Md Babul Hosen/iStock via Getty Images
Mineralys Therapeutics, Inc. (NASDAQ:MLYS) has made significant progress for its pipeline, because it has been able to launch two phase 3 studies, which are using lorundrostat for the treatment of patients with uncontrolled and resistant hypertension. One of these two late-stage studies, known as ADVANCE-HTN, is expected to have a data readout in the 2nd half of 2024. However, the second late-stage study for this particular program is not expected to have a data release until the 2nd half of 2025.
While these two catalysts relate to this specific program, that doesn’t mean that there isn’t another one to keep an eye on in a 1-year period. This biotech is also advancing the use of this same drug for the treatment of uncontrolled and resistant hypertension for Chronic Kidney Disease [CKD] patients. Top line results from this phase 2 study are expected to be released in the 1st half of 2024 or Q1 of 2025. It has also been able to capitalize itself with additional funds as well. It just enacted a private placement agreement PIPE financing with several accredited investors for $120 million.
Lorundrostat For The Treatment Of Patients With Hypertension
As I stated above, Mineralys was able to initiate its late-stage program targeting patients with hypertension with the launch of two phase 3 studies. Both of these late-stage studies are evaluating the safety and efficacy of lorundrostat when used as an add-on therapy to standardized background treatment of two or three antihypertensive medications. These studies are known as ADVANCE-HTN and LUANCH-HTN.
Both of them are being deployed to treat patients with uncontrolled hypertension [uHTN] and resistant hypertension [rHTN]. The main study to focus in on would be the ADVANCE-HTN study as part of this late-stage program. Why is that? That’s because results from this first phase 3 study are expected in the 2nd half of 2024. The primary endpoint is going to be a change in systolic blood pressure versus placebo after 12 weeks of treatment, which is measured by 24-hour ambulatory pressure monitoring.
There is a difference between the two phase 3 studies to note. The LAUNCH-HTN study is using lorundrostat as an add on to existing background therapy. Whereas, the other ADVANCE-HTN study is using lorundrostat with standardized background therapy. The move to go to a phase 3 program was based on prior proof-of-concept data, whereby uHTN and rHTN patients given lorundrostat were able to achieve a statistically significant reduction in systolic blood pressure of the following with each different dose:
- 9.6 mmHg reduction for patients given 50 mg QD dosing
- 7.8 mmHg reduction for patients given 100 mg QD dosing.
The main mechanism of action [MOA] for lorundrostat is to reduce aldosterone and thus reduce hypertension in patients. Thus, this drug is a selective aldosterone synthase inhibitor. It was shown that it was able to reduce aldosterone levels by as much as 70%. I believe that value can be established here in that there is a major catalyst expected to take place in the latter part of this year. It is expected that it will release results from the phase 3 ADVANCE-HTN study in the 2nd half of 2024.
The thing is that Mineralys is well equipped to potentially fend off competition in this hypertension space. What do I mean by this? In essence, it has the potential to be the best in class Aldosterone Synthase Inhibitor [ASI] for these patients. For instance, Novartis (NVS) has LCI699, AstraZeneca (AZN) has Baxdrostat and Boehringer Ingelheim has BI690517. Where Mineralys might be able to do well on would be in terms of best-in-class selectivity, thereby greatly improving efficacy and reducing off-target adverse events [AEs]. It also has a well-equipped half-life in place as well.
The truth is that the release of data from the ongoing phase 3 studies ADVANCE-HTN and LAUNCH-HTN are going to settle whether or not lorundrustat can become the best in class ASI out of all these molecules.
Financials
According to the 10-Q SEC Filing, Mineralys Therapeutics had cash, cash equivalents and investments of $266.9 million as of September 30th 2023. It believed that this would be enough cash to fund its operations through mid-2025. However, it chose to enact a cash raise to obtain additional funding for its pipeline. It did so by entering into a securities purchase agreement with institutional accredited investors to sell securities in a private placement financing for gross proceeds of approximately $120 million. The PIPE is currently ongoing and it is not expected to close until February 12th of 2024. With this newly added cash on hand, I believe that it is well capitalized to reach several milestones which are expected in a 1-year period.
Risks To Business
There are several risks that investors should be aware of before investing in Mineralys Therapeutics. The first risk to consider would be with respect to the release of results from the phase 3 ADVANCE-HTN study, which is using lorundrostat for the treatment of patients with uHTN and rHTN. There is no assurance that the primary endpoint of this study is going to be met with statistical significance. The same can be said with respect to the other ongoing phase 3 LAUNCH-HTN study, although that’s not expected until late 2025.
The second risk to consider would be with respect to the advancement of lorundrostat beyond only targeting uHTN and rHTN. That’s because the company is already in the process of attempting to reduce hypertension observed in patients with chronic kidney disease [CKD] as well. Even if the primary endpoint is met in the ADVANCE-HTN study, that’s no guarantee that the drug will be effective in the CKD patient population.
The third and final risk to consider would be with respect to the big pharma competitors I described above. That’s because Novartis, AstraZeneca and Boehringer Ingelheim are all developing aldosterone synthase inhibitors of their own. However, I believe what sets Mineralys’ lorundrostat apart from all of the competition is highly effective selectivity. I evidenced this above with the 370X sensitivity generated by it. I believe such selectivity could possibly have an impact on achieving superior efficacy and reduced adverse events [AEs].
Conclusion
Mineralys Therapeutics has made significant progress in being able to help patients with hypertension, either uncontrolled or resistant. I believe that investors can benefit greatly if successful results are released from the phase 3 ADVANCE-HTN study in the 2nd half of 2024. In essence, the primary endpoint of this study must be met with statistical significance. The company is definitely well capitalized after having received $120 million in private placement financing from accredited institutional investors.
The global hypertension market is expected to reach $43.18 billion by 2030. There is an opportunity to capture it with respect to targeting hypertension patients of all kinds, even those who have Chronic Kidney Disease [CKD] as well.
Editor’s Note: This article discusses one or more securities that do not trade on a major U.S. exchange. Please be aware of the risks associated with these stocks.
