RFL Rafael

Filed: 28 Oct 21, 7:44am





Washington, D.C. 20549










Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934


Date of Report (Date of earliest event reported): October 28, 2021





(Exact name of registrant as specified in its charter)




Delaware 1-38411 82-2296593

(State or other jurisdiction

of Incorporation)

 (Commission File Number) 

(IRS Employer

Identification No.) 


520 Broad Street

Newark, New Jersey 

(Address of principal executive offices) (Zip Code)


Registrant’s telephone number, including area code: 212 658-1450


Not Applicable 

(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 (see General Instruction A.2. below):


¨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))


Indicate by check mark whether the registrant is an emerging growth company 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.   


Securities registered pursuant to Section 12(b)-2 of the Exchange Act:


Title of each class Trading Symbol 

Name of each exchange on

which registered

Class B common stock, par value $0.1 per share RFL New York Stock Exchange







Item 7.01 Regulation FD Disclosure.


On October 28, 2021, Rafael Holdings, Inc. (the “Registrant”) issued the attached release (the “Release”) providing an update on Rafael Pharmaceuticals’ AVENGER 500 Phase 3 Trial of CPI-613® (Devimistat) in Metastatic Pancreatic Cancer and Interim Analysis of ARMADA 2000 Phase 3 Trial in Relapsed or Refractory Acute Myeloid Leukemia. A copy of the Release is furnished herewith as Exhibit 99.1 and is incorporated herein by reference.


The Registrant is furnishing the information contained in this Report, including Exhibit 99.1, pursuant to Item 7.01 of Form 8-K promulgated by the Securities and Exchange Commission (the “SEC”). This information shall not be deemed to be “filed” with the SEC or incorporated by reference into any other filing with the SEC.


Item 8.01 Other Events.


The AVENGER 500 Phase 3 clinical trial for CPI-613® (devimistat), Rafael Pharmaceuticals’ lead product candidate, did not meet its primary endpoint of significant improvement in overall survival in patients with metastatic adenocarcinoma of the pancreas.


Following a pre-specified interim analysis, the independent data monitoring committee has recommended the ARMADA 2000 clinical trial of devimistat for patients with relapsed or refractory acute myeloid leukemia be stopped due to lack of efficacy.


Item 9.01 Financial Statements and Exhibits.


(d) Exhibits.


Exhibit No




Press Release, dated October 28, 2021.


Cover Page Interactive Data File (embedded within the Inline XBRL document)






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.




/s/ Ameet Mallik
   Name:Ameet Mallik
  Title:Chief Executive Officer

Dated: October 28, 2021











Press Release, dated October 28, 2021.


Cover Page Interactive Data File (embedded within the Inline XBRL document)