View:
United States securities and exchange commission logo
August 20, 2021
Neil Dey
Chief Executive Officer and President
Bluejay Diagnostics, Inc.
360 Massachusetts Avenue, Suite 203
Acton, MA 01720
Re: Bluejay
Diagnostics, Inc.
Draft Registration
Statement on Form S-1
Submitted July 22,
2021
CIK No. 0001704287
Dear Mr. Dey:
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
Industry and Market Data, page 0
1. Your statements that:
(i) you have not independently verified the accuracy or
completeness of third
party data, (ii) your internal research has not been verified by any
third party and (iii)
investors are cautioned not to give undue weight to any such
information,
projections, and estimates may imply an inappropriate disclaimer of
responsibility with
respect to the third party information and internal research. Please
either delete these
statements or specifically state that you are liable for such information.
Neil Dey
FirstName LastNameNeil
Bluejay Diagnostics, Inc. Dey
Comapany
August 20, NameBluejay
2021 Diagnostics, Inc.
August
Page 2 20, 2021 Page 2
FirstName LastName
Prospectus Summary, page 1
2. We note your disclosure that your product may provide a market
solution "if cleared,
authorized, or approved by the U.S. Food and Drug Administration."
Please revise to
clearly disclose, if true, that you intend to label and distribute
Symphony as an RUO
product in the U.S. while you pursue 510(k) clearance from the FDA to
use Symphony
for in vitro diagnostic use.
3. Please revise your disclosure here and in the Business section to
provide appropriate
context for various conclusions and predictions as to the performance
of your product
candidates and revise and/or remove any statements that imply safety
or efficacy as safety
and efficacy determinations are solely within the authority of the FDA
or similar foreign
regulators. For example, we note statements that RUO use in Japan has
resulted in
"validation of the symphony platform," that results from your device
"appear to be as
accurate as those performed in a laboratory," that your diagnostic
product "provide[s]
results within 20 minutes," "reduces test result time from days to
minutes" and your
product candidate "will eliminate the number of operational
touch-points from sample-
to-result from six to two." Please revise this disclosure and
similar statements throughout
your prospectus to remove any suggestion that there is an expectation
that your product
candidate will be effective or will have improved performance. You may
provide a
summary of the data that you used to draw these conclusions but not
the conclusions or
predictions, and such discussion is more appropriate in the Business
section where full
and proper context can be provided.
4. We note your disclosure that you are "positioned now to complete the
last regulatory
stages of development needed to move to commercialization in the
United States." Please
revise to clarify where you currently are in the regulatory process
and the material steps
that you need to complete, including, if applicable, any clinical
trials that must be
conducted or regulatory applications that must be submitted.
5. We note your disclosure that Toray Industries is your development
partner and investor.
Please revise to explain the nature of Toray Industries' investment in
your company.
Based on your disclosure, it appears that Toray serves as a licensor
and supplier
only. Please also revise your summary to clearly state that you
license the core technology
used in your Symphony platform and test cartridge product candidates
from Toray
Industries.
6. Please revise the Prospectus Summary and Risk Factors to highlight the
auditor's
explanatory paragraph regarding your ability to continue as a going
concern. Your
disclosures should describe the potential consequences to your
business if you are unable
to raise additional financing.
Neil Dey
FirstName LastNameNeil
Bluejay Diagnostics, Inc. Dey
Comapany
August 20, NameBluejay
2021 Diagnostics, Inc.
August
Page 3 20, 2021 Page 3
FirstName LastName
Use of Proceeds, page 27
7. We note your disclosure that you intend to use approximately $5.0
million to obtain
regulatory approvals. Please revise to disclose for which product
candidates you intend to
seek regulatory approval, in which jurisdictions and through which
regulatory
pathway using the proceeds from this offering.
Business
Our Symphony Platform, page 42
8. We note your disclosure that the Symphony platform is an innovative
and proprietary
technology platform that in clinical trials appears to provide rapid,
highly sensitive,
accurate, and simple measurements of key diagnostic biomarkers found
in whole blood.
Please revise to clarify if these clinical trials were conducted by
the Company or a third
party. Please also expand your disclosure to include a description of
how the clinical trials
were conducted and the results observed that would support the above
statement.
Manufacturing, page 44
9. Please revise to highlight that pursuant to your agreement with Toray
Industries, you are
required to use Toray to manufacture test cartridges for a period of
three years.
Regulatory Strategy, page 45
10. Please provide the basis for your statement that your Symphony IL-6
product candidate
could also be used with confirmed COVID-19 illness. Please revise to
disclose whether
you have tested your product candidate for this indication and, if so,
disclose the results of
such testing.
11. We note your disclosure that your clinical studies are being conducted
at The University
of Texas, Southwestern Medical Center, Dallas, Texas and Parkland
Clinic, Dallas, Texas.
Please revise to disclose how many trials are being conducted and for
each trial being
conducted when the trial began, the current status of the trial and
when you expect the trial
to be completed.
Neil Dey
FirstName LastNameNeil
Bluejay Diagnostics, Inc. Dey
Comapany
August 20, NameBluejay
2021 Diagnostics, Inc.
August
Page 4 20, 2021 Page 4
FirstName LastName
12. With respect to your table on page 46 showing your expected timeline
for your product
candidates, it appears to be premature and speculative to provide the
estimated time to
market for your product candidates given that it appears that you have
yet to complete
material steps in order to commercialize your product candidates.
Please revise this table
to provide the status of FDA approval of your various product
candidates, including
clinical trials or studies you must complete, when you began clinical
trials or studies and
when you expect to complete them and whether you have submitted or
when you intend to
submit an application for approval to the FDA. Please also explain to
us why you have not
included Toray Industries next to your Symphony IL-6 product
candidates. In this
regard, we note that you license technology related to Symphony and
the detection
cartridges.
Intellectual Property, page 47
13. We note that you do not currently hold any patents directly but that
you have an exclusive
license with Toray to use their patents and know-how related to your
Symphony platform
and test cartridges. Please revise your intellectual property
disclosure to clearly identify
each material licensed patent or patent family, the type of patent
protection granted for
each technology such as composition of matter, use or process, the
specific products or
product candidates, product groups and technologies dependent on each
patent, and the
patent expiration dates and applicable jurisdictions, including any
foreign jurisdictions.
License Agreement, page 47
14. We note that you intend to file as an exhibit a Lease and Supply
Agreement with Toray
Industries. If this is not the license agreement that you have with
Toray Industries, please
file the license agreement as an exhibit to your registration
statement pursuant to Item
601(b)(10) of Regulation S-K.
15. We note your disclosure that you are required to pay a 15% royalty fee
based on a
percentage of Net Sales of products. Please revise to disclose
the royalty term.
Description of Our Securities, page 72
16. We note that you refer shareholders to, in part, the applicable
provisions of the Delaware
General Corporation Law. It is not appropriate to qualify your
disclosure by reference to
information that is not included in the filing or filed as an exhibit.
Please revise
accordingly.
Recent Sales of Unregistered Securities., page II-2
17. Please revise your disclosure to name the persons or identify the
class of persons to whom
the securities were sold. Refer to Item 701(b) of Regulation S-K.
Neil Dey
FirstName LastNameNeil
Bluejay Diagnostics, Inc. Dey
Comapany
August 20, NameBluejay
2021 Diagnostics, Inc.
August
Page 5 20, 2021 Page 5
FirstName LastName
General
18. Please 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.
You may contact Sasha Parikh at 202-551-3627 or Vanessa Robertson at
202-551-3649 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Deanna Virginio at 202-551-4530 or Ada D. Sarmento at 202-551-3798 with
any other
questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Cavas S. Pavri, Esq.