SecProbe.io

<DOCUMENT>
<TYPE>TEXT-EXTRACT
<SEQUENCE>2
<FILENAME>filename2.txt
<TEXT>
 August 13, 2025

Russell Skibsted
Chief Financial Officer
Processa Pharmaceuticals, Inc.
601 21st Street, Suite 300
Vero Beach, FL, 32960

 Re: Processa Pharmaceuticals, Inc.
 Preliminary Proxy Statement on Schedule 14A
 Filed July 31, 2025
 File No. 001-39531
Dear Russell Skibsted:

 We have completed our review of your filing. 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.

 Sincerely,

 Division of Corporation
Finance
 Office of Life Sciences
cc: Michael Kirwan
</TEXT>
</DOCUMENT>

CORRESP
 1
 filename1.htm

 Processa
Pharmaceuticals, Inc.

 August
8, 2025

 Via
EDGAR

 U.S.
Securities and Exchange Commission

 Division
of Corporation Finance

 100
F. Street, N.E.

 Washington,
D.C. 20549

 Attention:
 Mr.
 Chris Edwards

 Mr.
 Joe McCann

 Re:
 Processa
 Pharmaceuticals, Inc.

 Preliminary
 Proxy Statement on Schedule 14A

 Filed
 July 31, 2025

 File
 No. 001-39531

 This
letter is in response to the comment of the Staff (the " Staff ") of the Securities and Exchange Commission (the " Commission "),
as set forth in your letter dated August 6, 2025 regarding the preliminary proxy statement filed by Processa Pharmaceuticals, Inc. (the
" Company ") with the Commission on July 31, 2025. For convenience, the full text of the Staff's comment is set
forth below in bold and italics, followed by the Company's response.

 Preliminary
Proxy Statement on Schedule 14A

 General

 1. Please
 revise the preliminary proxy statement to fill in the number of authorized shares in proposal
 number 1 and the reverse stock split ratios in proposal number 2.

 Response:
The Company has revised the preliminary proxy statement to fill in the number of authorized shares in proposal number 1 and the reverse
stock split ratios in proposal number 2, as requested.

 If
you have any questions or require any additional information in connection with the filing of the revised preliminary proxy statement,
please contact me at (772) 453-2899.

 Sincerely,

 /s/
 Russell Skibsted

 Russell
 Skibsted

 Chief
Financial Officer

<DOCUMENT>
<TYPE>TEXT-EXTRACT
<SEQUENCE>2
<FILENAME>filename2.txt
<TEXT>
 August 6, 2025

Russell Skibsted
Chief Financial Officer
Processa Pharmaceuticals, Inc.
601 21st Street, Suite 300
Vero Beach, FL, 32960

 Re: Processa Pharmaceuticals, Inc.
 Preliminary Proxy Statement on Schedule 14A
 Filed July 31, 2025
 File No. 001-39531
Dear Russell Skibsted:

 We have reviewed your filing and have the following comment.

 Please respond to this letter 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 a
comment applies to your facts and circumstances, please tell us why in your
response. After
reviewing your response to this letter, we may have additional comments.

Preliminary Proxy Statement on Schedule 14A
General

1. Please revise the preliminary proxy statement to fill in the number of
authorized
 shares in proposal number 1 and the reverse stock split ratios in
proposal number 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.

 Please contact Chris Edwards at 202-551-6761 or Joe McCann at
202-551-6262 with
any questions.

 Sincerely,

 Division of
Corporation Finance
 Office of Life
Sciences
</TEXT>
</DOCUMENT>

CORRESP
 1
 filename1.htm

 Processa
Pharmaceuticals, Inc.

 7380
Coca Cola Drive, Suite 106

 Hanover,
Maryland 21076

 June
13, 2025

 VIA
EDGAR

 United
States Securities and Exchange Commission

 Division
of Corporation Finance

 100
F Street, NE

 Washington,
D.C. 20549

 Attention:
Mr. Chris Edwards

 Re: Processa
 Pharmaceuticals, Inc.

 Registration
 Statement on Form S-1 (Registration No. 333-287997)

 Ladies
and Gentlemen:

 Pursuant
to Rule 461 under the Securities Act of 1933, as amended, the undersigned registrant, Processa Pharmaceuticals, Inc. (the "Registrant"),
hereby requests acceleration of effectiveness of its above-referenced Registration Statement to 5:15 P.M., Eastern time, on June 16,
2025, or as soon as practicable thereafter. The Registrant respectfully requests that you notify Mr. Michael Kirwan of Foley & Lardner
LLP of such effectiveness by a telephone call to (904) 633-8913.

 Very
 truly yours,

 Processa
 Pharmaceuticals, Inc.

 By:
 /s/
 George Ng

 George
 Ng

 Chief
 Executive Officer

CORRESP
 1
 filename1.htm

 June
13, 2025

 VIA
FACSIMILE AND EDGAR

 U.S.
Securities and Exchange Commission

 Division
of Corporate Finance

 Washington,
DC 20549

 Re:
 Processa Pharmaceuticals, Inc.

 Registration
Statement on Form S-1 (Registration No. 333-287997) -

 Concurrence
in Acceleration Request

 Ladies
and Gentlemen:

 H.C.
Wainwright & Co., LLC (" Wainwright "), solely acting as placement agent on a best-efforts basis in an offering
pursuant to the registration statement on Form S-1 (333-287997) (the " Registration Statement "), hereby concurs
in the request by Processa Pharmaceuticals, Inc. that the effective date of the above-referenced registration statement be accelerated
to 5:15 P.M. Eastern Time on Monday, June 16, 2025, or as soon as practicable thereafter, pursuant to Rule 461 under the Securities Act.
Wainwright affirms that it is aware of its obligations under the Securities Act as they pertain to the best efforts offering pursuant
to the Registration Statement.

 Very truly yours,

 H.C. WAINWRIGHT & CO., LLC

 By:
 /s/
 Edward D. Silvera

 Name:
 Edward D. Silvera

 Title:
 Chief Operating Officer

 430 Park Avenue | New York, NY 10022 | 212.356.0500
| www.hcwco.com

 Member: FINRA/SIPC

<DOCUMENT>
<TYPE>TEXT-EXTRACT
<SEQUENCE>2
<FILENAME>filename2.txt
<TEXT>
 May 7, 2025

George Ng
Chief Executive Officer
Processa Pharmaceuticals, Inc.
7380 Coca Cola Drive, Suite 106
Hanover, Maryland 21076

 Re: Processa Pharmaceuticals, Inc.
 Draft Registration Statement on Form S-1
 Submitted May 1, 2025
 CIK No. 0001533743
Dear George Ng:

 This is to advise you that we do not intend to review your registration
statement.

 We request that you publicly file your registration statement at least
two business
days prior to the requested effective date and time. Please refer to Rules 460
and 461
regarding requests for acceleration. 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.

 Please contact Chris Edwards at 202-551-6761 with any questions.

 Sincerely,

 Division of
Corporation Finance
 Office of Life
Sciences
cc: Neda Sharifi
</TEXT>
</DOCUMENT>

CORRESP
1
filename1.htm

January
27, 2025

VIA
EDGAR

U.S.
Securities and Exchange Commission

Division
of Corporation Finance

100
F Street, N.E.

Washington,
D.C. 20549

Attention:
Mr. Christopher Edwards

    Re:
    Processa Pharmaceuticals, Inc.

    Registration
    Statement on Form S-1

    Registration
    No. 333-283986

Ladies
and Gentlemen:

In
accordance with Rule 461 of the General Rules and Regulations promulgated under the Securities Act of 1933, as amended (the “Act”),
A.G.P./ALLIANCE GLOBAL PARTNERS, as Sole Placement Agent (the “Placement Agent”), hereby joins Processa Pharmaceuticals,
Inc. (the “Company”) in requesting that the Securities and Exchange Commission take appropriate action to cause the Registration
Statement on Form S-1, as amended (the “Registration Statement”), to become effective as of 4:30 p.m., Eastern Time, on January
27, 2025, or as soon thereafter as is practicable, or at such other time as the Company or its outside counsel, Foley & Lardner LLP,
request by telephone that such Registration Statement be declared effective.

Pursuant
to Rule 460 of the General Rules and Regulations under the Act, the undersigned advises that copies of the Preliminary Prospectus, dated
January 27, 2025, are expected to be distributed to prospective dealers, institutional investors, retail investors and others as appears
to be reasonable to secure adequate distribution of the Preliminary Prospectus.

The
Placement Agent is aware of its obligations under, and confirm that it is complying with, the provisions of Rule 15c2-8 under the Securities
Exchange Act of 1934, as amended, including the delivery requirement contained in such Rule.

      Very
                                            truly yours,

      A.G.P./ALLIANCE
                                            GLOBAL PARTNERS

      By:
    /s/
    Thomas J. Higgins

      Name:
    Thomas J. Higgins

      Title:
    Managing Director

CORRESP
1
filename1.htm

Processa
Pharmaceuticals, Inc.

7380
Coca Cola Drive, Suite 106

Hanover,
Maryland 21076

January
27, 2025

VIA
EDGAR

United
States Securities and Exchange Commission

Division
of Corporation Finance

100
F Street, NE

Washington,
D.C. 20549

Attention:
Mr. Christopher Edwards

  Re:
  Processa Pharmaceuticals,
  Inc.

  Registration Statement
  on Form S-1 (Registration No. 333-283986)

Ladies
and Gentlemen:

Pursuant
to Rule 461 under the Securities Act of 1933, as amended, the undersigned registrant, Processa Pharmaceuticals, Inc. (the “Registrant”),
hereby requests acceleration of effectiveness of its above-referenced Registration Statement to 4:30 P.M., Eastern time, on January
27, 2025, or as soon as practicable thereafter. The Registrant respectfully requests that you notify Mr. Michael Kirwan of Foley &
Lardner LLP of such effectiveness by a telephone call to (904) 633-8913.

    Very truly yours,

    Processa Pharmaceuticals, Inc.

    By:
  /s/ George
  Ng

  George Ng

  Chief Executive Officer

CORRESP
1
filename1.htm

Processa
Pharmaceuticals, Inc.

7380
Coca Cola Drive, Suite 106,

Hanover,
Maryland 21076

January
23, 2025

VIA
EDGAR

United
States Securities and Exchange Commission

Division
of Corporation Finance

100
F Street, NE

Washington,
D.C. 20549

Attention:
Mr. Christopher Edwards

  Re:
  Processa Pharmaceuticals, Inc.

  Registration Statement on Form S-1 (Registration No.
  333-283986)

Ladies
and Gentlemen:

Reference
is made to our letter to you dated January 17, 2025 (the “Acceleration Request”) to request that the Processa Pharmaceuticals,
Inc. Registration Statement on Form S-1 (Registration No. 333-283986) be declared effective at 5:00 p.m., Eastern time, on January 23,
2025, or as soon as practicable thereafter. We now respectfully withdraw the Acceleration Request.

The
Registrant respectfully requests that you contact Michael Kirwan of Foley & Lardner LLP by telephone call to (904) 633-8913 with
any questions or requests for additional information.

  Very truly yours,

  Processa Pharmaceuticals, Inc.

  By:
  /s/ George Ng

  George Ng

  Chief Executive Officer

CORRESP
1
filename1.htm

January
23, 2025

VIA
EDGAR

U.S.
Securities and Exchange Commission

Division
of Corporation Finance

100
F Street, N.E.

Washington,
D.C. 20549

Attention:
Mr. Christopher Edwards

    Re:
    Processa
    Pharmaceuticals, Inc.

    Registration
    Statement on Form S-1

    Registration
    No. 333-283986

Ladies
and Gentlemen:

Reference
is made to our letter, dated January 17, 2025, in which we, as Sole Placement Agent for the proposed offering by Processa Pharmaceuticals,
Inc. (the “Company”), joined the Company’s request for acceleration of the effective date of the above-referenced
registration statement (the “Registration Statement”) for January 23, 2025, at 5:00 p.m., Eastern Time. The Company
is no longer requesting that such Registration Statement be declared effective at this time, and we hereby formally withdraw our request
for acceleration of the effective date of the Registration Statement.

    Very truly yours,

    A.G.P./ALLIANCE GLOBAL PARTNERS

    By:
    /s/
    Thomas J. Higgins

    Name:
     Thomas J. Higgins

    Title:
    Managing
Director

CORRESP
1
filename1.htm

January
17, 2025

VIA
EDGAR

U.S.
Securities and Exchange Commission

Division
of Corporation Finance

100
F Street, N.E.

Washington,
D.C. 20549

Attention:
Mr. Christopher Edwards

  Re:
  Processa Pharmaceuticals, Inc.

  Registration Statement on Form S-1

  Registration No. 333-283986

Ladies
and Gentlemen:

In
accordance with Rule 461 of the General Rules and Regulations promulgated under the Securities Act of 1933, as amended (the “Act”),
A.G.P./ALLIANCE GLOBAL PARTNERS, as Sole Placement Agent (the “Placement Agent”), hereby joins Processa Pharmaceuticals,
Inc. (the “Company”) in requesting that the Securities and Exchange Commission take appropriate action to cause the Registration
Statement on Form S-1, as amended (the “Registration Statement”), to become effective as of 5:00 p.m., Eastern Time, on January
22, 2025, or as soon thereafter as is practicable, or at such other time as the Company or its outside counsel, Foley & Lardner LLP,
request by telephone that such Registration Statement be declared effective.

Pursuant
to Rule 460 of the General Rules and Regulations under the Act, the undersigned advises that copies of the Preliminary Prospectus, dated
January 16, 2025, are expected to be distributed to prospective dealers, institutional investors, retail investors and others as appears
to be reasonable to secure adequate distribution of the Preliminary Prospectus.

The
Placement Agent is aware of its obligations under, and confirm that it is complying with, the provisions of Rule 15c2-8 under the Securities
Exchange Act of 1934, as amended, including the delivery requirement contained in such Rule.

  Very truly yours,

  A.G.P./ALLIANCE
  GLOBAL PARTNERS

  By:
  /s/ Thomas J. Higgins

  Name:
  Thomas J. Higgins

  Title:
  Managing Director

CORRESP
1
filename1.htm

Processa
Pharmaceuticals, Inc.

7380
Coca Cola Drive, Suite 106

Hanover,
Maryland 21076

January
17, 2025

VIA
EDGAR

United
States Securities and Exchange Commission

Division
of Corporation Finance

100
F Street, NE

Washington,
D.C. 20549

Attention:
Mr. Christopher Edwards

  Re:
  Processa Pharmaceuticals, Inc.

  Registration Statement on Form S-1 (Registration No. 333-283986)

Ladies
and Gentlemen:

Pursuant
to Rule 461 under the Securities Act of 1933, as amended, the undersigned registrant, Processa Pharmaceuticals, Inc. (the “Registrant”),
hereby requests acceleration of effectiveness of its above-referenced Registration Statement to 5:00 P.M., Eastern time, on January 22,
2025, or as soon as practicable thereafter. The Registrant respectfully requests that you notify Mr. Michael Kirwan of Foley & Lardner
LLP of such effectiveness by a telephone call to (904) 633-8913.

  Very truly yours,

  Processa Pharmaceuticals, Inc.

  By:
  /s/ George Ng

  George Ng

  Chief Executive Officer

December 28, 2024
George Ng
Chief Executive Officer
Processa Pharmaceuticals, Inc.
7380 Coca Cola Drive, Suite 106
Hanover, Maryland 21076
Re:Processa Pharmaceuticals, Inc.
Registration Statement on Form S-1
Filed December 20, 2024
File No. 333-283986
Dear George Ng:
            This is to advise you that we have not reviewed and will not review your registration
statement.
            Please refer to Rules 460 and 461 regarding requests for acceleration. 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.
            Please contact Chris Edwards at 202-551-6761 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Neda Sharifi

CORRESP
1
filename1.htm

Processa
Pharmaceuticals, Inc.

7380
Coca Cola Drive, Suite 106

Hanover,
Maryland 21076

May
24, 2024

VIA
EDGAR Correspondence

United
States Securities and Exchange Commission

Division
of Corporation Finance

100
F. Street, N.E.

Washington,
D.C. 20549

Attn:
Ms. Jessica Dickerson

    Re:
    Acceleration
    of Effective Date

    Processa
    Pharmaceuticals, Inc.

    Registration
    Statement on Form S-3 (File No. 333-279588)

Ladies
and Gentlemen:

Pursuant
to Rule 461 under the Securities Act of 1933, as amended (the “Securities Act”), Processa Pharmaceuticals, Inc. (the “Registrant”),
hereby requests that the effective date of the above-referenced Registration Statement (the “Registration Statement”), be
accelerated so that the Registration Statement becomes effective under the Securities Act by 4:30 p.m., Eastern Time, on May 28, 2024,
or as soon thereafter as practicable.

The
Registrant respectfully requests that you notify Mr. Michael Kirwan of Foley & Lardner LLP of such effectiveness by a telephone call
to (904) 633-8913.

    Very
    truly yours,

    Processa
    Pharmaceuticals, Inc.

    By:
    /s/
    George Ng

    George
    Ng

    Chief
    Executive Officer

United States securities and exchange commission logo
May 23, 2024
George Ng
Chief Executive Officer
Processa Pharmaceuticals, Inc.
7380 Coca Cola Drive, Suite 106
Hanover, MD 21076
Re:Processa Pharmaceuticals, Inc.
Registration Statement on Form S-3
Filed May 21, 2024
File No. 333-279588
Dear George Ng:
            This is to advise you that we have not reviewed and will not review your registration
statement.
            Please refer to Rules 460 and 461 regarding requests for acceleration. 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.
            Please contact Jessica Dickerson at 202-551-8013 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       Michael B. Kirwan, Esq.

CORRESP
1
filename1.htm

January
22, 2024

VIA
FACSIMILE AND EDGAR

U.S.
Securities and Exchange Commission

Division
of Corporate Finance

Washington,
DC 20549

    Re:
    Processa
    Pharmaceuticals, Inc.

    Registration
    Statement on Form S-1 (Registration No. 333-276308) -

    Concurrence
    in Acceleration Request

Ladies
and Gentlemen:

H.C.
Wainwright & Co., LLC (“Wainwright”), solely acting as placement agent on a best-efforts basis in an offering
pursuant to the registration statement on Form S-1 (333-276308) (the “Registration Statement”), hereby concurs in
the request by Processa Pharmaceuticals, Inc. that the effective date of the above-referenced registration statement be accelerated to
5:15 P.M. Eastern Time on Wednesday, January 24, 2024, or as soon as practicable thereafter, pursuant to Rule 461 under the Securities
Act. Wainwright affirms that it is aware of its obligations under the Securities Act as they pertain to the best efforts offering pursuant
to the Registration Statement.

    Very
    truly yours,

    H.C.
    WAINWRIGHT & CO., LLC

    By:
    /s/
    Edward D. Silvera

    Name:
    Edward
    D. Silvera

    Title:
    Chief
    Operating Officer

430
Park Avenue | New York, NY 10022 | 212.356.0500 | www.hcwco.com

Member:
FINRA/SIPC

CORRESP
1
filename1.htm

7380
Coca Cola Drive, Suite 106

Hanover,
Maryland 21076

January
22, 2024

VIA
EDGAR

United
States Securities and Exchange Commission

Division
of Corporation Finance

100
F Street, NE

Washington,
D.C. 20549

Attention:
Mr. Jason Drory

    Re:

    Processa
    Pharmaceuticals, Inc.

    Registration
    Statement on Form S-1 (Registration No. 333-276308)

Ladies
and Gentlemen:

Pursuant
to Rule 461 under the Securities Act of 1933, as amended, the undersigned registrant, Processa Pharmaceuticals, Inc. (the “Registrant”),
hereby requests acceleration of effectiveness of its above-referenced Registration Statement to 5:15 P.M., Eastern time, on January 24,
2024, or as soon as practicable thereafter. The Registrant respectfully requests that you notify Mr. Michael Kirwan of Foley & Lardner
LLP of such effectiveness by a telephone call to (904) 633-8913.

    Very truly yours,

    Processa Pharmaceuticals, Inc.

    By:

    /s/
    George Ng

    George
    Ng

    Chief
    Executive Officer

United States securities and exchange commission logo
January 5, 2024
George Ng
Chief Executive Officer
Processa Pharmaceuticals, Inc.
7380 Coca Cola Drive, Suite 106
Hanover, MD 21076
Processa Pharmaceuticals, Inc.
Re:Processa Pharmaceuticals, Inc.
Registration Statement on Form S-1
Filed December 29, 2023
File No. 333-276308
Dear George Ng:
            This is to advise you that we have not reviewed and will not review your registration
statement.
            Please refer to Rules 460 and 461 regarding requests for acceleration. 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.
            Please contact Jason Drory at 202-551-8342 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       Michael Kirwan

United States securities and exchange commission logo
July 6, 2021
David Young, Pharm.D., Ph.D.
Chief Executive Officer
Processa Pharmaceuticals, Inc.
7380 Coca Cola Drive, Suite 106
Hanover, MD 21076
Re:Processa Pharmaceuticals, Inc.
Registration Statement on Form S-3
Filed June 30, 2021
File No. 333-257558
Dear Dr. Young:
            This is to advise you that we have not reviewed and will not review your registration
statement.
            Please refer to Rules 460 and 461 regarding requests for acceleration.  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.
            Please contact Christine Westbrook at 202-551-5019 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       John J. Wolfel, Esq.

CORRESP
1
filename1.htm

Processa
Pharmaceuticals, Inc.

7380
Coca Cola Drive, Suite 106

Hanover,
Maryland 21076

July
6, 2021

VIA
EDGAR

United
States Securities and Exchange Commission

Division
of Corporation Finance

100
F Street, NE

Washington,
D.C. 20549

Attention:
Ms. Christine Westbrook

    Re:
    Processa
    Pharmaceuticals, Inc.

    Registration
    Statement on Form S-3 (Registration No. 333-257558)

Ladies
and Gentlemen:

Pursuant
to Rule 461 under the Securities Act of 1933, as amended, the undersigned registrant, Processa Pharmaceuticals, Inc. (the “Registrant”),
hereby requests acceleration of effectiveness of its above-referenced Registration Statement to 12:00 P.M., Eastern time, on July 9,
2021, or as soon as practicable thereafter. For purposes of Rules 460 and 461, there is no underwriter. The Registrant respectfully requests
that you notify Mr. John Wolfel of Foley & Lardner LLP of such effectiveness by a telephone call to (904) 359-8778.

    Very
    truly yours,

    Processa
    Pharmaceuticals, Inc.

    By:
    /s/
    James Stanker

    James
    Stanker

    Chief
    Financial Officer

CORRESP
1
filename1.htm

Processa
Pharmaceuticals, Inc.

7380
Coca Cola Drive, Suite 106,

Hanover,
Maryland 21076

April
7, 2021

VIA
EDGAR

United
States Securities and Exchange Commission

Division
of Corporation Finance

100
F Street, NE

Washington,
D.C. 20549

Attention:
Ms. Christine Westbrook

    Re:
    Processa
    Pharmaceuticals, Inc.

    Registration
    Statement on Form S-3 (Registration No. 333-254983)

Ladies
and Gentlemen:

Pursuant
to Rule 461 under the Securities Act of 1933, as amended, the undersigned registrant, Processa Pharmaceuticals, Inc. (the “Registrant”),
hereby requests acceleration of effectiveness of its above-referenced Registration Statement to 12:00 P.M., Eastern time, on April
12, 2021, or as soon as practicable thereafter. For purposes of Rules 460 and 461, there is no underwriter. The Registrant respectfully
requests that you notify Mr. John Wolfel of Foley & Lardner LLP of such effectiveness by a telephone call to (904) 359-8778.

    Very
    truly yours,

    Processa
    Pharmaceuticals, Inc.

    By:
    /s/
    James Stanker

    James
    Stanker

    Chief
    Financial Officer

United States securities and exchange commission logo
April 5, 2021
David Young, Pharm.D, Ph. D.
Chairman and Chief Executive Officer
Processa Pharmaceuticals, Inc.
7380 Coca Cola Drive, Suite 106
Hanover, MD 21076
Re:Processa Pharmaceuticals, Inc.
Registration Statement on Form S-3
Filed April 2, 2021
File No. 333-254983
Dear Dr. Young:
            This is to advise you that we have not reviewed and will not review your registration
statement.
            Please refer to Rules 460 and 461 regarding requests for acceleration.  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.
            Please contact Christine Westbrook at 202-551-5019 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       John J. Wolfel, Esq.

CORRESP
1
filename1.htm

Processa
Pharmaceuticals, Inc.

7380
Coca Cola Drive, Suite 106,

Hanover,
Maryland 21076

September
29, 2020

VIA
EDGAR

United
States Securities and Exchange Commission

Division
of Corporation Finance

100
F Street, N.E.

Washington,
D.C. 20549

Attention:
Mr. Tim Buchmiller

    Re:
    Processa
    Pharmaceuticals, Inc.

    Registration
    Statement on Form S-1 (Registration No. 333-235511)

Ladies
and Gentlemen:

Pursuant
to Rule 461 under the Securities Act of 1933, as amended, the undersigned registrant, Processa Pharmaceuticals, Inc. (the “Registrant”),
hereby requests acceleration of effectiveness of its above-referenced Registration Statement to 4:30 P.M., Eastern time, on October
1, 2020, or as soon as practicable thereafter. The Registrant respectfully requests that you notify Michael Kirwan of Foley &
Lardner LLP of such effectiveness by a telephone call to (904) 633-8913.

    Very
    truly yours,

    Processa
    Pharmaceuticals, Inc.

    By:
    /s/
    David Young

    David
    Young, Pharm.D., Ph.D.

    Chief
    Executive Officer

CORRESP
1
filename1.htm

September
29, 2020

VIA
EDGAR

U.S.
Securities and Exchange Commission

Division
of Corporation Finance

100
F Street, N.E.

Washington,
D.C. 20549

    Re:
    Processa
    Pharmaceuticals, Inc. (the “Registrant”)

    Registration
    Statement on Form S-1, as amended (File No. 333-235511)

Ladies
and Gentlemen:

As
the representatives of the several underwriters of the Registrant’s proposed public offering of up to $20,892,625 of shares
of common stock, par value $0.0001 per share, we hereby join the Registrant’s request that the effective date of the above-referenced
Registration Statement on Form S-1 be accelerated so that it will be declared effective at 4:30 p.m. Eastern Time on October 1,
2020, or as soon thereafter as is practicable.

Pursuant
to Rule 460 of the Securities Act of 1933, as amended, we wish to advise you that we have effected the distribution of approximately
400 copies of the Registrant’s Preliminary Prospectus, dated September 16, 2020, through the date hereof, to prospective
underwriters, institutional investors, dealers and others.

The
undersigned advises that it has complied and will continue to comply, and that it has been informed by the participating underwriters
and dealers that they have complied with and will continue to comply, with the requirements of Rule 15c2-8 under the Securities
Exchange Act of 1934, as amended, in connection with the proposed public offering.

[Remainder
of page intentionally left blank.]

    Very
    truly yours,

    CRAIG-HALLUM
    CAPITAL GROUP LLC

    As
    Representative of the several Underwriters

    By:
    /s/
    Rick Hartfiel

    Name:
    Rick
    Hartfiel

    Title:
    Head
    of Investment Banking

    BENCHMARK
    COMPANY, LLC

    As
    Representative of the several Underwriters

    By:
    /s/
    John J. Borer III

    Name:
    John
    J. Borer III

    Title:
    Senior
    Managing Director

Signature
Page to Acceleration Request

CORRESP
1
filename1.htm

Processa
Pharmaceuticals, Inc.

7380
Coca Cola Drive, Suite 106,

Hanover,
Maryland 21076

September
25, 2020

VIA
EDGAR

United
States Securities and Exchange Commission

Division
of Corporation Finance

100
F Street, NE

Washington,
D.C. 20549

Attention:
Mr. Tim Buchmiller

    Re:
    Processa
    Pharmaceuticals, Inc.

    Registration
    Statement on Form S-1 (Registration No. 333-235511)

Ladies
and Gentlemen:

Reference
is made to our letter to you dated September 22, 2020 (the “Acceleration Request”) to request that the Processa Pharmaceuticals,
Inc. Registration Statement on Form S-1 (Registration No. 333-235511) be declared effective at 4:30 p.m., Eastern time, on September
24, 2020, or as soon as practicable thereafter. We now respectfully withdraw the Acceleration Request.

The
Registrant respectfully requests that you contact Michael Kirwan of Foley & Lardner LLP by telephone call to (904) 633-8913
with any questions or requests for additional information.

    Very
    truly yours,

    Processa
    Pharmaceuticals, Inc.

    By:
    /s/
    David Young

    David
Young, Pharm.D., Ph.D.

    Chief
Executive Officer

CORRESP
1
filename1.htm

Processa
Pharmaceuticals, Inc.

7380
Coca Cola Drive, Suite 106,

Hanover,
Maryland 21076

September
22, 2020

VIA
EDGAR

United
States Securities and Exchange Commission

Division
of Corporation Finance

100
F Street, N.E.

Washington,
D.C. 20549

Attention:
Mr. Tim Buchmiller

    Re:
    Processa
    Pharmaceuticals, Inc.

    Registration
    Statement on Form S-1 (Registration No. 333-235511)

Ladies
and Gentlemen:

Pursuant
to Rule 461 under the Securities Act of 1933, as amended, the undersigned registrant, Processa Pharmaceuticals, Inc. (the “Registrant”),
hereby requests acceleration of effectiveness of its above-referenced Registration Statement to 4:30 P.M., Eastern time, on September
24, 2020, or as soon as practicable thereafter. The Registrant respectfully requests that you notify Michael Kirwan of Foley &
Lardner LLP of such effectiveness by a telephone call to (904) 633-8913.

    Very truly yours,

    Processa Pharmaceuticals, Inc.

    By:
    /s/
    David Young

    David
    Young, Pharm.D., Ph.D.

    Chief
    Executive Officer

CORRESP
1
filename1.htm

September
22, 2020

VIA
EDGAR

U.S.
Securities and Exchange Commission

Division
of Corporation Finance

100
F Street, N.E.

Washington,
D.C. 20549

    Re:
    Processa
    Pharmaceuticals, Inc. (the “Registrant”)

    Registration
    Statement on Form S-1, as amended (File No. 333-235511)

Ladies
and Gentlemen:

As
the representatives of the several underwriters of the Registrant’s proposed public offering of up to $20,892,625 of shares
of common stock, par value $0.0001 per share, we hereby join the Registrant’s request that the effective date of the above-referenced
Registration Statement on Form S-1 be accelerated so that it will be declared effective at 4:30 p.m. Eastern Time on September
24, 2020, or as soon thereafter as is practicable.

Pursuant
to Rule 460 of the Securities Act of 1933, as amended, we wish to advise you that we have effected the distribution of approximately
400 copies of the Registrant’s Preliminary Prospectus, dated September 16, 2020, through the date hereof, to prospective
underwriters, institutional investors, dealers and others.

The
undersigned advises that it has complied and will continue to comply, and that it has been informed by the participating underwriters
and dealers that they have complied with and will continue to comply, with the requirements of Rule 15c2-8 under the Securities
Exchange Act of 1934, as amended, in connection with the proposed public offering.

[Remainder
of page intentionally left blank.]

    Very
    truly yours,

    CRAIG-HALLUM
    CAPITAL GROUP LLC

    As
    Representative of the several Underwriters

    By:
    /s/ Rick Hartfiel

    Name:
    Rick Hartfiel

    Title:
    Head of Investment Banking

    BENCHMARK
    COMPANY, LLC

    As
    Representative of the several Underwriters

    By:
    /s/ John J. Borer III

    Name:
    John J. Borer III

    Title:
    Senior Managing Director

Signature Page to Acceleration Request

December 17, 2019
David Young, Pharm.D, Ph.D.
Chairman and Chief Executive Officer
Processa Pharmaceuticals, Inc.
7380 Coca Cola Drive, Suite 106
Hanover, Maryland 21076
Re:Processa Pharmaceuticals, Inc.
Registration Statement on Form S-1
Filed December 13, 2019
File No. 333-235511
Dear Dr. Young:
            This is to advise you that we have not reviewed and will not review your registration
statement.
            Please refer to Rules 460 and 461 regarding requests for acceleration.  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.
            Please contact Tim Buchmiller at (202) 551-3635 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       Michael B. Kirwan, Esq.

CORRESP
1
filename1.htm

Processa
Pharmaceuticals, Inc.

7380
Coca Cola Drive, Suite 106,

Hanover,
Maryland 21076

November
7, 2018

VIA
EDGAR

United
States Securities and Exchange Commission

Division
of Corporation Finance

100
F Street, NE

Washington,
D.C. 20549

Attention:
Ms. Dorrie Yale

    Re:
    Processa
    Pharmaceuticals, Inc.

    Registration
    Statement on Form S-1 (Registration No. 333-226428)

Ladies
and Gentlemen:

Pursuant
to Rule 461 under the Securities Act of 1933, as amended, the undersigned registrant, Processa Pharmaceuticals, Inc. (the “Registrant”),
hereby requests acceleration of effectiveness of its above-referenced Registration Statement to 4:30 P.M., Eastern time, on November
9, 2018, or as soon as practicable thereafter. The Registrant respectfully requests that you notify Neda Sharifi of Foley &
Lardner LLP of such effectiveness by a telephone call to (904) 359-8719.

    Very truly yours,

    Processa Pharmaceuticals, Inc.

    By:

    /s/
    David Young

     David
    Young, Pharm.D., Ph.D.

     Chief
    Executive Officer

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

October
30, 2018

Via
EDGAR

United
States Securities and Exchange Commission

Division
of Corporation Finance

Office
of Healthcare & Insurance

Washington,
D.C. 20549

 Re: Processa
                                         Pharmaceuticals, Inc.

                                         Amendment No. 2 to Registration Statement on Form S-1

                                         Filed October 9, 2018

                                         File No. 333-226428

Dear
Sir or Madaam,

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 of the United States Securities and Exchange Commission set forth in your letter
to Dr. David Young, Processa’s Chief Executive Officer, dated October 24, 2018. Your comments are reproduced below in bold,
followed in each case by our response on behalf of the Company.

Amendment
No. 2 to Form S-1

Description
of Business, page 37

1. We
                                         note your revised disclosures in response to prior comment 3. However, please further
                                         clarify your disclosure to explain how you identified RIF in head and neck cancer patients
                                         as an indication to treat with PCS-499 by expanding the ninth paragraph on page 37.

Response

The
Company has expanded Description of Business to further clarify how the Company identified RIF in head and neck cancer
patients as an indication to treat with PCS-499.

    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

October
30, 2018

Page
2

2. We
                                         note your revised disclosure in response to prior comment 4 regarding the prior trials.
                                         Your revised disclosure describes five prior trials, but you state in the ninth paragraph
                                         on page 37 that there were six clinical trials, including two studies in patients with
                                         chronic kidney disease. Please reconcile your disclosures or revise to add similar disclosure
                                         regarding this prior trial. Additionally, we refer to your statement regarding the most
                                         common adverse events associated with PCS-499 in the 11th paragraph on page 37. Please
                                         revise to disclose all serious adverse events, even if they were later determined not
                                         to be related to PCS-499.

Response

The
Company has revised Description of Business to discuss clearly all prior trials and their results. Furthermore, the Company
has expanded disclosure regarding all serious adverse events which were associated with the Phase 2 studies.

3. Please
                                         revise the second sentence in the 11th paragraph on page 37 to clarify the number of
                                         patients involved in the Phase 2 trial. Please also describe the primary and secondary
                                         endpoints in terms of their objective data points, and whether the endpoints were met.

Response

The
Company has revised Description of Business to clarify the number of patients included and has expanded the description
of the primary and secondary endpoints in terms of their objective data points and whether the endpoints were met.

If
you should have any additional questions, please contact me at (904) 633-8913.

    Sincerely,

    /s/
    Michael B. Kirwan

    Michael
    B. Kirwan

MBK:arm

    cc:
    Dr. David Young, Chief Executive Officer

    John
    J. Wolfel, Esq.

    Neda A. Sharifi, Ph.D., Esq.

October 24, 2018
David Young
Chief Executive Officer
Processa Pharmaceuticals, Inc.
7380 Coca Cola Drive, Suite 106
Hanover, MD 21076
Re:Processa Pharmaceuticals, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2017
Filed April 16, 2018 (as amended on April 17, 2018)
Form 10-Q for the Quarterly Period Ended March 31, 2018
Filed May 21, 2018
File No. 333-184948
Dear Dr. Young:
            We have completed our review of your filings.  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.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
cc:       Neda A. Sharifi

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

October
9, 2018

Via
EDGAR

    United
        States Securities and Exchange Commission

        Division
        of Corporate Finance

        Washington,
        D.C. 20549

    Re:
    Processa
    Pharmaceuticals, Inc.

    Amendment
    No. 1 to Registration Statement on Form S-1

    Filed
    September 14, 2018

    File
    No. 333-226428

Dear
Sir or Madaam,

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 of the United States Securities and Exchange Commission set forth in your letter
to Dr. David Young, Processa’s Chief Executive Officer, dated September 28, 2018. Your comments are reproduced below in
bold, followed in each case by our response on behalf of the Company.

Amendment
No. 1 to Registration Statement on Form S-1

Prospectus
Summary, page 1

    1.
    We
    acknowledge your response to prior comment 3. As noted in the prior comment, please also disclose when PTX was approved, the
    indication for which it was approved, and the fact that it was approved by the FDA.

Response

The
Company has now added the requested information about PTX to the Prospectus Summary and the Description of Business.

    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

October
9, 2018

Page
2

Liquidity
and Capital Resources, page 30

    2.
    We
    note your disclosure that you anticipate needing an additional $900,000 to continue planned operations through the fourth
    quarter of 2019. Please also disclose how long you expect your business operations to continue should you not be able to secure
    the additional $900,000.

Response

The
Company has updated Liquidity and Capital Resources to reflect how long it expects its business operations to continue
without additional funding.

Description
of Business, page 37

    3.
    We
    acknowledge your revised disclosures in response to prior comment 15. As referenced in the prior comment, please further expand
    your revised disclosure to explain how you identified Radiation-Induced Fibrosis (RIF) in head and neck cancer patients as
    an indication for which PCS-499 may result in clinical efficacy.

Response

The
Company has revised Description of Business to address why PCS-499 may result in clinical efficiency for RIF.

    4.
    We
    acknowledge your revised disclosure in response to prior comment 16 and that you acquired prior clinical data. As noted in
    the prior comment, please expand your disclosure to discuss specific trial results for your product candidate on which you
    intend to rely, including the duration of the trials, 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 has revised Description of Business to expand upon the discussion of prior trials and the results that we are relying
on.

October
9, 2018

Page
3

Intellectual
Property, page 38

    5.
    Please
    further expand your revised disclosure to clarify the type of patent protection that you have for your issued patents (as
    compared to your patent applications), and identify all of the foreign jurisdictions in which you have patents or patent applications.

Response

The
Company has expanded its disclosure of patents in Intellectual Property to clarify the type of patent protection and better
identify foreign jurisdictions where the Company has patents or patent applications.

License
Agreement with CoNCERT Pharmaceuticals, Inc., page 38

    6.
    We
    note your response to prior comment 17. Please explain how the board observer rights expired as it does not appear that the
    amendment to the license agreement amended the provision.

Response

Section
2.6 of the Option and License Agreement with CoNCERT Pharmaceuticals, Inc. dated October 4, 2017 provides that the right to a
board observer seat expires when CoNCERT Pharmaceuticals, Inc.’s ownership interest in Promet first decreases below ten
percent (10%) of Promet’s outstanding voting stock. The March 19, 2018 amendment provides that the Company agrees to be
bound by the terms to the same extent as Promet. CoNCERT Pharmaceuticals, Inc. now owns less than six percent (6%) of the Company’s
outstanding voting stock.

Directors,
Executive Officers, Promoters and Control Persons, page 43

    7.
    We
    refer to your disclosure regarding your newly appointed CFO. Please clarify whether Mr. Stanker’s employment and experience
    at Grant Thornton is during the past five years. If not, please disclose his principal occupations during such period. Refer
    to Item 401(e)(1) of Regulation S-K.

Response

Mr.
Stanker’s employment and experience at Grant Thorton did occur during the past five years. The Company has revised the description
of Mr. Stanker to clarify this point.

October
9, 2018

Page
4

Plan
of Distribution, page 57

    8.
    We
    acknowledge your response to prior comment 24. Please note that to the extent you expect to seek effectiveness of the registration
    statement prior to the filing of your agreement with PoC Capital in an upcoming Exchange Act report, please file this agreement
    as an exhibit to the registration statement.

Response

The
pledge agreement with PoC Capital dated May 25, 2018 has now been filed as Exhibit 10.14 to the registration statement.

Financial
Statements

Notes
to Condensed Consolidated Financial Statements

Note
2 - Intangible Asset, page F-38

    9.
    In
    your response to prior comment 25 you indicate that the reverse merger transaction between Processa Pharmaceuticals (formerly
    Heatwurx Inc.) and Promet Therapeutics was considered an IRC Section 351 tax-free contribution of assets by Promet solely
    for over 80% of the voting stock of Processa. You also indicate that included in the Contributed Assets were all rights, title
    and interest under a certain option and license agreement with CoNCERT Pharmaceuticals with respect to certain know-how, patent
    rights and compounds. Please address the following:

    ●
    Revise
    your disclosures describing the reverse merger transaction to clarify that this transaction was treated as a tax-free contribution
    under IRC Section 351.

Response

The
Company has revised its disclosures in Note 1 – Organizations and Summary of Significant Accounting Policies on pages
F-7 and F-33 to indicate the reverse merger transaction was accounted for as a tax-free contribution under Internal Revenue
Code Section 351. The Company also revised Note 5 – Income Taxes on page F-42 to clarify that the contributed
assets under the option and license agreement with CoNCERT Pharmaceuticals, Inc. for which voting shares of the Company were expressly
contemplated to be issued as part and parcel with, and integrated into, the IRC Section 351 transaction because all the contributed
assets, include the CoNCERT assets, were contemplated to be integral to each other and were considered to be an integrated undertaking
as the primary target, purpose and reason for the overall transaction.

October
9, 2018

Page
5

The
Company will include the revised disclosures in future filings.

    ●
    Confirm
    for us, if true, that as part of the reverse merger transaction in October 2017 you acquired an option to acquire a license
    from CoNCERT and that this option was subsequently exercised in March 2018. If so, explain how you determined that the subsequent
    exercise of this option should be considered as part of the initial Section 351 transaction. Provide us with any documentation
    to support your accounting treatment.

Response

Pursuant to a request for confidential
treatment, we have separately furnished the Company’s Board Consent from September 2017 contemporaneously identifying the
Section 351 transaction and the intended components of such transaction (the “2017 Consent”). While contemplated
as part of the reverse merger, the option to acquire the license from CoNCERT was not transferred by Promet to Processa until
the conditions to the option’s exercise were satisfied and accepted by CoNCERT in March 2018.

As
reflected in the 2017 Consent, the subsequent option exercise and release of stock to CoNCERT for the IP licensed in the transaction
was known of, intended and considered so integral to the overall transaction and plan that the companies and their respective
advisors included it in the transaction as part of the overall section 351 plan. Further, Section 351 provides that transactions
need not be simultaneous to qualify, as long as a plan is in place. Reg. 1.351-1(a) states: “The phrase ‘immediately
after the exchange’ does not necessarily require simultaneous exchanges by two or more persons, but comprehends a situation
where the rights of the parties have been previously defined and the execution of the agreement proceeds with an expedition consistent
with orderly procedure.” The CoNCERT transaction was closed as soon as could be closed after the October 2017 transaction.

In
March 2018, the Company estimated the fair value of the intangible asset as approximately $11 million (consisting of $8 million,
based on the fair value of the 2,090,301 shares of common stock issued to CoNCERT (an unrelated party) and $3 million due to recording
an offsetting deferred tax liability). The Company also determined the expected life of the intangible asset to be 14 years.

    ●
    For
    impairment purposes, tell us how you determined that the carrying amount of this intangible asset (which includes the $3m
    in capitalized costs) was recoverable as of June 30, 2018.

October
9, 2018

Page
6

Response

ASC
360-10 provides that intangible assets with finite lives be reviewed for impairment when facts and circumstances indicate that
the carrying value of the asset may not be recoverable. In the Company’s evaluation of its intangible assets, it considers
the term of the underlying asset life and the expected life of the related product line. If impairment indicators are present
or changes in circumstance suggest that impairment may exist, the Company would perform a recoverability test by comparing the
sum of the estimated undiscounted cash flows of each intangible asset to its carrying value on the consolidated balance sheet.
If the undiscounted cash flows used in the recoverability test are less than the carrying value, the Company would determine the
fair value of the intangible asset and recognize an impairment loss in the statement of operations if the carrying value of the
intangible asset exceeds its fair value. Events that could result in an impairment, or trigger an interim impairment assessment,
may include actions by regulatory authorities with respect to us or our competitors, new or better products entering the market,
changes in market share or market pricing, changes in the economic lives of the assets, changes in the legal framework covering
patents, rights or licenses, and other market changes which could have a negative effect on cash flows and which could result
in an impairment.

The
Company’s development of PCS 499 is progressing in accordance with the Company’s expectations, both from a technical
and market perspective and are in accordance with the Company’s budget. The Company did not identify any indication of impairment
or any other significant adverse change related to the asset that would impact its recoverability. To the contrary, several positive
events have recently occurred, including: on June 22, 2018, the U.S. Food and Drug Administration (“FDA”) granted
orphan-drug to the Company’s leading clinical compound PCS-499 for treatment in Necrobiosis Lipoidica (“NL”);
on August 29, 2018, the Company submitted to the FDA an Investigational New Drug (IND) application (“IND”) for PCS-499
in NL with the plan to initiate a Phase 2 study in NL patients in 2018; and on October 2, 2018, the Company announced that the
FDA granted the Company clearance to proceed with a Phase 2 clinical trial of PCS-499 in patients with NL under the recently submitted
IND application.

If
you should have any additional questions, please contact me at (904) 633-8913.

    Sincerely,

    /s/
    Michael B. Kirwan

    Michael
    B. Kirwan

    MBK:arm

    cc:
    Dr.
    David Young, Chief Executive Officer

    John
    J. Wolfel, Esq.

    Neda
    A. Sharifi, Ph.D., Esq.

September 28, 2018
David Young
Chief Executive Officer
Processa Pharmaceuticals, Inc.
7380 Coca Cola Drive, Suite 106
Hanover, MD 21076
Re:Processa Pharmaceuticals, Inc.
Amendment No. 1 to Registration Statement on Form S-1
Filed September 14, 2018
File No. 333-226428
Dear Dr. Young:
            We have reviewed your amended registration statement 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 this letter by amending your registration statement and providing the
requested information.  If you do not believe our comments apply to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
            After reviewing any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments.  Unless we note
otherwise, our references to prior comments are to comments in our August 28, 2018 letter.
Amendment No. 1 to Registration Statement on Form S-1
Prospectus Summary, page 1
1.We acknowledge your response to prior comment 3.  As noted in the prior comment,
please also disclose when PTX was approved, the indication for which it was approved,
and the fact that it was approved by the FDA.
Liquidity and Capital Resources, page 30
2.We note your disclosure that you anticipate needing an additional $900,000 to continue
planned operations through the fourth quarter of 2019.  Please also disclose how long you

 FirstName LastNameDavid Young
 Comapany NameProcessa Pharmaceuticals, Inc.
 September 28, 2018 Page 2
 FirstName LastNameDavid Young
Processa Pharmaceuticals, Inc.
September 28, 2018
Page 2
expect your business operations to continue should you not be able to secure the
additional $900,000.
Description of Business, page 37
3.We acknowledge your revised disclosures in response to prior comment 15.  As
referenced in the prior comment, please further expand your revised disclosure to explain
how you identified Radiation-Induced Fibrosis (RIF) in head and neck cancer patients as
an indication for which PCS-499 may result in clinical efficacy.
4.We acknowledge your revised disclosure in response to prior comment 16 and that you
acquired prior clinical data.  As noted in the prior comment, please expand your disclosure
to discuss specific trial results for your product candidate on which you intend to rely,
including the duration of the trials, 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.
Intellectual Property, page 38
5.Please further expand your revised disclosure to clarify the type of patent protection that
you have for your issued patents (as compared to your patent applications), and identify
all of the foreign jurisdictions in which you have patents or patent applications.
License Agreement with CoNCERT Pharmaceuticals, Inc., page 38
6.We note your response to prior comment 17.  Please explain how the board observer
rights expired as it does not appear that the amendment to the license agreement amended
the provision.
Directors, Executive Officers, Promoters and Control Persons, page 43
7.We refer to your disclosure regarding your newly appointed CFO.  Please clarify whether
Mr. Stanker's employment and experience at Grant Thornton is during the past five years.
If not, please disclose his principal occupations during such period.  Refer to Item
401(e)(1) of Regulation S-K.
Plan of Distribution, page 57
8.We acknowledge your response to prior comment 24.  Please note that to the extent you
expect to seek effectiveness of the registration statement prior to the filing of your
agreement with PoC Capital in an upcoming Exchange Act report, please file this
agreement as an exhibit to the registration statement.

 FirstName LastNameDavid Young
 Comapany NameProcessa Pharmaceuticals, Inc.
 September 28, 2018 Page 3
 FirstName LastName
David Young
Processa Pharmaceuticals, Inc.
September 28, 2018
Page 3
Financial Statements
Notes to Condensed Consolidated Financial Statements
Note 2 - Intangible Asset, page F-38
9.In your response to prior comment 25 you indicate that the reverse merger transaction
between Processa Pharmaceuticals (formerly Heatwurx Inc.) and Promet Therapeutics
was considered an IRC Section 351 tax-free contribution of assets by Promet solely for
over 80% of the voting stock of Processa.  You also indicate that included in the
Contributed Assets were all rights, title and interest under a certain option and license
agreement with CoNCERT Pharmaceuticals with respect to certain know-how, patent
rights and compounds.  Please address the following:

•Revise your disclosures describing the reverse merger transaction to clarify that this
transaction was treated as a tax-free contribution under IRC Section 351.
•Confirm for us, if true, that as part of the reverse merger transaction in October 2017
you acquired an option to acquire a license from CoNCERT and that this option was
subsequently exercised in March 2018.  If so, explain how you determined that the
subsequent exercise of this option should be considered as part of the initial Section
351 transaction.  Provide us with any documentation to support your accounting
treatment.
•For impairment purposes, tell us how you determined that the carrying amount of this
intangible asset (which includes the $3m in capitalized costs) was recoverable as of
June 30, 2018.
            You may contact Andi Carpenter at 202-551-3645 or Angela Connell at 202-551-3426 if
you have questions regarding comments on the financial statements and related matters.  Please
contact Dorrie Yale at 202-551-8776 or Ada Sarmento at 202-551-3798 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
cc:       Neda Sharifi

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

Office
of Healthcare and Insurance

Washington,
D.C. 20549

    Re:
    Processa
    Pharmaceuticals, Inc.

    Form
    10-K for the Fiscal Year Ended December 31, 2017

    Filed
    April 16, 2018 (as amended on April 17, 2018)

    Form
    10-Q for the Quarterly Period Ended March 31, 2018 Filed May 21, 2018

    File
    No. 333-184948

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.

Annual
Report on Form 10-K/A

Item
1. Business, page 3

    1.
    Please
    expand your disclosure to explain how you identified NL and RIF in head and neck cancer patients as indications for which
    PCS-499 may result in clinical efficacy. Please also explain in terms a lay reader would understand what you mean that your
    product candidate is an “analog of an active metabolite,” and disclose the drug that is already approved, the
    indication for which it was approved, and clarify whether it was approved by the FDA or another regulatory authority.

    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

 Response

In
future filings, the Company will expand its disclosure to (1) 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,
(2) disclose the name and approved indications of the FDA approved analog and (3) 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.

    2.
    We
    note your statements 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 confirm that in future filings, you will revise your disclosures
    to remove all references about your product candidate’s safety and efficacy, including statements regarding preliminary
    indications of efficacy (whether for your planned indication or other indications).

 Response

In
future filings, the Company will revise its disclosure to remove all references to PCS-499 as being effective, including removal
of references to preliminary indications of efficacy. Furthermore, the Company will make similar revisions regarding the safety
of PCS-499.

    3.
    We
    refer to your statement that your business strategy is to identify drugs that can be “quickly” developed within
    “2-4 years.” Please expand your disclosure to discuss the regulatory pathways you intend to pursue for your lead
    and other product candidates and their requirements. If you intend to rely on studies of third parties in seeking approval
    for PCS-499, identify the parties who performed the studies.

Response

In
future filings, the Company will expand the description of its business model to explain the justification for identification
of drugs that can be quickly developed within 2-4 years.

Intellectual
Property, page 4

    4.
    Please
    revise your disclosure to discuss the patents you have licensed relating to your product candidate, including the jurisdiction,
    the type of patent protection (e.g., composition of matter, use, or process), and the patent expiration dates.

September
14, 2018

Page
3

 Response

In
future filings, the Company will expand its intellectual property disclosure to include the quantity, jurisdiction, type and expiration
dates of its licensed patents.

Asset
Acquisitions by Licensing Agreements or Company Acquisitions, page 5

    5.
    Please
    revise this section to discuss the material terms of your CoNCERT agreement and any other material license or collaboration
    agreements you may have at the time, 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 68 concerning CoNCERT’s right to have one Board observer
    attend Promet’s Board meetings. If CoNCERT has that right with respect to Processa’s Board meetings, please discuss
    it here.

 Response

In
future filings, the Company will expand its disclosure to include the material terms of the Company’s license agreement
with CoNCERT Pharmaceuticals, Inc. Please note that CoNCERT Pharmaceuticals, Inc. does not have, and never has had, any board
observer rights with the Company as such rights expired upon the assignment of the license agreement from Promet to the Company.
The reference to board observer rights has been removed from the notes to the financial statements.

Item
1A. Risk Factors, page 9

    6.
    Please
    add a risk factor to discuss the material risks associated with the fact that you do not have an audit or compensation committee,
    and that (according to the disclosure in your Registration Statement on Form S-1 filed on July 30, 2018) only one of your
    directors is independent.

 Response

In
future filings, to the extent still applicable, the Company will include a new risk factor to discuss that the Company does not
have an audit committee or compensation committee and that the Company does not 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 19

    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

In
future filings, the Company will expand its disclosure to specify the Company’s 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 26

    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

In
future filings, the Company will revise its disclosure to include the date and dollar value of the loss suffered by the Company
as a result of the cybersecurity breach.

Item
10. Directors, Executive Officers and Key Employees, page 73

    9.
    Please
    revise your disclosure to explain how Dr. Young helped Questcor transition from being nearly bankrupt to having a valuation
    of over $5 billion in his role as an independent director.

 Response

In
future filings, the Company will revise its disclosure to explain Dr. Young’s role as an independent director and subsequently
as the Chief Scientific Officer of Questcor in transitioning Questcor from nearly a bankrupt company to ultimately the sale of
the company for over $5 billion.

September
14, 2018

Page
5

Form
10-Q for the Quarterly Period Ended March 31, 2018

Notes
to Consolidated Financial Statements

Note
2 - Intangible Asset, page 12

    10.
    You
    disclose that the $11 million intangible asset recorded as of March 31, 2018 includes $3 million of costs capitalized to record
    an offset to a deferred tax liability related to the exercise of your option to acquire an exclusive license from CoNCERT
    related to patent rights and know-how to develop and commercialize compounds and products for CTP-499. You also disclose on
    page 15 that this deferred tax liability was created when CoNCERT sold its license and know-how to you for stock in a transaction
    under Section 351 of the Internal Revenue Code (Section 351 transaction) which treats the acquisition of the license and know-how
    as a tax-free exchange. Please provide us with a detailed analysis explaining how you determined that this transaction met
    the requirements to be considered a tax-free exchange under Section 351. In this regard, it would appear that under Section
    351 an exchange would be considered tax free if (a) the property was exchanged solely for stock of the company and (b) immediately
    after the exchange the transferor controlled the company via 80% or more ownership of voting stock. Based on your beneficial
    ownership table on page 49 of your Form S-1 filed on July 30, 2018, it appears that CoNCERT owns only 5.4% of your outstanding
    shares.

 Response

In
October 2017, Promet Therapeutics LLC., a Delaware limited liability company (“Promet”), and Processa Pharmaceuticals,
Inc., formerly known as Heatwurx Inc. (“Processa”) entered into an Asset Purchase Agreement (the “APA”),
pursuant to which Processa acquired, in an Internal Revenue Code Section 351 tax-free contribution of assets solely for over 80%
of the voting stock of Processa (the “Section 351 Transaction”) by Promet, all of the properties, rights and assets,
including liabilities and commitments, owned by Promet, directly or indirectly, in whole or in part, of every type and description,
real, personal or mixed, tangible and intangible, wherever located and whether or not reflected on the books of Promet (the “Contributed
Assets”, and the transaction as a whole the “Promet/Processa Transaction”).

Included
in the Contributed Assets, Promet also transferred and contributed all, rights, title and interest under a certain option and
license agreement with CoNCERT Pharmaceuticals, Inc. (“CoNCERT”) with respect to certain know-how, patent rights and
compounds developed or obtained by CoNCERT (the “CoNCERT Assets”) for which voting securities of Processa were expressly
contemplated to be issued as part and parcel with, and integrated into, the Section 351 transaction to CoNCERT because all Contributed
Assets including the CoNCERT Assets were contemplated to be integral to each other and were considered to be an integrated undertaking
as the primary target, purpose and reason for the overall transaction itself.

September
14, 2018

Page
6

The
APA was executed pursuant to authority granted by a “Unanimous Written Consent of the Board of Directors of Processa”
dated in September 2017 which demonstrates that both Promet and Processa contemplated and intended that the Asset Purchase and
the CoNCERT Assets were integral to one another and the recipients of equity, being Promet and CoNCERT, in connection therewith
will control the Corporation for purposes of Section 351 and Section 368(c) in that they will own (i) at least 80% of the total
combined voting power of all classes of stock entitled to vote and (ii) at least 80% of the total number of shares of all other
classes of stock of the corporation. The Unanimous Written Consent demonstrates the transfer of all of Promet’s assets,
including but not limited to the transfer of any and all rights relating to the CoNCERT’s Assets to Processa was meant to
be an integrated transaction for tax purposes.

The
Company structured, intended and expressly accepted that the transaction of Promet contributing its and the CoNCERT Assets solely
for stock qualified for Section 351 treatment given that at the conclusion of the events both Promet and CoNCERT controlled more
than 80% of the corporation immediately after the transactions were concluded. The 5.4% of the outstanding shares that were issued
to CoNCERT were part of the overall 90% of the shares (more than the 80% “control” percentage pursuant to Code Section
368(c)) of Processa voting stock acquired as part of an integrated Section 351 Transaction whereby Processa acquired the Contributed
Assets.

September
14, 2018

Page
7

If
you should have any additional questions, please contact me at (904) 633-8913.

    Sincerely,

    /s/
    Michael B. Kirwan

    Michael
    B. Kirwan

MBK:arm

    cc:
    Dr.
    David Young, Chief Executive Officer

    John
    J. Wolfel, Esq.

    Neda
    A. Sharifi, Ph.D., Esq.

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

August 28, 2018
David Young
Chief Executive Officer
Processa Pharmaceuticals, Inc.
7380 Coca Cola Drive, Suite 106
Hanover, MD 21076
Re:Processa Pharmaceuticals, Inc.
Registration Statement on Form S-1
Filed July 30, 2018
File No. 333-226428
Dear Dr. Young:
            We have reviewed your registration statement 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 this letter by amending your registration statement and providing the
requested information.  If you do not believe our comments apply to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
            After reviewing any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments.
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.

 FirstName LastNameDavid Young
 Comapany NameProcessa Pharmaceuticals, Inc.
 August 28, 2018 Page 2
 FirstName LastNameDavid Young
Processa Pharmaceuticals, Inc.
August 28, 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.
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.
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.
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.
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.
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.

 FirstName LastNameDavid Young
 Comapany NameProcessa Pharmaceuticals, Inc.
 August 28, 2018 Page 3
 FirstName LastNameDavid Young
Processa Pharmaceuticals, Inc.
August 28, 2018
Page 3
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.
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.
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.
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.
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.
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 evidenice is
"anecdotal."  Please revise this disclosure to explain how you would consider anecdotal
information 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.
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.
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

 FirstName LastNameDavid Young
 Comapany NameProcessa Pharmaceuticals, Inc.
 August 28, 2018 Page 4
 FirstName LastNameDavid Young
Processa Pharmaceuticals, Inc.
August 28, 2018
Page 4
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.
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.
Intellectual Property, page 38
18.Expand your disclosure to discuss the patents you have licensed relating to your product
candidate, including the jurisdiction, the type of patent protection (e.g., composition of
matter, use, or process), and the patent expiration dates.
Directors, Executive Officers, Promoters and Control Persons, page 43
19.Please revise to explain how Dr. Young helped Questcor transition from being nearly
bankrupt to having a valuation of over $5 billion in his role as an independent director or
remove this statement from his biography.
Corporate Governance, page 45
20.We note your statement here that Mr. Thompson is independent as defined by NASDAQ
Rule 5605, and your statement in your Annual Report on Form 10-K filed on April 2,
2018, as amended, that there were no independent directors on your board under this rule,
which would include Mr. Thompson.  Please explain what factors led to this change.
Security Ownership of Certain Beneficial Owners and Management, page 49
21.Please revise your disclosure to identify the natural person or persons who have voting
and investment control of the shares held by Promet Therapeutics, LLC, CorLyst, LLC
and CoNCERT Pharnaceuticals, Inc.  Please also confirm whether Dr. Young has voting
and investment control of the shares held by the Young-Plaisance Revoc Trust.
Transactions with Related Persons, Promoters and Certain Control Persons, page 50
22.We note your statement that Dr. Young is also the CEO and managing member of
CorLyst, LLC.  Please revise to clarify the percentage of time Dr. Young spends on your
business, and if the time spent on other businesses is not immaterial, please expand your
risk factor discussion to disclose this obligation.

 FirstName LastNameDavid Young
 Comapany NameProcessa Pharmaceuticals, Inc.
 August 28, 2018 Page 5
 FirstName LastNameDavid Young
Processa Pharmaceuticals, Inc.
August 28, 2018
Page 5
The Selling Stockholders, page 55
23.Revise your table to also include information relating to the percentage to be owned by
security holders after completion of the offering to the extent such percentage is 1% or
more.  In addition, please disclose the relationship you have with PoC Capital, LLC,
which appears to be the investor who is committed to fund up to $1.8 million of your
clinical trial expenses.  Refer to Item 507 of Regulation S-K.
Plan of Distribution, page 57
24.We refer to your statement that any pledgee of each selling stockholder may sell the
shares covered by the registration statement, and we note that under your agreement with
PoC Capital, PoC has pledged to you as collateral 50% of its securities received from its
investment.  If true, please revise to clarify the exclusion of these pledged securities from
your statement.  In addition, please tell us when the securities will be released from the
pledge, and file your agreement with this investor as an exhibit to your registration
statement, including all exhibits thereto.
Financial Statements
Notes to Consolidated Financial Statements
Note 2 - Intangible Asset, page F-38
25.You disclose that the $11 million intangible asset recorded as of March 31, 2018 includes
$3 million of costs capitalized to record an offset to a deferred tax liability related to the
exercise of your option to acquire an exclusive license from CoNCERT related to patent
rights and know-how to develop and commercialize compounds and products for CTP-
499.  You also disclose on page F-41 that this deferred tax liability was created when
CoNCERT sold its license and know-how to you for stock in a transaction under Section
351 of the Internal Revenue Code (Section 351 transaction) which treats the acquisition of
the license and know-how as a tax-free exchange.  Please provide us with a detailed
analysis explaining how you determined that this transaction met the requirements to be
considered a tax-free exchange under Section 351.  In this regard, it would appear that
under Section 351 an exchange would be considered tax free if (a) the property was
exchanged solely for stock of the company and (b) immediately after the exchange the
transferor controlled the company via 80% or more ownership of voting stock.  Based on
your beneficial ownership table on page 49, it appears that CoNCERT owns only 5.4% of
your outstanding shares.
            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.

 FirstName LastNameDavid Young
 Comapany NameProcessa Pharmaceuticals, Inc.
 August 28, 2018 Page 6
 FirstName LastName
David Young
Processa Pharmaceuticals, Inc.
August 28, 2018
Page 6
            Refer to Rules 460 and 461 regarding requests for acceleration.  Please allow adequate
time for us to review any amendment prior to the requested effective date of the registration
statement.
            You may contact Andi Carpenter at 202-551-3645 or Angela Connell at 202-551-3426 if
you have questions regarding comments on the financial statements and related matters.  Please
contact Dorrie Yale at 202-551-8776 or Ada Sarmento at 202-551-3798 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
cc:       Neda Sharifi

CORRESP
1
filename1.htm

Correspondence

 May 31, 2013

 Amanda Ravitz, Assistant Director

 Division of Corporation Finance

 Securities and Exchange Commission

 Washington, DC 20549

 Re:

 Heatwurx, Inc.

 Registration Statement on Form S-1

 File No. 333-184948

 Request for Effectiveness

 Dear Ms. Ravitz:

 Pursuant to Rule 461 of Regulation C promulgated by the Securities and Exchange Commission under the Securities Act of 1933, as amended (the “Act”), Heatwurx, Inc. (the “Company”) hereby requests that the registration statement of the Company on Form S-1 (Commission File No. 333-184948) be granted an effective date of June 5, 2013, 3:00 p.m. EDT, or as soon thereafter as possible.  We request that we be notified of such effectiveness by a telephone call to Ronald N. Vance, Attorney at Law at (801) 446-8802 and that such effectiveness also be confirmed in writing and delivered to our legal counsel by email at ron@vancelaw.us or by fax at (801) 446-8803.

 This request for acceleration will acknowledge that the Company is aware of its obligations under the Act and the Securities Exchange Act of 1934 as they relate to the proposed public offering of the securities specified in the above registration statement.  The Company further acknowledges that:

 ·

 should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing;

 ·

 the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and

 ·

 the Company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.

 Sincerely,

 /s/ Stephen Garland

 Stephen Garland, CEO

 cc:  Ronald N. Vance, Esq.

May 21, 2013
Allen Dodge
Chief Financial Officer
Heatwurx, Inc.
6041 South Syracuse Way, Suite 315
Greenwood Village, CO 80111

Re: Heatwurx, Inc.
Amendment No. 4 to Registration Statement on Form S -1
Filed May 15, 2013
  File No. 333 -184948

Dear Mr. Dodge :

We have reviewed your registration statement  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 this letter by amending your registration statement and providing the
requested information .  If you do not believe our comments apply to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.

After reviewing any amendment to your registration statement and the information you
provide in response to these  comments, we may have  additional comments.

Registration Fee Table

1. We note that footnote ( 4) as written appears t o exceed the scope of Rule 416; specifically,
we note your reference to “other anti -dilution adjustments.”  Please revise the footnote to
track the language of Rule 416.

Prospectus Cover Page

2. We note your disclosure that the selling stockholders will sell at $3.00 per share until
your shares “are quoted on the OTC Markets quotation service and thereafter at
prevailing mark et prices....”  Please revise to clarify the specific OTC Market tier on
which your shares will become quoted.

Prospectus Summary, page 1

3. In your Summary, where you discuss the  need to raise additional funds, please revise to
highlight that you antici pate the need to secure $4 million over the next 12 months to

Allen Dodge
Heatwurx, Inc.
May 21, 2013
Page 2

 meet your cash flow requirement and repay your secured debt , and that you have
approximately $422,000 cash on hand and are spending approximately $250,000 per
month, as you disclose on page 5 .  Further, this information should be disclosed at least
as prominently as your disclosure concerning the proceeds raised in the preferred stock
offerings in 2011 and 2012.  Please revise accordingly.

Exhibit 5.1

4. We note your state of incorporation is Delaware.  Please file an opinion that is not
qualified to the corporate laws of the state of Nevada.

We urge all persons who are responsible for the accuracy and adequacy of the disclosure
in the filing to be cert ain that the filing includes the information the Securities Act of 193 3 and
all applicable Securities  Act rules require.   Since the company and its management are in
possession of all facts relating to a company’s disclosure, they are responsible for the a ccuracy
and adequacy of the disclosures they have made.

Notwithstanding our comments, in the event you request acceleration of the effective date
of the pending regist ration statement please provide  a written statement from the company
acknowledging tha t:

 should the Commission or the staff, acting pursuant to delegated authority, declare the
filing effective, it does not foreclose the Commission from taking any action with respect
to the filing;

 the action of the Commission or the staff, acting pursua nt to delegated authority, in
declaring the filing effective, does not relieve the company from its full responsibility for
the adequacy and accuracy of the disclosure in the filing; and

 the company may not assert staff comments and the declaration of effectiveness as a
defense in any proceeding initiated by the Commission or any person under the federal
securities laws of the United States.

Please refer to Rules 460 and 461 regarding reque sts for  acceleration .  We will consider a
written request for acceleration of the effective date of the registration statement as confirmation
of the fact that those requesting acceleration are aware of their respective responsibilities under
the Securitie s Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed
public offering of the securities specified in the above registration statement.  Please allow
adequate time  for us to review any amendment prior to the requested effectiv e date of the
registration statement.

Allen Dodge
Heatwurx, Inc.
May 21, 2013
Page 3

You may contact Kristin Lochhead  at (202) 551 -3664  or Brian Cascio, Accounting
Branch Chief, at (202) 551 -3676 if you have questions regarding comments on the financial
statements and related matters.  Please contact Mary Beth Breslin at (202) 551 -3625  or me at
(202) 551 -3528 with any other questions.

Sincerely,

 /s/ Mary Beth Breslin for

Amanda Ravitz
Assis tant Director

cc (via e -mail): Ronald N. Vance

April 17, 2013
Stephen Garland
Chief Executive Officer
Heatwurx, Inc.
6041 South Syracuse Way, Suite 315
Greenwood Village, CO 80111

Re: Heatwurx, Inc.
Amendment No. 3 to Registration Statement on Form S -1
Filed April 11 , 2013
  File No. 333-184948

Dear Mr. Garland :

We have reviewed your registration statement  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 this letter by amending your registration statement and providing the
requested information .  If you do not believe our comments apply to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.

After reviewing any amendment to your registration statement and the information you
provide in response to these  comments, we may have  additional comments.

Heatwurx Inc. Financial Statements, page  F-1

Balance Sheet as of December 31, 2012 and 2011, page F -3

1. We note that you adjusted cash and accrued liabilities in the pro forma financial
information for the payment of the accrued dividend with respect to the Company’s
Series C Preferred shares of  $49,172, as though the completion of the initial public
offering contemplated by the accompanying prospectus had occurred on December 31,
2012.   Since the payment of the dividends is unrelated to the proposed equity transaction,
please limit the pro forma  information to only the shareholder’s equity section of the
balance sheet.    Please also revise your footnote accordingly .

Statement of Stockholder’s Equity, page F -5

2. We see that you are a development stage company.   Please tell us why you do not pres ent
a statement of stockholder’s equity from the inception of the predecessor company
(January 1, 2009) as required by FASB 915 -215.

Stephen Garland
Heatwurx, Inc.
April 17, 2013
Page 2

 We urge all persons who are responsible for the accuracy and adequacy of the disclosure
in the filing to be certain that the filing includes the information the Securities Act of 193 3 and
all applicable Securities  Act rules require.   Since the company and its management are in
possession of all facts relating to a company’s disclosure, they are responsible for the accuracy
and adequacy of the disclosures they have made.

Notwithstanding our comments, in the event you request acceleration of the effective date
of the pending regist ration statement please provide  a written statement from the company
acknowledging that:

 shoul d the Commission or the staff, acting pursuant to delegated authority, declare the
filing effective, it does not foreclose the Commission from taking any action with respect
to the filing;

 the action of the Commission or the staff, acting pursuant to delegated authority, in
declaring the filing effective, does not relieve the company from its full responsibility for
the adequacy and accuracy of the disclosure in the filing; and

 the company may not assert staff comments and the declaration of effectiveness as a
defense in any proceeding initiated by the Commission or any person under the federal
securities laws of the United States.

Please refer to Rules 460 and 461 regarding reque sts for  acceleration .  We will consider a
written request for acceleration of the effective date of the registration statement as confirmation
of the fact that those requesting acceleration are aware of their respective responsibilities under
the Securitie s Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed
public offering of the securities specified in the above registration statement.  Please allow
adequate time  for us to review any amendment prior to the requested effectiv e date of the
registration statement.

You may contact Kristin Lochhead  at (202) 551 -3664  or Brian Cascio, Accounting
Branch Chief, at (202) 551 -3676 if you have questions regarding comments on the financial
statements and related matters.  Please con tact Mary Beth Breslin  at (202) 551 -3625  or me at
(202) 551 -3528 with any other questions.

Sincerely,

 /s/ Mary Beth Breslin for

Ama nda Ravitz
Assistant Director

cc (via e -mail): Howard J. Kern

April 4 , 2013
Stephen Garland
Chief Executive Officer
Heatwurx, Inc.
6041 South Syracuse Way, Suite 315
Greenwood Village, CO 80111

Re: Heatwurx, Inc.
Amendment No. 2 to Registration Statement on Form S -1
Filed March 14 , 2013
  File No. 333-184948

Dear Mr. Garland :

We have reviewed your registration statement  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 this letter by amending your registration statement and providing the
requested information .  If you do not believe our comments apply to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.

After reviewing any amendment to your registration statement and the information you
provide in response to these  comments, we may have  additional comments.

Fee Table

1. We note your response to pri or comment 1; however, the table as revised now omits the
units themselves.  Please revise to ensure that all of the securities being offered – the
units themselves, as well as each security comprising the units – are separately reflected
in the fee table .

Prospectus Summary, page 1

2. We note your auditor has added an explanatory paragraph to its opinion on page F -2 that
there exists substantial doubt about your ability to continue as a going concern.  Please
expand your Summary to disclose your history of  losses, quantify your accumulated
deficit, and highlight the existence of the “going concern” language in your audit report.

Stephen Garland
Heatwurx, Inc.
April 4, 2013
Page 2

 The Offering, page 3

3. We note you added “debt repayment” as one of the expected uses of proceeds for this
offering.  Please e xpand your Summary to disclose the expected portion of proceeds to be
allocated toward each use, and please expand your “Use of Proceeds” section beginning
on page 17 to provide the information required by instruction 4 to Item 504 of Regulation
S-K with r espect to the proceeds to be used to repay indebtedness.

Management’s Discussion and Analysis..., page 20

4. Please tell us why you no longer present the predecessor operations of the Heatwurx
business for the periods through April 15, 2011 throughout your filing.   Refer to Rule 405
of Regulation C which states that predecessor financial statements are required if a
registrant succeeds to substantially all of the business (or a separately ident ifiable line of
business) of another entity (or group of entities) and the registrant's own operations
before the succession appear insignificant relative to the operations assumed or acquired.

Heatwurx Inc. Financial Statements, page F -1

Balance Sheet a s of December 31, 2012 and 2011, page F -3
Statements of Operations, page F -4

5. We see that shares of Series A, B and C Preferred Stock will convert automatically into
shares of common stock upon the closing date of the offering.   Please revise to present
the pro forma balance sheet for the most recent period (excluding effects of offering
proceeds) alongside of the historical balance sheet giving effect to the change in
capitalization.   In your statements of operations revise   to present pro forma EPS for t he
most recent period giving effect to the conversion (but not the offering).

Notes to Financial Statements , page F -7

Note 2.   Summary of Significant Accounting Policies, page F -7

Intangible Assets, page F -8

6. We see that as of October 1, 2012, in -process research and development is now classified
as developed technology and amortized over its estimated useful life of 7 years.    Please
revise to include all of the relevant disclosures required by FASB ASC 350 -30-50.

Revenue Recognition, page F -8

7. Please revise your disclosure to clarify if you have any post shipment obligations or
customer acceptance provisions with the sale of your equipment and, if so, how such
obligations and provisions are considered in your revenue recognition practices.

Stephen Garland
Heatwurx, Inc.
April 4, 2013
Page 3

8. We not e the disclosure on page 28 that you do not intend to sell directly into any of the
end markets but instead intend to rely on distribution agreements with other companies.
Please revise to clarify if your sales are made to distributors or end users.   With respect to
any distributor agreements, please describe the significant terms related to payment,
return, exchanges, and other significant matters and how those terms impact your revenue
recognition policy.

9. Please revise to disclose your revenue recogni tion policy for revenue generated from
equipment rentals.

Stock Options, page F -14

10. We reference the disclosure on page 21 that you utilized a $2.00 estimate of fair value for
a share of your common stock for all options issued during the period from October 2011
to August 2012.   Please reconcile that statement with the disclosures in the  chart on page
F-15 that the fair value range of options at the grant date for December 31, 2012 was
$0.675 - $0.705 per share and for December 31, 2011 was $0.704 - $0.710.

11. Please also revise to include a discussion of how you determined each of the a ssumptions
included in the Black -Scholes option pricing model for stock options issued during the
periods presented.

Exhibit 23. Consent of Independent Registered Public Accounting Firm

12. In your next amendment, please provide a currently dated and signe d consent from your
independent accountant.   We note that the consent included in the most recent
amendment does not include a conformed signature from the independent accountants.

We urge all persons who are responsible for the accuracy and adequacy of the disclosure
in the filing to be certain that the filing includes the information the Securities Act of 193 3 and
all applicable Securities  Act rules require.   Since the company and its management are in
possession of all facts relating to a company’s dis closure, they are responsible for the accuracy
and adequacy of the disclosures they have made.

Notwithstanding our comments, in the event you request acceleration of the effective date
of the pending regist ration statement please provide  a written state ment from the company
acknowledging that:

 should the Commission or the staff, acting pursuant to delegated authority, declare the
filing effective, it does not foreclose the Commission from taking any action with respect
to the filing;

Stephen Garland
Heatwurx, Inc.
April 4, 2013
Page 4

  the action of the  Commission or the staff, acting pursuant to delegated authority, in
declaring the filing effective, does not relieve the company from its full responsibility for
the adequacy and accuracy of the disclosure in the filing; and

 the company may not assert staff comments and the declaration of effectiveness as a
defense in any proceeding initiated by the Commission or any person under the federal
securities laws of the United States.

Please refer to Rules 460 and 461 regarding reque sts for  acceleration .  We will consider a
written request for acceleration of the effective date of the registration statement as confirmation
of the fact that those requesting acceleration are aware of their respective responsibilities under
the Securitie s Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed
public offering of the securities specified in the above registration statement.  Please allow
adequate time  for us to review any amendment prior to the requested effective date of the
registration statement.

You may contact Kristin Lochhead  at (202) 551 -3664  or Brian Cascio, Accounting
Branch Chief, at (202) 551 -3676 if you have questions regarding commen ts on the financial
statements and related matters.  Please contact Mary Beth Breslin  at (202) 551 -3625  or me at
(202) 551 -3528 with any other questions.

Sincerely,

 /s/ Mary Beth Breslin for

Ama nda Ravitz
Assistant Director

cc (via e -mail): How ard J. Kern

January 25, 2013
Stephen Garland
Chief Executive Officer
Heatwurx, Inc.
6041 South Syracuse Way, Suite 315
Greenwood Village, CO 80111

Re: Heatwurx, Inc.
Amendment No. 1 to Registration Statement on Form S -1
Filed January 11, 2013
  File No. 333-184948

Dear Mr. Garland :

We have reviewed your registration statement  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 this letter by amending your registration statement and providing the
requested information .  If you do not believe our comments apply to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.

After reviewing any amendment to your registration statement and the information you
provide in response to these  comments, we may have  additional comments.

Fee Table

1. We note your revised fee tab le in response to prior comment 1.  Please further revise to
reflect each security comprising the units separately in the table.

Prospectus Cover Page

2. With a view toward clarified disclosure, please tell us the status of your application to list
your sh ares and warrants on the NYSE MKT exchange.  In particular, tell us whether you
plan to move forward with your offering s prior to obtaining a listing on the NYSE MKT.

3. We note your response s to prior comment s 4 and 32  and the revised disclosure on the
cover page of the selling stockholders  prospectus that the selling stockholders may not
sell any of their common stock until the underwriters have completed the primary
offering “excluding the overallotment portion.”  Please clarify whether the selling
stockholders offering can commence prior to the completion of the primary offering in
the event the underwriters choose to exercise the overallotment option. If it may

Stephen Garland
Heatwurx, Inc.
January 25, 2013
Page 2

 commence before the overallotment shares are sold, please revise to disclose how the
price of the overallotment shares differs from the price of the shares being offered by the
selling stockholders and include appropriate risk factor disclosure.  Otherwise, p lease
revise to state that the secondary offering will not begin until the primary offer ing has
been completed.

Revenue, page 2 2

4. We see the revisions made in response to prior comment 12.   To the extent that it
impacted revenues, please further revise to also discuss any changes in the volume or
price of units sold during the periods presented.    Refer to Item 303(a)(3) of Regulation
S-K.

Executive Compensation, page 34

5. Please update your disclosure pursuant to Item 402 of Regulation S -K for the last
completed fiscal year ended December 31, 2012.

Underwriting, page 44

6. We note your response to prior comment 21.  Given his participation in the distribution of
your shares in a public offering , please provide us with a detailed analysis as to whether
Mr. Giles should be identified as an underwriter within the meaning of Sec tion 2(a)(11)
of the Securities Act with respect to the shares that he will sell to you in connection with
the overallotment option.

Note 4.   Acquisition, page F -11

7. Please refer to prior comment 26. We reference the statement on page 39 that as of the
date of the asset purchase agreement, Mr. Giles owned 50% of the company and also
owned the acquired technology.   Please tell us how you considered that the two entities
were under common control and the assets should be transferred at historical cost unde r
FASB ASC 805 -50-30.

Selling Stockholders Prospectus Cover Page , page SS -2

8. We note your response to prior comment s 4 and  29 and your revised disclosure that you
“have assumed” that the selling shareholders will sell their stock at $5.15 per share.
Please note that given the lack of an established trading market for your shares, the
offering price must be fixed and disclosed as such ; it is not appropriate to assume what
the price will be.  Refer to Item 501(b)(3) of Regulation S -K and Schedule A, p aragraph
16 of the Securities Act of 1933.  While we have no objection if you disclose that the
shares being offered by the selling stockholders will be sold at the disclosed fixed price
until your shares are listed on the NYSE MKT and thereafter at prevai ling market prices

Stephen Garland
Heatwurx, Inc.
January 25, 2013
Page 3

 or privately negotiated prices, the offering price must be fixed until that time.  Please
revise your disclosure accordingly.

We urge all persons who are responsible for the accuracy and adequacy of the disclosure
in the filing to be certain that the filing includes the information the Securities Act of 193 3 and
all applicable Securities  Act rules require.   Since the company and its management are in
possession of all facts relating to a company’s disclosure, they are responsible for the accuracy
and adequacy of the disclosures they have made.

Notwithstanding our comments, in the event you request acceleration of the effective date
of the pending regist ration statement please provide  a written statement from the company
acknowledging that:

 should the Commission or the staff, acting pursuant to delegated authority, declare the
filing effective, it does not foreclose the Commissi on from taking any action with respect
to the filing;

 the action of the Commission or the staff, acting pursuant to delegated authority, in
declaring the filing effective, does not relieve the company from its full responsibility for
the adequacy and acc uracy of the disclosure in the filing; and

 the company may not assert staff comments and the declaration of effectiveness as a
defense in any proceeding initiated by the Commission or any person under the federal
securities laws of the United States.

Please refer to Rules 460 and 461 regarding requests for  acceleration .  We will consider a
written request for acceleration of the effective date of the registration statement as confirmation
of the fact that those requesting acceleration are aware of their  respective responsibilities under
the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed
public offering of the securities specified in the above registration statement.  Please allow
adequate time  for us to revi ew any amendment prior to the requested effective date of the
registration statement.

Stephen Garland
Heatwurx, Inc.
January 25, 2013
Page 4

 You may contact Kristin Lochhead  at (202) 551 -3664  or Brian Cascio, Accounting
Branch Chief, at (202) 551 -3676 if you have questions regarding comments on the finan cial
statements and related matters.  Please contact Mary Beth Breslin  at (202) 551 -3625  or me at
(202) 551 -3528 with any other questions.

Sincerely,

 /s/ Mary Beth Breslin for

Ama nda Ravitz
Assistant Director

cc (via e -mail): Howard J. Kern

December 11, 2012
Stephen Garland
Chief Executive Officer
Heatwurx, Inc.
6041 South Syracuse Way, Suite 315
Greenwood Village, CO 80111

Re: Heatwurx, Inc.
Registration Statement on  Form S -1
Filed November 14, 2012
  File No. 333-184948

Dear Mr. Garland :

We have reviewed your registration statement  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 this letter by amending your registration statement and providing the
requested information .  If you do not believe our comments apply to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.

After reviewing any amendment to your registration statement and the information you
provide in response to these  comments, we may have  additional comments.

Fee Table

1. We refer to your prospectus cover page and disclosure on page 2 and elsewhere
indicating that you are selling units in the offering.  Please revise the fee table to reflect
these un its.  Also revise footnote (1) to clarify the paragraph of rule 457 on which you are
relying.

Prospectus Cover  Page

2. Since you appear to qualify as an “emerging growth company,” as defined in the
Jumpstart Our Business Startups Act, please disclose on your prospectus cover page that
you are an emerging growth company, and revise your prospectus to:
 Describe how and when a company may lose emerging growth company status;
 Briefly describe the various exemptions that are available to you, such as exemption s
from Section 404(b) of the Sarbanes -Oxley Act of 2002 and Section 14A(a) and (b)
of the Securities Exchange Act of 1934; and

Stephen Garland
Heatwurx, Inc.
December 11, 2012
Page 2

  State your election under Section 107(b) of the JOBS Act:
o If you have elected to opt out of the extended transition period for co mplying
with new or revised accounting standards pursuant to Section 107(b), include
a statement that the election is irrevocable; or
o If you have elected to use the extended transition period for complying with
new or revised accounting standards under Section 102(b)(1), provide a risk
factor explaining that this election allows you to delay the adoption of new or
revised accounting standards that have different effective dates for public and
private companies until those standards apply to private compa nies.  Please
state in your risk factor that, as a result of this election, your financial
statements may not be comparable to companies that comply with public
company effective dates.  Include a similar statement in your critical
accounting policy disclo sures.
In addition, consider describing the extent to which any of these exemptions are available
to you as a Smaller Reporting Company.

3. Please supplementally provide us with copies of all written communications, as defined
in Rule 405 under the Securitie s Act, that you , or anyone authorized to do so on your
behalf , present to potential investors in reliance on Section 5(d) of the Securities Act,
whether or not they retain copies of the communications.  Similarly, please
supplementally provide us with any research reports about you that are published or
distributed in reliance upon Section 2(a)(3) of the Securities Act of 1933 added by
Section 105(a) of the Jumpstart Our Business Startups Act by any broker or dealer that is
participating or will participate  in your offering.

4. We note your disclosure regarding a concurrent resale offering of common stock by
selling shareholders for which you have included alternate pages for use in a separate
prospectus.  Expand the cover pag e and elsewhere, as appropriate, to disclose how the
price of the shares being offered by the selling stockholders differs from the price of the
shares you are offering in this underwritten offering.

Prospectus Summary , page 1

5. Please revise to disclose the price that your founders paid t o Mr. Giles in the acquisition
transaction.  Please also discuss the historical development of the business and the
technology during the past three years, including discussion of the “predecessor” entity.
Please also revise to explain whether your founde rs have any present involvement with
the business or retain an ownership stake.  To the extent that the founders have no
association with the business, please revise to explain the circumstances surrounding their
disassociation.

6. We note your statement that you are an “Original Equipment Manufacturer of asphalt
preservation and repair equipment;” however, your disclosures on pages 4 and 23

Stephen Garland
Heatwurx, Inc.
December 11, 2012
Page 3

 indicate that you outsource all of your manufacturing to a single manufacturer.  Please
revis e to clarify the nature of your business operations.

Risk Factors, page 3

7. Please include a risk factor that describes the risk to purchasers in your underwritten
offering of the risk that, once your common stock becomes listed on the NYSE MKT
exchange, i nvestors will be able to purchase from selling shareholders in the concurrent
offering at the market price rather than the fixed, underwritten offering price.

Management’s Discussion and Analysis..., page 18

8. Please tell us why you use April 16, 2011 as the date of incorporation throughout the
filing rather than the actual date of incorporation of March 29, 2011.  Also, please
reconcile with the presentation in the Statement of Stockholder’s Equity.

Critical Accounting Policies and Estimates, page 19

Stock -Based Compensation, page 19

9. Please revise to include a discussion of the judgments considered in determining each of
the assumptions used in the Black -Scholes option -pricing model in determining the fair
value of stock option grants in the 12 months before the proposed offering.  In this
regard, please specifically discuss how you determined the fair value of your common
stock at each stock option issuance date.   Please also tell us how you considered any
issuances of preferred stock during the period.

10. Please provide a specific discussion of each significant factor contributing to the
difference between the estimated fair value of your stock and the offering price of $5.00
allocated to the common stock for each issuance in the 12 months prior to the
contemplated IPO.

Results of Operations, page 20

Revenue, page 20

11. You state that revenue “decreased” from the nine months ended September 30, 2011 to
the nine months ended September 30, 2012.  However, i t appears that revenue actually
increased.  Please revise as appropriate.  In addition, please clarify if the sales made in
the nine months ended September 30, 2012 were prototype units.

12. Please revise to include a discussion of the components of revenu e for the year ended
December 31, 2011 and 2010 and provide an indication of any changes in composition,

Stephen Garland
Heatwurx, Inc.
December 11, 2012
Page 4

 volume or price of units sold during those periods.   Refer to Item 303( a)(3) of
Regulation S -K.

Selling General and Administrative Expenses, page 2 0

13. Please revise to quantify each item you list as contributors to the increase in selling
general and administrative expenses.

Business, page 23

14. Please revise to disclose the steps you must take in order to “fully” commercialize and
the timeline for doing so.

15. Please provide us with independent, objective support for your statements here and in
your Prospectus Summary that you believe that your equipment, technology and
processes are innovative, eco -friendly, and provide savings over other processes.  Please
also provide independent, objective support for your disclosure on page 27 concerning
the effectiveness of your equipment and the quality of your design. In addition, please
revise your Business disclosure to describe briefly any disadvantages asso ciated with
infrared heating technology and/or your products.

AASHTO TIG 2012, page 23

16. Please refer to Rule 436(a) and file as an exhibit the consent of the Utah Department of
Transportation for the quotations you include in this section.

Sources and Availability of Raw Materials , page 26

17. We note your disclosures on pages 4 and 26 concerning your reliance on a single
manufacturer of your equipment.  Please revise to identify this sole supplier.  Please refer
to Regulation S -K, Item 101(h)(4)(vi).

Intellectual Property , page 27

18. With a view toward clarified disclosure, please tell us why the  U.S. Patent Office rejected
your first patent application.

Security Ownership, page 34

19. We note the disclosures in footnotes 6 and 7 to the table concerning th e beneficial
holdings of Mr. Yorke and Mr. Kirby.  Please refer to Regulation S -K, Item 403(a) and
revise the table so that it reflects the beneficial holdings of each beneficial owner rather
than including separate disclosure for the holdings of each  entity controlled by these
individuals.

Stephen Garland
Heatwurx, Inc.
December 11, 2012
Page 5

Certain Relationships and Related Transactions , page 36

20. Please refer to Regulation S -K, Item 404(d ), including instruction 1 to Item 404(d), and
revise to disclose all applicable related -party transactions, including, without limitation,
the asset purchase agreement with Mr. Giles as well as your stock purchase, loan, voting
and other agreements with related persons.

Underwriting, page 40

21. We note your dis closure on page 40 that “of the 225,000 units, 200,000 are being sold by
the underwriter.”  Please tell us whether the selling stockholder owns units or holds any
warrants that could be sold directly to the underwriter.  To the extent that the selling
stockholder does not own units or hold warrants, please tell us the manner in which the
underwriters will obtain these units and warrants.

Financial Statements , page F -1

22. Please update the financial statements when required by Rule 8 -08 of Regulation S -X.

Statement of Operations, page F -4

23. Please revise to reconcile net income to income available to common shareholders on the
face of the income statement.  Refer to SAB Topic 6B.

Statements of Stockholder’s Equity, page F -5

24. Please revise to show for each stock issuance, the date and number of shares of stock
issued, the dollar amount assigned to the consideration received for equity, the nature of
any noncash consideration and the basis for assigning such amounts to the consideration.
Refer to FASB ASC 91 5-215 for development stage entities.

Note 2.  Summary of Significant Accounting Policies, page F -8

Revenue Recognition, page F-10

25. We see that revenue is recognized when the equipment is shipped and collection is
reasonably assured.   Please tell us specifically how you apply SAB Topic 13 to your
arrangements.  In that regard, please revise to disclose when persuasive evidence of an
arrangement exists, delivery has occurred or services have been rendered, the seller's
price to the buyer is fixed or determinable and collectability is reasonably assured.

Stephen Garland
Heatwurx, Inc.
December 11, 2012
Page 6

 Note 4.  Acquisition, page F -11

26. We reference the statement that you entered into  an Asset Purchase Agreement with an
individual who is a current stockholder.  Please tell us how you considered SAB Topic
5G in your accounting for this transaction.

27. We see that you allocated the entire purchase price for the Heatwurx transaction to
IPR&D.  In that regard, we see that you also acquired all trademarks and trade names,
domain names, patent applications, customer relationships, etc.  Please tell us how you
considered allocating the purchase price to these other assets acquired.  Refer to FASB
ASC 805 -20-55.

28. We reference the disclosure that you recognized the estimated fair value of contingent
consideration as $0.  Please revise to disclose basis for determining the fair value of the
contingent consideration and an estimate of the range of outcomes.  Refer to FASB 805 -
30-50-1(c).

Selling Stockholder Prospectus Cover Page, page SS -2

29. Note that Schedule A, paragraph 16 of the Securities Act and Item 501(b)(3) of
Regulation S -K require that you disclose the price at which the securities will be sold.
Given the lack of an established market for your securities, please disclose the fixed price
you intend to sell the shares listed in this prospectus.  We will not object if you disclose
that the securities will be sold at the disclosed fixed  price until your shares are listed on
the NYSE MKT and thereafter at prevailing market prices or privately negotiated prices.

Selling Stockholder, page SS-3

30. Given the nature and size of the offering, please tell us your basis for determining that the
transaction is appropriately characterized as a transaction that is eligible to be made on a
shelf basis under Rule 415(a)(1)(i).  Also, in your response, please ad dress specifically
whether Mess rs. Giles, Yorke and Kirby should not be identified as underw riters.  Please
also tell us whether any of the selling stockholders are broker -dealers or affiliates of
broker -dealers.  For guidance, refer to Compliance and Disclosure Interpretation 612.09
of Securities Act Rules, available on the Commission’s website.

31. We note that numerous selling shareholders appear in each of the separate tables
presented on pages SS -3 through SS -6.  Please revise to consolidate the information in
the multiple tables into one table that reflects , in a single line for each individua l selling
shareholder,  all of the common shares that holder is offering.

Stephen Garland
Heatwurx, Inc.
December 11, 2012
Page 7

 Sale of Securities and Plan of Distribution , page SS-7

32. We note  your description of the two offerings as “concurrent.”  Please revise this section,
the prospectus cover page and elsewhere as appropriate to disclose when the selling
stockholders will be able to commence the resale of their shares.  In this regard, it i s
unclear whether the selling stockholders will be able to sell pursuant to the selling
stockholder registration statement prior to the underwriter’s placement of the units in the
firm commitment offering.

Exhibit 23 . Consent of Independent Registered Pub lic Accounting Firm

33. To the extent there is a delay in requesting effectiveness of your registration statement, or
there is any change, other than typographical, made to the financial statements, or there
have been intervening events since the prior filing  that are material to the company,
please provide a currently dated and signed consent from your independent accountant
with your next amendment.

We urge all persons who are responsible for the accuracy and adequacy of the disclosure
in the filing to be c ertain that the filing includes the information the Securities Act of 193 3 and
all applicable Securities  Act rules require.   Since the company and its management are in
possession of all facts relating to a company’s disclosure, they are responsible for th e accuracy
and adequacy of the disclosures they have made.

Notwithstanding our comments, in the event you request acceleration of the effective date
of the pending regist ration statement please provide  a written statement from the company
acknowledging that:

 should the Commission or the staff, acting pursuant to delegated authority, declare the
filing effective, it does not foreclose the Commission from taking any action with respect
to the filing;

 the action of the Commission or the staff, acting pur suant to delegated authority, in
declaring the filing effective, does not relieve the company from its full responsibility for
the adequacy and accuracy of the disclosure in the filing; and

 the company may not assert staff comments and the declaration of effectiveness as a
defense in any proceeding initiated by the Commission or any person under the federal
securities laws of the United States.

Please refer to Rules 460 and 461 regard