Correspondence 0001493152-22-036159 from Vitro Biopharma, Inc. (VTRO) (CIK 0000793171)
Vitro Biopharma, Inc. (VTRO) (CIK 0000793171)
Date: Dec. 21, 2022 · CIK: 0000793171 · Accession: 0001493152-22-036159
AI Filing Summary & Sentiment
File numbers found in text: 000-17378
Referenced dates: November 17, 2022
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CORRESP
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filename1.htm
1401
Lawrence Street, Suite 2300, Denver, CO 80202 ● (303) 572-9300
December
21, 2022
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
Office
of Life Sciences
100
F Street, N.E.
Washington,
D.C. 20549
Re:
Vitro
Biopharma, Inc.
Amendment
No. 1 to Registration Statement on Form 10
File No.
000-17378
Filed on
November 4, 2022
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 10 (the “Registration Statement”). In connection with this letter, the Company is today filing Amendment
No. 2 to the Registration Statement (the “Amendment”) by EDGAR. 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.
Amendment
to Form 10-12G
Item
1. Business, page 5
1. Please
revise the discussion of trial results to focus on objective observations and eliminate conclusions.
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. 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.
RESPONSE:
The Company respectfully acknowledges the Staff’s comment and has revised its disclosures throughout the Amendment accordingly.
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.
Securities
and Exchange Commission
December
21, 2022
Page
2
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 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.
Our
Strategy, page 9
2. We
note your response to comment 7 and your disclosure on page 9. 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 10, 24 and 46 of the Amendment accordingly.
Preliminary
Tolerability from Foreign Clinical Studies, page 15
3. 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 15, 16, 17 and 22 in
the Amendment. The Company respectively advises the Staff that over 300 subjects have received treatment with our AlloRx Stem Cells
to date, 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.
Securities
and Exchange Commission
December
21, 2022
Page
3
Managements
Discussion and Analysis of Financial Condition and Results of Operations
Comparison
of the Years Ended October 31, 2021 and 2020
Costs
of Goods Sold, page 72
4. Please
refer to our prior comment 5. Reconcile your disclosure on page 72 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 72
5. 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 75 accordingly. Specifically,
the disclosure under Consulting Revenue for the year ended October 31, 2021 has been expanded to quantify and discuss the consulting
revenue received from Fitore for the fiscal year and the discussion under Cost of Goods Sold has been revised to clarify that the consulting
revenue in fiscal 2021 was from Fitore.
Securities
and Exchange Commission
December
21, 2022
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 74
6. Revise
to disclose what milestones were met during the period. We note your disclosure on page 23
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 nine months ended July 31,
2022 and 2021 on page 77 of the Amendment accordingly. Specifically, the Company has revised the discussion to disclose what
milestones were met during the period.
Notes
to the Consolidated Financial Statements, page F-9
7. Please
refer to our prior comment 13. 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 financial statements (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.
Note
4. Acquisitions, page F-14
8. Please
refer to our prior comment 15. 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.
Securities
and Exchange Commission
December
21, 2022
Page
5
Revenue
Recognition, page F-34
9. Revise
your revenue recognition policy here and on page 78 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 page 81, F-10 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.
In
connection with the review of its revenue recognition policy in response to this comment, the Company determined that it had improperly
recognized $200,000 of revenue during the three and nine months ended July 31, 2022. The corresponding costs which have been recorded
in selling, general and administrative expenses in the amount of $177,147 were improperly recognized during those same periods. As a
result, both the revenue and selling, general and administrative expenses have been deferred.
As
a result of the adjustments necessary to correct those errors, which materially misstated the previously issued financial statements,
the financial statements for the three and nine months ended July 31, 2022 have been restated. The restated financial statements
are included in the Amendment. Please see also Note 1 to the unaudited financial statements for the three and nine months ended July
31, 2022 and 2021, “Restatement of Previously Issued Consolidated Statements.”
* * *
The
Company requests that the Staff contact it as soon as practical with any additional comments in order that those comments can be addressed
expeditiously. 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) 256-2749 or by email at dbabiarz@polsinelli.com.
Sincerely,
/s/
David J. Babiarz
David J. Babiarz
of POLSINELLI PC
cc:
Christopher Furman,
Chief Executive Officer, Vitro Biopharma, Inc.
Nathan Haas, Chief Financial
Officer, Vitro Biopharma, Inc.
Scott A. Berdan, Shareholder,
Polsinelli PC
Tyler L. Weigel, Shareholder,
Polsinelli PC
Blank Rome LLP
Malone Bailey, LLP