Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 Commission file number 001-36177 GlycoMimetics, Inc. (Exact name of Registrant as specified in its charter) Delaware 06-1686563 (State or other jurisdiction of incorporation or organization) 9708 Medical Center Drive Rockville, Maryland 20850 (Address of principal executive offices) ...

Financial Position - The company has an accumulated deficit of $447.4 million as of September 30, 2023, and expects to continue incurring significant operating losses over the next several years[101]. - The company anticipates that existing cash and cash equivalents will fund operations into late Q4 2024, without considering potential business development opportunities[102]. - As of September 30, 2023, the company had $49.4 million in cash and cash equivalents[125]. - The company reported net cash used in operating activities of $27.3 million for the nine months ended September 30, 2023, compared to $38.5 million for the same period in 2022, indicating a reduction of approximately 29%[139]. - Net cash provided by financing activities during the nine months ended September 30, 2023, was $28.8 million, primarily from sales of common stock[142]. - The company has no significant capital expenditure requirements and no other fixed long-term obligations[130]. - The company anticipates that additional capital may be required beyond currently anticipated amounts, which may not be available on reasonable terms[137]. - The company has no committed external source of liquidity, except for amounts that may be sold under the 2022 Sales Agreement and potential milestone payments from Apollomics[133]. Drug Development - The lead drug candidate, uproleselan, is being evaluated in a Phase 3 clinical trial with 388 patients enrolled, targeting acute myeloid leukemia (AML) and potentially other hematologic cancers[88]. - The FDA has cleared a protocol amendment for the pivotal Phase 3 trial, allowing for a time-based analysis of overall survival, with topline results expected by the end of Q2 2024[91]. - A Cooperative Research and Development Agreement with the National Cancer Institute is in place for a Phase 2/3 trial testing uproleselan in combination with standard chemotherapy, with 267 patients enrolled in the Phase 2 portion[92]. - The company has initiated a Phase 1a trial for GMI-1687, an E-selectin antagonist, with approximately 40 subjects expected to be enrolled, and initial results anticipated by the end of Q1 2024[96]. - The company is advancing preclinical-stage programs, including GMI-2093, targeting galectin-3 for potential treatment of fibrosis, cancer, and cardiovascular disease[98]. - The company has terminated the development of GMI-1359 and is seeking a licensing partner for further clinical development[99]. - The company is uncertain about the timing and costs necessary to complete the development of its drug candidates, including uproleselan[132]. Revenue and Expenses - The company did not generate any revenue from drug sales during the three and nine months ended September 30, 2023, and recognized $75,000 in revenue during the same period in 2022[110][120]. - Research and development expenses for the three months ended September 30, 2023, increased by $369,000 (7%) compared to the same period in 2022, totaling $5,292,000[119][121]. - Research and development expenses for the nine months ended September 30, 2023, decreased by $7.7 million (34%) compared to the same period in 2022, totaling $14,783,000[119][121]. - General and administrative expenses for the three months ended September 30, 2023, increased by $677,000 (18%) compared to the same period in 2022, totaling $4,522,000[119][123]. - General and administrative expenses for the nine months ended September 30, 2023, increased by $545,000 (4%) compared to the same period in 2022, totaling $14,901,000[119][123]. - Interest income for the three months ended September 30, 2023, increased by $367,000 (150%) compared to the same period in 2022, totaling $611,000[119][124]. - Interest income for the nine months ended September 30, 2023, increased by $1.5 million (455%) compared to the same period in 2022, totaling $1,864,000[119][124]. Legal and Compliance - The company has not been involved in any material legal proceedings that could adversely affect its business or financial condition[148]. - The company has not recognized any material changes to its critical accounting policies and estimates since December 31, 2022[109].

Financial Performance - The company reported an accumulated deficit of $438.2 million as of June 30, 2023, and anticipates continued significant operating losses over the next several years[101]. - No revenue was recognized during the three and six months ended June 30, 2023, compared to $75,000 in revenue during the same periods in 2022, representing a 100% decrease[117]. - Research and development expenses for the three months ended June 30, 2023, were $4.1 million, a decrease of $3.9 million (49%) compared to $8.0 million in 2022[116]. - General and administrative expenses decreased by $0.6 million (11%) to $4.9 million for the three months ended June 30, 2023, compared to $5.5 million in 2022[120]. - Interest income increased significantly by $0.6 million (680%) to $0.7 million for the three months ended June 30, 2023, compared to $0.1 million in 2022[121]. - Research and development expenses for the six months ended June 30, 2023, were $9.5 million, a decrease of $8.1 million (46%) compared to $17.6 million in 2022[118]. - The company has not generated any revenue from the sale of drug candidates and does not expect to do so in the near future[108]. - For the six months ended June 30, 2023, net cash used in operating activities was $(18,582) thousand, a decrease from $(29,929) thousand in the same period of 2022[136]. - The company reported net cash provided by financing activities of $28,761 thousand during the six months ended June 30, 2023, primarily from sales of common stock under its at-the-market facility with Cowen[139]. - The net change in cash and cash equivalents for the six months ended June 30, 2023, was an increase of $10,166 thousand, compared to a decrease of $(30,011) thousand in the same period of 2022[136]. - The company expects its existing cash and cash equivalents will fund operating expenses into late fourth quarter of 2024, although this estimate is based on assumptions that may prove incorrect[135]. - The company may require additional capital beyond currently anticipated amounts, which may not be available on reasonable terms[132]. Clinical Development - The lead drug candidate, uproleselan, is being evaluated in a Phase 3 clinical trial with 388 patients enrolled, focusing on acute myeloid leukemia (AML)[88]. - An interim analysis of the Phase 3 trial was conducted, with the Independent Data Monitoring Committee recommending continuation towards the final overall survival events trigger[90]. - The company expects to report topline results from the pivotal Phase 3 trial by the end of Q2 2024[91]. - A Cooperative Research and Development Agreement with the National Cancer Institute is in place for a Phase 2/3 trial testing uproleselan in combination with standard chemotherapy, with 267 patients enrolled in the Phase 2 portion[92]. - The company has initiated a Phase 1a trial for GMI-1687, an innovative E-selectin antagonist, expected to start in Q3 2023[96]. - The company is advancing preclinical-stage programs, including GMI-2093, targeting fibrosis and oncology indications[97]. - The company incurred ongoing clinical costs associated with its uproleselan clinical development programs, impacting cash used in operating activities[137]. - The company has entered into various agreements with third-party vendors for clinical trials and manufacturing, which include cancellable terms[128]. Operational Overview - The company has financed operations primarily through private placements and collaboration agreements, with no approved drugs currently available for sale[100]. - The company retains rights for uproleselan and GMI-1687 outside of Greater China, where Apollomics is responsible for development and commercialization[103]. - The company has received a total of $10 million in upfront and milestone payments from Apollomics, with potential further milestone payments totaling approximately $179 million[103]. - The company anticipates an increase in general and administrative expenses in the future as it undertakes commercialization efforts for uproleselan[115]. - The company expects research and development expenses to increase over the next several years as it progresses its drug candidates through clinical development[112]. - As of June 30, 2023, the company had $58.0 million in cash and cash equivalents[122]. - As of June 30, 2023, the company has total remaining lease obligations of $1.4 million under a non-cancelable lease for its office space in Rockville, Maryland, which extends through January 2025[127]. - The company has no fixed long-term obligations and does not anticipate significant capital expenditure requirements[127].

Financial Data and Key Metrics Changes - The company's research and development expenses decreased to $5.4 million for the quarter ended March 31, 2023, compared to $9.6 million for the same period in 2022, primarily due to lower clinical trial costs [9] - General and administrative expenses increased to $5.5 million for the quarter ended March 31, 2023, compared to $5.1 million for the same period in 2022, mainly due to commercial readiness planning expenses for uproleselan [9] - As of March 31, 2023, cash and cash equivalents were $65 million, up from $47.9 million as of December 31, 2022, following a $28.7 million raise from sales of common stock [27] Business Line Data and Key Metrics Changes - The pivotal Phase III trial of uproleselan in patients with relapsed and refractory AML is projected to reach its final survival event trigger within the first half of 2024, with a median follow-up of over 27 months [4][25] - The NCI Alliance Phase II/III trial is evaluating uproleselan in newly diagnosed older adults with AML, with an expected improvement in median event-free survival from seven to eleven months [7][25] Market Data and Key Metrics Changes - The incidence of AML increases with age, with over half of AML patients being older than 60 at diagnosis, highlighting the need for new therapies for this demographic [7] Company Strategy and Development Direction - The company is focused on advancing uproleselan's clinical development and preparing for its potential commercialization, aiming to transition into a commercial stage company [4][27] - The partnership with the National Cancer Institute and the Alliance for Clinical Trials in Oncology is part of the strategy to explore uproleselan's benefits across the AML spectrum [5][29] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about uproleselan's potential to improve overall survival in relapsed refractory AML and emphasized the ethical obligation to evaluate its benefits as soon as possible [23][29] - The independent data monitoring committee's interim analysis showed no safety concerns, preserving statistical power for the final analysis [25] Other Important Information - The company is well-funded to complete ongoing trials and continue its transformation into a commercial stage company capable of delivering impactful medicines [29] Q&A Session Summary Question: What is the current projection for the primary endpoint for the R&R AML Phase III data? - Management confirmed that the final overall survival event trigger is expected in the first half of 2024, with ongoing projections being communicated [12][46] Question: Are there any updates on the pipeline development outside of uproleselan? - Management indicated that while there are ongoing discussions regarding GMI 1687, the primary focus remains on uproleselan at this time [44][51] Question: How should expenses be anticipated as the company prepares for the uproleselan launch? - Management anticipates a burn rate of about $10 million per quarter for 2023 and into 2024, with further guidance to be provided after trial results [52]

Financial Performance - The company has an accumulated deficit of $429.9 million as of March 31, 2023, and expects to continue incurring significant operating losses over the next several years[102]. - The net loss for Q1 2023 was $10.359 million, a reduction of 29% from a net loss of $14.653 million in Q1 2022[124]. - Total costs and expenses for Q1 2023 were $10.941 million, down 25% from $14.660 million in Q1 2022[124]. - Research and development expenses for Q1 2023 were $5.419 million, a decrease of 44% from $9.604 million in Q1 2022[124]. - General and administrative expenses increased by 9% to $5.522 million in Q1 2023, compared to $5.056 million in Q1 2022[126]. - Interest income surged to $582,000 in Q1 2023, an increase of 8,214% from $7,000 in Q1 2022[124]. - Cash and cash equivalents as of March 31, 2023, totaled $65.0 million, providing liquidity for operations[128]. - The company sold 9,822,930 shares under the 2022 Sales Agreement at a weighted average price of $3.01 per share, generating net proceeds of $28.7 million in Q1 2023[130]. - Net cash provided by financing activities for Q1 2023 was $28.7 million from common stock sales[145]. - No financing activities were reported for Q1 2022[145]. Drug Development - The lead drug candidate, uproleselan, is being evaluated in a Phase 3 clinical trial with 388 patients enrolled, showing pooled survival data indicating patients are living longer than historically expected[92]. - The interim analysis of the Phase 3 trial was recommended to continue by the Independent Data Monitoring Committee, with projections to reach the overall survival events trigger in the first half of 2024[95]. - The company is advancing GMI-1687, an innovative E-selectin antagonist, with an IND application filed for treatment of vaso-occlusive crisis in sickle cell disease[98]. - The company has selected GMI-2093 as a lead galectin drug candidate for preclinical studies targeting fibrosis, cancer, and cardiovascular disease[99]. - The company is not currently developing GMI-1359 but is seeking a licensing partner for its clinical development[100]. - Research and development costs related to the drug candidate uproleselan decreased by 57% to $2.272 million in Q1 2023 from $5.286 million in Q1 2022[125]. Business Operations - The company has no approved drugs currently available for sale, with revenue primarily from upfront and milestone payments under license and collaboration agreements[101]. - The company has entered into a collaboration agreement with Apollomics, receiving an upfront payment of $9.0 million and potential milestone payments totaling approximately $179.0 million[109]. - The company anticipates that existing cash and cash equivalents will fund operations into late fourth quarter of 2024, without considering potential business development opportunities[104]. - The company expects existing cash resources to fund operations into late Q4 2024, based on current assumptions[141]. - The company has experienced minor disruptions from the COVID-19 pandemic, including a brief delay in patient enrollment for the Phase 3 trial of uproleselan[105]. - The company anticipates an increase in general and administrative expenses as commercialization efforts for uproleselan ramp up[122]. - The company is classified as a smaller reporting company and is not required to provide additional market risk disclosures[146].

Financial Data and Key Metrics Changes - As of December 31, 2022, GlycoMimetics had cash and cash equivalents of $47.9 million, down from $90.3 million as of December 31, 2021 [11] - Expenses for the second half of 2022 decreased to $19.2 million compared to $30.4 million in the first half of 2022 [11] - Research and development expenses decreased to $5.9 million for Q4 2022 from $12.9 million in Q4 2021, primarily due to lower global Phase III clinical study costs [11] - General and administrative expenses increased to $4.7 million for Q4 2022 from $4.5 million in Q4 2021, mainly due to higher pre-commercial expenses for uproleselan [11] Business Line Data and Key Metrics Changes - The pivotal Phase III study of uproleselan in relapsed/refractory AML continues to show promising results, with a median follow-up of over 25 months [7] - The transplant rate in the study is above the 31% rate observed in the preceding Phase I/II trial, with a low patient dropout rate of about 3% [9] Market Data and Key Metrics Changes - The company completed a financing round in February 2023, raising $32.9 million, which is expected to extend the cash runway to the end of 2024 [12][23] - The study is on track to have the longest follow-up of any study in relapsed/refractory AML at the point of primary analysis, potentially exceeding three years [23][25] Company Strategy and Development Direction - The company is focused on strengthening its leadership team, sustaining clinical progress for uproleselan, and raising capital for continued trials [6] - GlycoMimetics aims to evolve into a commercial stage company capable of delivering important new medicines to patients [12] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the interim analysis of the Phase III study, which found no safety concerns and recommended continuing to the final analysis [12] - The company remains focused on delivering new options to patients waiting for better standard care therapies for AML [25] Other Important Information - The interim analysis employed a high statistical threshold to preserve the integrity of the final analysis, with no safety concerns noted [24] - The company is engaging with the medical community to raise awareness of uproleselan's unique mechanism of action [32] Q&A Session Summary Question: When do you expect data for the NCI sponsored trial to come out? - Management indicated that there has been no official update from NCI, and it is reasonable to assume that data may be delayed similar to the Phase III study [14] Question: What is the status of GMI-1687? - The company is currently focused on uproleselan and is open to partnerships for GMI-1687 but is not actively pursuing a Phase I trial at this time [29] Question: How does the statistical team predict the event timing? - The statistical team has developed a robust projection tool considering various patient characteristics, and updated projections indicate the full event trigger is expected in H1 2024 [31]

Drug Development and Clinical Trials - The company is developing uproleselan, a specific E-selectin antagonist, for treating acute myeloid leukemia (AML) and has received Breakthrough Therapy designation from the FDA[19]. - In a Phase 1/2 trial, uproleselan demonstrated a 69% rate of minimal residual disease negativity in evaluable participants with relapsed/refractory AML[23]. - The company completed enrollment of 388 patients in a Phase 3 pivotal clinical trial for uproleselan in relapsed/refractory AML, with an interim analysis planned based on 80% of survival events[24][26]. - GMI-1687, an innovative antagonist of E-selectin, has shown equivalent activity to uproleselan at an approximately 1,000-fold lower dose in animal models[28]. - The company anticipates reaching the overall survival events trigger for the Phase 3 trial in the first half of 2024, with top line data disclosure expected soon thereafter[26]. - Uproleselan is in a Phase 3 clinical trial for relapsed/refractory acute myeloid leukemia (AML) with 388 patients enrolled across multiple countries, expecting overall survival event trigger in the first half of 2024[34]. - Uproleselan demonstrated improved chemotherapy sensitivity in preclinical studies, reducing tumor burden in AML models[54][57]. - Uproleselan demonstrated a complete remission (CR) rate of 41% and a median overall survival (OS) of 8.8 months in the relapsed/refractory acute myeloid leukemia (R/R AML) cohort[66]. - In the newly diagnosed AML cohort, the CR rate was 72% with a median OS of 12.6 months, significantly better than historical controls which reported event-free survival (EFS) of 2.0-6.5 months[66]. - The ongoing Phase 3 trial for uproleselan has enrolled 388 patients, with an interim analysis planned to assess overall survival events in the first half of 2024[69]. - The Phase 1 trial of uproleselan in healthy volunteers indicated good tolerability and pharmacokinetics consistent with preclinical data[61]. - The company is collaborating with the NCI on a Phase 2/3 trial for uproleselan in older adults with untreated AML, aiming to enroll approximately 670 patients[70]. - GMI-1687 received FDA clearance for investigational new drug application in June 2022, targeting vaso-occlusive crisis in sickle cell disease[29]. - The China National Medical Products Administration granted IND approval for uproleselan, enabling the initiation of a Phase 1 PK and tolerability study, and a Phase 3 bridging study in combination with chemotherapy for relapsed/refractory AML[81]. Financial Performance and Projections - The company has incurred significant losses since inception and expects to continue incurring losses over the next several years[12]. - As of December 31, 2022, the company had an accumulated deficit of $419.6 million[180]. - The company expects to continue incurring significant expenses and operating losses over the next several years[181]. - The company anticipates that expenses will increase substantially and negative cash flows from operating activities will continue over the next 12 months[181]. - The company has financed operations through public offerings and collaboration agreements, focusing on research and development[180]. - The company expects significant fluctuations in financial condition and operating results due to various uncontrollable factors[196]. - The company anticipates that raising additional capital may cause dilution to stockholders and restrict operations[190]. - The company’s ability to generate revenue from uproleselan is contingent on Apollomics achieving development, regulatory, and commercial milestones, which are largely out of the company's control[183]. Regulatory Environment - The company is subject to extensive government regulation, requiring substantial time and financial resources for obtaining regulatory approvals and compliance[102][103]. - The FDA requires completion of preclinical studies, including laboratory tests and animal studies, before an IND can be submitted[105]. - An IND becomes effective 30 days after submission unless the FDA raises concerns, which can delay clinical trials[104]. - Approval of an NDA requires satisfactory completion of FDA inspections of manufacturing facilities and clinical trial sites[117]. - The FDA may grant expedited review programs, such as fast track designation and priority review, to drugs addressing serious conditions[120][122]. - Post-approval, drugs are subject to ongoing FDA regulation, including requirements for recordkeeping and reporting adverse experiences[127]. - The FDA may withdraw approval if compliance with regulatory requirements is not maintained after market entry[130]. - Manufacturers must continue to comply with cGMP requirements and may face inspections to ensure adherence[129]. - The FDA restricts marketing of drugs to approved indications, and violations can lead to significant liability[133]. Market and Competitive Landscape - The competitive landscape includes several therapies approved for AML treatment, with significant competition from companies with greater financial resources and expertise[99][101]. - The future commercial success of drug candidates depends on adequate reimbursement levels from governmental and private payors[146]. - Third-party payors are increasingly imposing restrictions on coverage and reimbursement levels, influencing healthcare product purchases[147]. - Legislative proposals to reform healthcare may result in lower reimbursement rates or exclusion of drugs from coverage[148]. - The PPACA established an annual fee on entities manufacturing specified branded prescription drugs, impacting profitability[151]. - The Inflation Reduction Act of 2022 will eliminate the Medicare Part D "donut hole" starting in 2025, affecting drug pricing strategies[152]. - There is increasing legislative interest in drug pricing practices, with potential reforms aimed at enhancing transparency and controlling costs[153]. - State legislatures are implementing regulations to control pharmaceutical pricing, including price constraints and marketing cost disclosures[154]. Intellectual Property and Licensing - The company has issued patents covering uproleselan and GMI-1687, with expiration dates expected between 2032 and 2042, and is actively seeking to expand its intellectual property estate[84][87]. - The company plans to seek licensing partners for GMI-1359 and expand the use of E-selectin antagonists in select territories[34][41]. - The company entered into an exclusive collaboration and license agreement with Apollomics for the development and commercialization of uproleselan and GMI-1687 in Greater China, receiving an upfront cash payment of $9.0 million and potential milestone payments totaling approximately $180.0 million[79]. - Apollomics is responsible for all clinical development and commercialization activities in Greater China, while the company retains all rights for both compounds in the rest of the world[79]. - The company has established a joint development committee with Apollomics to oversee activities under the collaboration and license agreement[82]. Operational Challenges - The company relies on third parties for clinical trials and manufacturing, which increases risks related to timely and sufficient production of drug candidates[12]. - The company does not have manufacturing facilities and relies on third parties for the manufacturing of its drug candidates, expecting a significant increase in manufacturing if marketing approval is received for uproleselan[91]. - The company faces potential disruptions in its supply chain due to government orders and restrictions, which could impact third-party manufacturing facilities in the United States and other countries[208]. - Manufacturing supply interruptions of uproleselan, currently produced in Switzerland and China, may adversely affect ongoing and future clinical trials[208]. Employee and Organizational Structure - The company has 39 employees, with no representation by labor unions[172]. - The company aims to attract and retain high-performing employees through equity-based compensation awards[173].

GlycoMimetics, Inc. (NASDAQ:GLYC) Q3 2022 Earnings Conference Call November 9, 2022 8:30 AM ET Company Participants Christian Dinneen-Long - Company Counsel Harout Semerjian - President and Chief Executive Officer Brian Hahn - Senior Vice President and Chief Financial Officer Bruce Johnson - Senior Vice President and Chief Commercial Officer Edwin Rock - Chief Medical Officer Conference Call Participants Edward White - H.C. Wainwright Operator Good morning and thank you for joining the GlycoMimetics Q3 2022 ...

PART I. FINANCIAL INFORMATION [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) Unaudited Q3 2022 financial statements reveal decreased assets and equity, a lower net loss, and significant going concern doubts [Balance Sheets](index=4&type=section&id=Balance%20Sheets) Balance sheets show a significant decrease in total assets and stockholders' equity from December 2021 to September 2022, primarily due to reduced cash Balance Sheet Summary (Unaudited) | | September 30, 2022 ($) | December 31, 2021 ($) | | :--- | :--- | :--- | | **Total Assets** | $55,961,447 | $94,346,648 | | **Total Liabilities** | $7,843,864 | $12,742,997 | | **Total Stockholders' Equity** | $48,117,583 | $81,603,651 | [Statements of Operations and Comprehensive Loss](index=5&type=section&id=Unaudited%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company reported a reduced net loss for both the third quarter and the first nine months of 2022, primarily driven by lower research and development expenses Operating Results (Unaudited) | | Three Months Ended Sep 30, 2022 ($) | Three Months Ended Sep 30, 2021 ($) | Nine Months Ended Sep 30, 2022 ($) | Nine Months Ended Sep 30, 2021 ($) | | :--- | :--- | :--- | :--- | :--- | | **Revenue** | $0 | $86,560 | $75,000 | $1,142,142 | | **Total Costs and Expenses** | $8,767,436 | $17,423,506 | $36,855,702 | $47,163,475 | | **Net Loss** | $(8,523,839) | $(17,332,321) | $(36,444,447) | $(46,005,641) | | **Net Loss Per Share** | $(0.16) | $(0.34) | $(0.70) | $(0.90) | [Statements of Stockholders' Equity](index=6&type=section&id=Unaudited%20Statements%20of%20Stockholders'%20Equity) Total stockholders' equity significantly decreased from December 2021 to September 2022, primarily due to the cumulative net loss for the nine-month period - The accumulated deficit grew from **$(372.9) million** at the end of 2021 to **$(409.3) million** by September 30, 2022, reflecting ongoing net losses[14](index=14&type=chunk) [Statements of Cash Flows](index=7&type=section&id=Unaudited%20Statements%20of%20Cash%20Flows) Net cash used in operating activities remained substantial for the nine months ended September 30, 2022, leading to a significant decline in cash and cash equivalents Cash Flow Summary (Unaudited) | | Nine Months Ended Sep 30, 2022 ($) | Nine Months Ended Sep 30, 2021 ($) | | :--- | :--- | :--- | | **Net cash used in operating activities** | $(38,545,919) | $(44,682,965) | | **Net cash used in investing activities** | $(84,190) | $(12,496) | | **Net cash provided by financing activities** | $0 | $9,584,728 | | **Net change in cash and cash equivalents** | $(38,630,109) | $(35,110,733) | | **Cash and cash equivalents, end of period** | $51,624,781 | $101,924,284 | [Notes to Unaudited Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Financial%20Statements) The notes highlight substantial doubt about the company's going concern ability, emphasizing the need for additional capital and detailing key accounting policies and expenses - Management has concluded there is **substantial doubt** about the company's ability to continue as a **going concern** for one year from the financial statement issuance date without obtaining additional financing[21](index=21&type=chunk) - The company's ability to fund operations depends on **raising capital** through equity/debt financings, collaborations, or other strategic arrangements[22](index=22&type=chunk) - Under the Apollomics agreement, the company **did not recognize any milestone revenue** in the first nine months of 2022, while in 2021 it recognized **$1.1 million** from clinical supplies sales[81](index=81&type=chunk)[83](index=83&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=19&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses clinical drug development, reduced R&D expenses from trial completion, increased G&A, and the critical need for additional funding to sustain operations - The company's lead drug candidate, **uproleselan**, has completed enrollment in its **Phase 3 trial** for relapsed/refractory AML, with an **interim analysis** expected by the **end of 2022**[91](index=91&type=chunk)[93](index=93&type=chunk) Research and Development Expense by Drug Candidate (Nine Months Ended Sep 30) | (dollars in thousands) | 2022 ($) | 2021 ($) | Net Change ($) | % Change | | :--- | :--- | :--- | :--- | :--- | | Uproleselan | $11,526 | $21,064 | $(9,538) | (45)% | | GMI-1687 | $1,201 | $1,451 | $(250) | (17)% | | GMI-1359 | $120 | $509 | $(389) | (76)% | | **Total R&D Expense** | **$22,500** | **$34,596** | **$(12,096)** | **(35)%** | - The company's cash and cash equivalents of **$51.6 million** as of September 30, 2022, are expected to fund operations to the **end of 2023**[138](index=138&type=chunk) - Management has concluded there is **substantial doubt** about the company's ability to continue as a **going concern** beyond one year from the report's issuance **without additional financing**[137](index=137&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=28&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company's primary market risk is interest rate sensitivity on its cash and cash equivalents, though a 100 basis point change is not expected to materially impact fair value - The company's primary market risk is **interest rate sensitivity** on its **$51.6 million** in cash and cash equivalents[146](index=146&type=chunk) - Due to the short-term and low-risk nature of its investments, a **100 basis point change** in interest rates is **not expected to have a material effect** on the fair market value of its cash equivalents[146](index=146&type=chunk) [Controls and Procedures](index=28&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of September 30, 2022, with no material changes to internal controls over financial reporting during the quarter - Management concluded that disclosure controls and procedures were **effective** as of September 30, 2022[150](index=150&type=chunk) - There were **no material changes** in internal controls over financial reporting during the fiscal quarter ended September 30, 2022[151](index=151&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=29&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings and is unaware of any pending litigation that would materially impact its operations - The company is **not currently a party** to any **material legal proceedings**[152](index=152&type=chunk) [Risk Factors](index=30&type=section&id=Item%201A.%20Risk%20Factors) The primary risk factor is the potential delisting from Nasdaq due to non-compliance with the minimum bid price requirement, which could severely harm stock liquidity - On May 31, 2022, the company received a notice from **Nasdaq** for failing to meet the **$1.00 minimum bid price requirement**[156](index=156&type=chunk) - The company has a **180-day period**, until **November 28, 2022**, to regain compliance[156](index=156&type=chunk) - A **potential delisting** from Nasdaq could make it **difficult to trade** the company's common stock and could **hinder future capital-raising efforts**[157](index=157&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=30&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities or use of proceeds during the reporting period - None[158](index=158&type=chunk) [Exhibits](index=31&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the quarterly report, including corporate governance documents and Sarbanes-Oxley Act certifications - The exhibits include **certifications** from the Principal Executive Officer and Principal Financial Officer under **Sections 302 and 906 of the Sarbanes-Oxley Act**[160](index=160&type=chunk) [Signatures](index=32&type=section&id=Signatures) The report was officially signed on November 9, 2022, by Brian M. Hahn, the company's Senior Vice President and Chief Financial Officer - The report was signed on **November 9, 2022**, by **Brian M. Hahn**, **Senior Vice President and Chief Financial Officer**[165](index=165&type=chunk)

Financial Data and Key Metrics Changes - As of June 30, 2022, GlycoMimetics had cash equivalents of $60.2 million, down from $90.3 million as of December 31, 2021, with expectations that current cash resources will fund operations into the third quarter of 2023 [34] - Research and development expenses decreased to $8 million for the quarter ended June 30, 2022, compared to $10.2 million for the same period in 2021, primarily due to lower clinical trial costs related to the ongoing Phase III trial of uproleselan [35] - General and administrative expenses increased to $5.5 million for the quarter ended June 30, 2022, compared to $4.2 million for the second quarter of 2021, mainly due to commercialization startup expenses for uproleselan [36] Business Line Data and Key Metrics Changes - The Phase III trial of uproleselan is currently evaluating salvage chemotherapy with or without the drug, with a primary endpoint of overall survival [10] - The Phase III population is broadly similar to the Phase I/II study regarding age, severity of AML, and prior stem cell transplantation rates, with a median age of 58 years [11] - The Phase II portion of the NCI trial has completed enrollment of 267 patients, with an interim analysis planned [13] Market Data and Key Metrics Changes - AML is one of the most common types of leukemia in adults, with a global median incidence rate of almost 2.3 cases per 100,000, and over 20,000 adults diagnosed annually in the U.S. [23] - Long-term patient outcomes in AML are poor, with approximately 70% of newly diagnosed patients relapsing within three years and a five-year overall survival rate of 29% [24] - Current standard-of-care therapies for AML are limited in achieving deep, durable remissions, with only 20% to 30% of relapsed refractory patients achieving complete remission [26] Company Strategy and Development Direction - The company is focused on advancing the development of uproleselan and preparing for its potential commercialization, with a strong emphasis on regulatory and commercial readiness [8] - GlycoMimetics aims to establish uproleselan as a first-in-class E-selectin antagonist to disrupt the standard of care in both relapsed refractory and newly diagnosed AML [21] - The company is also exploring partnerships for GMI-1687, a sickle cell disease program, while prioritizing resources on uproleselan development [17][56] Management's Comments on Operating Environment and Future Outlook - Management remains confident in the potential of uproleselan to transform outcomes in AML patients, with a projected event trigger for overall survival expected in mid-2023 [12] - The company is committed to closely monitoring the Phase III trial and will provide updates as necessary [41] - Management emphasizes the importance of physician awareness and enthusiasm for uproleselan, indicating a significant market opportunity [30] Other Important Information - The company has received FDA fast-track and breakthrough therapy designation for uproleselan in relapsed refractory AML, facilitating rapid regulatory submissions [12] - The company is preparing for potential market entry of uproleselan and is focused on ensuring resources are allocated effectively for commercialization [19] Q&A Session Summary Question: How are the OS events tracking versus projections for the uproleselan Phase III trial? - Management confirmed that the overall survival events are still tracking in line with previous projections, expected to mature in mid-2023 [41] Question: When will initial results from the combination studies with venetoclax be available? - Management indicated that initial data might be available as early as the upcoming ASH conference, but the timeline depends on the principal investigators [43] Question: Are there differences in patient baseline characteristics between the Phase III and Phase II trials? - Management acknowledged that while the characteristics are broadly similar, there are slight differences in terms of prior remission duration and risk categories [46] Question: How often will updates be received from the NCI study? - Management stated that updates will be provided once the NCI completes their analysis, with the expectation that results will be communicated in a timely manner [50] Question: What is the status of business development activities and cash runway? - Management emphasized that business development remains a focus, particularly for GMI-1687, and that cash resources are being preserved to prioritize uproleselan [56][58]