Imunon(IMNN) - 2022 Q2 - Quarterly Report

Product Development and Clinical Trials - Celsion Corporation is focused on advancing innovative treatments including DNA-based immunotherapies and next-generation vaccines, with a product pipeline that includes GEN-1 for ovarian cancer[122] - The OVATION I Study showed a median progression-free survival (PFS) of 21 months for patients treated with GEN-1, compared to an average of 12 months under current standard care for Stage III/IV ovarian cancer[134] - In the OVATION I Study, 100% of patients in the highest dose cohort achieved an objective response rate (ORR), with 64% having a complete tumor resection (R0)[131] - The TheraPlas delivery system for GEN-1 has demonstrated a 20-fold enhancement in transfection activity, indicating significant improvements in gene delivery efficiency[125] - Celsion's GEN-1 immunotherapy combines IL-12 plasmid with standard chemotherapy, potentially leading to better clinical outcomes than chemotherapy alone[128] - The OVATION 2 Study aims to show a 33% improvement in PFS when comparing GEN-1 with chemotherapy versus chemotherapy alone, involving up to 110 patients[136] - The OVATION I Study reported a 100% disease control rate among the fourteen patients treated, with significant decreases in CA-125 protein levels observed[131] - Celsion is exploring strategies to accelerate the clinical development program for GEN-1 based on promising tumor response and PFS data[132] - The OVATION 2 Study showed that 82% of patients receiving 61, 79, 100 mg/m² of GEN-1 plus NACT achieved R0 resections, compared to 42% for those receiving 0, 36, 47 mg/m²[140] - The overall response rate (ORR) for both dose groups of GEN-1 patients was approximately 80%[140] - As of July 31, 2022, over 90% of the patients have been enrolled in the OVATION 2 study, with no patient in the treatment arm receiving all 17 doses of GEN-1 as prescribed[145] - The Data Safety Monitoring Board recommended continuing the OVATION 2 Study, confirming satisfactory safety and acceptable risk/benefit for the 100 mg/m² dose of GEN-1[143] Vaccine Development - The PLACCINE DNA vaccine technology platform aims to address a broad range of infectious agents, including SARS-CoV-2, and has been filed for provisional patent[146] - Preclinical studies demonstrated that the PLACCINE vaccine produced antibodies and cytotoxic T-cell responses specific to the SARS-CoV-2 spike antigen[154] - The multivalent PLACCINE vaccine showed immunogenicity against two different COVID-19 variants, while commercial mRNA vaccines appeared less effective against newer variants[157] Financial Performance and Projections - The company has incurred substantial operating losses since inception, with cumulative net losses of approximately $xxx million as of June 30, 2022, and $48.1 million in cash and cash equivalents[166] - The company expects operating losses to continue as it undertakes product development and marketing activities, with no assurance of achieving profitability[167] - The company has a $100 million shelf registration statement effective as of March 30, 2021, allowing it to issue various forms of equity[177] - A total of 4.4 million shares of common stock were issued during 2021 and 2022, generating gross proceeds of $65.4 million[178] - For the three months ended June 30, 2022, the company reported a net loss of $6.0 million, compared to a net loss of $5.4 million for the same period in 2021[186] - Total operating expenses for the second quarter of 2022 were $6.1 million, an increase of 17.5% from $5.2 million in the same period of 2021[188] - Research and development expenses rose to $3.2 million in the second quarter of 2022, up from $2.6 million in the same period of 2021, reflecting a 24.4% increase[190] - The company had cash and cash equivalents of $48.1 million as of June 30, 2022, which, along with future planned sales of net operating losses, is expected to fund operations into 2025[187] - The company recognized interest expense of $0.1 million in the second quarter of 2022, down from $0.2 million in the same period of 2021[194] - For the six months ended June 30, 2022, the company reported a net loss of $16.5 million, compared to a net loss of $11.1 million for the same period in 2021[196] - The company recorded licensing revenue of $125,000 for both the second quarters of 2022 and 2021, indicating no change[188] - The company redeemed all 50,000 shares of Series A and Series B Preferred Stock for cash at a price equal to 105% of the stated value per share in March 2022[182] - The company incurred $4.55 million as interest expense related to the preferred shares during the first quarter of 2022[183] - The fair value of the earn-out milestone liability was assessed at $5.4 million with no changes recorded during the second quarter of 2022[193] - Licensing revenue for the first half of 2022 was $250,000, unchanged from the same period in 2021[197] - Total operating expenses increased to $12.1 million in the first half of 2022, a rise of 12.8% compared to $10.7 million in the first half of 2021[197] - Research and development expenses rose to $6.3 million in the first half of 2022, up 22.4% from $5.2 million in the same period of 2021[199] - General and administrative expenses were $5.7 million in the first half of 2022, reflecting a 3.8% increase from $5.5 million in the same period of 2021[200] - The company reported a loss from operations of $11.8 million in the first half of 2022, a 13.1% increase from a loss of $10.5 million in the same period of 2021[197] - As of June 30, 2022, the company had total current assets of $44.9 million and current liabilities of $6.9 million, resulting in net working capital of $38.0 million[207] - Net cash used in operating activities for the first six months of 2022 was $13.4 million, while net cash provided by investing activities was $14.2 million[208] - The company had an accumulated deficit of $349 million as of June 30, 2022[206] - The company expects to seek additional capital through public or private equity offerings, debt financing, and strategic alliances[209] - The company believes it has sufficient capital resources to fund its operations into 2025, with $48.1 million in cash and cash equivalents[208] Study Results and Recommendations - The OPTIMA Study enrolled 556 patients globally to evaluate ThermoDox in combination with RFA for intermediate stage HCC patients, with a primary endpoint of overall survival (OS) and secondary endpoints of progression-free survival (PFS) and safety[159] - The first interim analysis of the OPTIMA Study, conducted after 128 patient deaths, showed that the study should continue based on the DMC's recommendation[160] - The second interim analysis reached 158 patient deaths, indicating a hazard ratio of 0.70, representing a 30% reduction in the risk of death compared to RFA alone[161] - The DMC recommended considering stopping the OPTIMA Study due to crossing the futility boundary, but the final decision was left to the company[161] - The OPTIMA Study was ultimately stopped after independent analyses found no significant evidence to justify continuing patient follow-up, with the database frozen at 185 patient deaths[164]