Acurx Pharmaceuticals Inc (ACXP) 2024 Q3 法說會逐字稿

Greetings and welcome to the Accurate Pharmaceuticals Inc third quarter, 2024 results and business update conference call at this time. All participants are in a listen-only mode, a brief question and answer session will follow the formal presentation. Should anyone require operator assistance during the conference? Please press star zero on your telephone keypad as a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Robert Shawah, Chief Financial Officer. Thank you. You may begin.

您好，歡迎此時參加 Accurate Pharmaceuticals Inc 2024 年第三季業績和業務更新電話會議。所有參與者均處於僅聽模式，正式演示後將進行簡短的問答環節。會議期間是否有人需要操作員協助？請按電話鍵盤上的星號零作為提醒，本次會議正在錄製中。現在我很高興向您介紹主持人，財務長羅伯特·沙瓦 (Robert Shawah)。謝謝。你可以開始了。

Thank you. Good morning and welcome to our call this morning, we issued a press release providing financial results and company highlights for the third quarter of 2024 which is available on our website at Aerex Pharma dotcom.

謝謝。早安，歡迎今天早上接到我們的電話，我們發布了一份新聞稿，提供 2024 年第三季度的財務業績和公司亮點，可在我們的 Aerex Pharma dotcom 網站上獲取。

Joining me today is Dave Lucci, President and CEO of ACX.

今天加入我的是 ACX 總裁兼執行長 Dave Lucci。

We'll give a corporate update and outlook after that. I'll provide some highlights of the financials for the quarter ended September 30th 2024 and then turn the call back over to Dave for his closing remarks.

之後我們將提供公司最新情況和展望。我將提供截至 2024 年 9 月 30 日的季度財務數據的一些要點，然後將電話轉回給 Dave，讓其結束語。

As a reminder during today's call, we'll be making certain forward-looking statements.

在今天的電話會議中提醒您，我們將做出某些前瞻性聲明。

These forward-looking statements are based on current information, assumptions, estimates and projections about future events, they are subject to change and involve a number of risks and uncertainties that may cause actual results to differ materially from those contained in the forward-looking statements.

這些前瞻性陳述是基於有關未來事件的當前資訊、假設、估計和預測，可能會發生變化，並涉及許多風險和不確定性，可能導致實際結果與前瞻性陳述中包含的結果有重大差異。

Investors should consider these risks and other information described in our filings made with the securities and exchange commission including our quarterly report on form 10-Q which we filed on Tuesday, November 12th, 2024.

投資者應考慮這些風險以及我們向美國證券交易委員會提交的文件中描述的其他信息，包括我們於 2024 年 11 月 12 日星期二提交的 10-Q 表格季度報告。

You are cautioned not to place undue reliance on these forward-looking statements and Aerex disclaims any obligation to update such statements at any time in the future.

請您注意不要過度依賴這些前瞻性陳述，且 Aerex 不承擔在未來隨時更新此類陳述的義務。

This conference call contains time sensitive information that's accurate only as of the date of this live broadcast today. November 13th, 2024.

本次電話會議包含時間敏感訊息，僅截至今天直播之日準確。2024 年 11 月 13 日。

I'll now turn the call over to Dave. Dave.

我現在將把電話轉給戴夫。戴夫.

Thanks Rob, good morning, everyone and thanks for joining us to review our financial results for the third quarter of 2024. And also to hear some very exciting recent updates. Then we'd be pleased to take any questions first. I'll summarize some of our key activities for the third quarter of 24 or in some cases shortly thereafter.

謝謝 Rob，大家早安，謝謝您與我們一起回顧 2024 年第三季的財務表現。還可以聽到一些非常令人興奮的最新更新。那我們很樂意先回答任何問題。我將總結 24 月第三季或不久後的某些情況下的一些關鍵活動。

In July, results from the ibese Aals. That phase two clinical trial in patients with C diff infection were presented at the 17th biennial Congress of the Anao Society of the Americas by Tran Eubank Ph D research, assistant professor at the University of Houston College of Pharmacy.

7 月，ibese Aals 成績公佈。休士頓大學藥學院助理教授 Tran Eubank 博士研究人員在第 17 屆美洲 Anao 學會兩年一度的大會上介紹了這項針對艱難梭菌感染患者的二期臨床試驗。

Tarin delivered an oral presentation entitled, Clinic Clinical Efficacy of A Bezos sta and CDI results from phase two trials.

Tarin 發表了題為《貝佐斯 sta 的臨床臨床療效和二期試驗的 CDI 結果》的口頭報告。

Okay.

好的。

Also in July, the US PTO granted Arix a new patent for the Idol sta which specifically encompasses the treatment of C of ale infection while reducing recurrence of infection and improving the health of the gut microbiome.

同樣在 7 月，美國專利商標局 (PTO) 授予 Arix 一項關於 Idol sta 的新專利，該專利具體涵蓋了麥芽糖桿菌感染的治療，同時減少感染復發並改善腸道微生物群的健康。

This patent expires in June 2042 subject to extension if any and we think will provide an important downstream competitive advantage.

該專利將於 2042 年 6 月到期，如有延期，我們認為這將提供重要的下游競爭優勢。

We also filed other patent applications with the USPTO in the third quarter, but we'll discuss those down the road if and when these patents are issued in August following our successful end of phase two clinical meeting with the FDA which confirms our phase three clinical trial program readiness and for FDA requirements, we submitted a manufacturing request to the FDA for a meeting to review our manufacturing processes and specifications for drug substance and final product packaging.

我們也在第三季向USPTO 提交了其他專利申請，但在我們與FDA 成功結束了第二階段臨床會議並確認了我們的第三階段臨床後，我們將在8 月討論這些專利是否以及何時發布。

This would allow us to move forward to phase three clinical trials FDA granted a meeting date in late October which we did not need because of our successful pre meeting correspondence with the FDA. So from a regulatory perspective, we're delighted to announce CMC readiness for phase three. In addition to FDA agreement on our clinical plan forward for phase three in September, a presentation was given by Aerex Executive Chairman Bob de Lucia at the World Antimicrobial Resistance Scientific Congress held in Philadelphia.

這將使我們能夠推進第三階段臨床試驗，FDA 批准了 10 月下旬的會議日期，但由於我們在會議前與 FDA 成功通信，所以我們不需要這個日期。因此，從監管角度來看，我們很高興宣布 CMC 已做好第三階段的準備。除了 FDA 就我們 9 月第三階段的臨床計劃達成一致外，Aerex 執行主席 Bob de Lucia 還在費城舉行的世界抗菌素抗藥性科學大會上做了演講。

As many of you may know Bob has over 50 years, industry experience and new antibiotic development and commercialization and is responsible for our clinical development programs including Frey as a pos that in his presentation at the Innovation Showcase session, Bob highlighted that we have a complete road map, not only for the required components of our phase three clinical program, but also what's required for ultimate filing of an NDA which is to be followed by submissions for marketing authorizations in other countries around the world. Bob also presented an update on the company's pre clinical grant positive selective spectrum program for systemic oral and IV treatment of other grant positive infections including mesa VRE and DRSP Bob summarized our progress stating that we've made substantial progress to our lead compound selection of our grand positive IV and oral compounds.

你們中的許多人可能都知道，鮑勃擁有50 多年的行業經驗和新抗生素開發和商業化經驗，負責我們的臨床開發項目，其中包括弗雷，鮑勃在創新展示會議上的演講中強調，我們擁有完整的臨床開發計劃。鮑勃也介紹了該公司臨床前授予陽性選擇譜計劃的最新情況，該計劃用於全身口服和靜脈注射治療其他授予陽性感染，包括mesa VRE 和DRSP 鮑勃總結了我們的進展，指出我們在我們的先導化合物選擇方面取得了實質進展盛大的積極靜脈注射和口服化合物。

Our current focus is to prioritize the oral form for acute bacterial skin and skin structure, staph infections including MSA to speed lead product selection and advancement to clinical trials.

我們目前的重點是優先考慮口服形式治療急性細菌性皮膚和皮膚結構、葡萄球菌感染（包括 MSA），以加快主導產品的選擇和臨床試驗的進展。

We also participated at the eighth annual C difficile symposium or ICDS in Bled Slovenia, which is the premier global venue for the review of C difficile research at the ICDS meeting. Two presentations were made on our behalf.

我們也參加了在斯洛維尼亞布萊德舉行的第八屆艱難梭菌年度研討會或 ICDS，這是 ICDS 會議上審查艱難梭菌研究的全球首要場所。我們代表我們做了兩場演講。

First, Dr Kevin Gary, Professor and chair, University of Houston College of Pharmacy made a presentation on our behalf regarding I Bez Auls, that's phase two B results and its preservation of key bacterial species, which was an unexpected finding of a unique microbiome signature and two Vancomycin treated patients in the phase two B trial who experienced recurrence of CDI.

首先，休士頓大學藥學院教授兼主席 Kevin Gary 博士代表我們做了關於 I Bez Auls 的演講，這是第二階段 B 結果及其對關鍵細菌物種的保存，這是對獨特微生物組特徵的意外發現兩名在B 期試驗中接受萬古黴素治療的患者出現了CDI 復發。

Since these changes were evident and observed early during treatment and then consistently until the end of therapy, they may be predictive of pending CDI recurrence and suggest the need to modify therapy accordingly. As we move ahead to our planned international Phase three clinical trials, we will continue to evaluate what we call our predictive model to determine if there may be a pathway forward toward commercialization as a new diagnostic tool or test kit, if you will.

由於這些變化在治療早期就很明顯並觀察到，然後一直持續到治療結束，因此它們可能預示著即將發生的 CDI 復發，並表明需要相應地修改治療。當我們推進計劃的國際三期臨床試驗時，我們將繼續評估我們所謂的預測模型，以確定是否有可能作為新的診斷工具或測試套件商業化（如果您願意的話）。

Second in bled Slovenia. Doctor We Klaus Schmitz, associate professor at Lyd University Medical Center in Holland delivered a presentation on the mechanism of action of P three C inhibitors.

第二名是斯洛維尼亞布萊德。荷蘭Lyd大學醫學中心副教授We Klaus Schmitz博士做了關於P三C抑制劑作用機制的報告。

These definitive data result from our multi year partnership with Lu MC and the Dutch government to perform pioneering research on the P three C mechanism of action.

這些明確的數據源自於我們與 Lu MC 和荷蘭政府的多年合作，對 P 3 C 作用機制進行開創性研究。

Doctor Smids emphasized that his findings with I Beza PSTAT regarding the structural biology of DNA pile three C inhibitors have important implications for the development of a new family of antibiotics to treat high priority multidrug resistant gram positive infections. And that this novel class of DNA pile three C inhibitors could be an important new tool to address the pandemic of antimicrobial resistance.

Smids 博士強調，他與 I Beza PSTAT 有關 DNA 堆三 C 抑制劑結構生物學的發現對於開發治療高優先級多重抗藥性革蘭氏陽性感染的新抗生素家族具有重要意義。這種新型 DNA 堆三 C 抑制劑可能成為解決抗菌素抗藥性大流行的重要新工具。

Also in the quarter, we announced that selected AC X 375 DN AP three C analogs demonstrated in vitro activity against anthrax which is a bioterrorism category a pathogen including activity against ciprofloxacin resistant anthrax.

同樣在本季度，我們宣布選定的 AC X 375 DN AP 三個 C 類似物表現出針對炭疽的體外活性，炭疽是一種生物恐怖主義類別的病原體，包括針對耐環丙沙星炭疽的活性。

This work was performed at two independent qualified laboratories including the University of Florida. Planning is underway for an anthrax bioterrorism development program in October. We participated at ID week in Los Angeles, the annual Scientific Conference of the Infectious Disease Society of America Doctors, Kevin Gary and Tarn Eubank presented a scientific poster showing that in the phase two B clinical trial I ASOP post that had comparable clinical cure and sustained cure rates and safety profile to Vancomycin. The standard of care. Also five of five I belos that patients who were followed for a full three months after the end of treatment experienced no recurrence as opposed to treated patients showed decreased concentrations of fecal primary bile acids and higher ratios of secondary to primary bile acids than Vancomycin treated patients.

這項工作是在包括佛羅裡達大學在內的兩個獨立的合格實驗室進行的。十月份的炭疽生物恐怖主義發展計畫正在規劃中。我們參加了在洛杉磯舉行的ID week，即美國傳染病學會醫生年度科學會議，Kevin Gary 和Tarn Eubank 展示了一張科學海報，顯示在二期B 期臨床試驗I ASOP 帖子中，具有可比的臨床治愈率並持續萬古黴素的治癒率和安全性。護理標準。此外，與接受治療的患者相比，在治療結束後追蹤整三個月的五名患者中，有五名沒有出現復發，與萬古黴素治療的患者相比，糞便初級膽汁酸濃度降低，次級膽汁酸與初級膽汁酸的比例較高。

According to Dr Gary, these exciting results demonstrate two properties of a Bez aals that which may contribute to its anti recurrence effect. First, the preservation and restoration and restoration of beneficial bacterial classes in the gut provide resistance to recolonized to recolonization by seed of a seal.

Gary 博士表示，這些令人興奮的結果證明了 Bez aals 的兩個特性，這可能有助於其抗復發作用。首先，腸道中有益細菌類別的保存和恢復提供了對海豹種子重新定植的抵抗力。

Second, these data presented for the first time indicate that these beneficial bacteria known to metabolize primary to secondary bile acids persist and I belos that treated patients providing another important mechanism to prevent recurrent CDI.

其次，這些首次提供的數據表明，這些已知將初級膽汁酸代謝為次級膽汁酸的有益細菌持續存在，並且我認為治療的患者提供了另一種預防 CDI 復發的重要機制。

So now we have even more momentum going into the fourth quarter as we've continually reported as opposed to that clinical results continue to outperform in a serious and potentially life threatening infectious disease called C of ale bacteria that the US CDC categorizes as an urgent threat and calls for new classes of antibiotics for initial treatment that also have a low incidence of recurrence.

因此，現在我們進入第四季度的勢頭更加強勁，因為我們不斷報告臨床結果繼續優於一種嚴重且可能危及生命的傳染病，即啤酒桿菌，美國疾病管制與預防中心將其歸類為緊急威脅並呼籲使用新型抗生素進行初始治療，且復發率也較低。

I bet puls that also has FDA QIDP and fast track designation for the treatment of CDI.

我打賭 puls 也獲得了 FDA QIDP 和治療 CDI 的快速通道指定。

Additionally, we believe that I beza puls that if approved could make a favorable economic impact by reducing the overall annual us cost burden for cicle infection of approximately $5 billion per year. Of which 2.8 billion is due to recurrent CD I infection.

此外，我們相信，如果獲得批准，可以透過減少美國每年約 50 億美元的環線感染總體成本負擔來產生有利的經濟影響。其中28億是由於復發性CD I感染造成的。

Given our continuing momentum, we do believe the best is yet to come and now back to our CFO Rob Shaer to guide you through the highlights of our financial results for the third quarter, Rob.

鑑於我們持續的發展勢頭，我們確實相信最好的時刻尚未到來，現在請我們的首席財務官 Rob Shaer 來指導您了解我們第三季度財務業績的亮點，Rob。

Thanks Dave.

謝謝戴夫。

Our financial results for the third quarter ended September 30th were included in our press release issued earlier this morning.

我們截至 9 月 30 日的第三季財務業績已包含在今天早上早些時候發布的新聞稿中。

The company ended the quarter with cash totaling $5.8 million compared to $7.5 million. As of December 31 2023.

該公司本季末現金總額為 580 萬美元，去年同期為 750 萬美元。截至 2023 年 12 月 31 日。

During the third quarter, the company raised additional proceeds under its ATM financing program with gross proceeds of approximately $1.6 million.

第三季度，該公司透過 ATM 融資計劃籌集了額外資金，總收益約為 160 萬美元。

Research and development expenses for the three months ended September 30th 2024 or $1.2 million compared to 1.3 million for the three months ended September 30th,2023.

截至2024年9月30日止三個月的研發費用為120萬美元，截至2023年9月30日止三個月的研發費用為130萬美元。

The decrease was due primarily to an increase in manufacturing related costs of $0.1 million offset by a reduction in consulting fees of $0.2 million for the nine months ended September 30th research and development expenses were $4.6 million compared to $4.1 million for the nine months ended September 30th,2023 an increase of $0.5 million primarily due $2.9 million increase in manufacturing related costs offset by a $0.4 million decrease in consulting fees, general and administrative expenses for the three months ended September 30th 2024 or $1.6 million compared to $1.8 million for the three months ended September 30th,2023 a decrease of $0.2 million.

減少的主要原因是製造相關成本增加了10 萬美元，但被截至9 月30 日的九個月諮詢費減少20 萬美元所抵消；研發費用為460 萬美元，而截至9 月30 日的九個月為410 萬美元。 ，即160 萬美元，而截至2024 年9 月30 日止三個月為180 萬美元。

The decrease was due primarily to a $0.5 million decrease in non cash share based compensation offset by a $0.2 million increase in professional fees and a $0.1 million increase in compensation related costs for the nine months ended September 30th2024. General administrative expenses were $6.7 million compared to $5.4 million for the nine months ended September 30th2023 an increase of $1.3 million.

減少的主要原因是截至 2024 年 9 月 30 日的九個月中，非現金股份薪酬減少了 50 萬美元，但被專業費用增加了 20 萬美元以及薪酬相關成本增加了 10 萬美元所抵消。一般管理費用為 670 萬美元，較截至 2023 年 9 月 30 日止九個月的 540 萬美元增加了 130 萬美元。

The increase was primarily due to one point million, $1.1 million increase in professional fees and a $0.2 million increase in legal costs.

增加的主要原因是專業費用增加了 100 萬美元，法律費用增加了 20 萬美元。

The company reported a net loss of $2.8 million or 17¢ per diluted share for the three months ended September 30th 2024 compared to a net loss of $3.1 million or 24¢ per diluted share for the three months ended September 30th 2023 and a net loss of $11.3 million or 71¢ per share for the nine months ended September 30th 2024.

該公司報告，截至2024 年9 月30 日止三個月的淨虧損為280 萬美元，即每股稀釋每股17 美分，而截至2023 年9 月30 日止三個月，淨虧損為310萬美元，即每股稀釋每股24 美分，淨虧損為截至 2024 年 9 月 30 日的九個月，每股收益為 1,130 萬美元或 71 美分。

Compared to a net loss of $9.5 million or 77¢ per share for the nine months ended, September 30th 2023.

相較之下，截至 2023 年 9 月 30 日的九個月淨虧損為 950 萬美元，即每股虧損 77 美分。

All the reasons previously mentioned, the company had 16,770,378 shares outstanding as of September 30th 2024.

由於上述原因，截至 2024 年 9 月 30 日，該公司已發行股票為 16,770,378 股。

With that, I'll turn the call back over to Dave.

這樣，我會將電話轉回給戴夫。

Thanks Rob and thanks to all of you for joining us today. I'll now turn the call over to the operator to open up the call for questions, operator.

感謝羅布，也感謝大家今天加入我們。我現在將把電話轉給接線員，以打開提問電話，接線員。

Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two. If you would like to remove your question from the queue for participants using speaker equipment. It may be necessary to pick up your handset before pressing the star keys.

謝謝。我們現在將進行問答環節。如果您想提問，請按電話鍵盤上的星號一。確認音將表示您的線路已在問題佇列中。您可以按星二號。如果您想從使用揚聲器裝置的參與者群組中刪除您的問題。按星號鍵之前可能需要拿起聽筒。

One moment, please. While we pull for questions.

請稍等一下。當我們提出問題時。

The first question is from Head RC from HC Wainwright. Please go ahead.

第一個問題來自 HC Wainwright 的 Head RC。請繼續。

Hi, good morning, everyone. This is Thomas asking a couple of questions for Ed. Thank you for picking up questions. So, so first question. Hi, good morning. Perhaps. Well, first, can you discuss more about the predicted model that you discussed earlier on the call? You know, as a potential dynamic tool?

嗨，大家早安。這是湯瑪斯向艾德問了幾個問題。感謝您提出問題。那麼，第一個問題。嗨，早安。也許。好吧，首先，您能否詳細討論您之前在電話會議中討論的預測模型？你知道，作為一種潛在的動態工具嗎？

Yeah, so that, that's one of the one of the items that we filed a patent for in the quarter. Basically, there are certain measurements, you know, kind of proprietary, but there's certain measurements of the the stool samples that there that the doc Doctor Gary and, and our medical director Mike Silverman, were able to focus in on and see by the end of the third day of treatment.

是的，所以這是我們在本季申請專利的項目之一。基本上，有一些特定的測量結果，你知道，有點專有，但是加里醫生和我們的醫療總監邁克西爾弗曼能夠集中精力並在最後看到對糞便樣本的某些測量結果治療第三天。

If certain measurements were as, you know, as they found they would consistently be the same for the rest of the 10 day treatment period.

如果某些測量結果如他們所發現的那樣，那麼在 10 天治療期的剩餘時間內它們將始終保持相同。

And those measurements seem to be predictive as to whether a patient will reinfect.

這些測量結果似乎可以預測患者是否會再次感染。

So basically, if they find certain ratios of different things in the stool samples, they can predict, they believe, certainly they need a lot more patients to prove it out. But they think they can predict by the end of three days of treatment if any antibiotic is going to be a high risk of reinfection.

所以基本上，如果他們在糞便樣本中發現不同物質的一定比例，他們就可以預測，他們相信，當然他們需要更多的患者來證明這一點。但他們認為，他們可以在三天治療結束時預測是否有任何抗生素會帶來再次感染的高風險。

So we're going to continue to monitor that in phase three. But that by itself could be a diagnostic that could be quite useful to reduce the $2.8 billion per year cost burden for recurrent seed of a seal infection. Because treating physicians could use this test kit as a way to swap out one treatment or one therapeutic for another to try to increase the likelihood that a patient will successfully remain uninfected.

因此，我們將在第三階段繼續監控這種情況。但這本身就可能是一種診斷，對於減少海豹反覆感染種子每年 28 億美元的成本負擔非常有用。因為治療醫生可以使用該測試套件作為一種方法來替換一種治療或一種治療為另一種治療，以嘗試增加患者成功保持不感染的可能性。

Very good.

非常好。

That sounds interesting. Yeah, that's definitely I'm very interested to learn more about this in the near future. And then perhaps another question related to the press oasi you, you mentioned that in the international Regularatory filing initiatives are ongoing this quarter. Can you discuss more details about these initiatives?

聽起來很有趣。是的，我確實非常有興趣在不久的將來了解更多相關資訊。然後也許是與媒體綠洲有關的另一個問題，您提到本季正在進行國際監管備案措施。您能否討論更多有關這些舉措的細節？

Oh, sure. So we're starting in in Europe with the European Medicines Agency and that process will probably lead to a meeting either the tail end of the year or more likely a first quarter of next year. And that would be a meeting with the European Medicines Agency to just set the regulatory pathway to approval on the basis of doing international phase three trials including in Europe.

哦，當然。因此，我們將在歐洲與歐洲藥品管理局合作，這個過程可能會在今年年底或更可能在明年第一季舉行會議。這將是與歐洲藥品管理局的會議，以在包括歐洲在內的國際三期試驗的基礎上製定批准的監管途徑。

And you know, we what some may ask, why haven't we set up that meeting sooner. And the answer to that is we needed the results from the FDA clinical and manufacturing regulatory processes to be completed in order to go to the EMEA with or E MA as it's now called with a final package.

你知道，有些人可能會問，我們為什麼不早點召開會議。答案是我們需要完成 FDA 臨床和製造監管流程的結果，以便將最終包發送到 EMEA 或 E MA（現在稱為最終包）。

That's that FDA cleared after the after Europe, we'll proceed with the UK, Canada and eventually Japan.

FDA 在歐洲之後批准了這項計劃，我們將繼續在英國、加拿大，最終在日本進行批准。

Understood. And then, and then I, I suppose as as as you mentioned, we're close to wrapping up the phase three program in the US. Can you like, what are some top options that you, that you will likely to be able to fund the trials? You know, and which one would you prefer?

明白了。然後，我想正如您所提到的，我們即將完成美國的第三階段計劃。您可以介紹一下您可能能夠資助試驗的一些最佳選擇嗎？你知道嗎，你比較喜歡哪一個？

Well, we, in all cases, we prefer anything that's non dilutive as I, I'm sure you understand. But we like partnering options and I use the word partnering broadly to include the government along with territorial license and co development partners, which we have active dialogue going with several companies now in Europe and Japan and South America.

好吧，在所有情況下，我們都像我一樣更喜歡任何非稀釋性的東西，我相信你明白。但我們喜歡合作選擇，我廣泛使用「合作」這個詞，包括政府以及領土許可和共同開發合作夥伴，我們現在與歐洲、日本和南美洲的幾家公司進行積極對話。

With the government, we did have a tech watch meeting back in October and we've had a lot of follow up from that meeting there. I think there were about 50 government officials from, you know, different agencies of the government that could fund phase three and also could fund AC X 375 the second program which has now has the new hook with the, with the anthrax.

早在 10 月份，我們就與政府一起召開了一次技術觀察會議，並且在那次會議上我們進行了許多後續行動。我認為大約有 50 名來自政府不同機構的政府官員可以為第三階段提供資金，也可以為第二個項目 AC X 375 提供資金，該項目現在與炭疽有新的掛鉤。

So the non diluted sources of funding obviously are better for our shareholders. And don't forget the Paste Act is still out there and I, you know, understand that it's much more prominently possible to be passed in the near future. More than it's been in any of our prior calls.

因此，非稀釋的資金來源顯然對我們的股東來說更好。不要忘記《貼上法案》仍然存在，我知道，它在不久的將來更有可能獲得通過。比我們之前的任何電話會議都要多。

Understood. Thank you. Thank you so much for the kind of questions again and looking forward to progress in, in the US and in Europe as well.

明白了。謝謝。非常感謝您再次提出此類問題，並期待在美國和歐洲取得進展。

Thank you so much, Thomas.

非常感謝你，托馬斯。

The next question is from Laura Molloy from alliance resource partners. Please go ahead.

下一個問題來自聯盟資源合作夥伴的 Laura Molloy。請繼續。

Hello, this is Laura on for gym life. Thank you for taking the questions.

大家好，我是蘿拉，參加健身生活。感謝您提出問題。

I'm sorry, was it Laura ?

抱歉，是勞拉嗎？

Yes, Laura. Oh.

是的，勞拉。哦。

Good morning.

早安.

Good morning. So for the upcoming phase three program, maybe we just have a bit more insight on the earliest potential start for this for the first phase three trial as well as any proposed study designs or data readout time lines that you have here for both of the phase three trials.

早安.因此，對於即將到來的第三階段計劃，也許我們只是對第一個第三階段試驗的最早可能開始時間以及您在這裡為兩個階段提供的任何擬議的研究設計或數據讀出時間線有更多的了解三個試驗。

So it's a little bit up in the air as we continue to source the resource that we need to fund the phase three trials. But the trial design is two phase three registration trials international at about 100 and 50 trial sites, 450 patients per trial for a total of 900 patients and both trials are the same 1 to 1 randomized against oral vancomycin for a 10 day treatment period. The, the primary and secondary endpoints are identical to the phase two B clinical trial end points that we worked with for phase two B.

因此，當我們繼續尋找資助第三階段試驗所需的資源時，這有點懸而未決。但試驗設計是國際上約100和50個試驗地點的兩個三期註冊試驗，每個試驗450名患者，總共900名患者，這兩項試驗都是相同的1比1隨機對照口服萬古黴素，為期10天的治療期。主要和次要終點與我們為第二 B 期工作的第二 B 期臨床試驗終點相同。

So that's that's really about it. You know, we're in a great position in that we can do the phase three program sequentially or, and, or instead of doing both trials at the same time, we have that kind of flexibility because we have 10 years of regulatory exclusivity from the time we get FDA approval. And there's similar advantages available in Europe. I think it's nine years in Europe. So really, we're not confined by the commercialization need of having, you know, patents that expire.

這就是真正的意義。你知道，我們處於有利地位，因為我們可以按順序進行第三階段計劃，或者，或者，或者而不是同時進行兩項試驗，我們擁有這種靈活性，因為我們擁有 10 年的監管排他性當我們獲得FDA 批准時。歐洲也有類似的優勢。我想在歐洲已經九年了。所以實際上，我們並不受商業化需求的限制，因為擁有過期的專利。

So we really just need to raise the money for one phase three.

所以我們真的只需要為第三階段募款。

And then as the plan would go, if we can raise the money for one of the phase three and the date is good as we expect, then we can raise the money at a higher price for the second phase three.

然後按照計劃，如果我們能夠為第三階段之一籌集資金，並且日期如我們預期的那樣好，那麼我們可以以更高的價格為第二階段三階段籌集資金。

Got it. And then also for your AC X 375 candidate, you mentioned the research conducted in anthrax at the University of Florida. So where are you currently in the development of the anthrax bioterrorism program that you mentioned? And then also what are some potential partnership opportunities currently looking like for this program specifically.

知道了。然後，對於您的 AC X 375 候選人，您提到了佛羅裡達大學針對炭疽病進行的研究。那麼，您提到的炭疽生物恐怖主義計畫目前進展到什麼程度呢？然後，目前該計劃的一些潛在合作機會是什麼？

Well, this program is pre clinical, so we don't want to get over our skis on it. We, we have some laboratory studies that we have to do some animal studies that we have to do to kind of dress it up right now. You know, we have this independent research M IC studies and a couple of independent labs. The data is really good and obviously anthrax gets stockpiled by governments around the world because of bioterrorism. So there's not a lot of anthrax patients out there. But you know, so it, it wouldn't be the kind of thing that we would, you know, find a commercial partner to partner with and go out and sell anthrax somewhere. It would be kind of like a if somebody bought it, they would be buying it to try to get government contracts around the world for stockpiling.

嗯，這個計畫是臨床前的，所以我們不想在它上面放棄我們的滑雪板。我們，我們有一些實驗室研究，我們必須做一些動物研究，我們現在必須做一些修飾它。你知道，我們有獨立的 MIC 研究和幾個獨立的實驗室。這些數據確實很好，顯然，由於生物恐怖主義，世界各國政府都儲存了炭疽病。所以那裡的炭疽病患者並不多。但你知道，所以，這不會是我們會找到商業夥伴合作並出去在某個地方銷售炭疽病的事情。這有點像如果有人購買它，他們會購買它以試圖獲得世界各地的政府合約來儲存。

But that would, that this has just been discovered a couple of months ago. So we're just in the beginning phases.

但這是幾個月前才發現的。所以我們還處於開始階段。

Understood and then just one more question from us. So you also mentioned the recent presentation done on the Preclinical GPS program specifically in targeting mea.

明白了，然後我們再問一個問題。因此，您也提到了最近針對臨床前 GPS 計劃進行的演示，特別是針對 MEA。

So what are other future clinical development plans that you have for this program as well?

那麼，你們對於這個計畫還有哪些未來的臨床開發計畫呢？

Well, it will start with the Mersa infections and that'll, it'll go into VRE and DRSP infections, but epsis is probably the biggest incidence of Mersa infections. So we think that's the most attractive one for us to go after. So it's acute bacterial skin and skin structure infections that we start with. Those are ones caused by MSA. And then, then we'll get into other areas of Mersa infections and VRE and DRSP.

嗯，它將從 Mersa 感染開始，然後，它將進入 VRE 和 DRSP 感染，但敗血症可能是 Mersa 感染的最大發生率。所以我們認為這是對我們來說最有吸引力的目標。因此，我們首先從急性細菌性皮膚和皮膚結構感染開始。這些是由 MSA 引起的。然後，我們將討論 Mersa 感染以及 VRE 和 DRSP 的其他領域。

Got it. Thank you for taking the questions.

知道了。感謝您提出問題。

The next question is from John Stinson, a private investor. Please go ahead.

下一個問題來自私人投資者約翰·斯廷森。請繼續。

Good morning David. Thank you for taking our questions. Good morning John.

早安，大衛。感謝您接受我們的提問。早安，約翰。

I'm kind of surprised that we haven't heard from a big partner, Big Pharma partner by now. Did you say you're, you're trying to hold off on that because of the amount of dilution that they're demanding? Can you talk a little more about that possibility of a partnership in, in the near future?

我有點驚訝的是，我們現在還沒有收到大型合作夥伴、大型製藥合作夥伴的消息。你是否說過，由於他們要求的稀釋程度，你正試圖推遲這項計畫？您能多談談在不久的將來建立合作關係的可能性嗎？

Sure, John. Oh, well, you know, it reminds me of my first biotech company, you know, we signed up a bank, I think it was credit suisse. And it took three or four years by the time we got a deal done and, you know, these things are sometimes very time consuming. Things don't happen overnight and, you know, I don't know if you've had experience in Japan. But just as an example, japanese companies move very slowly, they, you know, they watch, they learn, they look the diligence and you know, you keep going until you find deal terms that your board likes that. They think it reflects the right value.

當然，約翰。哦，好吧，你知道，這讓我想起了我的第一家生物技術公司，你知道，我們簽了一家銀行，我認為是瑞士信貸。我們花了三、四年才達成交易，你知道，這些事情有時非常耗時。事情不會在一夜之間發生，你知道，我不知道你是否有在日本的經驗。但舉個例子，日本公司的行動非常緩慢，他們，你知道，他們觀察，他們學習，他們看起來很勤奮，你知道，你會繼續前進，直到找到董事會喜歡的交易條款。他們認為這反映了正確的價值觀。

So we have a different parties looking at M&A different parties looking at territorial deals.

因此，我們有不同的各方在考慮併購，不同的各方在考慮領土交易。

And we have the government, which is obviously the ultimate nondilutive partner, but we're not slowing any partnerships down, partnerships with private companies won't dilute our shareholders at all.

我們有政府，這顯然是最終的非稀釋合作夥伴，但我們不會放慢任何合作夥伴關係，與私人公司的合作夥伴關係根本不會稀釋我們的股東。

You know, what we would do is, you know, in our financial modeling, if we were to say, do a Japanese Territorial License and Co Development Agreement, Our financial modeling and Wall Street's financial modeling on our company would become one based on upfront payments, clinical and commercial milestones and royalties as opposed to, you know, straight up operational advancements, R&D costs followed by commercialization revenues in the territory. So it would, it wouldn't be a dilutive thing to have a private license of codevelopment agreement in Japan or Europe or South America. It would be a positive thing for us and it would raise us the money that we would need to, you know, kind of move to phase three.

你知道，我們會做的是，你知道，在我們的財務模型中，如果我們說，簽訂一份日本領土許可和共同開發協議，我們的財務模型和華爾街對我們公司的財務模型將成為基於前期的模型付款、臨床和商業里程碑以及特許權使用費，而不是直接的營運進步、研發成本以及該地區的商業化收入。因此，在日本、歐洲或南美洲擁有共同開發協議的私人許可不會是稀釋事。這對我們來說是一件積極的事情，它會為我們籌集到進入第三階段所需的資金。

So what we look at generally speaking, because we need to raise so much money for phase three, we're taking a multi step approach and we're basically, you know, using all the levers that we have available to us to raise the money that we need as non dely as possible.

所以我們一般來說，因為我們需要為第三階段籌集這麼多資金，所以我們正在採取多步驟方法，我們基本上，你知道，利用我們可用的所有槓桿來籌集資金盡可能不延遲我們需要的錢。

So that's, that's kind of in a nutshell. That's what we're doing.

簡而言之。這就是我們正在做的事情。

All right. Thank you, David.

好的。謝謝你，大衛。

No problem. Thank you John. For asking the question.

沒問題。謝謝約翰。為了問這個問題。

This concludes the question and answer session and today's teleconference, you may disconnect your lines at this time. Thank you for your participation.

今天的問答環節和電話會議到此結束，您可以掛斷電話了。感謝您的參與。

Thank you, Operator.

謝謝你，接線生。