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Celsion Corporation (NASDAQ: CLSN) provided an update on its lead programs, highlighting significant progress in two areas. The Phase II study of GEN-1 in ovarian cancer is 85% enrolled, with full enrollment expected by Q3 2022. Additionally, the FDA approved a Phase II trial for GEN-1 combined with Avastin for advanced ovarian cancer. Celsion's PLACCINE DNA-based vaccine shows promise, aiming to target multiple COVID-19 variants, with proof-of-concept data favorably compared to commercial vaccines. Further results in non-human primates are anticipated soon.
Celsion Corporation (NASDAQ: CLSN), a clinical-stage biotechnology firm, will host a conference call on May 16, 2022, at 11:00 a.m. ET to discuss its Q1 2022 financial results and updates on its product development initiatives. The company's key product GEN-1 is a DNA-based immunotherapy for treating advanced ovarian cancer and is in Phase II trials. Additionally, Celsion is advancing PLACCINE, a non-viral vaccine delivery technology currently in preclinical studies. For details, visit www.celsion.com.
Celsion Corporation (NASDAQ: CLSN) has presented its PLACCINE platform at the World Vaccine Congress, showcasing its potential in targeting multiple COVID-19 variants. The technology demonstrated neutralizing activity against two strains in murine models, suggesting comparable efficacy to existing vaccines with lasting immunity. Ongoing proof-of-concept studies are expected to yield results in the second half of 2022. This first-in-class platform could also extend to other infectious diseases and cancer vaccines, highlighting Celsion's innovative approach in immunotherapy.
Celsion Corporation (NASDAQ: CLSN) reported positive findings from the OVATION I Study, presented at the AACR Annual Meeting. The Phase Ib study demonstrated that the investigational therapy GEN-1 showed prolonged progression-free survival in Stage III/IV ovarian cancer patients. Utilizing a Synthetic Control Arm, the study revealed a Hazard Ratio of 0.53, indicating significant efficacy. This promising data supports reduced patient enrollment for future trials and has contributed to the Fast Track Designation from the FDA.
Celsion Corporation (NASDAQ:CLSN) announced its participation at the World Vaccine Congress scheduled for April 18-21, 2022, in Washington D.C. Dr. Khursheed Anwar, Chief Scientific Officer, will present on the PLACCINE platform technology during the Cancer and Immunotherapy session. The presentation titled 'Novel DNA Approaches for Cancer Immunotherapies and Multivalent Infectious Disease Vaccines' will occur on April 21, 2022, at 12:00 PM ET. A replay will be available on the investor section of the Celsion website.
Celsion Corporation (NASDAQ: CLSN) has successfully concluded its registered direct offering of 1,328,274 shares of common stock at $5.27 per share, generating net proceeds of $6.4 million. The funds will support general corporate purposes, including R&D, capital expenditures, and working capital. This offering complies with the effective shelf registration statement with the SEC. A.G.P./Alliance Global Partners served as the sole placement agent for this transaction.
Celsion Corporation (NASDAQ: CLSN) announced that their Phase Ib OVATION I Study of GEN-1 in advanced ovarian cancer will be presented at the 2022 AACR Annual Meeting from April 8-13 in New Orleans. The study utilized a Synthetic Control Arm to compare treatment effects with a single-arm trial. Dr. Elizabeth Lamont will present findings indicating that GEN-1 in combination with chemotherapy resulted in prolonged progression-free survival compared to historical controls. This approach minimizes patient burden and accelerates the clinical trial timeline.
Celsion Corporation (NASDAQ: CLSN) has entered into agreements for a registered direct offering to institutional investors, selling 1,328,274 shares at $5.27 each, amounting to gross proceeds of $7.0 million. The transaction is set to close around April 8, 2022, pending customary closing conditions. A.G.P./Alliance Global Partners is the sole placement agent for this offering, which is conducted under the Company’s shelf registration statement effective since March 30, 2021.
Celsion Corporation (NASDAQ: CLSN) announced its cash position of $56.9 million as of December 31, 2021, significantly higher than the erroneous $15 million stated earlier. This correction comes during their earnings announcement on March 31, 2022. The company also secured $1.4 million in non-dilutive funding from the sale of net operating losses in New Jersey. CEO Michael H. Tardugno expressed optimism about their programs, including GEN-1 patient enrollment, expected to exceed 80% by Q3 2022, and the advancement of a DNA-based vaccine for SARS-CoV-2.
Celsion Corporation (NASDAQ: CLSN) announced its 2021 financial results, reporting a net loss of $20.8 million ($3.83 per share), a slight improvement from a $21.5 million loss in 2020. The company highlighted progress in its GEN-1 immunotherapy for advanced ovarian cancer, with over 80% patient enrollment in the OVATION 2 study and a 27% improvement in surgical resection rates. Celsion raised $58.4 million in financing and implemented a reverse stock split. The company maintains a strong balance sheet with $56.9 million in cash and equivalents, sufficient to fund operations through 2024.
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