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February 8, 2019
Joseph Oliveto
Chief Executive Officer
Milestone Pharmaceuticals Inc.
6000 Fairview Road, Suite 1200
Charlotte, NC 28210-2252
Re: Milestone Pharmaceuticals Inc.
Draft Registration Statement on Form S-1
Filed December 21, 2018
CIK 0001408443
Dear Mr. Oliveto:
We have reviewed your 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.
DRS Form S-1
Prospectus Summary
Overview, page 1
1. We note your reference to statistical significance in the second
paragraph of this section.
Please expand your discussion to explain the term and discuss how
statistical significance
relates to the FDA's evidentiary standards of efficacy.
2. We note your disclosure that you expect top-line data for the Phase 3
trial of etripamil in
the first half of 2020. Please also clarify that your Phase 3 clinical
program includes two
safety trials and the expected timing for those trials.
Joseph Oliveto
FirstNamePharmaceuticals Inc.
Milestone LastNameJoseph Oliveto
Comapany NameMilestone Pharmaceuticals Inc.
February 8, 2019
February 8, 2019 Page 2
Page 2
FirstName LastName
Our Pipeline, page 1
3. We note the inclusion in your pipeline table of etripamil for atrial
fibrillation and angina
and that you do not intend to use any of the net proceeds of this
offering to conduct
clinical trials of etripamil for these indications. Please revise your
table to remove these
programs, or alternatively, explain how you are currently pursuing
etripamil in atrial
fibrillation and angina.
4. It appears from the pipeline chart that you have completed separate
Phase 1 clinical trials
of etripamil for atrial fibrillation and angina. Please separately
describe the trials for these
indications in the Business section.
Implications of Being an Emerging Growth Company, page 6
5. Please supplementally provide us with copies of all written
communications, as defined
in Rule 405 under the Securities Act, that you, or anyone authorized
to do so on your
behalf, present to potential investors in reliance on Section 5(d) of
the Securities Act,
whether or not they retain copies of the communications.
Use of Proceeds, page 53
6. Please disclose whether the amount of funds allocated for the Phase 3
clinical trial of
PSVT will be sufficient to complete the Phase 3 trial. If any material
amounts of other
funds are necessary, please disclose the amount of funds needed to
complete Phase 3.
Refer to Instruction 3 to Item 504 of Regulation S-K.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Overview, page 63
7. Please reconcile your disclosure here that you expect to initiate a
Phase 2 clinical trial of
etripamil in atrial fibrillation in the first half of 2020 with your
disclosure on pages 1 and
71 that you are planning the Phase 2 trial for atrial fibrillation for
the second half of 2019.
Components of Results of Operations
Research and Development Expenses, page 64
8. We note your product candidate, etripamil, is being developed for
multiple development
projects, including paroxysmal supraventricular tachycardia, atrial
fibrillation, and
angina. Please revise your disclosure to separately break out research
and development
costs by each project for each period presented and to date. Your
disclosure should also
provide explanation of period to period fluctuations. If you do not
track costs by these
measures, please disclose that fact. Provide other quantitative or
qualitative disclosure
that indicates the amount of the company's resources being used on
each project.
Joseph Oliveto
Milestone Pharmaceuticals Inc.
February 8, 2019
Page 3
Critical Accounting Policies and Estimates
Share-Based Compensation, page 69
9. Once you have an estimated offering price or range, please explain to us
how you
determined the fair value of the common stock underlying your equity
issuances and the
reasons for any differences between the recent valuations of your common
stock leading
up to the initial public offering and the estimated offering price. This
information will help
facilitate our review of your accounting for equity issuances including
stock compensation
and beneficial conversion features.
Management
Limitation on Liability and Indemnification Matters, page 102
10. You disclose that you entered into indemnity agreements with your
directors and officers.
Please file a copy of the form of indemnity agreement as an exhibit to
this registration
statement as required under Item 601(b)(10) of Regulation S-K.
Principal Shareholders, page 121
11. Please revise your disclosure to identify the natural person or persons,
if any, who have
voting and investment control of the shares held by BDC Capital, Inc. and
affiliates.
General
12. Please provide us proofs of all graphics, visual, or photographic
information you will
provide in the printed prospectus prior to its use, for example in a
preliminary prospectus.
Please note that we may have comments regarding this material.
You may contact William Demarest at (202) 551-3432 or Yolanda Trotter
at (202) 551-
3472 if you have questions regarding comments on the financial statements and
related
matters. Please contact Elizabeth Walsh at (202) 551-3696 or Chris Edwards at
(202) 551-
6761 with any other questions.
Sincerely,
FirstName LastNameJoseph Oliveto
Division of
Corporation Finance
Comapany NameMilestone Pharmaceuticals Inc.
Office of
Healthcare & Insurance
February 8, 2019 Page 3
cc: Jaime L. Chase
FirstName LastName