Group 1 - Crescent Biopharma, Inc. is focused on developing CR-001, a tetravalent VEGF1 x PD-1 bispecific antibody aimed at treating solid tumors [1] - The company will present at the Jefferies London Healthcare Conference on November 19, 2024 [1][2] - Crescent has entered into an acquisition agreement with GlycoMimetics, Inc., and the combined entity will continue under the name Crescent [2] Group 2 - Crescent Biopharma's pipeline includes three programs that leverage validated biology to expedite the development of potentially best-in-class therapeutics for solid tumors [3]

Core Viewpoint - Monteverde & Associates PC is investigating GlycoMimetics, Inc. regarding a proposed merger with First Crescent Biopharma, Inc., which will significantly dilute GlycoMimetics shareholders' ownership in the combined company [1]. Company Overview - Monteverde & Associates PC is recognized as a Top 50 Firm in the 2018-2022 ISS Securities Class Action Services Report and has a successful track record in recovering money for shareholders [1][2]. - The firm is headquartered in the Empire State Building, New York City, and specializes in class action securities litigation [2]. Merger Details - Under the proposed merger agreement, pre-acquisition GlycoMimetics stockholders are expected to own approximately 3.1% of the combined company, while pre-acquisition Crescent stockholders will own approximately 96.9% [1].

Group 1 - Monteverde & Associates PC is investigating GlycoMimetics, Inc. regarding a proposed merger with First Crescent Biopharma, Inc. [1] - Under the merger agreement, pre-acquisition GlycoMimetics stockholders are expected to own approximately 3.1% of the combined company, while pre-acquisition Crescent stockholders are expected to own approximately 96.9% [1] Group 2 - Monteverde & Associates PC is recognized as a Top 50 Firm in the 2018-2022 ISS Securities Class Action Services Report and has a successful track record in recovering money for shareholders [1][2] - The firm operates from the Empire State Building in New York City and specializes in class action securities litigation [2]

Drug Development and Clinical Trials - The lead glycomimetic drug candidate, uproleselan, showed a median overall survival of 13.0 months in the treatment arm compared to 12.3 months in the placebo arm, but the difference was not statistically significant [64]. - In the subgroup of primary refractory patients, the median overall survival for those treated with uproleselan was 31.2 months compared to 10.1 months for the placebo group, indicating a significant benefit [66]. - A Cooperative Research and Development Agreement with the National Cancer Institute is ongoing for a Phase 2/3 trial of uproleselan, with enrollment of 267 patients completed in December 2021 [67]. - GMI-1687, an innovative antagonist of E-selectin, is being developed for vaso-occlusive events in sickle cell disease, with a Phase 1a trial completed in December 2023 [68]. - The Phase 3 trial of uproleselan did not achieve a statistically significant improvement in overall survival in the intent to treat population [64]. - The Phase 3 bridging study for uproleselan completed enrollment with 140 adult patients across 20 sites in Greater China, focusing on overall survival as the primary endpoint [73]. - The company has suspended a project agreement for the manufacture and supply of injectable uproleselan and has no binding obligation to acquire the product [94]. - The company has initiated the closure of all clinical sites and will incur close-out costs [94]. Financial Performance and Expenses - The company reported an accumulated deficit of $478.3 million as of June 30, 2024, and continues to incur operating losses [69]. - The company reported a net loss of $10.1 million for the three months ended June 30, 2024, compared to a net loss of $8.3 million in the same period in 2023, representing an increase of $1.8 million (22%) [85]. - Total costs and expenses for the three months ended June 30, 2024, were $10.4 million, an increase of $1.4 million (16%) from $8.9 million in the same period in 2023 [85]. - Research and development expenses for the three months ended June 30, 2024, increased by $2.2 million (54%) to $6.3 million compared to $4.1 million in the same period in 2023 [85]. - For the six months ended June 30, 2024, research and development expenses rose by $2.8 million (30%) to $12.3 million from $9.5 million in the same period in 2023 [86]. - General and administrative expenses decreased by $0.8 million (16%) for the three months ended June 30, 2024, and by $1.2 million (12%) for the six months ended June 30, 2024, compared to the same periods in 2023 [88]. - Interest income for the three months ended June 30, 2024, decreased by $409,000 (61%) to $262,000 compared to $671,000 in the same period in 2023 [85]. - Interest income decreased by $0.4 million (for three months) and $0.6 million (for six months) due to lower invested cash and cash equivalent balances compared to the same periods in 2023 [89]. - The company incurred a net loss of $36.9 million during 2023 [99]. Strategic Initiatives and Future Outlook - Following the Phase 3 trial results, the company initiated a strategic review process, which may include a merger, sale, or other strategic transactions [70]. - A workforce reduction plan was implemented, reducing the workforce by approximately 80% to maximize capital preservation [70]. - The company expects its current cash and cash equivalents to fund operations into the second quarter of 2025, but may need to raise additional capital or further reduce expenses [71]. - The company has no committed source of additional funding from debt or equity financings as of June 30, 2024 [99]. - The company sold 9,822,930 shares of common stock under the 2022 Sales Agreement in 2023, generating net proceeds of $28.7 million [91]. - Net cash used in operating activities for the six months ended June 30, 2024, was $19.4 million, compared to $18.6 million for the same period in 2023 [100]. - Net cash provided by financing activities during the six months ended June 30, 2024, consisted of proceeds from stock option exercises, while in 2023, it was primarily from sales of common stock [103]. Collaboration and Revenue - The company has entered into a collaboration with Apollomics for the development of uproleselan and GMI-1687 in Greater China [72]. - The company recognized $1.1 million in revenue from clinical supplies sold to Apollomics during the year ended December 31, 2021, but reported no sales during the six months ended June 30, 2024, or 2023 [74]. - The company has not generated any revenue from drug sales to date and does not expect to do so in the near future, relying primarily on upfront and milestone payments from collaboration agreements [77]. - The company received an upfront cash payment of $9.0 million and a $1.0 million milestone payment in September 2020, with potential further milestone payments totaling approximately $179.0 million and tiered royalties ranging from high single digits to 15% of net sales [73].

Financial Performance - The company reported an accumulated deficit of $467.2 million as of March 31, 2024, and expects to continue incurring operating losses over the next several years [96]. - The company has no revenue from drug sales and does not expect to generate revenue in the near future, relying on milestone payments from collaboration agreements [105]. - Net loss for Q1 2024 was $10,737,000, a decrease of $378,000 (4%) compared to a net loss of $10,359,000 in Q1 2023 [114]. - Interest income decreased by $204,000 (35%) to $378,000 in Q1 2024 due to lower cash and cash equivalent balances [118]. - As of March 31, 2024, the company had $31.3 million in cash and cash equivalents, with no committed source of additional funding [130]. - The company expects existing cash and cash equivalents to fund operating expenses through Q4 2024, but plans to reduce expenses to preserve capital [131]. - Net cash used in operating activities for Q1 2024 was $10,509,000, an improvement from $11,607,000 in Q1 2023 [132]. - The company sold 9,822,930 shares under the 2022 Sales Agreement in 2023, raising $28.7 million in net proceeds [120]. Drug Development - The lead drug candidate, uproleselan, showed a median overall survival of 13 months in patients treated with it, compared to 12.3 months in the placebo group during a Phase 3 trial [87]. - The company completed enrollment of 388 patients in a Phase 3 pivotal clinical trial for uproleselan in 2021, based on FDA guidance [86]. - A Cooperative Research and Development Agreement with the National Cancer Institute is in place for a Phase 2/3 trial testing uproleselan with standard chemotherapy, with 267 patients enrolled in the Phase 2 portion [88]. - The Phase 3 bridging study for uproleselan in Greater China has enrolled 140 patients, with overall survival as the primary endpoint [101]. - GMI-1687, an innovative E-selectin antagonist, completed enrollment of 40 subjects in a Phase 1a trial in December 2023 [92]. - The company is uncertain about the timing and costs associated with the development of its drug candidates, including uproleselan [125]. Capital Management - The company has raised capital primarily through private placements and collaboration agreements, with no approved drugs currently available for sale [95]. - The company plans to reduce operating expenses in the upcoming months to preserve capital, although this may not significantly extend the cash runway [97]. - A purchase commitment of $3,768,000 was entered into for raw materials to support the next commercial manufacturing campaign [123]. - The company received an upfront cash payment of $9.0 million from Apollomics for the development and commercialization of uproleselan and GMI-1687 in Greater China [100]. Expenses - Research and development expenses for Q1 2024 increased by $606,000 (11%) to $6,025,000 compared to Q1 2023 [114]. - General and administrative expenses decreased by $432,000 (8%) to $5,090,000 in Q1 2024, primarily due to lower personnel-related expenses [117].

Clinical Trials and Research - Uproleselan (GMI-1271) is currently in a Phase 3 trial for relapsed/refractory acute myeloid leukemia (R/R AML) with 388 patients enrolled, and topline results are expected to be announced in Q2 2024[4] - The Phase 2 trial for newly diagnosed "fit" AML has fully enrolled 267 patients, sponsored by the National Cancer Institute (NCI)[4] - In the Phase 1/2 trials, Uproleselan demonstrated a complete response (CR) rate of 35% in R/R AML patients and 52% in newly diagnosed patients aged 60 and above[17] - The median overall survival for Uproleselan in the Phase 3 trial was reported at 13 months compared to 12.3 months for the placebo arm[34] - The combination of Uproleselan with 7&3 chemotherapy is being evaluated in a Phase 2/3 trial for patients aged 60 and above, with a total enrollment of 267 patients completed[52] - Uproleselan demonstrated a median overall survival (mOS) of 13 months compared to 12.3 months in the control group, with a follow-up duration of 37 months as of March 2024[48] - The VALOR trial showed a mOS of 7.5 months versus 6.1 months, with a total enrollment of 711 patients[48] - In the ADMIRAL trial, mOS was reported at 9.3 months compared to 5.6 months, with 371 patients enrolled[48] - GlycoMimetics reported a 39% overall response rate (ORR) in a very high-risk patient population treated with Uproleselan combined with Cladribine and Low Dose Ara-C[61] Product Development and Designations - GlycoMimetics has received Breakthrough Therapy designation for Uproleselan in AML, highlighting its potential in addressing significant unmet medical needs[10] - The company is developing GMI-1687 for sickle cell disease (SCD) with a Phase 1a trial completed, targeting vaso-occlusive crises[5] - The company is developing a novel oral Galectin-3 antagonist targeting sickle cell disease (SCD) vaso-occlusive crisis, aimed for self-administration during crises[83] - GlycoMimetics has received Breakthrough Therapy, Fast Track, and Orphan designations for its first-in-class compounds, indicating potential broad utility[77] Market and Patient Demographics - Approximately 20,380 new AML cases are estimated in the U.S. annually, with around 12,000 patients eligible for intensive chemotherapy[24] - Approximately 20,380 newly diagnosed AML patients are expected annually in the U.S., with around 12,000 being eligible for intensive chemotherapy[50] Strategic Partnerships and Market Expansion - GlycoMimetics is partnered with Apollomics for the development of its products in Greater China, expanding its market reach[9] - The company is focusing on expanding its market presence through innovative therapies and clinical trials[49] Commitment to Research and Development - GlycoMimetics plans to submit comprehensive analysis results for presentation at an upcoming medical conference, reflecting ongoing commitment to research and development[34] - GlycoMimetics is committed to developing on-demand disease-modifying therapies to empower patients in managing their conditions[71] - The company is updating its financial guidance, reflecting ongoing clinical trial progress and pipeline developments[80]

Financial Performance - As of December 31, 2023, GlycoMimetics reported cash and cash equivalents of $41.8 million, down from $47.9 million as of December 31, 2022[2][19]. - Research and development expenses for Q4 2023 decreased to $5.3 million, compared to $5.9 million in Q4 2022, and for the full year 2023, they decreased to $20.1 million from $28.4 million in 2022[9][17]. - General and administrative expenses for Q4 2023 decreased to $4.3 million from $4.7 million in Q4 2022, while for the full year, they slightly increased to $19.2 million from $19.1 million[13][17]. - The company reported a net loss of $9.1 million for Q4 2023, compared to a net loss of $10.2 million in Q4 2022[17]. - Shares of common stock outstanding as of December 31, 2023, were 64,393,744[13]. Clinical Development - The pivotal Phase 3 study of uproleselan in relapsed/refractory acute myeloid leukemia (AML) is expected to report topline results in Q2 2024[4][5]. - A New Drug Application (NDA) for uproleselan is planned to be submitted to the FDA by the end of 2024, contingent on positive outcomes from the pivotal study[5][9]. - The Phase 1a study of GMI-1687 met its primary and secondary endpoints, demonstrating safety and tolerability[5][9]. - A total of 388 patients were enrolled in the pivotal Phase 3 trial of uproleselan, with a median follow-up of over three years[9]. Leadership Changes - GlycoMimetics appointed Shantha Tyavanagimatt, Ph.D., as Senior Vice President of Technical Operations to strengthen its leadership team[7].

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].

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark one) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR (I.R.S. Employer Identification No.) (240) 243-1201 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-36177 GlycoMimetics, Inc. (Registrant's telephone number, i ...