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8/11/2026
Welcome to the Mineralis Therapeutics second quarter 2026 conference call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. Should anyone require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Dan Ferry of LifeSci Advisors. Please go ahead, sir.
Thank you. I would like to welcome everyone joining us today for our second quarter 2026 conference call. This afternoon, after the close of market trading, we issued a press release providing our second quarter 2026 financial results and business updates. A replay of today's call will be available on the investor section of our website approximately one hour after its completion. After our prepared remarks, we will open the call for Q&A. Before we begin, I would like to remind everyone that this conference call and webcast will contain forward-looking statements about the company. Actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the company's business. These forward-looking statements are qualified by the cautionary statements contained in today's press release and our SEC filings, including our annual report on Form 10-K and subsequent filings. Please note that these forward-looking statements reflect our opinions only as of today, August 11, 2026. Except as required by law, we specifically disclaim any obligation to update or revise these forward-looking statements in light of new information or future events. I would now like to turn the call over to Jon Congleton, Chief Executive Officer of Mineralis Therapeutics.
Thank you, Dan. Good afternoon, everyone. Welcome to our second quarter 2026 financial results and corporate update conference call. I'm joined today by Adam Levy, our chief financial officer, and Eric Warren, our chief commercial officer. I'll begin with an overview of the business and recent milestones. Eric will then provide a commercial update, and Adam will review our second quarter financial results before we open the call for your questions. Before I get started with the business update, I would like to take a moment to welcome Dr. Terry Ferguson to the team. Terry joins us as Chief Medical Officer, succeeding Dr. David Rodman, who will continue to play an important role as a full-time strategic advisor to the company. Terry brings more than 35 years of experience in cardiovascular medicine, clinical development, and executive leadership. He served as cardiovascular therapeutic area head at Amgen and held senior cardiovascular leadership roles at AstraZeneca and the Medicines Company. He also spent more than 20 years on the faculty of the Texas Heart Institute and in cardiovascular medicine, a proven track record of Terry's deep expertise in cardiovascular medicine and a proven track record of advancing innovative therapies positions him well to lead our medical and late-stage clinical activities as we continue preparing for the potential commercialization of lorondrastat. I want to thank David for his dedication and hard work over the past several years. During his time as Chief Medical Officer, he guided the development of Lurenderstadt from proof of concept through the pivotal program and our recent new drug application filing with the FDA. In the second quarter, our focus was on commercial launch readiness, the evaluation of partnering opportunities, and the next steps in the clinical development of Lurenderstadt. In the third quarter, we continue to build our commercial infrastructure as we approach our December 22nd PDUFA date. Turning to our clinical progress, our Transform-HTN open-label extension trial continues to generate valuable long-term safety and efficacy data that further supports Lurunderstat's potential best-in-class profile. In May, we presented a post-hoc analysis from our Pivotal Launch-HTN trial at the European Society of Hypertensions annual meeting. The analysis focused on participants with chronic kidney disease, a high risk and difficult to treat patient population. Despite entering the trial with more severe hypertension and greater use of background antihypertensive therapies, these participants experienced statistically and clinically meaningful blood pressure reductions comparable to those observed in the broader trial population. In addition, participants with baseline albinuria achieved a 52% placebo-adjusted reduction in urine albumin to creatinine ratio, an important marker of kidney injury and disease progression. Just a few weeks later, at the Endocrine Society's annual meeting, INDO 2026, we presented late-breaking proteomic data from our launch HTN and advanced HTN trials, demonstrating that lorunderstat was associated with significant reductions in multiple biomarkers of heart failure risk, While exploratory in nature, these coordinated biomarker changes provide additional biological evidence that lorunderstat use may favorably modulate disease pathways implicated in heart failure. We believe these findings further strengthen our understanding of the broader biological implications of aldosterone and the potential for lorunderstat to provide benefits in hypertension and related comorbidities. We continue to evaluate further clinical development for Larundersat and will keep you informed on our progress as appropriate. We also completed several corporate initiatives that enabled our long-term value creation objectives. During the quarter, we announced an agreement to repurchase the potential future royalty payments due to Tanabe Pharma Corporation related to Larundersat. Under the terms of the agreement, Mineralis agreed to pay Tanabe $200 million up front and up to $100 million once certain commercial milestones are met. Our aggregate potential future milestone payments to Tanabe are now up to $265 million. We believe this represented a unique strategic opportunity to enhance the long-term value of La Runderstad as we approach commercialization. Concurrently, we completed a $150 million equity offering and entered into a $500 million committed senior secured term loan facility with funds managed by Pharmacon Advisors. Beyond funding the royalty repurchase, this facility provides Mineralis with access to additional capital and financial flexibility while positioning Mineralis to capture the long-term value of La Runderstad. As we look ahead to the remainder of the year, We believe Lurenderstat is entering an exciting new phase in its evolution. We have continued to build the clinical evidence supporting Lurenderstat, enhanced the long-term value of the asset, expanded our access to capital, and continue to make meaningful progress preparing for a potential commercial launch. In parallel, we continue to evaluate partnering opportunities and engage in strategic discussions to enhance value, and enable us to reach more patients who could benefit from lorunderstat. With that, I'll turn the call over to Eric to provide a commercial update.
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