Processa Pharmaceuticals (NASDAQ: PCSA), a developer of next-generation chemotherapy drugs that provide a better safety-efficacy profile than widely used FDA-approved counterparts, is reporting on its full-year 2022 financial results and has also noted key accomplishments for the year. According to the announcement, PCSA will be focusing on the development of its next-generation chemotherapy drugs this year as well as out-licensing/business development efforts for non-oncology assets. The report also noted that dose escalations continue for the company’s Next Generation Capecitabine with no observed adverse events associated with the catabolites of capecitabine. The company also anticipates discussions with the FDA beginning in April regarding a Next Generation Capecitabine phase 2B trial and overall development following the agency’s Project Optimus initiative. The company reported a cash balance of $6.5 million on Dec. 31, 2022, and stated that, subsequent to year-end, it raised net proceeds of $6.4 million from the sale of 8,432,192 shares of common stock through a combination of financing vehicles, including a registered direct offering to accredited investors. The report stated that the cumulative $12.9 million will fund company operations into the third quarter of 2024. In addition, net loss for the year was $27.4 million, an increase from the same period the year before, primarily due to a one-time noncash impairment of an intangible asset for $7.3 million, along with increased stock-based compensation and clinical trial costs. The company incurred $11.5 million in research and development costs with general and administrative expenses totaling $8.8 million for the year. “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,” said Processa Pharmaceuticals president and CEO Dr. David Young in the press release. “Today, we are focusing our energy and efforts on the next-generation chemotherapies (“NGCs”) that can reshape the landscape of chemotherapy.”
To view the full press release, visit https://ibn.fm/knBk0
About Processa Pharmaceuticals Inc.
Processa Pharmaceuticals has a mission 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 lives. 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, 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.
NOTE TO INVESTORS: The latest news and updates relating to PCSA are available in the company’s newsroom at https://ibn.fm/PCSA
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