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<ul><li>On November 25, 2024, Imunon, Inc. (IMNN) announced it had reached alignment with the U.S. Food and Drug Administration (FDA) on its proposed plan for a Phase 3 trial of IMNN-001 for the treatment of advanced ovarian cancer.</li><li>This includes the overall trial design, the target patient population, the treatment schedule, and the primarly endpoint.</li><li>The finalized protocol is on track to be submitted in December 2024 and we anticipate the 500-patient Phase 3 trial initiating in the first quarter of 2025.</li></ul>

On November 25, 2024, Imunon, Inc. (IMNN) announced it had reached alignment with the U.S. Food and Drug Administration (FDA) on its proposed plan for a Phase 3 trial of IMNN-001 for the treatment of advanced ovarian cancer.This includes the overall trial design, the target patient population, the treatment schedule, and the primarly endpoint.The finalized protocol is on track to be submitted in December 2024 and we anticipate the 500-patient Phase 3 trial initiating in the first quarter of 2025.

IMNN: Comes to Alignment with FDA Regarding Phase 3 Protocol for IMNN-001 

<ul><li>On November 7, 2024, Imunon, Inc. (IMNN) announced financial results for the third quarter of 2024 and provided a business update.</li><li>Following release of positive topline results from the OVATION 2 trial of IMNN-001, which showed an overall survival improvement of 11.1 months compared to standard of care treatment, the company will be meeting with the FDA this month as it finalizes designs of the planned Phase 3 registrational study of IMNN-001 in patients with advanced ovarian cancer.</li><li>We continue to anticipate the 500-patient trial initiating in the first quarter of 2025.</li></ul>

On November 7, 2024, Imunon, Inc. (IMNN) announced financial results for the third quarter of 2024 and provided a business update.Following release of positive topline results from the OVATION 2 trial of IMNN-001, which showed an overall survival improvement of 11.1 months compared to standard of care treatment, the company will be meeting with the FDA this month as it finalizes designs of the planned Phase 3 registrational study of IMNN-001 in patients with advanced ovarian cancer.We continue to anticipate the 500-patient trial initiating in the first quarter of 2025.

IMNN: Meeting with FDA in Preparation for Phase 3 Ovarian Cancer Trial 

<ul><li>On July 30, 2024, Imunon, Inc. (IMNN) announced positive topline results for the Phase 2 OVATION 2 Trial of IMNN-001 in patients with advanced ovarian cancer.</li><li>The company reported an 11.1 month increase in median overall survival (OS) compared with standard-of-care alone in the intent-to-treat (ITT) population with a hazard ratio (HR) of 0.74, which indicates a 35% improvement in survival.</li><li>For the 40% of trial participants treated with a PARP inhibitor, the HR dropped to 0.41, with a median OS in the IMNN-001 treatment arm that had not yet been reached at the time of database lock, compared with a median OS of 37.1 months in the standard-of-care arm.</li></ul>

On July 30, 2024, Imunon, Inc. (IMNN) announced positive topline results for the Phase 2 OVATION 2 Trial of IMNN-001 in patients with advanced ovarian cancer.The company reported an 11.1 month increase in median overall survival (OS) compared with standard-of-care alone in the intent-to-treat (ITT) population with a hazard ratio (HR) of 0.74, which indicates a 35% improvement in survival.For the 40% of trial participants treated with a PARP inhibitor, the HR dropped to 0.41, with a median OS in the IMNN-001 treatment arm that had not yet been reached at the time of database lock, compared with a median OS of 37.1 months in the standard-of-care arm.

IMNN: Positive Results for OVATION 2 Trial Supports Advancing IMNN-001 Into Phase 3 Study 

<ul><li>On May 13, 2024, Imunon, Inc. (IMNN) announced financial results for the first quarter of 2024 and provided a business update.</li><li>The company is on track to report topline results from the OVATION 2 trial of IMNN-001, a DNA-based interleukin-12 (IL-12) immunotherapy as a first-line treatment of locally advanced ovarian cancer, in mid-2024.</li><li>In addition, the company announced it has activated the first site for patient recruitment for the Phase 1 study of IMNN-101, a seasonal COVID-19 vaccine candidate.</li></ul>

On May 13, 2024, Imunon, Inc. (IMNN) announced financial results for the first quarter of 2024 and provided a business update.The company is on track to report topline results from the OVATION 2 trial of IMNN-001, a DNA-based interleukin-12 (IL-12) immunotherapy as a first-line treatment of locally advanced ovarian cancer, in mid-2024.In addition, the company announced it has activated the first site for patient recruitment for the Phase 1 study of IMNN-101, a seasonal COVID-19 vaccine candidate.

IMNN: Results from OVATION 2 Study in Mid-2024 

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Water Tower Research is a leading equity research firm that provides research on micro, small and mid cap companies.

Water Tower Research was founded by Wall Street veterans after witnessing a fundamental shift in the investment research industry with the result being a declining knowledge base among investors, a lack of awareness and a shrinking pool of fundamental research being conducted on companies across the small-cap and micro-cap spectrum. The same issues are now increasingly occurring in the mid-cap space. This sea change within the investment community is impacting not only the companies themselves but also current shareholders and potential investors. With significantly less active sell-side sponsorship by Wall Street, a substantial information gap has developed between companies and various constituents in the financial community. The net result is fewer channels for insight and information to flow between companies and investors.

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<ul><li>We review last week’s biopharma news for meaningful clinical data, regulatory updates, research innovation, and M&amp;A.</li><li>Last week, ADAP received the first TCR-T cell therapy approval in solid tumors. SNDX hit a minor regulatory speed bump, while VTVT got a clinical hold.</li><li>VTYX will move past Tyk2 after its Crohn’s failure. LLY succeeded in its heart failure trial with an obesity drug. </li></ul>

We review last week’s biopharma news for meaningful clinical data, regulatory updates, research innovation, and M&amp;A.Last week, ADAP received the first TCR-T cell therapy approval in solid tumors. SNDX hit a minor regulatory speed bump, while VTVT got a clinical hold.VTYX will move past Tyk2 after its Crohn’s failure. LLY succeeded in its heart failure trial with an obesity drug. 

United States

IMUNON, Inc. operates as a clinical stage biotechnology company. The Company focuses on advancing a portfolio of innovative treatments that harness the body's natural mechanisms to generate safe, effective, and durable responses across a broad array of human diseases. IMUNON serves customers worldwide.

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Imunon (IMNN US)

IMNN: Comes to Alignment with FDA Regarding Phase 3 Protocol for IMNN-001

On November 25, 2024, Imunon, Inc. (IMNN) announced it had reached alignment with the U.S. Food and Drug Administration (FDA) on its proposed plan...

Zacks Small Cap Research

IMNN: Meeting with FDA in Preparation for Phase 3 Ovarian Cancer Trial

On November 7, 2024, Imunon, Inc. (IMNN) announced financial results for the third quarter of 2024 and provided a business update. Following...

Zacks Small Cap Research

IMNN: Positive Results for OVATION 2 Trial Supports Advancing IMNN-001 Into Phase 3 Study

On July 30, 2024, Imunon, Inc. (IMNN) announced positive topline results for the Phase 2 OVATION 2 Trial of IMNN-001 in patients with advanced...

Zacks Small Cap Research

IMNN: Results from OVATION 2 Study in Mid-2024

On May 13, 2024, Imunon, Inc. (IMNN) announced financial results for the first quarter of 2024 and provided a business update. The company is on...

Zacks Small Cap Research

Biopharma Week in Review

We review last week’s biopharma news for meaningful clinical data, regulatory updates, research innovation, and M&A.

Water Tower Research

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