PCS-499

A 0.5 mg daily dose of PCS12852 administered over 28 days in gastroparesis patients successfully improved gastroparesis symptoms in a clinically meaningful way as defined by greater than a 0.5 reduction in the ANMS GCSI-DD score compared to baseline. The percentage of patients who met the clinically meaningful change in symptom score was greater in the PCS12852 0.5 mg daily dose group than in the placebo or the PCS12852 0.1 mg daily dose groups. Over 28 days the mean gastroparesis symptoms score continually improved more for the 0.5 mg PCS12852 group than the placebo group suggesting that longer treatment than 28 days may result in greater differences in gastroparesis symptoms for a 0.5 mg daily dose of PCS12852 than for placebo. The results, in addition to the previously announced improvements in gastric emptying in patients that received the daily dose of 0.5 mg of PCS12852, further support initiating a PCS12852 Phase 2B trial in 2023 for the treatment of gastroparesis. HANOVER, MD, Dec. 14, 2022 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals (Heatwurx Acquired Promet) (Nasdaq: PCSA), a diversified clinical-stage company developing products to improve survival and/or the quality of life for patients who have an unmet medical need condition, today announced positive top-line results on the clinical symptoms associated with gastroparesis from a 4-week Phase 2A study of PCS12852, which is being developed for the treatment of patients with gastroparesis. The trial was a placebo-controlled, randomized, dose-response study designed to evaluate the safety, efficacy, and pharmacokinetics of two dosage regimens of PCS12852 vs placebo (clinicaltrials.gov identifier NCT05270460). Processa previously announced an improvement in the primary endpoint of the study, the gastric emptying rate, in patients that received a 0.5 mg daily dose of PCS12852. The results from this Phase 2A study also showed that clinically meaningful improvements in gastroparesis symptoms occurred in more patients (i.e., a greater percentage of patients) receiving the PCS12852 0.5 mg daily dose than the placebo daily dose. The study included 25 patients with moderate to severe gastroparesis that received a daily dose of PCS12852 (0.1 mg or 0.5 mg) or a placebo. Three patients dropped out of the study. Two patients were in the 0.5 mg group (one because of mild-moderate AEs and one did not provide a reason) and one in the 0.1 mg group (the reason was not provided by the patient). Gastroparesis symptoms were assessed using the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary (ANMS GCSI-DD), which is a validated patient-reported outcome instrument that captures the daily core symptoms of gastroparesis. Publications have stated that a reduction from the baseline of greater than 0.5 in the total ANMS GCSI-DD score is clinically significant (Revicki 2012; Parkman 2018). The total GCSI score is the total of 5 symptom subscores which include nausea, vomiting, early satiety, postprandial fullness, and upper abdominal pain. Although the study was not powered to show a statistically significant difference from the placebo, 100% of the patients receiving the 0.5 mg daily dose of PCS12852 and no rescue medication from Day 22-28 had a clinically meaningful reduction in the total ANMS GCSI-DD score (i.e., a reduction of greater than 0.5 from baseline) while only 57% of the placebo group had a clinically meaningful reduction. In addition, the magnitude of the improvement for the total ANNMS GCSI-DD score and for the subscores was greater for the 0.5 mg PCS12852 group than the placebo group. The 0.1 mg PCS12852 daily dose group showed little to no improvement in gastroparesis symptoms. “This Phase 2A gastroparesis study shows a trend toward an increase in the gastric emptying rate and clinically meaningful improvements in gastroparesis symptoms in patients receiving a 0.5 mg daily dose of PCS12852,” said Dr. Sian Bigora, Chief Development Officer at Processa. “The reduction in clinical symptoms and the continued improvement in the total ANMS GCSI-DD score and multiple individual symptom scores were better for the PCS12852 0.5 mg daily dose group than placebo or the 0.1 mg group. These findings suggest that a longer treatment than 28 days may result in greater differences in the gastroparesis symptoms for the 0.5 mg PCS12852 daily dose group when compared to the placebo dose group. These results, consistent with the previous pre-clinical and clinical studies, give us confidence that dosing 0.5 mg of PCS12852 daily for at least 12 weeks should improve the clinical symptom score more than a placebo treatment.” PCS12852 was shown to be generally well-tolerated, with most AEs occurring in the 0.5 mg dose group and consisting of either a mild or moderate grade. There were no clinically significant cardiovascular, unexpected, severe, or serious adverse events reported during the study. With these positive results from the Phase 2A trial, Processa will be designing the Phase 2B trial and submitting it to their IND. Depending on priorities, funding, and licensing/partnering opportunities a Phase 2B trial could be initiated in 2023. About PCS12852 PCS12852 is a novel, more potent, and more selective 5-hydroxytryptamine-4 (5-HT4) receptor agonist than other 5-HT4 agonists approved by FDA. Other 5-HT4 receptor agonists have been successful in treating GI motility disorders but given their affinity for other receptors, more off-target side effects such as cardiovascular side effects have occurred. In contrast, PCS12852 has been shown in non-clinical studies to be more potent and more selective than other 5-HT4 agonists resulting in fewer adverse events at the therapeutic range of treatment in pre-clinical studies and no reported serious adverse events in clinical studies. Other currently approved options for the treatment of gastroparesis have black box warnings and/or are limited due to adverse events. About Gastroparesis Gastroparesis is a disorder characterized by delayed gastric emptying of solid food in the absence of a mechanical obstruction, particularly pyloric stenosis. This delay may result in the cardinal symptoms of early satiety, postprandial fullness, nausea, vomiting, belching, bloating, and pain. Gastroparesis can be idiopathic, associated with diabetes mellitus, can occur after a medical intervention (iatrogenic or post-surgical), may be associated with neurological disorders, or may occur after a bacterial or viral infection. Although there have been advances in understanding the mechanisms and pathophysiology of gastroparesis, there are still significant gaps in knowledge, inconsistencies across studies, and potential differences between different etiological groups (e.g., diabetic versus idiopathic). Gastroparesis is associated with significantly lower survival. In addition to its effect on mortality, gastroparesis symptoms negatively impact the quality of life and day-to-day functioning of patients. With the limitation on currently approved treatments for gastroparesis, there still is a need for new, effective treatments for the millions of patients with this disorder About Processa Pharmaceuticals, Inc. The mission of Processa is to develop products with existing clinical evidence of efficacy for patients with unmet or underserved medical conditions who need treatment options that improve survival and/or quality of life. The Company uses these criteria for selection to further develop its pipeline programs to achieve high-value milestones effectively and efficiently. Active clinical pipeline programs include Next Generation Capecitabine PCS6422 (metastatic colorectal cancer and breast cancer), PCS499 (ulcerative necrobiosis lipoidica) and PCS12852 (GI motility/gastroparesis). For more information, visit our website at . Forward-Looking Statements This release contains forward-looking statements. The statements in this press release that are not purely historical are forward-looking statements which involve risks and uncertainties. Actual future performance outcomes and results may differ materially from those expressed in forward-looking statements. Please refer to the documents filed by Processa Pharmaceuticals with the SEC, specifically the most recent reports on Forms 10-K and 10-Q, which identify important risk factors which could cause actual results to differ from those contained in the forward-looking statements. For More Information: Michael Floyd (301) 651-4256 mfloyd@processapharma.com Patrick Lin (925) 683-3218 plin@processapharma.com

Controlled study at 21 hospitals shows remote patient management reduces adverse events for home peritoneal dialysis patients New ex vivo study demonstrates superior performance of the Theranova dialyzer in effectively balancing higher removal of large middle-molecule toxins and albumin stability during hemodialysis DEERFIELD, Ill.--(BUSINESS WIRE)-- Baxter International, Inc. (NYSE:BAX), a global innovator in kidney care, advanced scientific exchange with 14 new data presentations about the role innovation plays in increasing access to and quality of home dialysis and expanded hemodialysis (HDx) care at Kidney Week 2022, Nov. 3-6, Orlando, Florida. Key data highlighted include: A study indicating a significant reduction in all-cause mortality and fluid balance, and cardiovascular and metabolic related adverse events, in home automated peritoneal dialysis (APD) patients with Sharesource remote patient management (RPM) versus APD patients without RPM, “Adverse Events and Hospitalizations with Remote Patient Monitoring of Patients on Automated Peritoneal Dialysis” [Abstract #FR-PO504]. A simulated dialysis study indicating expanded hemodialysis (HDx) enabled by Theranova demonstrates the best balance when aiming to achieve higher clearance of larger molecular weight middle molecules while minimizing albumin loss, “On the Removal of Middle Molecules and Albumin Loss: An Ex Vivo Evaluation of Commercial Dialyzers” [Abstract #SA-PO405]. “With a growing global deficit between the number of patients with kidney disease and those receiving care, we believe a combination of collaboration, education and innovation is necessary to help increase both access to and quality of care,” said Peter Rutherford, MB BS, PhD., vice president, Medical Affairs, Baxter Renal Care. “Scientific exchange is an important part of the collaboration and education initiatives, which we are very pleased to support at this year’s Kidney Week.” Sharesource Remote Patient Management Baxter’s Sharesource RPM digital health platform allows healthcare professionals to monitor their patients’ home dialysis treatments, and then remotely adjust therapy without the need for patients to make unplanned visits to the clinic. Sharesource is currently serving more than 50,000 patients, across more than 70 countries on Baxter’s APD cyclers. The RPM study [Abstract #FR-PO504] presented at Kidney Week 2022 was a cluster randomized, controlled trial, at 21 hospitals across Mexico, where care units were randomly assigned to treat their APD patients with or without RPM. HDx Enabled by Theranova HDx enabled by Theranova removes a wider range of molecules from the blood than traditional HD filters, like high-flux membranes, by targeting the effective removal of large middle molecules (up to 45,000 Da),1,2,3 while selectively retaining essential proteins and maintaining stable albumin levels.4,5,6 These middle molecules have been linked to the development of inflammation, cardiovascular disease, and other co-morbidities in dialysis patients.7,8 The new Theranova data [Abstract #SA-PO405] comes from a simulated study that evaluated the challenges associated with increased removal of larger middle molecules while avoiding clinically relevant albumin loss during a dialysis session. During the study, four commercial dialyzers with comparable surface areas were carefully evaluated for solute clearance and albumin loss during four-hour simulated hemodialysis treatments under standardized conditions. Theranova had significantly higher small and large middle molecule clearance (up to 2-3 times higher for YKL40) than two of the other dialyzers as well as lower albumin loss. One dialyzer cleared a higher volume of large middle molecules, but demonstrated albumin loss more than double that observed with Theranova. The study shows further assessment of the dialyzer’s performance in clinic studies is necessary to better understand the benefits of these findings. HDx enabled by Theranova is currently available in 54 countries across Europe, Latin America, Asia, Africa and in the United States and Canada. More than nine million dialysis treatments have been performed worldwide using Theranova in more than 850 clinics. The U.S. Food and Drug Administration granted Theranova a De Novo application in 2020, which established it as a new class of dialyzer technology with unique performance standards. The Theranova Dialyzer is indicated for patients with chronic kidney failure who are prescribed intermittent hemodialysis. It provides an expanded solute removal pro increased removal of various middle molecules (up to 45 kDa) that may play a pathologic role in the uremic clinical syndrome. The Theranova Dialyzer is not intended for hemofiltration or hemodiafiltration therapy. The total extracorporeal blood volume for the Theranova Dialyzer and the set should represent less than 10% of the patient's blood volume. Rx Only: For safe and proper use of the devices mentioned herein, refer to the Instructions for Use. About Baxter Every day, millions of patients, caregivers and healthcare providers rely on Baxter’s leading portfolio of diagnostic, critical care, kidney care, nutrition, hospital and surgical products used across patient homes, hospitals, physician offices and other sites of care. For more than 90 years, we’ve been operating at the critical intersection where innovations that save and sustain lives meet the healthcare providers who make it happen. With products, digital health solutions and therapies available in more than 100 countries, Baxter’s employees worldwide are now building upon the company’s rich heritage of medical breakthroughs to advance the next generation of transformative healthcare innovations. To learn more, visit and follow us on Twitter, LinkedIn and Facebook. This release includes forward-looking statements concerning potential benefits associated with Sharesource and Theranova. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: demand for and market acceptance for new and existing products; product development risks; inability to create additional production capacity in a timely manner or the occurrence of other manufacturing or supply difficulties (including as a result of natural disasters, public health crises and epidemics/pandemics, regulatory actions or otherwise); satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; product quality, manufacturing or supply, or patient safety issues; changes in law and regulations; and other risks identified in Baxter's most recent filing on Form 10-K and Form 10-Q and other SEC filings, all of which are available on Baxter's website. Baxter does not undertake to update its forward-looking statements. Baxter, Sharesource and Theranova are registered trademarks of Baxter International Inc. 1 Hutchison CA, Wolley M. The Rationale for Expanded Hemodialysis Therapy. 2 Kirsch AH, Lyko R, Nilsson LG, et al. Performance of hemodialysis with novel medium cut-off dialyzers. 3 Boschetti-de-Ferro MCO membranes. 4 Kirsch AH, et al. Performance of hemodialysis with novel medium cut-off dialyzers. Nephrol Dial Transpl 2017; 32(1):165-72. 5 Krishnasamy R et al. Trial evaluating mid cut-off value membrane clearance of albumin and light chains in hemodialysis patients (REMOVAL-HD): a safety and efficacy study. ASN 2018 Kidney Week Abstract TH-PO353. 6 Bunch A, et al. Long Term Effects of Expanded Hemodialysis (HDx) on Clinical and Laboratory Parameters in a Large Cohort of Dialysis Patients. ASN 2018 Kidney Week Abstract FR-PO766. 7 Ronco C, et al. Blood Purif. 2017;44(2):I-VIII. 8 Hutchison CA, et al. Contrib Nephrol. 2017;191:142-152.