On November 3, 2025 Orum Therapeutics ("Orum" or the "Company") (KRX: 475830), a public biotechnology company pioneering the field of degrader-antibody conjugates (DACs), reported that preclinical data for ORM-1153, a CD123-targeting DAC with a GSPT1-degrading payload, have been selected for presentation at the upcoming 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, taking place December 6 to 9, 2025, in Orlando, Florida.

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The presentation will feature data from preclinical studies of ORM-1153, a novel CD123-targeting DAC designed to deliver Orum’s proprietary GSPT1-degrading payload, SMol006, selectively into cancer cells to achieve targeted protein degradation and antitumor activity in acute myeloid leukemia (AML). The results support further investigation of ORM-1153 as a potential therapeutic option for AML and other CD123-positive hematologic malignancies, including those with TP53-mutant status.

Details of the ASH (Free ASH Whitepaper) 2025 Presentation

Title: ORM-1153: A CD123-Targeting Degrader Antibody Conjugate with GSPT1-Degrading Payload Exhibits Potent Preclinical Antitumor Activity in Acute Myeloid Leukemia

Session: 604. Molecular Pharmacology and Drug Resistance: Myeloid Neoplasms: Poster III

Session Type: Poster Presentation

Session Date and Time: December 8, 2025, from 6 pm to 8 pm ET

Location: Orange County Convention Center (OCCC), West Halls B3-B4

Abstract Number: 5051

About Orum’s TPD² Approach

Orum’s unique Dual-Precision Targeted Protein Degradation (TPD²) approach builds novel targeted protein degraders combined with the precise cell delivery mechanisms of antibodies to generate innovative, first-in-class, cell-selective TPDs for the treatment of cancer and other serious diseases. Orum has developed new targeted protein degrader payloads to specifically degrade an intracellular target protein within cancer cells via the E3 ubiquitin ligase pathway. Conjugated to antibodies, the payloads are designed to be delivered specifically to target cells and precisely degrade the intracellular target protein of interest.

(Press release, Orum Therapeutics, NOV 3, 2025, View Source [SID1234659273])

On November 3, 2025 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, reported that Paul Peter Tak, M.D., Ph.D., FMedSci, Candel’s President and Chief Executive Officer, will present at the Jefferies Global Healthcare Conference, being held on November 17-20, 2025 in London, United Kingdom.

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Presentation Details:

Date: Tuesday, November 18, 2025
Time: 8:00-8:25 AM GMT / 4:00-4:25 AM ET
Webcast Link: Jefferies / Candel Presentation

A webcast of the presentation will be available by selecting Events and Presentations under the News & Events tab in the Investors section at www.candeltx.com. A replay of the webcast will be archived for up to 90 days following the session date.

(Press release, Candel Therapeutics, NOV 3, 2025, View Source [SID1234659291])

On November 3, 2025 Incyte (Nasdaq:INCY) reported that data from key programs in its oncology portfolio will be presented in both oral and poster sessions at the 2025 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, to be held December 6 – 9, 2025, in Orlando.

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"This year’s Incyte presentations highlight the potential of our portfolio to transform the treatment of blood cancers, specifically for patients with myeloproliferative neoplasms (MPNs)," said Pablo J. Cagnoni, M.D., President and Head of Research and Development, Incyte. "New data for our first-in-class mutCALR-targeted monoclonal antibody, INCA033989, as a monotherapy in patients with myelofibrosis (MF) who are intolerant or refractory to ruxolitinib, and in combination with ruxolitinib in patients with MF who experience a suboptimal response to ruxolitinib monotherapy will be highlighted as an oral presentation. Updated data for INCA033989 in essential thrombocythemia (ET) will also be presented. Additionally, we look forward to sharing the results from axatilimab in graft-versus-host disease (GVHD) and tafasitamab in follicular lymphoma (FL) – all of which showcase the progress and promise of our oncology portfolio."

Details on Incyte data presentations at ASH (Free ASH Whitepaper) include:

Oral Presentations

INCA033989 (mutCALR)

Molecular Characterization Of Patients (Pts) With Myeloproliferative Neoplasms Treated With INCA033989 Demonstrates Selective Targeting Of CALR Mutant Hematopoietic Cells
(Session Title: 631. Myeloproliferative Syndromes and Chronic Myeloid Leukemia: Basic and Translational: Precision Targeting in MPN. [December 6, 9:30 – 11:00 a.m. ET]. Publication #71.)

Safety And Efficacy Of The Mutant Calreticulin-Specific Monoclonal Antibody INCA033989 As Monotherapy Or In Combination With Ruxolitinib In Patients (Pts) With Myelofibrosis (MF): Preliminary Results From Dose Escalation Of Two Global Phase 1 Studies
(Session Title: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Between a Rock and a Ropeg – Innovative Therapies for MPNs. [December 7, 9:30 – 11:00 a.m. ET]. Publication #484.)

Safety And Efficacy Of INCA033989, A Novel First In Class Mutant Calreticulin-Specific Monoclonal Antibody, In Patients With Essential Thrombocythemia
(Session Title: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Drivers and Mast Cells and Blasts, Oh My! – Insights and Treatments for MPNs and Mastocytosis. [December 8, 4:30 – 6:00 p.m. ET]. Publication #1024.)

Axatilimab (Niktimvo)

Safety And Feasibility Of 0.6 mg/kg Every 4 Weeks Dosing Of Axatilimab In Patients Treated In The AGAVE-201 Study
(Session Title: 722. Allogeneic Transplantation: Acute and Chronic GVHD and Immune Reconstitution: Acute and Chronic GVHD and Immune Reconstitution. [December 6, 2:00 – 3:30 p.m. ET]. Publication #272.)

INCB057643 (BET)

Safety And Efficacy Of Bromodomain And Extra-Terminal Protein Inhibitor INCB057643 Monotherapy In Patients With Relapsed Or Refractory Myelofibrosis And Other Advanced Myeloid Neoplasms: A Phase 1 Study
(Session Title: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Beyond JAK Inhibition – Therapeutic Innovation and Transplant Strategies in Myelofibrosis. [December 8, 2:45 – 3:00 p.m. ET]. Publication #907)

Ruxolitinib (Jakafi)

Risk Factors For Progressive Kidney Impairment Among Patients With Polycythemia Vera (PV) Are Recapitulated And Treatable In Mouse Models Of PV
(Session Title: 908. Outcomes Research: Myeloid Malignancies: Treatment and Outcomes in the Real-World. [December 7, 12:00 – 1:30 p.m. ET]. Publication #605.)

Poster Presentations

Axatilimab (Niktimvo)

Pharmacodynamic Analysis Of AGAVE-201 Indicates Changes In CSF-1R–Expressing Cells And Associated Biomarkers Potentially Contributing To Chronic Graft-Versus-Host Disease Resolution
(Session Title: 722. Allogeneic Transplantation: Acute and Chronic GVHD and Immune Reconstitution: Poster I. [December 6, 5:30 – 7:30 p.m. ET]. Publication #2458.)

Trial In Progress: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Of Axatilimab And Corticosteroids As Initial Treatment For Moderate To Severe Chronic Graft-Versus-Host Disease
(Session Title: 722. Allogeneic Transplantation: Acute and Chronic GVHD and Immune Reconstitution: Poster II. [December 7, 6:00 – 8:00 p.m. ET]. Publication #4256.)

Long-Term Treatment Duration And Safety Of Axatilimab Among Patients With Chronic Graft-Versus-Host Disease In AGAVE-201
(Session Title: 722. Allogeneic Transplantation: Acute and Chronic GVHD and Immune Reconstitution: Poster III. [December 8, 6:00 – 8:00 p.m. ET]. Publication #6010.)

Safety Analysis Of Axatilimab In Patients With Chronic Graft-Versus-Host Disease In An Expanded Access Program
(Session Title: 722. Allogeneic Transplantation: Acute and Chronic GVHD and Immune Reconstitution: Poster III. [December 8, 6:00 – 8:00 p.m. ET]. Publication #6008.)

Axatilimab In Combination With Ruxolitinib In Patients With Newly Diagnosed Chronic Graft-Versus-Host Disease: Interim Safety Analysis Of A Randomized, Phase 2 Study
(Session Title: 722. Allogeneic Transplantation: Acute and Chronic GVHD and Immune Reconstitution: Poster III. [December 8, 6:00 – 8:00 p.m. ET]. Publication #6012.)

INCB000928 (ALK2)

The Activin Receptor-Like Kinase-2 Inhibitor Zilurgisertib (INCB000928) As Monotherapy Or With Ruxolitinib In Patients With Anemia Due To Myelofibrosis: Phase 1/2 Study Final Results
(Session Title: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster II. [December 7, 6:00 – 8:00 p.m. ET]. Publication #3795.)

INCB057643 (BET)

INCB057643, A Bromodomain And Extra-Terminal Protein Inhibitor, In Combination With Ruxolitinib In Patients With Myelofibrosis: A Phase 1 Study Of Safety And Efficacy
(Session Title: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster III. [December 8, 6:00 – 8:00 p.m. ET]. Publication #5574.)

INCB160058 (JAK2V617F)

INCB160058 Selectively Targets JAK2V617F-Driven Hematopoiesis In Diverse And Drug-Resistant Models Of Myeloproliferative Neoplasms
(Session Title: 604. Molecular Pharmacology and Drug Resistance: Myeloid Neoplasms: Poster II. [December 7. 6:00 – 8:00 p.m. ET]. Publication #3275.)

A Multicenter, Open-Label Phase 1 Study Of INCB160058, A First-In-Class JAK2V617F Mutant–Selective Inhibitor, In Patients With Myelofibrosis, Polycythemia Vera, Or Essential Thrombocythemia
(Session Title: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster I. [December 6, 5:30 – 7:30 p.m. ET]. Publication #2051.)

Ruxolitinib (Jakafi)

Impact Of Ruxolitinib On Corticosteroid Treatment Patterns In 1147 Patients With Chronic Graft-Versus-Host Disease In Real-World Practice In The United States: A Long-Term Follow-Up Analysis
(Session Title: 722. Allogeneic Transplantation: Acute and Chronic GVHD and Immune Reconstitution: Poster I. [December 6, 5:30 – 7:30 p.m. ET]. Publication #2452.)

Clinical And Disease Characteristics Of Initial Participants At Time Of Enrollment In THRIVE, A Prospective, Observational Cohort Study Of Patients At Risk For Chronic Graft-Versus-Host Disease
(Session Title: 722. Allogeneic Transplantation: Acute and Chronic GVHD and Immune Reconstitution: Poster I. [December 6, 5:30 – 7:30 p.m. ET]. Publication #2446.)

Ruxolitinib Duration Of Treatment And Effect On Phlebotomy Use Among 2369 Patients With Polycythemia Vera: A Real-World Analysis Of The Medicare Fee-For-Service Claims Database
(Session Title: 908. Outcomes Research: Myeloid Malignancies: Poster I. [December 6, 5:30 – 7:30 p.m. ET]. Publication #2826.)

Longitudinal Genomic Shifts Associated With Disease Transformation In Patients With Polycythemia Vera (PV) Enrolled In REVEAL
(Session Title: 631. Myeloproliferative Syndromes and Chronic Myeloid Leukemia: Basic and Translational: Poster II. [December 7, 6:00 – 8:00 p.m. ET]. Publication #3749.)

Identification Of Biomarkers To Predict Disease Progression Via Molecular Analysis Of Patients (Pts) With Low-Risk Myelofibrosis (MF) Enrolled In The MOST Study
(Session Title: 631. Myeloproliferative Syndromes and Chronic Myeloid Leukemia: Basic and Translational: Poster III. [December 8, 6:00 – 8:00 p.m. ET]. Publication #5526.)

Real-World Treatment Duration Of Ruxolitinib And Use Of Transfusion Among 2268 Patients With Myelofibrosis: An Analysis Of The Medicare Fee-For-Service Claims Database
(Session Title: 908. Outcomes Research: Myeloid Malignancies: Poster III. [December 8, 6:00 – 8:00 p.m. ET]. Publication #6391.)

Ruxolitinib XR

Bioequivalence Of Ruxolitinib Once-Daily Extended-Release Vs Twice-Daily Immediate-Release Tablets In Healthy Adults
(Session Title: 604. Molecular Pharmacology and Drug Resistance: Myeloid Neoplasms: Poster III. [December 8, 6:00 – 8:00 p.m. ET]. Publication #5045.)

Tafasitamab (Monjuvi)

Phase 3 Study (inMIND) Of Tafasitamab Plus Lenalidomide And Rituximab For Relapsed Or Refractory Follicular Lymphoma: Clinical Characteristics And Outcomes By Age
(Session Title: 623. Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster II. [December 7, 6:00 – 8:00 p.m. ET]. Publication #3582.)

Phase 3 Study (inMIND) Of Tafasitamab Plus Lenalidomide And Rituximab For Relapsed Or Refractory Follicular Lymphoma: Clinical Characteristics And Outcomes Of Patients Receiving Second-Line Treatment
(Session Title: 623. Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster I. [December 6, 5:30 – 7:30 p.m. ET]. Publication #1819.)

CD19 Expression Is Preserved Following CD19-Directed Monoclonal Antibody Therapy With Tafasitamab
(Session Title: 629. Aggressive Lymphomas, Immunotherapy Including Bispecific Antibodies: Poster III. [December 8, 6:00 – 8:00 p.m. ET]. Publication #5515.)

Phase 3 Study (inMIND) Of Tafasitamab Plus Lenalidomide And Rituximab For Relapsed Or Refractory Follicular Lymphoma: Clinical Characteristics And Outcomes Of High-Risk Patients
(Session Title: 623. Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster III. [December 8, 6:00 – 8:00 p.m. ET]. Publication #5367.)

All regular abstracts accepted for presentation at the ASH (Free ASH Whitepaper) Annual Meeting 2025 are available online via the ASH (Free ASH Whitepaper) website. More information regarding the 2025 ASH (Free ASH Whitepaper) Congress can be found at: View Source

Conference Call and Webcast
Incyte will host an investor event and webcast on Sunday, December 7, 2025, from 11:00 a.m.-12:30 p.m. ET to discuss key mutCALR data being presented at ASH (Free ASH Whitepaper).

The event will be webcasted and can be accessed via the Events and Presentations tab of the Investor section of Incyte.com and it will be available for replay for 30 days.

(Press release, Incyte, NOV 3, 2025, View Source [SID1234659307])

On November 3, 2025 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, reported that management will participate in two upcoming investor conferences.

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Guggenheim’s 2nd Annual Healthcare Innovation Conference on Tuesday, November 11. A live audio webcast of the presentation will be available here and on the Events and Presentations section of the Company’s website.
Jefferies London Healthcare Conference on Tuesday, November 18. A live audio webcast of the presentation will be available here and on the Events and Presentations section of the Company’s website.

(Press release, Arvinas, NOV 3, 2025, View Source [SID1234659242])

On November 3, 2025 Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme" or the "Company") reported its financial and operating results for the third quarter ended September 30, 2025 and provided an update on its recent corporate activities.

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"Halozyme delivered another record quarter, with royalty revenue increasing 52% year-over-year to $236 million. This strong performance drove total revenue to a record $354 million, representing a 22% increase year-over-year. The continued success of our three established ENHANZE-enabled blockbuster therapies, DARZALEX SC, Phesgo, and VYVGART Hytrulo, highlights the strength of our royalty driven business model. Further expanding our near and long term opportunity, notable achievements this quarter include two new indication approvals: DARZALEX SC for smoldering multiple myeloma in Europe and the argenx VYVDURA pre-filled syringe in Japan for gMG and CIDP. These events result in achievement to date of 13 of our 15 growth catalysts announced in Q1, which include new product approvals, geographic expansion, and key reimbursement wins across major markets. We project achievement of the two remaining catalysts in Q4. Building on the progress to date, we project the revenue growth contribution of our four additional launched ENHANZE product, Ocrevus Zunuvo, Tecentriq Hybreza, Opdivo Qvantig and Rybrevant SC to increase in 2026 and beyond," commented Dr. Helen Torley, President and CEO of Halozyme.

"Based on our continued strong performance of our core ENHANZE technology, we are pleased to raise our guidance ranges, with royalty revenue growth of approximately 50% for the full year. As we look ahead, our planned acquisition of Elektrofi represents a significant opportunity to amplify our opportunity in subcutaneous drug delivery by introducing a complementary high-concentration technology that has three large biopharma partner agreements in place. With royalty contributions from Elektrofi’s Hypercon projected to begin in 2030, we are building a multi-platform engine for long-term growth, positioning Halozyme to deliver sustained value for patients, partners, and our shareholders," said Dr. Torley.

Halozyme also announced today a transition plan under which Nicole LaBrosse, Senior Vice President and Chief Financial Officer (CFO) will continue as CFO until a new Chief Financial Officer is hired, or until March 30, 2026, and then, depart to pursue a new professional opportunity. An external search is being initiated to identify the successor.
"I thank Nicole for her contributions over the past four years as we delivered on our growth strategy," added Dr. Torley. "We look forward to our next chapter of growth, one in which a diverse range of capital market transactions and M&A will play a key role."

Third Quarter and Recent Corporate Highlights:
•In September 2025, Halozyme agreed to acquire Elektrofi, Inc. ("Elektrofi"), a biopharmaceutical company with an ultra-high concentration microparticle technology for biologics, branded Hypercon. Under the terms of the Agreement and Plan of Merger, Halozyme will acquire Elektrofi for $750 million in upfront consideration and up to three $50 million milestone payments contingent upon three separate product regulatory approvals. The transaction is expected to close in the fourth quarter of 2025, subject to completion of antitrust review under the Hart-Scott-Rodino Antitrust Improvements Act and other customary closing conditions.
•In June 2025, Halozyme initiated the third $250 million share repurchase tranche under the $750 million approved program from February 2024. As of September 30, 2025, $92.3 million has been used to repurchase approximately 1.7 million shares at an average price of $52.89 per share.

Third Quarter and Recent Partner Highlights:
•In September 2025, argenx received approval from the Ministry of Health, Labour and Welfare in Japan for VYVDURA prefilled syringe for self-injection for the treatment of adult patients with generalized myasthenia gravis and adult patients with chronic inflammatory demyelinating polyneuropathy.
•In July 2025, Janssen announced the European Commission approved a new indication for DARZALEX SC as a monotherapy for the treatment of adult patients with smouldering multiple myeloma at high risk of developing multiple myeloma.

Third Quarter 2025 Financial Highlights:
•Revenue was $354.3 million, compared to $290.1 million in the third quarter of 2024. The 22% year-over-year increase was primarily driven by royalty revenue growth and an increase in product sales, partially offset by a decrease in milestone revenues.
Revenue included $236.0 million in royalties, an increase of 52% compared to $155.1 million in the third quarter of 2024, primarily driven by continued sales uptake of ENHANZE partner products that have launched since 2020, predominantly by VYVGART Hytrulo by argenx, DARZALEX SC by Janssen and Phesgo by Roche in all geographies.
•Cost of sales was $55.2 million, compared to $49.4 million in the third quarter of 2024. The increase in cost of sales was primarily due to an increase in product sales, material scrap and labor allocation initiatives.
•Amortization of intangibles expense remained flat at $17.8 million, compared to the third quarter of 2024.

•Research and development expense was $17.3 million, compared to $18.5 million in the third quarter of 2024. The decrease in research and development expense was primarily due to lower compensation expense driven by resource optimization and labor allocation initiatives, and timing of planned investments in ENHANZE related to the development of our new high-yield rHuPH20 manufacturing process.
•Selling, general and administrative expense was $46.1 million, compared to $41.2 million in the third quarter of 2024. The increase was primarily due to an increase in consulting and professional service fees, including litigation costs incurred in connection with a patent infringement litigation case and diligence costs incurred in support of the planned acquisition of Elektrofi, partially offset by lower compensation expense.
•Operating income was $217.9 million, compared to $163.2 million in the third quarter of 2024.
•Net income was $175.2 million, compared to $137.0 million in the third quarter of 2024.
•Non-GAAP net income was $206.8 million, compared to $165.2 million in the third quarter of 2024.
•EBITDA was $238.3 million, compared to $183.6 million in the third quarter of 2024. Adjusted EBITDA was $248.2 million, compared to $183.6 million in the third quarter of 2024.1
•GAAP diluted earnings per share was $1.43, compared to $1.05 in the third quarter of 2024. Non-GAAP diluted earnings per share was $1.72, compared to $1.27 in the third quarter of 2024.1
•Cash, cash equivalents and marketable securities were $702.0 million on September 30, 2025, compared to $596.1 million on December 31, 2024. The increase was primarily a result of cash generated from operations, partially offset by share repurchase activities.

Financial Outlook for 2025
The Company is raising its 2025 financial guidance ranges, which were last updated on August 5th, 2025 excluding the impact of the accounting treatment of the Elektrofi transaction.
For the full year 2025, the Company expects:

•Total revenue of $1,300 million to $1,375 million, representing growth of 28% to 35% over 2024 total revenue, primarily driven by increases in royalty revenue. Revenue from royalties of $850 million to $880 million, representing growth of 49% to 54% over 2024.
•Adjusted EBITDA of $885 million to $935 million, representing growth of 40% to 48% over 2024.
•Non-GAAP diluted earnings per share of $6.10 to $6.50, representing growth of 44% to 54% over 2024. The Company’s earnings per share guidance does not consider the impact of potential future share repurchases.

(Press release, Halozyme, NOV 3, 2025, View Source [SID1234659258])