bioAffinity Technologies Inc (BIAF) 2022 Q4 法說會逐字稿

Good morning, and welcome to the bioAffinity Technologies Fourth Quarter 2022 Financial Results Conference Call. (Operator Instructions) Please note this event is being recorded.

早安，歡迎參加 bioAffinity Technologies 2022 年第四季財務業績電話會議。 （操作員指示）請注意，此事件正在被記錄。

I would now like to turn the conference over to Julie Anne Overton, Director of Corporate Communications. Please go ahead.

現在，我想將會議交給企業傳播總監 Julie Anne Overton。請繼續。

Thank you, operator. Good morning, everyone, and welcome to today's conference call to discuss bioAffinity Technologies fourth quarter and full year 2022 financial results and our recent business progress.

謝謝您，接線生。大家早上好，歡迎參加今天的電話會議，討論 bioAffinity Technologies 2022 年第四季和全年財務業績以及我們最近的業務進展。

Please note that certain information discussed during today's call is covered under the safe harbor provision of the Private Securities Litigation Reform Act. We caution listeners that bioAffinity Technologies management will be making forward-looking statements and that actual results may differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the company's business.

請注意，今天電話會議中討論的某些資訊屬於《私人證券訴訟改革法案》安全港條款的涵蓋範圍。我們提醒聽眾，bioAffinity Technologies 管理層將做出前瞻性陳述，並且由於與公司業務相關的風險和不確定性，實際結果可能與這些前瞻性陳述明示或暗示的結果存在重大差異。

These risks and uncertainties are detailed in and are qualified by the cautionary statements contained in bioAffinity Technologies press releases and SEC filings. This conference call contains time-sensitive information that is accurate only as of the date of the live broadcast today, April 3, 2023. bioAffinity Technologies undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call, except as required by law.

這些風險和不確定性在 bioAffinity Technologies 新聞稿和 SEC 文件中包含的警告聲明中有詳細說明，並且受到其限制。本次電話會議包含時間敏感訊息，這些資訊僅在今天（2023 年 4 月 3 日）現場直播之日準確無誤。除非法律另有規定，否則 bioAffinity Technologies 不承擔修改或更新任何前瞻性陳述以反映本次電話會議日期之後的事件或情況的義務。

I would like to now turn the call over to Maria Zannes, President and Chief Executive Officer of bioAffinity Technologies. Maria?

現在，我想將電話轉給 bioAffinity Technologies 總裁兼執行長 Maria Zannes。瑪麗亞？

Thank you, Julie Anne, and thank you to our listeners for joining us today. In terms of structure for today's call, first, I will provide an overview of the market opportunity we are targeting with CyPath Lung and the urgency of addressing the unmet medical need for the detection of lung cancer at early stage.

謝謝你，朱莉安妮，也感謝我們的聽眾今天的收聽。就今天電話會議的結構而言，首先，我將概述我們透過 CyPath Lung 瞄準的市場機會以及解決早期肺癌檢測未滿足的醫療需求的緊迫性。

Second, I will map out our commercial growth strategy, which begins with the limited launch of CyPath Lung in Texas that is designed to build and evaluate our marketing program, and help us ensure each step in the care pathway is efficient and effective, before expanding our footprint beyond Texas and potentially beyond lung cancer. We also will be seeking FDA clearance for CyPath Lung as a Class II IVD medical device. And as innovation has led to invention, we will be strengthening our patent portfolio.

其次，我將規劃我們的商業成長策略，首先在德克薩斯州有限推出 CyPath Lung，旨在建立和評估我們的行銷計劃，並幫助我們確保護理途徑中的每一步都是高效和有效的，然後將我們的足跡擴展到德克薩斯州以外，甚至可能擴展到肺癌以外的領域。我們還將尋求 FDA 批准 CyPath Lung 作為 II 類 IVD 醫療設備。隨著創新帶來發明，我們將加強我們的專利組合。

And third, Michael Edwards, our Chief Financial Officer, will provide an update on the company's financial position and capital strategy. We will then conclude with Michael, Julie Anne and me available to answer your questions.

第三，我們的財務長 Michael Edwards 將介紹公司財務狀況和資本策略的最新情況。最後，我們和邁克爾、朱莉安妮將回答您的問題。

But first, let me address the need for early lung cancer diagnosis. Our mission at bioAffinity Technologies is to detect cancer at an early stage because simply put, earlier diagnosis leads to better clinical outcomes and increases the patient's long-term survival. The need for early lung cancer detection is crucial.

但首先，讓我先談談早期肺癌診斷的必要性。 bioAffinity Technologies 的使命是在早期發現癌症，因為簡單地說，早期診斷可以帶來更好的臨床結果並提高患者的長期存活率。早期檢測肺癌至關重要。

Lung cancer is the leading cause of cancer-related deaths worldwide. And this is largely due to the fact that people often show no symptoms of lung cancer until the disease has progressed to advanced stages, such as Stage 4, at which point 5-year survival is only around 5%.

肺癌是全球癌症死亡的主要原因。這主要是因為，肺癌患者往往在病情進展至晚期（如第 4 期）時才出現任何症狀，此時 5 年存活率僅為 5% 左右。

However, when lung cancer is detected early, the prospects for successful treatment and even cure are significantly higher. Finding lung cancer at Stage 1, for example, and treating it can result in a 10-year survival rate of greater than 90%. This differential is where CyPath Lung takes aim and intends to make an impact.

然而，如果早期發現肺癌，成功治療甚至治癒的可能性就會大大提高。例如，在第一階段發現肺癌並進行治療可使10年存活率達到90%以上。這種差異正是 CyPath Lung 的目標，並打算產生影響。

Moreover, early lung cancer detection also reduces the cost of treatment and the need for additional tests. Treating lung cancer in advanced stages requires more aggressive treatments and hospitalization, both of which can significantly increase the cost of patient care.

此外，早期發現肺癌還可以減少治療費用和額外檢查的需要。晚期肺癌的治療需要更積極的治療和住院治療，這兩者都會顯著增加患者的照護成本。

Our first diagnostic test is called CyPath Lung. The test is sold as a laboratory developed test by our partner, Precision Pathology Services, a well-established CAP CLIA clinical laboratory. CyPath Lung is cost-effective, noninvasive, patient-friendly with at-home sample collection that enables physicians to more confidently distinguish between patients, who will likely benefit from timely intervention from those who should continue annual screening by low-dose CT.

我們的第一個診斷測試稱為 CyPath Lung。該測試由我們的合作夥伴 Precision Pathology Services（著名的 CAP CLIA 臨床實驗室）作為實驗室開發的測試出售。 CyPath Lung 具有成本效益、非侵入性、患者友好的特點，可以在家中採集樣本，使醫生能夠更自信地區分患者，哪些患者可能受益於及時幹預，哪些患者應繼續接受低劑量 CT 年度篩檢。

Low-dose CT is the standard of care for screening patients at high risk for lung cancer. Screening can significantly increase survival by finding early-stage cancer. So screening is essential to lower the death rate of lung cancer. But the process can be improved.

低劑量CT是篩檢肺癌高風險患者的標準治療方法。篩檢可以發現早期癌症，從而顯著提高存活率。因此篩檢對於降低肺癌死亡率至關重要。但這個過程可以改進。

Screening has a low positive predictive rate of 3.8%. And that means that only 4 out of 100 people who get a positive result from screening actually have lung cancer. By using CyPath Lung in conjunction with screening, we improve that positive predictive value, resulting in fewer unnecessary diagnostic procedures, earlier cancer detection and a reduction in health care costs.

篩檢的陽性預測率較低，僅 3.8%。這意味著，在篩檢結果呈陽性的 100 人中，只有 4 人實際上患有肺癌。透過結合篩檢使用 CyPath Lung，我們提高了陽性預測值，從而減少不必要的診斷程序、更早發現癌症並降低醫療成本。

We bring confidence and certainty to the diagnostic process. After a positive screening result, CyPath Lung efficiently stratified patients into 1 of 2 risk groups. Patients deemed likely to have lung cancer can proceed to more invasive and costly follow-up, while those deemed unlikely would continue imaging surveillance in accordance with the standard of care.

我們為診斷過程帶來信心和確定性。篩檢結果呈陽性後，CyPath Lung 會有效地將患者分層為 2 個風險組中的 1 個。被認為可能患有肺癌的患者可以接受更具侵入性和更昂貴的隨訪，而那些被認為不太可能患有肺癌的患者將繼續按照護理標準進行影像監測。

The physician receives actionable results informing him or her that CyPath Lung has detected the presence of lung cancer or has not. Results also include a numerical score. So physicians have more information in addition to the binary yes or no answer. We are beginning to test market CyPath Lung in Texas, and we are creating our brand. bioAffinity Technologies is based in San Antonio. And so we started our commercial rollout close to home, making sure we have everything right before expanding our footprint.

醫生會收到可操作的結果，告知他或她 CyPath Lung 是否檢測到肺癌的存在。結果還包括數字分數。因此，除了二元的「是」或「否」答案之外，醫生還擁有更多資訊。我們正開始在德克薩斯州試水 CyPath Lung 市場，並且正在創建我們的品牌。 bioAffinity Technologies 總部位於聖安東尼奧。因此，我們開始在家中附近進行商業推廣，確保在擴大業務範圍之前一切準備就緒。

The limited launch in Texas is designed to build and evaluate our marketing program and help us ensure each step in the care pathway is efficient and effective. From the initial order by physicians to patients' sputum collection and processing to generating and delivering the patient report we will build upon feedback from this test market find future positioning and develop our strategic insight for our CyPath Lung test. We are very pleased to be working with Havas Health & You and Trinity Life Sciences, 2 global leaders in health care marketing. They are developing our brand, our messaging and our strategic marketing plan to optimize commercial success.

在德克薩斯州的有限發布旨在建立和評估我們的行銷計劃，並幫助我們確保護理途徑中的每一步都是高效和有效的。從醫生的最初醫囑到患者的痰液收集和處理，再到產生和提交患者報告，我們將根據該測試市場的反饋找到未來的定位，並為我們的 CyPath 肺部測試制定戰略洞察力。我們非常高興能與 Havas Health & You 和 Trinity Life Sciences 這兩家全球醫療保健行銷領域的領導者合作。他們正在開發我們的品牌、資訊和策略行銷計劃，以優化商業成功。

In addition to building our path to a staged nationwide U.S. expansion, we've begun work towards commercializing CyPath Lung in the European Union, where there are an estimated 34 million smokers at high risk. One of the most impactful accelerants for driving sales can be FDA clearance of CyPath Lung as an in vitro diagnostic. We are finalizing the design and preparing a presubmission package to FDA.

除了在美國全國範圍內分階段推進擴張之外，我們還開始致力於在歐盟推行 CyPath Lung 商業化，據估計，歐盟有 3,400 萬高風險吸菸者。推動銷售的最有效促進劑之一可能是 FDA 批准 CyPath Lung 作為體外診斷產品。我們正在完成設計並準備向 FDA 提交的預提交資料。

Agency approval, if and when received, would enable us to directly market to physicians and their patients. And we are finalizing the design of a planned 1,800 patient pivotal trial, so that we can submit a presubmission package and launch the trial this year. Among other measures of accuracy, this longitudinal clinical diagnostic study will establish the sensitivity, specificity, positive predictive value and negative predictive value of CyPath Lung and will likely require 3 years.

如果獲得機構批准，我們將能夠直接向醫生及其患者推銷產品。我們正在最終確定一項計劃中的 1,800 名患者關鍵試驗的設計，以便我們可以提交預提交材料並在今年啟動試驗。除其他準確性措施外，這項縱向臨床診斷研究將確定 CyPath Lung 的敏感性、特異性、陽性預測值和陰性預測值，可能需要 3 年時間。

As ambitious as it sounds, our mission is even more than becoming a leader in the early-stage lung cancer diagnostic market. We have begun research to expand beyond that and see significant potential in the development of automated analysis to be used with flow cytometry technology. We are working to design noninvasive diagnostic tests for detecting and monitoring additional lung diseases, the first of which is Chronic Obstructive Pulmonary Disease, or COPD.

儘管聽起來雄心勃勃，但我們的使命不僅僅是成為早期肺癌診斷市場的領導者。我們已經開始進行超越這一範圍的研究，並看到了與流式細胞儀技術結合使用的自動化分析的巨大發展潛力。我們正在致力於設計非侵入性診斷測試，以檢測和監測其他肺部疾病，其中第一種是慢性阻塞性肺病（COPD）。

COPD is the fourth leading cause of death, representing another multibillion-dollar market opportunity for our growing platform. Innovation is a hallmark of bioAffinity Technologies. Our R&D efforts brought CyPath Lung to market and our ongoing research continues to reduce costs and improve accuracy.

慢性阻塞性肺病 (COPD) 是第四大死因，這為我們不斷發展的平台帶來了另一個價值數十億美元的市場機會。創新是 bioAffinity Technologies 的標誌。我們的研發努力將 CyPath Lung 推向市場，我們正在進行的研究繼續降低成本並提高準確性。

In the past year, our discoveries have led to significant publications in scientific journals. Last week, we announced publication in the peer-reviewed journal of visualized experiments of an article describing compensation beads we engineered that improve precision, lower the cost and accelerate sample processing in our AI developed flow cytometry platform.

在過去的一年裡，我們的發現已在科學期刊上發表重要論文。上週，我們宣佈在同行評審的可視化實驗期刊上發表了一篇文章，介紹了我們設計的補償珠，它可以提高精度、降低成本並加速我們 AI 開發的流式細胞儀平台的樣品處理。

In January, we published results of our clinical trial for CyPath Lung, reporting that our test achieved 92% sensitivity and 87% specificity in detecting lung cancer in people at high risk who had small lung nodules, less than 20 millimeters.

今年 1 月，我們公佈了 CyPath Lung 臨床試驗的結果，報告指出我們的測試在檢測肺結節小於 20 毫米的高危險群的肺癌方面實現了 92% 的敏感性和 87% 的特異性。

Building awareness of our company and our technologies within the scientific and medical communities helps us to set the stage for our future plans in diagnostics, as well as our longer-term plans for developing therapeutics. We are still in the early innings of establishing the value of bioAffinity Technologies and CyPath Lung for the early detection of lung cancer and in establishing our company as a leader in flow cytometry-based diagnostics.

在科學界和醫學界提高對我們公司和我們技術的認識有助於我們為未來的診斷計劃以及開發治療學的長期計劃奠定基礎。我們仍處於確立 bioAffinity Technologies 和 CyPath Lung 對於肺癌早期檢測的價值以及確立我們公司作為基於流式細胞儀的診斷領域的領導者地位的早期階段。

I'm proud of our company's, many accomplishments, including during these first few months as a public company. And there's so much potential for our team to address in the massive unmet medical need of early diagnosis for an estimated 18 million Americans at high risk for lung cancer. I look forward to continuing to share further updates with you.

我為我們公司所取得的諸多成就感到自豪，包括作為一家上市公司在頭幾個月所取得的成就。對於大約 1800 萬肺癌高風險美國人而言，我們的團隊在早期診斷方面有巨大的潛力可以滿足他們巨大的未滿足的醫療需求。我期待繼續與您分享進一步的更新。

But for now, I'll turn the presentation over to Michael Edwards, our Chief Financial Officer, to review our financial results for the quarter and the year. Michael?

但現在，我將把演講交給我們的財務長 Michael Edwards，來回顧我們本季和今年的財務表現。麥可？

Thank you, Maria, and good morning, everyone. I will review the key financial results for the fourth quarter and full year 2022 and touch base on our cash position.

謝謝你，瑪麗亞，大家早安。我將回顧 2022 年第四季和全年的主要財務業績，並了解我們的現金狀況。

Starting with the fourth quarter, revenue for the fourth quarter of 2022 was approximately $2,500 compared with no revenue for the prior period. As a reminder, our revenue is derived exclusively from the royalties for CyPath Lung currently being sold through our partner and licensee Precision Pathology Services.

從第四季開始，2022 年第四季的收入約為 2,500 美元，而上一期沒有收入。提醒一下，我們的收入完全來自於目前透過我們的合作夥伴和授權持有者 Precision Pathology Services 銷售的 CyPath Lung 的特許權使用費。

Research and development expenses were $429,000 for the fourth quarter of 2022 compared with $318,000 for the comparable period in 2021. General and administrative expenses were $1.2 million for the fourth quarter of '22 compared with $290,000 for the comparable period in 2021.

2022 年第四季的研發費用為 429,000 美元，而 2021 年同期為 318,000 美元。 2022 年第四季的一般及行政費用為 120 萬美元，而 2021 年同期為 29 萬美元。

Net loss for the fourth quarter of 2022 was $1.7 million compared with a net loss of $5.6 million for the comparable period in 2021. The difference is primarily attributed to a decrease in interest expense in the change in the fair value of our convertible notes.

2022 年第四季的淨虧損為 170 萬美元，而 2021 年同期的淨虧損為 560 萬美元。差異主要歸因於我們的可轉換票據公允價值變動中的利息費用減少。

Moving to our full year financial results. Revenue for 2022 was approximately $5,000 compared with no revenue in 2021. Research and development expenses were $1.1 million in 2022 compared with $1 million in 2021. The increase is primarily due to higher personnel, legal and research costs, partially offset by lower stock-based compensation expense.

轉向我們的全年財務表現。 2022 年的收入約為 5,000 美元，而 2021 年沒有收入。 2022 年研發費用為 110 萬美元，而 2021 年為 100 萬美元。成長的主要原因是人員、法律和研究成本增加，但股票薪酬費用降低部分抵消了這一增長。

General and administrative expenses were $2.7 million in 2022 compared with $1.1 million in 2021. The increase was primarily due to higher consulting, legal, patent and professional fees as we prepared for our IPO, and the reporting requirements of a public company. The increase was also attributed to higher stock-based compensation expense as well as hiring-related expenses to support the commercial launch of CyPath Lung.

2022 年一般及行政開支為 270 萬美元，而 2021 年為 110 萬美元。增加的主要原因是我們在準備 IPO 以及上市公司的報告要求時，諮詢、法律、專利和專業費用增加。這一增長也歸因於更高的股票薪酬費用以及用於支持 CyPath Lung 商業發布的招聘相關費用。

Net loss for 2022 was $8.2 million or $1.81 per share compared with a net loss for 2021 of $6.3 million or $2.36 per share. Cash and cash equivalents as of December 31, 2022, were $11.4 million. On September 6, bioAffinity Technologies raised net proceeds of approximately $6 million from an IPO of 1.3 million units, each unit consisting of 1 share common stock, 1 tradable warrant to purchase 1 share of common stock and 1 nontradable warrant.

2022 年淨虧損為 820 萬美元或每股 1.81 美元，而 2021 年淨虧損為 630 萬美元或每股 2.36 美元。截至 2022 年 12 月 31 日的現金及現金等價物為 1,140 萬美元。 9 月 6 日，bioAffinity Technologies 透過 130 萬股單位的 IPO 籌集了約 600 萬美元的淨收益，每單位包括 1 股普通股、1 張可購買 1 股普通股的可交易認股權證和 1 張不可交易認股權證。

An additional $7.8 million was raised from the exercise of warrants and options. As a growth stage company, we intend to be opportunistic regarding potential financing activities, but we believe that funds available today provides sufficient capital to support planned operating activities through at least the next 12 months.

透過行使認股權證和選擇權又籌集了 780 萬美元。作為一家成長階段的公司，我們打算抓住機會進行潛在的融資活動，但我們相信，目前可用的資金足以支持至少未來 12 個月的計畫營運活動。

With that, I'll turn it back to Maria.

說完這些，我就把話題轉回瑪麗亞了。

Thank you, Michael. I look forward to a busy 2023 with many milestones for our shareholders to look forward to, including the launch of our CyPath Lung pivotal trial, the commercial expansion of our test and continued investments in R&D.

謝謝你，麥可。我期待著忙碌的 2023 年，我們的股東將迎來許多里程碑，包括啟動 CyPath Lung 關鍵試驗、我們測試的商業擴展以及對研發的持續投資。

With a strong balance sheet following our recent IPO and warrant exercise, along with key leadership appointments such as the expansion of our scientific and medical advisory board and R&D hires, bioAffinity Technologies is well positioned to execute on its milestones, advance our mission and deliver more valuable diagnostic utility.

憑藉近期首次公開發行 (IPO) 和認股權證行使後的強勁資產負債表，以及關鍵領導層的任命（例如擴大我們的科學和醫學顧問委員會以及招聘研發人員），bioAffinity Technologies 已準備好實現其里程碑、推進我們的使命並提供更有價值的診斷實用工具。

As a final comment, I'd like to let you know that this Wednesday, April 5, my colleagues and I will be ringing the NASDAQ closing bell to commemorate our recent IPO and listing on NASDAQ. I encourage all our listeners to tune in just before 4:00 p.m. Eastern on April 5 to celebrate this milestone with us.

最後，我想告訴大家，4 月 5 日星期三，我和我的同事將敲響納斯達克收盤鐘，以紀念我們最近在納斯達克的首次公開募股和上市。我鼓勵所有聽眾在下午 4:00 之前收聽。東部時間 4 月 5 日，與我們一起慶祝這一里程碑。

Thank you again for joining today's call. Operator, we're now ready to take questions.

再次感謝您參加今天的電話會議。接線員，我們現在可以回答問題了。

(Operator Instructions) Our first question will come from Steve Silver with Argus.

（操作員指示）我們的第一個問題來自 Argus 的 Steve Silver。

Congratulations on a very productive 2022 in some very challenging market conditions.

恭喜您在 2022 年極其艱難的市場條件下取得了豐碩成果。

Maria, you had mentioned in the prepared remarks that the company is gaining valuable insights into the initial launch of CyPath Lung. And I was just hoping to get a little bit more color in terms of any findings that the launch is providing, whether everything is going as you expected, maybe just looking for potential refinements. But if there's anything that the company really did not expect and that maybe the company is really adjusting more than you might have expected to the early launch?

瑪麗亞，您在準備好的發言中提到，公司正在對 CyPath Lung 的首次發布獲得寶貴的見解。我只是希望對此次發布會所提供的任何發現有更多的了解，無論一切是否都如預期的那樣進行，也許只是在尋找潛在的改進。但如果有什麼是公司真的沒有預料到的，也許公司對早期發布的調整確實比你預期的要多？

Well, first, thank you, and thanks for listening today.

嗯，首先，謝謝你，感謝你今天的收聽。

I think there is nothing new in the sense of something -- any surprise in how physicians have reacted and what we're hearing. But there are -- there is emphasis that we find very interesting as we move forward. And we are learning quite a bit. We do see that physicians like very much the ease of use of this test and the patients do as well.

我認為沒有什麼新的意義——醫生的反應和我們所聽到的內容沒有任何令人驚訝的地方。但隨著我們不斷前進，我們發現一些重點非常有趣。我們學到了很多。我們確實看到醫生非常喜歡這項測試的易用性，患者也是如此。

So you remember that this is a test that is where sputum, where the sample is collected at home. And we use a patient coach, someone who spends time over the phone largely with the patient to help them collect. This has resulted in very, very good sputum collection. In other words, our samples are coming in very well. And it's also something that physicians like because they have an initial discussion with the patients, they provide them with the test kit. The patient goes home, comes back with an answer.

所以你要記住，這是一個在家裡收集痰液樣本的測試。我們還聘請了一位耐心的教練，他大部分時間都透過電話與患者溝通，幫助他們收集資訊。這使得痰液收集效果非常非常好。換句話說，我們的樣品效果非常好。這也是醫生喜歡的事情，因為他們與患者進行了初步討論，並為他們提供了測試套件。病人回家後帶著答案回來了。

The other thing I think that the physicians have liked very much is the actionable results. In other words, they get a result that is helpful for them to know what to do in moving forward.

我認為醫生們非常喜歡的另一件事是可操作的結果。換句話說，他們得到的結果有助於他們知道接下來該做什麼。

So I think we're learning a lot more about the benefits of this test, and what moves the needle as far as the acceptance and the adoption of this test. And that -- all of that work goes into the work that we're doing with Havas and with Trinity and knowing and honing in on the brand and the messaging.

所以我認為我們對這項測試的好處以及如何推動這項測試的接受和採用有了更多的了解。而所有這些工作都融入到我們與 Havas 和 Trinity 的合作中，以及對品牌和訊息傳遞的了解和磨練中。

Congratulations again.

再次恭喜。

(Operator Instructions) Our next question comes from Aaron Thomson with -- a private investor.

(操作員指示)我們的下一個問題來自私人投資者 Aaron Thomson。

I was curious about the therapeutics that you're pursuing. I know you published some research and done some presentations regarding an siRNA. I was wondering if you could speak more, where you're going with that?

我對您正在研究的治療方法很好奇。我知道您發表了一些關於 siRNA 的研究並做了一些報告。我想知道您是否可以進一步談談您接下來的打算？

Yes, certainly. Thank you, and thank you for being an investor in bioAffinity.

是的，當然。謝謝你，也謝謝你成為 bioAffinity 的投資者。

So the company itself bioAffinity is very science and medically driven. In doing so or with that focus, the company started to -- we looked our research into the use of porphyrins, which is a marker for our test -- diagnostic test.

因此，bioAffinity 公司本身非常注重科學和醫學驅動。在這樣做或出於這個重點的情況下，公司開始——我們研究卟啉的使用，這是我們的測試——診斷測試的標記。

I give this as way of background. In our research with regards to porphyrin, we found that a certain knock down, a certain alteration to cells could affect a killing of cancer cells without any harm to normal cells. And that primarily is the focus of our research right now, which is continuing.

我以此作為背景。在我們對卟啉的研究中，我們發現，對細胞進行某種敲除或改變可以殺死癌細胞，而不會對正常細胞造成任何傷害。這是我們目前研究的重點，研究仍在繼續。

The siRNA that you mentioned is -- there's a number of siRNAs that we believe, and we have patent applications for can be used to knock down the self-surface markers and in doing so, kill cancer without harm to normal cells. It's very promising, but it's very early research, and I want to stress that.

您提到的 siRNA 是——我們相信有許多 siRNA 可以用來敲除自身表面標誌物，從而殺死癌細胞而不會損害正常細胞，我們已經申請了專利。這是非常有前景的，但這還處於非常早期的研究，我想強調這一點。

We are moving forward and intend to do animal studies with this, and we'll have more information as that work is done. But thank you for asking.

我們正在繼續進行並打算對此進行動物研究，隨著這項工作的完成，我們將獲得更多資訊。但謝謝你的詢問。

(Operator Instructions) It appears there are no further questions. This concludes our question-and-answer session. I would like to turn the conference -- pardon me. It looks like Aaron Thomson has a follow-up.

（操作員指示）似乎沒有其他問題了。我們的問答環節到此結束。我想把會議轉到——請原諒。看起來 Aaron Thomson 還有後續行動。

Okay. I'm sorry. I did have 1 more question about...

好的。對不起。我還有一個問題......

Sure. Please.

當然。請。

The expansion in Europe. I know that one of the documents you put out mentioned that you're working closely in the Netherlands to try to expand CyPath Lung. Wondering if you could provide more information on where that is in the stage?

在歐洲的擴張。我知道您發布的一份文件提到您正在與荷蘭密切合作，嘗試擴大 CyPath Lung。想知道您是否可以提供更多有關該階段進展的資訊？

Sure. So we chose the Netherlands as the initial stage of entry for a number of reasons. One is it's a country that has -- we've seen early adoption of new technologies. Our Chief Science and Medical Officer, Dr. Rebel received both her MD and her PhD in the Netherlands. She's Dutch from the Fre University in Amsterdam. So that also is obviously a benefit for us.

當然。因此，我們出於多種原因選擇荷蘭作為初始進入階段。一是，它是一個很早就開始採用新技術的國家。我們的首席科學和醫療官 Rebel 博士在荷蘭獲得了醫學博士學位和哲學博士學位。她是荷蘭人，畢業於阿姆斯特丹自由大學。所以這對我們來說顯然也是一個好處。

The CE marking of new tests has become more difficult than prior years with new regulations. And so we are stepping through the requirements in order to first CE mark the test in the EU. And our entry into the Netherlands, we think, is a good first step.

由於新的規定，新測試的 CE 標誌比前幾年更加困難。因此，我們正在逐步滿足要求，以便在歐盟首次獲得 CE 標誌測試。我們認為，進入荷蘭是一個好的開始。

This is not something that will be done this year. I look to next year as far as the CE marking process, but we have begun to do that. We have strong patent portfolio in the EU, 1 that we see growing and strengthening over the next couple of years. So it becomes a very important market.

這不是今年就能完成的事。我期待明年能夠完成 CE 標誌流程，但我們已經開始這麼做了。我們在歐盟擁有強大的專利組合，我們預計未來幾年這一組合將會持續成長和加強。因此它成為一個非常重要的市場。

The EU also most of the EU, I should say, does not have the requirements for early screening or recommendations, I should say, for early screening as the U.S. does. So it is possible that our test is used more earlier in the process of diagnosis as a first screen for lung cancer.

我應該說，歐盟大部分地區也沒有像美國那樣對早期篩檢提出要求或建議。因此，我們的測試有可能在診斷過程中更早地用作肺癌的首次篩檢。

This is because 2 -- CyPath Lung has shown very balanced accuracy, meaning that it has high sensitivity in the ability to find cancer and it has high specificity in the ability to tell a patient that they do not have cancer. So it has the potential to be a very good screening test and the EU may be the first entry into that pathway.

這是因為 2——CyPath Lung 表現出了非常均衡的準確性，這意味著它在發現癌症的能力上具有很高的敏感性，並且在告訴患者他們沒有患癌症的能力上具有很高的特異性。因此，它有可能成為一個非常好的篩選測試，而歐盟可能是第一個進入該途徑的國家。

As it appears there are no further questions, this concludes the question-and-answer session. I would like to turn the conference back over to management for any closing remarks.

看來沒有其他問題了，問答環節到此結束。我想將會議交還給管理階層，以便他們發表結束語。

Thank you. I want to thank everyone for being part of our first call as a public company. We have many, many milestones that we look to complete this year, and we hope to share with you. Thank you.

謝謝。我要感謝大家參加我們作為上市公司的首次電話會議。我們今年有很多里程碑要完成，我們希望與你們分享。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。