On November 13, 2025 IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, reported financial results for the three-month and nine-month periods ended September 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.

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"IMUNON is rapidly advancing a potential breakthrough for women with newly diagnosed advanced ovarian cancer—a disease with no meaningful frontline treatment progress in decades," said Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON. "Strong Phase 2 OVATION 2 survival data, reinforced by compelling interim results from our MRD study and a clear regulatory path in Phase 3, position IMNN-001 to deliver transformative impact."

"Our clinical success has attracted increasing interest from the medical community and potential partners. As we advance the Phase 3 OVATION 3 Study, which is evaluating IMNN-001 in women with stage IIIC or IV ovarian cancer, we are committed to funding this pivotal trial strategically. We have taken steps to conserve cash and align our critical needs with available capital on hand, while securing the resources needed to advance this potentially transformative therapy with select financing opportunities," Dr. Lindborg continued.

RECENT DEVELOPMENTS

IMNN-001 Immunotherapy

R&D Day Highlighting Progress on OVATION 3 Study in Pursuit of First Frontline Immunotherapy for Advanced Ovarian Cancer – On November 10, 2025, the Company hosted an R&D Day, providing updates on new IMNN-001 data and discussing progress with the OVATION 3 Study and IMNN-001’s potential role in transforming the treatment landscape for women with advanced ovarian cancer. The event featured ovarian cancer thought leaders, principal investigators from the Company’s Phase 3 OVATION 3 Study and Phase 2 minimal residual disease (MRD) clinical trial (conducted in partnership with Break Through Cancer Foundation), and statistical experts.

R&D Day Featured Speakers and Program Highlights:

Premal H. Thaker, M.D., Washington University School of Medicine, discussed the significant continuing unmet needs in ovarian cancer, a devastating disease where patient outcomes and frontline standard of care treatment have not changed for about 30 years, and the promise IMNN-001 brings to these patients and clinicians. She also highlighted the data from the Phase 2 OVATION 2 clinical trial, with results including:
Broad impact observed with IMNN-001 treatment on important cancer-fighting cytokines, effectively turning the tumor microenvironment from "cold" to "hot" by activating both innate and adaptive immune systems, renewing the elusive promise of an immunotherapy for ovarian cancer.
Data reinforcing the highly favorable benefit-risk and safety profile of IMMN 001.
The remarkable median 13-month overall survival (OS) benefit observed with IMNN-001 plus standard of care (SoC) chemotherapy, an increase that is considered clinically meaningful compared to SoC alone.
Amir Jazaeri, M.D., University of Texas MD Anderson Cancer Center, discussed safety, tolerability and translational insights from the Phase 2 MRD study of IMNN-001, including:
Rationale for the trial and the importance of frontline therapy as the best opportunity to achieve a cure for ovarian cancer.
New translational data that shows IMNN-001 preferentially being taken up by macrophages within the peritoneal fluid and tumor tissue, which then induces a robust response and tumor microenvironment remodeling.
New data supporting the highly favorable benefit-risk and tolerability profile of IMNN-001.
The positive tolerability profile of IMNN-001, including in combination with SoC chemotherapy plus bevacizumab, and in the maintenance setting.

Giorgio Paulon, Ph.D., Berry Consultants, LLC, reviewed the Phase 2 and ongoing Phase 3 trial designs, and the strength of evidence for IMNN-001 from a statistical perspective. He highlighted the well-precedented nature of the Phase 3 design with the FDA, which leverages an innovative, adaptive, event-driven approach aligned with prior successful oncology trials that resulted in full approval by FDA based on an interim analysis of overall survival. This foundation, supported by conservative power assumptions drawn from Phase 2 data, strong simulation modeling and robust statistical properties, underpins the Phase 3 trial’s high probability for success.

Douglas V. Faller, M.D., Ph.D., IMUNON, shared new data further demonstrating IMNN-001 shifted the balance in favor of immune stimulation, remodeling the tumor microenvironment in favor of anti-tumor responses, which is established to be associated with better prognosis. He shared the rapid progress to-date on the Phase 3 trial of IMNN-001, including expansion to additional sites and enrollment exceeding the Company’s expectations, strong levels of support and interest from investigators and the scientific community, and key clinical and other milestones for the company moving forward.
The presentations from the R&D Day are available on the "Scientific Presentations" page of the IMUNON’s website at View Source

IMUNON Presents Translational Data from Phase 2 OVATION 2 Study of IMNN-001 at SITC (Free SITC Whitepaper) 40th Annual Meeting – On November 7, 2025, the Company presented translational data from the Phase 2 OVATION 2 clinical trial of IMNN-001 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 40th Annual Meeting, held on November 5-9, 2025 in National Harbor, Maryland.

The new data from recently analyzed OVATION 2 samples demonstrated that IMNN-001 creates a "hot" anti-tumor microenvironment in epithelial ovarian cancer by (i) increasing the recruitment of anti-tumor CD8+, myeloid dendritic cells and M1 macrophages in patient tumors; and (ii) decreasing immunosuppressive markers (IDO, Treg, exhausted CD8, M2 macrophages). These results, including induction of favorable ratios of CD8+/Tregs and CD8+/CD4+ cells, which are both associated with improved patient outcomes, are consistent with the results of the previous OVATION 1 study and with the efficacy seen in the clinic in the OVATION 2 study. This biomarker research confirms local immune activation at the tumor site by IMNN-001.

The poster presentation is available on the "Scientific Presentations" page of the IMUNON’s website at View Source

IMUNON Presents Phase 3 OVATION 3 Study of IMNN-001 in Advanced Ovarian Cancer at the ESMO (Free ESMO Whitepaper) Congress and the IGCS 2025 Annual Global Meeting – On October 14, 2025, the Company announced that a trials-in-progress abstract on the ongoing Phase 3 OVATION 3 clinical trial of IMNN-001 was presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, held on October 17-21, 2025 in Berlin, Germany with an encore presentation following the 2025 Annual Global Meeting of the International Gynecologic Cancer Society (IGCS), held on November 5-7, 2025, in Cape Town, South Africa. The poster presentations are available on the "Scientific Presentations" page of the IMUNON’s website at View Source

Positive Translational Data of IMNN-001 Presented at AACR (Free AACR Whitepaper) Special Conference in Cancer Research Demonstrating 13 Month OS Extension via Tumor Micro-Environment Shift – On September 22, 2025, the Company presented positive translational data from the Phase 2 OVATION 2 Study of IMNN-001 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference in Cancer Research: Advances in Ovarian Cancer Research, held on September 19-21, 2025, in Denver, Colorado reinforcing the favorable safety profile and efficacy benefits of IMNN-001 observed in the clinic, including increases in key anti-cancer immune cytokines and modulation of relevant anti-tumor immune cell populations, such as CD8+ T cells and myeloid dendritic cells, in the tumor and tumor microenvironment in study participants post-treatment.

IMUNON reviewed translational data on the changes induced by the local administration of IL-12 and its downstream effectors in the tumor micro-environment (TME) from paired samples (pre- and post-treatment) from study participants. Results presented at the AACR (Free AACR Whitepaper) Special Conference demonstrated:

Positive shift in the local TME to favorable immune stimulatory T cell ratios in the majority of participants treated with IMNN-001, including favorable ratios of CD8+/T regulatory (Treg) cells, CD8+/IDO+ cells, and CD8+/CD4+ cells.
TME shift in favor of decreased immunosuppression cells (IDO+, PDL1+, Treg, CD4+) and increased immunostimulatory cells (CD8+, CD8+ effector, myeloid dendritic cells) in the majority of participants post-treatment.
IMNN-001 treatment creates a "hot" anti-TME by increasing the recruitment of anti-tumor CD8+ and myeloid dendritic cells in 50-80% of the paired samples and decreasing immunosuppressive markers (IDO, PDL1, Treg cells) in 65-80% of the samples.
Results from the study continue to validate our TheraPlas technology and the broad impact of IMNN-001 on important cancer-fighting cytokines, effectively turning the tumor microenvironment from "cold" to ‘hot’ by activating both innate and adaptive immune systems, with limited to no systemic toxicities. IMNN-001 has shown significant therapeutic potential in clinical trials thus far, and the robust survival benefits and favorable safety profile observed align with these translational findings, supporting the ongoing Phase 3 OVATION 3 trial.

The OVATION 2 Study poster presentation is available on the "Scientific Presentations" page of IMUNON’s website at View Source.

PlaCCine DNA Vaccine Technology

PlaCCine DNA Technology Proof-of-Concept Data Presented in Platform Presentations at Leading Vaccine Conferences – On October 17, 2025, the Company announced that members of its leadership team will deliver oral presentations highlighting IMNN-101, its investigational DNA plasmid vaccine based on the Company’s proprietary PlaCCine technology platform, including proof-of-concept clinical trial results at the following vaccine conferences:

5th Edition of International Vaccines Congress (IVC) Keynote Oral Presentation Title: A promising novel approach to DNA vaccines, on October 23 2025 and
10th International Conference on Vaccine Research and Development Oral Presentation Title: Development of a PlaCCine DNA Technology for Safe, Effective and Durable Vaccines, on November 6, 2025
These presentations described the unique design and composition of the PlaCCine technology and its differentiating features including a longer duration of antigen expression, safety, user compliance and storage stability at workable temperatures (up to one year at 4°C and one month at 37°C) in comparison to mRNA vaccines and other DNA vaccines requiring viruses or devices for delivery. The immunogenicity of the PlaCCine technology was demonstrated against various pathogens in multiple species and animal models. These presentations also demonstrated safety and immunogenicity of a PlaCCine vaccine targeting a SARS-CoV-2 spike variant in healthy human participants following intramuscular administration. Durable NAb responses to 6 months demonstrating vaccine immunogenicity following a single dose in previously vaccinated or infected individuals with the SARS-CoV-2 underscore the significance of the PlaCCine approach and support continued development in both naive populations using a prime and boost vaccination to determine optimal benefits and in other infectious diseases.

IMNN-101 has been shown to be safe and well tolerated, with no serious adverse effects reported. To accelerate the development and commercialization of the PlaCCine platform, IMUNON is actively seeking strategic partnerships with leading pharmaceutical and biotechnology companies. These collaborations aim to leverage PlaCCine’s unique advantages—enhanced durability, temperature stability, and scalable manufacturing—to address unmet needs in vaccines for infectious diseases and cancer, while securing non-dilutive funding to advance IMUNON’s broader oncology focused pipeline

THIRD QUARTER 2025 FINANCIAL RESULTS

Net loss for the third quarter of 2025 was $3.4 million, or $1.16 per share, compared with a net loss of $4.8 million, or $3.76 per share, for the third quarter of 2024. Operating expenses were $3.5 million for the third quarter of 2025, a decrease of $1.5 million or 30% from $5.0 million for the third quarter of 2024.

Research and development (R&D) expenses were $1.9 million for the third quarter of 2025, a decrease of $1.4 million from $3.3 million for the third quarter of 2024. The decrease was due primarily to lower costs associated with the OVATION 2 Study, the Phase 1 proof-of-concept PlaCCine DNA vaccine trial, and development of the PlaCCine DNA vaccine technology platform.

General and administrative (G&A) expenses were $1.6 million for the third quarter of 2025, compared with $1.7 million for the third quarter of 2024. This decrease was primarily attributable to lower employee-related expenses.

Investment income from short-term investments was $47,000 for the third quarter of 2025 compared to $116,000 for the same period in 2024 due to lower cash balances.

As of September 30, 2025, cash and cash equivalents were $5.3 million. During the third quarter of 2025, the Company received $4.5 million in net proceeds from the exercise of warrants and sales under its ATM facility. The Company believes it has sufficient capital resources to fund its planned operations into the first quarter of 2026.

NINE MONTHS ENDED SEPTEMBER 30, 2025 FINANCIAL RESULTS

For the nine months ended September 30, 2025, the Company reported a net loss of $10.3 million, or $5.53 per share, compared with a net loss of $14.6 million, or $14.13 per share, for the same nine-month period of 2024. Operating expenses were $10.4 million for the nine months ended September 30, 2025, a decrease of $4.6 million or 31% from $15.0 million for the same period in 2024.

Net cash used for operating activities was $10.2 million for the first nine months of 2025, compared with $14.4 million for the same period in 2024. This decrease was due to lower operating costs.

R&D expenses were $5.3 million in the first nine months of 2025, compared with $9.4 million in the same period of 2024. Clinical costs associated with the OVATION 2 and MRD trials were $0.2 million in the first nine months of 2025 compared to $1.1 million in the same period of 2024. Clinical costs associated with the OVATION 3 trial were $0.7 million in the first nine months of 2025. Clinical costs associated with the PlaCCine vaccine trial were $42,000 in the first nine months of 2025 compared to $1.4 million in the first nine months of 2024. Other clinical and regulatory costs were $1.4 million in the first nine months of 2025 compared to $1.9 million in the same period of 2024. R&D costs associated with the development of IMNN-001 to support the OVATION program were $2.2 million in the first nine months of 2025 compared to $0.9 million in same period of 2024. The cost of development of the PLACCINE DNA vaccine technology platform was $2.5 million in the first nine months of 2024. CMC costs were $0.7 million in the first nine months of 2025 compared to $1.6 million in the same period of 2024.

G&A expenses were $5.1 million in the first nine months of 2025, compared with $5.6 million in the same period of 2024. The decrease was primarily attributable to lower employee-related and professional service expenses and lower travel expenses.

Investment income was $117,000 in the first nine months of 2025, compared with $423,000 in the same period of 2024. This decrease is due to lower cash and investment balances.

Please note: All share and per share amounts in this press release have been adjusted to reflect a 15-for-1 reverse split of our common stock (which we effected on July 25, 2025) and all per share amounts in this press release have been adjusted for the 15% stock dividend (which we announced on July 28, 2025).

Conference Call and Webcast

The Company is hosting a conference call to review third quarter 2025 financial results and provide a business update today, November 13, 2025, at 11:00 a.m. ET. To participate in the call, please dial 833-816-1132 (Toll-Free/North America) or 412-317-0711 (International/Toll) and ask for the IMUNON Third Quarter 2025 Financial Results Call. A live webcast of the call will also be available here.

The call will be archived for replay until November 27, 2025, and 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 4592282. An audio replay of the call will also be available here for 90 days.

(Press release, IMUNON, NOV 13, 2025, View Source [SID1234659900])

On November 13, 2025 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported new and updated data from its hematology portfolio and pipeline will be shared across 14 abstracts at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2025 Annual Meeting, taking place from December 6-9 in Orlando, FL. Presentations highlight the next wave of potential novel approaches across a range of blood cancers and disorders.

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"This has been a landmark year for our Hematology program with U.S. and international regulatory approvals and launches for our blood cancer medicines," said L. Andres Sirulnik, M.D., Ph.D., Senior Vice President and Hematology Clinical Development Unit Head at Regeneron. "At ASH (Free ASH Whitepaper), our momentum continues with oral presentations on Lynozyfic as well as odronextamab in the frontline setting, which showcase how earlier interventions with our innovative approaches have the potential to benefit even more patients. We will also share updated results across our blood disorders pipeline, which reinforce our strategy of translating our deep expertise in hematology into meaningful progress where unmet needs remain."

Notable presentations from the Lynozyfic (linvoseltamab-gcpt) development program include an oral presentation on the Phase 1/2 LINKER-MM4 trial, which is the first to investigate the use of a bispecific monotherapy in newly diagnosed multiple myeloma (MM). New results will also be shared from the multicohort Phase 1b LINKER-MM2 trial evaluating linvoseltamab with two different anti-CD38 monoclonal antibodies in patients with relapsed/refractory (R/R) MM.

Progress on the odronextamab development program will be featured in six abstracts including an oral presentation on the first results of odronextamab plus chemotherapy from OLYMPIA-3 in previously untreated diffuse large B-cell lymphoma (DLBCL). Other presentations include the first results from Part 1 of two Phase 3 trials evaluating odronextamab in follicular lymphoma (FL) – odronextamab plus chemotherapy in frontline FL (OLYMPIA-2) as well as odronextamab plus lenalidomide in R/R FL (OLYMPIA-5).

Additional presentations include updated results for the novel combination of cemdisiran with pozelimab (cemdi-poze) compared to ravulizumab in paroxysmal nocturnal hemoglobinuria as well as the first-in-human evaluation of REGN7257 in severe aplastic anemia.

The full list of Regeneron presentations at ASH (Free ASH Whitepaper) includes:

Abstract Title Presentation ID Presenter Session Date/Time (ET)
Lynozyfic
Safety and efficacy of linvoseltamab as a simplified monotherapy first-line regimen in NDMM: Initial Results from the window of opportunity Phase 1/2 LINKER-MM4 trial​ #697

Oral Presentation Session 654 Robert Orlowski Sunday,
December 7 at 4:30 – 6:00 pm

West Hall E1
Safety and efficacy of linvoseltamab (LINVO) combined with anti-CD38 monoclonal antibodies (mAbs) daratumumab (DARA) or isatuximab (ISA) in patients (pts) with relapsed/refractory multiple myeloma (RRMM): Initial results from the multicohort, Phase 1b LINKER-MM2 trial
#2254

Poster Session 654 Meletios Dimopoulos Saturday,
December 6 at 5:30 – 7:30 pm

West Halls B3-B4
Odronextamab
Odronextamab plus chemotherapy in patients with previously untreated diffuse large B-cell lymphoma (DLBCL): First Results from part 1 of the Phase 3 Olympia-3 study #65

Oral Presentation
Session 629
Jean-Marie Michot
Saturday, December 6

at 9:30 – 11:00 am

Tangerine Ballroom F2

Efficacy and safety of long-term odronextamab treatment in patients with relapsed/refractory follicular lymphoma: 3-year follow-up from the Phase 2 ELM-2 study #3588

Poster Session 623

Jose Villasboas Bisneto
Sunday, December 7

at 6:00 – 8:00 pm

West Halls B3-B4

Odronextamab plus chemotherapy in patients with previously untreated follicular lymphoma: First results from part 1 of the Phase 3 Olympia-2 study #3600

Poster
Session 623
Kitsada Wudhikarn
Sunday, December 7

at 6:00 – 8:00 pm

West Halls B3-B4

Odronextamab (Odro) plus lenalidomide (+Len) in patients with relapsed/refractory (R/R) follicular lymphoma (FL): First results from part 1 (safety lead-in) of the Phase 3 OLYMPIA-5 study #5381

Poster
Session 623 Umberto Vitolo
Monday, December 8

at 6:00 – 8:00 pm

West Halls B3-B4

Phased variant circulating tumor DNA (ctDNA) tracking provides limited additional power in predicting progressive disease compared with duplex variant tracking in patients with Relapsed/Refractory (R/R) B-cell non-Hodgkin lymphoma (B-NHL) treated with odronextamab #5309

Poster Session 621 Jon Arnason Monday,
December 8 at 6:00 – 8:00 pm

West Halls B3-B4
Odronextamab treatment for patients with rare subtypes of relapsed/refractory (R/R) aggressive B-cell non-Hodgkin lymphoma (B-NHL): Updated efficacy and safety analyses from a dedicated cohort of the ELM-2 study #5523

Poster
Session 629

Farrukh Awan Monday,
December 8 at 6:00 – 8:00 pm

West Halls B3-B4
Cemdisiran and Pozelimab ("cemdi-poze")*
Efficacy and safety of pozelimab plus cemdisiran versus ravulizumab in patients with paroxysmal nocturnal hemoglobinuria who received prior C5 therapy #1420

Poster Session 508 Jun Ho Jang Saturday,
December 6 at
5:30 – 7:30 pm

West Halls B3-B4
Study design of A phase 3, open-label trial for pozelimab and cemdisiran combination therapy in patients with paroxysmal nocturnal hemoglobinuria with inadequate control of intravascular hemolysis #4988

Poster Session 508 Jun Ho Jang Monday,
December 8 at 6:00 – 8:00 pm

West Halls B3-B4
REGN7257
First-in-human evaluation of IL2RG blockade in patients with severe aplastic anemia that is refractory to or relapsed on immunosuppressive therapy #27

Oral Presentation
Session 508

Regis Peffault De Latour Saturday,
December 6 at
9:30 – 11:00 am

Hyatt – Plaza Int’l HIJK

Multiple Myeloma
Health care resource utilization in patients with multiple myeloma receiving bispecific antibody therapy with teclistamab: A Medicare claims database analysis in the US #3975

Poster
Session 653 Sikander Ailawadhi Sunday,
December 7 at 6:00 – 8:00 pm

West Halls B3-B4
Aplastic Anemia
Comprehensive multiproteomic analysis reveals an inflammatory phenotype in immune aplastic anemia characterized by broad activation of antigen presenting cells and t helper/cytotoxic 1.17 immune responses #3190

Poster Session 508 Audrey Le Floch-Ramondou
Sunday, December 7

at 6:00 – 8:00 pm

West Halls B3-B4

Longitudinal multiproteomic analysis reveals persistent underlying inflammation in acute graft-versus-host disease patients responding to corticosteroid treatment #2456

Poster Session 722 Audrey Le Floch-Ramondou
Saturday, December 6

at
5:30 – 7:30 pm

West Halls B3-B4

*Agreement with Alnylam Pharmaceuticals, Inc.

Cemdi-poze as well as REGN7257 are investigational, and the uses of linvoseltamab described above and of odronextamab in rare subtypes of R/R aggressive B-cell non-Hodgkin lymphoma are also investigational and have not been approved by any regulatory authority. Odronextamab is approved in the European Union as Ordspono for the treatment of R/R FL or DLBCL after two or more lines of systemic therapy, although its safety and efficacy have not been fully evaluated by any other regulatory authority.

(Press release, Regeneron, NOV 13, 2025, View Source [SID1234659916])

On November 13, 2025 JSR Life Sciences LLC ("JSR Life Sciences"), a global leader in life sciences materials and services, reported it has entered into a definitive agreement to transfer Crown Bioscience Inc. ("Crown Bioscience") to Adicon Holdings Limited ("Adicon"), a premier independent clinical laboratory provider in China and a portfolio company of The Carlyle Group. The transaction, subject to customary closing conditions, is expected to close in 2026.

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This strategic move will enable Crown Bioscience to operate as a standalone entity under Adicon’s ownership. Crown Bioscience’s comprehensive portfolio of translational oncology services, including its world-leading patient-derived xenograft (PDX) models, tumor organoid platforms, immuno-oncology assays, and bioinformatics solutions, will transition to Adicon, positioning the company to accelerate advancements in precision medicine and drug discovery for oncology.

Crown Bioscience’s Global Biospecimens business, headquartered in Hamburg, Germany, with facilities in Frederick, MD, will remain fully integrated within JSR Life Sciences. The Biospecimens team will continue to benefit from JSR’s robust global resources, innovation ecosystem, and focus on ethical sourcing, custom procurement, and advanced sample processing and storage capabilities.

"After careful strategic review, we believe this transaction represents an optimal path forward for both Crown Bioscience and JSR Life Sciences," said Tim Lowery, President and CEO of JSR Life Sciences. "Adicon’s deep domain expertise and financial backing from The Carlyle Group will empower Crown to scale its groundbreaking oncology services to new heights. As part of our long-standing onshore strategy, Crown remains firmly committed to serving clients through its global network of facilities, including its headquarters in San Diego and recent investments in the US and Europe. Initiatives like the launch of new Model Development Center in North Carolina and the expansion of biomarker and imaging capabilities in the UK ensure that customers have access to the same exceptional Crown experience, no matter where they choose to conduct their study."

Adicon, recognized as one of China’s largest independent clinical laboratory service providers, brings complementary strengths in high-throughput testing and data analytics to the partnership. Backed by global investment firm Carlyle’s extensive network and resources in healthcare and life sciences industry, Adicon is well-positioned to support Crown Bioscience’s growth trajectory.

Ms. Yang Ling, Chairwoman of Adicon and Head of Asia Healthcare at Carlyle, commented, "This acquisition represents an important milestone in Adicon’s growth journey. With Crown Bioscience’s world-class CRO capabilities, Adicon is expanding its reach across the global healthcare value chain– from clinical diagnostics to drug discovery and translational research. This transaction reinforces Adicon’s vision to become a trusted partner for biopharma innovation and precision diagnostics."

Until the transaction closes, Crown Bioscience will continue to operate as a wholly owned subsidiary of JSR Life Sciences, with no anticipated disruptions to ongoing services, projects, or customer relationships. JSR and Adicon are committed to a smooth transition, maintaining the highest standards of quality, compliance, and innovation across all operations.

(Press release, Crown Bioscience, NOV 13, 2025, View Source [SID1234659945])

On November 13, 2025 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported its business update and financial results for the first nine months of 2025.

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"This quarter highlights strong execution across our key programs," said Jonathan Dickinson, Chief Executive Officer of Innate Pharma. "With FDA clearance to initiate TELLOMAK-3, we are advancing lacutamab toward its confirmatory Phase 3 and potential accelerated approval in Sézary syndrome. We remain on track for dose-escalation data, from IPH4502, our Nectin-4 ADC, in the first half of 2026, followed by monalizumab PACIFIC-9 results in the second half of 2026. Together, these milestones position us well to deliver meaningful value for patients and shareholders as we continue to advance our differentiated portfolio."

Including short term investments (€6.1 million) and non-current financial instruments (€10.4 million).

Webcast and conference call will be held today at 2:00pm CET (8:00am ET)

The live webcast will be available at the following link:
View Source

Analysts may also join via telephone, click here to register: View Source

This information can also be found on the Investors section of the Innate Pharma website,
www.innate-pharma.com. A replay of the webcast will be available on the Company website for 90 days following the event.

*****

Pipeline highlights:

Strategic focus

As previously announced, Innate Pharma is prioritizing its investment on what it believes are its highest-value clinical assets, IPH4502, lacutamab, and monalizumab (partnered with AstraZeneca); and advancing the next Antibody Drug Conjugates (ADCs) toward development, leveraging its pipeline of innovative targets.

Lacutamab (anti-KIR3DL2 antibody):

Cutaneous T Cell Lymphoma

•The Company announced on November 10 that the U.S. Food and Drug Administration (FDA) has completed its review of the confirmatory Phase 3 protocol for lacutamab in cutaneous T-cell lymphomas (CTCL), with no further comments, clearing the trial to proceed.

•The planned confirmatory Phase 3 trial, TELLOMAK-3, is an open-label, randomized study designed to demonstrate the efficacy of lacutamab in patients with Sézary syndrome and Mycosis fungoides, who failed at least one prior line of systemic therapy. The trial will include two independent cohorts: one enrolling patients with Sézary syndrome post-mogamulizumab treatment randomized 1:1 to receive lacutamab or romidepsin, and one enrolling patients with Mycosis fungoides randomized 1:1 to receive lacutamab or mogamulizumab. The primary endpoint of the study for both cohorts is progression-free survival (PFS) evaluated by blinded central review.

•Data from the Phase 2 TELLOMAK trial in CTCL demonstrated durable activity, a favorable safety profile, and improvements in patients’ quality of life. With this feedback from FDA, the Company is progressing towards the initiation of the confirmatory Phase 3 TELLOMAK-3 trial in H1 2026. FDA provided encouraging initial feedback on Innate Pharma’s proposed regulatory pathway, which could potentially include Accelerated Approval for Sézary syndrome, once the Phase 3 trial is underway.

•The Company held a KOL event on October 28, 2025 on lacutamab and provided updates on the planned Phase 3 trial, the regulatory pathway in CTCL, and the commercial opportunity for lacutamab.

Peripheral T Cell lymphoma (PTCL)

•The Phase 2 KILT (anti-KIR in T Cell Lymphoma) trial, an investigator-sponsored, randomized controlled trial led by the Lymphoma Study Association (LYSA) to evaluate lacutamab in combination with chemotherapy GEMOX (gemcitabine and oxaliplatin) versus GEMOX alone in patients with KIR3DL2-expressing relapsed/refractory PTCL is ongoing and continues to recruit patients.

IPH4502 (Nectin-4 exatecan ADC):

•The Phase 1 trial will assess the safety, tolerability, and preliminary efficacy of IPH4502 in advanced solid tumors known to express Nectin-4, including but not limited to urothelial carcinoma, non-small cell lung, breast, ovarian, gastric, esophageal, and colorectal cancers. The study plans to enroll approximately 105 patients.

•The first patient was dosed in the Phase 1 study in January 2025. Enrollment of the dose escalation part continues to progress well and is expected to be completed at the end of 2025 or in the first quarter of 2026. Pharmacologically active dose has been reached.

Monalizumab (anti-NKG2A antibody), partnered with AstraZeneca:

•The Phase 3 PACIFIC-9 trial run by AstraZeneca evaluating durvalumab (anti-PD‑L1) in combination with monalizumab or AstraZeneca’s oleclumab (anti-CD73) in patients with unresectable, Stage III non-small cell lung cancer (NSCLC) who have not progressed following definitive platinum-based concurrent chemoradiation therapy (CRT) is ongoing. Enrollment in the trial is complete, and data readouts are expected in H2 2026.

Other Clinical stage assets

IPH6501 (ANKET anti-CD20 with IL-2V, proprietary): The Phase 1/2 clinical trial is evaluating IPH6501 in B-cell Non-Hodgkin’s lymphoma (B-NHL). The study is planned to enroll up to 184 patients. Clinical sites are open in the US, Australia, and France. Enrollment in the dose escalation phase of the trial is complete. Clinical data are expected to be presented in 2026.

IPH6101 (ANKET anti-CD123, proprietary): Innate regained the rights to SAR’579/IPH6101 in July 2025. Data from the Sanofi-led Phase 1/2 study and Phase 2 preliminary dose expansion of the trial have been transferred to Innate and the Company is evaluating potential next steps.

IPH5201 (anti-CD39 antibody, partnered with AstraZeneca): The MATISSE Phase 2 clinical trial conducted by Innate in neoadjuvant lung cancer for IPH5201, an anti CD39 blocking monoclonal antibody developed in collaboration with AstraZeneca, is ongoing, and recruitment is on track.

IPH5301 (anti-CD73, proprietary): The investigator-sponsored CHANCES Phase 1 trial of IPH5301 with Institut Paoli-Calmettes is ongoing.

Corporate update

•As previously announced, in line with its strategic focus, the Company intends to streamline its organization. Planned layoffs will be implemented through a redundancy plan, expected to be completed during the first half of 2026. A consultation with the Workers’ Council is ongoing and the plan is subject to endorsement by the French authorities (Dreets).

•The ATM program, pursuant to which it may, from time to time, offer and sell to eligible investors a total gross amount of up to $75 million of American Depositary Shares ("ADS") is still in place. As of September 30, 2025, no sales have been made under the program.

Financial Results

Cash, cash equivalents and financial assets of the Company amounted to €56.4 million as of September 30, 2025. At the same date, financial liabilities amounted to €24.8 million.

Revenues for the first nine months of 2025 amounted to €2.3 million (€10.2 million for the same period in 2024). For the nine-month period, ended September 30, 2025, revenue from collaboration and licensing agreements mainly resulted from the partial or entire recognition of the proceeds received pursuant to the agreements with AstraZeneca and Sanofi.

(Press release, Innate Pharma, NOV 13, 2025, View Source [SID1234659901])

On November 13, 2025 Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) ("Tiziana" or the "Company"), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, reported that its senior leadership team will present at the prestigious Jefferies London Healthcare Conference.

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Chief Executive Officer Ivor Elrifi and Chief Operating Officer/Chief Financial Officer Keeren Shah will deliver a corporate overview highlighting the Company’s innovative pipeline and recent clinical milestones. The session will include an update on the lead candidate foralumab, the only fully human anti-CD3 monoclonal antibody in clinical development administered intranasally for neurodegenerative diseases such as non-active secondary progressive multiple sclerosis (SPMS), Alzheimer’s disease (AD), multiple system atrophy (MSA) and amyotrophic lateral sclerosis (ALS).

The Jefferies London Healthcare Conference is one of Europe’s premier investor forums, attracting leading global healthcare companies, institutional investors, and industry thought leaders. Tiziana’s participation underscores its growing visibility within the biotechnology investment community and its commitment to advancing transformative therapies for patients with high unmet medical needs.

Presentation Details

Event: Jefferies London Healthcare Conference

Date: Wednesday, November 19, 2025

Time: 12:30 p.m. – 12:55 p.m. GMT (25-minute presentation)

Location: London, UK

Presenters:

● Ivor Elrifi, Chief Executive Officer

● Keeren Shah, Chief Operating Officer and Chief Financial Officer

Management will also be available for one-on-one meetings throughout the conference. Interested parties may request meetings through the Jefferies conference portal or by contacting Tiziana’s investor relations team.

(Press release, Tiziana Life Sciences, NOV 13, 2025, View Source [SID1234659917])