On November 13, 2025 Enterome, a clinical-stage company pioneering OncoMimics, a new class of off-the-shelf, multi-targeted in vivo immune therapies that induce a fast and potent expansion of memory T-cells to fight cancer, reported positive new interim data from two cohorts of patients with low tumor-burden follicular lymphoma in the ongoing Phase 2 study of its lead OncoMimics immunotherapy EO2463. In cohort 3, data from the SIDNEY study showed a benign safety profile for EO2463 in combination with rituximab as first-line treatment for previously untreated patients with low tumor-burden follicular lymphoma in need of treatment, adding only injection site reactions to the well-known safety profile of rituximab. In addition, all six patients in this feasibility assessment responded to the combination treatment.

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Data from cohort 2 continue to show that EO2463 monotherapy produces excellent response rates when offered to patients with newly diagnosed follicular lymphoma or marginal zone lymphoma as an alternative to standard watchful waiting, an unmet clinical need setting. Per the abstract, data from 19 evaluable patients as of July showed an overall response rate (ORR) of 47%, including 3 complete responses (CRs) and 6 partial responses (PRs). No treatment is given to patients who currently follow the standard watch and wait setting practice as long as they do not show troublesome symptoms, despite the fact that they can remain anxious about their disease, and have a decreased quality of life.

The company will present the next update on both sets of data at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) meeting in Orlando, Florida, in December.

"These encouraging data further strengthen our conviction in the broad potential of EO2463 as a novel active immunotherapy. The data from the "watch-and-wait" setting confirm our earlier positive findings, while those from cohort 3 – which we had not reported on before – point in the same direction," said Jan Fagerberg, Chief Medical Officer at Enterome.

"This is another exciting set of new data, ahead of our lead asset EO2463 entering Phase 3 testing in the "watch-and-wait" setting in 2026. The data come shortly after we received Fast Track designation for EO2463 from the U.S. FDA for the watch-and-wait setting, raising our confidence that Enterome’s OncoMimics platform has the potential to be applied across a broad range of cancers," said Pierre Belichard, Chief Executive Officer of Enterome.

Details of the poster presentations:

Abstract #5377

Title: EO2463 (EO) peptide immunotherapy in patients (pts) with newly diagnosed asymptomatic follicular lymphoma (FL) and marginal zone lymphoma (MZL): Study EONHL1-20/SIDNEY (NCT04669171) primary endpoint Lugano objective response analysis
Presenting Author: Jose Caetano (JC) Villasboas, MD Mayo Clinic
Session: 623. Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster III
Session date: 7 December 2025
Presentation time: 06:00-08:00 PM
Location: Room OCCC, West Halls B3-B4

Abstract #3594

Title: EO2463 (EO) peptide immunotherapy combined with rituximab (R) for first-line treatment of low-tumor burden follicular lymphoma (FL): A feasibility evaluation in Study EONHL1-20/SIDNEY (NCT04669171)
Presenting Author: Stephen Smith, M.D., UW Medicine, Fred Hutchinson Cancer Research Center
Session: 623. Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological
Session date: 8 December 2025
Presentation time: 06:00-8:00 PM
Location: Room OCCC, West Halls B3-B4

Follicular Lymphoma, one of several types of indolent Non-Hodgkin Lymphoma, is a difficult to treat chronic condition with relapses, characterized by slow progression and few symptoms, and reduced life expectancy. It is usually diagnosed by the appearance of swollen lymph nodes, and the early stages of the disease can be characterized by a lack of troublesome symptoms such as night sweats, fever or weight loss. There is a widespread consensus among leading investigators on the need for a well-tolerated and effective monotherapy to stop or slow progression for patients in the watch-and-wait setting.

EO2463 is an innovative, off-the-shelf OncoMimics active immunotherapy that combines four synthetic peptides. These non-self, microbial-derived peptides correspond to CD8 HLA-A2 epitopes that exhibit molecular mimicry with the B lymphocyte-specific lineage markers CD20, CD22, CD37, and CD268 (BAFF receptor). It also includes the helper peptide (CD4+ epitope) universal cancer peptide 2 (UCP2). The unique ability of EO2463 to selectively target multiple B cell markers enables the destruction of malignant B lymphocytes. By ensuring broad target coverage across malignant B cells, this novel approach aims to simultaneously improve safety and maximize efficacy, reducing the tumor cells’ capacity to develop immune-resistance mechanisms such as antigen escape.

OncoMimics consist of bacteria-derived peptide antigens that closely mimic tumor-associated antigens (TAAs). These antigens induce a fast and potent in vivo expansion

of cytotoxic memory CD8+ T cells that were primed by gut bacteria, and are cross-reactive with TAAs. Because the peptides are "non-self", OncoMimics avoid the self-tolerance that limits many cancer immunotherapies to enable rapid, potent, and durable responses to tumors. The synthetically produced peptides are designed in silico, mining Enterome’s proprietary database of 23 million commensal bacteria genes. Each product combines multiple high-affinity peptides to broaden target coverage and mitigate tumor heterogeneity.

OncoMimics are easy to manufacture, store, distribute and administer as an "off-the-shelf" subcutaneous injection. OncoMimics have achieved rapid and potent responses in clinical testing in over 230 patients to date, with a benign safety profile.

(Press release, Enterome, NOV 13, 2025, View Source [SID1234659898])

On November 13, 2025 Delcath Systems, Inc. (Nasdaq: DCTH), ("Delcath" or the "Company") an interventional oncology company focused on the treatment of primary and metastatic liver cancers, reported the publication of results from a retrospective analysis conducted by researchers at the University of Tubingen, Germany. The study, titled "Characterization of long-term survivors with liver metastases from uveal melanoma diagnosed between 2005 and 2021," was published in the International Journal of Cancer and highlights the potential benefits of early use of liver-directed therapies, including chemosaturation (also known as percutaneous hepatic perfusion or PHP), in achieving long-term survival for patients with metastatic uveal melanoma (mUM) and liver metastases. The analysis underscores PHP’s advantages in disease control compared to other therapies, supporting its early integration potentially ahead of systemic options or in combination with systemic therapies.

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The retrospective analysis evaluated 167 patients with mUM who developed liver metastases between 2005 and 2021, focusing on the 33 long-term survivors (20% of the cohort) who lived three or more years following the initial diagnosis of liver metastases. Key findings include:

The majority of long-term survivors (82%) received liver-directed therapy as their first-line treatment in the metastatic setting
90% of long-term survivors received at least one liver-directed therapy at any time, with 85% also receiving immune checkpoint inhibitors (ICI) at some point
In patients who received first line liver-specific therapy, response evaluation showed a disease control rate of 93% (complete response, partial response, or stable disease) versus 63% for patients who received first line systemic therapy
52% percent of long-term survivors received PHP at any time point, achieving a median overall survival of 37.35 months and progression-free survival of 10.28 months
"The retrospective analysis from the University of Tubingen provides compelling real-world evidence supporting the early integration of liver-directed therapies such as PHP into the treatment of metastatic uveal melanoma. This potentially contributes to long-term survival in a disease with historically poor outcomes-particularly through PHP’s demonstrated 100% disease control rate when used as first line liver-specific therapy, outperforming other options," said Gerard Michel, Chief Executive Officer of Delcath Systems. "Building on the positive results from the CHOPIN trial, which demonstrated significant improvements in progression-free and overall survival when combining PHP with immune checkpoint inhibitors in first-line treatment of patients with metastatic uveal melanoma, the results reinforce the value of HEPZATO KIT and CHEMOSAT as foundational components of multimodal treatment strategies, including initiating PHP as part of a first line treatment strategy that includes immune checkpoint inhibitors."

Notably, all patients (100%) who received PHP as their first liver-directed therapy achieved disease control, with 69% experiencing partial tumor response – demonstrating superior efficacy compared to other liver-directed therapies.

The authors highlight the combination of PHP for hepatic metastases control and ICI for extrahepatic metastases control appears reasonable and shows association with better outcomes, with 15 patients in the cohort of long-term survivors receiving both therapies. They suggest initiating PHP first in multimodal strategies to potentially enhance ICI efficacy, especially given the liver’s role in inducing tumor immune tolerance to ICI therapy.

The study utilized chemosaturation with Delcath’s CHEMOSAT Hepatic Delivery System, which employs the same proprietary technology as the U.S. Food and Drug Administration (FDA) approved HEPZATO KIT (HEPZATO (melphalan) for Injection/Hepatic Delivery System). This analysis builds on prior publications from the same research group, including Wiens et al. (2024) in Therapeutic Advances in Medical Oncology, which reported significantly improved melanoma-specific survival (28 months) with first-line liver-directed therapies compared to systemic therapies (10 months), and a poster presentation by Laukhuf et al. at the European Association of Dermato-Oncology (EADO) Congress in April 2025, which initially characterized long-term survivors in this cohort.

(Press release, Delcath Systems, NOV 13, 2025, View Source [SID1234659897])

On November 13, 2025 Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) ("Day One" or the "Company"), a biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, reported it has signed a definitive merger agreement for Day One to acquire Mersana Therapeutics, Inc. ("Mersana").

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The transaction positions the Company for continued success and expansion of its oncology portfolio, adding Emi-Le, a potential first-in-class monotherapy for patients with ACC, an aggressive cancer with a well-defined patient population and high unmet need, most often arising from the salivary gland. The early anti-tumor activity observed with Emi-Le in an ongoing Phase 1 study, in a disease with a clear unmet medical need, may support a fast path to registration. Emi-Le represents an innovative and differentiated ADC directed against B7-H4, a well-characterized target in certain cancers. B7-H4 is highly expressed in ACC as well as in other adult and pediatric cancers. As a novel targeted investigational agent with monotherapy anti-tumor activity intended for a well-defined patient population without any approved therapies or a clear standard of care, the Company believes that Emi-Le is well positioned for potential rapid development and commercialization.

"This acquisition will add a potential game-changing new medicine to the Day One portfolio and, if approved, will broaden our opportunities for patient impact and for continued growth and value creation," said Jeremy Bender, Ph.D., chief executive officer of Day One. "The addition of the Emi-Le program to our portfolio allows us to leverage the research and development expertise, and the commercial capabilities, that already exist within Day One to address underserved, rare and life-threatening cancers in patients of all ages."

Terms of the Agreement

Under the terms of the definitive merger agreement, Day One will promptly commence a tender offer to acquire all of the outstanding shares of Mersana common stock at a price of $25 per share in cash at closing plus one non-tradable CVR per share to receive certain potential milestone payments of up to an aggregate of $30.25 per CVR in cash, for total consideration of up to $55.25 per share in cash, representing a total equity value of approximately $129 million at closing and representing a total deal value of up to approximately $285 million. The CVR is payable subject to certain terms and conditions of achievement of the following milestones:

Clinical Milestones

· A development milestone related to an existing partnership agreement: $1.25 per share

· Breakthrough Therapy Designation for ACC granted by FDA: $1.00 per share

· First dosing of a participant in a registrational trial of Emi-Le for ACC-1: $4.00 per share

Regulatory/Sales Milestones

· Regulatory approval granted by FDA in Emi-Le for ACC-1: $9.00 per share

· First commercial sale of Emi-Le in a major EMA market: $2.00 per share

· First commercial sale of Emi-Le in Japan: $1.00 per share

· Annual net sales of Emi-Le exceed $100 million by 2032: $2.00 per share

· Annual net sales of Emi-Le exceed $200 million by 2035: $4.00 per share

· Annual net sales of Emi-Le exceed $300 million by 2037: $6.00 per share

Day One expects to finance the acquisition with existing cash resources. Day One’s strong cash position and financial profile is expected to enable development of Emi-Le through potential approval with no additional financing required.

The transaction is expected to close by the end of January 2026, subject to receipt of applicable regulatory approvals and the satisfaction of other customary conditions.

Advisors

Gordon Dyal & Co., LLC is acting as the exclusive financial advisor to Day One, with Fenwick & West LLP serving as legal counsel. TD Cowen is acting as financial advisor to Mersana, with Wilmer Cutler Pickering Hale and Dorr LLP serving as legal counsel.

Conference Call

Day One will host a conference call and webcast today, Nov. 13 at 8:00 am Eastern Time. To access the live conference call by phone, dial 877-704-4453 (domestic) or 201-389-0920 (international), and provide the access code 13757215. Live audio webcast will be accessible from the Events page. To ensure a timely connection to the webcast, it is recommended that participants register at least 15 minutes prior to the scheduled start time. An archived version of the webcast will be available for replay on the Events section of the Day One Media & Investors page for 30 days following the event.

(Press release, Day One, NOV 13, 2025, View Source [SID1234659896])

On November 13, 2025 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologics, reported that Sean McCarthy, D.Phil., chief executive officer and chairman, will participate in a fireside chat at the Jefferies Global Healthcare Conference in London on Thursday, November 20, 2025, at 9:00 a.m. GMT.

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A live webcast of the presentation will be available on the Events and Presentations page of CytomX’s website at www.cytomx.com. In addition, management will be available for one-on-one meetings with investors who are registered to attend the conferences.

(Press release, CytomX Therapeutics, NOV 13, 2025, View Source [SID1234659895])

On November 13, 2025 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, reported financial results for the quarter ended September 30, 2025, and provided a corporate update.

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"Our productive engagement with the European Medicines Agency (EMA) highlighted by confirmation of eligibility to submit for a conditional marketing authorization marks a significant step forward in our global regulatory strategy, bringing us closer to potential approval and commercialization of iopofosine I-131 for WM in 2027. In parallel, additional data from the CLOVER WaM study and the receipt of breakthrough designation from the FDA continues to support a path toward a New Drug Application for accelerated approval," stated James Caruso, president and CEO of Cellectar. "We believe this regulatory pathway, combined with the compelling clinical results we’ve seen to date, reinforces the value of iopofosine and positions it as a highly attractive asset for collaboration or strategic partnership.

"Looking ahead, we are excited to further advance our promising radioconjugate pipeline of auger- and alpha-emitting drug candidates and have initiated a Phase 1b trial for CLR 125 in triple-negative breast cancer, which builds on strong preclinical data showing reduction or inhibition of solid tumor growth. We are also progressing our early-stage asset, CLR 225, which has shown robust anti-tumor activity in pancreatic cancer models, and has recently completed IND-enabling studies. Each of these achievements brings us closer to our goal of transforming the outlook for patients facing aggressive and life-threatening cancers," concluded Mr. Caruso.

Third Quarter and Subsequent Corporate Highlights

· Advised by the Scientific Advice Working Party (SAWP) of the European Medicines Agency (EMA) that filing for a Conditional Marketing Approval (CMA) for iopofosine I 131 as a treatment for post-Bruton Tyrosine Kinase inhibitor (BTKi) refractory patients with Waldenstrom macroglobulinemia (WM) could be acceptable for CMA.

· Plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the accelerated approval of iopofosine I 131 as a treatment for WM once the confirmatory trial is underway, which is subject to sufficient funding.

o The Phase 3 study for iopofosine I 131, a potentially first-in-class, targeted radiotherapeutic candidate for the treatment of relapsed/refractory WM will be a comparator, randomized controlled study with approximately 100 patients per arm with full patient enrollment projected within 18-24 months of the first patient admitted to the study.

· The Company has received clearance for its Investigational New Drug application for CLR 125, the Company’s lead Auger-emitting (iodine-125) PRC for a Phase 1b/2a dose finding study in triple-negative breast cancer. CLR 125 provides the greatest precision in targeted radiotherapy as emissions only travel a few nanometers.

o The Company announced a partnership with Evestia Clinical to provide CRO services to support their upcoming Phase 1b study evaluating CLR 125 for the treatment of triple-negative breast cancer (TBNC).

· Received rare pediatric drug designation (RPDD) for iopofosine I 131 in inoperable relapsed or refractory pediatric high-grade glioma (r/r pHGG).

o Interim data from the Phase 1b dose and optimization study, CLOVER-2, was highlighted in an oral presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference on Pediatric Cancer. Results showed extended progression-free survival along with overall survival, and iopofosine I 131 was well tolerated and its toxicity profile was consistent with the Company’s previously reported safety data.

· Presented preclinical data from CLR 121225 (CLR 225), a novel actinium-based radio conjugate alpha-emitter for treatment of hypoxic pancreatic ductal adenocarcinoma (PDAC) at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference on Pancreatic Cancer Research. In three separate pancreatic cancer xenograft models, CLR 225 demonstrated inhibition of tumor growth or reduction in tumor volume, dependent on dose, with potential survival benefit following treatment.

o The Company has entered into a supply agreement with ITM Isotope Technologies Munich (ITM) for Actinium-225 (Ac-225), which will support clinical development of Cellectar’s actinium-labeled compound CLR 225.

o CLR 225 has completed the required Investigational New Drug (IND)-enabling studies and the company maintains the option to move into a Phase 1 study. Previous data from CLR 225 has demonstrated activity in multiple solid tumor animal models, including pancreatic, colorectal and breast cancer.

· Raised approximately $12.7 million. These funds will be used to advance the Company’s TNBC study and to complete the EMA Conditional Marketing Authorization application for iopofosine I 131 for WM.

Third Quarter 2025 Financial Highlights

· Cash and Cash Equivalents: As of September 30, 2025, the company had cash and cash equivalents of $12.6 million, compared to $23.3 million as of December 31, 2024. The company believes its cash balance as of September 30, 2025, is adequate to fund its budgeted operations into the third quarter of 2026. Following the close of the third quarter in October 2025, several institutional investors exercised certain existing warrants for gross proceeds to the company of approximately $5.8 million prior to deducting placement agent fees and estimated offering expenses.

· Research and Development Expenses: R&D expenses for the three months ended September 30, 2025, were approximately $2.5 million, compared to approximately $5.5 million for the three months ended September 30, 2024. The overall decrease was primarily a result of reduced clinical trial costs.

· General and Administrative Expenses: G&A expenses for the three months ended September 30, 2025, were approximately $2.3 million, compared to approximately $7.8 million for the same period in 2024. The decrease was primarily driven by lower commercialization and personnel costs.

· Net Loss: The net loss attributable to common stockholders for the three months ended September 30, 2025, was $4.4 million, or $1.41 per basic and diluted share, compared to a net loss of $14.7 million, or $11.18 per basic and $12.13 per diluted share in the three months ended September 30, 2024.

Conference Call & Webcast Details

Cellectar management will host a conference call and webcast today, November 13, 2025, at 8:30 AM Eastern Time to discuss these results and answer questions. Stockholders and other interested parties may participate in the conference call by dialing 1-800-717-1738. A live webcast of the conference call can be accessed in the "Events & Presentations" section of Cellectar’s website at www.cellectar.com. A recording of the webcast will be available and archived on the Company’s website for approximately 90 days.

(Press release, Cellectar Biosciences, NOV 13, 2025, View Source [SID1234659894])