Imunon(US:IMNN)2020-03-26 20:06Financial Data and Key Metrics Changes - Celsion reported a net loss of $15.9 million or $0.77 per share for the year ended December 31, 2019, compared to a net loss of $11.9 million or $0.68 per share for 2018, indicating an increase in loss [53][60] - Operating expenses were $21.1 million for 2019, a 2% decrease from $21.6 million in 2018 [53] - Cash, investments, and deferred tax assets totaled $16.7 million as of December 31, 2019, with an additional $6 million raised in early 2020 [49][50] Business Line Data and Key Metrics Changes - Research and development expenses increased by 10% to $13.1 million in 2019, while clinical development costs for the OPTIMA study decreased by 25% to $4.1 million due to the completion of enrollment in August 2018 [53][54] - Costs associated with the OVATION 2 study were $600,000 in 2019, compared to $400,000 in 2018 [56] Market Data and Key Metrics Changes - The company anticipates receiving a $1.8 million deferred tax benefit from the sale of New Jersey net operating losses in Q2 2020, extending the operating runway into mid-2021 [50] - Celsion has fewer than 30 million shares outstanding, minimizing dilution over the past few years [25] Company Strategy and Development Direction - Celsion is focused on advancing its gene-mediated immunotherapy GEN-1 and ThermoDox for cancer treatment, with plans to accelerate clinical development strategies [11][22] - The company aims to establish a subsidiary in China to commercialize innovative cancer therapies, leveraging financial incentives from the Chinese government [42][44] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's fundamentals and ongoing clinical trials, despite the challenges posed by the COVID-19 pandemic [21][36] - The company expects no material impact from the pandemic on its ongoing studies, with plans to initiate the OVATION 2 study in the second half of 2020 [20][38] Other Important Information - Celsion's manufacturing strategy includes redundancy measures to ensure supply chain stability during the pandemic [39][41] - The company has begun writing the NDA/MAA for ThermoDox in HCC, aiming for completion within six months of unblinding the OPTIMA Study [45] Q&A Session Summary Question: How is the response rate for GEN-1 compared to historical chemotherapy? - Management acknowledged the small patient numbers and indicated that the immunotherapy's response rate may not directly correlate with R0 resections, suggesting a need for long-term data [71][73] Question: What are the next steps if the second interim analysis for ThermoDox is positive? - Management outlined a detailed plan for NDA submissions and emphasized that COVID-19 should not significantly impact their timeline [80][84] Question: How long is the enrollment expected to take for OVATION 2? - Management estimated that enrollment could take about 12 months, depending on the willingness of clinical trial sites to initiate studies amid the pandemic [90]