Q3 2019 Earnings Call
Thank you for your patience.
Operator: Please stay on the line for the next available operator.
Please stay on the line for the next available operator.
unknown: My outro for my 20th birthday
Operator: Thank you for your patience. Please stay on the line for the next available operator.
Thank you for your patience.
unknown: Please see the complete disclaimer at https://sites.google.com or at www.sites.google.com.
Please stay on the line for the next available operator.
Thank you for your patience.
Operator: Thank you for your patience. Please stand in line for the next available operator. (inaudible)
Please stay on the line for the next available operator.
unknown: BF-WATCH TV 2021
Thank you for calling that every conference I'd number please.
Operator: Thank you for calling; the number you have dialed is currently unavailable at this time. Thank you. May I please have the spelling of your first and last name? D-A-V-I-D, David, B-R-O-W-N Brown. Thank you, sir. One moment.
169.
A tree 898.
Thank you ma'am. Please have the spelling of your first and last thing.
D E V I do you David.
Beat our old W. Brown.
Thank you Sir one moment.
Operator: And may I please have the spelling of your company's name? A-I-E-R-A-I-R-A. Thank you. Just to confirm, one last answer: first name, that's D-A-V-I-D, David.
And then Macy's and just filling of your company thing.
Eight I.E.R.A. I era.
Thank you I'll just to confirm wireless answer first thing and that's a D V I'd.
<unk>.
Operator: Last name Brown, B-R-O-W-N. Is that correct? Yes, correct. Alright, thank you, sir. I'll join you now.
David last.
On the R O W.
Yes, correct.
Great. Thank you Sir I'll join you know.
Michelle LaSpaluto: Thank you. These forward-looking statements are within the meaning of the Private Securities Litigation Reform Act of 1955 and are subject to risks and uncertainties and other factors. These risks and uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. You are cautioned not to rely on these forward-looking statements. These risks and uncertainties are described in detail in Chimerix's filings with the Securities and Exchange Commission, including its Form 10-Q, filed earlier today, its most recently filed report on Form 8-K, and other documents subsequently filed with the SEC. All forward-looking statements are based on information currently available at Chimerix, and Chimerix assumes no obligation to update any forward-looking statements. With that said, I will now return the call to Mike Sherman. Mike?
Thank you.
And the meaning of the private Securities Litigation Reform Act of 19 type 1955, and are subject to risks and uncertainties and other factors. These risks and uncertainties. Other factors could cause actual results to differ materially from those referred to in the forward looking statements. You are cautioned not to rely on these forward looking statements. These risks and uncertainties are described in detail in comerica filings with the securities.
Exchange Commission, including a Form 10-Q filed earlier today. Its most recently filed reports on form 8-K, and other documents subsequently filed with the Securities and Exchange Commission.
All forward looking statements are based on information currently available time their income accessing no obligation to update any forward looking statements.
With that I now are we turn the call over to Mike Sherman Mike.
Michael A. Sherman: Thanks, Michelle. Good morning, everyone, and thanks for joining us. As I reflect on what the organization has accomplished in the six months since I joined, I'm really pleased with the new track record of execution we're creating. In that short time, we've completed an objective assessment of all our activities and restructured the organization to maximize resources available to invest in those programs with the potential to have the biggest impact on the largest populations of patients with the greatest need. For the activities we've stopped, we did that efficiently and compassionately as we continued to support patient access to brinsadopavir. We've identified and acquired an exciting drug with the potential to fundamentally change the way AML patients are treated immediately following diagnosis, the point at which durable benefit is most meaningful and, frankly, elusive to patients. For Brinsad Afavir, we've aligned with BARDA and the FDA on the remaining experiments to be performed prior to a pre-NDA meeting. We've even agreed on what we'll include in the NDA, so that work is well underway.
Thanks, Michelle good morning, everyone and thanks for joining us as I reflect on what the organization has accomplished in the six months since I joined really pleased with the new track record of execution, we're creating.
And that short time, we've completed an objective assessment of all our activities and restructured the organization to maximize resources available to invest in those programs with the potential to have the biggest impact on the largest populations of patients with the greatest need.
For the activities, we stopped we've we've done that in and if efficiently and compassionately as we've continued to support patient access to Brincidofovir.
We have identified and acquired an exciting drugs with the potential to fundamentally change the way M.L. patients are treated immediately following diagnosis the point at which durable benefit as most meaningful and frankly elusive to patients.
For Brincidofovir, we've aligned with BARDA and the F.D.A. on the remaining experiments to be performed prior to a pre NDA meeting.
We'd even aligned on what will include in the end yea, So that work is well underway.
Michael A. Sherman: The final Brent Sadafovir studies, those dose-bridging studies, are also underway and going well. While the opportunities for brining you off your product outside of smallpox do not fit our strategy, we recognize that there may be value there for patients and shareholders. So, we identified a partner in Symbio who is already aggressively pursuing the spin-off of your development in other viral indications. So, with two Phase III assets in hand, we look forward to the next six to nine months with the same sense of urgency and commitment to disciplined execution we've demonstrated recently.
The final Brincidofovir studies those dose bridging studies are also underway and going well.
While the opportunities for Brincidofovir outside of smallpox do not fit our strategy. We recognize that there may be value there for patients and shareholder. So we identified a partner in some bio who is already aggressively pursuing brincidofovir development and other viral indications.
So with two phase three assets in hand, we look forward to the next six to nine months with the same sense of urgency and commitment to disciplined execution, we've demonstrated recently.
Michael A. Sherman: This timeframe is rich with patient-focused, value-driving catalysts. For DSTAT, we will meet with the FDA to align on our plans for a pivotal Phase III trial in first-line AML, and we expect to initiate that trial mid-year next year. For Brent Sadafovir, we'll meet with the FDA to discuss our planned NDA submission. Success in that meeting sets the stage for a procurement process to add Brent Sadafovir to the national stockpile as a countermeasure for smallpox. This is not only an important step for national security but can translate to hundreds of millions of dollars of non-dilutive funding for the company. To be clear, we're positioning our manufacturing plants to deliver up to $100 million worth of product to the stockpile before the end of 2021.
This time frame as rich with patient focused value driving catalyst for D. Stat, we will meet with the FDA till a line on our plans for a pivotal phase three trial in first line ml and we expect to initiate that trial mid year next year.
For Brincidofovir will meet with the FDA to discuss our planned Andy a submission success and not meeting sets the stage for a procurement process to add brincidofovir to the national stockpile as a counter measure for smallpox.
This is not only an important step for national security, but can translate to hundreds of millions of dollars of non dilutive funding for the company.
To be clear, we're positioning our manufacturing plants to deliver up to $100 million worth of product to the stockpile before the end of 2021, So we're certainly planning and preparing for success.
Michael A. Sherman: So we're certainly planning and preparing for success. Before I hand it over to Garrett, I'd like to make a few more observations about the D-STAT program and AML. I'm having a little deja vu with prior experience in prostate cancer when, following the approval of a handful of therapies five to seven years ago, there was this perception that little opportunity remained in that indication. However, in that case, despite the benefit provided by those therapies, the disease would ultimately progress, leaving a new void of options for patients. Physicians and investors have since recognized the enormous value that remains to first prevent and then treat metastatic prostate cancer.
Before I hand, it over to get let me make a few more observations about the D stat program and AML.
I'm, having a little deja vu with prior experience in prostate cancer. When following the approval of a handful of therapies five to seven years ago. There was this perception that little opportunity remained in that indication.
However in that case, despite the benefit provided by those therapies the disease would ultimately progress, leaving a new void of options for patients.
Physicians and investors have since recognize the enormous value that remains to first per event and then treat metastatic prostate cancer AML presents a similar story with a flurry of approvals of targeted agents addressing niche populations of patients and then therapies for relapse and.
Michael A. Sherman: AML presents a similar story with a flurry of approvals of targeted agents addressing niche populations of patients and then therapies for relapse and refractory disease. However, perceptions among some are that the opportunity for new therapies is limited. However, a physician I spoke with recently reminded me that in AML, there's nothing complete about a complete response. While some patients are responding to treatments, these responses are typically short, and five-year survival rates in older patients remain less than 10%. We still have a lot of work to do for these patients. While others are pursuing highly targeted mechanisms, we believe that in an indication such as AML, where there is tremendous heterogeneity of disease, even within a patient, more durable responses and higher cure rates will require mechanisms that are multimodal.
Refractory disease perceptions, among some are that the opportunity for new therapies is limited.
Over a physician I spoke with recently reminded me that Enamelled, there's nothing complete about a complete response.
While some patients are responding to therapies. These these responses are typically short and five year survival rates in older patients remain less than 10%. We still have a lot of work to do for these patients while others are pursuing highly targeted mechanisms. We believe that in indications such as am malware there.
As a tremendous heterogeneity of disease, even within a patient more durable responses and higher cure rates will require mechanisms that are multi modal.
Michael A. Sherman: And the best chance to apply that multimodal mechanism is in the first line of treatment where the intent is still curative. What excites us about D-STAT mechanistically is that it targets multiple proteins that have been implicated in the survival of leukemic blasts and leukemic stem cells and even mechanisms that delay hematologic recovery in these patients. As Garrett will describe in more detail, DSTAT improves the most important clinical parameters for patients, time without disease, and overall survival. These are also important regulatory improvements. No matter how we slice the randomized phase 2 data for DSTAT, the evidence of more durable responses persists. Delivering that benefit in a therapy that doesn't add materially to toxicity makes its potential that much more attractive, which is, of course, why we're eager to complete the planning for phase three and get that trial enrolling. With that, let me turn the call over to Garrett to discuss the final Phase 2B results of D-STAT and some updates on Prince Sadafivir.
And the best chance to apply that multi modal mechanism is in the first line of treatment, where the intent is still curative.
What excites us about D. Stat Mechanistically is that it targets multiple proteins that have been implicated in survival of leukemic blasts, and leukemic stem cells, and even mechanisms, which delay hematologic recovery in these patients.
Garrett will describe in more detail D stat improves the most important clinical parameters for patients time without disease and overall survival and these are also important regulatory endpoints.
No matter, how we slice the randomized phase two data for D stat, the evidence of more durable responses persists.
Delivering that benefit in a therapy that doesn't add material to tux materially to toxicity makes it potential its potential that much more attractive which of course is why we're eager to complete the planning for phase three and get that trial enrolling.
With that let me turn the call over to get to discuss the final phase to be results of D. Stat in some updates on brincidofovir.
Garrett: Thank you, Mike, and good morning to all of you. In October, we presented final results from the recently completed Phase IIb randomized controlled trial of DSTAT in AML. The study evaluated GSTAT given as a 4 mg per kg intravenous bolus followed by either 0.125 or 0.25 mg per kg per hour continuous IV infusion for 7 days. These were in combination with standard 7 plus 3 chemotherapy versus that 7 plus 3 chemotherapy alone in 75 subjects greater than 60 years of age with newly diagnosed AML. An analysis of the intent-to-treat, or ITT, population in this study indicated that patients receiving the high dose, 0.25 mix per kick per hour of DSTAT, exhibited improved hazard ratios for event-free survival, overall survival, and relapse-free survival when compared to control patients, and Analysis of Subjects that Meet the Likely Target Inclusion Criteria for the Phase 3 Study, which will exclude patients with favorable cytogenetics or secondary AML, also showed improved observed hazard ratios for DSTAT high dose versus control, with a median follow-up of 19.6 months.
Thank you, Mike and good morning to all of you.
In October we presented final results from the recently completed phase to be randomized controlled trial of D stat in AML.
The study evaluated D stat, given as a four mig protect intravenous bolus.
Followed by either 0.1 to five or 0.25 mix for kick for our continuous Ivy infusion for seven days.
These were in combination with standard seven plus three chemotherapy versus that seven plus three chemotherapy alone in 75 subjects greater than 60 years of age with newly diagnosed AML.
An analysis of the intent to treat were ITC population in this study indicated that patients receiving the high doses. Your 0.25 mixed per keurig per hour of D. Stat exhibited improve hazard ratios for event free survival overall survival and relapse free survival when compared to control patients.
An analysis of subjects that meet the likely target inclusion criteria for the phase three study, which will exclude patients with favorable cytogenetics or secondary AML.
Also showed improved observe hazard ratios for D stat high dose versus control.
With a median follow up 19.6 months the hazard for event free survival was 0.58.
Garrett: The hazard for event-free survival was 0.58. Overall survival had a hazard ratio of 0.51, and the relapse-free survival hazard ratio was 0.39, all improved for the high-dose DSTAT arm versus control. These results suggest that durable responses were associated with the addition of D-STAT to standard 7 plus 3 therapy. Combination treatment with 7 plus 3 therapy and DSTAT did not show any significant added toxicity at either dose. The most common serious adverse event in the DSTAT arm was febrile neutropenia. However, there was no increase in the incidence of serious or non-serious infectious events in the high-dose DSTAT arm when compared to control.
Overall survival had a hazard ratio of 0.51, and the relapse free survival hazard ratio was 0.39.
All improved for the high dose D stat arm versus control.
These results suggested durable responses were associated with the addition of D stat to set standards seven plus three therapy.
Combination treatment was seven plus three therapy and D. Stat did not show significant added toxicity either debts.
Most common serious adverse event in the D stat arm, which febrile neutropenia.
However, there was no increase in the incident of serious or non serious infectious events on the high DSD stat on when compared to control.
Garrett: These stats also showed no additive hematologic toxicity, which is the case for virtually all other add-on therapies that have been tried with 7 Plus 3 chemo, but rather showed signs of accelerating platelet and neutrophil recovery following chemotherapy. This may be consistent with its in vitro activity against platelet factor four. We expect to initiate a Phase III clinical trial of D-STAT for the treatment of AML in mid-2020, subject to discussions with the FDA in early 2020. On the smallpox front, we are on the cusp of major milestones that build upon announcements that we made earlier this year regarding the statistically significant and clinically meaningful reduction in mortality in our GLP mousepox and rabbitpox studies. I've just returned from the 21st Annual Meeting of the Advisory Committee on Variola Virus Research, which was held at WHO from the 30th of October to the 1st of November in Geneva, Switzerland.
These that also showed no additive hematologic toxicity, which is the case for virtually all other add on therapies that have been tried with seven plus chemo.
But rather showed signs of accelerating platelet and neutrophil recovery following chemotherapy.
This may be consistent with its in vitro activity against platelet factor for.
We expect to initiate a phase III clinical trial D stat for the treatment of AML in mid 2020 subject to discussions with the FDA in early 2020.
On the smallpox front, we are on the cost of major milestones to build upon announcements that we made earlier this year regarding the statistically significant and clinically meaningful reduction in mortality in our GLP mass pocs and rabbit pox settings.
I've just returned from the 21st annual meeting of the Advisory Committee on very old a virus research, which has held at the WH. So from the Thirtyth of October to the first of November in Geneva, Switzerland.
Garrett: On this, the 40th anniversary of the year that smallpox was eradicated worldwide, the WHO recognized many significant achievements that have been made in antiviral and vaccine countermeasures. However, the WHO highlighted the need for at least one other antiviral with a different mechanism of action in order to facilitate therapy for treatment emergent resistance, or more importantly, for bioweapons that are engineered to have resistance to the currently available therapy. Bryn Sadafovir fits that need and is the only agent that could deliver to the strategic national stockpile in the near term, with others very early in development and many years away. We are working diligently on the final reports to support approval and plan a pre-NDA meeting with the FDA in the first quarter of 2020.
In this the 40 at anniversary of the year that smallpox was eradicated worldwide. The whr recognized many significant achievements that have been made an anti viral and vaccine countermeasures.
However, the WH you highlighted the need for at least one other anti viral with a different mechanism of action in order to facilitate therapy for treatment emergent resistance or more importantly for bio weapons that are engineered to hop resistance to the currently available therapies.
Brincidofovir fits that need and is the only agents that could deliver to the strategic national stockpile in the near term with others very early in development in many years away.
We're working diligently on the final reports to support approval and plan a pre NDA meeting with the FDA in the first quarter of 2020.
Garrett: In the meantime, we continue to provide Brin Sadafavir for treatment of serious orthopoxvirus infections via our Expanded Access Program, including cases that have occurred in the past few months. Though uncontrolled, these experiences may help us build the rationale for the licensure of Brent Sadovivir and the inclusion of Brent Sadovivir in the strategic national stockpile. I'll now turn the call over to Mike Andriole for a review of the financials.
In the meantime, we continue to provide brincidofovir for treatment of serious or the pox virus infections via our expanded access program, including cases that have occurred in the past few months.
Though uncontrolled these experiences may help us build the rationale for the licensor of Brincidofovir and the inclusion of Brincidofovir in the strategic National stockpile.
I'll now turn the call over to Mike Andriole for review of the financials.
Michael T. Andriole: Thanks, Garrett, and good morning, everyone. Let me give you some highlights of the financial results we released this morning. Starting with our balance sheet, at the end of the third quarter 2019, we remained well capitalized with $116.7 million of capital available to fund operations, no debt, and approximately 61.4 million shares of common stock outstanding. The cash balance at the end of the third quarter reflects the upfront payment of $30 million made to Cantext for the license to DSTAT but does not include the $5 million owed from Symbio, which was classified as a receivable on The company reaffirmed its previous guidance of approximately $110 million in cash and cash equivalents at the end of 2019.
Thanks, Gary and good morning, everyone.
Let me give you some highlights of the financial results. We released this morning.
Starting with our balance sheet at the end of the third quarter 2019, we remain well capitalized with $116.7 million of capital available to fund operations, no debt and approximately 61.4 million shares of common stock outstanding.
The cash balance at the end of the third quarter reflects the upfront payment of $30 million were moved to Camteks for the license to boost but does not include the $5 million over from some bio which was classified as a receivable at September thirtyth due to retirement of the transaction.
The company reaffirms its previous guidance of approximately $110 million and cash cash equivalents at the end of 2019.
Turning to the statement of operations, the only or who's rollout in the highlight is the acquired and process R&D expenses.
$1 for the quarter, which was related to the Camteks transaction.
Michael T. Andriole: Turning to the Statement of Operations, the only unusual item to highlight is the acquired and processed R&D expense of $65 million for the quarter, which is related to the Cantext Transaction. This is mainly comprised of the $30 million up front that we paid up front, and $34.9 million non-cash stock compensation expense related to the $10 million shares of common stock included in the transaction.
Was mainly comprised of the $30 million up from.
Repaid.
Upfront and 34.9 million noncash stock compensation expense related to the 10 million shares of common stock.
I'm sorry.
Looking forward as I noted earlier in the year. It has been our goal to meaningfully improve the underlying cash burn rate for the company. Following our Q2 restructure announcements we've been successful in that effort and forecasting eggs do you see annualized cash burn rate just north of $20 million as we exit the year.
Michael T. Andriole: Looking forward, as I noted earlier in the year, it has been our goal to meaningfully improve the underlying cash burn rate of the company following our Q2 restructuring announcement. We've been successful in that effort, and forecast an ex-DSTAT annualized cash burn rate just north of $20 million as we exit. I'd like to finish today by reiterating our confidence in our new strategic direction. The significant progress we have made over the last several months has positioned us well for the balance of the year and beyond. We successfully transitioned our clinical pipeline to deliver a number of near-term, value-creating milestones. As we look toward 2020, key inflection points we plan to reach include a meeting with U.S. regulatory authorities to confirm our Pivotal Phase III study protocol for DSTAT and first-line AML. Initiating the D-STAT Phase 3 Pivotal Study Mid-Year. Submission of the marketing application for Brincidafavir as a medical countermeasure for smallpox, and Securing a Procurement Contract with BARDA to Add Brinz Adafovir to the U.S. Strategic National Stockpile, and, in the process, Transitioning the Company to a Commercial Stage. With that, Operator, we'll now open the line for questions.
I'd like to finish today by reiterating on toppings and on the strategic direction.
The significant progress we've made over the last several months has positioned us well for the balance of leader and beyond.
Successfully transitioned our clinical pipeline to deliver a number of near term value, creating milestones as we look towards 2020 key inflection points. We plan to reach include a meeting with us regulatory authorities to confirm or pivotal phase three study protocol produced in first line email.
Initiation of these phase three pivotal studies mid year.
Submission of the marketing application for Brincidofovir as a medical countermeasure for smallpox and securing a procurement contract with BARDA goods is off to the euro strategic national stockpile and in the process transitioning company into a commercial stage spartech.
With that operator, we'll now open the line for us.
Ladies and gentlemen to ask a question you'll need to press star one on your telephone to withdraw your question press the pound Keith Please standby well, we compile the Q and a roster.
And our first question comes from Ed White with H.C. Wainwright. Please proceed with your question.
Hi, guys. Thanks for taking my question.
Sure.
Hi, just on D stat.
Since the.
Sure you're looking at the standard seven plus three chemotherapy in front line.
It appears that the.
The study shouldn't real quickly I am just wanted to get your thoughts on.
I know you haven't talked the FDA your thoughts on.
Operator: Ladies and gentlemen, to ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound key. Please stand by while we compile the Q&A roster. And our first question comes from Ed White with HC Wainwright. Please proceed with your question.
Perhaps the number of patients.
That you'd need for FDA submission.
And what could be.
The timing for.
For completion of the of the study.
Yeah. This is Mike do you kind of hit the first part of the answer to the fact that we haven't talked to the FDA yet will cause me to be somewhat cautious, but I guess I could point too.
Edward Patrick White: Just on DSTATS. You know, since you're looking at the standard 7 plus 3 chemotherapy regimen in the front line, it appears that the study shouldn't move quickly. I'm just wanting to get your thoughts on, you know, I know you haven't talked to the FDA yet, but your thoughts on perhaps the number of patients that you'd need for an FDA submission and, you know, what could be the timing for completion of the study.
Theres that theres at least one NC IDE study.
Being conducted in this in this space that.
I think its and rolling 570 patients I don't think thats too far out of the scope of of what we would consider certainly is as we discuss endpoints with the FDA, we're exploring opportunities to be.
As expeditious with that strategy as we as we can so I think it I think we'll get through that discussion alignment on the end points and then we'll have a better opportunity too.
Michael A. Sherman: Yeah, this is Mike. You kind of hit the first part of the answer. The fact that we haven't talked to the FDA yet will cause me to be somewhat cautious, but I guess I could point out that there's at least one NCI study being conducted in this space that I think is enrolling 570 patients. I don't think that's too far out of the scope of what we would consider. Certainly, as we discuss endpoints with the FDA, we're exploring opportunities to be as expeditious with that strategy as we can. So I think we'll get through that discussion alignment on the endpoints, and then we'll have a better opportunity to describe the timelines involved. I will say that our plan is to use as many sites and in as many countries where standards of care are consistent to be able to enroll that in a really timely manner. So we'll report on that as we've confirmed those endpoints.
To describe the the timelines involved I will say that are our plan is to.
To use as many sites and in many as many countries where standards of care consistent to be able to enroll that and really timely manner.
So so we'll report on that as we've confirmed those endpoints.
Great. Thanks, Mike.
And.
Maybe.
A question just on the Symbio.
Agreement.
You have milestones for future clinical regulatory and commercial.
Endpoint initiation so are there any milestones.
For the clinical trial initiation.
Or you're going to have to wait for data I'm, just trying to get an idea for for timing for some of these upcoming milestones.
Edits like Israel.
Edward Patrick White: Great. Thanks, Mike. And maybe a question just on the CINBIO agreement. You have milestones for future clinical regulatory and commercial end points.
We don't forecast any milestones in the coming years related related to.
A milestone package.
But it will but that obviously.
Michael T. Andriole: For the clinical trial initiations, you know, or are you going to have to wait for data? I'm just trying to get an idea of the timing for some of these upcoming milestones.
Obviously, we will start in Japan.
Development.
Spend.
Globally.
Okay. Thanks.
And then just.
As far as the.
Brings to the cost of year for smallpox.
Edward Patrick White: Ed, it's Mike Andriole. We don't forecast any milestones in the coming years related to The Milestone Pack. That, obviously, will start with Japanese development and will expand. Go away for a minute.
You are going to meet with with the FDA and Thats sets the stage set for the procurement contract, but you don't need the FDA approval for the procurement contract. So.
Michael A. Sherman: Okay, thanks. And then only as far as the brief synopositive for smallpox. You're going to meet with the FDA, and that sets the stage, you said, for the procurement contract, but you don't need FDA approval for the procurement contract. So I'm just wondering if you've been meeting with, [inaudible] You do need FDA approval for sales outside of the U.S. for stockpile. Have you talked to any countries outside of the U.S. for potential procurement contracts yet?
Im just wondering if you if youve been meeting with.
The.
With the government in order to see where you stand for the term contract or just any update there for the the actual.
Decision makers are currently contract.
Then also have you been talking too I know.
You do need to FDA approval.
For sales outside of the U.S. fourth stockpiling have you talk to any countries outside the us for potential procurement contract yet.
Michael A. Sherman: So, on the first question, we do stay in close contact with the leadership at BARDA. And while, you know, they could, could trigger the stockpile independent of the FDA process, they've been pretty, well, they've been very clear and very consistent that they'd like to get to the other side of that pre-NDA meeting, just to confirm that there's alignment with the FDA to move ahead with the filing. So they're not going to wait until the submission or, necessarily, certainly until approval but just want to get alignment with the FDA that we've done the work that's necessary.
So on the first question, we do stay in close.
Contact with the leadership at that BARDA and.
While they could can trigger the.
The stockpiling independent of the FDA process they've been pretty.
Mobile has been very clear and very consistent that they'd like to get to the other side of that.
That pre NDA meeting just to confirm that there's alignment with the FDA to move ahead with the filing of the so they're not going to wait.
Until this submission or necessarily.
Certainly until approval, but just want to get alignment with the FDA that we've done the work. That's that's necessary I would add that are our dialogue with the FDA in the meantime has has been as much about.
Michael A. Sherman: I would add that our dialogue with the FDA, in the meantime, has been as much about preparing for and ensuring alignment on what's to be included in the NDA, and so I view that as positive, at least as it relates to their view of the work that we've done to date. I'll also add that, you know...
What kind of preparing for and ensuring alignment on what's to be included in the end da and so I I view that as as positive at least as it relates to on a very their view on the work that we've done today I'll also add that.
Michael A. Sherman: The last time we provided an update, we had not initiated some of these final dose bridging studies that are required before we go to that pre-NDA meeting. And so the fact that those have initiated with early signs is good in terms of what we're seeing is certainly positive work to be done there, but I think we've put some risk behind us as we've continued to execute on that. As it relates to opportunities outside the U.S. for selling brined off here for stockpileing or other purposes, our focus, frankly, has been on the U.S., as you can imagine. There have been various exchanges with other parties outside the U.S., and I think there are opportunities there. I would argue that the largest opportunity, though, is going to be in the U.S., where you've seen contracts, historical contracts, in the $400 million to $500 million-plus range. And as I mentioned in my comments previously, we've positioned ourselves to be able to supply up to $100 million into a stockpile should we secure a procurement agreement so we can deliver that much product before the end of 2021. It ends up being an important mechanism for funding the organization.
Last time, we provided an update we had not initiated some of the these final dose bridging studies that are required before we go to that pre NDA meeting.
And so the fact that those have initiated and early signs or are are good in terms of what we're seeing is certainly positive work to be done there, but I think the.
Weve I think put some risks behind us as Weve continued to execute on that as it relates to outside the us opportunities for.
Selling selling brincidofovir for stockpiling or other purposes, our focus frankly has been on on the U.S. as you can imagine.
There there have been thing various exchanges with other parties outside the us and I think there are opportunities there.
I would I would argue that the largest opportunity, though is going to be.
In the us where you've seen contracts historical contracts and four to 500 million dollar plus range.
And as I mentioned in my in my comments previously, we positioned ourselves to be able to supply up to $100 million into the stockpile should we secure a procurement agreement.
So we can deliver that much product before the end of 2021, it ends up being an important mechanism to funding the organization.
Great. Thanks, Mike.
Edward Patrick White: Great. Thanks, Mike.
Operator: Thanks, Ed.
Thanks, Ed.
Kenneth Atkins: Thank you. And our next question comes from Kenneth Atkins. Please proceed with your question.
Thank you and our next question comes from Kenneth Kim. Please proceed with your question.
Michael A. Sherman: Hi. Thanks for taking my questions. I'm just wondering if you could comment on how you anticipate D-STEP would fit into the treatment paradigm for AML. You kind of hinted at this in your comments about potentially excluding patients with low-risk cytogenetics or secondary AML in the Phase III trial. Could you just comment on that?
Hi, Thanks for taking my questions I'm, just wondering if you could comment on how you anticipate do step would fit into the treatment paradigm for AML you kind of hinted at this in your comments about potentially excluding patients with low risk credit genetics or secondary AML and the in the phase three could you just comment on that.
Michael A. Sherman: Yeah, so as we look at older patients who are fit for chemotherapy, these are patients that are currently being treated with 7 plus 3 chemotherapy. There are some additional add-on therapies that are used, some of the targeted therapies. And in patients with favorable cytogenetics, for example, these are patients that typically receive a drug called Mylotarg in addition to 7 plus 3 therapy. As far as secondary AML or AML that arises from myelodysplastic syndromes, those patients are licensed to receive Vixios, which is the liposomal formulation of 7 plus 3 therapy. So in order to simplify the study, in order to have one standard background therapy of Cytarabino 7-day infusion plus 3 days of an anticycline, either Idarubicin or Donarubicin, we would exclude those patients up front.
Yes, so as we look at an older patients who are fit for chemotherapy. These are patients that are currently treated with seven plus three chemotherapy. There are some some additional add on therapies that are that are used some of the targeted therapies.
And in patients with favorable size said signage and X. For example, these are patients typically receive a drug called Mylotarg. In addition to seven plus three therapy as far as the secondary AML or the ammo that arises from from modest plastic syndromes. Those patients are licensed to receive Vyxeos, which is the liposomal.
Some of formulation of seven plus three therapy.
So as a in order to simplify the the study in order to have one standard background therapy of.
Cytarabine seven day infusion plus three days of an asset cycling either I'd Aruba Center Donna Robison.
We would exclude those patients upfront.
Michael A. Sherman: One of the attractive things about the therapy is that really, for any patient that or any other therapy that could benefit or be augmented by the movement of the lymph leukemic blasts or even the stem cells into circulation where they can be exposed to therapy, this is a viable combination. The overlapping toxicities Given the safety of the drug, should allow us to combine it with virtually anything there, and our development plans would be to expand that. There's also some interesting science suggesting that there's potential to resensitize patients who may be resistant to prior therapies, and so we're going to explore that as both a mechanism to expand the indication opportunity but also to generate data which I think could be catalysts or momentum for the drug in the meantime while phase 3 is enrolling.
One of the attractive thinks about the therapy is that.
Really for.
Any patient that or any other therapy that could benefit or be augmented by the.
The movement of.
The link leukemic blasts or even the stem cells into circulation, where they can be exposed to therapy. This is a viable combination the.
The the overlapping toxicities, given the safety of the drug.
Should allow us to combine with virtually anything there and our development plans would be to expand that there's also some interesting.
Science, suggesting that there's potential to.
To re sensitized patients who may be resistant to.
Two prior therapies and so we're going to explore that as both a mechanism to expand the indication opportunity, but also to generate data, which I think can be catalysts are momentum for for the drug in the meantime, while the phase three is enrolling.
Michael A. Sherman: Yeah, just to specifically address the VIXIOS population. VIXIOS did improve outcomes in those secondary AML patients compared to standard chemotherapy. The magnitude of the benefit was small, and it was associated with worse or slower hematologic recovery. Hence, those patients also had to stay in the hospital longer, et cetera. There's no reason why the D-STATS mechanism would not be beneficial in patients who are receiving VIXIOS, and we've indeed been approached by a number of physicians who are interested in exploring that combination. Just, we're focusing on this first phase three trial as our near-term deliverable, and then certainly we'll be looking at other combinations in AML and potentially other hematologic malignancies down the road.
Yes, just it just is specifically addressed the vyxeos population Vyxeos did improve outcomes in the secondary AML patients compared to two to standard chemotherapy. The magnitude of the benefit was was small and it was associated with.
Worse.
Were slower hematologic recovery. So this patients also had to stay in hospital longer et cetera, Theres. No reason why these stats mechanism would not be.
Beneficial in patients who are receiving vyxeos than we have indeed been approached by a number of physicians who are interested in exploring that combination.
Just where we're focusing on this first phase III trial as our near term deliverable and then certainly will be we'll be looking at other combinations.
In in AML and potentially other hematologic malignancies down the road.
Kenneth Atkins: Okay, thanks, that's very helpful. Thank you.
Okay. Thanks, that's very helpful.
Thank you.
Operator: Thank you, and I'm not showing any further questions at this time. I will now turn the call over to Mike Sherman for any further remarks.
Thank you I'm not showing any further questions at this time I'll now turn the call over to Mike Sherman for any further remarks.
Michael A. Sherman: Great, thanks everyone again for joining the call this morning. Before we close, I'd like to highlight a couple of upcoming presentations. We'll be at the Credit Suisse Conference in Phoenix on November 13th and then at the Jeffries Conference in London on November 20th. So we look forward to seeing some of you there and updating you on our progress in the coming months. Have a good day.
Great. Thanks, everyone again for joining the call. This morning before we close I'd like to highlight a couple upcoming credit presentations will be at the credit Suisse Conference in Phoenix on November 13th and then at the Jefferies Conference in London on November Twentyth. So we look forward to seeing some of you there and.
And updating you on our progress in the coming months.
Good day.
Operator: Ladies and gentlemen, this concludes today's conference. Thank you for participating. You may now disconnect.
Ladies and gentlemen. This concludes today's conference. Thank you for participating you may now disconnect.
unknown: The Ultimate Parody Site!
unknown: BF-WATCH TV 2021