Core Insights - Cue Biopharma and ImmunoScape have entered a collaboration to develop a novel in vivo cell therapy for solid tumors, utilizing a Seed-and-Boost immunotherapy approach that combines Cue's CUE-100 series with ImmunoScape's proprietary TCRs [1][5][6] Collaboration Details - The collaboration includes an upfront payment of $15 million, with $10 million due in Q4 2025 and $5 million in November 2026, along with a 40% equity stake in ImmunoScape and potential high-single-digit royalty payments on net sales [7] Therapeutic Approach - The Seed-and-Boost approach involves administering a minimal starting dose of ImmunoScape's tumor-specific TCR-Ts (Seed) followed by Cue Biopharma's TCR matched IL-2 Immuno-STAT molecules (Boost), designed to enhance T cell activation while minimizing systemic immune activation [2][6] - This method aims to simplify manufacturing and improve clinical efficacy, tolerability, and quality of life for patients [2][6] Clinical Data and Potential - The CUE-100 series has shown clinical activity in several metastatic cancers with reduced toxicities compared to traditional IL-2 therapies, indicating a promising future for this novel immunotherapy [3][8] - Preclinical data supports the potential of the Seed-and-Boost approach to provide durable anti-tumor effects in solid tumors, with IND-enabling studies expected for submission in 2027 [6][4] Company Background - Cue Biopharma focuses on developing therapeutic biologics to engage and modulate disease-specific T cells, while ImmunoScape specializes in next-generation TCR-based therapies in oncology [1][9][10]

Core Insights - Cue Biopharma has appointed Usman "Oz" Azam, M.D., as the new President and CEO effective September 29, 2025, transitioning Daniel Passeri to a Strategic Advisor role [1][5][4] - The leadership change aims to enhance the company's focus on autoimmune diseases, particularly advancing the first-in-class tolerogenic drug candidate CUE-401 [2][5] Leadership Transition - Daniel Passeri emphasized that the transition is a strategic step forward for the company's development, particularly in autoimmune disease [2] - Dr. Azam brings over 25 years of experience in drug discovery and development, having held leadership roles in various biopharmaceutical companies [2][3] - The board of Cue Biopharma expressed confidence in Dr. Azam's ability to drive the company's growth and thanked Passeri for his leadership [3][4] Focus on Autoimmune Disease - Cue Biopharma is prioritizing the development of CUE-401, which is designed to restore immune homeostasis and tolerance, potentially disrupting the standard of care in autoimmune diseases [3][6] - CUE-401 is characterized as a bifunctional molecule that combines a TGF-beta breathing-mask moiety with a clinically validated interleukin (IL-2) mutein [6] Company Overview - Cue Biopharma is a clinical-stage biopharmaceutical company focused on developing a novel class of injectable biologics to engage and modulate disease-specific T cells [5][6] - The company's proprietary platform, Immuno-STAT®, aims to harness the immune system's potential without broad systemic immune modulation [6][7]

Summary of Cue Biopharma Conference Call Company Overview - Cue Biopharma is based on a protein engineering platform developed from the Albert Einstein School of Medicine, focusing on designing molecules that interact specifically with T cells and lymphocytes [3][4][5] - The company has developed several bioprotein assets, including CUE-401 and CUE-501, targeting autoimmune diseases and oncology [4][36] Key Points on CUE-401 - CUE-401 is engineered to foster TGF-β binding signaling along with IL-2, essential for maintaining regulatory T cells (Tregs) and immune balance [10][19] - The mechanism of action involves conditional binding, requiring both TGF-β and IL-2 to activate targets, which enhances safety profiles compared to traditional therapies [12][13][34] - Preclinical data shows significant proliferation of Tregs, with a notable increase in induced regulatory T cells (IT-regs) from T effector cells [18][20] - In a graft-versus-host disease model, 100% of treated animals survived longer than control groups, demonstrating the potential for long-term immune tolerance [21][22] - The company plans to file an IND for CUE-401 in June 2026, with ongoing GLP toxicology studies [24][23] Development Strategy and Market Potential - Cue Biopharma aims to target multiple autoimmune diseases, with atopic dermatitis as a primary indication for initial trials [27][35] - The company believes that CUE-401 will not require chronic dosing, establishing durable Treg populations to manage diseases [26][34] - The broader application of CUE-401 is anticipated across various autoimmune diseases, including ulcerative colitis and rheumatoid arthritis [35] CUE-501 and Partnership with Boehringer Ingelheim - CUE-501 targets B cell depletion and has been partnered with Boehringer Ingelheim, focusing on differentiating from existing bispecific therapies [39][41] - The partnership includes a $12 million upfront payment and ongoing preclinical studies to define lead candidates for IND filing [45] - The preclinical data indicates equivalent B cell killing efficacy compared to bispecifics without the associated cytokine release, highlighting a favorable safety profile [42][43] Financial Overview - Cue Biopharma ended the last quarter with $28 million in cash, with an annual burn rate of approximately $25 to $28 million [51] - The company anticipates strategic partnerships and milestone payments to enhance its financial position [51] Market Dynamics and Competitive Landscape - The company is positioned to capture the pediatric market for acute graft-versus-host disease, with a significant opportunity in the adult market as well [64][68] - The competitive landscape includes existing therapies like Jakafi, which has limitations in pediatric applications and efficacy in severe cases [79][82] - Cue Biopharma's approach is expected to establish itself as a first-line therapy in children and potentially in adults with severe disease [80][82] Regulatory Engagement - Positive feedback was received from the FDA regarding the T-reg induction mechanism, with guidance towards earlier intervention in treatment protocols [22][90] - The company is aligning its clinical strategy with regulatory expectations to maximize market entry and patient impact [91]

Core Insights - Cue Biopharma, Inc. is participating in the Cantor Global Healthcare Conference from September 3-5, 2025, to discuss advancements in its Immuno-STAT platform and the development of its lead autoimmune asset, CUE-401 [1][2]. Company Overview - Cue Biopharma is a clinical-stage biopharmaceutical company focused on developing a novel class of injectable biologics that selectively engage and modulate disease-specific T cells within the patient's body [4]. - The company's proprietary platform, Immuno-STAT (Selective Targeting and Alteration of T cells), aims to utilize the body's intrinsic immune system for therapeutic purposes while minimizing adverse effects associated with broad systemic immune modulation [4]. Presentation Details - The fireside chat at the Cantor Global Healthcare Conference is scheduled for September 5, 2025, from 8:00 a.m. to 8:30 a.m. EDT, presented by CEO Daniel Passeri [3]. - A live and archived webcast of the presentation will be available on the company's website for 30 days [3].

Core Viewpoint - Cue Biopharma has initiated a Phase 1b trial for CUE-102, targeting recurrent glioblastoma multiforme (rGBM), with the first patient dosed at Dana-Farber Cancer Institute [1][2] Company Overview - Cue Biopharma is a clinical-stage biopharmaceutical company focused on developing therapeutic biologics that engage and modulate disease-specific T cells for treating autoimmune diseases and cancer [1][6] - The company utilizes its proprietary Immuno-STAT® platform to harness the immune system's potential without broad systemic immune modulation [6] Product Details - CUE-102 is designed to activate and expand Wilms' Tumor 1 (WT1)-specific T cells, targeting cancers that express the WT1 protein [3] - The drug has shown anti-tumor activity and a favorable tolerability profile in previous trials, with no dose-limiting toxicities reported [3] Clinical Trial Information - The Phase 1b trial (NCT06917885) aims to evaluate the tolerability and clinical activity of CUE-102 in patients with GBM at first recurrence [1] - The principal investigator, Dr. David A. Reardon, is a leader in immunotherapy for brain cancer [1][2] Industry Context - Glioblastoma is recognized as one of the most aggressive and difficult-to-treat cancers, with approximately 13,000 new cases diagnosed annually in the U.S. [4] - The average survival time post-diagnosis is around 12 to 15 months, with only 3 to 5 percent of patients surviving beyond five years [4] Mechanism of Action - CUE-102 operates by presenting the WT1 peptide to WT1-specific T cell receptors, aiming to enhance the anti-tumor immune response [2][3] - The CUE-100 series biologics provide two signals to T cells: a tumor-specific peptide and a rationally engineered interleukin 2 (IL-2) molecule to trigger T cell activation [5]

Core Insights - Cue Biopharma, Inc. is making significant progress in its clinical trials, particularly with CUE-101, which shows potential to set a new standard of care for HPV+ head and neck squamous cell carcinoma (HNSCC) patients [2] - The company reported a collaboration revenue increase to $3.0 million for Q2 2025, up from $2.7 million in Q2 2024, attributed to the timing of revenue from a collaboration with Boehringer Ingelheim [4] - Research and development expenses decreased to $7.9 million in Q2 2025 from $9.5 million in Q2 2024, mainly due to lower clinical trial costs and employee compensation [5] Business Highlights - Cue Biopharma received FDA feedback on its Pre-IND Briefing Document, reinforcing plans to advance the IND submission for CUE-401 targeting autoimmune diseases [7] - The company announced a strategic collaboration with Boehringer Ingelheim for CUE-501, which includes an upfront payment of $12 million and potential milestone payments of approximately $345 million [7] - A public offering raised around $20 million, enhancing the company's financial position [7] Clinical Trial Updates - The ongoing Phase 1 trial of CUE-101 in combination with pembrolizumab (KEYTRUDA) reported a 50% overall response rate and a 12-month overall survival rate of 88% [8] - Median overall survival for patients in the trial was reported at 32 months, indicating promising efficacy for CUE-101 [8] Financial Performance - For the three months ended June 30, 2025, the company reported a net loss of $8.5 million, an improvement from a net loss of $10.2 million in the same period of 2024 [9] - Total operating expenses decreased to $11.6 million in Q2 2025 from $13.0 million in Q2 2024, reflecting cost management efforts [9] - Cash and cash equivalents increased to $27.5 million as of June 30, 2025, compared to $22.5 million at the end of June 2024 [11]

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]