- Announced topline results from STS101 SUMMIT Phase 3 efficacy trial that the company believes demonstrate STS101 provides differentiated, robust and sustained anti-migraine effects -
- Submitted STS101 New Drug Application (NDA) to
- Company seeking to maximize value for stockholders via strategic transaction -
- ~36% workforce reduction to be implemented effective
-
“After having had the opportunity to review complete results from the SUMMIT trial, discuss them with headache specialists, and undertake further qualitative and quantitative primary market research that takes into account the results of the SUMMIT trial, we continue to believe that STS101, if approved, could be a differentiated and important treatment option for many people with migraine,” stated
“In parallel with our efforts to conclude a strategic transaction, we have implemented necessary cost-saving initiatives, including the workforce reduction announced today. While it’s difficult to part company with committed employees who have made significant contributions to Satsuma and its STS101 development efforts, given the challenging environment we face, it’s imperative that we optimally position Satsuma and STS101 to maximize potential value for our stockholders. I thank and recognize all of our employees for their commitment and hard work over the past six-plus years in taking STS101 from an abstract concept to an NDA-stage product candidate that has the potential to address the unmet needs of many people with migraine.”
Recent Business Highlights
STS101 New Drug Application (NDA) Submitted to FDA
- Earlier this month, Satsuma submitted an NDA to the FDA seeking approval of STS101 for the acute treatment of migraine with or without aura in adults. As has been its longstanding plan, the company is seeking FDA approval under the 505(b)(2) regulatory pathway that allows for referencing of some of the information required for STS101 approval from studies not conducted by Satsuma. The FDA has 60 days to conduct a preliminary review of the NDA to determine and notify the company as to whether the NDA is sufficiently complete for it to perform a complete review.
STS101 SUMMIT Phase 3 Efficacy Trial Results
- In
November 2022 , Satsuma announced topline data from its 1,591-subject, double-blind, placebo controlled STS101 SUMMIT Phase 3 efficacy trial. Although single-dose treatment of subjects’ migraine attacks with STS101 demonstrated numerical superiority versus placebo on the SUMMIT trial co-primary outcome measures, freedom from pain and freedom from most-bothersome-symptom (from among photophobia, phonophobia and nausea) assessed at the two-hour post-administration regulatory timepoint, the difference did not reach statistical significance (p<0.05). - STS101 was, however, statistically superior (p<0.001) to placebo on the freedom from pain and most-bothersome-symptom endpoints by three hours post-administration and at all subsequent timepoints (4, 6, 12, 24 and 48 hours). Additionally, STS101 was statistically superior to placebo on multiple key secondary endpoints, including pain relief at 2 hours post-administration and all timepoints thereafter and total migraine freedom at 3 hours post-administration and all timepoints thereafter. The company believes the results of the SUMMIT trial convincingly demonstrate that a single dose of STS101 provides differentiated, robust and sustained anti-migraine effects.
- STS101 was safe and well-tolerated, consistent with clinical trial experience to date.
- Based on previous interactions with the FDA, Satsuma believes that the efficacy results of the SUMMIT trial, which were not required by the FDA to support the STS101 NDA filing and its potential approval, provide a totality of evidence supporting the efficacy of STS101 for the acute treatment of migraine. The company further believes that ST101, if approved, can address the unmet needs of many people with migraine, and that the efficacy results from the SUMMIT trial, if included in the STS101 labeling approved by the FDA, would provide important treatment information to physicians and patients.
STS101 ASCEND Phase 3 Long-term, Open-label Safety Trial
- In
January 2023 , the Company completed the STS101 ASCEND Phase 3 long-term safety trial, the primary goal of which was to establish the local nasal safety profile of STS101 following repeated administration over time. STS101 was safe and well-tolerated, consistent with clinical experience to date, and final results from the trial were similar to previously-reported interim results, with no new safety signals identified. - Final results include data from more than 150 subjects who treated their migraines with STS101* for more than six month and 50 subjects who treated their migraines with STS101* for more than 12 months, satisfying the long-term safety exposure requirements previously communicated to Satsuma by the FDA. Based on its communications with the FDA, the Company believes the results from the 12-month cohort are not required to support the NDA filing and approval, but as previously agreed with the FDA, the company plans to submit these results to the STS101 NDA at the 120-Day Safety Update.
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* STS101 incorporating the improved, second-generation nasal delivery device.
Business update
- As previously announced, Satsuma does not intend to independently commercialize STS101 and is seeking to maximize value for stockholders via a strategic transaction.
Upcoming Events and Milestones
- Three poster presentations featuring interim analyses from the STS101 ASCEND Phase 3 open-label, long-term safety study at the
American Academy of Neurology (AAN) Annual Meeting, which is being heldApril 22-27 inBoston, MA and virtually - Potential acceptance of the STS101 NDA in
May 2023 - Multiple abstracts submitted for presentation at the
American Headache Society (AHS) 65th Annual Scientific Meeting, which is being heldJune 15-18 inAustin, TX - Potential marketing approval of STS101 by
January 2024
Financial results for the fourth quarter and full-year of 2022
Net losses for the fourth quarter and full year 2022 were
Research and development expenses were
Impairment loss was
General and administrative expenses were
Satsuma has implemented cost reduction initiatives, including a reduction in force, effective
About
Satsuma is headquartered in
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements concerning the business, operations and financial performance and condition of
INVESTOR AND CORPORATE CONTACTS:
212-915-2577
cdavis@lifesciadvisors.com
Tom O’Neil, Chief Financial Officer
tom@satsumarx.com
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except share and per share data)
(unaudited)
Three Months Ended | Year Ended | |||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
Operating expenses | ||||||||||||||||
Research and development | $ | 8,698 | $ | 11,866 | $ | 44,092 | $ | 37,635 | ||||||||
General and administrative | 3,165 | 3,694 | 15,126 | 13,531 | ||||||||||||
Impairment loss | 11,729 | — | 11,729 | — | ||||||||||||
Total operating expenses | $ | 23,592 | $ | 15,560 | $ | 70,947 | $ | 51,166 | ||||||||
Loss from operations | (23,592 | ) | (15,560 | ) | (70,947 | ) | (51,166 | ) | ||||||||
Interest income | 462 | 33 | 905 | 157 | ||||||||||||
Interest expense | — | (24 | ) | (13 | ) | (163 | ) | |||||||||
Net loss | $ | (23,130 | ) | $ | (15,551 | ) | $ | (70,055 | ) | $ | (51,172 | ) | ||||
Unrealized (loss) gain on marketable securities | 33 | (30 | ) | 12 | (71 | ) | ||||||||||
Comprehensive loss | $ | (23,097 | ) | $ | (15,581 | ) | $ | (70,043 | ) | $ | (51,243 | ) | ||||
Net loss per share attributable to common stockholders, basic and diluted | $ | (0.70 | ) | $ | (0.49 | ) | $ | (2.19 | ) | $ | (1.75 | ) | ||||
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted | 33,130,859 | 31,532,401 | 32,024,991 | 29,174,386 |
BALANCE SHEET DATA
(in thousands)
(unaudited)
2022 | 2021 | ||||||
Balance Sheet Data: | |||||||
Cash, cash equivalents and marketable securities | $ | 52,481 | $ | 95,770 | |||
Working capital | 46,694 | 91,356 | |||||
Total assets | 54,939 | 109,832 | |||||
Debt | — | 1,080 | |||||
Accumulated deficit | (211,791 | ) | (141,736 | ) | |||
Total stockholders’ equity | 46,824 | 101,340 |
Source:
2023 GlobeNewswire, Inc., source