Pancreatic Cancer

- Findings underscore that the combination of onvansertib with FOLFIRI and bevacizumab demonstrates clinical activity and is well tolerated in second-line KRAS-mutant mCRC - - Post hoc analysis resulted in a 7.7-fold higher clinical benefit in bev-naïve patients with an ORR of 77% compared to 10% in bev-exposed patients - - Results from this trial, along with translational studies, supported the transition of clinical development of onvansertib to first-line RAS-mutant mCRC - - Initial readout from first-line RAS-mutant mCRC CRDF-004 trial expected in H2 2024 - SAN DIEGO, Oct. 30, 2024 (GLOBE NEWSWIRE) -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced the publication of data from our Phase 2 trial evaluating onvansertib in combination with FOLFIRI and bevacizumab (bev) for the second-line treatment of KRAS mutant metastatic colorectal cancer (mCRC) in the peer-reviewed Journal of Clinical Oncology, the flagship publication of the American Society of Clinical Oncology (ASCO). “It is exciting to see novel therapies in development that are well tolerated and demonstrate clinical activity in KRAS mutant mCRC, a cancer indication that has lacked new treatment options for decades,” said Heinz-Josef Lenz, MD, Professor of Medicine, J. Terrence Lanni Chair in Cancer Research, Deputy Cancer Center Director USC Norris Comprehensive Cancer Center, USC Keck School of Medicine and the national principal investigator on this trial. “The 77% objective response rate observed with onvansertib in combination with standard of care in bev-naïve patients is remarkable, and we look forward to determining the impact that onvansertib can make in the first-line setting.” “We are proud to be recognized by this prestigious oncology journal for our groundbreaking clinical and preclinical findings observed when adding onvansertib to the standard of care for KRAS mutant mCRC,” added Fairooz Kabbinavar, MD, FACP, Chief Medical Officer of Cardiff Oncology. We are highly encouraged by the clinical results demonstrating a 7.7x higher objective response rate (ORR) in patients who were not previously exposed to bev, and our subsequent discovery of a novel mechanism for onvansertib through our translational work. Collectively, these findings and the support of the FDA led us to shift our clinical development program for onvansertib to the first-line setting where all patients are bev-naïve.” The results of the published Phase 2 clinical trial treating patients with KRAS-mutant mCRC (NCT03829410) demonstrated that onvansertib combined with FOLFIRI and bev was well-tolerated and revealed a greater clinical benefit in bev-naïve patients (ORR of 77%, mPFS of 14.9 months) compared to bev-exposed patients (ORR of 10%, mPFS of 6.6 months). In addition, the company showed the underpinnings of this clinical finding using preclinical models which demonstrated onvansertib inhibited the hypoxia pathway and exhibited robust antitumor activity in combination with bev through the inhibition of angiogenesis. Based on these findings, Cardiff Oncology initiated CRDF-004, a Phase 2 randomized clinical trial of onvansertib in combination with SoC (FOLFIRI and bev or FOLFOX and bev) for the first-line treatment of patients with RAS mutant mCRC. The company anticipates releasing initial data from the CRDF-004 trial in the second half of 2024. About Cardiff Oncology, Inc. Cardiff Oncology is a clinical-stage biotechnology company leveraging PLK1 inhibition, a well-validated oncology drug target, to develop novel therapies across a range of cancers. The Company's lead asset is onvansertib, a PLK1 inhibitor being evaluated in combination with standard of care (SoC) therapeutics in clinical programs targeting indications such as RAS-mutated metastatic colorectal cancer (mCRC), as well as in ongoing and planned investigator-initiated trials in metastatic pancreatic ductal adenocarcinoma (mPDAC), small cell lung cancer (SCLC) and triple negative breast cancer (TNBC). These programs and the Company's broader development strategy are designed to target tumor vulnerabilities in order to overcome treatment resistance and deliver superior clinical benefit compared to SoC alone. For more information, please visit https://www.cardiffoncology.com. Forward-Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Cardiff Oncology's expectations, strategy, plans or intentions. These forward-looking statements are based on Cardiff Oncology's current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidate; results of preclinical studies or clinical trials for our product candidate could be unfavorable or delayed; our need for additional financing; risks related to business interruptions, including the outbreak of an epidemic or pandemic such as the COVID-19 coronavirus and cyber-attacks on our information technology infrastructure, which could seriously harm our financial condition and increase our costs and expenses; uncertainties of government or third party payer reimbursement; dependence on key personnel; limited experience in marketing and sales; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. There are no guarantees that our product candidate will be utilized or prove to be commercially successful. Additionally, there are no guarantees that future clinical trials will be completed or successful or that our product candidate will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in Cardiff Oncology's Form 10-K for the year ended December 31, 2023, and other periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Cardiff Oncology does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances. Cardiff Oncology Contact:James LevineChief Financial Officer858-952-7670jlevine@cardiffoncology.com Investor Contact:Kiki Patel, PharmDGilmartin Group332-895-3225Kiki@gilmartinir.com Media Contact:Grace SpencerTaft Communications609-583-1151grace@taftcommunications.com

First patient dosed in Phase 2 clinical trial with NGC-Cap for metastatic breast cancer Positive data from preclinical studies support NGC-Iri’s ability to deliver more SN-38 to tumors compared with either irinotecan or Onivyde® HANOVER, Md., Oct. 30, 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 with improved efficacy and safety, provides updates on its product pipeline, upcoming milestones and business activities, and reports financial results for the three and nine months ended September 30, 2024. “We continued to make progress with our programs as we further demonstrate the potential benefits of our oncology therapeutics,” said George Ng, Chief Executive Officer of Processa Pharmaceuticals. “Our NGC-Cap Phase 2 clinical trial in metastatic breast cancer is underway with the first patient dosed. As this is an open-label trial, we anticipate sharing initial data in the second half of 2025. Additionally, we reported positive findings from preclinical studies that support NGC-Iri’s potential for improved efficacy and a superior side effect profile compared with the commonly used FDA-approved chemotherapy drugs irinotecan and Onivyde®. We are pleased with our progress and remain committed to improving the lives of people with cancer.” Key Program UpdatesProcessa is focused on developing next-generation chemotherapies (NGC) by improving widely used U.S. Food and Drug Administration (FDA)-approved drugs to extend cancer patients’ survival and/or improve their quality of life. This is achieved by altering how drugs are metabolized and/or distributed in the body, including how they reach cancer cells. In addition, Processa utilizes its Regulatory Science Approach, including the principles associated with FDA’s Project Optimus Oncology initiative, in the development of its NGC drug products to achieve a more favorable benefit-risk profile. PCS6422: Next-Generation Capecitabine (NGC-Cap) NGC-Cap is a combination of PCS6422 and capecitabine, which is the oral prodrug of the cancer drug 5-fluorouracil (5-FU). PCS6422 alters the metabolism of 5-FU, resulting in more 5-FU distributed to cancer cells.Earlier this month, the first patient was dosed in a Phase 2 clinical trial (NCT06568692) evaluating NGC-Cap for the treatment of advanced or metastatic breast cancer. The Phase 2 study is a global, multicenter, open-label, adaptive-design trial comparing two different doses of NGC-Cap to FDA-approved monotherapy capecitabine in approximately 60 to 90 patients. The trial is designed to evaluate the safety-efficacy profile of NGC-Cap versus monotherapy capecitabine, to determine the potential optimal dosage regimens of NGC-Cap as required by the FDA Project Optimus Initiative and to evaluate the possibility of personalizing NGC-Cap therapy. The Company expects to announce interim data from this trial in the second half of 2025. PCS3117: Next-Generation Gemcitabine (NGC-Gem) NGC-Gem is an oral analog of gemcitabine (Gemzar®) that is converted to its active metabolite by a different enzyme system, with potential for a positive response in gemcitabine patients including those inherently resistant to or who acquire resistance to gemcitabine.Processa is evaluating the potential of NGC-Gem in patients with pancreatic and other cancers, as well as ways to identify patients who are more likely to respond to NGC-Gem than gemcitabine alone. The Company is requesting a meeting with the FDA to discuss potential trial designs, including implementation of the Project Optimus initiative. PCS11T: Next-Generation Irinotecan (NGC-Iri) NGC-Iri is an analog of SN-38, the active metabolite of irinotecan, that is expected to have an improved safety-efficacy profile in every type of cancer where irinotecan is currently used.As announced in August, two studies in a human melanoma xenograft mouse model measured SN-38 in tumors, plasma and other tissues following administration of NGC-Iri, irinotecan and Onivyde®, the liposomal formulation of irinotecan. One study compared NGC-Iri with irinotecan, and the other compared irinotecan with Onivyde®. The results found that mice administered NGC-Iri had greater accumulation of SN-38 in the tumor compared with other tissues and that less SN-38 accumulated in non-cancer tissues, which could lead to improved efficacy with a more favorable adverse event profile compared with irinotecan and Onivyde®.The Company is currently evaluating the manufacturing process and potential sites for NGC-Iri. In addition, Processa is defining the potential paths to approval, which includes defining the target patient population and the type of cancer, and expects to conduct IND-enabling toxicology studies in 2025. Third Quarter Financial Results Research and development expenses for the third quarter of 2024 were $2.3 million, compared with $1.2 million for the third quarter of 2023. General and administrative expenses for the third quarter of 2024 were $1.1 million, compared with $1.0 million for the third quarter of 2023. The net loss for the third quarter of 2024 was $3.4 million, or $1.03 per share, compared with the net loss for the third quarter of 2023 of $2.1 million, or $1.54 per share. All per-share figures reflect a 1-for-20 reverse stock split that was effective as of January 22, 2024. Cash and cash equivalents were $2.9 million as of September 30, 2024. About Processa Pharmaceuticals, Inc. Processa is a clinical-stage pharmaceutical company focused on developing the Next Generation Chemotherapy (NGC) drugs with improved safety and efficacy. Processa’s NGC drugs are modifications of existing FDA-approved oncology therapies resulting in an alteration of the metabolism and/or distribution of these drugs while maintaining the existing mechanisms of killing the cancer cells. By combining its novel oncology pipeline with proven cancer-killing active molecules and its Regulatory Science Approach, Processa’s strategy is to develop more effective therapy options with improved tolerability for cancer patients through an efficient regulatory path. For more information, visit our website at www.processapharma.com. 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. Company Contact:Patrick Lin(925) 683-3218plin@processapharma.com Investor Relations Contact:Yvonne BriggsAlliance Advisors Investor Relations(310) 691-7100ybriggs@allianceadvisorsir.com [Financial Tables to follow]PROCESSA PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS(in thousands, except share information) (unaudited) September 30, 2024 December 31, 2023 ASSETS Current Assets Cash and cash equivalents $2,891 $4,706 Prepaid expenses and other 1,947 926 Total Current Assets 4,838 5,632 Property and Equipment, net 5 3 Other Assets Lease right-of-use assets, net of accumulated amortization 93 146 Security deposit 6 6 Total Other Assets 99 152 Total Assets $4,942 $5,787 LIABILITIES AND STOCKHOLDERS’ EQUITY Current Liabilities Current maturities of lease liabilities $94 $84 Accounts payable 712 312 Due to licensor - 189 Due to related parties - - Accrued expenses 413 146 Total Current Liabilities 1,219 731 Non-current Liabilities Non-current lease liabilities 2 67 Total Liabilities 1,221 798 Commitments and Contingencies - - Stockholders’ Equity Common stock, par value $0.0001, 100,000,000 shares authorized: 3,271,944 issued and 3,266,944 outstanding at September 30, 2024; and 1,291,000 issued and 1,286,000 outstanding at December 31, 2023 - - Additional paid-in capital 88,511 80,658 Treasury stock at cost — 5,000 shares at September 30, 2024 and December 31, 2023 (300) (300)Accumulated deficit (84,490) (75,369)Total Stockholders’ Equity 3,721 4,989 Total Liabilities and Stockholders’ Equity $4,942 $5,787 PROCESSA PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(in thousands, except per share data)(unaudited) Three Months Ended September 30, Nine Months Ended September 30, 2024 2023 2024 2023 Operating Expenses Research and development $2,288 $1,152 $5,557 $4,479 General and administrative 1,137 1,016 3,760 4,509 Operating Loss (3,425) (2,168) (9,317) (8,988) Other Income (Expense) Interest income, net 40 86 195 271 Net Loss $(3,385) $(2,082) $(9,122) $(8,717) Net Loss per Common Share - Basic and Diluted $(1.03) $(1.54) $(3.13) $(6.81) Weighted Average Common Shares Used to Compute Net Loss Applicable to Common Shares - Basic and Diluted 3,275,998 1,350,188 2,909,941 1,279,298 # # #

SOMERVILLE, Mass., Oct. 30, 2024 /PRNewswire/ -- Aitia, a biotech company pioneering the use of causal AI and Digital Twins in drug discovery and development, is expanding its collaboration with Servier, a global and independent pharmaceutical company, to tackle gliomas, a broad group of brain cancers. This collaboration aims to use Aitia's breakthrough technology which is powered by millions of data points from patient cancer tissues to find new treatments for this deadly disease. Under the terms of the collaboration, Aitia and Servier will work together to discover and, validate novel drug targets and develop novel drug candidates for glioma using Aitia's Gemini Digital Twins and Servier's therapeutic discovery and clinical development expertise in oncology. This collaboration will include exploration of the heterogeneous biology of these brain cancers, mechanisms of resistance, and drug response at the individual patient level. In a recent breakthrough in another form of glioma, specifically Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation following surgery including biopsy, sub-total resection, or gross total resection in adult and pediatric patients 12 years and older, Servier recently announced approval of the brain cancer drug, VORANIGO, the first approved drug for this disease area in almost 25 years. Gliomas, tumors that originate in the brain or spinal cord from glial cells, affects more than 190,000 people worldwide annually. The most aggressive form of glioma, glioblastoma, has an average survival time after diagnosis of approximately 15 months, with less than 7% of patients surviving beyond five years, according to the National Brain Tumor Society. Despite standard treatments like surgery, radiation and chemotherapy, glioblastoma has a high rate of recurrence and there are currently no curative therapies. "We are excited to expand our collaboration with Aitia into gliomas as we continue to prioritize brain cancer after our recent positive results and approval of VORANIGO in the US and in growing number of territories," said Fabien Schmidlin, Global Head of Translational Medicine at Servier. "At Servier, we are committed to advancing therapies for cancer patients with high unmet medical needs, and we believe that integrating Aitia's Gemini Digital Twins with our expertise in oncology, particularly in targeting molecular mutations, could open new avenues for more effective treatments." "Glioma is the among the deadliest forms of cancer, and the lack of broadly effective treatments highlights the urgent need for new approaches that leverage the growth of genetic and multi-omic patient data and breakthroughs in AI," said Colin Hill, CEO and co-founder of Aitia. "We believe that our Gemini Digital Twins, along with Servier's drug discovery and clinical development expertise in hard-to-treat cancers can lead to new breakthrough therapies for this disease." This collaboration represents the fourth area of research Aitia and Servier are collaborating on. The companies began their partnership in 2022, to advance drug discovery, translational, and clinical development efforts in Multiple Myeloma, then expanding in 2023 to include drug discovery and development for pancreatic cancer, and again in January 2024 to discover patient responders for Servier's LRRK2 inhibitor in Parkinson's disease. Aitia's approach centers on two key innovations: causal AI and Gemini Digital Twins. Causal AI goes beyond correlative associations to identify which genetic or molecular changes drive diseases and patient response to therapies. Gemini Digital Twins are virtual models that are reverse-engineered from huge quantities of genetic, multi-omic, and clinical data from patients that reveal how genes, proteins, and other molecules interact within cells and tissues to drive clinical outcomes. These Gemini Digital Twins of a specific disease allow researchers to rapidly test billions of experiments such as gene and protein knockdowns or application of a drug candidate in a human patient context versus animal models or cells in petri dishes. These high-throughput "virtual experiments" in patient-derived Gemini Digital Twins leads to discovering and selecting drug candidates that are more likely to succeed in clinical trials in specific patient populations. About Aitia Aitia is an AI-enabled biotechnology company deploying causal AI and creating Gemini Digital Twins to discover the next generation of breakthrough drugs in neurodegenerative diseases and oncology, including a lead program in Huntington's disease. By leveraging the convergence of multi-omic patient data, high-performance computing, and causal AI, Aitia's Gemini Digital Twins reveal the hidden biological mechanisms of disease to transform the discovery and development of new therapeutics. To date, Gemini Digital Twins have been used to accelerate R&D in oncology, neurodegeneration, cardiometabolic, and immunology. Media Contact: Isabelle Caffry Senior Director, Strategy & Corporate Development [email protected] +1-617-374-2300 Ryan Flinn In Like Flinn Communications [email protected] +1 510-207-7616 SOURCE Aitia WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED