0001140361-16-074481.txt : 20160803 0001140361-16-074481.hdr.sgml : 20160803 20160803073017 ACCESSION NUMBER: 0001140361-16-074481 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20160803 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20160803 DATE AS OF CHANGE: 20160803 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Edge Therapeutics, Inc. CENTRAL INDEX KEY: 0001472091 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 264231384 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-37568 FILM NUMBER: 161802222 BUSINESS ADDRESS: STREET 1: 200 CONNELL DRIVE STREET 2: SUITE 1600 CITY: BERKELEY HEIGHTS STATE: NJ ZIP: 07922 BUSINESS PHONE: 800-208-3343 MAIL ADDRESS: STREET 1: 200 CONNELL DRIVE STREET 2: SUITE 1600 CITY: BERKELEY HEIGHTS STATE: NJ ZIP: 07922 8-K 1 form8k.htm EDGE THERAPEUTICS, INC 8-K 8-3-2016

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): August 3, 2016
_____________________________

Edge Therapeutics, Inc.
(Exact name of Registrant as specified in its charter)
_____________________________

Delaware
001-37568
26-4231384
(State or Other Jurisdiction
(Commission
(I.R.S. Employer
of Incorporation or Organization)
File Number)
Identification No.)

200 Connell Drive, Suite 1600
Berkeley Heights, NJ 07922 (800) 208-3343
(Address, Including Zip Code, and Telephone Number, Including Area Code, of Registrant’s Principal Executive Offices)

Not Applicable
(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 (17CFR 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))
 

 


Item 2.02 Results of Operations and Financial Condition

On August 3, 2016, Edge Therapeutics, Inc. issued a press release announcing its financial results for the three months ended June 30, 2016. A copy of that press release and the financial schedules attached thereto is furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K.

In accordance with General Instruction B.2 of Form 8-K, the information set forth in this Current Report on Form 8-K is deemed to be “furnished” and shall not be deemed to be “filed” for purposes of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). The information in this Item 2.02, as well as Exhibit 99.1, shall not be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act regardless of any general incorporation language in such filing.

Item 9.01. Financial Statements and Exhibits

Exhibit
 
Number
Description
   
99.1
Press release dated August 3, 2016 announcing financial results for the three months ended June 30, 2016.
 


SIGNATURE

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

Dated: August 3, 2016
Edge Therapeutics, Inc.
         
   
By:
/s/ Andrew J. Einhorn
     
Name:
Andrew J. Einhorn
     
Title:
Chief Financial Officer
 


Exhibit Index

Exhibit
 
Number
Description
   
Press release dated August 3, 2016 announcing financial results for the three months ended June 30, 2016.

 

EX-99.1 2 ex99_1.htm EXHIBIT 99.1

Exhibit 99.1
 
 
Edge Therapeutics Reports Second Quarter Financial Results and Recent Highlights

Initiates EG-1962 Phase 3 NEWTON 2 Study for Aneurysmal Subarachnoid Hemorrhage

Closes $20 Million Debt Facility with Hercules Capital, Inc.

BERKELEY HEIGHTS, N.J., August 3, 2016Edge 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 June 30, 2016 and recent highlights.

“Edge has made recent significant clinical and corporate progress on multiple fronts,” said Brian A. Leuthner, Edge’s President and Chief Executive Officer. “Our clinical progress is highlighted by the initiation of our Phase 3 NEWTON 2 study of EG-1962 in aneurysmal subarachnoid hemorrhage. On the financial side, we recently closed a $20 million debt facility, which increases our cash position and provides non-dilutive funding at an attractive cost of capital, enabling us to extend our cash runway in order to execute our growth strategy. We are also continuing to build out our management team with the necessary expertise, experience and leadership to help us advance our promising portfolio of life-saving therapies toward commercialization.”

Recent Highlights

· In May 2016, the U.S. Food and Drug Administration granted Fast Track designation to EG-1962 for the treatment of subarachnoid hemorrhage.
· In June 2016, the U.S. Patent and Trademark Office granted a new patent covering the use of EG-1962 administered intraventricularly for the treatment of a delayed complication of a brain injury affecting cerebral blood flow.
· In June 2016, Harry J. Sacks, M.D., FAAP, was appointed Vice President, Clinical Development, thus expanding the team directing the global strategy, planning and execution of Edge’s clinical studies.
· In July 2016, the first patient was treated in Edge’s pivotal Phase 3 NEWTON 2 (Nimodipine microparticles to Enhance recovery While reducing TOxicity after subarachNoid hemorrhage) clinical study comparing the efficacy and safety of EG-1962 to standard of care oral nimodipine in adults who suffer an aneurysmal subarachnoid hemorrhage (aSAH) resulting from a ruptured brain aneurysm.
· In August 2016, Edge closed a $20 million dual-tranche term loan with Hercules Capital, Inc. The term loan will be used to refinance existing debt and for general corporate purposes.

Financial Results

Cash Position: Cash, cash equivalents and marketable securities as of June 30, 2016 were $111.0 million, compared with $130.2 million as of December 31, 2015.
 
1


 
Research & Development (R&D) Expenses: R&D expenses were $6.0 million for the three months ended June 30, 2016, compared to $3.2 million in the same period in 2015. The increase in R&D expense was primarily due to increased spending on clinical activities, including preparations for the Phase 3 NEWTON 2 study, increased personnel-related costs and other R&D expenses.

General & Administrative (G&A) Expenses: General and administrative expenses were $3.3 million for the three months ended June 30, 2016, compared to $1.8 million in the same period in 2015. The increase in G&A expense was largely due to stock based compensation expenses, personnel-related costs, professional fees and additional expenses to support public company operations.

Net Loss: Net loss was $9.4 million for the three months ended June 30, 2016, compared to net loss of $5.5 million for the same period in 2015.

Conference Call Details

Edge will host a conference call and webcast today, Wednesday, August 3, 2016 at 8:30 a.m. Eastern time. Please dial (877) 388-5691, or (562) 350-0788 for international callers, and reference participant code 56303947 approximately 15 minutes prior to the call. A replay of the call may be accessed through August 17, 2016 on the investor section of Edge’s website or by dialing (855) 859-2056, or (404) 537-3406 for international callers, and referencing participant code 56303947. A live webcast of the conference call will be available on the investor relations section of Edge’s website at www.edgetherapeutics.com.

About Edge Therapeutics, Inc.
Edge Therapeutics, Inc. (Edge) is a clinical-stage biotechnology company that discovers, develops and seeks to commercialize novel, hospital-based therapies capable of transforming treatment paradigms for the management of acute, life-threatening neurological conditions. EG-1962, Edge’s lead product candidate, has the potential to fundamentally improve patient outcomes and transform the management of aneurysmal subarachnoid hemorrhage, or aSAH, which is bleeding around the brain due to a ruptured brain aneurysm. For additional information about Edge, please visit www.edgetherapeutics.com.

Forward-Looking Statements
This press release and any statements of representatives of Edge Therapeutics, Inc. related thereto that are not historical in nature (including but not limited to upcoming milestones) contain, or may contain, among other things, certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, without limitation, statements with respect to Edge’s plans, objectives, projections, expectations and intentions and other statements identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential" or similar expressions, including statements with respect to Edge’s ability to advance its portfolio of therapies towards commercialization. These statements are based upon the current beliefs and expectations of Edge’s management and are subject to significant risks and uncertainties. Actual results may differ significantly from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various risk factors (many of which are beyond Edge's control) as described under the heading "Risk Factors" in Edge’s filings with the United States Securities and Exchange Commission.
 
2


 
Investor Contact:
Gregory Gin
Edge Therapeutics, Inc.
Tel: 1-800-208-EDGE (3343)
Email: ir@edgetherapeutics.com

Media Contact:
Laura Bagby
6 Degrees
Tel: 312-448-8098
Email: lbagby@6degreespr.com
 
3


 
EDGE THERAPEUTICS, INC.
Statements of Operations and Comprehensive Loss

   
Three Months Ended June 30,
   
Six Months Ended June 30,
 
   
2016
   
2015
   
2016
   
2015
 
             
                         
Operating expenses:
                       
Research and development expenses
 
$
5,975,306
   
$
3,195,244
   
$
11,322,069
   
$
6,066,483
 
General and administrative expenses
   
3,288,889
     
1,765,065
     
6,974,486
     
3,076,095
 
                                 
Total operating expenses
   
9,264,195
     
4,960,309
     
18,296,555
     
9,142,578
 
                                 
Loss from operations
   
(9,264,195
)
   
(4,960,309
)
   
(18,296,555
)
   
(9,142,578
)
                                 
Other income (expense):
                               
Warrant remeasurement
   
-
     
(350,129
)
   
-
     
(446,321
)
Interest income
   
49,376
     
1,338
     
92,190
     
1,477
 
Interest expense
   
(161,310
)
   
(211,863
)
   
(342,174
)
   
(402,026
)
                                 
Net loss and comprehensive loss
   
(9,376,129
)
   
(5,520,963
)
   
(18,546,539
)
   
(9,989,448
)
                                 
Cumulative dividend on Series C , C-1 and C-2 convertible preferred stock
   
-
     
(1,746,334
)
   
-
     
(2,429,515
)
                                 
Net loss attributable to common stockholders
 
$
(9,376,129
)
 
$
(7,267,297
)
 
$
(18,546,539
)
 
$
(12,418,963
)
                                 
Loss per share attributable to common stockholders basic and diluted
 
$
(0.33
)
 
$
(4.30
)
 
$
(0.64
)
 
$
(7.36
)
                                 
Weighted average common shares outstanding basic and diluted
   
28,828,449
     
1,688,475
     
28,820,678
     
1,688,475
 
 
4


 
EDGE THERAPEUTICS, INC.
Balance Sheets

   
June 30,
   
December 31,
 
   
2016
   
2015
 
ASSETS
 
(unaudited)
       
Current assets:
           
Cash and cash equivalents
 
$
111,022,034
   
$
130,189,421
 
Prepaid expenses and other current assets
   
793,808
     
1,081,084
 
Total current assets
   
111,815,842
     
131,270,505
 
                 
Property and equipment, net
   
3,461,121
     
2,766,992
 
Other assets
   
142,870
     
55,161
 
                 
Total assets
 
$
115,419,833
   
$
134,092,658
 
                 
LIABILITIES AND STOCKHOLDERS' EQUITY
               
LIABILITIES
               
Current liabilities:
               
Accounts payable
 
$
2,854,796
   
$
2,584,249
 
Accrued expenses
   
1,519,909
     
3,734,348
 
Short term debt
   
2,389,222
     
2,271,111
 
Total current liabilities
   
6,763,927
     
8,589,708
 
                 
Noncurrent liability:
               
Long term debt
   
1,899,802
     
3,025,423
 
                 
                 
STOCKHOLDERS' EQUITY
               
Common stock, $0.00033 par value, 75,000,000 shares authorized at June 30, 2016 and December 31, 2015, 28,849,446 shares and 28,810,845 shares issued and outstanding at June 30, 2016 and December 31, 2015, respectively.
   
9,733
     
9,720
 
Additional paid-in capital
   
187,546,880
     
184,721,777
 
Accumulated deficit
   
(80,800,509
)
   
(62,253,970
)
Total stockholders' equity
   
106,756,104
     
122,477,527
 
                 
Total liabilities and stockholders' equity
 
$
115,419,833
   
$
134,092,658
 

 
5
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