Processa Pharmaceuticals, Inc.
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Range $225 – $225
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About the company
Processa Pharmaceuticals, Inc. is a biopharmaceutical company in the clinical development stage, committed to identifying and progressing therapeutic agents for patients with critical unmet medical requirements throughout the United States. The company's leading investigational drug, PCS499, is an oral tablet presently undergoing Phase 2B clinical assessment.
- CEO
- George K. Ng
- IPO
- 2014
- Employees
- 12
- HQ
- Vero Beach, FL, US
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- Market Cap
- $4.21M
- P/E
- -0.27
- PEG
- -0.00
- P/S
- 0.00
- P/B
- -13.18
- EV/EBITDA
- -0.30
- Div Yield
- 0.00%
- Gross Margin
- 0.00%
- Op Margin
- 0.00%
- Net Margin
- 0.00%
- ROE
- -394.24%
- ROIC
- 4051.82%
Latest fiscal year · YoY change
- Revenue
- $0+0.0%
- Gross Profit
- $0+0.0%
- Op Income
- $-13,988,505
- Net Income
- $-13,563,834-14.5%
- EPS
- $-10.36+89.3%
- OCF Growth
- -1.2%
- FCF Growth
- -1.2%
- 52W High
- $14.25
- 52W Low
- $1.45
- 50D MA
- $2.09
- 200D MA
- $2.54
- Beta
- 0.97
- RSI (14)
- 32
- Avg Volume
- 226.09K
Earnings call summaries
Pick a quarter — each call distilled into takeaways, results, and a bull vs bear read.
Processa ended 2022 with a larger net loss and higher spending, but said its cash plus a post-year-end raise fund operations into Q3 2024 while it narrows its pipeline to three oncology programs.· March 30, 2023
- Cash was $6.5 million at Dec. 31, 2022, and a subsequent $6.4 million equity raise lifted total available funds to $12.9 million, expected to fund operations into third quarter 2024.
- GAAP net loss widened to $27.4 million, or $1.70 per share, from $11.4 million, or $0.75 per share, in 2021, driven by a $7.3 million intangible impairment, higher stock comp, and clinical trial costs.
- R&D rose to $11.5 million from $6.9 million, while G&A increased to $8.8 million from $4.7 million, reflecting more stock-based compensation and payroll costs.
- Management is prioritizing three next-generation oncology drugs and de-emphasizing the rest of the portfolio to focus capital and development effort.
- Key 2023 milestones include an FDA meeting in mid-April for next-gen capecitabine, a mid-2023 FDA meeting for next-gen gemcitabine, and IND-enabling work for next-gen irinotecan.
- results
- Processa reported no revenue as a pre-revenue company. Cash was $6.5 million at Dec. 31, 2022; after year-end it raised $6.4 million from the sale of 8.4 million shares, and management said the combined $12.9 million should fund active clinical trials and operations into the third quarter of 2024. For 2022, operating cash used was $9.6 million versus $8.8 million in 2021. GAAP net loss was $27.4 million, or $1.70 per share, versus $11.4 million, or $0.75 per share, in 2021. R&D expense was $11.5 million versus $6.9 million in 2021, and G&A was $8.8 million versus $4.7 million in 2021. The company did not give formal revenue or EPS guidance.
- ceo
- Dr. David Young said the company decided it would be better to focus on a few drugs rather than a five-drug portfolio, so in early 2023 it prioritized three oncology assets it calls next-generation chemotherapy drugs. He framed the strategy around using established cancer drugs in a better way rather than inventing entirely new targets, emphasizing fewer side effects, potentially better efficacy, and a regulatory-science approach aligned with FDA Project Optimus. His tone was confident and explanatory, but also candid that the team is aware of the stock’s underperformance and is focused on actions they believe can create value.
- cfo
- Jim Stanker highlighted that Processa remains pre-revenue and is managing cash carefully to advance the pipeline. He said year-end cash was $6.5 million, the post-year-end raise added $6.4 million, and the combined $12.9 million should be enough to complete active clinical trials and fund operations into Q3 2024. He also noted that operating cash used in 2022 was $9.6 million, up $800,000 from 2021, and that the gap between cash use and the $27.4 million GAAP net loss was largely due to non-cash items, including a $7.3 million impairment and $8.8 million of non-cash compensation.
- qanda
- Analysts focused mainly on how Processa’s Project Optimus approach will affect dosing and study design for next-gen capecitabine, and on the timing and readout expectations for the 300 mg cohort. Management said the mid-April FDA meeting is meant to align on the Phase 2b design and dosing regimen, likely including three to four groups and possibly a control arm. On 300 mg enrollment, management said it expects to finish in the next month or two, but exact Phase 2b dosing still depends on safety data and further FDA discussion. Questions also covered biomarker work for 3117 and next-gen irinotecan; management said biomarker analysis is still in the analytical stage and that irinotecan’s dose was being adjusted without changing timing, while details such as selectivity numbers were not yet disclosed.
- bull
- The company has a cleaner strategic focus now, concentrating on three oncology programs where management believes it has a regulatory and scientific edge. Management repeatedly said the next-generation chemotherapy approach could improve tolerability and efficacy, and cited upcoming FDA interactions as key catalysts. The balance sheet was also strengthened by the post-year-end financing, which management said extends runway into 2024.
- bear
- The quarter showed a much larger net loss and higher operating expenses, and the company remains pre-revenue. Several important details are still unresolved, including the exact Phase 2b dosing regimen, trial design, and eventual cost, all of which depend on FDA feedback. Management also noted ongoing uncertainty around biomarker validation for 3117 and that some programs, including 499, have already been discontinued because of enrollment problems.
AI summary of the company's earnings call · Paraphrased · Not investment advice
- Free Float
- 84.5%
- Shares Outstanding
- 2.77M
- Float Shares
- 2.34M
of shares held by institutions
20 13F filers
Buy/sell ratio 0.00. Sells can include pre-scheduled 10b5-1 plan sales, not just discretionary selling.
Held by 6 ETFs
Biggest fund positions in PCSA by dollar value.
Recent insider transactions
Who's buying, who's selling, and how much.
| Date | Insider | Type | Shares |
|---|---|---|---|
| Aug 8, 26 | Ng George K | other | 1,600 |
| Aug 8, 26 | Ng George K | other | 1,600 |
| Jul 28, 26 | GUJRATHI SHEILA | other | 70,811.877 |
| Jul 28, 26 | GUJRATHI SHEILA | other | 12,311.279 |
| Jul 28, 26 | GUJRATHI SHEILA | other | 0 |
| Jul 26, 26 | Yorke Justin W | other | 33,500 |
| Jul 26, 26 | SKIBSTED RUSSELL | other | 11,883 |
| Jul 26, 26 | Pannu Geraldine | other | 33,500 |
| Jul 26, 26 | Ng George K | other | 9,384 |
| Jul 26, 26 | Neal James R | other | 62,221 |
A “Sell” may be a pre-scheduled 10b5-1 plan sale rather than a discretionary decision — read insider selling with that in mind.
Our PCSA coverage
Recent articles, reports, and earnings notes.
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globenewswire.com · Jul 29
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defenseworld.net · Apr 4
Processa Pharmaceuticals to Attend 44th Annual J.P. Morgan Healthcare Conference
globenewswire.com · Jan 12
Processa Pharmaceuticals Completes Enrollment of 20th Patient for Formal Interim Analysis in Phase 2 NGC-Cap Breast Cancer Study
globenewswire.com · Jan 5
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