UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
 
FORM 6-K
 
 
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13A-16 OR 15D-16 UNDER THE
SECURITIES EXCHANGE ACT OF 1934
 
Dated March 2, 2017
 
Commission File Number 001-36421
 
 
AURINIA PHARMACEUTICALS INC.
(Exact name of Registrant as specified in its charter)
 
N/A
(Translation of Registrant’s Name)
 
#1203-4464 Markham Street
Victoria, British Columbia
V8Z7X8
(250) 708-4272
(Address and telephone number of registrant’s principal executive offices)
 


 
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

 
Form 20-F   ☐             Form 40-F   ☒

 
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b) (1):   ☐
 
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b) (7):   ☐
 
Indicate by check mark whether by furnishing the information contained in this Form, the registrant is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.

 
Yes   ☒              No   ☐

 
This Form 6-K is hereby filed and incorporated by reference into the Registrant’s Registration Statement on Form F-10 (File No. 333-206994).
 


 
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, thereunto duly authorized.

 
Dated: March 2, 2017.
 
 
Aurinia Pharmaceuticals Inc.
 
       
 
By:
/s/ Dennis Bourgeault   
    Name: Dennis Bourgeault  
    Title:   Chief Financial Officer  
       
 
 
 
 
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EXHIBIT INDEX
 
 
 
Exhibit
 
Description of Exhibit
   
99.1
Material Change Report dated March 2, 2017

Exhibit 99.1 included with this report on Form 6-K is hereby incorporated by reference as an exhibit to the Registrant’s Registration Statement on Form F-10 (File No. 333-206994), as amended or supplemented.
 
 

3
Exhibit 99.1
 
FORM 51-102F3
 
MATERIAL CHANGE REPORT
 
ITEM 1.
Name and Address of Company
 
 
 
Aurinia Pharmaceuticals Inc. (the “ Company ”)
 
1203 – 4464 Markham Street
 
Victoria, BC V8Z 7X8
 
 
ITEM 2.
Date of Material Change
 
 
 
March 1, 2017
 
 
ITEM 3.
News Release
 
 
 
A news release relating to the material change described herein was disseminated on March 1, 2017 via Business Wire.
 
 
ITEM 4.
Summary of Material Change
 
 
 
The Company announced top-line results from its Phase 2b AURA-LV study in lupus nephritis (“ LN ”).
 
 
ITEM 5.
Full Description of Material Change
 
 
 
The Company announced top-line results from our Phase 2b AURA-LV (AURA) study in LN. At 48 weeks, the trial met the complete and partial remission (“CR”/ “PR”) endpoints, demonstrating statistically significantly greater CR and PR in patients in both low dose (23.7mg of voclosporin twice daily (p<.001)) and high dose (39.5mg twice daily (p=.026)) cohorts versus the control group.
 
 
 
Each arm of the study included the current standard of care of mycophenolate mofetil as background therapy and a forced steroid taper to 5mg/day by week 8 and 2.5mg by week 16. No unexpected safety signals were observed and there were no additional deaths in the voclosporin treated patients; however, there were three deaths and one malignancy reported in the control arm after completion of the study treatment period.
 
 
 
The 24 and 48-week top-line efficacy results are summarized below:
 
 
 
 
 
Endpoint 
 
Treatment
 
24 weeks
 
Odds ratio
 
P-value*
 
48 weeks
 
Odds Ratio
 
P-value*
                             
   
23.7mg VCS BID
 
33%
 
2.03
 
p=.045
 
49%
 
3.21
 
p<.001
                             
Complete 
 
39.5mg VCS BID
 
27%
 
1.59
 
p=.204
 
40%
 
2.10
 
p=.026
Remission 
                           
                             
   
Control Arm
 
19%
 
NA
 
NA
 
24%
 
NA
 
NA
                             
   
23.7mg VCS BID
 
70%
 
2.33
 
p=.007
 
68%
 
2.34
 
p=.007
                             
Partial Remission
 
39.5mg VCS BID
 
66%
 
2.03
 
p=.024
 
72%
 
2.68
 
p=.002
                             
   
Control Arm
 
49%
 
NA
 
NA
 
48%
 
NA
 
NA
                             
                             
*All p-values are vs control                        
 
 
 
 
 
ITEM 5.2.
Disclosure of Restructuring Transactions
 
 
 
Not applicable.
 
 
ITEM 6.
Reliance on Subsection 7.1(2) of National Instrument 51-102
 
 
 
Not applicable.
 
 
ITEM 7.
Omitted Information
 
 
 
There are no significant facts required to be disclosed herein which have been omitted.
 
 
ITEM 8.
Executive Officer
 
 
 
For further information, please contact:
   
  Michael R. Martin, Chief Operating Officer
 
250-415-9713 
  mmartin@auriniapharma.com 
   
ITEM 9.
Date of Report
   
  March 2, 2017 
 
 
 
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