On September 24, 2026 Celularity Inc. (Nasdaq: CELU) ("Celularity" or the "Company"), a regenerative and cellular medicine company, reported an initial closing generating over $10 million in gross cash proceeds from a private placement of senior secured convertible notes and warrants. The closing is part of a broader recapitalization plan contemplating up to $25 million in new cash investment, including the initial closing, and the restructuring of approximately $3 million in existing indebtedness.

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The financing follows significant operating improvements, including a reduction in monthly cash burn of more than $1 million, personnel optimization and a sharper allocation of resources toward revenue-generating opportunities. With a lower operating cost base, purpose-built manufacturing infrastructure and existing cenplacel-L inventory that management estimates represents approximately $40 million in potential sales value, Celularity is focused on converting its scientific and manufacturing assets into revenue and sustained growth.

The Company also announced the appointment of Philip A. Barach to its Board of Directors, bringing financial expertise and an emphasis on capital allocation, operating accountability and stockholder returns.

"We have built substantial scientific and manufacturing capabilities, and we are taking decisive action to translate those investments into commercial results," said Robert J. Hariri, M.D., Ph.D., Chairman and Chief Executive Officer. "Our lower cost structure, existing cellular product inventory and purpose-built manufacturing facility provide a powerful foundation for growth. This financing supports our ambition to expand revenue-producing relationships, increase utilization of our manufacturing capabilities and pursue opportunities across cellular and regenerative medicine and complementary longevity therapeutics. Our objective is to build a business that can help advance human healthspan while delivering lasting value to stockholders."

"Extending healthy human life is an extraordinary opportunity, and Celularity has spent years building capabilities to help address it," added Peter H. Diamandis, M.D., Co-Founder and Director of Celularity. "The next phase is about translating that foundation into scale by connecting our science with market access, expanding productive partnerships and making our infrastructure an engine of growth. I’m pleased to welcome Philip to the Board and look forward to James joining us as we work to realize that potential."

A Lower Cost Base and a Sharper Focus on Returns

Celularity has implemented substantial budgetary improvements, reduced monthly cash burn by more than $1 million and optimized personnel and spending around its strategic priorities. These actions are designed to make invested capital go further and strengthen the Company’s ability to translate additional revenue into improved operating performance.

Building on these operating improvements and anticipated revenue growth, Celularity expects to achieve positive monthly operating cash flow by the end of the first quarter of 2027. This outlook reflects management’s expectations for increased manufacturing revenue, deployment of existing cellular product inventory and continued control of operating expenses.

"Since my initial investment, Celularity has demonstrated the willingness to make difficult operating decisions and reduce its monthly cash burn, enabling the Company to concentrate resources on bolstering revenue generation," said Philip A. Barach. "That progress was a catalyst for my additional investment and my agreement to join the Board. I see an opportunity to pair a leaner operating structure with substantial scientific and manufacturing assets to build a stronger, more valuable company. My focus will be on directing capital toward the most compelling opportunities and holding the business accountable for measurable results."

Expanding Manufacturing Relationships

The Company’s growth strategy centers on turning its existing scientific and manufacturing assets into revenue-producing partnerships. Its collaboration with MuseCell Innovations Pte. Ltd. ("MCI") illustrates that strategy, establishing U.S. manufacturing capabilities for the Dezawa MuseCell platform and related products at Celularity’s Florham Park facility. The relationship provides an opportunity to increase facility utilization, generate manufacturing revenue and build a foundation for broader commercial expansion. Celularity intends to pursue additional relationships that similarly put its existing infrastructure and expertise to productive use while maintaining a disciplined approach to capital investment.

Approximately $40 Million in Potential Sales From Existing cenplacel-L Inventory

Celularity currently holds inventory of cenplacel-L, its investigational placenta-derived allogeneic cell therapy, that management estimates represents approximately $40 million in potential sales value. The Company intends to pursue deployment through commercial relationships in permissive jurisdictions where supply and use are legally authorized, subject to applicable local regulatory requirements.

This existing inventory provides a tangible foundation for the Company’s domestic and international growth strategy. Celularity aims to convert that inventory into revenue while expanding relationships that can support recurring demand and broader utilization of its manufacturing capabilities.

Transaction Summary

The transaction combines a private placement of senior secured convertible notes and accompanying warrants with the restructuring of existing indebtedness. The initial closing generated over $10 million in gross cash proceeds, before transaction expenses and repayment of existing indebtedness.

The notes mature 24 months after their respective issuance dates and bear interest at 10% per annum, compounded annually. Notes issued at the initial closing are initially convertible into Class A common stock at $1.50 per share. Accompanying five-year warrants are initially exercisable at $1.50 per share and provide eleven warrant shares for every twenty shares initially issuable upon conversion of the notes.

Conversion and exercise prices are subject to adjustment, and issuances remain subject to applicable ownership limitations and Nasdaq stockholder approval requirements. Additional closings are subject to the applicable investor election procedures and other conditions specified in the definitive agreements. The full recapitalization amount includes potential future funding that has not yet been received, and there can be no assurance that additional closings will occur.

In connection with the transaction, Philip A. Barach is to join Robert J. Hariri and Peter H. Diamandis on a newly constituted five-member Board of Directors, with two additional directors to be announced at a later date. The appointments remain subject to applicable requirements, including completion of the Rule 14f-1 information statement process.

Odeon Capital Group LLC acted as placement agent in connection with the initial closing of the private placement.

Further details regarding the financing, restructured indebtedness, Board arrangements and related agreements will be included in a Current Report on Form 8-K.

The securities have not been registered under the Securities Act of 1933, as amended, or applicable state securities laws and may not be offered or sold in the United States absent registration or an applicable exemption. This release does not constitute an offer to sell or a solicitation of an offer to buy securities, nor shall there be any sale in a jurisdiction where such offer, solicitation or sale would be unlawful.

(Press release, Celularity, SEP 24, 2026, View Source;id=409780&p=2454974&I=1206939-c7Z3G6f3m8 [SID1234671056])

On September 24, 2026 Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, reported that an abstract about molecular profiling and tumor biomarker analysis from the Phase 2 RAMP 201 clinical trial of avutometinib plus defactinib in patients with recurrent low-grade serous ovarian cancer (LGSOC) has been selected for a late-breaking oral presentation at the International Gynecologic Cancer Society (IGCS) 2026 Annual Global Meeting, taking place October 1–3, 2026, in Montreal, Canada.

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Additionally, previously reported results from the Phase 2 RAMP 201J study in Japanese patients with recurrent low-grade serous ovarian cancer has also been selected as a seminal oral presentation. Presentation details for all accepted late breaking, seminal, and regular abstracts are listed below and available on the IGCS Annual Global Meeting web site.

Session: Rapid Orals – Rare Gynecologic Tumors Master Session
Title: Molecular Profiling and Tumor Biomarker Analysis of RAMP 201, A Study Demonstrating Efficacy of Avutometinib in Combination with Defactinib in Recurrent Low-Grade Serous Ovarian Cancer
LBA Abstract #: 1016
Presenter: Susana N. Banerjee, MBBS, MA, FRCP, PhD, The Royal Marsden NHS Foundation Trust, London
Date and Time: Friday, October 2, 2026, 10:30 – 11:30​ a.m. ET

Session: Rapid Orals – Rare Gynecologic Tumors Master Session
Title: Avutometinib and Defactinib in Recurrent Low-Grade Serous Ovarian Cancer (LGSOC): A Phase II Study in Japanese Patients (RAMP 201J)
Seminal Abstract #: 1236
Presenter: Shogo Shigeta, M.D., Tohoku University School of Medicine, Tokyo
Date and Time: Friday, October 2, 2026, 10:30 – 11:30​ a.m. ET

Session: Poster Rounds with the Professor
Title: Efficacy of Avutometinib and Defactinib vs Conventional Care in Low-Grade Serous Ovarian Cancer (LGSOC): An External Control Arm Analysis
Abstract and Poster #: 1253/PPD077 (Read the abstract here)
Presenter: Rachel Grisham, M.D., Memorial Sloan Kettering Cancer Center, New York, NY
Date and Time: Friday, October 2, 2026, 2:25 – 2:30 p.m. ET

About RAMP 201
RAMP 201 (ENGOTov60/GOG3052/NCRI) (NCT04625270) was an adaptive, two-part multicenter, parallel cohort, randomized, open-label Phase 2 registration-directed trial evaluating the efficacy and safety of avutometinib alone and in combination with defactinib in patients with recurrent low-grade serous ovarian cancer (LGSOC). The first part of the trial (Part A) determined the selection of the go-forward regimen, which was the combination of avutometinib and defactinib versus avutometinib alone, based on overall response rates. The expansion phases of the trial (Parts B and C) evaluated the safety and efficacy of the go-forward regimen of avutometinib 3.2 mg twice weekly and defactinib 200 mg twice daily. The Part D portion of the trial evaluated a low dose of the combination to inform individualized dose reduction.

About Low-Grade Serous Ovarian Cancer (LGSOC)
LGSOC is a rare ovarian cancer that is insidious and persistent. LGSOC is distinct and different from high-grade serous ovarian cancer (HGSOC) and requires different treatment. LGSOC is highly recurrent and less sensitive to chemotherapy compared to HGSOC. Approximately 6,000-8,000 women in the U.S. and 80,000 worldwide are living with this disease. LGSOC affects younger women with bimodal peaks of diagnosis at ages between 20-30 and 50-60 and has a median survival of approximately ten years. Approximately 70 percent of LGSOC shows RAS pathway-associated mutations, and 30 percent of people with LGSOC have a KRAS mutation. The majority of patients report a negative impact of LGSOC on their mental and physical health, fertility, and long-term quality of life.

About AVMAPKI and FAKZYNJA Combination Therapy
AVMAPKI (avutometinib) inhibits MEK kinase activity while also blocking the compensatory reactivation of MEK by upstream RAF. RAF and MEK proteins are regulators of the RAS/RAF/MEK/ERK (MAPK) pathway. Blocking RAF and/or MEK activates FAK, a key mediator of drug resistance. FAKZYNJA (defactinib) is a FAK inhibitor and together, the avutometinib and defactinib combination was designed to provide a more complete blockade of the signaling that drives the growth and drug resistance of RAS/MAPK pathway-dependent tumors.

The U.S. Food and Drug Administration (FDA) approved AVMAPKI FAKZYNJA CO-PACK (avutometinib capsules; defactinib tablets) for the treatment of adult patients with KRAS-mutated recurrent LGSOC who have received prior systemic therapy on May 8, 2025. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Verastem is conducting RAMP 301 (GOG-3097/ENGOT-ov81/GTG-UK) (NCT06072781), an international Phase 3 confirmatory trial evaluating the combination of avutometinib and defactinib versus standard chemotherapy or hormonal therapy for the treatment of recurrent low-grade serous ovarian cancer (LGSOC) with and without a KRAS mutation. In June 2026, Verastem provided updated results on the Phase 1/2 RAMP 205 trial (NCT05669482), which is evaluating avutometinib plus defactinib in combination with standard-of-care chemotherapy as a first-line treatment for patients with advanced pancreatic cancer. Avutometinib and defactinib are not approved by the FDA or any other regulatory authority, either in combination or with other therapies, for any of these investigative uses. Neither avutometinib nor defactinib are approved by the FDA or any other regulatory authority on a stand-alone basis for any use.

AVMAPKI FAKZYNJA CO-PACK U.S. Indication

Indication

AVMAPKI FAKZYNJA CO-PACK is indicated for the treatment of adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy.

This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Important Safety Information

Warnings and Precautions

Ocular Toxicities: Ocular toxicities, including visual impairment and vitreoretinal disorders, occurred. Perform comprehensive ophthalmic evaluation at baseline, prior to cycle 2, every three cycles thereafter, and as clinically indicated. Withhold AVMAPKI FAKZYNJA CO-PACK for ocular toxicities until improvement at the same or reduced dose. Permanently discontinue AVMAPKI FAKZYNJA CO-PACK for any grade 4 toxicity.
Serious Skin Toxicities: Skin toxicities, including photosensitivity and severe cutaneous adverse reactions (SCARSs) occurred. Adhere to concomitant medications. Monitor for skin toxicities and interrupt, reduce or permanently discontinue AVMAPKI FAKZYNJA CO-PACK based on severity, tolerability and duration.
Hepatotoxicity: Monitor liver function tests prior to each cycle, on day 15 of the first 4 cycles, and as clinically indicated. Withhold, reduce or discontinue AVMAPKI FAKZYNJA CO-PACK based on severity and persistence of abnormality.
Rhabdomyolysis: Monitor creatine phosphokinase prior to the start of each cycle, on day 15 of the first four cycles, and as clinically indicated. If increased CPK occurs, evaluate patients for rhabdomyolysis or other causes. Withhold, reduce or permanently discontinue AVMAPKI FAKZYNJA CO-PACK based on severity and duration of the adverse reaction.
Embryo-Fetal Toxicity: AVMAPKI FAKZYNJA CO-PACK can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception.
Adverse Reactions

The most common (≥ 25%) adverse reactions, including laboratory abnormalities, were increased creatine phosphokinase, nausea, fatigue, increased aspartate aminotransferase, rash, diarrhea, musculoskeletal pain, edema, decreased hemoglobin, increased alanine aminotransferase, vomiting, increased blood bilirubin, increased triglycerides, decreased lymphocyte count, abdominal pain, dyspepsia, dermatitis acneiform, vitreoretinal disorders, increased alkaline phosphatase, stomatitis, pruritus, visual impairment, decreased platelet count, constipation, dry skin, dyspnea, cough, urinary tract infection, and decreased neutrophil count.

Drug Interactions

Strong and moderate CYP3A4 inhibitors: Avoid concomitant use with AVMAPKI FAKZYNJA CO-PACK.
Strong and moderate CYP3A4 inducers: Avoid concomitant use with AVMAPKI FAKZYNJA CO-PACK.
Warfarin: Avoid concomitant use of AVMAPKI FAKZYNJA CO-PACK with warfarin and use an alternative to warfarin.
Gastric acid reducing agents: Avoid concomitant use of AVMAPKI FAKZYNJA CO-PACK with proton pump inhibitors (PPIs) or H2 receptor antagonists. If use of an acid-reducing agent cannot be avoided, administer FAKZYNJA 2 hours before or 2 hours after the administration of a locally acting antacid.
Use in Specific Populations

Lactation: Advise not to breastfeed.
Fertility: May impair fertility in males and females.

(Press release, Verastem, SEP 24, 2026, View Source [SID1234671055])

On September 24, 2026 Elicio Therapeutics, Inc. (Nasdaq: ELTX) ("Elicio" or the "Company"), a clinical-stage biotechnology company developing next-generation immunotherapies for KRAS-driven cancers, reported that new pre-specified analyses from the randomized Phase 2 AMPLIFY-7P study of ELI-002 7P in resected pancreatic ductal adenocarcinoma ("PDAC") have been selected for a late-breaking Proffered Paper oral presentation at the European Society for Medical Oncology ("ESMO") Congress 2026, being held October 23–27, 2026, in Madrid, Spain.

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"We are pleased to share the complete AMPLIFY-7P results, including new late-breaking analyses, with the global oncology community at ESMO (Free ESMO Whitepaper) Congress 2026," said Robert Connelly, President and Chief Executive Officer of Elicio. "These findings deepen our understanding of ELI-002 7P’s clinical and biological activity and provide important direction as we refine the development strategy for a potential Phase 3 study in adjuvant pancreatic cancer."

Proffered Paper Presentation Details

Abstract Number: LBA83
Title: Seven-Valent mKRAS-specific Lymph Node Targeted Amphiphile Immunotherapy Versus Observation in Resected Pancreatic Ductal Adenocarcinoma (PDAC): the AMPLIFY-7P randomized Phase 2 study
Presenter: Eileen M. O’Reilly, M.D., Memorial Sloan Kettering Cancer Center
Date and Time: October 23, 2026, 13:30-15:00 PM, CEST / 7.30-9 AM EST
Location: Almeria Auditorium- Hall 9

The late-breaking abstract will be available via the ESMO (Free ESMO Whitepaper) Congress 2026 website beginning at 00:05 CEST on October 23, 2026, the day of the presentation. Subject to presenter permission, a webcast of the session will be available on ESMO (Free ESMO Whitepaper) Congress 2026 Virtual Platform within 12 hours following the session.

About the AMPLIFY-7P Phase 2 Study

AMPLIFY-7P is a randomized Phase 2 study evaluating ELI-002 7P versus observation in patients with mKRAS-driven PDAC following completion of standard therapy. The study enrolled 144 patients across 24 U.S. clinical sites.

While the study did not meet its pre-specified primary disease-free survival ("DFS") endpoint in the intent-to-treat population, subsequent analyses have provided important insights into the clinical and biological activity of ELI-002 7P and informed the Company’s continued evaluation of the program.

At ESMO (Free ESMO Whitepaper) Congress 2026, Elicio will present new pre-specified analyses from AMPLIFY-7P that provide additional insights into the potential clinical benefit of ELI-002 7P and are expected to further inform the Company’s refined Phase 3 development strategy in adjuvant pancreatic cancer.

About ELI-002

Elicio’s lead product candidate, ELI-002, is a structurally novel investigational Amphiphile ("AMP") cancer immunotherapy that targets cancers driven by mutations in the KRAS gene, a prevalent driver of many human cancers. ELI-002 is comprised of AMP-modified mutant KRAS peptide antigens and ELI-004, an AMP-modified CpG oligodeoxynucleotide adjuvant, and is available as an off-the-shelf subcutaneous administration.

ELI-002 7P, the seven-peptide formulation, was evaluated in the randomized Phase 2 AMPLIFY-7P trial in patients with mKRAS-driven pancreatic cancer. The ELI-002 7P formulation is designed to provide immune response coverage against seven of the most common KRAS mutations present across multiple solid tumors.

(Press release, Elicio Therapeutics, SEP 24, 2026, View Source [SID1234671054])

On September 24, 2026 IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage biotechnology company developing DNA-mediated immunotherapies, reported an update on its IMNN-001 development program for women with newly diagnosed advanced ovarian cancer. The program reviews final overall survival results from the randomized Phase 2 OVATION 2 Study, preliminary clinical and translational findings from the Phase 2 minimal residual disease (MRD) study conducted in partnership with Break Through Cancer and led by investigators at The University of Texas MD Anderson Cancer Center, and enrollment and operational progress in the ongoing pivotal Phase 3 OVATION 3 trial.

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"A 14.7-month median overall survival difference observed in a 112-patient randomized Phase 2 study represents an important clinical signal that we believe warrants confirmation in a pivotal Phase 3 trial," said Stacy R. Lindborg, Ph.D., President and Chief Executive Officer of IMUNON. "For women newly diagnosed with advanced ovarian cancer, it represents the potential for meaningful additional survival at a time when the frontline standard of care has changed very little in more than 25 years."

Dr. Lindborg added, "If confirmed in Phase 3, IMNN-001 has the potential to become the first locally delivered IL-12 immunotherapy for frontline advanced ovarian cancer. In OVATION 2, women who received IMNN-001 plus neoadjuvant and adjuvant chemotherapy achieved a median overall survival of 45.1 months compared with 30.4 months for standard of care alone. Importantly, this survival signal was observed without the historical systemic safety challenges that limited earlier IL-12 programs. While OVATION 2 was not powered for overall survival, confirming that signal in OVATION 3, where overall survival is the primary endpoint, is the work in front of us."

R&D Day Program Highlights

Dr. Lindborg opened the event by framing three questions the Company planned to present answers to: why systemic IL-12 failed historically, why IMNN-001 is different, and why the next stretch of OVATION 3 is the value-defining chapter of the program. Dr. Lindborg also closed the event by describing the Company’s near-term catalysts, including two pre-planned event-driven interim analyses in OVATION 3 designed to create a path to an earlier biologics license application for full approval if the survival signal crosses the pre-specified threshold.

Douglas V. Faller, M.D., Ph.D., Chief Medical Officer, IMUNON, reviewed why recombinant IL-12 programs were abandoned after dose-limiting systemic toxicity, and how IMNN-001 — an IL-12 DNA plasmid formulated with IMUNON’s proprietary TheraPlas nanoparticle and administered intraperitoneally — is designed to produce durable, local IL-12 in the peritoneal cavity where advanced ovarian cancer lives and spreads. Key points presented included:

IMNN-001 is not recombinant IL-12 cytokine injected into the bloodstream. Instead, it instructs the patient’s own cells to produce IL-12 locally, activating both innate and adaptive immunity and remodeling a "cold" tumor microenvironment toward a "hot" antitumor state.
Immune biomarker work from OVATION 1 and OVATION 2 showed increased recruitment of CD8+ T cells, myeloid dendritic cells and M1 macrophages, with decreases in immunosuppressive markers, consistent with the intended mechanism of action.
The OVATION 2 safety profile did not cause the toxicities that closed earlier systemic IL-12 programs: no cytokine release syndrome, no serious systemic immune-related adverse events of the type that historically halted development, and a consistent, manageable profile dominated by gastrointestinal events, including abdominal pain in a minority of patients associated with intraperitoneal administration.
Independent data monitoring committees recommended continuation without modification for both OVATION 3 (mid-2026) and the MRD study (August 2026).

Premal H. Thaker, M.D., David & Lynn Mutch Distinguished Professor, Chief of Gynecologic Oncology and Director of Gynecologic Oncology Clinical Research at Washington University School of Medicine, and study chair of OVATION 2 and OVATION 3, while noting that OVATION 2 was not powered for survival, placed the survival results for OVATION 2 and plans for OVATION 3 in the context of a frontline standard that has been essentially unchanged for more than 25 years. Highlights included:

In the intent-to-treat population of the randomized, 112-patient OVATION 2 study, median overall survival was 45.1 months with IMNN-001 plus neoadjuvant and adjuvant chemotherapy versus 30.4 months with standard of care alone, a 14.7-month difference. The benefit widened as the data matured from the July 2024 readout (11.1 months) to the December 2025 final analysis.
In the PARP inhibitor maintenance subgroup, median overall survival was 65.6 months versus 41.4 months, a 24.2-month improvement.
Primary and secondary endpoints and the safety profile in OVATION 2 favored IMNN-001, with translational evidence of local immune activation at the tumor site.
OVATION 3 is a randomized, 1:1, approximately 500-patient pivotal trial in newly diagnosed Stage IIIB/C or IV epithelial ovarian, fallopian tube or primary peritoneal cancer recommended for neoadjuvant chemotherapy. Overall survival is the primary endpoint. The design includes two pre-planned, event-driven interim analyses intended to support a potential earlier submission for full approval.
Operational progress: protocol submission to site activation in approximately six months; protocol approval to first patient randomized in approximately two months; observed study-level enrollment of about 0.5 patients per site per month versus a 0.3 planning assumption. The Company is targeting completion of enrollment in the first quarter of 2029.

Amir Jazaeri, M.D., Vice Chair for Clinical Research and Director of the Gynecologic Cancer Immunotherapy Program at MD Anderson Cancer Center, and lead principal investigator of the Phase 2 MRD study, presented preliminary clinical and translational findings, noting that while the sample size is still too small to evaluate efficacy, early results appear encouraging. Among patients who have reached second-look laparoscopy to date:

Residual Disease (MRD)-positive rate: 44.4% (4/9) in the IMNN-001 arm versus 66.7% (6/9) in the control arm.
Circulating tumor DNA (ctDNA) clearance: 87.5% (7/8) with IMNN-001 versus 62.5% (5/8) in control.
No evidence of disease after frontline therapy: 9 of 9 evaluable patients (100%) in the experimental arm versus 5 of 9 (56%) in control.
Biomarker data indicates IMNN-001 is preferentially taken up by macrophages in peritoneal fluid and tumor tissue, driving local IL-12 expression, remodeling of the tumor microenvironment, and expanding T-cell receptor clones consistent with induction of anti-cancer immunity. These findings are preliminary and based on patients who have reached the SLL assessment point.

William Bradley, M.D., Professor and Vice Chair for Clinical Research in the Division of Gynecologic Oncology at the Medical College of Wisconsin, and a principal investigator across OVATION 1, 2 and 3, joined an OVATION 1 participant in a prerecorded conversation on what diagnosis, successful treatment with IMNN-001, and the years that followed have meant to her in clinic and at home. The participant, treated with IMNN-001 on the Phase 1b OVATION 1 study, is now almost 10 years from diagnosis and reports remaining free of cancer recurrence.

Webcast
A replay webcast of the event and presentation materials will be available on the "Scientific Presentations" page of the IMUNON website at View Source

About the Phase 3 OVATION 3 Trial
The pivotal Phase 3 OVATION 3 trial is evaluating intraperitoneal IMNN-001 at 100 mg/m² in combination with standard-of-care neoadjuvant and adjuvant chemotherapy versus chemotherapy alone in patients with newly diagnosed Stage IIIB/C or IV epithelial ovarian, fallopian tube or primary peritoneal cancer. The trial is enrolling an all-comers population that includes both homologous recombination-deficient and homologous recombination-proficient patients; eligible patients who respond to first-line platinum-based chemotherapy will proceed to PARP inhibitor maintenance according to applicable guidelines and prescribing information. The primary endpoint is overall survival, with secondary endpoints including chemotherapy response score, surgical response score at interval debulking surgery, time to second-line treatment or death, and objective response rate.

About IMNN-001 Immunotherapy
Designed using IMUNON’s proprietary TheraPlas platform technology, IMNN-001 is an IL-12 DNA plasmid encased in a nanoparticle delivery system that enables cell transfection followed by persistent, local production 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. IMNN-001 has been evaluated as monotherapy and in combination regimens, including the completed Phase 1b OVATION 1 study and the randomized Phase 2 OVATION 2 study of IMNN-001 (100 mg/m² administered intraperitoneally weekly) plus neoadjuvant and adjuvant paclitaxel and carboplatin compared with standard-of-care chemotherapy alone in 112 women with newly diagnosed advanced ovarian cancer. IMNN-001 is now being studied in the pivotal Phase 3 OVATION 3 trial. The program has received Fast Track and Orphan Drug designation in the United States and orphan status in Europe.

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 70% are diagnosed in advanced stage III/IV. Epithelial ovarian cancer is characterized by dissemination of tumors in the peritoneal cavity with a high risk of recurrence (75%, stage III/IV) after surgery and chemotherapy. Since the five-year survival rates of patients with stage III/IV disease at diagnosis are poor (41% and 20%, respectively), there remains a need for a therapy that not only reduces the recurrence rate but also improves overall survival. The peritoneal cavity of advanced ovarian cancer patients contains the primary tumor environment and is an attractive target for a regional approach to immune modulation.

(Press release, IMUNON, SEP 24, 2026, View Source [SID1234671053])

On September 24, 2026 Aptevo Therapeutics Inc. ("Aptevo" or the "Company") (Nasdaq:APVO), a clinical-stage biotechnology company developing novel multispecific immuno-oncology therapeutics based on its proprietary ADAPTIR and ADAPTIR-FLEX platform technologies, reported progress in its next-generation trispecific programs. The Company is optimizing several trispecific candidates for reliable, scalable manufacturing, an essential step toward future human testing. Aptevo expects to enter Investigational New Drug ("IND") enabling studies for the lead candidate, APVO451, in 1H2027.

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Trispecific therapies are gaining attention across cancer drug development as researchers explore their potential to bring multiple complementary functions together in a single molecule. Trispecifics are engineered to do more than traditional antibody therapies. Each molecule can combine three complementary functions to recognize cancer, activate an immune attack and help overcome defenses that cancer uses to survive. Aptevo’s protein-engineering and process development expertise makes it possible to bring these carefully selected functions together in one stable molecule and create differentiated therapies for specific cancers.

"Trispecifics open an exciting new path in cancer drug development by allowing us to engineer several complementary functions into one therapy," said Peter Pavlik, PhD, Senior Director of Protein Engineering at Aptevo. "We are now taking the critical next step – optimizing trispecific candidates for reliable, scalable manufacturing, an essential step toward future human testing. Aptevo expects to enter Investigational New Drug ("IND")-enabling studies for the lead candidate, APVO451, in 1H2027. This progress reflects both the strength of our engineering capabilities and our ability to translate promising science into potential medicines."

The Company’s trispecific programs build on its multispecific expertise, offering the potential to create differentiated candidates – and value – across multiple cancer programs.

Why This Work Builds Value

Aptevo is moving its trispecific candidates beyond molecular design by developing reliable, scalable manufacturing methods to produce them for human testing. Showing that these complex molecules can be manufactured consistently helps reduce a major development risk and prepares the lead candidate for the steps required before human testing. The same expertise and capabilities may also support additional trispecific candidates, strengthening the broader ADAPTIR-FLEX platform and creating more opportunities for future clinical progress and partnerships.

Aptevo expects to present additional details on these ongoing development activities at an upcoming international scientific conference.

(Press release, Aptevo Therapeutics, SEP 24, 2026, View Source [SID1234671052])