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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"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
•
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

•
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.

•
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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"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)

•
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
•
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
•
In December 2024, Terns announced interim data from the TERN-701 dose escalation portion of the study, showing:
o
Starting at the lowest dose, compelling molecular responses in heavily pre-treated CML patients with high baseline BCR-ABL transcript levels
o
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

•
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
•
The FALCON Phase 2 trial is ongoing with top-line 12-week data expected in 4Q 2025
o
U.S.-based, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of TERN-601
o
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)
o
Patients randomized to one of four active cohorts (n=30 per cohort): 250 mg, 500 mg, 500 mg slow titration, 750 mg or placebo
o
Primary endpoint is percent change from baseline in body weight compared to placebo over 12 weeks
o
Secondary endpoints include safety, tolerability and proportion of patients achieving 5% weight loss or greater
•
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

•
TERN-800 Series: Oral, small-molecule glucose-dependent insulinotropic polypeptide receptor (GIPR) antagonist
o
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

•
TERN-501: Oral, thyroid hormone receptor-beta (THR-β) agonist
o
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:

•
Jefferies Global Healthcare Conference in New York City, New York being held June 3rd – June 5th, 2025
•
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.

On May 8, 2025 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported that it will present multiple datasets in breast cancer together with its collaborators at the 2025 ESMO (Free ESMO Whitepaper) Breast Cancer Annual Congress in Munich, Germany, taking place from May 14-17, 2025 (Press release, Natera, MAY 8, 2025, View Source [SID1234652787]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Results from the I-SPY 2 clinical trial, sponsored and operated by Quantum Leap Healthcare Collaborative, will be shared in a mini-oral presentation on May 16, 2025. The report includes data from 712 patients with early-stage, high-risk breast cancer, and it evaluates the association of distant recurrence free survival (DRFS) with ctDNA concentration at diagnosis, before receiving neoadjuvant systemic therapy and curative-intent surgery. Key highlights include:

Signatera positive patients at diagnosis had 3x higher risk of recurrence than Signatera negative patients (HR 3.1, p< 0.001%), though the risk can be significantly reduced based on response to subsequent therapy.
Patients who were Signatera negative at diagnosis had extremely good outcomes.
Among patients who were Signatera positive at diagnosis, higher ctDNA quantities at the time of diagnosis were significantly correlated with a higher risk of recurrence. However, effective treatment can affect ctDNA levels as well as pathologic response status, both of which further refine risk of recurrence. This is the first time that pre-treatment absolute ctDNA quantity has been shown to correlate with clinical outcomes in breast cancer.
Among all clinicopathologic risk factors available at diagnosis, a multivariate analysis identified Signatera status as the most significant factor in predicting DRFS, regardless of disease subtype (p<0.001). DRFS prediction can be further refined by integrating additional variables before, during, and after treatment, including ctDNA dynamics.
"The I-SPY 2 trial is uncovering insights that may allow us to tailor treatment plans for breast cancer patients based on their individual genomic profiles and better identify patients who may be more likely to experience adverse outcomes," said Laura Esserman, M.D., MBA, and Laura van ‘t Veer, Ph.D., professors at the University of California, San Francisco, and principal investigators of the I-SPY 2 study. "Our hope is that these findings will encourage future interventional trials in breast cancer, specifically in the neoadjuvant setting."

"Signatera was able to predict excellent clinical outcomes in a high risk population at the time of diagnosis," said Angel Rodriguez, M.D., medical director, oncology at Natera. "This may give rise to new protocols, evaluating whether some patients can avoid chemotherapy or other intensive treatments, if they test Signatera-negative at diagnosis."

Natera will present an additional three abstracts at the ESMO (Free ESMO Whitepaper) Breast conference, highlighting real-world evidence and genomic landscaping from its multi-modal database of de-identified clinical and genomic data in over 200,000 early- and late-stage cancer patients.

Full list of Natera’s ESMO (Free ESMO Whitepaper) Breast presentations:

May 16, 9:40 AM CT | FPN 5MO
Presenter: Mark Magbanua, Ph.D., UCSF Helen Diller Family Comprehensive Cancer Center
Pretreatment Circulating Tumor (ct)DNA Predicts Metastatic Recurrence in Patients (pts) With High-Risk Early Breast Cancer (eBC) Enrolled in the I-SPY 2 Trial

May 15, 12:00 PM CT | FPN 115P
Presenter: Chu-Ling Yu, Merck
Real-World Testing Patterns of Circulating Tumor DNA (ctDNA) in Early-Stage Triple-Negative Breast Cancer (TNBC): a U.S. Nationwide Database Study

May 15, 12:00 PM CT | FPN 12P
Presenter: Melinda Telli, M.D., Stanford University School of Medicine
Real-world experience of longitudinal circulating tumor (ct)DNA monitoring in patients (pts) with early-stage triple-negative breast cancer (TNBC)

May 15, 12:00 PM CT | FPN 412TiP
Presenter: Thibault De La Motte Rouge, M.D., Ph.D., Comprehensive Cancer Centre Eugène Marquis (Rennes, France)
HEROES: De-escalation of medical therapies in HER2-positive metastatic breast cancer in long-term persistent response and minimal residual disease undetectable in circulating tumor DNA

May 15, 12:00 PM CT | FPN 37P
Presenter: Marla Lipsyc-Sharf, M.D., UCLA Health
Genetic Ancestry and Tumor Mutations Influence Circulating Tumor DNA (ctDNA) Detection Rates in Breast Cancer: A Large Real-World Study

May 15, 12:00 PM CT | FPN 93P
Presenter: Yara Abdou, M.D., UNC School of Medicine
Assessment of antibody-drug conjugate utilization in patients with breast cancer undergoing circulating tumor DNA testing

About Signatera

Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard of care tools, and help optimize treatment decisions. The test is available for clinical and research use and has coverage by Medicare across a broad range of indications. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in more than 100 peer-reviewed papers.

On May 8, 2025 Autolus Therapeutics plc (Nasdaq: AUTL), an early commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, reported its operational and financial results for the first quarter ended March 31, 2025 (Press release, Autolus, MAY 8, 2025, View Source [SID1234652733]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"We had a great first quarter of launch and are highly encouraged by physician enthusiasm for AUCATZYL in the U.S. We believe this speaks to the product profile and significant unmet need for patients," said Dr. Christian Itin, Chief Executive Officer of Autolus. "Building on that momentum in the U.S., we recently obtained marketing authorization from the UK’s MHRA, and we are working in collaboration with National Institute for Health and Care Excellence (NICE) to bring this much-needed therapy to patients in the UK. Our goal to expand into new markets is underpinned by our proprietary manufacturing and commercial infrastructure which has positioned us for strong execution."

"In the second quarter we are planning to share longer-term follow-up data from the FELIX study, and in the second half of the year we plan to announce data from the pediatric PY1 trial. Building on strong data with obe-cel in r/r B-ALL, we are looking beyond ALL and recently highlighted at an R&D investor event our potential for value creation driven by obe-cel in autoimmune diseases, including lupus nephritis (LN) and multiple sclerosis (MS). Supporting our plans to pursue LN, we reported encouraging early clinical data that show obe-cel’s potential to treat advanced and relapsed lupus patients. We have aligned with the U.S. Food and Drug Administration (FDA) on a compact Phase 2 trial design and potential registrational path to approval and we look forward to dosing the first patient in the Phase 2 trial before year-end."

Key updates and anticipated milestones:

AUCATZYL Launch
Autolus reported Q1 2025 net product sales of $9.0 million.
The Company has 39 centers fully activated in the U.S. as of May 7, 2025.
Patient access to AUCATZYL continues to increase, with coverage secured for approximately 90% of total U.S. medical lives.
On April 1, 2025, the Centers for Medicare and Medicaid Services (CMS) included AUCATZYL in their published Healthcare Common Procedure Coding System (HCPCS) coding determinations and Hospital Outpatient Prospective Payment System (OPPS) payment rates, formalizing reimbursement for patients on government programs. The CMS policy splits the therapeutic dose of AUCATZYL into two administrations for coding and billing purposes. The Company is working with the treatment centers on implementing the coding and payment policy from CMS and is assessing any potential impact on the timing of revenue recognition.
On April 25, 2025, the UK Medicines and Healthcare products Regulatory Agency (MHRA) granted conditional marketing authorization for AUCATZYL (obecabtagene autoleucel) for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL). The Company will work with the National Institute for Health and Care Excellence (NICE) on patient access to therapy and a meeting is planned for May 2025.
Obe-cel is under regulatory review in the EU and the Company expects to receive notification of approval status from the European Medicines Agency (EMA) in the second half of 2025.

Obe-cel in lupus nephritis (LN)
Preliminary data from the Phase 1 dose confirmation clinical trial (CARLYSLE) in refractory systemic lupus erythematosus (SLE) patients were reported on April 23, 2025, and support progressing into a planned Phase 2 pivotal study. Out of six patients in the cohort, three patients had complete renal response, all by month three. Complement normalized in all patients by month one. Rash, alopecia and mucosal ulcers resolved by month three and arthritis resolved by month one in all patients. Data show high peak expansion and deep B cell aplasia consistent with known obe-cel characteristics in oncology indications. No dose limiting toxicities (DLTs) or immune effector cell-associated neurotoxicity syndrome (ICANS) were observed in the study to date. Grade one cytokine release syndrome (CRS) was observed in three out of six patients. Hypertension, a typical sign of advanced lupus nephritis, pre-existed in three patients. On study, five of six patients experienced a transient hypertension, including Grade 3, well managed by anti-hypertensive agents.
The Company has aligned with U.S. Food and Drug Administration (FDA) on the Phase 2 trial design and potential registrational path to approval and anticipates dosing the first patient in a Phase 2 trial before the end of 2025.
Full data with longer term follow-up from the Phase 1 CARLYSLE clinical trial is targeted for presentation at a medical conference in the second half of 2025.

Obe-cel in progressive MS
Autolus plans to advance obe-cel into clinical development in progressive MS. The Company expects to dose its first patient in a Phase 1 dose escalation study by year-end 2025.
Early-stage pipeline programs and collaborations support longer-term growth
Autolus’ translational programs with UCL continue to fuel its early-stage pipeline, providing a cost-efficient path to development.
Summary of Anticipated News Flow:

ALL: FELIX clinical trial longer-term follow up Mid-Year
ALL: Notification from EU EMA regarding approval in r/r adult ALL H2 2025
ALL: PY01 trial in pediatric ALL first clinical data H2 2025
SLE: Phase 1 CARLYSLE trial presentation at medical conference H2 2025
LN: Expect to dose first patient in Phase 2 trial By year-end 2025
MS: Expect to dose first patient in Phase 1 trial in progressive MS
By year-end 2025
ALA: Expect to dose first patient in Phase 1 trial in AL amyloidosis By year-end 2025

ALL: adult lymphoblastic leukemia
SLE: systemic lupus erythematosus
LN: lupus nephritis
MS: multiple sclerosis
ALA: light-chain amyloidosis

Financial Results for the Quarter Ended March 31, 2025

Product revenue, net for the three months ended March 31, 2025 was $9.0 million.

Cost of sales for the three months ended March 31, 2025 totaled $18.0 million. This amount includes the cost of all commercial product delivered to the authorized treatment centers, including product delivered but not yet recorded as product revenue which is captured as deferred revenue. Additionally, cost of sales includes any cancelled orders in the period, patient access program product, and 3rd party royalties for certain technology licenses.

Research and development expenses decreased from $30.7 million to $26.7 million for the three months ended March 31, 2025, compared to the same period in 2024. This change was primarily due to commercial manufacturing related employee and infrastructure cost shifting to cost of sales and inventory, partially offset by an increase in obe-cel clinical trial and supply costs.

Selling, general and administrative expenses increased from $18.2 million to $29.5 million for the three months ended March 31, 2025, compared to the same period in 2024. This increase was primarily due to salaries and other employment-related costs, driven by increased headcount supporting U.S. commercialization activities.

Loss from operations for the three months ended March 31, 2025 was $65.2 million, as compared to $38.8 million for the same period in 2024.

Net loss was $70.2 million for the three months ended March 31, 2025, compared to $52.7 million for the same period in 2024. Basic and diluted net loss per ordinary share for the three months ended March 31, 2025, totaled $(0.26), compared to basic and diluted net loss per ordinary share of $(0.24) for the same period in 2024.

Cash, cash equivalents and marketable securities at March 31, 2025, totaled $516.6 million, as compared to $588.0 million at December 31, 2024. The decrease was primarily driven by net cash used in operating and investing activities and impacted by a delayed cash receipt of approximately $20 million in R&D tax credit expected from the UK HMRC.

Autolus estimates that, with its current cash and cash equivalents and marketable securities, the Company is well capitalized to drive the launch and commercialization of obe-cel in r/r B-ALL and to obtain data in the LN pivotal trial and MS Phase 1 trial.

Financial Results for the Period Ended March 31, 2025
Selected Consolidated Balance Sheet Data
(In thousands)

March 31 December 31
2025 2024
Assets
Cash and cash equivalents $ 95,799 $ 227,380
Marketable securities – Available-for-sale debt securities $ 420,776 $ 360,643
Total current assets $ 615,773 $ 660,929
Total assets $ 746,338 $ 782,725
Liabilities and shareholders’ equity
Total current liabilities $ 66,615 $ 60,743
Total liabilities $ 375,230 $ 355,400
Total shareholders’ equity $ 371,108 $ 427,325

Selected Consolidated Statements of Operations and Comprehensive Loss Data
(In thousands, except share and per share amounts)

Three months ended March 31,
2025 2024
Product revenue, net $ 8,982 $ —
License revenue — 10,091
Cost and operating expenses:
Cost of sales (17,951 ) —
Research and development expenses, net (26,734 ) (30,671 )
Selling, general and administrative expenses (29,534 ) (18,177 )
Loss on disposal of property and equipment (3 ) —
Loss from operations (65,240 ) (38,757 )
Total other expenses, net (2,696 ) (13,941 )
Net loss before income tax (67,936 ) (52,698 )
Income tax (expense) benefit (2,225 ) 8
Net loss attributable to ordinary shareholders (70,161 ) (52,690 )
Other comprehensive income, net of tax 11,068 58
Total comprehensive loss $ (59,093 ) $ 52,632 )

Basic and diluted net loss per ordinary share $ (0.26 ) $ (0.24 )
Weighted-average basic and diluted ordinary shares 266,126,548 222,170,707

Conference Call
Management will host a conference call and webcast today at 8:30am EDT/13:30pm BST to discuss the company’s financial results. Conference call participants should pre-register using this link to receive the dial-in numbers and a personal PIN, which are required to access the conference call. A simultaneous audio webcast and replay will be accessible on the events section of Autolus’ website at View Source