Mesoblast Ltd 6-K, filed Aug 22, 2022
Mesoblast Ltd (MESO)
About this 6-K
Mesoblast Ltd filed this 6-K on August 22, 2022.
|
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 August 2022
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 August 18, 2022, 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 August 18, 2022, Mesoblast Limited submitted an Initial Director’s Interest Notice (Appendix 3X) to the Australian Securities Exchange, a copy of which is attached to this report as Exhibit 99.2, and is incorporated herein by reference.
On August 18, 2022, Mesoblast Limited submitted a Final Director’s Interest Notice (Appendix 3Z) to the Australian Securities Exchange, a copy of which is attached to this report 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.
|
|
|
|
|
|
|
|
|
Mesoblast Limited |
|
|
|
|
|
/s/ Niva Sivakumar |
|
|
|
|
|
|
|
|
|
|
|
Niva Sivakumar |
|
|
|
|
|
Company Secretary
|
|
|
Dated: August 19, 2022
INDEX TO EXHIBITS
|
|
|
|
|
Item |
|
|
|
|
|
|
|
99.1 |
|
Press release of Mesoblast Ltd, dated August 18, 2022. |
|
99.2 |
|
Initial Director’s Interest Notice, Jane C. Bell, dated August 18, 2022. |
|
99.3 |
|
Final Director’s Interest Notice, Shawn Cline Tomasello, dated August 18, 2022. |
Exhibit 99.1
|
|
|
|
JANE BELL JOINS MESOBLAST BOARD
Melbourne, Australia; August 18 and New York, USA; August 17, 2022: Mesoblast Limited (ASX:MSB; Nasdaq:MESO), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that it has appointed Jane Bell to its Board of Directors. Ms Bell is a banking and finance lawyer with 22 years of corporate finance expertise focussing on international investment transactions in the United States, Canada, Australia and the United Kingdom, including funds management, mergers, acquisitions, and divestments. She has served as a non-executive Director in a diverse range of highly regulated sectors including delivery of healthcare, life sciences, medical research, and funds management.
Ms Bell currently serves as Deputy Chair of Monash Health, one of Australia’s largest and most diverse public health service delivering more than 3.46 million episodes of care across an extensive network of hospitals, rehabilitation, aged care, community health and mental health facilities and a former Chair of Melbourne Health. From 2014 until 2021 she was a director of U Ethical, Australia’s first ethical funds manager with over $1.2B of funds under management, and a member of its Investment Committee. She has also been a director of Hudson Institute of Medical Research, is currently a director of Amplia Therapeutics, and Chairs Advisory Groups for the Royal Australian and New Zealand College of Obstetricians and Melbourne Genomics Health Alliance.
Commenting on her appointment Ms Bell said “I look forward to joining the Mesoblast Board at such an exciting stage in the company’s transition to a commercial organization, with its deep cell therapy product pipeline. The potential FDA approval and launch in the US market of the first allogeneic cell therapy is an incredibly exciting opportunity for me to be involved with and I look forward to using my background and experience to make a strong contribution.”
In other board changes, Shawn Tomasello will retire after four years on the Board. Ms Tomasello said, “I am confident that Mesoblast will successfully execute commercially on its potential first product launch, and the promise of its leading edge technology and I’ll be following closely from the sidelines”.
Mesoblast Chairman Joseph Swedish welcomed Ms Bell to the Board and thanked Ms Tomasello for her contributions. Mr Swedish said “We are delighted to have Jane join Mesoblast as an Independent Non-Executive Director. She has extensive corporate finance experience and diverse involvement across a wide range of healthcare and corporate finance organizations.”
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 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 is developing product candidates for distinct indications based on its remestemcel-L and rexlemestrocel-L allogeneic stromal cell technology platforms. Remestemcel-L is being developed for inflammatory diseases in children and adults including steroid refractory acute graft versus host disease, biologic-resistant inflammatory bowel disease, and acute respiratory distress syndrome. Rexlemestrocel-L is in development for advanced chronic heart failure and chronic low back pain. 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 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 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
Forward-Looking Statements
This press release 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 initiation, timing, progress and results of Mesoblast’s preclinical and clinical studies, and Mesoblast’s research and development programs; Mesoblast’s ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; Mesoblast’s ability to advance its manufacturing capabilities; the timing or likelihood of regulatory filings and approvals (including BLA resubmission), manufacturing activities and product marketing activities, if any; the commercialization of Mesoblast’s product candidates, if approved; regulatory or public perceptions and market acceptance surrounding the use of stem-cell based therapies; the potential for Mesoblast’s product candidates, if any are approved, to be withdrawn from the market due to patient adverse events or deaths; the potential benefits of strategic collaboration agreements and Mesoblast’s ability to enter into and maintain established strategic collaborations; 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; the scope of protection Mesoblast is able to establish and maintain for intellectual property rights covering its product candidates and technology; estimates of Mesoblast’s expenses, future revenues, capital requirements and its needs for additional financing; Mesoblast’s financial performance; developments relating to Mesoblast’s competitors and industry; 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 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 |
|
|
E: grant@sumitmedia.com.au |
|
|
|
|
|
Rubenstein |
|
|
Tali Mackay |
|
|
E: tmackay@rubenstein.com |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exhibit 99.2
Appendix 3X
Initial Director’s Interest Notice
Rule 3.19A.1
Appendix 3X
Initial Director’s Interest Notice
Information or documents not available now must be given to ASX as soon as available. Information and documents given to ASX become ASX’s property and may be made public.
Introduced 30/9/2001.
|
Name of entity Mesoblast Limited |
|
ABN 68 109 431 870 |
We (the entity) give ASX the following information under listing rule 3.19A.1 and as agent for the director for the purposes of section 205G of the Corporations Act.
|
Name of Director |
Jane C. Bell |
|
Date of appointment |
18 August 2022 |
Part 1 - Director’s relevant interests in securities of which the director is the registered holder
In the case of a trust, this includes interests in the trust made available by the responsible entity of the trust
Note: In the case of a company, interests which come within paragraph (i) of the definition of “notifiable interest of a director” should be disclosed in this part.
|
Number & class of securities
114,285 Ordinary fully paid shares
|
+ See chapter 19 for defined terms.
|
11/3/2002 |
Appendix 3X Page 1 |
Appendix 3X
Initial Director’s Interest Notice
Part 2 – Director’s relevant interests in securities of which the director is not the registered holder
In the case of a trust, this includes interests in the trust made available by the responsible entity of the trust
|
Name of holder & nature of interest Note: Provide details of the circumstances giving rise to the relevant interest.
Mrs. Jane Catherine Bell and Mr Geoffrey Arthur Bell as trustees for Schooner Super Fund
|
Number & class of Securities
114,285 Ordinary fully paid shares |
Part 3 – Director’s interests in contracts
Note: In the case of a company, interests which come within paragraph (ii) of the definition of “notifiable interest of a director” should be disclosed in this part.
|
Detail of contract |
9/08/2022 |
|
Nature of interest
|
Ordinary fully paid shares On market purchase |
|
|
|
|
No. and class of securities to which interest relates
|
114,285 Ordinary fully paid shares |
+ See chapter 19 for defined terms.
|
Appendix 3X Page 2 |
11/3/2002 |
Exhibit 99.3
Appendix 3Z
Final Director’s Interest Notice
Rule 3.19A.3
Appendix 3Z
Final Director’s Interest Notice
Information or documents not available now must be given to ASX as soon as available. Information and documents given to ASX become ASX’s property and may be made public.
Introduced 30/9/2001.
|
Name of entity Mesoblast Limited |
|
ABN 68 109 431 870 |
We (the entity) give ASX the following information under listing rule 3.19A.3 and as agent for the director for the purposes of section 205G of the Corporations Act.
|
Name of director |
Shawn Cline Tomasello |
|
Date of last notice |
8 January 2019 |
|
Date that director ceased to be director |
18 August 2022 |
Part 1 – Director’s relevant interests in securities of which the director is the registered holder
In the case of a trust, this includes interests in the trust made available by the responsible entity of the trust
Note: In the case of a company, interests which come within paragraph (i) of the definition of “notifiable interest of a director” should be disclosed in this part.
|
Number & class of securities
200,000 options
|
+ See chapter 19 for defined terms.
|
11/3/2002 |
Appendix 3Z Page 1 |
Appendix 3Z
Final Director’s Interest Notice
Part 2 – Director’s relevant interests in securities of which the director is not the registered holder
Note: In the case of a company, interests which come within paragraph (ii) of the definition of “notifiable interest of a director” should be disclosed in this part.
In the case of a trust, this includes interests in the trust made available by the responsible entity of the trust
|
Name of holder & nature of interest Note: Provide details of the circumstances giving rise to the relevant interest
|
Number & class of securities
Nil |
Part 3 – Director’s interests in contracts
|
Detail of contract |
N/A |
|
Nature of interest
|
N/A |
|
Name of registered holder (if issued securities)
|
N/A |
|
No. and class of securities to which interest relates
|
N/A |
+ See chapter 19 for defined terms.
|
Appendix 3Z Page 2 |
11/3/2002 |