Cue Biopharma Narrows Losses, Boosts Cash with ImmunoScape Deal

TL;DR

**CUE is still burning cash, but the ImmunoScape deal is a crucial, albeit temporary, shot in the arm for its going concern risk.**

AI Summary

Cue Biopharma, Inc. reported a net loss of $7.448 million for the three months ended September 30, 2025, an improvement from a net loss of $8.660 million in the same period of 2024. For the nine months ended September 30, 2025, the net loss was $28.187 million, compared to $31.178 million in 2024. Collaboration revenue decreased to $2.149 million for the quarter, down from $3.336 million year-over-year, and to $5.524 million for the nine months, down from $7.711 million. Research and development expenses significantly decreased to $4.754 million for the quarter from $9.381 million, and to $21.211 million for the nine months from $29.111 million. The company's cash and cash equivalents stood at $11.701 million as of September 30, 2025, a substantial drop from $22.459 million at December 31, 2024. However, a subsequent event on November 6, 2025, involved a Collaboration and License Agreement with ImmunoScape Pte. Ltd., entitling Cue Biopharma to $15.0 million in upfront payments, with $5.0 million already received and another $5.0 million expected in Q4 2025.

Why It Matters

This 10-Q filing reveals Cue Biopharma's ongoing struggle with profitability, marked by recurring losses and a significant burn rate, which raises substantial doubt about its ability to continue as a going concern. For investors, the recent $15.0 million upfront payment from ImmunoScape is a critical lifeline, providing much-needed capital to extend its operational runway and fund its clinical-stage pipeline, particularly the autoimmune programs CUE-401 and CUE-500 series. However, the company still faces intense competition in the biopharmaceutical space and relies heavily on third parties for clinical trials and manufacturing, adding layers of execution risk. Employees and customers will be watching closely to see if this new funding can translate into sustained progress and eventual product commercialization, especially given the company's lack of FDA-approved products.

Risk Assessment

Risk Level: high — The company explicitly states, "Our recurring losses from operations raise substantial doubt regarding our ability to continue as a going concern." As of September 30, 2025, cash and cash equivalents were only $11.701 million, down from $22.459 million at December 31, 2024, indicating a rapid cash burn. While the ImmunoScape deal provides $15.0 million in upfront payments, with $10.0 million expected in Q4 2025, this is a short-term solution for a company with a history of operating losses and no commercial revenue.

Analyst Insight

Investors should monitor Cue Biopharma's cash burn rate closely and evaluate the long-term impact of the ImmunoScape collaboration beyond the initial upfront payments. Given the high risk and going concern warning, a cautious approach is warranted, focusing on future financing efforts and clinical trial progress for CUE-401 and the CUE-500 series.

Financial Highlights

debt To Equity

1.39

revenue

$2.149M

operating Margin

N/A

total Assets

$31.644M

total Debt

$18.398M

net Income

-$7.448M

eps

N/A

gross Margin

N/A

cash Position

$11.701M

revenue Growth

-35.5%

Revenue Breakdown

Key Numbers

• $7.448M — Net loss for Q3 2025 (Improved from $8.660M in Q3 2024)
• $28.187M — Net loss for nine months ended Sept 30, 2025 (Improved from $31.178M in the same period of 2024)
• $2.149M — Collaboration revenue for Q3 2025 (Decreased from $3.336M in Q3 2024)
• $4.754M — Research and development expenses for Q3 2025 (Significantly decreased from $9.381M in Q3 2024)
• $11.701M — Cash and cash equivalents as of Sept 30, 2025 (Decreased from $22.459M at Dec 31, 2024)
• $15.0M — Upfront payments from ImmunoScape agreement (Includes $5.0M received and $5.0M expected in Q4 2025)
• 77,781,743 — Common shares outstanding as of Sept 30, 2025 (Increased from 61,819,101 at Dec 31, 2024 due to equity offerings)
• $20.611M — Net cash used in operating activities for nine months ended Sept 30, 2025 (Reduced from $27.301M in the same period of 2024)

Key Players & Entities

• Cue Biopharma, Inc. (company) — registrant of the 10-Q filing
• ImmunoScape Pte. Ltd. (company) — partner in Collaboration and License Agreement
• Boehringer Ingelheim International GmbH (company) — licensee of CUE-501
• Nasdaq Capital Market (regulator) — exchange where Common Stock is registered
• CUE-401 (product) — drug product candidate in autoimmune programs
• CUE-500 series (product) — drug product candidates in autoimmune programs
• CUE-501 (product) — drug product candidate licensed to Boehringer Ingelheim
• Securities and Exchange Commission (regulator) — filing oversight body

FAQ

Risk Factors

• Substantial Cash Burn and Need for Future Financing [high — financial]: The company reported a net loss of $7.448 million for Q3 2025 and had $11.701 million in cash and cash equivalents as of September 30, 2025. This cash position has significantly decreased from $22.459 million at December 31, 2024. Continued operating losses and R&D expenses necessitate ongoing financing, posing a risk if capital cannot be secured on favorable terms.
• Dependence on Collaboration and Licensing Agreements [high — operational]: Cue Biopharma's revenue is heavily reliant on collaboration revenue, which decreased to $2.149 million in Q3 2025. The success and continuation of these partnerships, such as the new agreement with ImmunoScape Pte. Ltd., are critical for funding operations and future development. Any disruption or failure in these collaborations could severely impact financial stability.
• Significant Reduction in R&D Spending [medium — operational]: Research and development expenses decreased significantly to $4.754 million for Q3 2025 from $9.381 million in the prior year. While this improves near-term cash burn, a sustained reduction in R&D investment could impact the pace of drug development and the company's ability to advance its pipeline, potentially affecting long-term competitiveness.
• Dilution from Equity Offerings [medium — financial]: The number of common shares outstanding increased from 61,819,101 at December 31, 2024, to 77,781,743 at September 30, 2025, due to equity offerings. While these offerings provide capital, they result in dilution for existing shareholders, impacting earnings per share and ownership stakes.
• Biopharmaceutical Development Risks [high — regulatory]: As a biopharmaceutical company, Cue Biopharma faces inherent risks associated with drug development, including clinical trial failures, regulatory hurdles, and lengthy approval processes. The success of its product candidates is not guaranteed, and setbacks in development can lead to significant financial losses and reputational damage.

Industry Context

The biopharmaceutical industry is characterized by high R&D costs, long development cycles, and significant regulatory oversight. Companies like Cue Biopharma compete by developing innovative therapies, often relying on strategic partnerships and collaborations to fund development and access expertise. The sector is driven by scientific advancements, patent protection, and the potential for substantial returns upon successful drug commercialization.

Regulatory Implications

As a clinical-stage biopharmaceutical company, Cue Biopharma is subject to stringent regulations from bodies like the FDA. Successful navigation of clinical trials, manufacturing standards, and marketing approvals are critical. Any delays or failures in regulatory processes can significantly impact timelines and financial viability. The company must also comply with financial reporting regulations, as evidenced by this 10-Q filing.

What Investors Should Do

1. Monitor R&D Spending and Pipeline Progress
2. Assess Cash Runway and Future Financing Needs
3. Analyze Collaboration Agreement Terms and Performance
4. Consider Shareholder Dilution

Key Dates

• 2025-09-30: End of Q3 2025 — Reporting period for the 10-Q, showing reduced net loss but also decreased collaboration revenue and cash reserves.
• 2025-11-06: Collaboration and License Agreement with ImmunoScape Pte. Ltd. — Provides significant upfront payments ($15.0M total, $5.0M received, $5.0M expected Q4 2025), bolstering cash position and validating the company's technology.
• 2024-12-31: End of Fiscal Year 2024 — Baseline for comparison of cash position, which has significantly decreased by September 30, 2025.

Glossary

Collaboration Revenue

Revenue generated from partnerships with other companies, often involving milestone payments, research funding, or royalties related to joint development projects. (This is Cue Biopharma's primary source of revenue, and its fluctuations directly impact the company's financial performance.)

Accumulated Deficit

The cumulative net losses of a company since its inception, less any accumulated profits. It represents the total loss that has not been offset by profits. (Indicates the company has historically operated at a loss, common for early-stage biopharmaceutical firms investing heavily in R&D.)

Operating Lease Right-of-Use Asset

An asset recognized under accounting standards for leases, representing the lessee's right to use an underlying asset for the lease term. (Reflects the company's long-term commitments for facilities or equipment, impacting its balance sheet and cash flows.)

Research and Development Contract Liability

Represents obligations to perform research and development activities, often related to upfront payments received from collaborations where the services have not yet been rendered. (The significant increase in the current portion of this liability suggests new collaboration agreements or expected future R&D activities tied to existing ones.)

Year-Over-Year Comparison

Compared to the prior year's comparable periods, Cue Biopharma has reduced its net loss, indicating improved operational efficiency or cost management, with R&D expenses significantly down. However, collaboration revenue has also decreased, suggesting a shift in partnership dynamics or milestone achievements. The company's cash position has substantially weakened, necessitating a focus on the recent ImmunoScape agreement to bolster liquidity and fund future operations.

Key Financial Figures

• $0.001 — ch registered Common Stock, par value $0.001 per share CUE Nasdaq Capital Market

Filing Documents

• cue-20250930.htm (10-Q) — 1848KB
• cue-ex10_1.htm (EX-10.1) — 162KB
• cue-ex10_2.htm (EX-10.2) — 91KB
• cue-ex10_3.htm (EX-10.3) — 43KB
• cue-ex31_1.htm (EX-31.1) — 14KB
• cue-ex32_1.htm (EX-32.1) — 12KB
• img78873857_0.jpg (GRAPHIC) — 235KB
• 0001193125-25-277466.txt ( ) — 8853KB
• cue-20250930.xsd (EX-101.SCH) — 1325KB
• cue-20250930_htm.xml (XML) — 1212KB

FINANCIAL INFORMATION

PART I. FINANCIAL INFORMATION

Financial Statements (Unaudited)

Item 1. Financial Statements (Unaudited) 6 Condensed Consolidated Balance Sheets 6 Condensed Consolidated Statements of Operations and Comprehensive Loss 7 Condensed Consolidated Statements of Stockholders' Equity 8 Condensed Consolidated Statements of Cash Flows 9 Notes to the Condensed Consolidated Financial Statements (Unaudited) 10

Management's Discussion and Analysis of Financial Condition and Results of Operations

Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations 29

Quantitative and Qualitative Disclosures about Market Risk

Item 3. Quantitative and Qualitative Disclosures about Market Risk 43

Controls and Procedures

Item 4. Controls and Procedures 43

OTHER INFORMATION

PART II. OTHER INFORMATION

Legal Proceedings

Item 1. Legal Proceedings 44

Risk Factors

Item 1A. Risk Factors 44

Unregistered Sales of Equity Securities and Use of Proceeds

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 46

Defaults Upon Senior Securities

Item 3. Defaults Upon Senior Securities 46

Mine Safety Disclosures

Item 4. Mine Safety Disclosures 46

Other Information

Item 5. Other Information 46

Exhibits

Item 6. Exhibits 47 2 CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS AND INDUSTRY DATA This Quarterly Report on Form 10-Q contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, which are based on certain assumptions and describe our 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. All statements, other than statements of historical fact, contained in this Quarterly Report on Form 10-Q, including statements regarding our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans and objectives of management, are forward-looking statements. The forward-looking statements in this Quarterly Report on Form 10-Q include, among other things, statements about: the initiation, timing, progress and results of our ongoing and planned preclinical studies and any future clinical trials and our research and development programs; our estimates regarding expenses, future revenue, capital requirements and need for additional financing; our expectations regarding our ability to fund our projected operating requirements with our existing cash resources and the period in which we expect that such cash resources will enable us to fund such operating requirements; our plans to develop our drug product candidates, including our prioritization of our autoimmune programs, including CUE-401 and the CUE-500 series (excluding CUE-501, which has been licensed to Boehringer Ingelheim International GmbH); the timing of and our ability to submit applications for, and to obtain and maintain regulatory approvals for, our

Financial Sta tements

Item 1. Financial Sta tements Cue Biopharma, Inc. Condensed Consolidated Bal ance Sheets (Unaudited) (in thousands, except share and per share amounts) September 30, 2025 December 31, 2024 ASSETS Current assets: Cash and cash equivalents $ 11,701 $ 22,459 Marketable securities 6,971 — Accounts receivable 387 945 Deposits, current portion 1,747 929 Prepaid expenses and other current assets 3,114 805 Foreign withholding tax receivable 1,899 — Total current assets 25,819 25,138 Property and equipment, net 307 471 Operating lease right-of-use asset 4,602 4,370 Deposits 667 1,955 Restricted cash 153 152 Other long-term assets 96 105 Total assets $ 31,644 $ 32,191 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $ 2,348 $ 2,823 Accrued expenses 1,871 2,908 Research and development contract liability, current portion 7,816 85 Operating lease liabilities, current 2,031 3,540 Current portion of long-term debt, net 1,458 4,333 Total current liabilities 15,524 13,689 Operating lease liabilities, non-current 2,684 1,003 Other long-term payable 190 — Total liabilities $ 18,398 $ 14,692 Commitments and contingencies (Note 12) Stockholders' equity: Preferred stock, $ 0.001 par value; 10,000,000 shares authorized and 0 shares issued and outstanding at September 30, 2025 and December 31, 2024 — — Common stock, $ 0.001 par value; 300,000,000 shares authorized; 77,781,743 and 61,819,101 shares issued and outstanding at September 30, 2025 and December 31, 2024, respectively 78 62 Additional paid in capital 383,218 359,301 Accumulated other comprehensive loss 1 — Accumulated deficit ( 370,051 ) ( 341,864 ) Total stockholders' equity 13,246 17,499 Total liabilities and stockholders' equity $ 31,644 $ 32,191 The accompanying notes are an integ

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