CBIO

Our business faces significant risks and uncertainties.
The occurrence of any of these risks could harm our business, financial condition, results of operations and/or growth prospects or cause our actual results to differ materially from those contained in forward-looking statements we have made in this Annual Report on Form 10-K and those we may make from time to time.
Additional risks and uncertainties not presently known to us or that we currently believe to be immaterial may also adversely affect our business.
Risks Related to Our Financial Condition and Capital Requirements We are a clinical-stage biotechnology company with a limited operating history on which to assess our business; we have not completed any clinical trials, have no products approved for commercial sale, have historically incurred losses, and we anticipate that we will continue to incur significant losses for the foreseeable future.
Moreover, we have never generated revenue from product sales and may never be profitable.
We are a clinical-stage biotechnology company with a limited operating history.
We will need to raise substantial additional capital to continue to fund our operations in the future.
We have based our estimates on assumptions that may prove to be wrong, and could exhaust our available financial resources sooner than we currently anticipate.
We have devoted substantially all of our financial resources to identify, acquire, and develop our product candidates, organizing and staffing our company, and providing general and administrative support for our operations.
Developing our product candidates requires a substantial amount of capital.
We expect our research and development expenses to continue to increase in connection with its ongoing activities, particularly as we advance our product candidates through preclinical studies and clinical trials.
We will need to raise additional capital to fund our operations, and such funding may not be available to us on acceptable terms, or at all, and such funding may become even more difficult to obtain due to rising interest rates and the current downturn in the U.S. capital markets and the biotechnology sector in general.
Competition for additional capital among biotechnology companies may be particularly intense during economic downturns.
We may be unable to raise capital through public offerings of our ordinary shares and may need to turn to alternative financing arrangements.
Such arrangements, if we pursue them, could involve the issuance of one or more types of securities, including ordinary shares, preferred shares, convertible debt, warrants to acquire ordinary shares, or other securities.
These securities could be issued at or below the then prevailing market price for our ordinary shares.
In addition, if we issue debt securities, the holders of the debt would have a claim to our assets that would be superior to the rights of shareholders until the principal, accrued and unpaid interest, and any premium or make-whole has been paid.
Interest on any newly-issued debt securities and/or newly-incurred borrowings would increase our operating costs and reduce our net income (or increase our net loss), and these impacts may be material.
If the issuance of new securities results in diminished rights to holders of our ordinary shares, the market price of our ordinary shares could be materially and adversely affected.
We do not currently have any products approved for sale and do not generate any revenue from product sales.
Accordingly, we expect to rely primarily on equity and/or debt financings to fund our continued operations.
Our ability to raise additional funds will depend, in part, on the success of our preclinical studies and clinical trials and other product development activities, regulatory events, our ability to identify and enter into licensing or other strategic arrangements, and other events or conditions that may affect our value or prospects, as well as factors related to financial, economic, and market conditions, many of which are beyond our control.
There can be no assurances that sufficient funds will be available to us when required or on acceptable terms, if at all.
If we are unable to raise additional capital when required or on acceptable terms, we may be required to: • significantly delay, scale back, or discontinue the development or commercialization of our product candidates; • seek strategic partnerships, or amend existing partnerships, for research and development programs at an earlier stage than otherwise would be desirable or that we otherwise would have sought to develop independently, or on terms that are less favorable than might otherwise be available in the future; • dispose of technology assets, or relinquish or license on unfavorable terms, our rights to technologies or any of our product candidates that we otherwise would seek to develop or commercialize ourselves; • pursue the sale of the company to a third party at a price that may result in a loss on investment for our shareholders; or • file for bankruptcy or cease operations altogether (and face any related legal proceedings).
Any of these events could have a material adverse effect on our business, operating results, and prospects.
Even if successful in raising new capital, we could be limited in the amount of capital we raise due to investor demand restrictions placed on the amount of capital we raise or other reasons.
Additionally, any capital raising efforts are subject to significant risks and contingencies, as described in more detail under the risk factor titled “ Raising additional capital may cause dilution to our shareholders, restrict our operations, or require us to relinquish rights. ” We have never generated any revenue from product sales and may never be profitable.
We have no products approved for commercialization and have never generated any revenue from product sales.
Our ability to generate revenue and achieve profitability depends on our ability, alone or with strategic collaborators, to successfully complete the development of, and obtain the regulatory approvals necessary to commercialize, one or more of our product candidates.
We do not anticipate generating revenue from product sales for the foreseeable future.
Our ability to generate future revenue from product sales depends heavily on our success in many areas, including but not limited to: • completing research and development of our product candidates; • obtaining regulatory approvals for our product candidates for which we complete clinical trials; • manufacturing product candidates and establishing and maintaining supply and manufacturing relationships with third parties that are commercially feasible, meet regulatory requirements and our supply needs in sufficient quantities to meet market demand for our product candidates, if approved; • qualifying for adequate coverage and reimbursement by government and third-party payors for any product candidates for which we obtain regulatory approval; • marketing, launching, and commercializing product candidates for which we obtain regulatory approval, either directly or with a collaborator or distributor; • gaining market acceptance of our product candidates as treatment options; • addressing any competing products and technological and market developments; • implementing internal systems and infrastructure, as needed; • protecting and enforcing our intellectual property rights, including patents, trade secrets, and know-how; • negotiating favorable terms in any collaboration, licensing, or other arrangements into which we may enter in the future; • obtaining coverage and adequate reimbursement from third-party payors and maintaining pricing for our product candidates that supports profitability; and • attracting, hiring, and retaining qualified personnel.
Even if one or more of the product candidates that we develop is approved for commercial sale, we anticipate incurring significant costs associated with commercializing any approved product candidate.
Our expenses could increase beyond expectations if we are required by regulatory authorities to perform clinical and other studies in addition to those that we anticipate.
Even if we are able to generate revenues from the sale of any approved products, we may not become profitable and may need to obtain additional funding to continue operations.
We will also have to develop or acquire manufacturing capabilities or continue to contract with contract manufacturers in order to continue development and potential commercialization of our product candidates.
For instance, if the costs of manufacturing our drug product are not commercially feasible, we will need to develop or procure our drug product in a commercially feasible manner in order to successfully commercialize a future approved product, if any.
Additionally, if we are not able to generate revenue from the sale of any approved products, we may never become profitable.
We are a clinical-stage biotechnology company with a limited operating history on which to assess our business; we have not completed any clinical trials, have no products approved for commercial sale, have historically incurred losses, and anticipates that we will continue to incur significant losses for the foreseeable future.
Since September 19, 2024 (inception), we have incurred significant operating losses.
For the twelve months ended December 31, 2025, we reported a net loss of $153.9 million and had an accumulated deficit of $171.8.

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Risk Management Personnel Our Information Technology personnel responsible for cybersecurity risk assessment and management processes are managed by certain members of our executive management , including our Chief Financial Officer .
Together with our executive management, our Information Technology personnel are responsible for hiring appropriate personnel, helping to integrate cybersecurity risk considerations into our overall risk management strategy, and communicating key priorities to relevant personnel. Governance Our Board of Directors addresses our cybersecurity risk management as part of its general oversight function.
The Audit Committee of our Board is responsible for overseeing our cybersecurity risk management processes, including oversight and mitigation of risks from cybersecurity threats. Our Audit Committee and other members of our executive management, as appropriate, receive periodic reports from our Chief Financial Officer concerning significant cybersecurity threats and risk and the processes we have implemented to address them.
The Audit Committee also receives various periodic presentations related to cybersecurity threats, risk and mitigation. ITEM 2.
PROPERTIE S Our principal offices occupied approximately 30,000 square feet of leased office space in Rockville, Maryland, pursuant to a lease agreement that expired on January 31, 2025.
In anticipation of the consummation of the Merger, we no longer maintain a physical office or laboratory space, and all remaining employees work remotely.
LEGAL PROCEEDING S 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.
MINE SAFETY DISCLOSURE S Not applicable.
MARKET FOR REGISTRANT’S COMMON EQUIT Y, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Market Information for Common Stock Our common stock is listed on The Nasdaq Capital Market under the symbol “GLYC.” Dividend Policy We have never declared or paid any dividends on our common stock.
We do not anticipate paying cash dividends in the foreseeable future. Stockholders As of February 7, 2025, we had 64,513,862 shares of common stock outstanding held by approximately 20 holders of record.
The actual number of stockholders is greater than this number of record holders and includes stockholders who are beneficial owners but whose shares are held in street name by brokers and other nominees.
This number of holders of record also does not include stockholders whose shares may be held in trust by other entities. Recent Sales of Unregistered Securities None.
Purchases of Equity Securities by the Issuer and Affiliated Parties None.
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS You should read the following discussion and analysis of our financial condition and results of operations together with our consolidated financial statements and the related notes and other financial information included elsewhere in this Annual Report.
Some of the information contained in this discussion and analysis or set forth elsewhere in this Annual Report, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties.
“Risk Factors” and “Special Note Regarding Forward-Looking Statements” in this Annual Report for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis .
Overview and Recent Developments 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. The Merger Agreement Following the strate gic 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 second 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.
While our significant accounting policies are more fully described in Note 3 to our financial statements appearing elsewhere in this Annual Report, we believe the following are the critical accounting policies used in the preparation of our financial statements that require significant judgments and estimates. Stock-Based Compensation We have issued stock-based compensation awards to our employees and non-employee directors, including stock options.
We measure stock-based compensation expense related to these awards based on the fair value of the award, utilizing the Black-Scholes-Merton option pricing model, on the date of grant and recognize stock-based compensation expense on a straight-line basis over the requisite service period of the awards, which generally equals the vesting period.
We account for forfeitures as they occur.
We previously granted stock options with exercise prices equal to the estimated fair value of our common stock on the date of grant.

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