Correspondence 0001493152-23-022975 from Vitro Biopharma, Inc. (VTRO) (CIK 0000793171)
Vitro Biopharma, Inc. (VTRO) (CIK 0000793171)
Date: June 29, 2023 · CIK: 0000793171 · Accession: 0001493152-23-022975
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File numbers found in text: 333-267366
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CORRESP
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filename1.htm
1401
Lawrence Street, Suite 2300, Denver, CO 80202 ● (303) 572-9300
*FOIA
Confidential Treatment Request*
Confidential
Treatment Requested by Vitro Biopharma, Inc.
June
29, 2023
Scott
A. Berdan
(303)
583-8235
sberdan@polsinelli.com
VIA
EDGAR
Mr.
Joshua Gorsky
Ms.
Suzanne Hayes
Ms.
Julie Sherman
Mr.
Kevin Vaughn
United
States Securities and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
D.C. 20549
Re: Vitro
Biopharma, Inc.
Amendment
No. 3 to Registration Statement on Form S-1
Filed
on June 2, 2023
File
No. 333-267366
Ladies
and Gentlemen:
On
behalf of our client, Vitro Biopharma, Inc., a Nevada corporation (the “Company”), set forth below are responses to
the comments of the Staff of the Division of Corporation Finance (the “Staff”) of the Securities and Exchange Commission
(the “Commission”) regarding the above-captioned amendment to the registration statement on Form S-1 (as amended,
the “Registration Statement”). In connection with this letter, the Company is today filing with the Commission Amendment
No. 4 to the Registration Statement (the “Amendment”) by EDGAR. In addition to the changes made in response to the
Staff’s comments on the Registration Statement as discussed further below, the Amendment also includes, as a result of the passage
of time, interim consolidated financial statements as of April 30, 2023 and 2022 and for the relevant three- and six-month periods then
ended.
The
Company further advises the Staff that it and the underwriter have determined an estimated share price range for the proposed offering,
as reflected in the Amendment. As a result, the Company can now respond to the Staff’s Comment 9 from its letter to the Company
dated October 6, 2022 (the “Original Comment Letter”) concerning the filing of the initial registration statement
on Form S-1 (File No. 333-267366) with respect to which the Amendment relates (the “Initial Registration Statement”).
polsinelli.com
Atlanta Boston Chicago Dallas Denver Houston Kansas
City Los
Angeles Miami Nashville New York
Phoenix St. Louis San
Francisco Seattle SiliconValley Washington,
D.C. Wilmington
Polsinelli
PC, Polsinelli LLP in California
Securities
and Exchange Commission
June
29, 2023
Page
2
*FOIA
Confidential Treatment Request*
Confidential
Treatment Requested by Vitro Biopharma, Inc.
in
connection with Registration Statement on Form S-1 (File No. 333-267366)
Due
to the commercially sensitive nature of information contained in this letter, this submission is accompanied by the Company’s request
for confidential treatment for selected portions of this letter. The Company has filed a separate letter with the Office of Freedom of
Information and Privacy Act Operations in connection with the confidential treatment request pursuant to Rule 83 of the Commission’s
Rules on Information and Requests (17 C.F.R. § 200.83). For the Staff’s reference, we have enclosed a copy of the Company’s
letter to the Office of Freedom of Information and Privacy Act Operations as well as a copy of this letter, marked to show the portions
redacted from the version filed via EDGAR and for which the Company is requesting confidential treatment.
For
your convenience, each of the Staff’s outstanding comments included in its Original Comment Letter and the letter to the Company
regarding the Amendment dated June 12, 2023 is reprinted below in italics (in each case below an appropriate bold and underlined letter
identifying caption), and is followed by the Company’s response.
Registration
Statement
Cosmetic
Conditioned Media and Exosome-Containing Serums, page 91
1. We
note your response to prior comment 3. Please revise your registration statement to include
the disclosure that was deleted regarding the investigation of the administration of InfiniVive
MD’s Exosome Serum by medical professionals that have purchased this product directly
from you or via distribution from other medical professionals, the origin and purpose of
the investigation, your decision to voluntarily suspend sales of the product from June 2022
to July 2022 and, as you note in your response, the results of the investigation and the
actions you took in response to the investigation (i.e., the enhancements that were made
to the permitted use labeling of the product and your decision to require all customers to
complete a written certification confirming, prior to shipment of the product, that the product
would be administered by the customers only in accordance with the product’s permitted
uses and your instructions).
Additionally,
please revise your risk factor disclosure to describe the risks associated with the off-label use of exosome serums specifically.
RESPONSE:
The Company has complied with this Staff comment by revising its disclosure on pages 93 and 43 of the Amendment, including its risks
factors. In addition, the Company respectfully directs the Staff to other relevant disclosures regarding potential off-label use of the
Company’s products that are already included in the Amendment, including the risk factor on page 37 of the Amendment under the
caption “The FDA and other regulatory agencies
actively enforce the laws and regulations prohibiting the promotion of off-label uses” and related
disclosures on pages 118 and 119 in the Business section under the captions “U.S. Biologic Drug Development Process—Post-Approval
Requirements” and “—U.S. Regulation of Wellness Products.”
Securities
and Exchange Commission
June
29, 2023
Page
3
*FOIA
Confidential Treatment Request*
Confidential
Treatment Requested by Vitro Biopharma, Inc.
in
connection with Registration Statement on Form S-1 (File No. 333-267366)
Initial
Registration Statement
Critical
Accounting Estimates
Equity-Based
Compensation
9. Once
you have an estimated offering price or range, please explain to us how you determined the
fair value of the common stock underlying your equity issuances and the reasons for any differences
between the recent valuations of your common stock leading up to the initial public offering
and the estimated offering price. This information will help facilitate our review of your
accounting for equity issuances including stock compensation and beneficial conversion features.
Please discuss with the staff how to submit your response.
RESPONSE:
The Company respectfully submits the below additional information to assist the Staff in its review of the Company’s position with
respect to its determination of the fair value of the Company’s common stock (“common stock”) underlying its
equity issuances and the reasons for any differences between the recent valuations of its common stock leading up to its public offering
of common stock (the “public offering”) and the estimated offering price. As further described in the analysis that
follows, the Company respectfully advises the Staff that:
● The
Company currently expects a price range of approximately $5.00 to $6.00 per share (the “Preliminary
Price Range”) for its public offering of common stock;
● The
Company’s analysis prior to the public offering indicated the fair value of the Company’s
common stock to be $[****] per share, which was the fair value the Company used for
all of its equity issuances since February 22, 2022, including the stock options granted
by the Company on March 1, 2022 and July 6, 2022; and
● The
Company has not granted any stock options or other equity awards since July 6, 2022.
All
share numbers and per share prices set forth herein reflect the impact of a 1-for-26 reverse stock split of the common stock that the
Company anticipates will be effected prior to the effectiveness of the Registration Statement (the “Reverse Stock Split”),
as further described in the Amendment. Accordingly, all share numbers and per share prices, including the Preliminary Price Range, set
forth herein are presented on a post-Reverse Stock Split basis, unless otherwise indicated.
CERTAIN
CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETED ASTERISKS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
COMMISSION PURSUANT TO 17 C.F.R. §200.83
Securities
and Exchange Commission
June
29, 2023
Page
4
*FOIA
Confidential Treatment Request*
Confidential
Treatment Requested by Vitro Biopharma, Inc.
in
connection with Registration Statement on Form S-1 (File No. 333-267366)
Stock
Option Awards Granted Since November 1, 2021
The
Company granted the following option awards since November 1, 2021, all of which were granted in the Company’s fiscal year ended
October 31, 2022:
Date of Grant
Number of Shares
Subject to Options
Granted
Exercise Price
Per Share
Estimated Fair
Value Per
Share at
Grant Date
March 1, 2022
13,460
$ 26.00
$ [**** ]
July 6, 2022
192,307
$ 26.00
$ [**** ]
As
set forth in the table above, the Company granted: (i) an aggregate of 13,460 stock options on March 1, 2022, 6,730 of which were granted
to an employee and 6,730 of which were granted to a consultant of the Company; and (ii) 192,307 stock options on July 6, 2022, all of
which were granted to Christopher Furman in connection with his appointment as Chief Executive Officer of the Company. The Company does
not intend to grant to employees, directors or consultants any options or other equity awards prior to the public offering.
Accounting
for Stock-Based Grants
As
further described in the Amendment, the Company accounts for grants of stock options to employees and non-employees based on the options’
grant date fair value and the Company recognizes compensation expense over the vesting periods. The Company estimates the fair value
of stock options as of the date of grant using the Black-Scholes option pricing model. See the discussion on page 78 of the Amendment
under the caption “Management’s Discussion and Analysis of Financial Condition and Results of Operation—Critical
Accounting Estimates—Stock-Based Compensation Expense.”
Determining
the Fair Value of Common Stock Prior to the Public Offering
For
an explanation of how the Company determined the fair value of the common stock underlying its equity issuances prior to the public offering,
the Company respectfully refers the Staff to the discussion of its general approach set forth on page 78 of the Amendment under the
caption “—Estimating the Fair Value of Common Stock.”
CERTAIN
CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETED ASTERISKS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
COMMISSION PURSUANT TO 17 C.F.R. §200.83
Securities
and Exchange Commission
June
29, 2023
Page
5
*FOIA
Confidential Treatment Request*
Confidential
Treatment Requested by Vitro Biopharma, Inc.
in
connection with Registration Statement on Form S-1 (File No. 333-267366)
When
performing the fair value calculations using the Black-Scholes option pricing model, the Company is required to estimate the fair value
of its common stock underlying its stock-based awards, which is the most subjective input into the Black-Scholes option pricing model.
Because there has been no public market for the common stock during the period discussed herein, the fair value of the common stock underlying
stock options has been determined on each grant date by the Company’s board of directors (the “Board”), with
input from management, primarily by referencing arms-length transactions inclusive of the common stock underlying such transactions which
occurred on or near the valuation date(s). In addition to an evaluation of arms-length transactions involving our common stock, the Board
considered various objective and subjective factors to estimate the estimated fair value of the common stock, including:
● the
estimated value of the Company’s securities both outstanding and anticipated;
● the
anticipated capital structure, which will directly impact the value of the currently outstanding
securities;
● the
Company’s results of operations and financial position;
● the
status of the Company’s research and development efforts;
● the
lack of liquidity of the Company’s common stock as a private company;
● the
Company’s stage of development and business strategy and the material risks related
to our business and industry;
● external
market conditions affecting the life sciences and biotechnology industry sectors;
● U.S.
and global economic conditions;
● the
likelihood of achieving a liquidity event for the holders of common stock, such as a public
offering or a sale of the Company, given prevailing market conditions; and
● the
market value of comparable companies.
Background
– Issuance of 2021 Convertible Note with Embedded Conversion Price
On
October 12, 2021, the Company borrowed $3,000,000 in connection with a Senior Secured Convertible Promissory Note (the “Convertible
Note”) issued to a third-party, accredited investor in an arms-length transaction. The Convertible Note was set to mature on
October 12, 2026 and bore interest at a rate of 5% per annum. The Convertible Note was secured by all the assets of the Company and was
eligible to be prepaid in whole or in part at any time prior to maturity. In addition, the Convertible Note was convertible at the option
of the holder together with accrued and unpaid interest at $26.00 per share (or $1.00 per share on a pre-Reverse Stock Split basis).
On
February 22, 2022, the Convertible Note, along with accrued and unpaid interest of $17,158 and $695,342 in unearned and unpaid interest
through the term of the Convertible Note, was voluntarily converted at the option of the holder into 142,788 shares of the common stock
at $26.00 per sh