分组1 - Cue Biopharma reported a quarterly loss of $0.07 per share, better than the Zacks Consensus Estimate of a loss of $0.10, and improved from a loss of $0.17 per share a year ago, resulting in an earnings surprise of +30.00% [1] - The company posted revenues of $2.15 million for the quarter ended September 2025, missing the Zacks Consensus Estimate by 14.04%, and down from $3.34 million in the same quarter last year [2] - Cue Biopharma shares have declined approximately 37.3% year-to-date, contrasting with the S&P 500's gain of 16.4% [3] 分组2 - The current consensus EPS estimate for the upcoming quarter is -$0.11 on revenues of $2.5 million, and for the current fiscal year, it is -$0.45 on revenues of $8.4 million [7] - 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 compared to lower-ranked industries [8]

Core Insights - Cue Biopharma, Inc. is making significant progress in advancing its Immuno-STAT platform and lead autoimmune asset, CUE-401, aimed at addressing unmet needs in autoimmune disease treatment [2][4] Business Highlights - The company reported collaboration revenue of $2.1 million for Q3 2025, down from $3.3 million in Q3 2024, attributed to the timing of revenue recognition from collaborations [4] - Research and development expenses decreased to $4.8 million in Q3 2025 from $9.4 million in Q3 2024, mainly due to reduced clinical trial costs and lower employee compensation [5] - General and administrative expenses increased to $4.9 million in Q3 2025 from $2.9 million in Q3 2024, primarily due to a one-time employee severance accrual and higher professional fees [6] Financial Results - The net loss for Q3 2025 was $7.4 million, compared to a net loss of $8.7 million in Q3 2024 [9] - Total operating expenses for Q3 2025 were $9.7 million, down from $12.2 million in Q3 2024 [9] - The company had cash and cash equivalents of $11.7 million as of September 30, 2025, down from $22.5 million at the end of 2024 [11] Strategic Developments - Cue Biopharma announced a strategic collaboration and license agreement with ImmunoScape, which includes upfront payments totaling $15 million and a 40% equity stake in ImmunoScape [7] - The company appointed Usman Azam, M.D., as President and CEO, effective September 29, 2025, to lead the next stage of growth [7] - CUE-401 is designed as a tolerogenic bifunctional molecule aimed at re-establishing immune tolerance and balance [7][12]

Drug Development and Clinical Trials - The company is preparing to file an investigational new drug (IND) application for CUE-401 in the second quarter of 2026, with human safety data expected in the second half of 2026 and proof-of-concept data in the second half of 2027[162]. - CUE-401 has shown a 50% overall response rate (ORR) in treatment-naïve patients when combined with KEYTRUDA, significantly outperforming the 19% ORR observed with KEYTRUDA alone[173]. - The company has dosed a total of 80 patients in the CUE-101 Phase 1b study, with database lock preparations expected to be completed in the fourth quarter of 2025[168]. - The CUE-500 series, including CUE-501, is being developed to target and deplete autoreactive B cells, with a collaboration agreement established with Boehringer Ingelheim International GmbH[164]. - The company anticipates that CUE-401 and the CUE-500 series represent potential breakthrough therapeutic opportunities for significant patient populations[166]. - The company has established collaborations for the development of CUE-101 and CUE-102 with ImmunoScape Pte. Ltd., focusing on oncology applications[171]. - The company plans to seek regulatory approvals for drug product candidates upon successful completion of clinical trials[233]. - The company will continue preclinical development of CUE-401 and the CUE-500 series, excluding CUE-501 which has been licensed to BI[233]. Financial Performance and Revenue - The company incurred $0.9 million in fees related to the amendment of the Einstein License in the second quarter of 2025[180]. - No revenue was recognized from the LG Chem Collaboration Agreement for the three and nine months ended September 30, 2025, with a total of $20.0 million recorded since the agreement's inception[186]. - The Ono Collaboration and Option Agreement was terminated in March 2025, with the company having recognized $0.4 million in revenue for the nine months ended September 30, 2025[190]. - The company entered into a Collaboration and License Agreement with BI on April 10, 2025, receiving an upfront payment of $10.1 million and potential milestone payments of up to $345.0 million[193]. - For the three and nine months ended September 30, 2025, the company recognized $2.1 million and $5.1 million in revenue from the BI Collaboration and License Agreement, respectively[195]. - Collaboration revenue decreased by $1.2 million for the three months ended September 30, 2025, compared to the same period in 2024, primarily due to reduced revenue from the BI Collaboration[210]. - Collaboration revenue decreased by $2.2 million for the nine months ended September 30, 2025, compared to the same period in 2024[211]. Expenses and Losses - Research and development expenses for the nine months ended September 30, 2025, totaled $21.2 million, a decrease from $29.1 million in the same period of 2024[204]. - The company reported a net loss of $7.4 million for the three months ended September 30, 2025, compared to a net loss of $8.7 million for the same period in 2024[209]. - Total operating expenses for the nine months ended September 30, 2025, were $34.1 million, down from $39.6 million in the same period of 2024[209]. - General and administrative expenses increased by $2.2 million for the nine months ended September 30, 2025, primarily due to increased professional fees and a one-time employee severance payment[213]. - Research and development expenses decreased by $7.9 million for the nine months ended September 30, 2025, primarily due to decreases in clinical trial costs and employee compensation[215]. - Interest income decreased by $0.7 million for the nine months ended September 30, 2025, due to lower interest earned on cash and cash equivalents[216]. Cash Flow and Funding - Net cash used in operating activities totaled $20.6 million for the nine months ended September 30, 2025, a decrease of $6.7 million compared to the same period in 2024[229]. - Net cash used in investing activities totaled $6.9 million for the nine months ended September 30, 2025, compared to net cash provided of less than $0.1 million in 2024[230]. - Net cash provided by financing activities totaled $16.8 million for the nine months ended September 30, 2025, an increase of $5.6 million compared to the same period in 2024[231]. - As of September 30, 2025, the company believes existing cash and marketable securities will fund operations into the third quarter of 2026, but substantial additional capital will be needed for future operations[227]. - The company recorded net proceeds from the April 2025 underwriting agreement of approximately $18.0 million after deducting expenses[226]. - The company has sold an aggregate of 11,504,093 shares under the ATM Sales Agreement for proceeds of $42.2 million since its inception[221]. - The company anticipates needing to raise additional capital or incur additional indebtedness to fund operations in the near term[235]. - The ability to raise additional funds will depend on financial, economic, and market conditions, which are largely outside the company's control[235]. - The company may need to delay, reduce, or eliminate product development or commercialization efforts if unable to raise additional funds[235]. - The company expects to finance cash needs through a combination of equity offerings, debt financings, collaborations, and grants[237]. - The company may incur additional legal, accounting, and other expenses in operating as a public company[233]. - The company may seek to access capital markets whenever conditions are favorable, even without an immediate need for additional capital[239]. Licensing and Collaboration Agreements - The company regained rights to the CUE-101 program from LG Chem, with future payments contingent on specific scenarios, while LG Chem retains rights to the CUE-102 program[185]. - ImmunoScape exercised its option to license CUE-100 series molecules, with the company receiving $5.0 million in the fourth quarter of 2025[197]. - The company has no material changes to its contractual obligations and commitments as described in its Annual Report[241].

Financial Performance - Collaboration revenue for Q3 2025 was $2.1 million, down from $3.3 million in Q3 2024, reflecting a decrease of approximately 37% due to timing differences in revenue recognition [8]. - The net loss for Q3 2025 was $7.4 million, compared to a net loss of $8.7 million in Q3 2024, representing a decrease in loss of about 14% [12]. - Total operating expenses for Q3 2025 were $9.7 million, a decrease from $12.2 million in Q3 2024, reflecting a reduction of approximately 20% [12]. - The company has a cash and cash equivalents balance of $11.7 million as of September 30, 2025, down from $22.5 million at the end of 2024 [14]. Expenses - Research and development expenses decreased to $4.8 million in Q3 2025 from $9.4 million in Q3 2024, a reduction of about 49% primarily due to lower clinical trial costs [9]. - General and administrative expenses increased to $4.9 million in Q3 2025 from $2.9 million in Q3 2024, an increase of approximately 69% attributed to a one-time employee severance accrual [10]. Strategic Initiatives - Cue Biopharma announced a strategic collaboration with ImmunoScape, which includes upfront payments totaling $15 million, with $10 million expected in Q4 2025 and $5 million in November 2026 [5]. - The company appointed Usman Azam, M.D., as President and CEO effective September 29, 2025, to lead the next stage of growth [6]. Clinical Development - The company reported a 50% overall response rate in the ongoing Phase 1 trial of CUE-101 in combination with pembrolizumab for recurrent/metastatic HPV+ head and neck cancer [7]. - Cue Biopharma's lead autoimmune asset, CUE-401, is designed to address major unmet needs in autoimmune disease treatment through its unique tolerogenic bifunctional molecule [6].

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]