Q4 2019 Earnings Call

Operator: Ladies and gentlemen, today's conference is scheduled to begin shortly. Please continue to stand by. Thank you for your patience. [inaudible] Go to Beadaholique.com for all of your beading supply needs!

Ladies and gentlemen, today's conference is scheduled to begin shortly please continue just standby. Thank you for your patience.

[music].

Operator: BF-WATCH TV 2021, Good day, everyone, and welcome to the Syndax Fourth Quarter 2019 Earnings Conference Call. Today's call is being recorded. At this time, I would like to turn the call over to Claudia Steislinger of Argo Partners. Please begin.

Claudia Steislinger: Thank you, Operator. Welcome, and thank you to those of you joining us on the line and the webcast this afternoon for a review of Syndax's fourth quarter and full year 2019 financial and operating results. I'm Claudia Steiflinger with Argo Partners, and with me this afternoon to discuss the results and provide an update on the company's progress are Dr. Briggs Morrison, Chief Executive Officer, and Rick Shea, Chief Financial Officer. Also joining us on the call today for the question and answer session are Michael Metzger, President and Chief Operating Officer, and Dr. Michael Myers, Chief Medical Officer. This call is being accompanied by a slide deck that has been posted on the company's website, so I would ask you to please turn to our forward-looking statements on slide 2.

Thank you operator, welcome and thank you to those of you joining us on the line and the webcast. This afternoon for a review of the DOCSIS fourth quarter and well your 2019 financial and operating result, I'm Claudius definitely are with Argot partners and with me this afternoon.

Discuss the results and provide an update on the company's progress or Dr. Briggs Morrison, Chief Executive Officer, and Rick Shea Chief Financial Officer also joining us on the call today for the question and answer session, Our Michael Metzger, President and Chief Operating Officer, Dr., Michael Myers, Chief Medical Officer.

This call is getting a company, but like I said, it's been could sit on the company's website. So would ask you to please turn to work were looking statements on sites you 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 19.

Claudia Steislinger: 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, including those discussed in the risk factors section of 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, March 3rd, 2020 only.

95 actual results may differ differ materially from those indicated by these statements as a result of various important factors, including those discussed in the risk factor section in the company's most recent quarterly report on form 10-Q, as well as other reports filed with that you see any forward looking statements represent.

Our views as of today March Threerd 2020, only a replay of this call will be available on the company's website Www Dot index dotcom. Following this call with that I'm pleased to turn the call ever to Dr. Briggs Morrison, Chief Executive officer ups and that Greg.

Claudia Steislinger: website www.syndax.com following this call. With that, I am pleased to turn the call over to Dr. Briggs Morrison, Chief Executive Officer of Syndax. Dr. Briggs.

Dr. Briggs Morrison: Thank you, Claudia. Thank you to everyone joining us on today's call and the webcast. 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 made great progress in 2019 on all three of our programs.

Thank you Claudia Thank you to everyone joining us on today's call and the webcast.

Three provides a high level summary of our current corporate priority as we strive to realize a future in which people with cancer live longer and better than ever before.

We made great progress in 20, Nineteena all three of our program since our last call in November of 2019, we have announced clinical data demonstrating proof of concept for the use of our anti CSF one hour antibody I could tell them out in the treatment of chronic graft versus host disease.

Dr. Briggs Morrison: Since our last call in November of 2019, we have announced clinical data demonstrating proof of concept for the use of our anti-CSF1R antibody, axitilumab, in the treatment of chronic graft-versus-host disease. We have announced two premier scientific publications that add to the compelling preclinical data supporting the potential of our menin inhibitor to be an effective therapy in acute leukemia, and we announced the addition of $55 million to our balance I think 2020 will be a tremendously exciting and transformative year for our company.

We've announced two premier scientific publication that add to the compelling preclinical data supporting the potential of our met inhibitor to be an effective therapy in acute leukemia, and we announced the addition of $55 million to our balance sheet.

I think 2020 will be a tremendously exciting and transformative year for our company.

Dr. Briggs Morrison: First, we know that the final overall survival readout of E2112 will occur this year, bringing us closer to a potential near-term FDA filing, approval, and launch for hormone receptor-positive metastatic breast cancer. Second, the Phase 1 Augment 101 trial of our highly selective, rationally designed menin inhibitor, SNDX5613, is underway, and we expect meaningful data from that program this year. And finally, we will continue to collect data that will further clarify the potential of our anti-CSF1R antibody, axotilumab, to treat chronic graft-versus-host disease. So let's review each of these opportunities in greater detail.

First we know that the final overall survival read out each 21 12 will occur this year, bringing us closer to a potential near term FDA filing approval and launch hormone receptor positive metastatic breast cancer.

Second the phase one augment one or one trial of our highly selective rationally designed met inhibitor SMB X 50, 613 is underway and we expect meaningful data from that program. This year.

And finally, we will continue to collect data that will further clarify the potential of our anti CSF one hour antibody until a map to treat chronic graft versus host.

So let's review each of these opportunities in greater detail.

Dr. Briggs Morrison: Slide 4 summarizes the design of the Phase 3 trial of antennastat in hormone receptor-positive, CUR2-negative breast cancer. The trial randomized 608 patients to eczemastain plus placebo versus eczemastain plus antennastat. And the focus of this trial is now on the final overall survival analysis. The final analysis will be conducted once there are 410 events, which, based on our modeling and recent discussions with ECOG, we believe will occur in the second quarter of this year.

Slide four summarizes the design of the phase three trial of antennas that hormone receptor positive hertwo negative breast cancer.

Trial randomized 608 patients to exit methane plus the Ti vo versus SMS team plus into this that and the focus of this trial is now on the final overall survival analysis.

One one ounces will be conducted once there are 410 events.

Which is based on our modeling and recent discussions with E. Cogs, We believe will occur in the second quarter of this year.

Dr. Briggs Morrison: A positive outcome would allow us to file for regulatory approval in the United States based upon the terms of our breakthrough therapy designation for hormone receptor positive metastatic breast cancer and the special protocol assessment process with FDA. Our team is prepared to submit a regulatory filing should the trial be positive, within about six months of receiving the data from e-cash, which would set us up to launch Intendostat in 2021. The trial has 80% power to detect a hazard ratio of 0.75. The maximum hazard ratio that would yield a statistically significant positive trial is 0.85.

Positive outcome would allow us to file for regulatory approval in the United States based upon the terms of our breakthrough therapy designation in hormone receptor positive metastatic breast cancer and the special protocol assessment process with the FDA.

Our team is prepared to submit a regulatory filing should the trial be positive within about six months of receiving the data from economy.

Which would set us up to launch into the stat in 2021.

Trial has 80% power to detect hazard ratio of 0.75, Maxim hazard ratios that would yield a statistically significant positive trial is 0.82.

Dr. Briggs Morrison: Based upon the design assumptions, if E2112 achieved a hazard ratio of 0.82, that would indicate that patients receiving the combination had about a five-month improvement in median overall survival or about 22 months in the Control Group to 27 months on the Internet. Slide 5 emphasizes the potential for the Intinastat-X and Mestane regimen to be the preferred agent after a first-line aromatase inhibitor, which is typically given either as a single agent or in combination with a CDK4-6 inhibitor. Our current estimate is that between 30% and 50% of the patients in E2112 will have received a CDK4-6 inhibitor prior to entering the trial. Thus, we should have a highly relevant data set in the post-CDK-4-6 patient population. In our opinion, the rapid adoption of CDK4-6 inhibitors, such as Ibran, in the first-line setting underscores the desire of physicians and patients to improve the outcomes associated with anti-estrogen therapy.

Based upon the design assumptions, if he 21 called achieved a hazard ratio as you're pointing to that would indicate that patients receiving the combination had about a five month improvement median overall survival for about 22 months.

And the control group to 27 month in the into this though.

Slide five emphasizes the potential for the into this that exit methane regimen to be the preferred agent. After a first line aromatase inhibitor, which is typically given either as a single agent or in combination with the CDK poor six.

Our current estimate is that between 30 and 50% of the patients in each 21 12, well have received CDK for six inhibitor prior to entering the trial.

Thus, we should have a highly relevant data set in the post CDK for six patient population.

In our opinion the rapid adoption of the CDK for six inhibitors, such as high brands in the first line setting underscores the desire physician and patient to improve the outcomes associated with anti Astrue there.

Dr. Briggs Morrison: In the setting of a positive E2112 result, we would expect Intendostat to achieve similar widespread use. This population of patients is substantial, with an estimated 34,000 patients in the U.S. each year who go on to receive hormone therapy after failing first-line therapy and who could therefore be eligible to receive the antinocet regimen. Importantly, we will be prepared to launch Intinistat in the U.S. on our own.

In this setting of a positive Etwenty 112 result, we would expect intend to stat to achieve similar widespread use.

Its population of patients is substantial with an estimated 34000 patients in the U.S. each year, who want to receive hormone therapy. After failing first line therapy into could therefore be eligible to receive due to that red.

Importantly, we will be prepared to launch into the stat in the U.S. on our own you're actively building out our internal commercial team to ensure we are well positioned for the potential launch of intend to step in 2021, well concurrently entering into discussions with potential rest of world commercial partner.

Dr. Briggs Morrison: We are actively building out our internal commercial team to ensure we are well-positioned for the potential launch of Intinistat in 2021, while concurrently entering into discussions with potential rest-of-world commercial partners. Slide 6 emphasizes the clinical potential of antennastat and hormone receptor-positive breast cancer. In preparation for launching into the market, we have conducted qualitative market research. We tested a conservative profile, essentially the minimum benefit that could provide a positive. We consistently heard from both groups of physicians that there is a high need for novel agents in hormone receptor-positive breast cancer and that they find the potential ability of antennastat to re-sensitize patients to endocrine therapy to be a very attractive feature of the drug. Not surprisingly We remain confident in the potential for E2112 to be a positive trial and are eager to bring this potentially new, important medicine to patients. Now, let me now turn to slide 7 and SNDX5613, our genetically targeted... Since our last call, two premier publications.

Slide six emphasizes the clinical potential of into this that hormone receptor positive breast cancer.

Preparation for launching into this that we have conducted the qualitative market research with community physicians and breast cancer expert.

Tested a conservative profile essentially the minimum benefit that could provide a positive or west result.

We consistently heard from both groups of physicians that there is a high need for novel agents in hormone receptor positive breast cancer that they find the potential ability other tenants that to re synthesize patient Anderson therapy to be at very attractive feature of the drug.

Not surprisingly the uniformly so overall survival as the most important efficacy endpoint and believe that an agent that could extend survival and lengthen the patients time on hormone therapy with minimal impact their quality of life made a very compelling profile.

We remain confident the potential for each 21 12 to be a positive trial in are eager to bring this potentially new important medicines to patients.

Let me now turn to slide seven and Essen Dx 50, 613 are genetically targeted agent.

Since our last call it two premier publication.

Dr. Briggs Morrison: This is a study that has been circulating related to menin inhibition. One in Cancer Cell, detailing the preclinical results of one of our molecules in MLLR leukemia, and one in Science, detailing the preclinical results of one of our molecules in NPM1 leukemia. These premier publications provide the scientific rationale and preclinical validation of our ongoing clinical trial, which is outlined on slide eight. The first in human trial in the Accelerated Understanding of Men and Inhibition, or AUGMENT program, is AUGMENT 101. The first inhuman clinical trial is a combined Phase I and Phase II trial. The Phase 1 portion is a dose escalation trial designed to identify the maximum tolerated dose and a recommended Phase 2 dose for SNDX5613. Patients with relapsed or refractory acute leukemia will be enrolled and will take SNDX5613 daily by mouth until they experience either progressive disease or unacceptable toxicity. The first 28 days of dosing will serve as the period in which safety is evaluated for determining dose escalation.

Circulated <unk> related to men in inhibition, one in cancer cell detailing the preclinical results of one of our molecules and MLL R. Leukemias and one in science detailing the preclinical results of one of our molecule and PMN one lucky.

He's premier publications provide the scientific rationale and preclinical validation of our ongoing clinical trial, which is outlined on slide eight.

The first in human trial in the accelerated understanding of men inhibition or augment program is augment one on one.

The first in human clinical trial has a combined phase one phase two trial.

The phase one portion is a dose escalation trial designed to identify the maximum tolerated dose and a recommended phase two dose for SMB X 50 613.

Patients with relapsed or refractory acute leukemia will be enrolled and we'll take Essen Dx 50, 613 daily by mouth until they experience as a progressive disease or unacceptable toxicity.

The first 28 days of dosing will serve as the period and would safety is evaluated for determining dose escalation.

Dr. Briggs Morrison: As required by the FDA, patients do not need to have specific genetic abnormalities in order to enroll in the Phase I study. The first cohorts follow an accelerated dose titration with only one patient required per treatment group. Upon encountering a pre-specified level of toxicity, the trial will convert to a standard 3 plus 3 design. We announced in the fourth quarter of last year that dosing had commenced, and the trial is progressing nicely. PK analysis is a key component of the Phase 1 trial. Our preclinical data indicates that the MNN-MLR interaction needs to be continuously inhibited in order to achieve optimal efficacy. We believe that safely achieving adequate target coverage in the Phase 1 trial could bode well for establishing efficacy in the Phase 2 trial.

As required by the FDA patients do not need to have to specific genetic abnormalities in order to enroll and the phase one study.

The first cohorts follow and accelerated dose titration with only one patient required per cohort upon encountering a pre specified level of toxicity that trial will convert to a standards replaced redesign.

We announced in the fourth quarter of last year that dosing Pac man and the trial is progressing nicely.

The PK analysis is a key key components of the phase one trial, our preclinical data indicates that the men M.L.R. interaction needs to be continuously inhibited in order to achieve optimal efficacy.

We believe that safely achieving adequate target coverage in the phase one trial could bode well for establishing efficacy in the phase two trial.

Dr. Briggs Morrison: We have been carefully examining drug exposure in patients to assess whether we are achieving adequate target coverage. Once a recommended phase 2 dose is established, the phase 2 trial will proceed to enroll three distinct expansion cohorts, each of which consists of a specific, genetically defined, relapsed, or refractory acute leukemia. The next three cohorts are adults with MLLR, acute lymphoid leukemia, ALL, adults with MLLR acute myeloid leukemia AML, and adults with NPM1 mutant AML. The Phase 2 portion will further characterize the safety of SNDX5613 and will provide an initial estimate of the complete response rate as a primary measure of therapeutic efficacy. We know that a lot of people, patients, physicians, and investors are eager to see the initial data from the Augment 101 trial.

We haven't carefully examining the drug exposure and patients is to assess whether we are deed achieving habit target coverage.

Once a recommended dose is phase two doses establish the phase two trial will proceed to enroll three distinct expansion cohorts each of which which consists of a specific genetically defined relapsed or refractory acute leukemia [noise].

Three cohorts are adults with MLL R acute lymphoblastic leukemia, AOL adults with MLL R acute myeloid leukemia, and mail and adults with MPM, one mute ammo phase two portion will further characterize the safety of Essen Dx 50, 613, and we'll provide that enough.

<unk> estimate of the complete response rate as the primary measure therapeutic benefit.

We know that a lot of people patients physicians and investors are eager to see the initial data from the augment one on one trial.

Dr. Briggs Morrison: We expect to report initial clinical data from the trial in the fourth quarter of this year. Given that Augment 101 is an open-label trial, meaningful interim data including PK, PD, or efficacy may be available earlier. In addition, we are eager to advance this molecule into the pediatric population. It's a key component of our overall strategy. We will have more to say about the details of the pediatric timing and approach on a future call. We know that pediatric leukemias with MLR rearrangements represent a significant unmet need.

We expect to report initial clinical data from the trial in the fourth quarter of this year.

Given that augment one on one is an open label trial meaningful interim data, including PK PD or efficacy maybe available earlier in the year.

In addition, we are eager to advance this molecule into the pediatric population, it's a key component of our overall strategy.

More to say about the details of the pediatric timing and approach on a future call.

We know that pediatric leukemias with NLRB arrangements represent a significant unmet medical need and were eager to work with the pediatric oncology community to bring Essen Dx 50 613 to their page.

Dr. Briggs Morrison: Syndax Pharmaceuticals Inc. Based upon preclinical data and the underlying biology of the pathway, we are expecting evidence of single-agent activity. As a result, there could be a rapid and straightforward clinical development path for 5613, perhaps like the path taken for agents addressing patients with FLT3 or IDHD. As we continue to learn more about the potential of 5613 in acute leukemia, we see this molecule becoming an additional and important value driver. Now, we turn to slide 9 and SNDX6352, our potential best-in-class monoclonal antibody targeting the CSF1 receptor. Let me first note that we now have a generic name for this molecule, acetylamide, and going forward, we will refer to this molecule by this generic name and retire the SNDX 6352 designation.

Based upon pre clinical data and the underlying biology that pathway, we are expecting evidence of single agent activity.

As a result, there could be a rapid and straightforward clinical development path or 50, 613, perhaps like the path taken for agents addressing patients with three or IDH mutation.

As you continue to learn more about the potential of 50 613 in acute leukemia, we see this molecule, becoming an additional an important value driver for Sunday.

Let me now turn to slide nine and Essen Dx 63, 52, our potential best in class monoclonal antibody targeting the CSF one receptor.

Let me first note that we now have a generic name for this molecule I said telematics and going forward, we will refer to this molecule with this generic name and retire the S and X 63 52 designation.

Dr. Briggs Morrison: We are conducting a trial testing Actilimab as monotherapy in chronic graft-versus-host disease. Chronic graft-versus-host disease is a frequent complication of hematopoietic stem cell transplantation, wherein donor-derived immune cells contribute to the initiation and development of fibrosis in the myriad manifestations of this disease. In preclinical models, blockade of the CSF1-CSF1R pathway with anti-CSF1R antibodies can result in the depletion of donor macrophages, thereby preventing and reducing chronic, And we believe that chronic graft-versus-host disease represents an important clinical opportunity.

We are conducting a trial testing I can tell a map as monotherapy chronic graft versus host city.

Chronic graft versus host diseases, a frequent complication of amount of politics stem cell transplantation, wherein donor derived immune cells contribute to the initiation and development of fibrosis married manifestations of this disease.

In preclinical models blockade of the CSF one.

CSF, one our pathway with anti CSF, one our antibodies can result in the depletion of donor macrophages, thereby preventing and reducing chronic graft versus host.

We believe that chronic graft versus host disease represents an important clinical opportunities.

Dr. Briggs Morrison: At the end of last year, we released initial data from our Phase 1 trial, which is diagrammed on slide 10. The Phase 1 portion is a dose escalation trial designed to identify the maximum tolerated dose and a recommended Phase 2 dose of acetilumab for the treatment of chronic graft-versus-hostility. We have released data from the first five patients enrolled in the first three cohorts and have now modified the trial to include a phase two cohort at one milligram per kilogram. We will continue the Phase 1 trial to more formally define the recommended Phase 2 dose and may open one or more additional Phase 2 dose cohorts as well. Slide 5 shows the results seen in the first five patients as of mid-December.

At the end of last year, we released initial data from our phase one trial, which is diagram on slide 10.

The phase one portion is a dose escalation trial designed to identify the maximum tolerated dose and a recommended phase two dose back until a map for the treatment chronic graft versus host.

We have released data from the first five patients enrolled in the first three cohorts and have now modify the trial to include a phase two cohorts at the one milligram per kilogram dose.

We will continue the phase one trial to more formally define the recommended phase two dose and and make opened one or more additional phase two dose cohorts as well.

Slide five reprise as a result seen in the first five patients as of mid December only four of which of the patients were evaluable for response as of that data cut off.

Dr. Briggs Morrison: four of which.

Dr. Briggs Morrison: All of those patients were valuable for response as of that data cutoff. Our investigators are quite excited to see clinical activity at all doses and the initial results suggest good durability of the drug. Slide 12 is a picture that brings home the impact this medication is having on the disease. As we've discussed the specific results with experts in fibrotic diseases, they have commented on the improvement in both inflammation, you can see the redness subsiding, and the benefit in improving the ulcers as well. We are now considering exploring several additional inflammatory and fibrotic diseases for axitomabs, and we'll have more to say about that in a future class.

Investigators are quite excited to see clinical activity at all doses and the initial results suggest good durability of effect.

Slide 12, as a picture that brings home the impact medication is having on the disease.

As we've discussed this specific results an expert in byproduct diseases. They have commented on the improvement in both inflammation you can see the redness society and the benefit in improving the ulcers as well.

We are now considering exploring several additional inflammatory anti fibrotic diseases, perhaps until that we'll have more to say about that in a future call.

Dr. Briggs Morrison: Finally, slide 13 summarizes the transactions that led to the acquisition of the Mennon MLLR and the SNDX 6352 program. 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 clinical development expertise to bring these compounds through valuable inflection points and expect to remain among the preferred partners of such transactions. Now, I'll turn the call over to Rick to review our finances.

Finally, slide 13 summarizes the transaction that led to the acquisition of the mm Mandan MLL R. Andi guess mdx 63, if due to program.

We believe that we will be able to continue to expand our pipeline through the acquisition or in licensing of quality differentiated app.

We believe that we have the necessary clinical development expertise to bring these compounds through valuable inflection point and expect to be me remain among the preferred partners a such transaction.

I'll now turn the call over to Rick to review our financial results.

Rick Shea: Thank you, Briggs.

[noise]. Thank you break.

Rick Shea: The results of our operations for the fourth quarter of 2019, and for the full year, and the comparison to the prior year quarter and year are included in our press release, so I won't repeat them in these remarks.

The results of our operations from the fourth quarter 2019.

And for the full year and the comparison prior year quarter in year are included in our press release.

I won't repeat them and these remarks additional financial details will be available in our quarterly or annual report on form 10-K, which we intend to file this week.

Rick Shea: Additional financial details will be available in our quarterly and annual report on Form 10-K, which we intend to file this week. Turning to slide 14, we ended 2019 with $59.8 million in cash and 31.6 million shares of pre-funded warrants outstanding. The net change in cash for the fourth quarter was a decrease of $12.5 million. The net loss for the quarter of $14 million was offset by non-cash stock compensation expense of $1.5 million.

Turning to slide 14, we ended 2019 with $59.8 million in cash and 31.6 million shares and pre funded warrants outstanding.

Net change in cash for the fourth quarter was a decrease of 12 and a half million dollars.

Net loss for the quarter of $14 million was offset by noncash stock compensation expense of one and a half million <unk> million dollars.

Rick Shea: Looking ahead, I'd like to provide financial guidance for each of the first two quarters of 2020. Our financial guidance for the second half of 2020 will be issued after we get the results of the E2112 study. We expect our operating expenses for the first two quarters of 2020 to increase over the quarterly operating expenses we reported for the second half of 2019. R&D expenses will increase primarily due to increased development activities for SNDX5613, our menin inhibitor, and for axotilumab, our anti-CSF1R antibody. We do expect GNA expenses also to increase, primarily due to increased antennastat pre-commercial activity, for the first and second quarters of 2020. We expect R&D expenses to be $12 to $14 million per quarter, and total operating expenses to be $17 to $19 million per quarter.

Looking ahead I'd like to provide financial guidance for each of the first two quarters of 2020.

Financial guidance for the second half 2020 will be issued after we get the result of the 21 12 study.

We expect our operating expenses.

For the first two quarters of 2020 to increase over the quarterly operating expenses, we reported for the second half of 2019.

R&D expenses will increase primarily due to increased development activities for Sn Dx 50, 613, our men and inhibitor.

And for X. until a map our anti CSF one our antibody.

We do expect DNA expenses also to increase primarily due to increased in tennis that pre commercial activities.

For the first a each of the first and second quarters with 2020.

We expect R&D expenses to be $12 million to $14 million per quarter, and total operating expenses to be $17 million to $19 million per quarter.

Rick Shea: That includes approximately $1.5 million per quarter of non-cash stock compensation expense. The cash at year-end was about $60 million, and in Q1 2020, we added $35 million through an equity financing. And we drew $20 million of debt on a term loan. So our pro forma cash headed into 2020 is $115 million, and given our cash operating expense guidance for the first half of 2020. We expect to end Q2 2020, the first half of 2020, with more than $80 million in cash, which gives us the financial flexibility to take advantage of key development milestones well into 2021.

That includes approximately one and a half million dollars per quarter of noncash stock compensation expense.

A cash at year end was about $60 million.

And in Q1, 2020, we added $35 million through an equity financing.

And we drew $20 million.

Yet on a term loan so our pro forma cash headed into 2020 <unk>.

As a $115 million and given our cash operating expense guidance for the first half of 2020.

We expect to end Q2, 2021st after 2020.

More than $80 million of cash, which gives us the financial flexibility to take advantage of key development milestones well into 2021.

Dr. Briggs Morrison: I'll now turn the call back over to Briggs.

I'll now turn the call back over to Greg.

Dr. Briggs Morrison: Thanks very much, Rick. As I hope you've appreciated from my prepared remarks, 2020 is a busy year for Syndax with several very important and exciting data readouts close at hand. We believe that a positive OIS result in E2112 would be transformative for Syndax and create significant shareholder value. We anticipate a final readout in the second quarter.

Thanks, very much Rick.

I hope Youve appreciated from my prepared remarks, 2020 is busy year first index was several very important and exciting data readouts close at hand.

We believe that a positive Oh I see result in a 21 12 would be transformative for syndax and create significant shareholder value.

We anticipate a final read out in the second quarter of this year.

Operator: We also believe that SNDX5613, our Menin MLLR inhibitor, is well-poised for near-term proof-of-concept data. We believe that safely achieving adequate target coverage in the Phase 1 trial could de-risk this program with single-agent activity in patients with either MLLR or NPM1 mutant leukemia, providing clinical proof-of-concept and enabling early regulatory clarity and planning for next steps. And finally, we're very excited about the early results we are seeing with hexapilimab and chronic graft-versus-host disease and look forward to presenting updated data from this program at the end of the year. With our recent, highly successful financing, we are comfortable that we have the financial resources to get us through these key upcoming miles. Finally, we are optimistic that we will continue to identify and bring in novel molecules to deepen our portfolio.

We also believe that SMB X 50, 613, our men MLL R inhibitor is well poised for near term proof of concept data.

We believe that safely achieving adequate target coverage in the phase one trial could de risked this program with single agent activity in patients with either MLL R or NPM, one mute leukemia, providing clinical proof of concept and enabling early regulatory clarity and planning for next step.

And finally, we're very excited about the early results, we are seeing with X telematic chronic graft versus host disease and look forward to presenting updated data from this program at the end of this year.

Our recent highly successful financing we're comfortable that we have the financial resources to get us through these key upcoming milestones.

Finally, we are optimistic that we will continue to identify and bring in novel molecules to deepen our portfolio you have a proven track record of delivering on pillar of our strategy and I believe this is a core strength of our company.

Operator: We have a proven track record of delivering on this pillar of our strategy, and I believe this is a core strength of our company. As always, I would like to thank the wonderful talented team here at Syndax, our collaborators, and, most importantly, the patients, trial sites, and investigators involved in our clinical program. In addition, I'd like to thank our committed long-term investors who are helping us build this great company and to welcome the new investors who have joined in that effort with our recent findings. With that, I'd like to open the call to questions.

As always I would like to thank the wonderfully talented team here at Synnex, our collaborators and most importantly, the patients trial sites and investigators involved with our clinical program.

In addition, I'd like to thank our committed long term investors, who are helping us build this great company and to welcome the new investors, who joined in that effort with our recent fine.

With that I'd like to open the call for questions.

Madhu Sudhan Kumar: Thank you. As a reminder, if you'd like to ask a question, please press star then 1 on your touchtone telephone. To withdraw your question, press the pound key. Please stand by while we compile the Q&A list. Our first question comes from Madhu Kumar with Baird. Your line is now open. Okay guys, thanks for taking our questions. So, thinking about the chronic graft-versus-host disease program, would you imagine the expansion cohort will still require a bunch of pre-treated patients?

Thank you as a reminder, if you'd like to ask a question. Please press Star then one on your Touchtone telephone to withdraw your question press the pound key please standby when we compile the culinary roster.

Our first question comes from my <unk> Kumar with Baird. Your line is now open.

Okay guys. Thanks for taking our question so thinking about the chronic graft versus host disease program would you imagine the expansion cohort will still require a brutal pretreated patients or do you imagine that it will be it kind of wider swag graft versus host population.

Dr. Briggs Morrison: www.kenhub.com Yeah, Madhu, it will be a wider population of patients. As you recall, when we first started the trial, we were required to be post-ibrutinib. But that inclusion criteria has been softened considerably, so now it is a wider population.

Yeah, I do it might do it will be a wider population of patients as your call. We first started the trial we were required to be post type revenues that are inclusion criteria has been softened considerably. So now it is a wider populations of patients.

Okay, and then thinking about the the men and MLL program in terms of PK and PD data would you wait to get to dose limiting toxicities were now kind of Teekay you data or would you want to if you saw that activity that looks like we're getting good continue or Matt.

Dr. Briggs Morrison: Okay, and then thinking about the MEN and MLL program, in terms of TK and TD data, would you wait to get to dose-limiting toxicity to announce any kind of TK or TD data, or would you want to, if you saw an activity that looked like it was getting good continual MEN and MLL inhibition and good kind of pharmacokinetics, you'd want to report that ahead of really completing the dose limitation?

No not allow inhibition in good kind of pharmacokinetics that you'd want to report that ahead of really completing the dose escalation.

Dr. Briggs Morrison: Yeah, again, as I pointed out in my prepared remarks, Madhu, I think there are PK, PD, and efficacy. If we had a sufficient number of patients that we feel like we've actually adequately characterized the PK and dose proportionality and the ability to cover the target, and let's say we had that in advance of a significant number of patients with efficacy data, we could potentially present that PK.

Yeah, I get as I pointed out in my prepared remarks on the do I think theres PK PD and efficacy.

If we had at a sufficient number of patients that we feel like we've actually adequately characterize the PK and dose proportionality any ability to cover the target.

And let's say, we had that in advance of.

A significant number of patients where that's because you did it we could potentially present that PK data.

Okay. That's me thank you yes.

Madhu Sudhan Kumar: Okay, that's it for me. Thank you, guys. Thank you. Our next question comes from Bert Hazlitt with VTIG. Your line is now open.

Thank you. Our next question comes from Bert Hazlett with BTG. Your line is now open.

Once again, our next question comes from Bert Hazlett <unk>, Yeah, one my apologies.

Bert Hazlitt: Once again, our next question comes from Bert Hazlitt, BT01. My apologies. I'm intrigued by the commercial launch preparation discussions that are underway. Could you just remind us, assuming success in 2112, what the gating items would be for, first of all, the filing and then actually the commercialization of it?

I'm intrigued by the commercial launch preparation discussions that are underway could you just.

Remind us assuming success and 21 12, the gating items would be for our first of all the filing and then actually commercialization of it.

Dr. Briggs Morrison: Right, so let me first take the filing piece, and then I'll turn it over to Michael to talk about some of the commercial work. So, as I said in my prepared remarks, we anticipate that within about six months of getting the data from ECOG, we would be in a position to submit the NDA, and then, you know, it would depend on FDA decisions on the timing of how long that review would take, but our base assumption is we'd be in a position to launch the product in 2021. And then maybe I'll turn it over to Michael just to give a couple of comments on how we're getting ready commercially to be prepared for that.

Right. So Bert let me first take the filing piece now I'll turn it over to Michael to talk about some of that commercial work. We're doing so as I said in my prepared remarks, we anticipate that.

Within about six months of getting the data from E. Cogs, we would be in a position to submit the.

D.A. and then we would depend on FDA decision on or whether the timing of how long that review would take but our base assumption as we we'd be in a position to launch the product in 2021.

And then maybe I'll turn it over to Mike will just to give a couple of comments on and how we're getting ready commercially to to be prepared for that right or its I think as Bruce mentioned in his prepared remarks Precommercialization work is a focus for US has been for some time and we'll continue with that through getting data and.

Michael A. Metzger: Right, so as Briggs mentioned in his prepared remarks, pre-commercialization work is a focus for us, has been for some time, and we'll continue with that through getting data and then up to a potential launch. Obviously, putting together the commercial team and the leadership around a commercial launch in the U.S. is important, so we'll be working hard on that. Hiring the field force in the U.S. We talked about launching the drug and being prepared to launch the drug on our own in the U.S., so that will require, of course, a focused field force to do that. And lastly, finding a partner for XUS will become a priority for us as well, so we can have a global launch of the product and do so optimally.

Up to a potential launch obviously, putting together the commercial team in the leadership.

Around a commercial launch of the U.S. is important so we'll be working hard on that hiring to feel for us to the U.S., we had talked about launching the drug and be prepared to launch the drug on our own in the U.S. So that will require of course of focused feel forced to do that.

Lastly, finding a partner for ex us will become a priority for us as well. So we can have a global launch of the product do so optically, but the all those all those workstreams or sort of in process and it will be augmented around the time of day.

Michael A. Metzger: But all those work streams are sort of in process and will be augmented at the time of day. Can you remind us how advanced the, excuse me, breakthrough designation in the US, but the path to potential acceptance of the 2112 data by the EU or other regulatory authorities, and how advanced those discussions are for the rest of the world?

You want us how advanced the.

Give me a breakthrough designation in the U.S., but the the path to potential acceptance of the 21 12 data.

Why do you or other regulatory authorities and how.

Advance those discussions are for rest of the world.

Dr. Briggs Morrison: I think from a regulatory point of view, having a trial that shows improved overall survival relative to a standard second or third-line agent is a registrable package in the EU. We have not had very recent discussions with them from a regulatory point of view, and our intent would be to do so once we have the results of the trial. As I said, I think we will be prepared to launch the drug ourselves in the U.S., but we are concurrently looking for a commercial partner who can help us with the launch outside the U.S.

Right. So then I hate to that for its Greg So I think from a regulatory point of view.

Having a trial that shows improved overall survival relative to a standard second or third line agent. We think is a.

Registrational package in the U.

We have not had a very recent discussions with them from a regulatory point of view and are intended to be to do that once we have the results of the trial.

As I said I think we would we will we prepared to launch the drug ourselves in the U.S., but we are currently looking for a commercial partner, who can help us with the launch outside the U.S.

Okay.

Bert Hazlitt: Okay, just shifting to 5613 briefly, do you expect the low doses to be able to constantly inhibit the menin-MLR interaction?

Shifting to 50 613 briefly.

Do you expect the low doses to be able to constantly inhibit the men MLL or interaction.

Dr. Briggs Morrison: Yeah, so again, as you know, we're always trying to project The CK exposure is based upon what you saw pre-clinically. Based upon those projections, it is possible that, Even at the early dose escalations, we would have sufficient coverage. But I think it goes back to Madhu's question of, you know, seeing enough of that PK data to feel comfortable that we... Based upon modeling from preclinical work into what we think will be PK in humans, it's possible that at one of those early dose levels, we should be able to cover the target pretty well.

Yes. So again you as you know where you always trying to.

Project PK exposures based upon what you saw a pre clinically.

Based upon those projections it is possible that even at the early dose Escalations, we would have sufficient coverage.

But I think it goes back to my do his question as you know seeing enough of that PK data to feel comfortable that we can we can cover the target, but based upon modeling from preclinical work into what we think will be PK in humans. It's possible that one of those early dose levels, we should be able to cover the target pretty well.

Bert Hazlitt: Terrific. We're looking forward to the data. Thanks. Thank you. Our next question comes from Ed White with HC Wadenright.

Terrific looking forward to the data thanks.

Thank you. Our next question comes from Ed White with H.C. Wainwright. Your line is now open.

Ed White: Your line is now open. Hi, thanks for taking my question. So, just a question on acetylsamide.

Hi, Thanks for taking my question. So just a question on ACA till the Matt.

I was just wondering if you have the.

Dr. Briggs Morrison: I was just wondering if you had the third patient in COPORT 3 was not evaluated yet as of the data update. We have to wait until the end of the year to see that patient updated. Also, you can tell us how many patients have been enrolled in COPORT 4 and in Phase 2 and what we should be expecting to see when you do release the data later this year. Thank you.

<unk>.

The.

Finally, the third patient cohorts three was not valuated, yet, but it's up to do the update.

Well, we have to wait to the ended the year the speed that.

That patient the updated and also.

Tell us how many patients have been a role than pro forma for and in the phase two and what should be expecting to see when you do released the data later this year. Thank you.

Ed White: Thanks for your question. The short answer is yes, but you will have to wait until the end of the year. We don't think it's that useful for people for us to regularly update the data. I think, in general, what you should think about for the end of the year is the completion of the Phase I portion of the trial, studying various doses and dose schedules and some number of patients on the expanded one milligram per kilogram dose. I don't think we've really guided how many, but I think by the end of the year, we should have a good number of patients in that expanded cohort as well as the completion. We think the best way to update people on the profile, you know, the emerging profile, is at an appropriate medical conference. So, that's why we guided towards the fourth quarter of this year, presenting that update.

Yeah. Thanks for your question short answer is yes, you will have to wait till the end of the year. We're not we don't think it's.

That useful for people for us to you know regularly sort of update the data. So I think in general what you you should think about for the ended the year is the completion of the phase one portion of the trial studying various doses and dose schedule and you know some number of patients on the expand.

Added one milligram per kilogram dose I don't think they really guided yet how many but I think by the end of the year. We should we should have a good number of patients on that expanded cohort as well as the completion of the phase one.

We think the best way to update people on the.

Profile you know the emerging profile is at a at appropriate medical conferences. So that's why we've guided towards the.

Fourth quarter of this year presenting that updated data.

Dr. Briggs Morrison: Okay, thanks. Thank you, and our next question comes from David Leibowitz with Morgan Stanley. Your line is now open.

Okay. Thanks for.

Thank you enter next question comes with David Liebowitz with Morgan Stanley. Your line is now open.

David Leibowitz: Thank you very much for taking my question. When you look at the Menin Program, I guess, what do you see as the step after Phase II expansion? Once you select a dose in Phase I, you move to the Phase II portion. What do you see as the theoretical step beyond that point?

Thank you very much for taking my question. When you look at the men and program I'm I guess.

What what do you see as has the step after.

Phase two expansion once you select dose in phase one.

Moved to the phase two portion what do you see is the theoretical step beyond that point.

Dr. Briggs Morrison: Yeah, thanks a lot, David. In, we think one potential avenue is a single-arm registration approach. So if you look at some of the other agents that have targeted agents for acute leukemias, they've been able to register the drug.

Yeah, Thanks, a lot David so.

And we did one potential Avenue is a.

Single arm registration approach. So if you look at some of the other agents that have targeted agents for acute leukemias, they've been able to register the drug.

Dr. Briggs Morrison: based upon a single-arm trial looking at complete response rates and durability of those responses. So that is an avenue that we think, depending on, you know, how active the drug is, that could be potential.

Based upon a single arm trial looking at complete response rates and durability of those response. So that is an avenue that we think depending on.

How active the drug is.

That could be a potential.

Dr. Briggs Morrison: Obviously, you know, the the next step would be to think about how we can combine this agent with standard of care for patients with AML. And so we're giving some thoughts to that, both in the MLR population, combining it either with induction chemotherapy or as maintenance after transplant. There's a variety of different designs we've thought about. And in the NPM1 space, remember that NPM1, there's about 15% of patients who have just an NPM1 mutation with no other co-mutation. But the majority do have other commutations, some of which, There are agents for, like split-3 inhibitors, so you could think about combinations with a split-3 inhibitor or an IDH inhibitor, or again, you know, integrating it into standard chemotherapy for the other, So I think there's a number of avenues, but the one that we're hopeful for is that we could actually get the drug registered on a single arm trial, should the response rate be of sufficient magnitude to allow that.

Obviously, you know the next step would be to think about how we can combine this.

Agent with standard of care.

For patients with A.M.L.

And so were given some thought.

To that both in the MLL R population, combining it either with induction chemotherapy or as maintenance after transplant, there's a variety of different.

Designs, we've thought about and in the NPL one space you remember that NPM. One there is about 15% of patients who have just been NPM one mutation with no other cold mutation.

But the majority do have other commutation some of which.

There are agents for like the three inhibitor. So you could think about combinations with a three inhibitor already or an IDH inhibitor core again.

Integrating it into standard chemotherapy for the other patients.

So I think there's a number of avenues, but.

But the most the one that we would.

Oh, we're hopeful for is that we could actually get the drug registered on a single arm trial.

Should their response rate be a sufficient magnitude to to allow that.

Dr. Briggs Morrison: Thank you for that. And what would you, I guess, need to learn from the dose escalation portion before you proceed with moving in the pediatric direction?

Thank you for that and.

What would you I guess need to learn from the dose escalation portion before you proceed with moving on the pediatric direction.

Dr. Briggs Morrison: Actually, not that much. So we're working with the pediatric groups now. As I said, the MLLR, ALLN kids, and AMLN kids are areas of high unmet need. So, you know, I think if we can even get a little bit of PK data from the adults, that may be enough. And that's where we're going to start the pediatric program, but we'll say more about that in a future

I'm actually not that much so we're working with it with a pediatric groups now.

Yes, the as I said, the MLL R JLL and kids and am allocated our air at high unmet need. So I think if we can even get a little bit of PK data from the adults that that may be enough to start the pediatric program, but we'll have we'll say more about that and in a future call.

David Leibowitz: Thanks for taking my question. Thank you. Our next question comes from Joel Beatty with Citi. Your line is now open. Hi, thanks for taking the questions. The first one is on the Augment 101 trial. Can you give a rough sense of how many cohorts of data we might see if the data presentation ends up being in Q4?

Thanks for taking my questions.

Thank you weren't next question comes from Joel Beatty with Citi. Your line is now open.

Hi, Thanks for taking my questions. The first one is on a augment what a one trial could you give a rough sense of how many cohorts of data that you might see if data presentation ends up being in Q4.

Joel Lawrence Beatty: Yeah, so I think Joel, you know, the reason we sort of guided to Q4 is that we're hopeful that we could have finished the phase one portion of the trial and know what the MTD is and know what the recommended phase two dose is. However, how many cohorts it takes to do that is not entirely clear. If you look at the literature in these dose escalation trials, it's somewhere around four or five cohorts to get to your recommended phase two dose. But I think part of the reason we tried to guide it to the end of the year is that we think the phase one, we would hope that the phase one portion would be done, and that we would have a recommended phase two dose. The phase two cohorts may actually have already opened by the end of the year, but that's to be determined.

Yeah. So I think Joe you know the the reason we sort of guided to Q4 is.

We're hopeful that we could have finished the phase one portion of the trial and know what the MTD is and know what the recommended phase two dose.

How many cohorts it takes to do that is is not entirely clear. If you look at the literature and these dose escalation trials its somewhere around four or five cohorts to get to your recommended phase two dose, but yeah. I think part of the reason we tried to guide to the end years, we think the phase one we would hope that the phase one portion will be done.

And that we would we would have a recommended phase two dose is phase two cohorts may have actually already opened by the end of the year, but that said that to be determined.

Dr. Briggs Morrison: And then one other question on the CSS1R. On the graph that shows the program with the CSF-1R, obviously, it shows really impressive responses, you know, even though it's just a small data set so far, can you help give context of what gives you confidence that these responses you're seeing are due to the drug as opposed to other therapies that the patient may be on?

Great. Thanks for that one other question on those thoughts one our <unk> from an undergrad first of all of you have program, but the feel stuff when our <unk>, obviously give us some looks really impressive responses you know even though it's just small data. So far can you help give context of you know what gives you confidence that moves.

As far as what's you're seeing or do it a drug as opposed to other therapies that are patient maybe on.

Dr. Briggs Morrison: Yeah, thanks for the question. The way the trial is designed is that the patients have to be stable on their current, as you know, there are a number of different agents that people use, whether it's steroids, calcineurin inhibitors, ibrutinib, ruxana, etc. So whatever agent they're on, they have to be on that stable regimen for a period of time so that we can actually evaluate what our drug does. Once they are treated with our drug, if they have a response, then the investigators are allowed to start tapering off the other drugs that they're on, but there's a requirement that there be no change to their existing therapy when we put them on our test.

Yeah. Thanks for the question. So you know the way that the trial is designed is the patients have to be stable on their current.

As you know there a number of different agents that people use whether steroids counts and earn inhibitors I broke new rux et cetera, So whatever agent there on they have to be on that stable regimen for a period of time and and so that we can actually evaluate what our drug does.

Once they are treated with our drug if they have a response.

Then the investigators are allowed to start tapering off the other drugs, Iran, but there's there's a requirement that there'd be no change to their existing therapy.

Joel Lawrence Beatty: Great, thank you. Thank you, and as a reminder, to ask a question, you will need to press star then 1 on your touchtone telephone. To withdraw your question, press the pound key.

When we when we put them on our test there.

Great. Thank you.

Thank you and as a reminder to ask a question you will need to press Star then one on your touched on telephone to withdraw your question press the pound key.

Christopher Mirai: Our next question comes from Christopher Mirai with Nomura Instanet. Your line is now open. Hello, this is Jackson Harvey on behalf of Christopher Mirai. My first question is on Augment 101. Given that it's an unselected patient population, can you give us some early insight into the distribution of mutation types that are currently enrolled or what you expect to enroll?

Your next question comes from Christopher MRI with Nomura Instinet. Your line is now open.

Hello. This is Jackson Harvey on for Christopher MRI, My first questions on augment one on one.

Given that it's an unselected patient population can you give us some early insight into the distribution of patient types that are.

Currently enrolled or what you expect to enrol and then.

Dr. Briggs Morrison: And then for the PD measurements, how should we expect PD to be reported in patients that do not have the relevant mutations? Thank you.

For the key theme measurements, how should we expect P. D to be reported in patients that do not have the relevant mutations. Thank you.

Dr. Briggs Morrison: Yeah, hi Jackson, thanks so much for the question. So, as I said, they're not required to have either MLLR or NPM1 to go into the Phase I portion. Having said that, the investigators who are participating know how the drug works, are clearly aware of all the preclinical data, and we've gotten certainly feedback from them that they're biased towards putting patients who have one of those two known genetic abnormalities. So, we can't say for certain where that's going to end up, but we, you know, I think we're optimistic that the patient population will be enriched for patients who have Can't tell you exactly how enriching it will be, but I think it'll be.

Yeah, Hi, Jackson, Thanks, so much where the question. So as I said that they're not required to have either MLL R or NPM wanting to go into the phase one portion.

Having said that the investigators who are participating.

No how the drug works are acutely aware of all the preclinical data and our and you know we've gotten certainly feedback from the their bias towards putting on patients who have one of those two known genetic abnormalities. So we can't say for certain where that's going to end up but we.

I think we're optimistic that this patient population will be enriched for patients who have one of the two known genetic Legion can't tell exactly how enriched but I think it'll be in rich.

Christopher Mirai: The question about pharmacodynamics is one that our team continues to work on. Your question was, how do you assess pharmacodynamics in patients who don't have the mutation? We're, to be honest, still working hard on pharmacodynamics in patients who do have the mutation. So I think that's why I highlighted in my comment more about PK. I think we have a really good understanding of that.

The question for Pharmacodynamics is one that our team continues to work on your question was how you assess pharmacodynamics in patients who don't have the mutation.

Were to be honest, we're still working hard on pharmacodynamics and patients who do have mutation. So.

I think that's why I highlighted in my comment more about PK I think we have a really good understanding of PK exposures, we need for efficacy. There are some assessments, we can do of.

Dr. Briggs Morrison: P.K. exposures we need for efficacy. There are some assessments that we can do that have to do with understanding how the transcriptional activation of certain genes by the MLL-Menin interaction, we can look at changes in Menin, we can look at changes in binding of Menin to the chromosome, but you know, you are correct, it is harder in patients without the mutation where we rely more on PK.

And having to do with understanding how the transcriptional activation certain genes by the MLL men and interaction. We can look at changes in men. We can look at changes in binding of men into the chroma from us on but you know it's you are correct. It is harder in patients without the mutation where are we.

Christopher Mirai: Got it. And if I can sneak in one more question on axotillumab...

Rely more on PK.

Got it and if I can sneak in one more question on X., killing Matt I'm, just curious about the or if you're seeing a differential response based on the organ system involved and whether these phase two expansions could be registrational. Thank you.

Christopher Mirai: I'm just curious about the, uh, if you're seeing a differential response.

Christopher Mirai: This is a response based on the organ system involved.

Dr. Briggs Morrison: and whether these Phase II expansions could be registered. Thank you.

Christopher Mirai: Yeah, I think it's too early to say whether, you know, we're seeing different responses. I think that the initial data we showed was five patients, only four of which were valuable. So it's a little hard to say that, you know, that's what I think the phase two portion is for, to try to characterize that. So I think it's just a little early to say.

Yes, it's too early to say, whether you know we're seeing different responses I think that the initial data. We show was five patients only four of which were a valuable. So it's a hard to say that you know that's what I think the phase two portion sports try to characterize that.

So I think it's still early to say.

Thank you and I'm showing no further questions in the queue at this time I'd like to turn the call back to Briggs Morrison for any closing remarks.

Dr. Briggs Morrison: Thank you, and I'm showing no further questions in the queue at this time. I'd like to turn the call back to Briggs Morrison for any closing remarks.

Dr. Briggs Morrison: Oh, thanks very much, Robert. Thanks, everybody, for joining us on the call. I guess today's a voting day in parts of the country. We just recommend that you wash your hands after you vote, and we look forward to keeping in touch.

Oh, thanks, very much operate thanks, everybody for joining us on the call.

I guess today's voting day in part of the country. We just recommended to wash our hands. After your vote and ER, we look forward to keeping in touch.

Ladies and gentlemen, this concludes today's conference call. Thank you for participating you may now disconnect.

Operator: Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect. Thank you for watching!

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Operator: BF-WATCH TV 2021