Imunon(US:IMNN)2021-05-14 17:54Financial Data and Key Metrics Changes - The company reported a net loss of $5.7 million or $0.09 per share for Q1 2021, compared to a net loss of $5.1 million or $0.20 per share for Q1 2020, indicating a slight increase in loss per share [45] - Operating expenses increased to $5.5 million in Q1 2021, up $600,000 or 13% from $4.9 million in Q1 2020 [46] - Cash and cash equivalents at the end of Q1 2021 were $54.6 million, with additional net proceeds of $13.9 million raised in early Q2 2021 [43][44] Business Line Data and Key Metrics Changes - Research and development expenses were $2.6 million in Q1 2021, down 16% from $3.1 million in the same period last year, primarily due to decreased clinical development costs for the Phase III OPTIMA study [46] - Costs associated with GEN-1 and the OVATION II study increased to $1 million in Q1 2021 from $900,000 in the prior year [47] Market Data and Key Metrics Changes - The company raised over $60 million in equity capital during the first four months of 2021, strengthening its balance sheet [10] - The OVATION 2 study is progressing with 40% of the anticipated 110 patients enrolled, although April saw disappointing enrollment numbers [16][70] Company Strategy and Development Direction - Celsion is focused on advancing its GEN-1 product in advanced ovarian cancer and the PlaCCine vaccine platform, which aims to leverage its TheraPlas technology [11][26] - The company is exploring combination therapies with other agents like Avastin and checkpoint inhibitors, showing promising preclinical data [75][78] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's positioning to achieve development objectives and highlighted the importance of the fast track designation from the FDA for GEN-1 [6][18] - The company acknowledged challenges in patient enrollment due to COVID-19 but indicated a rebound in May and plans to optimize recruitment strategies [69][72] Other Important Information - The company has sufficient cash to fund operations through 2024 at current spending levels, with additional unused net operating losses available for future sale [44] - An annual shareholders' meeting is scheduled for June 4, 2021, where shareholders will vote on proposals including increasing the number of authorized shares [50][51] Q&A Session Summary Question: What stage is the PLACCINE platform at and what needs to be done before human dosing? - The company is in early phase development, aiming to establish proof-of-concept before discussing IND requirements with the agency [60][61] Question: What variations in enrollment are being seen at different sites for GEN-1? - The company noted that 80% of patients come from 20% of sites and is exploring additional opportunities within the GOG network to enhance recruitment [68] Question: What preclinical data exists regarding GEN-1's combination with Avastin or immuno-oncology agents? - Preclinical investigations have shown a synergistic response when combining GEN-1 with Avastin, suggesting potential for lower doses of Avastin in treatment [76][78]