SEC Comment Letter for Outlook Therapeutics, Inc. (OTLK) (CIK 0001649989) (OTLK) — Feb 26, 2016
Outlook Therapeutics, Inc. (OTLK) (CIK 0001649989)
Date: Feb. 26, 2016 · CIK: 0001649989 · Accession: 0000000000-16-066462
AI Filing Summary & Sentiment
Letter
Mail Stop 4720 February 26, 2016 Pankaj Mohan, Ph.D. President and Chief Executive Officer Oncobiologics, Inc. 7 Clarke Drive Cranbury, New Jersey 08512
Re: Oncobiologics, Inc. Amendment No. 1 to Registration Statement on Form S -1 Filed February 12, 2016 File No. 333 -209011
Dear Dr. Mohan:
We have reviewed your amended registration statement and have the following comment . In our comment , 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 b elieve our comment applies to your facts and circumstances or do not b elieve 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 this comment , we may have additional comments.
Intellectual Property, page 93
1. You state that you own two PCT patent applications directed to certain formulations and methods of purification as well as six provisional patent applications directed to a number of methods and formulations. Similarly, on page 36, you state tha t you have filed two patent applications directed to your formulations and processes for your product candidates and others directed to aspects of your downstream manufacturing processes for various biosimilars, including ONS -3010. On page 93, you provide an expected expiration date of 2034 for one PCT application and an expected expiration date of 2036 for a U.S. provisional patent application relating to methods of purification. Please revise your disclosure to clarify the expected expiration dates of p atents potentially issuing from the eight patent applications you describe.
Pankaj Mohan, Ph.D. Oncobiologics, Inc. February 26, 2016 Page 2
You may contact James Peklenk at (202) 551 -3661 or Sharon Blume at (202) 551 -4407 if you have questions regarding comments on the financial statements and related matters. Pl ease contact Tara Keating Brooks at (202) 551 -8336, Amy Reischauer at (202) 551 -3793, or me at (202) 551 -3675 with any other questions.
Sincerely,
/s/ Amy Reischauer for
Show Raw Text
Mail Stop 4720
February 26, 2016
Pankaj Mohan, Ph.D.
President and Chief Executive Officer
Oncobiologics, Inc.
7 Clarke Drive
Cranbury, New Jersey 08512
Re: Oncobiologics, Inc.
Amendment No. 1 to Registration Statement on Form S -1
Filed February 12, 2016
File No. 333 -209011
Dear Dr. Mohan:
We have reviewed your amended registration statement and have the following comment .
In our comment , 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 b elieve our comment applies to your facts and
circumstances or do not b elieve 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 this comment , we may have additional comments.
Intellectual Property, page 93
1. You state that you own two PCT patent applications directed to certain formulations and
methods of purification as well as six provisional patent applications directed to a number
of methods and formulations. Similarly, on page 36, you state tha t you have filed two
patent applications directed to your formulations and processes for your product
candidates and others directed to aspects of your downstream manufacturing processes
for various biosimilars, including ONS -3010. On page 93, you provide an expected
expiration date of 2034 for one PCT application and an expected expiration date of 2036
for a U.S. provisional patent application relating to methods of purification. Please revise
your disclosure to clarify the expected expiration dates of p atents potentially issuing from
the eight patent applications you describe.
Pankaj Mohan, Ph.D.
Oncobiologics, Inc.
February 26, 2016
Page 2
You may contact James Peklenk at (202) 551 -3661 or Sharon Blume at (202) 551 -4407 if
you have questions regarding comments on the financial statements and related matters. Pl ease
contact Tara Keating Brooks at (202) 551 -8336, Amy Reischauer at (202) 551 -3793, or me at
(202) 551 -3675 with any other questions.
Sincerely,
/s/ Amy Reischauer for
Suzanne Hayes
Assistant Director
Office of Healthcare and Insurance
cc: Yvan -Claude Pierre, Cooley LLP