Download Athersys, Inc. Overview 2016 Stifel Healthcare Conference

Athersys,
Inc. Overview
2016 Stifel
Healthcare
Conference
Gil Van Bokkelen - Chairman & CEO
Presented by: Rob Perry
VP, Head of NASDAQ:
Product Supply
and
ATHX
Operations
www.Athersys.com
November 16th, 2016
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Athersys: Brief Overview & Highlights
Public company in U.S. since 2007 (NASDAQ:ATHX)
Committed to developing novel and “best in class” therapies that
address substantial unmet medical needs
Primary focus: Practical & Scalable Regenerative Medicine
‒
MultiStem®: A novel & proprietary cell therapy formulated for “off-the-shelf” use
(e.g. pharmacy freezer to IV bag to patient)
‒
Biologic with multiple mechanisms of action
‒
Currently: 6 clinical stage programs & broad preclinical pipeline
‒
Highly scalable  Essential to successful commercialization
‒
Broad IP estate (>130 patents)
Therapeutic areas of concentration
‒
Neurologic
‒
Cardiovascular
‒
Inflammatory & Immune
‒
Other programs
3
Product Profile
MULTISTEM® CELL THERAPY
Based on Proprietary
MAPC Technology
Promotes Healing and
Tissue Repair
Administered Systemically
or Locally
Long Storage Life and
High Production Yield
Off the shelf administration
with no tissue matching or
immune suppression required
Works through multiple
mechanisms of action
Intravenous, catheter,
injection, matrix/implant
> 7 years of stability data,
and millions of doses from
each donor
4
Practical: Simple to Prepare &
Easy to Administer
Hospital Pharmacy to Patient in < 1 hour
5
Highly Scalable: A Competitive Advantage
Distinctive and Robust Expansion Profile + Integration with Advanced
Bioreactor Technology Enables Unprecedented Commercial Scale
Traditional 2D
Culture
3D Bioreactors
Commercial Scale
Bioreactors
6
Enhancing Healing Through Multiple
Mechanisms
Shifting the Balance in Repair Processes
Immunomodulation
Inflammation
Reduction
Angio/Vasculogenesis
MultiStem expresses multiple therapeutic
proteins & factors that limit tissue damage,
promote repair & enhance healing
Neuroprotective /
Cytoprotective
7
Development Status of Key MultiStem Programs
(Consistent Safety Data Accelerates Broader Development Options)
Neurological
Preclinical
Phase I
Phase II
Recent Data
Recent Data
Multiple Sclerosis
BLA
Study Complete - One year
results presented at ISC 2016
and Stroke 2016 Japan
CTN Accepted by PMDA
SPA Granted by FDA
Ischemic Stroke*
Traumatic Brain Injury
Phase III
Recent Data
Spinal Cord Injury
Cardiovascular
Phase 2 Underway
NHLBI Clinical Grant Award to Support Trial
Site & patient recruitment ongoing
Acute Myocardial Infarction
PVD/PAD/CLI
Congestive Heart Failure
Inflammatory & Immune
Inflammatory Bowel Disease
HSC Transplant / GVHD
Orphan Status Granted
Solid Organ Transplant
Trial active in Germany
Pulmonary (ARDS)
* In partnership with
Registrational Trial authorized by FDA under
SPA, EMA (Orphan Designation in U.S., E.U.)
Trial Underway (UK & US)
in Japan
Currently 6 Clinical Programs (4 in/at mid-late stage Clinical Development)
8
Treating Neurological Injury & Disease w/ MultiStem
IV Administration to Promote & Accelerate Healing & Repair
Work conducted in multiple preclinical models
 Ischemic Stroke
Supported by StrokeMAP
 Traumatic Brain Injury (TBI)
Supported by NIH
Acute
Neurological
Injury
 Neonatal Hypoxic Ischemia
Supported by NIH
 Spinal Cord Injury
Supported by Third Frontier
 Multiple Sclerosis
Supported by Fast Forward, MS Society
 Parkinson’s Disease
Supported by Michael J. Fox Foundation
Also: Orphan status granted by FDA for MPS-1 (Hurler’s Syndrome)
9
Opportunity for Cell Therapy in Ischemic Stroke
Ischemic stroke represents a major unmet need – and a high priority
for healthcare systems in U.S., EU and Japan and other regions
Leading cause of serious disability and
third leading cause of mortality globally
Ischemic Stroke
Example:
Damaged area
Clot or plaque
Annually ~800,000 first time stroke
victims in U.S., >2.2 Million (U.S. + EU +
Japan), and 16.9 M globally
Tremendous unmet need: tPA must be
administered within 3 – 4.5 hours of
ischemic stroke & thrombectomy within
6 hrs (combined, currently used on <10%
of ischemic stroke patients)
With an expanding aging population
globally (and increasing obesity in U.S.),
the clinical need and commercial
opportunity are expected to increase
dramatically in years ahead
10
Intravenous MultiStem for Stroke: How it works
Ischemic
Stroke
MultiStem works through regulation of multiple factors and
pathways important to brain recovery following stroke
(i.e. downregulates neuroinflammation & upregulates repair)
(1) Following a stroke a hyperinflammatory response is
initiated resulting in exacerbation of tissue loss & scarring
in brain (preventing recovery) – much of this response
emanates from the spleen (a key immune organ)
(2) Intravenous
administration of
MultiStem
(3) Cells migrate to spleen and peripheral
immune system, and to lesser extent, the brain
and other locations
(4) Simultaneous downregulation of inflammatory
cascade and upregulation of reparative immune
response & other repair mechanisms
11
Following a stroke major inflammatory damage
in the brain occurs (originating from the spleen)
In preclinical models of ischemic stroke, removing the spleen before a surgically induced stroke significantly reduces
the hyperinflammatory damage that occurs in the brain - but creates permanent immunological impairment.
Fluoro-Jade Stain
Major
loss of brain tissue
following MCAO stroke
Significantly less
brain damage
occurs when
spleen is removed
prior to stroke
Nissl Stain
Note: MCAO = Middle
Cerebral Artery Occlusion
(i.e. ischemic stroke)
Ajmo et al., (2008). J Neurosci Research 86: 2227-2234.
12
Intravenous MultiStem Mediates Dynamic Factor /
Pathway Regulation in Preclinical Stroke Models
Expression Profile - Brain (3 Days Post Stroke)
Following IV MultiStem administration:
Key Factors & Pathways Upregulated
•
•
•
•
•
Neuron projection development
Neuron differentiation
Neurogenesis
Nervous system development
Cell projection organization
Key Factors & Pathways Downregulated
Stroke – MultiStem #6
Sham Injured #3
Stroke – MultiStem #5
Sham Injured #2
Stroke – MultiStem #4
Sham Injured #1
Stroke – MultiStem #3
Stroke – MultiStem #2
Stroke – MultiStem #1
Stroke – Veh. #3
Stroke – Veh. #2
Stroke – Veh. #1
•
•
•
•
•
•
•
•
•
Inflammatory response
T cell activation
Immune response
Lymphocyte activation
Acute inflammatory response
Leukocyte activation
Response to wounding
Cell activation
Myeloid leukocyte differentiation
13
MultiStem Stroke Clinical Trial
Results from MASTERS-1
MultiStem Administration for Stroke Treatment and Enhanced Recovery Study
14
Study Sites Participating in B01-02 Trial
Glasgow (2)
Newcastle (1)
Stoke (1)
London (2)
33 Leading international stroke treatment centers across the U.S. and U.K.
15
Summary Interim Safety Results
Favorable tolerability and safety profile through evaluation date,
evaluated through at least 90 days for all patients
– No infusional or allergic reactions, and no abnormal patterns in safety labs or
vital signs
– Adverse events consistent with expectations and experience for stroke
patients of this type
Lower mortality observed for MultiStem-treated vs Placebo
treated patients
‒ Through day 30 assessment = 4 deaths for placebo group vs. 1 death for
MultiStem group
‒ Total cumulative = 9 deaths for placebo group vs. 4 deaths for MultiStem
group
Lower rate of life threatening adverse events and death
Lower rates of pulmonary events and infections among
MultiStem treated patients vs. placebo treated patients
16
Key Midstream Modifications to B01-02 Protocol
In accordance with the original B01-02 study protocol, patients were initially
treated 24 – 36 hours post stroke
– First 24 hours post stroke used to identify and exclude patients experiencing meaningful
spontaneous recovery (e.g. due to a TIA or small focal stroke) or treatment related
improvement
– Trial focus was on patients with significant and durable deficits
Consistent with the longstanding clinical maxim that “time is brain”,
preclinical data showed that earlier intervention is more effective than later
intervention (i.e. treatment at one day post stroke is more effective than
two days, several days or a week post stroke)
However…limited hours of operations at Bone Marrow transplant cell
processing centers (typically open M – F from 8:00 AM – 4:00 PM) meant we
were missing a huge proportion of patients eligible for the trial
To overcome this, we extended treatment window from 36 hours to 48
hours post stroke
Note: This will not be a limitation for future studies
November 28, 2016
17
Summary Interim Efficacy Results (All subjects)
For all subjects, initial review suggested no statistically significant
difference in primary endpoint (Global Statistic) or key secondary
endpoints
However…promising signs of benefit in multiple clinically relevant
indicators, including higher proportion of MultiStem treated
patients achieving Excellent Outcome or Excellent/Good Recovery
at day 90 (i.e. requiring improvement in all three clinical rating scales)
‒ Excellent Outcome: MultiStem = 15.4% vs placebo = 6.6%
∆8.8%
‒ Excellent or Good Recovery: MultiStem = 30.8% vs placebo 24.6%
∆6.2%
‒ Excellent neurological outcome: MultiStem = 38.5% vs Placebo = 29.5% ∆9.0%
‒ Shorter hospitalization: MultiStem = 7.9 days vs placebo 9.8 days
∆(18.6%)
‒ Evidence of faster recovery in MultiStem treated patients
Significantly reduced rates of circulating immune cells (CD3+ T cells)
at day 2 post treatment in MultiStem vs. placebo-treated patients
(p = 0.001) – consistent w/ key aspect of therapeutic hypothesis
18
Evidence of Accelerated Patient Recovery
Following MultiStem Treatment
MultiStem
Placebo
MS≤36 vs All Placebo
MS≤36 vs Placebo*
Proportion with
mRS<=2
Proportion w/
improved NIHSS ∆≥75%
Proportion with
Barthel Index ≥95
*Excludes patients receiving tPA and Mechanical Reperfusion
19
Earlier Administration of MultiStem Associated
with Reduced Acute Hospitalization & ICU Time
Hospitalization and Time in Intensive Care Unit (ICU) was
substantially reduced among patients receiving earlier treatment
with MultiStem (i.e. <36 hours)
Clinical Metric
MultiStem ≤36h
n = 27 *
Placebo
n = 52 *
Difference
(per patient)
% Reduction
(p value)
Duration of hospitalization
(days)
6.7
10.3
3.6 days
-35.0%
(p = 0.009)
Duration of ICU (days)
3.0
4.8
1.8 days
-37.5%
(p = 0.09)
* As specified in original trial design, analysis includes patients that received either no reperfusion therapy, non-responder tPA or mechanical
reperfusion (MR) patients in addition to investigational product (i.e. excludes limited number of subjects receiving both tPA and MR)
20
Final B01-02 Trial Results: Early Treatment w/
MultiStem Shows Significant Benefit at One Year
Proportion of Subjects Achieving Excellent Outcome Increases Over Time
(Patients Achieving NIHSS 0 or 1 and mRS 0 or 1, and Barthel Index >95)
Day 90
ITT (All Subjects)
MultiStem
(n=65)
Placebo
(n=61)
15.4%
vs.
6.6%
Early MultiStem
Treatment (<36 Hrs) vs
All Placebo
MultiStem
(n=31)
Placebo
(n=61)
16.1%
vs.
6.6%
Early MultiStem
Treatment (<36 hrs) vs
Placebo*
MultiStem
(n=27)
Placebo
(n=52)
18.5%
vs.
3.8%
∆ at Day
90
Day 365
∆ at Day
365
8.8%
23.1%
vs.
8.2%
14.9%
p = 0.02
9.5%
29.0%
vs.
8.2%
20.8%
p < 0.01
14.7%
29.6%
vs.
5.8%
23.8%
p < 0.01
* As specified in original trial design, analysis includes patients that received either no reperfusion therapy, non-responder tPA or mechanical
reperfusion (MR) patients in addition to investigational product (i.e. excludes a limited number of subjects receiving both tPA and MR)
21
Significantly Extending the Window to Treat
Stroke Patients
0
Tissue Plasminogen
Activator (tPA)
Mechanical
Thrombectomy
Time (in hours) to Give Stroke Treatment
3 to 4.5 hours
6 hours
36
Relevant to ≤ 10%
Stroke patients
36 hours
MultiStem® Therapy
Relevant to potentially 90-95% of stroke patients
22
Additional Clinical Observations from the
B01-02 Stroke Study
Among the most severely disabled stroke patients, a substantial reduction
observed in serious and life threatening adverse events
Severe Stroke (NIHSS 15+) Subjects
% Subjects with Grade 3-5 Adverse
Events Through Day 30
Events
MultiStem
n=26
4%
Placebo
n=23
In the aftermath of a severe stroke, patients are
highly susceptible to a range of severe and
potentially life threatening complications
• Incr. WBCs
•
•
•
•
•
43%
0%
10%
20%
30%
40%
Acute Resp. Fail.
Sepsis
Acute Renal Fail.
Edema
Herniation
50%
23
Confirmatory Biomarker Data: Administration of MultiStem
Results in Profound Reduction in Inflammatory Cascade
Intent-to-Treat Population
Difference in Fold Change at Day 7
Cytokine
Day 7, p-value
IL-1β
0.01
TNFα
0.03
IL-6
0.01
IL-12
0.12
INFγ
0.03
IL-2
0.11
Note: Evaluating available data from ITT population; controlling
for differences in baseline values, and missing values
Aggregate Fold Change from Baseline
Through Day 30
**
* p<0.01
≥1 day poststroke
24
Summary of Phase 2 Stroke Trial Results
Administration of IV MultiStem is safe and well tolerated in patients that have suffered
ischemic stroke
‒
Encouraging and consistent signs of efficacy in multiple parameters
Similar to early tPA trials and other studies, evidence that early administration provides a
robust therapeutic benefit
‒
Potential to meaningfully extend the clinical treatment window up to ~36 hours (vs current window of 3 – 4.5
hours for tPA, 6 hours for Mechanical reperfusion)
‒
Supported by preclinical studies suggesting earlier administration more effective than later administration
(within range of 1 to 2 days)
‒
Consistent with benefit of early intervention using other forms of treatment
When evaluating all trial subjects statistically significant benefit observed at one year for
Excellent Outcomes in MultiStem treated patients vs subjects receiving placebo
‒ Outstanding improvements also seen in key parameters of independent living (e.g. excellent Barthel
Index outcomes)
‒ Rates of improvement even higher among patients receiving treatment with MultiStem within 36
hours
Biomarker analysis provides direct mechanistic support (e.g. impact on circulating
immune cells, inflammatory cytokines)
Current focus is on initiating next phase of clinical development in Japan and in North
America and European Union
25
Overview of Stroke in Japan
Stroke represents a huge healthcare challenge in Japan
 Stroke is the most prevalent cardiovascular disease
in Japan  Leading cause of serious disability
o Current annual incidence of first time ischemic
strokes in Japan is ~250k - 340k cases per year
(Govt estimates, Datamonitor)
o Most susceptible segment of population is increasing
in size due to major demographic shift: Population
cohort over age 65 will double over ~20 years
o Population cohort over age 80 will increase from 6%
of population to more than 14%
 Successful engagement related to advancing
MultiStem stroke clinical program in Japan
o PMDA has accepted CTN for confirmatory trial
(September, 2016)
o High degree of clinical investigator enthusiasm
 Once approved: Efficient reimbursement pathway
o Highly centralized process, defined & efficient path
o Applies universally to all payer groups in Japan
26
Traditional Approach
New Framework
27
Regenerative Medicine Alliance
HEALIOS K.K. Overview
‒ An emerging leader in regenerative medicine in Japan
‒ Experienced and accomplished leadership team (with proven product
development experience)
‒ Robust pipeline (and one commercial product)
‒ Solid network of institutional partners
and collaborators
‒ Public company with strong balance sheet
(Tokyo Stock Exchange: 4593)
28
 Initial Phase
Alliance Structure & Key Terms
‒ Healios obtains:
o Exclusive license to MultiStem for ischemic stroke in Japan (ATHX will supply manufactured
product)
o Rights to utilize MAPC technology in organ bud area for liver transplantation and other
organ bud related research activities
‒ Athersys receives:
o $15 million license fee
o Ability to earn $30 million in development and approval milestones
o Potential to earn additional $185 million upon successful achievement of substantial sales
milestones
o Double digit royalties that escalate with sales levels
 Expansion Phase
‒ Healios option to expand MultiStem license to include 2 additional indications in Japan
(following data from ARDS study) and expanded license to MAPC for organ bud field
‒ Athersys to receive $10 million upon option exercise + potential for additional milestones,
royalties
29
Clinical Development Program for Stroke
• Cortical
• Moderate to
Severe
• Treated within
36 hours
Japan Study
CTN Accepted by PMDA
2016-2018
North America / EU Study
SPA Granted by FDA
Approximately
30-40% of
ischemic strokes
Pursue accelerated approval
pathways (e.g., Japan), and
other regulatory designations
where appropriate
(e.g. SPA = Special Protocol
Assessment)
Expand Clinical & Commercial Scope
2018 Confirmatory / Pivotal study(ies)
Indication Expansion: severity; noncortical; treatment window; dosing
Other acute neurological indications
30
Significance of Special Protocol
Assessment (SPA)
Represents a Major De-risking Event
– SPA = Written agreement between FDA and sponsor specifying precise
criteria for approval
– Establishes a clear, efficient path to success - no uncertainty about
acceptability to FDA (Primary endpoint, key secondary endpoints,
operational and statistical approach clearly specified and agreed to)
Key Elements of Trial
‒ 300 patient study to be conducted in the U.S., EU (and UK), Canada
‒ Administration within 18 – 36 hours, straightforward two arm trial (1:1)
‒ Uses established regulatory benchmarks (Primary = mRS shift at 90 days,
Key secondary endpoints = Excellent Outcome at 90 days, one year)
Provides clarity for investors, potential partners
‒ Success in this pivotal study provides potential basis for approval
‒ Historically two very large pivotal studies would typically be required
(e.g. where significant safety issues may exist and/or modest efficacy signal)
31
Cardiovascular
Disease
32
Projected Increase in Costs Due to Cardiovascular
Disease (2010 – 2030 U.S. Only)
Note: Annual incidence of acute myocardial infarction in Japan =
162,000 cases per year (Datamonitor)  Rising to >200,000 by 2027
33
MultiStem®: Acute Myocardial Infarction
Administration of MultiStem following a heart attack
Opportunity to improve
outcomes & reduce risk
of progression to CHF
Blockage causing
ischemia
Angioplasty to
clear blockage
Delivery of
MultiStem
Rapid, efficient delivery of cells to ischemic area
Retention of cells in relevant region of heart
Multiple mechanisms of action, safe & well tolerated
5 sec
30 sec
60 sec
Imaging data obtained from first patient enrolled in Phase 1 clinical trial – treated at Cleveland Clinic
Vessel patency
34
Highlights from AMI (STEMI) Clinical Trial at One Year
 Results: Excellent safety profile observed through one year in Phase 1 trial (open label)
 Efficacy: Meaningful improvements seen in LVEF, stroke volume, wall motion
Note: $2.8 Million in funding provided from NIH to support Phase 2 NSTEMI Trial
Stroke Volume
Ejection Fraction
40
*
30
4 month
12 month
*
*
∆LVSV
20
10
0
-10
-20
* Statistically significant improvement over baseline p = <0.05
Reg
20M
50M
100M
* Statistically significant improvement over Registry group p = <0.01
Evaluation of pre-specified target patient population (baseline LVEF of >30 – <45 at time of MultiStem administration)
See published Results from Phase 1 Clinical Study (Circ Research Jan. 2012, Penn et al)
35
Phase 2 Clinical Trial in Acute Myocardial Infarction
Patient recruitment ongoing
– Initial focus is on key sites in the United States
– Also evaluating potential international sites
Trial is focused on most common type of myocardial infarction
(NSTEMI)
– STEMI incidence has been declining in recent years
– NSTEMI incidence has been relatively stable, but expected to increase further with
aging demographics and other factors (i.e. increased rates of obesity, diabetes)
– NSTEMI results in higher short term mortality (e.g. 30 day) and 1 year mortality
(~25% mortality at one year) compared to STEMI (~12% mortality at one year)
Clinical assessment
– Primary efficacy: myocardial perfusion as determined by MRI at 4 months
– Also evaluating MACE and QOL assessment (e.g. EQ5D)
– Evaluating improvement in multiple cardiovascular performance parameters
(including LVEF, LV dimensions)
36
Pulmonary
Disease
37
Opportunity in Pulmonary Medicine
Acute Respiratory Distress Syndrome (ARDS) afflicts >200,000 individuals in
North America, >275,000 in EU and >70,000 people in Japan annually
– ARDS represents a major area of unmet medical need, with a high rate of mortality and high
level of morbidity, and typically requires extended intensive care hospitalization (e.g. ICU)
– Very high cost of care and QOL impact  Another multibillion $ market opportunity
Athersys and collaborators have evaluated potential of MultiStem in
pulmonary area  Exploratory clinical trial has been initiated
£2 Million in funding obtained for clinical development in U.K. (w/ additional
funding from NIH)
MultiStem conveys multiple mechanisms relevant to acute pulmonary
inflammatory damage
– Product naturally distributes to pulmonary system
– Downregulation of acute inflammatory pathways
– Upregulation of reparative cell types and pathways
Clinical assessment
– Evaluating functional improvements as well as impact on
morbidity and mortality
– Also evaluating QOL and other parameters
38
MultiStem reduces inflammation in human
lungs with ischemic reperfusion injury
39
Key Milestones
Partnering activities
‒ Development partnership in Japan for stroke (and potentially other indications) (Completed)
‒ Actively exploring other potential partnering opportunities
Advancing Key Clinical Programs
‒ Japan Stroke Clinical Program
o Obtain PMDA Regulatory Authorization (Completed)
o Initiation of enrollment
o Completion of enrollment
o Top Line Results  Seek Accelerated Approval Upon Positive Results
‒ North America + European Union Stroke Clinical program
o End of Phase 2 meeting (Completed)
o Finalize U.S. + E.U. trial study design and obtain authorization for international Phase 3 trial  SPA defines a highly
efficient path to potential approval (FDA: SPA Completed – EMA in process)
o Initiate study
‒ Complete enrollment of ongoing AMI, ARDS clinical trials
Continuing advancement toward “Commercial Readiness”
40
Summary Financial Data
$ Thousands
Nine Months ended
September 30, 2016
Revenues
$ 16,364
Operating expenses, net of insurance gain*
(23,147)
Expense from change in fair value of warrants
and other income, net
(1,427)
Net loss
$ (8,210)
Net cash used in operating activities
$ (4,647)
Net cash provided by financing activities
(includes equity purchase agreement issuances and
warrant/option exercises)
Cash and Investments
$
2,130
$ 19,379
*Insurance proceeds related to storm damage resulted in $682k gain; repairs completed Q3
41
Athersys,
Inc. Overview
2016 Stifel
Healthcare
Conference
Gil Van Bokkelen - Chairman & CEO
Presented by: Rob Perry
VP, Head of NASDAQ:
Product Supply
and
ATHX
Operations
www.Athersys.com
November 16th, 2016