8-K
Processa Pharmaceuticals, Inc. (PCSA)
View as plain text
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
Dateof Report (Date of earliest event reported): May 12, 2022
PROCESSA
PHARMACEUTICALS, INC.
(ExactName of Registrant as Specified in its Charter)
| Delaware | 001-39531 | 45-1539785 |
|---|---|---|
| (State or Other Jurisdiction<br><br> <br>of Incorporation) | (Commission<br><br> <br>File Number) | (IRS Employer<br><br> <br>Identification No.) |
7380Coca Cola Drive, Suite 106,
Hanover,Maryland, 27106
(Addressof Principal Executive Offices) (Zip Code)
Registrant’stelephone number, including area code: (443) 776-3133
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<br> communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting<br> material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement<br> communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement<br> 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<br> of each class | Trading<br> Symbol(s) | Name<br> of each exchange on which registered |
|---|---|---|
| Common<br> Stock, $0.0001 par value per share | PCSA | The<br> 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. ☐
Item7.01. Regulation FD Disclosure.
On May 12, 2022, Processa Pharmaceuticals, Inc. (the “Company”) issued a press release announcing the earnings and other financial results for the quarter ended March 31, 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, except as expressly set forth by specific reference in such a filing.
Item9.01. Financial Statements and Exhibits.
| Exhibit<br><br> No. | Description |
|---|---|
| 99.1 | Press<br> Release issued on May 12, 2022 (furnished and not filed for purposes of Item 202) |
| 99.2 | Processa<br> Product Development Clinical Update Presentation (furnished and not filed for purposes of Item 202) |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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:<br> May 12, 2022 | By: | /s/ David Young |
| David<br> Young | ||
| Chief<br> Executive Officer |
Exhibit99.1
ProcessaPharmaceuticals Announces First Quarter 2022 Financial Results and Provides Corporate Update
| ● | Amended Next Generation Capecitabine study has restarted which will elucidate timelines for de novo formation of DPD |
|---|---|
| ● | Expanded efforts for enrollment in PCS499 |
| ● | PCS12852 on target to complete enrollment by Q3 |
HANOVER, Md., May 12, 2022 (GLOBE NEWSWIRE) — Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (“Processa” or the “Company”), a clinical stage company developing drugs for patients who have unmet medical conditions that require better treatment options to improve a patient’s survival and/or quality of life, today announced financial results for the quarter ended March 31, 2022, and provided an update on its clinical programs.
Dr. David Young, CEO and chairman of Processa, commented, “We are on track to get important data from all our clinical programs over the remainder of this year that will elucidate the path to registration for these programs that each have a market that could exceed $1 billion.
| ● | The<br> amended protocol for Next Generation Capecitabine will provide insights into the de novo formation of DPD by mid-summer and allow<br> us to get to the MTD by year-end; |
|---|---|
| ● | Our<br> expanded outreach to find and enroll patients in the PCS499 uNL trial has identified new potential patients to complete enrollment<br> for our interim analysis cohort mid-summer and interim results by year-end; |
| ● | Enrollment<br> in PCS12852 is going well and is expected to fully enroll patients and provide top line results before the end of the year; and |
| ● | We<br> expect to complete the initial development on the macromolecule assays that will be evaluated as potential biomarkers for PCS3117<br> and confirm our Regulatory Path with FDA by the end of the year.” |
FinancialResults for the Quarter Ended March 31, 2022
We continue to manage our cash efficiently and had a cash balance of $14.4 million at March 31, 2022. We believe this will allow us to complete our three on-going clinical trials and fund our operations into the third quarter of 2023. During the three months ending on March 31, 2022 we spent cash of $1.8 million in our clinical trials and operations.
For the three months ended March 31, 2022, we reported a net loss of $3.2 million, or $0.20 per share compared to a net loss of $2.1 million, or $0.14 per share for the same period of 2021. The increase in our net loss relates primarily to increased clinical trial costs we incurred.
During the three months ended March 31, 2022, we incurred research and development expenses totaling $2.0 million compared to $1.5 million for the same period in 2021. The increase in our R&D expenditures was primarily due to costs we incurred in our active clinical trials. Our general and administrative expenses totaled $1.2 million for the three months ended March 31, 2022 compared to $717 thousand for the same period in 2021. The increase related primarily to increases in non-cash stock-based compensation along with other operating and consulting costs. We allocated $829 thousand of non-cash compensation costs between our R&D and G&A expenses.
As of March 31, 2022, we had 15.8 million shares of common stock outstanding.
ConferenceCall Information
To participate in this event, please log-on or dial-in approximately 5 to 10 minutes before the beginning of the call.
Date: May 12, 2022
Time: 4:30 p.m. ET
Toll Free: 877-545-0320
International: 973-528-0002
Entry Code: 896576
Live Webcast: https://www.webcaster4.com/Webcast/Page/2572/45432
ConferenceCall Replay Information
Toll-free: 877-481-4010
International: 919-882-2331
Replay Passcode: 45432
Replay Webcast: https://www.webcaster4.com/Webcast/Page/2572/45432
AboutProcessa Pharmaceuticals, Inc.
The mission of Processa is to develop products with existing clinical evidence of efficacy for patients with unmet or underserved medical conditions who need treatment options that improve survival and/or quality of life. The Company uses these criteria for selection to further develop its pipeline programs to achieve high-value milestones effectively and efficiently. Active clinical pipeline programs include: Next Generation Capecitabine (formerly identified as PCS6422) for metastatic colorectal cancer and breast cancer, PCS499 for ulcerative necrobiosis lipoidica and PCS12852 for gastroparesis. The members of the Processa development team have been involved with more than 30 drug approvals by the FDA (including drug products targeted to orphan disease conditions) and more than 100 FDA meetings throughout their careers. For more information, visit the company’s website at www.processapharma.com.
Forward-LookingStatements
This release contains forward-looking statements. The statements in this press release that are not purely historical are forward-looking statements which involve risks and uncertainties. Actual future performance outcomes and results may differ materially from those expressed in forward-looking statements. Please refer to the documents filed by Processa Pharmaceuticals with the SEC, specifically the most recent reports on Forms 10-K and 10-Q, which identify important risk factors which could cause actual results to differ from those contained in the forward-looking statements.
For More Information:
Michael Floyd
mfloyd@processapharma.com
(301)651-4256
Patrick Lin
(925) 683-3218
plin@processapharma.com
Exhibit 99.2
