October 15, 2018
Rick Pauls
Chief Executive Officer
DiaMedica Therapeutics Inc.
2 Carlson Parkway, Suite 260
Minneapolis, MN 55447
Re: DiaMedica Therapeutics Inc.
Amendment No. 1 to Draft Registration Statement on Form 10
Submitted September 17, 2018
CIK No. 0001401040
Dear Mr. Pauls:
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
statement 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.
Amendment No. 1 to Form 10 submitted September 17, 2018
Item 1. Business
Overview, page 1
1. We note your disclosure on page 24 that you have not yet filed an IND to
initiate a clinical
trial for DM199 in the United States. Please revise the Overview section
to disclose this
fact. In addition, where appropriate, please disclose the locations of
your clinical
trials and the foreign jurisdictions from which you have received
approval to initiate
Rick Pauls
FirstName LastNameRick Pauls
DiaMedica Therapeutics Inc.
Comapany NameDiaMedica Therapeutics Inc.
October 15, 2018
October 15, 2018 Page 2
Page 2
FirstName LastName
clinical trials. To the extent you plan to submit DM199 for marketing
approval in
Australia, please also revise the Regulatory Approval section to
describe the Australian
drug approval process.
Acute Ischemic Stroke, page 3
2. Please explain the basis for your belief that the annual market
opportunity for DM199
could be over $20 billion. Your response should include your material
assumptions
underlying this prediction. In addition, please revise your disclosure
to clarify whether
you are referring to the market opportunity for DM199 for the
treatment of acute ischemic
stroke.
DM199 Clinical Studies, page 11
3. Please revise your disclosure regarding the clinical studies of DM199
you have conducted
to date to provide information, to the extent available, regarding the
dosages studied, the
primary and secondary endpoints, any adverse events and any other
resulting objective
data.
4. We note your disclosure on page 24 that you have been unable to obtain
the complete
study records for the two clinical studies in patients with Type 2
diabetes and that this
may delay your ability to obtain the acceptance of an investigational
new drug
application. Please revise your disclosure to provide additional
information about these
studies, including to which indication these studies relate, what
phase of development
these clinical studies were intended to be, what the primary and
secondary endpoints were
and whether the results are needed to proceed in the development of
the drug.
5. Regarding the trial in which secondary efficacy endpoints were not
met, please revise to
clarify the basis for your belief that this was the result of serious
execution errors by the
contract research organization conducting the trial.
Intellectual Property, page 17
6. We note your disclosure on page 18 that you exclusively license
patents from your
manufacturing partner for the production of DM199 or any human KLK1
protein. Please
disclose the material terms of this license agreement and file it as
an exhibit to the
registration statement, or tell us why you do not believe this is
required. See Item
601(b)(10) of Regulation S-K.
Item 2. Financial Information
Commitments and Contingencies, page 50
7. We note that you are party to a research, development and license
agreement under which
you are required to make milestone and royalty payments. Please expand
your disclosure
to describe the material terms of this agreement, including the
counter-party, the rights
and obligations of each party, the royalty term and term and
termination provisions. In
Rick Pauls
DiaMedica Therapeutics Inc.
October 15, 2018
Page 3
addition, please file the agreement as an exhibit to the registration
statement, or tell us
why you do not believe this is required. See Item 601(b)(10) of
Regulation S-K.
Item 8. Legal Proceedings, page 63
8. Please disclose the information required under Regulation S-K Item 103
with respect to
the litigation referenced on page 24, or tell us why you do not believe
it is required. We
note your disclosure that failure to obtain the reports from the study
that is the subject of
the litigation could result in delay or prevention of clinical
development or regulatory
approval of your lead candidate, DM199.
You may contact Franklin Wyman at 202-551-3660 or Angela Connell at
202-551-3426
if you have questions regarding comments on the financial statements and
related
matters. Please contact Irene Paik at 202-551-6553 or Mary Beth Breslin at
202-551-3625 with
any other questions.
Sincerely,
FirstName LastNameRick Pauls
Division of
Corporation Finance
Comapany NameDiaMedica Therapeutics Inc.
Office of
Healthcare & Insurance
October 15, 2018 Page 3
cc: Amy E. Culbert, Esq.
FirstName LastName