MESO Mesoblast Limited

15.12
+0.03  (+0%)
Previous Close 15.09
Open 15
52 Week Low 3.1201
52 Week High 21.28
Market Cap $1,771,444,473
Shares 117,159,026
Float 117,159,026
Enterprise Value $1,773,175,444
Volume 307,345
Av. Daily Volume 592,370
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Upcoming Catalysts

Drug Stage Catalyst Date
Rexlemestrocel
Heart failure
Phase 3
Phase 3
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Rexlemestrocel (MPC-06-ID)
Chronic low back pain
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
Remestemcel-L
COVID-19
Phase 3
Phase 3
Phase 3 trial to continue following recommendation from the independent Data Safety Monitoring Board (DSMB) following second interim analysis.
Remestemcel-L (MSC-100-IV)
acute graft versus host disease (aGVHD) in children
CRL
CRL
CRL announced October 1, 2020.
MPC-150-IM
End-Stage Heart Failure with LVADs
Phase 2b
Phase 2b
Phase 2b trial did not meet primary endpoint - November 11, 2018.
MPC-300-IV
Rheumatoid arthritis
Phase 2
Phase 2
Phase 2 data released August 2016. Partnership required for Phase 3 development.

Latest News

  1. NEW YORK, Dec. 02, 2020 (GLOBE NEWSWIRE) -- Mesoblast Limited (NASDAQ:MESO, ASX:MSB))), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation for remestemcel-L in the treatment of acute respiratory distress syndrome (ARDS) due to COVID-19 infection. Fast Track designation is granted if a therapy demonstrates the potential to address unmet medical needs for a serious or life-threatening disease.1 ARDS is the primary cause of death in patients with COVID-19.

    Fast Track designation by the FDA is intended to facilitate development and expedite review of therapies to treat serious and life-threatening conditions with…

    NEW YORK, Dec. 02, 2020 (GLOBE NEWSWIRE) -- Mesoblast Limited (NASDAQ:MESO, ASX:MSB))), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation for remestemcel-L in the treatment of acute respiratory distress syndrome (ARDS) due to COVID-19 infection. Fast Track designation is granted if a therapy demonstrates the potential to address unmet medical needs for a serious or life-threatening disease.1 ARDS is the primary cause of death in patients with COVID-19.

    Fast Track designation by the FDA is intended to facilitate development and expedite review of therapies to treat serious and life-threatening conditions with no or limited treatment options so that an approved product can reach the market expeditiously.1 Under Fast Track designation, a Biologic License Application (BLA) for remestemcel-L is eligible for both rolling submission and priority review.

    Clinical data provided to the FDA supporting the potential of remestemcel-L to address the unmet medical need of COVID-19 ARDS included results from a pilot study of remestemcel-L under emergency compassionate use at New York's Mt Sinai Hospital in March-April this year. In this study, nine of 12 ventilator-dependent patients (75%) with moderate to severe COVID-19 ARDS were successfully discharged from hospital a median of 10 days after receiving two intravenous doses of remestemcel-L. 

    The ongoing randomized controlled Phase 3 trial of remestemcel-L in up to 300 ventilator-dependent patients with moderate to severe COVID-19 ARDS, under an FDA Investigational New Drug clearance, is approximately two-thirds enrolled. The trial's primary endpoint is overall mortality at Day 30, and the key secondary endpoint is days alive off ventilatory support through Day 60. Two interim analyses have been performed by the independent Data Safety Monitoring Board (DSMB), after 90 and 135 patients were enrolled, with recommendations to continue the trial as planned. A third and final interim analysis is planned to be performed by the DSMB when 180 patients have completed 30 days of follow-up.

    Mesoblast recently entered into a license and collaboration agreement with Novartis for the development, manufacture and commercialization of remestemcel-L, with an initial focus on the treatment of ARDS, including COVID-19 ARDS. The closing of the agreement is subject to the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and certain other conditions.

    About COVID-19 Acute Respiratory Distress Syndrome (ARDS)

    ARDS is due to a dysregulated immune response in the lungs to various infectious agents including COVID-19. Deaths continue to increase in ventilator-dependent ARDS patients as COVID-19 cases continue to surge globally. Despite improved treatment and earlier intervention in hospitalized COVID-19 patients overall, the mortality rate in COVID-19 ARDS patients who are over 60 years old remains more than 60%.2 These patients appear to be particularly refractory to corticosteroids such as dexamethasone3,4 and have not responded to single cytokine antagonists, anti-virals, or anti-malaria agents.

    About Remestemcel-L

    Remestemcel-L is an investigational therapy comprising culture-expanded mesenchymal stromal cells derived from the bone marrow of an unrelated donor. Remestemcel-L is thought to have immunomodulatory properties to counteract the cytokine storms that are implicated in various inflammatory conditions by downregulating the production of pro-inflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues.

    About Mesoblast

    Mesoblast Limited (NASDAQ:MESO, ASX:MSB))) is a world leader in developing allogeneic (off-the-shelf) cellular medicines. The Company has leveraged its proprietary mesenchymal lineage cell therapy technology platform to establish a broad portfolio of commercial products and late-stage product candidates. Mesoblast has a strong and extensive global intellectual property portfolio with protection extending through to at least 2040 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. For more information, please see www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter: @Mesoblast

    References

    1.https://www.fda.gov/ForPatients/Approvals/Fast/ucm405399.htm

    2.Rezoagli E, Fumagalli R, Bellani G. 2017. Definition and epidemiology of acute respiratory distress syndrome. Ann Transl Med. 5(14): 1- 12

    3.Bellani G, Laffey J, Pham T. et. al. 2016. Epidemiology, patterns of care, and mortality for patients with acute respiratory distress syndrome in intensive care units in 50 countries. JAMA 315(8): 788-800

    4.https://www.hopkinsguides.com/hopkins/view/Johns_Hopkins_ABX_Guide/540747/all/Coronavirus_COVID_19__SARS_CoV_2

    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 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; 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 further information, please contact:

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    Julie Meldrum

    T: +61 3 9639 6036

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    T: +212 880 2060

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    Paul Hughes

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  2. NEW YORK, Nov. 19, 2020 (GLOBE NEWSWIRE) -- Mesoblast Limited (NASDAQ:MESO, ASX:MSB))), global leader in allogeneic cellular medicines for inflammatory diseases, today reported operational and financial results for the first quarter ended September 30, 2020 (FY2021).

    Mesoblast has entered into an exclusive worldwide license and collaboration agreement with Novartis for the development, manufacture and commercialization of its lead mesenchymal stromal cell (MSC) product candidate, remestemcel-L, with an initial focus on the treatment of acute respiratory distress syndrome (ARDS), including that associated with COVID-19. Details of this transaction have been lodged in a separate announcement with the ASX and Nasdaq today. 

    As foreshadowed…

    NEW YORK, Nov. 19, 2020 (GLOBE NEWSWIRE) -- Mesoblast Limited (NASDAQ:MESO, ASX:MSB))), global leader in allogeneic cellular medicines for inflammatory diseases, today reported operational and financial results for the first quarter ended September 30, 2020 (FY2021).

    Mesoblast has entered into an exclusive worldwide license and collaboration agreement with Novartis for the development, manufacture and commercialization of its lead mesenchymal stromal cell (MSC) product candidate, remestemcel-L, with an initial focus on the treatment of acute respiratory distress syndrome (ARDS), including that associated with COVID-19. Details of this transaction have been lodged in a separate announcement with the ASX and Nasdaq today. 

    As foreshadowed following the capital raising in May 2020, Mesoblast increased its investment in both clinical development and manufacturing to facilitate the potential availability of remestemcel-L for patients with COVID-19. These activities led to the strategic collaboration with Novartis which will open new opportunities in respiratory indications. This collaboration will also provide the commercial and manufacturing strength to bring this important cellular medicine to the many patients with COVID-19 and its life-threatening complication of ARDS.

    Cash on hand at September 30, 2020 was US$108.1 million (A$152.1 million)1 and, on transaction closing,2 pro-forma cash on hand is US$158.1 million (A$222.4 million).

    Remestemcel-L for COVID-19 Complications in Adults and Children

    As cases of COVID-19 surge in the United States and globally, deaths continue to increase from ARDS in ventilator-dependent patients as a result of an overactive immune response in the lungs to COVID-19. Remestemcel-L is being evaluated for its potential to reduce 30-day mortality on top of maximal care in a Phase 3 randomized controlled trial of up to 300 ventilator-dependent adults with moderate or severe COVID-19 ARDS. The key secondary endpoint is the number of days off mechanical ventilator support.

    After two prior interim analyses reviewing safety and efficacy data, the trial's independent Data Safety Monitoring Board (DSMB) recommended trial continuation as planned. Trial enrollment has now surpassed 180 patients.

    The trial aims to confirm pilot data where nine of 12 (75%) ventilator-dependent adult patients with COVID-19 ARDS who received two doses of remestemcel-L under emergency compassionate use at New York's Mt Sinai Hospital were successfully discharged within a median of 10 days.

    Children hospitalized with COVID-19 infection are at risk of a life-threatening inflammatory condition called multi-system inflammatory syndrome (MIS-C) which involves multiple critical organs and their vasculature, is associated with COVID-19 antibodies, and is thought to be a post-viral autoimmune process. In approximately 50% of cases this inflammation is associated with significant cardiovascular complications resulting in decreased heart function and dilation of coronary arteries.3-5 

    Mesoblast's existing Investigational New Drug (IND) application provides physicians with access to use remestemcel-L in COVID-19 infected children aged between two months and 17 years with MIS-C. 6 Two COVID-19 infected children with MIS-C who received remestemcel-L for severe heart failure fully recovered heart function and were discharged within 30 hours of the second dose.

    Remestemcel-L for Steroid-Refractory Acute Graft Versus Host Disease

    As part of the broad license and collaboration agreement with Novartis for remestemcel-L, Mesoblast will retain full rights and economics for graft versus host disease (GVHD). 

    On August 13, 2020, results from 309 children with steroid-refractory acute graft versus host disease (SR-aGVHD) treated with remestemcel-L were presented to the Oncologic Drugs Advisory Committee (ODAC) of the United States Food and Drug Administration (FDA). The ODAC panel voted 9:1 that the available data support the efficacy of remestemcel-L in pediatric patients with SR-aGVHD7. Despite the overwhelming ODAC vote, on September 30, the FDA provided Mesoblast with a Complete Response Letter.

    On November 17, a Type A meeting was held with the FDA to discuss the review of the Biologics License Application for remestemcel-L and a potential pathway for accelerated approval with a post-approval requirement to conduct an additional randomized controlled study in patients 12 years and older. At the current time it appears that the FDA review team will not agree to accelerated approval. However, the definitive outcome of the Type A meeting will not be known until Mesoblast receives the formal minutes which are expected within 30 days of the meeting. If the current review team does not agree to accelerated approval, Mesoblast will request a further Type A meeting to initiate the well-established FDA dispute resolution pathway.

    Under the terms of the license and collaboration agreement, Novartis has an option to become the commercial distributor for remestemcel-L in SR-aGVHD outside of Japan.

    Remestemcel-L for Inflammatory Bowel Disease

    A randomized, controlled study of remestemcel-L delivered by an endoscope directly to the areas of inflammation and tissue injury in up to 48 patients with medically refractory Crohn's or ulcerative colitis has commenced at Cleveland Clinic. Mesoblast's objective is to confirm the potential for remestemcel-L to induce luminal healing and early remission in a wider spectrum of diseases with severe inflammation of the gut, in addition to SR-aGVHD.

    Despite recent advances in the treatment of inflammatory bowel disease, approximately 30% of patients are primarily unresponsive to anti-TNFα agents and even among responders, up to 10% will lose their response to the drug every year. Up to 80% of patients with medically-refractory Crohn's disease eventually require surgical treatment of their disease,8 which can have a devastating impact on quality of life. This investigator-initiated study is the first in humans using local cell delivery directly into the gut, and will enable Mesoblast to compare clinical outcomes using this delivery method with results from an ongoing randomized, placebo-controlled trial in patients with biologic-refractory Crohn's disease where remestemcel-L was administered intravenously.

    Rexlemestrocel (REVASCOR®) for Advanced Chronic Heart Failure 

    In the United States alone, of more than 6.5 million patients with chronic heart failure, there are more than 1.3 million patients with advanced stage of the disease.9 The objective of treatment with Mesoblast's allogeneic cellular product candidate REVASCOR® is to reduce or reverse the severe inflammatory process in the damaged heart of these patients, and thereby prevent or delay further progression of heart failure or death.

    Mesoblast's randomized placebo-controlled Phase 3 trial in 566 patients with advanced forms of New York Heart Association Class II or Class III disease has completed patient follow-up and all events have been independently adjudicated. While the COVID-19 pandemic has delayed completion of data quality review at the study sites, the Phase 3 trial data readout is expected in the current quarter.

    In an earlier randomized placebo-controlled 60-patient Phase 2 trial, a single intra-myocardial injection of REVASCOR at the dose administered in the subsequent Phase 3 trial prevented any hospitalizations or deaths over three years of follow-up in patients with advanced chronic heart failure.

    Rexlemestrocel (MPC-06-ID) for Chronic Low Back Pain

    Mesoblast's MPC-06-ID development program targets over 3.2 million patients in the United States and 4 million in the E.U.5 with chronic low back pain due to moderate to severe inflammatory disc degeneration.10 There is a significant need for a safe, efficacious and durable treatment in patients with chronic low back pain due to severely inflamed degenerative disc disease.

    While the COVID-19 pandemic has delayed completion of data quality review at the study sites, data readout for the 2:1 randomized placebo-controlled US Phase 3 trial in 404 patients is expected in the current quarter.

    Mesoblast continues to collaborate closely with Grünenthal on the clinical protocol for a confirmatory Phase 3 trial in Europe for MPC-06-ID in chronic low back pain due to degenerative disc disease, with the results of this and the United States Phase 3 trial expected to support both FDA and European Medicines Agency regulatory approvals.

    Financial Results for the First Quarter Ended September 30, 2020 (FY2021)

    • Revenues decreased US$15.7 million to US$1.3 million for first quarter FY2021, compared to US$17.0 million for first quarter FY2020.



      • Milestone revenue decreased by US$15.0 million due to the upfront milestone payment of US$15.0 million received for the strategic partnership with Grünenthal GmbH in first quarter FY2020, compared to nil milestone income in first quarter FY2021.  

         
      • Royalty revenue on sales of TEMCELL HS Inj.(R)11 in Japan decreased US$0.6 million to US$1.3 million for first quarter FY2021 compared with US$1.9 million for first quarter FY2020. The decrease was due to a temporary shutdown in production as JCR expands its facility capacity to meet increasing demand far in excess of its initial forecast (as announced by JCR on July 31, 2020).



    • Research and Development expenses increased by US$6.9 million to US$19.3 million for first quarter FY2021, compared to US$12.4 million for the first quarter FY2020. This was due to increased clinical trial costs relating to the Phase 3 trial for COVID-19 ARDS, non-cash share-based payments to employees and consultants, and pre-commercial activities for remestemcel-L.

       
    • Manufacturing expenses increased by US$9.2 million to US$11.9 million for first quarter FY2021, compared to US$2.7 million for first quarter FY2020 due to increased expenditure on clinical supply for the COVID-19 ARDS Phase 3 trial and inventory for the potential launch of RYONCIL (remestemcel-L).  

       
    • Management and Administration expenses increased US$2.2 million to US$7.7 million for first quarter FY2021, compared with US$5.5 million for first quarter FY2020 primary due to non-cash share-based payments to employees and consultants and increased in other corporate overheads.

       
    • Finance Costs for borrowing arrangements with Hercules and NovaQuest were US$4.8 million for first quarter FY2021, compared to US$3.5 million for first quarter FY2020.             

    As a result of the above, loss after tax for the first quarter FY2021 was US$24.5 million compared to US$5.5 million for first quarter FY2020. The net loss attributable to ordinary shareholders was 4.21 US cents per share for first quarter FY2021, compared with 1.10 US cents per share for first quarter FY2020.

    Conference Call Details 

    There will be a webcast today on the financial results beginning at 9.00am AEDT (Friday, November 20); 5.00pm EST (Thursday, November 19, 2020). It can be accessed via https://webcast.boardroom.media/mesoblast-limited/20201119/NaN5fb59c68f297810019932232

    The archived webcast will be available on the Investor page of the Company's website: www.mesoblast.com

    References

    1.Cash on hand at September 30, 2020 has been translated from US$ to A$ at a spot rate of 1.407.

    2.The closing of the license agreement is subject to the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and certain other conditions. The pro-forma cash is inclusive of a US$25 million equity purchase at a 15% premium to the volume weighted average price calculated over 30 trading days as of today, subject to the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and certain other conditions.

    3.www.clinicaltrials.gov; NCT04456439 

    4.Lancet2020; May 7. DOI: https://doi.org/10.1016/S0140-6736(20)31094-12

    5.Lancet. 2020; (May 13) https://doi.org/10.1016/S0140-6736(20)31103-X

    6.https://www.nejm.org/doi/full/10.1056/NEJMoa2021756

    7.This vote includes a change to the original vote by one of the ODAC panel members after electronic voting closed.

    8.Crohn's and Colitis Foundation.

    9.AHA's 2017 Heart Disease and Stroke Statistics.

    10.Decision Resources: Chronic Pain December 2015.

    11.TEMCELL HS Inj.(R) is a registered trademark of JCR Pharmaceuticals Co. Ltd.

    About Mesoblast

    Mesoblast Limited (NASDAQ:MESO, ASX:MSB))) is a world leader in developing allogeneic (off-the-shelf) cellular medicines. The Company has leveraged its proprietary mesenchymal lineage cell therapy technology platform to establish a broad portfolio of commercial products and late-stage product candidates. Mesoblast has a strong and extensive global intellectual property (IP) portfolio with protection extending through to at least 2040 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. 

    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. Mesoblast is completing Phase 3 trials for its product candidates for advanced 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 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 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 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, 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 Board.

    For further information, please contact:

    Media

    Julie Meldrum

    T: +61 3 9639 6036

    E:  
     

    Kristen Bothwell

    T: +1 917 613 5434

    E:



     
    Investors

    Schond Greenway

    T: +212 880 2060

    E: 


    Paul Hughes   

    T: +61 3 9639 6036

    E:     



     





    Consolidated Income Statement

      Three Months Ended

    September 30,
     
    (in U.S. dollars, in thousands, except per share amount) 2020  2019 
    Revenue  1,305   17,048 
    Research & development  (19,278)  (12,389)
    Manufacturing commercialization  (11,924)  (2,698)
    Management and administration  (7,680)  (5,463)
    Fair value remeasurement of contingent consideration  15,107   (288)
    Other operating income and expenses  2,018   (169)
    Finance costs  (4,822)  (3,457)
    Loss before income tax  (25,274)  (7,416)
    Income tax benefit  730   1,932 
    Loss attributable to the owners of Mesoblast Limited  (24,544)  (5,484)
             
    Losses per share from continuing operations attributable to the ordinary equity holders of the Group: Cents  Cents 
    Basic - losses per share  (4.21)  (1.10)
    Diluted - losses per share  (4.21)  (1.10)





    Consolidated Statement of Comprehensive Income

      Three Months Ended

    September 30,
    (in U.S. dollars, in thousands) 2020  2019  
    Loss for the period  (24,544)  (5,484) 
    Other comprehensive (loss)/income         
    Items that may be reclassified to profit and loss         
    Financial assets at fair value through other comprehensive income  81   (365) 
    Exchange differences on translation of foreign operations  408   (332) 
    Other comprehensive (loss)/income for the period, net of tax  489   (697) 
    Total comprehensive losses attributable to the owners of Mesoblast Limited  (24,055)  (6,181) 





    Consolidated Balance Sheet

      As of

    September 30,
      As of

    June 30,
     
    (in U.S. dollars, in thousands) 2020  2020 
    Assets        
    Current Assets        
    Cash & cash equivalents  108,123   129,328 
    Trade & other receivables  2,446   1,574 
    Prepayments  5,168   5,646 
    Total Current Assets  115,737   136,548 
             
    Non-Current Assets        
    Property, plant and equipment  2,294   2,293 
    Right-of-use assets  8,038   7,978 
    Financial assets at fair value through other comprehensive income  1,952   1,871 
    Other non-current assets  3,334   3,311 
    Intangible assets  581,217   581,601 
    Total Non-Current Assets  596,835   597,054 
    Total Assets  712,572   733,602 
             
    Liabilities        
    Current Liabilities        
    Trade and other payables  27,602   24,972 
    Provisions  22,218   29,197 
    Borrowings  34,893   32,455 
    Lease liabilities  2,984   3,519 
    Total Current Liabilities  87,697   90,143 
             
    Non-Current Liabilities        
    Deferred tax liability     730 
    Provisions  20,723   27,563 
    Borrowings  56,098   57,023 
    Lease liabilities  7,048   6,317 
    Deferred consideration  2,500   2,500 
    Total Non-Current Liabilities  86,369   94,133 
    Total Liabilities  174,066   184,276 
    Net Assets  538,506   549,326 
             
    Equity        
    Issued Capital  1,063,005   1,051,450 
    Reserves  48,803   46,634 
    (Accumulated losses)/retained earnings  (573,302)  (548,758)
    Total Equity  538,506   549,326 





    Consolidated Statement of Cash Flows

      Three Months Ended

    September 30,
     
    (in U.S. dollars, in thousands) 2020  2019 
    Cash flows from operating activities        
    Commercialization revenue received  682   1,739 
    Upfront and milestone payments received      
    Government grants and tax incentives received  17   1,499 
    Payments to suppliers and employees (inclusive of goods and services tax)  (27,484)  (17,539)
    Interest received  13   173 
    Interest and other costs of finance paid  (1,389)  (1,427)
    Income taxes (paid)  (6)  (3)
    Net cash (outflows) in operating activities  (28,167)  (15,558)
             
    Cash flows from investing activities        
    Investment in fixed assets  (81)  (153)
    Payments for licenses     (100)
    Net cash (outflows) in investing activities  (81)  (253)
             
    Cash flows from financing activities        
    Proceeds from issue of shares  8,134   299 
    Payments for share issue costs  (897)   
    Payments for lease liabilities  (695)  (335)
    Net cash inflows by financing activities  6,542   (36)
             
    Net increase/(decrease) in cash and cash equivalents  (21,706)  (15,847)
    Cash and cash equivalents at beginning of period  129,328   50,426 
    FX gain/(losses) on the translation of foreign bank accounts  501   (43)
    Cash and cash equivalents at end of period  108,123   34,536 

     



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  3. NEW YORK, Nov. 19, 2020 (GLOBE NEWSWIRE) -- Mesoblast Limited (NASDAQ:MESO, ASX:MSB))), today announced that it has entered into an exclusive worldwide license and collaboration agreement with Novartis for the development, manufacture and commercialization of Mesoblast's mesenchymal stromal cell (MSC) product remestemcel-L, with an initial focus on the development of the treatment of acute respiratory distress syndrome (ARDS), including that associated with COVID-19.

    Mesoblast Chief Executive Dr Silviu Itescu stated: "Our collaboration with Novartis will help ensure that remestemcel-L could become available to the many patients suffering from ARDS, the principal cause of mortality in COVID-19 infection. This agreement is in line with our…

    NEW YORK, Nov. 19, 2020 (GLOBE NEWSWIRE) -- Mesoblast Limited (NASDAQ:MESO, ASX:MSB))), today announced that it has entered into an exclusive worldwide license and collaboration agreement with Novartis for the development, manufacture and commercialization of Mesoblast's mesenchymal stromal cell (MSC) product remestemcel-L, with an initial focus on the development of the treatment of acute respiratory distress syndrome (ARDS), including that associated with COVID-19.

    Mesoblast Chief Executive Dr Silviu Itescu stated: "Our collaboration with Novartis will help ensure that remestemcel-L could become available to the many patients suffering from ARDS, the principal cause of mortality in COVID-19 infection. This agreement is in line with our corporate strategy to collaborate and partner with world-leading major pharma companies in order to maximize market access for our innovative cellular medicines."

    The demonstrated ability of Novartis to rapidly move from clinical to commercial scale with cell-based therapies will play a role in the successful development and potential commercialization of remestemcel-L, as will the nearly two decades of experience Novartis has in delivering first-in-class products that address areas of unmet respiratory need.

    ARDS is an area of significant unmet need, with a high mortality rate despite current standard of care, which includes prolonged ICU treatment and mechanical ventilation. As the potential first ARDS therapy, remestemcel-L will be evaluated to treat this deadly condition and improve outcomes. Remestemcel-L is currently being studied in COVID-19-related ARDS in an ongoing 300-patient Phase 3 study, where even with maximal existing therapies, mortality is estimated to be even higher. Novartis intends to initiate a Phase 3 study in non-COVID-19-related ARDS after the anticipated closing of the license agreement and successful completion and outcome of the current study.

    Key transaction terms:

    • Novartis will make a US$50 million upfront payment including US$25 million in equity.

       
    • From the initiation of a Phase 3 trial in all-cause ARDS, Novartis will fully fund global clinical development for all-cause ARDS and potentially other respiratory indications. 

       
    • Mesoblast may receive a total of US$505 million pending achievement of pre-commercialization milestones for ARDS indications.

       
    • Mesoblast may receive additional payments post-commercialization of up to US$750 million based on achieving certain sales milestones and tiered double-digit royalties on product sales.

       
    • Mesoblast will retain full rights and economics for remestemcel-L for graft versus host disease (GVHD), and Novartis has an option to, if exercised, become the commercial distributor outside of Japan.

       
    • For most non-respiratory indications, the parties may co-fund development and commercialization on a 50:50 profit-share basis. 

       
    • Mesoblast will be responsible for clinical and commercial manufacturing and Novartis will purchase commercial product under agreed pricing terms. Novartis will reimburse Mesoblast up to US$50 million on the achievement of certain milestones related to the successful implementation of its next-generation manufacturing processes using its proprietary media and three-dimensional bioreactors aimed at delivering substantial manufacturing efficiencies. Novartis will be responsible for any capital expenditure required to meet increased capacity requirements for manufacture of remestemcel-L.

    The closing of the license agreement is subject to the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and certain other conditions.

    About Mesenchymal Stromal Cells (MSCs)

    MSCs have immunomodulatory properties which may facilitate their effective use in life-threatening conditions associated with systemic inflammation. Key inherent characteristics of MSCs are their capacity for significant expansion in culture and their relative lack of immunogenicity. These properties facilitate their use as allogeneic or "off-the-shelf" therapeutics with specific release criteria and batch-to-batch reproducibility.

    About Remestemcel-L

    Remestemcel-L is an investigational therapy comprising culture-expanded MSCs derived from the bone marrow of an unrelated donor. Remestemcel-L is thought to have immunomodulatory properties to counteract the cytokine storms that are implicated in various inflammatory conditions 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. Remestemcel-L is being developed for inflammatory diseases in children and adults including steroid-refractory acute graft versus host disease (SR-aGVHD) and moderate to severe acute respiratory distress syndrome.

    About Mesoblast

    Mesoblast Limited (NASDAQ:MESO, ASX:MSB))) is a world leader in developing allogeneic (off-the-shelf) cellular medicines. The Company has leveraged its proprietary mesenchymal lineage cell therapy technology platform to establish a broad portfolio of commercial products and late-stage product candidates. Mesoblast has a strong and extensive global intellectual property (IP) portfolio with protection extending through to at least 2040 in all major markets. The Company's proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with specific release criteria, are planned to be readily available to patients worldwide.

    Mesoblast is developing remestemcel-L for various inflammatory conditions, including SR-aGVHD and COVID-19 ARDS, and rexlemestrocel-L for advanced 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 globally and in Europe and China for certain 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

    Conference Call

    There will be a webcast today beginning at 9.00am AEDT (Friday, November 20); 5.00pm EST (Thursday, November 19, 2020). It can be accessed via https://webcast.boardroom.media/mesoblast-limited/20201119/NaN5fb59c68f297810019932232

    The archived webcast will be available on the Investor page of the Company's website: www.mesoblast.com

    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 potential milestone and royalty payments that may be received pursuant to the agreement with Novartis, 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, 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 Board.

    For further information, please contact:

    Media

    Julie Meldrum

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    Kristen Bothwell

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    E:

      
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    T: +212 880 2060

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    Paul Hughes   

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  4. NEW YORK, Nov. 19, 2020 (GLOBE NEWSWIRE) -- Mesoblast Limited (NASDAQ:MESO, ASX:MSB))), global leader in allogeneic cellular medicines for inflammatory diseases, will host a webcast today to provide a corporate update, and report financial and operational highlights for the first quarter ended September 30, 2020 (FY2021).

    Conference Call Details 
    The webcast will begin at 9.00am AEDT, Friday, November 20; 5.00pm EST, Thursday, November 19, 2020. It can be accessed via https://webcast.boardroom.media/mesoblast-limited/20201119/NaN5fb59c68f297810019932232

    The archived webcast will be available on the Investor page of the Company's website: www.mesoblast.com

    About Mesoblast
    Mesoblast Limited (NASDAQ:MESO, ASX:MSB))) is a world leader in…

    NEW YORK, Nov. 19, 2020 (GLOBE NEWSWIRE) -- Mesoblast Limited (NASDAQ:MESO, ASX:MSB))), global leader in allogeneic cellular medicines for inflammatory diseases, will host a webcast today to provide a corporate update, and report financial and operational highlights for the first quarter ended September 30, 2020 (FY2021).

    Conference Call Details 

    The webcast will begin at 9.00am AEDT, Friday, November 20; 5.00pm EST, Thursday, November 19, 2020. It can be accessed via https://webcast.boardroom.media/mesoblast-limited/20201119/NaN5fb59c68f297810019932232

    The archived webcast will be available on the Investor page of the Company's website: www.mesoblast.com

    About Mesoblast

    Mesoblast Limited (NASDAQ:MESO, ASX:MSB))) is a world leader in developing allogeneic (off-the-shelf) cellular medicines. The Company has leveraged its proprietary mesenchymal lineage cell therapy technology platform to establish a broad portfolio of commercial products and late-stage product candidates. Mesoblast has a strong and extensive global intellectual property (IP) portfolio with protection extending through to at least 2040 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. 

    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. Mesoblast is completing Phase 3 trials for its product candidates for advanced 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 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

    Release authorized by the Chief Executive.

    For further information, please contact:

    Media

    Julie Meldrum

    T: +61 3 9639 6036

    E:
    Kristen Bothwell

    T: +1 917 613 5434

    E:
      
    Investors

    Schond Greenway

    T: +212 880 2060

    E: 
    Paul Hughes   

    T: +61 3 9639 6036

    E:  



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  5. NEW YORK, Nov. 11, 2020 (GLOBE NEWSWIRE) -- Mesoblast Limited (NASDAQ:MESO, ASX: MSB))) today announced that the randomized controlled Phase 3 trial of remestemcel-L in patients with moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19 infection had received a recommendation to continue from the independent Data Safety Monitoring Board (DSMB) following completion of the trial's second interim analysis. The analysis was performed on the trial's first 135 patients, 45% of the total target of up to 300 randomized patients, with the DSMB recommending continuation after reviewing the trial's primary endpoint, all-cause mortality within 30 days of randomization and all safety data. The key secondary endpoint is days alive…

    NEW YORK, Nov. 11, 2020 (GLOBE NEWSWIRE) -- Mesoblast Limited (NASDAQ:MESO, ASX: MSB))) today announced that the randomized controlled Phase 3 trial of remestemcel-L in patients with moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19 infection had received a recommendation to continue from the independent Data Safety Monitoring Board (DSMB) following completion of the trial's second interim analysis. The analysis was performed on the trial's first 135 patients, 45% of the total target of up to 300 randomized patients, with the DSMB recommending continuation after reviewing the trial's primary endpoint, all-cause mortality within 30 days of randomization and all safety data. The key secondary endpoint is days alive off mechanical ventilatory support within 60 days of randomization.

    Mesoblast Chief Medical Officer Dr Fred Grossman said: "We are very pleased with the recommendation by the DSMB, as we seek to confirm whether remestemcel-L improves survival in ventilated COVID-19 patients with moderate to severe ARDS. Patients who have co-morbidities or are older are likely to continue to be at high risk of ARDS and death,1-3 even if COVID-19 vaccines become available. This is why having a potential treatment that reduces mortality in these patients is so important."

    ARDS is the principal cause of death in COVID-19 infection and is thought to be due to a dysregulated immune response in the lungs to COVID-19. Deaths continue to increase in ventilator-dependent ARDS patients as COVID-19 cases continue to surge globally. Despite improved treatment and earlier intervention in hospitalized COVID-19 patients overall, the mortality rate in COVID-19 ARDS patients who are over 60 years old remains more than 60%.1 These patients appear to be particularly refractory to corticosteroids such as dexamethasone 4-5 and have not responded to single cytokine antagonists, anti-virals, or anti-malaria agents. 

    The Phase 3 trial aims to confirm findings from a pilot study at New York's Mt Sinai Hospital in March-April this year where nine of 12 ventilator-dependent patients (75%) were successfully discharged from hospital a median of 10 days after receiving two intravenous doses of remestemcel-L within five days. The ongoing Phase 3 trial, which is treating patients across more than 20 hospitals in the United States, uses the same dosing regimen.

    Mesoblast holds an Investigational New Drug (IND) submission for remestemcel-L in COVID-19 ARDS, with trial size, protocol design, and endpoints developed with input from the United States Food and Drug Administration. The third and final interim analysis, when 60% of the randomized target has completed 30 days of follow-up, will occur in the coming weeks.

    References

    1. Mortality of COVID-19 Admitted Patients on Mechanical Ventilators. Epic Health Research Network. June 26, 2020
    2. Harrison SL., et al. Comorbidities associated with mortality in 31,461 adults with COVID-19 in the United States: A federated electronic medical record analysis. PLOS Medicine. September 10, 2020. https://doi.org/10.1371/journal.pmed.1003321
    3. Sanyaolu A., et al. Comorbidity and its Impact on Patients with COVID-19. SN Compr Clin Med. 2020 Jun 25: 1-8. doi: 10.1007/s42399-020-00363-4
    4. Dexamethasone in Hospitalized Patients with Covid-19 — Preliminary Report. New England Journel of Medicine. July 17, 2020. DOI: 10.1056/NEJMoa2021436
    5. Tomazini BM., et.al. Effect of Dexamethasone on Days Alive and Ventilator-Free in Patients With Moderate or Severe Acute Respiratory Distress Syndrome and COVID-19. JAMA 2020;324(13):1307-1316.

    About Remestemcel-L

    Mesoblast's lead product candidate, remestemcel-L, is an investigational therapy comprising culture-expanded mesenchymal stem cells derived from the bone marrow of an unrelated donor. It is thought to have immunomodulatory properties to counteract the cytokine storms that are implicated in various inflammatory conditions 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.

    About Mesoblast

    Mesoblast Limited (NASDAQ:MESO, ASX:MSB))) is a world leader in developing allogeneic (off-the-shelf) cellular medicines. The Company has leveraged its proprietary mesenchymal lineage cell therapy technology platform to establish a broad portfolio of commercial products and late-stage product candidates. Mesoblast has a strong and extensive global intellectual property (IP) portfolio with protection extending through to at least 2040 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. 

    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. Mesoblast is completing Phase 3 trials for its product candidates for advanced 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 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 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 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; 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 further information, please contact:

    Media

    Julie Meldrum

    T: +61 3 9639 6036

    E:





    Kristen Bothwell

    T: +1 917 613 5434

    E:

    Investors

    Schond Greenway

    T: +212 880 2060

    E: 


    Paul Hughes

    T: +61 3 9639 6036

    E: 

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