HISTOGENICS AND FDA TO CONTINUE DISCUSSIONS ON NEOCART PHASE 3

HISTOGENICS AND FDA TO CONTINUE DISCUSSIONS ON NEOCART PHASE 3

CLINICAL TRIAL DATA AND POTENTIAL REGULATORY PATHWAY

WALTHAM, Mass., November 1, 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 provided an update on the NeoCart regulatory pathway based on preliminary feedback from the Type C meeting held with the U.S. Food and Drug

Administration (the FDA) on October 30, 2018. At the meeting, the top-line results from the NeoCart Phase 3 clinical trial and the potential for the submission of a Biologics License Application (BLA)

were discussed. Following the meeting, the FDA and Histogenics continue to discuss the clinical data generated to date, the potential need for any additional supplemental clinical data (which may include longer-term data from the ongoing Phase 3

trial or additional studies) and potential alternative regulatory pathways for the BLA to be accepted. The FDA has not made a final decision regarding a potential BLA submission and based on expected feedback from the FDA, Histogenics intends to

provide a further update on these negotiations by the end of November 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 visit

www.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 ongoing discussions with the FDA regarding the potential submission of a BLA 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 partners expect to

compete; updated or refined data based on Histogenics continuing review and quality control

analysis of clinical data; the scope, progress, timing, expansion, and costs of developing and commercializing Histogenics product candidates; the ability to obtain and maintain regulatory

approval regarding the comparability of critical NeoCart raw materials following its technology transfer and manufacturing location transition; Histogenics expectations regarding its expenses and revenue; Histogenics ability to obtain

additional debt or equity capital; and other factors that are described in the Risk Factors and Management s Discussion and Analysis of Financial Condition and Results of Operations sections of Histogenics Annual

Report on Form 10-K for the year ended December 31, 2017 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2018, which are on file with the SEC

and available on the SEC s website at www.sec.gov. Additional factors may be set forth in those sections of Histogenics Form 10-Q for the quarter ended September 30, 2018, expected to be filed

with the SEC in the fourth quarter of 2018. In addition to the risks described above and in Histogenics Annual Report on Form 10-K and Quarterly Reports on Form

10-Q, Current Reports on Form 8-K and other filings with the SEC, other unknown or unpredictable factors also could affect Histogenics results. Histogenics has not

yet received the official FDA meeting minutes from the Type C meeting and the information in this Press Release may be altered or supplemented by the information contained in the official meeting minutes or any subsequent meetings that may be held

There can be no assurance that the actual results or developments anticipated by Histogenics will be realized or, even if substantially

realized, that they will have the expected consequences to, or effects on, Histogenics. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.

All written and verbal forward-looking statements attributable to Histogenics or any person acting on its behalf are expressly qualified in their entirety by

the cautionary statements contained or referred to herein. Histogenics cautions investors not to rely too heavily on the forward-looking statements Histogenics makes or that are made on its behalf. The information in this release is provided only as

of the date of this release, and Histogenics undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.