GLYCOMIMETICS INC
For the period ended Mar 31, 2025. Filed May 14, 2025.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2025 · Filed May 14, 2025
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-09-30; filed 2024-11-13.
0001558370-24-015537
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-03-31; filed 2025-05-14.
0001558370-25-007780
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 62 previous paragraphs and 49 current paragraphs.
24 unchanged; 15 reworded; 8 added; 20 removed; 3 previous and 2 current paragraphs rearranged.
Tables are not compared: 16 previous and 3 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (8)
Current report
Overview
Current report
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.
Current report
The Merger Agreement
Current report
The following table sets forth our results of operations:
Current report
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.
Current report
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.
Current report
If the contemplated Merger and Private Placement does not close by the third quarter of 2025, we may seek other strategic alternatives or liquidate.
Current report
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.
Removed paragraphs (20)
Previous report
Overview and Recent Developments
Previous report
In addition to uproleselan, we designed an innovative antagonist of E-selectin, GMI-1687, that could be a subcutaneously administered treatment. Initially developed as a potential life-cycle extension to uproleselan GMI-1687 was being developed to broaden the clinical usefulness of an E-selectin antagonist to conditions where outpatient treatment is preferred or required. We conducted a Phase 1a trial of GMI-1687 in healthy adult volunteers and have entered into a collaboration with Apollomics (Hong Kong) Limited for the development of GMI-1687, as well as uproleselan, in Mainland China, Hong Kong, Macau and Taiwan, also known as Greater China, but we are not otherwise actively developing GMI-1687.
Previous report
Should we resume development of our product candidates, the duration, costs and timing of clinical trials and development of our drug candidates would depend on a variety of factors that include:
Previous report
In addition, the probability of success for each drug candidate will depend on numerous factors, including competition, manufacturing capability and commercial viability. We will determine which programs to pursue and how much to fund each program in response to the scientific and clinical success of each drug candidate, as well as an assessment of each drug candidate’s commercial potential.
Previous report
The following tables set forth our results of operations for the three and nine months ended September 30, 2024 and 2023:
Previous report
Research and Development Expense
Previous report
The following tables summarize our research and development expense by functional area for the three and nine months ended September 30, 2024 and 2023:
Previous report
The following tables summarize our research and development expense by drug candidate for the three and nine months ended September 30, 2024 and 2023:
Previous report
Our research and development expense for the three and nine months ended September 30, 2024 decreased by $3.6 million and $0.8 million, respectively, compared to the same periods in 2023 primarily due to our winding down of operations following the results from our clinical trials. During 2023, we accrued amounts for the expected payments of year-end bonuses to employees; as no bonuses will be payable for the year ending December 31, 2024, we have not recorded any further accruals and reversed accruals made through April, 2024.
Previous report
General and Administrative Expense
Previous report
The following tables summarize the components of our general and administrative expense for the three and nine months ended September 30, 2024 and 2023:
Previous report
General and administrative expenses decreased by $0.5 million and $1.7 million for the three and nine months ended September 30, 2024, respectively as compared to the same periods in 2023. These decreases were primarily due to lower personnel-related expenses, including no bonus accruals for 2024. Professional expenses also decreased as a result of lower levels of commercial consulting services in 2024 compared to 2023. These decreases were offset by higher stock-based compensation expenses incurred 2024 as compared to 2023 due to a higher fair market value for shares issued in 2024 as compared to 2023 and company-wide retention grants of stock options in June 2024.
Previous report
Gain on Sale of Asset
Previous report
During the three months ended September 30, 2024, as part of our streamlining our operations, we sold the rights to rivipansel for proceeds of $1.2 million. As we had previously written down this asset to zero value in our financial statements, we recorded a gain on sale of asset equal to the net proceeds.
Previous report
Restructuring and Asset Impairment Charges
Previous report
During the three months ended September 30, 2024, we undertook a reduction in force of our headcount and incurrent $5.0 million of severance and related expenses. We also abandoned our leased office space and recorded $0.4 million of impairment charges related to the lease and accelerated depreciation on property and equipment.
Previous report
We entered into a collaboration and license agreement with Apollomics in 2020 and are potentially eligible to earn milestone payments and royalties under that agreement. However, our ability to earn milestone payments and potential royalty payments and their timing will be dependent upon the outcome of Apollomics’ activities and is therefore uncertain.
Previous report
As of September 30, 2024, our only contractual obligations consisted of the remaining rent obligation of $268,000 under a non-cancelable lease for office space with a term through January 2025.
Previous report
We have no other fixed long-term obligations and do not have significant capital expenditure requirements.
Previous report
Net cash used in operating activities for the nine months ended September 30, 2024 and 2023 was primarily the result of pre-commercialization efforts and clinical and manufacturing costs associated with our uproleselan clinical development programs. These cash expenses were offset by non-cash expenses for stock-based compensation, lease expense and depreciation.
Reworded paragraphs (15)
Previous wording
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 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.
Current wording
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.
Previous wording
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 order to conserve our cash resources as part of a streamlined operating plan while we undertook our strategic review.
Current wording
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.
Previous wording
We also have 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 of uproleselan being conducted by the NCI and the Alliance for Clinical Trials in Oncology in adults with newly diagnosed AML who are 60 years or older and fit for intensive chemotherapy. This study
Current wording
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.
Previous wording
Following the strategic review described above, on October 28, 2024 we entered into acquisition agreement, or the Merger Agreement, with Crescent Biopharma, Inc., or 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 such transaction, or the Merger. We anticipate that the Merger will close in the second quarter of 2025, subject to certain closing conditions, along with a concurrent private placement financing. For additional information about the Merger and the concurrent private placement financing, see Note 1 to the financial statements included in this report, as well as the Current Report on Form 8-K that we filed with the SEC on October 29, 2024. Following the Merger, the current business of Crescent will become the primary business of our company.
Current wording
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.
Previous wording
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; 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.
Current wording
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.
Previous wording
Our management’s discussion and analysis of our financial condition and results of operations are 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 materially differ 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.
Current wording
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.
Previous wording
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.
Current wording
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.
Previous wording
Results of Operations for the Three and Nine Months Ended September 30, 2024 and 2023
Current wording
Results of Operations for the Three Months Ended March 31, 2025 and 2024
Previous wording
During the three and nine months ended September 30, 2024, interest income decreased by $0.4 million and $1.0 million, respectively, due to lower invested cash and cash equivalent balances as compared to the same periods in 2023.
Current wording
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.
Previous wording
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 2022 Sales Agreement, with Cowen and Company. Under the 2022 Sales Agreement, we may sell up to $100.0 million in shares of our common stock. During the year ended December 31, 2022, we sold 1,953,854 shares of common stock under the 2022 Sales Agreement at a weighted average price of $2.22 per share, for aggregate net proceeds of $4.2 million, after deducting commissions and offering expenses. During the year ended December 31, 2023, we sold 9,822,930 shares of common stock under the 2022 Sales Agreement at a weighted average price of $3.01 per share, for aggregate net proceeds of $28.7 million, after deducting commissions and offering expenses. There were no shares sold in the nine months ended September 30, 2024. As of September 30, 2024, $66.0 million remained available to be sold under the 2022 Sales Agreement, although we have no current plans to sell additional shares under the 2022 Sales Agreement prior to the closing of the Merger.
Current wording
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
Previous wording
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 entering into the Merger with Crescent, our operations will be limited and we expect that our expenses will decrease significantly.
Current wording
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.
Previous wording
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. 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. At September 30, 2024, the Company had $14.4 million in cash and cash equivalents and had no committed source of additional funding from either debt or equity financings. Management believes that given the Company’s current cash position and forecasted negative cash flows from operating activities over the next twelve months, there is substantial doubt about its ability to continue as a going concern after the date that is one year from the date that these unaudited financial statements are issued. The Company expects that its current cash resources will only be sufficient to fund the Company’s operations through the closing of the contemplated Merger and Private Placement.
Current wording
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.
Previous wording
The following is a summary of our cash flows for the nine months ended September 30, 2024 and 2023:
Current wording
The following is a summary of our cash flows for the three months ended March 31, 2025 and 2024:
Previous wording
Net cash used in investing activities for the nine months ended September 30, 2024 and 2023 was for computer, office and laboratory equipment and was not material.
Current wording
Net cash used in investing activities for the three months ended March 31, 2024 was for computer and laboratory equipment.
Previous wording
Net cash provided by financing activities during the nine months ended September 30, 2024 consisted of proceeds received from stock option exercises. Net cash provided by financing activities during the nine months ended September 30, 2023 primarily consisted of the net proceeds received from sales of our common stock under the 2022 Sales Agreement of $28.7 million.
Current wording
Net cash provided by financing activities during the three months ended March 31, 2024 consisted of proceeds received from stock option exercises.
Rearranged current paragraphs (2)
Current report — wording carried from elsewhere
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.
Current report — wording carried from elsewhere
additional shares under the Sales Agreement prior to the closing of the Merger, and the shelf registration expired on April 28, 2025.
Rearranged previous paragraphs (3)
Previous report — wording carried elsewhere
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.
Previous report — wording carried elsewhere
did not show a statistically significant improvement in event free survival (EFS) for patients receiving uproleselan in combination with 7+3 chemotherapy versus chemotherapy alone.
Previous report — wording carried elsewhere
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 September 30, 2024, we had $14.4 million in cash and cash equivalents.