UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

 

SCHEDULE 13G

 

Under the Securities Exchange Act of 1934
(Amendment No. 1)*

 

Ayala Pharmaceuticals, Inc.

(Name of Issuer)

 

Common Stock, $0.01 par value per share

(Title of Class of Securities)

 

05465V108

(CUSIP Number)

 

October 19, 2022

(Date of Event which Requires Filing of this Statement)

 

Check the appropriate box to designate the rule pursuant to which this Schedule is filed:

 

¨  Rule 13d-1(b)

¨ Rule 13d-1(c)

x  Rule 13d-1(d)

 

* The remainder of this cover page shall be filled out for a reporting person's initial filing on this form with respect to the subject class of securities, and for any subsequent amendment containing information which would alter disclosures provided in a prior cover page.

 

The information required on the remainder of this cover page shall not be deemed to be "filed" for the purpose of Section 18 of the Securities Exchange Act of 1934 ("Act") or otherwise subject to the liabilities of that section of the Act but shall be subject to all other provisions of the Act (however, see the Notes).

 

 

 

 

 

 

CUSIP No. 05465V108   13G   Page 2 of 6 Pages

 

1.  

NAMES OF REPORTING PERSONS

 

Novartis Institutes for BioMedical Research, Inc.

2.  

CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP
(see instructions)
(a)    
¨

(b)    ¨

3.   SEC USE ONLY
 
4.  

CITIZENSHIP OR PLACE OF ORGANIZATION
 

Delaware

NUMBER OF
SHARES
BENEFICIALLY
OWNED BY
EACH
REPORTING
PERSON WITH
  5.   SOLE VOTING POWER
 
0
  6.   SHARED VOTING POWER
 
698,777
  7.   SOLE DISPOSITIVE POWER
 
0
  8.   SHARED DISPOSITIVE POWER
 
698,777

9.  

AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON

 

698,777

10.  

CHECK IF THE AGGREGATE AMOUNT IN ROW (9) EXCLUDES CERTAIN SHARES

(see instructions)    ¨

 

11.  

PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW (9)

 

4.7% (1)

12.  

TYPE OF REPORTING PERSON (see instructions)

 

CO

 

(1) Percentage based on 14,833,327 Shares outstanding on October 14, 2022, as reported by the Issuer in its Form 8-K filed with the SEC on October 19, 2022.

 

(The terms used above are defined in the Explanatory Note of this Schedule 13G Amendment)

 

 

 

 

CUSIP No. 05465V108   13G   Page 3 of 6 Pages

 

1.  

NAMES OF REPORTING PERSONS

 

Novartis AG

2.  

CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP
(see instructions)
(a)    
¨

(b)    ¨

3.   SEC USE ONLY
 
4.  

CITIZENSHIP OR PLACE OF ORGANIZATION
 

Switzerland

NUMBER OF
SHARES
BENEFICIALLY
OWNED BY
EACH
REPORTING
PERSON WITH
  5.   SOLE VOTING POWER
 
0
  6.   SHARED VOTING POWER
 
698,777
  7.   SOLE DISPOSITIVE POWER
 
0
  8.   SHARED DISPOSITIVE POWER
 
698,777

9.  

AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON

 

698,777

10.  

CHECK IF THE AGGREGATE AMOUNT IN ROW (9) EXCLUDES CERTAIN SHARES

(see instructions)    ¨

 

11.  

PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW (9)

 

4.7% (1)

12.  

TYPE OF REPORTING PERSON (see instructions)

 

CO, HC

 

(1) Percentage based on 14,833,327 Shares outstanding on October 14, 2022, as reported by the Issuer in its Form 8-K filed with the SEC on October 19, 2022.

 

(The terms used above are defined in the Explanatory Note of this Schedule 13G Amendment)

 

 

 

 

CUSIP No. 05465V108   13G   Page 4 of 6 Pages

 

EXPLANATORY NOTE

 

This Amendment No. 1 (this “Schedule 13G Amendment”) to the Schedule 13G filed with the U.S. Securities and Exchange Commission (the “SEC”) on February 5, 2021 is being filed on behalf of Novartis AG, a Swiss corporation (“Novartis AG”), and its wholly owned subsidiary Novartis Institutes for BioMedical Research, Inc., a Delaware corporation (“NIBRI”, and together with Novartis AG, the “Reporting Persons”), with respect to the common stock, par value $0.01 per share (the “Shares”), of Ayala Pharmaceuticals, Inc., a Delaware corporation (the “Issuer”).

 

Capitalized terms used in this Schedule 13G Amendment which are not defined herein have the meanings given to them in the original Schedule 13G.

 

Item 1.

 

  (a)

Name of Issuer


Ayala Pharmaceuticals, Inc.

     
  (b)

Address of Issuer’s Principal Executive Offices

 

Oppenheimer 4, Rehovot, Israel 7670104

 

Item 2.

 

  (a)

Name of Person Filing

 

This statement is filed on behalf of the following persons with respect to Shares of the Issuer:

 

(i) NIBRI, a Delaware corporation, with respect to shares held by it; and

 

(ii) Novartis AG, a Swiss corporation, as the publicly owned parent of NIBRI, with respect to the shares held by NIBRI.

     
  (b)

Address of the Principal Office or, if none, residence

 

The address of the principal business office of NIBRI is 250 Massachusetts Avenue, Cambridge, MA 02139.

 

The address of the principal business office of Novartis AG is Lichtstrasse 35, 4056 Basel, Switzerland.

     
  (c)

Citizenship

 

NIBRI is a corporation organized under the laws of Delaware and is an indirect wholly-owned subsidiary of Novartis AG.

 

Novartis AG is a corporation organized under the laws of Switzerland and is the publicly owned parent of NIBRI.

     
  (d)

Title of Class of Securities

 

Common Stock, par value $0.01 per share.

     
  (e)

CUSIP Number


05465V108

 

 

 

 

CUSIP No. 05465V108   13G   Page 5 of 6 Pages

 

Item 3.If this statement is filed pursuant to §§240.13d-1(b), or 240.13d-2(b) or (c), check whether the person filing is a:

 

Not applicable.

 

Item 4.Ownership.

 

The information required by Items 4(a)-(c) is set forth in Rows 5-11 of the cover pages hereto for each Reporting Person and is incorporated herein by reference for each Reporting Person.

 

Item 5.Ownership of Five Percent or Less of a Class.

 

If this statement is being filed to report the fact that as of the date hereof the reporting person has ceased to be the beneficial owner of more than 5 percent of the class of securities, check the following .

 

Item 6. Ownership of More than Five Percent on Behalf of Another Person.

 

Not Applicable.

 

Item 7.

Identification and Classification of the Subsidiary Which Acquired the Security Being Reported on By the Parent Holding Company or Control Person.

 

Not Applicable.

 

Item 8. Identification and Classification of Members of the Group.

 

Not Applicable.

 

Item 9. Notice of Dissolution of Group.

 

Not Applicable.

 

Item 10. Certification.

 

Not Applicable.

 

 

 

 

CUSIP No. 05465V108   13G   Page 6 of 6 Pages

 

SIGNATURES

 

After reasonable inquiry and to the best of my knowledge and belief, I certify that the information set forth in this statement is true, complete and correct.

 

Dated: October 31, 2022

 

  NOVARTIS INSTITUTES FOR BIOMEDICAL RESEARCH, INC.
   
  By: /s/ Scott Brown
   

Name: Scott Brown

Title: VP General Counsel

 

 

NOVARTIS AG

   
  By:   /s/ Lukas Förtsch
   

Name: Lukas Förtsch

Title: Authorized Signatory

 

  By:   /s/ Daniel Weiss
   

Name: Daniel Weiss

Title: Authorized Signatory

 

 

 

 

EXHIBIT INDEX

 

Exhibit Number Exhibit Description
   
99.2 Evidence of Signatory Authority

 

 

 

 

EXHIBIT 99.2

 

EVIDENCE OF SIGNATORY AUTHORITY

 

Excerpt from Commercial Register of Novartis AG

 

Identification number Legal status Entry Cancelled    
          1
CHE-103.867.266 Limited or Corporation 01.03.1996      

 

All data

 

In Ca Business name Ref Legal seat
1   Novartis AG 1 Basel
1   (Novartis SA) (Novartis Inc.)    

 

CHE-103.867.266 Novartis AG Basel 1
All data            
In Mo Ca Personal Data Function Signature
14    

Förtsch, Lukas, von Zürich, in Sissach

  joint signature at two

 

CHE-103.867.266 Novartis AG Basel 1
All data            
In Mo Ca Personal Data Function Signature

1

   

Weiss, Daniel Andreas, von Basel, in Biel-Benken

  joint signature at two