March 10, 2020
Jay R. Venkatesan
Chief Executive Officer
Angion Biomedica Corp.
1700 Montgomery Street, Suite 108
San Francisco, CA 94111
Re: Angion Biomedica Corp.
Draft Registration Statement on Form S-1
Submitted February 14, 2020
CIK No. 0001601485
Dear Dr. Venkatesan:
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 filed February 14, 2020
Prospectus Summary
Overview, page 1
1. We note your disclosure on page 2 detailing the "specific advantages" of
ANG-3777.
Because ANG-3777 has not been approved by the FDA or foreign government
equivalent,
please revise to refer to them as possible or potential advantages.
Similarly, revise your
disclosure on page 100. In addition, we note your disclosure on page 2,
100 and 113 that
ANG-3777 demonstrated "clinically meaningful improvements" on several
key
endpoints. Please clarify whether these results were statically
significant and disclose the
p-value used to determine significance. Also, clarify whether all of the
endpoints in your
Phase 2 clinical trial for DGF with ANG-3777 were met.
Jay R. Venkatesan
FirstName LastNameJay R. Venkatesan
Angion Biomedica Corp.
Comapany2020
March 10, NameAngion Biomedica Corp.
Page 2
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FirstName LastName
2. We note your disclosure on page 3 that "[t]here are currently two
approved drugs for the
treatment of IPF, which despite having significant side-effects,
generated approximately
$2.3 billion in combined 2018 worldwide sales." Please revise your
disclosure here and
throughout to clarify that, even if your product candidate is approved
by the FDA for IPF,
there is no guarantee that your product candidate will generate
comparable revenues to the
two currently approved drugs.
Implications of Being an Emerging Growth Company, page 5
3. 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.
Use of Proceeds, page 72
4. We note your disclosure that you intend to use net proceeds to fund
your (1) ongoing
Phase 3 registration trial of ANG-3777 for DGF, (2) development and
validation of your
commercial manufacturing process for ANG-3777 in preparation for the
NDA
submission, (3) ongoing Phase 2 clinical trial of ANG-3777 for
CSA-AKI, (4) ongoing
Phase 1 clinical trial of ANG-3070 and preparation for subsequent
clinical development,
and (5) research and development efforts, including ongoing studies of
your ROCK2
inhibitor. Please specify how far in the development of each of the
listed clinical trials or
programs you expect to reach with the proceeds of the offering. If any
material amounts of
other funds are necessary to accomplish the specified purposes, state
the amounts and
sources of other funds needed for each specified purpose and the
sources. Refer to
Instruction 3 to Item 504 of Regulation S-K.
Research and Development Expenses, page 87
5. You disclosed multiple drug candidates with multiple indications at
various stages and
that research and development is a significant aspect of your
business. You also disclosed
on page 89 that your R&D expenses for the year ended December 31, 2018
are primarily
related to ANG-3777. For each period presented, please expand to
provide more detail for
your research and development expenses, to the extent available,
including but not limited
to, detail by drug candidates and/or by indications, as well as by the
nature and sources
(for example, internal or external) of the expenses.
6. You disclose that research and development expenses include costs
related to the
protection of intellectual property rights. Please clarify for us and
revise if necessary, the
nature of these costs and how these costs are properly classified as
research and
development under ASC 730-10-55-2(i), which requires that legal work
in connection
with patent application or litigation, and the sale or licensing of
patents would not be
considered research and development within the scope of this topic.
7. You disclose here that you do not record indirect research and
development expenses by
Jay R. Venkatesan
Angion Biomedica Corp.
March 10, 2020
Page 3
product. Please clarify for us and revise if necessary, the nature of
your indirect costs and
whether you record them as research and development expenses under ASC
730.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Critical Accounting Policies and Significant Judgement and Estimates
Share-Based Compensation, page 95
8. 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 IPO and the estimated offering price. This information will
help facilitate our
review of your accounting for equity issuances, including stock
compensation.
ANG-3777 for the Reduction in Severity of Delayed Graft Function
Phase 2 Clinical Trial, page 113
9. Please revise your disclosure for the second graph on pages 114 and
the graph on page
115 to disclose whether the results were statistically significant and
the p-values used to
determine statistical significance.
Our Business
ANG-3777 Phase 1 and Preclinical Results, page 117
10. Please revise here and throughout to remove conclusory statements
regarding the results
of your clinical and preclinical trials for ANG-3777and ANG-3070, and
provide detailed
disclosure regarding the tests conducted, including the number of
tests conducted, the
number of test subjects in each cohort, the range of results observed
in each, whether the
results were statistically significant and the p-value used to
determine statistical
significance. For example, we note your disclosure on page 118 that
"you have
demonstrated in different animal models of organ injury that
intervention with ANG-3777
following a 24-hour delay in the administration of the first dose
appears to be as
efficacious as intervening with ANG-3777 either prophylactically or at
the time of the
initial injury" and on page 119 that you have "consistently
demonstrated activity across
different species, organ system, and acute organ injuries due to a
variety of causes." Also,
please provide a brief definition of the term "basket trial" on page
124.
Management
Director Compensation, page 151
FirstName note your disclosure regarding your consultant agreement with Dr.
Yamin. If this
11. We LastNameJay R. Venkatesan
agreement is still in effect, please file it as an exhibit to your
registration statement.
Comapany NameAngion Biomedica Corp.
March 10, 2020 Page 3
FirstName LastName
Jay R. Venkatesan
FirstName LastNameJay R. Venkatesan
Angion Biomedica Corp.
Comapany2020
March 10, NameAngion Biomedica Corp.
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March 10, 2020 Page 4
FirstName LastName
Part II
Item 16. Exhibits and Financial Statement Schedules, page II-4
12. Please file the commercial supply agreement with your current
third-party supplier,
Alcami, Inc., as described on pages 40 and 124, or tell us why you
believe it is not
required to be filed.
General
13. Please revise throughout to remove any inference that your product
candidates have been
or will ultimately be determined to be safe or effective, as only the
FDA and foreign
government equivalent regulators have the authority to make these
determinations. We
note, by way of example, the statements on page 113 that you have
demonstrated in
different animal models of organ injury that intervention with
ANG-3777 following a 24-
hour delay in the administration of the fist does appears to be
efficacious, on page 119
that "ANG-3777 has been shown in preclinical in vivo models to be
effective ... ." and on
page 125 that "the key competitive factors affecting the development
and commercial
success of [your] product candidates are efficacy, safety... ."
You may contact Li Xiao at (202) 551-4391 or Terence O'Brien,
Accounting Branch
Chief, at (202) 551-3355 if you have questions regarding comments on the
financial statements
and related matters. Please contact Tonya K. Aldave at (202) 551-3601 or Sonia
Bednarowski at
(202) 551-3666 with any other questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Miles P. Jennings, Esq.