Imunon, Inc.
For the period ended Jun 30, 2025. Filed Aug 5, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2025 · Filed Aug 5, 2025
IMNN$0.84-6.2%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-03-31; filed 2025-05-12.
0001641172-25-009572
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-06-30; filed 2025-08-05.
0001493152-25-011598
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 94 previous paragraphs and 114 current paragraphs.
80 unchanged; 14 reworded; 14 added; 0 removed; 0 previous and 6 current paragraphs rearranged.
Tables are not compared: 11 previous and 12 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (14)
Current report
In June 2025, the Company announced positive data from the Company’s 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 overall survival (OS), progression-free survival (PFS), chemotherapy response score and surgical response. Treatment with IMNN-001 also showed a favorable safety profile, with no reports of serious immune-related adverse events. The full results were presented in an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois, and simultaneously published in the peer-reviewed journal Gynecologic Oncology. The data presented highlighted the consistent results achieved across all treatment groups, demonstrating: Median 13-month increase in OS (46 vs. 33 months) and median 3-month increase in PFS (14.9 vs. 11.9 months) in IMNN-001 treatment arm compared to standard of care alone. 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 poly ADP-ribose polymerase (PARP) inhibitors as part of maintenance therapy further enhanced outcomes, with median OS not yet reached in IMNN-001 treatment arm after >5 years compared to 37 months on standard of care. Chemotherapy response score highlights double the response rate of a complete or near complete histopathological response following treatment with 26.1% in the IMNN-001 treatment arm compared to 13.0% in the control arm. Surgical response rate of no macroscopic residual tumor left after surgery 64.6% in the IMNN-001 treatment arm compared to 52.1% in the control arm. Hazard ratio of 0.78 in study participants who are homologous recombination proficient (HRP) and hazard ratio of 0.42 in women positive for homologous recombination deficiency (HRD+), including BRCA1 or BRCA2 mutations, suggesting increased therapeutic activity. IMNN-001 was generally safe and well tolerated, with no reports of cytokine release syndrome, systemic toxicity or serious immune-related adverse events.
Current report
On June 18, 2025, the Company announced the presentation of new positive translational data from the Phase 2 OVATION 2 Study of IMNN-001 at the ESMO Gynaecological Cancers Congress 2025, that took place on June 19-21, 2025, in Vienna, Austria. Results presented at the ESMO Congress showed that treatment with IMNN-001 induced substantial increases in IL-12 and interferon-gamma (IFN-γ) and tumor necrosis factor-alpha (TNF-α), key downstream anti-cancer immune cytokines. Increases in IL-12, IFN-γ and TNF-α levels in the peritoneal cavity were approximately 27-, 62- and 36-fold following treatment, respectively, demonstrating the tumor-localized effect of IMNN-001 in women with advanced ovarian cancer. IMNN-001 continues to show a favorable safety profile.
Current report
As of June 30, 2025, Providence Sacred Heart Medical Center & Children’s Hospital and Washington University School of Medicine in St. Louis are open to recruitment.
Current report
On May 15, 2025, the Company announced new data from its first Phase 1 proof-of-concept clinical trial of IMNN-101. Results in 24 healthy volunteers demonstrated IMNN-101’s durability of protection at six months after a single dose targeting the SARS-CoV-2 Omicron XBB1.5 spike antigen variant. IMNN-101 induced up to a 3-fold median increase in the serum neutralizing antibody (NAb) titers from baseline at six months, with initial evidence of a stronger immune response in two higher dose cohorts (2.0 mg and 1.0 mg) compared to a lower dose cohort (0.5 mg). The highest observed increase among the participating volunteers was 8-fold from baseline. IMNN-101 continues to be safe and well tolerated, with no serious adverse effects reported.
Current report
In the Phase 1 trial, designed to demonstrate the advantages of Imunon’s technology compared to approved messenger RNA (mRNA) vaccines, IMNN-101 was administered as a single dose vaccine without a booster dose in study participants who were previously vaccinated against the Omicron XBB1.5 variant. Study participants had high baseline immune characteristics, presumably from prior infection and multiple previous vaccinations against COVID-19, and ongoing infection. Modest increases in T-cell responses were observed in trial participants who received multiple immunizations prior to the study. Results from the Phase 1 trial build on data previously announced in February 2025, which showed IMNN-101 induced a persistent 2- to 4-fold increase in serum NAb titers from baseline through Week 4, further increasing NAb titers between Week 2 and Week 4. The immune response was also observed against the XBB1.5 variant and many newer variants following treatment, demonstrating the IMNN-101 vaccine’s cross-reactivity. The Phase 1 clinical data of IMNN-101 is consistent with strong evidence of immunogenicity and protection for the PlaCCine platform in rodents and non-human primates, with prior preclinical results showing comparable protection efficiency (>95%) to a commercial mRNA vaccine in non-human primates.
Current report
On June 17, 2025, the Company announced that an abstract highlighting Phase 1 proof-of-concept clinical trial results of IMNN-101 was accepted for oral presentation at the 10 th International Conference on Vaccines Research & Development. The meeting is being held November 5-7, 2025, in Boston, MA.
Current report
May 2025 Offering
Current report
On May 23, 2025, the Company entered into a Securities Purchase Agreement with certain institutional and accredited investors, for the issuance and sale in a private placement of: (i) 185,186 shares of the Company’s common stock, (ii) 296,297 of pre-funded warrants at an exercise price of $0.0015 per share and (iii) 962,964 warrants at an exercise price of $6.75 per share for gross proceeds of approximately $3.3 million before the deduction of placement agent fees and offering expenses.
Current report
The Prefunded Warrants became exercisable immediately after issuance for a term of two and one-half years following the date of issuance. The Warrants will be exercisable upon receipt of such approval as may be required by the applicable rules and regulations of the Nasdaq Stock Market (or any successor entity) from the stockholders of the Company with respect to issuance of all of the Warrants and the shares of Common Stock upon the exercise thereof (“Stockholder Approval,” and such date, the “Stockholder Approval Date”) and have a term of three years. The prefunded warrants were exercised in full on June 16, 2025 and June 18, 2025.
Current report
In addition, the Company issued to H.C. Wainwright & Co., LLC warrants (the “Placement Agent Warrants”) to purchase up to an aggregate of 24,075 shares of common stock at an exercise price equal to $8.44 per share. The Placement Agent Warrants have substantially the same terms as the Warrants. The closing of the May 2025 Offering occurred on May 28, 2025. On July 11, 2025, the Company’s shareholders approved the issuance of the Warrants.
Current report
General and administrative expenses were $1.5 million in the second quarter of 2025 compared to $2.2 million in the same period of 2024. The decrease was primarily attributable to lower employee-related expenses of $0.7 million.
Current report
Results of Operations
Current report
Research and Development Expenses
Current report
General and Administrative Expenses
Reworded paragraphs (14)
Previous wording
On September 11, 2024, a scientific advisory board was held with DSMB members, principal investigators, and scientific experts to discuss and seek input on the protocol synopsis for the Phase III trial. A protocol synopsis was submitted along with a briefing document for review and input at the End-of-Phase II (“EOP2”) meeting with the U.S. Food and Drug Administration focused on the Phase III study. The EOP2 meeting was conducted in the fourth quarter of 2024.
Current wording
***OVATION 3 Study.***On September 11, 2024, a scientific advisory board was held with DSMB members, principal investigators, and scientific experts to discuss and seek input on the protocol synopsis for the Phase III trial. A protocol synopsis was submitted along with a briefing document for review and input at the End-of-Phase II (“EOP2”) meeting with the U.S. Food and Drug Administration focused on the Phase III study. The EOP2 meeting was conducted in the fourth quarter of 2024.
Previous wording
IMNN-001 in Combination with bevacizumab. In February 2023, the Company and Break Through Cancer, a public foundation dedicated to supporting translational research in the most difficult-to-treat cancers that partners with top cancer research centers, announced the commencement of patient enrollment in a collaboration to evaluate IMNN-001 in combination with bevacizumab in patients with advanced ovarian cancer in the frontline, neoadjuvant clinical setting.
Current wording
IMNN-001 in Combination with bevacizumab. In February 2023, the Company and BreakThroughCancer, a public foundation dedicated to supporting translational research in the most difficult-to-treat cancers that partners with top cancer research centers, announced the commencement of patient enrollment in a collaboration to evaluate IMNN-001 in combination with bevacizumab in patients with advanced ovarian cancer in the frontline, neoadjuvant clinical setting.
Previous wording
As of March 31, 2025, fourteen patients were enrolled and treated in the study at the University of Texas MD Anderson Cancer Center and Memorial Sloan Kettering Cancer Center. John Hopkins Medicine Sidney Kimmel Cancer Care Center has been added as a clinical site for this study and is open to recruitment.
Current wording
As of June 30, 2025, fifteen patients were enrolled and treated in the study at the University of Texas MD Anderson Cancer Center and Memorial Sloan Kettering Cancer Center. John Hopkins Medicine Sidney Kimmel Cancer Care Center is open to recruitment.
Previous wording
As of March 31, 2025, the Company had $2.9 million in cash and cash equivalents to fund its operations. The Company’s primary sources of cash have been proceeds from the issuance and sale of its common stock, including via its at-the-market (“ATM”) program and other potential funding transactions. There can be no assurance that the Company will be able to do so in the future on a timely basis on terms acceptable to the Company, or at all. The Company has not yet commercialized any of its product candidates. Even if the Company commercializes one or more of its product candidates, it may not become profitable in the near term. The Company’s ability to achieve profitability depends on several factors, including its ability to obtain regulatory approval for its product candidates, successfully complete any post-approval regulatory obligations and successfully commercialize its product candidates alone or in partnership.
Current wording
As of June 30, 2025, the Company had $4.7 million in cash and cash equivalents to fund its operations. The Company’s primary sources of cash have been proceeds from the issuance and sale of its common stock, including via its at-the-market (“ATM”) program and other potential funding transactions. There can be no assurance that the Company will be able to do so in the future on a timely basis on terms acceptable to the Company, or at all. The Company has not yet commercialized any of its product candidates. Even if the Company commercializes one or more of its product candidates, it may not become profitable in the near term. The Company’s ability to achieve profitability depends on several factors, including its ability to obtain regulatory approval for its product candidates, successfully complete any post-approval regulatory obligations and successfully commercialize its product candidates alone or in partnership.
Previous wording
During 2025 and 2024 through the date of this Quarterly Report on Form 10-Q, we issued a total of 5.2 million shares of common stock as discussed below for approximately $9.2 million in net proceeds.
Current wording
During 2025 and 2024 through the date of this Quarterly Report on Form 10-Q, we issued a total of 1.1 million shares of common stock as discussed below for approximately $14.0 million in net proceeds.
Previous wording
On May 15, 2024, the Company filed with the SEC a shelf registration statement on Form S-3 (the “2024 Registration Statement”) for the offer and sale of up to $75 million of its securities. The 2024 Registration Statement was declared effective on May 22, 2024. The 2024 Registration Statement is intended to provide the Company with flexibility to raise capital in the future for general corporate purposes. However, the Company’s ability to offer and sell its securities in a primary offering on the 2024 Registration Statement is limited by General Instruction I.B.6 of Form S-3 (the “Baby Shelf Limitation”), which limits the amount that the Company can offer to up to one-third of its public float during any trailing 12-month period. The Company would no longer be subject to the Baby Shelf Limitation if its public float exceeds $75 million. In the first quarter of 2025, the Company sold 120,047 shares of common stock for net proceeds of $105,693. The Company did not sell any shares of common stock under the ATM program in 2024.
Current wording
On May 15, 2024, the Company filed with the SEC a shelf registration statement on Form S-3 (the “2024 Registration Statement”) for the offer and sale of up to $75 million of its securities. The 2024 Registration Statement was declared effective on May 22, 2024. The 2024 Registration Statement is intended to provide the Company with flexibility to raise capital in the future for general corporate purposes. However, the Company’s ability to offer and sell its securities in a primary offering on the 2024 Registration Statement is limited by General Instruction I.B.6 of Form S-3 (the “Baby Shelf Limitation”), which limits the amount that the Company can offer to up to one-third of its public float during any trailing 12-month period. The Company would no longer be subject to the Baby Shelf Limitation if its public float exceeds $75 million. In the first quarter of 2025, the Company sold 8,003 shares of common stock for net proceeds of $105,693. The Company did not sell any shares of common stock under the ATM program in 2024.
Previous wording
For the three months ended March 31, 2025, our net loss was $4.1 million compared to a net loss of $4.9 million for the same three-month period of 2024.
Current wording
For the three months ended June 30, 2025, our net loss was $2.8 million compared to a net loss of $4.8 million for the same three-month period of 2024.
Previous wording
With $2.9 million in cash and cash equivalents, short-term investments and interest receivable at March 31, 2025, such conditions raise substantial doubts about the Company’s ability to continue as a going concern. Based on the above, management has determined there is substantial doubt regarding our ability to continue a going concern.
Current wording
With $4.7 million in cash and cash equivalents at June 30, 2025, such conditions raise substantial doubts about the Company’s ability to continue as a going concern. Based on the above, management has determined there is substantial doubt regarding our ability to continue a going concern.
Previous wording
Research and development (“R&D”) expenses were $2.2 million in the first quarter of 2025 compared to $3.3 million in same period of 2024. Clinical costs associated with the OVATION program were $0.2 million in the first quarter of 2025 compared to $0.3 million in 2024. Clinical costs associated with the PlaCCine vaccine trial were $58,000 in the first quarter of 2025 compared to $0.6 million in the first quarter of 2024. Other clinical and regulatory costs were $0.6 million the first quarter of 2025 compared to $0.5 million in the same period of 2024. R&D costs associated with the development of IMNN-001 to support the OVATION program were $0.9 million in the first quarter of 2025 compared to $0.4 million in same period of 2024. The development of the PLACCINE DNA vaccine technology platform was $1.2 million in the first quarter of 2024. CMC costs were $0.4 million in the first quarter of 2025 compared to $0.3 million in the same period of 2024.
Current wording
Research and development (“R&D”) expenses were $1.2 million in the second quarter of 2025 compared to $2.8 million in same period of 2024. Clinical costs associated with the OVATION program were $0.2 million in the second quarter of 2025 compared to $0.4 million in the same period of 2024. Clinical costs associated with the PlaCCine vaccine trial were $25,000 in the second quarter of 2025 compared to $0.3 million in the second quarter of 2024. Other clinical and regulatory costs were $0.3 million the second quarter of 2025 compared to $0.6 million in the same period of 2024. R&D costs associated with the development of IMNN-001 to support the OVATION program were $0.6 million in the second quarter of 2025 compared to $0.2 million in same period of 2024. The development of the PLACCINE DNA vaccine technology platform was $0.7 million in the second quarter of 2024. CMC costs were $0.1 million in the second quarter of 2025 compared to $0.5 million in the same period of 2024.
Previous wording
Investment income from the Company’s short-term investments was $43,000 for the first quarter of 2025 compared to $82,000 for the same period in 2024.
Current wording
Investment income from the Company’s short-term investments was $27,000 for the second quarter of 2025 compared to $225,000 for the same period in 2024 due to cash balance.
Previous wording
General and administrative expenses were $2.0 million in the first quarter of 2025 compared to $1.7 million in the same period of 2024. The increase was primarily attributable to higher employee-related expenses of $0.5 million offset by lower legal expenses of $0.2 million.
Current wording
General and administrative expenses were $3.5 million in the first half of 2025 compared to $3.9 million in the same period of 2024. The decrease was primarily attributable to lower employee-related expenses of $0.2 million and lower legal expenses and travel costs of $0.2 million.
Previous wording
Since inception, we have incurred significant losses and negative cash flows from operations. We have financed our operations primarily through the net proceeds from the sales of equity, credit facilities and amounts received under product licensing agreements. The process of developing IMNN-001 and other drug candidates and technologies requires significant research and development work and clinical trial studies, as well as significant manufacturing and process development efforts. We expect these activities, together with our general and administrative expenses, to result in significant operating losses for the foreseeable future. Our expenses have significantly and regularly exceeded our income, and we had an accumulated deficit of $411 million at March 31, 2025.
Current wording
Since inception, we have incurred significant losses and negative cash flows from operations. We have financed our operations primarily through the net proceeds from the sales of equity, credit facilities and amounts received under product licensing agreements. The process of developing IMNN-001 and other drug candidates and technologies requires significant research and development work and clinical trial studies, as well as significant manufacturing and process development efforts. We expect these activities, together with our general and administrative expenses, to result in significant operating losses for the foreseeable future. Our expenses have significantly and regularly exceeded our income, and we had an accumulated deficit of $414 million at June 30, 2025.
Previous wording
At March 31, 2025, we had total current assets of $5.1 million and current liabilities of $5.8 million, resulting in a negative net working capital of $0.7 million. At March 31, 2025, we had cash and cash equivalents of $2.9 million. At December 31, 2024, we had total current assets of $8.0 million and current liabilities of $4.8 million, resulting in net working capital of $3.2 million. We have substantial future capital requirements to continue our research and development activities and advance our drug candidates through various development stages. The Company believes these expenditures are essential for the commercialization of its technologies.
Current wording
At June 30, 2025, we had total current assets of $6.9 million and current liabilities of $5.3 million, resulting in a net working capital of $1.6 million. At June 30, 2025, we had cash and cash equivalents of $4.7 million. At December 31, 2024, we had total current assets of $8.0 million and current liabilities of $4.8 million, resulting in net working capital of $3.2 million. We have substantial future capital requirements to continue our research and development activities and advance our drug candidates through various development stages. The Company believes these expenditures are essential for the commercialization of its technologies.
Previous wording
Net cash used in operating activities for the first three months of 2025 was $2.8 million. Net cash used by investing activities was $0.3 million during the first three months of 2025.
Current wording
Net cash used in operating activities for the first six months of 2025 was $5.8 million. Net cash used by investing activities was $0.3 million during the first six months of 2025.
Rearranged current paragraphs (6)
Current report — wording carried from elsewhere
FINANCIAL REVIEW FOR THE SIX MONTHS ENDED JUNE 30, 2025 AND 2024
Current report — wording carried from elsewhere
For the six months ended June 30, 2025, our net loss was $6.9 million compared to a net loss of $9.7 million for the same six-month period of 2024.
Current report — wording carried from elsewhere
With $4.7 million in cash and cash equivalents at June 30, 2025, such conditions raise substantial doubts about the Company’s ability to continue as a going concern. Based on the above, management has determined there is substantial doubt regarding our ability to continue a going concern.
Current report — wording carried from elsewhere
Management’s plan includes raising funds from the issuance and sale of its common stock via its ATM program and other funding transactions. However, as mentioned above, there is no assurance such funding will be available to the Company or that it will be obtained on terms favorable to the Company or will provide the Company with sufficient funds to meet its objectives. The Company’s financial statements do not include any adjustments relating to the recoverability and classification of assets, carrying amounts or the amount and classification of liabilities that may be required should the Company be unable to continue as a going concern.
Current report — wording carried from elsewhere
Research and development (“R&D”) expenses were $3.4 million in the first half of 2025 compared to $6.1 million in same period of 2024. Clinical costs associated with the OVATION program were $0.4 million in the first half of 2025 compared to $0.7 million in 2024. Clinical costs associated with the PlaCCine vaccine trial were $83,000 in the first half of 2025 compared to $0.9 million in the first half of 2024. Other clinical and regulatory costs were $0.9 million the first half of 2025 compared to $1.1 million in the same period of 2024. R&D costs associated with the development of IMNN-001 to support the OVATION program were $1.5 million in the first half of 2025 compared to $0.7 million in same period of 2024. The development of the PLACCINE DNA vaccine technology platform was $2.0 million in the first half of 2024. CMC costs were $0.5 million in the first half of 2025 compared to $0.8 million in the same period of 2024.
Current report — wording carried from elsewhere
Investment income from the Company’s short-term investments was $70,000 for the first half of 2025 compared to $307,000 for the same period in 2024 due to cash balance.