UNITED STATES |
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 2021
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 14, 2021, Mesoblast Limited filed with the Australian Securities Exchange a new issue announcement, notification of issue, conversion or payment up of equity securities (Appendix 3G) which is attached hereto as Exhibit 99.1, and is incorporated herein by reference.
On October 14, 2021, Mesoblast Limited filed with the Australian Securities Exchange a new issue announcement, notification of cessation of securities (Appendix 3H) which is attached hereto as Exhibit 99.2, and is incorporated herein by reference.
On October 18, 2021, Mesoblast Limited filed with the Australian Securities Exchange a new release announcement, which is attached hereto as Exhibit 99.3, 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.
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Mesoblast Limited |
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/s/ Niva Sivakumar |
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Niva Sivakumar |
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Company Secretary
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Dated: October 19, 2021
INDEX TO EXHIBITS
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Item |
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99.1 |
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Appendix 3G of Mesoblast Ltd, dated October 14, 2021. |
99.2 |
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Appendix 3H of Mesoblast Ltd, dated October 14, 2021. |
99.3 |
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Press release of Mesoblast Ltd, dated October 18, 2021. |
This appendix is available as an online form Appendix 99.1
Only use this form if the online version is not available+Rule 3.10.3A, 3.10.3B, 3.10.3C, 3.10.3D
Appendix 3G
Notification of issue, conversion or payment up of unquoted equity +securities
Note: this form is also used to notify ASX where quoted options have been exercised or other quoted convertible securities have been converted and the securities received as a result of the exercise or conversion either are already quoted on ASX or are not intended to be quoted on ASX.
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.
If you are an entity incorporated outside Australia and you are issuing a new class of +securities other than CDIs, you will need to obtain and provide an International Securities Identification Number (ISIN) for that class. Further information on the requirement for the notification of an ISIN is available from the Create Online Forms page. ASX is unable to create the new ISIN for non-Australian issuers.
*Denotes minimum information required for first lodgement of this form, with exceptions provided in specific notes for certain questions. The balance of the information, where applicable, must be provided as soon as reasonably practicable by the entity.
Part 1 – Entity and announcement details
Question no |
Question |
Answer |
1.1 |
*Name of entity We (the entity here named) give notice of the issue, conversion or payment up of the following unquoted +securities. |
MESOBLAST LTD |
1.2 |
*Registration type and number Please supply your ABN, ARSN, ARBN, ACN or another registration type and number (if you supply another registration type, please specify both the type of registration and the registration number). |
ABN 68 109 431 870 |
1.3 |
*ASX issuer code |
MSB |
1.4 |
*This announcement is Tick whichever is applicable. |
☒A new announcement ☐An update/amendment to a previous announcement ☐A cancellation of a previous announcement |
1.4a |
*Reason for update Mandatory only if “Update” ticked in Q1.4 above. A reason must be provided for an update. |
N/A |
1.4b |
*Date of previous announcement to this update Mandatory only if “Update” ticked in Q1.4 above. |
N/A |
1.4c |
*Reason for cancellation Mandatory only if “Cancellation” ticked in Q1.4 above. |
N/A |
1.4d |
*Date of previous announcement to this cancellation Mandatory only if “Cancellation” ticked in Q1.4 above. |
N/A |
1.5 |
*Date of this announcement |
14 October 2021 |
+ See chapter 19 for defined terms
5 June 2021Page 1
This appendix is available as an online formAppendix 3G
Notification of issue, conversion or
payment up of unquoted equity +securities
Part 2 – Type of issue
Question No. |
Question |
Answer |
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2.1 |
*The +securities the subject of this notification are: Select whichever item is applicable. If you wish to notify ASX of different events involving unquoted securities, please complete a separate Appendix 3G for each event. |
☐+Securities issued as part of a transaction or transactions previously announced to the market in an Appendix 3B that are not quoted, and are not intended to be quoted, on ASX ☐+Securities issued under a +dividend or distribution plan that are not quoted, and are not intended to be quoted, on ASX ☒Unquoted options that have been exercised or other unquoted +convertible securities that have been converted ☐Quoted options that have been exercised or other quoted +convertible securities that have been converted where the +securities received as a result of the exercise or conversion either are already quoted on ASX or are not intended to be quoted on ASX ☐Unquoted partly paid +securities upon which a call or instalment has been paid ☐+Securities issued under an +employee incentive scheme that are subject to a restriction on transfer and are not being quoted on ASX until the restriction ends ☐+Other securities issued under an +employee incentive scheme that are not intended to be quoted on ASX ☐Other [please specify] If you have selected ‘other’ please explain the circumstances here:
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2.1a |
*Date the +securities the subject of this notification were issued Answer this question if your response to Q2.1 is anything other than “Unquoted partly paid securities upon which a call or instalment has been paid”. |
9 September 2021 |
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2.2a.1 |
*Date of Appendix 3B notifying the market of the proposed issue of +securities the subject of this notification Answer this question if your response to Q2.1 is “Securities issued as part of a transaction or transactions previously announced to the market in an Appendix 3B that are not quoted, and are not intended to be quoted, on ASX.” |
N/A |
+ See chapter 19 for defined terms
5 June 2021Page 2
This appendix is available as an online formAppendix 3G
Notification of issue, conversion or
payment up of unquoted equity +securities
2.2a.2 |
*Are there any further issues of +securities yet to take place to complete the transaction(s) referred to in the Appendix 3B? Answer this question if your response to Q2.1 is “Securities issued as part of a transaction or transactions previously announced to the market in an Appendix 3B that are not quoted, and are not intended to be quoted, on ASX”. |
N/A |
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2.2a.2.1 |
*Please provide details of the further issues of +securities yet to take place to complete the transaction(s) referred to in the Appendix 3B Answer this question if your response to Q2.1 is “Securities issued as part of a transaction or transactions previously announced to the market in an Appendix 3B that are not quoted, and are not intended to be quoted, on ASX” and your response to Q2.2a.2 is “Yes”. Please provide details of the proposed dates and number of securities for the further issues. |
N/A |
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2.2b.1 |
Date of Appendix 3A.1 lodged with ASX in relation to the underlying +dividend or distribution Answer this question if your response to Q2.1 is “Being issued under a dividend or distribution plan that are not quoted, and are not intended to be quoted, on ASX”. |
N/A |
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2.2c.1 |
Please state the number and type of options that were exercised or other +convertible securities that were converted (including their ASX security code if available): Answer this question if your response to Q2.1 is “Unquoted options that have been exercised or other unquoted convertible securities that have been converted” or “Quoted options that have been exercised or other quoted convertible securities that have been converted where the securities received as a result of the exercise or conversion either are already quoted on ASX or are not intended to be quoted on ASX”. |
6,667 |
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2.2c.2 |
And the date the options were exercised or other +convertible securities were converted: Answer this question if your response to Q2.1 is “Unquoted options that have been exercised or other unquoted convertible securities that have been converted” or “Quoted options that have been exercised or other quoted convertible securities that have been converted where the securities received as a result of the exercise or conversion either are already quoted on ASX or are not intended to be quoted on ASX”. Note: If this occurred over a range of dates, enter the date the last of the options was exercised or convertible securities was converted. |
9 September 2021 |
+ See chapter 19 for defined terms
5 June 2021Page 3
This appendix is available as an online formAppendix 3G
Notification of issue, conversion or
payment up of unquoted equity +securities
2.2c.3 |
Is this all of the options or other +convertible securities on issue of that type (ie have all of those options now been exercised or have all of those convertible securities now been converted)? Answer this question if your response to Q2.1 is ““Unquoted options that have been exercised or other unquoted convertible securities that have been converted” or “Quoted options that have been exercised or other quoted convertible securities that have been converted where the securities received as a result of the exercise or conversion either are already quoted on ASX or are not intended to be quoted on ASX”. |
No Note: If you have answered “No”, consider whether you need to lodge an Appendix 3H with ASX notifying ASX of the cessation of some or all of the remaining options or other convertible securities under Listing Rule 3.10.E. This may the case, for example, if options have lapsed because they have passed their expiry date without being exercised, or convertible debt securities have been repaid or redeemed without being converted. |
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2.2c.4 |
The right of the holder of the options or other +convertible securities to receive the +underlying securities is being satisfied by: Answer this question if your response to Q2.1 is “Unquoted options that have been exercised or other unquoted convertible securities that have been converted” or “Quoted options that have been exercised or other quoted convertible securities that have been converted where the securities received as a result of the exercise or conversion either are already quoted on ASX or are not intended to be quoted on ASX”. |
☐An issue of new +securities ☒A transfer of existing +securities ☐A reclassification of the +convertible securities as securities in the same class as the +underlying securities |
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2.2c.5 |
The underlying securities being received by the holder are: Answer this question if your response to Q2.1 is “Unquoted options that have been exercised or other unquoted convertible securities that have been converted”. |
☒Already quoted by ASX ☐Intended to be, but are not yet, quoted by ASX ☐Are not, and are not intended to be, quoted by ASX |
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2.2c.6 |
The underlying securities being received by the holder are: Answer this question if your response to Q2.1 is “Quoted options that have been exercised or other quoted convertible securities that have been converted where the securities received as a result of the exercise or conversion either are already quoted on ASX or are not intended to be quoted on ASX”. |
☐Already quoted by ASX ☐Are not, and are not intended to be, quoted by ASX
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2.2c.7 |
*Were the options being exercised or other +convertible securities being converted issued under an +employee incentive scheme? Answer this question if your response to Q2.1 is “Unquoted options that have been exercised or other unquoted convertible securities that have been converted” or “Quoted options that have been exercised or other quoted convertible securities that have been converted where the securities received as a result of the exercise or conversion either are already quoted on ASX or are not intended to be quoted on ASX”. |
Yes |
+ See chapter 19 for defined terms
5 June 2021Page 4
This appendix is available as an online formAppendix 3G
Notification of issue, conversion or
payment up of unquoted equity +securities
2.2c.8 |
*Are any of the options being exercised or other +convertible securities being converted held by +key management personnel (KMP) or an +associate? Answer this question if your response to Q2.1 is “Unquoted options that have been exercised or other unquoted convertible securities that have been converted” or “Quoted options that have been exercised or other quoted convertible securities that have been converted where the securities received as a result of the exercise or conversion either are already quoted on ASX or are not intended to be quoted on ASX”.” and your response to Q2.2c.7 is “Yes”. |
No |
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2.2c.8.a |
*Provide details of the KMP or associates who are exercising options or converting convertible securities. Answer this question if your response to Q2.1 is “Unquoted options that have been exercised or other unquoted convertible securities that have been converted” or “Quoted options that have been exercised or other quoted convertible securities that have been converted where the securities received as a result of the exercise or conversion either are already quoted on ASX or are not intended to be quoted on ASX”, your response to Q2.2c.7 is “Yes” and your response to Q2.2c.8 is “Yes”. Repeat the detail in the table below for each KMP involved. If the options or other convertible securities are held by the KMP, repeat the name of the KMP or insert “Same” in “Name of registered holder”. If the options or other convertible securities are held by an associate of a KMP, insert the name of the associate in “Name of registered holder”.
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Name of KMP |
Name of registered holder |
Number of options being exercised or other +convertible securities being converted |
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2.2d.1 |
Please state the number and type of partly paid +securities upon which a call or instalment has been paid (including their ASX security code if available)? Answer this question if your response to Q2.1 is “Unquoted partly paid securities upon which a call or instalment has been paid”. |
N/A |
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2.2d.2 |
And the date upon which the call or instalment was paid: Answer this question if your response to Q2.1 is “Unquoted partly paid securities upon which a call or instalment has been paid”. Note: If this occurred over a range of dates, enter the date the last of the payments was made. |
N/A |
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2.2d.3 |
Has the call or instalment been paid on all of the partly paid +securities in question? Answer this question if your response to Q2.1 is “Unquoted partly paid securities upon which a call or instalment has been paid”. |
N/A Note: If you have answered “No”, consider whether you need to lodge an Appendix 3H with ASX notifying ASX of the cessation of some or all of the remaining partly paid securities under Listing Rule 3.10.E. This may the case, for example, if partly paid securities that have not had the call paid by the due date will be cancelled. If you are an NL company, consider also whether you have notification obligations in relation to any forfeiture of the partly paid securities not paid up under Listing Rule 3.12. |
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2.2d.4 |
Are the securities on which the call or instalment was paid now fully paid? |
N/A |
+ See chapter 19 for defined terms
5 June 2021Page 5
This appendix is available as an online formAppendix 3G
Notification of issue, conversion or
payment up of unquoted equity +securities
2.2e.1 |
Please state the number and type of +securities (including their ASX security code) issued under the +employee incentive scheme Answer this question if your response to Q2.1 is “Securities issued under an employee incentive scheme that are subject to a restriction on transfer and are not being quoted on ASX until the restriction ends” or “Other securities issued under an employee incentive scheme that are not intended to be quoted on ASX”. |
N/A |
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2.2e.2 |
*Please attach a document or provide details of a URL link for a document lodged with ASX detailing the terms of the +employee incentive scheme or a summary of the terms. Answer this question if your response to Q2.1 is “Securities issued under an employee incentive scheme that are subject to a restriction on transfer and are not being quoted on ASX until the restriction ends” or “Other securities issued under an employee incentive scheme that are not intended to be quoted on ASX”. |
N/A |
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2.2e.3 |
*Were any of the +securities issued to +key management personnel (KMP) or an +associate Answer this question if your response to Q2.1 is “Securities issued under an employee incentive scheme that are subject to a restriction on transfer and are not being quoted on ASX until the restriction ends” or “Other securities issued under an employee incentive scheme that are not intended to be quoted on ASX”. |
N/A |
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2.2e.3.a |
*Provide details of the KMP or +associates being issued +securities. Answer this question if your response to Q2.1 is “Securities issued under an employee incentive scheme that are subject to a restriction on transfer and are not being quoted on ASX until the restriction ends” or “Other securities issued under an employee incentive scheme that are not intended to be quoted on ASX” and your response to Q2.2e.3 is “Yes”. Repeat the detail in the table below for each KMP involved in the issue. If the securities are being issued to the KMP, repeat the name of the KMP or insert “Same” in “Name of registered holder”. If the securities are being issued to an associate of a KMP, insert the name of the associate in “Name of registered holder”.
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Name of KMP |
Name of registered holder |
Number of +securities |
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2.2f.1 |
*Were the +securities issued for a cash consideration? Answer this question if your response to Q2.1 is “Other”. If the securities are being issued for nil cash consideration, answer this question “No”. |
N/A |
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2.2f.1.a |
*In what currency was the cash consideration paid? Answer this question if your response to Q2.1 is “Other” and your response to Q2.2f.1 is “Yes”. For example, if the consideration is being paid in Australian Dollars, state AUD. |
N/A |
+ See chapter 19 for defined terms
5 June 2021Page 6
This appendix is available as an online formAppendix 3G
Notification of issue, conversion or
payment up of unquoted equity +securities
2.2f.1.b |
*What was the issue price per +security Answer this question if your response to Q2.1 is “Other” and your response to Q2.2f.1 is “Yes”, and by reference to the issue currency provided in your response to Q2.2f.1.a. Note: you cannot enter a nil amount here. If the securities are being issued for nil cash consideration, answer Q2.2f.1 as “No” and complete Q2.2f.1.c. |
N/A |
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2.2f.1.c |
Please describe the consideration provided for the +securities Answer this question if your response to Q2.1 is “Other” and your response to Q2.2f.1 is “No”. |
N/A |
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2.2f.2 |
*The purpose(s) for which the entity issued the +securities was: Answer this question if your response to Q2.1 is “Other”. You may select one or more of the items in the list. |
☐To raise additional working capital ☐To fund the retirement of debt ☐To pay for the acquisition of an asset [provide details below] ☐To pay for services rendered ☐Other [provide details below] Additional details:
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2.2f.3 |
Please provide any further information needed to understand the circumstances in which you are notifying the issue of these +securities to ASX, including why the issue of the +securities has not been previously announced to the market in an Appendix 3B You must answer this question if your response to Q2.1 is “Other”. If there is no other information to provide, please answer “Not applicable” or “N/A”. |
N/A |
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2.3a |
*This notification is given in relation to an issue of +securities in a class which is not quoted on ASX and which: Answer this question if your response to Q2.1 is anything other than “Unquoted options that have been exercised or other unquoted convertible securities that have been converted”, “Quoted options that have been exercised or other quoted convertible securities that have been converted where the securities received as a result of the exercise or conversion either are already quoted on ASX or are not intended to be quoted on ASX” or “Unquoted partly paid securities upon which a call or instalment has been paid”. |
☐has an existing ASX security code ("existing class") ☐does not have an existing ASX security code ("new class") |
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2.3b |
*The +securities being issued, transferred or re-classified as a result of the options being exercised or other +convertible securities being converted are: Answer this question if your response to Q2.1 is “Unquoted options that have been exercised or other unquoted convertible securities that have been converted” or “Quoted options that have been exercised or other quoted convertible securities that have been converted where the securities received as a result of the exercise or conversion either are already quoted on ASX or are not intended to be quoted on ASX”. |
☒securities that have already been quoted on ASX ("existing class") ☐in a class which is not quoted on ASX but which has an existing ASX security code ("existing class") ☐in a class which is not quoted on ASX and which does not have an existing ASX security code ("new class") |
+ See chapter 19 for defined terms
5 June 2021Page 7
This appendix is available as an online formAppendix 3G
Notification of issue, conversion or
payment up of unquoted equity +securities
2.3c |
*The call or instalment the subject of this notification is being paid on +securities which are not quoted on ASX and which: Answer this question if your response to Q2.1 is “Unquoted partly paid securities upon which a call or instalment has been paid”. |
☐have an existing ASX security code ("existing class") ☐do not have an existing ASX security code ("new class") |
Part 3A – |
number and type of +securities the subject of this notification (existing or new class) where issue has previously been notified to ASX in an Appendix 3B |
Answer the questions in this Part if your response to Q2.1 is “Securities issued as part of a transaction or transactions previously announced to the market in an Appendix 3B that are not quoted, and are not intended to be quoted, on ASX”.
Question No. |
Question |
Answer |
3A.1 |
*ASX security code & description |
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3A.2 |
*Number of +securities issued/paid up |
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3A.3 |
Any other information the entity wishes to provide about the +securities the subject of this notification |
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Part 3B – |
number and type of +securities the subject of this notification (existing class) where issue has not previously been notified to ASX in an Appendix 3B |
Answer the questions in this part if your response to Q2.1 is anything other than “Securities issued as part of a transaction or transactions previously announced to the market in an Appendix 3B that are not quoted, and are not intended to be quoted, on ASX” and your response to Q2.3a, 2.3b or 2.3c (as applicable) is “existing class”. If your response to Q2.1 is “Unquoted options that have been exercised or other unquoted convertible securities that have been converted” or “Quoted options that have been exercised or other quoted convertible securities that have been converted where the securities received as a result of the exercise or conversion either are already quoted on ASX or are not intended to be quoted on ASX”, the questions in this part relate to the securities issued, transferred or re-classified as a result of the exercise of the options or the conversion of the convertible securities. If your response to Q2.1 is “Unquoted partly paid securities upon which a call or instalment has been paid”, the questions in this part relate to the securities arising from that payment. Otherwise, the questions in this part relate to the securities issued by the entity which are the subject of this notification and which are described in the response to Q2.1.
Question No. |
Question |
Answer |
3B.1 |
*ASX security code & description |
MSB |
3B.2 |
*Number of +securities issued/transferred/reclassified/paid up |
6,667 fully paid ordinary shares |
+ See chapter 19 for defined terms
5 June 2021Page 8
This appendix is available as an online formAppendix 3G
Notification of issue, conversion or
payment up of unquoted equity +securities
3B.3a |
*Will the +securities rank equally in all respects from their issue date with the existing issued +securities in that class? You do not need to answer this question if your response to Q2.1 is ““Unquoted options that have been exercised or other unquoted convertible securities that have been converted” or “Quoted options that have been exercised or other quoted convertible securities that have been converted where the securities received as a result of the exercise or conversion either are already quoted on ASX or are not intended to be quoted on ASX”, and your response to Q2.2c.4 is “A transfer of existing securities” and your response to Q2.3b is “securities that have already been quoted on ASX”. |
N/A |
3B.3b |
*Is the actual date from which the +securities will rank equally (non-ranking end date) known? You do not need to answer this question if your response to Q2.1 is “Unquoted options that have been exercised or other unquoted convertible securities that have been converted” or “Quoted options that have been exercised or other quoted convertible securities that have been converted where the securities received as a result of the exercise or conversion either are already quoted on ASX or are not intended to be quoted on ASX”, your response to Q2.2c.4 is “A transfer of existing securities” and your response to Q2.3b is “securities that have already been quoted on ASX”. Otherwise answer this question if your response to Q3B.3a is “No”. |
N/A |
3B.3c |
*Provide the actual non-ranking end date You do not need to answer this question if your response to Q2.1 is “Unquoted options that have been exercised or other unquoted convertible securities that have been converted” or “Quoted options that have been exercised or other quoted convertible securities that have been converted where the securities received as a result of the exercise or conversion either are already quoted on ASX or are not intended to be quoted on ASX”, your response to Q2.2c.4 is “A transfer of existing securities” and your response to Q2.3b is “securities that have already been quoted on ASX”. Otherwise answer this question if your response to Q3B.3a is “No” and your response to Q3B.3b is “Yes”. |
N/A |
3B.3d |
*Provide the estimated non-ranking end period You do not need to answer this question if your response to Q2.1 is “Unquoted options that have been exercised or other unquoted convertible securities that have been converted” or “Quoted options that have been exercised or other quoted convertible securities that have been converted where the securities received as a result of the exercise or conversion either are already quoted on ASX or are not intended to be quoted on ASX”, your response to Q2.2c.4 is “A transfer of existing securities” and your response to Q2.3b is “securities that have already been quoted on ASX”. Otherwise answer this question if your response to Q3B.3a is “No” and your response to Q3B.3b is “No”. |
N/A |
+ See chapter 19 for defined terms
5 June 2021Page 9
This appendix is available as an online formAppendix 3G
Notification of issue, conversion or
payment up of unquoted equity +securities
3B.3e |
*Please state the extent to which the +securities do not rank equally: •in relation to the next dividend, distribution or interest payment; or •for any other reason Otherwise answer this question if your response to Q3B.3a is “No”. You do not need to answer this question if your response to Q2.1 is “Unquoted options that have been exercised or other unquoted convertible securities that have been converted” or “Quoted options that have been exercised or other quoted convertible securities that have been converted where the securities received as a result of the exercise or conversion either are already quoted on ASX or are not intended to be quoted on ASX”, your response to Q2.2c.4 is “A transfer of existing securities” and your response to Q2.3b is “securities that have already been quoted on ASX”. For example, the securities may not rank at all, or may rank proportionately based on the percentage of the period in question they have been on issue, for the next dividend, distribution or interest payment; or they may not be entitled to participate in some other event, such as an entitlement issue. |
N/A |
3B.4 |
Any other information the entity wishes to provide about the +securities the subject of this notification |
N/A |
Part 3C – |
number and type of +securities the subject of this notification (new class) |
Answer the questions in this part if your response to Q2.1 is anything other than “Securities issued as part of a transaction or transactions previously announced to the market in an Appendix 3B that are not quoted, and are not intended to be quoted, on ASX” and your response to Q2.3a, 2.3b or 2.3c (as applicable) is “new class”. If your response to Q2.1 is “Unquoted options that have been exercised or other unquoted convertible securities that have been converted” or “Quoted options that have been exercised or other quoted convertible securities that have been converted where the securities received as a result of the exercise or conversion either are already quoted on ASX or are not intended to be quoted on ASX”, the questions in this part relate to the securities being issued, transferred or reclassified as a result of the exercise of the options or the conversion of the convertible securities. If your response to Q2.1 is “Unquoted partly paid securities upon which a call or instalment has been paid”, the questions in this part relate to the call paid or fully paid securities arising from that payment. Otherwise, the questions in this part relate to the securities issued by the entity which are the subject of this notification and which are described in the response to Q2.1.
+ See chapter 19 for defined terms
5 June 2021Page 10
This appendix is available as an online formAppendix 3G
Notification of issue, conversion or
payment up of unquoted equity +securities
Question No. |
Question |
Answer |
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C.1 |
*Security description |
N/A |
|
3C.2 |
*Security type Select one item from the list that best describes the securities the subject of this form. This will determine more detailed questions to be asked about the security later in this section. Select “ordinary fully or partly paid shares/units” for stapled securities or CDIs. For interest rate securities, please select the appropriate choice from either “Convertible debt securities” or “Non-convertible debt securities”. Select “Other” for performance shares/units and performance options/rights or if the selections available in the list do not appropriately describe the security being issued. |
☐Ordinary fully or partly paid shares/units ☐Options ☐+Convertible debt securities ☐Non-convertible +debt securities ☐Redeemable preference shares/units ☐Other |
|
3C.3 |
ISIN code Answer this question if you are an entity incorporated outside Australia and you are issuing a new class of securities other than CDIs. See also the note at the top of this form. |
N/A |
|
3C.4 |
*Number of +securities issued/paid up |
N/A |
|
3C.5a |
*Will all the +securities issued in this class rank equally in all respects from the issue date? |
N/A |
|
3C.5b |
*Is the actual date from which the +securities will rank equally (non-ranking end date) known? Answer this question if your response to Q3C.5a is “No”. |
N/A |
|
3C.5c |
*Provide the actual non-ranking end date Answer this question if your response to Q3C.5a is “No” and your response to Q3C.5b is “Yes”. |
N/A |
|
3C.5d |
*Provide the estimated non-ranking end period Answer this question if your response to Q3C.5a is “No” and your response to Q3C.5b is “No”. |
N/A |
|
3C.5e |
*Please state the extent to which the +securities do not rank equally: •in relation to the next dividend, distribution or interest payment; or •for any other reason Answer this question if your response to Q3C.5a is “No”. For example, the securities may not rank at all, or may rank proportionately based on the percentage of the period in question they have been on issue, for the next dividend, distribution or interest payment; or they may not be entitled to participate in some other event, such as an entitlement issue. |
N/A |
|
3C.6 |
Please attach a document or provide a URL link for a document lodged with ASX setting out the material terms of the +securities being issued You may cross reference a disclosure document, PDS, information memorandum, investor presentation or other announcement with this information provided it has been released to the ASX Market Announcements Platform. |
N/A |
+ See chapter 19 for defined terms
5 June 2021Page 11
This appendix is available as an online formAppendix 3G
Notification of issue, conversion or
payment up of unquoted equity +securities
3C.7 |
*Have you received confirmation from ASX that the terms of the +securities are appropriate and equitable under listing rule 6.1? Answer this question only if you are an ASX Listing. (ASX Foreign Exempt Listings and ASX Debt Listings do not have to answer this question). If your response is “No” and the securities have any unusual terms, you should approach ASX as soon as possible for confirmation under listing rule 6.1 that the terms are appropriate and equitable. |
N/A |
|
3C.8a |
Ordinary fully or partly paid shares/units details Answer the questions in this section if you selected this security type in your response to Question 3B.2. |
||
|
*+Security currency This is the currency in which the face amount of an issue is denominated. It will also typically be the currency in which distributions are declared. |
N/A |
|
|
*Are there CDIs issued over the +securities? |
N/A |
|
|
*CDI ratio Answer this question if you answered “Yes” to the previous question. This is the ratio at which CDIs can be transmuted into the underlying security (e.g. 4:1 means 4 CDIs represent 1 underlying security whereas 1:4 means 1 CDI represents 4 underlying securities). |
N/A |
|
|
*Is it a partly paid class of +security? |
N/A |
|
|
*Paid up amount: unpaid amount Answer this question if answered “Yes” to the previous question. The paid up amount represents the amount of application money and/or calls which have been paid on any security considered ‘partly paid’ The unpaid amount represents the unpaid or yet to be called amount on any security considered ‘partly paid’. The amounts should be provided per the security currency (e.g. if the security currency is AUD, then the paid up and unpaid amount per security in AUD). |
N/A |
|
|
*Is it a stapled +security? This is a security class that comprises a number of ordinary shares and/or ordinary units issued by separate entities that are stapled together for the purposes of trading. |
N/A |
|
3C.8b |
Option details Answer the questions in this section if you selected this security type in your response to Question 3B.2. |
||
|
*+Security currency This is the currency in which the exercise price is payable. |
N/A |
|
|
*Exercise price The price at which each option can be exercised and convert into the underlying security. If there is no exercise price please answer as $0.00. The exercise price should be provided per the security currency (i.e. if the security currency is AUD, the exercise price should be expressed in AUD). |
N/A |
|
|
*Expiry date The date on which the options expire or terminate. |
N/A |
+ See chapter 19 for defined terms
5 June 2021Page 12
This appendix is available as an online formAppendix 3G
Notification of issue, conversion or
payment up of unquoted equity +securities
|
*Details of the number and type of +security (including its ASX security code if the +security is quoted on or recorded by ASX) that will be issued if an option is exercised For example, if the option can be exercised to receive one fully paid ordinary share with ASX security code ABC, please insert “One fully paid ordinary share (ASX:ABC)“. |
N/A |
|
3C.8c |
Details of non-convertible +debt securities, +convertible debt securities, or redeemable preference shares/units Answer the questions in this section if you selected one of these security types in your response to Question 3B.2. Refer to Guidance Note 34 and the “Guide to the Naming Conventions and Security Descriptions for ASX Quoted Debt and Hybrid Securities” for further information on certain terms used in this section |
||
|
*Type of +security Select one item from the list |
☐Simple corporate bond ☐Non-convertible note or bond ☐Convertible note or bond ☐Preference share/unit ☐Capital note ☐Hybrid security ☐Other |
|
|
*+Security currency This is the currency in which the face value of the security is denominated. It will also typically be the currency in which interest or distributions are paid. |
N/A |
|
|
Face value This is the principal amount of each security. The face value should be provided per the security currency (i.e. if security currency is AUD, then the face value per security in AUD). |
N/A |
|
|
*Interest rate type Select one item from the list Select the appropriate interest rate type per the terms of the security. Definitions for each type are provided in the Guide to the Naming Conventions and Security Descriptions for ASX Quoted Debt and Hybrid Securities |
☐Fixed rate ☐Floating rate ☐Indexed rate ☐Variable rate ☐Zero coupon/no interest ☐Other |
|
|
Frequency of coupon/interest payments per year Select one item from the list. |
☐Monthly ☐Quarterly ☐Semi-annual ☐Annual ☐No coupon/interest payments ☐Other |
|
|
First interest payment date A response is not required if you have selected “No coupon/interest payments” in response to the question above on the frequency of coupon/interest payments |
N/A |
|
|
Interest rate per annum Answer this question if the interest rate type is fixed. |
N/A |
+ See chapter 19 for defined terms
5 June 2021Page 13
This appendix is available as an online formAppendix 3G
Notification of issue, conversion or
payment up of unquoted equity +securities
|
*Is the interest rate per annum estimated at this time? Answer this question if the interest rate type is fixed. |
N/A |
|
|
If the interest rate per annum is estimated, then what is the date for this information to be announced to the market (if known) Answer this question if the interest rate type is fixed and your response to the previous question is “Yes”. Answer “Unknown” if the date is not known at this time. |
N/A |
|
|
*Does the interest rate include a reference rate, base rate or market rate (e.g. BBSW or CPI)? Answer this question if the interest rate type is floating or indexed |
N/A |
|
|
*What is the reference rate, base rate or market rate? Answer this question if the interest rate type is floating or indexed and your response to the previous question is “Yes”. |
N/A |
|
|
*Does the interest rate include a margin above the reference rate, base rate or market rate? Answer this question if the interest rate type is floating or indexed. |
N/A |
|
|
*What is the margin above the reference rate, base rate or market rate (expressed as a percent per annum) Answer this question if the interest rate type is floating or indexed and your response to the previous question is “Yes”. |
N/A |
|
|
*S128F of the Income Tax Assessment Act status applicable to the +security Select one item from the list For financial products which are likely to give rise to a payment to which s128F of the Income Tax Assessment Act applies, ASX requests issuers to confirm the s128F status of the security: •“s128F exempt” means interest payments are not taxable to non-residents; •“Not s128F exempt” means interest payments are taxable to non-residents; •“s128F exemption status unknown” means the issuer is unable to advise the status; •“Not applicable” means s128F is not applicable to this security |
☐s128F exempt ☐Not s128F exempt ☐s128F exemption status unknown ☐Not applicable
|
|
|
*Is the +security perpetual (i.e. no maturity date)? |
N/A |
|
|
*Maturity date Answer this question if the security is not perpetual |
N/A |
+ See chapter 19 for defined terms
5 June 2021Page 14
This appendix is available as an online formAppendix 3G
Notification of issue, conversion or
payment up of unquoted equity +securities
|
*Select other features applicable to the +security Up to 4 features can be selected. Further information is available in the Guide to the Naming Conventions and Security Descriptions for ASX Quoted Debt and Hybrid Securities. |
☐Simple ☐Subordinated ☐Secured ☐Converting ☐Convertible ☐Transformable ☐Exchangeable ☐Cumulative ☐Non-Cumulative ☐Redeemable ☐Extendable ☐Reset ☐Step-Down ☐Step-Up ☐Stapled ☐None of the above |
|
|
*Is there a first trigger date on which a right of conversion, redemption, call or put can be exercised (whichever is first)? |
N/A |
|
|
*If yes, what is the first trigger date Answer this question if your response to the previous question is “Yes”. |
N/A |
|
|
Details of the number and type of +security (including its ASX security code if the +security is quoted on ASX) that will be issued if the securities to be quoted are converted, transformed or exchanged Answer this question if the security features include “converting”, “convertible”, “transformable” or “exchangeable”. For example, if the security can be converted into 1,000 fully paid ordinary shares with ASX security code ABC, please insert “1,000 fully paid ordinary shares (ASX:ABC)“. |
N/A |
|
3C.9 |
Any other information the entity wishes to provide about the +securities the subject of this notification |
N/A |
Part 4 –+Securities on issue
Following the issue, conversion or payment up of the +securities the subject of this application, the issued +securities of the entity will comprise: Note: the figures provided in the table below are used to calculate part of the total market capitalisation of the entity published by ASX from time to time. Please make sure you include in the table each class of security issued by the entity. Restricted securities should be included in table 4.2. |
+ See chapter 19 for defined terms
5 June 2021Page 15
This appendix is available as an online formAppendix 3G
Notification of issue, conversion or
payment up of unquoted equity +securities
4.1 |
Quoted +Securities (Total number of each +class of +securities issued and quoted on ASX)
|
|||
|
*ASX security code and description |
*Total number of +securities on issue |
|
|
|
Ordinary shares |
648,696,070 |
|
|
|
|
|
|
|
4.2 |
Unquoted +Securities (Total number of each +class of +securities issued but not quoted on ASX)
|
|||
|
*ASX security code and description |
*Total number of +securities on issue |
|
|
|
Unquoted options
Incentive rights
Warrants |
42,644,134
1,500,000
15,027,327 |
|
|
|
|
|
|
Part 5 – Other Listing Rule requirements
The questions in this Part should only be answered if you are an ASX Listing (ASX Foreign Exempt Listings and ASX Debt Listings do not need to complete this Part) and your response to Q2.1 is:
- |
“Securities issued under a dividend or distribution plan that are not quoted, and are not intended to be quoted, on ASX”; |
- |
“Securities issued under an employee incentive scheme that are subject to a restriction on transfer and are not being quoted on ASX until the restriction ends” or “Other securities issued under an employee incentive scheme that are not intended to be quoted on ASX”; or |
- |
“Other” |
Note that if your response to Q2.1 is “Securities issued as part of a transaction or transactions previously announced to the market in an Appendix 3B that are not quoted, and are not intended to be quoted, on ASX”, it is assumed that you will have provided the information referred to in this Part in the Appendix 3B.
Question No. |
Question |
Answer |
5.1 |
*Were the +securities issued under an exception in Listing Rule 7.2 and therefore the issue did not need any security holder approval under Listing Rule 7.1? |
N/A |
5.1a |
Enter the number of the applicable exception in Listing Rule 7.2 Note this should be a number between 1 and 17. |
N/A |
+ See chapter 19 for defined terms
5 June 2021Page 16
This appendix is available as an online formAppendix 3G
Notification of issue, conversion or
payment up of unquoted equity +securities
5.1a.1 |
*Does the +dividend or distribution plan meet the requirement of listing rule 7.2 exception 4 that it does not impose a limit on participation? Answer this question if your response to Q5.1 is “Yes” and your response to Q5.1a is “4”. Note: Exception 4 only applies where security holders are able to elect to receive all of their dividend or distribution as securities. For example, Exception 4 would not apply in the following circumstances: 1) The entity has specified a dollar limit on the level of participation e.g. security holders can only participate to a maximum value of $x in respect of their entitlement, or 2) The entity has specified a maximum number of securities that can participate in the plan e.g. security holders can only receive securities in lieu of dividend payable for x number of securities. |
N/A |
5.2 |
*Has the entity obtained, or is it obtaining, +security holder approval for the issue under listing rule 7.1? Answer this question if the response to Q5.1 is “No”. |
N/A |
5.2a |
*Date of meeting or proposed meeting to approve the issue under listing rule 7.1 Answer this question if the response to Q5.1 is “No” and the response to Q5.2 is “Yes”. |
N/A |
5.2b |
*Are any of the +securities being issued without +security holder approval using the entity’s 15% placement capacity under listing rule 7.1? Answer this question if the response to Q5.1 is “No” and the response to Q5.2 is “No”. |
N/A |
5.2b.1 |
*How many +securities are being issued without +security holder approval using the entity’s 15% placement capacity under listing rule 7.1? Answer this question if the response to Q5.1 is “No”, the response to Q5.2 is “No” and the response to Q5.2b is “Yes”. If the response to Q5.2b is “Yes”, please complete and separately send by email to your ASX listings adviser a work sheet in the form of Annexure B to Guidance Note 21 confirming the entity has the available capacity under listing rule 7.1 to issue that number of securities. |
N/A |
5.2c |
*Are any of the +securities being issued without +security holder approval using the entity’s additional 10% placement capacity under listing rule 7.1A (if applicable)? Answer this question if the response to Q5.1 is “No” and the response to Q5.2 is “No”. |
N/A |
+ See chapter 19 for defined terms
5 June 2021Page 17
This appendix is available as an online formAppendix 3G
Notification of issue, conversion or
payment up of unquoted equity +securities
5.2c.1 |
*How many +securities are being issued without +security holder approval using the entity’s additional 10% placement capacity under listing rule 7.1A? Answer this question if the response to Q5.1 is “No”, the response to Q5.2 is “No” and the response to Q5.2c is “Yes”. If the response to Q5.2c is “Yes”, please complete and separately send by email to your ASX listings adviser a work sheet in the form of Annexure C to Guidance Note 21 confirming the entity has the available capacity under listing rule 7.1A to issue that number of securities. |
N/A |
Introduced 01/12/19; amended 31/01/20; 05/06/21
+ See chapter 19 for defined terms
5 June 2021Page 18
This appendix is available as an online formExhibit 99.2
Only use this form if the online version is not available+Rule 3.10.3E
Appendix 3H
Notification of cessation of +securities
Information and documents given to ASX become ASX’s property and may be made public.
*Denotes minimum information required for first lodgement of this form.
Part 1 – Entity and announcement details
Question no |
Question |
Answer |
1.1 |
*Name of entity We (the entity named above) provide the following information about our issued capital.1 |
MESOBLAST LTD |
1.2 |
*Registration type and number Please supply your ABN, ARSN, ARBN, ACN or another registration type and number (if you supply another registration type, please specify both the type of registration and the registration number). |
ABN 68 109 431 870 |
1.3 |
*ASX issuer code |
MSB |
1.4 |
*The announcement is Select whichever is applicable. |
☒New announcement ☐Update/amendment to previous announcement ☐Cancellation of previous announcement |
1.4a |
*Reason for update Answer this question if your response to Q 1.4 is “Update/amendment to previous announcement”. |
N/A |
1.4b |
*Date of previous announcement to this update Answer this question if your response to Q 1.4 is “Update/amendment to previous announcement”. |
N/A |
1.4c |
*Reason for cancellation Answer this question if your response to Q 1.4 is “Cancellation of previous announcement”. |
N/A |
1.4d |
*Date of previous announcement to this cancellation Answer this question if your response to Q 1.4 is “Cancellation”. |
N/A |
|
1 |
Listing rule 3.10.3E requires an entity to notify ASX of details of the cessation of: |
(a) |
any securities issued under an employee incentive scheme: |
(i) |
to key management personnel or an associate, within 5 business days of their cessation; |
(ii) |
to someone who is not key management personnel or an associate, within 10 business days of the end of the quarter in which the cessation occurred; |
(b) |
any other equity securities not otherwise notifiable to ASX under rule 3.8A, within 5 business days of their cessation; or |
(c) |
any quoted debt securities, within 5 business days of their cessation. |
The notification must be in the form of, or accompanied by, an Appendix 3H. |
Listing rule 3.8A requires an entity to notify ASX of the cessation of securities pursuant to a buy-back by giving ASX an Appendix 3H: |
• |
in the case of a minimum holding buy-back, within 5 business days of the completion of the buyback; or |
• |
in all other cases, within 5 business days of giving ASX the final notice for the buy-back. |
+ See chapter 19 for defined terms
5 June 2021Page 1
This appendix is available as an online formAppendix 3H
Notification of cessation of +securities
1.5 |
*Date of this announcement |
15 October 2021 |
+ See chapter 19 for defined terms
5 June 2021Page 2
This appendix is available as an online formAppendix 3H
Notification of cessation of +securities
Part 2 – |
Details of +equity securities or quoted +debt securities that have ceased |
Question No. |
Question |
Answer |
2.1 |
*ASX +security code and description |
MSBAI - Options expiring various dates ex various prices |
2.2 |
*Number of securities that have ceased |
156,668 |
2.3 |
*Reason for cessation Note: the conversion of a convertible security (which is notifiable to ASX under Listing Rule 3.10.3B) is not regarded as the “cessation” of the convertible security for the purposes of this rule. Likewise, the payment up of a partly paid security resulting in it becoming a fully paid security (which is notifiable to ASX under Listing Rule 3.10.3D) is not regarded as the “cessation” of the partly paid security for the purposes of this rule. |
☐Expiry of option or other convertible security without exercise or conversion ☒Lapse of conditional right to securities because the conditions have not been, or have become incapable of being, satisfied ☐Cancellation pursuant to a minimum holding buy-back ☐Cancellation pursuant to an employee share scheme buy-back ☐Cancellation pursuant to an on-market buy-back ☐Cancellation pursuant to an equal access scheme buy-back ☐Cancellation pursuant to a selective buy-back ☐Cancellation pursuant to another form of buy back ☐Cancellation pursuant to a reduction of capital ☐Cancellation pursuant to a scheme of arrangement or other reconstruction ☐Cancellation by agreement between the entity and the holder ☐Repayment or redemption of +convertible debt security without conversion ☐Repayment or redemption of quoted +debt security ☐Redemption of redeemable preference securities ☐Redemption of units ☐Cancellation of partly paid +securities upon which a call or instalment has not been paid ☐Other If you have selected ‘other’ please provide additional details regarding the reason for cessation here:
|
+ See chapter 19 for defined terms
5 June 2021Page 3
This appendix is available as an online formAppendix 3H
Notification of cessation of +securities
2.4 |
*Date of cessation |
133,334 on 30 September 2021; and 23,334 on 31 August 2021. |
2.5 |
*Is the entity paying any consideration for the cessation? Example: the payment of an amount to the holder of an option or right as consideration for the holder to agree to a cancellation of the option or right. The repayment of the principal amount of a convertible debt security or quoted debt security in accordance with its terms is not regarded as consideration paid for the cessation of that security. |
No |
2.6 |
*In what currency is the consideration being paid? Answer this question if your response to Q 2.5 is “Yes” |
N/A |
2.6a |
*Consideration amount per +security paid by the entity for the cessation Answer this question if your response to Q 2.5 is “Yes” The consideration amount per security should be provided per the currency specified in Q2.6. Note: This question is not applicable for buy-back events (i.e. Minimum Holding, Employee, On-Market, Equal Access, Selective), |
N/A |
2.6b |
*Total consideration paid or payable for the securities The total consideration amount should be provided per the currency specified in Q2.6.
Note: This question is applicable to buy-back events only (i.e. minimum holding, employee share scheme, on-market, equal access scheme, selective or other), |
N/A |
2.7 |
Any other information the entity wishes to notify to ASX about the cessation? |
N/A
|
Repeat the above questions if you are advising the cessation of more than one security class.
+ See chapter 19 for defined terms
5 June 2021Page 4
This appendix is available as an online formAppendix 3H
Notification of cessation of +securities
Part 3 – Issued capital following changes
Following the cessation of the +securities the subject of this notification, the issued capital of the entity will comprise: |
||||
3.1 |
*Quoted +equity securities and +debt securities (total number of each +class of +securities quoted on ASX)
|
|||
|
ASX +security code and description |
Total number of +securities on issue |
|
|
|
Ordinary shares
|
648,696,070 |
|
|
|
|
|
|
|
3.2 |
*Unquoted +equity securities (total number of each +class of +equity securities issued but not quoted on ASX):
|
|||
|
ASX +security code and description |
Total number of +securities on issue |
|
|
|
Unquoted options
Incentive Rights
Warrant |
42,644,134
1,500,000
15,027,327 |
|
|
|
|
|
|
|
Note: the figures provided in the tables in sections 3.1 and 3.2 above are used to calculate the total market capitalisation of the entity published by ASX from time to time. Please make sure you include in the relevant table each class of securities issued by the entity. If you have quoted CHESS Depository Interests (CDIs) issued over your securities, include them in the table in section 3.1. Restricted securities should only be included in the table in section 3.1 if you are applying to have them quoted because the escrow period for the securities has expired or is about to expire. Otherwise include them in the table in section 3.2. |
Introduced 05/06/21
+ See chapter 19 for defined terms
5 June 2021Page 5
Exhibit 99.3
|
REMESTEMCEL-L IMPROVES SURVIVAL OF CHILDREN WITH BIOMARKERS FOR HIGHEST MORTALITY IN STEROID REFRACTORY ACUTE GVHD
Melbourne, Australia; October 18, and New York, USA; October 17, 2021: Mesoblast Limited (ASX:MSB; Nasdaq:MESO), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that results published in the latest issue of the peer-reviewed journal Bone Marrow Transplantation1 showed that children with steroid-refractory acute graft versus host disease (SR-aGVHD) and biomarkers predictive for highest mortality had 64% survival when treated with remestemcel-L compared with only 10% survival when treated with other available therapies, including ruxolitinib or other biologics.
The study’s senior author and expert in the predictive biomarkers, Dr. James Ferrara, Ward-Coleman Chair in Cancer Medicine, Professor and Director Hematologic Malignancies Translational Research Center at The Icahn School of Medicine at Mount Sinai Hospital, said: “The findings support and extend recent studies that children with severe, SR acute GVHD benefit from remestemcel-L therapy.”
These data provide further support for the proposed anti-inflammatory mechanism of action of remestemcel-L and its immunomodulatory activity in patients with SR-aGVHD, resulting in improved survival outcomes. At its upcoming scheduled meeting with FDA’s Office of Tissue and Advanced Therapies (OTAT), Mesoblast will address the appropriateness of potency assays related to remestemcel-L’s proposed anti-inflammatory mechanism of action as well as the outstanding chemistry, manufacturing and controls (CMC) items which could support a resubmission of the current Biologics License Application (BLA) for remestemcel-L in the treatment of SR-aGVHD in children.
Summary of the study outcomes
The study compared outcomes in 25 children from Mesoblast’s Phase 3 trial of remestemcel-L in SR-aGVHD with 27 closely matched children from the Mount Sinai Acute GVHD International Consortium (MAGIC)2 who participated in a prospective natural history study and were matched for the Phase 3 trial entry criteria. The objective of the study was to evaluate whether outcomes differed according to treatment with remestemcel-L vs other therapies in children at highest risk of death, namely those with baseline MAGIC Algorithm Probability (MAP) biomarker levels ≥0.291, a level predictive of very high mortality and poor responses to therapy in SR-aGVHD. MAP combines the serum concentrations of two biomarkers, Reg3α and ST2, into a single value that predicts long-term outcomes and significant GI tract damage.
MAP levels ≥0.291 were present in 48% of remestemcel-L treated children (12/25) and 37% of the MAGIC cohort (10/27). Treatment with remestemcel-L resulted in 67% Day 28 Overall Response and 64% Day 180 overall survival compared with 10% Day 28 Overall Response and 10% Day 180 survival in the MAGIC cohort (both p=0.01) when treated with various biologics, including ruxolitinib. These results extend previous observations showing that children who achieved clinically meaningful responses and survival after treatment with remestemcel-L had significant reductions in the ST2 biomarker of inflammation, consistent with healing of the GI tract.3
About Steroid-Refractory Acute Graft Versus Host Disease (SR-aGVHD)
GVHD is a severe inflammation in the bloodstream caused by complications of bone marrow transplants. The disease occurs in up to 50% of the 30,000 patients who receive an allogeneic bone marrow transplant each year, primarily during treatment for blood cancers. In patients with the most severe form of GVHD, mortality can be as high as 90%. There are no therapies approved for treating SR-aGVHD in children under the age of 12.
About Mesoblast
Mesoblast is a world leader in developing allogeneic (off-the-shelf) cellular medicines for the treatment of severe and life-threatening inflammatory conditions. The Company has leveraged its proprietary mesenchymal lineage cell therapy technology platform to establish a broad portfolio of late-stage product candidates which respond to severe inflammation by releasing anti-inflammatory factors that counter and modulate multiple effector arms of the immune system, resulting in significant reduction of the damaging inflammatory process.
|
Mesoblast Limited
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 21 Biopolis Road #01-22 Nucleos (South Tower) SINGAPORE 138567
T +65 6570 0635 F +65 6570 0176 |
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Mesoblast has a strong and extensive global intellectual property portfolio with protection extending through to at least 2041 in all major markets. The Company’s proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide.
Mesoblast has completed Phase 3 trials of rexlemestrocel-L for advanced chronic heart failure and chronic low back pain. Remestemcel-L is being developed for inflammatory diseases in children and adults including steroid refractory acute graft versus host disease and moderate to severe acute respiratory distress syndrome. Two products have been commercialized in Japan and Europe by Mesoblast’s licensees, and the Company has established commercial partnerships in Europe and China for certain Phase 3 assets.
Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter: @Mesoblast
Footnotes
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Kasikis S., et al. Mesenchymal stromal cell therapy induces high responses and survival in children with steroid refractory GVHD and poor risk. Bone Marrow Transplantation 2021; https://doi.org/10.1038/s41409-021-01442-3 |
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Mount Sinai Acute GVHD International Consortium (MAGIC) - a group of ten BMT centers throughout the US and Europe whose purpose is to conduct ground-breaking clinical trials in GVHD, including developing informative biorepositories that assist in developing treatments that can guide GVHD therapy |
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Presented at the annual meeting of the American Society of Hematology (ASH) 2020 |
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. All statements other than statements of historical fact, including our intention to discuss a regulatory pathway with the FDA, are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “likely,” “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions and variations thereof. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. The risks, uncertainties and other factors that may impact our forward-looking statements include, but are not limited to: the timing, progress and results of Mesoblast’s preclinical and clinical studies; Mesoblast’s ability to advance product candidates into, enroll and successfully complete, clinical studies; the timing or likelihood of regulatory filings and approvals; whether the FDA agrees to a regulatory pathway; and the pricing and reimbursement of Mesoblast’s product candidates, if approved; Mesoblast’s ability to establish and maintain intellectual property on its product candidates and Mesoblast’s ability to successfully defend these in cases of alleged infringement. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblast’s 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. Unless required by law, 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.
Release authorized by the Chief Executive.
For more information, please contact:
Corporate Communications / Investors |
Media |
Paul Hughes |
Sumit Media |
T: +61 3 9639 6036 |
Grant Titmus |
E: investors@mesoblast.com |
T: +61 419 388 161 |
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E: grant@sumitmedia.com.au |
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Kristen Bothwell |
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T: +1 917 613 5434 |
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E: kbothwell@rubenstein.com |
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Mesoblast Limited
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 21 Biopolis Road #01-22 Nucleos (South Tower) SINGAPORE 138567
T +65 6570 0635 F +65 6570 0176 |
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