RAISE trial enrollment trends have returned to
anticipated levels; on track for topline data in the first quarter
of 2024, assuming pre-defined stopping criteria for interim
analysis are met
Continued execution of commercial launch of
ZTALMY® (ganaxolone) with estimated net product revenue of between
$5 and $5.2 million for the third quarter of 2023
Cash runway now expected into fourth quarter of
2024 with projected cash, cash equivalents and short-term
investments of between $170 million and $175 million as of
September 30, 2023
Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical
company dedicated to the development of innovative therapeutics to
treat seizure disorders, is today hosting an Investor and Analyst
Event in New York to review the Company’s ongoing clinical-stage
programs and commercial planning activities. The event begins at 9
a.m. ET and will be available via webcast here.
“I look forward to showcasing how we are planning to deliver on
our commitment to improve the lives of more patients with
refractory seizure disorders during today’s Investor and Analyst
Event,” said Scott Braunstein, M.D., Chairman and Chief Executive
Officer of Marinus. “The presentations will offer a deep dive on
the significant progress being made advancing our late-stage
clinical programs and commercial preparation activities that we
believe could expand the treatment potential of ganaxolone into
additional disease states which have limited therapeutic
alternatives for patients today. We will also highlight the ongoing
success of our first product launch in CDKL5 deficiency disorder,
with continued growth in new commercial patients and strong payer
reimbursement.”
Dr. Braunstein continued, “Enrollment in the Phase 3 RAISE trial
in refractory status epilepticus has been on an upward trajectory
since early August following the activation of new clinical sites.
Importantly, we have extended our cash runway into the fourth
quarter of 2024 through strategic use of our existing ATM facility.
This is expected to provide us with the resources needed to
successfully execute on our two Phase 3 data readouts in RSE and
tuberous sclerosis complex and invest in the appropriate
pre-commercial activities to continue driving future growth for
Marinus.”
Rajat Dhar, M.D., Professor of Neurology in the Section of
Neurocritical care at Washington University School of Medicine in
St. Louis, Attending Physician in the Neurology/ Neurosurgery
Intensive Care Unit at Barnes-Jewish Hospital, and investigator in
the RAISE trial, who will provide an overview on the unmet need in
status epilepticus, noted, “Patients with status epilepticus often
require hospitalization and treatment as neurological emergencies,
with more than 50% unresponsive to first- or second-line therapies.
As a result, this patient population is long overdue for treatment
options that have the potential to improve morbidity and
mortality.”
Highlights from today’s presentations are summarized below.
ZTALMY®
- Company expects third quarter 2023 ZTALMY® (ganaxolone) oral
suspension CV net product revenues of between $5 and $5.2
million
- Continued growth in commercial patients with approximately 140
patients active on therapy as of September 2023
- On track to meet full year 2023 expected ZTALMY net product
revenues of between $17 and $18.5 million
Ganaxolone Clinical
Update
Refractory Status Epilepticus
- Over 70% of patients required for the interim analysis are now
enrolled in the Phase 3 RAISE trial of intravenous (IV) ganaxolone
in refractory status epilepticus
- RAISE enrollment trends have returned to anticipated levels
with enrollment for the interim analysis expected to conclude by
January 2024
- Topline data continues to be anticipated in the first quarter
of 2024, if the pre-defined stopping criteria from the planned
interim analysis are met
Ganaxolone development in the RAISE trial is being funded in
part by the Biomedical Advanced Research and Development Authority
(BARDA), part of the Administration for Strategic Preparedness and
Response at the U.S. Department of Health and Human Services, under
contract number 75A50120C00159.
Tuberous Sclerosis Complex
- A protocol amendment for Marinus’ ongoing Phase 3 TrustTSC
trial of oral ganaxolone in tuberous sclerosis complex (TSC) has
been finalized
- The trial is now anticipated to enroll 128 patients and is
designed to provide 90% power to detect a 25% reduction in
TSC-associated seizure frequency
- Total blinded discontinuation rates to date remain below 10%,
with discontinuations due to somnolence less than 5%
- Topline data continues to be expected in mid-2024
General Business and Financial
Update
- Subsequent to the financial results reported on August 10,
2023, a total of 3.7 million shares were sold through the Company’s
at-the-market (ATM) facility contributing net proceeds of $25.9
million
- ATM sales consisted of a limited number of discreet reverse
inquiry transactions from existing shareholders
- Inclusive of the proceeds from the recent ATM offering, the
Company projects cash, cash equivalents, and short-term investments
at the end of the third quarter of 2023 to be in the range of
between $170 and $175 million. This balance is projected to be
sufficient to fund the Company’s operating expenses, capital
expenditure requirements, and maintain the minimum cash balance of
$15 million required under the Company’s debt facility into the
fourth quarter of 2024.
About Marinus Pharmaceuticals
Marinus is a commercial-stage pharmaceutical company dedicated
to the development of innovative therapeutics for seizure
disorders. The Company first introduced FDA-approved prescription
medication ZTALMY® (ganaxolone) oral suspension CV in the U.S. in
2022 and continues to invest in the potential of ganaxolone in IV
and oral formulations to maximize therapeutic reach for adult and
pediatric patients in acute and chronic care settings. For more
information about Marinus visit www.marinuspharma.com.
Forward-Looking Statements
To the extent that statements contained in this press release
are not descriptions of historical facts regarding Marinus, they
are forward-looking statements reflecting the current beliefs and
expectations of management made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995.
Words such as "may", "will", "expect", "anticipate", "estimate",
"intend", "believe", and similar expressions (as well as other
words or expressions referencing future events, conditions or
circumstances) are intended to identify forward-looking statements.
Examples of forward-looking statements contained in this press
release include, among others, statements regarding our
commercialization and marketing plans for ZTALMY; our net product
revenue guidance; our expected clinical development plans,
enrollment in our clinical trials, regulatory communications and
submissions for ganaxolone, and the timing thereof; our expected
cash runway; our expectations and beliefs regarding the FDA and EMA
with respect to our product candidates; our financial projections;
the potential safety and efficacy of ganaxolone, as well as its
therapeutic potential in a number of indications; and other
statements regarding the company's future operations, financial
performance, financial position, prospects, objectives and other
future event.
Forward-looking statements in this press release involve
substantial risks and uncertainties that could cause our clinical
development programs, future results, performance or achievements
to differ significantly from those expressed or implied by the
forward-looking statements. Such risks and uncertainties include,
among others, unexpected market acceptance, payor coverage or
future prescriptions and revenue generated by ZTALMY; the pricing
and reimbursement process can be time consuming and may delay
commercialization of ZTALMY in one or more European countries; our
dependence on Orion to commercialize ZTALMY in Europe pursuant to
the exclusive collaboration agreement; unexpected actions by the
FDA or other regulatory agencies with respect to our products;
competitive conditions and unexpected adverse events or patient
outcomes from being treated with ZTALMY, uncertainties and delays
relating to the design, enrollment, completion, and results of
clinical trials; unanticipated costs and expenses; the company’s
cash and cash equivalents may not be sufficient to support its
operating plan for as long as anticipated; our ability to comply
with the FDA’s requirement for additional post-marketing studies in
the required time frames; the timing of regulatory filings for our
other product candidates; clinical trial results may not support
regulatory approval or further development in a specified
indication or at all; actions or advice of the FDA or EMA may
affect the design, initiation, timing, continuation and/or progress
of clinical trials or result in the need for additional clinical
trials; the size and growth potential of the markets for the
company’s product candidates, and the company’s ability to service
those markets; the company’s expectations, projections and
estimates regarding expenses, future revenue, capital requirements,
and the availability of and the need for additional financing;
delays, interruptions or failures in the manufacture and supply of
our product candidates; the company’s ability to obtain additional
funding to support its clinical development and commercial
programs; the company’s ability to protect its intellectual
property; and the effect of the COVID-19 pandemic on our business,
the medical community, regulators and the global economy. This list
is not exhaustive and these and other risks are described in our
periodic reports, including our annual reports on Form 10-K,
quarterly reports on Form 10-Q and current reports on Form 8-K,
filed with or furnished to the Securities and Exchange Commission
and available at www.sec.gov. Any forward-looking statements that
we make in this press release speak only as of the date of this
press release. We assume no obligation to update forward-looking
statements whether as a result of new information, future events or
otherwise, after the date of this press release.
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version on businesswire.com: https://www.businesswire.com/news/home/20230919276800/en/
Company
Investors Jim DeNike Senior
Director, Investor Relations Marinus Pharmaceuticals, Inc.
jdenike@marinuspharma.com
Media Molly Cameron Director,
Corporate Communications & Investor Relations Marinus
Pharmaceuticals, Inc. mcameron@marinuspharma.com
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