Strategic Prioritization and Workforce Reduction - In July 2024, the Company announced a strategic prioritization of its autoimmune programs and reduced its workforce by approximately 25% to strengthen operational efficiencies[13] - An organizational restructuring in July 2024 resulted in a 25% reduction in workforce to enhance operational efficiencies[163] Drug Development and Clinical Trials - The Company is developing a novel class of therapeutic biologics through its Immuno-STAT™ platform, targeting cancer and autoimmune diseases, with approximately 20 million new cancer diagnoses globally each year[25] - CUE-101, the Company's most advanced clinical asset, has demonstrated an overall response rate (ORR) of 46% in combination with KEYTRUDA, significantly higher than the historical ORR of 19% for KEYTRUDA alone[99] - The median overall survival (mOS) for patients treated with CUE-101 monotherapy was reported at 20.8 months and 24.6 months for different dosages, compared to historical data of 8.4 months with KEYTRUDA[101] - CUE-102, targeting WT1, has shown evidence of antitumor activity with reductions in tumor burden observed in patients, with a 34% decrease in target lesions in one gastric cancer patient[105] - CUE-401, a preclinical drug candidate for autoimmune diseases, is being developed in collaboration with Ono Pharmaceutical Co., Ltd., focusing on the induction and expansion of regulatory T cells[97] - The CUE-500 series aims to address autoimmune diseases by selectively redirecting memory T cells to deplete autoreactive B cells, demonstrating promising preclinical data[108] - The Company plans to provide further updates on the maturing data for CUE-101 and CUE-102 in the fourth quarter of 2024[107] - A proposed Phase 2 trial for CUE-101 is anticipated to begin, with an interim analysis of overall response rate expected approximately 14 months after the first patient is dosed[103] - CUE-401 demonstrated the ability to generate a robust population of FOX P3+ Tregs in preclinical studies, significantly suppressing self-reactive T cell proliferation in a mouse model of autoimmune gastritis[111] - The company anticipates selecting a clinical candidate for CUE-401 and initiating IND-enabling studies in the first half of 2025[112] - CUE-501, the lead candidate in the CUE-500 series, is designed to selectively redirect CMV-specific memory T cells to deplete B cells, showing comparable B cell killing to anti-CD3/CD19 bispecifics with reduced cytokine production[116] - The CUE-500 series aims to address autoimmune diseases by selectively targeting pathogenic immune cells, leveraging the existing protective anti-viral T cell repertoire[113] - The company plans to provide a CUE-501 program update in Q4 2024, with lead candidate selection expected in Q1 2025[116] Financial Performance and Revenue - Collaboration revenue increased by $1.3 million to $2.7 million for the three months ended June 30, 2024, compared to $1.4 million for the same period in 2023, primarily due to the Ono Collaboration and Option Agreement[145] - For the six months ended June 30, 2024, collaboration revenue rose by $2.8 million to $4.4 million from $1.6 million in the same period in 2023, also attributed to the Ono Collaboration and Option Agreement[145] - General and administrative expenses decreased by $0.7 million to $3.5 million for the three months ended June 30, 2024, from $4.2 million in the same period in 2023[146] - Research and development expenses decreased by $1.1 million to $9.5 million for the three months ended June 30, 2024, compared to $10.7 million for the same period in 2023[147] - Interest income decreased by $0.1 million to $0.4 million for the three months ended June 30, 2024, from $0.6 million in the same period in 2023[148] - The company reported net cash used in operating activities of $19.8 million for the six months ended June 30, 2024, compared to $21.2 million for the same period in 2023, reflecting a decrease of $1.4 million[158] - Net cash provided by financing activities totaled $1.4 million for the six months ended June 30, 2024, down from $2.5 million in the same period of 2023, primarily due to a $2.0 million repayment of term loans[161] - Cash used in investing activities was less than $0.1 million for the six months ended June 30, 2024, a significant decrease from $20.0 million provided in the same period of 2023 due to redemptions of marketable securities[160] Strategic Partnerships and Collaborations - The LG Chem Collaboration Agreement includes a $5.0 million upfront payment and potential additional payments of up to $400 million based on milestone achievements[130] - 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[130] - The Ono Collaboration and Option Agreement includes potential milestone payments up to an aggregate of $220 million, along with tiered royalties on sales[134] - The company is focused on establishing strategic partnerships to enhance resource capabilities and maximize the commercialization potential of its technology platform[118] - The company has forecasted the completion of R&D activities related to CUE-401 within the 24-month research term established in the Ono Collaboration and Option Agreement[136] Financial Position and Future Outlook - As of June 30, 2024, the company had cash and cash equivalents totaling $30.0 million available to fund ongoing business activities[150] - The company recorded short-term research and development liabilities of $1.0 million as of June 30, 2024[137] - The company expects to fund operations into the second quarter of 2025 with existing cash and cash equivalents, but will need to raise additional capital to continue as a going concern[158] - The company raised $30 million in gross proceeds from a private placement of common stock and warrants in November 2022[156] - The company anticipates increased expenses related to ongoing research and development of its Immuno-STAT platform and clinical trials for drug product candidates[162] - The company faces substantial doubt about its ability to continue as a going concern due to accumulated deficits and expected future losses[164] - The company plans to finance future cash needs through equity offerings, collaborations, and strategic alliances, but market conditions may hinder these efforts[165] - The company may need to grant security interests in its assets if it raises additional funds through debt financing, which could affect its financial position[169]

BOSTON, June 03, 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, today announced that it will participate in two investor conferences this June, the Jefferies Global Healthcare Conference, to be held in New York, NY, June 4-6 and the Oppenheimer Novel Targets and Immunology Summit, to be held in New York, NY on June 24. Cue Biopharma will discus ...

[About Cue Biopharma](index=3&type=section&id=About%20Cue%20Biopharma) Cue Biopharma is a clinical-stage biopharmaceutical company developing novel injectable biologics via its Immuno-STAT™ platform [Company Overview and Platform](index=3&type=section&id=Company%20Overview%20and%20Platform) Cue Biopharma is a clinical-stage biopharmaceutical company focused on developing a novel class of injectable biologics using its proprietary Immuno-STAT™ platform - Cue Biopharma is a clinical-stage biopharmaceutical company developing a novel class of injectable biologics to selectively engage and modulate disease-specific T cells[6](index=6&type=chunk)[15](index=15&type=chunk) - The company's proprietary platform, Immuno-STAT™ (Selective Targeting and Alteration of T cells), is designed to harness the body's intrinsic immune system through selective modulation of disease-specific T cells[6](index=6&type=chunk) - Headquartered in Boston, Massachusetts, the company is led by an experienced management team and independent Board of Directors with deep expertise in immunology and immuno-oncology[12](index=12&type=chunk) [Recent Business Highlights](index=1&type=section&id=Recent%20Business%20Highlights) The company advanced clinical programs, expanded its pipeline, and secured multiple conference presentations [Clinical Program Advancements](index=1&type=section&id=Clinical%20Program%20Advancements) Cue Biopharma made significant progress in its clinical programs, advancing CUE-101 and CUE-102 trials - Significant progress made in advancing the CUE-101 clinical trial, including a meeting with the FDA to define a registrational path forward[8](index=8&type=chunk) - Continued advancement of the Phase 1 clinical trial for CUE-102[8](index=8&type=chunk) [Pipeline Expansion and Collaborations](index=1&type=section&id=Pipeline%20Expansion%20and%20Collaborations) The company expanded its pipeline with the preclinical CUE-500 series and advanced the CUE-401 program with Ono Pharmaceutical - Expanded pipeline to include the preclinical CUE-500 series for the treatment of autoimmune and inflammatory diseases via T cell-mediated B cell depletion[2](index=2&type=chunk)[8](index=8&type=chunk) - Advanced preclinical CUE-401 program, in collaboration with Ono Pharmaceutical, with potential for broad application across multiple autoimmune and inflammatory diseases[7](index=7&type=chunk)[8](index=8&type=chunk) [Conference Presentations](index=1&type=section&id=Conference%20Presentations) Multiple abstracts related to CUE-101, CUE-102, and the Immuno-STAT™ platform were accepted for upcoming scientific conferences - CUE-101 abstract accepted for an oral presentation and poster presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting (May 31-June 4, 2024)[1](index=1&type=chunk) - CUE-102 abstract accepted for a poster presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting (May 31-June 4, 2024)[16](index=16&type=chunk) - Immuno-STAT™ platform posters for oncology and autoimmune diseases accepted for presentation at PEGS Boston Summit 2024 (May 13-14)[17](index=17&type=chunk) [First Quarter 2024 Financial Results](index=2&type=section&id=First%20Quarter%202024%20Financial%20Results) First quarter 2024 financial results detail cash position, operational performance, and balance sheet changes [Cash and Cash Equivalents](index=2&type=section&id=Cash%20and%20Cash%20Equivalents) As of March 31, 2024, Cue Biopharma reported $41.0 million in cash and cash equivalents, projected to fund operations into Q1 2025 - As of March 31, 2024, the Company had **$41.0 million** in cash and cash equivalents[4](index=4&type=chunk) - Current cash and cash equivalents are expected to fund operations into the first quarter of 2025[4](index=4&type=chunk)[23](index=23&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=2&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For Q1 2024, collaboration revenue significantly increased, R&D expenses rose, and the net loss was $12.3 million Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited, In thousands) | Metric | Q1 2024 ($) | Q1 2023 ($) | Change ($) | Change (%) | | :----------------------------------------- | :---------- | :---------- | :--------- | :--------- | | Collaboration revenue | 1,717 | 187 | 1,530 | 818.18% | | General and administrative expenses | 4,186 | 4,176 | 10 | 0.24% | | Research and development expenses | 10,199 | 9,391 | 808 | 8.60% | | Total operating expenses | 14,385 | 13,567 | 818 | 6.03% | | Loss from operations | (12,668) | (13,380) | 712 | -5.32% | | Net loss | (12,347) | (13,109) | 762 | -5.81% | | Net loss per common share – basic and diluted | (0.25) | (0.29) | 0.04 | -13.79% | | Weighted average common shares outstanding | 49,466,711 | 44,652,353 | 4,814,358 | 10.78% | - Collaboration revenue increased to **$1.7 million** in Q1 2024 from **$0.2 million** in Q1 2023, primarily due to revenue earned from the Collaboration and Option Agreement with Ono Pharmaceutical[18](index=18&type=chunk)[19](index=19&type=chunk) - Research and development expenses increased to **$10.2 million** in Q1 2024 from **$9.4 million** in Q1 2023, primarily due to an increase in clinical trial expenses[18](index=18&type=chunk)[19](index=19&type=chunk) [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2024, total assets decreased to $53.95 million, driven by a reduction in cash and cash equivalents Condensed Consolidated Balance Sheets (Unaudited, In thousands) | Metric | March 31, 2024 ($) | December 31, 2023 ($) | Change ($) | Change (%) | | :----------------------------------- | :----------------- | :-------------------- | :--------- | :--------- | | Cash and cash equivalents | 41,029 | 48,514 | (7,485) | -15.43% | | Other assets | 12,922 | 13,016 | (94) | -0.72% | | Total assets | 53,951 | 61,530 | (7,579) | -12.32% | | Liabilities | 23,913 | 24,445 | (532) | -2.18% | | Stockholders' equity | 30,038 | 37,085 | (7,047) | -19.00% | | Total Liabilities and stockholders' equity | 53,951 | 61,530 | (7,579) | -12.32% | [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This section outlines forward-looking statements, associated risks, and the company's disclaimer regarding updates [Disclaimer and Risk Factors](index=3&type=section&id=Disclaimer%20and%20Risk%20Factors) This section contains forward-looking statements and highlights various factors that could cause actual results to differ materially - The press release contains forward-looking statements regarding the company's strategies, prospects, financial condition, operations, costs, plans, and objectives[14](index=14&type=chunk)[23](index=23&type=chunk) - Important factors that could cause actual results to differ materially include limited operating history, ability to achieve profitability, potential setbacks in R&D efforts, challenges in securing regulatory approvals, reliance on collaborators, ability to obtain adequate financing, and competitive factors[14](index=14&type=chunk) - The company undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time[14](index=14&type=chunk) [Contact Information](index=4&type=section&id=Contact%20Information) This section provides essential contact details for investor relations and media inquiries [Investor and Media Contacts](index=4&type=section&id=Investor%20and%20Media%20Contacts) Contact information is provided for investor relations and media inquiries - Investor Contact: Marie Campinell, Senior Director, Corporate Communications, mcampinell@cuebio.com[14](index=14&type=chunk) - Media Contact: Jonathan Pappas, LifeSci Communications, jpappas@lifescicomms.com[24](index=24&type=chunk)

Title of each class Trading Symbol(s) Name of each exchange on which registered FORM 10-Q Cue Biopharma, Inc. (Exact name of registrant as specified in its charter) Securities registered pursuant to Section 12(b) of the Act: Non-accelerated filer ☒ Smaller reporting company ☒ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of th ...

BOSTON, April 24, 2024 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively modulate disease-specific T cells, announced today that it will present an oral abstract and poster at the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 31 – June 4, 2024 in Chicago, IL. The presentations will highlight the Company’s Phase 1 trials of its lead interleukin 2 (IL-2)-based biolog ...

A downtrend has been apparent in Cue Biopharma, Inc. (CUE) lately. While the stock has lost 5.4% over the past week, it could witness a trend reversal as a hammer chart pattern was formed in its last trading session. This could mean that the bulls have been able to counteract the bears to help the stock find support.The formation of a hammer pattern is considered a technical indication of nearing a bottom with likely subsiding of selling pressure. But this is not the only factor that makes a bullish case fo ...

Cue Biopharma, Inc. (NASDAQ:CUE) Q4 2023 Earnings Conference Call April 8, 2024 4:30 PM ET Company Participants Daniel Passeri - CEO Matteo Levisetti - Chief Medical Officer Anish Suri - President & Chief Scientific Officer Kerri-Ann Millar - CFO Conference Call Participants Stephen Willey - Stifel Ren Benjamin - JMP Operator Greetings and welcome to the Cue Biopharma Investor Update call. At this time, all participants are in listen-only mode. A question-and-answer session will follow the presentation. [Op ...

BOSTON, April 08, 2024 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (NASDAQ:CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively modulate disease-specific T cells, today reported fourth quarter and full year 2023 financial results. Presented additional positive data from the ongoing Phase 1 trials of CUE-101 in first line (1L) human papillomavirus positive (HPV+) recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) in combination with ...

Drug Development and Clinical Trials - The company is developing a novel series of T cell engagers, termed Immuno-STAT™, aimed at selectively modulating disease-relevant T cells while minimizing side effects [143]. - Preliminary clinical data for CUE-101 and CUE-102 suggests a potential breakthrough in modulating cancer-specific T cells directly in patients [145]. - The IND process allows for investigational products to be shipped for clinical trials, but may face delays if the FDA raises concerns [166]. - Clinical trials are conducted under strict protocols and must be submitted to the FDA as part of the IND application [174]. - The FDA requires sponsors to develop a diversity action plan for each Phase 3 clinical trial to encourage diverse patient enrollment [183]. - The FDA issued draft guidance in June 2023 aimed at modernizing clinical trial design and conduct to facilitate medical product development [186]. - The company must submit annual progress reports detailing clinical trial results to the FDA within 60 days of the IND anniversary [191]. - The FDA conducts preliminary reviews of applications within 60 days and informs sponsors if an application is complete for substantive review [198]. - The FDA's Real-Time Oncology Review program allows for early submission of relevant clinical data, potentially expediting the approval process for oncology products [268]. - Project Optimus focuses on dose optimization in oncology drug development, allowing early discussions with the FDA to enhance efficacy and safety assessments [267]. - The FDA's accelerated approval pathway is commonly utilized for oncology drugs, emphasizing the importance of robust trial designs [264]. - The FDA's new provisions under FDORA require sponsors to have confirmatory clinical trials underway before accelerated approval is granted and to submit progress reports every six months [333]. - The FDA's draft guidance emphasizes the preference for randomized controlled trials over single-arm trials for oncology drugs to ensure robust efficacy and safety assessments [334]. - Conducting clinical trials outside the U.S. may result in additional delays and expenses, as the FDA may not accept data from these trials unless specific conditions are met [337]. - Regulatory agencies can delay or deny product approval for various reasons, including safety and efficacy concerns, differing data interpretations, and changes in approval policies [341]. Financial Performance and Revenue - The company has not commenced any commercial revenue-generating operations and will need to access substantial additional capital to fund growth and operations [145]. - The company has not recognized any development, regulatory, or commercial milestone revenue from collaboration arrangements to date [201]. - For the years ended December 31, 2023 and 2022, the company recognized revenue of approximately $324,000 and $1,245,000, respectively, related to the LG Chem Collaboration Agreement [229]. - The company received a $5.0 million non-refundable upfront payment from LG Chem and is eligible for additional payments of up to approximately $400.0 million based on milestone achievements [228]. - The Ono Collaboration and Option Agreement includes a $3.0 million upfront payment and reimbursement for research costs, capped at $2.1 million for the first 18 months [234]. - As of December 31, 2023, the company recognized revenue of approximately $5,166,000 related to the Ono Collaboration and recorded short-term research and development liabilities of approximately $2,112,000 [235]. - Collaboration revenue increased to approximately $5,490,000 in 2023 from $1,245,000 in 2022, a growth of about 341% driven by the Ono Collaboration and Option Agreement [239]. - The company has not generated commercial revenue from product sales to date, relying on collaboration agreements for revenue [237]. Expenses and Losses - Research and development expenses primarily consist of compensation costs, fees to consultants, and clinical trial costs related to drug product candidates [202]. - Research and development expenses rose to $40,802,000 in 2023 from $38,578,000 in 2022, an increase of about 5.8% [239]. - General and administrative expenses rose to approximately $16,680,000 in 2023 from $16,169,000 in 2022, an increase of about $511,000 primarily due to higher professional fees and employee compensation [240]. - Total operating expenses increased to $57,639,000 in 2023 from $54,470,000 in 2022, reflecting a rise of approximately 4% [239]. - Net loss for 2023 was $50,733,000 compared to a net loss of $53,010,000 in 2022, showing an improvement of about 4.3% [239]. - Net loss per common share improved to $(1.11) in 2023 from $(1.49) in 2022 [239]. - Stock-based compensation in general and administrative expenses was $3,687,000 for 2023, down from $4,615,000 in 2022, a decrease of approximately 20.1% [296][297]. - The company anticipates that research and development expenses will continue to rise due to ongoing clinical trials and potential future drug candidates [292]. Capital and Funding - The company maintains a full valuation allowance against its net deferred tax assets due to historical net operating losses, resulting in no provision for income taxes for the years ended December 31, 2023 and 2022 [215]. - Cash, cash equivalents, and marketable securities totaled approximately $48.5 million as of December 31, 2023, down from approximately $76.3 million in 2022, indicating a decrease of about 36.4% [307]. - The company sold 4,006,966 shares of common stock under the October 2021 ATM Agreement for proceeds of approximately $13.4 million in 2023, with total proceeds from this agreement reaching $37.0 million as of December 31, 2023 [310]. - The company has registered for sale up to $300 million of common stock, preferred stock, debt securities, and other financial instruments as of May 26, 2023 [309]. - The Loan Agreement, amended in April 2023, includes a floating interest rate and requires monthly interest payments, with all principal and interest due by December 1, 2025 [311]. - The company received approximately $30 million in gross proceeds from a private placement of common stock and warrants in November 2022, after deducting placement agent fees and expenses [316]. Competition and Regulatory Environment - The company faces significant competition from established competitors with greater financial and technical resources, which may impact its growth [159]. - The company is subject to extensive regulations governing the research, development, and approval of its drug product candidates, requiring substantial time and financial resources [161]. - The company is subject to ongoing regulatory requirements post-approval, including compliance with GMP regulations and reporting adverse reactions [273]. - The company may seek accelerated development pathways for drug product candidates, which could impact the timeline and costs associated with obtaining marketing approvals [329]. - Failure to obtain or maintain accelerated approval could lead to longer commercialization timelines and increased development costs, negatively impacting the company's competitive position [335].

BOSTON, Feb. 29, 2024 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (NASDAQ:CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively modulate disease-specific T cells, announced today that the company's lead clinical asset, CUE-101, will be featured in a presentation at the 2024 Multi-disciplinary Head and Neck Cancers Symposium given by Alexander Dimitrios Colevas, M.D., a principal investigator at Stanford University participating in the CUE-101 clinical ...