SEC Comment Letter 0000000000-23-002386 to Elicio Therapeutics, Inc. (ELTX) (CIK 0001601485) (ELTX)
Elicio Therapeutics, Inc. (ELTX) (CIK 0001601485)
Date: March 10, 2023 · CIK: 0001601485 · Accession: 0000000000-23-002386
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File numbers found in text: 333-269741
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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,
FirstName LastNameJennifer J. Rhodes, Esq.
Comapany NameAngion Biomedica Corp.
March 10, 2023 Page 2
FirstName LastNameJennifer 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
FirstName LastNameJennifer J. Rhodes, Esq.
Comapany NameAngion Biomedica Corp.
March 10, 2023 Page 3
FirstName LastNameJennifer 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.
FirstName LastNameJennifer J. Rhodes, Esq.
Comapany NameAngion Biomedica Corp.
March 10, 2023 Page 4
FirstName LastNameJennifer 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.,
FirstName LastNameJennifer J. Rhodes, Esq.
Comapany NameAngion Biomedica Corp.
March 10, 2023 Page 5
FirstName LastNameJennifer 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
FirstName LastNameJennifer J. Rhodes, Esq.
Comapany NameAngion Biomedica Corp.
March 10, 2023 Page 6
FirstName LastNameJennifer 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 port