On March 27, 2024 Adaptimmune Therapeutics plc (NASDAQ: ADAP), a company redefining the treatment of solid tumor cancers with cell therapy, reported that The Lancet published the company’s pivotal Phase 2 data with afami-cel (Press release, Adaptimmune, MAR 27, 2024, View Source [SID1234641514]). The article, titled "SPEARHEAD-1: a single-arm phase 2 trial of afamitresgene autoleucel (afami-cel) in advanced synovial sarcoma and myxoid/round cell liposarcoma," details clinical and translational results from afami-cel’s SPEARHEAD-1 trial (NCT04044768).

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Dennis Williams, PharmD., Senior Vice President, Late-Stage Development, Adaptimmune: "It is exciting to see the Lancet share the afami-cel SPEARHEAD-1 trial results in advanced sarcomas with the broader clinical and research communities. The study further demonstrates the ability of engineered T-cell therapies to effectively target solid tumors and we are eager to introduce the first engineered T-cell therapy, afami-cel, to more patients later this year."

Dr. Sandra D’Angelo, M.D., Sarcoma Medical Oncology, Memorial Sloan Kettering Cancer Center, lead author of the publication: "The reported findings are clinically impactful, considering the current standard of care and limited therapies available in advanced sarcomas. Treatment with afami-cel resulted in 39% overall response rate in synovial sarcoma with durable responses. These results suggest that a one-time treatment with afami-cel has the potential to extend life while allowing responders to go off chemotherapy. The publication of this data further validates the potential of afami-cel to offer a new tool to address the unmet needs of people diagnosed with these often-devastating diseases."

About Afami-cel (afamitresgene autoleucel): On January 31, 2024, Adaptimmune announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review its Biologics License Application (BLA) for afami-cel, an investigational engineered T-cell therapy for advanced synovial sarcoma. The application has a Prescription Drug User Fee Act (PDUFA) target action date of August 4, 2024.

In the SPEARHEAD-1 trial, 44 patients with advanced synovial sarcoma were treated with a single dose of afami-cel after undergoing lymphodepleting chemotherapy with cyclophosphamide and fludarabine. Safety findings were overall consistent with those previously observed in advanced cancer patients undergoing lymphodepleting chemotherapy and cell therapy. Haematologic toxicities were the most common adverse events. Low grade cytokine release syndrome occurred in most patients and was managed with standard treatments.

About Synovial Sarcoma: There are more than 50 different types of soft tissue sarcomas which are categorised by tumors that appear in fat, muscle, nerves, fibrous tissues, blood vessels, or deep skin tissues.1 Synovial sarcoma accounts for approximately 5% to 10% of all soft tissue sarcomas (there are approximately 13,400 new soft tissue cases in the U.S. each year).2 One third of patients with synovial sarcoma will be diagnosed under the age of 30.2 The five-year survival rate for people with metastatic disease is just 20% and most people undergoing standard of care treatment for advanced disease experience recurrence and go through multiple lines of therapy, often exhausting all options.3

View Source
Synovial Sarcoma – NCI (cancer.gov).
Aytekin MN, et al. J Orthop Surg (Hong Kong). 2020;28(2).

On March 27, 2024 LIXTE Biotechnology Holdings, Inc. ("LIXTE" or the "Company") (Nasdaq: LIXT and LIXTW), a clinical stage pharmaceutical company, reported publication of pre-clinical data in the online journal, Cancer Discovery, showing that its lead clinical compound, LB-100, can force cancer cells to give up their cancer-causing properties in a paper entitled "Paradoxical activation of oncogenic signaling as a cancer treatment strategy (Press release, Lixte Biotechnology, MAR 27, 2024, View Source [SID1234641569])." The finding opens a potentially new treatment strategy in addition to LIXTE’s current three clinical trials.

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As will be published in the July 2024 issue and posted online today, LB-100 was shown to trigger hyper-activation of the signals that are responsible for the deregulated proliferation of cancer cells, which is the opposite of most of the current generation of cancer therapies. The deliberate hyper-activation of cancer signals becomes lethal when combined with an inhibitor of the WEE1 kinase. This well-tolerated combination proved to be highly effective in killing colon cancer cells in animal models of cancer and in cell culture.

Resistance to therapy is the leading cause of death due to cancer. Resistance to LB-100 therapy, however, has been shown to be associated with cancer cells becoming less malignant. Specifically, colon cancer cells that developed resistance to LB-100 had lost many of the features that make the cells cancerous in the first place and were unable to form tumors in experimental animal models.

This "tumor suppressive drug resistance" stems from the unique features of LB-100. Although cancer-causing signals force cancer cells to become more cancerous, the hyper-activation of these signals by LB-100 forces cancer cells to suppress these signals and thus become less cancerous.

The team of scientists reporting these findings was headed by Professor René Bernards at the Netherlands Cancer Institute and Oncode Institute, Amsterdam. Professor Bernards is a a leader in the field of molecular carcinogenesis and is a member of the Board of Directors of LIXTE.

Bas van der Baan, Chief Executive Officer of LIXTE, said, "The effect of LB-100 on cancer cells is unique in that the only way for cancer cells to escape death is to evolve toward a less cancerous behavior. We look forward to testing this concept clinically, which is distinct from the well-characterized enhancement of checkpoint immunotherapy and chemotherapy by LB-100 currently being tested in three clinical trials."

On March 27, 2024 Evaxion Biotech A/S (NASDAQ: EVAX) ("Evaxion" or the "Company"), a clinical-stage TechBio company specializing in developing AI-Immunology powered vaccines, reported a business update and announces full year 2023 financial results (Press release, Evaxion Biotech, MAR 27, 2024, View Source [SID1234641494]).

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Christian Kanstrup, Chief Executive Officer at Evaxion, commented: "We have made significant progress in our business and our financing strategies in recent months, notably the successful closing of our bridge financing round towards the end of 2023 and a subsequent public offering in early February 2024. We are very pleased with the MSD GHI participation in both financing rounds, following which we now have cash at hand into Q1 2025."

Christian continues: "With our refined strategy centered around AI-Immunology focusing on value realization via Targets, Pipeline and Responders based upon a muti-partner approach, we are enthusiastic about the prospects this brings for 2024. Further, we are executing to progress our ambition to fund our projected $14 million operational cash burn for 2024 through revenue generated from our business development activities."

Business Updates Since Last Quarterly Update

In January 2024, Evaxion announced it had commenced developing tailored novel cancer vaccines using the AI-Immunology platform. The initiative involves a new category of AI-identified tumor vaccine targets, ERVs, and aims to obtain preclinical Proof-of-Concept by the second half of 2024. With the AI-Immunology discovered novel cancer targets, designing personalized and precision vaccines may become feasible. This approach holds the potential to provide treatment solutions for cancer patients who typically do not respond to cancer immunotherapy.

In February 2024, the initial phases of an ongoing vaccine collaboration with MSD were successfully completed. The collaboration was initiated in September 2023, and in February 2024 MSD was revealed as the pharma partner for the EVX-B3 vaccine collaboration in connection with the collaboration update. The project aims to develop a vaccine against a bacterial pathogen responsible for a pressing global medical issue, lacking preventive or curative options.

Evaxion hosted an R&D Day on March 19, 2024, providing deeper insights into the validated and differentiated AI-Immunology platform. Key takeaway messages from the day were:

The proprietary AI-Immunology platform brings the potential for a new era in vaccine discovery, design and development using advanced AI and machine learning technologies.
AI-Immunology outcompetes standard vaccine target discovery approaches and holds the promise of addressing serious unmet needs.
With a unique modular architecture, AI-Immunology is scalable and adaptable towards partner needs.
The potential of AI-Immunology is validated by established partnerships, including the ongoing vaccine collaboration with MSD.
In the initial months of 2024, we showcased our differentiated AI-Immunology platform for vaccine target discovery, design and development, alongside our refined strategy for value generation, at the following conferences:

January 8-11: CEO Christian Kanstrup attended the 42nd annual J.P. Morgan Healthcare Conference.
February 27: Chief AI Officer, Andreas Holm Mattsson, participated in a panel discussion at the Sachs Associates 5th Annual European HealthTech CEO Forum.
February 28: CEO Christian Kanstrup presented the Sachs Associates 17th Annual European Life Sciences CEO Forum.
March 7: VP of AI & Innovation, Jens Kringelum, presented the 5th Biologics World Nordics 2024 Conference.
March 7: CEO Christian Kanstrup and CSO Birgitte Rønø participated in a fireside chat at the H.C. Wainwright 1st Annual Artificial Intelligence Based Drug Discovery & Development Virtual Conference.
March 7-8: Senior Project Manager, Immuno-oncology, Daniela Kleine-Kohlbrecher, presented at the 8th Annual MarketsandMarkets Next-Gen Immuno-Oncology Conference.

Anticipated 2024 Milestones
Milestones Target
EVX-B1 Conclusion of final MTA study with potential partner Q1 2024
AI-Immunology Launch of EDEN model version 5.0 Mid 2024
EVX-B2-mRNA EVX-B2-mRNA preclinical Proof-of-Concept obtained Q3 2024
EVX-01 Phase 2 one-year readout Q3 2024
EVX-B3 Conclusion of target discovery and validation work in collaboration with MSD (tradename of Merck & Co., Inc., Rahway, NJ, USA) H2 2024
Precision ERV cancer vaccines Preclinical Proof-of-Concept obtained H2 2024
Funding Ambition for full year 2024 is to generate business development income equal to 2024 cash burn (excluding financing activities) of $14 million*
* No assurances can be made that we will generate such business development income
Full Year 2023 Financial Results

Cash position: As of December 31, 2023, cash and cash equivalents were $5.6 million compared to $13.2 as of December 31, 2022. Cash position was strengthened by a private placement with gross proceeds of $5.3 million, which closed on December 21, 2023. The private placement included participation from existing and new shareholders, with the largest new shareholder being MSD Global Health Innovation Fund (MSD GHI), a corporate venture capital arm of Merck & Co., Inc., Rahway, NJ, USA, accounting for some 25% of the total aggregate offering amount. Further, the Private Placement included significant participation by all members of the Company’s management and the Company’s board of directors. After a public offering in February 2024, resulting in net proceeds of $12.7 million, we expect that our existing cash and cash equivalents will be sufficient to fund our operating expenses and capital expenditure requirements into February 2025. If all pre-funded warrants included in the public offering are exercised, we expect necessary funding will be in place into April 2025.
Research and Development expenses were $11.9 million for the year ended December 31, 2023, as compared to $17.1 million for the year ended December 31, 2022. The decrease was primarily due to a reduction in external costs.
General and Administrative expenses were $10.4 million for the year ended December 31, 2023, as compared to $8.2 million for the year ended December 31, 2022. The increase was primarily due to an increase in external costs in connection with funding activities.
Net loss was $22.1 million for the year ended December 31, 2023, or ($0.81) per basic and diluted share, as compared to a net loss of $23.2 million, or ($0.98) per basic and diluted share for the year ended December 31, 2022.
Based on the Company’s current cash position, with an estimated cash runway into February 2025 and the need for further funding, it is the assessment of management that there exists substantial doubt about the Company’s ability to continue as a going concern.

Webcast

Evaxion will host a Business Update and Full Year 2023 Financial Results webcast on Tuesday, April 2, at 15:00 CEST / 9:00 a.m. EDT. To join the conference call, listen to the presentation and ask verbal questions, please register in advance via this link to receive the dial-in telephone numbers and a unique pin code. The call can be accessed 15 minutes prior to the start of the live event. To join the webcast, please click on this link. The webcast recording will be available shortly after the event.

Evaxion Biotech A/S
Consolidated Statement of Financial Position Data (Audited)
(USD in thousands)
Dec 31,
2023 Dec 31,
2022

Cash and cash equivalents $ 5,583 $ 13,184
Total assets 12,889 22,025
Total liabilities 17,618 13,722
Share capital 5,899 3,886
Other reserves 97,342 90,262
Accumulated deficit (107,970) (85,845)
Total equity (4,729) 8,303
Total liabilities and equity $ 12,889 $ 22,025

Evaxion Biotech A/S
Consolidated Statement of Comprehensive Loss Data (Audited)
(USD in thousands, except per share data)

Three Months Ended
December 31,
Twelve Months Ended
December 31,
2023 2022 2023 2022


Revenue $ 73 $ — $ 73 $ —
Research and development (2,298) (4,073) (11,916) $ (17,056)
General and administrative (2,138) (2,452) (10,354) (8,208)

Operating loss (4,363) (6,525) (22,197) (25,264)
Finance income 559 70 963 2,831
Finance expenses (895) (590) (1,681) (1,508)

Net loss before tax $ (4,699) $ (7,045) $ (22,915) $ (23,941)

Income tax benefiT 177 173 790 772

Net loss for the period $ (4,522) $ (6,872) $ (22,125) $ (23,169)

Net loss attributable to shareholders of Evaxion Biotech A/S $ (4,522) $ (6,872) $ (22,125) $ (23,169)

Loss per share – basic and diluted $ (0.16) $ (0.29) $ (0.81) $ (0.98)
Number of shares used for calculation (basic and diluted) 29,061,036 24,082,247 27,335,829 23,638,685

On March 27, 2024 Medigene AG (Medigene or the "Company", FSE: MDG1, Prime Standard), an immuno-oncology platform company focusing on the discovery and development of T cell immunotherapies for solid tumors, reported financial results for the fiscal year ended December 31, 2023, and provided a corporate update (Press release, MediGene, MAR 27, 2024, View Source [SID1234641515]).

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Select FY 2023 financial results

Revenues amounted to EUR 6.0 million, a decrease of 81% (or EUR 25.2 million) compared to EUR 31.2 million in 2022. Higher revenues in 2022 were due to the comprehensive TCR-T and technology partnership with BioNTech concluded in February 2022, resulting in EUR 20.9 million in product revenues. In addition, revenues from the partnerships with 2seventy bio and Hongsheng Sciences were generated in 2022.

Selling expenses decreased from EUR 2.2 million in 2022 to EUR 20 thousand in 2023. This decrease is due to the above-mentioned partnership with BioNTech and the related costs incurred in the first half of 2022 as part of the preparation process leading up to the agreement.

General and administrative (G&A) expenses were EUR 9.3 million in 2023 compared to EUR 7.7 million in the year prior. This 21% increase was mainly due to higher personnel and consulting expenses as the Company supported its strategic efforts to advance all scientific and partnering activities.

Research and development (R&D) expenses decreased by 59% to EUR 11.5 million (2022: EUR 28.5 million) and reflect the work associated with the development of T cells for the treatment of solid tumors and pre-clinical development activities. The significant decrease in 2023 is mainly due to depreciation related to the full impairment of the drug candidate RhuDex, out-licensed to Dr. Falk Pharma GmbH for the amount of EUR 20.4 million in 2022. R&D expenses incurred in the collaborations with partner companies are reimbursed by the companies. The reimbursements are recognized as R&D payments in immunotherapies revenue.

Net loss for fiscal 2023 increased to EUR 16.2 million compared to EUR 8.3 million in 2022. The increase is due to the described partnership with BioNTech in February 2022 and the associated revenues.

Cash and cash equivalents amounted to EUR 8.7 million and time deposits for EUR 8 million, totaling EUR 16.7 million on Dec 31, 2023 (Dec 31, 2022: EUR 33.2 million), with a cash runway extended into April 2025 (previously Q1 2025).

"2023 was a highly productive year for Medigene. We have made significant progress in broadening our pipeline into TCR-T therapies targeting KRAS mutations, which represent one of the most frequent neoantigens in solid cancers. We significantly advanced our End-to-End (E2E) Platform, adding new technologies such as the CD40L-CD28 costimulatory switch protein, and with a focus on improving our drug product composition to enable better efficacy, safety and durability. This was reflected by an increase in the size and scope of our patent portfolio," said Selwyn Ho, Chief Executive Officer of Medigene. "Importantly, we advanced our lead program MDG1015 towards a first-in-human clinical trial, which is expected by the end of 2024 subject to financing. This first-in-human trial will target patients with gastric cancer, ovarian cancer, myxoid/round cell liposarcoma and synovial sarcoma as the initial clinical indications."

"In 2024, we will continue to advance our differentiated TCR-T therapies for the treatment of solid tumors. Using our core expertise and ability to generate optimal TCRs, we will also aim to apply these to new TCR-based modalities beyond TCR-T cell therapies, such as off-the shelf T cell engagers and allogeneic TCR-Natural Killer cells, where further value could be created for patients and our shareholders. We believe that these additional potential therapeutic options represent highly promising commercial opportunities for Medigene."

Financial Guidance 2024

The 2024 financial projections include potential future milestone payments from existing partnerships that are highly likely to materialize in the amount of USD 1 million and EUR 2 million, respectively. They do not include potential milestone payments from or future/new partnerships or new transactions as the occurrence of such payments or their timing and size largely depend on third parties and cannot be controlled or influenced by Medigene.

As such, the 2024 financial guidance reflects the Company’s focus and progress in its core immunotherapies business.

Based on the above assumptions, Medigene expects revenue in 2024 to be between EUR 9 and 11 million. The Company expects R&D costs to range from EUR 11 to 13 million. And as already mentioned, based on current planning, the Company is funded into April 2025.

Program development highlights

MDG1015: MDG1015 is a first-in-class, third generation T cell receptor engineered T cell (TCR-T) therapy targeting NY-ESO-1/LAGE-1a (New York esophageal squamous cell carcinoma 1 / L Antigen Family Member-1a), armored and enhanced by the costimulatory switch protein PD1-41BB and targeting HLA-A*02 (HLA, human leukocyte antigen). Preclinical data presented in 2023 at the AACR (Free AACR Whitepaper) and ESMO (Free ESMO Whitepaper) conferences demonstrated the clear potential of MDG1015 to improve clinical outcomes in solid tumors.

Following recent positive EU and US preliminary regulatory interactions, the Company remains on track for an IND/CTA approval in the second half of 2024. Subject to financing, the Company expects to initiate a first in-human trial for MDG1015 by the end of 2024.

MDG2011: MDG2011 is a potential best-in-class third generation TCR-T therapy targeting KRAS G12V (HLA-A*11), further armored and enhanced by the PD1-41BB costimulatory switch protein. First pre-clinical data on MDG2011 was presented at the ESMO (Free ESMO Whitepaper) Congress 2023 and the SITC (Free SITC Whitepaper) Annual Meeting 2023. Lead selection for MDG2011 was announced in the third quarter 2023.

MDG2021 and MDG2012: MDG2021 is our second candidate within the KRAS library targeting KRAS G12D (HLA-A*11) with lead selection expected in the first half of 2024. The lead selection for the Company’s third announced KRAS-targeted program MDG2012, KRAS G12V (HLA-A*03), is expected in 2025.

Corporate development highlights

To support the development of our research projects, we have established a partnership network with both, well-known biotechs and renowned academic bodies.

In April 2023, Medigene entered into a joint collaboration with the US National Cancer Institute to assess the potential of Medigene’s proprietary TCRs for use in new cell constructs in the treatment of solid tumors.

The Company’s existing partnerships with BioNTech and 2seventy bio are progressing well.

In January 2023, Medigene received a USD 3 million milestone payment from its partner 2seventy bio triggered by 2seventy bio’s initiation of a strategic partnership with JW Therapeutics in December 2022.

Expansion of patent portfolio

The advancement of its E2E Platform allowed the Company to extend and strengthen its patent portfolio with new technologies as well as to expand existing patents into additional jurisdictions, such as the costimulatory switch proteins for use in multiple cell types and their geographical coverage. As of Dec 31, 2023, Medigene’s IP portfolio consisted of 112 issued and 131 pending patents across 28 patent families.

Conference Call and Webcast

The Company will host a conference call and webcast today at 3 pm CET / 10 am ET. A Q&A session will follow the management’s formal presentation.

Full details for the conference call and webcast are as follows:

Date March 28, 2024
Time 3:00 p.m. CET (10 a.m. ET)
Conference ID: 20240088
Registration Conference Call: Registration Conference Call here
Webcast: Join the live webcast here
Participants may pre-register and will receive dedicated dial-in details to easily and quickly access the call with the above registration link for the conference call.

Please dial in 10 minutes ahead of time to ensure a timely start of the conference call.

Following the call, an archived webcast will be accessible on the Investors & Media section of the Medigene website: View Source

On March 27, 2024 GlycoMimetics, Inc. (Nasdaq: GLYC), a late clinical-stage biotechnology company discovering and developing glycobiology-based therapies for cancers and inflammatory diseases, reported its financial results and highlights for the quarter and year ended December 31, 2023. Cash and cash equivalents as of December 31, 2023, were $41.8 million (Press release, GlycoMimetics, MAR 27, 2024, View Source [SID1234641495]).

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"With the time-based analysis imminent for our pivotal Phase 3 study of uproleselan in R/R AML, we are laser-focused on delivering the topline results in Q2 and excited about the possibility of submitting an NDA before year-end. This large, randomized, global trial now has a median follow-up of more than three years, which is remarkable in R/R AML, and could demonstrate the potential of uproleselan to become a new standard of care for a disease with limited treatment options and high unmet need," said Harout Semerjian, Chief Executive Officer of GlycoMimetics. "We are also pleased to announce our agreement with the ASH (Free ASH Whitepaper) RC for GMI-1687, further validating the potential of this highly potent E-selectin antagonist for the treatment of sickle cell disease. We remain deeply committed to bringing life-changing treatments to patients and look forward to sharing more important updates in the coming months."

Operational Highlights

Uproleselan

In June 2023, GlycoMimetics announced FDA clearance of a protocol amendment to the company’s pivotal Phase 3 study of uproleselan for R/R AML. This amendment provides for a time-based analysis of the primary endpoint of overall survival after a defined cutoff date, if the 295 survival events of the originally planned event-driven analysis have not been observed by that date. With adoption of the time-based analysis, the company expects to report topline results in Q2 2024.
A total of 388 patients across 70 sites in nine countries were enrolled and randomized in the pivotal Phase 3 trial, which has a primary endpoint of overall survival. The time-based analysis dataset will reflect a median follow-up in patients remaining on study of more than three years, underscoring the potential utility of uproleselan in R/R AML.
The National Cancer Institute (NCI) Alliance for Clinical Trials in Oncology will conduct an analysis of event-free survival in 267 patients enrolled and randomized in its Phase 2/3 clinical trial (NCI protocol A041701) evaluating uproleselan in newly diagnosed older adults with AML who are fit for chemotherapy. Enrollment of the Phase 2 portion of the study was completed in December 2021. The company reiterates that when available, it will share these results.
GMI-1687

In August 2023, GlycoMimetics initiated a Phase 1a single-center, double-blind, randomized, placebo-controlled, sequential, single ascending dose trial in healthy adult volunteers. The study enrolled 40 subjects. Eligible subjects received a single dose of GMI-1687 or placebo (6:2 ratio) via subcutaneous injection. In January 2024, the company announced that the study met its primary and secondary endpoints of safety/tolerability and pharmacokinetics. There were no dose-limiting toxicities or other safety signals. Potentially therapeutic plasma levels that may alleviate vaso-occlusive events (VOE) were achieved at multiple dose levels after a single injection. Full study results of this Phase 1a first-in-human trial of GMI-1687 will be presented at an upcoming medical meeting.
GlycoMimetics announced today that it has entered into a research agreement with the ASH (Free ASH Whitepaper) RC and its Sickle Cell Disease Research Network. This collaboration will obtain feedback on the GMI-1687 clinical development plan from people living with sickle cell disease and therapeutic area experts. ASH (Free ASH Whitepaper) RC fosters partnerships to accelerate progress and improve outcomes for people living with SCD by expediting therapeutics development and generating high-quality evidence to support clinical decision-making.
Corporate Update

GlycoMimetics strengthened its leadership team by appointing Shantha Tyavanagimatt, Ph.D., as Senior Vice President of Technical Operations.
Fourth Quarter and Full Year 2023 Financial Results

Cash position: As of December 31, 2023, GlycoMimetics had cash and cash equivalents of $41.8 million, compared to $47.9 million as of December 31, 2022.
R&D Expenses: The company’s research and development expenses decreased to $5.3 million for the quarter ended December 31, 2023, compared to $5.9 million for the fourth quarter of 2022. Research and development expenses for the year ended December 31, 2023, decreased to $20.1 million, compared to $28.4 million in the prior year. These decreases were due to lower clinical development expenses for the global Phase 3 clinical trial of uproleselan in individuals with relapsed/refractory AML, and decreased manufacturing costs due to the completion of engineering and validation batches for uproleselan, partially offset by the Phase 1 clinical trial of GMI-1687.
G&A Expenses: The company’s general and administrative expenses decreased to $4.3 million for the quarter ended December 31, 2023, compared to $4.7 million for the fourth quarter of 2022. General and administrative expenses for the year ended December 31, 2023, increased slightly to $19.2 million, compared to $19.1 million in the prior year. The overall increase was due to higher personnel-related expenses, offset in part by a decrease in external consulting expenses.
Shares Outstanding: Shares of common stock outstanding as of December 31, 2023, were 64,393,744.
Conference Call Information

The company will host a conference call and webcast today at 8:30 a.m. ET. To access the call by phone, please go to this registration link and you will be provided with dial in details. Participants are encouraged to connect 15 minutes in advance of the scheduled start time.

A live webcast of the call will be available on the "Investors" tab on the GlycoMimetics website. A webcast replay will be available for 30 days following the call.

About Uproleselan

Discovered and developed by GlycoMimetics, uproleselan is an investigational, first-in-class E-selectin antagonist. Uproleselan (yoo’ pro le’se lan) is currently being evaluated in a broad development program, including a late-stage Phase 3 trial in acute myeloid leukemia (AML), GlycoMimetics has received Breakthrough Therapy and Fast Track designations from the FDA and Breakthrough Therapy designation from the Chinese National Medical Products Administration for uproleselan as a potential treatment for adult AML patients with relapsed or refractory disease. Uproleselan is designed to block E-selectin binding and stimulation of myeloid cells. E-selectin is expressed on the surface of blood vessels, and its binding to myeloid cells is believed to confer a pro-survival effect. Uproleselan is intended to enable a novel approach to disrupting established mechanisms of leukemic cell resistance.

About GMI-1687

Discovered and developed by GlycoMimetics, GMI-1687 is a highly potent E-selectin antagonist that is bioavailable after subcutaneous administration. This second-generation compound has potential application in inflammatory diseases, and the company’s initial clinical development will focus on SCD. E-selectin is believed to play a major role in vaso-occlusive events (VOEs), a group of acute complications that are associated with SCD and include vaso-occlusive pain crises, acute chest syndrome (ACS), stroke, and splenic sequestration. Administration of GMI-1687 by subcutaneous injection, if successfully developed in the clinic, may enable this study drug to be approved as a patient-controlled, point-of-care treatment option.