HISTOGENICS CORPORATION (NASDAQ:HSGX) Files An 8-K Entry into a Material Definitive Agreement
Item 1.01. Entry into a Material Definitive Agreement.

Equity Distribution Agreement

On March15, 2018, Histogenics Corporation (“Histogenics”) entered into an equity distribution agreement (the “Equity Distribution Agreement”) with Canaccord Genuity Inc. (“Canaccord”), to which Histogenics may, from time to time, sell shares of Histogenics’ common stock, par value $0.01 per share (the “Shares”), having an aggregate offering price of up to $10million through Canaccord, as Histogenics’ sales agent.

The Shares will be offered and sold by Histogenics to its previously filed and currently effective Registration Statement on Form S-3 (Reg. No.333-216741) (the “Registration Statement”). The Shares may only be offered and sold by means of a prospectus, including a prospectus supplement, forming part of the effective Registration Statement. Sales of the common stock, if any, will be made at market prices by methods deemed to be an “at the market offering” as defined in Rule 415 promulgated under the Securities Act of 1933, as amended (the “Securities Act”), including sales made directly on The Nasdaq Capital Market, on any other existing trading market for the common stock, or to or through a market maker other than on an exchange. We will pay Canaccord a commission rate of 3.0% of the gross proceeds from the sales of common stock sold to the terms of the Equity Distribution Agreement. We also have provided Canaccord with customary indemnification rights. We and Canaccord each have the right, by giving written notice as specified in the Equity Distribution Agreement, to terminate the Equity Distribution Agreement in each party’s sole discretion at any time.

The Company is not obligated to make any sales of the Shares under the Equity Distribution Agreement. The offering of Shares to the Equity Distribution Agreement will terminate upon the earlier of (i)the sale of all the Shares subject to the Equity Distribution Agreement, or (ii)termination of the Equity Distribution Agreement in accordance with its terms.

The foregoing description of the Equity Distribution Agreement does not purport to be complete and is qualified in its entirety by reference to the full Equity Distribution Agreement, a copy of which is attached hereto as Exhibit 10.1 and is incorporated by reference herein.

A copy of the opinion of Gunderson Dettmer Stough Villeneuve Franklin& Hachigian, LLP relating to the validity of the issuance and sale of the Shares in the offering is attached as Exhibit 5.1 hereto.

This Current Report on Form 8-K does not constitute an offer to sell the Shares or a solicitation of an offer to buy the Shares, nor shall there be any sale of the Shares in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On March15, 2018, Histogenics issued a press release and is holding a conference call regarding its results of operations and financial condition for the full year and quarter ended December31, 2017. The press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.

Various statements to be made during the conference call 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: the timing and success of Histogenics’ NeoCart Phase 3 clinical trial, including, without limitation, possible delays in generating the data from the clinical trial; the ability to obtain and maintain regulatory approval of NeoCart or any product candidates, and the labeling for any approved products; MEDINET’s ability to initiate NeoCart Clinical development in Japan in a timely manner; NeoCart’s regulation as a Regenerative Medical Product; the market size and potential patient population in Japan; 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 our technology transfer and manufacturing location transition; the size and growth of the potential markets for Histogenics’ product candidates and the ability to serve those markets; Histogenics’ expectations regarding its expenses and revenue; 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 December31, 2017, which is on file with the SEC and available on the SEC’s website at www.sec.gov. 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.

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 conveyed on the conference call will be provided only as of the date of the call, and Histogenics undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements made during the call after the date thereof, whether as a result of new information, future events or otherwise.

The information in Item 1.01 of this Current Report on Form8-K and Exhibit 99.1 attached hereto shall not be deemed “filed” for purposes of Section18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act or the Exchange Act, except as expressly set forth by specific reference in such a filing.

(d)Exhibits.

HISTOGENICS CORP Exhibit
EX-5.1 2 d551593dex51.htm EX-5.1 EX-5.1 Exhibit 5.1 March 15,…
To view the full exhibit click here

About HISTOGENICS CORPORATION (NASDAQ:HSGX)

Histogenics Corporation is a regenerative medicine company. The Company is focused on developing and commercializing products in the musculoskeletal segment of the marketplace. The Company’s product candidate, NeoCart utilizes various aspects of regenerative medicine platform to develop a tissue implant intended to treat tissue injury in the field of orthopedics, specifically cartilage damage in the knee. NeoCart is a cartilage-like implant created using a patient’s own cartilage cells through a series of tissue engineering processes. The patient’s cells are separated from a tissue biopsy specimen extracted from the patient and multiplied in its laboratory. The cells are then infused into its scaffold that provides structure for the developing implant. Before NeoCart is implanted in a patient, the cell- and scaffold construct undergoes a bioengineering process in the Company’s Tissue Engineering Processor (TEP). The Company has operations in the United States and Israel.