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Imunon(IMNN) - 2019 Q4 - Earnings Call Transcript
2020-03-26 20:06
Financial Data and Key Metrics Changes - Celsion reported a net loss of $15.9 million or $0.77 per share for the year ended December 31, 2019, compared to a net loss of $11.9 million or $0.68 per share for 2018, indicating an increase in loss [53][60] - Operating expenses were $21.1 million for 2019, a 2% decrease from $21.6 million in 2018 [53] - Cash, investments, and deferred tax assets totaled $16.7 million as of December 31, 2019, with an additional $6 million raised in early 2020 [49][50] Business Line Data and Key Metrics Changes - Research and development expenses increased by 10% to $13.1 million in 2019, while clinical development costs for the OPTIMA study decreased by 25% to $4.1 million due to the completion of enrollment in August 2018 [53][54] - Costs associated with the OVATION 2 study were $600,000 in 2019, compared to $400,000 in 2018 [56] Market Data and Key Metrics Changes - The company anticipates receiving a $1.8 million deferred tax benefit from the sale of New Jersey net operating losses in Q2 2020, extending the operating runway into mid-2021 [50] - Celsion has fewer than 30 million shares outstanding, minimizing dilution over the past few years [25] Company Strategy and Development Direction - Celsion is focused on advancing its gene-mediated immunotherapy GEN-1 and ThermoDox for cancer treatment, with plans to accelerate clinical development strategies [11][22] - The company aims to establish a subsidiary in China to commercialize innovative cancer therapies, leveraging financial incentives from the Chinese government [42][44] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's fundamentals and ongoing clinical trials, despite the challenges posed by the COVID-19 pandemic [21][36] - The company expects no material impact from the pandemic on its ongoing studies, with plans to initiate the OVATION 2 study in the second half of 2020 [20][38] Other Important Information - Celsion's manufacturing strategy includes redundancy measures to ensure supply chain stability during the pandemic [39][41] - The company has begun writing the NDA/MAA for ThermoDox in HCC, aiming for completion within six months of unblinding the OPTIMA Study [45] Q&A Session Summary Question: How is the response rate for GEN-1 compared to historical chemotherapy? - Management acknowledged the small patient numbers and indicated that the immunotherapy's response rate may not directly correlate with R0 resections, suggesting a need for long-term data [71][73] Question: What are the next steps if the second interim analysis for ThermoDox is positive? - Management outlined a detailed plan for NDA submissions and emphasized that COVID-19 should not significantly impact their timeline [80][84] Question: How long is the enrollment expected to take for OVATION 2? - Management estimated that enrollment could take about 12 months, depending on the willingness of clinical trial sites to initiate studies amid the pandemic [90]
Imunon(IMNN) - 2019 Q4 - Annual Report
2020-03-25 20:52
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) [X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2019 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 o ...
Imunon(IMNN) - 2019 Q3 - Earnings Call Transcript
2019-11-15 23:31
Celsion Corporation (CLSN) Q3 2019 Earnings Conference Call November 15, 2019 11:00 AM ET Company Participants Kim Golodetz - LHA Investor Relations Michael Tardugno - Chief Executive Officer Jeffrey Church - Chief Financial Officer Nicholas Borys - Chief Medical Officer Conference Call Participants Jason Kolbert - Dawson James Matthew Cross - Jones Trading Kumaraguru Raja - Brookline Capital Markets Yichuan Yan - Oppenheimer & Company Operator Good morning. My name is Emma and I will be your operator today ...
Imunon(IMNN) - 2019 Q3 - Quarterly Report
2019-11-14 21:23
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 September 30, 2019 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 ot ...
Imunon(IMNN) - 2019 Q2 - Earnings Call Transcript
2019-08-15 22:05
Celsion Corporation (CLSN) Q2 2019 Earnings Conference Call August 15, 2019 11:00 AM ET Company Participants Kim Golodetz - LHA Michael Tardugno - Chairman, President & CEO Jeffrey Church - CFO Conference Call Participants Hartaj Singh - Oppenheimer & Company Jason Kolbert - Dawson James Kumar Raja - Brookline Capital Markets Operator Good morning. My name is Travis and I will be your operator today. At this time, I would like to welcome you all to Celsion Second Quarter 2019 Financial Results Conference Ca ...
Imunon(IMNN) - 2019 Q2 - Quarterly Report
2019-08-14 21:00
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 June 30, 2019 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 j ...
Imunon(IMNN) - 2019 Q1 - Earnings Call Transcript
2019-05-15 20:54
Celsion Corporation (CLSN) Q1 2019 Earnings Conference Call May 15, 2019 11:00 AM ET Company Participants Jeffrey Church - Chief Financial Officer Michael Tardugno - Chairman, President & Chief Executive Officer Khursheed Anwer - Chief Scientific Officer Conference Call Participants Justin Kim - Oppenheimer & Co. Kumar Raja - Brookline Capital Markets Matthew Cross - JonesTrading Barry Rubin - Arsenal Investments Operator Good morning. My name is Cathy and I'll be your operator today. At this time I would l ...
Imunon(IMNN) - 2019 Q1 - Quarterly Report
2019-05-15 12:51
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, 2019 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) - 2018 Q4 - Earnings Call Transcript
2019-03-29 18:51
Celsion Corporation (CLSN) Q4 2018 Earnings Conference Call March 29, 2019 11:00 AM ET Company Participants Jeffrey Church - CFO Michael Tardugno - CEO Nicholas Borys - CMO Conference Call Participants Kumar Raja - Brookline Capital Markets Justin Kim - Oppenheimer Matthew Cross - JonesTrading Operator Good morning. My name is Savanna, and I will be your operator today. At this time, I would like to welcome you all to Celsion's fourth quarter and full year 2018 financial results conference call. All lines h ...
Imunon(IMNN) - 2018 Q4 - Annual Report
2019-03-29 12:53
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K (Mark One) [X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2018 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 Other Jurisdiction ...