GlycoMimetics(GLYC) - 2022 Q3 - Quarterly Report

PART I. FINANCIAL INFORMATION Financial Statements Unaudited Q3 2022 financial statements reveal decreased assets and equity, a lower net loss, and significant going concern doubts Balance Sheets Balance sheets show a significant decrease in total assets and stockholders' equity from December 2021 to September 2022, primarily due to reduced cash Balance Sheet Summary (Unaudited) | | September 30, 2022 ($) | December 31, 2021 ($) | | :--- | :--- | :--- | | Total Assets | $55,961,447 | $94,346,648 | | Total Liabilities | $7,843,864 | $12,742,997 | | Total Stockholders' Equity | $48,117,583 | $81,603,651 | Statements of Operations and Comprehensive Loss The company reported a reduced net loss for both the third quarter and the first nine months of 2022, primarily driven by lower research and development expenses Operating Results (Unaudited) | | Three Months Ended Sep 30, 2022 ($) | Three Months Ended Sep 30, 2021 ($) | Nine Months Ended Sep 30, 2022 ($) | Nine Months Ended Sep 30, 2021 ($) | | :--- | :--- | :--- | :--- | :--- | | Revenue | $0 | $86,560 | $75,000 | $1,142,142 | | Total Costs and Expenses | $8,767,436 | $17,423,506 | $36,855,702 | $47,163,475 | | Net Loss | $(8,523,839) | $(17,332,321) | $(36,444,447) | $(46,005,641) | | Net Loss Per Share | $(0.16) | $(0.34) | $(0.70) | $(0.90) | Statements of Stockholders' Equity Total stockholders' equity significantly decreased from December 2021 to September 2022, primarily due to the cumulative net loss for the nine-month period - The accumulated deficit grew from $(372.9) million at the end of 2021 to $(409.3) million by September 30, 2022, reflecting ongoing net losses[14] Statements of Cash Flows Net cash used in operating activities remained substantial for the nine months ended September 30, 2022, leading to a significant decline in cash and cash equivalents Cash Flow Summary (Unaudited) | | Nine Months Ended Sep 30, 2022 ($) | Nine Months Ended Sep 30, 2021 ($) | | :--- | :--- | :--- | | Net cash used in operating activities | $(38,545,919) | $(44,682,965) | | Net cash used in investing activities | $(84,190) | $(12,496) | | Net cash provided by financing activities | $0 | $9,584,728 | | Net change in cash and cash equivalents | $(38,630,109) | $(35,110,733) | | Cash and cash equivalents, end of period | $51,624,781 | $101,924,284 | Notes to Unaudited Financial Statements The notes highlight substantial doubt about the company's going concern ability, emphasizing the need for additional capital and detailing key accounting policies and expenses - Management has concluded there is substantial doubt about the company's ability to continue as a going concern for one year from the financial statement issuance date without obtaining additional financing[21] - The company's ability to fund operations depends on raising capital through equity/debt financings, collaborations, or other strategic arrangements[22] - Under the Apollomics agreement, the company did not recognize any milestone revenue in the first nine months of 2022, while in 2021 it recognized $1.1 million from clinical supplies sales[81][83] Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses clinical drug development, reduced R&D expenses from trial completion, increased G&A, and the critical need for additional funding to sustain operations - The company's lead drug candidate, uproleselan, has completed enrollment in its Phase 3 trial for relapsed/refractory AML, with an interim analysis expected by the end of 2022[91][93] Research and Development Expense by Drug Candidate (Nine Months Ended Sep 30) | (dollars in thousands) | 2022 ($) | 2021 ($) | Net Change ($) | % Change | | :--- | :--- | :--- | :--- | :--- | | Uproleselan | $11,526 | $21,064 | $(9,538) | (45)% | | GMI-1687 | $1,201 | $1,451 | $(250) | (17)% | | GMI-1359 | $120 | $509 | $(389) | (76)% | | Total R&D Expense | $22,500 | $34,596 | $(12,096) | (35)% | - The company's cash and cash equivalents of $51.6 million as of September 30, 2022, are expected to fund operations to the end of 2023[138] - Management has concluded there is substantial doubt about the company's ability to continue as a going concern beyond one year from the report's issuance without additional financing[137] Quantitative and Qualitative Disclosures about Market Risk The company's primary market risk is interest rate sensitivity on its cash and cash equivalents, though a 100 basis point change is not expected to materially impact fair value - The company's primary market risk is interest rate sensitivity on its $51.6 million in cash and cash equivalents[146] - Due to the short-term and low-risk nature of its investments, a 100 basis point change in interest rates is not expected to have a material effect on the fair market value of its cash equivalents[146] Controls and Procedures Management concluded that disclosure controls and procedures were effective as of September 30, 2022, with no material changes to internal controls over financial reporting during the quarter - Management concluded that disclosure controls and procedures were effective as of September 30, 2022[150] - There were no material changes in internal controls over financial reporting during the fiscal quarter ended September 30, 2022[151] PART II. OTHER INFORMATION Legal Proceedings The company is not currently involved in any material legal proceedings and is unaware of any pending litigation that would materially impact its operations - The company is not currently a party to any material legal proceedings[152] Risk Factors The primary risk factor is the potential delisting from Nasdaq due to non-compliance with the minimum bid price requirement, which could severely harm stock liquidity - On May 31, 2022, the company received a notice from Nasdaq for failing to meet the $1.00 minimum bid price requirement[156] - The company has a 180-day period, until November 28, 2022, to regain compliance[156] - A potential delisting from Nasdaq could make it difficult to trade the company's common stock and could hinder future capital-raising efforts[157] Unregistered Sales of Equity Securities and Use of Proceeds The company reported no unregistered sales of equity securities or use of proceeds during the reporting period - None[158] Exhibits This section lists all exhibits filed with the quarterly report, including corporate governance documents and Sarbanes-Oxley Act certifications - The exhibits include certifications from the Principal Executive Officer and Principal Financial Officer under Sections 302 and 906 of the Sarbanes-Oxley Act[160] Signatures The report was officially signed on November 9, 2022, by Brian M. Hahn, the company's Senior Vice President and Chief Financial Officer - The report was signed on November 9, 2022, by Brian M. Hahn, Senior Vice President and Chief Financial Officer[165]