BNB Plus Corp (BNBX) 2024 Q1 法說會逐字稿

Good day, and welcome to the Applied DNA Sciences fiscal first-quarter 2024 financial results conference call. (Operator Instructions) Please note this event is being recorded.

美好的一天，歡迎參加應用 DNA 科學 2024 年第一季財務業績電話會議。（操作員說明）請注意此事件正在被記錄。

I would now like to turn the conference over to Sanjay Hurry, Head of Investor Relations. Please go ahead.

我現在想將會議交給投資者關係主管桑傑·赫里 (Sanjay Hurry)。請繼續。

Thank you, Scott. Good afternoon, everyone, and welcome to Applied DNA's conference call to discuss our first-quarter fiscal 2024 financial results. You may access the press release that was issued after market close today as well as a slide presentation accompanying this call on the Investor Relations section of our corporate website. Speaking on the call today are Dr. James Hayward, our Chairman, President, and CEO; and Beth Jantzen, our Chief Financial Officer. Clary Shorrock, Chief Legal Officer and Head of Business Development; Judy Murrah, our Chief Operating Officer, will also be available to answer questions on the Q&A portion of this call.

謝謝你，斯科特。大家下午好，歡迎參加 Applied DNA 的電話會議，討論我們 2024 財年第一季的財務表現。您可以在我們公司網站的投資者關係部分訪問今天收盤後發布的新聞稿以及本次電話會議附帶的幻燈片演示。今天在電話會議上發言的是我們的董事長、總裁兼執行長 James Hayward 博士；以及我們的財務長 Beth Jantzen。Clary Shorrock，首席法務官兼業務發展主管；我們的營運長 Judy Murrah 也將回答本次電話會議問答部分的問題。

Before we get started, I would like to take this opportunity to remind you that our remarks today may include forward-looking statements. I refer you to slide 2 of the presentation and our Form 10-Q filed a short while ago for important risk factors that could cause the company's actual performance and results to differ materially from those expressed or implied in any forward-looking statements. We undertake no obligation to update or revise any forward-looking statements for other information provided on this call. As a result of new information, our future results are developed.

在我們開始之前，我想藉此機會提醒您，我們今天的言論可能包含前瞻性陳述。我建議您參閱簡報的投影片 2 和我們不久前提交的 10-Q 表格，以了解可能導致本公司的實際業績和結果與任何前瞻性陳述中明示或暗示的內容有重大差異的重要風險因素。我們不承擔更新或修改本次電話會議中提供的其他資訊的任何前瞻性陳述的義務。新資訊的結果是我們未來的結果。

Now, it's my pleasure to introduce our first speaker on today's call, Beth Jantzen. Please go ahead, Beth.

現在，我很高興介紹今天電話會議的第一位發言人 Beth Jantzen。請繼續，貝絲。

Thank you, Sanjay. Good afternoon, everyone. Thank you for joining us on our first-quarter fiscal 2024 investor call. I will start this afternoon with an overview of our results for the quarter ended December 31, 2023. I will then turn the call over to Dr. James Hayward, our President and CEO, who will update you on our ongoing business initiatives. We will then open the line for questions from our analysts and institutional investors.

謝謝你，桑傑。大家下午好。感謝您參加我們的 2024 財年第一季投資者電話會議。我將從今天下午開始概述我們截至 2023 年 12 月 31 日的季度業績。然後，我會將電話轉給我們的總裁兼執行長詹姆斯·海沃德 (James Hayward) 博士，他將向您介紹我們正在進行的業務計劃的最新情況。然後，我們將開通分析師和機構投資者提問熱線。

Beginning with our statement of operations, total revenue for the first quarter of fiscal 2024 ended December 31, 2023, for approximately $891,000, or a decline of $4.4 million compared to $5.3 million for the same period in the prior-fiscal year. Approximately $4.2 million of this decrease in total revenue is attributable to lower clinical laboratory service revenues. This revenue line item reflects an ongoing and unfavorable year-over-year comparison in our COVID-19 testing as the prior-year period included testing revenues under our contracts with CUNY that expires in June of 2023.

從我們的營運報表開始，截至 2023 年 12 月 31 日的 2024 財年第一季總收入約為 891,000 美元，比上一財年同期的 530 萬美元減少了 440 萬美元。總收入減少約 420 萬美元是由於臨床實驗室服務收入減少所致。此收入項目反映了我們的 COVID-19 測試中持續且不利的同比比較，因為去年同期包括根據我們與 CUNY 於 2023 年 6 月到期的合約進行的測試收入。

Approximately $210,000 of the decrease in total revenue was attributable to lower product revenues and specifically lower cotton DNA tagging revenue within our DNA Tagging and Security Product and Services segment. Service revenues increased approximately $15,000 year over year and approximately $78,000 sequentially that were driven primarily by demand for isotopic testing within our DNA Tagging and Security Products and Services segments. Gross profit was $231,000, or 26%, compared to $2.4 million, or 45%, in the prior fiscal-year period. The decline in gross margin was primarily due to a higher percentage of COVID-19 testing service revenue in the three months ended December 31, 2022, which generated a higher gross profit compared to the three months ended December 31, 2023.

總收入減少約 21 萬美元，歸因於產品收入下降，特別是 DNA 標籤和安全產品及服務部門中棉花 DNA 標籤收入的下降。服務收入年增約 15,000 美元，環比增長約 78,000 美元，這主要是由 DNA 標籤和安全產品及服務領域對同位素測試的需求所推動的。毛利為 231,000 美元，即 26%，而上一財年期間的毛利為 240 萬美元，即 45%。毛利率下降的主要原因是截至2022年12月31日止三個月的COVID-19檢測服務收入所佔比例較高，與截至2023年12月31日止三個月相比產生了更高的毛利潤。

To a lesser extent, the decline in gross profit percentage was due to lower product revenues during the three-month period ending December 31, 2023, as compared to the same period in the prior-fiscal year. The lower volume of product revenues in the current period was not able to fully absorb the fixed costs that are included in cost of product revenue.

在較小程度上，毛利率下降是由於截至 2023 年 12 月 31 日的三個月期間產品收入較上一財年同期下降。本期較低的產品收入量無法完全消化計入產品收入成本的固定成本。

Total operating expenses increased by $424,000 to $4 million compared to $3.6 million in the prior fiscal-year period. This increase in total operating expenses reflects higher SG&A costs as the prior three-month period has a credit in bad debt expense of approximately $290,000 from a customer balance that was written off and was subsequently collected during the three-month period ended December 31, 2022. The remainder of the increase is related to an increase in stock-based compensation expense of $247,000 that relates to the timing of the annual non-employee Board of Director grants that vest one year from the date of grant. These increases were offset by a decrease in payroll of approximately $107,000. Operating loss for the first quarter was $3.8 million compared to $1.2 million in the prior-fiscal period.

總營運支出增加了 424,000 美元，達到 400 萬美元，而上一財年期間的營運支出為 360 萬美元。總營運費用的增加反映了銷售、管理和行政費用的增加，因為前三個月期間從客戶餘額中貸記了約29 萬美元的壞帳費用，該客戶餘額已被註銷並隨後在截至2022 年12 月31 日的三個月期間收回。增加的其餘部分與股票薪酬費用增加 247,000 美元有關，該費用與年度非員工董事會補助金的時間有關，該補助金自授予日起一年內歸屬。這些增長被工資減少約 107,000 美元所抵消。第一季營運虧損為 380 萬美元，上一財年營運虧損為 120 萬美元。

Turning to slide 5, excluding noncash expenses, adjusted EBITDA deteriorated by $2.1 million to a negative $3.2 million compared to a negative $1.1 million in the prior fiscal-year period.

轉向投影片 5，不包括非現金支出，調整後 EBITDA 惡化 210 萬美元，降至負 320 萬美元，而上一財年期間為負 110 萬美元。

Now, turning to our balance sheet on slide 6. Accounts receivable stood at $451,000 at December 31 with payment terms ranging from 30 to 60 days, and cash and cash equivalents totaled $3.4 million on December 31 compared to $7.2 million on September 30, 2023. Fiscal year to date, our average monthly cash burn was $1.3 million compared to $780,000 in the prior-fiscal year.

現在，轉向投影片 6 上的資產負債表。截至 12 月 31 日，應收帳款為 451,000 美元，付款期限為 30 至 60 天；截至 12 月 31 日，現金及現金等價物總額為 340 萬美元，而 2023 年 9 月 30 日為 720 萬美元。財年迄今，我們平均每月現金消耗為 130 萬美元，而上一財年為 78 萬美元。

Staying with the balance sheet a moment longer, we closed on a registered direct public offering on February 2, 2024, for gross proceeds of approximately $3.4 million. Full details of the offering are provided in the subsequent events section of our Form 10-Q filing. We issued approximately $3.2 million shares and pre-funded warrants to purchase up to 2.4 million shares of common stock in a concurrent private placement unregistered common warrants to purchase up to 11.3 million shares of common stock were issued with an exercise price of $0.609 per warrant share. These common warrants are subject to shareholder approval at a stockholder meeting that must be held by April 15 of this year in accordance with the terms of the private placement.

再看一下資產負債表，我們於 2024 年 2 月 2 日完成了註冊直接公開發行，總收益約為 340 萬美元。我們的 10-Q 表格文件的後續活動部分提供了此次發行的完整詳細資訊。我們發行了約320 萬美元的股票和預先融資認股權證，以在同時私募中購買最多240 萬股普通股發行了用於購買最多1130 萬股普通股的未註冊普通認股權證，行使價為每股認股權證0.609 美元。根據私募條款，這些普通認股權證須在今年 4 月 15 日之前召開的股東大會上獲得股東批准。

Subject to approval by stockholders at a stockholder meeting, the exercise price of these warrants could result in additional gross proceeds of $6.9 million to the company. We also agreed to reduce the exercise price of warrants previously issued to the purchasers with exercise prices ranging from $1.29 to $4 per warrant to $0.609 per warrant. We also agreed to extend the expiration date of these warrants to August 2028. These warrant reductions are also subject to stockholder approval.

經股東在股東大會上批准，這些認股權證的行使價可能會為公司帶來 690 萬美元的額外總收益。我們也同意將先前發行給購買者的認股權證的行使價格降低，行使價格從每份認股權證 1.29 美元至 4 美元至每份認股權證 0.609 美元。我們也同意將這些認股權證的到期日延長至 2028 年 8 月。這些認股權證的減少還需獲得股東的批准。

Subject to approval, the exercise of the warrants issue discussed above, as well as the now-reduced warrants, could result in total gross proceeds of up to $8.6 million to the company.

如果獲得批准，上述認股權證發行以及現已減少的認股權證的行使可能會為公司帶來高達 860 萬美元的總收益。

Turning to our at-the-market facility, the ATM was terminated in accordance with the terms of and to facilitate this registered direct offering. Inclusive of the proceeds from the registered direct, cash and cash equivalents was approximately $5.1 million on February 2.

談到我們的市場設施，ATM 已根據 條款終止，並促進本次註冊直接發行。截至 2 月 2 日，包括直接註冊收益在內的現金和現金等價物約為 510 萬美元。

Before turning the call over to Jim, the commercialization of our Linea IVT and Linea DNA platforms remains our primary objective. To that end, we are committed to capital allocation that support our biotherapeutic goals while identifying and undertaking operating efficiencies throughout the company. Initial steps are being taken to manage a leaner organization aligned behind our highest ROI opportunities.

在將電話轉交給 Jim 之前，我們的 Linea IVT 和 Linea DNA 平台的商業化仍然是我們的首要目標。為此，我們致力於支持我們的生物治療目標的資本配置，同時確定並提高整個公司的營運效率。我們正在採取初步措施來管理一個更精簡的組織，以支持我們最高的投資報酬率機會。

This concludes my prepared remarks. Thank you for joining us today. I will now turn the call over to Jim for his comments.

我準備好的發言到此結束。感謝您今天加入我們。我現在將把電話轉給吉姆徵求意見。

Well, thank you, Beth. Good afternoon, everyone. Thank you for joining us on today's call. It was an important quarter for our biotherapeutic goals. This afternoon, my remarks will update you on the progress we've made during the quarter to advance the commercialization of our Linea IVT platform and establish a GMP capacity to manufacture critical starting materials for clinical-grade messenger RNA therapeutics.

嗯，謝謝你，貝絲。大家下午好。感謝您參加今天的電話會議。對於我們的生物治療目標來說，這是一個重要的季度。今天下午，我將向您介紹本季度我們在推進 Linea IVT 平台商業化以及建立 GMP 能力以生產臨床級信使 RNA 療法關鍵原材料方面所取得的進展。

Just to set the ground rules, IVT stands for in vitro transcription. In vitro means that it is performed outside of the body, and transcription is the process by which the sequence in template DNA, such as our Linea DNA templates, is turned into the sequence of messenger RNA via RNA polymerase.

為了設定基本規則，IVT 代表體外轉錄。體外是指在體外進行，轉錄是模板DNA（例如我們的Linea DNA模板）中的序列透過RNA聚合酶轉化為信使RNA序列的過程。

Our Linea IVT platform is comprised of both our Linea DNA IVT templates and our proprietary RNA polymerase ready for use in in vitro transcription of an mRNA drug. I will also share some representative customer profiles and their intended use cases for our Linea DNA and Lineage IVT platforms. These customers and their future needs for our mRNA starting materials form the basis for Applied DNA strategic growth.

我們的 Linea IVT 平台由我們的 Linea DNA IVT 模板和我們專有的 RNA 聚合酶組成，可用於 mRNA 藥物的體外轉錄。我還將分享一些具有代表性的客戶資料以及他們對我們的 Linea DNA 和 Lineage IVT 平台的預期用例。這些客戶及其未來對我們 mRNA 起始材料的需求構成了 Applied DNA 策略成長的基礎。

We are not yet at a point where we can divulge their names. However, the applications being contemplated underscore the potential and long-term need for Linea IVT. Establishing a first-phase GMP capacity to deliver messenger RNA-critical starting materials under applicable GMP and at large scale is crucial to our ability to mature our current research and development scale customers into long-term supply agreements for Linea IVT. And as you can see in this slide, in fiscal 2023, which was year one of our Lineage IVT commercialization plan.

我們還不能透露他們的名字。然而，正在考慮的應用強調了 Linea IVT 的潛在和長期需求。建立第一階段 GMP 能力，在適用的 GMP 下大規模提供信使 RNA 關鍵原料，對於我們使目前研發規模客戶成熟並達成 Linea IVT 長期供應協議的能力至關重要。正如您在這張投影片中所看到的，2023 財年是我們 Lineage IVT 商業化計畫的第一年。

We firstly launched Lineage IVT as a platform for the manufacture of mRNA. Secondly, we expanded our presence across the global marketplace. And thirdly, we grew a robust sales pipeline of marquee customers and initiated proof-of-concept studies. These efforts were supported by the establishment of the GMP roadmap to transition our manufacturing capacity from research-use only milligram scale DNA template orders to multi grounds scale, GMP orders capable of supporting our customers' early-stage toxicology, pharmacokinetics, and clinical trials.

我們首先推出了 Lineage IVT 作為 mRNA 製造的平台。其次，我們擴大了在全球市場的影響力。第三，我們發展了強大的大客戶銷售管道，並啟動了概念驗證研究。這些努力得到了GMP 路線圖的支持，將我們的生產能力從僅用於研究用途的毫克級DNA 模板訂單轉變為多場地規模、能夠支持客戶早期毒理學、藥物動力學和臨床試驗的GMP 訂單。

In year two, our current fiscal year, we are focused on migrating our customers to scale up agreements for Lineage IVT templates, coupled with our Linea RNA polymerase manufactured under applicable GMPs to support their clinical RNA objectives. With approximately 425 messenger RNA therapies currently in development and judging from our slate of meetings at the JPMorgan Healthcare Conference last month, it is evident that the biotherapeutics industry is beginning a surge in mRNA demand.

在第二年，也就是我們目前的財年，我們的重點是讓我們的客戶擴大 Lineage IVT 模板的協議，再加上我們根據適用的 GMP 生產的 Linea RNA 聚合酶，以支持他們的臨床 RNA 目標。目前大約有 425 種信使 RNA 療法正在開發中，從我們上個月在摩根大通醫療保健會議上舉行的一系列會議來看，生物治療行業顯然開始出現 mRNA 需求激增的情況。

Consequently, after the first quarter's end, we closed on the equity offering that will fund us through implementing our initial GMP footprint. As indicated on the slide, we reiterate the timing of this facility to come online is during the first half of calendar 2024.

因此，在第一季結束後，我們完成了股票發行，這將為我們實施最初的 GMP 足跡提供資金。如幻燈片所示，我們重申該設施的上線時間是 2024 年上半年。

Now, establishing a GMP footprint takes a phased approach to simultaneously support existing and new customers through their clinical trial process. Our unique business model, in which I remind you, Linea IVT is comprise the Linea IVT template, paired with our high-value RNA polymerase, allows us to drive substantial revenue from a very small space.

現在，建立 GMP 足跡需要採取分階段的方法，透過臨床試驗過程同時支援現有和新客戶。我提醒您，我們獨特的商業模式，Linea IVT 由 Linea IVT 模板與我們的高價值 RNA 聚合酶相結合，使我們能夠從很小的空間中獲得可觀的收入。

We project that this first-phase capacity will enable an annual revenue capacity of up to $15 million from a footprint of less than 1,000 square feet. Incremental capacity, we'll be straightforward to add. It is important to note that this annual figure does not serve as financial guidance. Instead, this figure is informed by internal modeling, utilizing current pricing projections and industry figures. And based on the combined sales of Linea DNA IVT templates, Linea RNA polymerase, and a royalty for a technology license.

我們預計，第一階段的產能將在不到 1,000 平方英尺的佔地面積內實現高達 1500 萬美元的年收入。增量容量，我們將直接新增。值得注意的是，該年度數據並非作為財務指引。相反，該數字是透過內部模型利用當前的定價預測和行業數據得出的。並基於 Linea DNA IVT 模板、Linea RNA 聚合酶的合併銷售額以及技術許可的版稅。

With 67% of that mRNA development pipeline in preclinical development, the industry is quickly progressing to clinical and eventually commercial stages. In year three or 2025, we believe that the economics of our unique business model will be fully realized as we initiate large scale of GMP supply to customers as they advance in the clinic and prepare for commercial launch.

67% 的 mRNA 開發管道處於臨床前開發階段，該產業正迅速進入臨床階段並最終進入商業階段。在第三年或 2025 年，我們相信，隨著客戶在臨床上的進展並為商業啟動做好準備，我們將向客戶大規模提供 GMP 供應，我們獨特的商業模式的經濟效益將得到充分實現。

Now, turning to our customers. Our sales pipeline is populated both by cutting-edge biotech companies who manufacture their own products and by CDMOs, which are contract development and manufacturing organizations, that are operating as suppliers to biotech and pharma companies. Each of these segments represents an outcome that could materially and positively alter Applied DNA's biotherapeutic profile once successfully engaged.

現在，轉向我們的客戶。我們的銷售管道既有製造自己產品的尖端生物技術公司，也有 CDMO（合約開發和製造組織），作為生物技術和製藥公司的供應商運作。這些部分中的每一個都代表著一種結果，一旦成功參與，就可以實質地、積極地改變 Applied DNA 的生物治療概況。

On this slide, you will find a select sampling of customers and applications relevant to Linea IVT that span mRNA vaccines against common respiratory illness to autoimmune and oncology therapies. From the application column, it should be clear that we are being evaluated for our ability to deliver on broadly relevant clinical indications.

在此投影片上，您將找到與 Linea IVT 相關的客戶和應用的精選樣本，涵蓋針對常見呼吸道疾病的 mRNA 疫苗到自體免疫和腫瘤治療。從應用欄中可以清楚看出，我們正在評估我們提供廣泛相關臨床適應症的能力。

With our GMP capacity about to come online, much of our sales and business development efforts have been focused on converting interest in Linea DNA as the IVT template material into evaluations of our Linea IVT platform with the ultimate goal of securing long-term supply agreements.

隨著我們的GMP 產能即將上線，我們的大部分銷售和業務開發工作都集中在將對作為IVT 模板材料的Linea DNA 的興趣轉化為對我們的Linea IVT 平台的評估，最終目標是獲得長期供應協議。

Momentum in our sales pipeline has continued to build, and our conversion efforts are paying off. We completed multiple successful evaluations by customers for our Linea DNA and Lineage IVT platforms during the quarter. The pace of Linea DNA customers initiating evaluations of Lineage IVT has quickened, and the size of the potential opportunities is increasing.

我們的銷售管道不斷增強，我們的轉型努力正在取得回報。本季度，我們完成了客戶對 Linea DNA 和 Lineage IVT 平台的多次成功評估。Linea DNA 客戶啟動 Lineage IVT 評估的步伐已經加快，潛在機會的規模也在增加。

We are already in several Lineage IVT platform evaluation cycles, a notable milestone, given our acquisition of Linea RNA polymerase was only six months ago. Particularly noteworthy, we recently completed an evaluation with the clinical-stage mRNA customer in which our IVT templates met or exceeded all customer quality metrics and with the manufacturing speed that exceeded all other IBT tinplate suppliers that the customer had evaluated. Based on this successful evaluation, we are now being asked to provide quotes for scale-up materials under GMP.

我們已經進入了幾個 Lineage IVT 平台評估週期，這是一個值得注意的里程碑，因為我們在六個月前才收購了 Linea RNA 聚合酶。特別值得注意的是，我們最近完成了對臨床階段 mRNA 客戶的評估，其中我們的 IVT 模板達到或超過了所有客戶品質指標，並且製造速度超過了客戶評估的所有其他 IBT 馬口鐵供應商。基於這次成功的評估，我們現在被要求提供 GMP 下放大材料的報價。

In addition, we are starting to see the seeds of our business development efforts with respect of large CDMOs begin to bear fruit with recent interest from several US-based mRNA CDMOs. Now, CDMOs have substantial, underutilized manufacturing capacity available after the decrease in demand for COVID-19 vaccines. We believe that Linea IVT provides these CDMOs with significant differentiators in the marketplace at a time when the mRNA modalities gaining preclinical momentum. We are in real-time discussions with CDMOs actively seeking a differentiated workflow to bring new mRNA customers into their underutilized manufacturing capacity.

此外，我們開始看到我們在大型 CDMO 方面的業務開發努力的種子開始結出碩果，最近幾家美國 mRNA CDMO 對此產生了興趣。現在，在 COVID-19 疫苗需求下降後，CDMO 擁有大量未充分利用的生產能力。我們相信，當 mRNA 模式獲得臨床前動力時，Linea IVT 為這些 CDMO 在市場上提供了顯著的差異化優勢。我們正在與 CDMO 進行即時討論，積極尋求差異化的工作流程，以將新的 mRNA 客戶帶入其未充分利用的生產能力。

CDMOs are showing particular interest in self-amplifying mRNA. During the first quarter, we shipped our first self-amplifying mRNA IVT template to a preclinical therapeutic manufacturer, thereby demonstrating that the Linea DNA's platform's ability to enzymatically produce the challenging and large DNA sequences needed to manufacture self-amplifying mRNA at scale. We believe this puts us at the forefront of template manufacturing for this promising and growing messenger RNA modality, that is self-amplifying RNA.

CDMO 對自我擴增 mRNA 表現出特別的興趣。在第一季度，我們將第一個自擴增mRNA IVT 模板運送給臨床前治療製造商，從而證明Linea DNA 平台能夠透過酵素生產大規模製造自擴增mRNA 所需的具有挑戰性的大型DNA序列。我們相信，這使我們處於這種有前途且不斷發展的信使 RNA 模式（即自擴增 RNA）模板製造的前沿。

We have validated Linea IVT for the small-scale manufacturer of mRNA-critical starting materials. To support customers much larger commercial aspirations with Linea IVT, we need to substantiate Linea IVT's performance at scale within a commercial manufacturing setting.

我們已針對 mRNA 關鍵起始材料的小規模製造商驗證了 Linea IVT。為了透過 Linea IVT 支持客戶更大的商業願望，我們需要在商業製造環境中大規模證實 Linea IVT 的表現。

In partnering with the CDMO, Kudo Bio, which was announced this quarter, we have entered the arena of commercial-scale manufacturing. Our first CDMO partner, Kudo, will help validate the commercial scale-up of the Lineage IVT platform. In Kudo Bio's workflow, our Linea IV T platform would serve as the front end of an integrated GMP mRNA drug product manufacturing workflow. We believe that Kudo's integration of our Linea IVT platform to simplify mRNA production and to drive double-stranded RNA mitigation gives them a substantial leg up over other CDMOs.

透過與本季宣布的 CDMO Kudo Bio 合作，我們已進入商業規模製造領域。我們的第一個 CDMO 合作夥伴 Kudo 將協助驗證 Lineage IVT 平台的商業規模擴大。在 Kudo Bio 的工作流程中，我們的 Linea IV T 平台將作為整合 GMP mRNA 藥品製造工作流程的前端。我們相信，Kudo 整合了我們的 Linea IVT 平台來簡化 mRNA 生產並推動雙股 RNA 緩解，這使他們比其他 CDMO 具有顯著優勢。

Now, during the quarter, we also entered into a scale-up manufacturing agreement with an enzyme manufacturer for Linea RNA polymerase enzyme to scale its production for commercial-scale use. This is part of our efforts to increase efficiencies and reduce Linea IVT's cost of goods sold as we move to deploy our improved workflow into cGMP capacity. In brief, we believe this project once completed, will ensure we can manufacture our Linea RNA polymerase at a scale and reduce cost of goods to enable profitable growth of Linea IVT. And we expect to announce this agreement in a press release soon.

現在，在本季度，我們還與一家酵素製造商簽訂了 Linea RNA 聚合酶的擴大生產協議，以擴大其生產規模以實現商業規模用途。這是我們提高效率和降低 Linea IVT 銷售成本的努力的一部分，因為我們正在將改進的工作流程部署到 cGMP 能力中。簡而言之，我們相信該專案一旦完成，將確保我們能夠大規模生產 Linea RNA 聚合酶並降低商品成本，從而實現 Linea IVT 的獲利成長。我們預計很快會在新聞稿中宣布這項協議。

This quarter also saw us generate new compelling data that further substantiate the capacity of our Linea IVT platform to create equal or greater RNA yields with mitigated double-stranded RNA contamination at levels that are 10 to 50 times lower than those found using conventional mRNA production technologies. Now, this is a very strong selling point to mRNA therapy developers and CDMOs today that are seeking ways to mitigate double-stranded RNA without sacrificing their mRNA production yields. We see our ability to drastically mitigate double-stranded RNA, which enables the IVT platform to produce better RNA, faster as a key differential differentiator against our competitors.

本季我們也產生了令人信服的新數據，進一步證實了我們的Linea IVT 平台能夠產生相同或更高的RNA 產量，同時減少雙股RNA 污染，其水平比使用傳統mRNA 生產技術的水平低10至50 倍。現在，對於 mRNA 療法開發商和 CDMO 來說，這是一個非常強大的賣點，他們正在尋求在不犧牲 mRNA 產量的情況下減輕雙股 RNA 的方法。我們看到我們能夠大幅減輕雙股 RNA 的影響，這使得 IVT 平台能夠更快地生產更好的 RNA，這是我們與競爭對手的關鍵差異化因素。

In a further application of Linea DNA, our partnership with the Institute of Hematology and Blood Transfusion in Prague on their CD123-CAR therapy has moved past the experimental stage. Pending finalization of the supply agreement with us, we expect the Institute of Hematology and Blood Transfusion in Prague will receive EU regulatory approval to proceed with the Phase 1 CD123 clinical trial to those 10 compassionate use patients with their CAR T therapy. The Phase 1 trial is expected to begin before the end of this calendar year. Now, this is a significant milestone for Linea DNA and its application to the rapid and efficient manufacture of CAR T cells without the need for complicated virus production or plasmid DNA. We congratulate the Institute and look forward to the results with great anticipation.

在 Linea DNA 的進一步應用中，我們與布拉格血液學和輸血研究所合作開發的 CD123-CAR 療法已經過了實驗階段。在與我們敲定供應協議之前，我們預計布拉格血液學和輸血研究所將獲得歐盟監管部門的批准，繼續對這 10 名同情使用 CAR T 療法的患者進行 CD123 1 期臨床試驗。第一階段試驗預計今年底前開始。現在，這對於 Linea DNA 及其在無需複雜的病毒生產或質粒 DNA 的情況下快速高效製造 CAR T 細胞的應用來說是一個重要的里程碑。我們對研究所表示祝賀，並滿懷期待地期待著成果。

Now, before I open our call to questions. I want to impress on our investors that we have made substantial headway in bringing a more rapid, cost-efficient, and qualitative process to creating DNA at a scale for commercial availability. We feel that the imminent establishment of our GMP footprint keeps us firmly on a growth company trajectory with positive ramifications for long term shareholder value.

現在，在我開始提問之前。我想讓我們的投資者留下深刻的印象，我們在以更快速、更具成本效益和定性的流程來大規模創造 DNA 以實現商業可用性方面取得了實質進展。我們認為，即將建立的 GMP 足跡將使我們堅定地走在成長型公司的軌道上，並對長期股東價值產生積極影響。

Now, this concludes my prepared remarks. Operator, please open the call to questions.

現在，我準備好的發言就到此結束。接線員，請打開電話提問。

(Operator Instructions) Jason McCarthy, Maxim Group.

（操作員說明）Jason McCarthy，Maxim Group。

Hi, Jim. Thanks for taking the questions . First, just on your last point there from the Prague Hematology Institute doing the CD123 CAR work, can you talk a little bit more about what they're targeting or maybe even some of their preclinical work that they had done? And since they're expecting to move from preclinical to clinical, at least in the EU on that, is that going to require GMP-grade materials from Applied?

嗨，吉姆。感謝您提出問題。首先，就布拉格血液學研究所所做的 CD123 CAR 工作的最後一點而言，您能否多談談他們的目標是什麼，甚至他們所做的一些臨床前工作？既然他們期望從臨床前轉向臨床，至少在歐盟是這樣，那麼這是否需要應用材料公司的 GMP 級材料？

Great question, Jason. First of all, I have to tell you these folks are great scientists and I delight to work with. Having done my PhD in hematology, I can I appreciate the quality of their work. So they have an entire CAR-T program laid out, and they find value in our approach to the kind of CAR T. The European authorities have indicated that they will approve and up labeling of our research use our DNA construct to cGMP at their facility. And so after an inspection here and some additional correspondence with the EMA, we expect that to happen for us with. Their animal study results were superb, and it's based on that the European authorities are taking their position that compassionate use would be apropos.

好問題，傑森。首先，我必須告訴你，這些人都是偉大的科學家，我很高興能與他們合作。在完成血液學博士學位後，我可以欣賞他們的工作品質。因此，他們制定了完整的CAR-T 計劃，並發現了我們的CAR-T 方法的價值。歐洲當局已表示，他們將批准我們的研究，並在他們的設施中使用我們的DNA 構建體進行cGMP標記。因此，在進行了檢查並與 EMA 進行了一些額外的通信之後，我們希望這種情況能夠發生在我們身上。他們的動物研究結果非常出色，這是基於歐洲當局採取的立場，即同情使用是適當的。

So what degree or what level of, or actually, rather amount of product do they need for starting material? Or I mean a clinical Phase 1 trial for CAR T, we can probably do just a handful of patients. So I'm assuming that maybe it's not that much material that you'll need?

那麼他們需要什麼程度或什麼水平，或者實際上，相當數量的產品作為起始材料？或者我的意思是 CAR T 的臨床 1 期試驗，我們可能只能對少數患者進行試驗。所以我假設您可能不需要那麼多材料？

Yeah, it's probably enough material to treat, I'd say, about 10 patients. I don't want to speak for them because the details are under their control, but that's what I'm expecting. So that should be no problem for us.

是的，我想說，這些材料可能足以治療大約 10 名患者。我不想代表他們說話，因為細節在他們的控制之下，但這就是我所期待的。所以這對我們來說應該不成問題。

Do you have -- has it publicly disclosed who the principal investigators at the Prague Hematology Institute?

您是否公開披露了布拉格血液學研究所的主要研究人員是誰？

I'm sorry. Could you try that again, Jason? The what?

對不起。你能再試一次嗎，傑森？什麼？

Is it publicly available who the principal investigator is at the Prague Institute? Just thinking if we pulled some papers, just read some of their work.

布拉格研究所的首席研究員是誰可以公開嗎？只是想如果我們拿出一些論文，讀他們的一些作品。

Oh, sure. I'd be happy to verify that it is -- then out of not only get their names for you, but I'd be happy to put you in touch with them, and you can pull all the papers as well.

哦沒問題。我很樂意驗證這一點 - 然後不僅可以為您提供他們的名字，而且我很樂意讓您與他們聯繫，您也可以提取所有文件。

Great. Then also just moving over to the Kudo Bio relationship that was updated back in December. As a CDMO in the mRNA space panel, can you give us a little bit of color on kind of maybe who they're producing for or what they're producing mRNA products for and I guess, at what scale? Are they significantly large player compared to others in this space?

偉大的。然後，我們也轉向了 12 月更新的 Kudo Bio 關係。作為 mRNA 空間小組中的 CDMO，您能否給我們一些關於他們正在為誰生產或他們正在為什麼生產 mRNA 產品的信息，我猜，規模是多少？與該領域的其他公司相比，他們是重要的參與者嗎？

They are a large player with international facilities, including in Boston. And Clay, you're on the line, correct me if I'm wrong, but I believe they also have facilities in Singapore. And their scale is quite large, so they have the opportunity to really be an end-to-end mRNA manufacturer at very significant scale.

他們是一家擁有國際設施的大型企業，包括在波士頓。克萊，你在線上，如果我錯了請糾正我，但我相信他們在新加坡也有設施。而且他們的規模相當大，因此他們有機會真正成為規模非常大的端對端mRNA製造商。

Yeah. And I can jump in there. Thanks, Jim. Yeah, so they have facilities, Jason, in the US. They also have their main manufacturing facilities in China. They're currently manufacturing clinical materials for clinical trials in China and also Australia. They're a great partner, to be frank, and they are new to the mRNA manufacturing space, but they do have the ability to scale, very large commercial scale, as Jim noted. But there's also potential additional synergies there that we are investigating.

是的。我可以跳進去。謝謝，吉姆。是的，傑森，他們在美國有設施。他們的主要製造工廠也位於中國。他們目前正在為中國和澳洲的臨床試驗生產臨床材料。坦白說，他們是一個很好的合作夥伴，而且他們是 mRNA 製造領域的新手，但正如 Jim 指出的那樣，他們確實有能力擴大規模，非常大的商業規模。但我們正在研究潛在的額外協同效應。

Are they taking on the RNF enzyme as well as part of all this work that you're doing with them?

他們是否承擔了 RNF 酶以及您與他們一起所做的所有工作的一部分？

Yeah. So under the close contact, yeah. So the joint development agreement that was disclosed, the goal of that agreement is to scale Linea IVT to commercial cap. Right now, we've proven that Linea IVT works extremely well at the small scale. We need that validation that the platform scale to [multi-liter] IVT scale, right? And that's what we are doing with them, and then we'll bring the results in mRNA through LNP encapsulation into DRO-SUP and then DRO product.

是的。所以在密切接觸下，是的。因此，所揭露的聯合開發協議的目標是將 Linea IVT 擴展到商業上限。現在，我們已經證明 Linea IVT 在小規模下運作得非常好。我們需要驗證平台可擴展到[多升] IVT 規模，對嗎？這就是我們正在對它們所做的事情，然後我們將透過 LNP 封裝將 mRNA 的結果引入 DRO-SUP，然後是 DRO 產品。

Got it. Last question. Just briefly on slide 9, you give a sample of select customers in the biotherapeutics space and kind of what they're working on. Can you tell us how many customers you do have in total? And if you're expecting any of them to potentially transition from in vitro or preclinical work to clinical this year Thank you.

知道了。最後一個問題。在投影片 9 上，您簡要介紹了生物治療領域的精選客戶樣本以及他們正在從事的工作。您能告訴我們您總共有多少客戶嗎？如果您預計其中任何一個可能會在今年從體外或臨床前工作過渡到臨床，謝謝。

Clay, you want to take that, too?

克萊，你也想拿那個嗎？

Sure, absolutely. So obviously, we can't disclose names, Jason. But since the launch of Linea IVT in August 2023, we've really seen more rapid adoption of the platform that's been driven, I would say, an equal part of the enzymatic IVT template story, but also the ability to reduce the dsRNA, right?

當然，絕對。顯然，我們不能透露姓名，傑森。但自從 2023 年 8 月推出 Linea IVT 以來，我們確實看到了該平台的更快採用，我想說，該平台不僅是酶 IVT 模板故事的重要組成部分，而且還具有減少 dsRNA 的能力，對吧？

So on our early customers, our IVT temporary customers, they are not enzyme customers since we didn't have the enzyme at the time. And we're seeing those customers come through successful evaluations, and we're getting asked for the first time to quote upon what would scale up look like, what does scale under GMP look like? And that's why we have this urgency for this (technical difficulty) note. And also therapeutic customers of the joint Linea IVT platform. And that's important because the economics of selling that enzyme along with the template are so much more advantageous for us.

所以對於我們早期的客戶，我們IVT的臨時客戶，他們不是酵素的客戶，因為我們當時沒有酵素。我們看到這些客戶通過了成功的評估，我們第一次被要求對擴大規模的情況進行報價，GMP 下的規模是什麼樣的？這就是為什麼我們對這個（技術難度）說明如此緊迫。以及聯合 Linea IVT 平台的治療客戶。這很重要，因為將酵素與模板一起銷售的經濟效益對我們來說更加有利。

So we had some first successful evaluations of that platform. The first one was actually with Kudo, and we're seeing some follow-on evaluations now, and the readouts have been fantastic. And we had a readout last week from one of our customers on the template. And as Jim noted in his prepared remarks, we actually met or exceeded all specs, and our time to manufacture it beat everyone else that they were looking at. So it's quite promising.

因此，我們對該平台進行了一些首次成功的評估。第一個實際上是與工藤一起進行的，我們現在看到了一些後續的評估，並且讀數非常好。上週我們收到了一位客戶對模板的解讀。正如吉姆在他準備好的演講中指出的那樣，我們實際上達到或超過了所有規格，而且我們製造它的時間超過了他們正在考慮的其他所有人。所以它很有前途。

Great. Thank you both.

偉大的。謝謝你們倆。

Thank you.

謝謝。

Thank you.

謝謝。

Dipesh Patel, H.C. Wainwright.

帕特爾 (Dipesh Patel)，H.C.溫賴特。

Hi, James, and thank you for the additional details there. Regarding Slide 9, just a follow-up question. Are you able to share more color on the percentage of customers that you have in the US and the ex US? And how might you expect this to trend over the coming quarters?

你好，詹姆斯，感謝您提供更多詳細資訊。關於投影片 9，只是一個後續問題。您能否分享更多有關您在美國和美國以外地區的客戶百分比的資訊？您預計未來幾季的趨勢如何？

Yeah. The bulk of our customers are US at the moment. But with a good smattering of international customers coming both from Asia and from the European Union, I expect that we'll see more from the European Union over the course of the next year or so. And while we profiled in slide 9, only six -- we have many more customers than that. And what's really compelling is that many of those customers are returning for additional orders and for orders of greater volume.

是的。目前我們的客戶大多是美國。但由於有大量來自亞洲和歐盟的國際客戶，我預計在未來一年左右的時間裡，我們將看到更多來自歐盟的客戶。雖然我們在投影片 9 中介紹了只有 6 位客戶，但我們的客戶數量遠多於此。真正引人注目的是，許多客戶正在返回購買更多訂單和更大數量的訂單。

Great. And then last question, with regards to your the projection that you noted of up to $15 million annual for the Linea IVT revenue, what assumptions can we kind of take away from that in terms of are you putting in like 100% utilization of the 1,000 square foot facility that you mentioned?

偉大的。最後一個問題，關於您提到的 Linea IVT 每年收入高達 1500 萬美元的預測，我們可以從中得出哪些假設，即您是否將 1,000 個設備的利用率達到 100%您提到的平方英尺設施？

Yeah. The capacity is actually slightly greater than at a 100% utilization. Of course, you never want to get to 100% utilization, but the facilities are quite cloneable, if you'll pardon the pun. It would be easy to prepare additional space. I can see a future where our customers are beginning to lay out their plans for pharmacokinetics and toxicology and clinical trials and their approach to FDA. And not only will they be placing orders, but I suspect they'll be booking time. And so as that begins to happen, we have to ensure that we have the capacity to accommodate more time as it were. And that will be a straightforward process. We've already mapped out how to do it, so we're set and ready to go.

是的。此容量實際上略大於 100% 利用率時的容量。當然，您永遠不想達到 100% 的利用率，但如果您能原諒這個雙關語的話，這些設施是可以克隆的。準備額外的空間很容易。我可以預見未來，我們的客戶將開始製定他們的藥物動力學、毒理學和臨床試驗計劃以及他們向 FDA 申請的方法。他們不僅會下訂單，而且我懷疑他們還會預訂時間。因此，當這種情況開始發生時，我們必須確保我們有能力容納更多的時間。這將是一個簡單的過程。我們已經計劃好瞭如何去做，所以我們已經準備好了。

Great. Thank you so much for the update, gentlemen.

偉大的。非常感謝您的更新，先生們。

Thank you.

謝謝。

(Operator Instructions) Jeffrey Bernstein, Silverberg Bernstein Capital.

（操作員指令）Jeffrey Bernstein，Silverberg Bernstein Capital。

Hey, guys. I just wanted to understand when you talked about being benchmarked against competitors and having a higher speed of production, are we talking about the enzymatic guys, like Twist and Anza, those kinds of folks?

大家好。我只是想了解，當您談到與競爭對手進行基準比較並提高生產速度時，我們是在談論像 Twist 和 Anza 這樣的酶人員嗎？

Well --

出色地--

I'll take that, Jim, if you want.

吉姆，如果你願意的話，我可以接受。

Sure.

當然。

Okay. Hey, Jeff. So yes and no. We're talking about some of our competitors in the enzymatic scale-up, not the enzymatic synthesis. So we don't know what customers they are particularly. All we know is that we are being benchmarked against other enzymatic manufacturers, and we are exceeding their turnaround plan.

好的。嘿，傑夫。所以是和不是。我們談論的是酶法放大方面的一些競爭對手，而不是酶法合成方面。所以我們不知道他們具體是什麼客戶。我們所知道的是，我們正在與其他酵素製造商進行比較，並且我們正在超越他們的周轉計劃。

Okay. So those would potentially be like CDMOs that are offering these capabilities?

好的。那麼那些可能會像 CDMO 一樣提供這些功能呢？

Exactly, right? So again, there's two enzymatic uses. There's the synthesis of that initial template, which is not what we do. And then there's use of enzymatic manufacturing to scale up, which is what we do. (inaudible)

非常正確？同樣，酶有兩種用途。這是初始模板的綜合，這不是我們所做的。然後使用酵素法生產來擴大規模，這就是我們所做的。（聽不清楚）

Yeah. Okay, that's great. Thank you.

是的。好的，太好了。謝謝。

(Operator Instructions) This concludes our question-and-answer session. I would like to turn the conference back over to James Hayward for any closing remarks.

（操作員說明）我們的問答環節到此結束。我想將會議轉回給詹姆斯·海沃德發表閉幕詞。

Well, thank you all for joining us, and we look forward to keeping you closely apprised as we move ahead through these exciting times. Thank you.

好吧，感謝大家加入我們，我們期待在我們度過這些激動人心的時刻時隨時向您通報情況。謝謝。

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。