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INVESTOR PRESENTATION
JUNE 2019
2
Forward-looking statements
This presentation contains forward-looking statements about BeyondSpring Inc. (“BeyondSpring” or the “Company”). Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to ourmanagement, including those described in the forward-looking statements and risk factors sections of the Company’s 20-F andother filings with the United States Securities and Exchange Commission (SEC), which are available on BeyondSpring’s InvestorRelations website.
Such statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’sactual results, levels of activity, performance, or achievements to be materially different from those anticipated by suchstatements. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,”“expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “intends,” or “continue,” or the negative ofthese terms or other comparable terminology. Forward-looking statements contained in this presentation include, but are notlimited to, (i) statements regarding the timing of anticipated clinical trials for our product candidates and our research anddevelopment programs; (ii) the timing of receipt of clinical data for our product candidates; (iii) our expectations regarding thepotential safety, efficacy, or clinical utility of our product candidates; (iv) the size of patient populations targeted by our productcandidates and market adoption of our product candidates by physicians and patients; and (v) the timing or likelihood ofregulatory filings and approvals.
Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update thereasons why actual results could differ materially from those anticipated in the forward-looking statements, even if newinformation becomes available in the future.
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Agenda
Plinabulin
NSCLC
CIN: Study 105 (Phase 2) – Intermediate Risk Chemotherapy
Commercial Opportunities
Company Overview
CIN: Study 106 (Phase 2) – High Risk Chemotherapy
4
BeyondSpring is well positioned to capture the significant market potential with severe unmet medical needs
Plinabulin – a First-in-Class asset
Late stage global registrational trials targeting unmet medical needs
Pipeline in a drug Patent protection in major markets
Strong pipeline and platform
Early-stage pipeline for IO combos potentially enhances efficacy and safety profile
Pioneer in ubiquitination pathway platform
Visible near term milestones
NSCLC: China and U.S. NDA submissions expected in 2019 and 2020, respectively
CIN: China and U.S. NDA submissions expected in 2019 and in 2020, respectively
1Differentiated MoA
Unique mechanism leading to both CIN and anti-cancer effect
Differentiated from other T.B. Data presented at major conferences
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World-class execution
One global multi-center trial to support parallel filings in U.S. and China
CROs & CMOs meeting U.S. GCP/GMP standards
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Strong validation by KOLs and FDA
Trials led by world renowned KOLs as principal investigators
Potential inclusion in NCCN guideline Record trial initiation speed
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Superior trial data support
Superiority in efficacy and safety with statistical significance
Consistent trend in multiple trials Comprehensive safety database
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Visionary senior management
Deep industry knowledge and experience
Together brought 30+ drugs to the global market
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Robust drug development pipeline
Note: 1 We own global rights to Plinabulin in all countries except China. In China, we own a 60% interest in our Chinese subsidiary, Wanchun Bulin, which owns a 100% interest in Plinabulin.
Program Indication Trial name Preclinical Phase 1 Phase 2 Phase 3 Commercial rights
China NDA filing
U.S. NDA filing
Late
stag
e
Plinabulin + docetaxel NSCLC
(2nd/3rd line)Study 103 Global1 2019 2020
Plinabulin
CIN
Study 105
Global1 2019 2020
Plinabulin + pegfilgrastim Study 106
Inve
stig
ator
-initi
ated
IO Plinabulin + nivolumabNSCLC
(2nd/3rd line)
Fred Hutch/Univ.
Washington/UCSDGlobal1
Plinabulin + nivolumab + ipilimumab SCLC Rutgers University Global1
Plinabulin + pembrolizumab + chemo
NSCLC (1st line) Johns Hopkins Global1
Oth
er o
ncol
ogy
pipe
line
Ubiquitination platform Target KRAS Univ. Washington /NYU Global
BPI-002 Oral CTLA-4 inhibitor Global
BPI-003 IKK inhibitor Global
BPI-004 Neo-antigen generator Global
Phase 3 first interim data analysis completed
Phase 3 primary end point met at interim analysis
Phase 2 efficacy / safety end points met
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Visionary management team
Gordon Schooley,Ph.D.
Kenneth Lloyd, Ph.D.
Ramon Mohanlal, M.D., Ph.D.
Lan Huang, Ph.D.
James Tonra, Ph.D.
Co-founder, Chairman & Chief Executive Officer
Co-founded CRO Paramax and sold to RPS, co-founded Wuxi MTLH and sold self-designed peptide drug to Shanghai Pharmaceutical
Board member of Oncology Drug Review Board of China Pharma Assoc
Trained at UC Berkeley and MSKCC
Chief Medical Officer & EVP, Research and Development
More than 20 years experience in strategic drug development, including executive positions at GSK and Vertex
Previously Head of Established Products Oncology for Novartis
Chief Scientific Officer
Greater than 45 years experience in pharmaceutical industry drug discovery and development
Previously held executive and scientific positions at Roche, Synthelabo, Wyeth-Ayerst, SIBIA, and Nereus
Chief Regulatory Officer
Executive for more than 20 years leading clinical and regulatory affairs
Previously held executive and regulatory positions at SkyePharma, Alliance Pharmaceutical and Pacira Pharma
SVP, Preclinical Development
20+ years of experience in biotechnology research
Leading research efforts at Regeneron, Millennium and ImClone
Authored 40+ peer-reviewed publications and led 8 IND filings and clinical strategy development
Edward Liu
Chief Financial Officer
Over a decade of experience in global capital markets, equity financing, M&A, and healthcare investment
Previously senior banker at J.P. Morgan and Jefferies
Former Partner and Executive Director at a cross-border healthcare focused fund
Richard Daly
Chief Operating Officer
25+ years of experience heading BD and commercial operations for leading pharmaceutical companies
Former Executive Vice President at Takeda U.S. and President of AstraZeneca’s U.S. Diabetes subsidiary
10 product launches and 8 strategic alliances
Lihua Du
China General Manager
30 years of experience in drug development, clinical and regulatory affairs in China
Participated in approvals of 12 marketed drugs in China
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World renowned scientific advisors and principal investigators
Douglas Blayney, M.D.
Jeffrey Crawford, M.D.
Yuankai Shi, M.D.
Yan Sun, M.D. Avram Hershko, M.D.
Principal Investigator, Study 105 & Study 106
Founding member and former Board Member of the NCCN Guidelines for Neutropenia Management in U.S.
Former president of ASCO
Former member of the FDA’s Oncologic Drugs Advisory Committee
Medical Director of Stanford Cancer Institute
DSMB Chairman, Study 105 & Study 106
Chairman of NCCN Guidelines for Neutropenia Management in U.S.
Lead investigator of the U.S. multicenter, randomized trial of Filgrastim (G-CSF, Neupogen), leading to FDA approval
Professor of Medicine at Duke University
Principal Investigator, Study 105 & 106 China
Chairman of the NCCN Guidelines for Neutropenia Management in China
Director of Oncology Department at Cancer Hospital Chinese Academy of Medical Sciences
SAB Member, Study 103
Chairman of NCCN Guideline for NSCLC and Board of Directors of NCCN Guideline
Alex Grass Professor of Oncology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University
Principal Investigator, Study 103 China
Chairman of the NCCN Guidelines for NSCLC in China
Co-founder of the Steering Committee of the Chinese Society of Clinical Oncology (CSCO)
Director of GCP Center at Cancer Hospital of Chinese Academy of Medical Sciences
SAB Member, Ubiquitination Platform
Nearly 50 years of research leadership in ubiquitination pathway
2004 Nobel Prize in Chemistry for discovery of ubiquitin-mediated protein degradation
Distinguished Professor at Rappaport Faculty of Medicine at Technion in Haifa
David Ettinger, M.D.
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Agenda
Plinabulin Overview
NSCLC
CIN: Study 105 (Phase 2) – Intermediate Risk Chemotherapy
Commercial Opportunities
Company Overview
CIN: Study 106 (Phase 2) – High Risk Chemotherapy
9
Plinabulin profile
Small molecule
Inexpensive to manufacture
Given by IV infusion
Used in 500+ cancer patients to-date with good tolerability
Currently in Phase 3 in two indications
Potential for multiple cancer indications
76 patents granted globally, 20 patents issued in U.S. Issued and allowed U.S. patents directed to composition of matter, polymorph
synthesis and use are scheduled to expire between 2021 and 2036 (excluding any potential patent term restoration)
Pending: target, new use
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Plinabulin: first-in-class agent with GEF-H1 as new target
Note: 1 Chang et al., 2008 Mol Biol Cell; Kashyap et al., 2018 submitted. 2 Zhang et al., 2005 Mol Cell Biol. 3 Keystone Meeting, Mar 2017; Kashyap et al. 2018 submitted. 4 Singh et al., 2011 Blood. 5 Keystone Meeting, Mar 2017; Unpublished findings: University of Basel. 6 Keystone Meeting, Mar 2017. 7 Suwa et al., 2000 Am J Physiol Heart Circ Physiol; Ghosh et al., 2018 ACR Annual Conference; Blayney et al., Society of Leukocyte Biology. 8 Asensi et al., 2004 Infection and Immunity.
Dendritic cell maturation3
GEF-H1 activation1
Rho/ROCK activation1
T cell activation3
Kill cancercells5
Kill cancer cells4
IL-6 activation6
Accelerate neutrophil maturation7
Neutrophil demargination7
JNK activation2
Microtubules
Delay neutrophil apoptosis8
Plinabulin
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Agenda
Plinabulin Overview
NSCLC
CIN: Study 105 (Phase 2) – Intermediate Risk Chemotherapy
Commercial Opportunities
Company Overview
CIN: Study 106 (Phase 2) – High Risk Chemotherapy
12
NSCLC: potential large market opportunity for Plinabulin
Plinabulin + docetaxel
EGFR wild typemOS = 6-8 months
70% of Asian patients85% of Western patients
2nd / 3rd line NSCLC
PD-1/PD-L120% of patients
EGFR mutant mOS = 18.3 months
30% of Asian patients15% of Western patients
Current approved therapies
Approved therapies do not address the vast majority of NSCLC genotypes; creating a significant opportunity:
Effectiveness only in specific tumor mutations
Limited patient response in many patients
Unique safety risks across therapeutic modalities
Plinabulin targeted patients
Plinabulin being explored in the 2nd line and 3rd line:
EGFR wild type patients account for 70%-85% of patient population
Patients with measurable lung lesions based on RECIST 1.1 criteria, with tumor over 1cm at CT scan (around 70% of NSCLC patients, according to Phase 2 data)
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Approved therapies fail to address EGFR wild type NSCLC (80-90% of western patients) in 2nd and 3rd lines
Only four treatments are currently approved: docetaxel, pemetrexed, ramucirumab and PD-1
Nivolumab (PD-1) vs.
docetaxel1
Pemetrexedvs.
docetaxel2
Ramucirumab + docetaxel
vs.docetaxel3
Plinabulin +docetaxel
vs.docetaxel
mOS+2.8 months
(12.2 vs. 9.4)+0.4 months(8.3 vs. 7.9)
+1.4 months(10.5 vs. 9.1)
+4.6 months(11.3 vs. 6.7)
ORR 19% vs.12% 9.1% vs. 8.8% 23% vs. 14% 18.4% vs.10.5%
Grade 3/4 neutropenia 0% vs. 27% 5% vs. 40% 49% vs. 39% 7% vs. 26%
DOR 17 vs. 6 months 4.6 vs. 5.3 months 12.7 vs. 1 months
80% patients refractory to PD-1/PD-L1
Approved based on low grade 3/4 neutropenia
Approved based on 1.4 months OS benefit
Study 101: Phase 2 data
Note: 1 NEJM 373: 1627-1639 (2015). 2 JCO 22(9): 1589-1597 (2004). 3 Lancet 384 (9944): 665-673 (2014).
Moving into 1st line 2nd & 3rd lines
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Study 101 (phase 2): Plinabulin safety summary
As of now, Plinabulin generally well tolerated (> 500 patients); no cardio adverse effects with two-year follow-up
AEs are dose-dependent and manageable
Grade 3/4 Adverse Event (AE) as % in patients
Plinabulin 20mg/m2 (2 doses) + docetaxel 75mg/m2
(n=40)
Plinabulin 30mg/m2 (2 doses) + docetaxel 75mg/m2
(n=50)Docetaxel 75mg/m2
(n=73)
Nausea (N) 0 4 0Vomiting (V) 0 4 1Diarrhea (D) 5 8 6Constipation 0 0 1Anorexia 3 0 0Fatigue 3 4 10Asthenia 13 2 4Arthralgia 0 0 0Myalgia 0 2 0Headache 3 0 0Dizziness 0 0 0Dyspnea 5 4 14Cough 0 0 0Alopecia 0 0 0Hypokalemia 5 0 1Anemia 5 8 2Leukopenia 0 2 9Neutropenia 5 8 26Pyrexia 0 0 2Tachycardia 0 0 0Transient Hypertension (TH) 5 20 0
Increased AE Reduced AE
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Study 103: phase 3 in NSCLC – first interim data analysis completed; DSMB recommended trial to continue
# of patients & sites Approximately 550 patients in 60 sites in U.S., Australia and China
Patient enrollment Patients with at least 1 measurable lung lesion; 2nd-/3rd-line NSCLC
PD-1/PD-L1 antibody failures (stratified)
EGFR wild type, mutations not eligible; no restriction on histology
One prior platinum-based chemotherapy; no restriction on biological therapy
SAP Plan: KRAS mutant subgroup; PD-L1 expression subgroup; tumor size subgroup; prior treatment include PD-1/PD-L1 or not
Primary objective Overall survival
Secondary objective Grade 4 neutropenia (C1D8), DOR, QoL questionnaires, ORR, PFS
Dosing cohorts Arm 1 – docetaxel (75 mg/m2)
Arm 2 – docetaxel (75 mg/m2) + Plinabulin (30 mg/m2)
Pre-specified interim analysis First look: at 1/3 patients mortality, sample size will re-adjust if hazard ratio (HR) > 0.75 based on mOS
Second look: at 2/3 patients mortality, study will stop if p <= 0.012 for mOS
Status First interim data analysis completed; second interim data readout in 2H 2019
Phase 3 study (randomized single blinded)
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Agenda
Plinabulin Overview
NSCLC
CIN: Study 105 (Phase 2) – Intermediate Risk Chemotherapy
Commercial Opportunities
Company Overview
CIN: Study 106 (Phase 2) – High Risk Chemotherapy
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Study 105: phase 2/3 in neutropenia (intermediate risk chemo)Primary objective met at interim analysis
# of patients & sites 55 patients in 43 sites
Patient enrollment Patients with 2nd/3rd line NSCLC
Primary objective To establish the Recommended Phase 3 Dose (RP3D) based on PK/PD analysis
Dosing cohorts Arm 1 – Docetaxel (75 mg/m2) + Neulasta® (pegfilgrastim) (6 mg) (n=14)
Arm 2 – Docetaxel (75 mg/m2) + Plinabulin (5 mg/m2) (n=14)
Arm 3 – Docetaxel (75 mg/m2) + Plinabulin (10 mg/m2) (n=14)
Arm 4 – Docetaxel (75 mg/m2) + Plinabulin (20 mg/m2) (n=13)
Status Completed
Phase 2 study (randomized open label)
# of patients & sites Approximately 105 patients in 55 sites
Patient enrollment Patients with 2nd line breast cancer, 1st line prostate cancer or 2nd/3rd line NSCLC
Primary objective DSN in cycle 1, non-inferiority margin of 0.65 days
Secondary objectives Incidence of grade 4 neutropenia, febrile neutropenia, infection, antibiotic use, docetaxel dose change
Incidence and duration of hospitalization due to febrile neutropenia
Incidence and severity of bone pain
Dosing cohorts Arm 1 – Docetaxel (75 mg/m2) + Neulasta® (pegfilgrastim) (6 mg) (n=75)
Arm 2 – Docetaxel (75 mg/m2) + Plinabulin (RP3D) (n=75)
Status Primary objective met at interim analysis
Phase 3 study (randomized double blinded)
One dose Plinabulin per cycle, 30 minutes after chemotherapy on day 1, 30 minutes IV infusion
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Study 105 (phase 2): Plinabulin 20mg/m2 had similar incidence of neutropenia as Neulasta
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
1 2 3 4
% o
f pat
ient
s
Grade
Neulasta 6mg (n=14) Plinabulin 20mg/m2 (n=14)
Plinabulin 10mg/m2 (n=13) Plinabulin 5mg/m2 (n=14)
% of incidence of neutropenia in cycle 1 after Docetaxel for NSCLC
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Study 105 (phase 2): Plinabulin 20mg/m2 showed superior safety profile compared to Neulasta
% incidence in thrombocytopenia in cycle 1
0%5%
10%15%20%25%30%
Grade 1 Grade 2 Grade 3 Grade 4Neulasta 6mg (n=14) Plinabulin 20mg/m2 (n=14)
0%
5%
10%
15%
20%
25%
30%
35%
40%
1 2 3 4 5 6 7 8 9
% o
f pat
ient
s
Day
Neulasta 6mg (n=14)Plinabulin 20mg/m2 (n=14)
% of bone pain in cycle 1 after Docetaxel for NSCLCNeutrophil to lymphocyte ratio (NLR) in cycle 1
NLR>5 -> immune suppressive
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Study 105 (phase 2): Plinabulin demonstrated a clear superiority profile against Neulasta, standard of care
Neulasta Plinabulin 20mg/m2
DSN (grade 4) 0.5 day 0.5 day
% neutropenia (grade 4) 14% 14%
% bone pain Yes No from day 3
Thrombocytopenia Yes No
Immune suppression Yes No
Anti-cancer No Yes
Plinabulin demonstrates a clear superiority profile in cycle 1 after Docetaxel for NSCLC
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Agenda
Plinabulin Overview
NSCLC
CIN: Study 105 (Phase 2) – Intermediate Risk Chemotherapy
Commercial Opportunities
Company Overview
CIN: Study 106 (Phase 2) – High Risk Chemotherapy
22
Severe unmet medical needs – vast majority of patients in high risk chemo “escape” standard of care today
Note: 1 Masuda N et al., Support Care Cancer 23: 2891-2898 (2015). 2 Lee J et al., Annals of Surgical Treatment and Research 94(5): 223-238 (2018). 3 Kirshner et al., Comm Onc 4:455-459 (2007). 4 Xu et al., Support Care Cancer 24:723-730 (2016). 5 Lalami et al., Critical Reviews in Oncology / Hematology 120 163-179 (2017). 6 O’Regan et al., Clinical Breast Cancer 6(2): 163-168 (2005). 7 Vasey et al., British J Cancer 87: 1072-78 (2002). 8 Alba et al. JCO 22(13): 2587-93 (2002). 9 Moore et al, Annals of Pharmacotherapy 51(9): 797-803 (2017).
Efficacy Neulasta 6.0 mg1
n=29Neulasta 6.0 mg2
n=61
Neutropenia (grade 3/4) 96.6% 100%
DSN 1.4 ± 0.7 1.8 ± 1.2
Mean ANC nadir (109/L) 0.255 ± 0.287 0.266
Neulasta after TAC for breast cancer
Limited choices to manage bone pain: NSAIDs (causing blood clots), antihistamine (mixed results), opioids (not allowed), Neulasta dose reduction (higher risk of FN)9
Safety Neulasta 6.0 mg3
n=100Neulasta 6.0 mg4
Bone pain (score of 1-10) 59% 71%
Severe bone pain (score of 6-10) 24% 27%
Neulasta after chemotherapy
Guidelines for grade 3/4 neutropenia is to reduce or delay chemotherapy dosing by 5-7 days5
In cancer patients with <85% relative dose intensity (RDI), patient survival is 50% of those with >=85% RDI5
TAC is a very effective chemo treatment with ORR at 84%6, but because of its high severe neutropenia rate, TAC needs to be changed to less effective TC (with ORR at 42%)7 and TA (with ORR at 51%)8
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Study 106: phase 2/3 in neutropenia (high risk chemo)Efficacy and safety objections met at top line analysis
# of patients & sites Approximately 115 patients in 41 sites
Patient enrollment Patients with 1st line breast cancer
Primary objective To establish the Recommended Phase 3 Dose (RP3D) based on PK/PD analysis
Dosing cohorts Arm 1 – TAC + Neulasta® (pegfilgrastim) (6 mg)
Arm 2 – TAC + Plinabulin (10 mg/m2)
Arm 3 – TAC + Plinabulin (20 mg/m2)
Arm 4 – TAC + Plinabulin (30 mg/m2)
Arm 5 – TAC + Plinabulin (20 mg/m2) + Neulasta® (pegfilgrastim) (1.5 mg)
Arm 6 – TAC + Plinabulin (20 mg/m2) + Neulasta® (pegfilgrastim) (3 mg)
Arm 7 – TAC + Plinabulin (20 mg/m2) + Neulasta® (pegfilgrastim) (6 mg) (the “Plinabulin / Neulasta Combo”)
Status Efficacy and safety objectives met at top line analysis
Phase 2 study (randomized open label)
# of patients & sites Approximately 300 patients in 41 sites
Patient enrollment Patients with 1st line breast cancer
Primary objective Non-inferiority first; if met, superiority in cycle 1 DSN
Dosing cohorts Arm 1 – TAC + Neulasta® (pegfilgrastim) (6 mg)
Arm 2 – TAC + Plinabulin/Neulasta® RP3D
Status To be initiated, final data readout in 2H 2019
Phase 3 study (randomized double blinded)
One dose Plinabulin per cycle, 30 minutes after chemotherapy on day 1, 30 minutes IV infusion
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Study 106 (phase 2): Plinabulin and Neulasta has complimentary absolute neutrophil count (ANC) profile
Median ANC in cycle 1 after TAC for breast cancer
0.0
1.0
2.0
3.0
4.0
5.0
6.0
7.0
6 7 8 9 10
Med
ian
ANC
(109
cells
/L)
Day in cycle 1
Neulasta 6mg (n=21) Plinabulin 30mg/m2 (n=12)
Plinabulin 20mg/m2 (n=15) Plinabulin 10mg/m2 (n=15)
Grade 3 Neutropenia (> 0.5 & < 1.0)
Grade 4 Neutropenia (< 0.5)
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Study 106 (phase 2): Plinabulin / Neulasta Combo enhanced absolute neutrophil count (ANC) profile
Median ANC in cycle 1 after TAC for breast cancer
0.0
1.0
2.0
3.0
4.0
5.0
6.0
7.0
6 7 8 9 10
Med
ian
ANC
(109
cells
/L)
Day in cycle 1
Neulasta 6mg (n=21) Plinabulin 20mg/m2 + Neulasta 6mg (n=16)
Plinabulin 20mg/m2 + Neulasta 3mg (n=21) Plinabulin 20mg/m2 + Neulasta 1.5mg (n=14)
Grade 3 Neutropenia (> 0.5 & < 1.0)
Grade 4 Neutropenia (< 0.5)
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Study 106 (phase 2): Plinabulin / Neulasta Combo demonstrated positive efficacy data in prevention of CIN
81%
50%
Neulasta6mg
(n=21)
Plinabulin 20mg/m2 +Neulasta 6mg
(n=16)
% incidence of grade 3/4 neutropenia in cycle 1 after TAC for breast cancer
p = 0.0456
Duration of grade 3/4 neutropenia in cycle 1 after TAC for breast cancer (days)
1.38
0.94
Neulasta6mg
(n=21)
Plinabulin 20mg/m2 +Neulasta 6mg
(n=16)
Reduction of 36%
27
Study 106 (phase 2): Plinabulin / Neulasta Combo demonstrated positive safety data in prevention of CIN
At lease X days of bone pain in cycle 1 after TAC for breast cancer
95%
38%
6%0%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
1 2 3 4 5 6 7 8
% o
f pat
ient
s
At least X days of bone pain
Neulasta 6mg (n=21) Plinabulin 20mg/m2 + Neulasta 6mg (n=16)
p < 0.0001
p = 0.0056
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Study 106 (phase 2): Plinabulin / Neulasta Combo demonstrates a clear superiority profile against Neulasta, standard of care
Neulasta Plinabulin / Neulasta Combo
DSN (grade 3/4) Over 1 day Less than 1 day
% neutropenia (grade 3/4) High (> 80%) Low (50%)
Median ANC nadir (109 cells/L) 0.47 (> 50% with grade 4 neutropenia)1.00 (> 50% avoid grade 3/4
neutropenia)
% bone pain Almost all Limited
Immune suppression Yes Limited
Anti-cancer No Yes
Plinabulin / Neulasta Combo demonstrates a clear superiority profile after TAC for breast cancer
29
Agenda
Plinabulin Overview
NSCLC
CIN: Study 105 (Phase 2) – Intermediate Risk Chemotherapy
Commercial Opportunities
Company Overview
CIN: Study 106 (Phase 2) – High Risk Chemotherapy
30
Rising global incidence of non-small cell lung cancer
2015 NSCLC market size by region1, 3
55.9%
22.0%
23.6%
U.S. Europe Japan + China
Global NSCLC market size and growth ($ billion)2
$0$5
$10$15$20$25$30$35$40
17 18 19 20 21 22 23 24 25 26US Japan France Germany Italy Spain UK
~1.8 million lung cancer diagnoses globally, 87% NSCLC
Sales of key NSCLC drugs across the U.S., Japan, and five major EU markets totaled $11.5bn in 2017 and expected to increase to $33.9bn by 2026
Increasing incidence of NSCLC and use of premium-priced checkpoint inhibitor therapies, particularly in the 1st line setting, are the major drivers of growth
Nearly 1/3 of global patients are in China: $445mm sales in 2015; projected to be $4.3bn in 20253
Source: GlobalData; 2DatamonitorNote: 1 Market share by regions broken out into the 8 major markets for NSCLC: France, Germany, Italy, Japan, Spain, UK and U.S. 3 China NSCLC market forecast.
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Global neutropenia market
CIN market = $7 billion in 2017 (mainly used with high risk chemo)
China and the U.S. represent 2/3 of all G-CSF global therapy
Plinabulin positioning: Plinabulin as mono or combo therapy improves on the standard of care in the treatment of Chemotherapy Induced Neutropenia; potential for improved chemotherapy outcome
Addressable market
Combination with G-CSF to
Improved neutropenia
Reduced bone pain
Improve compliance & persistency with chemo
Global
G-CSF cycles/year = 4.3 million1
G-CSF market value = $7 billion
Plinabulin + G-CSF: reduced neutropenia and improved bone pain; potential for improved compliance and persistency with chemo
Plinabulin: reduced bone pain; improved thrombocytopenia and immune function
Canada$140M/yr G-CSF market
80K G-CSF cycles/yr
EU 5$870M/yr G-CSF market
850K G-CSF cycles/yr
South Korea$46M/yr G-CSF market
18% peg growth YoY78K G-CSF cycles/yr
United States$5+B/yr G-CSF market1.3M G-CSF cycles/yr
China$350M/yr G-CSF market
20% cycle growth YoY33% $ G-CSF growth YoY
1.6M G-CSF cycles/yr
Australia$40M/yr G-CSF market
53K G-CSF cycles/yr
Japan$240M/yr G-CSF market
7% peg growth YoY330K G-CSF cycles/yr
Note: 1 https://onlinelibrary.wiley.com/doi/full/10.3322/caac.21338. G-CSF market growth based on IQVIA data and DDM MD data Q3 ‘16 to Q2 ’18. Standardized G-CSF units
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