Marinus Pharmaceuticals Highlights Advancing Pipeline and Commercial Strategy at Investor and Analyst Event
- Estimated net product revenue of $5-5.2 million for Q3 2023 from ZTALMY
- Cash runway extended into Q4 2024 with projected cash of $170-175 million
- None.
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
Cash runway now expected into fourth quarter of 2024 with projected cash, cash equivalents and short-term investments of between
“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
Highlights from today’s presentations are summarized below.
ZTALMY®
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Company expects third quarter 2023 ZTALMY® (ganaxolone) oral suspension CV net product revenues of between
and$5 $5.2 million - Continued growth in commercial patients with approximately 140 patients active on therapy as of September 2023
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On track to meet full year 2023 expected ZTALMY net product revenues of between
and$17 $18.5 million
Ganaxolone Clinical Update
Refractory Status Epilepticus
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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
Tuberous Sclerosis Complex
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A protocol amendment for Marinus’ ongoing Phase 3 TrustTSC trial of oral ganaxolone in tuberous sclerosis complex (TSC) has been finalized
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The trial is now anticipated to enroll 128 patients and is designed to provide
90% power to detect a25% reduction in TSC-associated seizure frequency -
Total blinded discontinuation rates to date remain below
10% , with discontinuations due to somnolence less than5% - Topline data continues to be expected in mid-2024
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The trial is now anticipated to enroll 128 patients and is designed to provide
General Business and Financial Update
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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
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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
and$170 . This balance is projected to be sufficient to fund the Company’s operating expenses, capital expenditure requirements, and maintain the minimum cash balance of$175 million required under the Company’s debt facility into the fourth quarter of 2024.$15 million
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
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
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Jim DeNike
Senior Director, Investor Relations
Marinus Pharmaceuticals, Inc.
jdenike@marinuspharma.com
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Molly Cameron
Director, Corporate Communications & Investor Relations
Marinus Pharmaceuticals, Inc.
mcameron@marinuspharma.com
Source: Marinus Pharmaceuticals