ADDED
As of March 13, 2026, the registrant had 97,660,791 shares of Common Stock, $0.001 par value per share, outstanding.
We are substantially dependent on the success of our drug product candidates, and significant additional research and development and clinical testing will be required before we can potentially seek regulatory approval for or commercialize any of our drug product candidates.
Business Overview We are a clinical-stage biopharmaceutical company developing a novel class of injectable therapeutics engineered to selectively engage and modulate disease-specific T cells for the treatment of autoimmune and inflammatory diseases.
We believe our Immuno-STAT platform holds the promise of producing drug product candidates with the potential of establishing new standards of care in the treatment of autoimmune and inflammatory diseases.
Our programs include, but are not limited to, drug product candidates designed to: CUE-400 series (Autoimmune Diseases): Exploit transforming growth factor beta (TGF- ) and Interleukin 2 (IL-2) signaling to induce an anti-inflammatory process, with a novel and unique mechanism to not only foster proliferation of regulatory T cells (Tregs) but also induce Tregs from T effector cells with the potential of restoring immune balance and functional immune tolerance (e.g., CUE-401 for autoimmune conditions).
CUE-500 series (Targeted Cell Depletion): Redirect anti-viral killer T cells to target and eliminate defined pathogenic cells (e.g., CUE-501 for autoimmune B cell depletion, which has been licensed to Boehringer Ingelheim International GmbH).
CUE-100 series (Oncology): Selectively activate and expand tumor-specific T cells (e.g., CUE-101 for HPV+ cancers and CUE-102 for Wilms tumor 1 protein (WT1), expressing cancers, both of which have been licensed to ImmunoScape Pte.
As represented in the following image, the Immuno-STAT framework is engineered to be highly flexible and modular, potentially enabling us to deploy the same or similar core functional elements to restore immune balance across diverse therapeutic approaches.
Immuno-STAT Platform Pipeline of Assets for Restoration of Immune Balance 4 CUE-401 In autoimmune disease, Tregs are the master regulators of maintaining immune homeostasis, or balance, and health.
Autoreactive T cells, referred to as T effector cells (Teff cells), are reactive against self proteins and foster inflammation and induce chronic tissue damage.
REMOVED
As of March 27, 2025, the registrant had 61,819,101 shares of Common Stock, $0.001 par value per share, outstanding.
We are substantially dependent on the success of our drug product candidates, only two of which are currently being tested in clinical trials, and significant additional research and development and clinical testing will be required before we can potentially seek regulatory approval for or commercialize any of our drug product candidates.
We have a loan agreement that requires us to meet certain operating covenants and place restrictions on our operating and financial flexibility.
Business Executive Summary We are a clinical-stage biopharmaceutical company developing precision immunotherapies to treat cancer and autoimmune diseases.
Our lead programs include drug product candidates designed to: CUE-400 series (Autoimmune Diseases): Enhance regulatory T cells (Tregs) with a novel and unique mechanism to not only proliferate but also generate Tregs, and restore immune balance (e.g., CUE-401 for autoimmune condition).
CUE-500 series (Targeted Cell Depletion): Redirect antiviral T cells to target eliminate pathogenic cells (e.g., CUE-501 for autoimmune B cell depletion).
CUE-100 series (Oncology): Selectively activate tumor-specific T cells (e.g., CUE-101 for HPV+ cancers, CUE-102 for WT-1 expressing cancers).
Overview We are developing a novel class of injectable therapeutics engineered to selectively engage and modulate targeted, disease-relevant T cells.
Through our approach, we aim to establish a new standard of care for diseases that cause human suffering and mortality, with an initial focus on cancer and autoimmune disease, by selectively modulating the immune system to restore function and re-establish immune balance.
We believe our proprietary Immuno-STAT (Selective Targeting and Alteration of T Cells) platform, as described below, will enable us to therapeutically enhance a patient s own immune system to potentially restore health.