Tillkännagivande • Nov 15

Imunon, Inc. Provides an Update on Its Clinical Development Programs with Imnn-001 (Formerly Gen-1), A Dna-Based Interleukin-12 (Il-12) Immunotherapy in Phase 2 Clinical Development for the Treatment of First-Line Locally Advanced Ovarian Cancer

Imunon, Inc. provided an update on its clinical development programs with IMNN-001 (formerly GEN-1), a DNA-based interleukin-12 (IL-12) immunotherapy in Phase 2 clinical development for the treatment of first-line locally advanced ovarian cancer; on its PlaCCine modality, a proprietary mono- or multi-cistronic non-viral and synthetic DNA technology for the expression of pathogen antigens in preclinical studies for the development of next-generation vaccines; and on the early developments with its new FixPlas modality for cancer vaccines. Reported Interim PFS and OS Data in OVATION 2 Study in Advanced Ovarian Cancer. In September 2023, the Company announced interim PFS and OS data with IMNN-001 in its OVATION 2 Study. This study is evaluating the dosing, safety, efficacy and biological activity of intraperitoneal IMNN-001 in combination with NACT in patients newly diagnosed with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer. NACT 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 chemotherapy to treat any residual tumor. The study is directional and designed with an 80% confidence interval to show an approximate 33% improvement in PFS, when comparing the treatment arm (NACT + IMNN-001) with the control arm (NACT only). The secondary endpoints include OS, objective response rate (ORR), pathological response, surgical response and serologic response. The final readout of this study is expected in mid-2024. A positive readout would inform next development steps. Interim data from the ITT population showed efficacy trends in PFS, demonstrating a delay in disease progression in the treatment arm of approximately 33% compared with the control arm, with the hazard ratio nearing the per protocol value. Preliminary OS data follows a similar trend, showing an approximate nine-month improvement in the treatment arm over the control arm. Subgroup analyses show patients treated with a PARPi as maintenance therapy had longer PFS and OS if they were also treated with IMNN-001, compared with patients treated with NACT only. The median PFS in the PARPi + NACT group and the PARPi + NACT + IMNN-001 group was 15.7 months and 23.7 months, respectively. The median OS in the PARPi + NACT group was 45.6 months and has not yet been reached in the PARPi + NACT + IMNN-001 group. Continued benefits were seen in other secondary endpoints including an approximately 20% higher R0 tumor resection score and a doubling of the CRS 3 chemotherapy response score to approximately 30% in the treatment arm, versus 14% in the control arm. A complete tumor resection (R0) is a microscopically margin-negative resection in which no gross or microscopic tumor remains in the tumor bed. Chemotherapy response score is considered a good prognostic indicator in ovarian cancer. Safety analyses continue to show good tolerability of IMNN-001 in this setting. Began Treatment in a Phase 1/2 Clinical Trial Evaluating IMNN-001 in Combination with Bevacizumab in Advanced Ovarian Cancer. In October 2023, the first patient was enrolled in this trial at the University of Texas MD Anderson Cancer Center, which is expected to enroll 50 patients with Stage III/IV ovarian cancer. Patients undergoing frontline neoadjuvant therapy will be randomized 1:1 to receive standard chemotherapy plus bevacizumab, or standard chemotherapy plus bevacizumab and IMNN-001. The trial’s primary endpoint is detection of minimal residual disease (MRD) by second look laparoscopy (SLL), and the secondary endpoint is PFS. Initial SLL data are expected within one year following the completion of enrollment and final PFS data are expected approximately three years following the completion of enrollment. This trial will also include a wealth of translational endpoints aimed at understanding the clonal evolution and immunogenomic features of the MRD phase of ovarian cancer that is currently undetectable by imaging or tumor markers. Chief Science Officer Presented at the 3rdInternational Vaccines Congress. In October 2023, Khursheed Anwer, Ph.D. delivered a presentation titled “A DNA-based Vaccine Technology Independent of Virus or Device,” which described the multiple advantages of the PlaCCine modality over current commercial vaccine platforms. The presentation also described the versatility of the PlaCCine modality, demonstrating the activity against Marburg and influenza viruses in collaboration with the Wistar Institute, and activity against Lassa virus being evaluated at the NIH/NIAID. Entered into a CRADA for Preclinical Studies of the PlaCCine Modality in Preventive Vaccines Against Lassa Virus. In August 2023, the Company announced it entered into a CRADA with the NIAID to evaluate the immunogenicity and efficacy of two IMUNON DNA-based Lassa virus vaccine candidates in animal models. Under the three-year agreement, the NIAID will assess the efficacy of PlaCCine DNA constructs against Lassa virus in guinea pig and non-human primate disease models, including both prime and prime-boost vaccine strategies. The Laboratory of Virology at the NIAID is researching a potential solution for combatting this life-threatening pathogen by evaluating a DNA-based vaccine approach for the treatment of the Lassa virus due to its durable antigen expression, longer shelf-life at workable, standard refrigerated temperatures and flexible manufacturing to potentially address the limitations of current commercial products, particularly in developing countries. Preclinical Data with PlaCCine DNA-based Vaccines Modality Published Online on bioRxiv. In August 2023, a manuscript titled “Strong immunogenicity & protection in mice with PlaCCine: A COVID-19 DNA vaccine formulated with a functional polymer” was published on the preprint server bioRxiv [here]. The study used IMUNON’s proprietary formulation against the spike proteins from two SARS-CoV-2 variants, both alone and in combination. These results add to the growing body of preclinical data confirming the efficacy and desirable features of IMUNON’s PlaCCine vaccine modality. Data from the study show: IMUNON’s proprietary formulation of functionalized polymer protected DNA from degradation, while the combination with an adjuvant led to an increase in protein expression DNA formulated with PlaCCine resulted in a DNA vaccine product that was stable for up to one year at 4°C, one month at room temperature and over two weeks at 38°C DNA formulated in PlaCCine resulted in the induction of spike-specific neutralizing antibodies and cytotoxic T cells In the in vivo challenge model, the vaccine-induced immune response was capable of suppressing viral replication Multiple inserts can be cloned into the PlaCCine backbone (a plug-and-play strategy), therefore allowing for an immune response with broader protection.

Räntetäckningsgrad	n/a
Kontanter	US$4.79m
Eget kapital	US$3.36m
Summa skulder	US$4.66m
Totala tillgångar	US$8.02m

Uppgifter	Senast uppdaterad (UTC-tid)
Analys av företag	2026/08/06 22:18
Aktiekurs vid dagens slut	2026/08/06 00:00
Intäkter	2026/03/31
Årlig intjäning	2025/12/31

Paket	Uppgifter	Tidsram	Exempel US-källa
Företagets finansiella ställning	10 år	Resultaträkning Kassaflödesanalys Balansräkning	SEC Form 10-K SEC Form 10-Q
Analytikernas konsensusuppskattningar	+3 år	Prognos för finansiella poster Analytikernas prismål	Rapporter från analytiker Blue Matrix
Marknadspriser	30 år	Aktiekurser Utdelningar, splittar och åtgärder	ICE Marknadsdata SEC Form S-1
Ägarskap	10 år	Största aktieägare Insiderhandel	SEC Formulär 4 SEC Formulär 13D
Förvaltning	10 år	Ledningsgrupp Styrelse och verkställande direktörer	SEC Form 10-K SEC Form DEF 14A
Viktiga utvecklingstendenser	10 år	Företagsmeddelanden	SEC Formulär 8-K

Analytiker	Institution
James Molloy	Alliance Global Partners
Brian Kemp Dolliver	Brookline Capital Markets
Kumaraguru Raja	Brookline Capital Markets

Imunon Balansräkning Hälsa

Finansiell hälsa kriterier kontrolleras 6/6

Viktig information

Nya uppdateringar om finansiell hälsa

IMUNON Successfully Regains Compliance with Nasdaq Minimum Bid Price Listing Requirement

Imunon, Inc. Announces Non-Compliance Update

Imunon Receives Notice of Delisting Due to Non-Compliance with Nasdaq Requirements

Imunon Receives a Letter from the Staff of the Nasdaq Stock Market

Imunon, Inc. Receives Non-Compliance Letter Regarding Nasdaq Listing Rule 5550(a)(2)

Imunon Receives Non-Compliance Notice From Nasdaq

Recent updates

Imunon, Inc. to Report Q2, 2026 Results on Aug 04, 2026

IMUNON Reports Strong Enrollment Momentum In Phase 3 OVATION 3 Trial Of IMNN-001 In Advanced Ovarian Cancer

Imunon, Inc. Announces Chief Financial Officer Changes, Effective July 1, 2026

IMNN: Bullish View Will Hinge On Pivotal Ovarian Cancer Survival Data

IMUNON Inc. Continues Phase 3 OVATION 3 Clinical Trial Of IMNN-001 In Combination With Standard Of Care Chemotherapy

Imunon, Inc. announced that it has received $10 million in funding from Streeterville Capital, LLC

New major risk - Market cap size

Price target decreased by 70% to US$19.20

Insufficient new directors

Imunon, Inc., Annual General Meeting, Jun 16, 2026

Imunon Inc Reports Updated Phase 2 Data Showing Continued Improvement In Median Overall Survival With IMNN-001 In Women With Newly Diagnosed Advanced Ovarian Cancer

Frontline Ovarian Cancer Trial Success Will Transform Long Term Potential For This IL 12 Therapy

Phase III Ovarian Cancer Trial And IL-12 Focus Will Reshape This Long-Term Thesis

Imunon, Inc. Eliminates Headcount Not Essential to Phase 3 Trial

Imunon, Inc. Announces Chief Financial Officer Changes, Effective January 14, 2026

Imunon, Inc. has filed a Follow-on Equity Offering in the amount of $7.000041 million.

New major risk - Market cap size

IMUNON R&D Day Showcases Clinical Progress of Its Novel Immunotherapy, Phase 3 Trial and Significant Potential for Women with Ovarian Cancer

IMUNON, Inc. to Present New Translational Data from Phase 2 Ovarian Cancer at SITC 40th Annual Meeting

IMUNON, Inc. to Present Phase 3 Ovarian Cancer Study of IMNN-001 at ESMO Congress

Insufficient new directors

IMUNON Presents IMNN-001 Phase 2 Translational Data in Advanced Ovarian Cancer Demonstrating 13-Month Os Extension Via Tumor Micro- Environment Shift

Imunon to Present New Translational Data of IMNN-001 Supporting Phase 3 Trial of Immunotherapy for Ovarian Cancer At AACR Special Conference in Cancer Research

IMUNON Successfully Regains Compliance with Nasdaq Minimum Bid Price Listing Requirement

Price target decreased by 11% to US$119

New major risk - Financial position

Imunon, Inc. Announces First Patient Dosed in Phase 3 Ovation 3 Study of Imnn-001 in Newly Diagnosed Advanced Ovarian Cancer

New major risk - Market cap size

Imunon, Inc. Announces Non-Compliance Update

IMUNON, Inc. Presents Positive Phase 2 Translational Data of IMNN-001 in Advanced Ovarian Cancer at ESMO Gynaecological Cancers Congress 2025

Imunon, Inc. Announces Data Presented at ASCO Reinforces Unprecedented Overall Survival in Ovarian Cancer Phase 2 Study

Imunon, Inc., Annual General Meeting, Jul 11, 2025

Imunon Receives Notice of Delisting Due to Non-Compliance with Nasdaq Requirements

Imunon, Inc. announced that it has received $3.250001 million in funding

IMUNON, Inc. to Present Translational Data in Supporting Remarkable Phase 2 Ovarian Cancer Survival Results at ESMO Gynaecological Cancers Congress 2025

IMUNON Announces 2025 ASCO Annual Meeting Highlighting Unprecedented Survival Data from Phase 2 Trial of IMNN-001 in Treatment of Newly Diagnosed Advanced Ovarian Cancer

Imunon, Inc. has withdrawn its Follow-on Equity Offering.

Imunon Receives a Letter from the Staff of the Nasdaq Stock Market

New minor risk - Share price stability

New major risk - Market cap size

IMUNON Announces Six-Month Data Showing Durability of Protection for Next-Generation DNA Vaccine Platform in Phase 1 Clinical Trial in COVID-19

Price target decreased by 15% to US$11.20

IMUNON, Inc. Announces First Site Initiated for Pivotal Phase 3 OVATION 3 Study of IMNN-001 in Newly Diagnosed Advanced Ovarian Cancer

IMUNON Announces Data from Phase 1/2 Trial Evaluating Intraperitoneal IMNN-001 in Combination with Neoadjuvant Chemotherapy in Newly Diagnosed Patients with Advanced Epithelial Ovarian Cancer to Be Published in Gynecologic Oncology

Imunon Announces Imnn-001 Abstract Accepted for Oral Presentation

Imunon, Inc. has filed a Follow-on Equity Offering.

Imunon, Inc. Finalizes Phase 3 Study Design with FDA for IMNN-001 in Newly Diagnosed Advanced Ovarian Cancer

Imunon, Inc. Announces New Immunogenicity Data from Phase 1 Clinical Trial of Its DNA Vaccine in Treatment of COVID-19

Imunon, Inc. to Report Fiscal Year 2024 Results on Feb 27, 2025

IMUNON, Inc. Announces Translational Data from Phase 1/2 OVation 2 Study of IMNN-001 in Advanced Ovarian Cancer

Imunon Appoints Douglas V. Faller as Chief Medical Officer, Effective February 18, 2025

IMUNON, Inc. Announces Positive CMC Meeting with FDA for IMNN-001 in Treatment of Advanced Ovarian Cancer

Imunon Announces Continued Strong Improvement in Overall Survival Data from Randomized Phase 2 Ovation 2 Study of Imnn-001

Imunon, Inc. Receives Non-Compliance Letter Regarding Nasdaq Listing Rule 5550(a)(2)

Imunon, Inc. Announces Results from its End-Of-Phase 2 Meeting with the FDA for its Lead IMNN-001 Clinical Program in Advanced Ovarian Cancer

New major risk - Market cap size

New major risk - Financial position

IMUNON, Inc. Announces the Presentation of New Clinical Data from the Recently Completed Phase 2 Study of IMNN-001

Imunon, Inc. to Report Q3, 2024 Results on Nov 07, 2024

IMUNON, Inc. to Present Phase 2 Data of IMNN-001 in Treatment of Newly Diagnosed Ovarian Cancer at SITC 39th Annual Meeting

Imunon, Inc. Appoints Susan Eylward as General Counsel and Corporate Secretary

Imunon, Inc. has withdrawn its Follow-on Equity Offering in the amount of $5.5 million.

Price target decreased by 11% to US$9.75

New major risk - Shareholder dilution

Imunon, Inc. has filed a Follow-on Equity Offering in the amount of $10 million.

Imunon, Inc. Announces Database Lock for Phase 2 OVATION 2 Study with IMNN-001 in Advanced Ovarian Cancer

IMUNON, Inc. Announces First Participants Vaccinated in IMNN-101 Phase 1 Clinical Trial

Price target decreased by 17% to US$10.00

IMUNON, Inc. Announces Site Activation for IMNN-101 Phase 1 Vaccine Study