Imunon(US:IMNN)2020-08-14 20:24Financial Data and Key Metrics Changes - As of June 30, 2020, Celsion's cash and short-term investments were $25.5 million, which includes net cash proceeds of $1.8 million from the sale of unused New Jersey net operating losses [37] - The net loss for the second quarter of 2020 was $5.3 million or $0.18 per share, compared to a loss of $5.9 million or $0.29 per share for the same period in 2019, indicating a decrease in losses [40] - Operating expenses decreased by 14% from $5.7 million last year to $4.9 million in the current quarter [40] Business Line Data and Key Metrics Changes - Research and development expenses were $3 million compared to $3.6 million a year ago, with clinical development costs for the Phase III OPTIMA Study down to $600,000 from $1.2 million last year [41] - Costs associated with the OVATION 2 Study increased modestly to about $200,000 in the second quarter, compared to $100,000 in the same period last year [41] - General administrative expenses were $1.9 million in the second quarter of this year, down from $2.1 million for the same period in 2019, primarily due to lower professional fees [42] Market Data and Key Metrics Changes - The company anticipates completing enrollment of approximately 105 patients in the OVATION 2 Study over the next 12 months [9] - The independent Data Monitoring Committee for the Phase 3 OPTIMA Study recommended considering stopping the study due to crossing the futility boundary [24][25] Company Strategy and Development Direction - Celsion is focusing on the development of GEN-1, a gene-mediated immunotherapy for advanced ovarian cancer, and has received Orphan Drug Designation from both the USFDA and the European Medicines Agency [22] - The company is taking steps to eliminate non-essential expenses related to ThermoDox, expecting to save $8 million to $9 million over the next 18 months [23] - Celsion is committed to ensuring sufficient capital to complete enrollment of the OVATION Study and is actively managing cash resources [36] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the potential of GEN-1, highlighting its promising early results and the importance of ongoing studies [22][35] - The company is closely monitoring the impact of the COVID-19 pandemic on its operations and clinical trials, with no major protocol deviations expected for the OVATION 2 Study [66] - Management acknowledged the uncertainty surrounding the OPTIMA Study and emphasized the importance of data maturity in interpreting results [27][60] Other Important Information - The company reported a 22.5% decrease in net cash used for operating activities, from $10.2 million in the prior year to $7.9 million in the current quarter [38] - Celsion has a $75 million shelf registration statement on file with the SEC, with $45 million remaining, providing future funding flexibility [39] Q&A Session Summary Question: Improvements to the manufacturing process for GEN-1 - Management discussed efforts to reduce costs and improve the manufacturing process for GEN-1, including working with multiple suppliers to ensure redundancy and competitive pricing [49][50] Question: Continuation of the OPTIMA trial - Management indicated that they are monitoring patient outcomes closely and may have clarity on the trial's direction by the fourth quarter [54][55] Question: Impact of COVID-19 on the OVATION 2 Study - Management confirmed that they are following ASCO guidelines and do not expect major protocol deviations due to COVID-19 [66] Question: NIH analysis expectations - Management expects the NIH analysis to provide insights into data maturity and the relationship between heating time and survival [70][69] Question: Anomalous data from the OPTIMA trial - Management is evaluating all possibilities regarding the anomalous data from the 26 patients and is investigating the causes of death [75]