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www.wsgr.com |
October 15, 2019
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
Office of Healthcare & Insurance
100 F Street, N.E.
Washington, D.C. 20549-3720
| Attention: | Sonia Bednarowski |
Justin Dobbie |
Sasha Parikh |
Angela Connell |
| Re: | Oyster Point Pharma, Inc. |
Registration Statement on FormS-1 |
Filed on October 4, 2019 |
FileNo. 333-234104 |
CIK No. 0001720725 |
Ladies and Gentlemen:
On behalf of our client, Oyster Point Pharma, Inc. (the “Company”), we submit this letter in response to comments from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) contained in its letter dated October 10, 2019 relating to the above referenced Registration Statement on FormS-1 (the “Registration Statement”). We are concurrently submitting via EDGAR this letter and a revised draft of the Registration Statement (the “Submission No. 4”). For the Staff’s reference, we have included both a clean copy of Submission No. 4 and a copy marked to show all changes from the version submitted on October 4, 2019.
In this letter, we have recited the comments from the Staff in italicized, bold type and have followed each comment with the Company’s response. Except for the page references contained in the comments of the Staff, or as otherwise specifically indicated, page references herein correspond to the page of Submission No. 4.
AUSTIN BEIJING BOSTON BRUSSELS HONG KONG LONDON LOS ANGELES NEW YORK PALO ALTO
SANDIEGO SANFRANCISCO SEATTLE SHANGHAI WASHINGTON,DC WILMINGTON,DE
Securities and Exchange Commission
October 15, 2019
Page 2
Registration Statement on FormS-1 (filed October 4, 2019)
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 nohead-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. |
The Company respectfully advises the Staff that in response to the Staff’s comments, the Company has revised the disclosure on pages 1, 69, 82 and 84 of Submission No. 4.
| 2. | We note your response to comment 4 that you do not expect to continue to pursue FDA approval ofOC-02 for the treatment of dry eye disease. If true, please revise throughout to clarify that you do not intend to pursue FDA approval forOC-02 for the treatment of dry eye disease. |
The Company respectfully advises the Staff that in response to the Staff’s comments, the Company has revised the disclosure on pages 3, 4, 83, 84, 85, 98 of Submission No. 4.
Business
Our Product Candidates, page 89
| 3. | Please revise your pipeline chart to indicate the therapeutic area forOC-02. In addition, please tell us what you mean by “oral indication” in the chart as your disclosure on page 99 states thatOC-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 forOC-02 in a different indication, please revise the chart to indicate thatOC-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 thatOC-01 for this indication is still in the preclinical phase. |
The Company respectfully advises the Staff that it has revised the pipeline chart on page 89 of Submission No. 4 to (i) removeOC-02, (ii) indicate thatOC-01 is still in the preclinical phase for the treatment of neurotrophic keratitis and (iii) state that the next step for the treatment of neurotrophic keratitis withOC-01 will be to file an IND for a Phase 2 clinical trial.
Securities and Exchange Commission
October 15, 2019
Page 3
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 RegulationS-K regarding the amended consulting agreement with FLG Partners, LLC under which Mr. Murray provides general financial advisory services. |
The Company respectfully advises the Staff that in response to the Staff’s comments, the Company has revised the disclosure on page 144 of Submission No. 4.
* * * *
Securities and Exchange Commission
October 15, 2019
Page 4
Please direct any questions with respect to this confidential submission to me at (212)497-7736 or mbaier@wsgr.com.
Sincerely,
WILSON SONSINI GOODRICH & ROSATI
Professional Corporation
/s/ Megan J. Baier
Megan J. Baier
| cc: | Jeffrey Nau, Ph.D., M.M.S., Oyster Point Pharma, Inc. |
Daniel Lochner, Oyster Point Pharma, Inc. |
Tony Jeffries, Wilson Sonsini Goodrich & Rosati, P.C. |
Jennifer Fang, Wilson Sonsini Goodrich & Rosati, P.C. |
Brian J. Cuneo, Latham & Watkins LLP |
Nathan Ajiashvili, Latham & Watkins LLP |