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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

Date
Sept. 14, 2018
Author
Not clearly detected
Form
CORRESP
Company
Processa Pharmaceuticals, Inc. (PCSA) (CIK 0001533743)

Letter

Via EDGAR United States Securities and Exchange Commission Division of Corporate Finance 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

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

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

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

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

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

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

Show Raw Text
CORRESP
1
filename1.htm

    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