Mesoblast Limited · ASX:MSB
Mesoblast — Investor Presentation (December 2023)
53 slides from Mesoblast's investor presentation, Dec 4, 2023
Slide 1: Capital Raising Presentation
mesoblast Global Leader in Allogeneic Cellular Medicines for Inflammatory Diseases Capital Raising Presentation 1 for 4 Accelerated Non-Renounceable Entitlement Offer together with an Institutional Placement 4 December 2023 ASX: MSB; Nasdaq: MESO Not for release to US wire services or distribution i
Slide 2: Important Notice and Disclaimer
Important Notice and Disclaimer This presentation has been prepared by Mesoblast Limited (ACN 68 109 431 870) (Mesoblast or Company) in relation to an accelerated non-renounceable pro-rata entitlement offer (Entitlement Offer) of new fully paid ordinary shares in Mesoblast (New Shares), and a placem
Slide 3: Important Notice and Disclaimer
Important Notice and Disclaimer This Presentation has been prepared for publication in Australia and may not be released or distributed in the United States. In particular, this Presentation does not constitute an offer to sell, or a solicitation of an offer to buy, securities in the United States.
Slide 4: Important Notice and Disclaimer
Important Notice and Disclaimer Mesoblast, its advisers and their respective related bodies corporate, affiliates, directors, employees or agents assume no responsibility for the accuracy of such information. Any market and industry data used in connection with this Presentation was obtained from rese
Slide 5: Offer Summary
Offer Summary 1 for 4 pro-rata accelerated non-renounceable Entitlement Offer together with a Placement to raise up to A$97.0 million before costs through Structure and size (“The Offer”) issuing approximately 323.4 million new shares (39.7% of current issued capital) Offer Price of A$0.30 per New S
Slide 6: Financials and Use of Proceeds
Financials and Use of Proceeds Cash balance at September 30, 2023 was US$53.2 million, with net operating cash spend of US$14.2 million for the quarter. Management and the Board have put in place a plan that focuses on preservation of cash by implementing significant cost containment strategies and
Slide 7: Pro Forma Balance Sheet US$m
Pro Forma Balance Sheet US$m 30 June 2023(1) 30 June 2023(2) (audited) Pro forma Cash and cash equivalents 71.3 132.9 Other assets 598.1 598.1 Total Assets 669.4 731.0 Current liabilities 42.0 42.0 Non-current liabilities 125.6 125.6 Total Liabilities 167.6 167.6 Issued Capital 1,249.1 1,310.7 Reser
Slide 8: Indicative Offer Timetable
Indicative Offer Timetable Event Date Announcement of the Offer 4 December 2023 Placement and Institutional Entitlement Offer opens 4 December 2023 Placement and Institutional Entitlement Offer closes 4 December 2023 Trading halt lifted and Mesoblast shares recommence trading on ASX 5 December 2023
Slide 9: Our Mission
Our Mission Mesoblast is committed to bringing to market innovative cellular medicines to treat serious and life-threatening illnesses Not for release to US wire services or distribution in the United States Not for release to US wire services or distribution in the United States
Slide 10: Corporate Vision
Corporate Vision To be world’s leading, most innovative, and highly respected cellular medicines company To use our proprietary technologies to develop cellular medicine products that are life-saving and that improve quality of life To establish an organization that attracts motivated people working
Slide 11: Investment Highlights
Investment Highlights Developing off-the-shelf, allogeneic cellular medicines based on proprietary Novel Allogeneic mesenchymal stromal cell (MSC) technology platforms to enable treatment without the Cell Therapy Platform need for donor matching or immunosuppression Single-arm pivotal Phase 3 trial
Slide 12: Corporate Level Strategic Options Evaluated and Set
Corporate Level Strategic Options Evaluated and Set Preferred Strategic Options Strategy Partner AND Develop 1 Develop All on Own 2 Partner All indications 3 carveouts 4 Sell Indications ✓ Potential immediate financial rewards through partnership ✓ Diminished development and commercial costs if part
Slide 13: Tactical Execution Of Corporate Strategy
Tactical Execution Of Corporate Strategy Intellectual Go to market Capital Direct versus Partnership Our Patents & Advancing our our People Clinical Pipeline Building a Strong Brand Securing a Manufacturing Robust Strategy for Product Delineation Financial Base and Life-Cycle 13 mesoblast
Slide 14: Setting Key Strategic Priorities for 2024
Setting Key Strategic Priorities for 2024 ▪ Additional potency assay data, provide to FDA Seeking first regulatory approval in the US ▪ Commence adult SR-aGVHD Phase 3 trial ▪ Continue to seek pediatric SR-aGVHD approval and launch Further advancement of ▪ Enrollment of CLBP second Phase 3 trial MPC
Slide 15: Global Intellectual Property (IP) Estate
Global Intellectual Property (IP) Estate Provides Substantial Competitive Advantage Extensive patent portfolio with protection extending through 2040 Over 1,100 patents and patent applications (82 patent families) Markets across all major jurisdictions Global coverage including U.S., Europe, China,
Slide 16: Commercial-scale Manufacturing Process and Facilities
Commercial-scale Manufacturing Process and Facilities Scalable allogeneic “off-the-shelf” cellular platforms Manufacturing Remestemcel-L Manufacturing meets stringent criteria of international regulatory agencies Robust quality assurance processes ensure final product with batch-to-batch consistency
Slide 17: Platform Technology – Shared Mechanism of Action Across Our Products
Platform Technology – Shared Mechanism of Action Across Our Products Our mesenchymal precursor/stromal cells respond to and are activated by multiple inflammatory cytokines through surface receptors, resulting in orchestration of an anti-inflammatory cascade IL-10 Breg TH1 Proliferation Proliferatio
Slide 18: Late-Stage Clinical Pipeline
Late-Stage Clinical Pipeline Based on the Proprietary Allogeneic Mesenchymal Stromal Cell Platform Product Indication Phase 2 Phase 3 Regulatory Filing Approved Pediatric Remestemcel-L SR-aGVHD Adult Remestemcel-L SR-aGVHD Crohn’s Rexlemestrocel-L CLBP SR-aGVHD = Steroid-Refractory Acute Graft Versu
Slide 19: Clinical Program Milestones - Next 12 Months
Clinical Program Milestones - Next 12 Months Target Date Status • Currently finalizing additional potency assay data on commercial Q1 CY2024 In progress RYONCIL inventory to provide to FDA Adult & Pediatric • Planned meeting with the FDA regarding potency assay data for the Q1 CY2024 Planned SR-aGVH
Slide 20: Pathway to Approval for RYONCIL in Pediatric Patients with SR-aGVHD
Pathway to Approval for RYONCIL in Pediatric Patients with SR-aGVHD During the Biologics License Application (BLA) review Mesoblast made substantial progress towards bringing this cutting-edge product to market with a completed FDA inspection of our manufacturing process. In August FDA provided a co
Slide 21: Pathway to Approval for RYONCIL in Adult Patients with SR-aGVHD
Pathway to Approval for RYONCIL in Adult Patients with SR-aGVHD Survival in adults with SR-aGVHD who have failed at least one additional agent, such as ruxolitinib, remains as low as 20-30% by 100 days, a patient population with no approved therapies.1,2 In contrast, 100-day survival was 63% after r
Slide 22: Financial Highlights
Financial Highlights Revenue from royalties, predominantly on sales of TEMCELL® HS Inj.1 sold in Japan by our licensee, were US$7.5 million for the year ended June 30, 2023. Cash balance at September 30, 2023 was US$53.2 million, with net operating cash spend of US$14.2 million for the quarter. Mana
Slide 23: Chronic Low Back Pain due to Degenerative Disc Disease (CLBP)
Chronic Low Back Pain due to Degenerative Disc Disease (CLBP) 23 Not for release to US wire services or distribution in the United States mesoblast
Slide 24: Chronic Low Back Pain Due to Degenerative Disc Disease (CLBP) Impacts 7M+
Chronic Low Back Pain Due to Degenerative Disc Disease (CLBP) Impacts 7M+ Rexlemestrocel-L represents a potential new paradigm for the treatment of CLBP Burden of Illness Treatment Options Market Opportunity Back pain causes more Minimal treatment options Over 7m patients are disability than any oth
Slide 25: Rexlemestrocel-L / CLBP – Program Summary
Rexlemestrocel-L / CLBP – Program Summary Regulatory Alignment Phase 3 Protocol Product Manufacturing Pivotal P3 Trial Gained alignment with FDA has agreed with Product has been RMAT designation for the FDA on the Mesoblast plans for manufactured for use in CLBP received from FDA appropriate pivotal
Slide 26: RMAT Designation Granted by FDA for Rexlemestrocel-L in CLBP
Regenerative Medicine Advanced Therapy (RMAT) Designation Granted by FDA for Rexlemestrocel-L in the treatment of CLBP RMAT designation provides all the benefits of Breakthrough and Fast Track designations, including rolling review and eligibility for priority review on filing of a Biologics License
Slide 27: Phase 3 Trial Outcomes based on a Single Injection of Rexlemestrocel-L + HA
Phase 3 Trial Outcomes based on a Single Injection of Rexlemestrocel-L + HA Results in More than Three Years of Pain Reduction Greatest pain reduction was observed in the pre-specified population of subjects with CLBP duration shorter than the baseline study median of 68 months (n=202) with signific
Slide 28: Chronic Heart Failure Reduced Ejection Fraction (HFrEF)
Chronic Heart Failure Reduced Ejection Fraction (HFrEF) 28 Not for release to US wire services or distribution in the United States mesoblast
Slide 29: Rexlemestrocel-L / HFrEF – Program Summary
Rexlemestrocel-L / HFrEF – Program Summary Defining the Regulatory Path to FDA Approval Significant Need Promising Data Targeting Inflammation FDA Meeting Cardiovascular disease Recent data from the Effects on LVEF and MACE Mesoblast plans to meet remains the leading DREAM-HF P3 trial outcomes are e
Slide 30: Patients Experience Progressive Vascular Dysfunction and Heart Failure
Patients Experience Progressive Vascular Dysfunction and Heart Failure Rexlemestrocel-L has the potential to improve endothelial dysfunction in patients from Class II thru IV Mesoblast’s Development Programs DREAM HF-1 Trial LVAD MPC Studies 537 Patients 189 Patients Early Guideline Directed Medical
Slide 31: Randomized Trial of Targeted Transendocardial Mesenchymal Precursor Cell Therapy
ORIGINAL INVESTIGATIONS Randomized Trial of Targeted Transendocardial Mesenchymal Perin EC, Borow KM, Henry TD, et al. Randomized Trial of Targeted Transendocardial Mesenchymal Precursor Cell Therapy in Patients With Heart Failure. Journal of the Precursor Cell Therapy in Patients American College o
Slide 32: Rexlemestrocel-L – Two Pivotal Studies in Chronic Heart Failure (CHF)
Rexlemestrocel-L – Two Pivotal Studies in Chronic Heart Failure (CHF) Mesoblast’s Development Programs Assess the Impact of Intra-cardiac Administration of Rexlemestrocel-L Across the Continuum of Disease from Mild/Moderate to End-stage Severity MPC Study Design LVAD-MPC Study #2 DREAM-HF Trial Trea
Slide 33: REVASCOR As Treatment For Severe Congenital Heart Disease
REVASCOR As Treatment For Severe Congenital Heart Disease Filed with FDA For Orphan Drug And Pediatric Rare Disease Designations Hypoplastic left heart syndrome (HLHS) is a severe congenital Anatomy of hypoplastic left heart syndrome heart disease in which the left side of the heart does not fully d
Slide 34: REVASCOR As Treatment For Severe Congenital Heart Disease
REVASCOR As Treatment For Severe Congenital Heart Disease Filed with FDA For Orphan Drug And Pediatric Rare Disease Designations In the HLHS randomized controlled single-center US trial in 19 patients, a single intramyocardial administration of REVASCOR at the time of staged surgery resulted in sign
Slide 35: Steroid-Refractory Acute Graft Versus Host Disease (SR-aGVHD)
Steroid-Refractory Acute Graft Versus Host Disease (SR-aGVHD) 35 Not for release to US wire services or distribution in the United States mesoblast
Slide 36: Acute Graft Versus Host Disease (aGVHD)
Acute Graft Versus Host Disease (aGVHD) Serious and Fatal Complication of Allogeneic Bone Marrow Transplantation (BMT) PHASE 1 PHASE 2 PHASE 3 Host Tissue Damage Immune Cell Activation Inflammation and End Organ by BMT Conditioning & Cytokine Storm Damage Conditioning regimen, Activation of CD4 & CD
Slide 37: Remestemcel-L: Steroid-Refractory Acute Graft Versus Host Disease
Remestemcel-L: Steroid-Refractory Acute Graft Versus Host Disease (SR-aGVHD) SR-aGVHD is associated with mortality rates as high as 90% Treatment Options Burden of Illness Market Opportunity Corticosteroids are first-line Acute GVHD is a life- More than 30,000 therapy for aGVHD threatening complicat
Slide 38: Remestemcel-L for Children with SR-aGVHD
Remestemcel-L for Children with SR-aGVHD Improved Early Survival Across Three Studies involving more than 300 Treated Children Day 100 Survival Remestemcel-L Protocol Remestemcel-L Matched Controls Matched Control Protocol First Line Therapy after Steroids Treatment Setting Pediatric Subset of Proto
Slide 39: Extended Survival Data in Children with SR-aGVHD
Extended Survival Data in Children with SR-aGVHD Remestemcel-L Treatment Resulted in Durable Survival Over 4 Years Survival Outcomes in Pediatric & Adult SR-aGVHD (Remestemcel-L data from the Center for International Blood and Marrow Transplant Research (CIBMTR) dbase) Study GVHD001 MacMillan et al1
Slide 40: Pathway to Approval for RYONCIL in Pediatric Patients with SR-aGVHD
Pathway to Approval for RYONCIL in Pediatric Patients with SR-aGVHD During the Biologics License Application (BLA) review we made substantial progress towards bringing this cutting-edge product to market with a completed FDA inspection of our manufacturing process. In August the FDA provided a compl
Slide 41: RYONCIL for Adults with SR-aGVHD
RYONCIL for Adults with SR-aGVHD Commercial strategy is to progress to adults who have failed steroids and a first-line agent, including ruxolitinib Market opportunity approximately five times larger than pediatric Approximately 45% of ruxolitinib patients are non-responders 1 Survival in adults wit
Slide 42: Appendix
Not for release to US wire services or distribution in the United States 42 mesoblast
Slide 43: Key Risks (1 of 5)
Key Risks (1 of 5) Risk type Outline FINANCIAL The Company has incurred operating losses since its inception and anticipates that it will continue to incur substantial operating losses for the foreseeable future. It is POSITION AND currently unclear whether the Company will ever achieve or sustain p
Slide 44: Key Risks (2 of 5)
Key Risks (2 of 5) Risk type Outline COLLABORATORS The Company relies heavily on third parties (e.g. pharmaceutical companies) (collaborators) to develop and/or commercialise the Company’s current and future product candidates. The failure of collaborators to carry out their contractual duties, meet
Slide 45: Key Risks (3 of 5)
Key Risks (3 of 5) Risk type Outline MANUFACTURING RISK The Company has no experience manufacturing its product candidates at a commercial scale. It may not be able to manufacture product candidates in quantities sufficient for development and commercialization if the product candidates are approved
Slide 46: Key Risks (4 of 5)
Key Risks (4 of 5) Risk type Outline COMMERCIALISATION RISK Future commercial success depends upon attaining significant market acceptance of product candidates, if approved, among physicians, patients and healthcare payors. The market acceptance of each of product candidates is volatile and depends
Slide 47: Key Risks (5 of 5)
Key Risks (5 of 5) Risk type Outline INDUSTRY RISK The Company conducts operations in multiple tax jurisdictions. The laws of those jurisdictions generally require that the transfer pricing between affiliated companies in different jurisdictions be the same as those between unrelated companies deali
Slide 48: mesoblast
48 Not for release to US wire services or distribution in the United States mesoblast
Slide 49: International Offer Restrictions
International Offer Restrictions Bahamas This document has not been, and will not be, registered as a preliminary prospectus or a prospectus under the Securities Industry Act, 2011 of the Commonwealth of The Bahamas. The information in this document is intended solely for the designated recipient. I
Slide 50: International Offer Restrictions
International Offer Restrictions Liechtenstein This document has not been, and will not be, registered with or approved by the Financial Market Authority of Liechtenstein. Accordingly, this document may not be made available, nor may the New Shares be offered for sale, in Liechtenstein except in cir
Slide 51: International Offer Restrictions
International Offer Restrictions Norway This document has not been approved by, or registered with, any Norwegian securities regulator under the Norwegian Securities Trading Act of 29 June 2007 no. 75. Accordingly, this document shall not be deemed to constitute an offer to the public in Norway with
Slide 52: International Offer Restrictions
International Offer Restrictions United Kingdom Neither this document nor any other document relating to the offer has been delivered for approval to the Financial Conduct Authority in the United Kingdom and no prospectus (within the meaning of section 85 of the Financial Services and Markets Act 20
Slide 53: Thank You
mesoblast Thank You 53 mesoblast Not for release to US wire services or distribution in the United States