Amylyx Pharmaceuticals, Inc. Common Stock 2026 Q2 Earnings Call

Please proceed. Good morning. Thank you all for joining us today to discuss our second quarter 2026 financial results and business updates.

With me on the call today are Josh Cohen and Justin Klee, our Co-CEOs, Dr. Camille Bedrosian, our Chief Medical Officer, Dan Monahan, our Chief Commercial Officer, and James 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, AMX0114, and AMX0318, statements regarding regulatory and clinical developments, the impact thereof, and the expected timing thereof, and statements regarding our cash runway.

Actual events and results could differ materially from those expressed or implied by any forward-looking statement. 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.

Good morning, everyone. Thank you for joining us. This is an exciting time for Amylyx and the post-bariatric hypoglycemia community as we approach the pivotal phase III LUCIDITY top-line data readout. At the beginning of the year, we outlined three strategic priorities for avexitide, our investigational first-in-class GLP-1 receptor antagonist with FDA breakthrough therapy designation in post-bariatric hypoglycemia, or PBH. First, advancing the pivotal phase III LUCIDITY trial toward top-line data. The last participant has recently completed their last visit in the trial. We are on track and eagerly anticipating the top-line data readout in late August or early September. The database has yet to be locked at this time, and we remain blinded to the data. Second, in parallel, advancing NDA readiness and regulatory preparations. We're actively preparing all applicable sections of the NDA to support a potential submission.

Third, strengthening our launch readiness to prepare for the potential commercialization of avexitide in 2027, if approved. We have deployed our field medical affairs team to facilitate on-the-ground HCP scientific exchange, and we have continued to build out our teams across marketing, market access, and commercial operations. At ENDO 2026 in June, we activated our disease state education campaign, Uncover the Mystery of Post-Bariatric Hypoglycemia, designed to increase awareness, understanding, and action around PBH. Dan will provide more details on our launch readiness efforts later in the call. We are fully focused on execution as we work toward the potential of delivering the first FDA-approved therapy for people living with PBH. With that, Camille, I'll turn the call over to you.

Thank you, Justin. PBH is characterized by recurrent and often debilitating hypoglycemia, thought to be caused by an exaggerated GLP-1 response, primarily after food intake. The American Diabetes Association recognizes hypoglycemia as a potential medical emergency because low blood glucose levels can compromise the body's ability to maintain essential physiologic processes and can result in cognitive dysfunction, seizures, or loss of consciousness. PBH is a chronic condition with no FDA-approved therapies, and many people with PBH live with the ongoing fear of hypoglycemia. Our pivotal phase III LUCIDITY trial is a randomized, double-blind, placebo-controlled trial evaluating avexitide 90 mg once daily in adults with PBH following Roux-en-Y gastric bypass surgery. The LUCIDITY trial is anchored in the robust data generated to date from the five prior avexitide clinical trials in PBH that demonstrated statistically significant reductions in hypoglycemic events.

The primary endpoint is the FDA agreed upon outcome of reduction in the composite of Level 2 and Level 3 hypoglycemic events through week 16. At the ENDO 2026 annual meeting in June, several case reports describing many aspects of PBH and hypoglycemia were presented, highlighting a growing recognition of PBH and the seriousness of hypoglycemia across the medical community. Dr. Colleen Craig presented a poster characterizing the clinical, economic, and humanistic burden of PBH in the U.S. and evaluating how Level 2 and Level 3 hypoglycemic events in PBH impact healthcare utilization, productivity, and overall cost. At the patient level, patients face direct medical costs, productivity loss, such as missed work, diminished quality of life, caregiver burden, and out-of-pocket non-medical costs. At the systemic level, societies face resource utilization and downstream clinical consequences, in addition to direct healthcare costs, non-medical system costs, and societal productivity loss.

At ENDO 2026, we had meaningful scientific dialogue about PBH with endocrinologists that underscored the tremendous unmet need for people living with this condition. We met many endocrinologists with whom we had not previously engaged, and many of them already were aware of PBH. They described the challenges in managing these individuals, given the limited options for treatment, and had strong interest in learning more about this condition. This interest is inspiring as our field medical affairs team furthers PBH scientific exchange and engagement with endocrinologists. In addition, in June, CMS and CDC published their 2027 ICD-10 code files, which represent the official code set to be used for patient encounters beginning October 1st, 2026. This code set includes an ICD-10 code specific to PBH, also demonstrating the growing recognition of this condition by the medical community.

In closing, we are encouraged by the increasing awareness and understanding of PBH, along with our informative engagements with healthcare professionals. We continue to be focused on strong execution as we approach our anticipated LUCIDITY top-line data readout. With that, Dan, I'll now turn over the call to you.

Thank you, Camille, good morning, everyone. We continue to make significant progress in our preparations for the potential commercialization of avexitide next year. We remain encouraged by the growing recognition of PBH among healthcare professionals. Importantly, our understanding of the PBH population continues to strengthen. We estimate that approximately 160,000 people in the U.S. are living with PBH following the two most common bariatric procedures, Roux-en-Y gastric bypass and sleeve gastrectomy. This estimate remains supported by our independent claims analysis, ongoing field insights, and a growing body of published prospective and retrospective literature. Together, these data continue to reinforce both the significant unmet need and the opportunity to identify and reach appropriate patients. Our market research also continues to demonstrate a high intent among endocrinologists to treat PBH with an approved therapy, providing further confidence in the commercial opportunity should avexitide be approved.

We are excited to share that we recently activated our disease state education campaign, Uncover the Mystery of Post-Bariatric Hypoglycemia, to address the educational need among HCPs and the PBH community. As part of this initiative, we launched uncoverpbh.com. This platform provides educational resources for both healthcare professionals and the PBH community. The HCP website is intended to help clinicians better recognize and understand PBH. The community website empowers people with PBH with information to support discussions with their healthcare teams. As Camille mentioned, engagement at ENDO 2026 was high, where we also introduced an interactive disease state education experience that generated strong engagement and positive feedback. One of our most encouraging early observations was the level of familiarity many healthcare professionals already had with PBH, reinforcing our view that awareness of the condition continues to grow within the endocrinology community.

In parallel, we continue to add key talent across the organization and advance our commercial readiness efforts as we prepare for the potential launch of avexitide in 2027, should it be approved. With that, I will now turn the call over to Jim to review our financials.

Thanks, Dan. Good morning, everyone. Our financial results for the second quarter reflect our continued disciplined execution of the phase III LUCIDITY trial and targeted investment in advancing our broader pipeline. We ended the second quarter with $250.8 million in cash and marketable securities, compared to $279.8 million at the end of the first quarter. This capital provides us with an anticipated cash runway into 2028 to fund our operations through expected milestones, including our key focus, the LUCIDITY top-line readout, potential FDA approval, and potential commercial launch of avexitide in 2027. Turning now to our results for the quarter. Total operating expenses for the quarter were $45.7 million, up 7% for the same period in 2025. Research and development expenses for the quarter were $23.8 million, compared to $27.2 million in Q2 2025.