On November 24, 2025 Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, reported that Bob Jahr, Chief Executive Officer of Outlook Therapeutics, will participate in a fireside chat at the Piper Sandler 37th Annual Healthcare Conference on Tuesday, December 2, 2025 at 10:00 AM ET.

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In addition to the fireside chat, management will be available to participate in one-on-one in-person meetings with qualified members of the investor community who are registered to attend the conference.

A live webcast of the fireside chat will be accessible on the Events page in the Investors section of the Company’s website (outlooktherapeutics.com). The webcast replay will be archived for 90 days following the event.

(Press release, Outlook Therapeutics, NOV 24, 2025, View Source [SID1234660903])

On November 24, 2025 NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-stage clinical biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer and other major diseases, reported an operational update and financial results for the third quarter of 2025 along with an outlook for clinical updates from studies sponsored by Nanobiotix or The University of Texas MD Anderson Cancer Center ("MD Anderson") expected in 2026 and announced the closing of its non-dilutive royalty financing transaction with HCRx.

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Operational Highlights

Establishing the Financial Foundation for Self-sustained Long-term Growth
Closed the royalty financing transaction with Healthcare Royalty ("HCRx") triggering an upfront payment of $50 million
Nanobiotix expects to receive an additional $21 million in one year, subject to reaching certain conditions
Progressing JNJ-1900 (NBTXR3) Clinical Development
Presented first data from a Phase 1 MD Anderson study evaluating JNJ-1900 (NBTXR3) for patients with esophageal cancer presented at the 2025 Annual Meeting of the American Society for Radiation Oncology (ASTRO), adding another potential indication that warrants further investigation
Completed the sponsorship transfer of Phase 3 study evaluating JNJ-1900 (NBTXR3) for patients with locally advanced head and neck cancer who are ineligible for cisplatin (NANORAY-312) in the majority of regions, along with the transfer of full operational control of the Phase 3 study, to Johnson & Johnson ("J&J")
Advancing the Curadigm Nanoprimer Program
Four new patent applications filed to expand the Curadigm Nanoprimer intellectual property portfolio and support an initial proprietary internal pipeline of Nanoprimer-based products in addition to external collaborations
New in vivo pre-clinical data evaluating the Nanoprimer in combination with therapeutic vaccines presented at the 2025 Partnership Opportunities in Drug Delivery conference (PODD) that could serve as the foundation for an initial internal proprietary pipeline of Nanoprimer-based products
Momentum building for external collaborations featuring Nanoprimer platform combinations with numerous material transfer agreements already in place
Chemistry, Manufacturing, and Controls (CMC) activities launched to support internal pipeline and external collaborations

"2025 has been a year of strong execution against our strategic priorities, further accelerated by the momentum we built in the third quarter and to date," said Laurent Levy, Chief Executive Officer and Chairman of the Executive Board at Nanobiotix. "We took another disciplined financing step toward self-sustained, long-term growth through the closing of a non-dilutive strategic royalty monetization with HCRx. Clinically, we saw continued advancement of the JNJ-1900 (NBTXR3) program with completion of the Phase 3 head and neck cancer study sponsorship transfer to J&J in the majority of regions and first data from a Phase 1 esophageal cancer study supporting evaluation in yet another indication. In parallel, our Curadigm Nanoprimer program is rapidly emerging as a long-term growth driver for Nanobiotix. We are well positioned to accelerate our trajectory in 2026 and beyond."

Closing of the Royalty Financing Transaction

The closing of this royalty financing transaction with HCRx marks a significant milestone for the Company with an upfront payment of $50 million. The Company expects an additional $21 million in one year, subject to reaching certain conditions.

HCRx will be compensated and repaid out of a capped portion of milestones and royalties on sales of JNJ-1900 (NBTXR3) payable to Nanobiotix under the Janssen license agreement. This repayment and compensation will be implemented through a trust established between (i) Nanobiotix as settlor and beneficiary, (ii) HCRx funds as beneficiaries, and (iii) European Investment Bank ("EIB") as beneficiary. Furthermore, contractual covenants granted by Nanobiotix to HCRx regarding the proper implementation by Nanobiotix of the Janssen license agreement shall also benefit to EIB.

2026 JNJ-1900 (NBTXR3) Clinical Data Outlook for Studies Sponsored by Nanobiotix or MD Anderson

Final data from Nanobiotix Study 1100 evaluating JNJ-1900 (NBTXR3) followed by pembrolizumab or nivolumab anti-PD-1 checkpoint inhibitors for patients with primary cutaneous melanoma resistant to anti-PD-1
Updated data from a Phase 1 MD Anderson study evaluating JNJ-1900 (NBTXR3) for patients with locally advanced non-small cell lung cancer (NSCLC) who are amenable to re-irradiation
New data from expansion cohort of a Phase 1 MD Anderson study evaluating JNJ-1900 (NBTXR3) in combination with standard-of-care chemotherapy (capecitabine) for patients with locally advanced or borderline resectable pancreatic cancer
Updated results and establishment of the recommended Phase 2 dose (RP2D) from the proton therapy cohort of a Phase 1 MD Anderson study evaluating JNJ-1900 (NBTXR3) activated by photon or proton therapy for patients with locally advanced esophageal cancer
Third Quarter Financial Updates

Cash, Cash Equivalents and Operating Runway:

€20.4 million in cash and cash equivalents as of September 30, 2025
$50 million upfront payment to be received by Nanobiotix given the closing of the HCRx agreement, plus the additional $21 million expected one year post-closing upon reaching certain conditions, would extend cash visibility into early 2028
About JNJ-1900 (NBTXR3)

JNJ-1900 (NBTXR3) is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. Its proof-of-concept was achieved in soft tissue sarcomas through a successful randomized Phase 2/3 study in 2018. The product candidate’s mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that JNJ-1900 (NBTXR3) could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors.

Radiotherapy-activated JNJ-1900 (NBTXR3) is being evaluated across multiple solid tumor indications as a single agent or combination therapy. The program is led by NANORAY-312—a global, randomized Phase 3 study in locally advanced head and neck squamous cell cancers. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of JNJ-1900 (NBTXR3) activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy—the same population being evaluated in the Phase 3 study.

Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a collaboration strategy to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several Phase 1 and Phase 2 studies evaluating JNJ-1900 (NBTXR3) across tumor types and therapeutic combinations. In 2023, Nanobiotix announced a license agreement for the global co-development and commercialization of JNJ-1900 (NBTXR3) with Janssen Pharmaceutica NV, a Johnson & Johnson company.

(Press release, Nanobiotix, NOV 24, 2025, View Source [SID1234660902])

On November 24, 2025 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported that new data across multiple hematologic malignancies will be presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in Orlando, Fla. from Dec. 6-9. The data shared at the meeting will highlight the company’s ongoing commitment to advancing clinical research in hematology across Merck’s expanding and diverse pipeline of investigational candidates, with more than 20 abstracts being presented.

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"The data we’re sharing at ASH (Free ASH Whitepaper) 2025 reflect the continued growth and evolution of our promising hematology pipeline," said Dr. Gregory Lubiniecki, vice president, global clinical development, Merck Research Laboratories. "We continue to build on our leadership in oncology by advancing a diverse portfolio of investigational candidates and exploring novel modalities with the goal of improving outcomes and helping to address significant unmet needs for patients with hematologic neoplasms and malignancies."

Data presentations will feature Merck’s pipeline candidates, including: MK-1045, an investigational CD19xCD3 T-cell engager; bomedemstat (MK-3543), an investigational, orally available lysine-specific demethylase 1 (LSD1) inhibitor; and nemtabrutinib (MK-1026), an investigational, non-covalent Bruton’s tyrosine kinase (BTK) inhibitor. Additionally, Merck will present new and updated results highlighting zilovertamab vedotin (MK-2140), an investigational antibody-drug conjugate (ADC) that targets receptor tyrosine kinase-like orphan receptor 1 (ROR1).

Key data from Merck’s pipeline to be presented at the ASH (Free ASH Whitepaper) 2025 Annual Meeting and Exposition:

– First presentation by Merck of updated results from the dose escalation and expansion portion of a Phase 1b/2 study assessing the efficacy and safety of MK-1045 in adults with relapsed or refractory B-cell acute lymphoblastic leukemia (Abstract #647)
– First-time results from the Phase 2 Shorespan-004 study evaluating bomedemstat for patients with polycythemia vera (PV) resistant or intolerant to cytoreductive therapy (Abstract #83)
– Initial results from an exploratory analysis of the BELLWAVE-003 study of acquired resistance and prognostic mutations in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) treated with nemtabrutinib (Abstract #797)

Details on abstracts listed above and additional key abstracts for Merck:

Acute lymphoblastic leukemia

Updated results from the Phase 1b/2 study of MK-1045, a novel CD19xCD3 T-cell engager, in adult participants with relapsed or refractory B-cell acute lymphoblastic leukemia. Y. Wang.

Abstract #647, Oral session, Acute Lymphoblastic Leukemias: Therapies Excluding Allogeneic Transplantation

Polycythemia vera

Efficacy and safety of the LSD1 inhibitor bomedemstat in participants with polycythemia vera (PV) resistant or intolerant to cytoreductive therapy: the Phase 2 Shorespan-004 study. L. Rein.

Abstract #83, Oral session, Myeloproliferative Syndromes: Clinical and Epidemiological

Essential thrombocythemia

Shorespan-017: Phase 3 extension study for safety of bomedemstat in participants with essential thrombocythemia who received bomedemstat from a prior clinical study. M. Marchetti.

Abstract #2033, Poster session, Myeloproliferative Syndromes: Clinical and Epidemiological

Chronic lymphocytic & small lymphocytic lymphoma

Genomic assessment of acquired mutations in participants with CLL/SLL treated with nemtabrutinib in the Phase 2 BELLWAVE-003 study. T. Kipps.

Abstract #797, Oral session, Chronic Lymphocytic Leukemia: Clinical and Epidemiological

Nemtabrutinib plus venetoclax in relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma: results from the dose escalation and confirmation segment of the Phase 3 BELLWAVE-010 study. P. Ghia.

Abstract #2119, Poster session, Chronic Lymphocytic Leukemia: Clinical and Epidemiological

Marginal zone lymphoma

Phase 2 BELLWAVE-003 Cohort F: Updated clinical outcomes of nemtabrutinib in participants with relapsed or refractory marginal zone lymphoma. M. Ozcan.

Abstract #1801, Poster session, Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological

Follicular lymphoma

Nemtabrutinib in participants with relapsed or refractory follicular lymphoma: updated efficacy and safety from Cohort G of the Phase 2 BELLWAVE-003 study. W. Jurczak.

Abstract #3570, Poster session, Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological

Phase 1 study of MK-1045, a novel CD19xCD3 T-cell engager, in participants with relapsed or refractory follicular lymphoma. Y. Song.

Abstract #5372, Poster session, Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological

Diffuse large B-cell lymphoma

Phase 2/3 trial of zilovertamab vedotin plus standard of care in relapsed/ refractory diffuse large B-cell lymphoma: updated analysis of waveLINE-003. P. Armand.

Abstract #3745, Poster session, Aggressive Lymphomas, Immunotherapy including Bispecific Antibodies

Phase 2 trial of zilovertamab vedotin in combination with cyclophosphamide, doxorubicin, and prednisone plus rituximab in diffuse large B-cell lymphoma: updated analysis of waveLINE-007. M. Ladetto.

Abstract #5516, Poster session, Aggressive Lymphomas, Immunotherapy including Bispecific Antibodies

Phase 1 study of MK-1045, a novel CD19xCD3 T-cell engager, in participants with relapsed or refractory diffuse large B-cell lymphoma. Y. Song.

Abstract #3740, Poster session, Aggressive Lymphomas, Immunotherapy including Bispecific Antibodies

(Press release, Merck & Co, NOV 24, 2025, View Source [SID1234660900])

On November 24, 2025 Lineage Cell Therapeutics, Inc. reported it had achieved the first milestone available under its worldwide collaboration with Roche and Genentech, a member of the Roche Group, for OpRegen (RG6501), a suspension of human allogeneic retinal pigment epithelial (RPE) cells, currently in development for the treatment of geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD). The milestone was achieved based on manufacturing and clinical advancements related to the OpRegen cell therapy program.

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"We are excited to have achieved the first of the $620 million of milestone payments available under our collaboration with Roche and Genentech. The achievement of this milestone is rooted in our manufacturing expertise, which we deployed with the OpRegen cell therapy program, and reflects years of investment to optimize our in-house production processes and highlights the importance of having in-house control of complex manufacturing processes," stated Brian M. Culley, Lineage CEO. "Roche and Genentech are established leaders in ophthalmology, with a demonstrated and longstanding commitment to patients, innovative research, and successful product development, and we are proud to have reached this manufacturing milestone to support the Genentech team’s clinical efforts."

"Long-term clinical outcomes following a single administration of OpRegen cell therapy is challenging the view that GA causes irreversible damage. Clinical data reported at 12-, 24-, and 36-months for Cohort 4 of the Phase 1/2a study (12 patients) continues to demonstrate a consistent and durable treatment effect, with OpRegen-treated eyes exhibiting mean BCVA scores above baseline at each of these timepoints in these patients with less advanced disease. Notably, five patients who received significant coverage of OpRegen cell therapy across their GA lesion are demonstrating long-term outcomes consistent with meaningful disease stabilization and even improvement," added Mr. Culley.

RG6501 (OpRegen) is a suspension of human allogeneic retinal pigment epithelial (RPE) cells currently in development for the treatment of GA secondary to AMD. Subretinal delivery of OpRegen cell therapy has the potential to counteract RPE cell loss in areas of GA lesions by supporting retinal cell health and improving retinal structure and function. It is being developed under an exclusive worldwide collaboration between Lineage, Roche, and Genentech, a member of the Roche Group, and is currently being evaluated in a Phase 2a clinical study, GAlette, in patients with GA secondary to AMD (ClinicalTrials.gov Identifier: NCT05626114).

(Press release, Lineage Cell Therapeutics, NOV 24, 2025, View Source [SID1234660899])

On November 24, 2025 IN8bio, Inc. (the "Company") reported consolidated data, a summary of which is located below, from its investigator-sponsored Phase 1 single-center clinical trial of INB-200 and its Company-sponsored Phase 2 multi-center clinical trial of INB-400 for the treatment of patients with newly diagnosed glioblastoma ("GBM") in poster and oral presentations at the 2025 Society for Neuro-Oncology ("SNO") Annual Meeting on November 21 and 22, 2025.

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Summary of Clinical Update from Phase 1 Trial of INB-200 and Phase 2 Trial of INB-400

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Across the two trials, 17 patients were treated with the Company’s DeltExTM Drug Resistant Immunotherapy ("DeltEx DRI") gamma-delta T cells, with 14 patients receiving repeated (3 up to 6) doses. 10 additional patients were consented contemporaneously but received only the standard-of-care Stupp protocol ("SOC") and were monitored for progression and survival.

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Patients treated with repeated doses of DeltEx DRI cells achieved a median progression-free survival ("mPFS") of 13.0 months (n=14), compared to the mPFS of 6.6 months for patients receiving only SOC (n=10).

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Patients receiving repeated doses of DeltEx DRI cells have not yet reached median overall survival ("mOS"), which continues to climb at 16.4+ months as of October 31, 2025, while SOC patients attained a mOS of 11.0 months.

(Press release, In8bio, NOV 24, 2025, View Source [SID1234660898])