0000000000-19-012307.txt : 20191010 0000000000-19-012307.hdr.sgml : 20191010 20190812124328 ACCESSION NUMBER: 0000000000-19-012307 CONFORMED SUBMISSION TYPE: UPLOAD PUBLIC DOCUMENT COUNT: 2 FILED AS OF DATE: 20190812 FILED FOR: COMPANY DATA: COMPANY CONFORMED NAME: Satsuma Pharmaceuticals, Inc. CENTRAL INDEX KEY: 0001692830 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 813039831 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: UPLOAD BUSINESS ADDRESS: STREET 1: 400 OYSTER POINT BOULEVARD STREET 2: SUITE 221 CITY: SOUTH SAN FRANCISCO STATE: CA ZIP: 64080 BUSINESS PHONE: 415-505-0809 MAIL ADDRESS: STREET 1: 400 OYSTER POINT BOULEVARD STREET 2: SUITE 221 CITY: SOUTH SAN FRANCISCO STATE: CA ZIP: 64080 LETTER 1 filename1.pdf begin 644 filename1 M)5!$1BTQ+C4-)>+CS],-"C$Q(# @;V)J#3P\+TQI;F5A%LP(# @-C$R(#7!E+U!A9V4^ M/@UE;F1O8FH-,30@,"!O8FH-/#PO1FEL=&5R+T9L871E1&5C;V1E+T9I5I]@1^9 /] M1P&$,83A I("WHEBX\"-A(?9P^QI]GX]P[U%X,(ZG=EPC6?QX>.ZV:2?"U]P M_=/Y]T!7G$:N PO;0MG!PO)@7W3K@H*!L-O]C_0\)Z1WU0H?.^L'@Y++> MU+J"^ I]/0!OZ26F]='YGA1I8[;<9E=2Z+="%T7"L>"/PBMR5\E7DN M2CWF""\%\6)PY5YQ+5)>5L#*%#YL!<_@XP^>U)78<[C+,I%P-2TKT(*>2OP FL82J\( MGIX8QXZL!0IRO$.;C!C3[P5MY,^Q0+W*JU+!KG[,19(? 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Amendment No. 1 to Draft Registration Statement on Form S-1 Submitted August 2, 2019 CIK No. 0001692830 Dear Mr. Kollins: We have reviewed your amended draft registration statement and have the following comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. Please respond to this letter by providing the requested information and either submitting an amended draft registration statement or publicly filing your registration statement on EDGAR. If you do not believe our comments apply to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing the information you provide in response to these comments and your amended draft registration statement or filed registration statement, we may have additional comments. Amendment No. 1 to Draft Registration Statement on Form S-1 submitted August 2, 2019 Prospectus Summary Overview, page 1 1. We note your revised disclosure in response to prior comment 3 and your graphs on pages 96 and 99. Regarding the comparisons made in the first bullet point on page 2, please tell us whether the liquid nasal form is the only FDA approved dosage form that demonstrated lower exposure levels as compared to STS101. If it is the only one, then please identify it in your disclosure. Also, tell us whether the term "exposure levels" references measurements at multiple points in time following administration and what "range" or "ranges" demonstrated efficacy in other forms. With reference to prior comment 5, please John Kollins Satsuma Pharmaceuticals, Inc. August 9, 2019 Page 2 also tell us why the final clause appears to compare "exposure levels" to "peak concentration levels." Risk Factors Our success depends on our ability to protect our intellectual property..., page 33 2. We note your revised disclosure in response to our prior comment 17; however, your disclosure at the bottom of page 33 continues to indicate that all of your patent portfolio is "solely owned." Accordingly, please revise the risk factor to reflect that all of your issued US and foreign patents relating to STS101 are licensed from SNBL. Business Overview, page 85 3. We note your revised disclosure on page 86 in response to prior comment 10. Please revise to discuss and quantify the rapid and high peak DHE plasma concentrations that are believed to be associated with adverse side effects. Also revise to clarify whether you share this belief. Safety and Tolerability, page 96 4. Your disclosure added in response to our prior comment 13 identifies nasal adverse events as the most frequent adverse events reported in connection with STS101 administration. Please expand this section to identify all reported adverse events and not just the most frequent ones. In particular, your disclosure should address any reports of nausea and vomiting given your disclosures on pages 2 and elsewhere concerning the key attributes of STS101 relative to existing DHE products. Phase 3 Efficacy Trial, page 101 5. We note your revised disclosure in response to prior comment 16. With reference to FirstName LastNameJohn Kollins pages 2 and 7 of the FDA Guidance Migraine: Developing Drugs for Acute Treatment, Comapany NameSatsuma Pharmaceuticals, Inc.if applicable, to indicate whether you will be February 2018, please tell us, and revise Augustconducting pediatric studies. 9, 2019 Page 2 FirstName LastName John Kollins FirstName LastNameJohn Inc. Satsuma Pharmaceuticals, Kollins Comapany2019 August 9, NameSatsuma Pharmaceuticals, Inc. Page 3 August 9, 2019 Page 3 FirstName LastName You may contact Mark Brunhofer at 202-551-3638 or Jim Rosenberg at 202-551-3679 if you have questions regarding comments on the financial statements and related matters. Please contact Irene Paik at 202-551-6553 or Joe McCann at 202-551-6262 with any other questions. Sincerely, Division of Corporation Finance Office of Healthcare & Insurance cc: Brian J. Cuneo - Latham & Watkins LLP