Co-Diagnostics Inc (CODX) 2025 Q1 法說會逐字稿

Thank you for standing by. My name is Cath, and I will be your conference operator today. At this time, I would like to welcome everyone to the Co-Diagnostics first-quarter 2025 earnings call. (Operator Instructions)

感謝您的支持。我叫 Cath，今天我將擔任您的會議主持人。現在，我歡迎大家參加 Co-Diagnostics 2025 年第一季財報電話會議。（操作員指示）

I would now like to turn the call over to Andrew Benson, Head of Investor Relations. Please go ahead.

現在我想將電話轉給投資者關係主管安德魯·本森 (Andrew Benson)。請繼續。

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.

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。

Earlier today, Co-Diagnostics released the financial results from the first quarter ended March 31, 2025. A copy of the press release is available on the company's website.

今天早些時候，Co-Diagnostics 發布了截至 2025 年 3 月 31 日的第一季財務業績。新聞稿副本可在該公司網站上查閱。

We will begin with management's prepared remarks and then open up the call to analyst Q&A. Before we begin, we would like to inform the 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, in addition to diagnostic test developments and timing for commencement of clinical evaluations.

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。在我們開始之前，我們想告知聽眾，Co-Diagnostics 在本次電話會議中所做的某些陳述並非歷史事實，而是前瞻性陳述。這包括有關該公司 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，此外還涉及診斷測試的開發和開始臨床評估的時間。

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.

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.

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。

In addition, the company may discuss certain non-GAAP financial measures during today's call. 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 reconciliation to the non-GAAP financial measures presented to their most comparable GAAP results.

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。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 的執行長 Dwight Egan。德懷特？

Thank you, Andrew, and good afternoon, everyone. Thank you for joining Co-Diagnostics first-quarter 2025 earnings call.

謝謝你，安德魯，大家下午好。感謝您參加 Co-Diagnostics 2025 年第一季財報電話會議。

During the first quarter, we continued to advance our Co-Dx PCR platform and associated test pipeline towards initiating clinical evaluations. I am proud of the work our team has done as we seek to bring our low-cost, rapid, and easy-to-use platform to the point-of-care market. Our mission at Co-Diagnostics is to increase the accessibility of affordable, high-quality diagnostics in the United States, India, and around the world, and we are nearing several important development milestones in pursuit of that vision, including the commencement of clinical studies for critical indications.

在第一季度，我們繼續推進我們的 Co-Dx PCR 平台和相關測試管道，以啟動臨床評估。我為我們團隊所做的工作感到自豪，我們致力於將低成本、快速且易於使用的平台引入即時醫療市場。Co-Diagnostics 的使命是提高美國、印度和世界各地獲得價格合理、高品質診斷服務的可及性，為了實現這一願景，我們即將實現幾個重要的發展里程碑，包括開始針對關鍵適應症的臨床研究。

As discussed in previous calls, the test pipeline for the new platform includes our diagnostic test for tuberculosis, or TB, COVID-19, four-plex respiratory panel, and eight-plex HPV panel. Over the past several years, these indications have developed into the most immediate opportunities for our unique technology and platform to impact the current standard of care and ultimately, patient outcomes.

如同先前的電話會議中所討論的，新平台的測試流程包括結核病（TB）、COVID-19、四重呼吸道檢測組和八重HPV檢測組的診斷測試。在過去的幾年裡，這些適應症已經發展成為我們獨特的技術和平台影響當前護理標準和最終患者治療結果的最直接機會。

Throughout our development efforts, we have been supported by several leading organizations who share in our passion for improving the global health infrastructure, including the Bill & Melinda Gates Foundation, SMART4TB, and the National Institute of Health's RADx Tech program. We remain highly focused on bringing our Co-Dx PCR platform to market, including several advancements that have been developed by our scientific, engineering, and software development teams. These new platform developments will be incorporated into our instrument and test kits as part of upcoming regulatory submissions, which we anticipate will drive operating and manufacturing efficiencies down the line for our current and future tests.

在我們的整個開發過程中，我們得到了一些領先組織的支持，他們與我們一樣熱衷於改善全球衛生基礎設施，其中包括比爾和梅琳達蓋茲基金會、SMART4TB 和美國國立衛生研究院的 RADx Tech 計劃。我們仍然高度專注於將我們的 Co-Dx PCR 平台推向市場，包括由我們的科學、工程和軟體開發團隊開發的幾項進展。這些新平台的開發將作為即將提交的監管文件的一部分納入我們的儀器和測試套件中，我們預計這將推動我們當前和未來測試的營運和製造效率。

The design for the augmented Co-Dx PCR COVID-19 test has been completed, and the test has undergone extensive verification testing. And we have full confidence in the test performance and stability. We plan to submit this updated version of our COVID-19 test to the FDA with a 510(k) application after updated clinical data has been collected. We are excited about the disruptive potential of our platform, and we'll continue to work tirelessly to introduce this powerful new diagnostic solution to the market.

增強型 Co-Dx PCR COVID-19 測試的設計已經完成，並且該測試已經過廣泛的驗證測試。我們對測試的性能和穩定性充滿信心。我們計劃在收集到更新的臨床數據後，透過 510(k) 申請向 FDA 提交 COVID-19 測試的更新版本。我們對我們平台的顛覆性潛力感到非常興奮，我們將繼續不懈地努力將這個強大的新診斷解決方案推向市場。

We are pleased by the work that we have done on our TB test so far this year. As discussed last quarter, we have already completed several preliminary analytical studies as well as testing on clinical samples to confirm performance. Moreover, we have identified instruments for the TB sample prep, which takes place prior to samples being added to the Co-Dx PCR MTB test cup, enabling an efficient and affordable workflow process. This step is crucial to the commercial launch and success of the TB test, and we believe we are in a great position as we prepare for upcoming clinical evaluations.

我們對今年迄今在結核病檢測方面所做的工作感到滿意。正如上個季度所討論的，我們已經完成了幾項初步分析研究以及臨床樣本測試以確認表現。此外，我們已經確定了用於結核病樣本製備的儀器，該儀器在將樣本添加到 Co-Dx PCR MTB 測試杯之前進行，從而實現了高效且經濟的工作流程。這一步驟對於結核病測試的商業化推出和成功至關重要，我們相信，在為即將到來的臨床評估做準備時，我們處於有利地位。

We are very excited about the potential of this testing solution to provide low-cost, high accuracy, real-time point-of-care diagnostics around the world to combat tuberculosis, which remains the leading global infectious disease killer. We see particular need for our TB test in locations like India, our top-priority market for TB testing, where we have significant experience, including regulatory, commercial, and manufacturing infrastructure through our joint venture, CoSara Diagnostics.

我們對這項檢測解決方案的潛力感到非常興奮，它有望在世界範圍內提供低成本、高精度、即時的即時診斷，以對抗仍然是全球頭號傳染病殺手的結核病。我們發現印度等地對我們的結核病檢測有特別的需求，印度是我們結核病檢測的首要市場，我們在當地擁有豐富的經驗，包括透過我們的合資企業 CoSara Diagnostics 獲得的監管、商業和製造基礎設施。

We expect to begin clinical evaluations in India and South Africa in the back half of 2025, gathering data that will be utilized to support regulatory submissions to the Central Drugs Standard Control Organization, or CDSCO, in India; and the South Africa Health Products Regulatory Agency, or SAHPRA, in Africa. In our clinical evaluation preparations, we continue to engage with local health officials in those regions and potential customers to evaluate the most effective and efficient commercialization strategy.

我們預計將於 2025 年下半年在印度和南非開始臨床評估，收集資料以支援向印度中央藥品標準控制組織 (CDSCO) 和非洲南非健康產品監管機構 (SAHPRA) 提交監管文件。在我們的臨床評估準備中，我們繼續與這些地區的當地衛生官員和潛在客戶合作，以評估最有效、最高效的商業化策略。

Elsewhere, our team continues to make significant progress on our four-plex respiratory panel, which has been developed with a grant support from the NIH's RADx Tech initiative. The test has been designed to deliver simultaneous real-time PCR test results for flu A and B, COVID-19, and RSV. Market research has identified a considerable amount of interest in this panel, which we believe is warranted by the burden these diseases place on everyday life in the United States and around the world.

此外，我們的團隊繼續在四重呼吸系統面板上取得重大進展，該面板是在 NIH 的 RADx Tech 計劃的資助下開發的。該測試旨在同時提供甲型流感和乙型流感、COVID-19 和 RSV 的即時 PCR 測試結果。市場調查發現，人們對該小組有相當大的興趣，我們認為，這些疾病對美國和世界各地的日常生活造成的負擔是合理的。

Core to our value proposition is the capability to provide de-identified data to health departments at the local, regional, national or international level to help track outbreaks of infectious diseases, thanks to the cloud-based analysis of tests performed on the Co-Dx PCR Pro. This situational awareness can provide health officials with key data and insights that could save lives and stop outbreaks.

我們的價值主張的核心是能夠向地方、地區、國家或國際層面的衛生部門提供去識別數據，以幫助追蹤傳染病的爆發，這要歸功於基於雲端的 Co-Dx PCR Pro 上執行的測試分析。這種態勢感知可以為衛生官員提供關鍵數據和見解，從而挽救生命並阻止疫情爆發。

In March, we completed a pre-submission to the FDA for the Co-Dx PCR Pro respiratory multiplex panel test kit. We have been assigned a reviewer and plan to initiate clinical evaluations for this assay in the second half of this year.

3 月份，我們向 FDA 完成了 Co-Dx PCR Pro 呼吸道多重檢測試劑盒的預先提交。我們已指派一名審查員，並計劃在今年下半年啟動該檢測的臨床評估。

Rounding out our pipeline, we continue to make good progress in preparing the eight-plex HPV panel for upcoming clinical evaluations. This development has been supported by a grant from the Bill & Melinda Gates Foundation as there is a vast need for HPV testing around the world.

完善我們的產品線，我們在為即將進行的臨床評估準備八重 HPV 檢測組方面繼續取得良好進展。由於全球對 HPV 檢測的需求龐大，此項開發得到了比爾和梅琳達蓋茲基金會的資助。

HPV is one of the most widespread and common sexually transmitted infections worldwide. Several human papillomavirus subtypes 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.

HPV 是全球最廣泛、最常見的性傳染感染之一。幾種人類乳突病毒亞型與子宮頸癌有關，子宮頸癌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。

Utilizing our Co-Primers technology, our HPV assay can simultaneously detect eight different high-risk HPV subtypes from a single cervical swab sample, providing an affordable and accessible tool for patients around the world.

利用我們的 Co-Primers 技術，我們的 HPV 檢測可以從單一子宮頸拭子樣本中同時檢測出八種不同的高危險 HPV 亞型，為世界各地的患者提供一種經濟實惠且易於使用的工具。

During the first quarter, our teams continued to generate performance data for our test, which has met or exceeded internal expectations. With support from our funding partners and key stakeholders, we look forward to initiation of our clinical evaluations, our regulatory submissions, and platform commercialization. We plan to initially pursue regulatory clearance in India for this test before moving to South Africa and other regions. Leveraging our existing footprint in India through CoSara, we believe we are uniquely positioned to serve the Indian market.

在第一季度，我們的團隊繼續為我們的測試產生效能數據，這些數據已經達到或超越了內部預期。在我們的資金合作夥伴和主要利益相關者的支持下，我們期待啟動臨床評估、監管提交和平台商業化。我們計劃先在印度尋求監管部門批准進行此項測試，然後再擴展到南非和其他地區。利用我們透過 CoSara 在印度的現有業務，我們相信我們擁有獨特的優勢來服務印度市場。

Before wrapping up, I would like to highlight events that Co-Diagnostics attended in the first quarter to build further awareness of the Co-Dx PCR platform. Following the inauguration of the oligonucleotide synthesis facility in December, in March, we hosted an HPV and cancer symposium to honor International HPV Awareness Day 2025 in India. This was hosted in collaboration with CoSara, which helped to set the stage as we prepare for analytical and clinical studies for our HPV test.

在結束之前，我想強調 Co-Diagnostics 在第一季參加的活動，以進一步提高人們對 Co-Dx PCR 平台的認識。繼 12 月寡核苷酸合成設施落成之後，3 月，我們在印度舉辦了 HPV 和癌症研討會，以紀念 2025 年國際 HPV 宣傳日。這是與 CoSara 合作舉辦的，它為我們準備 HPV 測試的分析和臨床研究奠定了基礎。

We also hosted a booth at BioUtah's Life Sciences Day on the Hill at the Utah State Capital Rotunda, which showcased our Co-Dx PCR platform for local health constituents and government officials. These events were well attended with a high level of engagement and interest in our platform. We welcome opportunities to engage with local and international potential customers and key stakeholders, which made these events a productive and collaborative experience for the company.

我們也在猶他州首府圓形大廳舉行的 BioUtah 生命科學日上設立了一個展位，向當地衛生選民和政府官員展示了我們的 Co-Dx PCR 平台。這些活動的參與人數眾多，對我們的平台的參與度和興趣都很高。我們歡迎與本地和國際潛在客戶和主要利益相關者接觸的機會，這使得這些活動成為公司富有成效的協作體驗。

To close out, I want to emphasize our commitment to achieving our regulatory objectives and to successfully launching the Co-Dx PCR Pro instrument and test kits to the world. Our team has been working diligently to advance our pipeline of diagnostic solutions, which has resulted in a successful first quarter. We are nearing several critical milestones, including clinical evaluations for all of the indications discussed here and a new submission to the FDA for COVID-19.

最後，我想強調我們致力於實現監管目標並成功向世界推出 Co-Dx PCR Pro 儀器和測試套件。我們的團隊一直在努力推進我們的診斷解決方案，並取得了第一季的成功。我們即將迎來幾個關鍵的里程碑，包括對這裡討論的所有適應症的臨床評估以及向 FDA 提交的針對 COVID-19 的新申請。

In India, we remain on track to complete the build-out of our manufacturing facility before the end of the year, which has already included an oligonucleotide synthesis facility inaugurated last December, giving us additional manufacturing capability in that region. We believe the Co-Dx PCR platform can revolutionize and set a new bar for the affordability, accessibility, and decentralization of infectious disease testing.

在印度，我們仍有望在年底前完成製造工廠的建設，其中包括去年 12 月啟用的寡核苷酸合成工廠，這將使我們在該地區擁有額外的製造能力。我們相信 Co-Dx PCR 平台可以帶來革命，並為傳染病檢測的可負擔性、可及性和分散化樹立新的標準。

I am very proud of the work of our team and look forward to another quarter of success.

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.

說完這些，我現在將電話轉給布萊恩，討論我們的財務表現。

Thanks, Dwight, and thanks to everyone who joined today's call. For the first quarter of 2025, total revenue decreased to $0.1 million as compared to $0.5 million in the prior-year same period. All revenue recognition during the first quarter came from product revenue.

謝謝，德懷特，也感謝今天參加電話會議的所有人。2025 年第一季度，總營收從去年同期的 50 萬美元下降至 10 萬美元。第一季的所有收入確認均來自產品收入。

Total operating expenses for the first quarter of 2025 decreased to $8.6 million from $10.5 million in the first quarter of 2024. Research and development expenses in the first quarter of 2025 were $4.9 million compared to $5.7 million during the first quarter of 2024.

2025 年第一季的總營運費用從 2024 年第一季的 1,050 萬美元降至 860 萬美元。2025 年第一季的研發費用為 490 萬美元，而 2024 年第一季為 570 萬美元。

For the first quarter of 2025, income before taxes was a loss of $7.5 million as compared to a loss of $9.3 million reported in the prior-year period. Net loss for the first quarter of 2025 was $7.5 million, or a loss of $0.24 per fully diluted share, compared to a net loss of $9.3 million, or a loss of $0.31 per fully diluted share in the prior-year period. Adjusted EBITDA was a loss of $7.4 million compared to an adjusted EBITDA loss of $8.4 million in the prior-year period.

2025 年第一季度，稅前收入虧損 750 萬美元，去年同期的虧損為 930 萬美元。2025 年第一季淨虧損為 750 萬美元，即每股完全攤薄虧損 0.24 美元，而去年同期淨虧損為 930 萬美元，即每股完全攤薄虧損 0.31 美元。調整後 EBITDA 虧損 740 萬美元，而去年同期調整後 EBITDA 虧損 840 萬美元。

We ended the quarter with $21.5 million in cash, cash equivalents, and marketable investment securities. We continue to manage our spend as we look to maintain a healthy balance sheet to position ourselves for a future commercial launch.

本季末，我們擁有 2,150 萬美元的現金、現金等價物和有價投資證券。我們將繼續管理我們的支出，以保持健康的資產負債表，為未來的商業發布做好準備。

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 financing, seeking additional grant funding, and through 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。我們計劃透過股權融資、尋求額外的撥款以及提高營運效率來滿足公司的資本需求。

In the near term, we are focused on progressing our development pipeline towards regulatory submission and are managing our allocation of time and resources accordingly. We are very excited about our continued progress and remain optimistic about 2025 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並提交監管部門，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 年以及我們測試流程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 our employees who work hard each day to progress our test pipeline and missions.

謝謝你，布萊恩。最後，我們要向 Co-Diagnostics 股東和我們的員工表示感謝，他們每天都在努力推動我們的測試流程和任務。

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) Yi Chen, H.C. Wainwright.

（操作員指示）Yi Chen，H.C. Wainwright。

This is Eduardo on for Yi. Just hoping to get a little bit more clarity on the time line for resubmission that you guys were planning on doing, I understand, for the COVID test and the state of that. And if there's anything else that would be required for that resubmission for the 510(k) application.

愛德華多替補易建聯上場。我理解，我只是希望能夠更清楚地了解你們計劃重新提交 COVID 測試的時間表及其狀態。以及重新提交 510（k）申請是否還有其他要求。

So thank you for the question. We have already completed the new design for our new version of the test. And we have done extensive verification on the test. The feedback we had originally received from the FDA on our previous submission surrounding the ability to monitor the shelf stability of one of our test components has been solved. And we are just getting ready to enter our clinical evaluations.

謝謝你的提問。我們已經完成了新版本測試的新設計。並且我們在測試中做了廣泛的驗證。我們之前提交的關於監控我們其中一個測試組件的貨架穩定性的能力的反饋已經解決。我們正準備進入臨床評估階段。

In this process, we have continued to enhance our platform's capabilities, and we're now able to incorporate new developments onto the instrument and test cups for the new COVID-19 test for our new submission, along with other tests in our pipeline. So we're confident in these enhancements, which we believe unlocks greater manufacturing and operational efficiencies for our new platform and the tests, we're now focused on assembling and preparing for this new submission, which will be substantially similar to our earlier submission, enhanced by the new data that will come from our clinical trial upcoming.

在此過程中，我們不斷增強平台的功能，現在我們能夠將新的開發成果融入新提交的 COVID-19 測試的儀器和測試杯中，以及我們正在進行的其他測試中。因此，我們對這些改進充滿信心，我們相信這些改進將為我們的新平台和測試帶來更高的製造和運營效率，我們現在專注於組裝和準備新的提交，它將與我們之前的提交基本相似，並通過我們即將進行的臨床試驗的新數據得到增強。

So we remain very positive on the functionality and quality of the test. We believe that the revised 510 application will increase the probability of a successful clearance. And so we're very far along in this process and don't anticipate that it will be a long time coming before we will commence our clinical trials.

因此，我們對測試的功能和品質仍然非常樂觀。我們相信修改後的510申請將增加成功清關的機率。因此，我們在這個過程中已經取得了很大進展，並且預計我們很快就會開始臨床試驗。

Got it. And do you have any specific date by which you expect to submit?

知道了。您預計提交的具體日期是什麼？

Sort of the governor of that is what the prevalence of COVID is in the world, in United States in particular. So for instance, if we ended up being ready to go to clinical trials but we weren't seeing a prevalence of COVID-19 at our test sites, we would hold on until we saw the amount of COVID infection that would be required to conduct an effective and efficient test.

某種程度上，這就是 COVID 在世界範圍內，尤其是在美國的流行情況。舉例來說，如果我們最終準備進行臨床試驗，但在測試地點沒有看到 COVID-19 的流行，我們就會堅持下去，直到看到進行有效和高效測試所需的 COVID 感染量。

So it's a little bit of a waiting game for when does COVID emerge. As you know, the history of COVID, it tends to have outbreaks that may, for instance, be caused by activities that get group settings together, Thanksgiving, holidays, ball games, those sorts of things. So we don't know exactly what the timing is because there are some exogenous events and characteristics that we have to pay attention to.

因此，這有點像是一場等待 COVID 何時出現的遊戲。正如你們所知，COVID 的歷史表明，它往往由群體聚集的活動、感恩節、假期、球類比賽等引起疫情爆發。因此，我們不知道確切的時間是什麼，因為有一些外部事件和特徵需要我們注意。

Got it. That's helpful. And regarding the other products that you are planning to launch in India and South Africa, do you have a timeline for that? And I don't know what the regulatory process or timeline for that is as well.

知道了。這很有幫助。關於您計劃在印度和南非推出的其他產品，您有時間表嗎？我也不知道這方面的監管流程或時間表是怎麼樣的。

So the best guidance I can give you on the other three tests, that would be our multiplex ABCR test, as we refer to it internally, COVID -- it includes COVID-19, it includes RSV, it includes flu A and flu B. That is also governed by the same kind of constraints that I mentioned with respect to COVID, and then there's the HPV test and the TB test. We expect all of those tests to be into clinical trials during the remainder of this year. They will commence clinical trials during the remaining part of 2025.

因此，關於其他三項測試，我能給您的最佳指導是我們的多重 ABCR 測試，我們內部稱之為 COVID - 它包括 COVID-19，包括 RSV，包括甲型流感和乙型流感。這也受到我在 COVID 方面提到的相同類型的限制的限制，然後是 HPV 測試和 TB 測試。我們預計所有這些測試都將在今年剩餘時間內進入臨床試驗階段。他們將在 2025 年剩餘時間內開始臨床試驗。

As you can appreciate, in places like India, we don't have any problem getting samples. So there's not a constraint with respect to the presence of HPV. HPV, India comprises roughly 25% of all HPV cases in the world. So we don't have an anticipation that we're going to have any trouble getting samples there.

如您所知，在印度這樣的地方，我們獲取樣品沒有任何問題。因此，對於 HPV 的存在沒有限制。HPV，印度約佔全球所有 HPV 病例的 25%。所以我們預計在那裡獲取樣品不會遇到任何問題。

And of course, in tuberculosis, it is the number one infectious disease killer on the planet. And India is certainly one of the epicenters of that. So we don't anticipate having any trouble getting those samples. So -- but other than that, from a date standpoint, they will all be entering the clinical trial phase during the rest of this calendar year.

當然，結核病是地球上頭號傳染病殺手。印度無疑是其中的一個中心。因此我們預計獲取這些樣本不會遇到任何問題。所以——但除此之外，從日期的角度來看，它們都將在今年剩餘時間內進入臨床試驗階段。

Got it, got it. That's really helpful. So broadly speaking, it's probable that the HPV and tuberculosis tests or trials might run a little bit quicker, leading to maybe an earlier launch. Is that a fair characterization?

明白了，明白了。這真的很有幫助。因此，從廣義上講，HPV 和結核病測試或試驗可能會運行得更快一些，從而可能提前推出。這是一個公正的描述嗎？

That is certainly a possibility. Largely, that stems from the ability to get samples at will basically. So keep in mind that all of these indications are currently undergoing important testing. We have manufactured hundreds of thousands of test cups in our facility, our manufacturing facility. So there's been a ton of work done getting ready for these clinical trials.

這當然是有可能的。很大程度上，這源自於隨意取得樣本的能力。因此請記住，所有這些跡象目前都在接受重要的測試。我們已經在我們的工廠，我們的製造工廠生產了數十萬個測試杯。為了準備這些臨床試驗我們已經做了大量的工作。

I would add, I think that our original submission with respect to COVID-19, the FDA did not have a problem with our instrument. They didn't have a problem with the clinical trial that was performed, which involved well over 800 different patients. We just wanted to fix the one internal positive control. So that was not something we had to really ever worry about again.

我想補充一點，我認為我們最初提交的有關 COVID-19 的文件，FDA 對我們的儀器沒有異議。他們對所進行的臨床試驗沒有任何問題，該試驗涉及 800 多名不同的患者。我們只是想修復一個內部陽性控制。所以我們真的不需要再擔心這個了。

And the same positive control that's RNA-based is also incorporated into the ABCR test. So we are on the lip of the cup of being ready to go into clinical trials and look forward to that very important step for us during the remainder of this year. And then it's on to regulatory submission and our initial commercialization launch.

並且基於 RNA 的相同陽性對照也被納入 ABCR 測試中。因此，我們即將做好進入臨床試驗的準備，並期待在今年剩餘時間內邁出這對我們來說非常重要的一步。然後是監管提交和我們的初步商業化發布。

Understood. And then just one final one, I guess, if I could. Obviously, do you have any idea for pricing and the gross margins for the device and the test cups? I imagine it would vary from geography, but if you could give maybe ballpark estimates if they're available.

明白了。如果可以的話，我想，我只想問最後一個問題。顯然，您對該設備和測試杯的定價和毛利率有什麼想法嗎？我想這會因地理位置而異，但如果有的話，您可以給出大概的估計。

Yeah. I think we have long talked about the cost of our instrument initially being in the $300 to $500 range. It kind of depends on how many people buy. And at scale, we know where our target is, at the lower end of that number, and we may begin our deployment at a little bit higher number as we scale up. But that's the sort of working number that we're looking for. It's not a guaranteed number, but that's what our target is.

是的。我想我們早就討論過我們的儀器的成本最初在 300 到 500 美元之間。這取決於有多少人購買。從規模來看，我們知道我們的目標在哪裡，也就是這個數字的下限，隨著規模的擴大，我們可能會從稍微高一點的數字開始部署。但這正是我們正在尋找的有效數字。這不是一個保證的數字，但這就是我們的目標。

And with respect to the test cartridges, as you have mentioned, you're right, it kind of depends on the geography. Low- and middle-income countries will have a lower-priced test, generally speaking, than in the developed world. So we've typically used the $15 to $20 per cup price in the developed world. And for diseases such as tuberculosis, we've used pricing that is lower than our primary competitors in places like India.

關於測試墨盒，正如您所提到的，您是對的，這有點取決於地理位置。一般來說，中低收入國家的測試費用比已開發國家低。因此，我們通常採用已開發國家每杯 15 至 20 美元的價格。對於結核病等疾病，我們採用的定價低於印度等地的主要競爭對手。

That's as much guidance, I think, as I can give you on that right now. And human papillomavirus is probably not as sensitive as TB.

我想，這就是我現在能給你的全部指引。而人類乳突病毒可能不像結核病那麼敏感。

And Eduardo, this is Brian. Just to add one little piece of information to that. We would expect in terms of margins that our margins on the device would be similar to the equipment that we sold in the past. And we'd expect that the tests are similar. The margins are going to be similar to the margins we've experienced when we've sold the lab-based tests in the past.

愛德華多，這是布萊恩。只需添加一點資訊即可。就利潤率而言，我們預計該設備的利潤率將與我們過去銷售的設備相似。我們期望測試結果類似。利潤將與我們過去銷售實驗室測試時的利潤相似。

Got it. So using all these past references for those. All right, really appreciate the answers and thanks for taking the questions.

知道了。因此，請使用所有這些過去的參考資料。好的，非常感謝您的回答，也感謝您回答這些問題。

Thank you. I'm not showing any further questions in the queue. Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect.

謝謝。我不會在隊列中顯示任何其他問題。女士們、先生們，今天的電話會議到此結束。感謝大家的加入。您現在可以斷開連線。