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United States securities and exchange commission logo
June 4, 2020
Axel Bolte
President and Chief Executive Officer
Inozyme Pharma, Inc.
321 Summer Street
Suite 400
Boston, Massachusetts 02210
Re: Inozyme Pharma,
Inc.
Draft Registration
Statement on Form S-1
Submitted May 8,
2020
CIK No. 0001693011
Dear Mr. Bolte:
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.
Registration Statement on Form S-1
Company Overview, page 1
1. We note your disclosure
here and throughout that you are pursuing the development of
potentially
"first-in-class" therapeutics. That term may suggest that your product
candidates are
effective, likely to be approved and favorable as compared to competitive
products and product
candidates. Given the status of development, it is premature for you
to make such statements
or implications at this time. Accordingly, please revise to
remove any disclosure
in your registration statement regarding your therapeutics as being
potentially
"first-in-class."
Axel Bolte
FirstName LastNameAxel Bolte
Inozyme Pharma, Inc.
Comapany NameInozyme Pharma, Inc.
June 4, 2020
Page 2
June 4, 2020 Page 2
FirstName LastName
Pathological Diseases of Abnormal Mineralization, page 1
2. We note that your disclosure in the third paragraph on page 3
indicates the number of
patients with the enzyme deficiencies you are targeting are based on
worldwide estimates.
Since you currently intend to seek regulatory approval for your
products in the United
States and Europe, please revise to clarify your market opportunity in
those targeted
markets or clarify your risks in that regard.
Our Solution: INZ-701, page 2
3. You state at the bottom of page three, "[t]here are currently no
approved therapies for
calciphylaxis," and address it as "a particularly attractive area for
drug development for
abnormal mineralization," and include it in your pyramid graphic as a
place for significant
expansion of your product candidates (visually, as one of the widest
portions of the
graphic, even if the calculations underlying the potential market do
not meet the visual
depiction). On pages 30 and 131, however, you disclose you have
competition in
the calciphylaxis area, stating "SNF472, a calcification inhibitor, is
currently in Phase 3
clinical development for calciphylaxis by Sanifit, and Inositec has
product candidates in
preclinical development for calcification inhibitors." Revise your
summary to balance
your emphasis on this potential indication against the realities you
describe elsewhere.
4. In the pyramid graphic and pipeline table on pages 4, 110, and 112,
you include INZ-701
in different forms for treating ENPP1 deficiency in both adults and
children and ABCC6
deficiency, and also for potential applications still in discovery
stage. Please revise the
pyramid graphic and pipeline table to include only those programs that
are material to the
company. If you believe that every program listed is material, please
provide us with an
analysis explaining your belief. In your response, address the import
of including the
pyramid graphic, which appears to only convey that you wish to grow
your business, and
repeats information included in your summary while emphasizing
potential applications
for which you are still in the discovery phase. In addition, you do
not separately address
the pediatric and adult applications of IND-701 for ENPP1 deficiency
when discussing
your IND applications in your use of proceeds or when you address your
strategy for
advancing your products. If these are not distinct products revise the
table to make this
clear. Finally, revise the pipeline table to provide some indication
of the timing of
applications for IND or CTA in order to provide a more complete view
of the stage of
your potential products relative to the entire approval process.
5. Revise the summary to include your intent to conduct the clinical
trials for your products
outside the U.S., and to highlight the associated risks, as noted on
page 26.
6. We note your disclosure in the second to last paragraph of this
section that you plan to
engage with the regulatory authorities in the United States, Europe
and other jurisdictions
to determine appropriate primary efficacy endpoints and other
requirements for potential
marketing approval. Please balance this disclosure by disclosing that
you may propose
new or novel endpoints and may be unable to establish clinical
endpoints that the
Axel Bolte
FirstName LastNameAxel Bolte
Inozyme Pharma, Inc.
Comapany NameInozyme Pharma, Inc.
June 4, 2020
Page 3
June 4, 2020 Page 3
FirstName LastName
applicable regulatory authorities would consider clinically
meaningful.
Pipeline, page 4
7. Above the pipeline table and elsewhere, you address your "pipeline and
programs,
including INZ-701." The table and elsewhere only features INZ-701. If
you do not have
other material product candidates to disclose, revise your disclosure
throughout to clarify.
8. Revise your summary to clarify that you are licensing your technology
from Yale and that
it is contingent on your continued relationship with Yale and Dr.
Braddock, as disclosed
on page 132 and elsewhere in the prospectus.
Our Team, page 5
9. We note your disclosure here and on page 110 regarding the "leading"
investors providing
your funding, and on page 111 related to the "leading" clinicians with
whom you work.
Revise to clarify what makes the investors and clinicians "leading" or
delete these
references.
Risk Factors, page 12
10. We note the risk factor related to orphan drug designation on pages
57-58. In the heading,
you address orphan drug designation by both the FDA and EMA; however,
in the body of
the risk factor, you do not address risks related to EMA orphan drug
designation. Please
revise to address those risks.
Use of Proceeds, page 81
11. You list your use of proceeds as: (1) "for the completion of our IND
submission and
conduct of our Phase 1/2 clinical trial of INZ-701 for ENPP1
deficiency;" and (2) "for the
completion of our CTA submission and conduct of our Phase 1/2 clinical
trial of INZ-
701 for ABCC6 deficiency," as well as additional uses. We note these
activities addressed
on page 129. Please disclose the significance of receiving orphan drug
designation from
the CTA for the treatment of ENPP1 deficiency (as stated on page 108)
if you do not plan
to pursue those clinical trials in connection with your CTA submission
and clarify whether
you will use a material portion of the proceeds to amend and resubmit
INZ-701 to the
FDA for orphan drug designation for the treatment of ABCC6 deficiency.
In addition, we
note the risk factor disclosure that you may seek Rare Pediatric
Disease Designation for
either of your product candidates. Please disclose whether you intend
to use any of the
proceeds to seek this designation. We note that designation would need
to be achieved
before September 30, 2020, as disclosed on page 58. We note it appears
that application
would likely need to be made by July 31, 2020 to potentially obtain a
response by
September 30, per the FDA's website. If you have no current plans,
advise whether this
risk factor disclosure is relevant, or may be relevant by the time
this registration statement
becomes effective.
Axel Bolte
Inozyme Pharma, Inc.
June 4, 2020
Page 4
Management's Discussion and Analysis
License and Sponsored Research Agreements, page 91
12. Here and on page 132, revise the disclosure regarding the
"double-digit" percentages you
must pay to Yale on certain types of income you receive from
sublicensees to disclose a
range within ten percentage points.
Business
INZ-701: Preclinical Results and Data, page 121
13. On page 125, you state, "Treatment with 5 mg/kg of INZ-701 completely
prevented
calcification in the heart and aorta." If you tested the same number
of mice at each dosage
level, there appears to be a subject that was dosed at 5mg/kg missing
from the graphic.
Please revise to clarify. We also note that you do not appear to
disclose a p-value
associated with the results shown in the graphic. If the results shown
could be due to
chance, please revise to make that clear.
Consulting Agreement with Demetrios Braddock, page 182
14. As your ability to maintain your agreement with Dr. Braddock appears
to be the key to
your Yale licensing agreement, provide the consulting agreement with
Dr. Braddock as an
exhibit in accordance with Regulation S-K Item 601(b)(10)(ii)(B).
Exclusive Forum Selection, page 190
15. We note that your forum selection provision identifies the Court of
Chancery of the State
of Delaware (or, if the Court of Chancery of the State of Delaware
does not have
jurisdiction, the federal district court for the District of Delaware)
as the exclusive forum
for certain litigation, including any "derivative action." Please
disclose whether this
provision applies to actions arising under the Securities Act or
Exchange Act. If the
provision applies to Securities Act claims, please state that
investors cannot waive
compliance with the federal securities laws and the rules and
regulations thereunder. In
that regard, we note that Section 22 of the Securities Act creates
concurrent jurisdiction
for federal and state courts over all suits brought to enforce any
duty or liability created by
the Securities Act or the rules and regulations thereunder. If this
provision does not apply
to actions arising under the Securities Act or Exchange Act, please
ensure that the
exclusive forum provision in the governing documents states this
clearly.
General
16. Please supplementally provide us with copies of all written
communications, as defined in
FirstName LastNameAxel Bolte
Rule 405 under the Securities Act, that you, or anyone authorized to do
so on your behalf,
Comapany NameInozyme Pharma, Inc.reliance on Section 5(d) of the Securities
Act, whether or
present to potential investors in
June 4,not they retain copies of the communications.
2020 Page 4
FirstName LastName
Axel Bolte
FirstName LastNameAxel Bolte
Inozyme Pharma, Inc.
Comapany NameInozyme Pharma, Inc.
June 4, 2020
Page 5
June 4, 2020 Page 5
FirstName LastName
You may contact Gary Newberry at (202) 551-3761 or Jeanne Baker at (202)
551-3691 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Abby Adams at (202) 551-6902 or Tim Buchmiller at (202) 551-3635 with
any other
questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Brian A. Johnson, Esq.