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HANOVER, Md. - Processa Pharmaceuticals, Inc. (NASDAQ:PCSA) has announced promising results from preclinical studies of its new drug candidate NGC-Iri, suggesting it could be a more effective and safer alternative to current FDA-approved cancer treatments irinotecan and Onivyde®. The studies focused on the drug's ability to deliver the cancer-fighting molecule SN-38 to tumors.
The preclinical research compared the accumulation of SN-38 in tumors and non-cancerous tissues after administering NGC-Iri, irinotecan, and Onivyde®. Results indicated that NGC-Iri led to significantly higher concentrations of SN-38 in tumors and lower levels in non-cancer tissues, such as muscle, which could imply a better safety profile.
David Young, PharmD, Ph.D., President of Research and Development at Processa, stated that the increased tumor exposure to SN-38 and reduced exposure to other tissues may enhance NGC-Iri's efficacy and side-effect profile. This could potentially offer an improved treatment option over irinotecan and Onivyde®, which are associated with significant side effects and carry black box warnings.
Irinotecan is widely used to treat various solid tumors, including colorectal, pancreatic, ovarian, and lung cancers, often in combination with other chemotherapy agents. Despite the severe side effects, Medicare reported over 1.8 million doses of irinotecan and Onivyde® administered in 2021.
NGC-Iri is designed to preferentially target cancer cells and extend the half-life of SN-38, the active molecule in both irinotecan and Onivyde®. Processa is now working to define the regulatory path for NGC-Iri, including identifying the target patient population and cancer type to present to the FDA.
Processa Pharmaceuticals is a clinical-stage company that specializes in developing next-generation chemotherapy drugs with an emphasis on safety and efficacy. Their strategy involves modifying existing FDA-approved oncology therapies to alter their metabolism and/or distribution.
The information reported is based on a press release statement, and further details will be provided by the company once the regulatory pathway and timeline are established.
In other recent news, Processa Pharmaceuticals has undergone a series of significant developments. H.C. Wainwright has revised its 12-month price target for Processa to $6, maintaining a Buy rating despite the company's recent Q2 financial results revealing a net loss of $1.01 per share. The firm projects a net loss of $3.78 per share for the full year of 2024, expected to narrow to a loss of $2.12 per share in 2025.
The U.S. Food and Drug Administration (FDA) has also cleared Processa's Investigational New Drug (IND) application, paving the way for a Phase 2 clinical trial of its lead product candidate, Next Generation Capecitabine (NGC-Cap), in patients with advanced or metastatic breast cancer. Initial data from the trial is expected by mid-2025.
In corporate shifts, Russell L. Skibsted has been appointed as the new Chief Financial Officer, succeeding the retiring James Stanker. Furthermore, Processa's shareholders have approved key proposals at its 2024 Annual Meeting, including the election of six directors and the amendment and restatement of the company's 2019 Omnibus Incentive Plan.
Finally, Processa reported promising preliminary results from a Phase 1b clinical trial of NGC-Cap for patients with advanced gastrointestinal tract cancer. The company plans to continue its investigation into two dosage regimens in a Phase 2 trial with breast cancer patients.
InvestingPro Insights
As Processa Pharmaceuticals, Inc. (NASDAQ:PCSA) continues to advance its clinical pipeline with promising drug candidates like NGC-Iri, financial metrics and market performance play a crucial role in the company's ability to sustain its research and development efforts. According to real-time data from InvestingPro, Processa holds a market capitalization of $4.14 million, indicating a relatively small player within the pharmaceutical industry. This size can impact the company's resources for extensive clinical trials and drug development.
InvestingPro Tips suggest that Processa has more cash than debt on its balance sheet, which is a positive sign for the company's financial health, especially when considering the cash-intensive nature of drug development. However, it is also quickly burning through cash, which raises concerns about long-term financial sustainability without additional funding or revenue streams. The company's weak gross profit margins and the analysts' anticipation that the company will not be profitable this year further highlight the financial challenges faced by Processa.
The company's stock price has also seen significant declines, with a year-to-date price total return of -78.33% and a one-year price total return of -80.67%. These figures represent the stock's performance and investor sentiment, which could be influenced by the company's financial health and the prospects of its drug pipeline. Notably, Processa does not pay a dividend, which may affect its attractiveness to income-focused investors. For investors seeking comprehensive analysis, InvestingPro offers additional insights, with 10 more InvestingPro Tips available at: https://www.investing.com/pro/PCSA.
These financial insights are crucial for investors who are considering the potential of Processa's drug development success against the backdrop of its current financial position and market performance. As the company navigates the regulatory path for NGC-Iri, these metrics will continue to be an important part of the conversation for stakeholders and potential investors alike.
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