Product Pipeline and Clinical Studies - Celsion's product pipeline includes GEN-1 for ovarian cancer and ThermoDox, currently in Phase III for primary liver cancer[150] - The OPTIMA Study has enrolled 556 patients globally, evaluating ThermoDox in combination with RFA, with a primary endpoint of overall survival[156] - Post-hoc analysis from the HEAT Study indicated a 54% risk improvement in overall survival for patients treated with ThermoDox plus RFA compared to RFA alone[154] - The first interim analysis of the OPTIMA Study showed a hazard ratio of 0.63, indicating a 37% reduction in the risk of death compared to RFA alone[158] - The second interim analysis reached a hazard ratio of 0.70, representing a 30% reduction in the risk of death compared to RFA alone[164] - Median progression-free survival for the OPTIMA Study reached 17 months, which is favorable compared to 16 months in the HEAT Study subgroup[162] - The OPTIMA Study has lost only 4 patients to follow-up, significantly below the expected loss rate of 3% per year[162] - The DMC recommended the continuation of the OPTIMA Study based on safety and data integrity assessments[157] - The NIH published an analysis indicating that increased RFA heating time correlates with improved overall survival in patients treated with ThermoDox[160] - Celsion plans to continue following patients for overall survival, with a milestone of 197 deaths expected in mid-2021[166] - The HEAT Study did not meet the primary endpoint of progression-free survival (PFS) in a Phase III trial with 701 patients, indicating no clinically meaningful improvement[167] - In the OVATION Study, 14 patients treated with GEN-1 plus standard chemotherapy achieved a 100% disease control rate and an 86% objective response rate (ORR) as per RECIST criteria[171] - The median PFS for patients treated per protocol in the OVATION Study was 21 months, compared to an average of 12 months under the current standard of care for Stage III/IV ovarian cancer[173] - The OVATION 2 Study aims to show a 33% improvement in PFS by comparing GEN-1 with neoadjuvant plus adjuvant chemotherapy versus chemotherapy alone[176] - In the OVATION 2 Study, 64% of patients achieved complete tumor resection (R0) after treatment with GEN-1, with 88% in the highest dose cohorts[179] - The objective response rate (ORR) for patients receiving 0, 36, 47 mg/m² of GEN-1 plus NACT was approximately 80%, comparable to higher dose cohorts[181] - The European Medicines Agency recommended GEN-1 for orphan medicinal product designation for ovarian cancer treatment[182] - The independent Data Safety Monitoring Board (DSMB) approved the continuation of the OVATION 2 Study based on safety reviews of the first eight patients[177] Financial Performance and Capital Management - As of September 30, 2020, the company has incurred approximately $309 million in cumulative net losses and has $18.3 million in cash, investment securities, and interest receivable[189] - The company expects operating losses to continue for the foreseeable future due to ongoing product development and marketing efforts[190] - The company sold net operating losses totaling $13 million in 2018 and 2019, receiving net proceeds of $12.2 million[195] - The company has $10 million in capital from the Horizon Credit Agreement, with $5 million repaid and the remaining obligations restructured[196] - The company raised approximately $30.7 million in gross proceeds from issuing 17.8 million shares of common stock during 2019 and 2020[203] - The company received net proceeds of approximately $9.1 million from an underwritten offering of approximately 2.7 million shares at a price of $3.4875 per share[204] - The company has up to $24.5 million of remaining availability under the LPC Purchase Agreement with Lincoln Park Capital Fund, LLC[197] - The company returned the proceeds of a $632,220 PPP Loan in full on May 13, 2020, and later received a new PPP Loan for $692,530[200][201] - The company continues to monitor the impact of COVID-19 on its operations, with potential material impacts on future financial condition and results[192] - For the three months ended September 30, 2020, the company's net loss was $8.1 million, compared to a net loss of $5.5 million for the same period in 2019, representing a 47.3% increase in net loss[214] - For the nine months ended September 30, 2020, the company's net loss was $18.5 million, compared to a net loss of $13.7 million for the same period in 2019, indicating a 35.1% increase in net loss[214] - As of September 30, 2020, the company had $18.3 million in cash, investments, interest receivable, and income tax receivable, which is expected to fund operations through the end of 2021[215] - The company sold and issued an aggregate of 2.6 million shares under the LPC Purchase Agreement, receiving approximately $1.8 million in gross proceeds during 2020[206] - Under the 2018 Aspire Purchase Agreement, the company sold a total of 3.4 million shares, receiving $6.5 million before the agreement was terminated[205] - The 2019 Aspire Purchase Agreement allowed the company to sell up to $10.0 million of shares, with $0.7 million received from the sale of 0.5 million shares in 2019[205] - The company entered into a Capital on Demand Sales Agreement with JonesTrading, allowing for the sale of up to $16.0 million in shares, with $1.0 million and $4.5 million received in 2019 and 2020 respectively[205] - The LPC Purchase Agreement allows the company to sell up to $26.0 million of shares at its discretion, with a maximum purchase limit of 400,000 shares per business day[206] - The company issued 437,828 shares to Lincoln Park as LPC Commitment Shares, with an initial purchase of 1,000,000 shares for $1.00 per share[206] - The company plans to seek additional capital through public or private equity offerings, debt financing, and strategic alliances, which may dilute existing stockholder ownership[238] - If adequate funds are not available, the company may need to delay or reduce the scope of its research and development programs[239] - The company maintains a diversified investment portfolio to preserve capital and maximize income, with cash flow subject to interest rate fluctuations[241] Operating Expenses and Financial Metrics - Total operating expenses decreased by 22.3% to $4.3 million in Q3 2020 from $5.5 million in Q3 2019[216] - Loss from operations improved by 22.8%, amounting to $(4.2) million in Q3 2020 compared to $(5.4) million in Q3 2019[216] - Research and development expenses decreased by 32.2% to $2.5 million in Q3 2020 from $3.7 million in Q3 2019[218] - General and administrative expenses were stable at $1.8 million for both Q3 2020 and Q3 2019[219] - The company recognized a non-cash impairment charge of $2.4 million for the GBM asset in Q3 2020[220] - For the nine months ended September 30, 2020, total operating expenses decreased by 13.1% to $14.1 million from $16.2 million in the same period of 2019[226] - R&D expenses for the first nine months of 2020 decreased by 14.7% to $8.5 million compared to $10.0 million in the same period of 2019[227] - The company had an accumulated deficit of $309 million as of September 30, 2020[235] - The fair value of the earn-out milestone liability was assessed at $7.1 million as of September 30, 2020, with a non-cash charge of $1.1 million recognized in Q3 2020[223] - As of September 30, 2020, total current assets were $19.9 million, with cash and cash equivalents of $18.3 million, resulting in net working capital of $14.5 million[236] - Net cash used in operating activities for the first nine months of 2020 was $11.9 million, while net cash provided by investing activities was $7.9 million and financing activities provided $15.4 million[237] - The company received $1.3 million from two PPP Loans in 2020, which have been fully repaid as of September 30, 2020[237]
Imunon(IMNN) - 2020 Q3 - Quarterly Report