Robust clinical data validating CD47 biomarker
Multiple independent datasets (gastric, breast, NHL) demonstrate CD47 as a predictive biomarker for evorpocept (EVO). In HER2-positive gastric cancer CD47-high subgroup, response rate was 65% vs 26% control (delta ~39%), median PFS 18.4 vs 7.0 months (HR 0.39), median OS 17 vs ~10 months (HR 0.7), and median duration of response >2 years (>3x control). In a small HER2-positive breast combo cohort (n=9 confirmed HER2), response rate was 56% with median PFS 7.4 months; responders were predominantly CD47 overexpressors.
Strong activity in hematologic malignancies
In treatment‑naive, first‑line indolent non‑Hodgkin’s lymphoma patients treated with EVO + R‑squared, complete response (CR) rate reached 92%, described as almost double the CR rate seen with R‑squared alone, supporting broad potential of EVO in heme malignancies when combined with Fc‑active antibodies.
ALX 2004 (EGFR ADC) progressing through dose escalation
ALX 2004 cleared the first two dose cohorts and is dosing at 4 mg/kg in phase 1 (dose escalation + expansion). Preclinical data show potent, dose‑dependent antitumor activity across EGFR expression levels and relevant mutations, with no EGFR‑related skin toxicity or interstitial lung disease seen in GLP nonhuman primate tox studies. Full dose‑escalation safety data expected in 2H 2026.
Large financing strengthens balance sheet and runway
Completed an equity financing with gross proceeds of $150,000,000 and net proceeds of $140,400,000. Company had $48.3M cash & investments at 12/31/2025 pre‑financing and states the post‑financing cash position is sufficient to fund operations through 2028, enabling delivery of multiple near‑term data readouts.
Operational focus and clear near‑term milestones
Management prioritizing execution on two lead programs (EVO and ALX 2004). Key guided milestones: full biomarker analysis from the danitatumab combo at ESMO Breast (May 2026), ALX 2004 dose‑escalation safety data (2026), and top‑line ASPEN breast data from 80 patients (mid‑2027).
Reduced quarterly GAAP net loss year‑over‑year
GAAP net loss for the quarter was $22.8M ($0.42 per share) vs $29.2M ($0.55) year‑ago — a decrease of approximately 22% in dollars and ~24% on a per‑share basis, attributed to lower stock compensation, personnel costs, and reduced preclinical spending after pipeline prioritization.
Expansion and biomarker‑driven refinement of ASPEN‑9
Phase 2 ASPEN‑9 breast trial upsized from 80 to up to 120 patients and primary endpoint updated to response rate in CD47‑high patients to increase power for selecting a predictive CD47 cut point; top‑line readout for 80 patients still guided to mid‑2027.