Correspondence 0001493152-23-020021 from Vitro Biopharma, Inc. (VTRO) (CIK 0000793171)
Vitro Biopharma, Inc. (VTRO) (CIK 0000793171)
Date: June 2, 2023 · CIK: 0000793171 · Accession: 0001493152-23-020021
AI Filing Summary & Sentiment
File numbers found in text: 333-267366
Referenced dates: May 26, 2023
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CORRESP
1
filename1.htm
1401
Lawrence Street, Suite 2300, Denver, CO 80202 • (303) 572-9300
June
2, 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. 2 to Registration Statement on Form S-1
Filed
on May 8, 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. 3 to the Registration Statement (the “Amendment”) by EDGAR.
For
your convenience, each of the Staff’s comments included in its letter dated May 26, 2023 is reprinted below in italics, and is
followed by the Company’s response.
Amendment
No. 2 to Registration Statement on Form S-1, filed May 8, 2023
Summary,
page 1
1. Please
include higher resolution images of each of the charts presented on pages 2, 3, 97 and 98.
Currently the tables are difficult to read.
RESPONSE:
The Company has complied with this Staff comment by including the requested higher resolution images of each of the charts referenced
in the Staff comment.
Securities
and Exchange Commission
June
2, 2023
Page
2
Management’s
Discussion and Analysis of Financial Condition and Results of Operations
Critical
Accounting Estimates, page 75
2. We
note your disclosure stating that you have determined that you have no critical accounting
estimates material to your consolidated financial position, results of operations, or cash
flow related to your consolidated financial statements included in this prospectus. Please
tell us how you determined that the estimates you used in evaluating goodwill and other intangible
assets for impairment and the estimates you used in valuing your stock-based compensation
are not material to your financial statements.
RESPONSE:
The Company respectfully advises the Staff that it, after consultation with its independent registered public accounting firm, continues
to believe that it has a reasonable basis to determine that disclosure concerning the estimates it used in evaluating goodwill and other
intangible assets for impairment and the estimates it used in valuing its stock-based compensation is not material to an investor’s
ability to understand in all material respects the Company’s consolidated financial statements. Nevertheless, the Company has complied
with this Staff comment by replacing at the Staff’s suggestion the statement identified above with more fulsome disclosure on page
76 of the Amendment concerning the applicable critical accounting estimates used by the Company in evaluating goodwill and other intangible
assets for impairment and the estimates it used in valuing its stock-based compensation.
Our
Products
Cosmetic
Conditioned Media and Exosome-Containing Serums, page 90
3. We
note your disclosure that from June 2022 to July 2022, you “voluntarily suspended sales
of InfiniVive MD’s Exosome Serum in the United States in order to conduct an investigation
into the administration of this product by medical professionals that have purchased this
product directly from [you] or via distribution from other medical professionals.”
Please revise your disclosure to provide further details about what prompted your decision
to voluntarily suspend sales of this product, what the basis of your investigation was, what,
if anything, your investigation uncovered and which regulatory advisors you consulted with.
RESPONSE:
The Company supplementally and respectfully advises the Staff that it obtained anecdotal information from industry participants about
the potential improper administration by medical professionals of other producers’ exosome serums, and the Company had been contacted
on more than one occasion to ask whether the Company’s product could be used other than topically. It was when this information
was reported by management to the Company’s Board of Directors that prompted the investigation. As described in the Amendment,
InfiniVive MD’s Exosome Serum is marketed and sold by the Company in the United States exclusively to certified plastic surgeons,
cosmetic surgeons, aestheticians and other medical professionals and solely for topical use. As a result of the foregoing and out of
an abundance of caution, it was determined to be most prudent to suspend sales of the product during the investigation to ensure that
the Company’s medical professional customers were using the Company’s products only topically as directed and otherwise in
compliance with the Company’s use restrictions and applicable laws and regulations and to limit potential exposure to legal liability
and regulatory enforcement if the customers were misusing the product. Upon completion of the investigation, it was determined that the
Company’s products were not being misused or misapplied and, following discussion with the Company’s legal advisors specializing
in regulations relevant to the sale of the Company’s products, the Company resumed sales. During the investigation, the Company
also reviewed and further enhanced its permitted use labeling and also determined 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 the Company’s instructions, as further described in the labeling. Because the voluntarily suspension of sales
of InfiniVive MD’s Exosome Serum in the United States lasted only a few weeks and, in hindsight, did not have a material impact
on the Company’s operating results or financial condition, the Company has determined that the disclosure is no longer relevant
to making an investment decision and could be considered misleading to investors if retained or expanded in the prospectus – perpetuating
a discussion about immaterial and ultimately irrelevant information could confuse investors. Therefore, the Company respectfully has
deleted the discussion from the prospectus in response to this Staff comment.
Securities
and Exchange Commission
June
2, 2023
Page
3
Preliminary
Tolerability Data from Foreign Clinical Studies, page 92
4. We
note your disclosure here that you receive “data relating to any occurrence of any
serious adverse events[.]” Please clarify your disclosure here to note whether any
serious adverse events have actually been recorded and whether you have received such data
from any foreign third-party clinics using AlloRx Stem Cells. To the extent you have received
reports of serious adverse events, describe the events and quantify the number of each type
of event.
RESPONSE:
The Company respectfully advises the Staff that, as disclosed in the Amendment, over 348 human subjects have received treatment with
the Company’s AlloRx Stem Cells, primarily in foreign clinical studies conducted by third parties, and zero serious adverse events
have been reported that were considered related to the product candidate. The Company respectfully directs the Staff to the following
disclosures on page 92 of the Amendment (emphasis added):
“As
of March 15, 2023, over 348 subjects have received treatment with AlloRx Stem Cells via peripheral intravenous infusion or direct injection
for potential treatment of a wide variety of indications, including ARDS due to COVID-19, Long COVID, MS, ALS, Lupus, MSA, Alzheimer’s
disease, CKD, COPD, diabetes and age-related conditions. To
date, there have been no serious adverse events reported that were considered related to AlloRx Stem Cells.”
In
addition, the Company respectfully directs the Staff to similar disclosures on pages 93, 94 and 100 of the Amendment, which also disclose
that there have been no serious adverse events reported to date that were considered related to the product candidate. The Company respectfully
believes, therefore, that no further disclosure should be necessary in response to this Staff comment.
Financial
Statements for Fiscal Years Ended October 31, 2022 and 2021
Note
5- Intangible Assets, page F-17
5. Please
expand your note disclosure of intangible assets subject to amortization to include the estimated
aggregate amortization expense for each of the five succeeding fiscal years, in accordance
with ASC 350-30-50-2(a)(3).
RESPONSE:
The Company has complied with this Staff comment by revising Note 5—Intangible Assets on pages F-17 and F-40 of the Amendment to
present the Company’s anticipated aggregate future amortization expense related to its intangible assets for each of the succeeding
five fiscal years ending October 31, 2027.
*
* *
Securities
and Exchange Commission
June
2, 2023
Page
4
The
Company requests that the Staff contact it as soon as practicable with any additional comments it may have in order that those comments
can expeditiously be addressed. If you have any questions or would like further information with regard to the foregoing, please do not
hesitate to contact the undersigned by phone at (303) 583-8235 or by email at sberdan@polsinelli.com.
Sincerely,
/s/
Scott A. Berdan
Scott
A. Berdan
of
POLSINELLI PC
cc:
Christopher
Furman, Chief Executive Officer, Vitro Biopharma, Inc.
Nathan
Haas, Chief Financial Officer, Vitro Biopharma, Inc.
Tyler
L. Weigel, Shareholder, Polsinelli PC
Blank
Rome LLP
Malone
Bailey, LLP