NASDAQ:AMLX Amylyx Pharmaceuticals Q2 2024 Earnings Report $13.58 0.00 (0.00%) Closing price 05/22/2026 04:00 PM EasternExtended Trading$13.49 -0.09 (-0.66%) As of 05/22/2026 06:49 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Massive. Learn more. ProfileEarnings HistoryForecast Amylyx Pharmaceuticals EPS ResultsActual EPS-$0.73Consensus EPS -$0.38Beat/MissMissed by -$0.35One Year Ago EPS$0.31Amylyx Pharmaceuticals Revenue ResultsActual Revenue($1.02) millionExpected Revenue$18.83 millionBeat/MissMissed by -$19.85 millionYoY Revenue GrowthN/AAmylyx Pharmaceuticals Announcement DetailsQuarterQ2 2024Date8/8/2024TimeBefore Market OpensConference Call DateThursday, August 8, 2024Conference Call Time8:00AM ETUpcoming EarningsAmylyx Pharmaceuticals' Q2 2026 earnings is estimated for Thursday, August 6, 2026, based on past reporting schedules, with a conference call scheduled at 8:00 AM ET. Check back for transcripts, audio, and key financial metrics as they become available.Conference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfilePowered by Amylyx Pharmaceuticals Q2 2024 Earnings Call TranscriptProvided by QuartrAugust 8, 2024 ShareLink copied to clipboard.Key Takeaways Amelix acquired Avexitide in Q3, expanding its late-stage pipeline to three orphan-indication assets including a Phase 3 ready GLP-1 receptor antagonist. Avexitide has demonstrated >50% reductions in Level 1–3 hypoglycemic events in Phase II trials and received FDA breakthrough therapy designation, with an agreed Phase 3 PBH study set to start in Q1 2025. Following restructuring, the company ended Q2 with $309.8 million in cash and investments and projects its cash runway into 2026 to fund key trials. Amelix reported a Q2 net loss of $72.7 million ($1.07 per share), including $22.9 million in restructuring charges, and negative product revenue due to discontinued sales adjustments. The company’s pipeline also includes AMX-35 programs in Wolfram syndrome and PSP, with interim data expected mid-2025, and AMX-114 in ALS slated for clinical testing by year-end. AI Generated. May Contain Errors.Conference Call Audio Live Call not available Earnings Conference CallAmylyx Pharmaceuticals Q2 202400:00 / 00:00Speed:1x1.25x1.5x2xTranscript SectionsPresentationParticipantsPresentationSkip to Participants Operator00:00:00Good morning. My name is Camille, and I will be your conference operator for today. At this time, I would like to welcome everyone to the Amylyx Pharmaceuticals second quarter 2024 earnings conference call. All participants will be on a listen-only mode. After today's presentation, there will be an opportunity to ask questions. To ask a question, please press star one on your telephone keypad. To withdraw your question, please press star two. Please limit your questions to one with one follow-up. If you have additional questions, you may rejoin the queue. Please be advised that this call is being recorded at the company's request. I would now like to turn the call over to Lindsey Allen, Head, Investor Relations and Communications. Please proceed. Lindsey AllenHead of Investor Relations at Amylyx Pharmaceuticals00:00:50Good morning, and thank you all for joining us today to discuss our second quarter 2024 financial results. With me on the call today are Josh Cohen and Justin Klee, our co-CEOs; Dr. Camille Bedrosian, our Chief Medical Officer; and Jim Frates, our Chief Financial Officer. Before we begin, I would like to remind everyone that any statements we make or information presented on this call that are not historical facts are forward-looking statements that are 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 1995. These statements include, but are not limited to, our expectations with respect to Avexitide, AMX0035, and AMX0114, statements regarding regulatory and clinical developments and the impact thereof, and the expected timing thereof, and statements regarding our cash runway. Lindsey AllenHead of Investor Relations at Amylyx Pharmaceuticals00:01:51Actual events and results could differ materially from those expressed or implied by any forward-looking statements. You are cautioned not to place any undue reliance on these forward-looking statements, and Amylyx disclaims any obligation to update such statements unless required by law. Now, I will turn the call over to Justin. Justin KleeCEO at Amylyx Pharmaceuticals00:02:11Good morning, and thank you all for joining us today. As an organization, we have made significant progress over the past few months as part of our continued mission and our goal to deliver important treatment options to the neurodegenerative, neuroendocrine, and endocrine communities we serve. Most notably, last month, we expanded our late-stage pipeline with our acquisition of Avexitide and now have three assets targeting orphan indications. Avexitide is a phase III-ready asset with FDA breakthrough therapy designation in diseases with no approved treatment options. Avexitide is a GLP-1 receptor antagonist with orphan drug designation in hyperinsulinemic hypoglycemia. The GLP-1 receptor is one of the key regulators of the glucose-insulin response, and an imbalance in this response leads to hyperinsulinemic hypoglycemia, which underlies several conditions and diseases. So far, Avexitide has been studied in two indications characterized by hyperinsulinemic hypoglycemia: post-bariatric hypoglycemia, or PBH, and congenital hyperinsulinism. Justin KleeCEO at Amylyx Pharmaceuticals00:03:24The first indication, PBH, is a significant but orphan condition that affects a subpopulation of people who have undergone bariatric surgery. Now, let me elaborate a little further on the market opportunity ahead. Despite the introduction of GLP-1 receptor agonists for weight loss, more than 200,000 new bariatric procedures are performed every year, and this number has continued to grow on an annual basis. Over the past 10 years, approximately 2 million people in the United States have undergone the two most common types for weight loss: Roux-en-Y gastric bypass and sleeve gastrectomy. Experts expect surgery to remain a cornerstone of weight loss therapy, given the procedure is highly effective and results in substantial and sustained weight loss, particularly for people with higher BMIs. Evidence also suggests that bariatric surgery reduces the risk of cardiovascular events and the severity of metabolic dysfunction associated with liver disease. Justin KleeCEO at Amylyx Pharmaceuticals00:04:26Turning to PBH, this persistent condition can develop in people who had received bariatric surgery 1-3 years prior, and in some cases, even longer post-surgery. We estimate that approximately 8% of the 2 million people I referenced, or 160,000 people in the U.S. today, have symptomatic PBH. Symptomatic PBH is characterized by hypoglycemic events associated with brain glucose starvation, known as neuroglycopenia, including impaired cognition, loss of consciousness, and seizures, as well as activation of the autonomic nervous system, presenting as hunger, sweating, tingling, tremors, palpitations, and anxiety. People living with PBH could benefit from a treatment that helps stabilize glucose levels, particularly the dangerously low crashes in blood glucose associated with PBH. Camille will discuss our plans for the phase III development program for Avexitide, which we expect to initiate in the first quarter of next year. Justin KleeCEO at Amylyx Pharmaceuticals00:05:31There is agreement with FDA on the primary outcome for the pivotal phase III study for PBH. The outcome, reduction in the composite of level 2 and level 3 hypoglycemia events, is clearly linked to GLP-1 receptor antagonism and was already met in the phase II and phase IIB clinical trials of Avexitide in PBH with high significance. Camille will also recap the key data, including the statistically significant and clinically meaningful reductions in hypoglycemic events.... We are highly encouraged by the greater than 50% reductions in level 1, 2, and 3 hypoglycemic events that have been demonstrated by Avexitide. Avexitide has the potential to be the first-in-class GLP-1 receptor antagonist. Before I turn it over to Camille, I would like to quickly touch on our cash runway. In the second quarter, we largely completed our restructuring. We expect our cash runway to take us into 2026. Justin KleeCEO at Amylyx Pharmaceuticals00:06:33Jim will provide additional context. I will now turn the call over to Camille. Camille BedrosianChief Medical Officer at Amylyx Pharmaceuticals00:06:40Thanks, Justin. Now, I will briefly review each of our four programs. Avexitide and hyperinsulinemic hypoglycemia, including post-bariatric hypoglycemia or PBH, AMX0035 in Wolfram syndrome and in progressive supranuclear palsy, or PSP, and AMX0114 in ALS. Avexitide is designed to bind to the GLP-1 receptor on pancreatic islet beta cells and block the effect of GLP-1 to mitigate hypoglycemia by decreasing insulin secretion and stabilizing glucose levels. Avexitide has been studied in five clinical trials in PBH. Data from these trials demonstrated highly significant reductions in hypoglycemic events. Camille BedrosianChief Medical Officer at Amylyx Pharmaceuticals00:07:29Most notably, the 90-milligram dose, which we intend to study in phase III, showed a 66% reduction in level 3 hypoglycemic events in a phase IIB trial, with a P value of 0.0003, and a 53% reduction in level 2 hypoglycemic events, with a P value of 0.004. The primary efficacy outcome of our phase III program will be the reduction in the composite of level 2 and level 3 hypoglycemic events. The FDA has agreed on this primary efficacy outcome. Furthermore, these data were achieved while demonstrating a favorable safety profile. The benefit of Avexitide is further supported by 4 additional trials in PBH, which reproducibly showed glucose stabilization and decreased insulin levels with statistically significant P values. We reviewed these data in depth during our conference call last month. Camille BedrosianChief Medical Officer at Amylyx Pharmaceuticals00:08:34Based on these data, we are actively planning and are on track to initiate a pivotal phase III program in PBH in Q1 of next year. For those of you who are not familiar with PBH, the condition affects people who have undergone bariatric surgery. Symptomatic PBH can have disabling effects on quality of life and ability to live independently, especially the neuroglycopenic symptoms. Imagine you are driving and your blood sugar drops without you realizing it, and you have a seizure. As a result, your license could be suspended, or because you could potentially faint and lose consciousness at any time, you have to move in with a friend or relative so they can provide immediate assistance or call 911 if you fall and injure yourself. Imagine being forced to retire mid-career because you have impaired cognition due to sustained low glucose. Camille BedrosianChief Medical Officer at Amylyx Pharmaceuticals00:09:37These examples are experiences that individuals living with PBH have shared. This is a reality for the 160,000 people that we estimate are currently living with symptomatic PBH. These individuals could benefit from a therapy that might mitigate unexpected or current drops in blood glucose, which can create very problematic health, social, and economic issues, despite their best efforts with dietary modifications and off-label use of other medications. We believe the significant unmet need, coupled with the robust Avexitide clinical data in PBH, contribute to the excitement about our PBH program among endocrinologists. We will work to enroll participants in our phase III program as promptly as possible, such that we will be in a position to share top-line data from the program in 2026. Now, turning to the Wolfram syndrome program. Camille BedrosianChief Medical Officer at Amylyx Pharmaceuticals00:10:39We look forward to presenting the top-line data for all 12 participants in the HELIOS trial at week 24, including longer-term data available for participants who have reached their week 36 or week 48 visit at that time at the International Society for Pediatric and Adolescent Diabetes Conference this fall. We are engaging with stakeholders, including the FDA, and planning for a single phase III clinical trial, and we'll provide more details once finalized. As a reminder, AMX0035 has shown highly significant benefits in glycemic control in the in vivo WFS1 knockout mouse model of Wolfram syndrome. These glycemic results were recapitulated and extended in our clinical trial of Wolfram, including promising data on glycemic, as well as optic and global impressions of change outcomes presented in April. Recall that Wolfram syndrome is a progressive neurodegenerative disease. Camille BedrosianChief Medical Officer at Amylyx Pharmaceuticals00:11:45While we had anticipated slowing of this progression, in fact, the data suggested stabilization or even improvement across these outcomes. Now, turning to the ORION PSP program. Enrollment in the study is going well. As we have described previously, we intend to conduct an interim analysis of ORION and share data in mid-2025. I would like to describe the planned analysis in a bit more detail. We have introduced an operationally seamless phase IIb/III study design. The first part will include approximately 100 people living with PSP. Mid-2025, we plan to conduct an unblinded analysis of top-line data through week 24 for these participants. In addition, the available data on participants who have proceeded beyond 24 weeks also will be analyzed. The goal of this analysis is to inform a go, no-go decision. Camille BedrosianChief Medical Officer at Amylyx Pharmaceuticals00:12:45Strong data will encourage us to move seamlessly into the second portion of the study, whereas mixed or negative data will allow us to reprioritize our resources. As a reminder, AMX0035 has shown highly significant reductions of tau and CSF in a randomized, placebo-controlled study in Alzheimer's disease. As we have previously discussed, PSP is a tauopathy with a highly significant genetic link between variants in tau and the disease, and with clear tau pathology in human samples. AMX0035 is believed to affect intracellular tau, and we believe it is the first agent to be studied in a large trial with the potential to impact intracellular tau pathology. Finally, our AMX0114 program remains on track. We plan to begin clinical testing before the end of the year. Camille BedrosianChief Medical Officer at Amylyx Pharmaceuticals00:13:45AMX0114 is an antisense oligonucleotide, or ASO, designed specifically to inhibit calpain 2, a protein involved in axonal degeneration and neurofilament biology. We are planning to study this agent in a multiple ascending-dose, placebo-controlled study in ALS to evaluate the safety and the biological activity of AMX0114. At Amylyx, our goal is to significantly impact diseases of unmet need, and with these four programs, we believe we are on track to do so. I will now turn over the call to Jim. Jim? Jim FratesCFO at Amylyx Pharmaceuticals00:14:26Thanks, Camille. Following PHOENIX top-line results, we restructured quickly, which placed us in a strong cash position and enabled us to focus on our meaningful near-term clinical milestones. We ended Q2 with $309.8 million in cash and investments. As a reminder, we acquired Avexitide in early Q3 for a purchase price of $35.1 million. Since the acquisition, we have targeted our budget to focus on our major clinical programs. As a result of this work, we believe our cash will take us into 2026, and we will work to manage the company through meaningful clinical data readouts, namely, the data readout from our phase II HELIOS trial in Wolfram syndrome, the interim readout from our PSP program, interim clinical data from our AMX114 program, and the readout of top-line data from the Avexitide phase III program. Jim FratesCFO at Amylyx Pharmaceuticals00:15:22Now, turning to other details of our financial results. Net product revenue was -$1 million for the second quarter due to adjustments to our gross to net revenue reserve estimates. This was mainly driven by adjustments to our estimates for returns once we stopped our sales. Cost of sales were $7.4 million for Q2, compared to $5.6 million for the same period in 2023. Cost of sales this quarter were primarily related to estimated losses on firm commitments under commercial manufacturing and supply agreements for RELIVRIO and ALBRIOZA that were established for future production prior to the results from PHOENIX. We do not expect any material COGS moving forward. Research and development expenses were $23.3 million for the quarter, compared to $29 million for the same period in 2023. Jim FratesCFO at Amylyx Pharmaceuticals00:16:15The decrease was primarily due to a decline in payroll and personnel-related costs as a result of our restructuring and a decrease in clinical expense due to the outcome of the PHOENIX trial. Selling, general, and administrative expenses were $21.6 million for Q2, compared to $43.4 million for the same period in 2023. The decrease was primarily due to a decline in payroll and personnel-related costs and a decrease in consulting and professional services following our decision to voluntarily discontinue the marketing of RELIVRIO and ALBRIOZA. Restructuring expense was $22.9 million in the quarter, compared to 0 for the same period in 2023. The majority of this charge is related to employee severance and termination-related benefits that were paid in Q2, and our restructuring plan was largely completed this quarter. Jim FratesCFO at Amylyx Pharmaceuticals00:17:10Consistent with our prior expectations as we move into 2025, we expect total combined spend on R&D and SG&A will be in the range of $30 million-$40 million in cash per quarter. Finally, in the second quarter, we recorded a net loss of $72.7 million, or $1.07 per share, including the restructuring charges. Overall, we're in a solid financial position and believe in our ability to deliver on the clinical milestones that we outlined today. I'll now turn the call over to Josh to provide some closing remarks. Josh CohenCEO at Amylyx Pharmaceuticals00:17:45Thank you, Jim. In closing, we are excited about our four pipeline programs, upcoming milestones, and path ahead. Avexitide has both FDA Breakthrough Therapy designation and Orphan Drug Designation, and is poised to advance into phase III development in PBH, beginning in the first quarter of 2025. In Wolfram syndrome, we expect the top-line data from HELIOS in the fall for all 12 participants at week 24. Josh CohenCEO at Amylyx Pharmaceuticals00:18:16... including longer-term data available for participants who have reached their week 36 or 48 visit at that time. We are engaging the FDA and other stakeholders and planning for a single phase III clinical trial. We will provide more details on the trial once the design is finalized. The ORION trial of AMX0035 and PSP is recruiting well, and we continue to expect data from an interim analysis mid-next year. AMX114 is on track to be studied in people living with ALS later this year. And we believe we have the team and resources in place to deliver on 4 meaningful clinical data readouts ahead. We look forward to keeping you updated as we build upon our critical work in orphan neurodegenerative, neuroendocrine, and endocrine diseases of high unmet need. Now, I would like to open the call up for Q&A. Operator00:19:15Thank you. We will now begin the Q&A session. To ask a question, please press star one on your telephone keypad. To withdraw your question, press the pound key or star two. Please limit your question to one with one follow-up. If you have additional questions, you may rejoin the queue. At this time, we will pause momentarily to assemble our roster. Your first question comes from the line of Charlie Yang from Bank of America. Please go ahead. Charlie YangSenior Equity Research Analyst of Biotech and Pharma at Bank of America00:19:55Great. Thanks for taking my questions. I just wanted to ask about the, the PSP, you know, data in mid-next year in terms of the, kind of the expectation over there. And then, you know, I'm assuming if there's a signal observed, you know, is there, I guess, is there a path to make an adjustment to a number of patients as needed to further kind of amplify the potential success of this trial, at, at the final readout? Camille BedrosianChief Medical Officer at Amylyx Pharmaceuticals00:20:23Yep. Thank you, Charlie. This is Camille. As we indicated in our prepared remarks, we will. The first part of the study is a phase IIB, where we will analyze about 100 participants, unblinded, of AMX0035 versus placebo, and do a full-on analysis at 24 weeks. And for those who have gone beyond 24 weeks, to look at their longer-term data as well. And based on that result, we will then, if positive and strong, we will proceed seamlessly into the phase III portion of the study. And based on those data, the final sample size will be determined. Charlie YangSenior Equity Research Analyst of Biotech and Pharma at Bank of America00:21:08Great, thanks. Maybe just one quick follow-up, just in terms of the Wolfram opportunity in Europe, how does that kind of compare to the U.S.? Thank you. Camille BedrosianChief Medical Officer at Amylyx Pharmaceuticals00:21:18Yes. So we are certainly aware of endocrinologists who are familiar with Wolfram and have a large, large, relatively speaking, Wolfram population. So, but right now we are focusing on the U.S. and, so we do... Yeah. So, more to come on that as we do more research. Josh CohenCEO at Amylyx Pharmaceuticals00:21:39I would add that, you know, Wolfram being a monogenic disease, we do see people with Wolfram syndrome all around the world. Camille BedrosianChief Medical Officer at Amylyx Pharmaceuticals00:21:47Yes. Josh CohenCEO at Amylyx Pharmaceuticals00:21:48So it is very much a global unmet need. Operator00:21:55Thank you. Your next question comes from the line of Corinne Jenkins from Goldman. Please go ahead. Palak JhajhariaEquity Research Associate at Goldman00:22:05Hi, good morning. This is Palak on for Corinne. Two from us on the PSP front. The first being, what do prior studies in PSP suggest for placebo and natural history population at the 24-week time point? And then the second was, what are you thinking about in terms of the threshold for futility at the 24-week endpoint in the interim analysis? Thank you. Camille BedrosianChief Medical Officer at Amylyx Pharmaceuticals00:22:27Yep. So, as you are alluding, in fact, the progression of the disease is actually quite reproducible. There were 3 relatively large phase III studies in PSP, unfortunately, none of which showed a benefit of the active drug, but it did show that there was reproducible deterioration at a relatively similar rate. So we do use that as a basis for understanding and looking at the data coming out. Josh CohenCEO at Amylyx Pharmaceuticals00:23:04And, you know, as your other question, too, on the threshold for futility, this is not a, you know, formal futility analysis. We're doing a full evaluation of the data, so we'll be looking at, you know, kind of a full top-line release, you know, essentially a phase IIB release, when we do that interim analysis. And just, you know, highlighting, Camille's point as well, when you look, at the past, you know, larger randomized placebo-controlled studies that have been conducted in PSP, the placebo rate is actually, you know, quite strikingly consistent, you know, usually at just under a point a month. Palak JhajhariaEquity Research Associate at Goldman00:23:40Understood. Thank you. Operator00:23:43Thank you. Your next question comes from the line of Umer Raffat from Maverick Capital. Please go ahead. Xiang ChenFinancial Analyst at Thrive Alternatives Capital Advisory00:23:51Hi, good morning. This is Chen Xiang on for Umar. Thanks for taking our questions. I guess, firstly, for Wolfram syndrome phase III trial, does it need to be placebo-controlled? And secondly, for AMX0114, are you planning to give incremental data update as it progresses, maybe the timing between phase II Wolfram trial data this fall and the phase III PSP interim next year? Camille BedrosianChief Medical Officer at Amylyx Pharmaceuticals00:24:13Right. So thank you for the questions. This is Camille. Regarding Wolfram, as we indicated in our prepared remarks, we are engaging with stakeholders that include, of course, the FDA, and once our plans are finalized, we'll share those with you. Just as a reminder, later this fall, we will share data on all 12 participants through 24 weeks, and additional longer-term data for those individuals who have gone through week 36 and 48. So we're looking forward to those readouts as well. And then regarding zero one one four, as we indicated, we are planning to initiate our multiple ascending dose study in individuals with ALS by the end of the year. And as the study progresses, we'll be able to provide more detailed timing and types of data we'll be sharing through 2025. Xiang ChenFinancial Analyst at Thrive Alternatives Capital Advisory00:25:12Thank you. Operator00:25:15Thank you. Your next question comes from the line of Graig Suvannavejh from Mizuho Financial Group. Please go ahead. Charles YangDirector of Project Management at Mizuho Financial Group00:25:25Good morning, everyone. This is Charles Yang in for Greg. Thanks for taking our question. We were wondering, what type of data will you present at the updated data presentation for HELIOS? Should we expect it to be similar to the interim readout earlier this year? Thanks. Camille BedrosianChief Medical Officer at Amylyx Pharmaceuticals00:25:39Yep, thank you. This is Camille again. Indeed, so we do intend to provide longer-term data for those individuals about whom we reported in April of this year, as well as data through 24 weeks for all 12 participants. It's top line data, primary endpoint, and key secondary endpoints, and we look forward to sharing those details with you at the upcoming international meeting. Operator00:26:05Thank you, Greg. Your next question comes from the line of Marc Goodman from Leerink Partners. Please go ahead. Rudy LiEquity Research Analyst at Leerink Partners00:26:28Hi, thanks for taking my question. This is Rudy on the line for Mark. Can you talk about R&D expenses going into 2025? What is your strategy to build the pipeline going forward with both internal and external assets? Thanks. Jim FratesCFO at Amylyx Pharmaceuticals00:26:46Yeah, thank you. It's Jim. Good morning. I think one of the things that is happening on our R&D line, right? As our restructuring has occurred, and as the large Phoenix phase III winds down, and you can find some detail on those expenses historically in our Qs. That really opens up room for some of the new spending that we have going on. And, you know, currently the Wolfram study is ongoing. The PSP study is starting to move up into a range where that, you know, that's gonna be consistent as opposed to really growing. And so that leaves us room as we move forward, to spend on the 114 study and the new Avexitide program. Jim FratesCFO at Amylyx Pharmaceuticals00:27:26Then just overall, as we outlined, we expect cash expense, now that's excluding non-cash comp, to be in the range of $30 million-$40 million a quarter for both R&D and SG&A. So that's how some of the moving parts are going into 2025. Rudy LiEquity Research Analyst at Leerink Partners00:27:42Very helpful. Thanks. Jim FratesCFO at Amylyx Pharmaceuticals00:27:44You're welcome. Operator00:27:47Thank you. Your next question comes from the line of Joel Beatty from Baird. Please go ahead. Joel BeattyBiotechnology Equity Research Analyst at Baird00:27:56Hi, thanks for taking the questions. For the PSP interim analysis, to get data around mid-2025, does that mean completing enrollment around the end of this year? And what gives you confidence on the trial completing enrollment around that timeframe? Camille BedrosianChief Medical Officer at Amylyx Pharmaceuticals00:28:13Yes. Hi, Joel, this is Camille. We are enrolling quite well, as I indicated in our prepared remarks, and we're tracking toward having data mid-2025. We'll give more information as we march toward that timeframe. Joel BeattyBiotechnology Equity Research Analyst at Baird00:28:29Great. And then, as a follow-up, do you anticipate any more acquisitions after the recent acquisition of Avexitide? Justin KleeCEO at Amylyx Pharmaceuticals00:28:38Yeah. You know, I'll say we wouldn't. You know, we've had a process ongoing for some time, where we're evaluating, you know, many assets for, you know, that, you know, whether they fit well into our pipeline and have the requisite, you know, scientific and clinical and commercial, you know, path forward. Today, we're very excited about the assets we, you know, have today, and that's our focus. But, you know, we're always looking, and I, I'd say we wouldn't rule out, you know, adding additional things in. Joel BeattyBiotechnology Equity Research Analyst at Baird00:29:10Thank you. Operator00:29:11Thank you. There are no further questions at this time. I'll turn the call back to Mr. Klee. Justin KleeCEO at Amylyx Pharmaceuticals00:29:18Thank you for joining us today on today's call to discuss our second quarter 2024 financial results. Have a great day. Operator00:29:31Thank you for joining today's call. Please disconnect your line. Thank you.Read moreParticipantsExecutivesCamille BedrosianChief Medical OfficerJim FratesCFOJosh CohenCEOJustin KleeCEOLindsey AllenHead of Investor RelationsAnalystsCharles YangDirector of Project Management at Mizuho Financial GroupCharlie YangSenior Equity Research Analyst of Biotech and Pharma at Bank of AmericaJoel BeattyBiotechnology Equity Research Analyst at BairdPalak JhajhariaEquity Research Associate at GoldmanRudy LiEquity Research Analyst at Leerink PartnersXiang ChenFinancial Analyst at Thrive Alternatives Capital AdvisoryPowered by Earnings DocumentsPress Release(8-K)Quarterly report(10-Q) Amylyx Pharmaceuticals Earnings HeadlinesAmylyx Pharmaceuticals, Inc. (AMLX) Reports Q1 2026 Results and Pipeline ProgressMay 20, 2026 | insidermonkey.comAmylyx Pharmaceuticals Announces Peer-Reviewed Publication of Phase 2 Open-Label HELIOS Trial Data for AMX0035 in The Journal of Clinical InvestigationMay 15, 2026 | businesswire.comYour $29.97 book is free todayWhy Some Traders Skip Stocks Entirely You don't need a big account to trade options. In fact, options can give you up to 12 times the leverage of stocks — with a fraction of the capital tied up. This free guide lays it all out in plain English — from A to Z, with step-by-step examples you can follow in your own account.May 25 at 1:00 AM | Profits Run (Ad)Amylyx Pharmaceuticals, Inc. (AMLX) Presents at Bank of America Global Healthcare Conference 2026 TranscriptMay 13, 2026 | seekingalpha.comAmylyx Pharmaceuticals Charts Path to 2026 Trial DataMay 8, 2026 | tipranks.comAmylyx Pharmaceuticals, Inc. ($AMLX) Co-CEO and Director 2025 Pay RevealedApril 23, 2026 | quiverquant.comQSee More Amylyx Pharmaceuticals Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Amylyx Pharmaceuticals? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Amylyx Pharmaceuticals and other key companies, straight to your email. Email Address About Amylyx PharmaceuticalsAmylyx Pharmaceuticals (NASDAQ:AMLX) is a biopharmaceutical company dedicated to developing treatments for rare and debilitating neurological diseases. Founded in 2013 and headquartered in Cambridge, Massachusetts, the company focuses on leveraging novel approaches to target cellular pathways implicated in neurodegeneration. Amylyx’s research platform centers on small-molecule therapies designed to protect neurons and support cellular health in patients with conditions that currently have limited or no disease-modifying treatment options. The company’s lead product, AMX0035, is marketed under the trade name Relyvrio following U.S. Food and Drug Administration approval in 2022 for the treatment of amyotrophic lateral sclerosis (ALS). Amylyx has also filed for regulatory approval of AMX0035 (known as Albrioza) in the European Union and continues to explore its potential utility in other neurodegenerative disorders. In addition to ALS, the Amylyx pipeline includes early-stage programs investigating therapies for Alzheimer’s disease and GM1 gangliosidosis, reflecting the company’s broader commitment to addressing central nervous system pathologies. Amylyx operates primarily in North America and is advancing its global development and commercialization capabilities through strategic collaborations and regulatory engagements. Under the leadership of Chief Executive Officer John H. Johnson III, the company continues to expand clinical development efforts and strengthen its manufacturing and distribution networks. Amylyx’s multidisciplinary team of scientists, clinicians and regulatory experts works to translate preclinical discoveries into potential therapies for patients facing critical neurological challenges.View Amylyx Pharmaceuticals ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Latest Articles Ross Stores Earnings Beat Sends Stock To New HighsWas Decker’s Double Beat a Bullish Signal—Or Mere HOKA’s-Pocus?Workday Validates AI Flywheel: Stock Price Recovery BeginsApparel Earnings Winners and Losers: Ralph Lauren Takes OffWhy Walmart, Target and TJX Got Such Different Reactions After EarningsThe Careful Consumer: What Q1 Earnings Reveal—And Where Cracks May AppearOverextended, e.l.f. 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PresentationSkip to Participants Operator00:00:00Good morning. My name is Camille, and I will be your conference operator for today. At this time, I would like to welcome everyone to the Amylyx Pharmaceuticals second quarter 2024 earnings conference call. All participants will be on a listen-only mode. After today's presentation, there will be an opportunity to ask questions. To ask a question, please press star one on your telephone keypad. To withdraw your question, please press star two. Please limit your questions to one with one follow-up. If you have additional questions, you may rejoin the queue. Please be advised that this call is being recorded at the company's request. I would now like to turn the call over to Lindsey Allen, Head, Investor Relations and Communications. Please proceed. Lindsey AllenHead of Investor Relations at Amylyx Pharmaceuticals00:00:50Good morning, and thank you all for joining us today to discuss our second quarter 2024 financial results. With me on the call today are Josh Cohen and Justin Klee, our co-CEOs; Dr. Camille Bedrosian, our Chief Medical Officer; and Jim Frates, our Chief Financial Officer. Before we begin, I would like to remind everyone that any statements we make or information presented on this call that are not historical facts are forward-looking statements that are 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 1995. These statements include, but are not limited to, our expectations with respect to Avexitide, AMX0035, and AMX0114, statements regarding regulatory and clinical developments and the impact thereof, and the expected timing thereof, and statements regarding our cash runway. Lindsey AllenHead of Investor Relations at Amylyx Pharmaceuticals00:01:51Actual events and results could differ materially from those expressed or implied by any forward-looking statements. You are cautioned not to place any undue reliance on these forward-looking statements, and Amylyx disclaims any obligation to update such statements unless required by law. Now, I will turn the call over to Justin. Justin KleeCEO at Amylyx Pharmaceuticals00:02:11Good morning, and thank you all for joining us today. As an organization, we have made significant progress over the past few months as part of our continued mission and our goal to deliver important treatment options to the neurodegenerative, neuroendocrine, and endocrine communities we serve. Most notably, last month, we expanded our late-stage pipeline with our acquisition of Avexitide and now have three assets targeting orphan indications. Avexitide is a phase III-ready asset with FDA breakthrough therapy designation in diseases with no approved treatment options. Avexitide is a GLP-1 receptor antagonist with orphan drug designation in hyperinsulinemic hypoglycemia. The GLP-1 receptor is one of the key regulators of the glucose-insulin response, and an imbalance in this response leads to hyperinsulinemic hypoglycemia, which underlies several conditions and diseases. So far, Avexitide has been studied in two indications characterized by hyperinsulinemic hypoglycemia: post-bariatric hypoglycemia, or PBH, and congenital hyperinsulinism. Justin KleeCEO at Amylyx Pharmaceuticals00:03:24The first indication, PBH, is a significant but orphan condition that affects a subpopulation of people who have undergone bariatric surgery. Now, let me elaborate a little further on the market opportunity ahead. Despite the introduction of GLP-1 receptor agonists for weight loss, more than 200,000 new bariatric procedures are performed every year, and this number has continued to grow on an annual basis. Over the past 10 years, approximately 2 million people in the United States have undergone the two most common types for weight loss: Roux-en-Y gastric bypass and sleeve gastrectomy. Experts expect surgery to remain a cornerstone of weight loss therapy, given the procedure is highly effective and results in substantial and sustained weight loss, particularly for people with higher BMIs. Evidence also suggests that bariatric surgery reduces the risk of cardiovascular events and the severity of metabolic dysfunction associated with liver disease. Justin KleeCEO at Amylyx Pharmaceuticals00:04:26Turning to PBH, this persistent condition can develop in people who had received bariatric surgery 1-3 years prior, and in some cases, even longer post-surgery. We estimate that approximately 8% of the 2 million people I referenced, or 160,000 people in the U.S. today, have symptomatic PBH. Symptomatic PBH is characterized by hypoglycemic events associated with brain glucose starvation, known as neuroglycopenia, including impaired cognition, loss of consciousness, and seizures, as well as activation of the autonomic nervous system, presenting as hunger, sweating, tingling, tremors, palpitations, and anxiety. People living with PBH could benefit from a treatment that helps stabilize glucose levels, particularly the dangerously low crashes in blood glucose associated with PBH. Camille will discuss our plans for the phase III development program for Avexitide, which we expect to initiate in the first quarter of next year. Justin KleeCEO at Amylyx Pharmaceuticals00:05:31There is agreement with FDA on the primary outcome for the pivotal phase III study for PBH. The outcome, reduction in the composite of level 2 and level 3 hypoglycemia events, is clearly linked to GLP-1 receptor antagonism and was already met in the phase II and phase IIB clinical trials of Avexitide in PBH with high significance. Camille will also recap the key data, including the statistically significant and clinically meaningful reductions in hypoglycemic events.... We are highly encouraged by the greater than 50% reductions in level 1, 2, and 3 hypoglycemic events that have been demonstrated by Avexitide. Avexitide has the potential to be the first-in-class GLP-1 receptor antagonist. Before I turn it over to Camille, I would like to quickly touch on our cash runway. In the second quarter, we largely completed our restructuring. We expect our cash runway to take us into 2026. Justin KleeCEO at Amylyx Pharmaceuticals00:06:33Jim will provide additional context. I will now turn the call over to Camille. Camille BedrosianChief Medical Officer at Amylyx Pharmaceuticals00:06:40Thanks, Justin. Now, I will briefly review each of our four programs. Avexitide and hyperinsulinemic hypoglycemia, including post-bariatric hypoglycemia or PBH, AMX0035 in Wolfram syndrome and in progressive supranuclear palsy, or PSP, and AMX0114 in ALS. Avexitide is designed to bind to the GLP-1 receptor on pancreatic islet beta cells and block the effect of GLP-1 to mitigate hypoglycemia by decreasing insulin secretion and stabilizing glucose levels. Avexitide has been studied in five clinical trials in PBH. Data from these trials demonstrated highly significant reductions in hypoglycemic events. Camille BedrosianChief Medical Officer at Amylyx Pharmaceuticals00:07:29Most notably, the 90-milligram dose, which we intend to study in phase III, showed a 66% reduction in level 3 hypoglycemic events in a phase IIB trial, with a P value of 0.0003, and a 53% reduction in level 2 hypoglycemic events, with a P value of 0.004. The primary efficacy outcome of our phase III program will be the reduction in the composite of level 2 and level 3 hypoglycemic events. The FDA has agreed on this primary efficacy outcome. Furthermore, these data were achieved while demonstrating a favorable safety profile. The benefit of Avexitide is further supported by 4 additional trials in PBH, which reproducibly showed glucose stabilization and decreased insulin levels with statistically significant P values. We reviewed these data in depth during our conference call last month. Camille BedrosianChief Medical Officer at Amylyx Pharmaceuticals00:08:34Based on these data, we are actively planning and are on track to initiate a pivotal phase III program in PBH in Q1 of next year. For those of you who are not familiar with PBH, the condition affects people who have undergone bariatric surgery. Symptomatic PBH can have disabling effects on quality of life and ability to live independently, especially the neuroglycopenic symptoms. Imagine you are driving and your blood sugar drops without you realizing it, and you have a seizure. As a result, your license could be suspended, or because you could potentially faint and lose consciousness at any time, you have to move in with a friend or relative so they can provide immediate assistance or call 911 if you fall and injure yourself. Imagine being forced to retire mid-career because you have impaired cognition due to sustained low glucose. Camille BedrosianChief Medical Officer at Amylyx Pharmaceuticals00:09:37These examples are experiences that individuals living with PBH have shared. This is a reality for the 160,000 people that we estimate are currently living with symptomatic PBH. These individuals could benefit from a therapy that might mitigate unexpected or current drops in blood glucose, which can create very problematic health, social, and economic issues, despite their best efforts with dietary modifications and off-label use of other medications. We believe the significant unmet need, coupled with the robust Avexitide clinical data in PBH, contribute to the excitement about our PBH program among endocrinologists. We will work to enroll participants in our phase III program as promptly as possible, such that we will be in a position to share top-line data from the program in 2026. Now, turning to the Wolfram syndrome program. Camille BedrosianChief Medical Officer at Amylyx Pharmaceuticals00:10:39We look forward to presenting the top-line data for all 12 participants in the HELIOS trial at week 24, including longer-term data available for participants who have reached their week 36 or week 48 visit at that time at the International Society for Pediatric and Adolescent Diabetes Conference this fall. We are engaging with stakeholders, including the FDA, and planning for a single phase III clinical trial, and we'll provide more details once finalized. As a reminder, AMX0035 has shown highly significant benefits in glycemic control in the in vivo WFS1 knockout mouse model of Wolfram syndrome. These glycemic results were recapitulated and extended in our clinical trial of Wolfram, including promising data on glycemic, as well as optic and global impressions of change outcomes presented in April. Recall that Wolfram syndrome is a progressive neurodegenerative disease. Camille BedrosianChief Medical Officer at Amylyx Pharmaceuticals00:11:45While we had anticipated slowing of this progression, in fact, the data suggested stabilization or even improvement across these outcomes. Now, turning to the ORION PSP program. Enrollment in the study is going well. As we have described previously, we intend to conduct an interim analysis of ORION and share data in mid-2025. I would like to describe the planned analysis in a bit more detail. We have introduced an operationally seamless phase IIb/III study design. The first part will include approximately 100 people living with PSP. Mid-2025, we plan to conduct an unblinded analysis of top-line data through week 24 for these participants. In addition, the available data on participants who have proceeded beyond 24 weeks also will be analyzed. The goal of this analysis is to inform a go, no-go decision. Camille BedrosianChief Medical Officer at Amylyx Pharmaceuticals00:12:45Strong data will encourage us to move seamlessly into the second portion of the study, whereas mixed or negative data will allow us to reprioritize our resources. As a reminder, AMX0035 has shown highly significant reductions of tau and CSF in a randomized, placebo-controlled study in Alzheimer's disease. As we have previously discussed, PSP is a tauopathy with a highly significant genetic link between variants in tau and the disease, and with clear tau pathology in human samples. AMX0035 is believed to affect intracellular tau, and we believe it is the first agent to be studied in a large trial with the potential to impact intracellular tau pathology. Finally, our AMX0114 program remains on track. We plan to begin clinical testing before the end of the year. Camille BedrosianChief Medical Officer at Amylyx Pharmaceuticals00:13:45AMX0114 is an antisense oligonucleotide, or ASO, designed specifically to inhibit calpain 2, a protein involved in axonal degeneration and neurofilament biology. We are planning to study this agent in a multiple ascending-dose, placebo-controlled study in ALS to evaluate the safety and the biological activity of AMX0114. At Amylyx, our goal is to significantly impact diseases of unmet need, and with these four programs, we believe we are on track to do so. I will now turn over the call to Jim. Jim? Jim FratesCFO at Amylyx Pharmaceuticals00:14:26Thanks, Camille. Following PHOENIX top-line results, we restructured quickly, which placed us in a strong cash position and enabled us to focus on our meaningful near-term clinical milestones. We ended Q2 with $309.8 million in cash and investments. As a reminder, we acquired Avexitide in early Q3 for a purchase price of $35.1 million. Since the acquisition, we have targeted our budget to focus on our major clinical programs. As a result of this work, we believe our cash will take us into 2026, and we will work to manage the company through meaningful clinical data readouts, namely, the data readout from our phase II HELIOS trial in Wolfram syndrome, the interim readout from our PSP program, interim clinical data from our AMX114 program, and the readout of top-line data from the Avexitide phase III program. Jim FratesCFO at Amylyx Pharmaceuticals00:15:22Now, turning to other details of our financial results. Net product revenue was -$1 million for the second quarter due to adjustments to our gross to net revenue reserve estimates. This was mainly driven by adjustments to our estimates for returns once we stopped our sales. Cost of sales were $7.4 million for Q2, compared to $5.6 million for the same period in 2023. Cost of sales this quarter were primarily related to estimated losses on firm commitments under commercial manufacturing and supply agreements for RELIVRIO and ALBRIOZA that were established for future production prior to the results from PHOENIX. We do not expect any material COGS moving forward. Research and development expenses were $23.3 million for the quarter, compared to $29 million for the same period in 2023. Jim FratesCFO at Amylyx Pharmaceuticals00:16:15The decrease was primarily due to a decline in payroll and personnel-related costs as a result of our restructuring and a decrease in clinical expense due to the outcome of the PHOENIX trial. Selling, general, and administrative expenses were $21.6 million for Q2, compared to $43.4 million for the same period in 2023. The decrease was primarily due to a decline in payroll and personnel-related costs and a decrease in consulting and professional services following our decision to voluntarily discontinue the marketing of RELIVRIO and ALBRIOZA. Restructuring expense was $22.9 million in the quarter, compared to 0 for the same period in 2023. The majority of this charge is related to employee severance and termination-related benefits that were paid in Q2, and our restructuring plan was largely completed this quarter. Jim FratesCFO at Amylyx Pharmaceuticals00:17:10Consistent with our prior expectations as we move into 2025, we expect total combined spend on R&D and SG&A will be in the range of $30 million-$40 million in cash per quarter. Finally, in the second quarter, we recorded a net loss of $72.7 million, or $1.07 per share, including the restructuring charges. Overall, we're in a solid financial position and believe in our ability to deliver on the clinical milestones that we outlined today. I'll now turn the call over to Josh to provide some closing remarks. Josh CohenCEO at Amylyx Pharmaceuticals00:17:45Thank you, Jim. In closing, we are excited about our four pipeline programs, upcoming milestones, and path ahead. Avexitide has both FDA Breakthrough Therapy designation and Orphan Drug Designation, and is poised to advance into phase III development in PBH, beginning in the first quarter of 2025. In Wolfram syndrome, we expect the top-line data from HELIOS in the fall for all 12 participants at week 24. Josh CohenCEO at Amylyx Pharmaceuticals00:18:16... including longer-term data available for participants who have reached their week 36 or 48 visit at that time. We are engaging the FDA and other stakeholders and planning for a single phase III clinical trial. We will provide more details on the trial once the design is finalized. The ORION trial of AMX0035 and PSP is recruiting well, and we continue to expect data from an interim analysis mid-next year. AMX114 is on track to be studied in people living with ALS later this year. And we believe we have the team and resources in place to deliver on 4 meaningful clinical data readouts ahead. We look forward to keeping you updated as we build upon our critical work in orphan neurodegenerative, neuroendocrine, and endocrine diseases of high unmet need. Now, I would like to open the call up for Q&A. Operator00:19:15Thank you. We will now begin the Q&A session. To ask a question, please press star one on your telephone keypad. To withdraw your question, press the pound key or star two. Please limit your question to one with one follow-up. If you have additional questions, you may rejoin the queue. At this time, we will pause momentarily to assemble our roster. Your first question comes from the line of Charlie Yang from Bank of America. Please go ahead. Charlie YangSenior Equity Research Analyst of Biotech and Pharma at Bank of America00:19:55Great. Thanks for taking my questions. I just wanted to ask about the, the PSP, you know, data in mid-next year in terms of the, kind of the expectation over there. And then, you know, I'm assuming if there's a signal observed, you know, is there, I guess, is there a path to make an adjustment to a number of patients as needed to further kind of amplify the potential success of this trial, at, at the final readout? Camille BedrosianChief Medical Officer at Amylyx Pharmaceuticals00:20:23Yep. Thank you, Charlie. This is Camille. As we indicated in our prepared remarks, we will. The first part of the study is a phase IIB, where we will analyze about 100 participants, unblinded, of AMX0035 versus placebo, and do a full-on analysis at 24 weeks. And for those who have gone beyond 24 weeks, to look at their longer-term data as well. And based on that result, we will then, if positive and strong, we will proceed seamlessly into the phase III portion of the study. And based on those data, the final sample size will be determined. Charlie YangSenior Equity Research Analyst of Biotech and Pharma at Bank of America00:21:08Great, thanks. Maybe just one quick follow-up, just in terms of the Wolfram opportunity in Europe, how does that kind of compare to the U.S.? Thank you. Camille BedrosianChief Medical Officer at Amylyx Pharmaceuticals00:21:18Yes. So we are certainly aware of endocrinologists who are familiar with Wolfram and have a large, large, relatively speaking, Wolfram population. So, but right now we are focusing on the U.S. and, so we do... Yeah. So, more to come on that as we do more research. Josh CohenCEO at Amylyx Pharmaceuticals00:21:39I would add that, you know, Wolfram being a monogenic disease, we do see people with Wolfram syndrome all around the world. Camille BedrosianChief Medical Officer at Amylyx Pharmaceuticals00:21:47Yes. Josh CohenCEO at Amylyx Pharmaceuticals00:21:48So it is very much a global unmet need. Operator00:21:55Thank you. Your next question comes from the line of Corinne Jenkins from Goldman. Please go ahead. Palak JhajhariaEquity Research Associate at Goldman00:22:05Hi, good morning. This is Palak on for Corinne. Two from us on the PSP front. The first being, what do prior studies in PSP suggest for placebo and natural history population at the 24-week time point? And then the second was, what are you thinking about in terms of the threshold for futility at the 24-week endpoint in the interim analysis? Thank you. Camille BedrosianChief Medical Officer at Amylyx Pharmaceuticals00:22:27Yep. So, as you are alluding, in fact, the progression of the disease is actually quite reproducible. There were 3 relatively large phase III studies in PSP, unfortunately, none of which showed a benefit of the active drug, but it did show that there was reproducible deterioration at a relatively similar rate. So we do use that as a basis for understanding and looking at the data coming out. Josh CohenCEO at Amylyx Pharmaceuticals00:23:04And, you know, as your other question, too, on the threshold for futility, this is not a, you know, formal futility analysis. We're doing a full evaluation of the data, so we'll be looking at, you know, kind of a full top-line release, you know, essentially a phase IIB release, when we do that interim analysis. And just, you know, highlighting, Camille's point as well, when you look, at the past, you know, larger randomized placebo-controlled studies that have been conducted in PSP, the placebo rate is actually, you know, quite strikingly consistent, you know, usually at just under a point a month. Palak JhajhariaEquity Research Associate at Goldman00:23:40Understood. Thank you. Operator00:23:43Thank you. Your next question comes from the line of Umer Raffat from Maverick Capital. Please go ahead. Xiang ChenFinancial Analyst at Thrive Alternatives Capital Advisory00:23:51Hi, good morning. This is Chen Xiang on for Umar. Thanks for taking our questions. I guess, firstly, for Wolfram syndrome phase III trial, does it need to be placebo-controlled? And secondly, for AMX0114, are you planning to give incremental data update as it progresses, maybe the timing between phase II Wolfram trial data this fall and the phase III PSP interim next year? Camille BedrosianChief Medical Officer at Amylyx Pharmaceuticals00:24:13Right. So thank you for the questions. This is Camille. Regarding Wolfram, as we indicated in our prepared remarks, we are engaging with stakeholders that include, of course, the FDA, and once our plans are finalized, we'll share those with you. Just as a reminder, later this fall, we will share data on all 12 participants through 24 weeks, and additional longer-term data for those individuals who have gone through week 36 and 48. So we're looking forward to those readouts as well. And then regarding zero one one four, as we indicated, we are planning to initiate our multiple ascending dose study in individuals with ALS by the end of the year. And as the study progresses, we'll be able to provide more detailed timing and types of data we'll be sharing through 2025. Xiang ChenFinancial Analyst at Thrive Alternatives Capital Advisory00:25:12Thank you. Operator00:25:15Thank you. Your next question comes from the line of Graig Suvannavejh from Mizuho Financial Group. Please go ahead. Charles YangDirector of Project Management at Mizuho Financial Group00:25:25Good morning, everyone. This is Charles Yang in for Greg. Thanks for taking our question. We were wondering, what type of data will you present at the updated data presentation for HELIOS? Should we expect it to be similar to the interim readout earlier this year? Thanks. Camille BedrosianChief Medical Officer at Amylyx Pharmaceuticals00:25:39Yep, thank you. This is Camille again. Indeed, so we do intend to provide longer-term data for those individuals about whom we reported in April of this year, as well as data through 24 weeks for all 12 participants. It's top line data, primary endpoint, and key secondary endpoints, and we look forward to sharing those details with you at the upcoming international meeting. Operator00:26:05Thank you, Greg. Your next question comes from the line of Marc Goodman from Leerink Partners. Please go ahead. Rudy LiEquity Research Analyst at Leerink Partners00:26:28Hi, thanks for taking my question. This is Rudy on the line for Mark. Can you talk about R&D expenses going into 2025? What is your strategy to build the pipeline going forward with both internal and external assets? Thanks. Jim FratesCFO at Amylyx Pharmaceuticals00:26:46Yeah, thank you. It's Jim. Good morning. I think one of the things that is happening on our R&D line, right? As our restructuring has occurred, and as the large Phoenix phase III winds down, and you can find some detail on those expenses historically in our Qs. That really opens up room for some of the new spending that we have going on. And, you know, currently the Wolfram study is ongoing. The PSP study is starting to move up into a range where that, you know, that's gonna be consistent as opposed to really growing. And so that leaves us room as we move forward, to spend on the 114 study and the new Avexitide program. Jim FratesCFO at Amylyx Pharmaceuticals00:27:26Then just overall, as we outlined, we expect cash expense, now that's excluding non-cash comp, to be in the range of $30 million-$40 million a quarter for both R&D and SG&A. So that's how some of the moving parts are going into 2025. Rudy LiEquity Research Analyst at Leerink Partners00:27:42Very helpful. Thanks. Jim FratesCFO at Amylyx Pharmaceuticals00:27:44You're welcome. Operator00:27:47Thank you. Your next question comes from the line of Joel Beatty from Baird. Please go ahead. Joel BeattyBiotechnology Equity Research Analyst at Baird00:27:56Hi, thanks for taking the questions. For the PSP interim analysis, to get data around mid-2025, does that mean completing enrollment around the end of this year? And what gives you confidence on the trial completing enrollment around that timeframe? Camille BedrosianChief Medical Officer at Amylyx Pharmaceuticals00:28:13Yes. Hi, Joel, this is Camille. We are enrolling quite well, as I indicated in our prepared remarks, and we're tracking toward having data mid-2025. We'll give more information as we march toward that timeframe. Joel BeattyBiotechnology Equity Research Analyst at Baird00:28:29Great. And then, as a follow-up, do you anticipate any more acquisitions after the recent acquisition of Avexitide? Justin KleeCEO at Amylyx Pharmaceuticals00:28:38Yeah. You know, I'll say we wouldn't. You know, we've had a process ongoing for some time, where we're evaluating, you know, many assets for, you know, that, you know, whether they fit well into our pipeline and have the requisite, you know, scientific and clinical and commercial, you know, path forward. Today, we're very excited about the assets we, you know, have today, and that's our focus. But, you know, we're always looking, and I, I'd say we wouldn't rule out, you know, adding additional things in. Joel BeattyBiotechnology Equity Research Analyst at Baird00:29:10Thank you. Operator00:29:11Thank you. There are no further questions at this time. I'll turn the call back to Mr. Klee. Justin KleeCEO at Amylyx Pharmaceuticals00:29:18Thank you for joining us today on today's call to discuss our second quarter 2024 financial results. Have a great day. Operator00:29:31Thank you for joining today's call. Please disconnect your line. Thank you.Read moreParticipantsExecutivesCamille BedrosianChief Medical OfficerJim FratesCFOJosh CohenCEOJustin KleeCEOLindsey AllenHead of Investor RelationsAnalystsCharles YangDirector of Project Management at Mizuho Financial GroupCharlie YangSenior Equity Research Analyst of Biotech and Pharma at Bank of AmericaJoel BeattyBiotechnology Equity Research Analyst at BairdPalak JhajhariaEquity Research Associate at GoldmanRudy LiEquity Research Analyst at Leerink PartnersXiang ChenFinancial Analyst at Thrive Alternatives Capital AdvisoryPowered by