Q2 2022 Curis Inc Earnings Call
Okay.
Okay.
Good afternoon, everyone and welcome to curious as second quarter 2022 earnings conference call.
Operator: Good afternoon, everyone, and welcome to Curis' second quarter 2022 earnings conference call.
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After the Companys prepared remarks, all participants will have an opportunity to ask questions.
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Operator: Please also note today's event is being recorded.
Please also note today's event is being recorded.
At this time I'd like to turn the conference over to curious as Vice President of Investor Relations and corporate Communications, Craig West Sir. Please go ahead.
Operator: At this time, I'd like to turn the conference over to Curis' Vice President of Investor
Operator: Relations and Corporate Communications, Craig West.
Craig West: Sir, please go ahead.
Thank you, Jamie and welcome to <unk> second quarter, 2022 earnings call.
Craig West: Thank you, Jamie, and welcome to Curis' second quarter 2022 earnings call.
Before we begin I would like to encourage everyone to go to the curious investors section of our website at Www Dot curious dot com to find our second quarter 2022 earnings release and related financial tables I.
Craig West: Before we begin, I would like to encourage everyone to go to the Curis Investor section, of our website at www.curis.com to find our second quarter 2022 earnings release and related financial tables.
Craig West: I would also like to remind everyone that during the call, we will be making forward-looking, statements which are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and actual results may, differ materially.
I would also like to remind everyone during.
That during the call we will be making forward looking statements, which are based on our current expectations and beliefs.
These statements are subject to certain risks and uncertainties and actual results may differ materially.
Craig West: For additional details, please see our SEC filings.
For additional details please see our SEC filings.
Joining me on today's call are Jim Dentzer, President and Chief Executive Officer Bill.
Craig West: Joining me on today's call are Jim Denser, President and Chief Executive Officer, Bill Stein Krause, Chief Financial Officer and Chief Administrative Officer, and Bob Martel, Head of R&D.
Bill Steinkrauss, Chief Financial Officer, and Chief administrative officer, and Bob Martell head of R&D.
Craig West: We will also be available for a question and answer period at the end of the call.
We will also be available for a question and answer period at the end of the call.
Craig West: I'd now like to turn the call over to Jim.
I'd now like to turn the call over to Jim Jim.
James Dentzer: Jim.
James Dentzer: Thank you, Craig.
Thank you Craig.
James Dentzer: Good afternoon, everyone, and welcome to Curis' second quarter earnings call.
Good afternoon, everyone and welcome to curious as second quarter earnings call.
Every day it curious we strive to develop the next generation of first in class cancer therapies that meaningfully improve and extend patients' lives.
James Dentzer: Every day at Curis, we strive to develop the next generation of first-in-class cancer therapies, that meaningfully improve and extend patients' lives.
James Dentzer: We have several updates for you this quarter.
We have several updates for you this quarter.
James Dentzer: First, as we've noted previously, the path of drug development is seldom a straight line, and the second quarter began with FDA placing a partial clinical hold on our take-aim studies in leukemia and lymphoma in April. We're having productive discussions with the agency to bring these discussions to a resolution, as quickly as possible.
First as we've noted previously.
<unk> drug development is seldom a straight line and the second quarter began with F. D. A placing a partial clinical hold on our take games studies in leukemia and lymphoma in April .
We're having productive discussions with the agency to bring these discussions to a resolution as quickly as possible.
James Dentzer: Second, we're delighted to announce that we have appointed a new CFO, which I'll talk, about more in a minute.
Second we are delighted to announce that we have appointed a new CFO , which I'll talk about more in a minute.
Third the second quarter also saw several positive presentations on <unk>, who started at <unk> and Ehealth, both by our internal team at curious and by several of our partners in academia with whom we are expanding the frontiers of Iraq for research.
James Dentzer: Third, the second quarter also saw several positive presentations on emivucertib at ASCO, and EHA, both by our internal team at Curis and by several of our partners in academia, with whom we are expanding the frontiers of IREC4 research. These presentations included the first data from the combination arm of the take-aim lymphoma, study, as well as additional data in solid tumors and novel discoveries that are deepening our understanding of IREC4 biology. In short, we're encouraged that in emivucertib, we have a drug that works as a single agent, in exactly the places our research predicted.
These presentations included the first data from the combination arm of the take game lymphoma study as well as additional data in solid tumors.
And novel discoveries that are deepening our understanding of Iraq for biology.
In short we were encouraged that in Abu search it we have a drug that works as a single agent in exactly the places our research predicted.
James Dentzer: To start our update tonight, I'd like to welcome Diantha Duvall, who is joining the Curis team as our new CFO. Diantha began her career with PricewaterhouseCoopers and over the last 20 years has built an impressive track record of financial leadership at Merck, Biogen, Bioverative, and Genosha. We're delighted to have such a well-respected industry veteran join the team.
To start our update Tonight I'd like to welcome Diantha Duvall, who is joining the curious team as our new CFO .
Diantha began her career with Pricewaterhouse Coopers.
And over the last 20 years has built an impressive track record of financial leadership at Merck Biogen <unk> and Juno shot we're delighted to have such a well respected industry veteran joined the team.
James Dentzer: I'd also like to take this opportunity to thank Bill Steinkraus.
I'd also like to take this opportunity to thank Bill Steinkrauss.
James Dentzer: He has been a key leader on the executive team at Curis, and we wish him all the best in his future endeavors.
He has been a key leader on the executive team at Trs and we wish him all the best in his future endeavors.
James Dentzer: Turning now to our pipeline and our lead asset, Emavucertib, our first-in-class program specifically designed to target IRAC4 and FLT3. Emavucertib is currently being evaluated in three clinical studies.
Turning now to our pipeline and our lead asset <unk>. Our first in class program, specifically designed to target Iraq for Insulet three.
And mobile search or is currently being evaluated in three clinical studies.
James Dentzer: First, the Take-Aim Leukemia Study, a Phase I-II study with both monotherapy and combination arms for patients with relapsed or refractory acute myeloid leukemia, or AML, and high-risk myelodysplastic syndromes, or MDS.
First the take in leukemia study.
Our phase one two study with both monotherapy and combination arms for patients with relapsed or refractory acute myeloid leukemia or AML and.
And high risk Myelodysplastic syndromes.
Or M D S.
James Dentzer: Second, the Take-Aim Lymphoma Study, a Phase I-II combination study with ibrutinib for patients with relapsed or refractory NHL, or other hematologic malignancies.
Second.
The take aimed lymphoma study.
As one two combination study with ibrutinib for patients with relapsed or refractory NHL or other hematologic malignancies.
James Dentzer: And third, the Phase II LUCA Study, evaluating Emavucertib in patients with lower-risk MDS.
And third the phase two lupus study evaluating <unk> in patients with lower risk Mds.
James Dentzer: Starting with the Take-Aim Leukemia Study, we continue to work with FDA on resolving the partial clinical hold. We've had productive interactions with the agency and hope to provide an update soon.
Starting with the take game leukemia study, we continue to work with FDA on resolving the partial clinical hold we've had productive interactions with the agency and hope to provide an update soon.
James Dentzer: At ASCO and EHA, we presented positive clinical data showing early and compelling response rates in AML or MDS patients with spliceosome or FLT3 mutations. These results demonstrate both a well-tolerated regimen and improved anticancer activity compared with the current standard of care.
At <unk>, we presented positive clinical data showing early and compelling response rates in AML or Mds patients with spliceosome or flit three mutations.
These results demonstrate both are well tolerated regimen and improved anticancer activity compared with the current standards of care.
James Dentzer: As the leader in IRAC-IV, we are pleased to be hosting an IRAC-IV Symposium on October 7th.
As the leader in Iraq for we are pleased to be hosting in Iraq for symposium on October 7th.
James Dentzer: In this symposium, we'll be bringing together experts from academia, clinicians, and other corporates in panel discussions to be clear that IRAC-IV is not a new disease.
In this symposium will be bringing together experts from academia clinicians and other corporates in panel discussions.
To be clear this will not be a forum for a curious data update the aim of the symposium is to address and advanced topics of key interest to everyone in the Iraq for community.
James Dentzer: Remember, this will not be a forum for a curious data update.
James Dentzer: The aim of the symposium is to address and advance topics of key interest to everyone in the IRAC-IV community. We'll be releasing more details on this event soon.
We'll be releasing more details on this event soon.
Now, let's turn to our study of ammo, who started in B cell cancers, and the take game lymphoma study of patients with NHL and CLO.
James Dentzer: Now let's turn to our study of Emavucertib in B-cell cancers and the Take-Aim Lymphoma Study of patients with NHL and CLL.
James Dentzer: Our first look at initial data presented at ASCO and EHA showed the results from nine evaluable patients. Eight of the nine patients experienced tumor burden reduction, including two CRs and two PRs. We share the excitement of our investigators that one of the observed CRs was in a patient who had received prior treatment with ibrutinib, suggesting that the combination may be able to overcome resistance to ibrutinib.
Our first look at initial data presented at Astro anyhow.
Showed the results from nine Evaluable patients.
Eight of the nine patients experienced tumor burden reduction, including to see ours and two P. R's.
We share the excitement of our investigators that one of the observed see ours was in a patient who had received prior treatment with ibrutinib, suggesting that the combination may be able to overcome resistance to ibrutinib.
James Dentzer: Also, at ASCO and EHA this year, we presented work by Curis scientists describing the novel, observation that IRAC4 localizes to the nucleus in cancer cells.
Also at <unk> and El <unk>. This year, we presented work by cure scientists, describing the novel observation that Iraq for localized to the nucleus in cancer cells.
With nuclear Iraq for is found with two Nf Kappa B proteins P 50, and P fifth P 65.
James Dentzer: When nuclear IRAC4 is found with two NF-kappa B proteins, P50 and P65, this triple presence, in the nucleus is associated with better patient responses to emibucertib.
This triple presence in the nucleus is associated with better patient responses to MF who started.
This new finding deepens, our understanding of Iraq for biology, and its role in cancer.
James Dentzer: This new finding deepens our understanding of IRAC4 biology and its role in cancer and, marks an important next step in the development of biomarkers for identifying patients who could benefit from treatment with emibucertib.
And marks an important next step in the development of Biomarkers for identifying patients who could benefit from treatment with him up a circuit.
The Astro Indeed Hawk conferences also saw presentations by our partners in academia, showing MLB sort tips potential in several other tumor types, including solid tumors, such as gastric cancer melanoma brain metastases and primary CNS lymphoma.
James Dentzer: The ASCO and EHA conferences also saw presentations by our partners in academia showing emibucertib's, potential in several other tumor types, including solid tumors, such as gastric cancer, melanoma brain metastases, and primary CNS lymphoma.
James Dentzer: In short, the second quarter was an exciting time for IRAC4 research and expanding the, potential of emibucertib.
In short the second quarter was an exciting time for Iraq for research and expanding the potential of Emma who starts up.
Now, let's move to our second asset C. I 80, 993, the first in class monoclonal antibody to antibody we are developing in collaboration with Ami next for the treatment of patients with relapsed or refractory solid tumors.
James Dentzer: Now let's move to our second asset, CI8993, the first-in-class monoclonal anti-VISTA antibody we're developing in collaboration with Immunext for the treatment of patients with relapsed or refractory solid tumors. CI8993 is designed to antagonize the VISTA signaling pathway. By blocking VISTA, a checkpoint associated with T-cell suppression, we hope to increase, T-cell-mediated immune function. In preclinical models, addressing VISTA demonstrates exciting anti-cancer potential, both in monotherapy, and in combination with CTLA-4 and PD-1.
See I 80, 993 is designed to antagonize the Vista signaling pathway.
By blocking Vista.
Point associated with T cell suppression.
We hope to increase T cell mediated immune function.
In preclinical.
The nickel models addressing Vista demonstrates exciting anticancer potential.
Both in monotherapy and in combination with C. T L. A four and PD one.
We believe C. I 80, 993 is the most advanced anti Vista antibody currently in clinical development.
James Dentzer: We believe CI8993 is the most advanced anti-VISTA antibody currently in clinical development, and we're pleased to announce that we have cleared the 0.6 milligram per kilogram dose level in our dose escalation study and are currently enrolling at the dose level of one mg per kg.
We are pleased to announce that we have cleared the 0.6 milligram per kilogram dose level in our dose escalation study and are currently enrolling at the dose level of one make per cake.
We are hosting the second annual Vista Symposium this year on September 23rd.
James Dentzer: We are hosting the second annual VISTA symposium this year on September 23rd.
As with the Iraq for Symposium this will not be a forum for a curious data update the aim of this symposium is to address and advanced topics of key interest to everyone in the Vista community.
James Dentzer: As with the IRAC-IV symposium, this will not be a forum for a QRIS data update.
James Dentzer: The aim of the symposium is to address and advance topics of key interest to everyone, in the VISTA community.
We look forward to providing a curious data update later this year.
James Dentzer: We look forward to providing a QRIS data update later this year.
In summary, we're pleased with the progress we've made this quarter. We're excited to have Dan onboard and we look forward to providing important updates on both M. A asserted and C. I E. The 993 in the weeks and months ahead.
James Dentzer: In summary, we're pleased with the progress we've made this quarter.
James Dentzer: We're excited to have Diantha on board, and we look forward to providing important updates, on both emibucertib and CI8993 in the weeks and months ahead.
James Dentzer: With that, I'll turn the call over to Bill to review our financial results for the quarter.
With that I'll turn the call over to Bill to review our financial results for the quarter Bill.
Bill Stein Krause: Bill?
Bill Stein Krause: Thank you, Jim.
Thank you Jim.
Bill Stein Krause: QRIS continues to execute on its strategy from a place of financial strength.
<unk> continues to execute on its strategy from a place of financial strength.
Bill Stein Krause: For the second quarter of 2022, QRIS reported a net loss of $15.9 million, or 17 cents per, share, on both a basic and diluted basis, as compared to a net loss of $10.8 million, or 12 cents per share, on both a basic and diluted basis for the same period in 2021.
For the second quarter of 2022 curious reported a net loss of $15 $9 million or 17 cents per share on both a basic and diluted basis.
As compared to a net loss of $10.8 million or 12 cents per share on both a basic and diluted basis for the same period in 2021.
Bill Stein Krause: For the six months ended June 30, 2022, we reported a net loss of $32 million, or $0.35, per share, as compared to a net loss of $20.8 million, or $0.23 per share, for the same period in 2021. Expenses for the second quarters of 2022 and 2021 were $2.4 million and $2.3 million, respectively.
For the six months ended June 32022, we reported a net loss of $32 million or <unk> 35 per share.
As compared to a net loss of $28 million or 23 cents per share for the same period in 2021.
Revenues for the second quarters of 2022, and 2021 were $2 $4 million and $2 $3 million respectively.
Revenues for the six months ended June 32022, and June 32021 or $4.5 million.
Bill Stein Krause: Revenues for the six months ended June 30, 2022, and June 30, 2021, were $4.5 million.
Operating expenses for the second quarter of 2022 were $17.5 million as compared to $12 $9 million for the same period 2021.
Bill Stein Krause: Operating expenses for the second quarter of 2022 were $17.5 million, as compared to, $12.9 million for the same period in 2021. Operating expenses for the six months ended June 30, 2022, were $34.6 million, as compared, to $23.9 million for the same period in 2021, and comprised the following. Cost of royalty revenues, which comprised amounts due to third-party university patent, licensors in connection with Genentech and Roche's error of edge net sales, were less than $0.1 million for the second quarter of 2022, as compared to $0.1 million for the same period in 2021.
Operating expenses for the six months ended June 32022 were $34 $6 million as compared to $23 $9 million for the same period 2021.
And comprised the following.
Cost of royalty revenues, which comprised of amounts due to third party University patent license stores in connection with Genentech and Roche's Arab edge net sales were less than $1 million for the second quarter of 2022.
As compared to <unk> $1 million for the same period 2021.
Cost of royalty revenues for the six months ended June 32022.
Bill Stein Krause: Cost of royalty revenues for the six months ended June 30, 2022, were $0.1 million, as, compared to $0.2 million for the same period in 2021.
Point $1 million as compared to point $2 million for the same period in 2021.
Research and development expenses were $12 $3 million for the second quarter of 2022.
Bill Stein Krause: Research and development expenses were $12.3 million for the second quarter of 2022, as, compared to $8.8 million for the same period in 2021. Increase was primarily attributable to increased consulting services and higher personnel costs, as a result of additional headcount. Research and development expenses were $23.8 million for the six months ended June 30, 2022, as compared to $15.5 million for the same period in 2021.
As compared to $8 $8 million for the same period 2021.
The increase was primarily attributable to increased consulting services and higher personnel costs as a result of additional head count.
Research and development expenses were $23 $8 million for the six months ended June 32022, as compared to $15 $5 million for the same period 2021.
General and administrative expenses were $5 $1 million for the second quarter ended June 32022.
Bill Stein Krause: General and administrative expenses were $5.1 million for the second quarter ended June, 30, 2022, as compared to $4.1 million for the same period in 2021. The increase in G&A expense was driven primarily by higher costs for personnel, stock-based, compensation, and insurance, as compared to the prior year.
As compared to $4 $1 million for the same period in 2021.
The increase in G&A expense was driven primarily by higher costs for personnel stock based compensation and insurance as compared to the prior year.
General and administrative expenses were $10 $8 million for the six months ended June 32022.
Bill Stein Krause: General and administrative expenses were $10.8 million for the six months ended June 30, 2022, as compared to $8.2 million for the same period in 2021.
As compared to $8 $2 million for the same period in 2021.
For the second quarter of 2022 and 2021.
Bill Stein Krause: For the second quarter of 2022 and 2021, total other expense was $0.9 million and $0.2, million, respectively. Total other expense primarily consisted of imputed interest expense related to royalty, payments, partially offset in the second quarter of 2021 by a gain of $0.9 million related to extinguishment of debt.
Other expense was point $9 million in point $2 million respectively.
Total other expense primarily consisted of imputed interest expense related to royalty payments.
Partially offset in the second quarter of 2021, but again.
Point $9 million related to extinguishment of debt.
Bill Stein Krause: Total other expense was $1.9 million for the six months ended June 30, 2022, as compared, to $1.3 million for the same period in 2021.
Total other expense was $1 $9 million for the six months ended June 32022, as compared to $1.3 million for the same period 2021.
As of June 32022, curious as cash cash equivalents and investments.
Bill Stein Krause: As of June 30, 2022, Curis' cash, cash equivalents, and investments totaled $107.2 million, and, there were approximately 91.8 million shares of common stock outstanding. We are in a strong cash position and continue to expect that our existing cash and investments, should enable us to maintain our planned operations into 2024.
$107 $2 million and.
And there were approximately 91 8 million shares of common stock outstanding.
We are in a strong cash position and continue to expect that our existing cash and investments should enable us to maintain our planned operations into 2024.
With that I'd like to open the call for questions operator.
Bill Stein Krause: With that, I'd like to open the call for questions.
Operator: Operator?
Operator: Ladies and gentlemen, we will now begin the question and answer session.
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To withdraw your question you May press Star two.
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Operator: Again, that is star and then one to join the question queue.
Again that is star and then one to join the question queue.
Our first question today comes from <unk>.
Operator: Our first question today comes from Sumit Roy from Jones Research.
<unk> Roy from Jones Research. Please go ahead with your question.
Soumit Roy: Please go ahead with your question.
Soumit Roy: Hi, everyone.
Hi, everyone. Thank you for taking my question.
Soumit Roy: Thank you for taking my question.
Soumit Roy: We'd love to get some if you have any color on any recent FDA interaction where we were, originally thinking with an average of three months turnaround time from the FDA to hear on the clinical hold if August is still a reasonable timeline or you think there is any reason to think it could be further delayed.
Would love to get some if you have any color on any recent FDA interaction where.
We were originally thinking with an average of three months.
Turnaround time from the F T to hear on the clinical hold if August is still a reasonable timeline or you think there is any reason to think it before the delayed.
Thank you sumit, thanks for for calling in and for your question.
James Dentzer: Thank you, Sumit.
James Dentzer: Thanks for calling in and for your question.
James Dentzer: So, no, actually, I think our experience in this is we look in AML and the prior companies, they put on hold.
So no actually I think are our experience in this as we look in AML in the prior companies. They put on hold and I think they've put five trials in AML on hold in the last 18 months.
James Dentzer: I think they've put five trials in AML on hold in the last 18 months.
It generally takes a quarter or two for them to finish their process asking their collections and collecting the data. So I think we're on track for that as far as I know, but I'd say the discussions are going very well as you may remember the FDA had questions about the patient who died.
James Dentzer: It generally takes a quarter or two for them to finish their process, asking their questions, and collecting the data.
James Dentzer: So I think we're on track for that as far as I know.
James Dentzer: But I'd say the discussions are going very well.
James Dentzer: As you may remember, the FDA had questions about the patient who died. They want more data on that, which makes sense.
They want more data on that which makes sense.
And of course, they've got some questions about dose and project Optimus our hope would be that they get comfortable as we do that that this drug appears to be safe that it offers a compelling.
James Dentzer: And of course, they've got some questions about dose and Project Optimus.
James Dentzer: Our hope would be that they get comfortable as we do, that this drug appears to be safe, that it offers a compelling risk-benefit profile in an area of severe unmet need.
Risk benefit profile in an area of severe unmet need most most patients in the relapsed refractory space as you know have a median survival of 2.3 months.
James Dentzer: Most patients in the relapsed refractory space, as you know, have a median survival, of 2.3 months.
So I think the F D. A I hope is going to come out where we are which is this is a very compelling alternative for clinicians and we'll release that whole process, but they need to finish their their review. So my hope is that they will in due time and discussion.
James Dentzer: So I think the FDA, I hope, is going to come out where we are, which is this is a very, compelling alternative for clinicians, and we'll release that whole process.
James Dentzer: But they need to finish their review.
James Dentzer: So my hope is that they will in due time.
James Dentzer: And discussions seem to be going well.
Discussions seem to be going well.
Soumit Roy: Great.
Great.
Soumit Roy: My second question is on the low-risk MDS, the investigator-run trial.
My second question is.
On the low risk M Dias the investigator on trial.
James Dentzer: If you can provide us any status on that.
If you can provide us any status on that is that trial also on enrollment hold or thats still enrolling.
James Dentzer: Is that trial also on enrollment hold, or that's still enrolled?
James Dentzer: Now, so that's not our study, so that one wouldn't be affected by the FDA hold.
Now so that's not our study says that wouldn't wouldn't be affected by the FDA hold that's in I S. T. In Germany are run by the 17 sites with Dr plots Becker.
James Dentzer: That's an IST in Germany run by the 17 sites with Dr. Platzbecker.
So, but we don't have control or visibility into that study is as an I S T.
James Dentzer: So but we don't have control or visibility into that study as an IST.
James Dentzer: As you know, that's going into a population which is primarily treated with best supportive, care, which is, of course, by definition, not disease modifying.
As you know that's going into a population, which is primarily treated with best supportive care, which is of course by definition not disease modifying. So my hope is that we're going to have a readout from that we continue to hope that there would be one by the end of this year, but of course, we have no control over that.
James Dentzer: So my hope is that we're going to have a readout from that.
James Dentzer: We continue to hope that there would be one by the end of this year.
James Dentzer: But of course, we have no control over that, of where he is in enrollment or what those, data look like at this point in time.
Of where he is an enrollment or what those data look like at this point in time, we're very excited about the outcome. We think it has the potential to put up an oral disease modifying drug into a clearly unmet need space.
James Dentzer: We're very excited about the outcome.
James Dentzer: We think it's the potential to put an oral disease modifying drug into a clearly unmet, need space.
But as I say, you will know when we know when we hear from Doctor plots Becker that the team is ready to to give an update on their results so far.
James Dentzer: But as I say, you will know when we know, when we hear from Dr. Platzbecker that the, team is ready to give an update on their results so far.
Soumit Roy: Great.
James Dentzer: Thank you so much for taking the questions.
Great. Thank you so much for taking the questions.
James Dentzer: Of course.
Okay.
Operator: Thank you.
Operator: Once again, if you would like to ask a question, please press star and 1.
Once again, if you would like to ask a question. Please press star and one.
Operator: Our next question comes from Lee Watek from Cancer Fitzgerald.
Our next question comes from Lee <unk> from Cantor Fitzgerald. Please go ahead with your question.
Li Watsek: Please go ahead with your question.
Li Watsek: Hey, thank you for taking my questions.
Thank you for taking my question I guess I just wanted to follow up on the call.
Li Watsek: I guess I just want to follow up on the clinical hold.
Oh I just wonder if you can share with them all are on I guess, where you are in terms of.
Li Watsek: I just wonder if you can share some color on, I guess, where you are in terms of alignment, with FDA on some of the key issues, like dose selection, and perhaps what additional information may be needed.
Aligning with that.
And I think you are right.
Slide down selection.
And perhaps what additional information may be needed and I was just curious.
Li Watsek: And I was curious if you had any discussion around a potential for, you know, accelerated, approval pathway.
If you had any discussion around.
The potential for accelerated approval pathway.
Robert Martell: Yeah.
Robert Martell: Hi.
Robert Martell: This is Bob Martell.
Yeah, Hi, this is Bob Martell.
Robert Martell: You know, as Jim said, we're in discussions with the agency about this.
As Jim said, we're in discussions with the agency about this and so let me sort of step back and give sort of a high level overview of the situation, maybe a little bit more detail on what Jim provided so far.
Robert Martell: And so let me sort of step back and give sort of a high-level overview of the situation, maybe a little bit more detail than what Jim provided so far.
Robert Martell: You know, obviously, we take safety extremely seriously and are always saddened when a patient, passes.
Obviously, we take safety extremely seriously and are always saddened when a patient passes.
Robert Martell: And that's, you know, the reason why we, you know, have looked very closely at this particular, case where this patient on this study eventually did pass.
And that's the reason why we.
Has looked very closely at this particular case, where there's this patient on this study.
Essentially did pass.
Robert Martell: Let me give you a little bit of background on this.
Let me give you a little bit of background on this so this patient came on to study.
Robert Martell: So this patient came on to study, you know, with this therapy, a patient with AML, was, managed quite successfully on the study for over eight months. And in the ninth month of treatment, unfortunately, this patient declined fairly rapidly, was, admitted to the emergency department, and unfortunately, died rather quickly. We know that the patient, again, was managed successfully up until that point.
With this therapy in patients with AML.
Mismanaged quite successfully on the study.
For over eight months and are in the ninth month.
Treatment. Unfortunately, this patient decline fairly rapidly.
Was admitted to the emergency Department and Unfortunately died rather quickly.
We know that the patient again.
It was managed successfully up until that point, Unfortunately, when patients, possibly as such.
Robert Martell: Unfortunately, when patients pass away as such, many things are going on. They're at high risk for sepsis and other complications.
Many things are going on.
They are at high risk for sepsis and other complications and so part of what we wanted to do and what the FDA requested us.
Robert Martell: And so part of what we wanted to do and what the FDA requested us to provide information, on is, you know, all the details around that.
She will provide information on is all the details around that and so we.
Robert Martell: And so we, you know, are in those discussions in providing that level of detail to the agency.
In those discussions and providing that level of detail to the agency and I think it's also important to put this into context.
Robert Martell: And I think it's also important to put this into context.
Robert Martell: This is a patient with AML who had previously been treated with a hypomethylating agent.
This is a patient with AML, who had previously been treated with a hyper methylated agents and we know from the literature that the median survival of that patient population.
Robert Martell: And we know from the literature that the median survival of that patient population is only about two and a half months.
Is only about two and a half months.
Robert Martell: It's extremely short.
Robert Martell: So unfortunately, the natural history for these patients allows them just a couple months of survival.
Extremely short so unfortunately, the natural history for these patients.
Allows them just a couple of months of survival.
Robert Martell: And we know that this particular patient was in their ninth month of treatment.
We note that this particular patient was in the nine months of treatment.
And so you know we're treating a very serious population and so we think that it's important to put that context over this the.
Robert Martell: And so we're treating a very serious population.
The other main issue that Jim mentioned was the you know.
The dose selection so the FDA has become.
Robert Martell: And so we think that it's important to put that context over this.
Barry.
Concerned about.
Across the oncology.
Indications in.
All studies in fact, and we've seen this many times with other companies in recent times wanting to participate in the dose selection for the ultimate recommended dose going forward before pivotal trials.
Robert Martell: Another main issue that Jim mentioned was the dose selection.
Robert Martell: So the FDA has become very concerned across the oncology indications and all studies, in fact, and we've seen this many times with other companies in recent times, wanting to participate in the dose selection for the ultimate recommended dose going forward before pivotal trials.
I'll get to your question about.
Our path forward for registration in a minute.
Robert Martell: And I'll get to your question about our path forward for registration in a minute.
This is part of what they requested was.
Yeah.
A little bit further explanation about.
Dose choice and the appropriate dose to take patients forward now we know that in this study we.
Robert Martell: But this is part of what they requested was a little bit further explanation about dose choice and the appropriate dose to take patients forward.
We actually have three doses, where patients have had efficacy and that has cleared the safety hurdle.
On the study, meaning that they are below.
The.
Below the maximum tolerated dose so 200 milligrams 300 milligrams and 400 milligrams.
Robert Martell: Now, we know that on this study, we actually have three doses where patients have had efficacy, and that have cleared the safety hurdle on the study, meaning that they're below the maximum tolerated dose. So 200 milligrams, 300 milligrams, and 400 milligrams.
Robert Martell: We've provided them with a significant amount of data to sort through those different doses and the exposures.
We've provided them with a significant amount of data to sort through those different doses and the exposures and so that will be part of our discussion as well to.
Robert Martell: And so that will be part of our discussion as well to understand where we would move forward in pursuing a registrational trial.
I understand.
Where we would move forward.
In pursuing a registrational trial.
Robert Martell: And then just to get briefly to your last question on what is our regulatory path, again, in this situation, there is not a lot, actually nothing formally available for patients.
And then just to get briefly to your last question what is our regulatory path.
Again in this situation there is not a lot actually nothing formally available for patients.
Robert Martell: Once patients have progressed following hypomethylating agents, really clinicians are left with only, you know, trying to give chemotherapy off the shelf, which is not necessarily approved in this indication.
Once patients.
Progressed following hyperventilating agents.
Clinicians are left with only.
Trying to give chemotherapy.
Off the shelf, which is not necessarily are approved in this indication.
Robert Martell: And the outcomes from this tend to be extremely poor, you know, nothing approved, you know, for these particular indications.
And the outcomes from this tend to be extremely poor.
Nothing approved.
For these particular indications so we think that this.
Robert Martell: So we think that this, you know, could be an opportunity for rapid development, perhaps accelerated approval.
Could be an opportunity for rapid development, perhaps accelerated approval. So we've discussed previously the possibility.
Robert Martell: So we've discussed previously the possibility of single arm study with response rate. We note that our reported response rate for AML post-HMA has been quite solid so far in the patients that we've treated.
A single arm study with response rate, we note that our reported response rates for AML post HMA.
Well it has been quite solid.
So far indications that we've treated and even in Mds, we've seen a very consistent reduction in blast count in the.
Robert Martell: And even in MDS, we've seen a very consistent reduction in blast count in, you know, the majority of patients achieving a marrow CR.
The majority of patients achieving a mere OCR. So we feel very encouraged.
Robert Martell: So we feel very encouraged.
Robert Martell: FDA is also, you know, recently desiring more comparative trials.
FDA has also.
Recently, desiring more comparative trials and so ultimately we hope to discuss it.
Robert Martell: And so ultimately, you know, we hope to discuss at some point in the near future our plan with the agency.
At some point in the near future our plan with the agency, we haven't specified our timeline yet for doing that.
Robert Martell: We haven't specified our timeline yet for doing that, but we will discuss both of those options as potential paths forward.
We will discuss both of those options as potential paths forward.
Li Watsek: Does that answer your questions, Lee?
Is that answered your questions yeah.
Thanks for the color I guess another question.
Oh, My God, it's kind of.
A combination of what we're gonna add.
I guess can you thank.
Thank you kind of move forward with 200, Meg or do you think you need to lure perhaps.
Hi, Laura Daily can you just share more talent to round this AP greater than 200 and Nick.
Li Watsek: Yeah, great.
Sure. So yeah. This is Jim again highly.
Li Watsek: Thanks for the color.
As Bob said, we are very fortunate were in this position, where we've got multiple doses of M. A asserted that appear to be both safe and effective.
Li Watsek: I guess another question, I guess, is on the dose for the combination with Iplutinib.
And our hope would be as the FDA reviews, the data whether it's whether we're looking at monotherapy or combo therapy. We are getting really strong responses in every single place where testing monotherapy and combination therapy AML with spliceosome M. B S with spliceosome ammo would flip three and lymphoma in NHL in cielo.
So the the performance of the drug is clear.
I hope that the FDA is going to agree with us that the risk benefit profile looks really quite attractive and that Amazon sort of App offers a novel way with a novel mechanism.
To give clinicians and their patients and extra tool that could be very valuable in addressing cancer of course. It is an expectation with project documents as Bob said the FDA is very interested in learning more about doses. Our hope would be that as I said theyre going to complete their review and they'll they'll come to where we are which is.
Li Watsek: I guess, do you think you can move forward with 200 mg, or do you think you need to explore perhaps a lower dose?
Li Watsek: And can you just share more details around the safety data at 200 mg?
Li Watsek: Sure.
The drug looks to be a really compelling novel alternative and that what really should happen is that we should be dosing more patients and learning more about those doses and proceeding with the next step in clinical development, but I don't want to get too far ahead of ourselves as I said, we're having discussions with FDA now and I hope that they'll come out in our in that.
James Dentzer: So, you know, this is Jim again.
Sort of positive place.
Okay, great. Thanks.
Ladies and gentlemen, this concludes our question and answer session I'd like to turn the conference call over to the company's President and Chief Executive Officer, James Dentzer for any closing remarks. Thank you Jamie and thank you everyone for joining today's call.
James Dentzer: Hi, Lee.
James Dentzer: Yeah, as Bob said, we are very fortunate.
James Dentzer: We're in this position where we've got multiple doses of Emobucertib that appear to be both safe and effective.
James Dentzer: And our hope would be, as the FDA reviews the data, whether we're looking at monotherapy or combotherapy, we're getting really strong responses in every single place we're testing, monotherapy and combination therapy, AML with spliceosome, MBS with spliceosome, AML with FLT3, and lymphoma in NHL and CLL.
James Dentzer: So the performance of the drug is clear. I hope that the FDA is going to agree with us that the risk-benefit profile looks really quite attractive, and that Emobucertib offers a novel way with a novel mechanism to give clinicians and their patients an extra tool that could be very valuable in addressing cancer.
James Dentzer: Of course, it is an expectation with Project Optimist.
James Dentzer: As Bob said, the FDA is very interested in learning more about doses.
James Dentzer: Thank you, Jamie, and thank you, everyone, for joining today's call.
And as always thank you to our patients and families participating in our clinical trials to our team of curious for their hard work and commitment and to our partners at origin, Amy next and the NCI for their ongoing help and support we look forward to updating you again soon.
James Dentzer: Our hope would be that, as I said, they're going to complete their review and they'll come to where we are, which is the drug looks to be a really compelling novel alternative and that what really should happen is that we should be dosing more patients and learning more about those doses and proceeding with the next step in clinical development.
James Dentzer: But I don't want to get too far ahead of ourselves.
James Dentzer: As I said, we're having discussions with FDA now, and I hope that they'll come out in that sort of positive place.
Li Watsek: Okay, great.
Operator: Thanks, Jim.
Operator: Ladies and gentlemen, this concludes our question-and-answer session.
James Dentzer: And, as always, thank you to our patients and families participating in our clinical trials, to our team at QRIS for their hard work and commitment, and to our partners at Origine, Immunext, and the NCI for their ongoing help and support.
James Dentzer: I'd like to turn the conference call over to the company's president and chief executive officer, James Dentzer, for any closing remarks.
James Dentzer: We look forward to updating you again soon.
Operator: Operator?
Operator.
Operator: The conference has now concluded.
The conference has now concluded we thank you for attending today's presentation. You may now disconnect your lines.
Operator: We thank you for attending today's presentation.
Operator: You may now disconnect your lines.