Product Development and Clinical Trials - Celsion Corporation's product pipeline includes GEN-1, a DNA-based immunotherapy for ovarian cancer, and ThermoDox, a heat-activated liposomal encapsulation of doxorubicin [131]. - The OVATION I Study reported 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 [141]. - In the OVATION I Study, GEN-1 demonstrated a 100% disease control rate and an 86% objective response rate (ORR) among the fourteen patients treated [142]. - The OVATION 2 Study aims to show a 33% improvement in PFS when comparing GEN-1 with neoadjuvant plus adjuvant chemotherapy versus chemotherapy alone [144]. - The TheraPlas delivery system for GEN-1 has been scaled up to produce 0.6 kg of cGMP lots with reproducible quality [134]. - The TheraPlas technology platform enhances gene transfer activity by approximately 20-fold compared to traditional methods [134]. - The OVATION 2 Study includes up to 110 patients, with 12 to 15 in the Phase I portion and up to 95 in Phase II [144]. - The first fourteen patients in the OVATION I Study experienced no dose-limiting toxicities, indicating a favorable safety profile for GEN-1 [141]. - Celsion's GEN-1 treatment resulted in a 64% complete tumor resection rate (R0) among patients, with 88% in the highest dose cohorts achieving R0 [142]. - The company believes that the immunotherapy approach with GEN-1 could create a more robust and durable antitumor response compared to chemotherapy alone [137]. - GEN-1 treatment resulted in an 82% overall response rate (ORR) for patients receiving higher doses (61, 79, 100 mg/m²) compared to 42% for lower doses (0, 36, 47 mg/m²) in the OVATION I Study [147]. - The Phase Ib OVATION I Study showed a hazard ratio of 0.53 for progression-free survival (PFS), indicating strong efficacy signals for GEN-1 in newly diagnosed advanced ovarian cancer patients [148]. - In the Phase I portion of the OVATION 2 Study, 88% of patients treated with GEN-1 achieved R0 resection compared to 50% in the control arm, reflecting a 38% improvement [150]. - As of February 2021, 34 out of 110 patients had been enrolled in the OVATION 2 Study, with 22 clinical sites initiated across the U.S. and Canada [153]. - The company received Fast Track designation from the FDA for GEN-1, facilitating accelerated clinical development for advanced ovarian cancer treatment [153]. Vaccine Development - The PLACCINE DNA vaccine technology platform aims to address a broad range of infectious agents, including SARS-CoV-2, with a provisional patent application filed in January 2021 [154]. - Celsion's vaccine candidates utilize a multivalent approach to enhance immune response, targeting multiple SARS-CoV-2 antigens alongside IL-12 to stimulate T-cell immunity [160]. ThermoDox and Liver Cancer Treatment - The company’s heat-sensitive liposome technology allows for targeted drug release at specific temperatures, enhancing the efficacy of chemotherapy for liver cancer [166]. - Primary liver cancer (HCC) incidence is approximately 35,000 cases per year in the U.S. and is projected to become the most prevalent form of cancer by 2030 [167]. - Local recurrence rates after radiofrequency ablation (RFA) for liver tumors greater than 3 cm can exceed 40%, highlighting the need for improved treatment options [168]. - The OPTIMA Study aims to enroll up to 550 patients globally to evaluate ThermoDox in combination with RFA for intermediate stage HCC patients [170]. - The primary endpoint of the OPTIMA Study is overall survival (OS), with secondary endpoints including progression-free survival (PFS) and safety [170]. - Post-hoc analysis from the HEAT Study indicated a 54% risk improvement in OS for patients treated with ThermoDox plus optimized RFA compared to optimized RFA alone, with a hazard ratio of 0.65 [172]. - The median OS for the ThermoDox group is projected to exceed 80 months, compared to less than 60 months for the optimized RFA only group [172]. - The second interim analysis of the OPTIMA Study showed a hazard ratio of 0.70, indicating a 30% reduction in the risk of death compared to RFA alone [177]. Financial Performance and Projections - The Company has incurred approximately $323 million in cumulative net losses as of June 30, 2021, with cash and equivalents of approximately $64.5 million [185]. - The Company expects operating losses to continue as it advances product development and marketing efforts [186]. - The COVID-19 pandemic has not significantly impacted the Company's business or operations in 2020 and 2021, but future impacts remain uncertain [187]. - The Company is developing a business model to support investigator-sponsored studies without interfering with its focus on the GEN-1 program and vaccine development [182]. - For the three months ended June 30, 2021, the company's net loss was $5.4 million, compared to a net loss of $5.3 million for the same period in 2020 [205]. - For the six months ended June 30, 2021, the company's net loss was $11.1 million, compared to a net loss of $10.4 million for the same period in 2020 [205]. - The company raised approximately $6.9 million in gross proceeds from its JonesTrading Capital on Demand financing facility during 2021 [194]. - The company received net proceeds of approximately $1.85 million from the sale of net operating losses in May 2021 [191]. - The company has $64.5 million in cash and cash equivalents as of June 30, 2021, which is expected to fund operations through the end of 2024 [194]. - The New Jersey State Legislature increased the maximum lifetime benefit per company from $15 million to $20 million, allowing the company to participate in the funding program in future years [191]. - The company entered into a $10 million loan facility with Silicon Valley Bank in June 2021, using $6 million to retire existing debt [192]. - The company issued a total of 62.5 million shares of common stock for an aggregate of $83.2 million in gross proceeds during 2020 and 2021 [201]. - The company filed a new $100 million shelf registration statement with the SEC on March 19, 2021, allowing for future capital raises [200]. - The company expects to receive up to approximately $1.4 million from the sale of net operating losses during 2021 [197]. - As of June 30, 2021, the company had $64.5 million in cash and cash equivalents, which is expected to fund operations through 2024 [206]. - Licensing revenue remained unchanged at $125,000 for the three months ended June 30, 2021, compared to the same period in 2020 [207]. - Total operating expenses increased by 6.2% to $5.2 million for the three months ended June 30, 2021, compared to $4.9 million in the same period of 2020 [207]. - Research and development expenses decreased by 13.3% to $2.6 million in Q2 2021 from $3.0 million in Q2 2020 [209]. - General and administrative expenses increased by 36.9% to $2.6 million in Q2 2021 compared to $1.9 million in Q2 2020 [210]. - The company reported a loss from operations of $5.1 million for the three months ended June 30, 2021, a 6.4% increase from a loss of $4.8 million in the same period of 2020 [207]. - Net cash used in operating activities for the first half of 2021 was $7.3 million, while net cash provided by financing activities was $54.8 million [225]. - The company had an accumulated deficit of $323 million as of June 30, 2021 [222]. - Total current assets increased to $60.3 million as of June 30, 2021, compared to $18.8 million at December 31, 2020 [224]. - The company incurred $0.4 million in interest expense in the first half of 2021, down from $0.7 million in the same period of 2020 [221]. Capital and Funding Strategies - The company plans to seek additional capital through public or private equity offerings, debt financing, strategic alliances, and licensing arrangements [226]. - If adequate funds are not available, the company may need to delay or reduce the scope of its research, development, and commercialization efforts [227]. - The company maintains a diversified investment portfolio, which is subject to fluctuations due to changes in interest rates [229]. - The securities in the investment portfolio are classified as available-for-sale and recorded at fair value, with unrealized gains or losses affecting stockholders' equity [229]. - The company is exploring government-sponsored research collaborations and grants to offset anticipated operational losses [226]. - There are no off-balance sheet arrangements or contractual obligations reported [228]. - The company may need to relinquish rights to certain technologies or products if it seeks strategic alliances or alternative arrangements [226]. - The overall economic climate could impact the terms of any financing arrangements, potentially making them less favorable [226]. - The company aims to preserve capital while maximizing income from investments without significantly increasing risk [229]. - The potential dilution of stockholder ownership is a concern if additional funds are raised through equity securities [226].
Imunon(IMNN) - 2021 Q2 - Quarterly Report