July 12, 2019
Douglas J. Swirsky
President, Chief Executive Officer and Director
REXAHN PHARMACEUTICALS, INC.
15245 Shady Grove Rd
Suite 455
Rockville, Maryland 20850
Re: REXAHN PHARMACEUTICALS, INC.
Form 10-K for Fiscal Year Ended December 31, 2018
Filed March 7, 2019
Form 10-Q for Quarterly Period Ended March 31, 2019
Filed May 10, 2019
File No. 001-34079
Dear Mr. Swirsky:
We have reviewed your filings 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 these comments within ten business days by providing
the requested
information or advise us as soon as possible when you will respond. If you do
not believe our
comments apply to your facts and circumstances, please tell us why in your
response.
After reviewing your response to these comments, we may have additional
comments.
Form 10-K for the Fiscal Year Ended December 31, 2018
Item 1 Description of Business
Our Pipeline Product Candidates, page 4
1. We note your disclosures on pages 4-7 stating that your product
candidates, including RX-
3117, RX-5902, and RX-0201, "appeared to be safe." Further, we note your
disclosure
that RX-3117 "appeared to be safe... with preliminary signs of efficacy."
Safety and
efficacy determinations are solely within the authority of the FDA.
Please remove
statements or inferences that your product candidates are or appeared to
be safe and
effective. You may provide the objective results of the clinical trials
with the stated
endpoints and indicate whether the candidate was well tolerated.
Douglas J. Swirsky
FirstName PHARMACEUTICALS, INC.
REXAHN LastNameDouglas J. Swirsky
Comapany NameREXAHN PHARMACEUTICALS, INC.
July 12, 2019
July 12, 2019 Page 2
Page 2
FirstName LastName
Notes to Financial Statements
14. Collaboration Agreements
Zhejiang Haichang Biotechnology Co., Ltd., page F-26
2. On February 8, 2018, you entered into a research and development
collaboration
agreement with Zhejiang Haichang Biotechnology Co., Ltd ("Haichang")
under which
Haichang will develop RX-0301 using Haichang's proprietary QTsome
technology. You
further indicate that Haichang will conduct certain preclinical and
clinical activities
through completion of Phase 2a proof of concept clinical trial in
China. At that time,
Haichang may obtain an exclusive license to further develop and
commercialize RX-0301
in China and will pay customary license fees, milestones and royalty
payments to you.
Please address the following:
Tell us whether you gave any upfront consideration to Haichang for
the preclinical and
clinical activities it is to perform through completion of Phase
2a proof of concept
clinical trial in China;
Tell us whether any licenses were exchanged upfront;
Explain to us how you are accounting for this agreement, including
the specific
accounting literature you relied upon when making such
determination; and
Quantify and describe for us any related amounts recorded in your
financial statements
during the year ended December 31, 2018 and the quarter ended
March 31, 2019.
Form 10-Q for the Fiscal Quarter Ended March 31, 2019
Notes to Condensed Financial Statements
7 Collaboration Agreement, page 10
3. On February 25, 2019, you entered into a collaboration agreement with
BioSense Global
LLC ("BioSense") to advance the development and commercialization of
RX-3117 for
pancreatic and other cancers in certain territories. Please address
the following:
Clarify for us whether you believe the granting of the exclusive
license to develop and
promise to supply RX-3117 are distinct performance obligations. If
so, explain to us
in further detail how you made this determination;
Quantify for us the portion of the $3,000,000 transaction price
that you will allocate to
each performance obligation and describe when and how you expect
to recognize the
related revenue for each (ex: at a point in time, over time); and
Douglas J. Swirsky
REXAHN PHARMACEUTICALS, INC.
July 12, 2019
Page 3
Describe and disaggregate for us further the $226,000,000
milestones the company is
eligible to receive by development, regulatory, commercial
categories and further
disaggregate, if applicable, by indication and geographic area.
Considering the
significant amount of potential milestones, tell us your
consideration of disclosing an
accounting policy that describes the factors you consider when
determining whether
milestones should be constrained or included in the transaction
price.
4. Please file the collaboration agreement with BioSense as an Exhibit or
provide us with an
analysis supporting your determination that you are not substantially
dependent on the
agreement.
We remind you that the company and its management are responsible for
the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action
or absence of
action by the staff.
You may contact Andi Carpenter at 202-551-3645 or Sharon Blume at
202-551-3474
with any questions.
FirstName LastNameDouglas J. Swirsky Sincerely,
Comapany NameREXAHN PHARMACEUTICALS, INC.
Division of Corporation Finance
July 12, 2019 Page 3 Office of Healthcare & Insurance
FirstName LastName