# EDGAR Filing Document

**Accession Number:** 0001601485
**File Stem:** 0000000000-23-002386
**Filing Date:** 2023-3
**Character Count:** 41506
**Document Hash:** 53e4d7eb217f431b4a90589a36ae1ff9
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0000000000-23-002386.hdr.sgml**: 20230605

**ACCESSION NUMBER**: 0000000000-23-002386

**CONFORMED SUBMISSION TYPE**: UPLOAD

**PUBLIC DOCUMENT COUNT**: 2

**FILED AS OF DATE**: 20230310

**FILED FOR**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Elicio Therapeutics, Inc.
- **CENTRAL INDEX KEY:** 0001601485
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **IRS NUMBER:** 113430072
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** UPLOAD

**BUSINESS ADDRESS:**
- **STREET 1:** 451 D STREET, 5TH FLOOR
- **CITY:** BOSTON
- **STATE:** MA
- **ZIP:** 02210
- **BUSINESS PHONE:** (857) 209-0050

**MAIL ADDRESS:**
- **STREET 1:** 451 D STREET, 5TH FLOOR
- **CITY:** BOSTON
- **STATE:** MA
- **ZIP:** 02210

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Angion Biomedica Corp.
- **DATE OF NAME CHANGE:** 20140228
**PUBLIC REFERENCE ACCESSION NUMBER**: 0001140361-23-006407

## Text-Extract

```

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
March       NameAngion Biomedica Corp.
       10, 2023
March2 10, 2023 Page 2
Page
FirstName LastName
         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.
Comapany
March       NameAngion Biomedica Corp.
       10, 2023
March3 10, 2023 Page 3
Page
FirstName LastName
         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
March       NameAngion Biomedica Corp.
       10, 2023
March4 10, 2023 Page 4
Page
FirstName LastName
                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.,
 Jennifer J. Rhodes, Esq.
FirstName   LastNameJennifer J. Rhodes, Esq.
Angion Biomedica    Corp.
Comapany
March       NameAngion Biomedica Corp.
       10, 2023
March5 10, 2023 Page 5
Page
FirstName LastName
         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
March       NameAngion Biomedica Corp.
       10, 2023
March6 10, 2023 Page 6
Page
FirstName LastName
         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

```

### Attached PDF Documents

**Attachment 1:** `filename1`

![img-0.jpeg](img-0.jpeg)

CORPORATION FINANCE

# UNITED STATES  
SECURITIES AND EXCHANGE COMMISSION  
WASHINGTON, D.C. 20549

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.  
Angion Biomedica Corp.  
March 10, 2023  
Page 2

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.
Angion Biomedica Corp.
March 10, 2023
Page 3

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.
Angion Biomedica Corp.
March 10, 2023
Page 4

- 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.,

Jennifer J. Rhodes, Esq.
Angion Biomedica Corp.
March 10, 2023
Page 5

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.  
Angion Biomedica Corp.  
March 10, 2023  
Page 6

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,

Division of Corporation Finance

cc: Brett D. White, Esq.