Aptevo Therapeutics

Clinical progress, pipeline expansion, and operational momentum underpin leadership continuity as the Company advances into 2026 and beyond

Together with cash on hand, the fully leveraged facility extends Aptevo's funding runway into 2029, enabling achievement of key clinical and preclinical milestones

100% of patients in Cohorts 1-3 remain free of cytokine release syndrome

CRIS-7-derived CD3 design underpins a controlled T-cell response, supporting the differentiated safety profile, combinability with standard of care

First data on Aptevo's new molecule presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting

89% of evaluable mipletamig patients achieve remission in combination therapy for frontline AML across two trials

Introduces first trispecific molecules, APVO451 and APVO452, advancing therapies designed to overcome immune suppression in certain solid tumors

Both molecules leverage Aptevo's unique use of the CRIS-7-derived CD3 binding domain, associated with favorable safety outcomes in the clinic; CD3 T-cell engager portfolio expanded to five

Company raises $18.7 million in the third quarter, $4.1 million since quarter end, extends cash runway into 4Q26

No dose-limiting toxicities or cytokine release syndrome observed in RAINIER to date; mipletamig shows consistently favorable safety and tolerability

Trial progressing efficiently, Cohort 4 open for enrollment

New candidates, APVO452 and APVO451, harness proprietary ADAPTIR-FLEX^TM design to target prostate and multiple solid tumor cancers by simultaneously engaging tumor antigens, T cells, and immunosuppressive cells

Mipletamig-driven clinical validation of the CRIS-7-derived CD3 binding domain underpins Aptevo's introduction of new, trispecific CD3-directed anti-cancer molecules

Builds on the targeted immune activation model validated by mipletamig in AML, adapted for prostate cancer.

Engineered for precision T-cell activation in prostate cancer; part of Aptevo's growing CRIS-7-derived CD3 portfolio targeting both hematologic and solid tumors

Mipletamig's 85% frontline AML remission rate and favorable safety profile drive APVO's differentiated CD3 portfolio expansion with APVO455, a Nectin-4 x CD3 bispecific for multiple solid tumor types

CD3 bispecific portfolio now includes three candidates - mipletamig (AML), APVO442 (prostate cancer), and newly added APVO455 - advancing a targeted, tumor-specific strategy uniquely engineered for safety, tumor specificity and clinical impact

Mipletamig, continues to outperform benchmarks, trial enrollment continues

$15.9 million raised in 2Q25, extending cash runway into late 4Q25

Mipletamig-driven clinical validation of the CRIS-7 derived CD3-binding domain underpins Aptevo's expansion from hematologic to solid tumors

New candidate APVO455 targets Nectin-4+ cancers, joins mipletamig (AML) and APVO442 (prostate) in Aptevo's tumor-directed CD3 suite

85% remission rate observed in evaluable frontline AML patients

Mipletamig combination enables rare pathway to transplant in a previously ineligible unfit patient

No dose-limiting toxicities observed among evaluable patients; safety profile remains strong

Evidence mounts for mipletamig as a potentially transformational addition to standard of care in frontline AML as targeted CD123 x CD3 approach showing power and precision, limited added toxicity

Mipletamig Trial Momentum Builds as Cohort 3 Nears Full Enrollment at highest dose level evaluated to date in combination therapy

9 of 10 frontline AML patients achieve remission with mipletamig + standard of care across two trials

Mipletamig triplet combination continues to outperform standard doublet benchmark

No cytokine release syndrome observed in the ongoing RAINIER trial: favorable safety profile supports role in frontline AML

Cohort 2 enrollment is complete, and Cohort 3 is now enrolling

As lead candidate mipletamig continues to outperform efficacy and safety benchmarks in AML trials, APVO711 exemplifies emerging innovation from Aptevo's proprietary ADAPTIR® platform

In preclinical studies, APVO711 demonstrates dual anti-cancer functionality with broad solid tumor potential and developability

Continues focus on development of bispecific anti-cancer agents with differentiated mechanisms of action

100% of Patients Achieved Remission Within 30 Days in Cohort 1 of the Mipletamig RAINIER Dose Optimization Trial for Frontline AML Patients, Trial Enrollment Continues

Promising Data, including a 59% Stable Disease Rate, in ALG.APV-527 Phase 1 Trial for the Treatment of Multiple Solid Tumors Makes the Case for Continued Development of First-in-Class Anti-Cancer Agent

Also giving an in-session talk titled "Modular Multispecific Biotherapeutics: Rapid Therapeutic Design with the ADAPTIR^® Platform," showcasing Aptevo's drug engineering and rational drug design expertise

Two of three patients achieved both complete remission and MRD-negative status

High response rates observed in earlier studies continue in ongoing mipletamig trial

Cohort 2 enrollment commencing

Powered by Aptevo's proprietary ADAPTIR-FLEX^®platform, antibody innovation targeting difficult-to-treat cancers

Aptevo's Peter Pavlik, PhD, to chair a session on "Bi and Multispecific Biologics" and will also give talk titled "Modular Multispecific Biotherapeutics: Rapid Therapeutic Design with the ADAPTIR™ Platform" at Cambridge Healthcare Institute's, Pep Talk 2025

Developing innovative bispecific antibodies for monotherapy and combination with the potential to expand the frontiers of cancer treatment

Aptevo Therapeutics and Alligator Bioscience report favorable safety, tolerability and evidence of biological activity of ALG.APV-527, more than half of evaluable patients achieved stable disease

Colon cancer patient achieved stable disease and remained on study for more than six months, breast cancer patient remained on study for more than 11 months

Biomarker analysis confirms immune activation in the tumor microenvironment

Data Presented at Society for Immunotherapy of Cancer on November 8, 2024

Early Data Indicate Clinical Activity in Patients with Multiple Solid Tumor Types

Prolonged stable disease lasting >11 months demonstrated in Breast Cancer Patient

Favorable Pharmacokinetics, Safety and Tolerability Observed

Data Presented at the European Society of Medical Oncology on September 14, 2024