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8/6/2026
Good morning, my name is Carrie, and I will be your conference operator today. At this time, I would like to welcome everyone to the MLX Pharmaceuticals Second Quarter 2026 Earnings Conference Call. All participants will be enabled in 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 one again. 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, Vice President, Investor Relations and Communications. Please proceed.
Good morning, and 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 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 state's harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, our expectations with respect to vexatide AMX35, AMX114, and AMX318, statements regarding regulatory and clinical development, 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 statements. You are cautioned not to place any undue reliance on these forward-looking statements and AMLEX disclaims any obligation to update such statements unless required by law. Now, I will turn the call over to Justin.
Good morning, everyone, and thank you for joining us. This is an exciting time for AMLEX 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 Avexatide, our investigational, First-in-Class GLP-1 Receptor Antagonist with FDA Drake 2 Therapy designation in post-bariatric hypoglycemia or TBH. First, advancing the Pivotal Phase 3 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 are actively preparing all applicable sections of the NDA to support a potential submission. And third, strengthening our launch readiness to prepare for the potential commercialization of Avexatide 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 TBH. Dan will provide more details on our launch readiness efforts later in the call. We're fully focused on execution as we work toward the potential of delivering the first FDA-approved therapy for people living with TBH. With that, Camille, I'll turn the call over to you.
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