使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主
Operator
Operator
Yes, good morning, ladies and gentlemen, and welcome to the Bio-Path Holdings Full Year 2023 earnings conference call. (Operator Instructions) Please also note today's event is being recorded. At this time, I'd like to turn the floor over to Will O'Connor of Stern Investor Relations. Please proceed.
是的,早上好,女士們、先生們,歡迎參加 Bio-Path Holdings 2023 年全年收益電話會議。 (操作員說明)也請注意今天的活動正在錄製中。現在,我想請史特恩投資者關係部的威爾·奧康納發言。請繼續。
Will O'Connor - IR
Will O'Connor - IR
Thank you, operator. Welcome to the Bio-Path Holdings conference call and webcast to review the company's full year 2023 financial results and to provide an update on recent pipeline and corporate developments.
謝謝你,接線生。歡迎參加 Bio-Path Holdings 電話會議和網路廣播,回顧該公司 2023 年全年財務業績,並提供有關最新產品線和公司發展的最新資訊。
Earlier today, we issued a press release, which outlines the topics that we plan to discuss on the call. The release is available at bio-pathholdings.com. With me today from Bio-Path are President and CEO, Peter Nielsen, and Senior Vice President of Finance Accounting and Administration, Anthony Price.
今天早些時候,我們發布了一份新聞稿,概述了我們計劃在電話會議上討論的主題。此版本可在 bio-pathholdings.com 上取得。今天與我同在的有 Bio-Path 總裁兼執行長 Peter Nielsen 以及財務會計與管理資深副總裁 Anthony Price。
Before we begin the call, I'd like to remind you that today's discussion will contain forward-looking statements that involve risks and uncertainties. These risks and uncertainties are outlined in today's press release and in the Company's recent filings with the Securities and Exchange Commission, which we urge you to read. Our actual results may differ materially from what is discussed on today's call.
在我們開始通話之前,我想提醒您,今天的討論將包含涉及風險和不確定性的前瞻性陳述。這些風險和不確定性在今天的新聞稿和公司最近向美國證券交易委員會提交的文件中進行了概述,我們強烈建議您閱讀這些文件。我們的實際結果可能與今天電話會議中討論的內容有重大差異。
With that, I'll now turn the call over to Bio-Path CYO, Peter Nielsen.
現在,我將把電話轉給 Bio-Path CYO Peter Nielsen。
Peter Nielsen - Co-Founder, Chairman of the Board, CEO, President, CFO & Treasurer
Peter Nielsen - Co-Founder, Chairman of the Board, CEO, President, CFO & Treasurer
Thanks, Wil. Good morning, everyone, and thank you for joining us genetic approaches to the treatment of cancer are getting their care they deserve as these technologies are finally making meaningful clinical advances. And our DNA ligase platform is a perfect example of that. We made significant progress throughout last year across our pipeline, and I'm excited to share these updates with you today. Our antisense DNA can be delivered in high doses to target cells through the blood and lymphatic system with no evidence of toxicity in patients in clinical trials to date, which is in contrast to other lipid delivery technologies with dose limiting toxicities.
謝謝,威爾。大家早安,感謝您加入我們,癌症治療的基因方法正在得到應有的照顧,因為這些技術終於取得了有意義的臨床進展。我們的 DNA 連接酶平台就是一個完美的例子。去年我們在管道方面取得了重大進展,我很高興今天與您分享這些更新。我們的反義 DNA 可以透過血液和淋巴系統以高劑量遞送至目標細胞,迄今為止在臨床試驗中沒有證據表明患者存在毒性,這與其他具有劑量限制毒性的脂質遞送技術形成鮮明對比。
This is what continues to excite us and the data we saw throughout to 2023 corroborates that and I'll begin with the progress we have made with our lead product candidate, prexigebersen. As you know, last year, we reported positive interim results from Stage two of our Phase 2 clinical trial of prexigebersen for the treatment of acute myeloid leukemia or AML in combination with frontline therapy decided and venetoclax. Recall the study is an amended Stage two of our Phase two trial in AML.
這繼續讓我們興奮不已,我們在 2023 年之前看到的數據也證實了這一點,我將從我們的主要候選產品 prexigebersen 取得的進展開始。如您所知,去年,我們報告了 prexigebersen 與一線治療決定和 Venetoclax 聯合治療急性髓性白血病或 AML 的 2 期臨床試驗的第二階段的積極中期結果。回想一下,這項研究是我們 AML 第二階段試驗的第二階段修訂版。
It is an open-label two stage multi-center study of prexigebersen in combination with decided and venetoclax in two cohorts of patients with previously untreated AML and relapsed resistant AML. The third cohort includes treating relapsed resistant AML patients for venetoclax resistant or intolerant with the two drug combinations appreciate your Burress and decided the primary endpoint for this study will be the number of patients who achieve complete remission, which includes complete remission with incomplete amount of Dyloject recovery and complete remission with partial hematologic recovery.
這是一項開放標籤的兩階段多中心研究,在兩組先前未經治療的 AML 和復發性抗藥性 AML 患者中,將 prexigebersen 與決定和 Venetoclax 聯用。第三組包括治療復發性抗藥性AML 患者,使用兩種藥物組合對Venetoclax 抗藥性或不耐受,感謝您的Burress,並決定本研究的主要終點將是實現完全緩解的患者數量,其中包括使用不完全量的Dyloject 實現完全緩解的患者數量恢復和完全緩解,部分血液學恢復。
Efficacy data from the initial interim analysis of cohort one and cohort two were compelling and show that prexigebersen based combination therapy was not only safely administered in Cohort one and two to high risk newly diagnosed and refractory relapsed AML patients considered unsuitable for standard chemotherapy, but also demonstrated efficacy signals better than current therapies.
第一組和第二組的初步中期分析的療效數據令人信服,表明基於prexigebersen 的聯合療法不僅可以安全地在第一組和第二組中對被認為不適合標準化療的高風險新診斷和難治性復發AML 患者進行治療,而且顯示出比目前療法更好的療效訊號。
This is particularly encouraging as refractory relapse patients are a challenging population in which current treatment options or suboptimal. On the strength of these data, we currently plan to pursue US Food and Drug Administration or FDA expedited programs for fast track designation for Bio-Path prexigebersen AML treatments in patients who cannot tolerate intensive chemotherapy treatments without unacceptable side effects. The outcome in these AML patients who are unable to receive intensive chemotherapy remains dismal. These patients have a median survival of only 5 to 10 months and represent a clear and serious unmet need that Bio-Path makes We look forward to keeping you apprised of our progress progress.
這是特別令人鼓舞的,因為難治性復發患者是一個具有挑戰性的人群,其中當前的治療方案或不理想。根據這些數據,我們目前計劃尋求美國食品和藥物管理局或 FDA 的快速通道指定計劃,為無法耐受強化化療且不會產生不可接受的副作用的患者提供 Bio-Path prexigebersen AML 治療。這些無法接受強化化療的 AML 患者的結果仍然令人沮喪。這些患者的中位存活期僅為 5 至 10 個月,代表了 Bio-Path 明確且嚴重的未滿足需求。我們期待隨時向您通報我們的進展。
On the regulatory front, in October, we hosted a key opinion leader that to discuss the evolving treatment landscape in AML, we were privileged to have Dr. Jorge Cortes and Dr. Barrow Hanley and two luminaries in the hematology oncology space. As our guest speakers, the discussion was illuminating and engaging bolstering our conviction in the prexigebersen clinical development program as both physician experts were deeply encouraged by our interim results and further underscored the great unmet medical need of these patients.
在監管方面,10 月份,我們接待了一位關鍵意見領袖,討論 AML 不斷發展的治療前景,我們很榮幸邀請到 Jorge Cortes 博士和 Barrow Hanley 博士以及血液腫瘤學領域的兩位傑出人物。作為我們的演講嘉賓,討論具有啟發性和吸引力,增強了我們對prexigebersen 臨床開發計劃的信念,兩位醫師專家都對我們的中期結果深感鼓舞,並進一步強調了這些患者尚未得到滿足的巨大醫療需求。
It was heartwarming to have these AML specialists highlight the fact that results of this magnitude are simply not seen in these patients having this independent expert point of view that supports Bio-Path mission was inspiring. I encourage you all to listen to the archive of this event, which is available on our website.
這些 AML 專家強調這樣一個事實,即在這些患者中根本看不到如此巨大的結果,這種支持 Bio-Path 使命的獨立專家觀點令人鼓舞,這令人感到溫暖。我鼓勵大家收聽本次活動的檔案,該檔案可在我們的網站上找到。
Turning now to BP1002 program, which targets BCL2. As you know, Bcl-2 is responsible for driving cell survival in up to 60% of all cancers. High expression of Bcl-2 has been correlated with poor prognosis for patients diagnosed with AML with medical access shown activity against the anti updated protein Bcl-2 and works by neutralizing the protein's BH. three domain. It is an approved treatment for chronic lymphocytic leukemia or CLL patients and untreated AML patients.
現在轉向針對 BCL2 的 BP1002 計畫。如您所知,Bcl-2 負責促進高達 60% 的所有癌症的細胞存活。 Bcl-2 的高表達與診斷為 AML 的患者的不良預後相關,這些患者的醫療途徑顯示出針對抗更新蛋白 Bcl-2 的活性,並透過中和該蛋白的 BH 發揮作用。三個域。它是一種批准的治療慢性淋巴細胞白血病或 CLL 患者以及未經治療的 AML 患者的方法。
However, with the exception of some patients treated with allogenic hematopoietic cell transplantation as these relapse invariably occurs, oftentimes due to BH. three domain mutation over time, BP. one zeros or two, also targets BCLP. protein. However, BP. one zero zero two activity is based on blocking the Bcl-2 messenger RNA and not the BH. three domain. As a result, we believe BP. one zero zero two could provide an alternative for venetoclax patients who have relapsed, including AML patients who previously received venetoclax treatments. In December, we announced the completion of the first dose cohort of the dose escalation portion of our Phase one 1b clinical trial, IBP. one zero or two to treat refractory relapsed AML, including venetoclax resistant patients.
然而,除了一些接受同種異體造血細胞移植治療的患者外,這些患者總是會復發,通常是由於 BH 所致。隨著時間的推移,三個域發生突變,BP。一個零或兩個,也針對 BCLP。蛋白質。然而,英國石油公司。一零零二活性是基於阻斷 Bcl-2 信使 RNA,而不是 BH。三個域。因此,我們相信 BP。一零零二可以為復發的 Venetoclax 患者提供替代方案,包括先前接受 Venetoclax 治療的 AML 患者。 12 月,我們宣布完成了 1b 期臨床試驗 IBP 劑量遞增部分的第一個劑量隊列。一零或二用於治療難治性復發性 AML,包括維奈托克抗藥性患者。
A total of three evaluable patients per dosing cohort are scheduled to be treated with BP. one zero zero to monotherapy in a standard three plus three design unless there is a dose-limiting toxicity, which would require an additional three patients tested the first dose cohort consisting of starting dose of 20 milligrams per square meter and there were no dose limiting toxicities, and enrollment is now open for patients for the second dose cohort of 40 milligram per square meter. The approved treatment cycle is two doses per week over four weeks for a total of eight doses administered over 28 days.
每個給藥隊列總共有三名可評估的患者計劃接受 BP 治療。標準三加三設計中的一零零至單一療法,除非存在劑量限制性毒性,這將需要另外三名患者進行測試第一劑量組由每平方米20 毫克的起始劑量組成,並且沒有劑量限制性毒性,第二個劑量組(每平方公尺 40 毫克)的患者現已開始招募。核准的治療週期是在四週內每週注射兩劑,在 28 天內總共注射八劑。
The Phase 1b portion of the study is expected to commence after completion of BP. one zero zero two monotherapy cohorts, and we'll assess the safety and efficacy of BP. one zero zero two in combination with the site even in refractory relapsed AML patients. In January, we announced completion of the first dose cohort of the dose escalation portion of our Phase one clinical trial of BP. one zero or two, evaluating VP. one zero zero two for the treatment of refractory relapsed lymphoma and refractory relapse, chronic lymphocytic leukemia or CLL. A total of six evaluable patients will be treated with BP. one zero zero to monotherapy over two dosing cohorts in a standard three plus three design with a starting dose of 20 milligram per square meter. The approved treatment cycle for two doses per week over four weeks, resulting in eight doses administered over 28 days.
該研究的 1b 期部分預計將在 BP 完成後開始。零零兩個單一療法隊列,我們將評估 BP 的安全性和有效性。即使在難治性復發性 AML 患者中,也可以將一零零二與該部位結合。一月份,我們宣布完成 BP 一期臨床試驗劑量遞增部分的第一個劑量隊列。一零或二,評估VP。一零零二用於治療難治性復發性淋巴瘤和難治性復發性慢性淋巴性白血病或CLL。總共六名可評估的患者將接受 BP 治療。在標準三加三設計中,在兩個劑量組中進行一零零至單一療法,起始劑量為每平方公尺 20 毫克。核准的治療週期為在四週內每週注射兩劑,從而在 28 天內注射八劑。
Enrollment is now open for patients for the second dose cohort of 40 milligram per square meter. The primary endpoint of the study is to evaluate the safety and tolerability of escalating doses of BP. one zero zero two, and we look forward to keeping you apprised of our progress here.
第二組劑量為每平方公尺 40 毫克的患者現已開始接受註冊。研究的主要終點是評估逐漸增加血壓劑量的安全性和耐受性。一零零二,我們期待向您通報我們的進展。
Now let's turn to our Phase 11b clinical trial of BP. one zero zero one dash A. impairment in patients with solid tumors, including ovarian and we have a trial, pancreatic and triple-negative breast cancer, some of the most challenging cancers to treat with today's therapeutic toolkit. BP. one zero zero one dash eight is a modified product from prexigebersen sharing the same drug substance with enhanced nanoparticle properties. This trial is being conducted at several leading cancer centers and will initially evaluate the safety in solid tumor patients patients diagnosed with recurrent ovarian and endometrial cancer often have poor outcomes and is our hope that we may provide clinical benefit for such patients. We look forward to cohort completion and data readout from this study potentially later this year.
現在讓我們來看看 BP 的 11b 期臨床試驗。一零零一破折號 A.實體瘤患者的損傷,包括卵巢癌,我們有一項試驗,胰腺癌和三陰性乳腺癌,這是當今治療工具包治療中最具挑戰性的一些癌症。血壓。一零零一破八是 prexigebersen 的改良產品,具有相同的藥物成分,但具有增強的奈米顆粒特性。這項試驗正在幾個領先的癌症中心進行,將初步評估實體瘤患者的安全性。診斷為復發性卵巢癌和子宮內膜癌的患者通常預後不佳,我們希望能為此類患者提供臨床益處。我們期待今年稍後這項研究的隊列完成和數據讀出。
Finally, let's review the progress we've made with BP was those are three, which targets the staff three proteins that creates a transcription factor that regulates various tumor genetic processes such as tumor proliferation, metathesis and drug resistance.
最後,讓我們回顧一下我們在BP 方面取得的進展是這三個,它針對的是工作人員的三種蛋白質,這些蛋白質產生轉錄因子,調節各種腫瘤遺傳過程,如腫瘤增殖、複分解和抗藥性性。
Its overexpression and Advair aberrant activation characterize many cancers, including breast, lung, ovarian, liver and colon cancer activation of the SaaS three pathway in breast and ovarian cancer cells promotes tumor initiation migration and Taxol resistant. Step three also promotes five dash FU. resistance in colorectal cancer cells its role in numerous malignancies made Stat three potential cancer therapeutic targets. BP. one zero zero three is a novel liposome incorporated set three antisense of the Oxy nucleotide that efficiency efficiently reduces Stat three expression and enhances the sensitivity of breast and ovarian cancer cells to Taxol and five Dash.
它的過度表現和Advair 異常活化是許多癌症的特徵,包括乳腺癌、肺癌、卵巢癌、肝癌和結腸癌。乳腺癌和卵巢癌細胞中SaaS 三種途徑的活化促進腫瘤起始遷移和紫杉醇抗藥性。第三步也提升了五衝FU。大腸直腸癌細胞的抗藥性及其在多種惡性腫瘤中的作用使 Stat 成為三個潛在的癌症治療標靶。血壓。一零零三是一種新型脂質體,摻入了氧核苷酸的三組反義核酸,可有效降低Stat 3的表達並增強乳腺癌和卵巢癌細胞對紫杉醇和五達什的敏感性。
If you these results are in line with previous work in which BP. one zero zero three plus gemcitabine displayed enhanced antitumor activity in pancreatic ductal adenocarcinoma. Together, these results strongly suggest that BP. one zero zero three combination therapy is a novel strategy for patients with advanced solid tumors. After an extended period of testing, we have identified a method for oligo detection in plasma that we believe will enable us to complete final safety testing needed to finalize an investigational new drug application or an IND with submission to the FDA. We are particularly excited to launch our first in-human validation of this cutting-edge therapy in an especially challenging cancer indication indication that has limited treatment options.
如果你這些結果與 BP 之前的工作相符。一零三加吉西他濱在胰臟導管腺癌中顯示出增強的抗腫瘤活性。總之,這些結果強烈表明 BP。一零零三聯合療法是針對晚期實體瘤患者的新策略。經過長時間的測試,我們已經確定了一種在血漿中檢測寡核苷酸的方法,我們相信該方法將使我們能夠完成最終的安全測試,以完成研究性新藥申請或向 FDA 提交 IND。我們特別高興能夠在治療選擇有限的特別具有挑戰性的癌症適應症中啟動這種尖端療法的首次人體驗證。
With that, I'll now turn the program over to Anthony Price for a brief overview of our financials along with balance sheet highlights. Anthony?
現在,我將把該計劃交給安東尼·普萊斯,簡要概述我們的財務狀況以及資產負債表要點。安東尼?
Anthony Price - SVP of Finance, Accounting & Administration
Anthony Price - SVP of Finance, Accounting & Administration
Thanks, Peter. The company reported a net loss of $16.1 million or $33.63 per share for the year ended December 31, 2023 compared to a net loss of $13.9 million or $38.12 per share for the year ended December 31, 2022. Research and development expense for the year ended December 31, 2023 increased to $11.6 million compared to $9.2 million for the year ended December 31, 2022, primarily due to manufacturing expenses related to drug product releases in 2023, as well as an increase in expense related to our clinical trial for prexigebersen in AML due to increased patient enrollment in 2023.
謝謝,彼得。該公司報告截至2023年12月31日止年度的淨虧損為1610萬美元或每股33.63美元,而截至2022年12月31日止年度的淨虧損為1390萬美元或每股38.12美元。截至2023年12月31日止年度的研發費用2023年12月31日增加至1160萬美元,而截至2022年12月31日的年度為920萬美元,主要是由於與2023年藥品發布相關的製造費用,以及與我們的prexigebersen在AML中的臨床試驗相關的費用增加由於 2023 年患者入組人數增加。
General and administrative expense for the year ended December 31, 2023 decreased to $4.2 million compared to $4.7 million for the year ended December 31, 2022, primarily due to decreased salaries and benefits expense as well as franchise tax expenses change in fair value of the company's warrant liability for the year ended December 31, 2023, resulted in a noncash loss of $0.3 million. The company did not have the warrant liability in 2022.
截至2023年12月31日止年度的一般及行政費用從截至2022年12月31日止年度的470萬美元減少至420萬美元,主要是由於工資和福利費用減少以及特許經營稅費用對公司公允價值的變動截至 2023 年 12 月 31 日止年度的認股權證負債導致非現金損失 30 萬美元。本公司2022年度不存在認股權證責任。
As of December 31, 2023, company had cash of $1.1 million compared to $10.4 million as of December 31, 2022. Net cash used in operating activities for the year ended December 31, 2023 was $11.5 million compared to $15.1 million for the comparable period in 2022. Net cash excuse me, net cash provided by financing activities for the year ended December 31, 2023 was $2.2 million.
截至2023年12月31日,公司擁有現金110萬美元,而截至2022年12月31日為1040萬美元。截至2023年12月31日止年度經營活動使用的現金淨額為1150萬美元,而2023年同期為1510萬美元。2022 年。淨現金請問,截至2023年12月31日的年度融資活動提供的淨現金為220萬美元。
With that, I'll now turn the call back over to Peter.
這樣,我現在將把電話轉回給彼得。
Peter Nielsen - Co-Founder, Chairman of the Board, CEO, President, CFO & Treasurer
Peter Nielsen - Co-Founder, Chairman of the Board, CEO, President, CFO & Treasurer
Thanks, Anthony. Because I hope you'll agree, 2023 was a year of focused execution for Bio-Path, as evidenced by the continued progress across our pipeline of DNA mobilize programs. As we look to the months and year ahead, we expect to build on the clinical progress key to date to bring potentially life-saving new medicines to patients battling cancers.
謝謝,安東尼。因為我希望您會同意,2023 年是 Bio-Path 重點執行的一年,我們的 DNA 動員計畫管道的持續進展就證明了這一點。展望未來幾個月和一年,我們期望在迄今為止關鍵的臨床進展的基礎上,為癌症患者帶來可能挽救生命的新藥。
With that, operator, we're ready to open the call for questions.
接線員,我們就準備開始提問了。
Operator
Operator
(Operator Instructions) Jonathan Ashcroft, Roth MKM.
(操作員說明)Jonathan Ashcroft,Roth MKM。
Jonathan Aschoff - Analyst
Jonathan Aschoff - Analyst
Thank you.
謝謝。
Good morning, Peter. On my first question's about projects may say, look for fast track on patients who can't tolerate intensive chemo. So what's in AML? What's the size of that market? And is anything currently happening right now with clinical development of Praxair, is it awaiting that fast track designation, Tino specifically target to the can't tolerate intensive chemo?
早安,彼得。關於我的第一個問題,關於計畫可能會說,尋找無法耐受強化化療的患者的快速通道。那麼 AML 中有什麼內容呢?這個市場有多大?目前普萊克斯的臨床開發有什麼進展嗎?是否正在等待快速通道指定,蒂諾專門針對無法耐受強化化療的患者?
Peter Nielsen - Co-Founder, Chairman of the Board, CEO, President, CFO & Treasurer
Peter Nielsen - Co-Founder, Chairman of the Board, CEO, President, CFO & Treasurer
I think our drug is pretty unique in being able to three the fragile patients. Ours is, of course, a genetic approach. We're not a toxic or poison the time that kills cells. And so that inherently it makes our patients. You don't have a better shot at terms of tolerability. It's interesting. We've paused our Cohort one and two new enrollment as we complete wrapping up. So first phase of the Phase two stage two. And we have noted we have two patients in seven-months of treatment and one patient in eight months and just has that benefit.
我認為我們的藥物非常獨特,能夠治療三名脆弱的患者。當然,我們採用的是遺傳方法。我們不是毒藥,也不是殺死細胞的毒藥。因此,它本質上使我們的患者變得如此。就容忍度而言,你沒有更好的機會。這真有趣。當我們完成總結時,我們已經暫停了第一和第二隊列的新註冊。所以第一階段是第二階段第二階段。我們注意到,我們有兩名患者接受了七個月的治療,一名患者接受了八個月的治療,並且剛剛獲得了這種好處。
I can't recall the numbers up I think it's in the 10,000 range in patients.
我記不清具體數字了,我認為患者人數在 10,000 人左右。
A lot of it is older than 60 patients, which have had a more difficult time. And like I said, in the notes. If they can't tolerate the chemotherapy with adequate tax, their survivability is not very good. So we think it's a good market and it specializes obviously, we enhance the venetoclax treatment and because all we do is make that job easier because with our messenger RNA treatment, there's less BCI. Bcl two proteins for venetoclax to operate on. So I wouldn't be surprised in the maturation of the treatment that in fact, you probably might see some extension of the effectiveness of venetoclax before you get to the point that the a different approach to addressing Bcl-2 protein has to be you.
其中很多是60歲以上的患者,他們經歷過更困難的時期。就像我在筆記中所說的。如果他們不能耐受足夠的化療,他們的生存能力就不是很好。因此,我們認為這是一個很好的市場,而且它的專業化明顯,我們加強了Venetoclax 治療,因為我們所做的就是讓這項工作變得更容易,因為透過我們的信使RNA 治療,BCI 會減少。 Bcl 是 Venetoclax 作用的兩種蛋白質。因此,對於治療的成熟,我不會感到驚訝,事實上,在您必須採用另一種方法來解決 Bcl-2 蛋白問題之前,您可能會看到 Venetoclax 的有效性有所擴展。
Jonathan Aschoff - Analyst
Jonathan Aschoff - Analyst
Okay. On our 1,002 what, Tom, what dose do you start to add to what I assume would be a subsequent combo therapy trial after you're done with 20 and 40 milligrams in well on our therapy in the CLL lymphoma trial?
好的。在我們的 1,002 中,湯姆,在您完成 CLL 淋巴瘤試驗中的 20 和 40 毫克治療後,您開始添加什麼劑量到我假設的後續聯合治療試驗中?
Peter Nielsen - Co-Founder, Chairman of the Board, CEO, President, CFO & Treasurer
Peter Nielsen - Co-Founder, Chairman of the Board, CEO, President, CFO & Treasurer
Yes, that's the both the CML and AML.
是的,這就是 CML 和 AML。
We started at 20 milligrams per square meter, which is a pretty safe starting point. And and you basically the other one would be the one that's where you're finding the dose, of course of the monotherapy, and that should be 60 and be great to see that the 90 milligrams per square meter. So they'd be jumping up your 60 B. three jump the four to 90. And then once that happens, the 1b is when you then assess the combination therapy safety and use it in actual of combination therapy. So, you know, it's hard to say right now it should be 60 to 90, I would think and the field will, but we have to do the testing to have that confirmed.
我們從每平方公尺 20 毫克開始,這是一個非常安全的起點。基本上,另一個就是你找到劑量的那個,當然是單一療法,應該是 60,很高興看到每平方米 90 毫克。所以他們會跳到你的 60 B。三跳四跳到 90。一旦發生這種情況,1b 就是你評估聯合治療的安全性並在實際的聯合治療中使用它的時候。所以,你知道,現在很難說它應該是 60 到 90,我想,這個領域也會的,但我們必須進行測試來確認這一點。
Jonathan Aschoff - Analyst
Jonathan Aschoff - Analyst
Okay. And on, um, on Presstek's A. and one oh three, what cohorts would you say you're referring to from a net that would read out in 2024? And is this also still the year for a one oh three IND filing.
好的。還有,嗯,關於 Presstek 的 A. 和一哦三,你認為你指的是 2024 年將讀出的網絡中的哪些群體?今年是否仍是 1 或 3 IND 申請的一年?
Peter Nielsen - Co-Founder, Chairman of the Board, CEO, President, CFO & Treasurer
Peter Nielsen - Co-Founder, Chairman of the Board, CEO, President, CFO & Treasurer
My my recollection is on the toxicity on the solid tumor piece. So that's dash A. and there's a lot of interest in that trial and we're already enrolling and treating patients in dose two and three, I think we had three lined up one had that back out because of it could the are too sick and the so that's the one we're talking about the getting. And that one recall starts at a higher dose because it's used in Brexit universe in which there's a lot of the obviously safety evidence in the Phase two AML trials.
我的記憶是實體瘤片上的毒性。這就是破折號A。人們對這項試驗很感興趣,我們已經在招募和治療第二劑和第三劑的患者,我想我們已經排了三個隊,其中一個已經退出了,因為可能他們病得太厲害了,這就是我們正在談論的獲得。這次召回是從較高劑量開始的,因為它用於英國脫歐領域,其中在第二階段 AML 試驗中有很多明顯的安全證據。
So that when started 60, it's at 90 now if it goes another, go up co one 35. So you know 90 is what ends up being. We certainly should be able to do that because like I said, we already have one patient in that second cohort dose cohort at 90 and another one that's so trying to enroll. So I would think that could ramp and be reported on if that's where we are.
所以,當開始時是 60,現在是 90,如果再變化,則上升到 35。所以你知道 90 就是最終的結果。我們當然應該能夠做到這一點,因為就像我說的,我們在第二個劑量組中已經有一名 90 歲的患者,還有另一名患者正在努力報名。因此,我認為如果我們處於這種情況,這可能會增加並被報告。
We end up settling on 90 beds per square meter. Am I clear, Peter?
我們最終確定每平方公尺有 90 個床位。我說清楚了嗎,彼得?
Jonathan Aschoff - Analyst
Jonathan Aschoff - Analyst
Thank you very much. That was it from my question.
非常感謝。這就是我的問題。
Peter Nielsen - Co-Founder, Chairman of the Board, CEO, President, CFO & Treasurer
Peter Nielsen - Co-Founder, Chairman of the Board, CEO, President, CFO & Treasurer
Thank you, Jonathan.
謝謝你,喬納森。
Operator
Operator
And ladies and gentlemen, with that And showing no additional questions, I would like to turn the floor back over to Peter for any closing remarks.
女士們、先生們,在沒有提出任何其他問題的情況下,我想將發言權交還給彼得,讓他發表結束語。
Peter Nielsen - Co-Founder, Chairman of the Board, CEO, President, CFO & Treasurer
Peter Nielsen - Co-Founder, Chairman of the Board, CEO, President, CFO & Treasurer
Thank you, operator, and thank you again, everyone, for joining us and for your continued support of Bio-Path. Have a great day.
謝謝運營商,再次感謝大家加入我們以及對 Bio-Path 的持續支持。祝你有美好的一天。
Operator
Operator
Ladies and gentlemen, with that, we'll conclude today's conference call and presentation. We thank you for joining. You may now disconnect your lines.
女士們先生們,我們今天的電話會議和演示就到此結束。我們感謝您的加入。現在您可以斷開線路。