United States securities and exchange commission logo
March 17, 2021
Jerry Katzman
Chief Executive Officer
RetinalGenix Technologies Inc.
1450 North McDowell Boulevard, Suite 150
Petaluma, CA 94954
Re: RetinalGenix
Technologies Inc.
Draft Registration
Statement on Form S-1
Submitted February
16, 2021
CIK No. 0001836295
Dear Mr. Katzman:
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
Prospectus Summary
Business Overview, page 5
1. We note your disclosure
here that you have "developed" two devices aimed at preventing
loss of vision, but you
later disclose on page 37 that you will need $5,000,000 to complete
product design and
testing for both devices. We also note your disclosure on page 36 that
you believe
RetinalGenix will require 510(k) clearance which you have not applied for
yet and that you
believe RetinalCam will be considered an exempt device and do not
anticipate needing
510(k) clearance. Please revise the Prospectus Summary and the
Business section to
provide the current status of development of your product candidates,
any regulatory
applications submitted and the status, or that you intend to submit and the
Jerry Katzman
FirstName LastNameJerry
RetinalGenix TechnologiesKatzman
Inc.
Comapany
March NameRetinalGenix Technologies Inc.
17, 2021
March2 17, 2021 Page 2
Page
FirstName LastName
timeline for doing so, and your anticipated developmental timelines.
Please disclose the
additional funding that you will need to develop your products and how
you intend to
obtain such additional funding. Please also revise these sections to
state that you currently
do not have any products approved for sale and have not generated any
revenue from
product sales.
2. We note that you refer to your products as "patented" throughout the
filing, but you later
state that you anticipate having patented technology. Please advise
and revise where
appropriate. Please also remove the statement on page 37 that you
anticipate having
patented technology that will allow you to produce an office device
superior to those on
the market at an attractive price point as this statement is
speculative.
Our Certificate of Incorporation provides that the Court of Chancery of the
State of Delaware
will be the sole and exclusive forum, page 23
3. Please revise this risk factor to disclose that there is also a risk
that your exclusive forum
provision may result in increased costs for investors to bring a
claim.
Selling Stockholders, page 25
4. It does not appear that the shares listed in the beneficial ownership
of common stock prior
to the offering column add up to 46,536,713 shares. Please revise or
advise.
Description of Business
Competition, page 35
5. Please revise to specify how you face competition from Optomed plc.
and Optos plc. such
as what their competing products are and whether they are in
development or already
being sold. Refer to Item 101(h)(4)(iv) of Regulation S-K.
Intellectual Property Portfolio, page 35
6. Please revise to disclose whether you own or license any patents, the
specific product
candidates or technologies which are covered by the patents, the type
of patent protection
granted (i.e., composition of matter, use, or process), the expiration
dates, and the
jurisdictions. Please provide similar disclosure for any pending
patent applications.
Managements Discussion and Analysis of Financial Condition and Results of
Operations, page
37
7. Please disclose the costs incurred during each period presented for
each of your key
research and development projects. If you do not track your research
and development
costs by project, please disclose that fact and explain why you do not
maintain and
evaluate research and development costs by project. Provide other
quantitative or
qualitative disclosure that provides more transparency as to the type
of research and
development expenses incurred (i.e. by nature or type of expense)
which should reconcile
to total research and development expense on the Statements of
Operations.
Jerry Katzman
FirstName LastNameJerry
RetinalGenix TechnologiesKatzman
Inc.
Comapany
March NameRetinalGenix Technologies Inc.
17, 2021
March3 17, 2021 Page 3
Page
FirstName LastName
In addition, please provide similar quantitative or qualitative
disclosure related to your
Administrative Expenses.
Certain Relationships and Related Party Transactions and Director Independence,
page 44
8. Please revise to include any disclosure required by Item 404(d) of
Regulation S-K for the
period since the beginning of your last completed fiscal year. Refer
to Item 404(d) and
Instruction 2 to Item 404(d) of Regulation S-K.
Director Independence, page 44
9. We note that your board of directors has determined that Mr. Gould is
an independent
director using the Nasdaq definition of independence. Please explain
how you came to
this conclusion since Mr. Gould is the Chief Science Officer of the
company. Please also
revise the Security Ownership table on page 43 to include Mr. Gould
and to add a row for
the directors and executive officers of the registrant as a group,
without naming them.
Refer to Item 403 of Regulation S-K.
Item 16. Exhibits and Financial Statement Schedules, page 47
10. We note your disclosure on page 37 that you have entered into an
agreement with ADM
Tronics, Inc. and your disclosure on page F-8 that you entered into a
series of agreements
with Diopsys, Inc., including an option exchange agreement that you
intend to file as an
exhibit according to the exhibit index. We also note your disclosure
on page F-15 that
you have entered into an agreement with Benchmark Financial. Please
file all of these
agreements as exhibits and disclose their material terms in the
Business section to the
extent that you have not already done so or tell us why you are not
required to do so.
Refer to Item 601(b)(10) of Regulation S-K.
Retinalgenix Technologies, Inc.
Notes To Financial Statements
Note 5. Income (Loss) Per Common Share, page F-10
11. Please disclose the number of shares potentially issuable to Diopsys,
Inc. and the specified
milestone that would trigger the issuance.
General
12. 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.
Jerry Katzman
RetinalGenix Technologies Inc.
March 17, 2021
Page 4
You may contact Sasha Parikh at 202-551-3627 or Al Pavot at 202-551-3738
if you have
questions regarding comments on the financial statements and related matters.
Please contact
Dillon Hagius at 202-551-7976 or Ada D. Sarmento at 202-551-3798 with any other
questions.
Sincerely,
FirstName LastNameJerry Katzman
Division of
Corporation Finance
Comapany NameRetinalGenix Technologies Inc.
Office of Life
Sciences
March 17, 2021 Page 4
cc: Richard Friedman, Esq.
FirstName LastName