-001 的方法。

And finally, we intend to leverage the data from the proof-of-concept trial, using our novel PlaCCine vaccine technology to sell or license that technology. Our PlaCCine technology offers several advantages and strong advantages over other vaccine platforms such as exceptional stability being viable for one year at 4-degree centigrade refrigerated temperatures and one month at 37 degree Celsius. The platform also has the ability for rapid adaptation to new pathogens or variants, longer lasting protection or durability, meaning it could be less frequent booster shots and cost-effective manufacturing.

最後，我們打算利用概念驗證試驗的數據，使用我們新穎的 PlaCCine 疫苗技術來銷售或授權該技術。與其他疫苗平台相比，我們的 PlaCCine 技術具有多項優勢和強大優勢，例如在 4 攝氏度冷藏溫度下可存活一年，在 37 攝氏度下可存活一個月的出色穩定性。該平台還具有快速適應新病原體或變種、更持久的保護或耐久性的能力，這意味著可以減少加強注射的頻率並實現具有成本效益的製造。

We shared insights from the PlaCCine proof-of-concept trial and the preclinical trials in this month, this last month April 2025 at both the AACR Annual Meeting and at the World Vaccine Congress and are following up with companies in the vaccine space. We are actively working on value-added financing and partnerships, which will help secure a cash runway. We will provide updates when we're able, and our goal is to cover OVATION 3 trial cost through corporate partnerships and equity.

我們在本月和上個月（2025 年 4 月）的 AACR 年會和世界疫苗大會上分享了 PlaCCine 概念驗證試驗和臨床前試驗的見解，並正在與疫苗領域的公司進行跟進。我們正在積極開展增值融資和合作夥伴關係，這將有助於確保現金流。我們將在有能力時提供更新，我們的目標是透過企業合作和股權來支付 OVATION 3 試用費用。

I'd now like to turn the call over to Dave Gaiero to review our financial results for the first quarter. Dave?

現在我想將電話轉給 Dave Gaiero 來回顧我們第一季的財務表現。戴夫？

Thank you, Stacy. Details of Imunon's first quarter 2025 financial results are included in the press release we issued this morning and in our Form 10-Q, which we filed before the market opened this morning.

謝謝你，史黛西。Imunon 2025 年第一季財務業績的詳細資訊包含在我們今天上午發布的新聞稿和我們今天上午開市前提交的 10-Q 表中。

As of March 31, 2025, Imunon had $2.9 million in cash and cash equivalents. We remain focused on securing near-term financing to strengthen the company's financial condition and advance OVATION 3.

截至 2025 年 3 月 31 日，Imunon 擁有 290 萬美元的現金和現金等價物。我們仍然專注於確保近期融資，以增強公司的財務狀況並推進 OVATION 3。

Research & development costs were $2.2 million for the first quarter of 2025, compared with $3.3 million for the same period in 2024. The decrease was due primarily to lower costs associated with the Phase 1 proof-of-concept PlaCCine DNA vaccine trial and the development of PlaCCine DNA vaccine technology platform.

2025 年第一季的研發成本為 220 萬美元，而 2024 年同期為 330 萬美元。下降的主要原因是與第一階段概念驗證 PlaCCine DNA 疫苗試驗以及 PlaCCine DNA 疫苗技術平台開發相關的成本降低。

General & administrative expenses were $2 million for the first quarter of 2025 compared to $1.7 million for the same period in 2024. The increase was primarily due to higher employee-related expenses.

2025 年第一季的一般及行政費用為 200 萬美元，而 2024 年同期為 170 萬美元。成長的主要原因是員工相關費用增加。

Net loss for the first quarter of 2025 was $4.1 million or $0.28 per share compared to a net loss of $4.9 million or $0.52 per share for the same period in 2024.

2025 年第一季淨虧損為 410 萬美元，即每股 0.28 美元，而 2024 年同期淨虧損為 490 萬美元，即每股 0.52 美元。

With that financial review, I turned the call back to Stacy.

經過財務審查後，我把電話轉回給了史泰西。

Thank you, Dave. With that, I'd like to open the call to your questions. Operator?

謝謝你，戴夫。現在，我想開始回答你們的問題。操作員？

(Operator Instructions) Emily Bodnar, HC Wainwright.

（操作員指示）Emily Bodnar，HC Wainwright。

Hello, Emily.

你好，艾米麗。

Hi. Thanks for taking the questions. Hello, and congrats on the progress. I guess first one I'll ask about the ASCO presentation, so congrats, obviously on getting an oral presentation. Is there anything new in terms of like sub-group analysis or any new data analysis that we should be expecting at the ASCO presentation? And will you potentially have the median OS for the HRD positive patients by then?

你好。感謝您回答這些問題。你好，祝賀你取得進展。我想首先要問的是有關 ASCO 演示的問題，所以恭喜你，顯然獲得了口頭演示。在 ASCO 演示中我們是否應該期待亞組分析或任何新數據分析的新內容？到那時，您是否有可能獲得 HRD 陽性患者的中位 OS？

So we are by nature of ASCO's embargo, Emily, I know you'll understand that not able to talk about the content of the presentation. They're very careful with what is shared in advance. We will be sharing new information and that I think is really quite central to being accepted as an oral presentation. Although I think the full body of evidence that we've been discussing merits a view at this level and at a platform like ASCO. So we're incredibly excited for the presentation and look forward to hearing Dr. Thaker's perspective on the data.

因此，艾米麗，我知道你會理解，由於 ASCO 的禁令，我們不能談論演示的內容。他們對提前分享的內容非常謹慎。我們將分享新的訊息，我認為這對於被接受為口頭陳述至關重要。儘管我認為我們一直在討論的全部證據都值得在這個層面上以及在 ASCO 這樣的平台上進行審視。因此，我們對這次演講感到非常興奮，並期待聽到 Thaker 博士對數據的看法。

Okay. Makes sense. And then, maybe just follow-up on the Phase 3 design. How many sites are you expecting to have in total for the trial for that, I guess, first half portion that you were discussing? And then are you having OS as a dual primary endpoint for HRD positive and the ITT population or how are you kind of splitting up the statistical plan? Thanks.

好的。有道理。然後，也許只是跟進第三階段的設計。對於您所討論的前半部分，您預計總共有多少個站點可以參與試驗？那麼，您是否將 OS 作為 HRD 陽性和 ITT 人群的雙重主要終點，或者您如何劃分統計計劃？謝謝。

I'll have -- Doug, why don't you take a step in.

我會——道格，你為什麼不進來一步呢？

Sure. The analysis for the Phase 3 has always been predicated on analyzing the HRD population first. This is the population in which we think from OVATION 2 data including data that will be presented at ASCO in which we have the highest effect in terms of activity. And so the population that would be read out first whether we proceed it with the entire HRD and HRP or whether we focus on HRD alone, as Stacy mentioned, the readout does not change. There are two interim analyses and a final analysis if needed all based on HRD events.

當然。第三階段的分析始終以先分析人力資源開發人口為前提。這是我們根據 OVATION 2 數據（包括將在 ASCO 上展示的數據）考慮的人群，我們在其中的活動效果最高。因此，無論我們進行整個 HRD 和 HRP 還是只關注 HRD，首先讀出的人口數都是相同的，正如 Stacy 所提到的，讀數不會改變。如有需要，將進行兩次中期分析和一次最終分析，全部基於 HRD 事件。

You asked the question --

你問了這個問題--

A number of sites.

多個站點。

A number of sites. We are projecting about 45 sites at this point.

多個站點。目前我們預計有大約 45 個站點。

Yeah. Emily, just to recap, so the overall survival of the primary is not dual and it is consistent for all populations as the primary.

是的。艾米麗，簡單回顧一下，原發性的整體生存率不是雙重的，並且對於所有人群來說都是一致的，都是原發性。

Got it. Okay. Thank you.

知道了。好的。謝謝。

James Molloy, Alliance Global Partners.

聯盟全球合作夥伴的詹姆斯‧莫洛伊 (James Molloy)。

Hello. This is Laura Suriel on for Jim Malloy. Thank you for taking my questions and congrats on the progress. So for OVATION 3, what's the current status that you have on like the inventory and the manufacturing capabilities for this trial especially with the 250 to 500 patient enrollment plan that you have set up?

你好。我是 Laura Suriel，為 Jim Malloy 主持節目。感謝您回答我的問題並祝賀您的進展。那麼對於 OVATION 3，您目前的庫存和製造能力如何，特別是考慮到您制定的 250 到 500 名患者的入組計劃？

Yeah. Great question and I'll take the opportunity just to reiterate that for this trial, we have pulled the manufacturing of the core active pharmaceutical ingredients in-house. And we are prepared and are monitoring various enrollment plans and ensuring that we have and will have continue to have product available. So we have had product that has passed all of the release specifications and has been ready to sit for weeks now and are well prepared for the weeks and months ahead.

是的。這個問題問得很好，我想藉此機會重申一下，在這次試驗中，我們已經在內部完成了核心活性藥物成分的生產。我們已經做好準備並正在監控各種招生計劃，確保我們已經並將繼續提供產品。因此，我們的產品已經通過了所有發布規範，並且已經準備好投入使用數週，為未來幾週和幾個月做好了充分的準備。

Got it. Thank you. And then also the clinical trial that you have in collaboration with the Breakthrough Cancer Foundation, what's the current status of this trial here? And are you still on track to have preliminary results announced later on this year?

知道了。謝謝。還有您與突破癌症基金會合作的臨床試驗，該試驗的當前狀態如何？您是否仍有望在今年稍後公佈初步結果？

You just had a call with the PIs, can you just give some insight from that?

您剛剛與 PI 進行了通話，能否提供一些見解？

We have a meeting with the principal investigators every two weeks. And the last one was a couple of days ago on Friday. We've initiated another site, University of Oklahoma and very excited about that. Johns Hopkins has managed to re-staff its clinical research group. And so they're excited about starting to screen patients. We are expecting to have data at the end of this year, yes.

我們每兩週與首席研究員舉行一次會議。最後一次是在幾天前的星期五。我們已經啟動了另一個網站，俄克拉荷馬大學，對此感到非常興奮。約翰霍普金斯大學已成功重新安排了臨床研究小組的人員。因此他們很高興開始對患者進行篩檢。是的，我們預計今年底就能取得數據。

All right. Thank you for the answers. Thanks for taking the questions.

好的。謝謝你的回答。感謝您回答這些問題。

Thank you.

謝謝。

This concludes our question-and-answer session of the call. I now want to turn the call back over to Imunon's President and CEO for including remarks, Dr. Lindborg.

我們的電話問答環節到此結束。現在我想將電話轉回給 Imunon 總裁兼執行長林德伯格博士，請他發表評論。

Thank you. I want to reiterate our near-term focus, which is on securing funds to strengthen the company's financial condition and advancing our Phase 3 trial and in the process, advancing Imunon-001. We expect to have an update on this front by the end of this quarter. And as referenced earlier, our goal is to cover the OVATION 3 trial cost, and we want to and will be seeking corporate partnering and equity financing. We expect this will be an iterative process driven by catalysts to further investor confidence and follow-on financings.

謝謝。我想重申我們近期的重點，即確保資金以增強公司的財務狀況並推進我們的第三階段試驗，並在此過程中推進 Imunon-001。我們預計將在本季末對此方面做出更新。如同前面所提到的，我們的目標是承擔 OVATION 3 的試用費用，我們希望並將尋求企業合作和股權融資。我們預計這將是一個由催化劑驅動的迭代過程，以進一步增強投資者信心和後續融資。

And as our work in providing a new treatment option for women with ovarian cancer progresses and as the population's exposure to potential pandemics increases, we remain very excited about reporting data from ongoing clinical studies in the months ahead. We look forward to keeping you appraised of our progress and thanks again for joining us today and for your interest in Imunon.

隨著我們為卵巢癌女性提供新的治療選擇的工作不斷進展，以及人口接觸潛在流行病的可能性增加，我們仍然非常高興在未來幾個月報告正在進行的臨床研究的數據。我們期待向您通報我們的進展，並再次感謝您今天加入我們並對 Imunon 的關注。

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

會議現已結束。感謝您參加今天的演講。您現在可以斷開連線。