United States securities and exchange commission logo
December 13, 2020
Eric Richman
Chief Executive Officer
Gain Therapeutics, Inc.
4800 Hampden Lane, Suite 200
Bethesda, MD 20814
Re: Gain Therapeutics,
Inc.
Draft Registration
Statement on Form S-1
Submitted November
16, 2020
CIK No.: 0001819411
Dear Mr. Richman:
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.
Draft Registration Statement on Form S-1, Submitted November 16, 2020
About this Prospectus
Market, Industry, and Other Data, page ii
1. We note that you state
you have not independently verified any of the data from third-
party sources nor have
you ascertained the underlying economic assumptions relied upon
therein. It is not
appropriate to directly or indirectly disclaim liability for statements in
your registration
statement. Please revise or specifically state that you take liability for
these statements.
Summary, page 1
2. You state in the first
paragraph that you use your SEE-Tx platform to "restore protein
Eric Richman
FirstName LastName Eric Richman
Gain Therapeutics, Inc.
Comapany13,
December NameGain
2020 Therapeutics, Inc.
December
Page 2 13, 2020 Page 2
FirstName LastName
folding and function and treat the underlying disease." Please balance
your statement
by clarifying that your platform is novel and untested, and that all
of your product
candidates remain in discovery or have not yet reached IND-enabling
studies.
3. On page 1 you state: We have already identified and patented
several novel Structurally
Targeted Allosteric Regulators ( STARs ). However, we note your
disclosure on page
74, which states that your only issued patent is in-licensed and
relates to SEE-Tx, and
your disclosure on page 7, where you state you hold three provisional
patents. Please
revise your discussion in this "Overview" section to highlight that
your SEE-Tx platform
technology is in-licensed, that you do not own any issued patents, and
that neither the
issued patent nor the pending patent applications cover the United
States, and revise your
bullet on page 7 accordingly. In addition, in your Business section,
please expand your
Intellectual Property discussion to also include a discussion of the
European regulations.
4. Please revise page 3 to describe the random screening process and its
reliance on
supercomputing technology, and how it differs from your
validated-target approach.
5. Please explain what is involved in "lead-OP" and why you believe this
is a separate
and distinct development phase, as opposed to part of your discovery
or IND-enabling
studies. Please also explain why you believe it is appropriate to
present "in vitro" and "in
vivo" as separate phases in the pipeline table.
6. Please tell us why you feel the undisclosed target for demyelinating
disease should be
included in your pipeline table on page 4 and elsewhere given its
early stage and given
that it is undisclosed and not further described in this prospectus.
Please also remove the
references to the Michael J. Fox Foundation and the Silverstein
Foundation from the
pipeline table as it does not appear that they are conducting the
research with you but
rather, have provided grants to you.
7. Please revise the references on pages 6-7 and elsewhere to rapidly
advancing your lead
product candidates into clinical development, and expedited regulatory
approval strategies
to avoid any implication that you have the ability to accelerate FDA
approvals and
commercialization of your products. Please briefly explain the FDA
programs you may
expect to rely on to seek accelerated approval.
8. We note your references in the Summary to various collaboration
agreements and
partnerships, but that you have not filed any of these agreements as a
material agreement,
and that you have limited disclosure regarding the terms of these
arrangements in your
Business section. To the extent these are not material agreements,
please explain why it is
appropriate to reference these arrangements in the Summary. To the
extent they are
material, please revise your disclosures as appropriate to disclose
all material terms and
file such agreements. In addition, please revise to disclose whether
you have rights to all
data produced in such partnerships or collaborations, or describe any
material limitations.
Eric Richman
FirstName LastName Eric Richman
Gain Therapeutics, Inc.
Comapany13,
December NameGain
2020 Therapeutics, Inc.
December
Page 3 13, 2020 Page 3
FirstName LastName
Implications of Being an Emerging Growth Company and Smaller Reporting Company,
page 8
9. 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.
Summary Financial Data, page 12
10. Given the automatic conversion of all your outstanding preferred
shares into common
stock which will occur simultaneously with the closing of this
offering, please provide pro
forma earnings per share data here and on page 48 to reflect the
impact of such
conversion.
Risk Factors, page 13
11. Please include risk factor disclosure detailing the risks involved
with certain of the
provisions of your amended and restated certificate of incorporation
and amended and
restated bylaws you describe on pages 93-94, including as an example
only, anti-takeover
effects.
12. Please revise the heading for your penultimate risk factor on page 14
to disclose that you
may not be able to raise additional funds and the significance of such
an event.
Use of Proceeds, page 43
13. Please revise to clarify the specific product candidates covered by
the first bullet, and also
to disclose an estimate of how far in your development of your product
candidates the
proceeds from this offering will allow you to reach with respect to
each product candidate.
Also, if material amounts of other funds are necessary to accomplish
the specified
purposes, provide an estimate of the amounts of such other funds and
the sources thereof.
Contractual Obligations and Commitments, page 55
14. Please revise your contractual obligations table to present the
information in U.S. dollars.
Our Business, page 61
15. Please revise to discuss the effect of governmental regulations on
your business and the
need for governmental approval of your product candidates. Please also
state the number
of people you employ. Refer to Item 101(h)(4)(viii), (ix), (xi), and
and (xii) of Regulation
S-K.
Development Pipeline
GLB Enzyme-Related Disorders: GM1 Gangliosidosis and Morquio B, page 64
16. We refer to your statements on page 66 in the graphic that GT-GM1
is effective in
Eric Richman
FirstName LastName Eric Richman
Gain Therapeutics, Inc.
Comapany13,
December NameGain
2020 Therapeutics, Inc.
December
Page 4 13, 2020 Page 4
FirstName LastName
reducing substrate accumulation, and that in the toxicity study in
mice, all the molecules
showed a "favorable" toxicity profile. Please revise this and any
similar statements in your
prospectus that state or imply that your development product
candidates are safe or
effective as these determinations are solely within the authority of
the FDA and
comparable regulatory bodies, and they continue to be evaluated
throughout all trial
phases. We do not object to the presentation of objective data
resulting from your trials
without conclusions related to safety or efficacy.
17. With respect to the description of your studies of your GLB STAR lead
compounds on
page 66, please revise to provide the number of mice and duration for
your toxicity studies
and the number of mice in your pharmacokinetic studies. Also explain
your statement on
page 66 that GT-00413 was well-tolerated "without showing clinical
signs." Please also
provide a narrative explanation for the bone-plasma ratio similar to
your discussion of the
brain/plasma ratio.
18. With respect to the description of your studies of your GBA1 STAR lead
compounds on
page 70, please revise to provide the number of mice and duration of
your toxicity studies
and explain the basis for your statements that there was high brain
exposure and
positive brain-to-plasma ratio level.
IDUA Enzyme-Related Disorders: Mucopolysaccharidosis Type 1, page 70
19. With respect to the description of your studies of your IDUA compounds
on page 71,
please revise to provide the number of mice and duration for all
studies and, with respect
to your pharmacokinetic studies, the meaning of positive
bioavailability, including
whether this relates to bioavailability in the brain specifically.
With respect to your
pharmacology studies, please also explain what laronidase isand
clarify whether you
performed any pharmacology studies with the STARs alone or just
combination therapy.
License Agreement with Minoryx Therapeutics, S.I., page 73
20. Please revise the description of the License Agreement with Minoryx
Therapeutics, S.I. on
page 73 to discuss the nature and scope of intellectual property
transferred, including the
specific type of patent protection provided to any of your development
product candidates.
Intellectual Property, page 74
21. Please revise to clarify which of your in-licensed issued patents and
patent applications
discussed on page 74 are under the Minoryx agreement, and also
disclose whether there
are any material patent rights under the agreement that are
sublicensed by Minoryx from
third parties such as the University of Barcelona.
Description of Capital Stock, page 91
22. On page 95 you state: The Court of Chancery of the State of
Delaware is not the sole and
exclusive forum for actions brought under the federal securities laws
and on page 40 you
Eric Richman
Gain Therapeutics, Inc.
December 13, 2020
Page 5
state: the exclusive forum provisions will not apply to suits
brought to enforce any
liability or duty created by the Securities Act or the Exchange Act, or
to any claim for
which the federal courts have exclusive jurisdiction. Please revise to
clearly state whether
your amended and restated certificate of incorporation provides an
exclusive forum
requirement for claims under the federal securities laws.
Exhibits
23. Please file your directorship agreements discussed on page 89 as well as
your employment
agreements with Manolo Bellotto and Eric I. Richman pursuant to Item
601(b)(10) of
Regulation S-K.
24. Please tell us how you determined none of your leases were required to be
filed under
Item 601(b)(10) of Regulation S-K.
25. We note your statement on page 87 referring investors to various
agreements relating to
your merger and related transactions that are not included as exhibits to
this registration
statement. Please reconcile your disclosures.
You may contact Ibolya Ignat at 202-551-3636 or Jeanne Baker at
202-551-3691 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Margaret Schwartz at 202-551-7153 or Dorrie Yale at 202-551-8776 with
any other
questions.
Sincerely,
FirstName LastName Eric Richman
Division of
Corporation Finance
Comapany NameGain Therapeutics, Inc.
Office of Life
Sciences
December 13, 2020 Page 5
cc: Andrea Nicolas, Esq.
FirstName LastName