October
26, 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
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Attention:
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Suzanne Hayes,
Assistant Director
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Office of
Healthcare and Insurance
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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 October 18, 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 response to Comments 1 and 2 of our letter dated
September 27, 2016. Please provide us with the description of the
License Agreement with Baylor College of Medicine which you intend
to include in your next Quarterly Report on Form 10-Q.
Response:
The
Company intends to include the following description of the License
Agreement with Baylor College of Medicine in its Quarterly Report
on Form 10-Q and in future periodic reports as
appropriate:
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
26, 2016
Page
2
License Agreement
with Baylor College of Medicine
In 2001, Opexa
entered into an agreement with Baylor College of Medicine
(“Baylor”) for the exclusive worldwide license to a
patient-specific, autologous T-cell immunotherapy for the treatment
of multiple sclerosis (“MS”), which is the initial
T-cell technology on which Tcelna is based, including rights to
certain patents held by Baylor. In consideration for the right and
license to commercially exploit such technology, Opexa agreed to
pay the following (per scenario 1 of the license agreement): (i) a
2% royalty on net sales of licensed patented products sold by Opexa
or its affiliates where annual gross sales of such products is less
than or equal to $500 million; (ii) a 1% royalty on net sales of
licensed patented products sold by Opexa or its affiliates where
annual gross sales of such products exceed $500 million; (iii) a 1%
royalty on net sales of licensed patent pending products sold by
Opexa or its affiliates; and (iv) a 1% royalty on net sales of
licensed patented products or licensed patent pending products sold
by any sublicensees of Opexa (which would include Merck Serono if
it exercises its option to acquire the Tcelna program pursuant to
the Option Agreement (described above), and ultimately receives
regulatory approval and commercializes Tcelna). Unless earlier
terminated, the Baylor license agreement expires in 2025 upon
expiration of the last of the patent rights.
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.
Sincerely,
OPEXA THERAPEUTICS,
INC.
/s/ Neil K. Warma
Neil K. Warma
President and Chief Executive
Officer
cc: Pillsbury Winthrop Shaw Pittman
LLP
2635
Technology Forest Boulevard ▪ The Woodlands, Texas ▪
77381
Phone: 281-775-0600
▪ Fax: 281-872-8585
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