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 abnormally elevated aldosterone, today announced
financial results for the quarter ending September 30, 2023,
and provided a corporate update.
“The third quarter was productive for Mineralys with ongoing
progress in our clinical development of lorundrostat, the
publication of our proof-of-concept study, Target-HTN, in the
Journal of the American Medical Association and the addition of two
new Board members. We have finalized the designs of Launch-HTN and
Explore-CKD, which we believe strengthens our ability to generate
data that will support patients’ real-world needs. We continue to
anticipate that the Phase 3 Launch-HTN and the Phase 2 Explore-CKD
trials will be initiated by the end of 2023,” stated Jon Congleton,
Chief Executive Officer of Mineralys Therapeutics.
Recent Corporate and Clinical Highlights
- Pivotal Advance-HTN
trial – The ongoing trial is evaluating the safety and
efficacy of lorundrostat for the treatment of uncontrolled
hypertension (uHTN) or resistant hypertension (rHTN), when used as
an add-on therapy to standardized background treatment of two or
three antihypertensive medications. For subjects in the Advance-HTN
trial, the treatment withdrawal component of the program has been
moved forward from week 48 of treatment in the open-label extension
trial to week 12 of Advance-HTN. This amendment was implemented to
characterize the durability of changes in blood pressure and other
pharmacodynamic measures of efficacy following the double-blind
treatment period. Due to this protocol amendment and
the Company’s current visibility into the enrollment curve, the
Company’s expectations for topline data have been revised from the
first half of 2024 to the second half of 2024.
- Open-Label Extension
Trial – In mid-2023, the Company initiated an open-label
extension trial to allow subjects to continue to receive
lorundrostat and obtain long-term safety and efficacy data. All
subjects in the pivotal hypertension program, including the
Advance-HTN and Launch-HTN trials, as well as the Explore-CKD
trial, will be given the opportunity to participate in the
extension trial.
- Late-Breaking Poster
Presented at ASN’s Kidney Week 2023 – The late-breaking
poster presented at the American Society of Nephrology’s (ASN)
Kidney Week 2023 by David Rodman, Chief Medical Officer of
Mineralys, highlighted lorundrostat’s potential as the first
precision targeted treatment for hypertension. This poster
concluded that obesity, and other obesity-associated physiological
changes, contribute to an enhanced response to lorundrostat. The
poster is titled, “Identification of a hypertensive endotype with a
median treatment effect of -32mmHg in response to the novel
aldosterone synthase inhibitor lorundrostat”.
- JAMA Published Full Data
from Target-HTN Trial – In September 2023, The Journal of
the American Medical Association (JAMA) published the results of
Target-HTN, the first in patient trial of lorundrostat in
individuals with uHTN and rHTN. This paper, authored by doctors
Laffin and Nissen at the Cleveland Clinic, reported the robust
blood pressure lowering potential of lorundrostat as well as a
favorable tolerability profile.
- Expanded Board of
Directors – Appointed Daphne Karydas and Glenn Sblendorio
to the Company’s Board of Directors, effective September 13, 2023.
Ms. Karydas and Mr. Sblendorio bring executive, financial and
operational leadership experience in biotechnology and
biopharmaceuticals markets. Ms. Karydas was appointed chairperson
of the audit committee and Mr. Sblendorio was appointed chairperson
of the compensation committee.
Key Upcoming Milestones
- Upcoming Poster
Presentation at AHA Scientific Sessions 2023 - The Company
has been selected to present a poster at the American Heart
Association (AHA) Scientific Sessions 2023, which is being held
from November 10 – 13, 2023, in Philadelphia, PA. The poster is
titled, “Lorundrostat for Treatment of Obesity-Related,
Aldosterone-Dependent Hypertension - An Endotype-Specific, Targeted
Approach to the Treatment of Uncontrolled Hypertension”.
- Phase 3 pivotal Launch-HTN
trial – In the second half of 2023, the Company remains on
track 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. Lorundrostat will be studied
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. In keeping with the objective of the trial,
to model real world treatment of uHTN and rHTN in the primary care
setting, the trial’s primary endpoint will be in-office blood
pressure measurement rather than 24-hour ambulatory blood pressure
measurement. Based on current projections, the topline data from
this trial is now expected in the second half of 2025.
- Explore-CKD Phase 2
trial – The Company expects to initiate a two-part Phase 2
clinical trial for lorundrostat in hypertensive patients with stage
2-3b CKD in the second half of 2023, with topline data expected in
the fourth quarter of 2024 to the first quarter of 2025. In
consultation with its advisors and based on the significant unmet
need, the Company has made the strategic decision to study subjects
with systolic blood pressure (BP) greater than or equal to 135mmHg,
as well as CKD with albuminuria.
- The objective in Part A is to
assess the effect of lorundrostat, alone or in combination with
dapagliflozin in subjects with uncontrolled hypertension and stage
2-3a CKD, on systolic BP, as well as albuminuria, a surrogate
endpoint that supports long-term benefit in CKD. The Company plans
to study 25mg once daily (QD) in this trial.
- The objective in Part B is to
characterize the safety and tolerability of lorundrostat in
subjects with uncontrolled hypertension and stage 3b CKD with
albuminuria. This open-label safety study will evaluate 12.5mg QD
lorundrostat with titration to 25mg QD based on pre-specified
criteria. A new key exploratory objective for Part B is to assess
the effect of lorundrostat on systolic BP.
Third Quarter
2023 Financial HighlightsCash,
cash equivalents and investments were $265.9 million as of
September 30, 2023, compared to $110.1 million as of
December 31, 2022. The Company believes that its cash, cash
equivalents and investments as of September 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
$22.5 million for the quarter ended September 30, 2023,
compared to $6.1 million for the quarter ended
September 30, 2022. The increase in R&D expenses was
primarily due to increases of $12.4 million in preclinical and
clinical costs, driven by the initiation of the lorundrostat
pivotal program in 2023, $2.3 million in clinical supply,
manufacturing and regulatory costs and $1.7 million in higher
compensation expense resulting from additions to headcount.
General and Administrative (G&A) expenses were
$3.8 million for the quarter ended September 30, 2023,
compared to $1.4 million for the quarter ended
September 30, 2022. The increase in G&A expenses was
primarily due to $1.2 million in higher professional fees
associated with operating as a public company, $0.8 million in
higher compensation expense resulting from additions to headcount,
$0.3 million of higher insurance expense associated with new
director and officer insurance policies and $0.1 million in
higher other administrative expenses.
Total other income, net was $3.5 million for the quarter
ended September 30, 2023, compared to $0.7 million for
the quarter ended September 30, 2022, which was primarily
attributable to increased interest earned on the Company’s
investments in money market funds and U.S. treasuries.
Net loss was $22.8 million for the quarter ended
September 30, 2023, compared to $6.7 million for the
quarter ended September 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 Tuesday,
November 7, 2023. To access the call, please dial
1-888-886-7786 in the U.S. or 1-416-764-8658 outside the U.S.,
followed by the conference ID: 27015887. A live webcast of the
conference call may be found here
https://viavid.webcasts.com/starthere.jsp?ei=1632661&tp_key=eecbf184d5.
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 hypertension, CKD and
other 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 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 |
|
Nine Months Ended |
|
September 30, |
|
September 30, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
22,499 |
|
|
$ |
6,059 |
|
|
$ |
46,676 |
|
|
$ |
18,432 |
|
General and administrative |
|
3,774 |
|
|
|
1,364 |
|
|
|
10,270 |
|
|
|
3,039 |
|
Total operating expenses |
|
26,273 |
|
|
|
7,423 |
|
|
|
56,946 |
|
|
|
21,471 |
|
Loss from operations |
|
(26,273 |
) |
|
|
(7,423 |
) |
|
|
(56,946 |
) |
|
|
(21,471 |
) |
Interest income, net |
|
3,513 |
|
|
|
741 |
|
|
|
9,435 |
|
|
|
741 |
|
Other income |
|
— |
|
|
|
4 |
|
|
|
2 |
|
|
|
4 |
|
Total other income, net |
|
3,513 |
|
|
|
745 |
|
|
|
9,437 |
|
|
|
745 |
|
Net loss |
$ |
(22,760 |
) |
|
$ |
(6,678 |
) |
|
$ |
(47,509 |
) |
|
$ |
(20,726 |
) |
Net loss per share
attributable to common stockholders, basic and diluted |
$ |
(0.57 |
) |
|
$ |
(1.29 |
) |
|
$ |
(1.36 |
) |
|
$ |
(4.02 |
) |
Weighted-average shares used
to compute net loss per share attributable to common stockholders,
basic and diluted |
|
39,930,748 |
|
|
|
5,181,410 |
|
|
|
34,872,287 |
|
|
|
5,152,752 |
|
Mineralys Therapeutics, Inc.Selected Financial
InformationCondensed Balance Sheet
Data(amounts in
thousands)(unaudited) |
|
|
September 30, |
|
December 31, |
|
|
2023 |
|
|
2022 |
|
Cash, cash equivalents and investments |
$ |
265,890 |
|
$ |
110,110 |
|
Total assets |
$ |
277,555 |
|
$ |
114,442 |
|
Total liabilities |
$ |
13,543 |
|
$ |
8,067 |
|
Total stockholders’ equity (deficit) |
$ |
264,012 |
|
$ |
(52,269 |
) |
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