Q1 2020 Earnings Call
[music].
Ladies and gentlemen, thank you for standing by and welcome to the other [laughter] first quarter 2020 ever search results conference call at this time [laughter] Arnaud listen only mode.
'cause, it's because presentation there will be a question answer session to ask a question. During this session you would need to press star one and your telephone if he require any further system. Please press star zero I would now like to hand, the conference over to your speaker today Karen. Thank you. Please go ahead.
Thank you Casey and good afternoon, everyone.
As Kathy mentioned I'm, Karen Oddity director of corporate Communications, and Investor relations for out or says.
Thank you for joining today's call. If you do not have a copy of the press release issued at the close of market. It is available on the other shifts website at Athersys dotcom.
For me cloud Chief Financial Officer, if you're to provide us with the financial update and Gil Van Bokkelen, Chairman and Chief Executive Officer will be providing our corporate update.
Today's call is expected to last 30 to 45 minutes and a webcast of the audio wholl be available two hours after the call. Its conclusion on our website under the events section the access information for the replay is also in today's press release.
Any remarks that we may make about future expectations plans and prospects constitute forward looking statements for purposes of the safe Harbor provision under the private Securities Litigation Reform Act of 1995.
Actual results may differ materially from those indicated by the forward looking statements as a result of various important factors, including those discussed in our form 10-Q, 10-K, and other public SEC filings.
We anticipate that subsequent events and developments may cause our outlook could change while we may elect to update those forward looking statements at some point in the future, we specifically disclaim any obligation to do so.
For the benefit of those who maybe listening to the replay of this call was held and recorded on may 7th of Twentytwenty.
Since then we may have made announcements related to the topics discussed. So please reference our most recent press releases and does he see filing.
With that I'd like to turn the call over to Ivor Mcleod Ivor.
Thanks Scott.
[noise] good afternoon, everybody and once again, thank you for joining today's cool.
Either Mcloughlin, Chief financial Officer practices and it is my pleasure to give you an overview of the financial results for the first quarter 2020.
We did not recognize any revenue for the three months ended March 31st 2020.
Compared to $1.4 million for the three months ended March 31st 29 tea.
The revenues in the prior period, which generated from our collaboration with Healios related to manufacturing services before.
We do expect or collaboration revenues to vary over time, as we contracted healios to perform manufacturing services or engage and other activities and asked we potentially enter into new collaborations.
Research and development expenditures were $12.1 million for the first quarter 2020.
A 700000 dollar increase over the 11.4 million expenditure in the comparable period in 2019.
The 700000 dollar increase is associated with increases in internal research supplies of 700000.
Personnel costs of 300000.
Outside services 200000 consulting costs of 100000.
Stock compensation costs of 100000.
Other research and development cost 200000.
These increases partially offset by decreases in clinical trial and manufacturing process development costs of 900000.
Our clinical development clinical manufacturing and manufacturing process development expenses vary over time based on the timing of stage of clinical trials underway.
Are you factoring campaigns for clinical trials and manufacturing process development projects.
We do expect our annual 2020 clinical develop costs to increase as compared to 2019.
General and administrative expenses were 3.5 million for the three months ended March 30, Onest 2020.
An increase of $400000 compared to the 3.1 million in the comparable period in 2019.
The 400000 dollar increase was primarily due to increased personnel costs outside services and stock compensation costs.
Our net loss for the first quarter 2020 was $15.6 million compared to a net loss was $13 million in the first quarter of 2019.
The difference is a consequence of the previously mentioned variances.
During the three months ended March 31st 2020, net cash used in operating activities was $12.1 million compared to 5.5 million in three months ended March 31st 2019.
At March 30, Onest 2020, we had $32.7 million in cash and cash equivalents.
Compared to $35 million at December 31st 2019.
It is important to note that our March 31st 2020 cash cash equivalents balance does not include the receipt of approximately $7 million in connection with the Healios warrant exercise.
Nor does it include the proceeds of our recent public offering which were $57.6 million gross.
Before I turn the call over to Gil I did want to address assets. This is participation in the paycheck protection program the PPP.
Established as part of the Kazakh the Corona virus aid relief and economic Security Act.
Based on the initial guidance issued by the us to pump to the treasury emphasis met the criteria of a qualifying business and applied for and was approved for loan of $1.3 million.
Following the approval of below the Treasury Department issued revised guidance, indicating the public companies may not be eligible for PPP lows.
As a consequence, we did not except the 1.3 million dollar and the proceeds were returned to the small business administration.
With that I will turn the call over to go for the corporate update Gill.
Thanks Ivor.
Since our last earnings call held only seven weeks ago, the world has changed and some meaningful and unfortunate weights.
At that time in mid March there were approximately 180000 confirmed cases globally of Kobin 19 infection.
And 7200 confirmed patient debt.
As of today, there have been more than 3.85 million confirmed cases of cobot 19 infection and approximately 266000 patient deaths have occurred globally.
This includes $1.25 million confirmed cases, and approximately 74000 patient deps here in the United States.
Among active cases of Kobin 19 infection globally. The number of patients that are seriously are critically hill is currently approximately 48000.
Which represents about 2% of the 2.27 million patients with the confirmed in active infection.
Among the roughly 1.6 million fully resolved cases, where the patient is either successfully recover and orban discharged from the hospital or the patient has died the cumulative mortality rate is approximately 17%.
Both here in the us and internationally regional and national governments have implemented minute have implemented mitigation strategies designed to slow the spread of infection.
These include implementation of shelter in place and work from home policies travel restrictions mandatory closures or significant operational limitations of businesses public facilities schools and other organizations.
This has impacted our lives and the national and global economy in ways that were unimaginable to many people prior to the outbreak.
The mitigation strategies appear to have slowed the spread of the virus and the devastating impact the pandemic.
But this is comment a significant cost to many individuals and families.
It's also clear to everyone that this problem is not going away anytime soon.
Ultimately resolution and containment will rely on the successful development and widespread deployment of fast and accurate diagnostics.
Back to vaccines to protect people against infection.
Anti viral treatments at less than the intensity in severity of cobot 19.
And novel therapies, enabling treatment of patients that do become seriously for critically ill.
Each of these represent a critical line in the defense against the virus.
However, we must remember there's no diagnostic will be 100% accurate no vaccine will provide perfect protection for everyone that received that normal anti viral there are other interventions be effective in every one that is treated.
We understand this from decades of experience with influenza and other offerings, including the Corona viruses that caused Sars and merce.
This experienced teaches us that these will all be important steps in the right direction.
But nothing provides perfect perfect.
And we will need to remain vigilant.
Some patients will still become seriously are critically ill and unfortunately some of that.
Thats, where we believe athersys can make a difference.
Our current focus is on treating patients that have become seriously are critically hill. Following cobot 19 infection and that are experiencing cards and other life threatening complications.
We are informed by our experience from our prior clinical work that provided evidence that administration of Multistem to patients experiencing art within the first few days of being ventilated might meaningfully reduce mortality, especially in more severely ill patients improved pulmonary function and help patients achieved ventilator independence increased mentally.
Later free days I see you free days and achieve better quality of life following discharge from the hospital.
In addition, as we've described previously this exploratory trial fully met the safety and Tolerability endpoints and there were no treatment associated severe adverse events or FCS there were cause we attributed to Multistem. Following administration of the product either during the acute clinical assessment 28 day clinical assessment.
For the one year fall.
As we announced in the last earnings call. We began a dialogue with the biomedical advanced research and development authority or BARDA in late January that was focused on the potential for using multistem as a therapy for patients experiencing ours is a result of covert 19.
As we've described previously pardon leadership recognized and appreciated several key points, including one that there is no effective treatment for arch currently available and that is is the primary cause of mortality among patients suffering from severe pulmonary dysfunction and inflammation.
To that Multistem acts through mechanisms that are not pathogen or virus specific and therefore, it might be broadly relevant in situations, where new viral pathogen outbreaks emerge that caused severe pulmonary inflammation and arts.
And three that in contrast to traditional pharmaceuticals, or biologics that after a single mechanism of action multi stem is a living cell therapy, but has the potential to actor multiple mechanisms of action.
In the days and weeks that followed our initial discussions with BARDA, we were invited to present to the Corona Wash task force provide other information and then ultimately submitted proposal to BARDA that laid out our proposed development path relating key activities and budget.
We remain actively engaged but as this process is ongoing and we are subject to certain restrictions until the process is completed we are unable to provide additional comments are further detail for the time bins.
In parallel our team has worked very hard with our clinical experts and advisors our contract research organization and the FDA to define a pivotal study to evaluate the efficacy and safety of administration of Multistem to treat patients experiencing cobot 19 and do start.
It's important for everyone listening in today to understand just how rapidly things have progressed and how much work has been done.
In the span of only a few weeks we designed the study submitted to the FDA for their review responded to questions comments and request for additional information.
Received FDA authorization for the trial screened initial clinical sites for the study obtained IR be approval successfully launched the trial and enrolled the first patients into the study.
All of this was achieved while a statewide locked down has an effect and during which many of our employees worked remotely.
We overcame enormous obstacles to get this not and I'm immensely proud of the team and individuals that are responsible for making it happen.
It's also important for everyone to recognize that we remain very optimistic regarding the potential contribution we in our technology can make in helping patients during this pandemic.
However, this is an ongoing process and there's a lot of additional work to do.
In the meantime, we've continued to advance other important initiatives as we recently announced we've obtained FDA authorization to initiate our planned clinical trial to treat trauma patients working in collaboration with the University of Texas Health Science Center at Houston, where you see health and Memorial Morial Hermine, Texas met.
Nickel center and with support from the Department of Defense Amtech, and the Memorial Hermann Foundation.
We've also continued to advance our ongoing masters two phase three clinical trial to three patient suffering a debilitating stroke.
Despite the disruptions that have impacted normal operations in clinical trials support had many hospitals that have slowed or even halted many trials.
We have continued to support our partner in Japan Healios as they approach the completion of two important clinical trial. The one bridge study evaluating administration of Multistem for the treatment of art and the treasured trial for the treatment of patients that have experienced meaningful disability from the occurrence of a scheme extra.
Healios has stated publicly that they anticipate completing enrollment for both trials this year.
We also advanced our ongoing discussions with other potential partners regarding working jointly to further advanced the development and commercialization of Multistem in key indications and geographies of interest.
In addition, we also meaningfully strengthened our financial position.
This happened through two key events recently.
The first was the decision by our partner Healios to fully exercised their warrant to purchase an additional 4 million shares of stock, resulting in more than $7 million in proceeds as I've described.
The second was the financing we recently completed that resulted in gross proceeds of $57.6 million.
Upon completion of the financing in April we had approximately $89 million on the balance sheet and we have no debt.
These events put us in a solid and stable financial position with the ability to further advance key programs and initiatives and operate through and beyond important milestones.
In closing Theres no question that this is a challenging an exceedingly difficult operating environment for everyone, including us our collaborators and many of the key serves and riders that we work with and reliable.
The pandemic has had a devastating impact on individuals families businesses and other institutions across the United States in around the world clinically and economically.
But in many ways it reinforces the importance of what we're committed to doing.
Despite all the chaos uncertainty and obstacles our focus in our commitment have never waiver and our belief and the potential of our technology remains as strong as ever.
I think our progress since January shows that we know how to get difficult things done even in a very challenging environment and unusual and chaotic circumstances.
Our commitment to helping patients in areas of substantial unmet medical need and to delivering substantial value to our shareholders remains as strong as ever.
Before I move on to addressing a few questions I'm pleased to introduce a recent addition to our executive team Maya Hanson.
My have joined US in March and for her most recent role as a senior partner at Mckinsey and company.
My brings with her decades of experience in operations strategic planning and commercial supply chain management.
Partnering with other members of the executive team mine will help us continue to establish implement and develop the organizational capabilities athersys needs as we continue to advance towards potential commercialization of the multistem products.
And with that I'd like to have Maya briefly introduce yourself Matt.
Thanks, Gil and good afternoon, everyone.
Gill mentioned I joined Athersys team in mid March of this year as the senior Vice President of operations and supply chain prior to joining Athersys I had the opportunity to get to know members of the company leadership team quite well and develop an understanding of the company vision and long term objective and I'm very excited to now be part of that.
Prior to joining other service I was a senior partner at Mckinsey and company over 22 years Wood Mackenzie.
Worked across several industries with a particular focus on life science companies, including major pharma companies large and small molecule manufacturers and distributors I think you see companies and others I.
I played important leadership roles building Mckenzie is global operations practice, and leading the Cleveland office as managing director.
My background before Mckenzie includes four years, as an officer and the Navy and educational background in engineering and business.
I am excited to join Athersys for several reasons.
Therapies are meaningful to patients and clinicians around the world. The company is that an important point and its growth and the leadership team of talented and focus on building a strong culture and lasting set of capabilities.
My first weeks on the job I have brought my experience with supply chain management sourcing manufacturing and data analytics to support the advancement of successful clinical trials and help prepare us for commercial readiness and subsequent growth.
Overtime I look forward to working with other members of the team and to building a commercial scale end to end supply chain that as high quality efficient and flexible.
Once again I'm delighted to be part of Athersys entity with you on the call today.
Thanks, Mike.
And with that we would like to first address a few questions that were submitted by shareholders before we open it up for questions from analysts and other institutions.
The first set of questions relate to our ongoing discussions with BARDA people have asked whether we are still pursuing BARDA funding what the statuses do we believe that we will be successful in this effort and how long will it take.
I've already addressed most of these in my earlier comments, but just to be clear. We are still actively engaged with BARDA and we remain optimistic but we are unable to provide further comment for now.
The next question relates to recent activity from other companies developing innovative therapies for treating cobot 19, or complications, including those focused on development of anti viral anti inflammatories and even other cell therapy companies.
While we closely monitor a range of other companies and initiatives, including the emergence of new data and results from trials.
We never publicly comment on.
Unlike others, we don't comment on or hype observations from compassionate use administration of potential treatments. Instead, we are committed to conducting properly design double blind randomized placebo controlled trials.
This is the most appropriate and reliable way to effectively evaluate the therapy for potential FDA or other regulatory approval and make it available to all that may need it instead of just a few compassionate use cases.
We believe our technology has unique relevance in potential and addressing patients with Kobin 19, and do starts and potentially other complications as well.
We also believe that we have important advantages and scalability and our ultimate ability to deliver multistem is an off the shelf cell therapy commercially to hospitals and patients around the world.
As we've already described we're committed to conducting proper clinical trials to further evaluate the effectiveness safety and tolerability of Multistem.
And we're the only cell therapy company that has clinical data for the treatment of art from a randomized double blind placebo controlled trial and also the only cell therapy company that has fast track designation from the FDA for treating arts.
The next question has to deal with the eligibility of patients for our ongoing Mcrobie a trial.
People have asked will patients that have received other treatments be eligible for enrollment in our trial.
The patients are enrolled and another clinical study that precludes them from participating in another trial, they will not be eligible for inclusion in our study.
However, patients that have been treated under standard of care or that have received treatments that did not prevent disease progression and these treatments were completed or discontinued including certain treatments that might be administered on a compassionate use basis.
It's a patient is subsequently diagnosed with arts requires ventilation and meets our other inclusion and exclusion criteria they would be eligible to participate.
This reflects our belief that we can play a unique role in treating patients that had become seriously are critically ill from kobin 19 and that require ventilator support.
It also reflects our belief that multi stem may be administered on top of standard of care, which is essential when patients continue to deteriorate and become seriously are critically ill.
Other people have asked about the effective operational disruptions at hospitals participating in our ongoing clinical trials like Masters too.
Specifically, we will these disruptions impact our study timelines.
It's clear that many hospitals have been disrupted by the operational constraints implemented in light of the cobot 19 pandemic.
The FDA is recognized this and they have been very pragmatic about allowing companies in participating study sites to make adjustments in light of the challenging circumstances that hospitals clinical staff patients and companies are operating in.
We remain committed to completing enrollment of our trials as quickly as possible and we expect to complete enrollment of the masters to study sometime next year, but at this point, it's too early to give a precise timeline or estimate.
Strokes first of all happening and sites in our study continue to enroll patients that people should recognize that many clinical sites are limiting clinical trial participation or activity in light of the current restrictions and operational environment and that's understandable.
We can't say when things will return to normal in the hospital environment or elsewhere and accordingly, we're all taking it one step at a time.
With that we'd like to open it up for a few additional questions for future additional questions from analysts and others.
Thank you.
Two.
Good.
One.
Right.
Okay.
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Thanks.
Okay.
Your first question here from Tom Miller.
The sensitivity.
Your line is now open.
Congrats on progresses. So I will have one first couple of follow ups here. So could you provide a little bit more color on the open label safety cohorts slowdown with Ards trial the Nike.
We'll be able trial Mike.
And Dupont assess safety at four and 24 hours post dose as was down in the face who are trying.
Yes, so the two small dosing cohorts that represent the initial part of the study are essentially designed to confirms safety in this distinctive patient population because we've never specific we looked at Tobin 90 patients up to this point and this is something that we've done in numerous clinical trials that we can do.
During that particular window and it's still true to a certain degree there's a lot of market chaos and a lot of uncertainty on the financing fraud.
And I think that the process, even under those chaotic it very challenging circumstances.
<unk>.
Exceedingly smoothly.
Now obviously with all the challenges and the backdrop. We had this offers certain things and be pragmatic and flexible about certain things, but I'm actually pretty satisfied with the transaction that we got done and how the team in the institutions that we work with to get it done all work together to achieve it under some pretty unusual.
You know circumstances.
I don't know if you have anything to add on that front, but.
No.
Sorry.
Yeah.
Oh, okay.
Go ahead.
No I I understand it's very very difficult circumstances, but it seemed like a much more fundamental raise than some of the other race I've seen and so my sense is that there was a true transition occurring in the retentive medicine space, maybe maybe cove. It is accelerating things in many industries in many.
Sectors from working at home and maybe two regenerative medicine, and so you know maybe the raises a little bit of a litmus test that we're seeing that transition and I guess good <unk>. Thank you sorry.
No I think I think you're right about that I I think there is an important inflection.
And I think it relates to what we're doing specifically <unk>, but I do think it applies a little bit more broadly than that now also point out that that there are probably there's some companies that are getting left in the wake up that I mean, there's a lot of really difficult circumstances, I know quite a few companies out there that would like to be able to raise capital and just aren't going to be able to do it anytime soon.
I think one of the nice things about the situation that upon the completion of the rays and the other things that we've been able to do is first off from an operational perspective, we're in a stronger position than we've ever been in both from a leadership team and throughout the organization in terms of the capabilities in a talent and we had in the commitment is strong.
<unk> work certainly as strong as it's ever been but I I think people just tremendously excited about what we can do from a financial position. We have the resources now be able to do some of the things that we have to hold back on and in fact, we we got quite a few questions from people said why would you raise money now you know why why well the the short answer is that it was important for us to do that to that.
Could move more efficiently and get some of the really important things done while we're continuing to have discussions with others about how they can tangibly support and accelerate our efforts in areas that are really important other institutions or or partners. There were engaged in discussions with we didn't want to have to wait for all of that and let the clock basically be working against us.
Yeah, a lot I had your your ability to partner with with you know a year to two years worth of capital runway changes the terms very dramatically and we'd all much rather see you know and aggressive partnership that gives you the things you want to assure market penetration.
And and do that from a position to strengthen weakness so I I think that makes.
Total sense I also think.
<unk>, it's interesting to me because I look at what's happening in return of Medicine, and Arts and I see a very sharp increase in valuation among all the players I think the rates may pick up to you, but that's very very temporary and that's why it becomes so critically important to see what the fact is here among the.
These patients and of course, you know I'm a believer, but I also see you know different sets of comb morbidities that bring patients yep into a position where they're on a ventilator and so can you talk a little bit about you know I have a patient they're on a ventilator, they're going through a cytokine storm.
We're getting flooded in their lungs, if I smash them with steroids I can you know reduced the inflammation, but I'm not clearing the virus. So yeah why is multi stan different versus <unk> in my tool belt in Mechanistically to address.
Typically the inflammatory response than the lungs that are killing these patients, but without interfering with viral clearance.
Yeah, It's it's a great question so.
And there's kind of multiple layers to the answer a few well but <unk>.
<unk>.
The administration steroids or other kind of one instruments immunosuppressants have not worked in in fact in some cases are making things meaningfully worse one of the things that we know about multi seven is that these cells, they're not just.
Dialing down the hyper inflammatory cascade, which is a bit on overload in these patients that's what what's what's causing the complexity and the severe dysfunction in their lungs, but these cells are also stimulating other key mechanisms that are repetitive nature. So we know that be self stimulating.
<unk> macrophages for example, or other cell types that help clean up the damage restore structural integrity to the tissues, it's been compromised and restore balance to the immune system. So it's so it's dialing down the things that are really bad and dialing up the things that we need more up earlier in the disease process that otherwise wouldn't happen on their own and.
That makes it fundamentally different from traditional pharmaceuticals, or you know you mentioned quarter of steroids or other things that people would be.
Had looked at and and so I think that what we've realized is a couple of important things.
One of the blunt instrument type approaches really are not effective and and they can't as I said that can be counterproductive and even harmful in some cases, but the other thing that's really interesting is there's more and more evidence about oh a range of different types of complications that are being caused by the virus. In fact, there was really good article today in Wall Street Journal of.
Talked about this at length and pointed to the impact on not only on the parliamentary system, which is clearly driving a lot of the downstream cascade of things, but some of the other things that are happening. So for example, we see alberich body activity in these patients leading to strokes or <unk>.
And other things that are going on in the interesting thing is that with multi them. We have meaningful evidence that shows that these cells can actually restore balance where it's needed in a multi dimensional way. It's not just doing one specific thing and then that's it away traditional pharmaceutical or for example, I'm not trying to pick on <unk>.
Say aside and inhibitor riled six inhibitor or something like that would be those things may help, but they're not going to provide ineffective comprehensive solution and I think the thing that makes cell therapy, and I know I'm preaching to the fire here because you've written about this for years and you pointed to this day the multi dimensional effective cell therapies is distinctive and critically important.
Particularly in these types of critical care situations, where you need help fast and where you want to do more than just one specific thing.
So we have a lot of evidence and a lot of clinical data and a lotta mechanistic support including biomarker data that shows that we administer multistem, they're achieving all of those things and that's one of the reasons why we are so confident and we were so optimistic about the position that were in and and you know frankly, where we think we're going to be and they're not terribly far our future.
But you know you asked earlier part of the initial.
Question number two that you asked was about you know what's going on in Japan, and what's going on here on what's happening globally.
So obviously this is this is something that's become another focal point for our partnership with Healios, They announce not too long ago that they're planning on running a a kind of a mini cobalt. If you will a few patients looking at Kobe 19 to do starts along side. The one bridge study that they're actively working towards completing.
And I think that they recognize may appreciate add to the clinical experts at their working within Japan, Although it's not as big a problem in Japan as it is in other parts of the world and that's because of the culture and some of the practices over there that it maybe been natural factors mitigating the spread of the virus or <unk> or mitigating some of the.
Things that have gone on <unk>, but but nonetheless, it's a problem everywhere and I do think that that there's a general recognition.
That can I know the regulators are are certainly interested in that because they just announced today that I think they're providing expedited emergency approval of <unk> four as a treatment option to try and you know get that out there. So they can have an impact. These are all appropriate and I think encouraging steps at the regulators are taking because it it both.
Well for companies like us because we generate more data.
And are able to really continue to strengthen our position frankly, I think they're looking for things that can really have an impact on the critics <unk>. The critically ill side of things in particular and I think we've already shown that's where we can have an impact.
So we're you're you're you're 100% right, except that things are much worse than Japan than what the U.S. media reports you know that I'm very dolled in there and we watched the Japanese media. So the opportunity to you know treat patients <unk>.
Yeah.
Who who are on ventilators in Japan is it's a huge opportunity and I'm sure that the Japanese are very interested so you know back yet surprise and I think one of the other things you said that was so important was that clinical time lines, you know I have not been decimated and.
I know that Healios had been talking about you know hopes this year for both treasure and one bridge and and I think it's more than reasonable to say you know, you'll reevaluate masters, but there's still hope here for for data next year, so and by the way that to me makes the stock more attractive because we get to C.D.
Outcome on Cove at 19, potentially before we do want stroke and I think that becomes transform it is so with that coupled with cash in the management team I'm. So excited. Thank you very much really look forward to you know continuing to a watch the company evolve ride spent a long road for all of us and so.
Yeah, I'm, so glad that you're there and you're driving it.
Yeah, well. Thank you, Jason we really appreciate the support.
Thank you.
Yeah. My question comes from the line on problem.
See how Carolina.
Great. Thanks, Good evening, and and let me add my my congratulations to just the unprecedented pace progress.
I guess it matches with the unprecedented times.
If you could maybe you're out there on them.
Line with you know regulators and.
<unk> government and and.
Local community, maybe talk a little bit about what you're seeing about sort of the ecosystem of of Kobe drug development out there I mean, there's there's a lot of unprecedented things happening and sort of the normal way of thinking about getting things done has been you know sort of.
Run out the window.
Yep.
Yeah, well I think for regulatory perspective, I I can say that the F.D.A.F. <unk>. The F.D.A. in particular has been.
Incredibly engaged and remarkably responsive they as much as anybody understand the need for speed.
So to speak.
And I mean, we were as we were working together to finalize the protocol.
We we were going back and forth, sometimes several times a day with the F.D.A. either covering on specific points answering questions or or asking questions and getting and and getting very responsive feedback from now so.
I I just want to take one more opportunity to thank the F.D.A. team. They read it quite a lot of effort internally to to try and help expedite things now I know some people are a little bit frustrated by that because as the F.D.A. just as hospitals and other institutions redeployed a lot of their internal personnel and resources to focus on.
Yeah.
The the way that was occurring.
It did come as something of an operational costs on other fronts, but.
But I think we're sensing now that at least some of that is now heading back in the in the other direction.
And I think people feel like okay. It's it's been very challenging are obviously a lot of patients in the hospital a lot of patients have gotten really sick a lot of patients got seriously or critically ill.
But I think that the mitigation strategies of definitely had a positive impact some of the hospitals are beginning to kind of redeploy people back to where they were where they need them to be on other fronts and I personally see that as a real positive.
So in terms of the broader landscape.
Yeah, we've all had to make adjustments and you're absolutely right that I mean, if you think about where we were just a little over three months ago.
<unk> anybody was thinking about the things that were all now talking about and living with every single day.
The fact that we've been able to move so quickly and just get so much stuff done is a testament too I think the broader ecosystems willingness to work together get things done that are critically important now I will say on some of the clinical trial activity. There's a fair amount of noise out there. There's some things that are out there that frankly don't really make any sense don't really have a strong basis.
<unk>.
For putting resources into it or or for putting a lot of muscle into those things.
That is driven I think in some degree by this year desperation and a lotta people have been experiencing as loved ones are family members where people they know.
Become really sick and they've had to do things.
But I expect that what's gonna happen over the next several months and even out further beyond that.
Is that we're going to start to see some clarity.
From the things that have the strongest evidence based the things that are the most rational and well founded those are the things that are really going to rise to the top some other things that we were hearing about just a few weeks ago that people were pointing to based on anecdotal evidence or things that at first might sound kinda promising the Evan.
It's at the end of the day when that argument, sometimes those things might actually stand up and sometimes they don't but the point is is that.
<unk>, they're not going to waste time with the things that don't make sense.
They're they're going to emphasize the things that they see real promising real potential for and that's where I think we come out ahead.
It's not going to happen instantaneously, but I'm confident that's where we end up.
Yeah, and I mean.
<unk> conditions that got us here or or or and also more but there are some some amazing thing going on there and that I find very encouraging you guys are are definitely part of that so.
You make your friendship yesterday.
Excellent. Thank shad really appreciate the support.
Yeah.
<unk>.
And that now I'd like.
<unk>.
Thanks, Casey was always I'd like to thank everyone for taking the time to listen into the call today and for your continued support we remains fully committed to advancing our programs in achieving our goals and we look forward to making additional announcements and providing updates as we move forward from here.
[noise] Cool Cool conference call. Thank you.
<unk>.
[music].
Yeah.
[music].
[laughter].
[laughter].