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 February 2020
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 February 20, 2020, 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 February 21, 2020, Mesoblast Limited filed with the Australian Securities Exchange a new issue announcement, application for quotation of additional securities (Appendix 3G), which is attached hereto as Exhibit 99.2, and is incorporated herein by reference.
On February 24, 2020, 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.
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: February 25, 2020
Item |
|
|
|
|
|
99.1 |
|
Press release of Mesoblast Ltd, dated February 20, 2020. |
99.2 |
|
Appendix 3G of Mesoblast Ltd, dated February 21, 2020. |
99.3 |
|
Press release of Mesoblast Ltd, dated February 24, 2020 |
Exhibit 99.1
|
CLINICALLY MEANINGFUL OUTCOMES USING REMESTEMCEL-L
IN PATIENTS WITH CHRONIC GRAFT VERSUS HOST DISEASE
Melbourne, Australia, February 20, 2020 and New York, USA, February 19, 2020: Mesoblast Limited (ASX:MSB; Nasdaq:MESO), global leader in cellular medicines for inflammatory diseases, today announced that the investigator-initiated expanded access protocol using its cryopreserved allogeneic cell therapy product candidate remestemcel-L for steroid-refractory chronic graft versus host disease (chronic GVHD) has resulted in clinically meaningful outcomes in all three treated patients, two children and one adult, within 28 days after two infusions. On the basis of these outcomes, the investigator-initiated collaboration will be expanded to evaluate remestemcel-L in a pivotal trial for chronic GVHD.
Lead investigator Dr Joanne Kurtzberg, Jerome Harris Distinguished Professor of Pediatrics and Professor of Pathology, and Director, Pediatric Blood and Marrow Transplant Program at Duke University Medical Center, said: “We are delighted with these initial efficacy outcomes using remestemcel-L as first-line therapy in steroid-refractory chronic graft versus host disease, where there is a major unmet medical need for a safe and effective therapy.”
Chronic GVHD occurs in 30-70% of recipients of an allogeneic bone marrow transplant.1,2 Over 30,000 patients worldwide undergo an allogeneic bone marrow transplant annually, primarily during treatment for blood cancers, and these numbers are increasing.3 In both the chronic and acute forms of GVHD, the donated bone marrow stem cells view the recipient’s body as foreign, and attack the body causing significant morbidity and mortality. Acute GVHD usually manifests within 100 days following a transplant while chronic GVHD generally manifests later (>100 days), and the two may occur separately or within the same patient. The prevalence of chronic GVHD in the US is over 14,000 patients, with an estimated annual patient medical cost of approximately US$300,000.4
About Remestemcel-L
Remestemcel-L is an investigational therapy being developed for a range of rare diseases. The product candidate comprises culture-expanded mesenchymal stem cells derived from the bone marrow of an unrelated donor. Remestemcel-L is believed to have immunomodulatory properties to counteract the inflammatory processes that are implicated in steroid-refractory GVHD by down-regulating the production of pro-inflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues.
References
1. Arai et al. Biol Blood Marrow Transplant. 2015; 21(2): 266–274.
2. Grube et al. Biol Blood Marrow Transplant: 2016; 22 (10): 1781-179.
3. Niederwieser D, Baldomero H, Szer J. (2016) Hematopoietic stem cell transplantation activity worldwide in 2012 and a SWOT analysis of the Worldwide Network for Blood and Marrow Transplantation Group including the global survey.
4. Bachier C, Aggarwal S, Hennegan K (2019) Epidemiology and Real-World Treatment of Chronic Graft-Versus-Host Disease Post Allogeneic Hematopoietic Cell Transplantation: A US Claims Analysis. Blood 2019; 134:Supplement 1.
|
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 |
|
|
|
|
|
|
|
Mesoblast Limited (ASX: MSB; Nasdaq: MESO) is a world leader in developing allogeneic (off-the-shelf) cellular medicines. The Company has leveraged its proprietary mesenchymal lineage cell therapy technology platforms to establish a broad portfolio of commercial products and late-stage product candidates. Mesoblast’s proprietary manufacturing process yields 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 filed a Biologics License Application to the United States Food and Drug Administration (FDA) to seek approval of its product candidate Ryoncil™ (remestemcel-L) for steroid-refractory acute graft versus host disease (acute GvHD). Remestemcel-L is also being developed for other rare diseases. Mesoblast is completing Phase 3 trials for its rexlemestrocel product candidates for advanced heart failure and chronic low back pain. If approved, RYONCIL is expected to be launched in the United States in 2020 for pediatric steroid-refractory acute GVHD. 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
Mesoblast’s 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 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. Forward-looking statements include, but are not limited to, statements about 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; and the pricing and reimbursement of Mesoblast’s product candidates, if approved. 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. 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 further information, please contact:
Julie Meldrum
Corporate Communications
T: +61 3 9639 6036
E: julie.meldrum@mesoblast.com
Schond Greenway
Investor Relations
T: +1 212 880 2060
E: schond.greenway@mesoblast.com
|
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 |
|
|
|
|
|
|
|
Exhibit 99.2
This appendix is not available as an online form |
|
Please fill in and submit as a PDF announcement |
+Rule 3.10.3A, 3.10.3B, 3.10.3C |
Appendix 3G
Notification of issue, conversion or payment up of equity +securities
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 |
21 February 2020 |
+ See chapter 19 for defined terms |
|
31 January 2020 |
Page 1 |
This appendix is not available as an online form |
Appendix 3G |
Please fill in and submit as a PDF announcement |
Notification of issue, conversion or |
|
payment up of equity +securities |
Question No. |
Question |
Answer |
||||
2.1 |
*The +securities the subject of this notification are: Select whichever item is applicable. If you wish to notify ASX of different types of issues of securities, please complete a separate Appendix 3G for each type of issue. |
☐ +Securities issued as a result of options being exercised or other +convertible +securities being converted and that are not to be quoted on ASX ☐ Partly paid +securities that have been fully paid up and that are not to be quoted on ASX ☒ +Securities issued under an +employee incentive scheme that are not being immediately quoted on ASX ☐ Other [please specify] If you have selected ‘other’ please provide the circumstances of the issue here:
|
||||
2.2a.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 “securities issued as a result of options being exercised or other convertible securities being converted and that are not to be quoted on ASX”. |
N/A |
||||
2.2a.2 |
And the date the options were exercised or other +convertible securities were converted: Answer this question if your response to Q2.1 is “securities issued as a result of options being exercised or other convertible securities being converted and that are not 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. |
N/A |
||||
2.2b.1 |
Please state the number and type of partly paid +securities that were fully paid up (including their ASX security code if available)? Answer this question if your response to Q2.1 is “partly paid securities that have been paid up and that are not to be quoted on ASX”. |
N/A |
||||
2.2b.2 |
And the date the +securities were fully paid up: Answer this question if your response to Q2.1 is “partly paid securities that have been paid up and that are not to be quoted on ASX”. Note: If this occurred over a range of dates, enter the date the last of the securities was fully paid up. |
N/A |
+ See chapter 19 for defined terms |
|
31 January 2020 |
Page 2 |
This appendix is not available as an online form |
Appendix 3G |
Please fill in and submit as a PDF announcement |
Notification of issue, conversion or |
|
payment up of equity +securities |
Please state the number and type of +securities (including their ASX security code) issued under an +employee incentive scheme that are not being immediately quoted on ASX Answer this question if your response to Q2.1 is “securities issued under an employee incentive scheme that are not being immediately quoted on ASX”. |
5,180,000 unquoted options to acquire ordinary shares, issued pursuant to the Company’s Employee Share Option Plan |
|||||
2.2c.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 not being immediately quoted on ASX”. |
Refer to Item 6 in Notice of Meeting released 27 November 2019 https://www.asx.com.au/asxpdf/20191029/pdf/44b06zfvzb0vzb.pdf |
||||
2.2c.3 |
*Are any of these +securities being 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 not being immediately quoted on ASX”. |
No |
||||
2.2c.3.a |
*Provide details of the recipients and the number of +securities issued to each of them. Answer this question if your response to Q2.1 is “securities issued under an employee incentive scheme that are not being immediately quoted on ASX” and your response to Q2.2c.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”.
|
|||||
|
|
Name of KMP |
Name of registered holder |
Number of +securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2.2d.1 |
*The purpose(s) for which the entity is issuing the +securities is: 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: |
||||
2.2d.2 |
Please provide any further information needed to understand the circumstances in which you are notifying the issue of these +securities to ASX, including (if applicable) 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 |
+ See chapter 19 for defined terms |
|
31 January 2020 |
Page 3 |
This appendix is not available as an online form |
Appendix 3G |
Please fill in and submit as a PDF announcement |
Notification of issue, conversion or |
|
payment up of equity +securities |
*The +securities being issued are: Tick whichever is applicable |
☐ Additional +securities in an existing unquoted class that is already recorded by ASX ("existing class") ☒ New +securities in an unquoted class that is not yet recorded by ASX ("new class") |
Part 3A – |
number and type of +securities being issued (existing class) |
Answer the questions in this part if your response to Q2.3 is “existing class”.
Question No. |
Question |
Answer |
3A.1 |
*ASX security code & description |
N/A |
3A.2 |
*Number of +securities being issued |
N/A |
3A.3a |
*Will the +securities being issued rank equally in all respects from their issue date with the existing issued +securities in that class? |
N/A |
3A.3b |
*Is the actual date from which the +securities will rank equally (non-ranking end date) known? Answer this question if your response to Q3A.3a is “No”. |
N/A |
3A.3c |
*Provide the actual non-ranking end date Answer this question if your response to Q3A.3a is “No” and your response to Q3A.3b is “Yes”. |
N/A |
3A.3d |
*Provide the estimated non-ranking end period Answer this question if your response to Q3A.3a is “No” and your response to Q3A.3b is “No”. |
N/A |
3A.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 Answer this question if your response to Q3A.3a 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 |
+ See chapter 19 for defined terms |
|
31 January 2020 |
Page 4 |
This appendix is not available as an online form |
Appendix 3G |
Please fill in and submit as a PDF announcement |
Notification of issue, conversion or |
|
payment up of equity +securities |
Part 3B –number and type of +securities being issued (new class)
Answer the questions in this part if your response to Q2.3 is “new class”.
Question No. |
Question |
Answer |
3B.1 |
*Security description |
4,780,000 unquoted options to acquire ordinary shares at a price per share of A$1.62, vesting in three equal tranches on 20 July 2020, 20 July 2021 and 20 July 2022 respectively, and expiring on 19 July 2026
400,000 unquoted options to acquire ordinary shares at a price per share of A$1.62, vesting in three equal tranches on 28 August 2020, 28 August 2021 and 28 August 2022 respectively, and expiring on 28 August 2026 |
3B.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 |
3B.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 |
3B.4 |
*Number of +securities being issued |
5,180,000 unquoted options |
3B.5a |
*Will all the +securities issued in this class rank equally in all respects from the issue date? |
Yes |
3B.5b |
*Is the actual date from which the +securities will rank equally (non-ranking end date) known? Answer this question if your response to Q3B.5a is “No”. |
N/A |
3B.5c |
*Provide the actual non-ranking end date Answer this question if your response to Q3B.5a is “No” and your response to Q3B.5b is “Yes”. |
N/A |
3B.5d |
*Provide the estimated non-ranking end period Answer this question if your response to Q3B.5a is “No” and your response to Q3B.5b is “No”. |
N/A |
+ See chapter 19 for defined terms |
|
31 January 2020 |
Page 5 |
This appendix is not available as an online form |
Appendix 3G |
Please fill in and submit as a PDF announcement |
Notification of issue, conversion or |
|
payment up of equity +securities |
*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 Q3B.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 |
|
3B.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. |
Refer to Item 6 in Notice of Meeting released 27 November 2019 https://www.asx.com.au/asxpdf/20191029/pdf/44b06zfvzb0vzb.pdf |
3B.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. |
No |
3B.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 |
|
*Will there be 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 |
+ See chapter 19 for defined terms |
|
31 January 2020 |
Page 6 |
This appendix is not available as an online form |
Appendix 3G |
Please fill in and submit as a PDF announcement |
Notification of issue, conversion or |
|
payment up of equity +securities |
+ See chapter 19 for defined terms |
|
31 January 2020 |
Page 7 |
This appendix is not available as an online form |
Appendix 3G |
Please fill in and submit as a PDF announcement |
Notification of issue, conversion or |
|
payment up of equity +securities |
|
*Interest rate type 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 |
|
*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 |
+ See chapter 19 for defined terms |
|
31 January 2020 |
Page 8 |
This appendix is not available as an online form |
Appendix 3G |
Please fill in and submit as a PDF announcement |
Notification of issue, conversion or |
|
payment up of equity +securities |
+ See chapter 19 for defined terms |
|
31 January 2020 |
Page 9 |
This appendix is not available as an online form |
Appendix 3G |
Please fill in and submit as a PDF announcement |
Notification of issue, conversion or |
|
payment up of equity +securities |
Question No. |
Question |
Answer |
4.1 |
*Have the +securities been issued yet? |
Yes |
4.1a |
*What was their date of issue? Answer this question if your response to Q4.1 is “Yes”. |
14 February 2020 |
4.1b |
*What is their proposed date of issue? Answer this question if your response to Q4.1 is “No”. |
N/A |
4.2 |
*Are the +securities being issued for a cash consideration? If the securities are being issued for nil cash consideration, answer this question “No”. |
No |
4.2a |
*In what currency is the cash consideration being paid For example, if the consideration is being paid in Australian Dollars, state AUD. Answer this question if your response to Q4.2 is “Yes”. |
N/A |
4.2b |
*What is the issue price per +security Answer this question if your response to Q4.2 is “Yes” and by reference to the issue currency provided in your response to Q4.2a. Note: you cannot enter a nil amount here. If the securities are being issued for nil cash consideration, answer Q4.2 as “No” and complete Q4.2c. |
N/A |
4.2c |
Please describe the consideration being provided for the +securities Answer this question if your response to Q4.2 is “No”. |
Securities being issued under the Employee Share Option Plan |
4.3 |
Any other information the entity wishes to provide about the issue |
N/A |
Part 5 – Unquoted +securities on issue
Following the issue of the +securities the subject of this application, the unquoted issued +securities of the entity will comprise: Note: the figures provided in the table in section 5.1 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 unquoted securities issued by the entity. Restricted securities should be included in table 5.1. |
||||
5.1 |
|
|
|
|
|
|
|
|
|
|
|
*ASX security code and description |
*Total number of +securities on issue |
|
|
|
Unquoted options
Incentive rights
|
29,638,001
1,500,000 |
|
|
|
|
|
|
+ See chapter 19 for defined terms |
|
31 January 2020 |
Page 10 |
This appendix is not available as an online form |
Appendix 3G |
Please fill in and submit as a PDF announcement |
Notification of issue, conversion or |
|
payment up of equity +securities |
Part 6 – 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 an +employee incentive scheme that are not being immediately quoted on ASX”; or |
- |
your response to Q2.1 is “Other” |
Question No. |
Question |
Answer |
6.1 |
*Are the securities being issued under Listing Rule 7.2 exception 131 and therefore the issue does not need any security holder approval under Listing Rule 7.1? Answer this question if your response to Q2.1 is “securities issued under an employee incentive scheme that are not being immediately quoted on ASX”. |
Yes |
6.2 |
*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 Q6.1 is “No”. |
N/A |
6.2a |
*Date of meeting or proposed meeting to approve the issue under listing rule 7.1 Answer this question if the response to Q6.1 is “No” and the response to Q6.2 is “Yes”. |
N/A |
6.2b |
*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 Q6.1 is “No” and the response to Q6.2 is “No”. |
N/A |
1 Exception 13 |
An issue of securities under an employee incentive scheme if within 3 years before the issue date: |
|
(a) |
in the case of a scheme established before the entity was listed – a summary of the terms of the scheme and the maximum number of equity securities proposed to be issued under the scheme were set out in the prospectus, PDS or information memorandum lodged with ASX under rule 1.1 condition 3; or |
|
(b) |
the holders of the entity’s ordinary securities have approved the issue of equity securities under the scheme as an exception to this rule. The notice of meeting must have included: |
|
• |
a summary of the terms of the scheme. |
|
• |
the number of securities issued under the scheme since the entity was listed or the date of the last approval under this rule; |
|
• |
the maximum number of +equity securities proposed to be issued under the scheme following the approval; and |
|
• |
a voting exclusion statement. |
Exception 13 is only available if and to the extent that the number of +equity securities issued under the scheme does not exceed the maximum number set out in the entity’s prospectus, PDS or information memorandum (in the case of (a) above) or in the notice of meeting (in the case of (b) above).
Exception 13 ceases to be available if there is a material change to the terms of the scheme from those set out in the entity’s prospectus, PDS or information memorandum (in the case of (a) above) or in the notice of meeting (in the case of (b) above).
+ See chapter 19 for defined terms |
|
31 January 2020 |
Page 11 |
This appendix is not available as an online form |
Appendix 3G |
Please fill in and submit as a PDF announcement |
Notification of issue, conversion or |
|
payment up of equity +securities |
*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 Q6.1 is “No”, the response to Q6.2 is “No” and the response to Q6.2b 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 |
|
6.2c |
*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 Q6.1 is “No” and the response to Q6.2 is “No”. |
N/A |
6.2c.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 Q6.1 is “No”, the response to Q6.2 is “No” and the response to Q6.2c 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
+ See chapter 19 for defined terms |
|
31 January 2020 |
Page 12 |
Exhibit 99.3
|
CONSISTENT OUTCOMES USING RYONCIL™ AS FIRST-LINE TREATMENT OR SALVAGE THERAPY IN 309 CHILDREN WITH STEROID-REFRACTORY ACUTE GVHD
Melbourne, Australia; February 24, 2020; and New York, USA; February 23, 2020: Mesoblast Limited (ASX:MSB; Nasdaq:MESO) today announced that aggregated results from 309 children treated with Ryoncil™ (remestemcel-L) were presented at the American Society for Transplantation Cellular Therapy and the Center for International Blood & Bone Marrow Transplant Research (TCT) meeting in Orlando, Florida on February 22. The data showed that treatment with RYONCIL across three separate trials resulted in consistent treatment responses and survival outcomes in children with steroid-refractory acute graft versus host disease (SR-aGVHD).
Key findings and conclusions were:
|
• |
Consistent safety and efficacy were observed across the continuum from first-line treatment after steroid failure through the most challenging patients who received RYONCIL as salvage after exhausting all other options. |
|
• |
In the aggregated dataset, 204 of the 309 (66%) patients achieved an overall response at Day 28 following a four-week course of RYONCIL. |
|
• |
Results were consistent across all grades of disease, including most severe (IBMTR Grade C/D or Glucksberg Grade 3/4). |
|
• |
In the most severe patients (Grade C/D), who accounted for 82% of all treated patients, Day 28 overall response was 65%. |
|
• |
Overall response at Day 28 was strongly predictive of survival at Day 100 and Day 180. |
|
• |
Day 28 responders were more than twice as likely to survive as non-responders (84% vs 39% at Day 100, and 83% vs 38% at Day 180). |
|
• |
RYONCIL was well tolerated with no infusion-related toxicity and no identified safety concerns. |
Mesoblast Chief Medical Officer Dr Fred Grossman said: “These aggregated data from three studies demonstrate consistent efficacy and safety of RYONCIL in children suffering from steroid refractory acute graft versus host disease. If approved, RYONCIL has the potential to be an effective and safe therapy to improve survival outcomes in the most vulnerable population of children with severe forms of this disease who can have mortality rates as high as 90 percent.”
In January, Mesoblast filed a Biologics License Application (BLA) to the United States Food and Drug Administration (FDA) for RYONCIL for the treatment of children with steroid-refractory aGVHD. The Company has requested Priority Review of the BLA by the FDA under the product candidate’s existing Fast Track designation. If approved, RYONCIL is expected to be launched in the US in 2020.
About Acute GVHD
Acute GVHD occurs in approximately 50% of patients who receive an allogeneic bone marrow transplant (BMT). Over 30,000 patients worldwide undergo an allogeneic BMT annually, primarily during treatment for blood cancers, and these numbers are increasing.1 In patients with the most severe form of acute GVHD (Grade C/D or III/IV) mortality is as high as 90% despite optimal institutional standard of care.2,3. There are currently no FDA-approved treatments in the US for children under 12 with SR-aGVHD.
|
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 |
|
|
|
|
|
|
|
Mesoblast’s lead product candidate, RYONCIL, is an investigational therapy comprising culture- expanded mesenchymal stem cells derived from the bone marrow of an unrelated donor. It is administered to patients in a series of intravenous infusions. RYONCIL is believed to have immunomodulatory properties to counteract the inflammatory processes that are implicated in SR- aGVHD by down-regulating the production of pro-inflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues.
References
1. Niederwieser D, Baldomero H, Szer J. (2016) Hematopoietic stem cell transplantation activity worldwide in 2012 and a SWOT analysis of the Worldwide Network for Blood and Marrow Transplantation Group including the global survey.
2. Westin, J., Saliba, RM., Lima, M. (2011) Steroid-refractory acute GVHD: predictors and outcomes. Advances in Hematology.
3. Axt L, Naumann A, Toennies J (2019) Retrospective single center analysis of outcome, risk factors and therapy in steroid refractory graft-versus-host disease after allogeneic hematopoietic cell transplantation. Bone Marrow Transplantation.
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 mesenchymal lineage cell therapy technology platforms to establish a broad portfolio of commercial products and late-stage product candidates. Mesoblast’s proprietary manufacturing process yields 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 filed a Biologics License Application to the United States Food and Drug Administration (FDA) to seek approval of its product candidate Ryoncil™ (remestemcel-L) for steroid-refractory acute graft versus host disease (acute GvHD). Remestemcel-L is also being developed for other rare diseases. Mesoblast is completing Phase 3 trials for its rexlemestrocel product candidates for advanced heart failure and chronic low back pain. If approved, RYONCIL is expected to be launched in the United States in 2020 for pediatric steroid-refractory acute GVHD. 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
|
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 |
|
|
|
|
|
|
|
Mesoblast’s 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 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. Forward-looking statements include, but are not limited to, statements about 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; and the pricing and reimbursement of Mesoblast’s product candidates, if approved. 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. 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 further information, please contact:
Julie Meldrum
Corporate Communications
T: +61 3 9639 6036
E: julie.meldrum@mesoblast.com
Schond Greenway
Investor Relations
T: +1 212 880 2060
E: schond.greenway@mesoblast.com
|
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 |
|
|
|
|
|
|
|