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Cue Biopharma to Present New Preclinical Data on Lead Autoimmune and Inflammatory Disease Candidate CUE-401 at IMMUNOLOGY2026

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Cue Biopharma (Nasdaq: CUE) will present new preclinical data on lead candidate CUE-401 at IMMUNOLOGY2026 in Boston, April 15-19, 2026. The poster describes a bifunctional TGF-beta/IL-2 fusion that promotes antigen-specific FOXP3+ iTreg expansion, supporting potential to restore immune homeostasis.

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Positive

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Negative

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News Market Reaction – CUE

+65.37% 3.1x vol
80 alerts
+65.37% Session close to close
+97.6% Peak Tracked
-2.7% Trough Tracked
$80.07M Market Cap
3.1x Rel. Volume

In the Apr 15 session, CUE gained 65.37%, reflecting a significant positive market reaction. Argus tracked a peak move of +97.6% during that session. Argus tracked a trough of -2.7% from its starting point during tracking. Our momentum scanner triggered 80 alerts that day, indicating high trading interest and price volatility. Trading volume was very high at 3.1x the daily average, suggesting strong buying interest.

Data tracked by StockTitan Argus on the day of publication.

Market Context

The stock surged +65.4% in the session following this news. A strong positive reaction aligns with t...
Analysis

The stock surged +65.4% in the session following this news. A strong positive reaction aligns with the company’s pattern of outsized moves on CUE-401 updates, such as the prior +45.48% response to a collaboration milestone. Investors have also seen recent financing flexibility via a $300,000,000 shelf and ATM capacity. However, a history of losses and prior post-earnings declines suggest that funding decisions or dilution, as well as sentiment around early-stage data, could influence how durable any enthusiasm for this preclinical update proves to be.

Key Figures

Preclinical milestone: $7.5M Future milestones: $337.5M Q4 2025 collaboration revenue: $21.9M +5 more
8 metrics
Preclinical milestone $7.5M Milestone payment from Boehringer Ingelheim collaboration expected May 2026
Future milestones $337.5M Potential additional milestone payments under Boehringer Ingelheim collaboration
Q4 2025 collaboration revenue $21.9M Reported in Q4 2025 results released Mar 16, 2026
Year-end 2025 cash $27.1M Cash and equivalents at end of 2025
2025 net loss $26.6M Full-year 2025 net loss
Public offering proceeds $10.2M Net proceeds from public offering noted in 2025 results
Shelf registration size $300,000,000 Total securities registered under S-3 shelf filed Mar 17, 2026
ATM capacity $12,666,282 Maximum common stock to be sold via Jefferies ATM under S-3

Historical Context

5 past events · Latest: Apr 08 (Positive)
Pattern 5 events
Date Event Sentiment 24h Move Catalyst
Apr 08 Collaboration milestone Positive +45.5% $7.5M preclinical milestone from Boehringer Ingelheim collaboration and license.
Mar 27 CEO transition Neutral -5.6% Interim CEO appointment and leadership change focused on advancing CUE-401.
Mar 26 R&D day announcement Neutral -5.0% Announcement of virtual R&D Day to discuss CUE-401 research.
Mar 16 Earnings and updates Negative -12.8% Q4 and 2025 results with collaboration revenue, cash balance, loss, and financing.
Mar 09 Scientific meeting data Positive +0.4% New in vitro CUE-401 data presented at WIRM 2026 on immune modulation.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

News on partnerships and scientific data for CUE-401 often led to positive or modest moves, while corporate and financial updates have more frequently coincided with downside pressure.

Recent Company History

Over recent months, Cue Biopharma has highlighted multiple developments around lead autoimmune candidate CUE-401 and strategic collaborations. A $7.5M preclinical milestone tied to Boehringer Ingelheim on Apr 8, 2026 was followed by a strong +45.48% move. Earlier in March, announcements on a virtual R&D day, new in vitro data at WIRM 2026, and 2025 earnings with financing actions saw share price declines between -5.03% and -12.84%. A CEO transition on Mar 27, 2026 also coincided with a negative reaction, underscoring sensitivity to leadership and funding signals.

Key Terms

tgf-beta, il-2, foxp3+ tregs, t regulatory cells, +2 more
6 terms
tgf-beta medical
"A Novel Bifunctional TGF-beta/IL-2 Fusion Protein that Induces Selective Expansion..."
Transforming growth factor-beta (TGF-β) is a naturally occurring signaling protein that cells use to communicate instructions about growth, repair, and immune activity; think of it as a traffic controller for tissue behavior. It matters to investors because abnormal TGF-β signaling is linked to cancer, fibrosis and immune diseases, making it a common drug target and potential biomarker—so changes in research, approvals or trial results around TGF-β can strongly affect company valuations.
il-2 medical
"A Novel Bifunctional TGF-beta/IL-2 Fusion Protein that Induces Selective Expansion..."
Interleukin-2 (IL-2) is a small protein the body uses as a messenger to tell immune cells when to grow and act, like a coach sending signals to players on a team. For investors, IL-2 matters because drugs that boost, mimic, or block its activity can change how well immune therapies work and what side effects they cause, affecting clinical trial success, regulatory approval prospects, and commercial value.
foxp3+ tregs medical
"Selective Expansion of Functional, Stable FOXP3+ Tregs for the Treatment of Autoimmunity"
FOXP3+ Tregs are a subset of immune cells called regulatory T cells that carry the FOXP3 protein and act like the immune system’s brakes, calming inflammation and preventing the body from attacking itself. They matter to investors because drugs or therapies that boost or block these cells can treat autoimmune diseases, improve transplant outcomes, or alter cancer immunotherapy success, so scientific or regulatory news about them can change the value of biotech assets.
t regulatory cells medical
"induces FOXP3+ antigen-specific induced T regulatory cells (iTregs) from FOXP3-..."
T regulatory cells are a specialized type of immune cell that act like the body’s brake or thermostat, keeping immune responses from becoming too aggressive and preventing damage to healthy tissues. Investors watch them because therapies that boost, suppress, or mimic these cells can treat autoimmune disease, control inflammation, or affect cancer immunotherapy outcomes, so changes in Treg-related science, trial results, or regulation can strongly influence a drug’s safety, effectiveness and market potential.
cd4+ t cells medical
"from FOXP3- conventional CD4+ T cells through the coordinated delivery..."
CD4+ T cells are a type of white blood cell that act as coordinators of the immune system, sending signals that activate and direct other immune cells, like a conductor guiding an orchestra. They are measured in blood tests and used as biomarkers because their number and activity show how well a vaccine, immunotherapy, or infectious-disease treatment is working, which can influence clinical trial outcomes, regulatory decisions and a product’s market potential.
interleukin-2 medical
"delivery of TGF-β and interleukin-2 (IL-2) signals."
A small protein that acts as a signal in the immune system, interleukin-2 tells white blood cells to grow and become more active—think of it as a coach rallying immune players. Investors watch it because drugs that mimic or modify this signal can boost anti‑cancer immunity or treat immune disorders, but they also carry safety risks and regulatory hurdles that affect clinical trial success and commercial value.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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BOSTON, April 15, 2026 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells for the treatment of autoimmune and inflammatory diseases, today announced that it will present new preclinical data for its lead autoimmune and inflammatory disease candidate, CUE-401, as part of a poster at IMMUNOLOGY2026, the annual meeting of the American Association of Immunologists (AAI) taking place in Boston, Massachusetts, April 15-19, 2026.

Poster Presentation Details:

Title: CUE-401: A Novel Bifunctional TGF-beta/IL-2 Fusion Protein that Induces Selective Expansion of Functional, Stable FOXP3+ Tregs for the Treatment of Autoimmunity
Presenter: Natasha M. Girgis, Director, Translational Pharmacology
Date and Time: Saturday, April 18, 2026, 11:30 a.m. – 12:30 p.m. EDT
Poster Number: 733
Session: Therapeutics for Autoimmune Diseases II
Location: Exhibit Hall

As part of the presentation, Dr. Girgis will discuss new in vivo data that supports CUE-401’s ability to induce FOXP3+ antigen-specific induced T regulatory cells (iTregs) from FOXP3- conventional CD4+ T cells through the coordinated delivery of TGF-β and interleukin-2 (IL-2) signals. This new and promising preclinical data supports CUE-401’s therapeutic potential to restore immune homeostasis in autoimmune and inflammatory diseases.

About CUE-401
CUE-401 is a novel bifunctional therapeutic that incorporates an innovative TGF-beta breathing-mask moiety with Cue Biopharma’s clinically validated interleukin-2 (IL-2) mutein in a single injectable biologic. The design of CUE 401 was inspired by Nobel Prize winning science in 2025 for the role of IL-2 and TGF-beta as essential components in helping establish immune tolerance by regulating FOXP3 signaling. CUE-401 is designed to promote immune regulation and tolerance by three complementary mechanisms: 1. Direct regulation of proinflammatory mechanisms by TGF-beta, 2. Expansion of existing Tregs by IL-2, and 3. Conversion of FOXP3- conventional CD4+ T cells into FOXP3+ induced Tregs through the coordinated provision of TGF-beta and IL-2 signals, both of which are required for the de novo induction of FOXP3 expression.

About Cue Biopharma
Cue Biopharma, a clinical-stage biopharmaceutical company, is developing a novel class of injectable biologics to selectively engage and modulate disease-specific T cells directly within the patient’s body. The company’s proprietary platform, Immuno-STAT® (Selective Targeting and Alteration of T cells) and biologics are designed to harness the curative potential of the body’s intrinsic immune system without the adverse effects of broad systemic immune modulation. CUE-401, the company’s lead autoimmune asset, is designed to act mechanistically both as a regulator of proinflammatory mechanisms, and as a master switch for regulatory T cell (Treg) differentiation to induce tolerance. It is a highly innovative, tolerogenic bifunctional molecule combining a TGF-beta breathing-mask moiety with Cue Biopharma’s clinically validated interleukin 2 (IL-2) mutein in a single injectable biologic.

Headquartered in Boston, Massachusetts, we are led by an experienced management team with deep expertise in immunology and protein engineering as well as the design and clinical development of protein biologics.

For more information please visit www.cuebiopharma.com and follow us on X and LinkedIn.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, those regarding: the company’s belief regarding the potential benefits and applications of its drug candidates and programs, including the company’s plans to further advance its differentiating Immuno-STAT® platform and lead autoimmune and inflammatory asset, CUE-401; the company’s belief that CUE-401 has the therapeutic potential to restore immune homeostasis in autoimmune and inflammatory diseases; and the company’s business strategies, plans and prospects. Forward-looking statements, which are based on certain assumptions and describe the company’s future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as “believe,” “expect,” “may,” “will,” “should,” “would,” “could,” “seek,” “intend,” “plan,” “goal,” “project,” “estimate,” “anticipate,” “strategy,” “future,” “likely,” “promise” or other comparable terms, although not all forward-looking statements contain these identifying words. All statements other than statements of historical facts included in this press release regarding the company’s strategies, prospects, financial condition, operations, costs, plans and objectives are forward-looking statements. Important factors that could cause the company’s actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the company’s ability to maintain its collaboration with ImmunoScape; the company’s limited operating history, limited cash and a history of losses; the company’s ability to obtain adequate financing to fund its business operations in the near term and successfully remediate its current “going concern” determination that it does not have sufficient capital on hand to continue operations beyond the next twelve months; the company’s ability to achieve profitability; potential setbacks in the company’s research and development efforts including negative or inconclusive results from its preclinical studies or clinical trials or the company’s ability to replicate in later clinical trials positive results found in preclinical studies and early-stage clinical trials of its product candidates; serious and unexpected drug-related side effects or other safety issues experienced by participants in clinical trials; its ability to secure required U.S. Food and Drug Administration (“FDA”) or other governmental approvals for its product candidates and the breadth of any approved indication; adverse effects caused by public health pandemics, including possible effects on the company’s operations and clinical trials; delays and changes in regulatory requirements, policy and guidelines including potential delays in submitting required regulatory applications to the FDA; the company’s reliance on licensors, collaborators, contract research organizations, suppliers and other business partners; the company’s ability to obtain adequate financing to fund its business operations in the future and ability to continue as a going concern; the company’s ability to maintain and enforce necessary patent and other intellectual property protection; competitive factors; general economic and market conditions and the other risks and uncertainties described in the Risk Factors and Management's Discussion and Analysis of Financial Condition and Results of Operations sections of the company’s most recently filed Annual Report on Form 10-K and any subsequently filed Quarterly Report(s) on Form 10-Q. Any forward-looking statement made by the company in this press release is based only on information currently available to the company and speaks only as of the date on which it is made. The company undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Investor Contact
Marie Campinell
Senior Director, Corporate Communications
Cue Biopharma, Inc.
mcampinell@cuebio.com

Media Contact
Maggie Whitney
LifeSci Communications
mwhitney@lifescicomms.com


FAQ

What will Cue Biopharma (CUE) present about CUE-401 at IMMUNOLOGY2026 on April 18, 2026?

Cue Biopharma will present new preclinical in vivo data for CUE-401 showing selective induction of FOXP3+ iTregs. According to Cue Biopharma, the poster details a TGF-β/IL-2 fusion protein that induces antigen-specific regulatory T cells in animal models, supporting therapeutic potential.

What is CUE-401 and how does it work according to Cue Biopharma (CUE)?

CUE-401 is a bifunctional TGF-β/IL-2 fusion designed to expand functional FOXP3+ Tregs selectively. According to Cue Biopharma, coordinated delivery of TGF-β and IL-2 signals converts FOXP3- CD4+ T cells into antigen-specific induced regulatory T cells in preclinical studies.

When and where is the CUE-401 poster presentation by Cue Biopharma (CUE) at IMMUNOLOGY2026?

The poster presentation is scheduled for Saturday, April 18, 2026, 11:30 a.m.–12:30 p.m. EDT in the Exhibit Hall. According to Cue Biopharma, it is poster number 733 in the Therapeutics for Autoimmune Diseases II session.

Who is presenting Cue Biopharma's (CUE) CUE-401 data at IMMUNOLOGY2026?

Dr. Natasha M. Girgis, Director of Translational Pharmacology, will present the CUE-401 poster. According to Cue Biopharma, Dr. Girgis will discuss in vivo findings on antigen-specific FOXP3+ iTreg induction and therapeutic implications for autoimmunity.

What preclinical evidence does Cue Biopharma (CUE) claim supports CUE-401's therapeutic potential?

Cue Biopharma reports in vivo data showing CUE-401 induces stable, functional FOXP3+ antigen-specific iTregs from conventional CD4+ T cells. According to Cue Biopharma, this supports potential to restore immune homeostasis in autoimmune and inflammatory disease models.

Will Cue Biopharma's (CUE) IMMUNOLOGY2026 presentation include clinical trial results for CUE-401?

No, the IMMUNOLOGY2026 presentation covers new preclinical in vivo data, not clinical trial results. According to Cue Biopharma, the poster focuses on mechanistic and animal-model evidence for CUE-401's ability to induce antigen-specific regulatory T cells.