Drug Development and Clinical Trials - Cue Biopharma is developing a novel class of therapeutic biologics targeting disease-specific T cells, focusing on cancer and autoimmune diseases, with approximately 20 million new cancer diagnoses globally each year [129]. - The company's lead oncology candidates, CUE-101 and CUE-102, are in clinical development, with CUE-101 showing a median overall survival (mOS) of 21.8 months in patients treated in combination with KEYTRUDA, compared to 12.3 months with KEYTRUDA alone [134][136]. - CUE-101 has demonstrated an objective response rate (ORR) of 46% and a disease control rate of 75% in ongoing trials, significantly higher than the historical ORR of 19% for KEYTRUDA [134]. - CUE-102 is currently in a Phase 1 trial for late-line treatment of WT1+ cancers, with preclinical data showing selective expansion of WT1-specific CD8 T cells [143]. - The ongoing clinical data for CUE-101 and CUE-102 is expected to bolster the potential for future drug candidates addressing a broad range of cancers [132]. - The company plans to initiate a Phase 2 trial for CUE-101, with an interim analysis of ORR anticipated approximately 14 months after the first patient is dosed [140][141]. - CUE-102 demonstrated a 34% reduction in tumor burden for a gastric cancer patient at week 36, and a 40% reduction for a pancreatic cancer patient, indicating significant anti-tumor activity [144][149]. - The disease control rate for late-stage pancreatic cancer patients treated with CUE-102 is 41%, with a higher rate of 67% for patients receiving doses of 2 mg/kg and 4 mg/kg [149]. - CUE-401 is designed to selectively induce and expand regulatory T cells (Tregs) for chronic autoimmune diseases, showing promising preclinical results in suppressing self-reactive T cells [153][154]. - The CUE-500 series aims to selectively deplete autoreactive B cells using existing protective anti-viral T cell repertoire, with CUE-501 showing effective B cell killing in preclinical studies [156][157]. - CUE-501 is anticipated to have an improved safety profile compared to pan T cell engagers, with lower production of inflammatory cytokines [157]. - The company plans to provide updates on the CUE-501 program in Q4 2024, with lead candidate selection expected in Q1 2025 [157]. - The company is strategically prioritizing autoimmune programs while continuing to follow patients treated with CUE-102, with further updates expected in Q4 2024 [150]. Financial Performance and Revenue - Collaboration revenue increased by $1.2 million to $3.3 million for the three months ended September 30, 2024, from $2.1 million for the same period in 2023, primarily due to the Ono Collaboration and Option Agreement [189]. - For the nine months ended September 30, 2024, collaboration revenue rose by $4.0 million to $7.7 million, compared to $3.7 million for the same period in 2023, also driven by the Ono Collaboration and Option Agreement [189]. - The company recognized revenue of $0.05 million related to the LG Chem Collaboration Agreement for the nine months ended September 30, 2024, with a total of $19.9 million in collaboration revenue recorded since the agreement began [175]. - The company earned a $2.5 million milestone payment for the FDA's acceptance of the IND for CUE-101 under the LG Chem Collaboration Agreement [174]. - The Ono Collaboration and Option Agreement includes potential milestone payments up to an aggregate of $220 million, along with tiered royalties on sales [178]. Expenses and Cost Management - General and administrative expenses decreased by $0.7 million to $2.9 million for the three months ended September 30, 2024, from $3.6 million in the same period in 2023, mainly due to reduced employee compensation [190]. - For the nine months ended September 30, 2024, general and administrative expenses decreased by $1.5 million to $10.6 million, down from $12.1 million in the same period in 2023, attributed to lower employee compensation [190]. - Research and development expenses decreased by $0.5 million to $9.4 million for the three months ended September 30, 2024, from $9.9 million in the same period in 2023, primarily due to lower clinical trial costs [191]. - For the nine months ended September 30, 2024, research and development expenses decreased by $0.8 million to $29.1 million, compared to $29.9 million for the same period in 2023, mainly due to lower clinical trial costs [191]. Capital and Funding - Cash and cash equivalents totaled $32.4 million as of September 30, 2024, available to fund ongoing business activities [195]. - Net cash used in operating activities totaled $27.3 million for the nine months ended September 30, 2024, compared to $29.0 million for the same period in 2023, a decrease of $1.7 million [210]. - Net cash provided by financing activities totaled $11.2 million for the nine months ended September 30, 2024, compared to $7.1 million for the same period in 2023, an increase of $4.1 million [212]. - The company expects to raise additional capital to fund future operations and remain a going concern, indicating substantial doubt about its ability to continue [209]. - The company needs to raise additional capital or incur debt to fund future operations, with the ability to do so dependent on external financial, economic, and market conditions [218]. - The company may have to delay, reduce, or eliminate product development or commercialization efforts if unable to raise necessary funds, which could adversely affect business prospects [218]. - The company expects to finance cash needs through public or private equity offerings, debt financings, collaborations, and grants, but this may dilute current stockholders' ownership [220]. - If unable to raise adequate funds, the company may have to curtail technology development or operations, potentially leading to business failure [221]. - The company recorded net proceeds from a September 2024 offering of $10.8 million after deducting underwriting discounts and commissions [205]. - The company has financed its working capital primarily through equity offerings and collaborations, including cash received from Merck Sharp & Dohme Corp., LG Chem, and Ono [195]. Organizational Changes and Strategic Direction - The company completed an organizational restructuring in July 2024, resulting in an approximate 25% reduction in its workforce to strengthen operational efficiencies [216]. - The strategic restructuring aims to enhance operational efficiencies and support the development of both oncology and autoimmune programs [132]. - The company aims to establish strategic partnerships to enhance resource capabilities and fully exploit its technology platform in oncology and autoimmune disease [161]. - There were no material changes to the company's contractual obligations and commitments as of September 30, 2024, compared to December 31, 2023 [222]. - The company faces various factors affecting future capital requirements, including clinical trial costs, regulatory approval outcomes, and commercialization success [219]. - The costs associated with operating as a public company and potential disputes with collaborators could impact financial conditions [223]. - The company is not required to provide market risk disclosures as a smaller reporting company [224].

Core Insights - Cue Biopharma announces the appointment of Daniel Baker, M.D., as interim chief development officer (CDO) effective November 25, 2024, while Anish Suri, Ph.D., transitions to principal research and immunology advisor [1][2] - The organizational changes aim to enhance the company's growth and focus on advancing its drug pipeline in oncology and autoimmunity [2][3] Company Overview - Cue Biopharma is a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics designed to selectively engage and modulate disease-specific T cells for cancer and autoimmune disease treatment [1][5] - The company's proprietary platform, Immuno-STAT™, aims to harness the body's immune system without broad systemic immune modulation [5] Leadership Experience - Dr. Daniel Baker brings over 20 years of drug development experience, including significant roles at Johnson & Johnson, where he oversaw numerous Phase I-III trials leading to over 15 regulatory approvals [2][3] - Dr. Baker's previous positions include CEO and founder of Kira Therapeutics and Executive Director at Galapagos Therapeutics [2] Strategic Focus - The company aims to leverage Dr. Baker's expertise in immunotherapeutics to enhance clinical development and registrational strategies [3][4] - The transition is expected to strengthen the company's mission to deliver novel immunotherapies to patients [3]

Core Insights - Cue Biopharma presented promising clinical data for its lead oncology asset CUE-101 in combination with KEYTRUDA® for treating HPV+ recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) patients, showing an objective response rate (ORR) of 46% and a 12-month overall survival (OS) of 91.3% [1][3] - The company also reported a 67% overall disease control rate (DCR) for its second clinical asset CUE-102 in late-stage pancreatic cancer patients, indicating significant anti-tumor activity [1][5] CUE-101 Clinical Trial Data - CUE-101 demonstrated an ORR of 46% and a DCR of 75% in first-line HPV+ R/M HNSCC patients, significantly outperforming the historical ORR of 19% with pembrolizumab alone [3] - The median overall survival (mOS) for patients treated with CUE-101 was 21.8 months, compared to 12.3 months in historical trials [4] - In patients with low PD-L1 expression (CPS 1-19), the ORR reached 50% [1][3] CUE-102 Clinical Trial Data - CUE-102 showed a 67% overall DCR in late-stage pancreatic cancer patients, including an unconfirmed partial response with a 40% decrease in tumor burden [1][5] - Evidence of selective expansion of WT1-specific T cells was observed, with no dose-limiting toxicities reported during the trial [6][10] Mechanism of Action - The CUE-100 series, including CUE-101 and CUE-102, utilizes a novel mechanism to selectively engage and modulate disease-specific T cells, enhancing the immune response against tumors [8][11] - CUE-101 is designed to activate HPV16 tumor-specific T cells, while CUE-102 targets WT1-specific T cells, both aiming to improve patient outcomes in various cancers [9][10] Company Overview - Cue Biopharma is a clinical-stage biopharmaceutical company focused on developing a new class of therapeutic biologics to modulate T cells for cancer and autoimmune diseases [11][12] - The company’s proprietary Immuno-STAT platform aims to harness the body's immune system while minimizing adverse effects associated with traditional therapies [11]

Core Viewpoint - Cue Biopharma, Inc. has announced a public offering of common stock and warrants, aiming to raise approximately $12.0 million before expenses [1]. Group 1: Offering Details - The offering includes 11,564,401 shares of common stock and warrants for 2,891,100 shares, as well as pre-funded warrants for 12,435,599 shares and accompanying warrants for 3,108,900 shares [1]. - The combined public offering price for each common stock and warrant is $0.50, while the pre-funded warrants are priced at $0.499 [1]. - The offering is expected to close around September 30, 2024, pending customary closing conditions [1]. Group 2: Management and Structure - Oppenheimer & Co. Inc. is the sole book-running manager, with Newbridge Securities Corporation acting as co-manager for the offering [2]. - Cue Biopharma is led by an experienced management team and independent Board of Directors with expertise in immunology and immuno-oncology [6]. Group 3: 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]. - The company's proprietary platform, Immuno-STAT™, aims to harness the immune system's potential without broad systemic immune modulation [5].

Core Viewpoint - Cue Biopharma, Inc. is initiating an underwritten public offering of its common stock and accompanying warrants, subject to market conditions and uncertainties regarding the offering's completion and terms [1] Group 1: Offering Details - The public offering includes shares of common stock or pre-funded warrants to purchase common stock, along with accompanying warrants [1] - Oppenheimer & Co. is the sole book-running manager, while Newbridge Securities Corporation is acting as co-manager for the offering [2] - A shelf registration statement related to the offering was filed with the SEC on May 9, 2023, and declared effective on May 26, 2023 [3] Group 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 [5] - The company's proprietary platform, Immuno-STAT™, aims to harness the immune system's potential without broad systemic immune modulation [5] - The company is headquartered in Boston, Massachusetts, and is led by a management team with expertise in immunology and immuno-oncology [6]

Core Insights - Cue Biopharma, Inc. has appointed Lucinda Warren as Chief Business Officer to enhance corporate development initiatives following a recent business restructuring and prioritization of autoimmune programs [1][2][3] 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 [4] - The company's proprietary platform, Immuno-STAT™, aims to harness the body's immune system for targeted therapeutic effects without broad systemic immune modulation [4] Leadership and Experience - Lucinda Warren brings over 30 years of experience in the pharmaceutical and biotechnology sectors, having held significant roles at Johnson & Johnson and Janssen [2][3] - Her most recent position was Vice President of Business Development for Neuroscience and Japan Region at Johnson & Johnson, where she managed end-to-end business development including licensing and mergers [3] - Warren's leadership has been pivotal in optimizing resources and fostering high-performing teams, contributing to successful strategic transactions [3] Strategic Focus - The company aims to align with third-party partnerships and collaborations to develop its immunotherapy platform, with a commitment to maximizing value for shareholders and patients [3] - Warren's appointment is seen as a strategic move to enhance the company's ability to capitalize on opportunities in a timely manner [3]

Cue Biopharma, Inc. (NASDAQ:CUE) Q2 2024 Earnings Conference Call August 19, 2024 4:30 PM ET Company Participants Daniel Passeri - CEO Anish Suri - President & Chief Scientific Officer Matteo Levisetti - Chief Medical Officer Conference Call Participants Stephen Willey - Stifel Ren Benjamin - Citizens JMP Maury Raycroft - Jefferies Leland Gershell - Oppenheimer Edward Tenthoff - Piper Sandler Operator Good day, and welcome to the Cue Biopharma Second Quarter 2024 Earnings Call. All participants will be in a ...

Cue Biopharma, Inc. Q2 Earnings & Business Update Nasdaq: CUE August 19, 2024 Forward-Looking Statements Disclaimer This presentation has been prepared by Cue Biopharma, Inc. ("we," "us," "our," "Cue" or the "Company") and is made for informational purposes only and does not constitute an offer to sell or a solicitation of an offer to buy securities, nor shall there be any sale of any securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or ...

BOSTON, Aug. 19, 2024 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells, provided a business and financial update for the second quarter 2024. Recent Business Highlights Delivered oral presentation on updated data from ongoing Phase 1(b) trial of CUE-101 as a first line (1L) therapy in human papillomavirus positive (HPV+) recurrent/metastatic head and ...

Cue Biopharma, Inc. (CUE) came out with a quarterly loss of $0.20 per share versus the Zacks Consensus Estimate of a loss of $0.29. This compares to loss of $0.29 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of 31.03%. A quarter ago, it was expected that this company would post a loss of $0.30 per share when it actually produced a loss of $0.25, delivering a surprise of 16.67%. Over the last four quarters, the company has sur ...