United States securities and exchange commission logo
March 10, 2023
Jennifer J. Rhodes, Esq.
General Counsel
Angion Biomedica Corp.
51 Charles Lindbergh Boulevard
Uniondale, New York 11553
Re: Angion Biomedica
Corp.
Registration
Statement on Form S-4
Filed February 13,
2023
File No. 333-269741
Dear Jennifer J. Rhodes:
We have reviewed your 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 amending your registration
statement and providing the
requested information. 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 any amendment to your registration statement and
the information you
provide in response to these comments, we may have additional comments.
Registration Statement on Form S-4
Questions and Answers about the Merger, page 1
1. Please include a
question and answer that addresses the material U.S. federal income tax
consequences, if any,
of the Merger to Angion stockholders.
What are the material U.S. federal income tax consequences of the Merger
to U.S. holders of
Elicio shares?, page 5
2. We note your
representation on page 5, and beginning on page 123, that Angion and
Elicio "intend" the
merger to qualify as a reorganization within the meaning of Section
368(a) of the U.S.
Internal Revenue Code of 1986, as amended (the "Code"). Please
revise your disclosure
here and throughout to provide counsel s firm opinion for each
material tax
consequence, including whether the Merger will qualify as a reorganization,
Jennifer J. Rhodes, Esq.
FirstName LastNameJennifer J. Rhodes, Esq.
Angion Biomedica Corp.
Comapany
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10, 2023
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or to explain why such opinion cannot be given. If the opinion is
subject to uncertainty,
please (1) provide an opinion that reflects the degree of uncertainty
(e.g., "should" or
"more likely than not") and explains the facts or circumstances giving
rise to the
uncertainty, and (2) provide disclosure of the possible alternative
tax consequences
including risk factor and/or other appropriate disclosure setting
forth the risks of uncertain
tax treatment to investors. Please refer to Item 601(b)(8) of
Regulation S-K and Section
III.A. of Staff Legal Bulletin 19, Legality and Tax Opinions in
Registered Offerings.
Nasdaq Stock Market Listing, page 17
3. Please disclose whether the merger is conditioned upon receiving
Nasdaq listing approval
to trade on the The Nasdaq Global Market. Also disclose whether the
terms of the merger
agreement permit this closing condition to be waived without
recirculation or
resolicitation. In this regard, we note that the disclosure on page
126 seems to indicate
that this condition could be waivable.
Risk Factors
Elicio's success will depend upon intellectual property and proprietary
technologies...., page 62
4. Please expand this risk disclosure to make it clear that Elicio does
not currently own any
patents. In this regard, we note your disclosure on page 203 that
Elicio does not own any
issued patents covering clinical product candidates and the patent
portfolio owned by
Elicio currently comprises only applications.
Risk Factors
The certificate of incorporation of the combined company will provide that the
Court of
Chancery..., page 84
5. We note your disclosure that the combined company s amended and
restated certificate of
incorporation and amended and restated bylaws will also provide the
federal district courts
of the United States of America will be the exclusive forum for the
resolution of any
complaint asserting a cause of action against the combined company or
any of its
directors, officers, employees, or agents and arising under the
Securities Act. Please
disclose that there is uncertainty as to whether a court would enforce
such a provision.
Please also 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. Additionally, please revise to note that this
provision may also
make it more costly for a shareholder to bring a claim against you.
The Merger
Angion Reasons for the Merger, page 105
6. We note your disclosure in the fourth bullet point of the second
paragraph. In an
Jennifer J. Rhodes, Esq.
FirstName LastNameJennifer J. Rhodes, Esq.
Angion Biomedica Corp.
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appropriate location, please expand your disclosure to provide
material information on
the clinical and scientific diligence and analysis process that formed
the basis for the
Angion Board's belief as to the market opportunity for Elicio s
product candidates.
Opinion of Angion's Financial Advisor, page 109
7. For the disclosure under "Selected Public Companies Analysis" and
"Selected Precedent
Initial Public Offering Analysis," revise to describe in more detail
the underlying
methodology and selection criteria used for selecting the companies
listed for comparison
purposes, including the general characteristics of the selected
companies such as the
number of product candidates in the pipeline, stage of clinical
development, total
addressable market and how those companies compared to Elicio.
8. Please supplementally provide us with copies of all materials prepared
by Oppenheimer
and shared with your board of directors and their representatives,
including any board
books, transcripts and summaries of oral presentations, that were
material to the board's
decision to approve the merger and the transactions contemplated
thereby.
Certain Unaudited Financial Projections, page 114
9. With respect to the Financial Projections:
Disclose and explain the bases for and the nature of the
material estimates and
assumptions that underlie the line items presented in the
Financial Projections
summary table. Please ensure that the level of detail provided is
sufficient for an
investor to evaluate and understand the reasonableness of the
estimates, assumptions,
uncertainties and/or variables underlying the Financial
Projections as well as the
inherent limitations on the reliability of the Financial
Projections in order to make
informed voting and investment decisions. As to the Total Global
Revenue line item,
please specifically address the growth rates as well as identify
the material product
revenue streams underlying these projections and the date you
assume Elicio will be
granted regulatory approval for each indication for each
significant market reflected
in the Total Global Revenue forecast.
You note on page 115 that the Financial Projections cover
multiple years, and that
this information by its nature becomes subject to greater
uncertainty with each
successive year. With respect to the length of the projections,
please disclose the
basis for projections beyond year five, including if the
forecasts reflect more than
straight line growth assumptions. Explain how management and the
Angion board
relied upon the Financial Projections and how they determined
that they are
reasonable, particularly in light of the extensive length of the
forecasts and since
Elicio is a clinical stage company with no approved products to
date and the
uncertainty regarding regulatory approvals. Specifically, address
the reliability of the
projections related to the later years presented.
Jennifer J. Rhodes, Esq.
FirstName LastNameJennifer J. Rhodes, Esq.
Angion Biomedica Corp.
Comapany
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10, 2023
March4 10, 2023 Page 4
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You disclose that "Elicio's management prepared a preliminary
internal financial
forecast for Elicio, which Angion's management adjusted to
reflect certain
assumptions applicable to Elicio's assets as well as to Elicio's
expenses based on
industry metrics consistent with the experience and judgment of
Angion's
management and the Angion Board." Please describe in more detail
the process
undertaken to formulate the forecasts and the parties who
participated in the
preparation of the forecasts. Explain and quantify the
adjustments that Angion's
management made to the initial forecasts provided by Elicio and
the reasons for the
adjustments, including how Angion's management and board were in
a position to
make adjustments to Elicio's preliminary internal financial
forecasts given the
different natures of Angion's and Elicio's businesses and product
development efforts.
Disclose your assumptions as to which product candidates were
assumed to have
received approvals and identify the assumed regulatory
jurisdictions in which they
received such approvals by period. Clearly disclose the
limitation that regulatory
approval is outside of your control.
We note the Financial Projections cover a period through 2039.
Please indicate the
basis for why you believe that this period is a reasonable period
to project. For
example, if that period is tied to expected patent protections,
please make the material
assumptions underlying that basis clear.
We note the risks described under the caption "Any future
product candidates for
which Elicio intends to seek approval as biologic products may
face competition
sooner than anticipated" on page 46. Since the Financial
Projections cover a period
through 2039, please disclose whether the Financial Projections
factored in any of
those risks.
Miscellaneous, page 114
10. We note your disclosure that "[a]s Angion was aware and as was
disclosed to the Angion
Board on January 13, 2023 in connection with rendering the opinion of
Oppenheimer,
Daniel Geffken, the Chief Financial Officer and a member of the Elicio
Board, was also
the Chief Financial Officer for OPY Acquisition Corp. I (OPY1), and
the sponsor of
OPY1 was an affiliate of Oppenheimer." If this relationship created a
potential source for
a conflict of interest, please explain the nature of the potential
conflict in clearer terms and
how Angion's board viewed that potential source of conflict. Also, we
note that Mr.
Geffken is referred to in this section as the Chief Financial Officer
of Elicio but elsewhere
as the Interim Chief Financial Officer. Please revise for consistency.
Description of Angion's and Merger Sub's Business
Angion's ROCK2 Inhibitor Program, page 177
11. For each patent family, please specify the type of patents or pending
patents (e.g.,
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Angion Biomedica Corp.
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composition of matter, method of use or process) for Angion s Rock2
Inhibitor Program.
Description of Elicio's Business
Overview, page 181
12. Please revise your disclosure to clarify the meaning of any
significant scientific or
technical terms or acronyms the first time they are used in order to
provide context for
such terms and better ensure that lay readers will understand the
disclosure. By way of
example, we note the usage of "PDAC" and "CRC" on page 9 and 181.
13. We note the disclosure in the last full paragraph on page 181 that
"Elicio is demonstrating
its lymph node targeting technology can create effective
therapeutics...." As safety and
efficacy determinations are solely within the authority of the FDA and
comparable
regulatory bodies, it is too early to state or imply that product
candidates are safe
or effective. Please revise your disclosure as appropriate.
14. With respect to Elicio's scientific advisory board, if material,
please include disclosure in
an appropriate location that describes the role or function of the
scientific advisory board,
and indicates whether there are any rules or procedures governing this
board. Please also
disclose how members of the scientific advisory board are compensated.
Elicio's Pipeline, page 182
15. Please revise Elicio's pipeline table to include a column for Phase 3.
We also note that
you have two programs that have undisclosed product candidates. Please
explain to us
why each of those programs is sufficiently material to Elicio's
business to warrant
inclusion in the pipeline table at this time or revise your table as
appropriate.
16. We note your disclosure in the last full paragraph on page 181 that
examples of mutant
BRAF-driven and TP53-expressing cancers include melanoma, CRC, and
NSCLC. Given
that disclosure, please tell us why the indications for ELI-008 and
ELI-007 are
"Undisclosed" or revise the pipeline table to include the indications.
17. From your disclosure on page 190 under the heading "ELI-002 Clinical
Development
Program" it appears that Elicio has two trials underway: (1) the Phase
1 AMPLIFY-201
trial with a 2-peptide (2P) formulation, and (2) the Phase 1/2
AMPLIFY-7P, using the 7-
peptide formulation of ELI-002. Please tell us whether presenting each
of these trials in
the pipeline table separately would be appropriate. We note in this
regard that the arrow
for ELI-002 in the current pipeline table could be interpreted as
indicating Elicio is close
to the end of Phase 1 rather that at the initial or middle stages of
Phase 1 in these trials.
Please ensure your arrows align with your disclosure.
18. We note your disclosure on page 194 that the combination trial of
ELI-002 and
cemiplimab, called "AMPLIFY-202," will be conducted by Elicio and is
expected to
begin after the Phase 1a safety evaluation portion of AMPLIFY-7P
completes. Given this
disclosure, please tell us why the arrow for ELI-002 + cemiplimab
indicates that trial is
Jennifer J. Rhodes, Esq.
FirstName LastNameJennifer J. Rhodes, Esq.
Angion Biomedica Corp.
Comapany
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half way through Phase 1 or revise as appropriate. We also note your
disclosure that this
trial is conditioned upon the receipt of additional funding. Please
disclose if the cash
acquired in the proposed merger will be sufficient to commence this
trial after the Phase
1a safety evaluation portion of AMPLIFY-7P completes or clarify that
future funding
beyond the merger may be required.
19. Please revise the pipeline table and footnotes to ensure that the text
is readable.
The results of Elicio's preclinical studies have provided evidence of ELI-002
activity against
KRAS mutations, page 188
20. We note your disclosure that when vaccinated mice were infused with
mKRAS-pulsed
target cells, only those who had received AMP vaccines were able to
generate an mKRAS
G12D-specific cytotoxic response and that in those animals,
approximately 50% of
mKRAS-target cells were eliminated over the course of 16 hours, while
comparator
vaccines were inactive. We also note your disclosure that one of the
challenges of current
immunotherapies is that the tumor environment is compounded by the
difficulties of T cell
infiltration into the tumor microenvironment and mechanisms by which
tumor cells evade
detection by the immune system. Please indicate whether you generated
any preclinical
data that indicated cytotoxic activity against solid tumors, or if the
studies were limited to
mKRAS-pulsed target cells, clarify the extent to which the results
described in this section
may not be applicable to solid tumors in humans and indicate whether
immunosuppressive
effects were studied or observed. Please also disclose the number of
mice that were dosed
and indicate whether the observed 50% elimination rate was
statistically significant.
AMPLIFY-7P: A Phase 1/2 clinical trial of ELI-002, page 192
21. We note your disclosure that the Phase 2 portion of this trial is
conditioned upon the
receipt of additional funding. Please disclose if the cash acquired in
the proposed merger
will be sufficient to commence the Phase 2 portion of this trial or
clarify that future
funding beyond the merger may be required.
ELI-004: Elicio s Universal Adjuvant, page 197
22. We note your disclosure that "few serious adverse events have been
observed." Please
specify the number and the types of such serious adverse events.
AMP Immune Cell Therapy AMP-lifiers, page 200
23. Please revise throughout to remove any inference regarding regulatory
approval or the
safety and efficacy of your product candidates or explain to us why
these statements are
appropriate given the stage of your product candidates. By way of
example only, we note
the disclosure on page 200 regarding preclinical trials that promoted
therapeutic efficacy.
Please remove these statements, and any similar statements, as
conclusions of safety and
efficacy are within the sole authority of the FDA and comparable
foreign regulators.
Jennifer J. Rhodes, Esq.
Angion Biomedica Corp.
March 10, 2023
Page 7
Future Cash Needs and Funding Requirements, page 236
24. We note your references in the third and sixth bullet points to ongoing
clinical trials of
ANG-3070. However, we note your disclosure on page 174 that Angion
suspended the
advancement of ANG-3070 in clinical studies. Please revise to reconcile
your disclosure.
Exhibits
25. We note the statement in Exhibit 99.1 that Oppenheimer "disclaim[s] that
we come within
the category of persons whose consent is required under Section 7 of the
Securities Act of
1933, as amended, or the rules and regulations of the Securities and
Exchange
Commission promulgated thereunder, nor do we admit that we are experts
with respect to
any part of the Registration Statement within the meaning of the term
'experts' as used in
the Securities Act or the rules and regulations promulgated thereunder."
Please have
Oppenheimer revise the consent to remove this disclaimer, as it appears
that Oppenheimer
is required to provide a consent under Section 7 of the Securities Act
because it provided
an opinion that is summarized in and included in the registration
statement and which is
attributed to Oppenheimer.
We remind you that the company and its management are responsible for
the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action
or absence of
action by the staff.
Refer to Rules 460 and 461 regarding requests for acceleration. Please
allow adequate
time for us to review any amendment prior to the requested effective date of
the registration
statement.
You may contact Christine Torney at 202-551-3652 or Lynn Dicker at
202-551-3616 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Jimmy McNamara at 202-551-7349 or Tim Buchmiller at 202-551-3635 with
any other
questions.
Sincerely,
FirstName LastNameJennifer J. Rhodes, Esq.
Division of
Corporation Finance
Comapany NameAngion Biomedica Corp.
Office of Life
Sciences
March 10, 2023 Page 7
cc: Brett D. White, Esq.
FirstName LastName