Q1 2024 Fulcrum Therapeutics Inc Earnings Call
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Yes.
Yeah.
Good morning, and welcome to the Fulcrum Therapeutics first quarter 2024 financial results and business update conference call.
Currently all participants are in a listen only mode.
This call is being webcast live and can be accessed on the investors section of full com's website at www Dot fulcrum, TX dot com and is being recorded.
Be reminded that remarks made during this call may contain forward looking statements within the meaning of the private Securities Litigation Reform Act of 1995.
These may include statements about the company's future expectations and plans clinical development timelines and financial projections.
While these forward looking statements represent forecast to us as of today, they should not be relied upon as representing the company's views in the future.
For a may update these statements in the future, but it's not taking on an obligation to do so.
Please refer to forecast most recent filings with the Securities and Exchange Commission for a discussion of certain risks and uncertainties associated with the company's business.
Leading the call today will be Alex Sapir, CEO and president of Fulcrum, joining Alex on the call are Alan yourself, Chief Financial Officer.
Doctor Ian Fraser President of early development, and Paul <unk>, Senior Vice President of business and corporate development.
At the providing of marquee program there'll be a brief Q&A, which Alex Alan Ian and Paul will be available to answer your questions with that it's my pleasure to turn the call over to Alex. Thanks.
That's great. Thanks, Shannon and thanks to all of you for joining us on the call. This morning.
Another solid quarter progress across our two clinical stage assets, most Napa Bard and <unk>, we are super excited to announce our collaboration and license agreement with Sanofi for the development and commercialization of <unk>.
So what I'd like to start off by doing. This morning is just provide an overview of the structure and strategic importance of this collaboration with Sanofi.
In brief Sanofi will obtain exclusive commercialization rights for <unk> outside of the U S and that will allow fulcrum to focus our efforts on planning for a strong U S. Commercial launch in 2020. This collaboration allows both parties to do what we each do bad.
It combines vulcan's expertise and Fsh D with Sanofi exceptional regulatory development and commercial capabilities across approximately 100 countries outside the U S. Importantly, having a partner like Sanofi will allow us to reach.
Patients in ex U S markets quicker than we could do on our own and mitigates the commercial execution risk that is typically inherent for any biotech company undertaking the commercial launch of its first product on its own.
We believe we have selected the best possible partner for those map of Bard and we look forward to delivering on our shared commitment to addressing the unmet need of patients with fsh date.
We're also very pleased with the deal terms, which allows us to retain substantial ex U S value in both the near term and over the product's lifecycle.
In short.
We will receive $80 million upfront, which enables us to fund the launch of <unk> in the U S with non dilutive capital.
We're also eligible to receive up to an additional $975 million in specific regulatory and sales milestones along with a tiered royalties starting in the low teens of annual net sales of <unk> outside of the U S.
The companies will also share equally in the global development costs were lowest map of <unk> going forward.
Now before providing an update on our two clinical assets <unk> analyst map of Mod I would also like to take the opportunity to welcome our newly appointed Chief Medical Officer, Dr. Patrick Horn and accomplished industry veteran who has successfully guided multiple therapies in the rare disease space through late clinical.
<unk> development regulatory approval and commercial launch this is an ideal time for past appointment and with the complementary expertise of Dr. Frazier, we are well positioned as we advance toward near term inflection points.
Sent his apologies as he is unable to attend today's meeting on account of a family emergency.
So let's go a bit deeper and start with our most advanced program <unk>, which as most of you know is an oral small molecule selective <unk> 38, Alpha beta map kinase inhibitor that inhibits stuck for expression and thus prevent downstream muscle that death in patients with Fsh day.
It.
As a quick reminder, FX HD is a rare form of muscular dystrophy with an estimated U S prevalent patient population of 30000.
<unk> is characterized by a slow but relentless loss of muscle function year after year, resulting in significant impairment of upper extremity muscle function and mobility and <unk>.
While there is a degree of heterogeneity in the onset of disease progression or efforts HD. Many patients are unable to perform daily life activities that you would I take for granted and thus are unable to live independently Ulta.
Ultimately, 20% of Fsh D patients become wheelchair bound.
Currently no approved treatment options for these patients, which underscores the significant unmet need for this debilitating disease.
Our phase II study the readout for trial was recently published last month in the lancet neurology and demonstrated improvements in functional outcomes as measured by reachable workspace structural outcomes as measured by muscle fat infiltration and patient reported outcomes for patients treated with <unk>.
All as compared to placebo.
Building on the encouraging clinical benefit and favorable tolerability observed in our phase II trial.
We completed enrollment in our global Phase III trial for <unk> in September of last year with a total of 260 patients and as of the end of April of this year, a 146 of the 260 patients had completed the 48 week treatment period and.
144 of these patients.
Elected to continue into the open label extension of this study in a fully blinded fashion. This very high percentage of patients opted to move into the open label Phase is similar to what was observed in our phase II clinical trial and indicative of the high unmet clinical need for patients with fsh.
Dave.
We are on track to report top line in the fourth quarter of this year, which will bring us one step closer to delivering the first ever FDA approved therapy for patients with Fsh date.
Now as a quick reminder, our phase III trial. The reach trial. It is a well powered 48 week trial intended to be registration, enabling both in the U S and in ex U S geographies. The primary endpoint for reach is the change from baseline in the relative surface area or our SA which is a <unk>.
Auditive assessment of reachable workspace.
RSA as a measure of upper extremity range of motion and muscle function that specifically evaluates shoulder and our mobility using three D motion sensor technology and has been shown to correlate with abilities to perform certain activities of daily living.
In our phase two study <unk> demonstrated a 10% net change in the RSA score relative to placebo at 48 weeks based on our collaborative interactions with FDA and in particular with the clinical outcomes assessment group a co op at FDA. We're currently.
Assessing the extent to which a specific change in the RSA score is meaningful to patients. Additionally, key secondary endpoints include muscle fat infiltration or <unk>, which is an important marker of disease pathology measured by whole body MRI.
Solar dynamometry as well as self reported quality of life measures and health care utilization questionnaires that will help inform our thinking on our payer strategy as we begin for a commercial launch here in the U S. Taken together, we continue to take important steps forward.
Third to position fulcrum for commercial readiness.
Now turning to <unk>, our oral hbf inducer for the potential treatment of patients with sickle cell disease or <unk> for short.
The elevation of fetal hemoglobin or hbf is a validated therapeutic rationale for SCD, a lifelong inherited blood disorder that severely impaired quality of life for approximately 100000 people in the U S and approximately $4 4 million people worldwide.
This makes sickle cell disease, one of the most prevalent non malignant hematologic diseases.
Now historically the standard of treatment for ICD has involved blood transfusions pain medications and Hydroxyurea and Hydroxyurea, but all of these treatments only focus on symptom relief and while exciting scientific progress that enable the advancement and more recently the approval of gene editing in therapeutic approaches.
We believe there remains a high unmet need for a safe and accessible therapeutic option that are broadly protective of SPD symptomatology as.
As a first in class oral small molecule Hbf inducer, we believe <unk> has the potential to address this unmet need.
So in August of 2023, the FDA lifted the clinical hold on the phase <unk> study, we called the pioneer study it.
It is important to note there were no changes in the protocol defined dose escalation scheme or the three month treatment duration. We continue to work expeditiously to Reinitiate. The pioneer study and we have activated several new sites and are building key relationships with leading positions in the SCD community.
Cohort three of the phase <unk> trial will evaluate <unk> at the 12 milligram once daily dose with a dosing duration of three months followed by cohort four at the 20 milligram. Once daily dose also for three months, both cohorts are expected to enroll approximately 10 patients.
We look forward to building on the encouraging clinical data obtained prior to the clinical hold which demonstrated that <unk> increased total hbf of a magnitude that could translate into a meaningful improvement in disease severity.
Specifically after only 42 days of treatment, we observed up to a 10 percentage point increase in hbf from baseline.
Our total hbf of approximately 25%.
We believe that <unk> as an oral hbf inducer has the potential to provide a differentiated therapeutic option for patients living with sickle cell disease addressing the unmet significant unmet need in sickle cell in the sickle cell community remains a key priority for us and we are excited to be.
On this momentum in the years ahead.
And so with that update on the business. Let me now turn it over to our Chief Financial Officer, Alan Musso to run through our financials Alan over to you.
Thanks, Alex.
Ill now go over our financial results for the first quarter ended March 31 2024.
As of March 31, 2024, cash cash equivalents and marketable securities were $213 3 million.
As compared to $236 2 million as of December 31, 2023.
The decrease in our cash position of $22 9 million is due to net cash used in operating activities.
As of March 31, 2024 on a pro forma basis, considering the $80 million milestone due under the collaboration and license agreement with Sanofi.
Our cash cash equivalents in marketable securities were $293 3 million.
We have no collaboration revenue in the first quarter of 2024 compared to <unk> 3 million for the first quarter of 2023.
The decrease was attributable to the completion of our research services during the fourth quarter of 2023 under our myocardial collaboration agreement.
Research and development expenses were $19 8 million for the first quarter of 2024 as compared to $16 7 million in the first quarter of 2023.
The increase of $3 1 million was primarily due to increased costs related to the advancement of the reach clinical trial.
General and administrative expenses were $10 1 million for the first quarter of 2024 as compared to $11 5 million for the first quarter of 2023.
The decrease of $1 4 million was primarily due to decreased employee compensation costs.
And our net loss was $26 9 million for the first quarter of 2024 as compared to $24 8 million for the first quarter of 2023.
Finally based on our current operating plans, we now expect that our cash cash equivalents in marketable securities together with the $80 million upfront payment to be received from Santa Fe.
Be sufficient to fund its operating requirements into 2027.
With that let me turn it back over to you that's great. Thanks, so much Alan so before opening it up for questions. Shannon I just wanted to remind everybody of the key events of this quarter, we selected the ideal partner incentive fee to.
To commercialize <unk> outside the U S. We extended our cash runway into 2027, we enriched our leadership team and we activated several new sites for our phase one the pioneer trial of <unk>. We remain on track to report top line data for the phase III reach trial in the fourth quarter.
2024, and continued to prepare for the potential NDA filing and commercial launch of <unk> in the U S. We look forward to building on this momentum in the months and years ahead and with that Shannon, Let's go ahead and open it up for questions.
Thank you to ask a question. Please press star one on your telephone away for your name to be announced.
To withdraw your question. Please press star one again.
Please standby one compile the Q&A roster.
Oh, it's including <unk>.
Our first question comes from the line of Edward <unk> with Piper Sandler Your line is now open.
Edward: Great. Thank you very much and congratulations on the <unk>.
Partnership on all the progress on the corner.
Yes.
Thanks Ted.
So.
Quick question.
When it comes to actually manufacturing drug and groups like that for our.
Partnership can you walk us through how that works.
And then.
Just anything else, we should think about in terms of.
Final.
Things have moved to happen.
The phase III data, obviously, the final patient Vincent so all of that stuff, but just anything else that you have.
So we're focused on as we drive towards the data in the fourth quarter for a low smartphone. Thank you, yes, it's great Ted Thanks, so much and joining us on the call is is Paul Bruno and Paul is our head of corporate strategy and business development really the individual at full Graham who who really led the.
The deal efforts with Sanofi, So maybe Paul I'll turn that over to you to address the manufacturing question and then a more general question Ted.
Yes.
So right now the plan is for us to continue supplying for both clinical and commercial.
Globally, there is the opportunity and flexibility for <unk> to take over manufacturing and supply in future.
Great. Thank you.
And then just in terms of final work towards.
Phase III readout anything we need to be focused on thanks.
Yes.
No nothing nothing off hand, but maybe maybe I'll turn it over to Ian This is yes, no thats all pretty much on track and unaffected by this week, we are proceeding with that.
We know who the last patients in the study are where they are and obviously, we're working with those sites to make sure. There are no delays there, but that continues unaffected at this point.
Customers are a better partner congratulations guys yes.
Thanks, so much.
Speaker Change: Thank you.
Our next question comes from the line of Gregory Renzo with RBC capital markets. Your line is now open.
Alright, good morning, Alex and team congrats on the progress and the deal.
Thanks for taking the questions. Thanks, Greg.
And maybe just a couple from us.
First question, when we look across the competitive landscape for <unk>.
FSIC development, especially when it comes to trial design and endpoints, maybe beyond <unk> expression. We do know that affinity plans to report data on the changes to gene expression downstream deducts for I'm. Just curious what can you tell us about less Napa <unk> ability to impact that expression downstream index or and maybe how.
Can we think about that.
Most of that by being positioned competitively in light of this.
Yeah, Great question, Greg and let me start and then I'll turn it over to Ian for some more detail and yes. Our video has talked a lot about the fact that Aoc 10 20.
Directly inhibits stuck for I think the clinical impact of that.
Still remains to be seen they have talked a lot.
About being able to measure gene downstream.
<unk> four because of the challenges that we've spoken about and they've spoken about about the stochastic nature of duck floor and how difficult it is to measure.
Now, we do know that roadmap and Mod works upstream from docs for but we also know that roadmap of Mod.
Can reduce duck for gene expression in preclinical models and we also know that <unk> has been able to reduce gene expression that our downstream deduct four in preclinical models.
As well and maybe I guess and just to elaborate on that a little bit maybe I'll turn it over to you to maybe talk a bit more detail about some of the deals that we have been able to reduce downstream deduct for.
Absolutely, yes, all of the work that was done to identify less map modest.
Potentially useful agents in FSA HD was done in vitro in cells derived from patients with FSA.
The mile blasts from those patients differentiated in vitro into <unk>.
In that process docks for typically is up regulated we've been able to show across a range.
Of sales derived from different patients, both fsh E one and fsh.
To that Theyre very clearly is a significant reduction in dux for itself, which you can measure in vitro somewhat more readily than you can in vivo and that along with those concentration dependent reductions index for across across those <unk> cultures.
C. A concomitant decrease in a number of the downstream genes that we know are impacted.
By docs for that are regulated by docs for until a concentration dependent decrease in all of those as well as decreases in.
Markers of apoptosis in the muscles and ultimately decreases in muscle cell death. So that mechanism is fully fleshed out in cultures and Alex alluded to the challenge in the clinic is is demonstrating that.
In the biopsies from these patients and I think one of the challenges. In addition to the stochastic nature of <unk> four expression is the variability in the tissue content on the biopsies in the clinic. These are not normal muscle. So there's a bunch of fact fibers tissue inflammatory tissue extracellular matrix components.
Speaker Change: And so on.
That leads to the variability in document and documenting that but the overall pathway in vitro in those magnitude cultures is very clear concentration dependent reduction in ducts floor and similarly reduction in the downstream genes impacted by docs for.
That's great really appreciate that and then just on the deal. This morning, certainly heard you mentioned the benefit of sanity, reaching multiple countries in Europe building out to focus.
State side and on the U S. Just wanted to ask just to receive a little more color on maybe some of those additional inputs that you and the team and in consideration of these.
Deal terms, reflecting the full value of outlets Napa Mod.
Just talk through some of the deal terms and what input that you use to feel comfortable with the value calculus here. Thanks, so much and congrats again thanks.
Thanks, Thanks, Greg I'll start and then Paul if I Miss anything please please jump in.
I think first and foremost we've been very clear that it has always been our goal to try to find a partner outside of the U S and I think the reason for that is.
Finding a partner outside the U S allows us to do a couple of things Greg right. It allows us to get <unk> to patients around the world faster than we could do on our own simply because of the scale of the commercial infrastructure that setup behalf and then with the with the upfront payment and the cost sharing we.
We can take that capital that non dilutive capital and really apply our effort and more importantly, our focus on ensuring that we can have the best possible.
Launched here in the U S, which obviously we have been.
We've been we've been obviously gearing up for.
I think one of the reasons youll see that the.
That the deal terms were quite competitive and significantly above comps for products that have yet to flip over the phase III card is I think simply because of the competitive nature of.
There was a number of parties that were interested not surprising fsh D is a large market.
In the U S about 330000 patients some estimate about 1 million patients outside.
The U S and there are currently no treatment options and.
<unk> has what we believe to be probably about a three year head start before the next closest competitor comes into play. So I think for all of those reasons, we could not be happier with the partner that we selected it allows us to get the drug passenger patients that we could do on our own outside of the U S. But it also allows us.
US as a small biotech company to focus on what still continues to this day to be the most profitable and lucrative market in the world that being the <unk>.
U S market.
Fantastic. Thank you thanks, Greg.
Thank you. Our next question comes from the line of Karen Johnson with Goldman Sachs. Your line is now open.
Thanks, and good morning.
You mentioned in that answer to the last question that you plan to use this upfront capital and supporting the launch I guess what are your top priority action items that you think will be necessary to set up a strong launch out the gate.
And then I'd be curious if you could talk to what you view as <unk>.
Potentially bringing to the table as a potential partner as a partner now for ex U S. Commercialization beyond just kind of the financial terms. Thanks sure sure no absolutely. Thanks, Thanks Graham for for for asking the question, Yes, I think one of our key.
Speaker Change: Priorities on the commercial side is to bring on board a very very strong chief commercial officer that has experience of launching rare diseases in the pharmacy benefit portion of.
Of the payer space and we're having a number of conversations with a number of very very talented chief commercial officer that meet that criteria. So that's obviously going to be our our first important higher and then we will be doing a couple of additional hires this year.
Particularly around market access and we more than likely we will end up recruiting somebody who is exclusively focused on ensuring that genetic testing does not become an impediment to access at at at launch.
So I think those are some of our key priorities right now for the U S. I think what <unk> brings and we talked a little bit about this during our prepared remarks, I think beyond the financials.
I mean, they have a they have a very very strong neuromuscular franchise with their programs.
Such as fab resign and Cerezyme by design I mean, that's a $3 billion.
Portfolio globally, so they've got a very very strong commercial footprint, but beyond that they obviously have very strong.
Speaker Change: Regulatory as well as clinical expertise in the neuromuscular space as well so having that expertise as we were negotiating with the various regulatory agencies around the world as well as.
With the various pricing and reimbursement agencies in various countries around the world I think that that.
That experience that <unk> brings to the table will be will be invaluable.
Okay. Thank you. Thank you Karen.
Thank you.
Our next question comes from the line of Justice Schwartz with Leerink Partners. Your line is now open.
Great. Congratulations on the deal I have a question on.
Low smack Mod and also one on <unk>. So first time alone most of that but I was just wondering if you can tell us how your work to establish the clinical meaningfulness of certain changes in our Ws is going.
Can you outline.
Sure.
The process of performing that analysis, and where you are in that process and when we might see.
Some some data on that front.
Yes, that's great. Thanks, so much Joe and thanks for your kind words earlier, yes, I think to answer the question. We're doing a lot of work on clinical meaningfulness I've been working very closely with them.
The <unk> division of the FDA, but maybe to get into some of the specifics let me turn it over to Ian Yes. Thanks, Alex. Thanks, Joe. So there are three main steps.
Ian: As part of the work that's ongoing and that we have aligned with with the agency.
Ian: First is a survey.
That is now being completed and that is asking patients with fsh D. What is most important to them in terms of activities of daily living so that was a 100 patient survey unrelated to treatment with <unk>.
Again that is completed.
The two other components are ongoing at the moment. The first is a cross sectional study again in patients with FX, HD, but not being treated with <unk>.
And performing reachable workspace assessments on those patients and then matching up the ability of those patients to do the important activities of daily living which were identified in the initial stack and so thats my questionnaire in those patients so mapping reachable workspace there to the question.
Their ability to perform those activities and that assessment recruiting those patients into that is active and ongoing at the moment, but that's going to be a total up about 60 patients and then the last component. The third component of this is as part of the reach study so patients who've been treated <unk>.
IBO undergoing structured exit interviews from the study.
To get insight from them.
What difficulties they had with activities of daily living as part of their participation in the study that work is ongoing and we will only complete once the reach study itself is complete and we have.
Have all the data that we expect all of these.
With data to be pulled together and available in and around the same timeframe as we expect the top line data from the reach study.
And that those will be around the same time.
Okay. Thanks, that's very helpful and then.
Can you update us on site activation in the ongoing study for <unk> and at what point do you think you could share some data from this study either in terms of calendar timing or how youre thinking in terms of numbers of patients who are aiming for before giving us the first look.
That would be very helpful. Yes, absolutely. Thanks, Joe I'm happy to take that one yes. So.
So we will be sharing information when we have completed the 10 patients in the 12 milligram <unk>.
Cohort and all 10 of those patients have completed the three month study duration and we intend to share that with everybody in advance of cohort four which is the 20 milligram cohort again, our expectation there is that we would share the 20 milligram cohort data once those 10 patients have completed the full.
At three months of up dosing, we have been pleased with the with the site activation efforts to date I would say that there is strong interest from many sickle cell centers about the promise of having a once daily oral medication that has the potential to raise levels of hbf to that seen with the <unk>.
Cell and gene therapies.
Haven't yet provided any specific guidance on when we would be able to share that information because what we want to make sure that we do Joe is I.
I mean first and foremost we want to make sure that we don't give a number that we don't feel comfortable with in terms of a particular quarter. So what we said to folks is that we want to have a critical mass of patients in that 12 milligram cohort before we come back to everyone and let them know what in what quarter will have the 12.
A subsequent quarter.
The 20 milligram and I think just having that critical mass of patients. It allows us to know a couple of things right. It allows us to sort of see what that enrollment trajectory looks like but it also allows us to see which sites have been the strong enrollees and to be able to go back to those pis at those sites and really ask them point blank how many more patients that they have so until.
We have that critical mass of pace or once we have that critical mass of patients and we can more accurately predict what that enrollment trajectory looks like that'll be the point in time in which we'll come back to everybody with more specificity around which quarter. We would share. The 12 milligram followed by the quarter in which we would share the 20 milligram.
Very helpful. Thanks, and congrats again thanks.
Thanks, Joe.
Thank you as a reminder to ask a question at this time. Please press star one on your Touchstone telephone. Our next question comes from the line of Dae Gon Ha with Stifel. Your line is now open.
Hey, good morning, guys. Thanks for taking our questions and congrats on the deal on progress as well.
I'll start with the last map my question in your prepared remarks, Alex you talked about about 146 of your patients being complete as of April 24, 144, electing to go into open label. So curious in terms of the Sanofi deal.
Ian: I guess when did this deal kind of get underway and to what extent, where they kind of given the access to the data room I know its blinded, but just kind of curious how much access they have there and I've got a follow up sure absolutely Dagon and maybe too and thanks for your kind words as well maybe to answer that question I'll I'll turn it over to Paul Who's really.
Ben the person that's been leading the charge on the <unk>.
We've been in conversations obviously for some period of time.
With.
With the folks at Sanofi, but Paul do you want to maybe just talk a little bit about kind of when these conversations got got got quite serious yes, the coverages have been taking place.
Over the past year again, it's been a competitive process with a number of parties. They have had broad access to all the confidential information related to the program I will explicitly note that they have not seen any blinded reach data neither have we.
And that they've had broad access in the program materials.
Okay, great. Thanks for thanks for the details Paul.
Maybe the next question is when you think about the Santa fee infrastructure, especially ex U S access to ex U S. Regulators I guess can you just remind us where things stand in terms of the phase III reach design, how comfortable is the EMA as well as ex U S regulators about that particular endpoint as it pertains to fsh deal profitability.
Thanks, So much guys, yes, absolutely dagon. Thanks for the question, maybe let me turn that one over to Ian.
Yes, yes, thanks, Dave.
<unk> engaged with the European regulators there was some initial engagement prior to the study which was done on that on a country by country basis.
Rather than central process with EMEA, but more recently we have engaged.
With the EMA.
Somewhat somewhat late in the process of Wilder, while the trial was underway I think they recognize the endpoints that we have established they also recognize that.
Our interactions with them.
We're off to the client level already being initiated until opportunities to impact that.
Limited, but I think there is.
And understanding about primary endpoint.
<unk>.
And the way that we structured the secondary endpoints.
And I think overall.
The overall agreement that that seems to be a reasonable designed from that point of view.
Great. Thanks, so much and congrats again guys great. Thanks Dae gon.
Thank you.
Next question comes from the line of Matthew Biegler with Oppenheimer. Your line is now open.
Hey, good morning, guys I'll extend our congrats as well I just wanted to maybe tag along to that last question about the partnering process here and specifically if you can comment on how receptive the partners were to the RW OS endpoint.
Is this something that they have seen before.
It kind of require a lot of handholding.
Paul and team throughout the due diligence process, yes.
Yes, great question, Matt and maybe add to that I'll, probably bulk water can add to that would be it would be Paul.
Thanks, Matt.
No we have been broadly educating folks on our W. S. I don't think to greater degree than you would for any other novel endpoint I think it was also one of the major reasons that we're excited about <unk> as a tenant partner between their deep neuromuscular expertise, but also their expertise with novel endpoints.
It's really wasn't ideal match for bolt on particularly for this rare disease.
Ian: Drug development program.
Thanks.
Okay. Thanks, Matt.
Thank you and I'm currently showing no further questions at this time I would like to hand, the call back over to Alex for any closing remarks, that's great. Thanks.
Thanks, So much Shannon and thanks to all of you for joining again, maybe just in closing we as always remain deeply committed to treating the root cause of genetically defined rare diseases, and bringing transformative therapies to patients and before we conclude today's call as I always like to do I would like to extend my sincere appreciation and gratitude to my.
Fellow fulcrum teammates to the physicians, we work with to advance our clinical studies, and finally, and most importantly to the patients and their families. Thanks, everybody who joined this morning, and please stay safe and healthy.
This concludes today's conference call. Thank you for your participation you may now disconnect.
Nicely done great job.
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