8-K
Processa Pharmaceuticals, Inc. (PCSA)
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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): March 30, 2023
Commission
file number 001-39531
PROCESSA
PHARMACEUTICALS, INC.
(Exactname 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<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 | PCSA | Nasdaq<br> 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<br> growth company ☐ |
|---|
| If<br> an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying<br> with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐ |
| --- |
Item2.02 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.
Item7.01 Regulation FD Disclosure.
CorporatePresentation
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.
Item9.01. 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<br> PHARMACEUTICALS, INC. | |
|---|---|
| Registrant | |
| By: | /s/ David Young |
| David<br> Young | |
| Chief<br> Executive Officer |
Exhibit99.1
ProcessaPharmaceuticals Provides Corporate Update and Announces Year End 2022 Financial Results
| ● | Companyfocused on the development of Next Generation Chemotherapy drugs in 2023 and out-licensing/business development efforts for non-oncologyassets. |
|---|---|
| ● | Dose escalations continue for Next Generation Capecitabine with no observed adverse events associated with the catabolites of capecitabine. |
| ● | FDA discussions mid-April on Next Generation Capecitabine Phase 2B trial and overall development following Project Optimus initiative |
HANOVER, MD., March 30, 2023 (GLOBE NEWSWIRE) — Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (“Processa” or the “Company”), a developer of Next Generation Chemotherapy drugs that provide a better safety-efficacy profile than their widely used
FDA-approved counterparts, today provided an update on their clinical programs and announced financial results for the year ended December 31, 2022.
Dr. David Young, President and CEO of Processa, commented, “We completed a successful Phase 2A trial of PCS12852 in patients with gastroparesis, positioning the asset well for potential out-licensing or business development opportunities. Today, we are focusing our energy and efforts on the Next Generation Chemotherapies (NGCs) that can reshape the landscape of chemotherapy.
Our first NGC to move into Phase 2B will be Next Generation Capecitabine (NGC-Cap). Since 50-70% of the patients on capecitabine typically have dose-limiting side effects, one major benefit of NGC-Cap is to significantly decrease or potentially eliminate these side effects, so patients do not need to reduce their dose or discontinue treatment entirely. As a safer and potentially more efficacious version of the presently used capecitabine, the target population for NGC-Cap includes patients with such cancers as colorectal, breast, pancreatic, and many other solid tumor cancers. These cancers have more than 200,000 newly diagnosed cases per year in the U.S. We look forward to meeting with the FDA in mid-April to discuss our NGC-Cap Phase 2B trial and hope to initiate the Phase 2B trial in colorectal cancer in the second half of 2023. Given we are working with an approved established cancer-killing molecule, and we will be following the principles of Project Optimus, we anticipate efficiencies in the development of NGC-Cap that we believe will confer better odds of success, while providing better and safer drugs to hundreds of thousands of patients in need of better treatment options.”
FinancialResults for the Year Ended December 31, 2022
Our cash balance on December 31, 2022, was $6.5 million. Subsequent to year-end, we raised net proceeds of $6.4 million from the sale of 8,432,192 shares of our common stock through a combination of financing vehicles, including a registered direct offering to accredited investors. Based on our current plans, we believe the cumulative $12.9 million will be adequate to fund our operations into the third quarter of 2024.
Our net loss for the year ended December 31, 2022 was $27.4 million, or $1.70 per share, compared to a net loss of $11.4 million, or $0.75 per share for the same period of 2021. The increase in our net loss was primarily due to a one-time non-cash impairment of an intangible asset for $7.3 million, along with increased stock-based compensation and clinical trial costs.
For the year ended December 31, 2022, we incurred $11.5 million in research and development costs, compared to $6.9 million for the same period in 2021. Our general and administrative expenses totaled $8.8 million for the year ended December 31, 2022 compared to $4.7 million for the same period in 2021. The increase was primarily due to stock-based and other compensation costs. During the year ended December 31, 2022, we allocated $8.8 million of total non-cash compensation costs between our R&D and G&A costs, with the majority being recorded as G&A.
We used cash of $9.6 million during the year ended December 31, 2022 to fund our three clinical trials and operations versus $8.8 million of cash we used in 2021. Our operating cash flow is significantly less than our net loss primarily due to non-cash expenses.
As of March 27, 2022, we had 24.6 million common shares 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: March 30, 2023
Time: 4:30 p.m. ET
Toll Free: 888-506-0062
International: 973-528-0011
Entry Code: 382258
Live Webcast: https://www.webcaster4.com/Webcast/Page/2572/47882
ConferenceCall Replay Information
Toll-free: 877-481-4010
International: 919-882-2331
Replay Passcode: 47882
Replay Webcast: https://www.webcaster4.com/Webcast/Page/2572/47882
AboutProcessa Pharmaceuticals, Inc.
The mission of Processa is to develop the Next Generation Chemotherapies (with existing clinical evidence of safety and efficacy) for cancer patients who need better cancer drugs to extend survival and/or improve their quality of life. The Company uses its Regulatory Science Approach and the principles of the FDA’s Project Optimus Oncology initiative to provide an efficient development program, increase the probability of approval, and provide a safer and better cancer treatment that can be easily differentiated from what is presently on the market and in development. Processa is developing three Next Generation Chemotherapy oncology treatments: Next Generation Capecitabine (PCS6422 and capecitabine to treat metastatic colorectal, gastrointestinal, breast, pancreatic, and other cancers), Next Generation Gemcitabine (PCS3117 to treat pancreatic, lung, ovarian, breast, and other cancers), and Next Generation Irinotecan (PCS11T to treat lung, colorectal, gastrointestinal, pancreatic, and other cancers).
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
301-651-4256
mfloyd@processapharma.com
Patrick Lin
(925) 683-3218
plin@processapharma.com
Exhibit 99.2
