glyc_Current_Folio_8K

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

 


 

FORM 8‑K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

The Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported):  July 23, 2018

 


 

GlycoMimetics, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

 

 

 

Delaware

 

001-36177

 

06-1686563

(State or other jurisdiction of incorporation)

 

(Commission File Number)

 

(IRS Employer
Identification No.)

 

9708 Medical Center Drive

Rockville, MD 20850

(Address of principal executive offices, including zip code)

 

(240) 243-1201

(Registrant’s telephone number, including area code)

 

N/A

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

[  ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

[  ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

[  ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

[  ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Indícate by check mark whether the registrant is an emerging growth Company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter)  or Rule 12b‑2 of the Securities Exchange Act of 1934 (§240.12b‑2 of this chapter).

 

Emerging growth company ☑

 

If an emerging growth company,  indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☑

 

 

 


 

Item 7.01     Regulation FD Disclosure.

 

On July 23, 2018, GlycoMimetics, Inc. (the “Registrant”) was notified by its collaborator Pfizer Inc., the company responsible for ongoing clinical development of the Registrant’s drug candidate rivipansel, that the ongoing Phase 3 trial with rivipansel is approximately 75% enrolled and that Pfizer now expects to complete enrollment in early 2019 and to have top line data available in the second quarter of 2019. Pfizer had previously announced its expectation to complete enrollment in the second half of 2018 and to have preliminary results available by the end of 2018.

 

The Registrant has updated its corporate presentation accordingly.  A copy of the updated presentation is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is also available on the Registrant’s website at http://ir.glycomimetics.com/investor-relations.

 

The information in this Item 7.01 of this Current Report on Form 8-K (including Exhibit 99.1) is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

 

Item 9.01 Financial Statements and Exhibits. 

 

(d) Exhibits

 

 

 

Exhibit

 

 

Number

 

Exhibit Description

99.1

 

GlycoMimetics Corporate Presentation, dated July 2018.

 

 

2


 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  

 

 

 

 

GLYCOMIMETICS, INC.

 

 

 

 

By:  

/s/ Rachel K. King

Date:  July 25, 2018

 

Rachel K. King
Chief Executive Officer

 

 

3


glyc_Ex99_1

Exhibit 99.1

 

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Innovation Today, Healing Tomorrow. July 2018 CORPORATE OVERVIEW NASDAQ: GLYC GlycoMimetics, Inc.


 

 

 

 

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To the extent that statements contained in this presentation are not descriptions of historical facts regarding GlycoMimetics, Inc. (“GlycoMimetics,” “we,” “us,” or “our”), they are forward-looking statements reflecting management’s current beliefs and expectations. 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 anticipated by such statements. You can identify forward-looking statements by 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 contained in this presentation include, but are not limited to, statements regarding: (i) the expected timing of completion and data readout of the ongoing Phase 3 clinical trial of Rivipansel by Pfizer Inc. (ii) the timing of receipt of clinical data for our drug candidates; (iii) our expectations regarding the potential safety, efficacy, or clinical utility of our drug candidates; (iv) the size of patient populations targeted by drug candidates we or our collaborators develop and market adoption of our potential drugs by physicians and patients; (v) the likelihood and timing of regulatory filings and approvals; and (vi) our cash needs and expected cash runway, as well as potential royalties and milestone payments under license and collaboration agreements. Various factors may cause differences between our expectations and actual results, including unexpected safety or efficacy data, unexpected side effects observed during preclinical studies or in clinical trials, lower than expected enrollment rates in clinical trials, changes in expected or existing competition, changes in the regulatory environment for our drug candidates, failure of our collaborators to support or advance our collaborations or drug candidates, our need for future capital, the inability to protect our intellectual property, and the risk that we become a party to unexpected litigation or other disputes. 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 6, 2018, 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. 2 Forward-Looking Statements GlycoMimetics, Inc.


 

 

 

 

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Maturing Clinical Pipeline with Near-Term Catalysts Phase 3 enrollment completion expected 1Q 2019: Vaso-occlusive crisis (VOC) of sickle cell disease Robust Phase 2 results across all endpoints Collaboration agreement with Pfizer Pfizer projects “potential blockbuster” (possible peak sales > $1B) GLYC milestones and royalties from low double digit to low teens Phase 3 registration trial begins Q3 2018: Acute myeloid leukemia Breakthrough Therapy Designation granted in May 2017 IP through 2032, US & EU, pending in Japan Targeting top-line data 4Q 2020 Strong international KOL support; two consortia-funded trials Strong balance sheet; funded through multiple catalysts / milestones March 31, 2018 cash balance $240+ million Well positioned to drive value creation Pipeline of potentially ‘game changing’ therapeutic opportunities 3 GlycoMimetics, Inc.


 

 

 

 

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Rivipansel (GMI-1070) for Sickle Cell Crisis Phase 3 Enrollment Completion Expected 1Q 2019 4 GlycoMimetics, Inc.


 

 

 

 

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Sickle Cell Vaso-Occlusive Crisis and Rivipansel Mechanism of Action 5 Sickled red blood cells (SS-RBCs) and other pro-inflammatory factors produce selectins (adhesion molecules) Selectins bind immune cells to the endothelium; activate, trap circulating SS-RBCs; create VOC Rivipansel selectively targets underlying pathophysiology Pan-selectin antagonist Disrupts tethering of adherent cells to activated endothelium Restores normal blood flow to alleviate VOC Hassell KL. (2010) Am J Prev Med.;38(4 Suppl):S512-21 Brousseau D et. al. (2010) Am J Hematol. 85(1) 77-8 Resulting ischemia, excruciating pain, necrosis and organ damage GlycoMimetics, Inco.


 

 

 

 

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Prevalence of Sickle Cell Anemia in Major Markets 6 Source: WHO, http://www.who.int/mediacentre/factsheets/fs308/en; CDC, http://www.cdc.gov/ncbddd/sicklecell/data.html, Accessed May 2016. Brousseau et al. The number of people with sickle cell disease in the United States: national and state estimate, 2010.; Lucas et al. NCEPOD report, 2008. Gluckman et al. International Sickle Cell Disease Observatory, 2010; Kunz et al. Significant prevalence of sickle cell disease in Southwest Germany, 2016; Grosse et al. The Prevalence of Sickle Cell Disease and its Implication for Newborn Screening in Germany, 2016; Lobitz et al. Incidence of sickle cell disease in Berlin, Germany, 2014; Bardakdijan et al. Neonatal Screening for sickle cell disease in France, 2009; Colombatti er al. Organizing national responses for rare blood disorders in Italy, 2013; AlJuburi et al. Trends in hospital admissions for sickle cell disease, 2010; Kingdom of Saudi Arabi Ministry of Health Announcement as part of World Sickle Cell Day June 26, 2015; REDS III International Program – Brazil (Version 2018-01-18 Final) 100,000 145,000 30,000 ~55,000 Prevalence United States Saudi Arabia France Germany United Kingdom Spain Italy Brazil GlycoMimetics, Inc.


 

 

 

 

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Phase 3 “RESET” Study Design 7 Key Eligibility Criteria ≥ 6 years in age History of SCD Hospital admission and IV narcotics for VOC Rivipansel Q12 hours (n=175) 1:1 Randomization Placebo Q12 hours (n=175) Day 35 Post-Discharge Follow-Up Discharge form Hospital Primary Outcome Measure: Time to readiness-for-discharge (readiness-for-discharge date/time vs start date/time of first infusion) GlycoMimetics, Inc.


 

 

 

 

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High Confidence in Rivipansel “RESET” Phase 3 Program Biologically relevant VOC target: selectin inhibition GlycoMimetics’ randomized Phase 2 trial of Rivipansel Selexys randomized Phase 2 of SelG1 (p-selectin antibody) Phase 3 primary endpoint modelled on Phase 2 data Simple checklist; more rigorous evaluation Well powered; more than three times size of Phase 2 Special Protocol Assessment in effect with FDA 8 GlycoMimetics, Inc.


 

 

 

 

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Phase 2 Results – Substantial Improvements Observed Across Clinically Relevant Endpoints 9 Rivipansel Placebo Probability Time to Resolution (Hours) 0 50 100 150 200 1.0 0.8 0.6 0.4 0.2 0.0 Median time to resolution of VOC reduced by 63 hours (p=0.187; Kaplan-Meier) Rivipansel Placebo Probability Time to Discharge (Hours) 0 50 100 150 200 1.0 0.8 0.6 0.4 0.2 0.0 Median time to discharge reduced by 84 hours (p=0.092; Kaplan-Meier) Time to Discharge From Hospital Time to Resolution of VOC GlycoMimetics, Inc.


 

 

 

 

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Phase 2 Results - Significant Reduction in Opioid Use Hourly IV Opioid Use Mean Hourly Opioid Use Rivipansel Placebo 24 hour reduction p<0.001 *** Cumulative opioid analgesic administered reduced by 83% (p=0.010) 10 Median time to transition to oral pain meds reduced by 76 hours (p=0.089; Kaplan-Meier) Probability Time to Transition (Hours) Opioid Use Over Time Time to Transition to Oral Analgesics Rivipansel Placebo 0.0 0.2 0.4 0.6 0.8 1.0 Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 GlycoMimetics, Inc.


 

 

 

 

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Rivipansel Potential Life Cycle 11 Hassell KL. (2010) Am J Prev Med.;38(4 Suppl):S512-21 Brousseau D et. al. (2010) Am J Hematol. 85(1) 77-8 Yusuf HR et. al. (2010) Am J Prev Med. 38(4 0) Market expansion opportunity: Outpatient & Emergency Rooms “O-demand” agent vs Historical noncompliance with chronic, prophylactic therapy Setting of Care Home Outpatient Setting Emergency Department Inpatient Hospital Potential Use of Rivipansel -- Potential use in patients destined for admission to abort VOC episode & prevent organ damage Initial Indication -- ~140,000 Events/Year 3 80-100,000 Events/Year 1,2 0-6 hours 2-24 hours 12 hours - 5+ days Prodrome Moderate-Severe Pain Uncontrollable Pain and Other Complications Progression of a Vaso-Occlusive Crisis (VOC) GlycoMimetics, Inc.


 

 

 

 

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Rivipansel: Attractive Commercial Opportunity 12 High unmet needs - unlikely to change in future Only “on-demand” treatment in development Potential standard of care for VOC Similar treatment patterns: US, EU, other markets Global commercial alignment Concentrated target audience Commercialization with small, focused sales infrastructure Global market opportunity is sizeable Pfizer “blockbuster” projection (>$1B US) GlycoMimetics, Inc.


 

 

 

 

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Tiered, ranging from low double digits to low teens Regulatory: Up to $70.0 million possible: Next milestones - Acceptance of NDA - Acceptance of filing by EMA Development: Up to $80 million possible remaining: Next milestones - First commercial sale in US - First commercial sale in Europe Commercial: Up to $135.0 million possible: Pfizer responsible for all further clinical development, regulatory approval and potential commercialization for all indications worldwide Rights UpcomingMilestones Royalties Pfizer Partnership - Near Term Economics 13 GlycoMimetics, Inc.


 

 

 

 

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GMI-1271 (Uproleselan) Breakthrough Therapy Designation Significant Market Opportunity 14 GlycoMimetics, Inc.


 

 

 

 

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Significant Opportunity to Treat Patients Across the Continuum of Care in AML 15 Fit patients eligible for intensive therapy Less-fit patients eligible for low-intensity therapy 1 GlobalData AML Opportunity Analysis and Forecast Report published in 2016 ~44,000 Patients1 (Annual Diagnosis Rates in 7 Major Markets) Relapsed / Refractory Combination of GMI-1271 + Salvage Chemotherapy (e.g. MEC) Newly Diagnosed/ Fit for Chemotherapy Combination of GMI-1271 + 7&3 Newly Diagnosed Unfit / Vulnerable Combination of GMI-1271 + Hypomethylating Agent (e.g. Vidaza) Potential Expanded Label & Commercial Opportunity Differentiated Clinical Strategy GlycoMimetics, Inc.


 

 

 

 

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ASH 2017: Phase 2 Results 16 GMI-1271 improves efficacy and safety of chemotherapy in R/R and newly diagnosed older patients with AML: results of a Phase 1/2 study Daniel J. DeAngelo, Brian A. Jonas, Jane L. Liesveld, Dale L. Bixby, Anjali S. Advani, Paula Marlton, Michael E. O’Dwyer, John L. Magnani, Helen M. Thackray, Pamela S. Becker Dana-Farber Cancer Institute, Boston, MA; UC Davis Comprehensive Cancer Center, Sacramento, CA; U of Rochester School of Medicine and Dentistry, Rochester, NY; University of Michigan, Ann Arbor, MI; Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH; Princess Alexandra Hospital, University of Queensland School of Medicine, Brisbane, Australia; National University of Ireland Galway, Galway, Ireland; GlycoMimetics, Rockville, MD; University of Washington/Fred Hutchinson Cancer Research Center, Seattle, WA GlycoMimetics, Inc.


 

 

 

 

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Overall Survival – R/R Patients RP2D analysis shown Median follow up is 6.6 months Censored at last known follow-up 16/66 (24%) have proceeded to HSCT 17 GlycoMimetics, Inc.


 

 

 

 

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Remission Duration – R/R Patients RP2D analysis shown Median follow up is 6.6 months Censored at last known follow-up 18 GlycoMimetics, Inc.


 

 

 

 

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Common Grade 3/4 Adverse Events – R/R Patients Adverse Event Type Phase 1 N=19 Phase 2 N=47 Total N=66 RP2D N=54 Cardiac 1 (5) 5 (11) 6 (9) 5 (9) Colitis 2 (11) 0 2 (3) 1 (2) GI 4 (21) 3 (6) 7 (11) 4 (7) Hepatic 0 3 (6) 3 (5) 3 (6) Infectious 16 (84) 34 (72) 50 (76) 39 (72) Bacteraemia 2 (11) 6 (13) 8 (12) 8 (15) Febrile neutropenia 6 (32) 25 (53) 31 (47) 27 (50) Sepsis 6 (32) 6 (13) 12 (18) 8 (15) Oral Mucositis Events Grades 1/2, n (%) 5 (26) 9 (19) 14 (21) 9 (17) Grades 3/4, n (%) 1 (5) 1 (2) 2 (3) 1 (2) *AE grade definitions follow CTCAE v4.03. 19 GlycoMimetics, Inc.


 

 

 

 

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GMI-1271: Phase 3 Study Design Targets ‘Gold Standard’ Approval Primary endpoint: Overall Survival Best opportunity to capture constellation of benefits seen in Phase 2 Positioned for submissions in US and Europe Strong potential label for launch and reimbursement Target enrollment of 380 patients ~30-40 sites in North America, Europe and Australia Planning mid-2018 trial start Target 4Q2020 topline readout 20 Strong positioning for most meaningful potential readout GlycoMimetics, Inc.


 

 

 

 

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GMI-1271 Relapsed / Refractory AML Phase 3 Study Design 21 Key Eligibility Criteria ≥18 and ≤75 years in age Either primary refractory or relapsed (first or second relapse) AML Eligible for intensive salvage treatment <1 prior HSCT MEC or FAI (n=190) HiDAC/IDAC GMI-1271 plus MEC or FAI (n=190) GMI-1271 plus HiDAC/IDAC 1:1 Randomization Induction (1 Cycle) Consolidation (Up to 3 Cycles) Follow-Up MEC: Mitoxantrone, etoposide and cytarabine FAI: Fludarabine, cytarabine and idarubicin HiDAC/IDAC: High-dose or Intermediate-dose cytarabine Randomization GlycoMimetics, Inc.


 

 

 

 

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GMI-1271 Comprehensive Development Approach in AML Strategic Collaborations with Leading Hematology / Oncology Cooperative Groups in the USA & EU to Enhance Utility of GMI-1271 Collaboration Announced Feb 8th 22 Collaboration Announced May 30th NCI-Sponsored Trial: Newly Diagnosed AML “Fit” for Chemo HOVON-Sponsored Trial: Newly Diagnosed AML “Unfit” for Chemo GMI-Sponsored Trial: R/R AML GlycoMimetics, Inc.

 


 

 

 

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Expanding Clinical Experience with GMI-1271 in AML 23 Phase 1 N=19 Phase 2 N=47 GMI-Sponsored Phase 3 N=380 R/R AML Phase 2 N=25 Newly Dx AML “Fit” NCI-Sponsored Phase 3 N= ~250 (Interim Analysis) Newly Dx AML “Unfit” HOVON-Sponsored Phase 2 N= ~140 Concurrent / Planned Clinical Trials Completed Clinical Trials Significant dataset with GMI-1271 across AML indications GlycoMimetics, Inc.


 

 

 

 

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GMI-1359 Clinical Program Underway Targeting Immune Modulation in Cancer 24 GlycoMimetics, Inc.


 

 

 

 

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GMI-1359 Enhancing Immune Response in Solid Tumors 25 Small molecule, dual inhibitor against E-selectin and CXCR4 Unique mechanism of action supports use in combination with chemotherapy and/or checkpoint inhibitors. In preclinical studies: Mobilizes tumor cells to sensitize them to effects of chemotherapy –e.g. inhibits progression of established bone metastases Alters tumor microenvironment to enhance immune response – e.g. reduction in tumor desmoplasia, reduction of intra-tumor regulatory T-cells Augments anti-tumor T-cell activity – e.g. robust mobilization of tumor-reactive Marrow Infiltrating Lymphocytes (MILs) Robust preclinical package in solid tumors (breast, prostate, pancreatic, osteosarcoma) and hematologic malignancies (FLT3 ITD AML, MM) Phase 1 in healthy volunteers ongoing Details regarding clinical trial program to be announced in Q4 2018 GlycoMimetics, Inc.


 

 

 

 

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Positioned for Success Pipeline, Progress, Catalysts 26 GlycoMimetics, Inc.


 

 

 

 

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A Portfolio of Exciting Product Candidates Compound Therapeutic Area Discovery Pre-Clinical Ph 1 Ph 2 Ph 3 Registration Partner Selectins Rivipansel (Pan-selectin Inhibitor) Sickle Cell Anemia Vaso-occlusive Crisis Pfizer GMI-1271 and Follow-ons (E-selectin Inhibitor) Acute Myelogenous Leukemia -- Multiple Myeloma -- Various Tumor Types & Inflammatory Diseases -- GMI-1359 (E-selectin & CXCR4 Inhibitor) Various Tumor Types -- Galectins Galectin-3 Inhibitor Fibrosis & Oncology -- Undisclosed Galectin Inhibitor Various Tumor Types – 27 GlycoMimetics, Inc.


 

 

 

 

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Clinical Progress Driving Value Creation Rivipansel (Phase 3) Phase 2 data selected as “Best of ASH” Orphan Drug Designation & Fast Track Status (US) Special Protocol Assessment with FDA Phase 3 study underway; enrollment completion 1Q 2019 2019 GMI-1271 (Phase 3 to begin 2018) Orphan Drug Designation (US & EU) & Fast Track Status (US) Completion of Phase 2 enrollment in two populations Breakthrough Therapy Designation granted by the FDA Presentation of Phase 1/2 results at ASCO, EHA and ASH Phase 1 POC study underway in multiple myeloma Registration program in AML to initiate 2018 2018 GMI-1359 (Phase 1) Presentation of preclinical data at AACR, SITC and ASH Phase 1 study underway 28 GlycoMimetics, Inc.


 

 

 

 

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Data Flow of Major Anticipated Announcements Q3 2018 GMI-1271 (Uproleselan): Initiation of GMI-sponsored Phase 3 registration trial in R/R AML Q1 2019 GMI-1271(Uproleselan): Initiation of NCI and HOVON consortium-funded AML trials in frontline populations Rivipansel enrollment completion 2019 Rivipansel top line data GMI-1271(Uproleselan): Proof-of-concept M-protein data in multiple myeloma 2020 Rivipansel: First commercial sale if P3 is positive (GMI estimate) GMI-1271(Uproleselan): Top line mOS data Phase 3 R/R AML trial 29


 

 

 

 

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Investment Opportunity – Nasdaq GLYC 30 Rivipansel: Only “on-demand” treatment in Phase 3 trial for acute VOC, enrollment to complete by end of Q1 2019 GMI-1271: Breakthrough Therapy Designation granted by the FDA, registration program initiating 2018 GMI-1359: Simultaneous blockade of CXCR4 & E-Selectin targets enhancing anti tumor immune response Advancing Pipeline Rivipansel: ~100,000 patients in USA, Pfizer considers “Potential Blockbuster” GMI-1271: > 44,000 AML patients in 7 major markets Significant Revenue Opportunities Top-tier biotech investors Cash balance of $240 million as of March 31, 2018 Strong Investment Base Pioneers in the field of glycobiology and small-molecule, therapeutic “mimetics” Relationships with leading KOLs and oncology networks Experienced Team GlycoMimetics, Inc.


 

 

 

 

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Innovation Today, Healing Tomorrow. July 2018 CORPORATE OVERVIEW NASDAQ: GLYC