Uproleselan

ROCKVILLE, Md.--( BUSINESS WIRE )--GlycoMimetics, Inc. (Nasdaq: GLYC) today announced that data from multiple clinical trials studying uproleselan in patients with acute myeloid leukemia (AML) have been accepted for presentation at the 66 th American Society of Hematology (ASH) Annual Meeting and Exposition taking place in San Diego, California, on December 7-10, 2024. ASH Annual Meeting abstracts may be accessed online at www.hematology.org . Details of GlycoMimetics presentations are as follows (all times PT): Publication Number: 733 Type: Oral Title: Efficacy and Safety of Uproleselan Combined with Chemotherapy Vs. Chemotherapy Alone in Relapsed/Refractory Acute Myeloid Leukemia: Findings from an International Phase 3 Trial Presenter: Daniel DeAngelo, M.D., Ph.D. Session Name: 616. Acute Myeloid Leukemias: Investigational Drug and Cellular Therapies: New Treatment Approaches for AML Session Date/ Presentation Time: Monday, December 9, 2024, 10:30 AM – 12:00 PM Publication Number: 1503 Type: Poster Title: Updated Results of a Phase I Study of Uproleselan Combined with Azacitidine and Venetoclax for the Treatment of Older or Unfit Patients with Treatment Naive Acute Myeloid Leukemia Presenter: Brian Jonas, M.D., Ph.D. Session Name: 616. Acute Myeloid Leukemias: Investigational Drug and Cellular Therapies: Poster I Session Date/ Presentation Time: Saturday, December 7, 2024, 5:30 PM - 7:30 PM Publication Number: 4262 Type: Poster Title: Final Results of a Phase II Study of Uproleselan Combined with Cladribine and Low-Dose Cytarabine for Patients with Treated Secondary Acute Myeloid Leukemia (ts-AML) Presenter: Caitlin Rausch, PharmD. Session Name: 616. Acute Myeloid Leukemias: Investigational Drug and Cellular Therapies: Poster III Session Date/Presentation Time: Monday, December 9, 2024, 6:00 – 8:00 PM About GlycoMimetics, Inc. GlycoMimetics is a late clinical-stage biotechnology company discovering and developing glycobiology-based therapies for cancers, including AML, and for inflammatory diseases. The company’s scientific approach is based on an understanding of the role that carbohydrates play in cell recognition. Its specialized chemistry platform can be used to discover small molecule drugs, known as glycomimetics, that alter carbohydrate-mediated recognition in diverse disease states, including cancers and inflammation. The company’s goal is to develop transformative therapies for diseases with high unmet medical need. GlycoMimetics is headquartered in Rockville, MD in the BioHealth Capital Region. Learn more at www.glycomimetics.com . Forward-Looking Statements To the extent that statements contained herein are not descriptions of historical facts, they are forward-looking statements reflecting the current beliefs and expectations of the management of GlycoMimetics, Inc. (“GlycoMimetics,” “we,” “us,” or “our”). Forward-looking statements include, but are not limited to, the expected presentation of clinical data for uproleselan, and any other statement containing terminology such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “intends,” or “continue,” or the negative of these terms or other comparable terminology. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels of activity, performance, or achievements to be materially different from those discussed, implied or otherwise anticipated by such statements. You are cautioned not to place undue reliance on such forward-looking statements, which are current only as of the date of this presentation. For a further description of the risks associated with forward-looking statements, as well as other risks facing GlycoMimetics, please see the risk factors described in the Company’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission on March 27, 2024 and the Company’s Quarterly Reports on Form 10-Q filed with the SEC on May 9, 2024 and August 8, 2024, as well as other reports we file with the U.S. Securities and Exchange Commission from time to time, including those factors discussed under the caption “Risk Factors” in such filings. Forward-looking statements speak only as of the date of this presentation, and GlycoMimetics undertakes no obligation to update or revise these statements, except as may be required by law.

It’s hard for preclinical biotech companies to go public these days as investors look for human data that can reduce investment risk. Crescent Biopharma is more than a year away from the clinic, but joining the public markets now enables the biotech to capitalize on a recent groundbreaking cancer drug development still fresh in investors’ minds. Crescent is going public in a reverse merger with GlycoMimetics, the companies announced Tuesday. When the transaction is complete, the merged entity will operate under the Crescent Biopharma name. It will be led by Jonathan Violin, Crescent’s current CEO, who is expected to become interim CEO of the combined company. Crescent will also be capitalized with $200 million from agreements with a select group of investors that have pledged to purchase the combined company’s securities. Those purchases will happen immediately after the merger closes in the second quarter of 2025. Crescent’s lead program is CR-001, a bispecific antibody in development for cancer. Most companies trying to build an investment case talk about how their drugs are differentiated from rivals. Crescent’s executives are doing the opposite, touting similarities to another drug: Summit Therapeutics’ ivonescimab. Last month, that drug posted data showing it topped the blockbuster Merck immunotherapy Keytruda in a head-to-head Phase 3 test. In patients with advanced cases of non-small cell lung cancer, treatment with ivonescimab led to a 49% reduction in the risk of disease progression or death compared to treatment with Keytruda, Summit said. Sponsored Post The Funding Model for Cancer Innovation is Broken — We Can Fix It Closing cancer health equity gaps require medical breakthroughs made possible by new funding approaches. By Eve McDavid - CEO of Mission-Driven Tech Keytruda is an antibody designed to block a particular checkpoint protein, which in turn enables immune cells to recognize and go after cancer cells. Ivonescimab, discovered by Summit’s China-based partner Akeso, is a bispecific antibody that blocks two targets: PD-1, the same receptor targeted by Keytruda, and the cancer-driving protein VEGF. Crescent’s CR-001 is also a bispecific antibody designed to block both of those targets. Speaking during a Tuesday conference call, Violin said his company’s drug replicates the properties of ivonescimab. Like Summit’s drug, Crescent’s bispecific antibody works by cooperative binding, meaning it is most active in the presence of both VEGF and PD-1. “This enables the molecule to deliver benefits to patients that are more than the sum of its parts, and to do so safely,” Violin said. “This novel format enables VEGF to create ‘daisy chains’ of drug molecule, linking them together and increasing the potency for PD-1 blockade. This unique design also may enable localization of drug to the tumor microenvironment, which may help reduce systemic toxicity.” CR-001 is undergoing the preclinical research that could support an investigational new drug application, which is expected in the fourth quarter of next year or early 2026. Assuming the application is cleared, preliminary clinical data could come in the second half of 2026, Violin said. Because CR-001 replicates the properties of Summit’s drug, Crescent believes data from a few dozen patients can “connect the dots” back to data from hundreds of ivonescimab-treated patients. “We know the ivonescimab data has catalyzed massive interest in advancing next-generation checkpoint inhibitor therapy — the PD1/PDL1 class is currently a $50 billion market and growing, so when something beats the leader of such a large and important drug class, we expect competition,” Violin said. “We anticipate this will be similar to what we have seen recently in the obesity field — and we believe we have the advantage of strategic design. CR-001 was crafted specifically to thread the same immunotherapy needle as ivonescimab, putting us in a strong competitive position.” presented by Health IT Accelerating Claim Processing: Strategies to Shorten the Life of a Claim These strategies and practices can significantly shorten the life cycle of claims, leading to quicker resolutions and improved financial outcomes. By Greenway Health Competition includes BioNTech and Instil Bio, both of which struck alliances in the past year with China-based companies for rights to bispecific antibodies that target both PD-1 and VEGF. Both programs are in clinical development in China. Crescent is the fifth company to emerge from Paragon Therapeutics, a firm that conducts biotechnology research and forms new companies around that science. The first Paragon spinout was Apogee Therapeutics, which emerged in late 2022 with a lead drug candidate in development for atopic dermatitis. Last year, Apogee raised more than $300 million in a traditional IPO that came ahead of the start of Phase 1 testing. Crescent’s pipeline of drugs from Paragon includes two preclinical antibody drug conjugates, CR-002 and CR-003. The company isn’t disclosing much detail about either program, but Violin said CR-002 “targets a highly compelling pathway” and the drug offers “the chance to be first in class.” GlycoMimetics was focused on developing treatments for cancer and inflammatory diseases with small molecules that inhibit carbohydrate interactions on the surface of cells. In July, FDA told the company its lead drug candidate, uproleselan, a potential treatment for advanced cases of acute myeloid leukemia, needed an additional clinical trial. Subsequently, the company laid off staff announced it would explore strategic alternatives. Crescent said it intends to determine potential paths forward for uproleselan. The private investment in the newly merged Crescent will be led by Fairmount, Venrock Healthcare Capital Partners, BVF Partners, and an unnamed “large investment management firm.” Other participants include Paradigm BioCapital, RTW Investments, Blackstone Multi-Asset Investing, Frazier Life Sciences, Commodore Capital, Perceptive Advisers, Deep Track Capital, Boxer Capital Management, Soleus, Logos Capital, Driehaus Capital Management, Braidwell LP, and Wellington Management. When the business combination closes, Crescent’s stockholders will own about 96.9% of the company; GlycoMimetics stockholders will own about 3.1%. Crescent believes its capital will be sufficient to last into 2027. By then, Crescent and its peers should have more data demonstrating how their respective bispecific antibody cancer drugs are working in patients. Photo by Flickr user Lengyal Mark via a Creative Commons license