BNB Plus Corp (BNBX) 2024 Q3 法說會逐字稿

Good day and welcome to the Applied DNA fiscal third quarter 2024 investor 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 2024 年第三季投資者電話會議。（操作員說明）請注意此事件正在被記錄。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, Cindy. Good afternoon, everyone, and welcome to Applied DNA's conference call to discuss our third quarter fiscal 2024 financial results. Can access the press release that was issued after market close today as well as the slide presentation accompanying this call on the Investor Relations section of our corporate website or via the webcast today.

謝謝你，辛蒂。大家下午好，歡迎參加 Applied DNA 的電話會議，討論我們 2024 財年第三季的財務表現。您可以在我們公司網站的投資者關係部分或透過今天的網路廣播訪問今天收盤後發布的新聞稿以及本次電話會議隨附的幻燈片演示。

Speaking on the call 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 this call.

我們的董事長、總裁兼執行長 James Hayward 博士在電話會議上發言。 Beth Jantzen，我們的財務長；以及我們的首席法務官兼業務開發主管 Clay Shorrock；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 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，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結果存在重大差異的重要風險因素。我們不承擔因新資訊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資訊的義務。

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

現在我很高興在今天的電話會議上介紹我們的第一位發言人。貝絲詹特森，請繼續。貝絲。

Thank you, Sanjay. Good afternoon, everyone, and thank you for joining us on our third quarter fiscal 2024 investor call. I will start this afternoon with an overview of our results for the quarter ended June 30, 2024. I will then turn the call over to Dr. James Hayward and Clay Shorrock, 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 財年第三季投資人電話會議。我將從今天下午開始概述我們截至 2024 年 6 月 30 日的季度業績。然後我會將電話轉給 James Hayward 博士和 Clay Shorrock，他們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。

Prefacing my review of our financial results for the quarter, our year-over-year comparison reflects the June 2023 quarter, which included revenues and costs associated with our COVID surveillance testing for CUNY. That contract concluded in June 2023.

在我對本季度財務表現的回顧之前，我們的同比比較反映了 2023 年 6 月的季度，其中包括與紐約市立大學的新冠病毒監測測試相關的收入和成本。該合約於 2023 年 6 月簽訂。

Beginning with our statement of operations, total revenues for the third quarter of fiscal '24, which ended on June 30 were approximately $798,000 or a decline of $2.1 million compared to $2.9 million for the same period in the prior fiscal year. The majority of the year-over-year decline in total revenue was from a decrease in our clinical laboratory service revenues of $1.85 million, which relates to the aforementioned COVID surveillance testing contract for CUNY, which is included in our June 2023 financial results.

從我們的營運報表開始，截至 6 月 30 日的 24 財年第三季總收入約為 798,000 美元，比上一財年同期的 290 萬美元減少了 210 萬美元。總收入年減的主要原因是我們的臨床實驗室服務收入減少了 185 萬美元，這與上述紐約市立大學的新冠病毒監測測試合約有關，該合約已包含在我們 2023 年 6 月的財務業績中。

Approximately $70,000 of the decrease in total revenue is attributable to lower product revenues and specifically to decreases in shipments for consumer asset marketing and from a nutraceutical customer, both within our DNA tagging and Security Products and Services segment. Service revenues decreased by approximately $200,000 year-over-year. This decrease is attributable to a decrease in R&D projects and our therapeutic DNA Production Services segment as well as to isotopic testing within our DNA tagging and Security Products and Services segment.

總收入減少約 70,000 美元，歸因於產品收入下降，特別是我們的 DNA 標籤以及安全產品和服務部門內的消費者資產行銷和營養保健品客戶的發貨量減少。服務收入較去年同期減少約20萬美元。這項減少歸因於研發項目和治療性 DNA 生產服務部門以及 DNA 標籤和安全產品和服務部門內同位素測試的減少。

Gross profit was $245,000 or 31% as compared to $1.3 million or 44% in the prior fiscal year period. The decrease in gross profit was primarily due to a decline in gross profit for our NDX Testing Services segment, specifically related to significantly decreased COVID-19 testing volumes year-over-year. Total operating expenses decreased by approximately $500,000 to $3.6 million compared to $4.1 million in the prior fiscal year period.

毛利為 245,000 美元，即 31%，而上一財年期間的毛利為 130 萬美元，即 44%。毛利下降主要是由於我們的 NDX 測試服務部門毛利下降，特別是與 COVID-19 檢測量同比大幅下降有關。與上一財年期間的 410 萬美元相比，總營運費用減少了約 50 萬美元，降至 360 萬美元。

The decrease in total operating expenses reflects lower SG&A, which is attributable to a reduction in stock-based compensation expense related to the annual option grant to nonemployee members of our Board and RSUs to officers as well as the elimination of certain consultants, which together totaled approximately $500,000.

總營運費用的減少反映出 SG&A 的減少，這是由於與向董事會非僱員成員授予年度期權和向管理人員授予 RSU 相關的股票薪酬費用減少以及某些顧問的取消所致，這些費用總計大約50萬美元。

The decrease in SG&A was offset by an increase in R&D of approximately $77,000 to $913,000 from $836,000 in the year ago period. This increase relates to the development of a commercial quantity of our Linea RNA polymerase used by our Linea IVT platform and for consultants to further optimize the RNA polymerase acquired from the Spindle acquisition. Our operating loss for the third quarter was $3.3 million compared to $2.9 million in the prior fiscal period.

SG&A 的減少被研發支出從去年同期的 836,000 美元增加約 77,000 美元至 913,000 美元所抵消。這一增長與我們的 Linea IVT 平台所使用的商業數量的 Linea RNA 聚合酶的開發有關，以及顧問進一步優化從 Spindle 收購中獲得的 RNA 聚合酶。我們第三季的營運虧損為 330 萬美元，而上一財年的營運虧損為 290 萬美元。

Turning to slide 5, excluding noncash expenses, adjusted EBITDA decreased by $1.1 million to negative $3.2 million compared to a negative $2.1 million in the prior fiscal year period. Now turning to our balance sheet on slide 6. Cash and cash equivalents totaled $10.4 million on June 30 compared to $7.2 million on September 30, 2023. The June 30 cash and cash equivalents figure includes the net proceeds of $10.5 million from a public offering that closed on May 28.

轉向投影片 5，不包括非現金支出，調整後 EBITDA 減少 110 萬美元，至負 320 萬美元，而上一財政年度為負 210 萬美元。現在轉向投影片 6 上的資產負債表。截至 6 月 30 日，現金及現金等價物總額為 1,040 萬美元，而 2023 年 9 月 30 日為 720 萬美元。6 月 30 日的現金和現金等價物數據包括 5 月 28 日結束的公開發行的 1,050 萬美元淨收益。

As of June 30, accounts receivable stood at $531,000, the majority of which was collected after the quarter ended. Our average monthly cash burn is $1.2 million fiscal year-to-date compared to $500,000 in the prior year. Our average monthly cash burn for the third quarter of fiscal 2024 was $1.3 million. The increase in our cash burn during the third quarter of fiscal 2024 reflects a catch-up on payments made after the financing and the payment of professional fees related to our two finances conducted during the fiscal year.

截至 6 月 30 日，應收帳款為 531,000 美元，其中大部分在季度結束後收回。本財年迄今為止，我們的平均每月現金消耗為 120 萬美元，而前一年為 50 萬美元。2024 財年第三季我們的平均每月現金消耗為 130 萬美元。2024 財年第三季我們的現金消耗增加反映了融資後支付的款項以及與本財年進行的兩項財務相關的專業費用的支付。

I also note that our just filed Form 10-Q maintains a disclosure from our prior Form 10-Q 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. On July 31, 2024, our cash and cash equivalents were approximately $8.9 million.

我還注意到，我們剛剛提交的 10-Q 表格保留了先前 10-Q 表格中對持續經營存在重大疑問的披露。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產生收入或籌集資金的能力。截至 2024 年 7 月 31 日，我們的現金和現金等價物約為 890 萬美元。

Turning to the offering. We issued 9.23 million common shares and prefunded warrants to purchase common shares. Series A warrants to purchase 9.23 million common shares at an exercise price of $1.99 with a five year term from the shareholder approval date. We also issued Series B warrants to purchase 9.23 million common shares at an exercise price of $1.99 with a one year term from the shareholder approval date. The Series B warrants also allow for an alternative cashless exercise option in which the warrant owner receives 3 shares of common stock at a $0 exercise spread. The exercisability of both the Series A and B warrants are subject to shareholder approval.

轉向奉獻。我們發行了 923 萬股普通股和預購認股權證來購買普通股。A 系列認股權證以 1.99 美元的行使價購買 923 萬股普通股，自股東批准之日起有效期為五年。我們也發行了 B 系列認股權證，以 1.99 美元的行使價購買 923 萬股普通股，期限自股東批准之日起一年。B 系列認股權證還允許另一種無現金行使選項，其中認股權證所有者以 0 美元的行使價差獲得 3 股普通股。A系列和B系列認股權證的行使均須經股東批准。

Subject to shareholder approval, the exercise of the Series A warrants could result in additional gross proceeds of approximately $18.4 million to the company. Subject to the same approval by stockholders, the exercise of the Series B warrants could result in additional gross proceeds of approximately $18.4 million, where under the alternative cashless exercise provision, holders of the Series B warrants would receive 3 shares of common stock for every Series B warrant exercised with no gross proceeds to the company.

經股東批​​准，行使 A 系列認股權證可能會為公司帶來約 1,840 萬美元的額外總收益。在獲得股東同樣批准的情況下，B 系列認股權證的行使可能會帶來約1840 萬美元的額外總收益，根據替代性無現金行使條款，B 系列認股權證的持有人將獲得每個系列3 股普通股B 認股權證已行使，本公司未獲得任何收益。

If all of the Series A warrants are exercised and if the Series B warrants are exercised pursuant to the cashless exercise option described above, we would have 47.2 million shares of common stock outstanding. On August 2, in accordance with the terms of the public offering, we conducted a special meeting of shareholders to seek to obtain stockholder approval for the series warrants just discussed.

若所有 A 系列認股權證均已行使，且 B 系列認股權證依據上述無現金行使選項行使，我們將擁有 4,720 萬股已發行普通股。8月2日，根據公開發行條款，我們召開了特別股東大會，尋求股東對剛才討論的系列認股權證的批准。

This special meeting was adjourned due to a lack of quorum. In accordance with the terms of the public offering, we are obligated to call a subsequent stockholder meeting within 90 days from August 2, to seek to obtain approval of the exercisability of the series line. As such, the warrant stockholder approval proposal is now included in the proxy for our annual meeting of stockholders, which is scheduled for September 30. A preliminary copy of our proxy was filed with the SEC on Monday and is viewable on the EDGAR website and our IR website.

本次特別會議因未達法定人數而休會。根據公開發行條款，我們有義務在8月2日起90天內召開後續股東大會，以尋求該系列產品線行權的批准。因此，認股權證股東批准提案現已包含在我們定於 9 月 30 日舉行的年度股東大會的委託書中。我們的委託書初步副本已於週一向 SEC 提交，可在 EDGAR 網站和我們的 IR 網站上查看。

The annual meeting proxy also includes a proposal to grant the Board the authority to implement a reverse stock split to meet the minimum bid price requirement under the Nasdaq Capital Market listing rules. On July 12, we received notice from the listing qualifications department of Nasdaq notifying us that we are not in compliance with the minimum bid price requirements set forth by Nasdaq for continued listing on the Nasdaq Capital Market.

年會委託書還包括一項提議，授權董事會實施反向股票分割，以滿足納斯達克資本市場上市規則的最低投標價格要求。7月12日，我們收到納斯達克上市資格部門的通知，通知我們不符合納斯達克規定的繼續在納斯達克資本市場上市的最低投標價格要求。

The notification letter does not impact our listing on the Nasdaq Capital Market at this time. We have 180 calendar days or until January 8, 2025, to regain compliance with the minimum bid price requirement. In order to regain compliance, our bid price must close at or above $1 per share for a minimum of 10 consecutive business days.

該通知函目前不會影響我們在納斯達克資本市場的上市。我們有 180 個日曆日（即 2025 年 1 月 8 日之前）重新遵守最低投標價格要求。為了重新獲得合規性，我們的收購價必須連續至少 10 個工作天收於每股 1 美元或以上。

If we do not regain compliance with this Nasdaq listing rule by January 8, we may be eligible for an additional 180 calendar day compliance period, assuming that we are in compliance with all the other Nasdaq listing requirements. We believe that the 180-day period in which we have to cure the deficiency overlaps multiple biotherapeutics commercialization points that, in our view are value-creating.

如果我們在 1 月 8 日之前未能重新遵守納斯達克上市規則，假設我們遵守所有其他納斯達克上市要求，我們可能有資格獲得額外 180 個日曆日的合規期。我們相信，我們必須治癒缺陷的 180 天期限與多個生物治療藥物商業化點重疊，我們認為這些點是創造價值的。

In a moment, you will hear Jim and Clay deliver commentary on anticipated commercial progress that we believe will drive total revenues to an inflection point starting in the first half of fiscal '25. We consider it prudent to seek the discretion to implement a reverse stock split to maintain Applied DNA's Nasdaq listing, should the stock market not recognize the execution of our biotherapeutic-driven value creation story by the conclusion of the 180 day cure period.

稍後，您將聽到 Jim 和 Clay 對預期商業進展發表評論，我們相信這些進展將在 25 財年上半年開始推動總收入達到拐點。我們認為，如果股市在180 天治療期結束時沒有認識到我們生物治療驅動的價值創造故事的執行情況，那麼明智的做法是尋求實施反向股票分割，以維持Applied DNA 在納斯達克的上市。

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

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，徵求他的意見。吉姆？

Thank you, Beth, and good afternoon, everyone. Thank you for joining us on our third quarterly investor call of fiscal 2024. We have a great deal to update you on today across each of our three business segments. I encourage you to follow along with our slide deck that supports my remarks this afternoon. Our efforts during the third quarter and fiscal 2024 have continued a value-creation strategy that we put in place after the pandemic to leverage our expertise in the scale manufacturer and detection of DNA via PCR, and to increase the role of Linea DNA in the contemporary platforms that are driving the commercialization of new nucleic acid therapeutics and the related initiatives. All these efforts focused on the return of the company to a growth trajectory.

謝謝你，貝絲，大家午安。感謝您參加我們 2024 財年第三季投資者電話會議。今天我們有很多關於我們三個業務部門的最新消息要向您介紹。我鼓勵您關注我們的幻燈片，它支持我今天下午的言論。我們在第三季和2024 財年的努力延續了我們在疫情後實施的價值創造策略，以利用我們在規模製造和透過PCR 檢測DNA 方面的專業知識，並增強Linea DNA 在當代社會中的作用。所有這些努力都集中在公司重返成長軌道上。

We accomplished much during the third quarter, executing against our commercial road map in all business segments and supported by a strengthened balance sheet for continued operational momentum. During the quarter, we accomplished the following significant developments. We continue to build our capacity for the enzymatic GMP production of DNA IVT templates and are on track for completion of our GMP facility by September 30, our fiscal year-end.

我們在第三季度取得了巨大成就，在所有業務部門都按照我們的商業路線圖執行，並得到了強化的資產負債表的支持，以保持持續的營運勢頭。本季度，我們取得了以下重大進展。我們繼續建造 DNA IVT 模板酶促 GMP 生產能力，並預計在 9 月 30 日（我們的財政年度結束）前完成我們的 GMP 設施。

We have received full New York State Department of Health approval for a laboratory-developed test. We commercially launched TR8 PGx, our pharmacogenomic testing service. And after the close of the quarter, we entered into a multiyear agreement within this group that potentially represents a substantial expansion of our cotton tagging addressable market.

我們已獲得紐約州衛生部對實驗室開發的測試的完全批准。我們商業化推出了藥物基因組測試服務 TR8 PGx。本季結束後，我們在該集團內簽訂了一項多年期協議，這可能代表著我們棉花標籤潛在市場的大幅擴張。

These developments, we believe signal Applied DNA's post-COVID return to growth strategy as we approach commercial milestones to deliver year-over-year revenue growth starting in the first half of fiscal 2025. We believe that our return to growth will be primarily catalyzed by anticipated near-term developments at LineaRx, our biotherapeutics segment and from our DNA tagging segment with initial contributions from ADCL and its pharmacogenomic testing service.

我們相信，這些進展標誌著 Applied DNA 在新冠疫情後恢復成長策略，我們即將實現商業里程碑，從 2025 財年上半年開始實現營收年增。我們相信，我們的成長恢復將主要受到 LineaRx、我們的生物治療部門和 DNA 標籤部門的預期近期發展的推動，其中 ADCL 及其藥物基因組測試服務的初步貢獻。

Clay and I will discuss these developments in greater detail in a moment. But before that, I want to be clear, our expectation of an imminent revenue inflection should not be construed as financial guidance. We have every confidence in achieving them, but they are wholly reliant on future commercial activities that have not yet formally begun.

克萊和我稍後將更詳細地討論這些進展。但在此之前，我想澄清的是，我們對收入即將改變的預期不應被視為財務指引。我們完全有信心實現這些目標，但它們完全依賴尚未正式開始的未來商業活動。

During the third quarter, we negotiated and entered into a five year certainty commercialization agreement within this group, a key global cotton apparel manufacturer. The agreement calls for us to supply spray systems, DNA tagging, testing services for DNA tagging and genotyping, devices and materials for on-site testing and isotope testing services. When they are ready, Indus plans to take testing in-house, accelerating their service velocity.

在第三季度，我們在該集團（全球主要棉質服裝製造商）內談判並簽訂了為期五年的確定性商業化協議。該協議要求我們提供噴霧系統、DNA 標記、DNA 標記和基因分型測試服務、現場測試設備和材料以及同位素測試服務。準備好後，Indus 計劃進行內部測試，以加快服務速度。

We are awaiting receipt of an initial purchase order from Indus to support our deployment activities. In year one of the agreement, we and Indus intend to implement certainty at multiple cotton spinning mills. Indus will provide regular forecast for tagged cotton demand and a planned subsequent broader deployment across Indus' footprint will be based on their demand for tagged cotton.

我們正在等待收到 Indus 的初始採購訂單，以支援我們的部署活動。在協議的第一年，我們和 Indus 打算在多家棉紡廠實施確定性。Indus 將定期預測標籤的棉花需求，並計劃根據其對標籤棉花的需求，在 Indus 的足跡中進行後續更廣泛的部署。

And as you can see on this slide, Indus serves major apparel markets, each with regulations to ensure that our customers are not complicit in using forced or slave labor in the supply chains that end in those respective markets. The historical commitment to innovation and sustainability by Indus and its strong foothold across the apparel value chain makes it an ideal certainty partner. And while the agreement has no minimum Indus purchase commitments, we believe our new partnership within this will provide for sustainable growth in this business segment for the following reasons.

正如您在這張投影片中所看到的，Indus 為主要服裝市場提供服務，每個市場都有規定，以確保我們的客戶不會在最終到達各自市場的供應鏈中串通使用強迫或奴役勞工。Indus 對創新和永續發展的歷史承諾及其在服裝價值鏈中的強大立足點使其成為理想的確定性合作夥伴。雖然該協議沒有最低限度的 Indus 採購承諾，但我們相信，我們在該協議中的新合作夥伴關係將促進該業務領域的可持續增長，原因如下。

Indus is a leading supplier to some of the world's most renowned brands. Ours is a volume driven business and Indus uses approximately 450 million pounds of cotton annually. In an environment so influenced by the UFLPA or the Uyghur Forced Labor Prevention Act, the ability to sell UFLPA compliant apparel to customers becomes a key selling point for new customer acquisition and retention. The deployment of our CertainT platform in all aspects will enable Indus to ensure that the products they manufacture for their customers are end-market-compliant.

Indus 是一些世界最著名品牌的領先供應商。我們的業務是產量驅動型業務，Indus 每年使用約 4.5 億磅棉花。在受 UFLPA 或《維吾爾強迫勞動預防法》影響的環境中，向客戶銷售符合 UFLPA 要求的服裝的能力成為獲取和保留新客戶的關鍵賣點。我們的CertainT平台在各方面的部署將使Indus確保他們為客戶製造的產品符合終端市場的要求。

Indus maintains year-round ginning and spinning operations, allowing for a decoupling from the revenue seasonality that's been inherent to our historical focus on US Pima cotton and which drove lumpy revenues in our business segment. And finally, Indus can supply tagged cotton at volumes required by the large users of cotton in our supply in our sales pipeline. In short, we believe Indus solves the issue of tagged cotton supply that has always gated the growth of this segment.

Indus 全年保持軋棉和紡紗業務，從而擺脫了收入季節性的影響，這種季節性是我們歷史上專注於美國皮馬棉所固有的，並且導致了我們業務部門收入的波動。最後，Indus 可以按照我們銷售管道中棉花大用戶所需的數量供應帶有標籤的棉花。簡而言之，我們相信 Indus 解決了棉花供應標籤問題，該問題一直限制著該領域的成長。

Our CertainT platform enables customers to provide forensic evidence supporting [UFPLA] compliance. It is still an issue as supported by evidence in a report we published earlier this year by us and our isotope testing partner. The report indicated traces of banned Chinese cotton were found in 19% of a sample of merchandise sold at US and global retailers in the past year. Of the items that tested positive for Xinjiang cotton, 57% featured labels that claim the merchandise origin was solely in the US.

我們的 certainT 平台使客戶能夠提供支援 [UFPLA] 合規性的法醫證據。這仍然是一個問題，我們和我們的同位素測試合作夥伴在今年稍早發布的一份報告中得到了證據的支持。該報告指出，去年美國和全球零售商銷售的商品樣本中有 19% 發現了被禁用的中國棉花痕跡。在新疆棉花檢測呈陽性的商品中，57% 的商品標籤上聲稱商品原產地僅在美國。

With this as context, we continue to serve repeat customers for isotopic testing as entree to direct contact with very large cotton users, manufacturers, brands and retailers, some of whom can now be introduced doing this for a ready supply of cotton.

以此為背景，我們繼續為回頭客提供同位素測試服務，作為與大型棉花用戶、製造商、品牌和零售商直接接觸的入口，現在可以介紹其中一些人這樣做，以獲得現成的棉花供應。

Now turning to our pharmacogenomics testing service, which is branded TR8 or TR8 PGx. While awaiting the resolution of the New York State Department of Health's lengthy LDT review and approval process, we built this business for large-scale testing, reflecting our commercial aspirations for enterprise or other large population contracts. ADCL's PGx testing capacity can support up to $25 million in annual revenue today.

現在轉向我們的藥物基因組學測試服務，其品牌為 TR8 或 TR8 PGx。在等待紐約州衛生部漫長的 LDT 審查和批准程序的解決過程中，我們建立了這項大規模測試業務，反映了我們對企業或其他大量人口合約的商業願望。ADCL 的 PGx 測試能力目前可支援高達 2,500 萬美元的年收入。

Our goal with PGx testing is to avoid pricing pressures common to commoditize diagnostics. To this end, our initial sales effort is to build a demand for concierge testing before turning to the higher-volume enterprise testing. In our concierge sales model, the clinician plays a crucial role in patient uptake and will enable us to begin generating revenue while further optimizing the testing service necessary to manage the larger enterprise testing volumes.

我們 PGx 測試的目標是避免診斷商品化時常見的定價壓力。為此，我們最初的銷售工作是在轉向更高容量的企業測試之前建立禮賓測試的需求。在我們的禮賓銷售模式中，臨床醫生在患者接受方面發揮著至關重要的作用，這將使我們能夠開始創造收入，同時進一步優化管理更大的企業檢測量所需的檢測服務。

Given PGx's favorable margin profile, we expect this segment to approach profitability over the next two quarters, even at low testing volumes. From there, our testing can be scaled quickly and we expect our first enterprise testing customer to come sometime in the first half of calendar year 2025. Now before I turn the call over to Clay, who will take you through some very exciting developments in the commercialization of Linea IVT templates and our Linea IVT platform, I want to provide some context that demonstrates the speed with which the field of genetic medicines is progressing.

鑑於 PGx 有利的利潤狀況，我們預計該細分市場將在未來兩個季度實現盈利，即使測試量較低。從那時起，我們的測試可以快速擴展，我們預計我們的第一個企業測試客戶將在 2025 年上半年的某個時候到來。現在，在我將電話轉給Clay 之前，他將帶您了解Linea IVT 模板和我們的Linea IVT 平台商業化方面的一些非常令人興奮的進展，我想提供一些背景信息，以證明基因藥物領域的發展速度。

In fiscal 2022, with the biotherapeutics industry is coalescing around messenger RNA technology that was driven by the success of the COVID vaccines, we initiated sales of Linea DNA as an IVT template for mRNA production. We positioned Linea IVT templates as a differentiated approach to plasmid templated IVT mRNA.

2022 財年，隨著生物治療產業在新冠疫苗的成功推動下，生物治療產業正在圍繞信使 RNA 技術進行整合，我們開始銷售 Linea DNA，作為 mRNA 生產的 IVT 模板。我們將 Linea IVT 模板定位為質粒模板 IVT mRNA 的差異化方法。

Relative to plasmid templates, Linea IVT templates have many advantages to facilitate the broader commercialization of messenger RNA-based therapies. By fiscal 2023, we had accumulated an impressive roster of biopharma and CDMO template evaluation customers. The industry's strong interest was very clear. But our lack of GMP production capacity gated commercial adoption beyond technology evaluation projects. It also became quickly evident that while our templates have an outsized impact on messenger RNA workflows, we were leaving considerable economics on the table.

相對於質粒模板，Linea IVT 模板具有許多優勢，有助於促進基於信使 RNA 的療法更廣泛的商業化。到 2023 財年，我們已經累積了令人印象深刻的生物製藥和 CDMO 範本評估客戶名單。業界的強烈興趣非常明顯。但我們缺乏 GMP 生產能力，限制了技術評估專案以外的商業應用。人們很快就發現，雖然我們的模板對信使 RNA 工作流程有著巨大的影響，但我們卻留下了相當大的經濟效益。

In fiscal 2023, we began to solve for both those issues with the implementation of a GMP road map and with the acquisition of Spindle Biotech. Our Linea IVT platform was launched, enabling us to capture more of the messenger RNA value chain and associated greater economics. And as we approach the end of fiscal 2024, I'm pleased to report that we are on schedule for GMP startup by September 30, our fiscal year-end and have successfully completed scale-up of our Linea RNA polymerase enzyme, a critical component of our Linea IVT platform.

2023 財年，我們開始透過實施 GMP 路線圖和收購 Spindle Biotech 來解決這些問題。我們推出了 Linea IVT 平台，使我們能夠捕捉更多的信使 RNA 價值鏈以及相關的更大經濟效益。隨著2024 財年即將結束，我很高興地向大家報告，我們已按計劃於9 月30 日（本財年結束）之前啟動GMP，並成功完成了Linea RNA 聚合酶（一種關鍵成分）的規模擴大我們的 Linea IVT 平台。

I'm also happy to report that we have recently completed long-term validation studies with 2 Linea DNA template customers and we are now being onboarded as a validated GMP vendor into their workflows. We are targeting early calendar 2025 to support them with IVT templates to produce messenger RNA clinical trial materials. We are also in the late stages of evaluation with a third Linea DNA template customer and hope to be onboarded as a validated GMP vendor shortly.

我還很高興地報告，我們最近與 2 個 Linea DNA 模板客戶完成了長期驗證研究，現在我們作為經過驗證的 GMP 供應商加入他們的工作流程。我們的目標是在 2025 年初為他們提供 IVT 模板支持，以生產信使 RNA 臨床試驗材料。我們也處於與第三家 Linea DNA 模板客戶的評估後期階段，希望很快成為經過驗證的 GMP 供應商。

So this is an exciting place to be as we approach our GMP startup. And on behalf of our Board of Directors, myself, the entire management team, I'd like to personally thank the LineaRx sales and business development team for the tremendous progress to ensure the success of our biotherapeutics business.

因此，當我們著手建立 GMP 新創公司時，這是一個令人興奮的地方。我謹代表我們的董事會、我本人以及整個管理團隊，向 LineaRx 銷售和業務開發團隊表示感謝，感謝他們為確保我們的生物治療業務取得成功而取得的巨大進步。

Let me now turn the call to Clay for a deeper dive into our biotherapeutics opportunity. Clay?

現在讓我致電克萊，深入探討我們的生物治療機會。黏土？

Thank you, Jim, and good afternoon, everyone. In recent years, we've established a market footprint, demonstrated credibility and as Jim noted, have generated an annual roster of valuation customers. Last week, I attended the fourth annual mRNA therapeutics summit in Boston. This is our third consecutive year in attendance. I've been privileged to have a front row seat to our maturation from an upstart new player to an established fixture in the mRNA manufacturing industries and I echo Jim's thanks to the entire team.

謝謝吉姆，大家下午好。近年來，我們已經建立了市場足跡，展現了信譽，正如吉姆所指出的那樣，我們已經產生了年度評估客戶名冊。上週，我參加了在波士頓舉行的第四屆 mRNA 治療高峰會。這是我們連續第三年參加。我很榮幸能夠坐在前排見證我們從一個新貴新玩家成長為 mRNA 製造業的老牌企業，我也同意 Jim 對整個團隊的感謝。

The marketplace's receptivity to our Linea IVT templates and Linea IVT platform continues to be strong. Relative to conventional plasma DNA based template, we utilize an enzymatic manufacturing process to rapidly produce large quantities of high-purity DNA sequences, solving a major pain point for the mRNA industry.

市場對我們的 Linea IVT 模板和 Linea IVT 平台的接受度仍然很高。相對於傳統的血漿DNA模板，我們利用酵素製造製程快速生產大量高純度DNA序列，解決了mRNA產業的一大痛點。

With our Linea IVT platform, which combines Linea IVT templates with our proprietary Linea RNA, we saw yet another significant industry pain point via the reduction of double-stranded RNA contamination. Our combined technologies enable our customers to produce better mRNA faster and we're pleased to be involved with new risk customers pursuing cutting-edge therapies.

借助我們的 Linea IVT 平台，該平台將 Linea IVT 模板與我們專有的 Linea RNA 相結合，我們透過減少雙股 RNA 污染看到了另一個重大的行業痛點。我們的組合技術使我們的客戶能夠更快地生產更好的 mRNA，我們很高興與追求尖端療法的新風險客戶合作。

Now as Jim noted, we are being onboarded as a validated GMP vendor of IVT template into the manufacturing workflows of two customers. One, a US based biopharma company. And the other a CDMO based in APAC. We expect to begin supplying Linea IVT templates for use by these customers in their manufacture of mRNA clinical trial materials in early calendar year '25 or our fiscal second quarter.

現在，正如 Jim 指出的那樣，我們正在作為 IVT 模板經過驗證的 GMP 供應商加入到兩個客戶的製造工作流程中。一是美國生物製藥公司。另一個是位於亞太地區的 CDMO。我們預計將在 25 年初或我們的第二財季開始提供 Linea IVT 模板，供這些客戶在 mRNA 臨床試驗材料的製造中使用。

We are also involved in an additional customer valuation where we were recently told that our IVT templates meet or exceed all of their GMP specs. We hope to be added as a qualified vendor with this customer in the near future with potential GMP runs in first half of calendar year 2025. In addition to these early success stories, we are currently engaged with numerous biotech, pharma and large CDMOs who are in the process of evaluating our Linea IVT templates.

我們也參與了額外的客戶評估，最近我們被告知我們的 IVT 範本滿足或超過了他們的所有 GMP 規格。我們希望在不久的將來成為該客戶的合格供應商，並可能在 2025 年上半年進行 GMP 運作。除了這些早期的成功案例之外，我們目前還與眾多生物技術、製藥和大型 CDMO 合作，他們正在評估我們的 Linea IVT 模板。

Slide 9 provides a sampling of evaluating customers who, if converted, have the potential to fill our GMP capacity in fiscal 2025. It's also notable that each of these customers have multiple assets in their pipeline and initial GMP success with any of these customers holds the potential for long-term manufacturing contracts.

投影片 9 提供了評估客戶的樣本，這些客戶如果轉換，有可能在 2025 財年填補我們的 GMP 產能。還值得注意的是，這些客戶中的每一個都在其管道中擁有多種資產，並且與這些客戶中的任何一個的初始 GMP 成功都擁有長期製造合約的潛力。

It's also significant that we are gaining traction with evaluation customers for our Linea IVT platform. The combination of our proprietary LineaRx and our IVT template allowed us to increase our relevance to the mRNA value chain for approximately 5% to approximately 30% of mRNA manufacturing cost, providing us with a much larger total addressable market than IVT templates alone.

同樣重要的是，我們的 Linea IVT 平台贏得了評估客戶的青睞。我們專有的LineaRx 和IVT 模板的結合使我們能夠提高與mRNA 價值鏈的相關性，從而將mRNA 製造成本降低約5% 至約30%，為我們提供了比單獨IVT 模板更大的總目標市場。

While just one year ago, our Linea IVT platform is now being evaluated by several customers, including a multinational biopharma company and a large APAC-based CDMO. Early customer data has been positive and our goal is to convert these evaluation customers into GMP supply contracts for both IVT templates and also enzymes in the coming fiscal quarters.

就在一年前，我們的 Linea IVT 平台現在正在接受多家客戶的評估，其中包括一家跨國生物製藥公司和一家位於亞太地區的大型 CDMO。早期客戶數據是積極的，我們的目標是在未來的財政季度將這些評估客戶轉化為 IVT 模板和酶的 GMP 供應合約。

Thanks to our recently completed manufacturing process development projects on our LineaRx, we now have the ability to manufacture this enzyme at reduced unit costs and in quantities necessary to meet customer demand in virtually any phase of the clinical trial process. The value of LineaRx (technical difficulty) further bolstered this quarter with our receipt of the first US patent with claims covering the enzyme composition of matter.

由於我們最近在 LineaRx 上完成的製造流程開發項目，我們現在能夠以更低的單位成本和必要的數量來製造這種酶，以滿足臨床試驗過程幾乎任何階段的客戶需求。隨著我們收到第一個美國專利，其權利要求涵蓋物質的酵素成分，LineaRx（技術難度）的價值在本季度得到了進一步提升。

Now looking ahead, we believe our goal to sell 100% of our current GMP capacity in fiscal 2025 is very feasible. Our optimism is not only based on the groundwork to customer relationships we have made over the past two years, but also in the prompting state of mRNA-based therapeutics. mRNA empowers much more than just vaccines against infectious disease, such as those against COVID-19. mRNA is a flexible technology that we believe will empower a diverse range of therapeutic modalities from personalized cancer vaccine to CAR-T and gene therapy.

現在展望未來，我們相信在 2025 財年出售 100% 現有 GMP 產能的目標是非常可行的。我們的樂觀不僅基於我們在過去兩年中所建立的客戶關係基礎，而且還基於基於 mRNA 的療法的蓬勃發展。 mRNA 的作用遠不止是針對傳染病的疫苗，例如 COVID-19 的疫苗。 mRNA 是一種靈活的技術，我們相信它將支持從個人化癌症疫苗到 CAR-T 和基因治療等多種治療方式。

Increasingly, we are seeing interest from customers that are using mRNA for the personalized cancer vaccine and modality that has seen recent success in the clinic. Here, the speed of manufacture is critical. And given that speed is one of our platform's main selling point, we believe we are very well positioned to capture new customers in this growing area.

我們越來越多地看到客戶對使用 mRNA 進行個人化癌症疫苗和治療方式產生興趣，這種疫苗和治療方式最近在臨床上取得了成功。在這裡，製造速度至關重要。鑑於速度是我們平台的主要賣點之一，我們相信我們有能力在這個不斷成長的領域吸引新客戶。

Likewise, mRNA-based CAR-T therapies have recently been shown to be safe and effective against autoimmune and also potentially cancer. This leads to yet another new market opportunity for our platform. We believe we are in the last stage of what has been two years of extraordinary efforts to create a new growth opportunity for Applied DNA. The development and launching of a new technology is never easy, but fortune favors the bold and we are excited for what the future holds.

同樣，基於 mRNA 的 CAR-T 療法最近已被證明能夠安全有效地對抗自體免疫疾病以及潛在的癌症。這為我們的平台帶來了另一個新的市場機會。我們相信，我們正處於兩年來為 Applied DNA 創造新的成長機會而付出的非凡努力的最後階段。新技術的開發和推出絕非易事，但命運眷顧勇敢者，我們對未來感到興奮。

Now I'll give the call back to Jim.

現在我會把電話回給吉姆。

Thank you much, Clay. Our LineaRx platform is the opportunity for our team and our investors to participate in the compelling future of biotherapeutics, which is evolving at lightning speed. Combined with the benefits of precision prescribing and powered by pharmacogenomics, we really find ourselves at the center of the new revolution in biotechnology.

非常感謝你，克萊。我們的 LineaRx 平台為我們的團隊和投資者提供了參與生物治療學令人矚目的未來的機會，生物治療學正在以閃電般的速度發展。結合精確處方的優勢和藥物基因組學的支持，我們確實處於生物技術新革命的中心。

Operator, you can now open the session to Q&A.

操作員，您現在可以開啟問答會話。

(Operator Instructions)

（操作員說明）

Yi Chen, Applied DNA.

陳毅，應用DNA。

Good afternoon. This is Dan on for Yi. Thanks for taking our questions. Also H.C. Wainwright. We were wondering how many customers for GMP manufacturing products do you expect to have by the end of 2024? And are there any customers beyond the two approved and third pending in conversations as well as what is the level of test volume for TR8 pharmacogenomic testing services you expect to have in the coming quarters? Thank you.

午安.這是對易的丹。感謝您回答我們的問題。還有 H.C.溫賴特。我們想知道到 2024 年底，您預計將擁有多少 GMP 製造產品的客戶？除了兩位已核准的客戶和第三個待定的客戶之外，還有其他客戶正在討論中嗎？謝謝。

Clay, would you like to take the first half and I'll take pharmacogenomics?

Clay，你願意上半部課，我來上藥物基因體學課嗎？

Absolutely. Sure. Hey, Dan. So to answer your first question about the number of GMP customers in fiscal 2024, I mean, we are launching our GMP facility at the end of fiscal 2024. So we don't expect to have signed contracts today that it launches. But that being said and as we talked about in the prepared remarks, we have been through the evaluation process with two large customers. And based on their manufacturing time line, which was really outside of our control, the indications are that those first GMP with manufacturing rounds will be early calendar year 2025.

絕對地。當然。嘿，丹。因此，為了回答您關於 2024 財年 GMP 客戶數量的第一個問題，我的意思是，我們將在 2024 財年末啟動我們的 GMP 設施。因此，我們預計今天不會簽署合約。但話雖這麼說，正如我們在準備好的演講中談到的那樣，我們已經與兩個大客戶進行了評估過程。根據他們的生產時間表（這確實超出了我們的控制範圍），有跡象表明，第一個 GMP 生產週期將在 2025 年初。

That being said, the GMP process is that, it's a process. It's not give us materials and we will end (inaudible) manufacture. There is a process development and scale-up aspect to it. So some of those activities that pre-date the GMP runs could happen in late fiscal 2024 or Q1 20 -- Q1 of fiscal 2025. Does that make sense?

話雖這麼說，GMP 流程就是這樣，它是一個流程。它不會給我們材料，我們將結束（聽不清楚）製造。它有一個工藝開發和放大方面。因此，在 GMP 運行之前進行的一些活動可能會在 2024 財年末或 20 財年第一季（即 2025 財年第一季）進行。這樣有道理嗎？

Yes, that's perfect. Thank you.

是的，那就完美了。謝謝。

And then in terms of -- I think you asked that in terms number of customers after fiscal 2024? Or does that answer your question?

然後，我想您問的是 2024 財年之後的客戶數量？或者這能回答你的問題嗎？

Whatever beyond 2024 would be -- just to get like a overall picture of how quickly you think this uptake is expected?

無論 2024 年之後會發生什麼——只是為了大致了解您認為預計這種吸收的速度有多快？

Yeah. So right now, I mean, we have the verbal commitments that we have discussed on this call for about half of our GMP capacity in early calendar year 2025. As we showed in that slide, we think we have a robust sales funnel for the rest of that capacity and we're going to work to close that. So it's not really a number of customers game. It's the size and the therapeutic modality of their mRNA order that it really matters.

是的。所以現在，我的意思是，我們已經在這次電話會議上討論過，我們已經做出了口頭承諾，承諾在 2025 年初實現約一半的 GMP 產能。正如我們在幻燈片中所示，我們認為我們擁有一個強大的銷售管道來滿足其餘產能的需求，我們將努力關閉它。所以這並不是真正的客戶數量遊戲。真正重要的是它們的 mRNA 序列的大小和治療方式。

Thank you. That's perfect.

謝謝。那很完美。

And Dan, to answer your pharmacogenomic question. We believe that we are the first commercial entity in New York State to be offering a broad-based panel. We explore as many as 130 alleles in pharmacogenomics and to be targeting initially New York State. So other testers come from without the state, outside of the state. And as a consequence, we believe we'll have a turnaround time advantage in providing service.

丹，回答你的藥物基因組問題。我們相信，我們是紐約州第一個提供廣泛基礎小組的商業實體。我們在藥物基因組學中探索了多達 130 個等位基因，最初的目標是紐約州。所以其他測試人員來自州外、州外。因此，我們相信我們將在提供服務方面擁有周轉時間優勢。

Now speaking of service, we're starting with a service-oriented market and that is the concierge physician practices that we have been talking to really for the last year. And this is a means for these physicians to implement precision prescribing and to compete effectively in the concierge marketplace. So we've been very excited by the initial response and we hope to build an adequate volume of that form of testing in due course, actually in smaller quanta.

現在談到服務，我們從以服務為導向的市場開始，這就是我們去年一直在談論的禮賓醫生實踐。這是這些醫生實施精準處方並在禮賓市場中有效競爭的手段。因此，我們對最初的反應感到非常興奮，我們希望在適當的時候建立足夠數量的這種形式的測試，實際上是以較小的量。

And the idea behind the smaller quanta, a typical concierge physician has somewhere between 250 and 500 patients, is it allows us to provide the white glove service consistent with the concierge physician and to habituate the workflow that we will need in order to service the much larger enterprise customer that we want to begin tackling say, by the end of the first quarter of '25.

較小的量子背後的想法是，一個典型的禮賓醫生有 250 到 500 名患者，它允許我們提供與禮賓醫生一致的白手套服務，並習慣我們為更多患者提供服務所需的工作流程。希望在25 年第一季末開始解決更大的企業客戶問題。

Those customers, which include things like large hospital networks and here on Long Island, we're surrounded by them, we believe there is a large opportunity to provide services of pharmacogenomics to companies that are self-insured, to counties and governments that are self-insured and we believe that we can create large demand that way.

這些客戶，包括大型醫院網絡之類的東西，在長島，我們被他們包圍著，我們相信有很大的機會向自我保險的公司、自我保險的縣和政府提供藥物基因組學服務。相信我們可以透過這種方式創造大量需求。

The capacity we've built for is adequate to service in a single shift more than $25 million of revenue per year. But it's imminently scalable. Of course, we can add more shifts. We can add more testing lines as well. So we're excited about the opportunity and we're anxious to get started.

我們建構的產能足以在單班次中提供每年超過 2500 萬美元的收入。但它很快就能擴展。當然，我們可以增加更多的班次。我們還可以添加更多的測試線。因此，我們對這個機會感到興奮，並渴望開始。

That sounds great. If I could ask a follow-up, are there any other states that you're targeting? And do they require a similar approval process in those states?

聽起來很棒。如果我可以詢問後續問題，您還有其他目標州嗎？這些州是否需要類似的審批流程？

It's funny you should ask because we're just completing our registration that would enable us to sell, and I believe, 47 additional states. There is no validation required, thanks to the fact that the New York State validation is itself so difficult and it took us over a year to obtain approval, in part because this was our first genomics LVT and it was deemed during the validation process, as they always are, high risk. And so it was given very careful consideration before it was approved. But now to march onward to other states, all we have to do is fill out an application.

有趣的是，您應該問這個問題，因為我們剛剛完成註冊，這將使我們能夠銷售（我相信）另外 47 個州。不需要進行驗證，因為紐約州的驗證本身就非常困難，我們花了一年多的時間才獲得批准，部分原因是這是我們的第一個基因組學 LVT，並且在驗證過程中被認為是它們始終是高風險的。因此在批准之前經過了非常仔細的考慮。但現在要進軍其他州，我們要做的就是填寫一份申請表。

That's awesome. Congratulations on the approval and we're looking forward to the ramp. Thank you.

太棒了。恭喜您獲得批准，我們期待坡道的到來。謝謝。

Thank you.

謝謝。

(Operator Instructions) This concludes our question and answer session. I would like to turn the conference back over to Dr. 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·海沃德博士發表閉幕詞。

Thank you, Cindy, and thank you all for attending our call, and we look forward to keeping you updated on our progress as we move through this very exciting period. Thank you.

謝謝辛迪，感謝大家參加我們的電話會議，在我們度過這個非常激動人心的時期時，我們期待著向您通報我們的最新進展。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。