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Operator
Operator
Good morning. My name is Darwin, and I will be your operator today. At this time, I would like to welcome you to IMUNON's second-quarter 2025 financial results conference call. (Operator Instructions)
早安.我叫達爾文,今天我將擔任您的接線生。現在,我歡迎您參加 IMUNON 2025 年第二季財務業績電話會議。(操作員指示)
I would now like to turn the call over to Peter Vozzo of ICR Healthcare, Investor Relations representative for IMUNON. Please go ahead.
現在,我想將電話轉給 ICR Healthcare 的 Peter Vozzo,他是 IMUNON 的投資者關係代表。請繼續。
Peter Vozzo - Investor Relations
Peter Vozzo - Investor Relations
Thank you, Darwin. Good morning, everyone, and welcome to IMUNON's second-quarter 2025 financial results and business update conference call.
謝謝你,達爾文。大家早安,歡迎參加 IMUNON 2025 年第二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, believes or other similar expressions.
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、相信或其他類似表達來識別。
These statements are based on current expectations and 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 those such statements. I also caution that the content of this conference call is accurate only as of the date of the live broadcast, August 5, 2025. IMUNON undertakes no obligation to revise or update comments made during this call, except as required by law.
這些聲明是基於當前預期,並受到許多風險和不確定因素的影響,包括公司向美國證券交易委員會定期提交的文件中所述的風險和不確定因素。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。我也提醒您,本次電話會議的內容僅在直播日期即 2025 年 8 月 5 日之前準確。除非法律要求,IMUNON 不承擔修改或更新本次電話會議期間所發表的評論的義務。
With that said, I would like to turn the call over to Dr. Stacy Lindborg, IMUNON's President and Chief Executive Officer. Stacy?
話雖如此,我想將電話轉給 IMUNON 總裁兼執行長 Stacy Lindborg 博士。史黛西?
Stacy Lindborg - President, Chief Executive Officer, Director
Stacy Lindborg - President, Chief Executive Officer, Director
Thank you, Peter, and good morning, everyone. Joining me on the call this morning is Dr. Douglas Faller, IMUNON's Chief Medical Officer; and Ms. Kimberly Graper, our Interim Chief Financial Officer, who will review our financial results for the second-quarter 2025; Mr. Michael Tardugno, the Executive Chairman of our Board; and Dr. Khursheed Anwer, our Chief Scientific Officer, are on the line and will be available for Q&A.
謝謝你,彼得,大家早安。今天早上與我一起參加電話會議的還有 IMUNON 的首席醫療官 Douglas Faller 博士;我們的臨時首席財務官 Kimberly Graper 女士,他們將審查我們 2025 年第二季度的財務業績;我們董事會的執行主席 Michael Tardugno 先生;以及我們的首席科學官 Khursheed Anwer 博士,他們在線上,將接受問答。
I want to begin by reviewing our progress in harnessing the potential of IMNN-001, our gene-mediated IL-12 therapy as an effective treatment for ovarian cancer, one of the most challenging forms of malignancies today. Our efforts reflect a deep commitment to unmet needs in oncology and to creating lasting value for patients and our stakeholders. The personal stories that I hear on an ongoing basis about the impact of ovarian cancer reinforce the urgency of our mission. It affects women across all ages and stages of life with profound devastation.
首先,我想回顧我們在利用 IMNN-001 的潛力方面取得的進展,IMNN-001 是我們的基因介導的 IL-12 療法,可有效治療卵巢癌,而卵巢癌是當今最具挑戰性的惡性腫瘤之一。我們的努力體現了對腫瘤學未滿足需求的堅定承諾,以及為患者和利害關係人創造持久價值的堅定承諾。我不斷聽到的有關卵巢癌影響的個人故事更加強調了我們使命的緊迫性。它給各個年齡層、各個人生階段的女性帶來深遠的破壞。
Recall that the frontline ovarian cancer treatment landscape has not seen an improvement in the standard of care platinum-based chemotherapy in over 25 years. Furthermore, prior to the OVATION 2 study, there has never been an overall survival benefit observed in a frontline ovarian cancer clinical trial. In addition, and importantly, clinical data from OVATION 2 across all endpoints and key subgroups have shown a consistent outcome favoring IMNN-001. And while not powered for statistical significance, our trial has shown unprecedented improvement in overall survival.
回想一下,25 年來,第一線卵巢癌治療領域的鉑類化療標準並未改善。此外,在 OVATION 2 研究之前,從未在卵巢癌一線臨床試驗中觀察到整體存活獲益。此外,重要的是,OVATION 2 所有終點和關鍵亞組的臨床數據均顯示出有利於 IMNN-001 的一致結果。雖然沒有統計意義,但我們的試驗顯示整體存活率得到了前所未有的改善。
Patients in the intent-to-treat population who were administered IMNN-001 plus the standard of care, neoadjuvant and adjuvant chemotherapy achieved a median increase in overall survival of 13 months compared to the standard of care alone. This is 46 months versus 33 months with a hazard ratio of 0.69, a 45% improvement. Use of PARP inhibitors as part of maintenance therapy further enhanced outcomes with median overall survival not yet reached in the IMNN-001 treatment arm after more than five years for many patients versus 37 months median overall survival in the control arm with a hazard ratio of 0.38.
在意圖治療族群中,接受 IMNN-001 合併標準治療、新輔助和輔助化療的患者與單獨接受標準治療的患者相比,整體存活期中位數增加了 13 個月。這是 46 個月對 33 個月,風險比為 0.69,改善了 45%。使用 PARP 抑制劑作為維持治療的一部分進一步改善了治療效果,IMNN-001 治療組的許多患者在超過五年後仍未達到中位總存活期,而對照組的中位總存活期為 37 個月,風險比為 0.38。
We are advancing rapidly and have a great potential to redefine treatment for women with advanced ovarian cancer. I'm delighted to share that our Phase 3 pivotal study of IMNN-001, which we refer to as OVATION 3, has had an impressive start. This builds directly on the strong data from our OVATION 2 study, which was showcased in an oral platform presentation at the recent ASCO Annual Meeting and was simultaneously published in the peer-reviewed journal, Gynecologic Oncology.
我們正在快速進步,並具有重新定義晚期卵巢癌女性治療方法的巨大潛力。我很高興地告訴大家,我們對 IMNN-001 的第三階段關鍵研究(我們稱之為 OVATION 3)取得了令人印象深刻的開端。這直接建立在我們 OVATION 2 研究的強大數據之上,該研究在最近的 ASCO 年會上的口頭平台報告中進行了展示,並同時發表在同行評審期刊《婦科腫瘤學》上。
Should results from the Phase 3 trial replicate these Phase 2 results, IMNN-001 could offer a transformative immune system engaging therapy that extends life meaningfully for patients. OVATION 3, our pivotal Phase 3 trial is gaining traction in the medical community as a vital advancement for frontline treatment in a population with few options.
如果 3 期試驗的結果能夠複製 2 期試驗的結果,IMNN-001 可以提供一種變革性的免疫系統參與療法,從而顯著延長患者的生命。OVATION 3 是我們的關鍵性 3 期試驗,它作為針對選擇較少的人群的一線治療的重要進步,正在醫學界獲得越來越大的關注。
The ASCO presentation and Gynecologic Oncology publication validate the robust evidence supporting IMNN-001 potential as evidenced by a couple of things: number one, direct comments to the milestone that OVATION 2 has delivered for ovarian cancer made in the Q&A portion of the live ASCO session. Number two, inclusion of IMNN-001's results in ASCO's highlights by medical journalists. And finally, interest expressed by principal investigators around the world to participate in our Phase 3 trial.
ASCO 的演講和《婦科腫瘤學》出版物驗證了支持 IMNN-001 潛力的強有力證據,這可以通過以下幾點來證明:第一,在 ASCO 現場會議的問答部分直接評論了 OVATION 2 為卵巢癌帶來的里程碑。第二,醫學記者將 IMNN-001 的結果納入 ASCO 的亮點中。最後,世界各地的首席研究員都表示有興趣參與我們的第三階段試驗。
We are poised to contribute significantly to oncology's future, and I hope this excitement is shared. I'll now provide an update on recent progress with IMNN-001's clinical and regulatory status. Our collaboration with clinical investigators remain strong and clearly is visible by the high interest and commitment to enrollment. A standout achievement is the speed of our Phase 3 launch.
我們準備為腫瘤學的未來做出重大貢獻,我希望大家能夠分享這種興奮之情。我現在將提供有關 IMNN-001 臨床和監管狀態的最新進展。我們與臨床研究人員的合作依然強勁,這一點從他們對招募的高度興趣和承諾中就可以看出。一個突出的成就是我們第三階段的啟動速度很快。
Industry benchmarks show an average of 28 weeks from protocol approval to enrollment opening, but we accomplished this in 15 weeks for OVATION 3, almost half of the time. This reflects our team's agility and both patient and investigators' enthusiasm. I want to congratulate Douglas and his team for this great start to the trial.
行業基準顯示,從協議批准到開始招生平均需要 28 週,但對於 OVATION 3,我們僅用了 15 週就完成了這一目標,幾乎節省了一半的時間。這體現了我們團隊的敏捷性以及患者和研究人員的熱情。我要祝賀道格拉斯和他的團隊,讓試驗取得了良好的開端。
To date, three sites have been activated, and we have randomized and treated our first patient last week. OVATION 3 evaluates IMNN-001 combined with the standard of care in neoadjuvant and adjuvant paclitaxel and carboplatin chemotherapy, which is administered before and after interval debulking surgery. And this is compared to the standard of care alone in newly diagnosed treatment-naive women 18 years of age or higher with advanced ovarian cancer. Participants are randomized 1:1, including a subgroup with homologous recombination deficiency or HRD-positive status, including BRCA1 and BRCA2 mutations (technical difficulty) in these women received PARP inhibitors and maintenance therapy.
到目前為止,已經有三個站點啟動,我們已在上週隨機分組並治療了第一位患者。OVATION 3 評估了 IMNN-001 與新輔助和輔助紫杉醇和卡鉑化療的標準治療相結合的效果,該方案在間隔減瘤手術之前和之後進行。這與 18 歲或以上新診斷的晚期卵巢癌未接受過治療的女性僅接受標準治療進行了比較。參與者以 1:1 隨機分配,包括一個同源重組缺陷或 HRD 陽性狀態的亞組,包括 BRCA1 和 BRCA2 突變(技術難度)這些女性接受了 PARP 抑制劑和維持治療。
The primary endpoint is overall survival with secondary endpoints, including surgical response score, chemotherapy response score, clinical response and time to second-line treatment. Exploratory endpoints such as quality-of-life measures will inform future pricing and payer discussions globally. We believe overall survival as the primary endpoint provides a clear path to approval without needing a follow-up study.
主要終點是整體存活期,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。生活品質測量等探索性終點將為全球未來的定價和付款人討論提供資訊。我們相信,以整體存活率作為主要終點提供了一條明確的批准途徑,而無需進行後續研究。
In addition, it supports potential European registration alongside our orphan designations in both Europe and US. The initial group of sites that will be activated this year, many from the prior OVATION 1 and OVATION 2 studies are highly motivated by the data we have produced to date. We plan to expand enrollment with new sites, which we anticipate will boost recruitment, positioning IMNN-001 as a potential new standard if Phase 3 confirms OVATION 2 safety and efficacy.
此外,它還支持潛在的歐洲註冊以及我們在歐洲和美國的孤兒藥指定。今年將啟動的首批站點,其中許多來自先前的 OVATION 1 和 OVATION 2 研究,它們都受到我們迄今為止所產生的數據的極大激勵。我們計劃透過新站點擴大招募範圍,預計這將促進招募,如果第 3 階段確認 OVATION 2 的安全性和有效性,IMNN-001 將成為一個潛在的新標準。
Our flexible strategy supports a 500-patient all-comers trial or a 250-patient HRD-positive subgroup, both with 95% power or higher on the primary endpoint for an FDA approval. We're starting the trial with a 250-patient HRD-positive subgroup identified through central laboratory biomarker testing, which will reduce the cost by 40% and enable early stopping for efficacy for successful milestones. This population addresses half of the neoadjuvant population, and we may expand to the 500-patient all-comers population later budget permitting.
我們的靈活策略支持 500 名患者的全受試者試驗或 250 名患者的 HRD 陽性亞組試驗,兩者在 FDA 批准的主要終點上均具有 95% 或更高的功效。我們將透過中央實驗室生物標記測試確定 250 名 HRD 陽性患者亞組,以此開始試驗,這將降低 40% 的成本,並能夠在達到成功里程碑時儘早停止療效。這個群體涵蓋了新輔助治療群體的一半,如果預算允許,我們以後可能會將其擴大到 500 名患者的全能治療群體。
To keep OVATION 2's momentum alive and mid-Phase 3, the ASCO oral presentation delivered by Dr. Premal H. Thaker and the simultaneous publication in Gynecologic Oncology, two preeminent platforms, highlight the need for new therapies and the promise of our TheraPlas platform. Preparing for these disclosures, we dove further into the OVATION 2 data, we discovered that in addition to unprecedented survival data and consistency of data with all clinical endpoints and key subgroups favoring IMNN-001, we learned that all patients in the experimental arm, those treated with IMNN-001, remained progression-free during the treatment protocol, while progressions were observed in the control arm.
為了保持 OVATION 2 的勢頭並進入第 3 階段中期,Premal H. Thaker 博士在 ASCO 上發表的口頭報告以及同時在《婦科腫瘤學》(兩個傑出的平台)上發表的文章強調了對新療法的需求以及我們的 TheraPlas 平台的前景。為了準備這些揭露,我們進一步研究了 OVATION 2 數據,我們發現除了前所未有的生存數據和與所有臨床終點和關鍵亞組的數據一致性有利於 IMNN-001 之外,我們還了解到實驗組(用 IMNN-001 治療)的所有患者在治療方案期間保持無進展,而在對照組中觀察到對照組進展。
I'll now hand the call over to Dr. Douglas Faller, IMUNON's Chief Medical Officer, to comment further on the excitement from the medical community from ASCO and to share insights on OVATION 3, including with the discussions that you're having with investigators during site activation and enrollment. Douglas?
現在,我將把電話交給 IMUNON 的首席醫療官 Douglas Faller 博士,請他進一步評論 ASCO 醫學界的興奮之情,並分享對 OVATION 3 的見解,包括您在站點激活和招募期間與研究人員進行的討論。道格拉斯?
Douglas Faller - Chief Medical Officer
Douglas Faller - Chief Medical Officer
Thank you, Stacy. This is really an exhilarating period for IMUNON. Beyond our ASCO podium presentation and the journal publication of OVATION 2 results, we were invited to share new OVATION 2 data at the International ESMO Gynaecological Cancers Meeting in June. And we'll also be delivering trial in progress presentations at both the full ESMO Annual Congress in October 2025 and at the International Gynecologic Society International Congress in November 2025.
謝謝你,史黛西。對IMUNON來說,這真是一段令人振奮的時期。除了在 ASCO 大會上進行演示和在期刊上發表 OVATION 2 研究結果之外,我們還受邀在 6 月份的國際 ESMO 婦科癌症會議上分享新的 OVATION 2 數據。我們也將在 2025 年 10 月舉行的 ESMO 年度大會和 2025 年 11 月舉行的國際婦科學會國際大會上進行試驗進度報告。
Additionally, in the last few days, we've also had invitations to present the newer translational data from OVATION 2 at two major scientific conferences this fall. Starting with the ESMO conference, I had the honor to present data which confirms that IMNN-001 delivers targeted IL-12 gene therapy to tumors with minimal systemic exposure.
此外,在過去的幾天裡,我們還收到邀請,將在今年秋季的兩次大型科學會議上展示來自 OVATION 2 的最新轉換數據。從 ESMO 會議開始,我很榮幸能夠展示數據,證實 IMNN-001 能夠以最小的全身暴露為腫瘤提供靶向 IL-12 基因治療。
This underpins both the safety and the efficacy that we've seen in the OVATION 2 trial. New insights we presented at that meeting demonstrated marked infiltration of immune cells, including antitumor lymphocytes and reprogrammed macrophages into the peroneal areas that previously contained ovarian tumor after the patients have been treated with IMNN-001. In many cases, no remaining tumor tissue could be observed pathologically.
這鞏固了我們在 OVATION 2 試驗中看到的安全性和有效性。我們在該會議上提出的新見解表明,在患者接受 IMNN-001 治療後,免疫細胞(包括抗腫瘤淋巴細胞和重編程巨噬細胞)明顯浸潤到先前含有卵巢腫瘤的腓骨區域。在許多情況下,病理學上無法觀察到殘留的腫瘤組織。
Turning to the OVATION 3 trial, as Stacy mentioned, we've activated three clinical sites with additional site activations on deck, including one tomorrow morning. Many of the top institutions and investigators from OVATION 2 are rejoining OVATION 3, driven by their confidence in IMNN-001's benefits. They are eager to advance our innovative therapy. As a result of our presentations at ASCO and ESMO Gynaecological Conference, we're actually getting calls from investigators around the country and internationally asking if they could participate in our study.
談到 OVATION 3 試驗,正如 Stacy 所提到的,我們已經啟動了三個臨床站點,並且正在準備啟動其他站點,包括明天早上的一個。許多來自 OVATION 2 的頂尖機構和研究人員由於對 IMNN-001 的益處充滿信心而重新加入 OVATION 3。他們渴望推進我們的創新療法。由於我們在 ASCO 和 ESMO 婦科會議上進行了演示,我們實際上接到了來自全國和國際研究人員的電話,詢問他們是否可以參與我們的研究。
This is certainly unusual in my experience and very encouraging. The ability to employ a tumor-targeted immune therapy in the neoadjuvant setting holds great appeal among gynecologic oncologists and medical oncologists. I'm also very pleased to report, as Stacy mentioned, that we enrolled our first patient in OVATION 3 on July 25, 2025. Our seasoned clinical team is thrilled with the progress, and we're planning further trial expansion in the coming months.
這在我的經驗中確實是不尋常的,而且非常令人鼓舞。在新輔助治療中採用腫瘤標靶免疫療法的能力對婦科腫瘤學家和腫瘤內科醫生具有很大的吸引力。正如 Stacy 所提到的,我很高興地報告,我們於 2025 年 7 月 25 日在 OVATION 3 中招募了第一位患者。我們經驗豐富的臨床團隊對這項進展感到非常興奮,我們計劃在未來幾個月進一步擴大試驗。
Back to you, Stacy.
回到你身邊,史黛西。
Stacy Lindborg - President, Chief Executive Officer, Director
Stacy Lindborg - President, Chief Executive Officer, Director
Thanks, Douglas. Actually, before I proceed with a few comments around our plans to finance OVATION 3, Khursheed, I wonder if you'd like to make any additional perspective, provide your thoughts on our translational data. Khursheed?
謝謝,道格拉斯。實際上,在我對資助 OVATION 3 的計劃發表一些評論之前,Khursheed,我想知道您是否願意提出任何其他觀點,並對我們的轉化數據提供您的想法。庫爾希德?
Khursheed Anwer - Executive Vice President, Chief Scientific Officer
Khursheed Anwer - Executive Vice President, Chief Scientific Officer
Sure, Stacy. Yes, the outstanding survival benefits we have seen in OVATION 2 indeed are supported by the recent translational work. First, the local increases in cytokines in peritoneal space and not as much in blood following IMNN-001 administration supports the drug objectives in achieving local effects without producing systemic toxicity.
當然,史黛西。是的,我們在 OVATION 2 中看到的出色的生存優勢確實得到了最近的轉化研究的支持。首先,注射 IMNN-001 後,腹膜空間中的細胞因子局部增加,而血液中的細胞因子則沒有那麼多,這支持了藥物目標,即實現局部效果而不產生全身毒性。
Second, the immunological changes in the tumor microenvironment that Douglas has described provide mechanistic insight into how the increase in local cytokine levels by IMNN-001 translates into antitumor activity at tumor microenvironment, which is not only driving the IMNN-001 action, but could also promote actions of other immune agents such as checkpoint inhibitors. We are truly excited to see continued development of IMNN-001.
其次,道格拉斯所描述的腫瘤微環境中的免疫學變化提供了機制上的見解,說明 IMNN-001 增加的局部細胞因子水平如何轉化為腫瘤微環境中的抗腫瘤活性,這不僅推動了 IMNN-001 的作用,而且還可以促進其他免疫劑(如檢查點抑製劑)的作用。我們非常高興看到 IMNN-001 的持續發展。
Thank you, Stacy.
謝謝你,史黛西。
Stacy Lindborg - President, Chief Executive Officer, Director
Stacy Lindborg - President, Chief Executive Officer, Director
Khursheed, I know we'll have a lot more to say about our translational data, which we're quite excited about in addition to our clinical, and we can certainly take more questions as they come. And for those of you that have been following IMUNON over time, you'll know that Khursheed, our Chief Scientific Officer, has been central to many parts of our business, including the translational strategy. So I appreciate those insights.
庫爾希德,我知道我們還有很多關於轉化數據要說,除了臨床數據之外,我們對此感到非常興奮,我們當然可以回答更多問題。對於那些長期關注 IMUNON 的人來說,你們會知道,我們的首席科學官 Khursheed 在我們業務的許多部分都發揮著核心作用,包括轉化策略。所以我很欣賞這些見解。
Turning to financing, the OVATION 3 study. I want to reflect on the fact that we have been caught in a challenging capital markets environment, along with many other companies. Our strategy to emerge out of this turmoil in a stronger position is being followed almost exactly as we planned. Our priorities are to optimize outcomes for all stakeholders, including shareholders, while raising sufficient capital for our development goals.
談到融資,OVATION 3 研究。我想反思一下,我們和許多其他公司一樣,陷入了充滿挑戰的資本市場環境。我們擺脫這場動盪、變得更強大的策略幾乎完全按照我們的計劃進行。我們的首要任務是為包括股東在內的所有利害關係人優化成果,同時為我們的發展目標籌集足夠的資金。
We recognize that dilution is a top concern for our shareholders, particularly as a biotech company that must raise capital to advance our promising Phase 3 program. We are fully committed to minimizing shareholder dilution wherever possible while acknowledging that not every financing option will be ideal. To this end, we're actively pursuing nondilutive strategies and working to attract long-term institutional investors who align with our vision and can support sustainable growth for all stakeholders.
我們認識到,稀釋是我們股東最關心的問題,特別是作為一家必須籌集資金來推進我們有前景的第三階段計劃的生物技術公司。我們全力致力於盡可能減少股東股權稀釋,同時也承認並非每種融資方案都是理想的。為此,我們積極推行非稀釋性策略,並努力吸引符合我們願景並能支持所有利害關係人可持續成長的長期機構投資者。
I'll provide an update on these fronts, but first, I'm excited to announce that we have introduced a onetime stock dividend designed to enhance shareholder value and to underscore our strong confidence in IMUNON's long-term growth potential. This initiative will benefit shareholders of record as of August 7, two days from now, by distributing a 15% dividend in common stock, effectively increasing their ownership stake without any cash outlays from the company.
我將提供有關這些方面的最新情況,但首先,我很高興地宣布,我們推出了一次性股票股利,旨在提高股東價值並強調我們對 IMUNON 長期成長潛力的堅定信心。這項舉措將使兩天後(8 月 7 日)登記在冊的股東受益,透過派發 15% 的普通股股息,有效地增加他們的所有權股份,而無需公司進行任何現金支出。
As a late-stage pre-revenue biotech firm dedicated to advancing transformative therapies like IMNN-001, this forward-thinking strategy aligns with our commitment to minimizing unnecessary dilution while promoting a greater liquidity and accessibility to our stock. By thoughtfully increasing the number of shares outstanding, we aim to broaden our investor base spark heightened demand and drive sustainable value creation for all stakeholders as we advance through our Phase 3 milestones and beyond.
作為一家致力於推進 IMNN-001 等變革性療法的後期盈利前生物技術公司,這項前瞻性策略符合我們致力於最大限度地減少不必要的稀釋,同時提高股票流動性和可及性的承諾。透過深思熟慮地增加流通股數量,我們的目標是擴大投資者基礎,激發更高的需求,並在我們邁向第三階段里程碑及以後的過程中為所有利益相關者創造可持續的價值。
Since June 30, 2025, we bolstered our balance sheet by adding more than $3 million through the exercise of warrants and sale of shares off of our ATM facility. Carefully balancing stakeholder needs and minimizing dilution, we continue to prioritize partnerships and aim to expand our institutional investor base to extend our cash runway for clinical and strategic objectives. We've implemented cash conservation methods, including reducing monthly rent commitments, reducing G&A expenses, aligning resources with priorities by removing work not contributing to regulatory approval and commercial launch of IMNN-001 and pursuing value-enhancing opportunities.
自 2025 年 6 月 30 日起,我們透過行使認股權證和出售 ATM 設施的股票增加了 300 多萬美元,從而增強了我們的資產負債表。我們仔細平衡利害關係人的需求並儘量減少稀釋,繼續優先考慮合作夥伴關係,並致力於擴大我們的機構投資者基礎,以延長我們的臨床和戰略目標的現金跑道。我們實施了現金節約方法,包括減少每月租金承諾、減少一般及行政費用、透過取消對 IMNN-001 的監管批准和商業發布無貢獻的工作來使資源與優先事項保持一致,並尋求增值機會。
Our financing and partnership efforts include advancing the TheraPlas technology through discussions with potential partners who are oncology leaders, which include meetings held in person at ASCO, some under CDA, exploring geographic partnerships to speed IMNN-001 development globally, leveraging PlaCCine, our DNA vaccine platform's proof-of-concept data for potential sale or licensing, highlighting its advantages of stability, a year at refrigerated temperatures of 4 degrees centigrade or one month at room temperature or 37 degrees centigrade.
我們的融資和合作努力包括透過與腫瘤學領域的領導者等潛在合作夥伴進行討論來推進 TheraPlas 技術,這些討論包括透過與腫瘤學領域的領導者等潛在合作夥伴進行討論來推進 TheraPlas 技術,這些討論包括在 ASCO 舉行的面對面會議,一些是在 CDA 下舉行的會議,探索地理合作夥伴關係以加快全球 IMNN-001 的開發,利用 PlaCCine,我們的 DNA 穩定性平台的概念驗證數據攝氏的冷藏溫度下可保存一年,在室溫或攝氏 37 度下可保存一個月。
Rapid adaptability from a manufacturing standpoint, durable protection. We had six months durability, you'll recall discussed in our recent earnings call and cost-effective production. We presented PlaCCine insights at AACR, the American Association for Clinical Research Annual Meeting and the World Vaccine Congress in April 2025 and are engaging vaccine companies. We'll provide updates on these efforts as they progress.
從製造角度來看,適應性快,保護持久。我們有六個月的耐用性,你會記得在我們最近的收益電話會議和具有成本效益的生產中討論過。我們於 2025 年 4 月在 AACR、美國臨床研究協會年會和世界疫苗大會上介紹了 PlaCCine 的見解,並與疫苗公司進行了接觸。我們將隨著這些工作的進展提供最新消息。
The goal is to fund OVATION 3 through partnerships and equity. Partnerships take time to develop. And while I can't share more at this time, we are seeing interest.
目標是透過合作和股權為 OVATION 3 提供資金。夥伴關係需要時間來建立。雖然我現在不能分享更多信息,但我們看到大家的興趣。
On our Nasdaq listing, we're pleased to confirm that we've received support from Nasdaq staff as we implement our compliance plan to return to full compliance. Following the Nasdaq hearing panel in early July of this year, we were granted additional time, time that was tailored to what we need to regain compliance. The panel noted that IMUNON has already achieved compliance with shareholder equity rule through recent fundraising activities, and we anticipate that we will meet the minimum bid price requirement as early as this Friday when the share price is expected to remain above $1 for 10 consecutive days.
在納斯達克上市方面,我們很高興地確認,在我們實施合規計畫以恢復完全合規的過程中,我們得到了納斯達克員工的支持。今年 7 月初納斯達克聽證會之後,我們獲得了額外的時間,這些時間是根據我們重新遵守規定所需的時間量身定制的。專家小組指出,IMUNON 透過最近的籌資活動已經實現了股東權益規則的遵守,我們預計最早將於本週五滿足最低出價要求,屆時股價預計將連續 10 天保持在 1 美元以上。
We'll provide an update to the hearing panel on the status of compliance with the bid price rule on August 8, and we'll update the hearing panel on the status of our strategy to maintain compliance on shareholder equity requirement in the second half of August. I am confident in our actions and that they will continue to provide a platform that will deliver long-term value for our shareholders.
我們將於 8 月 8 日向聽證小組更新遵守投標價格規則的情況,並將於 8 月下半月向聽證小組更新我們保持遵守股東權益要求的策略的情況。我對我們的行動充滿信心,並相信它們將繼續為我們的股東提供長期價值的平台。
Now I'll turn it over to Kim Graper. Kim, if you will review our second-quarter 2025 financial results.
現在我將把發言權交給 Kim Graper。Kim,請您回顧我們 2025 年第二季的財務表現。
Kimberly Graper - Interim Chief Financial Officer
Kimberly Graper - Interim Chief Financial Officer
Thank you, Stacy. Detail of IMUNON's second-quarter 2025 financial results are included in the press release, which 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 年第二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 June 30, 2025, cash and cash equivalents were $4.7 million. Following the end of the second quarter, the company received approximately $3 million of net proceeds from the exercise of warrants and sales under its ATM facility. The ATM facility carries a nominal 3% fee with no warrants. R&D expenses were $1.2 million for Q2 2025, down from $2.8 million in the same period last year. primarily due to completion of the OVATION 2 study and lower costs associated with the Phase 1 PlaCCine DNA vaccine trial and development costs for the PlaCCine DNA vaccine technology platform.
截至 2025 年 6 月 30 日,現金及現金等價物為 470 萬美元。第二季結束後,該公司透過行使認股權證和 ATM 設施下的銷售獲得了約 300 萬美元的淨收益。ATM 設施僅收取 3% 的象徵性費用,且無需任何保證。2025 年第二季的研發費用為 120 萬美元,低於去年同期的 280 萬美元。這主要是由於 OVATION 2 研究的完成以及與第一階段 PlaCCine DNA 疫苗試驗相關的成本以及 PlaCCine DNA 疫苗技術平台的開發成本降低。
G&A expenses were $1.5 million in Q2 2025, down from $2.2 million in the same period last year due to lower employee-related and legal expenses. Net loss for Q2 2025 was $2.7 million or $2.15 per share compared to $4.8 million or $7.64 per share in the second-quarter of 2024. Please note that all share amounts and per share amounts have been adjusted to reflect a 15-for-1 reverse stock split of our common stock, which we effected on July 25, 2025.
2025 年第二季的一般及行政費用為 150 萬美元,低於去年同期的 220 萬美元,原因是員工相關費用和法律費用減少。2025 年第二季淨虧損為 270 萬美元,即每股 2.15 美元,而 2024 年第二季淨虧損為 480 萬美元,即每股 7.64 美元。請注意,所有股份數量和每股金額均已調整,以反映我們於 2025 年 7 月 25 日實施的 15 比 1 的普通股反向股票分割。
With that financial review, I'll turn the call back to Stacy.
完成財務審查後,我會將電話轉回給 Stacy。
Stacy Lindborg - President, Chief Executive Officer, Director
Stacy Lindborg - President, Chief Executive Officer, Director
Thank you, Kim. And with that, I'd like to open the call to your questions. Darwin?
謝謝你,金。現在,我想開始回答你們的問題。達爾文?
Operator
Operator
(Operator Instructions) Emily Bodnar, H.C. Wainwright.
(操作員指示)Emily Bodnar,H.C. Wainwright。
Emily Bodnar - Equity Analyst
Emily Bodnar - Equity Analyst
Congrats on the progress with the Phase 3 trial. I know you talked a bit about the enthusiasm from the investigator side with the Phase 3 trial. I was curious if you could talk a bit about initial demand from the patient side, if these investigators have, say, a set of patients that they'd initially like to enroll on the trial?
恭喜第三階段試驗取得進展。我知道您談到了研究人員對第三階段試驗的熱情。我很好奇,您是否可以談談患者方面的初步需求,這些研究人員是否有一組他們最初想參加試驗的患者?
And I guess, how you're kind of thinking about pace of patient enrollment, specifically in the HRD subset of patients that you spoke about? And then I'll ask a follow-up after.
我想,您如何看待患者入組的速度,特別是您提到的 HRD 患者子集?然後我會問後續情況。
Stacy Lindborg - President, Chief Executive Officer, Director
Stacy Lindborg - President, Chief Executive Officer, Director
Douglas, do you want to take this?
道格拉斯,你想拿這個嗎?
Douglas Faller - Chief Medical Officer
Douglas Faller - Chief Medical Officer
I'd be happy to. The first part of your question was about whether investigators have patients for this study. And there are a couple of parts to the answer. One is, as I'm sure you know, because we've said it many times before, improvements in frontline treatment in ovarian cancer have really not changed for 25 years. We're treating patients the same way we treated patients when I was a medical student.
我很樂意。您的問題的第一部分是關於研究人員是否有患者參與這項研究。答案有幾個部分。一是,我相信您知道,因為我們之前已經說過很多次了,卵巢癌一線治療的改進 25 年來實際上沒有改變。我們對待病人的方式與我當醫學生時對待病人的方式相同。
This has helped people, but it has certainly not been enough. There have been many efforts to improve frontline treatment of patients with ovarian cancer. But the most recent ones, including using checkpoint inhibitors, all four of them, large Phase 3 studies failed in the last year. And there really is very little now for patients. So we believe that the demand and the opportunity for our Phase 3 study is high.
這對人們有幫助,但肯定還不夠。人們已經做出許多努力來改善卵巢癌患者的第一線治療。但最近的四項大型 3 期臨床試驗(包括使用檢查點抑制劑的試驗)都在去年失敗了。而現在,可供患者使用的資源確實非常少。因此,我們相信,我們的第三階段研究的需求和機會很高。
Let me also mention, though, since I said that the checkpoint inhibitors have not worked, that is an immunotherapy, but it is completely different than our approach. The checkpoint inhibitors depend on having a tumor that is immunologically hot and inflamed, ovarian cancer is not. We, on the other hand, are using a therapy, IL-12, which actually activates and causes, let's say, inflammation immune activity in the tumor cell and in the tumor microenvironment. So our approach gets around the problems that led to checkpoint inhibitors not being active.
不過,我還要提一下,既然我說過檢查點抑制劑沒有起作用,那是一種免疫療法,但它與我們的方法完全不同。檢查點抑制劑依賴免疫熱和發炎的腫瘤,而卵巢癌則不然。另一方面,我們正在使用一種名為 IL-12 的療法,它實際上可以激活並引起腫瘤細胞和腫瘤微環境中的發炎免疫活動。因此,我們的方法解決了導致檢查點抑制劑不活躍的問題。
The second part of your question involved our interest in the HRD population. Stacy mentioned that a focus on this is likely to give us the strongest signal and the strongest benefit in patients with ovarian cancer. About 50% of frontline patients with ovarian cancer are HRD mutant. And so, this represents half of the entire population of ovarian cancer patients frontline who are underserved currently.
您問題的第二部分涉及我們對人力資源發展人群的興趣。史泰西提到,關注這一點可能會為我們帶來最強烈的訊號,並為卵巢癌患者帶來最大的益處。約50%的卵巢癌第一線患者是HRD突變型。因此,這代表著目前未充分治療的第一線卵巢癌患者總數的一半。
Emily Bodnar - Equity Analyst
Emily Bodnar - Equity Analyst
Got it. Okay. Also, I guess, on the expenses side, it looks like your operating expenses declined pretty significantly this quarter. Can you just talk a bit about how you're expecting expenses to change for the remainder of the year as you're kind of bumping up enrollment in the Phase 3 trial?
知道了。好的。另外,我想,從費用方面來看,本季度您的營運費用似乎大幅下降了。您能否簡單談談,隨著第三階段試驗的報名人數不斷增加,您預計今年剩餘時間的費用將如何變化?
Stacy Lindborg - President, Chief Executive Officer, Director
Stacy Lindborg - President, Chief Executive Officer, Director
Yeah, Emily. As you point out, yes, our expenses have declined. That is in part due to the PlaCCine proof-of-concept trial that was concluded and that we're not starting any new work on that front. OVATION 2, as you know, is also winding down, and we're closing sites on a monthly basis as the sites reach the point of no longer having patients ongoing.
是的,艾米麗。正如您所指出的,是的,我們的開支確實下降了。部分原因是 PlaCCine 概念驗證試驗已經結束,我們不會在該方面進行任何新工作。如您所知,OVATION 2 也正在逐步關閉,當網站達到不再接收患者的程度時,我們將按月關閉網站。
But really, we've been very diligent to control cost and to make sure that we're allowing the time that we need to fund -- to fully fund our trial. And that's been -- that's proven to be very important. I think it's also very critical for our staff to understand that we're investing in places we need to invest, and we're minimizing other expenses.
但實際上,我們一直非常努力地控製成本,並確保我們有足夠的時間來資助我們的試驗。事實證明,這一點非常重要。我認為,讓我們的員工明白我們正在投資需要投資的地方,我們正在盡量減少其他開支,這也非常重要。
In terms of the OVATION 3 trial cost, as you know, in advance of starting the trial, we, of course, had to manufacture and produce active pharmaceutical ingredients, which we're doing in-house ahead of the final fill and finish well in advance of the first patient being enrolled. So the investment in start-up costs with OVATION 3 really proceeded well in advance of the first patient.
就 OVATION 3 試驗成本而言,如您所知,在開始試驗之前,我們當然必須製造和生產活性藥物成分,這些工作都是在內部完成的,以便在第一位患者入組之前完成最終填充和完成。因此,OVATION 3 的啟動成本投資實際上在第一位患者到來之前就已經進行了。
And as a result, really, we're manufacturing in a manner that is modeling and planning for enrollments. We'll be monitoring them in real time. And so, we'll really see fairly stable expenses that will continue consistent with, I think, what you're seeing in our filing from this Q.
因此,我們實際上是以一種為招生建模和規劃的方式進行製造的。我們將即時監控它們。因此,我們將看到相當穩定的支出,我認為這將與您在本季度提交的文件中看到的情況保持一致。
Operator
Operator
Will Hidell, Brookline Capital Markets.
布魯克林資本市場 (Brookline Capital Markets) 的威爾希德爾 (Will Hidell)。
Will Hidell - Analyst
Will Hidell - Analyst
I have two questions. One, the combination study with [Avastin], is that still on track for enrollment? I think the updated number is 15 patients as of June. Is that going as expected?
我有兩個問題。第一,與 [Avastin] 的聯合研究是否仍在按計劃進行招募?我認為截至 6 月更新後的數字是 15 名患者。一切如預期嗎?
Stacy Lindborg - President, Chief Executive Officer, Director
Stacy Lindborg - President, Chief Executive Officer, Director
So we have -- we are continuing to enroll patients. We have increased the number that has -- that have been treated and have some recent activities that have been long underway that are going to give added strength to this trial's speed of enrollment. So we have a site that was part of the OVATION 2 trial and is a PI that is quite familiar with IMNN-001 and enrolled extremely well that will be -- I'm being assured by lawyers on both sides that this contract really is ready to sign and is just going through the finishing touches.
因此,我們正在繼續招募患者。我們已經增加了接受治療的人數,最近進行的一些活動已經進行了很長時間,這些活動將進一步加快該試驗的招募速度。因此,我們有一個參與 OVATION 2 試驗的站點,並且是一個對 IMNN-001 非常熟悉的 PI,並且招募得非常好——雙方的律師都向我保證,這份合約確實已經準備好簽署,只是在進行最後的潤色。
And in discussions with our other PIs, MD Anderson is continuing to enroll incredibly well at rates that are far above the OVATION 2 numbers as a trial as a whole. And we have Memorial Sloan Kettering that has met their internal goals and will be continuing -- have set new goals before the end of the year.
在與我們其他 PI 的討論中,MD Anderson 的招募情況繼續保持著令人難以置信的良好勢頭,其招募率遠高於 OVATION 2 試驗的整體招募人數。紀念斯隆凱特琳癌症中心已經實現了其內部目標,並將繼續在年底前設定新的目標。
So we're -- frankly, we'd love to see this trial be increasing in speed. We have a corporate goal for this year, which we are, I would say, observing and working very closely with the sites to see if we're able to get it done. But we do have some changes as I've just gone through that leave us optimistic that we'll be able to get to the $35 million that we want to have by the end of the year, but we'll give updates over time.
所以,坦白說,我們希望看到這次試驗的速度加快。我們今年有一個企業目標,我想說的是,我們正在觀察並與各個站點密切合作,看看我們是否能夠實現這個目標。但正如我剛剛經歷的那樣,我們確實有一些變化,這讓我們樂觀地認為,我們將能夠在今年年底前達到我們想要的 3500 萬美元,但我們會隨著時間的推移提供更新資訊。
Will Hidell - Analyst
Will Hidell - Analyst
And then a quick clarification question. The $3 million raised during the quarter between the warrants and ATM, what was the mix between exercised warrants and the ATM?
然後是一個快速澄清的問題。本季認股權證和 ATM 之間籌集了 300 萬美元,行使的認股權證和 ATM 之間的比例是多少?
Stacy Lindborg - President, Chief Executive Officer, Director
Stacy Lindborg - President, Chief Executive Officer, Director
Yeah. Kim, would you like to take this?
是的。金,你想拿這個嗎?
Kimberly Graper - Interim Chief Financial Officer
Kimberly Graper - Interim Chief Financial Officer
Yeah. The mix between the ATM and the warrants was very close to 50-50 each with $1.5 million.
是的。自動櫃員機和認股權證的比例非常接近 50-50,均為 150 萬美元。
Operator
Operator
David Bautz, Zacks Small-Cap Research.
David Bautz,Zacks Small-Cap Research。
David Bautz - Analyst
David Bautz - Analyst
So I have a couple on the clinical trial site. What needs to be done for any remaining sites that want to be open? Basically, what I'm asking, is it just financing that's holding that up at this point?
所以我在臨床試驗現場有幾個。對於希望開放的剩餘場地,需要做些什麼?基本上,我想問的是,目前阻礙這一進程的只是融資問題嗎?
And you also indicated that positive results from the OVATION 3 study may set you up for filing in the EU. My question is, will the EU require to open any sites over there during the trial? Or does the company have any plans to open sites over there?
您也表示,OVATION 3 研究的積極結果可能為您在歐盟提交申請做好準備。我的問題是,歐盟是否會要求在試驗期間開放那裡的任何地點?或者該公司是否有在那裡開設站點的計劃?
Stacy Lindborg - President, Chief Executive Officer, Director
Stacy Lindborg - President, Chief Executive Officer, Director
Why don't you take the second question first, Douglas?
道格拉斯,你為什麼不先回答第二個問題呢?
Douglas Faller - Chief Medical Officer
Douglas Faller - Chief Medical Officer
Okay. It is -- it's not been absolutely necessary for the EU that there will be patients enrolled in a study for them to give approval. The issues -- most of the issues with approval in the EU have been with trials that don't have OS as an endpoint. And so demonstrating an OS benefit in a disease like this should not present any difficulties for approval in the EU.
好的。是的-歐盟不一定需要有病人參與研究才能給予批准。問題—歐盟批准的大多數問題都與沒有 OS 作為終點的試驗有關。因此,證明 OS 對此類疾病的益處應該不會給歐盟的批准帶來任何困難。
We are considering sites in Europe. We have collectively a great deal of experience in working with sites in Europe, I know many of the investigators. And so that is something we are considering as we expand and hopefully accelerate OVATION 3. But in my experience, it's not been necessary to enroll patients in the EU.
我們正在考慮在歐洲設立站點。我們在與歐洲站點合作方面擁有豐富的經驗,我認識許多調查員。因此,這是我們在擴展並希望加速 OVATION 3 時正在考慮的事情。但根據我的經驗,沒有必要在歐盟招募患者。
Stacy Lindborg - President, Chief Executive Officer, Director
Stacy Lindborg - President, Chief Executive Officer, Director
And the first question was related to what's required to open additional sites. And I guess I'll -- maybe I'll start, and Douglas, please add. I mean, I think it's very common that you have a plan of kind of a time line around activating sites. It is -- you want to move quickly, but it needs to be staged and I think ordered.
第一個問題與開設更多站點需要什麼有關。我想我會——也許我會開始,道格拉斯,請補充。我的意思是,我認為制定一個圍繞激活站點的時間表計劃是很常見的。是的——你想快速行動,但它需要分階段進行,而且我認為是有序的。
And so we have the three sites that are activated, as Douglas shared, we expect another site to be activated tomorrow. And in the reviews that I'm getting every single week, we have an additional three that have been selected and are very close to being activated, four that have been selected and that we expect could be activated in the near future and then so on and so on. So there's just a natural order to the activations.
因此,我們有三個已啟動的站點,正如道格拉斯所分享的,我們預計明天將啟動另一個站點。在我每週收到的評論中,我們還有另外三個已被選中並且非常接近被激活,四個已被選中並且我們預計可以在不久的將來實現激活,等等。因此激活有一個自然順序。
Douglas, I don't know if you want to add anything more.
道格拉斯,我不知道您是否還想補充什麼。
Douglas Faller - Chief Medical Officer
Douglas Faller - Chief Medical Officer
Well, you asked if there were any barriers and the answer to that is no. We're actually getting requests. The only barriers I would mention are we're getting requests internationally. And right now, we're simply not -- we want to activate our US sites and Canadian sites before thinking about international activations.
好吧,你問是否有任何障礙,答案是否定的。我們確實收到了請求。我想提到的唯一障礙是我們收到來自國際的請求。而現在,我們根本沒有——我們想先啟動我們的美國網站和加拿大網站,然後再考慮國際活化。
Operator
Operator
James Molloy, Alliance Global Partners.
聯盟全球合作夥伴的詹姆斯‧莫洛伊 (James Molloy)。
James Molloy - Analyst
James Molloy - Analyst
I had a question on the HRD screening, does that potentially slow or speed up? I know, obviously, the idea being you can look at a smaller group. But does that hamper the potential enrollment to go through this process?
我對 HRD 篩選有一個疑問,這是否有可能減慢或加快速度?我知道,顯然,這個想法是你可以專注於一個較小的群體。但這是否會妨礙潛在的入學者完成這個過程?
And just a follow-up on the previous question. Is the HRD positive -- if you have positive interim data -- is that only a potential for EU approval? I thought -- I apologize. I thought it was also potentially FDA filing as well -- fileable as well.
這只是上一個問題的後續答案。HRD 是否積極——如果您有積極的中期數據——這是否僅僅是獲得歐盟批准的潛力?我想——我道歉。我認為它也可能向 FDA 提交申請——也可以提交申請。
Douglas Faller - Chief Medical Officer
Douglas Faller - Chief Medical Officer
So, did you want to start?
那麼,你想開始嗎?
Stacy Lindborg - President, Chief Executive Officer, Director
Stacy Lindborg - President, Chief Executive Officer, Director
No. Please, go ahead.
不。請繼續。
Douglas Faller - Chief Medical Officer
Douglas Faller - Chief Medical Officer
So with respect to the second question, HRD as a biomarker would be certainly acceptable to the EU. The EU is as interested or EMA is as interested in having biomarker-driven approvals as the US is. And having said that, I actually forgot your first question, I apologize.
因此,對於第二個問題,HRD 作為生物標記肯定會被歐盟接受。歐盟或 EMA 對生物標記驅動的批准的興趣與美國一樣。話雖如此,我實際上忘記了你的第一個問題,我很抱歉。
Stacy Lindborg - President, Chief Executive Officer, Director
Stacy Lindborg - President, Chief Executive Officer, Director
It was the screening --
這是放映--
Douglas Faller - Chief Medical Officer
Douglas Faller - Chief Medical Officer
The screening. Excellent, excellent question. In some -- well, first of all, screening for HRD is standard of care for newly diagnosed patients with ovarian cancer because it determines their maintenance, doesn't determine their frontline therapy, but does determine what they would get in maintenance or if they would get maintenance.
放映。非常好,非常好的問題。在某些情況下 — — 首先,篩檢 HRD 是新診斷的卵巢癌患者的標準治療方法,因為它決定了他們的維持治療,並不決定他們的一線治療,但決定了他們將獲得什麼樣的維持治療或是否會獲得維持治療。
We have gone to great lengths to work with our partner, Foundation Medicine to deliver results from HRD extremely quickly. We have no interest in delaying treatment of patients or delaying patients starting on the trial. And so far, we've not had any issues with this. Foundation prioritizes our assays so that patients will get tested, randomized and treated quickly.
我們竭盡全力與我們的合作夥伴 Foundation Medicine 合作,以極其快速地交付 HRD 的成果。我們不想延後患者的治療或延後患者開始試驗。到目前為止,我們還沒有遇到任何問題。基金會優先考慮我們的檢測,以便患者能夠快速接受檢測、隨機分組和治療。
James Molloy - Analyst
James Molloy - Analyst
Excellent. And I know you guided to potentially having 20 sites open by year-end, again, I guess, funding dependent. Just a quick follow-up too on the Avastin trial. When can we potentially expect the next interim look or the next data set coming out of that trial? I know it's run through the Break Through Cancer Foundation, you have less control over that.
出色的。我知道您預計到年底可能會開設 20 個站點,我想,這也取決於資金。也只是對 Avastin 試驗進行快速跟進。我們什麼時候可以預期下一次中期觀察值或該試驗的下一組資料集?我知道它是透過突破癌症基金會來運作的,你對此的控制力較小。
Stacy Lindborg - President, Chief Executive Officer, Director
Stacy Lindborg - President, Chief Executive Officer, Director
We have a call with the study PI actually coming up very soon. The last time we met to discuss the potential, there were some cutting-edge assays that he was particularly interested in, and we're excited to talk to him about the viability of translational data from the trial being able to be released in a scientific forum, but we're in regular contact with the sites. So, do you want to add anything?
我們很快就會與研究 PI 進行通話。上次我們開會討論潛力時,他對一些尖端檢測方法特別感興趣,我們很高興與他討論在科學論壇上發布試驗轉化數據的可行性,但我們會定期與相關機構聯繫。那麼,您想添加什麼嗎?
Douglas Faller - Chief Medical Officer
Douglas Faller - Chief Medical Officer
Well, I would just add that we've already gotten some very useful information from this trial. One of our goals for this was to determine if and how we can use bevacizumab in combination with IMNN-001. Bev, as you know, is an anti-angiogenic antibody. It's used in ovarian cancer to some extent, but has never improved survival on its own.
好吧,我只想補充一點,我們已經從這次試驗中獲得了一些非常有用的信息。我們的目標之一是確定是否以及如何將貝伐單抗與 IMNN-001 結合使用。如您所知,Bev 是一種抗血管生成抗體。它在一定程度上用於治療卵巢癌,但它本身從未提高存活率。
But it's something that we've been interested in combining with IMNN-001. So we established that we can combine, the combination is safe. And we've also shown in early -- very early findings that we have a second look laparoscopy, what appears to be benefit from -- in the patients who got IMUNON and both arms getting bevacizumab.
但我們一直有興趣將其與 IMNN-001 結合。所以我們確定我們可以結合,而且這種結合是安全的。而且我們也在早期——非常早期的研究結果中表明,我們對腹腔鏡進行了第二次檢查,這似乎對接受 IMUNON 治療的患者和接受貝伐單抗治療的患者都有好處。
James Molloy - Analyst
James Molloy - Analyst
Great. And final question would be, I know it's hard to discuss, but could you talk a little bit about the potential partnership environment and how things are looking in the current overall environment?
偉大的。最後一個問題是,我知道這很難討論,但您能否談談潛在的合作環境以及當前整體環境的情況?
Stacy Lindborg - President, Chief Executive Officer, Director
Stacy Lindborg - President, Chief Executive Officer, Director
Yeah. I mean it is hard to go much more than what I've already shared in my prepared remarks, Jim. But we are facing interest. In fact, we're even getting incoming calls. And again, as I shared in my prepared remarks, we have an interest in any business opportunity that makes sense for our company and our shareholders, which include dimensions of accelerating development in geographic locations outside of the US.
是的。我的意思是,吉姆,我很難再分享比我在準備好的發言中已經分享的內容更多的內容。但我們面臨利息。事實上,我們甚至接到了來電。正如我在準備好的演講中所說,我們對任何對我們公司和股東有意義的商業機會都感興趣,其中包括在美國以外地理位置加速發展的維度。
And thinking about new indications that could proceed with our technology platform, we know that it is a very exciting and very broadly applicable to many large tumors. I'm sure Douglas would love to talk to you about our thoughts and dreams along those lines. And of course, to come alongside as a partner in our Phase 3 plan.
考慮到我們的技術平台可以實現的新適應症,我們知道這是一個非常令人興奮的領域,並且可以廣泛適用於許多大型腫瘤。我相信道格拉斯很樂意與您談論我們的想法和夢想。當然,我們也將作為合作夥伴參與我們的第三階段計劃。
So we are having discussions. We are pursuing follow-up conversations, but they do take time. So unfortunately, I can't go into any greater detail at this time.
所以我們正在進行討論。我們正在進行後續對話,但這確實需要時間。因此很遺憾,我現在無法透露更多細節。
Operator
Operator
(Operator Instructions) We have no further questions at this time. I would now like to turn the conference back over to Dr. Stacy Lindborg for any closing remarks.
(操作員指示)我們目前沒有其他問題。現在,我想將會議交還給 Stacy Lindborg 博士,請她做最後發言。
Stacy Lindborg - President, Chief Executive Officer, Director
Stacy Lindborg - President, Chief Executive Officer, Director
I want to thank you all for your questions. Maybe just a couple of concluding remarks. We remain focused on funding to fortify our position and to progress IMNN-001 through our pivotal trial, OVATION 3. We aim to fund this trial through partnerships and equity iteratively building on catalysts and milestones.
我想感謝大家提出的問題。也許只是幾句總結性的評論。我們仍然專注於資金,以鞏固我們的地位並透過關鍵試驗 OVATION 3 推進 IMNN-001。我們的目標是透過合作夥伴關係和股權,在催化劑和里程碑的基礎上持續為此試驗提供資金。
And as we advance ovarian cancer treatment and our DNA-based technology platform, along with vaccine innovations more broadly, we can tell you we are eager to share upcoming data and updates. We thank you for your insightful comments and questions on this call and look forward to future discussions. So thank you for joining and for your interest in IMUNON.
隨著我們推進卵巢癌治療和基於 DNA 的技術平台以及更廣泛的疫苗創新,我們可以告訴您,我們渴望分享即將到來的數據和更新。我們感謝您在本次電話會議上提出的深刻評論和問題,並期待未來的討論。感謝您的加入以及對 IMUNON 的關注。
Operator
Operator
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。