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Celsion Corporation (NASDAQ: CLSN) has announced a registered direct offering of 11,538,462 shares of common stock at $1.30 each, totaling $15 million in gross proceeds. The closing is expected around April 5, 2021, pending customary conditions. A.G.P./Alliance Global Partners is the sole placement agent, with JonesTrading and Brookline Capital as co-placement agents. The offering is conducted under an effective shelf registration statement, and a prospectus supplement will be filed with the SEC.
Celsion Corporation (NASDAQ: CLSN) reported a 2020 net loss of $21.5 million ($0.67 per share), slightly worse than a $16.8 million loss in 2019. R&D expenses decreased by 15% to $11.3 million. The Phase I/II OVATION 2 Study with GEN-1 for ovarian cancer is over a third enrolled, showing promising interim results: 81% of GEN-1 patients achieved R0 resection, a 41% improvement over the control group. The company received FDA Fast Track designation for GEN-1 and filed a provisional patent for a DNA vaccine platform. Celsion has a strong balance sheet with a cash runway extending through 2023.
Celsion Corporation (NASDAQ: CLSN) announced a conference call on March 19, 2021, at 11:00 a.m. EDT to discuss the financial results for 2020 and updates on their clinical developments, including GEN-1 for ovarian cancer and ThermoDox® for other cancer indications. Celsion focuses on DNA-based immunotherapy and next-generation vaccines, with GEN-1 currently in Phase II trials. The call will be accessible via phone and online, with a replay available for 90 days post-call.
Celsion Corporation (NASDAQ: CLSN) has announced the acceptance of a poster for its Phase I/II OVATION 2 Study featuring GEN-1 in advanced ovarian cancer at the Virtual Annual Meeting on Women’s Cancer, occurring from March 19-25, 2021. This study aims to evaluate GEN-1's effectiveness in combination with neoadjuvant chemotherapy. Preliminary results show that GEN-1 treatment led to an 81% R0 resection rate, compared to 58% in the control group, indicating a 40% improvement. GEN-1 has received Fast Track designation from the FDA to expedite its development.
Celsion Corporation (NASDAQ: CLSN) will engage in one-on-one meetings with investors during the Virtual 33rd Annual Roth Conference from March 15-17, 2021. A pre-recorded webcast of their presentation will be available on their website prior to the event. Interested investors are encouraged to contact their Roth Capital Partners sales representative for meeting arrangements. Celsion specializes in innovative cancer treatments, focusing on DNA-based immunotherapy and next-generation vaccines, with key products including GEN-1 for ovarian cancer and ThermoDox® for various cancer indications.
Celsion Corporation (NASDAQ: CLSN) recently reported interim results from its OVATION 2 Study involving GEN-1, a DNA-mediated interleukin-12 immunotherapy for advanced ovarian cancer. Of the 27 patients who completed surgery, 80% in the GEN-1 group achieved an R0 resection, compared to 58% in the control group, marking a 38% improvement. The study aims to enroll 110 participants, with 34 patients enrolled to date. Additionally, GEN-1 has received Fast Track designation from the FDA, indicating its potential as a significant treatment option.
Celsion Corporation (NASDAQ: CLSN) announced it has received approval from the NJEDA to sell $2 million of its unused New Jersey net operating losses (NOLs). This sale is expected to yield approximately $1.85 million in cash proceeds. With this funding, Celsion anticipates over $54 million in cash and investments by the end of Q1 2021, extending its operating runway to early 2024. The company plans to utilize these funds to advance its vaccine initiative and support the Phase I/II OVATION 2 Study for GEN-1.
Celsion Corporation (NASDAQ: CLSN) announced it received Fast Track designation from the FDA for GEN-1, a DNA-mediated immunotherapy for advanced ovarian cancer. The designation aims to expedite development and regulatory review for drugs addressing serious medical needs. GEN-1 showed promising results in Phase I and is currently evaluated in the OVATION 2 Study, combining it with neoadjuvant chemotherapy. Key data indicates a significantly higher complete tumor resection rate in the GEN-1 arm (88%) compared to standard treatment (50%).
Celsion Corporation (NASDAQ: CLSN) has established a Vaccine Advisory Board to advance its PLACCINE DNA vaccine platform aimed at combating infectious diseases, including COVID-19. The board's initial members are leading scientists Dr. Britt A. Glaunsinger and Dr. Xinzhen Yang, both of whom bring substantial expertise in virology and vaccinology. The PLACCINE platform utilizes proprietary plasmid DNA technology to develop vaccines with enhanced efficacy and durability against viral mutations. Celsion continues to focus on innovative treatments in oncology.
Celsion Corporation (NASDAQ: CLSN) announced updates on its vaccine initiative and ongoing studies. The letter from CEO Michael H. Tardugno highlights the PLACCINE DNA vaccine platform aimed at combating infectious diseases, including SARS-CoV-2. Progress in the GEN-1 immunotherapy for ovarian cancer is noted, with one-third of patients enrolled in the OVATION 2 Study. However, the OPTIMA Study for primary liver cancer was halted due to interim findings indicating futility. The company maintains a strong financial position with approximately $58 million in cash, securing a three-year operating runway.
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