Mineralys IPO Lands $192M for Blood Pressure Trials and Chance to Challenge AstraZeneca

Wall Street

Mineralys Therapeutics’ hypertension drug candidate could offer a new treatment option for patients who don’t adequately respond to currently available blood pressure medicines. The once-daily pill is nearing a pivotal test, and Mineralys has raised $192 million in IPO cash to finance its clinical trial plans.

When Mineralys set preliminary terms for the IPO last week, it planned to sell 10 million shares in the range of $14 to $16 per share. The Radnor, Pennsylvania-based company ended up adding 2 million shares to the offering, which priced late Thursday at the top of the projected price range. Those shares began trading Friday on the Nasdaq under the stock symbol “MLYS.”

Many patients who have hypertension take multiple medications to manage the condition. However, more than half of the 115 million people in the U.S. with sustained elevated blood pressure fail to meet their blood pressure reduction goals, Mineralys says in its IPO filing. That failure puts these patients at greater risk of death due to cardiovascular disease or stroke.

Standard-of-care drugs include angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs), which work by lowering levels of aldosterone, a hormone that regulates blood pressure. Another class of drugs work by blocking aldosterone’s activity at the called mineralcorticoid receptor.

Mineralys aims to address aldosterone, but in a different way than currently available medications. Its small molecule drug, lorundrostat (previously known as MLS-101), is an aldosterone synthase inhibitor (ASI). It blocks aldosterone synthase, an enzyme key to the synthesis of the hormone. The company says its molecule is highly selective, hitting its enzyme target without also hitting other targets, such as the hormone cortisol.

“Several large pharmaceutical companies have tried to develop ASIs, but their efforts have been hampered due to insufficient selectivity for aldosterone, resulting in off-target toxicities associated with cortisol inhibition,” Mineralys said in the filing. “These challenges have led to the discontinuation of many ASIs in development to date.”

Last November, Mineralys reported preliminary data from a placebo-controlled Phase 2 test enrolling 200 patients with uncontrolled or treatment-resistant hypertension. Those participants had been taking up to two anti-hypertensive drugs to manage their blood pressure. Results showed the study met its blood pressure reduction goals. Furthermore, the study drug was well tolerated by patients. Serious adverse events were reported in three participants. In two of them, the effects were deemed unrelated to the drug. The third patient had pre-existing below normal sodium levels in the blood, which reversed after stopping treatment with the Mineralys drug.

The next step for lorundrostat is another Phase 2 study to evaluate the safety and efficacy of the molecule when used as an add-on therapy in patients who are taking two or three anti-hypertensive medications. This double blind, placebo-controlled study will enroll up to 240 adults and will start in the first half of this year.

Meanwhile, Mineralys plans to start a Phase 3 study in the second half of this year. The trial design will be similar to that of the Phase 2 study except it will have more patients—up to 1,000 adults with uncontrolled or treatment-resistant hypertension. Preliminary data are expected in mid-2025. Mineralys also wants to see how its drug works addressing hypertension in patients with chronic kidney disease. A Phase 2 study is expected to start in the middle of this year.

Mineralys is pursuing its clinical trial plans as rival CinCor Pharma prepares for a pivotal test of its aldosterone synthase inhibitor, baxdrostat. Despite failing in Phase 2 last November, the biotech reported encouraging results in a subgroup of patients that it said could inform the design of a Phase 3 study. AstraZeneca apparently sees potential in the CinCor drug. Last month, it agreed to pay $1.3 billion to acquire CinCor.

Lorundrostat traces its origins to Mitsubishi Tanabe, which discovered the molecule and advanced it as far as Phase 1 testing. Venture capital firm Catalys Pacific founded Mineralys in 2019, according to the filing. The following year, Mineralys licensed global rights to lorundrostat, paying $1 million up front. The deal includes milestone payments of up to $9 million for development and $155 million if the drug reaches the market.

Mineralys has raised $158 million since its inception, most recently a $118 million Series B financing last June led by RA Capital and Andera Partners. According to the prospectus, Catalys Pacific is Mineralys’s largest shareholder, owning a 24.1% post IPO stake, followed by Samsara Capital’s 9.7% stake.

Mineralys’s CEO is Jon Congleton, a veteran of Impel NeuroPharma, Nivalis Therapeutics, and Teva Pharmaceutical Industries. The company reported its cash position was $110.4 million at the end of 2022. It estimates that this capital combined with the IPO proceeds will be sufficient to fund operations for at least the next 18 months—enough time for the two planned Phase 2 tests of lorundrostat to report preliminary data.

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