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federal government shutdowns, economic downturns, bank failures or instability in the financial services sector, or geopolitical risks, disasters, and medical or public health crises, such as the COVID-19 pandemic; our plans for and prospects of our acquisitions and other business development activities, and our ability to successfully capitalize on these opportunities; changes in our financial and internal controls; and our anticipated use of our existing cash and cash equivalents, short-term and long-term investments, and the funds available from our term loan.
BUSINESS Overview We are a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients lives.
Our clinical pipeline includes two clinical-stage product candidates, the CD47 blocker evorpacept and an epidermal growth factor receptor (EGFR)-targeted antibody drug candidate (ADC) ALX2004.
Our lead product candidate, evorpacept, has demonstrated potential to serve as a cornerstone therapy upon which the future of immuno-oncology can be built for patients whose cancer over-expresses CD47.
Evorpacept is currently being evaluated in combination with trastuzumab and chemotherapy in patients with metastatic HER2-positive breast cancer in the Phase 2 ASPEN-09-Breast clinical trial and is also being studied in clinical trials with other targeted anti-cancer antibodies.
Cancer cells leverage CD47, a cell surface protein, as a don t eat me signal to evade macrophage phagocytosis.
Our second pipeline candidate, ALX2004, is a novel EGFR-targeted antibody-drug conjugate with a differentiated mechanism of action entered into a Phase 1 clinical trial in August 2025.
The CD47 binding domain of evorpacept is an affinity enhanced extracellular domain of SIRP , a protein found on myeloid cells such as macrophages, that is the natural receptor to CD47.
We believe evorpacept has a favorable tolerability profile that may enable higher dosing levels, increased tumor penetration, and greater combination potential with other leading anti-cancer agents.
Approximately 800 subjects have been treated with evorpacept in combination with targeted anti-cancer agents, small molecules, and checkpoint inhibitors to date.
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BUSINESS Overview We are a clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 immune checkpoint and bridge the innate and adaptive immune system.
Our lead product candidate, the CD47 blocker evorpacept, is currently in multiple Phase 1 and 2 clinical trials.
Cancer cells leverage CD47, a cell surface protein, as a don t eat me signal to evade macrophage phagocytosis or as a don t activate T-cells signal that prevents activation of T-cells by dendritic cells.
The CD47 binding domain of evorpacept is an affinity enhanced extracellular domain of SIRP , a protein that is the natural receptor to CD47 found on myeloid cells.
We believe evorpacept has a favorable tolerability profile that may enable higher dosing levels and greater combination potential with other leading anti-cancer agents.
Over 700 subjects have been treated with evorpacept in combination with targeted anti-cancer agents, small molecules, and checkpoint inhibitors to date.
We are focused on evorpacept development with the standard-of-care agents, revolving around these two cell types: macrophages and dendritic cells.
We initially pursued, and continue to pursue, development of evorpacept based on two well-validated mechanisms of action involving SIRP alpha expression on macrophages and dendritic cells as discussed below.
1 The distinct mechanism of actions and examples of the combinations of priority are: (1) Anti-cancer antibodies (the don t eat me signal) : Combining with anti-cancer targeted antibodies with an active Fc domain, where evorpacept enables the Fc-mediated antibody dependent phagocytosis that is impaired by the expression of CD47 on cancer cells .
Results from the December 2024 data cutoff were presented at an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium: o Primary endpoints (December 2024 data cutoff): Intent-to-treat (ITT) patient population overall response rate (ORR) (n=127): Evo-TRP demonstrated an ORR of 41.3% compared to 30% for ramucirumab and paclitaxel (RP) historical control and 26.6% for TRP control.