Q2 2023 Amylyx Pharmaceuticals Inc Earnings Call
Good afternoon. My name is Tom and I will be your conference operator today at this time I would like to welcome everyone to the Amalek Pharmaceuticals second quarter 2023 earnings conference call.
All participants will be in a listen only mode. After today's presentation, there will be an opportunity to ask questions.
Ask a question. Please press Star then one on your telephone keypad to withdraw yourself from the question queue. Please press Star then two.
Please be advised that this call is being recorded at the company's request I would now like to turn the conference over to Lindsey Allen head of Investor Relations and Communications. Please go ahead.
Good afternoon, and thank you for joining us today to discuss our second quarter 2023 earnings with me on the call are Josh Cohen and Justin We are co Ceos, Margaret Olinger, our Chief commercial officer, and Jamie Friday, Our Chief Financial Officer before we begin I would.
Like to remind everyone that any statements. We make are information presented on this call that are not historical facts are forward looking statements that are made based on our current beliefs plans and expectations and are made pursuant to the safe Harbor provisions of the private Securities Litigation Reform Act of 1990.
Got it.
The statements include but are not limited to our expectations with respect to Rev Library of algorithms that statements regarding our clinical trials and regulatory developments and the expected timing thereof.
Our business strategy and outlook and our expected financial performance.
Actual events and results could differ materially from those expressed or implied by any forward looking statements as a result of various risks uncertainties and other factors, including those set forth in our most recent filings with the SEC and any other future filings that we may make with the SEC.
You are cautioned not to place any undue reliance on these forward looking statements and analytics disclaims any obligations to update such statements unless required by law.
Now I will turn the call over to Justin.
Thank you Lindsay and good afternoon.
In the second quarter, we made significant progress in bringing real embryo and Albert he owes it to people with ALS and the U S and Canada, respectively and.
And advancing our mission of one day ending the suffering caused by a L S and other neurodegenerative diseases.
We are incredibly proud of our entire team who has continued to deliver on the goals that we outlined following the full FDA approval of delivery out last September .
These goals included raising awareness and educating people living with al asked with it and physicians about delivery out working with insurers to provide access to our approved treatment, helping people who had been prescribed delivery else through our analytics care team patient support program and deepening our understanding of the AOS market.
Let me walk you through our progress.
Our commercial organization is off to a strong start educating and raising awareness about delivery.
As evidenced by the strong and steady demand we saw in the second quarter.
As of June 32023, there were roughly 3800 people unwilling REO in the U S up from roughly 3000 people Unrelenting me all as of March 31, 2023, and just over <unk> hundred at the end of 2020 two.
As for an insurance coverage adoption has been rapid.
And a vast majority of policies have been broad and supported it.
Insurers covering nearly all people living with al asset published formal policies and recovering reliv real.
And people living with ALS that had been prescribed <unk> are now able to start therapy more quickly.
The average time between a prescription being written and delivery are being shipped was about 25 days in the second quarter down from around 30 days in the first quarter of this year and a little over 45 days when we shared this metric on our fourth quarter earnings call.
Turning to Canada, we reached our one year anniversary of the health, Canada approval with conditions in June .
As we reflect on our progress we are pleased with what we have achieved on behalf of the Canadian AOS community.
In the fourth quarter of last year, we announced that all major private insurers in Canada covered out Rosa and we were pleased to share today that by the end of August we expect already over I'll Brio is a coverage to be in place for the vast majority of publicly insured lives in Canada.
The early success of our commercial launches has enabled us to both invest in bringing delivery out to more people living with ALS globally and advance our pipeline opportunities that support our mission.
We continue to expect a final opinion on our MAA from C. H M T in the fall and prepared to execute a successful launch in the EU if approved.
We are excited to initiate our new phase III Orion clinical trial of an extra 35 in progressive Supranuclear palsy later this year.
And of course, we continue to work diligently to complete the Phoenix trial with top line results anticipated in mid 2024.
In summary, we are proud of our progress so far in 2023 and excited about what we can achieve as an organization.
We have a clear mission and we are executing on our goals.
Now I'll turn the call over to Margaret to provide an update on our commercial performance.
Thank you Justin.
In the second quarter, we continued to make significant progress on our three key priorities.
First is our efforts to drive awareness and educate about the benefits of our liberal among people living with ALS and clinicians.
This includes educating that really is the first and only approved drug for adults with AOR to.
Australia statistically significant benefit in function in a clinical trial as well as the survival benefit and a longer term post hoc analysis.
As a reminder, clinical trial data published in the New England Journal of Medicine demonstrated that after 24 weeks.
So penetrated with roller real scored on average 2.32 points are on the AOS FRS scale than the placebo group.
Even a one point change in the E. L F F or S score can indicate a significant different in a person's ability to function independently with activities of daily living including eating bathing dressing or walking.
Participants treated with Liberty out at the start of the clinical trial, which means that they both started really a real six months earlier and were on it for a longer than participants starting on placebo.
Greater survival benefit.
During the second quarter interest in and demand for delivery or continue to build at a steady pace from both those that are newly diagnosed and people who have been living with ALS for years.
As a result of our educational efforts as of June 30th they were roughly 3800 people on delivery in the United States.
We are very pleased that so many people have gained access to this important new treatment so quickly.
Yeah.
Let me run through a few key metrics that demonstrate our progress and growth opportunities ahead of us.
Prescribing remains fairly concentrated with just over 80 prescribers, mostly at major a lot centers, representing approximately half of all where Libya prescriptions at the end of the quarter.
We are encouraged by the level of interest among this group and believe that we have an opportunity for growth as we bring our message to more prescribers and deepen our relationships within these T. A L S centers.
By the end of the second quarter, approximately 75% of the top 500 U S prescribers and nearly all of the key E. L. F centers had prescribed <unk> to at least one person since launch.
We are focused on driving awareness and education and on deepening our penetration within the top prescribers N T E. L F centers.
In addition, we have a large untapped opportunity for growth outside of this group of top prescribers as we expand our outreach and educational efforts more broadly.
Our second priority is engaging with payers to work to help ensure that every eligible person who could benefit from where liberty O treatment has access as quickly and efficiently as possible.
Consistent with the targets, we previously outlined.
At the end of the second quarter, our estimates suggest that U S insurers, representing nearly all ALS covered lives had published formal coverage policies.
The vast majority of these insurers provide broad access to relive Rio.
This is a significant accomplishment just three quarters into our commercial launch.
Our third priority is ensuring eligible people living with a laugh had positive interactions with their treatment journey with rollover out and a L. S clinics have positive interactions with amex.
This includes facilitating in Oregon is clear process to get people, who have been prescribed where liberal access to therapy as quickly as possible and optimizing people's experience, obtaining where liberal as best we can.
Our team has done a tremendous job of facilitating the process increasing the speed between the prescription being written and delivery of being shipped.
In the second quarter on average this timeline was shortened to about 25 days.
Aided by the increase in insurance coverage.
Our team continues to work expeditiously to get people living with ALS, who had been prescribed where liberal on therapy as quickly as possible.
Turning to our launch in Canada.
Interest in our browser remains high.
We have made significant progress on our public insurance coverage efforts. We are thrilled that's five Canadian provinces, Ontario, Quebec, British Columbia, New Brunswick, and most recently, Alberta announced public reimbursement of al browser.
By the end of August we expect Alberto's of coverage to be in place for the vast majority of publicly insured lives in Canada.
Our goal is to ultimately change the way people living with ALS are treated and we believe were liberty always becoming a foundational therapy for a L. S.
As we move into the third quarter our team remains focused.
<unk> focused on driving awareness and education about where liberal among people living with E L F and clinicians.
I will now turn the call over to Jim to discuss our financial results for the second quarter.
Thanks Margaret.
We're encouraged by the strong interest in demand, we continued to see from the analyst community in the second quarter.
From a financial point of view our business remains strong.
Net product revenues were $98 $2 million for the quarter compared to net product revenue of $71 $4 million for the first quarter of 2023.
The vast majority of that revenue coming from the United States.
Gross to net adjustments were approximately 10% in the quarter, which was a little lower than that would we would normally anticipate due to the favorable true up of reserve estimates in the second quarter based on our actual experience in the past nine months.
Going forward, we anticipate gross to net discounts will be in the 12% to 15% range.
Inventory levels at quarter end were as expected with approximately two weeks of inventory in the channel. It's specialty pharmacies similar to what we've seen in previous quarters.
Cost of sales were $5 $6 million for the quarter, roughly 6% of net product revenues and our expectation is the Cogs will remain in the range of 6% to 10% of sales going forward.
Note that we fully expense all of our remaining royalty obligations this quarter and will not be incurring any additional royalty expenses related to sales and a L. S going forward.
For modeling purposes keep in mind that roughly 10% of the people Unrwa livio are receiving it for free through either our interim access program, where patient assistance program.
Research and development expenses were $29 million for the quarter.
If you would expect R&D expenses to be in the $30 million to $40 million range per quarter for the remainder of the year.
As we outlined on our Q1 call our expectation is that R&D expenses will move toward the higher end of this range. Later this year as we start enrolling patients in our new phase III trial N P. S P.
Selling general and administrative expenses or SG&A were $43 $4 million for the quarter.
In line with the $45 million per quarter run rate that we mentioned on our first quarter call.
We continue to expect SG&A expenses in this range for the remainder of the year.
These results led to an excellent bottom line, we generated $22 $1 million and net income representing our second quarter in a row of profitability.
Finally, we ended the quarter with cash and short term investments of $357 $3 million and zero debt.
We're pleased with our strong financial results and with the disciplined execution throughout the organization.
From a capital perspective, we have the resources, we need to execute on our mission.
We're well positioned to grow our topline invest in our pipeline to provide more much needed treatments for neurodegenerative diseases and deliver on our bottom line.
I'll now turn the call over to Josh to discuss our R&D programs. Thanks, Jim.
We have demonstrated the benefit of Amex 35, and hail loss and believe it could help in other neurodegenerative diseases.
When we originally developed Amex 35, our goal was to target endoplasmic reticulum stress for ER stress and mitochondrial dysfunction.
Two connected central pathways that lead to neuro degeneration.
As we announced on our last call, we intend to initiate a global pivotal phase III study in P. S. T. Later this year called right.
Ion is a well powered study that will enroll approximately 600 participants and it was designed and planned in collaboration with key global academic leaders people living with PSP and advocacy groups.
Yes, P is a rare, but recognizable progressive and fatal neurodegenerative disease with clear and well known clinical hallmarks that include progressive disability with respect to eye movement walking imbalance speech and swallowing and cognitive function.
There are currently no disease modifying treatments for P. S P.
And we are hopeful the amex 35 might be able to help.
PSP is characterized as a tell opposite with genetic and pathological findings supporting a primary role for Tau in this disease.
Given the Amex 30, fives proposed mechanism of action that targets pathways upstream of Tau aggregation and the phase two placebo controlled Pegasus clinical trial data, which demonstrated that amex thirty-five significantly lowered both fosler, Taiwan 81, and total tau in the cerebrospinal fluid.
People with all timers disease, we are excited to pursue this indication N P. S P.
We recently hosted a webcast with professor Doctor Gunther Hog linger, a leading expert in PSP and the primary investigator for our phase III Orion trial.
As part of the webcast, we shared insights into the scientific rationale for studying Amex 35 N. P. S P and an overview of the phase III trial design.
Additionally, Doctor hug linger provide his perspectives on the PSP treatment landscape the role of Tau in this disease and the potential to use amex 35 in people living with PSP should it be approved.
The replay is available on the events section of our IR website, and we encourage you to listen to it if you didn't have a chance to join us for the life of that.
In addition to this exciting study N P. S. P. We're also pursuing a program and another rare disease Wolfram syndrome called Helios Wolfram syndrome is a rare disease that leads to multi system failure, resulting in blindness deafness diabetes ataxia nerve degeneration.
Often deaths and early adulthood.
Our R&D team conducted roughly four years of in vitro and in vivo studies of Amex 35, and Wolfram syndrome, together with a leading researcher Dr. For me he koyama at Washington University.
These studies are promising results some of which were published in the journal of clinical investigation insight.
Several papers characterize the disease is a prototypical disease of ER stress and as we have discussed in the past. We believe this study which is currently enrolling participants will provide key data to guide future studies and we expect topline results next year.
We also continue to broaden our AOS and Neurodegenerative disease pipeline.
We believe that in order to ultimately find a cure for AOS, it's going to take a combination approach targeting multiple cellular pathways implicated in disease pathogenesis.
We continue to progress Amex, one 2014.
Antisense oligonucleotide targeting Tau pain to do R&D, enabling studies.
We have presented data on this candidate at the meals MDA and Todd's conferences, we're excited to present more data on the Amex, one 2014 and other advancements in our pipeline in the future.
In closing we are proud of our team's progress in the work that we're doing on behalf of the ALS community.
We're in a very strong financial position, which allows us to continue to support our launches in a loss and invest in our pipeline to find new treatment options for people living with AOS and other relentlessly progressive neurodegenerative diseases.
Now we'd be happy to take your questions. Operator, please open the call up to Q&A.
We will now begin the question and answer session to ask a question. Please press Star then one on your telephone keypad to withdraw your question. Please press Star then two we ask that you. Please limit yourself to one question and one follow up and if you have additional.
Questions you may rejoin the question queue, we will pause momentarily to assemble our roster.
Yeah.
And the first question comes from Corrine Jenkins with Goldman Sachs. Please go ahead.
Good afternoon, everyone. Maybe just first what are you seeing with respect to compliance and discontinuation rate.
Just go ahead with my follow up here are you seeing any emerging trends with respect to the primary reasons for discontinuation it would be helpful, but even try there.
No. Thanks very much for the question, maybe just to start as a reminder, we report on net patients on therapy. So this is inclusive of any discontinuation.
We're really pleased with our ability to serve the roughly 3800 in that patients don't really every hour at the end of Q2.
I would say, it's really too early.
Do you see any long term trends at this point is our launch.
But maybe a reference point in the Centaur trial, which again as a reminder was a six month trial approximately 70% of participants remained on drug and we're tracking close to that in terms of the commercial setting, but I would say this is clearly an area, where we're going to continue to keep a very close eye on you know as we expect the pace.
Sure.
Our mix to shift overtime.
And maybe I'll just start and unemployment reason yeah.
Yeah sure on the compliance side.
The reasons.
So on the client side we've.
We've seen most most rare disease drugs, you'll find in the 75% to 80% range in terms of drug compliance where in that range as well.
And in terms of reasons for discontinuation.
They're varied people with AOS are going through many different many different things.
Of course, the one one of the more common ones, certainly as death and disease progression, which which is expected.
As well.
Okay.
The next question comes from Geoff Meacham with Bank of America. Please go ahead.
Hey, guys. Thanks for the question and congrats on the quarter I had a couple the first is the.
U S C. H M. P process wanted to ask you know kind of how you guys view that process now and and maybe just help us with kind of how you view. The next steps here I wasn't sure.
For Reexamination, you know what the what the protocol or the success rate it could be there and the second question is just related to you know our capital deployment I know you guys have done some deals some BD, but wanted to ask you know maybe how that's evolved over time as you look to be sustainably profitable. Thank you very much.
Sure so on the EU and see HMP, so as we've shared previously.
The EU adopted initially in a negative opinion.
We strongly disagree with that without opinion and I think the basis for that is we ran a randomized placebo controlled study met our pre specified primary outcome showing a slowing in the rate of progression on the AOS. After a song we've also observed a difference on overall survival.
David of course led to our approval, but they were full U S FDA approval and our approval with conditions and health, Canada. So we believe we have a data package that should in.
In our view support support approval, but of course ultimately this is up to two cgmp. So we submitted for examination, that's roughly a four months process under which to new rapid tours are assigned and review the application.
Did that shortly after we got the we got the negative opinion. So you can expect that near the end of this year well hear back regarding that opinion.
In terms of capital deployment and potential B D I'll talk to I'll pass to Jim Yes.
Thanks, Jeff.
And clearly the profitability. This early on in our launch is very gratifying I mean, I think that ultimately this is a direct result of the need in this patient in this area and divest.
No the dearth of options that people living with Atlas has had so far so we're very proud to be filling some of that need you know I think the other thing I would say too is where we're really focused on what we have on our plate now right with with obviously still in the middle of the launch in the United States and Canada, working through what's going to happen in Europe , and potentially hopefully looking forward to a launch next year.
You know we've started off and are interacting with the Japanese and other places around the world to see where we can continue to take this drug with our PSP program in our Wolfcamp program ongoing.
We're doing you know I'd say the watchword around here right now is focus.
Now longer term I think we have the opportunity with our launch and with the you know the business that we're in.
To potentially do some business development over the longer term, but I think that.
Hopefully, we'll be able to grow the top line grow our bottom line and then also invest in our robust pipeline, but we have a pretty high.
Standard here for new programs and as I said I think right now the watchword is on focus.
Okay. Thanks, guys.
You bet.
And the next question comes from Michael D. Fiori with Evercore. Please go ahead.
Hi, guys congrats on the quarter and thanks, so much for taking my question two for me now with the passage of more time do you have any better sense of the size of the patient bolus at this point.
And my follow up is this I want to push you a little bit on the discontinuation rates I mean, among the early patients chassis receive commercial drug.
And for Q of last year.
Presumably some of these patients are or would have been on drug for at least six months now would you be able to provide any color as to what percent of them are still on therapy. At this point again, just among the patients who started in <unk>.
Yeah.
Yeah, maybe I'll just start with your question regarding the bolus you know we continue to be pleased that the interest in and demand for Liberty. All continues to be at a very strong pace and I think importantly includes a mix of both newly diagnosed patients and paperwork with people who have been diagnosed.
And living where they last for many years.
You know again at the end of Q2, we had roughly 3800 net patients on therapy up from roughly 3000 patients in Q1 and just over 1300 in Q4. So we really believe that at this point in time or Liberty is really starting to become a foundational therapy in E. L F and meeting a really high unmet need.
Need for this patient community, which is obviously our mission and what we've been focused on for some time as far as the growth opportunities, which is equally important to us we see several different opportunities ahead of US are first the prescribing remains fairly concentrated with the 80 prescribers both we at the major Aon Center.
Where our focus was at the beginning of launch representing about half of all of our Libya prescriptions. This quarter. We're also encouraged that the level of interest among this group and believe that we have a large opportunity for growth ahead of us as we bring our messaging to more prescribers and deepen our relationships within those key centers and I think importantly.
Jean Louis prescribers being much more prolific in their prescribing, which I think is an important part and second we have a really large untapped opportunity for growth outside of this group as I mentioned, we were heavily focused on the key E. L. F centers at launch, we're continuing to expand our outreach and educational efforts more broadly.
Because we believe it's critically important that you know everybody is aware of that well. It really is the first and only product that has both function and survival demonstrated in our clinical trial and we believe we can change the paradigm for treatment moving forward.
And maybe just to answer your second question on discontinuation.
You know again, we're only going to be reporting on net patient numbers for a quarter, but indeed I think it's important to reflect that the first cohort of patients who started on therapy at launch.
Many of those who have been really fairly progressed early on so I think we're going to see the dynamic of the patients change over time, so it's a little too early.
To really give any trends.
Trends there.
One thing I'll remind that I think Margaret shared earlier as well.
We in.
In summary, the Centaur study approximately 70% of people completed that study on study drug and what we're seeing in the real world.
It's not it's not so different from that.
But the grand Thanks, so much.
Of course.
The next question comes from Marc Goodman with Leerink Partners. Please go ahead.
Yes, Hi, first question is are you willing to make any comments about what kind of trends you're seeing you saw in July .
And then secondly can you just confirm are you mentioned, 10% of the patients are getting free drug just to be clear that 10% is in.
The numbers that you provide right in the 38 patients that you were talking about.
And it's all included in your gross to net calculation that everything is going to be clear that thanks.
Yeah, Hey, Mark.
Yeah, the 10% of the patients that are receiving free drug is included so those 10% are included in our net patients those are all the patients on therapy at the end of June .
And you know yeah free drug would be included in gross to nets.
Well excuse me free drug is actually in Cogs, right, you're giving the drug and you're not getting any.
Any sales for it so the free drug goes in Cogs any patient assistance that we pay in terms of co pay assistance or things like that that's what goes in the gross to nets just to be clear on that.
And then finally in terms of you know July I think we will comment on the July trends when we report our quarterly results for Q3.
But you know I think our business as you know with now three quarters under our belt, we're all starting to get a chance to see what our business is like moving forward, but but we won't be giving specifics on July at this stage.
Okay. Thanks.
You bet.
Yeah.
The next question comes from Greg <unk> with Mizuho. Please go ahead.
Okay. Thanks, so much congrats on the quarter just two questions. One maybe another way to ask a question that people seem to be trying to get at them do you have any color on or can you provide any color on kind of new prescription trends versus refill trends any kind of metrics you can provide there.
And how that's evolved and then my follow up is I'm I'm curious about the expansion efforts.
Efforts to go beyond the AOS centers, and if you could perhaps put into context.
You know the the portion of a L S prescribers that you're targeting.
Or that you hope to get that are outside of the Aon Center.
Setting thanks.
Yeah.
Yeah, So maybe I'll start and then and then have Margaret join in too. So so again you know we're three quarters into launch we have roughly 3800 net people on treatment.
As at the end of Q2, which you know we're we're very pleased about it I mean.
That's 3800 people with AOS for helping but that means that there's many many more people that we'd like to help as well.
But.
I think we all hear constantly reminded of the the mission at hand and you.
You know I think the.
ALS market and in many ways is a is a unique and it's because it's a large rare disease, there's a huge unmet medical need.
And historically there have been a few treatment options and so I think the way that we've thought about our business is Margaret was sharing is to focus on the AOS specialist.
And then continuing to look to broaden out and so I think as we look at our prescription numbers, where our people have focused a is where we're seeing the prescriptions as well and then Margaret I'll invite you to start sharing more details on that.
Yeah, so as we've indicated.
Heavily focused at launch, which I think was the right strategic decision to focus on the key a L. S centers, where the majority of the ALS patients are actually treated. However, there's also a number of a lot of patients that are treated outside is that a L. S centers, where multiple reasons either they they can't transport they they can't get there at a reasonable time.
You know and it's you know they typically need to go there every quarter to see the multidisciplinary care. There are a number of general community neurologists that are equally important to be educated and that's why we're expanding our focus and we are continuing to increase our penetration and reach out to those yeah, what we call our.
Tier a tier b targets.
And we're just going to continue to work on that expansion moving forward because it's really important for us that you know every physician, who treats and I L. S. Patient is educated about the significant really real benefits that we can bring to be able to serve the patient community optimally.
Again, if you'd like to ask a question. Please press Star then one to join the queue.
And the next question comes from Amanda Gosh with H C. Wainwright. Please go ahead.
Oh, Hey, guys.
Thanks for giving me time, Oh, so congrats on the quarter.
I have two questions on the Atlas program and one for the PST a the first question is basically somewhat while the question with keeps coming from the investment community and that would be you know, it's Phoenix as a required a confirmatory study for accelerated approval of fairly variable and what if it <unk> then can you initiate that process.
Pollute off from the market. So any clarification on that would be great and then I have a follow up question on the Atlas program and then obviously.
Sure and thank you for the question Ananda and Yeah, I mean, you know first.
There's a full FDA approval, there's there's no condition of the Phoenix study.
In Canada, it's in N O C C, which means they're noticing compliance with conditions.
And again, our expectation in Europe , if if there's an approval if that it would also be a conditional marketing authorization and the condition there would be Phoenix.
So we continue to run the Phoenix study, we'll have those results mid next year.
That's a very highly powered study and we and I think the L. S. Community are looking forward to those results are but from an FDA perspective, it's a full FDA approval.
Great. Thank you.
The next question is if you look at the last quarter, you had remarked that the patient that might Oh, you're going to show signs of stability.
Stability is it is it still or is that is that segment still agreements valued for as we think ahead in terms of the growth.
We've got really feel.
Oh, well. So you know I think the question Youre, bringing up on an Ah patient responses is is a is a critical one in neurodegenerative disease, and it's a new it's a new area for all of US and I think it's really really exciting, but I'd say, it's still too early.
To really tell right now and in the AR in the Centaur study, we certainly we saw some people who seem.
Seem to progress very little and others, who are who progressed faster, but whether that was due to there are specifics, whether it's genetics or environmental or whether that was just due to their course of disease are those are the questions that we're still asking and we haven't been able to ask because we haven't had effective.
<unk>, but I'd say you know at this time, it's just too early to know, but certainly those sorts of real world evidence type approaches.
Thing that we're very very excited to do more of it because I think you can start to ask some really really critical questions. When you have an effective treatment.
Corey.
Thanks, and my last question was on U S B O b.
Just on some natural history data, so we kind of for that the POC studies in general has a couple of these advantages one is a very high rate of dropouts and even some of the scale to assess cognition in depression, mostly field. So at least in the historical PSB trials. So what has been your thought on it and how.
How have you kind of incorporated these these into into your phase III trial design.
Yeah, So we shared and probably even more importantly, professor Dr. Gunther hug linger.
Shared on a recent call that we did that's that's published on our website.
You know are much more in depth view of PSP and or in our upcoming clinical trial.
So in our PSP trial, we are designing the study based on the P. S. P. R. S. The PSP rating scale. This is a scale that tracks on primarily I would say, primarily kind of motor and functional rather than a cognizant of.
Outcomes of PSP.
The PSP rating scale and studied in several past trials on what's been found them quite consistently there's an approximate 10 point progression over over approximately a year.
It's a pretty small arrow bar in a pretty pretty tight.
Yeah kind of variance when you are when you run. These studies mm drop out is not in our view and has not been in previous studies beyond what you might have in other neurodegenerative diseases and again as it has been shown from the previous studies on this is this is a space actually where the power is quite good compared.
To most neurodegenerative diseases, so I'd say overall and again I encourage people to listen to the to the webinar, where we go into this in a lot more detail, but I'd say overall, we feel very strongly that.
Know that we have a great trial design, we have a great scientific rationale and this is a great indication to take Amex 35 into.
Great. Thanks very much.
This will conclude our question and answer session I'll turn the conference back over to Justin <unk> for any closing remarks.
Well. Thank you operator, and thank you all for joining us on the call today and for your support. So we hope you all have a good evening thanks for joining us.
The conference has now concluded. Thank you for attending today's presentation you may now disconnect.