On August 14, 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 June 30, 2025, and provided a corporate update on its promising portfolio of clinical and pre-clinical radiopharmaceutical therapeutics (Press release, Cellectar Biosciences, AUG 14, 2025, View Source [SID1234655285]).

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Second Quarter and Subsequent Corporate Highlights

· Announces plans to pursue an NDA submission to the FDA for the accelerated approval of iopofosine I 131 as a treatment for WM subject to sufficient funding and once the confirmatory trial is underway

o The submission would be supported by data from the Phase 2b CLOVER WaM clinical trial demonstrating a statistically significant major response rate compared to a null hypothesis of 20% and meaningful duration of response. The data set now includes the FDA-requested 12-month follow-up results on all patients from the trial and new subset analysis of data from patients immediately following Bruton Tyrosine Kinase inhibitor (BTKi) treatment failures regardless of line of therapy.

o The Company plans to share these new data at an upcoming medical or scientific conference.

· Granted FDA Breakthrough Therapy Designation for iopofosine I 131, a potential first-in-class, novel cancer targeting agent utilizing a phospholipid ether as a radioconjugate monotherapy, for the treatment of relapsed/refractory WM.

· Received the EMA response regarding scientific advice on its submission for Conditional Market Authorization (CMA) and continues to work with the EMA toward a potential submission.

o The submission to EMA included data from the Phase 2b CLOVER WaM clinical trial where the company observed a statistically significant major response rate, meaningful duration of response and integrated summary of safety for all patients treated with iopofosine I 131 for hematologic malignancies.

o Scheduled a follow-up meeting with the EMA and expect to make a final decision to submit for a CMA late in the third quarter or early in the fourth quarter of 2025.

· Submitted a trial protocol with the FDA for a Phase 1b Dose Finding study of our Auger-emitting radiopharmaceutical, CLR 125, for the treatment of relapsed TNBC. CLR 125 is an iodine-125 Auger-emitting drug candidate targeting solid tumors, such as triple negative breast, lung and colorectal cancers.

· Reported a positive initial data update from the Phase 1 clinical trial of iopofosine I 131 in pediatric patients with relapsed/refractory high-grade glioma (pHGG).

o All patients receiving a minimum of 55 mCi total administered dose (n=7) experienced an average of 5.4 months of progression free survival (PFS) and 8.6 months of overall survival (OS), ongoing.

o All patients experienced disease control, which correlates with survival benefit.

o Three patients who received additional dosing cycles (a minimum of four total infusions) had an average PFS of 8.1 months and an OS of 11.5 months (ranging from 4.9 to 14.9 months), ongoing, with two achieving an objective response.

· In active discussions with multiple potential partners for the regional or global licensing of iopofosine I 131 which are designed to provide funding to support the submission of an NDA for accelerated approval and the required confirmatory study.

· Entered a long-term multi-isotope supply agreement with Nusano to provide Cellectar with iodine-125 and actinium-225 for its clinical studies and future commercial needs.

· Raised nearly $9.5 million through separate June and July 2025 financings. Funds from these financings will be used to advance the Company’s next-generation pipeline of radiopharmaceuticals in solid tumors into the clinic and to continue regulatory engagement and partnership discussions for iopofosine I 131.

"Throughout the first half of 2025 we made meaningful progress advancing our pipeline of targeted radiopharmaceuticals and are entering the second half with solid momentum and a clear plan," said James Caruso, president and CEO of Cellectar. We are encouraged by the recent FDA Breakthrough Therapy Designation and the totality of compelling CLOVER WaM safety and efficacy data. Importantly, our regulatory strategy aligns with the FDA’s recently stated mission to accelerate the delivery of lifesaving medicines to patients battling rare diseases, such as WM."

"We continue our interactions with the European Medicines Agency (EMA) and are hopeful that they will recommend that we file for a fast-track, conditional marketing authorization approval. We expect their decision either late third or early in the fourth quarter of 2025. In parallel, we remain in active discussions with multiple potential partners to support the NDA filing for accelerated approval of iopofosine I 131 for the treatment of WM. Currently, we view sufficient funding or collaborations as a precursor to the confirmatory study initiation and submission of an NDA for accelerated approval. Such partnerships may provide non-dilutive capital that preserves stockholder value and could potentially accelerates our path to commercialization across key global markets."

"Beyond iopofosine, we are making tremendous headway advancing our next-generation pipeline of radiopharmaceuticals targeting solid tumors, such as triple-negative breast cancer (TNBC) and pancreatic cancer. We plan to advance CLR 125 into the clinic by late 2025 or early 2026. The FDA has received our Phase 1 protocol submission for the CLR 125 program. We are excited by the opportunities Cellectar possesses to bring transformative radiopharmaceutical therapies to patients in need and look forward to achieving value-creating milestones throughout the balance of the year and beyond," concluded Mr. Caruso.

Second Quarter 2025 Financial Highlights

· Cash and Cash Equivalents: As of June 30, 2025, the company had cash and cash equivalents of approximately $11.0 million, compared to $23.3 million as of December 31, 2024, which includes $2.3 million in net proceeds received in connection with the company’s June warrant exercises but does not reflect net proceeds of approximately $5.8 million from the July 2025 offering. The company believes its cash balance as of June 30, 2025, inclusive of the additional funds raised in July, is adequate to fund its basic budgeted operations into the second quarter of 2026.

· Research and Development Expenses: R&D expenses for the three months ended June 30, 2025, were approximately $2.4 million, compared to approximately $7.3 million for the three months ended June 30, 2024. The overall lower expense was primarily driven by decreased clinical project costs and manufacturing and related costs resulting from the conclusion of patient enrollment in our CLOVER WaM Phase 2b clinical trial.

· General and Administrative Expenses: G&A expenses for the three months ended June 30, 2025, were approximately $3.6 million, compared to approximately $6.4 million for the same period in 2024. The reduction was the result of decreased commercialization activities and personnel costs.

· Net Loss: The net loss attributable to common stockholders for the three months ended June 30, 2025, was $5.4 million, or $3.39 per primary and diluted share, compared to $0.9 million, or $0.77 per primary share and $5.43 per diluted share in the three months ended June 30, 2024.

Conference Call & Webcast Details

Cellectar management will host a conference call and webcast today, August 14, 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.

On August 14, 2025 Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, reported financial results for the second quarter ended June 30, 2025 and other recent business developments (Press release, Celcuity, AUG 14, 2025, View Source [SID1234655284]).

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"We have had an eventful past few months at Celcuity. Last month, we announced positive topline data from the PIK3CA wild-type cohort of the pivotal Phase 3 VIKTORIA-1 clinical trial, which showed unprecedented reduction in risk of disease progression or death and incremental improvement in progression free survival in patients with HR+/HER2- advanced breast cancer," said Brian Sullivan, CEO and co-founder of Celcuity. "We believe topline data for both gedatolisib regimens from VIKTORIA-1 are potentially practice-changing. We are on track to submit the New Drug Application for gedatolisib, based on data from the PIK3CA wild-type cohort, later this year and to report topline data from the PIK3CA mutant cohort in the fourth quarter of 2025. Additionally, with our recent financing and our growing body of clinical data, we believe we are in a unique position to advance multiple potential blockbuster indications in breast and prostate cancer."

Second Quarter 2025 Business Highlights and Other Recent Developments

● In July 2025, the Company announced positive topline data for both primary endpoints of the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 clinical trial that evaluated gedatolisib plus fulvestrant with and without palbociclib versus fulvestrant in patients with HR+/HER2- ABC whose disease had progressed on or after prior treatment with a CDK4/6 inhibitor. The efficacy results established several new milestones in the history of drug development for HR+/HER2- ABC.

○ The gedatolisib triplet (gedatolisib, fulvestrant and palbociclib) reduced the risk of disease progression or death by 76% compared to fulvestrant based on a hazard ratio ("HR") of 0.24. The median PFS was 9.3 months with the gedatolisib triplet versus 2.0 months with fulvestrant, an incremental improvement of 7.3 months.

○ The gedatolisib doublet (gedatolisib and fulvestrant) reduced the risk of disease progression or death by 67% compared to fulvestrant based on a hazard ratio of 0.33. The median PFS was 7.4 months with the gedatolisib doublet versus 2.0 months with fulvestrant, an incremental improvement of 5.4 months.

○ Both gedatolisib regimens showed lower rates of hyperglycemia and stomatitis and the rate of discontinuation of all treatment due to a treatment-related adverse event ("AE"), was lower than was reported in a Phase 1b study in this patient population.

○ Full data from the PIK3CA wild-type cohort of the VIKTORIA-1 clinical trial will be presented at an upcoming medical conference later this year.

○ Celcuity expects to submit an NDA to the FDA in the fourth quarter of 2025 for gedatolisib based on data from the PIK3CA wild-type cohort.

○ Enrollment is ongoing in the PIK3CA mutant cohort of the VIKTORIA-1 trial and remains on track to report topline data by the end of 2025.

● In July 2025, the first patient was dosed in VIKTORIA-2, a Phase 3 clinical trial evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as a first-line treatment for patients with HR+/HER2- ABC who are endocrine therapy resistant.

● In July 2025, the US Patent and Trademark Office issued a new patent for gedatolisib covering the dosing regimen used in the VIKTORIA-1 clinical trial, extending the patent exclusivity in the U.S. into 2042.

● In July 2025, the Company conducted a concurrent public offering of 2.750% convertible senior notes due 2031, common stock and pre-funded warrants. The net proceeds from the offerings were $286.5 million, after deducting underwriting discounts and commissions and the Company’s estimated offering expenses.

● In June 2025, the Phase 1b portion of the CELC-G-201 study reported positive topline data, and additional preliminary results will be presented at a medical conference later this year.

○ As of the May 30, 2025 data cut-off, the preliminary efficacy and safety analyses for the combined arms showed the six-month radiographic progression free survival rate was 66%, no patients discontinued treatment due to a treatment-related AE, and no dose reductions were required with gedatolisib or darolutamide.

● In June 2025, the Company presented key efficacy and safety results from an investigator-sponsored Phase 2 clinical trial in 44 patients with HER2+/ PIK3CA mutated mBC, who were treated with gedatolisib plus standard doses of trastuzumab-pkrb, at the American Society of Clinical Oncologists meeting, which showed the objective response rate among all patients enrolled was 43%.

Second Quarter 2025 Financial Results

Unless otherwise stated, all comparisons are for the second quarter ended June 30, 2025, compared to the second quarter ended June 30, 2024.

Total operating expenses were $44.0 million for the second quarter of 2025, compared to $24.3 million for the second quarter of 2024.

Research and development ("R&D") expenses were $40.2 million for the second quarter of 2025, compared to $22.5 million for the prior-year period. Of the approximately $17.7 million increase in R&D expenses, $6.6 million was related to increased employee and consulting expenses, $6.1 million was related to increased research and development costs primarily attributable to activities supporting our ongoing clinical trials, and $5.0 million is related to an anticipated development milestone payment under the license agreement with Pfizer.

General and administrative ("G&A") expenses were $3.8 million for the second quarter of 2025, compared to $1.8 million for the prior-year period. Of the approximately $2.0 million increase in general and administrative expenses, $1.6 million was related to increased employee and consulting expenses. The remaining $0.4 million of the $2.0 million increase resulted from professional fees, expanding infrastructure and other administrative expenses.

Net loss for the second quarter of 2025 was $45.3 million, or $1.04 loss per share, compared to a net loss of $23.7 million, or $0.62 loss per share, for the second quarter of 2024. Non-GAAP adjusted net loss for the second quarter of 2025 was $40.5 million, or $0.93 loss per share, compared to non-GAAP adjusted net loss of $22.2 million, or $0.58 loss per share, for the second quarter of 2024. Non-GAAP adjusted net loss excludes stock-based compensation expense, non-cash interest expense, and non-cash interest income. Because these items have no impact on Celcuity’s cash position, management believes non-GAAP adjusted net loss better enables Celcuity to focus on cash used in operations. For a reconciliation of financial measures calculated in accordance with generally accepted accounting principles in the United States ("GAAP") to non-GAAP financial measures, please see the financial tables at the end of this press release.

Net cash used in operating activities for the second quarter of 2025 was $36.2 million, compared to $18.1 million for the second quarter of 2024.

At June 30, 2025, Celcuity reported cash, cash equivalents and short-term investments of $168.4 million. However, on a proforma basis, taking into account the net proceeds of the Celcuity’s financing activities in the third quarter, cash, cash equivalents, and short-term investments as of the end of Q2 2025 was $455 million, which, we believe, when including drawdowns on our debt facility, will fund operations through 2027.

Webcast and Conference Call Information

The Celcuity management team will host a webcast/conference call at 4:30 p.m. ET today to discuss the second quarter 2025 financial results and provide a corporate update. To participate in the teleconference, domestic callers should dial 1-800-717-1738 and international callers should dial 1-646-307-1865. A live webcast presentation can also be accessed using this weblink: View Source;tp_key=047c56f7b8. A replay of the webcast will be available on the Celcuity website following the live event.

On August 14, 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 second quarter ended June 30, 2025, and provided a corporate update (Press release, Candel Therapeutics, AUG 14, 2025, View Source [SID1234655283]).

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"This quarter marked several pivotal achievements for Candel, highlighted by the FDA RMAT Designation for CAN-2409, and being selected for an oral presentation at ASCO (Free ASCO Whitepaper), reflecting the strength of the data based on our pivotal phase 3 clinical trial in localized prostate cancer," said Paul Peter Tak, M.D. Ph.D. FMedSci, President and CEO of Candel. "Further, the addition of Dr. Maha Radhakrishnan to our Board of Directors, as well as the appointment of Charles Schoch as Chief Financial Officer, further strengthens our organization as we accelerate our pre-commercialization activities and advance toward BLA submission, anticipated in Q4 2026."

Dr. Tak continued, "The positive results from our clinical trials in prostate cancer, pancreatic cancer, and non-small cell lung cancer reinforce the therapeutic potential of CAN-2409 as a novel therapy. With the proceeds from our recent registered direct offering being utilized to support pre-commercialization and launch readiness activities, and with multiple regulatory designations, we believe we are well-positioned to execute on our near-term milestones and advance toward our goal of bringing this important treatment option to patients with prostate cancer."

Second Quarter 2025 & Recent Highlights

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CAN-2409 – Prostate Cancer
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In an oral presentation at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting on June 3, 2025, in Chicago, IL, the Company reported phase 3 results from the CAN-2409 clinical trial in intermediate-to-high risk localized prostate cancer. The primary endpoint, agreed with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA), was met, with a statistically significant improvement of 30% in disease-free survival among CAN-2409 recipients (HR 0.70, p=0.0155) when compared to placebo, both in combination with standard-of-care external beam radiation therapy. This data was supported by secondary endpoints.
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On June 3, 2025, Candel hosted a conference call featuring perspectives from leading prostate cancer specialists, John E. Sylvester, M.D., Atlantic Urology Clinics, Myrtle Beach, South Carolina, and Ronald F. Tutrone, Jr., M.D., FACS, CPI, National Medical Director of Clinical Research, United Urology Group, Towson, Maryland. Both physicians were principal investigators on the trial. The call replay can be accessed here.
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This phase 3 study was conducted under a SPA agreed with the FDA, meaning that certain data generated from this study could be sufficient for the Company to seek regulatory approval for CAN-2409 in this indication.
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The Company is advancing its pre-BLA readiness, including through Chemistry, Manufacturing, and Controls (CMC) activities and documentation, and preparation of clinical study reports.
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In May, the Company received RMAT Designation from the FDA for CAN-2409 for the treatment of newly diagnosed, localized prostate cancer in patients with intermediate-to-high-risk disease. The FDA previously granted Fast Track Designation for CAN-2409 for the treatment of localized primary prostate cancer.
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The Company continues to work toward a BLA submission for CAN-2409 in prostate cancer in Q4 2026.
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CAN-2409 – Non-Small Cell Lung Cancer (NSCLC)

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In March, the Company reported positive overall survival data from its phase 2a clinical trial of CAN-2409 in patients with stage III/IV NSCLC inadequately responding to ICI treatment.
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In patients with an inadequate response to ICI treatment (Cohorts 1+2, n=46), median overall survival (mOS) was 24.5 months.
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In patients with progressive disease, despite ICI treatment (Cohort 2, n=41), mOS was 21.5 months, which is markedly longer than the 9.8–11.8 months of survival reported in published literature1,2 in the same patient population receiving standard of care of docetaxel chemotherapy.
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37% of patients with progressive disease at enrollment were still alive > 24 months after CAN-2409 treatment at the time of the March 3, 2025 data cut, suggesting a long tail of survival. 14/15 patients with overall survival > 24 months and 9/9 patients with overall survival > 30 months had non-squamous NSCLC.
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In patients with non-squamous NSCLC and progressive disease despite ICI (cohort 2, n=33), observed mOS was 25.4 months after CAN-2409 treatment.
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A decrease in the size of uninjected tumors was observed in 69% of patients with multiple lesions (n=35), indicating that a local injection is associated with a systemic anti-tumor immune response.
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CAN-2409 maintained its generally favorable safety and tolerability profile throughout the extended follow-up period.
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The FDA previously granted Fast Track Designation for CAN-2409 for the treatment of NSCLC.
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CAN-2409 – Pancreatic Cancer
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In February 2025, the Company reported positive overall survival data from the randomized, controlled, phase 2a clinical trial of CAN-2409 in borderline resectable pancreatic ductal adenocarcinoma (PDAC).
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Patients who had received experimental treatment with CAN-2409 and chemoradiotherapy achieved a mOS of 31.4 months versus 12.5 months observed in the control arm treated with chemoradiotherapy.
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Notably, three out of seven patients in the CAN-2409 arm were long-term survivors and remained alive at 66.0, 63.6, and 35.8 months post-treatment, whereas only one out of six patients from the control arm was still alive at the time of data cut-off (February 20, 2025). Patients in the CAN-2409 arm were stable at the time of last follow up with minimal maintenance therapy and, despite previous recurrence, experienced extended and ongoing post-progression survival, further highlighting the sustained benefit of CAN-2409, even in metastatic disease.
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The FDA previously granted Orphan Drug Designation and Fast Track Designation for CAN-2409 in borderline resectable PDAC.

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The EMA granted Orphan Designation for CAN-2409 for the treatment of pancreatic cancer in July 2025.
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Recent Corporate Events
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In June 2025, the Company completed a registered direct offering, of approximately 3.2 million shares of its common stock, to a select group of existing healthcare-focused institutional investors, executive officers, and directors of the Company, at a price per share of $4.67, resulting in gross proceeds of approximately $15 million, before deducting offering expenses payable by the Company.
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In June 2025, the Company appointed Charles Schoch as Chief Financial Officer (CFO). Mr. Schoch previously served as interim CFO of Candel. He will continue to be instrumental as the Company advances its clinical pipeline and prepares for BLA submission of CAN-2409 in localized prostate cancer, anticipated in Q4 2026.
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In June 2025, the Company appointed Maha Radhakrishnan, M.D., to its Board of Directors. Dr. Radhakrishnan has significant expertise in product development and commercialization.
Anticipated Milestones

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Additional clinical and biomarker activity data from an ongoing phase 1b clinical trial evaluating repeat doses of CAN-3110 in patients with recurrent high-grade glioma (rHGG), is expected in Q4 2025.
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Candel plans to host a virtual Research and Development event in Q4 2025.
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Submission of BLA for CAN-2409 in prostate cancer expected in Q4 2026.
Financial Results for the Second Quarter Ended June 30, 2025

Research and Development Expenses: Research and development expenses were $7.0 million for the second quarter of 2025 compared to $5.0 million for the second quarter of 2024. The increase was primarily due to an increase in manufacturing costs in support of the Company’s CAN-2409 programs, partially offset by a decrease in employee-related expenses, which was driven primarily from a reduction in stock-based compensation expense. Research and development expenses included a non-cash stock compensation expense of $0.4 million for the second quarter of 2025 compared to a non-cash stock compensation expense of $1.3 million for the second quarter of 2024.

General and Administrative Expenses: General and administrative expenses were $4.2 million for the second quarter of 2025, compared to $3.6 million for the second quarter of 2024. The increase was primarily due to an increase in commercial readiness costs as well as higher professional and consulting fees. General and administrative expenses included non-cash stock compensation expense of $0.6 million for both the second quarter of 2025 and the second quarter of 2024.

Net Loss: Net loss for the second quarter of 2025 was $4.8 million compared to a net loss of $22.2 million for the second quarter of 2024 and included net other income of $6.4 million and net other expense of $13.7 million, respectively. The decrease in net loss was primarily related to the change in the fair value of the Company’s warrant liability.

Cash Position: Cash and cash equivalents, as of June 30, 2025, were $100.7 million compared to $102.7 million as of December 31, 2024. Based on current plans and assumptions, the Company expects that its existing cash and cash equivalents will be sufficient to fund operations into Q1 2027, including the Company’s expected submission of the BLA for CAN-2409 in intermediate-to-high-risk prostate cancer to the FDA in Q4 2026.

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 with a favorable tolerability profile to date, supporting the potential for combination with standard of care, when indicated.

About CAN-3110

CAN-3110 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. CAN-3110 is being evaluated in a phase 1b clinical trial in patients with rHGG. In October 2023, the Company announced that Nature published results from this ongoing clinical trial. CAN-3110 was well tolerated with no dose-limiting toxicity reported. In the clinical trial, the investigators observed improved median overall survival compared to historical controls after a single CAN-3110 injection in this therapy-resistant condition.3 The Company and academic collaborators are currently evaluating the effects of repeat CAN-3110 injections in rHGG, supported by the Break Through Cancer foundation. CAN-3110 has previously received FDA Fast Track Designation and Orphan Drug Designation for the treatment of rHGG.

On August 14, 2025 Bolt Biotherapeutics (Nasdaq: BOLT), a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer, reported financial results for the second quarter ended June 30, 2025, and provided a business update (Press release, Bolt Biotherapeutics, AUG 14, 2025, View Source [SID1234655282]).

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"In the second quarter we focused on advancing BDC-4182, the first next-generation Boltbody ISAC in our pipeline," said Willie Quinn, President and Chief Executive Officer. "We are now conducting a Phase 1 dose-escalation study for patients with gastric and gastroesophageal cancer in Australia, and will expand to other countries in the second half of 2025. We look forward to presenting initial data in the first half of 2026. We also continue to seek a partner for further development of our dectin-2 agonist antibody BDC-3042, which demonstrated activity in lung cancer patients in the form of a partial response (PR) at the highest dose tested. Patients at the highest doses also had a strong immune response consistent with our expectations based on preclinical data."

Recent Highlights and Anticipated Milestones

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Our BDC-4182 Phase 1 study opened for enrollment for patients with gastric and gastroesophageal cancer in the first half of 2025. BDC-4182 is a next-generation Boltbody ISAC clinical candidate targeting claudin 18.2, a clinically validated target in oncology with expression in gastric/gastroesophageal junction cancer, pancreatic cancer, and other tumor types. Preclinically, monotherapy treatment with BDC-4182 generated complete regressions in multiple models and BDC-4182 was tolerated in toxicology studies. BDC-4182 outperformed cytotoxic claudin 18.2 ADCs, using MMAE or Topo1, in multiple preclinical studies.
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Collaborations with Genmab and Toray continue to progress. Genmab and Bolt are advancing multiple development candidates , while the companies also continue research and development on additional programs. The Toray collaboration combines the Company’s immunostimulatory linker-payloads with Toray antibodies targeting Caprin-1, a tumor-specific antigen that is strongly expressed on the cell membrane in multiple solid tumor types.
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Seeking a partner for further BDC-3042 development. In May, Bolt hosted a KOL conference call with BDC-3042 investigator Dr. Dumbrava to discuss the results from the Phase 1 dose-escalation clinical study of BDC-3042 that were presented at the American Associates for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting that took place in April 2025. Bolt completed the dose escalation and is seeking a partner.
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Cash, cash equivalents, and marketable securities were $48.5 million as of June 30, 2025. Cash on hand is expected to fund multiple milestones and operations through mid-2026.

Second Quarter 2025 Financial Results

• Collaboration Revenue – Total collaboration revenue was $1.8 million for the quarter ended June 30, 2025, compared to $1.3 million for the same quarter in 2024. Revenue in the comparative periods was generated from services performed under the R&D collaborations as we fulfill our performance obligations.

• Research and Development (R&D) Expenses – R&D expenses were $7.5 million for the quarter ended June 30, 2025, compared to $15.4 million for the same quarter in 2024. The decrease between the comparable periods was mainly due to a decrease in salary and related expenses, a decrease in clinical expenses primarily related to the discontinued development of trastuzumab imbotolimod, formerly known as BDC-1001 in May 2024.

• General and Administrative (G&A) Expenses – G&A expenses were $3.5 million for the quarter ended June 30, 2025, compared to $4.9 million for the same quarter in 2024. The decrease between the comparable periods was mainly due to a decrease in salary and related expenses primarily as a result of the May 2024 restructuring.

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Restructuring Charges – Restructuring charges were zero for the quarter ended June 30, 2025, compared to $3.6 million for the same quarter in 2024, consisting of $2.9 million of one-time termination benefits such as severance costs and related benefits and $0.7 million of non-cash stock-based compensation expense as a result of the restructuring plan.
• Loss from Operations – Loss from operations was $9.2 million for the quarter ended June 30, 2025, compared to $22.6 million for the same quarter in 2024.

Other Developments

Reverse Stock Split

On June 6, 2025, we effected a one-for-twenty (1:20) reverse stock split of its outstanding common stock, effective as of June 6, 2025 (the "Reverse Stock Split"). As a result of the Reverse Stock Split, every 20 shares of the Company’s issued and outstanding common stock automatically converted into one issued and outstanding share of common stock, without any change in par value per share. In part, due to the Reverse Stock Split, on June 24, 2025, Nasdaq notified the Company that it had regained compliance with Nasdaq’s minimum bid price requirement.

About the Boltbody Immune-Stimulating Antibody Conjugate (ISAC) Platform
Bolt Biotherapeutics’ Boltbody ISAC platform harnesses the precision of antibodies with the power of the innate and adaptive immune system to generate a productive anti-cancer response. Each Boltbody ISAC candidate comprises a tumor-targeting antibody, a non-cleavable linker, and a proprietary immune stimulant. The antibody is designed to target one or more markers on the surface of a tumor cell and the immune stimulant is designed to recruit and activate myeloid cells. Activated myeloid cells initiate a positive feedback loop by releasing cytokines and chemokines, chemical signals that attract other immune cells and lower the activation threshold for an immune response. This increases the population of activated immune system cells in the tumor microenvironment and promotes a robust immune response with the goal of generating durable therapeutic responses for patients with cancer.

On August 14, 2025 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a development stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, reported its unaudited financial results for the quarter ended June 30, 2025, and provided a corporate update (Press release, BioLineRx, AUG 14, 2025, View Source [SID1234655281]).

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"Since our last quarterly update, we have been acutely focused on evaluating a broad range of potential pipeline expansion opportunities where we can leverage our clinical and regulatory expertise, and track record of drug approval success, to drive new innovation in areas of need," said Philip Serlin, Chief Executive Officer of BioLineRx. "Today, I am pleased to report that discussions with potential partners continue to progress. Our balance sheet is strong, our organization is lean, and we are seeing promising opportunities that fit well within our criteria – most notably a clear and efficient development pathway. I remain confident that we could potentially execute a transaction this year that will expand our pipeline and provide fresh opportunities for clinical success and long-term value creation."

Financial Updates

With $28.2 million on its balance sheet as of June 30, 2025, BioLineRx is guiding to a cash runway into the first half of 2027. This represents an improvement as compared to the Company’s previous cash runway guidance into the second half of 2026.
Clinical Updates
Motixafortide
Pancreatic Ductal Adenocarcinoma (mPDAC)

Enrollment activities continue in the CheMo4METPANC Phase 2b clinical trial, which is being led by Columbia University, and supported by both Regeneron and BioLineRx. The CheMo4METPANC trial is evaluating motixafortide in combination with the PD-1 inhibitor cemiplimab and standard chemotherapy (gemcitabine and nab-paclitaxel).
A prespecified interim analysis is planned when 40% of progression-free survival (PFS) events are observed.
An abstract featuring updated data from the pilot phase of the ongoing CheMo4METPANC clinical trial was presented at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting in May. Key highlights include:
– Four of 11 patients remained progression-free after more than one year.
– Two patients underwent definitive treatment for metastatic pancreatic cancer: one had complete resolution of all radiologically detected liver lesions and underwent radiation to the primary pancreatic tumor, and one had a sustained partial response and underwent pancreaticoduodenectomy with pathology demonstrating a complete response.
– An analysis of pre- and on-treatment biopsies revealed that CD8+ T-cell tumor infiltration increased across all eleven patients treated with the motixafortide combination.
Sickle Cell Disease (SCD) & Gene Therapy

Ongoing Phase 1 clinical trial evaluating motixafortide as monotherapy and in combination with natalizumab for stem cell mobilization for gene therapies in sickle cell disease continues to progress. The trial is sponsored by Washington University School of Medicine in St. Louis, and results are anticipated in the second half of 2025.
A second study, sponsored by St. Jude Children’s Research Hospital, continues to enroll patients. The study is a multi-center Phase 1 clinical trial evaluating motixafortide for the mobilization of CD34+ hematopoietic stem cells (HSCs) used in the development of gene therapies for patients with Sickle Cell Disease (SCD).
APHEXDA Performance Update

APHEXDA generated sales of $1.7 million in the second quarter of 2025, providing royalty revenue to the Company of $0.3 million.
Financial Results for the Quarter Ended June 30, 2025

Total revenues for the second quarter of 2025 were $0.3 million, reflecting the royalties paid by Ayrmid from the commercialization of APHEXDA in stem cell mobilization in the U.S. Total revenues in 2025 are not comparable to the same period in 2024, which included direct commercial sales by BioLineRx prior to the Ayrmid transaction in November 2024.

Cost of revenues for the second quarter of 2025 was immaterial, compared to cost of revenues of $0.9 million for the second quarter of 2024. Cost of revenues in 2025 are not comparable to the same period in 2024, which included cost of sales from direct commercial sales by BioLineRx prior to the Ayrmid transaction in November 2024.

Research and development expenses for the second quarter of 2025 were $2.3 million, compared to $2.2 million for the second quarter of 2024. The increase resulted primarily from certain one-time costs associated with the PDAC study at Columbia University, offset by lower expenses related to motixafortide due to the out-licensing of U.S. rights to Ayrmid, as well as a decrease in payroll and share-based compensation, primarily due to a decrease in headcount.

There were no sales and marketing expenses for the second quarter of 2025, compared to $6.4 million for the second quarter of 2024. The decrease resulted primarily from the shutdown of U.S. commercial operations in the fourth quarter of 2024 following the Ayrmid transaction.

General and administrative expenses for the second quarter of 2025 were $0.2 million, compared to $1.6 million for the second quarter of 2024. The decrease resulted primarily from the reversal of a provision for doubtful accounts following receipt of an overdue milestone payment from Gloria, a decrease in payroll and share-based compensation, primarily due to a decrease in headcount, as well as small decreases in a number of general and administrative expenses.

Net non-operating expenses for the second quarter of 2025 were $1.9 million, compared to net non-operating income of $7.8 million for the second quarter of 2024. Non-operating income (expenses) for both periods primarily relate to fair-value adjustments of warrant liabilities on the balance sheet, as a result of changes in the Company’s share price

Net financial income for the second quarter of 2025 was $0.2 million, compared to net financial expenses of $1.6 million for the second quarter of 2024. Net financial income (expenses) for both periods primarily relate to loan interest paid, partially offset by investment income earned on bank deposits and gains on foreign currency (primarily NIS) cash balances due to the strengthening of the NIS during the period. The significant decrease in financial expenses in the 2025 period results from a substantial paydown of the BlackRock loan balance in November 2024, following the transaction with Ayrmid.

Net loss for the second quarter of 2025 was $3.9 million, compared to net income of $0.5 million for the second quarter of 2024.

As of June 30, 2025, the Company had cash, cash equivalents, and short-term bank deposits of $28.2 million, sufficient to fund operations, as currently planned, into the first half of 2027.
Conference Call and Webcast Information
To access the conference call, please dial +1-888-281-1167 from the U.S. or +972-3-918-0685 internationally. A live webcast and a replay of the call can be accessed through the event page on the Company’s website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast. The call replay will be available approximately two hours after completion of the live conference call. A dial-in replay of the call will be available until August 16, 2025; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.