Imunon(IMNN)
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Imunon(IMNN) - 2023 Q2 - Quarterly Report
2023-08-10 12:25
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 June 30, 2023 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 Imunon, Inc. (Exact name of Registrant as specified in its charter) Delaware 52-1256615 (State o ...
Imunon(IMNN) - 2023 Q1 - Quarterly Report
2023-05-11 13:00
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, 2023 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 Imunon, Inc. NA (Former name, former address and former fiscal year, if changed since last repo ...
Imunon(IMNN) - 2022 Q4 - Annual Report
2023-03-30 12:21
COMMISSION FILE NO.: 001-15911 For the fiscal year ended December 31, 2022. or UNITED STATES SECURITIES AND EXCHANGE COMMISSION ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Washington, D.C. 20549 FORM 10-K (Mark One) For the transition period from _______ to _______ ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 (State or other jurisdiction of incorporation or organization) | Title of each class | Trading Symbol(s) | Name ...
Imunon(IMNN) - 2022 Q3 - Earnings Call Transcript
2022-11-16 16:33
Imunon, Inc. (NASDAQ:IMNN) Q3 2022 Earnings Conference Call November 14, 2022 11:00 AM ET Company Participants Kim Golodetz - Investor Relations Corinne Le Goff - President and Chief Executive Officer Jeffrey Church - Chief Financial Officer Khursheed Anwer - Chief Science Officer Nicholas Borys - Chief Medical Officer Conference Call Participants Emily Bodnar - H.C. Wainwright & Co, LLC James Molloy - Alliance Global Partners David Bautz - Zacks Small-Cap Research Operator Good morning. My name is Marliese ...
Imunon(IMNN) - 2022 Q3 - Quarterly Report
2022-11-14 13:19
FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 For the quarterly period ended September 30, 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 Imunon, Inc. (Exact name of Registrant as specified in its charter) Delaware 52-1256615 (St ...
Imunon(IMNN) - 2022 Q2 - Earnings Call Transcript
2022-08-15 19:31
Celsion Corporation (CLSN) Q2 2022 Earnings Conference Call August 15, 2022 11:00 AM ET Company Participants Monique Kosse - IR, LifeSci Advisors Michael Tardugno - Executive Chairman Corinne Le Goff - President & CEO Jeffrey Church - CFO Nicholas Borys - CMO Khursheed Anwer - Chief Science Officer Conference Call Participants Emily Bodnar - H.C. Wainwright Kumar Raja - Brookline Capital Markets David Bautz - Zacks Small-Cap Research Operator Good morning, and welcome to Celsion's Second Quarter 2022 Earnin ...
Imunon(IMNN) - 2022 Q2 - Quarterly Report
2022-08-15 12:00
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]
Imunon(IMNN) - 2022 Q1 - Earnings Call Transcript
2022-05-16 19:26
Celsion Corporation (CLSN) Q1 2022 Earnings Conference Call May 16, 2022 11:00 AM ET Company Participants Monique Kosse - Investor Relations Michael Tardugno - Chairman, Chief Executive Officer and President Jeff Church - Chief Financial Officer Nicholas Borys - Chief Medical Officer Khursheed Anwer - Chief Science Officer Conference Call Participants Emily Bodnar - H.C. Wainwright David Bautz - Zacks Small-Cap Research Operator Good day, everyone and welcome to Celsion’s First Quarter 2022 Earnings Call. M ...
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 ...