Co-Diagnostics Inc (CODX) 2025 Q2 法說會逐字稿

Ladies and gentlemen, thank you for standing by. My name is Krista, and I will be your conference operator today. At this time, I would like to welcome everyone to the Co Diagnostics Inc second quarter 2025 earnings conference call and webcast. (Operator Instructions)

女士們、先生們，感謝你們的支持。我叫克里斯塔，今天我將擔任您的會議主持人。現在，我歡迎大家參加 Co Diagnostics Inc 2025 年第二季財報電話會議和網路廣播。（操作員指示）

Thank you. I would like to turn the conference over to Andrew Benson, Head of Investor Relations. Andrew, please go ahead.

謝謝。我想把會議交給投資者關係主管安德魯·本森（Andrew Benson）。安德魯，請講。

Good afternoon, everyone. Thank you all for participating in today's conference call. On the line today from Co-Diagnostics, we have Dwight Egan, Chief Executive Officer; and Brian Brown, Chief Financial Officer. Earlier today, Co-Diagnostics released financial results from the second quarter ended June 30, 2025. A copy of the press release is available on the company's website. We will begin with management's prepared remarks and then open up the call to analyst Q&A.

大家下午好。感謝大家參加今天的電話會議。今天 Co-Diagnostics 在線採訪了首席執行官 Dwight Egan 和首席財務官 Brian Brown。今天早些時候，Co-Diagnostics 發布了截至 2025 年 6 月 30 日的第二季財務業績。新聞稿副本可在該公司網站上查閱。我們將從管理階層準備好的發言開始，然後開始分析師問答環節。

Before we begin, we would like to inform listeners that certain statements made by Co-Diagnostics during this call, which are not historical facts are forward-looking statements. This includes statements concerning the company's Co-Dx PCR testing platform, which requires regulatory approval and marketing authorization for diagnostic use and is not currently for sale.

在我們開始之前，我們想告知聽眾，Co-Diagnostics 在本次電話會議中做出的某些陳述並非歷史事實，而是前瞻性陳述。其中包括有關該公司 Co-Dx PCR 檢測平台的聲明，該平台需要監管部門的批准和行銷授權才能用於診斷，目前尚未出售。

In addition to diagnostic test developments and timing for commencement of clinical evaluations. Actual outcomes and results may differ materially from what is expressed or implied in any statement. Important factors, which could cause actual results to differ materially from those in these forward-looking statements are detailed in Co-Diagnostics filings with the SEC.

除了診斷測試的發展和臨床評估開始的時間之外。實際結果可能與任何聲明中表達或暗示的內容有重大差異。可能導致實際結果與這些前瞻性陳述中的結果大不相同的重要因素在 Co-Diagnostics 向美國證券交易委員會提交的文件中進行了詳細說明。

Co-Diagnostics assumes no obligation and expressly disclaims any duty to update any forward-looking statements to reflect events or circumstances occurring after this call or to reflect the occurrence of unanticipated events. In addition, the company may discuss certain non-GAAP financial measures during today's call.

Co-Diagnostics 不承擔任何義務，並明確表示不承擔更新任何前瞻性陳述以反映本次電話會議後發生的事件或情況或反映意外事件的發生的義務。此外，公司可能會在今天的電話會議上討論某些非公認會計準則財務指標。

These non-GAAP financial measures should not be considered a replacement for and should be read together with GAAP results. We refer you to the company's earnings release issued shortly before this call, which contains reconciliations to the non-GAAP financial measures presented to their most comparable GAAP results.

這些非 GAAP 財務指標不應被視為 GAAP 結果的替代品，而應與 GAAP 結果一起解讀。我們請您參閱本公司在本次電話會議前不久發布的收益報告，其中包含與最具可比性的 GAAP 結果相對應的非 GAAP 財務指標。

At this time, I would like to turn the call over to Co-Diagnostics Chief Executive Officer, Dwight Egan. Dwight?

現在，我想將電話轉給 Co-Diagnostics 執行長 Dwight Egan。德懷特？

Thank you, Andrew, and good afternoon, everyone. Thank you for joining Co-Diagnostics Second Quarter 2025 Earnings Call. The second quarter of this year continued to bring steady advancements of our Co-DX PCR point-of-care platform and thanks to the diligent efforts of our team working towards our goal to bring the instrument to market. We remain on track to initiate clinical evaluations for all tests in our pipeline during 2025.

謝謝你，安德魯，大家下午好。感謝您參加 Co-Diagnostics 2025 年第二季財報電話會議。今年第二季度，我們的 Co-DX PCR 即時診斷平台繼續穩步發展，這要感謝我們團隊的辛勤努力，我們正朝著將儀器推向市場的目標努力。我們仍計劃在 2025 年對我們正在進行的所有測試啟動臨床評估。

In addition to the Co-DX PCR COVID-19 test, which is expected to imminently begin enrolling participants for its clinical evaluations, the test pipeline for the new platform includes real-time PCR tests for flu A and B, COVID and RSV in a 4-plex, respiratory panel supported by a grant from the National Institute of Health's RADx Tech program as well as test for tuberculosis or TB and an HPV eight type multiplex panel, both of which are supported by grants from the Bill & Melinda Gates Foundation.

除了預計很快就會開始招募參與者進行臨床評估的 Co-DX PCR COVID-19 檢測外，新平台的檢測流程還包括由美國國立衛生研究院 RADx Tech 計畫資助的 4 重呼吸道檢測面板中的甲型流感和乙型流感、COVID 和呼吸道合胞病毒的即時 PCR 檢測，以及由比爾和林琳達·蓋茲型檢測和 HPV TB 檢測的八型病毒檢測或多型 HPV 檢測。

These indications were identified as amongst the best opportunities in the near term to bring our unique technology and platform to market and to help advance the Co-Diagnostics vision of increasing the accessibility of affordable, high-quality diagnostics in the States, India and around the world.

這些跡像被認為是近期將我們獨特的技術和平台推向市場的最佳機會，並有助於推動 Co-Diagnostics 的願景，即提高美國、印度和世界各地獲得負擔得起的高品質診斷服務的可及性。

Our focus remains on bringing the Co-DX PCR platform to the point-of-care market which has included incorporating ongoing advancements developed by our scientific engineering and software development teams as we prepare for our upcoming regulatory submissions in the appropriate jurisdictions for each indication.

我們的重點仍然是將 Co-DX PCR 平台引入即時診斷市場，其中包括結合我們的科學工程和軟體開發團隊不斷取得的進步，為即將在適當的司法管轄區針對每種適應症提交的監管文件做準備。

As mentioned in our previous call, the augmented Co-DX PCR COVID-19 test underwent extended verification testing, and we are pleased to report that the clinical evaluation sites for this updated tests are currently being trained with testing of trial participants expected to begin imminently.

正如我們在先前的電話會議中提到的那樣，增強型 Co-DX PCR COVID-19 測試已經過擴展驗證測試，我們很高興地報告，針對此更新測試的臨床評估站點目前正在接受培訓，預計即將開始對試驗參與者進行測試。

Our plans continue to be to submit a 510(k) application to the FDA for this updated version of our COVID-19 test after the completion of the clinical evaluations. We look forward to the platform's initial introduction to the market next year and to the disruptive potential of this new diagnostic solution.

我們的計劃是在完成臨床評估後，繼續向 FDA 提交此更新版本的 COVID-19 測試的 510(k) 申請。我們期待該平台明年首次推向市場，並期待這項新診斷解決方案的顛覆性潛力。

Perhaps the greatest opportunity for the platform to disrupt the current testing paradigm is through tuberculosis. TB caused an estimated 1.25 million deaths in 2023 according to the World Health Organization, making it the number 1 infectious disease killer globally. Several preliminary analytical and pre-clinical studies for the Co-DX PCR MTB test have been completed or are currently in process

也許該平台打破當前檢測模式的最大機會是透過結核病。根據世界衛生組織估計，2023年結核病將導致125萬人死亡，成為全球第一大傳染病殺手。Co-DX PCR MTB 檢測的幾項初步分析和臨床前研究已經完成或正在進行中

and testing on clinical samples have demonstrated the high performance properties of the test. We believe that the efficient affordable workflow process supported by the straightforward mobile app will help to speed adoption at the point-of-care in areas across India and Africa that have previously had little to no access to gold standard PCR diagnostic technology for a disease that is highly treatable if diagnosed early and accurately.

並對臨床樣本進行了測試，證明了該測試的高性能特性。我們相信，這款簡單易用的行動應用程式支援高效且經濟的工作流程，將有助於加快印度和非洲地區在醫療點的採用，這些地區以前很少或根本沒有機會獲得黃金標準 PCR 診斷技術來治療這種疾病，如果早期準確診斷，這種疾病是可以治癒的。

The company remains on track to begin clinical evaluations for our TB test in both India and South Africa before the end of 2025, which will gather data to support regulatory submissions to the South Africa Health Products Regulatory Agency, or SAHPRA, and the Central Drugs Standard Control Organization, or CDSCO in India helping to increase the accessibility of high-quality, real-time PCR diagnostics in India has been a focus of the company since the early days of its founding. 27% of global TB cases and 26% of global TB deaths were found in India alone in 2023, and the country continues to be our top priority market for TB testing. Our footprint in India is significantly strengthened by our joint venture, CoSara Diagnostics, who provide substantial experience and regulatory commercial and manufacturing infrastructure in India.

該公司仍有望在 2025 年底之前在印度和南非開始對我們的結核病檢測進行臨床評估，這將收集數據以支持向南非衛生產品監管局 (SAHPRA) 和印度中央藥品標準控制組織 (CDSCO) 提交的監管文件，幫助提高高品質的實時 PCR 診斷性，自公司關注初期以來一直是公司關注的重點。 2023 年，僅在印度就發現了全球 27% 的結核病病例和 26% 的結核病死亡病例，該國仍然是我們結核病檢測的首要市場。我們的合資企業 CoSara Diagnostics 大大增強了我們在印度的業務，該公司在印度提供了豐富的經驗以及監管商業和製造基礎設施。

Principal manufacturing for tests and instruments will take place in our domestic manufacturing facility in South Salt Lake, inaugurated a little over a year ago, before being completed in the upgraded CoSara manufacturing campus prior to distribution and commercialization in India. As we proceed with the preparations for the clinical evaluations, we continue to engage with local health officials and potential customers in both India and Africa to evaluate the most effective and efficient commercialization strategy in specific target markets.

測試和儀器的主要製造將在我們位於南鹽湖的國內製造工廠進行，該工廠於一年多前落成，然後在升級後的 CoSara 製造園區完成，之後在印度分銷和商業化。在進行臨床評估準備的同時，我們繼續與印度和非洲的當地衛生官員和潛在客戶合作，以評估特定目標市場中最有效、最高效的商業化策略。

We are pleased to report that the Co-DX PCR ABCR 4-plex respiratory panel is nearly prepared for clinical evaluations expected to begin concurrent with the 2025 North American fall and winter flu season. The test has been designed to build simultaneous differentiated real-time PCR test results for patients suspected of having flu A and B, COVID-19 or RSV. It remains the test with the highest domestic demand in our pipeline, driven by the burden these diseases place on everyday life in United States and around the world.

我們很高興地報告，Co-DX PCR ABCR 4-plex 呼吸道檢測組已基本準備好進行臨床評估，預計將與 2025 年北美秋季和冬季流感季節同時開始。該測試旨在為疑似患有甲型流感和乙型流感、COVID-19 或呼吸道合胞病毒的患者建立同步差異化即時 PCR 測試結果。由於這些疾病對美國和世界各地日常生活造成的負擔，它仍然是我們研發過程中國內需求最高的測試。

Once complete, the data collected by the clinical evaluations will be used in a 510(k) application to the FDA. 510(k) clearance will not only allow the test to be commercialized as an infectious disease in vitro diagnostic in the United States, but also in other countries around the world to accept US FDA clearance and regulatory approval following a straightforward registration process in those countries.

一旦完成，臨床評估收集的數據將用於向 FDA 提交的 510(k) 申請。 510(k) 批准不僅允許該測試在美國作為傳染病體外診斷進行商業化，而且還允許在世界其他國家透過簡單的註冊程序接受美國 FDA 的批准和監管批准。

This international commercialization allowed model allowed Co-DX to achieve significant growth during the pandemic based on the sales of our centralized lab COVID-19 PCR test, and we believe we will be able to follow a similar pathway for this new platform.

這種國際商業化模式使得 Co-DX 在疫情期間憑藉我們集中實驗室 COVID-19 PCR 檢測的銷售實現了顯著增長，我們相信我們將能夠在這個新平台上走類似的道路。

Finally, the Co-DX PCR HPV eight type multiplex panel is also on track to initiate clinical evaluations before year-end. HPV is the most widespread and sexually transmitted infection worldwide. And despite the widespread availability of an HPV vaccine, there remains a vast need for HPV testing around the world.

最後，Co-DX PCR HPV 八型多重檢測面板也預計在年底前啟動臨床評估。HPV 是全球最廣泛、最常透過性行為傳染的感染。儘管 HPV 疫苗已廣泛普及，但世界各地對 HPV 檢測的需求仍然龐大。

Human papillomavirus has many subtypes of which are linked to cervical cancer, which causes hundreds of thousands of deaths annually. We believe the Co-DX PCR platform can have a significant impact on testing accessibility and efficiency, which remain key constraints to mitigating the impact of HPV on global health.

人類乳突病毒有多種亞型，其中大多數與子宮頸癌有關，每年導致數十萬人死亡。我們相信 Co-DX PCR 平台可以對檢測的可及性和效率產生重大影響，而這仍然是減輕 HPV 對全球健康影響的關鍵限制因素。

Supported by a grant from the Bill & Melinda Gates Foundation and powered by our Co-Primers technology, this HPV assay is designed to simultaneously detect 8 different high-risk HPV subtypes from a single self-collected vaginal swab sample and differentiate between HPV 16, HPV 18 and HPV 45. These are considered to be the three most carcinogenic HPV variations, collectively responsible for roughly 75% of cervical cancers worldwide.

此 HPV 檢測由比爾和梅琳達蓋茲基金會提供資助，並採用我們的 Co-Primers 技術，旨在從單一自我採集的陰道拭子樣本中同時檢測 8 種不同的高危險 HPV 亞型，並區分 HPV 16、HPV 18 和 HPV 45。這被認為是三種最致癌的 HPV 變異體，共同導致了全球約 75% 的子宮頸癌。

Early detection of HPV can improve intervention and treat of precancerous cells and lesions before they develop into cervical other types of cancer. And we believe that a test with these performance characteristics has the potential to dramatically increase the availability of HPV PCR diagnostics around the world.

早期發現HPV可以改善對癌前細胞和病變的干預和治療，防止其發展為子宮頸其他類型的癌症。我們相信，具有這些性能特徵的測試有可能大幅提高全球範圍內 HPV PCR 診斷的可用性。

Like TB, the regulatory pathway for this test will follow areas of greatest need in India and Africa and clinical evaluations to support submissions to the CDSCO and SAHPRA are anticipated to begin this year. We look forward to initiation and completion of the upcoming clinical evaluations, regulatory submissions and commercialization of this test on the Co-DX PCR Pro.

與結核病一樣，該測試的監管途徑將遵循印度和非洲最需要的地區，預計今年將開始進行臨床評估，以支持向 CDSCO 和 SAHPRA 提交申請。我們期待在 Co-DX PCR Pro 上啟動和完成即將進行的臨床評估、監管提交和商業化該測試。

One of the most original and embedded features of the Co-DX PCR platform is the cloud-based analysis of tests performed on the Co- DX PCR Pro which allows de-identified epidemiological data to be made available to help departments at the local, regional, national or international level.

Co-DX PCR 平台最原始、最嵌入式的功能之一是在 Co-DX PCR Pro 上執行的測試的基於雲端的分析，該分析允許提供去識別的流行病學數據來幫助地方、區域、國家或國際級別的部門。

The ability to track the spread of infectious diseases in real time is often compartmentalized in other testing paradigms or even absent outright. And we anticipate this situational awareness can provide health officials with key data and insights that could save lives and limit outbreaks. We believe that this feature was a key factor in receiving the support of several leading organizations who share in our

即時追蹤傳染病傳播的能力在其他測試範式中通常是被分割的，甚至完全不存在。我們預計，這種態勢感知可以為衛生官員提供關鍵數據和見解，從而挽救生命並限制疫情爆發。我們相信，這項特點是獲得與我們共享的幾家領先組織支持的關鍵因素

passion for improving the global health infrastructure, including the Bill & Melinda Gates Foundation SMART4TB and the National Institute of Health's RADx Tech program.

熱衷於改善全球衛生基礎設施，包括比爾和梅琳達蓋茲基金會的 SMART4TB 和美國國立衛生研究院的 RADx Tech 計劃。

As we near the initiation of clinical evaluations for all four tests currently in our Co-DX PCR product pipeline, and firm up our pathway to commercialization, we anticipate increasing activity at trade shows and other events to continue engaging with local and international potential customers and key stakeholders.

隨著我們即將啟動目前 Co-DX PCR 產品線中所有四項測試的臨床評估，並鞏固我們的商業化道路，我們預計將在貿易展覽會和其他活動中增加活動，以繼續與本地和國際潛在客戶和主要利益相關者接觸。

Over the past couple of years, we have developed solid relationships with local trade and commerce organizations, some of which support the growth of Utah's businesses by offering grants for their travel and participation in trade shows and conferences. We have been successful in securing grants to help offset the cost of some recent and upcoming events. And we will continue to pursue these and other opportunities to be mindful of our spend while we prepare for our expansion.

在過去的幾年裡，我們與當地的貿易和商業組織建立了牢固的關係，其中一些組織透過為猶他州的企業提供旅行和參加貿易展覽會和會議的補助來支持猶他州企業的發展。我們已成功獲得補助金，以幫助抵消一些近期和即將舉行的活動的費用。我們將繼續尋求這些和其他機會，在為擴張做準備的同時注意控制我們的支出。

To conclude, I want to emphasize our commitment to achieve our clinical evaluations and regulatory submission objectives as the next critical steps to successfully launching the Co-DX PCR Pro instrument and test kits to the world.

最後，我想強調我們致力於實現臨床評估和監管提交目標，這是成功向世界推出 Co-DX PCR Pro 儀器和測試套件的下一個關鍵步驟。

This pathway remains the most expeditious way to return value to our shareholders and the foundation we have built for near and long-term success is possible, thanks to the investments in infrastructure, technology and people that we have made along the way.

這一途徑仍然是我們向股東回報價值的最快捷方式，而且我們為近期和長期成功奠定的基礎之所以能夠實現，得益於我們一路以來在基礎設施、技術和人才方面的投資。

We believe this framework will allow us to replicate the process more quickly and efficiently for other critical infectious disease test panels in the future and can be applied to other areas of interest such as veterinary, agricultural and livestock applications.

我們相信，該框架將使我們能夠在未來更快、更有效地複製該流程，用於其他關鍵傳染病檢測小組，並可應用於其他感興趣的領域，如獸醫、農業和畜牧業應用。

The company remains on schedule to reach the critical milestones discussed here, as well as to expand our manufacturing capacity domestically and India to be able to scale to meet market demand upon platform launch.

公司仍將按計劃實現這裡討論的關鍵里程碑，並擴大我們在國內和印度的製造能力，以便能夠在平台推出後擴大規模以滿足市場需求。

We believe the Co-DX PCR platform can revolutionize and set a new bar for the affordability, accessibility, decentralization, accurate gold standard PCR infectious disease testing. I'm very proud of the work of our team and look forward to another quarter of success.

我們相信 Co-DX PCR 平台可以帶來革命，並為可負擔性、可及性、分散化、準確的黃金標準 PCR 傳染病檢測樹立新的標準。我對我們團隊的工作感到非常自豪，並期待下一個季度的成功。

With that, I will now turn the call over to Brian to discuss our financial results. Brian?

說完這些，我現在將電話轉給布萊恩，討論我們的財務表現。布賴恩？

Thanks, Dwight, and thanks to everyone who joined today's call. For the second quarter of 2025, total revenue decreased to $0.2 million as compared to $2.7 million in the prior year same period. In the prior year same period , revenue from grants represented $2.5 million, while all revenue recognized during the second quarter of 2025 came from product sales.

謝謝，德懷特，也感謝今天參加電話會議的所有人。2025 年第二季度，總營收從去年同期的 270 萬美元下降至 20 萬美元。去年同期，贈款收入為 250 萬美元，而 2025 年第二季確認的所有收入均來自產品銷售。

Total operating expenses for the second quarter of 2025 decreased to $8.2 million from $10.1 million in the second quarter of 2024. This decrease continues to reflect our efforts to become more operationally efficient.

2025 年第二季的總營運費用從 2024 年第二季的 1,010 萬美元降至 820 萬美元。這一下降繼續反映了我們為提高營運效率所做的努力。

Research and development expenses in the second quarter of 2025 were $4.7 million compared to $5.6 million during the prior year comparable period. Net loss for the second quarter of 2025 was $7.7 million or a loss of $0.23 per fully diluted share compared to a net loss of $7.6 million or a loss of $0.25 per fully diluted share in the prior year comparable period.

2025 年第二季的研發費用為 470 萬美元，去年同期為 560 萬美元。2025 年第二季淨虧損為 770 萬美元，即每股完全攤薄虧損 0.23 美元，而去年同期淨虧損為 760 萬美元，即每股完全攤薄虧損 0.25 美元。

For the EBITDA was a loss of $7.2 million compared to an adjusted EBITDA loss of $5.9 million in the second quarter of 2024. We ended the second quarter with $13.4 million in cash, equivalents and marketable investment securities. As always, we are managing our spend to maintain a healthy balance sheet as we position ourselves for commercialization.

EBITDA 虧損 720 萬美元，而 2024 年第二季調整後 EBITDA 虧損 590 萬美元。我們在第二季結束時擁有 1,340 萬美元的現金、等價物和有價投資證券。像往常一樣，我們正在管理支出以保持健康的資產負債表，並為商業化做好準備。

Throughout the year, we will continue to make improvements to our operating footprint that will drive efficiency gains and cost savings. We plan to provide for the company's capital requirements through equity and/or debt financing, additional grant funding and operational efficiencies.

全年我們將繼續改善我們的營運足跡，以提高效率並節省成本。我們計劃透過股權和/或債務融資、額外撥款和營運效率來滿足公司的資本需求。

More specifically, we are using our ATM to generate capital when appropriate. We are evaluating various debt and equity financing structures, and we'll continue to press forward with seeking grant support for our Co-DX PCR platform.

更具體地說，我們在適當的時候使用 ATM 來產生資本。我們正在評估各種債務和股權融資結構，並將繼續努力為我們的 Co-DX PCR 平台尋求資助。

In the near term, we are focused on progressing our development pipeline towards completing clinical evaluations and preparations for regulatory submissions and are managing our allocation of time and resources accordingly. We're very excited about our continued progress and remain optimistic about 2025 multiple commercial launches in 2026 and future developments within our test pipeline. I look forward to providing you with more updates on next quarter's call.

短期內，我們將專注於推進開發流程，完成臨床評估和監管提交的準備工作，並相應地管理我們的時間和資源分配。我們對持續的進步感到非常興奮，並對 2025 年、2026 年的多次商業發布以及我們測試管道的未來發展保持樂觀。我期待在下個季度的電話會議上為您提供更多更新資訊。

With that, I will now turn the presentation back over to Dwight.

現在，我將演講交還給德懷特。

Thank you, Brian. To close, we want to extend our gratitude to Co-Diagnostics shareholders and to our employees whose consistent dedication and hard work is one of our most valuable assets to achieving the Co-DX vision.

謝謝你，布萊恩。最後，我們要向 Co-Diagnostics 股東和員工表示感謝，他們一貫的奉獻和辛勤工作是我們實現 Co-DX 願景的最寶貴資產之一。

We will now take questions from our analysts. Operator?

我們現在將回答分析師的問題。操作員？

(Operator Instructions)

（操作員指示）

Yi Chen with HC Wainwright.

陳逸與 HC Wainwright 在一起。

Hi, This is Eduardo on for Yi. I was hoping if you could just kind of repeat your expected time line. You mentioned that all sites are being trained and you're going to start recruiting imminently. I was just hoping if I could get a time line for the specific tests in order, which one you expect to have earlier completion of those trials and then the consequent 510(k) applications. Just kind of get a feel for the progression of cadence of things.

大家好，我是易建聯的愛德華多。我希望您能重複您預期的時間表。您提到所有站點都在接受培訓，並且即將開始招募。我只是希望能夠獲得按順序排列的具體測試的時間表，您希望哪一個測試能夠更早完成這些試驗，然後完成隨後的 510（k）申請。只是有點感受事物節奏的進展。

Yes, thank you for the question. Our clinical trials for all four of the indications that are COVID-19, our multiplex flu A/B, COVID-19 and RSV test, our MTB or tuberculosis test and our HPV or human papillomavirus test. We expect all of those indications to be into clinical trials during the remainder of this calendar year. We anticipate to begin with the COVID-19 test which has already begun its site visits and training prior to putting customers through the trial or applicants through the trial.

是的，謝謝你的提問。我們針對 COVID-19 所有四種適應症進行的臨床試驗、多重流感 A/B、COVID-19 和 RSV 測試、我們的 MTB 或結核病測試以及我們的 HPV 或人類乳突病毒測試。我們預計所有這些適應症都將在今年剩餘時間內進入臨床試驗階段。我們預計將從 COVID-19 測試開始，在讓客戶或申請人參加試驗之前，該測試已開始現場訪問和培訓。

We believe that the next test up will be our ABCR or multiplex flu A/B over, COVID and RSV test. And probably the next one after that will be our tuberculosis test followed by HPV. That order could with respect to the final treatment, we expect the need first for all of them to commence clinical trials during the remainder of this calendar year.

我們相信，下一個測試將是我們的 ABCR 或多重流感 A/B、COVID 和 RSV 測試。下一步可能就是進行結核病檢測，然後再進行 HPV 檢測。該命令可能與最終治療有關，我們預計首先需要他們在今年剩餘時間內開始臨床試驗。

Got it. That's really helpful. And you expect applications, are you going to prioritize them in that order as they finish as well? Or you think you'd prioritize TB or multiplex given the acute need, both internationally and domestically for those two, respectively?

知道了。這真的很有幫助。並且您預計申請完成後，您是否也會按照該順序對它們進行優先排序？或者您認為，鑑於國際和國內對結核病或多發性硬化症的迫切需求，您會優先考慮結核病或多發性硬化症？

Well, we believe that there is a solid need for all four of those panels, the MGB and HPV test are targeted mainly to India and the affirmations including South Africa. We also believe that COVID still is a vibrant market, including in the US and we're seeking FDA approval for a 510(k) application for both the COVID-19 test and for the multiplex ABCR test, again, Flu A/B, COVID and RSV.

嗯，我們相信這四種檢測方法都有迫切的需求，MGB 和 HPV 檢測主要針對印度和包括南非在內的國家。我們也相信，COVID 仍然是一個充滿活力的市場，包括在美國，我們正在尋求 FDA 批准 COVID-19 測試和多重 ABCR 測試的 510(k) 申請，同樣針對流感 A/B、COVID 和 RSV。

So we know that COVID is there was a lot of COVID fatigue out there, but it's still the number two killer in terms of infectious disease pathogens out there. And so we think there's still a robust market for COVID. And we anticipate that, that will be the first one up.

因此，我們知道，儘管人們對 COVID 感到厭倦，但就傳染病病原體而言，它仍然是第二大殺手。因此我們認為 COVID 市場仍然強勁。我們預計這將是第一個。

Got it. So COVID first. Got it. And curious If you have some visibility towards commercial launch, I know maybe that might be a ways down. But if you have any visibility there and how you plan your marketing strategy, you're planning on point-of-care or over- the-counter. Are you in conversations with distributors at this point in time? Or how you plan on executing in regard to commercial launch?

知道了。所以首先要考慮的是 COVID。知道了。我很好奇，如果您對商業發布有一些了解，我知道這可能還有一段距離。但是，如果您對此有任何了解，並且知道如何規劃行銷策略，那麼您就會計劃在護理點或非處方藥方面進行行銷。您目前正在與經銷商進行談判嗎？或者您計劃如何執行商業發布？

Well, with respect to getting into commercialization, we plan to do that as soon as we have a clearance from the FDA in the case of COVID-19. We don't expect that the clinical trial on submission with the FDA will be protracted. The FDA generally has about a 120- day period in which they endeavor to clear a test. It doesn't always happen that way. But what we believe with what we will be doing, that is a reasonable time frame after we get this commission done.

嗯，關於商業化，我們計劃在獲得 FDA 對 COVID-19 的批准後立即進行商業化。我們預計向 FDA 提交的臨床試驗不會拖延很久。FDA 通常有大約 120 天的時間來努力完成測試。但事情並不總是這樣。但我們相信，在完成這項任務後，我們會有一個合理的時間框架。

As to the clinical trial that depends largely on how many people that come to the testing sites actually have COVID because we will need to have a certain number of positive and negative applicants in order to conclude the clinical trial.

至於臨床試驗，這在很大程度上取決於有多少人來到檢測點實際感染了 COVID，因為我們需要有一定數量的陽性和陰性申請者才能完成臨床試驗。

The other part of your question with respect to where we will deploy it from a commercialization standpoint is really as follows. In the United States, we are targeting physician offices and clinics. This is a point-of-care application. We're also targeting skilled nursing facilities, res homes, they are the vulnerable population that has a need for extensive testing. We also anticipate doing marketing into the home market. So we are seeking a clearance for a home use.

您問題的另一部分關於我們從商業化角度部署到哪裡，實際上如下。在美國，我們的目標是醫生辦公室和診所。這是一個即時護理應用程式。我們也瞄準了專業護理機構、養老院，他們是需要廣泛檢測的弱勢群體。我們也期待進軍國內市場。因此，我們正在尋求家庭使用的許可。

And finally, we are expecting to have activity in the pharmacy market. There's tens of thousands of pharmacies in the United States many of which are set up to test. And we believe that will also be a fertile market for us. So those are the areas in the United States where we're targeting for the COVID and for the ABCR test.

最後，我們預期在藥局市場開展活動。美國有數萬家藥局，其中許多都設有檢測機構。我們相信這對我們來說也將是一個肥沃的市場。這些就是我們在美國針對 COVID 和 ABCR 測試所瞄準的地區。

In India, we're mainly targeting the primary health care facilities where they almost 30,000 primary care centers that are primarily microscopy that really needs to be replaced with our type of technology that is a molecular technology. We have the gold standard technology for that type of application including its accessibility, its affordability and its accuracy.

在印度，我們主要針對初級保健機構，那裡有近 30,000 個初級保健中心，主要使用顯微鏡，這些顯微鏡確實需要用我們的分子技術來取代。我們擁有該類應用的黃金標準技術，包括其可近性、可負擔性和準確性。

Got it. And would you expect just trying to add the time lines together. So obviously, there's some variability in the readout for the COVID trial like you mentioned. I'm curious, so would this be commercial launch potentially end of 2026, early 2027?

知道了。您是否期望僅嘗試將時間軸加在一起。因此，顯然，正如您所提到的，COVID 試驗的讀數存在一些差異。我很好奇，這會不會是在 2026 年底或 2027 年初進行商業發布？

Well, I hope we have the commercialization before the end of 2026. I would think that we'll be wrapping that up because we're imminently beginning the clinical trial in COVID. I believe we'll be wrapping that up near year-end and that sometime in that by the end of the second quarter, we have a reasonable possibility of having it cleared through the FDA. That's not something we can guarantee, of course, but I would be surprised if it takes us clear out until the end of the year to get something into the market. I'd look more to the midyear.

嗯，我希望我們能在 2026 年底前商業化。我認為我們將會結束這項工作，因為我們即將開始 COVID 的臨床試驗。我相信我們將在年底前完成這項工作，並且在第二季末的某個時候，我們有相當大的可能性讓它通過 FDA 的批准。當然，這不是我們可以保證的，但如果我們要到今年年底才能將產品推向市場，我會感到驚訝。我會更關注年中的情況。

Got it. Thanks so much for the clarity and for taking the questions.

知道了。非常感謝您的澄清和回答問題。

Thank you.

謝謝。

And that concludes our question-and-answer session, and that does conclude today's conference call. Thank you for your participation, and you may now disconnect.

我們的問答環節到此結束，今天的電話會議也到此結束。感謝您的參與，您現在可以斷開連接。