Q4 2020 Chimerix Inc Earnings Call
Good morning, ladies and gentlemen, and welcome to the kind of married fourth quarter and year end 2020 earnings conference call.
Operator: Good morning, ladies and gentlemen, and welcome to the Chimerix fourth quarter and year-end 2020 earnings conference call. I would now like to introduce you to your host for today's call, Michelle LaSpaluto, Vice President of Strategic Planning and Investor Relations at Chimerix. Please proceed.
Like to introduce you to your house for today's call Michelle lots of the Lutalo Vice President of strategic planning and Investor Relations, Inc. High Merit. Please proceed.
Thank you good morning, everyone and welcome to the tenure of fourth quarter and year end of 'twenty 'twenty financial and operating results Conference call. This morning, we issued two press releases on our fourth quarter operating update and the second one on the ongoing COVID-19 trial piece that you can access these press releases and our Investor section of.
Michelle LaSpaluto: Thank you. Good morning, everyone, and welcome to the Chimerix fourth quarter and year-end 2020 Financial and Operating Results Conference call. This morning, we issued two press releases on our fourth quarter operating update and a second one on the ongoing COVID-19 trial DSTAT. You can access these press releases in our investor section of the website.
The website with me on today's call are President and Chief Executive Officer, Mike Sherman, Chief Medical Officer, Alan Melamed, Chief Financial and business Officer, Mike Andriole, Chief Science officer of random linear and our newest member of the team Tim T M pronounced technical Technology Officer, Josh M.
Michelle LaSpaluto: With me on today's call are President and Chief Executive Officer, Mike Sherman, Chief Medical Officer, Allen Melemed, Chief Financial and Business Officer, Mike Andriole, Chief Science Officer, Randall Lanier, and our newest member of the team, Chief Infrared Technology Officer, Josh Allen. Before we begin, I would like to remind you that the statements made on today's call include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties and other factors. These risks and uncertainties and other factors could cause results to differ materially from those referred to in the forward-looking statement.
Before we begin I would like to remind you that the statements made on today's call include forward looking statements within the meaning of the private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties and other factors these risks and uncertainties and other factors could actually.
We've also could differ materially from those referred to on the forward looking statements. Please refer to our filings with the SEC for a more complete disclosure of these risks and uncertainties.
Michelle LaSpaluto: Please refer to our filings with the SEC for more complete disclosure of these risks and uncertainties. At this time, I would now like to return the call over to President and Chief Executive Officer, Mike. Thanks, Michelle.
This time I would like now I would like now on to return the call over the President and Chief Executive Officer, Mike Sherman.
Thanks, Michelle and good morning, everyone and thanks for joining us I'm pleased to provide some additional color behind today's press releases.
Michael A. Sherman: And good morning, everyone. Thanks for joining us. I'm pleased to provide some additional color behind today's press release. You'll note we've positioned ourselves to deliver on multiple value-driving milestones in 2021 across all of our programs. That's a credit, of course, to the way this team is executing in every functional area.
You'll note, we've positioned ourselves to deliver on multiple value driving milestones in 2021 across all of our programs.
That's a credit of course to the way. This team is executing in every functional area I'm happy to say that team is now even more capable as we've completed ahead of schedule and the integration of the Oct suite of staff in sort of like high merits organization structure.
Michael A. Sherman: I'm happy to say that our team is now even more capable, as we've completed, ahead of schedule, the integration of the Oncosteutics staff into the Chimerix organization structure. We've quickly pivoted from organizing ourselves to the process of accelerating the Oncosteutics pipeline, particularly Onc 201. Let me start my comments with the update we received in the last few days from the FDA on the extension of the PDUFA date to July. The extension is intended to allow the FDA additional time to review new dose modeling we provided related to infants, newborns up to three months of age. The results of that modeling, which we've already submitted, supported the same weight-based suspension formulation dosing regimen we had already recommended for older pediatric patients.
We've quickly pivoted from organizing ourselves to the process of accelerating the orca suite ex pipeline, particularly on two of one.
Let me start my comments with the update we received in the last few days from the FDA on the extension of the to do the date to July.
The extension is intended to allow F. D. A additional time to review of new dose modeling, we provided related to infants newborns up to three months of age.
The results of that modeling that we've already submitted.
Reported the same weight based suspension formulation dosing regimen, we had already recommended for older pediatric patients.
Michael A. Sherman: The fact that the FDA asked for this additional information highlights a key aspect of our program that satisfies an important unmet need, a formulation easily administered in a broad pediatric setting. We continue to feel very good about the NDA review process and look forward to the final step. We confirmed with BARDA that their process remains on track and will not be impacted by the review timing. We still expect to see an RFP next month.
The fact that the FDA asked for this additional information highlights of key aspect of our program that satisfies unimportant unmet need of formulation easily administered in a broad pediatric setting we.
We continue to feel very good about the M. D. A review process and look forward to the final steps.
We confirmed with BARDA of their process remains on track and will not be impacted by the review timing.
We still expect to see an RFP next month.
The fact that we hadn't planned on shipping product into the stockpile until the second half of the year anyway means there's no financial impact of the updated review timing, we're still in a position to ship up to $100 million of product into the stockpile in the second half of this year.
Michael A. Sherman: The fact that we hadn't planned on shipping product into the stockpile until the second half of the year anyway means there's no financial impact to the updated review timing. We're still in a position to ship up to $100 million of product into the stockpile in the second half of this year. Let me move now to our DSTAT program for acute lung injury in patients with COVID-19. I have to say I was not expecting to see such a differentiation in outcomes between the 0.25 milligram dose of DSTAT and the control arm in this trial.
Let me move now to our D Stat program for acute lung injury in patients with COVID-19.
I have to say I was not expecting to see such of differentiation in outcomes between the 0.25 milligram dose of the stat and the control arm in this trial.
Michael A. Sherman: The fact that all six DSTAT patients achieved the targeted two-point NIAID ordinal scale improvement and only two placebo control arm patients did not. The fact that there were two deaths on the control arm and none on D-STAT.
The fact that all six D stat patients achieved the target of two point NIAD ordinal scale improvement and only two placebo control arm patients did.
The fact that there were two deaths on the control arm and non on D stat.
Michael A. Sherman: The fact that these clinical results were supported by biomarker analysis relevant to D-STAT's mechanisms of action, and the fact that there were no treatment discontinuations due to adverse events on D-STAT compared to two on placebo, all of those things are very important. Of course, this is a small cohort, and we know there were demographic imbalances which favored the DSTEDD arms, so we take a dose of caution with that option. That having been said, I've seen a lot of excitement from other trials based on single-arm data. In our case, I'm glad we stuck to the discipline of randomization and blinding.
The fact that these clinical results were supported by biomarker analysis relevant to the stats the mechanisms of action and the fact that there were no treatment discontinuation due to adverse events on the stack compared to two on placebo all of those things are very promising.
Of course this is the small cohort and we know there were demographic imbalances, which favorite of the D. Stat arms. So we take a dose of caution with that optimism.
That having been said I've seen a lot of excitement from other trials based on single arm data in our case I'm glad we stuck to the discipline of randomization and blinding all of.
Michael A. Sherman: I'll let Allen go into more detail on these findings, but it's also important to note we've completed enrollment of the second cohort, so we'll be able to supplement this data with another analysis next quarter. Recall that positive signals here are not just promising signals in the context of COVID but also relevant to acute lung injury or acute respiratory disease syndrome from other causes. There may indeed be a longer-term need to treat a COVID population, particularly if we continue to see mutant variants of the virus.
Let Alan go into more detail on these findings, but it's also important to note. We've completed enrollment of the second cohort. So we'll be able to supplement this data with another analysis next quarter.
Recall that positive signals here are not just promising signals in the context of COVID-19, but also relevant to acute lung injury or acute respiratory distress syndrome from other causes.
There may indeed be of longer term need to treat the COVID-19 population, particularly if we continue to see mutant variants of the virus.
Michael A. Sherman: But even if COVID infections decline dramatically, as we hope they do, we know these other indications are quite large opportunities. For the more advanced D-STAT program, the Phase 3 trial in frontline AML, we've recently opened the first clinical sites and are ready to begin screening patients. You'll hear us refer to that as the DASH AML trial.
But even if the COVID-19 infections decline dramatically as we hope they do we know these other indications are quite large opportunities.
For the more advanced the step program the phase III trial in frontline AML. We've recently opened the first clinical sites and are ready to begin screening patients you'll hear us refer to that as the dash a M L trial.
Michael A. Sherman: Recall that this multi-center, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of D-STAT in combination with standard intensive induction and consolidation chemotherapy for the treatment of newly diagnosed AML patients. Our trial design includes an early assessment of the first 80 randomized, evaluable patients. And in particular, we'll have a robust assessment of comparative complete response and MRD rates, minimal or measurable residual disease. A recent publication in the Journal of the American Medical Association detailed a meta-analysis of over 11,000 patients linking MRD negativity with disease-free survival and overall survival.
Recall this multi center randomized double blind placebo controlled study will evaluate the efficacy and safety of D. Stat in combination with standard intensive induction and consolidation chemotherapy for the treatment of newly diagnosed AML patients.
Our trial design includes an early assessment of the first 80 randomized evaluable patients and in particular will have a robust assessment of comparative complete response and M. R D rates minimal or measurable residual disease.
A recent publication in the journal of the American Medical Association detailed of meta analysis of over 11000 patients linking the M. R D negativity with disease free survival and overall survival.
Michael A. Sherman: As a result, this important data readout will give us a strong signal on the likelihood of success for the full Phase III trial. We expect that analysis to occur in 2022. Last but certainly not least, our newly combined teams are detailing our plans to advance ONC 201 toward registration. Recall, this is the program that caught our attention and drove our acquisition of Alka-Sutex.
As a result, this important data readout will give us a strong signal on the likelihood of success for the full phase III trial, we expect that analysis will occur in 2022.
Last and certainly not least our newly combined teams are detailing our plans to advance on two O one toward registration.
Recall this is the program that caught our attention and drove our acquisition of bulk of Sudan.
Michael A. Sherman: We were excited by several aspects of the program. It's targeting among the most challenging diseases in an already challenging field. For example, the H3K27M mutant form of glioma, which was recently classified by the WHO as a grade four glioma, regardless of histology.
We were excited by several aspects of the program.
It's targeting among the most challenging diseases in an already challenging field. The H three K twenty-seven of M mutant form of Glioma, which was recently classified by the W. Eight show as a a grade four glioma regardless of histology.
Michael A. Sherman: There are no good options for these patients today, and no drugs have been approved for them in the last 15 years. Onc 201 has already demonstrated compelling and particularly durable responses from single-agent treatment using the most challenging of metrics to define responses in glioma. It's RANO-HGG, which stands for response assessment in neuro-oncology high-grade glioma. Raynaud criteria have both imaging and clinical hurdles required for bona fide responses.
There are no good options for these patients a day and no drugs approved for them in the last 15 years.
Entre of one has already demonstrated compelling and particularly durable responses from single agent treatment using the most challenging of metrics to define responses in glioma as Rhino H G G, which stands for risk spots assessment in neuro oncology high grade glioma.
Raynaud criteria have both imaging and clinical hurdles required for bona fide responses. So it was indeed, a high hurdle for all two of one to clear in achieving these responses.
Michael A. Sherman: So it was indeed a high hurdle for all 201 to clear in achieving these responses. Furthermore, these tumor responses have been accompanied by meaningful clinical benefits, including performance status and neurological improvement. OG201 is also an easily delivered oral drug with a very attractive safety profile. Alkaceutics Management had previously completed robust dialogue with the FDA to agree on very detailed inclusion criteria to define the potential registration cohort of patients. Our research also supports the notion that there are low barriers to commercial success.
These tumor responses have been accompanied by meaningful clinical benefit including performance status and neurological improvement.
Also of one is also easily delivered oral drug with very attractive safety profile.
I'll go through the management of had previously completed robust dialogue with the F. D. A to agree on a very detailed inclusion criteria to define the potential registration cohort of patients.
Our research also supports the notion that there are low barriers to commercial success the.
Michael A. Sherman: The neuro-oncology field is already testing for this mutation and has a very high unaided awareness of the ONC 201 program. As the data matures for the last couple of patients treated, which we expect in the next few months, we will prepare to trigger a blinded independent central review to confirm response rate and duration of response. Recall much of the data from this 50 patient cohort has already been reviewed in a blinded fashion. We also had our own imaging expert review patient data as part of our diligence.
<unk> oncology field is already testing for this mutation and has a very high unaided awareness of the Alt two of one program.
As the data matures for the last couple of patients treated which we expect on the next few months, we will prepare the trigger a blinded independent Central review the confirmed response rate and duration of response.
Recall much of the data from this 50 patient cohort has already been reviewed in a blinded fashion.
We also had our own imaging expert review data Ah patient data as part of our diligence.
This new blinded assessment will be performed in the second half of this year using two readers with the third for adjudication as necessary, we do plan to announce those results.
Michael A. Sherman: This new blinded assessment will be performed in the second half of this year using two readers with a third for adjudication as necessary. We do plan to announce the results. It's also worth mentioning the other imiprodomes in the pipeline that are continuing to progress in development, OCT206 and OCT212. We're currently enrolling patients to be treated with OCT206 in an NIH-funded first-in-human dose escalation trial. I should note the first cohort has been completed without any dose-limiting toxicity, so we've moved on to the second cohort.
It's also worth mentioning the other nippert loans in the pipeline that are continuing to progress on development. All of two of six in all of 212 were currently enrolling patients to be treated with <unk> two of six under an NIH funded first in human dose escalation trial I should note. The first cohort has been completed without a dose limiting.
<unk> toxicity, so we've moved on to the second cohort.
In the meantime, we're continuing the preclinical work on all of 212 with support from Brown University.
Michael A. Sherman: In the meantime, we're continuing the preclinical work on OCTU-12 with support from Brown University. Now, let me hand the call over to Allen, Dr. Melemed, to give a little more color on the data from our first cohort in the COVID-19 trial. Mike, thank you, and good morning.
Let me hand, the call over now to Alan Dr. Melamed to give a little more color on the data from our first cohort in the COVID-19 trial.
Mike Thank you and good morning.
Earlier today, we released our press release on top line results from the first cohort of our phase two three study of hospitalized COVID-19 patients with ally.
Allen S. Melemed: Earlier today, we released a press release on the results from the first cohort of our Phase 2-3 study of hospitalized COVID-19 patients with ALI. This cohort randomized 12 patients one to one to receive four milligrams per kilogram bolus, a loading dose followed by a 0.25 milligram per kilogram per hour of DSTAT or a similar placebo. All patients received the appropriate standard of care that was determined according to each individual hospital practice
This cohort randomized 12 patients one to one to receive four milligrams per kilogram bolus.
Loading dose followed by a 0.25 milligram per kilogram per hour of dis debt or similar to placebo of infusion.
All patients received the appropriate the standard of care that was determined according to each individual hospital practices.
Allen S. Melemed: Although the standard of care for COVID-19 continually changed during the course of the trial, that standard of care allows for the following therapy, from Death Severe: Standard or Intermediate Intensity Anticoagulation Prophylaxis, prior convalescent plasma, and prior COVID-19 therapeutic antibody. The primary endpoint of the trial is survival without the need for mechanical ventilation through day 28, with a key secondary endpoint of at least a two-point change in the NIAID ordinal scale. It is worth noting that this NIAID ordinal scale improvement was our initial proposed primary endpoint, as it has been the basis for emergency use authorizations of other drugs. However, we prefer this end point as it provides a more continuous measure of the drug's
Although the standard of care of COVID-19 continually changed during the course of the trial.
The ending of care of lots of the following therapies from death severe dexamethasone standard or intermediate intensity anticoagulation prophylaxis prior convalescent plasma and prior COVID-19 therapeutic antibodies.
The Afirma endpoint of the trial is survival without the need from mechanical ventilation through day 28.
With the key secondary endpoint of at least a two point change in the night at ordinal scale.
It is worth noting that this NIAID ordinal scale improvement was our initial proposed primary endpoint.
As it has been the basis for emergency use authorizations have other drugs since.
We prefer the endpoint and to provide the more continuous measure of the drugs benefit.
While we're very encouraged by the preliminary data as we minimize bias with the placebo control trial, we still remain cautious not to draw too many conclusions to the the small sample size with that I'd like to share a few of the study results.
Allen S. Melemed: While we are very encouraged by this preliminary data as we minimize bias with the placebo-controlled trial, we still remain cautious not to draw too many conclusions due to the small sample size. With that in mind, I'd like to share a few of the study results. All six D-STAT patients. Unknown Executive, Soumit Roy, Michelle LaSpaluto, Naureen Quibria, Will OConnor, Kevin Strang. One patient at DSTAT received mechanical ventilation and subsequently recovered. Two patients on placebo required mechanical ventilation. One patient died on day two, and a second patient died after the 28-day follow-up. No patients are known to have died in the study, but there are some notable imbalances based on characteristics.
All six the staff patients achieved at least a two point ordinal scale improvement and two of six placebo patients showed at least the two point improvement.
One patient on these type of UC and mechanical vertical like ventilation and subsequent recovery.
Two patients on placebo required mechanical ventilation one patient died on day, two and a second patient guide after the 28 day follow on.
No patients are known to have died on defense.
There are some notable imbalances of based on characteristics more patients on placebo presented on HIFU oxygen and other were older than average on the patient that received these pad.
Allen S. Melemed: More patients on placebo presented on high-flow oxygen, and others were older and average in the patient and received decent treatment. We also performed an evaluation of multiple biomarkers, including IL-6, MCP-1, and D-dimer. Increases in these biomarkers have been associated with excessive inflammatory inflammation and coagulation disorders in severe COVID-19 and have been correlated with increased risk of death.
We also performed in the valuation of the multiple biomarkers, including the IL six MCP want and D dimer.
Increases in these biomarkers had been associated with excess of inflammatory inflammation and correlation of disorders and severe COVID-19, and have been correlated with increased risk of debt.
Allen S. Melemed: Treatment with D-STAT may reduce the concentration of these biomarkers and, more importantly, the pathologic pathways they represent by inhibiting HMGV-1, platelet-affected 4, and P2-Lex. We did not observe an elevation of these biomarkers in any patient who received, However, we did observe an increase in these biomarkers in two of the patients who received placebo, and, in fact, each of these patients experienced complications, including a pulmonary embolism in one patient and acute respiratory distress in another.
Treatment with <unk> may reduce the concentration of these biomarkers and more importantly, the path logic pathways. They represent by inhibiting H M. G. P. One play of the fact that foreign piece of electric.
We did not observe the elevation of these biomarkers in any patient who received the stat. We.
We did observe an increase of these biomarkers in two of the patients who received placebo and <unk>.
Each of these patients experience experienced complications including of pulmonary embolism in one patient and acute respiratory distress and another.
Allen S. Melemed: This favorable separation across multiple endpoints, accompanied by supporting buy market trends, is quite promising, and we're eager to determine if these results are sustained or improved in the second cohort. We have completed enrollment in the second cohort, which evaluates the same D-STAT bolus dose followed by a higher dose of D-STAT of 0.325 milligrams per kilogram per hour. An external data and safety monitoring board will evaluate the safety of Cohort 2 and recommend whether it's safe to enroll an additional 50 patients in Cohort 3 and what those treatments will be. We expect to have the data from this quarter to next quarter.
This favorable separation across from multiple endpoints of accompanying by supporting biomarker trends is quite promising and were eager to determine if the results are sustained or improved in the second cohort.
We have completed enrollment of the second cohort, which are value with the same piece that bolus dose followed by a higher dose of these debt of 0.2 of two five milligrams per kilogram per hour.
The external data and safety monitoring board will evaluate the safety of cohort two and recommend whether it's safe to enroll an additional 30 of patients in cohort three and what goes to administer.
We expect of the data from cohort two next quarter.
With that I'll now turn the call over to Mike for a financial review.
Allen S. Melemed: With that, I'll now turn the call over to Mike for a financial review. Thanks, Allen, and good morning, everyone. As Michelle mentioned in her introductory remarks earlier today, we issued a press release containing our financial results for the fourth quarter and full year 2020. Starting with our balance sheet, at the end of December 2020, we had approximately $79 million in capital to fund operations. Of course, we had two meaningful events which occurred after year-end during the month of January.
Thanks, Alan and good morning, everyone as Michelle mentioned in her introductory remarks, the owners today, we issued a press release containing our financial results from the fourth quarter and full year of 2020.
Starting with our balance sheet at the end of December 2020, we had approximately $79 million of capital to fund operations of course, we've got two meaningful events, which occurred after year end during the month of January.
The first was the acquisition of the market students, which included $39 million in cash consideration of which $25 million was paid immediately and 14 million of deferred after one year of closing the.
Allen S. Melemed: The first event was the acquisition of Oncosutics, which included $39 million in cash consideration, of which $25 million was paid immediately, and $14 million is deferred up to one year from closing. The second event was the public stock offering in January, which included the sale of 13.5 million shares for total proceeds, net of underwriting fees and expenses, of approximately $108 million.
The second event was the public stock offering in January which included the sale of $13 5 million shares for total proceeds net of underwriting fees and expenses of approximately of $108 million.
Michael T. Andriole: After taking into consideration the cash associated with the acquisition of Aquasutics, the subsequent follow-on financing, and operating expenses for January, our cash balances on January 31, 2021 were approximately $160 million. Turning to our Statement of Operations, the company reported a net loss of $11.7 million, or $0.19 per basic and diluted share, for the fourth quarter of 2020, compared with a net loss of $3.5 million, or $0.06 per basic and diluted share, for the fourth quarter of 2019.
After taking into consideration of the cash associated with the acquisition of arc of students. The subsequent follow on financing and operating expenses for January our cash balances on January 31, 2021 were approximately $160 million.
Turning to our statement of operations. The company reported a net loss of $11 7 million or 19 cents per basic and diluted share for the fourth quarter of 2020 compared with the net loss of three and a half million of six cents per basic and diluted share on the fourth quarter of 2019.
Revenues for the fourth quarter of 2020 decreased of $1 1 million compared to $6 8 million from the same period of 2019 in 2019 debt figure included a $5 million upfront payment from the out license of Brincidofovir to some bio of four indications other than the treatment of work from Fox viruses.
Michael T. Andriole: Revenues for the fourth quarter of 2020 decreased to $1.1 million compared to $6.8 million for the same period in 2019. In 2019, that figure included a $5 million upfront payment from the out license of Brinstead Ophivir to Symbio for indications other than the treatment of the orthopox virus. Research and development expenses increased to $8.7 million for the fourth quarter of 2020, compared with $7.5 million for the same period in 2019. General and administrative expenses also increased to $4.2 million for the fourth quarter of 2020, compared to $3.1 million for the same period in 2019. Loss from operations was $11.8 million for the fourth quarter of 2020, compared to a loss from operations of $3.9 million for the same period in 2019.
The research and development expenses increased to $8 $7 million of the fourth quarter of 220, compared with $7 5 million from same period in 2019 General and administrative expenses also increased of $4 2 million from the fourth quarter of 2020 compared to $3 1 billion from the same period of 2019.
The loss from operations was $11 8 million from the fourth quarter of 220 compared to a loss from operations of $3 9 million from this.
Same period of 2019.
Turning to our forward looking financial projections 'twenty 'twenty, one is expected to be a pivotal year for the company in many ways and certainly from a financial perspective, because we may achieve our first regulatory approval. The first commercial product sale of Brincidofovir to the U S strategic national stockpile.
To that end subject to FDA approval of Brincidofovir. Our recent interactions with borrowings of served to reinforce our previous guidance to have the procurement contract in place around the time of approval for Brincidofovir and we will be in a position to ship drug to the strategic national stockpile. Shortly thereafter.
In that scenario, we expect to have sufficient drug product manufacturer to supply up to $100 million of brincidofovir to the strategic national stockpile in 2021.
Michael T. Andriole: Turning to our forward-looking financial projections, 2021 is expected to be a pivotal year for the company in many ways, and certainly from a financial perspective, as we may achieve our first regulatory approval and first commercial product sale of Bristol Daphnevir to the U.S. Strategic National Stockpile. To that end, subject to FDA approval of brincidofavir, our recent interactions with BARDA have served to reinforce our previous guidance to have a procurement contract in place around the time of approval for brincidofavir, and we will be in a position to ship the drug to the Strategic National Stockpile shortly thereafter.
Therefore, there is potential to have meaningful revenue for Brincidofovir. This year. While we're also investing in three late phase programs anchored box of calling phase two data on areas of part of that Nate recurrent inch grew to 27 of them clean them up the acute lung injury in COVID-19 patients in the newly diagnosed acute myeloid leukemia. The exact amount of our R&D investments this year will depend on factors such.
The clinical trial enrollment timelines as well as clinical outcomes from data Readouts this year.
Our guidance for cash operating expenses for 2021, excluding any one time milestones receive or pay during the year is approximately $75 million, we will refine the street or in the coming months as data on key assumptions comes into focus.
Of course of these experiences have the potential to be completely offset or even exceeded by cash inflows associated with the sale of brincidofovir to the strategic national stockpile with that overview I'll turn the call back over to Mike for closing remarks.
Michael T. Andriole: In that scenario, we expect to have sufficient drug product manufactured to supply up to $100 million of brine sedatavir to the strategic national stockpile in 2021. Therefore, there's potential to have meaningful revenue from Brin's Adafobeer this year, while we're also investing in three late phase programs anchored by compelling phase two data in areas of high unmet need. Recurring H3K27 on mutant gliomas, acute lung injury in COVID-19 patients, and newly diagnosed acute myeloid leukemia
Thanks, Mike we enter 2021 in a strong position both financially and operationally to achieve the number of value, creating milestones. The Brincidofovir NDA review will set the stage for the beginning of stockpiling of that drug in the second half of this year, which will further strengthen our balance sheet. We expect to report the results of the blood.
It assessment of the registration cohort of on two of one in eight three K 27 of the mutant Gliomas and if positive. This would set the stage for a pre NDA meeting with the FDA the.
The modest investment we've made in the Covid trial of D. Stat is now yielding data with the next update in Q2, covering the second cohort will also monitor closely our enrollment of the phase III Dash AML trial of the stat as the year progresses with an eye toward the first 80 patient analysis, we expect to occur.
Michael T. Andriole: The exact amount of our R&D investments this year will depend on factors such as clinical trial enrollment timelines, as well as clinical outcomes from data readouts this year. Our guidance for cash operating expenses for 2021, excluding any one-time milestones received or paid during the year, is approximately $75 million. We will refine this figure in the coming months as data on key assumptions comes into focus. Of course, these expenses have the potential to be completely offset or even exceeded by cash inflows associated with the sale of Brent Adafobeer to the Strategic National Stockpile.
The next year.
This indeed is an exciting year for the company.
With that operator, we'll open it up for questions.
Thank you if you would like to ask a question you will need to press star one on your telephone to withdraw your question press the pound or hash key please standby, while we compile the Q&A roster.
Your first question comes from the line of Anne White.
H C Wainwright.
Good morning, everyone and congratulations on the date of this morning.
Michael A. Sherman: With that overview, I'll turn the call back over to Mike for his closing remarks. Thanks, Mike. We entered 2021 in a strong position, both financially and operationally, to achieve a number of value-creating milestones. The Brincid-Ofavir NDA review will set the stage for the beginning of stockpiles of that drug in the second half of this year, which will further strengthen our balance sheet. We expect to report the results of the blinded assessment of the registration cohort of ALK201 in H3K27M mutant gliomas.
So maybe just asking about.
On the COVID-19.
Study.
M.
While the state it is is excellent.
Previously discussed out of phase III trial could have 450 patients with ALS.
Ally.
<unk>.
And looking at the current COVID-19 environment changing due to the vaccines and potential competition.
The space how are you thinking about the commercial potential in the space and how are you thinking about.
Other studies in a R. D. S. Just wanted to get your thoughts on you know.
The potential.
Michael A. Sherman: If positive, this would set the stage for a pre-NDA meeting with the FDA. The modest investment we've made in the COVID trial of D-STAT is now yielding data, with the next update in Q2 covering the second cohort. We'll also monitor closely our enrollment in the Phase 3-AML trial of D-STAT as the year progresses with an eye toward the first 80 patient analysis we expect to occur next year. This is indeed an exciting year for the company.
For investment in the floor in a study of that large can you get a good return on it.
Yeah I know it's.
The right analysis, and that's exactly the kind of.
The way we were thinking about this from the beginning we had identified this says as much of an opportunity to evaluate.
The anti inflammatory.
The activity of of D stat.
And in an acute lung injury is as it was say a potential treatment for.
Michael A. Sherman: With that, Operator, we'll open it up for questions. Thank you. If you would like to ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound or hash key.
For Covid. So the way we will look at this is it's all the factors you just identified if indeed the infection rate is dropping dramatically.
Indeed.
And these these new variance could change that hopefully the adult but but.
Edward Patrick White: Please stand by while we compile the Q&A roster. Your first question comes from a line from Ed White with H.C. Wainwright. Good morning, everyone, and congratulations on the data this morning. So, maybe I'm just asking about... COVID-19. While this data is excellent, you've previously discussed that a phase three trial could have 450 patients with ALI. And, you know, looking at the current COVID-19 environment, changing due to the vaccines and potential competition in this space, how are you thinking about the commercial potential in this space?
If the the prospect for enrolling that trial is lower if.
There seem to have the accumulated as of as there have been a few drugs that are demonstrating benefit in this population.
Now to be clear this drug the stat could be combined with those that says it's been combined with the number of other therapies in the in this current trials. So there's still that opportunity, but we will assess the competitive landscape as well so I think realistically the the the real commercial opportunity of long term is.
And these are acute lung injury or acute respiratory distress syndrome of other causes and so what we'll be doing before we would pull the trigger on the phase III trial is to say does that make sense or does it makes sense based on the data of both clinical outcomes and biomarker data to pivot to.
Edward Patrick White: And how are you thinking about, you know, other studies in ARDS? Just wanted to get your thoughts on the potential for investment in a study that large. Can you get a good return?
Michael A. Sherman: Yeah, no, it's the right analysis, Ed, and it's exactly the way we were thinking about this. From the beginning, we had identified this as much an opportunity to evaluate anti-inflammatory drugs. Dr. Michael Beatty, Edward White, Maurice Raycroft, Joseph John, Michael Andriole, Maureen Quibria, if the prospect for enrolling in that trial is lower, if there seem to have accumulated as there have been a few drugs that are demonstrating benefit in this population.
On the alternative form of the of the disease now I should also add debt. The 450 patient trial was sized at really a placeholder I would say at a time, where we had no data on the on the the drug and so of course, our first step would be.
On the assessment of what we think the likely outcome of such of Phase III trial would be and resize. It accordingly based on the benefit that's been observed so it's possible that that debt that trial could be much smaller, but you've identified all of the right things in terms of how we're going to look at that going forward, we would only trigger that investment.
Michael A. Sherman: To be clear, this drug, D-STAT, could be combined with them as it's been combined with a number of other therapies in this current trial, so there's still that opportunity, but we will assess the competitive landscape as well.
Michael A. Sherman: So I think realistically, the real commercial opportunity long-term is in these acute lung injury or acute respiratory distress syndrome of other causes. And so what we'll be doing before we pull the trigger on a phase three trial is to say, does that make sense, or does it make sense, based on the data of both clinical outcomes and biomarker data, to pivot to an alternative form of the disease. Now I should also add that the 450 patient trial was sized, really a placeholder, I would say, at a time when we had no data on the drug.
Of both of you know, we're investing not only the money, but but the our people resources. When we've got some other very exciting programs that are nearing on.
On the NDA potential process that we want to make sure we get the appropriate attention too.
And Mike This is Alan if it's it might be worthwhile just to continue to add though that as we are seeing more resistant strains out there both resistant to the vaccine as well as some of the treatments. It is still.
Very important to have other treatment options in case patients to present with this disease.
Great. Thank you and.
Michael A. Sherman: And so, of course, a first step would be an assessment of what we think the likely outcome of such a phase 3 trial would be and resize it accordingly based on the benefit that's been observed. So it's possible that that trial could be much smaller.
Maybe just the question on <unk> and a M. L. I'm glad to hear the sites are now opening how should we be thinking about the enrollment of the 570 patients that you're targeting.
In the U S versus outside the U S.
Michael A. Sherman: But you've identified all the right things in terms of how we're going to look at that going forward. We would only trigger that investment of both, you know; we're investing not only money but our human resources when we've got some other very exciting programs that are nearing an NDA potential process that we want to make sure we give the appropriate attention to. And Mike, this is Allen.
When can we expect to see the first patient dosed.
And once the enrollment starts up.
And you can you give more or are you planning on giving more narrow guidance on the timing to the interim analysis.
Yeah. So we will on maybe I'll start with your last question first and that.
We'll give more guidance on the timing really of I'm isn't focused on debt 80 patient analysis of anything because we look at this really has two stages. The first on the.
Allen S. Melemed: It might be worthwhile just to continue to add, though, that as we are seeing more resistant strains out there, both resistant to the vaccine, as well as some of the treatments, it is still very important to have other treatment options in case patients do present with this disease. Great, thank you. Maybe just a question on D-STAT and AML. I'm glad to hear the sites are now opening.
Stage would be conducted in North America.
And once we see a positive signal I think we're well positioned to quickly expanded into Europe and other geographies.
But as that trial enrolled and we it's really seen the pace of the first dozen or so sites active activating that'll give us a better sense of how quickly that will enroll and what time next year, we would expect that 80 patient analysis to readout.
Michael A. Sherman: How should we be thinking about the enrollment of the 570 patients that you're targeting, you know, in the U.S. versus outside the U.S.? When can we expect to see the first patient dosed? And once enrollment starts up, can you give more or are you planning on giving more narrow guidance on the timing of the interim analysis? Yeah, so we will, maybe I'll start with your last question first, in that we'll give more guidance on the timing. Really, I'm as focused on that 80 patient analysis as anything because we look at this really as two stages. The first stage would be conducted in North America.
Remember that since we're looking at at the C. R and M. D. Those are early readout. So so really the gating item is getting those patients enrolled in the that's within a few months of bad debt. We would we would be able to report out on those early endpoints.
Yeah.
Great. Thanks, Mike.
And then you know I always ask about the Dod.
Brincidofovir and the BARDA contracts I'm just wondering.
Michael A. Sherman: And once we see a positive signal, I think we'll be in a position to quickly expand it into Europe and other geographies. But as that trial enrolls, and we really see the pace of the first dozen or so sites activating, that'll give us a better sense of how quickly that will enroll and what time next year we would expect that 80 patient analysis to read out. Remember that since we're looking at CR and MRD, those are early readouts.
With the change in the administration.
Are you expecting to see.
Any changes for the demands of <unk>.
Having the second treatment for smallpox.
In the stockpile and also how should we be thinking about.
The rest of the World I know, it's not a target of at first as you can only manufacture of 100 million dollars' worth of.
Michael A. Sherman: So really, the gating item is getting those patients enrolled, and it's within a few months of that that we would be able to report out on those early endpoints. Thanks, Mike. And then, you know, I always ask about, I'm just wondering, with the change in the administration, are you expecting to see any changes in the demand for having the second treatment for smallpox in the stockpile? And also, how should we be thinking about, you know, the rest of the world? I know it's not a target at first, as you can only manufacture $100 million worth.
This year, but how should we be thinking about increased capacity and perhaps sales outside the U S.
I'll answer the first question and then I'll, let Mike Andriole speaks of the opportunity outside the U S and I see no.
The change in the commitment to to support this program on the part of BARDA. In fact this this F D a.
The kind of update on the on the timeline Davis of fresh opportunity to to confirm that and they are very much on track and and really probably as as motivated as I've seen throughout the process.
Michael A. Sherman: But how should we be thinking about increased capacity and perhaps sales outside the U.S.? I'll answer the first question and then I'll let Mike Andriole speak to the opportunity outside the U.S. In fact, this FDA update on the timeline gave us a fresh opportunity to confirm that, and they are very much on track and, really, probably as motivated as I've seen throughout the process to continue with the plan that they identified from the beginning.
M. Two to continue with the plan that they've identified from from the beginning.
And so Uh huh.
The continued to feel very good and maybe even better than I did a few weeks ago, just because we've had this fresh opportunity to.
To get an update on the process all of them.
Maybe Mike if you want to speak to the U S opportunity.
Yeah.
The two Mike Hi, Ed from historically.
Oh, the phone stockpiling has been marginally of U S. A phenomenon on it as you know there's been some.
Michael A. Sherman: And so I continue to feel very good and maybe even better than I did a few weeks ago just because we've had this fresh opportunity to get an update on the process. Maybe Mike, if you want to speak to the OUF opportunity. Yeah, happy to do so. Hi, Ed.
The sales outside of the U S where certain products, but.
But relatively small on the Grand scheme of things.
We've seen more recently sales in Canada in Scandinavia, and other markets from from others in the space that.
Michael T. Andriole: Historically, biodefense stockpiling has been largely a US phenomenon. As you know, there have been some sales outside of the US for certain products, but relatively small in the grand scheme of things. We've seen more recently sales in Canada and Scandinavia and other markets from others in the space that indicate that shift. I think, post COVID-19, the case for stockpiling, certainly the economic case and the case from a medical perspective is obvious.
Indicate that shifting I think post COVID-19, the case for stockpiling certainly of the economic case in the the.
The.
The case from a medical perspective is obvious.
You see changes in how Europe collectively is looking at it with <unk>.
Perhaps on the equivalent of BARDA being contemplated in Europe, right now and so as we look out in the months of in years ahead, I think post COVID-19, you could see shifts from international stockpiling.
Michael T. Andriole: We see changes in how Europe collectively is looking at it, with, you know, perhaps an equivalent of BARDA being contemplated in Europe right now. And so, as we look out in the months and years ahead, I think, post COVID-19, you could see shifts in international stockpile that create a bigger opportunity outside of the US. You know, right now, obviously, we're focused on the US market, but we do see opportunity for the long term in other markets, including, obviously, Europe, but Asia as well.
The create a bigger opportunity.
Aside of the U S. Right now, we're obviously focused on the U S market.
We do see opportunity longer term.
And in other markets, including obviously Europe debt.
Asia as well.
Great. Thanks, Mike.
Your next question comes from the line of Summit ROI with Jones trading.
Michael T. Andriole: Great. Thanks, Mike. Your next question comes from the line of Soumit Roy with Jones Trading. Hi everyone, and congratulations on successfully completing a busy quarter.
Hi, everyone.
And congratulations on successfully.
Completing a busy quarter.
One first Cushing is M.
Soumit Roy: One first question is, Could you remind us where you are on the Oncocytic Program, Onc 201, and where you are in the FDA interaction post-acquisition? Do you have a meeting scheduled? Any, any response or anything on that side? Yeah, so we have not scheduled or requested a pre-NDA meeting yet. And to me, that's the, that's the pivotal discussions because we've had good discussions previously, and the Oncosteutics, legacy Oncosteutics team has gotten great clarity as to what those cohorts should look like and, and how the data should be analyzed.
Could you remind us where you are on the on capacity programs on two of one.
You are in the FDA interaction post acquisition do you have the meeting scheduled.
Any any response or anything.
On that side of.
Yeah. So.
We have a we have not scheduled or requested a a P.
Pre NDA meeting yet and to me that's the that's the the pivotal discussions because they've had good discussions.
Previously in the office, who the ex legacy Oxitec seamless.
<unk> gotten great clarity as to what the.
What that probe that cohort should look like and how the data should be analyzed so really we're in the mode now where are we.
Soumit Roy: So really, we're in the mode now where we're preparing to lock down databases and gather that data so that it may be subjected to that blinded, independent, central review. That would be the data then that we would prepare for a potential pre-NDA meeting. Of course, on the sidelines, there are the non-clinical CMC and non-clinical discussions that would happen independently, really just confirming the work that we believe needs to be included in the NDA.
We're preparing to.
Locke databases and gather that data so that it may be.
Subjected to that blinded independent Central review that would be the data then that we would.
The prepare for a potential of pre NDA meeting of.
Of course in the on the on the sidelines there are the the non clinical CMC and.
On the non clinical discussions that that would happen independently.
Just confirming the work that we believe needs to be included in the and the NDA, but.
Soumit Roy: But our focus is obviously gathering and accumulating that data for a potential pre-NDA meeting. I don't have a, I'm not ready to give a timeline for that, but we do expect to have that data from that blinded assessment here in the second half of this year.
But our focus is obviously gathering and the accumulating that data per potential pre NDA meeting I don't have the I'm not ready to give a timeline for that.
But we do expect to have that data from that blinded assessment here on the second half of this year.
I think so how comfortable you feel that if.
Michael A. Sherman: So how comfortable do you feel that FDA will go with response rate being a primary endpoint in this, and this result turns into registration enabling data? I think the feedback from the FDA, as evidenced by the minutes that we've reviewed, is definitive in terms of both the definition of patients that they want to see and the endpoints that they've defined as primary. Of course, beyond just the response rate, I think it will be as important for them to see the durability of responses in these patients, they'll see the safety profile, and they want to see the clinical benefits that are associated with those responses. One element of evidence, I think, that maybe correlates or validates the endpoint that the FDA has identified in this population is the way the cohort, the criteria for these patients, was defined. It was really defined.
If you will go with the response rate being the primary endpoint in this and this was all turns into a.
Registration, enabling data.
I think the the feedback from the FDA as evidenced by the minutes that we've reviewed is definitive.
In terms of both the the.
The the definition of patients that they want to see and the AR and the endpoints that they defined as as primary of course.
Beyond just the response rate I think it will be as important that they see the durability of responses in these patients they'll see the safety profile. They want to see the clinical benefits that are associated with those responses.
Michael A. Sherman: Not as much about the patients that are expected to benefit. It was mostly defined to define a patient population where responses could be reliably assessed. It's one of the reasons Reino criteria is used and was specifically identified by the FDA as the means to measure responses. And the trouble that was taken to exclude patients where those results or the ability to define responses would be challenged, either based on the location of the tumor or what have you, proximity to a prior therapy as another example, those all reinforce this plan that's quite straightforward and comprehensive in how you get to a reliable endpoint in these patients.
Those all reinforced this plan that that's quite the straightforward and comprehensive that how you got two of reliable and point in these patients. So that's a long answer to it [laughter] shorter answers, we're we're confident in and and how the F. D. A at the find this path and now it's a question of of just the preparing.
Michael A. Sherman: So that's the long answer to the shorter answer: we're confident in how the FDA is applying this path. And now it's a question of just preparing and accumulating the data. All right. Thank you. Thank you for the call.
Alright, and the data.
Alright, Thank you well thank you for the <unk> switching to the frontline email uhm.
Michael A. Sherman: Switching to the frontline AML trial. I know the trial is locked in and the patient characteristics are locked in, but have, What are your thoughts on expanding or maybe starting a separate phase 2 trial in an unfit population, maybe in combination with venerative clients or HMA or agents like that? Do you see it's a mechanistically, it's not something we should be thinking about. It's absolutely a mechanism.
File.
I know the trial is locked in on the.
Patient packed with the Lockton, but <unk>.
What are your thoughts on expanding or maybe starting a separate phase two trial in on fifth population maybe in combination with preventative class on each of me all the agents like the do you see it's <unk>.
<unk>, it's not something we should be thinking about.
It's absolutely a Mac and there's the mechanistic rationale for that and and I think it's part of our longer term development strategy I I think it's more likely that we would use the signal from the the 80 patient trial to trigger that that additional work that having been said the.
Michael A. Sherman: There's a mechanistic rationale for that, and I think it's part of our longer-term development strategy. I think it's more likely that we would use the signal from the 80-patient trial to trigger that additional work. That having been said, it's not without question that we could potentially start that earlier.
Not without question that we could that we could potentially the the <unk>.
Start that start that earlier it it's probably of loose connection, but the fact that that were seen evidence in D. Stat that the mechanisms involved with this drug or having intended of faxes it sort of builds our confidence in in in the the way the Strug works, albeit the difference in.
Michael A. Sherman: It's probably a loose connection, but the fact that we're seeing evidence in DSTAT that the mechanisms involved with this drug are having intended effects, it sort of builds our confidence in the way this drug works, albeit differently in an AML population. So our confidence is somewhat boosted by this early COVID data, but I think our focus for the moment is going to be on that frontline AML setting in combination with standard intensive therapy, and we'll confirm that we've got an MRD advantage. I think that opens the door for virtually any other combination and any other patient population setting in AML. Thank you again and congratulations on the program.
In in a M. L population. So so our our confidence is it somewhat boosted by this by this early early code the data, but I think our focus for the moment is gonna be on that the frontline M. L setting in combination with with the standard intensive therapy and let's confirm that.
We've got an M. R D advantage and I think that opens the door for really the virtually any other combination and and the and any other patient population setting and the amount.
Great. Thank you again and congratulations on the progress. Thank you.
Soumit Roy: Thank you. Your next question comes from the line of Joseph Cohn with Cowan and Company. Hi there.
Your next question kind of spend of mine of Joseph town went to Cowan and company.
Joseph John: Thank you for taking my questions. The first one was on the COVID data this morning. Congratulations on that.
Hi, there. Thank you for taking my questions. The first one on the the code of of data of this morning Uhm. Congratulations on that you did call. It a couple of imbalances between the arms, specifically on the need for for oxygen.
Michael A. Sherman: You did call out a couple imbalances between the arms, specifically the need for oxygen. How much of an impact do you think this could have? Do some physicians, I guess, intervene with oxygen, you know, more readily than others? I guess I'm just trying to get an idea of the real difference in severity between the two cohorts. And I guess going forward, is there a way that this might be able to be a little bit more balanced in the future cohorts that are going to be enrolled?
How much of an impact do you think this could be just some physicians I guess intervene with the oxygen you know more readily than than others. I guess I'm just trying to get an idea of really the the difference in the severity of between the two cohorts and I guess going forward is there a way that these might be able to be a little bit more balanced in the the future can work that are gonna be going on.
<unk>.
Yeah, Let me I'll give a quick answer and then let let the Allen speak to the medical treatment, but for sure that these are these are elements of stratification that we would apply as the the the cohorts are larger the the really when you've got 12 patients it's hard to apply <unk>.
Michael A. Sherman: Now, let me give a quick answer and then let Allen speak about the medical treatment. But for sure, these are elements of stratification that we would apply as the cohorts are larger. Really, when you've got 12 patients, it's hard to apply stratification factors. So age and baseline status on this NIAID scale are key stratification factors.
Application factor, so age and and baseline status on the this NAIAD scale are are key stratification Packers, let me, let Alan speak to the the way these patients are treated.
Michael A. Sherman: Let me let Allen speak to the way these patients are treated. Yeah, so all the patients were required to have a COVID-19 documented infection as well as be on supplemental oxygen. The difference was really between being on high flow oxygen versus standard supplemental oxygen.
Yeah. So all of the patients were required to have a COVID-19 document infection as well as being a supplement of oxygen. The difference was really between being on high for the auction versus standard stuff from the to oxygen Uhm I think it's important to also note that there are other balance at the did favorite the placebo on which was the.
Allen S. Melemed: I think it's important to also note that there were other imbalances that did favor the placebo arm, which was the DSTAT arm where all male patients would historically do a little worse in COVID-19. We didn't want to emphasize or overemphasize the results. We thought it was so compelling that we needed to release it. We are looking at the second cohort, and we want to see if it's similar to the trends seen. We're quite reassured, though, that we have not just the clinical evidence.
The deep debt arm had all male patients with historically do a little worse and didn't call the 19.
Uhm.
We didn't want to emphasize of overemphasize of the results. We thought it was so compelling that we needed to release. This we are looking at the second cohort N Y M C. With some of the trying to see where quite reassured, though that we had not just the clinical efficacy that we saw was correlated with the biomarkers and does that combination.
Uhm it actually exceed our expectations were expecting the safe that's something we knew from the D. M. C, who said safe to proceed to the next dose level, but we are quite reassured when you saw the efficacy and the biomarker. So this combination gave us confidence.
Allen S. Melemed: [inaudible] Great, thank you. And then maybe on 201, just thinking about how this could be incorporated into the treatment paradigm. You indicated it's already sort of on the sequencing panels. What sort of physician education, I guess, would be needed then?
Great. Thank you and then maybe on the on two of one just thinking about how this could be incorporated into the treatment paradigm, you indicated already sort of on the sequencing panels, what sort of a physician education I guess would be needed then could you move sequencing up earlier in and of patients diagnosis or is this gonna.
Joshua E. Allen: Could you move sequencing up earlier in a patient's diagnosis, or is this going to be pretty easy just once this drug is out there, and physicians know it's out there? It should see pretty good adoption. Josh, I'll go ahead and hand that one over to you, if you want to.
Be pretty easy just once the drug it out there and physicians know what's out there it should be pretty good adoption.
Josh I'll go ahead and hand that went over to you if you want to.
Answer that yeah. That's a great great question I think of <unk> important to note for this population is that uhm. The diagnosis is worked up from a tumor biopsy that debt is part of standard practice is now performed the diagnosis. So does not re biopsied, so really the sequencing events and other <unk>.
Joshua E. Allen: I think it's important to note for this population that the diagnosis is worked up from a tumor biopsy that is part of standard practice and is not re-biopsied. So really, the sequencing events and other molecular profiling technology that's used to identify the H3K27M mutation are already reflexively performed around the world at referral centers. And we've already seen, you know, very wide adoption of this following the definition of this disease that requires that molecular profiling, which was established in 2016.
<unk> the profiling technology, that's used to identify the ex three K twenty-seven M mutation, it's all ready reflexively perform around the world at referral centers and we've already seen Uhm you know very wide adoption of this following the definition of this disease that requires.
That that molecular profiling, which was established in 2016. So I think the profiling is already happening the profiling is already happening at diagnosis. So we don't need to move that that further upstream that's already of natural phenomenon and I think what we'll see over time is not a need for increased adoption because it's already there but rather.
Joshua E. Allen: So I think the profiling's already happening. Profiling is already happening at the time of diagnosis. So we don't need to move that further upstream. That's already a natural phenomenon. And I think what we'll see over time is not a need for increased adoption because it's already there, but rather more technologies that allow you to monitor the detection of the mutation without the need to go in and biopsy the tumor. So in other words, liquid biopsy, and we've already seen the first example of that with Foundation Medicine coming out with their FDA-approved liquid biopsy panels that include this mutation in sequence.
Increase technologies that allow you to monitor the detection of the mutation without the need to go in a biopsy the tumor so in other words liquid biopsy and we've already seen the the the first example of that with the foundation both of them coming out what they're up the a approved liquid biopsy panel that includes.
This mutation on sequencing.
Excellent. Thank you so much.
Michael A. Sherman: Excellent. Thank you so much. There are no further questions at this time. Now, I would like to turn the call back over to Mike Sherman for closing remarks. Once again, I appreciate everyone joining the call this morning and look forward to providing updates here in the coming weeks. Thank you. Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect. Thank you for watching!
And now for the questions at this time now I would like to turn the call back over to Mike Sherman for closing remarks.
Once again I appreciate everyone joining the the call. This morning, and look forward to providing updates here in the coming weeks. Thank you.
Ladies and gentlemen, this concludes today's conference call. Thank you for participating you may now disconnect.
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