On March 31, 2023 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, reported an update on their clinical programs and announced financial results for the year ended December 31, 2022 (Press release, Processa Pharmaceuticals, MAR 31, 2023, View Source [SID1234629670]).

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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."

Financial Results 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.

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Date: March 30, 2023
Time: 4:30 p.m. ET
Toll Free: 888-506-0062
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Entry Code: 382258
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