BNB Plus Corp (BNBX) 2025 Q1 法說會逐字稿

Good day and welcome to the Applied DNA Sciences 1st quarter fiscal 2025 financial results. (Operators Instructions)

您好，歡迎閱讀應用 DNA 科學公司 2025 財年第一季財務表現。（操作人員指示）

Please note this event is being recorded. I would now like to turn the conference over to Sanjay Harry, head of investor relations. Please go ahead.

請注意，該事件正在被記錄。現在，我想將會議交給投資者關係主管桑傑哈利 (Sanjay Harry)。請繼續。

Thank you, David. Good afternoon and welcome to the Applied DNA's first quarter fiscal 2025 financial results conference call, where we will discuss our financial and operational performance, business progress, and growth opportunities. Joining me on the call today are James Hayward, our Chairman and CEO, Judith Murrah, our recently appointed President, Beth Jantzen, our Chief Financial Officer. And Clay Shorrock, our Chief Legal Officer, and the newly appointed President of our LineaRx subsidiary.

謝謝你，大衛。下午好，歡迎參加 Applied DNA 2025 財年第一季財務業績電話會議，我們將討論我們的財務和營運業績、業務進展和成長機會。今天與我一起參加電話會議的還有我們的董事長兼執行長詹姆斯‧海沃德 (James Hayward)、我們新任總裁朱迪思‧默拉 (Judith Murrah) 和我們的財務長貝絲‧詹岑 (Beth Jantzen)。還有我們的首席法律長兼新任 LineaRx 子公司總裁 Clay Shorrock。

(Events Instructions)

(活動須知)

Before we get started, let me take this opportunity to remind you that our remarks today may include forward-looking statements. I refer you to slide 3 of the presentation.

在我們開始之前，請允許我藉此機會提醒您，我們今天的評論可能包含前瞻性陳述。請您參閱簡報的第 3 張投影片。

And our Form 10-Q 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.

我們的 10-Q 表中列出了可能導致公司實際績效和結果與任何前瞻性陳述中表達或暗示的結果有重大差異的重要風險因素。

We undertake no obligation to update or revise any forward-looking statements or other information provided on this call as a result of new information or future results or developments.

我們不承擔根據新資訊或未來結果或發展更新或修改本次電話會議中提供的任何前瞻性陳述或其他資訊的義務。

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

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

Thank you, Sanjay, and good afternoon, everyone.

謝謝你，桑傑，大家下午好。

First, let me set the agenda for our call today.

首先，讓我介紹一下我們今天通話的議程。

I will provide a high Haematology-level overview of the finances of the company.

我將從血液學角度對公司的財務狀況進行高水準的概述。

Next, James will briefly walk you through our important milestones achieved during fiscal year 2024.

接下來，詹姆斯將簡單介紹我們在 2024 財年實現的重要里程碑。

Then Clay will provide an update on the LRX business and its growth strategy, and finally Judith will provide you with an update on our operations.

然後，Clay 將向您介紹 LRX 業務及其成長策略的最新情況，最後 Judith 將向您介紹我們營運的最新情況。

Prefacing my review of our financial results for the quarter and to put our performance into its necessary context, during the 1st quarter, we initiated a strategic restructuring intended to bolster our cash reserves and optimize our cost structure.

在回顧本季的財務表現之前，為了將我們的業績放在必要的背景下，我們在第一季度啟動了一項策略重組，旨在增加現金儲備並優化成本結構。

This initiative was undertaken to reduce our cash burn rate and support the growth of our synthetic DNA manufacturing strategy via our LineaRx subsidiary.

採取這項措施是為了降低我們的現金消耗率，並透過我們的子公司 LineaRx 支持我們的合成 DNA 製造策略的成長。

Having laid much of the necessary groundwork to support this strategy in fiscal '24, The restructuring reflects our belief that LineaRx offers the greatest potential to create sustainable value for our shareholders.

我們已經在24財年為支持這項策略奠定了許多必要的基礎，而此次重組反映了我們的信念：LineaRx 最有可能為我們的股東創造永續價值。

Our October 2024 financing supports LineaRx during what we expect to be a year of execution in fiscal 2025.

我們預計 2024 年 10 月的融資將為 LineaRx 在 2025 財年的執行期間提供支援。

A point reinforced last month with the certification of our GMP site 1 facility, which James and Clay will elaborate on this point in their remarks.

上個月我們通過了 GMP 站點 1 設施的認證，這再次強調了這一點，James 和 Clay 將在他們的演講中詳細闡述這一點。

With our quarterly results press release today, we are announcing our exit from the DNA tagging and security products and services business segment. We anticipate the wind down to be completed by the end of the current quarter.

在今天發布的季度業績新聞稿中，我們宣布退出 DNA 標記和安全產品和服務業務部門。我們預計本季末將完成清理工作。

As a result, we implemented a workforce reduction of approximately 20% of total headcount related primarily to employees in this segment. We will incur a one-time charge of approximately $300,000 in the quarter ending March 31, related to this action.

因此，我們實施了約 20% 的總員工裁員計劃，主要裁減該部門的員工。在截至 3 月 31 日的季度中，我們將因此行動而產生約 30 萬美元的一次性費用。

Turning to our financial results for the 1st quarter and beginning with our statement of operations.

回顧我們第一季的財務業績，首先從我們的營運報表開始。

Total revenues for the first quarter of fiscal '25 were $1.2 million compared with $891,000 for the same period of fiscal '24. The YoY increase was a result of higher product revenues from our DNA tagging business segment and from an increase in our textiles isotopic testing services revenue.

25 財年第一季的總收入為 120 萬美元，而 24 財年同期的總收入為 891,000 美元。年比成長是由於我們的 DNA 標記業務部門的產品收入增加以及紡織品同位素測試服務收入增加。

Our Operating loss for the first quarter was $3.0 million compared with $3.8 million in the prior year period. This improvement in our operating loss is primarily attributable to a lower selling general and administrative costs YoY related to lower stock-based compensation expense and to a lesser extent from a decrease in consulting expenses. Resulting from the closure of the DNA tagging segment's European subsidiary.

我們第一季的營業虧損為 300 萬美元，而去年同期的營業虧損為 380 萬美元。我們營業虧損的改善主要歸因於銷售一般及行政開支年減，這主要與股票薪酬費用下降有關，而較小程度上也歸因於諮詢費用的減少。源自於 DNA 標記部門歐洲子公司的關閉。

Net loss for the first quarter was $2.7 million compared with $1.1 million in the prior year period. I remind shareholders that our net loss includes an unrealized gain on the change in the fair value of warrants classified as a liability, which has an inverse relationship with our stock price. For this reason, we highlight operating loss as best representing the company's operations.

第一季淨虧損為 270 萬美元，去年同期為 110 萬美元。我提醒股東，我們的淨虧損包括歸類為負債的認股權證公允價值變動的未實現收益，這與我們的股價呈現反比關係。因此，我們強調營業虧損最能代表公司的營運狀況。

Adjusted EBITDA for the first quarter improved to a negative $2.9 million compared with a negative $3.2 million in the prior year period.

第一季調整後 EBITDA 改善至負 290 萬美元，去年同期為負 320 萬美元。

Now turning to our balance sheet, Cash and Cash equivalents on December 31, totalled $9.3 million, which includes net proceeds of approximately $5.7 million from our October offering and Series A warrant exercises of $509,000. This compares to cash and cash equivalent balance of $6.4 million on September 30, '24.

現在回顧我們的資產負債表，12 月 31 日的現金和現金等價物總計 930 萬美元，其中包括 10 月份發行的約 570 萬美元的淨收益和 A 系列認股權證行使的 509,000 美元。相比之下，24 年 9 月 30 日的現金和現金等價物餘額為 640 萬美元。

As of December 31, our Accounts Receivable stood at approximately $912,000.

截至 12 月 31 日，我們的應收帳款約為 912,000 美元。

Our average monthly cash burn is just over $1.2 million fiscal YTD and essentially fat flat with the same period in the prior year. Our average monthly cash burn for the fourth quarter of fiscal 2024 was $1.3 million.

我們今年財政年度迄今的平均每月現金消耗略高於 120 萬美元，與去年同期基本持平。我們 2024 財年第四季的平均每月現金消耗為 130 萬美元。

Cash and cash equivalent on January 31, '25 was $8.2 million. This figure includes additional Series A warrant exercises totalling approximately $215,000.

25 年 1 月 31 日的現金和現金等價物為 820 萬美元。該數字包括額外的 A 系列認股權證行使，總額約為 215,000 美元。

Our just filed 10-Q maintains a disclosure from our prior form 10-K of a substantial doubt of a going concern. Our ability to alleviate the going concern is dependent on our ability to further implement our business plan and generate revenues or raise capital.

我們剛提交的 10-Q 表格保留了先前的 10-K 表格對持續經營有重大疑慮的揭露。我們緩解持續經營的能力取決於我們進一步實施業務計劃並創造收入或籌集資金的能力。

We sought shareholder approval for the exercisability of the warrants issued in the October 2024 financing on January 23, in a special meeting that was adjourned due to a lack of quorum.

我們於 1 月 23 日召開了特別會議，尋求股東批准行使 2024 年 10 月融資中發行的認股權證，但該會議因法定人數不足而休會。

We will reconvene the meeting tomorrow at 11:00 a.m. Eastern time, and we encourage all shareholders who own shares as of the record date of November 25, 2024, who have not yet voted their shares on the proposal to vote.

我們將於明天東部時間上午 11:00 重新召開會議，我們鼓勵所有截至 2024 年 11 月 25 日記錄日持有股份但尚未對該提案進行投票的股東進行投票。

As of the January 23, meeting, 80% of all shares that were voted did so in Favor of the proposal.

截至 1 月 23 日的會議，80% 的投票贊成該提案。

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

我的準備好的發言到此結束。感謝您今天加入我們。我現在將電話轉給詹姆斯，請他發表評論，詹姆斯。

Thank you, Beth.

謝謝你，貝絲。

And good afternoon, everyone.

大家下午好。

Thank you all for joining us on today's call.

感謝大家參加今天的電話會議。

I want to begin by addressing our strategic restructuring.

首先我想談談我們的策略重組。

The restructuring reflects our full commitment to rebuilding shareholder value through an optimized cost structure, prudent financial management, and a deeper focus on LineaRx.

重組反映了我們透過優化成本結構、審慎的財務管理和對 LineaRx 的更深關注來重建股東價值的充分承諾。

Post pandemic, emergent trends in biotherapeutics and interest among the investor community has centered chiefly on our LineaRx subsidiary and its ability to enzymatically produce DNA at scale to meet the growing demand for alternatives to plasmid DNA.

疫情過後，生物治療領域的新興趨勢和投資者群體的興趣主要集中在我們的 LineaRx 子公司及其大規模酶法生產 DNA 的能力上，以滿足對質粒 DNA 替代品日益增長的需求。

In particular, in the last 18 months we have seen an acceleration in the pace of LineaRx's operational progress.

特別是在過去的 18 個月中，我們看到 LineaRx 的營運進展速度加快。

Interest and feedback on our Linea DNA and Linea IVT platforms have exceeded even our most optimistic expectations.

對我們的 Linea DNA 和 Linea IVT 平台的興趣和回饋甚至超出了我們最樂觀的預期。

The biotherapeutics market is ready for what we have to offer. And as we will talk about on this call, we are now ready to deliver.

生物療法市場已準備好接受我們的產品。正如我們在本次電話會議中談到的那樣，我們現在已經準備好交付了。

We recognize that while each of our business segments offered their own ROI, but cumulatively these disparate ROI's blur our path to profitability. This droves our decision to exit our DNA tagging business segment and implement the workforce reduction. Customs have been informed and certain of them will be supported for a period of time.

我們認識到，雖然我們的每個業務部門都提供了自己的投資回報率，但這些不同的投資回報率累積起來模糊了我們的獲利之路。這促使我們決定退出 DNA 標記業務部門並實施裁員。已通知海關，部分海關將在一段時間內獲得支援。

This goal 2024 had significant successes. We did not have the benefit of a 4th quarter investor call. Therefore, let me summarize certain key milestones we achieved during the year. Then Clay and I will address our strategy for fiscal 2025.

2024年這一目標取得了重大成功。我們沒有從第四季的投資者電話會議中獲益。因此，讓我總結一下我們在這一年中實現的一些關鍵里程碑。然後，克萊和我將討論我們的 2025 財年策略。

So, in fiscal 2024, we validated our Linea IVT platform.

因此，在 2024 財年，我們驗證了我們的 Linea IVT 平台。

Data generated internally and with the CDMO partner were conclusive. Our platform demonstrates a reduction in problematic double stranded RNA contamination on a commercial scale and is cost neutral to legacy manufacturing platforms.

內部和 CDMO 合作夥伴產生的資料具有決定性。我們的平台證明了在商業規模上減少了有問題的雙股 RNA 污染，並且對於傳統製造平台而言成本是中性的。

Linea DNA also entered the clinic. We announced that the Institute of Haematology and Blood Transfusion, or UHBT in Prague, received approval for and initiated a phase one trial of a first-in-human CAR-T clinical trial.

Linea DNA也進入了臨床。我們宣布，布拉格血液學和輸血研究所（UHBT）獲得批准並啟動了首次人體 CAR-T 臨床試驗的第一階段試驗。

UHBT's therapy utilizes Linea DNA as a critical component of its CAR-T therapy to enable a rapidly manufacturable, viral vector-free workflow for the treatment of relapsed and or refractory acute myeloid leukaemia.

UHBT 的療法利用 Linea DNA 作為其 CAR-T 療法的關鍵組成部分，從而實現快速製造、無病毒載體的工作流程，用於治療復發或難治性急性髓細胞白血病。

This approval highlights the first instance of regulatory consent of Linea DNA's use in a clinical setting, a key milestone.

這項批准標誌著 Linea DNA 在臨床環境中首次獲得監管部門同意，這是一個重要的里程碑。

LineaRx customer acquisition rate has exceeded our expectations. In fiscal 2024, we engaged over 25 customer projects, and we expect multiple projects to enter the clinic in calendar 2025.

LineaRx 的客戶獲取率超出了我們的預期。在 2024 財年，我們參與了超過 25 個客戶項目，我們預計多個項目將在 2025 年進入臨床階段。

Furthermore, in advance of our GMP certification, Multiple customers validated us as a GMP supplier.

此外，在我們獲得 GMP 認證之前，已有多家客戶驗證我們是 GMP 供應商。

As part of our strategic restructuring, the board promoted Judith Murrah to President, where she will oversee a continued drive toward operational excellence and quality across our business segments. Congratulations Judith.

作為我們策略重組的一部分，董事會將 Judith Murrah 提升為總裁，她將負責監督我們各個業務部門繼續努力實現卓越營運和品質。祝賀朱迪思。

In a moment Judith will discuss her role in greater detail.

朱迪思稍後會更詳細地討論她的角色。

Similarly, the board has given the additional responsibility of President of LineaRx. to Clay Shorrock. Congratulations, Clay.

同樣，董事會也賦予了 LineaRx 總裁的額外職責。致克萊‧肖羅克 (Clay Shorrock)。恭喜你，克萊。

In addition to his corporate officer duties in recent years, Clay has led global sales and business strategy for LineaRx and has cultivated a mark-key list of customers.

除近年來擔任公司高階主管職務外，Clay 還領導 LineaRx 的全球銷售和業務策略，並培養了一群關鍵客戶。

Applied DNA clinical labs secured New York State Department of Health LDT approval. For TR8 PGx, our pharmacogenomics assay that forms the basis for our PGx testing service and we secured an expansion in use for our (Mbox) essay. And we are now licensed to accept samples from all 50 states.

應用DNA臨床實驗室獲得了紐約州衛生部LDT的批准。對於 TR8 PGx，我們的藥物基因組學檢測構成了我們的 PGx 檢測服務的基礎，並且我們確保了我們 (Mbox) 論文的使用擴展。我們現已獲得許可接受來自所有 50 個州的樣品。

Finally, last month, our GMP site 1 was certified operational as an ISO 7 space with ISO 5 workspaces. With this site we have demonstrated a low-CAPEX approach to enzymatic DNA production at scale. Empowering our entry into long-term GMP supply agreements.

最後，上個月，我們的 GMP 站點 1 被認證為具有 ISO 5 工作空間的 ISO 7 空間。透過這個站點，我們展示了一種低資本支出的大規模酶促 DNA 生產方法。使我們能達成長期 GMP 供應協議。

Now let me turn the call over to Clay to offer some specific insights into LineaRx's plans for fiscal 2025.

現在，讓我將電話轉給 Clay，請他就 LineaRx 2025 財年計畫提供一些具體見解。

Well, thank you, Jim. First, I want to thank the Applied DNA Board of Directors and management team for the opportunity to lead LineaRx as we approach. What I believe is an inflection point in a trajectory.

好吧，謝謝你，吉姆。首先，我要感謝 Applied DNA 董事會和管理團隊給予我領導 LineaRx 的機會。我相信這是軌跡的轉捩點。

Today of you who are new to our story, I with applied DNA since 2016, sitting in various legal and business roles. My background is in biology and intellectual property, and I have 15 years of legal and business experience. I have a passion for building companies, and I believe with the plan we have in place, LineaRx will be a growth engine for applied DNA.

今天，各位是新加入我們故事的人，我自 2016 年以來一直從事應用 DNA 工作，擔任過各種法律和商業職位。我的背景是生物學和智慧財產權，並且擁有15年的法律和商業經驗。我對創辦公司充滿熱情，我相信憑藉我們制定的計劃，LineaRx 將成為應用 DNA 的成長引擎。

Now since the COVID-19 pandemic, the growth trajectory for enzymatically produced DNA has rapidly increased. As you mentioned, with over 25 active projects in fiscal 2024, we see a strong market demand for our Linea DNA and Linea IVT platforms.

自 COVID-19 疫情爆發以來，酵素法生產的 DNA 的成長軌跡迅速增加。正如您所說，2024 財年有超過 25 個活躍項目，我們看到市場對我們的 Linea DNA 和 Linea IVT 平台的強勁需求。

With our initial GMP site now online, we are focused on monetizing this demand. So, to this end, our commercial emphasis is threefold.

隨著我們最初的 GMP 網站上線，我們專注於將這項需求貨幣化。因此，為此，我們的商業重點有三個面向。

First, to sell our GMP capacity for IVT templates. Second, to develop additional LineaRx products and capabilities. And third, to leverage our platform's scalability with minimal cap backs to de-risk growth and reach break-even.

首先，銷售我們的 IVT 模板的 GMP 產能。第二，開發更多 LineaRx 的產品和功能。第三，利用我們平台的可擴展性，以最少的資本回報來降低成長風險並實現收支平衡。

So, first, as a quick primer, mRNA is made from a DNA starting material called an in vitro transcription or IVT template. It's these IVT template materials that we are ready to produce in our GMP facility.

因此，首先，作為快速引物，mRNA 由稱為體外轉錄或 IVT 模板的 DNA 起始材料製成。我們準備在 GMP 設施中生產這些 IVT 模板材料。

The mRNA market continues to grow with almost 500 therapies in the global pipelines. We believe each of these therapies represents a manufacturing opportunity to produce IVT templates at our new GMP facility.

mRNA 市場持續成長，全球正在研發的療法近 500 種。我們相信，每種療法都代表著在我們新的 GMP 工廠生產 IVT 模板的製造機會。

Based on our current customer interactions, the initial revenue opportunity for LineaRx for IVT templates used in the production of phase one clinical trial materials varies. It ranges from about $50,000 to $1 million per opportunity for IVT templates alone. Order about $150,000 to $3 million per opportunity for IVT templates sold with corresponding (LineaRx) under the Linea IBT platform. These opportunities grow rapidly as the projects progress through the clinical phases and eventually into commercial supply.

根據我們目前的客戶互動，LineaRx 用於生產第一階段臨床試驗材料的 IVT 模板的初始收入機會有所不同。僅 IVT 模板一次機會的價值就約為 50,000 美元至 100 萬美元。在 Linea IBT 平台下，與相應（LineaRx）一起銷售的 IVT 模板每次訂購機會約為 15 萬至 300 萬美元。隨著專案進入臨床階段並最終進入商業供應階段，這些機會迅速增長。

It's against this exciting backdrop that we enter 2025 with a robust sales pipeline for GMP IVT templates. We are currently in the final stages of project development with a Boston-based mRNA therapeutic developer for potential GMP supply.

正是在這種令人興奮的背景下，我們帶著強勁的 GMP IVT 模板銷售管道進入 2025 年。我們目前正與位於波士頓的 mRNA 治療開發商進行專案開發的最後階段，以獲得潛在的 GMP 供應。

If development is successfully completed, we anticipate GMP manufacturing for this customer in the May-June time frame.

如果開發成功完成，我們預計將在5月至6月為該客戶進行GMP生產。

In addition, we continue to work on closing GMP manufacturing contracts with several CDMOs and therapeutic developers that have undergone successful evaluations of our technology and are targeting the clinic in the next 12 months.

此外，我們將繼續致力於與多家 CDMO 和治療開發商簽訂 GMP 製造合同，這些公司已成功評估了我們的技術，並計劃在未來 12 個月內投入臨床開發。

To help further stand our sales funnel, during our restructuring, we created a new multi-person sales team within the LineaRx. This organization will be led by a Vice President level.

為了進一步鞏固我們的銷售管道，在重組期間，我們在 LineaRx 內部創建了一個新的多人銷售團隊。該組織將由副總裁級別領導。

Employee for which we seek to hire an industry key opinion leader. We plan to have these position staff by the end of the current quarter. In addition, we have increased our attendance at trade shows and are in the process of overhauling the LineaRx website and marketing materials.

我們希望聘請一位行業關鍵意見領袖的員工。我們計劃在本季末完成這些職位的人員配備。此外，我們增加了參加貿易展會的次數，並正在徹底改造 LineaRx 網站和行銷資料。

We're in the late stages of development of a new and proprietary Enzyme and buffer system to increase the manufacturing yields and sequence fidelity of our Linea DNA. In addition to being a valuable sales tool as a proprietary technology, we believe this new enzyme, once launched, will provide us with a distinct advantage over enzymatic DNA producers while at the same time potentially improve our margin profile through lower cost of goods and higher DNA yields.

我們正處於開發的新型專有酶和緩衝系統的後期階段，以提高我們的 Linea DNA 的製造產量和序列保真度。除了作為一項專有技術成為寶貴的銷售工具之外，我們相信這種新酵素一旦推出，將為我們提供比酵素法 DNA 生產商更明顯的優勢，同時透過降低商品成本和提高 DNA 產量有可能提高我們的利潤率。

Now, history shows us that rarely does a single product make for a successful business, and we're no different.

現在，歷史告訴我們，單一的產品很少能夠成就一家成功的企業，我們也不例外。

So as such, we have developed. LRx to be a multi-product business. While IVT templates have been our initial focus, LRx built a diverse revenue base in fiscal 2024. To support additional growth in non-IVT template segments. We are currently engaged in the development of several new forms of Linea DNA.

這樣，我們就發展了。LRx 是一家多產品企業。雖然 IVT 模板一直是我們最初的關注重點，但 LRx 在 2024 財年建立了多元化的收入基礎。支援非 IVT 模板段的額外增長。我們目前正在開發幾種新形式的 Linea DNA。

Then we are announcing today the availability of a new type of Linea DNA we call Linea donor DNA for use as a donor DNA in CRISPR gene editing applications. Linea donor DNA is a high fidelity, double stranded. Blunt ended form of DNA optimized for use in CRISPR-mediated homology director repair or HDR applications which are commonly used in a wide range of gene editing modalities.

今天我們宣布推出一種新型 Linea DNA，我們稱之為 Linea 供體 DNA，可用作 CRISPR 基因編輯應用中的供體 DNA。Linea 供體 DNA 是高保真度、雙股的。平端形式的 DNA 經過優化，可用於 CRISPR 介導的同源性指導修復或 HDR 應用，這些應用通常用於廣泛的基因編輯方式。

We believe that enzymatically produced linear donor DNA has numerous advantages over plasmid donor DNA, and like IVT sampling, the market is primed for a large-scale cell-free alternative.

我們相信，酵素法產生的線性供體DNA比質粒供體DNA具有許多優勢，與IVT採樣一樣，市場也為大規模無細胞替代品做好了準備。

Linear donor DNA is available now for research use only with targeted GMP availability later in this calendar year.

線性供體 DNA 現僅可用於研究，並將於今年稍後推出 GMP 版本。

In addition, we are actively upgrading our GMP capabilities to allow for the manufacture of Linea DNA drug substance and drug product. These upgrades will allow Plenty of DNA is to be used in a wide range of high value clinical applications and genetic medicine ranging from CAR-T manufacturing to personalized DNA vaccines.

此外，我們正在積極升級我們的 GMP 能力，以生產 Linea DNA 藥物物質和藥物產品。這些升級將使Plenty of DNA能夠用於從CAR-T製造到個人化DNA疫苗等廣泛的高價值臨床應用和基因醫學。

Turning finally to our growth strategy.

最後談談我們的成長策略。

Our ability to manufacture a scale is now proven and our initial GMP facility is operational. We are now sharpening our focus on using our platform's low-CAPEX requirements to achieve growth and eventually profitability.

我們製造規模的能力現在已得到證明，我們初始的 GMP 設施已投入運作。我們現在正集中精力利用我們平台的低資本支出要求來實現成長並最終實現盈利。

As opposed to GMP platinum-based DNA manufacturing that require large environmentally controlled spaces and expensive instrumentation, the Linea DNA platform uses bench-top instruments with minimal space requirements. Our initial GMP facility was designed to use modular cleanroom designs and have an end-to-end manufacturing workflow in less than 1,000 square feet of environmentally controlled space.

與需要大型環境控制空間和昂貴儀器的 GMP 鉑基 DNA 製造不同，Linea DNA 平台使用對空間要求極小的桌上型儀器。我們最初的 GMP 設施採用模組化無塵室設計，在不到 1,000 平方英尺的環境控制空間內實現端到端的製造工作流程。

Our bench job instrumentation is cost effective, and since we manufacture in smaller volumes of plasma DNA, our purification instruments are smaller and less expensive.

我們的桌上型儀器具有成本效益，並且由於我們生產的血漿 DNA 體積較小，因此我們的純化儀器更小且更便宜。

In addition, PCR has fewer raw materials and potential contaminants in plasma DNA workflows, which leads to lower incoming and batch release QC costs.

此外，PCR 在血漿 DNA 工作流程中所需的原料和潛在污染物較少，從而降低了進貨和批次放行的 QC 成本。

We believe these unique attributes of our platform enable our ability to rapidly scale our GMP manufacturing using a simple copy and paste approach for a fraction of the CAPEX that would be required for legacy DNA manufacturing technologies. This results in two near term benefits. First, using our simple copy and paste approach, we can scale and deal real time with our production contracts. I'll make other CDMOs. We do not face to build it and hopefully they will come dilemma.

我們相信，我們平台的這些獨特屬性使我們能夠使用簡單的複製貼上方法快速擴展我們的 GMP 製造，而所需資本支出僅為傳統 DNA 製造技術所需資本支出的一小部分。這會帶來兩個短期效益。首先，使用簡單的複製貼上方法，我們可以擴展並即時處理生產合約。我會製作其他 CDMO。我們不面臨建造它並且希望他們會來的困境。

Where it's necessary to build a large, complex, and capital-intensive facility before commercial contracts are signed. Instead, because we can rapidly build additional manufacturing capacity via the construction of small identical modular clean rooms, we can align CAPEX spend.

在簽訂商業合約之前，有必要建造大型、複雜且資本密集的設施。相反，由於我們可以透過建造小型相同的模組化潔淨室來快速建立額外的製造能力，因此我們可以調整資本支出。

To closely mimic our conventual contract timing, thereby, reducing our balance sheet risk.

緊密模仿我們約定的合約時間，從而降低我們的資產負債表風險。

Second, we believe that our target CAPEX investment needed to achieve DNA production capacity necessary to support our profitability is significantly less than other legacy.

其次，我們認為，實現支持我們獲利能力所需的 DNA 生產能力的目標資本支出投資明顯低於其他傳統投資。

Technologies, particularly in the biologic space. Based on our current cost of modular cleaner construction and instrumentation, each of our clean room costs less than $1 million yet each has a potential revenue opportunity of $10 million to $30 million per year depending on the applicable.

技術，特別是生物領域的技術。根據我們目前的模組化清潔器建造和儀器儀表的成本，我們的每個潔淨室的成本不到 100 萬美元，但每個潔淨室每年都有 1000 萬至 3000 萬美元的潛在收入機會，具體取決於適用情況。

Mix of products. This we believed, coupled with a strong margin profile for our products allowed the company to break-Even on a fraction of the capital investment that has historically been required for the biologic CDMOs.

產品混合。我們相信，這一點加上我們產品的強勁利潤率，將使公司僅靠生物製劑 CDMO 歷史上所需的一小部分資本投資就能實現收支平衡。

In conclusion, we believe the operational launch of our GMP facility is a pivotal juncture for this company, representing the final piece of the multi-year business strategy to commercialize our expertise in PCRV's production of DNA into new markets with higher margin programs.

總而言之，我們相信 GMP 設施的投入營運是該公司的關鍵時刻，代表了多年商業策略的最後一部分，該策略旨在將我們在 PCRV DNA 生產方面的專業知識商業化，進入利潤率更高的新市場。

We look forward to what the future holds. Now, Judith, over to you.

我們期待未來會發生什麼。現在，朱迪思，輪到你了。

Thank you, Clay, and good afternoon, everyone. It's my pleasure to speak with you today.

謝謝你，克萊，大家下午好。我很高興今天能與您交談。

Let me use this occasion to first thank James, my fellow officers, and our board of directors for the opportunity to continue to lead applied DNA operations with now a broader charter as President of the company.

我要藉此機會首先感謝詹姆斯、我的同事們以及我們的董事會，感謝他們給予我機會以公司總裁的身份繼續領導應用 DNA 業務，並且現在擁有更廣泛的職權範圍。

From James's and Clay's comments, it should be clear that we are a highly innovative company. Sitting at the precipice of tremendous market opportunity. I'm eager now to expand my efforts and further unlock value for all of our stakeholders.

從詹姆斯和克萊的評論中可以清楚看出，我們是一家高度創新的公司。面臨巨大的市場機會。我現在渴望擴大我的努力並進一步為我們所有的利害關係人釋放價值。

My immediate and ongoing focus will be centered on overseeing the company's operations, driving operational excellence and enabling the company in setting and achieving its key business objectives.

我目前和持續的關注重點將是監督公司的營運、推動卓越營運以及幫助公司製定和實現其關鍵業務目標。

How well we orchestrate sales opportunity closure, product mix, quality, delivery volumes and schedules to ensure top-notch customer success. These will determine much of our future success.

我們如何協調銷售機會的結束、產品組合、品質、交付量和時間表以確保一流的客戶成功。這些將在很大程度上決定我們未來的成功。

Also in my new role, I will work with the team in orchestrating deliberate resource allocation towards growth initiatives, while at the same time we drive and maintain spending discipline and a quality culture.

此外，在我的新職位上，我將與團隊合作，精心安排資源分配給成長計劃，同時推動和維持支出紀律和品質文化。

With GMP execution of the cornerstone, we delivered. And we have a deep bench in how to manage going forward.

以GMP執行為基石，我們順利完成交付。我們在如何進行未來管理方面擁有深厚的儲備。

We are not starting from scratch. We've operated under ISO 90,001 for 10 plus years. We've managed our clinical lab operations at scale and to the high bar of a demanding New York State Department of Health, the FDA, and in direct contact with healthcare providers and their patients.

我們並不是從零開始。我們已依照 ISO 90,001 營運十餘年。我們大規模管理臨床實驗室的運營，達到紐約州衛生部和 FDA 的嚴格標準，並與醫療保健提供者及其患者直接聯繫。

Leveraging this experience, GMP is also predicated on a quality culture. A quality that must permeate every individual, every function, and our pursuit in every opportunity.

利用這項經驗，GMP 也以品質文化為前提。這種特質必須滲透到每一個人、每一個職能以及我們在每一個機會中的追求。

Our customer base resides globally. They have no miss manufacturing schedules. And these force us as a mission critical supplier to adhere to higher level FDA, European Medicine Authority, and Asian regulatory body requirements.

我們的客戶群遍佈全球。他們沒有錯過生產計劃。這些迫使我們作為關鍵任務供應商遵守更高層級的 FDA、歐洲藥品管理局和亞洲監管機構的要求。

We do have the building blocks in place today. To our knowledge, we have today the largest manufacturing capacity for GMP grade PCR produced DNA in North America. Implemented under budget.

我們今天確實已經建立了基礎。據我們所知，我們目前擁有北美最大的 GMP 級 PCR DNA 生產能力。在預算內實施。

This in addition to continuing our supply of RUO and GLP grade materials for IVT templates and genetic medicine and we also offer large scale supply for the IVT markets. We have an initial projected annual IVT template capacity of over 10g. A quantity we actually have delivered annually across several product categories in GLP grade.

除繼續為 IVT 模板和基因醫學供應 RUO 和 GLP 級材料外，我們還為 IVT 市場提供大規模供應。我們初步預計年 IVT 模板產能將超過 10g。事實上，我們每年交付的 GLP 級產品涵蓋多個類別。

For context, 10g is sufficient product capacity for our customers to produce up to 30 million doses of mRNA vaccines. We complement all of this manufacturing capability with a full suite of analytical instruments, stability chambers, and programs to offer our customers, and an operative quality system from incoming materials to outbound product.

就背景而言，10g 的產品容量足以讓我們的客戶生產多達 3,000 萬劑 mRNA 疫苗。我們透過為我們的客戶提供全套分析儀器、穩定室和程序來補充所有這些製造能力，以及從進料到出貨產品的有效品質系統。

Moving to our clinical lab. In the face of the considerable undertaking that has been GMP, our pharmacogenomics testing service treat PGx at Applied DNA Clinical labs, has admittedly been managed at a steady state.

轉移到我們的臨床實驗室。面對GMP這項艱鉅的任務，我們在應用DNA臨床實驗室進行的藥物基因組學檢測服務處理PGx，無疑地一直處於穩定狀態。

Looking forward, we are assessing our markets and our capabilities to evaluate elements that could potentially establish further value in our New York state certified laboratory assets which is a very rare commodity.

展望未來，我們正在評估我們的市場和能力，以評估可能進一步增值我們紐約州認證實驗室資產的因素，這是一種非常稀有的商品。

Under evaluation are such things as more prompting target segments for PGx, the qualification for insurance reimbursement, and the validation of additional diagnostic assays.

正在評估的事情包括為 PGx 提供更多提示目標細分市場、保險報銷資格以及額外診斷檢測的驗證。

In closing, our goals are significant. Our resources are finite. To that end, we will remain prudent in managing our financial structures and the allocations through this restructuring and thereafter to capture the market that we know is out there.

最後，我們的目標十分重大。我們的資源是有限的。為此，我們將透過這次重組，審慎地管理我們的財務結構和分配，並以此佔領我們所知的市場。

We will stay closely tuned to our business operations and market dynamics, ready to modify and refine our business strategy as context may change.

我們將密切關注我們的業務營運和市場動態，並隨時準備根據環境的變化修改和完善我們的業務策略。

I strongly believe that we have the infrastructure, the people, and the determination to execute across all aspects of the company to unlock value for shareholders.

我堅信，我們擁有基礎設施、人才和決心，能夠在公司的各個方面發揮作用，為股東創造價值。

Thank you, and I will now turn the call back over to James for concluding remarks.

謝謝，現在我將電話轉回給詹姆斯，請他作最後發言。

Thank you, Judith.

謝謝你，朱迪絲。

Before opening the call to questions, I want to reinforce some key takeaways from our collective remarks.

在開始提問之前，我想先重申我們集體發言中的一些關鍵要點。

The market is very receptive to our platforms. Our GMP one site is in place, and we can now deliver product ranging from evaluation and RUO to clinical grade. And we have a blueprint for a further expansion of site one as warranted by customer demand.

市場對我們的平台非常接受。我們的 GMP 一站式服務已到位，現在我們可以提供從評估、RUO 到臨床級別的產品。並且，根據客戶需求，我們有進一步擴展一號站點的藍圖。

We have an excellent stable of DNA customers to convert into recurring orders, and those order sizes will increase as these therapies graduate through the late preclinical and clinical phases of their development.

我們擁有一群穩定的優秀 DNA 客戶，可以轉化為定期訂單，而且隨著這些療法進入其開發的後期臨床前和臨床階段，訂單規模將會增加。

We are targeting additional new DNA markets and bolstering our product offering and We recognize that the path to rebuilding shareholder value will come from a combination of disciplined CAPEX and growth through enzymatic DNA production.

我們正瞄準更多的新 DNA 市場並加強我們的產品供應，我們認識到重建股東價值的途徑將來自於嚴格的資本支出與透過酶促 DNA 生產實現的成長的結合。

Well, thank you all for your time and attention this afternoon.

好吧，感謝大家今天下午的時間和關注。

Operator, please open the call to questions.

接線員，請打開電話詢問。

We will now begin the question-and-answer session. (Operators Instructions)

我們現在開始問答環節。（操作人員指示）

Our first question comes from Yi Chen with HC Wainwright. Please go ahead.

我們的第一個問題來自 HC Wainwright 的 Yi Chen。請繼續。

Good afternoon. This is Eduardo on for Yee from HC Wainwright. I was wondering if you could provide any colour on the new linear product. Kind of interested to know how you quantify the opportunity there for these CRISPR therapies versus maybe the kind of conventional IVT or even the existing CAR-T therapies that you guys are developing products for.

午安.這是 HC Wainwright 的 Yee 的 Eduardo。我想知道您是否可以提供有關新線性產品的任何顏色。我感興趣的是，您如何量化這些 CRISPR 療法的機會，以及與傳統 IVT 或甚至您正在開發產品的現有 CAR-T 療法相比的機會。

Sure, absolutely. So nice to meet you, Eduardo. So yeah, so we think that there's a lot of parallels between the IVT template and the donor DNA market, in part, PCR is very good at making blunt ended DNA, and so we looked at the market and saw where there's market opportunities for large scale blunt ended DNA. One of them is IVC templates, the other is HCR donor DNA. So that's the logic there. We can use our existing workflow, no modifications to our manufacturing workflow to make the donor DNA. So, it's an amplification of the kind of existing manufacturing line. In terms of market opportunity, obviously CRISPR and CRISPR-based therapeutics are less mature than mRNA in some ways they're not, but. We do believe it is a very large market, especially in kind of the cell and gene therapy as CAR-T start to move more to the gene editing space versus the viral vector like lentivirus-based manufacturing workflows, and that's something we're very excited about. We also think in vivo gene editing has a future, but I think near term we're really focused on kind of those carte workflows and ex-vivo gene editing.

當然，絕對是如此。很高興認識你，愛德華多。是的，我們認為 IVT 模板和捐贈者 DNA 市場之間有很多相似之處，在某種程度上，PCR 非常擅長製作平端 DNA，因此我們研究了市場並發現了大規模平端 DNA 的市場機會。其中一個是IVC模板，另一個是HCR供體DNA。這就是其中的邏輯。我們可以使用現有的工作流程，無需修改製造工作流程來製造捐贈者的 DNA。所以，這是對現有生產線的擴展。就市場機會而言，顯然 CRISPR 和基於 CRISPR 的療法在某些方面不如 mRNA 成熟，但。我們確實相信這是一個非常大的市場，特別是在細胞和基因治療領域，因為 CAR-T 開始更多地轉向基因編輯領域，而不是基於慢病毒等病毒載體的製造工作流程，這是讓我們非常興奮的事情。我們也認為體內基因編輯具有未來，但我認為短期內我們真正關注的是那些 carte 工作流程和體外基因編輯。

Great, that's really helpful. Then kind of, I was also hoping if I could get any colour on where the revenue increases were coming from, if they were primarily new customer acquisitions or primarily from increased kind of scaling and manufacturing of existing customers.

太棒了，這真的很有幫助。然後，我還希望能夠了解收入成長的來源，主要是來自新客戶的獲取，還是主要來自現有客戶的擴大規模和製造。

So, the two increases came from product revenue. The primary reason for that was a shipment of DNA tagging for the marking of cotton, one of our customers' contracts we have had for a while, and the other bump in revenue this quarter came from increased volume within our isotopic testing services business.

因此，這兩項成長均來自產品收入。主要原因是一批用於棉花標記的 DNA 標籤的發貨，這是我們與客戶簽訂的長期合約之一，本季度收入的另一個增長則來自於我們的同位素測試服務業務量的增加。

Clay, is there anything you'd like to add?

克萊，您還有什麼要補充的嗎？

I would add to the shipment of DNA tagging to a cotton tagging customer is a contract we are currently retaining post restructuring.

我想補充一點，向棉花標籤客戶運送 DNA 標籤是我們目前在重組後保留的合約。

We're able to manufacture that with the same workflows that we have for the LineaRx, so it makes sense to keep that that contract.

我們能夠採用與 LineaRx 相同的工作流程來製造它，因此保留該合約是有意義的。

But now, James, that's all I have to that.

但是現在，詹姆斯，我所能做的就這些了。

Great, thanks so much. And then if I could just have maybe one more kind of in that line of the, you mentioned the AML therapy and I'm curious what the timeline and kind of, I know it's phase one, I think you mentioned first in human the timeline and revenue recognition dynamics that we should expect for that.

太好了，非常感謝。然後，如果我可以再多說一種，您提到了 AML 治療，我很好奇它的時間表和類型，我知道這是第一階段，我想您首先提到了我們應該預期的時間表和收入確認動態。

Yeah, the timeline for that trial, so it is in the Czech Republic. I think phase one is probably about 18 months. It's an interesting therapy in that it's a non-viral CAR-T. It uses a transposon system to actually make the CAR, so we are excited for that. We don't know in terms of revenue opportunity how large it's going to scale because it's a hospital-based trial. It's not run by the commercial entity, but the important part there was twofold. One, we were able to get through the regulatory approval process quite easily. And two, we were chosen over the plasmic competitor because we were faster, but also it eased the regulatory process for the customer.

是的，該審判的時間表是在捷克共和國。我認為第一階段大概需要 18 個月。這是一種有趣的療法，因為它是一種非病毒的 CAR-T。它使用轉座子系統來實際製造CAR，因此我們對此感到非常興奮。由於這是一項基於醫院的試驗，因此我們不知道從收入機會來看它將擴大到多大。它不是由商業實體運營的，但其中的重要部分有兩方面。一，我們能夠相當輕鬆地通過監管審批流程。其次，我們之所以被選中而不是等離子競爭對手，是因為我們的速度更快，也簡化了客戶的監管流程。

So those are two of the main takeaways from that. James, I don't have to feel I don't know if it's a large revenue opportunity in that trial necessarily, but it was critically important validation.

以上就是兩個主要的結論。詹姆斯，我沒有必要覺得我不知道那次試驗是否必然是一個巨大的創收機會，但這是至關重要的驗證。

Right, I think it demonstrates to a broader industry base, the entire CAR-T industry that Linea DNA is an adequate material to utilize in the generation of these therapies and we provide a faster path, which in many cases is Urgently required.

是的，我認為這向更廣泛的行業基礎、整個 CAR-T 行業證明，Linea DNA 是用於生成這些療法的適當材料，並且我們提供了一條更快的途徑，這在許多情況下是迫切需要的。

Wonderful, thanks so much for that and exciting development. Congrats on the quarter.

太棒了，非常感謝，還有令人興奮的發展。恭喜本季取得佳績。

Thank you.

謝謝。

Thanks.

謝謝。

Again, if you have a question, please press "*" and then "1".

再次強調，如果您有疑問，請按“*”，然後按“1”。

This concludes our question-and-answer session. I would like to turn the conference back over to Dr. Hayward for any closing remarks.

我們的問答環節到此結束。我想將會議交還給 Hayward 博士，請他作最後發言。

Well, thank you and thank you everyone for joining us on today's call.

好吧，謝謝大家，也謝謝大家參加今天的電話會議。

Operator, you can now conclude the call.

接線員，您現在可以結束通話了。

The conference is now concluded.

會議現已結束。

Thank you for attending today's presentation. You may now disconnect.

感謝您參加今天的演講。您現在可以斷開連線。