SC 13D/A

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

SCHEDULE 13D

(Amendment No. 1)

Under the Securities Exchange Act of 1934

 

 

TAYSHA GENE THERAPIES, INC.

(Name of Issuer)

Common Stock, par value $0.00001

(Title of Class of Securities)

877619106

(CUSIP Number)

Astellas Gene Therapies, Inc.

f/k/a Audentes Therapeutics, Inc.

225 Gateway Boulevard

South San Francisco, CA 94080

Attention: President

(415) 818-1005

 

 

With a copy to:

Astellas US LLC

1 Astellas Way

Northbrook, IL 60062

Attn: General Counsel

(Name, Address and Telephone Number of Person

Authorized to Receive Notices and Communications)

August 16, 2023

(Date of Event Which Requires Filing of this Statement)

 

 

If the filing person has previously filed a statement on Schedule 13G to report the acquisition that is the subject of this Schedule 13D, and is filing this schedule because of § 240.13d-1(e), 240.13d-1(f) or 240.13d-1(g), check the following box  ☐.

 

*

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).

 

 

 


SCHEDULE 13D

CUSIP No. 877619106

 

  1    

  NAME OF REPORTING PERSONS

 

  Astellas Pharma Inc.

  2  

  CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP (See Instructions)

  (a)  ☐        (b)  ☒

 

  3  

  SEC USE ONLY

 

  4  

  SOURCE OF FUNDS (See Instructions)

 

  WC

  5  

  CHECK BOX IF DISCLOSURE OF LEGAL PROCEEDINGS IS REQUIRED PURSUANT TO ITEMS 2(d) or 2(e)

 

  ☐

  6  

  CITIZENSHIP OR PLACE OF ORGANIZATION

 

  Japan

NUMBER OF

SHARES

 BENEFICIALLY 

OWNED BY

EACH

REPORTING

PERSON

WITH

 

     7    

  SOLE VOTING POWER

 

  0

     8  

  SHARED VOTING POWER

 

  7,266,342 (1)

     9  

  SOLE DISPOSITIVE POWER

 

  0

   10  

  SHARED DISPOSITIVE POWER

 

  7,266,342 (1)

11    

  AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON

 

  7,266,342 (1)

12  

  CHECK BOX IF THE AGGREGATE AMOUNT IN ROW (11) EXCLUDES CERTAIN SHARES (See Instructions)

 

  ☐

13  

  PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW (11)

 

  3.89% (2)

14  

  TYPE OF REPORTING PERSON (See Instructions)

 

  CO

 

(1)

Represents shares directly held by Astellas Gene Therapies, Inc. f/k/a Audentes Therapeutics, Inc., a wholly owned direct subsidiary of Astellas US Holding, Inc., which is in turn a wholly owned direct subsidiary of Astellas Pharma Inc. Astellas Pharma Inc., Astellas US Holding, Inc. and Astellas Gene Therapies, Inc. may each be deemed to have shared voting and dispositive power over all of the shares.

(2)

Based upon the sum of (i) 64,465,037 shares of the Issuer’s Common Stock outstanding as of August 14, 2023, as reported by the Issuer in its Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2023, filed with the U.S. Securities and Exchange Commission on August 14, 2023 (the “Q2 2023 10-Q”) and (ii) an additional 122,412,376 shares of the Issuer’s Common Stock outstanding following the closing of the private placement contemplated by that certain Securities Purchase Agreement by and among the Issuer and the investors party thereto, dated August 14, 2023 (the “August 2023 PIPE SPA”).

 

2


CUSIP No. 877619106

 

  1    

  NAME OF REPORTING PERSONS

 

  Astellas US Holding, Inc.

  2  

  CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP (See Instructions)

  (a)  ☐        (b)  ☒

 

  3  

  SEC USE ONLY

 

  4  

  SOURCE OF FUNDS (See Instructions)

 

  WC

  5  

  CHECK BOX IF DISCLOSURE OF LEGAL PROCEEDINGS IS REQUIRED PURSUANT TO ITEMS 2(d) or 2(e)

 

  ☐

  6  

  CITIZENSHIP OR PLACE OF ORGANIZATION

 

  Delaware

NUMBER OF

SHARES

 BENEFICIALLY 

OWNED BY

EACH

REPORTING

PERSON

WITH

 

     7    

  SOLE VOTING POWER

 

  0

     8  

  SHARED VOTING POWER

 

  7,266,342 (1)

     9  

  SOLE DISPOSITIVE POWER

 

  0

   10  

  SHARED DISPOSITIVE POWER

 

  7,266,342 (1)

11    

  AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON

 

  7,266,342 (1)

12  

  CHECK BOX IF THE AGGREGATE AMOUNT IN ROW (11) EXCLUDES CERTAIN SHARES (See Instructions)

 

  ☐

13  

  PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW (11)

 

  3.89% (2)

14  

  TYPE OF REPORTING PERSON (See Instructions)

 

  CO

 

(1)

Represents shares directly held by Astellas Gene Therapies, Inc. f/k/a Audentes Therapeutics, Inc., a wholly owned direct subsidiary of Astellas US Holding, Inc., which is in turn a wholly owned direct subsidiary of Astellas Pharma Inc. Astellas Pharma Inc., Astellas US Holding, Inc. and Astellas Gene Therapies, Inc. may each be deemed to have shared voting and dispositive power over all of the shares.

(2)

Based upon the sum of (i) 64,465,037 shares of the Issuer’s Common Stock outstanding as of August 14, 2023, as reported by the Issuer in its Q2 2023 10-Q and (ii) an additional 122,412,376 shares of the Issuer’s Common Stock outstanding following the closing of the private placement contemplated by the August 2023 PIPE SPA.

 

3


CUSIP No. 877619106

 

  1    

  NAME OF REPORTING PERSONS

 

  Astellas Gene Therapies, Inc. (f/k/a Audentes Therapeutics, Inc.)

  2  

  CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP (See Instructions)

  (a)  ☐        (b)  ☒

 

  3  

  SEC USE ONLY

 

  4  

  SOURCE OF FUNDS (See Instructions)

 

  WC

  5  

  CHECK BOX IF DISCLOSURE OF LEGAL PROCEEDINGS IS REQUIRED PURSUANT TO ITEMS 2(d) or 2(e)

 

  ☐

  6  

  CITIZENSHIP OR PLACE OF ORGANIZATION

 

  Delaware

NUMBER OF

SHARES

 BENEFICIALLY 

OWNED BY

EACH

REPORTING

PERSON

WITH

 

     7    

  SOLE VOTING POWER

 

  0

     8  

  SHARED VOTING POWER

 

  7,266,342 (1)

     9  

  SOLE DISPOSITIVE POWER

 

  0

   10  

  SHARED DISPOSITIVE POWER

 

  7,266,342 (1)

11    

  AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON

 

  7,266,342 (1)

12  

  CHECK BOX IF THE AGGREGATE AMOUNT IN ROW (11) EXCLUDES CERTAIN SHARES (See Instructions)

 

  ☐

13  

  PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW (11)

 

  3.89% (2)

14  

  TYPE OF REPORTING PERSON (See Instructions)

 

  CO

 

(1)

Represents shares directly held by Astellas Gene Therapies, Inc. f/k/a Audentes Therapeutics, Inc., a wholly owned direct subsidiary of Astellas US Holding, Inc., which is in turn a wholly owned direct subsidiary of Astellas Pharma Inc. Astellas Pharma Inc., Astellas US Holding, Inc. and Astellas Gene Therapies, Inc. may each be deemed to have shared voting and dispositive power over all of the shares.

(2)

Based upon the sum of (i) 64,465,037 shares of the Issuer’s Common Stock outstanding as of August 14, 2023, as reported by the Issuer in its Q2 2023 10-Q and (ii) an additional 122,412,376 shares of the Issuer’s Common Stock outstanding following the closing of the private placement contemplated by the August 2023 PIPE SPA.

 

4


This Amendment No. 1 (“Amendment No. 1”) amends and supplements the initial statement on Schedule 13D filed on October 31, 2022 (the “Initial Statement”). Except as specifically provided herein, this Amendment No. 1 does not modify any of the information previously reported in the Initial Statement. Capitalized terms used but not defined in this Amendment No. 1 shall have the meanings ascribed to them in the Initial Statement.

This Amendment No. 1 is being filed to update the aggregate percentage of the Issuer’s Common Stock owned by the Reporting Persons due to dilution caused by the Issuer’s issuance of additional shares of Common Stock pursuant to the August 2023 PIPE SPA and not in connection with a disposition or acquisition of any shares of Common Stock by the Reporting Persons.

 

Item 2.

Identity and Background

Item 2 of the Initial Statement is hereby amended and restated in its entirety as follows:

This Amendment No. 1 is being filed on behalf of each of the following persons (each a “Reporting Person” and, collectively, the “Reporting Persons”):

(i) Astellas Pharma Inc., a company incorporated under the laws of Japan (“Astellas”), with its principal business address at 2-5-1, Nihonbashi-Honcho, Chuo-Ku, Tokyo 103-8411, Japan;

(ii) Astellas US Holding, Inc., a company incorporated under the laws of Delaware (“Astellas US”), with its principal business address at 2375 Waterview Drive, Northbrook, IL 60062; and

(iii) Astellas Gene Therapies, Inc. f/k/a Audentes Therapeutics, Inc., a company incorporated under the laws of Delaware (“Astellas Gene Therapies”), with its principal business address at 225 Gateway Boulevard, South San Francisco, CA 94080.

The Reporting Persons are part of a pharmaceutical business operating in more than 70 countries around the world. The business is promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality.

The directors and executive officers of each Reporting Person are set forth on Schedule I, attached hereto. Schedule I sets forth the following information with respect to each such person:

(a) name;

(b) business address;

(c) position with the Reporting Person and present principal occupation or employment (if different) and, for persons not employed by the Reporting Persons, the name, principal business and address of any corporation or other organization in which such employment is conducted; and

(f) citizenship.

During the last five years, neither the Reporting Persons nor any person named in Schedule I have been (i) convicted in a criminal proceeding (excluding traffic violations or similar misdemeanors) or (ii) a party to a civil proceeding of a judicial or administrative body of competent jurisdiction, as a result of which, he, she or it was or is subject to a judgment, decree or final order enjoining future violations of, or prohibiting or mandating activities subject to, federal or state securities laws or finding any violation with respect to such laws.


Item 5.

Interest in Securities of the Issuer

Item 5 of the Initial Statement is hereby amended and restated as follows:

(a)-(b)

Number of shares of Common Stock beneficially owned:

 

Astellas

     7,266,342 shares  

Astellas US

     7,266,342 shares  

Astellas Gene Therapies

     7,266,342 shares  

Percent of class:

 

Astellas

     3.89

Astellas US

     3.89

Astellas Gene Therapies

     3.89

The percentage ownership was calculated based upon the sum of (i) 64,465,037 shares of the Issuer’s Common Stock outstanding as of August 14, 2023, as reported by the Issuer in its Q2 2023 10-Q and (ii) an additional 122,412,376 shares of the Issuer’s Common Stock outstanding following the closing of the private placement contemplated by the August 2023 PIPE SPA.

Number of shares of Common Stock as to which such person has:

 

(i)

Sole power to vote or to direct the vote:

 

Astellas

     0 shares  

Astellas US

     0 shares  

Astellas Gene Therapies

     0 shares  

 

(ii)

Shared power to vote or to direct the vote:

 

Astellas

     7,266,342 shares  

Astellas US

     7,266,342 shares  

Astellas Gene Therapies

     7,266,342 shares  

 

(iii)

Sole power to dispose or to direct the disposition of:

 

Astellas

     0 shares  

Astellas US

     0 shares  

Astellas Gene Therapies

     0 shares  

 

(iv)

Shared power to dispose or to direct the disposition of:

 

Astellas

     7,266,342 shares  

Astellas US

     7,266,342 shares  

Astellas Gene Therapies

     7,266,342 shares  

None of the individuals listed on Schedule I beneficially owns any of the Issuer’s Common Stock.

(c) Neither the Reporting Persons nor any of the individuals listed on Schedule I have effected any transactions in the Common Stock during the past sixty (60) days.

(d) Not applicable.

(e) The Reporting Persons ceased to be beneficial owners of more than five percent of the Common Stock on August 16, 2023.


SIGNATURE

After reasonable inquiry and to the best of each of the undersigned’s knowledge and belief, each of the undersigned certifies that the information set forth in this statement is true, complete and correct.

 

Date: August 18, 2023     ASTELLAS PHARMA INC.
    By:   /s/ Chad Diehl
    Name: Chad Diehl
    Title: Attorney-in-Fact*
Date: August 18, 2023     ASTELLAS US HOLDING, INC.
    By:   /s/ Chad Diehl
    Name: Chad Diehl
    Title: Attorney-in-Fact*
Date: August 18, 2023     ASTELLAS GENE THERAPIES, INC.
    By:   /s/ Chad Diehl
    Name: Chad Diehl
    Title: Attorney-in-Fact*

 

*

Powers of Attorney filed as Exhibits 1, 2 and 3, respectively, to the Initial Statement and incorporated herein by reference.


Schedule I

Astellas Pharma Inc.

The name and present principal occupation of each of the executive officers and directors of Astellas Pharma Inc. are set forth below. Unless otherwise noted, each of these persons has as their business address 2-5-1, Nihonbashi-Honcho, Chuo-Ku, Tokyo 103-8411, Japan.

 

Name

  

Position with Astellas

Pharma Inc.

  

If other than Astellas

Pharma Inc., Principal

Occupation and Name,

Principal Business and

Address of Employer

  

Citizenship

Kenji Yasukawa    Representative Director, Chairman of the Board    Company Director    Japan
Naoki Okamura    Representative Director, President, Chief Executive Officer and Chief Financial Officer       Japan
Katsuyoshi Sugita    Representative Director, Executive Vice President, Chief People Officer and Chief Ethics & Compliance Officer       Japan
Takashi Tanaka    Outside Director   

Chairman and Executive Director

KDDI CORPORATION

3-10-10 Iidabashi,

Chiyoda-ku

Tokyo 102-8460

Japan

   Japan
Eriko Sakurai    Outside Director    Company Director    Japan
Masahiro Miyazaki    Outside Director    Company Director    Japan
Yoichi Ohno    Outside Director   

Visiting Professor, Social Medicine,

Research Administration Center and Medical Education Center,

Saitama Medical University

Saitama 350-0495, Japan

   Japan
Toru Yoshimitsu    Director, Audit & Supervisory Committee Member    Audit & Supervisory Committee    Japan
Raita Takahashi    Outside Director, Audit & Supervisory Committee Member   

Certified Public Accountant

Takahashi Raita CPA Office

Gionnosucho 5 kagoshima Japan

   Japan
Mika Nakayama    Outside Director, Audit & Supervisory Committee Member    Company Director    Japan


Rie Akiyama    Outside Director, Audit & Supervisory Committee Member   

Baba & Sawada Law Office

Nittochi Uchisaiwaicho Building 7F,

1-2-1 Uchisaiwaicho,

Chiyoda-ku, Tokyo 100-0011

Japan

   Japan
Claus Zieler    Chief Commercial Officer   

Chief Commercial Officer

Astellas Pharma Europe Ltd.

Bourne Business Park

300 Dashwood Lang Road Addlestone KT15 2NX

United Kingdom

   Germany
Yoshitsugu Shitaka, Ph.D.    Chief Scientific Officer       Japan
Catherine Levitt    General Counsel   

General Counsel,

Astellas US LLC,

2375 Waterview Drive

Northbrook, IL 60062

   United States
Hideki Shima    Chief Manufacturing Officer       Japan
Tadaaki Taniguchi, M.D., Ph.D.    Chief Medical Officer   

Chief Medical Officer

Astellas Pharma Global Development, Inc.

2375 Waterview Drive

Northbrook, IL 60062

   Japan
Adam Pearson    Chief Strategy Officer       United Kingdom


Astellas US Holding, Inc.

The name and present principal occupation of each of the executive officers and directors of Astellas US Holding, Inc. are set forth below. Unless otherwise noted, each of these persons has as their business address 2375 Waterview Drive, Northbrook, IL 60062.

 

Name

  

Position with Astellas US

Holding, Inc.

  

If other than Astellas US

Holding, Inc., Principal

Occupation and Name,

Principal Business and

Address of Employer

  

Citizenship

Mark Reisenauer    Director   

President US Commercial

Astellas US LLC

2375 Waterview Drive

Northbrook, IL 60062

   United States
Marloes Schaddelee    Director   

Head of Governance, Risk and Strategy Operations

Astellas B.V.

Sylviusweg 62, 2333 BE Leiden, Netherlands

   The Netherlands
Frank Hudson    Director   

Senior Vice President, Head of Corporate Finance and Control

Astellas US LLC

2375 Waterview Drive

Northbrook, IL 60062

   United States
Karissa Marcello    Treasurer   

Executive Director, Commercial Finance U.S.

Astellas US LLC

2375 Waterview Drive

Northbrook, IL 60062

   United States
Nahrin Marino    Secretary   

Senior Vice President, Legal Head of Commercial, Regulatory and Privacy

Astellas US LLC

2375 Waterview Drive

Northbrook, IL 60062

   United States
Molly McCoy    Assistant Secretary   

Executive Director, Legal Commercial Lead US

Astellas US LLC

2375 Waterview Drive

Northbrook, IL 60062

   United States


Astellas Gene Therapies, Inc.

The name and present principal occupation of each of the executive officers and directors of Audentes Therapeutics, Inc. are set forth below. Unless otherwise noted, each of these persons has as their business address 225 Gateway Boulevard, South San Francisco, CA 94080.

 

Name

  

Position with Astellas Gene

Therapies, Inc

  

If other than Astellas Gene

Therapies, Inc., Principal

Occupation and Name,

Principal Business and

Address of Employer

  

Citizenship

Mark Reisenauer    Director   

President

Astellas US LLC

2375 Waterview Drive

Northbrook, IL 60062

   United States
Marloes Schaddelee    Director   

Executive Director, Governance and Strategy

Astellas B.V.

Sylviusweg 62, 2333 BE Leiden, Netherlands

   The Netherlands
Nahrin Marino    Secretary   

Senior Vice President, Legal Head of Commercial, Regulatory and Privacy

Astellas US LLC

2375 Waterview Drive

Northbrook, IL 60062

   United States
Molly McCoy    Assistant Secretary   

Executive Director, Legal Commercial Lead US

Astellas US LLC

2375 Waterview Drive

Northbrook, IL 60062

   United States
Patrick Ruane    Director, Treasurer, Vice President and Head of R&D Finance       United States
Morten Sogaard    Director, President, Senior Vice President and Head of Gene Therapy Research & Technical Operations       Denmark and United States