BNB Plus Corp (BNBX) 2023 Q3 法說會逐字稿

Good day, and welcome to the Applied DNA Sciences, Inc., fiscal third-quarter 2023 financial results conference call. (Operator Instructions) Please note, this event is being recorded. I would now like to turn the conference over to Sanjay Hurry, Head of Investor Relations. Please go ahead.

美好的一天，歡迎參加 Applied DNA Sciences, Inc. 2023 財年第三季度財務業績電話會議。 （操作員說明）請注意，正在記錄此事件。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, Berkeley. Good afternoon, everyone, and welcome to Applied DNA's conference call to discuss our third quarter fiscal 2023 financial results. You can 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.

謝謝你，伯克利。大家下午好，歡迎參加 Applied DNA 的電話會議，討論我們 2023 財年第三季度的財務業績。您可以在我們公司網站的投資者關係部分查看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。

Speaking on the call today are Dr. James Hayward, our Chairman, President, and CEO; Beth Jantzen, our Chief Financial Officer; and Clay Shorrock, our 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 the call.

今天在電話會議上發言的是我們的董事長、總裁兼首席執行官 James Hayward 博士； Beth Jantzen，我們的首席財務官；以及我們的首席法務官兼業務開發主管 Clay Shorrock。我們的首席運營官 Judy Murrah 也將回答電話問答部分的問題。

Before we begin, please note that some of the information you will hear today during our discussion may consist of 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 or other information provided on this call as a result of new information or future results or developments.

在我們開始之前，請注意，您今天在我們的討論中聽到的一些信息可能包含前瞻性陳述。我建議您參閱演示文稿的幻燈片 2 和我們不久前提交的 10-Q 表格，了解可能導致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存在重大差異的重要風險因素。我們不承擔因新信息或未來結果或發展而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信息的義務。

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 fiscal third-quarter investor call. I will start this afternoon with an overview of our results for the quarter ended June 30, 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. The preface our performance in the fiscal third quarter, our results reflect a weaker environment for COVID-19 testing demand following the federal declaration in early May that COVID-19 no longer constitutes a public health emergency. Following the declaration, and as noted in our fiscal second quarter call, the City University of New York, our largest diagnostic testing program customer, opted not to renew their contracts for our testing services. The wind-down of the CUNY program began in May, at the end of the academic term and was concluded by mid-June.

謝謝你，桑傑。大家下午好。感謝您參加我們的第三財季投資者電話會議。今天下午，我將首先概述我們截至2023 年6 月30 日的季度業績。然後我會將電話轉給我們的總裁兼首席執行官詹姆斯·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。在我們第三財季的業績前言中，我們的結果反映出，繼 5 月初聯邦宣布 COVID-19 不再構成公共衛生緊急事件之後，COVID-19 檢測需求的環境疲軟。在聲明發布後，正如我們在第二財季電話會議中指出的那樣，我們最大的診斷測試項目客戶紐約市立大學選擇不再續簽我們的測試服務合同。紐約市立大學項目的結束於五月學期結束時開始，並於六月中旬結束。

With this as a backdrop, total revenue for the quarter ended June 30, 2023, was $2.9 million compared to $4.3 million for the same period last year. Offsetting the decline was a year-over-year increase from our therapeutic DNA production segment of approximately $296,000 related to a final delivery under our largest contract for linearDNA to date.

在此背景下，截至 2023 年 6 月 30 日的季度總收入為 290 萬美元，而去年同期為 430 萬美元。我們的治療性 DNA 生產部門同比增長約 296,000 美元，抵消了這一下降，這與我們迄今為止最大的線性 DNA 合同的最終交付有關。

Gross profit was $1.3 million or 44% compared to $1 million or 24% in the prior fiscal year period. The improvement in gross profit margin was primarily driven by improved margins at Applied DNA clinical labs due to improved expense management associated with the CUNY contract and a higher percentage of the segment's revenues attributable to higher margin COVID-19 surveillance testing.

毛利潤為 130 萬美元，即 44%，而上一財年期間的毛利潤為 100 萬美元，即 24%。毛利率的提高主要是由於與紐約市立大學合同相關的費用管理得到改善，以及由於利潤率較高的COVID-19 監測測試導致該部門收入的百分比上升，從而導致Applied DNA 臨床實驗室的利潤率提高。

The operating costs of our molecular diagnostics testing services segment are currently being absorbed by surveillance testing contracts. Total operating expenses increased approximately 6% to $4.1 million from $3.9 million in the prior fiscal year period.

我們的分子診斷測試服務部門的運營成本目前由監督測試合同吸收。總運營費用從上一財年期間的 390 萬美元增加至 410 萬美元，增長約 6%。

The year-over-year increase in total operating expenses primarily reflects an increase in SG&A related to the implementation of quality system automation and an allowance for doubtful accounts to reserve for an account balance that was deemed uncollectible. With the unrealized gain on the change in fair value of the warrants classified as a liability included in our net loss line, we now highlight operating loss as best representing the company's operations.

總運營費用的同比增長主要反映了與實施質量體係自動化相關的SG&A的增加，以及為被視為無法收回的賬戶餘額準備的呆賬備抵的增加。由於認股權證公允價值變動的未實現收益被歸類為負債，並包含在我們的淨虧損線中，因此我們現在強調運營虧損最能代表公司的運營。

Operating loss for fiscal Q3 was flat at $2.9 million compared to the prior fiscal period. Excluding noncash expenses, consolidated adjusted EBITDA for fiscal Q3 was negative $2.1 million compared to negative $2.3 million in the fiscal year ago period. This improvement resulted primarily from our improved gross profit during the third fiscal quarter.

第三財季運營虧損與上一財年持平，為 290 萬美元。不包括非現金支出，第三財季綜合調整後 EBITDA 為負 210 萬美元，而上一財年同期為負 230 萬美元。這一改善主要歸功於我們第三財季毛利潤的提高。

Now turning to our balance sheet. Cash and cash equivalents, excluding restricted cash, totaled $10.8 million on June 30 compared to $12.3 million at March 31. As of June 30, our accounts receivable stood at $683,000. We have since collected the majority of this AR.

現在轉向我們的資產負債表。 6 月 30 日，現金和現金等價物（不包括限制性現金）總計 1,080 萬美元，而 3 月 31 日為 1,230 萬美元。截至 6 月 30 日，我們的應收賬款為 683,000 美元。我們已經收集了該 AR 的大部分內容。

Year to date, our average monthly cash burn is $495,000 compared to $620,000 in the prior comparable period. This improvement is due primarily to increased cash receipts under our CUNY contract as well as lower costs to support the CUNY contract. Average monthly cash burn year to date does not include our restricted cash of $750,000.

今年迄今為止，我們的平均每月現金消耗為 495,000 美元，而去年同期為 620,000 美元。這一改善主要是由於我們紐約市立大學合同下的現金收入增加以及支持紐約市立大學合同的成本降低。今年迄今為止的平均每月現金消耗不包括我們 750,000 美元的限制現金。

Updating our cash burn projections post CUNY contract conclusion, we anticipate a monthly burn of about $1 million per month beginning in the current quarter and moving forward. This projection is contingent on order flow for linearDNA, for IVT templates, the launch of our pharma-genomics business, and DNA tagging projectiles the latter, as we approach the start of the contingencies in the US. It is also contingent on CapEx necessary to establish a linearDNA production capacity suitable for clinical use and to support our ongoing platform development. Based on our recurring losses from operations and continued cash outflows from operating activities included in our just filed Form 10-Q is a disclosure of substantial doubt of a going concern. Our ability to alleviate the going concern is dependent on our ability to implement our business plan further and generate revenues or raise capital.

在 CUNY 合同簽訂後更新我們的現金消耗預測，我們預計從本季度開始並繼續每月消耗約 100 萬美元。隨著美國突發事件的臨近，這一預測取決於線性 DNA、IVT 模板的訂單流、我們藥物基因組學業務的啟動以及後者的 DNA 標記彈丸。建立適合臨床使用的線性 DNA 生產能力並支持我們正在進行的平台開發還取決於資本支出。根據我們剛剛提交的 10-Q 表格中包含的經常性經營虧損和經營活動持續現金流出，披露了對持續經營的重大疑問。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產生收入或籌集資金的能力。

Our cash position on July 31 was approximately $9.6 million.

截至 7 月 31 日，我們的現金頭寸約為 960 萬美元。

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 our call today. In recent quarters, we have made steady progress on our strategic pivot towards the biotherapeutics market, and the unlocking of the full value of our PCR expertise applied to the manufacture of next-generation nucleic acid therapies. Remember, DNA encodes for the transcribed messenger RNA, which itself encodes for the translated amino acid sequence of an expressed protein. The translation may take place in the patient as is the case for the messenger RNA vaccines against SARS-CoV-2 or in vitro when those therapeutic modality is the delivery of a preformed protein, such as a monoclonal antibody or replacement enzyme or a protein-based vaccine.

嗯，謝謝你，貝絲。大家下午好。感謝您今天參加我們的電話會議。最近幾個季度，我們在生物治療市場的戰略重心上取得了穩步進展，並釋放了我們應用於下一代核酸療法製造的 PCR 專業知識的全部價值。請記住，DNA 編碼轉錄的信使 RNA，而信使 RNA 本身編碼表達蛋白質的翻譯氨基酸序列。這種翻譯可以在患者體內發生，就像針對SARS-CoV-2 的信使RNA 疫苗的情況一樣，或者在體外，當這些治療方式是遞送預先形成的蛋白質時，例如單克隆抗體或替代酶或蛋白質，為基礎的疫苗。

After the close of the quarter, we took a significant step toward our -- forward, rather, with our acquisition of Spindle Biotech. When combined with our linearDNA IVT templates, Spindle's proprietary RNA polymerase offers the following advantages: It gives us a differentiated offering with market advantages over conventional IVT mRNA production. It increases the commercial relevance of our platform to the growing pipeline of mRNA therapeutics in development globally. And it substantially increases our mRNA total addressable market with improved economics.

本季度結束後，我們通過收購 Spindle Biotech 邁出了重要的一步。當與我們的線性 DNA IVT 模板結合使用時，Spindle 專有的 RNA 聚合酶具有以下優勢： 與傳統的 IVT mRNA 生產相比，它為我們提供了具有市場優勢的差異化產品。它增加了我們平台與全球不斷增長的 mRNA 療法開發管道的商業相關性。它大大增加了我們的 mRNA 總目標市場，並提高了經濟效益。

The acquisition translates to roughly a four-fold increase in our mRNA total addressable market made relevant through our now integrated offering. As we announced a few weeks ago, we have branded this new integrated platform LineaIVT with the tag line: better mRNA...faster (sic - see slide 8, "better RNA...faster) as shown in this slide.

此次收購使我們的 mRNA 總可尋址市場增加了大約四倍，這通過我們現在的整合產品而變得相關。正如我們幾週前宣布的那樣，我們為這個新的集成平台LineaIVT 貼上標籤：更好的mRNA...更快（原文如此- 參見幻燈片8，“更好的RNA...更快） ，如本幻燈片所示。

In a moment, I'll ask Clay to take you through our business development plan for this new, exciting offering. Our goal is to enhance further the platform's value proposition to mRNA manufacturers and developers and acquire additional evaluation customers while we bring online our cGMP quality production capacity to support the demand for DNA at volumes relevant to both clinical and commercial stages.

稍後，我將請 Clay 向您介紹我們針對這一令人興奮的新產品的業務發展計劃。我們的目標是進一步增強該平台對 mRNA 製造商和開發商的價值主張，並獲得更多評估客戶，同時我們將 cGMP 質量生產能力上線，以支持與臨床和商業階段相關的 DNA 需求。

My presentation today will also detail the non-therapeutic linearDNA revenue opportunities being advanced alongside our mRNA initiatives. In the aggregate, these opportunities represent compelling paths for growth.

我今天的演講還將詳細介紹與我們的 mRNA 計劃一起推進的非治療性線性 DNA 收入機會。總的來說，這些機會代表了引人注目的增長路徑。

Recall that at the start of the fiscal year, we announced the receipt of our largest single purchase order of linearDNA, which is for a diagnostic assay. Now we can reduce linearDNA today at a quality sufficient for commercial diagnostic applications. These applications do not require the compliance of therapeutic DNA. Consequently, the cost to us of diagnostic DNA is less than that of therapeutic DNA.

回想一下，在本財年開始時，我們宣布收到最大的線性DNA單筆採購訂單，該訂單用於診斷分析。現在我們可以以足以滿足商業診斷應用的質量還原線性DNA。這些應用不需要治療性 DNA 的合規性。因此，診斷性 DNA 的成本低於治療性 DNA。

And as we are approaching the start of the cotton ginning season in the US, some of our opportunities are also tied to our supply chain traceability business, catalyzed by the weaker forced labor Protection Act or UFLPA, which is now entering its second year of enforcement.

隨著美國軋棉季節的臨近，我們的一些機會也與我們的供應鏈可追溯性業務相關，這受到了強迫勞動保護法 (UFLPA) 較弱的推動，該法現已進入執行的第二年。

I will now turn the call over to Clay to offer his insights into our acquisition of Spindle, and our path forward in messenger RNA. Clay?

現在我將把電話轉給 Clay，以提供他對我們收購 Spindle 以及我們在信使 RNA 領域的前進道路的見解。黏土？

Thank you, Jim. And good afternoon, everyone. We are very excited about our acquisition of Spindle Biotech, as we feel that the integration with our linearDNA IVT templates to create our LineaIVT platform offers a compelling and differentiated offering to mRNA stakeholders directed two main pain points at mRNA manufacturing. One, to use the plasmid DNA as the starting material; and two, a double-stranded or DS RNA contamination.

謝謝你，吉姆。大家下午好。我們對收購Spindle Biotech 感到非常興奮，因為我們認為與我們的LinearDNA IVT 模板集成以創建我們的LineaIVT 平台，為mRNA 利益相關者提供了引人注目的差異化產品，解決了mRNA 製造的兩個主要痛點。一、以質粒DNA為起始材料；二是雙鍊或 DS RNA 污染。

When utilizing a customer's mRNA production workflow, we believe our LineaIVT platform will produce a higher purity mRNA product with a simplified workflow compared to conventional mRNA production. The mRNA market continues to grow at a breakneck pace with approximately 350 therapies in preclinical or clinical development. These therapies target a wide range of indications ranging from infectious disease to oncology and genetic disorders, with an increasing number of therapies reaching late clinical trials.

當利用客戶的 mRNA 生產工作流程時，我們相信與傳統 mRNA 生產相比，我們的 LineaIVT 平台將通過簡化的工作流程生產更高純度的 mRNA 產品。 mRNA 市場繼續以驚人的速度增長，約有 350 種療法處於臨床前或臨床開發階段。這些療法針對從傳染病到腫瘤學和遺傳性疾病等廣泛的適應症，越來越多的療法進入後期臨床試驗。

mRNA vaccine for common infectious diseases such as RSV2 are on the horizon and represent very large mRNA manufacturing opportunities. It's with these opportunities in mind that we have launched the LineaIVT platform. Our LineaIVT platform is built upon the integration of our linearDNA IVT templates and the proprietary fusion RNA polymerase or RNAP that we acquired from Spindle. The novel RNAP developed by Spindle is a fusion protein consisting of wild-type T7 RNAP and a DNA binding domain.

針對 RSV2 等常見傳染病的 mRNA 疫苗即將問世，代表著巨大的 mRNA 製造機會。正是考慮到這些機會，我們推出了 LineaIVT 平台。我們的 LineaIVT 平台建立在線性 DNA IVT 模板與我們從 Spindle 獲得的專有融合 RNA 聚合酶或 RNAP 集成的基礎上。 Spindle開發的新型RNAP是一種由野生型T7 RNAP和DNA結合域組成的融合蛋白。

The DNA binding domain has a high affinity for certain chemical compacts that can be efficiently added to our linearDNA IVT template via PCR. Our PcrV platform's unique ability to add these chemical modifications efficiently and cost effectively is the enabling technology for Spindle's pipeline, something allowing us to extract the full benefit of the Spindle RNAP.

DNA 結合域對某些化學壓塊具有高親和力，可以通過 PCR 有效地將其添加到我們的線性 DNA IVT 模板中。我們的 PcrV 平台具有高效且經濟高效地添加這些化學修飾的獨特能力，這是 Spindle 管道的支持技術，使我們能夠充分發揮 Spindle RNAP 的優勢。

At the time of the acquisition, Spindle was pre-commercial, but had attracted an enviable list of partners drawn from the upper-tier biotechs. It was held back by the inability to manufacture a chemically-modified IVT template at scale. Our PcrV linearDNA platform solves this issue and unlocks the full value of the Spindle Biotech. As Jim noted, acquiring Spindle and launching the LineaIVT platform expands our mRNA related total addressable market. On a stand-alone basis, Our linearDNA IVT templates are relevant to approximately 5% of the mRNA manufactured balance sheet.

收購時，Spindle 尚未商業化，但已經吸引了一批來自高端生物技術公司的令人羨慕的合作夥伴。由於無法大規模生產化學修飾的 IVT 模板，該計劃受到了阻礙。我們的 PcrV LinearDNA 平台解決了這個問題並釋放了 Spindle Biotech 的全部價值。正如 Jim 指出的那樣，收購 Spindle 並推出 LineaIVT 平台擴大了我們與 mRNA 相關的總體潛在市場。就獨立而言，我們的線性 DNA IVT 模板與約 5% 的 mRNA 製造資產負債表相關。

And only a limited amount of DNA template has required a very large amount of mRNA. With the ability to now sell paired IVT templates with the Spindle RNAP under the LineaIVT platform, we expect to have relevance over 20% of the mRNA manufacturing value chain, representing approximately 4x increase in the company's mRNA related total addressable market.

而且只需要有限數量的 DNA 模板就需要非常大量的 mRNA。現在能夠在 LineaIVT 平台下銷售帶有 Spindle RNAP 的配對 IVT 模板，我們預計將擁有超過 20% 的 mRNA 製造價值鏈，這意味著該公司的 mRNA 相關總可尋址市場增長了約 4 倍。

As I noted, our newly launched LineaIVT platform addresses two key pain points in interventional mRNA manufacturing: avoiding use of the plasmid DNA IVT template and minimizing DS RNA contamination, all while also providing simplified workflow. The top of slide 9, which is the current slide, represents a conventional mRNA production workflow that utilizes plasmid DNA and conventional wild-type T7 RNA type. The bottom of that slide represents a potential LineaIVT mRNA production workflow using both chemically modified LinearDNA IVT template and the Spindle RNAP. I will highlight two important differences between these both.

正如我所指出的，我們新推出的 LineaIVT 平台解決了介入 mRNA 製造中的兩個關鍵痛點：避免使用質粒 DNA IVT 模板並最大限度地減少 DS RNA 污染，同時還提供簡化的工作流程。第 9 張幻燈片（即當前幻燈片）的頂部代表了利用質粒 DNA 和傳統野生型 T7 RNA 類型的傳統 mRNA 生產工作流程。該幻燈片的底部代表了使用化學修飾的 LinearDNA IVT 模板和 Spindle RNAP 的潛在 LineaIVT mRNA 生產工作流程。我將強調兩者之間的兩個重要區別。

The first difference is the simplification of the front end that the mRNA manufacturing process. The use of pDNA or plasmid DNA as a template causes long lead time to required numerous steps and costs specific to (inaudible) [including enzymatically spread] increased regulatory scrutiny and additional filtration steps.

第一個區別是 mRNA 製造過程前端的簡化。使用 pDNA 或質粒 DNA 作為模板會導致交貨時間較長，需要大量步驟和成本（聽不清）[包括酶促擴散]增加的監管審查和額外的過濾步驟。

By replacing plasmid DNA with linearDNA in the bottom of workflow, these upstream plasmid related pain points are removed, resulting in a simpler mRNA workflow. We estimate that using linearDNA to remove that 40% of the upstream steps involved in conventional plasmid-based (inaudible), which is the top workflow.

通過在工作流程底部用線性 DNA 替換質粒 DNA，消除了這些上游質粒相關的痛點，從而使 mRNA 工作流程更加簡單。我們估計，使用線性 DNA 可以消除傳統基於質粒的（聽不清）涉及的 40% 上游步驟，這是頂級工作流程。

Second difference is in the streamlining of the back end of the mRNA manufacturing process by reducing DS RNA contamination through the unique combination of chemically modified Linea template and the Spindle RNAP. DS RNA contamination is a byproduct of wild-type T7 RNAP used in all mRNA manufacturing. T7 is used throughout the mRNA industry due to its ability to create large amounts of RNA from a small amount of DNA template. So there are trade-offs, including these production of problematic DS RNA. DS RNA is a stimulatory and inflammatory byproduct that needs to be removed for mRNA, which is a single turn of construct, before it can be used as therapeutic.

第二個區別是通過化學修飾的 Linea 模板和 Spindle RNAP 的獨特組合減少 DS RNA 污染，從而簡化了 mRNA 製造過程的後端。 DS RNA 污染是所有 mRNA 製造中使用的野生型 T7 RNAP 的副產品。由於 T7 能夠從少量 DNA 模板產生大量 RNA，因此在整個 mRNA 行業得到廣泛使用。因此需要權衡，包括產生有問題的 DS RNA。 DS RNA 是一種刺激性和炎症性副產物，需要將其去除為 mRNA（單輪構建體），然後才能用於治療。

Currently, DS RNA is removed via the expensive and complex downstream purification methods. Due to the ability of our LineaIVT platform to significantly reduce DS RNA contamination without sacrificing mRNA yield, we believe the need for downstream purification will be reduced and thus further streamlining the mRNA workflow for our customers.

目前，DS RNA 是通過昂貴且複雜的下游純化方法去除的。由於我們的 LineaIVT 平台能夠在不犧牲 mRNA 產量的情況下顯著減少 DS RNA 污染，我們相信下游純化的需求將會減少，從而進一步簡化客戶的 mRNA 工作流程。

Through some by simplifying both the upstream and downstream aspect of the mRNA production, we believe our LineaIVT platform can enable our customers to be better organized with reduced workflows with reduced portable steps and timelines.

通過簡化 mRNA 生產的上游和下游方面，我們相信我們的 LineaIVT 平台可以使我們的客戶更好地組織起來，減少工作流程，減少可移植步驟和時間表。

Now shortly after we acquired Spindle, we attended a key industry conference in Boston. The reception to our new platform is very encouraging. The plasmid DNA and DS RNA contaminations pain points addressed by our IVT Platform are fully across the industry. And it's clear that manufacturers and developers are seeking new and differentiated approaches to mRNA production.

在我們收購 Spindle 後不久，我們參加了在波士頓舉行的一次重要行業會議。我們的新平台受到的歡迎非常令人鼓舞。我們的 IVT 平台解決了整個行業的質粒 DNA 和 DS RNA 污染痛點。很明顯，製造商和開發商正在尋求新的、差異化的 mRNA 生產方法。

Equally encouraging is that our mRNA initiatives are gaining strong traction in news. We are today in use of the higher number of valuation customers since the launch or IVT template one year ago. These customers range from preclinical mRNA therapy developers to CDMOs to large therapy developers pursuing mRNA vaccines for common respiratory illness.

同樣令人鼓舞的是，我們的 mRNA 計劃在新聞中獲得了強烈關注。自一年前推出 IVT 模板以來，我們今天使用的評估客戶數量較多。這些客戶包括臨床前 mRNA 療法開發商、CDMO，以及針對常見呼吸道疾病開發 mRNA 疫苗的大型療法開發商。

Our future plans CGMP quality production capabilities are critical to converting these customers from the evaluation stage for large-scale supply agreements, and we remain committed to launching the capability by early calendar year 2024.

我們的未來計劃 CGMP 質量生產能力對於將這些客戶從評估階段轉變為大規模供應協議至關重要，我們仍然致力於在 2024 年初推出該能力。

Looking ahead, our business development efforts are focused on further elevating our profile in the marketplace and building a broader base of interest on the LineaIVT platform. Our efforts will also center around continued optimization of the platform for both conventional mRNA products as well as a growing number of self-amplifying or SA mRNA therapies. At the same time, we are hard at work at FDD or sales and marketing materials to highlight the LineaIVT platform to new (inaudible) customers.

展望未來，我們的業務發展工作重點是進一步提升我們在市場中的形象，並在 LineaIVT 平台上建立更廣泛的興趣基礎。我們的努力還將圍繞傳統 mRNA 產品以及越來越多的自我擴增或 SA mRNA 療法的平台的持續優化。與此同時，我們正在努力製作 FDD 或銷售和營銷材料，以向新（聽不清）客戶強調 LineaIVT 平台。

Finally, we remain committed to building our patent estate around our Linea RX products and services. The acquisition of Spindle brought with it a large portfolio of pending US and international patent applications covering the enzyme as well as various other modalities of next-generation R&D production. In addition, the company continues to pursue patent protection around both its linearDNA, and its LineaIVT platforms.

最後，我們仍然致力於圍繞 Linea RX 產品和服務建立我們的專利資產。收購 Spindle 帶來了大量正在申請的美國和國際專利申請，涵蓋酶以及下一代研發生產的各種其他模式。此外，該公司繼續圍繞其 LinearDNA 和 LineaIVT 平台尋求專利保護。

Now let me turn the call back to Jim for further details.

現在讓我把電話轉回吉姆以了解更多詳細信息。

Well, thank you, Clay. I'll now address the opportunities to drive revenue growth, in addition to LineaIVT. Beyond messenger RNA and central to our long-term vision for our linearDNA platform, is the ability to support the manufacture of a host of genetic medicines currently subject to the drawbacks of plasmid DNA. Recent work conducted in collaboration with our partners demonstrated safety and immunogenicity of an LNP that is a lipid nanoparticle encapsulated linearDNA vaccine candidate in mouse models.

好吧，謝謝你，克萊。除了 LineaIVT 之外，我現在將討論推動收入增長的機會。除了信使 RNA 之外，我們線性 DNA 平台長期願景的核心是能夠支持目前受到質粒 DNA 缺點影響的大量基因藥物的製造。最近與我們的合作夥伴合作進行的工作證明了 LNP 的安全性和免疫原性，LNP 是一種脂質納米顆粒封裝的線性 DNA 候選疫苗，在小鼠模型中具有安全性和免疫原性。

Our approach combines the rapid design and manufacturing capabilities akin to mRNA therapies with the thermal stability and relative manufacturing simplicity of linearDNA for a potential new class of veterinary and human health therapeutics.

我們的方法將類似於 mRNA 療法的快速設計和製造能力與線性 DNA 的熱穩定性和相對製造簡單性結合起來，用於潛在的新型獸醫和人類健康療法。

With this in mind, we expect to announce soon the establishment of a sponsored research agreement with a prestigious institution of veterinary medicine to accelerate the development of linearDNA-based vaccine platform, targeting diseases that impact high value animals. Our long-term road map for our linearDNA platform includes developing and out-licensing veterinary therapeutics. Our approach to veterinary therapeutics leverages many developments necessary for mRNA production and supports our human health aspirations.

考慮到這一點，我們預計很快就會宣布與一家著名獸醫機構建立贊助研究協議，以加速基於線性 DNA 的疫苗平台的開發，針對影響高價值動物的疾病。我們的線性 DNA 平台的長期路線圖包括開發獸醫療法並授予其許可。我們的獸醫治療方法利用了 mRNA 生產所需的許多進展，並支持我們人類健康的願望。

In addition to the opportunities discussed already, our business segments have had other exciting developments. During the fiscal third quarter, we delivered the last shipment under our largest linearDNA contract today. For context, this slide represents multiple shipments of the prior three quarters for a single amplicon utilized as a control in one diagnostic assay. The dollar values of these shipments have tripled over the time as the customers progress their assays through validation to commercial readiness. The assay is today in the early stages of the customer's commercial rollout. And as the assay is adopted, we would expect recurring orders. This customer is also developing two additional linearDNA dependent assays. We expect this customer's demand for linearDNA will grow as they validate and commercialize these other assays.

除了已經討論的機會之外，我們的業務部門還取得了其他令人興奮的發展。在第三財季，我們今天根據最大的線性 DNA 合同交付了最後一批貨物。就上下文而言，這張幻燈片代表了在一次診斷測定中用作對照的單個擴增子的前三個季度的多次發貨。隨著客戶的檢測進展到商業準備就緒的驗證，這些貨物的美元價值隨著時間的推移增加了兩倍。該檢測目前正處於客戶商業推廣的早期階段。隨著檢測的採用，我們預計會出現重複訂單。該客戶還正在開發兩種額外的線性 DNA 依賴性測定。我們預計，隨著這些其他檢測方法的驗證和商業化，該客戶對線性 DNA 的需求將會增長。

LinearDNA is also being evaluated for other diagnostic use cases, including in an assay to test for the presence of heavy metals in water and another by a leading biotech company and a quality control assay for a cutting-edge therapeutics.

LinearDNA 還正在針對其他診斷用例進行評估，包括測試水中是否存在重金屬的測定、領先生物技術公司的另一項測定以及尖端療法的質量控制測定。

These latter two opportunities are in the early stages, but they are identical to that first application I described from a production perspective. Now, we are awaiting the New York State Department of Health approval of our pharmacogenomics assay. Meanwhile, we've been actively building our go to market plan and awareness for our company and our PGX platform within the segment of potential institutional users and partners.

後兩個機會還處於早期階段，但它們與我從生產角度描述的第一個應用程序相同。現在，我們正在等待紐約州衛生部批准我們的藥物基因組學檢測。與此同時，我們一直在潛在機構用戶和合作夥伴領域積極制定我們的市場計劃和我們公司和 PGX 平台的知名度。

Now turning to our supply chain traceability business. As the industry continues to adjust to the UFLP Act compliance requirements, we are seeing ongoing demand for our source verification tools and steady growth in the associated revenues. Since the launch of our textile verification service, we have added over 50 new customers. As discussed on prior calls, the value of source verification customers is as an initial customer base within which we can expand our offering to include complementary DNA tagging and genotyping at potentially higher margins represented on this slide.

現在轉向我們的供應鏈追溯業務。隨著行業不斷調整以適應 UFLP 法案合規要求，我們看到對源驗證工具的持續需求以及相關收入的穩定增長。自推出紡織品驗證服務以來，我們已經增加了 50 多個新客戶。正如之前電話中所討論的，來源驗證客戶的價值是作為一個初始客戶群，我們可以在其中擴展我們的產品，以包括補充DNA 標記和基因分型，從而獲得本幻燈片所示的潛在更高利潤。

Discussions are ongoing with current source verification customers potentially migrating to DNA tagging and to new and existing DNA tagging prospects that in the aggregate represent potential revenue opportunities of millions of dollars. This extends not only to US brands and retailers, but also to overseas manufacturers with supply chains that extend into India and Pakistan.

目前正在與可能遷移到 DNA 標記的當前源驗證客戶以及新的和現有的 DNA 標記前景進行討論，這些前景總體上代表了數百萬美元的潛在收入機會。這不僅適用於美國品牌和零售商，還適用於供應鏈延伸至印度和巴基斯坦的海外製造商。

Before opening the call to questions, let me briefly recap some key points that we've made today. The combination of Spindle Biotech's proprietary RNA polymerase with our linearDNA IVT templates significantly increases the commercial relevance of our integrated offering to mRNA manufacturers and developers. The acquisition also positions us to monetize a much larger segment of the mRNA value chain, significantly increasing our total addressable market.

在開始提問之前，讓我簡要回顧一下我們今天提出的一些要點。 Spindle Biotech 專有的 RNA 聚合酶與我們的線性 DNA IVT 模板的結合顯著提高了我們集成產品與 mRNA 製造商和開發商的商業相關性。此次收購還使我們能夠將 mRNA 價值鏈的更大部分貨幣化，從而顯著增加我們的總目標市場。

The industry's reception to the acquisition has been positive and is helping us to advance discussions with existing evaluation customers while also attracting new prospective evaluation customers. We remain committed to delivering CGMT quality linearDNA at volumes suitable for IVT use in clinical stages and commercial launch in early calendar 2024.

業界對此次收購的反應是積極的，這有助於我們推進與現有評估客戶的討論，同時吸引新的潛在評估客戶。我們仍然致力於提供適合臨床階段 IVT 使用的 CGMT 品質線性 DNA，並於 2024 年初進行商業發布。

We continue to advance the work necessary to position our linearDNA platform for the manufacture of next-generation genetic medicines. Our ability to deliver linearDNA for diagnostic applications gives us a path to incremental revenue opportunities. We continue to see momentum in acquiring certainty source verification customers, and we're starting to engage in discussions for DNA tagging opportunities.

我們繼續推進必要的工作，將我們的線性 DNA 平台定位於下一代基因藥物的製造。我們為診斷應用提供線性 DNA 的能力為我們提供了一條增加收入機會的途徑。我們繼續看到獲得確定性來源驗證客戶的勢頭，並且我們開始參與 DNA 標記機會的討論。

Operator, this concludes my prepared remarks. Will you please open the call to questions?

接線員，我準備好的發言到此結束。請您打開提問電話好嗎？

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

我們現在開始問答環節。 （操作員說明）

Jason McCarthy, Maxim Group.

傑森·麥卡錫，馬克西姆集團。

Hey, team. Thanks for taking the questions. I just had a couple related to LineaIVT. Can you guys talk a little bit about how pretty much T7 RNAP is baked into the process, everybody uses it. So it's not so exotic. Is very common, which is good for what you're doing, and how having the fusion protein with the DNA binding domain can separate out from regular T7 is. I don't know if I'm phrasing that correctly, but how is -- I guess what I'm asking is, how easier is to make that switch for an end user of your product?

嘿，團隊。感謝您提出問題。我剛剛收到了一些與 LineaIVT 相關的信息。你們能談談這個過程中有多少 T7 RNAP 被納入其中，每個人都使用它。所以它並不那麼異國情調。很常見，這對您正在做的事情有好處，以及如何將帶有 DNA 結合域的融合蛋白與常規 T7 區分開來。我不知道我的措辭是否正確，但我想我要問的是，為產品的最終用戶進行這種切換有多容易？

Sure. That's a great question, Jason. Thank you. The workflow process for both our fusion protein and for the wild-type T7 are virtually the same. So in terms of the burden on an existing mRNA manufacturer, we feel there really is none. However, we shorten the workflow process at the beginning of the process and also at the end, and build as a consequence, in significant efficiency and the associated savings.

當然。這是一個很好的問題，傑森。謝謝。我們的融合蛋白和野生型 T7 的工作流程實際上是相同的。因此，就現有 mRNA 製造商的負擔而言，我們認為確實沒有負擔。然而，我們在流程開始和結束時縮短了工作流程，從而顯著提高了效率並節省了相關費用。

Perhaps, more important, is the fact that the wild-type T7 as part of its processivity forms double-stranded RNA, which can have a very detrimental effect when delivered. That is, it's both highly immunogenic, meaning that by the second time you use it, you could be allergic to it. And secondly, it's very inflammatory. So with little effort, we believe that the use of our platform can provide significant gain in value.

或許，更重要的是，野生型 T7 作為其持續合成能力的一部分，會形成雙鏈 RNA，這在傳遞時可能會產生非常有害的影響。也就是說，它都具有高度免疫原性，這意味著當您第二次使用它時，您可能會對它過敏。其次，它非常具有炎症性。因此，我們相信，只需付出很少的努力，使用我們的平台就可以帶來顯著的價值收益。

Clay, would you like to add anything to that?

克萊，你想補充什麼嗎？

I think that was a great answer, Jim. The platform was built into essentially be plug and play into existing plasma-based workflows. So as Jim noted, in case our upstream downstream process steps, but because of the way that the Spindle RNAP interact with our chemically modified linearDNA template, it allows us to bolster the offer conditions of the IVT reaction in a way that wild-type T7 -- would actually inhibitory to wild-type T7, and that would allow us to greatly mitigate or to a certain extent, eliminate DS RNA.

我認為這是一個很好的答案，吉姆。該平臺本質上是即插即用到現有的基於等離子體的工作流程中。因此，正如 Jim 指出的，如果我們的上游下游工藝步驟，但由於紡錘體 RNAP 與我們化學修飾的線性 DNA 模板相互作用的方式，它使我們能夠以野生型 T7 的方式支持 IVT 反應的條件。 — —實際上會抑制野生型T7，這將使我們能夠大大減輕或在一定程度上消除DS RNA。

Got it. And now I'm just going to ask one more. It's a two-part question and then I'll jump back into the queue. So Clay, you'd mentioned there's about 350 mRNA-based therapies in preclinical or clinical development. At any point along that process from a regulatory perspective, can a drug developer, an mRNA developer make the switch to LineaIVT from whatever else that they're using conventionally, that's one part.

知道了。現在我只想再問一個問題。這是一個由兩部分組成的問題，然後我將跳回到隊列中。 Clay，您提到大約有 350 種基於 mRNA 的療法處於臨床前或臨床開發中。從監管角度來看，在這一過程中的任何時刻，藥物開發商、mRNA 開發商是否可以從他們傳統使用的任何其他產品轉向 LineaIVT，這只是一部分。

And the other part is, from a simple way to just plug and play to your point, does it make it much more attractive for contract manufacturers who are probably all lining up and competing with each other. And they're not that different from each other for a contract for like Moderna's vaccine for COVID or something else. Does this product, LineaIVT really separate these contract manufacturers from one another? And is that a market that you're targeting?

另一部分是，從一種簡單的即插即用方式到你的觀點，這是否會讓它對合同製造商更具吸引力，因為他們可能都在排隊並相互競爭。對於 Moderna 的新冠疫苗或其他產品的合同來說，它們之間並沒有太大的不同。 LineaIVT 這個產品真的能夠將這些合同製造商彼此分開嗎？這是您的目標市場嗎？

(multiple speakers) Sure, go ahead, Jim.

（多個發言者）當然，請繼續，吉姆。

I'll jump into the second question and leave the first question for you. How's that?

我將直接進入第二個問題，並將第一個問題留給您。怎麼樣？

So, Jason, we believe that this is a great way for a CDMO to compete in a crowded unicolor marketplace. So that offering our platform in a license agreement to a CDMO gives us the opportunity to spread the effect to the benefit to their customers as well.

所以，Jason，我們相信這是 CDMO 在擁擠的單色市場中競爭的好方法。因此，通過向 CDMO 提供許可協議來提供我們的平台，使我們有機會將其效果傳播到他們的客戶身上，從而為他們帶來好處。

And Clay, would you like to speak to the first one?

克萊，你想和第一個人談談嗎？

Sure, yeah. So to your question of it being plug and play, how much of it possible actually that is, when we built the LineaIVT platform, we had a couple of options. And we could have really turned IVT on its head with some of the capability that the Spindle concept can do and some of the IP that it had in progress, we could've really built an IVT version 2.0, but we chose not to do that. Because there's a huge existing CDMO market out there, as you noted, and we wanted it to be plug-and-play.

當然，是的。因此，對於您關於即插即用的問題，實際上有多少可能，當我們構建 LineaIVT 平台時，我們有幾個選擇。我們本可以真正利用 Spindle 概念可以實現的一些功能以及它正在開發的一些 IP 來徹底顛覆 IVT，我們本可以真正構建 IVT 2.0 版本，但我們選擇不這樣做。因為正如您所指出的，現有的 CDMO 市場巨大，我們希望它是即插即用的。

So using the concept of this lock and key mechanism of action of Spindle plus linearDNA, we kind of built the version 1.5, we're plugged into these existing fast pace IV team manufacturing workflows. And I think that's the advantage to existing manufacturers. But down the line, we do see some pretty exotic things that you can do with chemically modifying DNA -- having binding domains on the enzyme that can be used in maybe a new form of IVT. But that is down the line..

因此，利用 Spindle 加上線性 DNA 的鎖和鑰匙作用機制的概念，我們構建了 1.5 版本，我們將其插入到這些現有的快節奏 IV 團隊製造工作流程中。我認為這就是現有製造商的優勢。但最終，我們確實看到了一些非常奇特的事情，你可以通過化學修飾 DNA 來實現——在酶上具有結合域，可以用於一種新形式的 IVT。但這是下線..

Great. Thank you, fellas.

偉大的。謝謝你們，伙計們。

Okay. Thank you, Jason.

好的。謝謝你，傑森。

(Operator Instructions) Yi Chen, H.C. Wainwright.

（操作員指令） Yi Chen, H.C.溫賴特。

Hey everyone. This is Chait, on behalf of Yi Chen. And my apologies, my signal was bad. So if you've already answered these questions, please excuse me. But could you comment on the types of customers you're attracting with respect to the certainty authenticity platform? I know you indicated that you have over 50 customers added. So are these textile and manufacturing customers across the world? Any color on that would be very helpful, and also your take on its potential in the future from a revenue standpoint. Thank you so much.

嘿大家。我是 Chait，代表以晨。抱歉，我的信號不好。如果您已經回答了這些問題，請原諒。但您能否評論一下您通過確定性真實性平台吸引的客戶類型？我知道您表示已添加了 50 多個客戶。那麼這些紡織和製造業客戶遍布世界各地嗎？任何顏色都會非常有幫助，而且你從收入的角度來看它未來的潛力。太感謝了。

Sure. Happy to. So our technology is relevant to every node in the supply chain. And every node is impacted by the weaker forced Labor Protection Act. So even if you consider starting at the level of the farm, the veiled cotton needs to be able to prove its origin all the way through the supply chain or when it's deveiled at the spinner.

當然。高興。因此，我們的技術與供應鏈中的每個節點相關。而每個節點都受到較弱的強制勞動保護法的影響。因此，即使您考慮從農場層面開始，遮蓋棉花也需要能夠在整個供應鏈中或在紡紗廠遮蓋時證明其來源。

So we're seeing request from every element of the supply chain. From the farm, to the spinner, to the weaver, to the cut and sew operation, to the brand owner to the retailer. Each one has to be concerned with whether or not they can prove that their product is made without the benefit of forced labor.

因此，我們看到了供應鏈各個環節的需求。從農場，到紡紗廠，到織布廠，到裁剪和縫紉操作，到品牌所有者到零售商。每個人都必須關心他們是否能夠證明他們的產品是在沒有強迫勞動的情況下製造的。

So not only are we seeing it integrated across every node of the supply chain, but we're seeing it effectively relevant across the entire world for the most part. So we have exciting new opportunities in India and Pakistan. We've got a long-standing business dealing with American cotton. And so this platform is of certainties helping us become relevant to a global enterprise.

因此，我們不僅看到它集成到供應鏈的每個節點，而且我們看到它在很大程度上與整個世界有效相關。因此，我們在印度和巴基斯坦擁有令人興奮的新機遇。我們與美國棉花有長期業務往來。因此，這個平台肯定會幫助我們與全球企業產生聯繫。

Does that answer your question?

這是否回答你的問題？

It did. Thank you so much. And one quick one on linearity and then -- my apologies if I missed it earlier on. But where are you with in terms of discussions with the prospective evaluation customers? Any color on the nature of discussions at this stage would be very helpful. Thank you so much.

它做了。太感謝了。快速介紹一下線性度，然後——如果我之前錯過了，我深表歉意。但是，您在與潛在評估客戶的討論方面處於什麼位置？任何關於現階段討論性質的顏色都會非常有幫助。太感謝了。

Clay, would you like to handle that one?

克萊，你願意處理那個嗎？

Yeah, sure. So we launched the linearDNA IVT templates about one year ago, right? And that is our enzymatically produced templating service. About one month ago, we launched LineaIVT platform, which is the integration of the linearDNA templates, right with this in the lab. We have a good number of evaluation customers, really running the gamut from preclinical start-up biotech to CDMO to large pharma looking at our linearDNA template.

好，當然。所以我們大約在一年前推出了 LinearDNA IVT 模板，對吧？這就是我們的酶法生產的模板服務。大約一個月前，我們推出了 LineaIVT 平台，它是線性 DNA 模板的集成，就在實驗室中。我們擁有大量的評估客戶，從臨床前初創生物技術到 CDMO，再到大型製藥公司，他們都在研究我們的線性 DNA 模板。

We have a fair amount of interest within our existing evaluation customers for the LineaIVT platform, which just launched last month. So our commercialization strategy is to leverage our existing relationships with the strong contacts in biotech and pharma for our templates to get them to evaluate many IVT platforms. In addition, we have, since it launched last month, is there a conference two weeks ago, we do have a fair amount of new contacts that wish to evaluate the LineaIVT platform exclusively. And we're seeing that mainly in the CDMO space as a way to really mitigate against the SRNA. And we're seeing a lot of interest in the platform for the potential manufacturer of self-amplifying mRNA.

我們現有的評估客戶對上個月剛剛推出的 LineaIVT 平台非常感興趣。因此，我們的商業化策略是利用我們與生物技術和製藥領域的強大聯繫的現有關係作為我們的模板，讓他們評估許多 IVT 平台。此外，自從上個月推出以來，兩週前有一次會議，我們確實有相當多的新聯繫人希望專門評估 LineaIVT 平台。我們認為這主要是在 CDMO 領域，作為真正緩解 SRNA 影響的一種方式。我們看到許多潛在的自擴增 mRNA 製造商對該平台產生了濃厚的興趣。

That seems to be where the industry is going. And there are substantial manufacturing challenges with SA mRNA, and we do believe this platform can address many of them.

這似乎就是這個行業的發展方向。 SA mRNA 存在巨大的製造挑戰，我們相信這個平台可以解決其中的許多挑戰。

Excellent. Thank you so much.

出色的。太感謝了。

(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。

Thank you so much.

太感謝了。

Well, thank you all for joining us today. Before I conclude the call, I'd like to take an opportunity to say on behalf of all of Applied DNA, that we were privileged to assist the City University of New York in keeping their communities safe, which was really a success, as judged, both by the note of gratitude we receive from the administration, including Hector Batista, the executive Chancellor -- Vice Chancellor and COO, who stated: your tools and practical solutions empowered the university with real-time data to make informed decisions that in turn, kept our community safe from the beginning of the pandemic. We recognize the importance of following the science and Applied DNA was instrumental to helping us uphold that principle.

好的，謝謝大家今天加入我們。在結束通話之前，我想藉此機會代表 Applied DNA 的全體人員表示，我們很榮幸能夠協助紐約市立大學確保其社區的安全，正如我們所評價的那樣，這確實是一次成功，我們收到了來自行政部門的感謝信，其中包括執行校長兼首席運營官赫克托·巴蒂斯塔(Hector Batista)，他表示：你們的工具和實用解決方案使大學能夠利用實時數據做出明智的決策，從而反過來，從大流行開始就保證了我們社區的安全。我們認識到遵循科學的重要性，而 Applied DNA 有助於幫助我們堅持這一原則。

But it's also noteworthy to recognize that throughout the course of our contract, CUNY positivity rates remained at a fraction of the surrounding boroughs.

但同樣值得注意的是，在我們的合同期內，紐約市立大學的陽性率仍只佔周邊行政區的一小部分。

Well, thank you again, and we look forward to updating you on our progress on our fiscal fourth quarter and year end. Thank you very much, and have a good evening.

好吧，再次感謝您，我們期待向您通報我們第四財季和年底的最新進展。非常感謝，祝您晚上愉快。

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。您現在可以斷開連接。