Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage
biopharmaceutical company focused on developing medicines to target
hypertension, chronic kidney disease (CKD) and other diseases
driven by dysregulated aldosterone, today announced financial
results for the second quarter ending June 30, 2024, and provided a
corporate update.
“During the first half of 2024, we continued to make progress
executing our pivotal development program for lorundrostat to treat
uHTN or rHTN. Considering the current pace of enrollment in the
Advance-HTN trial, which is approximately 90 percent enrolled, we
anticipate announcing topline data during the first quarter of
2025. To our knowledge, this will be one of the most rigorous
trials ever completed for an aldosterone targeted therapy,” stated
Jon Congleton, Chief Executive Officer of Mineralys Therapeutics.
“In addition, we have significantly ramped up enrollment in our
pivotal Launch-HTN trial, which is well ahead of schedule compared
to our enrollment projections.”
Recent Clinical Highlights and Upcoming
Milestones
- Pivotal Advance-HTN
Trial – Based on the anticipated timing of full
enrollment, the Company is guiding to announce top-line data in the
first quarter of 2025. The trial is evaluating the efficacy and
safety of lorundrostat for the treatment of uncontrolled
hypertension (uHTN) or resistant hypertension (rHTN), when used as
an add-on therapy to a standardized background treatment of two or
three antihypertensive medications. In August 2024, the Company met
with the FDA and aligned on maintaining the primary endpoint for
the Advance-HTN trial as the change in 24-hour ambulatory systolic
blood pressure (BP) at week twelve from baseline for active cohorts
versus placebo.
- Pivotal Launch-HTN Phase 3
Trial – Enrollment in the Launch-HTN Phase 3 trial is
ahead of schedule, with topline data on track to be available in
the second half of 2025. This is the second ongoing pivotal trial
of lorundrostat for the treatment of subjects with uHTN or rHTN as
add-on therapy, who fail to achieve blood pressure control on their
existing, prescribed background treatment of two to five
antihypertensive medications.
- Explore-CKD Phase 2
Trial – The ongoing trial to evaluate the safety and
efficacy of lorundrostat when added to background treatment with
SGLT2 inhibitor as a potential therapy to treat patients with uHTN
or rHTN and Stage 2 to 3b CKD. The amended protocol is implemented,
enrollment is ramping up and we anticipate topline data in the
first half of 2025.
- Transform-HTN Open-Label
Extension Trial –The Company’s ongoing open-label
extension trial allows subjects to continue to receive lorundrostat
and obtain additional safety and efficacy data.
Second Quarter
2024 Financial Highlights
Cash, cash equivalents and investments were $311.1 million as of
June 30, 2024, compared to $239.0 million as of December 31, 2023.
The Company believes that its current cash, cash equivalents and
investments will be sufficient to fund its planned clinical
studies, as well as support corporate operations, into 2026.
Research and Development (R&D) expenses for the quarter
ended June 30, 2024 were $39.3 million, compared to $11.9 million
for the quarter ended June 30, 2023. The increase in R&D
expenses was primarily due to increases of $22.8 million in
preclinical and clinical costs driven by the initiation of the
lorundrostat pivotal program in the second quarter of 2023 and the
Explore-CKD trial in the fourth quarter of 2023, $2.6 million in
clinical supply, manufacturing and regulatory costs, $1.7 million
in higher compensation expense resulting from additions to
headcount, increases in salaries and accrued bonuses and increased
stock-based compensation and $0.3 million in other research
and development expenses.
General and Administrative (G&A) expenses were $5.9 million
for the quarter ended June 30, 2024, compared to $3.9 million for
the quarter ended June 30, 2023. The increase in G&A expenses
was primarily due to $1.5 million in higher compensation expense
resulting from additions to headcount, increases in salaries and
accrued bonuses and increased stock-based compensation and
$0.5 million in higher professional fees and other
administrative expenses.
Total other income, net was $4.2 million for the quarter ended
June 30, 2024, compared to $3.6 million for the quarter ended June
30, 2023. The increase was primarily attributable to increased
interest earned on the Company’s investments in money market funds
and U.S. treasuries.
Net loss was $41.0 million for the quarter ended June 30, 2024,
compared to $12.1 million for the quarter ended June 30, 2023. The
increase was primarily attributable to the factors impacting the
Company’s expenses described above.
Conference Call
The Company’s management team will host a conference call at
4:30 p.m. ET on Tuesday, August 13, 2024. To access the call,
please dial 1-877-407-9127 in the U.S. or 1-201-689-8574 outside
the U.S., followed by the conference ID: 13747982. A live webcast
of the conference call may be found here. A replay of the call will
be available on the “News & Events” page in the Investor
Relations section of the Mineralys Therapeutics website.
About Hypertension
Having sustained, elevated blood pressure (or hypertension)
increases the risk of heart disease, heart attack and stroke, which
are leading causes of death in the U.S. In 2020, more than 670,000
deaths in the U.S. included hypertension as a primary or
contributing cause. Hypertension and related health issues resulted
in an average annual economic burden of about $130 billion each
year in the U.S., averaged over 12 years from 2003 to 2014.
Less than 50 percent of hypertension patients achieve their
blood pressure goal with currently available medications.
Dysregulated aldosterone levels are a key factor in driving
hypertension in approximately 25 percent of all hypertensive
patients.
About Chronic Kidney Disease (CKD)
CKD, which is characterized by the gradual loss of kidney
function, is estimated to affect more than 10% of the global
population and is one of the leading causes of mortality worldwide.
According to the U.S. Centers for Disease Control and Prevention
(CDC), an estimated 1-in-7 (15%) of U.S. adults have CKD. Diabetes
and hypertension are responsible for approximately two-thirds of
CKD cases. Early detection and treatment can often keep CKD from
getting worse. When CKD progresses, it may eventually lead to
kidney failure, which requires dialysis or a kidney transplant to
maintain life.
About Lorundrostat
Lorundrostat is a proprietary, orally administered, highly
selective aldosterone synthase inhibitor being developed for the
treatment of uncontrolled hypertension and CKD. Lorundrostat was
designed to reduce aldosterone levels by inhibiting CYP11B2, the
enzyme responsible for its production. Lorundrostat has 374-fold
selectivity for aldosterone-synthase inhibition versus
cortisol-synthase inhibition in vitro, an observed half-life of
10-12 hours and demonstrated approximately a 70% reduction in
plasma aldosterone concentration in hypertensive subjects.
In a Phase 2, proof-of-concept trial (Target-HTN) in
uncontrolled or resistant hypertensive subjects, once-daily
lorundrostat demonstrated clinically meaningful blood pressure
reduction in individuals with uncontrolled hypertension, in both
automated office blood pressure measurement and 24-hour ambulatory
blood pressure monitoring. Adverse events observed were a modest
increase in serum potassium, decrease in estimated glomerular
filtration rate, urinary tract infection and hypertension with one
serious adverse event possibly related to study drug being
hyponatremia.
About Mineralys
Mineralys Therapeutics is a clinical-stage biopharmaceutical
company focused on developing medicines to target hypertension, CKD
and other diseases driven by dysregulated aldosterone. Its initial
product candidate, lorundrostat, is a proprietary, orally
administered, highly selective aldosterone synthase inhibitor that
Mineralys Therapeutics is developing for cardiorenal conditions
affected by dysregulated aldosterone, including hypertension and
CKD. Mineralys is based in Radnor, Pennsylvania, and was founded by
Catalys Pacific. For more information, please visit
https://mineralystx.com. Follow Mineralys on LinkedIn and
Twitter.
Forward Looking Statements
Mineralys Therapeutics cautions you that statements contained in
this press release regarding matters that are not historical facts
are forward-looking statements. The forward-looking statements are
based on our current beliefs and expectations and include, but are
not limited to, statements regarding: the potential therapeutic
benefits of lorundrostat; the Company’s expectation that
aldosterone synthase inhibitors with an SGLT2 inhibitor may provide
additive clinical benefits to patients; the Company’s expectation
that the Advance-HTN and the planned Phase 3 clinical trial of
lorundrostat may serve as pivotal trials in any submission of a new
drug application (NDA) to the United States Food and Drug
Administration (FDA); the Company’s ability to evaluate
lorundrostat as a potential treatment for CKD or uncontrolled
hypertension; the planned future clinical development of
lorundrostat and the timing thereof; and the expected timing of
commencement and enrollment of patients in clinical trials and
topline results from clinical trials. Actual results may differ
from those set forth in this press release due to the risks and
uncertainties inherent in our business, including, without
limitation: our future performance is dependent entirely on the
success of lorundrostat; potential delays in the commencement,
enrollment and completion of clinical trials and nonclinical
studies; later developments with the FDA may be inconsistent with
the feedback from the completed end of Phase 2 meeting, including
whether the proposed pivotal program will support registration of
lorundrostat which is a review issue with the FDA upon submission
of an NDA; our dependence on third parties in connection with
manufacturing, research and clinical and nonclinical testing;
unexpected adverse side effects or inadequate efficacy of
lorundrostat that may limit its development, regulatory approval
and/or commercialization; unfavorable results from clinical trials
and nonclinical studies; results of prior clinical trials and
studies of lorundrostat are not necessarily predictive of future
results; our ability to maintain undisrupted business operations
due to any pandemic or future public health concerns; regulatory
developments in the United States and foreign countries; our
reliance on our exclusive license with Mitsubishi Tanabe Pharma to
provide us with intellectual property rights to develop and
commercialize lorundrostat; and other risks described in our
filings with the Securities and Exchange Commission (SEC),
including under the heading “Risk Factors” in our annual report on
Form 10-K, and any subsequent filings with the SEC. You are
cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date hereof, and we
undertake no obligation to update such statements to reflect events
that occur or circumstances that exist after the date hereof. All
forward-looking statements are qualified in their entirety by this
cautionary statement, which is made under the safe harbor
provisions of the Private Securities Litigation Reform Act of
1995.
Contact:Investor
Relationsinvestorrelations@mineralystx.com
Media RelationsTom WeibleElixir
Health Public RelationsPhone: (1) 515-707-9678Email:
tweible@elixirhealthpr.com
Mineralys Therapeutics, Inc.Condensed
Statements of Operations(in thousands, except
share and per share data)(unaudited) |
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
June 30, |
|
June 30, |
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
39,273 |
|
|
$ |
11,884 |
|
|
$ |
70,027 |
|
|
$ |
24,177 |
|
General and administrative |
|
5,895 |
|
|
|
3,851 |
|
|
|
10,503 |
|
|
|
6,496 |
|
Total operating expenses |
|
45,168 |
|
|
|
15,735 |
|
|
|
80,530 |
|
|
|
30,673 |
|
Loss from operations |
|
(45,168 |
) |
|
|
(15,735 |
) |
|
|
(80,530 |
) |
|
|
(30,673 |
) |
Interest income, net |
|
4,152 |
|
|
|
3,593 |
|
|
|
8,005 |
|
|
|
5,922 |
|
Other income |
|
2 |
|
|
|
1 |
|
|
|
3 |
|
|
|
2 |
|
Total other income, net |
|
4,154 |
|
|
|
3,594 |
|
|
|
8,008 |
|
|
|
5,924 |
|
Net loss |
$ |
(41,014 |
) |
|
$ |
(12,141 |
) |
|
$ |
(72,522 |
) |
|
$ |
(24,749 |
) |
Net loss per share
attributable to common stockholders, basic and diluted |
$ |
(0.83 |
) |
|
$ |
(0.31 |
) |
|
$ |
(1.54 |
) |
|
$ |
(0.77 |
) |
Weighted-average shares used
to compute net loss per share attributable to common stockholders,
basic and diluted |
|
49,356,287 |
|
|
|
39,754,981 |
|
|
|
47,178,288 |
|
|
|
32,301,136 |
|
Mineralys Therapeutics, Inc.Selected
Financial InformationCondensed Balance Sheet
Data(amounts in
thousands)(unaudited) |
|
|
June 30, |
|
December 31, |
|
|
2024 |
|
|
2023 |
Cash, cash equivalents and
investments |
$ |
311,115 |
|
$ |
239,049 |
Total assets |
$ |
318,492 |
|
$ |
251,636 |
Total liabilities |
$ |
28,397 |
|
$ |
10,482 |
Total stockholders’
equity |
$ |
290,095 |
|
$ |
241,154 |
Mineralys Therapeutics (NASDAQ:MLYS)
Historical Stock Chart
From Jul 2024 to Aug 2024
Mineralys Therapeutics (NASDAQ:MLYS)
Historical Stock Chart
From Aug 2023 to Aug 2024