SIGA Technologies Inc (SIGA) 2025 Q2 法說會逐字稿

Welcome to the SIGA business update call.

歡迎參加 SIGA 業務更新電話會議。

Before we turn the call over to SIGA management, please note that any forward-looking statements made during this call are based on management's current expectations and observations and are subject to risks and uncertainties that could cause actual results to differ from the forward-looking statements. SIGA does not undertake any obligation to update publicly any forward-looking statements to reflect events or change circumstances after this call.

在我們將電話轉交給 SIGA 管理層之前，請注意，本次電話會議中做出的任何前瞻性陳述均基於管理層當前的預期和觀察，並受可能導致實際結果與前瞻性陳述不同的風險和不確定性的影響。SIGA 不承擔任何義務公開更新任何前瞻性聲明以反映本次電話會議後的事件或變更情況。

For a discussion of factors that could cause results to differ, please see the company's filings with the Securities and Exchange Commission, including, without limitation, the company's annual report on Form 10-K for the year ended December 31, 2024, and its subsequent reports on Form 10-Q and Form 8-K.

有關可能導致結果不同的因素的討論，請參閱本公司向美國證券交易委員會提交的文件，包括但不限於本公司截至 2024 年 12 月 31 日的 10-K 表年度報告以及後續的 10-Q 表和 8-K 表報告。

With that, I will turn the call over to Diem Nguyen, Chief Executive Officer of SIGA. Diem?

說完這些，我會把電話轉給 SIGA 執行長 Diem Nguyen。迪姆？

Good afternoon, everyone, and thank you for joining today's call and a review of our business results for the second quarter of 2025. I am joined by Dan Luckshire, our Chief Financial Officer, and we appreciate this opportunity to provide an update on our company. After the update, we'll be happy to answer your questions.

大家下午好，感謝大家參加今天的電話會議並回顧我們 2025 年第二季的業務業績。我們的財務長 Dan Luckshire 也與我們一同出席，我們很高興有機會向大家介紹公司的最新動態。更新後，我們將很樂意回答您的問題。

At the midpoint of 2025, I'm pleased to share that SIGA continues to make steady progress as we advance our strategic initiatives. The evolving global landscape calls for agility and focus, and our team remains deeply committed to strengthening our role in the global health security and delivering enduring value to our shareholders.

在 2025 年中期，我很高興地告訴大家，SIGA 在推動策略舉措的過程中繼續取得穩步進展。不斷變化的全球格局需要敏捷性和專注力，我們的團隊仍然堅定致力於加強我們在全球衛生安全中的作用並為我們的股東提供持久的價值。

In the second quarter of this year, we achieved two important positive results, significant product revenues and a significant increase to the development funding under the BARDA 19C contract. In the quarter, product revenues totaled approximately $79 million, comprising of $53 million of oral TPOXX and $26 million of IV TPOXX delivered to the US Strategic National Stockpile, or SNS. These deliveries fulfilled the $70 million of orders outstanding at year-end 2024.

今年第二季度，我們取得了兩項重要的正面成果，即產品收入的大幅成長以及BARDA 19C合約項下開發資金的大幅增加。本季度，產品收入總計約 7,900 萬美元，其中包括交付給美國國家戰略儲備庫（SNS）的價值 5,300 萬美元的口服 TPOXX 和價值 2,600 萬美元的靜脈注射 TPOXX。這些交付滿足了 2024 年底未完成的 7,000 萬美元訂單。

At the end of the second quarter, there were approximately $26 million of remaining outstanding orders from the US government. This outstanding balance relates to the March 2025 US government exercise of an option under the 19C contract to procure an additional $26 million of IV TPOXX. We note this option exercised during our last investor call and expect to deliver this order in 2026.

截至第二季末，美國政府剩餘未償訂單約2,600萬美元。該未償餘額與 2025 年 3 月美國政府根據 19C 合約行使選擇權有關，該選擇權將採購額外價值 2,600 萬美元的 IV TPOXX。我們注意到該選擇權已在上次投資者電話會議中行使，預計將於 2026 年交付該訂單。

Also during this quarter, we received commitments from the US government to provide $27 million of incremental development funding. This increase in development funding occurred in two buckets. In April, the government modified the 19C contract by adding $14 million in funding to support manufacturing activities, which we expect to occur over the next two to three years. Most recently in June, the government committed to an additional $13 million of development funding to further support the pediatric program.

此外，在本季度，我們獲得了美國政府的承諾，將提供 2,700 萬美元的增量開發資金。開發資金的增加體現在兩個方面。今年 4 月，政府修改了 19C 合同，增加了 1400 萬美元的資金來支持製造活動，我們預計這將在未來兩到三年內完成。最近在 6 月份，政府承諾額外提供 1,300 萬美元的發展資金，以進一步支持兒科計畫。

We believe these recent actions surrounding IV TPOXX in procurement and additional manufacturing support and with respect to the pediatric program reflect the continued importance of maintaining a full complement of TPOXX formulations in the stockpile as treatment options for smallpox.

我們相信，最近圍繞 IV TPOXX 在採購和額外製造支援以及兒科專案方面採取的這些行動反映了在庫存中維持全套 TPOXX 製劑作為天花治療選擇的重要性。

Maintaining both oral and IV formulations ensures the flexibility and response strategies as the IV formulation is an important alternative for those who are unable to swallow capsules. Given the severity of smallpox, we view these investments as a strong signal of the United States government's continued commitment to the national health preparedness and recognition of the critical role antivirals play. We're proud to support these efforts.

保持口服和靜脈注射兩種劑型可確保靈活性和應對策略，因為靜脈注射劑型對於無法吞嚥膠囊的人來說是一個重要的替代方案。鑑於天花的嚴重性，我們認為這些投資強烈表明美國政府繼續致力於國家衛生防備，並認識到抗病毒藥物的關鍵作用。我們很榮幸能夠支持這些努力。

Looking ahead beyond our current 19C contract. We continue to engage constructively with the US government. Our goal remains clear to establish a new comprehensive long-term agreement that reflects the value of TPOXX. Such a framework will not only strengthen the nation's bioterrorism preparedness, but also advance our collective commitment to global health security and public health resilience.

展望我們目前的 19C 合約的未來。我們繼續與美國政府進行建設性接觸。我們的目標仍然明確，即建立一項能夠體現 TPOXX 價值的新的全面長期協議。這樣的框架不僅將加強國家的生物恐怖主義防範能力，而且還將促進我們對全球衛生安全和公共衛生復原能力的集體承諾。

As I've highlighted during prior calls, antivirus play a critical role alongside vaccines, training individuals who are unvaccinated or who may not benefit from vaccination. With rising threats from emerging infectious diseases and bioterrorism, this dual approach is increasingly essential. In a comprehensive preparedness plan, strategic stockpiling of medical countermeasures is critical to ensuring a rapid response in crisis.

正如我在先前的電話會議中所強調的那樣，防毒技術與疫苗一樣發揮著至關重要的作用，可以為未接種疫苗或可能無法從疫苗接種中受益的個人提供培訓。隨著新興傳染病和生物恐怖主義威脅的不斷增加，這種雙重方法變得越來越重要。在全面的緊急準備計畫中，策略性地儲備醫療對策對於確保在危機中快速做出反應至關重要。

Importantly, given our long-standing partnership with the US government and our government's demonstrated commitment to proactive biodefense, we remain prepared to respond to an RFP when issued and to complete a procurement agreement in an efficient manner.

重要的是，鑑於我們與美國政府的長期合作關係以及我們政府對主動生物防禦的承諾，我們隨時準備在發布 RFP 時做出回應並以有效的方式完成採購協議。

Internationally, we have been engaging with stakeholders on critical role by defense in shaping resilient health security frameworks. Strategic stockpiling, supported by multi-year funding dedicated to crisis preparedness, is essential given evolving security considerations. Our aim is to help ensure that various regions of the world are not caught unprepared if smallpox outbreak becomes an unfortunate reality.

在國際上，我們一直與利害關係人就國防在建立有彈性的衛生安全框架方面發揮的關鍵作用進行接觸。鑑於不斷變化的安全考慮，戰略儲備至關重要，並由專門用於危機防範的多年期資金支持。我們的目標是幫助確保當天花疫情不幸爆發時，世界各地不會措手不及。

Regarding international markets, I'd like to discuss the regulatory development in Europe. At the end of July, the EMA's Committee of Medicinal Products for Human Use, or CHMP, commenced a referral procedure for tecovirimat. The CHMP raised questions about the product's efficacy in treating Mpox following a review of the data from the recent Mpox clinical trials, including PALM 007 and STOMP.

關於國際市場，我想討論歐洲的監管發展。7 月底，EMA 人用藥物委員會 (CHMP) 啟動了 tecovirimat 的轉診程序。在審查了最近的 Mpox 臨床試驗（包括 PALM 007 和 STOMP）的數據後，CHMP 對該產品治療 Mpox 的功效提出了質疑。

As part of the referral procedure, the CHMP has provided a detailed set of questions largely focused on the Mpox trials and will evaluate all non-clinical and clinical data to determine if the product maintains a positive benefit risk ratio for its approved indications.

作為轉診程序的一部分，CHMP 提供了一組詳細的問題，主要集中在 Mpox 試驗上，並將評估所有非臨床和臨床數據，以確定該產品是否對其獲批適應症保持了積極的效益風險比。

Our priority right now is to provide thorough science-based responses to the agency's questions and fully support the referral procedure. As a reminder, tecovirimat was developed as a smallpox treatment with the goal of reducing mortality and is backed by a robust and comprehensive data package. It has been studied extensively and has demonstrated a strong safety profile in humans.

我們現在的首要任務是對該機構的問題提供全面的、基於科學的答复，並全力支持轉介程序。提醒一下，tecovirimat 是作為天花治療方法開發的，目的是降低死亡率，並有強大而全面的資料包支援。它已被廣泛研究並被證明對人類具有很強的安全性。

In preclinical trials, tecovirimat significantly reduced mortality and viral load across four pivotal studies in non-human primates and two in rabbits, each of which it is important to note was designed to replicate smallpox in humans. It remains the only antiviral approved in the EU for smallpox treatment and it stands out for its strong safety profile.

在臨床前試驗中，tecovirimat 在四項非人靈長類動物關鍵研究和兩項兔子關鍵研究中顯著降低了死亡率和病毒量，值得注意的是，每項研究都旨在複製人類的天花。它仍然是歐盟批准用於治療天花的唯一抗病毒藥物，並且因其強大的安全性而脫穎而出。

Safety has been demonstrated in about 10,000 tecovirimat recipients across more than 20 clinical trials, including normal healthy volunteers and patients with Mpox in open-label or double-blinded placebo-controlled studies. Should there ever be a smallpox outbreak, we believe tecovirimat will serve as a critical countermeasure for mass distribution given its strong safety profile.

在超過 20 項臨床試驗中，約 10,000 名接受 tecovirimat 治療的患者（包括正常健康志願者和 Mpox 患者）已證明其安全性，這些試驗是在開放標籤或雙盲安慰劑對照研究中進行的。我們相信，如果真的爆發天花，tecovirimat 憑藉其強大的安全性將成為大規模分發的關鍵對策。

Turning to our late-stage pipeline. We continue to advance TPOXX post-exposure prophylaxis program for smallpox, or PEP. Collaboration with the CDC and consultation with FDA remains active as the CDC continues to move towards completing the required analysis of the samples collected to support the study's immunogenicity objective. The FDA has remained closely engaged with us on this program, offering real-time guidance that we believe has strengthened our regulatory plan.

轉向我們的後期管道。我們繼續推動TPOXX天花暴露後預防計畫（PEP）。隨著 CDC 繼續努力完成對所收集樣本所需的分析以支持研究的免疫原性目標，與 CDC 的合作和與 FDA 的諮詢仍在繼續。FDA 一直與我們密切合作，提供即時指導，我們相信這加強了我們的監管計劃。

The CDC continues to expect to complete their work during the fourth quarter. As such, we're targeting an FDA submission for the PEP indication in 2026.

CDC 仍預計將在第四季度完成其工作。因此，我們計劃在 2026 年向 FDA 提交 PEP 適應症申請。

Also in our pipeline, our pediatric program continues to move forward in partnership with the Biomedical Advanced Research and Development Authority, or BARDA, within the US Department of Health and Human Services under the Administration of Strategic Preparedness and Response, or ASPR. This initiative is designed to address an important unmet need, providing a treatment option for children too small for the current oral formulation of TPOXX.

此外，我們正在籌備的兒科計畫也將繼續與美國衛生與公眾服務部戰略防範與應變管理局（ASPR）管轄下的生物醫學高級研究與發展局（BARDA）合作推進。該計劃旨在解決一個重要的未滿足需求，為體型太小而無法使用目前口服 TPOXX 藥物的兒童提供治療選擇。

Clinical trial material has been manufactured, and we remain on track to submit an IND in the second half of this year with the trial targeted to begin thereafter. As we look toward the second half of the year, our focus remains clear: sustaining a strong financial foundation and executing our strategic priorities with discipline. We continue to concentrate on the core areas that we have consistently delivered results and position us for durable success.

臨床試驗材料已經製造完成，我們仍有望在今年下半年提交 IND，並計劃隨後開始試驗。展望下半年，我們的重點依然明確：維持強勁的財務基礎並嚴格執行我們的策略重點。我們將繼續專注於我們始終如一地取得成果並為我們取得持久成功奠定基礎的核心領域。

First, continuing our partnership with the US government; second, advancing regulatory approvals of TPOXX in new indications; third, cultivating strategic partnerships to expand global access to TPOXX; and fourth, leveraging our capabilities to move into complementary therapeutic areas.

首先，繼續與美國政府合作；其次，推動TPOXX新適應症的監管批准；第三，建立戰略合作夥伴關係，擴大TPOXX的全球覆蓋範圍；第四，利用我們的能力進入互補治療領域。

In closing, we believe SIGA remains well equipped to continue its progress over time, building on its long history of public and private successes with a focused strategy, financial discipline, differentiated TPOXX franchise,and a proven track record. We're moving forward with purpose, staying true to our role in supporting global preparedness and driving meaningful shareholder returns.

最後，我們相信，SIGA 憑藉專注的策略、財務紀律、差異化的 TPOXX 特許經營權和良好的業績記錄，憑藉其長期以來在公共和私人領域的成功經驗，將繼續取得進步。我們正有目標地前進，忠於我們在支持全球防範和推動有意義的股東回報方面的角色。

With that, I'll turn it over to Dan to review the financial results in more detail. Dan?

說完這些，我將把責任交給丹，讓他更詳細地審查財務結果。擔？

Thanks, Diem. As noted earlier in the call, SIGA's product sales for the three months ended June 30, 2025, were $79 million. Product sales for the quarter comprised $53 million of oral TPOXX sales and $26 million of IV TPOXX sales to the US government under the 19C BARDA contract. For the six months ended June 30, 2025, product sales are $85 million.

謝謝，Diem。正如電話會議早些時候提到的，SIGA 截至 2025 年 6 月 30 日的三個月的產品銷售額為 7900 萬美元。本季的產品銷售額包括根據 19C BARDA 合約向美國政府銷售的 5,300 萬美元口服 TPOXX 和 2,600 萬美元靜脈注射 TPOXX。截至 2025 年 6 月 30 日的六個月，產品銷售額為 8,500 萬美元。

In addition to product sales, the company has research and development revenues of approximately $2 million and $3 million for the three and six months ended June 30, 2025, respectively.

除產品銷售外，截至 2025 年 6 月 30 日的三個月和六個月，該公司的研發收入分別約為 200 萬美元和 300 萬美元。

As a supplemental note, there are $26 million of remaining outstanding orders as of June 30. This amount reflects the $26 million IV TPOXX order received in the first quarter of this year under the 19C contract, which is targeted for delivery in 2026. Pre-tax operating income for the quarter, which excludes interest income and taxes, is approximately $46 million. For the six months ended June 30, 2025, pre-tax operating income is approximately $43 million.

補充說明一下，截至 6 月 30 日，剩餘未完成訂單金額為 2,600 萬美元。該金額反映了今年第一季根據 19C 合約收到的價值 2,600 萬美元的 IV TPOXX 訂單，該訂單計劃於 2026 年交付。本季度稅前營業收入（不含利息收入和稅金）約為 4,600 萬美元。截至 2025 年 6 月 30 日的六個月，稅前營業收入約為 4,300 萬美元。

Net income for the quarter as well as the six months ended June 30, 2025, is approximately $35 million. In turn, fully diluted income per share for the three and six months ended June 30, 2025, is $0.49 per share. The company continues to maintain a strong balance sheet. At June 30, 2025, the company had a cash balance of approximately $182 million and no debt.

本季以及截至 2025 年 6 月 30 日的六個月的淨收入約為 3,500 萬美元。反過來，截至 2025 年 6 月 30 日的三個月和六個月的每股完全攤薄收益為每股 0.49 美元。該公司繼續保持強勁的資產負債表。截至 2025 年 6 月 30 日，該公司的現金餘額約為 1.82 億美元，且沒有債務。

This concludes the financial update. At this point, I will turn the call back to Diem.

財務更新到此結束。現在，我將把電話轉回給 Diem。

Thank you, Dan. With that, we would like to open the call up for questions.

謝謝你，丹。現在，我們開始回答問題。

(Operator Instructions) Jyoti Prakash, Edison Group.

（操作員指示） Jyoti Prakash，愛迪生集團。

First of all, congratulations on the strong sales performance in the quarter. My first question is related to the $13 million BARDA funding for the pediatric program. How do you plan to deploy these funds? And if you can comment on the likely trial design and the data required for a possible approval.

首先，恭喜本季強勁的銷售業績。我的第一個問題與 BARDA 為兒科計畫提供的 1,300 萬美元資助有關。您計劃如何部署這些資金？您是否可以對可能的試驗設計和可能獲得批准所需的數據進行評論？

Jyoti, nice to hear from you, and thanks so much for this question. This is a really important program for SIGA because we believe it is important to be able to develop a formulation to protect a very vulnerable population.

喬蒂，很高興收到你的來信，非常感謝你提出這個問題。對於 SIGA 來說，這是一個非常重要的項目，因為我們相信能夠開發配方來保護非常脆弱的人群非常重要。

BARDA has been very supportive of this program throughout the development process, and this additional funding reemphasizes the importance of tecovirimat to the US government. This investment will fund development activities up to regulatory filings.

BARDA在整個開發過程中一直非常支持該項目，這筆額外資金再次強調了tecovirimat對美國政府的重要性。此項投資將資助直至監管備案的開發活動。

As it relates to the study design, by the way of the background, in 2023, we initiated and concluded a Phase I study that evaluated an oral suspension formulation prototype in healthy adults for the development of pediatric powder for oral suspension formulation. That study looked at a range of factors with a primary goal to understand how the drug in this formulation behaves in the body after a single dose compared to TPOXX capsule.

就研究設計而言，就背景而言，我們於 2023 年啟動並完成了一項 I 期研究，該研究評估了健康成人口服混懸液製劑原型，以開發兒科口服混懸液製劑粉末。該研究檢視了一系列因素，主要目的是了解與 TPOXX 膠囊相比，該製劑中的藥物在單次服用後在體內的表現如何。

While we're now preparing for the follow-up trial, which will evaluate a refined formulation designed to deliver tecovirimat dose appropriate for pediatric use, it will be a single-dose crossover study that also examines how different meal types affect absorption. This ensures that children receive a safe and effective dose that mirrors adult exposure levels.

目前，我們正在為後續試驗做準備，該試驗將評估一種旨在提供適合兒科使用的特可維拉劑量的精製配方，這將是一項單劑量交叉研究，還將研究不同膳食類型如何影響吸收。這確保兒童獲得與成人接觸程度相同的安全有效的劑量。

Thank you for the explanation. My second question relates to your international growth efforts. You mentioned the CHMP requesting additional data from the Mpox trial. And if you look at the recent quarters, you've had strong order demand and you have delivered significant orders. So I just want to understand this new data request, how does this impact your plans for international growth and expansion?

謝謝你的解釋。我的第二個問題與您的國際成長努力有關。您提到 CHMP 要求從 Mpox 試驗中取得更多數據。如果你看一下最近幾季的情況，你會發現訂單需求強勁，而且已經交付了大量訂單。所以我只是想了解這個新的數據請求，它對您的國際成長和擴張計劃有何影響？

This is Dan. I'll take that question. Maybe as a starting point, the background is that we took over the international promotion and marketing from Meridian last summer. Over the past year, we have been spending considerable time strengthening and building relationships with current and potential customers around the globe. And all this effort has really been centered on expanding our international business and ensuring countries are prepared in case of a smallpox outbreak. As you're aware, there's a lot of preparation and groundwork that's part of the international effort.

這是丹。我來回答這個問題。也許作為一個起點，背景是去年夏天我們從 Meridian 接管了國際推廣和行銷。在過去的一年裡，我們花了大量時間來加強和建立與全球現有和潛在客戶的關係。所有這些努力實際上都集中在擴大我們的國際業務和確保各國為天花爆發做好準備。如您所知，作為國際努力的一部分，需要做大量的準備和基礎工作。

Given the current geopolitical instability and the stockpile strategies for these individual countries, we do believe that we are building an international business that has significant potential.

鑑於當前的地緣政治不穩定以及這些國家的儲備策略，我們確實相信我們正在建立一個具有巨大潛力的國際業務。

In terms of timing of future sales activity, we expect international orders to continue to be lumpy. With that context, I would highlight that we have sold $135 million of oral TPOXX to 30 countries since 2020. And we do believe that that shows the depth and the scope of the international opportunity.

就未來銷售活動的時間而言，我們預期國際訂單將持續不穩定。在此背景下，我想強調的是，自 2020 年以來，我們已向 30 個國家銷售了價值 1.35 億美元的口服 TPOXX。我們確實相信，這顯示了國際機會的深度和廣度。

Thanks for the clarification, Dan. Moving on to the US market. You talked briefly about the RFP process and your ongoing conversations. But do you have any further clarity on the timelines for the RFP?

謝謝你的澄清，丹。進軍美國市場。您簡要地談到了 RFP 流程和正在進行的對話。但是，您對 RFP 的時間表還有進一步的了解嗎？

And secondly, assuming if the RFP is received in the second half of the year, what would be the typical lead time between order receipt and delivery?

其次，假設如果在下半年收到 RFP，那麼從訂單接收到交付的典型交付週期是多長？

This is Dan. I'll also respond to that question. I think there's two components in there, and it's mostly sort of focused on some of the mechanics. We had some prepared remarks on this. But as you can imagine, it's difficult for us to speculate on the exact timing and form of the US government RFP.

這是丹。我也會回答這個問題。我認為其中有兩個組成部分，並且主要集中於一些機制。我們對此已經準備好了一些發言。但正如您所想像的，我們很難推測美國政府 RFP 的具體時間和形式。

What we can say is that we do believe that we have seen recent confirmation of the US government's commitment to biodefense this quarter with the combination of the deliveries of TPOXX, which have been substantial and the two commitments for development funding that we've talked about both in our prepared remarks as well as our press release, that development funding adding up to $27 million, which is a meaningful number.

我們可以說的是，我們確實相信，我們最近已經看到了美國政府本季對生物防禦承諾的確認，其中包括大量的 TPOXX 交付以及我們在準備好的評論和新聞稿中談到的兩項開發資金承諾，這筆開發資金總計 2700 萬美元，這是一個有意義的數字。

With that backdrop, our focus does remain on fostering the strong partnership that we've had for a very long time, really over a decade. And this ongoing partnership plays a vital role in supporting what we believe is national security and public health efforts. And we really think that's valuable. It's worth a lot. So overall, we do believe we're well positioned to engage with the US government on RFP when they are ready.

在這樣的背景下，我們的重點仍然是培養我們長期以來（實際上超過十年）建立的強大夥伴關係。我們認為，這種持續的夥伴關係在支持國家安全和公共衛生工作方面發揮著至關重要的作用。我們確實認為這很有價值。它非常有價值。因此，總體而言，我們確實相信，當美國政府做好準備時，我們有能力就 RFP 與其接觸。

In terms of process, I think there was a part of your question about just sort of timing on process. I would say that there are many variables. But in short, maybe I could just sort of at least use the 2018 process that was -- these are long-dated contracts, and that was the last contract we dealt with the United States government that lasted until recently in terms of orders.

就流程而言，我認為您的問題有一部分涉及流程的時間表。我想說有很多變數。但簡而言之，也許我至少可以使用 2018 年的流程 - 這些都是長期合同，這是我們與美國政府處理的最後一份合同，就訂單而言一直持續到最近。

In that process, in 2018, there's an RFP that was put out. Now granted, in this situation, the RFP could be both open competition or it could be sole source justification. So a variety of different forms. But in 2018, there's an RFP that was put out. And then after the RFP, we would enter a negotiation process.

在此過程中，我們於 2018 年發布了一份 RFP。現在可以肯定的是，在這種情況下，RFP 既可以是公開競爭，也可以是唯一來源的依據。因此有多種不同的形式。但在 2018 年，我們發布了一份 RFP。在 RFP 之後，我們將進入談判流程。

In 2018, from start to finish in terms of negotiation, that took six months. Having said that, the timeframe could vary in either direction given the administration change. So we would be as efficient as possible. We've gone through many procurement processes. And so we will be very efficient and we are prepared. And we're not aware of any impediments to the negotiation process going much faster than six months if the US government desires it.

2018年，談判從開始到結束花了六個月的時間。話雖如此，考慮到政府的變動，時間框架可能會改變。所以我們會盡量提高效率。我們經歷了許多採購流程。因此我們將非常有效率並且做好準備。如果美國政府希望的話，我們不知道會有什麼障礙阻礙談判進程在六個月內迅速推進。

Thank you, Dan. And I have one final question, and this is related to the preclinical monoclonal antibody program, which was licensed in late 2024. Just wanted to understand what's the current status of the program? And what are your plans for clinical development?

謝謝你，丹。我還有最後一個問題，這與 2024 年底獲得許可的臨床前單株抗體計畫有關。只是想了解該計劃的當前狀態？您對臨床開發有什麼計畫？

Thank you, Jyoti. This is Diem. I'll take that. First and foremost, I would just begin by saying that we remain quite enthusiastic about the opportunity to expand our pipeline with this portfolio of preclinical full-human monoclonal antibodies, which can be used as a potential treatment for a broad range of orthopoxviruses, both as a therapeutic as well as a prophylactic measure. These monoclonals have demonstrated promise in preclinical models.

謝謝你，喬蒂。這是 Diem。我會接受的。首先，我想說的是，我們仍然非常熱衷於利用這一系列臨床前全人單株抗體來擴展我們的產品線，這些抗體可以作為多種正痘病毒的潛在治療方法，既可以作為治療手段，也可以作為預防措施。這些單株抗體在臨床前模型中已顯示出良好的前景。

And we are looking to potentially execute on programs to determine the benefits of using this as a stand-alone treatment or in combination with TPOXX. We're currently working through our process to determine the best path forward for these assets from a development and manufacturing perspective, and we'll keep you apprised with our plans as we progress.

我們正在尋求潛在地執行計劃，以確定將其作為獨立治療方法或與 TPOXX 結合使用的好處。我們目前正在努力從開發和製造的角度確定這些資產的最佳前進道路，我們將隨時向您通報我們的進度計劃。

(Operator Instructions) And there are no further questions at this time. I will now hand the call back to Diem Nguyen for any closing remarks.

（操作員指示）目前沒有其他問題。現在我將把電話轉回給 Diem Nguyen，請他做最後發言。

Thank you. I'd like to close by thanking everyone here for making the time to join today's call and for your ongoing interest in SIGA. We look forward to speaking to you again on our third-quarter call. Have a good evening.

謝謝。最後，我要感謝在座的各位抽出時間參加今天的電話會議，並感謝你們對 SIGA 的持續關注。我們期待在第三季電話會議上再次與您交談。祝您晚上愉快。

And this concludes today's call. Thank you for participating. You may now disconnect.

今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。