IMUNON Reports Second Quarter 2025 Financial Results and Provides Business Update
Rhea-AI Summary
IMUNON (NASDAQ: IMNN) reported Q2 2025 financial results and significant progress in its clinical programs. The company announced a 15% stock dividend and dosed the first patient in its Phase 3 OVATION 3 Study of IMNN-001 for advanced ovarian cancer.
Q2 2025 financial highlights include a net loss of $2.7 million ($2.15 per share), improved from $4.8 million loss in Q2 2024. Operating expenses decreased 45% to $2.8 million. Cash position stands at $4.7 million, with additional $3.1 million raised in July 2025.
Key developments include positive Phase 2 OVATION 2 Study data showing 13-month median OS improvement, successful completion of a $9.75 million private placement, and a Nasdaq listing compliance extension. The company implemented a 15-for-1 reverse stock split effective July 25, 2025.
Positive
- 15% stock dividend announced for shareholders
- Phase 2 OVATION 2 Study showed 13-month median OS improvement (46 vs. 33 months)
- Operating expenses decreased 45% year-over-year to $2.8M in Q2 2025
- Secured up to $9.75M through private placement offering
- Received Nasdaq continued listing extension
- Positive Phase 2 translational data showing enhanced immune response
Negative
- Net loss of $2.7M in Q2 2025
- Cash position of only $4.7M, funding operations only into Q4 2025
- Required 15-for-1 reverse stock split to maintain listing compliance
- Deprioritization of COVID-19 vaccine program (IMNN-101)
News Market Reaction
On the day this news was published, IMNN declined 4.78%, reflecting a moderate negative market reaction. Argus tracked a trough of -5.7% from its starting point during tracking. Our momentum scanner triggered 6 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $980K from the company's valuation, bringing the market cap to $20M at that time.
Data tracked by StockTitan Argus on the day of publication.
Stock dividend issued to IMUNON shareholders reflects confidence in clinical programs, long-term growth strategy and dedication to rewarding shareholders
First patient dosed in Phase 3 OVATION 3 Study of IMNN-001 for treatment of newly diagnosed advanced ovarian cancer
Company to hold conference call today at 11:00 a.m. ET
LAWRENCEVILLE, N.J., Aug. 05, 2025 (GLOBE NEWSWIRE) -- 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 ovarian cancer.
“IMUNON 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.”
“Our 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.
RECENT DEVELOPMENTS
IMNN-001 Immunotherapy
First 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.
The 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.
Oral 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.
The 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.
For 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.
Positive 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 at the tumor site.
PlaCCine®DNA Vaccine Technology
Six-Month 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.
These 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
Corporate Highlights
IMUNON Announces Stock Dividend Boosting Shareholder Value – On July 28, 2025, the Company announced a
Up To
Continued 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.
Effected 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 million.
Also 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.
SECOND QUARTER 2025 FINANCIAL RESULTS
Please 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.
Net loss for the second quarter of 2025 was
Research and development (R&D) expenses were
General and administrative (G&A) expenses were
Investment income from short-term investments was
As of June 30, 2025, cash and cash equivalents were
FIRST HALF OF 2025 FINANCIAL RESULTS
Please 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.
For the six months ended June 30, 2025, the Company reported a net loss of
Net cash used for operating activities was
R&D expenses were
G&A expenses were
Other non-operating income was
Conference Call and Webcast
The Company is hosting a conference call to review second quarter 2025 financial results and provide a business update today, August 5, 2025, at 11:00 a.m. ET. 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 Second Quarter 2025 Financial Results Call. A live webcast of the call will also be available here.
The call will be archived for replay until August 19, 2025. 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 replay access code 9465184. An audio replay of the call will also 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 multiple clinical trials including one Phase 2 clinical trial (OVATION 2). The first patient was dosed in the Company’s Phase 3 pivotal study, called OVATION 3, in the third quarter of 2025. 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 Company’s ability to regain compliance with Nasdaq’s continued listing requirements, 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), and include statements regarding our planned stock split. Readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, risks and uncertainties related to the reverse stock split having the desired effect, our ability to regain compliance with Nasdaq’s listing requirements, the potential de-listing of our shares on Nasdaq, risks and 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 | |
| CG Life | ICR Healthcare | |
| Jenna Urban | Peter Vozzo | |
| 212-253-8881 | 443-213-0505 | |
| jurban@cglife.com | peter.vozzo@icrhealthcare.com |
(Tables to Follow)
IMUNON, Inc.
Condensed Statements of Operations
(in thousands except per share amounts)
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 1,227 | $ | 2,819 | $ | 3,392 | $ | 6,114 | ||||||||
| General and administrative | 1,541 | 2,194 | 3,521 | 3,911 | ||||||||||||
| Total operating expenses | 2,768 | 5,0134 | 6,913 | 10.025 | ||||||||||||
| Loss from operations | (2,768 | ) | (5,013 | ) | (6,913 | ) | (10,025 | ) | ||||||||
| Other income: | ||||||||||||||||
| Investment Income | 27 | 225 | 70 | 307 | ||||||||||||
| Total other income | 27 | 225 | 70 | 307 | ||||||||||||
| Net loss | $ | (2,741 | ) | $ | (4,788 | ) | $ | (6,843 | ) | $ | (9,718 | ) | ||||
| Net loss per common share | ||||||||||||||||
| Basic and diluted | $ | (2.15 | ) | $ | (7.64 | ) | $ | (6.08 | ) | $ | (15.51 | ) | ||||
| Weighted average shares outstanding | ||||||||||||||||
| Basic and diluted | 1,277 | 627 | 1,124 | 627 | ||||||||||||
IMUNON, Inc.
Selected Balance Sheet Information (in thousands)
| June 30, 2025 | December 31, 2024 | |||||||
| ASSETS | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 4,729 | $ | 5,873 | ||||
| Advances, deposits on clinical programs and other current assets | 2,162 | 2,136 | ||||||
| Total current assets | 6,891 | 8,009 | ||||||
| Property and equipment | 677 | 541 | ||||||
| Other assets | ||||||||
| Operating lease right-of-use assets | 1,170 | 1,117 | ||||||
| Deposits and other assets | 50 | 50 | ||||||
| Total other assets | 1,220 | 1,167 | ||||||
| Total assets | $ | 8,788 | $ | 9,717 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities | ||||||||
| Accounts payable and accrued liabilities | $ | 4,935 | $ | 4,334 | ||||
| Operating lease liability – current portion | 382 | 452 | ||||||
| Total current liabilities | 5,317 | 4,786 | ||||||
| Operating lease liability – noncurrent portion | 811 | 687 | ||||||
| Total liabilities | 6,128 | 5,473 | ||||||
| Stockholders’ equity | ||||||||
| Common stock | 17 | 9 | ||||||
| Additional paid-in capital | 416,374 | 411,123 | ||||||
| Accumulated deficit | (413,646 | ) | (406,803 | ) | ||||
| 2,745 | 4,329 | |||||||
| Less: Treasury stock | (85 | ) | (85 | ) | ||||
| Total stockholders’ equity | 2,660 | 4,244 | ||||||
| Total liabilities and stockholders’ equity | $ | 8,788 | $ | 9.717 | ||||
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FAQ
What were IMUNON's (IMNN) key financial results for Q2 2025?
What were the Phase 2 OVATION 2 Study results for IMNN-001 in ovarian cancer?
How will IMUNON's 15% stock dividend work and when will it be distributed?
What is the status of IMUNON's Phase 3 OVATION 3 Study?
How did IMUNON address its Nasdaq listing compliance issues?
