Cash Position: Cash and cash equivalents totaled $34.6 million at December 31, 2018, compared to $88.1 million at December 31, 2017. The decrease was due to repayment of debt and to increased funding of operations, which mainly consisted of research and development activities and general and administrative expenses offset by proceeds from exercise of stock options.
Operating Expenses: Research and development (R&D) expenses decreased to $16.1 million in the year ended December 31, 2018 from $34.3 million for the same period in 2017. The decrease was primarily attributable to a decrease in external expenses for the clinical studies and R&D internal department costs resulting from the previously announced discontinuance of the clinical studies and reduction in force. General and administrative (G&A) expenses decreased to $14.3 million in the year ended December 31, 2018 from $17.7 million for the same period in 2017. The decrease was due primarily to decreases in personnel costs, facilities, travel, marketing, legal and professional fees. Operating expenses for the year ended December 31, 2018 included restructuring expenses of $9.9 million related to the previously announced discontinuance of the NEWTON 2 study, and an equipment impairment charge of $2.8 million.
Net Loss: Net loss for the full-year 2018 was $40.9 million, or $1.31 per share, including the restructuring and impairment charges. Net loss for the full-year 2017 was $50.9 million, or $1.67 per share.
Pending Merger with PDS Biotechnology
In November 2018, Edge and PDS Biotechnology Corporation, a privately-held, clinical-stage cancer immunotherapy company, announced that their respective boards of directors had approved a definitive merger agreement. The merger is expected to create a combined company with a growing pipeline of next generation cancer immunotherapies based on the proprietary, multi-functional Versamune® technology platform. The merger is expected to close in the first quarter of 2019, subject to the approval of the stockholders of Edge, as well as other customary closing conditions.
Edge has scheduled a special stockholders meeting on March 14, 2019 for Edge stockholders to vote on the merger and related matters. For details on the proposed merger and the other matters to be considered at the special stockholder meeting, please see the Registration Statement on Form S-4 that was filed with the Securities Exchange Commission (SEC) on January 25, 2019.
Dismissal of Class Action Civil Litigation
On April 23, 2018, a purported securities class action complaint was filed against Edge, Brian Leuthner (Edge’s President and Chief Executive Officer) and Andrew Saik (Edge’s Chief Financial Officer) in the United States District Court for the District of New Jersey, captioned Sanfilippo v. Edge Therapeutics, Inc., Case No. 2:18-cv-8236. On December 7, 2018, the court appointed lead plaintiffs for the putative class and appointed a law firm as lead counsel for the putative class. On February 14, 2019, lead plaintiffs voluntarily dismissed the action, without prejudice, as to all defendants.
About Edge Therapeutics, Inc.
Edge Therapeutics, Inc. is a clinical-stage biotechnology company that seeks to discover, develop and commercialize novel therapies capable of transforming treatment paradigms for the management of serious medical conditions. For additional information about Edge, please visit www.edgetherapeutics.com.
This press release and any statements of representatives of Edge Therapeutics, Inc. related thereto that are not historical in nature 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," “seeks,” "intends," "plans," "potential" or similar expressions. 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.
Additional Information about the Merger and Where to Find It
This communication shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.
Participants in the Solicitation
Edge and PDS Biotechnology Corporation and their respective directors and executive officers and certain of their other members of management and employees may be deemed to be participants in the solicitation of proxies from the stockholders of Edge in connection with the proposed transaction. Information regarding the special interests of these directors and executive officers in the merger will be included in the proxy statement/prospectus referred to above. Additional information regarding the directors and executive officers of Edge is also included in Edge Annual Report on Form 10-K for the year ended December 31, 2018, filed with the SEC on the date hereof. These documents are available free of charge from the sources indicated above.
EDGE THERAPEUTICS, INC.
Statements of Operations and Comprehensive Loss
|Year Ended December 31,|
|Research and development expenses||$||16,068,769||$||34,311,650|
|General and administrative expenses||14,291,008||17,654,970|
|Total operating expenses||43,096,567||51,966,620|
|Loss from operations||(43,096,567)||(51,966,620)|
|Other income (expense):|
|Loss before income taxes||(43,649,943)||(53,445,860)|
|Benefit for income taxes||2,781,937||2,586,057|
|Net loss and comprehensive loss||$||(40,868,006)||$||(50,859,803)|
|Loss per share attributable to common stockholders basic and diluted||$||(1.31)||$||(1.67)|
|Weighted average common shares outstanding basic and diluted||31,242,176||30,393,952|
EDGE THERAPEUTICS, INC.
|Cash and cash equivalents||$||34,645,549||$||8,067,647|
|Prepaid expenses and other current assets||1,005,589||986,680|
|Total current assets||35,651,138||89,054,327|
|Property and equipment, net||26,952||3,423,880|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Short term debt||–||3,075,421|
|Total current liabilities||6,381,752||12,866,759|
|Long term debt||–||17,382,907|
|Preferred stock, 5,000,000 shares authorized at December 31, 2018 and 2017, zero outstanding||–||–|
|Common stock, $0.00033 par value, 75,000,000 shares authorized at December 31, 2018 and December 31, 2017,31,449,989 shares and 30,869,205 shares issued and outstanding at December 31, 2018 and December 31, 2017, respectively||10,591||10,400|
|Additional paid-in capital||222,644,982||214,309,370|
|Total stockholders' equity||29,839,208||62,371,411|
|Total liabilities and stockholders' equity||$||36,220,960||$||92,621,077|
Edge Therapeutics, Inc.