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])

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
•
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.

•
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).
•
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.
•
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.
•
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.
•
CAN-3110 (linoserpaturev) – Recurrent High-Grade Glioma (rHGG)

•
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).
•
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).
•
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.

•
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.
•
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

•
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.
•
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.
•
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.
•
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.
•
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])