Correspondence 0001493152-23-015831 from Vitro Biopharma, Inc. (VTRO) (CIK 0000793171)
Vitro Biopharma, Inc. (VTRO) (CIK 0000793171)
Date: May 8, 2023 · CIK: 0000793171 · Accession: 0001493152-23-015831
AI Filing Summary & Sentiment
File numbers found in text: 333-267366
Referenced dates: November 17, 2022
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CORRESP
1
filename1.htm
1401
Lawrence Street, Suite 2300, Denver, CO 80202 ● (303) 572-9300
May
8, 2023
David
J. Babiarz
(303)
256-2749
(720)
228-2296 Fax
dbabiarz@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. 1 to Registration Statement on Form S-1
Filed on
November 3, 2022
File No.
333-267366
Ladies
and Gentlemen:
On
behalf of our client, Vitro Biopharma, Inc. (the “Company”), set forth below are responses to the comments of the
Staff of the Division of Corporation Finance (the “Staff”) 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 Amendment No. 2 to the Registration Statement (the “Amendment”) by EDGAR. Please note that the Amendment includes
(1) audited consolidated financial statements for the fiscal years ended October 31, 2022 and 2021; and (2) interim consolidated financial
statements as of January 31, 2023 and 2022 and for the periods then-ended. The Amendment also includes the changes necessary to conform,
as applicable, the disclosure in the Amendment to the changes made by the Company in response to the Staff’s comments to the Company’s
Registration Statement on Form 10 (the “Form 10”), for which the Staff completed its review on January 25, 2023 and had no
further comments to such Form 10.
For
your convenience, each of the Staff’s comments included in its letter dated November 17, 2022 is reprinted below in italics, and
is followed by the Company’s response.
polsinelli.com
Atlanta
Boston
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Phoenix
St. Louis
San Francisco
Seattle
Silicon
Valley
Washington, D.C.
Wilmington
Polsinelli
PC, Polsinelli LLP in California
Securities
and Exchange Commission
May
8, 2023
Page
2
Amendment
No. 1 to Form S-1 filed November 3, 2022
Cover
Page
1. Please
revise your cover page to indicate whether your offering is contingent on final approval
of your listing on NYSE American.
RESPONSE:
The Company respectfully acknowledges the Staff’s comment and has revised the cover page of the Amendment to disclose that completion
of the offering is contingent upon the successful listing of our common stock on the NYSE American.
Summary,
page 1
2. Please
revise your summary to focus on your product candidates and your operations. Please move
the discussion of studies conducted by other parties to the Business section. To the extent
that you have included comparisons to other products, please confirm that the cited studies
included head to head comparisons. If they did not, then remove any discussions comparing
your product candidates to other products or product candidates. The descriptions of trial
results should be limited to objective observations. For example, rather than indicating
that the UC-derived MSCs exhibited the highest proliferation rate and higher concentrations
of immunomodulatory substances, disclose the observed rates and concentrations for UC-derived
MSCs, AD-MSCs and PL-MSCs; and rather than indicating that you observed the highest IDO activity
in UC-derived MCSs as compared to the other MSCs explain how you measured such activity and
objectively describe your observations.
RESPONSE:
The Company respectfully acknowledges the Staff’s comment and has revised its disclosures throughout the Amendment accordingly,
including to move the discussion of studies conducted by other parties to the Business section. In addition to focusing its discussion
of pre-clinical study results on objective observations, the Company has supplemented certain of its disclosures in the Amendment to
include additional context and explanatory language to enhance readability and investor comprehension, balancing the importance of plain
English principles with the inherent complexities of biotechnology and the technical nature of objective data derived from pre-clinical
studies.
The
Company also confirms that its extensive pre-clinical studies described throughout the Amendment analyzed certain biological characteristics
of AlloRx Stem Cells, which are mesenchymal stem cells (“MSCs”) sourced from the Wharton’s jelly of umbilical cords,
in head-to-head comparisons to MSCs sourced from other starting raw material sources, including MSCs derived from bone-marrow, adipose/fat
and placenta. In addition to including a discussion of the Company’s pre-clinical study results using AlloRx Stem Cells, the Business
section of the Amendment also includes select discussions of pre-clinical studies conducted by third parties that also analyze MSCs sourced
from the Wharton’s jelly of umbilical cords in head-to-head comparisons to MSCs sourced from other starting raw material sources.
We believe our extensive pre-clinical studies using AlloRx Stem Cells, including those described in the Amendment, support our belief
that AlloRx Stem Cells, along with other similar MSCs derived from the Wharton’s jelly of umbilical cords, may have advantages
compared to other MSCs derived from other starting raw material sources, including MSCs derived from bone-marrow, adipose/fat and placenta.
Securities
and Exchange Commission
May
8, 2023
Page
3
Management’s
Discussion and Analysis of Financial Condition and Results of Operations Comparison of the Years Ended October 31, 2021 and 2020
Cost of Goods Sold, page 55
3. Please
refer to our prior comment 7. Reconcile your disclosure on page 55 that indicates that the
inventory write-off is due to the fact that you were not able to complete an inventory with
your disclosure on page F-13 that indicates that you periodically review the value of items
in inventory and provide write-downs or write-offs of inventory based on your assessment
of market conditions. Further, explain why the inability to complete a physical count of
inventory resulted in a write-off of inventory and how you were able to determine the amount
of the inventory write-off.
RESPONSE:
The Company respectfully acknowledges the Staff’s comment. The Company hereby confirms as accurate its stated policy of periodically
reviewing the value of items in inventory and providing write-downs or write-offs based on the assessment of market conditions. Despite
this policy, the audit of the Company’s financial statements for the year ended October 31, 2020 commenced months after the end
of the fiscal year, sometime during fiscal 2021. The write-off for that year was due to the Company’s determination that it could
only support the carrying value of $35,000 of inventory that existed as of October 31, 2020, as a result of a physical inventory count
that occurred subsequent to October 31, 2020 and available accounting records and personnel constraints. For all periods subsequent to
fiscal 2020, the Company confirms that it has followed that policy.
The
value of the inventory written off was derived from the historical costs recorded in the general ledger.
Consulting
Revenue, page 55
4. Your
disclosure indicates that your Consulting Revenue is related to your European Wellness contract
and you recognized $0 in consulting revenue in fiscal 2021. Your discussion of the increase
in Costs of Goods Sold that follows attributes the increase to consulting revenue recorded
in 2021. Please revise your disclosure to address this apparent inconsistency and to also
quantify and discuss the consulting revenue related to Fitore.
RESPONSE:
The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on page 68 accordingly. Specifically,
the disclosure under Consulting Revenue for the fiscal years ended October 31, 2022 and 2021 has been expanded to quantify and discuss
the consulting revenue received from Fitore for fiscal year 2021. As disclosed in the Amendment, no Fitore consulting revenue was recorded
during 2022.
Securities
and Exchange Commission
May
8, 2023
Page
4
Comparison
of the Three and Nine Months Ended July 31 2022 to the Three and Nine Months Ended July 31, 2021
Consulting
Revenue, page 56
5. Revise
to disclose what milestones were met during the period. We note your disclosure on page 82
that you are currently in the early stage of identification and potential development of
any key investigational product candidate.
RESPONSE:
The Company respectfully acknowledges the Staff’s comment and has revised the MD&A section for the fiscal years ended October
31, 2022 and 2021 on page 68 of the Amendment accordingly. Specifically, the Company has revised the discussion to disclose what
milestones were met during fiscal year 2022, namely the (1) development and deployment of a quality management system for European Wellness,
and (2) delivery of a manual for the aforementioned system in order to position European Wellness for FDA authorization as a U.S.-based
cGMP manufacturer for products being studied for potential IND authorization.
Our
Strategy, page 66
6. We
note your response to comment 10 and your disclosure on page 67. Despite your references
to “collaborative relationships” the expected agreements appear to be limited
to service agreements for the performance of clinical trails [sic] and supply agreements.
Please revise to clarify that these relationships do not involve the types of arrangements
whereby you would share the risks and rewards with a collaborative partner. Alternatively,
revise the disclosure to clarify the types of collaborative arrangements you expect to enter
into, including a discussion of the role a collaborative partner may take in the development
of your product candidates.
RESPONSE:
The Company respectfully acknowledges the Staff’s comment and has revised pages 21, 83 and 101 of the Amendment accordingly.
Preliminary
Tolerability from Foreign Clinical Studies, page 73
7. We
note your disclosure that you receive data related to the occurrence of serious adverse events.
To the extent that there have been any serious adverse events related to treatment with AlloRx
Stem Cells, please describe the events and disclose the number of incidents.
RESPONSE:
The Company respectfully acknowledges the Staff’s comment and directs the Staff to disclosures
on pages 91, 92, 93 and 99 in the Amendment. The Company respectively advises the Staff that over 348 subjects have
received treatment with our AlloRx Stem Cells, primarily in foreign clinical studies conducted by third parties, and no serious adverse
events have been reported that were considered related to the product candidate.
Notes
to the Consolidated Financial Statements, page F-9
8. Please
refer to our prior comment 16. In light of the significance of your research and development
contract with European Wellness, revise to include a separate footnote to discuss the significant
terms of the contract including what your obligations are under the contract, what payments
you have received under the contract, what milestones you have reached, future milestones
and payments, how you classify expenses incurred under the contract, termination rights,
etc.
RESPONSE:
The Company respectfully acknowledges the Staff’s comment and has revised the Notes accordingly. Specifically, the Company has
included a separate footnote in the audited consolidated financial statements for the fiscal years ended October 31, 2022 and 2021 (Note
1- Joint Operating Agreement) to discuss the significant terms of the European Wellness contract, including the Company’s obligations,
what payments have been received, the associated milestones, future milestones, termination rights and how expenses associated with the
contract are classified.
Securities
and Exchange Commission
May
8, 2023
Page
5
Note
4. Acquisitions, page F-14
9. Please
refer to our prior comment 18. Please tell us how you considered whether to reflect the termination
of the Fitore business in your pro forma income statement on page F-2, citing the applicable
guidance on which you relied.
RESPONSE:
The Company respectfully acknowledges the Staff’s comment. However, the Company does not believe that the termination of the chief
executive officer and employees of Fitore indicates that the sales and operations of Fitore will be discontinued. On the contrary, the
sales, marketing and operations of Fitore will continue through the efforts of employees of the consolidated Company.
Further,
the termination of Fitore, even if it had occurred, would not have a major effect on the Company’s operations; it is an insignificant
part of the Company’s operations and revenue.
Revenue
Recognition, page F-34
10. Revise
your revenue recognition policy here and on page 61 to include your revenue recognition policy
regarding milestone payments under your long term contract, including at what point the related
revenue is recognized.
RESPONSE:
The Company respectfully acknowledges the Staff’s comment and has revised the MD&A and Notes accordingly. Specifically, the
Revenue Recognition policy on pages F-8 and F-35 has been revised to include the Company’s policy regarding
milestone payments under its long term contract with European Wellness, including at what point the related revenue is recognized.
*
* *
Securities
and Exchange Commission
May
8, 2023
Page
6
The
Company requests that the Staf