Intelligent Bio Solutions Inc (INBS) 2021 Q4 法說會逐字稿

Greetings, and welcome to the GBS Inc.

您好，歡迎來到 GBS Inc.

Fourth Quarter 2021 Earnings Conference Call.

2021 年第四季財報電話會議。

(Operator Instructions) As a reminder, this conference is being recorded.

（操作員指示）謹此提醒，本次會議正在錄製中。

It is now my pleasure to introduce your host, Alex Arzeno, Investor Relations for GBS.

現在我很高興向您介紹主持人，GBS 投資者關係部門的 Alex Arzeno。

Thank you.

謝謝。

You may begin.

你可以開始了。

Thank you, and good afternoon.

謝謝你，下午好。

Joining us today from the company are Harry Simeonidis, President and CEO; and Spiro Sakiris, Chief Financial Officer.

今天加入我們公司的是總裁兼執行長 Harry Simeonidis；和首席財務官 Spiro Sakiris。

A press release announcing the results and the update was issued this afternoon and is available now on the GBS website.

今天下午發布了一份宣布結果和更新的新聞稿，現已在 GBS 網站上發布。

I will now read the company's safe harbor statement.

我現在將閱讀該公司的安全港聲明。

Some of the statements on this conference call are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act of 1995, which involves risks and uncertainties.

本次電話會議的部分陳述屬於《1933 年證券法》第27A 條、《1934 年證券交易法》第21E 條和《1995 年私人證券訴訟改革法》含義內的前瞻性陳述，涉及風險和不確定性。

Forward-looking statements on this call include, without limitation, GBS Inc.'s ability to develop and commercialize its diagnostic tests, realize commercial benefit from its partnerships and collaborations and secure regulatory approvals, among others.

本次電話會議的前瞻性陳述包括但不限於 GBS Inc. 開發診斷測試並將其商業化的能力、從合作夥伴關係和協作中實現商業利益以及獲得監管部門批准等的能力。

Although GBS believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements.

儘管 GBS 認為此類前瞻性陳述中反映的預期截至做出之日是合理的，但預期可能與此類前瞻性陳述中明示或暗示的結果有重大差異。

GBS has attempted to identify forward-looking statements by terminology, including believes, estimates, anticipates, expects, plans, projects, intends, potential, may, could, might, will, should, approximately or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements.

GBS 試圖透過術語來識別前瞻性陳述，包括相信、估計、預期、預期、計劃、項目、打算、潛力、可能、可能、可能、將、應該、大約或其他傳達未來事件或不確定性的詞語。結果來辨識這些前瞻性陳述。

These statements are only predictions that involve known and unknown risks, uncertainties and other factors, including the company's public filings filed with the Securities and Exchange Commission.

這些陳述僅是涉及已知和未知風險、不確定性和其他因素的預測，包括該公司向美國證券交易委員會提交的公開文件。

Any forward-looking statements contained in the press release speak only as of its date.

新聞稿中包含的任何前瞻性陳述僅代表截至發布之日的情況。

We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

我們沒有義務更新本新聞稿中包含的任何前瞻性聲明，以反映發布日期之後發生的事件或情況，或反映意外事件的發生。

During this conference call, the company may refer to EBITDA, a non-GAAP measure.

在本次電話會議期間，本公司可能會參考 EBITDA（非公認會計準則衡量標準）。

EBITDA is not and should not be considered an alternative to net income loss, income loss from operations or any other measure for determining operating performance.

EBITDA 並非也不應被視為淨收入損失、營運收入損失或任何其他確定營運績效指標的替代方案。

EBITDA is normally calculated by adding back income tax, depreciation, amortization to net income loss.

EBITDA 通常是透過將所得稅、折舊、攤提加回淨收入損失來計算的。

I would like to now turn the floor over to Harry, President and CEO of GBS.

我現在請 GBS 總裁兼執行長 Harry 發言。

Harry, please go ahead.

哈利，請繼續。

Thank you, Alex.

謝謝你，亞歷克斯。

Good afternoon, and thank you for joining us on our quarterly business and financial update call today.

下午好，感謝您今天參加我們的季度業務和財務更新電話會議。

We issued our fourth quarter and full year 2021 financial and operating results after the close of market today.

今天收盤後，我們發布了 2021 年第四季和全年財務和營運業績。

And I hope you've been able to review them.

我希望您能夠審閱它們。

GBS is focused on developing and commercializing innovative biosensor for point-of-care monitoring and diagnostic tests.

GBS 專注於開發和商業化用於即時監測和診斷測試的創新生物感測器。

We leverage proprietary technologies, which allows saliva-based testing approaches to be as accurate as other [draw-based] methods such as serum, blood or urine.

我們利用專有技術，使基於唾液的檢測方法與其他[基於抽取的]方法（例如血清、血液或尿液）一樣準確。

We believe offering patients a convenient, low-cost and disposable test strip as small as a piece of gum will allow compliance and frequency of testing to reach new levels in developed economies.

我們相信，為患者提供像一塊口香糖那麼小的方便、低成本的一次性測試條，將使已開發經濟體的合規性和測試頻率達到新的水平。

GBS' goal is to have our technology be readily available to both patients and physicians at an affordable price that will be comparable to what is on the market today.

GBS 的目標是讓患者和醫生都能以可承受的價格輕鬆獲得我們的技術，這與當今市場上的技術相當。

We have identified 130 additional diagnostic tests.

我們已經確定了 130 項額外的診斷測試。

In due time, we anticipate our technology will have broad applications across different diagnostic modalities, enabling diagnostic tests such as clinical chemistry, immunology, tumor markers, allergens and endocrinology.

在適當的時候，我們預期我們的技術將在不同的診斷方式中廣泛的應用，從而實現臨床化學、免疫學、腫瘤標記、過敏原和內分泌學等診斷測試。

The biosensor technology was developed at the University of Newcastle Australia and was acquired by Life Sciences Biosensor Diagnostic Pty Ltd.

此生物感測器技術由澳洲紐卡斯爾大學開發，並被 Life Sciences Biosensor Diagnostic Pty Ltd 收購。

The technology was then licensed to GBS for the Asia Pacific region and has been under continuous development with GBS over the last 7 years.

該技術隨後被授權給 GBS 在亞太地區使用，並在過去 7 年中與 GBS 一起不斷開發。

The biosensor is a platform technology, which uses proprietary organic thin film transistor technology, which is patent protected until the year 2033.

該生物感測器是一種平台技術，採用專有的有機薄膜電晶體技術，該技術的專利保護期截至2033年。

Currently, we are advancing 2 lead product candidates towards commercialization.

目前，我們正在推進 2 個主要候選產品的商業化。

First, our flagship product candidate is a novel saliva glucose biosensor, a convenient point-of-care test expected to substitute the invasive finger pricking, blood glucose monitoring for patients living with diabetes.

首先，我們的旗艦候選產品是一種新型唾液葡萄糖生物感測器，這是一種方便的現場護理測試，有望取代侵入性手指刺穿、糖尿病患者的血糖監測。

And second, our saliva SARS-CoV-2 antibody test candidate, which will provide real-time quantitative detection for SARS-CoV-2 virus antibodies.

其次，我們的唾液 SARS-CoV-2 抗體測試候選產品，將為 SARS-CoV-2 病毒抗體提供即時定量檢測。

With respect to our glucose biosensor technology for patients living with diabetes, we believe our tests will have the ability to make blood-based finger prick testing obsolete.

關於我們為糖尿病患者提供的葡萄糖生物感測器技術，我們相信我們的測試將能夠取代基於血液的指尖採血測試。

When you look at patients' preference, as we have done extensively throughout our patient survey, our saliva-based glucose biosensor that is pain-free, noninvasive, simple to use and convenient is the preferred method when compared to the current blood testing mechanism available today.

當您考慮患者的偏好時，正如我們在整個患者調查中所做的廣泛工作一樣，與目前可用的血液檢測機制相比，我們基於唾液的葡萄糖生物感測器無痛、非侵入性、使用簡單且方便，是首選方法今天。

Unfortunately, there have been little-to-no recent advancement around testing for people living with diabetes.

不幸的是，最近在糖尿病患者檢測方面幾乎沒有任何進展。

And this is where we see the very attractive opportunity.

這就是我們看到非常有吸引力的機會的地方。

Diabetes is a global epidemic, and the disease is growing rapidly with markets estimated to exceed 465 million people and we expect to grow to 700 million by the year 2045.

糖尿病是一種全球流行病，該疾病正在迅速增長，市場人口估計超過 4.65 億，我們預計到 2045 年將增長到 7 億。

Our commercial license applies to the world's largest diabetes population, the Asia Pacific region.

我們的商業許可適用於全球糖尿病人口最多的亞太地區。

This is a market that GBS will be addressing to bring an affordable, noninvasive real-time point-of-care diagnostic tests to people living with diabetes.

GBS 將瞄準這個​​市場，為糖尿病患者提供負擔得起的、非侵入性的即時護理點診斷測試。

Rapidly rising rates of diabetes have been seen in the APAC region.

亞太地區的糖尿病發生率迅速上升。

And according to the latest data, more than 170 million people living with diabetes, representing over 36% of the world's total population of people living with diabetes.

而根據最新數據，超過1.7億人患有糖尿病，佔全球糖尿病總人口的36%以上。

Given what we believe of the superior analytical characteristics of the biosensor technology and the current development stage, it was important that GBS, with its global license agreement, joined the international effort to combat the COVID-19 pandemic with its first-class technology.

鑑於我們相信生物感測器技術的卓越分析特性和當前的發展階段，GBS 憑藉其全球授權協議，以其一流的技術加入國際社會對抗 COVID-19 大流行的努力，這一點非常重要。

In 2020, as the emergence of COVID-19 infections began to skyrocket exponentially, GBS decided to expedite a collaboration with the Wyss Institute of Biologically Inspired Engineering at Harvard University in order to develop a more accurate and real-time SARS COVID antibody testing to support both the international law vaccination efforts and testing.

2020 年，隨著 COVID-19 感染的出現開始呈指數級飆升，GBS 決定加快與哈佛大學 Wyss 生物啟發工程研究所的合作，以開發更準確和實時的 SARS COVID 抗體檢測，以支持國際法疫苗接種工作和檢測。

This past quarter, and indeed the year, has been one of both challenges and opportunities as COVID-19 has become a focal point across the global health care industry and a good part of our daily loads.

過去的一個季度，甚至這一年，既是挑戰也是機遇，因為 COVID-19 已成為全球醫療保健行業的焦點，也是我們日常工作的重要組成部分。

Today, as we learn more about the delta variant, we must all recognize that COVID-19 is not going to be eradicated as easily, and we must remain vigilant.

今天，隨著我們對 Delta 變種有了更多了解，我們都必須認識到，COVID-19 不會輕易被根除，我們必須保持警惕。

Recent reports from the World Health Organization and CDC indicate this new strain is more contagious and can allow people already vaccinated to transmit the virus.

世界衛生組織和疾病預防控制中心最近的報告表明，這種新病毒株傳染性更強，可以讓已經接種疫苗的人傳播病毒。

While these developments are unfortunate on so many levels, it is important that we, as a society, now understand the importance of COVID testing and how we can implement these tools in our lives so we can better prepare for any future pandemics that arise.

雖然這些發展在許多層面上都是不幸的，但重要的是，作為一個社會，我們現在必須了解新冠病毒檢測的重要性，以及我們如何在生活中使用這些工具，以便我們能夠更好地為未來出現的任何流行病做好準備。

At GBS, we are proud to be joining the efforts to enhance health care diagnostics by providing convenient and accurate antibody testing as a long-term efficacy of approved vaccinations have yet to be demonstrated clinically.

在 GBS，我們很自豪能夠透過提供方便、準確的抗體檢測來加入加強醫療保健診斷的努力，因為批准的疫苗的長期功效尚未得到臨床證明。

Turning to GBS' fourth quarter and full year financial results, which our CFO, Spiro Sakiris, will discuss in greater detail shortly, represented another solid period for our NASDAQ-listed companies, creating awareness across the medical and investment communities.

談到GBS 第四季度和全年的財務業績，我們的財務長Spiro Sakiris 很快就會詳細討論這一業績，這代表了我們在納斯達克上市的公司的又一個穩健時期，提高了整個醫療和投資界的認識。

Briefly, I'd just like to highlight a couple of financial points to start.

簡而言之，我想先強調幾個財務要點。

In December 2020, we went public by an initial public offering and raised $21.6 million in gross proceedings and listed on the NASDAQ Global Stock Market.

2020 年 12 月，我們透過首次公開募股上市，募集資金總額 2,160 萬美元，並在納斯達克全球股票市場上市。

Proceeds from this [formality] were to be utilized to obtain regulatory approvals, pipeline advancements, marketing and establishing a distribution network in addition to working capital.

除營運資金外，此[手續]所得收益還將用於獲得監管部門批准、管道進度、行銷和建立分銷網絡。

And most recently, GBS was awarded a grant of $4.7 million from the Australian federal government to fund the build out of our high-tech biosensor manufacturing facility.

最近，GBS 獲得了澳洲聯邦政府 470 萬美元的撥款，用於資助建造我們的高科技生物感測器製造設施。

This recognition goes beyond just the value of the brand, as biosensor platform technology was identified by the Australian government as 1 of only 6 national manufacturing priorities under its modern manufacturing strategy.

這種認可不僅僅是品牌的價值，因為生物感測器平台技術被澳洲政府確定為其現代製造策略下僅有的 6 個國家製造優先事項之一。

The facility will be solely focused on advancing GBS' products.

該工廠將專注於推進 GBS 的產品。

We continue to be physically responsible and have multiple tools and strategies to extend our cash runway through sublicensing and collaborations, which have been provided as a diverse set of financial opportunities to the company.

我們繼續承擔實際責任，並擁有多種工具和策略，透過再授權和合作來擴展我們的現金跑道，這些工具和策略為公司提供了一系列多樣化的財務機會。

Now let's review some of our recent key highlights.

現在讓我們回顧一下我們最近的一些重要亮點。

Our core focus remains on the product development on both our saliva glucose and saliva SARS-CoV-2 antibody tests.

我們的核心重點仍然是唾液葡萄糖和唾液 SARS-CoV-2 抗體測試的產品開發。

In February this year, we announced the execution of a sponsored research agreement with Johns Hopkins Bloomberg School of Public Health to accelerate the development of the saliva collection protocols for the saliva-based diagnostic test.

今年 2 月，我們宣布與約翰霍普金斯大學彭博公共衛生學院簽署一項贊助研究協議，以加速基於唾液的診斷測試的唾液採集方案的發展。

This collaboration pulls together resources from Johns Hopkins Environmental Health and Engineering as well as its School of Public Health and the lab saliva of biomarkers and inflexible disease programs.

這項合作匯集了約翰霍普金斯大學環境健康與工程及其公共衛生學院的資源以及生物標記和頑固疾病計畫的實驗室唾液。

In February, GBS also announced its collaboration with the Wyss Institute of Biologically Inspired Engineering at Harvard University to develop a COVID-19 antibody test.

今年 2 月，GBS 也宣布與哈佛大學 Wyss 生物啟發工程研究所合作開發 COVID-19 抗體測試。

Subsequently to integrate the Wyss Institute rapid E (sic) [eRapid] technology with GBS' proprietary transistor sensor technology.

隨後將 Wyss Institute Rapid E（原文如此）[eRapid] 技術與 GBS 專有的電晶體感測器技術整合。

Later in the spring, we received approval from Harvard Longwood Campus institute review Board to commence the validation study to test clinical samples from the COVID-19 repository.

今年春季晚些時候，我們獲得了哈佛大學朗伍德校區研究所審查委員會的批准，開始驗證研究以測試來自 COVID-19 儲存庫的臨床樣本。

In order to advance these assets into commercialization phase as effectively as possible, management has preemptively executed certain priorities to ready the company post an approval.

為了盡可能有效地將這些資產推進商業化階段，管理層預先執行了某些優先事項，為公司獲得批准做好準備。

In June, GBS completed a global voice of customer survey of people living with diabetes to verify the desirability, discuss the applications in the daily life and review the product features of its saliva glucose biosensor.

6月，GBS完成了針對糖尿病患者的全球客戶心聲調查，以驗證唾液葡萄糖生物感測器的需求、討論其在日常生活中的應用並審查其產品特性。

Key findings were, in all markets: 9 out of 10 patients responded positively to our biosensor platform; 7 out of 10 patients were seriously interested in purchasing the product when it is released; and 3 out of 10 wanted to be placed on a preorder waiting list ahead of the product release; finally, while patients in the U.S. indicated the price of a pain-free alternative to current glucose monitoring will play a role in determining their decision to purchase a new device, patients in China indicated price was not an issue as long as the product was accurate and reliable.

在所有市場中，主要發現是：十分之九的患者對我們的生物感測器平台做出積極反應；當產品發佈時，十分之七的患者對購買該產品非常感興趣；十分之三的人希望在產品發布之前被列入預訂等待名單；最後，雖然美國患者表示當前血糖監測的無痛替代品的價格將在決定他們購買新設備時發揮作用，但中國患者表示只要產品準確，價格就不是問題且可靠。

Most recently, we engaged with L.E.K Consulting to deliver a short list of suitable commercial partners for distribution in China as we prepare for the initial discussion with potential collaborators in this region.

最近，我們與 L.E.K Consulting 合作，提供了一份適合在中國分銷的商業合作夥伴的簡短名單，同時我們準備與該地區的潛在合作者進行初步討論。

On behalf of GBS' senior management team, I want to express our gratitude to all our employees for their perseverance and dedication to the company in these challenging times.

我謹代表 GBS 的高階管理團隊向所有員工表示感謝，感謝他們在這個充滿挑戰的時期對公司的堅持和奉獻。

Our continued grit and perseverance can bring a shift to the point-of-care diagnostic industry as affordable saliva-based testing will 1 day deliver a more accurate and convenient way to conduct accurate testing.

我們持續的勇氣和毅力可以為現場診斷行業帶來轉變，因為經濟實惠的基於唾液的測試將有一天提供一種更準確、更方便的方式來進行準確的測試。

GBS' goal is to align our tests to our patients' needs by providing an affordable noninvasive test at point of care in an easy and administrative test strip.

GBS 的目標是透過簡單且易於管理的測試條在護理點提供經濟實惠的非侵入性測試，使我們的測試滿足患者的需求。

We can empower patients to test easily and safely for multiple indications.

我們可以幫助患者輕鬆、安全地測試多種適應症。

We have made important advancements across the organization in 2021, and we are confident in both our development and commercial approach as well as our ability to execute on each year ahead.

2021 年，我們在整個組織中取得了重要進展，我們對我們的開發和商業方法以及未來每一年的執行能力充滿信心。

With these insights, I would like to now turn and call over our CFO, Spiro Sakiris, for a more detailed review of the 2021 financials.

有了這些見解，我現在想請我們的財務長 Spiro Sakiris 來對 2021 年的財務狀況進行更詳細的審查。

Spiro?

斯皮羅？

Thanks, Harry.

謝謝，哈利。

As Harry mentioned, 2021 was an impressive period of advancement and development of GBS' biosensor-based point-of-care test, but also for GBS as a growing organization.

正如 Harry 所提到的，2021 年是 GBS 基於生物感測器的現場護理測試取得令人印象深刻的進步和發展的時期，對於 GBS 作為一個不斷發展的組織來說也是如此。

For the year ended June 30, 2021, the company has had a preliminary net loss of $8.5 million or $0.68 per share compared to net loss of $3.3 million or $0.37 per share for the same period last year.

截至2021年6月30日的年度，該公司初步淨虧損為850萬美元，即每股0.68美元，而去年同期的淨虧損為330萬美元，即每股0.37美元。

This is predominantly due to the acceleration and the development of our commercialization expenditure.

這主要是由於我們商業化支出的加速和發展。

In December 2020, the company closed its IPO and generated approximately $19.7 million in net cash proceeds.

2020 年 12 月，該公司完成了 IPO，產生了約 1,970 萬美元的淨現金收益。

Government support income was $578,000 for the 3 months ended June 30, 2021, and 0 for the same period in 2020, respectively.

截至2021年6月30日止3個月的政府支持收入為578,000美元，2020年同期為0。

The company set on a path from the IPO to utilize the key resources and commercial partners to advance the projects towards commercializing.

公司從IPO開始，就走上了利用關鍵資源和商業夥伴推動專案商業化的道路。

To achieve this, acceleration of expenditures is required with the major categories being development and commercialization for the financial year of $3.8 million compared to the year prior of $0.6 million, and employee benefits expense of $1.7 million compared to the year prior of $1.1 million.

為了實現這一目標，需要加快支出，主要類別是本財政年度的開發和商業化支出為380 萬美元，而上年為60 萬美元，員工福利支出為170 萬美元，而上年為110 萬美元。

As of June 30, 2021, the company's cash, cash equivalents and marketable securities totaled approximately $12.7 million compared to approximately $430,000 on June 30, 2020.

截至2021年6月30日，該公司的現金、現金等價物及有價證券總額約為1,270萬美元，而2020年6月30日約為43萬美元。

As of June 30, 2021, the company had 12.4 million shares outstanding.

截至2021年6月30日，該公司已發行股票1,240萬股。

Management continues to be fiscally responsible and has multiple terms and strategies to extend its runway through sublicense agreements and collaborations, which will provide a diverse set of funding options to the company.

管理層繼續承擔財務責任，並製定多項條款和策略，透過再許可協議和合作來擴展其跑道，這將為公司提供多種融資選擇。

GBS is of the view that the current operating plan and financial resources, its cash, cash equivalents and marketable securities as of June 30, 2021, will be sufficient to cover expenses and capital requirements into the fourth calendar quarter of 2022.

GBS認為，截至2021年6月30日的當前營運計畫和財務資源、現金、現金等價物和有價證券將足以滿足2022年第四季的費用和資本要求。

I'll now turn it back to Harry for the closing remarks.

現在我將把它轉回給哈利作結束語。

Thank you, Spiro.

謝謝你，斯皮羅。

As Spiro made it clear, we are very proud of our accomplishments we have made this year.

正如 Spiro 明確表示的那樣，我們對今年的成就感到非常自豪。

Heading into fiscal year 2022, we anticipate benefiting from, among others: developing SARS-CoV-2 antibody biosensor for FDA EUA submission; completing clinical protocols for FDA review for saliva glucose biosensor; establishing the world's first validated traceable saliva glucose reference method in collaboration with Johns Hopkins; progressing design transfer to manufacturing for our saliva glucose biosensor; securing out-licensing and sublicensing partnership opportunities for commercialization in the APAC region; and finally, completing our build of a high-tech biosensor facility.

進入 2022 財年，我們預計將受益於：開發 SARS-CoV-2 抗體生物感測器以提交 FDA EUA；完成唾液葡萄糖生物感測器 FDA 審查的臨床方案；與約翰霍普金斯大學合作建立世界上第一個經過驗證的可追溯唾液葡萄糖參考方法；我們的唾液葡萄糖生物感測器正在進行設計轉移到製造；確保亞太地區商業化的對外許可和再許可合作機會；最後，完成我們高科技生物感測器設施的建造。

We, as management, and the Board are working in a lockstep to channel GBS' robust capabilities to benefit all its shareholders and ultimately enhance shareholder value.

作為管理層和董事會，我們正在齊心協力，利用 GBS 的強大能力造福所有股東，並最終提高股東價值。

We will now open the call for questions.

我們現在開始提問。

Operator, please open the floor to questions.

接線員，請開始提問。

(Operator Instructions) Our first question comes from Brian (sic) [John] Vandermosten with Zacks SCR.

（操作員說明）我們的第一個問題來自 Zacks SCR 的 Brian（原文如此）[John] Vandermosten。

This is John Vandermosten.

這是約翰范德莫斯坦。

First question is on the L.E.K.

第一個問題是關於 L.E.K.

Consulting.

諮詢。

Hopefully, that's coming along great.

希望一切進展順利。

What are some of the characteristics you're looking for in the partners for distribution in the APAC region?

您在亞太地區的經銷合作夥伴中尋找哪些特徵？

John, thank you for your question.

約翰，謝謝你的提問。

I really appreciate that, and thanks for joining as well.

我真的很感激，也感謝您的加入。

John, the characteristics in terms of any of our distributors going into our market is ensuring that they, first of all, have the capability to reach as many patients as possible.

約翰，進入我們市場的任何經銷商的特點是確保他們首先有能力接觸盡可能多的患者。

So they do require a prior footprint within the market.

因此，他們確實需要事先在市場上佔有一席之地。

The other key aspect that they do require and the capabilities that we are looking for in our partners is the ability to be very well connected, both with the health care industry, but also from a regulatory standpoint as it is very important when we bring this product to market that we enter the market very fast.

他們確實需要的另一個關鍵方面以及我們在合作夥伴中尋找的能力是與醫療保健行業以及從監管角度來看非常重要的能力，因為當我們將其引入時，這一點非常重要產品推向市場，我們進入市場的速度非常快。

So those are the key aspects.

這些是關鍵方面。

Obviously, a lot more characteristics that we're looking for the ideal partner.

顯然，我們正在尋找理想合作夥伴的更多特徵。

But in summary, one, they've got an existing footprint so we can get into the market very fast; and secondary is having strong relationships, both with health care and with regulatory bodies.

但總而言之，第一，他們已經擁有了現有的足跡，因此我們可以非常快速地進入市場；其次是與醫療保健和監管機構建立牢固的關係。

Okay.

好的。

Great.

偉大的。

Great, that makes sense.

太好了，很有道理。

And one of the goals you outlined for, I think, in a previous quarterly update was achieving the clinical protocol and I think you guys have achieved that now.

我認為，您在先前的季度更新中概述的目標之一是實現臨床方案，我認為您現在已經實現了。

Were you able to touch base with the EMA and the FDA to help develop that?

您是否能夠與 EMA 和 FDA 取得聯繫來幫助開發此專案？

Or is that something still that you're going to refine going forward?

或者說，這仍然是您今後要完善的東西嗎？

And how does it look in terms of talking to the agencies to get their input before you finalize them?

在最終確定之前與各機構交談以獲取他們的意見，情況如何？

Yes.

是的。

John, again, great question.

約翰，又是一個好問題。

Look, it's always important to ensure that when we do talk to the authorities, we've got all our ducks in the line as well.

看，確保當我們與當局對話時，我們也做好了準備，這一點始終很重要。

On that aspect, we continuously do talk to the FDA ensuring that we have got the right process and methodology as we move forward.

在這方面，我們不斷與 FDA 溝通，確保我們在前進過程中擁有正確的流程和方法。

We are in the process right now of doing our presubmission with the FDA, so we can actually ensure that all our protocols are in place.

我們現在正在向 FDA 進行預先提交，因此我們實際上可以確保我們的所有協議都已到位。

And this is expected to continue over the next quarter or so.

預計這種情況將在下個季度左右持續下去。

So as you explained, yes, absolutely.

正如您所解釋的，是的，絕對如此。

We are advancing our clinical protocols.

我們正在推進我們的臨床方案。

And when we are ready to finalize those, we'll be doing a submission to the FDA, which we expect, hopefully, this side of this year.

當我們準備好最終確定這些內容時，我們將向 FDA 提交文件，我們希望在今年下半年提交。

Okay.

好的。

Great.

偉大的。

Great.

偉大的。

And last one for me is, is there a time line on the construction of that manufacturing facility?

最後一個問題是，該製造工廠的建設有時間表嗎？

Is that something we expect in the, I guess, in the next month or next quarters?

我想，這是我們期望在下個月或下個季度發生的事情嗎？

Or what should we think about in terms of time line for having that online?

或者我們應該在上線時間方面考慮什麼？

Yes.

是的。

John, look, we have commenced straight away as soon as we've got the grant, which we were 1 of only 6 companies in Australia that was given this grant, and we were very excited about this.

約翰，你看，我們一收到撥款就立即開始工作，我們是澳洲僅有的 6 家獲得這筆撥款的公司之一，我們對此感到非常興奮。

We started straight away.

我們立即開始。

So we've actually shortlisted a number of sites as we're speaking now.

因此，正如我們現在所說的那樣，我們實際上已經將一些網站列入了候選名單。

And that will be accelerated in terms of once we get in there and then start ordering the equipment and doing the manufacturing fit out.

一旦我們進入那裡，然後開始訂購設備並進行製造裝配，這將會加速。

We expect that one to be -- we expect to have a site identified and into an agreement by the end of this quarter.

我們預計到本季末將確定一個地點並達成協議。

And then the completion of the build, depending on the time line, outsourcing the manufacturing and the equipment that we need for the facility because this is a very high-tech facility.

然後根據時間線完成建設，外包我們設施所需的製造和設備，因為這是一個非常高科技的設施。

Thank you, John.

謝謝你，約翰。

Always a pleasure.

總是一種樂趣。

At this time, there are no further questions.

目前，沒有其他問題了。

I'd like to turn the floor back over to Mr. Simeonidis for closing remarks.

我想請西蒙尼迪斯先生做總結發言。

Thank you, operator.

謝謝你，接線生。

Thank you, everyone, very much for joining our call today.

非常感謝大家今天加入我們的電話會議。

Look, we remain very excited for the future of GBS and its multiple product opportunities in both the near and long term.

看，我們對 GBS 的未來及其近期和長期的多種產品機會仍然感到非常興奮。

Our biosensor technology has fueled our passion to develop affordable, noninvasive, real-time point-of-care diagnostic test for both patients and their primary health care providers.

我們的生物感測器技術激發了我們對患者及其初級衛生保健提供者開發負擔得起的、非侵入性的、即時的護理點診斷測試的熱情。

We appreciate everyone's support, and thank you again for joining our annual conference update call.

我們感謝大家的支持，並再次感謝您參加我們的年度會議更新電話會議。

Thank you for your participation.

感謝您的參與。

You may disconnect your lines at this time, and have a great rest of the day.

此時您可以斷開線路，好好休息一下。