SEC Company Response from Vicapsys Life Sciences, Inc. (VICP) (CIK 0001468639) (VICP) — Mar 20, 2020
Vicapsys Life Sciences, Inc. (VICP) (CIK 0001468639)
Date: March 20, 2020 · CIK: 0001468639 · Accession: 0001493152-20-004429
AI Filing Summary & Sentiment
File numbers found in text: 000-56145
Referenced dates: March 10, 2020
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CORRESP
1
filename1.htm
ANTHONY
L.G., PLLC
laura
aNTHONy, esq
GEOFFREY
ASHBURNE, ESQ*
JOHN
CACOMANOLIS, ESQ**
CHAD
FRIEND, ESQ, LLM
SVETLANA
ROVENSKAYA, ESQ***
OF
COUNSEL:
MICHAEL
R. GEROE, ESQ, CIPP/US****
CRAIG
D. LINDER, ESQ*****
PETER
P. LINDLEY, ESQ, CPA, MBA
Philip
magri, esq.******
STUART
REED, ESQ
MARC
S. WOOLF, ESQ
www.ANTHONYPLLC.com
WWW.SECURITIESLAWBLOG.COM
WWW.LAWCAST.COM
DIRECT
E-MAIL: PMagri@ANTHONYPLLC.COM
*licensed
in CA
**licensed
in FL and NY
***licensed
in NY and NJ
****licensed
in CA, DC, MO and NY
*****licensed
in CA, FL and NY
******licensed
in FL and NY
March
20, 2020
VIA
ELECTRONIC EDGAR FILING
Office
of Life Sciences
Division
of Corporate Finance
Securities
and Exchange Commission
100
F. Street, N.E.
Washington,
D.C. 20549
Re:
Vicapsys
Life Sciences Inc.
Registration
Statement on Form 10-12G
Filed
on February 12, 2020
File
No. 000-56145
Dear
Sir or Madam:
We
have electronically filed herewith on behalf of Vicapsys Life Sciences, Inc. (the “Company”) Amendment No.
1 (“Amendment No. 1”) to the above-referenced Registration Statement on Form 10 originally filed on February
12, 2020 (“Form 10”).
In
addition, we have included a narrative response herein keyed to the comments of the staff of the Division of Corporation
Finance (the “Staff”) set forth in the Staff’s comment letter, dated March 10, 2020, to the Company
regarding the Form 10. For the Staff’s convenience, the Staff’s comments have been stated below in their entirety
in italics, followed by the corresponding responses from the Company. Except for any page references appearing in the
headings or the Staff’s comments (which are references to the Form 10 submitted on February 12, 2020, all page
references herein correspond to the page of Amendment No. 1. Capitalized terms used but not defined in this letter have the
meanings ascribed to such terms in Amendment No. 1.
625
N. FLAGLER DRIVE, SUITE 600 ● WEST PALM BEACH, FLORIDA ● 33401 ● PHONE: 561-514-0936 ● FAX 561-514-0832
Division
of Corporate Finance
U.S.
Securities and Exchange Commission
March
20, 2020
Page
2
Business
Overview, page 5
1. Please
revise your references to “encapsulated products,” “VICAPSYN,”
“lead product” and “proprietary
product line” to clarify you are referring to product candidates since it appears
you do not currently have any approved products.
RESPONSE:
In response to the Staff’s comment, we have revised references to “encapsulated products,” “VICAPSYN,”
“lead product” and “proprietary product line” on page 5 to
clarify that we are referring to product candidates.
MGH
License Agreement, page 6
2. We
note that you state that the MGH License Agreement permits you to engage in certain
activities with respect to the Products, Processes, Materials, and Technological
Information. Please revise your discussion to explain what these items entail rather
than referencing the defined terms in the MGH License Agreement.
RESPONSE:
In response to the Staff’s comment, have revised our discussion of the MGH License Agreement on page 6 to explain
what is entailed with respect to Products, Processes, Materials, and Technological Information rather than referencing the defined
terms in the MGH License Agreement.
3. You
state that under the MGH License Agreement the company must satisfy certain requirements
before the sale of certain products. You also state that the requirements must be satisfied
by certain dates that have already passed and that such dates are currently subject to
negotiations. Please clarify any progress you have made with respect
to each of these requirements. For example, have you performed any research related
to the role of CXCL12? Additionally, expand your disclosure to discuss in more detail
the status of such negotiations.
RESPONSE:
Per the Staff’s comment, we have revised the disclosure on page 6 to explain the progress that the Company was required
to make with respect to certain requirements that the Company must satisfy before the sale of certain products as well as the
progress of the Company’s negotiations for extending deadlines which have passed.
Competition,
page 10
4. Please
expand the discussion of your competitors developing therapies to treat Type 1 diabetes
to disclose the status of clinical development, including the applicable clinical
trials, for each product candidate.
RESPONSE:
Per the Staff’s comment, we have revised the discussion of the Company’s competitors developing therapies to treat
Type 1 diabetes on pages 10 and 11 to disclose the status of clinical development, including the applicable clinical
trials, for each product candidate.
Division
of Corporate Finance
U.S.
Securities and Exchange Commission
March
20, 2020
Page
3
Government
Regulation, page 14
5. We
note your discussion of Fast Track, Breakthrough therapy, Proprietary Review Designations
and Accelerated Approval pathway programs. Please clarify that you
currently do not qualify for any of these programs.
RESPONSE:
Per the Staff’s comment, we have added on pages 17 and 18 that the Company’s product candidates
do not qualify for the Fast Track, Breakthrough therapy, Proprietary Review Designations and Accelerated Approval pathway programs.
Risk
Factors
We
will need to obtain financing to implement our business plan, page 33
6. Please
quantify the funding you will need and how far in the development process you
expect to get with this amount of funding.
RESPONSE:
Per the Staff’s comment, we have revised the risk factor on page 32 to quantify that the Company estimates
it will need to complete a financing raise of approximately $15 million to reach the completion of phase one of the clinical trials
in diabetic patients.
The
application of the “penny stock” rules could adversely affect the market price of our common stock..., page 42
7. Please
expand your disclosure to discuss if and how these “penny stock” rules apply
to the company.
RESPONSE:
Per the Staff’s comment, we have revised the risk factor on page 41 to discuss that the Company’s common
stock is quoted on the OTC Markets’ Pink tier and that the penny stock rules have and may continue to apply to the Company.
Management’s
Discussion and Analysis of Financial Condition and Results of Operations Liquidity and Capital Resources, page 44
8. We
note your disclosure that you do not believe you have enough cash on hand to operate
your business during the next twelve months. Please expand your disclosure to provide
the estimated amount of cash you believe will be necessary to fund your operations over
the next twelve months. In addition, revise your disclosure in Management’s Discussion
and Analysis and in the notes to the financial statements to clarify how you intend to
raise the additional funds. Refer to ASC
205-40-50.
RESPONSE:
Per the Staff’s comment, we have updated the Liquidity and Capital Resources section in the MD&A disclosures on
page 43 to disclose that the Company estimates that it will need $1 million in cash to fund its operations for the next
twelve months. In addition, the Company has revised its disclosure in the notes to the financial statements on page F-10 to clarify
that the Company intends to raise the additional funds in 2020.
Division
of Corporate Finance
U.S.
Securities and Exchange Commission
March
20, 2020
Page
4
Security
Ownership of Certain Beneficial Owners and Management, page 51
9. Please
add an additional column to your beneficial ownership table to indicate the total
voting power of each beneficial owner before and after the conversion of the preferred
shares.
RESPONSE:
Per the Staff’s comment, we have added an additional column to the beneficial ownership table on pages 50 to 52
to indicate the voting power of each beneficial owner before and after the conversion of the Series A Preferred Stock and Series
B Preferred Stock.
10. We
note that you state in Footnote (1) to the beneficial ownership table that the Series
A and Series B preferred shares automatically convert upon the filing of this Form 10.
We also note that you state at pages 65 and 66 that your preferred shares convert, among
other circumstances, on the one year anniversary
of the filing of a Form 10. Please reconcile these statements.
RESPONSE:
Per the Staff’s comment, we have revised Footnote (1) to the beneficial ownership table on page 51 to automatically
convert upon the one year anniversary of the Form 10.
Certain
Relationships and Related Transactions, and Director Independence, page 58
11. We
note that you disclose that Massachusetts General Hospital is the beneficial owner of
20.5% of your common shares. If applicable, please identify the MGH License agreement
as a related party transaction. You may cross-reference your earlier discussion of the
terms of this license agreement.
RESPONSE:
We have revised the language on page 59 to indicate that due to MGH’s 20.5% beneficial ownership of the Company’s
common stock, the MGH License Agreement is deemed to be a related party transaction and include a cross-reference the earlier
discussion of the terms of the MGH License Agreement under Item 1 of the Form 10.
If
the Staff has any further comments regarding Amendment No. 1, please feel free to contact the undersigned.
Anthony
L.G., PLLC
By:
/s/
Philip Magri
Philip
Magri, Esq.
cc:
Tracie
Mariner – SEC
Mary
Mast – SEC
Courtney
Lindsay – SEC
Suzanne
Hays – SEC
Frances
Toneguzzo – Vicapsys
Jeff
Wright – Vicapsys