GlycoMimetics(GLYC) - 2022 Q2 - Quarterly Report

PART I. FINANCIAL INFORMATION Financial Statements The company reported a $27.9 million net loss for H1 2022, with assets at $65.0 million, and faces substantial doubt about its going concern - The company's financial statements have been prepared assuming it will continue as a going concern. However, management has identified substantial doubt about its ability to do so for one year after the financial statements are issued, citing its current cash position of $60.2 million, historical net losses, and forecasted negative cash flows. The company's continuation is dependent on raising additional capital[21][22] Condensed Balance Sheet Data (Unaudited) | (in thousands) | June 30, 2022 | December 31, 2021 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $60,244 | $90,255 | | Total current assets | $61,264 | $90,789 | | Total assets | $65,044 | $94,347 | | Liabilities & Stockholders' Equity | | | | Total current liabilities | $8,938 | $11,824 | | Total liabilities | $9,317 | $12,743 | | Total stockholders' equity | $55,727 | $81,604 | | Total liabilities and stockholders' equity | $65,044 | $94,347 | Condensed Statements of Operations (Unaudited) | (in thousands, except per share data) | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :--- | :--- | :--- | :--- | :--- | | Revenue | $75 | $0 | $75 | $1,056 | | Research and development expense | $7,973 | $10,167 | $17,577 | $21,315 | | General and administrative expense | $5,455 | $4,237 | $10,511 | $8,425 | | Loss from operations | $(13,353) | $(14,404) | $(28,013) | $(28,684) | | Net loss | $(13,268) | $(14,399) | $(27,921) | $(28,673) | | Net loss per share (basic and diluted) | $(0.25) | $(0.28) | $(0.53) | $(0.56) | Condensed Statements of Cash Flows (Unaudited) | (in thousands) | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(29,929) | $(27,737) | | Net cash used in investing activities | $(82) | $(8) | | Net cash provided by financing activities | $0 | $9,564 | | Net change in cash and cash equivalents | $(30,011) | $(18,181) | | Cash and cash equivalents, end of period | $60,244 | $118,854 | Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses the clinical-stage biotech's uproleselan focus, noting R&D decrease, G&A increase, cash into Q3 2023, and substantial doubt about its going concern - The company is a clinical-stage biotechnology firm focused on developing novel glycomimetic drugs. Its lead candidate, uproleselan, is an E-selectin inhibitor being evaluated in a Phase 3 trial for relapsed/refractory Acute Myeloid Leukemia (AML). Top-line data from this trial is anticipated in mid-year 2023[86][88] - The company's existing cash and cash equivalents of $60.2 million are projected to be sufficient to fund operations into the third quarter of 2023. This forecast does not include potential proceeds from new financing or business development activities[98][99][136] - Management confirms there is substantial doubt about the company's ability to continue as a going concern beyond one year from the report's issuance date without obtaining additional financing. This is due to the current cash position and forecasted negative cash flows from ongoing product development[134][135] Comparison of Results of Operations (Six Months Ended June 30) | (in thousands) | 2022 | 2021 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Revenue | $75 | $1,056 | $(981) | (93)% | | Research and development expense | $17,577 | $21,315 | $(3,738) | (18)% | | General and administrative expense | $10,511 | $8,425 | $2,086 | 25% | | Net loss | $(27,920) | $(28,673) | $753 | (3)% | - The decrease in R&D expense was primarily driven by lower clinical trial costs for the uproleselan Phase 3 trial after patient enrollment concluded in October 2021. This was partially offset by increased manufacturing costs for uproleselan validation batches and toxicity studies for GMI-1687[117][122] - The increase in G&A expense was mainly due to commercial start-up expenses for uproleselan and higher patent fees. Personnel costs also rose with the hiring of a Chief Commercial Officer in February 2022[119] Quantitative and Qualitative Disclosures about Market Risk The company's primary market risk is interest rate sensitivity related to its $60.2 million in cash and cash equivalents, held in interest-bearing money market accounts - The company's main market risk exposure is from interest rate changes affecting its cash and cash equivalents of $60.2 million. An immediate 1% (100 basis point) change in interest rates is not expected to have a material effect on the fair value of these holdings[143] Controls and Procedures Management evaluated the company's disclosure controls and procedures as of June 30, 2022, concluding they were effective at a reasonable assurance level - Based on an evaluation as of June 30, 2022, the Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective at the reasonable assurance level[146] - There were no material changes to the company's internal controls over financial reporting during the fiscal quarter ended June 30, 2022[147] PART II. OTHER INFORMATION Legal Proceedings The company is not currently a party to any material legal proceedings and is unaware of any pending actions that could materially affect its business - As of the report date, the company is not involved in any material legal proceedings[148] Risk Factors The company faces a new material risk of Nasdaq delisting due to non-compliance with the minimum bid price, with a deadline of November 28, 2022, to regain compliance - On May 31, 2022, the company received a notice from Nasdaq for non-compliance with the minimum bid price requirement of $1.00 per share[151] - The company has a 180-day period, until November 28, 2022, to regain compliance by having its common stock closing bid price at or above $1.00 for at least ten consecutive business days[151] - Failure to regain compliance could result in the delisting of the company's common stock from the Nasdaq Global Market, which would likely harm the stock's liquidity and price, and could make it more difficult to raise capital[152] Unregistered Sales of Equity Securities and Use of Proceeds The company reported no unregistered sales of equity securities during the period covered by this report - There were no unregistered sales of equity securities during the quarter[153] Exhibits This section lists the exhibits filed with the quarterly report, including certifications by the Principal Executive Officer and Principal Financial Officer and XBRL data files