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6-K
MESOBLAST LTD filed this Form 6-K on 10/17/2018
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meso-6k_20181012.htm

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

For the month of October 2018

Commission File Number 001-37626

Mesoblast Limited

(Exact name of Registrant as specified in its charter)

Not Applicable

(Translation of Registrant’s name into English)

Australia
(
Jurisdiction of incorporation or organization)

 

Silviu Itescu

Chief Executive Officer and Executive Director

Level 38

55 Collins Street

Melbourne 3000

Australia

(Address of principal executive offices)

 

Indicate by check mark whether the registrant files or will file annual reports under cover 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):

Yes No

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):

Yes No

 


INFORMATION CONTAINED ON THIS REPORT ON FORM 6-K

On October 12, 2018, Mesoblast Limited filed with the Australian Securities Exchange a new release announcement, which is attached hereto as Exhibit 99.1, and is incorporated herein by reference.

On October 12, 2018, Mesoblast Limited filed with the Australian Securities Exchange a new issue announcement, application for quotation of additional securities and agreement (Appendix 3B), which is attached hereto as Exhibit 99.2, and is incorporated herein by reference.

 


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 organized.

 

 

 

 

 

 

 

 

Mesoblast Limited

 

 

 

 

 

 

/s/ Charlie Harrison

 

 

 

 

 

 

 

 

 

Charlie Harrison

 

 

 

 

Company Secretary

 

 

 

Dated: October 17, 2018


INDEX TO EXHIBITS

 

 

 

Item

 

 

 

 

 

99.1

 

Press release of Mesoblast Ltd, dated October 12, 2018.

99.2

 

Appendix 3B of Mesoblast Ltd, dated October 12, 2018.

 

 

 

 

 

 

meso-ex991_6.htm

Exhibit 99.1

 

 

MESOBLAST AND TASLY PHARMACEUTICAL GROUP COMPLETE TRANSACTION FOR STRATEGIC CARDIOVASCULAR PARTNERSHIP IN CHINA 

 

New York, USA, and Melbourne, Australia; October 12, 2018:  Mesoblast Limited (ASX: MSB; Nasdaq: MESO) today announced completion of the transaction with Tasly Pharmaceutical Group to establish a strategic partnership in China for Mesoblast’s allogeneic mesenchymal precursor cell (MPC) product candidates MPC-150-IM for heart failure and MPC-25-IC for heart attacks.

 

Mesoblast has received US$40 million (AUD$57 million) from Tasly, comprising an upfront technology access fee of US$20 million and an equity purchase of US$20 million for which Mesoblast Limited has issued 14,464,259 fully paid ordinary shares to Tasly.

 

As consideration, Tasly has received exclusive rights and will fund all development, manufacturing and commercialization activities in China for MPC-150-IM for the treatment and prevention of chronic heart failure and MPC-25-IC for the prevention and treatment of acute myocardial infarction. Mesoblast will receive US$25 million on achievement of product regulatory approvals in China, double-digit escalating royalties on net product sales, and six additional escalating milestone payments upon the product candidates reaching certain sales thresholds.

 

Mesoblast and Tasly will establish a joint steering committee, with equal representation from both parties, to oversee, review and co-ordinate the development, manufacturing and commercialization activities for the cardiovascular product candidates in China. The parties, through the joint steering committee, plan to expedite development and commercialization of these cardiovascular product candidates by leveraging each other’s clinical trial results in China, and the United States and other major jurisdictions respectively to support their respective regulatory submissions for MPC-150-IM and MPC-25-IC.

 

Chairman of Tasly Pharmaceutical Group Mr Yan Kaijing said: "We believe Mesoblast’s cellular medicine technology platform is poised to transform cardiovascular care in China. This is why Tasly has made this strategic investment and long-term partnership with the premier global cellular medicine company.”

 

Mesoblast Chief Executive Dr Silviu Itescu stated: “We are very excited to be partnering with Tasly, one of the largest pharmaceutical companies in China, the world’s fastest growing biopharmaceutical and healthcare market.”  

About Tasly Pharmaceutical Group

Tasly Pharmaceutical Group (SHA: 600535) is one of the largest pharmaceutical companies in China with more than 20 years of operational history. Its business focuses on R&D, manufacturing and commercialization of innovative modern traditional Chinese medicine, biologics and chemical drugs in the

 

Mesoblast Limited
ABN 68 109 431 870

 

www.mesoblast.com

Corporate Headquarters

Level 38

55 Collins Street

Melbourne 3000

Victoria Australia

 

T +61 3 9639 6036

F +61 3 9639 6030

United States Operations

505 Fifth Avenue

Third Floor

New York, NY 10017

USA

 

T +1 212 880 2060

F +1 212 880 2061

Asia

20 Biopolis Way

#05-01 Centros

Biopreneur 3

SINGAPORE 138668

 

T +65 6570 0635

F +65 6570 0176

 

 

 

 

 

 

 

 

 

 

 


 

therapeutic areas of cardiology, metabolism and oncology. Tasly has the only marketed biological product for cardiovascular diseases approved in China. It has one of the largest pharmaceutical sales and marketing teams, including 809 offices established in 29 regions covering all the main therapeutic areas, and a vast distribution network across approximately 20,000 hospitals in China. At 2017, its total annual revenues exceeded US$2.5 billion.

 

About Mesoblast

Mesoblast Limited (ASX: MSB; Nasdaq: MESO) is a world leader in developing allogeneic (off-the-shelf) cellular medicines. The Company has leveraged its proprietary technology platform to establish a broad portfolio of late-stage product candidates with three product candidates in Phase 3 trials – acute graft versus host disease, chronic heart failure and chronic low back pain due to degenerative disc disease. Through a proprietary process, Mesoblast selects rare mesenchymal lineage precursor and stem cells from the bone marrow of healthy adults and creates master cell banks, which can be industrially expanded to produce thousands of doses from each donor that meet stringent release criteria, have lot to lot consistency, and can be used off-the-shelf without the need for tissue matching. Mesoblast has facilities in Melbourne, New York, Singapore and Texas and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). www.mesoblast.com

 

Forward-Looking Statements

This announcement includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other applicable federal securities laws. Forward- looking statements include, but are not limited to, statements about: the potential benefits of this alliance and the parties’ ability to maintain the alliance; the parties’ ability to advance product candidates into, enroll and successfully complete, clinical studies, advance their manufacturing capabilities, and obtain regulatory filings and approvals. There are many uncertainties and risks that may cause our actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.

 

For further information, please contact:

 

Julie Meldrum

Schond Greenway

Corporate Communications

Investor Relations

Mesoblast

Mesoblast

T: +61 3 9639 6036

T: +1 212 880 2060

E: [email protected]

E: [email protected]

 

 

 

Mesoblast Limited
ABN 68 109 431 870

 

www.mesoblast.com

Corporate Headquarters

Level 38

55 Collins Street

Melbourne 3000

Victoria Australia

 

T +61 3 9639 6036

F +61 3 9639 6030

United States Operations

505 Fifth Avenue

Third Floor

New York, NY 10017

USA

 

T +1 212 880 2060

F +1 212 880 2061

Asia

20 Biopolis Way

#05-01 Centros

Biopreneur 3

SINGAPORE 138668

 

T +65 6570 0635

F +65 6570 0176

 

 

 

 

 

 

 

 

 

 

 

 

 

meso-ex992_7.htm

Exhibit 99.2

New Issue Announcement

Rule 2.7, 3.10.3, 3.10.4, 3.10.5

Appendix 3B

 

New issue announcement,

application for quotation of additional securities

and agreement

 

Information or documents not available now must be given to ASX as soon as available.  Information and documents given to ASX become ASX’s property and may be made public.

Introduced 01/07/96  Origin: Appendix 5  Amended 01/07/98, 01/09/99, 01/07/00, 30/09/01, 11/03/02, 01/01/03, 24/10/05, 01/08/12, 04/03/13

 

 

Name of entity

MESOBLAST LTD

 

ABN

68 109 431 870

 

We (the entity) give ASX the following information.

 

 

Part 1 ‑ All issues

You must complete the relevant sections (attach sheets if there is not enough space).

 

1

+Class of +securities issued or to be issued

Ordinary shares.

 

 

 

2

Number of +securities issued or to be issued (if known) or maximum number which may be issued

14,726,259 ordinary shares.

 

 

 

3

Principal terms of the +securities (e.g. if options, exercise price and expiry date; if partly paid +securities, the amount outstanding and due dates for payment; if +convertible securities, the conversion price and dates for conversion)

14,726,259 ordinary shares (fully paid) as per the company’s constitution. Of this amount, 14,464,259 shares are to be held in voluntary escrow until 12 October 2019.

 

4

Do the +securities rank equally in all respects from the +issue date with an existing +class of quoted +securities?

 

If the additional +securities do not rank equally, please state:

•  the date from which they do

•  the extent to which they participate for the next dividend, (in the case of a trust, distribution) or interest payment

•  the extent to which they do not rank equally, other than in relation to the next dividend, distribution or interest payment

Yes

 

 

 

+ See chapter 19 for defined terms.

 

04/03/2013Appendix 3B Page 1


Exhibit 99.2

New Issue Announcement

 

 

 

5

Issue price or consideration

 

14,464,259 ordinary shares issued for consideration of US$20,000,000.

 

50,000 ordinary shares issued upon the exercise of options in accordance with the Company’s Employee Share Option Plan for consideration of A$65,500.

 

212,000 ordinary shares issued upon the exercise of options in accordance with the Company’s Employee Share Option Plan for consideration of A$252,280.

 

 

 

6

Purpose of the issue

(If issued as consideration for the acquisition of assets, clearly identify those assets)

14,464,259 ordinary shares issued to the Tasly Pharmaceutical Group in connection with the closing of the strategic alliance for the development, manufacture and commercialization in China of Mesoblast’s allogeneic mesenchymal precursor cell product candidates MPC-150-IM for the treatment or prevention of chronic heart failure and MPC-25-IC for the treatment or prevention of acute myocardial infarction, as per the ASX announcement on 17 July 2018.

 

262,000 ordinary shares (fully paid) issued upon the exercise of options in accordance with the Company’s Employee Share Option Plan.

 

 

 

6a

Is the entity an +eligible entity that has obtained security holder approval under rule 7.1A?

 

If Yes, complete sections 6b – 6h in relation to the +securities the subject of this Appendix 3B, and comply with section 6i

No

 

 

 

6b

The date the security holder resolution under rule 7.1A was passed

Not applicable

 

 

 

6c

Number of +securities issued without security holder approval under rule 7.1

Not applicable

 

 

 

6d

Number of +securities issued with security holder approval under rule 7.1A

Not applicable

 

 

 

6e

Number of +securities issued with security holder approval under rule 7.3, or another specific security holder approval (specify date of meeting)

Not applicable

 

 

 

6f

Number of +securities issued under an exception in rule 7.2

Not applicable

 

 

 

 

+ See chapter 19 for defined terms.

 

04/03/2013Appendix 3B Page 2


Exhibit 99.2

New Issue Announcement

6g

If +securities issued under rule 7.1A, was issue price at least 75% of 15 day VWAP as calculated under rule 7.1A.3?  Include the +issue date and both values.  Include the source of the VWAP calculation.

Not applicable

 

 

 

6h

If +securities were issued under rule 7.1A for non-cash consideration, state date on which valuation of consideration was released to ASX Market Announcements

Not applicable

 

 

 

6i

Calculate the entity’s remaining issue capacity under rule 7.1 and rule 7.1A – complete Annexure 1 and release to ASX Market Announcements

Not applicable

 

 

 

7

+Issue dates

 

Note: The issue date may be prescribed by ASX (refer to the definition of issue date in rule 19.12).  For example, the issue date for a pro rata entitlement issue must comply with the applicable timetable in Appendix 7A.

 

Cross reference: item 33 of Appendix 3B.

Date
Registered

12 October 2018

28 September 2018

20 July 2018

 

Total

Number of ordinary
shares issued
14,464,259

212,000

50,000

 

14,726,259

 

 

 

 

 

 

Number

+Class

8

Number and +class of all +securities quoted on ASX (including the +securities in section 2 if applicable)

 

497,365,913

 

Ordinary shares

 

 

 

 

 

 

 

 

Number

+Class

9

Number and +class of all +securities not quoted on ASX (including the +securities in section 2 if applicable)

23,029,000 (688,334 options have been cancelled since last Appendix 3B)

 

Unquoted options

 

 

 

 

 

 

1,500,000

Incentive rights

 

 

 

10

Dividend policy (in the case of a trust, distribution policy) on the increased capital (interests)

All ordinary shares rank equally and participate in the right to dividends equally.

 

 

+ See chapter 19 for defined terms.

 

04/03/2013Appendix 3B Page 3


Exhibit 99.2

New Issue Announcement

Part 2 ‑ Pro rata issue

 

11

Is security holder approval required?

Not applicable

 

 

 

12

Is the issue renounceable or non-renounceable?

Not applicable

 

 

 

13

Ratio in which the +securities will be offered

Not applicable

 

 

 

14

+Class of +securities to which the offer relates

Not applicable

 

 

 

15

+Record date to determine entitlements

Not applicable

 

 

 

16

Will holdings on different registers (or subregisters) be aggregated for calculating entitlements?

Not applicable

 

 

 

17

Policy for deciding entitlements in relation to fractions

Not applicable

 

 

 

18

Names of countries in which the entity has security holders who will not be sent new offer documents

 

Note: Security holders must be told how their entitlements are to be dealt with.

 

Cross reference: rule 7.7.

Not applicable

 

 

 

19

Closing date for receipt of acceptances or renunciations

Not applicable

 

 

 

20

Names of any underwriters

Not applicable

 

 

 

21

Amount of any underwriting fee or commission

Not applicable

 

 

 

22

Names of any brokers to the issue

Not applicable

 

 

 

23

Fee or commission payable to the broker to the issue

Not applicable

 

 

 

24

Amount of any handling fee payable to brokers who lodge acceptances or renunciations on behalf of security holders

Not applicable

 

 

 

25

If the issue is contingent on security holders’ approval, the date of the meeting

Not applicable

 

 

 

26

Date entitlement and acceptance form and offer documents will be sent to persons entitled

Not applicable

 

 

 

 

+ See chapter 19 for defined terms.

 

04/03/2013Appendix 3B Page 4


Exhibit 99.2

New Issue Announcement

27

If the entity has issued options, and the

terms entitle option holders to participate on exercise, the date on which notices will be sent to option holders

Not applicable

 

 

 

28

Date rights trading will begin (if applicable)

Not applicable

 

 

 

29

Date rights trading will end (if applicable)

Not applicable

 

 

 

30

How do security holders sell their entitlements in full through a broker?

Not applicable

 

 

 

31

How do security holders sell part of their entitlements through a broker and accept for the balance?

Not applicable

 

32

How do security holders dispose of their entitlements (except by sale through a broker)?

Not applicable

 

 

 

33

+Issue date

Not applicable

 

Part 3 ‑ Quotation of securities

You need only complete this section if you are applying for quotation of securities

 

34

Type of +securities

(tick one)

 

(a)

+Securities described in Part 1

 

 

 

 

(b)

All other +securities

 

Example: restricted securities at the end of the escrowed period, partly paid securities that become fully paid, employee incentive share securities when restriction ends, securities issued on expiry or conversion of convertible securities


 

+ See chapter 19 for defined terms.

 

04/03/2013Appendix 3B Page 5


Exhibit 99.2

New Issue Announcement

Entities that have ticked box 34(a)

 

Additional securities forming a new class of securities

 

Tick to indicate you are providing the information or documents

 

35

If the +securities are +equity securities, the names of the 20 largest holders of the additional +securities, and the number and percentage of additional +securities held by those holders

 

 

 

36

If the +securities are +equity securities, a distribution schedule of the additional +securities setting out the number of holders in the categories

1 - 1,000

1,001 - 5,000

5,001 - 10,000

10,001 - 100,000

100,001 and over

 

 

 

37

A copy of any trust deed for the additional +securities

 

Entities that have ticked box 34(b)

 

38

Number of +securities for which +quotation is sought

Not applicable

 

 

 

39

+Class of +securities for which quotation is sought

Not applicable

 

 

 

40

Do the +securities rank equally in all respects from the +issue date with an existing +class of quoted +securities?

 

If the additional +securities do not rank equally, please state:

•  the date from which they do

•  the extent to which they participate for the next dividend, (in the case of a trust, distribution) or interest payment

•  the extent to which they do not rank equally, other than in relation to the next dividend, distribution or interest payment

Not applicable

 

 

 

41

Reason for request for quotation now

Example: In the case of restricted securities, end of restriction period

 

(if issued upon conversion of another +security, clearly identify that other +security)

Not applicable

 

 

 

 

 

 

 

 

+ See chapter 19 for defined terms.

 

04/03/2013Appendix 3B Page 6


Exhibit 99.2

New Issue Announcement

 

 

Number

+Class

42

Number and +class of all +securities quoted on ASX (including the +securities in clause 38)

Not applicable

Not applicable


 

+ See chapter 19 for defined terms.

 

04/03/2013Appendix 3B Page 7


Exhibit 99.2

New Issue Announcement

Quotation agreement

 

1

+Quotation of our additional +securities is in ASX’s absolute discretion.  ASX may quote the +securities on any conditions it decides.  

 

2

We warrant the following to ASX.

 

 

The issue of the +securities to be quoted complies with the law and is not for an illegal purpose.

 

 

There is no reason why those +securities should not be granted +quotation.

 

 

An offer of the +securities for sale within 12 months after their issue will not require disclosure under section 707(3) or section 1012C(6) of the Corporations Act.

Note: An entity may need to obtain appropriate warranties from subscribers for the securities in order to be able to give this warranty

 

Section 724 or section 1016E of the Corporations Act does not apply to any applications received by us in relation to any +securities to be quoted and that no-one has any right to return any +securities to be quoted under sections 737, 738 or 1016F of the Corporations Act at the time that we request that the +securities be quoted.

 

 

If we are a trust, we warrant that no person has the right to return the +securities to be quoted under section 1019B of the Corporations Act at the time that we request that the +securities be quoted.

 

3

We will indemnify ASX to the fullest extent permitted by law in respect of any claim, action or expense arising from or connected with any breach of the warranties in this agreement.

 

4

We give ASX the information and documents required by this form.  If any information or document is not available now, we will give it to ASX before +quotation of the +securities begins.  We acknowledge that ASX is relying on the information and documents.  We warrant that they are (will be) true and complete.

 

Sign here:

Date: 12 October 2018

Company secretary

 

Print name:

Charlie Harrison

 

== == == == ==

 

 

 

 

 

 

 

 

 

 

+ See chapter 19 for defined terms.

 

04/03/2013Appendix 3B Page 8


Exhibit 99.2

New Issue Announcement

Appendix 3B – Annexure 1

 

Calculation of placement capacity under rule 7.1 and rule 7.1A for eligible entities

Introduced 01/08/12  Amended 04/03/13

 

Part 1

 

Rule 7.1 – Issues exceeding 15% of capital

Step 1: Calculate “A”, the base figure from which the placement capacity is calculated

Insert number of fully paid +ordinary securities on issue 12 months before the +issue date or date of agreement to issue

470,601,826

Add the following:

•Number of fully paid +ordinary securities issued in that 12 month period under an exception in rule 7.2

•Number of fully paid +ordinary securities issued in that 12 month period with shareholder approval

•Number of partly paid +ordinary securities that became fully paid in that 12 month period

Note:

•Include only ordinary securities here – other classes of equity securities cannot be added

•Include here (if applicable) the securities the subject of the Appendix 3B to which this form is annexed

•It may be useful to set out issues of securities on different dates as separate line items

 

15 December 2017: 255,912 (exercise of options)

6 March 2018: 25,000 (exercise of options)

6 March 2018: 8,333 (exercise of options)

20 July 2018: 50,000 (exercise of options)

28 September 2018: 212,000 (exercise of options)

 

 

Subtract the number of fully paid +ordinary securities cancelled during that 12 month period

 

“A”

471,153,071

 

 


Step 2: Calculate 15% of “A”

“B”

0.15

[Note: this value cannot be changed]

 

+ See chapter 19 for defined terms.

 

04/03/2013Appendix 3B Page 9


Exhibit 99.2

New Issue Announcement

Multiply “A” by 0.15

70,672,961

Step 3: Calculate “C”, the amount of placement capacity under rule 7.1 that has already been used

Insert number of +equity securities issued or agreed to be issued in that 12 month period not counting those issued:

•Under an exception in rule 7.2

•Under rule 7.1A

•With security holder approval under rule 7.1 or rule 7.4

Note:

•This applies to equity securities, unless specifically excluded – not just ordinary securities

•Include here (if applicable) the securities the subject of the Appendix 3B to which this form is annexed

•It may be useful to set out issues of securities on different dates as separate line items

 

19 January 2018: 1,500,000 incentive rights

19 January 2018: 2,381,150 ordinary shares

15 May 2018: 892,857 ordinary shares

10 July 2018: 8,474,576 ordinary shares

12 October 2018: 14,464,259 ordinary shares

 

 

“C”

27,712,842

Step 4: Subtract “C” from [“A” x “B”] to calculate remaining placement capacity under rule 7.1

“A” x 0.15

Note: number must be same as shown in Step 2

70,672,961

Subtract “C”

Note: number must be same as shown in Step 3

27,712,842

Total [“A” x 0.15] – “C”

 

42,960,119

[Note: this is the remaining placement capacity under rule 7.1]

 

 

 

+ See chapter 19 for defined terms.

 

04/03/2013Appendix 3B Page 10


 

Part 2

 

Rule 7.1A – Additional placement capacity for eligible entities

Step 1: Calculate “A”, the base figure from which the placement capacity is calculated

“A”

Note: number must be same as shown in Step 1 of Part 1

Not applicable

Step 2: Calculate 10% of “A”

“D”

0.10

Note: this value cannot be changed

Multiply “A” by 0.10

Not applicable

Step 3: Calculate “E”, the amount of placement capacity under rule 7.1A that has already been used

Insert number of +equity securities issued or agreed to be issued in that 12 month period under rule 7.1A

Notes:

•This applies to equity securities – not just ordinary securities

•Include here – if applicable – the securities the subject of the Appendix 3B to which this form is annexed

•Do not include equity securities issued under rule 7.1 (they must be dealt with in Part 1), or for which specific security holder approval has been obtained

•It may be useful to set out issues of securities on different dates as separate line items

Not applicable

“E”

Not applicable


 

+ See chapter 19 for defined terms.

 

 

 

Appendix 3B Page 11

04/03/2013

 


 

Step 4: Subtract “E” from [“A” x “D”] to calculate remaining placement capacity under rule 7.1A

“A” x 0.10

Note: number must be same as shown in Step 2

Not applicable

Subtract “E”

Note: number must be same as shown in Step 3

Not applicable

Total [“A” x 0.10] – “E”

Not applicable

Note: this is the remaining placement capacity under rule 7.1A

 

 

 

 

+ See chapter 19 for defined terms.

 

 

 

Appendix 3B Page 12

04/03/2013

 


Copyright © 2015 Mesoblast Inc.