PART I. FINANCIAL INFORMATION [Item 1. Financial Statements](index=7&type=section&id=Item%201.%20Financial%20Statements) The unaudited condensed consolidated financial statements for the period ended June 30, 2025, show an increase in cash and total assets, primarily driven by financing activities, with the company continuing to incur net losses, reporting a loss of $20.7 million for the six months ended June 30, 2025, and notes highlight substantial doubt about the company's ability to continue as a going concern due to recurring losses and the need for additional capital [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, the company's total assets increased to $40.7 million from $32.2 million at year-end 2024, primarily due to a rise in cash and cash equivalents, while total liabilities also grew to $22.5 million from $14.7 million, largely driven by an increase in research and development contract liability, and total stockholders' equity saw a slight increase to $18.2 million Condensed Consolidated Balance Sheets (in thousands) | | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Current Assets** | | | | Cash and cash equivalents | $27,492 | $22,459 | | Total current assets | $30,844 | $25,138 | | **Total assets** | **$40,707** | **$32,191** | | **Current Liabilities** | | | | Research and development contract liability, current portion | $9,579 | $85 | | Total current liabilities | $19,254 | $13,689 | | **Total liabilities** | **$22,548** | **$14,692** | | **Total stockholders' equity** | **$18,159** | **$17,499** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For the six months ended June 30, 2025, collaboration revenue decreased to $3.4 million from $4.4 million year-over-year, total operating expenses were reduced to $24.3 million from $27.4 million, primarily due to lower research and development costs, and consequently, the net loss for the six-month period narrowed to $20.7 million from $22.5 million in the prior year Condensed Consolidated Statements of Operations (in thousands) | | Three Months Ended June 30, | Six Months Ended June 30, | | :--- | :--- | :--- | | | **2025** | **2024** | **2025** | **2024** | | Collaboration revenue | $2,954 | $2,658 | $3,374 | $4,375 | | Research and development | $7,910 | $9,530 | $16,457 | $19,729 | | Total operating expenses | $11,589 | $13,041 | $24,309 | $27,426 | | Loss from operations | $(8,635) | $(10,383) | $(20,935) | $(23,051) | | **Net loss** | **$(8,482)** | **$(10,171)** | **$(20,739)** | **$(22,518)** | | Net loss per common share | $(0.09) | $(0.24) | $(0.20) | $(0.45) | [Condensed Consolidated Statements of Stockholders' Equity](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) For the six months ended June 30, 2025, stockholders' equity increased from $17.5 million to $18.2 million, driven by the issuance of common stock, warrants, and pre-funded warrants, which provided net proceeds of $18.8 million, offset by a net loss of $20.7 million and balanced by stock-based compensation - During the first six months of 2025, the company raised approximately **$18.8 million** through the issuance of common stock, warrants, and pre-funded warrants, net of costs[23](index=23&type=chunk) - The accumulated deficit increased by **$20.7 million** during the first half of 2025, reaching **$362.6 million** due to continued net losses[23](index=23&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2025, net cash used in operating activities was $11.6 million, a significant improvement from $19.8 million in the same period of 2024, while net cash provided by financing activities was $16.8 million, primarily from stock offerings, leading to a net increase in cash of $5.0 million, compared to a net decrease of $18.5 million in the prior year period Summary of Cash Flows (in thousands) | | Six Months Ended June 30, | | :--- | :--- | :--- | | | **2025** | **2024** | | Net cash used in operating activities | $(11,587) | $(19,774) | | Net cash used in investing activities | $(177) | $(65) | | Net cash provided by financing activities | $16,798 | $1,354 | | **Net increase (decrease) in cash** | **$5,034** | **$(18,485)** | | Cash at end of period | $27,645 | $30,180 | [Notes to the Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements) The notes detail significant accounting policies and provide context for the financial statements, including the company's conclusion that there is substantial doubt about its ability to continue as a going concern, details of recent financing activities including an $18.0 million offering in April 2025, and information on collaboration agreements, notably a new agreement with Boehringer Ingelheim (BI) which included a $10.1 million upfront payment - The company's recurring losses and negative cash flows from operations raise substantial doubt about its ability to continue as a going concern within one year[31](index=31&type=chunk) - In April 2025, the company completed an underwritten public offering, receiving net proceeds of **$18.0 million** from the sale of shares and warrants[38](index=38&type=chunk) - The company entered into a collaboration and license agreement with Boehringer Ingelheim (BI) in April 2025, receiving an upfront payment of **$10.1 million** (net of withholding taxes) and recognizing **$2.9 million** in revenue for the quarter[123](index=123&type=chunk)[125](index=125&type=chunk)[127](index=127&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=36&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's strategic focus on its autoimmune disease pipeline (CUE-401 and CUE-500 series) while seeking partners for its oncology assets (CUE-100 series), with the analysis of financial results showing a decrease in net loss driven by lower R&D spending, and the company's liquidity position detailed, with existing cash expected to fund operations into the second quarter of 2026, which raises substantial doubt about its ability to continue as a going concern without additional financing [Overview and Plan of Operation](index=36&type=section&id=Overview%20and%20Plan%20of%20Operation) Cue Biopharma is a clinical-stage company developing therapeutics for autoimmune disease and cancer using its Immuno-STAT® platform, strategically prioritizing its autoimmune programs, including CUE-401 and the CUE-500 series, while seeking collaborations for its CUE-100 series oncology assets, with a plan to file an IND for CUE-401 in Q2 2026 and leverage partnerships, such as the recent agreement with Boehringer Ingelheim for CUE-501 - The company is prioritizing its autoimmune programs, **CUE-401** and the **CUE-500 series**, over its **CUE-100 series** oncology programs[8](index=8&type=chunk)[164](index=164&type=chunk) - Cue Biopharma plans to file an Investigational New Drug (IND) application for its autoimmune candidate **CUE-401** in the second quarter of 2026[157](index=157&type=chunk)[166](index=166&type=chunk) - The company is actively seeking collaborations for its oncology assets, **CUE-101** and **CUE-102**, to fund the advancement of its autoimmune pipeline[168](index=168&type=chunk) [Results of Operations](index=48&type=section&id=Results%20of%20Operations) For the six months ended June 30, 2025, collaboration revenue decreased by $1.0 million year-over-year due to the timing of activities under different collaboration agreements, research and development expenses fell by $3.3 million, primarily from reduced clinical trial costs for the CUE-100 series, and general and administrative expenses remained relatively flat, resulting in a lower net loss of $20.7 million compared to $22.5 million in the prior-year period Comparison of Results of Operations (in thousands) | | Six Months Ended June 30, | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | | **2025** | **2024** | | | | Collaboration revenue | $3,374 | $4,375 | $(1,001) | -22.9% | | Research and development | $16,457 | $19,729 | $(3,272) | -16.6% | | General and administrative | $7,852 | $7,697 | $155 | +2.0% | | **Net loss** | **$(20,739)** | **$(22,518)** | **$1,779** | **-7.9%** | - The decrease in R&D expenses was primarily due to reduced clinical trial costs for the **CUE-100 series** as activities shifted to patient survival monitoring[207](index=207&type=chunk) [Liquidity and Capital Resources](index=49&type=section&id=Liquidity%20and%20Capital%20Resources) The company's primary sources of liquidity are equity offerings and collaboration payments, with cash and cash equivalents of $27.5 million as of June 30, 2025, which management believes will support operations into Q2 2026, but this runway of less than 12 months raises substantial doubt about the company's ability to continue as a going concern, necessitating additional capital raising, with recent financing including an $18.0 million net proceeds from an offering in April 2025 and sales under an ATM program - The company's existing cash and cash equivalents of **$27.5 million** as of June 30, 2025, are expected to fund operations into the second quarter of 2026[16](index=16&type=chunk)[225](index=225&type=chunk) - The company's limited cash runway raises substantial doubt about its ability to continue as a going concern, necessitating additional capital raising[219](index=219&type=chunk)[225](index=225&type=chunk) - In April 2025, the company raised approximately **$18.0 million** in net proceeds from an underwritten public offering of common stock and warrants[218](index=218&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=55&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a smaller reporting company, Cue Biopharma is not required to provide the information for this item - The company is not required to provide quantitative and qualitative disclosures about market risk as it qualifies as a smaller reporting company[231](index=231&type=chunk) [Item 4. Controls and Procedures](index=55&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the principal executive and financial officers, evaluated the company's disclosure controls and procedures and concluded they were effective as of June 30, 2025, with no material changes in internal control over financial reporting during the quarter - The company's principal executive officer and principal financial officer concluded that disclosure controls and procedures were effective as of June 30, 2025[233](index=233&type=chunk) - There were no changes in internal control over financial reporting during the quarter that have materially affected, or are reasonably likely to materially affect, these controls[235](index=235&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=56&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that it is not currently a party to any material legal proceedings - As of the reporting date, the company is not involved in any material legal proceedings[237](index=237&type=chunk) [Item 1A. Risk Factors](index=56&type=section&id=Item%201A.%20Risk%20Factors) This section highlights significant risks to the business, with the primary risk being the substantial doubt regarding the company's ability to continue as a going concern due to recurring losses and the need for additional capital, and other key risks including potential delisting from Nasdaq for failing to meet the minimum bid price requirement, and uncertainties related to U.S. trade policy and changes in tax laws - The company's recurring losses and need for additional capital raise substantial doubt about its ability to continue as a going concern[239](index=239&type=chunk) - On May 12, 2025, the company received a deficiency notice from Nasdaq for failing to maintain a minimum bid price of **$1.00** per share, posing a risk of delisting[247](index=247&type=chunk) - Uncertainty surrounding U.S. trade policy, including tariffs, could negatively impact material costs and supply chains[241](index=241&type=chunk)[244](index=244&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=59&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities during the period - None[252](index=252&type=chunk) [Item 5. Other Information](index=59&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement during the quarterly period - No directors or officers adopted or terminated a Rule 10b5-1 trading arrangement during the quarter[255](index=255&type=chunk) [Item 6. Exhibits](index=60&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Quarterly Report on Form 10-Q, including certifications and amendments to agreements - The report includes a list of exhibits filed, such as the Second Amendment to the License Agreement with MIL 40G, LLC, and various required certifications[257](index=257&type=chunk)

[Business Highlights](index=1&type=section&id=Business%20Highlights) Cue Biopharma achieved positive clinical data for CUE-101, advanced its autoimmune pipeline, secured a $12 million collaboration, and raised $20 million - Reported encouraging clinical data from the Phase 1b trial of CUE-101 for HPV+ HNSCC, with a new complete response and a confirmed **50% overall response rate (ORR)**. The 12-month overall survival was **88%** and median overall survival (mOS) reached **32 months**[3](index=3&type=chunk)[7](index=7&type=chunk) - Received positive FDA feedback on the Pre-IND Briefing Document for CUE-401, supporting the planned IND submission for treating autoimmune diseases[5](index=5&type=chunk)[6](index=6&type=chunk) - Announced a strategic research collaboration and license agreement with Boehringer Ingelheim to develop CUE-501 for autoimmune diseases, which includes a **$12 million upfront payment** and up to approximately **$345 million in potential milestone payments**[5](index=5&type=chunk)[6](index=6&type=chunk) - Successfully raised approximately **$20 million** through a public offering to support operations[5](index=5&type=chunk)[6](index=6&type=chunk) [Financial Performance](index=2&type=section&id=Financial%20Performance) Collaboration revenue increased to **$3.0 million**, operating expenses decreased, leading to a reduced net loss of **$8.5 million**, and cash improved to **$27.5 million** [Second Quarter 2025 Financial Results](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Results) Q2 2025 collaboration revenue rose to **$3.0 million**, R&D expenses decreased to **$7.9 million**, and G&A expenses slightly increased to **$3.7 million** Q2 2025 vs Q2 2024 Financial Summary | Financial Metric | Q2 2025 | Q2 2024 | Change Driver | | :--- | :--- | :--- | :--- | | Collaboration Revenue | $3.0 million | $2.7 million | Timing of revenue from BI collaboration | | R&D Expenses | $7.9 million | $9.5 million | Decreases in clinical trials costs and employee compensation | | G&A Expenses | $3.7 million | $3.5 million | Increase in professional fees | [Condensed Consolidated Statements of Operations](index=3&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Net loss for Q2 2025 narrowed to **$8.5 million** (or **$0.09** per share), and for the six months, it improved to **$20.7 million** Statement of Operations Highlights (Three Months Ended June 30, in thousands) | Metric | 2025 | 2024 | | :--- | :--- | :--- | | Collaboration revenue | $2,954 | $2,658 | | Total operating expenses | $11,589 | $13,041 | | Loss from operations | $(8,635) | $(10,383) | | Net loss | $(8,482) | $(10,171) | | Net loss per share | $(0.09) | $(0.20) | Statement of Operations Highlights (Six Months Ended June 30, in thousands) | Metric | 2025 | 2024 | | :--- | :--- | :--- | | Collaboration revenue | $3,374 | $4,375 | | Total operating expenses | $24,309 | $27,426 | | Loss from operations | $(20,935) | $(23,051) | | Net loss | $(20,739) | $(22,518) | | Net loss per share | $(0.24) | $(0.45) | [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Cash and cash equivalents increased to **$27.5 million**, total assets grew to **$40.7 million**, and stockholders' equity remained stable at **$18.2 million** Balance Sheet Summary (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $27,492 | $22,459 | | Total assets | $40,707 | $32,191 | | Liabilities | $22,548 | $14,692 | | Stockholders' equity | $18,159 | $17,499 | [Corporate Information and Forward-Looking Statements](index=3&type=section&id=Corporate%20Information%20and%20Forward-Looking%20Statements) Cue Biopharma, a clinical-stage biopharmaceutical company, develops injectable biologics using its Immuno-STAT® platform, with forward-looking statements subject to various risks [About Cue Biopharma](index=3&type=section&id=About%20Cue%20Biopharma) Cue Biopharma is a clinical-stage company developing injectable biologics using its proprietary Immuno-STAT® platform to selectively modulate disease-specific T cells - The company's core technology is the proprietary **Immuno-STAT® (Selective Targeting and Alteration of T cells) platform**[14](index=14&type=chunk) - The company's focus is on developing injectable biologics to selectively modulate disease-specific T cells for treating cancer and autoimmune diseases[14](index=14&type=chunk) [Forward-Looking Statements](index=4&type=section&id=Forward-Looking%20Statements) This section details risks and uncertainties for forward-looking statements, including CUE-101 potential, IND submissions, and milestone payments, citing operational and financial challenges - Forward-looking statements in the release cover the potential of CUE-101, plans for an IND submission for CUE-401, and potential future milestone payments[16](index=16&type=chunk) - Key risks identified include a limited operating history, history of losses, ability to obtain adequate financing, potential for negative clinical trial results, and securing FDA approvals[16](index=16&type=chunk)[17](index=17&type=chunk)

Core Viewpoint - Cue Biopharma, Inc. is advancing its clinical-stage drug candidate CUE-101, which shows promising results in treating recurrent metastatic HPV+ head and neck squamous cell carcinoma (HNSCC) in combination with pembrolizumab, indicating a potential breakthrough in therapeutic approaches for autoimmune diseases and cancer [1][2][4]. Clinical Update - An additional complete response (CR) was reported in a patient with recurrent metastatic HPV+ HNSCC treated with CUE-101 and pembrolizumab, demonstrating significant tumor reductions and a durable stable disease for nearly two years [2]. - The overall response rate (ORR) in patients with a combined positive score (CPS) ≥1 is 50%, including a 50% ORR in patients with low CPS (1-19) [8]. - The 12-month overall survival rate is 88%, with a median overall survival (mOS) of 32 months, compared to 57% and 12.3 months, respectively, in the historical KEYNOTE-048 trial [9]. Drug Mechanism and Development - CUE-101 is designed to activate and expand HPV16 tumor-specific T cells by presenting two signals: the HPV E7 protein for selectivity and an engineered IL-2 variant to stimulate T cell activity [5]. - The drug is currently being evaluated in a fully enrolled Phase 1 open-label, dose escalation and expansion study for HPV16+ driven recurrent/metastatic HNSCC as both a monotherapy and in combination with pembrolizumab [5]. Company Overview - Cue Biopharma is focused on developing a novel class of injectable biologics to selectively engage and modulate disease-specific T cells, utilizing its proprietary Immuno-STAT platform [6]. - The company is headquartered in Boston, Massachusetts, and is led by a management team with extensive expertise in immunology and immuno-oncology [7].

Core Insights - Cue Biopharma, Inc. has reported promising results from its Phase 1 trial of CUE-101, showing an overall response rate (ORR) of 50% in treatment-naïve patients with recurrent metastatic HPV+ head and neck squamous cell carcinoma (HNSCC) [3] - The 12-month overall survival (OS) rate is 88%, indicating a significant reduction in the risk of death compared to historical data [3] - The median overall survival (mOS) is currently estimated at 32 months [3] Company Overview - Cue Biopharma is a clinical-stage biopharmaceutical company focused on developing a novel class of therapeutic biologics aimed at selectively engaging and modulating disease-specific T cells for treating autoimmune diseases and cancer [2][7] - The company's proprietary platform, Immuno-STAT™, is designed to harness the body's immune system without the adverse effects associated with broad systemic immune modulation [7] Product Details - CUE-101 is the most advanced clinical stage drug candidate from the CUE-100 series, designed to activate and expand HPV16 tumor-specific T cells [6] - The mechanism of action involves presenting two signals to T cells: one from the HPV E7 protein and another from an engineered IL-2 variant [6] - The CUE-100 series consists of Fc-fusion biologics that selectively target and activate tumor-specific T cells while minimizing systemic activation and potential toxicities [5] Clinical Trial Insights - The Phase 1 trial of CUE-101 is fully enrolled and evaluates the drug as a monotherapy and in combination with pembrolizumab (KEYTRUDA) for HPV16+ driven recurrent/metastatic HNSCC [6] - The trial results indicate that CUE-101 may represent a breakthrough therapeutic approach for patients battling HNSCC, as stated by the company's chief medical officer [4]

Core Insights - Cue Biopharma, Inc. has received positive Pre-IND feedback from the FDA regarding its lead autoimmune asset, CUE-401, a first-in-class bispecific molecule designed to induce and expand regulatory T cells (Tregs) in vivo [1][2] - CUE-401 utilizes the combined activities of transforming growth factor beta (TGF-β) and a modified variant of interleukin 2 (IL-2) to potentially provide durable immune rebalance and tolerance for various autoimmune diseases [2][4] Company Overview - Cue Biopharma is a clinical-stage biopharmaceutical company focused on developing a novel class of therapeutic biologics that selectively engage and modulate disease-specific T cells for autoimmune disease treatment [1][8] - The company’s proprietary platform, Immuno-STAT™, aims to harness the body's intrinsic immune system without the adverse effects of broad systemic immune modulation [8] Product Details - CUE-401 is engineered to enhance the Treg induction capacity of TGF-β combined with IL-2 signaling, which is believed to improve the quality and stability of Tregs [5][6] - The design of CUE-401 allows for "conditional binding," which minimizes off-target activity and simplifies manufacturing processes [6] Mechanism of Action - CUE-401 acts as a master switch to convert autoreactive effector T cells into stable, induced T-regulatory cells (iTregs), establishing a 'tolerance positive feedback loop' that increases nonspecific Treg populations while reducing autoreactive T cells [7]

Summary of CUE Biopharma's Conference Call on May 15, 2025 Company Overview - **Company**: CUE Biopharma - **Focus**: Development of novel biologics for autoimmune and inflammatory diseases, particularly through the Q401 platform Key Points and Arguments 1. Introduction of Q401 - Q401 is highlighted as a first-in-class bispecific biologic targeting TGF beta and IL-2 to induce regulatory T cells (Tregs) for treating autoimmune diseases [4][15][20] - The mechanism of action involves transforming autoreactive effector T cells into Tregs, thereby restoring immune balance [14][21] 2. Clinical Potential - Q401 is positioned as a potential new standard of care for autoimmune and inflammatory diseases, addressing significant unmet medical needs [6][7] - The data presented supports the premise that Q401 can lead to durable immune tolerance and long-term clinical benefits [15][20] 3. Collaboration and Validation - A collaboration with Boehringer Ingelheim for the development of Q501, targeting B cells in autoimmune diseases, is noted as a validation of CUE's biologics platform [7][11] - The partnership is expected to provide non-dilutive capital while retaining rights for other applications outside B cell targeting [11] 4. Oncology Programs - Updates on oncology programs indicate promising clinical data, particularly with Q101 in treating HPV-positive head and neck squamous cell carcinoma, showing a median overall survival of over 20 months compared to historical data of 8 months [9][10] 5. Mechanistic Insights - The unique design of Q401 allows for simultaneous signaling of TGF beta and IL-2, which is crucial for Treg induction [18][21] - Challenges with traditional TGF beta and IL-2 therapies, such as off-target toxicity and short half-lives, are addressed by Q401's innovative engineering [16][17] 6. Preclinical Data - Preclinical studies demonstrate that Q401 effectively expands both natural and induced Tregs while reducing effector T cells in various autoimmune models [25][29] - The treatment shows potential for long-lasting immune regulation and suppression of autoimmune responses [36][38] 7. Expert Perspectives - Contributions from key opinion leaders, including Dr. Rich DiPaolo and Dr. Andy Cope, emphasize the transformative potential of Q401 in restoring immune homeostasis and addressing chronic inflammatory diseases [49][51] - Dr. Cope highlights the need for therapies that induce tolerance and maintain immune balance, which Q401 aims to achieve [55][61] 8. Future Directions - The company is assessing strategic pathways for Q401's clinical development, considering various autoimmune indications such as IBD, multiple sclerosis, and transplantation [72] - Plans for IND filing and further exploration of the Q500 series for additional therapeutic targets are also discussed [72] Additional Important Content - The call included a Q&A session addressing inquiries about the status of various programs, with a focus on the potential for Q401 in clinical settings [65][66] - Emphasis on the need for innovative therapies that can provide durable immune modulation rather than just symptomatic relief [56][60] This summary encapsulates the critical insights and developments shared during the conference call, reflecting CUE Biopharma's strategic focus on advancing its biologics platform for autoimmune and inflammatory diseases.

Company Performance - Cue Biopharma reported a quarterly loss of $0.17 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.14, representing an earnings surprise of -21.43% [1] - The company posted revenues of $0.42 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 78.95%, compared to revenues of $1.72 million a year ago [2] - Over the last four quarters, Cue Biopharma has surpassed consensus EPS estimates three times and topped consensus revenue estimates two times [2] Stock Movement and Outlook - Cue Biopharma shares have declined approximately 28.5% since the beginning of the year, while the S&P 500 has only declined by 3.8% [3] - The company's earnings outlook is crucial for investors, as it includes current consensus earnings expectations for upcoming quarters and any recent changes to these expectations [4] - The current consensus EPS estimate for the coming quarter is -$0.14 on $2 million in revenues, and -$0.58 on $8.36 million in revenues for the current fiscal year [7] Industry Context - The Medical - Biomedical and Genetics industry, to which Cue Biopharma belongs, is currently ranked in the top 34% of over 250 Zacks industries, indicating a favorable outlook [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5] - The Zacks Rank for Cue Biopharma is currently 2 (Buy), suggesting that the shares are expected to outperform the market in the near future [6]

Core Insights - Cue Biopharma announced a strategic collaboration and license agreement with Boehringer Ingelheim for CUE-501, which includes an upfront payment of $12 million and potential milestone payments of approximately $345 million [1] - The company raised gross proceeds of around $20 million in a follow-on capital raise [1] - Cue Biopharma regained worldwide rights for its lead autoimmune program, CUE-401, which has the potential to become a new standard of care for autoimmune and inflammatory diseases [1] Financial Performance - For the first quarter of 2025, Cue Biopharma reported revenue of $0.4 million, a decrease from $1.7 million in the same period of 2024, primarily due to the termination of the agreement with Ono Pharmaceutical [5] - Research and development expenses decreased to $8.5 million in Q1 2025 from $10.2 million in Q1 2024, attributed to lower clinical trial costs and employee compensation [6] - General and administrative expenses remained stable at $4.2 million for both Q1 2025 and Q1 2024 [6] Cash Position - As of March 31, 2025, the company had $13.1 million in cash and cash equivalents [7] - In April 2025, Cue Biopharma received approximately $18 million in net proceeds from an underwritten public offering [7] Upcoming Events - A virtual event is scheduled for May 15, 2025, featuring two key opinion leaders in immunology, which will highlight new preclinical data for CUE-401 and updates on the CUE-500 program [3][4]

[PART I. FINANCIAL INFORMATION](index=7&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Financial Statements (Unaudited)](index=7&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents the unaudited condensed consolidated financial statements, highlighting recurring losses and going concern issues [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) 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](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) 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](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) 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](index=22&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) 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)](index=11&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements%20(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](index=29&type=chunk)[30](index=30&type=chunk) - 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](index=29&type=chunk)[130](index=130&type=chunk)[137](index=137&type=chunk) - 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](index=113&type=chunk)[115](index=115&type=chunk)[111](index=111&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A)](index=35&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) 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](index=9&type=chunk)[149](index=149&type=chunk)[152](index=152&type=chunk) - 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](index=153&type=chunk)[204](index=204&type=chunk)[221](index=221&type=chunk) - 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](index=199&type=chunk)[204](index=204&type=chunk) 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](index=53&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) 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](index=213&type=chunk) [Controls and Procedures](index=53&type=section&id=Item%204.%20Controls%20and%20Procedures) 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](index=215&type=chunk) - 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](index=217&type=chunk) [PART II. OTHER INFORMATION](index=54&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=54&type=section&id=Item%201.%20Legal%20Proceedings) 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](index=219&type=chunk) [Risk Factors](index=54&type=section&id=Item%201A.%20Risk%20Factors) 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](index=221&type=chunk)[222](index=222&type=chunk) - 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](index=227&type=chunk)[228](index=228&type=chunk) - Changes in U.S. trade policy, including recently imposed tariffs, could negatively impact the company's costs, production processes, and supply chain[223](index=223&type=chunk)[226](index=226&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=57&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no unregistered sales of equity securities during the period - None reported for the period[232](index=232&type=chunk) [Defaults Upon Senior Securities](index=57&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities - None reported[233](index=233&type=chunk) [Mine Safety Disclosures](index=57&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[234](index=234&type=chunk) [Other Information](index=57&type=section&id=Item%205.%20Other%20Information) 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](index=235&type=chunk) - The company has an initial 180-day period, until November 10, 2025, to regain compliance with Nasdaq's minimum bid price rule[236](index=236&type=chunk) - No directors or officers adopted or terminated a Rule 10b5-1 trading arrangement during the quarterly period[240](index=240&type=chunk) [Exhibits](index=58&type=section&id=Item%206.%20Exhibits) 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](index=242&type=chunk)

Core Insights - Cue Biopharma is hosting a virtual investor event on May 15, 2025, to discuss its innovative biologics platform aimed at treating autoimmune diseases and cancer [1][2] - The event will feature key opinion leaders Richard DiPaolo, PhD, and Andrew Cope, MD, PhD, who will provide insights into the company's differentiated biologics platform and its clinical trials [2][3] Company Overview - Cue Biopharma is a clinical-stage biopharmaceutical company focused on developing a novel class of therapeutic biologics that selectively engage and modulate disease-specific T cells [1][8] - The company's proprietary platform, Immuno-STAT™, is designed to harness the body's immune potential without the adverse effects of broad systemic immune modulation [8][9] Clinical Programs - The event will include a review of the CUE-400 series, highlighting new preclinical proof-of-concept data for lead candidate CUE-401, which aims to transform the standard of care for autoimmune diseases and inflammation [3] - Updates will also be provided on the CUE-500 program, including CUE-501, which has been partnered with Boehringer Ingelheim to leverage anti-viral killer T cells for autoimmune diseases and cancer [3] Expert Contributions - Richard DiPaolo, PhD, is a leading expert in inflammation and immune regulation, with significant contributions to the understanding of regulatory T cells in autoimmunity [5] - Andrew Cope, MD, PhD, has extensive experience in rheumatology and is focused on chronic inflammatory diseases, including rheumatoid arthritis [6][7]