Acelyrin, Inc. (SLRN) Earnings Call Transcript & Summary

Hello, and welcome to today's call to discuss Alumis' planned merger with Acelyrin. [Operator Instructions] As a reminder, this conference call is being recorded, and the press release and slide presentation regarding the transaction are available at the Investor Relations section of each company's website. The archived replay can be accessed there following the call. I would now like to hand the call over to Martin Babler, President, CEO and Chairman of Alumis.

Thank you, and good afternoon, everybody, and thank you for joining the call. With me today are Mina Kim, Acelyrin's CEO; and John Schroer, Alumis's CFO, and we're excited to share more about our announcement. Before I jump in, I'd like to note that today's discussion will contain statements that are forward-looking. Please refer to each company's website for their publicly available SEC filings and identify certain factors which could cause actual results to differ materially from those projected in any forward-looking statement made today. Investors are, therefore, cautioned not to rely on these forward-looking statements. The companies do not undertake to update any forward-looking statements as a result of new information or future events. This presentation also includes preliminary financial data subject to the completion of Alumis' and Acelyrin's financial closing procedures for the year ended December 31, 2024, respectively. Actual financial results that will be reflected in each of Alumis' or Acelyrin's annual report on Form 10-K for the year ended December 31, 2024, once filed, may differ from the preliminary results included in this presentation. So let me start a little bit more about this transaction. What particularly is compelling about this transaction, and we'll speak more about this in a moment, is that it creates a highly differentiated late-stage portfolio that we are well positioned to advance through multiple upcoming milestones with significant combined financial strength. With that as a backdrop, I'll now spend just a few minutes providing an overview of the transaction terms. In this transaction, the Acelyrin stockholders will receive 0.4274 shares of Alumis stock for each share of Acelyrin they own. This represents a pro forma ownership of the combined company of approximately 55% for Alumis stockholders and 45% for Acelyrin stockholders. As for the leadership post closing, the current Alumis leadership team will remain in place to lead the combined company, and we will operate under the Alumis name. Our headquarters will remain in South San Francisco. And we look forward to welcoming 2 additional directors from Acelyrin's Board upon closing. Last, finally, we expect to close this transaction in the second quarter of 2025, following approval by both companies' stockholders and satisfaction of certain customary closing conditions. As I mentioned, through this combination with Acelyrin, Alumis will have an expanded portfolio of late-stage therapies as well as increased financial flexibility and runway. For those of you who are less familiar with Alumis' portfolio, I want to start with a broader overview of who we are and some of our upcoming catalysts in our pipeline. We're actually a relatively young company, about 4 years old, and we completed our IPO in July of last year. Our approach at Alumis is all about precision immunology, advancing medicines that move away from broad immunosuppression to very precise inhibition of the drivers of immune dysfunction. We leverage our data analytics and translational insights to better understand the immune system and choose targets, molecules and indications with the goal of optimizing outcomes for patients. Alumis originally started out by doing a broad assessment of many targets that are associated with immune-mediated diseases. And ultimately, we selected TYK2 because it is a genetically and clinically validated driver of immune dysfunction. We have 2 next-generation clinical stage TYK2 inhibitors with potentially best-in-class clinical profile. Our lead program is ESK-001, and we have an ongoing clinical program in psoriasis and in lupus. We're currently conducting a Phase III ONWARD program consisting of 2 clinical trials in moderate to severe plaque psoriasis, and we are on track for a topline data readout in the first half of 2026. And we expect topline data from our Phase IIb LUMUS trial in systemic lupus erythematosus in 2026 as well. The Phase III ONWARD clinical trial was supported by a Phase II clinical trial in which maximal TYK2 inhibition led to highly clinical -- high clinical responses in patients with moderate to severe psoriasis and was achieved at the highest dose. And ESK-001 was found to be generally well tolerated at those levels. We believe that ESK-001 is potentially best-in-class with broad potential to expand into additional indications and treat a diverse group of immune-mediated diseases. A-005 is our second TYK2 inhibitor, which is a brain-penetrant molecule and the first reported allosteric TYK2 inhibitor that has demonstrated the ability to cross the blood-brain barrier to address inflammation within the central nervous system. A few weeks ago, we announced positive Phase I data. We plan to initiate a Phase II clinical trial in multiple sclerosis in the second half of the year. And behind that, we're building a portfolio of other molecules. We expect to file an IND for the third clinical candidate later this year. We're excited that this merger now adds to our portfolio of lonigutamab, a subcutaneously delivered anti-IGF-1R for the treatment of thyroid eye disease. I'll talk more about this program shortly. I want to emphasize that the LUMUS program continued too as planned. We are looking forward to important key catalysts across our programs and everything remains on track. As it relates to lonigutamab, the program is promising and has shown compelling data that may support a best-in-class profile for the treatment of TED. It is the first subcutaneous anti-IGF-1R to have demonstrated robust efficacy in TED patients comparable to the IV administered standard of care and shown a favorable safety profile. So with that, lonigutamab has unique properties from the current -- compared to the current standard of care that may enable similar or better efficacy with an improved safety profile. We have done some preliminary work on the lonigutamab program and in lieu of pursuing Acelyrin's previously planned Phase III, we plan to undertake a comprehensive analysis, including reviewing all available data to identify the most capital-efficient plan to confirm differentiation for the program. We look forward to sharing our plan in the future. And basically, we'll continue to review this. So that's the high-level review of the pipeline. And we have a very attractive portfolio that is differentiated late-stage drug -- differentiated late-stage drug candidates with the potential to significantly improve the lives of patients with immune-mediated diseases. In today's environment, we believe that scale and diversity of the portfolio is extremely important and sufficient capital is critical. Together with Acelyrin, Alumis will be well capitalized with a much stronger financial base to carry us forward beyond the immediate readouts that I just outlined and put us on a strong position as we prepare for potential commercialization for ESK-001. I would like now to turn it over to Mina to share her perspective from the Acelyrin side and then to John Schroer, and I will then close with the combined portfolio.

Great. Thanks, Martin. This is an important and exciting time for the immunology space and for Acelyrin. Individually, both Acelyrin and Alumis have made tremendous progress exploring innovative approaches in immunology, where we have the opportunity to make a clinically meaningful difference for patients relative to standard of care. This merger follows a thorough strategic review process by our Board of Directors and the management team to determine the best and most value-maximizing path forward for Acelyrin shareholders and our patients. We're pleased with the terms, both the value achieved for Acelyrin stockholders and the development synergies for lonigutamab. As a combined company, Acelyrin and Alumis will leverage the benefits of our diversified pipeline, increased resources, combined development and commercial expertise and catalyst expansion to drive enhanced value for shareholders. Alumis has a strong track record of R&D success, and we believe this makes them the right partner to help optimize the development of lonigutamab. Lonigutamab has best-in-class potential in thyroid eye disease, and we will work hard to confirm its differentiation in a capital-efficient manner. I'm deeply grateful to our Acelyrin colleagues whose efforts have made today's exciting milestone possible and also to the entire Alumis team. I especially wanted to thank Martin and John for their partnership through this process. I'm excited that Alumis shares our mission of providing patients with life-changing new treatment options. And with that, I'll turn it back to Martin.

Thank you, Mina. And as just noted, Acelyrin shares our excitement about the many opportunities ahead of our combined company as well as our ongoing commitment to capital efficiency. I mentioned this at the very beginning of the call that being highly efficient with where we spend our dollars to the highest value potential opportunities has proven effective for Alumis and will continue to be our approach post close. Now let me hand it over to John Schroer to review our go-forward financial profile.

Thank you, Martin, and I would like to echo your excitement. As we included in our announcement this morning -- this afternoon, our respective 2024 cash position gives us a pro forma cash position of $737 million at the end of last year. Since our inception, Alumis has prudently managed costs to ensure that every dollar spent generates the greatest return. With our highly disciplined capital approach Martin outlined and continued operational discipline, we anticipate the transaction will provide us with cash runway into 2027 beyond our stand-alone basis of 2026. We are excited about the value creation opportunities that lie ahead for all of our stakeholders and both companies' stockholders. Martin?

Thanks, John. As we wrap it up, it's important to reiterate that we remain focused on executing against the key milestones that we have in front of us at Alumis, which will now be fortified with a strong balance sheet and an additional pipeline program that we will evaluate to determine the most capital-efficient path going forward. As a combined company, we have a strong portfolio that brings broad opportunities to make a significant impact for patients with immune-mediated diseases, and we look forward to sharing our progress with you. And with that, we can begin the Q&A.

[Operator Instructions] Our first question comes from the line of Eric Schmidt with Cantor Fitzgerald.

First, just congrats to both parties. This is the type of capital-efficient business combination that we should be seeing a lot more of in biotech, and I applaud both boards and management teams for making this happen. I guess first question, John, for you, the cash that you might be accumulating from Acelyrin at close, do you have an estimate of how much cash burn might be happening at the company between now and, say, I don't know, kind of looking at maybe the midyear closure. Does that sound right?

We expect the transaction to close sometime during the second quarter. We will be able to provide a bit more detail when the S-4 is available. The 2 companies will continue to operate independently up to that point of the close, but with an eye towards being capital efficient. Once we get closer to that time point, we would expect to be able to share more about what the combined company cash burn is and what the closing cash balance would be. But with that, I would reiterate that this transaction bolsters our balance sheet, provides us the cash runway into 2027 and creates the ability for us to read out all of the pivotal milestones that we've laid out on our website in 2026.

Okay. I hear you loud and clear. And one more housekeeping item. For the ownership combination that yields 55% and 45% of the respective parties, do you have the number of shares outstanding for either party -- each party in that ratio?

We will have more details in the filing. But within that, we are using approximately just under 55 million shares for Alumis and the total number of shares that will be issued to shareholders of Acelyrin at just around 44.7 million.

Our next question comes from the line of Thomas Smith with Leerink Partners.

Let me add my congrats on the deal. Just on lonigutamab, I was wondering if you could just elaborate a little bit on some of the analyses you intend to undertake here. As you think about a potential path forward, what would you need to see to advance this asset? And when do you think you'll be in a position to provide a little bit more clarity there?

Yes. So as we outlined in our press release, we're planning to reevaluate the development for the program and determine the optimal path forward. I think the most important thing is lonigutamab has some really interesting features. The question is how can we translate those into advantages and ultimately benefits for patients. And I think we're focused on really figuring out how that differentiation can work and what data will provide us that differentiation.

Understood. And maybe just a follow-up on that. Is that decision potentially gated by data that's being generated currently? Or is that analysis of additional data?

So we're going to evaluate what is available today, and then we will basically design our plan accordingly and roll that out. At this point, we don't plan to start a Phase III. Ultimately, we want to have the flexibility to evaluate everything and then basically make sure that we can share with everybody what the plan is for lonigutamab.

Understood. That makes sense. And just one last question. I was wondering if you could just provide an enrollment update on the Phase III ONWARD program. And I guess any notable trends that you're seeing on enrollment here as you guys progress towards the data readout in 2026?

Yes. On that one, all we can say, we haven't commented on enrollment. We have seen from some of the other oral trials in psoriasis that they enroll is generally a little bit faster than the injectable ones. And we would expect that that trend could be similar for us like for others, but we haven't really commented on enrollment exactly.

Our next question comes from the line of Katherine Wang with Jefferies.

This is Kathy on for Akash. So I was just wondering regarding Alumis, why do you think your drug will show a dose response when SOTYKTU didn't?

If you actually look at the Phase I data -- I'm assuming you're talking about ESK-001?

Yes.

Okay. When you actually look at the Phase I data, we have a linear dose response in Phase I with very little overlap. Our percent CV for that molecule is less than 20% on almost every parameter, and that is not the case for SOTYKTU. SOTYKTU has a lot of overlap in their PK. And then the other piece is we do believe that the -- when you look at the inhibition level, we actually have very consistent inhibition levels as well, which might be different with SOTYKTU. So if you ask me specifically why those 2, that's probably the issue. And when you look ultimately at the Phase I data, they did have to dose reduce for Phase II and beyond just because of some of the tolerability issues that they had, and we did not have those same tolerability issues, and we're able to dose all the way to maximal target inhibition.

Our next question comes from the line of Terence Flynn with Morgan Stanley.

I was just wondering if this impacts at all how you think about the commercial build and rollout there, if this would allow you to pull forward any of the planning ahead of a potential launch for the TYK2?

Thank you, Terence. I don't think it's going to accelerate the launch per se. It gives us maybe a little bit more flexibility in the build, but we have a very judicious build plan that we want to make sure that we have the right resources now that are stage appropriate, and we will continue to pursue that plan until we have the data from the Phase III and then decide how we best move forward from there.

Our next question comes from the line of Yatin Suneja with Guggenheim. Our next question will come from the line of Yasmeen Rahimi with Piper Sandler.

Thank you for the update. And obviously, we, as analysts, were really much rooting forward and voting for lonigutamab to enter Phase III. So definitely a surprise for us with this announcement. But I guess, team, I know you guys are going through the process to evaluate lonigutamab space, but could you maybe talk about if you end up not pursuing forward Phase III if the current cash position allows you to really diversify with the portfolio with additional assets. So I would love to hear your thoughts on if you don't move forward with that, what the use of the proceeds would be long term, whether it would be towards the TYK2 programs and pipeline enrichments or potentially evaluating additional assets that could be complementary to the current portfolio?

So I would say the cash -- the first priority for all of us is to advance the programs that we have, and that includes what we have from the Alumis side and lonigutamab. And then there certainly is opportunity within some of those molecules. As you know, there's a lot of opportunity around TYK2 and a broad opportunity for TYK2s in multiple indications. But we always are looking for additional assets on the outside that would make sense. So I wouldn't exclude it, but that is not the focus that we have. At this point, our focus is execution on the TYK2 programs and really understanding how we can advance lonigutamab and make sure that we have a capital-efficient way to show a competitive differentiated profile.

Our next question comes from Yatin Suneja with Guggenheim.

Let me add my congratulations as well. Sorry, my phone dropped out there. Two questions for me. I am not very familiar with Acelyrin pipeline. Is there anything else that they have early in the pipeline that maybe it's a little bit earlier in the stage, in the preclinical side? So that's one. Number two, with regard to the enrollment, I mean, now that you have all this cash, like what you could do to sort of further accelerate the enrollment in the psoriasis program? Because as you mentioned earlier, definitely, some of the other companies are seeing faster enrollment and now being well capitalized, there should be some venues to further accelerate that process.

This is Mina. Maybe I'll take the first question just on Acelyrin's pipeline. So we had previously announced that we were pivoting, right, to focus on lonigutamab, and we made that decision late last year, right? And we did recently announce that we were going to be winding down all of our internal efforts around izokibep. And so the program that we will be moving over to Alumis will be lonigutamab.

Yes. And in terms of acceleration, we certainly have a strong effort ongoing on making sure that we can enroll this trial fast. I would say in terms of our -- where we are at this point, we will continue to look at additional ways to accelerate, but the capital piece is not the most essential one in that.

Our next question comes from the line of Brian Skorney with Baird.

Just I wanted to get thoughts on your perception of the thyroid eye disease market. Obviously, Tepezza had a really fantastic launch, but it's sort of backed off peak sales and has been relatively stagnant, just south of $2 billion. Do you see this as an issue with Tepezza? Or do you see this with U.S. thyroid eye disease market? Or is there potential for growth? And I know there's also concerns that most of these patients really only need one cycle of injections. How do you kind of think about the sizing of that thyroid eye disease market overall?

This is Mina. Maybe I'll take that one, and then I can start and if Martin has anything to add. I mean, look, we think that there is significant unmet need in thyroid eye disease and Tepezza was, I think, a real breakthrough for patients, right, and has been an amazing therapy. But as it's kind of gone into the market, we also know that there is significant unmet need. And one of the things that we have been very excited about with lonigutamab is it has shown sort of IV-like efficacy, right, in line with the standard of care, but also a potential for a differentiated safety profile in a very easy-to-use 1ml sort of auto-injector format. And we think that, that has the potential to really expand the addressable population, right? And especially with the possibility of chronic dosing, we think that there is a significant unmet need that loni addresses.

Yes. Brian, I would just want to add, we do believe that actually there is market segments that are not appropriately addressed today that you could expand into, as Mina just said. And we actually just brought on board our Chief Commercial Officer, who is very familiar with Tepezza. And so we will certainly spend additional time to think through very carefully on the commercial side, which segments did you want to go after and how to best do that.

Our next question comes from the line of Mitchell Kapoor with H.C. Wainwright.

This is Dan on for Mitchell. Congratulations on the announcement. We were wondering what kind of synergies do you expect to see from your combined development team at this point? And how much crossover is there between TED and more classical I&I diseases?

So the synergies here, at least early on will not come from the development because we continue developing all these products. So I think where there will be synergies is probably from combining 2 companies and not needing basically 2 infrastructure for public companies. I think we should focus more on the opportunity set that we're able to pursue because we have 3 products in the pipeline, and we will certainly pursue very aggressively the 2 that have a clear path. And then the third one we'll evaluate and come back to you later on how we move forward. For us, this is about basically enhancing the pipeline and setting ourselves up on very solid financial footing to read out through all the milestones, and that's really what we're focused on.

Awesome. And if I could just follow up...

Maybe just to your second question, at the end of the day, these are all immune-mediated diseases, and we do believe that actually having a good understanding of the immune system will help, and we certainly are bringing together 2 teams that have a very good understanding of many of those diseases.

Awesome. And if I can ask a follow-up, I think this kind of tags on the questions Eric was asking. I think it was Eric. Regarding modeling, how should we expect operating expenses to develop both before the transaction closes as well as after that? I know we're looking at a capital or an intelligent capital utilization strategy.

So we touched on that a bit earlier. We'll be able to share more of that when the S-4 is available. I think we mentioned that both companies would, prior to closing, operate independently with an eye on controlling being efficient with their costs, but we will have a better idea on the -- at closing of what we can share with you in terms of the burn after that. I think you can do some math on what that is considering we've guided cash into 2027, supporting all of the Alumis programs, the 2 ongoing Phase III psoriasis trials, the ongoing Phase IIb for lupus SLE and that those are carried through readout.

I'm showing no further questions at this time. I'd like to turn the call back to Martin Babler for closing remarks.

Thank you so much. So thanks again for participating in today's call. We're excited about this merger of Acelyrin and Alumis as it will strengthen our financial position, our portfolio and sets us up very strongly for upcoming milestones and for the future. I want to thank you, and have a great day.

This concludes today's conference call. Thank you for participating. You may now disconnect.