MESOBLAST LTD — Investor Presentation 2021

Jul 15, 2021

meso blast the regenerative medicine company Top-line Results for Remestemcel-L in COVID-19 ARDS 2021 Stem Cells, Cell Therapies, and Bioengineering in Lung Biology and Diseases

JULY 2021 ASX: MSB; Nasdaq: MESO

==> picture [250 x 518] intentionally omitted <==

==> picture [152 x 158] intentionally omitted <==

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, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forwardlooking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. All statements other than statements of historical facts contained in this presentation are forward-looking statements. Words such as, but not limited to, “believe,” “expect,” “anticipate,” “estimate,” “intend,” “plan,” “targets,” “likely,” “will,” “would,” “could,” and similar expressions or phrases identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and future events , recent changes in regulatory laws, and financial trends that we believe may affect our financial condition, results of operation, business strategy and financial needs. These statements may relate to, but are not limited to: expectations regarding the safety or efficacy of, or potential applications for, Mesoblast's adult stem cell technologies; expectations regarding the strength of Mesoblast's intellectual property, the timeline for Mesoblast's regulatory approval process, and the scalability and efficiency of manufacturing processes; expectations about Mesoblast's ability to grow its business and statements regarding its relationships with current and potential future business partners and future benefits of those relationships; statements concerning Mesoblast's share price or potential market capitalization; and statements concerning Mesoblast's capital requirements and ability to raise future capital, among others. 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. You should read this presentation together with our financial statements and the notes related thereto, as well as the 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, include, without limitation: risks inherent in the development and commercialization of potential products; uncertainty of clinical trial results or regulatory approvals or clearances; government regulation; the need for future capital; dependence upon collaborators; and protection of our intellectual property rights, among others. 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.

Our Mission

Mesoblast is committed to bringing to market innovative cellular medicines to treat serious and life-threatening illnesses

==> picture [414 x 420] intentionally omitted <==

Platform Technology – Mechanism of Action (MOA)

Our mesenchymal stromal cells respond to and are activated by multiple inflammatory cytokines through surface receptors, resulting in orchestration of an anti-inflammatory cascade

==> picture [85 x 88] intentionally omitted <==

==> picture [658 x 350] intentionally omitted <==

----- Start of picture text -----

IL-10 Breg
TH1
Proliferation
Proliferation Mesenchymal Cytokine secretion
Effector Stromal Cell
Antibody production B cell TH17 Cytotoxicity
Activation IDO, PGE2
Cytotoxicity NK
TGF 𝛽 , M-CSF, CCL2
Treg IL-10
Maturation
Activation Immature DC
Antigen Presentation IL-1
IL-6 M1 M2 IL-10
Polarize
TNFα
M1 to M2
----- End of picture text -----

Source: Data on file

| 4

==> picture [931 x 470] intentionally omitted <==

----- Start of picture text -----

Acute Graft versus Host Disease (GVHD): A Prototypic Disease Driven by Cytokine Storm
PHASE 1 PHASE 2 PHASE 3
Host Tissue Damage Immune Cell Activation Inflammation and End Organ
by BMT Conditioning & Cytokine Storm Damage
Activation of
Conditioning
Macrophage
regimen, Tissue CD4 & CD8
input to cytokine
chemotherapy, or Damage T-cells
storm
radiation
Macrophage
Cytokine Storm
TNF, IL-1, IL-6
IFNγ, IL-2, IL-12, IL-21, IL-22, IL-23
Modified from Blazar et al., Nature Reviews Immunology 12: 443 – 458
----- End of picture text -----

| 5

Remestemcel-L in Steroid Refractory Acute GVHD: Clinical Evidence for a MOA Applicable to Various Inflammatory Conditions

Consistent efficacy and safety outcomes in a total of 309 children from three studies:

==> picture [85 x 88] intentionally omitted <==

• Remestemcel-L was used as first-line therapy in a randomized controlled Phase 3 trial of 260 patients, with SRaGVHD, including 27 children

• Remestemcel-L was used as salvage therapy in an expanded access program in 241 children with SR-aGVHD, 80% of whom had Grade C/D disease, and failed institutional standard of care

• Remestemcel-L was used as first-line therapy in Mesoblast’s open-label Phase 3 trial in 54 children with SRaGVHD, 89% of whom had Grade C/D disease

MAGIC1 N=302	Protocol 280 (pediatric) EAP 275 Study 001
	Placebo N=13 Remestemcel-L N=14 Remestemcel-L N=241 Remestemcel-L N=543
Day 28 Overall Response 43%	38% 64% 65% 69%
Day 100 Survival 57%	54% 79% 66% 74%

Source: ODAC Advisory Committee Briefing Document and Presentation August 2020.

1. Mount Sinai Acute GVHD International Consortium (MAGIC) - a group of ten BMT centers throughout the US and Europe whose purpose is to conduct ground-breaking clinical trials in GVHD, including developing informative biorepositories that assist in developing treatments that can guide GVHD therapy.

2. Two subjects in the MAGIC cohort had follow-up <100 days; these subjects are excluded from the respective survival analyses. 3. GVHD001 had 55 randomized patients, however one patient dropped out before receiving any dose of remestemcel-L

| 6

Cytokine Storm in COVID-19 ARDS Closely Resembles Secondary Hemophagocytic Lymphohistiocytosis (sHLH): A T Cell Driven Disease

• Secondary (or acquired) hemophagocytic lymphohistiocytosis (sHLH) is a life-threatening disease characterized by lymphocyte and macrophage hyperinflammation triggered by viral infections such as EBV, CMV, HHV)[1]

==> picture [85 x 88] intentionally omitted <==

• Lung involvement including ARDS is common and of poor prognosis (>50% mortality)[2]

• Hematological manifestations involve severe anemia due to activated macrophages engulfing red blood cells.

• Excessive immune activation driven by cytotoxic T cells and macrophages resulting in cytokine storm and release of IFN- 𝛾𝛾 , IL-6 and TNF- ⍺ , and reduction in regulatory T cells[3]

• Activated CD8 T cells producing IFN- 𝛾𝛾 appear to be central to disease pathogenesis

• Bode et al. Recent advances in the diagnosis and treatment of hemophagocytic lymphohistiocytosis. Arthritis Res Ther . 2012 Jun 8;14(3):213

• Seguin et al. Pulmonary Involvement in Patients With Hemophagocytic Lymphohistiocytosis. Chest . 2016 May;149(5):1294-301

• Humblet-Baron et at. IFN-γ and CD25 drive distinct pathological features during hemophagocytic lymphohistiocytosis. J Allergy Clin Immunol . 2019 Jun; 143(6): 2215–2226.e7

| 7

Robust Adaptive Naïve T Cell Response in COVID-19 is Critical for Viral Clearance Lack of Adequate T Cell Response Results in Increased Viral Load and Severe Disease

==> picture [85 x 88] intentionally omitted <==

Severe SARS2 infection

Average SARS2 infection

==> picture [433 x 214] intentionally omitted <==

==> picture [433 x 214] intentionally omitted <==

• Analysis of SARS-CoV-2-specific adaptive immune responses during acute COVID-19 identifies coordination between SARS-CoV-2-specific CD4 T cells and CD8 T cells to limit disease severity

• Aged individuals often exhibit uncoordinated adaptive responses, potentially tied to scarcity of naive T cells highlighting immunologic risk factors linked to disease severity

Rydyznski Moderbacher et al., Antigen-Specific Adaptive Immunity to SARS-CoV-2 in Acute COVID-19 and Associations with Age and Disease Severity. 2020, Cell 183, 996–1012; doi.org/10.1016/j.cell.2020.09.038 Sette A and Crotty S. Adaptive immunity to SARS-CoV-2 and COVID19.https://doi.org/10.1016/j.cell.2021.01.007

| 8

Severe COVID-19 Disease is Associated with Progressive Depletion of Naïve T Cells, and - Aberrant Activation of Non Naïve CD4 and CD8 T Cells

==> picture [584 x 139] intentionally omitted <==

==> picture [85 x 88] intentionally omitted <==

==> picture [100 x 13] intentionally omitted <==

----- Start of picture text -----

Naïve T Cells
----- End of picture text -----

==> picture [471 x 236] intentionally omitted <==

==> picture [456 x 255] intentionally omitted <==

----- Start of picture text -----

Non-Naïve Activated T Cells
HLA-DR+ HLA-DR+
KI67+ KI67+
CD38+ CD38+
80 100 ** * *


40
60 75
20
30
40 50
20 10
20 25
10
0 0 0
0
Frequencies of activated CD8 or CD4 T cells, shown as percent of non-naïve
CD8 and CD4 T cells expressing KI67 [+ ] and HLA-DR [+] CD38 [+ ]
% of Non-naïve CD8 T cells
% of Non-naïve CD4 T cells
----- End of picture text -----**

| 9

D. Mathew et al., Deep immune profiling of COVID-19 patients reveals distinct immunotypes with therapeutic implications Science 369, eabc8511 (2020). DOI:10.1126/science.abc8511

Severity of COVID-19 Infection is Associated with Increased Activated T Cells Producing IFN- 𝛾𝛾 and GM-CSF

==> picture [85 x 88] intentionally omitted <==

==> picture [570 x 353] intentionally omitted <==

Figure: Pathogenic Th1 cells with high expression of GM-CSF in COVID-19 patients.

(B) Representative density plots showing an analysis of co-expression of GM-CSF and IFN-γ in gated CD45+CD3+CD4+ T-cells isolated from peripheral blood in healthy controls, ICU and non-ICU patients of COVID-19.

(C) Statistics calculated by the percentage of GM-CSF+ or IL-6+ cells from CD4+ T-cells.

(D) Statistics calculated by the percentage of GM-CSF+ and IFN-γ + co-expressing CD4+ T- cells. Data represent the mean ± SEM. One-way ANOVA. P < 0.05 was considered statistically significant.

Zhou Y, et al. Pathogenic T cells and inflammatory monocytes incite inflammatory storm in severe COVID-19 patients. Natl Sci Rev. 2020;nwaa041

| 10| 10

Age > 65 years is Associated with Reduced Naïve T Cell Response to SARS-CoV-2, Delayed Viral Clearance and Greater Disease Severity

==> picture [931 x 470] intentionally omitted <==

----- Start of picture text -----

Delayed Viral Clearance and Greater Disease Severity
Naïve CD4
and CD8
T Cells
reduced in Age > 65 associated with greater
age > 65 COVID-19 peak disease severity
Median duration to
negative status
longer in subjects
over 65 years (43
days) compared
with under 65 years
(29 days)
----- End of picture text -----

Rydyznski Moderbacher et al., Antigen-Specific Adaptive Immunity to SARS-CoV-2 in Acute COVID-19 and Associations with Age and Disease Severity. 2020, Cell 183, 996–1012; doi.org/10.1016/j.cell.2020.09.038 Stehlik P et al. Repeat testing for SARS ‐ CoV ‐ 2: persistence of viral RNA is common, and clearance is slower in older people. Medical Journal of Australia 2021; doi:10.5694/mja2.51036

| 11

Meta-Analysis of Case Fatality Rates (CFR) for COVID-19 Patients on Invasive Mechanical Ventilation (IMV): Mortality Significantly Increases with Age

==> picture [85 x 88] intentionally omitted <==

				100%
										IMV			and		CFR Stratified byAge
	Alive	Dead	Unknown
Age	n (%, 95% CI)	n (%, 95% CI)	n (%, 95% CI)	90%
																						84.40%
≤40* (N=4,145)	1,575 (38.0, 36.5–39.5)	1,985 (47.9, 46.4–49.4)	585 (14.1, 13.1–15.2)	80%														77.10%
																71.30%
	1,872	2,870	542	70%
41–50* (N=5,284)	(35.4, 34.1–36.7)	(54.3, 53.0–55.7)	(10.2, 9.5–11.1)
				60%							59.30%
51–60* (N=9,060)	2,809 (31.0, 30.1–32.0)	5,373 (59.3, 58.3–60.3)	878 (9.7, 9.1–10.3)							54.30%
				50%	47.90%
	2,033	7,676	1,050
61–70* (N=10,759)	(18.9, 18.2–19.6)	(71.3, 70.5–72.2)	(9.6, 9.2–10.3)	40%	38%
									35.40%
	1,180	6,740	823								31%
71–80* (N=8,743)	(13.5, 12.8–14.2)	(77.1, 76.2–78.0)	(9.4, 8.8–10.0)	30%
>80* (N=4,627) 295 (6.4, 5.7–7.1) Reported case fatality rates for patients		3,903 (84.4, 83.3–85.4) 429 (9.3, 8.5–10.1) receiving invasive mechanical ventilation		10% 20%			14.10%			10.20%				18.90% 13.50% 9.70% 9.60%							6.40% 9.40%		9.30%
stratified by age, reported in six studies. *Age stratification for ICNARC was 16–39,
40–49, 50–59, 60–69, 70–79, and >80.		CFR = case fatality	rate; CI = confidence	0%	0–40* (N=4,145)				41–50* (N=5,284)		51–60 (N=9,060) 61–70 (N=10,759) 71–80* (N=8,743)											*>80 **	(N=4,627)
interval; Expon. = exponential; ICNARC = Intensive Care National Audit and Research Centre; IMV = invasive mechanical ventilation.							Alive Expon.(Alive)							Dead Expon.(Dead)						Unknown Expon.(Unknown)
							y = 0.6909e–0.351x							y = 0.429e0.1162x						y	=0.1297e–0.067x

Reported case fatality rates for patients receiving invasive mechanical ventilation stratified by age, reported in six studies. *Age stratification for ICNARC was 16–39, 40–49, 50–59, 60–69, 70–79, and >80. CFR = case fatality rate; CI = confidence interval; Expon. = exponential; ICNARC = Intensive Care National Audit and Research Centre; IMV = invasive mechanical ventilation.

Source: Am J Respir Crit Care Med Vol 203, Issue 1, pp 54–66, Jan 1, 2021. Sixty-nine studies were included, describing 57,420 adult patients with COVID-19 who received IMV. Fifty-four of 69 studies stated whether hospital outcomes were available but provided a definitive hospital outcome on only 13,120 (22.8%) of the total IMV patient population.

| 12

Objectives of Immunomodulation with Remestemcel-L in COVID ARDS

MSCs have the potential to:

==> picture [85 x 88] intentionally omitted <==

• -

• Reduce activated non naïve CD4 and CD8 T cells

• -

• Reduce inflammatory cytokines produced by non naive T cells to reduce macrophage and neutrophil influx, activation and cytokine storm

• Expand and enhance survival of naïve CD4 and CD8 T cells to accelerate viral clearance

• Improve pulmonary epithelial integrity

| 13

Clinical Experience with Remestemcel-L in COVID-19 ARDS

Emergency IND in Ventilator-Dependent COVID-19 ARDS

==> picture [85 x 88] intentionally omitted <==

• 11 patients (10/11 were < 65 years) with moderate or severe ARDS on ventilators, received two infusions of remestemcel-L 2 million cells/kg within five days at Mt. Sinai Hospital in New York City

• Nine patients (82%) successfully came off ventilator and were discharged from the ICU

• Experience under the emergency IND informed the dosing regimen for the randomized controlled Phase 2b/3 trial, however no data on this dosing regimen in patients ≥ 65 years

Phase 3 Randomized Controlled Trial in COVID-19 ARDS

• Multi-center, randomized, controlled, blinded study to assess safety and efficacy of remestemcel-L versus placebo in ventilator-dependent patients with moderate/severe ARDS due to COVID-19

• Up to 300 patients randomized 1:1 to receive placebo or two infusions of remestemcel-L within 3-5 days

• 222 patients enrolled before the study was stopped by DSMB as unlikely to meet primary endpoint of 43% overall mortality reduction

• The median age increased from 59 in the first half of the trial to 67 in the second half (p<0.0001)

• Preliminary results based on 60-day patient follow-up post randomization

• Pre-specified analysis of results stratified by age < or ≥ 65: 125 patients < 65 years, 97 patients ≥ 65 years

| 14

Baseline Summary Data: Intent	Baseline Summary Data: Intent	to Treat Patients Pre-Specified Age < 65 & ≥ 65	to Treat Patients Pre-Specified Age < 65 & ≥ 65	to Treat Patients Pre-Specified Age < 65 & ≥ 65	to Treat Patients Pre-Specified Age < 65 & ≥ 65	to Treat Patients Pre-Specified Age < 65 & ≥ 65
		ITT Patients < 65 years ITT Patients ≥ 65 years REM Mean n=58 Control Mean n=67 REM Mean n=54 Control Mean n=43 76% 24% 70% 30% 65% 35% 65% 35% 52 (9.9) 51 (9.8) 72 (5.7) 73 (5.5) 34.1 (7.7) 36.6 (8.2) 32 (7) 32(6) 29.8 (58.8) 19.5 (17.5) 17.2 (27.8) 26.4 (51.9) 163 (79) 17.%, 48%, 24% (11% missing or no ARDS) 144 (85) 9.%, 48%, 37% (6% missing or no ARDS) 132 (50) 13.%, 57%, 28% (2% missing or no ARDS) 150 (54) 14%, 67%, 14% (5% missing or no ARDS) 6.3 (2.4) 6.6 (1.8) 6.3 (2) 6.4 (1.9) 67% 50% 84% 67% 98% 78% 93% 67% 62% 63% 72% 74% 3% 4% 7% 5%
	Category		ITT Patients < 65 years		ITT Patients ≥ 65 years
			REM Mean n=58	Control Mean n=67	REM Mean n=54	Control Mean n=43
	Sex (%) Male Female		76% 24%	70% 30%	65% 35%	65% 35%
	Age (Yrs)		52 (9.9)	51 (9.8)	72 (5.7)	73 (5.5)
	BMI (kg/m2)		34.1 (7.7)	36.6 (8.2)	32 (7)	32(6)
	CRP (mg/L)		29.8 (58.8)	19.5 (17.5)	17.2 (27.8)	26.4 (51.9)
	PF Ratio ARDS Severity (mild, moderate, severe)		163 (79) 17.%, 48%, 24% (11% missing or no ARDS)	144 (85) 9.%, 48%, 37% (6% missing or no ARDS)	132 (50) 13.%, 57%, 28% (2% missing or no ARDS)	150 (54) 14%, 67%, 14% (5% missing or no ARDS)
	SOFA Score		6.3 (2.4)	6.6 (1.8)	6.3 (2)	6.4 (1.9)
	Any Steroids at Baseline Dexamethasone at Baseline		67% 50%	84% 67%	98% 78%	93% 67%
	Remdesivir at Baseline		62%	63%	72%	74%
	Anti-IL6 at Baseline		3%	4%	7%	5%

| 15

Baseline Summary Data: Increased Co-Morbid Conditions in Patients ≥ 65	Baseline Summary Data: Increased Co-Morbid Conditions in Patients ≥ 65	Baseline Summary Data: Increased Co-Morbid Conditions in Patients ≥ 65	Baseline Summary Data: Increased Co-Morbid Conditions in Patients ≥ 65	Baseline Summary Data: Increased Co-Morbid Conditions in Patients ≥ 65	Baseline Summary Data: Increased Co-Morbid Conditions in Patients ≥ 65	Baseline Summary Data: Increased Co-Morbid Conditions in Patients ≥ 65	Baseline Summary Data: Increased Co-Morbid Conditions in Patients ≥ 65
		ITT Patients < 65 years ITT Patients ≥ 65 years < 65 vs ≥ 65 REM Mean n=58 Control Mean n=67 REM Mean n=54 Control Mean n=43 Chi-Squared P-Value 2% 10% 0% 0% 0% 2% 3% 7% 3% 27% 7% 45% 50% 5% 1% 10% 0% 0% 0% 6% 4% 7% 3% 27% 0% 36% 49% 1% 13% 6% 4% 0% 2% 9% 19% 19% 4% 43% 0% 39% 67% 13% 12% 9% 0% 0% 2% 0% 19% 19% 2% 37% 12% 42% 70% 7% 0.0004 0.0002 0.0047 0.0464 0.0069 0.0074
	All Patients - ITT		ITT Patients < 65 years		ITT Patients ≥ 65 years		< 65 vs ≥ 65
			REM Mean n=58	Control Mean n=67	REM Mean n=54	Control Mean n=43	Chi-Squared P-Value
	Medical History COPD Asthma Pulmonary Fibrosis. CF MI last 12 months CHF Cancer Renal Disease Immunological Disorder Smoker Hepatic Diabetes Hypertension Neurological		2% 10% 0% 0% 0% 2% 3% 7% 3% 27% 7% 45% 50% 5%	1% 10% 0% 0% 0% 6% 4% 7% 3% 27% 0% 36% 49% 1%	13% 6% 4% 0% 2% 9% 19% 19% 4% 43% 0% 39% 67% 13%	12% 9% 0% 0% 2% 0% 19% 19% 2% 37% 12% 42% 70% 7%	0.0004 0.0002 0.0047 0.0464 0.0069 0.0074

| 16

Greater Mortality through Day 60 in Control Patients Older than 65,Older than 65,, Consistent with Other Trials

==> picture [931 x 470] intentionally omitted <==

----- Start of picture text -----

Greater Mortality through Day 60 in Control Patients Older than 65,Older than 65,,
Consistent with Other Trials
Controls Age < 65 vs ≥ 65 (n=110)
Mortality Through 60 Days
42% (28/67) <65 vs 70% (30/43) ≥65
HR: 2.098; 95% CI (1.251, 3.519), p=0.005
Log Rank p-value = 0.0042
Days from Day 0 Treatment
Absence of All Cause Death at Day 60
----- End of picture text -----

| 17

Remestemcel-L vs Controls with COVID-19 ARDS: Mortality through 60 Days in Treated Patients

==> picture [931 x 470] intentionally omitted <==

----- Start of picture text -----

Mortality through 60 Days in Treated Patients
All Modified Intent to Treat Patients (n=217), Remestemcel-L vs Control
Mortality Through 60 Days
REM 48.2% (53/110) vs Control 53.3% (57/107)
HR: 0.857; 95% CI (0.589, 1.246), p=0.418
Log Rank p-value = 0.423
Days from Day 0 Treatment
Absence of All Cause Death at Day 60
----- End of picture text -----

| 18

Remestemcel-L vs Controls:

==> picture [931 x 470] intentionally omitted <==

----- Start of picture text -----

Pre-Specified Mortality Analysis through 60 Days < or ≥ 65 Years Old
Modified Intent to Treat Patients < 65 years old (n=123) Modified Intent to Treat Patients ≥ 65 years old (n=94)
REM vs Control REM vs Control
Mortality Through 60 Days Mortality Through 60 Days
REM 26% (15/57) vs Control 42% (28/66) REM 72% (38/53) vs Control 71% (29/41)
HR: 0.536; 95% CI (0.286, 1.005), p=0.05 HR: 1.053; 95% CI (0.649, 1.708), p=0.8332
Log Rank p-value = 0.0483 Log Rank p-value = 0.8206
Days from Day 0 Treatment
Days from Day 0 Treatment
Absence of All Cause Death at Day 60 Absence of All Cause Death at Day 60
----- End of picture text -----

| 19

Remestemcel-L vs Controls: Analysis of Respiratory Function Improvement*

==> picture [879 x 374] intentionally omitted <==

----- Start of picture text -----

Treated Patients (mITT) < 65 years old (n=123) Treated Patients (mITT) ≥ 65 years old (n=94)
Remestemcel-L vs Control Remestemcel-L vs Control
Respiratory Function Improvement: Patients < 65 years Respiratory Function Improvement: Patients ≥ 65 years
80% 80%
70% 70%
60% 60%
50% 50%
40% 40%
30% 30%
20% 20%
10% 10%
0% 0%
Day 7 Day14 Day 21 Day 30 Day 7 Day14 Day 21 Day 30
OR: 1.2 OR: 2.1 OR: 1.9 OR: 2.2 OR: 2.1 OR: 1.1 OR: 0.94 OR: 0.75
95% CI: 0.57, 2.4 95% CI: 1.0, 4.5 95% CI: 0.90, 4.1 95% CI: 1.0, 4.7 95% CI: 0.83, 5.1 95% CI: 0.43, 2.7 95% CI: 0.38, 2.4 95% CI: 0.30, 1.9
Rem-L Placebo Rem-L Placebo
% of Subjects Improved from Baseline % of Subjects Improved from Baseline
----- End of picture text -----

• Measured as resolution and/or improvement of ARDS as defined by the Berlin criteria at Days 7, 14, 21, and 30 post-randomizations

| 20

Dynamic Changes in the Treatment Regimes During the Trial

| 21

Source: Noel A. et al. Epic Health Research Network. Nov 2020

Dexamethasone did not Reduce Mortality in Controls on Invasive Mechanical Ventilation with Moderate/Severe COVID-19 ARDS

==> picture [931 x 470] intentionally omitted <==

----- Start of picture text -----

Dexamethasone did not Reduce Mortality in Controls on Invasive Mechanical Ventilation
with Moderate/Severe COVID-19 ARDS
Controls < 65 years old +/- Dexamethasone (ITT n=67) Controls ≥ 65 years old +/- Dexamethasone (ITT n=43)
Mortality Through 60 Days
Mortality Through 60 Days
Dex 44% (20/45) vs No Dex 36% (8/22)
Dex 72% (21/29) vs No Dex 64% (9/14)
Log Rank p-value = 0.5541
Log Rank p-value = 0.815
Days from Day 0 Treatment Days from Day 0 Treatment
Absence of All Cause Death at Day 60
Absence of All Cause Death at Day 60
----- End of picture text -----

| 22

Remestemcel-L plus Dexamethasone: Synergistic in Reducing Mortality in Exploratory Population < 65 years old

==> picture [931 x 470] intentionally omitted <==

----- Start of picture text -----

Synergistic in Reducing Mortality in Exploratory Population < 65 years old
All Treated Patients < 65 years old
on Dexamethasone (n=73)
Mortality Through 60 Days
REM + Dex 14% (4/29) vs Dex 45% (20/44)
HR: 0.248; 95% CI (0.085, 0.727), p=0.011
Log Rank p-value = 0.006
Days from Day 0 Treatment
Absence of All Cause Death at Day 60
----- End of picture text -----

| 23

Remestemcel-L Increases Ventilator-Free Days Alive through 60 Days in Patients < 65 years old

All Treated Patients < 65 years old on Dexamethasone (n=73)

All Treated Patients < 65 years old (n=123)

==> picture [85 x 88] intentionally omitted <==

==> picture [420 x 324] intentionally omitted <==

==> picture [421 x 324] intentionally omitted <==

Ventilator-Free Days Alive Through Day 60

Ventilator-Free Days Alive Through Day 60

| 24

Remestemcel-L plus Dexamethasone: Analysis of Respiratory Function and Clinical Improvement* in Exploratory Population < 65 years old

Treated Patients (mITT) < 65 years old on Dexamethasone (n=73)

Treated Patients (mITT) < 65 years old on Dexamethasone (n=73)

==> picture [85 x 88] intentionally omitted <==

==> picture [881 x 330] intentionally omitted <==

----- Start of picture text -----

Respiratory Function Improvement: Patients < 65 Years on
Clinical Improvement: Patients < 65 Years on Dexamethasone
Dexamethasone
90% 70%
80%
60%
70%
50%
60%
40%
50%
40% 30%
30%
20%
20%
10%
10%
0% 0%
Day 7 Day14 Day 21 Day 30 Day 7 Day14 Day 21 Day 30
OR: 1.1 OR: 2.6 OR: 2.0 OR: 3.6 OR: 9.0 OR: 1.7 OR: 2.1 OR: 2.9
95% CI: 0.41, 2.8 95% CI: 0.94, 7.2 95% CI: 0.72, 5.4 95% CI: 1.2, 10.7 95% CI: 0.95, 84.8 95% CI: 0.62, 4.6 95% CI: 0.78, 5.5 95% CI: 1.1, 7.7
Rem-L Placebo Rem-L Placebo
% of Subjects Improved from Baseline % of Subjects Improved from Baseline
----- End of picture text -----

• Respiratory Function Improvement measured as resolution and/or improvement of ARDS as defined by the Berlin criteria at Days 7, 14, 21, and 30 post-randomizations; Clinical Improvement was assessed based on a 7-point ordinal scale at baseline and on Days 7, 14, 21, and 30 and discharge from hospital

| 25

Conclusions and Next Steps for Remestemcel-L in ARDS Due to COVID-19

• Remestemcel-L did not significantly reduce overall mortality

==> picture [85 x 88] intentionally omitted <==

• Remestemcel-L reduced mortality and increased ventilator-free days through 60 Days in pre-specified patient population < 65 years old

• Addition of remestemcel-L to dexamethasone was synergistic in reducing mortality and increasing days alive off ventilator through 60 Days in exploratory analysis of patients < 65

• Plan to meet with U.S. Food and Drug Administration (FDA) to discuss potential next steps

• Confirmatory Phase 3 trial in COVID-19 ARDS patients < 65 years of age with dexamethasone, explore additional remestemcel-L dosing regimens for patients with ARDS ≥ 65 years of age

| 26

==> picture [62 x 65] intentionally omitted <==

meso blast the regenerative medicine company