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APPENDIX 4C QUARTERLY ACTIVITY REPORT Mesoblast Operational and Financial Highlights for Quarter Ended

Key Takeaway: APPENDIX 4C QUARTERLY ACTIVITY REPORT Mesoblast Operational and Financial Highlights for Quarter Ended June 30, 2021 Melbourne, Australia; July 30 and New York, USA; July 29, 2021: Mesoblast Limited (ASX:MSB; Nasdaq:MESO), global leader in allogeneic cellular medicines for infl

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APPENDIX 4C QUARTERLY ACTIVITY REPORT
Mesoblast Operational and Financial Highlights for Quarter Ended June 30, 2021
Melbourne, Australia; July 30 and New York, USA; July 29, 2021: Mesoblast Limited (ASX:MSB; Nasdaq:MESO), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an update on its pipeline of late-stage product candidates, and an activity report for the fourth quarter ended June 30, 2021.
"During the quarter we made significant progress in both regulatory and clinical outcomes for our lead product candidate, remestemcel-L. FDA's CBER has recently recommended the next steps in the potential approval pathway for remestemcel-L in the treatment of steroid-refractory acute graft versus host disease in children" said Silviu Itescu, Chief Executive of Mesoblast. "Additionally, as COVID infections continue to surge, the 90-day survival outcomes from the remestemcel-L trial in adults with COVID ARDS demonstrated the potential for durable benefit of this therapy in certain segments experiencing the most extreme complication of this disease."
Key operational highlights:
Cash Flow Report for the Fourth Quarter FY2021
Cash on hand at the end of the quarter was US$136.4 million.
Total Operating Activities resulted in net cash usage of US$20.7 million in the quarter ended June 30, 2021. This included an investment of US$10.8 million associated with remestemcel-L for SR-aGVHD and COVID-19 ARDS. Specifically:
A copy of the Appendix 4C - Quarterly Cash Flow Report for the fourth quarter FY2021 is attached.
About the Trial of Remestemcel-L in Acute Respiratory Distress Syndrome (ARDS) due to
The trial enrolled 222 mechanically ventilated COVID-19 patients with moderate/severe ARDS across the US, of whom 217 were randomized 1:1 and received either standard of care alone or standard of care plus 2 intravenous infusions of remestemcel-L at a dose of 2 million cells/kg 3-5 days apart. This was the same remestemcel-L dosing regimen used in the earlier compassionate use program where 11 of 12 patients were younger than 65 and 75% successfully came off ventilatory support.
The trial was halted in December 2020 after the Data Safety Monitoring Board (DSMB) performed a third interim analysis on the trial's first 180 patients, noting that the trial was not likely to meet the 30-day mortality reduction endpoint at the planned 300 patient enrolment. The trial was powered to achieve a primary endpoint of 43% reduction in mortality at 30 days for treatment with remestemcel-L on top of maximal care. The DSMB recommended that the trial complete with the enrolled 222 patients, and that all be followed-up as planned.
At follow-up through day 60, remestemcel-L reduced overall mortality by 14% across the entire population of treated patients (n=217), and by 46% in the pre-specified population of patients under age 65 (n=123). In an exploratory analysis through day 60, remestemcel-L reduced mortality by 75% and increased days alive off mechanical ventilation in patients under age 65 when combined with dexamethasone, in comparison with controls on dexamethasone.
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 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.
Mesoblast has completed Phase 3 trials of rexlemestrocel-L for advanced chronic heart failure and chronic low back pain. Remestemcel-L is being developed for inflammatory diseases in children and adults including steroid refractory acute graft versus host disease and moderate to severe acute respiratory distress syndrome. Two products have been commercialized in Japan and Europe by Mesoblast's licensees, and the Company has established commercial partnerships in Europe and China for certain Phase 3 assets.
Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter: @Mesoblast
References / Footnotes
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 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
Kristen Bothwell
T: +1 917 613 5434
E: kbothwell@rubenstein.com
Quarterly cash flow report for entities
subject to Listing Rule 4.7B
Name of entity
Mesoblast Limited
ABN Quarter ended ("current quarter")
68 109 431 870 30 June 2021
Consolidated statement of cash flows Current quarter $US'000 Year to date (12 months) $US'000
1. Cash flows from operating activities
1.1 Receipts from customers
- royalty receipts 1,959 6,121
1.2 Payments for
(a) research and development (5,900) (41,084)
(b) manufacturing commercialization (3,346) (14,324)
(c) product manufacturing and operating costs (4,729) (17,868)
(d) advertising and marketing (352) (6,175)
(e) leased assets - -
(f) staff costs (2,161) (10,241)
(g) other expenses from ordinary activities (3,787) (14,305)
(h) other: - Intellectual property portfolio expenses (616) (2,923)
1.3 Dividends received (see note 3) - -
1.4 Interest received - 17
1.5 Interest and other costs of finance paid (1,810) (5,932)
1.6 Income taxes paid - (35)
1.7 Government grants and tax incentives 12 68
1.8 Other (provide details if material) - -
1.9 Net cash from / (used in) operating activities (20,730) (106,681)
ASX Listing Rules Appendix 4C (17/07/20)Page 1
+ See chapter 19 of the ASX Listing Rules for defined terms.
Quarterly cash flow report for entities subject to Listing Rule 4.7B
Consolidated statement of cash flows Current quarter $US'000 Year to date (12 months) $US'000
2. Cash flows from investing activities - -
2.1 Payments to acquire or for:
(i) entities
(j) businesses - -
(k) property, plant and equipment (223) (1,647)
(l) investments - -
(m) intellectual property - -
(n) other non-current assets - -
2.2 Proceeds from disposal of: - -
(o) entities
(p) businesses - -
(q) property, plant and equipment - -
(r) investments - -
(s) intellectual property - -
(t) other non-current assets - -
2.3 Cash flows from loans to other entities - -
2.4 Dividends received (see note 3) - -
2.5 Other - -
2.6 Net cash from / (used in) investing activities (223) (1,647)
3. Cash flows from financing activities - 110,014
3.1 Proceeds from issues of equity securities (excluding convertible debt securities)
3.2 Proceeds from issue of convertible debt securities - -
3.3 Proceeds from exercise of options 684 9,223
3.4 Transaction costs related to issues of equity securities or convertible debt securities (280) (1,827)
3.5 Proceeds from borrowings - -
3.6 Repayment of borrowings - -
3.7 Transaction costs related to loans and borrowings - (13)
3.8 Dividends paid - -
ASX Listing Rules Appendix 4C (17/07/20)Page 2
+ See chapter 19 of the ASX Listing Rules for defined terms.
Quarterly cash flow report for entities subject to Listing Rule 4.7B
Consolidated statement of cash flows Current quarter $US'000 Year to date (12 months) $US'000
3.9 Other (payment of lease liability) (831) (2,931)
3.10 Net cash from / (used in) financing activities (427) 114,466
4. Net increase / (decrease) in cash and cash equivalents for the period 158,263 129,328
4.1 Cash and cash equivalents at beginning of quarter (April 1, 2021)/beginning of year (July 1, 2020)
4.2 Net cash from / (used in) operating activities (item 1.9 above) (20,730) (106,681)
4.3 Net cash from / (used in) investing activities (item 2.6 above) (223) (1,647)
4.4 Net cash from / (used in) financing activities (item 3.10 above) (427) 114,466
4.5 Effect of movement in exchange rates on cash held (2) 1,415
4.6 Cash and cash equivalents at end of period 136,881 136,881
5. Reconciliation of cash and cash equivalents at the end of the quarter (as shown in the consolidated statement of cash flows) to the related items in the accounts Current quarter $US'000 Previous quarter $US'000
5.1 Bank balances 136,430 157,807
5.2 Call deposits - -
5.3 Bank overdrafts - -
5.4 Other (Term deposits) 451 456
5.5 Cash and cash equivalents at end of quarter (should equal item 4.6 above) 136,881 158,263
ASX Listing Rules Appendix 4C (17/07/20)Page 3
+ See chapter 19 of the ASX Listing Rules for defined terms.
Quarterly cash flow report for entities subject to Listing Rule 4.7B
6. Payments to related parties of the entity and their associates Current quarter $US'000
6.1 Aggregate amount of payments to related parties and their associates included in item 1 643
6.2 Aggregate amount of payments to related parties and their associates included in item 2 -
Note: if any amounts are shown in items 6.1 or 6.2, your quarterly activity report must include a description of, and an explanation for, such payments.
Payments for Non-executive Director fees and Executive Director's salary (for the current quarter) = US$643,000
ASX Listing Rules Appendix 4C (17/07/20)Page 4
+ See chapter 19 of the ASX Listing Rules for defined terms.
Quarterly cash flow report for entities subject to Listing Rule 4.7B
7. Financing facilities Note: the term "facility' includes all forms of financing arrangements available to the entity. Add notes as necessary for an understanding of the sources of finance available to the entity. Total facility amount at quarter end $US'000 Amount drawn at quarter end $US'000
7.1 Loan facilities 90,000* 80,000*
7.2 Credit standby arrangements - -
7.3 Other (please specify) - -
7.4 Total financing facilities 90,000* 80,000*
7.5 Unused financing facilities available at quarter end 10,000*
7.6 Include in the box below a description of each facility above, including the lender, interest rate, maturity date and whether it is secured or unsecured. If any additional financing facilities have been entered into or are proposed to be entered into after quarter end, include a note providing details of those facilities as well.
* Loan facility with Hercules Capital, Inc. On March 6, 2018, Mesoblast entered into a Loan and Security Agreement with Hercules Capital, Inc. ("Hercules Capital") for a US$75.0 million secured four-year credit facility. Mesoblast drew the first tranche of US$35.0 million on closing. An additional US$15.0 million was drawn during Q1 CY2019. As at June 30, 2021 the interest rate on the loan was 9.70%. *Loan facility with NovaQuest Capital Management, L.L.C. On June 29, 2018, Mesoblast entered into a Loan and Security Agreement with NovaQuest Capital Management, L.L.C. ("NovaQuest") for a non-dilutive US$40.0 million secured eight-year term loan. Mesoblast drew the first tranche of US$30.0 million of the loan on closing. An additional US$10.0 million from the loan will be drawn on marketing approval of RYONCIL by the United States Food and Drug Administration (FDA). Prior to maturity in July 2026, the loan is only repayable from net sales of RYONCIL in the treatment of pediatric patients who have failed to respond to steroid treatment for acute Graft versus Host Disease (aGvHD), in the United States and other geographies excluding Asia. Interest on the loan will accrue at a rate of 15% per annum with the interest only period lasting 4 years. Interest payments will be deferred until after the first commercial sale. The financing is subordinated to the senior creditor, Hercules Capital.
ASX Listing Rules Appendix 4C (17/07/20)Page 5
+ See chapter 19 of the ASX Listing Rules for defined terms.
Quarterly cash flow report for entities subject to Listing Rule 4.7B
8. Estimated cash available for future operating activities $US'000
8.1 Net cash from / (used in) operating activities (item 1.9) (20,730)
8.2 Cash and cash equivalents at quarter end (item 4.6) 136,881
8.3 Unused finance facilities available at quarter end (item 7.5) 10,000*
8.4 Total available funding (item 8.2 + item 8.3) 146,881
8.5 Estimated quarters of funding available (item 8.4 divided by item 8.1) 7.1
Note: if the entity has reported positive net operating cash flows in item 1.9, answer item 8.5 as "N/A". Otherwise, a figure for the estimated quarters of funding available must be included in item 8.5. * Under the NovaQuest loan facility, an additional US$10.0 million from the loan will be drawn on marketing approval of RYONCIL by the United States Food and Drug Administration (FDA).
8.6 If item 8.5 is less than 2 quarters, please provide answers to the following questions:
8.6.1Does the entity expect that it will continue to have the current level of net operating cash flows for the time being and, if not, why not?
Answer: Not applicable
8.6.2Has the entity taken any steps, or does it propose to take any steps, to raise further cash to fund its operations and, if so, what are those steps and how likely does it believe that they will be successful?
Answer: Not applicable
8.6.3Does the entity expect to be able to continue its operations and to meet its business objectives and, if so, on what basis?
Answer: Not applicable
Note: where item 8.5 is less than 2 quarters, all of questions 8.6.1, 8.6.2 and 8.6.3 above must be answered.
Compliance statement
Date:.......30 July 2021...........................................................................
Authorised by: ......Chief Executive.............................................................................
(Name of body or officer authorising release - see note 4)
ASX Listing Rules Appendix 4C (17/07/20)Page 6
+ See chapter 19 of the ASX Listing Rules for defined terms.
Quarterly cash flow report for entities subject to Listing Rule 4.7B
ASX Listing Rules Appendix 4C (17/07/20)Page 7
+ See chapter 19 of the ASX Listing Rules for defined terms.
Last updated: Aug 3, 2021