On November 13, 2025 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, reported financial results for the third quarter ended September 30, 2025, and provided a corporate update.

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"This quarter we continued to make strong progress across our clinical pipeline," said Paul Peter Tak, M.D., Ph.D., FMedSci, President and CEO of Candel. "We continue to work toward a planned BLA submission in Q4 2026. We presented additional supportive data from our positive phase 3 trial of CAN-2409 in newly diagnosed, localized prostate cancer during an oral presentation at the Association of Radiation Oncology (ASTRO) Annual Meeting, demonstrating that CAN-2409 improved prostate cancer-specific DFS, independent of the type of external beam radiation therapy used, extending the results presented during an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. We also presented data during an invited lecture at the Annual Meeting of the Prostate Cancer Foundation. We continue to follow the patients enrolled in the phase 3 study for prostate cancer-specific outcomes and expect the first results after extended follow-up in Q2 2026. In addition, in collaboration with the U.S. Food and Drug Administration, we designed a supportive, mechanistic clinical trial of CAN-2409 in localized prostate cancer. We plan to release immunologic biomarker data from this study in Q3 2026. Furthermore, we reported encouraging survival data from our phase 1b clinical trial of CAN-3110 in patients with rHGG, most of whom had recurrent glioblastoma, supported by sophisticated brain biopsy analyses. Mature overall survival data for Arm C are expected in Q4 2026. Together, the data supports the design of a randomized controlled phase 2 clinical trial of CAN-3110 in recurrent glioblastoma. Finally, we strengthened our Research Advisory Board with the appointments of Dr. Carl H. June and Dr. Bali Pulendran, underscoring our continuous commitment to scientific excellence and to advancing immunotherapies that may meaningfully improve the lives of patients with devastating cancers."

Dr. Tak continued, "On the financial front, we were pleased to secure strategic, non-dilutive funding through a five-year, $130 million term loan facility with Trinity Capital, Inc., which strengthens our balance sheet and positions us to advance our key priorities, including the initiation of a pivotal phase 3 clinical trial of CAN-2409 in NSCLC and the potential commercial launch of CAN-2409 in localized prostate cancer. We expect updated data on long-term survivors from our phase 2 study in NSCLC in Q1 2026 and anticipate initiation of the phase 3 study in Q2 2026. We look forward to sharing more details on our progress and strategic vision at our virtual Research and Development event in Q4 2025."

Third Quarter 2025 & Recent Highlights

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CAN-2409 (aglatimagene besadenovec) – Prostate Cancer
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In an oral presentation at the 2025 ASTRO Annual Meeting, the Company presented subgroup analyses focused on the radiation regimen used during its positive phase 3 clinical trial of CAN-2409 in patients with intermediate-to-high-risk localized prostate cancer. Data were presented by Glen Gejerman, M.D., M.B.A., Co-Director of Urologic Oncology at Hackensack Meridian Health and one of the principal investigators of the study.

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CAN-2409 demonstrated statistically significant improvement in prostate cancer-specific DFS (Hazard Ratio (HR) 0.62; p=0.0046). Effects were observed with both moderate hypo-fractionated external beam radiation therapy (EBRT) (HR 0.52, CI 0.30 – 0.93, p=0.0236) and conventional EBRT (HR 0.76, CI 0.53 – 1.07, p=0.1131).
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CAN-2409 administration was safe across radiation therapy modalities, with both conventional radiation therapy (~78 Gy in 2 Gy fractions, ~72% of patients) and moderate hypofractionated radiation therapy (60 Gy in 3 Gy fractions, ~25% of patients), showing similar tolerability profiles. Grade ≥ 3 treatment related adverse events were similar in the CAN-2409 plus valacyclovir and placebo arms with both hypofractionated (1.6% vs. 1.9%) and standard EBRT (1.8% vs. 1.1%), respectively.
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The U.S. Food and Drug Administration (FDA) previously granted Fast Track Designation and Regenerative Medicine Advanced Therapy Designation to CAN-2409 for the treatment of prostate cancer; the phase 3 clinical trial of CAN-2409 in localized prostate cancer was conducted under a Special Protocol Assessment agreed to with the FDA.
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The Company is advancing its pre-BLA readiness, including through its Chemistry, Manufacturing, and Controls (CMC) activities, and preparation of clinical study reports and BLA modules.
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CAN-2409 – Non-Small Cell Lung Cancer (NSCLC)
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Following a positive end-of-phase 2 meeting with the FDA in July 2025, the Company is preparing to initiate a pivotal phase 3 clinical trial of CAN-2409 in NSCLC in Q2 2026.
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The FDA previously granted Fast Track Designation to CAN-2409 for the treatment of NSCLC.
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CAN-2409 – Pancreatic Cancer
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The Company previously generated encouraging data based on a randomized controlled phase 2a clinical trial of CAN-2409 in borderline resectable pancreatic cancer (PDAC). The FDA previously granted Fast Track Designation and Orphan Drug Designation to CAN-2409 for the treatment of PDAC and the European Medicines Agency granted Orphan Designation for CAN-2409 for the treatment of pancreatic cancer in July 2025.
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With Candel’s top priorities focused on prostate cancer and NSCLC, the Company will pause the PDAC program, unless it is funded through external, non-dilutive funding.
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CAN-3110 (linoserpaturev) – Recurrent High-Grade Glioma (rHGG)

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In October 2025, the Company reported encouraging updated survival data for all patients enrolled in its phase 1b clinical trial of CAN-3110 in rHGG:
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Updated median overall survival (mOS) was 11.8 months (CI: 8.3–14.9) for arm A (n = 41) and 12.0 months (CI: 10.0–NA) for arm B (n = 9) after a single injection of CAN-3110, consistent with previously reported data for arms A and B. At the time of data cutoff (August 15, 2025), one patient from arm A and one patient from arm B were still alive after prolonged follow-up (59.2 and 42.4 months, respectively, after CAN-3110 administration). The FDA previously granted Fast Track Designation and Orphan Drug Designation to CAN-3110 in recurrent high-grade glioma based on an earlier data cut.
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At data cutoff as of August 15, 2025, 9 patients in arm C had received multiple administrations of CAN-3110. At the 1×10⁸ PFU dose, 3 patients received 4 injections, 1 patient received 5 injections, and 2 patients received 6 injections. At the 1×10⁷ PFU dose, 1 patient received 4 injections, and 2 patients received 5 injections. Median follow-up was 8.9 months. Four out of 9 patients were alive at time of data cutoff (range 3.1-28.2 months after initiation of CAN-3110 treatment). Five patients had died, of which 3 died more than one year after initiation of CAN-3110 treatment (range 5.5-21.8 months).
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Candel also announced the scientific publication, "Serial Multiomics Uncovers Anti-Glioblastoma Responses Not Evident by Routine Clinical Analyses," in the journal Science Translational Medicine. Led by E. Antonio Chiocca, M.D., Ph.D., Executive Director of the Center for Tumors of the Nervous System at the Mass General Brigham Cancer Institute, as part of the multi-institutional Break Through Cancer Accelerating GBM Therapies Through Serial Biopsies TeamLab, the publication presents findings from the comprehensive analysis of 97 serial tumor biopsies collected from two patients treated with repeated administrations of CAN-3110 in arm C of the ongoing phase 1b clinical trial (NCT03152318).
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Together, the encouraging data supports the Company’s plans to design a randomized controlled phase 2 clinical trial of CAN-3110 in recurrent glioblastoma.
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Recent Corporate Events
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The Company presented insights into the third preclinical candidate from its enLIGHTEN Discovery Platform in a mouse model of breast cancer, as well as additional data from the CAN-2409 program in NSCLC, through two accepted poster presentations, along with an invited faculty presentation and panel discussion by Paul Peter Tak, M.D., Ph.D., FMedSci, Candel’s President and CEO, showcasing the phase 3 clinical trial of CAN-2409 in newly diagnosed, localized prostate cancer at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 40th Anniversary Annual Meeting.

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In October 2025, Candel entered into a $130 million term loan facility with Trinity Capital Inc. (Nasdaq: TRIN). The loan facility consists of four tranches, with the first tranche of $50 million drawn upon closing of the agreement. The second and third tranches totaling $50 million in the aggregate are available to be drawn subject to the achievement of certain regulatory, clinical and operational milestones, subject to certain conditions precedent described in the agreement, and the fourth tranche of $30 million is available at the lender’s discretion. The loan facility has a five-year term with an interest-only period of 36 months, which is extendable for an additional 12 months upon the achievement of a certain commercial milestone. The loan facility contains customary representations, warranties, covenants, and events of default.
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In September 2025, the Company appointed Carl H. June, M.D., to its Research Advisory Board (RAB). Dr. June is an internationally recognized expert in cancer immunotherapy, and a pioneer in developing the first FDA-approved CAR-T cell therapy.
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In October 2025, the Company appointed Bali Pulendran, Ph.D., to its RAB. Dr. Pulendran is an internationally recognized expert in systems immunology and vaccinology, who has pioneered the use of systems’ approaches to understand human immune responses.
Anticipated Milestones

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Candel will host a Virtual R&D Day on Friday, December 5, 2025.
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Updated mOS data and "long tail" of survival analysis from the phase 2a open-label clinical trial of CAN-2409 in patients with stage III/IV NSCLC who had progressed, despite ICI treatment (NCT04495153) is expected in Q1 2026.
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Updated data on prostate cancer-specific DFS, time to salvage anti-cancer therapy, and time to metastasis from the positive phase 3 clinical trial of CAN-2409 in patients with intermediate-to-high-risk localized prostate cancer after extended follow-up is expected in Q2 2026.
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The Company plans to initiate a pivotal phase 3 clinical trial of CAN-2409 in NSCLC in Q2 2026.
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Data on local and systemic biomarkers of immune activation from a mechanistic, supportive clinical trial of CAN-2409 in patients with localized prostate cancer, is expected in Q3 2026.
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The Company expects to present mature mOS data and an update on long-term survivors from arm C of its phase 1b clinical trial of CAN-3110 in patients with recurrent glioblastoma in Q4 2026.
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Submission of BLA for CAN-2409 in prostate cancer is expected in Q4 2026.

Financial Results for the Third Quarter Ended September 30, 2025

Research and Development Expenses: Research and development expenses were $8.5 million for the third quarter of 2025 compared to $5.4 million for the third quarter of 2024. The increase was primarily due to an increase in manufacturing and regulatory costs, in support of the Company’s CAN-2409 programs, and an increase in employee-related expenses, as well as an increase in depreciation and loss on the disposal and sale of fixed assets. Research and development expenses included a non-cash stock compensation expense of $0.5 million for the third quarter of 2025 compared to a non-cash stock compensation expense of $0.6 million for the third quarter of 2024.

General and Administrative Expenses: General and administrative expenses were $4.7 million for the third quarter of 2025, compared to $3.3 million for the third quarter of 2024. The increase was primarily due to an increase in commercial readiness costs as well as an increase in employee-related expenses. General and administrative expenses included non-cash stock compensation expense of $0.6 million for the third quarter of 2025 compared to $0.5 million for the third quarter of 2024.

Net Loss: Net loss for the third quarter of 2025 was $11.3 million compared to a net loss of $10.6 million for the third quarter of 2024 and included net other income of $1.9 million and net other expense of $1.9 million, respectively. The change from net other expense in 2024 to net other income in 2025 was primarily related to the change in the fair value of the Company’s warrant liability and an increase in interest income.

Cash Position: Cash and cash equivalents, as of September 30, 2025, were $87.0 million compared to $102.7 million as of December 31, 2024. Based on current operating plans, including the initiation of a potentially registrational phase 3 trial in NSCLC, the Company expects that its existing cash and cash equivalents, as of September 30, 2025, together with proceeds from the upfront tranche of the Trinity debt facility, will be sufficient to fund operations into Q1 2027.

About CAN-2409

CAN-2409 (aglatimagene besadenovec), Candel’s most advanced multimodal biological immunotherapy candidate, is an investigational, off-the-shelf, replication-defective adenovirus designed to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to a patient’s tumor. After intratumoral administration, HSV-tk enzyme activity results in conversion of prodrug (valacyclovir) into deoxyribonucleic acid (DNA)-incorporating nucleotide analogs, leading to immunogenic cell death in cells exhibiting DNA damage and proliferating cells, with subsequent release of a variety of tumor (neo)antigens in the tumor microenvironment. At the same time, the adenoviral serotype 5 capsid protein promotes inflammation through the induction of expression of pro-inflammatory cytokines, chemokines, and adhesion molecules. Together, this regimen is designed to induce an individualized and specific CD8+ T cell-mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity, based on in situ immunization against a variety of tumor antigens. CAN-2409 has the potential to treat a broad range of solid tumors. Encouraging monotherapy activity as well as combination activity with standard of care radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors have previously been shown in several preclinical and clinical settings. More than 1,000 patients have been dosed with CAN-2409 in clinical trials with a favorable tolerability profile to date, supporting the potential for combination with standard of care, when indicated.

About CAN-3110

CAN-3110 (linoserpaturev) is a first-in-class, replication-competent herpes simplex virus-1 (HSV-1) next-generation oncolytic viral immunotherapy candidate designed for dual activity for oncolysis and immune activation in a single therapeutic. In October 2023, the Company announced that Nature published results from the ongoing clinical trial where CAN-3110 was reported to be generally well tolerated with no dose-limiting toxicity. In the clinical trial, the investigators observed improved mOS compared to historical controls after a single CAN-3110 injection in this therapy-resistant condition.1 The Company and academic collaborators are currently supported by the Break Through Cancer foundation.

About the enLIGHTEN Discovery Platform

The enLIGHTEN Discovery Platform is a systematic, iterative HSV-based discovery platform leveraging human biology and advanced analytics to create new multimodal biological immunotherapies for solid tumors. The enLIGHTEN Discovery Platform has been designed to deconvolute the characteristics of the tumor microenvironment related to clinical outcomes. These characteristics are rapidly translated into optimized multi-gene payloads of tumor modulators that can be delivered to the tumor microenvironment for specific indications, disease stages, and rationally designed therapeutic combinations.

(Press release, Candel Therapeutics, NOV 13, 2025, View Source [SID1234659893])

On November 13, 2025 NuCana plc (NASDAQ: NCNA) ("NuCana" or the "Company") reported financial results for the third quarter ended September 30, 2025 and provided an update on its clinical development program with its two lead anti-cancer medicines.

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"We recently announced promising data for both NUC-7738 and NUC-3373 that continue to support the potential of our ProTides to deliver significantly improved treatment outcomes for patients with cancer," said Hugh S. Griffith, NuCana’s Chief Executive Officer. "For NUC-7738, we presented new data at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025 on NUC-7738 in combination with PD-1 inhibitors in a real-time organoid model system, which revealed that NUC-7738 enhances the effectiveness of PD-1 inhibitors, resulting in increased tumor cell killing. These data demonstrate the benefit of combining PD-1 inhibitors with NUC-7738, similar to that seen in patients on the ongoing NuTide:701 study. Based on the exciting initial data from this study, we are currently recruiting an additional 28 patients with PD-1 inhibitor-resistant melanoma and plan to meet with the U.S. Food and Drug Administration to discuss the data from this study to determine the optimal registration strategy to support potential marketing approval."

Mr. Griffith continued, "We also presented new clinical data from the NuTide:303 study, where encouraging signals of durable activity were observed in patients treated with NUC-3373 plus pembrolizumab who had exhausted all standard treatment options, including prior PD-1 inhibitors. Notably, one patient with melanoma remains progression-free at 23 months and continues to exhibit a partial response with an 81% reduction in target lesions. Another patient with urothelial carcinoma of the bladder achieved a 100% reduction in their target lesions and remained on treatment for over 15 months. These clinical findings are further supported by nonclinical data published in September 2025, which corroborate the immunogenic effects of NUC-3373 observed in patients, particularly in combination with a PD-1 inhibitor. We are currently evaluating optimal combinations and indications for further clinical studies of NUC-3373, while continuing to maintain our anticipated cash runway into 2029."

Mr. Griffith concluded, "Lastly, we have significantly strengthened our balance sheet via the strategic utilization of our at-the-market ("ATM") program in July, extending our cash runway into 2029 and through key value-driving milestones. This initiative, together with the financing in May, raised gross proceeds of $38.4 million, and with multiple data readouts ahead, we are well-positioned to deliver on our mission of improving treatment outcomes for patients with cancer."

Anticipated Milestones

NUC-7738

Announce initial data from the Phase 1/2 expansion study (NuTide:701) of NUC-7738 in combination with pembrolizumab in Q4 2025

Obtain regulatory guidance from the U.S. Food and Drug Administration on pivotal study design for NUC-7738 in melanoma in 2026; and

Announce final data from the Phase 1/2 expansion study (NuTide:701) of NUC-7738 in combination with pembrolizumab in 2026.

NUC-3373

Announce nonclinical data on further characterization of mode of action and target indications in 2026.

Third Quarter 2025 Financial Highlights and Cash Position

As of September 30, 2025, NuCana had cash and cash equivalents of £25.2 million compared to £8.4 million at June 30, 2025 and £6.7 million at December 31, 2024.

In July 2025, NuCana raised, through the ATM program, £19.0 million in gross proceeds before expenses and commission. On July 21, 2025, having raised the full amount of capital required, NuCana announced it had successfully canceled all remaining Series A Warrants issued in the May 2025 financing, in exchange for payments totaling $3.6 million. This initiative fully eliminated all overhanging rights from the May 2025 financing.

NuCana anticipates its cash and cash equivalents at September 30, 2025 will be sufficient to fund its planned operations into 2029.

NuCana reported a net loss of £0.3 million for the quarter ended September 30, 2025, which includes other income of £2.7 million, as compared to a net loss of £4.5 million for the quarter ended September 30, 2024. Basic and diluted loss per ordinary share was £0.00 for the quarter ended September 30, 2025, as compared to a loss per ordinary share of £0.07 for the comparable quarter ended September 30, 2024.

NuCana reported a net loss of £26.9 million for the nine months ended September 30, 2025, as compared to a net loss of £18.3 million for the nine months ended September 30, 2024. The net loss for the nine months ended September 30, 2025 included the following non-cash or non-recurring items:

Finance expense of £12.6 million (2024: £nil) relating to the non-cash loss on fair value revaluation of the warrants issued in the May 2025 financing;

Professional fees of £1.4 million (2024: £nil) related to the issue of warrants; and

Share-based payment expenses of £9.1 million (2024: £1.7 million); partly offset by

Other income of £2.7 million (2024: £nil).

Basic and diluted loss per ordinary share was £0.00 for the nine months ended September 30, 2025, as compared to a loss per ordinary share of £0.32 for the comparable nine months ended September 30, 2024.

(Press release, Nucana, NOV 13, 2025, View Source [SID1234659909])

On November 13, 2025 TriSalus Life Sciences, Inc. (Nasdaq: TLSI) (the "Company"), an oncology company integrating novel delivery technology with standard of care therapies, and its investigational immunotherapeutic to transform treatment for patients with solid tumors, reported financial results for the quarter ended September 30, 2025, and provides an operation update.

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"TriSalus continued to deliver strong commercial performance in the third quarter, underscoring the growing clinical adoption of our TriNav product suite and proprietary PEDD platform across a broad range of solid tumor indications," said Mary Szela, President and CEO of TriSalus. "We are pleased to reaffirm our full-year revenue growth guidance of 50%, reflecting the increasing market penetration of TriNav for liver-directed therapies. We continue to invest in registry and other clinical programs and are committed to building a data-driven case for the expansion of our PEDD technology platform to new embolization applications. With our strategic shift toward partnering development of nelitolimod, we are also reducing our quarterly cash burn even as we extend our platform. Our three PERIO clinical phase 1 dose escalation studies are completed, with clinical study reports under preparation for data release in Q4. We look forward to the balance of 2025 energized by our long-term vision of bringing our PEDD technology to a wider range of patients and improving their clinical outcomes."

Third Quarter 2025 Operational Highlights

Generated $11.6 million in net sales, a 57% increase year-over-year, and sequential growth of 3% over the second quarter 2025.
Lowered quarterly cash burn by approximately 50% quarter-over-quarter.
Delivered strong commercial performance, with expanding use of TriNav in liver embolization, and continued further development of new applications for new clinical settings focused on the interventional radiology call point.
Simplified the Company’s capital structure through successful completion of an exchange offering of previously issued Series A Preferred stock.
Investigator-published study in the Journal of the Endocrine Society includes results of a retrospective single-center study by Gad et al. which evaluated the safety, feasibility, and early efficacy of Pressure-Enabled Thyroid Artery Embolization (PED-TAE) using the TriNav Infusion System. This novel, minimally invasive technique targets the inferior thyroid arteries to reduce gland size and alleviate symptoms in patients who are not candidates for surgery or conventional therapies. These early results lay the foundation for a broader evaluation of pressure-enabled embolization in the management of benign thyroid disease,"
Initiated a clinical trial to evaluate genicular artery embolization (GAE) as a potential treatment for knee osteoarthritis, a condition affecting more than 30 million adults in the United States. The study aims to assess whether GAE can reduce pain and delay the need for knee replacement surgery.
Third Quarter 2025 Financial Results

Revenue, all from sales of the TriNav system, was $11.6 million for the three months ended September 30, 2025, an increase of 57% compared to the same period in 2024 and 3% sequential growth. Revenue growth was driven primarily by increased TriNav sales within liver directed applications.
Gross margins were 84% in the third quarter, compared to 86% in the same period of 2024. The year-over-year decline was primarily driven by lower manufacturing efficiency associated with newly launched products, a dynamic we continue to expect to improve as production scales and processes mature over the course of the year.
Research and Development (R&D) expenses were approximately $5.2 million, compared to $4.2 million for the same quarter of the prior year. The increase was primarily due to a one-time charge of approximately $2.1 million related to closing of our clinical studies related to nelitolimod, partially offset by the revision of approximately $0.7 million in patent-related costs to general and administrative expenses.
Sales and Marketing (S&M) expenses were approximately $6.8 million in the third quarter, compared to $6.1 million for the same quarter of the prior year. The year-over-year increase was primarily due to an increase in performance related compensation driven by the increase in sales.
General & Administrative (G&A) expenses for the third quarter were approximately $6.7 million, compared to $4.7 million for the same quarter of the prior year. The increase was primarily driven by the acceleration of approximately $1.6 million in non-cash stock-based compensation and the revision of approximately $0.7 million in patent-related expenses from research and development to general and administrative.
Operating losses were $9.0 million, compared to Operating losses of $8.7 million for the same period in the prior year. The increase was primarily driven by a one-time charge related to the close out of our clinical studies along with a one-time acceleration of non-cash stock based compensation related awards.
Net loss attributable to common stockholders was $41.3 million in the third quarter, compared to $3.2 million for the same period in the prior year, primarily driven by the conversion of our preferred stock to common stock during the third quarter of 2025, resulting in approximately $30.5 million net loss attributable to common stockholders.
The basic and diluted loss per share was $0.96 for the third quarter, compared to $0.12 for the same period in 2024. This is primarily due to the conversion of preferred stock to common stock.
As of September 30, 2025, cash and cash equivalents totaled $22.7 million providing sufficient runway to reach positive adjusted EBITDA.
The non-GAAP measure of adjusted EBITDA is reconciled in the table below as the Company believes it is an important measure of performance. Adjusted EBITDA losses were $5.4 million, compared to losses of $7.2 million for the same period in 2024. Adjusted EBITDA for the period includes approximately $2.1 million of a charge related to closing the clinical studies related to Nelitolimod. Currently, reductions in adjusted EBITDA losses are due to increased sales, reduced research and development expenses and increased stock compensation in 2025.

Conference Call

The Company will host a conference call and webcast today, November 13, 2025 at 4:30 PM eastern time to discuss its financial results for the quarter ended September 30, 2025. Parties interested in participating by phone should register using this online form. After registering for the webcast, dial-in details will be provided in an auto-generated e-mail containing a link to the conference phone number along with a personal pin. The event will also be webcast live on the investor relations section of TriSalus’ website. A replay will also be available on the website following the event.

(Press release, TriSalus Life Sciences, NOV 13, 2025, View Source [SID1234659938])

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])

On November 13, 2025 Omeros Corporation (Nasdaq: OMER) reported recent highlights and developments as well as financial results for the third quarter ended September 30, 2025, which include:

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● Net loss for the third quarter of 2025 was $30.9 million, or $0.47 per share, compared to a net loss of $32.2 million, or $0.56 per share for the third quarter of 2024. For the nine months ended September 30, 2025, our net loss was $89.8 million, or $1.47 per share, compared to a net loss of $125.5 million, or $2.15 per share in the corresponding prior year period. Non-GAAP adjusted net loss for the three months and nine months ended September 30, 2025 was $22.1 million, or $0.34 per share, and $89.1 million, or $1.46 per share. Non-GAAP adjusted net loss excludes a non-cash charge for the change in the estimated fair value of embedded derivatives on our current term loan and convertible debt facilities.

● At September 30, 2025, we had $36.1 million of cash and short-term investments. As previously announced, on July 28, 2025, we issued and sold 5,365,853 shares of our common stock in a registered direct offering to entities managed by Polar Asset Management Partners (collectively, "Polar") at a price of $4.10 per share, representing a 14% premium to the closing price of our common stock on the date of the purchase agreement. We received $20.3 million in cash proceeds, net of offering expenses. Also, during the three months ended September 30, 2025, we sold 2.3 million shares of common stock pursuant to our at-the-market offering facility, generating net proceeds of $9.0 million.

● Cash burn during the third quarter of 2025, exclusive of any financing proceeds, was $22.0 million.

● On October 10, 2025, we entered into an Asset Purchase and License Agreement (the "APLA") with Novo Nordisk Health Care AG ("Novo Nordisk"). Closing of the transaction is subject to the satisfaction or waiver of certain customary closing conditions and is expected to occur in the fourth quarter of 2025. Pursuant to the APLA, Novo Nordisk will receive exclusive global rights in all indications to develop and commercialize zaltenibart (OMS906), our lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-3 ("MASP-3"), certain related monoclonal antibodies and antigen-binding fragments, and related pharmaceutical products. In exchange, we will receive up to an aggregate of $2.1 billion in upfront and milestone-based payments plus tiered royalties on global net sales. Specifically, we will receive an upfront cash payment of $240 million to be paid upon closing and are eligible for:

● An additional $100.0 million in near-term milestone payments;

● Up to $410.0 million more in one-time milestone payments upon the first achievement of certain development and approval milestone events to be achieved by Novo Nordisk;

● Up to $1.3 billion in one-time milestone payments upon the achievement by Novo Nordisk of certain sales-based and commercial milestone events; plus

● Tiered royalties on annual global net sales of applicable products at rates ranging from a high single-digit to high-teens.

The upfront cash of $240.0 million payable at closing, together with cash on hand, is expected to provide sufficient capital to (i) fund the repayment at the closing of all outstanding obligations under our senior secured credit agreement, including $67.1 million in outstanding term loan principal, a related prepayment premium, accrued and unpaid interest, and expenses; (ii) allow for repayment at or prior to maturity in February 2026 of the $17.1 million remaining principal balance of our 2026 convertible notes; and (iii) provide capital for more than 12 months of post-closing operations, including the anticipated U.S. launch of narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy ("TA-TMA").

● As previously disclosed, in March 2025, we resubmitted to the U.S. Food and Drug Administration ("FDA") our Biologics License Application ("BLA") seeking regulatory approval for narsoplimab, our lead monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 ("MASP-2"), for the treatment of TA-TMA. Pursuant to the Prescription Drug User Fee Act ("PDUFA"), the class 2 resubmission was assigned September 25, 2025 as the target action date. Following a comprehensive response to an FDA information request, the Agency extended the PDUFA date to December 26, 2025. We expect that FDA will meet this PDUFA date. All analyses requested by FDA as part of its review have been consistent with and have provided statistically significant support of narsoplimab’s benefit demonstrated in the analyses submitted as part of the BLA resubmission.

● In June 2025, we submitted our marketing authorization application ("MAA") for narsoplimab in TA-TMA to the European Medicines Agency ("EMA"). EMA has completed validation of the MAA, confirming the acceptance of the submission and starting the formal review process by EMA’s Committee for Medicinal Products for Human Use. We expect the committee to render its opinion on the MAA in mid-2026.

"Our team delivered a series of accomplishments in the third quarter that I believe position Omeros for a potentially transformative period ahead," said Gregory A. Demopulos, M.D., Omeros’ Chairman and Chief Executive Officer. "The crucial above-market financing completed in July, the development of the Novo Nordisk transaction expected to close before year-end, and FDA’s fast-approaching decision on approval for narsoplimab in TA-TMA – each of these strategic components was set in motion and consummated or greatly solidified during the quarter. Together, they could well provide the financial strength and operational flexibility to accelerate significantly the development across our first-in-class pipeline programs, including our long-acting MASP-2 inhibitor OMS1029, our PDE7 inhibitor OMS527 for the treatment of addictions and compulsions, our T-CAT program targeting multidrug-resistant pathogens, and our oncology therapeutic platform. Success in any one of these programs could deliver significant clinical benefit to our patients and substantial value to our shareholders. In the near term, we look forward to the closing of the Novo Nordisk transaction and, importantly, to FDA’s decision and the planned commercial launch of narsoplimab."

Third Quarter and Recent Developments

● Recent developments regarding narsoplimab, our lead monoclonal antibody targeting MASP-2, include the following:

● In anticipation of the potential approval of narsoplimab in TA-TMA, our U.S. commercial organization is assembled and launch-ready, including the first wave of our sales force, all of whom have extensive experience in hematology and transplant centers.

● Engagements with decision makers at transplant centers, hospitals, and payers through pre-approval information exchanges have been consistently encouraging, with rapid recognition of narsoplimab’s favorable benefit-risk profile and dosing regimen in TA-TMA.

● Following anticipated approval for treatment of TA-TMA, narsoplimab will be marketed under the brand name YARTEMLEA.

● We have established a national ICD-10 diagnostic code specific to TA-TMA and an associated CPT procedural code specifically for narsoplimab, together positioning narsoplimab, once approved, as the only reimbursable TA-TMA treatment. We also expect to receive a New Technology Add-On Payment ("NTAP") under Medicare to support hospital reimbursement.

● Two peer-reviewed manuscripts detailing narsoplimab’s safety and survival benefits in high-risk TA-TMA patients were recently published in premier journals:

o "Survival in Adults with High Risk TA-TMA—A Comparative Analysis of Narsoplimab Versus Supportive Care," published in Blood Advances, highlights survival benefits with narsoplimab in TA-TMA patients (both pivotal clinical trial and global expanded access program participants) versus a well-matched external control group receiving standard of care.

o "Narsoplimab Results in Excellent Survival in Adults and Children with Hematopoietic Cell Transplant Associated Thrombotic Microangiopathy (TA-TMA)," published in the American Journal of Hematology, reports survival outcomes in patients treated, under our expanded access program, with narsoplimab either as first-line therapy or as salvage treatment in those who failed prior regimens with other complement agents including C5 inhibitors, and/or defibrotide.

In both published studies, and consistent with previous narsoplimab clinical studies, no safety signals of concern were observed.

● Recent developments in other programs include the following:

● We were previously awarded a three-year, $6.24 million grant from the National Institute on Drug Abuse ("NIDA"), part of the National Institutes of Health, to develop, at NIDA’s request, our lead orally administered phosphodiesterase 7 ("PDE7") inhibitor for the treatment of cocaine use disorder. The grant is intended to support (i) preclinical cocaine interaction/toxicology studies to assess safety of the therapeutic candidate in the presence of concomitant cocaine administration and (ii) an in-patient, placebo-controlled clinical study evaluating the safety and effectiveness of OMS527 in adult cocaine users who receive concurrent intravenous cocaine. The preclinical studies, designed with NIDA toxicologists, were completed with no safety findings and provide drug-interaction safety data in support of the planned in-patient human study of OMS527 in cocaine users. FDA has requested that the Company provide additional preclinical information prior to initiating the clinical in-patient study in cocaine users, which we target for the second half of 2026.

● We have continued to advance IND-enabling work in our OncotoX biologics program focused first on acute myeloid leukemia ("AML").

o OncotoX-AML shows broad application across AML regardless of genetic mutation including TP53, NPM1, KMT2A, and FLT3.

o Human tumor-bearing animal and in vitro human AML cell-line studies show superior efficacy of our OncotoX-AML to standard of care. Results to date from an ongoing safety study in non-human primates are encouraging.

o With the assistance and guidance of our Oncology Clinical Steering Committee, composed of leaders in AML treatment and research at premier cancer centers across the United States, we estimate that our OncotoX-AML therapeutic could enter the clinic in 18-24 months.

● Our Targeted Complement Activating Therapy ("T-CAT") platform – a new class of pathogen-targeting recombinant antibodies designed to target and directly kill bacteria, fungi, viruses, and parasites – continues to amass animal data across multiple pathogen classes and species. Our initial focus is on multidrug-resistant organisms ("MDROs"), widely recognized as one of the most critical unmet needs in medicine.

Financial Results

Net loss for the third quarter of 2025 was $30.9 million, or $0.47 per share, compared to a net loss of $32.2 million, or $0.56 per share for the third quarter of 2024. For the nine months ended September 30, 2025, our net loss was $89.8 million, or $1.47 per share, compared to a net loss of $125.5 million, or $2.15 per share in the prior year period. The reduction in net loss from the prior year was primarily due to incurring narsoplimab drug substance manufacturing expense in the prior year period. In addition, we reduced expenditures on our various programs in the current quarter in an ongoing effort to conserve capital in anticipation of our expected commercial launch of narsoplimab in TA-TMA. Non-GAAP adjusted net loss for the three months and nine months ended September 30, 2025 was $22.1 million, or $0.34 per share, and $89.1 million, or $1.46 per share. Non-GAAP adjusted net loss excludes a non-cash charge for the change in the estimated fair value of embedded derivatives on our current term loan and convertible debt facilities.

At September 30, 2025, we had $36.1 million of cash and short-term investments. Pursuant to a covenant in our Credit and Guaranty Agreement, dated June 3, 2024, we must maintain $25.0 million of unrestricted cash, cash equivalents, and short-term investments at all times. On July 28, 2025, we issued and sold in a registered direct offering to entities managed by Polar 5,365,853 shares of our common stock at a price of $4.10 per share, representing a 14% premium to the closing price of our common stock on the day of pricing. We received $20.3 million in cash proceeds, net of offering expenses.

We have an at-the-market equity offering facility through which we may, from time to time, offer and sell shares of our common stock for aggregate gross proceeds of up to $150.0 million (the "ATM Facility"). During the three months ended September 30, 2025, we sold 2.3 million shares of common stock pursuant to our ATM program, generating net proceeds of $9.0 million. Subsequent to September 30, 2025 and through November 12, 2025, we have received an additional $3.6 million in net proceeds from sales of common stock through the ATM Facility.

Cash burn during the third quarter of 2025, exclusive of any financing proceeds, was $22.0 million.

For the third quarter of 2025, we earned OMIDRIA royalties of $9.2 million from Rayner Surgical Inc. on U.S. net sales of $30.5 million. This compares to earned OMIDRIA royalties of $9.3 million during the third quarter of 2024 on U.S. net sales of $31.0 million. Per the terms of our original 2022 and amended 2024 agreements with DRI Health Acquisition LP, ("DRI"), all U.S.-based royalties through 2031 are remitted from Rayner to DRI through an escrow agent.

Total operating expenses for the third quarter of 2025 were $26.4 million compared to $35.4 million during the third quarter of 2024. The $9.0 million decrease was primarily driven by a temporary pause in spending on certain activities to prioritize available capital to support the commercial launch of narsoplimab following its anticipated FDA approval.

Interest expense during the third quarter was a credit of $13.4 million compared to $4.1 million during the prior year quarter. The $17.5 million decrease was primarily due to a non-cash remeasurement adjustment of $22.3 million on our OMIDRIA royalty obligation to DRI to reflect changes in the royalty forecast from Rayner.

During the third quarter of 2025, we earned $0.6 million in interest and other income compared to $2.3 million in the third quarter of 2024. The difference is primarily due to lower cash and investments available to invest in the current quarter.

Net loss from discontinued operations, net of tax, was $9.7 million, or $0.15 net loss per share, in the third quarter of 2025 compared to net income from discontinued operations, net of tax of $4.9 million, or $0.08 net income per share, in the third quarter of 2024. The decrease was primarily attributable to a non-cash remeasurement of our OMIDRIA contract royalty asset in the current quarter reflecting changes in royalty estimates from Rayner.

Conference Call Details

Omeros’ management will host a conference call and webcast to discuss the financial results and to provide an update on business activities. The call will be held today at 1:30 p.m. Pacific Time; 4:30 p.m. Eastern Time.

For online access to the live webcast of the conference call, go to Omeros’ website at View Source

To access the live conference call via phone, participants must register at the following URL View Source to receive a unique PIN. Once registered, you will have two options: (1) dial in to the conference line provided at the registration site using the PIN provided to you, or (2) choose the "Call Me" option, which will instantly dial the phone number you provide. Should you lose your PIN or registration confirmation email, simply re-register to receive a new PIN.

A replay of the call will be made accessible online at View Source

(Press release, Omeros, NOV 13, 2025, View Source [SID1234659910])