On May 8, 2025 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, reported first quarter 2025 financial results and corporate updates (Press release, Iovance Biotherapeutics, MAY 8, 2025, View Source [SID1234652748]).

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Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer of Iovance, stated, "During the start of the new year, our first quarter revenue was impacted by a significant reduction in capacity during the annual scheduled maintenance at the Iovance Cell Therapy Center (iCTC). Since full production has now resumed at the iCTC, we now expect infusions to grow in the second quarter as compared to the first quarter. Additionally, based on our experience to date, we are revising full-year 2025 revenue guidance to reflect recent launch dynamics. In the first 12 months of our U.S. launch, we have executed toward our long-term adoption goals by treating more than 275 Amtagvi patients and generating more than $210 million in revenue. Beyond the U.S. launch, we are on track this year for potential Amtagvi regulatory approvals in three new ex-U.S. markets as well as a clinical data update from our registrational trial in non-small cell lung cancer."

First Quarter 2025 Financial Results, Corporate Guidance, and Updates

Product Revenue and Guidance

First Quarter 2025 Total Product Revenue: Iovance recognized total revenue of $49.3 million from sales of Amtagvi and Proleukin during the first quarter ended March 31, 2025.

1Q25 Amtagvi Revenue: Product revenue from U.S. Amtagvi sales was $43.6 million, impacted by a reduction in capacity during annual scheduled maintenance at the iCTC. Production has resumed enabling full capacity for infusions in the second quarter 2025. Iovance currently anticipates infusing between 100 and 110 commercial patients in the second quarter.
1Q25 Proleukin Revenue: Product revenue also included $5.7 million in Proleukin sales, primarily reflecting clinical and manufacturing use after stocking at major U.S. wholesalers in 2024. Significant orders are expected in the current quarter. Proleukin is used in the Amtagvi treatment regimen and other commercial, clinical, manufacturing, and research settings, which provide additional revenue.
Amtagvi Growth Potential at U.S. ATCs in 2025: As of today, Iovance’s treatment network of more than 80 ATCs includes an initial wave of 70 ATCs and more than 10 ATCs in process to become a second wave. Fifty-six ATCs completed tumor resections, 48 infused one or more patients, and 11 infused more than 10 patients. These trends highlight growing adoption and significant growth potential. Several new ATCs are expected to treat their first patients in the remaining weeks of the second quarter of 2025.
Full Year 2025 Total Product Revenue Guidance: Iovance is revising total product revenue guidance within the range of $250 to $300 million in the first full calendar year of Amtagvi sales. The updated forecast considers experience with ATC growth trajectories and treatment timelines for new ATCs. Beyond ATCs, large community practices are expected to expand market opportunity. Amtagvi adoption will accelerate in 2025 with broader utilization and higher demand. Proleukin sales are also expected to accelerate throughout the remainder of 2025 with restocking to U.S. distributors and sales growth to manufacturers and for other clinical and manufacturing uses. Iovance expects significant growth in total product revenue for full year 2026 and beyond. Gross margins are expected to increase over time and remain on track to surpass 70% over the next several years.
Full Year 2025 Expense Guidance and Cash Position: As of March 31, 2025, Iovance had cash, cash equivalents, investments, and restricted cash of approximately $366 million. The current cash position and anticipated product revenue are expected to be sufficient to fund current and planned operations, including manufacturing expansion, into the second half of 2026. Cash burn for full year 2025 is expected to remain in line with prior guidance of less than $300 million, with a strong focus on optimizing spending and reducing expenses throughout the organization, including flat operating expenses related to Amtagvi manufacturing headcount expansion for the latter half of 2025.
Macroeconomic and Geopolitical Trends: Iovance is well-positioned to operate in the current macroeconomic and geopolitical environment. Amtagvi manufacturing and intellectual property are fully located in the U.S., providing a strategic advantage within the biopharma industry. All of Iovance’s investigational TIL products are manufactured in the U.S.
Amtagvi (Lifileucel) U.S. Launch Highlights in Advanced Melanoma

The U.S. FDA approved Amtagvi (lifileucel) on February 16, 2024, as the first treatment option for patients with advanced melanoma after anti-PD-1 and targeted therapy. Amtagvi is the first FDA-approved T cell therapy for a solid tumor indication.
More than 80 U.S. ATCs have joined or are about to join our network across 35 states and 95% of addressable patients live within 200 miles of an ATC. Additional U.S. ATCs will be added steadily throughout 2025, focusing on quality ATCs with a high volume of eligible patients, including large community practice ATCs.
Community referral activities are accelerating rapidly throughout the U.S. to drive additional patient volume to the ATCs. Large community practices are currently onboarding, creating a new and significant opportunity for more patients to receive Amtagvi quickly after frontline therapy.
Manufacturing turnaround time is aligning with launch expectations of approximately 34 days from inbound to return shipment to ATCs. Iovance expects to shorten the manufacturing turnaround time in 2025. The overall commercial manufacturing experience remains consistent with prior clinical experience.
Amtagvi is a preferred second-line or subsequent therapy in the National Comprehensive Cancer Network guidelines for treatment of cutaneous melanoma.
Reimbursement remains successful, with an average financial clearance time of about three weeks.
Approximately 75% of Amtagvi patients are covered by private payers. To date, payers or plans covering more than 250 million lives have added Amtagvi to policies since its launch.
Launch Expansion into New Markets

Amtagvi has the potential to address more than 30,000 patients annually with previously treated advanced melanoma across the U.S. and initial global markets with significant populations of previously treated advanced melanoma patients.¹
Regulatory dossiers are under review, submitted, or planned across multiple international markets for lifileucel for the treatment of adult patients with unresectable or metastatic melanoma after anti-PD-1 and targeted therapy. If approved, lifileucel will be the first and only approved therapy in this treatment setting in all markets.
Amtagvi has the potential to be approved in three new markets in 2025, including the United Kingdom, Canada, and all EU member states. Recently, the iCTC and Iovance’s contract manufacturer successfully completed regulatory inspections by the European Medicines Agency.
Fifteen ATCs are targeted by year-end to support initial launch markets outside the U.S.
Named patient programs are planned outside the U.S. to provide early access to treatment prior to national reimbursement and are also expected to provide initial revenue from these markets.
Additional regulatory submissions remain on track for Australia in the first half of 2025 and Switzerland in the second half of 2025.
Recent Iovance TIL Cell Therapy Pipeline Highlights

Lifileucel in Frontline Advanced Melanoma
Strong momentum continues with global site activation and patient enrollment in the registrational TILVANCE-301 trial, which is intended to support U.S. approval of Amtagvi in combination with pembrolizumab in frontline advanced melanoma, and full approval in post-anti-PD-1 melanoma.
Cohort 1D in the IOV-COM-202 trial is investigating lifileucel in combination with nivolumab and relatlimab in frontline advanced melanoma.
Lifileucel in Previously Treated Advanced Non-Small Cell Lung Cancer (NSCLC)
Iovance remains on track to share additional data in the second half of 2025 from the IOV-LUN-202 registrational Phase 2 trial in post-anti-PD-1 NSCLC.
The IOV-LUN-202 trial is intended to support a potential accelerated approval of lifileucel in post-anti-PD-1 NSCLC in the U.S., with an anticipated regulatory decision in 2027. The FDA previously provided positive regulatory feedback on the proposed potency matrix in NSCLC and the IOV-LUN-202 clinical trial design.
Lifileucel in Frontline Advanced NSCLC
Iovance is pursuing a frontline therapy strategy to integrate lifileucel plus pembrolizumab following chemotherapy for patients with EGFR wild type NSCLC, representing most patients with an unmet medical need in this setting.
Cohorts 3D and 3E in IOV-COM-202 trial are investigating this regimen to inform a registrational and confirmatory trial design in frontline advanced NSCLC.
Lifileucel in Endometrial Cancer
Iovance is actively enrolling in the IOV-END-201 Phase 2 trial for advanced endometrial cancer, with initial results expected in the second half of 2025. The trial is investigating lifileucel after platinum-based chemotherapy and anti-PD-1 therapy regardless of mismatch repair (MMR) status, which represents a significant unmet medical need.
Next Generation TIL Pipeline
PD-1 Inactivated TIL Cell Therapy (IOV-4001): The Phase 2 efficacy portion of the IOV-GM1-201 trial continues to enroll patients to evaluate IOV-4001 in previously treated advanced melanoma and NSCLC. Iovance utilizes the TALEN technology licensed from Cellectis to develop IOV-4001 and other investigational gene-edited TIL cell therapies with multiple knockout targets to potentially improve efficacy.
Next Generation Interleukin-2 (IL-2) for TIL Treatment Regimen (IOV-3001): A Phase 1/2 clinical trial, IOV-IL2-101, is enrolling patients to investigate IOV-3001, a second-generation, modified IL-2 analog for use in the TIL therapy treatment regimen. Preclinical studies of IOV-3001 demonstrated the potential for improved safety with strong effector T cell expansion.
Next Generation, Cytokine-Tethered TIL Therapy (IOV-5001): IND-enabling studies are proceeding as planned for IOV-5001, a genetically engineered, inducible, and tethered interleukin-12 (IL-12) TIL cell therapy, in support of an IND in 2025 for clinical development for multiple indications.
Manufacturing Capacity Expansion

Iovance’s U.S.-based manufacturing network, consisting of the iCTC and an FDA-approved contract manufacturer, supplies clinical and commercial TIL cell therapies to patients globally.
The iCTC facility, representing the bulk of Amtagvi and clinical TIL product production, completed annual scheduled maintenance and successfully restarted full production.
The Iovance manufacturing network currently has staffed capacity for more than 1,300 patients annually and is built to serve several thousand patients annually with commercial Amtagvi and for clinical trials across North America, Europe and Asia Pacific. Expansion is currently underway at the iCTC facility to supply TIL cell therapies to more than 5,000 patients annually in the next few years, with additional expansion opportunities also in development.
Corporate Updates

Iovance currently owns approximately 280 granted or allowed U.S. and international patents and patent rights for Amtagvi and other TIL-related technologies that are expected to provide exclusivity through at least 2042. This patent portfolio covers TIL compositions and methods of treatment and manufacturing in a broad range of cancers, with Gen 2 patent rights expected to provide exclusivity for Amtagvi into 2038 and additional patent rights, including methods of treating melanoma and compositions and methods for potency assays, expected to provide exclusivity into 2039 and 2042, respectively. Iovance also owns an industry-leading patent portfolio covering TIL products produced with genetic engineering, using core biopsies and peripheral blood as starting material, and using combinations of TIL products with checkpoint inhibitors, as well as Iovance’s proprietary IovanceCares system. More information on Iovance’s patent portfolio is available on the Intellectual Property page on www.iovance.com.
First Quarter 2025 Financial Results

As of March 31, 2025, Iovance’s cash position is approximately $366 million. The current cash position and anticipated product revenue are expected to be sufficient to fund current and planned operations into the second half of 2026.

Net loss for the first quarter of 2025 was $116.2 million, or $0.36 per share, compared to a net loss of $113.0 million, or $0.42 per share, for the first quarter of 2024.

Revenue was $49.3 million for the first quarter of 2025 and consisted of product revenue from Amtagvi and Proleukin sales. Iovance recognized $43.6 million in revenue from Amtagvi infusions that were completed during the first quarter of 2025 and $5.7 million in global revenue for Proleukin. Revenue for the first quarter of 2024 was $0.7 million for global sales of Proleukin.

The increase in revenue in the first quarter 2025 over the prior year period was primarily attributable to the U.S. launch of Amtagvi, including revenue recognized for Amtagvi, as well as Proleukin revenue in the U.S.

Cost of sales includes inventory, overhead and related cash and non-cash expenses that are directly associated with sales of Amtagvi and Proleukin, as well as manufacturing costs for Amtagvi. Cost of sales for the first quarter 2025 was $49.7 million, which included $15.0 million for period costs associated with patient drop off and manufacturing success rates, $5.4 million for non-cash amortization expense for intangible assets and fair value mark up of inventory, and $1.3 million in royalties payable on product sales. For the first quarter 2024, cost of sales of $7.3 million was primarily related to non-cash amortization for intangible assets.

Increases in cost of sales in the first quarter over the prior year period were primarily attributable to costs associated with the initiation and growth of product sales, certain costs associated with patient drop off and manufacturing success rates, and related cash and non-cash expenses tied to the U.S. launch of Amtagvi that began during the first quarter of 2024.

Research and development expenses were $76.9 million for the first quarter of 2025, a decrease of 4% compared to $79.8 million for the first quarter of 2024. The decreases in research and development expenses in the first quarter 2025 over the prior year period were primarily attributable to the transition of Amtagvi to commercial manufacturing. This decrease was partially offset by higher headcount and related costs, including stock-based compensation, and clinical trial costs resulting from continued enrollment in existing trials.

Selling, general and administrative expenses were $43.9 million for the first quarter of 2025, an increase of 40% compared to $31.4 million for the first quarter of 2024. The increase in selling, general and administrative expenses in the first quarter compared to the prior year period was primarily attributable to increases in headcount and related costs, including stock-based compensation, to support the growth in the overall business and related corporate infrastructure, as well as marketing and legal costs and costs incurred to support the commercialization of Amtagvi and Proleukin.

For additional information, please see the Company’s Selected Consolidated Balance Sheets and Statements of Operations below.

Webcast and Conference Call

Management will host a conference call and live audio webcast to discuss these results and provide a corporate update today at 4:30 p.m. ET. To listen to the live or archived audio webcast, please register at View Source The live and archived webcast can be accessed in the Investors section of the Company’s website, IR.Iovance.com, for one year.

1. World Health Organization International Agency for Research on Cancer (IARC) GLOBOCAN 2022.

On May 8, 2025 Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage gene editing company focused on revolutionizing medicine with CRISPR-based therapies, reported operational highlights and financial results for the first quarter ended March 31, 2025 (Press release, Intellia, MAY 8, 2025, View Source [SID1234652747]).

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"Intellia is full steam ahead and making excellent progress across its clinical programs," said Intellia President and Chief Executive Officer John Leonard, M.D. "Two key achievements in the first quarter were dosing the first patients in two of our Phase 3 studies: the HAELO study for hereditary angioedema and the MAGNITUDE-2 study for hereditary ATTR amyloidosis with polyneuropathy. Additionally, our Phase 3 MAGNITUDE study for ATTR with cardiomyopathy continues to enroll rapidly. Upcoming catalysts include longer-term data from the ongoing Phase 1 study of NTLA-2002 at the upcoming EAACI Congress in addition to updated data from the Phase 2 study of NTLA-2002 and longer-term Phase 1 data of nex-z in the second half of 2025."

First Quarter 2025 and Recent Operational Highlights

Hereditary Angioedema (HAE)

NTLA-2002: NTLA-2002 is a wholly owned, investigational in vivo CRISPR-based therapy designed to knock out the KLKB1 gene in the liver, with the goal of lifelong control of HAE attacks after a single dose.
Intellia will present additional data from the ongoing Phase 1/2 study in an oral presentation at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2025 on Sunday, June 15 in Glasgow, United Kingdom. The presentation will include longer-term durability data from patients in the Phase 1 portion of the Phase 1/2 study.
Enrollment is progressing in the global Phase 3 HAELO study and the Company expects to complete enrollment in the third quarter of 2025.
Intellia expects to present new and longer-term data from the Phase 2 portion of the ongoing Phase 1/2 study in the second half of 2025. The data will include patients who initially received a 25 mg dose or placebo and were subsequently given the 50 mg dose of NTLA-2002 selected for the Phase 3 study.
The Company is on track to submit a Biologics License Application (BLA) in the second half of 2026.
Transthyretin (ATTR) Amyloidosis

Nexiguran ziclumeran (nex-z, also known as NTLA-2001): Nex-z is an investigational in vivo CRISPR-based therapy designed to inactivate the TTR gene in liver cells, thereby preventing the production of transthyretin (TTR) protein for the treatment of ATTR amyloidosis. Nex-z offers the possibility of halting and reversing the disease by driving a deep, consistent and potentially lifelong reduction in TTR protein after a single dose. Nex-z has been generally well tolerated across all patients and at all dose levels tested. The most common treatment-related adverse events have been mild or moderate infusion reactions; all patients were able to receive the intended dose of nex-z. Intellia leads development and commercialization of nex-z in collaboration with Regeneron Pharmaceuticals, Inc.
ATTR Amyloidosis with Cardiomyopathy (ATTR-CM):
In March, Intellia announced the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) to nex-z for the treatment of ATTR-CM.
Enrollment in the global Phase 3 MAGNITUDE trial is progressing ahead of the Company’s target projections and anticipates enrollment to exceed 550 total patients by year-end.
Hereditary ATTR Amyloidosis with Polyneuropathy (ATTRv-PN):
In April, the Company announced the first patient was randomized and dosed with nex-z in the global Phase 3 MAGNITUDE-2 study. Intellia expects enrollment to be completed in 2026.
In May, the Company will present data at the European Society of Cardiology Heart Failure (ESC-HF) Congress and Peripheral Nerve Society (PNS) Annual Meeting. At ESC-HF, Intellia will show wildtype vs. variant data in patients with ATTR-CM. At PNS, the Company will present interim Phase 1 extended data in patients with ATTRv-PN.
Intellia expects to present longer-term data from both ATTR-CM and ATTRv-PN patients in the Phase 1 study in the second half of 2025. The data will include updated measures of clinical efficacy and safety.
Platform Update

Intellia is pioneering novel technologies, such as CRISPR-based gene editing technologies and lipid nanoparticle (LNP) delivery technologies, to create highly differentiated, future in vivo and ex vivo product candidates. The Company’s proprietary platform technologies are being researched and developed to expand therapeutics opportunities to support the mission of transforming lives of people with severe diseases, including the possibility of curative genome editing therapeutics.
Upcoming Events

The Company will participate in the following events during the second quarter of 2025:

Bank of America Securities Health Care Conference, May 13, Las Vegas
ESC Heart Failure Congress, May 17, Belgrade
PNS Annual Meeting, May 18, Edinburgh
RBC Capital Markets Global Healthcare Conference, May 21, New York
EAACI Congress, June 15, Glasgow
First Quarter 2025 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $707.1 million as of March 31, 2025, compared to $861.7 million as of December 31, 2024. The decrease in cash, cash equivalents and marketable securities was primarily driven by first quarter operations and approximately $51 million of non-recurring cash payments associated with the Company’s previously announced portfolio prioritization, workforce reduction, and real estate consolidation. The Company’s cash, cash equivalents and marketable securities as of March 31, 2025 are expected to fund operations into the first half of 2027.
Collaboration Revenue: Collaboration revenue was $16.6 million during the first quarter of 2025, compared to $28.9 million during the first quarter of 2024. The $12.3 million decrease was mainly driven by a decrease in collaboration revenue under the AvenCell license and collaboration agreement.
R&D Expenses: Research and development (R&D) expenses were $108.4 million during the first quarter of 2025, compared to $111.8 million during the first quarter of 2024. The $3.4 million decrease was primarily driven by employee-related expenses, stock-based compensation, research materials and contracted services offset by an increase in the advancement of our lead programs. Stock-based compensation expense included in R&D expenses was $12.6 million for the first quarter of 2025.
G&A Expenses: General and administrative (G&A) expenses were $29.0 million during the first quarter of 2025, compared to $31.1 million during the first quarter of 2024. The $2.1 million decrease was primarily related to lower employee-related expenses due to a workforce reduction in January 2025 and lower stock-based compensation, partially offset by increases related to severance expenses recorded in the first quarter. Stock-based compensation expense included in G&A expenses was $9.2 million for the first quarter of 2025.
Net Loss: Net loss was $114.3 million for the first quarter of 2025, compared to $107.4 million during the first quarter of 2024.
Conference Call to Discuss First Quarter 2025 Results

The Company will discuss these results on a conference call today, Thursday, May 8 at 8 a.m. ET.
To join the call:

U.S. callers should dial 1-833-316-0545 and international callers should dial 1-412-317-5726, approximately five minutes before the call. All participants should ask to be connected to the Intellia Therapeutics conference call.
Please visit this link for a simultaneous live webcast of the call.
A replay of the call will be available through the Events and Presentations page of the Investors & Media section on Intellia’s website at intelliatx.com, beginning on May 8 at 12 p.m. ET.

On May 8, 2025 IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, reported that the first trial site has been initiated for the Company’s Phase 3 pivotal study, called OVATION 3, of its lead candidate IMNN-001 in development for the treatment of women with newly diagnosed advanced ovarian cancer (Press release, IMUNON, MAY 8, 2025, View Source [SID1234652746]). The first trial site is Washington University School of Medicine, and IMUNON is currently initiating additional trial sites and working with investigators to begin enrolling study participants.

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"This represents a significant step forward for the IMNN-001 development program as we work toward bringing patients this novel IL-12 immunotherapy, the first and only product to show meaningful overall survival benefit in women newly diagnosed with advanced ovarian cancer who have not seen changes in standard of care treatment in more than 25 years," said Premal H. Thaker, M.D., Interim Chief of Gynecologic Oncology, David & Lynn Mutch Distinguished Professor of Obstetrics & Gynecology, Director of Gynecologic Oncology Clinical Research at Washington University School of Medicine, and study-level principal investigator of the OVATION 3 trial. "It has been rewarding to be part of IMNN-001’s development for more than a decade and see the progress being made, with highly encouraging data from the Phase 2 study including in women treated with PARP inhibitors as maintenance therapy. I look forward to helping advance the OVATION 3 trial and seeing the results."

The Phase 3 OVATION 3 trial will assess the safety and efficacy of IMNN-001 (100 mg/m2 administered intraperitoneally weekly) plus neoadjuvant and adjuvant chemotherapy (N/ACT) of paclitaxel and carboplatin compared to standard of care (SoC) N/ACT alone. Study participants will be randomized 1:1 and include women with newly diagnosed advanced ovarian cancer (stage 3C or 4) who are eligible for neoadjuvant therapy, the intent-to-treat (ITT) population, with a sub-group of women positive for homologous recombination deficiency (HRD), including BRCA1 or BRCA2 mutations. Participants who are HRD positive will receive poly ADP-ribose polymerase (PARP) inhibitors as part of standard maintenance therapy. The primary endpoint of the study is overall survival (OS), and secondary endpoints are surgical response score, chemotherapy response score, clinical response and time to second-line treatment. The study will also assess several exploratory endpoints.

In December 2024, the Company reported additional clinical data from ongoing analyses of results from the Phase 2 OVATION 2 Study of IMNN-001. IMUNON will highlight new IMNN-001 data from OVATION 2 in an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held May 30 – June 3, 2025, in Chicago, Illinois.

"Initiating the first site for our Phase 3 pivotal trial is an important milestone in our efforts to make IMNN-001 available to women who receive the devastating diagnosis of advanced ovarian cancer and are in urgent need of additional treatment options," said Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON. "We are grateful for the continued dedication and support of our team, the investigators and, most importantly, the participants in our clinical trials and their families to help get us to where we are today. Together, we look forward to this next stage of development for IMNN-001, with the latest results bringing new hope that this therapy may make a meaningful difference in people’s lives."

About the Phase 2 OVATION 2 Study

OVATION 2 evaluated the dosing, safety, efficacy and biological activity of intraperitoneal administration of IMNN-001 in combination with neoadjuvant and adjuvant chemotherapy (N/ACT) of paclitaxel and carboplatin in patients newly diagnosed with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer. Treatment in the neoadjuvant period is designed to shrink the tumors as much as possible for optimal surgical removal after three cycles of chemotherapy. Following N/ACT, patients undergo interval debulking surgery, followed by three additional cycles of adjuvant chemotherapy to treat any residual tumor. This open-label study enrolled 112 patients who were randomized 1:1 and evaluated for safety and efficacy to compare N/ACT plus IMNN-001 versus standard-of-care N/ACT. In accordance with the study protocol, patients randomized to the IMNN-001 treatment arm could receive up to 17 weekly doses of 100 mg/m2 in addition to N/ACT. As a Phase 2 study, OVATION 2 was not powered for statistical significance. Additional endpoints included objective response rate, chemotherapy response score and surgical response.

About IMNN-001 Immunotherapy

Designed using IMUNON’s proprietary TheraPlas platform technology, IMNN-001 is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system that enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anticancer immunity acting through the induction of T-lymphocyte and natural killer cell proliferation. IMUNON previously reported positive safety and encouraging Phase 1 results with IMNN-001 administered as monotherapy or as combination therapy in patients with advanced peritoneally metastasized primary or recurrent ovarian cancer and completed a Phase 1b dose-escalation trial (the OVATION 1 Study) of IMNN-001 in combination with carboplatin and paclitaxel in patients with newly diagnosed ovarian cancer. IMUNON previously reported positive results from the recently completed Phase 2 OVATION 2 Study, which assessed IMNN-001 (100 mg/m2 administered intraperitoneally weekly) plus neoadjuvant and adjuvant chemotherapy (N/ACT) of paclitaxel and carboplatin compared to standard-of-care N/ACT alone in 112 patients with newly diagnosed advanced ovarian cancer.

About Epithelial Ovarian Cancer

Epithelial ovarian cancer is the sixth deadliest malignancy among women in the U.S. There are approximately 20,000 new cases of ovarian cancer every year and approximately 70% are diagnosed in advanced Stage III/IV. Epithelial ovarian cancer is characterized by dissemination of tumors in the peritoneal cavity with a high risk of recurrence (75%, Stage III/IV) after surgery and chemotherapy. Since the five-year survival rates of patients with Stage III/IV disease at diagnosis are poor (41% and 20%, respectively), there remains a need for a therapy that not only reduces the recurrence rate, but also improves overall survival. The peritoneal cavity of advanced ovarian cancer patients contains the primary tumor environment and is an attractive target for a regional approach to immune modulation.

On May 8, 2025 Illumina, Inc. (Nasdaq: ILMN) ("Illumina" or the "company") reported its financial results for the first quarter of fiscal year 2025 (Press release, Illumina, MAY 8, 2025, View Source [SID1234652745]).

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"I’m proud that the Illumina team delivered strong Q1 revenue and EPS, a good start to the year in an increasingly dynamic business environment," said Jacob Thaysen, Chief Executive Officer. "Our outlook for the year has weakened due to shifting policy and geopolitical developments and we have taken swift incremental actions to protect our earnings. Our strategic focus remains on customer collaboration, driving differentiated innovations, and delivering on our long-term financial targets of growth and profitability."

First quarter Core Illumina segment results

GAAP Non-GAAP (a)
Dollars in millions, except per share amounts
Q1 2025 Q1 2024 Q1 2025 Q1 2024
Revenue (b) $ 1,041 $ 1,056 $ 1,041 $ 1,056
Gross margin (c) 65.6 % 65.7 % 67.4 % 67.1 %
Research and development (R&D) expense $ 252 $ 241 $ 241 $ 237
Selling, general and administrative (SG&A) expense $ 267 $ 336 $ 248 $ 254
Operating profit
$ 164 $ 116 $ 212 $ 218
Operating margin 15.8 % 11.0 % 20.4 % 20.6 %
Tax provision $ 51 $ 45 $ 44 $ 54
Tax rate 27.9 % 39.3 % 22.0 % 25.7 %
Net income $ 131 $ 70 $ 154 $ 155
Diluted EPS $ 0.82 $ 0.44 $ 0.97 $ 0.98

(a)See tables in "Results of Operations – Non-GAAP" section below for GAAP and non-GAAP reconciliations.
(b)Revenue for Q1 2024 included intercompany revenue of $7 million prior to the spin-off of GRAIL.
(c)Increase in gross margin was driven by execution of our operational excellence initiatives, that continue to deliver cost savings and improve productivity, and lower strategic partnership revenue that is lower margin, offset by lower product margins, primarily due to reduced pricing, and an increase in field service costs.

Capital expenditures for free cash flow purposes were $32 million for Q1 2025. Cash flow provided by operations was $240 million, compared to $284 million in the prior year period. Free cash flow (cash flow provided by operations less capital expenditures) was $208 million for the quarter, compared to $251 million in the prior year period. Depreciation and amortization expense was $69 million for Q1 2025. At the close of the quarter, the company held $1.24 billion in cash, cash equivalents and short-term investments.

Share repurchases for Q1 2025 were $200 million and the company intends to repurchase incremental shares over the course of the year as part of our ~$1.2 billion authorization remaining at the end of the quarter.

Key announcements since our last earnings release
•Instituted an incremental $100 million cost reduction program to mitigate the impact of a range of potential scenarios for a reduction in revenue and related operating income from the company’s Greater China business
•Unveiled first-of-its-kind spatial transcriptomics technology; Broad Institute to collaborate on flagship project
•Announced collaboration with Broad Clinical Labs to rapidly streamline and scale single-cell projects with cutting-edge tools and workflows
•Unveiled a series of roadmap innovations spanning genomics, spatial transcriptomics, single cell analysis, CRISPR technologies, epigenetics, and data analytics software
•Sequenced 250,000 whole genomes for the Alliance for Genomic Discovery (AGD) initiative
•Announced partnership with Tempus to accelerate clinical adoption of next-generation sequencing tests through novel evidence generation
•Dr. Scott Gottlieb elected as Board Chair, Keith Meister joined Board of Directors
•Named for the sixth year in a row to the Dow Jones Best-in-Class World Index and the Dow Jones Best-in-Class North America Index

A full list of recent announcements can be found in the company’s News Center.

Financial outlook and guidance
For fiscal year 2025, we expect:
◦Core Illumina revenue to decline between (1%) and (3%) on a constant currency basis year over year, down from low single digit growth previously
▪Revenue outside of the Greater China region expected to grow between 0% and 2% in 2025 on a constant currency basis year over year and includes our estimate reflecting changes in the research funding environment as well as the projected benefit from pricing actions
▪Reported revenue from the Greater China region expected to be $165 – $185 million in 2025 (with $72 million in revenue recognized in Q1 2025)
◦$85 million in tariff related costs which after actions is an approximate 125 bps reduction in fiscal year 2025 operating margin and $0.25 of EPS
◦Non-GAAP operating margin of approximately 21.5% – 22.0%, down from approximately 23% previously; and non-GAAP diluted EPS in the range of $4.20 – $4.30, a reduction from our March guidance of approximately $4.50, primarily due to the net impact of tariffs

The company provides forward-looking guidance on a non-GAAP basis, including on a constant currency basis for revenue and revenue growth rates. The company is unable to provide a reconciliation of forward-looking non-GAAP financial measures to the most directly comparable GAAP reported financial measures because it is unable to predict with reasonable certainty the impact of items such as acquisition-related expenses, fair value adjustments to contingent consideration, gains and losses from strategic investments, potential future asset impairments, restructuring activities, the ultimate outcome of pending litigation, and currency exchange rate fluctuations without unreasonable effort. These items are uncertain, inherently difficult to predict, depend on various factors, and could have a material impact on GAAP reported results for the guidance period. For the same reasons, the company is unable to address the significance of the unavailable information, which could be material to future results.

On May 8, 2025 Genmab reported interim results for the first Quarter ended March 31, 2025 (Press release, Genmab, MAY 8, 2025, View Source [SID1234652743]).

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Highlights

EPKINLY (epcoritamab) approved by the Japan Ministry of Health, Labour and Welfare (MHLW) for additional indication as a treatment for relapsed or refractory follicular lymphoma (FL)
Rinatabart sesutecan (Rina-S) continues to show encouraging antitumor activity in patients with advanced ovarian cancer in data presented at the 2025 Society of Gynecologic Oncology Annual Meeting on Women’s Cancer (SGO)
Tivdak (tisotumab vedotin) approved by the Japan MHLW and by the European Commission (EC) as the first and only antibody-drug conjugate (ADC) approved in both Japan and the European Union (EU) for the treatment of recurrent or metastatic cervical cancer after prior therapy
Genmab revenue increased 19% compared to the first quarter of 2024, to $715 million
"Our commitment to advancing our late-stage programs was reflected in the progress we made in the first quarter of the year. Both EPKINLY and Tivdak expanded their reach with approvals in additional territories and the updated Rina-S data presented at SGO reinforces its potential as a treatment option for patients with advanced ovarian cancer," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Financial Performance First Quarter of 2025

Revenue was $715 million for the first three months of 2025 compared to $603 million for the first three months of 2024. The increase of $112 million, or 19%, was primarily driven by higher DARZALEX and Kesimpta royalties achieved under our collaborations with Johnson & Johnson (J&J) and Novartis Pharma AG (Novartis), respectively, and EPKINLY net product sales.
Royalty revenue was $589 million in the first three months of 2025 compared to $452 million in the first three months of 2024, an increase of $137 million, or 30%. The increase in royalties was driven by higher net sales of DARZALEX and Kesimpta.
Net sales of DARZALEX (daratumumab), including sales of the subcutaneous (SC) product (daratumumab and hyaluronidase-fihj, sold under the tradename DARZALEX FASPRO in the U.S.) by J&J were $3,237 million in the first three months of 2025 compared to $2,692 million in the first three months of 2024, an increase of $545 million or 20%.
Total costs and operating expenses were $527 million in the first three months of 2025 compared to $487 million in the first three months of 2024. The increase of $40 million, or 8%, was driven by the expansion of our product pipeline, including Rina-S, the continued development of Genmab’s broader organizational capabilities as well as profit-sharing amounts payable to AbbVie Inc. (AbbVie) related to EPKINLY sales.
Operating profit was $188 million in the first three months of 2025 compared to $116 million in the first three months of 2024.
Net financial items resulted in income of $56 million for the first three months of 2025 compared to $133 million in the first three months of 2024. The decrease was primarily due to a decrease in foreign exchange impacts driven by the change in functional currency of Genmab A/S on January 1, 2025.

Outlook
Genmab is maintaining its 2025 financial guidance published on February 12, 2025.

Other Matters
Both the functional currency of the Genmab A/S legal entity and the presentation currency of the condensed consolidated financials statements have been changed from DKK to USD effective January 1, 2025. The change in functional currency has been implemented with prospective effect. The change in presentation currency has been implemented with retrospective effect. Comparative figures for prior periods have been restated accordingly.

Conference Call
Genmab will hold a conference call to discuss the results for the first quarter of 2025 today, Thursday, May 8, at 6:00 pm CEST, 5:00 pm BST or 12:00 pm EDT. To join the call please use the below registration link. Registered participants will receive an email with a link to access dial-in information as well as a unique personal PIN: https://register.vevent.com/register/BI2b36f53f97c64ad190f5eaa552875059. A live and archived webcast of the call and relevant slides will be available at View Source