Q1 2024 Oncternal Therapeutics Inc Earnings Call & Business Update
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Operator: Greetings. Welcome to Oncternal's first quarter 2024 financial results. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note, this conference is being recorded. I'll now turn the conference over to you. Richard Vincent, Chief Financial Officer, you may begin.
Greetings and welcome to our internal first quarter 2024 financial results call. At this time, all participants are in a listen only mode.
Operator: A question and answer session will follow the formal presentation. If anyone should require operator assistance on the conference. Please press star zero on your telephone keypad. Please note. This conference is being recorded I will now turn the conference over Geos, Richard Vincent Chief Financial Officer, you May begin.
Richard G. Vincent: Thank you Mollie.
Richard G. Vincent: Good afternoon, everyone. And thank you for joining us today.
Richard G. Vincent: Good afternoon, everyone and thank you for joining us today.
Richard G. Vincent: Joining me on the call. This afternoon are our president and CEO, Dr. James Brian Meyer and our CMO, Dr. Saline Y'alls cheat.
Richard G. Vincent: 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 first quarter ended March 31, 2024 financial results that were filed earlier today. Today's press release and a replay of today's call will be available in 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.
Richard G. Vincent: Thanks.
Richard G. Vincent: All include a business update and discussion of our first quarter ended March 31, 2024 financial results that were filed earlier today.
Richard G. Vincent: Today's press release and a replay of today's call will be available on the Investor Relations section of alternatives website for at least the next 30 days.
Richard G. Vincent: 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 filing.
Richard G. Vincent: 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. However, 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-Q filed today and our previously filed Form 10-K for the full year ended December 31, 2023.
Richard G. Vincent: And our cash runway.
Richard G. Vincent: 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 G. 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-Q filed today and our previously filed Form 10-K for the full year ended December 31 2023.
Richard G. Vincent: This call contains time-sensitive information that is accurate only as of the date of this live broadcast, May 9, 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. With that, it is my pleasure to hand the call over to our CEO, Dr. Jim Breitmeyer.
Richard G. Vincent: This call contains time sensitive information that is accurate only as of the date. That's live broadcast may nine 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.
James B. Breitmeyer: With that it is my pleasure to hand, the call over to our CEO Dr. Jim Reitmeier.
James B. Breitmeyer: Thank you, Rich. And good afternoon, everyone.
James B. Breitmeyer: Thank you rich and good afternoon, everyone.
Speaker Change: And our internal we are advancing two first in class clinical programs targeting cancers for patients with significant unmet medical needs.
James B. Breitmeyer: At Oncternal, we are advancing two first-in-class clinical programs targeting cancers for patients with significant unmet medical needs. OX534, our novel dual-action androgen receptor inhibitor, or DARI, is advancing rapidly through the dose escalation portion of the Phase 1-2 study, and we continue to see high demand and engagement from key opinion leaders, investigators, and patients. We believe that by interacting with both the ligand binding domain and the N-terminal domain of the androgen receptor and by inducing degradation of the AR, ONC534 may address many prostate cancer escape mechanisms to approved AR pathway inhibitors, such as enzalutamide and abiraterone, including many LBD mutations and splice variants, such as ARV7.
James B. Breitmeyer: Five three for our novel dual action androgen receptor inhibitor or diary is advancing rapidly through the dose escalation portion of the phase one two study and we continue to see high demand and engagement from Kols investigators and patients we.
James B. Breitmeyer: We believe that by interacting with both the ligand binding domain and the end terminal domain of the androgen receptor and by inducing degradation of D. A R.
James B. Breitmeyer: Five three for May address many prostate cancer escape mechanisms to approve a pathway inhibitors, such as <unk> and abiraterone, including many <unk> mutations and splice variant such as <unk> seven.
James B. Breitmeyer: We have recently opened several top academic centers to join the Phase 1-2 study, and the investigators are enthusiastic. We are also happy to announce that the fourth dosing cohort of the study is now fully enrolled. Patients in this cohort are receiving 300 milligrams of ARN534 once per day orally. The decision to move to this dose level was made by the study's Safety Review Committee after reviewing data from patients treated to date, including those at the third dose level of 160 milligrams of ARN534 daily.
James B. Breitmeyer: We have recently opened several top academic centers to join the phase one two study and the investigators are enthusiastic.
James B. Breitmeyer: We are also happy to announce that the fourth dosing cohort of the study is now fully enrolled pay.
James B. Breitmeyer: Patients in this cohort are receiving 300 milligrams of Arn 534 once per day orally <unk>.
James B. Breitmeyer: The decision to move to this dose level was named by the Study's Safety Review Committee after reviewing data from the patients treated to date, including those of the third dose level of 160 milligrams and 534 daily.
James B. Breitmeyer: Based on preclinical analyses, we are optimistic that study participants are receiving doses of Oncrete 534 that may be within the active dose range for anti-tumor activity. We plan to share an initial clinical data update for this program late in the second quarter of this year. Now switching gears to ONC808, our ROAR1 targeting ontologous CAR-T, we are also happy to announce that the Phase 1-2 study in patients with relapsed or refractory aggressive B-cell lymphoma, including patients who have failed previous CD19 CAR-T treatment, is again open and enrolling patients.
James B. Breitmeyer: Just on preclinical analyses, we are optimistic that study participants are receiving doses I'm on page 54534 that may be within the active dose range for anti tumor activity.
James B. Breitmeyer: We plan to share an initial clinical data update for this program late in the second quarter of this year.
James B. Breitmeyer: Now switching gears to 808, our raw one targeting autologous car T. We are also happy to announce that the phase one two study in patients with relapsed or refractory aggressive b cell lymphoma, including patients who have failed previous CD 19 car T treatment.
James B. Breitmeyer: Again open and enrolling patients.
James B. Breitmeyer: We'd like to thank the team and our investigators for the swift implementation of protocol amendments, which include modified eligibility criteria, increased monitoring for infection, and evaluating a lower dose. As a reminder, we recently shared an encouraging initial response signal at the 1 times 10 to the 6 CAR-T cells per kilogram dose, with 2 of the 3 patients achieving complete metabolic responses, and the 3rd achieving a partial response, as of the December 4th cutoff date. We expect to report updated clinical results, including data from patients treated with the new dosing schedule, in mid-2024. With that, I will now turn the call back to our CFO, Rich Vincent. Rich?
James B. Breitmeyer: We'd like to thank the team and our investigators for the Swift implementation of protocol amendments, which include modifying eligibility criteria increased monitoring for an infection and evaluating lower doses.
James B. Breitmeyer: As a reminder, we recently shared an encouraging initial response signal at the one times 10 to the sixth car T cells per kilogram dose with two of the three patients achieving complete metabolic response and the third achieving a partial response as of the December 4th cutoff.
James B. Breitmeyer: Date.
James B. Breitmeyer: We expect to report updated clinical results, including data from patients treated with the new dosing schedule in mid 2024.
Richard G. Vincent: With this I turn that I will now turn the call back to our CFO Richard Vincent Rich.
Richard G. Vincent: Thank you Jim.
Richard G. Vincent: Our revenue is currently derived from research and development grants received from the NIH. Our grant revenue was $0.6 million for the first quarter ended March 31, 2024. Our total operating expenses for the first quarter ended March 31, 2024, were $9.3 million, including $1.4 million in non-cash, stock-based compensation expenses. In the first quarter, research and development expenses totaled $6 million, and general and administrative expenses totaled $3.3 million. The net loss for the fourth quarter was $8.4 million, for a loss of $2.83 per share, basic and diluted.
Richard G. Vincent: Our revenue is currently derived from research and development grants received from the NIH.
Richard G. Vincent: Our grant revenue was <unk> 6 million for the first quarter ended March 31 2024.
Richard G. Vincent: Our total operating expenses for the first quarter ended March 31, 2024 were $9 3 million, including $1 4 million in noncash stock based compensation expense.
Richard G. Vincent: In the first quarter research and development expenses totaled $6 million and general and administrative expenses totaled $3 3 billion.
Richard G. Vincent: Net loss for the fourth quarter was $8 4 million for a loss of $2 83 per share basic and diluted.
Richard G. Vincent: As of March 31, 2024, we had approximately 3 million shares of Common Stock outstanding, 27 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 both programs moving forward towards significant data points. For Onc 534, our lead DARI product candidate, we expect to present initial clinical data in the latter part of this second quarter of 2024, with additional readouts in the fourth quarter of 2024.
Richard G. Vincent: As of March 31, 2024, we had approximately 3 million shares of common stock outstanding 27 million in cash cash equivalents and short term investments and no debt.
Richard G. Vincent: We believe these funds will be sufficient.
Richard G. Vincent: Sufficient to fund our operations into the first quarter of 2025.
Richard G. Vincent: With respect to upcoming milestones remain on track for both programs moving forward.
Richard G. Vincent: Towards significant data points.
Richard G. Vincent: For <unk> 534, our <unk> product candidate, we expect to present initial clinical data.
Richard G. Vincent: In the latter part of the second quarter of 2024 with additional Readouts in the fourth quarter of 2024.
Richard G. Vincent: We expect to report a clinical data update in mid-2024, with additional data readouts in the fourth quarter of 2024. With that, I will turn things back to the operator for the Q&A portion of this afternoon's call.
Richard G. Vincent: Wrong date away, our rore, one autologous car T. We expect to report clinical data update in mid 2024 with additional data readouts in the fourth quarter of 2024.
Richard G. Vincent: With that I will turn things back to the operator for the Q&A portion of this afternoon's call.
Operator: Thank you. At this time, we will be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question. For participants using sneaker equipment, it may be necessary to pick up your handset before pressing the start button. One moment, please, while we poll for questions. Our first question comes from the line of Carl Byrnes with Northland Capital Markets; please proceed with your question.
Speaker Change: Thank you at this time, we will 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 you May Press Star two if you would like to remove your question.
Speaker Change: For participants using speaker equipment, it may be necessary to pick up your handset before pressing destocking.
Carl Edward Byrnes: One moment, please while we poll for questions.
Carl Edward Byrnes: Our first question comes from the line of Carl.
Carl Edward Byrnes: Borrowings with Northland capital markets. Please proceed with your question.
Carl Edward Byrnes: Thanks for the question and congratulations on your progress. You know, with respect to 534 in terms of the 300 dose in the dose escalation study. Do you expect to get it? I think you mentioned that you had full enrollment in that cohort. How many were in that cohort? And also, would you suspect that you would go to the higher six? 600 milligram dose prior to the mid, excuse me, year-end update? Thanks.
Carl Edward Byrnes: Thanks for the question and congratulations on your progress.
Carl Edward Byrnes: With respect to 534.
Carl Edward Byrnes: In terms of the 300 dose.
Carl Edward Byrnes: Most escalation study do you expect to give you I think you mentioned that you had full enrollment in that cohort. How many were in that cohort and then also would you suspect that you would go into the higher six 600.
Carl Edward Byrnes: Gram dose.
Carl Edward Byrnes: Prior to that.
Carl Edward Byrnes: Mid <unk>.
Carl Edward Byrnes: Excuse me year end update thanks.
James B. Breitmeyer: So we'll have Salim answer that question.
Selim: So we'll have Selim I answer that question.
Salim Yazji: Yeah, actually, we've already fully enrolled in those cohort three patients in this cohort, and we're still in the DLT period. And we expect to have SRC happening mid this month, towards the end of this month, actually. And then if everything's fine, we'll escalate to the next dose cohort, which is 600 million.
Salim: Yes, so actually we already fully enrolled and dosed.
Salim Yazji: Cohort three patients in this cohort were still in the DLT.
Salim Yazji: Period, and we expect to have a src happening mid this month towards the end of this month actually and then.
Salim Yazji: Everything's fine would escalate to the next dose cohort, which is a 600 milligram.
Salim Yazji: Yeah, so Carl, assuming that everything runs On Track, we should have some data from the 600 milligram cohort by the time we announce results.
Salim Yazji: Yeah, so karl assuming that everything runs.
Salim Yazji: On track, we would have some data from the 600 milligram cohort by the time, we announced results.
Carl: Great. Thanks, so much.
Hartaj Singh: Thank you. Our next question comes from the line of Hartaj Singh with Oppenheimer and Company. Please proceed with your question.
Speaker Change: Thank you our.
Speaker Change: Our next question comes from the line of a hard time seeing with Oppenheimer <unk> Company. Please proceed with your question.
James B. Breitmeyer: Great, thank you. I just have a couple of questions. One is, again, just going back to prostate cancer. You know, amateur receptor signaling, the current, you know, when these molecules are given redosed, Jim, it seems with an ARSI, after the first line, the second line ARSI is given, you've got about 25% responses, you know, maybe a little bit higher, but that's what the academic literature seems to suggest. Is that the way to think about how, you know, the update could happen in the second quarter with 534? Is that too early? I just got a quick question on follow-up on Aurora 1.
Hartaj Singh: Great. Thank you I just got a couple of questions.
James B. Breitmeyer: One is again just going back to <unk>.
James B. Breitmeyer: I'll stay cancer.
James B. Breitmeyer: And as you receptor signaling.
James B. Breitmeyer: Hunt.
James B. Breitmeyer: When when these molecules are given.
James B. Breitmeyer: Dose.
James B. Breitmeyer: Jim.
James B. Breitmeyer: It seems with Arris hi.
James B. Breitmeyer: After first line second line as far as given you've talked about 25% responses.
James B. Breitmeyer: You know, maybe a little bit higher but that's what the academic literature seems to suggest is that the way to think about.
James B. Breitmeyer: How.
James B. Breitmeyer: The update could happen in the second quarter.
James B. Breitmeyer: With 534 is it too early to see data in <unk> like that.
James B. Breitmeyer: Just got a quick question on follow up on <unk>.
James B. Breitmeyer: Sure, and I'll, I'll, I'll take that question. So, I think that the published data on switching from one existing androgen receptor signaling inhibitor to another would be at the low end of what we're expecting. Because, for example, if you switch from enzalutamide to abiraterone, the failure to respond to abiraterone includes the fact that mutations in the ligand-binding domain have developed that the second agent cannot address. So, in our case, 534 is active against, for example, prostate cancer that is resistant to enzalutamide.
James B. Breitmeyer: Sure.
Speaker Change: I'll take that question.
James B. Breitmeyer: So.
James B. Breitmeyer: So I think that the.
James B. Breitmeyer: That the published data on switching from one.
James B. Breitmeyer: Existing androgen receptor signaling inhibitor to another would be at the low end of what we're expecting because for example, if you switch from <unk>.
James B. Breitmeyer: <unk> to Abbott rat around.
James B. Breitmeyer: The failure to respond to the Abbott route around includes the fact that.
James B. Breitmeyer: There that that mutations in the ligand binding domain have developed.
James B. Breitmeyer: The second agent cannot address so in our case we are.
James B. Breitmeyer: <unk>.
James B. Breitmeyer: We are 534 does is active against.
James B. Breitmeyer: For example.
James B. Breitmeyer: Prostate cancer that is.
James B. Breitmeyer: Resistant to and dilutive might so.
James B. Breitmeyer: So it would be active in more cases than you would expect from switching from one ARSI to another. We're also active, again, Splice Variants, which have lost the ligand binding domain entirely, and those do not respond to conventional hormone-related therapies at all.
James B. Breitmeyer: It would be it would it would be active in more cases than you would expect from switching from one.
James B. Breitmeyer: Our site to another we're also active against splice variants, which have lost the ligand binding domain entirely.
James B. Breitmeyer: Those.
James B. Breitmeyer: Do not respond to conventional <unk>.
James B. Breitmeyer: Hormone related therapies at all.
James B. Breitmeyer: Great. Thank you, Jim. And then the other question is, just on rule one, is there any color or updates you can provide on the durability of those two, you know, CRs that you saw in December? And thanks for the question.
Speaker Change: Great. Thank you Jim and then.
Speaker Change: The other question is just a more one.
James B. Breitmeyer: Is there any color or updates you can provide on the durability of those two.
Jim: <unk> that you saw in December and thanks for the question.
James B. Breitmeyer: Sure. Salim, do you want to comment? Hartaj has to wait, I know, but you can speak in generalities.
Jim: Sure Selim do you want to comment.
Salim Yazji: We're a.
Salim Yazji: Our touch has to wait I know, but you can speak in generalities.
Salim Yazji: Sure. So, you know, we're not going to go into the details, but as you know, the patients that we've been treating in Cohort 1, those patients who failed multiple prior therapy, including prior CD19 CAR-T, as well as some of them CD79 and by specific treatment. So those are very heavily pre-treated patients, and usually, the expectation of those patients is very, very low and short progression-free survival. So to answer your question, I think we are enthusiastic about what we are seeing about the durability of this response, but taking into consideration that we have very, very sick, very heavily to
Salim Yazji: Sure. So you know.
Salim Yazji: We're not going to go into the details, but as you know the patients since we've been treating in the cohort one so those patients who failed multiple prior therapies, including probably a CD 19 car T as well some of them.
Salim Yazji: <unk> 79, and by specific treatments. So, it's a very heavily pretreated patients and and usual easy.
Salim Yazji:
Salim Yazji: The expectation of those patients is very.
Salim Yazji: Very low and in short in progression free survival. So to answer your question I think we are.
Salim Yazji: And.
Salim Yazji: And so as you think about what we are seeing a bunch of durability of.
Salim Yazji: The response, but taking considerations as we have been very sick very heavily interested patients.
Hartaj Singh: Great. Thank you. I really appreciate that. Thanks for the question.
Speaker Change: Great. Thank you really appreciate that thanks for the question.
Carl Edward Byrnes: Thank you. Our next question comes from the line of Robert Byrnes with HC Wainwright. Please proceed with your question.
Speaker Change: Thank you.
Hartaj Singh: Our next question comes from the line of Robert Burns with H C. Wainwright. Please proceed with your question.
Carl Edward Byrnes: Hi guys. Thanks for taking my questions. I can grasp on the progress. Just two questions for me regarding 808.
Carl Edward Byrnes: Hi, guys. Thanks for thanks for taking my questions and congrats on the progress I have just two questions from me regarding 808, so I know that in the current trial design.
Carl Edward Byrnes: So, I know that in the current trial design, it's only phase one in which you're looking at the CD19 failed CAR-T patients or those who are ineligible for CD9-targeted CAR-T. I was curious whether you would also try to explore that in phase two, or are you trying to go for a more broader population? And secondly, with regard to the modified eligibility criteria, how do you think that that is going to help from a safety profile perspective?
Carl Edward Byrnes: Only phase one and whats youre looking at the CD 19 failed.
Carl Edward Byrnes: Car T patients are those who are on that alright, and eligible for car T. <unk> targeted car T. I was curious whether you would also try to explore that in phase two or are you trying to form a broader population and then secondly, with regards to modify the eligibility quite so how do you think that that is going to help us from a safety profile perspective.
James B. Breitmeyer: So let me start with the safety question, Rob. So we had we're we are
Speaker Change: So let me I can start from the with the safety question Rob.
James B. Breitmeyer: So.
James B. Breitmeyer: We had where we are.
James B. Breitmeyer: We're responding to this
James B. Breitmeyer: We're responding to the unfortunate case of grade five toxicity in a patient earlier in the dose escalation, and we think we learned some things about that patient that we can use to improve overall safety for the rest of the study, which is what you're asking. So, for example, we're no longer allowing bulky diseases, which that patient had. We're lowering the upper age limit. That patient was 80 years old, and we're taking a number of measures to try to detect and treat any kind of occult infection, which, as I'm sure you know well, infection is the number one cause of non-tumor death in patients who have undergone CD19 CAR T therapy because they've had their B cells obliterated by the therapy.
James B. Breitmeyer: We're responding to the.
James B. Breitmeyer: Unfortunate.
James B. Breitmeyer: In case of a great grade <unk> toxicity.
James B. Breitmeyer: And in a patient earlier in the in the dose escalation and we think we've learned some things about him about that.
James B. Breitmeyer: That patient that we can use to improve overall safety for the rest of the study which is what you're asking so for example.
James B. Breitmeyer: We were no longer, allowing bulky disease, which that patient had.
James B. Breitmeyer: We're lowering the upper age limit that.
James B. Breitmeyer: That patient was 80 years old.
James B. Breitmeyer: And we're taking a number of measures to try to detect and and have treated any kind of a cult infection.
James B. Breitmeyer: Which which as I'm sure you know well infection is the number one cause of non tumor death in patients who have undergone CD 19 car T therapy, because they've had their b cells obliterated by the by the therapy. So so with these are these are these are the three.
James B. Breitmeyer: So, these are the three measures that we do feel will add to the many safety measures that were already built into the study. So, um, and, um, your first question, um, I, um, I'm going to have was suitable for Salim, except I've forgotten what it was. So if you could repeat it.
James B. Breitmeyer: Our measures that we do feel.
James B. Breitmeyer: Will.
James B. Breitmeyer: It will add to the many safety measures that were already built into the study.
James B. Breitmeyer: So.
James B. Breitmeyer: And.
Speaker Change: Your first question.
Speaker Change: I'm gonna have with suitable for saline, except I've forgotten what it was so if you could repeat it please.
Carl Edward Byrnes: Yeah, so I know in the first, in the phase one portion, you're allowing for G19 failed CAR T patients, but that's only for phase one. Are you also thinking about considering looking at that population specifically, given the unmet need there?
Salim Yazji: Yeah, So I know in the first.
Carl Edward Byrnes: Phase one portion you're you're allowing for C. 19 failed car T patients, but that's only for the phase. One are you also thinking about considering looking at that population specifically given the unmet need there.
Salim Yazji: Yeah, so actually, we, you know, as you know, we are still in phase one, but we are learning as we go. I think in phase two, we're probably going to expand the patient population based on what we see in phase one. And and yes, to answer your question, I think if we see signals from those patients in phase one, we're probably going to expand that. Yeah, yeah, and the protocol allows CD 19 to fail.
Salim Yazji: Yes, so actually we.
Salim Yazji: As you know.
Salim Yazji: We are still in the phase one, but we are learning as we go I think that the phase two we are probably going to expand that piece.
Salim Yazji: Patient population based on what we see in the phase, one and and and and yes to answer your question I think if we see a signals from from those patients in phase one Republican expense population.
James B. Breitmeyer: Yeah, and the protocol allows CD19 failures in phase two, while FDA required us to have either CD19, people who had failed CD19 CAR T, or patients who were ineligible or had refused, in phase one. So, we're removing that restriction for phase two.
Salim Yazji: Yeah, Yeah in the protocol allows CD 19 failures in phase two.
James B. Breitmeyer: While FDA required us to have either a peep people, who had failed CD 19 car.
James B. Breitmeyer: Car T or or patients who are ineligible or had refused it.
James B. Breitmeyer: In phase one so so were removing that restriction for phase two.
Speaker Change: Awesome. Thank you.
Speaker Change: Thank you Rob.
Brian Kemp Dolliver: Thank you. And our next question comes from the line of Kent Dolliver with Brookline Capital Markets. Please proceed with your question.
Speaker Change: Thank you.
James B. Breitmeyer: And our next question comes from the line of Malibu with Brookline Capital markets. Please proceed with your question.
Brian Kemp Dolliver: All right, thanks. And just to continue with the Unknown Speaker 8.08 discussion around the enrollment criteria. And admittedly, you know, this is early on, but based on the changes you've made, and whatever other data you looked at in making those decisions, how are you thinking? Does that have any noticeable difference on the addressable market that you'd previously estimated? Kemp, thanks for the question and
Brian Kemp Dolliver: Alright. Thanks.
Brian Kemp Dolliver: Just to continue with the.
Brian Kemp Dolliver: Oh wait a discussion around the enrollment criteria and admittedly this.
Brian Kemp Dolliver: It is early on but based on the changes you've made.
Kemp: And whatever other data you you looked at in making those decisions.
Kemp: How are you thinking does that have any notice of a difference on the addressable market that you.
Kemp: We previously estimated.
James B. Breitmeyer: Kemp, thanks for the question, and no, we don't think that the modified eligibility criteria changes the addressable market.
Kemp: Ken Thanks for the question and no we don't think that the.
Speaker Change: The modified eligibility criteria changes the addressable market.
James B. Breitmeyer: Yeah.
Speaker Change: Great. Thank you.
Speaker Change: Thank you.
Speaker Change: Thank you.
Operator: We have reached the end of the question and answer session, and I'll now turn the call back over to CEO James Breitmeyer for closing remarks.
Speaker Change: And we have reached the end of the question and answer session and I'll now turn the call back over to CEO James Great My Meier for closing remarks.
James B. Breitmeyer: Thank you, Shamali. Overall, we are very encouraged and pleased with the pace of execution in both our clinical programs, 534 and 808, and the enthusiasm of our investigators for these studies. We're looking forward to potentially significant clinical data updates for both programs in the coming months. Thank you for joining us today, and we look forward to updating you throughout the year. And this concludes today's conference, and you may disconnect your lines at this time. Thank you for your participation. [inaudible]
James B. Breitmeyer: Thank you Mollie.
James B. Breitmeyer: Overall, we are very encouraged and pleased with the pace of execution in both our clinical programs on slide three for an 808 and the enthusiasm of our investigators for for these studies, we're looking forward to potentially significant clinical data updates for both programs in the coming months.
James B. Breitmeyer: Thank you for joining us today, and we look forward to updating you throughout the year.
Operator: And this concludes today's conference, and you may disconnect your lines at this time. Thank you for your participation.
James B. Breitmeyer: And this concludes today's conference and you may disconnect. Your lines at this time. Thank you for your participation.
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