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EX-99.1 - EXHIBIT 99.1 - Prevail Therapeutics Inc.d861073dex991.htm

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): January 9, 2020

 

 

Prevail Therapeutics Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-38939   82-2129632

(state or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification No.)

430 East 29th Street, Suite 1520

New York, New York

  10016
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code: (917) 336-9310

 

(Former name or former address, if changed since last report.)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange

on which registered

Common Stock, par value $0.0001 per share   PRVL   The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b–2 of the Securities Exchange Act of 1934 (§ 240.12b–2 of this chapter).

Emerging growth company  ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☒

 

 

 


Item 8.01. Other Information.

On January 9, 2020, Prevail Therapeutics Inc. issued a press release announcing that it has granted a compassionate use request for the administration of PR001 to a single patient with Type 2 Gaucher disease, and separately that the Company is proceeding with its Phase 1/2 clinical trial for the treatment of neuronopathic Gaucher disease and expects to initiate patient dosing during the first half of 2020.

A copy of this press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit
No.
  

Description

99.1    Press Release dated January 9, 2020.


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

PREVAIL THERAPEUTICS INC.
By:       /s/ Asa Abeliovich, M.D., Ph.D.
  Asa Abeliovich, M.D., Ph.D.
 

President and Chief Executive Officer

Dated: January 9, 2020