Cue Biopharma Reports Fourth Quarter and Full Year 2025 Financial Results and Business Highlights

• Advanced research and development of CUE-401 for IND (Investigational New Drug) readiness –
  CUE-401 is the Company’s lead asset for the treatment of autoimmune and inflammatory diseases
  
  
• Appointed industry veteran Lucinda Warren as Chief Financial and Business Officer
  
  
• Raised net proceeds of $10.2M through an underwritten public offering
  
  
• Announced strategic collaboration and license agreement with ImmunoScape to develop breakthrough cell therapy approach for solid tumors – Entitled to receive upfront payments totaling $15M
  
  

BOSTON, March 16, 2026 -- 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 reported fourth quarter and full year 2025 financial results.

“During the fourth quarter and throughout the full year 2025, the Company successfully met its strategic development goals and objectives that demonstrated significant progress towards establishing potential first-in-class and best-in-class assets for patients suffering with autoimmune diseases,” said Usman Azam, M.D., president and chief executive officer of Cue Biopharma. “With these strategic deliverables and continued progress to date, we believe we are well positioned to further advance our differentiating Immuno-STAT

 platform and lead autoimmune asset, CUE-401, toward the clinic to address major unmet needs in autoimmune disease treatment.”

Business Highlights

• Advanced research and development of CUE-401 for IND (Investigational New Drug) readiness
  • Conducted toxicology and pharmacology studies and announced preclinical safety and tolerability data
    • In two non-GLP studies, CUE-401 was well tolerated with no adverse events observed
    • Proof-of concept studies reinforce promising preclinical profile and therapeutic potential of CUE-401
  • Presented in vivo and in vitro data that demonstrate the therapeutic potential of CUE-401 to restore immune balance for the treatment of autoimmune and inflammatory diseases at the World Immune Regulation Meeting (WIRM) held March 11-14, 2026
• Announced strategic collaboration and license agreement with ImmunoScape to develop breakthrough cell therapy approach for solid tumors
  • Entitled to upfront payments totaling $15 million. Of these payments, received $9.5 million, net of withholding taxes in the fourth quarter of 2025, and entitled to receive an additional $5 million in November 2026
  • Received a 40% equity stake in ImmunoScape, and the Company is eligible for high-single digit royalties
• Company plans to announce Virtual R&D Day event highlighting CUE-401, the company’s lead autoimmune asset, within the next couple of weeks. CUE-401 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.
  
  

Fourth Quarter 2025 Financial Results
The Company reported collaboration revenue of $21.9 million and $1.6 million for the three months ended December 31, 2025 and 2024, respectively. The increase was primarily due to revenue recognized from the collaboration and license agreement with ImmunoScape in the fourth quarter of 2025.

Research and development expenses were $16.5 million and $7.2 million for the three months ended December 31, 2025 and 2024, respectively. The increase was primarily due to an increase in drug substance manufacturing and lab costs for CUE-401, an increase from one-time acquired in-process research and development costs in connection with our collaboration and license agreement with ImmunoScape, and an increase in license fees payable to Einstein in connection with the collaboration and license agreement with ImmunoScape. These increases were partially offset by a decrease in employee compensation, which includes stock-based compensation, due to a reduction in headcount, as well as a decrease in clinical trial costs as a result of licensing molecules from the CUE-100 series to ImmunoScape.

General and administrative expenses were $3.5 million and $4.0 million for the three months ended December 31, 2025 and 2024, respectively. The decrease was primarily due to a decrease in employee compensation, which includes stock-based compensation, due to a reduction in headcount, partially offset by an increase in severance paid to our former chief executive officer, as well as an increase in professional fees related to the review, negotiation, and preparation of the collaboration and license agreement with ImmunoScape.

Full Year 2025 Financial Results
The Company reported collaboration revenue of $27.5 million and $9.3 million for the years ended December 31, 2025 and 2024, respectively. The increase was primarily due to revenue earned from our collaboration and license agreement entered into with ImmunoScape in the fourth quarter of 2025.

Research and development expenses were $37.7 million and $36.3 million for the years ended December 31, 2025 and 2024, respectively. The increase was primarily due to one-time acquired in-process research and development costs in connection with our collaboration and license agreement with ImmunoScape, an increase in drug substance manufacturing and lab costs for CUE-401, and an increase in license fees payable to Einstein in connection with the collaboration and license agreement with ImmunoScape. These increases were partially offset by a decrease in employee compensation, which includes stock-based compensation, due to a reduction in headcount, as well as a decrease in clinical trial costs as a result of licensing molecules from the CUE-100 series to ImmunoScape.

General and administrative expenses were $16.2 million and $14.6 million for the years ended December 31, 2025 and 2024, respectively. The increase was primarily due to an increase in professional fees, which included fees incurred for the review, negotiation, and preparation of our 2025 collaboration and license agreements and an increase in severance paid to our former chief executive officer, partially offset by a decrease in employee compensation, which includes stock-based compensation, due to a reduction in headcount.

As of December 31, 2025, the Company had $27.1 million in cash and cash equivalents. 

Cue Biopharma, Inc.
Consolidated Statements of Operations and Comprehensive Income (Loss)
(In thousands, except share and per share amounts)
		Three Months Ended December 31,								Years Ended December 31,
		2025				2024				2025				2024
Collaboration revenue		$	21,942			$	1,576			$	27,466			$	9,287
Operating expenses (income):
General and administrative			3,452				4,021				16,244				14,585
Research and development			16,532				7,184				37,743				36,295
(Gain) loss on fixed asset disposal			(20	)			4				31				(93	)
Total operating expenses			19,964				11,209				54,018				50,787
Income (loss) from operations			1,978				(9,633	)			(26,552	)			(41,500	)
Other income (expense):
Interest income			158				290				807				1,622
Interest expense			(51	)			(153	)			(357	)			(796	)
Total other income, net			107				137				450				826
Income (loss) before provision for income taxes			2,085				(9,496	)			(26,102	)			(40,674	)
Provision for income taxes			(500	)			—				(500	)			—
Net income (loss)		$	1,585			$	(9,496	)		$	(26,602	)		$	(40,674	)
Unrealized loss from available-for-sale securities			(1	)			—				—				—
Comprehensive income (loss)		$	1,584			$	(9,496	)		$	(26,602	)		$	(40,674	)
Net income (loss) per common share – basic		$	0.01			$	(0.13	)		$	(0.28	)		$	(0.72	)
Net income (loss) per common share – diluted		$	0.01			$	(0.13	)		$	(0.28	)		$	(0.72	)
Weighted average common shares outstanding – basic			107,988,413				74,238,329				94,731,768				56,328,348
Weighted average common shares outstanding – diluted			110,512,936				74,238,329				94,731,768				56,328,348

Cue Biopharma, Inc. Consolidated Balance Sheets (In thousands)
		December 31, 2025				December 31, 2024
Assets
Cash and cash equivalents		$	27,136			$	22,459
Other assets			15,076				9,732
Total assets		$	42,212			$	32,191
Liabilities and stockholders’ equity
Liabilities		$	15,780			$	14,692
Stockholders' equity			26,432				17,499
Total Liabilities and stockholders’ equity		$	42,212			$	32,191

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.

Cautionary Note Regarding Forward-Looking Statements