HANOVER, MD - Processa Pharmaceuticals, Inc. (NASDAQ:PCSA), a clinical-stage pharmaceutical company, has announced its plans to initiate a Phase 2 trial for its Next Generation Capecitabine (NGC-Cap) in the treatment of advanced or metastatic breast cancer. The decision follows a meeting with the U.S. Food and Drug Administration (FDA), which agreed that existing data from past studies could be used to support this new trial.
The FDA's acknowledgment provides Processa with a more streamlined path to potential approval, as the data already gathered will directly contribute to the Phase 2 breast cancer trial design. David Young, PharmD, Ph.D., President of Research and Development at Processa, stated that targeting breast cancer aligns with the company's strategic goals due to the larger market size compared to colorectal cancer and the opportunity to distinguish NGC-Cap from current treatments.
The company has identified key opinion leaders in breast cancer to join its scientific advisory board and has outlined the Phase 2 study design, which will soon be shared with the FDA. Processa plans to launch the Phase 2 study in the third quarter of 2024.
Breast cancer is the most commonly diagnosed cancer, with approximately 15% of all new cancer diagnoses in 2023. With a prevalence of over 3.8 million patients and nearly 300,000 new cases last year, the market potential for NGC-Cap spans breast, colorectal, and other cancers, potentially affecting over 250,000 patients annually.
NGC-Cap is a combination therapy that includes PCS6422, an irreversible dihydropyrimidine dehydrogenase (DPD) enzyme inhibitor, and lower doses of the chemotherapy drug Capecitabine. The treatment is designed to reduce side effects and improve the distribution of the active cancer-killing molecules to cancer cells.
Processa's development approach is based on a Regulatory Science Approach and aims to improve the safety and efficacy of cancer treatments. The company's pipeline includes modifications of existing FDA-approved oncology drugs, which are expected to result in fewer side effects and a more significant cancer response.
This expansion into breast cancer treatment is part of Processa's broader strategy to develop Next Generation Chemotherapy drugs, with the aim of providing better therapy options for cancer patients and increasing the likelihood of FDA approval. The information regarding this development is based on a press release statement from Processa Pharmaceuticals.
InvestingPro Insights
In light of Processa Pharmaceuticals' recent announcement regarding the Phase 2 trial for NGC-Cap in breast cancer treatment, a glance at the company's financial health and stock performance may offer additional context for investors. According to InvestingPro data, Processa holds a market capitalization of just $5 million, reflecting a small-cap status that often comes with higher risk and potential for volatility. This is further underscored by the company's price volatility, with a significant 22.78% drop in the price total return over the last week and a 60.89% drop over the last month.
Furthermore, Processa's financials indicate that the company is not currently profitable, with an adjusted P/E ratio for the last twelve months as of Q3 2023 standing at -0.33. The company's operating income during the same period was a negative $14.79 million, which aligns with one of the InvestingPro Tips that highlights Processa's quick cash burn rate. Additionally, analysts do not anticipate the company will be profitable this year, which investors should consider when evaluating the stock's growth prospects.
For those interested in a deeper dive into Processa's financials and stock performance, there are additional InvestingPro Tips available. Investors may find it noteworthy that while the company holds more cash than debt on its balance sheet, it suffers from weak gross profit margins and a valuation that implies a poor free cash flow yield. To explore these insights further and access a full suite of analytics, consider an InvestingPro+ subscription, now on a special New Year sale with discounts of up to 50%. Use coupon code ProW345 to get an additional 10% off a 2-year subscription. With these tools, investors can stay informed and make more data-driven decisions.
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