Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage
biopharmaceutical company focused on developing medicines to target
diseases driven by abnormally elevated aldosterone, today announced
financial results for the quarter ending June 30, 2023, and
provided a corporate update.
“Our team continued to make significant progress in executing
our development strategy for lorundrostat during the first half of
2023. The pivotal development program for lorundrostat to treat
uncontrolled hypertension (uHTN) or resistant hypertension (rHTN)
is well underway, with enrollment in the Advance-HTN trial ongoing
and initiation of the Phase 3 Launch-HTN trial expected in the
second half of the year,” stated Jon Congleton, Chief Executive
Officer of Mineralys Therapeutics. “Most recently, we announced the
decision to expand our planned Phase 2 trial of lorundrostat for
treating patients with chronic kidney disease (CKD), which we plan
on initiating during the second half of 2023. The role of
aldosterone in the progression of CKD is well established. This
trial will evaluate the benefit of inhibiting aldosterone
production with lorundrostat as a more complete solution and
promising approach to treat CKD patients.”
Recent Corporate and Clinical Highlights
- Enrollment on track for pivotal Advance-HTN
trial – Since initiating patient dosing in the ongoing
Advance-HTN Phase 2 trial in April 2023, additional clinical sites
have been onboarded and enrollment of subjects is on track. The
Advance-HTN Phase 2 trial is evaluating the safety and efficacy of
lorundrostat for the treatment of uHTN or rHTN, when used as an
add-on therapy to standardized background treatment of two or three
antihypertensive medications in up to approximately 300 adult
subjects. The topline data from this trial is expected in the first
half of 2024.
- Open-label extension trial for long-term safety
exposure – In mid-2023, the Company initiated an
open-label extension trial to obtain additional safety data. All
subjects in the pivotal hypertension program, including the
Advance-HTN and Launch-HTN trials, will be given the opportunity to
participate in the extension trial.
- Announced expansion of the Phase 2 trial for
lorundrostat in CKD subjects – In July 2023, the Company
announced details of an expanded two-part Phase 2 clinical trial
for lorundrostat as a potential therapy to treat patients with
Stage 2 to 4 CKD. The trial will now include a proof-of-concept
study (Part A) evaluating lorundrostat alone and in combination
with an SGLT2 inhibitor in subjects with mild to moderate CKD,
estimated glomerular filtration rate (eGFR) 45-90 ml/min/1.73m2,
with persistent proteinuria despite treatment with an
angiotensin-converting enzyme (ACE) inhibitor or angiotensin II
receptor blocker (ARB). Part A is designed to evaluate the benefit
of lorundrostat on proteinuria in this CKD population. The second
part of the trial is a profiling study (Part B), which will
characterize the safety profile of lorundrostat in subjects with
moderate to severe CKD, eGFR 25-44 ml/min/1.73m2, with and without
hypertension, despite treatment with an ACE inhibitor or ARB. The
trial is expected to start enrolling patients in the second half of
2023.
Key Upcoming Milestones
- Initiation of the Phase 2 trial of lorundrostat in
CKD – In the second half of 2023, the Company plans to
initiate the two-part Phase 2 trial of lorundrostat for the
treatment of subjects with CKD. Topline data from this trial are
anticipated between the fourth quarter of 2024 and the first
quarter of 2025. As an exploratory trial, the Company may conduct
interim data analyses at one or more time points.
- Phase 3 pivotal Launch-HTN trial – In the
second half of 2023, the Company plans to initiate a randomized,
double-blind, placebo-controlled Phase 3 trial to evaluate the
safety and efficacy of lorundrostat for the treatment of uHTN or
rHTN, when used as an add-on therapy to prescribed background
treatment of two to five antihypertensive medications in up to
approximately 1,000 adult subjects. The topline data from this
trial is expected in mid-2025.
Second Quarter
2023 Financial Highlights
Cash, cash equivalents and investments were $282.8 million
as of June 30, 2023, compared to $110.1 million as of
December 31, 2022. The Company believes that its cash, cash
equivalents and investments as of June 30, 2023 will be
sufficient to allow the Company to fund its planned clinical
studies, as well as support corporate operations through
mid-2025.
Research and Development (R&D) expenses were
$11.9 million for the quarter ended June 30, 2023,
compared to $5.6 million for the quarter ended June 30,
2022. The increase in R&D expenses was primarily due to
increases of $4.0 million in preclinical and clinical costs,
driven by the initiation of the lorundrostat pivotal program in the
second quarter of 2023, $1.3 million in higher compensation
expense as a result of additions to headcount and $1.0 million
in clinical supply, manufacturing and regulatory costs.
General and Administrative (G&A) expenses were
$3.9 million for the quarter ended June 30, 2023,
compared to $0.9 million for the quarter ended June 30,
2022. The increase in G&A expenses was primarily due to
$1.4 million in higher compensation expense as a result of
additions to headcount, $1.1 million in higher professional
fees associated with operating as a public company,
$0.3 million of higher insurance expense associated with new
director and officer insurance policies and $0.2 million in
higher other administrative expenses.
Total other income was $3.6 million for the quarter ended
June 30, 2023, compared to $0.0 for the quarter ended
June 30, 2022, which was primarily attributable to interest
earned during the three months ended June 30, 2023 on the
Company’s investments in money market funds and U.S. treasuries
that began earning interest in the third quarter of 2022.
Net loss was $12.1 million for the quarter ended
June 30, 2023, compared to $6.5 million for the quarter
ended June 30, 2022. 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 Monday,
August 7, 2023. To access the call, please dial 1-877-704-4453
in the U.S. or 1-201-389-0920 outside the U.S., followed by the
conference ID: 13739672. 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 HypertensionHaving 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.
Abnormally elevated 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 LorundrostatLorundrostat 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 TherapeuticsMineralys
Therapeutics is a clinical-stage biopharmaceutical company focused
on developing medicines to target diseases driven by abnormally
elevated 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 abnormally elevated 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 StatementsMineralys
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 (ASIs) 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; 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, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
11,884 |
|
|
$ |
5,595 |
|
|
$ |
24,177 |
|
|
$ |
12,373 |
|
General and administrative |
|
3,851 |
|
|
|
884 |
|
|
|
6,496 |
|
|
|
1,675 |
|
Total operating expenses |
|
15,735 |
|
|
|
6,479 |
|
|
|
30,673 |
|
|
|
14,048 |
|
Loss from operations |
|
(15,735 |
) |
|
|
(6,479 |
) |
|
|
(30,673 |
) |
|
|
(14,048 |
) |
Interest income, net |
|
3,593 |
|
|
|
— |
|
|
|
5,922 |
|
|
|
— |
|
Other income |
|
1 |
|
|
|
— |
|
|
|
2 |
|
|
|
— |
|
Total other income, net |
|
3,594 |
|
|
|
— |
|
|
|
5,924 |
|
|
|
— |
|
Net loss |
$ |
(12,141 |
) |
|
$ |
(6,479 |
) |
|
$ |
(24,749 |
) |
|
$ |
(14,048 |
) |
Net loss per share attributable to common stockholders, basic and
diluted |
$ |
(0.31 |
) |
|
$ |
(1.26 |
) |
|
$ |
(0.77 |
) |
|
$ |
(2.73 |
) |
Weighted-average shares used to compute net loss per share
attributable to common stockholders, basic and diluted |
|
39,754,981 |
|
|
|
5,152,575 |
|
|
|
32,301,136 |
|
|
|
5,138,184 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mineralys Therapeutics, Inc. |
Selected Financial Information |
Condensed Balance Sheet Data |
(amounts in thousands) |
(unaudited) |
|
|
June 30, |
|
December 31, |
|
2023 |
|
2022 |
Cash, cash equivalents and investments |
$ |
282,775 |
|
$ |
110,110 |
|
Total assets |
$ |
291,217 |
|
$ |
114,442 |
|
Total liabilities |
$ |
6,207 |
|
$ |
8,067 |
|
Total stockholders’ equity (deficit) |
$ |
285,010 |
|
$ |
(52,269 |
) |
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