Q4 2023 Oncternal Therapeutics Inc Earnings Call
Operator: Greetings and welcome to Oncternal's fourth quarter 2023 financial results. At this time, all participants are in a listen only mode.
Greetings and welcome to on Turtles 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. If anyone should require operator assistance during the conference. Please press star.
Operator: A brief question-and-answer session will follow the formal presentation. If anyone should require the operator's assistance during the, please press star zero on your telephone. As a reminder, this conference is being held. It is now my pleasure to introduce your host, Richard Vincent, Chief Financial Officer. Thank you, Richard. You may be disconnected.
Zero on your telephone keypad 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.
Richard Vincent: 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. R10K 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 Oncternal's 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. 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.
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 Reitmeier, and our CMO, Dr. Saline Y'all Street.
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 amongst Arnold's 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.
We will be making forward looking statements during this call about future events, such as our business and product development strategies.
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.
Richard Vincent: 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 31, 2023, as filed today. This call contains time-sensitive information that is accurate only as of the date of this live broadcast, March 7, 2024. We undertake no obligation to revise or update any forward-looking statements to reflect events or circumstances occurring after the date of this call.
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.
Our Form 10-K for the full year ended December 31, 2023 as filed today.
This call contains time sensitive information that is accurate only as of the date at this live broadcast March seven 2024.
We undertake no obligation to revise or update any forward looking statements to reflect events or circumstances occurring after the date of this call.
Richard Vincent: With that, it is my pleasure to hand the call over to our CEO, Dr. Jim Breitmeyer. Thank you, Rich. And good afternoon, everyone.
With that it is my pleasure to hand, the call over to our CEO Dr. Jim Meyer.
Thank you rich and good afternoon, everyone.
James B. Breitmeyer: At Oncternal, we are advancing two first-in-class clinical programs targeting cancers for patients with significant unmet medical needs. We continue to be excited about the potential of Onct 534 and its novel mechanism of action, which may address a significant unmet need for advanced prostate cancer patients who progress after currently approved AR pathway inhibitor therapy and before they move into more aggressive treatment options such as chemotherapy or radioligand therapy. Earlier this year, we announced that four patients with metastatic castrate-resistant prostate cancer had been enrolled into our Phase 1-2 dose escalation dose expansion study of Onct 534. We have been able to dose-escalate as planned without unexpected dose-limiting toxicities, and the third dosing cohort of 160 mg of ONC534 is now fully enrolled.
I'll turn all we are advancing two first in class clinical programs targeting cancers for patients with significant unmet medical needs. We continue to be excited about the potential of 534 and its novel mechanism of action, which may address a significant unmet need for advanced prostate cancer patients.
Who progressed after currently approved <unk> pathway inhibitor therapy.
And before they move into more aggressive treatment options, such as chemotherapy or radio ligand therapy.
Earlier this year, we announced that for patients with metastatic castrate resistant prostate cancer have been enrolled into our phase <unk> dose escalation dose expansion study of occupying three four.
We have been able to dose escalate as planned without unexpected dose limiting toxicities and the third dosing cohort of 160.
60 milligrams.
Hmm.
Three four is now fully enrolled.
James B. Breitmeyer: We plan to announce an initial clinical data update for this program late next quarter. With respect to Onct 808, our ROR1 targeting autologous CAR T, we released initial clinical data in December from a Phase 1-2 study of Onct 808-101 in patients with relapsed or refractory aggressive B-cell lymphoma, including patients who have failed previous CD19 CAR T therapy. We saw an encouraging response signal at the initial dose of 1 times 10 to the 6th CAR-T cells per kilogram, with two of the three patients achieving complete metabolic responses, and the third achieving a partial response as of the December 4th cutoff date. Common adverse events in this dosing cohort included decreased blood counts, pneumonia, and grade 1-2 cytokine release syndrome or CRS. The first patient treated at the dose level of 3 times 10 to the 6th CAR-T cells per kilogram, an 80-year-old with bulky disease who had received four previous lines of therapy, including CD19 CAR-T, experienced a fatal serious adverse event consistent with CRS and immune effector cell-associated neurotoxicity syndrome. This patient's autopsy showed no histological evidence of his lymphoma, despite the fact that there were two large tumor masses present prior to treatment with Onc 808.
We plan to announce an initial clinical data update from this program late next quarter.
With respect to 808 are Rowan targeting autologous car T. We released initial clinical data in December from Phase one two study.
Eight Oh wait 101 in patients with relapsed or refractory aggressive b cell lymphoma.
Including patients who have failed previous CD 19 car T therapy.
We saw an encouraging response signal at the initial dose of one times 10 to the sixth 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 4th cutoff date common adverse events in this dosing cohort included decreased blood.
Counts pneumonia in grade one to cytokine release syndrome or Crs.
The first patient treated at dose level of three times 10 to the six car T cells per kilogram and 80 year old with bulky disease, who had received four probably previous lines of therapy, including CD 19 car T.
Expect experienced a fatal serious adverse events consistent with Crs and immune effector cell associated neurotoxicity syndrome.
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 an ate away.
James B. Breitmeyer: As a result of this unfortunate event, 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 Onc808. We believe these changes will help us further ensure patient safety as we investigate the optimal dose of OCT-808 for patients with advanced B-cell lymphoma, including patients who have relapsed after CD19 CAR-T treatment. We expect to report updated clinical results, including from this new dosing schedule for ONC-808, in mid-2024. Overall, our two clinical programs, ONC 534 and ONC 808, are advancing, and we are looking forward to potential significant value inflection points for the company from both programs in the near term. With that, I now turn the call over to our CFO, Rich Vincent. Brett
As a result as a result of this unfortunate event 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 eight Oh wait.
We believe these changes will help us further ensure patient safety as we investigate the optimal dose of <unk> eight Oh wait for patients with advanced B cell lymphoma, including patients who have relapsed after CD 19 car T treatment.
We expect to report updated clinical results, including from this new dosing schedule for 808 in mid 2024.
Overall, our two clinical programs arc 534, and 808 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.
Rich.
Richard Vincent: Thank you, Jim. Our revenue is currently derived from research and development grants received from the National Institutes of Health. Our grant revenue was $0.3 million for the fourth quarter ended December 31, 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 expenses. Full operating expenses for the full year were $42.5 million, which included $7.5 million in non-cash, stock-based compensation expenses.
Thank you Jim.
Our revenue is currently derived from research and development grants received from the NIH.
Our grant revenue was <unk> 3 million for the fourth quarter ended December 31, 2023, and <unk> 8 million for the full year 2023.
Our total operating expenses for the fourth quarter were $9 9 million, which included $2 2 million and noncash stock based compensation expense.
Total operating expenses for the full year were $42 5 million, which included $7 5 million in noncash stock based compensation expense.
Richard Vincent: 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, research and development expenses totaled $29.8 million, and general and administrative expenses totaled $12.7 million. The net loss for the fourth quarter was $9.2 million, for a loss of $3.11 per share, basic and diluted. For the full year, our net loss was $39.5 million, for a loss of $13.43 per share, basic and diluted.
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 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 11 per share basic and diluted.
For the full year, our net loss was $39 5 million for a loss of $13 43 per share basic and diluted.
Richard Vincent: As of December 31, 2023, we had 2.9 million shares of 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. With respect to upcoming milestones, we remain on track. For Onct 534, our lead DARI 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 2024. For ARMC808, or ROR1 Autologous CAR-T, we expect to report a clinical data update in mid-2024, with additional data readouts in the fourth quarter of 2024.
As of December 31, 2023, we had $2 9 million shares of 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.
With respect to upcoming milestones we remain on track.
On slide 34, our lead 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 2024.
<unk> 808, our <unk> autologous car T. We expect to report a clinical data update mid 2024 with additional data readouts in the fourth quarter of 2024.
Now I will turn the call back over to Jim.
Thanks, Rich so with that I think we are ready to take questions. Alicia if you could.
James B. Breitmeyer: Now, I will turn the call back over to Jim. Thanks, Rich. So, with that, I think we are ready to take questions. Alicia, could you open up the floor to questions?
Open up the floor for questions.
Of course.
We will now be conducting a question and answer session. If you would like to ask a question. Please press star one on your telephone keypad.
A confirmation tone will indicate your line is in the question queue.
You May press star two if he would like to remove your question from the queue for participants using speaker equipment. It may be necessary to pick up your handset before pressing the star keys.
One moment, please while we poll for questions.
Thank you.
First question comes from the line of Carl Byrnes with Northland Capital markets. Please proceed with your question.
Thanks for the question and congratulations on your progress I was just wondering if when.
Operator: We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone. The Confirmation Tool will indicate your line is busy.
When you have the update in the late second quarter on an program 534 is that going to be data three to $1 60 milligram dose and then when would you expect to begin dosing the 300.
Operator: You may press star 2 if you would like to remove your question. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the start button. One moment, please, while we pull for questions. Thanks. Our first question comes from the line of Carl Byrnes with Northland Capital. Please proceed with your call. 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 534, is that going to be done through the 160 milligram dose? And then when would you expect to begin dosing the 300 milligram cohort? And then I have a follow-up as well. Sure, Carl.
Milligram cohort and then I have a follow up to some opex.
Sure Carl Thank you for the question so.
Of course progress of clinical trials is.
Difficult to predict with accuracy, but where we are hopeful that we'll be able to we'll be speaking about both the 160 milligram dose and the 300 milligram dose.
By the end of the second quarter Oh, Great. That's very helpful. And then moving over to 808 in terms of the specifics of eligibility criteria. I know 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.
James B. Breitmeyer: Thank you for the question. So, you know, of course, progress in clinical trials is difficult to predict with accuracy, but we are hopeful that we'll be able to speak about both the 160 milligram dose and the 300 milligram dose by the end of the second quarter. Oh, great. That's very helpful.
Somewhere below one to the power of $10 six is that like starting at like point to five and then escalating from there. Thanks.
Thank you Karl and that's that's exactly right.
Selim do you want to you want to discuss the new dosing schedule.
Sure So Carlos the dosing schedule will start with 0.3 times 10 to the six and then the next dose level would it be 0.6 times 10 to the six and then.
James B. Breitmeyer: And then moving over to 808, in terms of the specifics of eligibility criteria, I know you mentioned screening for infection and then also the new dosing schedule. Have you provided an update on what that new dosing schedule is? Obviously, it's going to be somewhere significantly below one to the power of 10 to six.
Would be one and then based on the results.
So you can decide if they want to do anything between one and three and because we havent src's, that's actually making so so.
Dosing decision and then I saw she is.
<unk>, who are enrolling in the study as well as an independent.
They make a physician who is treating patients with car T and company physicians.
Great perfect. Thank you that's very helpful.
Sure.
Yeah.
Thank you. Our next question comes from the line of hard hard thing with Oppenheimer. Please proceed with your question.
James B. Breitmeyer: Is that like starting at like point 25 and then escalating from there? Thanks. Thank you, Carl. And that's exactly right.
Oh, great. Thank you. Thank you for the questions I, just I've got a couple.
One is maybe to just dig into a little bit to the questions earlier about long term.
Salim Yazji: Salim, do you want to discuss the new dosing schedule? Sure. So Carl, the dosing schedule will start with 0.3 times 10 to the 6th, and then the next dose level will be 0.6 times 10 to the 6th. And then, you know, there 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 have an SRC that's actually making those.
534 in <unk>.
Some calls we've done with key opinion leaders, David indicated that there's a high unmet need for such a mechanism of action.
In the area of metastatic castrate resistant prostate cancer.
Richard If you can just kind of give us an idea of what that market size looks like.
And what would be the time potentially even you know in terms of pricing because there is some generic position in the market just any thoughts there and I got a couple of quick follow ups.
Salim Yazji: Dosing Decision, and the SRC is the PIs who are enrolling in the study, as well as an independent academic physician who's treating patients with SCAR-T and company. Great. Perfect. Thank you. That's very helpful. True.
Sure sure Hi, Josh. Thank you for the question. So so there is there is too.
We've been penciling in two different market sizing options the first would be it.
James B. Breitmeyer: Thank you. Our next question comes from the line of Hartaj Singh with Oppenheimer. Please proceed with your questions. Great. Thank you. Thank you for the questions. I've got a couple.
If we if it is a drug that is used in patients who are who have failed who had metastatic disease and have failed.
James B. Breitmeyer: One is maybe to just dig in a little bit to the questions earlier about Onct 534. You know, in some calls we've done with key opinion leaders, they've indicated that, you know, there's a high unmet need for such a mechanism of action in the area of metastatic castrate-resistant prostate cancer. You know, Richard, if you can just kind of give us an idea of what that market size looks like, you know, and what the time, potentially, even, you know, in terms of pricing, because there is some genericization in the market. Any thoughts there?
And available one or more available androgen receptor pathway inhibitors.
And we.
We do believe that there is a potential for a sale.
Sales potential of $1 billion or near near $1 billion.
But as you know unlike some other drugs that are in development and are focused on mutations of the androgen receptor. On 534 is also very active against <unk>.
James B. Breitmeyer: And I got a couple of quick follow-ups. Sure. Sure, Hartaj.
James B. Breitmeyer: Thank you for the question. So, there are two. We've been penciling in two different market sizing options. The first would be if, if we, if it is a drug that is used in patients who are, who have failed, who have metastatic disease and have failed one or more available androgen receptor pathway inhibitors. And we do believe that there is a potential for a sales potential of a billion dollars or near-near $1 billion. But as you know, unlike some other drugs that are in development and are focused on mutations of the androgen receptor, Onct 534 is also very active against cancers expressing the native androgen receptor.
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 with that kind of.
Indication.
There is a multibillion dollar potential.
Yes, Jim that's very very helpful.
And then the other question is just going back to 808 I know that the.
The last time, we had talked on our health care Conference I should just a few weeks ago. The Oppenheimer Healthcare Conference. You had indicated that you are getting the amendments why arby's.
When could we start seeing patients being included into the <unk> trial I know you've already set the timelines for the next data updates, but just any thoughts there.
James B. Breitmeyer: 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, there's a multi-billion dollar potential. Yep, Jim, that's very, very helpful. And then, you know, the other question is just going back to 808.
Absolutely so so.
We are we were we're very encouraged.
R R.
Our treating physicians are principal investigators are very eager.
Two to get patients into the study and in fact several patients have been identified.
James B. Breitmeyer: I know that the last time we talked at our healthcare conference, actually, just a few weeks ago, the Oppenheimer Healthcare Conference, you had indicated that you were getting the amendments to the IRBs. When could we start seeing patients being recruited into the 808 trial? I know you've already set the timelines for the next data updates, but just any thoughts there? Absolutely.
That that the investigators wanted to get on the study and so they are doing everything that they cannot their sites to expedite the approval of the amended study says that their patients can be treated.
So we were optimistic that theres not going to take too long.
Great. Thank you Jim and then last question is just you know just looking at your Opex burn.
James B. Breitmeyer: So we're very encouraged that our treating physicians, our principal investigators, are very eager to get patients into the study. And in fact, several patients have been identified 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 too long. Great, great. Thank you, Jim. And then last question is, you know, just looking at your OpEx burn, you came in pretty decent bit, 10% below what we were expecting. I know the fourth quarter generally tends to be a little on the heavy side.
Yeah, Richard came in pretty decent bet, 10% below what we were expecting I know the fourth quarter generally tends to be a little help 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 and then.
Is that the way to think about it going forward also.
Okay.
We believe that the primary reason that the fourth quarter came in under is because we were wrapping up the Zillow 301 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.
Richard Vincent: And you've already given your guidance for your cash runway into next year. But just what are the reasons that your R&D seems to be almost a million dollars less than what we were expecting? And then is that the way to think about it sort of going forward also? We believe that the primary reason that the fourth quarter came in under budget was because we were wrapping up the Zillow 301 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 forecast looked like.
Costs down very significantly.
Compared to.
What the original forecast look like.
So I think that.
You already have is still a 301 costs are clearly behind us and that's really holds true for a good chunk of the Zillow program costs, even for the phase one two study.
We're really winding that down.
And trading the last patients there earlier this year.
Got it right. So I mean with the $9 million to $10 million cash burn per quarter would be realistic basically through.
Richard Vincent: So, I think the majority of the Zillow 301 costs are clearly behind us, and that really holds true for a good chunk of the Zillow program costs, even for the Phase 1-2 study. We're really winding that down and treating the last patients there earlier this year. Got it. So, would the nine to 10 million, you know, cash burn per quarter be realistic, basically, through the next few quarters? Well, keep in mind that the nine to ten million included roughly two plus million of non-cash stock-based compensation expense.
Through the next few quarters.
Well keep in mind that the $9 million to $10 million included roughly two plus million of non cash stock based compensation expense. So it's.
What sort of the seven and a half to kind of $99 million range as enrolled.
Enrollment picks up.
Great. Thank you Jim Thank you rich thanks for all the questions.
Thank you Josh.
Thank you. Our next question comes from the line of Ken <unk> with Brookline Capital markets. Please proceed with your question.
Great. Thank you.
Couple of questions regarding <unk>.
So.
Just to be clear on how the.
Program will proceed so you've dosed three patients.
Richard Vincent: So it's closer to the seven and a half million dollars to kind of nine million dollar range as enrollment picks up. Thank you, Jim. Thank you, Rich. Thank you, Hartaj. Thank you. Our next question comes from the line of Kent Dolliver with Brookline Capital.
One times 10 to the sixth dose.
Youre going to go down to the.
First dose cohort and then.
Move up to the second and it sounds like you will.
Does the the initial dose a second time such that if you do three patients each evil.
Operator: Please proceed with your call. Great, thank you. A couple of questions regarding 808.
You potentially would have 12.
Operator: So just to be clear on how the program will proceed. So you've dosed three patients at the one times ten to the sixth dose. You're going to go down to the First Dose Cohort, and then we're going to move up to the second, and it sounds like you will... Dose at the initial dose a second time, such that if you do three patients each, you will have, You potentially, at a minimum, would have 12 patients before deciding whether you should go up to a higher dose. Solaine.
12 patients.
Before deciding whether you should go up to a higher dose.
Helane.
Yeah. So I mean actually this is why I said earlier.
We will evaluate the.
0.3 times 10 to the 606, which is the two new cohorts since we added first before we decide if we want if we want to go again into one or we want to do a intermediate dose above.
Above one between one and three.
And that will be decided by the Src as.
As I said earlier, because you know as.
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 the 0.3 and 0.6 that will be decided if we get more patients into one or do an intermediate dose between one and three.
Salim Yazji: Yeah, so I mean, actually, this is why I said earlier, we will evaluate the 0.3 times 10 to the 6 and 0.6, which are the two new cohorts that we added first, before we decide if we want to go again into one, or we want to do an intermediate dose, you know, above one and between one and three. And that will be decided by the SRC, as I said earlier, because, you know, as you know, the first one was well tolerated, and, you know, we moved into the next cohort. So I think based on what we're going to see from the 0.3 and 0.6, it will be decided if we're going to add more patients into one or do an intermediate dose between one and Okay, and what's the reason for that potentially?
Okay, and what's the reason for potentially.
Dosing at one.
One again.
Is it because the protocol changes significant enough to fit the data wouldn't be comparable.
No and that's why I said, the SRT, you would meet and will decide and the only reason probably wouldn't be there if we start seeing some.
Texas, if he had 0.6 and then we wouldn't may want to add more patients into one I mean, I think there's multiple reasons 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.
Salim Yazji: Dosing at one at one again. Is it because the protocol changes are significant enough that the data wouldn't be comparable? No, and that's why I said the SRT would meet and will decide, and the only reason probably will be if we start seeing some toxicity at 0.6, and then we may want to add more patients into one. I mean, I think there are multiple reasons to do that, but I cannot predict what we're going to see, but it's all going to be depending on what the data will tell us from the two numbers.
Okay, that's fine and with regard to the approvals that are remaining are you waiting.
IRB approvals or other.
F D a.
No we have actually got agreements with the FDA about the protocol changes and actually Everything's was submitted to the IRB and we're just waiting some of the logistical things at the site to be done at the last the last things.
Salim Yazji: Okay, that's fine. And with regard to the approvals that are remaining, are you awaiting IRB approvals or FDA approvals? No, we have actually reached agreement with the FDA about the protocol changes, and actually, everything was submitted to the IRB, and we're just waiting for some of the logistical things at the site to be done as the last things to be, you know, before we initiate the enrollment again. Okay, um... Got it. And Richard, it sounds like they're going to be a small amount of expenses for Xyloberta Mab and 24, but we're probably talking about a six digit number or less. Is that a fair assumption?
To be before before we initiate enrollment again.
Okay.
Got it and then.
Richard It sounds like there.
We will be a small amount of expenses or is all of her to mab in 'twenty four but.
We're probably talking about a six digit number or less.
Is that a fair assumption.
Rich.
But that's close.
Okay, great. Thank you.
Alright, Thank you Kim thank.
Thank you.
Thank you there are no further questions at this time I'd like to turn the floor back over to Dr. James Bright Meier for closing remarks.
Thank you Alicia.
We continue to advance our two clinical programs towards significant clinical data inflection points by mid year, while reiterating our cash runway guidance into 2025.
Richard Vincent: Rich, that's close. Okay, great. Thank you. Thank you, Kemp. Thank you. Thank you. There are no further questions at this time. I'd like to turn the floor back over to Dr. James Breitmeyer for closing. Thank you, Alicia. We continue to advance our two clinical programs towards significant clinical data inflection points by mid-year while 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 relapsed, refractory, or unable to obtain CD19 CAR-T therapy.
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 relapsed refractory ore.
Are unable to obtain CD 19 car T therapy.
With that thank you for joining us today, and we look forward to updating you throughout the year.
Alicia.
Thank you. This concludes today's teleconference. You may disconnect. Your lines at this time. Thank you for your participation.
Hello.
No.
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Mhm.
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Oh.
Hmm.
Yeah.
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Hum.
James B. Breitmeyer: With that, thank you for joining us today, and we look forward to updating you throughout the year. Alicia. Thank you. This concludes today's... You may disconnect your lines at this time. Thank you for your participation. Corinne Fay programs wouldn't be in, These are just the things that I know.
Uh huh.
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Yeah.
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Operator: Thank you for tuning in. Richard Vincent, Michael Wang, James Breitmeyer, Salim Yazji, Brian Dolliver, Salim Yazji, Produced by Richard Vincent. Thank you very much for watching!
Yeah.
Yeah.
Okay.
[noise] mhm.
Mhm.