Cue Biopharma(CUE) - 2025 Q1 - Quarterly Report

PART I. FINANCIAL INFORMATION Financial Statements (Unaudited) This section presents the unaudited condensed consolidated financial statements, highlighting recurring losses and going concern issues Condensed Consolidated Balance Sheets The balance sheet shows a decrease in total assets and stockholders' equity, while total liabilities increased Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $13,136 | $22,459 | | Total current assets | $15,931 | $25,138 | | Total assets | $22,254 | $32,191 | | Liabilities & Equity | | | | Total current liabilities | $15,498 | $13,689 | | Total liabilities | $15,674 | $14,692 | | Total stockholders' equity | $6,580 | $17,499 | Condensed Consolidated Statements of Operations and Comprehensive Loss The company reported a net loss of $12.3 million for Q1 2025, with decreased collaboration revenue and R&D expenses Statement of Operations Highlights (in thousands) | Account | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Collaboration revenue | $421 | $1,717 | | Research and development | $8,547 | $10,199 | | General and administrative | $4,173 | $4,186 | | Loss from operations | $(12,299) | $(12,668) | | Net loss | $(12,257) | $(12,347) | | Net loss per share | $(0.17) | $(0.25) | Condensed Consolidated Statements of Stockholders' Equity Stockholders' equity significantly decreased due to the quarterly net loss, partially offset by stock-based compensation - Total stockholders' equity fell to $6,580 thousand as of March 31, 2025, down from $17,499 thousand at the end of 2024, mainly due to the quarterly net loss of $12,257 thousand[22] Condensed Consolidated Statements of Cash Flows Net cash used in operating activities improved in Q1 2025, but financing activities resulted in a cash outflow Cash Flow Summary (in thousands) | Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(8,172) | $(9,784) | | Net cash used in investing activities | $(150) | $(55) | | Net cash (used in) provided by financing activities | $(1,000) | $2,354 | | Net decrease in cash | $(9,322) | $(7,485) | Notes to the Condensed Consolidated Financial Statements (Unaudited) The notes detail accounting policies, 'going concern' status, collaboration agreements, and recent financing events - The company's history of losses and negative cash flows raises substantial doubt about its ability to continue as a going concern within one year from the financial statement issuance date[29][30] - In April 2025, the company received approximately $18.0 million in net proceeds from a public offering and a $12.0 million upfront payment from a new collaboration and license agreement with Boehringer Ingelheim (BI)[29][130][137] - The collaboration agreement with Ono was terminated in March 2025. For Q1 2025, the company recognized $0.4 million in revenue from this agreement. The LG Chem agreement generated no revenue in Q1 2025[113][115][111] Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A) Management discusses financial condition, operations, and liquidity, emphasizing 'going concern' and future funding needs - The company is strategically prioritizing its autoimmune programs, including CUE-401 and the CUE-500 series, while seeking partnerships to advance its CUE-100 series oncology programs[9][149][152] - Management explicitly states that recurring losses and future funding needs raise substantial doubt about the company's ability to continue as a going concern[153][204][221] - Existing cash, combined with approximately $18.0 million from an April 2025 offering and a $12.0 million upfront payment from the BI collaboration, is expected to fund operations into the second quarter of 2026[199][204] Q1 2025 vs Q1 2024 Operational Changes (in millions) | Metric | Q1 2025 | Q1 2024 | Change | Reason | | :--- | :--- | :--- | :--- | :--- | | Collaboration Revenue | $0.4 | $1.7 | $(1.3) | Termination of Ono agreement | | R&D Expenses | $8.5 | $10.2 | $(1.7) | Decreased clinical trial costs for CUE-101/102 | Quantitative and Qualitative Disclosures about Market Risk As a smaller reporting company, Cue Biopharma is not required to provide market risk disclosures - As a smaller reporting company, Cue Biopharma is not required to provide quantitative and qualitative disclosures about market risk[213] Controls and Procedures Management concluded that disclosure controls and procedures were effective, with no material changes to internal controls - Management concluded that the company's disclosure controls and procedures were effective as of March 31, 2025[215] - There were no changes in internal control over financial reporting during the quarter ended March 31, 2025, that have materially affected, or are reasonably likely to materially affect, internal controls[217] PART II. OTHER INFORMATION Legal Proceedings The company is not currently a party to any material legal proceedings - As of the report date, the company is not a party to any material legal proceedings[219] Risk Factors This section highlights key business risks, including going concern, Nasdaq delisting, and trade policy impacts - The company's recurring losses and need for substantial additional capital raise substantial doubt about its ability to continue as a going concern[221][222] - On May 12, 2025, the company received a deficiency letter from Nasdaq for failing to maintain a minimum bid price of $1.00 per share. It has an initial 180-day period (expiring November 10, 2025) to regain compliance[227][228] - Changes in U.S. trade policy, including recently imposed tariffs, could negatively impact the company's costs, production processes, and supply chain[223][226] Unregistered Sales of Equity Securities and Use of Proceeds The company reports no unregistered sales of equity securities during the period - None reported for the period[232] Defaults Upon Senior Securities The company reports no defaults upon senior securities - None reported[233] Mine Safety Disclosures This item is not applicable to the company - Not applicable[234] Other Information This section discloses a Nasdaq minimum bid price deficiency and no Rule 10b5-1 trading arrangement changes - On May 12, 2025, the company received a Nasdaq deficiency notice because its common stock had closed below the $1.00 minimum bid price for 30 consecutive business days[235] - The company has an initial 180-day period, until November 10, 2025, to regain compliance with Nasdaq's minimum bid price rule[236] - No directors or officers adopted or terminated a Rule 10b5-1 trading arrangement during the quarterly period[240] Exhibits This section lists the exhibits filed with the 10-Q report, including collaboration agreements and certifications - Key exhibits filed include the Collaboration and License Agreement with Boehringer Ingelheim International GmbH dated April 10, 2025, and an amendment to the license agreement with Albert Einstein College of Medicine from the same date[242]