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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]
Cue Biopharma to Host Business Update Call and Webcast
Globenewswire· 2025-04-14 21:02
Group 1 - Cue Biopharma, Inc. 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][3] - The company will host a conference call and webcast on April 15, 2025, at 4:30 p.m. ET to provide a business update [1][2] - Cue Biopharma's proprietary platform, Immuno-STAT™, is designed to harness the body's immune system by selectively modulating disease-specific T cells without broad systemic immune modulation [3] Group 2 - The company is headquartered in Boston, Massachusetts, and is led by a management team with expertise in immunology, protein engineering, and clinical development of protein biologics [4] - Investors can access the conference call via specific phone numbers and a webcast link, with the archived version available for 30 days [2]
Boehringer Ingelheim and Cue Biopharma partner to develop next-generation treatment for autoimmune and inflammatory diseases
Newsfilter· 2025-04-14 21:00
Core Viewpoint - Boehringer Ingelheim and Cue Biopharma have entered into a strategic research collaboration and license agreement to develop Cue Biopharma's CUE-501, a differentiated B cell depletion therapy aimed at treating autoimmune diseases [1][3]. Company Overview - Boehringer Ingelheim is a biopharmaceutical company focused on human and animal health, emphasizing innovative therapies for high unmet medical needs, with over 53,500 employees serving in more than 130 markets [5]. - Cue Biopharma is a clinical-stage biopharmaceutical company developing a novel class of injectable biologics designed to selectively engage and modulate disease-specific T cells [6][7]. Collaboration Details - The collaboration aims to leverage Cue Biopharma's proprietary T-cell engager platform to enhance the development of CUE-501, potentially providing a more effective treatment option for patients with autoimmune diseases [3][4]. - Cue Biopharma will receive an upfront payment of $12 million, along with research support payments, and could earn up to approximately $345 million in milestone-based payments and royalties on net sales [4]. Product Candidate - CUE-501 is designed to bind to a B cell specific membrane protein while selectively engaging virus-specific memory killer T cells, allowing for targeted depletion of B cells and reduction of autoimmune and inflammatory processes [2][6]. - The candidate has the potential to provide improved benefits and safety compared to existing therapies targeting B cells, aiming to reach patients earlier in their treatment journey [2][6].
Cue Biopharma, Inc. (CUE) Reports Q4 Loss, Misses Revenue Estimates
ZACKS· 2025-03-31 22:16
Group 1: Earnings Performance - Cue Biopharma reported a quarterly loss of $0.13 per share, better than the Zacks Consensus Estimate of a loss of $0.16, and improved from a loss of $0.28 per share a year ago, representing an earnings surprise of 18.75% [1] - The company has surpassed consensus EPS estimates in all four of the last quarters [2] - The revenue for the quarter ended December 2024 was $1.58 million, missing the Zacks Consensus Estimate by 5.40%, and down from $1.82 million year-over-year [2] Group 2: Stock Performance and Outlook - Cue Biopharma shares have declined approximately 15.6% since the beginning of the year, compared to a decline of 5.1% for the S&P 500 [3] - The company's earnings outlook is mixed, with the current consensus EPS estimate for the coming quarter at -$0.15 on $2 million in revenues, and -$0.55 on $13.49 million in revenues for the current fiscal year [7] Group 3: Industry Context - The Medical - Biomedical and Genetics industry, to which Cue Biopharma belongs, is currently ranked in the top 27% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact stock performance [5]
Cue Biopharma Reports Fourth Quarter and Full Year 2024 Financial Results and Business Highlights
Newsfilter· 2025-03-31 20:20
Core Viewpoint - Cue Biopharma, Inc. has reported its fourth quarter and full year 2024 financial results, highlighting progress in its autoimmune programs and the strategic focus on its Immuno-STAT™ platform, particularly CUE-401 [1][2]. Financial Results Summary Fourth Quarter 2024 - Collaboration revenue decreased to $1.6 million from $1.8 million in Q4 2023, attributed to a prior strategic collaboration with Ono Pharmaceutical [2]. - Research and development expenses were $7.2 million, down from $10.9 million in Q4 2023, mainly due to reduced drug substance manufacturing and clinical trial costs [3]. - General and administrative expenses decreased to $4.0 million from $4.6 million in Q4 2023, primarily due to lower professional fees [3]. Full Year 2024 - Collaboration revenue increased to $9.3 million from $5.5 million in 2023, driven by the strategic collaboration with Ono Pharmaceutical [4]. - Research and development expenses totaled $36.3 million, down from $40.8 million in 2023, due to decreases in clinical trial costs and employee compensation [5]. - General and administrative expenses were $14.6 million, reduced from $16.7 million in 2023, mainly due to lower employee compensation and professional fees [6]. - As of December 31, 2024, the company had $22.5 million in cash and cash equivalents [6]. Strategic Developments - The company is prioritizing resources on autoimmune programs while advancing clinical data from oncology programs to support strategic partnerships [8]. - Key industry leaders have been appointed to the management team, enhancing expertise in strategic transactions and drug development [8]. - The company has regained worldwide development and commercialization rights for CUE-401, its lead autoimmune program, which has the potential to transform treatment for various autoimmune and inflammatory diseases [8].