PCSA

0001533743
false

0001533743

2023-03-30
2023-03-30

iso4217:USD

xbrli:shares

iso4217:USD

xbrli:shares

UNITED
STATES

SECURITIES
AND EXCHANGE COMMISSION

Washington,
D.C. 20549

FORM
8-K

CURRENT
REPORT

PURSUANT
TO SECTION 13 OR 15(d) OF THE

SECURITIES
EXCHANGE ACT OF 1934

Date
of Report (Date of earliest event reported): March 30, 2023

Commission
file number 001-39531

PROCESSA
PHARMACEUTICALS, INC.

(Exact
name of Registrant as Specified in its Charter)

Delaware

45-1539785

(State
or Other Jurisdiction of

Incorporation or Organization)

(I.R.S.
Employer

Identification Number)

7380
Coca Cola Drive, Suite 106, Hanover, Maryland 21076

(Address
of Principal Executive Offices, Including Zip Code)

(443)
776-3133

(Registrant’s
Telephone Number, Including Area Code)

(Former
Name or Former Address, if Changed Since Last Report)

Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions:

☐
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities
registered pursuant to Section 12(b) of the Act:

Title
of each class

Trading
symbol(s)

Name
of each exchange on which registered

Common

PCSA

Nasdaq
Capital Market

Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging
growth company ☐

If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item
2.02 Results of Operations and Financial Condition.

On
March 30, 2023, Processa Pharmaceuticals, Inc. (the “Company”) issued an earnings release announcing its financial results
for the year ended December 31, 2022. A copy of the earnings release is furnished as Exhibit 99.1 to this Current Report on Form 8-K
(this “Report”).

The
information in this Item 2.02 and Exhibit 99.1 hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities
Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, nor shall it
be deemed incorporated by reference in any of the Company’s filings under the Securities Act of 1933, as amended (the “Securities
Act”), or the Exchange Act.

Item
7.01 Regulation FD Disclosure.

Corporate
Presentation

On
March 30, 2023, the Company posted an updated corporate presentation to its website at https://www.processapharmaceuticals.com/,
which the Company may use from time to time in communications or conferences. A copy of the corporate presentation is attached as
Exhibit 99.2 to this Report.

The
information in this Item 7.01 and Exhibits 99.2 shall not be deemed “filed” for purposes of Section 18 of the Exchange Act
or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing under the Securities
Act or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Exhibit
99.2 hereto contains forward-looking statements within the meaning of the federal securities laws. These forward-looking statements are
based on current expectations and are not guarantees of future performance. Further, the forward-looking statements are subject to the
limitations listed in Exhibit 99.2 and in the other reports of the Company filed with the Securities and Exchange Commission, including
that actual events or results may differ materially from those in the forward-looking statements.

Item
9.01. Financial Statements and Exhibits.

Exhibit
No.

Exhibit
Description

99.1

Earnings release, dated March 30, 2023 announcing Processa Pharmaceuticals, Inc. financial results for the year ended December 31, 2022

99.2

Corporate Presentation, dated March 30, 2023

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURE

Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned, hereunto duly authorized, on March 30, 2023.

PROCESSA
PHARMACEUTICALS, INC.

Registrant

By:
/s/
David Young

David
Young

Chief
Executive Officer

0001533743
false

0001533743

2022-11-08
2022-11-08

iso4217:USD

xbrli:shares

iso4217:USD

xbrli:shares

UNITED
STATES

SECURITIES
AND EXCHANGE COMMISSION

Washington,
D.C. 20549

FORM
8-K

CURRENT
REPORT

PURSUANT
TO SECTION 13 OR 15(d) OF THE

SECURITIES
EXCHANGE ACT OF 1934

Date
of Report (Date of earliest event reported): November 8, 2022

Commission
file number 001-39531

PROCESSA
PHARMACEUTICALS, INC.

(Exact
name of Registrant as Specified in its Charter)

Delaware

45-1539785

(State
or Other Jurisdiction of

Incorporation
or Organization)

(I.R.S.
Employer

Identification
Number)

7380
Coca Cola Drive, Suite 106, Hanover, Maryland 21076

(Address
of Principal Executive Offices, Including Zip Code)

(443)
776-3133

(Registrant’s
Telephone Number, Including Area Code)

(Former
Name or Former Address, if Changed Since Last Report)

Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions:

☐
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities
registered pursuant to Section 12(b) of the Act:

Title
of each class

Trading
symbol(s)

Name
of each exchange on which registered

Common

PCSA

Nasdaq
Capital Market

Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging
growth company ☐

If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item
2.02 Results of Operations and Financial Condition.

On
November 8, 2022, Processa Pharmaceuticals, Inc. (the “Company”) issued an earnings release announcing its financial results
for the quarter ended September 30, 2022. A copy of the earnings release is furnished as Exhibit 99.1 to this Current Report on Form
8-K (this “Report”).

The
information in this Item 2.02 and Exhibit 99.1 hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities
Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, nor shall it
be deemed incorporated by reference in any of the Company’s filings under the Securities Act of 1933, as amended (the “Securities
Act”), or the Exchange Act.

Item
7.01 Regulation FD Disclosure.

Results
of PCS 12852 Phase 2A Trial

On
November 8, 2022, the Company issued a press release announcing positive gastric emptying results from its PCS12852 Phase 2A trial in
patients with moderate to severe gastroparesis. A copy of the press release is furnished as Exhibit 99.2 to this Report.

Corporate
Presentation

On
November 8, 2022, the Company posted an updated corporate presentation to its website at https://www.processapharmaceuticals.com/, which
the Company may use from time to time in communications or conferences. A copy of the corporate presentation is attached as Exhibit 99.3
to this Report.

The
information in this Item 7.01 and Exhibits 99.2 and 99.3 shall not be deemed “filed” for purposes of Section 18 of the Exchange
Act or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing under the
Securities Act or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Exhibit
99.3 hereto contains forward-looking statements within the meaning of the federal securities laws. These forward-looking statements are
based on current expectations and are not guarantees of future performance. Further, the forward-looking statements are subject to the
limitations listed in Exhibit 99.3 and in the other reports of the Company filed with the Securities and Exchange Commission, including
that actual events or results may differ materially from those in the forward-looking statements.

Item
9.01. Financial Statements and Exhibits.

Exhibit
No.

Exhibit
Description

99.1

Earnings release, dated November 8, 2022 announcing Processa Pharmaceuticals, Inc. financial results for the quarter ended September 30, 2022

99.2

Press release, dated November 8, 2022 announcing results from its PCS12852 Phase 2A trial

99.3

Corporate Presentation, dated November 8, 2022

104

Cover Page Interactive Data File (the cover page XBRL tags are embedded within the inline XBRL documents)

SIGNATURE

Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant 

0001533743
false

0001533743

2022-08-12
2022-08-12

iso4217:USD

xbrli:shares

iso4217:USD

xbrli:shares

UNITED
STATES

SECURITIES
AND EXCHANGE COMMISSION

WASHINGTON,
D.C. 20549

FORM
8-K

CURRENT
REPORT

Pursuant
to Section 13 or 15(d) of the

Securities
Exchange Act of 1934

Date
of Report (Date of earliest event reported): August 12, 2022

PROCESSA
PHARMACEUTICALS, INC.

(Exact
Name of Registrant as Specified in its Charter)

Delaware

001-39531

45-1539785

(State
or Other Jurisdiction

of Incorporation)

(Commission

File Number)

(IRS
Employer

Identification No.)

7380
Coca Cola Drive, Suite 106, Hanover, Maryland

21076

(Address
of Principal Executive Offices)

(Zip
Code)

Registrant’s
telephone number, including area code: (443) 776-3133

Not
Applicable

(Former
Name or Former Address, if Changed Since Last Report)

Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions:

☐
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities
registered pursuant to Section 12(b) of the Act:

Title
of each class

Trading
Symbol(s)

Name
of each exchange on which registered

Common
Stock, $0.0001 par value per share

PCSA

The
Nasdaq Stock Market LLC

Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging
growth company ☐

If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item
2.02. Results of Operations and Financial Condition.

On
August 12, 2022, we issued a press release announcing earnings and other financial results for the quarter ended June 30, 2022. The full
text of the press release is furnished as Exhibit 99.1 along with a Product Development Clinical Update Presentation as Exhibit
99.2. to this Current Report on Form 8-K.

The
information in this Current Report on Form 8-K (including Exhibit 99.1 and 99.2) shall not be deemed “filed” for
purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject
to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933,
as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item
9.01. Financial Statements and Exhibits.

Exhibit

No.

Description

99.1

Press Release issued on August 12, 2022 (furnished and not filed for purposes of Item 2.02)

99.2

Processa Product Development Clinical Update Presentation (furnished and not filed for purposes of Item 2.02)

104

Cover Page Interactive Data File (the cover page XBRL tags are embedded within the inline XBRL documents)

SIGNATURES

Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.

PROCESSA
PHARMACEUTICALS, INC.

Date:
August 12, 2022
By:
/s/
David Young

David
Young

Chief
Executive Officer

0001533743
false

0001533743

2021-08-12
2021-08-12

iso4217:USD

xbrli:shares

iso4217:USD

xbrli:shares

UNITED
STATES

SECURITIES
AND EXCHANGE COMMISSION

WASHINGTON,
D.C. 20549

FORM
8-K

CURRENT
REPORT

Pursuant
to Section 13 or 15(d) of the

Securities
Exchange Act of 1934

Date
of Report (Date of earliest event reported): August 12, 2021

PROCESSA
PHARMACEUTICALS, INC.

(Exact
Name of Registrant as Specified in its Charter)

Delaware

001-39531

45-1539785

(State
or Other Jurisdiction

of Incorporation)

(Commission

File Number)

(IRS
Employer

Identification No.)

7380
Coca Cola Drive, Suite 106, Hanover, Maryland

21076

(Address
of Principal Executive Offices)

(Zip
Code)

Registrant’s
telephone number, including area code: (443) 776-3133

Not
Applicable

(Former
Name or Former Address, if Changed Since Last Report)

Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions:

☐
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities
registered pursuant to Section 12(b) of the Act:

Title
of each class

Trading
Symbol(s)

Name
of each exchange on which registered

Common
Stock, $0.0001 par value per share

PCSA

The
Nasdaq Stock Market LLC

Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging
growth company ☐

If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item
2.02. Results of Operations and Financial Condition.

On
August 12, 2021, we issued a press release announcing the earnings and other financial results for the quarter ended June 30, 2021. The
full text of the press release is furnished as Exhibit 99.1 along with a Product Development Clinical Update Presentation as Exhibit
99.2. to this Current Report on Form 8-K.

The
information in this Current Report on Form 8-K (including Exhibit 99.1 and 99.2) shall not be deemed “filed” for purposes
of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities
of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the
Exchange Act, except as expressly set forth by specific reference in such a filing.

Item
9.01. Financial Statements and Exhibits.

Exhibit

No.

Description

99.1

Press Release issued on August 12, 2021 (furnished and not filed for purposes of Item 202)

99.2

Processa Product Development Clinical Update Presentation (furnished and not filed for purposes of Item 202)

SIGNATURES

Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.

PROCESSA
PHARMACEUTICALS, INC.

Date:
August 12, 2021
By:
/s/
David Young

David
Young

Chief
Executive Officer

8-K
1
form8-k.htm

UNITED
STATES

SECURITIES
AND EXCHANGE COMMISSION

WASHINGTON,
D.C. 20549

FORM
8-K

CURRENT
REPORT

Pursuant
to Section 13 or 15(d) of the

Securities
Exchange Act of 1934

Date
of Report (Date of earliest event reported): May 13, 2021

PROCESSA
PHARMACEUTICALS, INC.

(Exact
Name of Registrant as Specified in its Charter)

Delaware

001-39531

45-1539785

(State
or Other Jurisdiction
of Incorporation)

(Commission
File Number)

(IRS
Employer
Identification No.)

7380
Coca Cola Drive, Suite 106, Hanover, Maryland

21076

(Address
of Principal Executive Offices)

(Zip
Code)

Registrant’s
telephone number, including area code: (443) 776-3133

Not
Applicable

(Former
Name or Former Address, if Changed Since Last Report)

Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions:

[  ]
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

[  ]
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

[  ]
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

[  ]
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities
registered pursuant to Section 12(b) of the Act:

Title
of each class

Trading
Symbol(s)

Name
of each exchange on which registered

Common
Stock, $0.0001 par value per share

PCSA

The
Nasdaq Stock Market LLC

Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging
growth company [  ]

If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [  ]

Item 2.02.
Results
of Operations and Financial Condition.

On
May 13, 2021, we issued a press release announcing earnings and other financial results for the quarter ended March 31, 2021. The full
text of the press release is furnished as Exhibit 99.1 along with a Product Development Clinical Update Presentation as Exhibit 99.2.
to this Current Report on Form 8-K.

The
information in this Current Report on Form 8-K (including Exhibit 99.1 and 99.2) shall not be deemed “filed” for purposes
of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities
of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the
Exchange Act, except as expressly set forth by specific reference in such a filing.

Item
9.01. Financial Statements and Exhibits.

Exhibit
No.

Description

99.1

99.2

Press Release issued on November 2, 2020 (furnished and not filed for purposes of Item 202)

Processa Product Development Clinical Update Presentation (furnished and not filed for purposes of Item 202)

SIGNATURES

Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.

PROCESSA
PHARMACEUTICALS, INC.

Date:
May 13, 2021
By:
/s/
David Young

David
Young

Chief
Executive Officer

8-K
1
form8-k.htm

UNITED
STATES

SECURITIES
AND EXCHANGE COMMISSION

WASHINGTON,
D.C. 20549

FORM
8-K

CURRENT
REPORT

Pursuant
to Section 13 or 15(d) of the

Securities
Exchange Act of 1934

Date
of Report (Date of earliest event reported): March 25, 2021

PROCESSA
PHARMACEUTICALS, INC.

(Exact
Name of Registrant as Specified in its Charter)

Delaware

001-39531

45-1539785

(State
or Other Jurisdiction
of Incorporation)

(Commission
File Number)

(IRS
Employer
Identification No.)

7380
Coca Cola Drive, Suite 106, Hanover, Maryland

21076

(Address
of Principal Executive Offices)

(Zip
Code)

Registrant’s
telephone number, including area code: (443) 776-3133

Not
Applicable

(Former
Name or Former Address, if Changed Since Last Report)

Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant
under any of the following provisions:

[  ]
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

[  ]
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

[  ]
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

[  ]
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities
registered pursuant to Section 12(b) of the Act:

Title
of each class

Trading
Symbol(s)

Name
of each exchange on which registered

Common
Stock, $0.0001 par value per share

PCSA

The
Nasdaq Stock Market LLC

Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging
growth company [  ]

If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for
complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [  ]

Item
2.02. Results of Operations and Financial Condition.

On
March 25, 2021, we issued a press release announcing earnings and other financial results for our fiscal quarter ended December
31, 2020, and that management would present these results in a conference call at 5:30 PM Eastern time on March 25, 2021. Incorporated
by reference is a press release and the presentation issued by the Registrant on March 25, 2021 attached as Exhibit 99.1 and 99.2.

Item
9.01. Financial Statements and Exhibits.

Exhibit
No.

Description

99.1

Press
Release issued on March 25, 2021

99.2

Presentation
dated March 25, 2021

SIGNATURES

Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf
by the undersigned hereunto duly authorized.

PROCESSA
PHARMACEUTICALS, INC.

Date:
March 25, 2021
By:
/s/
David Young

David
Young

Chief
Executive Officer