On February 27, 2025 Novocure (NASDAQ: NVCR) reported financial results for the quarter and full year ended December 31, 2024 (Press release, NovoCure, FEB 27, 2025, View Source [SID1234650731]). Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer by developing and commercializing its innovative therapy, Tumor Treating Fields (TTFields).

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"Entering 2024, our team was focused on three objectives – grow our core business treating glioblastoma, launch in non-small cell lung cancer, and deliver on the promise of our clinical pipeline. I am proud to say we have successfully achieved all three goals," said Ashley Cordova, CEO Novocure. "2025 is a defining year for Novocure as we enter a new era with a multi-indication platform propelled by positive Phase 3 data in three indications – one FDA-approved and two advancing toward regulatory submission. We believe we are positioned to transform patient outcomes across multiple high-need oncology indications."

Financial updates for the fourth quarter and full year ended December 31, 2024:

Total net revenues for the year were $605.2 million, an increase of 19% year-over-year, primarily driven by continued launch success in France for Optune Gio for glioblastoma (GBM) and improved approval rates in the U.S., which are now reflected in our revenue baseline. 2025 net revenue growth is expected to reflect growth in Optune Gio active patients. As the GBM business reaches maturity we expect to continue to grow at a low mid-single digit rate this year.
Total net revenues for the quarter were $161.3 million, an increase of 21% year-over-year.
The U.S., Germany, France and Japan contributed $107.2 million, $17.4 million, $15.7 million and $8.5 million in quarterly net revenues, respectively, with our other active markets contributing $10.4 million.
Revenue in Greater China from Novocure’s partnership with Zai Lab totaled $2.0 million.
Improved approval rates in the U.S. resulted in $8.3 million of increased net revenue from prior period claims during the quarter, which we believe should not be considered in our 2025 baseline. This is in addition to the $14.0 million of increased revenue from prior period claims disclosed through the third quarter.
Gross margin for the quarter was 79%. In 2025, we expect our gross margins will be impacted by current and future product enhancements, such as the U.S. launch of our Head Flexible Electrode (HFE) transducer arrays for use with Optune Gio, and the launch of Optune Lua in metastatic non-small cell lung cancer (NSCLC). Our current analysis of the global tariff environment leads us to believe there should not be a material impact to margins in the short term and we are actively working to mitigate any potential impacts in the medium-to-long term.
Research, development and clinical studies expenses for the quarter were $51.2 million, a decrease of 6% from the same period in 2023. Clinical trial expenses can fluctuate quarter-to-quarter depending on the number of clinical trials actively underway, amount of clinical research organization services delivered and clinical materials procured.
Sales and marketing expenses for the quarter were $67.4 million, an increase of 14% from the same period in 2023. This primarily reflects the expansion of our NSCLC sales force as we launch in this new indication.
General and administrative expenses for the quarter were $72.5 million, an increase of 84% from the same period in 2023. This was primarily driven by $36.1 million in one-time stock-based compensation expenses related to U.S. Food and Drug Administration (FDA) approval of our metastatic NSCLC indication.
Net loss for the quarter was $65.9 million with loss per share of $0.61.
Adjusted EBITDA* for the quarter was $2.6 million, an increase of $34.1 million from the same period in 2023. This increase was primarily driven by revenue growth and operational efficiencies.
Cash, cash equivalents, and short-term investments were $959.9 million as of December 31, 2024.
Operational updates for the fourth quarter ended December 31, 2024:

As of December 31, 2024, there were 4,126 total active patients on TTFields therapy globally.
1,520 Optune Gio prescriptions for the treatment of GBM were received in the quarter, consistent with the same period in 2023. The U.S., Germany, France and Japan contributed 897; 190; 194 and 109 prescriptions, respectively, with the remaining 130 prescriptions contributed by other active markets.
As of December 31, 2024, there were 4,077 active Optune Gio patients on therapy. The U.S., Germany, France and Japan contributed 2,161; 564; 426 and 420 Optune Gio active patients, respectively, with the remaining 506 active patients contributed by other active markets.
On October 15, 2024, Optune Lua was approved by the U.S. FDA for the treatment of metastatic NSCLC concurrently with PD-1/PD-L1 inhibitors or docetaxel, in adults who have progressed on or after a platinum-based regimen. Between approval and year end, 52 Optune Lua prescriptions were received for metastatic NSCLC.
As of December 31, 2024, there were 20 active metastatic NSCLC patients on Optune Lua and 29 active malignant pleural mesothelioma (MPM) patients on Optune Lua.
Beginning in Q1 2026, Novocure intends to stop reporting new prescriptions received in period and will provide active patients on TTFields therapy by indication and by material market as the key operating statistics.
Fourth quarter and recent updates and achievements:

In October 2024, the FDA granted Breakthrough Device designation for the use of TTFields therapy for the treatment of brain metastases from NSCLC. Breakthrough Device designation provides more frequent, faster and interactive access to the FDA review team and senior management during the review process, priority review of marketing applications upon filing, and expedited review of pre-Premarket Approval Application (PMA) manufacturing and quality systems compliance inspections.
In October 2024, the FDA approved Novocure’s new HFE transducer arrays for use with Optune Gio for the treatment of adult patients with GBM.
In December 2024, the company announced the Phase 3 PANOVA-3 clinical trial met its primary endpoint, demonstrating a statistically significant improvement in overall survival for patients with unresectable, locally advanced pancreatic cancer. Novocure plans to submit the full data for presentation at an upcoming medical congress.
In December 2024, the FDA granted Breakthrough Device designation for the use of TTFields therapy for the treatment of unresectable, locally advanced pancreatic cancer.
In January 2025, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) approved Novocure’s HFE transducer arrays for use with Optune Gio for the treatment of adult patients with GBM.
Anticipated clinical milestones:

Data from Phase 2 PANOVA-4 clinical trial in metastatic pancreatic cancer (2026)
Data from Phase 3 TRIDENT clinical trial in newly diagnosed GBM (2026)
Fourth quarter and full year 2024 financial results conference call:

Novocure will host a conference call and webcast to discuss fourth quarter and full year 2024 financial results at 8:00 a.m. EST today, Thursday, February 27, 2025. To access the conference call by phone, use the following conference call registration link, and dial-in details will be provided. To access the webcast, use the following webcast registration link.

The webcast and earnings slides presented during the webcast and the corporate presentation can be accessed live from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for at least 14 days following the call. Novocure has used, and intends to continue to use, its investor relations website, as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.

On February 26, 2025 Adcendo, a biotech company pioneering the development of first and best-in-class ADCs for cancers with a high unmet medical need, reported that the U.S. Food & Drug Administration (FDA) has provided clearance of the IND application for a Phase I study evaluating ADCE-T02 in patients with advanced solid tumors (Press release, ADCendo, FEB 26, 2025, View Source [SID1234650619]).

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Tiffany-01 is an ongoing first-in-human Phase I multicenter, open-label, dose escalation study of ADCET02 as a monotherapy in patients with advanced solid tumors. The primary objectives of the study are to determine the maximum tolerated dose and recommended Phase II dose and schedule of ADCET02 monotherapy in addition to assessing ADCE-T02 safety and tolerability. The secondary objectives are to characterize the pharmacokinetics and to evaluate the preliminary efficacy of ADCE-T02. The study is currently recruiting in Australia and will start recruiting in the U.S. in the next few months.

"Tissue factor (TF) is a validated ADC target with overexpression in many high unmet need solid tumor indications, however, the currently approved TF targeting ADC has severe limitations due to a suboptimal side effect profile and a limited therapeutic window. The highly differentiated profile of ADCE-T02, based on the use of an improved monoclonal antibody and a next generation Topoisomerase I inhibitor linker/payload technology, could overcome those limitations and offer an enhanced therapeutic window and improved side effect profile, which may lead to better clinical outcomes for patients," said Dr. Lone Ottesen, Chief Medical Officer of Adcendo. "The U.S. IND clearance of ADCE-T02 is an important milestone for our program and our company, and we look forward to initiating patient enrollment in the U.S. and working closely with all of our investigators to evaluate the therapeutic utility of this drug in multiple advanced solid tumor indications."

Prof. Vinod Ganju. Managing Director of Peninsula and Southeast Oncology (PASO), Melbourne, Australia and Principal Investigator of Tiffany-01, commented: "ADCs have in the past years shown highly encouraging results and have already become Standard of Care in quite a number of solid tumor indications. ADCE-T02 represents an attractive new option to explore in advanced solid tumors with high unmet need. I am pleased to be working with Adcendo to develop ADCE-T02, potentially offering a broader therapeutic window and a better safety profile for our patients."

About ADCE-T02

Tissue Factor is a clinically validated ADC target with strong overexpression in multiple tumor indications with high unmet medical need including Cervical Cancer, Head and Neck Cancer, Colorectal Cancer, Non-Small Cell Lung Cancer, and Pancreatic Ductal Adenocarcinoma. ADCE-T02 is a highly differentiated anti-TF ADC, and the first ADC with a Topoisomerase I inhibitor-based linker/payload, clinically developed in Australia and the U.S. Its unique antibody design minimizes the impact on the coagulation pathway, while the T1000-exatecan linker-payload technology platform has been shown to amplify the bystander effect, improve linker stability, and has the potential to overcome emerging resistance mechanisms. These differentiated features are expected to translate into a superior therapeutic window, a better safety profile, enhanced response rates and longer duration of response.

On February 26, 2025 Microbiotica, a clinical-stage biopharma company developing a pipeline of oral precision microbiome medicines called live biotherapeutic products (LBPs), reported that it has presented new data on the mechanism of action of MB097 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) AACR (Free AACR Whitepaper) IO meeting held in Los Angeles, February 23-26 (Press release, Microbiotica, FEB 26, 2025, View Source [SID1234650634]). MB097 is an LBP in development as an adjunct to immune-oncology treatments such as MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA (pembrolizumab).

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Dr Mat Robinson, Microbiotica’s Senior Vice-President of Research, presented data from new pre-clinical studies in a poster entitled "Clinical response to immune checkpoint inhibitors in melanoma is associated with distinct gut bacterial species that promote anti-tumor immunity by different mechanisms". The poster can be accessed here (View Source)

The bacteria comprising MB097 were found to be associated with response to immune-oncology treatments, such as KEYTRUDA (pembrolizumab), in multiple cohorts of melanoma patients. These new data demonstrate that the bacterial strains within MB097 can interact directly with dendritic cells to potently activate cytotoxic T lymphocytes (CTL). In addition, certain MB097 bacteria also produced metabolites that enhanced the tumor cell-killing potential of CTLs. One strain released metabolites that reversed the inhibitory effects of tumor-associated macrophages.

Mat Robinson, Microbiotica’s Senior VP of Research, said, "These data begin to identify the different mechanisms by which gut commensal bacteria drive immunotherapy response."

MB097 is being tested in an international Phase Ib clinical study, in combination with KEYTRUDA (pembrolizumab), MSD’s anti-PD-1 therapy, in patients with cutaneous melanoma who have failed to respond to immunotherapies. Data readout expected by the end of 2025.

On February 26, 2025 Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, reported results generated in a joint research collaboration, combining Compugen’s AI/ML powered predictive computational discovery platform, Unigen, with high throughput single cell sequencing on Ultima’s UG 100 to uncover new insights on gene structure for immuno-oncology (Press release, Compugen, FEB 26, 2025, View Source [SID1234650650]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"We are excited to collaborate with Ultima Genomics, a pioneer in next generation gene sequencing, to enhance our proprietary gene sequencing database, which is part of our Unigen platform," said Eran Ophir, Ph.D., Chief Scientific Officer at Compugen. "We developed algorithms to study gene splicing in single cell resolution and applied it to analyze patient tumor samples to uncover new potential regulatory mechanisms in immuno-oncology. Some of the findings were presented at the AGBT conference. Compugen plans to further harness Ultima’s technology to develop its proprietary single cell atlases for accelerated discovery of new immunotherapies."

"We are excited to support Compugen’s capabilities in predictive computational discovery of new drug targets and development of new cancer immunotherapies," said Gilad Almogy, Founder and CEO of Ultima Genomics. "We built our innovative sequencing architecture and our UG 100 sequencing platform to enable researchers to unlock new applications and insights through lower cost sequencing and more omics data. The successful outcome of our collaboration with Compugen is a great example of an application that is data-starved due to the constraints of conventional sequencing technology and can be transformed through large scale data and AI/ML techniques. Single cell sequencing is also an excellent fit for our technology which is now compatible with the leading library prep technologies."

Dr. Roy Granit, Head of Computational Discovery at Compugen is the lead author on a poster presented by Ultima Genomics at the Advances in Genome Biology and Technology (AGBT) 2025 general meeting on February 25, 2025, in Marco Island, Florida.

Poster presentation details:

Title: Using 3′ Single Cell Sequencing to Study Patient-Derived Tumor Cells Reveals Enhanced Potential to Study Differential Splicing at the Cell Type Level
Poster number: 224
Date and time: Tuesday, February 25, 4:45 p.m. – 6:10 p.m. ET
Leading author: Roy Granit, Ph.D., Director, Head of Computational Discovery, Compugen, Israel
Presenter: Zohar Shipony, Ph.D. Ultima Genomics, United States

Key Findings:

Comparative analysis using tumor samples from cancer patients, found high consistency in single-cell expression levels across Ultima Genomics’ UG 100 and Illumina’s Novaseq 6000 sequencing platforms.
UG 100 offers clearer demarcation of 3′ mRNA transcript end and provides a unique opportunity to study gene structure, which can potentially be harnessed to better understand tumor biology and immune regulation.
Gene structure information identified in this approach is contributing to the predictive models of Unigen.
The poster is available on the publications section of Compugen’s website, www.cgen.com.

About Unigen

Compugen has been at the forefront of decoding cancer biology, with its AI/ML powered predictive computational discovery platform, recently branded as Unigen. Unigen is Compugen’s code-to-cure, flexible-loop platform for the computational prediction of novel drug target discovery and development of cancer immunotherapy. Unigen combines Compugen’s deep scientific knowledge, AI/ML predictive algorithms and a cloud-based, technology-agnostic platform integrating a variety of biological data such as multi-omics, single-cell RNA sequencing and spatial omics data. The outcomes from Compugen’s preclinical and clinical trials enrich the proprietary knowledgebase to discover additional novel drug targets and further understand complex biology. To date, Unigen has yielded multiple novel immuno-oncology drug targets, potential first- or best-in-class clinical stage immuno-oncology programs, validating partnerships with multiple pharmaceutical companies and undisclosed programs in its early-stage pipeline.

On February 26, 2025 Mabqi reported the company secures a €5 million non-dilutive financing from the France 2030 public investment plan to advance preclinical development of it’s lead antibody candidate MQI-201 in oncology (Press release, Mabqi, FEB 26, 2025, View Source [SID1234651774]).

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We are thrilled to announce a €5 million funding as part of the "Innovations in Biotherapies and Bioproduction" call for projects under the France 2030 public investment plan program, managed by BpiFrance.

This non-dilutive funding will accelerate the development of a patented first-in-class antibody for the treatment of metastatic prostate cancer, one of the most common cancers in the world.

Mabqi develops a first-in-class MQI-201 antibody specifically targeting the TRPV6 ion channel, an innovative therapeutic target in oncology. This funding will enable Mabqi to launch the bioproduction of this antibody, regulatory IND-enabling studies and FIH trial. We target a Phase I clinical study early 2027.

MQI-201 antibody candidate is the result of a close collaboration with SATT Nord and INSERM teams in Lille. It has already shown excellent tolerance and high efficacy in vivo prostate cancer models and could, in the long term, be used in combination with standard prostate cancer treatments.

Mabqi aims at discovering 2 antibodies candidates per year thanks to its proprietary human antibody library combined to an AI-powered phage & yeast display platform.