NanOlogy, LLC CEO David J. Arthur Discusses Their PURCISION™ Technology Advancing Intratumoral Therapy to Treat Cancer

On February 26, 2026 CEOCFO Magazine, an independent business and investor publication that highlights important technologies and companies, reported an interview with David J. Arthur, CEO, of Fort Worth, Texas based NanOlogy, LLC advancing their PURCISION technology platform aimed at improving the treatment of cancer without increasing toxicity.

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David J. Arthur, during the interview with CEOCFO’s Senior Editor Lynn Fosse, addressing the concept behind NanOlogy said, "NanOlogy is a clinical-stage oncology company advancing a technology platform aimed at improving the treatment of cancer without increasing toxicity. The technology, called PURCISION, forms particles of pure cancer drugs optimized for intratumoral (IT) delivery. These particles are delivered directly to the site of the tumor, where they continuously deliver high local concentration of drug to the tumor over time, with minimal systemic toxicity. NanOlogy has established feasibility of the PURCISION technology in many small molecules and has studied three intratumorally delivered investigational drugs preclinically or clinically in several solid tumors. The technology, supporting data, and team all attracted me to take on the role of CEO as I believe my background and experience can help position the company to benefit cancer patients and create long term value to shareholders. I think NanOlogy has got to be one of the more attractive companies out there right now."

On the need to improve the treatment of solid tumors, David J. Arthur told Lynn, "A significant unmet need in oncology is to improve the treatment of solid tumors. Solid tumors are very hard to treat and rational combinations including chemotherapies, and newer agents like targeted therapies and immunotherapies, will remain standard of care (SOC) for the foreseeable future. Research has shown that chemo and targeted therapies help kill the tumor and elicit an immune response, called "immune priming", to help improve solid tumor response to immunotherapy.

Over the years, researchers have been working on many methods to target the delivery of cancer drugs to help improve solid tumor response. Targeted therapies given systemically are an example but have not lived up to their promise because of off-target toxicities and other limitations."

As for how their technology approach is different, David J. Arthur shared, "Instead of systemic administration, the PURCISION technology is designed to be given locally to directly kill the primary tumor or tumors and prime the immune system to increase solid tumor response to newer SOC therapies. Our proprietary technology uniquely uses supercritical fluid carbon dioxide as an antisolvent to form what we have come to characterize as large surface area microparticles, or "LSAMs", of pure drug optimized for intratumoral delivery. The microparticles retain a particle size that is sufficient for tumor retention but with a huge increase in surface area that allows for high local drug release over time. LSAMs are covered by a composition of matter patent forming the foundation of more than 100 issued patents filed globally protecting composition, use, formulation, and technology."

Asked where they are in the development process, David J. Arthur replied, "There are many different types of solid tumors, and most are now accessible because of advancements in imaging and advancements in interventional procedures over the last decade. One of the things that excited me about NanOlogy when I came onboard was the breadth of clinical experience that they have already achieved with their LSAM investigational drugs. On two LSAM assets, NanOlogy has run seven clinical trials across six different solid tumors including bladder, lung, pancreas, prostate, ovarian, and peritoneal cancers. We are now talking with Strategic Pharma and other groups to advance those assets further in clinical development in prioritized indications."

Pointing to another asset they have in development, David J. Arthur offered, "Another asset we are excited about is the development of cisplatin into LSAM-Cisplatin. Cisplatin is a chemotherapy that has been around for a while with many uses but has terrible side effects when given systemically. We have developed a clinical formulation of LSAM-Cisplatin and are nearing completion of preclinical studies with our lead indication for a rare devastating pediatric brainstem tumor called diffuse intrinsic pontine glioma (DIPG). This is a devastating, highly lethal cancer in children, with typical onset between the ages of two and ten. There is no treatment other than radiation. Unfortunately, the median survival for these children after diagnosis is only 10 months."

As for their approach to DIPG, David J. Arthur continued, "A key problem is that DIPG is deep in the brain. It is very difficult to get systemically administered drugs through the blood brain barrier to the tumor, and these tumors are inoperable because of their location. But recent advances have allowed us to use a highly precise MRI guided targeting system, to inject LSAM-Cisplatin directly into the tumor. We are hopeful that delivery LSAM-Cisplatin directly to the tumor will offer hope for children and families facing this horrible disease and that LSAM-Cisplatin could become one of the first approved medicines with significant benefit for the treatment of DIPG."

Addressing emerging interest in Intratumoral Therapy, David J. Arthur told CEOCFO, "Intratumoral therapy is rapidly gaining momentum as a potential important part of the treatment of solid tumors – in early disease to prevent or delay progression and in late disease, combined with newer systemic agents, to improve response without the severe stacked toxicities associated with systemic combinations. We are beginning to see the proverbial hockey stick in interest emerge – whereas only a few clinical trials involving IT modalities were underway a few years ago, almost 200 clinical trials are currently underway. Large pharma is beginning to take note, too, with companies like J&J already significantly investing in the space. NanOlogy is a leader in IT therapy aimed at improving solid tumor response without increasing toxicity with growing evidence in support of this aim."

(Press release, NanOlogy, FEB 26, 2026, View Source;utm_medium=rss&utm_campaign=nanology-llc-ceo-david-j-arthur-discusses-their-purcision-technology-advancing-intratumoral-therapy-to-treat-cancer [SID1234663127])

Curium Announces Pharmacokinetics and Dosimetry Data for Investigational Lutetium-177 Zadavotide Guraxetan in Metastatic Castration-Resistant Prostate Cancer at ASCO GU 2026

On February 26, 2026 Curium, a world leading nuclear medicine company dedicated to using cutting-edge technology and innovative science to personalize diagnoses and treatments for patients with cancer, reported the first dosimetry and pharmacokinetics (PK) data from a substudy of the ongoing pivotal Phase 3 ECLIPSE clinical trial (NCT05204927).

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The Phase 3 ECLIPSE clinical trial evaluates lutetium-177 (Lu-177) zadavotide guraxetan (a proprietary formulation of 177Lu-PSMA-I&T), an investigational prostate-specific membrane antigen (PSMA)-targeted radioligand therapy, for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) who have progressed on prior androgen receptor pathway inhibitor (ARPI). The data will be presented in a poster at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO GU) taking place 26-28 February, 2026, in San Francisco, California.

The nonrandomized PK/dosimetry substudy (n=26) was conducted as part of the ECLIPSE trial to evaluate the biodistribution and radiation absorbed dose of Lu-177 zadavotide guraxetan to organs of interest.

Sakir Mutevelic, MD, Curium’s Chief Medical Officer said: "These data represent the first published dosimetry data for our investigational formulation of Lu-177 zadavotide guraxetan, with projected mean cumulative renal doses remaining low for a six-cycle treatment regimen, thus supporting a protocol amendment to increase from a maximum of four doses to six in the ECLIPSE trial. We will continue to evaluate the ECLIPSE clinical trial data with the goal of bringing this potential therapy to market for those living with mCRPC. This reinforces our long-term vision to treat 80 percent of cancers within the next 10-15 years."

Frankis Almaguel, MD, PhD, Assistant Professor, Medicine, Hematology/Oncology, Loma Linda University Health Cancer Center, and presenting author said: "These data reinforce the clinical utility of using dosimetry data to inform clinical trial protocol design, as well as identify organs at highest risk of radiation exposure."

A poster, Pharmacokinetics and Dosimetry of Lutetium Lu 177 Zadavotide Guraxetan in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC): Results From the ECLIPSE Sub-study (Abstract #174), will be presented on Thursday, 26 February in Poster Session A: Prostate Cancer. The abstract is available here.

ASCO GU attendees can learn more about Curium by visiting booth 11 during the symposium.

(Press release, Curium Pharma, FEB 26, 2026, View Source [SID1234663066])

Pacira BioSciences Reports Fourth Quarter and Full-Year 2025 Financial Results

On February 26, 2026 Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to deliver innovative, non-opioid pain therapies to transform the lives of patients, reported financial results for the fourth quarter and full-year of 2025.

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"2025 was a year of disciplined execution for Pacira. With the launch of our 5×30 strategy, we reignited momentum across the business and delivered strong, measurable progress. Our products benefitted more than 2.5 million patients, generated $726 million in revenue, and achieved the highest gross margins in our company’s history. Together, these results clearly validate the impact and promise of our 5×30 strategy," said Frank D. Lee, chief executive officer of Pacira BioSciences.
"Our performance continues to be led by EXPAREL, which is benefitting from expanding reimbursement, growing commercial adoption, and strengthened intellectual property providing protection into the 2040s. We further extended our commercial reach through strategic collaborations, while advancing clinical programs positioned to deliver a data-rich year. Pacira enters 2026 stronger than ever as we continue to redefine what is possible in innovative non-opioid pain management," continued Mr. Lee.

2025 Fourth Quarter and Full-Year Financial Highlights

•Fourth quarter revenues of $196.9 million and full-year revenues of $726.4 million.
•Fourth quarter GAAP net income of $1.6 million or $0.04 per basic and diluted share and full-year GAAP net income of $7.0 million or $0.16 per basic and diluted share.
•Fourth quarter adjusted EBITDA of $38.7 million and full-year adjusted EBITDA of $186.5 million.
•Repurchased 2.0 million shares of common stock at an average price of $24.94, for a cost of $50.0 million in the fourth quarter, bringing the full year 2025 to 5.9 million shares of common stock repurchased for a cost of $150.0 million.
See "Non-GAAP Financial Information" below.
Recent Business Highlights
•Enhanced Board of Directors with Appointment of Samit Hirawat, M.D. In January 2026, the company announced the appointment of Samit Hirawat, M.D., to its Board of Directors, bringing more than 25 years of clinical development and industry expertise. This appointment increases the size of the company’s Board of Directors to 10 members. Most recently, Dr. Hirawat served as Chief Medical Officer, Executive Vice President, and Head of Global Drug Development at Bristol

Myers Squibb, where he oversaw the worldwide clinical development portfolio and advanced multiple transformative therapies across therapeutic areas.
•Strategic Partnership with LG Chem to Bring EXPAREL to Select Asian-Pacific Markets. In January 2026, the company announced an agreement with LG Chem designed to expand access to opioid-sparing postsurgical pain control for patients in select Asian-Pacific markets. Through this partnership, LG Chem has the exclusive rights to commercialize EXPAREL in the region. Under the terms of the agreement, Pacira received an upfront payment, will supply EXPAREL product and receive a transfer price as well as tiered royalties on future commercial sales. LG Chem plans to file for marketing authorizations in South Korea and Thailand in 2026.
Fourth Quarter 2025 Financial Results
•Total revenues were $196.9 million in the fourth quarter of 2025, a 5 percent increase over the $187.3 million reported for the fourth quarter of 2024.
•EXPAREL net product sales were $155.8 million in the fourth quarter of 2025, a 5 percent increase over the $147.7 million reported for the fourth quarter of 2024.
•ZILRETTA net product sales were $33.0 million in the fourth quarter of 2025, essentially flat versus the $33.1 million reported for the fourth quarter of 2024.
•Fourth quarter 2025 iovera° net product sales were $7.0 million, an 8 percent increase over the $6.5 million reported in the fourth quarter of 2024.
•Total operating expenses were $194.5 million in the fourth quarter of 2025, versus the $162.5 million reported for the fourth quarter of 2024.
•Research and development (R&D) expenses were $37.5 million in the fourth quarter of 2025, compared to $23.9 million in the fourth quarter of 2024. The company’s fourth quarter 2025 R&D expenses included a $5.0 million upfront payment for the in-licensing of PCRX-2002 (previously known as AMT-143) from AmacaThera, Inc.
•Selling, general and administrative (SG&A) expenses were $101.6 million in the fourth quarter of 2025, compared to $79.6 million in the fourth quarter of 2024. The company’s fourth quarter 2025 SG&A expenses were impacted by a number of unanticipated costs associated with business development due diligence and litigation.
•GAAP net income was $1.6 million, or $0.04 per basic and diluted share in the fourth quarter of 2025, compared to $16.0 million, or $0.35 per basic share and $0.34 per diluted share in the fourth quarter of 2024.
•Non-GAAP net income was $24.4 million, or $0.58 per basic share and $0.57 per diluted share in the fourth quarter of 2025, compared to $44.3 million, or $0.96 per basic share and $0.91 per diluted share in the fourth quarter of 2024.
•Adjusted EBITDA was $38.7 million in the fourth quarter of 2025, compared to $62.5 million in the fourth quarter of 2024.
•Pacira ended the fourth quarter of 2025 with cash, cash equivalents and available-for-sale investments ("cash") of $238.4 million.
•Pacira had 42.5 million basic and 43.0 million diluted weighted average shares of common stock outstanding in the fourth quarter of 2025.
See "Non-GAAP Financial Information" below.

Full-Year 2025 Financial Results
•Total revenues were $726.4 million in 2025, a 4 percent increase over the $701.0 million reported in 2024.
•EXPAREL net product sales were $575.1 million in 2025, a 5 percent increase over the $549.0 million reported in 2024.
•ZILRETTA net product sales were $116.6 million in 2025, a 1 percent decrease versus the $118.1 million reported in 2024.
•Full-year iovera° net product sales were $24.2 million, a 6 percent increase over the $22.8 million reported in 2024.
•Total operating expenses were $707.2 million in 2025, compared to $774.3 million in 2024. Included within 2024 is a goodwill impairment of $163.2 million.
•R&D expenses were $117.3 million in 2025, compared to $81.6 million in 2024. The company’s 2025 R&D expenses included a $5.0 million upfront payment for the in-licensing of PCRX-2002 from AmacaThera, Inc.
•SG&A expenses were $368.8 million in 2025, compared to $294.1 million in 2024. The company’s 2025 SG&A expenses were impacted by a number of unanticipated costs associated with business development due diligence and litigation.
•GAAP net income was $7.0 million, or $0.16 per basic and diluted share in 2025, compared to a GAAP net loss of $99.6 million, or $2.15 per basic and diluted share in 2024. Included in the GAAP net loss in 2024 was a $163.2 million impairment of goodwill based upon an assessment that the then-fair value of goodwill was less than its carrying value.
•Non-GAAP net income was $122.3 million, or $2.74 per basic share and $2.65 per diluted share in 2025, compared to $157.7 million, or $3.41 per basic share and $3.20 per diluted share in 2024.
•Adjusted EBITDA was $186.5 million in 2025, compared to $223.9 million in 2024.
•Pacira had 44.6 million basic and 45.0 million diluted weighted average shares of common stock outstanding in 2025.
•For non-GAAP measures, Pacira had 46.7 million and 50.2 million diluted weighted average shares of common stock outstanding in 2025 and 2024, respectively.
See "Non-GAAP Financial Information" below.
Share Repurchase Program
During the fourth quarter of 2025, the company repurchased 2.0 million shares of its common stock at an average price of $24.94, through open market transactions for $50.0 million, bringing the company’s total shares repurchased in 2025 to 5.9 million for $150.0 million. At December 31, 2025, the company had 41.1 million shares of common stock outstanding and $150.0 million remaining on its current share repurchase authorization, which expires December 31, 2026.

2026 Financial Guidance
Today the company is providing full-year 2026 financial guidance as follows:
•EXPAREL net product sales of $600 to $620 million;
•Total revenue of $745 million to $770 million;
•Non-GAAP gross margin of 77 to 79 percent;
•Non-GAAP R&D expense of $105 million to $115 million;
•Non-GAAP SG&A expense of $320 million to $340 million; and
•Stock-based compensation of $54 million to $62 million.
See "Non-GAAP Financial Information" below.
Today’s Conference Call and Webcast Reminder
The Pacira management team will host a conference call to discuss the company’s financial results and recent developments today, Thursday, February 26, 2026, at 4:30 p.m. ET. For listeners who wish to participate in the question-and-answer session via telephone, please pre-register at investor.pacira.com/upcoming-events. All registrants will receive dial-in information and a PIN allowing them to access the live call. In addition, a live audio of the conference call will be available as a webcast. Interested parties can access the event through the "Events" page on the Pacira website at investor.pacira.com.

(Press release, Pacira Pharmaceuticals, FEB 26, 2026, View Source;991.htm [SID1234663085])

Relay Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Outlines Anticipated 2026 Milestones

On February 26, 2026 Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage, small molecule precision medicine company developing potentially life-changing therapies for patients living with cancer and genetic disease, reported fourth quarter and full year 2025 financial results and 2026 guidance.

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"Our focus on disciplined execution to date has strengthened the foundation of Relay, aligning our organization to support long-term success. In 2026, Relay is entering a pivotal period defined by multiple upcoming clinical milestones across our zovegalisib program, which recently received Breakthrough Therapy designation from the FDA," said Sanjiv Patel, M.D., President and Chief Executive Officer of Relay Therapeutics. "We anticipate presenting Phase 1/2 breast cancer data at the upcoming ESMO (Free ESMO Whitepaper) TAT Congress, reporting initial data in PIK3CA-driven vascular anomalies, and providing updates on our breast cancer triplet data and frontline Phase 3 development plans. These milestones position us to deliver meaningful updates in areas with significant unmet need for patients, while continuing to build momentum toward potential commercialization."

Anticipated 2026 Milestones

Breast Cancer
Abstract accepted to European Society for Medical Oncology Targeted Anticancer Therapies (ESMO TAT) Congress 2026 for initial data from the Phase 1/2 ReDiscover trial of zovegalisib (RLY-2608) + fulvestrant at the Phase 3 dose
The abstract is focused on 57 patients treated at the recommended Phase 3 dose of 400mg twice daily (BID) fed that have HR+/HER2-, PI3Kα-mutated metastatic breast cancer and have previously been treated with a CDK4/6 inhibitor
Oral Proffered Paper Session: Dose optimization of zovegalisib, a novel PI3Kα inhibitor, in patients with PIK3CA-mutant HR+/HER2- advanced breast cancer: results from the first-in-human study to support the recommended Phase 3 dose
Location/Date/Time: Paris, France; Monday, March 16, 2026; 4:00 p.m. CET/11:00 a.m. ET
Triplet clinical data and frontline Phase 3 study design plan anticipated in 2026
Vascular Anomalies
Initial clinical data disclosure from the Phase 1 ReInspire trial in PIK3CA-driven vascular anomalies planned for 1H 2026
The pediatric cohort in the trial recently opened ahead of schedule due to faster than expected enrollment and the company anticipates reporting on approximately 20 patients at time of disclosure
Zovegalisib 2025 Highlights

Breast Cancer
Continued execution of the Phase 3 ReDiscover-2 trial of zovegalisib + fulvestrant in PI3Kα-mutated, CDK4/6 pre-treated, HR+/HER2- advanced breast cancer
Presented data from Phase 1/2 ReDiscover trial of zovegalisib + fulvestrant at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2025 Annual Meeting and the 2025 San Antonio Breast Cancer Symposium (SABCS). SABCS summary with a data cut-off date of October 15, 2025:
The median progression free survival (PFS) was 10.3 months for all patients (n=52).
Among the total of 31 patients with measurable disease, objective response rate (ORR) was 39%. For second line (2L) patients, median PFS was 11.4 months and ORR was 47%. Median follow-up was 20.2 months.
Efficacy was generally consistent across other subsets of patients. For patients who received prior SERD, median PFS was 11.4 months and ORR was 44% (7/16), and for patients who had a detectable ESR1 mutation at baseline, median PFS was 8.8 months and ORR was 60% (6/10).
The overall tolerability profile remained consistent with mutant-selective PI3Kα inhibition, with treatment-related adverse events that were mostly low-grade, manageable and reversible.
Triplet cohorts of zovegalisib in combination with atirmociclib, ribociclib, or palbociclib are ongoing to inform frontline Phase 3 preferred regimen and plans
Vascular Anomalies
Continued execution of Phase 1 ReInspire trial of zovegalisib in PIK3CA-driven vascular anomalies
Fourth Quarter and Full Year 2025 Financial Results

Cash, Cash Equivalents and Investments: As of December 31, 2025, cash, cash equivalents, and investments totaled $554.5 million compared to approximately $781.3 million as of December 31, 2024. The company expects its current cash, cash equivalents, and investments will be sufficient to fund its operating expenses and capital expenditure requirements into 2029.

Revenue: Revenue was $7.0 million for the fourth quarter of 2025, as compared to $0 for the fourth quarter of 2024. Revenue was $15.4 million for the full year 2025, as compared to $10.0 million for the full year 2024. The revenue recognized in the current year periods was under our Exclusive License Agreement with Elevar Therapeutics, Inc. The revenue recognized in the prior year periods was under our Collaboration and License Agreement with Genentech, Inc.

R&D Expenses: Research and development expenses were $55.4 million for the fourth quarter of 2025, as compared to $68.1 million for the fourth quarter of 2024. Research and development expenses were $261.4 million for the full year 2025, as compared to $319.1 million for the full year 2024. The decreases were primarily due to the series of strategic choices to streamline the research organization throughout 2024 and 2025, as well as decreases in costs incurred on continued development of lirafugratinib after execution of the Exclusive License Agreement with Elevar Therapeutics, Inc. in December 2024, offset by increases in costs related to the ReDiscover-2 trial and ReInspire trial.

G&A Expenses: General and administrative expenses were $12.2 million for the fourth quarter of 2025, as compared to $16.9 million for the fourth quarter of 2024. General and administrative expenses were $56.7 million for the full year 2025, as compared to $76.6 million for the full year 2024. The decreases were primarily due to decreases in stock compensation expense and other employee costs.

Net Loss: Net loss was $54.9 million for the fourth quarter of 2025, or a net loss per share of $0.32, as compared to a net loss of $76.0 million for the fourth quarter of 2024, or a net loss per share of $0.45. Net loss was $276.5 million for the full year 2025, or a net loss per share of $1.61, as compared to a net loss of $337.7 million for the full year 2024, or a net loss per share of $2.36.

About Zovegalisib

Zovegalisib is the lead program in Relay Therapeutics’ efforts to discover and develop mutant selective inhibitors of PI3Kα, the most frequently mutated kinase in all cancers and all vascular anomalies. Zovegalisib has the potential, if approved, to address a significant portion of the approximately 140,000 patients with HR+/HER2- breast cancer with a PI3Kα mutation and the estimated 170,000 patients with vascular anomalies driven by a PI3Kα mutation per year in the United States, one of the largest patient populations for a precision medicine.

Traditionally, the development of PI3Kα inhibitors has focused on the active, or orthosteric, site. The therapeutic index of orthosteric inhibitors is limited by the lack of clinically meaningful selectivity for mutant versus wild-type (WT) PI3Kα and off-isoform activity. Toxicity related to inhibition of WT PI3Kα and other PI3K isoforms results in sub-optimal inhibition of mutant PI3Kα with reductions in dose intensity and frequent discontinuation. The Dynamo platform enabled the discovery of zovegalisib, the first known allosteric, pan-mutant, and isoform-selective PI3Kα inhibitor, designed to overcome these limitations. Relay Therapeutics solved the full-length cryo-EM structure of PI3Kα, performed computational long time-scale molecular dynamic simulations to elucidate conformational differences between WT and mutant PI3Kα, and leveraged these insights to support the design of zovegalisib. Zovegalisib is currently being evaluated in multiple metastatic breast cancer studies and a first-in-human study designed to treat patients with PIK3CA (PI3Kα) mutation driven vascular anomalies.

(Press release, Relay Therapeutics, FEB 26, 2026, View Source [SID1234663101])

Delcath Systems Reports Fourth Quarter and Full Year 2025 Results

On February 26, 2026 Delcath Systems, Inc. (Nasdaq: DCTH) ("Delcath" or the "Company"), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported financial results and business highlights for the fourth quarter and full year-ended December 31, 2025.

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Fourth Quarter and Full Year 2025 Financial Results

Total fourth quarter and full year revenue of $20.7 million and $85.2 million, respectively
HEPZATO KIT fourth quarter and full year revenue of $19.0 million and $78.8 million, respectively
CHEMOSAT fourth quarter and full year revenue of $1.7 million and $6.4 million, respectively
Gross margins of 85% for the fourth quarter and 86% for the full year
Fourth quarter net loss of $1.9 million and full year net income of $2.7 million
Non-GAAP positive adjusted EBITDA for the fourth quarter and full year of $2.4 million and $25.1 million, respectively
Repurchased 628,572 common shares for $6.0 million through December 31, 2025 under the approved $25 million Share Buyback Program
As of December 31, 2025, the Company had approximately $91.0 million of cash and short-term investments and no debt
Business Highlights

Currently 28 active centers
Approximately 140% growth in HEPZATO procedure volume in 2025 compared to 2024
Announced the publication of additional results from the FOCUS study, "Subgroup Analyses of the Phase 3 FOCUS Study of Melphalan/Hepatic Delivery System in Patients with Unresectable Metastatic Uveal Melanoma" in Journal of Cancer Research and Clinical Oncology
Announced the publication of results from multiple studies by independent investigators, including:
Results from the Phase 2 CHOPIN trial sponsored by Leiden University Medical Center evaluating CHEMOSAT with ipilimumab and nivolumab in metastatic uveal melanoma at the 2025 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Congress showing a significant improvement in one-year progression-free survival versus CHEMOSAT alone
A long-term retrospective study conducted by researchers at the University Hospital Tübingen, Germany, "Characterization of long-term survivors with liver metastases from uveal melanoma diagnosed between 2005 and 2021", in International Journal of Cancer
A long-term retrospective study conducted by researchers at the Asklepios Hospital Barmbek, Germany, "Survival Outcome After Percutaneous Hepatic Perfusion with High-Dose Melphalan for Liver-Dominant Metastatic Uveal Melanoma: A 10-Year Single-Center Experience" in Cancers
"2025 was a pivotal year in which we delivered robust procedure-volume growth, positive operating cashflow and successfully navigated temporary headwinds to stabilize the HEPZATO revenue base in the fourth quarter," said Gerard Michel, President and Chief Executive Officer of Delcath "With 28 active treatment centers now delivering therapy and compelling CHOPIN data demonstrating clear clinical benefit when PHP is sequenced with checkpoint inhibitors, we enter 2026 with strong momentum. Through continued site activations, commercial expansion, and heightened physician awareness of the CHOPIN results, we expect accelerated adoption and utilization that will drive long-term value for patients and shareholders alike."

2026 Full Year Financial Guidance

The Company’s financial outlook for fiscal year 2026:

Total CHEMOSAT and HEPZATO KIT revenue to be at least $100 million, reflecting an increase in HEPZATO KIT volume of at least 20% over 2025, and
Gross margins in the range of 84% to 87%.
Fourth Quarter and Full Year 2025 Results

Total revenue for the quarter ended December 31, 2025 was $20.7 million compared to $15.1 million for the same period in the prior year. Revenue in the quarter includes sales of $19.0 million of HEPZATO in the U.S. and $1.7 million of CHEMOSAT in Europe.

Total revenue for the year-ended December 31, 2025 was $85.2 million compared to $37.2 million for the same period in the prior year. Revenue in 2025 includes sales of $78.8 million of HEPZATO in the U.S. and $6.4 million of CHEMOSAT in Europe.

Research and development expenses for the quarter and year-ended December 31, 2025, were $9.4 million and $29.2 million, respectively compared to $2.9 million and $13.9 million for the same periods in the prior year. The increase is primarily due to costs associated with expanding the clinical team including share-based compensation expense related to an increase in headcount and initiation of the Phase 2 clinical trial evaluating HEPZATO in combination with standard of care for mCRC and mBC. In 2024, these costs are primarily related to medical affairs and regulatory costs associated with the approved products.

Selling, general and administrative expenses for the quarter and year-ended December 31, 2025, were $10.5 million and $43.5 million, respectively compared to $7.0 million and $29.6 million for the same periods in the prior year. The increase is primarily due to continued commercial expansion activities including marketing-related expenses and additional personnel on the commercial team. In addition, the increase in personnel along with higher grant date exercise prices has increased the share-based compensation expense.

Net loss for the quarter ended December 31, 2025 was $1.9 million and net income for the full year was $2.7 million, compared to net loss of $3.4 million and $26.4 million for the same periods in the prior year.

Non-GAAP positive adjusted EBITDA for the quarter and year-ended December 31, 2025 was $2.4 million and $25.1 million compared to adjusted EBITDA gain of $4.6 million and loss of $2.5 million for the same periods in the prior year. A table reconciling non-GAAP measures is included in this press release for reference.

As of December 31, 2025, the Company had $91.0 million in cash and investments, and no debt.

Conference Call Information

To participate in this event, dial in approximately 5 to 10 minutes before the beginning of the call.

Event Date: Thursday, February 26, 2026
Time: 8:30 AM Eastern Time

(Press release, Delcath Systems, FEB 26, 2026, View Source [SID1234663067])