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Cue Biopharma Receives FDA Feedback on Pre-IND Briefing Document Reinforcing Company's Intention to Advance IND Submission for CUE-401 to Address Unmet Need in the Treatment of Autoimmune Disease
Globenewswire· 2025-06-24 20:48
Core Insights - Cue Biopharma, Inc. has received positive Pre-IND feedback from the FDA regarding its lead autoimmune asset, CUE-401, a first-in-class bispecific molecule designed to induce and expand regulatory T cells (Tregs) in vivo [1][2] - CUE-401 utilizes the combined activities of transforming growth factor beta (TGF-β) and a modified variant of interleukin 2 (IL-2) to potentially provide durable immune rebalance and tolerance for various autoimmune diseases [2][4] Company Overview - Cue Biopharma is a clinical-stage biopharmaceutical company focused on developing a novel class of therapeutic biologics that selectively engage and modulate disease-specific T cells for autoimmune disease treatment [1][8] - The company’s proprietary platform, Immuno-STAT™, aims to harness the body's intrinsic immune system without the adverse effects of broad systemic immune modulation [8] Product Details - CUE-401 is engineered to enhance the Treg induction capacity of TGF-β combined with IL-2 signaling, which is believed to improve the quality and stability of Tregs [5][6] - The design of CUE-401 allows for "conditional binding," which minimizes off-target activity and simplifies manufacturing processes [6] Mechanism of Action - CUE-401 acts as a master switch to convert autoreactive effector T cells into stable, induced T-regulatory cells (iTregs), establishing a 'tolerance positive feedback loop' that increases nonspecific Treg populations while reducing autoreactive T cells [7]
Cue Biopharma (CUE) Update / Briefing Transcript
2025-05-15 16:00
Summary of CUE Biopharma's Conference Call on May 15, 2025 Company Overview - **Company**: CUE Biopharma - **Focus**: Development of novel biologics for autoimmune and inflammatory diseases, particularly through the Q401 platform Key Points and Arguments 1. Introduction of Q401 - Q401 is highlighted as a first-in-class bispecific biologic targeting TGF beta and IL-2 to induce regulatory T cells (Tregs) for treating autoimmune diseases [4][15][20] - The mechanism of action involves transforming autoreactive effector T cells into Tregs, thereby restoring immune balance [14][21] 2. Clinical Potential - Q401 is positioned as a potential new standard of care for autoimmune and inflammatory diseases, addressing significant unmet medical needs [6][7] - The data presented supports the premise that Q401 can lead to durable immune tolerance and long-term clinical benefits [15][20] 3. Collaboration and Validation - A collaboration with Boehringer Ingelheim for the development of Q501, targeting B cells in autoimmune diseases, is noted as a validation of CUE's biologics platform [7][11] - The partnership is expected to provide non-dilutive capital while retaining rights for other applications outside B cell targeting [11] 4. Oncology Programs - Updates on oncology programs indicate promising clinical data, particularly with Q101 in treating HPV-positive head and neck squamous cell carcinoma, showing a median overall survival of over 20 months compared to historical data of 8 months [9][10] 5. Mechanistic Insights - The unique design of Q401 allows for simultaneous signaling of TGF beta and IL-2, which is crucial for Treg induction [18][21] - Challenges with traditional TGF beta and IL-2 therapies, such as off-target toxicity and short half-lives, are addressed by Q401's innovative engineering [16][17] 6. Preclinical Data - Preclinical studies demonstrate that Q401 effectively expands both natural and induced Tregs while reducing effector T cells in various autoimmune models [25][29] - The treatment shows potential for long-lasting immune regulation and suppression of autoimmune responses [36][38] 7. Expert Perspectives - Contributions from key opinion leaders, including Dr. Rich DiPaolo and Dr. Andy Cope, emphasize the transformative potential of Q401 in restoring immune homeostasis and addressing chronic inflammatory diseases [49][51] - Dr. Cope highlights the need for therapies that induce tolerance and maintain immune balance, which Q401 aims to achieve [55][61] 8. Future Directions - The company is assessing strategic pathways for Q401's clinical development, considering various autoimmune indications such as IBD, multiple sclerosis, and transplantation [72] - Plans for IND filing and further exploration of the Q500 series for additional therapeutic targets are also discussed [72] Additional Important Content - The call included a Q&A session addressing inquiries about the status of various programs, with a focus on the potential for Q401 in clinical settings [65][66] - Emphasis on the need for innovative therapies that can provide durable immune modulation rather than just symptomatic relief [56][60] This summary encapsulates the critical insights and developments shared during the conference call, reflecting CUE Biopharma's strategic focus on advancing its biologics platform for autoimmune and inflammatory diseases.
Cue Biopharma, Inc. (CUE) Reports Q1 Loss, Misses Revenue Estimates
ZACKS· 2025-05-12 22:10
Company Performance - Cue Biopharma reported a quarterly loss of $0.17 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.14, representing an earnings surprise of -21.43% [1] - The company posted revenues of $0.42 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 78.95%, compared to revenues of $1.72 million a year ago [2] - Over the last four quarters, Cue Biopharma has surpassed consensus EPS estimates three times and topped consensus revenue estimates two times [2] Stock Movement and Outlook - Cue Biopharma shares have declined approximately 28.5% since the beginning of the year, while the S&P 500 has only declined by 3.8% [3] - The company's earnings outlook is crucial for investors, as it includes current consensus earnings expectations for upcoming quarters and any recent changes to these expectations [4] - The current consensus EPS estimate for the coming quarter is -$0.14 on $2 million in revenues, and -$0.58 on $8.36 million in revenues for the current fiscal year [7] Industry Context - The Medical - Biomedical and Genetics industry, to which Cue Biopharma belongs, is currently ranked in the top 34% of over 250 Zacks industries, indicating a favorable outlook [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5] - The Zacks Rank for Cue Biopharma is currently 2 (Buy), suggesting that the shares are expected to outperform the market in the near future [6]
Cue Biopharma Reports First Quarter 2025 Financial Results and Recent Business Highlights
Globenewswire· 2025-05-12 20:05
Core Insights - Cue Biopharma announced a strategic collaboration and license agreement with Boehringer Ingelheim for CUE-501, which includes an upfront payment of $12 million and potential milestone payments of approximately $345 million [1] - The company raised gross proceeds of around $20 million in a follow-on capital raise [1] - Cue Biopharma regained worldwide rights for its lead autoimmune program, CUE-401, which has the potential to become a new standard of care for autoimmune and inflammatory diseases [1] Financial Performance - For the first quarter of 2025, Cue Biopharma reported revenue of $0.4 million, a decrease from $1.7 million in the same period of 2024, primarily due to the termination of the agreement with Ono Pharmaceutical [5] - Research and development expenses decreased to $8.5 million in Q1 2025 from $10.2 million in Q1 2024, attributed to lower clinical trial costs and employee compensation [6] - General and administrative expenses remained stable at $4.2 million for both Q1 2025 and Q1 2024 [6] Cash Position - As of March 31, 2025, the company had $13.1 million in cash and cash equivalents [7] - In April 2025, Cue Biopharma received approximately $18 million in net proceeds from an underwritten public offering [7] Upcoming Events - A virtual event is scheduled for May 15, 2025, featuring two key opinion leaders in immunology, which will highlight new preclinical data for CUE-401 and updates on the CUE-500 program [3][4]
Cue Biopharma(CUE) - 2025 Q1 - Quarterly Report
2025-05-12 20:00
[PART I. FINANCIAL INFORMATION](index=7&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Financial Statements (Unaudited)](index=7&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents the unaudited condensed consolidated financial statements, highlighting recurring losses and going concern issues [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet shows a decrease in total assets and stockholders' equity, while total liabilities increased Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $13,136 | $22,459 | | Total current assets | $15,931 | $25,138 | | Total assets | $22,254 | $32,191 | | **Liabilities & Equity** | | | | Total current liabilities | $15,498 | $13,689 | | Total liabilities | $15,674 | $14,692 | | Total stockholders' equity | $6,580 | $17,499 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company reported a net loss of $12.3 million for Q1 2025, with decreased collaboration revenue and R&D expenses Statement of Operations Highlights (in thousands) | Account | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Collaboration revenue | $421 | $1,717 | | Research and development | $8,547 | $10,199 | | General and administrative | $4,173 | $4,186 | | Loss from operations | $(12,299) | $(12,668) | | Net loss | $(12,257) | $(12,347) | | Net loss per share | $(0.17) | $(0.25) | [Condensed Consolidated Statements of Stockholders' Equity](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) Stockholders' equity significantly decreased due to the quarterly net loss, partially offset by stock-based compensation - Total stockholders' equity fell to **$6,580 thousand** as of March 31, 2025, down from **$17,499 thousand** at the end of 2024, mainly due to the quarterly net loss of **$12,257 thousand**[22](index=22&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities improved in Q1 2025, but financing activities resulted in a cash outflow Cash Flow Summary (in thousands) | Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(8,172) | $(9,784) | | Net cash used in investing activities | $(150) | $(55) | | Net cash (used in) provided by financing activities | $(1,000) | $2,354 | | **Net decrease in cash** | **$(9,322)** | **$(7,485)** | [Notes to the Condensed Consolidated Financial Statements (Unaudited)](index=11&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) The notes detail accounting policies, 'going concern' status, collaboration agreements, and recent financing events - The company's history of losses and negative cash flows raises substantial doubt about its ability to continue as a going concern within one year from the financial statement issuance date[29](index=29&type=chunk)[30](index=30&type=chunk) - In April 2025, the company received approximately **$18.0 million** in net proceeds from a public offering and a **$12.0 million** upfront payment from a new collaboration and license agreement with Boehringer Ingelheim (BI)[29](index=29&type=chunk)[130](index=130&type=chunk)[137](index=137&type=chunk) - The collaboration agreement with Ono was terminated in March 2025. For Q1 2025, the company recognized **$0.4 million** in revenue from this agreement. The LG Chem agreement generated no revenue in Q1 2025[113](index=113&type=chunk)[115](index=115&type=chunk)[111](index=111&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A)](index=35&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial condition, operations, and liquidity, emphasizing 'going concern' and future funding needs - The company is strategically prioritizing its autoimmune programs, including CUE-401 and the CUE-500 series, while seeking partnerships to advance its CUE-100 series oncology programs[9](index=9&type=chunk)[149](index=149&type=chunk)[152](index=152&type=chunk) - Management explicitly states that recurring losses and future funding needs raise substantial doubt about the company's ability to continue as a going concern[153](index=153&type=chunk)[204](index=204&type=chunk)[221](index=221&type=chunk) - Existing cash, combined with approximately **$18.0 million** from an April 2025 offering and a **$12.0 million** upfront payment from the BI collaboration, is expected to fund operations into the second quarter of 2026[199](index=199&type=chunk)[204](index=204&type=chunk) Q1 2025 vs Q1 2024 Operational Changes (in millions) | Metric | Q1 2025 | Q1 2024 | Change | Reason | | :--- | :--- | :--- | :--- | :--- | | Collaboration Revenue | $0.4 | $1.7 | $(1.3) | Termination of Ono agreement | | R&D Expenses | $8.5 | $10.2 | $(1.7) | Decreased clinical trial costs for CUE-101/102 | [Quantitative and Qualitative Disclosures about Market Risk](index=53&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a smaller reporting company, Cue Biopharma is not required to provide market risk disclosures - As a smaller reporting company, Cue Biopharma is not required to provide quantitative and qualitative disclosures about market risk[213](index=213&type=chunk) [Controls and Procedures](index=53&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective, with no material changes to internal controls - Management concluded that the company's disclosure controls and procedures were effective as of March 31, 2025[215](index=215&type=chunk) - There were no changes in internal control over financial reporting during the quarter ended March 31, 2025, that have materially affected, or are reasonably likely to materially affect, internal controls[217](index=217&type=chunk) [PART II. OTHER INFORMATION](index=54&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=54&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings - As of the report date, the company is not a party to any material legal proceedings[219](index=219&type=chunk) [Risk Factors](index=54&type=section&id=Item%201A.%20Risk%20Factors) This section highlights key business risks, including going concern, Nasdaq delisting, and trade policy impacts - The company's recurring losses and need for substantial additional capital raise substantial doubt about its ability to continue as a going concern[221](index=221&type=chunk)[222](index=222&type=chunk) - On May 12, 2025, the company received a deficiency letter from Nasdaq for failing to maintain a minimum bid price of **$1.00** per share. It has an initial 180-day period (expiring November 10, 2025) to regain compliance[227](index=227&type=chunk)[228](index=228&type=chunk) - Changes in U.S. trade policy, including recently imposed tariffs, could negatively impact the company's costs, production processes, and supply chain[223](index=223&type=chunk)[226](index=226&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=57&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no unregistered sales of equity securities during the period - None reported for the period[232](index=232&type=chunk) [Defaults Upon Senior Securities](index=57&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities - None reported[233](index=233&type=chunk) [Mine Safety Disclosures](index=57&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[234](index=234&type=chunk) [Other Information](index=57&type=section&id=Item%205.%20Other%20Information) This section discloses a Nasdaq minimum bid price deficiency and no Rule 10b5-1 trading arrangement changes - On May 12, 2025, the company received a Nasdaq deficiency notice because its common stock had closed below the **$1.00** minimum bid price for 30 consecutive business days[235](index=235&type=chunk) - The company has an initial 180-day period, until November 10, 2025, to regain compliance with Nasdaq's minimum bid price rule[236](index=236&type=chunk) - No directors or officers adopted or terminated a Rule 10b5-1 trading arrangement during the quarterly period[240](index=240&type=chunk) [Exhibits](index=58&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the 10-Q report, including collaboration agreements and certifications - Key exhibits filed include the Collaboration and License Agreement with Boehringer Ingelheim International GmbH dated April 10, 2025, and an amendment to the license agreement with Albert Einstein College of Medicine from the same date[242](index=242&type=chunk)
Cue Biopharma to Host Virtual Investor Event on May 15, 2025
Globenewswire· 2025-05-08 12:00
Core Insights - Cue Biopharma is hosting a virtual investor event on May 15, 2025, to discuss its innovative biologics platform aimed at treating autoimmune diseases and cancer [1][2] - The event will feature key opinion leaders Richard DiPaolo, PhD, and Andrew Cope, MD, PhD, who will provide insights into the company's differentiated biologics platform and its clinical trials [2][3] Company Overview - Cue Biopharma is a clinical-stage biopharmaceutical company focused on developing a novel class of therapeutic biologics that selectively engage and modulate disease-specific T cells [1][8] - The company's proprietary platform, Immuno-STAT™, is designed to harness the body's immune potential without the adverse effects of broad systemic immune modulation [8][9] Clinical Programs - The event will include a review of the CUE-400 series, highlighting new preclinical proof-of-concept data for lead candidate CUE-401, which aims to transform the standard of care for autoimmune diseases and inflammation [3] - Updates will also be provided on the CUE-500 program, including CUE-501, which has been partnered with Boehringer Ingelheim to leverage anti-viral killer T cells for autoimmune diseases and cancer [3] Expert Contributions - Richard DiPaolo, PhD, is a leading expert in inflammation and immune regulation, with significant contributions to the understanding of regulatory T cells in autoimmunity [5] - Andrew Cope, MD, PhD, has extensive experience in rheumatology and is focused on chronic inflammatory diseases, including rheumatoid arthritis [6][7]
Cue Biopharma to Participate in Fireside Chat at the Citizens Life Sciences Conference
Globenewswire· 2025-05-05 14:00
Core Insights - Cue Biopharma, Inc. is participating in the Citizens Life Sciences Conference on May 7-8, 2025, to discuss its advancements in therapeutic biologics targeting T cells for autoimmune diseases and cancer [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™, aims to harness the body's immune system's curative potential while minimizing adverse effects associated with broad systemic immune modulation [4] Conference Details - The presentation at the Citizens Life Sciences Conference is scheduled for May 8, 2025, from 11:00 a.m. to 11:25 a.m. EDT, featuring CEO Daniel Passeri [3] - A live and archived webcast of the fireside chat will be available on the company's website for 30 days [3]
Cue Biopharma(CUE) - 2025 Q1 - Quarterly Results
2025-05-12 20:00
[Underwriting Agreement Introduction](index=1&type=section&id=Underwriting%20Agreement%20Introduction) This section outlines the underwriting agreement between Cue Biopharma and Oppenheimer & Co. Inc. for a public offering [Parties and Offering](index=1&type=section&id=Parties%20and%20Offering) This section details the parties and securities offered in the public offering under the Company's effective S-3 shelf registration - The agreement is between Cue Biopharma, Inc. and Underwriters represented by **Oppenheimer & Co. Inc.** for a public offering[5](index=5&type=chunk) Securities Offered | Security Type | Quantity | | :--- | :--- | | Common Stock | 13,530,780 shares | | Pre-Funded Warrants | Up to 11,469,216 shares | | Common Warrants | Up to 6,249,999 shares | - The offering is made under the Company's **effective shelf registration statement** on **Form S-3 (File No. 333-271786)**, declared effective on May 26, 2023[6](index=6&type=chunk) [Representations and Warranties](index=4&type=section&id=SECTION%201.%20Representations%20and%20Warranties) This section details the Company's assurances regarding its financial condition, legal compliance, and offering documents [Registration Statement and Prospectuses](index=4&type=section&id=1%28a%29%28i%29%20Registration%20Statement%20and%20Prospectuses) The Company represents that its registration statement is effective, compliant, and free from stop orders - The Company confirms it is eligible to use **Form S-3** for its registration statement[14](index=14&type=chunk) - **No stop order** is in effect, and no proceedings for such an order are pending or contemplated by the SEC[14](index=14&type=chunk) - The Registration Statement, Prospectus, and all incorporated documents comply materially with the Securities Act and Exchange Act regulations[15](index=15&type=chunk)[16](index=16&type=chunk) [Accurate Disclosure](index=5&type=section&id=1%28a%29%28ii%29%20Accurate%20Disclosure) The Company warrants that all offering documents are free from material misstatements or omissions, excluding Underwriter-provided information - The Company asserts that all offering documents (Registration Statement, General Disclosure Package, Prospectus) are free from **material misstatements or omissions**[18](index=18&type=chunk) - The warranty excludes information furnished by the Underwriters, specifically related to selling concessions and certain paragraphs under the "Underwriting" section of the Prospectus[19](index=19&type=chunk) [Financial Statements](index=6&type=section&id=1%28a%29%28vi%29%20Financial%20Statements) The Company affirms its financial statements comply with U.S. GAAP and are certified by independent accountants - The financial statements fairly present the Company's financial position and have been prepared in accordance with **U.S. GAAP**[24](index=24&type=chunk) - The accountants who certified the financial statements are **independent as required by the Securities Act and PCAOB**[23](index=23&type=chunk) [No Material Adverse Change in Business](index=6&type=section&id=1%28a%29%28viii%29%20No%20Material%20Adverse%20Change%20in%20Business) The Company warrants no material adverse change in its condition or business since the last reported financial dates - No **Material Adverse Effect** has occurred since the dates of the information provided in the Registration Statement and Prospectus[26](index=26&type=chunk) [Capitalization](index=7&type=section&id=1%28a%29%28xi%29%20Capitalization) The Company confirms its capitalization details are accurate and all outstanding shares are validly issued and non-assessable - The capitalization details in the offering documents are accurate[30](index=30&type=chunk) - Outstanding shares are **fully paid and non-assessable**, and their issuance did not violate any securityholder's preemptive rights[30](index=30&type=chunk) [Accounting Controls and Disclosure Controls](index=7&type=section&id=1%28a%29%28xii%29%20Accounting%20Controls%20and%20Disclosure%20Controls) The Company represents it maintains effective internal controls over financial reporting and disclosure procedures - The Company maintains **effective internal controls over financial reporting and disclosure controls and procedures** as defined under the Exchange Act[31](index=31&type=chunk) - The audit committee and independent accountants have been advised of any material weaknesses, significant deficiencies, or fraud involving management[32](index=32&type=chunk) [Authorization of the Securities](index=8&type=section&id=1%28a%29%28xiv%29%20Authorization%20of%20the%20Securities) The offered securities are duly authorized and will be validly issued, fully paid, and non-assessable upon payment - The offered Securities are duly authorized and will be **validly issued, fully paid, and non-assessable** upon delivery and payment[34](index=34&type=chunk) - The Warrants are **valid, legal, and binding obligations**, and the underlying Warrant Shares are reserved for issuance upon exercise[34](index=34&type=chunk) [Absence of Violations, Defaults and Conflicts](index=8&type=section&id=1%28a%29%28xvi%29%20Absence%20of%20Violations%20Defaults%20and%20Conflicts) The Company is not in violation of its organizational documents or laws, and the offering will not create conflicts - The Company is not in violation of its **organizational documents, material contracts, or applicable laws**, except where it would not cause a **Material Adverse Effect**[36](index=36&type=chunk) - Consummation of the offering will not create a **conflict, breach, or default** under its agreements or violate its charter or laws[37](index=37&type=chunk) [Compliance with Food and Drug Laws](index=10&type=section&id=1%28a%29%28xxiii%29%20Compliance%20with%20Food%20and%20Drug%20Laws) The Company represents its preclinical and clinical activities materially comply with applicable food and drug laws - Preclinical and clinical activities comply with all material laws and regulations, including **good laboratory, clinical, and manufacturing practices**[45](index=45&type=chunk) - The Company has not received **warning letters or clinical hold notices from the FDA** and has not initiated any product recalls or safety alerts[46](index=46&type=chunk) [Possession of Intellectual Property](index=11&type=section&id=1%28a%29%28xxv%29%20Possession%20of%20Intellectual%20Property) The Company warrants it owns or licenses all necessary intellectual property and is unaware of infringement claims - The Company owns or possesses valid licenses to all **Intellectual Property necessary for its business**[48](index=48&type=chunk) - There are no pending or threatened actions challenging the Company's rights to its IP or asserting that the Company **infringes on the IP of others**[49](index=49&type=chunk) [No Conflicts with Sanction Laws](index=15&type=section&id=1%28a%29%28xxxvii%29%20No%20Conflicts%20with%20Sanction%20Laws) The Company represents that neither it nor its affiliates are subject to any sanctions administered by relevant authorities - The Company and its affiliates are not the **target of any Sanctions** and are not located in a **Sanctioned Territory** (e.g., Cuba, Iran, North Korea)[64](index=64&type=chunk) - Proceeds from the offering will not be used to **fund or facilitate business with any sanctioned person or in any Sanctioned Territory**[64](index=64&type=chunk) [Sale and Delivery to Underwriters; Closing](index=17&type=section&id=SECTION%202.%20Sale%20and%20Delivery%20to%20Underwriters%3B%20Closing) This section specifies the terms for the sale and delivery of securities to the Underwriters and the closing procedures [Sale, Delivery, and Payment](index=17&type=section&id=2.1%20Sale%2C%20Delivery%2C%20and%20Payment) This section details the sale of securities to Underwriters, closing procedures, and specific payment mechanisms for warrants - The Company agrees to sell, and each Underwriter **severally agrees to purchase**, the securities at the price set forth in Schedule A[76](index=76&type=chunk) - Closing is scheduled for **9:00 A.M. (New York City time)** on the first or second business day after the agreement date[77](index=77&type=chunk) - A **specific payment mechanism is outlined for Warrants**, where purchasers pay the Company directly, and Underwriters offset their commission against the payment for shares[78](index=78&type=chunk) [Covenants of the Company](index=18&type=section&id=SECTION%203.%20Covenants%20of%20the%20Company) This section outlines the Company's commitments regarding regulatory compliance, use of proceeds, and lock-up restrictions [Company Obligations](index=18&type=section&id=3.1%20Company%20Obligations) The Company covenants to comply with securities regulations, use proceeds as stated, and adhere to a 90-day lock-up period - The Company will **comply with all SEC rules**, including Rule 430B and Rule 424(b), and promptly address any SEC requests or stop orders[80](index=80&type=chunk) - The Company will use the net proceeds from the offering in the manner specified in the Prospectus under "**Use of Proceeds**"[87](index=87&type=chunk) - The Company agrees to a **90-day "Lock-Up Period"** from the date of the Prospectus, during which it will not offer, sell, or pledge additional shares of Common Stock, subject to certain exceptions[88](index=88&type=chunk)[89](index=89&type=chunk) - Exceptions to the lock-up include shares issued under employee benefit plans, in connection with M&A or strategic alliances (**up to 5% of outstanding shares**), and upon exercise of the Warrants sold in this offering[89](index=89&type=chunk) [Payment of Expenses](index=21&type=section&id=SECTION%204.%20Payment%20of%20Expenses) This section details the Company's responsibility for all expenses related to the public offering [Expense Allocation](index=21&type=section&id=4.1%20Expense%20Allocation) The Company agrees to pay all offering-related expenses, with a cap on Underwriters' counsel fees for certain matters - The Company is **responsible for all expenses** incident to the performance of its obligations under the agreement[94](index=94&type=chunk) - Specific expenses include SEC/FINRA filing fees, legal/accounting fees, road show costs, and listing fees[94](index=94&type=chunk) - If the agreement is terminated under certain conditions, the Company must **reimburse the non-defaulting Underwriters for their reasonable out-of-pocket expenses**[96](index=96&type=chunk) [Conditions of Underwriters' Obligations](index=22&type=section&id=SECTION%205.%20Conditions%20of%20Underwriters%27%20Obligations) This section lists the prerequisites that must be satisfied for the Underwriters to be obligated to purchase the securities [Closing Conditions](index=22&type=section&id=5.1%20Closing%20Conditions) This section lists the conditions for Underwriters' obligation, including legal opinions, comfort letters, and lock-up agreements - The Registration Statement must be effective with **no stop order in place**[97](index=97&type=chunk) - The Underwriters must receive legal opinions from Company counsel (**Wilmer Cutler Pickering Hale and Dorr LLP**) and IP counsel (**Bozicevic, Field & Francis LLP**)[98](index=98&type=chunk)[99](index=99&type=chunk) - The Underwriters must receive a comfort letter and a bring-down comfort letter from the Company's accountant, **RSM US LLP**[103](index=103&type=chunk)[104](index=104&type=chunk) - An officers' certificate must be delivered, confirming **no material adverse change** and the accuracy of representations[101](index=101&type=chunk) - **Lock-up agreements from persons listed on Schedule C** must be received[105](index=105&type=chunk) [Indemnification](index=23&type=section&id=SECTION%206.%20Indemnification) This section outlines the mutual indemnification obligations between the Company and the Underwriters for offering-related liabilities [Indemnification Provisions](index=23&type=section&id=6.1%20Indemnification%20Provisions) The Company and Underwriters mutually indemnify each other against losses from material misstatements or omissions in offering documents - The Company will **indemnify Underwriters for losses** resulting from **material misstatements or omissions** in the offering materials, except for information provided by the Underwriters[109](index=109&type=chunk)[110](index=110&type=chunk) - Each Underwriter **severally indemnifies the Company** for losses resulting from **material misstatements or omissions** made in reliance on written information provided by that Underwriter[111](index=111&type=chunk) - Procedures for notification of claims and selection of counsel are established. An indemnifying party cannot settle a claim without the indemnified party's consent unless it includes an **unconditional release**[112](index=112&type=chunk)[113](index=113&type=chunk) [Contribution](index=25&type=section&id=SECTION%207.%20Contribution) This section establishes a contribution mechanism if indemnification is unavailable, based on relative benefits or fault [Contribution Agreement](index=25&type=section&id=7.1%20Contribution%20Agreement) If indemnification is unavailable, parties will contribute to losses based on relative benefits or fault, with Underwriter contribution capped - If indemnification is unavailable, parties will contribute to losses based on **relative benefits or relative fault**[115](index=115&type=chunk) - Relative benefits are measured by the **net proceeds received by the Company versus the underwriting discounts received by the Underwriters**[116](index=116&type=chunk) - No Underwriter is required to contribute more than the **underwriting discounts and commissions it received**. No person guilty of fraudulent misrepresentation can seek contribution from a person not guilty of it[120](index=120&type=chunk) [Termination of Agreement](index=26&type=section&id=SECTION%209.%20Termination%20of%20Agreement) This section specifies the conditions under which the Underwriting Agreement may be terminated by the Representative [Termination Rights](index=26&type=section&id=9.1%20Termination%20Rights) The Representative can terminate the agreement due to material adverse changes in the Company or financial markets - The Representative can terminate the agreement if there is a **material adverse change in the Company's condition or business prospects**[123](index=123&type=chunk) - Termination is also possible due to **major adverse events in the financial markets**, suspension of trading, or a banking moratorium[123](index=123&type=chunk) - If terminated, no party is liable to another, except for provisions in **Sections 1, 4, 6, 7, 8, and 14-17, which survive termination**[125](index=125&type=chunk) [Miscellaneous Provisions](index=26&type=section&id=Miscellaneous%20Provisions) This section covers general legal provisions including governing law, jurisdiction, and waiver of jury trial [Governing Law and Jurisdiction](index=29&type=section&id=16%20%26%2017.%20Governing%20Law%20and%20Jurisdiction) The agreement is governed by New York law, with exclusive jurisdiction in Manhattan courts, and parties waive jury trial - The agreement is governed by the **laws of the State of New York**[138](index=138&type=chunk) - The parties consent to the **exclusive jurisdiction of federal and state courts in Manhattan, New York**, for any legal proceedings[138](index=138&type=chunk) - The parties **irrevocably waive the right to a trial by jury** for any legal proceeding related to the agreement[137](index=137&type=chunk) [Schedules and Exhibits](index=31&type=section&id=Schedules%20and%20Exhibits) This section provides detailed financial terms of the offering and the form of the lock-up agreement [Offering Terms (Schedules A & B-1)](index=31&type=section&id=Schedule%20A%20%26%20B-1.%20Offering%20Terms) These schedules outline the specific financial terms of the offering, including allocations, public prices, and exercise prices Underwriter Allocation (Schedule A) | Name of Underwriter | Underwritten Shares | Pre-Funded Warrants | Common Warrants | | :--- | :--- | :--- | :--- | | Oppenheimer & Co. Inc. | 10,824,624 | 9,175,373 | 5,000,000 | | Newbridge Securities Corporation | 2,706,156 | 2,293,843 | 1,249,999 | | **Total** | **13,530,780** | **11,469,216** | **6,249,999** | Pricing and Exercise Terms (Schedules A & B-1) | Item | Price/Value | | :--- | :--- | | Public Price (1 Share + 1/4 Common Warrant) | $0.79 | | Public Price (1 Pre-Funded Warrant + 1/4 Common Warrant) | $0.789 | | Underwriter Price (per Share/Warrant unit) | $0.7426 | | Underwriter Discount (per Share/Warrant unit) | $0.0474 | | Pre-Funded Warrant Exercise Price | $0.001 | | Common Warrant Exercise Price | $0.79 | [Form of Lock-Up Agreement (Exhibit A)](index=35&type=section&id=Exhibit%20A.%20Form%20of%20Lock-Up%20Agreement) This exhibit provides the form of the 90-day lock-up agreement for officers, directors, and certain stockholders, with standard exceptions - Signatories agree to a **90-day lock-up period**, restricting the sale or transfer of their Company securities[158](index=158&type=chunk) - Permitted transfers include **bona fide gifts, estate planning, distributions to partners/members, and transfers to immediate family**, provided the recipient also signs a lock-up agreement[159](index=159&type=chunk)[161](index=161&type=chunk) - The lock-up agreement will automatically terminate if the **public offering is not completed by April 30, 2025**[168](index=168&type=chunk)
Cue Biopharma Announces Pricing of Approximately $20 Million Public Offering
Globenewswire· 2025-04-15 02:23
Core Viewpoint - Cue Biopharma, Inc. has announced a public offering of common stock and warrants, aiming to raise approximately $20 million to support its clinical-stage biopharmaceutical development efforts [1][2]. Group 1: Offering Details - The public offering includes 13,530,780 shares of common stock and warrants for an aggregate of 3,382,695 shares, as well as pre-funded warrants for 11,469,216 shares and accompanying warrants for 2,867,304 shares [1]. - The combined public offering price for each share of common stock and accompanying warrant is set at $0.79, while the pre-funded warrant and accompanying warrant are priced at $0.789 [1]. - The offering is expected to close around April 16, 2025, pending customary closing conditions [1]. Group 2: Management and Company Background - Cue Biopharma is a clinical-stage biopharmaceutical company focused on developing a novel class of therapeutic biologics to engage and modulate disease-specific T cells for cancer and autoimmune diseases [5]. - The company utilizes its proprietary platform, Immuno-STAT™, designed to harness the immune system's potential without broad systemic immune modulation [5]. - The management team possesses extensive expertise in immunology, protein engineering, and the clinical development of protein biologics [6].
Cue Biopharma Announces Proposed Public Offering
Globenewswire· 2025-04-14 21:05
Core Viewpoint - Cue Biopharma, Inc. is initiating an underwritten public offering of its common stock and accompanying warrants, subject to market conditions, with no assurance on the completion or terms of the offering [1] 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 cancer and autoimmune disease treatment [1][5] - The company utilizes its proprietary platform, Immuno-STAT™, designed to harness the immune system's potential by selectively modulating disease-specific T cells without broad systemic immune effects [5] Offering Details - Oppenheimer & Co. Inc. is the sole book-running manager for the offering, while Newbridge Securities Corporation serves as co-manager [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] Contact Information - Investor contact is Marie Campinell, Senior Director of Corporate Communications at Cue Biopharma [10]