CLSN - CLSN STOCK NEWS

Celsion Corporation (NASDAQ: CLSN) announced a conference call on August 12, 2021, to discuss its financial results for Q2 2021 and updates on its product development programs, including GEN-1, a DNA-based immunotherapy for advanced ovarian cancer, and PLACCINE, a synthetic vaccine technology in preclinical studies. Participants can join the call at 11:00 a.m. EDT, with a replay available until August 26, 2021. Celsion is advancing innovative treatments in cancer care, focusing on DNA-based therapies and vaccines.

Celsion Corporation (NASDAQ: CLSN) announced positive results from its Phase 1b OVATION 1 Study of GEN-1 in advanced ovarian cancer. The study showed dose-dependent immune stimulation, with a chemotherapy response score (CRS) of 50% in the two highest GEN-1 doses, compared to 28% for chemotherapy alone. Objectives included a 100% objective response rate and an 88% R0 resection rate. This study is part of ongoing research to improve treatment outcomes for patients with advanced ovarian cancer, leading to the active recruitment for the Phase I/II OVATION 2 Study.

Celsion Corporation (NASDAQ: CLSN) announced that the OVATION 2 Study is now 50% enrolled, with 55 patients evaluated at the 100 mg/m² dose of GEN-1 for advanced ovarian cancer. The Data Safety Monitoring Board confirmed the treatment's safety, with no dose-limiting toxicities and an acceptable risk-benefit profile. Notably, 80% of patients receiving GEN-1 achieved complete tumor resection (R0) compared to 56% in the control group. The company aims to complete patient recruitment by year-end and is pursuing FDA designations to facilitate commercialization.

Celsion Corporation (NASDAQ: CLSN) announced the addition of Dan H. Barouch, M.D., Ph.D. and Luke D. Handke, Ph.D. to its Vaccine Advisory Board, enhancing its expertise in vaccine development. Dr. Barouch, affiliated with Harvard and known for his work on adenovirus-based vaccines, and Dr. Handke, previously at Pfizer, will support Celsion's PLACCINE platform aimed at addressing infectious diseases, including COVID-19. The PLACCINE technology shows promise for broad protection against viral mutations, emphasizing enhanced and durable efficacy.

Celsion Corporation (NASDAQ: CLSN) has commenced enrollment for the Phase I PanDox study at Oxford University, testing its proprietary ThermoDox® treatment for pancreatic cancer in conjunction with focused ultrasound. Supported by the National Institute for Health Research, this study will compare the effectiveness of ThermoDox® with focused ultrasound versus traditional doxorubicin therapy. Key endpoints include assessment of tumor response and safety. The study is expected to conclude by December 2022 and follows promising results from previous studies showing significant increases in drug concentration.

Celsion Corporation (NASDAQ: CLSN) has announced the establishment of Celsion GmbH, a subsidiary that will manage the development of ThermoDox®, freeing Celsion to focus on GEN-1 and PLACCINE. Andreas Voss, M.D., a seasoned oncology researcher, will lead the new subsidiary based in Zug, Switzerland. Celsion will provide limited support for ThermoDox®'s clinical studies, which include Phase I trials for metastatic breast and pancreatic cancers. Despite setbacks in previous trials, interest in ThermoDox® persists within the research community.

Celsion Corporation (NASDAQ: CLSN) has entered into a $10 million loan facility with Silicon Valley Bank to bolster its financial position. The company utilized $6 million to fully retire its debt to Horizon Technology Finance Corporation. The remaining $4 million will be available for working capital and product development, including the advancement of its DNA-based immunotherapy, GEN-1, for ovarian cancer treatment. This strategic move provides Celsion with sufficient cash flow to sustain operations through early 2025, enhancing its balance sheet and operational flexibility.

Celsion Corporation (NASDAQ: CLSN) announced the appointment of Christine A. Pellizzari to its Board of Directors, effective June 8, 2021. This addition expands the Board from seven to eight members. Ms. Pellizzari, currently Chief Legal Officer at Insmed, brings over 20 years of experience in the pharmaceutical industry, having held significant roles in legal and regulatory affairs. Her expertise will support Celsion's advancements in cancer treatments such as GEN-1 for ovarian cancer and the PLACCINE vaccine platform.

Celsion Corporation (NASDAQ: CLSN) has announced the appointment of Stacy R. Lindborg, Ph.D. to its Board of Directors, effective June 4, 2021. Dr. Lindborg fills the vacancy left by Dr. Alberto Martinez, who retired on December 31, 2020. With over 25 years in the pharmaceutical industry, she brings a wealth of experience in drug development, particularly in R&D and regulatory processes. Dr. Lindborg previously held significant roles at Brainstorm Cell Therapeutics and Biogen, contributing to successful clinical trials, including the recent FDA approval of aducanumab.