Satsuma Pharmaceuticals Announces Acceptance of Abstracts

SOUTH SAN FRANCISCO, Calif., March 03, 2022 (GLOBE NEWSWIRE) — Satsuma Pharmaceuticals, Inc. (Nasdaq: STSA), a clinical-stage biopharmaceutical company, developing STS101 (dihydroergotamine (DHE) nasal powder), a novel investigational therapeutic product candidate for the acute treatment of migraine, announced today that four abstracts highlighting STS101 and its distinguishing features have been selected for presentation and will be presented at the 2022 American Academy of Neurology (AAN) Annual Meeting, April 2-7, 2022. Full abstracts are now available on the AAN website.

title: Pharmacokinetics and Safety of STS101, a Novel DHE Powder Drug Combination Trial in Healthy Volunteers
abstract: 521
poster
presentation #:
P13.2-003
meeting: P13: headache: migraine therapeutics 3rd
Time: Wednesday, April 6, 2022 from 8:00 a.m. – 9:00 a.m. Pacific Time
title: Pharmacokinetic comparison of STS101 (a novel investigational DHE nasal powder) with liquid nasal, injectable and orally inhaled DHE formulations
abstract: 516
poster
presentation #:
P13.2-004
meeting: P13: headache: migraine therapeutics 3rd
Time: Wednesday, April 6, 2022 from 8:00 a.m. – 9:00 a.m. Pacific Time
title: Long-term safety and tolerability of STS101, a novel investigational dihydroergotamine nasal powder: Initial data from the ASCEND study
abstract: 520
poster
presentation #:
P13.2-002
meeting: P13: headache: migraine therapeutics 3rd
Time: Wednesday, April 6, 2022 from 8:00 a.m. – 9:00 a.m. Pacific Time
title: Cardiovascular Safety of STS101, a Novel DHE Nasal Powder Investigational Product: Initial Data from the ASCEND Study
abstract: 517
poster
presentation #:
P14.2-006
meeting: P14: headache: migraine therapeutics 4th
Time: Wednesday, April 6, 2022 from 11:45 a.m. – 12:45 p.m. Pacific Time

About Satsuma Pharmaceuticals and STS101

Satsuma Pharmaceuticals is a clinical-stage biopharmaceutical company developing a novel therapeutic product, STS101, for the acute treatment of migraine. STS101 is a unique and proprietary powder formulation of the proven anti-migraine drug dihydroergotamine mesylate (DHE) delivered via Satsuma’s proprietary nasal delivery device. STS101 is designed to offer significant advantages over existing acute treatments for migraine, including the combination of rapid and convenient self-administration and other clinical benefits that current liquid DHE nasal spray products and injectable dosage forms lack. Satsuma’s dry powder DHE formulation has rapid absorption, rapid attainment of high DHE plasma concentrations, which Satsuma believes are necessary for early efficacy, and sustained plasma levels over time with low dose-to-dose variability shown. STS101 now also includes an improved second generation nasal delivery device designed to provide more consistent nasal dosing regardless of the user’s delivery technique. Although DHE has long been recommended as the first-line acute treatment option for migraine in published migraine treatment guidelines and offers significant benefits over other anti-migraine treatments for many patients, current liquid DHE nasal sprays and injectable products have drawbacks, including being invasive and burdensome Methods of administration and/or suboptimal clinical performance have limited the widespread use of DHE. With a compact and convenient delivery form, STS101 was designed to overcome these shortcomings and provide patients with an improved therapeutic solution for the acute management of migraine that consistently delivers robust clinical performance.

Satsuma is headquartered in South San Francisco, California with offices in California and Research Triangle Park, North Carolina. Visit www.satsumarx.com for more information.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements about the business, operations and financial performance and condition of Satsuma Pharmaceuticals, Inc. (the “Company”) and the Company’s plans, goals and expectations for its operations and financial performance and condition. All statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. In some cases, you can use words such as “target”, “anticipate”, “assume”, “believe”, “consider”, “continue”, “may”, “due”, “estimate”, “expect” forward-looking statements ‘, ‘goal’, ‘intend’, ‘may’, ‘objective’, ‘plan’, ‘predict’, ‘potential’, ‘positioned’, ‘aim’, ‘should’, ‘aim’, ‘will’, “would” and other similar expressions that are or indicate predictions of future events and future trends, or the negative of these terms or other similar terminology. These forward-looking statements include, among other things, statements about the Company’s expectations regarding the potential safety and efficacy of STS101, the potential results of the ASCEND and SUMMIT studies, the timing of initiation and data readout for ongoing and planned clinical trials, the expected timing for a potential NDA filing of STS-101, the potential of STS-101 as an important and differentiated treatment option for acute cases, and the Company’s anticipated cash flow development. Given these risks and uncertainties, the events or circumstances discussed in the forward-looking statements may not occur. The company’s actual results could differ based on a number of factors, including but not limited to risks discussed in the company’s quarterly report on Form 10-Q for the May 30 , filed with the Securities and Exchange Commission and other documents from time to time may be filed by the Company from time to time. In particular, the following factors, among others, could cause results to differ materially from those expressed or implied by such forward-looking statements: the Company’s ability to generate sufficient evidence of efficacy and safety in its clinical trials of STS101; the results of preclinical and clinical studies may not be indicative of future results; and the risk that the global COVID-19 pandemic could adversely affect the Company’s business, operations, clinical trials or ability to raise capital. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the events and circumstances reflected in the forward-looking statements will or will occur, the timing of events and circumstances and actual results may differ materially from those projected in the forward-looking statements. Accordingly, you should not place undue reliance on these forward-looking statements. All of these statements speak only as of the date on which they are made, and the Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

This press release addresses STS101, a product candidate in clinical development that has not yet been approved for marketing by the US Food and Drug Administration. No claims are made regarding the safety or efficacy of STS101 for the therapeutic use for which STS101 is being investigated.

CONTACTS FOR INVESTORS AND COMPANIES:

Corey Davis, Ph.D
LifeSci Advisors, LLC
[email protected]

Tom O’Neil, Chief Financial Officer
Satsuma Pharmaceuticals, Inc.
[email protected]