South San Francisco, CA, April 28, 2020 – Satsuma Pharmaceuticals, Inc. (Nasdaq: STSA), a clinical-stage biopharmaceutical company, announced today that it will host a Key Opinion Leader (KOL) event discussing STS101 and the acute treatment of migraine on Tuesday, May 5, 2020 at 12:00pm Eastern Time.
The event will feature presentations by headache medicine specialists Jessica Ailani, MD, from Medstar Georgetown Headache Center, and Alan Rapoport, MD, from The David Geffen School of Medicine at UCLA, addressing the current treatment landscape for the acute treatment of migraine, unmet needs, and potential roles for Satsuma’s product candidate, STS101. As well, Satsuma's Chief Medical Officer, Detlef Albrecht, MD, will review the design of the ongoing STS101 EMERGE™ Phase 3 pivotal efficacy and safety trial. Following presentations, Drs. Ailani, Rapoport, Albrecht and members of Satsuma’s management team will be available to answer questions from the audience.
STS101 is an investigational product designed to make the well-established anti-migraine benefits of dihydroergotamine (DHE) more broadly accessible to people with migraine. STS101 is a simple-to-use, nasal-route DHE product featuring easy and quick self-administration (within a matter of seconds) and a pharmacokinetic profile similar to DHE administered by intramuscular injection, which Satsuma believes is necessary for achieving optimal DHE efficacy. In developing STS101, Satsuma has applied proprietary nasal drug delivery, dry-powder formulation, and engineered drug particle technologies to create a compact, pre-filled and ready-to-administer non-injectable DHE product candidate that it believes could, if approved, better meet the needs of people with migraine than current and development-stage DHE products. STS101 has undergone extensive preclinical development, completed a Phase 1 clinical trial, and is currently in Phase 3 development.
Tuesday, May 5, 2020 at 12:00pm Eastern Time
Conference ID: 13702842
Webcast: Click here for Webcast
Jessica Ailani, MD, is a Professor of Clinical Neurology and Director of the Medstar Georgetown Headache Center at MedStar Georgetown University Hospital in Washington, DC. She received her medical degree from the Stony Brook University School of Medicine in New York, followed by an internship at Winthrop University Hospital in Mineola, New York. Dr. Ailani subsequently completed a residency and Chief Residency in Neurology at NYU Langone Medical Center in New York, New York, followed by a fellowship in Headache Medicine at Thomas Jefferson University in Philadelphia, Pennsylvania. She is board-certified in Neurology with subspecialty certification in Headache Medicine.
Dr. Ailani is a fellow of the American headache society and of the American Academy of Neurology. She holds a position on the board of the American Headache Society as a member at large. For AHS, Dr. Ailani is a co-chair of the Practice management committee and is on the scientific and Scottsdale program planning committees. Dr. Ailani is Section Editor of Unusual Headache Syndromes for Current Pain and Headache Reports and a reviewer for several professional journals. Dr. Ailani has presented nationally on topics surrounding headache medicine.
Alan Rapoport, MD is a Clinical Professor of Neurology at The David Geffen School of Medicine at UCLA, Los Angeles, California, where he teaches medical students, neurology residents and fellows. He is a Past President of the International Headache Society (IHS) and the founder and Director-Emeritus of The New England Center for Headache, in Stamford, Connecticut. Board-certified in Neurology and Headache Medicine, he has co-authored more than 300 articles,10 books, as well as multiple chapters and posters on headache and other neurological diseases.
Dr. Rapoport is the Co-Founder and CEO of BonTriage, an IT company in Silicon Valley, California, dedicated to helping patients and doctors around the globe by collecting detailed patient histories on line and linking with an app that monitors patient progress and outcomes. Dr. Rapoport has served on the Board of Directors of the American Headache Society (AHS) and is the immediate past President of the Fairfield County Neurological Society (Connecticut), the Founding President of the Headache Cooperative of New England (HCNE), the Founding Director of the Headache Cooperative of the Pacific (HCOP). He is the director of the headache day at the annual Controversies in Neurology (CONy) which was held in Madrid in 2019 and will be held in London in October 2020.
About Satsuma Pharmaceuticals and STS101
Satsuma Pharmaceuticals is a clinical-stage biopharmaceutical company developing a novel therapeutic product for the acute treatment of migraine, STS101. STS101 is a drug-device combination of a proprietary dry-powder formulation of dihydroergotamine mesylate (DHE), which can be quickly and easily self-administered with a proprietary pre-filled, single-use, nasal delivery device. In developing STS101, Satsuma has applied proprietary nasal drug delivery, dry-powder formulation, and engineered drug particle technologies to create a compact, simple-to-use, non-injectable DHE product that can be rapidly self-administered in a matter of seconds. The Company believes STS101 would, if approved, be an attractive migraine treatment option for many patients and may enable a larger number of people with migraine to realize the long-recognized therapeutic benefits of DHE therapy. STS101 has undergone extensive pre-clinical development, completed a Phase 1 clinical trial, and is currently in Phase 3 development.
Satsuma is headquartered in South San Francisco, California with operations in both California and Research Triangle Park, North Carolina. For further information, please visit www.satsumarx.com.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements concerning the business, operations and financial performance and condition of Satsuma Pharmaceuticals, Inc. (the “Company”), as well as the Company’s plans, objectives and expectations for its business operations and financial performance and condition. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “should,” “target,” “will,” “would,” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to, statements about the Company’s expectations regarding the potential safety and efficacy of STS101; the potential benefits of STS101, if approved; and the likelihood of regulatory filings and approvals for STS101. In light of these risks and uncertainties, the events or circumstances referred to in the forward-looking statements may not occur. The Company’s actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to, risks detailed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, filed with the Securities and Exchange Commission, as well as other documents that 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 demonstrate sufficient evidence of efficacy and safety in its clinical trials of STS101; the results of preclinical and clinical studies may not be predictive of future results; the risk that the COVID-19 worldwide pandemic may negatively impact the development of STS101; the unpredictability of the regulatory process; regulatory developments in the United States and foreign countries; the costs of clinical trials may exceed expectations; and the Company’s ability to raise additional 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 be achieved or occur, and the timing of events and circumstances and actual results could differ materially from those projected in the forward-looking statements. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
This press release discusses STS101, a product candidate that is in clinical development, and which has not yet been approved for marketing by the U.S. Food and Drug Administration. No representation is made as to the safety or effectiveness of STS101 for the therapeutic use for which STS101 is being studied.
INVESTOR AND CORPORATE CONTACTS:
Corey Davis, PhD
LifeSci Advisors, LLC
Tom O’Neil, Chief Financial Officer
Satsuma Pharmaceuticals, Inc.