Loading...
•
Jun 30, 2020
Marinus Pharmaceuticals Q2 2020 Earnings Report
Reported financial results for the second quarter ended June 30, 2020.
Key Takeaways
Marinus Pharmaceuticals reported a net loss of $15.7 million for the second quarter of 2020, with research and development expenses increasing to $11.8 million. The company's cash, cash equivalents, and investments totaled $105.9 million as of June 30, 2020.
Clinical programs continue to progress in line with current timelines.
Topline data from the pivotal Phase 3 clinical trial in CDKL5 deficiency disorder is expected in the third quarter.
Planning for first NDA submission and potential commercial launch of ganaxolone.
FDA granted Rare Pediatric Disease Designation for ganaxolone in CDD.
Marinus Pharmaceuticals
Marinus Pharmaceuticals
Forward Guidance
Marinus Pharmaceuticals is focused on advancing its clinical development programs, including ganaxolone, and preparing for potential commercialization. The company anticipates releasing topline data from its Phase 3 trial in CDKL5 deficiency disorder in Q3 2020 and initiating a Phase 3 trial in status epilepticus in Q3 2020.
Positive Outlook
- Expectations to release topline data from the pivotal Phase 3 Marigold Study in the third quarter of 2020.
- Expectations to initiate a Phase 3 trial in status epilepticus in the third quarter of 2020.
- Expectations to release topline data from our Phase 3 trial in status epilepticus in the first half of 2022.
- Expectations regarding the enrollment of our Phase 2 open-label trial for patients with TSC.
- Expectations to release topline data from our Phase 2 open-label trial for patients with TSC in the first half of 2021.
Challenges Ahead
- Uncertainties and delays relating to the design, enrollment, completion, and results of clinical trials
- Unanticipated costs and expenses
- Early clinical trials may not be indicative of the results in later clinical trials
- Clinical trial results may not support regulatory approval or further development in a specified indication or at all
- Actions or advice of the U.S. Food and Drug Administration may affect the design, initiation, timing, continuation and/or progress of clinical trials or result in the need for additional clinical trials