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Correspondence 0001753926-22-001564 from LIPELLA PHARMACEUTICALS INC. (LIPO)

LIPELLA PHARMACEUTICALS INC.
Date: Dec. 13, 2022 · CIK: 0001347242 · Accession: 0001753926-22-001564

AI Filing Summary & Sentiment

File numbers found in text: 333-266397

Date
Dec. 13, 2022
Author
By
Form
CORRESP
Company
LIPELLA PHARMACEUTICALS INC.

Letter

Via EDGAR Division of Corporation Finance Office of Life Sciences Securities and Exchange Commission Re: Lipella Pharmaceuticals Inc. Amendment No. 3 to Registration Statement on Form S-1 Filed December 8, 2022 File No. 333-266397

Dear Sir and Madam:

This letter responds to the letter, dated December 12, 2022, received from the staff of the U.S. Securities and Exchange Commission (the “Staff”) regarding the abovementioned Amendment No. 3 to Registration Statement on Form S-1, filed on December 8, 2022 (the “Registration Statement”) by Lipella Pharmaceuticals Inc. (the “Company”, “we”, “us” or “our”). For convenience, the Staff’s comments are restated below in bold text, with each comment followed by our response. We are concurrently filing with this letter Amendment No. 4 to Registration Statement (“Amendment No. 4”). Capitalized terms used, but not defined, in this letter have the meanings ascribed to such terms in Amendment No. 4.

Amendment No. 3 to Registration Statement on Form S-1 filed December 8, 2022

Cover Page

1. We note your response to prior comment 1 and your revised disclosure where you define the “Offering” as both (emphasis added) the “initial public offering of the IPO Shares and the offering of the Stockholder Shares” and your disclosure on page 94 where you state that “[f]ollowing the expiration or termination of this Offering of the IPO Shares...,” and reissue in part. Since the term “Offering” includes “Stockholder Shares” your disclosure on page 94 remains unclear as your disclosure appears to indicate the Offering of Stockholder Shares will continue following the expiration or termination of this “Offering.” To the extent the IPO Prospectus and the Resale Prospectus have different durations of their respective offerings, please update your disclosure or defined terms or otherwise advise.

In response to the Staff’s comment, the Offering of the IPO Shares and the Offering of the Stockholder Shares may have different durations, and we have revised the cover page, the Plan of Distribution section and other disclosure throughout Amendment No. 4 in order to further clarify the durations of each such offering and to further clarify the defined terms used in Amendment No. 4.

2. Given there is no established market for your securities, please disclose the fixed price you intend to sell the Stockholder Shares listed in this prospectus. Please refer to Item 501(b)(3) of Regulation S-K and Schedule A, paragraph 16 of the Securities Act. We will not object if you disclose that the Stockholder Shares will be sold at the disclosed fixed price until your shares are listed on Nasdaq and thereafter at prevailing market prices or privately negotiated prices.

In response to the Staff’s comment, we have revised the cover page and the Plan of Distribution of Amendment No. 4 accordingly.

3. We note your cover page disclosure appears to indicate that the underwriting discounts will only apply to the “IPO Shares” when you state that the underwriting discounts are “a cash fee of 9% of the aggregate gross proceeds raised in the Offering with respect to the IPO Shares in the Offering.” However, we note your “Plan of Distribution” states “[t]he Selling Stockholders will pay all underwriting discounts and commissions and similar selling expenses, if any, attributable to the sale of the Stockholder Shares covered by this prospectus.” In addition, we note your disclosure in your “Explanatory Note” that “the Underwriting section from the IPO Prospectus will not be included in the Resale Prospectus” and the IPO Prospectus only covers the IPO Shares. To the extent, secondary shares are being sold in your IPO Prospectus please revise your Explanatory Note disclosure or otherwise advise. In addition, please file your alternative pages you identify in your Explanatory Notes.

In response to the Staff’s comment, we respectfully advise the Staff that such underwriting discounts will not apply to the Stockholder Shares. We have revised the Explanatory Note, the cover page, the Plan of Distribution and Underwriting sections, and related disclosure of Amendment No. 4 accordingly to further clarify this. The Explanatory Note provides that the preliminary prospectus included in Amendment No. 4 contains information that will be substantively identical to the information included in each of the IPO Prospectus and Resale Prospectus, and describes the most significant differences between the preliminary prospectus in Amendment No. 4 and each of the IPO Prospectus and Resale Prospectus. We have filed alternative prospective cover pages that will be included in each of the IPO Prospectus and Resale Prospectus and respectfully advise the Staff that all material information regarding the Company and such offerings has been included in Amendment No. 4, which information will not materially differ from the information to be included in each of the IPO Prospectus and the Resale Prospectus.

Recent Developments, page 4

4. We note the pro forma loss per share information for “the quarterly period” ended September 30, 2022. For clarity, please refer to this period as “the nine months ended September 30, 2022”. In addition, provide similar pro forma information for the year ended December 31, 2021.

In response to the Staff’s comment, we have revised page 4 of Amendment No. 4 accordingly.

Exhibits

5. We note that your Exhibit 5.1, legal opinion, appears to only cover the estimated proposed maximum aggregate offering price and not the specific volume of securities included on your cover page. Please revise your legal opinion to cover the specific amount of securities being registered.

In response to the Staff’s comment, we have revised Exhibit 5.1 to Amendment No. 4 accordingly.

If you have any questions or require additional information, please contact the Company’s counsel, David E. Danovitch at (212) 660-3060 or at ddanovitch@sullivanlaw.com, Benjamin Armour at (617) 338-2423 or at barmour@sullivanlaw.com, or Michael DeDonato at (212) 660-3038 or at mdedonato@sullivanlaw.com, of Sullivan & Worcester LLP.

Sincerely,
Lipella Pharmaceuticals Inc.

Show Raw Text
CORRESP
1
filename1.htm

Lipella
Pharmaceuticals Inc.

7800
Susquehanna St., Suite 505

Pittsburgh,
Pennsylvania 15208

December
13, 2022

Via
EDGAR

Jason
Drory

Anne
Parker

Division
of Corporation Finance

Office
of Life Sciences

Securities
and Exchange Commission

100
F Street, NE

Washington,
D.C. 20549

    Re:
    Lipella Pharmaceuticals Inc.

    Amendment No.
    3 to Registration Statement on Form S-1

    Filed December
    8, 2022

    File No. 333-266397

Dear
Sir and Madam:

This
letter responds to the letter, dated December 12, 2022, received from the staff of the U.S. Securities and Exchange Commission
(the “Staff”) regarding the abovementioned Amendment No. 3 to Registration Statement on Form S-1, filed on December
8, 2022 (the “Registration Statement”) by Lipella Pharmaceuticals Inc. (the “Company”, “we”,
“us” or “our”). For convenience, the Staff’s comments are restated below in bold text, with each
comment followed by our response. We are concurrently filing with this letter Amendment No. 4 to Registration Statement (“Amendment
No. 4”). Capitalized terms used, but not defined, in this letter have the meanings ascribed to such terms in Amendment No.
4.

Amendment
No. 3 to Registration Statement on Form S-1 filed December 8, 2022

Cover
Page

    1.
    We
    note your response to prior comment 1 and your revised disclosure where you define the “Offering” as both (emphasis
    added) the “initial public offering of the IPO Shares and the offering of the Stockholder Shares” and your disclosure
    on page 94 where you state that “[f]ollowing the expiration or termination of this Offering of the IPO Shares...,”
    and reissue in part. Since the term “Offering” includes “Stockholder Shares” your disclosure on page 94
    remains unclear as your disclosure appears to indicate the Offering of Stockholder Shares will continue following the expiration
    or termination of this “Offering.” To the extent the IPO Prospectus and the Resale Prospectus have different durations
    of their respective offerings, please update your disclosure or defined terms or otherwise advise.

In response to the Staff’s comment,
the Offering of the IPO Shares and the Offering of the Stockholder Shares may have different durations, and we have revised the cover
page, the Plan of Distribution section and other disclosure throughout Amendment No. 4 in order to further clarify the durations of each
such offering and to further clarify the defined terms used in Amendment No. 4.

    2.
    Given
    there is no established market for your securities, please disclose the fixed price you intend to sell the Stockholder Shares
    listed in this prospectus. Please refer to Item 501(b)(3) of Regulation S-K and Schedule A, paragraph 16 of the Securities
    Act. We will not object if you disclose that the Stockholder Shares will be sold at the disclosed fixed price until your shares
    are listed on Nasdaq and thereafter at prevailing market prices or privately negotiated prices.

In response to the Staff’s comment,
we have revised the cover page and the Plan of Distribution of Amendment No. 4 accordingly.

 3. We
                                         note your cover page disclosure appears to indicate that the underwriting discounts will
                                         only apply to the “IPO Shares” when you state that the underwriting discounts
                                         are “a cash fee of 9% of the aggregate gross proceeds raised in the Offering with
                                         respect to the IPO Shares in the Offering.” However, we note your “Plan of
                                         Distribution” states “[t]he Selling Stockholders will pay all underwriting
                                         discounts and commissions and similar selling expenses, if any, attributable to the sale
                                         of the Stockholder Shares covered by this prospectus.” In addition, we note your
                                         disclosure in your “Explanatory Note” that “the Underwriting section from
                                         the IPO Prospectus will not be included in the Resale Prospectus” and the IPO Prospectus
                                         only covers the IPO Shares. To the extent, secondary shares are being sold in your IPO
                                         Prospectus please revise your Explanatory Note disclosure or otherwise advise. In addition,
                                         please file your alternative pages you identify in your Explanatory Notes.

In response to the Staff’s comment,
we respectfully advise the Staff that such underwriting discounts will not apply to the Stockholder Shares. We have revised the Explanatory
Note, the cover page, the Plan of Distribution and Underwriting sections, and related disclosure of Amendment No. 4 accordingly to further
clarify this. The Explanatory Note provides that the preliminary prospectus included in Amendment No. 4 contains information that will
be substantively identical to the information included in each of the IPO Prospectus and Resale Prospectus, and describes the most significant
differences between the preliminary prospectus in Amendment No. 4 and each of the IPO Prospectus and Resale Prospectus. We have filed
alternative prospective cover pages that will be included in each of the IPO Prospectus and Resale Prospectus and respectfully advise
the Staff that all material information regarding the Company and such offerings has been included in Amendment No. 4, which information
will not materially differ from the information to be included in each of the IPO Prospectus and the Resale Prospectus.

Recent
Developments, page 4

 4. We
                                         note the pro forma loss per share information for “the quarterly period” ended
                                         September 30, 2022. For clarity, please refer to this period as “the nine months
                                         ended September 30, 2022”. In addition, provide similar pro forma information for
                                         the year ended December 31, 2021.

In
response to the Staff’s comment, we have revised page 4 of Amendment No. 4 accordingly.

Exhibits

 5. We
                                         note that your Exhibit 5.1, legal opinion, appears to only cover the estimated proposed
                                         maximum aggregate offering price and not the specific volume of securities included on
                                         your cover page. Please revise your legal opinion to cover the specific amount of securities
                                         being registered.

In
response to the Staff’s comment, we have revised Exhibit 5.1 to Amendment No. 4 accordingly.

If
you have any questions or require additional information, please contact the Company’s counsel, David E. Danovitch at (212)
660-3060 or at ddanovitch@sullivanlaw.com, Benjamin Armour at (617) 338-2423 or at barmour@sullivanlaw.com, or Michael DeDonato
at (212) 660-3038 or at mdedonato@sullivanlaw.com, of Sullivan & Worcester LLP.

    Sincerely,

    Lipella Pharmaceuticals Inc.

    By:
    /s/
    Jonathan Kaufman

    Name: Jonathan Kaufman

    Title: Chief Executive Officer

    cc:
    David
    E. Danovitch, Esq., Sullivan & Worcester LLP

    Benjamin Armour,
    Esq., Sullivan & Worcester LLP

    Michael DeDonato,
    Esq., Sullivan & Worcester LLP