Panitumumab

Samir R. Patel, M.D., appointed as Chief Executive Officer Abizer Gaslightwala appointed to Board of Directors BOSTON and LONDON, Dec. 18, 2024 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX) today announced the appointment of Samir R. Patel, M.D., as Chief Executive Officer, effective December 16, 2024. Dr. Patel has served as interim Chief Executive Officer since May 2024. Additionally, the Company announced it has appointed Abizer Gaslightwala to its Board of Directors, effective December 16, 2024. Michael Grissinger, a member of the Board of Directors, provided notice of his resignation on December 16, 2024. “Since beginning my role as interim CEO in May 2024, we have worked diligently to close the merger with Peak Bio, which we accomplished in November, and position Akari for continued growth and value creation. Looking ahead, we are focusing our efforts and resources to streamline operations and execute on our portfolio prioritization – our potentially best-in-class ADC platform. I am pleased to solidify my role with the Akari team and look forward to building momentum and driving shareholder value in the near and long term,” commented Dr. Patel, Chief Executive Officer of Akari. About Samir R. Patel, M.D. Dr. Patel currently serves as founder and principal of PranaBio Investments, LLC, a firm providing consulting, strategic advisory, and investment services for small cap biotechnology companies. He is also a consultant to GE Global Research, GE’s innovation engine that is creating novel products and solutions across several sectors including biomanufacturing and biotechnology. He has more than 20 years of experience in life sciences including founding SPEC Pharma, LLC, a company that develops and manufactures injectables used in human and veterinary applications. Previously, Dr. Patel held multiple roles in Medical Affairs with Centocor, Inc. (now Johnson & Johnson Innovative Medicine, part of Johnson & Johnson). He holds multiple patents, has been an author on several publications and has been an investigator in numerous clinical research studies. He has served on the boards of several public companies, including Rezolute Bio. Dr. Patel received his medical degree from the Medical College of Ohio and completed his internal medicine internship, residency, and rheumatology fellowship at The University of New Mexico School of Medicine Affiliated Hospitals. About Abizer Gaslightwala Mr. Gaslightwala is a well-established biotechnology / pharmaceutical industry leader with a demonstrated track record of success spanning over 25 years in the development and commercialization of novel medicines across a range of companies and therapeutic areas. Mr. Gaslightwala currently serves as the Senior Vice President and Franchise Head for Oncology at Jazz Pharmaceuticals, where he has full responsibility for a portfolio of products spanning both solid and hematological malignancies that have total annual sales of $1B. These brands include ZIIHERA® for HER2+ cancers, ZEPZELCA® for small cell lung cancer, and RYLAZE®, DEFITELIO®, and VYXEOS® for a range of hematological malignancies. “We are pleased to welcome Abizer to our Board of Directors. We believe the depth and breadth of his development and commercialization leadership and expertise amassed over the course of his career will provide valuable insight as we work to propel Akari to its next phase of growth. Additionally, we would like to thank Michael for his years of service on our board. His perspective and guidance have played a key role in getting the Company to where we are today,” added Dr. Patel. Mr. Gaslightwala added, “I'm thrilled to join the Akari board and have been extremely compelled by the Company’s unique ADC platform targeting the spliceosome, that has the potential to set a new standard of care for cancer patients. I look forward to working closely with the management team and other members of the board to advance this platform forward and potentially address areas of significant unmet need for cancer patients.” Prior to his current position at Jazz Pharmaceuticals, Mr. Gaslightwala has led and driven growth in several leadership roles at Amgen, Pfizer, and Johnson & Johnson across multiple brands including Kyprolis®, Vectibix®, Neulasta®, XGEVAf®, Repatha®, and ELIQUIS®. His experience spans business unit leadership, brand marketing, sales leadership, commercial pipeline planning, advanced analytics and insights, and business development. Mr. Gaslightwala also helped lead R&D strategic planning within the autoimmune/inflammation portfolio at Johnson & Johnson, as well as lead commercial planning for Remicade® and several novel pipeline molecules focused on rheumatoid arthritis, inflammatory bowel disease, psoriasis, and atopic dermatitis. Additionally, Mr. Gaslightwala advised several life science companies through his time at the Boston Consulting Group (BCG). Mr. Gaslightwala holds a BS in Chemical Engineering from Cornell University, and an MBA from the Sloan School of Management, and a MS in Chemical Engineering from MIT. About Akari Therapeutics Akari Therapeutics, Plc (Nasdaq: AKTX) is a biotechnology company developing advanced therapies for autoimmune, oncology and inflammatory diseases. Akari has two lead assets, investigational nomacopan and an antibody drug conjugate (ADC) platform. Nomacopan is a bispecific recombinant inhibitor of complement C5 activation and leukotriene B4 (LTB4) activity. The Company’s ADC platform includes novel toxins and linkers coupled with important cancer antibody targets. For more information about Akari, please visit akaritx.com. Cautionary Note Regarding Forward-Looking Statements This press release includes express or implied forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act), about the Company that involve risks and uncertainties relating to future events and the future performance of the Company. Actual events or results may differ materially from these forward-looking statements. Words such as “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “future,” “opportunity” “will likely result,” “target,” variations of such words, and similar expressions or negatives of these words are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. Examples of such forward-looking statements include, but are not limited to, express or implied statements regarding: the business combination and related matters, including, but not limited to, post-closing operations and the outlook for the Company’s business; the Company’s targets, plans, objectives or goals for future operations, including those related to its product candidates; financial projections; future economic performance,; and the assumptions underlying or relating to such statements. These statements are based on the Company’s current plans, estimates and projections. By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific. A number of important factors, including those described in this communication, could cause actual results to differ materially from those contemplated in any forward-looking statements. Factors that may affect future results and may cause these forward-looking statements to be inaccurate include, without limitation: the risk that Akari and Peak Bio may not realize the anticipated benefits of the Merger in the time frame expected, or at all; the ability to retain and hire key personnel; potential adverse reactions or changes to business relationships resulting from the Merger; the potential impact of unforeseen liabilities, future capital expenditures, revenues, costs, expenses, earnings, synergies, economic performance, indebtedness, financial condition and losses on the future prospects, business and management strategies for the management, expansion and growth of the combined business; uncertainties as to the long-term value of Akari’s American Depositary Shares (and the ordinary shares represented thereby), including the dilution caused by Akari’s issuance of additional American Depositary Shares (and the ordinary shares represented thereby) in connection with the Merger; risks related to global as well as local political and economic conditions, including interest rate and currency exchange rate fluctuations; potential delays or failures related to research and/or development of the Company’s programs or product candidates; risks related to any loss of the Company’s patents or other intellectual property rights; any interruptions of the supply chain for raw materials or manufacturing for the Company’s product candidates, the nature, timing, cost and possible success and therapeutic applications of product candidates being developed by the Company and/or its collaborators or licensees; the extent to which the results from the research and development programs conducted by the Company, and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; uncertainty of the utilization, market acceptance, and commercial success of the Company’s product candidates; unexpected breaches or terminations with respect to the Company’s material contracts or arrangements; risks related to competition for the Company’s product candidates; the Company’s ability to successfully develop or commercialize its product candidates; potential exposure to legal proceedings and investigations; risks related to changes in governmental laws and related interpretation thereof, including on reimbursement, intellectual property protection and regulatory controls on testing, approval, manufacturing, development or commercialization of any of the Company’s product candidates; the Company’s ability to maintain listing of its ADSs on the Nasdaq Capital Market. While the foregoing list of factors presented here is considered representative, no list should be considered to be a complete statement of all potential risks and uncertainties. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the SEC, copies of which may be obtained from the SEC's website at www.sec.gov. The Company assumes no, and hereby disclaims any, obligation to update the forward-looking statements contained in this press release. Investor Contact: JTC Team, LLCJenene Thomas908.824.0775AKTX@jtcir.com A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/110aebf9-2683-41c9-ba9d-bf06f7e42054

Phase 1b/2a open-label trial in the U.S. of certepetide in combination with neoadjuvant FOLFIRINOX-based therapies in pancreatic, colon and appendiceal cancersBASKING RIDGE, N.J., Dec. 10, 2024 (GLOBE NEWSWIRE) -- Lisata Therapeutics, Inc. (Nasdaq: LSTA) (“Lisata”), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, today announced the successful completion of patient enrollment in all three cohorts of the Phase 1b/2a CENDIFOX trial. This investigator-initiated trial, led by Dr. Anup Kasi at The University of Kansas (“KU”) Cancer Center, is evaluating the safety and efficacy of Lisata's iRGD cyclic peptide product candidate, certepetide, in combination with FOLFIRINOX-based therapies for pancreatic, colon, and appendiceal cancers. “The successful enrollment of all three cohorts in the CENDIFOX trial is another significant milestone, bringing us closer to validating certepetide’s potential as a transformative treatment for advanced solid tumors,” stated Kristen K. Buck, M.D., Executive Vice President of Research and Development and Chief Medical Officer of Lisata. “By addressing the unmet medical needs of patients with solid tumors, we aim to improve patient outcomes and augment the standard-of-care paradigm. We are excited about the progress of the CENDIFOX trial and eagerly anticipate reporting the results from this important study in 2025.” The open-label CENDIFOX trial is designed to assess the safety and therapeutic effects of combining certepetide with neoadjuvant FOLFIRINOX regimens, with or without panitumumab, across pancreatic, colon, and appendiceal cancers. The study, conducted solely at the KU Cancer Center, enrolled a total of 66 patients (35 resectable and borderline resectable pancreatic cancer patients, 18 high-grade colon and appendiceal cancer patients with peritoneal metastasis, and 13 colon cancer patients with oligo-metastatic disease). The trial will provide Lisata with valuable pre- and post-treatment tumor tissue data for immune profiling, along with long-term patient outcomes information. The trial is funded by the KU Cancer Center and Lisata is supplying certepetide. “We are delighted to complete enrollment in all three cohorts in the CENDIFOX study and are encouraged by certepetide’s potential to improve outcomes for patients with advanced solid tumors,” stated Dr. Anup Kasi, the study’s Principal Investigator at the KU Cancer Center. “We are eager to analyze the data from each cohort to determine the efficacy of this novel therapy.” For more information on the CENDIFOX trial, please visit www.clinicaltrials.gov/study/NCT05121038. About Certepetide Certepetide, an internalizing RGD, or arginylglycylaspartic acid, (iRGD) cyclic peptide product, is an investigational drug designed to selectively activate the C-end rule active transport mechanism in a tissue-specific manner, resulting in systemically co-administered agents more efficiently penetrating and accumulating in the tissue. To date, certepetide has demonstrated favorable safety, tolerability, and clinical activity in completed and ongoing oncology clinical trials designed to demonstrate its ability to enhance the effectiveness of standard-of-care chemotherapy for pancreatic cancer, as well as the combination of chemotherapy and immunotherapy in a variety of solid tumors. Beyond its promising applications in oncology, certepetide's unique mechanism of action has the potential to be explored in various non-oncology settings. Its ability to selectively target specific tissues could offer new therapeutic possibilities for a range of diseases. Certepetide has been awarded Fast Track designation (U.S.) and Orphan Drug Designation for pancreatic cancer (U.S. and E.U.), as well as Orphan Drug Designation for glioma, osteosarcoma, and cholangiocarcinoma (U.S.). Additionally, certepetide has received Rare Pediatric Disease Designation for osteosarcoma (U.S.). About Lisata Therapeutics Lisata Therapeutics is a clinical-stage pharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies for the treatment of advanced solid tumors and other major diseases. Lisata’s internalizing RGD, or arginylglycylaspartic acid, (iRGD) cyclic peptide product candidate, certepetide, is an investigational drug designed to activate a novel uptake pathway that allows co-administered or tethered anti-cancer drugs to selectively target and penetrate solid tumors more effectively. Lisata has already established noteworthy commercial and R&D partnerships based on its CendR Platform® technology. The Company expects to announce numerous milestones over the next 1.5 years and believes that its projected capital will fund operations into early 2026, encompassing anticipated data milestones from its ongoing and planned clinical trials. Learn more about certepetide’s mechanism of action in our short film. For more information on the Company, please visit www.lisata.com. About The University of Kansas Cancer Center The University of Kansas Cancer Center is transforming cancer research and clinical care by linking an innovative approach to drug discovery, delivery and development to a nationally accredited patient care program. Our consortium center includes cancer research and health care professionals associated with the University of Kansas Medical Center and The University of Kansas Health System; the University of Kansas, Lawrence; The Stowers Institute for Medical Research; Children’s Mercy; and in partnership with members of the Masonic Cancer Alliance. Forward-Looking Statements This communication contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this communication regarding the Company’s clinical development programs are forward-looking statements. In addition, when or if used in this communication, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to Lisata or its management, may identify forward-looking statements. Examples of forward-looking statements include, but are not limited to, the potential efficacy of certepetide as a treatment for patients with cholangiocarcinoma and other solid tumors; statements relating to Lisata’s continued listing on the Nasdaq Capital Market; expectations regarding the capitalization, resources and ownership structure of Lisata; the approach Lisata is taking to discover and develop novel therapeutics; the adequacy of Lisata’s capital to support its future operations and its ability to successfully initiate and complete clinical trials; and the difficulty in predicting the time and cost of development of Lisata’s product candidates. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: results observed from a single patient case study are not necessarily indicative of final results and one or more of the clinical outcomes may materially change following more comprehensive reviews of the data and as more patient data becomes available, including the risk that unconfirmed responses may not ultimately result in confirmed responses to treatment after follow-up evaluations; the risk that product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials; the safety and efficacy of Lisata’s product candidates, decisions of regulatory authorities and the timing thereof, the duration and impact of regulatory delays in Lisata’s clinical programs, Lisata’s ability to finance its operations, the likelihood and timing of the receipt of future milestone and licensing fees, the future success of Lisata’s scientific studies, Lisata’s ability to successfully develop and commercialize drug candidates, the timing for starting and completing clinical trials, rapid technological change in Lisata’s markets, the ability of Lisata to protect its intellectual property rights; and legislative, regulatory, political and economic developments. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in Lisata’s Annual Report on Form 10-K filed with the SEC on February 29, 2024, and in other documents filed by Lisata with the Securities and Exchange Commission. Except as required by applicable law, Lisata undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. Lisata Therapeutics Contact: Investors:Lisata TherapeuticsJohn MendittoVice President, Investor Relations and Corporate CommunicationsPhone: 908-842-0084Email: jmenditto@lisata.com Media:ICR HealthcareElizabeth ColemanSenior AssociatePhone: 203-682-4783Email: elizabeth.coleman@icrhealthcare.com University of Kansas Cancer Center Contact: Media:Kay HawesAssociate Director of News and Media Relationskhawes@kumc.edu