Imunon Inc

Imunon, Inc. (NASDAQ: IMNN) is a clinical-stage biotechnology company. The Company is focused on advancing a portfolio of treatments that harness the body’s natural mechanisms across an array of human diseases. The Company is developing non-viral Deoxyribonucleic acid (DNA) technology across four modalities. The first modality, TheraPlas, is developed for the coding of proteins and cytokines in the treatment of solid tumors. The second modality, PlaCCine, is developed for the coding of viral antigens that can elicit a strong immunological response. The third modality, FixPlas, concerns the application of Imunon’s DNA technology to produce universal cancer vaccines, also called tumor associated antigen cancer vaccines. The fourth modality, IndiPlas, is in the discovery phase and is focused on the development of personalized cancer vaccines, or neoepitope cancer vaccines. Its lead clinical program, IMNN-001, is a DNA-based immunotherapy for the localized treatment of advanced ovarian cancer.

Recent Business and Financial Updates

• IMUNON to Report Topline Results from Phase 2 OVATION 2 Study: IMUNON, Inc. will release topline results from its Phase 2 OVATION 2 Study, evaluating IMNN-001 in patients with advanced ovarian cancer, on July 30, 2024, at approximately 8:00 a.m. Eastern time. This will be followed by an investment community conference call at 8:30 a.m. Eastern time to discuss the results and address questions. IMNN-001 is an interleukin-12 (IL-12) immunotherapy utilizing IMUNON's TheraPlas™ technology.
• IMUNON Announces Database Lock for Phase 2 OVATION 2 Study: On June 24, 2024, IMUNON, Inc. (NASDAQ: IMNN) announced the database lock for its Phase 2 OVATION 2 Study, which evaluates the safety and efficacy of IMNN-001, a novel IL-12 immunotherapy, in patients with advanced ovarian cancer. The study, which involved intraperitoneal administration of IMNN-001 alongside standard neoadjuvant chemotherapy (NACT), has now reached the required 16-month treatment observation duration. Independent statisticians will analyze the raw data, and IMUNON expects to report topline results, including hazard ratios, by the end of July 2024.
• Study Details and Treatment Protocol: The OVATION 2 Study aimed to assess dosing, safety, efficacy, and biological activity of IMNN-001 in combination with NACT for newly diagnosed advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer. The treatment protocol included three cycles of NACT followed by interval debulking surgery and three additional cycles of adjuvant chemotherapy. Patients were randomized 1:1 to receive either standard NACT or NACT plus IMNN-001, with the latter group receiving up to 17 doses of 100 mg/m2 IMNN-001. The study reached full enrollment of 110 patients in September 2022.
• Primary and Secondary Endpoints: The OVATION 2 Study is intended to inform the design of a Phase 3 trial and was not powered for statistical significance. According to the Statistical Analysis Plan (SAP), the primary efficacy analysis will be based on the Intent to Treat (ITT) population, with the primary efficacy endpoint being Progression Free Survival (PFS). Secondary endpoints include Overall Survival (OS), Objective Response Rate, Chemotherapy Response Score, and Surgical Response.
• Leadership Statements: Stacy Lindborg, Ph.D., President and CEO of IMUNON, highlighted the importance of reaching data lock as a significant milestone in the company's mission to provide innovative treatments for ovarian cancer. She expressed confidence in the data maturity, enabling robust analysis of PFS and OS endpoints. Sebastien Hazard, M.D., Ph.D., Chief Medical Officer of IMUNON, emphasized the significance of OS in evaluating the long-term benefits of immunotherapies and its crucial role in planning the Phase 3 trial. Both executives look forward to sharing the trial results with the patient and medical community, hoping that IMNN-001 will offer improved outcomes for those affected by this deadly disease.

Technical Observation (on the daily chart):

The Relative Strength Index (RSI) over a 14-day period stands at a value of 85.86, upward trending and inside overbought zone, with expectations of a consolidation or a short-term further correction. Additionally, the stock's current positioning is above both 50-Day SMA and 200-Day SMA, which can act as a short to medium term support levels.

Individuals can evaluate the stock based on the support and resistance levels provided in the report in case of keen interest taking into consideration the risk-reward scenario.

Markets are trading in a highly volatile zone currently due to certain macro-economic issues and prevailing geopolitical tensions. Therefore, it is prudent to follow a cautious approach while investing.

Related Risk: This report may be looked at from a high-risk perspective and a recommendation is provided for a short duration. This report is solely based on technical parameters, and the fundamental performance of the stocks has not been considered in the decision-making process. Other factors which could impact the stock prices include market risks, regulatory risks, interest rates risks, currency risks, social and political instability risks etc.

Note 1: Past performance is not a reliable indicator of future performance.

Note 2: The reference date for all price data, currency, technical indicators, support, and resistance level is July 30, 2024. The reference data in this report has been partly sourced from REFINITIV.

Note 3: Investment decisions should be made depending on an individual's appetite for upside potential, risks, holding duration, and any previous holdings. An 'Exit' from the stock can be considered if the Target Price mentioned as per the Valuation and or the technical levels provided has been achieved and is subject to the factors discussed above.

Note 4: Target Price refers to a price level that the stock is expected to reach as per the relative valuation method and or technical analysis taking into consideration both short-term and long-term scenarios.

Note 5: ‘Kalkine reports are prepared based on the stock prices captured either from the New York Stock Exchange (NYSE), NASDAQ Capital Markets (NASDAQ), and or REFINITIV. Typically, all sources (NYSE, NASDAQ, or REFINITIV) may reflect stock prices with a delay which could be a lag of 15-20 minutes. There can be no assurance that future results or events will be consistent with the information provided in the report. The information is subject to change without any prior notice.