GEN-1

IMNN-001 immunotherapy plus standard-of-care chemotherapy resulted in 35% improvement in overall survival and 25% improvement in progression-free survival versus standard-of-care alone Treatment was generally well tolerated, with no reports of cytokine release syndrome or any other serious immune related adverse events Company plans to initiate Phase 3 pivotal trial of IMNN-001 in Q1 2025 LAWRENCEVILLE, N.J., Nov. 07, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in late-stage development with its DNA-mediated immunotherapy, today announced the presentation of new clinical data from the recently completed Phase 2 OVATION 2 Study of IMNN-001, its investigational interleukin-12 (IL-12) immunotherapy for the treatment of advanced ovarian cancer based on the company’s proprietary TheraPlas® technology. Results will be highlighted in a late-breaking poster session at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting, taking place November 6-10, 2024, in Houston, Texas and virtually. IMNN-001 is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system that enables cell transfection followed by persistent, local production and secretion of the IL-12 protein. IL-12 is one of the most active pluripotent cytokines for the induction of strong anti-cancer immunity acting through the induction of T-lymphocyte and natural killer cell proliferation, inhibiting tumor mediated immune suppression. A total of 112 patients with newly diagnosed advanced ovarian cancer (intent-to-treat population) were enrolled in the Phase 2 OVATION 2 Study with a median follow-up of 24 months. Study participants were randomized 1:1 to evaluate the safety and efficacy of IMNN-001 (100 mg/m2 administered intraperitoneally weekly) plus neoadjuvant and adjuvant chemotherapy (NACT) of paclitaxel and carboplatin compared to standard-of-care NACT alone. The results being presented at the SITC Annual Meeting, as of June 21, 2024, demonstrated: Patients treated with IMNN-001 plus standard-of-care NACT lived 11.1 months (35%) longer than patients treated with NACT alone with a median overall survival (OS) of 40.5 months and 29.4 months, respectively (hazard ratio 0.74).IMNN-001 treatment was associated with better surgical outcomes compared to NACT alone with a surgical response rate of 64.6% and 52.1%, respectively. The chemotherapy response score, another measure of treatment benefit, was 26.1% in the IMNN-001 treatment group versus 13.0% in the control group.IMNN-001 was also associated with an improvement in progression-free survival (PFS) with a median PFS of 14.9 months in the IMNN-001 treatment group compared to 11.9 months in the control group (hazard ratio 0.79).The rate of complete response for best overall response, a measure of tumor shrinkage, was comparable across all study participants (n=1 in both groups, or 1.7% in IMNN-001 treatment group, 1.9% in the control group) when measured early in the study at debulking surgery.In a subgroup analysis of patients who received a PARP inhibitor as maintenance therapy, patients in the IMNN-001 treatment arm had a median PFS of 33.8 months versus 22.1 months in the control arm (hazard ratio 0.80) and median OS was not reached for the treatment arm versus 37.1 months for the control arm.IMNN-001 was generally well tolerated, with the most common adverse events (AEs) primarily gastrointestinal events (abdominal pain, nausea, vomiting). Pain management protocols were found to be effective. There were no reports of cytokine release syndrome or any other serious immune related AEs. “These results from OVATION 2, including overall survival and progression-free survival among women with advanced ovarian cancer treated with IMNN-001 and NACT compared to standard-of-care NACT alone, reflect a meaningful improvement and show consistency across various endpoints and patient subgroups,” said Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON. “This consistency brings great hope and excitement that these results can be replicated in Phase 3, and that IMNN-001 may offer a significant advancement in the treatment landscape for ovarian cancer. We look forward to our end-of-Phase 2 in-person meeting with the FDA to discuss plans for the Phase 3 pivotal trial, which we expect to start in the first quarter of next year.” “IMNN-001 is the first immunotherapy to achieve a clinically effective response in ovarian cancer, including benefits in both progression-free and overall survival, let alone in a first-line treatment setting,” said study investigator and presenter Jennifer Scalici, M.D., Professor, Division of Gynecological Oncology, Emory University School of Medicine. “It is also especially encouraging that IMNN-001 offers benefits when used alongside PARP inhibitors, which have been very important in the treatment of advanced ovarian cancer but still present limitations in terms of OS benefits. There is a significant unmet need in treating women with ovarian cancer, which is the second deadliest gynecologic malignancy, and the promising results from the OVATION 2 Study represent the potential of IMNN-001 to offer a much-needed treatment option.” The details of the SITC poster presentation are as follows: Abstract Title: Phase I/II study of Safety and Efficacy of Intraperitoneal IMNN-001 with Neoadjuvant Chemotherapy of Paclitaxel and Carboplatin in Patients Newly Diagnosed with Advanced Epithelial Ovarian CancerPresenting Author: Jennifer Scalici, M.D., Professor, Division of Gynecological Oncology, Emory University School of MedicineDate: Friday, November 8, 2024Time: 12:15-1:45 p.m. and 5:30 - 7:00 p.m. CSTAbstract Number: 1505 As previously announced, IMUNON plans to hold an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) in person to discuss the design for a Phase 3 pivotal study of IMNN-001 in advanced ovarian cancer, with the trial expected to start in the first quarter of 2025. About the Phase 2 OVATION 2 Study OVATION 2 evaluated the dosing, safety, efficacy and biological activity of intraperitoneal administration of IMNN-001 in combination with neoadjuvant and adjuvant chemotherapy (NACT) of paclitaxel and carboplatin in patients newly diagnosed with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer. Treatment in the neoadjuvant period is designed to shrink the tumors as much as possible for optimal surgical removal after three cycles of chemotherapy. Following NACT, patients undergo interval debulking surgery, followed by three additional cycles of adjuvant chemotherapy to treat any residual tumor. This open-label study enrolled 112 patients who were randomized 1:1 and evaluated for safety and efficacy to compare NACT plus IMNN-001 versus standard-of-care NACT. In accordance with the study protocol, patients randomized to the IMNN-001 treatment arm could receive up to 17 weekly doses of 100 mg/m2 in addition to NACT. As a Phase 2 study, OVATION 2 was not powered for statistical significance. Additional endpoints included objective response rate, chemotherapy response score and surgical response. About IMNN-001 Immunotherapy Designed using IMUNON's proprietary TheraPlas® platform technology, IMNN-001 is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system that enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anticancer immunity acting through the induction of T-lymphocyte and natural killer cell proliferation. IMUNON previously reported positive safety and encouraging Phase 1 results with IMNN-001 administered as monotherapy or as combination therapy in patients with advanced peritoneally metastasized primary or recurrent ovarian cancer, and completed a Phase 1b dose-escalation trial (the OVATION 1 Study) of IMNN-001 in combination with carboplatin and paclitaxel in patients with newly diagnosed ovarian cancer. About Epithelial Ovarian Cancer Epithelial ovarian cancer is the sixth deadliest malignancy among women in the U.S. There are approximately 20,000 new cases of ovarian cancer every year and approximately 70% are diagnosed in advanced Stage III/IV. Epithelial ovarian cancer is characterized by dissemination of tumors in the peritoneal cavity with a high risk of recurrence (75%, Stage III/IV) after surgery and chemotherapy. Since the five-year survival rates of patients with Stage III/IV disease at diagnosis are poor (41% and 20%, respectively), there remains a need for a therapy that not only reduces the recurrence rate, but also improves overall survival. The peritoneal cavity of advanced ovarian cancer patients contains the primary tumor environment and is an attractive target for a regional approach to immune modulation. 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 Phase 2 development. 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 entered a first-in-human study of its COVID-19 booster vaccine (IMNN-101). IMUNON will continue to leverage these modalities and to advance 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 for commencement of a Phase 3 trial of IMNN-001, the timing and outcome of the Company’s End-of-Phase 2 meeting with the FDA, the timing and 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 of 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: MediaInvestorsCG LifeICR HealthcareJenna UrbanPeter Vozzo212-253-8881443-213-0505jurban@cglife.competer.vozzo@westwicke.com

Conference call today at 11:00 a.m. ET LAWRENCEVILLE, N.J., Nov. 07, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in late-stage development with its DNA-mediated immunotherapy, today reported financial results for the three and nine months ended September 30, 2024. The Company also provided an update on its clinical development of IMNN-001 including progress toward commencing a Phase 3 study in advanced ovarian cancer, and an update on IMNN-101, its seasonal COVID-19 booster candidate. “The third quarter was a period of important milestones and outstanding progress for IMUNON, driven largely by presentation of highly compelling topline results from our OVATION 2 Study with IMNN-001 in advanced ovarian cancer,” said Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON. “In this study, treatment with IMNN-001 was associated with an overall survival improvement of 11.1 months compared to treatment with standard of care, and results were even stronger in the subset of patients who were also treated with PARP inhibitors. Building on this momentum, we have been highly encouraged by the interest in these results among global leaders from the medical and scientific communities. We have also engaged with the U.S. Food and Drug Administration to craft the design of our planned registrational study and are preparing for an in-person End-of-Phase 2 meeting with the agency later this month. We remain on track to begin our planned 500-patient pivotal Phase 3 study during the first quarter of 2025.” “Tomorrow afternoon we will be presenting new OVATION 2 data at the Society for Immunotherapy of Cancer 39th Annual Meeting. Our abstract is being highlighted as a late-breaking acceptance, so compelling that it was accepted after the deadline. Given the strength of the data, we are unsurprised with SITC’s decision to include our data for presentation. This is an exceptional opportunity to gain further awareness for IMNN-001 and our trial results.” “In summary, IMUNON is extraordinarily well-positioned to address the unmet need in a deadly cancer while also playing an important role in public health. We are justifiably excited about our prospects for patients and shareholders alike,” Dr. Lindborg concluded. RECENT DEVELOPMENTS IMNN-001 Immunotherapy Presenting Additional Phase 2 data for IMNN-001 at SITC – On October 30, 2024 the Company announced the acceptance of a late-breaking presentation featuring new clinical data from the Phase 2 OVATION 2 Study of IMNN-001 at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting, being held in Houston, TX. The presentation, titled “Phase I/II study of Safety and Efficacy of Intraperitoneal IMNN-001 with Neoadjuvant Chemotherapy of Paclitaxel and Carboplatin in Patients Newly Diagnosed with Advanced Epithelial Ovarian Cancer,” will be made on Friday, November 8, 2024 from 12:15-1:45 p.m. and 5:30-7:30 p.m. CST by Jennifer Scalici, M.D., Professor, Division of Gynecological Oncology, Emory University School of Medicine and a principal investigator in the trial. Imunon Ovarian Cancer R&D Day – On September 18, 2024 the company held an Ovarian Cancer R&D Day in New York City that included presentations from executive management and a panel of renowned leaders in research and patient care including: Sid Kerkar, M.D., T cell biology review editor, Frontiers in Immunology. Dr. Kerkar discussed the important role of interleukin-12 (IL-12) in treating cancer.William Bradley, M.D., Professor, Obstetrics and Gynecology, Gynecologic Oncology, Medical College of Wisconsin. Dr. Bradley discussed the safety and efficacy of IMNN-001.L.J. Wei, Ph.D., Professor of Biostatistics, Harvard T.H. Chan School of Public Health. Dr. Wei discussed the opportunity to combine progression-free survival (PFS) and overall survival (OS) to provide a clinically interpretable evaluation of the IMNN-001 treatment effect.Amir Jazaeri, M.D., Vice Chair for Clinical Research, Director, Gynecologic Cancer Immunotherapy Program, Department of Gynecologic Oncology and Reproductive Medicine, University of Texas MD Anderson Cancer Center. Dr. Jazaeri discussed the ongoing Phase 1/2 study of IMNN-001 in combination with bevacizumab in advanced ovarian cancer, for which he serves as principal investigator, including the importance of minimal residual disease and early translational insights.Premal Thaker, M.D., Interim Chief of Gynecologic Oncology, David & Lynn Mutch Distinguished Professor of Obstetrics & Gynecology, Director of Gynecologic Oncology Clinical Research, Washington University School of Medicine, and the OVATION 2 Study Chair. Dr. Thaker discussed the OVATION 2 topline results and their clinical significance. Positive topline results from the OVATION 2 Study in advanced ovarian cancer – On July 30, 2024, the Company announced topline results from the study that provide strong further validation of the potential safety and efficacy of IMNN-001 in the treatment of advanced ovarian cancer. Highlights from patients treated with IMNN-001 plus standard of care in a first-line treatment setting included: An 11.1 month increase in median OS compared with standard of care alone in the intent-to-treat (ITT) population.A hazard ratio in the ITT population of 0.74, which represents a 35% improvement in survival.Among the approximately 90% of trial participants who received at least 20% of specified treatments per-protocol in both study arms, patients in the IMNN-001 arm had a 15.7 month increase in median OS, representing a further extension of life with a hazard ratio of 0.64, a 56% improvement in survival.For the nearly 40% of trial participants treated with a poly ADP-ribose polymerase (PARP) inhibitor, the hazard ratio decreased further to 0.41, with median OS in the IMNN-001 treatment arm not yet reached at the time of database lock, compared with median OS of 37.1 months in the standard-of-care treatment arm. The PFS results, the trial’s primary endpoint, support the OS results with: A three-month improvement in PFS compared with standard of care alone.A hazard ratio in the ITT population of 0.79, indicating a 27% improvement in delaying progression for the IMNN-001 treatment arm. CORPORATE DEVELOPMENTS Raised gross proceeds of $10 million in a registered direct financing – On July 30, 2024, the Company entered into a Securities Purchase Agreement with certain institutional and accredited investors, pursuant to which the Company issued, in a registered direct offering, an aggregate of 5,000,000 shares of the Company’s common stock at an offering price of $2.00 per share for gross proceeds of $10.0 million. In a concurrent private placement (together with the registered direct offering) and also pursuant to the Securities Purchase Agreement, the Company issued to the Purchasers unregistered warrants to purchase shares of common stock. The warrants have an exercise price of $2.00 per share and became exercisable immediately after the issuance for a term of five and one-half years following the date of issuance. The closing of the registered direct offering occurred on August 1, 2024. Additions to leadership team to ensure operational excellence and support future plans – On October 7, 2024, Susan Eylward was named General Counsel and Corporate Secretary. She was most recently Senior Counsel at Science 37, Inc., a solutions organization focused on decentralized clinical trials, where she was responsible for a variety of complex legal matters, including corporate governance, securities compliance, executive compensation and acquisitions. Kristin Longobardi was named Senior Vice President of Operations, bringing more than two decades of experience in enhancing business processes and operations across the biotech and pharmaceutical sectors. Previously, she served as Vice President of R&D Quality, Operations and Performance at Biogen. Her expertise in portfolio management, financial planning and operational excellence will be pivotal in driving IMUNON’s operational frameworks toward supporting ambitious company growth. THIRD QUARTER FINANCIAL RESULTS The Company had $10.3 million in cash, investments and accrued interest receivable as of September 30, 2024. The Company believes it has sufficient capital resources to fund its operations into the third quarter of 2025. Research and development expenses were $3.3 million for the third quarter of 2024, compared with $2.0 million for the third quarter of 2023. General and administrative expenses were $1.7 million for the third quarter of 2024, compared with $1.9 million for the third quarter of 2023. Net loss was $4.9 million, or $0.34 per share, for the third quarter of 2024, compared with a net loss of $3.5 million, or $0.37 per share, for the third quarter of 2023. YEAR-TO-DATE FINANCIAL RESULTS Research and development expenses were $9.4 million for the nine months ended September 30, 2024, compared with $7.7 million for the nine months ended September 30, 2023. General and administrative expenses were $5.6 million for the nine months ended September 30, 2024, compared with $7.3 million for nine months ended September 30, 2023. Year-to-date net loss was $14.6 million, or $1.39 per share, compared with a net loss of $14.6 million, or $1.64 per share, for the same period of 2023. Conference Call and Webcast The Company is hosting a conference call at 11:00 a.m. ET today to provide a business update, discuss third quarter 2024 financial results and answer questions. To participate in the call, please dial 833-816-1132 (Toll-Free/North America) or 412-317-0711 (International/Toll) and ask for the IMUNON third quarter 2024 earnings call. A live webcast of the call will be available here. The call will be archived for replay until November 21, 2024. The replay can be accessed at 877-344-7529 (U.S. Toll-Free), 855-669-9658 (Canada Toll-Free) or 412-317-0088 (International Toll), using the replay access code 10193110. A webcast of the call will be available here for 90 days. 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 Phase 2 development. 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 entered a first-in-human study of its COVID-19 booster vaccine (IMNN-101). IMUNON will continue to leverage these modalities and to advance the technological frontier of plasmid DNA to better serve patients with difficult-to-treat conditions, and to further strengthen IMUNON’s balance sheet through attractive business development opportunities. 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 for commencement of a Phase 3 trial of IMNN-001, the timing and outcome of the Company’s End-of-Phase 2 meeting with the FDA, the timing and 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 of 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: MediaInvestorsCG LifeICR HealthcareJenna UrbanPeter Vozzo212-253-8881443-213-0505jurban@cglife.competer.vozzo@westwicke.com (Tables to Follow) IMUNON, Inc.Condensed Statements of Operations(in thousands except per share amounts) Three Months EndedSeptember 30, Nine Months EndedSeptember 30, 2024 2023 2024 2023 Operating expenses: Research and development $3,293 $1,981 $9,407 $7,735 General and administrative 1,668 1,923 5,579 7,328 Total operating expenses 4,961 3,904 14,986 15,063 Loss from operations (4,961) (3,904) (14,986) (15,063) Other income (expense): Investment income 116 427 423 962 Interest expense - - - (197)Loss on debt extinguishment - - - (329)Total other (expense) income, net 116 427 423 436 Net loss $(4,845) $(3,477) $(14,563) $(14,627) Net loss per common share Basic and diluted $(0.34) $(0.37) $(1.39) $(1.64) Weighted average shares outstanding Basic and diluted 14,445 9,377 10,503 8,926 IMUNON, Inc.Selected Balance Sheet Information(in thousands) ASSETS September 30,2024 December 31,2023 Current assets Cash and cash equivalents $10,312 $5,839 Investment securities and interest receivable - 9,857 Advances, deposits and other current assets 2,220 2,545 Total current assets 12,532 18,241 Property and equipment 564 752 Other assets Deferred tax asset - 1,280 Operating lease right-of-use assets, net 1,245 1,595 Deposits and other assets 50 50 Total other assets 1,295 2,925 Total assets $14,391 $21,918 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities Accounts payable – trade accrued liabilities $2,360 $3,515 Other accrued liabilities 2,573 3,391 Operating lease liabilities – current portion 509 485 Total current liabilities 5,442 7,391 Operating lease liabilities – non-current portion 758 1,139 Total liabilities 6,200 8,530 Stockholders' equity Common stock 145 94 Additional paid-in capital 410,877 401,501 Accumulated other comprehensive gain (loss) - 61 Accumulated deficit (402,746) (388,183) 8,276 13,473 Less: Treasury stock (85) (85) Total stockholders' equity 8,191 13,388 Total liabilities and stockholders' equity $14,391 $21,918 # # #