May 28, 2019
Craig Ellins
Chief Executive Officer
One World Pharma, Inc.
3471 West Oquendo Road, Suite 301
Las Vegas, NV 89118
Re: One World Pharma, Inc.
Amendment No. 1 to Current Report on Form 8-K
Filed April 30, 2019
File No. 333-200529
Dear Mr. Ellins:
We have reviewed your filing and have the following comments. In some of
our
comments, we may ask you to provide us with information so we may better
understand your
disclosure.
Please respond to these comments within ten business days by providing
the requested
information or advise us as soon as possible when you will respond. If you do
not believe our
comments apply to your facts and circumstances, please tell us why in your
response.
After reviewing your response to these comments, we may have additional
comments.
Amendment No. 1 to Form 8-K
Description of the Business, page 2
1. Please revise this section to disclose in greater detail the current
stage of your business,
including your principal products and their pricing, distribution
methods, status of new
products, and your target market(s). Refer to Item 101(h) of Regulation
S-K. Your
disclosure should clearly state the current status of development, the
steps you have taken
toward your planned operations, your intended customers and the market(s)
in which
you plan to distribute your products, your anticipated timeline, and the
steps that remain.
2. We note your statement that you plan to be the "worldwide industry
leader" in the
production and manufacturing of raw cannabis and hemp plant ingredients.
Given the
substantial competition in the industry, please tell us why you believe
you could be the
worldwide industry leader. Please also explain what it means that you are
planning to use
raw cannabis and hemp plant ingredients for "industrial use."
Craig Ellins
FirstName LastNameCraig Ellins
One World Pharma, Inc.
Comapany NameOne World Pharma, Inc.
May 28, 2019
May 28, 2019 Page 2
Page 2
FirstName LastName
3. Please revise to disclose what you mean by "cannabis micropropagation
techniques" and
the basis for your belief that these techniques cultivate genetically
superior cannabis and
hemp derived products. Please also explain what you mean by
"GAP/GMP/EU
Pharmacopoeia standards."
History and Background, page 3
4. Please disclose that these licenses were granted by the Colombian
government. Please
also disclose the grant dates and expiration dates for each of your
licenses. Please also
clarify whether these licenses will permit you to export your products
outside of
Colombia.
Industry, page 4
5. We note your disclosure on page 4 which you broadly cite "[v]arious
third-party studies"
to support the suggestion that medicinal cannabis has shown, or has
the potential to show,
efficacy for the treatment of a number of diseases. Conclusions
regarding efficacy are
generally within the sole authority of the relevant government entity
regulating drugs.
Please delete the statements in this section stating that medical
cannabis is effective in
treating various diseases unless you can indicate that a specific drug
has been approved by
a regulatory entity for the treatment of an identified indication. You
may replace these
statements with descriptions of the third-party studies or clinical
trials and the resulting
data, without drawing conclusions as to efficacy. The discussion
should include all
material information about the studies or trials, including the name
of the person
conducting the trial or study and the structure of the trial or study.
Regulation, page 4
6. Please revise this section to clearly explain existing or probable
governmental regulations
on your business. Please ensure that your disclosure addresses any
approval you may
need from any government entity to operate your business as currently
contemplated,
including the National Food and Drug Surveillance Institute and the
National Narcotics
Fund, as well as any regulations governing the export and import of
your product, as
contemplated by your business. Your disclosure should include
applicable regulations in
your targeted markets. Please also clarify whether you intend to sell
your products in the
U.S. market. Please expand your disclosure to discuss the activities
conducted at your
principal executive office, and state whether you believe you will be
subject to the U.S.
Controlled Substances Act or the Controlled Substances Import and
Export Act or subject
to regulation by the U.S. Food and Drug Administration. Refer to Item
101(h)(4)(ix) of
Regulation S-K.
7. Please discuss the quota amounts you have for the current calendar
year, including
whether your quotas are crop quotas or manufacturing quotas and
whether they are
sufficient to cover current plans for your business.
Craig Ellins
FirstName LastNameCraig Ellins
One World Pharma, Inc.
Comapany NameOne World Pharma, Inc.
May 28, 2019
May 28, 2019 Page 3
Page 3
FirstName LastName
Risk Factors
United States Regulation, page 11
8. This risk factor assumes approval to distribute your products in the
United States. Please
disclose the approval you would need to enter the U.S. market and
disclose that your
operations could be found in violation of the U.S. federal Controlled
Substances Act.
Directors and Executive Officers, Promoters and Control Persons, page 20
9. Please provide clear disclosure regarding the business experience of
Bruce Raben and Dr.
Kenneth Perego, II during the past five years, including in each case
their principal
occupation and employment, the dates they served in those roles and
the name and
business of any corporation or other organization in which such
occupation and
employment was carried on, as required by Item 401(e)(1) of Regulation
S-K. In
particular, please discuss Dr. Kenneth Perego's involvement with CB
Medical, LLC.
Executive Compensation, page 21
10. You indicate in this section that you paid Mr. Ellins a salary in
2018, but the disclosure in
your Form 10-K for the fiscal year ended December 31, 2018 states that
you did not pay
any compensation to any director or executive officer. Please
reconcile your disclosure.
Recent Sales of Unregistered Securities, page 25
11. We note that from September 2, 2014 through immediately prior to the
Merger, you sold
or issued an aggregate of 447,500 shares of common stock to officers,
directors,
employees, and other investors for cash, services rendered and
services to be rendered.
We further note your disclosure on page 8 that you raised $1,950,000
from the sale of
common stock subsequent to December 31, 2018. Please revise to
disclose all securities
sold by you within the past three years that were not registered under
the Securities Act.
Please include all information required by Item 701 of Regulation S-K,
including the date
of the sale and the title and amount of securities, the name or
identify the class of persons
to whom the securities were sold, consideration, and the exemption
from
registration claimed.
Exhibit Index , page 28
12. We note your disclosure on page 2 that you have 221 acres available
for expansion under
an exclusive contract. Please file this agreement as exhibit or tell
us why you do not
believe you are required to do so.
Craig Ellins
FirstName LastNameCraig Ellins
One World Pharma, Inc.
Comapany NameOne World Pharma, Inc.
May 28, 2019
May 28, 2019 Page 4
Page 4
FirstName LastName
Exhibt 99.2
OWP Ventures, Inc. Audited Financial Statements
Notes to Consolidated Financial Statements
Note 3 - Acquisition, page F-10
13. Please address each of the following:
As One World Pharma SAS appears to be OWP Ventures, Inc.'s
predecessor, include,
in the filing, audited statements of operations and cash flows for
One World Pharma
SAS for the period January 1, 2018 through May 30, 2018.
Provide us an analysis supporting the $162,051 fair value of total
consideration
transferred. Include in your response the basis for valuing OWP
Ventures, Inc.'s
10,200,000 shares of common stock at $0.0001 per share and what
other current
liabilities of $168,548 represents. Tell us how your accounting
complies with ASC
805-30-30-1, 30-2 and 30-7.
Explain to us your consideration with regard to the four licenses
received by One
World Pharma SAS as indicated under "Background and History" on
page 3 of your
filing in determining the identifiable assets acquired and the
liabilities assumed. Tell
us how your accounting complies with ASC 805-20.
Tell us why the "Consideration paid in excess of fair value
(Negative
Goodwill)" resulted in recording a credit to additional paid-in
capital rather than a
debit to goodwill, an asset, pursuant to ASC 805-30-30-1.
Note 4 - Investment, page F-10
14. Please provide us an analysis with reference to authoritative
literature supporting you
accounting for the acquisition of 875,000 shares of the issued and
outstanding common
stock, on a 1:4 split adjusted basis, of One World Pharma, Inc. from
the majority
shareholder for $350,000 as a business combination including whether
the assets acquired
and liabilities assumed constitute a business. Further, support for us
with reference to
authoritative literature your accounting treatment for the $349,420
goodwill as "additional
paid-in capital due to the subsequent reverse merger."
Exhibit 99.3
Note 2 Pro Forma Adjustments, page 5
15. If OWP Ventures, Inc. is the accounting acquirer in the merger
transaction, provide us
your analysis supporting your presentation of the accumulated deficit
and other equity
balances, as adjusted for shares outstanding after the merger, of One
World Pharma, Inc.
as the historical results of the combined company rather than that of
OWP Ventrues,
Inc. Refer to ASC 805-40-45-2.
We remind you that the company and its management are responsible for
the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action
or absence of
action by the staff.
Craig Ellins
One World Pharma, Inc.
May 28, 2019
Page 5
You may contact Rolf Sundwall at 202-551-3105 or Jim Rosenberg at
202-551-3679 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Jeffrey Gabor at 202-551-2544 or Erin Jaskot at 202-551-3442 with any
other questions.
Sincerely,
FirstName LastNameCraig Ellins
Division of
Corporation Finance
Comapany NameOne World Pharma, Inc.
Office of Healthcare
& Insurance
May 28, 2019 Page 5
cc: Alison Newman, Esq.
FirstName LastName