On August 12, 2022 Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) ("Processa" or the "Company"), a clinical stage company developing drugs for patients who have unmet medical conditions and/or require better treatment options to improve a patient’s survival and/or quality of life, reported financial results for the quarter ended June 30, 2022, and provided an update on its clinical programs (Press release, Processa Pharmaceuticals, AUG 12, 2022, View Source [SID1234618246]).
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Dr. David Young, President and CEO of Processa, commented, "Our efforts to enhance enrollment through adding new sites, extensive marketing campaigns and working with our CRO partners are showing results:
We expect to close out enrollment for PCS12852 for Gastroparesis within the next month and present top-line data from the trial before the end of the year.
We now have a sufficient number of patients in the screening queue for PCS6422 to complete our interim cohorts which we believe will provide valuable insights on de novo formation of DPD. We anticipate we will determine the maximum tolerated dose by early 2023.
Patients are beginning to show a willingness to travel, and we are seeing increased patient activity in our PCS499 ulcerative necrobiosis lipoidica (uNL) trial. We are optimistic that we will enroll our interim analysis cohort before the end of the year.
As part of our efforts to increase enrollment on our PCS499 trial, we recently launched a website to increase awareness of uNL and to inform patients of the ongoing Phase 2B Study of PCS499.
Advancing these 3 drugs in their respective clinical trial allows us to obtain the clinical data to better define each pivotal trial as well as provide us with more insight into how FDA will review each of these products when we submit the New Drug Applications to FDA."
Financial Results for the Six Months Ended June 30, 2022
Our cash balance on June 30, 2022, was $12.1 million, which should be sufficient to complete our three on-going clinical trials and fund our operations into the third quarter of 2023. During the six months ended June 30, 2022, we spent $4.1 million in cash for these three clinical trials and our operations. This is significantly less than our GAAP net loss of $8.4 million due to the effect of non-cash items like amortization and stock-based compensation, and the application of amounts we had prepaid to our CROs last year.
Our net loss for the six months ending on June 30, 2022, was $8.4 million or $0.53 per share compared to a net loss of $5.3 million, or $0.35 per share for the same period of 2021. The increase in our net loss relates primarily to increased clinical trial costs we incurred in our three ongoing trials. For the six months ended June 30, 2022, we incurred $5.2 million in research and development costs, an increase of $2.1 million when compared to the same period of 2021. We anticipate clinical trial costs will continue to increase for the rest of the year as our trials continue to progress and we fund development activities for the other drugs in our pipeline.
During the six months ending June 30, 2022, our general and administrative expenses totaled $3.2 million compared to $2.1 million for the same period in 2021. The increase related primarily to increases in non-cash or stock-based compensation costs, along with other operating and consulting costs. We allocated $2.8 million of non-cash compensation costs between our R&D and G&A costs, with the majority recorded as G&A.
Our net cash used in operating activities during the six months ended June 30, 2022, decreased by $300,000 to $4.1 million, compared to $4.4 million for the same period in 2021. While we experienced increased GAAP costs related to our clinical trials and operations, we continued to make use of equity incentives to compensate our executive and development team, thereby reducing our cash outflow, and we were able to apply previously made advanced payments to our CROs against current trial costs.
As of June 30, 2022, we had 15.8 million common shares outstanding.
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