SEC Company Response from Processa Pharmaceuticals, Inc. (PCSA) (CIK 0001533743) (PCSA) — Sep 14, 2018
Processa Pharmaceuticals, Inc. (PCSA) (CIK 0001533743)
Date: Sept. 14, 2018 · CIK: 0001533743 · Accession: 0001493152-18-013265
AI Filing Summary & Sentiment
File numbers found in text: 333-226428
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ATTORNEYS
AT LAW
One
Independent Drive, Suite 1300
Jacksonville,
FL 32202-5017
904.359.2000
TEL
904.359.8700
FAX
www.foley.com
WRITER’S
DIRECT LINE
904.633.8913
mkirwan@foley.com
EMAIL
CLIENT/MATTER
NUMBER
100830-0118
September
14, 2018
Via
EDGAR
United
States Securities and Exchange Commission
Division
of Corporate Finance
Washington,
D.C. 20549
Re: Processa
Pharmaceuticals, Inc.
Registration
Statement on Form S-1
Filed
July 30, 2018
File
No. 333-226428
Dear
Ladies and Gentlemen,
On
behalf of Processa Pharmaceuticals, Inc. ( “the Company” or “Processa”), we are responding to the comments
of the staff of the Division of Corporate Finance, Office of Healthcare and Insurance of the United States Securities and Exchange
Commission set forth in your letter to Dr. David Young, Processa’s Chief Executive Officer, dated August 28, 2018. Your
comments are reproduced below in bold, followed in each case by our response on behalf of the Company.
Registration
Statement on Form S-1
Cover
Page
1. We
note your disclosure that your common stock is quoted on the OTC Pink Market. Please
revise here, and make corresponding changes elsewhere in the prospectus, to disclose
a fixed price at which your shares will be sold until your shares are listed on a national
securities exchange or quoted on the OTC Bulletin Board, OTCQB or OTCQX.
Response
The
Company has revised the Prospectus cover page to reflect that the Company is making an application to the OTCQB and that Selling
Stockholders will offer the shares of common stock at a fixed price until the Company’s common stock is approved for trading
on the OTCQB. The Company has made similar disclosures in the following sections of the prospectus: Prospectus Summary,
Risk Factors, Market Price of Our Common Stock and Related Stockholder Matters, and Plan of Distribution.
AUSTIN
Boston
CHICAGO
dallas
DENVER
DETROIT
houston
JACKSONVILLE
LOS
ANGELES
MADISON
MEXICO
CITY
MIAMI
MILWAUKEE
NEW
YORK
ORLANDO
SACRAMENTO
SAN
DIEGO
SAN
FRANCISCO
SILICON
VALLEY
TALLAHASSEE
TAMPA
WASHINGTON,
D.C.
BRUSSELS
TOKYO
September
14, 2018
Page
2
Description
of Business, page 1
2. Please
provide more detail concerning the current stage of development of PCS-499 in this section
such as whether PCS-499 is in the preclinical stage of development and whether you have
conducted any clinical trials for PCS-499, filed any regulatory applications or had any
pre-filing conferences with regulatory agencies.
Response
The
Company has revised Prospectus Summary - Description of Business to provide more detail concerning the current stage of
development of PCS-499 and the status of clinical trials, regulatory applications and pre-filing conferences with regulatory agencies.
Prospectus
Summary, page 1
3. Please
revise your disclosure to briefly explain in terms a lay reader would understand what
you mean that your product candidate is an “analog of an active metabolite”
of an already approved drug. Please also disclose the drug that is already approved,
when it was approved, the indication for which it was approved, and the fact that it
was approved by the FDA as disclosed elsewhere in the prospectus.
Response
The
Company has expanded Prospectus Summary - Description of Business to explain, in terms a lay reader would understand, that
PCS-499 has a structure similar to that of an approved drug, but differing from it with respect to a certain functional component
of the molecule.
The
Company has further disclosed the name and approved indications of the FDA approved analog.
4. We
note your statement here, and elsewhere in the prospectus, that your lead product candidate
compound has been shown to be “safe and tolerable” and “with a trend
toward efficacy in diabetic nephropathy.” Safety and efficacy determinations are
solely within the authority of the FDA and comparable regulatory authorities. Please
revise your disclosure to remove all references to your product candidate as being effective,
including preliminary indications of efficacy (whether for your planned indication or
other indications). Please make similar revisions regarding your statements about your
product candidate’s safety. In the “Description of Business” section,
you may present the objective results of trials.
September
14, 2018
Page
3
Response
The
Company has revised the Prospectus to remove all references to PCS-499 as being effective, including removal of references to
preliminary indications of efficacy. Furthermore, the Company has made similar revisions regarding the safety of PCS-499.
Risk
Factors, page 1
5. Please
expand this section to disclose that you do not own any patents for your drug candidate
and you are dependent on a license. Please also disclose in this section that you have
not initiated any clinical trials and your independent registered public accounting firm’s
doubt about your ability to continue as a going concern.
Response
The
Company has expanded Prospectus Summary - Risk Factor to disclose that (1) the Company does not own any patents for its
drug candidates and is dependent on licenses; (2) the Company has not initiated any clinical trials and (3) the Company’s
independent registered public accounting firm has expressed doubt about the Company’s ability to continue as a going concern.
Risk
Factors, page 6
6. Please
add a risk factor to discuss the fact that you do not currently have an audit or compensation
committee and that only one of your directors is independent.
Response
The
Company has included a new risk factor to discuss that the Company does not currently have an audit committee or compensation
committee and that the Company does not currently have a majority of independent directors.
September
14, 2018
Page
4
We
depend on rights to certain pharmaceutical compounds that are or will be licensed to us, page 15
7. We
note your disclosure in this risk factor that your drugs are in-licensed from other biotech
or pharmaceutical companies and that you do not own the patents that underlie these licenses.
Please specify the product candidates that you are referring to as well as the patents
and the biotech or pharmaceutical companies from whom you have licensed such patents.
Response
The
Company has revised the Risk Factors relating to its intellectual property rights to specify the licensed product candidates as
well as the patents and biotech or pharmaceutical companies from whom the patents have been licensed.
There
may be limitations on the effectiveness of our internal controls, page 19
8. We
note your disclosure that you experienced a cybersecurity breach that resulted in a fraud
loss where the probability of recovery of the loss is remote. Please disclose when the
breach occurred and quantify the loss in this risk factor.
Response
The
Company has revised its disclosure to include the date and dollar value of the loss suffered by the Company as a result of the
cybersecurity breach.
Our
principal stockholders have significant influence over us, . . ., page 21
9. Please
expand this risk factor to also discuss the combined ownership of your 5% stockholders
in addition to your executive officers, directors, and their affiliates.
Response
The
Company has expanded this risk factor to discuss the combined ownership of the Company’s 5% stockholders in addition to
its executive officers, directors, and their affiliates.
Liquidity
and Capital Resources, page 30
10. Please
disclose how long you expect your business operations to continue given your current
amount of cash and funds. If you expect that your business operations cannot continue
given your current amount of cash and funds, please disclose the amount of additional
financing necessary to continue operations.
September
14, 2018
Page
5
Response
The
Company has expanded Liquidity and Capital Resources to include the expected continuation of business operations given
the Company’s current and projected cash flow and funds.
Description
of Business, page 37
11. We
note your disclosure on page 37 regarding your team’s prior experience developing
drug products. Please revise your disclosure to provide balancing language that the prior
experience of your team is not an indication of a similar result with respect to Processa.
Response
The
Company has added balancing language to such disclosure stating that the prior experience of the Company’s team is not a
guarantee of a similar result in the future.
12. We
refer to your statement that your business strategy is to identify drugs that can be
“quickly” developed within “2-4 years.” Please tell us why you
believe this time frame is realistic given the lengthy and uncertain process of seeking
regulatory approval.
Response
The
Company has expanded the description of its business model to explain the justification for identification of drugs that can be
quickly developed within 2-4 years.
13. We
note your statement that part of your business strategy is to identify drugs that have
potential efficacy in patients with an unmet medical need, even if the evidence is “anecdotal.”
Please revise this disclosure to explain how you would consider anecdotal information
to serve as clinical evidence.
Response
The
Company has revised Description of Business to explain utilization of published case studies or clinical studies to serve
as clinical evidence.
14. Please
quantify your funding obligations under your CRO agreement with Integrium, LLC to conduct
your planned Phase 2 study for PCS-499 in the treatment of NL. Please also disclose whether
the $1.8 million that will be paid directly to Integrium by the investor will be sufficient
to complete the planned Phase 2 clinical trial.
September
14, 2018
Page
6
Response
The
Company has revised Description of Business to include an explanation of the terms of the Company’s CRO agreement
with Integrium, including explanation of funding obligations and sufficiency of funds to complete the planned Phase 2 clinical
trials.
15. Expand
your disclosure to explain how you identified Necrobiosis Lipoidica (NL) and Radiation-Induced
Fibrosis (RIF) in head and neck cancer patients as indications for which PCS-499 may
result in clinical efficacy.
Response
The
Company has revised Description of Business to explain the process of identification of NL and RIF in head and neck cancer
patients as indications for which PCS-499 may result in clinical efficacy.
16. We
note your disclosure that you intend to pursue a Phase 2 clinical trial for PCS-499.
Please disclose how you will proceed to a Phase 2 trial given that it appears that you
have not conducted any Phase 1 clinical trials and disclose the regulatory pathway that
you intend to pursue. Please expand your disclosure to discuss specific trial results
for your product candidate on which you intend to rely, including the duration of the
trial, the number of subjects or patients in such trials, how the drug candidate was
administered, who conducted the trials, the dosage used, any serious adverse events experienced,
the primary and secondary endpoints and whether they were met.
Response
The
Company revised Description of Business to further explain that due to previous preclinical studies, Phase 1 and Phase
2 clinical work completed in support of PCS-499, the Company anticipates moving the product into Phase 2 studies for the new indications.
Asset
Acquisition, page 38
17. Please
revise this section to discuss the material terms of your CoNCERT agreement, including
the nature and scope of the intellectual property transferred, each parties’ duties
and obligations, the term of the agreement, the royalty term, the royalty rates, the
termination provisions and any potential milestone payments. We also note the discussion
on page F-26 concerning CoNCERT’s right to have one Board observer attend the Promet’s
Board meetings. If CoNCERT still has that right with respect to Processa’s Board
meetings, please discuss it here.
September
14, 2018
Page
7
Response
The
Company has revised Description of Business to include a new sub-section titled “- License Agreement with CoNCERT
Pharmaceuticals, Inc.” that describes the material terms of the Company’s license agreement with CoNCERT Pharmaceuticals,
Inc. Please note that CoNCERT Pharmaceut