IMUNON Recaps Highlights from 2025 Second Quarter Financial Results Conference Call
IMUNON (NASDAQ: IMNN) provided key updates from its Q2 2025 conference call, highlighting significant progress in its Phase 3 OVATION 3 trial for IMNN-001 in advanced ovarian cancer. The company has successfully enrolled and treated its first patient, achieving a rapid launch in just 15 weeks compared to the industry average of 28 weeks.
The company announced a 15% stock dividend for shareholders of record as of August 7, 2025. IMUNON has strengthened its financial position by raising over $3 million through warrant exercises and ATM sales. The company expects to meet Nasdaq's compliance requirements, including the Bid Price requirement, by August 8, 2025.
The Phase 3 trial features a flexible enrollment strategy starting with 250 HRD-positive patients, reducing costs by approximately 40%, with potential expansion to 500 patients. The company maintains efficient in-house manufacturing for IMNN-001, significantly reducing costs compared to outsourcing.
IMUNON (NASDAQ: IMNN) ha fornito aggiornamenti chiave durante la conference call del secondo trimestre 2025, evidenziando progressi significativi nel trial di Fase 3 OVATION 3 per IMNN-001 nel trattamento del cancro ovarico avanzato. L'azienda ha arruolato e trattato con successo il primo paziente, con un lancio rapido in appena 15 settimane rispetto alla media del settore di 28 settimane.
La societ脿 ha annunciato un dividendo azionario del 15% per gli azionisti registrati al 7 agosto 2025. IMUNON ha rafforzato la propria posizione finanziaria raccogliendo oltre 3 milioni di dollari tramite esercizio di warrant e vendite ATM. L'azienda prevede di soddisfare i requisiti di conformit脿 del Nasdaq, incluso il requisito del prezzo di offerta, entro l'8 agosto 2025.
Il trial di Fase 3 prevede una strategia di arruolamento flessibile iniziando con 250 pazienti HRD-positivi, riducendo i costi di circa il 40%, con possibile espansione fino a 500 pazienti. La societ脿 mantiene una produzione interna efficiente per IMNN-001, riducendo significativamente i costi rispetto all'esternalizzazione.
IMUNON (NASDAQ: IMNN) proporcion贸 actualizaciones clave durante su llamada de conferencia del segundo trimestre de 2025, destacando avances significativos en el ensayo de Fase 3 OVATION 3 para IMNN-001 en c谩ncer de ovario avanzado. La compa帽铆a ha inscrito y tratado con 茅xito a su primer paciente, logrando un lanzamiento r谩pido en solo 15 semanas en comparaci贸n con el promedio de la industria de 28 semanas.
La empresa anunci贸 un dividendo en acciones del 15% para los accionistas registrados al 7 de agosto de 2025. IMUNON ha fortalecido su posici贸n financiera recaudando m谩s de 3 millones de d贸lares mediante el ejercicio de warrants y ventas ATM. La compa帽铆a espera cumplir con los requisitos de cumplimiento de Nasdaq, incluido el requisito del precio de oferta, para el 8 de agosto de 2025.
El ensayo de Fase 3 presenta una estrategia de inscripci贸n flexible que comienza con 250 pacientes positivos para HRD, reduciendo costos aproximadamente en un 40%, con la posibilidad de expandirse a 500 pacientes. La empresa mantiene una fabricaci贸n interna eficiente para IMNN-001, reduciendo significativamente los costos en comparaci贸n con la subcontrataci贸n.
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IMUNON (NASDAQ : IMNN) a fourni des mises 脿 jour cl茅s lors de sa conf茅rence t茅l茅phonique du deuxi猫me trimestre 2025, mettant en avant des progr猫s significatifs dans son essai de phase 3 OVATION 3 pour IMNN-001 dans le cancer ovarien avanc茅. La soci茅t茅 a r茅ussi 脿 enr么ler et traiter son premier patient, r茅alisant un lancement rapide en seulement 15 semaines contre une moyenne industrielle de 28 semaines.
La soci茅t茅 a annonc茅 un dividende en actions de 15% pour les actionnaires inscrits au 7 ao没t 2025. IMUNON a renforc茅 sa position financi猫re en levant plus de 3 millions de dollars gr芒ce 脿 l'exercice de bons de souscription et 脿 des ventes ATM. La soci茅t茅 pr茅voit de satisfaire aux exigences de conformit茅 du Nasdaq, y compris le crit猫re du prix d'offre, d'ici le 8 ao没t 2025.
L'essai de phase 3 pr茅sente une strat茅gie d'inclusion flexible d茅butant par 250 patients HRD-positifs, r茅duisant les co没ts d'environ 40%, avec une 茅ventuelle extension 脿 500 patients. La soci茅t茅 maintient une production interne efficace pour IMNN-001, r茅duisant significativement les co没ts par rapport 脿 l'externalisation.
IMUNON (NASDAQ: IMNN) gab wichtige Updates aus dem Conference Call zum zweiten Quartal 2025 bekannt und hob dabei bedeutende Fortschritte in der Phase-3-Studie OVATION 3 f眉r IMNN-001 bei fortgeschrittenem Eierstockkrebs hervor. Das Unternehmen hat den ersten Patienten erfolgreich eingeschlossen und behandelt und damit einen schnellen Start in nur 15 Wochen im Vergleich zum Branchendurchschnitt von 28 Wochen erreicht.
Das Unternehmen k眉ndigte eine 15%ige Aktiendividende f眉r Aktion盲re an, die am 7. August 2025 eingetragen sind. IMUNON hat seine finanzielle Position durch die Einwerbung von 眉ber 3 Millionen US-Dollar durch die Aus眉bung von Warrants und ATM-Verk盲ufe gest盲rkt. Das Unternehmen erwartet, die Nasdaq-Konformit盲tsanforderungen, einschlie脽lich der Gebotspreisanforderung, bis zum 8. August 2025 zu erf眉llen.
Die Phase-3-Studie verf眉gt 眉ber eine flexible Einschreibestrategie, die mit 250 HRD-positiven Patienten beginnt und die Kosten um etwa 40% senkt, mit der M枚glichkeit einer Erweiterung auf 500 Patienten. Das Unternehmen h盲lt eine effiziente Inhouse-Produktion von IMNN-001 aufrecht, was die Kosten im Vergleich zur Auslagerung erheblich senkt.
- First patient enrolled and treated in Phase 3 OVATION 3 trial, with rapid 15-week launch vs. 28-week industry average
- Trial design powered at 95% to detect OS improvement, with 40% cost reduction through flexible enrollment strategy
- Raised over $3 million through warrant exercises and ATM sales
- 15% stock dividend announced to enhance shareholder value without dilution
- In-house manufacturing achieving significant cost reduction compared to outsourcing
- Strong medical community interest following ASCO presentation and journal publication
- Ongoing Nasdaq compliance issues requiring resolution for both Shareholder Equity and Bid Price requirements
- Need for additional funding to fully support OVATION 3 trial
- Implemented cash conservation measures including reductions in expenses and non-core activities
Investors are reminded that Shareholders of record as of August 7, 2025, will receive a
LAWRENCEVILLE, N.J., Aug. 05, 2025 (GLOBE NEWSWIRE) -- , Inc. (Nasdaq: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, earlier 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 and the introduction of a
The following is a summary of remarks by Imunon鈥檚 President and CEO Stacy Lindborg, PhD. on the second quarter 2025 financial results conference call, provided for Shareholders unable to join the call:
- Advancing the Pivotal Phase 3 OVATION 3 Trial for IMNN-001 in Newly Diagnosed Advanced Ovarian Cancer: The Company is well-positioned for efficient and timely execution of this pivotal Phase 3 study, and has enrolled and begun treating its first patient on the protocol, building on the robust Phase 2 OVATION 2 Study data that demonstrated unprecedented overall survival (OS) benefits in IMNN-001-treated women with advanced ovarian cancer. If replicated in the Phase 3 OVATION 3 Study, these results represent the potential for IMNN-001 to transform the standard of care for ovarian cancer, addressing a significant unmet need in frontline treatment, where no OS improvement has been seen in more than 25 years.
- Three trial sites activated to date, with the first patient randomized and treated on July 25, 2025; rapid launch achieved in only 15 weeks (vs. industry average of 28 weeks), reflecting strong investigator enthusiasm and team agility. Additional sites, including many from prior OVATION studies of IMNN-001, are currently being activated, with plans for further expansion to accelerate patient recruitment.
- Trial design includes two interim analyses and is powered at
95% to detect a meaningful OS improvement, the primary endpoint, in the intent-to-treat (ITT) population and99% in the HRD-positive subgroup, with secondary endpoints encompassing surgical and chemotherapy response scores, clinical response, and time to second-line treatment. - Flexible enrollment strategy starts with a 250-patient HRD-positive subgroup, including women with BRCA1/2 mutations, reducing costs by approximately
40% and enabling potentially an early important data readout for this patient population as well as potential expansion to a 500-patient all-comers trial.
- Streamlined Operations and Resource Focus: IMUNON has implemented targeted cash conservation measures, including reductions in monthly rent commitments, G&A expenses, and non-core activities, to align all resources with the regulatory approval and commercial launch of IMNN-001.
- Robust Supply Chain and Cost Efficiency: The Company maintains a highly reliable, in-house manufacturing process for key components of IMNN-001, ensuring supply continuity and achieving an order-of-magnitude cost reduction compared to full outsourcing.
- Strong Medical Community Engagement and Validation: OVATION 2 Study data garnered significant interest, highlighted by an oral presentation at the 2025 ASCO Annual Meeting, simultaneous publication in the peer-reviewed journal Gynecologic Oncology, and new insights of IMNN-001 presented at the ESMO Gynaecological Cancers Congress. These positive data have led to unsolicited inquiries from global principal investigators eager to join the Phase 3 OVATION 3 Study, underscoring IMNN-001's potential as a targeted, immune-engaging therapy.
- Financial Strength and NASDAQ Compliance: IMUNON has bolstered its balance sheet with more than
$3 million following the end second quarter 2025 via warrant exercises and ATM sales, while introducing a one-time15% stock dividend (record date August 7, 2025) to enhance shareholder value and liquidity without dilution or cash outlay. Active pursuit of non-dilutive partnerships for the TheraPlas庐 and PlaCCine庐 platforms, alongside equity strategies, aims to fully fund OVATION 3. The Company has achieved compliance with Nasdaq鈥檚 Shareholder Equity Rule and expects to ensure sustained compliance with such rule in accordance with the Company鈥檚 compliance plan as presented to the Nasdaq Hearings Panel in early July 2025. The Company also anticipates meeting the Bid Price requirement (>$1.00 for 10 consecutive days) as early as August 8, 2025, which the Company expects will cure such deficiency.
鈥淥ur commitment to creating shareholder value, advancing our promising novel immunotherapy, and addressing the urgent unmet needs of women with newly diagnosed advanced ovarian cancer is unwavering,鈥� said Dr. Lindborg. 鈥淲e look forward to providing ongoing updates as IMUNON continues to make meaningful progress in the dynamic field of oncology drug development.鈥�
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 for 90 days.
About the Phase 2 OVATION 2 Study
OVATION 2 evaluated the dosing, safety, efficacy and biological activity of intraperitoneal administration of IMNN-001 in combination with neoadjuvant and adjuvant chemotherapy (N/ACT) of paclitaxel and carboplatin in patients newly diagnosed with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer. Treatment in the neoadjuvant period is designed to shrink the tumors as much as possible for optimal surgical removal after three cycles of chemotherapy. Following N/ACT, patients undergo interval debulking surgery, followed by three additional cycles of adjuvant chemotherapy to treat any residual tumor. This open-label study enrolled 112 patients who were randomized 1:1 and evaluated for safety and efficacy to compare N/ACT plus IMNN-001 versus standard-of-care N/ACT. In accordance with the study protocol, patients randomized to the IMNN-001 treatment arm could receive up to 17 weekly doses of 100 mg/m2 in addition to N/ACT. As a Phase 2 study, OVATION 2 was not powered for statistical significance. Additional endpoints included objective response rate, chemotherapy response score and surgical response score.
About IMNN-001 Immunotherapy
Designed using IMUNON's proprietary TheraPlas庐 platform technology, IMNN-001 is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system that enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anticancer immunity acting through the induction of T-lymphocyte and natural killer cell proliferation. IMUNON previously reported positive safety and encouraging Phase 1 results with IMNN-001 administered as monotherapy or as combination therapy in patients with advanced peritoneally metastasized primary or recurrent ovarian cancer and completed a Phase 1b dose-escalation trial (the OVATION 1 Study) of IMNN-001 in combination with carboplatin and paclitaxel in patients with newly diagnosed ovarian cancer. IMUNON previously reported positive results from the recently completed Phase 2 OVATION 2 Study, which assessed IMNN-001 (100 mg/m2 administered intraperitoneally weekly) plus neoadjuvant and adjuvant chemotherapy (N/ACT) of paclitaxel and carboplatin compared to standard-of-care N/ACT alone in 112 patients with newly diagnosed advanced ovarian cancer.
About Epithelial Ovarian Cancer
Epithelial ovarian cancer is the sixth deadliest malignancy among women in the U.S. There are approximately 20,000 new cases of ovarian cancer every year and approximately
础产辞耻迟听滨惭鲍狈翱狈
IMUNON is a clinical-stage biotechnology company focused on advancing a portfolio of innovative treatments that harness the body鈥檚 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庐, 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庐, is developed for the gene delivery of viral antigens that can elicit a strong immunological response.
The Company鈥檚 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). 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 .
Forward-Looking Statements
IMUNON wishes to inform readers that forward-looking statements in this news release are made pursuant to the 鈥渟afe harbor鈥� 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鈥檚 ability to regain compliance with Nasdaq鈥檚 continued listing requirements, the timing of enrollment of the Company鈥檚 clinical trials, the potential of any therapies developed by the Company to fulfill unmet medical needs, the market potential for the Company鈥檚 products, if approved, the potential efficacy and safety profile of our product candidates, and the Company鈥檚 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 鈥渕ay,鈥� 鈥渨ill,鈥� 鈥渆xpect,鈥� 鈥減lan,鈥� 鈥渁nticipate,鈥� 鈥渆stimate,鈥� 鈥渋ntend鈥� and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances). Readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, 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鈥檚 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 |
| Jenna Urban | Peter Vozzo |
| CG life | ICR Healthcare |
| 212-253-8881 | 443-213-0505 |
| [email protected] | [email protected] |
FAQ
What is the significance of IMUNON's Phase 3 OVATION 3 trial for IMNN-001?
How will IMUNON's 15% stock dividend impact shareholders?
What is IMUNON's current financial position and Nasdaq compliance status?
How is IMUNON managing manufacturing costs for IMNN-001?
What are the key features of IMUNON's Phase 3 OVATION 3 trial design?
