MELINTA THERAPEUTICS, INC. /NEW/ (MLNT) SPO
The SPO profiles may contain historical records.
Please visit the latest SPOs for the most recent information.
Please visit the latest SPOs for the most recent information.
|Company Name||MELINTA THERAPEUTICS, INC. /NEW/|
|Company Address||300 GEORGE STREET
NEW HAVEN, CT 06511
|Company Phone||312 767 0291|
|CEO||Daniel Mark Wechsler|
|Employees (as of 3/2/2018)||300|
|State of Inc||DE|
|Fiscal Year End||12/31|
|Shares Over Alloted||0|
|Shareholder Shares Offered||--|
|Lockup Period (days)||180|
|Quiet Period Expiration||7/4/2018|
We estimate that our net proceeds from the sale of shares of common stock in this offering will be approximately $102.4 million, after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us, but without giving effect to any reimbursement of certain of our expenses by the underwriters. If the underwriters exercise their option pursuant to this offering to purchase additional shares of our common stock in full, we estimate that our net proceeds will be approximately $114.8 million, after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us, but without giving effect to any reimbursement of certain of our expenses by the underwriters. We anticipate that we will use the net proceeds of this offering for general corporate purposes, including to invest in our industry leading portfolio of antibiotics, including potential expansion of our field sales force to drive growth; invest in our supply chain to optimize manufacturing processes and improve cost of goods; fund future milestone obligations primarily related to receipt of approval of Vabomere for European commercialization and payments to Medicines as part of the IDB Acquisition; capitalize on potential business development opportunities; and fund working capital. Pending these uses, we may invest the net proceeds in short-term, interest-bearing investment grade securities, certificates of deposit or direct or guaranteed obligations of the U.S. government. We have not determined the amount of net proceeds to be used specifically for such purposes. As a result, management will retain broad discretion over the allocation of net proceeds.
Our industry is highly competitive and subject to rapid and significant technological change. Our potential competitors include large pharmaceutical and biotechnology companies, specialty pharmaceutical and generic drug companies, academic institutions, government agencies and research institutions. In many cases, however, we believe that competition often will be determined by antibiotic class and any limitations of that antibiotic class in general, and the antibiotic specifically, in treating a particular disease or population. We believe that the key competitive factors that will affect the development and commercial success of product candidates that we develop or acquire are efficacy, safety and tolerability profile, convenience in dosing, price and reimbursement.
We are a commercial-stage pharmaceutical company focused on discovering, developing and commercializing differentiated anti-infectives for the hospital and select non-hospital, or community, settings that address the need for effective treatments for infections due to resistant gram-negative
and gram-positive bacteria. We have a deep pipeline of commercial, clinical and preclinical antibiotic assets across multiple approved and potential indications, and our marketed products are expected to deliver a distinct value proposition across the antibiotic care continuum. We have a platform for long-term, durable growth and a strategy to expand the anti-infective portfolio over time, providing the opportunity for multiple layers of revenue growth. We began 2018 as a newly transformed company, with two major product launches underway with two separate field forces supporting the launches. Going into the IDB Transaction, Melinta had 50 sales representatives preparing to launch Baxdela and the Medicines Company had 85 representatives launching Vabomere and selling Orbactiv and Minocin. We made a conscious decision to not disrupt these launches. Each team also had its own unique and distinct incentive plan. As of May 2018, we have integrated the sales representatives into one sales team with one common incentive plan, designed to maximize our business across our entire portfolio. This new structure matches the business locally and allows for flexibility as opportunities occur in both the inpatient or the outpatient setting. Our new sales team was designed with four goals. First, maximize the launches of Vabomere and Baxdela, while maintaining the growth Orbactiv and Minocin. Second, limit business and customer disruptions while bolstering our talent. Third, create flexibility for potential future asset acquisitions. And fourth, capture and capitalize on existing long-term customer relationships, which is critically important in the hospital setting. Baxdela (delafloxacin) Baxdela is a commercial-stage asset that offers a new option for monotherapy treatment of adult patients with acute bacterial skin or skin structure infections (“ABSSSI”) in oral and intravenous (“IV”) formulations. Baxdela is a novel fluoroquinolone that exhibits activity against both gram-positive and gram-negative pathogens, is unique among quinolones in that it is effective against methicillin-resistant staphylococcus “aureus” (“MRSA”), and is available to initiate therapy on either the IV or oral formulation. In clinical trials, Baxdela was well tolerated; the most common adverse events (“AEs”) were mild gastrointestinal complaints. On June 19, 2017, the Food and Drug Administration (“FDA”) approved the use of Baxdela as a treatment of adult patients with ABSSSI. The commercial launch of Baxdela for the adult patient treatment of ABSSSI occurred in the first quarter of 2018. The FDA also confirmed Baxdela’s status as a Qualified Infectious Disease Product (“QIDP”) under the provisions of the 2012 Generating Antibiotics Incentives Now Act (the “GAIN Act”), and extended by five years the five-year exclusivity granted to Baxdela as a new chemical entity (“NCE”), for a total of ten years in the United States. Consequently, and because we believe Baxdela has utility across many different infection types, we have commenced Phase 3 clinical development for community acquired bacterial pneumonia (“CABP”) and may pursue additional indications for Baxdela in the future. Baxdela has the potential to address a variety of bacterial infections in the United States. In addition, we have partnered with leading multinational pharmaceutical firms for distribution of Baxdela in markets outside the United States, including with Menarini IFR SrL for Europe and Asia-Pacific (excluding Japan) and with Eurofarma Laboratórios S.A. for Central and South America. We may obtain additional funds through the achievement of regulatory, commercial and sales-based milestones, as well as royalties on sales of Baxdela outside the United States. Vabomere (meropenem and vaborbactam) Vabomere is the combination of meropenem, the leading carbapenem used in the treatment of gram-negative infections, and vaborbactam, a novel beta-lactamase inhibitor that inhibits certain types of resistance mechanisms used by bacteria. Vabomere received FDA approval on August 29, 2017, for the treatment of patients 18 years of age and older with complicated urinary tract infections (“cUTI”), including pyelonephritis, caused by designated susceptible Enterobacteriaceae and became commercially available in the fourth quarter of 2017. Vabomere was specifically developed to address gram-negative bacteria that produce beta-lactamase enzymes, particularly the Klebsiella pneumoniae carbapenemase (“KPC”) enzyme. KPC-producing bacteria are responsible for a large majority of carbapenem-resistant Enterobacteriaceae (“CRE”) in the United States and are classified by the U.S. Centers for Disease Control (“CDC”) and the World Health Organization (“WHO”) to be an urgent antimicrobial resistance threat. With its approval, the FDA also confirmed that Vabomere is eligible for the five-year GAIN Act extension of exclusivity under the provisions of the GAIN Act, though the question of whether Vabomere would be eligible for a five-year NCE exclusivity or three-year exclusivity was referred to the Exclusivity Board of the Center for Drug Evaluation and Research (“CDER”). The new drug application (“NDA”) for Vabomere was based upon the TANGO-1 study, which evaluated the efficacy and safety of Vabomere versus piperacillin/tazobactam in cUTI and acute pyelonephritis due to susceptible Enterobacteriaceae. In the TANGO-1 study, 98.4% of patients on the Vabomere arm met the primary endpoint of clinical success at the end of IV treatment, compared to 94.0% of patients in the piperacillin/tazobactam arm. Patients in the Vabomere arm of the study had fewer discontinuations due to adverse events (“AEs”) as compared to the piperacillin/tazobactam arm (2.9% vs. 5.1%), and the type of AEs seen in the trial were similar to that of meropenem alone. On July 25, 2017, Medicines announced positive results from a planned interim analysis of the TANGO-2 trial, a multi-center, randomized, open-label Phase 3 trial. The TANGO-2 trial compared Vabomere to best available therapy (“BAT”) in the treatment of infections caused by CRE and is the only trial that evaluated a monotherapy option in treating infections caused by KPC mediated CRE. Randomization in the trial was stopped early, following a recommendation by the Drug Safety Monitoring Board (“DSMB”). The recommendation was based upon an interim analysis of 72 patients, including 43 with microbiologically evaluable CRE infections of blood, lung, urinary tract and abdominal organs. The DSMB concluded that the benefit-risk ratio no longer supported randomization of patients to the BAT arm due to results seen in patients in the Vabomere arm. The data showed a higher cure rate at test of cure and end of therapy as well as lower all-cause mortality versus BAT across all infection types. In addition, Vabomere had a lower rate of drug-related AEs versus BAT (24% vs. 44%). Vabomere is indicated for cUTI and we believe the profile represents a leading therapy for treatment of serious infections due to gram-negative bacteria, including KPC-mediated CRE, which is Vabomere’s focus. Orbactiv Orbactiv is a long-acting IV antibiotic of the lipoglycopeptide class that allows for single infusion for the treatment of adult patients with ABSSSIs caused or suspected to be caused by susceptible gram-positive bacteria, including MRSA with no dose adjustment for mild/moderate renal or hepatic impairment or for age, weight, gender, or race. It is the only antibiotic in this class that has three distinct mechanisms of action against the cell wall of the bacteria. It provides an alternative solution to hospital admission or multiple days of IV therapy in outpatient setting. In contrast to the current standard of care (6 to 10 days of IV therapy), single-dose ABSSSI therapy with Orbactiv alternative increases patient convenience, helps to ensure patient compliance with a single dose, and allows for treatment in alternative, lower cost care settings. Minocin for injection Minocin is an IV antibiotic of the tetracycline class with broad-spectrum activity against gram-positive and gram-negative pathogens. A new formulation was launched in 2015, which improved tolerability and convenience in administration, owing to a smaller required infusion volume. Minocin is one of the few agents approved for treatment of Acinetobacter spp. Acinetobacter infections are generally seen in the intensive care unit (“ICU”), particularly in mechanically ventilated and immunocompromised patients. --- Melinta Therapeutics, Inc. was incorporated in Delaware under the Delaware General Corporation Law on November 18, 2005. Our registered office is located at 3500 South Dupont Highway, in the City of Dover, Kent County, Delaware 19901 and our principal executive offices are located at 300 George Street, Suite 301, New Haven, Connecticut 06511. Our website address is www.melinta.com.
|Auditor||Deloitte & Touche LLP|
|Company Counsel||Willkie Farr & Gallagher LLP|
|Lead Underwriter||J.P. Morgan Securities LLC|
|Lead Underwriter||Jefferies LLC|
|Transfer Agent||Computershare Trust Company, N.A|
|Underwriter||Cantor Fitzgerald & Co.|
|Underwriter Counsel||Davis Polk & Wardwell LLP|
EDGAR® Online, a division of Donnelley Financial Solutions. EDGAR® is a federally registered trademark of the U.S. Securities and Exchange Commission. EDGAR Online is not affiliated with or approved by the U.S. Securities and Exchange Commission.