Cue Biopharma Reports Fourth Quarter and Full Year 2024 Financial Results and Business Highlights

Rhea-AI Summary

Cue Biopharma (Nasdaq: CUE) reported its Q4 and full year 2024 financial results. The company's collaboration revenue for Q4 2024 was $1.6 million, down from $1.8 million in Q4 2023. Full-year collaboration revenue increased to $9.3 million from $5.5 million in 2023, driven by the Ono Pharmaceutical partnership.

R&D expenses decreased to $7.2 million in Q4 2024 from $10.9 million in Q4 2023, while G&A expenses reduced to $4.0 million from $4.6 million. For the full year, R&D expenses were $36.3 million (down from $40.8 million) and G&A expenses were $14.6 million (down from $16.7 million).

The company appointed new leadership including Lucinda Warren as Chief Business Officer and Daniel Baker as Interim Chief Development Officer. Cue regained worldwide rights for CUE-401, their lead autoimmune program, and advanced CUE-501 development. Cash position stood at $22.5 million as of December 31, 2024.

Positive

• Full-year collaboration revenue increased 69% to $9.3 million
• Reduced R&D expenses by 11% to $36.3 million
• Decreased G&A expenses by 13% to $14.6 million
• Regained worldwide rights for lead autoimmune program CUE-401

Negative

• Q4 collaboration revenue declined 11% to $1.6 million
• Going concern warning about insufficient capital for operations beyond 12 months
• operating history and history of losses
• Cash position of $22.5 million may require additional financing

Insights

Financial Analyst

Cue Biopharma's Q4 and FY2024 results reveal concerning financial dynamics despite strategic realignment efforts. Annual revenue increased to $9.3 million from $5.5 million in 2023, primarily driven by their Ono Pharmaceutical collaboration. While management has successfully reduced operational expenses - R&D costs decreased to $36.3 million from $40.8 million and G&A expenses fell to $14.6 million from $16.7 million - these reductions appear insufficient relative to their cash position.

The $22.5 million cash balance as of December 31, 2024, represents an extremely concerning runway given their quarterly burn rate. Most alarming is the explicit "going concern" language in their forward-looking statements, acknowledging insufficient capital to operate beyond 12 months without additional financing. With combined annual expenses still exceeding $50 million, their current cash would support operations for less than 6 months without further significant cost reductions or capital infusion.

This financial reality is likely driving their strategic pivot toward autoimmune programs while seeking partnerships for oncology assets - a move that appears more financially necessary than strategically opportunistic. The company's ability to negotiate favorable partnership terms is substantially weakened by their transparent cash constraints, potentially forcing disadvantageous deals to extend runway. Immediate financing appears necessary, which would likely dilute existing shareholders substantially given their $62 million market cap against current cash needs.

Biotech Research Analyst

Cue Biopharma's strategic reshuffling toward autoimmune programs represents a significant directional shift. Their regaining of worldwide rights to CUE-401 suggests management sees greater value potential in this asset compared to their oncology portfolio. This aligns with broader industry recognition that targeted autoimmune therapies represent substantial market opportunities, particularly those offering improvements over current treatment paradigms that carry significant side effect profiles.

The advancement of CUE-501 from their CUE-500 series further demonstrates this pivot, positioning their Immuno-STAT platform to potentially address both autoimmune and oncology indications. The strategic appointments of industry veterans to leadership positions - including a Chief Business Officer with transaction expertise and an experienced interim Chief Development Officer - signals preparation for potential partnership negotiations and focused clinical development.

However, the significant reduction in clinical trial costs (evident in the R&D expense decrease) raises questions about pipeline momentum. While described as prioritization, these cuts could potentially slow data generation necessary to attract partners or investors. The company's explicit acknowledgment of financial constraints creates a problematic timeline mismatch - biotech asset development typically requires years, while their current resources appear significantly more This fundamental disconnect between financial reality and development timelines creates substantial execution risk despite the potential scientific merit of their platform technology.

BOSTON, March 31, 2025 (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 cancer and autoimmune disease, today reported fourth quarter and full year 2024 financial results.

• Prioritized resources on potentially disruptive autoimmune programs while enabling maturation of clinical data from oncology programs to further support prospective strategic partnerships
  
  
• Appointed key industry leaders to management team and board of directors
  • Lucinda Warren, Chief Business Officer
    Industry veteran, with extensive experience and proven expertise in strategic transactions, portfolio optimization and alliance management
  • Daniel Baker, M.D., Interim Chief Development Officer
    Over 20 years of drug development experience in the pharmaceutical industry
  • Pasha Sarraf, M.D., Ph.D., Member of Board of Directors
    Physician-scientist with extensive experience in the business of science and biotechnology
    
    
• Successfully regained worldwide development and commercialization rights for CUE-401, the Company’s lead autoimmune program with potential to transform treatment across a broad spectrum of autoimmune and inflammatory diseases
  
  
• Advanced research and development of CUE-501 as lead program of the CUE-500 series, demonstrating the potential to harness anti-viral specific T cells against pathogenic cells in both autoimmune and oncology
  
  
• Company plans to announce business update call and webcast within the next couple of weeks

“During 2024 and Q1 2025, we made significant progress shaping the company for success,” said Daniel Passeri, chief executive officer of Cue Biopharma. “We believe that the ongoing advancement of our prioritized autoimmune programs and the implementation of a highly focused strategic business model, support our ability to exploit the potentially disruptive opportunity of our Immuno-STAT™ platform, specifically CUE-401.”

Fourth Quarter 2024 Financial Results

The Company reported collaboration revenue of $1.6 million and $1.8 million for the three months ended December 31, 2024 and 2023, respectively. The decrease was due to revenue earned from the strategic collaboration agreement entered into with Ono Pharmaceutical in the first quarter of 2023.

Research and development expenses were $7.2 million and $10.9 million for the three months ended December 31, 2024 and 2023, respectively. The decrease was primarily due to decreases in both drug substance manufacturing and clinical trial costs.

General and administrative expenses were $4.0 million and $4.6 million for the three months ended December 31, 2024 and 2023, respectively. The decrease was primarily due to a decrease in professional fees.
        
Full Year 2024 Financial Results

The Company reported collaboration revenue of $9.3 million and $5.5 million for the years ended December 31, 2024 and 2023, respectively. The increase was due to revenue earned from our strategic collaboration agreement entered into with Ono Pharmaceutical in the first quarter of 2023.

Research and development expenses were $36.3 million and $40.8 million for the years ended December 31, 2024 and 2023, respectively. The decrease was primarily due to decreases in clinical trial costs, employee compensation, which includes stock-based compensation, and manufacturing costs.

General and administrative expenses were $14.6 million and $16.7 million for the years ended December 31, 2024 and 2023, respectively. The decrease was primarily due to decreases in employee compensation, which includes stock-based compensation, and professional fees.

As of December 31, 2024, the Company had $22.5 million in cash and cash equivalents. 

Cue Biopharma, Inc.
Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
		Three Months Ended December 31,								Year Ended December 31,
		2024				2023				2024							2023
Collaboration revenue	$	1,576			$	1,821			$	9,287						$	5,490
Operating expenses (income):
General and administrative		4,021				4,609				14,585							16,680
Research and development		7,184				10,887				36,295							40,802
Loss (gain) on fixed asset disposal		4				157				(93				)			157
Total operating expenses		11,209				15,653				50,787							57,639
Loss from operations	$	(9,633	)		$	(13,832	)		$	(41,500				)		$	(52,149		)
Other income (expense):
Interest income		290				905				1,622							2,661
Interest expense		(153	)			(507	)			(796				)			(1,245		)
Total other income, net		137				398				826							1,416
Net loss	$	(9,496	)		$	(13,434	)		$	(40,674				)		$	(50,733		)
Unrealized gain from available-for-sale securities		-				-					-							96
Comprehensive loss		(9,496	)			(13,434	)				(40,674	)						(50,637	)
Net loss per common share – basic and diluted	$	(0.13	)		$	(0.28	)		$	(0.72				)		$	(1.11		)
Weighted average common shares outstanding – basic and diluted		74,238,329				47,181,633				56,328,348							45,754,794

Cue Biopharma, Inc. Consolidated Balance Sheets (In thousands)
		December 31, 2024				December 31, 2023
Assets
Cash and cash equivalents	$	22,459			$	48,514
Other assets		9,732				13,016
Total assets	$	32,191			$	61,530
Liabilities and stockholders’ equity
Liabilities	$	14,692			$	24,445
Stockholders' equity		17,499				37,085
Total Liabilities and stockholders’ equity	$	32,191			$	61,530

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 through the selective modulation of disease-specific T cells without the adverse effects of broad systemic immune modulation.

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.

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 that CUE-401 has potential to transform treatment across a broad spectrum of autoimmune and inflammatory diseases; the potential therapeutic benefits of CUE-501 and the CUE-500 series; the company’s ability to advance its Immuno-STAT™ platform; 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” 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 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 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
Jonathan Pappas
LifeSci Communications
jpappas@lifescicomms.com

FAQ

What were Cue Biopharma's (CUE) Q4 2024 financial results?

CUE reported Q4 2024 collaboration revenue of $1.6 million, R&D expenses of $7.2 million, and G&A expenses of $4.0 million.

How much cash does Cue Biopharma (CUE) have as of December 2024?

Cue Biopharma had $22.5 million in cash and cash equivalents as of December 31, 2024.

What progress did Cue Biopharma (CUE) make with its autoimmune programs in 2024?

CUE regained worldwide rights for CUE-401, their lead autoimmune program, and advanced CUE-501 development for both autoimmune and oncology applications.

How did Cue Biopharma's (CUE) full-year 2024 revenue compare to 2023?

Full-year collaboration revenue increased to $9.3 million in 2024 from $5.5 million in 2023, primarily due to the Ono Pharmaceutical partnership.