Co-Diagnostics Inc (CODX) 2025 Q3 法說會逐字稿

Hello, and thank you for standing by. My name is Tiffany, and I will be your conference operator today. At this time, I would like to welcome everyone to the Co-Diagnostics, Inc. third quarter 2025 earnings webcast. (Operator Instructions) I would now like to turn the call over to Andrew Benson, Head of Investor Relations.

您好，感謝您的耐心等待。我叫蒂芬妮，今天我將擔任你們的會議接線生。此時此刻，我謹代表 Co-Diagnostics 公司歡迎大家參加 2025 年第三季收益網直播。（操作員指示）現在我將把電話轉交給投資者關係主管安德魯·本森。

Andrew, please go ahead.

安德魯，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. Earlier today, Co-Diagnostics released financial results from the third quarter ended September 30, 2025. A copy of the press release is available on the company's website.

大家下午好。感謝各位參加今天的電話會議。今天連線 Co-Diagnostics 的有：執行長 Dwight Egan 和財務長 Brian Brown。今天早些時候，Co-Diagnostics 發布了截至 2025 年 9 月 30 日的第三季財務業績。新聞稿副本可在公司網站上查閱。

We will begin with management's prepared remarks and then open the call to analyst Q&A. 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.

我們將首先聽取管理層的準備好的發言，然後開放分析師問答環節。在開始之前，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。

In addition to diagnostic test developments and timing for commencement of clinical evaluations, 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.

除了診斷測試的開發和臨床評估的開始時間之外，這還包括有關公司 Co-Dx PCR 檢測平台的聲明，該平台需要獲得監管部門的批准和上市許可才能用於診斷用途，目前尚未出售。

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. 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.

實際結果可能與任何聲明中明示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聲明中的結果有重大差異的重要因素已在 Co-Diagnostics 向美國證券交易委員會提交的文件中詳細說明。Co-Diagnostics 不承擔任何義務，並明確聲明不承擔任何責任，以更新任何前瞻性聲明，以反映本次電話會議之後發生的事件或情況，或反映意外事件的發生。

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 reconciliations 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GAAP財務指標。這些非GAAP財務指標不應被視為GAAP結果的替代指標，而應與GAAP結果一起閱讀。我們建議您參閱本公司在本次電話會議前不久發布的獲利報告，其中包含非GAAP財務指標與其最可比較GAAP結果的調節表。

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

此時，我想把電話交給 Co-Diagnostics 的執行長 Dwight Egan。德懷特？

Thank you, everyone, for joining us today and for your continued support of Co-Diagnostics. As we head into the final stretch of the year, it is shaping up to be one of the most active and important times for our business. Over the past 45 days alone, we've shared several important updates, which are all part of our plan to position Co-Diagnostics for its next phase of growth.

感謝各位今天蒞臨現場，也感謝大家一直以來對Co-Diagnostics的支持。隨著我們進入今年的最後階段，這將是我們業務最活躍、最重要的時期之一。僅在過去 45 天裡，我們就分享了幾個重要的更新，這些都是我們為 Co-Diagnostics 進入下一個增長階段而製定的計劃的一部分。

Each of these steps brings us closer to our goal, building a stronger, more resilient Co-Diagnostics operationally, financially and strategically. Importantly, these developments are the effect of cumulative growth and every initiative that we are currently working on connects to a broader strategy designed to create lasting value for shareholders.

每一步都讓我們離目標更近一步，在營運、財務和策略上建立一個更強大、更有韌性的 Co-Diagnostics。重要的是，這些發展是累積成長的結果，我們目前正在進行的每一項措施都與旨在為股東創造持久價值的更廣泛策略息息相關。

Over the coming months, our team is focused on executing across four main growth pillars. First, we recently announced the engagement of Maxim Group to assist in identifying potential strategic alternatives for the company's Indian joint venture, CoSara Diagnostics, which may include a merger with a Special Purpose Acquisition Company, or SPAC, or similar entity listed on a US National Securities Exchange. We believe such a transaction may unlock value from our joint venture project in India and support our long-term funding strategy.

在接下來的幾個月裡，我們的團隊將專注於執行四大成長支柱。首先，我們最近宣布聘請 Maxim Group 協助公司尋找其在印度的合資企業 CoSara Diagnostics 的潛在策略選擇，其中可能包括與一家特殊目的收購公司 (SPAC) 或在美國國家證券交易所上市的類似實體合併。我們相信，這樣的交易可以釋放我們在印度的合資計畫的價值，並支持我們的長期融資策略。

Second, the CoMira joint venture with Arabian Eagle, which marks the next step in our international expansion and commercial footprint as we expand our presence in Saudi Arabia and 18 additional MENA nations.

其次，CoMira 與 Arabian Eagle 成立合資企業，標誌著我們在國際擴張和商業版圖拓展方面邁出了下一步，我們將擴大在沙烏地阿拉伯和另外 18 個中東和北非國家的業務。

Third, our AI business unit, which is driving innovation, operational efficiency and new data-driven opportunities. And finally, the initiation of our upcoming upper respiratory multiplex test clinical evaluations, which highlights our scientific leadership and reinforces our domestic credibility.

第三，我們的人工智慧業務部門正在推動創新、提高營運效率並創造新的數據驅動型機會。最後，我們即將啟動上呼吸道多重檢測臨床評估，凸顯了我們的科學領先地位，並鞏固了我們在國內的信譽。

Together, these initiatives form a complete and aligned strategy focused on financial strength, global reach, technological innovation and disciplined execution. This is how we are approaching the remainder of 2025 and preparing the foundation for 2026 and beyond. This period represents a key inflection point for Co-Diagnostics and reflects years of execution to reach this stage of momentum and readiness.

這些舉措共同構成了一個完整且協調一致的策略，重點在於財務實力、全球影響力、技術創新和嚴謹的執行。這就是我們應對 2025 年剩餘時間並為 2026 年及以後奠定基礎的方式。這段時期是 Co-Diagnostics 的關鍵轉折點，體現了多年來為達到目前的勢頭和準備狀態所付出的努力。

With that context in mind, let's begin with the first and most time-sensitive development, the SPAC. One of the most exciting updates is our planned CoSara SPAC transaction with Maxim Group. This is a major step that we believe can unlock real value for both our operations in India and for Co-Diagnostics as a whole.

考慮到上述背景，讓我們從第一個也是最迫切的發展——SPAC（特殊目的收購公司）開始。其中最令人興奮的進展之一是我們計劃與 Maxim Group 進行 CoSara SPAC 交易。我們相信，這項重大舉措能夠為我們在印度的業務以及整個 Co-Diagnostics 產業帶來真正的價值。

The funds raised in this transaction are expected to represent a significant infusion of growth capital for CoSara operations in India and to increase Co-Diagnostics' value as well. Preparation for the transaction is progressing according to plan, and we expect to share updates on this project over the next several weeks and months. Combined with recent fundraising activities, this transaction has the potential to provide both flexibility and financial stability as we move into 2026 and begin commercialization of the new platform.

預計此次交易籌集的資金將為 CoSara 在印度的業務成長注入大量資金，並提升 Co-Diagnostics 的價值。交易準備工作正按計劃進行，我們預計將在未來幾週和幾個月內分享有關該專案的最新進展。結合最近的融資活動，這項交易有可能為我們在 2026 年開始新平台的商業化進程中提供靈活性和財務穩定性。

This is a proactive step that has the potential to strengthen our balance sheet and create a clear path toward long-term sustainable value creation for our shareholders. I look forward to providing more updates on this transaction as they occur. Shifting focus, the next major component of our growth strategy is the CoMira joint venture. Our recently announced joint venture with Arabian Eagle Manufacturing has led to the formation of a new company named, CoMira Diagnostics, which, along with CoSara will stand as one of the cornerstones of our international expansion strategy.

這是一項積極主動的舉措，有可能增強我們的資產負債表，並為我們的股東創造長期可持續的價值創造之路。我將在此交易有進展時及時向大家提供最新消息。轉變關注重點，我們成長策略的下一個主要組成部分是 CoMira 合資企業。我們最近宣布與 Arabian Eagle Manufacturing 成立合資企業，成立了一家名為 CoMira Diagnostics 的新公司。該公司將與 CoSara 一起，成為我們國際擴張策略的基石之一。

The principles of Arabian Eagle ran the primary distributor in the Middle East and were instrumental in Kingdom of Saudi Arabia, or KSA, being one of the largest international markets for the company's Logix Smart Test. Under the terms of the definitive agreement signed in the KSA, we have established CoMira to localize our Co-Dx PCR platform and other PCR-related intellectual property across the Middle East and North Africa.

Arabian Eagle 的負責人經營著中東地區的主要分銷商，並且對沙烏地阿拉伯王國（KSA）成為該公司 Logix Smart Test 的最大國際市場之一起到了重要作用。根據在沙烏地阿拉伯簽署的最終協議條款，我們成立了 CoMira 公司，旨在將我們的 Co-Dx PCR 平台和其他與 PCR 相關的智慧財產權在中東和北非地區在地化。

The partnership covers 19 countries, creating a significant commercial footprint in a high-growth region. CoMira will be headquartered in Riyadh with a dedicated manufacturing and assembly facility designed to produce PCR tests for infectious diseases and other applications relevant to the region's healthcare needs. The venture will initially focus on local manufacturing and distribution of the Co-Dx PCR platform with plans to expand into custom assay development and AI-enhanced diagnostics.

該合作關係涵蓋 19 個國家，在高成長地區建立了重要的商業影響力。CoMira 的總部將設在利雅得，並設有專門的製造和組裝設施，旨在生產用於傳染病的 PCR 檢測以及其他與該地區醫療保健需求相關的應用。該合資企業初期將專注於 Co-Dx PCR 平台的在地化生產和分銷，並計劃擴展到客製化檢測開發和人工智慧增強診斷領域。

The initiative aligns with the KSA's Saudi Vision 2030, supporting technology localization, industrial diversification and regional healthcare innovation. The regulatory pathway is anchored in obtaining Saudi Food and Drug Authority, SFDA clearance to facilitate regional distribution and regulatory acceptance across other MENA markets. CoMira will combine Co-Diagnostics molecular testing technology with Arabian Eagle's expertise in regional operations, infrastructure and local market access.

該倡議與沙烏地阿拉伯的「沙烏地阿拉伯2030願景」一致，支持技術在地化、產業多元化和區域醫療保健創新。監管途徑以獲得沙烏地阿拉伯食品藥物管理局（SFDA）的批准為基礎，以促進區域分銷和在其他中東和北非市場的監管認可。CoMira 將 Co-Diagnostics 的分子檢測技術與 Arabian Eagle 在區域營運、基礎設施和本地市場准入方面的專業知識相結合。

The agreement marks a major step in localizing advanced molecular diagnostics within the Middle East and positions Co-Diagnostics as a strategic partner in regional public health resilience. This milestone demonstrates that our international growth strategy has advanced from concept to execution and reflects the strong high-value partnerships we continue to build globally.

該協議標誌著中東地區先進分子診斷技術在地化邁出了重要一步，並將 Co-Diagnostics 定位為區域公共衛生韌性的策略合作夥伴。這一里程碑表明，我們的國際成長策略已從概念發展到執行階段，並體現了我們持續在全球範圍內建立的強大而高價值的合作夥伴關係。

While this global initiative expands our reach outside the United States, we remain equally focused on commercialization and on advancing innovation through our AI business unit and other technology-driven initiatives. Another key part of our strategy is our new AI business unit, led by our Chief Technology and AI Officer, Christopher Thurston.

雖然這項全球計畫擴大了我們在美國以外的影響力，但我們仍然同樣專注於商業化，並透過我們的人工智慧業務部門和其他技術驅動型計畫來推進創新。我們策略的另一個關鍵部分是我們新成立的人工智慧業務部門，由我們的首席技術和人工智慧長克里斯托弗·瑟斯頓領導。

This team is bringing all our current and future AI projects under one umbrella, the Co-Dx Primer AI platform. Additionally, our AI business unit is designed to accelerate the development of proprietary AI-powered diagnostics, enhance data analytics and improve operational efficiency across the organization. Integrating AI into our workflows will enable faster, smarter and more scalable testing processes while minimizing human error and improving efficiency at the point of care.

該團隊正在將我們所有當前和未來的 AI 項目整合到一個平台——Co-Dx Primer AI 平台——之下。此外，我們的人工智慧業務部門旨在加速開發專有的人工智慧驅動的診斷技術，增強數據分析能力，並提高整個組織的營運效率。將人工智慧融入我們的工作流程，將能夠實現更快、更聰明、更具可擴展性的測試流程，同時最大限度地減少人為錯誤，並提高護理點的效率。

These tools will support real-time PCR diagnostics, advance Co-Primers design and optimization and automate interpretation to improve outcomes in both lab and field environments. Our AI models are also being designed to deliver predictive epidemiological insights, giving healthcare providers and public health authorities earlier warning signals and improve situational awareness during potential outbreaks.

這些工具將支援即時 PCR 診斷，推進共引子設計和最佳化，並實現結果自動解讀，從而改善實驗室和現場環境中的結果。我們的人工智慧模型還旨在提供預測性流行病學見解，為醫療保健提供者和公共衛生部門提供更早的預警訊號，並在潛在疫情爆發期間提高態勢感知能力。

Over time, the system is expected to leverage analytics from widespread deployment of the Co-Dx PCR Pro to anticipate disease patterns and possibly predict outbreaks before they occur. As necessary, some of these models will be built on a secure HIPAA-compliant cloud platform with a new business unit formed to integrate internal data, workflow orchestration and AI-driven analysis into a single cohesive framework.

隨著時間的推移，該系統有望利用 Co-Dx PCR Pro 的廣泛部署所帶來的分析結果，來預測疾病模式，並有可能在疫情爆發之前對其進行預測。必要時，其中一些模型將建構在符合 HIPAA 標準的安全雲端平台上，並成立一個新的業務部門，將內部資料、工作流程編排和 AI 驅動的分析整合到一個統一的框架中。

This initiative underscores our commitment to staying at the forefront of innovation by combining advanced AI technology with our proven PCR expertise. Importantly, this program will position Co-Diagnostics to participate in one of the most dynamic growth areas in healthcare technology while building valuable new intellectual property and data assets. This is not simply an upgrade to existing systems.

這項措施彰顯了我們致力於將先進的人工智慧技術與我們成熟的PCR技術相結合，從而保持在創新前沿的決心。重要的是，該計劃將使 Co-Diagnostics 能夠參與醫療保健技術領域最具活力的成長領域之一，同時建立有價值的新智慧財產權和數據資產。這並非對現有系統的簡單升級。

It is a transformational step that redefines what diagnostics can achieve in speed, accuracy and real-time intelligence. As we continue to innovate technologically, we are also executing scientifically through our flu A, B, COVID-19 and RSV multiplex test clinical evaluation program, which further validates our progress and credibility in core diagnostics.

這是一個變革性的進步，它重新定義了診斷在速度、準確性和即時智慧方面所能達到的水平。隨著我們在技術上不斷創新，我們也透過流感 A、B、COVID-19 和 RSV 多重檢測臨床評估計劃進行科學執行，這進一步驗證了我們在核心診斷方面的進展和信譽。

We are preparing to initiate clinical evaluations for the upper respiratory multiplex test in the immediate future, a key milestone for Co-Diagnostics. This test is designed to simultaneously detect flu A, flu B, COVID-19 and RSV, making it the most comprehensive respiratory panel in our portfolio. Test has been supported by a RADx Tech grant from the National Institutes of Health, or NIH, underscoring both the credibility and importance of this work.

我們正準備在不久的將來啟動上呼吸道多重檢測的臨床評估，這是 Co-Diagnostics 的一個重要里程碑。此檢測旨在同時檢測甲型流感、乙型流感、新冠病毒和呼吸道合胞病毒，使其成為我們產品組合中最全面的呼吸道疾病檢測項目。該測試得到了美國國立衛生研究院 (NIH) 的 RADx Tech 資助，凸顯了這項工作的可信度和重要性。

RADx Tech program was created to accelerate innovation in diagnostic testing and our participation validates the strength of our technology and its public health relevance. This trial represents the culmination of extensive planning and development and marks the first Co-Dx multi-pathogen test to enter human clinical evaluation. The upper respiratory panel addresses a critical need in the domestic market by combining accuracy, speed and multiplex capability within a single point-of-care platform.

RADx Tech 計劃旨在加速診斷測試領域的創新，我們的參與驗證了我們技術的實力及其對公共衛生的重要性。這項試驗代表了廣泛的規劃和開發的最終成果，標誌著首個進入人體臨床評估的 Co-Dx 多病原體檢測。上呼吸道檢測板將準確性、速度和多重檢測能力結合在一個即時檢測平台上，滿足了國內市場的關鍵需求。

And we are pleased to be delivering on our commitment to initiate clinical evaluations in this flu season. The data from this trial will be used to support future regulatory submissions and commercial readiness for the US market and potentially for regulatory submissions in other markets as well, such as the SFDA in parallel with the U2S FDA submission.

我們很高興能夠履行承諾，在本流感季啟動臨床評估。本試驗的數據將用於支持未來向美國市場提交監管申請和商業化準備，並有可能用於向其他市場提交監管申請，例如與向美國食品藥品監督管理局 (FDA) 提交 U2S 申請同時向美國國家食品藥品監督管理局 (SFDA) 提交申請。

Initiating this study is a major step forward for our domestic business and a meaningful validation of our scientific and technical leadership. This test has generated consistent interest from both investors and potential partners, particularly those focused on high-volume US respiratory testing demand.

啟動這項研究是我們國內業務向前邁出的重要一步，也是對我們科學技術領先地位的有力證明。這項測試引起了投資者和潛在合作夥伴的持續關注，尤其是那些關注美國呼吸系統檢測需求量大的投資者和潛在合作夥伴。

The global market size for infectious disease diagnostics is expected to grow to $73.56 billion by 2030, and the demand for rapid accurate point-of-care diagnostics is driving an expanded opportunity for multiplex tests in the infectious disease testing market. The largest single geographical market for these tests is in North America, although the market for respiratory infectious disease testing in the Middle East is also expanding.

預計到 2030 年，全球傳染病診斷市場規模將增長至 735.6 億美元，對快速準確的即時診斷的需求正在推動傳染病檢測市場中多重檢測的擴大機會。這些檢測的最大單一地理市場在北美，儘管中東的呼吸道傳染病檢測市場也不斷擴大。

This is largely influenced by substantial investments in the Kingdom of Saudi Arabia and the KSA's commitment to improving public health in alignment with the Saudi Vision 2030 program. This program represents a rigorous NIH-supported multiplex evaluation with strong commercial potential and is a key component in reinforcing our reputation for execution and reliability within the diagnostics industry.

這主要受到沙烏地阿拉伯王國的大量投資以及沙烏地王國為實現「沙烏地阿拉伯2030願景」而致力於改善公共衛生的承諾的影響。該計劃代表了美國國立衛生研究院 (NIH) 支持的嚴格多重評估，具有強大的商業潛力，是鞏固我們在診斷行業執行力和可靠性聲譽的關鍵組成部分。

In short, this milestone demonstrates Co-Diagnostics is executing, not just planning and delivering tangible scientific progress that supports both near-term and long-term growth. Looking at our other programs like Co-Dx PCR MTB or tuberculosis test and Co-Dx PCR HPV8-type multiplex test, both remain on track to initiate clinical evaluations before year-end, as stated in previous communications.

簡而言之，這一里程碑表明 Co-Diagnostics 不僅在計劃，而且在執行和交付切實的科學進步，從而支持近期和長期成長。再來看我們的其他項目，如 Co-Dx PCR MTB 或結核病檢測和 Co-Dx PCR HPV8 型多重檢測，正如先前溝通所述，這兩個項目都將繼續按計劃在年底前啟動臨床評估。

Both tests have been supported by grants from the Bill & Melinda Gates Foundation and are anticipated to significantly contribute to our international expansion ambitions and represent key components in our goals to provide gold standard solutions for unmet needs in various markets that are only anticipated to expand over the coming years.

這兩項測試都得到了比爾及梅琳達蓋茲基金會的資助，預計將為我們的國際擴張目標做出重大貢獻，並成為我們實現目標的關鍵組成部分，即為未來幾年預計會不斷擴大的各個市場中尚未滿足的需求提供黃金標準解決方案。

We believe that the introduction of competitively priced diagnostics into markets anxious to gain the upper hand against the spread of deadly and often devastating infections will position Co-Dx as a leader in innovation and point-of-care PCR diagnostics.

我們相信，向渴望在對抗致命且往往具有毀滅性的傳染病傳播方面佔上風的市場推出具有競爭力的診斷產品，將使 Co-Dx 成為創新和即時 PCR 診斷領域的領導者。

Taken together, the initiatives we have discussed today, including the CoSara SPAC transaction, the CoMira joint venture, the launch of our AI business unit, the imminent domestic clinical evaluations and the upcoming clinical evaluations of the other tests in our pipeline all reflect the significant progress Co-Diagnostics has made over the past several months.

綜上所述，我們今天討論的各項舉措，包括 CoSara SPAC 交易、CoMira 合資企業、人工智慧業務部門的成立、即將進行的國內臨床評估以及我們研發管線中其他測試即將進行的臨床評估，都體現了 Co-Diagnostics 在過去幾個月中取得的重大進展。

Each of these milestones strengthens a different part of our business from capital structure and international growth to innovation and scientific validation. Collectively, they demonstrate that our strategy is working, our execution is on track and our team remains focused on creating lasting value for shareholders.

這些里程碑中的每一個都加強了我們業務的不同方面，從資本結構和國際成長到創新和科學驗證。總而言之，這些都表明我們的策略正在奏效，我們的執行正在按計劃進行，我們的團隊將繼續專注於為股東創造持久價值。

Over the last two months, we also closed two strategic direct offerings totaling gross proceeds of $10.8 million. We are entering the next phase of growth from a position of strength, supported by a robust balance sheet, a growing pipeline and a clear path toward both near-term and long-term milestones.

在過去的兩個月裡，我們也完成了兩項策略性直接發行，總收益達 1,080 萬美元。我們正從強勁的地位進入下一個成長階段，這得益於穩健的資產負債表、不斷成長的業務儲備以及實現近期和長期里程碑的清晰路徑。

With that, I'll now turn the call over to Brian Brown, our Chief Financial Officer, to provide an update on our financial performance and outlook.

接下來，我將把電話交給我們的財務長布萊恩布朗，讓他介紹我們的財務表現和前景。

Thanks, Dwight, and thank you to everyone who joined today's call. For the quarter, total revenue was $0.1 million compared to $0.6 million in the same period last year. In the prior year period, revenue from grants represented approximately $0.4 million, while in Q3 2025, all revenue recognized came from product sales.

謝謝德懷特，也感謝今天參加電話會議的所有人。本季總收入為 10 萬美元，而去年同期為 60 萬美元。上一年同期，來自撥款的收入約為 0.4 億美元，而 2025 年第三季確認的所有收入均來自產品銷售。

Total operating expenses for Q3 2025 decreased to $7.1 million compared to $10.6 million in Q3 2024. This reduction reflects our continued focus on becoming more operationally efficient. Research and development expenses were $4.5 million compared to $4.9 million in the prior year comparable period.

2025 年第三季總營運支出減少至 710 萬美元，而 2024 年第三季為 1,060 萬美元。這一降幅體現了我們持續致力於提高營運效率的決心。研發費用為 450 萬美元，去年同期為 490 萬美元。

Net loss for Q3 2025 was $5.9 million or a loss of $0.16 per fully diluted share compared to a $9.7 million loss or $0.32 per fully diluted share in the same period last year. Adjusted EBITDA was a loss of $6.3 million in Q3 2025 compared to a loss of $8.8 million in Q3 2024. We ended the quarter with $11.4 million in cash, cash equivalents and marketable investment securities.

2025 年第三季淨虧損為 590 萬美元，即每股完全稀釋虧損 0.16 美元，去年同期淨虧損為 970 萬美元，即每股完全稀釋虧損 0.32 美元。2025 年第三季調整後 EBITDA 虧損 630 萬美元，而 2024 年第三季虧損 880 萬美元。本季末，我們持有現金、現金等價物及有價投資證券共1,140萬美元。

As always, we are carefully managing our spending to maintain a healthy balance sheet while positioning the company for commercialization. Throughout the year, we will continue to optimize our operating footprint to drive efficiency gains and cost savings. In addition to the strategies outlined by Dwight earlier, we plan to meet other capital requirements through a combination of equity and debt financing, additional grant funding and continued operational efficiencies.

和以往一樣，我們正在謹慎管理支出，以保持健康的資產負債表，同時為公司的商業化做好準備。今年，我們將繼續優化營運佈局，以提高效率並節省成本。除了德懷特先前概述的策略外，我們還計劃透過股權和債務融資、額外的撥款資金以及持續的營運效率來滿足其他資金需求。

We are also evaluating other financing structures to strengthen our financial position and maintain flexibility. In parallel, we continue to pursue grant funding opportunities to support the advancement of our Co-Dx PCR platform. In the near term, our focus remains on progressing our development pipeline, completing clinical evaluations and preparing for regulatory submissions.

我們也正在評估其他融資結構，以增強我們的財務狀況並保持靈活性。同時，我們繼續尋求資助機會，以支持我們Co-Dx PCR平台的進步。短期內，我們的重點仍是推動研發管線，完成臨床評估，並準備向監管機構提交申請。

We are allocating our resources and time strategically to support these priorities. Looking ahead, we are optimistic about multiple commercial launches expected in 2026 and the ongoing development within our test pipeline. I look forward to sharing additional updates and milestones on our next call.

我們正在策略性地分配資源和時間，以支持這些優先事項。展望未來，我們對 2026 年預計的多次商業發布以及測試流程中的持續開發持樂觀態度。我期待在下次通話中與大家分享更多最新進展和重要里程碑。

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

接下來，我將把時間交還給德懷特。

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. Let's now open the line up for questions. Operator?

謝謝你，布萊恩。最後，我們要感謝 Co-Diagnostics 的股東和員工，他們的持續奉獻和辛勤工作是我們實現 Co-Dx 願景最寶貴的資產之一。現在開始接受提問。操作員？

(Operator Instructions) Katherine Degen, H.C. Wainwright.

（操作說明）Katherine Degen，H.C. Wainwright。

This is Katherine on for Yi. My question centers around performance of CoSara and CoMira. For CoSara, are they meeting your performance expectations? And if not, what's causing that discrepancy? And how do you kind of expect CoMira to perform financially in comparison?

這裡是凱瑟琳為易報道。我的問題主要圍繞著 CoSara 和 CoMira 的性能。CoSara 的表現是否符合您的預期？如果不是，那是什麼原因造成了這種差異？那麼，你預計CoMira的財務表現會是如何呢？

Katherine, thank you for the question. With respect to the performance of both CoSara and CoMira, we're very pleased with the performance of both of those entities. Keep in mind that the CoMira entity is newly formed, and it was formed with leadership from previous interactions that we have had from a business standpoint with the distributors of our product in Saudi Arabia.

凱瑟琳，謝謝你的提問。就 CoSara 和 CoMira 的表現而言，我們對這兩家公司的表現都非常滿意。請記住，CoMira 實體是新成立的，其領導層是根據我們先前與沙烏地阿拉伯產品經銷商的業務互動而組成的。

Saudi Arabia has been consistently the largest international customer for Co-Diagnostics. And so it made a lot of sense for us to establish a joint venture where we could participate more actively in the forward-going opportunity in Saudi Arabia, especially as it revolves around the introduction of our new and revolutionary point-of-care device, the Co-Dx PCR Pro.

沙烏地阿拉伯一直是Co-Diagnostics最大的國際客戶。因此，對我們來說，成立一家合資企業，以便我們能夠更積極地參與沙烏地阿拉伯的未來發展機遇，就顯得非常有意義，尤其是在我們推出全新革命性即時檢測設備 Co-Dx PCR Pro 的情況下。

So they played a huge role in what we're doing and what we have been doing for the last several years at Co-Diagnostics, and we expect that they will be a wonderful partner to this joint venture in moving our agenda forward in what, again, has been our largest international customer.

因此，他們在我們 Co-Diagnostics 過去幾年所做的工作中發揮了巨大的作用，我們期望他們能夠成為我們合資企業的優秀合作夥伴，推動我們在我們最大的國際客戶那裡實現我們的目標。

With respect to CoSara, we have been involved in this joint venture with CoSara for about 8 years, we have established a real solid footprint in that country. We have sales personnel that cover largely the entire country. We have significant manufacturing operations there, mostly on the Sarabhai family properties where we established our first laboratory for manufacturing in 2019 when we cut the ribbon on that facility.

關於 CoSara，我們與 CoSara 的合資企業已經開展了大約 8 年，我們在該國建立了真正穩固的業務基礎。我們的銷售人員涵蓋了全國大部分地區。我們在那裡開展了大量的生產業務，主要位於薩拉拜家族的產業上。 2019 年，我們在那裡建立了第一個生產實驗室，並舉行了剪綵儀式。

And then last December, if you'll recall, we established on that same acreage, another more sophisticated property for the development of our oligonucleotides, which we can now produce there in country, and we'll continue to progress the manufacturing opportunity there so that they are manufacturing in connection with the Make it in India initiative of Prime Minister, Modi. They will be making the cups or the cartridges along with the instrumentation.

如果你還記得的話，去年 12 月，我們在同一塊土地上建立了另一個更先進的設施，用於開發我們的寡核苷酸，我們現在可以在那裡生產這些寡核苷酸，我們將繼續推進那裡的生產機會，以便他們能夠響應莫迪總理的「印度製造」倡議進行生產。他們將製作杯子或藥筒以及相應的儀器。

And so we're very pleased with the kind of market development that has occurred over there. Co-Diagnostics is a real fan of the leadership of the Sarabhai family, and the other scientists and workers have brought to our company in India.

因此，我們對那邊的市場發展感到非常滿意。Co-Diagnostics 非常欣賞 Sarabhai 家族的領導才能，以及他們為我們公司在印度帶來的其他科學家和員工。

We are well respected in India at the government level, in the academic area and in being able to supply our products to lots of different labs throughout the country. So we have developed a mature business there that is now capable to kind of go off and bring additional value, both to the people at CoSara and also the people at Co-Diagnostics. We think this will be a mutual benefit to both entities, and we're very enthusiastic about our prospects there.

我們在印度政府層級、學術界都享有很高的聲譽，並且能夠向全國許多不同的實驗室供應產品。因此，我們在那裡發展了一項成熟的業務，現在能夠獨立發展並為 CoSara 和 Co-Diagnostics 的人們帶來額外的價值。我們認為這對雙方都有利，我們對未來的發展前景非常樂觀。

Mike Okunewitch, Maxim Group.

Mike Okunewitch，Maxim集團。

Congrats on all the great progress. I guess to kick things off, I'd just like to see if you could talk a little bit about how a potential spinout of CoSara might interact with the MTB and HPV point-of-care programs. Is this something where they might be licensed over or you get some sort of distribution agreement signed? I'm just curious since it seems like there's quite a significant market in India for these programs.

祝賀你們取得的巨大進步。我想先拋磚引玉，請您談談 CoSara 的潛在衍生公司可能會如何與 MTB 和 HPV 即時護理計劃互動。這是可以透過授權許可的方式，還是需要簽署某種分銷協議？我只是好奇，因為這些項目在印度似乎有相當大的市場。

Well, thanks for the question, Mike. Tuberculosis is a disease that is the #1 killer in terms of infectious diseases in the world. And about 25% roughly of those deaths are coming from India. And a similar number is coming from Africa. And so between those two areas of the world, you have about half of all the deaths from -- coming from tuberculosis and tuberculosis is something that is curable.

謝謝你的提問，麥克。結核病是世界傳染病致死率排名第一的疾病。其中約有 25% 的死亡病例來自印度。來自非洲的數量也與之相近。因此，在世界這兩個地區，大約一半的死亡病例是由結核病造成的，而結核病是可以治癒的。

So it's really a shame not to be able to diagnose it effectively and get people treatment because it can be cured if it's caught in time and properly dealt with the therapeutics. So we have a very concrete plan in India with respect to CoSara capitalizing on being able to fill the gap between where they currently have access to PCR tests and where they need to have access.

所以，如果不能有效診斷並及時治療這種疾病，那真是太可惜了，因為如果及時發現並採用適當的治療方法，這種疾病是可以治癒的。因此，我們在印度製定了一個非常具體的計劃，即利用 CoSara 的優勢來填補他們目前能夠獲得 PCR 檢測的地方和他們需要獲得檢測的地方之間的差距。

I don't think there's any credible key opinion leader in the world that believes that the main -- that doesn't believe that the main solution to that problem of tuberculosis comes from replacing smear microscopy, which is about 125-year-old diagnostic tool, replacing that with molecular diagnostics is really what has to happen. And in order to make that happen, you have to have a product that has accessibility, that has the kind of accuracy that molecular has, and it also is something that you have to be able to get it down to the end of the row.

我認為世界上沒有任何一位可信的關鍵意見領袖會認為，解決結核病問題的主要方案不是用分子診斷取代塗片顯微鏡檢查（一種已有約 125 年歷史的診斷工具）。為了實現這一點，你必須擁有一個易於獲取的產品，一個具有分子級精度的產品，而且你還必須能夠將其精確地應用到每一行的末尾。

You can't make it too unaffordable. So we are the -- we -- in our mind, the perfect solution to being able to fill that gap between where they currently have -- and it's not a lot of places, but where they currently have molecular diagnostics and where it will be able to be taken by virtue of the new accessible, affordable and accurate solution that we have.

價格不能太高，否則買不起。所以，在我們看來，我們是填補目前分子診斷技術應用範圍與未來分子診斷技術應用範圍之間空白的完美解決方案——雖然應用範圍並不廣，但我們現在提供的這種新的、便捷的、價格合理的、準確的解決方案將使分子診斷技術得以應用。

So that applies both to tuberculosis and the human papillomavirus, which has a large presence in India. And I don't want you to think of India or Africa as being just TB and MTB markets. They have a lot of other issues that need to be addressed, and we intend to make those part of what we're addressing in these joint ventures and in the forthcoming transaction that we anticipate and hope for, for CoSara.

所以，這既適用於結核病，也適用於在印度廣泛流行的人類乳突病毒。我不想讓你們認為印度或非洲只是自行車和山地自行車市場。他們還有很多其他問題需要解決，我們打算將這些問題納入我們正在透過這些合資企業以及我們預期和希望的CoSara即將進行的交易中來解決的問題範圍。

Mike, if I can add something, this is Brian. We are talking about different structures internally and what this might look like, but we don't have anything concrete to share to the market, and we will as we move forward in the process.

麥克，如果我能補充一點的話，我是布萊恩。我們正在內部討論不同的組織結構及其可能的樣子，但我們目前還沒有任何具體資訊可以與市場分享，隨著流程的推進，我們會陸續公佈。

I appreciate the additional color here. I did want to follow up just on the angle of affordability and in particular, for the PCR Pro, I want to see if you could give a little bit more color on how you're actually able to reach a price point that is so much more affordable than your competitors. Does this have something to do with Co-Primers allowing you to use a more -- less complex device? Any additional clarity you could provide on that would be helpful.

我喜歡這裡增添的色彩。我想就價格實惠這一點再追問一下，特別是對於 PCR Pro，我想看看您能否更詳細地說明一下，您是如何做到價格比競爭對手實惠得多的。這是否與共引子使您能夠使用更簡單的設備有關？如果您能就此提供更多解釋，將不勝感激。

Again, an excellent question, Mike. And I think one of the reasons that we're able to produce a product at the price point that we've done is that's what we set out to do initially. Shortly after the COVID pandemic kicked in, we looked forward saying, where is this going to go? And we brought in a very, very good team of engineers that -- and scientists with the express idea that they would create a product that could have a price point potentially as low as about $300 to $500 at scale.

麥克，你又問了個好問題。我認為我們能夠以這樣的價格生產產品的原因之一，就是因為這正是我們最初就打算做的事情。新冠疫情爆發後不久，我們展望未來，不禁會問：未來會怎樣？我們引進了一支非常非常優秀的工程師和科學家團隊，他們的明確目標是創造一種產品，使其規模化生產的價格能夠低至 300 至 500 美元左右。

And that's been our goal from the beginning. And one of the remarkable things about the research and development of this product is that in the large measure, we've been able to keep a lid on what we think we will be able to produce this for at scale. And so as to whether other companies, why they haven't been able to do this, I think some of that has to do with the fact that they were making boxes before we even existed.

從一開始，這就是我們的目標。該產品研發過程中最值得稱道的一點是，在很大程度上，我們能夠控制住我們認為能夠大規模生產該產品的成本。至於其他公司為什麼沒能做到這一點，我認為部分原因在於，他們在我們成立之前就開始生產包裝盒了。

And so they didn't really come at it with a fresh open, clean slate like we did. And so we had certain important discrete goals that we wanted to accomplish as we set out to engineer both scientifically and mechanically this wonderful device. Of course, Co-Primers play a role in the effectiveness of the assays, but that -- the Co-Primer advantages revolve mainly around its ability to multiplex.

所以他們不像我們一樣，是以全新的、開放的心態來對待這件事的。因此，我們在著手從科學和機械兩方面設計這個奇妙的設備時，有一些重要的、具體的目標想要實現。當然，共引子在檢測的有效性中發揮作用，但共引子的優勢主要在於其多重檢測能力。

So for instance, when you look at the human papillomavirus, this is an 8-plex test for certain specific cancer markers associated with human papillomavirus, plus a ninth marker that is a human DNA control. So that's where Co-Primers kick in. They allow us to do this sort of multiplexing in a class by ourselves because of the way Co-Primers get rid of the formulation of primer-dimers.

例如，以人類乳突病毒為例，這是一個針對與人類乳突病毒相關的某些特定癌症標記的 8 重檢測，外加一個人類 DNA 對照標記。所以，這就是輔助引子發揮作用的地方。由於共引子消除了引子二聚體的形成，因此我們可以在課堂上自行進行這種多重化。

So I think that's the kind of guidance I could give you and the information about why we've been able to hold the price line. And if you can't make the product at a price point that's relevant to the people that you're trying to serve, it doesn't matter. So we've really held the lid on that. We're excited to take it into the market. There's a huge gap.

所以，我認為這就是我能給你們的指導，以及我們能夠維持物價水準的原因。如果你無法將產品的價格控制在目標客群可接受的範圍內，那就毫無意義。所以，我們一直對此事嚴加保密。我們非常期待將它推向市場。差距巨大。

Absolutely. And then one more for me, if you don't mind, and I'll hop back into the queue. When looking at the CoMira JV in Saudi Arabia and the Middle East, are there any particular products, particularly from the PCR Pro that you believe are most relevant for that market?

絕對地。如果你不介意的話，再給我來一個，然後我就重新排隊。在考察 CoMira 在沙烏地阿拉伯和中東的合資企業時，您認為有哪些產品，特別是 PCR Pro 產品，最適合該市場？

I believe that all of our current pipeline are very relevant to the CoMira market. It's not just tuberculosis and HPV. It also includes the number one problem in infectious disease. It's not the most deadly, but it's the most cases, and that's the upper respiratory. So our flu A, B plus COVID plus RSV is a very, very important test for that market as well.

我認為我們目前的所有產品線都與CoMira市場非常相關。不只是肺結核和人類乳突病毒。它也包括傳染病方面的第一大問題。雖然它不是最致命的，但病例最多，那就是上呼吸道感染。因此，我們的甲型流感、B型流感、新冠病毒和呼吸道合胞病毒檢測對於該市場來說也是一項非常非常重要的檢查。

And then that's just the beginning. We'll continue to develop more and more.

而這只是個開始。我們將繼續不斷發展壯大。

That concludes our question-and-answer session. Ladies and gentlemen, this concludes today's call. Thank you all for joining. You may now disconnect.

我們的問答環節到此結束。女士們、先生們，今天的電話會議到此結束。感謝各位的參與。您現在可以斷開連線了。