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GlycoMimetics(GLYC) - 2025 Q3 - Quarterly Report
2025-11-06 12:34
Financial Performance - The net loss for the three months ended September 30, 2025, was $24,607,000, compared to a net loss of $2,631,000 for the period from September 19, 2024, through September 30, 2024[32]. - For the nine months ended September 30, 2025, the net loss was $61,545 thousand, compared to a net loss of $2,631 thousand for the same period in 2024[41]. - The net loss per share attributable to ordinary shareholders for the nine months ended September 30, 2025, was $7.89, compared to $3.60 for the period from September 19, 2024, through September 30, 2024[32]. - Crescent recorded a net loss of $24.6 million for the three months ended September 30, 2025, compared to a loss of $2.6 million for the period from September 19, 2024, through September 30, 2024[190]. - The net loss for the nine months ended September 30, 2025, was $61.5 million, compared to a loss of $2.6 million for the same period in 2024, representing an increase in loss of $58.9 million[202]. Assets and Liabilities - As of September 30, 2025, total assets increased to $138,269,000 from $35,617,000 as of December 31, 2024, representing a growth of 287%[27]. - Total current liabilities increased to $20,304,000 from $9,614,000, reflecting a rise of 111%[27]. - Shareholders' equity improved to $116,641,000 as of September 30, 2025, from a deficit of $15,479,000 as of December 31, 2024[27]. - The balance of accumulated deficit as of September 30, 2025, was $(79,412) thousand, reflecting the ongoing losses[41]. - Cash, cash equivalents, and restricted cash at the end of the period was $133,372 thousand, an increase of $98,606 thousand from the beginning of the period[41]. Cash Flow and Financing - The company reported a net cash used in operating activities of $44,792 thousand for the nine months ended September 30, 2025[41]. - Proceeds from Pre-Closing Financing amounted to $143,027 thousand, contributing to the net cash provided by financing activities of $144,124 thousand[41]. - The company raised approximately $142.3 million in net proceeds from Pre-Closing Financing in June 2025, contributing to its liquidity position[208]. - As of September 30, 2025, the company had cash and cash equivalents of $133.3 million, expected to fund operations for at least twelve months[60]. Research and Development - Research and development expenses for the three months ended September 30, 2025, were $20,347,000, up from $2,473,000 for the same period last year[32]. - Research and development expenses for the nine months ended September 30, 2025, totaled $43.1 million, a significant increase from $2.5 million for the same period in 2024, reflecting a change of $40.6 million[203]. - Crescent's research and development expenses included $5.7 million related to chemistry, manufacturing, and development costs for CR-001 in preparation for clinical trials[197]. - The company expects significant increases in research and development and general and administrative costs related to future clinical trials and commercialization efforts[60]. - The company has incurred significant external research and development costs, totaling $8.7 million for CR-001 and $6.7 million for CR-002 for the three months ended September 30, 2025[159]. Shareholder Equity and Stock Options - The company issued 20,000,000 shares of convertible preferred stock valued at $4,000 thousand during its inception[38]. - The total stockholders' equity (deficit) as of September 30, 2025, was $116,641 thousand[38]. - The 2025 Stock Incentive Plan has an initial share pool of 2,345,962 ordinary shares, with 1,955,408 shares available as of September 30, 2025[118]. - The aggregate intrinsic value of stock options as of September 30, 2025, was $14,815 thousand, with an outstanding balance of 4,094,237 options[122]. - For the nine months ended September 30, 2025, the total share-based compensation expense was $8.55 million, with $5.25 million attributed to general and administrative expenses and $3.30 million to research and development[129]. Merger and Acquisitions - The company completed a reverse recapitalization on June 13, 2025, merging with Pre-Merger Crescent, which is focused on developing therapies for solid tumors[49]. - The merger was accounted for as a reverse recapitalization, with Pre-Merger Crescent deemed the accounting acquirer[54]. - The Exchange Ratio for the merger was set at 0.1445 shares of GlycoMimetics common stock for each share of Pre-Merger Crescent common stock, reflecting a 1-for-100 reverse stock split[52]. - Following the merger with GlycoMimetics, the company raised approximately $200.0 million in gross proceeds through a subscription agreement with investors[173]. Future Outlook - The company plans to submit an Investigational New Drug application for CR-001 in Q4 2025, with initial clinical data anticipated in the second half of 2026[165]. - The company expects to continue incurring substantial losses for the foreseeable future, with profitability dependent on the successful development and commercialization of its product candidates[168]. - The company has not generated any revenue from product sales and relies on equity offerings and debt financings for operating activities[58]. - The company has not yet commercialized any products and does not expect to generate revenue from product sales for several years[208].
GlycoMimetics(GLYC) - 2025 Q3 - Quarterly Results
2025-11-06 12:30
1 Crescent Biopharma Reports Third Quarter 2025 Financial Results and Recent Business Highlights IND Submission for CR-001, a PD-1 x VEGF Bispecific Antibody, on Track for Fourth Quarter of 2025 to Support Initiation of Global Phase 1 Trial in Patients with Solid Tumors Advancing ADCs in the Pipeline, with IND Submission for CR-002 on Track for Mid-2026 Waltham, Mass., November 6, 2025 – Crescent Biopharma, Inc. ("Crescent" or the "Company") (Nasdaq: CBIO), a biotechnology company dedicated to rapidly advan ...
GlycoMimetics(GLYC) - 2025 Q2 - Quarterly Results
2025-07-31 11:36
Crescent Biopharma, Inc. Executive Severance Plan [Plan Introduction and Definitions](index=1&type=section&id=Plan%20Introduction%20and%20Definitions) This section outlines the Executive Severance Plan's purpose, effective term, and defines critical terms. [Purpose and Term](index=1&type=section&id=Purpose%20and%20Term) - The Plan's purpose is to provide severance benefits to a select group of management or highly compensated employees of Crescent Biopharma, Inc. and its Affiliates in the event of a CIC Qualifying Termination or a Qualifying Termination[3](index=3&type=chunk) - The Plan became effective on July 29, 2025, and will remain in effect until terminated pursuant to Section 9[3](index=3&type=chunk) [Definitions](index=1&type=section&id=Definitions) - Key definitions include 'Cause' (e.g., dishonest acts, felony conviction, material failure to perform duties, gross negligence, material policy violation) and 'Good Reason' (e.g., material diminution in base salary/target bonus, relocation over 50 miles, material breach by Company, material reduction in duties for Tier 1 Participants)[3](index=3&type=chunk)[4](index=4&type=chunk) - 'Change in Control Period' is defined as the period beginning three months before and ending 12 months after the consummation of a Change in Control[3](index=3&type=chunk) - 'Qualifying Termination' refers to termination by the Company without Cause or by the Participant for Good Reason, outside of the Change in Control Period. 'CIC Qualifying Termination' refers to the same types of termination, but occurring during the Change in Control Period[3](index=3&type=chunk)[4](index=4&type=chunk) [Eligibility and Severance Benefits](index=3&type=section&id=Eligibility%20and%20Severance%20Benefits) This section details employee eligibility and severance benefits for various termination scenarios, including conditions for receipt. [Eligibility](index=3&type=section&id=Eligibility) - All employees holding the title of Vice President or higher are eligible to become Participants, subject to executing a Participation Agreement[7](index=7&type=chunk) [Qualifying Termination Benefits](index=3&type=section&id=Qualifying%20Termination%20Benefits) - Upon a Qualifying Termination, participants receive a cash amount equal to their Severance Multiplier times Base Salary, paid according to regular payroll practices[7](index=7&type=chunk) - The Company will pay monthly contributions for group health insurance (COBRA) for a number of months equal to the Participant's COBRA Multiplier, or until eligibility for another plan, or cessation of COBRA rights[7](index=7&type=chunk) [CIC Qualifying Termination Benefits](index=4&type=section&id=CIC%20Qualifying%20Termination%20Benefits) - Upon a CIC Qualifying Termination, participants receive a lump sum payment equal to their CIC Severance Multiplier multiplied by the sum of Base Salary plus Target Bonus[9](index=9&type=chunk) - Participants also receive any earned but unpaid annual bonus for the preceding year, a lump sum COBRA payment (CIC COBRA Multiplier multiplied by monthly premiums), and immediate acceleration of unvested equity-based awards (performance-based conditions deemed met at greater of target or actual performance)[9](index=9&type=chunk) [Other Termination](index=4&type=section&id=Other%20Termination) - If employment is terminated other than as a Qualifying Termination or CIC Qualifying Termination, the Participant is not entitled to any payments or benefits under this Plan[9](index=9&type=chunk) [Conditions for Severance Benefits](index=4&type=section&id=Conditions%20for%20Severance%20Benefits) - Payment of Severance Benefits is contingent upon the Participant's execution and non-revocation of a general release of claims and continued compliance with restrictive covenant obligations[9](index=9&type=chunk) - If a Participant is rehired by the Company while receiving Severance Benefits, any unpaid portion of benefits will cease[9](index=9&type=chunk)[10](index=10&type=chunk) - If it is determined that no Qualifying Termination (or CIC Qualifying Termination) occurred after benefits have been received, the Participant must repay all Severance Benefits[10](index=10&type=chunk) [Plan Administration and Legal Provisions](index=5&type=section&id=Plan%20Administration%20and%20Legal%20Provisions) This section details plan administration, funding, Section 409A compliance, amendment, claims, and excise tax provisions. [Administration](index=5&type=section&id=Administration) - The Plan is administered by the Committee (Compensation Committee of the Board) in its sole discretion, with all determinations being final and binding[13](index=13&type=chunk) - The Committee has authority to designate Participants, determine severance terms, interpret the Plan, establish rules, and make other necessary determinations[13](index=13&type=chunk) [Funding](index=5&type=section&id=Funding) - The Company's obligations under the Plan are unfunded, with all benefits payable from the general assets of the Company. Participants are considered unsecured creditors[13](index=13&type=chunk) [Section 409A Compliance](index=5&type=section&id=Section%20409A%20Compliance) - The Plan is intended to be interpreted and applied to be exempt from or comply with Section 409A of the Code[12](index=12&type=chunk) - For 'specified employees' under Section 409A, certain payments or benefits due upon termination will be delayed and paid in a lump sum on the earlier of six months and one day after separation from service or the date of death[14](index=14&type=chunk) [Amendment or Termination](index=6&type=section&id=Amendment%20or%20Termination) - The Committee may amend or terminate the Plan at any time, but any materially adverse amendment or termination will not be effective for a Participant until 12 months after the date of such action[14](index=14&type=chunk) - During a 12-month period beginning on a Change in Control, the Plan cannot be amended or terminated in a way that prevents eligibility or reduces benefits without the Participant's written consent[14](index=14&type=chunk) [General Provisions](index=6&type=section&id=General%20Provisions) - Nothing in the Plan changes a Participant's at-will employment status or guarantees employment duration[14](index=14&type=chunk) - Participants may not sell, transfer, or assign any right or interest under the Plan, and such rights are not subject to creditors' claims[14](index=14&type=chunk) - Any successor to the Company's business or assets will assume the Plan's obligations[14](index=14&type=chunk) - The Company will withhold all required federal, state, and local taxes from Severance Benefits[14](index=14&type=chunk) - Benefits payable under the Plan do not constitute compensation under other plans unless expressly provided[16](index=16&type=chunk) - The Plan and Participation Agreements constitute the entire agreement regarding severance benefits, superseding prior understandings[16](index=16&type=chunk) - The Plan is governed by ERISA and, to the extent applicable, the laws of Massachusetts[16](index=16&type=chunk) [Claims and Appeals Procedure](index=7&type=section&id=Claims%20and%20Appeals%20Procedure) - Claimants must submit a written claim to the Committee within 90 days of learning about their benefits or denial[16](index=16&type=chunk) - The Committee will provide a written decision within 90 days (with a possible 90-day extension) explaining the denial and appeal procedures[16](index=16&type=chunk) - Appeals must be requested in writing within 60 days of receiving the denial notice. The Committee will decide on the appeal within 60 days (with a possible 60-day extension)[16](index=16&type=chunk)[17](index=17&type=chunk) [Certain Excise Taxes (Parachute Tax)](index=8&type=section&id=Certain%20Excise%20Taxes%20(Parachute%20Tax)) - For Tier 1, Tier 2, and Tier 3 Participants, the Company will provide a 'Gross-Up Payment' to cover any excise tax imposed by Section 4999 of the Code (Parachute Tax)[17](index=17&type=chunk) - For Tier 4 and Tier 5 Participants, they will receive either the full amount of payments or a reduced amount ($1 less than three times their 'base amount' under Section 280G(b)(3)(A) of the Code), whichever results in the greatest after-tax receipt, without a tax gross-up[17](index=17&type=chunk)[18](index=18&type=chunk) - The Auditors (nationally recognized US public accounting firm) will determine the amounts for these excise tax provisions[17](index=17&type=chunk)[18](index=18&type=chunk) Exhibits [Exhibit A: Severance Multipliers](index=10&type=section&id=Exhibit%20A%3A%20Severance%20Multipliers) Exhibit A provides a table detailing the specific severance, COBRA, CIC severance, and CIC COBRA multipliers applicable to each of the five participant tiers under the Executive Severance Plan. Severance Multipliers | Tier | Severance Multiplier | COBRA Multiplier | CIC Severance Multiplier | CIC COBRA Multiplier | | :--- | :--- | :--- | :--- | :--- | | Tier 1 | 1.0x | 12 | 1.5x | 18 | | Tier 2 | 1.0x | 12 | 1.25x | 15 | | Tier 3 | 0.75x | 9 | 1.0x | 12 | | Tier 4 | 0.75x | 9 | 1.0x | 12 | | Tier 5 | 0.5x | 6 | 0.75x | 9 | [Exhibit B: Form of Participation Agreement](index=11&type=section&id=Exhibit%20B%3A%20Form%20of%20Participation%20Agreement) Exhibit B presents the standard form of the Participation Agreement, which formalizes an employee's enrollment in the Executive Severance Plan. - The Participation Agreement formalizes an employee's participation in the Plan, requiring acknowledgment and agreement to its terms and specifying the Participant's assigned Tier[23](index=23&type=chunk)[24](index=24&type=chunk) - For CEO and COO only, the agreement may include an additional benefit of **30% acceleration** of unvested time-based equity awards upon a
GlycoMimetics(GLYC) - 2025 Q2 - Quarterly Report
2025-07-31 11:25
FORM 10-Q Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________ to _________ Commission file number 001-36177 Crescent Biopharma, Inc. For the quarterly period ended June 30, 2025 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 (Exact name of registrant as specified in its charter) _____ ...
GlycoMimetics(GLYC) - 2025 Q1 - Quarterly Results
2025-06-18 21:28
[Condensed Balance Sheets](index=1&type=section&id=Condensed%20Balance%20Sheets) This statement presents the company's financial position, including assets, liabilities, and equity, at two distinct reporting dates Condensed Balance Sheet Highlights (in thousands) | Item | March 31, 2025 | December 31, 2024 | | :------------------------------------------ | :------------- | :---------------- | | Cash | $22,429 | $34,766 | | Total current assets | $22,838 | $34,804 | | Total assets | $25,605 | $35,617 | | Total current liabilities | $14,284 | $9,614 | | Total liabilities | $51,766 | $47,096 | | Total stockholders' deficit | $(30,161) | $(15,479) | - Cash decreased by **$12,337 thousand** from December 31, 2024, to March 31, 2025[2](index=2&type=chunk) - Total stockholders' deficit significantly increased from **$(15,479) thousand** to **$(30,161) thousand**, indicating a worsening equity position[2](index=2&type=chunk) [Condensed Statement of Operations and Comprehensive Loss](index=2&type=section&id=Condensed%20Statement%20of%20Operations%20and%20Comprehensive%20Loss) This statement details the company's financial performance, including revenues, expenses, and net loss, over a specific period Condensed Statement of Operations Highlights (Three Months Ended March 31, 2025, in thousands) | Item | Amount | | :-------------------------- | :------- | | Research and development | $10,627 | | General and administrative | $3,597 | | Total operating expenses | $14,224 | | Loss from operations | $(14,224) | | Total other expense, net | $(924) | | Net loss and comprehensive loss | $(15,148) | | Net loss per share (basic and diluted) | $(18.39) | - The company reported a net loss of **$15,148 thousand** for the three months ended March 31, 2025[5](index=5&type=chunk) - Research and development expenses were the largest component of operating expenses at **$10,627 thousand**[5](index=5&type=chunk) [Condensed Statements of Convertible Preferred Stock and Stockholders' Equity](index=3&type=section&id=Condensed%20Statements%20of%20Convertible%20Preferred%20Stock%20and%20Stockholders'%20Equity) This statement outlines changes in the company's equity and convertible preferred stock over the reporting period Changes in Stockholders' Deficit (in thousands) | Item | December 31, 2024 | March 31, 2025 | | :-------------------------------- | :---------------- | :------------- | | Convertible Preferred Stock Amount | $4,000 | $4,000 | | Common Stock Amount | $1 | $1 | | Additional Paid-in Capital | $2,387 | $2,853 | | Accumulated Deficit | $(17,867) | $(33,015) | | Total Stockholders' Deficit | $(15,479) | $(30,161) | - The accumulated deficit increased by **$15,148 thousand**, primarily due to the net loss incurred during the period[10](index=10&type=chunk) - Additional paid-in capital increased by **$466 thousand**, attributed to stock-based compensation expense[10](index=10&type=chunk) [Condensed Statements of Cash Flows](index=4&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) This statement reports the cash generated and used by operating, investing, and financing activities over a period Condensed Statements of Cash Flows Highlights (Three Months Ended March 31, 2025, in thousands) | Cash Flow Activity | Amount | | :------------------------------------ | :------- | | Net loss | $(15,148) | | Stock-based compensation expense | $1,229 | | Net cash used in operating activities | $(10,851) | | Net cash used in financing activities | $(1,486) | | Net decrease in cash | $(12,337) | | Cash at beginning of period | $34,766 | | Cash at end of period | $22,429 | - Operating activities consumed **$10,851 thousand** in cash during the three months ended March 31, 2025[14](index=14&type=chunk) - The company experienced a net decrease in cash of **$12,337 thousand**, resulting in a cash balance of **$22,429 thousand** at period end[14](index=14&type=chunk) [Notes to Condensed Financial Statements](index=5&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) These notes provide essential details and explanations supporting the condensed financial statements, clarifying accounting policies and significant events [1. Nature of the Business and Basis of Presentation](index=5&type=section&id=1.%20Nature%20of%20the%20Business%20and%20Basis%20of%20Presentation) Crescent Biopharma, Inc. was established in September 2024 to research and develop cancer therapy candidates. The company is an early-stage biopharmaceutical firm facing typical industry risks. A significant event is the Merger Agreement with GlycoMimetics, amended in February and April 2025, which will result in a combined company focused on solid tumor therapies. In connection with the Merger, Crescent completed a pre-closing financing of approximately $200.0 million. The financial statements are unaudited, prepared in accordance with GAAP for interim reporting, and reflect management's adjustments. The company has incurred significant operating losses and negative cash flows since inception, with an accumulated deficit of $33.0 million as of March 31, 2025. However, management expects that existing cash, combined with net proceeds from the Merger and Pre-Closing Financing (closed June 13, 2025), will be sufficient to fund operations for at least 12 months [Background and Basis of Presentation](index=5&type=section&id=Background%20and%20Basis%20of%20Presentation) This section outlines the company's formation, strategic merger, and the basis for financial statement preparation - Crescent Biopharma, Inc. was established on September 19, 2024, to research and develop cancer therapy candidates licensed from Paragon Therapeutics, Inc[19](index=19&type=chunk) - The Company entered into a Merger Agreement with GlycoMimetics on October 28, 2024, which was subsequently amended, leading to the formation of a combined company focused on developing cancer therapies for solid tumors[22](index=22&type=chunk) - In connection with the Merger, Crescent agreed to a Pre-Closing Financing for gross proceeds of approximately **$200.0 million**, including **$37.5 million** from convertible notes[23](index=23&type=chunk) - Immediately prior to the Merger on June 13, 2025, GlycoMimetics effected a 1-for-100 reverse stock split, and the Combined Company was re-domesticated to the Cayman Islands[24](index=24&type=chunk) [Going Concern](index=6&type=section&id=Going%20Concern) This section assesses the company's ability to continue operations, considering its financial performance and future funding - The Company has incurred a net loss of **$15.1 million** and used net cash of **$10.9 million** for operating activities during the three months ended March 31, 2025[29](index=29&type=chunk) - As of March 31, 2025, the Company had an accumulated deficit of **$33.0 million**[29](index=29&type=chunk) - Existing cash of **$22.4 million** (as of March 31, 2025), combined with **$159.5 million** net proceeds from the Merger and Pre-Closing Financing (closed June 13, 2025), is expected to fund operations for at least 12 months[30](index=30&type=chunk) [2. Summary of Significant Accounting Policies](index=7&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) This section outlines the key accounting policies applied in preparing the condensed financial statements. It covers the use of estimates, segment reporting (single segment), concentrations of credit risk (cash and third-party dependence), capitalization of deferred offering costs, fair value measurements (using a three-level hierarchy), classification of convertible preferred stock (outside stockholders' deficit), accounting for convertible notes payable (amortized cost), accruals for research and development contract costs, expensing of R&D and G&A costs as incurred, accounting for commitments and contingencies (no material liabilities as of March 31, 2025), stock-based compensation (Black-Scholes for options, hybrid method for common stock valuation), early exercise of stock options, net loss per share calculation (two-class method, anti-dilutive effect), and income taxes (asset and liability method with valuation allowance, no uncertain tax positions). The Company is also evaluating recently issued accounting pronouncements (ASU 2023-09 and ASU 2024-03) [Use of Estimates](index=7&type=section&id=Use%20of%20Estimates) This section highlights the reliance on management's judgments and assumptions in preparing the financial statements - Financial statements require management estimates and assumptions, particularly for research and development expenses, prepaid/accrued costs, and stock-based compensation valuation[31](index=31&type=chunk) [Segment Information](index=7&type=section&id=Segment%20Information) This section clarifies that the company operates and manages its business as a single reportable segment - The Company operates and manages its business as a single segment for performance assessment and operating decisions[32](index=32&type=chunk) [Concentrations of Credit Risk](index=7&type=section&id=Concentrations%20of%20Credit%20Risk) This section identifies key credit risks, including cash balances and dependence on third-party organizations - Credit risk primarily relates to cash balances held at an accredited financial institution, which may exceed federally insured limits[33](index=33&type=chunk) - The Company is dependent on third-party organizations, including Paragon, for research, development, and manufacturing of product candidates[34](index=34&type=chunk) [Deferred Offering Costs](index=7&type=section&id=Deferred%20Offering%20Costs) This section describes the capitalization and treatment of costs directly associated with equity financings - The Company capitalizes legal, professional, and other third-party fees directly associated with in-process equity financings as deferred offering costs[35](index=35&type=chunk) - As of March 31, 2025, deferred offering costs of **$2.8 million** were recorded as Other assets[35](index=35&type=chunk) [Fair Value Measurements](index=7&type=section&id=Fair%20Value%20Measurements) This section explains the methodology for classifying and measuring financial assets and liabilities at fair value - The Company classifies financial assets and liabilities carried at fair value into a three-level hierarchy (Level 1, 2, 3) based on observability of inputs[36](index=36&type=chunk) - Convertible Notes are accounted for at amortized cost, which approximates fair value utilizing Level 2 inputs[37](index=37&type=chunk) [Classification of Convertible Preferred Stock](index=8&type=section&id=Classification%20of%20Convertible%20Preferred%20Stock) This section details the accounting classification of convertible preferred stock outside of stockholders' deficit - Series Seed convertible preferred stock is classified outside of stockholders' deficit due to holders' liquidation rights not solely within the Company's control[38](index=38&type=chunk) - The Convertible Preferred Stock is not redeemable, except for a contingent deemed liquidation event, which is not currently probable[39](index=39&type=chunk) [Convertible Notes Payable (Accounting Policy)](index=8&type=section&id=Convertible%20Notes%20Payable%20%28Accounting%20Policy%29) This section outlines the accounting treatment for convertible notes payable, including amortization of debt issuance costs - Convertible Notes are accounted for at amortized cost, with debt issuance costs recorded as a debt discount and amortized as interest expense using the effective interest method[40](index=40&type=chunk) [Research and Development Contract Costs Accruals](index=8&type=section&id=Research%20and%20Development%20Contract%20Costs%20Accruals) This section describes the accrual policy for R&D expenses from vendor obligations based on service estimates - The Company accrues for R&D expenses from obligations with vendors, including Paragon, CROs, and CMOs, based on estimates of services received and work progress[42](index=42&type=chunk) - No material deviations between accrued and actual research and development expenses have been experienced as of March 31, 2025[42](index=42&type=chunk) [Research and Development Costs](index=8&type=section&id=Research%20and%20Development%20Costs) This section defines the types of research and development costs expensed as incurred by the company - Research and development costs, including salaries, stock-based compensation, employee benefits, and external vendor costs (e.g., Paragon reimbursements), are expensed as incurred[43](index=43&type=chunk) [General and Administrative Expenses](index=9&type=section&id=General%20and%20Administrative%20Expenses) This section details the primary components of the company's general and administrative expenses - General and administrative expenses primarily consist of salaries, bonuses, stock-based compensation, employee benefits, finance and administration costs, and professional fees[45](index=45&type=chunk) [Commitments and Contingencies (Accounting Policy)](index=9&type=section&id=Commitments%20and%20Contingencies%20%28Accounting%20Policy%29) This section explains the policy for accruing loss contingencies and the absence of material liabilities - The Company accrues for loss contingencies when losses are probable and reasonably estimable; no liabilities were recorded as of March 31, 2025[46](index=46&type=chunk) [Stock-Based Compensation (Accounting Policy)](index=9&type=section&id=Stock-Based%20Compensation%20%28Accounting%20Policy%29) This section outlines the accounting methods for stock-based compensation, including valuation models and recognition - Stock-based compensation expense for service-based awards is recognized using the straight-line method over the vesting period[48](index=48&type=chunk) - Stock options are valued using the Black-Scholes option-pricing model, while RSAs and RSUs are valued based on the fair value of common stock[49](index=49&type=chunk) - Common stock valuations are prepared using a hybrid method, combining an option pricing method (OPM) and a probability-weighted expected return method (PWERM)[50](index=50&type=chunk) [Early Exercise of Stock Options (Accounting Policy)](index=10&type=section&id=Early%20Exercise%20of%20Stock%20Options%20%28Accounting%20Policy%29) This section clarifies the accounting treatment for early exercised unvested stock options under the incentive plan - The 2024 Equity Incentive Plan permits early exercise of unvested options, which remain subject to repurchase by the Company and are not deemed outstanding for accounting purposes until vested[52](index=52&type=chunk) [Net Loss per Share Attributable to Common Stockholders (Accounting Policy)](index=10&type=section&id=Net%20Loss%20per%20Share%20Attributable%20to%20Common%20Stockholders%20%28Accounting%20Policy%29) This section describes the application of the two-class method for net loss per share calculation - The Company applies the two-class method for net loss per share, considering Convertible Preferred Stock as participating securities[53](index=53&type=chunk)[54](index=54&type=chunk) - In periods of net loss, basic and diluted net loss per share are the same because potentially dilutive securities have an anti-dilutive effect[57](index=57&type=chunk) [Income Taxes (Accounting Policy)](index=10&type=section&id=Income%20Taxes%20%28Accounting%20Policy%29) This section details the asset and liability method for income taxes and the use of a valuation allowance - Income taxes are accounted for using the asset and liability method, with a valuation allowance established against deferred tax assets if recovery is not more likely than not[58](index=58&type=chunk) - The Company had no uncertain tax positions or related interest/penalties accrued as of March 31, 2025[60](index=60&type=chunk) [Recently Issued Accounting Pronouncement Not Yet Adopted](index=11&type=section&id=Recently%20Issued%20Accounting%20Pronouncement%20Not%20Yet%20Adopted) This section identifies new accounting pronouncements under evaluation for their potential impact on financial statements - The Company is evaluating the impact of ASU 2023-09 (Income Tax Disclosures, effective 2025) and ASU 2024-03 (Disaggregation of Income Statement Expenses, effective 2026/2027) on its financial statements[61](index=61&type=chunk)[62](index=62&type=chunk) [3. Accrued Expenses and Other Current Liabilities](index=11&type=section&id=3.%20Accrued%20Expenses%20and%20Other%20Current%20Liabilities) Accrued expenses and other current liabilities significantly increased from $2,225 thousand at December 31, 2024, to $4,445 thousand at March 31, 2025. This increase was primarily driven by higher accrued interest, research and development costs, and employee compensation and benefits Accrued Expenses and Other Current Liabilities (in thousands) | Category | March 31, 2025 | December 31, 2024 | | :-------------------------------- | :--------------- | :---------------- | | Accrued interest | $1,960 | $852 | | Accrued research and development | $1,180 | $713 | | Accrued professional and consulting | $887 | $645 | | Accrued employee compensation and benefits | $418 | $15 | | **Total** | **$4,445** | **$2,225** | - Total accrued expenses and other current liabilities increased by **$2,220 thousand (99.8%)** from December 31, 2024, to March 31, 2025[63](index=63&type=chunk) [4. Convertible Notes Payable](index=11&type=section&id=4.%20Convertible%20Notes%20Payable) In October 2024, the Company issued Convertible Notes with an initial principal amount of $37.5 million, including $15.0 million from a related party. These notes accrue interest at 12.0% per annum, compounded annually, and are scheduled to mature on December 31, 2026. They are subject to automatic conversion into common or preferred stock upon a Next Equity Financing or other events, and holders agreed to contribute them to the Crescent Pre-Closing Financing. For the three months ended March 31, 2025, the Company recognized $1.1 million in interest expense, with an effective interest rate of approximately 12.0% - Initial principal amount of Convertible Notes: **$37.5 million** (issued October 2024), with **$15.0 million** from a related party[64](index=64&type=chunk) - Interest rate: **12.0%** per annum, compounded annually, with a maturity date of December 31, 2026[64](index=64&type=chunk) - The Convertible Notes will automatically convert into common or preferred stock upon a Next Equity Financing or other events, and holders agreed to contribute them to the Crescent Pre-Closing Financing[64](index=64&type=chunk)[65](index=65&type=chunk) - Interest expense recognized for the three months ended March 31, 2025: **$1.1 million**, with a weighted average effective interest rate of approximately **12.0%**[67](index=67&type=chunk) [5. Convertible Preferred Stock](index=12&type=section&id=5.%20Convertible%20Preferred%20Stock) On September 19, 2024, the Company issued 20,000,000 shares of Series Seed Convertible Preferred Stock to a related party, Fairmount Healthcare Fund II L.P., for gross proceeds of $4.0 million. These shares carry specific voting, conversion, dividend, liquidation, and redemption rights. As of March 31, 2025, each share was convertible into common stock on a one-for-one basis. Holders have preferential liquidation rights over common stockholders and specific voting powers on corporate actions [Voting](index=13&type=section&id=Voting) This section details the voting rights of convertible preferred stockholders, including their influence on key corporate actions - Holders of Convertible Preferred Stock vote with common stockholders on an as-converted basis[70](index=70&type=chunk) - A majority vote of preferred stockholders is required for key corporate actions, such as liquidation, adverse amendments to charter/bylaws, or authorizing senior/additional preferred stock[70](index=70&type=chunk) - Preferred stockholders are entitled to elect one director to the Company's Board[71](index=71&type=chunk) [Conversion](index=13&type=section&id=Conversion) This section outlines the conditions and mechanisms for converting convertible preferred stock into common shares - Each share of Convertible Preferred Stock is convertible into common shares at the option of the holder at any time[72](index=72&type=chunk) - Mandatory conversion occurs upon a qualifying public offering or the Merger, converting into newly created non-voting preferred stock[72](index=72&type=chunk) - As of March 31, 2025, each outstanding share of Convertible Preferred Stock was convertible into common stock on a one-for-one basis[73](index=73&type=chunk) [Dividends](index=13&type=section&id=Dividends) This section clarifies the non-cumulative nature of dividends on convertible preferred stock and historical dividend payments - Dividends on Convertible Preferred Stock are non-cumulative[74](index=74&type=chunk) - No cash dividends were declared or paid by the Company from inception (September 19, 2024) through March 31, 2025[74](index=74&type=chunk) [Liquidation](index=13&type=section&id=Liquidation) This section describes the preferential payment rights of convertible preferred stockholders in liquidation events - In a liquidation or Deemed Liquidation Event, Convertible Preferred Stock holders are entitled to preferential payment over common stockholders[75](index=75&type=chunk) - Payment amount is the greater of the original issue price plus unpaid dividends, or the as-converted common stock value[75](index=75&type=chunk) - A Deemed Liquidation Event includes certain mergers, consolidations, or sales of substantially all Company assets[76](index=76&type=chunk) [Redemption](index=14&type=section&id=Redemption) This section specifies the limited redemption rights of convertible preferred stock, contingent on a deemed liquidation event - The Convertible Preferred Stock does not have redemption rights, except for a contingent redemption upon the occurrence of a Deemed Liquidation Event[77](index=77&type=chunk) [6. Common Stock](index=14&type=section&id=6.%20Common%20Stock) As of March 31, 2025, Crescent Biopharma was authorized to issue 40,000,000 shares of common stock. There were 7,054,798 shares issued and outstanding, including those from Restricted Stock Awards (RSAs) and early exercised stock options. Each common share grants one vote, and holders are entitled to dividends declared by the Board, subject to the preferential rights of Convertible Preferred Stock. A total of 42,658,881 shares were reserved for future issuance, primarily for the conversion of preferred stock, exercise of stock options, and release of RSUs - Authorized common stock shares: **40,000,000** at **$0.0001** par value[78](index=78&type=chunk) - Issued and outstanding common shares as of March 31, 2025: **7,054,798**[2](index=2&type=chunk)[78](index=78&type=chunk) - Total common stock shares reserved for issuance (as of March 31, 2025): **42,658,881**, for potential conversion of preferred stock, exercise of stock options, and release of RSUs[79](index=79&type=chunk) [7. Stock-Based Compensation](index=14&type=section&id=7.%20Stock-Based%20Compensation) This section details the Company's stock-based compensation activities, including the 2024 Equity Incentive Plan, stock option valuation, and activity for stock options, Restricted Stock Units (RSUs), and Restricted Stock Awards (RSAs). It also covers the Parascent Warrant Obligation and the overall stock-based compensation expense. The 2024 Plan has seen multiple increases in authorized shares, totaling 24,568,516 as of March 31, 2025. Stock options are valued using the Black-Scholes model, with 19.6 million options outstanding as of March 31, 2025. RSUs and RSAs were granted with service-based vesting. The Parascent Warrant Obligation, a liability-classified award, contributed significantly to the $1.229 million total stock-based compensation expense for the three months ended March 31, 2025 [2024 Equity Incentive Plan](index=14&type=section&id=2024%20Equity%20Incentive%20Plan) This section details the company's equity incentive plan, including authorized shares and types of awards - The 2024 Equity Incentive Plan was approved on September 19, 2024, authorizing grants of stock options, restricted stock awards, restricted stock units, and other stock-based awards[80](index=80&type=chunk) - Total shares reserved for issuance under the 2024 Plan as of March 31, 2025, was **24,568,516**, with **273,224** shares available for future grants[80](index=80&type=chunk) [Stock Option Valuation](index=14&type=section&id=Stock%20Option%20Valuation) This section explains the Black-Scholes model and key assumptions used for valuing stock option grants - The fair value of stock option grants is estimated using the Black-Scholes option-pricing model[81](index=81&type=chunk) Weighted-Average Assumptions for Stock Option Valuation (Three Months Ended March 31, 2025) | Assumption | Value | | :-------------------- | :---- | | Expected term (in years) | 6.1 | | Expected volatility | 97.1% | | Risk-free interest rate | 4.2% | | Dividend yield | 0.0% | [Stock Options](index=15&type=section&id=Stock%20Options) This section summarizes the activity and intrinsic value of stock options outstanding during the period Stock Option Activity (Three Months Ended March 31, 2025) | Metric | Number of Options | | :------------------------------------ | :---------------- | | Outstanding balance as of January 1, 2025 | 7,494,090 | | Granted | 12,130,971 | | Exercised | (5,618) | | Outstanding balance as of March 31, 2025 | 19,619,443 | - The weighted average grant-date fair value of stock options granted during the three months ended March 31, 2025, was **$0.71**[83](index=83&type=chunk) - As of March 31, 2025, the aggregate intrinsic value of outstanding options was **$9.6 million**[83](index=83&type=chunk) [Restricted Stock Units](index=15&type=section&id=Restricted%20Stock%20Units) This section details the issuance and vesting conditions of Restricted Stock Units granted to employees - In March 2025, **3,033,820** RSUs were issued to certain officers and employees at a price of **$0.89** per share[84](index=84&type=chunk) - These RSUs have service-based vesting conditions over a four-year period[84](index=84&type=chunk) - The unvested balance of RSUs as of March 31, 2025, was **3,033,820**[86](index=86&type=chunk) [Restricted Stock Awards](index=16&type=section&id=Restricted%20Stock%20Awards) This section describes the issuance and unvested balance of Restricted Stock Awards to directors and consultants - In September and October 2024, **2,049,180** RSAs were issued to directors and consultants at **$0.20** per share, including related party transactions[87](index=87&type=chunk) - The unvested balance of RSAs as of March 31, 2025, was **1,707,650**[88](index=88&type=chunk) [Parascent Warrant Obligation](index=16&type=section&id=Parascent%20Warrant%20Obligation) This section outlines the obligation to grant warrants to Parascent and related compensation expense recognition - Parascent is entitled to warrants to purchase **1.00%** of the Company's fully diluted outstanding stock on December 31, 2025, and December 31, 2026[89](index=89&type=chunk)[104](index=104&type=chunk) - As of March 31, 2025, the estimated fair value of warrants to be granted on December 31, 2025, was **$2.0 million**[89](index=89&type=chunk) - For the three months ended March 31, 2025, **$0.8 million** was recognized as stock-based compensation expense related to this obligation[89](index=89&type=chunk) [Stock-Based Compensation Expense](index=17&type=section&id=Stock-Based%20Compensation%20Expense) This section presents the total stock-based compensation expense, categorized by classification and award type Stock-Based Compensation Expense by Classification (Three Months Ended March 31, 2025, in thousands) | Classification | Amount | | :-------------------------- | :------- | | General and administrative | $439 | | Research and development | $790 | | **Total** | **$1,229** | Stock-Based Compensation Expense by Award Type (Three Months Ended March 31, 2025, in thousands) | Award Type | Amount | | :-------------------------- | :------- | | Stock options | $414 | | RSAs | $21 | | RSUs | $31 | | Parascent warrant obligation | $763 | | **Total** | **$1,229** | - Total unrecognized compensation cost as of March 31, 2025, was **$16.7 million**, expected to be recognized over weighted average periods ranging from **0.8 to 4.0 years**[92](index=92&type=chunk) [8. Income Taxes](index=18&type=section&id=8.%20Income%20Taxes) For the three months ended March 31, 2025, Crescent Biopharma recorded no income tax provision. This was primarily due to the maintenance of a valuation allowance against the Company's net deferred tax assets, which offset any potential tax benefits - No income tax provision was recorded for the three months ended March 31, 2025[94](index=94&type=chunk) - The effective income tax rate differed from the **21%** federal statutory rate primarily due to the valuation allowance maintained against the Company's net deferred tax assets[94](index=94&type=chunk) [9. Paragon Option Agreements](index=18&type=section&id=9.%20Paragon%20Option%20Agreements) Crescent Biopharma entered into Option Agreements with Paragon and Parascent in September and October 2024 for cancer therapy candidates CR-001, CR-002, and CR-003. These agreements grant exclusive options to license candidates, requiring milestone payments (up to $22.0M for CR-001, $46.0M for CR-002) and tiered royalties upon commercialization. The Company exercised its option for CR-001 on March 18, 2025. Significant R&D expenses were incurred under these agreements, with $8.0 million for R&D and $0.3 million for G&A due to Paragon for the three months ended March 31, 2025. Unpaid R&D costs for CR-001, CR-002, and CR-003 totaled $8.0 million as of March 31, 2025. Additionally, the agreements include a Parascent Warrant Obligation for 1.00% of outstanding stock on a fully-diluted basis on specific grant dates - The Company entered into Antibody Paragon Option Agreement (CR-001) and ADC Paragon Option Agreement (CR-002, CR-003) with Paragon and Parascent in September and October 2024[95](index=95&type=chunk)[123](index=123&type=chunk) - Upon exercising options and finalizing license agreements, the Company will make non-refundable milestone payments of up to **$22.0 million** for CR-001 and up to **$46.0 million** for CR-002, plus tiered royalties[95](index=95&type=chunk) - The Company exercised its option for CR-001 under the Antibody Paragon Option Agreement on March 18, 2025[95](index=95&type=chunk) - For the three months ended March 31, 2025, the Company incurred **$8.0 million** in research and development expense and **$0.3 million** in general and administrative expense due to Paragon[100](index=100&type=chunk) - As of March 31, 2025, unpaid R&D costs included **$5.5 million** for CR-001, **$1.4 million** for CR-002, and **$1.1 million** for CR-003[101](index=101&type=chunk)[102](index=102&type=chunk) - The Paragon Option Agreements also include a Parascent Warrant Obligation to grant warrants for **1.00%** of outstanding capital stock on a fully-diluted basis on December 31, 2025, and December 31, 2026[104](index=104&type=chunk) [10. Commitments and Contingencies](index=20&type=section&id=10.%20Commitments%20and%20Contingencies) This section addresses the Company's commitments and contingencies, including its 401(k) Plan, indemnification agreements, and legal proceedings. The Company maintains a 401(k) Plan but recorded no matching contributions for the three months ended March 31, 2025. It provides indemnification to various parties, including directors and executive officers, but has not incurred material costs or accrued related liabilities. As of March 31, 2025, the Company was not a party to any material legal proceedings or claims [401(k) Plan](index=20&type=section&id=401%28k%29%20Plan) This section details the company's 401(k) plan for eligible employees and any related contributions - The Company maintains a defined-contribution 401(k) Plan for eligible employees[107](index=107&type=chunk) - No expense related to 401(k) Plan matching contributions was recorded for the three months ended March 31, 2025[107](index=107&type=chunk) [Indemnification Agreements](index=20&type=section&id=Indemnification%20Agreements) This section outlines the company's indemnification obligations to various parties and related financial impact - The Company provides indemnification to vendors, lessors, business partners, and its directors and executive officers[108](index=108&type=chunk) - No material costs have been incurred, and no liabilities related to such obligations were accrued as of March 31, 2025[108](index=108&type=chunk) [Legal Proceedings](index=20&type=section&id=Legal%20Proceedings) This section reports on any material legal proceedings or claims involving the company - As of March 31, 2025, the Company was not a party to any material legal proceedings or claims[109](index=109&type=chunk) [11. Net Loss per Share](index=21&type=section&id=11.%20Net%20Loss%20per%20Share) For the three months ended March 31, 2025, Crescent Biopharma reported a basic and diluted net loss per share attributable to common stockholders of $(18.39). This was based on a net loss of $(15,148) thousand and 823,664 weighted-average common shares outstanding. Potentially dilutive securities, totaling 44,366,531 shares, were excluded from the diluted EPS calculation because their effect was anti-dilutive Net Loss per Share Calculation (Three Months Ended March 31, 2025, in thousands, except share and per share amounts) | Item | Amount | | :---------------------------------------------------- | :------- | | Net loss | $(15,148) | | Weighted-average common shares outstanding, basic and diluted | 823,664 | | Net loss attributable to common stockholders, basic and diluted | $(18.39) | - Potentially dilutive securities, totaling **44,366,531** shares (including convertible preferred stock, unvested RSAs, stock options, and unvested RSUs), were excluded from diluted net loss per share calculation due to their anti-dilutive effect[112](index=112&type=chunk) [12. Related Party Transactions](index=21&type=section&id=12.%20Related%20Party%20Transactions) Fairmount, Paragon, and Parascent are identified as key related parties, holding significant ownership stakes in Crescent Biopharma. Fairmount holds approximately 74% of outstanding shares (as-converted), Paragon 9%, and Parascent 9%. Material transactions include Fairmount's $4.0 million Series Seed Preferred Stock investment and $15.0 million Convertible Note. Related party equity awards were issued to Fairmount employees. For the three months ended March 31, 2025, $8.0 million in R&D expenses and $0.3 million in G&A expenses were recognized for services from Paragon/Parascent, resulting in $8.381 million in related party accounts payable and other current liabilities - Fairmount, Paragon, and Parascent are identified as related parties, with Fairmount owning approximately **74%** of outstanding shares (as-converted), and Paragon and Parascent each owning approximately **9%**[113](index=113&type=chunk) - Fairmount invested **$4.0 million** in Series Seed Preferred Stock and holds a **$15.0 million** Convertible Note[114](index=114&type=chunk) - Related party equity awards, including RSAs and stock options, were issued to Fairmount employees[115](index=115&type=chunk) - For the three months ended March 31, 2025, **$8.0 million** in R&D expenses and **$0.3 million** in G&A expenses were recognized for services provided by Paragon and Parascent[116](index=116&type=chunk) Related Party Accounts Payable and Other Current Liabilities (as of March 31, 2025, in thousands) | Category | Amount | | :------------------------------------ | :------- | | Paragon accrued research and development | $8,097 | | Paragon accrued general and administrative | $234 | | Other | $50 | | **Total** | **$8,381** | [13. Segment Reporting](index=22&type=section&id=13.%20Segment%20Reporting) Crescent Biopharma operates as a single reportable segment focused on the research and development of its programs: CR-001, CR-002, and CR-003. The Chief Executive Officer, as the chief operating decision maker (CODM), manages operations and allocates resources on a company-wide basis, using net loss and comprehensive loss as the primary measure of segment profit or loss. For the three months ended March 31, 2025, the net loss was $15.148 million, with significant external R&D costs for its programs - The Company has one reportable segment related to the research and development of its programs (CR-001, CR-002, CR-003)[118](index=118&type=chunk) - The Chief Executive Officer, as CODM, uses net loss and comprehensive loss to assess performance and allocate resources[118](index=118&type=chunk) Segment Loss Summary (Three Months Ended March 31, 2025, in thousands) | Category | Amount | | :------------------------------------ | :------- | | CR-001 external research and development costs | $6,740 | | CR-002 external research and development costs | $1,370 | | CR-003 external research and development costs | $1,063 | | General and administrative personnel costs | $1,660 | | Research and development personnel costs | $1,431 | | Professional and consulting fees | $1,736 | | Other segment items | $1,148 | | **Net loss and comprehensive loss** | **$15,148** | [14. Subsequent Events](index=23&type=section&id=14.%20Subsequent%20Events) This section details significant events occurring after March 31, 2025, up to June 18, 2025. Key events include the Company entering into a license agreement for CR-001 and amending the Paragon ADC Option Agreement to add CR-003. Equity awards were significantly increased and granted, while some unvested shares and options were repurchased/forfeited due to a CEO change. A new sublease agreement for office space was signed. Most notably, the Merger with GlycoMimetics was completed on June 13, 2025, forming the new 'Crescent Biopharma, Inc.' after a reverse stock split and a $200.0 million Pre-Closing Financing, with shares and warrants converting based on an Exchange Ratio [Option and License Agreements (Subsequent)](index=23&type=section&id=Option%20and%20License%20Agreements%20%28Subsequent%29) This section details post-period license agreements for CR-001 and amendments to the ADC Option Agreement for CR-003 - On April 28, 2025, the Company entered into a license agreement for CR-001, including milestone payments up to **$22.0 million** and tiered royalty payments[122](index=122&type=chunk) - On April 28, 2025, the Amended and Restated Paragon ADC Option Agreement was entered to add CR-003, with potential milestone payments up to **$46.0 million**[123](index=123&type=chunk) - As of June 18, 2025, the options for CR-002 or CR-003 had not been exercised[124](index=124&type=chunk) [Equity Awards (Subsequent)](index=23&type=section&id=Equity%20Awards%20%28Subsequent%29) This section reports post-period increases in equity plan shares, new option grants, and repurchases/forfeitures due to CEO change - In April 2025, the 2024 Equity Incentive Plan was increased by **6,434,741** shares, bringing the total to **31,003,257** shares[125](index=125&type=chunk) - Options for an aggregate of **10,909,167** shares of common stock were granted to employees and consultants in April and May 2025 at exercise prices ranging from **$1.38 to $1.67** per share[125](index=125&type=chunk)[126](index=126&type=chunk) - On April 14, 2025, **885,045** unvested restricted shares were repurchased, and **3,717,141** unvested stock options were forfeited due to the former CEO's departure[127](index=127&type=chunk) [Sublease Agreement (Subsequent)](index=24&type=section&id=Sublease%20Agreement%20%28Subsequent%29) This section describes a new sublease agreement for office space entered into after the reporting period - On May 28, 2025, the Company entered into a sublease agreement for approximately **25,000 square feet** of office space in Waltham, Massachusetts[128](index=128&type=chunk) - The sublease has an initial term of **45 months**, commencing June 1, 2025, with total lease payments expected to be **$2.0 million**[128](index=128&type=chunk) [Reverse Recapitalization and Pre-Closing Financing (Subsequent)](index=24&type=section&id=Reverse%20Recapitalization%20and%20Pre-Closing%20Financing%20%28Subsequent%29) This section details the completed merger with GlycoMimetics, reverse stock split, and pre-closing financing - On June 13, 2025, the Company completed its Merger with GlycoMimetics, with GlycoMimetics changing its name to 'Crescent Biopharma, Inc.' and focusing on solid tumor therapies[129](index=129&type=chunk) - Immediately prior to the Merger, GlycoMimetics effected a **1-for-100** reverse stock split of its common stock[131](index=131&type=chunk) - The Exchange Ratio for the Merger was **0.1445** shares of GlycoMimetics common stock for each Pre-Merger Crescent common stock[131](index=131&type=chunk) - The Pre-Closing Financing raised **$200.0 million**, converting into **12,355,716** shares of common stock and **2,767,122** pre-funded warrants of the combined company[132](index=132&type=chunk)
GlycoMimetics(GLYC) - 2025 Q1 - Quarterly Report
2025-05-14 21:06
Financial Performance - The company reported a net loss of $2.3 million for the three months ended March 31, 2025, compared to a net loss of $10.7 million for the same period in 2024, representing a 78% improvement [78]. - The company incurred a net cash outflow of $5.1 million from operating activities for the three months ended March 31, 2025, compared to $10.5 million for the same period in 2024, indicating a decrease in cash burn [89]. - Interest income for Q1 2025 was $55,000, down from $378,000 in Q1 2024, a decrease of 85% due to lower cash balances [80]. Expenses - Research and development expenses decreased by $6.0 million to $15,000 in Q1 2025, down from $6.0 million in Q1 2024, a reduction of 100% due to winding down operations [78]. - General and administrative expenses decreased by $2.7 million to $2.4 million in Q1 2025, down from $5.1 million in Q1 2024, a decrease of 53% [79]. Cash Position - The company had $5.6 million in cash and cash equivalents as of March 31, 2025, which is expected to fund operations until the closing of the contemplated Merger [81]. - The company has no current plans to sell additional shares under its Sales Agreement prior to the closing of the Merger, with $66.0 million remaining available [83]. Strategic Actions - Following a strategic review, the company announced a Merger Agreement with Crescent, expected to close in late Q2 2025, which will result in Crescent becoming a wholly owned subsidiary [68]. - The company does not currently intend to continue development of uproleselan or any other drug candidates, as there are no ongoing clinical trials [67]. - If the Merger and Private Placement do not close by Q3 2025, the company may seek other strategic alternatives or liquidate [87].
Crescent Biopharma Appoints David Lubner to Board of Directors
GlobeNewswire News Room· 2025-04-28 11:30
Core Insights - Crescent Biopharma, Inc. has appointed David Lubner to its board of directors, bringing 30 years of experience in finance, operations, and corporate strategy [1][2] - The company is focused on developing precision-engineered molecules for solid tumors, with its lead program, CR-001, a tetravalent PD-1 x VEGF bispecific antibody, expected to submit an Investigational New Drug (IND) application in Q4 2025 [3][4] - Crescent's acquisition agreement with GlycoMimetics, Inc. is anticipated to close in Q2 2025, allowing the combined entity to advance Crescent's portfolio under the name Crescent Biopharma [3][4] Company Overview - Crescent Biopharma is a biotechnology company dedicated to advancing care for patients with solid tumors through novel precision-engineered molecules [4] - The company's pipeline includes three programs, with CR-001 as the lead, alongside CR-002 and CR-003, which are antibody-drug conjugates targeting undisclosed mechanisms [4] Leadership and Expertise - David Lubner's previous roles include CFO positions at Ra Pharmaceuticals, Tetraphase Pharmaceuticals, and PharMetrics, contributing significant expertise to Crescent's strategic direction [2] - Lubner is also involved with several other biotechnology companies, enhancing Crescent's network and potential for collaboration [2]
Crescent Biopharma Appoints Joshua Brumm as Chief Executive Officer and Expands Leadership Team to Advance Pipeline of Potentially Best-in-Class Oncology Therapeutics
Newsfilter· 2025-04-03 11:30
Leadership Appointments - Crescent Biopharma, Inc. announced key leadership appointments including Joshua Brumm as CEO, Jonathan McNeill, M.D. as President and COO, Ellie Im, M.D. as Chief Medical Officer, Rick Scalzo, MBA as Chief Financial Officer, and Amy Reilly as Chief Communications Officer [2][4][10][12][14] - The new leadership team brings extensive experience in oncology drug development, clinical operations, and building biotechnology companies [2][4] Company Strategy and Pipeline - Crescent is focused on developing novel precision-engineered molecules targeting solid tumors, with its lead program CR-001, a tetravalent PD-1 x VEGF bispecific antibody, on track for IND submission in Q4 2025 [2][7][15] - The company is also advancing a pipeline of novel antibody-drug conjugates (ADCs), including CR-002 and CR-003, with an IND submission for CR-002 anticipated in mid-2026 [7][15] Market Position and Vision - The leadership team aims to transform the standard of care in the immuno-oncology market, positioning Crescent to rapidly advance potentially best-in-class therapeutics across solid tumor indications [4][15] - The company is set to benefit from the collective experience of its leadership in corporate strategy, capital formation, and stakeholder engagement to progress its programs [4][10][12] Recent Developments - In October 2024, Crescent entered into an acquisition agreement with GlycoMimetics, Inc., with the combined company expected to operate under the name Crescent Biopharma and enhance its portfolio of precision-engineered biologics [7] - Initial clinical data from a Phase 1 trial for CR-001 is expected in the second half of 2026 [7]
GlycoMimetics(GLYC) - 2024 Q4 - Annual Report
2025-02-13 21:30
Merger and Corporate Restructuring - Following a strategic review, the company announced a corporate restructuring that included a workforce reduction of approximately 80%[16] - The company entered into a Merger Agreement with Crescent Biopharma, Inc., with the expectation that pre-Merger Crescent stockholders will own approximately 86.21% of the combined company[18] - The Merger is expected to close in the second quarter of 2025, subject to customary closing conditions, including stockholder approvals[22] - A concurrent Private Placement is planned for approximately $200 million, expected to close immediately following the Merger[23] - If the Merger is not completed, the company may explore strategic alternatives, including dissolution and liquidation[25] - The company plans to operate under the name Crescent Biopharma, Inc. post-Merger[22] - The Merger is intended to qualify as a tax-free reorganization under Section 368(a) of the Internal Revenue Code[22] - The proposed merger with Crescent, announced on October 29, 2024, is subject to various closing conditions that may materially affect the completion of the transaction[139] - Current securityholders are expected to own approximately 3% of the combined company's capital stock post-merger, assuming GlycoMimetics' net cash at closing is $1.8 million[142] - If GlycoMimetics' net cash falls below $1.725 million, the exchange ratio will be adjusted, resulting in a smaller ownership percentage for current stockholders[142] - A private placement of $200 million in shares is planned immediately following the merger, which will dilute the ownership of existing securityholders[148] - Current stockholders' ownership is expected to decrease from 100% to approximately 3% of the combined company, significantly reducing their influence[155] - The company may need to raise additional capital post-merger, which could lead to further dilution and operational restrictions[149] - The completion of the merger may require more time and resources than anticipated, exposing the company to operational and financial risks[159] Financial Performance and Projections - The company has incurred significant losses since inception and expects to continue incurring losses, with no assurance of achieving profitability[10] - As of December 31, 2024, the company had an accumulated deficit of $494.4 million, indicating significant losses since inception[172] - The company currently generates no revenue from drug sales and has not completed the development of any drug candidates[186] - The company expects its current cash and cash equivalents to fund operations until the closing of the proposed merger with Crescent, but this estimate is based on assumptions that may prove incorrect[174] - If development activities resume, the company would require substantial additional funding, which may not be available on commercially acceptable terms[179] - The company has devoted substantially all financial resources to research and development, but has not completed any drug development[173] Drug Development and Clinical Trials - The company reported that the Phase 3 trial for uproleselan did not achieve a statistically significant improvement in overall survival compared to chemotherapy alone[16] - A Phase 3 clinical trial for uproleselan enrolled 388 patients, but the combination with chemotherapy did not achieve a statistically significant improvement in overall survival compared to chemotherapy alone[34] - The pivotal Phase 3 clinical trial of the drug candidate uproleselan did not meet its primary endpoint of overall survival, leading to the need for additional clinical trials for regulatory approval[185] - The Phase 3 bridging trial of uproleselan conducted by Apollomics did not demonstrate favorable benefit, leading to the winding down of the program[39] - The interim analysis of the Phase 3 trial showed patients living longer than expected, leading to a recommendation for the trial to continue[33] - Clinical drug development is lengthy and expensive, with uncertain outcomes, and the company may face delays or increased costs[189] - The company remains responsible for ensuring compliance with FDA standards and good clinical practices during clinical trials[206] - Failure to register ongoing clinical trials or post results on ClinicalTrials.gov could result in fines and adverse publicity[206] Regulatory Environment and Market Challenges - The FDA's drug approval process requires substantial time and financial resources, with potential delays due to compliance issues[60] - The FDA conducts a preliminary review of NDAs within the first 60 days after submission to determine completeness[71] - The FDA may grant expedited review programs for drugs intended to treat serious conditions, which can shorten the review timeline[77] - Post-approval, drugs are subject to ongoing FDA regulation, including requirements for recordkeeping and reporting of adverse experiences[85] - The FDA may impose restrictions on marketing, labeling, and distribution of approved products, which can significantly impact market potential and profitability[86] - Drug manufacturers must comply with stringent FDA regulations, including cGMP requirements, which necessitate ongoing investment in production and quality control[87] - The FDA has the authority to withdraw product approvals if regulatory compliance is not maintained post-market[88] - The future commercial success of drug candidates is heavily reliant on adequate coverage and reimbursement from governmental and private payors[105] - Third-party payors are increasingly challenging the medical necessity and cost-effectiveness of drug products, which may require expensive pharmacoeconomic studies[106] - Legislative reforms, such as the PPACA, have introduced new fees and rebate liabilities that could impact the profitability of drug sales[109] - The Inflation Reduction Act of 2022 aims to eliminate the Medicare Part D "donut hole" and lower out-of-pocket costs, affecting drug pricing strategies[110] - Compliance with federal and state fraud and abuse laws is critical, as violations can lead to significant penalties and reputational harm[102] - The distribution of prescription drugs is subject to the Drug Supply Chain Security Act, which imposes accountability requirements[92] - The company may face challenges in maintaining adequate reimbursement levels due to increasing governmental and private insurer scrutiny on drug pricing[106] - The U.S. Department of Health and Human Services (HHS) will negotiate prices for certain high-expenditure drugs under the Medicare Drug Price Negotiation Program, starting with 10 drugs in August 2024[111] - Florida's Section 804 Importation Program (SIP) was approved to import certain drugs from Canada, potentially leading to lower drug prices[113] - Medicare payments are increasingly tied to quality of care and value measures, which may present challenges and opportunities for biopharmaceutical manufacturers[115] Competitive Landscape - The biotechnology and pharmaceutical industries are characterized by intense competition, with potential competition from large pharmaceutical companies and smaller firms[54] - Key competitive factors for the company's drug candidates include safety, efficacy, convenience, price, and availability of coverage and reimbursement[55] - The company faces significant competition from firms with greater financial resources and expertise in R&D, manufacturing, and clinical trials[56] - Collaborations may pose risks, including collaborators having significant discretion in resource allocation and potential delays in clinical trials[200] - Termination of collaboration agreements, such as the 2020 termination by Pfizer for the drug candidate rivipansel, can eliminate future funding and milestone payments[200] - If collaborators are involved in business combinations, they may deprioritize or terminate development of licensed drug candidates[201] - Delays in clinical trials and insufficient funding from collaborators could hinder the development of drug candidates[202] - Collaborators may independently develop competing drugs, impacting the commercialization of the company's drug candidates[202] - The company may need to raise additional capital if collaborations are terminated, which may not be available on acceptable terms[203] - Reliance on third-party contract research organizations (CROs) for clinical trials could lead to delays if those parties fail to perform satisfactorily[205]
GlycoMimetics(GLYC) - 2024 Q3 - Quarterly Report
2024-11-13 21:30
Financial Performance - For the three months ended September 30, 2024, total costs and expenses were $11,233,798, an increase from $9,813,496 for the same period in 2023, representing a 14.4% increase[8]. - The net loss for the nine months ended September 30, 2024, was $30,656,406, compared to a net loss of $27,820,780 for the same period in 2023, indicating an increase of 10.3%[10]. - The company reported a net loss of $9,824,000 for Q3 2024, which is a 7% increase from a net loss of $9,203,000 in Q3 2023[100]. - The company incurred a net loss of $30.7 million and had net cash flows used in operating activities of $27.4 million during the nine months ended September 30, 2024[16]. - Total costs and expenses for the nine months ended September 30, 2024, were $32.7 million, compared to $29.7 million for the same period in 2023, reflecting an increase of $3.0 million (10%) year-over-year[108]. Cash and Liquidity - The company reported cash and cash equivalents of $14,391,664 at the end of the period, down from $49,407,629 at the same time last year, a decrease of 70.9%[10]. - As of September 30, 2024, the Company had $14.4 million in cash and cash equivalents and no committed source of additional funding[16]. - The company anticipates that its current cash and cash equivalents will fund operations until the Merger closes, but there are risks associated with this estimate[90]. - The company is facing substantial doubt about its ability to continue as a going concern beyond one year from the issuance of the financial statements[16]. - The company expects its current cash resources will only be sufficient to fund operations through the closing of the contemplated Merger and Private Placement[17]. Workforce and Restructuring - The company reduced its workforce by approximately 80% in July 2024 to conserve cash resources[12]. - During the three months ended September 30, 2024, the Company incurred severance charges of $5.0 million in connection with a corporate restructuring[24]. - The Company recognized restructuring charges related to reorganization plans, which include employee termination benefits and contract termination costs[22]. - The company recorded $5.0 million in severance and related benefits charges during the three months ended September 30, 2024, due to a workforce reduction of approximately 80%[72]. Merger and Strategic Transactions - GlycoMimetics, Inc. entered into a merger agreement with Crescent Biopharma, Inc., expected to close in the second quarter of 2025, with Crescent stockholders owning approximately 86.2% of the combined company pre-merger[13]. - The merger is intended to qualify as a tax-free reorganization, with adjustments to the exchange ratio based on the company's net cash at closing[14]. - The company plans to merge with Crescent Biopharma, Inc., with the merger expected to close in the second quarter of 2025, subject to stockholder approval[13]. - The company expects to raise approximately $200 million in a private placement immediately following the merger[15]. - The company plans to initiate strategic transactions if the merger does not close by the second quarter of 2025 to raise additional capital[18]. Research and Development - Research and development expenses for the three months ended September 30, 2024, were $1,715,347, down from $5,291,790 in the same period of 2023, reflecting a decrease of 67.5%[8]. - Research and development expenses for the nine months ended September 30, 2024, were $14,026,000, a decrease of 5% from $14,783,000 in the same period of 2023[101]. - The Phase 3 trial of uproleselan did not achieve a statistically significant improvement in overall survival compared to chemotherapy alone, leading to a strategic review of alternatives[82][83]. - Following the Phase 3 trial results for uproleselan, the company decided not to conduct an additional clinical trial due to insufficient capital resources[83]. - The company is collaborating with Apollomics for the development of GMI-1687 and uproleselan in Greater China, although GMI-1687 is not actively being developed[88]. Stock and Equity - The company had 15,136,298 stock options and RSUs outstanding for the nine months ended September 30, 2024, compared to 10,971,874 for the same period in 2023[38]. - The Company has $8,830,814 of total unrecognized compensation expense related to unvested options under the 2013 Plan, expected to be recognized over approximately 2.9 years[55]. - The total intrinsic value of options exercised during the nine months ended September 30, 2024, was $4,091, compared to $82,093 for the same period in 2023[55]. - The Company issued and sold 9,822,930 shares of common stock under the 2022 Sales Agreement at a weighted average price of $3.01, generating net proceeds of $28.7 million during the nine months ended September 30, 2023[50]. - The Company's board of directors approved an increase in total authorized shares of common stock from 100,000,000 to 150,000,000 shares[49].