Correspondence 0001140361-23-014581 from Elicio Therapeutics, Inc. (ELTX) (CIK 0001601485) (ELTX)
Elicio Therapeutics, Inc. (ELTX) (CIK 0001601485)
Date: March 29, 2023 · CIK: 0001601485 · Accession: 0001140361-23-014581
AI Filing Summary & Sentiment
File numbers found in text: 333-269741
Referenced dates: March 10, 2023
Show Raw Text
CORRESP
1
filename1.htm
Brett D. White
T: (650) 843-5191
WhiteBD@cooley.com
March 29, 2023
U.S. Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549
Attention:
Jimmy McNamara
Tim Buchmiller
Christine Torney
Lynn Dicker
Re:
Angion Biomedica Corp.
Registration Statement on Form S-4
Filed February 13, 2023
File No. 333-269741
Ladies and Gentlemen:
We set forth below the response of Angion Biomedica Corp. (“Angion” or the “Company”) to the
comments of the staff (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) in its letter dated March
10, 2023 (the “Comment Letter”) with respect to the Company’s registration statement on Form S-4, File No. 333-269741, filed with the Commission on February 13, 2023 (the “Registration Statement”).
Angion has filed today Amendment No. 1 to the Registration Statement (“Amendment No. 1”) together with this letter via EDGAR correspondence. For the
convenience of the Staff, the numbering of the paragraphs below corresponds to the numbering of the comment in the Comment Letter, the text of which we have incorporated into this response letter in italicized type, and which is followed by the
Company’s response. Unless otherwise indicated, all page references in the responses set forth below are to the pages of Amendment No. 1. Capitalized terms not otherwise defined in this letter shall have the meanings set forth in Amendment No. 1.
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.
Response: In response to the Staff’s comment, the Company respectfully advises the Staff that the Company does not believe that the U.S. federal income tax consequences of the
Merger are material to the Company or its stockholders because the Merger is not a taxable transaction to the Company or its stockholders regardless of the U.S. federal income tax treatment of the Merger.
Whether the Merger qualifies or fails to qualify as a reorganization within the meaning of Section 368 of the Internal Revenue Code (the “Code”) does not impact
Company stockholders’ decision to approve, or not approve, the Merger, because such qualification does not have any impact on the Company or its stockholders. The Agreement and Plan of Merger and Reorganization does not contemplate existing Company
stockholders exchanging their Company shares for shares in any other entity; since Company stockholders simply retain their existing shares in the Company, there is no taxable event for them regardless of whether or not Section 368 of the Code is
applicable to other parties.
The only parties affected by the qualification of the Merger as a reorganization under Section 368 of the Code are Elicio stockholders, and the Form S-4 includes disclosure regarding the material U.S. federal income of
the Merger to them.
Cooley LLP 3175 Hanover Street Palo Alto, CA 94304-1130
t: +1 650 843 5000 f: +1 650 849 7400 cooley.com
U.S. Securities and Exchange Commission
March 29, 2023
Page Two
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, 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.
Response: In response to the Staff’s comment, the Company has revised its disclosure on pages 128 and 129 of Amendment No. 1.
Nasdaq Stock Market Listing, page 17
3.
Please disclose whether the merger is conditioned upon receiving Nasdaq listing approval to trade on 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.
Response: In response to the Staff’s comment, the Company has revised its disclosure on pages 18 and 130 of Amendment No. 1.
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.
Response: In response to the Staff’s comment, the Company has revised its disclosure on page 64 of Amendment No. 1.
Cooley LLP 3175 Hanover Street Palo Alto, CA 94304-1130
t: +1 650 843 5000 f: +1 650 849 7400 cooley.com
2
U.S. Securities and Exchange Commission
March 29, 2023
Page Three
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.
Response: In response to the Staff’s comment, the Company has revised its disclosure on page 86 of Amendment No. 1.
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 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.
Response: In response to the Staff’s comment, the Company has revised its disclosure on page 107 of Amendment No. 1.
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.
Response: In response to the Staff’s comment, the Company has revised its disclosure on pages 114 and 115 of Amendment No. 1. The number of product
candidates in the pipeline and total addressable market were not characteristics included in the selection criteria used for selecting the companies listed for comparison purposes.
Cooley LLP 3175 Hanover Street Palo Alto, CA 94304-1130
t: +1 650 843 5000 f: +1 650 849 7400 cooley.com
3
U.S. Securities and Exchange Commission
March 29, 2023
Page Four
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.
Response: In response to the Staff’s comment, the confidential materials prepared by Oppenheimer and presented to the board of directors of the
Company, have been furnished directly to the Staff by McGuireWoods LLP, as counsel to Oppenheimer, under separate cover on a confidential and supplemental basis pursuant to Rule 12b-4 under the Securities
Exchange Act of 1934, as amended (the “Rule”). In accordance with such Rule, such materials are being
provided together with a request that these materials be returned promptly following completion of the Staff’s review thereof. Such materials are not, and will not be, filed with or deemed to be part of Amendment No. 1, including any further
revisions or amendments to the Registration Statement. By separate letter, request for confidential treatment of these materials pursuant to the provisions of 17 C.F.R. §200.83 will be made by Oppenheimer.
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.
Response: In response to the Staff’s comment, the Company has revised its disclosure on page 118 of Amendment No. 1.
•
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.
Response: In response to the Staff’s comment, the Company has revised its disclosure on pages 24, 119 and 120 of Amendment No. 1.
•
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.
Response: In response to the Staff’s comment, the Company has revised its disclosure on pages 116 - 120 of Amendment No. 1.
•
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.
Response: In response to the Staff’s comment, the Company has revised its disclosure on pages 118 and 119 of Amendment No. 1.
•
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.
Response: In response to the Staff’s comment, the Company has revised its disclosure on pages 119 and 120 of Amendment No. 1.
•
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.
Response: The Company respectfully advises the Staff that the Financial Projections do not factor in any risks associated with facing competition sooner than anticipated.
Cooley LLP 3175 Hanover Street Palo Alto, CA 94304-1130
t: +1 650 843 5000 f: +1 650 849 7400 cooley.com
4
U.S. Securities and Exchange Commission
March 29, 2023
Page Five
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