Imunon(IMNN)

Search documents
Imunon(IMNN) - 2022 Q1 - Quarterly Report
2022-05-16 12:01
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to ____________ Commission file number: 001-15911 CELSION CORPORATION (Exact name of Registrant as specified in its charter) Delaware 52-1256615 ...
Celsion (CLSN) Investor Presentation - Slideshow
2022-04-14 18:42
Corporate Presentation Nasdaq: CLSN April 2022 Safe Harbor Statement This presentation and any statements made during any presentation or meeting contain forward-looking statements related to Celsion Corporation ("Celsion") under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. These statements may be identified by the use of forward-looking w ...
Imunon(IMNN) - 2021 Q4 - Earnings Call Transcript
2022-03-31 17:41
Celsion Corporation (CLSN) Q4 2021 Earnings Conference Call March 31, 2022 11:00 AM ET Company Participants Monique Kosse - Managing Director, LifeSci Advisors Michael Tardugno - Chairman, President and Chief Executive Officer Jeffrey Church - Senior Vice President, Chief Financial Officer and Corporate Secretary Nicholas Borys - Senior Vice President and Chief Medical Officer Khursheed Anwer - Executive Vice President and Chief Science Officer Conference Call Participants Kumaraguru Raja - Brookline Capita ...
Imunon(IMNN) - 2021 Q4 - Annual Report
2022-03-31 13:06
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021. or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______ to _______ Commission file number: 001-15911 CELSION CORPORATION (Exact Name of Registrant as Specified in Its Charter) DELAWARE 52-1256615 (State or othe ...
Imunon(IMNN) - 2021 Q3 - Earnings Call Transcript
2021-11-15 19:41
Celsion Corporation (CLSN) Q3 2021 Earnings Conference Call November 15, 2021 11:00 AM ET Company Participants Kim Golodetz – HLA Michael Tardugno – Chairman, CEO and President Jeffrey Church – Chief Financial Officer Nicholas Borys – Chief Medical Officer Khursheed Anwer – Chief Science Officer Conference Call Participants Kumar Raja – Brookline Capital Markets David Bautz – Zacks Small Cap Research Mike Worth – Celsion Operator Good morning. My name is Bobby, and I will be your operator today. At this ti ...
Imunon(IMNN) - 2021 Q3 - Quarterly Report
2021-11-15 14:03
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to ____________ Commission file number: 001-15911 CELSION CORPORATION (Exact name of Registrant as specified in its charter) (State or other ...
Imunon(IMNN) - 2021 Q2 - Earnings Call Transcript
2021-08-12 19:40
Celsion Corporation (CLSN) Q2 2021 Earnings Conference Call August 12, 2021 11:00 AM ET Company Participants Kim Golodetz - SVP and Principal Michael Tardugno - Chairman, CEO and President Nicholas Borys - Chief Medical Officer Jeffrey Church - Chief Financial Officer Khursheed Anwer - Executive VP & Chief Scientific Officer Conference Call Participants Kumar Raja - Brookline Capital Operator Please standby, and good morning. My name is Nick, and I will be your operator today. At this time, I would like to ...
Imunon(IMNN) - 2021 Q2 - Quarterly Report
2021-08-12 13:02
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 Q1 - Earnings Call Transcript
2021-05-14 17:54
Celsion Corporation (CLSN) Q1 2021 Earnings Conference Call May 14, 2021 10:00 AM ET Company Participants Kim Golodetz - IR Michael Tardugno - Chairman, CEO and President Jeff Church - CFO Khursheed Anwer - Chief Science Officer Nicholas Borys - Chief Medical Officer Conference Call Participants Kumaraguru Raja - Brookline Capital Markets Operator Please stand by. Good morning. My name is Olivia and I will be your operator today. At this time, I'd like to welcome you all to Celsion’s First Quarter 2021 Fina ...
Imunon(IMNN) - 2021 Q1 - Quarterly Report
2021-05-14 13:05
Commission file number: 001-15911 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) [X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2021 OR [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to ____________ CELSION CORPORATION (Exact name of Registrant as specified in its charter) (State or other ...