BERKELEY HEIGHTS, N.J., Nov. 01, 2016 (GLOBE NEWSWIRE) -- Edge Therapeutics, Inc. (Nasdaq:EDGE), a clinical-stage biotechnology company developing novel hospital-based therapies for the management of acute, life-threatening conditions, today announced financial results for the three months ended September 30, 2016 and recent highlights. "Our operations are progressing according to plan and we now have multiple sites actively screening patients for our Phase 3 NEWTON 2 study of EG-1962, including many leading academic centers that are high-volume treatment centers for aneurysmal subarachnoid hemorrhage (aSAH)," said Brian A. Leuthner, Edge's President and Chief Executive Officer. "During the quarter, we held investigator meetings for North American and Israeli sites participating in NEWTON 2, and received positive feedback and strong enthusiasm for the potential clinical benefit of EG-1962 over the current standard of care. In addition, we have commenced patient screening in our cisternal EG-1962 study and are on track for initiating patient enrollment in the fourth quarter of 2016. At the same time, we continue to bolster our management team by adding the necessary leadership and experience that complements the existing Edge team, and strengthens our position to advance our promising portfolio of life-saving therapies toward commercialization." Third Quarter and Recent Highlights
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- In July, Edge initiated the pivotal Phase 3 NEWTON 2 ( Nimodipine microparticles to Enhance recovery While reducing TOxicity after subarach Noid hemorrhage) study of EG-1962 administered through an existing external ventricular drain (EVD) in adults who suffer an aSAH resulting from a ruptured brain aneurysm. For information on NEWTON 2, including a list of study sites, please visit clinicaltrials.gov and enter the identifier NCT02790632.
- In August, Edge closed a $20 million dual-tranche term loan with Hercules Capital, Inc. At closing, $15 million was drawn down with an additional $5 million available to be drawn down at Edge's option until June 2017. Proceeds from the term loan refinanced existing debt and will be used for general corporate purposes.
- In September, Edge announced additional positive pharmacokinetic data from the Phase 1/2 NEWTON North American study of EG-1962 that supports the potential clinical and health economic impact of EG-1962 in aSAH.
- In October, Edge appointed Dan Brennan, a proven and respected commercial leader in the biopharmaceutical industry, to the newly created position of Chief Operating Officer.
- In the third quarter, Edge began screening patients in a multi-center, randomized, controlled, open-label study of intracisternal administration of EG-1962 in adults with aSAH. This study will investigate the safety and pharmacokinetic profile of EG-1962 administered directly into the basal cisterns of the brain compared to standard of care oral nimodipine in a group of 12 patients with aSAH. Clinical outcomes will be assessed, as well.
|Three Months Ended September 30,||Nine Months Ended September 30,|
|Research and development expenses||$||6,724,503||$||6,507,972||$||18,046,572||$||12,574,455|
|General and administrative expenses||3,552,289||1,976,888||10,526,775||5,052,983|
|Total operating expenses||10,276,792||8,484,860||28,573,347||17,627,438|
|Loss from operations||(10,276,792||)||(8,484,860||)||(28,573,347||)||(17,627,438||)|
|Other income (expense):|
|Net loss and comprehensive loss||(10,759,262||)||(10,130,050||)||(29,305,801||)||(20,119,498||)|
|Cumulative dividend on Series C , C-1 and C-2 convertible preferred stock||-||(1,827,568||)||-||(4,257,083||)|
|Net loss attributable to common stockholders||$||(10,759,262||)||$||(11,957,618||)||$||(29,305,801||)||$||(24,376,581||)|
|Loss per share attributable to common stockholders|
|basic and diluted||$||(0.37||)||$||(7.08||)||$||(1.02||)||$||(14.44||)|
|Weighted average common shares outstanding basic and diluted||28,896,941||1,688,475||28,848,842||1,688,475|
|September 30,||December 31,|
|Cash and cash equivalents||$||112,784,622||$||130,189,421|
|Prepaid expenses and other current assets||359,863||1,081,084|
|Total current assets||113,144,485||131,270,505|
|Property and equipment, net||3,291,873||2,766,992|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Short term debt||-||2,271,111|
|Total current liabilities||4,253,599||8,589,708|
|Long term debt||14,817,482||3,025,423|
|Common stock, $0.00033 par value, 75,000,000 shares authorized at September 30, 2016 and December 31, 2015, 28,915,226 shares and 28,810,845 shares issued and outstanding at September 30, 2016 and December 31, 2015, respectively||9,754||9,720|
|Additional paid-in capital||189,058,164||184,721,777|
|Total stockholders' equity||97,508,147||122,477,527|
|Total liabilities and stockholders' equity||$||116,579,228||$||134,092,658|
Investor Contact:Gregory GinEdge Therapeutics, Inc.Tel: 1-800-208-EDGE (3343)Email: email@example.comMedia Contact:Laura Bagby6 DegreesTel: 312-448-8098Email: firstname.lastname@example.org