Processa Pharmaceuticals, Inc. - Common Stock (PCSA)

Processa Pharmaceuticals (NASDAQPCSA), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs with improved efficacy and safety, reported that dosing of the first patient in its phase 2 clinical trial evaluating NGC-Cap has begun. The clinical trial is evaluating NGC-Cap for the treatment of advanced or metastatic breast cancer. NGC-Cap combines the administration of PCS6422, PCSA’s irreversible dihydropyrimidine dehydrogenase (“DPD”) enzyme inhibitor, with low doses of capecitabine.

Processa Pharmaceuticals (NASDAQPCSA) is a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs with improved efficacy and safety. The company today announced that management will hold one-on-one meetings with investors and deliver a company presentation at the H.C. Wainwright 26th Annual Global Investment Conference, scheduled for September 9-11, 2024, at the Lotte New York Palace Hotel. The recorded presentation will be available on demand beginning Monday, September 9, 2024, at 7 a.m. ET. In addition, Processa’s management will hold meetings with clinicians, researchers, industry key opinion leaders and potential partners at the European Society for Medical Oncology (“ESMO”) Congress 2024. ESMO Congress 2024 will be held September 13-17, 2024, in Barcelona.

Processa Pharmaceuticals (NASDAQPCSA), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs with improved efficacy and safety, today provided updates on its product pipeline, upcoming milestones and business activities. According to the updates, a Phase 2 trial with NGC-Cap is underway in patients with breast cancer. In addition, preclinical studies showed that NGC-Iri delivers more cancer-killing SN-38 molecules to the tumor than Onivyde(R) or irinotecan.

Processa Pharmaceuticals (NASDAQPCSA), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs with improved efficacy and safety, today announced positive data from two preclinical studies. The data support the potential for the Next Generation irinotecan (“NGC-Iri”), the prodrug of SN-38, which is the active anticancer metabolite of irinotecan, to have improved efficacy and a better side effect profile compared with the commonly used FDA-approved cancer treatments irinotecan and Onivyde(R) (the liposomal formation of irinotecan). The two studies demonstrated that NCG-Iri delivered more cancer-killing SN-38 molecules to the tumor than irinotecan and Onivyde(R). In addition, less SN-38 accumulated in non-cancer tissues, such as muscle, after NGC-Iri administration than after irinotecan or Onivyde(R) administration.

Processa Pharmaceuticals (NASDAQPCSA), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs with improved efficacy and safety, today announced that it has received approval from the U.S. Food and Drug Administration (“FDA”) for its Investigational New Drug (“IND”) application for its lead product candidate, Next Generation Capecitabine (“NGC-Cap”). According to the announcement, the FDA clearance enables the commencement of a Phase 2 clinical trial in patients with advanced or metastatic breast cancer. The Phase 2 study, which is expected to begin enrollment this quarter, will be a global multicenter, open-label, adaptive design trial comparing two different doses of NGC-Cap to FDA-approved monotherapy capecitabine in about 60 to 90 patients with advanced or metastatic breast cancer. “We are proud to achieve this significant milestone for NGC-Cap and look forward to entering the clinic for the treatment of advanced or metastatic breast cancer, where capecitabine is a standard of care. We previously demonstrated in our Phase 1b study that NGC-Cap is more potent than monotherapy capecitabine, providing up to 5-10 times more 5-fluorouracil exposure to cancer cells. This greater exposure resulted in a greater efficacy, with a safety profile better or similar to existing monotherapy with capecitabine,” said David Young, PharmD, Ph.D., President of Research and Development. “Initial data from the Phase 2 trial are expected mid-2025.”

Processa Pharmaceuticals (NASDAQPCSA), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs with improved efficacy and safety, has named a new chief financial officer. According to the announcement, Russell L. Skibsted has accepted the new assignment, effective immediately; Skibsted succeeds James Stanker, who is retiring but will serve in an advisory role to assist in the transition. Skibsted has spent almost three decades working in the pharmaceutical industry, gaining an invaluable expertise in financial management, global business development, capital markets, investor relations and operations. He has served in both public and private life sciences companies at all stages of development. His positions have included senior vice president and CFO at Alimera Sciences; executive vice president, CFO and chief business officer at Rockwell Medical; and CFO at BioTime, among others. “We are delighted to welcome Russell to Processa’s executive team,” said Processa Pharmaceuticals CEO George Ng in the press release. “His proven record in finance and capital markets combined with a deep understanding of the complexities inherent in the life sciences make him an ideal fit for Processa. With three decades of highly relevant experience, Russell is a seasoned executive and will be a tremendous asset to the company as we advance our pipeline through the clinic.”

Processa (NASDAQPCSA), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs with improved efficacy and safety, today announced positive efficacy results from the preliminary evaluation of its recently completed Phase 1b clinical trial. The trial defined the maximum tolerated dose (“MTD”) and recommended Phase 2 dose range (“RP2DR”) for Next Generation Capecitabine (“NGC-Cap”) administered to patients with stage III or IV gastrointestinal tract (“GI”) cancer. “We are encouraged by the preliminary efficacy analysis from our NGC-Cap Phase 1b dose-escalating safety/tolerability trial demonstrating some anti-tumor activity in patients with advanced GI cancer who have progressive cancer after relapsing or not responding to prior therapy. The favorable response is likely due to NGC-Cap’s ability to distribute more 5-FU to cancer cells than monotherapy capecitabine. The promising Phase 1b safety and tolerability profile plus these early efficacy signals provide validation for further development of NGC-Cap,” said David Young, PharmD, Ph.D., president of research and development at Processa. “From this Phase 1b trial, we have been able to define the MTD and the RP2DR to use in our Phase 2 Optimal Dosage Regimen trial in breast cancer in the third quarter of 2024.”

Processa Pharmaceuticals (NASDAQPCSA), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs with improved efficacy and safety, will be represented at this month’s EF Hutton Annual Global Conference. According to the announcement, key company officials will be attending the event, which will be held in New York City on May 15, 2024. Members of the Processa Pharmaceuticals management team will be meeting one-on-one with investors attending the event.

Processa (NASDAQPCSA) is a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs with improved efficacy and safety. The company today announced that it has named Steven Cha, M.D. as senior vice president of clinical research. In the newly created position, Dr. Cha’s experience as an oncologist as well as in oncology drug development will be important additions to Processa. “We are delighted to have Dr. Cha join our team to lead the clinical development of our three oncology programs. Steven has successfully guided multiple oncology therapies from early discovery through late-stage clinical development, regulatory approval and post-marketing commitments,” said George Ng, chief executive officer of Processa Pharmaceuticals. “His extensive relevant experience and outstanding leadership abilities will be valuable as we advance our programs in the clinic, with plans to initiate our NGC-Cap Phase 2 trial in breast cancer later this year.”

Processa Pharmaceuticals (NASDAQPCSA), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs to improve the efficacy and safety for more patients suffering from cancer, participated at this year’s annual American Association for Cancer Research (“AACR”). According to the announcement, the company presented two abstracts at the conference, including new phase 1b data on its Next Generation Capecitabine (“NGC-Cap”) product. The data indicated that NGC-Cap demonstrated greater 5-FU exposure than monotherapy capecitabine at a significantly lower dose with a favorable clinical safety profile, showing that NGC-Cap has potential for improved efficacy in more patients due to an increase in distribution of 5-FU to cancer cells. “The most recent data for the phase 1b NGC-Cap study presented at AACR highlight NGC-Cap’s ability to distribute more 5-FU to cancer cells with five to ten times greater systemic exposure than when capecitabine is administered alone,” said Processa Pharmaceuticals president of research and development David Young, PharmD, PhD, in the press release. “As expected with a higher systemic exposure, there was a greater incidence of adverse events with NGC-Cap. However, these adverse events were less dose limiting than seen with other 5-FU metabolites. This phase 1b study is ongoing due to continued patient response, and we plan to release final trial data once the database is locked. Given we have identified the recommended phase 2 doses and the maximum tolerated dose, we look forward to advancing NGC-Cap into a phase 2 trial in breast cancer later this year. As agreed to with the FDA, our data in past and ongoing studies will be used to support the breast cancer phase 2 trial, which streamlines the regulatory path for NCG-Cap.”

Processa (NASDAQPCSA) is a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs to improve the efficacy and safety for patients suffering from cancer. The company today announced that its CEO George Ng will present a corporate update at the MedInvest Biotech and Pharma Investor Conference being held on April 3 – 4, 2024, in New York City. In addition, Ng will be available for in-person one-on-one meetings with registered investors, and David Young, Processa’s president of research and development, will participate virtually throughout the event. Processa’s presentation is scheduled to begin at 10:55 a.m. ET on April 3.

Processa (NASDAQPCSA) is a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs to improve the efficacy and safety for patients suffering from cancer. The company today announced that its CEO George Ng will present a corporate update at the MedInvest Biotech and Pharma Investor Conference being held on April 3 – 4, 2024, in New York City. In addition, Ng will be available for in-person one-on-one meetings with registered investors, and David Young, Processa’s president of research and development, will participate virtually throughout the event. Processa’s presentation is scheduled to begin at 10:55 a.m. ET on April 3.

Processa (NASDAQPCSA) is a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs to improve the efficacy and safety for patients suffering from cancer. The company today announced that it will have two posters at the American Association for Cancer Research Annual Meeting, which is taking place in San Diego from April 5-10, 2024. The announcement outlines session and display details for the posters that will be presented. In addition, Processa President of Research and Development David Young, PharmD, Ph.D. will be available during the allotted times and, along with Processa CEO George Ng, will be available for one-on-one meetings throughout the event.

Processa (NASDAQPCSA), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs to improve the efficacy and safety for patients suffering from cancer, today announced that its CEO George Ng will present a corporate update at the 2024 BIO CEO & Investor Conference. The event is slated to take place on Feb. 26 – 27, 2024, at the Marriott Marquis in New York City with Ng’s presentation scheduled to begin at 10 a.m. ET on Feb. 26. Interested parties should visit https://ibn.fm/lCCty to register for the conference.

Processa Pharmaceuticals (NASDAQPCSA), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs to improve the efficacy and safety for more patients suffering from cancer, has closed on its previously announced public offering. The offering, which closed on Jan. 30, 2024, was comprised of 1,555,555 shares of common stock (or prefunded warrants in lieu thereof) along with common warrants to purchase up to 1,555,555 shares of its common stock. The combined public offering price per share of common stock (or prefunded warrants in lieu thereof) and accompanying common warrant was $4.50. H.C. Wainwright & Co. LLC was the exclusive placement agent for the offering. “The common warrants have an exercise price of $4.50 per share, are immediately exercisable upon issuance and have a term of five years after their original issuance date,” stated the company in the press release. “The gross proceeds from the offering, before deducting placement agent fees and other offering expenses payable by the company, were $7 million (excluding any proceeds that may be received upon the exercise of the common warrants).”

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Processa Pharmaceuticals (NASDAQPCSA), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs to improve the efficacy and safety for more patients suffering from cancer, is announcing the pricing of its public offering. The offering is comprised of 1,555,555 shares of common stock (or prefunded warrants in lieu thereof) and common warrants to purchase up to 1,555,555 shares of its common stock. The combined public offering price per share of common stock (or prefunded warrants in lieu thereof) and accompanying common warrant is $4.50. H.C. Wainwright & Co. LLC is the exclusive placement agent for the offering. “The common warrants will have an exercise price of $4.50 per share, will be immediately exercisable upon issuance and have a term of five years after their original issuance date,” stated the company in the press release. “The gross proceeds from the offering, before deducting placement agent fees and other offering expenses payable by the company, are expected to be $7 million (excluding any proceeds that may be received upon the exercise of the common warrants). The offering is expected to close on or about Jan. 30, 2024, subject to the satisfaction of customary closing conditions.”

HANOVER, Md., Jan. 26, 2024 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (“Processa” or the “Company”), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs to improve the efficacy and safety for more patients suffering from cancer, announces the pricing of a public offering consisting of 1,555,555 shares of common stock (or pre-funded warrants in lieu thereof) and common warrants to purchase up to 1,555,555 shares of its common stock, at a combined public offering price per share of common stock (or per pre-funded warrants in lieu thereof) and accompanying common warrant of $4.50.

Processa Pharmaceuticals (NASDAQPCSA) is a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs to improve the efficacy and safety for more patients suffering from cancer. The company today announced successful completion of the safety tolerability evaluation in its Phase 1b trial of Next Generation Capecitabine (“NGC-Cap”). Two dosage regimens were selected for the Phase 2 trial, which will be in advanced or metastatic breast cancer given FDA’s agreement that the Phase 1b data can be used to support the design of the Phase 2 trial in breast cancer. “Processa is very grateful to the patients and their physicians who participated in this trial and have been instrumental in our reaching these impactful findings. We are encouraged that NGC-Cap in the Phase 1b trial was tolerated better than or similar to the existing FDA-approved capecitabine even though the exposure to NGC-Cap’s 5-FU cancer-treating metabolite was 2-10 times that of capecitabine,” said David Young, PharmD, Ph.D., president of research and development at Processa. “This greater exposure suggests that NGC-Cap can distribute more 5-FU to the cancer cells, potentially forming more cancer-killing metabolites that, in our small number of patients, has shown to improve the cancer-killing effect of NGC-Cap over capecitabine.”

Processa Pharmaceuticals (NASDAQPCSA), a clinical-stage pharmaceutical company developing the next generation of chemotherapeutic drugs, today announced plans to expand the development of Next Generation Capecitabine (“NGC-Cap”) into the treatment of advanced or metastatic breast cancer beginning with its next Phase 2 trial. NGC-Cap combines the administration of PCS6422, the company’s irreversible dihydropyrimidine dehydrogenase (“DPD”) enzyme inhibitor, with the administration of low doses of the commonly used chemotherapy capecitabine, which is already approved as both monotherapy and combination therapy in breast cancer. The decision to begin with a Phase 2 trial in breast cancer followed Processa’s meeting with the FDA, where it was agreed that pursuing breast cancer would lead to a more efficient development program while providing a greater likelihood of FDA approval. “We believe the pursuit of an advanced or metastatic breast cancer indication for NGC-Cap is a logical progression for Processa as it represents a larger market than colorectal cancer with the potential to differentiate NGC-Cap from the presently approved capecitabine as well as other treatments for breast cancer. The FDA and Processa discussed the advantages and disadvantages of developing NGC-Cap in breast cancer and concluded that the development would be a more efficient and straightforward path to approval with an easier enrollment process for the Phase 2 and 3 trials,” said David Young, PharmD, Ph.D., president of research and development at Processa.

Processa Pharmaceuticals (NASDAQPCSA), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs to improve the efficacy and safety for patients suffering from cancer, has announced a 1-for-20 reverse stock split. The reverse split was initially approved by shareholders in November 2023, and on Jan. 8, 2024, the company’s board of directors determined to fix a split ratio of 1-for-20. According to the announcement, PCSA common stock is slated to begin trading on a reverse stock split-adjusted basis at market opening on Jan. 22, 2024, under the same symbol: PCSA. The intention of the reverse stock split, the announcement noted, is for Processa Pharmaceuticals to regain compliance with the minimum bid price requirement of $1 per share of common stock so that the company can continue to trade on the NASDAQ Capital Market. The reverse stock split will reduce the number of shares of the company’s outstanding common stock from an estimated 24.6 million shares to an estimated 1.2 million shares. Registered stockholders holding shares of presplit PCSA common stock electronically in book-entry form don’t need to do anything in order to receive post-split shares of common stock. Stockholders with shares of common stock either in a brokerage or in “street name” will have their shares automatically adjusted to reflect the reverse stock split, subject to compliance with each broker’s particular processes. Continental Stock Transfer & Trust will serve as the exchange agent for the reverse stock split.

Processa Pharmaceuticals (NASDAQPCSA), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs to improve the efficacy and safety for patients suffering from cancer, will be featured at this month’s Biotech Showcase 2024. The premier event is slated for Jan. 8–10, 2024, in San Francisco. During the event, Processa CEO George Ng will be presenting a corporate overview, and members of the management team will be available for one-on-one meetings. Ng’s presentation is scheduled to begin at 4 p.m. PST on Jan. 8. A replay of the presentation will be available on the company website as well.

Processa Pharmaceuticals (NASDAQPCSA) is a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs to improve the safety and efficacy for more cancer patients. Today the company provided an interim analysis from its phase 1b study of its Next Generation Capecitabine (“NGC-Cap”). “These initial data provide our first confirmatory clinical evidence that NGC-Cap is metabolized differently than capecitabine and, as a result, may offer significant improvements in safety and efficacy over capecitabine, a commonly used chemotherapeutic agent across multiple cancer indications,” said David Young, Pharm.D., Ph.D., president of research and development at Processa. “We are encouraged to be near completion of the phase 1b trial as we make preparations for a subsequent phase 2 trial with NGC-Cap.”

Processa Pharmaceuticals (NASDAQPCSA) is a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs to improve the efficacy and safety for more patients suffering from cancer. The company today announced the outcomes from a successful meeting with the U.S. Food and Drug Administration (“FDA”) regarding Processa’s next Phase 2 study supporting the advancement of Next Generation Capecitabine (“NGC-Cap”) for cancer patients. “The FDA provided helpful guidance on the overall design of our NGC-Cap Phase 2 study for which we anticipate beginning enrollment in mid-2024. We believe that NGC-Cap may provide a better safety/efficacy profile than FDA-approved Capecitabine, eventually providing treatment for the tens of thousands of patients who cannot tolerate the existing Capecitabine,” said David Young, PharmD, Ph.D, president of research and development at Processa. “The results to date of our present Phase 1b oncology study clearly show that the metabolism and distribution of NGC-Cap is better than Capecitabine and that the safety/efficacy profile will likely be significantly better once we can identify the optimal dosage regimen.”

Processa Pharmaceuticals (NASDAQPCSA), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs to improve the efficacy and safety for patients suffering from cancer, will be presenting at the MedInvest Oncology Investor Conference. According to the announcement, Dr. David Young, president of research and development for Processa, will be presenting virtually during the conference, which is scheduled for Dec. 5–6, 2023, in Palo Alto, California. Young’s presentation will begin at 1:35 p.m. PST on Dec. 5. In addition to Young’s virtual presentation, the company noted that Processa CEO George Ng will be attending the event in person and will be available for one-on-one meetings with investors.