Exhibit 99.1
HISTOGENICS TO MEET WITH FDA TO DISCUSS NEOCART PHASE 3 CLINICAL TRIAL DATA AND POTENTIAL REGULATORY PATHWAY
WALTHAM, Mass., September 26, 2018 /GLOBE NEWSWIRE/ – Histogenics Corporation (Histogenics) (Nasdaq: HSGX), a leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function, today announced that the U.S. Food and Drug Administration (the FDA) has granted a Type C meeting on October 30, 2018 to discuss thetop-line results from the NeoCart Phase 3 clinical trial and Histogenics’ planned Biologics License Application submission. Histogenics submitted its briefing materials regarding thetop-line data of the NeoCart Phase 3 clinical trial to the FDA inmid-September 2018, and has been working closely with the FDA to schedule the meeting. Histogenics expects to provide an update following this meeting in early November 2018, with meeting minutes expected by late November 2018 or early December 2018. During the third quarter of 2018, Histogenics has sold an aggregate of 3,550,416 shares of common stock inat-the-market offerings pursuant to Histogenics’ equity distribution agreement with Canaccord Genuity Inc. for aggregate net proceeds of $2.72 million after deducting sales agent fees and expenses. Histogenics believes that its existing cash and cash equivalents will be sufficient to fund its projected cash needs late into the fourth quarter of 2018.
About Histogenics Corporation
Histogenics (Nasdaq: HSGX) is a leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function. Histogenics’ lead investigational product, NeoCart, is designed to rebuild a patient’s own knee cartilage to treat pain at the source and potentially prevent a patient’s progression to osteoarthritis. NeoCart is one of the most rigorously studied restorative cell therapies for orthopedic use. NeoCart is designed to perform like articular hyaline cartilage at the time of treatment, and as a result, may provide patients with more rapid pain relief and accelerated recovery as compared to the current standard of care. Histogenics’ technology platform has the potential to be used for a broad range of additional restorative cell therapy indications. For more information on Histogenics and NeoCart, please visitwww.histogenics.com.
Forward-Looking Statements
Various statements in this release 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 Histogenics’ forward-looking statements include, among others: expectations regarding the timing and success of discussions with the FDA regarding the submission of a biologics license application for NeoCart; NeoCart’s potential as a treatment for knee cartilage damage; the timing, associated expenses and ability to obtain and maintain regulatory approval of NeoCart or any product candidates, and the labeling for any approved products; the market size and potential patient population in markets where Histogenics’ and its
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