Aixcrypto Holdings Inc (AIXC) 2021 Q1 法說會逐字稿

Good day. And welcome to the Qualigen Therapeutics business update conference. (Operator Instructions) Please note, this event is being recorded.

再會。歡迎參加 Qualigen Therapeutics 業務更新會議。 （操作員說明）請注意，正在記錄此事件。

I would now like to turn the conference over to Yvonne Briggs. Please go ahead.

我現在想把會議交給伊馮·布里格斯。請繼續。

Thank you, operator. And good afternoon. This is Yvonne Briggs with LHA. Thank you all for joining Qualigen Therapeutics' business update conference call. Before we begin, I'd like to remind listeners that comments made during this call by management will include forward-looking statements within the meaning of federal securities laws.

謝謝你，接線員。下午好。我是 LHA 的伊馮·布里格斯 (Yvonne Briggs)。感謝大家參加 Qualigen Therapeutics 的業務更新電話會議。在我們開始之前，我想提醒聽眾，管理層在本次電話會議中發表的評論將包括聯邦證券法含義內的前瞻性陳述。

These forward-looking statements involve risks and uncertainties that could cause actual results to be materially different from any anticipated results. For a list and description of risks and uncertainties, please review Qualigen's filings with the SEC.

這些前瞻性陳述涉及風險和不確定性，可能導致實際結果與任何預期結果存在重大差異。有關風險和不確定性的列表和描述，請查看 Qualigen 向 SEC 提交的文件。

Importantly, this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast today, August 18, 2020. Except as required by law, Qualigen undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this call.

重要的是，本次電話會議包含的時間敏感信息僅截至今天（2020 年8 月18 日）直播之日準確。除法律要求外，Qualigen 不承擔修改或更新任何前瞻性陳述以反映未來情況的義務。本次電話會議之後發生的事件或情況。

Joining me today from Qualigen are Michael Poirier, President and CEO and Chairman; and Chris Lotz, the company's Chief Financial Officer. During today's call, management will provide an overview of the company's development programs and future milestones and its recent financial results. At the conclusion of the prepared remarks, we'll open the call to questions.

今天與我一起來自 Qualigen 的還有總裁兼首席執行官兼董事長 Michael Poirier；以及公司首席財務官克里斯·洛茨(Chris Lotz)。在今天的電話會議中，管理層將概述公司的發展計劃、未來的里程碑以及最近的財務業績。在準備好的發言結束後，我們將開始提問。

With that, let me turn the call over to Michael Poirier. Michael?

現在，讓我把電話轉給邁克爾·普瓦里爾。邁克爾？

Good afternoon, everyone. And thank you for joining the call today. Since completing our reverse merger almost three months ago, it's been an exciting and productive time for the company. We expanded our therapeutics pipeline by signing two more exclusive licensing agreements with the University of Louisville for cancer and antiviral drug candidates, developed and then initiated shipments of our COVID-19 antibody test on our FastPack PRO System, and raised an additional $18 million of capital. All of which we will review shortly.

大家下午好。感謝您今天加入電話會議。自從大約三個月前完成反向併購以來，這對公司來說是一個令人興奮且富有成效的時期。我們與路易斯維爾大學簽署了另外兩項針對癌症和抗病毒候選藥物的獨家許可協議，擴大了我們的治療產品線，在我們的FastPack PRO 系統上開發並啟動了我們的COVID-19 抗體測試的發貨，並籌集了額外的1800 萬美元資本。我們將很快審查所有這些內容。

As this is our first conference call as a public company and my first as a public company CEO, let me begin by welcoming our new shareholders and providing some background on Qualigen Therapeutics.

由於這是我們作為上市公司的第一次電話會議，也是我作為上市公司首席執行官的第一次電話會議，因此，首先讓我對我們的新股東表示歡迎，並介紹一些有關Qualigen Therapeutics 的背景知識。

I founded Qualigen over 20 years ago with the first commercialized product being the FastPack rapid diagnostic system. FastPack provides rapid and accurate point-of-care testing with an assay menu of nine tests, including tests for prostate cancer, thyroid function, metabolic disorders, and research applications for physician offices, clinics, and small hospitals worldwide.

20 多年前，我創立了 Qualigen，第一個商業化產品是 FastPack 快速診斷系統。 FastPack 提供快速、準確的現場護理測試，具有九種測試的分析菜單，包括前列腺癌、甲狀腺功能、代謝紊亂的測試以及針對全球醫生辦公室、診所和小型醫院的研究應用。

Since launch, we have sold more than $100 million worth of FastPack systems and test pouches. We see these historic sales to be a good indicator that the Qualigen knows how to develop and manufacture medical products, how to get them approved through the FDA, and how to bring them to market worldwide.

自推出以來，我們已售出價值超過 1 億美元的 FastPack 系統和測試袋。我們認為這些歷史性的銷售是一個很好的指標，表明 Qualigen 知道如何開發和製造醫療產品、如何獲得 FDA 批准以及如何將其推向全球市場。

Diagnostics is a highly competitive market with a challenging reimbursement environment. As a result, a few years ago, we accelerated our focus on therapeutics, which included our decision [of] recent completion of our go-public strategy. I am pleased to say we now have a robust pipeline of product candidates, drug candidates that we look forward to advancing through clinical development and a materially stronger balance sheet to see this through.

診斷是一個競爭激烈的市場，報銷環境充滿挑戰。因此，幾年前，我們加快了對治療藥物的關注，其中包括我們最近完成的上市戰略的決定。我很高興地說，我們現在擁有強大的候選產品和候選藥物管道，我們期待通過臨床開發來推進它們，並且擁有更強大的資產負債表來實現這一目標。

So let's talk about Qualigen's technology. Our lead drug candidate, AS1411 is a DNA aptamer, which is the basis of separate programs against cancer and against viral diseases such as COVID-19. AS1411 targets and binds to a protein called nucleolin. This protein is expressed on the surface of cancer cells and enables AS1411 to selectively target these cells without damaging normal cells. In addition, nucleolin has believed to play a role in how viruses attack and utilize cells for replication.

那麼我們來談談Qualigen的技術。我們的主要候選藥物 AS1411 是一種 DNA 適體，它是針對癌症和針對 COVID-19 等病毒性疾病的單獨計劃的基礎。 AS1411 靶向並結合一種稱為核仁素的蛋白質。這種蛋白質在癌細胞表面表達，使 AS1411 能夠選擇性地靶向這些細胞，而不損害正常細胞。此外，核仁素被認為在病毒如何攻擊和利用細胞進行複制方面發揮著重要作用。

With the onset of the pandemic, researchers at the University of Louisville conducted in vitro studies at their prestigious Center for Infectious Disease to evaluate AS1411's effects on COVID-19. These studies demonstrated AS1411's ability to protect cells from the damaging effects of the coronavirus by binding the nucleolin protein.

隨著大流行的爆發，路易斯維爾大學的研究人員在其著名的傳染病中心進行了體外研究，以評估 AS1411 對 COVID-19 的影響。這些研究證明 AS1411 能夠通過結合核仁蛋白來保護細胞免受冠狀病毒的破壞作用。

Subsequently, in June, we signed an exclusive license agreement with the university for the US patent rights covering the treatment of COVID-19 with AS1411. We are aiming to commence a Phase 1/Phase 2 human trial early next year. Although the first indication we are pursuing is for the treatment of COVID-19, we believe AS1411 has the ability to be effective as a broader antiviral therapeutic since other viruses such as HIV, hepatitis, and Ebola also utilize nucleolin.

隨後，在 6 月，我們與該大學簽署了一份獨家許可協議，獲得涵蓋 AS1411 治療 COVID-19 的美國專利權。我們的目標是明年初開始第一階段/第二階段人體試驗。儘管我們追求的第一個適應症是治療 COVID-19，但我們相信 AS1411 有能力作為更廣泛的抗病毒治療藥物，因為 HIV、肝炎和埃博拉病毒等其他病毒也利用核仁素。

While we are still in the preclinical stage, we know AS1411 is safe in humans as it has been administered in Phase 1 and Phase 2 trials to more than 100 patients with advanced cancers, where it was well tolerated with no evidence of severe side effects. In addition, the data demonstrated clinical responses in several of the patients where their cancers disappeared, or tumor shrank substantially. These trials were conducted 10 years ago by a different British company that decided to change its strategic direction and their rights to the compound reverted to Advanced Cancer Therapeutics in the US.

雖然我們仍處於臨床前階段，但我們知道AS1411 對人類是安全的，因為它已在1 期和2 期試驗中對100 多名晚期癌症患者進行了給藥，耐受性良好，沒有嚴重副作用的證據。此外，數據還證明了幾名患者的臨床反應，他們的癌症消失了，或者腫瘤大幅縮小了。這些試驗是由另一家英國公司在 10 年前進行的，該公司決定改變其戰略方向，並將該化合物的權利歸還給美國的 Advanced Cancer Therapeutics。

In 2018, Qualigen obtained exclusive worldwide rights to AS1411, as well as assignment of the original cancer IND from Advanced Cancer Therapeutics. The early promising but incomplete results of AS1411 in cancer trials lead to our cancer drug candidate ALAN, which stands for aptamer-linked anti-nucleolin.

2018年，Qualigen獲得了AS1411的全球獨家權利，以及Advanced Cancer Therapeutics的原始癌症IND轉讓權。 AS1411 在癌症試驗中的早期有希望但不完整的結果催生了我們的癌症候選藥物 ALAN，它代表適體連接的抗核仁素。

ALAN is a combination of AS1411 plus gold nanoparticle using a coating process that we have been doing successfully for almost two decades within our FastPack assay test pouches. This combination dramatically increases its potency. And we believe, its efficacy with the potential to target and destroy tumor cells in a wide variety of cancer types, including leukemia, kidney, pancreatic, brain, and breast, as well as other applications such as enhancing radiation therapy and aiding in tumor scanning.

ALAN 是 AS1411 和金納米顆粒的組合，採用塗層工藝，我們在 FastPack 分析測試袋中已成功使用了近二十年的技術。這種組合極大地提高了其效力。我們相信，它具有靶向和破壞多種癌症類型（包括白血病、腎癌、胰腺癌、腦癌和乳腺癌）中的腫瘤細胞的功效，以及增強放射治療和輔助腫瘤掃描等其他應用。

The gold nanoparticles increase potency by extending the life of time the drug remains in the body. And I am glad to say that although it might seem that gold would make the product very expensive to produce, in fact, the small size of the nanoparticles means this would not be the case.

金納米顆粒通過延長藥物在體內的保留時間來提高藥效。我很高興地說，儘管黃金似乎會使產品的生產成本變得非常昂貴，但事實上，納米粒子的小尺寸意味著情況並非如此。

We have an exclusive worldwide license agreement from the University of Louisville for ALAN. And we have been working with them to advance this program. We plan to conduct the IND-enabling studies against acute myeloid leukemia toward the end of this year and expect to be able to commence Phase 1 human trials in calendar 2021.

我們擁有路易斯維爾大學為 ALAN 頒發的全球獨家許可協議。我們一直在與他們合作推進這個計劃。我們計劃在今年年底開展針對急性髓系白血病的 IND 研究，並預計能夠在 2021 年開始 1 期人體試驗。

In July, we announced the signing of another exclusive license agreement with the University of Louisville. This one for the intellectual property covering the RAS-F, family of RAS oncogene protein-protein interaction inhibitor small molecule candidates.

7月，我們宣布與路易斯維爾大學簽署另一份獨家許可協議。該專利涵蓋 RAS-F（RAS 癌基因蛋白-蛋白相互作用抑製劑小分子候選家族）的知識產權。

RAS genes produce proteins that regulate when and where the body produces new cells. Problems occur when these genes become mutated and the resulting new RAS proteins cannot switch in the off position. These mutations are present in approximately one-third of all cancers, including a high percentage of pancreatic, colorectal, and lung cancers.

RAS 基因產生的蛋白質調節身體產生新細胞的時間和地點。當這些基因發生突變並且產生的新 RAS 蛋白無法切換到關閉位置時，就會出現問題。這些突變存在於大約三分之一的癌症中，包括高比例的胰腺癌、結直腸癌和肺癌。

Current therapies only targets downstream signaling of RAS. But blocking one or two pathways does not provide effective clinical activity because RAS acts like a hub for multiple pathways. The intended mechanism of action of our RAS-F small molecule compounds instead blocks the binding of mutated RAS protein for their effective proteins upstream and stops them from causing further harm.

目前的療法僅針對 RAS 的下游信號傳導。但阻斷一兩條通路並不能提供有效的臨床活性，因為 RAS 的作用就像多個通路的樞紐。我們的 RAS-F 小分子化合物的預期作用機制相反，會阻止突變的 RAS 蛋白與其上游有效蛋白的結合，並阻止它們造成進一步的傷害。

Our plan is to evaluate these compounds in order to identify a lead drug candidate for further development against one or more cancers. We expect to begin preclinical IND-enabling studies in calendar 2021. As I mentioned, we have quite a few ongoing development programs with the University of Louisville. We believe the university is an extremely valuable partner to advance these programs due to their expertise, resources, and ability to conduct clinical studies in a cost-effective manner. We are fortunate to be in a position to partner with them on so many programs.

我們的計劃是評估這些化合物，以確定主要候選藥物，以進一步開發針對一種或多種癌症的藥物。我們預計在 2021 年開始臨床前 IND 支持研究。正如我提到的，我們與路易斯維爾大學有很多正在進行的開發項目。我們相信，由於大學的專業知識、資源以及以具有成本效益的方式進行臨床研究的能力，他們是推進這些項目的極其有價值的合作夥伴。我們很幸運能夠在如此多的項目上與他們合作。

We are also seeking other strategic partnerships to advance clinical development of our promising drug candidates. And we'll always seek opportunities to strategically build our portfolio.

我們還在尋求其他戰略合作夥伴關係，以推進我們有前途的候選藥物的臨床開發。我們將始終尋找機會戰略性地構建我們的產品組合。

Let me point out that all these drug candidates: AS1411, ALAN, and the RAS inhibitor can be considered platform technologies. They all have multiple uses for different types of cancers; and in the instance of AS1411, also infectious diseases. We believe this aspect increases the chances of success in clinical trials when looked at in the aggregate.

讓我指出，所有這些候選藥物：AS1411、ALAN 和 RAS 抑製劑都可以被視為平台技術。它們對於不同類型的癌症都有多種用途；以 AS1411 為例，也包括傳染病。我們相信，從總體上看，這一方面增加了臨床試驗成功的機會。

Further, we believe the potential markets for each of these drug candidates could be very large if we're able to bring them through commercialization. While we cannot guarantee these results, and while everyone knows how difficult and slow the drug development process in the United States is, we are optimistic of our future in therapeutic drug development.

此外，我們相信，如果我們能夠將這些候選藥物商業化，那麼它們的潛在市場可能會非常大。雖然我們不能保證這些結果，雖然每個人都知道美國的藥物開發過程是多麼困難和緩慢，但我們對治療藥物開發的未來感到樂觀。

In addition to our drug candidates, our therapeutics pipeline also includes our STARS blood cleansing system. STARS, which stands for selective target antigen removal system is a blood filtration device product candidate, rather than a drug candidate. With STARS, we would aim to utilize DNA aptamers in our core commercialized FastPack particle coating technology to remove tumor-produced compounds and viruses from the patient's blood.

除了我們的候選藥物外，我們的治療產品線還包括我們的 STARS 血液淨化系統。 STARS，代表選擇性靶抗原去除系統，是血液過濾裝置的候選產品，而不是候選藥物。通過 STARS，我們的目標是在我們的核心商業化 FastPack 顆粒塗層技術中利用 DNA 適配體，從患者血液中去除腫瘤產生的化合物和病毒。

In June, we received a notice of allowance for another patent covering the STARS technology, which utilizes a filtration cartridge designed for use in the standard dialysis machine and contains aptamer-coated microparticles that bind to specific agents in circulating blood for targeted removal. I am pleased to report that this new patent issued today. Proof of concept for STARS has been established with in vitro testing. And this program is in the early stages of development.

6 月，我們收到了另一項涵蓋STARS 技術的專利許可通知，該技術採用專為標準透析機設計的過濾筒，並包含適配體塗層微粒，可與循環血液中的特定試劑結合以進行靶向去除。我很高興地報告今天發布了這項新專利。 STARS 的概念驗證已通過體外測試建立。該計劃正處於開發的早期階段。

With respect to our diagnostics business, as I mentioned, we have been commercializing the FastPack system for almost 20 years. Except to a limited number of direct customers, we sell FastPack to our distributor, Sekisui Diagnostics. Sekisui has been a supportive partner of ours since 2016 and also holds over 9% of our outstanding common stock. Sekisui serves as our exclusive distributor for FastPack worldwide, except in China until May of 2022. Therefore, they're key to the amount and pace of products we sell.

至於我們的診斷業務，正如我提到的，我們將 FastPack 系統商業化已有近 20 年了。除了少數直接客戶外，我們還向我們的經銷商 Sekisui Diagnostics 出售 FastPack。自 2016 年以來，積水一直是我們的支持合作夥伴，還持有我們超過 9% 的已發行普通股。截至 2022 年 5 月，Sekisui 是 FastPack 在全球範圍內（中國除外）的獨家經銷商。因此，它們對於我們銷售產品的數量和速度至關重要。

In addition, we are working to assist distribution through lead generation and marketing. For instance, last month, Mike Haynes, the Pro Football Hall of Fame and College Football Hall of Fame inductee signed with Qualigen as an advisor and spokesman for the FastPack system. One of the tests run on the FastPack system is for PSA, which, as you know, is a marker for prostate cancer.

此外，我們還致力於通過潛在客戶開發和營銷來協助分銷。例如，上個月，職業橄欖球名人堂和大學橄欖球名人堂入選者 Mike Haynes 與 Qualigen 簽約，擔任 FastPack 系統的顧問和發言人。 FastPack 系統上運行的一項測試是 PSA，正如您所知，PSA 是前列腺癌的一種標誌物。

Mike received an elevated PSA result using a FastPack tested at 2008 Hall of Fame event sponsored by Qualigen and the American Urological Association and was subsequently diagnosed with prostate cancer. And he underwent treatment and made a full recovery. Ever since then, Mike has been a prominent advocate for prostate cancer testing. And he often tells people that the FastPack testing system saved his life. We look forward to working with Mike on our outreach efforts and sponsorship opportunities with the NFL and other professional sports organizations for the FastPack system.

邁克在 2008 年由 Qualigen 和美國泌尿外科協會贊助的名人堂活動中使用 FastPack 測試後，PSA 結果升高，隨後被診斷患有前列腺癌。他接受了治療並完全康復。從那時起，邁克一直是前列腺癌檢測的傑出倡導者。他經常告訴人們，FastPack 測試系統救了他的命。我們期待與 Mike 合作，為 FastPack 系統提供 NFL 和其他專業體育組織的外展工作和讚助機會。

In June, we submitted to the FDA for emergency use authorization, or EUA for our COVID-19 antibody test on our FastPack PRO System, which is an upgraded version of FastPack meant to run more complex tests. Subsequently, we submitted an official notification to the FDA of our plan to commence sales of EUAs pending. We are allowed to do this, and we are confident that the FDA will grant the emergency use authorization request for this product.

6 月，我們向 FDA 提交了緊急使用授權或 EUA，以在 FastPack PRO 系統上進行 COVID-19 抗體測試，該系統是 FastPack 的升級版本，旨在運行更複雜的測試。隨後，我們向 FDA 提交了一份關於我們開始銷售 EUA 計劃的正式通知。我們被允許這樣做，並且我們有信心 FDA 將批准該產品的緊急使用授權請求。

Limited shipments of our FastPack PRO with our COVID-19 antibody test commenced at the end of last month. And we are working to install full-scale manufacturing of our new FastPack PRO analyzers.

帶有 COVID-19 抗體測試的 FastPack PRO 於上月底開始限量發貨。我們正在努力安裝新型 FastPack PRO 分析儀的全面生產。

In addition to our own validation studies, the University of Louisville has begun conducting independent validation studies with hundreds of patient samples using our COVID-19 antibody test on the FastPack PRO System. These validation studies are expected to continue for several months as a range of patient types and various stages of the disease will be examined.

除了我們自己的驗證研究之外，路易斯維爾大學還開始使用我們在 FastPack PRO 系統上進行的 COVID-19 抗體測試對數百名患者樣本進行獨立驗證研究。這些驗證研究預計將持續幾個月，對一系列患者類型和疾病的不同階段進行檢查。

Over the next few months, we expect to increase production capacity with the goal of having analyzers and test kits positioned to assist in the fight against the novel coronavirus. We believe these testing resources are needed, especially as the pandemic enters the vaccine stage, where drug supplies will likely need to be rationed and an accurate antibody test would be most useful.

在接下來的幾個月裡，我們預計將提高產能，目標是提供分析儀和測試套件來協助對抗新型冠狀病毒。我們認為這些測試資源是必要的，特別是當大流行進入疫苗階段時，藥物供應可能需要配給，而準確的抗體測試將是最有用的。

Please understand that our FastPack PRO COVID-19 antibody test, like all our tests in the FastPack family are blood tests, not swab tests, and need to be administered by a credentialed healthcare professional. FastPack provides rapid results in the case of the COVID-19 antibody in about 10 minutes. Our analyzer process is one test at a time, not dozens of tests simultaneously as in large laboratory settings. Large reference laboratories, of course, cannot give results to the patient in 10 minutes at the point-of-care.

請理解，我們的 FastPack PRO COVID-19 抗體測試，就像我們 FastPack 系列中的所有測試一樣，都是血液測試，而不是拭子測試，並且需要由有資格的醫療保健專業人員進行。對於 COVID-19 抗體，FastPack 在大約 10 分鐘內即可提供快速結果。我們的分析儀過程一次進行一項測試，而不是像大型實驗室環境中那樣同時進行數十項測試。當然，大型參考實驗室無法在現場 10 分鐘內向患者提供結果。

The potential market for our product is quite large. However, it will take time to ramp up production and place our analyzers in optimal settings for its unique characteristics. We want our shareholders to view our COVID-19 antibody test as just one of many areas where Qualigen seeks to make a difference in people's health and lives.

我們產品的潛在市場是相當大的。然而，提高產量並將我們的分析儀置於其獨特特性的最佳設置需要時間。我們希望我們的股東將我們的 COVID-19 抗體測試視為 Qualigen 尋求改變人們的健康和生活的眾多領域之一。

Along these lines, in an effort to continue to expand our test menu for FastPack PRO, we will be offering another test, cellular fibronectin, or CFN for short, which is a new stroke assessment test developed as a companion diagnostic for Prediction Sciences LLC. This test is expected to obtain CE Mark in the next month or two for commercialization in Europe and other geographies that recognize CE Mark.

沿著這些思路，為了繼續擴展FastPack PRO 的測試菜單，我們將提供另一種測試，即細胞纖連蛋白（簡稱CFN），這是一種新的中風評估測試，作為Prediction Sciences LLC 的伴隨診斷而開發。該測試預計將在未來一兩個月內獲得 CE 標誌，以便在歐洲和其他承認 CE 標誌的地區進行商業化。

Even with that news and progress with the FastPack system, I'd like to be clear that Qualigen is primarily a therapeutics company. The bulk of our resources are being invested in therapeutic product candidates, because that is where we see the maximum potential return, the largest market opportunities, and the best path to creating value for our stockholders.

即使有了這些消息以及 FastPack 系統的進展，我仍想澄清的是，Qualigen 主要是一家治療公司。我們的大部分資源都投資於候選治療產品，因為這是我們看到最大潛在回報、最大市場機會以及為股東創造價值的最佳途徑的地方。

The foundation of this company over the years has been diagnostics, which is clearly a very important scrutinized area right now. Our future, however, is in developing drugs and other technologies that may one day cure or defeat cancer and infectious diseases.

多年來，這家公司的基礎是診斷，這顯然是目前一個非常重要的審查領域。然而，我們的未來是開發藥物和其他技術，有一天可能會治愈或戰勝癌症和傳染病。

With that brief overview, let me turn the call over to Christopher Lotz for a discussion of the company's financials. Chris?

簡單概述後，讓我將電話轉給克里斯托弗·洛茨 (Christopher Lotz)，討論公司的財務狀況。克里斯？

Thanks, Michael. And good afternoon, everyone. As Michael mentioned, after the end of the recent fiscal quarter, we raised $18 million in two registered direct offerings at market prices to a single institutional investor. With the net proceeds from these offerings, along with cash raised at the closing of our May 22, 2020, reverse merger transaction, we currently held approximately $16 million in cash even after paying expenses and past obligations.

謝謝，邁克爾。大家下午好。正如邁克爾提到的，在最近的財政季度結束後，我們以市場價格向單一機構投資者進行了兩次註冊直接發行，籌集了 1800 萬美元。憑藉這些發行的淨收益，加上 2020 年 5 月 22 日反向併購交易結束時籌集的現金，即使在支付費用和過去的債務之後，我們目前仍持有約 1600 萬美元的現金。

We currently have only $1 million in remaining debt made up of mostly of funds received from the Payroll Protection Program before the reverse merger and financed insurance premiums. Our cash position is sufficient to fund operations at our current expected pace into calendar year 2022. New opportunities or unforeseen challenges could change that runway forecast.

目前，我們只剩下 100 萬美元的剩餘債務，其中大部分是藉殼上市前從薪資保護計劃收到的資金以及融資保險費。我們的現金狀況足以為 2022 年按照目前的預期速度進行運營提供資金。新的機遇或不可預見的挑戰可能會改變跑道預測。

We have a little over 21 million common shares outstanding. 3.6 million of these shares were issued in the two recent financings, and 3.8 million shares were issued in exchange for voluntary conversion of approximately two-thirds of the total outstanding preferred stock since June 30.

我們已發行的普通股略多於 2100 萬股。其中360萬股在最近的兩次融資中發行，其中380萬股是為了換取自6月30日以來已發行優先股總數約三分之二的自願轉換。

We also currently have outstanding 3.7 million employee options and 9.8 million warrants, inclusive of 4.7 million warrants that caused a significant non-cash reported loss for the company in the current quarter due to accounting rules. I'll discuss that further after a brief look at revenue and expenses.

目前，我們還擁有未償還的 370 萬份員工期權和 980 萬份認股權證，其中包括由於會計規則而導致公司本季度出現重大非現金報告損失的 470 萬份認股權證。在簡要了解收入和支出後，我將進一步討論這一點。

Total revenue for the current quarter was approximately $900,000, which is down $600,000 from the same period in 2019. Sales were negatively affected by the COVID-19 pandemic, resulting in fewer non-essential patient visits to physician offices, clinics, and small hospitals, which reduced the number of FastPack tests performed.

本季度的總收入約為 90 萬美元，比 2019 年同期減少了 60 萬美元。銷售受到 COVID-19 大流行的負面影響，導致前往醫生辦公室、診所和小型醫院的非必要患者就診次數減少，這減少了執行的FastPack 測試的數量。

All revenues in both periods came from the sale of our diagnostic products, both through our exclusive distributorship with Sekisui and to a limited number of customers that we sell to directly. Reimbursement challenges also affect our diagnostic product sales.

這兩個時期的所有收入都來自診斷產品的銷售，既通過我們與積水的獨家經銷權，又向我們直接銷售的有限數量的客戶銷售。報銷挑戰也影響了我們的診斷產品銷售。

On the expense side, we spent $2 million on G&A in the current period compared with about $300,000 in the prior year period. The increase is largely due to one-time expenses related to the reverse merger transaction that closed in late May, as well as other public company expenses not incurred in the prior year period.

在費用方面，本期我們在一般管理費用上花費了 200 萬美元，而去年同期約為 30 萬美元。這一增長主要是由於與 5 月下旬完成的反向併購交易相關的一次性費用，以及上一年期間未發生的其他上市公司費用。

Investors looking at our G&A expenses year-over-year should keep in mind that the comparison is skewed because it compares this year's public company to last year's private company Qualigen, Inc. expenses. And just to be clear, our fiscal years end on March 31. Therefore, the quarter ending June 30 was our first fiscal quarter.

逐年查看我們的 G&A 費用的投資者應該記住，這種比較是有偏差的，因為它是將今年的上市公司與去年的私營公司 Qualigen, Inc. 的費用進行比較。需要明確的是，我們的財政年度於 3 月 31 日結束。因此，截至 6 月 30 日的季度是我們的第一個財政季度。

Payroll costs also increased in the quarter and may continue to increase in future periods as we expand. Total R&D expense was approximately $600,000 in the current period compared with $700,000 for the prior year period. In the current quarter, we had higher expenses than last year related to our sponsored therapeutics research at the University of Louisville, which totaled about $350,000 compared to about $200,000 last year.

本季度工資成本也有所增加，並且隨著我們的擴張，未來一段時間可能會繼續增加。本期研發費用總額約為 600,000 美元，而去年同期為 700,000 美元。本季度，我們在路易斯維爾大學贊助的治療研究相關費用比去年更高，總計約 35 萬美元，而去年約為 20 萬美元。

On the diagnostics side, we had COVID-19 antibody test development costs of about $250,000 in the current quarter compared to the year-ago period, which included about $500,000 of costs associated with our diagnostic development projects with Sekisui that was terminated in May 2019. We expect our R&D expenses to increase in future periods as we accelerate development of multiple drug candidates and shift our overall R&D spending towards therapeutics.

在診斷方面，與去年同期相比，本季度我們的 COVID-19 抗體測試開發成本約為 25 萬美元，其中包括與 Sekisui 於 2019 年 5 月終止的診斷開發項目相關的約 50 萬美元成本。我們預計，隨著我們加速多種候選藥物的開發並將整體研發支出轉向治療藥物，我們的研發費用在未來一段時間內將會增加。

Loss from operations in the first quarter of our fiscal 2021 increased to $2.6 million from a $500,000 loss from operations for the prior year period. Mainly due to the higher G&A expenses, along with reduced gross profit due to the decline in product sales. In a very disproportionate way though, our net loss in the first quarter of fiscal 2021 was $18.6 million compared with a net loss of $600,000 for the same period last year.

2021 財年第一季度的運營虧損從上年同期的 50 萬美元增至 260 萬美元。主要是由於管理及行政費用增加，以及產品銷量下降導致毛利潤減少。然而，我們 2021 財年第一季度的淨虧損為 1860 萬美元，而去年同期的淨虧損為 60 萬美元，這是非常不成比例的。

As I mentioned earlier, this significant change was primarily a result of a non-cash charge of $16.2 million [when] GAAP rules, we had to record in this year's first quarter a derivative liability related to a series of warrants we originally issued in 2004. This GAAP rule created and will continue to create significant distortion in our balance sheet and P&L due to external factors such as the price of our stock. We will seek ways to change the underlying factual positions as we can and in compliance with GAAP, reduce or eliminate this non-cash line item in the future.

正如我之前提到的，這一重大變化主要是由於1620 萬美元的非現金費用所致，根據GAAP 規則，我們必須在今年第一季度記錄與我們最初於2004 年發行的一系列認股權證相關的衍生負債。由於股票價格等外部因素，這一 GAAP 規則造成並將繼續對我們的資產負債表和損益表造成嚴重扭曲。我們將尋求方法，在符合公認會計原則的情況下，盡可能改變潛在的事實狀況，減少或消除未來的非現金項目。

In conclusion, diagnostics is a competitive market facing the headwinds of declining reimbursements from Medicare and private insurers, as well as shorter-term pandemic effects. We do not believe that revenue or profitability from our diagnostics business is a critical indicator of the long-term value of Qualigen. Rather, progress towards the potential commercialization of one or more of our drug candidates is a better way to measure our company. And said another way, we believe our peers are other promising early-stage biotech companies with multi-product pipelines, strong academic partnerships, and sufficient capital to fund operations into calendar year 2022.

總之，診斷是一個競爭激烈的市場，面臨著醫療保險和私人保險公司報銷下降以及短期流行病影響的不利因素。我們認為診斷業務的收入或盈利能力並不是 Qualigen 長期價值的關鍵指標。相反，我們的一種或多種候選藥物的潛在商業化進展是衡量我們公司的更好方法。換句話說，我們相信我們的同行是其他有前途的早期生物技術公司，擁有多產品管道、強大的學術合作夥伴關係以及足夠的資本來為 2022 年的運營提供資金。

With that, I'd like to open up the call for questions. Operator?

至此，我想開始提問。操作員？

James Molloy, Alliance Global Partners.

詹姆斯·莫洛伊，聯盟全球合作夥伴。

Hey, guys. Thanks for taking my questions. I have a quick follow up. I know that as Chris just said, the therapeutics are more important than diagnostics, which is [rest of you are] selling currently.

大家好。感謝您回答我的問題。我有一個快速跟進。我知道正如克里斯剛才所說，治療方法比診斷方法更重要，診斷方法目前正在銷售。

[Sort of] walk through a little bit on the FastPack PRO. I know you started shipping that. Is there any -- when do you anticipate sort of starting to book revenues on that? Is there any idea -- any guidance you can give on sort of pricing, number of tests, and sort of the potential size of the FastPack PRO here in the short term?

[有點] 簡單介紹一下 FastPack PRO。我知道你開始運送那個。您預計什麼時候開始在這方面登記收入？您是否可以就 FastPack PRO 的定價、測試數量以及短期內的潛在規模提供任何想法？

Hey, Jim. Thanks for the question. We expect to recognize revenue from the sale of the COVID-19 antibody tests in this quarter. But we would expect them to gradually increase over the following quarters as we ramp up manufacturing of the PRO analyzer. But we're not going to provide any specific guidance right now on pricing or sales numbers.

嘿，吉姆。謝謝你的提問。我們預計將在本季度確認銷售 COVID-19 抗體測試的收入。但隨著我們加大 PRO 分析儀的生產力度，我們預計它們將在接下來的幾個季度逐漸增加。但我們現在不會提供有關定價或銷售數字的任何具體指導。

While we are actively working to get this important product into the market, I need to point out that we can't expect to build a long-term business around just the COVID-19 antibody tests. I think an equal or more important endeavor -- and this goes to what we were talking about earlier is what we are doing on the therapeutic side with AS1411 as this drug candidate shows promise for helping with a multitude of viral-based diseases. And I can't stress that enough and not just COVID-19.

雖然我們正在積極努力將這一重要產品推向市場，但我需要指出的是，我們不能指望僅圍繞 COVID-19 抗體測試建立長期業務。我認為同樣或更重要的努力 - 這與我們之前討論的 AS1411 治療方面所做的工作有關，因為這種候選藥物顯示出有助於治療多種病毒性疾病的希望。我必須強調這一點，而不僅僅是 COVID-19。

Understood. And on the ALAN, I know that you guys are anticipating. Is it still on track for the IND filing here in the current year? And I apologize, in the AS1411, the SARS-CoV-2 treatment, what -- when do you expect starting the IND and starting human trials?

明白了。在 ALAN 上，我知道你們都在期待。今年的 IND 申請是否仍按計劃進行？我很抱歉，在 AS1411 SARS-CoV-2 治療中，您預計什麼時候開始 IND 並開始人體試驗？

All right. So I'll take the second one first, because that's really the lead. AS1411, as it's going to be applied to COVID-19, we're aiming to file the IND for that in October. And we're aiming to begin the human trials for COVID-19 early in 2021 -- in calendar 2021.

好的。所以我會先選擇第二個，因為那確實是領先的。 AS1411，由於它將應用於 COVID-19，我們的目標是在 10 月份提交 IND。我們的目標是在 2021 年初（也就是 2021 年日曆）開始針對 COVID-19 的人體試驗。

With ALAN, for acute myeloid leukemia, we are aiming to file the IND for that sometime in the second quarter of calendar 2021 with the human trials to follow not too long after that.

對於針對急性髓系白血病的 ALAN，我們的目標是在 2021 年第二季度的某個時候提交 IND，並在不久之後進行人體試驗。

And could you speak a little bit about the safety work -- the Phase one safety work that Antisoma has done on AS1411 that gives you the confidence to go right into the Phase 2?

您能談談安全工作嗎？Antisoma 在 AS1411 上所做的第一階段安全工作讓您有信心進入第二階段？

Yes. Antisoma has done Phase 1, plus they had done several Phase 2 trials on advanced cancer patients who were immune compromised, and their health was was very deteriorated. And the safety profile on this drug as they did, it was excellent. In fact, they were never able to reach a maximum tolerated dose on this drug. So that's one of the beauties of aptamers is the safety profile was so good.

是的。 Antisoma 已經完成了第一階段，此外他們還對免疫受損的晚期癌症患者進行了幾項第二階段試驗，他們的健康狀況非常惡化。而且這種藥物的安全性非常好。事實上，他們從未達到這種藥物的最大耐受劑量。因此，適體的優點之一就是安全性非常好。

And then a question for Chris. And I know that there were a lot of one-timers and sort of non-cash numbers in the current quarter. How much of the G&A really -- obviously, the fair value of the warrant liability is non-cash -- big non-cash. But in G&A, the [$2] million, I think you call out in the Q maybe about $800,000 or $1 million of that is non-recurring. How much of -- can you give us an idea of what sort of the [goal], the run rate is as a public company on the G&A line going forward?

然後問克里斯一個問題。我知道本季度有很多一次性的和非現金的數字。顯然，認股權證負債的公允價值有多少是非現金的，很大一部分是非現金的。但在一般管理費用中，[2]百萬美元，我想你在問題中指出的可能是大約 80 萬美元或 100 萬美元是非經常性的。您能否告訴我們，作為一家上市公司，未來 G&A 線的運行率是多少？

Sure, Jim. Actually, I would not exclude any of these one-time costs that were mentioned in the Q going forward. Because any savings from the non-recurring G&A costs may be offset by the higher costs in future quarters of being a public company.

當然，吉姆。事實上，我不會排除未來問題中提到的任何一次性成本。因為非經常性管理費用節省的任何費用都可能被上市公司未來幾個季度的更高成本所抵消。

And then the last couple of questions, [and I'll] get back in the queue. $16 million on the balance sheet is a good number. Where -- what' sort of a burn rate you see going forward to the next couple of years and what kind of runway does $16 million gets you guys currently?

然後最後幾個問題，[我會]回到隊列中。資產負債表上的 1600 萬美元是一個不錯的數字。您認為未來幾年的燒錢率是多少？目前 1600 萬美元可以給你們帶來什麼樣的跑道？

Yes, we feel that the $16 million is approximately two years of run rate for us. On a cash basis after revenue from diagnostic sales, we currently expect cash burn for G&A and R&D expenses to be about $2 million per quarter or less at our current rate, which is about, as I said, two years of run rate. However, this could change as new opportunities or unforeseen challenges arise.

是的，我們認為 1600 萬美元大約相當於我們兩年的運行費用。在扣除診斷銷售收入後的現金基礎上，我們目前預計G&A 和研發費用的現金消耗約為每季度200 萬美元或更少，按照我們目前的速度計算，正如我所說，這大約是兩年的運行速度。然而，隨著新機遇或不可預見的挑戰的出現，這種情況可能會發生變化。

Great. Thank you for taking the questions.

偉大的。感謝您提出問題。

David Bautz, Zacks Small Cap Research.

大衛·鮑茨 (David Bautz)，Zacks 小盤股研究公司。

Hey. Good afternoon, everyone. Mike, I was wondering if you could maybe give a broad outline of what the COVID clinical trial would look like. Maybe just how many patients you're thinking and then maybe what potential outcomes you might be looking at?

嘿。大家下午好。邁克，我想知道您能否大致概述一下新冠肺炎臨床試驗的情況。也許您正在考慮有多少患者，然後您可能會考慮哪些潛在結果？

Sure. Excellent question, David. In broad terms, what we're looking at is a clinical trial with several arms. One would be with AS1411 alone, and another one would be AS1411 plus standard-of-care, which in this case today is remdesivir. And we're looking right now at a total number of patients of about 500 across about 20 sites.

當然。很好的問題，大衛。從廣義上講，我們正在研究的是多組臨床試驗。一種是單獨使用 AS1411，另一種是 AS1411 加上標準護理，在今天的例子中是瑞德西韋。我們現在正在查看大約 20 個地點的大約 500 名患者。

One of the interesting things about doing a COVID-19 trial right now is that patients are not in short supply. And the endpoints come fairly quickly. So you get endpoints at like 10 days or so. If you look at, as an example, the remdesivir trial, they did like 1,060 patients and they were able to get that trial done in a couple of months. So, I mean, that's really what we're looking at there in broad terms.

目前進行 COVID-19 試驗的一個有趣的事情是患者並不短缺。而且終點來得相當快。所以你會在大約 10 天左右得到終點。以瑞德西韋試驗為例，他們確實喜歡了 1,060 名患者，並且能夠在幾個月內完成該試驗。所以，我的意思是，這確實是我們從廣義上看待的問題。

Okay. Now for ALAN, do you foresee that being used as a monotherapy in AML, or maybe part as a combination therapy?

好的。現在，對於 ALAN，您預計它會被用作 AML 的單一療法，還是可能作為聯合療法的一部分？

Well, we would love to see it as a monotherapy. However, AML, like most cancers is very heterogeneous, meaning that there are multiple clones involved in all of these cancers, these things mutate, different phenotypes and so on. And what we see with all sorts of cancers is the most effective therapies tend to be combination therapies. And so, it may be that ultimately, it's a combination therapy with ALAN plus something, let's say, like in the case of AML, a chemotherapeutic agent like cytarabine.

嗯，我們很樂意將其視為單一療法。然而，像大多數癌症一樣，AML 是非常異質的，這意味著所有這些癌症都涉及多個克隆、這些東西會發生突變、不同的表型等等。我們發現，對於各種癌症，最有效的療法往往是聯合療法。因此，最終可能是 ALAN 加上某種藥物的聯合療法，比如在 AML 的情況下，使用阿糖胞苷等化療藥物。

All right. And for the RAS-F program, I was just wondering if you could tell us where exactly that is in the development stage? And then when we might expect the next update and then what that update would most likely be?

好的。至於 RAS-F 項目，我只是想知道您能否告訴我們具體處於開發階段嗎？然後我們什麼時候可以期待下一次更新，那麼更新最有可能是什麼？

Sure. RAS-F is -- as I mentioned earlier, it's a family of compounds. It's approximately 160 different compounds. And of those compounds, we are now in the process working with the University of Louisville to narrow that down to one lead candidate that we are going to take forward into the pre-IND studies. And we expect -- we're aiming to do those pre-IND studies beginning early in 2021. So at that point, I think we would be looking to provide everyone with an update as to where we are with the program and what the timeline would be more granular as we go forward.

當然。正如我之前提到的，RAS-F 是一個化合物家族。它大約有 160 種不同的化合物。在這些化合物中，我們現在正在與路易斯維爾大學合作，將範圍縮小到一種主要候選藥物，我們將把它納入 IND 前研究。我們預計，我們的目標是在 2021 年初開始進行 IND 前研究。因此，到那時，我認為我們將尋求向每個人提供有關該計劃進展情況和時間表的最新信息隨著我們的前進，將會更加細化。

Okay, great. Thanks for taking the questions.

好的，太好了。感謝您提出問題。

Thank you.

謝謝。

This concludes our question-and-answer session. I would like to turn the conference back over to Michael Poirier for any closing remarks.

我們的問答環節到此結束。我想將會議轉回邁克爾·普瓦里爾（Michael Poirier）發表閉幕詞。

Thank you. I'd like to thank everyone for participating on today's call and for your questions. We look forward to keeping you updated on our progress and intend to hold periodic conference calls like this one. In the meantime, we appreciate your continued interest in Qualigen Therapeutics. Thank you again for your time and for your support.

謝謝。我要感謝大家參加今天的電話會議並提出問題。我們期待向您通報我們的最新進展，並打算定期舉行這樣的電話會議。同時，我們感謝您對 Qualigen Therapeutics 的持續關注。再次感謝您的寶貴時間和支持。

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。您現在可以斷開連接。