SIGA Technologies Inc (SIGA) 2024 Q3 法說會逐字稿

Good afternoon, ladies and gentlemen and welcome to the SIGA Technologies third-quarter, 2024 Earnings call at this time. (Operator Instruction)

女士們、先生們，下午好，歡迎此時參加 SIGA Technologies 2024 年第三季財報電話會議。（操作員說明）

This call is being recorded on Thursday, November 7, 2024. I would now like to turn the conference over to Diem Nguyen, Chief Executive Officer. Please go ahead.

本次通話錄音時間為 2024 年 11 月 7 日星期四。我現在將會議交給執行長 Diem Nguyen。請繼續。

Good afternoon, everyone, and thank you for joining today's call and the review of our business results for the third-quarter of '2024. 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，感謝您參加今天的電話會議並回顧我們 2024 年第三季的業務業績。我們的財務長 Dan Luckshire 也加入了我的行列，我們很高興有機會介紹我們公司的最新情況。更新後，我們將很樂意回答您的問題。

I'm pleased to share that with $122 million of procurement orders secured in the third quarter. They could continue to sustain its strong business momentum. These new orders position us well to extend our strong year-to-date revenue performance which is outpacing revenues in the comparable period last year.

我很高興與大家分享第三季獲得的 1.22 億美元採購訂單。他們可以繼續保持強勁的業務勢頭。這些新訂單使我們能夠很好地延續年初至今的強勁收入業績，該業績超過了去年同期的收入。

Additionally, I would like to note that our product sales so far this year include a diverse mix of revenue sources led by oral and IV TPOXX deliveries to the U.S. Strategic National Stockpile. Internationally year-to-date sales include deliveries to new customers one of which represents our first sales of oral TPOXX in Africa in response to a request from the Ministry of Health in Morocco.

此外，我想指出的是，今年到目前為止，我們的產品銷售包括多種收入來源，其中包括向美國戰略國家庫存交付口服 TPOXX 和 IV TPOXX。今年迄今的國際銷售包括向新客戶的交付，其中之一是我們應摩洛哥衛生部的要求在非洲首次銷售口服 TPOXX。

At the end of the third-quarter, outstanding procurement orders were $146 million.

截至第三季末，未完成採購訂單為1.46億美元。

This significant balance of outstanding orders positions us to recognize substantial revenues in the fourth quarter of '2024 and into '2025. Demonstrating the continued strong demand for TPOXX.

未完成訂單的巨大餘額使我們能夠在 2024 年第四季和 2025 年確認大量收入。顯示對 TPOXX 的持續強勁需求。

Please note that this outstanding order balance includes most of the $112.5 million order from the U.S. government under the 19C contract announced in July which we began shipping towards the end of September and continued into October.

請注意，這項未完成訂單餘額包括根據 7 月宣布的 19C 合約從美國政府獲得的 1.125 億美元訂單的大部分，我們於 9 月底開始發貨，並持續到 10 月。

We believe year-to-date sales as well as the outstanding orders built over the past several months underscore our company's financial strength and resilience.

我們相信，今年迄今的銷售額以及過去幾個月的未完成訂單凸顯了我們公司的財務實力和彈性。

Our focus continues to be on SIGA's long-term performance as we have multiple strategic opportunities to drive and expand our revenue base and earnings over time.

我們的重點仍然是 SIGA 的長期業績，因為我們擁有多個策略機會來推動和擴大我們的收入基礎和收益。

Looking forward, we believe securing a new contract for the continuing supply of TPOXX to the strategic national stockpile or SNS represents a significant opportunity to enhance our company's momentum and long-term earnings potential as well as do our part to advance our nation's public health preparedness.

展望未來，我們相信，獲得向國家戰略儲備或SNS 持續供應TPOXX 的新合約是一個重大機會，可以增強我們公司的發展勢頭和長期盈利潛力，並為推進我們國家的公共衛生準備工作盡自己的一份力量。

We believe our ongoing productive conversations with a wide range of government officials positions as well as we prepare for the administration of strategic preparedness and response known as ASPR to take the first step in the process, which we expect to result in a new contract for TPOXX.

我們相信，我們與廣泛的政府官員進行的持續富有成效的對話，以及我們為稱為ASPR 的戰略準備和響應管理做好準備，邁出了這一過程的第一步，我們預計這將為TPOXX帶來一份新合約。

As a reminder, ASPR is within the U.S. Department of Human Services or HHS and houses the Center for the Biomedical Advanced Research and Development Authority or BARDA and the SNS.

提醒一下，ASPR 隸屬於美國人類服務部 (HHS)，並設有生物醫學高級研究與發展局 (BARDA) 中心和 SNS。

We believe our dedicated team is well prepared to support this crucial public health initiative.

我們相信，我們的專業團隊已做好充分準備來支持這項重要的公共衛生措施。

And based on these conversations, we are confident in the U.S. government's enduring commitment to maintaining robust public health preparedness and a supply of antiviral therapies to treat smallpox.

基於這些對話，我們對美國政府對維持強有力的公共衛生準備和提供治療天花的抗病毒療法的持久承諾充滿信心。

Importantly, at SIGA, we believe that the effective pandemic preparedness requires both vaccines and antivirals as neither alone can fully address the complexity of an outbreak.

重要的是，在 SIGA，我們認為有效的疫情防範需要疫苗和抗病毒藥物，因為兩者都無法完全解決疫情爆發的複雜性。

While vaccines play an important role, preventing disease and building immunity, they may not be immediately available or effective for everyone.

雖然疫苗在預防疾病和增強免疫力方面發揮著重要作用，但它們可能無法立即獲得或對每個人都有效。

Antivirals. Meanwhile, offer a critical line of defense by treating infections in real time and reducing the severity and spread of illness.

抗病毒藥物。同時，透過即時治療感染並降低疾病的嚴重程度和傳播來提供關鍵的防線。

Together, these tools provide a comprehensive approach to managing a pandemic, ensuring both preventive measures and timely treatments are available.

這些工具共同提供了管理流行病的綜合方法，確保提供預防措施和及時治療。

We anticipate working towards a new comprehensive long-term agreement spanning 5 to 10 years. As a frame of reference, our last contract executed in '2018 was valued at $546 million.

我們預計將努力達成一項為期 5 至 10 年的新的全面長期協議。作為參考，我們 2018 年執行的上一份合約價值 5.46 億美元。

Given the many changes anticipated to take place over the coming weeks in the federal government, the exact timing of the necessary steps remains to be determined.

鑑於聯邦政府預計在未來幾週內將發生許多變化，必要措施的確切時間仍有待確定。

Please keep in mind that health security is a bipartisan issue with strong alignment across both parties and transcends elections and political considerations.

請記住，衛生安全是一個兩黨共同關心的問題，兩黨之間有著強烈的一致性，超越了選舉和政治考量。

This has been reinforced by our experience with administrations from both parties.

我們與雙方政府的合作經驗進一步強化了這一點。

In fact, our last two contracts were awarded under different administrations specifically President Obama and President Trump.

事實上，我們的最後兩份合約是由不同的政府授予的，特別是歐巴馬總統和川普總統。

In summary, we're targeting the issuance of a new SNS contract in '2025 which we expect would include initial order and under such contract.

總之，我們的目標是在 2025 年發布新的 SNS 合同，我們預計其中將包括初始訂單並根據該合約。

Such a contract would further our shared goal of protecting public health through continued partnership with the U.S. government. Shifting gears, I'm pleased to share that we recently announced an exclusive license to the portfolio of our pre-clinical fully human monoclonal antibodies from the Vanderbilt University that has the potential to treat a broad range of orthopoxviruses including smallpox and mpox.

這樣的合約將進一步推動我們透過與美國政府持續合作來保護公眾健康的共同目標。換個話題，我很高興地告訴大家，我們最近宣布獲得范德比爾特大學臨床前全人單株抗體組合的獨家許可，該抗體有潛力治療多種正痘病毒，包括天花和MPOX。

This portfolio of monoclonals expands our pipeline complements our TPOXX franchise and offers the potential for development of additional therapies in this space.

此單株藥物組合擴大了我們的產品線，補充了我們的 TPOXX 特許經營權，並為該領域開發其他療法提供了潛力。

Further, it opens the door to new long term growth opportunities in collaboration with government partners to offset development investments.

此外，它還為與政府合作夥伴合作抵消發展投資打開了新的長期成長機會之門。

The U.S. Department of Defense is currently funding the development of these monoclonals through Phase 1 by a third-party contract manufacturing organization with proven expertise in biologics development and manufacturing.

美國國防部目前正在資助這些單株抗體的第一階段開發，由第三方合約製造組織在生物製劑開發和製造方面擁有成熟的專業知識。

Assuming the data are positive on these future studies we plan to explore collaborations with government stakeholders and with their input, pursue the development of these monoclonals to meet the needs of patients and public health.

假設這些未來研究的數據是正面的，我們計劃探索與政府利害關係人的合作，並根據他們的意見，開發這些單株抗體，以滿足患者和公共衛生的需求。

Our efforts will strive to develop this portfolio over the next several years efficiently without requiring significant use of the company's cash resources to progress.

我們將努力在未來幾年內有效地開發該投資組合，而無需大量使用公司的現金資源來取得進展。

The license marks an important step forward in our strategy to leverage our existing capabilities to create new opportunities for growth over the long term.

該許可證標誌著我們利用現有能力創造新的長期成長機會的策略向前邁出了重要一步。

Regarding the TPOXX post exposure prophylaxis program for smallpox or PEP, we continue to collaborate with the CDC in consultation with the FDA to complete the analysis of samples collected to support the studies immunogenicity objective.

關於天花或 PEP 的 TPOXX 暴露後預防計劃，我們繼續與 CDC 合作，並與 FDA 協商，完成對收集的樣本的分析，以支持研究的免疫原性目標。

The CDC recently began gearing up to perform the re-analysis and is targeted to complete its work in the first half of '2025. As such, we are planning for the an FDA submission of the PEP indication in the third quarter of '2025.

CDC 最近開始準備進行重新分析，目標是在 2025 年上半年完成工作。因此，我們計劃在 2025 年第三季向 FDA 提交 PEP 適應症。

As we announced on August 15, the National Institute of Allergy and Infectious Diseases or NIAID shared top line results from a preliminary analysis from the palm 007 trial.

正如我們在 8 月 15 日宣布的那樣，美國國家過敏和傳染病研究所 (NIAID) 分享了 palm 007 試驗初步分析的主要結果。

While the study denied its primary endpoint of a statistically significant improvement in time to lesion resolution within 28 days for mpox patients in the Democratic Republic of Congo who were treated with tecovirimat versus placebo. The results for this trial was not surprising due to the humanitarian considerations of the study design.

儘管該研究否認了其主要終點，即剛果民主共和國的 MPOX 患者與安慰劑相比，接受 tecovirimat 治療後 28 天內病變消退時間有統計學顯著改善。由於研究設計的人道主義考慮，這項試驗的結果並不令人意外。

Nonetheless, we are encouraged by the data showing tecovirimat's potential benefit in two important patient groups. First, those patients treated early and second, those with severe disease. We believe additional trials are warranted to explore the potential benefits of TPOXX as an mpox treatment in these and possibly other patient populations.

儘管如此，我們對顯示 tecovirat 對兩個重要患者群體的潛在益處的數據感到鼓舞。首先，那些早期接受治療的患者，其次，那些病情嚴重的患者。我們認為有必要進行更多試驗來探索 TPOXX 作為 MPOX 治療方法對這些患者群體以及其他可能的患者群體的潛在益處。

Several additional impact studies are currently being conducted by trial sponsors around the world and are expected to help inform a deeper understanding of the potential of tecovirimat to prevent benefit impact patients.

世界各地的試驗申辦者目前正在進行幾項額外的影響研究，預計將有助於更深入地了解 tecovirimat 預防受益影響患者的潛力。

Store trials are currently enrolling patients including STOMP, UNITY, PLATINUM-CANAD and EPOXY. The largest of these is STOMP sponsored by NIAID and is enrolling patients primarily in the U.S. and South America. It's progressing well with about 670 patients enrolled as of the first week of October, up from 515 reported in our last call.

商店試驗目前正在招募 STOMP、UNITY、PLATINUM-CANAD 和 EPOXY 等患者。其中最大的是由 NIAID 贊助的 STOMP，主要在美國和南美洲招募患者。進展順利，截至 10 月第一周，已有約 670 名患者入組，高於我們上次電話會議報告的 515 名患者。

I would highlight that TPOXX has demonstrated a strong safety profile and is well tolerated by patients.

我要強調的是，TPOXX 已表現出強大的安全性，且病患耐受性良好。

This is supported by preclinical safety and toxicology studies and numerous animal models including mpox infected, nonhuman primates. Phase 3, clinical data with healthy volunteers and clinical observations in disease patients.

這得到了臨床前安全性和毒理學研究以及眾多動物模型（包括MPOX感染的非人靈長類動物）的支持。第三階段，健康志願者的臨床數據和疾病患者的臨床觀察。

Additionally, more than 2000 mpox patients have participated in clinical trials to access the efficacy of TPOXX for mpox treatment. And more than 8,000 patients have been admitted TPOXX for compassionate use as the preferred antiviral to treat mpox disease.

此外，已有超過2000名mpox患者參與了臨床試驗，以了解TPOXX治療mpox的功效。已有超過 8,000 名患者因同情使用 TPOXX 作為治療 MPOX 疾病的首選抗病毒藥物而入院。

Furthermore, TPOXX has demonstrated effectiveness as an antiviral and pet treatment for survival and reduction of body lesions and viral load in nonhuman primates infected with lethal amounts of mpox virus.

此外，TPOXX 已證明作為抗病毒和寵物治療方法對於感染致命量的 MPOX 病毒的非人類靈長類動物的生存和減少身體損傷和病毒量是有效的。

Additionally, TPOXX has been shown to improve survival and reduce lesions in nonhuman primates infected with smallpox.

此外，TPOXX 已被證明可以提高感染天花的非人靈長類動物的存活率並減少病變。

Based on the totality of the scientific evidence, we believe this diverse and expansive collection of data sources highlights why TPOXX has received regulatory approval for smallpox in the U.S. and Canada and regulatory approval in the EU and the UK for a broad orthopox label including smallpox and mpox.

基於科學證據的整體性，我們相信這種多樣化和廣泛的資料來源收集突顯了為什麼TPOXX 已獲得美國和加拿大監管機構對天花的批准，以及歐盟和英國監管機構對廣泛正痘標籤（包括天花和天花）的批准。

In Japan we are actively engaged in discussions with our partner Japan Biotechno Pharma and regulators regarding the pending new drug application for TPOXX to treat smallpox, mpox, cowpox and complications due to the vicinity of virus. Based on the standard review timeline we expect a final regulatory decision by early next year.

在日本，我們正在與我們的合作夥伴 Japan Biotechno Pharma 和監管機構積極討論 TPOXX 的新藥申請，用於治療天花、mpox、牛痘以及病毒附近引起的併發症。根據標準審查時間表，我們預計最終的監管決定將在明年初做出。

In summary, this is an exciting and dynamic time for SIGA. We are strong, resilient and profitable.

總而言之，對於 SIGA 來說，這是一個令人興奮且充滿活力的時刻。我們強大、有彈性、獲利能力強。

Our strategy and prudent capital management is delivering solid results, and we believe make us well positioned for the future. Additionally, our TPOXX franchise meets a critical need for smallpox preparedness. And our team has the expertise to drive long-term results which we believe will produce sustainable growth and shareholder value over time.

我們的策略和審慎的資本管理正在帶來堅實的成果，我們相信這使我們為未來做好了準備。此外，我們的 TPOXX 特許經營權滿足了天花防備的關鍵需求。我們的團隊擁有推動長期成果的專業知識，我們相信隨著時間的推移，這些成果將帶來永續成長和股東價值。

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

這樣，我會將其交給 Dan，以更詳細地審查財務結果。

Thanks Diem, as noted earlier in the call biggest product sales for the nine months ended September 30, 2024, continue to outpace product sales for the comparable period in '2023. Product revenue for the nine months ended September 30, 2024, was $53 million. Out of this amount $9 million is related to the third quarter. In the third quarter, there was an $8 million oral TPOXX delivery to the U.S. Strategic National Stockpile or SNS and a $1 million of international sales.

謝謝 Diem，正如早些時候在電話會議中指出的那樣，截至 2024 年 9 月 30 日的九個月的最大產品銷售額繼續超過 2023 年同期的產品銷售額。截至 2024 年 9 月 30 日的九個月的產品收入為 5,300 萬美元。其中 900 萬美元與第三季相關。第三季度，美國國家戰略儲備或 SNS 的口服 TPOXX 交付金額為 800 萬美元，國際銷售額為 100 萬美元。

The $8 million oral TPOXX delivery represents the first delivery to the SNS in connection with the $112.5 million order under the 19C contract, which was announced in July.

此次 800 萬美元的 TPOXX 口頭交付是 7 月宣布的 19C 合約下 1.125 億美元訂單中首次向 SNS 交付。

The international sales amount includes the first sale to Africa with respect to product revenues for the nine months ended, September 30, 2024, the $53 million amount comes from a diverse mix including $23 million of oral TPOXX sales and $17 million of IV TPOXX sales to the U.S. government under the 19C contract, $12 million of international oral TPOXX sales to 12 countries and $1 million of oral TPOXX sales to the U.S. Department of Defense.

國際銷售額包括截至2024 年9 月30 日止九個月的產品收入中向非洲的首次銷售，5,300 萬美元的金額來自多種組合，包括2,300 萬美元的口服TPOXX 銷售額和1,700 萬美元的IV TPOXX 銷售額。

In addition to product related revenues, the company also has had research and development revenues for the three and nine months ended September 30, 2024, research and development revenues were $1 million and $4million respectively.

除了產品相關收入外，截至2024年9月30日的三個月和九個月，該公司還有研發收入，研發收入分別為100萬美元和400萬美元。

Pretax operating income which excludes interest income and taxes was $0.5 million for the three months ended September 30, 2024, for the nine months ended September 30, pretax operating income was $13 million.

截至2024年9月30日的三個月，稅前營業收入（不含利息收入和稅費）為50萬美元，截至9月30日的九個月，稅前營業收入為1,300萬美元。

In comparison, there is a pretax operating loss for the three and nine months ended September 30, 2023, of $1 million and $8 million dollars respectively.

相較之下，截至 2023 年 9 月 30 日的三個月和九個月的稅前營運虧損分別為 100 萬美元和 800 萬美元。

That income for the three months to September 30, 2024, was $1 million for the nine months end of September 30th that income was $13 million in turn fully diluted income per share for the three months end, September 30, 2024, was $2.

截至2024年9月30日的三個月的收入為100萬美元，截至9月30日的九個月的收入為1300萬美元，而截至2024年9月30日的三個月的完全攤薄每股收入為2美元。

And for the nine months into September 30th fully diluted income per share was $19 at September 30, 2024. The company continued to maintain a strong balance sheet with a cash balance of $99 million and no debt.

截至 9 月 30 日的九個月，截至 2024 年 9 月 30 日的完全稀釋每股收益為 19 美元。該公司繼續保持強勁的資產負債表，現金餘額為 9,900 萬美元，無債務。

I would like to note that the company has maintained a strong balance sheet while also returning substantial cash to shareholders.

我想指出的是，該公司維持了強勁的資產負債表，同時也向股東返還了大量現金。

As a quick reminder on April 11, they could pay the cash dividend of $60 per share which amounted to a $43 million payment to shareholders.

4 月 11 日快速提醒，他們可以支付每股 60 美元的現金股息，相當於向股東支付 4,300 萬美元。

Looking forward, as I mentioned earlier in the call, we are well positioned for substantial revenues in the fourth quarter and into '2025. In light of our outstanding order, balance of $146 million as of September 30, as such, we believe '2024 is lining up to be another year of strong product revenue performance.

展望未來，正如我之前在電話會議中提到的，我們已做好準備，在第四季和 2025 年實現可觀收入。鑑於截至 9 月 30 日我們的未完成訂單餘額為 1.46 億美元，我們相信 2024 年將是產品收入表現強勁的另一年。

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

財務更新至此結束。我會把電話轉回給吳廷琰。

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

謝謝丹，我們想開始提問。

Thank you, ladies and gentlemen. (Operator Instructions)

謝謝你們，女士們、先生們。（操作員說明）

Your first question comes from Jyoti Prakash at Edison Group. Please go ahead.

你的第一個問題來自愛迪生集團的喬蒂·普拉卡什。請繼續。

Hello, thank you for taking my questions. I have around 3 to 4 questions. So let me ask them one after the other. It's great to see that the deliveries under the BARDA order for oral TPOXX have started happening in Q4. My question is related to the deliveries of IV TPOXX which seem to be more protracted in comparison to oral TPOXX.

您好，感謝您回答我的問題。我有大約 3 到 4 個問題。那就讓我一一詢問他們吧。很高興看到 BARDA 訂單下的口服 TPOXX 訂單已於第四季度開始交付。我的問題與 IV TPOXX 的給藥有關，與口服 TPOXX 相比，IV TPOXX 的給藥時間似乎更長。

What are the reasons for this? Are there any particular supply chain related constraints? When can we see orders being delivered for IV TPOXX?

其原因何在？是否有任何特定的供應鏈相關限制？我們什麼時候可以看到 IV TPOXX 的訂單交付？

And secondly, when can we expect the latest order from the Department of Defense to be delivered?

其次，我們預期國防部的最新訂單何時可以交付？

So, Jyoti thank you so much for your first question. I will start by first giving you a little context between oral TPOXX as well as the IV. Oral TPOXX is the predominant formulation of the US government stockpile and in connection with its delivery activity, the timing and the cadence of the order activity is a very, very different between the two formulations, whether it's oral or IV.

所以，喬蒂非常感謝你提出第一個問題。首先，我將先向您介紹口服 TPOXX 和 IV 之間的背景。口服 TPOXX 是美國政府庫存的主要製劑，就其交付活動而言，兩種製劑（無論是口服還是靜脈注射）的訂購活動的時間安排和節奏都非常不同。

The manufacturing process for IV is much more complex than the oral process.

IV 的製造過程比口服過程複雜得多。

For TPOXX with the use of different vendors as well as some different raw materials. Given these differences, IV and oral TPOXX are on different schedules with IV requiring longer manufacturing lead times than oral.

對於TPOXX來說，使用不同的供應商以及一些不同的原料。鑑於這些差異，靜脈注射和口服 TPOXX 的時間表不同，靜脈注射比口服需要更長的生產週期。

Lastly, product deliveries, whether it's IV or orals are partially dependent on whether customers would like to take when the customers would like to take delivery. As Dan mentioned, the timing of the orals from the last contract tranche is, has started in '2024 and will continue into '2025.

最後，產品交付，無論是靜脈注射還是口服，部分取決於客戶是否願意在客戶願意接受交付時接受。正如 Dan 所提到的，最後一份合約的口頭談判時間已於 2024 年開始，並將持續到 2025 年。

Okay. That's helpful. And just on the question on the deliveries under the Department of Defense contract.

好的。這很有幫助。關於根據國防部合約交付的問題。

I think I (Multiple Speakers), yeah, and I said that the, the deliveries have started in already this year and will continue into '2025.

我想我（多位發言者）是的，我說過，交付已於今年開始，並將持續到 2025 年。

Oh, okay. Thank you, and the second question is related to your internationalization efforts. It's great to see you make your commercial foray into Africa. Just want to understand since your Amendment agreement of the amendment with Meridian how, what kind of traction, opportunity or challenges are you seeing in the international markets?

哦好的。謝謝，第二個問題是關於你們國際化的努力。很高興看到您進軍非洲進行商業投資。只是想了解自從您與 Meridian 達成修訂協議以來，您在國際市場上看到了什麼樣的吸引力、機會或挑戰？

So, thank you. Aas a gentle reminder for the broad audience, we amended the Meridian Agreement effective in June 1, so that we could bring all the international marketing sales in house except for a few administrative and supportive activities provided by Meridian. This change has given us greater control to meet the needs of our global customers. Since amending the agreement, we've been spending considerable time strengthening and building our relationships with current and as well as potential customers around the globe.

所以，謝謝你。謹向廣大受眾溫馨提醒，我們修訂了 Meridian 協議，並於 6 月 1 日生效，這樣我們就可以將所有國際行銷銷售納入內部，除了 Meridian 提供的一些管理和支援活動之外。這項變更使我們能夠更好地控制以滿足全球客戶的需求。自從修改協議以來，我們花費了大量時間來加強和建立與全球現有和潛在客戶的關係。

And we're all centered around the expanding of our international business with the recent sale of Africa to the request of the Ministry of Health in Morocco we believe our effort is off to a great start. Bringing the effort in house has definitely enhanced our (inaudible) dialogue with international customers and we expect it will help our ongoing efforts to pursue sales opportunities over the immediate and long-term horizon. We have not experienced any challenges at this point in this transition.

我們都以擴大我們的國際業務為中心，最近應摩洛哥衛生部的要求出售了非洲，我們相信我們的努力有了一個好的開始。內部的努力無疑增強了我們與國際客戶（聽不清楚）的對話，我們希望這將有助於我們不斷努力在近期和長期範圍內尋求銷售機會。在這個過渡過程中，我們目前尚未遇到任何挑戰。

Perfect. And moving on. It, it's great to see that you've been licensed to new pre-clinical program. Can you provide us some more details on the deal economics? And when can we expect this program to enter clinical studies? And how do you plan to develop this as a monotherapy or a combination therapy with TPOXX?

完美的。並繼續前進。很高興看到您已獲得新的臨床前計畫的許可。您能否向我們提供更多有關交易經濟學的細節？我們預計這個計畫什麼時候可以進入臨床研究？您打算如何將其開發為單一療法或與 TPOXX 的聯合療法？

Sure. Thank you for asking. We're extremely excited about the recent in license of the monoclonal antibody portfolio from Vanderbilt. And we're excited about this opportunity to expand our pipeline and strengthen our ability to be in the orthopox space. These antibodies, we believe have a potential to treat a broad spectrum of orthopox viruses which is inclusive of smallpox and mpox. And we would look to develop them from a therapeutic as well as a prophylactic consideration.

當然。謝謝你的詢問。我們對范德比爾特最近獲得的單株抗體組合許可感到非常興奮。我們很高興有機會擴大我們的產品線並增強我們在正痘領域的能力。我們相信這些抗體具有治療廣譜正痘病毒的潛力，其中包括天花和MPOX。我們希望從治療和預防的角度來發展它們。

We've demonstrated promise in preclinical models and could potentially use as a stand-alone treatment or in the combination with TPOXX and given our capabilities in clinical development as well as partnerships in the U.S. government agencies. We believe we're best suited to maximize the potential of these therapies in a cost-effective manner.

鑑於我們在臨床開發方面的能力以及與美國政府機構的合作關係，我們已經在臨床前模型中展示了前景，並且有可能用作獨立治療或與 TPOXX 聯合使用。我們相信我們最適合以具成本效益的方式最大限度地發揮這些療法的潛力。

In fact, the DoD has recently funded the development through a third party with monoclonal antibody manufacturer expertise. There is phase one as we work through the clinical development process, we will keep you posted. It's premature to talk about timing.

事實上，國防部最近透過具有單株抗體製造商專業知識的第三方資助了該開發。我們在臨床開發過程中存在第一階段，我們會及時通知您。現在談論時機還為時過早。

Excellent. And I have one final question. There have been recent media reports on some mpox patients being resistant to TPOXX can you provide your perspective on these reports? And if, if that's a concern for SIGA.

出色的。我還有最後一個問題。最近有媒體通報一些mpox患者對TPOXX產生抗藥性，您能否對這些報導發表您的看法？如果，如果這是 SIGA 關心的問題。

Thank you for giving us an opportunity to weigh in on some of these reports as it relates to resistance. I always think it's important to think about considerations based on totality of data I will first start with by saying that the pre-clinical evidence collected to date has shown no resistance to in animals treated with TPOXX for an extended time frame.

感謝您給我們機會對其中一些與阻力相關的報告進行評估。我始終認為，基於全部數據進行考慮是很重要的，我首先會說，迄今為止收集的臨床前證據表明，在較長時間範圍內接受 TPOXX 治療的動物沒有抗藥性。

Additionally, CDC reports document only a small number of drug resistant developing in patients receiving TPOXX. Overall, it remains low at less than 1% in the patient population.

此外，CDC 報告僅記錄了少數接受 TPOXX 治療的患者出現抗藥性。總體而言，該比例在患者群體中仍然很低，不到 1%。

This resistance has been primarily observed in a limited number of immunocompromised patients or those with advanced HIV who have received extended courses of treatment beyond the recommended duration.

這種抗藥性主要在少數免疫功能低下的患者或接受超過建議療程的延長療程的晚期愛滋病毒患者中觀察到。

I think the recent report you're referring to is the October CDC morbidity and mortality weekly report.

我認為您所指的最近報告是 10 月疾病預防控制中心發病率和死亡率週報告。

This is noted a small sample of patients with mild mpox, resistance to TPOXX was reported in a few patients.

值得注意的是，在少數患有輕度 MPOX 的患者樣本中，少數患者報告了對 TPOXX 的抗藥性。

This finding is potentially important and does warrant further investigation to guide future treatment protocols. However, I think it's important to note that the treatment history, documentation was not collected to better understand these reports.

這項發現可能很重要，確實值得進一步研究以指導未來的治療方案。然而，我認為重要的是要注意，沒有收集治療史和文件來更好地理解這些報告。

And additionally, these reports omit important data related to the total number of specimens tested patient profiles as well as treatment timing, making it difficult to reach a conclusion about tecovirimat's efficacy and mpox's treatment or overall detection of drug resistance.

此外，這些報告忽略了與測試的樣本總數、患者概況以及治療時機相關的重要數據，使得很難就 tecovirimat 的療效和 MPOX 的治療或總體抗藥性檢測得出結論。

It's really important to note that the resistance of smallpox or mpox is less likely to occur compared to COVID-19 or Influenza.

值得注意的是，與 COVID-19 或流感相比，天花或 MPOX 產生抗藥性的可能性較小。

For example, smallpox and mpox are DNA viruses which mutate less easily than RNA viruses like the viruses that I just mentioned, COVID and Influenza. This may attribute it to the low levels of resistance observed to date with tecovirimat.

例如，天花和mpox是DNA病毒，它們比RNA病毒（例如我剛才提到的新冠病毒和流感病毒）更不容易突變。這可能歸因於迄今為止觀察到的替科維馬的低水平抗藥性。

I would like to remind everyone that there is no demonstrated tecovirimat resistance to smallpox and we have not identified that to date.

我想提醒大家，沒有證據顯示替科維馬對天花有抵抗力，而且到目前為止我們還沒有確定這一點。

Thank you. That's very helpful. That's all the questions I have. Congratulations on the quarter.

謝謝。這非常有幫助。這就是我的所有問題。恭喜本季。

Thank you. (Multiple Speakers)

謝謝。（多位發言者）

Thank you, ladies and gentlemen. (Operator Instructions)

謝謝你們，女士們、先生們。（操作員說明）

It appears we have no further questions. I will turn the call back over for closing comments.

看來我們沒有其他問題了。我將把電話轉回以徵求結束意見。

Thank you. Thank you so much for dialing in to SIGA's call and for your ongoing interest in our company. We look forward to speaking to you again on our fourth quarter call. Have a good rest of the evening.

謝謝。非常感謝您撥打 SIGA 的電話以及您對我們公司的持續關注。我們期待在第四季度的電話會議上再次與您交談。晚上好好休息。

Ladies and gentlemen, this concludes your conference for today. We thank you for participating. (Operator Instructions)

女士們、先生們，今天的會議到此結束。我們感謝您的參與。 （操作員說明）