Full Press Release Details
Reports Second Quarter 2025 Financial Results and
dividend issued to IMUNON shareholders reflects confidence in clinical programs, long-term growth strategy and dedication to rewarding
patient dosed in Phase 3 OVATION 3 Study of IMNN-001 for treatment of newly diagnosed advanced ovarian cancer
to hold conference call today at 11:00 a.m. ET
N.J., August 5, 2025 - IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated
immunotherapy, today reported financial results for the three-month and six-month periods ended June 30, 2025, and highlighted recent
business updates, including progress in advancing Phase 3 clinical development of its lead candidate IMNN-001 in newly diagnosed advanced
continues to make significant progress in advancing its mission to transform cancer treatment," said Stacy Lindborg, Ph.D., president
and chief executive officer of IMUNON. "With groundbreaking IMNN-001 clinical data, a clear clinical development and regulatory
strategy, including a Phase 3 trial currently in progress, and significant unmet patient need, IMUNON is well positioned to potentially
deliver an innovative therapy for women with newly diagnosed advanced ovarian cancer who urgently need new treatment options."
clinical success has attracted increasing interest from potential institutional investors and from potential partners, reflecting confidence
in our technology and business strategy. As we advance the Phase 3 OVATION 3 Study, which will evaluate IMNN-001 in women with stage
IIIC or IV ovarian cancer, we are committed to funding this pivotal trial strategically. We have taken steps to conserve cash and align
our critical needs with available capital on hand, while securing the resources needed to advance this potentially transformative therapy
with select financing opportunities," Dr. Lindborg continued.
Patient Dosed in the Phase 3 OVATION 3 Study of IMNN-001 in Newly Diagnosed Advanced Ovarian Cancer - On July 30, 2025, the
Company announced treatment of the first patient in the OVATION 3 Study and is working with trial investigators to expand clinical sites
and accelerate enrollment. Three sites have been activated and are open for patient enrollment, with a corporate goal of having 20 sites
activated by the end of 2025.
Phase 3 OVATION 3 trial will assess the safety and efficacy of IMNN-001 (100 mg/m2 administered intraperitoneally weekly)
plus neoadjuvant and adjuvant chemotherapy (N/ACT) of paclitaxel and carboplatin compared to standard of care (SoC) N/ACT alone. Study
participants will be randomized 1:1 and include women with newly diagnosed advanced ovarian cancer (stage 3C or 4) who are eligible for
neoadjuvant therapy, the intent-to-treat (ITT) population, with a sub-group of women positive for homologous recombination deficiency
(HRD), including BRCA1 or BRCA2 mutations. Participants who are HRD positive will receive poly ADP-ribose polymerase (PARP) inhibitors
as part of standard maintenance therapy. The primary endpoint of the study is overall survival (OS), and secondary endpoints are surgical
response score, chemotherapy response score, clinical response and time to second-line treatment. The study will also assess several
exploratory endpoints.
Presentation of Phase 2 OVATION 2 Study at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting Reinforces Unprecedented
Overall Survival IMNN-001 Data in Advanced Ovarian Cancer - During an oral presentation at the 2025 American Society of Clinical
Oncology (ASCO) Annual Meeting in Chicago, Illinois on June 3, 2025, the Company presented positive data from its Phase 2 OVATION 2 Study
showing that treatment with IMNN-001 in women with newly diagnosed advanced ovarian cancer resulted in consistent, clinically meaningful
improvements in several key endpoints across treatment groups, including OS, progression-free survival (PFS), chemotherapy response score
and surgical response. Treatment with IMNN-001 also showed a favorable safety profile, with no elevation in immune-related adverse events.
The review of full data was simultaneously published in the peer-reviewed journal Gynecologic Oncology, titled OVATION-2: A
Randomized Phase I/II study Evaluating the Safety and Efficacy of IMNN-001 (IL-12 gene therapy) with Neo/Adjuvant Chemotherapy in Patients
Newly- Diagnosed with Advanced Epithelial Ovarian Cancer.
data presented at ASCO 2025 and published in Gynecologic Oncology demonstrated consistent results across all treatment groups,
with the following key highlights:
| Patients in the intent-to-treat (ITT) population administered IMNN-001 plus SoC N/ACT achieved a median increase in OS of 13 months compared to SoC N/ACT alone (46 vs. 33 months), with a hazard ratio of 0.69. | ||
| Better therapeutic effect observed with IMNN-001 treatment compared to the control arm (p=0.0375), as shown by mean 6.5-month extension of time free of progression or death (PFS + OS) captured in totality of treatment effect. | ||
| Use of PARP inhibitors as part of maintenance therapy further enhanced outcomes, with median OS not yet reached in IMNN-001 treatment arm after more than five years (vs. 37 months in the control arm), with a hazard ratio of 0.38. |
additional details, please refer to our press release (Press Release). The OVATION 2 Study oral presentation and journal
manuscript are both available on the "Scientific Presentations" page of IMUNON's website at https://investors.imunon.com/scientific-presentations.
Phase 2 Translational Data of IMNN-001 in Advanced Ovarian Cancer Presented at ESMO Gynaecological Cancers Congress 2025 -
On June 18, 2025, at the ESMO Gynaecological Cancers Congress 2025, the Company presented new positive translational data from the Phase
2 OVATION 2 Study of IMNN-001, its investigational gene-based interleukin-12 (IL-12) immunotherapy based on its proprietary TheraPlas
technology platform, for the treatment of newly diagnosed advanced ovarian cancer. The data demonstrated that IMNN-001 creates a "hot"
anti-tumor microenvironment by recruiting CD8+ T cells, macrophages and dendritic cells into the tumor microenvironment and decreasing
Treg suppressor cells. This biomarker research further validates IMNN-001's mechanism of action and selective immune activation
DNA Vaccine Technology
Data Show Durability of Protection for Next-Generation DNA Vaccine Platform in Phase 1 Clinical Trial in COVID-19 - On May
15, 2025, we announced six-month data from the Phase 1 proof-of-concept trial of IMNN-101, our investigational DNA plasmid vaccine based
on the Company's proprietary PlaCCine platform. In 24 healthy volunteers previously vaccinated against the Omicron XBB1.5 variant,
a single dose targeting this antigen induced up to a 3-fold median increase in serum neutralizing antibody (NAb) titers from baseline
at six months, with stronger responses in the higher dose cohorts (2.0 mg and 1.0 mg) compared to the lower dose (0.5 mg). The highest
observed individual increase was 8-fold from baseline among the participating volunteers. Modest T-cell response increases were also
observed in trial participants who received multiple immunizations prior to the study. IMNN-101 remained safe and well-tolerated, with
no serious adverse events reported.
results build on February 2025 data showing a persistent 2- to 4-fold NAb titer increase through week 4, with further gains between weeks
2 and 4, and cross-reactivity against XBB1.5 and newer variants. The findings align with preclinical data demonstrating more than 95%
protection in non-human primates, comparable to mRNA vaccines. PlaCCine's demonstrated advantages include durability of protection,
simplified manufacturing, and stability (up to one year at 4 C and one month at 37 C), positioning it as a potential alternative
to mRNA vaccines. Given our strategic deprioritization of this program, the Company plans to seek partners for further development of
Announces Stock Dividend Boosting Shareholder Value - On July 28, 2025, the Company announced a 15% stock dividend, 0.15 shares
of common stock per share of common stock and per each common stock equivalent with dividend rights. This stock grant reflects IMUNON's
confidence in its clinical programs, long-term growth strategy, and its dedication to rewarding shareholders. The stock dividend program
will distribute a total of approximately 448,000 shares of additional shares of IMUNON common stock for each share (or common stock equivalent)
held, payable to such holders of record as of August 7, 2025. The distribution is expected to occur on August 21, 2025.
To $9.75 Million Private Placement Offering Priced At-The-Market - On May 28, 2025, the Company announced the sale of common
stock and short-term warrants at a purchase price of $0.45 per share in a private placement priced at-the-market under Nasdaq rules.
The aggregate gross proceeds to the Company from the private placement was approximately $3.25 million, before deducting placement agent
fees and other offering expenses payable by the Company. The potential additional gross proceeds to the Company from the short-term warrants,
if fully exercised on a cash basis, will be approximately $6.50 million. The Company intends to use the net proceeds from the offering
for working capital focused on the pivotal Phase 3 OVATION 3 Study of IMNN-001 and general corporate purposes. The short-term warrants
became exercisable on July 11, 2025, the effective date of stockholder approval of the issuance of the shares of common stock upon exercise
of the warrants and have a three-year term.
Listing Extension Granted by Nasdaq to Complete Compliance Plan - On July 15, 2025, the Company announced that the Nasdaq Hearing
Panel has granted its request for an exception to complete its compliance plan, allowing the Company to maintain its listing on the Nasdaq
Stock Market. Following a comprehensive review of IMUNON's strategies to regain compliance, the Nasdaq Hearing Panel stated that
IMUNON has already achieved compliance with the Equity Rule through recent fundraising activities. To ensure sustained compliance with
the minimum shareholder equity requirement and to regain compliance with the minimum bid price requirement, the Company will implement
the compliance plan recently presented to the Hearing Panel. The Panel has approved an exception tailored to the time needed for IMUNON
to regain compliance, rather than the full 180-day period initially requested. The Company is committed to meeting these requirements
within the designated timeframe. Should additional time be necessary, IMUNON may submit a request for an extension to the Panel.
Reverse Stock Split and Increase in Authorized Shares - On July 25, 2025, the Company announced a 15-for-1 reverse stock split
of its common stock, which was made effective for trading purposes as of 12:01 a.m. ET on July 25, 2025. All shares have been restated
to reflect the effects of the 15-for-1 reverse stock split. Immediately prior to the reverse stock split, the Company had 31,828,425
shares of common stock outstanding which consolidated into 2,121,895 shares of the Company's common stock. The reverse stock split
did not impact the total authorized number of shares of common or preferred stock or the par value thereof. The number of outstanding
options, stock awards and warrants were adjusted accordingly, with outstanding options and stock awards being reduced from approximately
1.9 million to approximately 0.1 million and outstanding warrants being reduced from approximately 12.7 million to approximately 0.8
at the Company's 2025 Annual Meeting of Stockholders held on July 11, 2025, IMUNON stockholders approved an amendment to the Company's
Restated Certificate of Incorporation to increase the number of authorized shares of common stock from 112,500,000 shares to 350,000,000
shares, and to make a corresponding change to the number of authorized shares of capital stock.
QUARTER 2025 FINANCIAL RESULTS
note: All share amounts and per share amounts in this press release have been adjusted to reflect a 15-for-1 reverse split of our common
stock, which we effected on July 25, 2025.
loss for the second quarter of 2025 was $2.7 million, or $2.15 per share, compared with a net loss of $4.8 million, or $7.64 per share,
for the second quarter of 2024. Operating expenses were $2.8 million for the second quarter of 2025, a decrease of $2.2 million or 45%
from $5.0 million for the second quarter of 2024.
and development (R&D) expenses were $1.2 million for the second quarter of 2025, a decrease of $1.6 million from $2.8 million for