0000000000-19-014479.txt : 20191129 0000000000-19-014479.hdr.sgml : 20191129 20191010145604 ACCESSION NUMBER: 0000000000-19-014479 CONFORMED SUBMISSION TYPE: UPLOAD PUBLIC DOCUMENT COUNT: 2 FILED AS OF DATE: 20191010 FILED FOR: COMPANY DATA: COMPANY CONFORMED NAME: Oyster Point Pharma, Inc. CENTRAL INDEX KEY: 0001720725 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 811030955 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: UPLOAD BUSINESS ADDRESS: STREET 1: 202 CARNEGIE CENTER STREET 2: SUITE 109 CITY: PRINCETON STATE: NJ ZIP: 08540 BUSINESS PHONE: (609) 382-9032 MAIL ADDRESS: STREET 1: 202 CARNEGIE CENTER STREET 2: SUITE 109 CITY: PRINCETON STATE: NJ ZIP: 08540 PUBLIC REFERENCE ACCESSION NUMBER: 0001193125-19-262771 LETTER 1 filename1.pdf begin 644 filename1 M)5!$1BTQ+C4-)>+CS],-"CD@,"!O8FH-/#PO3&EN96%R:7IE9" Q+TP@,S0V M,#DO3R Q,2]%(#(X,C7!E+UA2968O5ULQ(#(@,5T^/G-T('$U_4,3(P,,T!*&!B9_C/N_@\08 "/B@?@ M#0IE;F1S=')E86T-96YD;V)J#7-T87)T>')E9@T*, T*)25%3T8-"B @(" @ M(" @#0HQ.2 P(&]B:@T\/"]&:6QT97(O1FQA=&5$96-O9&4O22 X,R],96YG M=&@@-S O4R T.#X^^!-",020,$& #2D@I[ M#0IE;F1S=')E86T-96YD;V)J#3$P(# @;V)J#3P\+TUE=&%D871A(#,@,"!2 M+U!A9V5S(#<@,"!2+U1Y<&4O0V%T86QO9SX^#65N9&]B:@TQ,2 P(&]B:@T\ M/"]#;VYT96YT%LP(# @-C$R(#,C17,% PM% P-U&P ML=%W2BQ.=%#(, @P 8!0VPPT*96YD)S-5DUSVS80O>M7[%&=L1B"W^HMC>-.+Q\5OFP6^BT,/-MG"A17NQ1\?-^U+^GCP&==_/W_NZ AK M[3*(70=MA['CPZ9I!:&#N%7@N M6W^OZ)! 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Registration Statement on Form S-1 Filed October 4, 2019 File No. 333-234104 Dear Dr. Nau: We have reviewed your 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 amending your registration statement and providing the requested information. 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 any amendment to your registration statement and the information you provide in response to these comments, we may have additional comments. Unless we note otherwise, our references to prior comments are to comments in our September 16, 2019 letter. Registration Statement on Form S-1 Prospectus Summary Overview, page 1 1. We note your response to comment 1. Throughout your registration statement you state that you are not aware of any other therapy that has demonstrated statistically significant improvements in both signs and symptoms of DED in a single registrational clinical trial. Please revise to clarify, if true, that you did not test any other products or therapies in this specific trial and that there are no head-to-head results providing support that another product candidate, product or therapy could not have shown similar results in the specific clinical trial you reference. 2. We note your response to comment 4 that you do not expect to continue to pursue FDA Jeffrey Nau Oyster Point Pharma, Inc. October 10, 2019 Page 2 approval of OC-02 for the treatment of dry eye disease. If true, please revise throughout to clarify that you do not intend to pursue FDA approval for OC-02 for the treatment of dry eye disease. Business Our Product Candidates, page 89 3. Please revise your pipeline chart to indicate the therapeutic area for OC-02. In addition, please tell us what you mean by "oral indication" in the chart as your disclosure on page 99 states that OC-02 was studied as a nasal spray in a Phase 2b clinical study, the PEARL study, for dry eye disease. To the extent that you intend to file an IND for OC-02 in a different indication, please revise the chart to indicate that OC-02 is still in the preclinical stage for that indication. Similarly, please revise to chart to clarify, if true, that you have not yet filed an IND for Neurotrophic Keratitis and that OC-01 for this indication is still in the preclinical phase. Certain Relationships and Related Party Transactions Consulting Agreement, page 144 4. We note your revised disclosure on page 144 in response to comment 5. Please provide the required disclosure pursuant to Item 404 of Regulation S-K regarding the amended consulting agreement with FLG Partners, LLC under which Mr. Murray provides general financial advisory services. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate time for us to review any amendment prior to the requested effective date of the registration statement. You may contact Sasha Parikh at 202-551-3627 or Angela Connell at 202-551-3426 if you have questions regarding comments on the financial statements and related matters. Please contact Sonia Bednarowski at 202-551-3666 or Justin Dobbie, Legal Branch Chief, at 202-551- 3469 with any other questions. FirstName LastNameJeffrey Nau Sincerely, Comapany NameOyster Point Pharma, Inc. Division of Corporation Finance October 10, 2019 Page 2 Office of Life Sciences FirstName LastName