SEC Comment Letter for Outlook Therapeutics, Inc. (OTLK) (CIK 0001649989) (OTLK) — Dec 30, 2015
Outlook Therapeutics, Inc. (OTLK) (CIK 0001649989)
Date: Dec. 30, 2015 · CIK: 0001649989 · Accession: 0000000000-15-059893
AI Filing Summary & Sentiment
Letter
Mail Stop 4720 December 30, 2015 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 Draft Registration Statement on Form S -1 Submitted December 18, 2015 CIK No. 0001649989
Dear Dr. Mohan :
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 stateme nt 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.
Our Pipeline , page 1
1. We refer to your table on page 1 and our prior comment 3. Please revise your disclosure in this section regarding ONS -4010 to identify the approved therapeutic use for the referenced product. In addition, please state whether you intend to seek the same indication and how your product is intended to be delivered. If you have not determined an indication or method of delivery fo r ONS -4010, please so state.
Risks Associated with Our Business , page 4
2. We note your response to our prior comment 4. Please revise your disclosure in your revised bullet points to address the risk associated with your license agreement(s) (e.g.
Pankaj Mohan, Ph.D Oncobiologics, Inc. December 30, 2015 Page 2
Selex is) to include the patents licensed pursuant to the agreement(s) and the risk associated with obtaining third party commercialization agreements.
Collaboration and License Agreements , page 85
3. Please revise your disclosures relating to Swiss Franc (CH F) payments to provide for the U.S. dollar equivalent.
Intellectual Property, page 88
4. Please revise your disclosure to explain the meaning and significance of “PCT.” In that regard, describe briefly the process of obtaining such patent, the benefits or potential protections of the pending PCT, whether patents have been granted pursuant to a PCT for biosimiliars , and in what jurisdictions you are currently seeking patent protection.
Agreements with our Named Executive Officers, page 104
5. We note that your employment agreement with Dr. Mohan terminates upon the company’s initial public o ffering of stock. We also note your dependence on Dr. Mohan as disclosed on page 5. Please revise your disclosure to discuss whether you intend to enter into or extend Dr. Mohan’s current employment agreement. Please make any corresponding changes to the corresponding risk factor on page 41.
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. Please 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/ Suzanne Hayes
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Mail Stop 4720
December 30, 2015
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 Draft Registration Statement on Form S -1
Submitted December 18, 2015
CIK No. 0001649989
Dear Dr. Mohan :
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 stateme nt 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.
Our Pipeline , page 1
1. We refer to your table on page 1 and our prior comment 3. Please revise your disclosure
in this section regarding ONS -4010 to identify the approved therapeutic use for the
referenced product. In addition, please state whether you intend to seek the same
indication and how your product is intended to be delivered. If you have not determined
an indication or method of delivery fo r ONS -4010, please so state.
Risks Associated with Our Business , page 4
2. We note your response to our prior comment 4. Please revise your disclosure in your
revised bullet points to address the risk associated with your license agreement(s) (e.g.
Pankaj Mohan, Ph.D
Oncobiologics, Inc.
December 30, 2015
Page 2
Selex is) to include the patents licensed pursuant to the agreement(s) and the risk
associated with obtaining third party commercialization agreements.
Collaboration and License Agreements , page 85
3. Please revise your disclosures relating to Swiss Franc (CH F) payments to provide for the
U.S. dollar equivalent.
Intellectual Property, page 88
4. Please revise your disclosure to explain the meaning and significance of “PCT.” In that
regard, describe briefly the process of obtaining such patent, the benefits or potential
protections of the pending PCT, whether patents have been granted pursuant to a PCT for
biosimiliars , and in what jurisdictions you are currently seeking patent protection.
Agreements with our Named Executive Officers, page 104
5. We note that your employment agreement with Dr. Mohan terminates upon the
company’s initial public o ffering of stock. We also note your dependence on Dr. Mohan
as disclosed on page 5. Please revise your disclosure to discuss whether you intend to
enter into or extend Dr. Mohan’s current employment agreement. Please make any
corresponding changes to the corresponding risk factor on page 41.
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. Please
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/ Suzanne Hayes
Suzanne Hayes
Assistant Director
Office of Healthcare and Insurance
cc: Via E -mail
Yvan -Claude Pierre
Cooley LLP