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
So Greetings and welcome to Oncternal Therapeutics Fourth Quarter 2023 financial results call. At this time all participants are in a listen only mode. A brief question and answer session will follow the formal presentation. (Operator Instructions) As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Richard Vincent, Chief Financial Officer. Thank you, Richard, you may begin.
歡迎參加 Oncternal Therapeutics 2023 年第四季財務業績電話會議。此時所有參與者都處於只聽模式。正式演講後將舉行簡短的問答環節。(操作員指示)謹此提醒,本次會議正在錄製中。現在我很高興向您介紹主持人,財務長理查德·文森特。謝謝你,理查德,你可以開始了。
Richard Vincent - CFO
Richard Vincent - CFO
Thank you, Alicia. Good afternoon, everyone, and thank you for joining us today. Joining me on the call this afternoon are our President and CEO, Dr. James Breitmeyer; and our CMO Dr. Salim Yazji. Today's call includes a business update and discussion of our results for the fourth quarter and full year 2023. Our 10-K for the full year 2023 was filed earlier today. Today's press release and a replay of today's call will be available on the Investor Relations section of our terminals website for at least the next 30 days. Please note that certain information discussed on today's call is covered under the Safe Harbor provisions of the Private Securities Litigation Reform Act.
謝謝你,艾莉西亞。大家下午好,感謝您今天加入我們。今天下午與我一起參加電話會議的是我們的總裁兼執行長 James Breitmeyer 博士;和我們的首席行銷官薩利姆·亞茲吉博士。今天的電話會議包括業務更新以及對我們第四季度和 2023 年全年業績的討論。我們的 2023 年全年 10-K 報表已於今天稍早提交。至少在接下來的 30 天內,我們的終端網站的投資者關係部分將提供今天的新聞稿和今天電話會議的重播。請注意,今天電話會議中討論的某些資訊受《私人證券訴訟改革法案》的安全港條款管轄。
We will be making forward-looking statements during this call about future events such as our business and product development strategies, the timing of our clinical studies, planned interim data updates, regulatory filings and our cash runway. Our actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with our business. These forward-looking statements should be considered in conjunction with and are qualified by the cautionary statements contained in today's press release and our SEC filings, including our Form 10 K for the full year ended December 31st, 2023, as filed today, this call contains time-sensitive information that is accurate only as of the date of this live broadcast, March seventh, 2024.
我們將在本次電話會議中就未來事件做出前瞻性陳述,例如我們的業務和產品開發策略、臨床研究的時間表、計劃的中期數據更新、監管備案和我們的現金跑道。由於與我們業務相關的風險和不確定性,我們的實際結果可能與這些前瞻性陳述中明示或暗示的結果有重大差異。這些前瞻性陳述應與今天的新聞稿和我們向SEC 提交的文件(包括今天提交的截至2023 年12 月31 日的全年10 K 表格)中包含的警示性聲明結合起來考慮並受到其限制,本次電話會議包含時間敏感資訊僅截至本次直播之日(2024 年 3 月 7 日)準確。
We undertake no obligation to revise or update any forward-looking statements to reflect events or circumstances occurring after the date of this call. Without that, it is my pleasure to hand the call over to our CEO, Dr. Jim Breitmeyer.
我們不承擔修改或更新任何前瞻性陳述以反映本次電話會議之後發生的事件或情況的義務。如果沒有這個,我很高興將電話轉交給我們的執行長 Jim Breitmeyer 博士。
Jim Breitmeyer - President and CEO
Jim Breitmeyer - President and CEO
Thank you, Rich, and good afternoon, everyone. At Oncternal, we are advancing two first-in-class clinical programs targeting cancers for patients with significant unmet medical need. We continue to be excited about the potential of Oct. five three four and its novel mechanism of action, which may address a significant unmet need for advanced prostate cancer patients who progressed after currently approved AR. pathway inhibitor therapy and before they move into more aggressive treatment options such as chemotherapy or radioligand therapy.
謝謝里奇,大家下午好。在 Oncternal,我們正在推動兩個針對癌症的一流臨床項目,為醫療需求未滿足的患者提供服務。我們仍然對 Oct.534 的潛力及其新穎的作用機制感到興奮,這可能會解決目前批准的 AR 後病情進展的晚期前列腺癌患者未得到滿足的重大需求。途徑抑制劑療法以及在他們轉向更積極的治療選擇(例如化療或放射配體療法)之前。
Earlier this year, we announced that for patients with metastatic castrate resistant prostate cancer had been enrolled into our Phase one two dose escalation dose expansion study of Oncophage three, four, we have been able to dose escalate as planned without unexpected dose-limiting toxicities and the third dosing cohort of 160 milligrams of Oct. five three four is now fully enrolled. We plan to announce an initial clinical data update for this program late next quarter. With respect to RADOARO. one targeting autologous CAR T. We released initial clinical data in December from Phase one two study Oct. eight oh eight one oh one. In patients with relapsed or refractory aggressive B-cell lymphoma, including patients who have failed previous CD19 CAR T therapy.
今年早些時候,我們宣布,對於轉移性去勢抵抗性前列腺癌患者,我們已將Oncophage 3、4 的一、二期劑量遞增劑量擴展研究納入其中,我們已經能夠按計劃進行劑量遞增,而不會出現意外的劑量限制毒性,並且10 月 5 日至 4 日的第三個 160 毫克劑量組現已全部入組。我們計劃在下個季度末宣布該項目的初步臨床數據更新。關於 RADOARO。一種靶向自體 CAR T。我們於 12 月發布了第一階段二期研究的初步臨床數據,即 10 月 8 點 8 點 1 點。復發性或難治性侵襲性 B 細胞淋巴瘤患者,包括先前 CD19 CAR T 治療失敗的患者。
We saw an encouraging response signal at the initial dose of one times 10 to the six CAR T cells per kilogram with two of the three patients achieving complete metabolic response and the third achieving a partial response as of the December fourth cutoff date. Common adverse events in this dosing cohort included decreased blood counts, pneumonia and Grade one two cytokine release syndrome or CRS. First patient treated at the dose level of three times 10 to the six CAR T cells per kilogram, an 80 year old with bulky disease who had received four probably previous lines of therapy, including CD19 CAR T EXPECT experienced a fatal serious adverse events consistent with CRS and immune effector cell associated neurotoxicity syndrome.
我們在每公斤6 個CAR T 細胞的1 倍10 的初始劑量下看到了令人鼓舞的反應信號,截至12 月4 日截止日期,三名患者中的兩名實現了完全代謝反應,第三名患者實現了部分反應。此劑量組常見的不良事件包括血球計數減少、肺炎和一級二級細胞因子釋放症候群或 CRS。第一個患者接受了每公斤3 倍10 到6 個CAR T 細胞的劑量水平治療,他是一位患有大塊疾病的80 歲患者,之前可能接受過四種療法,包括CD19 CAR T EXPECT,經歷了致命的嚴重不良事件,與CRS 和免疫效應細胞相關的神經毒性症候群。
This patient autopsy showed no histological evidence of his lymphoma despite the fact that there were two large tumor masses present prior to treatment with only eight oh eight. As a result, as a result of this unfortunate events and in alignment with the FDA, we decided to implement additional protocol changes that include modified eligibility criteria, additional screening for adult infection and testing lower doses of AMP eight oh eight. We believe these changes will help us further ensure patient safety as we investigate the optimal dose of AMP eight away for patients with advanced B-cell lymphoma, including patients who have relapsed after CD19 CAR T treatments, we expect to report updated clinical results, including from this new dosing schedule for AMP eight oh eight in mid 2024.
儘管在僅用八或八進行治療之前存在兩個大腫瘤塊,但該患者屍檢未顯示其淋巴瘤的組織學證據。因此,由於這一不幸事件,並與 FDA 保持一致,我們決定實施額外的方案變更,包括修改資格標準、對成人感染進行額外篩檢以及測試較低劑量的 AMP 8 oh 8。我們相信這些變化將幫助我們進一步確保患者安全,因為我們正在調查晚期 B 細胞淋巴瘤患者(包括 CD19 CAR T 治療後復發的患者)的 AMP 最佳劑量八遠,我們期望報告更新的臨床結果,包括根據2024 年中期AMP 八點八點的新給藥時間表。
Overall, our two clinical programs on five three four and on eight oh eight are advancing, and we are looking forward to potential significant value inflection points for the Company from both programs in the near term. With this, I now turn the call over to our CFO, Rich Vincent.
總體而言,我們的五三四和八八八的兩個臨床項目正在推進,我們期待這兩個項目在短期內為公司帶來潛在的重大價值轉折點。現在,我將電話轉給我們的財務長 Rich Vincent。
Richard Vincent - CFO
Richard Vincent - CFO
Yes, Brett, thank you, Jim. Our revenue is currently derived from research and development grants received from the NIH. Our grant revenue was $0.3 million for the fourth quarter ended December 31st, 2023 and $0.8 million for the full year 2023. Our total operating expenses for the fourth quarter were $9.9 million, which included $2.2 million in non-cash stock based compensation expense. Full operating expenses for the full year were $42.5 million, which included $7.5 million and non-cash stock-based compensation expense. In the fourth quarter, research and development expenses totaled $6.7 million and general and administrative expenses totaled $3.2 million for the full year.
是的,布雷特,謝謝你,吉姆。我們目前的收入來自美國國立衛生研究院 (NIH) 的研發資助。截至 2023 年 12 月 31 日的第四季度,我們的贈款收入為 30 萬美元,2023 年全年的贈款收入為 80 萬美元。我們第四季的總營運費用為 990 萬美元,其中包括 220 萬美元的非現金股票補償費用。全年全部營運費用為 4,250 萬美元,其中包括 750 萬美元和非現金股票補償費用。第四季度,全年研發費用總計 670 萬美元,一般及管理費用總計 320 萬美元。
Research and development expenses totaled $29.8 million, and general and administrative expenses totaled $12.7 million. Net loss for the fourth quarter was $9.2 million for a loss of $3 and $0.11 per share basic and diluted. For the full year, our net loss was $39.5 million for a loss of 13.4 or three per share, basic and diluted. As of December 31st, 2023, we had 2.9 million shares common stock outstanding with $34.3 million in cash, cash equivalents and short-term investments and no debt. We believe these funds will be sufficient to fund our operations into the first quarter of 2025.
研究與開發費用總計 2,980 萬美元,一般及管理費用總計 1,270 萬美元。第四季淨虧損為 920 萬美元,每股基本虧損和攤薄虧損分別為 3 美元和 0.11 美元。全年淨虧損為 3,950 萬美元,每股虧損 13.4 美元或 3 美元(基本和稀釋後)。截至 2023 年 12 月 31 日,我們擁有 290 萬股已發行普通股,現金、現金等價物及短期投資為 3,430 萬美元,無負債。我們相信這些資金將足以為我們 2025 年第一季的營運提供資金。
With respect to upcoming milestones, we remain on track from five 34 our lead dairy product candidate. We expect to present initial clinical data late in the second quarter of 2024 with additional data readouts in the fourth quarter of 2020 from A. to ATRO. one autologous CAR T. We expect to report a clinical data update mid 2024 with additional data readouts in the fourth quarter of 2020. For now, I will turn the call back over to Jim.
就即將到來的里程碑而言,我們的領先乳製品候選產品 5 34 仍處於正軌。我們預計將在 2024 年第二季末提供初步臨床數據,並在 2020 年第四季從 A. 到 ATRO 讀取更多數據。 1 個自體 CAR T。我們預計將在 2024 年中期報告臨床數據更新,並在 2020 年第四季公佈更多數據。現在,我將把電話轉回吉姆。
Jim Breitmeyer - President and CEO
Jim Breitmeyer - President and CEO
Yes. Thanks, Rich. So with that, I think we are ready to take questions. Alicia, if you could see ask open up the floor for questions.
是的。謝謝,里奇。因此,我想我們已經準備好回答問題了。艾莉西亞,如果你能看到請開放提問。
Operator
Operator
(Operator Instructions) Carl Byrnes, Northland Capital Markets.
(操作員說明)Carl Byrnes,Northland Capital Markets。
Carl Byrnes - Analyst
Carl Byrnes - Analyst
Thanks for the question and congratulations on your progress. I was just wondering if when you have the update in the late second quarter on program five 34 is that going to be data through the one 60 milligram dose? And then when would you expect to begin dosing the 300 milligram cohort? And then I have a follow-up as well, please?
感謝您的提問並祝賀您的進步。我只是想知道,當您在第二季末更新第 5 號計劃 34 時,是否會得到 60 毫克劑量的數據?那麼您預計什麼時候開始服用 300 毫克的劑量?然後我還有後續行動,好嗎?
Jim Breitmeyer - President and CEO
Jim Breitmeyer - President and CEO
Sure, Karl. Thank you for the question. So as you know, of course, progress of clinical trials is difficult to predict with accuracy, but we are we are hopeful that we'll be able to be speaking about both the 160 milligram dose and the 300 milligram dose at the by the end of the second quarter.
當然,卡爾。感謝你的提問。當然,如您所知,臨床試驗的進展很難準確預測,但我們希望最終能夠談論 160 毫克劑量和 300 毫克劑量第二季度。
Carl Byrnes - Analyst
Carl Byrnes - Analyst
Oh, great. That's very helpful. And then moving over to A2A. In terms of the specifics of eligibility criteria, you mentioned screening for infection and then also the new dosing schedule. Have you have you provided an update on what that new dosing schedule is? Obviously it's going to be priced somewhere significantly below one to the power of 10 to six. Is that like are starting at like 0.25 and then escalating from there.
哦,太好了。這非常有幫助。然後轉向A2A。就資格標準的具體情況而言,您提到了感染篩檢以及新的給藥方案。您是否提供了新的給藥方案的最新情況?顯然,它的定價將遠低於 1 的 10 的 6 次方。是從 0.25 開始,然後從那裡逐步升級?
Jim Breitmeyer - President and CEO
Jim Breitmeyer - President and CEO
Thanks. Thank you, Carl. And that's that's exactly right. And the gasoline, do you want to you want to discuss a new dosing schedule? Sure. So called the dosing schedule, we'll start with 0.3 times 10 to the six, and then the next dose level will be 0.6 times 10 to the six and then will be one. And then based on the results, the SRC can decide if they want to do anything between one and three and because we haven't SRC's, it's actually making. So so dosing decision. And the SRC is the PI.'s who are enrolling in the study as well as an independent academic physician who was treating patients was CAR-T and company physicians.
謝謝。謝謝你,卡爾。這是完全正確的。至於汽油,您想討論新的劑量安排嗎?當然。所謂的給藥方案,我們將從 0.3 乘以 10 的六倍開始,然後下一個劑量水平將為 0.6 乘以 10 的六倍,然後是 1。然後根據結果,SRC 可以決定他們是否想做 1 到 3 之間的任何事情,因為我們沒有 SRC,所以它實際上正在製作。如此劑量決定。SRC 是參與研究的 PI,以及治療 CAR-T 患者的獨立學術醫生和公司醫生。
Carl Byrnes - Analyst
Carl Byrnes - Analyst
Great. Perfect. Thank you. That's very helpful.
偉大的。完美的。謝謝。這非常有幫助。
Sure.
當然。
Operator
Operator
Hartaj Singh, Oppenheimer.
哈塔吉·辛格,奧本海默。
Hartaj Singh - Analyst
Hartaj Singh - Analyst
Great. Thank you. Thank you for the questions. I have got a couple of one is maybe to just dig in a little bit to the questions earlier about long term five, three, four in some calls, we've done with key opinion leaders. They have indicated that there's a high unmet need for such a mechanism of action in the area of metastatic castrate resistant prostate cancer arm. You, Richard, if you can just kind of give us an idea of what that market size looks like, you know, and what would be the TAM potentially even you know, in terms of pricing because there is an genericization in the market? Just any thoughts there? And I got a couple of quick follow-ups.
偉大的。謝謝。謝謝你的提問。我有幾個可能只是在一些電話會議中深入探討有關長期五、三、四的問題,我們已經與關鍵意見領袖進行了交談。他們指出,在轉移性去勢抵抗性前列腺癌領域,對這種作用機制的需求尚未被滿足。你,理查德,如果你能給我們一個關於市場規模的想法,你知道,甚至你也知道,在定價方面,TAM 可能是多少,因為市場上有通用化?只是有什麼想法嗎?我得到了一些快速的跟進。
Jim Breitmeyer - President and CEO
Jim Breitmeyer - President and CEO
Sure, Hartaj, thanks. Thank you for the question. So so there's there's two we've been penciling in two different market sizing options. The first would be if we if it is a drug that is used in patients who are who have failed, who have metastatic disease and have failed and available one or more available androgen receptor pathway inhibitors. And and we do believe that there is a potential for a sales potential of $1 billion or near near 1 billion.
當然,哈塔傑,謝謝。感謝你的提問。因此,我們已經在兩個不同的市場規模選項中列出了兩個。第一個是,如果它是一種藥物,用於失敗的患者、患有轉移性疾病且失敗的患者,並且可以使用一種或多種可用的雄激素受體途徑抑制劑。我們確實相信,銷售潛力有可能達到 10 億美元或接近 10 億美元。
But as you know, unlike some other drugs that are in development and are focused on mutations of the androgen receptor on five three four is also very active against cancers expressing the native androgen receptor. So that means that it has the potential to move into earlier lines of therapy such as hormone-sensitive prostate cancer. And so as you can imagine with that kind of indication, the and there's an multibillion dollar potential.
但如您所知,與其他正在開發的、專注於五三四雄激素受體突變的藥物不同,它對錶達天然雄激素受體的癌症也非常活躍。因此,這意味著它有可能進入早期治療領域,例如荷爾蒙敏感型前列腺癌。因此,正如您可以想像的那樣,有數十億美元的潛力。
Carl Byrnes - Analyst
Carl Byrnes - Analyst
Yes, Jim, that's very, very helpful. And then the other question is just going back to eight oh eight. I know that the last time we had talked on our health care conference actually just a few weeks ago. The Oppenheimer Healthcare Conference, you had indicated that you're getting the amendments to IRBs of. When could we start seeing patients being included into the NOVA trial? I know you've already set the time lines for the next data updates, but just any thoughts there?
是的,吉姆,這非常非常有幫助。然後另一個問題就是回到八點八點。我知道我們上次討論醫療保健會議實際上是在幾週前。在奧本海默醫療保健會議上,您曾表示您正在收到 IRB 的修正案。我們什麼時候可以開始看到患者被納入 NOVA 試驗?我知道您已經設定了下一次資料更新的時間線,但有什麼想法嗎?
Jim Breitmeyer - President and CEO
Jim Breitmeyer - President and CEO
Absolutely. So we are we're very encouraged that our Triage, our treating physicians, our principal investigators are very eager to get patients into the study. And in fact, several patients have been identified with that that the investigators want to get on the study. And so they are doing everything that they can at their sites to expedite the approval of the amended study so that their patients can be treated. So we're optimistic that it's not going to take two.
絕對地。因此,我們的分診、我們的治療醫生、我們的主要研究人員都非常渴望讓患者參與這項研究,這讓我們感到非常鼓舞。事實上,已經有幾名患者被認定為研究人員希望參與研究的患者。因此,他們正在現場盡一切努力加快修改後的研究的批准,以便他們的患者能夠得到治療。所以我們樂觀地認為這不需要兩個人。
Carl Byrnes - Analyst
Carl Byrnes - Analyst
Great. Thank you, Jim. And then last question is just looking at your OpEx burn, you Richard came in a pretty decent bit, 10% below what we were expecting in the fourth quarter generally tends to be a little on the heavy side, and you've already given your guidance for your cash runway into next year. But just what are the reasons that your R&D was, you know, it seems to be almost $1 million less than what we were expecting. Then, is that the way to think about it sort of going forward.
偉大的。謝謝你,吉姆。最後一個問題是看看你的營運支出消耗,理查德的表現相當不錯,比我們第四季度的預期低 10%,一般來說有點偏重,而且你已經給了你的為您明年的現金跑道提供指導。但到底是什麼原因,你們的研發費用似乎比我們的預期少了將近 100 萬美元。那麼,這是思考未來發展的方式嗎?
Jim Breitmeyer - President and CEO
Jim Breitmeyer - President and CEO
Also, we believe that the primary reason that the fourth quarter came in under it is because we were wrapping up the Zillow three oh one program and we actually did that very efficiently earlier than planned. And we brought a lot of the work in-house kind of in the Q3 timeframe, and we were able to keep those costs down very significantly compared to what the original forecasts look like. So I think the majority of the delivery of one costs are clearly behind us, and that's really holds true for a good chunk of the Zila program costs, even for the Phase one two study, we're really winding that down and treating the last patients there earlier this year started originally with the 9 to 10 million cash burn per quarter be realistic basically through the next few quarters. So keep in mind that the nine to $10 million included roughly two plus million of non cash stock-based compensation expense. So it's closer to the 7.5 to kind of $99 million range as enrollment picks up.
此外,我們認為第四季度進入這一階段的主要原因是我們正在結束 Zillow 三對一計劃,而且我們實際上比計劃提前完成了這項工作,非常有效率。我們在第三季的時間範圍內進行了大量內部工作,與最初的預測相比,我們能夠大幅降低這些成本。因此,我認為一項成本的大部分交付顯然已經過去了,這對於Zila 計劃成本的很大一部分來說確實如此,即使對於第一階段和第二階段的研究,我們也確實正在逐步減少並處理最後一項成本今年早些時候,那裡的患者最初開始每季燒錢 900 至 1000 萬美元,但在接下來的幾個季度中,基本上是現實的。因此請記住,900 到 1000 萬美元包括大約 200 萬美元的非現金股票補償費用。因此,隨著入學人數的增加,它更接近 750 至 9900 萬美元的範圍。
Carl Byrnes - Analyst
Carl Byrnes - Analyst
Yes. Great. Thank you, Jim, and thank you, Rich. Thanks for all the questions.
是的。偉大的。謝謝你,吉姆,謝謝你,里奇。感謝您提出所有問題。
Jim Breitmeyer - President and CEO
Jim Breitmeyer - President and CEO
Thank you, Hartaj.
謝謝你,哈塔傑。
Operator
Operator
Kemp Dolliver, Brookline Capital Markets.
Kemp Dolliver,布魯克林資本市場。
Kemp Dolliver - Analyst
Kemp Dolliver - Analyst
Yes, great. Thank you. A couple of questions regarding oh eight. So just to be clear on how the program will proceed. So you've dosed three patients at the one times 10 to the six dose, you're going to go down to the first dose cohort and then move up the stack. And it sounds like you will dose the initial dose a second time such that if you do three patients each, will you potentially at a minimum would have 12, 12 patients before deciding whether you should go up to a higher dose?
對,很好。謝謝。關於八號的幾個問題。所以只是為了弄清楚該計劃將如何進行。因此,您已經給三名患者服用了一次 10 到 6 劑的劑量,您將進入第一個劑量組,然後向上移動。聽起來您將第二次服用初始劑量,這樣,如果您每次對 3 名患者進行治療,那麼在決定是否應該提高劑量之前,您是否至少會接受 12、12 名患者?
Richard Vincent - CFO
Richard Vincent - CFO
Yes, so I mean, actually, this is why I said earlier, we will evaluate the 0.3 times 10 to the six from 0.6, which is the two new cohort that we added first before we decide if we want if we want to go again into one or we want to do intermediate dose above one and between one and three and that will be decided by the SRC, as I said earlier, because as you know, the one was well tolerated and we moved into the next cohort. So I think based on what we can see from 0.3 and 0.6, that will be decided if we get to add more patients into one or two and intermediate dose between one and three.
是的,所以我的意思是,實際上,這就是為什麼我之前說,我們將從0.6乘以10到6來評估0.3,這是我們在決定是否要再去之前首先添加的兩個新隊列正如我之前所說,我們想要進行1 次以上、1 到3 次之間的中間劑量,這將由SRC 決定,因為如您所知,該劑量耐受性良好,我們進入了下一組。因此,我認為根據我們從 0.3 和 0.6 中看到的情況,我們將決定是否將更多患者添加到一到兩個劑量以及一到三個之間的中間劑量。
Okay. And what's the reason for potentially dosing at the one one at one again, is it because the protocol changes significant enough that the data wouldn't be comparable No. And that's why I said the SRC will meet and will decide. And the only reason probably would be there if we start seeing some toxicity at 0.6 and then we will may want to add more patients into one. I mean, I think there's multiple reason to do that. But I mean, I cannot predict what we're going to see but it's always going to be depending on what the data will tell us from the two new cohorts.
好的。可能再次進行一對一給藥的原因是什麼,是因為方案變化足夠大,以至於數據無法比較嗎?這就是為什麼我說 SRC 將召開會議並做出決定。唯一的原因可能是,如果我們在 0.6 時開始看到一些毒性,然後我們可能會想要將更多患者添加到其中。我的意思是,我認為這樣做有幾個原因。但我的意思是,我無法預測我們會看到什麼,但這總是取決於這兩個新群體的數據告訴我們什麼。
Kemp Dolliver - Analyst
Kemp Dolliver - Analyst
Okay, that's fine. And with regard to the approvals that are remaining or you're waiting, have IRB approvals or are there or FDA?
好吧,沒關係。至於剩餘的或正在等待的批准,是否有 IRB 批准或 FDA 批准?
Richard Vincent - CFO
Richard Vincent - CFO
No, we have actually get agreement with the FDA about the protocol changes and actually everything's was submitted to the IRB and we just we think some of the logistical things that decide to be done a lot to last seems to be a while before before we initiate the enrollment again.
不,我們實際上已經與 FDA 就協議變更達成一致,實際上所有內容都已提交給 IRB,我們只是認為一些決定要持續進行的後勤工作似乎需要一段時間才能開始再次報名。
Kemp Dolliver - Analyst
Kemp Dolliver - Analyst
Okay. Got it. And Richard, it sounds like there will be a small amount of expenses for resolver at I-Mab in 24, but we're probably talking about a six digit number or less is that a fair assumption? Rich, that's close.
好的。知道了。Richard,聽起來 24 年內天境生物的解析器會有少量費用,但我們可能會討論的是六位數或更少,這是一個合理的假設嗎?豐富,已經很接近了。
Great. Thank you. Thank you, Kemp.
偉大的。謝謝。謝謝你,坎普。
Jim Breitmeyer - President and CEO
Jim Breitmeyer - President and CEO
Thank you.
謝謝。
Operator
Operator
Since you there are no further questions at this time, I'd like to turn the floor back over to Dr. Jim Breitmeyer for closing remarks.
由於目前沒有其他問題,我想將發言權交還給 Jim Breitmeyer 博士作結束語。
Jim Breitmeyer - President and CEO
Jim Breitmeyer - President and CEO
Thank you, Alicia. And we continue to advance our two clinical programs towards significant clinical data inflection points by midyear. While we are reiterating our cash runway guidance into 2025. We are excited to be advancing the clinical development of novel pathways in areas with very high unmet medical need. Specifically, patients with metastatic castrate resistant prostate cancer harboring androgen receptor mutations and splice variants and patients with aggressive B-cell lymphoma who are relapse refractory or unable to obtain CD19 CAR T therapy. With that thank you for joining us today, and we look forward to updating you throughout the year. Alicia?
謝謝你,艾莉西亞。我們將繼續推進我們的兩個臨床項目,以期在年中之前實現重要的臨床數據拐點。同時,我們也重申了 2025 年的現金跑道指引。我們很高興能夠在醫療需求未被滿足的領域中推進新途徑的臨床開發。具體來說,患有雄性激素受體突變和剪接變異的轉移性去勢抵抗性前列腺癌患者,以及復發難治或無法獲得 CD19 CAR T 治療的侵襲性 B 細胞淋巴瘤患者。感謝您今天加入我們,我們期待全年為您提供最新資訊。艾麗西亞?
Operator
Operator
Thank you. This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.
謝謝。今天的電話會議到此結束。此時您可以斷開線路。感謝您的參與。