Satsuma Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, today summarized recent business progress and reported financial results for the second quarter ended June 30, 2020.
“As evidenced by the completion of the treatment phase of our Phase 3 EMERGE efficacy trial and the recent initiation of patient enrollment in our Phase 3 open-label ASCEND safety trial, we continue to execute our STS101 development program according to plan,” commented John Kollins, Satsuma’s President and Chief Executive Officer. “We expect to announce EMERGE trial topline results in the near future, and we anticipate the results, if successful, will position STS101 to become an important and differentiated acute treatment option for people with migraine.”
EMERGE Phase 3 efficacy trial
As reported in early June, Satsuma completed enrollment in the EMERGE efficacy trial with more than the planned 1,140 migraine patients randomized to one of two STS101 dosage strengths or placebo. Following randomization, patients had 56 days in which to treat a single qualifying migraine attack of at least moderate pain severity with study medication. As of July 30, all patients had completed the treatment phase of the trial. The Company is on track to report topline data in late September or early October of this year.
ASCEND Phase 3 open-label long-term safety trial
Last week, Satsuma initiated patient enrollment in the ASCEND open-label safety trial in which patients will treat their migraines on an as-needed basis with STS101 for up to 12 months. The trial is expected to enroll up to 300 migraine patients, with at least 150 treating a minimum of two attacks per month with STS101 over a six-month period and at least 50 over a 12-month period.
Virtual Scientific Meeting Presentations
In May, Satsuma announced that two scientific presentations were selected for the 2020 American Academy of Neurology Science Highlights Virtual Platform:
- Water-insoluble Mucoadhesive Formulation Enables Consistent and Rapid Intranasal Absorption of Drugs, including Granisetron, Zolmitriptan and Dihydroergotamine
- PK Comparison of STS101, an Intranasal Dry Powder Formulation of Dihydroergotamine, with Other Intranasal, Injectable and Oral Inhaled DHE Formulations
In June, Satsuma virtually presented two posters at the 2020 American Headache Society Annual Scientific Meeting:
- Safety of Dihydroergotamine for the Acute Treatment of Migraine: Reality vs. Perception
- The Efficacy of Dihydroergotamine versus Emerging Acute Migraine Medications
Copies of these poster presentations are available for download in the publications section of Satsuma’s website: www.satsumarx.com/publications.
Addition to the Board of Directors
In July, Satsuma appointed biopharmaceutical industry veteran Thomas M. Soloway to its Board of Directors. Mr. Soloway currently serves as Executive Vice President and Chief Operating Officer of Audentes Therapeutics Inc., an Astellas genetic medicines company committed to developing and commercializing innovative gene therapy products for patients living with rare, life-threatening diseases.
Expansion of Intellectual Property Portfolio
Satsuma continues to expand its intellectual property portfolio, with notices of claims allowance recently received from the United States Patent and Trademark Office (USPTO) for two pending patent applications licensed or owned by Satsuma. The Company anticipates the pending applications will issue around the end of this year and, when issued, will have estimated expiration dates in 2037 and 2039 (not taking into account any adjustments or extensions of term). When the pending patents issue, they will bring the total number of issued U.S. patents owned or licensed by Satsuma to ten, reflecting the highly innovative and differentiated nature of the proprietary dry-powder nasal delivery and formulation technologies incorporated in STS101.
Financial Results for Second Quarter 2020
Net loss for the second quarter 2020 was $11.3 million, or $0.65 per share of common stock, compared to a net loss of $6.3 million, or $5.48 per share of common stock, for the same period in 2019. As of June 30, 2020, the Company had $93.7 million of cash, cash equivalents and marketable securities. The Company believes it has sufficient financial resources to fund operations through the end of 2021.
Research and development expenses were $8.8 million for the second quarter 2020, compared to $5.5 million for the same period of 2019. Second quarter expenses increased by $3.3 million, primarily due to additional expenses for the EMERGE clinical trial activities, development and production of clinical trial materials, as well as increases in salaries and employee-related expenses.
General and administrative expenses were $2.7 million for the second quarter 2020, compared to $1.0 million for the same period of 2019. Second quarter expenses increased by $1.7 million, primarily due to an increase of $0.9 million of director and officer liability insurance, professional fees for legal, consulting, accounting, tax and other services and an increase of $0.8 million of payroll and personnel expenses, including salaries, benefits and stock-based compensation expenses, due to increase in headcount. – BioSpace