mesoblast Global Leader in Allogeneic Cellular Medicines for Inflammatory Diseases Operational Highlights & Financial Results for the Year Ended June 30, 2022 August 2022 ASX: MSB; Nasdaq: MESO CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This presentation 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 achieve ...

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 Filed in the month of June 2022 for the period ended March 31, 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 Executi ...

PART I [Key Information](index=7&type=section&id=Item%203.%20Key%20Information) This section outlines significant financial, clinical, regulatory, and operational risks, emphasizing historical losses and the need for additional funding [Risk Factors](index=7&type=section&id=3.D%20Risk%20Factors) This section details numerous financial, developmental, regulatory, manufacturing, commercialization, and intellectual property risks facing the company - The company incurred operating losses since inception, with a **net loss of $98.8 million** in FY2021 and an **accumulated deficit of $647.6 million**[25](index=25&type=chunk) - Mesoblast requires substantial additional financing to achieve its goals, with cash and cash equivalents at **$136.9 million** as of June 30, 2021[30](index=30&type=chunk) - Product candidates are based on novel mesenchymal lineage cell technology, making development time, cost, and regulatory approval difficult to predict[40](index=40&type=chunk) - The FDA issued a Complete Response Letter for remestemcel-L for pediatric SR-aGVHD in September 2020, recommending at least one additional randomized, controlled study[82](index=82&type=chunk) - The company relies on a single contract manufacturer, Lonza, for product candidate supply, entailing risks related to capacity, quality, and regulatory compliance[101](index=101&type=chunk)[108](index=108&type=chunk) [Information on the Company](index=42&type=section&id=Item%204.%20Information%20on%20the%20Company) This section provides a comprehensive overview of Mesoblast's history, business strategy, technology platforms, product candidates, and regulatory environment [History and Development of Mesoblast](index=42&type=section&id=4.A%20History%20and%20Development%20of%20Mesoblast) This section outlines Mesoblast's corporate history, key clinical and corporate developments, and strategic agreements during fiscal year 2021 - Successfully completed a **$110.0 million private placement** in March 2021, led by a strategic US investor group[217](index=217&type=chunk) - Announced top-line results from the DREAM-HF Phase 3 trial of rexlemestrocel-L in 537 patients with advanced chronic heart failure in December 2020[217](index=217&type=chunk) - Announced results from the Phase 3 trial of rexlemestrocel-L in 404 patients with chronic low back pain due to degenerative disc disease in January 2021[217](index=217&type=chunk) - Entered into a license and collaboration agreement with Novartis in November 2020 for remestemcel-L, initially focusing on ARDS, subject to closing conditions[220](index=220&type=chunk) - Received a Complete Response Letter from the FDA for the Biologics License Application (BLA) for RYONCIL™ (remestemcel-L) in pediatric SR-aGVHD in September 2020, recommending an additional study[221](index=221&type=chunk) [Business Overview](index=45&type=section&id=4.B%20Business%20Overview) Mesoblast's business focuses on proprietary mesenchymal lineage cell therapy, developing off-the-shelf medicines for inflammatory and chronic diseases - Mesoblast developed two late-stage product candidate platforms: Remestemcel-L for systemic inflammatory diseases and Rexlemestrocel-L for localized inflammatory diseases[225](index=225&type=chunk) - The company's technology uses immuno-selected, culture-expanded mesenchymal precursor cells (MPCs) and their progeny, MSCs, sourced from healthy adult donors and administered without matching[227](index=227&type=chunk)[228](index=228&type=chunk) - Two licensee products, TEMCELL (JCR in Japan) and Alofisel® (Takeda in Europe), have been approved, generating royalty income for Mesoblast[235](index=235&type=chunk)[236](index=236&type=chunk)[237](index=237&type=chunk) - The company holds a large patent portfolio with **approximately 1,089 patents and patent applications** across 77 patent families as of July 2021[289](index=289&type=chunk) [Property, Plants and Equipment](index=67&type=section&id=4.D%20Property,%20Plants%20and%20Equipment) The company leases office and laboratory space in key global locations, with all manufacturing operations conducted by its partner, Lonza - Headquarters are located in leased office space in Melbourne, Australia[397](index=397&type=chunk) - Significant development and commercial activities are conducted from leased space in New York City[397](index=397&type=chunk) - All manufacturing operations are currently located at Lonza's manufacturing facilities[397](index=397&type=chunk) [Operating and Financial Review and Prospects](index=68&type=section&id=Item%205.%20Operating%20and%20Financial%20Review%20and%20Prospects) This section details Mesoblast's FY2021 financial performance, including revenue decline, increased net loss, liquidity, and capital resources [Operating Results](index=68&type=section&id=5.A%20Operating%20Results) FY2021 saw a 77% revenue decrease to $7.5 million and a 27% net loss increase to $98.8 million, driven by non-recurring milestone payments Consolidated Income Statement Data (FY2021 vs. FY2020) | (in thousands of U.S. dollars) | 2021 | 2020 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | **Total revenue** | **$7,456** | **$32,156** | **($24,700)** | **(77%)** | | Research & development | ($53,012) | ($56,188) | $3,176 | (6%) | | Manufacturing commercialization | ($32,719) | ($25,309) | ($7,410) | 29% | | Management and administration | ($30,867) | ($25,609) | ($5,258) | 21% | | Fair value remeasurement of contingent consideration | $18,687 | $1,380 | $17,307 | NM | | Finance costs | ($10,714) | ($14,109) | $3,395 | (24%) | | **Loss before income tax** | **($99,630)** | **($87,355)** | **($12,275)** | **14%** | | Income tax benefit | $819 | $9,415 | ($8,596) | (91%) | | **Loss attributable to owners** | **($98,811)** | **($77,940)** | **($20,871)** | **27%** | - Revenue decrease was primarily due to the absence of **$25.0 million in milestone revenue** in FY2021 from partnerships with Grünenthal and Tasly[420](index=420&type=chunk)[422](index=422&type=chunk) - Commercialization revenue from royalties on sales of TEMCELL in Japan and Alofisel® in Europe increased by **12% to $7.4 million**[421](index=421&type=chunk) - Manufacturing commercialization expenses increased by **$7.4 million (29%)** due to investment in manufacturing readiness for remestemcel-L and potency assay work[431](index=431&type=chunk)[432](index=432&type=chunk) - A fair value remeasurement of contingent consideration resulted in an **$18.7 million gain**, primarily due to revised assumptions following the FDA's Complete Response Letter for remestemcel-L[438](index=438&type=chunk) [Liquidity and Capital Resources](index=78&type=section&id=5.B%20Liquidity%20and%20Capital%20Resources) As of June 30, 2021, Mesoblast held $136.9 million in cash, facing material uncertainty regarding going concern without additional financing - The company's ability to continue as a going concern is dependent on raising additional capital through partnerships or financing, indicating a material uncertainty[478](index=478&type=chunk) Cash and Cash Equivalents | (in thousands of U.S. dollars) | As of June 30, 2021 | | :--- | :--- | | Cash and cash equivalents | $136,881 | Cash Flow Summary (FY2021 vs. FY2020) | (in thousands of U.S. dollars) | 2021 | 2020 | | :--- | :--- | :--- | | Net cash (outflows) in operating activities | (106,681) | (56,365) | | Net cash (outflows) in investing activities | (1,647) | (3,273) | | Net cash inflows by financing activities | 114,466 | 137,044 | | **Net increase in cash and cash equivalents** | **6,138** | **77,406** | - The company has two main loan facilities: **$50.0 million drawn** with Hercules Capital and **$30.0 million drawn** with NovaQuest Capital Management, both with specific covenants[491](index=491&type=chunk)[495](index=495&type=chunk)[502](index=502&type=chunk) [Directors, Senior Management and Employees](index=82&type=section&id=Item%206.%20Directors,%20Senior%20Management%20and%20Employees) This section details the company's leadership, executive compensation strategy, employee demographics, and share ownership by key management personnel [Directors and Senior Management](index=84&type=section&id=6.A%20Directors%20and%20Senior%20Management) The company is led by an experienced Board of Directors and senior management team, including CEO Dr. Silviu Itescu and former CFO Josh Muntner - The Board of Directors is chaired by Joseph Swedish and includes members with significant experience from major pharmaceutical and healthcare companies[524](index=524&type=chunk)[525](index=525&type=chunk)[526](index=526&type=chunk) - Dr. Silviu Itescu serves as the Chief Executive Officer and Executive Director, having founded the company in 2004[537](index=537&type=chunk) - Josh Muntner served as Chief Financial Officer for FY2021 but resigned effective August 31, 2021, with Andrew Chaponnel appointed interim CFO[523](index=523&type=chunk)[538](index=538&type=chunk)[539](index=539&type=chunk) [Compensation](index=91&type=section&id=6.B%20Compensation) The executive remuneration strategy links pay to performance, with a shift towards long-term, performance-based incentives to align with shareholder value - The remuneration framework was significantly changed to reduce cash costs and increase the weighting of long-term, performance-tested options to align executive and shareholder interests[514](index=514&type=chunk) - For FY2021, the CEO's Short-Term Incentive (STI) outcome was **65% of the maximum opportunity**, and the CFO's was **60%**, reflecting mixed objective achievement[513](index=513&type=chunk)[581](index=581&type=chunk) - No Long-Term Incentive (LTI) option tranches became eligible to vest for the CEO in FY2021, as the targeted FDA approval of remestemcel-L did not occur[585](index=585&type=chunk) Statutory Remuneration for Executive KMP (FY2021) | Name | Currency | Base salary | Short term cash bonus | Share based payments | Total Statutory Remuneration | % of performance based remuneration | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Silviu Itescu | A$ | 1,010,000 | 328,250 | 1,207,365 | 2,661,876 | 58% | | Josh Muntner | US$ | 382,000 | 159,771 | 302,898 | 885,900 | 52% | [Employees](index=114&type=section&id=6.D%20Employees) As of June 30, 2021, Mesoblast had 83 global employees, a decrease from the prior year, with the majority based in the United States Employee Count by Year | As of June 30, | 2021 | 2020 | 2019 | | :--- | :--- | :--- | :--- | | **Total Employees** | **83** | **102** | **83** | - In FY2021, **58% of employees** were in the USA, **30%** in Australia, **11%** in Singapore, and **1%** in Switzerland[636](index=636&type=chunk) [Share Ownership](index=115&type=section&id=6.E%20Share%20Ownership) CEO Dr. Silviu Itescu is the largest individual shareholder among KMP, collectively owning 11.4% of outstanding ordinary shares - CEO Silviu Itescu beneficially owned **69,991,374 ordinary shares**, representing **10.8% of the company** as of June 30, 2021[666](index=666&type=chunk)[667](index=667&type=chunk) - All directors and key management personnel as a group (9 persons) beneficially owned **74,250,295 ordinary shares**, representing **11.4% of the company**[666](index=666&type=chunk) [Major Shareholders and Related Party Transactions](index=116&type=section&id=Item%207.%20Major%20Shareholders%20and%20Related%20Party%20Transactions) This section identifies major shareholders and confirms no related party transactions beyond standard compensation for directors and key management personnel 5% or Greater Shareholders (as of June 30, 2021) | Name | Ordinary Shares Beneficially Owned | % | | :--- | :--- | :--- | | Silviu Itescu | 69,991,374 | 10.8% | | M&G Investment Group | 53,392,209 | 8.2% | | Thorney Holdings | 34,155,365 | 5.3% | - The company has not entered into any related party transactions during the year ended June 30, 2021, other than compensation for Directors and key management personnel[671](index=671&type=chunk) [Financial Information](index=117&type=section&id=Item%208.%20Financial%20Information) This section covers legal proceedings, including a class action lawsuit, and the company's policy of not paying dividends to fund growth - A purported class action lawsuit was filed against the company in the U.S. in October 2020, alleging violations of the U.S. Securities Exchange Act of 1934 following the FDA's Complete Response Letter[673](index=673&type=chunk) - The company has never declared or paid any dividends and does not anticipate paying cash dividends in the foreseeable future, intending to retain all funds for operations and growth[674](index=674&type=chunk) [Additional Information](index=118&type=section&id=Item%2010.%20Additional%20Information) This section provides supplementary corporate information, including material contracts, exchange controls, and taxation relevant to shareholders [Material Contracts](index=123&type=section&id=10.C%20Material%20Contracts) Mesoblast's material contracts include manufacturing agreements with Lonza, commercialization partnerships, and significant non-dilutive loan agreements - **Manufacturing:** Agreements with Lonza for process development and commercial manufacture of product candidates, including remestemcel-L[720](index=720&type=chunk)[725](index=725&type=chunk) - **Grünenthal Partnership:** Strategic partnership to develop and commercialize MPC-06-ID in Europe and Latin America, with **potential milestone payments exceeding $1.0 billion**[727](index=727&type=chunk)[728](index=728&type=chunk) - **JCR Pharmaceuticals Partnership:** Collaboration for MSC products in the Japanese market, including TEMCELL for aGVHD, which generates royalty revenue for Mesoblast[730](index=730&type=chunk)[732](index=732&type=chunk) - **Financing Agreements:** A **$75.0 million credit facility** with Hercules Capital and a **$40.0 million loan agreement** with NovaQuest, secured by company assets and future product revenues, respectively[737](index=737&type=chunk)[739](index=739&type=chunk) PART II [Controls and Procedures](index=136&type=section&id=Item%2015.%20Controls%20and%20Procedures) Management concluded that disclosure controls and internal control over financial reporting were effective as of June 30, 2021 - The Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective as of June 30, 2021[823](index=823&type=chunk) - Management concluded that its internal control over financial reporting was effective as of June 30, 2021, based on the COSO framework[824](index=824&type=chunk) - There were no changes to internal control over financial reporting during the period that materially affected, or are reasonably likely to materially affect, internal controls[825](index=825&type=chunk) [Corporate Governance](index=137&type=section&id=Item%2016G.%20Corporate%20Governance) As a foreign private issuer, Mesoblast follows Australian corporate governance practices for shareholder meeting quorums instead of Nasdaq rules - As a foreign private issuer, Mesoblast is permitted to follow certain home country (Australian) corporate governance practices instead of certain Nasdaq requirements[834](index=834&type=chunk) - The company follows Australian practice for shareholder meeting quorums, requiring two shareholders present, rather than the Nasdaq rule of at least **33 1/3% of outstanding shares**[836](index=836&type=chunk) PART III [Financial Statements](index=138&type=section&id=Item%2018.%20Financial%20Statements) This section presents audited IFRS financial statements for FY2021, with the auditor highlighting a material uncertainty regarding going concern [Report of Independent Registered Public Accounting Firm](index=139&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) The auditor's report expresses substantial doubt about going concern and identifies impairment assessment and contingent consideration as critical audit matters - **Going Concern Uncertainty:** The auditor's report highlights a material uncertainty raising substantial doubt about the company's ability to continue as a going concern, noting the need for additional cash inflows[844](index=844&type=chunk) - **Critical Audit Matter 1:** The impairment assessment of in-process research and development (IPRD) intangible assets (**$427.8 million**) and goodwill (**$134.5 million**) involved significant management judgments regarding future cash flow projections and probabilities of success[852](index=852&type=chunk)[853](index=853&type=chunk) - **Critical Audit Matter 2:** The fair value measurement of the provision for contingent consideration (**$25.4 million**) was a critical audit matter due to significant management judgments in estimating its value, particularly regarding probabilities of success[855](index=855&type=chunk)[856](index=856&type=chunk) [Consolidated Financial Statements](index=143&type=section&id=Consolidated%20Financial%20Statements) FY2021 consolidated financial statements show a $98.8 million net loss, $7.5 million revenue, and $136.9 million cash, with going concern uncertainty Key Financial Statement Figures (as of June 30, 2021) | (in thousands of U.S. dollars) | Amount | | :--- | :--- | | **Income Statement (FY2021):** | | | Total Revenue | $7,456 | | Loss before income tax | ($99,630) | | Net Loss | ($98,811) | | **Balance Sheet:** | | | Cash & cash equivalents | $136,881 | | Intangible assets | $580,546 | | Total Assets | $744,717 | | Borrowings | $94,245 | | Total Liabilities | $163,320 | | Total Equity | $581,397 | - The company's ability to continue as a going concern is noted as a basis of preparation, with management believing it can secure necessary cash inflows despite the material uncertainty[875](index=875&type=chunk) - As of June 30, 2021, pre-launch inventory of **$21.9 million** was recognized on the balance sheet but fully provided for, with costs expensed within Manufacturing Commercialization expenses[1146](index=1146&type=chunk)

WASHINGTON, D.C. 20549 FORM 20-F ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended June 30, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of even ...

Financial Data and Key Metrics Changes - Total revenue grew nearly 100% to $32.2 million from $16.7 million for the fiscal year ended June 30, 2020 [29][30] - Milestone revenue from strategic partnerships increased by 127% to $25 million from $11 million [30] - Commercialization revenue from JCR Pharmaceuticals rose by 32% to $6.6 million from $5 million [31] - Loss after tax reduced by 13%, driven by increased revenue and reduced clinical trial spending [32] Business Line Data and Key Metrics Changes - RYONCIL, the lead product candidate, is under FDA review for pediatric steroid-refractory acute GVHD, with a PDUFA date set for September 30, 2020 [8][21] - Ongoing Phase 3 trials for remestemcel in acute respiratory distress syndrome from COVID-19, heart failure, and chronic low back pain [9][12][73] - Revenue from JCR Pharmaceuticals for TEMCELL, a product for acute GVHD, is expected to be impacted by production capacity issues [34][36] Market Data and Key Metrics Changes - The addressable U.S. market for acute GVHD in children and adults is approximately eight times larger than in Japan [36] - Pediatric transplants account for about 25% of all bone marrow transplants in the U.S., indicating a significant market opportunity [92] Company Strategy and Development Direction - The company plans to launch RYONCIL in Q4 2020 if approved, with a focus on both pediatric and adult markets for GVHD [21][52] - A lifecycle strategy for remestemcel includes plans for adult steroid-refractory GVHD and COVID-19 ARDS [55][60] - The company is enhancing manufacturing capabilities to meet anticipated demand and is exploring strategic partnerships for commercialization [68] Management's Comments on Operating Environment and Future Outlook - Management highlighted the transformational potential of the upcoming months for the company, emphasizing the importance of RYONCIL's approval [5] - The company is actively engaging with payers regarding pricing and reimbursement strategies for RYONCIL [90] - Management expressed confidence in the demand for RYONCIL based on the experience with TEMCELL in Japan [91] Other Important Information - Cash on hand as of June 30, 2020, was $129.3 million, with an additional $67.5 million potentially available through strategic partnerships [38][39] - The company has a robust patent portfolio with over 1,100 patents and applications, providing strong global protection [18] Q&A Session Summary Question: How should the company model fiscal year 2021? - Management indicated that sales progression for RYONCIL will depend on payer agreements and pricing discussions, with insights drawn from the TEMCELL experience in Japan [90][91] Question: What is the expected year-over-year increase for R&D and SG&A? - Management noted that some costs currently categorized under R&D will shift to SG&A as sales revenue begins [97][99] Question: What was the average age of treated patients in the RYONCIL trial? - The mean age of treated patients was between five and seven, with the label expected to extend up to 18 years [105][106] Question: What is the expected impact of JCR's production and backlog on fiscal 2021 revenues? - Management referenced JCR's guidance indicating a potential drop in TEMCELL sales due to COVID-19, affecting projected royalties [108] Question: Will Grunenthal's Phase 3 trial depend on the company's Phase 3 readout? - Management clarified that the second trial's design will be informed by the totality of data from the current trial, indicating ongoing discussions with regulators [111]

olast Global Leader in Allogeneic Cellular Medicines for Inflammatory Diseases Financial Year Ended June 30, 2020 ASX: MSB; Nasdaq: MESO CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This presentation 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, level ...

Mesoblast Ltd (NASDAQ:MESO) Q4 2020 Earnings Conference Call May 27, 2020 6:00 PM ET Corporate Participants Silviu Itescu - CEO Josh Muntner - CFO Fred Grossman - CMO Conference Call Participants Louise Chen - Cantor Jeffrey Cohen - Ladenburg Thalmann Jason Folger - Dawson James Securities Tanushree Jain - Bell Potter Securities Operator Hello, and welcome to the financial results for the period ended March 31, 2020, and corporate update for Mesoblast. An announcement and presentation has been lodged with t ...

Global Leader in Allogeneic Cellular Medicines for Inflammatory Diseases Financial and Operational Highlights for the Third Quarter Ended March 31, 2020 ASX: MSB; Nasdaq: MESO CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This presentation 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 ma ...

Financial Data and Key Metrics Changes - Overall revenue grew 43% to $19.2 million from $13.5 million in the previous period [14] - Commercialization revenue from TEMCELL royalty increased 73% to $3.8 million from $2.2 million [14] - Milestone revenue from strategic partnerships rose 36% to $15 million from $11 million [14] - Loss after tax reduced by 32%, driven by increased revenue and a 22% decline in R&D expenses [15] Business Line Data and Key Metrics Changes - TEMCELL royalties contributed significantly to revenue growth, reflecting strong product adoption in Japan [9] - The company has two Phase 3 product candidates targeting heart failure and back pain, with trial readouts expected this year [5][8] Market Data and Key Metrics Changes - The U.S. addressable market for steroid-refractory acute graft versus host disease is anticipated to be approximately 8 times larger than in Japan [9] - The market opportunity for Ryoncil in acute graft versus host disease is substantial, with high mortality rates in severe cases [18] Company Strategy and Development Direction - The company completed the BLA filing for Ryoncil for treating steroid-refractory acute graft versus host disease in children, with plans for a U.S. launch in 2020 [6][20] - A lifecycle expansion strategy is in place for remestemcel-L, targeting additional indications including chronic graft versus host disease and biologic-refractory Crohn's disease [8][20] - Strategic partnerships are being established for product development and commercialization in various regions, including Europe and Latin America [10][28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming U.S. launch of Ryoncil and the potential for sequential approval in Europe [34] - The company is optimistic about the Phase 3 trial outcomes for Revascor in heart failure, citing previous positive data from Phase 2 trials [35][36] - The management highlighted the importance of addressing the significant unmet needs in heart failure and chronic lower back pain markets [22][27] Other Important Information - The company has established manufacturing capabilities that meet international regulatory standards, ensuring product consistency and scalability [11] - The intellectual property estate includes over 1,000 patents, providing strong protection for the company's core commercial focus [10] Q&A Session Summary Question: What is the go-to-market strategy for Ryoncil in the U.S. and plans for Europe? - The company plans to target pediatric transplants in 15 centers in the U.S. with a small, efficient sales force and has established a relationship with Lonza for manufacturing [34] Question: What data supports a positive outcome for Revascor in the upcoming Phase 3 trial? - Previous Phase 2 trials showed a clear dose response and significant impact on reducing hospitalizations and mortality, providing confidence for the Phase 3 trial [35][36] Question: What is the expected timeline for the pivotal trial for chronic GVHD? - The company is still finalizing the number of patients and sites for the trial, with a focus on severe cases where existing therapies are least effective [39] Question: How many sales representatives will be on the ground for the U.S. launch? - The company is looking at a sales force of approximately 12 to 15 representatives [40] Question: What are the expectations for expenses over the next 12 to 24 months? - Overall cash burn is expected to decrease, with some resources shifting towards the commercial team and pre-launch inventory [59]

Mesoblast Limited (NASDAQ:MESO) Q1 2020 Earnings Conference Call November 25, 2019 4:30 PM ET Company Participants Silviu Itescu - Chief Executive Officer and Managing Director Josh Muntner - Chief Financial Officer Conference Call Participants Louise Chen - Cantor Fitzgerald Jeffrey Cohen - Ladenburg Thalmann Tanushree Jain - Bell Potter Securities Operator Hello, and welcome to Mesoblast???s Financial Results Webcast for the Quarter Ended September 30, 2019. An announcement and slide presentation have bee ...