On May 8, 2025 Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), an oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), reported its financial results for the first quarter of 2025 and recent business highlights (Press release, Sutro Biopharma, MAY 8, 2025, View Source [SID1234652763]).

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"In the first quarter, we announced a strategic decision to shift Sutro’s product candidate focus from luvelta to our pipeline of wholly-owned novel exatecan and dual-payload ADCs. As part of this review, we selected STRO-004—a next-generation Tissue Factor-targeting exatecan/Topo 1 ADC—as our lead clinical candidate, supported by strong preclinical data that point to its best-in-class potential," said Jane Chung, Sutro’s Chief Executive Officer. "At AACR (Free AACR Whitepaper), we presented on STRO-004’s potent, dose-dependent anti-tumor activity and favorable safety profile across multiple dose levels and highlighted the unique capabilities of our XpressCF+ cell-free platform to develop novel dual-payload ADCs—an approach that holds significant promise for some of the most difficult-to-treat cancers. Additionally, next week, we have the opportunity to present preclinical data on STRO-006 for the first time, demonstrating encouraging pharmacokinetics (PK) and anti-tumor activity."

Ms. Chung continued: "We currently are on track to deliver three new INDs over the next three years, starting with STRO-004, which is expected to enter clinical studies in the second half of this year. Our rich pipeline, made possible by our optimized cell-free platform, is designed to engage complex, hard-to-drug targets with next-generation single- and dual-payloads. We are also already seeing the extraordinary capabilities of our platform yield important advances in our collaboration with Astellas, with the recent initiation of an IND-enabling toxicology study for the first dual-payload immunostimulatory ADC program under our collaboration, triggering a milestone payment to Sutro. Our team remains inspired by the immense potential of our platform and pipeline, and the substantial benefit it can bring to patients and to our partners."

Corporate and Program Updates

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In March, Sutro announced completion of a strategic portfolio review resulting in the prioritization of its wholly-owned next-generation ADC programs. While Sutro will not continue the development of luveltamab tazevibulin (luvelta) on its own, it remains open to partnership opportunities.

Wholly-Owned Pipeline

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STRO-004: Sutro’s novel exatecan Tissue Factor ADC has been prioritized as the Company’s lead program, with an initial focus on solid tumors. The Company is preparing to submit an IND and initiate a first-in-human study in the second half of 2025.
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STRO-006: Sutro’s differentiated integrin beta-6 (ITGB6) ADC is expected to enter clinical development in 2026, aimed at multiple solid tumors.
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Dual-Payload Program: An IND for Sutro’s first wholly-owned dual-payload ADC is anticipated to be filed in 2027.

Existing Collaborations for Next-Generation ADCs

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Ipsen: A drug development program is ongoing with Ipsen for STRO-003, a ROR1 ADC.
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Astellas: Two research and development programs are ongoing with Astellas for dual-payload immunostimulatory ADCs (iADCs), one of which has initiated an IND-enabling toxicology study triggering a milestone payment to Sutro.

These collaborations remain a strategic priority given their long-term value creation potential and the increasing relevance of specialized ADCs in the treatment of cancer.

Medical Conferences

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21st Annual PEGS Boston: The Essential Proteins Engineering & Cell Therapy Summit: In May, Sutro will present promising preclinical data with STRO-006, highlighting its superior anti-tumor activity compared to first generation ITGB6 ADCs at clinically relevant dose levels, as well as its favorable PK and tolerability profile.
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2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting: In April, Sutro presented encouraging preclinical results with STRO-004 and its dual-payload ADC programs. Among the highlights, a single dose of STRO-004 led to promising overall response and disease control rates in Tissue Factor-positive patient-derived xenograft models spanning multiple cancer types. Additionally, STRO-004 has a favorable safety profile in cynomolgus monkeys up to 50 mg/kg, the highest dose tested.
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Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer: In March, expanded data were presented in a late-breaking oral presentation from the dose-optimization portion of the REFRαME-O1 trial with luvelta in patients with platinum resistant ovarian cancer. In the study, luvelta demonstrated encouraging antitumor activity in patients with late-stage ovarian cancer across all levels of Folate Receptor-α expression of 25% or greater, including an improved overall response rate, a low discontinuation rate, and a consistent safety profile across dose levels.

Upcoming Investor Conferences

Management will participate in the following upcoming healthcare investor conferences. Webcasts of the presentations will be accessible through the News & Events page of the Investor Relations section of the Company’s website at www.sutrobio.com. Archived replays will be available for at least 30 days after the event.

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TD Cowen’s 6th Annual Oncology Innovation Summit, May 27-28, 2025, Virtual
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Jefferies 2025 Global Healthcare Conference, June 3-5, 2025, in New York

Organization

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As part of the restructuring, Jane Chung, President and Chief Operating Officer, assumed the responsibilities as Chief Executive Officer and was appointed as a member of the Sutro Board. The Company is also reducing its organizational headcount by nearly 50 percent and decommissioning its manufacturing facility by year-end 2025. Manufacturing capabilities to support the next-generation ADC pipeline have been fully established and scaled up externally.

First Quarter 2025 Financial Highlights

Cash, Cash Equivalents and Marketable Securities

As of March 31, 2025, Sutro had cash, cash equivalents and marketable securities of $249.0 million, as compared to $316.9 million as of December 31, 2024. Cost reductions subsequently realized from the restructuring, combined with refocused clinical development priorities give the Company an expected cash runway into early 2027, excluding additional anticipated milestones from existing collaborations.

Revenue

Revenue was $17.4 million for the quarter ended March 31, 2025, as compared to $13.0 million for the quarter ended March 31, 2024, with the 2025 amount related principally to the Astellas collaboration. Future collaboration and license revenue under existing agreements, and from any additional collaboration and license partners, will fluctuate as a result of the amount and timing of revenue recognition of upfront, milestones, and other agreement payments.

Research & Development (R&D) and General & Administrative (G&A) Expenses

Total R&D and G&A expenses for the quarter ended March 31, 2025 were $64.9 million, as compared to $69.6 million for the quarter ended March 31, 2024. The 2025 period includes non-cash expenses for stock-based compensation of $5.5 million and depreciation and amortization of $1.9 million, as compared to $6.1 million and $1.8 million, respectively, in the 2024 period. For the quarter ended March 31, 2025, R&D expenses were $51.6 million and G&A expenses were $13.3 million.

Restructuring and Related Costs

Restructuring and related costs for the quarter ended March 31, 2025 were $21.0 million. Sutro will continue to recognize restructuring and related costs in future periods for the deprioritization of the luvelta program, of which it expects to recognize a significant portion in 2025. The ultimate amount of expense will be affected by the timing to complete Sutro’s cost commitments to its third-party CROs and CMOs and the full wind-down of the clinical trials. Sutro will revise its estimates of the costs to deprioritize these studies for the luvelta program and the amount of severance and benefits paid to employees as new information becomes available to the Company in future periods.

On May 8, 2025 Cellipont Bioservices, a leading cell therapy Contract Development and Manufacturing Organization (CDMO), and Optieum Biotechnologies (Optieum), a preclinical stage company dedicated to the discovery and development of innovative Chimeric Antigen Receptor (CAR) T cell therapies, reported a partnership for cGMP manufacturing of OPTF01, Optieum’s novel CAR-T therapy for glioblastoma treatment, a product derived from their proprietary Eumbody System (Press release, Optieum Biotechnologies, MAY 8, 2025, View Source [SID1234652786]).

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OPTF01 specifically targets Fibroblast activation protein-alpha (FAPα) a protein expressed on both tumor cells and the surrounding pericytes and Cancer-associated Fibroblasts (CAFs). Hence, OPTF01 can potentially disrupt the immunosuppressive microenvironment around the tumor while simultaneously attacking the malignant cells within the tumor. Successful development of this therapeutic approach would address a critical unmet medical need for patients with refractory glioblastoma who currently face limited treatment options with poor prognoses, as well as various other solid tumor indications.

Under this collaboration, Cellipont Bioservices will provide the technology transfer, process development, and cGMP manufacturing of Optieum’s novel OPTF01 CAR-T product. "Glioblastoma remains one of the most aggressive and difficult-to-treat cancers, demanding urgent innovation beyond traditional approaches," said Darren Head, CEO of Cellipont Bioservices. "Our collaboration with Optieum presents an exciting opportunity to leverage advanced CAR-T technologies and bring meaningful solutions to patients in need. We are honored to be part of this critical mission."

Shun Nishioka, CEO of Optieum added, "At Optieum, we are committed to redefining the future of CAR-T therapy through relentless innovation and scientific rigor. Partnering with Cellipont’s team of experts ensures that our groundbreaking therapies are manufactured to the highest standards, accelerating our progress toward delivering next-generation therapies for glioblastoma and other solid tumors."

OPTF01 is derived from the Eumbody System, a proprietary platform representing a significant advancement in CAR-T cell therapy development. This platform leverages rapid and expansive functional screening to identify and optimize CAR constructs in unprecedented fashion. By dynamically harmonizing single-chain variable fragment (scFv) sequences to enhance the functional capabilities of T cells, the Eumbody System sets a new standard in CAR-T innovation.

On May 8, 2025 Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, reported business highlights and financial results for the first quarter ended March 31, 2025 (Press release, Arcellx, MAY 8, 2025, View Source [SID1234652722]).

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"Delivering therapies that can positively impact patients’ lives is our mission," said Rami Elghandour, Arcellx’s Chairman and Chief Executive Officer. "We are pleased that minimal residual disease negativity has been added as a dual primary endpoint to the iMMagine-3 protocol in addition to progression-free survival. This addition is in line with the feedback provided by the Oncologic Drug Advisory Committee to the Food and Drug Administration during the March 2024 ODAC meeting, and we believe this is a significant advancement for multiple myeloma patients that will allow impactful therapies to reach patients earlier, saving more lives. Additionally, we are on track to present updated data on all 117 patients dosed in iMMagine-1 at the European Hematology Association (EHA) (Free EHA Whitepaper) meeting on Saturday, June 14, 2025, in Milan. As we accelerate toward becoming a commercial organization with the planned launch of anito-cel in 2026, we added two Board members, Andrew Galligan and Kristin Myers, who bring relevant launch and scale expertise. It’s an inspiring time at Arcellx! We continue to attract outstanding talent who recognize the opportunity to play a part in advancing our category-defining therapy and value our diverse and inclusive culture, which allows them to do what they do best every day. I’m proud to work alongside such a talented team as we build on our unique culture while keeping patients centered at the core of what we do."

Recent Business Progress
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iMMagine-1 data accepted for oral presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress.

Date: Saturday, June 14, 2025

Time: 17:00-18:15 CEST

Session: Treatment of Relapsed and/or Multiple Myeloma

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Minimal Residual Disease (MRD) negativity was added as a dual primary endpoint in addition to progression-free survival in the global Phase 3, randomized controlled iMMagine-3 clinical study. The iMMagine-3 study was initiated in the second half of 2024 at approximately 130 study sites across North America, Europe, and the rest of the world. Anito-cel is partnered with Kite, a Gilead Company.

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Appointed Andrew Galligan and Kristin Myers to Board of Directors.

Most recently, Mr. Galligan served as Chief Financial Officer at Nevro Corp., a medical device company in the implantable spinal cord stimulation market. During his 10-year tenure at Nevro, he built the finance and operations group from commercial launch and drove year-over-year revenue growth. Prior to that, he was Vice President, Finance, and Chief Financial Officer at Ooma, Inc., where he currently serves as a board member. Before that, he served in the same executive capacity at Reliant Technologies, Inc. and helped complete the acquisition of the company by Thermage, Inc. Mr. Galligan’s biotechnology industry executive experience also includes senior financial leadership roles at Metrika Inc. (acquired by Bayer), Corcept Therapeutics Incorporated, and Amira Medical (acquired by Roche). He holds a Business Studies degree from Trinity College, Dublin University, Dublin, Ireland and is a Fellow of the Irish Institute of Chartered Accountants.

Ms. Myers brings 20+ years of healthcare experience, including senior leadership roles across the payer, provider and medtech sectors. Currently, she serves as the Chief Operating Officer at Blue Cross Blue Shield Association, leading strategic, operational and technology teams to support the BCBS System. Prior to this, Ms. Myers founded and led Hopscotch Primary Care as the CEO, standing up primary care centers to serve vulnerable patient populations across rural America. Previously, Ms. Myers held several positions of increasing responsibility at Aetna, beginning as Chief of Staff to the CEO and Chairman, and eventually rising to President of the Great Lakes Region. Ms. Myers’ career also included time in venture capital investing in the healthcare and biotech sectors. She holds an MBA from Harvard Business School and a BS in Biomedical Engineering from the University of Wisconsin-Madison.

First Quarter 2025 Financial Highlights

Cash, cash equivalents, and marketable securities:

As of March 31, 2025, Arcellx had cash, cash equivalents, and marketable securities of $565.2 million. Arcellx anticipates that its cash, cash equivalents, and marketable securities will fund its operations into 2028.

Collaboration revenue:

Collaboration revenue was $8.1 million and $39.3 million for the quarters ended March 31, 2025 and 2024, respectively, a decrease of $31.2 million. This decrease was primarily driven by completion of dosing and manufacturing of anito-cel in the iMMagine-1 trial in the fourth quarter of 2024.

R&D expenses:

Research and development expenses were $50.8 million and $32.3 million for the quarters ended March 31, 2025 and 2024, respectively, an increase of $18.5 million. This increase was primarily driven by increased costs relating to other clinical and preclinical pipeline programs and increased personnel costs, which includes non-cash stock-based compensation expense.

G&A expenses:

General and administrative expenses were $26.2 million and $22.7 million for the quarters ended March 31, 2025 and 2024, respectively, an increase of $3.5 million. This increase was primarily driven by increased personnel costs, which includes non-cash stock-based compensation expense.

Net income or loss:

Net loss was $62.3 million and $7.2 million for the quarters ended March 31, 2025 and 2024, respectively.

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 Terns Pharmaceuticals, Inc. ("Terns" or the "Company") (Nasdaq: TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology and obesity, reported financial results for the first quarter ended March 31, 2025, and provided corporate updates (Press release, Terns Pharmaceuticals, MAY 8, 2025, View Source [SID1234652769]).

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"Terns had a strong start to 2025, marked by continued excellent execution on our two lead clinical programs. The dose escalation portion of the TERN-701 Phase 1 study for CML was completed in less than a year, and we are thrilled to report that we have initiated enrollment in the dose expansion portion of the study," stated Amy Burroughs, chief executive officer of Terns. "The rapid enrollment in our Phase 2 FALCON trial of TERN-601 in obesity highlights strong interest from patients and clinical investigators in the differentiated profile of this oral small molecule GLP1-RA. We remain on track to deliver meaningful data from both these studies in the second half of this year and have a cash runway that extends into 2028."

"TERN-701 showed highly encouraging safety with no dose limiting toxicities in dose escalation up to the maximum dose of 500 mg, linear pharmacokinetics with once daily dosing, and compelling molecular responses in patients with high CML disease burden who had responded poorly to multiple prior therapies including asciminib," said Emil Kuriakose MD, chief medical officer of Terns. "The favorable safety profile and dose-related increase in molecular responses with TERN-701 allowed us to select doses at the top end of the dose range to take forward to dose expansion."

Recent Clinical Pipeline Developments and Anticipated Milestones

TERN-701: Oral, small-molecule next-generation allosteric BCR-ABL inhibitor for chronic myeloid leukemia (CML)

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In April 2025, Terns enrolled the first patient in the dose expansion portion of the Phase 1 CARDINAL study of TERN-701 for CML. Patients will be randomized to one of two dose cohorts (320 mg or 500 mg QD) with up to 40 patients per arm. Doses were selected based on the totality of safety, efficacy, and PK/PD data from dose escalation
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Terns plans to report additional safety and efficacy data from the dose escalation and expansion portions of the study in 4Q 2025, when the study has sufficient patient enrollment and duration of follow-up to meaningfully assess 6-month major molecular response rates (regulatory approval endpoint) and inform the path to a pivotal trial
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In December 2024, Terns announced interim data from the TERN-701 dose escalation portion of the study, showing:
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Starting at the lowest dose, compelling molecular responses in heavily pre-treated CML patients with high baseline BCR-ABL transcript levels
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Encouraging safety profile with no dose limiting toxicities, adverse event-related treatment discontinuations or dose reductions at any dose

TERN-601: Oral, small-molecule glucagon-like peptide-1 (GLP-1) receptor agonist for obesity

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Key objectives of the FALCON Phase 2 trial are to demonstrate competitive weight loss at 12-weeks, a class-leading safety/tolerability profile, and the simplest dose titration amongst GLP1-RA therapies
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The FALCON Phase 2 trial is ongoing with top-line 12-week data expected in 4Q 2025
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U.S.-based, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of TERN-601
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Once-daily dosing with or without food in adults with obesity or who are overweight, without diabetes (BMI ranges from ≥30 to <50 kg/m2 or ≥27 to <30 kg/m2 with at least one weight-related comorbidity)
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Patients randomized to one of four active cohorts (n=30 per cohort): 250 mg, 500 mg, 500 mg slow titration, 750 mg or placebo
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Primary endpoint is percent change from baseline in body weight compared to placebo over 12 weeks
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Secondary endpoints include safety, tolerability and proportion of patients achieving 5% weight loss or greater
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Doses and titration schema for the Phase 2 were selected based on positive results from the Phase 1 study, announced in September 2024, which demonstrated weight loss over 28-days up to 5.5% and favorable safety and tolerability despite rapid dose titration every three days

Pipeline and Partnering Programs

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TERN-800 Series: Oral, small-molecule glucose-dependent insulinotropic polypeptide receptor (GIPR) antagonist
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Terns is prioritizing its discovery efforts on nominating a GIPR antagonist development candidate based on in-house discoveries and growing scientific rationale supporting the potential of GLP-1 agonist/GIPR antagonist combinations for obesity

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TERN-501: Oral, thyroid hormone receptor-beta (THR-β) agonist
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Based on non-clinical studies, THR-β is a complementary mechanism to GLP-1, potentially providing broader metabolic and liver benefits in addition to increased weight loss

Corporate Updates

Members of Terns’ senior leadership team will participate in the following upcoming investor conferences:

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Jefferies Global Healthcare Conference in New York City, New York being held June 3rd – June 5th, 2025
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Goldman Sachs 46th Annual Global Healthcare Conference in Miami, Florida being held June 9th – June 11th, 2025

Webcasts of these events can be accessed at the Terns website under the "Events & Presentations" tab on the "Investors" section of the Company’s website on the day of the event: View Source

First Quarter 2025 Financial Results

Cash Position: As of March 31, 2025, cash, cash equivalents and marketable securities were $334.3 million, as compared with $358.2 million as of December 31, 2024. Based on its current operating plan, Terns expects these funds will be sufficient to support its planned operating expenses into 2028.

Research and Development (R&D) Expenses: R&D expenses were $18.7 million for the quarter ended March 31, 2025, as compared with $18.6 million for the quarter ended March 31, 2024.

General and Administrative (G&A) Expenses: G&A expenses were $8.7 million for the quarter ended March 31, 2025, as compared with $6.9 million for the quarter ended March 31, 2024.

Net Loss: Net loss was $23.9 million for the quarter ended March 31, 2025, as compared with $22.4 million for the quarter ended March 31, 2024.