CBIO 10-Q
Crescent Biopharma, Inc. (CBIO)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark one)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission File Number
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(Address of principal executive offices) | (Zip Code) |
(
(Registrant’s telephone number, including area code)
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(Former name, former address and former fiscal year, if changed since last report)
Securities registered pursuant to Section 12(b) of the Act:
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large Accelerated Filer ☐ Accelerated Filer ☐Smaller Reporting Company
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Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Securities Exchange Act of 1934). Yes
The number of outstanding shares of the registrant’s common stock, par value $0.001 per share, as of the close of business on May 12, 2025 was
GLYCOMIMETICS, INC.
INDEX TO FORM 10-Q
Part I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
GLYCOMIMETICS, INC.
Balance Sheets
March 31, | December 31, | |||||
2025 | 2024 | |||||
Assets |
| (Unaudited) |
| |||
Current assets: | ||||||
Cash and cash equivalents | $ | | $ | | ||
Prepaid expenses and other current assets |
| |
| | ||
Total current assets |
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Total assets | $ | | $ | | ||
Liabilities & stockholders’ equity | ||||||
Current liabilities: | ||||||
Accounts payable | $ | | $ | | ||
Accrued expenses |
| |
| | ||
Lease liabilities |
| — |
| | ||
Total current liabilities |
| |
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Total liabilities |
| |
| | ||
Stockholders’ equity: | ||||||
Preferred stock; $ |
|
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Common stock; $ |
| |
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Additional paid-in capital |
| |
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Accumulated deficit |
| ( |
| ( | ||
Total stockholders’ equity |
| |
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Total liabilities and stockholders’ equity | $ | | $ | | ||
The accompanying notes are an integral part of the unaudited financial statements.
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GLYCOMIMETICS, INC.
Unaudited Statements of Operations and Comprehensive Loss
Three Months Ended March 31, | ||||||
2025 | 2024 | |||||
Costs and expenses: | ||||||
Research and development expense |
| |
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General and administrative expense |
| |
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Total costs and expenses |
| |
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Loss from operations |
| ( |
| ( | ||
Other income | ||||||
Interest income |
| |
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Net loss and comprehensive loss | $ | ( | $ | ( | ||
Basic and diluted net loss per common share | $ | ( | $ | ( | ||
Basic and diluted weighted-average number of common shares outstanding |
| |
| | ||
The accompanying notes are an integral part of the unaudited financial statements.
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GLYCOMIMETICS, INC.
Unaudited Statements of Stockholders’ Equity
Additional |
| Total | ||||||||||||
Common Stock | Paid-In | Accumulated | Stockholders’ | |||||||||||
| Shares |
| Amount |
| Capital |
| Deficit | Equity | ||||||
Balance at December 31, 2024 |
| | $ | | $ | | $ | ( | $ | | ||||
Vesting of restricted stock units |
| |
| |
| ( |
| — |
| — | ||||
Stock-based compensation | — | — | | — | | |||||||||
Net loss |
| — |
| — |
| — |
| ( |
| ( | ||||
Balance at March 31, 2025 |
| | $ | | $ | | $ | ( | $ | | ||||
Additional |
| Total | ||||||||||||
| Common Stock | Paid-In | Accumulated | Stockholders’ | ||||||||||
| Shares |
| Amount |
| Capital |
| Deficit | Equity | ||||||
Balance at December 31, 2023 |
| | $ | | $ | | $ | ( | $ | | ||||
Issuance of common stock for services |
| |
| |
| |
| — |
| | ||||
Exercise of options and vesting of restricted stock units |
| |
| |
| |
| — |
| | ||||
Stock-based compensation | — |
| — |
| |
| — |
| | |||||
Net loss | — |
| — |
| — |
| ( |
| ( | |||||
Balance at March 31, 2024 | | $ | | $ | | $ | ( | $ | | |||||
The accompanying notes are an integral part of the unaudited financial statements.
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GLYCOMIMETICS, INC.
Unaudited Statements of Cash Flows
Three Months Ended March 31, | ||||||
| 2025 |
| 2024 | |||
Operating activities | ||||||
Net loss | $ | ( | $ | ( | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||
Depreciation |
| — |
|
| | |
Non-cash lease expense | — | | ||||
Issuance of common stock for services | — | | ||||
Stock-based compensation |
| |
| | ||
Changes in assets and liabilities: | ||||||
Prepaid expenses and other current assets |
| ( |
| | ||
Prepaid research and development expenses | — | | ||||
Accounts payable |
| ( |
| ( | ||
Accrued expenses |
| ( |
| ( | ||
Lease liabilities | ( | ( | ||||
Net cash used in operating activities |
| ( |
| ( | ||
Investing activities | ||||||
Purchases of property and equipment |
| — |
| ( | ||
Net cash used in investing activities |
| — |
| ( | ||
Financing activities | ||||||
Proceeds from exercise of stock options |
| — |
| | ||
Net cash provided by financing activities |
| — |
| | ||
Net change in cash and cash equivalents |
| ( |
| ( | ||
Cash and cash equivalents, beginning of period |
| |
| | ||
Cash and cash equivalents, end of period | $ | | $ | | ||
The accompanying notes are an integral part of the unaudited financial statements.
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GLYCOMIMETICS, INC.
Notes to Unaudited Financial Statements
1. Description of the Business
GlycoMimetics, Inc. (the Company), a Delaware corporation, was incorporated in 2003. The Company was previously developing a pipeline of proprietary glycomimetics, which are small molecules that mimic the structure of carbohydrates involved in important biological processes, to inhibit disease-related functions of carbohydrates such as the roles they play in cancers and inflammation. In July 2024, following feedback from the U.S. Food and Drug Administration (FDA), the Company determined that the regulatory path forward for its lead product candidate, uproleselan, for the treatment of relapsed and refractory acute myeloid leukemia would require an additional clinical trial. The decision to not conduct an additional clinical trial did not relate to any safety or medical issues or negative regulatory feedback related to the Company’s programs. In order to conserve its cash resources, in July 2024 the Company reduced its workforce by approximately
Following the strategic review, on October 28, 2024 the Company entered into an Agreement and Plan of Merger and Reorganization (the Merger Agreement) with Crescent Biopharma, Inc., a Delaware corporation (Crescent), pursuant to which Crescent will become a wholly owned subsidiary of the Company (the Merger). Upon completion of the Merger, the Company plans to operate under the name Crescent Biopharma, Inc. The Merger is expected to close in the second quarter of 2025, subject to certain closing conditions, including, among other things, approval by the stockholders of each company and the satisfaction of customary closing conditions.
Concurrently with the execution and delivery of the Merger Agreement, certain institutional and accredited investors have entered into a securities purchase agreement (the Purchase Agreement) with the Company, pursuant to which they have agreed, subject to the terms and conditions of such agreements, to purchase, immediately following the consummation of the Merger, shares of the Company’s common stock and pre-funded warrants (together, the PIPE Securities) for an aggregate purchase price of approximately $
Pursuant to the exchange ratio formula set forth in the Merger Agreement, upon the closing of the Merger (but prior to closing of the Private Placement described below), on a pro forma basis and based upon the number of shares of common stock of the Company expected to be issued in the Merger, pre-Merger Crescent stockholders will own approximately
2. Going Concern
The accompanying unaudited financial statements have been prepared assuming that the Company will continue as a going concern within one year after the date that the financial statements are issued. During 2024, the Company incurred a net loss of $
If the contemplated Merger and Private Placement does not close by the third quarter of 2025, the Company may seek other strategic alternatives or liquidate.
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The accompanying financial statements do not include any adjustments that might be necessary if the Company is not able to continue as a going concern.
3. Significant Accounting Policies
There have been no material changes to the significant accounting policies previously disclosed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the United States Securities and Exchange Commission (the SEC) on February 13, 2025 (the Form 10-K).
Basis of Accounting
The accompanying unaudited financial statements were prepared based on the accrual method of accounting in accordance with U.S. generally accepted accounting principles (GAAP).
Unaudited Financial Statements
The accompanying balance sheet as of March 31, 2025, statements of operations and comprehensive loss and stockholders’ equity for the three months ended March 31, 2025 and 2024 and statements of cash flows for the three months ended March 31, 2025 and 2024 are unaudited. These unaudited financial statements have been prepared in accordance with the rules and regulations of the SEC for interim financial information. Accordingly, they do not include all of the information and footnotes required by GAAP for complete annual financial statements. These unaudited financial statements should be read in conjunction with the audited financial statements and the accompanying notes for the year ended December 31, 2024 contained in the Form 10-K. The unaudited interim financial statements have been prepared on the same basis as the annual financial statements and in the opinion of management reflect all adjustments (consisting of normal recurring adjustments) necessary to state fairly the Company’s financial position as of March 31, 2025, its results of operations and changes in its stockholders’ equity for the three months ended March 31, 2025 and 2024 and its cash flows for the three months ended March 31, 2025 and 2024. The December 31, 2024 balance sheet included herein was derived from audited financial statements, but does not include all disclosures including notes required by GAAP for complete annual financial statements. The financial data and other information disclosed in these notes to the financial statements related to the three months ended March 31, 2025 and 2024 are unaudited. Interim results are not necessarily indicative of results for an entire year or for any future period.
4. Net Loss Per Share of Common Stock
Basic net loss per common share is determined by dividing net loss by the weighted-average number of common shares outstanding during the period, without consideration of common stock equivalents. Diluted net loss per share is computed by dividing net loss by the weighted-average number of common stock equivalents outstanding for the period. The treasury stock method is used to determine the dilutive effect of the Company’s stock options and restricted stock units (RSUs).
The following potentially dilutive securities outstanding have been excluded from the computation of diluted weighted-average common shares outstanding, as they would be anti-dilutive:
Three Months Ended March 31, | |||
2025 |
| 2024 | |
Stock options and RSUs | |
| |
5. Prepaid Expenses and Other Current Assets
The following is a summary of the Company’s prepaid expenses and other current assets:
March 31, | December 31, | |||||
| 2025 |
| 2024 | |||
Prepaid expenses | $ | | $ | | ||
Other current assets |
| |
| | ||
Prepaid expenses and other current assets | $ | | $ | | ||
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6. Accrued Expenses
The following is a summary of the Company’s accrued expenses:
| March 31, | December 31, | ||||
| 2025 |
| 2024 | |||
Accrued research and development expenses | $ | | $ | | ||
Accrued consulting and other professional fees |
| |
| | ||
Accrued employee benefits |
| |
| | ||
Accrued retention | | | ||||
Accrued severance | | | ||||
Accrued expenses | $ | | $ | | ||
7. Operating Leases
The Company previously leased office and research space in Rockville, Maryland under an operating lease. During the year ended December 31, 2024, the Company abandoned the leased space and recognized an impairment charge of approximately $
The components of lease expense and related cash flows were as follows:
Three Months Ended March 31, | ||||||
|
| 2025 |
| 2024 | ||
Operating lease cost | $ | | $ | | ||
Variable lease cost | | | ||||
Total operating lease cost | $ | | $ | | ||
| ||||||
Cash paid for amounts included in the measurement of lease liabilities: | ||||||
Operating cash outflows for operating leases | $ | | $ | | ||
8. Stockholders’ Equity
Common Stock
During the year ended December 31, 2024, the Company’s board of directors adopted, and its stockholders approved, an increase in the total authorized shares of common stock from
At-The-Market Sales Facility
In March 2022, the Company filed a shelf registration statement with the SEC, which was declared effective on April 22, 2022. On April 28, 2022, the Company entered into an at-the-market sales agreement (the Sales Agreement) with Cowen and Company, LLC. Under the Sales Agreement, the Company may sell up to $
9. Stock-based Compensation
2013 Equity Incentive Plan
The Company’s board of directors adopted, and its stockholders approved, its 2013 Equity Incentive Plan effective in January 2014, and the 2013 Equity Incentive Plan was amended and restated by approval of the board of directors in April 2022 and by approval of the stockholders in May 2022 (as so amended and restated, the 2013 Plan). The 2013 Plan provides for the grant of incentive stock options, within the meaning of Section 422 of the Internal Revenue Code (the Code), to the Company’s employees and its parent and subsidiary corporations’ employees, and for the grant of nonstatutory stock options, restricted stock awards, restricted stock unit awards (RSUs), stock appreciation rights, performance stock awards and other forms of stock compensation to its employees, including officers, consultants and
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directors. The 2013 Plan also provides for the grant of performance cash awards to the Company’s employees, consultants and directors. Unless otherwise stated in a stock option agreement,
Authorized Shares
The maximum number of shares of common stock that may be issued under the 2013 Plan was originally
Shares issued under the 2013 Plan may be authorized but unissued or reacquired shares of common stock. Shares subject to stock awards granted under the 2013 Plan that expire or terminate without being exercised in full, or that are paid out in cash rather than in shares, will not reduce the number of shares available for issuance under the 2013 Plan. Additionally, shares issued pursuant to stock awards under the 2013 Plan that the Company repurchases or that are forfeited, as well as shares reacquired by the Company as consideration for the exercise or purchase price of a stock award or to satisfy tax withholding obligations related to a stock award, will become available for future grant under the 2013 Plan.
Stock Options
A summary of the Company’s stock option activity under the 2013 Plan for the three months ended March 31, 2025 is as follows:
Weighted-Average | ||||||||||
| Remaining | Aggregate | ||||||||
Outstanding | Weighted-Average | Contractual Term | Intrinsic Value | |||||||
| Options |
| Exercise Price |
| (Years) |
| (In thousands) | |||
Outstanding as of December 31, 2024 | | $ | |
|
| |||||
Options forfeited | ( | | ||||||||
Outstanding as of March 31, 2025 | |
| |
| $ | — | ||||
Vested or expected to vest as of March 31, 2025 | |
| |
| $ | — | ||||
Exercisable as of March 31, 2025 | |
| |
| $ | — | ||||
As of March 31, 2025, there was approximately $
The Company has granted stock options to purchase an aggregate of
10
Restricted Stock Units (RSUs)
An RSU is a stock award that entitles the holder to receive shares of the Company’s common stock as the award vests. The fair value of each RSU is based on the closing price of the Company’s common stock on the date of grant. In January 2021, the Company awarded RSUs under the 2013 Plan to all of its employees. The RSUs vested over
The following is a summary of RSU activity under the 2013 Plan for the three months ended March 31, 2025:
Weighted-Average | ||||||
Number of Shares | Grant Date | |||||
| Underlying RSUs | Fair Value | ||||
Unvested at December 31, 2024 |
| | $ | | ||
Vested |
| ( |
| | ||
Unvested at March 31, 2025 |
| — |
| — | ||
Inducement Plan
The Company’s board of directors previously adopted the GlycoMimetics, Inc. Inducement Plan (as amended to date, the Inducement Plan). The Inducement Plan provides for the grant of nonstatutory stock options, restricted stock awards, RSU awards, stock appreciation rights and other forms of stock awards to individuals not previously an employee or director of the Company as an inducement for such individuals to join the Company. Unless otherwise stated in an applicable stock option agreement, -fourth of the shares subject to an option grant under the Inducement Plan will typically vest upon the first anniversary of the vesting start date, with the balance of the shares vesting in a series of
A summary of the Company’s stock option activity under the Inducement Plan for the three months ended March 31, 2025 is as follows:
Weighted-Average | ||||||||||
| Remaining | Aggregate | ||||||||
Outstanding | Weighted-Average | Contractual Term | Intrinsic Value | |||||||
| Options |
| Exercise Price |
| (Years) |
| (In thousands) | |||
Outstanding as of December 31, 2024 | | $ | |
|
| |||||
Options forfeited | ( | | ||||||||
Outstanding as of March 31, 2025 | |
| |
| $ | — | ||||
Vested or expected to vest as of March 31, 2025 | |
| |
| $ | — | ||||
Exercisable as of March 31, 2025 | |
| |
| $ | — | ||||
As of March 31, 2025, there was approximately $
The Company has granted stock options to purchase an aggregate of
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fair value of $
The weighted-average fair value of the options granted under all equity incentive plans during the three months ended March 31, 2024 was $
| 2024 | |
Expected term | ||
Expected volatility | ||
Risk-free interest rate | ||
Expected dividend yield |
Stock-based compensation expense was classified on the statements of operations as follows for the three months ended March 31, 2025 and 2024:
Three Months Ended March 31, | ||||||
| 2025 | 2024 | ||||
Research and development expense | $ | — | $ | | ||
General and administrative expense |
| |
| | ||
Total stock-based compensation expense | $ | | $ | | ||
10. Income Taxes
The Company did not record any tax provision or benefit for the three months ended March 31, 2025 and 2024. The Company has provided a valuation allowance for the full amount of its net deferred tax assets since realization of any future benefit from deductible temporary differences, net operating loss carryforwards and research and development credits is not more-likely-than-not to be realized at March 31, 2025 and December 31, 2024.
11. License and Collaboration Agreements
Apollomics
In 2020, the Company entered into a collaboration and license agreement (the Agreement) with Apollomics (Hong Kong), Limited (Apollomics) for the development, manufacture and commercialization of products derived from two of the Company’s compounds, GMI-1271 and GMI-1687 (the Products) for therapeutic and prophylactic uses (the Field) in China, Taiwan, Hong Kong and Macau (the Territory). Under the terms of the Agreement, the Company granted Apollomics:
| ● | an exclusive license, with the right to sublicense, to develop, manufacture and have manufactured, distribute, market, promote, sell, have sold, offer for sale, import, label, package and otherwise the Products in the Field in the Territory; and |
| ● | a non-exclusive license to conduct preclinical research with respect to Products in the Field outside of the Territory for the purposes of developing such Products for use in the Territory. |
The Company did not recognize any milestone revenue under the Agreement for the three months ended March 31, 2025 or 2024. During the three months ended March 31, 2025 Apollomics exercised its right to terminate the Agreement, which will be effective May 21, 2025.
12. Restructuring and Assets Impairment Charges
In July 2024, the Company’s Board of Directors approved a streamlined operating plan that included a reduction in the Company’s workforce by approximately
Employees were entitled to receive severance payments and Company-funded medical insurance for a specific time. During the year ended December 31, 2024, the Company recognized $
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The following is a summary of the activity for accrued severance costs for the three months ended March 31, 2025:
| 2025 | ||
Severance accrual, January 1 | $ | | |
Cash payments |
| ( | |
Severance accrual, March 31 | $ | | |
The accrued severance liability of $
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ITEM 2. | MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
Certain statements contained in this Quarterly Report on Form 10-Q may constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words or phrases “would be,” “will allow,” “intends to,” “will likely result,” “are expected to,” “will continue,” “is anticipated,” “estimate,” “project,” or similar expressions, or the negative of such words or phrases, are intended to identify “forward-looking statements.” We have based these forward-looking statements on our current expectations and projections about future events. Because such statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to these differences include those below and elsewhere in this Quarterly Report on Form 10-Q, our Annual Report on Form 10-K, particularly in Part I – Item 1A, “Risk Factors,” and our other filings with the Securities and Exchange Commission. Statements made herein are as of the date of the filing of this Form 10-Q with the Securities and Exchange Commission and should not be relied upon as of any subsequent date. Unless otherwise required by applicable law, we do not undertake, and we specifically disclaim, any obligation to update any forward-looking statements to reflect occurrences, developments, unanticipated events or circumstances after the date of such statement.
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited financial statements and related notes that appear in Item 1 of this Quarterly Report on Form 10-Q and with our audited financial statements and related notes for the year ended December 31, 2024, which are included in our Annual Report on Form 10-K filed with the SEC on February 13, 2025.
Overview
We are a biotechnology company that was previously developing a pipeline of proprietary glycomimetics, which are small molecules that mimic the structure of carbohydrates involved in important biological processes, to inhibit disease-related functions of carbohydrates such as the roles they play in cancers and inflammation. Our previous lead glycomimetic drug candidate, uproleselan, is a specific E-selectin antagonist that we were developing to be used in combination with chemotherapy to treat patients with acute myeloid leukemia, or AML, a life-threatening hematologic cancer, and potentially other hematologic cancers. We conducted a randomized, double-blind, placebo-controlled Phase 3 pivotal clinical trial to evaluate uproleselan in individuals with relapsed/refractory (R/R) AML. In May 2024, we reported topline results from the Phase 3 trial, in which uproleselan combined with chemotherapy did not achieve a statistically significant improvement in overall survival in the intent to treat (ITT) population versus chemotherapy alone. In June 2024, we announced comprehensive results of the Phase 3 trial.
Following the announcement of the data from the Phase 3 trial, we requested and held a meeting with the FDA to discuss whether any of the results summarized above could serve as a basis for a submission for regulatory approval. Based on the feedback received, we concluded that any potential regulatory path for uproleselan in this patient population would require an additional clinical trial, the conduct of which would require capital resources beyond those available to us. The decision to not conduct an additional clinical trial did not relate to any safety or medical issues or negative regulatory feedback related to our programs.
In July 2024, following the announcement of the data from our Phase 3 pivotal trial and our discussions with the FDA, we announced that we would initiate a review of strategic alternatives focused on maximizing stockholder value, which could include, but are not limited to, a merger, sale, divestiture of assets, licensing, or other strategic transaction. We also reduced our workforce by approximately 80% in the third quarter of 2024 in order to conserve our cash resources as part of a streamlined operating plan while we undertook our strategic review.
We also previously entered into a Cooperative Research and Development Agreement, or CRADA, with the National Cancer Institute, or NCI, part of the National Institutes of Health, to conduct a Phase 2/3 randomized, controlled clinical trial testing the addition of uproleselan to a standard chemotherapy regimen. On October 29, 2024 we announced data from the Phase 2 portion of the trial showing no statistically significant improvement in event-free survival (EFS) for patients receiving uproleselan in combination with chemotherapy versus chemotherapy alone.
Following these outcomes of our clinical trials and regulatory discussions we do not currently intend to continue development of uproleselan or any of our other drug candidates. We currently do not have any ongoing clinical trials.
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The Merger Agreement
Following the strategic review described above, on October 28, 2024 we entered into the Merger Agreement with Crescent, a privately held biotechnology company advancing a pipeline of oncology therapeutics designed to treat solid tumors, pursuant to which Crescent will become a wholly owned subsidiary of us and we will operate under the name Crescent Biopharma, Inc. following the Merger. We anticipate that the Merger will close in the late second quarter of 2025, subject to certain closing conditions, along with the concurrent Private Placement. For additional information about the Merger and the concurrent Private Placement, see Note 1 to the financial statements included in this report. Following the Merger, the current business of Crescent will become the primary business of our company.
Based on our current operating plan, we expect that our current cash and cash equivalents will fund our operations until the closing of the contemplated Merger, which is subject to approval by our stockholders and the stockholders of Crescent and other customary closing conditions; however, we have based this estimate on assumptions that may prove to be wrong, and we could use our capital resources sooner than we expect. If the contemplated Merger and Private Placement does not close by the third quarter of 2025, the Company may seek other strategic alternatives or liquidate.
Critical Accounting Policies and Significant Judgments and Estimates
Our management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States, or GAAP. The preparation of these financial statements requires us to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities as of the dates of the balance sheets and the reported amounts of revenue and expenses during the reporting periods. In accordance with GAAP, we base our estimates on historical experience and on various other assumptions that we believe are reasonable under the circumstances at the time such estimates are made. Actual results may differ materially from our estimates and judgments under different assumptions or conditions. We periodically review our estimates in light of changes in circumstances, facts and experience. The effects of material revisions in estimates are reflected in our financial statements prospectively from the date of the change in estimate.
We define our critical accounting policies as those accounting principles generally accepted in the United States that require us to make subjective estimates and judgments about matters that are uncertain and are likely to have a material impact on our financial condition and results of operations, as well as the specific manner in which we apply those principles. For a description of our critical accounting policies and estimates, please see the disclosures in Part II, Item 7 of our Annual Report on Form 10-K for the year ended December 31, 2024. There have not been any material changes to our critical accounting policies and estimates since December 31, 2024.
Components of Operating Results
Revenue
We have not generated any revenue from the sale of our drug candidates and do not expect to generate any revenue from the sale of drugs in the near future. Substantially all of our historical revenue consisted of upfront and milestone payments under license and collaboration agreements. We do not expect to recognize revenue in the future under any current license or collaboration agreement.
Research and Development
Research and development expenses have consisted of expenses incurred in performing research and development activities, including compensation and benefits for full-time research and development employees, facilities expenses, overhead expenses, cost of laboratory supplies, clinical trial and related clinical manufacturing expenses, fees paid to CROs and other consultants and other outside expenses. Other preclinical research and platform programs have included activities related to exploratory efforts, target validation, lead optimization for our earlier programs and our proprietary glycomimetics platform.
We have not utilized a formal time allocation system to capture expenses on a project-by-project basis because we were organized and recorded expense by functional department and our employees allocated time to more than one development project. Accordingly, we have only allocated a portion of our research and development expenses by functional area and by drug candidate.
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Research and development costs are expensed as incurred. Non-refundable advance payments for goods or services to be received in the future for use in research and development activities were deferred and capitalized. The capitalized amounts are expensed as the related goods are delivered or the services are performed.
General and Administrative
General and administrative expenses have consisted primarily of salaries and other related costs, including stock-based compensation, for personnel in executive, finance, accounting, business development and human resources functions. Other significant costs include facility costs not otherwise included in research and development expenses, legal fees relating to patent and corporate matters and fees for accounting and consulting services.
Interest Income
Interest income consists of interest income earned on our cash and cash equivalents.
Results of Operations for the Three Months Ended March 31, 2025 and 2024
The following table sets forth our results of operations:
Three Months Ended March 31, | Increase/(Decrease) | |||||||||||
(dollars in thousands) |
| 2025 |
| 2024 |
|
| ||||||
Costs and expenses: | ||||||||||||
Research and development expense | $ | 15 | $ | 6,025 | $ | (6,010) | (100) | % | ||||
General and administrative expense |
| 2,384 |
| 5,090 |
| (2,706) | (53) | % | ||||
Total costs and expenses |
| 2,399 |
| 11,115 |
| (8,716) | (78) | % | ||||
Loss from operations |
| (2,399) |
| (11,115) |
| 8,716 | 78 | % | ||||
Other income | ||||||||||||
Interest income |
| 55 |
| 378 |
| (323) | (85) | % | ||||
Total other income | 55 | 378 | (323) | (85) | % | |||||||
Net loss and comprehensive loss | $ | (2,344) | $ | (10,737) | $ | 8,393 | 78 | % | ||||
The decrease in research and development expense of $6.0 million was primarily due to our winding down of operations beginning in June 2024 following the results from our clinical trials.
The decrease in general and administrative expense of $2.7 million was primarily due to lower personnel-related expenses and professional fees from our winding down of operations beginning in June 2024.
Interest Income
During the three months ended March 31, 2025 interest income decreased by $323,000 due to lower invested cash and cash equivalent balances in the first quarter of 2025 as compared to 2024.
Liquidity and Capital Resources
Sources of Liquidity
We historically financed our operations primarily through public offerings and private placements of our capital stock, including at-the-market equity sales agreements and upfront and milestone payments from our license and collaboration agreements. As of March 31, 2025, we had $5.6 million in cash and cash equivalents. Based on our current operating plan, we expect that our current cash and cash equivalents will fund our operations until the closing of the Merger, which is subject to approval by our stockholders and the stockholders of Crescent and other customary closing conditions; however, we have based this estimate on assumptions that may prove to be wrong, and we could use our capital resources sooner than we expect. If we are unable to close the Merger or raise additional capital, we will need to eliminate some or all of our operations or liquidate our company. The Private Placement is subject to the satisfaction or waiver of the closing conditions of the Merger and would close immediately following the closing of the Merger.
In March 2022, we filed a shelf registration statement with the SEC, which was declared effective on April 22, 2022. In April 2022, we entered into an at-the-market sales agreement, or the Sales Agreement, with Cowen and Company. Under the Sales Agreement, we may sell up to $100.0 million in shares of our common stock. There were no shares sold in the year ended December 31, 2024 or the three months ended March 31, 2025. As of March 31, 2025, $66.0 million remained available to be sold under the Sales Agreement, although we have no current plans to sell
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additional shares under the Sales Agreement prior to the closing of the Merger, and the shelf registration expired on April 28, 2025.
Funding Requirements
Our primary uses of capital were historically compensation and related expenses, third-party clinical research and development services, clinical costs, legal and other regulatory expenses and general overhead costs. Now that we have suspended all of our research and development activities in anticipation of the Merger with Crescent, our operations will be limited and we expect that our expenses will decrease significantly.
Going Concern
The accompanying unaudited financial statements have been prepared assuming that we will continue as a going concern within one year after the date that the financial statements are issued. During 2024, we incurred a net loss of $37.9 million and had net cash flows used in operating activities of $31.1 million. During the three months ended March 31, 2025, we incurred a net loss of $2.3 million and had net cash flows used in operating activities of $5.1 million. At March 31, 2025, we had $5.6 million in cash and cash equivalents and had no committed source of additional funding other than the expected Private Placement. Management believes that given our current cash position and forecasted negative cash flows from operating activities over the next twelve months, there is substantial doubt about our ability to continue as a going concern after the date that is one year from the date that these financial statements are issued without the closing of the contemplated Merger and Private Placement.
If the contemplated Merger and Private Placement does not close by the third quarter of 2025, we may seek other strategic alternatives or liquidate.
Cash Flows
The following is a summary of our cash flows for the three months ended March 31, 2025 and 2024:
Three Months Ended March 31, | ||||||
(in thousands) | 2025 | 2024 | ||||
Net cash used in: |
|
| ||||
Operating activities | $ | (5,106) | $ | (10,509) | ||
Investing activities |
| — |
| (7) | ||
Financing activities |
| — |
| 5 | ||
Net change in cash and cash equivalents | $ | (5,106) | $ | (10,511) | ||
Operating Activities
Net cash used in operating activities was $5.1 million for the three months ended March 31, 2025 compared to $10.5 million for the three months ended March 31, 2024. The decrease is due to our winding down of operations beginning in June 2024 following the results from our clinical trials.
Investing Activities
Net cash used in investing activities for the three months ended March 31, 2024 was for computer and laboratory equipment.
Financing Activities
Net cash provided by financing activities during the three months ended March 31, 2024 consisted of proceeds received from stock option exercises.
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ITEM 3. | QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK |
We are a smaller reporting company as defined by Item 10 of Regulation S-K and are not required to provide the information otherwise required under this item.
ITEM 4. CONTROLS AND PROCEDURES
(a) Evaluation of Disclosure Controls and Procedures
The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act, refers to controls and procedures that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that such information is accumulated and communicated to a company’s management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure.
In designing and evaluating our disclosure controls and procedures, management recognizes that disclosure controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the disclosure controls and procedures are met. Additionally, in designing disclosure controls and procedures, our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible disclosure controls and procedures. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate.
Our Principal Executive Officer and Principal Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures as of March 31, 2025, the end of the period covered by this Quarterly Report on Form 10-Q. Based upon such evaluation, our Principal Executive Officer and Principal Financial Officer has concluded that our disclosure controls and procedures were effective as of such date at the reasonable assurance level.
(b) Changes in Internal Controls Over Financial Reporting
There have not been any changes in our internal controls over financial reporting during our fiscal quarter ended March 31, 2025 that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
From time to time, we are subject to litigation and claims arising in the ordinary course of business. We are not currently a party to any material legal proceedings and we are not aware of any pending or threatened legal proceeding against us that we believe could have a material adverse effect on our business, operating results, cash flows or financial condition.
ITEM 1A. RISK FACTORS
Our business is subject to risks and events that, if they occur, could adversely affect our financial condition and results of operations and the trading price of our securities. Our risk factors as of the date of this quarterly report on Form 10-Q have not changed materially from those described in “Part I, Item 1A. Risk Factors” of our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the SEC on February 13, 2025.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
None.
ITEM 5. OTHER INFORMATION
During the three months ended March 31, 2025, none of our directors and officers (as defined in Rule 16a-1(f) under the Securities Exchange Act of 1934, as amended)
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Exhibit | Document | |
|---|---|---|
10.4 | ||
10.5 | ||
31.1* | ||
32.1** | ||
101.INS | XBRL Instance Document (the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the inline XBRL document) | |
101.SCH | Inline XBRL Taxonomy Extension Schema with Embedded Linkbase Documents | |
104 | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) |
* Filed herewith.
** These certifications are being furnished solely to accompany this quarterly report pursuant to 18 U.S.C. Section 1350, and are not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and are not to be incorporated by reference into any filing of the registrant, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
GLYCOMIMETICS, INC. | |||
Date: May 14, 2025 | By: | /s/ Brian M. Hahn | |
Brian M. Hahn | |||
Principal Executive and Financial Officer | |||
(On behalf of the Registrant and as Principal Executive Officer, Principal Financial Officer and Principal Accounting Officer) | |||
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