everyone, and welcome to the Epelis Pharmaceuticals Conference Call to discuss their collaboration with Sobeys. Today's call is being recorded. At this time, I'd like to turn the call over to Tracy Veniz, Vice President of Communications at Apellis.
Good morning, and thank you for joining us to discuss Apellis' strategic collaboration with Sobeys for systemic pegcetacopalan. For those participating by conference call, slides are available via webcast@apellis.com. Before we begin, I would like to point out that we will be making forward looking statements that are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties and our actual results may differ materially. I encourage you to consult the risk factors discussed in our SEC filings for additional detail.
On today's call, I am joined by Co Founder and Chief Executive Officer, Doctor. Cedric Francois, who will discuss our new collaboration with Sobe. Joining us for Q and A will be our Chief Medical Officer, Doctor. Federico Grossi Chief Financial Officer, Timothy Sullivan and Chief Commercial Officer, Adam Townsend. Now, I am pleased to turn the call over to Cedric.
Thank you, Tracy, and good morning to everyone on the call and joining via webcast. We are very excited to announce our new collaboration with Sobeys for the global co development and exclusive ex U. S. Commercialization rights for systemic pexitacoplam, our targeted C3 therapy. As part of the deal, Aperis retains the U.
S. Commercialization rights for systemic pexitacoplam as well as worldwide commercial rights for intravitreal pexitacoplan in geographic atrophy or DA. Aperis will receive up to $1,250,000,000 in cash and commercial and regulatory milestone payments, plus tiered double digit royalties. This transformational collaboration allows us to expand on the broad platform potential of targeting C3 across multiple rare diseases that impact over 275,000 patients around the world. First, it enables us to advance systemic pexitacopalan in 5 parallel registrational programs across multiple rare diseases.
These include our existing program in paroxysmal nocturnal hemoglobinuria or PNH, 2 new registrational programs that we plan to start in hematology and our recently initiated studies in nephrology and neurology. All 5 registrational programs will build on remarkable success of bexitacoplim in its first positive Phase 3 study in PNH, which validated the platform potential of targeting C3. 2nd, the deal underscores our confidence in geographic efficacy as Aperis keeps global rise to this fully enrolled Phase III program with blockbuster potential. Finally, this collaboration further strengthens our already strong balance sheet, which we believe will extend our cash runway into the second half of twenty twenty two. Our collaboration with Sobeys is the result of a robust process conducted with numerous medium and large parties that sought to partner with us for our systemic seksitagoplan program.
We chose Sobe, a global leader in hematology and rare diseases, because this collaboration will be as important to them as it will be to us and because they are committed to expanding the development of systemic pexithacopan. Sobeys shares the collaborative spirit that we cherish at Aperis, recognizes the platform potential of systemic plexitha co plan and perhaps most importantly, shares our values and deep commitment to patients. Sobe has an established international infrastructure with a strong presence in key global markets that currently commercializes 15 products, and we expect that they will leverage these strengths for the ex U. S. Launches of systemic pexitacopalan, beginning with the anticipated European launch in PNH.
Together with Sobe, we are confident that we can maximize the broad platform potential of our targeted C3 therapy. Our systemic pexida occultime programs are targeting rare diseases with significant unmet need across hematology, nephrology and neurology. By controlling complement activation centrally, pexitacopalan offers the opportunity to become a transformative new therapy in each of these rare diseases, where patients have few or no treatment options available today. Also, as shown on the slide, our GA program remains the largest indication for pexitacopalan. This continues to be an important element of our strategy to fully retain the global rights to this program.
We believe that our GA program represents a rare opportunity to make a difference in the lives of 5,000,000 people at risk of blindness with no treatment options available and few opportunities on the horizon. Recent data on intradigial following 18 months of treatment and an early geographic atrophy have further validated targeting C3 in this area of significant unmet need in ophthalmology. And now I'd like to discuss our expanded clinical development plan for systemic texitacopan with Sobe, which will be overseen by a joint development committee. I'll begin first with hematology. PNH, which affects approximately 15,000 patients worldwide, represents the 1st potential indication to market for systemic pexitacopan and the most advanced program included in our collaboration with Zolian.
We recently achieved an important step forward in Europe with the European Medicines Agency validating our marketing authorization application or MAA for pexitacoplan in October, and we expect a decision by the U. S. Food and Drug Administration regarding the acceptance of the new drug application and a prescription user fee act or PDUFA target action date in the Q4 of 2020. These submissions were based on results from the Phase 3 PEGASIST study, which met its primary endpoint, demonstrating the superiority of texitacopalan through ekadizumab with a statistically significant improvement in hemoglobin levels at 16 weeks. Moving forward, Sobe will be responsible for all regulatory activities for systemic pexida coplan in ex U.
S. Markets, and we plan to transfer the European MAA to them. We remain on track to present 48 week top line results from the PEGSIST study later this year as well as top line results from the Phase 3 PRINCE study in treatment naive patients with PNH in the first half of twenty twenty one. As part of our collaboration with Sobeys, we will also further explore the potential of systemic texitacofen within hematology. We plan to start 2 new registrational programs in colic glutenin disease or CAS and in hematopoietic stem cell transplantation associated thrombotic microangiopathy or HSC gTMA.
Sobeys with its world class hematology franchise will take operational responsibility for these programs. In CAD, our Phase 2 open label trial demonstrated increases in hemoglobin levels in patients following treatment axitacopalan as well as reduced markers for extravascular and intravascular hemolysis. Fasciate Fatigue scores showed an improvement of 9.7 points from baseline, tripling the 3 point improvement threshold that is considered a clinically significant increase. Pexitacopalan was generally well tolerated and no serious adverse events were reported. Approximately 10,500 patients in the U.
S. And Europe are living with this rare disease and there are currently no approved therapies available. So be glad to initiate a Phase III trial for CAB in 2021. HSC TMA is a new hematological indication for systemic taxidermolybdenumab. We believe that targeting C3 could help treat conditions associated with TMA, where high levels of complement activation are common.
Our registrational program will study texitacopan in patients with HSCT TMA, where we believe texitacopan can be a best in class life saving therapy. VMA is a disease where blood clots form in small blood vessels and is an often lethal complication of HSCT. There are approximately 9,018,000 transplants conducted each year in the U. S. And EU, respectively.
TMA incidents can be seen in up to 40% of cases. And as you can see in the graph on Slide 10, TMA has a significant impact on the mortality of HSCP patients. There is a substantial unmet need for a treatment for these patients and Sobeys plans to start a potentially registrational Phase II study in 2021. Next, in nephrology, Aperis will continue leading the development activities for the registrational program we recently initiated in immune complex membranoproliferative glomerulonephritis or ICMPGN and C3 glomerulopathy or C3g. Primary ICMPGN is a new indication for Aperis and like C3g, primary ICMPGN is a rare disease that often leads to kidney failure.
With these trials, Aperis and Sobeys will be the only companies actively studying a potential treatment for patients with IC and PGM, a disease where both the alternative and classical pathways have been implicated. Approximately 18,000 patients in the U. S. And Europe suffer from ICMPEGM and C3 gs, which have no approved medicines. Our open label Phase II discovery trial, which evaluated taxitacopalan in patients with C3g, was designed with a primary endpoint of change from baseline in proteinuria at week 48.
Proteinuria or loss of blood proteins in the urine is a common finding in C3 gs patients and an important marker of kidney damage. Data at week 48 were recently presented at the American Society of Nephrology Kidney Week and shows that texitacopan demonstrated a 73% reduction in mean proteinuria from baseline, highlighting its potential to address the underlying cause of C3G. Importantly, this reduction in proteinuria was accompanied by a corresponding increase in mean serum albumin. No serious or severe adverse events were reported, and texitacopalan was well tolerated overall. Our registrational program in ICMPGN and C3G includes Phase II and Phase III studies.
The Phase II trial is focused on the histopathology of the kidneys and the first patient is expected to be dosed by the end of the year. We plan to begin the Phase III study in the first half of twenty twenty one with reduction in proteinuria as its primary endpoint. Adelis will also continue to lead the registrational program we recently initiated with amyotrophic lateral sclerosis or ALS, a devastating disease with high unmet need and the first indication from our new neurology franchise. As we demonstrated in PNH, we believe that targeting C3 can set itself apart from C FANG, as well as other more narrow acting complement inhibitors as the most effective way of controlling complement in a wide range of serious neurological conditions. In ALS, individuals with the disease have high levels of activated C3 in the neuromuscular junctions, where the neurons communicate directly to the muscle cells.
Numerous studies suggest that the elevated levels of C3 present in ALS may be responsible for the chronic neuroinflammation that leads to motor neuron death. Therefore, we believe that systemic pexitacoblan by targeting C3 may have the potential to slow the progression of ALS, a disease that impacts approximately 225,000 patients worldwide. Our potentially registrational Phase II placebo controlled randomized study is enrolling approximately 200 adults with sporadic ALS, and the first patient is expected to be dosed by the end of this year. The primary endpoint will be the combined assessment of function and survival or CAF's rank scores at week 52. We believe that C3 plays a central role in numerous neurodegenerative conditions, and we look forward to becoming a leader in this field.
To summarize, we believe that Sobeys is the ideal collaboration partner to maximize the broad platform potential of our targeted C3 therapy. Together, we plan to rapidly advance systemic pexitacopan in 5 registrational programs across hematology, nephrology and neurology. We expect that this progress will occur in parallel to the commercial preparations for our first potential launch in PNH with Aperis focusing on the anticipated U. S. Launch and Sobe managing the European and rest of world markets through its global hematology franchise.
We expect that this collaboration will provide Aperis with bandwidth to prepare for the global launch of intradyspropexitacopalan NGA, which has blockbuster potential and for which Aperis has retained worldwide rights. Finally, this collaboration further strengthens our already strong financial position, extending our projected cash runway into the second half of twenty twenty two. We are proud to collaborate with Sobeys and look forward to working together to flawlessly execute the clinical development plan outlined today and deliver on the broad platform potential of our targeted C3 therapy, systemic pexitacopan for patients with serious rare diseases. For additional information on the financial terms and obligations of this collaboration, I will refer you to our press release issued this morning and the associated filing with the SEC. And before we move to Q and A, I want to thank our employees as well as the patients, investigators and investors who helped advance our pipeline to its current stage.
We look forward to this new chapter of growth for pexitagopan. And now operator, please open the call for questions.
Our first question comes from Justin Kim with Oppenheimer. Your line is now open.
Hi, good morning. Thanks for taking my questions and congratulations on the partnership this morning. Just we've spoken a lot about pipeline optionality and systemic complement mediated diseases. And it's been very interesting to see that evolve over the past year. Can you just talk a little bit about how you see C3 C3 targeted approaches being differentiated clinically and commercially for the Sobeys led diseases in CAD and HSCT TNA?
Sure. Thank you, Justin. And great hearing you. So in cholagutin disease, we have delivered proof of concept that I think you are familiar with. We administer pexitacopalan subcutaneously twice per week, exactly the same way we do in PNH.
And in our Phase III clinical trial, we hope to replicate the efficacy profile combined with the advantageous subcutaneous administration. In the hematopoietic stem cell transplantation setting for thrombotic microangiopathy, we will provide further details. But in general, I would say that C3 is, we believe, kind of a pivotal target within the context of TMA, where C5 and C3 have been studied individually in the role in thrombosis and our C3, we believe, offers significant advantages.
Got it. And maybe just a follow-up.
As broadly as you
think about the partnership, I know it mentions that APL9 would not pursue some of these listed indications. Just wondering whether 2nd generation molecules and molecules that maybe optimize the formulation or their sort of PK properties of pegzetoprolide would also fall under the agreement or not?
The agreement solely covers pegcetagopalan administered twice a week subcutaneous as it was used in the Phase III clinical trial in PNH. So not follow-up.
Okay, great. Thanks guys and congrats again. Thank you, Justin.
Thank you. And our next question comes from Anupam Rama with JPMorgan. Your line is now open.
Hey, guys. Thanks so much for taking the question and congratulations on the collaboration. A quick accounting question. For the $80,000,000 over the next 4 years, are they tied to development milestones? Or are they going to be recorded on a more linear basis?
And then just a confirmation question real quick. The Cedric, I think you mentioned that there is a joint steering committee. Is that for
all the indications or just the Sobei led indications? Thanks so much.
Thank you so much. I will let Tim take the financial question and then get to the second.
Sure. Thanks, Cedric, and thanks, Anupam. Yes, so it's the latter. These will get recorded more on a linear basis. These are R and D reimbursements fairly evenly spaced over that 4 year period.
Yes. Thank you, Anupam. And the answer to your second question is very simple. We are going to be talking about all of our developmental programs together in a true partnership fashion.
Thank you. And our next question comes from Jonathan Miller with Evercore ISI. Your line is now open.
Hey guys, thanks for taking the question and congrats. I'll join everybody else in saying congrats on what looks like a pretty good deal. So these are good partner for you ex U. S. Here.
My question is on ALS. I understand you're starting that trial, the Phase 2 this year, when you get first phase in. What's your expectation for data timing there and the competitive profile of pachytoplien and that indication given the dosing regime relative to other players in that disease?
Yes. Thank you so much, Jonathan, for that question. So ALS is obviously a disease where the unmet need is staggering and where new therapies are needed. The role of C3 has been studied extensively for a very long time in ALS. And within the complement pathways, as a particular target stands out as probably the most attractive one.
Now the twice week subcutaneous dosing is actually well tolerated and very convenient for patients. We know that from our trials in PNH. We're not guiding towards when these trials will be finished yet, but we believe that enrollment will be relatively straightforward, and we look forward to the outcome.
Thanks. One follow-up, I guess. I understand that you're maintaining your ex U. S. Rights to GA, which obviously is the big indication here.
What are your plans for building an ex U. S. Sales force and penetrating the global market there, given your ex U. S. Given your leveraging of ex U.
S. From Sobe for all those other indications? Yes. Thank you so much for that question, Jonathan. So geographic atrophy for us is just an extraordinary opportunity, both from a medical and a company perspective.
We will have the readouts 10 months from now or in Q3 of next year. So that's right around the corner. It's an opportunity where in the past couple of months, we have further discovered kind of efficacy profiles for pexitacopalan. We had the release with the late breaking talk setting that in retina areas where atrophy has not completely penetrated yet, but where the cells are at risk of dying, we have an effect with dexitaglutin at reducing the rate of progression to full GA. And then we also had, of course, the 18 month data on the small safety study that we ran with pexitacopalan before we engaged in our Phase III clinical trial.
So all of that has increased our confidence. We are super excited about having the global rights exclusive to ourselves as we go into that readout. And for the second part of your question, I will hand it over to Adam Townsend, our Chief Commercialization Officer.
Thanks, Ezra. Thanks, Jonathan, for the questions. Yes, so we've created a very And we And we'll be partnering in true collaboration style with Sophie with this team and then we will transition these great leaders across to really start to prepare for a global worldwide launch of geographic hatchery, which has blockbuster potential. So the expertise we hired, we will move across to GA. It's we were super thoughtful and when we were building out the team to make sure that we had all of the right people to help us really explore this GA opportunity.
Thanks so much, guys.
Thank you.
Thank you. And our next question comes from Steve Seedhouse with Raymond James. Your line is now open.
Good morning and congrats. Can you comment on the anticipated timelines for PNH approvals and launch, obviously, in regions beyond U. S. And Europe given Sobeys controlling that? And then also how the regulatory and commercial milestones split between P and H and everything else that's covered?
And I have a follow-up as well.
Thank you so much, Steve. So I'm not going to comment too much yet. As you know and as we've disclosed, our filings were done both with EMA as well as with the FDA in September. The file has been accepted by EMA, and we're waiting to get a PDUFA date from the United States regulators. These other indications, again, kind of part of the, I'd say, the attractiveness of the deal with Sobeys was their interest to collaborate with us in exploring these multiple new indications.
And as you know and can appreciate, it's very difficult to synchronize these indications medically, regulatory, commercially from a pricing perspective. And we found a partner in Sobeys that I think is going to allow us to do that really well. So time lines, you should think about the conventional time lines in terms of approvals. We believe that the PEGASUS study gave us the safety and the efficacy profile that will lead to approvals in the 2 territories and look forward to sharing more on that in the years to come.
Okay. And just wondering if you could split out the milestones between PNH and the other indications, if you can. And if not, just had a follow-up. I wanted to ask about the development costs, the anticipated development costs. So $80,000,000 is going to be reimbursed to Apellis.
It looks like Apellis is reimbursing Sobei for the studies in CAD and TMA. So I guess the first question is what amount do you anticipate reimbursing Sobei for those two studies? And then is the $80,000,000 to be reimbursed to you basically 50% of the costs of the other programs in PNH nephrology and ALS? Or is Sobeys share of those costs something other than 50%? Thank you.
Thank you so much. I'm going to hand that over to Tim to answer.
Sure. So we haven't broken out the P and H regulatory and commercial milestones versus the total of $915,000,000 which we've disclosed. So we don't have any more color we can offer there. But in terms of the development costs, this R and D reimbursement of $80,000,000 over the next 4 years was intended to be roughly fifty-fifty of the four trials that have been added in addition to PNH, so the CAD, TMA, C3G, ICMPGN trial and also the ALS trial. But we ended up announcing doing those on our own anyways.
And so what's really nice about this transaction in terms of those $80,000,000 in R and D reimbursement is that it effectively covers on a fully loaded basis, the 2 additional trials, the CAD and HSCT TMA trials over that period of time. So functionally and transactionally, what happens is they do reimburse us. And in effect, we pay them for almost the same amount for those two trials. So it's a really nice part of that story where we get these two trials added on to our existing development franchise for systemic phyticopalan.
All right.
Thank you so much.
Thank you so much, Steve.
Thank you. And our next question comes from Matthew Luchini with BMO Capital Markets. Your line is now open.
Hi, good morning. Thanks for taking the question and congrats on the collaboration. So I guess maybe just stepping back a little bit, why now? What is it about where the company is today versus maybe on the other side of GA or some other time point that made this deal make sense for the company? And then relatedly, it sounds like it was a pretty competitive process.
It sounds like the company was pretty adamant about maintaining the rights to GA. And so I'm just wondering if you could talk a little bit about how important maintaining those rights were as you were working through discussions other partners? In other words, maybe how much was keeping GA rights a sticking point for you guys in your discussions with others? Thank you.
Thank you so much, Matthew, for that question. So we have great belief in the geographic atrophy program, which we believe will be transformational in the retina. And we look forward to a long story there in the area of ophthalmology. As it relates to the deal, why now and why with Sobe? So as I mentioned during the call, Sobe because it is a company for whom this deal is as important as it is to us, right?
As you know, we deal with a large pharmaceutical company. It's easy to become deprioritized to that will not happen here. This is going to be a marriage or a partnership of equals, where we are going to jointly make this drug available to as many patients as possible in as many indications as possible in as many geographies as possible. So that kind of summarizes it there. Now why we did it why we did this deal in the first place, as you or as I mentioned during the call as well, because we can go wider and faster.
I mean, pexitai coal plant, if it has shown us anything so far, is kind of the exquisitely promising efficacy and safety profile that we have there. And I want to remind you that the mechanism behind or by which texitacopalan exerts its effect is, in our opinion, the magic, right? And that is a mechanism that we believe that in many indications will make a big therapeutic difference. To be able to do that efficiently, quite frankly, requires a partner for us, a committed partner to these multiple therapeutic areas. And that then opens up the bandwidth for us to be ready for geographic efficacy, which will be a FIDD positive, a transformational event for the company and, of course, the fact that we could further shore up our balance sheet, which was already strong.
So that's kind of are kind of all the elements that went into play.
Great. And just recognizing everything you just said, does Sobe have even like a right of first refusal? Should GA should your thinking on GA change or anything like that?
No. This deal is exclusively around systemic pexitacoplan administered twice per week simultaneously for systemic indication.
Great. Well, thank you for taking the questions and congrats again.
Thank you, Matthew.
Thank you. Our next question comes from Madhu Kumar with Baird. Your line is now open.
Hey guys, this is Rob on for Madhu. Congrats on the deal. I was just wondering how does this impact the partnership with the agreement with SFX
today?
Thank you so much for that question.
Sure. Hey, thanks for the question. So Apellis is still responsible for the SFJ payments. Sobe has agreed to fulfill diligence obligations to SFJ. And obviously, SFJ had to give their consent to the transaction, which they did.
Other than that, nothing has changed. Okay. Thanks. And I was also wondering, what happens if there's interest in additional indications?
You mean from to develop systemic pexitacultan? Yes. Yes. So we have in the agreement, we have a mechanism by which new indications can be pursued jointly as well.
All
right. Thank you.
Thank you.
Thank you. Our next question comes from Phil Meisel with Cowen and Company. Your line is now
open. Good morning. Let me add my congratulations on the deal. First one question on commercialization. How is the price the commercial price going to be determined in ex U.
S. Territories? Is there any mechanism in the deal to try to coordinate at 1 worldwide price or does so we have free rein in how they price in any individual territory?
Thank you very much, Phil. I'm going to hand that question to Adam. Adam, you are muted. I think, Adam, that your line is muted.
Adam, your line is connected.
Sorry, I think I was on mute.
So thanks for the question, Phil. Welcome to conference calls and the mute button. So yes, we've done some great work on pricing strategically, globally and ex U. S. We'll be sharing all of that work through the joint steering committees with our partners Sobe and they'll apply their expertise and experience as well.
And then move forward with choosing their pricing ex U. S. But we've got a great potential partnership and collaboration ahead of us.
So they have access to all the market research you've done. Ultimately, though, the pricing decision in their territories is theirs. Is that correct?
Correct. Correct.
Okay, perfect. And then just to follow-up on the IC MPGN and C3G study. I guess from the slides, I wasn't clear. Is that a combined study with both patient populations? Or are there going to be 2 trials in parallel in kidney disease run side by side?
Thanks.
Thank you so much for that question, Phil. So it will be combined study. Without providing further detail, you should expect that to be a stratification.
Perfect. Thanks for taking my questions.
Thank you so much.
Our next question comes from Brian Chang with Bank of America.
My first question is on the commercial front for PNH. Can you give us a bit more color, granularity on your preparation on the U. S. Launch? Any updates on your thinking around the size of the sales force to launch for this indication in both the European regions and also U.
S? And there may be some potential synergy with their existing infrastructure in hematology.
Thank you so much, Brian, for that question. I'm going to hand that one to Adam as well.
Yes. Thank you, Cedric. Thank you, Brian. So yes, we're flawlessly on plan for the execution of
the launch of PNH in
the U. S. So we are currently in the field and also where appropriate and virtually interacting with key opinion leaders, patients and partners appropriately. We're on track to build out our sales force, and we've done some great research looking at the right of sales force to address the prescriber base in the patient population. So we expect to be launching a sales force that's pretty lean, pretty nimble, but super sophisticated in these COVID times to be able to balance the in face meetings where they're appropriate and accepted by the physicians and also to work in a virtual environment.
So we're all on track. We're currently in the field, as I said, through pointing in the right directions for our U. S. Commercialization. Now, pointing in the right directions for our U.
S. Commercialization. Now Brian, you also asked about ex U. S. We had a robust plan again to launch lean and nimble teams.
We'll be sharing that plan with our partner Sobeys and sharing our insights on the prescriber base and the potential in each of those geographies. And then we'll be by their side as they execute their plans from an ex U. S. Perspective. So, Apellis is full steam ahead to commercialize PNH in the U.
S. And we're looking forward to helping our partner ex U. S.
Great. Thanks, Adam. Maybe one quick one on C3G as well. Notice that the NOBLE study is studying in the post transplant patients. So is the Phase 3 study that's about to start in first half next year also focused on post transplant setting?
Or is it going to be a broader indication?
That is correct. This will also be focused on post transplant.
Okay. So it will include patients before transplant as well, right? Before and after, yes.
Okay, great. Thanks, Cedric. Thank you.
Thank you.
Thank you. Our next question comes from Alethia Young with Cantor Fitzgerald. Your line is now open.
Hey, guys. Thanks for taking my question. Congrats on the progress and for squeezing me in my first Pappellis call here. Number 1, maybe just can you talk a little bit about like how decisions were made around who would maintain operational responsibility? And then I guess just near term and thinking about upcoming launches, how much kind of having some additional cash upfront kind of helped you kind of accelerate your business overall?
Thanks.
Thank you so much, Alexia. So as it relates to the operational responsibility, so we will act through these joint governance committees, which are across development and commercialization. We will be in charge of the developmental the operational developmental responsibilities in C3 gs and ALS, whereas Sobe will take the lead in colagglutinin disease and HSCT tTMA. And then for the second part of your question, I will hand that over to Tim.
Hey, Alethia, thanks for the question. So as you probably know, we ended the 2nd quarter with $833,000,000 in the bank. And then with this $250,000,000 upfront, that obviously extends our runway significantly, which allows us to support these 4 new indications that we had just announced, those first 2 and then these new 2 with Sobe. It allows us to execute a commercial launch in PNH in the U. S.
Next year. It also allows us to accelerate our early research programs, build out general operations. And then probably most importantly, it allows us to get through our GA readout for a primary endpoint in the Q3 comfortably without feeling like we have to raise capital and then also allows us to begin preparing for that global launch of GA that Adam was talking about. So we feel very good about our financial position post this transaction.
So maybe just one follow-up
on the first question. Just I guess my question is like how did you guys make those decisions? Like one, who would keep how did you decide that you would keep ALS for versus keeping cold to gluten? Can you just talk a little bit about that thought process between the two companies? Thanks.
Sure. Thank you, Alethia. So Sobeys is a company that has a long and deep story in hematology. So this is a field that they know extremely well and where they are a global leader. So it was a natural fit for us to hand that over to them.
Thank you. And I'm showing no further questions in the queue at this time. I'd like to turn the call back to Cedric Van Swolk for any closing remarks.
Thank you so much, operator, for navigating the works here. And to everyone on the call, thank you for joining us today. We are excited about this new collaboration with Sobe. And together, I am confident that we will maximize the platform potential of our targeted C3 therapy, systemic pexitacoplan, across a broad range of serious diseases. We look forward to continuing our progress and keeping you updated on our latest developments along the way.
Thank you so much for taking the time today, and we look forward to interacting on a 1 on 1 basis in the near future. Thank you.
Ladies and gentlemen, thank you for your participation on today's conference. This does conclude your program and you may now disconnect.