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IMUNON Reports First Quarter 2026 Financial Results and Provides Business Update

(Positive)
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IMUNON (NASDAQ: IMNN) reported first quarter 2026 net loss of $4.3 million, or $0.84 per share, with operating expenses of $4.3 million and cash and equivalents of $4.8 million.

Phase 2 OVATION 2 data for IMNN-001 showed median overall survival gains up to 24.2 months and a favorable safety profile, supporting the ongoing Phase 3 OVATION 3 trial, which has FDA-aligned protocol and a defined path to BLA filing.

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Positive

  • Phase 2 OVATION 2: median overall survival 45.1 vs. 30.4 months
  • PARP maintenance subgroup: median OS 65.6 vs. 41.4 months with IMNN-001
  • FDA aligned on Phase 3 OVATION 3 protocol and BLA path
  • OVATION 3 Phase 3 enrollment progressing ahead of plan
  • Strategic reorganization aimed at reducing operating expenses
  • Cash and cash equivalents of $4.8 million at March 31, 2026

Negative

  • Net loss of $4.3 million in Q1 2026 vs. $4.1 million in 2025
  • Operating expenses rose to $4.3 million from $4.1 million year over year
  • Net cash used in operations increased to $4.0 million from $2.8 million

News Market Reaction – IMNN

-1.10%
5 alerts
-1.10% Session close to close
$10.16M Market Cap
1.1x Rel. Volume

In the May 12 session, IMNN declined 1.10%, reflecting a mild negative market reaction. Our momentum scanner triggered 5 alerts that day, indicating moderate trading interest and price volatility.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement combines Q1 2026 financials with strengthened Phase 2 OVATION 2 survival data and ...
Analysis

This announcement combines Q1 2026 financials with strengthened Phase 2 OVATION 2 survival data and confirmation of the Phase 3 OVATION 3 path. Key metrics include a net loss of $4.3M, operating expenses of $4.3M, operating cash use of $4.0M, and cash of $4.8M. Historically, earnings releases have paired similar IMNN-001 progress with mixed stock reactions. Investors may watch future cash updates, OVATION 3 enrollment milestones, and any regulatory interactions for additional clarity.

Key Figures

Phase 2 sample size: 112 women OS benefit (final): 14.7-month increase (45.1 vs. 30.4 months) OS benefit with PARP: 24.2-month increase (65.6 vs. 41.4 months) +5 more
8 metrics
Phase 2 sample size 112 women OVATION 2 trial in newly diagnosed advanced ovarian cancer
OS benefit (final) 14.7-month increase (45.1 vs. 30.4 months) IMNN-001 arm vs. standard of care in OVATION 2
OS benefit with PARP 24.2-month increase (65.6 vs. 41.4 months) IMNN-001 + SoC + PARP maintenance vs. SoC alone
Q1 2026 net loss $4.3 million ($0.84 per share) Three months ended March 31, 2026
Q1 2025 net loss $4.1 million ($3.15 per share) Three months ended March 31, 2025
Q1 2026 operating expenses $4.3 million First quarter 2026
Net cash used in operations $4.0 million First quarter 2026 operating activities
Cash and equivalents $4.8 million As of March 31, 2026

Previous Earnings Reports

5 past events · Latest: Nov 13 (Positive)
Same Type Pattern 5 events
Date Event Sentiment 24h Move Catalyst
Nov 13 Quarterly earnings update Positive +5.3% Q3 2025 results with improved OS data and reduced operating expenses.
Aug 05 Quarterly earnings update Positive -4.8% Q2 2025 results plus stock dividend, trial progress, and new financing.
May 12 Quarterly earnings update Positive +2.0% Q1 2025 results with OVATION 3 initiation and ASCO data acceptance.
Nov 07 Quarterly earnings update Positive -12.3% Q3 2024 results and compelling topline OVATION 2 survival benefit.
Aug 14 Quarterly earnings update Positive -11.4% Q2 2024 results with positive OVATION 2 topline and extended cash runway.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Earnings and business updates have often been clinically positive but followed by weak or negative next-day price moves.

Recent Company History

Over recent quarters, IMUNON has repeatedly paired financial updates with progress on IMNN-001 in advanced ovarian cancer. Prior earnings releases in 2024–2025 highlighted improving overall survival data from OVATION 2, advancing into the pivotal OVATION 3 Phase 3 trial, expense reductions, and selective financings. Despite these clinically favorable signals, several earnings days saw negative price reactions. Today’s Q1 2026 results continue that pattern of modest operating spend and strong survival data, framed around the same OVATION 2 and OVATION 3 programs.

Key Terms

overall survival, standard of care, neoadjuvant, adjuvant, +4 more
8 terms
overall survival medical
"Phase 2 data showing significant overall survival improvement"
Overall survival is the average or median length of time patients remain alive after starting a treatment or entering a clinical study, measured regardless of cause of death. Investors care because it is a clear, hard measure of a therapy’s real-world benefit — like timing how long a new battery actually runs — and strong improvements in overall survival can drive regulatory approval, market adoption and revenue potential.
standard of care medical
"in combination with standard of care (SoC) neoadjuvant and adjuvant chemotherapy"
Standard of care is the accepted medical treatment or clinical approach that most qualified doctors would use for a given condition today, based on available evidence, guidelines and common practice. For investors, it acts like the baseline product customers expect: a new therapy or device must match or improve on the standard of care to win market share, gain reimbursement and limit legal or regulatory risk.
neoadjuvant medical
"standard of care (SoC) neoadjuvant and adjuvant chemotherapy (N/ACT)"
"Neoadjuvant" describes treatments or interventions that are given before the main or primary procedure, such as surgery or a major decision. It’s like preparing the ground before planting seeds, aiming to improve the final outcome. For investors, understanding neoadjuvant approaches can provide insight into how companies enhance results or effectiveness in their processes or products.
adjuvant medical
"standard of care (SoC) neoadjuvant and adjuvant chemotherapy (N/ACT)"
An adjuvant is an ingredient added to a vaccine or other therapy to strengthen or shape the body’s response to the main active component, like a helper that makes the primary ingredient work better or longer. For investors, adjuvants matter because they can change how well a product performs, alter dosing and safety profiles, affect regulatory review, and therefore influence clinical success, market size and competitive advantage.
poly ADP-ribose polymerase (PARP) inhibitors medical
"SoC chemotherapy plus poly ADP-ribose polymerase (PARP) inhibitors as part of maintenance"
Drugs that block PARP, an enzyme cells use to repair damaged DNA, causing cancer cells—especially those already bad at repair—to accumulate lethal damage and die. Think of PARP inhibitors as cutting off a repair crew so weakened structures collapse; they matter to investors because regulatory approvals, clinical trial results, patent protection and competition determine a drug’s market size, pricing power and revenue prospects in oncology.
maintenance therapy medical
"PARP inhibitors as part of maintenance therapy achieved a median increase"
Treatment given after an initial successful response to control a chronic or recurring disease and prevent it from returning or worsening; it often involves lower-intensity, ongoing medication or interventions rather than aggressive cures. For investors, maintenance therapy matters because it can create steady, long-term demand for drugs or services, similar to a subscription that generates predictable revenue and extends a product’s commercial life beyond the initial treatment period.
IL-12 immunotherapy medical
"the potential of this IL-12 immunotherapy to represent a landmark advance"
IL-12 immunotherapy uses a naturally occurring immune-signaling protein called interleukin‑12 to boost the body’s ability to find and destroy diseased cells, most often cancer cells. Think of it as giving the immune system a louder megaphone and a clearer map to recognize threats; for investors, its importance lies in clinical trial results, safety profile and regulatory approval, which determine potential market size and risk.
BLA filing regulatory
"FDA has reviewed and is aligned with Phase 3 protocol, confirms path to BLA Filing"
A BLA filing is a formal application to the U.S. Food and Drug Administration requesting permission to market a biological product, such as a vaccine or therapeutic made from living cells. It contains the company’s complete data on safety, effectiveness and manufacturing quality. For investors, a BLA filing is a major regulatory milestone: approval clears the way to sell the product and generate revenue, while delays or rejection can sharply affect a company’s prospects — think of it like applying for a commercial license to operate a new, tightly regulated business.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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IMNN-001 is the First and Only frontline treatment candidate to demonstrate the potential for a clinically meaningful overall survival benefit in women newly diagnosed with ovarian cancer

Enrollment in the Phase 3 OVATION 3 Study of IMNN-001 is expected to be completed by Q1 2029, supported by remarkable Phase 2 data showing significant overall survival improvement

FDA has reviewed and is aligned with Phase 3 protocol, confirms path to BLA Filing

Company to hold conference call today at 11:00 a.m. ET

LAWRENCEVILLE, N.J., May 12, 2026 (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 months ended March 31, 2026, 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.

“Enrollment in our pivotal Phase 3 OVATION 3 trial continues ahead of plan, reflecting patient interest and strong conviction among principal investigators and the broader medical community in IMNN-001’s therapeutic potential,” said Stacy Lindborg, Ph.D., President and Chief Executive Officer of IMUNON. “Coupled with the unprecedented overall survival benefit observed in our Phase 2 (OVATION 2) study and an aligned path to BLA filing, IMNN-001 is well positioned to potentially transform the standard of care in advanced ovarian cancer.”

RECENT DEVELOPMENTS

Final Phase 2 OVATION 2 Study Data Show Continued Overall Survival Improvement with IMNN-001 in Women with Newly Diagnosed Advanced Ovarian Cancer – On March 25, 2026, the Company announced final data from the completed Phase 2 OVATION 2 clinical trial evaluating IMNN-001 in combination with standard of care (SoC) neoadjuvant and adjuvant chemotherapy (N/ACT) in 112 women with newly diagnosed advanced ovarian cancer. IMUNON previously reported a median 11.1-month increase in overall survival (40.5 vs. 29.4 months) in the IMNN-001 treatment arm compared to SoC chemotherapy alone. Following the most recent and final data assessment, the Company reported a median 14.7-month increase in overall survival (45.1 vs. 30.4 months) in women in the IMNN-001 treatment arm compared to SoC alone, demonstrating continuous improvement in overall survival (3.6 months delta). In addition, the new IMNN-001 data showed that women treated with IMNN-001 and SoC chemotherapy plus poly ADP-ribose polymerase (PARP) inhibitors as part of maintenance therapy achieved a median increase in overall survival of 24.2 months (65.6 vs. 41.4 months) compared to SoC chemotherapy alone. Importantly, with these new efficacy results, IMNN-001 continues to show a highly favorable safety and tolerability profile across all clinical trials, further reinforcing the potential of this IL-12 immunotherapy to represent a landmark advance in treatment of this disease.

IMUNON Sharpens Focus on its Promising Pivotal Phase 3 Ovarian Cancer Study – On February 5, 2026, the Company announced a strategic reorganization, the goal of which was to reduce operating expenses while supporting the Company’s focused strategy to rapidly advance the pivotal Phase 3 OVATION 3 clinical trial.

FIRST QUARTER 2026 FINANCIAL RESULTS

Net loss for the first quarter of 2026 was $4.3 million, or $0.84 per share, compared with a net loss of $4.1 million, or $3.15 per share, for the first quarter of 2025. Operating expenses were $4.3 million for the first quarter of 2026, compared to $4.1 million for the first quarter of 2025.

Research and development expenses increased to $2.3 million in the first quarter of 2026 from $2.2 million in the same period of 2025. During 2025, the Company initiated enrollment in the OVATION 3 Study and in 2026 closed out the OVATION 2 Study.

General and administrative expenses remained unchanged at $2.0 million in each of the first quarters of 2026 and 2025.

Net cash used for operating activities was $4.0 million for the first quarter of 2026, compared with $2.8 million for the same period last year. This increase was primarily due to trial-related expenses associated with the OVATION 3 trial.

As of March 31, 2026, cash and cash equivalents were $4.8 million.

Conference Call and Webcast

The Company will be hosting a conference call to review first quarter 2026 financial results and provide a business update today, May 12, 2026, at 11:00 a.m. EDT. To participate in the call, please dial 800-715-9871 (U.S. and Canada/Toll Free) or 646-307-1963 (U.S./Toll) and ask for the IMUNON First Quarter 2026 Financial Results Call (Conference ID 8083343). A live webcast of the call will also be available here.

An audio replay of the call will be available for 90 days and can be accessed at 800-770-2030 (U.S. and Canada/Toll Free), 609-800-9909 (U.S./Toll) or 647-362-9199 (Canada/Toll) using replay access code 8083343#.

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) and is currently conducting a Phase 3 clinical trial (OVATION 3). The first patient was dosed in the Company’s Phase 3 pivotal study 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 expected reduction of operating expenses related to the strategic reorganization, 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 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: 

MediaInvestors
CG LifeICR Healthcare
Jenna UrbanPeter Vozzo
212-253-8881443-213-0505
jurban@cglife.competer.vozzo@icrhealthcare.com
  

(Tables to Follow)

IMUNON, Inc.
Condensed Consolidated Statements of Operations
(in thousands except per share amounts)

  Three Months Ended March 31, 
  2026  2025 
       
Operating expenses:        
Research and development $2,337  $2,165 
General and administrative  1,970   1,980 
Total operating expenses  4,307   4,145 
         
Loss from operations  (4,307)  (4,145)
         
Other income (expense):        
Investment and other income  58   43 
         
Net loss $(4,249) $(4,102)
         
Net loss per common share        
 Basic and diluted $(0.84) $(3.15)
         
Weighted average shares outstanding        
 Basic and diluted  5,029   1.301 
         


IMUNON, Inc.
Selected Balance Sheet Information
(in thousands)
       
  March 31,
2026
  December 31,
2025
 
ASSETS      
Current assets        
Cash and cash equivalents $4,794  $8,781 
Advances, deposits on clinical programs and other current assets  1,827   1,943 
Total current assets  6,621   10,724 
         
 Property and equipment  460   530 
         
 Other assets        
 Operating lease right-of-use assets  888   984 
 Deposits and other assets  50   50 
Total other assets  938   1,034 
Total assets $8,019  $12,288 
LIABILITIES AND STOCKHOLDERS' EQUITY        
Current liabilities        
Accounts payable and accrued liabilities $3,747  $4,218 
Operating lease liability – current portion  419   406 
Total current liabilities  4,166   4,624 
         
Operating lease liability – noncurrent portion  493   602 
 Total liabilities  4,659   5,226 
Stockholders' equity        
Common stock  39   34 
 Additional paid-in capital  428,953   428,411 
Accumulated deficit  (425,547)  (421,298)
   3,445   7,147 
Less: Treasury stock  (85)  (85)
 Total stockholders' equity  3,360   7,062 
Total liabilities and stockholders' equity  $8,019  $12,288 

# # #


FAQ

What were IMUNON (NASDAQ: IMNN) first quarter 2026 financial results?

IMUNON reported a Q1 2026 net loss of $4.3 million, or $0.84 per share. According to IMUNON, operating expenses were $4.3 million, research and development spending was $2.3 million, and cash and cash equivalents totaled $4.8 million as of March 31, 2026.

How did IMUNON's IMNN-001 perform in the Phase 2 OVATION 2 ovarian cancer study?

IMNN-001 showed a median overall survival of 45.1 months versus 30.4 months with standard chemotherapy alone. According to IMUNON, this represents a 14.7‑month median survival increase and maintained a highly favorable safety and tolerability profile across clinical trials in newly diagnosed advanced ovarian cancer.

What were the OVATION 2 survival results for IMNN-001 with PARP inhibitor maintenance?

Patients receiving IMNN-001 plus standard chemotherapy and PARP inhibitors had median overall survival of 65.6 months versus 41.4 months with chemotherapy alone. According to IMUNON, this 24.2‑month median improvement further supports IMNN-001’s potential in frontline advanced ovarian cancer treatment regimens.

What is the status and timeline of IMUNON's Phase 3 OVATION 3 trial of IMNN-001?

The pivotal Phase 3 OVATION 3 trial is enrolling ahead of plan, with enrollment completion expected by Q1 2029. According to IMUNON, the FDA has reviewed and aligned on the Phase 3 protocol, confirming a path toward a future BLA filing for IMNN-001.

How is the FDA involved in IMUNON's development of IMNN-001 for ovarian cancer?

The FDA has reviewed and is aligned with the Phase 3 OVATION 3 protocol for IMNN-001. According to IMUNON, this alignment confirms a regulatory path to a future Biologics License Application (BLA) filing in newly diagnosed advanced ovarian cancer.

What strategic steps is IMUNON taking to support IMNN-001's Phase 3 OVATION 3 study?

IMUNON implemented a strategic reorganization to reduce operating expenses while focusing resources on the OVATION 3 trial. According to IMUNON, this shift supports rapid advancement of the pivotal Phase 3 study evaluating IMNN-001 in women with newly diagnosed advanced ovarian cancer.

How did IMUNON's operating cash flow change in first quarter 2026?

Net cash used in operating activities rose to $4.0 million in Q1 2026 from $2.8 million a year earlier. According to IMUNON, this increase primarily reflected trial-related expenses associated with the ongoing Phase 3 OVATION 3 clinical study of IMNN-001.