CUE — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-14

• We are a clinical-stage therapeutics company focused on advancing a portfolio of potentially transformative therapies aimed at enabling functional cures across immunological disorders. Our lead asset, CUE-221, is a novel humanized anti-IgE monoclonal antibody with a dual-mechanism of action currentl…

• On April 30, 2026, we entered into an exclusive license agreement with Ascendant Health Sciences Ltd., or Ascendant Health, to develop, manufacture and commercialize CUE-221. IgE-mediated allergic diseases remain an area of significant unmet medical need, as many patients continue to experience pers…

• CUE-221, is a humanized anti-IgE IgG1 monoclonal antibody that binds in a differentiated way to IgE leading to a distinct IgE conformation. CUE-221 has a dual mechanism of action; it neutralizes free IgE with picomolar potency and leverages the naturally occurring CD23-mediated IgE downregulation pa…

• Under Ascendant Health, the program completed a Phase 1 single-ascending dose clinical trial. Pre-clinical experiments and results from the Phase 1 clinical trial were published in the Journal of Clinical Investigation in 2022. In a Phase 1 single ascending dose trial, CUE-221 demonstrated a favorab…

• We are expecting to submit an Investigational New Drug, or IND, amendment to the U.S. Food and Drug Administration, or FDA, to expand development into food allergy in the second half of 2026. CUE-221 is currently being evaluated in a Phase 2 clinical trial in chronic spontaneous urticaria, or CSU, b…

Text removed vs the prior filing · source: 10-Q · 2025-11-12

• 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 disease and cancer. Unlike conventional approaches that broadly activate the immune system, our…

• CUE-400 series (Autoimmune Diseases): Exploit transforming growth factor beta (TGF-β) and Interleukin 2 (IL2) 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…

• 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. Ltd. for development in oncology indications).

• We aim to leverage our differentiated platform to establish new standards of care, forge strategic partnerships, and accelerate clinical development.

Text added vs the prior filing · source: 10-Q · 2026-05-14

• We may derive results and data for CUE-221 from clinical trials conducted by Ascendant in China. Our access to the clinical results and data, or our access to clinical trial support services or clinical supply, may be limited and there is no assurance that the clinical data from any such trials will…

• Ascendant is developing CUE-221 in a clinical trial in China in chronic spontaneous urticaria. While this trial may provide us with clinical data that can inform our future development strategy, we do not have control over the protocols, administration, or conduct of the trial or its compliance with…

• In connection with the development of CUE-221 or any of our other product candidates, we may rely upon one or more companies located in China, or that are owned or operated by Chinese companies, to provide non-clinical or clinical trial support services or clinical supply. If so, the process of chan…

• If we fail to comply with our obligations in the agreements under which we license development or commercialization rights to products or technology from third parties, we could lose license rights that are important to our business.

• We hold an exclusive license from Einstein to intellectual property relating to certain patent rights, relating to our core technology platform for the engineering of biologics to control T cell activity, precision, immune-modulatory drug product candidates, and two supporting technologies that enab…

Text removed vs the prior filing · source: 10-Q · 2025-11-12

• Our recurring losses from operations raise substantial doubt regarding our ability to continue as a going concern.

• We have incurred significant losses since our inception and have never generated revenue or profit from product sales, and it is possible we will never generate revenue or profit from product sales. As of September 30, 2025, we had cash, cash equivalents and marketable securities of $18.7 million. B…

• Moreover, these factors raise substantial doubt about our ability to continue as a going concern. Substantial doubt about our ability to continue as a going concern may materially and adversely affect the price per share of our common stock, and it may be more difficult for us to obtain financing. I…

• Changes in and uncertainty surrounding U.S. trade policy could have a material adverse impact on our business, financial condition and results of operations.

• This past spring, the Trump Administration initiated a series of tariff-related actions against U.S. trading partners. On April 2, 2025, the President issued an Executive Order announcing a “baseline” reciprocal tariff of 10% on all U.S. trading partners effective April 5, 2025, and higher individua…

Text removed vs the prior filing · source: 10-Q · 2025-11-12

• Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing

• On May 12, 2025, we received a deficiency letter, or the Notice, from the Listing Qualifications Department, or the Staff, of Nasdaq indicating that we failed to comply with the Nasdaq continued listing requirement to maintain a minimum closing bid price of at least $1.00 per share, or the Minimum B…

• Thereafter, on November 11, 2025, we received a written notice from the Staff granting us an additional 180 calendar day compliance period (until May 11, 2026), or the Second Compliance Period, to regain compliance with the Minimum Bid Requirement.

• We intend to actively monitor the closing bid price of our common stock and will evaluate available options to regain compliance with the Minimum Bid Requirement. If at any time during the Second Compliance Period the closing bid price of our common stock is at least $1.00 per share for a minimum of…