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Cue Biopharma Reports First Quarter 2026 Financial Results and Recent Strategic Developments

(Positive)
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Cue Biopharma (Nasdaq:CUE) reported Q1 2026 collaboration revenue of $5.7 million, up from $0.4 million in Q1 2025, and a net loss of $5.2 million, reduced from $12.3 million. R&D expenses fell to $6.9 million, G&A held at $4.2 million.

The company licensed CUE-221, a Phase 2 anti-IgE asset for allergic disease, and advanced CUE-401, an autoimmune candidate. Liquidity was strengthened by a $30 million private placement and a $7.5 million milestone from Boehringer Ingelheim. Shao-Lee Lin, M.D., Ph.D., was appointed President and CEO.

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Positive

  • Collaboration revenue rose to $5.7 million from $0.4 million year-over-year
  • Net loss narrowed to $5.2 million from $12.3 million year-over-year
  • Research and development expenses decreased to $6.9 million from $8.5 million
  • Completed $30 million private placement, with approximately $28 million in net proceeds
  • Received $7.5 million milestone from Boehringer Ingelheim collaboration
  • Exclusive license obtained for Phase 2 anti-IgE asset CUE-221

Negative

  • Company remains loss-making with Q1 2026 net loss of $5.2 million
  • Cash and cash equivalents declined to $16.4 million from $27.1 million since year-end
  • Total assets fell to $30.9 million from $42.2 million quarter-over-quarter
  • 1-for-30 reverse stock split effective April 23, 2026

News Market Reaction – CUE

-9.16%
15 alerts
-9.16% Session close to close
-23.1% Trough in 24 hr 41 min
$89.91M Market Cap
0.1x Rel. Volume

In the May 15 session, CUE declined 9.16%, reflecting a notable negative market reaction. Argus tracked a trough of -23.1% from its starting point during tracking. Our momentum scanner triggered 15 alerts that day, indicating notable trading interest and price volatility.

Data tracked by StockTitan Argus on the day of publication.

Market Context

The stock moved -9.2% in the session following this news. A negative reaction despite operational pr...
Analysis

The stock moved -9.2% in the session following this news. A negative reaction despite operational progress would fit prior earnings patterns, where the average move was -6.58% following results. This Q1 2026 update combined higher collaboration revenue, a smaller net loss, and added financing, yet the presence of an unused $300,000,000 shelf and recent private placement could heighten dilution concerns. Past behavior suggests that even fundamentally constructive news has sometimes been met with selling pressure after earnings releases.

Key Figures

Q1 2026 revenue: $5.7 million Q1 2025 revenue: $0.4 million R&D expenses: $6.9 million +5 more
8 metrics
Q1 2026 revenue $5.7 million Collaboration revenue for quarter ended March 31, 2026
Q1 2025 revenue $0.4 million Collaboration revenue for quarter ended March 31, 2025
R&D expenses $6.9 million Three months ended March 31, 2026
Net loss $5.2 million Three months ended March 31, 2026
Cash & equivalents $16.4 million As of March 31, 2026
Private placement $30 million Gross proceeds from pre-funded and common warrants financing
Milestone payment $7.5 million Preclinical milestone from Boehringer Ingelheim collaboration
Shelf registration $300,000,000 Maximum amount on S-3 filed March 17, 2026

Previous Earnings Reports

5 past events · Latest: Mar 16 (Positive)
Same Type Pattern 5 events
Date Event Sentiment 24h Move Catalyst
Mar 16 Q4/FY 2025 results Positive -12.8% Reported Q4 and full-year 2025 results plus ImmunoScape collaboration and financing.
Nov 12 Q3 2025 results Positive -7.2% Q3 2025 results with ImmunoScape deal and strong CUE-101 clinical data.
Aug 12 Q2 2025 results Positive +2.6% Q2 2025 results plus Boehringer collaboration and public offering.
May 12 Q1 2025 results Positive +2.3% Q1 2025 results with Boehringer deal and follow-on offering.
Mar 31 Q4/FY 2024 results Positive -17.7% Q4 and full-year 2024 results with lower expenses and leadership changes.

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

Pattern Detected

Recent earnings releases have often been operationally positive but followed by share price weakness, with an average move of -6.58% across the last five earnings events.

Recent Company History

Over the last five earnings-related updates from March 2025 through March 2026, Cue Biopharma has consistently paired financial results with strategic steps: collaborations with Boehringer Ingelheim and ImmunoScape, advancement of CUE-401 and CUE-501, and cost reductions in R&D and G&A. Cash balances ranged from $11.7M to $27.5M full-year revenue, while net losses persisted. Against that backdrop, this Q1 2026 release adds higher collaboration revenue and a reduced net loss, plus newly emphasized pipeline assets CUE-221 and CUE-401.

Key Terms

pre-funded warrants, common warrants, investigational new drug (ind), u.s. food and drug administration (fda), +4 more
8 terms
pre-funded warrants financial
"Completed a private placement of pre-funded warrants and accompanying common warrants for gross proceeds..."
Pre-funded warrants are financial instruments that give investors the right to purchase a company's stock at a set price, but with most or all of the purchase price paid upfront. They function like a coupon or gift card for stock, allowing investors to buy shares later at a fixed price, which can be beneficial if they want to avoid future price increases. This makes them important for investors seeking flexibility and certainty in their investment plans.
common warrants financial
"Completed a private placement of pre-funded warrants and accompanying common warrants for gross proceeds..."
A common warrant is a tradable instrument that gives its holder the right to buy a company’s common shares at a fixed price within a set time period, similar to a coupon that can be redeemed later to purchase stock. Investors care because exercising warrants can boost potential gains if the stock rises, but it can also dilute existing shareholders by increasing the number of shares outstanding, which can lower per-share value.
investigational new drug (ind) regulatory
"Cue expects to submit an Investigational New Drug (IND) amendment to the U.S. Food and Drug Administration..."
An investigational new drug (IND) is a drug or biologic that is being tested but has not yet been approved for general use; it is the application and formal status that allows a company to begin human clinical trials under regulator oversight. Investors care because an IND marks the transition from lab work to human testing — like getting a permit to run real-world experiments — which creates important milestones, costs, timelines and regulatory risk that drive a development-stage company's value.
u.s. food and drug administration (fda) regulatory
"Cue expects to submit an Investigational New Drug (IND) amendment to the U.S. Food and Drug Administration (FDA)..."
The U.S. Food and Drug Administration (FDA) is a government agency responsible for protecting public health by ensuring the safety and effectiveness of food, medicines, vaccines, and other health-related products. For investors, the FDA’s decisions can significantly impact companies in the healthcare and food industries, as approval or rejection of products can influence a company's success and stock performance.
phase 2 medical
"CUE-221, a Phase 2 program targeting allergic disease..."
Phase 2 is the mid-stage clinical trial where a new drug or treatment is tested in a larger group of patients to see if it works and to keep checking safety after initial human testing. Think of it as a field test that proves whether a product actually delivers its promised benefit. Investors watch Phase 2 closely because its results strongly influence a medicine’s chances of reaching the market, the size of its potential sales, and the company’s valuation.
phase 1 medical
"Phase 1 first-in-human study expected to be initiated by year-end 2026."
Phase 1 is the first stage of testing a new drug or medical treatment in people, focused primarily on safety, how the body handles the product, and finding a tolerated dose. Think of it as a short, tightly controlled experiment with a small group to check for dangerous side effects before wider testing; for investors it is an early milestone that reduces some uncertainty but still carries high risk and potential for both big value changes and setbacks.
reverse stock split financial
"retroactively restated to reflect the one-for-thirty (1-for-30) reverse stock split..."
A reverse stock split reduces a company's number of outstanding shares while raising the price per share proportionally, so the total value of each investor's holding is unchanged; a 1-for-10 split turns 100 shares worth $1 each into 10 shares worth $10 each. Companies often do this to regain compliance with an exchange's minimum price rule or to attract investors who avoid very low-priced stocks.
bifunctional cytokine medical
"CUE-401, a potential first-in-class bifunctional cytokine designed to induce tolerance..."
A bifunctional cytokine is an immune signaling protein that performs two distinct biological actions or interacts with two different targets, like a Swiss Army knife with two useful tools. For investors, this matters because such molecules can offer broader therapeutic potential or multi-pronged effects in a single drug, which can increase value but also raise development complexity, safety testing and regulatory scrutiny.

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

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Moves designed to strengthen leadership and financial position, advance portfolio, and leverage expertise in precision immunoengineering

  • Enhanced the company’s portfolio with an exclusive license for, CUE-221, a Phase 2 program targeting allergic disease

  • Hosted virtual R&D day showcasing CUE-401, a bifunctional IL-2 and TGF-B program targeting autoimmune disease

  • Strengthened the company’s balance sheet and ability to fund anticipated cash needs with a $30 million private placement and received a $7.5 million milestone payment under a collaboration and license agreement

  • Appointed Shao-Lee Lin, M.D., Ph.D., as President, CEO and Board Director to lead continued growth and transformation into a clinical-stage company.

BOSTON, May 14, 2026 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical stage therapeutics company focused on developing transformative therapies targeting functional cures for immunological disorders, today reported first quarter 2026 financial results and highlighted recent corporate progress and upcoming milestones.

“We are excited to advance our enhanced portfolio targeting the potential for functional cures for allergic and autoimmune diseases with high unmet need. Our newly expanded pipeline reflects our strengthened strategy and position in anticipation of significant value-driving milestones in the second half of 2026,” said Shao-Lee Lin, M.D., Ph.D., president and chief executive officer of Cue Biopharma. “With the recent financing, we believe our current cash runway will be sufficient to support the execution of our expected clinical milestones for CUE-221 and CUE-401. As a team, we look forward to leveraging our strength in precision immunoengineering to advance these assets and create long-term shareholder value to provide transformative therapies for patients.”

Business Highlights

Pipeline and Strategy

  • Enhanced pipeline with CUE-221 (formerly known as Ascendant-221), a late-stage novel clinical anti-IgE asset with a dual-mechanism through an exclusive license from Ascendant Health Sciences Ltd (Ascendant Health).

  • Hosted a virtual R&D Day focused on CUE-401, a potential first-in-class bifunctional cytokine designed to induce tolerance in autoimmune and inflammatory diseases.

Financial and Corporate

  • Completed a private placement of pre-funded warrants and accompanying common warrants for gross proceeds of approximately $30 million, before placement agent fees and offering expenses, and aggregate net proceeds of approximately $28 million, to support the company’s clinical pipeline, including advancing CUE-221.

  • Received a $7.5 million preclinical milestone payment under the Boehringer Ingelheim collaboration and license agreement for the selection and approval of Boehringer Ingelheim’s first compound for lead optimization.

Leadership

  • Appointed a new President and CEO, Shao-Lee Lin, M.D., Ph.D., a biopharmaceutical executive and physician scientist with 25 years of experience in core immunology experience who has helped build multi-billion-dollar portfolios, built strong teams, and taken a company from inception to IPO. Additional executives join Cue's legacy team in forming a growing complement of clinical and preclinical expertise across the company.

Upcoming Milestones

CUE-221:

  • Cue expects to submit an Investigational New Drug (IND) amendment to the U.S. Food and Drug Administration (FDA) to expand development into food allergy in the second half of 2026.

  • Results from Ascendant Health’s ongoing China Phase 2 placebo-and active-controlled dose-ranging study in Chronic Spontaneous Urticaria are expected in the second half of 2026.

  • Plan to initiate global, Phase 2b trial in food allergy pending Cue’s review of results from Ascendant Health’s ongoing the China Phase 2 CSU study results.

CUE-401:

  • Cue expects to submit an IND to the FDA in the second half of 2026.

  • Phase 1 first-in-human study expected to be initiated by year-end 2026.

First Quarter 2026 Financial Results
First quarter revenue was $5.7 million compared to $0.4 million in the first quarter of 2025. The revenue earned during the three months ended March 31, 2026 was related to the Boehringer Ingelheim collaboration and license agreement. The revenue earned during the three months ended March 31, 2025 was related to the agreement with Ono Pharmaceutical, which was terminated in March 2025.

Research and development expenses were $6.9 million for the three months ended March 31, 2026 compared to $8.5 million in 2025. The decrease was primarily due to lower clinical trial costs for the company’s CUE-100 series, as well as decreases in expenditure for total employee compensation due to attrition.

General and administrative expenses were $4.2 million for both the three months ended March 31, 2026 and 2025.

Net loss for the three months ended March 31, 2026 was $5.2 million compared to $12.3 million in 2025.
        
As of March 31, 2026, the Company had $16.4 million in cash and cash equivalents. Subsequent to March 31, 2026, the Company has completed a $30 million private placement financing and also received a milestone payment of $7.5 million from Boehringer Ingelheim.

Cue Biopharma, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited, In thousands, except share and per share amounts)
  
 Three Months Ended March 31,
 2026
 2025
Collaboration revenue$5,686  $421 
Operating expenses:   
General and administrative 4,152   4,173 
Research and development 6,897   8,547 
(Gain) on lease termination (10)   
Total operating expenses 11,039   12,720 
Loss from operations (5,353)  (12,299)
Other income (expense):   
Interest income 179   170 
Interest expense (4)  (128)
Total other income, net 175   42 
Net loss$(5,178) $(12,257)
Net loss per common share – basic and diluted$(1.08) $(4.95)
Weighted average common shares outstanding – basic and diluted 4,807,494   2,475,156 
    

____________________________________________________
(*) The number of shares and per share amounts have been retroactively restated to reflect the one-for-thirty (1-for-30) reverse stock split, which was effective on April 23, 2026.  


Cue Biopharma, Inc.
Condensed Consolidated Balance Sheets
(Unaudited, In thousands)
      
 March 31, 2026
 December 31, 2025
Assets     
Cash and cash equivalents$16,379  $27,136 
Other assets 14,498   15,076 
Total assets$30,877  $42,212 
Liabilities and stockholders’ equity     
Liabilities$9,269  $15,780 
Stockholders' equity 21,608   26,432 
Total liabilities and stockholders’ equity$30,877  $42,212 
      


About Cue Biopharma

Cue Biopharma (Nasdaq: CUE) is a clinical stage therapeutics company focused on advancing a portfolio of potentially transformative therapies aimed at enabling functional cures across immunological disorders. Its lead asset is a novel anti-IgE antibody with a dual-mechanism of action, currently in Phase 2 development for allergic diseases. In addition, Cue developed the Immuno-STAT® platform which selectively targets disease-specific T cells in vivo without broad immune modulation. Its lead autoimmune candidate, CUE-401, is advancing towards Phase 1 and was designed to regulate inflammation and drive Treg-mediated tolerance. Cue is led by an experienced management team with deep expertise in identifying, acquiring, and advancing promising drug candidates.

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

Cautionary Note Regarding 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 assets, including CUE-401 and CUE-221, including anticipated timing for regulatory submissions and initiation of clinical trials; the anticipated timeline for reporting data from Ascendant Health’s China Phase 2 study for CUE-221; the potential therapeutic benefits of the company’s assets, including CUE-401 and CUE-221; and the sufficiency of the company’s current cash and cash equivalents to fund its anticipated clinical milestones for CUE-401 and CUE-221 for the remainder of 2026. 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 and establish collaboration, licensing and other arrangements; 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 for its current and future drug product candidates, 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; potential challenges associated with clinical trials conducted in China and the company’s access to, and acceptability of, the data therefrom; its ability to secure required  FDA or other governmental approvals for its product candidates and the breadth of any approved indication; 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 and Media Contact
Agnes Lee
Chief Officer of Public and Investor Relations

Marie Campinell
Senior Director, Corporate Communications

ir@cuebio.com
Cue Biopharma, Inc.


FAQ

How did Cue Biopharma (CUE) perform financially in Q1 2026?

Cue Biopharma reported Q1 2026 revenue of $5.7 million and a net loss of $5.2 million. According to Cue Biopharma, higher collaboration revenue and lower R&D expenses versus 2025 significantly narrowed the quarterly loss while maintaining investment in its immunology pipeline.

What are the key strategic developments Cue Biopharma (CUE) announced for CUE-221?

Cue Biopharma secured an exclusive license for CUE-221, a Phase 2 anti-IgE program for allergic disease. According to Cue Biopharma, it plans an IND amendment for food allergy and may start a global Phase 2b trial after reviewing China Phase 2 CSU results.

What progress did Cue Biopharma (CUE) report on its CUE-401 autoimmune program?

Cue Biopharma highlighted CUE-401, a bifunctional IL-2/TGF-β cytokine candidate targeting autoimmune and inflammatory diseases. According to Cue Biopharma, it expects to file an IND in the second half of 2026 and start a Phase 1 first-in-human study by year-end 2026.

How did Cue Biopharma (CUE) strengthen its balance sheet in 2026?

Cue Biopharma completed a $30 million private placement and received a $7.5 million milestone payment. According to Cue Biopharma, these funds support clinical development of CUE-221 and CUE-401 and extend its ability to meet anticipated cash needs.

Who is the new CEO of Cue Biopharma (CUE) and what is the leadership focus?

Cue Biopharma appointed Shao-Lee Lin, M.D., Ph.D., as President, CEO, and Board Director. According to Cue Biopharma, the new leadership, alongside added clinical experts, is focused on transforming the company around its clinical-stage allergic and autoimmune programs.

What did Cue Biopharma (CUE) report about its cash position at March 31, 2026?

Cue Biopharma reported $16.4 million in cash and cash equivalents at March 31, 2026. According to Cue Biopharma, this balance excludes subsequent $30 million financing proceeds and the $7.5 million milestone payment received after quarter-end.

Did Cue Biopharma (CUE) implement a reverse stock split in 2026?

Cue Biopharma implemented a 1-for-30 reverse stock split effective April 23, 2026. According to Cue Biopharma, share and per-share amounts in its Q1 2026 results were retroactively restated to reflect this reverse split for comparability.