On March 13, 2025 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development, and commercialization of drugs for the treatment of cancer, reported financial results for the year ended December 31, 2024, and provided a corporate update (Press release, Cellectar Biosciences, MAR 13, 2025, View Source [SID1234651125]).

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"In 2024 the company showcased the efficacy and safety of iopofosine I 131 for the treatment of relapsed/refractory Waldenström macroglobulinemia. We recently completed a productive meeting with the FDA that established a clear regulatory pathway for the accelerated approval of this promising drug. Based upon this regulatory clarity, the quality of the CLOVER-WaM data, and a robust global market opportunity, we continue to evaluate inbound inquiries regarding a range of collaborations for iopofosine I 131, which we view as an attractive, non-dilutive funding approach." said James Caruso, president and CEO of Cellectar. "In addition, the company received clearance for an IND for our Auger-emitting radioconjugate and will be submitting an IND application for our alpha-emitting radioconjugate. By the middle of 2025 we will be prepared to advance into phase 1 clinical studies for both compounds, in triple negative breast cancer and pancreatic cancer indications, respectively."

2024 and Recent Corporate Highlights

· Finalized confirmatory study design and regulatory pathway for potential FDA accelerated approval of iopofosine I 131, the Company’s targeted radiotherapeutic candidate for the treatment of relapsed/refractory WM.

o The study will be a randomized, controlled trial of iopofosine I 131 versus a comparator arm, with 100 patients per arm.

o Two-stage approval process includes conditional accelerated approval based on a major response rate (MRR) endpoint with full approval based upon achieving a progression-free survival endpoint.

o Company expects to complete full patient enrollment within 24 months of the first patient admitted to the study.

o Total study cost is expected to be between $40M-$45M, with approximately $30M to full enrollment.

· Presented data from the Phase 2 CLOVER-WaM study in an oral session at the 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (ASH 2024) in December. The oral presentation highlighted that treatment with iopofosine I 131 in patients suffering from relapsed/refractory WM demonstrated:

o overall Response Rate (ORR) was 83.6%;

o major Response Rate (MRR) was 58.2%, which exceeded the FDA agreed-upon primary endpoint of 20% MRR;

o durable efficacy in previously treated WM patients, with no current standard of care therapy;

o well tolerated with a manageable toxicity profile across broad biologic and clinical subgroups.

· An article published in the journal eBioMedicine, volume 111, 2025, 105496, ISSN 2352-3964 from a SPORE Grant-supported, investigator-led study utilizing iopofosine I 131 (also known as CLR 131) in combination with external beam radiation, reported the best overall response from 11 evaluable patients included seven participants with a complete response (63.6%), one with a partial response (9%), one with stable disease (9%), and two with disease progression (18%), further supporting iopofosine I 131’s therapeutic benefit in solid tumors.

· Continued development of CLR 121225 and CLR 121125, the Company’s pre-clinical radioconjugate assets, to support Phase 1 solid tumor studies:

o The company is prepared to initiate a Phase 1b/2a dose-finding study with CLR 121125 in triple-negative breast cancer. CLR 121125 is the company’s lead Auger-emitting (iodine-125) Phospholipid Radioconjugate (PRC) that provides the greatest precision in targeted radiotherapy as emissions only travel a few nanometers.

o The company plans to file an IND application in the first half of 2025 for CLR 121225. CLR 121225 is Cellectar’ s lead alpha-emitting (actinium-225) PRC, which has demonstrated activity in multiple solid tumor animal models, including pancreatic and colorectal cancer.

2024 Financial Highlights

· Cash and Cash Equivalents: As of December 31, 2024, the company had cash and cash equivalents of $23.3 million, compared to $9.6 million as of December 31, 2023. In 2024, Cellectar executed multiple financial transactions, including investors’ exercise of warrants in January 2024 that generated $44.1 million, and an inducement financing in July 2024, which included the exercise of existing warrants and the purchase of new warrants for an additional $19.4 million. The company believes its cash balance as of December 31, 2024, is adequate to fund its basic budgeted operations into the fourth quarter of 2025.

· Research and Development Expenses: R&D expenses for the year ended December 31, 2024, were approximately $26.1 million, compared to approximately $27.3 million for the year ended December 31, 2023. The decrease was primarily a result of the timing of expenditures for our WM Phase 2 study to support final patient visits, partially offset by the extensive analytic work necessary to prepare for a planned regulatory submission, product sourcing, manufacturing, and logistics infrastructure costs to support multi sourcing for each aspect of iopofosine I 131 production.

· General and Administrative Expenses: G&A expenses for the year ended December 31, 2024, were approximately $25.6 million, compared to approximately $11.7 million for the same period in 2023. The increase was primarily driven by costs associated with the development of infrastructure necessary to support potential commercialization, including the related marketing and personnel costs.

· Other income and expense: Other income and expense, net, was approximately $7.3 million of income in 2024, as compared to approximately $3.9 million of expense in the prior year. These amounts are almost exclusively non-cash and driven by the issuance and valuation of equity securities in conjunction with financing activities. The only cash impact was interest income, which for 2024 improved to approximately $1.2 million from $0.4 million in the prior year.

· Net Loss: Net loss for the full year ending December 31, 2024, was $44.6 million or $1.22 per basic share and $1.40 per diluted share, compared with $42.8 million or $3.50 per basic and diluted share during 2023.

Conference Call & Webcast Details

Cellectar management will host a conference call and webcast today, March 13, 2024, 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 March 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 fourth quarter and year ended December 31, 2024, and provided a corporate update (Press release, Candel Therapeutics, MAR 13, 2025, View Source [SID1234651126]).

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"Last year was transformational for Candel, driven by our team’s incredible focus and execution of the Company’s key priorities," said Paul Peter Tak, MD PhD FMedSci, President and CEO of Candel. "We delivered positive data across our platforms, including pivotal topline phase 3 data for CAN-2409 in intermediate-to-high-risk localized prostate cancer in December, which we believe shows the potential of CAN-2409, if approved, to redefine the current standard of care for patients with prostate cancer."

Dr. Tak continued, "We enter 2025 well-resourced with a clear direction and mandate. Our primary focus for the year is working toward readiness to submit CAN-2409’s BLA for prostate cancer, a key opportunity to address a very significant unmet need and opportunity for value creation. In addition, we continue to explore the efficacy of CAN-2409 in other indications, as evidenced by our recently disclosed positive final overall survival data for CAN-2409 in a randomized controlled phase 2a trial in borderline resectable pancreatic cancer. This result has triggered enabling work, which will include scientific advisory boards and engagement with the FDA, to get ready for a larger, late-stage, randomized clinical trial in this indication in the future. In addition, we anticipate final overall survival and biomarker data from our open label phase 2a clinical trial of CAN-2409 in therapy-resistant non-small cell lung cancer patients in the very near future. This study may also trigger similar enabling work. In Q4 2025, we will also provide a clinical and biomarker update from our ongoing phase 1b clinical trial evaluating multiple doses of CAN-3110 in patients with recurrent high-grade glioma. Finally, we have also made significant progress with our preclinical programs, leveraging the enLIGHTENTM Discovery Platform."

Fourth Quarter 2024 & Recent Highlights

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CAN-2409 – Pancreatic Cancer
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Positive final survival data from the randomized controlled phase 2a clinical trial of CAN-2409 in borderline resectable pancreatic ductal adenocarcinoma (PDAC), demonstrating notable improvement in overall survival. Patients who had received experimental treatment with CAN-2409 and standard of care achieved a median overall survival of 31.4 months versus only 12.5 months observed in the control arm treated with standard of care.
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Notably, long-term survivors in the CAN-2409 arm remained alive at 66.0, 63.6, and 35.8-months post-enrollment, whereas only one patient from the control arm was still alive at the time of data cut-off (February 20, 2025). Patients in the experimental 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 U.S. Food and Drug Administration (FDA) previously granted orphan drug designation and fast track designation for CAN-2409 in borderline resectable PDAC.
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CAN-2409 – Prostate Cancer
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In December 2024, the Company reported positive topline data from its multicenter, randomized, placebo-controlled phase 3 clinical trial evaluating CAN-2409 in intermediate-to-high-risk localized prostate cancer patients. The study met its primary endpoint by demonstrating statistically significant improvement in disease-free survival (DFS) in patients who received CAN-2409 plus valacyclovir (prodrug) combined with standard of care external beam radiation therapy (n=496) compared to standard of care alone (n=249) within the intent to treat population.

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The data showed a 30% reduction in the risk for prostate cancer recurrence or death due to any cause for the CAN-2409 treatment arm compared to placebo control arm (p=0.0155), and 80.4% pathological complete responses in 2-year post-treatment biopsies after CAN-2409 administration compared to 63.6% in the control arm (p=0.0015). The safety profile of CAN-2409 was generally consistent with previous studies, with no new safety signals identified.
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This study was conducted under a Special Protocol Assessment (SPA) agreed with the FDA, meaning that safety and efficacy 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 FDA previously granted fast track designation for CAN-2409 for the treatment of localized primary prostate cancer.
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CAN-3110 – Recurrent High-Grade Glioma
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Presented updated clinical and biomarker activity data from cohort C of a phase 1b clinical trial during the 6th Annual International Oncolytic Virotherapy Conference (IOVC) in October 2024. The Principal Investigator reported ongoing improved survival compared to historical controls, with 3 out of 6 patients still alive after more than one year (12.2, 13.0 and 18.7 months, respectively) after initiation of experimental treatment with repeated administrations of CAN-3110.
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The FDA granted fast track designation and orphan drug designation to CAN-3110 for the treatment of rHGG in February and May 2024, respectively.
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CAN-3110 – Melanoma
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Presented preclinical results on the therapeutic potential of CAN-3110 in the Ras-Raf pathway altered melanoma model at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2024 Annual Meeting. CAN-3110 exhibited potent, tumor-specific cytotoxicity in human and murine melanoma cell lines with varied CDKN2A pathway alterations and Nestin expression. In vivo mouse studies showed dose-dependent inhibition of tumor growth, with regression observed in a subset (3 of 8) of tumor bearing animals treated with a high dose of CAN-3110. CAN-3110 treatment was well-tolerated in melanoma preclinical mouse models based on body weight and histopathological analysis following intra-tumoral administration.
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enLIGHTEN Discovery Platform
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Presented data on a new multimodal viral therapeutic candidate encoding IL-12 and IL-15 during IOVC 2024. Data showed the ability of the asset to induce expansion and activation of natural killer and CD8+ T cell populations, resulting in significant tumor growth inhibition and tumor regression in two different models.
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Recent Corporate Events
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In December 2024, the Company completed an underwritten public offering of 12,000,001 shares of its common stock (inclusive of the exercise of the underwriters’ option to purchase additional shares in full) at a price to the public of $6.00 per share, and pre-funded warrants to purchase up to 3,333,333 shares of its common stock at a price to the public of $5.99 per warrant with an exercise price of $0.01 per pre-funded warrant, resulting in net proceeds of approximately $85.9 million. The offering closed on December 16, 2024.

Anticipated Milestones

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Final overall survival data from phase 2a clinical trial evaluating CAN-2409 in patients with NSCLC and an inadequate response to immune checkpoint inhibitors, expected in Q1 2025.

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Biomarker and initial overall survival data from ongoing phase 1b clinical trial evaluating multiple doses of CAN-3110 in patients with rHGG, expected in Q4 2025.
Financial Results for the Year and Fourth Quarter Ended December 31, 2024

Research and Development Expenses: Research and development expenses were $4.8 million for the fourth quarter of 2024 compared to $7.3 million for the fourth quarter of 2023, and $19.3 million for the full year 2024 compared to $24.5 million for the full year 2023. The decrease was primarily due to lower regulatory, manufacturing and clinical trial costs in support of the Company’s CAN-2409 programs and lower payroll-related expenses following the corporate restructuring in the fourth quarter of 2023. Research and development expenses included a non-cash stock compensation expense of $0.8 million and $3.3 million for the fourth quarter and full year of 2024, respectively, as compared to a non-cash stock compensation expense of $0.5 million and $1.3 million for the fourth quarter and full year of 2023.

General and Administrative Expenses: General and administrative expenses were $3.3 million for the fourth quarter of 2024 compared to $3.1 million for the fourth quarter of 2023, and $14.1 million for the full year 2024 compared to $13.9 million for the full year 2023. The increase was primarily due to higher professional and consulting fees, which were partially offset by decreased payroll-related expenses following the corporate restructuring in the fourth quarter of 2023. General and administrative expenses included non-cash stock compensation expense of $0.4 million and $2.0 million for the fourth quarter and full year of 2024, respectively, as compared to a non-cash stock compensation expense of $0.5 million and $1.7 million for the fourth quarter and full year of 2023.Net Loss: Net loss for the fourth quarter of 2024 was $14.1 million compared to a net loss of $11.1 million for the fourth quarter of 2023, and included net other expense of $5.9 million and $0.8 million, respectively, related primarily to the change in the fair value of the Company’s warrant liability. Net loss for the full year 2024 was $55.2 million compared to a net loss of $37.9 million for the full year 2023 and included net other expense of $21.8 million and net other income of $0.5 million, respectively. The change from net other income in 2023 to net other expense in 2024 primarily related to the change in the fair value of the Company’s warrant liability.

Cash Position: Cash and cash equivalents as of December 31, 2024 were $102.7 million, as compared to $35.4 million as of December 31, 2023. Based on current plans and assumptions, the Company expects that its existing cash and cash equivalents will be sufficient to fund its current operating plan into the first quarter of 2027.

About CAN-2409

CAN-2409, 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 specific tumor and induce an individualized, systemic immune response against the tumor. HSV-tk is an enzyme that locally converts orally administered valacyclovir into a toxic metabolite that kills nearby cancer cells. Together, this regimen is designed to induce an individualized and specific CD8+ T cell-mediated response against the injected tumor and un-injected distant metastases for broad anti-tumor activity, based on in situ vaccination against a variety of tumor antigens. Because of its versatility, 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 other therapeutic strategies.

Currently, Candel is evaluating CAN-2409 in NSCLC and borderline resectable PDAC, in ongoing clinical trials, and has recently completed a successful phase 3 clinical trial in localized prostate cancer. CAN-2409 plus prodrug (valacyclovir) has been granted fast track designation by the FDA for the treatment of PDAC, stage III/IV NSCLC in patients who are resistant to first line PD-(L)1 inhibitor therapy and who do not have activating molecular driver mutations or have progressed on directed molecular therapy, and localized primary prostate cancer. Candel’s pivotal phase 3 clinical trial in prostate cancer was conducted under a SPA agreed with the FDA. The FDA has also granted orphan drug designation to CAN-2409 for the treatment of PDAC.

About CAN-3110

CAN-3110 is a first-in-class, replication-competent herpes simplex virus-1 (HSV-1) oncolytic viral immunotherapy candidate designed with 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.1 The Company and academic collaborators are currently evaluating the effects of multiple 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.

About the enLIGHTEN Discovery Platform

The enLIGHTEN Discovery Platform is a systematic, iterative herpes simplex virus (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. In 2022, the Company announced a discovery partnership with the University of Pennsylvania Center for Cellular Immunotherapies to create new viral immunotherapies that could enhance the efficacy of chimeric antigen receptor T cell (CAR-T) therapy in solid tumors. During the SITC (Free SITC Whitepaper) 2023 Annual Meeting and the 2023 IOVC meeting, Candel presented encouraging data on the first candidate from this platform, Alpha 201-macro-1, which was designed to interfere with the CD47/SIRP1α pathway, in mouse models of breast cancer and lung cancer. During the AACR (Free AACR Whitepaper) Annual Meeting 2024, Candel presented preclinical data, unveiling the second candidate from the enLIGHTEN Discovery Platform, a first-in-class multimodal immunotherapy candidate to induce tertiary lymphoid structures, being developed as a novel therapeutic for solid tumors. Candel presented data at the 2024 IOVC meeting. The presentation focused on a multimodal viral therapeutic candidate encoding IL-12 and IL-15, the latest asset from the platform.

On March 13, 2025 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer and autoimmune disease, reported corporate updates and reported financial results for the quarter and full year ended December 31, 2024 (Press release, Allogene, MAR 13, 2025, View Source [SID1234651122]).

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"In 2024, we focused on delivering on our bold strategy to achieve what no CAR T has accomplished before," said David Chang, M.D., Ph.D., President, Chief Executive Officer, and Co-Founder of Allogene. "Our recent data, published in the Journal of Clinical Oncology, from the Phase 1 ALPHA/ALPHA2 trials in relapsed/refractory LBCL provided compelling evidence that cema-cel can induce durable remissions comparable to approved autologous CD19 CAR T therapies. With the ALPHA3 first line consolidation trial evaluating cema-cel in LBCL now underway, the ALLO-329 IND clearance to launch the RESOLUTION trial in autoimmune disease, and completion of the Phase 1b cohort with ALLO-316 in the TRAVERSE trial in RCC, we are demonstrating that Allogene’s vision for an "off-the-shelf" cell therapy may not just be a possibility, it could be a reality in hematology, autoimmune diseases, and solid tumors. We believe 2025 will be the year allogeneic CAR T broadly begins to demonstrate its potential to surpass autologous CAR T therapy by reaching more patients with greater accessibility."

Program Updates
Cema-Cel: Pivotal ALPHA3 1L Consolidation Trial in LBCL
The pivotal Phase 2 ALPHA3 trial remains a central program for the Company. The trial, which initiated in June 2024, now has 40 sites activated and continues to generate strong enthusiasm from both community cancer centers and academic institutions.

This groundbreaking study is evaluating consolidation treatment with cema-cel as part of the 1L treatment regimen for patients with LBCL with minimal residual disease (MRD) after standard 1L treatment with R-CHOP or other chemoimmunotherapy. ALPHA3 is the first pivotal trial to offer CAR T to potentially eradicate MRD to improve cure rates in LBCL.

This innovative ALPHA3 trial will identify patients at high risk for relapse after 1L treatment by utilizing Foresight CLARITY powered by PhasED-Seq, a novel Investigational Use Only (IUO) test for MRD. This randomized trial will enroll approximately 240 patients and is designed to demonstrate a meaningful improvement in event free survival (EFS) in patients treated with cema-cel relative to patients who receive the current standard of care (observation). The lymphodepletion selection and futility analysis are anticipated around mid-2025. Efficacy analyses from the ALPHA3 trial are expected to occur in 2026 and will include an interim EFS analysis monitored by the independent Data Safety Monitoring Board (DSMB) in 1H 2026 and the data readout of the primary EFS analysis around YE 2026. A potential biologics license application (BLA) submission is targeted for 2027.

In February 2025, the Journal of Clinical Oncology published data from the Company’s Phase 1 ALPHA/ALPHA2 trials of cema-cel in relapsed/refractory LBCL, demonstrating durable responses comparable to approved autologous CD19 CAR T therapies. In addition, the Company announced that it had expanded its strategic partnership with Foresight Diagnostics to support the development of Foresight Diagnostics’ MRD assay as a companion diagnostic in the EU, UK, Canada and Australia in support of Allogene’s clinical development of cema-cel.

ALLO-329: CD19/CD70 Dual CAR with Dagger Technology in AID
ALLO-329 offers a novel approach to treating autoimmune diseases as the first allogeneic CD19/CD70 dual CAR T product specifically designed to target CD19+ B-cells and CD70+ activated T-cells, both of which are key players in autoimmune diseases. The investigational product utilizes CRISPR-based site-specific integration and incorporates the Company’s clinically validated Dagger technology, which aims to reduce or eliminate the need for lymphodepletion, believed to be a potentially significant obstacle to the wider adoption of CAR T therapies in autoimmune indications.

In January 2025, the FDA cleared the IND application to initiate clinical trials of ALLO-329 in patients with systemic lupus erythematosus, including lupus nephritis, idiopathic inflammatory myopathies, and systemic sclerosis. The innovative design of the RESOLUTION basket trial includes two distinct lymphodepletion arms: one using a dose of cyclophosphamide alone and another that eliminates lymphodepletion entirely. The trial is scheduled to begin in mid-2025, aiming to provide proof-of-concept around year-end 2025.

During the fourth quarter, the Company presented pre-clinical data for ALLO-329, at the American College of Rheumatology’s annual meeting, showcasing its potential to address both B-cell and T-cell dysfunction in autoimmune diseases.

ALLO-316: TRAVERSE Trial in RCC
ALLO-316 is the only allogeneic CAR T therapy to show potential in solid tumors. In Q4 2024, the Company announced positive Phase 1 data from the TRAVERSE trial highlighting a manageable safety profile and significant anti-tumor activity of ALLO-316 in heavily pretreated patients with advanced or metastatic RCC.

Enrollment has completed in the Phase 1b expansion cohort, which is evaluating safety and efficacy of ALLO-316 at DL2 (80M CAR T cells). As the product that brought clinical validation of the Dagger effect, clinical activity of ALLO-316 at this dose level is achieved without ALLO-647-enhanced lymphodepletion and follows a standard lymphodepletion regimen with fludarabine and cyclophosphamide. Data from this cohort is planned for mid-2025.

Also during the quarter, the Company announced that it had received Regenerative Medicine Advanced Therapy (RMAT) designation for ALLO-316 for adult patients with advanced or metastatic RCC based on the Phase 1 clinical data from the TRAVERSE trial.

2024 Fourth Quarter and Year-End Financial Results

Research and development expenses were $45.0 million for the fourth quarter of 2024, which includes $5.6 million of non-cash stock-based compensation expense. For the full year of 2024, research and development expenses were $192.3 million, which includes $20.4 million of non-cash stock-based compensation expense.
General and administrative expenses were $15.5 million for the fourth quarter of 2024, which includes $7.3 million of non-cash stock-based compensation expense. For the full year of 2024, general and administrative expenses were $65.2 million, which includes $31.3 million of non-cash stock-based compensation expense.
Net loss for the fourth quarter of 2024 was $59.9 million, or $0.28 per share, including non-cash stock-based compensation expense of $12.9 million. For the full year of 2024, net loss was $257.6 million, or $1.32 per share, including non-cash stock-based compensation expense of $51.7 million and $15.7 million in non-cash impairment of long-lived asset expense.
The Company had $373.1 million in cash, cash equivalents, and investments as of December 31, 2024.
Based on its cash, cash equivalents and investments as of December 31, 2024, the Company continues to expect its cash runway to fund operations into the second half of 2026. Guidance for 2025 is an expected decrease in cash, cash equivalents, and investments of approximately $170 million. GAAP Operating Expenses are expected to be approximately $250 million, including estimated non-cash stock-based compensation expense of approximately $50 million. These estimates exclude any impact from potential business development activities.

Conference Call and Webcast Details
Allogene will host a live conference call and webcast today at 2:00 p.m. PT / 5:00 p.m. ET to discuss financial results and provide a business update. If you would like the option to ask a question on the conference call, please use this link to register. Upon registering for the conference call, you will receive a personal PIN to access the call, which will identify you as the participant and allow you the option to ask a question. The listen-only webcast will be made available on the Company’s website at www.allogene.com under the Investors tab in the News and Events section. Following the live audio webcast, a replay will be available on the Company’s website for approximately 30 days.

On March 13, 2025 ChromaDex Corp. (NASDAQ:CDXC), the global authority on NAD+ (nicotinamide adenine dinucleotide) with a focus on the science of healthy aging, reported that it will change its corporate name to Niagen Bioscience, Inc. and trade under the new Nasdaq symbol "NAGE" effective at stock market open on Wednesday, March 19, 2025 (Press release, ChromaDex, MAR 13, 2025, View Source [SID1234651123]).

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As part of this transition, the Company will deploy a follow-up announcement with additional updates regarding the name change, rebrand, and future initiatives.

No action is required by existing shareholders with respect to the ticker symbol change. The Company’s common stock will continue to be listed on Nasdaq and the CUSIP will remain unchanged.

For additional information on ChromaDex, visit www.chromadex.com.

On March 12, 2025 Assertio Holdings, Inc. ("Assertio" or the "Company") (Nasdaq: ASRT) reported financial results for the fourth quarter and full year ended December 31, 2024 (Press release, Assertio Holdings, MAR 12, 2025, View Source [SID1234654208]).

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Said Brendan O’Grady, Chief Executive Officer, "In line with our strategy for Assertio’s long-term growth, 2024 was a year of stabilization as we transitioned to Rolvedon as our primary asset. We enhanced our leadership team and board with additional expertise in legal, commercial, and strategy areas, optimized our cost structure, and strengthened our balance sheet with over $26 million in cash flow generated by the performance of our assets.

"We expect 2025 will be a transformational year focused on initiatives designed to drive revenue growth in Rolvedon and Sympazan by investing to unlock new opportunities, continuing to manage our legal exposure and associated costs, while simplifying our structure.

"We are also actively pursuing our acquisition strategy, seeking to deploy our balance sheet into appropriate commercial assets that fit our model, enhance our scale and better position ourselves for near-term growth. We remain diligent in these efforts with regard to finding the proper fit and pricing of assets that can deliver results within our targeted metrics as we work to build on the commercial platform at Assertio."