Q1 2021 Syndax Pharmaceuticals Inc Earnings Call
Ladies and gentlemen, thank you for standing by and welcome to these index first quarter 2021 earnings Conference call. At this time all participants are in a listen only mode. After the speaker presentation there'll be a question and answer session basket question. During the session you will need to press star one on your telephone please be advised that today's conference.
Operator: gentlemen, thank you for standing by, and welcome to the Syndax first quarter 2021 earnings conference call. At this time, I'll participate in turn a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you'll need to press Star 1 on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press Star Zero. I would not like to hand the conference over to your speaker today, Melissa Forst, from Argo Partners. Please go ahead. Thank you.
Is being recorded.
Squire any further assistance. Please press star Zero I would now like to hand, the conference over to your speaker today, Melissa Forst of Argot partners. Please go ahead.
Thank you welcome and thank you to those if you're joining us on the line and the webcast. This afternoon for the U S indexes first quarter 2021 financial and operating results.
Melissa Forst: Thank you. Welcome and thank you to those of you joining us on the line and the webcast this afternoon for a review of Syndax's first quarter 2021 financial and operating results with me this afternoon to discuss the results and provide an update on the company's progress. Dr. Briggs Morrison, Chief Executive Officer; and Daphne Carritas, Chief Financial Officer. Also joining us on the call today for the question and answer session will be Michael Metzker, President and Chief Operating Officer, Dr. Michael Myers, Chief Medical Officer, and Dr. Peter Ord Dentlick, Chief Scientific Officer.
With me this afternoon to discuss the results and provide an update on the company's progress are Dr. Briggs Morrison Chief Executive Officer.
Tony Curtis Chief Financial Officer.
Also joining us on the call today for the question and answer session will be Michael Metzger, President and Chief Operating Officer, Dr. Michael Meyers, Chief Medical Officer, and Dr. Peter or debt like Chief Scientific Officer.
Melissa Forst: This call is being accompanied by a slide deck that has been posted on the company's website. So I'd ask everyone to please turn to forward-looking statements on slide two. Before we begin, I would like to remind you that any statements made during this call that are not historical are considered to be forward-looking statements within the meaning of the Private Security Litigation Reform Act of 1995. However, actual results may differ materially from those indicated by these statements as a result of various important factors.
This call is being accompanied by a slide deck that has been posted on the company's website. So I'd ask everyone to please turn to forward looking statements on slide two.
Before we begin I would like to remind you that any statements made during this call that are not historical are considered to be forward looking statements within the meaning of the private Securities Litigation Reform Act of 1995.
Actual results may differ materially from those indicated by these statements as a result of various important factors. This income.
Melissa Forst: This includes those discussed in the risk factor section of the company's most recent quarterly report on Form 10Q, as well as other reports filed with the SEC. Any forward-looking statements represent our views as of today, May 11th, 2021. A replay of this call will be available on the company's website following the conclusion of the call. And with that, I'm pleased to turn the call over to Dr. Briggs-Morison, Chief Executive Officer of Syndax.
Those discussed in the risk factors section in the company's most recent quarterly report on form 10-Q, as well as other reports filed with the SEC.
Any forward looking statements represent our views as of today may 11th 2021 only.
A replay of this call will be available on the company's web site. Following the conclusion of the call and with that I'm pleased to turn the call over to Dr. Briggs Morrison, Chief Executive Officer Index.
Briggs Morrison: Great. Thank you so much, Melissa, and thank you to everyone for joining us on today's call via webcast. Slide 3 provides a high-level summary of our current corporate priorities as we strive to realize a future in which people with cancer live longer and better than ever before. We've continued to make great progress in both our clinical programs during the first quarter of this year. We reported the initial data from the Phase 1 trial of S&DX 5613, our selective Mennin inhibitor, and are on track to begin potential registration cohorts in that program shortly.
Oh, great. Thank you so much Melissa and thank you to everyone for joining us on today's call and the webcast.
Slide three provides a high level summary of our current corporate priorities as we strive to realize a future in which people with cancer live longer and better than ever before.
We've continued to make great progress both on clinical programs during the first quarter from this year.
We reported the initial data from the phase one trial of F. N. D. X 50, 613 are selective menin inhibitor and are on track to begin potential registration cohorts and that program shortly.
Briggs Morrison: In addition, we have completed enrollment of 23 chronic graph versus host disease patients on axiomab at one milligram per kilogram in our phase two expansion cohort, and enrollment is ongoing in our pivotal Agave 201 trial. We therefore remain on track to have two registrational programs ongoing this year for two first-in-class and potentially best-in-class medicines for two areas of important unmet medical needs. Thanks to the support of our many committed investors, we are well financed to vigorously pursue both of our existing programs and to aggressively look for additional opportunities to bring targeted oncology drugs into our pipeline.
In addition, we have completed enrollment of twenty-three chronic graft versus host disease patients on asset telematics at one milligram per kilogram in our phase II expansion cohort.
Enrollment is ongoing in our pivotal agave to a one trial.
We therefore remain on track to have two registrational programs ongoing this year for two first in class and potentially best in class medicines for two areas of important unmet medical need.
Thanks to the support of our many committed investors we are well financed to vigorously pursue both of our existing programs and to aggressively look for additional opportunities to bring targeted oncology drugs into our pipeline.
Briggs Morrison: Let's now turn to slide four in our recent data disclosure of our phase one trial of 5613, our selective menin inhibitor for the treatment of acute leukemia. As we noted in our recent data disclosure, in our phase one trial, 5613 has been well tolerated over multiple cycles with no patient discontinuing due to a drug-related adverse event. Our pharmacodynamic data confirms the mechanism of action, and perhaps most importantly, we have a candidate recommended phase two dose that meets all of our pre-specified criteria.
Let's now turn to slide four and our recent data disclosure of our phase one trial on 50 613 are selective menin inhibitor for the treatment of acute leukemia.
As we noted in our recent data disclosure in our phase one trial 50, 613 has been well tolerated over multiple cycles with no patients discontinuing for drug related adverse event.
Pharmacodynamic data confirms the mechanism of action and perhaps most importantly, we have a candidate recommended phase two dose that meets all of our pre specified criteria.
Briggs Morrison: We are, of course, excited to have also observed clear evidence of monotherapy activity in this population of patients, relapse to refractory acute leukemia with both MLLR and NPM-MLR and NPM 1C mutations, most responses being MRD negative. I want to reinforce why we are so excited about what we are seeing and provide additional data that further builds our confidence in our program.
We are of course excited to have also observed clear evidence of monotherapy activity in this population of patients with relapsed or refractory acute leukemia with both MLR and N. P. M on see mutations with most responses be <unk> negative.
I want to reinforce why we are so excited about what we are seeing and provide additional data that further builds our confidence in our program.
Briggs Morrison: Let me first remind everyone that this is a phase one trial, and patients have received, on average, three prior therapies. About 40% had relapsed after a bone marrow transplant, a very negative prognostic sign, and almost 60% had previously received venetac. These are very difficult to treat patients, and we were delighted to see a 48% overall response rate and 67% of the responses being MRD negative. Every physician currently treating acute leukemia who has reviewed this data with us has been excited by the efficacy we are seeing, and the data has only gotten better over the past weeks, with two patients converting to CR with full count recovery.
Let me first remind everyone that this is a phase one trial.
You should have received on average three prior therapies.
40% had relapsed after a bone marrow transplant very negative prognostic sign and almost 60% had previously she received phonetic lacks did.
These are very difficult to treat patients and we were delighted to see a 48% overall response rate.
67% of the responses being negative.
Every physician currently treating acute leukemia, who has reviewed this data with US has been excited by the efficacy we are seeing.
And the data has only gotten better over the past weeks with two patients converting to C. R with full count recovery.
Briggs Morrison: We pointed out that it is not uncommon for patients with complete eradication of leukemia to initially have incomplete recovery of their additional blood count, for recovery can take time. Slide 5 is a reprise of one of the vignettes we presented at our data disclosure event.
We had pointed out it is not uncommon for patients with complete eradication of leukemia to initially have incomplete recovery of their additional blood counts for recovery can take time.
Slide five is a reprise of what other than yes, we presented at our data disclosure event you'll.
Briggs Morrison: You will see here a patient with refractory NPM1C acute leukemia who was treated at our recommended phase two dose and had a rapid MRD negative CR. Initially, her blood counts had not recovered to normal, and she had a CRI, which is an MRD negative complete response with incomplete recovery of her blood count, but you can also see that over time, her blood counts fully recovered. She had an MRD negative CR with full blood count recovery and went on to potentially curative bone marrow transplants.
You'll see here of a patient with refractory N. P. M. One seat acute leukemia, who was treated at a recommended phase two dose and had a rapid <unk> negative CR.
Initially however, her blood counts had not recovered to normal and she had a cri, which is an M. R. D negative complete response with incomplete recovery of her blood counts.
But you can also see that over time her blood counts fully recovered.
She had an M already negative CR with full count recovery.
Went on to potentially curative bone marrow transplant.
Briggs Morrison: At the time of our data disclosure, we noted that five patients had already achieved either a CR or a CRH and that there were five patients still ongoing who had an MRD negative CR but had not yet achieved a CR or CRA. We anticipated that some of those patients would have full count recovery over time, and that's exactly what we have seen. Over the ensuing weeks, two of the patients who had an MRD negative CR but had not yet achieved a CR or CRH, have now had full count recovery and now have achieved a CR and remain non-study.
At the time of our day to disclosure, we noted that five patients had already achieved either a CR or CRH and that they were five patients still on going who had an M. R. D negative CR, but had not yet achieved CR or CRH we.
We anticipated that some of those patients would have full count recovery over time, and that's exactly what we have seen.
Over the ensuing weeks two of the patients who had an M. R. D negative CR, but had not yet achieved a CR or CRH have now had full count recovery and now have achieved a CR and remained on study.
Briggs Morrison: The third patient of the five who had an MRD negative CR but had not yet achieved a CR or CRH has improved from a CRA to a CRP and also remains on study. Of the two remaining patients, one remains on study with a response of CRP, and one is off-studied due to progressive disease.
A third patient of the five who had an <unk> negative CR, but had not yet achieved a CR CRH has improved from our cri two of CRP and also remains on study.
On the two remaining patient one remains on study with a responsive CRP and one is off study due to progressive disease.
Briggs Morrison: Slide 6 shows the response data we presented on April 20th, as well as the updated data as of last Friday. Let me repeat that these data on slide six are from our ongoing phase one trial. This data on slide six is a snapshot in time, and the data may further improve.
Slide six shows the response data we presented on April 20th as well as the updated data as it was last Friday.
Let me repeat that these data on slide six our from our ongoing phase one trial.
This data on slide six is a snapshot in time and the data may further improve there are still two patients on trial, who have had an M. <unk> negative CR, but have not yet achieved a CR or CRH.
Briggs Morrison: There are still two patients on trial who have had an MRD negative CR, but have not yet achieved a CR or CRA. We are looking carefully at the patient characteristics with respect to any potentially appropriate adjustments to our enrollment criteria in our upcoming phase two study. We understand the regulatory precedent for the efficacy hurdle for the approval of 5613 in relapsed and refractory acute leukemia. While there are no guidelines on a specific rate that is required for approval, we have pointed out the rates that were reported for recently approved FLT3 and IDH inhibitors that suggest the CR plus CRH rate above 20% has been acceptable to the FDA, phase one data that we've generated from our ongoing Augment 101 trial, and again, I want to emphasize it is our data that gives us confidence that 5613 will achieve that level of efficacy in our upcoming phase two trial.
We are looking carefully at the patient characteristics with respect to any potentially appropriate adjustments to our enrollment criteria in our upcoming phase two study.
We understand the regulatory precedent for the efficacy hurdle for the approval of 50 613 in relapsed or refractory acute leukemia.
There are no guidelines on a specific rate that is required for approval.
We have pointed out the rates that were reported for recently approved flit three NID H inhibitors that suggest a CR plus CRH rate above 20% has been acceptable to the FDA.
The phase one data that we've generated from our ongoing augment one on one trial and again I want to emphasize it is our data that gives us confidence that 50, 613 will achieve that level of efficacy in our upcoming phase two trial.
I also want to provide a broader context about what we are seeing in the N. P. M. One population.
Briggs Morrison: I also want to provide a broader context about what we are seeing in the NPM 1 population, as we believe it's quite informative and supports our confidence that the efficacy in the NPM1 population should mirror that of the MLLR population. For the avoidance of doubt, we reported that we had treated seven relapsed or refractory patients with NPM1C acute leukemia, and there were two patients with a CR. Of the remaining five patients, one progressed quite rapidly on the third day of treatment, and two had clear evidence of antilochemic activity, but unfortunately, they succumbed to a systemic infection, one of the feared complications of acute leukemia prior to attaining a bone marrow response.
We believe it's quite informative and supports our confidence that the efficacy and the N. P. M. One population should mirror that of the MLR population.
For the avoidance of doubt we reported that we had treated seven relapsed or refractory patients with N. P. M on see acute leukemia, and there were two patients with a CR.
Of the remaining five patients one progressed quite rapidly on the third day of treatment and two had clear evidence of anti leukemic activity, but unfortunately succumb to a systemic infection. What are the feared complications of acute leukemia prior to attaining a bone marrow response.
Briggs Morrison: We believe the totality of our clinical data suggests, therefore, that as predicted from the preclinical data, 5613 will have good activity in patients with NPM 1C acute leukemia as well. Slide 7 shows our Go Forward plans for 5613.
So we believe the totality of on clinical data suggests therefore that as predicted from the preclinical data 50 613, we'll have good activity in patients with N. P M on see acute leukemia as well.
Slide seven shows our go forward plans for 50, 613th we.
Briggs Morrison: We anticipate initiating phase two at the end of this quarter and holding our end of phase one meeting with FDA shortly thereafter. We also anticipate a further update of the Augment 101 data at the end of this year, and will, of course, also look for additional opportunities to provide meaningful updates as events allow. The phase two portion of the trial will enroll three distinct expansion cohorts, patients with MLLR acute lymphoid leukemia, ALL, patients with MLR acute myeloid leukemia, AML, and patients with NPM 1 mutant AML. The phase two portion will enroll both pediatric and adult patients, thereby providing us with a potential path to regulatory approval with a broad label, including both adults and pediatric patients. I should note that the results are positive.
Initiating phase II at the end of this quarter.
Holding our end of phase one meeting with FDA shortly thereafter.
Also anticipate a further update on the augment 101 data at the end of this year and will of course also look for additional opportunities to provide meaningful updates as events allow.
The phase two portion of the trial will enroll three distinct expansion cohorts patients with MLR acute lymphoid leukemia, a L. L patients with MLR acute myeloid leukemia AML.
And patients with N P M on it.
Now.
The phase two portion will enroll both pediatric and adult patients, thereby providing us a potential path to regulatory approval with a broad label, including both adults and pediatrics.
I should note that the results are positive this phase II portion of augment one on one could potentially support a regulatory filing.
Briggs Morrison: This phase two portion of Augment 101 could potentially support a regulatory filing given existing regulatory press. However, we do not yet have a final endorsement of our phase two sample size, nor have we finalized our enrollment rate, and yet it is possible that we could have top-line data for one or more of the cohorts sometime next year. Over the last period, we've also been conducting extensive research into the broad landscape of clinical opportunities for 5613 beyond the initial approval in relapse refractory acute leukemia, as illustrated on slide 8. However, we are not in a position today to lay out the specific next steps in building out the 5613 franchise.
On an existing regulatory precedence.
We do not yet have a final endorsement of our phase two sample size, nor have we finalized our enrollment rate.
Yes. It is possible that we could have top line data for one or more of the cohorts sometime next year.
Over the last program has also been conducting extensive research into the broad landscape of clinical opportunities for 50 613 beyond the initial approval in relapsed refractory acute leukemias as illustrated on slide eight.
We are not in a position today to lay out the specific next steps in building out. The 50 613 franchise I can say that we are using this ongoing analysis to inform a specific combination regimens that we anticipate starting to study later this year.
Briggs Morrison: I can say that we are using this ongoing analysis to inform specific combination regimens that we anticipate starting to study later this year. Additionally, several investigators and leading companies have already reached out to us with novel, exciting ideas for future development of 5613, and we are evaluating those opportunities. Let me now turn to slide 9. and Axitilab, a potentially best-in-class monoclonal antibody targeting the CSF1 receptor. As you know, we presented our Phase 1 Chronic Graph versus Host Disease data at Ash in December of last year.
Several investigators at leading companies have already reached out to us with novel exciting ideas for future development 50, 613, and we are evaluating those opportunities.
Let me now turn to slide nine and actually tell them at our potentially best in class monoclonal antibody.
Targeting the CSF one receptor.
As you know we presented our phase one chronic graft versus host disease data at Ash in December of last year.
Briggs Morrison: You may recall that we opened a phase two expansion cohort at the one milligram per kilogram dose, and we are pleased to announce that that cohort has now been fully enrolled. We anticipate presenting later this year the full updated data from both 17 patients from the phase one portion of the trial, as well as the 23 patients enrolled in the phase two expansion cohort at the one mig per Kig dose.
Recall that we had opened a phase two expansion cohort at the one milligram per kilogram dose.
We are pleased to announce that that cohort has now been fully enrolled.
We anticipate presenting later this year the full updated data from both 17 patients from the phase one portion of the trial as well as the 23 patients enrolled in the phase two expansion cohort at the one Meg per kg dose.
Briggs Morrison: I should emphasize that our base assumption is that this one-mig-kig dose will be our labeled dose, and hence the phase two expansion cohort is quite relevant as a derisking event for the eventual outcome of our pivotal trial.
I should emphasize that our base assumption is that this one big per kg dose will be our label dose and hence the phase two expansion cohort is quite relevant as a derisking event to the eventual outcome of our pivotal trial.
Briggs Morrison: Slide 10 outlines our pivotal trial for acetylamab and chronic graft versus host disease. This trial is the Axitinilab for graft versus host disease trial called Agave 201. This trial is enrolling patients with chronic graft versus host disease whose disease has progressed after two prior therapy. Patients must be at least six years of age and have met overall entry criteria. This is a pivotal dose-ranging trial in which patients will be randomized to one of three treatment groups, each investigating a distinct dose of acetylamab given either every two weeks or every four weeks. The primary endpoint is overall response rate using the 2014 NIH consensus criteria for chronic grapefruit. Secondary endpoints will include duration of response and validated quality of life assessments using the least symptom scale.
Slide 10 outlines our pivotal trial for us to tell them that chronic graft versus host disease.
This trial is the acetyl lab for graft versus host disease trial called a Gaba a 201.
This trial is enrolling patients with chronic graft versus host disease, whose disease has progressed after two prior therapies.
This must be at least six years of age and have met overall entry criteria.
This is a pivotal dose ranging trial in which patients will be randomized to one of three treatment groups.
Investigating a distinct dose of acts until a mab given either every two weeks or every four weeks.
Primary endpoint is overall response rates using the 2014 NIH consensus criteria for chronic graft versus host disease.
Secondary endpoints will include duration of response and validated quality of life assessments using the least symptom scale.
Briggs Morrison: Enrollment in the study is underway, and we are on track to deliver top-line data in 2023. We believe that chronic graph versus host disease represents a high unmet medical need and an important commercial opportunity, with approximately 14,000 patients suffering from chronic graft versus host disease in the U.S. today. With the recent positive pivotal results from both Insights Jackify and Cadmins KD-O-25, we may soon see regulatory approvals and commercial launches that will begin to delineate the commercial opportunity in chronic grapher's host.
Enrollment to the study is underway and we are on track to deliver top line data in 2023.
We believe that chronic graft versus host disease represents a high unmet medical need and an important commercial opportunity with approximately 14000 patients suffering from chronic graft versus host disease in the U S. A day.
With the recent positive pivotal results from both insights Jakafi and CAD minutes. Katy 025, we may soon see regulatory approvals and commercial launches that will begin to delineate the commercial opportunity in chronic graft versus host disease.
Briggs Morrison: Despite recent advancements in this area, to our knowledge, Axlomab is the only agent in clinical development that specifically targets the monocyte macrophage lineage. We believe the data generated to date with Acetylomab suggests that it has the potential to play an important role in the treatment of chronic graft versus host disease, both as monotherapy and, given its safety profile, potentially in combination with complementary medicine. We've also been working extensively with experts in the field of fibrodic disease, and I found a strong consensus that the scientific rationale for the efficacy of acetylomab in chronic graft versus host disease firmly supports its potential in a wide variety of fibrodic diseases, such as idiopathic pulmonary fibrosis and scleroderm.
Despite recent advancements in this area to our knowledge ex till them out as the only agent in clinical development that specifically targets the monocyte macrophage lineage.
We believe the data generated to date with acetyl on map suggests that has the potential to play an important role in the treatment of chronic graft versus host disease.
Both as monotherapy and given its safety profile potentially in combination with complementary medicines.
We've also been working extensively with experts in the field of fibrotic disease and they found a strong consensus that the scientific rationale for the efficacy of Axa telematics and chronic graft versus host disease firmly supports its potential in a wide variety of fibrotic diseases, such as idiopathic pulmonary fibrosis scleroderma.
We are actively evaluating options by which to build the ax Telemark franchise beyond chronic graft versus host disease and take advantage of what we believe are significant set of opportunities that could materially enhance shareholder value.
Briggs Morrison: We are actively evaluating options by which to build the axiomize franchise beyond chronic graph versus host disease and take advantage of what we believe are a significant set of opportunities that could materially enhance shareholder value. As we have previously communicated, we obtained orphan drug designation from the FDA for the use of acetilab in IPF. Finally, slide 11 summarizes transactions that led to the acquisition of the MLR program and the Axotelama
As we have previously communicated we obtained orphan drug designation from the FDA for the use of backfill on that and I P. F.
Finally, slide 11 summarizes transactions that led to the acquisition of the minimum MLR program and the act to tell them that program.
Briggs Morrison: We believe that we will be able to continue to expand our pipeline through the acquisition or in-licensing of quality differentiated assets. We believe that we have the necessary skills to evaluate and identify high-quality assets and the clinical development experience to bring these compounds through valuable inflections. We expect to remain among preferred partners in such transactions. I will now turn the call over to Daphne to review our financial results. Thank you.
Believe that we will be able to continue to expand our pipeline through the acquisition or in licensing of quality differentiated assets.
We believe that we have the necessary skills to evaluate and identify high quality assets and the clinical development experience to bring these compounds through valuable inflection points, we expect to remain among preferred partners of such transactions.
I will now turn the call over to Daphne to review our financial results.
Daphne Carritas: Thank you, Brig. The results of our operations for the first quarter of 2021 and the comparison to the prior year's quarter are included in our press release, so I won't repeat them in these remarks. Additional financial details are available in our first quarter report on Form 10-Q, which was filed earlier today. I would like to point out that our net loss for the quarter was $27.7 million or $54 per share compared to $19.1 million or $56 per share for the $2.6 billion. same period last year.
Thank you Greg.
Both of our operations for the first quarter of 2021, and the comparison to the prior year quarter are included in our press release, so I won't repeat them on these remarks.
Additional financial details are available on our first quarter report on form 10-Q, which was filed earlier today I would like to point out that our net loss for the quarter was $27 7 million or 54 cents per share compared to $19 $1 million or 56 cents per share from the same period last year.
Daphne Carritas: Turning to Slite 12, we ended the first quarter with $271.3 million in cash and cash equivalence and 51.6 million shares and pre-funded warrants outstanding. This cash balance provides us cash runway into 2023 and importantly, covers the development costs of Axitlamab and the men in registristical programs to their first approval, as well as provides us the flexibility for continued business development. Looking ahead, I'd like to provide financial guidance for the second quarter of 2021.
Turning to slide 12, we ended the first quarter with $271 $3 million in cash on cash equivalent and 51 6 million shares and pre funded warrants outstanding. This cash balance provides a cash runway into 2023, and importantly covers the development cost.
The act to tell on that and the men in registration on programs to their first approval as well it provides us the flexibility for continued business development.
Looking ahead I'd like to provide financial guidance from the second quarter of 2021 for the second quarter, we expect R&D expense to be between 30 and $35 million and total operating expense to be between 35 and $40 million, including approximately $2 5 million of noncash.
Daphne Carritas: For the second quarter, we expect R&D expense to be between $30 and $35 million, and total operating expense to be between $35 and $40 million, including approximately $2.5 million of non-cash stock compensation expense. Full Year 2021 guidance remains unchanged, and we continue to expect R&D expense to be between $90 and $100 million and total operating expense to be between $110 and $120 million, including approximately $2.5 million of non-cash stock comp expense per quarter. We continue to expect first half expenses to be more heavily weighted than the second half due primarily to the ramp-up in CMC activities for both programs in the first half of the year.
Stock compensation expense.
Well your 2021 guidance remains unchanged and we continue to expect R&D expense to be between 90 and $100 million on total operating expense to be between 110 on a $120 million, including approximately two and a half million of noncash stock comp expense per quarter.
We continue to expect first half expenses to be more heavily weighted on the second half due primarily to the ramp up in CMC activity from both programs in the first half of the year.
Briggs Morrison: With that, I would now like to turn the call back over to Brick.
With that I would like to now turn the call back over to Brad.
Briggs Morrison: Thanks so much, Daphne. Let me close the call by again noting that we have begun the registrational trial for Axetilab in chronic graft versus host disease and are on track to start the registrational program for 5613 shortly. This management team has been focused on obtaining regulatory approval for drugs that extend and improve the lives of people with cancer, and we consider having two ongoing registration programs as a major achievement. We are also increasingly excited about the broad franchise opportunities for both programs beyond their initial registrational indications. We believe 5613 could have broad utility across a wide range of clinical settings in acute leukemia, and acetylamab could represent a broad franchise opportunity in fibrootic disease.
Thanks, so much Stephanie.
We close the call by again, noting that we have begun the registrational trial for acts of telematics.
In chronic graft versus host disease and are on track to start the red cells Registrational program for 50 613 shortly.
This management team has been focused on obtaining regulatory approval for drugs that extend and improve the lives of people with cancer and we consider having two ongoing registration programs is a major achievement.
We are also getting increasingly excited about the broad franchise opportunities for both programs.
On their initial registrational indications.
We believe 50 613 could have broad utility across a wide range of clinical settings in acute leukemia, and I have to tell them app could represent a broad franchise opportunity and fibrotic diseases.
Briggs Morrison: We are comfortable, given our cash on hand, that we have the financial resources to aggressively advance our programs and achieve key upcoming milestones. We remain optimistic that we can continue to identify and bring in novel molecules to deepen our portfolio. We have a proven track record of delivering on this pillar of our strategy, and I believe it is a core strength of our company. As always, I'd like to thank the wonderful talented team here at Syndax, our collaborators, and, most importantly, the patients, the trial sites, and the investigators involved in our clinical programs. In addition, I'd like to thank our committed long-term investors who are helping us to build this great company. With that, I'd like to open the call to questions.
We are comfortable with given our cash on hand that we have the financial resources to aggressively advance our programs and achieve key upcoming milestones.
We remain optimistic that we can continue to identify and bring in novel molecules to deepen our portfolio and a proven track.
Track record of delivering on this pillar of our strategy and I believe it is a core strength of our company.
As always I'd like to thank the wonderfully talented team here at syntax, our collaborators and most importantly, the patients trial sites and investigators involved with our clinical programs.
In addition, I'd like to thank our committed long term investors, who are helping us to build this great company.
With that I'd like to open the call for questions.
Thank you as a reminder to ask a question you will need to press star one on your telephone to withdraw.
To your question personal time on key please standby on compile the Q&A roster.
Operator: Thank you. As a reminder, to ask a question, you'll need to press Star 1 on your telephone. To withdraw your question, press the panel key. Please stand by with the PILNA roster. Our first question comes from Phil and Nadu at the accounting company. You may proceed with your question.
Our first question comes from film Naidu with Cowen and company. You May proceed with your question.
Good afternoon, thanks for picking on our questions and congratulations on the progress.
First a clarifying question on the good day to that you released Tonight in terms of the N. P. M on Ah patients in the 29% overall response rate have you disclosed whether the two responders have had complete hematologic recovery.
Philip M. Nadeau: Good afternoon. Thanks for taking our questions and congratulations on the progress. First, a clarifying question on the data that you released tonight. In terms of the NPM 1 patients in the 29% overall response rate, have you disclosed whether the two responders have had complete hematologic recovery?
So so one of the two N P. M. On patients is just been yet that I covered today and was one of the three vignettes that eight on covered so that patient clearly had a necessarily a cri and then had full hematologic coverage went on to it a bone marrow transplant.
Briggs Morrison: So one of the two NPM1 patients is the vignette that I covered today and was one of the three vignettes that Aiton covered. So that patient clearly had a CRI and then had full hematologic recovery and went on to a bone marrow transplant. We have not given any further information on the second patient who had a complete response.
We have not given any further information on the second patient who had a complete response.
Got it Okay second question.
It's in regards to the phase two dose. Many people have noted that recently another cohort was added to the dose escalation study looking at corpus that boosting.
Can you talk about the goals.
Philip M. Nadeau: Got it. The second question is in regards to the phase two dose. Many people have noted that recently another cohort was added to the dose escalation study looking at Kobysostat boosting. Can you talk about the goals for that cohort and how that plays into your decision on which dose to move into the pivotal study? Okay.
For that cohort and how that plays into your decision on which dose to moving to the pivotal study.
Yeah. Thanks for the question so the Codexis will start on it really.
On an exploratory arm.
To look at the effect of COVID-19 has sat on the PK of 50 613.
It has nothing to do with the doses that we wont take into phase two.
Briggs Morrison: Yeah, thanks for the question. So the cobasisat arm is really an exploratory arm to look at the effect of cobasistat on the PK of 5613. It has nothing to do with the doses that we will take into phase two. We're not waiting for data from the COBacistat arm to start phase two. So phase two is the data set that we presented at our data disclosure, so the 226 in RMA and the 113 in R&B. COBACISISISO status, really, as I said, an exploratory sort of lifecycle management study just to look at the PK, the effect of COBA's Sysic stat on the PK of 5613.
We're not waiting for the data from Nicole. This is this that arm to start phase III.
<unk> phase two.
It was the data set that we presented at our data disclosure. So that 220 ships in RMA and a 113 and our B a couple.
Simple status right.
Flower tortilla sort of lifecycle management studies just to look at the PK. The effect of COVID-19. This is that on the PK of 56.
Perfect.
Last question from Us I'm curious if you'd be willing to address it on I guess the biggest.
Prospect, we got after the initial dose was people who were worried that the therapeutic window of 50 613. It was a bit too narrow that could push the dose just a little bit harder maybe the efficacy would improve a bit brokerage, perhaps are somewhat limited by but Q T C prolongation at higher doses.
Philip M. Nadeau: Perfect. The last question for Muz, I'm curious if you'd be willing to address it. I guess the biggest pushback we got after the initial dose was people who were worried that the therapeutic window of 5613 was a bit too narrow, that if you could push the dose just a little bit harder, maybe the efficacy would improve a bit, but perhaps you're somewhat limited by QTC prolongation at higher doses. What's your perspective on that argument? How valid is it, and what gives you confidence that you're maximizing efficacy at the doses that are acceptably safe?
What's your perspective on that that argument how about what is it and what gives you confidence that that you're.
You're maximizing efficacy with the doses that are acceptably safe.
Yeah. So as we indicated in the presentation, we had prespecified.
Criteria for a recommended phase II dose.
Including our exposures that we thought were required for efficacy we have been able to meet those criteria at the recommended phase two dose.
Briggs Morrison: Yeah, as we indicated in the presentation, we had pre-specified criteria for our recommended phase two dose, including exposures that we thought were required for efficacy. And we were able to meet those criteria at the recommended phase two dose. The response rates at the recommended phase two dose are generally the same as what we see in the overall population, which is not all that surprising since many of the patients, in fact, were treated at the recommended phase two dose.
Response rates at the recommended phase two dose or generally the same as what we see in the overall population, which again is not all that surprising since many of the patients in fact were treated at the recommended phase two dose.
Again, the vignette I just presented today.
As a patient treated at the recommended phase two dose and N P. M on disease rapid C. R.
Just then progressed to full count recovery. So we feel very comfortable that the dose that we're picking for our recommended phase two dose meets our criteria and that we're not leaving any efficacy on the table by not going higher.
Briggs Morrison: Again, the vignette I just presented today is a patient treated at the recommended phase two dose who had NPM1 disease, a rapid CR, I that then progressed to full-count recovery. So we feel very comfortable that the dose that we're picking for our recommended phase two dose meets our criteria and that we're not leaving any efficacy on the table by not going higher.
That's very helpful. Thanks for taking our questions.
Yes.
Thank you on the next question comes from Bert Hazlett with BTG. You May proceed with your question.
Yeah.
Thank you just answered it. Thank you for taking the questions and congratulations on the progress I think you just answered it but maybe just a slightly differently.
Philip M. Nadeau: That's very helpful. Thanks for taking our question.
Operator: Thank you. Next question, Councillor Bert Hazlett with BTIG. You may proceed with your questions.
So what are the specific goals of the interim cohort.
Bert Hazlett: Yeah, I think you just answered it. Thank you for taking the questions and congratulations on the progress. I think you just answered it, but maybe just asked it slightly differently.
Interim dose cohort.
And is that a gating item to moving forward into the potential pivotal.
Bert Hazlett: So what then are the specific goals of the interim cohort, the interim dose cohort? And is that a gating item to moving forward into the potential pivotal start on 5613? Yeah, thanks for the question, Bert.
Start of 50 613.
Yeah. Thanks for the question Bert so.
As I said to Phil we're very comfortable with the dose that they are.
<unk> to 'twenty six on day 113 RMB.
As a recommended phase two dose the investigator.
Briggs Morrison: So, as I just said to Phil, we're very comfortable with the dose, the 226 ArmA-113 R-B, as the recommended phase two dose. The investigators and our clinical team wanted to study that intermediate dose to see if, in fact, there was a dose in between the doses we had studied that could also meet our criteria. If those intermediate doses do meet all of our criteria, they could be the doses that we take into phase two.
Investigators in our clinical team.
Wanted to study that intermediate dose to see if in fact, there was a dose them between the doses. We have studied that could also meet our criteria. If those intermediate doses do meet arkwright all of our criteria they could be the doses that we take into phase II.
They don't it's not a problem.
Briggs Morrison: If they don't, it's not a problem. So those are the gates. We do want to wait to get the answer to that question before we start the phase two trial. And again, we feel like we're on track to have that by the end of the quarter. Okay, that's it for me. Thank you.
So those are a gating, we do want to wait to get the answer to that question before we start.
The phase two trial and again, we feel like we're on on track to have that by the end of the quarter.
Okay. That's it from me thank you.
Thank you. Our next question comes from colleague Gucci with Baird. You May proceed with your question.
Operator: Thank you. Our next question comes from Colleen Couthey with Baird. You may proceed with your question.
Hi, good afternoon.
Colleen Couthey: Hi, good afternoon. Thanks for taking our questions and congratulations on the progress. For the clear, thanks for the clarity on the NPM 1 patients; I know you noted that two of them succumbed to infections. Did you see any of those in the MLR patients involved in the study?
Thanks for taking my question and congrats on the progress on.
For the.
Yeah.
For the claret. Thanks, Thanks for the clarity on the N. P. M. On patients I know you you noted the two of them to come to infection did you see any of those in the MLR patients enrolled in the study.
I don't remember off the top my head I think it was one of our patient.
Briggs Morrison: I don't remember off the top of my head. I think there was one MRI patient. Maybe Michael Myers, you can answer that question. I think there was one MLR patient who didn't make it through because of an early infection. But, Michael?
Maybe it might come on or as you can answer that question on if it was one of them a lot of patients who didn't make it through.
And early infection, but I call.
Yes Briggs. Thank you for that Colleen, yes, we have seen M. L L. Our patients.
Briggs Morrison: Yeah, Briggs. Thank you for that, Colleen.
Michael Werner Schmidt: Colleen, yes, we have seen MLLR patients have infections. It is an expected complication of AML, especially in patients who have active disease, whose counts are not sufficient to protect them from specifically bacterial infections. So, as Aton Stein said in the presentation, In fact, complications of AML are expected and not at all unusual.
B.
<unk> infection is an expected complication of AML, especially in patients who have active disease.
Pounds are are not sufficient to protect them from specifically bacterial infections. So as etan Stein said in the presentation.
Infectious complications of AML are expected and are not at all unusual.
Colleen Couthey: That's helpful, thank you. And what is the protocol for stem cell transplants in this study? And will there be any changes for phase two?
That's helpful. Thank you and what is it what does the protocol for stem cell transplants in the study and will there be any changes for the phase two.
Well there isn't a protocol for stem cell transplant in this study.
Briggs Morrison: Well, there isn't a protocol for stem cell transplantation in this study. The standard of care for the treatment of acute leukemia is if you can get a patient into a complete response, and particularly if you can get a patient into an MRD-negative complete response, and the patient is otherwise eligible for a transplant, meaning they have identified an adequate donor, and their other general medical conditions are stable, then the patient goes to transplant.
The.
Standard of care.
For the treatment of acute leukemia is if you can get a patient into a complete response and particularly if you can get a patient into an <unk> negative complete response.
And the patient is otherwise eligible for a transplant. Many they have identified an adequate donor or are there. Other general medical conditions are stable then the patient goes transplant. So it's the investigator.
Briggs Morrison: So it's the investigator and the treating physician's decision about whether they want to take them to transplant. What they're hoping for is that they can get the patient into an MRD negative complete response, and if so, then they will look to take the patient to transplant. This is formally part of our phase one study, but it is obviously a very good result for the patients who are able to go to transplant.
And the treating physician decision about whether they want to take them to transplant, but what they're hoping for is that they can get the patient into an <unk> negative complete response and if so then.
They they will look to take to based on the transplant it's not.
Formerly part of our phase one study, but it is obviously a very good result for the patients who are able to go to transplant.
That's great. Thanks, and then for.
Colleen Couthey: That's great. Thanks. And then for the updated data today, can you confirm that those were centrally reviewed, or how were those reviewed? So they were reported to us.
For the updated data today, I guess can you confirm where those centrally reviewed or how are those reviewed.
But there are reported to us by the.
Briggs Morrison: So they're reported to us by the, they aren't scans that you centrally review as you do for solid tumors. So the information is communicated to us by the investigator; Michael and his team review the information to confirm it.
They are <unk>.
Cans that use centrally review as you do for solid tumors. So the information is communicated to us by the investigator and then Michael and his team review the information to confirm it.
Great. That's helpful. Thank you.
Operator: Thank you. Our next question comes from Peter Lofsen with Barclays. May I proceed with your question?
Okay.
Thank you. Our next question comes from Peter Lawson with Barclays. You May proceed with your question.
Alright.
Peter Richard Lawson: Right. Congratulations on the progress and the update. 15613. Is there any way of breaking out the CR, CR rate for the, I guess, the 113 milligrams? Go forward, Do.
Congrats on the progress.
Right.
Yep.
13.
Is there any way of breaking out the C on CR rate for the I guess the.
115 milligram.
Go forward dose.
Briggs Morrison: Yes, Peter, I think you know, we're looking for opportunities to present the data at scientific congresses. We'll break out everything by dose and arm. So I think you can look forward to that updated scientific presentation. Is it, could you disclose if it's above or below the overall CR? Yeah, as I said before, if you look at any of the parameters that we've reported on, overall response rate, CR, CRH, the responses in NPM1, the responses in MLLR, at the recommended phase two dose, those responses are generally consistent with what we reported for the overall population
Yeah.
Yes, Peter I think the.
There will be on looking for opportunities to present, the data at scientific Congresses, well breakout everything by.
Dose arm.
I think you can look forward to that.
Added up update at a scientific presentation.
Is it could you disclose if it's above or below the overall C O CRH rate.
Yeah. So as I've said before if you look at any of the parameters that we've looked we've reported on overall response rate.
Here CRH.
Hum.
On the responses in N P M on the responses and all are at the recommended phase two dose those responses are generally consistent with what we reported for the overall population.
Briggs Morrison: Gotcha, and then just on the additional arm that was added. Just if I could circle back on that, would that be something you'd want to file on with a CIP-3-84 kind of on board? Just trying to work through the, if that's something that gets reported out in two years' time, or it's something you kind of have to perhaps use as a
Got you. Thank you and then just on the additional that was added just if I could circle back on that.
That would be something you were born on file them with a grateful kind of on board.
Trying to work through the if that's.
Sometimes it gets reported out in two years' time, or it's something you kind of.
Moving to perhaps use as our go forward strategy.
Peter Richard Lawson: use it as a go-forward strategy.
Briggs Morrison: Right, so as I indicated, I think Phil's question is not a gating item for phase two. You know, we will proceed with the doses that we've been talking about for phase two. This is really an exploratory arm as part of our sort of life cycle management. You know, we are thinking down the road to the point where we get patients in remission, who then, perhaps, from a maintenance point of view, If we can have a greater exposure for any given dose, that obviously decreases the cost of goods, but it's really more of a downstream life cycle as we're thinking about long-term chronic therapy, and it really Gotcha, that's really helpful. So it could be in that maintenance setting where you
Right. So as I indicated I think in sales question.
It's not a gating item for phase two.
We will.
Proceed with the doses that we've been talking about for phase. Two this is really an exploratory arm part of it.
Exploratory arm as part of our sort of lifecycle management.
We are thinking down the road to the point, where we get.
Patients in remission, who then perhaps in a maintenance point of view.
If we can.
We have greater exposure for any given dose.
And that obviously decreasing the cost of goods, but it's really more of a downstream lifecycle.
And we're thinking about it.
Long term chronic therapy and it really doesn't play a role in the ongoing phase phase one to phase III transition.
Got you. Thank you that's really helpful. So it could be in that maintenance setting, where you kind of extend the drug into.
Peter Richard Lawson: kind of extend a drug into post-therep. Exactly.
Most post therapy.
Briggs Morrison: Exactly. Perfect. Thank you so much.
Exactly.
Thank you so much.
Operator: Thank you. Our next question comes from Justin Walsh with B. Riley Securities. He may proceed with his question.
Thank you. Our next question comes on adjusted Walsh with B Riley Securities. You May proceed with your question.
Justin Walsh: Hi, thanks for taking the question. A couple of months ago, a competitor announced that it was using MRD negative CR as a primary endpoint for its drug and newly diagnosed NPN1 mutant AML. First, do you have any comments on how this endpoint is different and may not impact your thinking for the regulatory strategy for S&DX 5613? And second, how do you see the targeted NPN1 mutant AML landscape evolving with the potential for multiple therapies available for the population? I will guess, and thanks so much for your question.
Hi, Thanks for taking the question a couple of months ago, a competitor announced that its using <unk> negative CR as a primary endpoint for its drug and newly diagnosed MTN. One mutant AML first do you have any comments on how this endpoint is different in bay or may not impact your thinking for the regulatory strategy for SMB X 50, 613 and <unk>.
How do you see the targeted MTN, one you didnt AML landscape evolving with the potential for multiple therapies available for the population.
I guess it takes so much for your question. So the first has to do with EMR day negativity added as an endpoint.
Briggs Morrison: So the first has to do with MRD negativity as an endpoint. You know, we give a lot of credit to our competitor who has brought that forward and apparently gotten FDA endorsement to use that as an endpoint for accelerated approval in a randomized trial. To our knowledge, that as an endpoint in a single-arm trial, in a relapse or fractory population, it's not something the agency hasn't been open to date. Obviously, something for further regulatory discussions.
You know we gave.
A lot of credit to our competitor who has brought that forward and apparently gotten FDA endorsement to use that as a K.
A endpoint for accelerated approval in a randomized trial.
To our knowledge that that as an endpoint in a single arm trial.
And I relapsed refractory population is not something the agency hasnt been opened to date.
I see something for further just for the regulatory discussions.
Briggs Morrison: So I think that that is a... is probably not something we're going to be, we'll discuss with EFTA, but we're not counting on that being an endpoint for our relapse-refractory population. But similar to what they've described, we do think that could be an endpoint in a, let's say, a first-line trial where you use that as your accelerated approval endpoint. I think your second question about the landscape for NPM1 disease, you know, I think there's, obviously we believe that the men inhibition pathway, the men inhibitors are going to be very important agents for those patients. Whether there'll be other agents that work for those patients as well, time will tell. I have one more question.
So I think that that is a.
It is probably not something that we're going to be.
It will have to discuss with you today, but we're not counting on that being an endpoint for a relapsed refractory population, but a similar to what they've described we do think that could be an endpoint in a.
That's the first line trial, where you use that as their accelerated approval endpoint.
I think your second question about the landscape for N P M on disease.
I think there is.
Obviously, we believe that day in the Menin inhibition pathway.
<unk> inhibitors are going to be very important agents for those patients.
Whether there'll be other agents that that worked for for those patients as well time will tell.
Got it and I have one more question.
Justin Walsh: You mentioned the potential approvals in CGB, but I was wondering if you could provide some additional color in your thoughts on the landscape there. Do you anticipate that most of the VHD patients wind up cycling through all of the available drugs, or do you think that they'll remain on one drug for a long period of time, and there'll be a lot of competition in the first and second line on that? Yeah, it's a good question.
You've mentioned the potential approvals and see gvhd, but I was wondering if you can provide some additional color on your thoughts on the landscape. There do you anticipate that most of the gvhd patients wind up cycling through all of the available drugs or do you think that they'll remain on one drug for a long period of time and there'll be a lot of competition.
And the first and second line on that front.
Yeah, It's a good question.
Briggs Morrison: You know, I think the landscape in chronic graphers associates in infancy is sort of evolving. We haven't really had, you know, approved drugs. There's not a defined treatment pathway for patients. If you go on this one, then that one, we also think that different agents may have better efficacy for different manifestations of the disease. So I think it's something that we'll sort of see how that evolves. But, you know, I think we're quite excited to have an agent that shows broad activity against many manifestations of the disease.
I think the landscape in chronic graft versus associated with it.
It's infancy is sort of evolving.
We haven't really had.
Approved drugs there is not a defined treatment pathway for patients. So if you go on this one then that one.
We also think that different agents may have.
That's a better efficacy for different manifestations of the disease. So I think it's on it's something that we'll well sort of.
See how that evolves, but you know what.
I think we're quite excited to have an agent that shows broad activity against many manifestations of the disease and of course is the only one that's targeting macrophages I think the other part to you.
Briggs Morrison: And, of course, it's the only one that targets macrophages. I think the other part to your question about how this landscape will evolve is, are there rational combinations that, perhaps, even earlier in the treatment course, you could have a more profound effect on the patient's disease? Got it. Thanks for taking the questions.
Your question about how this landscape will evolve as either rational combinations that perhaps even earlier in the treatment of course, you can have a more profound effect on the patient's disease.
Got it thanks for taking my questions.
Operator: Thank you, and as a reminder, to ask a question, you'll need to press Star 1 on your telephone. Our next question comes from David Lieberwoods with Morgan Stanley. You may proceed with your question. Thank you.
Thank you and as a reminder to ask a question you will need to press star one on your telephone. Our next question comes from David Lebowitz with Morgan Stanley. You May proceed with your question.
Thank you very much for taking my question understanding.
David Lieberwoods: That's understanding that the number Yeah, I think, David, you're right, the numbers are on the small side. Most of the patients with MLLR that have come in have been AML patients. Again, one of the vignettes that Aiton reviewed at the day disclosure was a patient with what we call mixed phenotypic acute leukemia. Many people put that in, you know, in the ALL bucket.
Understanding that the numbers are somewhat limited at this point is there any qualitative insight you can give us as to the.
The effect of 5613 on a O L patients in the study.
Yeah, I think David you're right the numbers are on the <unk>.
Mall side, most of the patients with MLR that have come in had been AML patients.
Again, one of those vignettes that etan reviewed.
The other day disclosure, what the patient with what we call mixed phenotypic acute leukemia.
Many people bucket that in you know in the <unk>.
A L L bucket, but the so the numbers are small.
Briggs Morrison: But, so the numbers are small. I guess I'd say qualitatively that it looks the same in ALL as it does in AML, but the numbers are small. And as far as the, I guess, how does that Yeah, again, for relapse-refractory acute leukemia, for both NPM 1 and MLLR, there really aren't good treatments for these patients. So today, if they're truly relapse-refractory with either of those mutations, they're generally being treated with chemotherapy.
I guess I'd say to your question qualitatively it looks the same in a L. L. A doesn't AML, but the numbers are small.
Fair enough.
And as far as the M. P M. One Ah patients.
I guess, how does that 29% response rate look vis vis the the.
Response rates for the current standards in the similar treatment population.
Yeah, So again for relapsed refractory acute leukemia.
In for both N P M, one and MLR, there really arent good therapies for these patients. So today, if they're truly relapsed refractory with.
Briggs Morrison: And there's not a lot of really solid data on the response rate for those specific lesions, but overall, if you look in the relapse-refractory population, you'll see a response rate, again, a CR rate for chemotherapy probably no higher than 10%. So, you know, we think that what we're seeing both in NPM 1 and an MLR, again, with a safe oral agent, is probably quite an excess of what you would anticipate with and get another round of toxic chemotherapy.
With either of those mutations are generally being treated with chemotherapy.
And there's not a lot of really solid data on the response rate in for those specific lesions, but but overall if you look on the relapsed refractory population.
See a response rate again, a CR rate for chemotherapy, probably no higher than 10%.
Oh.
We think on what we're seeing both in N P. On one hand, and MLR again with a safe oral agent.
It's probably quite in excess of what you would anticipate with.
Yet another round of toxic chemotherapy.
David Lieberwoods: Thanks for taking my questions.
Thanks for taking my question.
Operator: Thank you, and I'm not showing any further questions at this time. I would like to turn the call back over to Dr. Morrison for any further remarks.
Thank you and I'm not showing any further questions. At this time I would now like to turn the call back over to Dr. Morrison for any further remarks.
Briggs Morrison: Great, thanks very much, Hopper. Thanks everybody for joining us on the call today. Again, I think we remain really quite excited about what we're seeing both with 5613 and with acetilamab, and we look forward to presenting additional data in the future. Thank you for joining us.
Great. Thanks, very much operator, and thanks, everybody for joining us on the call today again, I think we remain.
Really quite excited about what we're seeing both 50 613 and with that to tell them that and we look forward to.
Presenting additional data in the future. Thank you for joining.
Operator: Thank you, ladies and gentlemen. This concludes today's conference call. Thank you for participating. You may now disconnect.
Thank you ladies and gentlemen. This concludes today's conference call. Thank you for participating you may now disconnect.
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