RegulationPriority Review (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (South Korea), Orphan Drug (Australia)

Structure/Sequence

Sequence Code 9075908L

Source: *****

Sequence Code 9075927H

Source: *****

Clinical Trials associated with Isatuximab-IRFC

NCT07479979

/ Not yet recruitingPhase 1/2IIT

Phase Ib/II Study of Selinexor in Combination With Carfilzomib, Subcutaneous Isatuximab Administered Via Investigational Device and Dexamethasone (SCID) for Patients With Relapsed and/or Relapsed Refractory Multiple Myeloma

The primary objective of this Phase Ib/II trial is to study the safety and tolerability of the combination of selinexor, carfilzomib, isatuximab-OBDS** and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma, who have received at least one line of therapy. The phase Ib portion comprises the safety run-in with 6-12 patients, with the option to reduce the selinexor dose from 40 mg to 20 mg if the higher dose reaches the prescribed toxicity threshold. The Phase II portion of the trial will test the Recommended Phase 2 Dose (RP2D) in an expansion cohort of up to 50 patients.

Start Date01 Jul 2026

Sponsor / Collaborator

Hoosier Cancer Research Network

[+3]

NCT07334535

/ Not yet recruitingPhase 4IIT

A Prospective, Randomized, Multi-center Study Comparing Isatuximab in Combination With VRD Versus VRD in High-Risk, Transplant-Ineligible Patients With Newly Diagnosed Multiple Myeloma.

This is a multicenter, prospective, randomized controlled trial designed to compare the quadruplet regimen of isatuximab, bortezomib, lenalidomide, and dexamethasone (Isa-VRD) with the standard triplet regimen (VRD) in newly diagnosed, transplant-ineligible patients with high-risk multiple myeloma (HRMM).
Primary Hypothesis:
The addition of isatuximab to VRD will significantly improve the MRD negativity rate at 12 months compared to VRD alone in HR-NDMM patients.
Secondary Hypotheses:
Isa-VRD will lead to higher overall response rates (ORR), deeper responses, and improved progression-free survival (PFS) and overall survival (OS).
The safety profile of Isa-VRD will be manageable and consistent with the known safety profiles of its individual components.

Start Date30 Jan 2026

Sponsor / Collaborator

Peking Union Medical College Hospital

[+14]

ChiCTR2600116772

/ Not yet recruitingPhase 4IIT

A multicenter prospective randomized controlled study of quadruplet regimen in newly diagnosed transplant-ineligible high-risk multiple myeloma patients

Start Date27 Oct 2025

Sponsor / Collaborator

Peking Union Medical College Hospital

[+1]

100 Clinical Results associated with Isatuximab-IRFC

100 Translational Medicine associated with Isatuximab-IRFC

100 Patents (Medical) associated with Isatuximab-IRFC

477

Literatures (Medical) associated with Isatuximab-IRFC

04 Mar 2026·Blood Cancer Discovery

First-line Therapy in Newly Diagnosed Multiple Myeloma

Review

Author: Usmani, Saad Z. ; Miller, Kevin C.

Abstract:

First-line multiple myeloma treatment has evolved from melphalan–prednisone to quadruplet regimens incorporating proteasome inhibitors, immunomodulatory drugs, anti-CD38 monoclonal antibodies, and autologous stem cell transplantation, yielding significantly improved survival. This review summarizes current approaches to risk stratification and therapy for newly diagnosed multiple myeloma and highlights the emerging role of measurable residual disease–adaptive strategies. We also discuss recent efforts to integrate chimeric antigen receptor T cells and bispecific antibodies into up-front treatment. As biology-driven strategies advance, select patients may achieve durable treatment-free remissions. Ongoing studies will clarify how to best tailor therapy while balancing efficacy, toxicity, and survivorship toward functional cures.

Significance::

Despite unprecedented advances, multiple myeloma therapy remains largely uniform and emphasizes indefinite treatment. Herein, although summarizing current standard-of-care therapy, we advocate for individualized approaches informed by disease biology, treatment response, and emerging biomarkers. Novel strategies incorporating immunotherapies are paving the way toward treatment-free remissions and functional cures in select patients.

01 Mar 2026·Annals of Clinical and Translational Neurology

Daratumumab Treatment for Chronic Inflammatory Demyelinating Polyradiculoneuropathy ( CIDP ): A Case Report

Article

Author: Hu, Xiaowei ; Li, Xiaowen ; Zhao, Jianli ; Li, Yu‐Jing ; Xiao, Zichun ; Wu, Jie ; Zhang, Xueyu ; Zhao, Xue ; Xu, Jing

ABSTRACT:

Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is an immune‐mediated neuropathy featuring progressive weakness, sensory deficits, and areflexia. While corticosteroids, intravenous immunoglobulin, and plasmapheresis are effective first‐line immunotherapies, a subset of patients remains treatment‐refractory. Daratumumab, an anti‐CD38 monoclonal antibody approved for multiple myeloma, demonstrates immunomodulatory effects suggesting utility in refractory neuroimmune disorders. However, evidence for its efficacy in CIDP remains limited. We report a case study of treatment‐refractory CIDP successfully managed with daratumumab, including 1 year follow‐up data.

20 Feb 2026·CHINESE MEDICAL JOURNAL

Real-world outcomes of isatuximab with pomalidomide and dexamethasone for relapsed and/or refractory multiple myeloma

Article

Author: Lin, Li’e ; Yan, Xiaojing ; An, Gang ; You, Jianhua ; Wang, Yingxue ; Liu, Jing ; Shen, Dan ; Tian, Weiwei ; Wang, Zhini ; Zhao, Weili ; Ding, Kaiyang ; Zhou, Lei ; Wang, Yafei ; Zhang, Xi ; Feng, Zhaoyi ; Fang, Baijun ; Chen, Wenting ; Chen, Wenming ; Xia, Weilin ; Liu, Gang

Abstract:

Background::

The isatuximab, pomalidomide, and dexamethasone (Isa-Pd) regimen has shown survival benefits for relapsed and/or refractory multiple myeloma (RRMM) in several trials, while evidence of effectiveness and safety among Chinese patients is limited. This study aimed to provide real-world evidence of Isa-Pd in Chinese patients with RRMM.

Methods::

In a prospective observational real-world study (IsaFiRsT), we enrolled Chinese RRMM patients who had received ≥2 prior therapies, including lenalidomide and proteasome inhibitors, and received the Isa-Pd regimen at Shanghai Jiaotong University School of Medicine, Ruijin-Hainan Hospital. A historical cohort of patients with RRMM who had received >1 additional line of treatment after ≥2 prior therapies was retrospectively included. The primary endpoint of the Isa-Pd cohort was the overall response rate (ORR). Inverse probability treatment weighting (IPTW) was used to balance confounding factors between the Isa-Pd cohort and historical cohort.

Results::

The Isa-Pd cohort comprised 24 patients with RRMM and reported an ORR of 82.6% (19/23, 95% confidence interval [CI]: 61.2% to 95.0%), a very good partial response or better rate of 73.9% (17/23) and a complete response or better rate of 43.5% (10/23). The median time to first response was 1.2 months (range: 0.9, 3.1 months). The median duration of response, progression-free survival (PFS), and overall survival (OS) were not reached, with a median follow-up of 8.4 months. The 6-month PFS and OS rates were 87.0% and 91.3%, respectively. The IPTW-adjusted ORR in the Isa-Pd cohort was 85.1% compared to 33.4% in the historical cohort, with a risk ratio of 2.55 (95% CI: 1.73 to 4.12). The most common grade >3 treatment-emergent adverse events in the Isa-Pd cohort were neutrophil count decreased (75.0%, 18/24), white blood cell count decreased (54.2%, 13/24), and anemia (45.8%, 11/24).

Conclusion::

The IsaFiRsT study reported that Isa-Pd provided a high rate of deep and rapid response in heavily pretreated Chinese RRMM patients, with an acceptable safety profile in a real-world setting, consistent with Isa-Pd trials.

Registration::

Chinese Clinical Trial Registry (ChiCTR2200062878).

252

News (Medical) associated with Isatuximab-IRFC

27 Mar 2026

·www.biospace.com

Press Release: Sanofi’s Sarclisa subcutaneous formulation administered via on-body injector recommended for EU approval by the CHMP to treat multiple myeloma

Sanofi’s Sarclisa subcutaneous formulation administered via on-body injector recommended for EU approval by the CHMP to treat multiple myeloma Recommendation based on positive results demonstrating comparable efficacy, pharmacokinetics, and safety of Sarclisa regimens administered subcutaneously compared to intravenous infusion If approved, Sarclisa subcutaneous (SC) would be the first available anticancer treatment to be administered through an on-body injector (OBI), and the first multiple myeloma medicine available by both SC OBI and manual injection in the EU Paris, March 27, 2026. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Sarclisa (isatuximab) subcutaneous (SC) in combination with approved standard-of-care regimens for the treatment of patients with multiple myeloma (MM) across all currently approved indications for Sarclisa intravenous (IV) formulation in the EU. If approved, Sarclisa would be the first available anticancer treatment to be administered through both an on-body injector (OBI) and manual injection, and the only anti-CD38 monoclonal antibody available in MM to offer the flexibility of both an OBI and manual injection. A final decision is expected in the coming months. “This positive CHMP opinion is a pivotal milestone in our mission to improve the treatment experience for multiple myeloma patients and providers,” says Olivier Nataf, Global Head of Oncology at Sanofi. “Our aim is to evolve the treatment experience by combining the clinically proven efficacy of Sarclisa with innovative subcutaneous delivery via an on-body injector. This advancement reflects our unwavering commitment to patients and dedication to transforming care in ways that truly matter to people living with cancer.” The positive CHMP opinion is based on the results from the IRAKLIA phase 3 study in relapsed and/or refractory (R/R) MM (clinical study identifier: NCT05405166 ), which demonstrated non‑inferiority of the SC formulation compared to the IV formulation. Four additional studies supported the decision and include the GMMG-HD8 phase 3 study in transplant-eligible newly diagnosed MM (NDMM, TE) (clinical study identifier: NCT05804032 ), the IZALCO phase 2 study in R/R MM (clinical study identifier: NCT05704049 ), and the ISASOCUT phase 2 study in transplant-ineligible NDMM (NDMM, TI) (clinical study identifier: NCT05889221 ) and one phase 1b study in R/R MM patients who received at least two prior lines of therapy (clinical study identifier: NCT04045795 ). Of the multiple SC studies two studies showed the use of Sarclisa SC + OBI was associated with greater patient satisfaction compared to IV administration, and patient and healthcare provider preference compared to Sarclisa manual injection, based on patient experience and satisfaction questionnaires fielded in the studies. These collective results provide comprehensive evidence supporting the potential use of Sarclisa SC + OBI to advance patient care in NDMM and R/R MM, while maintaining Sarclisa’s strong efficacy and safety profile. The studies were conducted using Enable Injections’ enFuse ® hands-free OBI, an automated injector designed to deliver subcutaneously high-volume medicines beginning with the push of a button, to administer Sarclisa SC formulation. The enFuse device uses a thinner and retractable needle that is smaller compared to the needles commonly used for large-volume injections, which may help support patient comfort. Sarclisa IV is currently approved in four indications in the EU for both NDMM, TI and NDMM, TE, and as early as first relapse in R/R MM. In addition to the EU, a regulatory submission is also under review with the US Food and Drug Administration (FDA). Sarclisa SC + OBI or manual injection is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority. About the IRAKLIA study IRAKLIA (clinical study identifier: NCT05405166 ) was a randomized, open-label, pivotal phase 3 study evaluating the non-inferiority of Sarclisa SC formulation administered at a fixed dose SC via an OBI versus weight-based dosed Sarclisa IV in combination with pomalidomide and dexamethasone (Pd) in adult patients with R/R MM who have received at least one prior line of therapy. The co-primary outcomes assessed were objective response rate (ORR), according to the 2016 International Myeloma Working Group (IMWG) criteria assessed by Independent Review Committee (IRC) and observed Sarclisa concentrations before dosing (C trough) at steady state (pre-dose at cycle 6, day 1 [C6D1]). About the IZALCO study IZALCO (clinical study identifier: NCT05704049 ) was a two-part, randomized, open-label phase 2 study evaluating the efficacy and safety of Sarclisa SC administered via the OBI or by manual injection, in combination with carfilzomib and Kd, for the treatment of adult patients with R/R MM who have received one to three prior lines of therapy. The primary objective is ORR, as assessed by IRC. The key secondary endpoint is patient preference for the Sarclisa SC administered via an OBI versus manual administration of Sarclisa SC. Healthcare provider preference of delivery method is also assessed as exploratory endpoint. About the ISASOCUT study ISASOCOUT (clinical study identifier: NCT05889221 ) is an open-label phase 2 study assessing Sarclisa SC administered via the OBI in combination with bortezomib, lenalidomide and dexamethasone (VRd) in NDMM patients ineligible for autologous stem-cell transplant (ASCT). The primary objective is rate of very good partial response (VGPR) or better, according to the 2016 IMWG criteria assessed by IRC. The study is ongoing. About the GMMG-HD8 study GMMG-HD8 (clinical study identifier: NCT05804032 ) was a randomized, open-label, multicenter phase 3 study evaluating the non-inferiority of Sarclisa SC administered via an OBI versus Sarclisa IV, both in combination with VRd at induction, for the treatment of patients with NDMM eligible for ASCT. The primary endpoint of the study is non-inferiority of SC to IV administration as measured by VGPR or better after induction therapy. Results from an interim analysis were submitted to support the conversion of the indication from Sarclisa IV to Sarclisa SC. About Enable Injections Cincinnati-based Enable Injections is a global healthcare innovation company committed to improving the patient treatment experience through the development and manufacturing of the enFuse® On-Body Delivery System. An innovative wearable technology, the enFuse system is designed to deliver large volumes of pharmaceutical and biologic therapeutics via subcutaneous administration, with the aim of improving convenience, supporting superior outcomes, and advancing healthcare system economics. About Sarclisa Sarclisa (isatuximab) is approved in more than 50 countries, including in the US, EU, Japan, and China, across multiple treatment lines for MM. Based on the ICARIA-MM phase 3 study, Sarclisa is approved in the US, and Japan in combination with Pd for the treatment of patients with R/R MM who have received ≥two prior therapies, including lenalidomide and a proteasome inhibitor. Additionally, Sarclisa is approved in the EU in combination with Pd for the treatment of patients with R/R MM who have received ≥two prior therapies, including lenalidomide and a proteasome inhibitor and have relapsed on the last therapy, and in China for patients who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor. Based on the IKEMA phase 3 study, Sarclisa is also approved in more than 50 countries in combination with Kd, including in the US for the treatment of patients with R/R MM who have received one to three prior lines of therapy and in the EU for patients with MM who have received at least one prior therapy. In the US, EU, and China, Sarclisa is approved in combination with VRd as a front-line treatment option in transplant-ineligible NDMM patients, based on the IMROZ phase 3 study. Sarclisa is also approved in the EU in combination with VRd as an induction treatment for transplant-eligible NDMM patients, based on the GMMG-HD7 phase 3 study. In Japan, Sarclisa is approved in combination with VRd as a front-line treatment option regardless of transplant eligibility. At Sanofi, we are building on a long-standing commitment to oncology as we continue to chase the miracles of science to improve the lives of those living with cancer. We are committed to transforming cancer care by developing innovative, first and best-in-class immunological and targeted therapies for rare and difficult-to-treat cancers with high unmet need. For more information on Sarclisa clinical studies, please visit . About Sanofi Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media Relations Sandrine Guendoul | +33 6 25 09 14 25 | sandrine.guendoul@sanofi.com Evan Berland | +1 215 432 0234 | evan.berland@sanofi.com Léo Le Bourhis | +33 6 75 06 43 81 | leo.lebourhis@sanofi.com Victor Rouault | +1 617 356 4751 | victor.rouault@sanofi.com Timothy Gilbert | +1 516 521 2929 | timothy.gilbert@sanofi.com Léa Ubaldi | +33 6 30 19 66 46 | lea.ubaldi@sanofi.com Ekaterina Pesheva | +1 410 926 6780 | ekaterina.pescheva@sanofi.com Investor Relations Thomas Kudsk Larsen |+ 44 7545 513 693 | thomas.larsen@sanofi.com Alizé Kaisserian | + 33 6 47 04 12 11 | alize.kaisserian@sanofi.com Keita Browne | + 1 781 249 1766 | keita.browne@sanofi.com Nathalie Pham | + 33 7 85 93 30 17 | nathalie.pham@sanofi.com Nina Goworek | +1 908 569 7086 | nina.goworek@sanofi.com Thibaud Châtelet | + 33 6 80 80 89 90 | thibaud.chatelet@sanofi.com Yun Li | +33 6 84 00 90 72 | yun.li3@sanofi.com Sanofi forward-looking statements This press release contains forward-looking statements within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions regarding the marketing and other potential of the product; regarding potential future events and revenues from the product. Words such as “expect,” “anticipate,” “believe,” “intend,” “estimate,” “plan,” “can,” “contemplate,” “could,” “is designed to,” “may,” “might,” “potential,” “objective,” "attempt," “target,” “project,” "strategy," "strive," "desire," “predict,” “forecast,” “ambition,” “guideline,” "seek," “should,” “will,” "goal," or the negative of these and similar expressions are intended to identify forward-looking statements. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks, uncertainties and assumptions include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful; authorities’ decisions regarding whether and when to approve a product candidate; political pressure in the United States to mandate lower drug prices including “most favored nation” pricing for State Medicaid programs; the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues; competition in general; risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the French Markets Authority (AMF) made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2025 or contained in our periodic reports on Form 6-K. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. In light of these risks, uncertainties and assumptions, you should not place undue reliance on any forward-looking statements contained herein. All trademarks mentioned in this press release are the property of the Sanofi group with the exception of enFuse. Attachment Press_Release

Clinical ResultPhase 3Drug ApprovalPhase 2

27 Feb 2026

·www.globenewswire.com

ALX Oncology Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Corporate Update

- Clinical development for both the investigational CD47-inhibitor evorpacept and the novel EGFR-targeted antibody-drug conjugate ALX2004 remains on track following strong 2025 execution; company anticipates multiple meaningful data sets and milestones in the coming 12 to 18 months - - Evorpacept biomarker strategy validated by data from both the Phase 2 ASPEN-06 gastric cancer trial and the Phase 1b/2 breast cancer trial, independently suggesting CD47 overexpression is predictive of evorpacept activity and drives durable benefit in HER2-positive cancers - - Full biomarker analysis from Phase 1b/2 evorpacept-zanidatamab combination trial accepted for poster presentation at ESMO Breast Cancer 2026 Annual Congress - - Phase 2 ASPEN-09 breast cancer trial is currently enrolling patients and will evaluate evorpacept efficacy by CD47 expression levels, with topline data anticipated mid-2027 - - Phase 1 trial evaluating ALX2004 continues to enroll patients in the third dose cohort; safety data from dose-escalation phase expected in 2H 2026 - - Company completed a $150 million registered offering of common stock and pre-funded warrants, extending cash runway through 1H 2028 inclusive of key clinical program milestones for evorpacept and ALX2004 - - Barbara Klencke, M.D., appointed to Chief Medical Officer on a permanent basis - - Company to host webcast on Friday, February 27, at 5:30 a.m. PT / 8:30 a.m. ET - SOUTH SAN FRANCISCO, Calif., Feb. 27, 2026 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc. (“ALX Oncology”; Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, today reported financial results for the fourth quarter and full year 2025, and provided a corporate update. “Through strong execution of our targeted clinical development strategy in 2025, we have positioned ourselves to achieve multiple significant catalysts in the clinical programs for evorpacept and ALX2004, two potentially best- and first-in-class agents, in the coming 12 to 18 months,” said Jason Lettmann, Chief Executive Officer at ALX Oncology. “We are particularly pleased that recent topline biomarker data from the Phase 1b/2 trial evaluating evorpacept with zanidatamab in advanced HER2-positive breast cancer reinforce findings from the ASPEN-06 HER2-positive gastric cancer trial, suggesting that CD47 is a predictive biomarker for evorpacept response. These findings strengthen our confidence in the ongoing Phase 2 ASPEN-09-Breast trial, where we will evaluate patient responses by CD47 level to further define the predictive potential of this biomarker among patients with HER2-positive disease that has progressed following ENHERTU. “Additionally, we are pleased with the clinical progress of ALX2004, which has successfully cleared the first two dose cohorts in the ongoing Phase 1 trial. The potential of these two novel therapies, coupled with our substantial progress on their respective clinical programs, contributed to the successful completion of our recent financing. With our newly strengthened balance sheet, we now have the opportunity to deliver more robust and meaningful data readouts in both of our ongoing clinical programs, as reflected in our milestone updates,” said Lettmann. ALX Oncology Q4 and Full Year 2025 Highlights and Recent Developments Evorpacept Data from a pre-planned exploratory analysis of the Phase 2 ASPEN-06 clinical trial in gastric cancer showed that CD47 overexpression is a key predictive biomarker for evorpacept response and durable benefit in patients whose tumors have retained HER2 expression. Retained HER2 expression is defined as tumors that are HER2-positive following HER2-targeted treatment, as assessed by either a repeat tumor biopsy or HER2 gene amplification in circulating tumor DNA (ctDNA). These data were highlighted as part of a poster presentation at the Society for Immunotherapy of Cancer (SITC) Annual Meeting in November 2025. In patients with retained HER2-positive and CD47-high gastric cancer (n=43), evorpacept + HERCEPTIN® (trastuzumab), CYRAMZA® (ramucirumab) and paclitaxel (TRP) generated a 65.0% objective response rate (ORR) versus 26.1% ORR for TRP alone.The duration of response (DOR) was three times longer in the evorpacept + TRP arm relative to TRP alone in these patients. Evorpacept + TRP generated a median DOR (mDOR) of 25.5 months versus 8.4 months mDOR for TRP alone. Progression-free survival (PFS) and overall survival (OS) data were also evaluated in these patients. Treatment with evorpacept + TRP resulted in a median PFS (mPFS) of 18.4 months versus 7.0 months for TRP alone, with a hazard ratio (HR) of 0.39. Treatment with evorpacept + TRP resulted in a median OS of 17 months versus 9.9 months for TRP alone, with an HR of 0.70. Consistent with the results from the ASPEN-06 trial, topline data from an exploratory analysis in the Phase 1b/2 trial of evorpacept with investigational zanidatamab in advanced HER2-positive breast cancer suggest that CD47 expression level helps predict therapeutic response. Researchers had previously reported primary trial results showing a 56% (5/9) confirmed objective response rate (cORR) and an mPFS of 7.4 months in the nine patients with centrally confirmed HER2-positive breast cancer who received the investigational combination (2024 San Antonio Breast Cancer Symposium).In January 2026, ALX Oncology announced topline data from the exploratory analysis conducted to identify biomarkers of response to the evorpacept/zanidatamab combination. These findings show that among patients with centrally confirmed HER2-positive breast cancer, responses were largely restricted to patients with higher CD47 expression.The full Phase 1b/2 trial biomarker analysis has been accepted for poster presentation at the European Society for Medical Oncology (ESMO) Breast Cancer 2026 Annual Congress on May 7, 2026, in Berlin. The Phase 2 ASPEN-09-Breast trial evaluating evorpacept plus trastuzumab and physician’s choice of chemotherapy in patients with HER2-positive breast cancer previously treated with ENHERTU® (fam-trastuzumab deruxtecan-nxki) began enrollment in January 2026, and site activation remains on track globally. ALX Oncology has updated the primary objective of this trial to assess the overall response rate in patients whose tumors overexpress CD47. The company now plans to expand the number of patients enrolled in ASPEN-09-Breast – from 80 to up to 120 -- to increase the number of patients whose cancer overexpresses this biomarker. The company expects to provide topline data for 80 patients in mid-2027.The Sanofi-partnered, randomized Phase 1/2 UMBRELLA study evaluating evorpacept with SARCLISA® (isatuximab-irfc) and dexamethasone in patients with previously treated multiple myeloma continues to enroll patients in the dose-optimization portion of the trial.Data presented at the American Society of Hematology (ASH) Annual Meeting 2025 from a Phase 2 investigator-sponsored trial (IST) of evorpacept in combination with standard-of-care rituximab and lenalidomide for patients with previously untreated, indolent B-cell non-Hodgkin lymphoma (iNHL) demonstrated a 100% ORR and 92% complete response (CR) rate (with historical control around 50%), and a one-year PFS rate of 91%. While longer follow-up matures, minimal residual disease (MRD) eradication rate with this novel regimen will be evaluated. ALX2004 The Phase 1 trial of ALX2004, a novel antibody-drug conjugate (ADC) for the treatment of epidermal growth factor receptor (EGFR)-expressing solid tumors, began enrolling patients in the third dose cohort at 4mg/kg in January 2026, after no dose-limiting toxicities were observed in the prior two dose cohorts. ALX Oncology plans to share safety data from the dose-escalation phase of this trial in 2H 2026. The ongoing ALX2004 Phase 1 dose-escalation portion of the trial is enrolling patients with previously treated advanced or metastatic non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), esophageal squamous cell carcinoma (ESCC), and colorectal cancer (CRC).ALX2004 preclinical data presented at the World ADC 2026 Conference and at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer demonstrated potent preclinical anti-tumor activity in EGFR-expressing in vivo tumor models across multiple tumor types with differing levels of EGFR expression and varied mutational status across the EGFR signaling pathway. A favorable preclinical safety profile, including no skin toxicity or interstitial lung disease, was observed in pre-clinical toxicology studies at clinically relevant doses of ALX2004. Corporate Update In February 2026, the company completed a registered equity offering, selling 76,979,112 shares of common stock at $1.57 per share and pre-funded warrants to purchase 18,574,120 shares of common stock at $1.569 per underlying share. Gross proceeds from the offering were $150 million. Net proceeds of the offering were $140.4 million, after deducting the underwriting discount and other offering expenses.After serving as Chief Medical Officer in an interim capacity since September 2025, Barbara Klencke, M.D., has been appointed to the position permanently. Dr. Klencke was instrumental in ALX Oncology’s clinical development progress over the past five months. Upcoming Clinical Milestones Phase 1b/2 trial evaluating evorpacept in combination with investigational zanidatamab in advanced HER2-positive breast cancer: Full biomarker analysis to be presented in a poster session on May 7, 2026, at the ESMO Breast Cancer 2026 Annual Congress.Phase 2 ASPEN-09 breast cancer trial: Topline data readout for 80 patients anticipated in mid-2027.Phase 1 ALX2004 trial: Safety data from the dose-escalation phase of trial anticipated in 2H 2026. Fourth Quarter and Full Year 2025 Webcast Information To access the conference call, please dial +1-877-407-0752 or +1-201-389-0912 and ask to be joined into the ALX Oncology Fourth Quarter and Full Year 2025 Financial Results Conference Call. Another option for instant telephone access to the event is to use the Call me™ link below: https://callme.viavid.com/viavid/?callme=true&passcode=13755276&h=true&info=company&r=true&B=6 A live audio webcast of the call, along with accompanying slides, will be available under "Events & Presentations" in the Investor section of the company's website, www.alxoncology.com. An archived webcast will be available on the company's website after the event. Date & Time: Friday, February 27, 2026, 5:30 a.m. PT / 8:30 a.m. ET Webcast Access: https://viavid.webcasts.com/starthere.jsp?ei=1753123&tp_key=d6cfaba210 Fourth Quarter and Full Year 2025 Financial Results Cash, Cash Equivalents and Investments: ALX held $48.3 million in cash, cash equivalents and investments as of December 31, 2025. Along with the $140.4 million in net proceeds from the February 2026 financing, the cash, cash equivalents and investments on hand are expected to be sufficient to fund ALX’s operating expenses through the first half of 2028.Research and Development (“R&D”) Expenses: R&D expenses consist primarily of preclinical, clinical and development costs related to the development of the company’s current product candidates, evorpacept and ALX2004, and R&D personnel-related expenses, including stock-based compensation. R&D expenses for the three months ended December 31, 2025 were $17.6 million compared to $23.5 million for the prior-year period, or a decrease of $5.9 million. This decrease was primarily attributable to a decrease of $2.7 million in stock-based compensation expense, a decrease of $2.5 million in personnel and related costs, and a decrease of $1.5 million in preclinical costs due to pipeline prioritization strategy. These decreases were partially offset by an increase of $0.6 million in clinical and development costs to support active clinical trials for ALX product candidates, evorpacept and ALX2004. R&D expenses for the year ended December 31, 2025, were $77.0 million compared to $116.4 million for the prior-year period.General and Administrative (“G&A”) Expenses: G&A expenses consist primarily of administrative personnel-related expenses, including stock-based compensation and other costs such as legal and other professional fees, patent filing and maintenance fees, and insurance. G&A expenses for the three months ended December 31, 2025 were $5.4 million compared to $7.1 million for the prior year period, or a decrease of $1.7 million. This decrease was primarily attributable to a decrease in stock-based compensation expense and decreases in legal and corporate costs. G&A expenses for the year ended December 31, 2025 were $23.9 million compared to $26.1 million for the prior-year period.Net loss: GAAP net loss was ($22.8) million for the three months ended December 31, 2025, or ($0.42) per basic and diluted share, as compared to a GAAP net loss of ($29.2) million for the three months ended December 31, 2024, or ($0.55) per basic and diluted share. The lower net loss is primarily attributed to lower R&D expenses. GAAP net loss was ($101.7) million for the year ended December 31, 2025, or ($1.90) per basic and diluted share, as compared to a GAAP net loss of ($134.9) million for the year ended December 31, 2024, or ($2.58) per basic and diluted share. Non-GAAP net loss was ($20.1) million for the three months ended December 31, 2025, as compared to a non-GAAP net loss of ($23.2) million for the three months ended December 31, 2024. Non-GAAP net loss was ($88.8) million for the year ended December 31, 2025, as compared to a non-GAAP net loss of ($107.5) million for the year ended December 31, 2024. A reconciliation of GAAP to non-GAAP financial results can be found at the end of this news release. ALX OncologyALX Oncology (Nasdaq: ALXO) is a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives. ALX Oncology’s lead therapeutic candidate, evorpacept, has demonstrated potential to serve as a cornerstone therapy upon which the future of immuno-oncology can be built. Evorpacept is currently being evaluated across multiple ongoing clinical trials in a wide range of cancer indications. ALX Oncology’s second pipeline candidate, ALX2004, is a novel EGFR-targeted antibody-drug conjugate with a differentiated mechanism of action. A Phase 1, dose-escalation trial of ALX2004 is ongoing in patients with EGFR-expressing solid tumors. More information is available at www.alxoncology.com and on LinkedIn @ALX Oncology. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements that involve substantial risks and uncertainties. Forward-looking statements include statements regarding future results of operations and financial position, business strategy, product candidates, planned preclinical studies and clinical trials, results of clinical trials, research and development costs, regulatory approvals, timing and likelihood of success, plans and objectives of management for future operations, as well as statements regarding industry trends. Such forward-looking statements are based on ALX Oncology’s beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause ALX Oncology’s actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These and other risks are described more fully in ALX Oncology’s filings with the Securities and Exchange Commission (“SEC”), including ALX Oncology’s Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other documents ALX Oncology files with the SEC from time to time. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. ALX ONCOLOGY HOLDINGS INC.Consolidated Statements of Operations(unaudited)(in thousands, except share and per share amounts) Three Months Ended Year Ended December 31, December 31, 2025 2024 2025 2024 Operating expenses: Research and development $17,645 $23,532 $76,996 $116,373 General and administrative 5,376 7,081 23,850 26,094 Impairment charge — — 3,175 — Total operating expenses 23,021 30,613 104,021 142,467 Loss from operations (23,021) (30,613) (104,021) (142,467)Interest income 573 1,878 3,964 9,366 Interest expense (383) (427) (1,602) (1,729)Other (expense) income, net (17) (1) (36) (20)Net loss $(22,848) $(29,163) $(101,695) $(134,850)Net loss per share, basic and diluted $(0.42) $(0.55) $(1.90) $(2.58)Weighted-average shares of common stock used to compute net loss per shares, basic and diluted 54,283,507 52,802,409 53,658,399 52,174,904 Consolidated Balance Sheet Data(unaudited)(in thousands) December 31, December 31, 2025 2024 Cash, cash equivalents and investments $48,284 $131,281 Total assets $59,046 $147,775 Total liabilities $33,065 $34,157 Accumulated deficit $(722,817) $(621,122)Total stockholders’ equity $25,981 $113,618 GAAP to Non-GAAP Reconciliation(unaudited)(in thousands) Three Months Ended Year Ended December 31, December 31, 2025 2024 2025 2024 GAAP net loss, as reported $(22,848) $(29,163) $(101,695) $(134,850)Adjustments: Stock-based compensation expense 2,706 5,858 12,579 27,093 Accretion of term loan discount and issuance costs 72 69 280 265 Total adjustments 2,778 5,927 12,859 27,358 Non-GAAP net loss $(20,070) $(23,236) $(88,836) $(107,492) Use of Non-GAAP Financial Measures We supplement our consolidated financial statements presented on a GAAP basis by providing additional measures which may be considered “non-GAAP” financial measures under applicable SEC rules. We believe that the disclosure of these non-GAAP financial measures provides our investors with additional information that reflects the amounts and financial basis upon which our management assesses and operates our business. These non-GAAP financial measures are not in accordance with generally accepted accounting principles and should not be viewed in isolation or as a substitute for reported, or GAAP, net loss, and are not a substitute for, or superior to, measures of financial performance performed in conformity with GAAP. “Non-GAAP net loss” is not based on any standardized methodology prescribed by GAAP and represents GAAP net loss adjusted to exclude stock-based compensation expense and accretion of term loan discount and issuance costs. Non-GAAP financial measures used by ALX Oncology may be calculated differently from, and therefore may not be comparable to, non-GAAP measures used by other companies. Investor Relations Contact: Elhan Webb, CFA, IR Consultantewebb@alxoncology.com Media Contact: Michele Parisi, SparkPoint Healthcare Communicationsmparisi@sparkpointpr.com(925) 864-5028

Clinical ResultPhase 1Phase 2Financial StatementASCO

27 Feb 2026

·ir.alxoncology.com

ALX Oncology Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Corporate Update

- Clinical development for both the investigational CD47-inhibitor evorpacept and the novel EGFR-targeted antibody-drug conjugate ALX2004 remains on track following strong 2025 execution; company anticipates multiple meaningful data sets and milestones in the coming 12 to 18 months - - Evorpacept biomarker strategy validated by data from both the Phase 2 ASPEN-06 gastric cancer trial and the Phase 1b/2 breast cancer trial, independently suggesting CD47 overexpression is predictive of evorpacept activity and drives durable benefit in HER2-positive cancers - - Full biomarker analysis from Phase 1b/2 evorpacept-zanidatamab combination trial accepted for poster presentation at ESMO Breast Cancer 2026 Annual Congress - - Phase 2 ASPEN-09 breast cancer trial is currently enrolling patients and will evaluate evorpacept efficacy by CD47 expression levels, with topline data anticipated mid-2027 - - Phase 1 trial evaluating ALX2004 continues to enroll patients in the third dose cohort; safety data from dose-escalation phase expected in 2H 2026 - - Company completed a $150 million registered offering of common stock and pre-funded warrants, extending cash runway through 1H 2028 inclusive of key clinical program milestones for evorpacept and ALX2004 - - Barbara Klencke, M.D., appointed to Chief Medical Officer on a permanent basis - - Company to host webcast on Friday, February 27, at 5:30 a.m. PT / 8:30 a.m. ET - SOUTH SAN FRANCISCO, Calif., Feb. 27, 2026 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc. ("ALX Oncology"; Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, today reported financial results for the fourth quarter and full year 2025, and provided a corporate update. "Through strong execution of our targeted clinical development strategy in 2025, we have positioned ourselves to achieve multiple significant catalysts in the clinical programs for evorpacept and ALX2004, two potentially best- and first-in-class agents, in the coming 12 to 18 months," said Jason Lettmann, Chief Executive Officer at ALX Oncology. "We are particularly pleased that recent topline biomarker data from the Phase 1b/2 trial evaluating evorpacept with zanidatamab in advanced HER2-positive breast cancer reinforce findings from the ASPEN-06 HER2-positive gastric cancer trial, suggesting that CD47 is a predictive biomarker for evorpacept response. These findings strengthen our confidence in the ongoing Phase 2 ASPEN-09-Breast trial, where we will evaluate patient responses by CD47 level to further define the predictive potential of this biomarker among patients with HER2-positive disease that has progressed following ENHERTU. "Additionally, we are pleased with the clinical progress of ALX2004, which has successfully cleared the first two dose cohorts in the ongoing Phase 1 trial. The potential of these two novel therapies, coupled with our substantial progress on their respective clinical programs, contributed to the successful completion of our recent financing. With our newly strengthened balance sheet, we now have the opportunity to deliver more robust and meaningful data readouts in both of our ongoing clinical programs, as reflected in our milestone updates," said Lettmann. ALX Oncology Q4 and Full Year 2025 Highlights and Recent Developments Evorpacept Data from a pre-planned exploratory analysis of the Phase 2 ASPEN-06 clinical trial in gastric cancer showed that CD47 overexpression is a key predictive biomarker for evorpacept response and durable benefit in patients whose tumors have retained HER2 expression. Retained HER2 expression is defined as tumors that are HER2-positive following HER2-targeted treatment, as assessed by either a repeat tumor biopsy or HER2 gene amplification in circulating tumor DNA (ctDNA). These data were highlighted as part of a poster presentation at the Society for Immunotherapy of Cancer (SITC) Annual Meeting in November 2025. In patients with retained HER2-positive and CD47-high gastric cancer (n=43), evorpacept + HERCEPTIN® (trastuzumab), CYRAMZA® (ramucirumab) and paclitaxel (TRP) generated a 65.0% objective response rate (ORR) versus 26.1% ORR for TRP alone. The duration of response (DOR) was three times longer in the evorpacept + TRP arm relative to TRP alone in these patients. Evorpacept + TRP generated a median DOR (mDOR) of 25.5 months versus 8.4 months mDOR for TRP alone. Progression-free survival (PFS) and overall survival (OS) data were also evaluated in these patients. Treatment with evorpacept + TRP resulted in a median PFS (mPFS) of 18.4 months versus 7.0 months for TRP alone, with a hazard ratio (HR) of 0.39. Treatment with evorpacept + TRP resulted in a median OS of 17 months versus 9.9 months for TRP alone, with an HR of 0.70. In patients with retained HER2-positive and CD47-high gastric cancer (n=43), evorpacept + HERCEPTIN® (trastuzumab), CYRAMZA® (ramucirumab) and paclitaxel (TRP) generated a 65.0% objective response rate (ORR) versus 26.1% ORR for TRP alone. The duration of response (DOR) was three times longer in the evorpacept + TRP arm relative to TRP alone in these patients. Evorpacept + TRP generated a median DOR (mDOR) of 25.5 months versus 8.4 months mDOR for TRP alone. Progression-free survival (PFS) and overall survival (OS) data were also evaluated in these patients. Treatment with evorpacept + TRP resulted in a median PFS (mPFS) of 18.4 months versus 7.0 months for TRP alone, with a hazard ratio (HR) of 0.39. Treatment with evorpacept + TRP resulted in a median OS of 17 months versus 9.9 months for TRP alone, with an HR of 0.70. Consistent with the results from the ASPEN-06 trial, topline data from an exploratory analysis in the Phase 1b/2 trial of evorpacept with investigational zanidatamab in advanced HER2-positive breast cancer suggest that CD47 expression level helps predict therapeutic response. Researchers had previously reported primary trial results showing a 56% (5/9) confirmed objective response rate (cORR) and an mPFS of 7.4 months in the nine patients with centrally confirmed HER2-positive breast cancer who received the investigational combination (2024 San Antonio Breast Cancer Symposium). In January 2026, ALX Oncology announced topline data from the exploratory analysis conducted to identify biomarkers of response to the evorpacept/zanidatamab combination. These findings show that among patients with centrally confirmed HER2-positive breast cancer, responses were largely restricted to patients with higher CD47 expression. The full Phase 1b/2 trial biomarker analysis has been accepted for poster presentation at the European Society for Medical Oncology (ESMO) Breast Cancer 2026 Annual Congress on May 7, 2026, in Berlin. The Phase 2 ASPEN-09-Breast trial evaluating evorpacept plus trastuzumab and physician’s choice of chemotherapy in patients with HER2-positive breast cancer previously treated with ENHERTU® (fam-trastuzumab deruxtecan-nxki) began enrollment in January 2026, and site activation remains on track globally. ALX Oncology has updated the primary objective of this trial to assess the overall response rate in patients whose tumors overexpress CD47. The company now plans to expand the number of patients enrolled in ASPEN-09-Breast – from 80 to up to 120 -- to increase the number of patients whose cancer overexpresses this biomarker. The company expects to provide topline data for 80 patients in mid-2027. The Sanofi-partnered, randomized Phase 1/2 UMBRELLA study evaluating evorpacept with SARCLISA® (isatuximab-irfc) and dexamethasone in patients with previously treated multiple myeloma continues to enroll patients in the dose-optimization portion of the trial. Data presented at the American Society of Hematology (ASH) Annual Meeting 2025 from a Phase 2 investigator-sponsored trial (IST) of evorpacept in combination with standard-of-care rituximab and lenalidomide for patients with previously untreated, indolent B-cell non-Hodgkin lymphoma (iNHL) demonstrated a 100% ORR and 92% complete response (CR) rate (with historical control around 50%), and a one-year PFS rate of 91%. While longer follow-up matures, minimal residual disease (MRD) eradication rate with this novel regimen will be evaluated. Researchers had previously reported primary trial results showing a 56% (5/9) confirmed objective response rate (cORR) and an mPFS of 7.4 months in the nine patients with centrally confirmed HER2-positive breast cancer who received the investigational combination (2024 San Antonio Breast Cancer Symposium). In January 2026, ALX Oncology announced topline data from the exploratory analysis conducted to identify biomarkers of response to the evorpacept/zanidatamab combination. These findings show that among patients with centrally confirmed HER2-positive breast cancer, responses were largely restricted to patients with higher CD47 expression. The full Phase 1b/2 trial biomarker analysis has been accepted for poster presentation at the European Society for Medical Oncology (ESMO) Breast Cancer 2026 Annual Congress on May 7, 2026, in Berlin. ALX2004 The Phase 1 trial of ALX2004, a novel antibody-drug conjugate (ADC) for the treatment of epidermal growth factor receptor (EGFR)-expressing solid tumors, began enrolling patients in the third dose cohort at 4mg/kg in January 2026, after no dose-limiting toxicities were observed in the prior two dose cohorts. ALX Oncology plans to share safety data from the dose-escalation phase of this trial in 2H 2026. The ongoing ALX2004 Phase 1 dose-escalation portion of the trial is enrolling patients with previously treated advanced or metastatic non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), esophageal squamous cell carcinoma (ESCC), and colorectal cancer (CRC). ALX2004 preclinical data presented at the World ADC 2026 Conference and at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer demonstrated potent preclinical anti-tumor activity in EGFR-expressing in vivo tumor models across multiple tumor types with differing levels of EGFR expression and varied mutational status across the EGFR signaling pathway. A favorable preclinical safety profile, including no skin toxicity or interstitial lung disease, was observed in pre-clinical toxicology studies at clinically relevant doses of ALX2004. The ongoing ALX2004 Phase 1 dose-escalation portion of the trial is enrolling patients with previously treated advanced or metastatic non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), esophageal squamous cell carcinoma (ESCC), and colorectal cancer (CRC). ALX2004 preclinical data presented at the World ADC 2026 Conference and at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer demonstrated potent preclinical anti-tumor activity in EGFR-expressing in vivo tumor models across multiple tumor types with differing levels of EGFR expression and varied mutational status across the EGFR signaling pathway. A favorable preclinical safety profile, including no skin toxicity or interstitial lung disease, was observed in pre-clinical toxicology studies at clinically relevant doses of ALX2004. Corporate Update In February 2026, the company completed a registered equity offering, selling 76,979,112 shares of common stock at $1.57 per share and pre-funded warrants to purchase 18,574,120 shares of common stock at $1.569 per underlying share. Gross proceeds from the offering were $150 million. Net proceeds of the offering were $140.4 million, after deducting the underwriting discount and other offering expenses. After serving as Chief Medical Officer in an interim capacity since September 2025, Barbara Klencke, M.D., has been appointed to the position permanently. Dr. Klencke was instrumental in ALX Oncology’s clinical development progress over the past five months. Upcoming Clinical Milestones Phase 1b/2 trial evaluating evorpacept in combination with investigational zanidatamab in advanced HER2-positive breast cancer: Full biomarker analysis to be presented in a poster session on May 7, 2026, at the ESMO Breast Cancer 2026 Annual Congress. Phase 2 ASPEN-09 breast cancer trial: Topline data readout for 80 patients anticipated in mid-2027. Phase 1 ALX2004 trial: Safety data from the dose-escalation phase of trial anticipated in 2H 2026. Fourth Quarter and Full Year 2025 Webcast Information To access the conference call, please dial +1-877-407-0752 or +1-201-389-0912 and ask to be joined into the ALX Oncology Fourth Quarter and Full Year 2025 Financial Results Conference Call. Another option for instant telephone access to the event is to use the Call me™ link below: https://callme.viavid.com/viavid/?callme=true&passcode=13755276&h=true&info=company&r=true&B=6 A live audio webcast of the call, along with accompanying slides, will be available under "Events & Presentations" in the Investor section of the company's website, www.alxoncology.com. An archived webcast will be available on the company's website after the event. Date & Time: Friday, February 27, 2026, 5:30 a.m. PT / 8:30 a.m. ET Webcast Access: https://viavid.webcasts.com/starthere.jsp?ei=1753123&tp_key=d6cfaba210 Fourth Quarter and Full Year 2025 Financial Results Cash, Cash Equivalents and Investments: ALX held $48.3 million in cash, cash equivalents and investments as of December 31, 2025. Along with the $140.4 million in net proceeds from the February 2026 financing, the cash, cash equivalents and investments on hand are expected to be sufficient to fund ALX’s operating expenses through the first half of 2028. Research and Development (“R&D”) Expenses: R&D expenses consist primarily of preclinical, clinical and development costs related to the development of the company’s current product candidates, evorpacept and ALX2004, and R&D personnel-related expenses, including stock-based compensation. R&D expenses for the three months ended December 31, 2025 were $17.6 million compared to $23.5 million for the prior-year period, or a decrease of $5.9 million. This decrease was primarily attributable to a decrease of $2.7 million in stock-based compensation expense, a decrease of $2.5 million in personnel and related costs, and a decrease of $1.5 million in preclinical costs due to pipeline prioritization strategy. These decreases were partially offset by an increase of $0.6 million in clinical and development costs to support active clinical trials for ALX product candidates, evorpacept and ALX2004. R&D expenses for the year ended December 31, 2025, were $77.0 million compared to $116.4 million for the prior-year period. General and Administrative (“G&A”) Expenses: G&A expenses consist primarily of administrative personnel-related expenses, including stock-based compensation and other costs such as legal and other professional fees, patent filing and maintenance fees, and insurance. G&A expenses for the three months ended December 31, 2025 were $5.4 million compared to $7.1 million for the prior year period, or a decrease of $1.7 million. This decrease was primarily attributable to a decrease in stock-based compensation expense and decreases in legal and corporate costs. G&A expenses for the year ended December 31, 2025 were $23.9 million compared to $26.1 million for the prior-year period. Net loss: GAAP net loss was ($22.8) million for the three months ended December 31, 2025, or ($0.42) per basic and diluted share, as compared to a GAAP net loss of ($29.2) million for the three months ended December 31, 2024, or ($0.55) per basic and diluted share. The lower net loss is primarily attributed to lower R&D expenses. GAAP net loss was ($101.7) million for the year ended December 31, 2025, or ($1.90) per basic and diluted share, as compared to a GAAP net loss of ($134.9) million for the year ended December 31, 2024, or ($2.58) per basic and diluted share. Non-GAAP net loss was ($20.1) million for the three months ended December 31, 2025, as compared to a non-GAAP net loss of ($23.2) million for the three months ended December 31, 2024. Non-GAAP net loss was ($88.8) million for the year ended December 31, 2025, as compared to a non-GAAP net loss of ($107.5) million for the year ended December 31, 2024. A reconciliation of GAAP to non-GAAP financial results can be found at the end of this news release. ALX OncologyALX Oncology (Nasdaq: ALXO) is a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives. ALX Oncology’s lead therapeutic candidate, evorpacept, has demonstrated potential to serve as a cornerstone therapy upon which the future of immuno-oncology can be built. Evorpacept is currently being evaluated across multiple ongoing clinical trials in a wide range of cancer indications. ALX Oncology’s second pipeline candidate, ALX2004, is a novel EGFR-targeted antibody-drug conjugate with a differentiated mechanism of action. A Phase 1, dose-escalation trial of ALX2004 is ongoing in patients with EGFR-expressing solid tumors. More information is available at www.alxoncology.com and on LinkedIn @ALX Oncology. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements that involve substantial risks and uncertainties. Forward-looking statements include statements regarding future results of operations and financial position, business strategy, product candidates, planned preclinical studies and clinical trials, results of clinical trials, research and development costs, regulatory approvals, timing and likelihood of success, plans and objectives of management for future operations, as well as statements regarding industry trends. Such forward-looking statements are based on ALX Oncology’s beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause ALX Oncology’s actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These and other risks are described more fully in ALX Oncology’s filings with the Securities and Exchange Commission ("SEC"), including ALX Oncology’s Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other documents ALX Oncology files with the SEC from time to time. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Use of Non-GAAP Financial Measures We supplement our consolidated financial statements presented on a GAAP basis by providing additional measures which may be considered "non-GAAP" financial measures under applicable SEC rules. We believe that the disclosure of these non-GAAP financial measures provides our investors with additional information that reflects the amounts and financial basis upon which our management assesses and operates our business. These non-GAAP financial measures are not in accordance with generally accepted accounting principles and should not be viewed in isolation or as a substitute for reported, or GAAP, net loss, and are not a substitute for, or superior to, measures of financial performance performed in conformity with GAAP. "Non-GAAP net loss" is not based on any standardized methodology prescribed by GAAP and represents GAAP net loss adjusted to exclude stock-based compensation expense and accretion of term loan discount and issuance costs. Non-GAAP financial measures used by ALX Oncology may be calculated differently from, and therefore may not be comparable to, non-GAAP measures used by other companies. Investor Relations Contact: Elhan Webb, CFA, IR Consultantewebb@alxoncology.com Media Contact: Michele Parisi, SparkPoint Healthcare Communicationsmparisi@sparkpointpr.com(925) 864-5028

Clinical ResultPhase 1Phase 2AACRASCO

100 Deals associated with Isatuximab-IRFC

External Link

KEGG	Wiki	ATC	Drug Bank
-	Isatuximab-IRFC	L01	DB14811

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Relapse multiple myeloma	Japan	Sanofi KK	29 Jun 2020
Multiple Myeloma	United States	Sanofi-Aventis U.S. LLC	02 Mar 2020

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Recurrent Multiple Myeloma	Phase 3	United States	Sanofi-Aventis Recherche & Développement SA	10 Nov 2022
Recurrent Multiple Myeloma	Phase 3	China	Sanofi-Aventis Recherche & Développement SA	10 Nov 2022
Recurrent Multiple Myeloma	Phase 3	Japan	Sanofi-Aventis Recherche & Développement SA	10 Nov 2022
Recurrent Multiple Myeloma	Phase 3	Argentina	Sanofi-Aventis Recherche & Développement SA	10 Nov 2022
Recurrent Multiple Myeloma	Phase 3	Australia	Sanofi-Aventis Recherche & Développement SA	10 Nov 2022
Recurrent Multiple Myeloma	Phase 3	Brazil	Sanofi-Aventis Recherche & Développement SA	10 Nov 2022
Recurrent Multiple Myeloma	Phase 3	Canada	Sanofi-Aventis Recherche & Développement SA	10 Nov 2022
Recurrent Multiple Myeloma	Phase 3	Chile	Sanofi-Aventis Recherche & Développement SA	10 Nov 2022
Recurrent Multiple Myeloma	Phase 3	Czechia	Sanofi-Aventis Recherche & Développement SA	10 Nov 2022
Recurrent Multiple Myeloma	Phase 3	France	Sanofi-Aventis Recherche & Développement SA	10 Nov 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05147493 (ASH2025)	Phase 2	anti-CD38 monoclonal antibody	51	Isatuximab + Lenalidomide (maintenance)bortezomib + cyclophosphamide + dexamethasone (induction) + Isatuximab + Lenalidomide (maintenance)bortezomibde cyclophosphamide	lcomzsxnrb(qrckbcsijn) = vswokfwrvw rdaokmvpwt (wkjakvvour ) View more	Positive	06 Dec 2025
NCT05298683 (ASH2025)	Phase 2	Relapse multiple myeloma	56	Isatuximab+Pomalidomide+Dexamethasone (non-randomized)	oewqthjizl(efnytgjhhu) = ufzkczixhk vseadnntcv (fotseujuat ) View more	Positive	06 Dec 2025
				Isatuximab+Pomalidomide+Dexamethasone (Q2W-randomized)	oewqthjizl(efnytgjhhu) = gdzlxobzot vseadnntcv (fotseujuat ) View more
NCT04751877 (IFM 2020-05, ASH2025)	Phase 3	Multiple Myeloma First line	269	Isatuximab+Lenalidomide+Dexamethasone+Bortezomib	nzzcjxlipd(gczoqumoro): OR = 2.26 (95.0% CI, 1.35 - 3.79), P-Value = 0.002 View more	Positive	06 Dec 2025
				Isatuximab+Lenalidomide+Dexamethasone
isasocut (ASH2025)	Phase 2	Multiple Myeloma First line	74	Isatuximab+ bortezomib +lenalidomide +dexamethasone	exsfzplwcx(bmkacenotp) = ayjcmsmbfu pweglfskjh (wfaakyasik ) View more	Positive	06 Dec 2025
NCT03275285 (IKEMA, ASH2025)	Phase 3	Relapse multiple myeloma M-protein	89	Isatuximab + Carfilzomib + Dexamethasone	wfiitegpqk(hagofvjjfb) = iixbliyrar njliywwjov (cgacluhodn ) View more	Positive	06 Dec 2025
RADAR (ASH2025)	Phase 2/3	-	70	Isa-VRDc (double-hit ultra-high risk myeloma)	mkezijsfdk(uqtyxvkuvp) = tqecdqhpcx fjipykuowj (kpmdnyhwzs ) View more	Positive	06 Dec 2025
NCT03319667 (IMROZ, ASH2025)	Phase 3	Multiple Myeloma	336	Isatuximab + bortezomib + lenalidomide + dexamethasone	ysgjhyysgw(wbsszyfgqr) = luoqaafezf kvlxdkmwmp (viupeddfjj )	Positive	06 Dec 2025
				Isatuximab + bortezomib + lenalidomide + dexamethasone (≤75 years)	bopujswmmi(yldfjhzgns) = qlyjfmclxm gfgwjcoalc (ypgoaysuve ) View more
ASH2025	Not Applicable	Multiple Myeloma	6,301	subsequent treatment (Patients aged <70)	pmgpxnydsp(rqctgmpdft) = zkyeiljgvi jqaveopebb (smuqnynpie ) View more	Negative	06 Dec 2025
				subsequent treatment (Patients aged ≥70)	pmgpxnydsp(rqctgmpdft) = wfxsdgjcvf jqaveopebb (smuqnynpie ) View more
NCT03617731 (GMMG-HD7, ASH2025)	Phase 3	Multiple Myeloma	662	Isa-RVd	rgrmkzgwyr(aqrqrjubrj) = twmzgnfjog vclisvqgot (lyflqeirqg ) View more	Positive	06 Dec 2025
				RVd	rgrmkzgwyr(aqrqrjubrj) = pymaumeagy vclisvqgot (lyflqeirqg ) View more
ACTRN12621001037897 (IBIS, ASH2025)	Phase 1	Multiple Myeloma	29	Iberdomide+Isatuximab+Dexamethasone	jcaiptzwfa(smktgafjzo) = gqxtteqvtd umqouxmqvu (ftbdlowarq, 50.3 - 82.6) View more	Positive	06 Dec 2025

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