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Operator
Operator
Good morning, and welcome to the SCYNEXIS Third Quarter 2022 Earnings Conference Call. (Operator Instructions) Please note, this event is being recorded.
早上好,歡迎來到 SCYNEXIS 2022 年第三季度收益電話會議。 (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 Debbie Etchison, Executive Director, Communications and Investor Relations.
我現在想把會議轉交給傳播和投資者關係執行董事 Debbie Etchison。
Debbie Etchison - Executive Director of Communications
Debbie Etchison - Executive Director of Communications
Hello, everyone, and welcome to today's conference call to discuss our third quarter 2022 financial results and corporate update. Before we start, let me remind you that today's call will include forward-looking statements based on current expectations, including statements concerning our financial outlook for the future, leadership's expectations for our future financial and operational performance, as well as our business strategy because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements.
大家好,歡迎參加今天的電話會議,討論我們 2022 年第三季度的財務業績和公司更新。在我們開始之前,讓我提醒您,今天的電話會議將包括基於當前預期的前瞻性陳述,包括關於我們未來財務前景的陳述、領導層對我們未來財務和運營業績的預期,以及我們的業務戰略,因為這樣陳述受風險和不確定性的影響,實際結果可能與此類前瞻性陳述明示或暗示的結果存在重大差異。
Please refer to our filings with the Securities and Exchange Commission, including our most recent annual report on Form 10-K and quarterly report on Form 10-Q, including in each case under the caption Risk Factors and another documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements speak only as of today, November 9th, 2022. SCYNEXIS undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
請參閱我們向美國證券交易委員會提交的文件,包括我們最近的 10-K 表格年度報告和 10-Q 表格季度報告,包括在每種情況下的風險因素標題下以及隨後提交或提供的其他文件證券交易委員會。所有前瞻性陳述僅適用於今天,即 2022 年 11 月 9 日。SCYNEXIS 不承擔更新此類陳述的義務,以反映在作出陳述之日之後發生的事件或存在的情況。
The information on today's call is not intended for promotional purposes and not sufficient for prescribing decisions.
今天電話會議上的信息並非用於促銷目的,也不足以做出處方決定。
Joining us on today's call are SCYNEXIS' President and CEO, Marco Taglietti; Chief Medical Officer, Dr.David Angulo; and Chief Financial Officer, Ivor Macleod. Following our prepared remarks, we'll open the call to your questions.
參加今天電話會議的還有 SCYNEXIS 總裁兼首席執行官 Marco Taglietti;首席醫療官 David Angulo 博士;和首席財務官 Ivor Macleod。在我們準備好的評論之後,我們將開始回答您的問題。
Now, I will turn the call over to Dr. Marco Taglietti, President and CEO.
現在,我將把電話轉給總裁兼首席執行官 Marco Taglietti 博士。
Marco Taglietti - CEO, President & Director
Marco Taglietti - CEO, President & Director
Thank you, Debbie. Good morning, everyone. Bonjour (inaudible). Thank you for joining us today for our third quarter 2022 earnings investor call. I want to begin by drawing your attention to a recent report issued by the World Health Organization or WHO. This was the first ever list of priority deadly fungal pathogens that are becoming a growing, global public health manage.
謝謝你,黛比。大家,早安。 Bonjour(聽不清)。感謝您今天加入我們的 2022 年第三季度收益投資者電話會議。首先,我想提請您注意世界衛生組織或世衛組織最近發布的一份報告。這是有史以來第一份優先致命真菌病原體清單,這些病原體正在成為日益增長的全球公共衛生管理。
The list includes well-known vicious pathogens such as Candida auris, another Candida species, albicans, glabrata, parapsilosis, tropicalis and molds like Aspergillus fumigatus, histoplasma, Mucorales, all pathogens against, which Ibrexafungerp shows great activity, even in strains highly resistant to other antifungals. And the data from our Phase 3 studies FURI and CARES provides clinical hard evidence of the activity of Ibrexafungerp against severe, difficult-to-treat fungal infection even when they are refractory to currently available treatments.
該列表包括眾所周知的惡性病原體,例如 Candida auris、另一種念珠菌、白色念珠菌、光滑念珠菌、近平滑念珠菌、熱帶念珠菌和黴菌,例如煙曲霉、組織胞漿菌、毛黴目,所有針對這些病原體的 Ibrexafunerp 都表現出很強的活性,即使是對這些念珠菌具有高度抗性的菌株其他抗真菌藥。來自我們 3 期研究 FURI 和 CARES 的數據提供了 Ibrexafungerp 對嚴重、難以治療的真菌感染的活性的臨床確鑿證據,即使它們對目前可用的治療方法無效。
Moreover, these WHO's call for action is further validating our corporate strategy to refocus on life-threatening invasive fungal infections, while monetizing BREXAFEMME in vulvovaginal candidiasis. So we at SCYNEXIS are proud to be on the front lines with Ibrexafungerp to fight this never-ending warfare against antimicrobial resistant pathogens. We are prepared and we are ready. David will provide more details on our continuing efforts to stay in front of this steadily fungal pathogens.
此外,世衛組織的這些行動呼籲進一步驗證了我們的企業戰略,即重新關注威脅生命的侵襲性真菌感染,同時將 BREXAFEMME 用於外陰陰道念珠菌病。因此,我們 SCYNEXIS 很自豪能與 Ibrexafungerp 一起站在前線,與這場永無止境的抗微生物病原體戰爭作鬥爭。我們準備好了,我們準備好了。大衛將提供更多詳細信息,說明我們為抵禦這種穩定的真菌病原體所做的持續努力。
As we have recently announced, SCYNEXIS is transforming the company by refocusing our resources to the clinical development of the oral and intravenous liposomal formulation of ibrexafungerp for severe hospital-based indications, where higher long-term returns are expected. [This is] the right strategy at this time because of the growing threat of serious and potentially deadly fungal infections that I just mentioned, where we believe ibrexafungerp can play a significant role saving lives, while achieving its full market potential. At the same time, we are actively pursuing suitable commercialization partners for BREXAFEMME in the U.S. for vulvovaginal candidiasis and for ibrexafungerp outside of the U.S. And we are making good progress on this front. Stay tuned.
正如我們最近宣布的那樣,SCYNEXIS 正在通過將我們的資源重新集中到 ibrexafunerp 的口服和靜脈脂質體製劑的臨床開發來實現公司轉型,以應對嚴重的醫院適應症,預計長期回報更高。 [這是]目前正確的策略,因為我剛才提到的嚴重和潛在致命真菌感染的威脅越來越大,我們相信 ibrexafungerp 可以在拯救生命方面發揮重要作用,同時發揮其全部市場潛力。與此同時,我們正在美國積極尋找適合外陰陰道念珠菌病的 BREXAFEMME 和美國以外的 ibrexafungerp 的合適商業化合作夥伴,我們在這方面取得了良好進展。敬請關注。
Well, we are in the process of out-licensing BREXAFEMME in the U.S. for VVC, we will continue to keep this important product on the market in the U.S. and to make it available for the many patients, who can benefit from its proven efficacy. We will minimize the resources allocated to the active promotion of BREXAFEMME in order to redirect our cash to the development of more [origin] hospital indications.
好吧,我們正在美國將 BREXAFEMME 授權給 VVC,我們將繼續在美國市場上保留這一重要產品,並使其可供許多患者使用,他們可以從其已證實的療效中受益。我們將盡量減少分配給 BREXAFEMME 積極推廣的資源,以便將我們的現金重新用於開發更多[來源]醫院適應症。
Our supplemental NDA filing for recurrent VVC is on track with a PDUFA decision date of November 30th, 2022. If approved for the second indication, BREXAFEMME will be the first and only therapy approved in the U.S. for both the treatment of VVC and the prevention of recurrent VVC. We believe that this anticipated second indication is extremely attractive to a commercialization partner and will help expand patients access to our innovative treatment.
我們針對複發性 VVC 的補充 NDA 申請正在按計劃進行,PDUFA 決定日期為 2022 年 11 月 30 日。如果批准用於第二個適應症,BREXAFEMME 將成為美國批准的第一個也是唯一一個治療 VVC 和預防 VVC 的療法復發性 VVC。我們相信,這個預期的第二個適應症對商業化合作夥伴極具吸引力,並將有助於擴大患者獲得我們創新治療的機會。
On the corporate side, we closed the third quarter 2022 with more than $96 million in cash. And with our new restructuring plan, we have extended our cash runway into the second quarter of 2024. This cash is expected to support our hospital programs to enable additional regulatory filings in 2024. Ivor Macleod, our new CFO, will provide more details on our expenses and cash balance; and then we will open the floor for a Q&A session.
在企業方面,我們以超過 9600 萬美元的現金結束了 2022 年第三季度。通過我們新的重組計劃,我們已將現金跑道延長至 2024 年第二季度。預計這筆現金將支持我們的醫院計劃,以便在 2024 年進行更多的監管備案。我們的新任首席財務官 Ivor Macleod 將提供有關我們的更多詳細信息費用和現金餘額;然後我們將開始進行問答環節。
Now, let me turn BREXAFEMME -- to BREXAFEMME performance in vaginalis infections for this quarter. We continue to increase the number of BREXAFEMME prescribers. In Q3, almost 2,500 HCPs prescribed BREXAFEMME, representing an increase of 11% quarter-over-quarter and even a -- an higher increase over 30% of repeat prescribers, showing that when HCPs use BREXAFEMME for their patients, they are willing to prescribe it again.
現在,讓我將 BREXAFEMME——轉向 BREXAFEMME 本季度在陰道感染方面的表現。我們繼續增加 BREXAFEMME 處方者的數量。在第三季度,近 2,500 名 HCP 開了 BREXAFEMME,比上一季度增加了 11%,甚至比重複開處方的人增加了 30%,這表明當 HCP 為他們的患者使用 BREXAFEMME 時,他們願意開處方再次。
BREXAFEMME prescriptions continued to grow in the third quarter. We generated almost 5,800 prescription in the third quarter of 2022, representing 30% growth over the second quarter of 2022, continuing a trend of growth. However, we do expect some disruption to this trend in the fourth quarter, as a result of our decision to end the in-person promotion with [Amplity Health].
BREXAFEMME 處方藥在第三季度繼續增長。我們在 2022 年第三季度產生了近 5,800 張處方,比 2022 年第二季度增長了 30%,繼續保持增長趨勢。然而,由於我們決定結束與 [Amplity Health] 的面對面促銷,我們確實預計第四季度這一趨勢會受到一些干擾。
After signing our contract with a major national pharmacy benefit manager, PBM, in October, we successfully garnered BREXAFEMME coverage of 130 million commercially insured lives, representing 70% of the commercial universe.
在 10 月與一家主要的國家藥房福利管理公司 PBM 簽訂合同後,我們成功地獲得了 BREXAFEMME 對 1.3 億商業保險生命的覆蓋,佔商業領域的 70%。
I will now turn the call over to Dr. David Angulo, our Chief Medical Officer; and future Chief Executive Officer. David?
我現在將把電話轉給我們的首席醫療官 David Angulo 博士;和未來的首席執行官。大衛?
David Gonzalez Angulo - Chief Medical Officer
David Gonzalez Angulo - Chief Medical Officer
Thank you, Marco. Before I get towards the pipeline update, I would like to share with you a page out of the WHO report on the first ever list of priority fungal pathogens that Marco mentioned earlier. The intention of this report is to drive both research efforts and policy interventions to increase the global response to the fungi that represent the greatest threat to public health, as they become increasingly common and resistant to treatment.
謝謝你,馬可。在我開始管道更新之前,我想與您分享 WHO 報告中的一頁,該報告是 Marco 之前提到的第一份重點真菌病原體清單。本報告的目的是推動研究工作和政策干預,以加強全球對真菌的反應,這些真菌對公眾健康構成最大威脅,因為它們變得越來越普遍並且對治療產生耐藥性。
Ibrexafungerp has demonstrated activity against most of the pathogens in the critical, in high priority groups of this list, including Candida auris and all other clinically relevant Candida species mentioned here, albicans, glabrata, parapsilosis, tropicalis. It has also shown activity against Aspergillus fumigatos, histoplasma and Mucorales. Ibrexafungerp spectrum of activity is very well suited to address many of these critical needs and/or development programs [are] already evaluating ibrexafungerp in these areas.
Ibrexafunerp 已證明對大多數關鍵病原體具有活性,在該列表的高優先級組中,包括耳念珠菌和此處提到的所有其他臨床相關念珠菌物種、白色念珠菌、光滑念珠菌、近平滑念珠菌、熱帶念珠菌。它還顯示出對煙曲霉、組織胞漿菌和毛黴菌的活性。 Ibrexafungerp 的活性範圍非常適合解決許多這些關鍵需求和/或開發計劃 [正在] 已經在這些領域評估 ibrexafungerp。
As you recall, the FURI study includes patients with infections caused by many of these pathogens that are not adequately treated with current treatment options. The CARES study focused on Candida auris. The SCYNERGIA study in Aspergillus. And the MARIO study in [candid] infections by all clinical relevant species. It has been very encouraging to see that WHO underscoring the need to further development on these areas and how well our development plan fits within their critical and high priority list.
正如您所記得的,FURI 研究包括由許多這些病原體引起的感染患者,這些病原體無法通過當前的治療方案得到充分治療。 CARES 研究的重點是耳念珠菌。曲霉菌中的 SCYNERGIA 研究。以及對所有臨床相關物種的 [坦率] 感染進行的 MARIO 研究。看到世衛組織強調進一步發展這些領域的必要性,以及我們的發展計劃如何符合他們的關鍵和高度優先事項清單,真是令人鼓舞。
We stand ready at the right place and in the right time with a significantly derisked antifungal asset that has already received its first FDA approval for one indication and a rapidly advancing development program addressing critical needs in the antifungal space, including difficult-to-treat and resistant fungal infections, with an anticipated first approval in the hospital setting by late 2024. We believe that our hospital program can unlock significant value to both our patients and our shareholders.
我們在正確的地點和正確的時間準備好了一項風險顯著降低的抗真菌資產,該資產已經獲得了 FDA 對一個適應症的首次批准,以及一項快速推進的開發計劃,以滿足抗真菌領域的關鍵需求,包括難以治療和耐藥真菌感染,預計到 2024 年底在醫院環境中首次獲得批准。我們相信,我們的醫院計劃可以為我們的患者和股東釋放巨大的價值。
We are advancing our pipeline quickly towards hospital utilization. We have already reached our target enrollment of 200 subjects in the FURI study and we'll soon begin study closure activities to enable completion of the follow-up of all the cases by first half of next year. This will be followed by the final data review, committee review and reporting of final data, as guided early in 2024.
我們正在迅速推進我們的管道以實現醫院利用。我們已經在 FURI 研究中達到了 200 名受試者的目標招募,我們將很快開始研究結束活動,以便在明年上半年完成所有病例的隨訪。隨後將按照 2024 年初的指導進行最終數據審查、委員會審查和最終數據報告。
The CARES study will follow a similar time line. As a reminder, the CARES and FURI study are evaluating ibrexafungerp in patients with Candida auris and other refractory fungal infections.
CARES 研究將遵循類似的時間表。提醒一下,CARES 和 FURI 研究正在評估 ibrexafungerp 在耳念珠菌和其他難治性真菌感染患者中的療效。
The SCYNERGIA study in aspergillosis is closing enrollment as well. We are planning to close out the study and analyze the available data in the first half of 2023. The data from this Phase 2 study even in a smaller number of subjects that anticipated will guide potential next steps in this development path.
曲霉病的 SCYNERGIA 研究也正在結束招募。我們計劃在 2023 年上半年結束研究並分析可用數據。即使是在預期的少數受試者中,這項 2 期研究的數據也將指導這一發展道路上潛在的後續步驟。
Enrollment is active in the MARIO study, which is evaluating ibrexafungerp in patients with invasive candidiasis. We aim to open approximately 70 sites globally. As previously guided, we are anticipating completion of the study by end of next year with data in early 2024.
MARIO 研究的招募很活躍,該研究正在評估 ibrexafungerp 在侵襲性念珠菌病患者中的療效。我們的目標是在全球開設大約 70 個站點。按照之前的指導,我們預計該研究將於明年年底完成,並在 2024 年初提供數據。
As mentioned previously, the data from the MARIO study, along with the data from FURI and CARES studies are intended to be supportive of an NDA submission in 2024 with an anticipated first approval for an indication in the hospital setting later that year.
如前所述,MARIO 研究的數據以及 FURI 和 CARES 研究的數據旨在支持 2024 年提交的 NDA,預計該年晚些時候首次批准在醫院環境中使用適應症。
We also plan to advance our IV formulation of ibrexafungerp into a Phase 2 trial in 2023, with results expected in 2024. The data from this study will inform the design of a Phase 3 study that is expected to enable us to make the intravenous formulation available in the market, broadening the clinical utility of ibrexafungerp, as a comprehensive antifungal solution to the current critical need.
我們還計劃在 2023 年將 ibrexafungerp 的 IV 製劑推進到 2 期試驗,預計在 2024 年取得結果。該研究的數據將為 3 期研究的設計提供信息,該研究有望使我們能夠提供靜脈製劑在市場上,擴大 ibrexafungerp 的臨床效用,作為滿足當前迫切需求的綜合抗真菌解決方案。
We are now weeks away from our November 30 PDUFA date for BREXAFEMME in recurrent VVC. And we remain on track and remain confident in the positive outcome for BREXAFEMME patients -- for BREXAFEMME and for patients. After this approval, we plan to communicate with prescribers regarding this new indication and key information in the updated level.
現在距離 11 月 30 日 PDUFA 日期為 BREXAFEMME 在經常性 VVC 中的日期還有幾週。我們保持正軌,並對 BREXAFEMME 患者的積極結果保持信心——對於 BREXAFEMME 和患者。在獲得批准後,我們計劃就這一新適應症和更新級別的關鍵信息與處方醫生進行溝通。
Thank you. And I will now turn the call over to Ivor Macleod, our Chief Financial Officer.
謝謝。我現在將把電話轉給我們的首席財務官 Ivor Macleod。
Ivor Macleod - CFO
Ivor Macleod - CFO
Thank you, David. Good morning, everyone, and thank you for joining today's call. I'm Ivor Macleod, and it is my pleasure to speak to you for the first time as the new CFO of SCYNEXIS.
謝謝你,大衛。大家早上好,感謝您參加今天的電話會議。我是 Ivor Macleod,很高興作為 SCYNEXIS 的新任首席財務官首次與您交談。
Before I get to the financials, I have to say that I'm delighted to join a company with such a talented management team, as well as strong scientific acumen focused on addressing the ever-increasing threats of infectious disease. I very much look forward to working with Marco, David and the team, both during this period of transition, as well as over the coming years contributing to the future success of ibrexafungerp.
在談到財務之前,我不得不說,我很高興加入一家擁有如此才華橫溢的管理團隊以及專注於應對日益增長的傳染病威脅的強大科學敏銳度的公司。我非常期待在這個過渡時期以及未來幾年與 Marco、David 和團隊合作,為 ibrexafungerp 的未來成功做出貢獻。
Let me now turn to the financials. BREXAFEMME net product revenues in the third quarter of 2022 increased approximately 23% to $1.6 million over the $1.3 million that we realized in the second quarter.
現在讓我談談財務狀況。 BREXAFEMME 2022 年第三季度的產品淨收入比我們在第二季度實現的 130 萬美元增長了約 23%,達到 160 萬美元。
Research and development expenses for the third quarter of 2022 were $6.4 million compared to $4.4 million for the comparable period in 2021. The $2 million increase was primarily a result of the increased clinical development expenses for the MARIO and VANQUISH studies, as well as preclinical expenses associated with our IV liposomal formulation.
2022 年第三季度的研發費用為 640 萬美元,而 2021 年同期為 440 萬美元。增加 200 萬美元的主要原因是 MARIO 和 VANQUISH 研究的臨床開發費用以及臨床前費用增加與我們的 IV 脂質體製劑相關。
Selling, general and administrative expenses for the third quarter of 2022 were $16.7 million versus $15.4 million in the third quarter of 2021. The $1.3 million increase or roughly 9% for the 3 months ended September 30th, 2022, were primarily driven by an increase in costs recognized to support the commercialization of BREXAFEMME.
2022 年第三季度的銷售、一般和管理費用為 1670 萬美元,而 2021 年第三季度為 1540 萬美元。截至 2022 年 9 月 30 日的三個月增加 130 萬美元或約 9%,主要是由於為支持 BREXAFEMME 的商業化而確認的成本。
Total other expense was $7.8 million for the third quarter of 2022 versus total other income of $18.8 million for the third quarter of 2021. During the third quarter of 2022 and the third quarter of 2021, SCYNEXIS recognized a non-cash loss of $6.5 million and a non-cash gain of $18.8 million, respectively, on the fair value adjustment of our warrant liabilities.
2022 年第三季度的其他總支出為 780 萬美元,而 2021 年第三季度的其他總收入為 1880 萬美元。在 2022 年第三季度和 2021 年第三季度, SCYNEXIS 確認了 650 萬美元的非現金損失和我們的認股權證負債的公允價值調整分別帶來了 1880 萬美元的非現金收益。
Our cash balance remains strong. The total of cash, cash equivalents and short-term investments at the end of the third quarter totaled $96.1 million compared to $100.1 million at September 30th, 2021, and compared to $104.5 million in cash and cash equivalents at December 31st, 2021.
我們的現金餘額依然強勁。第三季度末現金、現金等價物和短期投資總額為 9610 萬美元,而 2021 年 9 月 30 日為 1.001 億美元,而 2021 年 12 月 31 日現金和現金等價物為 1.045 億美元。
SCYNEXIS believes that its existing cash, cash equivalents and short-term investments will enable the company to fund its operating requirements into the second quarter of 2024. This assumption does not include any potential upside from ongoing business development activities associated with BREXAFEMME.
SCYNEXIS 認為,其現有現金、現金等價物和短期投資將使公司能夠為其 2024 年第二季度的運營需求提供資金。這一假設不包括與 BREXAFEMME 相關的持續業務發展活動的任何潛在上行空間。
I will now turn the call over to Dr. Marco Taglietti.
我現在將把電話轉給 Marco Taglietti 博士。
Marco Taglietti - CEO, President & Director
Marco Taglietti - CEO, President & Director
Thank you, Ivor. Before we close the call to the Q&A session, I want to reiterate a few key points. We are extremely proud to be at the forefront of a battle against deadly fungal pathogens with a unique asset, ibrexafungerp that can become a major player in the fight against these fungal infections. We have a PDUFA date in -- for recurrent of vulvovaginal candidiasis of November 30th about 3 weeks from now and everything is in line with our expectation to-date.
謝謝你,艾弗。在我們結束問答環節之前,我想重申幾個要點。我們非常自豪能夠站在對抗致命真菌病原體的最前沿,擁有獨特的資產 ibrexafungerp,它可以成為對抗這些真菌感染的主要參與者。我們有一個 PDUFA 日期 - 11 月 30 日外陰陰道念珠菌病復發大約 3 週後,一切都符合我們迄今為止的預期。
We plan to provide updates of our progress in MARIO, which we believe can be leveraged to build a strong and differentiated hospital brand. We remain on track to have data in early 2024 and to file our NDA with FURI and CARES data in the year with a potential approval by end of 2024.
我們計劃提供我們在 MARIO 方面的最新進展,我們相信可以利用它來建立一個強大和差異化的醫院品牌。我們仍有望在 2024 年初獲得數據,並在當年提交帶有 FURI 和 CARES 數據的保密協議,並可能在 2024 年底前獲得批准。
Our [hospital] franchise not only has the potential to generate $300 million to $400 million a year in net sale in the U.S. alone, but also it will provide significant revenues until at least 2025.
我們的 [醫院] 特許經營權不僅有可能僅在美國每年產生 3 億至 4 億美元的淨銷售額,而且至少在 2025 年之前還將提供可觀的收入。
Finally, with our recent corporate action, we have over $96 million in cash, and we have extended our cash runway into second quarter 2024. This runway does not include any upside from ongoing potential business development deals.
最後,通過我們最近的公司行動,我們擁有超過 9600 萬美元的現金,並且我們已將現金跑道延長至 2024 年第二季度。該跑道不包括正在進行的潛在業務開發交易的任何好處。
Operator, please open the floor for questions.
接線員,請打開地板提問。
Operator
Operator
Thank you. (Operator Instructions) And our first question comes from Louise Chen with Cantor.
謝謝。 (操作員說明)我們的第一個問題來自 Louise Chen 和 Cantor。
Louise Alesandra Chen - Senior Research Analyst & MD
Louise Alesandra Chen - Senior Research Analyst & MD
First question, I [had] for you is, when do you think we will see an out-licensing and/or partner for BREXAFEMME? And how do you think about valuing this opportunity? And is this year possible after your PDUFA? Or is 2023 more likely?
第一個問題,我 [had] 你認為我們什麼時候會看到 BREXAFEMME 的授權和/或合作夥伴?您如何看待這個機會?在你的 PDUFA 之後今年有可能嗎?還是 2023 年更有可能?
And then second question, I had for you is, how will you succeed? Or how do you think about succeeding in the hospital setting when others have failed? And then I have one more question, but I'll let you answer these 2 first.
然後第二個問題,我要問你的是,你將如何成功?或者當其他人都失敗時,您如何看待在醫院環境中取得成功?然後我還有一個問題,但我會讓你先回答這兩個問題。
Marco Taglietti - CEO, President & Director
Marco Taglietti - CEO, President & Director
Yes. So first of all, let me say we are very active pursuing potential partners, and well, we will just continue to keep all of you updated just to let you know that we are in very active conversations with potential partners and so stay tuned. We also, of course, on these type of things, which is we cannot really provide yet a specific commitment. Certainly, we expect to be, as I mentioned, the approval of recurrent VVC, which we expect it to arrive at the end of this month. So in 3 weeks from now. As you well know, Louise, we expect this to continue to create interest in potential partners.
是的。所以首先,讓我說我們非常積極地尋找潛在合作夥伴,好吧,我們將繼續讓你們所有人了解最新情況,只是想讓你們知道我們正在與潛在合作夥伴進行非常積極的對話,敬請期待。當然,我們也針對這些類型的事情,我們無法真正提供具體的承諾。當然,正如我提到的那樣,我們希望獲得經常性 VVC 的批准,我們預計它會在本月底到達。所以從現在開始的 3 週內。如你所知,路易絲,我們希望這會繼續引起潛在合作夥伴的興趣。
And well, we expect that this product will be valued by potential partners because, as we mentioned before, we are looking for partners, whether the greater footprint when we can afford, whether the expertise in women health care and, most importantly, they may have other products in the bank of their reps, synergistic products that will really help to make the most out of BREXAFEMME. So, we expect that the value that BREXAFEMME can achieve in the market is going to be recognized.
好吧,我們預計該產品將受到潛在合作夥伴的重視,因為正如我們之前提到的,我們正在尋找合作夥伴,無論是在我們負擔得起的情況下更大的足跡,是否具有女性保健方面的專業知識,最重要的是,他們可能他們的代表銀行還有其他產品,協同產品將真正幫助充分利用 BREXAFEMME。因此,我們預計 BREXAFEMME 可以在市場上實現的價值將得到認可。
And the third one is for the hospital -- hospital, the hospital setting, we truly appreciate that it's also -- it can be a challenging one. But with a unique product belonging to a new class, we expect this to be certainly a product that will create interest as we have seen just on the way that we have been able to enroll patients.
第三個是針對醫院的——醫院,醫院環境,我們真的很感激它也是——它可能是一個具有挑戰性的。但是,對於屬於新類別的獨特產品,我們希望這肯定會引起人們的興趣,正如我們在能夠招募患者的過程中所看到的那樣。
David, I would like to add something about how this has been received from our KOLs, the use of ibrexafungerp for serious invasive fungal infections.
大衛,我想補充一些關於如何從我們的 KOL 那裡收到的信息,即使用 ibrexafungerp 治療嚴重的侵襲性真菌感染。
David Gonzalez Angulo - Chief Medical Officer
David Gonzalez Angulo - Chief Medical Officer
Sure, Marco. Luis, we believe that really the product ibrexafungerp is well differentiated to really being able to address very significant unmet needs. As you can see here, this is being recognized again and again what ibrexafungerp potential can be achieved. And so, we believe that with the right development program that we have said, focusing in the indications that are very substantial in life-threatening conditions that we have focused on and with an efficient development program being able to get a favorable label in that regard, we believe that we will be very well positioned to really have a predominant place in the market and predominant place in the treatment (inaudible) for these patients that have very limited treatment options.
當然,馬可。 Luis,我們相信 ibrexafungerp 產品確實具有很好的差異化,能夠真正解決非常重要的未滿足需求。正如您在這裡看到的,人們一次又一次地認識到 ibrexafungerp 可以實現的潛力。因此,我們相信,通過我們所說的正確的開發計劃,專注於我們所關注的危及生命條件下非常重要的跡象,並且通過有效的開發計劃能夠在這方面獲得有利的標籤,我們相信,對於這些治療選擇非常有限的患者,我們將處於非常有利的地位,能夠真正在市場上佔據主導地位,並在治療(聽不清)中佔據主導地位。
We must also remember that the antifungal space is slightly unique because of the fact that there are not so many players. There are not so many treatment options. There are not so many groups of drugs. And once the patients become resistant to 1 or 2 or intolerant to 1 or 2, their options are extraordinarily limited. So this is providing us a unique opportunity in our opinion to really maximize the potential value of ibrexafungerp in the commercial market in the hospital setting. I hope that, that addresses your question.
我們還必須記住,由於沒有那麼多玩家,抗真菌空間略有獨特。沒有太多的治療選擇。沒有那麼多的藥物組。一旦患者對 1 或 2 產生耐藥性或對 1 或 2 不耐受,他們的選擇就非常有限。因此,我們認為這為我們提供了一個獨特的機會,可以真正最大化 ibrexafungerp 在醫院環境中商業市場中的潛在價值。我希望這能解決您的問題。
Louise Alesandra Chen - Senior Research Analyst & MD
Louise Alesandra Chen - Senior Research Analyst & MD
It does. And if I could just squeeze in one more modeling question here. I think if I heard you correctly, it sounded like the fourth quarter sales will be down versus the third quarter because of some disruption. And then, I wanted to ask you about the OpEx under your new business strategy as you want things down, how should we think about OpEx in fourth quarter and then in 2023?
確實如此。如果我可以在這裡多加一個建模問題。我想如果我沒聽錯的話,聽起來第四季度的銷售額會因為一些中斷而低於第三季度。然後,我想問你關於你的新業務戰略下的運營支出,因為你想把事情搞砸,我們應該如何看待第四季度和 2023 年的運營支出?
Ivor Macleod - CFO
Ivor Macleod - CFO
So, as you have seen this actually, we have seen always positive trend in the last few quarters. And what we are saying is that at this point, we tend to be conservative. And given the fact that we are stopping active promotion in the field with the termination of our Amplity partnership. At this point, we don't expect probably future growth. So -- and we will see, as you may know, if you look at our sales through the IQVIA database on others, we continue actually right now to continue to have sales of the product, and we will continue to make the product available with regards to the patients because we want to make sure that patients who need an alternative to fluconazole, which has been the only product approved and was approved almost 30 years ago, have access to the product.
因此,正如您實際上看到的那樣,我們在過去幾個季度一直看到積極的趨勢。而我們所說的是,在這一點上,我們傾向於保守。考慮到隨著我們與 Amplity 合作夥伴關係的終止,我們將停止在該領域的積極推廣。在這一點上,我們預計未來可能不會增長。所以 - 我們會看到,正如您所知,如果您通過 IQVIA 數據庫查看我們在其他人身上的銷售情況,我們實際上現在繼續繼續銷售該產品,我們將繼續提供該產品關於患者,因為我們希望確保需要氟康唑替代品的患者能夠使用該產品,氟康唑是唯一獲批的產品,並且已在近 30 年前獲得批准。
In addition, as I mentioned before, we have some new coverage of a new BPM, adding another $30 million. So, the fact that we may be stopping promotion, may be active promotion, may be balanced by the fact that there are more patients in balance. So, we will see at the end of the quarter really how we have been doing.
此外,正如我之前提到的,我們對新的 BPM 有一些新的報導,又增加了 3000 萬美元。因此,我們可能會停止推廣,可能會積極推廣,可能會因為有更多的患者處於平衡狀態而得到平衡。因此,我們將在本季度末真正了解我們的表現。
With regard to our OpEx, operational expenses, we have not really provided the guidance. But since we are refocusing our efforts on R&D on the development of the product in invasive fungal infection. I think that as a guideline or a sense of what our OpEx will be, probably you may want to look back at our expenses in 2019, 2020, where we were, let's say, pre-commercial, and this is maybe the type of operational expenses in the range where we expect to be with a new SCYNEXIS refocused on R&D development. Does it address your question?
關於我們的運營支出、運營費用,我們還沒有真正提供指導。但由於我們正在將研發工作重新集中在侵襲性真菌感染產品的開發上。我認為作為指導或了解我們的運營支出,您可能想回顧一下我們在 2019 年和 2020 年的支出,比方說,我們處於商業化之前,這可能是運營類型費用在我們期望新 SCYNEXIS 重新專注於研發的範圍內。它是否解決了您的問題?
Louise Alesandra Chen - Senior Research Analyst & MD
Louise Alesandra Chen - Senior Research Analyst & MD
Yes.
是的。
Operator
Operator
Next question comes from Michael Higgins with Ladenburg Thalmann.
下一個問題來自 Michael Higgins 和 Ladenburg Thalmann。
Michael John Higgins - MD & Senior Biopharmaceuticals Equity Research Analyst
Michael John Higgins - MD & Senior Biopharmaceuticals Equity Research Analyst
I appreciate you taking the questions and welcome aboard, Ivor, to SCYNEXIS. David and Marco, first question for you guys. Does the inclusion of ibrexafungerp onto -- prior to pathogen list improve the chances for nondilutive funding or global partnerships? Anything you can mention in regards there?
感謝您提出問題並歡迎 Ivor 加入 SCYNEXIS。大衛和馬可,你們的第一個問題。將 ibrexafungerp 列入病原體清單之前是否會增加非稀釋性資金或全球夥伴關係的機會?關於那裡,你有什麼可以提的嗎?
David Gonzalez Angulo - Chief Medical Officer
David Gonzalez Angulo - Chief Medical Officer
This is David, Michael. So, I just want to clarify, certainly the WHO list identifies what are the priorities, the fungal diseases that they are really asking policymakers and also asking research and development organizations to focus on because they consider extraordinarily important and can have a very significant impact in public health. I didn't mentally imply that ibrexafungerp is, part of that lessor is mentioning within that WHO's leave to -- what we're showing here to you is that we have almost a perfect fit in regards to our focus or efforts of our development program versus what they have considered are the priority focus that should drive innovation in the future. That obviously is the reinforcement of our vision that we have been putting together since 2 years ago in focusing in this very difficult-to-treat and unmet medical needs in the fungal space.
這是大衛,邁克爾。所以,我只想澄清一下,當然,WHO 清單確定了優先事項,他們真正要求決策者並要求研究和開發組織關注的真菌疾病,因為他們認為非常重要並且可以對公共衛生。我並沒有在心裡暗示 ibrexafungerp 是,出租人的一部分在世衛組織的許可中提到——我們在這裡向你們展示的是,我們在我們的發展計劃的重點或努力方面幾乎完美契合與他們所考慮的相比,未來應優先推動創新。這顯然加強了我們自 2 年前以來一直專注於真菌領域這種非常難以治療和未滿足的醫療需求的願景。
How will this impact our ability to continue being successful in attractive people to our story and really investigators to our clinical trials, et cetera, we think that is important. We think that is important because the recognition of the WHO, along with the recognition -- past recognition from CDC and other organizations that these fungal pathogens represent a substantial unmet medical need and there is very welcome innovation in those areas. We believe that will potentially eventually translate into policymaking favorable conditions towards commercializing a product like us that offer that broader spectrum of activity is addressing needs not only mentioned by the company, but needs that are extraordinarily well validated by organizations worldwide. So, we see that definitely as a positive outcome, and we see definitely as a positive signal that we are in the right path.
這將如何影響我們繼續成功吸引人們關注我們的故事以及真正研究我們的臨床試驗的能力,等等,我們認為這很重要。我們認為這很重要,因為 WHO 的認可,以及 CDC 和其他組織過去的認可,這些真菌病原體代表了大量未滿足的醫療需求,並且在這些領域有非常受歡迎的創新。我們相信,這可能最終轉化為政策制定的有利條件,使像我們這樣的產品商業化,提供更廣泛的活動範圍,不僅滿足公司提到的需求,而且滿足全球組織非常充分驗證的需求。所以,我們認為這絕對是一個積極的結果,我們絕對認為這是一個積極的信號,表明我們走在正確的道路上。
Ivor Macleod - CFO
Ivor Macleod - CFO
And if I can add, for example, talking about the nondilutive funding, if you think about the way BARDA has been providing grants in the field of anti-infectives, their focus has been really on antibacterial. Now, with WHO really making a very strong case that fungal infection are critical, are actually a global threat as much as bacterial infections that can change their approach. And the other is really the recognition that fungal infection are a major global, again, again, a major global threat that can help to introduce new legislations, like the PASTEUR Act, for example, or the DISARM Act because let me just say probably, Michael, I told you in the past, I was down in Washington a couple of times talking with legislators. And they still think that fungal inflation at the end of the day is a fleet foot. And of course, that is not the case. At least we are talking here about infection -- invasive infection of the bloom stream, internal organs in very sick patients, where the outcome, as we mentioned many times, the mortality can still be 25% to 40%, I mean, extremely high mortality. And I think, with the WHO report, really puts the right focus, the right emphasis on how critical these infections are.
如果我可以補充,例如,談論非稀釋資金,如果你考慮 BARDA 在抗感染領域提供資助的方式,他們的重點實際上是抗菌。現在,WHO 確實提出了一個非常有力的案例,即真菌感染很嚴重,實際上是一種全球性威脅,就像可以改變他們方法的細菌感染一樣。另一個是真正認識到真菌感染是一個重大的全球性威脅,再一次,一個重大的全球性威脅,可以幫助引入新的立法,例如《巴斯德法案》或《裁軍法案》,因為我想說的可能是,邁克爾,我過去告訴過你,我在華盛頓與立法者交談過幾次。而且他們仍然認為一天結束時的真菌膨脹是一種快速的腳步。當然,事實並非如此。至少我們在這裡談論的是感染——布盧姆流的侵入性感染,重病患者的內臟器官,結果,正如我們多次提到的,死亡率仍然可以達到 25% 到 40%,我的意思是,非常高死亡。我認為,世衛組織的報告確實正確地強調了這些感染的嚴重性。
Michael John Higgins - MD & Senior Biopharmaceuticals Equity Research Analyst
Michael John Higgins - MD & Senior Biopharmaceuticals Equity Research Analyst
That's very helpful, guys. Appreciate it. If I can turn our attention to MARIO, a design in a study that makes a lot of sense for this asset. Can you give us an update on the number of sites. I think you were going to 75%. Just want to clarify if that's where you're going to, if that's increased and how the enrollment is going so far?
這很有幫助,伙計們。欣賞它。如果我能把注意力轉向 MARIO,一項研究中的設計對這項資產很有意義。你能告訴我們網站數量的最新情況嗎?我想你會達到 75%。只是想澄清一下您是否要去那裡,是否有所增加以及到目前為止的入學情況如何?
David Gonzalez Angulo - Chief Medical Officer
David Gonzalez Angulo - Chief Medical Officer
Yes. Certainly, yes, the number of sites that we have planned has not changed. So we are in the process of the start-up of the study, as I mentioned. You know that we typically don't guide on enrollment in an ongoing basis. However, I can tell you that the trajectory of the study in terms of site initiations, approvals in different countries, et cetera, is as we have been expecting. So, everything seems to be on track for us really being able to complete the study -- to complete the enrollment of the study as we are estimating right now by end of next year. So, at this point, yes, very, very intense activities happening. Really what happens at this stage is that you go out to all regulatory agencies, different countries when we are opening centers, et cetera, and we have been receiving positive response from that point of view. So, approvals are coming, and we are just in the process of really setting up all the sites and we'll get them ready. And we have already several sites already open, as you know.
是的。當然,是的,我們計劃的站點數量沒有改變。正如我提到的,我們正處於研究的啟動過程中。您知道我們通常不會持續指導註冊。但是,我可以告訴您,該研究在地點啟動、不同國家/地區的批准等方面的軌跡與我們一直期待的一樣。因此,對於我們真正能夠完成研究而言,一切似乎都在按計劃進行——按照我們目前的估計,到明年年底完成研究的註冊。所以,在這一點上,是的,非常非常激烈的活動正在發生。在這個階段真正發生的事情是,當我們開設中心時,你會去所有監管機構、不同的國家等等,從這個角度來看,我們已經收到了積極的回應。所以,批准即將到來,我們只是在真正建立所有網站的過程中,我們會讓它們準備就緒。如您所知,我們已經開放了幾個站點。
Michael John Higgins - MD & Senior Biopharmaceuticals Equity Research Analyst
Michael John Higgins - MD & Senior Biopharmaceuticals Equity Research Analyst
Great clarification. Okay. Appreciate that. One last one, if I could. Any feedback for us on your conversations with the FDA ahead of the November 30 PDUFA?
很好的澄清。好的。感謝。最後一張,如果可以的話。對我們在 11 月 30 日 PDUFA 之前與 FDA 的對話有何反饋?
David Gonzalez Angulo - Chief Medical Officer
David Gonzalez Angulo - Chief Medical Officer
We don't -- actually we didn't -- this particular supplemental NDA did not requires a late cycle or any type of conversation with the FDA. They didn't consider that an additional conversation was needed. And we are just in the normal stages of this particular process, which is the really understanding what is their comments, et cetera, within our label. Those are the stages that we are currently at. And all the signs are currently positive towards the -- all expectations of an approval are at the PDUFA date.
我們沒有——實際上我們沒有——這個特殊的補充 NDA 不需要延遲週期或與 FDA 進行任何類型的對話。他們認為不需要進行額外的對話。我們正處於這個特定過程的正常階段,也就是真正了解他們在我們的標籤中發表的評論等等。這些是我們目前所處的階段。目前所有跡像都對 - 批准的所有預期都是在 PDUFA 日期。
Michael John Higgins - MD & Senior Biopharmaceuticals Equity Research Analyst
Michael John Higgins - MD & Senior Biopharmaceuticals Equity Research Analyst
Appreciate all the feedback.
感謝所有反饋。
Operator
Operator
Next question comes from Shubhendu Sen Roy with Brookline Capital Markets.
下一個問題來自 Brookline Capital Markets 的 Shubhendu Sen Roy。
Shubhendu Sen Roy
Shubhendu Sen Roy
So, does the increased enrollment in the (inaudible), does that impact your funds in any way going to the added costs? And I was just wondering how do you plan to use the extra patients that are enrolling?
那麼,(聽不清)入學人數的增加是否會以任何方式影響您的資金以增加成本?我只是想知道您打算如何使用正在註冊的額外患者?
Marco Taglietti - CEO, President & Director
Marco Taglietti - CEO, President & Director
Sorry, the first question regarding the increase in the enrollment that is increasing our cost. Yes, I'm going to address that first. Thank you for the question first. Certainly, as you can imagine, with this is program that has been running for several years so far, you really need to notify the investigators with sufficient advance notice when you're planning to really stop enrollment in 1 of your trials. And this trial has been -- the FURI study has been extraordinarily well received. And I can tell you that the majority of our investigators are very disappointed that we're stopping enrollment, because this trial has giving them the opportunity to offer ibrexafungerp when other products have entirely failed. So, they really saw this protocol as something that they really wanted to really continue running for multiple years.
抱歉,第一個問題是關於增加我們的成本的入學人數增加。是的,我要先解決這個問題。先謝謝你的提問。當然,正如您可以想像的那樣,由於這個項目到目前為止已經運行了幾年,所以當您打算真正停止參加其中一項試驗時,您確實需要充分提前通知研究人員。這項試驗已經——FURI 研究受到了非常好的歡迎。我可以告訴你,我們的大多數研究人員對我們停止招募感到非常失望,因為這項試驗讓他們有機會在其他產品完全失敗時提供 ibrexafungerp。所以,他們真的把這個協議看作是他們真正想要繼續運行多年的東西。
However, as you know, we said, listen, our target enrollment is 200. We have anticipated that we were going to be completing the study towards the end of this year based on the trajectory that we saw at the beginning of the year. We had communicated that to the investigators kind of preparing them for the process. And we decided to really try to maintain the same communication to maintain the same trust with investigators and really to keep the subject enrolling until the end of this year. The incremental cost is minimal, to be honest, because the reality is that you do have -- although the cost of a clinical trial are mostly associated with all the infrastructure that needs to be in place. There is some costs associated with the specific number of subjects enrolled, but that's not the main driver. And in our opinion, that was the right decision to enable the investigators to maintain, engage with us, which many of them are the same investigators that we're using for FURI and at the same time, to really maintain the type of communication that we have been maintaining with them and keep them, as I mentioned, motivated from that point of view.
但是,如您所知,我們說過,聽著,我們的目標入學人數是 200 人。我們預計,根據年初看到的軌跡,我們將在今年年底完成這項研究。我們已經將這一點傳達給了調查人員,讓他們為這個過程做好準備。我們決定真正嘗試保持相同的溝通,以保持與調查人員的相同信任,並真正將受試者招募到今年年底。說實話,增加的成本是最小的,因為現實是你確實有——儘管臨床試驗的成本主要與所有需要到位的基礎設施有關。註冊科目的具體數量會產生一些成本,但這不是主要驅動因素。在我們看來,這是正確的決定,可以讓調查人員與我們保持聯繫,與我們接觸,他們中的許多人就是我們為 FURI 使用的調查人員,同時,真正保持溝通的類型正如我所提到的,我們一直與他們保持聯繫,並從這個角度保持他們的積極性。
And your second question, can you remind me of that?
你的第二個問題,你能提醒我嗎?
Shubhendu Sen Roy
Shubhendu Sen Roy
Yes. I was just wondering how you saw the extra patients that are coming in, how do you plan to use that?
是的。我只是想知道您如何看待即將到來的額外患者,您打算如何使用它?
David Gonzalez Angulo - Chief Medical Officer
David Gonzalez Angulo - Chief Medical Officer
The data from these patients that are coming in?
來自這些正在進來的患者的數據?
Shubhendu Sen Roy
Shubhendu Sen Roy
Yes. I mean, yes, like the data now, are you going to look at some extra parameters or just would they be part of the usual trial and they will be just included in?
是的。我的意思是,是的,就像現在的數據一樣,您是要查看一些額外的參數,還是只是將它們作為常規試驗的一部分,並將它們包含在其中?
David Gonzalez Angulo - Chief Medical Officer
David Gonzalez Angulo - Chief Medical Officer
So let me see if I understood this right. So, how are we -- for the patients that are coming in, what are we planning? So, the next step for this particular study is that, as we mentioned before, once we have the last subject last visit that we complete all the follow-up for all the patients, all patients will be analyzed via data review committee. They will be part -- all of them will be part of the same package of analysis. And along with the CARES subjects coming from CARES, and this, as you know, are open-label studies. So, we are planning to contrast the response and outcomes rate from these groups from the patients coming from FURI and CARES with external controls. And we do have right now access to good external data sets that we consider are going to be extraordinarily relevant for providing that comparison against external controls. And that is the way that we're planning really to first report the outcome of all the patients from FURI and CARES and then report later on to really being able to compare against the external controls.
所以讓我看看我是否理解正確。那麼,我們如何 - 對於即將到來的患者,我們有什麼計劃?因此,這項特定研究的下一步是,正如我們之前提到的,一旦我們完成了對所有患者的所有隨訪,我們將通過數據審查委員會對所有患者進行分析。它們將成為一部分——所有這些都將成為同一個分析包的一部分。以及來自 CARES 的 CARES 主題,如您所知,這是開放標籤研究。因此,我們計劃將這些來自 FURI 和 CARES 患者的反應和結果率與外部對照進行對比。我們現在確實可以訪問良好的外部數據集,我們認為這些數據集對於提供與外部控制的比較非常相關。這就是我們真正計劃首先報告來自 FURI 和 CARES 的所有患者的結果,然後再報告真正能夠與外部控制進行比較的方式。
These 2 pieces are what we are expecting will be supportive of a salvage therapy indication. So, we are expecting that the FURI and CARES data, along with the comparison with external controls, will be supportive of a salvage therapy indication. That's -- I'm not sure if I'm addressing your question, but that's the way that we are planning to use the data from these patients.
這 2 件是我們所期望的,它們將支持挽救治療的適應症。因此,我們預計 FURI 和 CARES 數據以及與外部對照的比較將支持挽救治療的適應症。那是——我不確定我是否在回答你的問題,但這就是我們計劃使用這些患者數據的方式。
Shubhendu Sen Roy
Shubhendu Sen Roy
Yes. Great. It does. And a follow-up for FURI study, like it includes a basket of indications in the trial, and you've shared some preliminary data as well. So, do you see one or few of the indications responding better than the others?
是的。偉大的。確實如此。以及 FURI 研究的後續行動,比如它在試驗中包括了一籃子適應症,你也分享了一些初步數據。那麼,您是否看到一個或幾個適應症比其他適應症反應更好?
David Gonzalez Angulo - Chief Medical Officer
David Gonzalez Angulo - Chief Medical Officer
So, we know that glucan synthase inhibitors are gold standard for the treatment of Candida infections, gist specifically, if I understand here the question right. So, yes, what we do expect that really gist infections, which are glucan synthase inhibitors are cited for gist infections. That's really their kind of a wow factor for this mechanism of action. So, reality is that our expectation is that future -- the majority of the patients in the FURI study, et cetera, have been enrolled with Candida infections.
所以,我們知道葡聚醣合酶抑製劑是治療念珠菌感染的金標準,具體要點,如果我理解這裡的問題是正確的。所以,是的,我們確實期望真正的要點感染,即葡聚醣合酶抑製劑被引用為要點感染。對於這種作用機制,這確實是他們令人驚嘆的因素。所以,現實情況是,我們的預期是未來——FURI 研究中的大多數患者,等等,都患有念珠菌感染。
And that is what we -- when we believe that is potentially the greatest opportunity for ibrexafungerp in gist infections. Having said that, the protocol also allows the treatment of mold infections when they are failing and/or the use of ibrexa in combination therapy to treat very difficult-to-treat mold infections like mucormycosis or aspergilosis. So with that, we are allowing all these different strategies of treatment that once we have the final results, we believe that all of them will be extraordinarily valuable as an additional alternative options for physicians when they are facing with these very difficult-to-treat infections.
這就是我們——當我們認為這可能是 ibrexafungerp 在 gist 感染中的最大機會時。話雖如此,該方案還允許在黴菌感染失敗時進行治療和/或在聯合療法中使用 ibrexa 來治療非常難以治療的黴菌感染,如毛黴菌病或曲霉菌病。因此,我們允許所有這些不同的治療策略,一旦我們得到最終結果,我們相信所有這些都將非常有價值,作為醫生面對這些非常難以治療的疾病時的額外替代選擇感染。
Shubhendu Sen Roy
Shubhendu Sen Roy
Yes. That's very helpful. And finally, I may have missed it, but what is the time line for [synergia] study?
是的。這很有幫助。最後,我可能錯過了,但是 [協同] 研究的時間表是什麼時候?
David Gonzalez Angulo - Chief Medical Officer
David Gonzalez Angulo - Chief Medical Officer
We are planning to report data. We're closing -- we're planning to really close enrollment within this year as well, and we've been able to report data in the first half of next year.
我們計劃報告數據。我們正在關閉——我們也計劃在今年內真正關閉註冊,我們已經能夠在明年上半年報告數據。
Operator
Operator
(Operator Instructions) This concludes our question-and-answer session. I would like to turn the conference back over to Marco Taglietti, President and CEO, for any closing remarks. Please go ahead.
(操作員說明)我們的問答環節到此結束。我想將會議轉回給總裁兼首席執行官 Marco Taglietti,聽取任何閉幕詞。請繼續。
Marco Taglietti - CEO, President & Director
Marco Taglietti - CEO, President & Director
Thank you very much, operator. I would like just to make 3 simple points. The first one, we are very proud to have an asset like ibrexafungerp that will make a significant difference to patients within basic fungal infections. The second is that we have expertise and the resources to achieve our goals. And the third that we believe that we are on a path that will make SCYNEXIS successful, and we'll be able not only to help patients, but also to reward our shareholders. And thank you very much for your attention and looking forward to continue to work with all of you. Thank you.
非常感謝你,接線員。我只想提出 3 個簡單的觀點。第一個,我們非常自豪擁有像 ibrexafungerp 這樣的資產,它將對基本真菌感染的患者產生重大影響。第二是我們擁有實現目標的專業知識和資源。第三,我們相信我們正走在使 SCYNEXIS 成功的道路上,我們不僅能夠幫助患者,而且能夠回報我們的股東。非常感謝您的關注,期待與大家繼續合作。謝謝。
Operator, you can close the conference call.
接線員,您可以關閉電話會議。
Operator
Operator
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。