NuCana Reports Second Quarter 2026 Financial Results and Provides Business Update

On August 13, 2026 NuCana plc (NASDAQ: NCNA) ("NuCana" or the "Company") reported financial results for the second quarter ended June 30, 2026 and provided an update on its clinical development program with its two lead anti-cancer medicines.

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"NuCana continues to build momentum as we advance NUC-7738 closer to several important clinical and regulatory milestones," said Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer. "We are pleased to announce that recruitment is now complete in our Phase 2 NuTide:701 expansion study evaluating NUC-7738 in combination with Keytruda (pembrolizumab) in patients with PD-1 inhibitor-resistant metastatic melanoma. Based on the data presented to date, we remain confident in the benefit NUC-7738 may offer these patients, and we remain on track to present final data from this study later this year. Following the Investigational New Drug application ("IND") clearance from the U.S. Food and Drug Administration (the "FDA") earlier this year, we look forward to continuing our dialogue with the FDA to determine the optimal path toward a potential registrational strategy for NUC-7738 in melanoma."

Mr. Griffith continued, "We believe NUC-7738’s ability to disrupt RNA polyadenylation and act on multiple aspects of the tumor microenvironment could make an impact across a broad range of tumor types. The Company continues to assess potential additional indications, subject to emerging data and portfolio prioritization."

Mr. Griffith concluded, "None of this progress would be possible without a strong financial foundation. With cash resources anticipated to fund our operations into 2029, we have the flexibility to keep advancing our pipeline, including evaluating additional indications and combination strategies for NUC-7738 and NUC-3373. We look forward to delivering on our milestones over the remainder of 2026."

2026 Anticipated Milestones

NUC-7738

Complete patient recruitment in the Phase 2 expansion study (NuTide:701) evaluating NUC-7738 in combination with pembrolizumab in patients with PD-1 inhibitor-resistant melanoma;
Announce final data from the Phase 2 expansion study (NuTide:701) of NUC-7738 in combination with pembrolizumab in patients with PD-1 inhibitor-resistant melanoma;
Obtain regulatory guidance from the FDA regarding a potential registrational strategy for NUC-7738 in melanoma; and
Advance evaluation of additional indications and combination strategies.
NUC-3373

Complete evaluation of optimal combinations and indications to inform potential future clinical studies of NUC-3373.
Second Quarter 2026 Financial Highlights and Cash Position

As at June 30, 2026, NuCana had cash and cash equivalents of £19.5 million compared to £21.5 million at March 31, 2026 and £24.3 million at December 31, 2025. NuCana anticipates its cash and cash equivalents at June 30, 2026 will be sufficient to fund its planned operations into 2029.

NuCana reported a net loss of £3.1 million for the quarter ended June 30, 2026, as compared to a net loss of £24.1 million for the quarter ended June 30, 2025. Basic and diluted loss per ordinary share was £0.00 for the quarter ended June 30, 2026, as compared to a loss per ordinary share of £0.00 for the comparable quarter ended June 30, 2025.

NuCana reported a net loss of £6.9 million for the six months ended June 30, 2026, as compared to a net loss of £26.6 million for the six months ended June 30, 2025. The net loss for the six months ended June 30, 2026 and for the comparable period included the following non-cash or non-recurring items:

Share-based payment expenses of £2.8 million (2025: £8.2 million);
Professional fees of £nil (2025: £1.4 million) related to the issue of warrants; and
Finance expense of £nil (2025: £12.6 million) relating to the non-cash loss on fair value revaluation of the warrants issued in the May 2025 financing.
Basic and diluted loss per ordinary share was £0.00 for the six months ended June 30, 2026, as compared to a loss per ordinary share of £0.01 for the comparable six months ended June 30, 2025.

(Press release, Nucana, AUG 13, 2026, View Source [SID1234670097])

Candel Therapeutics Reports Second Quarter 2026 Financial Results and Recent Corporate Highlights

On August 13, 2026 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal immunotherapies to improve outcomes for patients with cancer, reported financial results for the second quarter ended June 30, 2026, and provided a corporate update.

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"This quarter reflects meaningful execution across the company as we advance aglatimagene toward a planned BLA submission in the fourth quarter of 2026 and continue to build the foundation for a potential U.S. commercial launch in localized prostate cancer," said Paul Peter Tak, M.D., Ph.D., FMedSci, President and CEO of Candel. "We believe the extended follow-up data presented at AUA, together with the publication of our pivotal phase 3 results in The Lancet Oncology, further reinforce the potential of aglatimagene to address an important unmet need for patients with intermediate- to high-risk localized prostate cancer. At the same time, the activation of the first trial site for the AURORA phase 3 clinical trial in patients with advanced NSCLC underscores the broader potential of our multimodal immunotherapy platform across solid tumors."

Dr. Tak continued, "We also made important progress in commercial readiness through our appointment of Mark Sims as Chief Commercial Officer, adding deep oncology commercialization and launch experience as we prepare for the next stage of Candel’s growth. With a strong balance sheet, we believe we are well-positioned to execute our operating plan into the first quarter of 2028, including activities intended to support a potential U.S. commercial launch of aglatimagene in 2027, if approved."

Second Quarter 2026 & Recent Highlights


Aglatimagene besadenovec – Prostate Cancer

The Company continues to advance its pre-BLA readiness initiative, including its Chemistry, Manufacturing, and Controls (CMC) activities, preparation of clinical study reports, and BLA modules.

Process validation campaign for drug substance and drug product is being executed at our contract development and manufacturing organization. The campaign is progressing well and is a critical CMC activity to enable the anticipated BLA submission in Q4 2026.

New clinical material has been produced and is intended to be used in the pivotal phase 3 clinical trial of aglatimagene in NSCLC.

The Company published results from the randomized, double-blind, placebo-controlled, multicenter pivotal phase 3 clinical trial of aglatimagene in patients with intermediate- to high-risk localized prostate cancer in The Lancet Oncology. These data were initially announced in December 2024 and presented as an oral presentation at ASCO (Free ASCO Whitepaper) 2025.


The Company presented clinical data from extended follow-up of its phase 3 trial of aglatimagene in prostate cancer in a plenary oral presentation at the AUA 2026 Annual Meeting, held in Washington, D.C. from May 15-18, 2026.

Among the 745 patients enrolled in the randomized, double-blind, placebo-controlled trial, the aglatimagene arm exhibited a 39% improvement in prostate cancer-specific disease-free survival (PCa-specific DFS) compared to placebo after a median follow-up of 58 months (data as of March 15, 2026).

The Company observed consistently favorable trends in both the intent to treat and intermediate-risk subgroup populations across all secondary and exploratory endpoints, including time to biochemical failure, time to metastasis, rate of metastasis, and time to salvage anti-cancer therapy (time to new treatment), when comparing the aglatimagene arm with placebo, on top of standard-of-care radiotherapy.

There were no new safety signals or additional toxicities observed.
For additional information, please refer to Candel’s May 15, 2026, press release.


The Company will present an abstract delineating extended biomarker analysis from the phase 3 clinical trial of aglatimagene in patients with localized prostate cancer at the 2026 American Society for Radiation Oncology (ASTRO) Annual Meeting in Q3 2026.

The U.S. Food and Drug Administration (FDA) previously granted Fast Track Designation and Regenerative Medicine Advanced Therapy Designation to aglatimagene for the treatment of localized prostate cancer. The phase 3 clinical trial of aglatimagene in localized prostate cancer was conducted under a Special Protocol Assessment with respect to certain aspects of the study design, agreed with the FDA.

Aglatimagene besadenovec – Non-Small Cell Lung Cancer (NSCLC)

In June 2026, the Company activated the first clinical trial site of the global pivotal phase 3 clinical trial (AURORA) (NCT07660094), which will evaluate aglatimagene plus valacyclovir in combination with continued pembrolizumab in patients with metastatic non-squamous NSCLC whose disease has progressed despite treatment with pembrolizumab and platinum-based chemotherapy.

The randomized, open-label AURORA trial is expected to enroll patients with metastatic stage IV non-squamous NSCLC across approximately 150 sites worldwide, randomized 1:1 to receive either two courses of aglatimagene plus valacyclovir with continued pembrolizumab or standard-of-care docetaxel chemotherapy.

The study’s primary endpoint is overall survival, with secondary endpoints including safety and quality-of-life assessments (NSCLC-SAQ and EORTC QLQ-30).

The FDA previously granted Fast Track Designation to aglatimagene for the treatment of NSCLC.

Linoserpaturev – Recurrent Glioblastoma (rGBM)

Following FDA clearance of its Investigational New Drug application for linoserpaturev in Q1 2026, the Company is advancing next-stage development planning for rGBM.

Enabling work is underway to support a potential randomized phase 2 dose-regimen-finding study.

The clinical trial is expected to inform the optimal number of linoserpaturev administrations and a recommended regimen for future development.

Recent Corporate Events

In June 2026, the Company appointed Mark Sims as Chief Commercial Officer. Mr. Sims is a seasoned oncology commercial leader with more than 25 years of experience building and advancing Global and U.S. cancer franchises. He held key leadership roles at AstraZeneca PLC, Novartis AG, and Idenix Pharmaceuticals, Inc.. Mr. Sims’ appointment strengthens the Company’s efforts toward its planned BLA submission in the fourth quarter of 2026 and potential 2027 launch of aglatimagene in localized prostate cancer.

In April 2026, the Company announced a commercialization agreement with EVERSANA to support the potential U.S. launch of aglatimagene in localized prostate cancer. This operating model gives Candel immediate access to leading commercial capabilities, while maintaining financial flexibility, capital efficiency, and scientific focus that has driven the Company’s progress to date.
Anticipated Milestones


Abstract showcasing extended biomarker data from the phase 3 clinical trial of aglatimagene in patients with localized prostate cancer to be presented as a poster at the ASTRO Annual Meeting in Q3 2026.

The Company expects to present potential long-term survival data from arm C of its phase 1b clinical trial of linoserpaturev in patients with recurrent high-grade glioma (rHGG) in Q4 2026.


Submission of a BLA for aglatimagene in prostate cancer is planned for Q4 2026.

Financial Results for the Second Quarter Ended June 30, 2026

Research and Development Expenses: Research and development expenses were $19.8 million for the second quarter of 2026 compared to $7.0 million for the second quarter of 2025. The increase was primarily due to higher clinical trial and manufacturing costs, in support of the Company’s aglatimagene programs, and an increase in employee-related expenses. Research and development expenses included a non-cash stock compensation expense of $1.8 million for the second quarter of 2026, as compared to a non-cash stock compensation expense of $0.4 million for the second quarter of 2025.

General and Administrative Expenses: General and administrative expenses were $6.9 million for the second quarter of 2026, compared to $4.2 million for the second quarter of 2025. The increase was primarily due to higher commercial readiness costs and an increase in employee-related expenses. General and administrative expenses included non-cash stock compensation expense of $1.0 million for the second quarter of 2026, as compared to a non-cash stock compensation expense of $0.6 million for the second quarter of 2025.

Net Income/Loss: Net loss for the second quarter of 2026 was $38.9 million compared to net loss of $4.8 million for the second quarter of 2025 and included net other expense of $12.2 million and net other income of $6.4 million, respectively. The increase in net other expense was primarily related to the change in the fair value of the Company’s warrant liabilities.

Cash Position: Cash and cash equivalents, as of June 30, 2026, were $201.6 million compared to $119.7 million as of December 31, 2025. Based on current operating plans, the Company expects that its existing cash and cash equivalents, as of June 30, 2026, will be sufficient to fund operations into Q1 2028.

About aglatimagene besadenovec

Aglatimagene, 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 proteins promote 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 varietyof tumor antigens. Aglatimagene 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 aglatimagene in clinical trials with a favorable tolerability profile to date, supporting the potential for use with standard of care, when indicated. Aglatimagene is currently not approved by the FDA or any other regulatory authority for any use.

About linoserpaturev

Linoserpaturev is a first-in-class, replication-competent, next-generation oncolytic herpes simplex virus-1 (HSV-1) 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 linoserpaturev was reported to be generally well tolerated with no dose-limiting toxicity. In the clinical trial, the investigators observed improved median overall survival compared to historical controls after a single linoserpaturev injection in this therapy-resistant condition1. The Company and academic collaborators are currently supported by the Break Through Cancer foundation to evaluate the effects of repeated linoserpaturev injections in patients with recurrent glioblastoma in an expansion cohort from the phase 1b clinical trial. In October 2025, Science Translational Medicine presented findings from the comprehensive analysis of 97 serial tumor biopsies collected from two patients treated with repeated administrations of linoserpaturev in arm C. Linoserpaturev previously received Fast Track Designation and Orphan Drug Designation for the treatment of rHGG from the U.S. Food and Drug Administration (FDA).

(Press release, Candel Therapeutics, AUG 13, 2026, View Source [SID1234670061])

Tempest Reports Second Quarter 2026 Financial Results and Provides Business Update

On August 13, 2026 Tempest Therapeutics, Inc. (Nasdaq: TPST) ("Tempest"), a clinical-stage biotechnology company developing a pipeline of advanced chimeric antigen receptor T-cell ("CAR-T") product candidates, reported financial results for the quarter ended June 30, 2026, and provided a business update.

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"We continue to execute against our strategy by advancing our next-generation in vivo CAR-T platform, expanding our expertise with the appointment of two new board members and strengthening our development capabilities through a new collaboration focused on our next-generation in vivo CAR-T candidate, TPST-4003," said Matt Angel, Ph.D., President and Chief Executive Officer of Tempest. "These milestones reflect the momentum we are building across the business and reinforce our commitment to developing innovative therapies aiming to transform patient care. We are particularly excited to advance TPST-4003 toward an investigator-initiated clinical trial planned for the fourth quarter of 2026, an important step as we work to bring transformative options to patients."

Recent Highlights

TPST-4003
Unveiled next-generation in vivo CAR-T pipeline, including lead product candidate TPST-4003, a dual-targeting CD19/BCMA CAR-T that combines the company’s proprietary CD7-targeted mRNA/LNP delivery with its clinically validated dual-target CAR architecture for broad B-cell lineage depletion and reset.
Executed a strategic partnership with Hebei Senlang Biotechnology to collaborate on the development of Tempest’s certain proprietary in vivo CAR-T product candidates, including its CD7-targeted next-generation in vivo CAR-T product candidate, TPST-4003, beginning with an investigator-initiated trial in China evaluating TPST-4003 in approximately 10 patients with myasthenia gravis or multiple sclerosis. The company expects first patient enrollment and dosing to occur in the fourth quarter of 2026.

TPST-2003

Reported positive interim results across two ongoing clinical trials (REDEEM-1 Phase 1/2a trial of TPST-2003 in patients with relapsed/refractory multiple myeloma ("rrMM"), and POEMS-1 Phase 1 trial evaluating TPST-2003 in the rare disease, POEMS syndrome), both of which are being sponsored and conducted by Tempest’s partner, Novatim Immune Therapeutics:
100% complete response rate among all 15 CAR-T-naïve efficacy evaluable patients treated with TPST-2003 across REDEEM-1 and POEMS-1 trials.
Favorable safety profile with no Grade ≥3 cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome in REDEEM-1 trial appears to be emerging as a potentially differentiating attribute in its class.
Prior investigator-initiated trial reached median progression free survival of 23.1 months, including in patients with extramedullary disease.
44 patients with rrMM treated to date across three studies.

Announced the selection of Cincinnati Children’s AGCTC as the lead contract development and manufacturing partner to conduct the formal technology transfer of TPST-2003, Tempest’s dual-targeting CD19/BCMA CAR-T therapy under development for the treatment of relapsed/refractory multiple myeloma (rrMM). Further to the selection of AGCTC as lead partner, AGCTC took delivery of the TPST-2003 lentiviral vector, a critical component used in the manufacturing of TPST-2003, supporting plans to initiate the first potentially registrational study to evaluate a dual-targeting CAR-T therapy in patients with rrMM, including patients who are experiencing extramedullary disease (EMD), later this year.

Corporate:

Entered into a definitive agreement for the inducement of exercise of certain outstanding warrants ("Warrant Inducement") for approximately $2.0 million in gross proceeds.
Appointed two independent directors, Drake Richey and John Yee, MD, MPH, collectively bringing decades of experience in corporate finance and therapeutic product development to Tempest’s Board of Directors.
Announced the appointment of Andrew Fang, Ph.D., as Head of Business Development. In his role, Dr. Fang will lead Tempest’s global business development efforts, including strategic partnerships, cross-border licensing and corporate transactions, with a particular focus on expanding Tempest’s outreach and partnering efforts in China.

Financial Results

Second Quarter 2026

Tempest ended the quarter with $0.8 million in cash and cash equivalents, compared to $7.7 million on December 31, 2025. The decrease was primarily due to one-time transaction-associated costs incurred prior to or upon closing of the Asset Acquisition in February 2026, offset by the net proceeds of the Company’s private placement of common stock and warrants in March 2026 of $1.7 million and the Warrant Inducement of $1.7 million in the second quarter.
Net loss and net loss per share for the quarter were $5.2 million and $0.34, respectively, compared to $7.9 million and $2.07, respectively, for the three months ended June 30, 2025.
Research and development expenses for the quarter were $1.8 million compared to $3.9 million for the three months ended June 30, 2025. The $2.1 million decrease was primarily due to a decrease in costs incurred as a result of the re-prioritization of efforts after the Asset Acquisition in February 2026, offset by research and manufacturing costs related to the Company’s CAR-T product candidates.
General and administrative expenses for the quarter were $3.4 million compared to $4.1 million for the same period in 2025. The $0.7 million decrease was primarily due to a decrease in one-time separation costs previously incurred in the second quarter of 2025, offset by other administrative expenses.

Year-to-Date

Cash used in operating activities for the six months ended June 30, 2026 was $10.4 million.
Net loss and net loss per share for the six months ended June 30, 2026 were $32.9 million and $2.52, respectively, compared to $18.7 million and $5.17, respectively, for the same period in 2025.
Research and development expenses for the six months ended June 30, 2026 were $1.9 million, compared to $11.5 million for the same period in 2025. The $9.6 million decrease was primarily due to a decrease in costs incurred as a result of re-prioritizing efforts towards exploring strategic alternatives initiated in April 2025 and resulting in the Asset Acquisition completed in February 2026.
General and administrative expenses for the six months ended June 30, 2026 were $8.9 million, compared to $7.4 million for the same period in 2025. The $1.5 million increase was primarily due to one-time costs resulting from the Asset Acquisition completed in February 2026.
Acquired in-process research and development expenses for the six months ended June 30, 2026 were $22.1 million compared to nil for the six months ended June 30, 2025. Costs incurred prior to or upon closing the Asset Acquisition in the prior three months ended March 31, 2026 were expensed as acquired in-process research and development.

(Press release, Tempest Therapeutics, AUG 13, 2026, View Source [SID1234670082])

Pilot Project Between BioCytics and LIDE Biotech

On August 13, 2026 BioCytics, Inc., and LIDE Biotech reported the formation of a strategic alliance to develop advanced screening platforms and companion diagnostics for immune-based cancer cell therapies. This collaboration combines BioCytics’ specialized cell manufacturing capabilities with LIDE’s unique, patient-derived xenograft technologies (PDX, miniPDX, and IO-based PDX models) to streamline the development of immuno-oncology (IO) treatments.

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The initial project based on the companies’ recently-executed Memorandum of Understanding will involve the creation of murine PDX models using human biospecimens from ethically consented patients on an institutional review board (IRB)-approved BioCytics tumor and immune cells collection study (View Source) that opened in 2007 and is still ongoing. These tumor models can then be used to observe a number of critical responses, such as drug resistance or induced cell death, for cells being treated in in vivo validation studies. Further model studies will involve DNA and RNA sequencing for additional response research such as human anti-tumor immune cell function.

BioCytics’ COO, Dr. Brent Dixon, says that "working with LIDE Biotech enables real breakthroughs in personalized medicine for cancer patients. We are excited about exploring our developments for autologous adaptive immune cell therapy (AAICT) within this unique model. We expect to learn more about the molecular pathways and signatures based upon the applied analytical methodologies."

This sentiment is echoed by Dr. Danyi Wen, LIDE’s Founder and CEO, who states that "LIDE is excited for its first-ever partnership with an American-based company to further deliver on our goals to support translational research for new drug R&D as well as personalized oncology. We are looking forward to working with BioCytics and leveraging its expertise to make LIDE technologies available outside of China. BioCytics’ patient-first vision is inspiring and truly aligns with LIDE’s mission to empower more scientists, accelerate more breakthroughs, and help move promising treatments one step closer to patients in need."

(Press release, BioCytics, AUG 13, 2026, View Source [SID1234670098])

Cellectar Biosciences Reports Second Quarter 2026 Financial Results and Provides Corporate Updates

On August 13, 2026 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 June 30, 2026, and provided a corporate update.

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"Our second quarter marked another period of significant execution as we continued to advance multiple programs across our oncology pipeline while laying the foundation for several important near-term catalysts," said James Caruso, president and chief executive officer of Cellectar. "Most notably, we progressed our regulatory strategy for iopofosine I 131 in Waldenström macroglobulinemia, including initiation of site activation activities for our confirmatory Phase 3 trial, which is an important first step toward our accelerated approval application in the U.S., which we plan to submit in mid-2027. The compelling data we continue to generate from the Phase 2b CLOVER WaM study reinforce our belief that iopofosine has the potential to address a critical unmet need for WM patients, including those previously treated with BTK inhibitors and prior to off-label salvage therapies."

"At the same time, we continued to expand the clinical validation of our proprietary PDC platform, achieving key enrollment and dosing milestones in our CLR 125 Phase 1b trial in triple-negative breast cancer and advancing our broader radiopharmaceutical portfolio. Supported by a strengthened balance sheet and a clear operational roadmap, we are entering the second half of 2026 with strong momentum, multiple anticipated data and development milestones, and a steadfast commitment to creating long-term value for patients and stockholders."

Second Quarter 2026 and Recent Corporate Highlights

Iopofosine I 131, the company’s Phospholipid Drug Conjugate (PDC) designed to provide targeted delivery of iodine-131 (radioisotope)
Presented data from the CLOVER WaM study of iopofosine I 131 in relapsed/refractory Waldenström macroglobulinemia (r/r WM) patients at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2026 Annual Meeting (ASCO) (Free ASCO Whitepaper). The poster presentation highlighted efficacy results from a subset of patients treated with iopofosine I 131 immediately post-Bruton Tyrosine Kinase inhibitor (BTKi) therapy, which consisted of two cycles administered at 15 mCi/m2 on days 1 and 15 of each 57-day cycle. Major response rate (MRR) was the primary efficacy endpoint, while the subset analysis also assessed a modified intent-to-treat (mITT) population who were immediately post-BTKi treatment.
Efficacy from the evaluable patients (n=24) included:
100% clinical benefit rate
87.5% overall response rate (ORR)
79.2% MRR, partial response (PR) or better
Median duration of response (DOR) of 16 months
(range: 7.3-25.4 months)
20% of patients exceeded 30 months DOR
Treatment was well-tolerated with a manageable toxicity profile with cytopenias as the only Grade 3 or greater adverse event.
Advanced preparations for the Phase 3 confirmatory trial of iopofosine I 131 and began site initiation activities. Sites are expected to begin opening in the coming months with first patient to be dosed in early 2027.
The Phase 3 study will be a comparator, randomized controlled study with approximately 100 WM patients per arm; full patient enrollment is projected within 18-24 months of the first patient admitted to the study.
The New Drug Application is planned for submission in mid-2027 under the FDA’s Accelerated Approval Program. Based on the Breakthrough Therapy Designation awarded to iopofosine I 131 for r/r WM, an approximate 6-month review is anticipated.
Published results from a Phase 1 dose-escalation study of iopofosine I 131 in combination with low-dose dexamethasone in patients with heavily pretreated relapsed/refractory multiple myeloma (r/r MM) in the peer-reviewed journal, Cancer.
Among 26 efficacy-evaluable patients, iopofosine I 131 achieved disease control in 84.6% of patients and an ORR of 15.4%, including four partial responses, with evidence of enhanced clinical activity at higher administered doses and a 30% ORR among evaluable patients receiving at least 60 mCi.
Treatment was generally well tolerated, with a favorable safety profile consisting primarily of predictable and reversible hematologic toxicities, no new safety signals, and mostly low-grade non-hematologic adverse events.
Given that iopofosine I 131’s mechanism of action is not dependent on a single target or mutation, the company believes these and other data underscore its potential to address a broad range of B-cell-mediated malignancies, including WM, MM, diffuse large B-cell lymphoma and other difficult-to-treat hematologic cancers where new therapeutic options are needed.
CLR 121125 (CLR 125), an iodine-125 Auger-emitting program targeted for solid tumor
Initiated enrollment and dosing of the first patients in the Phase 1b trial evaluating CLR 125 in refractory triple negative breast cancer (TNBC).
Phospholipid Drug Conjugate (PDC) Platform
On August 18th, Cellectar management will host a virtual educational webinar highlighting its validated PDC platform. The webinar will highlight the company’s Phospholipid Drug Conjugates’ (PDCs) ability to target and gain intracellular access to most primary tumors, metastatic sites, and cancer stem cells and will underscore how this approach may enhance drug efficacy and simultaneously minimize side effects for patients.
The event will showcase how this next-generation proprietary PLE delivery platform was engineered to be conjugated (combined) with a wide variety of therapeutic molecules, such as small-molecule chemotherapeutics, radiotherapeutics, and other molecules that utilize alternative therapeutic approaches.
Details of the webinar are below:
Date: August 18th, 2026
Time: 11:30 am – 12:30 pm ET
Registration Link: HERE
Corporate
In May 2026, the company entered into a securities purchase agreement with certain institutional investors and members of executive management to issue and sell an aggregate of approximately $35 million upfront and up to $105 million milestone-based securities in a registered direct offering of common stock and a concurrent private placement of common stock, pre-funded warrants and milestone-based warrants. Proceeds from this financing will primarily be used to fund the Phase 3 confirmatory study of iopofosine I 131 in WM.
2026 Financial Highlights

Cash and Cash Equivalents: As of June 30, 2026, the company had cash and cash equivalents of $34.0 million, compared to $13.2 million as of December 31, 2025, which reflects net proceeds of approximately $31.7 million from the May 2026 offering. The company believes its cash balance as of June 30, 2026, is adequate to fund its budgeted operations into the second quarter of 2027.
Research and Development Expenses: R&D expenses for the three months ended June 30, 2026, were approximately $4.6 million, compared to approximately $2.4 million for the three months ended June 30, 2025. The initiation of the WM confirmatory iopofosine I 131 and CLR 125 Triple Negative Breast Cancer studies drove the increase.
General and Administrative Expenses: G&A expenses for the three months ended June 30, 2026, were approximately $2.6 million, compared to approximately $3.6 million for the same period in 2025. The decrease was primarily a result of reduced commercialization efforts, professional fees, and lower personnel costs.
Net Loss: The net loss attributable to common stockholders for the three months ended June 30, 2026, was $6.9 million, or $0.57 per share, compared to $5.4 million, or $3.39 per share, for the three months ended June 30, 2025.
Conference Call & Webcast Details
Cellectar management will host a conference call and webcast today, August 13, 2026, 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, AUG 13, 2026, View Source [SID1234670062])