GLYCOMIMETICS INC (GLYC) SPO
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|Company Name||GLYCOMIMETICS INC|
|Company Address||9708 MEDICAL CENTER DRIVE
ROCKVILLE, MD 20850
|CEO||Rachel K. King|
|Employees (as of 12/31/2017)||40|
|State of Inc||DE|
|Fiscal Year End||12/31|
|Shares Over Alloted||0|
|Shareholder Shares Offered||--|
|Lockup Period (days)||180|
|Quiet Period Expiration||4/30/2018|
We estimate that the net proceeds to us from our issuance and sale of shares of our common stock in this offering will be approximately $75.0 million, or approximately $86.2 million if the underwriters exercise in full their option to purchase up to 675,000 additional shares of common stock, after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us. Assuming the issuance of 4,500,000 shares of our common stock in this offering, a $1.00 increase (decrease) in the assumed public offering price of $17.79 per share, which was the last reported sale price of our common stock on the Nasdaq Global Market on March 16, 2018, would increase (decrease) our net proceeds from this offering by $4.2 million. We may also increase or decrease the number of shares being offered by us. An increase (decrease) of 1,000,000 shares in the number of shares offered by us would increase (decrease) our net proceeds from this offering by $16.7 million, assuming a public offering price of $17.79 per share, which was the last reported sales price of our common stock on the Nasdaq Global Market on March 16, 2018. Based on the planned use of proceeds described above, we believe that the net proceeds from this offering and our current cash, cash equivalents and marketable securities will be sufficient to enable us to fund our operating expenses and capital expenditure requirements into the first half of 2021. We have based this estimate on assumptions that may prove to be incorrect, and we could use our available capital resources sooner than we currently expect. We intend to use the net proceeds from this offering to conduct and complete our planned Phase 3 clinical development program for GMI-1271 in AML patients and to fund the research and development of our other clinical-stage and preclinical product candidates, including drug discovery, and for working capital and other general corporate purposes. This expected use of our net proceeds from this offering represents our intentions based upon our current plans and business conditions, which could change in the future as our plans and business conditions evolve. The amounts and timing of our actual expenditures may vary significantly depending on numerous factors, including the progress of our drug candidate development, the status of and results from clinical trials, as well as any collaborations that we may enter into with third parties for our drug candidates, and any unforeseen cash needs. As a result, our management will retain broad discretion over the allocation of the net proceeds from this offering, and investors will be relying on the judgment of our management regarding the application of the net proceeds from this offering. The timing and amount of our actual expenditures will be based on many factors, including cash flows from operations and the anticipated growth of our business. Pending these uses, we plan to invest these net proceeds in short-term, interest bearing obligations, investment-grade instruments, certificates of deposit or direct or guaranteed obligations of the United States. The goal with respect to the investment of these net proceeds is capital preservation and liquidity so that such funds are readily available to fund our operations.
The biotechnology and pharmaceutical industries are characterized by rapidly advancing technologies, intense competition and a strong emphasis on proprietary drugs. While we believe that our knowledge, experience and scientific resources provide us with competitive advantages, we face potential competition from many different sources, including major pharmaceutical, specialty pharmaceutical and biotechnology companies, academic institutions and governmental agencies and public and private research institutions. Any drug candidates that we successfully develop and commercialize will compete with existing therapies and new therapies that may become available in the future. The key competitive factors affecting the success of all of our drug candidates, if approved, are likely to be their safety, efficacy, convenience, price, the level of generic competition and the availability of coverage and reimbursement from government and other third-party payors. Rivipansel: Sickle Cell Disease Hydroxyurea and Endari are approved as prophylactic therapies for SCD. Based on publicly available information, we are not aware of any drugs currently approved in the United States as “on-demand” (as needed) for the treatment of SCD patients experiencing an acute VOC episode. There are a number of compounds that are in Phase 2 or Phase 3 clinical development as either prophylactic or gene therapy/blood transfusion approaches to treat patients with SCD, including: · Prophylactic Approaches: Novartis Pharmaceuticals Corporation (crizanlizumab, formerly SelG1); Baxter International (Aes-103); and Global Blood Therapeutics (voxelotor, formerly GBT440); and · Gene Therapy/Blood Transfusion Approaches: Blue Bird Bio (Lentiglobin BB305); Sangamo Biosciences/Bioverativ (ZFN Knockout); and Bellicum Pharmaceuticals (BPX-501). Attempts to develop a cure for SCD through gene therapy remain at an early stage of development, with significant variability observed to date in achieving target levels of anti-sickling hemoglobin. Should one or more of these prophylactic agents or gene therapy approaches be commercialized prior to rivipansel, they could reduce the number of VOC episodes each year, reducing the market opportunity for rivipansel. GMI-1271: AML and MM Our drug discovery, development and commercialization activities in oncology face, and will continue to face, intense competition from organizations such as pharmaceutical and biotechnology companies, as well as academic and research institutions and government agencies. As the treatment landscape for AML and MM changes, there is substantial risk that GMI-1271 might not provide additional benefit over other therapies. The following four new therapies were approved by the FDA for the treatment of AML in 2017: · RYDAPT® (midostaurin), an oral prescription medicine commercialized by Novartis to be used in combination with certain chemotherapy medicines to treat adults with newly diagnosed AML who have a defect in a gene called FLT3; · IDHIFA® (enasidenib), a prescription medicine commercialized by Celgene intended to treat people with AML with an isocitrate dehydrogenase-2 (IDH2) mutation whose disease has come back or has not improved after previous treatments; · VYXEOSTM (daunorubicin and cytarabine), commercialized by Jazz Pharmaceuticals, which is indicated for the treatment of adults with newly-diagnosed therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC); and · Mylotarg (gemtuzumab ozogamicin), commercialized by Pfizer, which is indicated for the treatment for the treatment of newly-diagnosed CD33-positive AML in adults (in combination with daunorubicin and cytarabine) and for treatment of relapsed or refractory CD33-positive AML in adults and in pediatric patients 2 years and older as a stand-alone treatment. While many chemotherapies in development for hematologic malignancies will likely be complementary to GMI-1271, there are also therapies in development that could be directly competitive with GMI-1271. In particular, there are a number of CXCR4 antagonists in clinical development that target the bone marrow microenvironment in order to mobilize and sensitize cancer cells to chemotherapy, including candidates developed by Sanofi-Aventis (Mozobil), Bristol Myers Squibb (BMS-936564), NOXXON Pharma (NOX-A12), Eli Lilly (LY2510924) and BioLine RX (BL-8040). Many of the companies against which we are competing, or against which we may compete in the future, have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals and marketing approved drugs than we do. Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources being concentrated among a smaller number of our competitors. Smaller or early stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These competitors also compete with us in recruiting and retaining qualified scientific and management personnel and establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs.
We are a clinical stage biotechnology company focused on the discovery and development of novel glycomimetic drugs to address unmet medical needs resulting from diseases in which carbohydrate biology plays a key role. Glycomimetics are molecules that mimic the structure of carbohydrates involved in
important biological processes. Using our expertise in carbohydrate chemistry and knowledge of carbohydrate biology, we are developing a pipeline of proprietary glycomimetics designed to inhibit disease-related functions of carbohydrates, such as the roles they play in inflammation, cancer and infection. We believe this represents an innovative approach to drug discovery to treat a wide range of diseases. We are focusing our initial efforts on drug candidates for rare diseases that we believe will qualify for orphan drug designation. Our first drug candidate, rivipansel, is being developed for the treatment of vaso-occlusive crisis, or VOC, a debilitating and painful condition that occurs periodically throughout the life of a person with sickle cell disease, or SCD. We have entered into a collaboration with Pfizer Inc., or Pfizer, for the further development and potential commercialization of rivipansel worldwide. Rivipansel has received fast track designation from the U.S. Food and Drug Administration, or FDA, as well as orphan drug designation from the FDA in the United States and from the European Medicines Agency, or EMA, in the European Union, or EU. We believe the clinical progress of rivipansel provides evidence of the significant potential of our lead program and our proprietary glycomimetics platform. Building on our experience with rivipansel, we are developing our second most advanced drug candidate, GMI-1271, to be used in combination with chemotherapy to treat either acute myeloid leukemia, or AML, or multiple myeloma, or MM, both of which are life-threatening hematologic cancers, and potentially other hematologic cancers as well. We are also developing a third drug candidate, GMI-1359, which is being evaluated in an ongoing Phase 1 clinical trial in healthy volunteers. GMI-1271 received orphan drug designation from the FDA in May 2015 for the treatment of AML. In June 2016, GMI-1271 received fast track designation from the FDA for the treatment of adult patients with relapsed or refractory AML and elderly patients aged 60 years or older with AML. In May 2017, GMI-1271 received breakthrough therapy designation from the FDA for the treatment of adult patients with relapsed or refractory AML. In May 2017, the European Commission, based on a favorable recommendation from the EMA Committee for Orphan Medicinal Products, granted orphan designation for GMI-1271 for the treatment of AML. We have retained the worldwide development and commercialization rights to all of our drug candidates other than rivipansel. Our intellectual property portfolio includes ownership of, or exclusive rights to, issued patents and pending patent applications claiming fundamental features of glycomimetic therapeutics, as well as those claiming methods of use for and chemical modifications of our drug candidates. Given the importance of our intellectual property portfolio to our business operations, we intend to vigorously enforce our rights and defend against challenges that have arisen or may arise in this area. Our issued patents directed to rivipansel and methods of use are expected to expire between 2023 and 2030. We also have issued patents which cover GMI-1271 and methods of use that expected to expire between 2032 and 2033. In addition, we have several pending patent applications covering GMI-1271 and/or methods of using it, the last expiring of which, if issued, currently would be predicted to expire in 2037. --- We were incorporated under the laws of the State of Delaware in April 2003 and commenced operations in May 2003. Our principal executive offices are located at 9708 Medical Center Drive, Rockville, Maryland 20850 and our telephone number is (240) 243-1201. Our website address is www.glycomimetics.com.
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