Blueprint
October
7, 2016
VIA EDGAR
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
100 F
Street, N.E., Mail Stop 4546
Washington,
D.C. 20549
Attention:
Suzanne Hayes, Assistant Director
Office
of Healthcare and Insurance
Re:
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Opexa Therapeutics,
Inc.
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Form 10-K for
Fiscal Year Ended December 31, 2015
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Filed March 15,
2016
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File No.
001-33004
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Ladies
and Gentlemen:
This
letter is being submitted in response to comments provided by the
Staff of the Division of Corporation Finance (the
“Staff”) of the
U.S. Securities and Exchange Commission (the “Commission”) set forth in your
letter dated September 27, 2016 with respect to the
above-referenced Annual Report on Form 10-K filed by Opexa
Therapeutics, Inc. (the “Company”). Please find the
Company’s response to the Staff’s comments below. For
your convenience, the Staff’s comments are shown immediately
preceding the Company’s responses thereto.
Business, page 2
Option and License
Agreement with Merck Serono, page 6
1.
We note your statement that you “would also be responsible
for royalty obligations to certain third parties, such as Baylor
College of Medicine from which we originally licensed related
technology.” Please clarify the identity of any party other
than Baylor College to whom you may have royalty obligations, and
please describe the terms of all such royalty obligations,
including to Baylor College.
Response:
The
Company respectfully submits that there is no party to identify
other than Baylor College of Medicine (“Baylor”) to
whom the Company currently may have royalty obligations. However,
depending upon how the Company finalizes its manufacturing process
for commercialization, the Company anticipates that there may
ultimately be royalties due to one or more other parties, and thus
believes that the current disclosure is appropriate in anticipating
that possibility. If and when any such royalty arrangements are
implemented, the Company will include the identity of any such
additional other party(ies) and will describe any such applicable
royalty arrangements.
2635
Technology Forest Boulevard · The Woodlands, Texas · 77381
Phone:
281-775-0600 · Fax:
281-872-8585
Suzanne
Hayes
U.S.
Securities and Exchange Commission
October
7, 2016
Page
2
With
respect to the Company’s license agreement with Baylor, the
Company respectfully directs the Staff’s attention to Exhibit
10.1 of the Company’s Quarterly Report on Form 10-Q filed by
the Company on August 11, 2016. Such Exhibit 10.1 is a copy of
the license agreement with Baylor. Since the confidential treatment
previously granted for this license agreement has expired, such
Exhibit 10.1 is unredacted. Given that an unredacted copy of the
Baylor license agreement is now publicly available, the Company
respectfully submits that full information regarding its terms has
been disclosed and is thus available to any interested parties.
Acknowledging the Staff’s comment, however, the Company will
also include a summary of the Baylor license arrangement in its
upcoming Quarterly Report on Form 10-Q (anticipated to be filed on
or before the November 14, 2016 filing deadline) and in future
periodic report filings as appropriate.
2.
We note that your License Agreement with Baylor College of Medicine
requires you to make certain payments, including milestone payments
and royalties, in the event that Tcelna receives regulatory
approval and is commercialized. Please provide a description of the
License Agreement with Baylor College of Medicine to
disclose:
●
The term of the agreement;
●
the
aggregate amount of potential future milestone
payments;
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the aggregate amount of potential future royalty payments;
and
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the royalty rate within a range that does not exceed ten percent
(e.g. teens, twenties, etc.).
Response:
As
indicated in response to comment 1, because an unredacted copy of
the Baylor license agreement has been filed with the most recent
Quarterly Report on Form 10-Q, the Company respectfully submits
that full information regarding its terms has been disclosed and is
thus available to any interested parties. Acknowledging the
Staff’s comment, however, the Company will also include a
summary of the Baylor license arrangement in its upcoming Quarterly
Report on Form 10-Q (anticipated to be filed on or before the
November 14, 2016 filing deadline) and in future periodic report
filings as appropriate.
Exhibits
Exhibit 10.8
3.
We note that your License Agreement with Baylor College of Medicine
contains redactions pursuant to a request for confidential
treatment, however, the License Agreement’s confidential
treatment has expired. Please file an un-redacted copy of such
agreement.
Response:
As
indicated in response to comment 1, the Company respectfully
directs the Staff’s attention to Exhibit 10.1 of the
Company’s Quarterly Report on Form 10-Q previously filed by
the Company on August 11, 2016. Such Exhibit 10.1 is a copy of
the license agreement with Baylor. Since the confidential treatment
previously granted for this license agreement has expired, such
Exhibit 10.1 is unredacted.
2635
Technology Forest Boulevard · The Woodlands, Texas · 77381
Phone:
281-775-0600 · Fax:
281-872-8585
Suzanne
Hayes
U.S.
Securities and Exchange Commission
October
7, 2016
Page
3
Exhibit 10.10
4.
We note that you have entered into a License Agreement dated
January 13, 2006 with the Shanghai Institute for Biological
Services, however, no description of such agreement is contained in
your Annual Report. Please delete this agreement from your Exhibit
Index if this agreement is no longer material or revise the
disclosures to describe the License Agreement, including the
material terms.
Response:
The
Company acknowledges the Staff’s comment and will delete such
agreement from the Exhibit List for its next Annual Report on Form
10-K, as the license agreement is indeed no longer
material.
In
providing this response, the Company acknowledges
that:
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the Company is
responsible for the adequacy and accuracy of the disclosure in the
filing;
●
Staff comments or
changes to disclosure in response to Staff comments do not
foreclose the Commission from taking any action with respect to the
filing; and
●
the Company may not
assert Staff comments as a defense in any proceeding initiated by
the Commission or any person under the federal securities laws of
the United States.
Please
let us know if we can provide any further information.
Additionally, please do not hesitate to call the Company’s
counsel, Patty DeGaetano at (858) 509-4033 or Mike Hird at (858)
509-4024, of Pillsbury Winthrop Shaw Pittman LLP.
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Sincerely,
OPEXA
THERAPEUTICS, INC.
/s/
Neil K. Warma
Neil K.
Warma
President and Chief
Executive Officer
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cc:
Pillsbury Winthrop Shaw Pittman LLP
2635
Technology Forest Boulevard · The Woodlands, Texas
· 77381
Phone:
281-775-0600 · Fax:
281-872-8585
|