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]

PART I. FINANCIAL INFORMATION [Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) The company reported a **$27.9 million** net loss for H1 2022, with assets at **$65.0 million**, and faces substantial doubt about its going concern - The company's financial statements have been prepared assuming it will continue as a going concern. However, management has identified **substantial doubt** about its ability to do so for one year after the financial statements are issued, citing its current cash position of **$60.2 million**, historical net losses, and forecasted negative cash flows. The company's continuation is dependent on raising additional capital[21](index=21&type=chunk)[22](index=22&type=chunk) Condensed Balance Sheet Data (Unaudited) | (in thousands) | June 30, 2022 | December 31, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $60,244 | $90,255 | | Total current assets | $61,264 | $90,789 | | Total assets | $65,044 | $94,347 | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $8,938 | $11,824 | | Total liabilities | $9,317 | $12,743 | | Total stockholders' equity | $55,727 | $81,604 | | Total liabilities and stockholders' equity | $65,044 | $94,347 | Condensed Statements of Operations (Unaudited) | (in thousands, except per share data) | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :--- | :--- | :--- | :--- | :--- | | Revenue | $75 | $0 | $75 | $1,056 | | Research and development expense | $7,973 | $10,167 | $17,577 | $21,315 | | General and administrative expense | $5,455 | $4,237 | $10,511 | $8,425 | | Loss from operations | $(13,353) | $(14,404) | $(28,013) | $(28,684) | | **Net loss** | **$(13,268)** | **$(14,399)** | **$(27,921)** | **$(28,673)** | | Net loss per share (basic and diluted) | $(0.25) | $(0.28) | $(0.53) | $(0.56) | Condensed Statements of Cash Flows (Unaudited) | (in thousands) | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(29,929) | $(27,737) | | Net cash used in investing activities | $(82) | $(8) | | Net cash provided by financing activities | $0 | $9,564 | | **Net change in cash and cash equivalents** | **$(30,011)** | **$(18,181)** | | Cash and cash equivalents, end of period | $60,244 | $118,854 | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=19&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the clinical-stage biotech's uproleselan focus, noting R&D decrease, G&A increase, cash into Q3 2023, and substantial doubt about its going concern - The company is a clinical-stage biotechnology firm focused on developing novel glycomimetic drugs. Its lead candidate, uproleselan, is an E-selectin inhibitor being evaluated in a **Phase 3 trial** for relapsed/refractory Acute Myeloid Leukemia (AML). Top-line data from this trial is anticipated in **mid-year 2023**[86](index=86&type=chunk)[88](index=88&type=chunk) - The company's existing cash and cash equivalents of **$60.2 million** are projected to be sufficient to fund operations into the **third quarter of 2023**. This forecast does not include potential proceeds from new financing or business development activities[98](index=98&type=chunk)[99](index=99&type=chunk)[136](index=136&type=chunk) - Management confirms there is **substantial doubt** about the company's ability to continue as a going concern beyond one year from the report's issuance date without obtaining additional financing. This is due to the current cash position and forecasted negative cash flows from ongoing product development[134](index=134&type=chunk)[135](index=135&type=chunk) Comparison of Results of Operations (Six Months Ended June 30) | (in thousands) | 2022 | 2021 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Revenue | $75 | $1,056 | $(981) | (93)% | | Research and development expense | $17,577 | $21,315 | $(3,738) | (18)% | | General and administrative expense | $10,511 | $8,425 | $2,086 | 25% | | **Net loss** | **$(27,920)** | **$(28,673)** | **$753** | **(3)%** | - The **decrease in R&D expense** was primarily driven by lower clinical trial costs for the uproleselan Phase 3 trial after patient enrollment concluded in **October 2021**. This was partially offset by increased manufacturing costs for uproleselan validation batches and toxicity studies for GMI-1687[117](index=117&type=chunk)[122](index=122&type=chunk) - The **increase in G&A expense** was mainly due to commercial start-up expenses for uproleselan and higher patent fees. Personnel costs also rose with the hiring of a Chief Commercial Officer in **February 2022**[119](index=119&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 related to its **$60.2 million** in cash and cash equivalents, held in interest-bearing money market accounts - The company's main market risk exposure is from interest rate changes affecting its cash and cash equivalents of **$60.2 million**. An immediate **1% (100 basis point)** change in interest rates is **not expected to have a material effect** on the fair value of these holdings[143](index=143&type=chunk) [Controls and Procedures](index=28&type=section&id=Item%204.%20Controls%20and%20Procedures) Management evaluated the company's disclosure controls and procedures as of June 30, 2022, concluding they were effective at a reasonable assurance level - Based on an evaluation as of June 30, 2022, the Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were **effective at the reasonable assurance level**[146](index=146&type=chunk) - There were **no material changes** to the company's internal controls over financial reporting during the fiscal quarter ended June 30, 2022[147](index=147&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=29&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings and is unaware of any pending actions that could materially affect its business - As of the report date, the company is **not involved in any material legal proceedings**[148](index=148&type=chunk) [Risk Factors](index=29&type=section&id=Item%201A.%20Risk%20Factors) The company faces a new material risk of Nasdaq delisting due to non-compliance with the minimum bid price, with a deadline of November 28, 2022, to regain compliance - On **May 31, 2022**, the company received a notice from Nasdaq for **non-compliance with the minimum bid price requirement of $1.00 per share**[151](index=151&type=chunk) - The company has a **180-day period**, until **November 28, 2022**, to regain compliance by having its common stock closing bid price **at or above $1.00** for at least ten consecutive business days[151](index=151&type=chunk) - **Failure to regain compliance** could result in the **delisting** of the company's common stock from the Nasdaq Global Market, which would likely harm the stock's liquidity and price, and could make it more difficult to raise capital[152](index=152&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=29&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period covered by this report - There were **no unregistered sales of equity securities** during the quarter[153](index=153&type=chunk) [Exhibits](index=30&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the quarterly report, including certifications by the Principal Executive Officer and Principal Financial Officer and XBRL data files

Financial Data and Key Metrics Changes - As of March 31, 2022, GlycoMimetics had cash and cash equivalents of $76.5 million, down from $90.3 million as of December 31, 2021 [21] - Research and development expenses decreased to $9.6 million for Q1 2022, compared to $11.1 million for the same period in 2021, primarily due to lower clinical trial costs [23] - General and administrative expenses increased to $5.1 million for Q1 2022, up from $4.2 million in Q1 2021, mainly due to commercialization start-up expenses for uproleselan [24] Business Line Data and Key Metrics Changes - The company is focused on the Phase III registrational trial of uproleselan in relapsed/refractory AML, with 388 patients enrolled across 70 sites [7] - GMI-1687's IND-enabling program has been completed, with no safety concerns reported, and the company plans to file the IND in the first half of 2022 [15][16] Market Data and Key Metrics Changes - The U.S. market sees approximately 20,000 new AML diagnoses annually, with 12,000 deaths, indicating a significant unmet medical need in the relapsed/refractory population [31] - The company anticipates reaching the overall survival event trigger for uproleselan in mid-2023, with top-line data disclosure shortly thereafter [9] Company Strategy and Development Direction - GlycoMimetics aims to advance uproleselan towards commercialization, focusing on educating the AML community about its novel mechanism of action [12][26] - The company has streamlined its workforce by approximately 20%, primarily in early-stage research, to focus resources on commercialization efforts [18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in uproleselan's potential to transform outcomes for AML patients, emphasizing the importance of achieving deeper remissions and bridging patients to successful stem cell transplants [26] - The company is preparing for the anticipated market entry of uproleselan and is actively engaging with key opinion leaders in the clinical community [11][12] Other Important Information - The company has several investigator-sponsored trials evaluating uproleselan's potential in additional indications, with plans to publish findings at major medical meetings [14] - The partnership with the National Cancer Institute (NCI) allows access to data for regulatory purposes, enhancing the company's development strategy [13] Q&A Session Summary Question: Update on uproleselan submission timing and sales strategy - Management indicated that they are preparing for data maturity and aim to communicate top-line data quickly after the event trigger, with a focus on the relapsed/refractory patient population [29][30][31] Question: Impact of headcount reduction on operating expenses and cash runway - The company expects a slight reduction in operating expenses for 2022, with current cash on hand projected to last into Q3 2023 [36] Question: Timeline for NCI study data - The NCI study is event-based, and while specific timing for data analysis is not available, management is optimistic about the partnership and ongoing discussions with the NCI [38][39] Question: Drivers for midyear projection for uproleselan event triggering - The event trigger is driven by the number of events in the trial, with management preferring slower events as it indicates longer patient survival [44][46] Question: Development plans for early-stage pipeline assets - The company is focusing on advancing uproleselan and GMI-1687, with strategic options being considered for GMI-1359 and galectin-3 inhibitors [50][72] Question: Partnership expectations for GMI-1687 - Management is open to various partnership structures, emphasizing the importance of aligning with partners who share the vision of addressing the unmet needs in sickle cell disease [56][58]