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Cellectar Biosciences Reports Third Quarter 2025 Financial Results and Provides Corporate Update

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.

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.
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).

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.

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.
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 [SID1234661043])

FENNEC PHARMACEUTICALS ANNOUNCES PROPOSED OFFERING OF COMMON SHARES

On November 13, 2025 Fennec Pharmaceuticals Inc. (NASDAQ:FENC) (TSX:FRX) ("Fennec" or the "Company"), a specialty pharmaceutical company, reported that it intends to offer and sell its common shares in an underwritten registered public offering. In addition, Fennec intends to grant the underwriters a 30-day option to purchase up to an additional 15% of its common shares sold in the public offering.

Fennec intends to use the net proceeds of the proposed offering to repurchase and redeem certain indebtedness and the remaining net proceeds, if any, for working capital and general corporate purposes.

Piper Sandler & Co. and Craig-Hallum Capital Group LLC are acting as the joint book-running managers for the proposed public offering.

The common shares are being offered by the Company pursuant to a registration statement previously filed with and declared effective by the Securities and Exchange Commission (the "SEC"). A preliminary prospectus supplement and an accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website located at View Source Copies of the preliminary prospectus supplement and the accompanying prospectus, when filed with the SEC, may also be obtained from Piper Sandler & Co., Attention: Prospectus Department, 350 North 5th Street, Suite 1000, Minneapolis, Minnesota 55401, by telephone at (800) 747-3924 or by email at [email protected] and Craig-Hallum Capital Group LLC, Attention: Equity Capital Markets, 323 North Washington Ave., Minneapolis, MN 55401, by telephone at (612) 334-6300 or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy common shares, nor shall there be any sale of common shares, in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. The common shares in the proposed offering will not be offered or sold, directly or indirectly, in Canada or to any resident of Canada.

(Press release, Fennec Pharmaceuticals, NOV 13, 2025, View Source [SID1234660017])

Translational Data and Significant Pathologic Response Rates from EFTISARC-NEO Phase II Highlighted in Oral Presentation at CTOS 2025

On November 13, 2025 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a late-stage immunotherapy company targeting cancer and autoimmune diseases, reported positive data from the EFTISARC-NEO trial that were detailed in an oral presentation by Paweł Sobczuk, M.D., Ph.D., Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland, at the Connective Tissue Oncology Society (CTOS) 2025 Annual Meeting held in Boca Raton, Florida.

The investigator-initiated Phase II study evaluating eftilagimod alfa (efti) with radiotherapy plus KEYTRUDA (pembrolizumab) in the neoadjuvant setting for resectable soft tissue sarcoma (STS) significantly exceeded the study’s prespecified level of pathologic response rates. In the evaluable patient population (N=38), the novel combination with efti reached a median 51.5% tumour hyalinization/fibrosis (p<0.001), meeting the study’s primary endpoint.1

These promising results were achieved in patients with ten different STS subtypes including rare and/or highly aggressive tumours with poor prognosis such as myxofibrosarcoma (N=16), undifferentiated pleomorphic sarcoma (N=10) and malignant peripheral nerve sheath tumor (N=2).

Early translational data from the initial twenty patients who underwent surgery in the trial show a strong immune system activation in line with efti’s mode of action, with statistically significant increases in the expression of key cytokines and chemokines in peripheral blood — specifically CXCL9, CXCL10, IL-23, and IFN-g.

Immune Response Biomarkers (fold change from week 1 through pre-surgery)

Serum Biomarker Fold change (p-value)
C-X-C motif chemokine ligand 9 (CXCL9)

2.5x (p<0.01)
C-X-C motif chemokine ligand 10 (CXCL10)

1.8x (p<0.0001)
Interleukin-23 (IL-23)

2.2x (p<0.05)
Interferon-gamma (IFN-g)

2.5x (p<0.05)
The increase on treatment of immune response biomarkers like IFN-gamma correlated with pathologic responses in this study, meaning patients with a biomarker increase during treatment also had a higher probability of a good clinical response at surgery.

The promising tumour hylanization/fibrosis rate achieved (over 3X greater than standard-of-care radiotherapy based on historical data)1 may hold significance in terms of future outcomes as it serves as an early surrogate endpoint correlated with enhanced overall survival and recurrence-free survival in STS patients.2,3 Disease-free survival and overall survival data are immature at this stage and will be presented in the future. Further correlative translational studies are also ongoing.

Dr. Paweł Sobczuk, one of the trial’s principal investigators, stated: "We are excited to share these strong results in resectable soft tissue sarcoma, a challenging indication with a high unmet medical need. This level of efficacy, observed across ten different STS subtypes including rare, highly aggressive tumours with poor prognosis, further supports the hypothesis that efti’s distinctive activation of antigen-presenting cells—and consequent induction of both adaptive and innate immunity—plays a key role in driving a coordinated immune response to fight cancer. This novel combination with neoadjuvant efti warrants further investigation in registrational settings."

"Our team was delighted to have recently been awarded the distinguished Golden Scalpel Award (Złoty Skalpel)* for EFTISARC-NEO. This honour is reserved for projects that demonstrate exceptional innovation and impact in medical research and clinical practice," added Dr. Sobczuk.

Dr. Frédéric Triebel, CSO of Immutep, said: "We are pleased to see a confirmation of earlier promising data on now 38 patients in this difficult-to-treat cancer. The prolonged increase in serum immune response biomarkers, observed two weeks after efti subcutaneous injection, is indicative of a robust adaptive and innate immune response. This enhanced immune activity is crucial because it means the body’s own defences are being mobilised to target and destroy cancer cells more effectively, further supporting the positive impact of the observed pathologic responses. The recent results suggest that efti may have potential applications beyond advanced or metastatic cancer, extending into earlier-stage disease."

As neoadjuvant immunotherapy becomes more established in the treatment of early-stage cancers, the findings from EFTISARC-NEO highlight the possibility for efti to be used in patients who have a lower tumor burden at diagnosis. This could expand the range of patients who might benefit from efti, potentially increasing its role in the treatment landscape for cancers that are still localized and resectable.

STS is an orphan disease with high unmet medical need and a poor prognosis for patients. The incidence of STS varies in different regions globally. In the United States, the number of new STS cases in 2025 is estimated to be ~13,520 with ~5,420 deaths, according to the American Cancer Society.4

For more information on EFTISARC-NEO, visit clinicaltrials.gov (NCT06128863). The CTOS 2025 oral presentation slides can be found on the Posters & Publications page of Immutep’s website.

*About the Golden Scalpel Award in Poland

The Golden Scalpel Award in Poland is recognized as a benchmark of excellence within the medical community. It is presented by independent experts to initiatives that set new standards in advancing healthcare. This year, EFTISARC NEO was the only oncology project to receive this accolade, underscoring its leadership and breakthrough potential in cancer treatment.

About Eftilagimod Alfa (Efti)

Efti is a novel immunotherapy that directly activates antigen-presenting cells or APCs (e.g. dendritic cells, monocytes) via the MHC Class II pathway to fight cancer. As an MHC Class II agonist, its activation of APCs engages the adaptive and innate immune system to initiate a broad anti-cancer immune response. This includes priming and activating cytotoxic T cells as well as generating important co-stimulatory signals & cytokines that further boost the immune system’s ability to combat cancer.

Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC) in a pivotal Phase III trial called TACTI-004 (KEYNOTE-F91), as well as head and neck squamous cell carcinoma (HNSCC), soft tissue sarcoma, and breast cancer. Its favourable safety profile enables various combinations like with anti-PD-[L]1 immunotherapy, radiotherapy, and/or chemotherapy. Efti has received Fast Track designation in first line HNSCC and in first line NSCLC from the United States Food and Drug Administration (FDA).

(Press release, Immutep, NOV 13, 2025, View Source [SID1234659971])

JSR Life Sciences Enters Definitive Agreement to Transfer Crown Bioscience to Adicon Holdings Limited

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.

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])

First Patient Dosed in SYNERGY-101, a Global, Randomized Phase 2 Clinical Trial of STK-012 in First-Line, PD-L1 Negative Nonsquamous Non-Small Cell Lung Cancer

On November 13, 2025 Synthekine Inc., an engineered cytokine therapeutics company, reported that the company has dosed the first patient in the SYNERGY-101 study. SYNERGY-101 is a global, randomized Phase 2 clinical trial evaluating STK-012 combined with pembrolizumab and chemotherapy (PCT) vs. PCT in first-line, PD-L1 negative nonsquamous non-small cell lung cancer (NSCLC).

"This marks a key milestone for Synthekine as we advance STK-012 into a randomized Phase 2 trial," said Debanjan Ray, Chief Executive Officer of Synthekine. "Our promising Phase 1b data suggest that STK-012 may lead to a meaningful improvement in outcomes in PD-L1 negative NSCLC, a population with limited benefit from current therapies."

Positive Phase 1b results presented at SITC (Free SITC Whitepaper) 2025 showed a 50% response rate in PD-L1 negative nonsquamous NSCLC patients treated with STK-012 in combination with PCT, substantially higher than the 23–32% response typically seen with standard of care alone. Notably, similarly high response rates were observed in patients with immune-resistant tumor profiles, such as those patients with STK11 or KEAP1 mutations, which have a high prevalence in PD-L1 negative NSCLC.

"PD-L1 negative patients represent 30-40% of new nonsquamous NSCLC diagnoses and typically face poor prognosis on standard-of-care therapy, highlighting the need for new treatment options in this setting," said Naiyer Rizvi, M.D., Chief Medical Officer of Synthekine. "SYNERGY-101 will help determine whether STK-012 can offer a new standard of care for this underserved population."

For additional information about the trial, please visit www.clinicaltrials.gov using the identifier NCT05098132.

About SYNERGY-101

SYNERGY-101 is a global, randomized Phase 2 study designed to evaluate the safety and efficacy of STK-012 in combination with PCT in first line, PD-L1 negative nonsquamous NSCLC patients. This trial aims to enroll approximately 105 patients, with a primary endpoint of overall response rate based on RECIST v1.1. Secondary endpoints include progression-free survival and safety.

About PD-L1 Negative Nonsquamous Non-Small Cell Lung Cancer

Lung cancer is the third-most common cancer in the United States and is a serious and life-threatening disease, which is expected to account for 20% of cancer deaths in 2025.1 Nonsquamous NSCLC is the most common form of lung cancer and PD-L1 negative patients account for 30 – 40% of these patients, who have a poor prognosis despite currently available standard-of-care therapies.

1Cancer Facts & Figures 2025, American Cancer Society (ACS), Atlanta, Georgia, 2025

About STK-012

STK-012 is a first-in-class α/β-IL-2 receptor biased partial agonist engineered to selectively stimulate antigen-activated T cells, which are associated with potent anti-tumor activity, while minimizing activation of other lymphocytes, such as natural killer (NK) cells or naïve T cells, which are associated with IL-2 related toxicity.

(Press release, Synthekine, NOV 13, 2025, View Source [SID1234659944])