IMUNON Announces Withdrawal of Form S-1 Registration Statement
LAWRENCEVILLE, N.J., May 22, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, today announced that it has filed a request for withdrawal with the Securities and Exchange Commission (SEC) of the Company's Registration Statement on Form S-1 (No. 333-286403), as amended, originally filed on April 4, 2025 (Registration Statement), as the Company no longer intends to pursue a public offering under the Registration Statement at this time. The Registration Statement has not been declared effective by the SEC, and no securities have been sold in connection with the offering described in the Registration Statement.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy the Company's common stock or any securities, and there shall not be any offer, solicitation or sale of securities mentioned in the press release in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities law of such any state or jurisdiction.
About IMUNON
IMUNON is a clinical-stage biotechnology company focused 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, constituting a differentiating approach from conventional therapies. IMUNON is developing its non-viral DNA technology across its modalities. The first modality, TheraPlas®, is developed for the gene-based delivery of cytokines and other therapeutic proteins in the treatment of solid tumors where an immunological approach is deemed promising. The second modality, PlaCCine®, is developed for the gene delivery of viral antigens that can elicit a strong immunological response.
The Company's lead clinical program, IMNN-001, is a DNA-based immunotherapy for the localized treatment of advanced ovarian cancer that has completed multiple clinical trials including one Phase 2 clinical trial (OVATION 2). IMNN-001 works by instructing the body to produce safe and durable levels of powerful cancer-fighting molecules, such as interleukin-12 and interferon gamma, at the tumor site. Additionally, the Company has completed dosing in a first-in-human study of its COVID-19 booster vaccine (IMNN-101). The Company will continue to leverage these modalities and to advance, either directly or through partnership, the technological frontier of plasmid DNA to better serve patients with difficult-to-treat conditions. For more information, please visit www.imunon.com.
Forward-Looking Statements
IMUNON wishes to inform readers that forward-looking statements in this news release are made pursuant to the 'safe harbor' provisions of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including, but not limited to, statements regarding the timing of enrollment of the Company's clinical trials, the potential of any therapies developed by the Company to fulfill unmet medical needs, the market potential for the Company's products, if approved, the potential efficacy and safety profile of our product candidates, and the Company's plans and expectations with respect to its development programs more generally, are forward-looking statements. We generally identify forward-looking statements by using words such as 'may,' 'will,' 'expect,' 'plan,' 'anticipate,' 'estimate,' 'intend' and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances). Readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, uncertainties relating to unforeseen changes in the course of research and development activities and in clinical trials, including the fact that interim results are not necessarily indicative of final results; the uncertainties of and difficulties in analyzing interim clinical data; the significant expense, time and risk of failure in conducting clinical trials; the need for IMUNON to evaluate its future development plans; possible actions by customers, suppliers, competitors or regulatory authorities; and other risks detailed from time to time in IMUNON's filings with the Securities and Exchange Commission. IMUNON assumes no obligation, except to the extent required by law, to update or supplement forward-looking statements that become untrue because of subsequent events, new information or otherwise.
Contacts:
Media
Investors
Jenna Urban
Peter Vozzo
CG Life
ICR Healthcare
212-253-8881
443-213-0505
jurban@cglife.com
peter.vozzo@icrhealthcare.comSign in to access your portfolio
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Business Upturn
16 minutes ago
- Business Upturn
HistoSonics and Cambridge University Unveil Europe's First Edison™ Histotripsy System Powered by Li Ka Shing Foundation Gift
MINNEAPOLIS, United States: HistoSonics, the manufacturer of the Edison® Histotripsy System and novel histotripsy therapy platforms, announced today that Addenbrookes Hospital of Cambridge University Hospital Foundation and Trust will be the first site in the United Kingdom and European continent to offer histotripsy to both NHS and private patients. This was made possible through a generous donation by the Li Ka Shing Foundation (LKSF) as well as the expedited limited market access granted by the MHRA in April 2025. This press release features multimedia. View the full release here: The milestone marks HistoSonics' official entry into the UK and European market. HistoSonics won a coveted place in the Innovative Device Access Pathway pilot in 2024 and through this program, in partnership with the DHSC, MHRA, NIHR, NHSE, and NICE expedited access to patients. HistoSonics will continue to work with UK healthcare stakeholders on our aligned goal of urgently expanding access for all NHS patients. The Li Ka Shing Foundation, established in 1980 by Hong Kong philanthropist Sir Ka-shing Li, has contributed nearly US$4 billion to advancing education, medical research and services, and poverty alleviation across the USA, UK, Canada, and Asia. Recognizing the transformative potential of technological innovation in healthcare, the Foundation's latest gift to the University of Cambridge will build upon its previous donations of five Edison systems with three to Hong Kong, one to Singapore, and one recently to Stanford University. This new gift not only heralds the introduction of the first Edison system in the UK and Europe but also celebrates the enduring partnership between the Li Ka Shing Foundation and Cambridge in their collaborative efforts to fight cancer. By supporting cutting-edge medical technologies that can deliver low cost and highly efficient solutions, the Foundation hopes to enhance patient access with improved healthcare around the world. 'This donation is an historic milestone that brings non-invasive treatment of liver tumors using histotripsy to the UK,' said Mike Blue, President and CEO, HistoSonics. 'We are grateful to the Li Ka Shing Foundation for their visionary support. With Addenbrookes as our first NHS hospital site under UCNA, we are laying the foundation for future expansion into innovation driven hospitals across the UK.' The Edison System, which received FDA De Novo clearance in October 2023, uses non-invasive therapeutic focused ultrasound energy to mechanically destroy and liquefy targeted tissue and tumors without the invasiveness or toxicity of traditional procedures, reducing the risks of bleeding, infection, and damage to surrounding non-targeted tissue. HistoSonics' initial FDA clearance is for the destruction of liver tumors, with ongoing studies focusing on kidney tumors (HOPE4KIDNEY Trial NCT05820087) and pancreas tumors (GANNON Trial NCT06282809). Professor Deborah Prentice, Vice-Chancellor of the University of Cambridge, said: 'We are very fortunate that through the generosity of Sir Ka-shing Li, Addenbrooke's Hospital in Cambridge will be able to use cutting-edge histotripsy technology to improve outcomes for NHS patients. It is technology such as this that allows Cambridge to remain at the forefront of understanding and treating tumors, a position we aim to strengthen further with Cambridge Cancer Research Hospital.' With installations soon to be in five countries including the US, UK, Hong Kong, Singapore and the United Arab Emirates, HistoSonics is actively expanding access to its histotripsy platform and is working closely with clinical leaders, national health systems, and philanthropic partners to accelerate global adoption of histotripsy as a new category of health care. HistoSonics is also pursuing broader UK and European market access via CE marking. United Kingdom Intended Use Statement: The Edison System is intended for the non-invasive mechanical destruction of liver tumours, including the partial or complete destruction of unresectable liver tumours via histotripsy. This includes malignancy linked to primary liver cancer and cases of metastatic disease in the liver. The device should only be used by people who have completed training performed by HistoSonics Inc., and its use guided by the clinical judgement of an appropriately trained physician. Users must read this user guide to understand the warnings, precautions, and clinical trial summary, including reported adverse events. The Edison System has not been evaluated for the treatment of any specific disease, including, but not limited to, cancer or evaluated any specific cancer outcomes (such as local tumour progression, 5-year survival or overall survival). United States Intended Use Statement: The Edison System is intended for the non-invasive mechanical destruction of liver tumors, including the partial or complete destruction of unresectable liver tumors via histotripsy. The FDA has not evaluated the Edison System for the treatment of any disease including, but not limited to, cancer or evaluated any specific cancer outcomes (such as local tumor progression, 5-year survival or overall survival). The System should only be used by physicians who have completed training performed by HistoSonics, and its use guided by the clinical judgment of an appropriately trained physician. Refer to the device Instructions for Use for a complete list of warnings, precautions, and a summary of clinical trial results, including reported adverse events. About HistoSonics HistoSonics is a privately held medical device company developing a non-invasive platform and proprietary sonic beam therapy utilizing the science of histotripsy, a novel mechanism of action that uses focused ultrasound to mechanically destroy and liquify unwanted tissue and tumors. The company is currently focused on commercializing their Edison System in the US and select global markets for liver treatment while expanding histotripsy applications into other organs like kidney, pancreas, prostate, and others. HistoSonics has offices in Ann Arbor, Michigan and Minneapolis, MN. For more information on the Edison Histotripsy System please visit: For patient-related information please visit: View source version on Disclaimer: The above press release comes to you under an arrangement with Business Wire. Business Upturn takes no editorial responsibility for the same.
Business Insider
23 minutes ago
- Business Insider
RBC Capital Sticks to Its Hold Rating for CME Group (CME)
RBC Capital analyst Ashish Sabadra maintained a Hold rating on CME Group (CME – Research Report) on June 8 and set a price target of $269.00. The company's shares closed yesterday at $268.35. Confident Investing Starts Here: Sabadra covers the Industrials sector, focusing on stocks such as APi Group, Cintas, and Equifax. According to TipRanks, Sabadra has an average return of 6.1% and a 62.50% success rate on recommended stocks. In addition to RBC Capital, CME Group also received a Hold from KBW's Kyle Voigt in a report issued on June 4. However, on the same day, Oppenheimer reiterated a Buy rating on CME Group (NASDAQ: CME). CME market cap is currently $98.82B and has a P/E ratio of 27.57. Based on the recent corporate insider activity of 99 insiders, corporate insider sentiment is negative on the stock. This means that over the past quarter there has been an increase of insiders selling their shares of CME in relation to earlier this year. Last month, Daniel Kaye, a Director at CME sold 500.00 shares for a total of $141,205.00.
Business Insider
23 minutes ago
- Business Insider
Nasdaq (NDAQ) Gets a Buy from RBC Capital
RBC Capital analyst Ashish Sabadra maintained a Buy rating on Nasdaq (NDAQ – Research Report) on June 8 and set a price target of $95.00. The company's shares closed yesterday at $85.65. Confident Investing Starts Here: According to TipRanks, Sabadra is a 5-star analyst with an average return of 6.1% and a 62.50% success rate. Sabadra covers the Industrials sector, focusing on stocks such as APi Group, Cintas, and Equifax. Currently, the analyst consensus on Nasdaq is a Moderate Buy with an average price target of $84.58. NDAQ market cap is currently $49.15B and has a P/E ratio of 38.82. Based on the recent corporate insider activity of 83 insiders, corporate insider sentiment is negative on the stock. This means that over the past quarter there has been an increase of insiders selling their shares of NDAQ in relation to earlier this year. Last month, Pc Nelson Griggs, the Pres. Capital Access Platforms of NDAQ sold 8,000.00 shares for a total of $664,240.00.
