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Histogenics Corporation Announces Second Quarter 2015 Financial and Operating Results
- Continued Progress on NeoCart® Phase 3 Trial and 2015 Business Objectives -
- Company to Host Conference Call and Webcast Today at
"The second quarter was one of transition as we hired several new executives to drive the further development and commercialization of NeoCart," stated
Second Quarter 2015 and Recent Highlights
Histogenicscontinued to enroll patients in the NeoCart Phase 3 trial with completion of enrollment targeted by the end of the second quarter of 2016. Several enrollment optimization initiatives in the second quarter were completed, with new investigators joining the trial, expanding eligibility to include Kaiser Permanentepatients in California, and the launch of targeted local recruiting campaigns to support the Phase 3 trial investigators.
Histogenicsand Intrexon Corporation( Intrexon), Histogenics'collaboration partner for potential next generation products, have completed the evaluation of multiple alternatives for development of an allogeneic, one-step treatment for cartilage repair. The partners have elected to pursue an induced pluripotent stem cells (iPSC) approach. The next technical milestone is the demonstration of the capability of an Intrexondeveloped iPSC-derived cell line in the NeoCart cell and tissue engineering manufacturing process in the first quarter of 2016.
Histogenicscompleted the near-term buildout of its management team with the hiring of Jon Lieberand Gloria Matthewsas Chief Financial Officer and Chief Medical Officer, respectively. Steve Kennedywas also promoted to Chief Technology Officer to round out the executive management team.
Histogenicshas renewed its focus on its intellectual property estate and product portfolio, and has recently completed several projects to prepare for potential partnerships or collaborations around its broad patent portfolio and historical product candidates, both in the cellular, tissue and biomaterials space of Histogenics'regenerative medicine platform.
June 2015 Histogenicsreceived a notice of allowance from the United States Patent and Trademark Office regarding a method of use for a double-structured tissue implant for treatment of tissue defects. The Company believes this further enhances the depth of protection around the NeoCart proprietary scaffolds.
Financial Results for the Second Quarter 2015
For the second quarter of 2015,
Conference Call and Webcast Information
Management will host a conference call on
A live audio webcast of the presentation will be available via the "Investor Relations" page of the
Various statements in this release, including, but not limited to, the guidance provided above, are "forward-looking statements" under the securities laws. Words such as, but not limited to, "anticipate," "believe," "can," "could," "expect," "estimate," "design," "goal," "intend," "may," "might," "objective," "plan," "predict," "project," "target," "likely," "should," "will," and "would," or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties.
Important factors that could cause actual results to differ materially from those reflected in the Company's forward-looking statements include, among others: the timing and success of
There can be no assurance that the actual results or developments anticipated by
All written and verbal forward-looking statements attributable to
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(in thousands, except share and per share data)|
|Three Months Ended June 30,||Six Months Ended June 30,|
|Research and development||$5,858||$4,669||$11,622||$8,043|
|General and administrative||1,735||1,341||3,844||3,140|
|Total operating expenses||7,593||6,010||15,466||11,183|
|Loss from operations||$ (7,593)||$ (6,010)||$ (15,466)||$ (11,183)|
|Other income (expense):|
|Interest expense, net||$ (26)||$ --||$ (88)||$ --|
|Other income (expense), net||(14)||(3)||(43)||(5)|
|Change in fair value of warrant liability, other liability and net sales distribution payment liability||--||(2,289)||--||(551)|
|Total other income (expense), net||(40)||(2,292)||(131)||(556)|
|Net loss||$ (7,633)||$ (8,302)||$ (15,597)||$ (11,739)|
|Loss attributable to common stockholders - basic and diluted||$ (7,633)||$ (11,822)||$ (15,597)||$ (15,259)|
|Loss per common share - basic and diluted:||$ (0.58)||$ (19.85)||$ (1.18)||$ (25.91)|
|Weighted-average shares used to compute earnings per common share - basic and diluted:||13,215,701||595,552||13,208,483||588,936|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|(in thousands, except share and per share data)|
|Cash and cash equivalents||$45,222||$58,060|
|Prepaid expenses and other current assets||897||796|
|Property and equipment, net||5,428||4,878|
|Other assets, net||1,691||1,765|
|Total stockholder's equity||43,865||54,206|
|Total liabilities and stockholders' equity||$53,238||$65,499|
CONTACT: Investor Relations Tel: +1 (781) 547-7909 InvestorRelations@histogenics.com