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Form 8-K INFINITY PHARMACEUTICALS For: May 07

May 7, 2015 8:51 AM EDT

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d)

OF THE SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported): May 7, 2015

 

 

Infinity Pharmaceuticals, Inc.

(Exact name of registrant as specified in charter)

 

 

 

Delaware   000-31141   33-0655706

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

784 Memorial Drive, Cambridge, MA   02139
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code: (617) 453-1000

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 


Item 7.01. Regulation FD Disclosure

From time to time, we intend to conduct meetings with third parties in which our current corporate slide presentation is presented. A copy of this slide presentation, dated May 7, 2015, is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The information responsive to Item 7.01 of this Form 8-K and Exhibit 99.1 hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such a filing.

 

Item 9.01. Financial Statements and Exhibits

(d) The following exhibit is included in this report:

 

Exhibit No.

  

Description

99.1    Presentation dated May 7, 2015


SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

INFINITY PHARMACEUTICALS, INC.
Date: May 7, 2015 By: /s/ Lawrence E. Bloch, MD, JD
Lawrence E. Bloch, MD, JD
EVP, Chief Financial Officer and
Chief Business Officer
Building a Fully Integrated
Biopharmaceutical Company
May 7, 2015
Exhibit 99.1


Forward-Looking Statements
This
presentation
contains
forward-looking
statements
within
the
meaning
of
The
Private
Securities
Litigation
Reform
Act
of
1995.
Such
forward-
looking
statements
include
those
regarding
the
Company’s
expectations
about:
its
plans
to
complete
patient
enrollment
in
DYNAMO
and
DUO
in
the
second
half
of
2015;
plans
to
initiate
additional
studies
of
duvelisib
in
2015;
its
ability
to
execute
on
its
strategic
plans;
the
potential
complementary
effects
of
inhibiting
PI3K-delta
and
PI3K-gamma;
the
therapeutic
potential
of
PI3K
inhibition
and
duvelisib,
including
in
combination
with
venetoclax;
market
size;
and
2015
financial
guidance.
Such
statements
are
subject
to
numerous
important
factors,
risks
and
uncertainties
that
may
cause
actual
events
or
results
to
differ
materially
from
the
company’s
current
expectations.
For
example,
there
can
be
no
guarantee
that
Infinity
will
report
data
in
the
time
frames
it
has
estimated,
that
any
product
candidate
Infinity
is
developing
will
successfully
complete
necessary
preclinical
and
clinical
development
phases,
or
that
development
of
any
of
Infinity’s
product
candidates
will
continue.
Further,
there
can
be
no
guarantee
that
Infinity's
strategic
collaboration
with
AbbVie
will
continue
or
that
any
positive
developments
in
Infinity’s
product
portfolio
will
result
in
stock
price
appreciation.
Management’s
expectations
and,
therefore,
any
forward-looking
statements
in
this
press
release
could
also
be
affected
by
risks
and
uncertainties
relating
to
a
number
of
other
factors,
including
the
following:
Infinity’s
results
of
clinical
trials
and
preclinical
studies,
including
subsequent
analysis
of
existing
data
and
new
data
received
from
ongoing
and
future
studies;
a
failure
of
Infinity
and/or
AbbVie
to
fully
perform
under
the
strategic
collaboration
and/or
an
early
termination
of
the
collaboration
and
license
agreement;
the
content
and
timing
of
decisions
made
by
the
U.S.
FDA
and
other
regulatory
authorities,
investigational
review
boards
at
clinical
trial
sites
and
publication
review
bodies;
Infinity’s
ability
to
obtain
and
maintain
requisite
regulatory
approvals
and
to
enroll
patients
in
its
clinical
trials;
unplanned
cash
requirements
and
expenditures;
development
of
agents
by
Infinity’s
competitors
for
diseases
in
which
Infinity
is
currently
developing
or
intends
to
develop
its
product
candidates;
and
Infinity’s
ability
to
obtain,
maintain
and
enforce
patent
and
other
intellectual
property
protection
for
any
product
candidates
it
is
developing.
These
and
other
risks
which
may
impact
management’s
expectations
are
described
in
greater
detail
under
the
caption
“Risk
Factors”
included
in
Infinity’s
quarterly
report
on
Form
10-Q
filed
with
the
Securities
and
Exchange
Commission
(SEC)
on
May
6,
2015,
and
other
filings
filed
by
Infinity
with
the
SEC.
Any
forward-looking
statements
contained
in
this
press
release
speak
only
as
of
the
date
hereof,
and
Infinity
expressly
disclaims
any
obligation
to
update
any
forward-looking
statements,
whether
as
a
result
of
new
information,
future
events
or
otherwise.
Infinity’s
website
is
http://www.infi.com.
Infinity
regularly
uses
its
website
to
post
information
regarding
its
business,
product
development
programs
and
governance.
Infinity
encourages
investors
to
use
www.infi.com,
particularly
the
information
in
the
section
entitled
“Investors/Media,”
as
a
source
of
information
about
Infinity.
References
to
www.infi.com
in
this
presentation
are
not
intended
to,
nor
shall
they
be
deemed
to,
incorporate
information
on
www.infi.com
into
this
presentation
by
reference.
2


Infinity Today
3
Growing Hem/Onc
Market with Unmet
Medical Need
Commitment to
Building a Novel
Pipeline
Key Strategic
Partner 
Registration
Focused Studies
Underway
Experienced
Team
Duvelisib
1
st
in Class Dual
Inhibitor of PI3k-


4
Current Landscape
An estimated 1.1M
people in the U.S. are
either living with, or
are in remission from,
leukemia or lymphoma.
Leukemia & Lymphoma Society, Facts and Statistics 2015


5
Current Landscape
Every 10 minutes,
someone in the
U.S. dies from a
blood cancer.
Leukemia & Lymphoma Society, Facts and Statistics 2015
iNHL and CLL are incurable


Duvelisib Overview
Only dual inhibitor of PI3K-
in Phase 3 development
Broad activity observed from Phase 1 study in advanced
hematologic malignancies
1
Early evidence of durability in patients with
relapsed/refractory iNHL and CLL
2
Registration-focused studies ongoing
6
1
Flinn et al., ASH 2014 Phase 1 data; O’Brien et al., ASH 2014 Phase 1 data; Porcu et al., ASH 2014
Phase 1 data; Horwitz et al., T-Cell Lymphoma Forum 2015 Phase 1 data.
2
Flinn et al., ASH 2014 Phase 1 data; O’Brien et al., ASH 2014 Phase 1 data.


Follicular Lymphoma (FL) Market Growth
7
44,000 drug-treated FL patients
Growth Drivers
Growing and aging
population
Increased number of
approved treatments
Availability of oral treatment
options
Longer duration of treatment
Availability of chemo-free
treatment options, including
novel combinations
Markets include: US, EU5, and Japan
Source: Decision Resources 2012


The Need for New Treatment Options in FL
8
Newly
Diagnosed
Relapsed
Relapsed/
Refractory
Source: Product prescribing information; physician interviews
More
effective
treatment
options
for
frail
patients
Cure, increase minimal residual disease
negativity
Longer remissions
Deeper responses and complete responses
Improved tolerability profile
Effective treatment options that preserve
patient QoL
Unmet Need
Current Therapy
R-CHOP
R-CVP
BR
R-mono
R-chemo
R-mono
R-chemo
R-mono
Idelalisib


DYNAMO™: Opportunity to Provide a New
Treatment Option for Refractory iNHL Patients
9
Open-label, single-arm monotherapy study under way
Primary endpoint: Objective response rate
Enrollment completion anticipated 2H15
Regulatory support for potential accelerated approval
*Includes follicular lymphoma, marginal zone lymphoma, small lymphocytic lymphoma.
Duvelisib dosed at 25 mg BID; Clinicaltrials.gov NCT01882803.
~120 iNHL
patients*
duvelisib


DYNAMO+R: Opportunity to Provide a New
Treatment Option for Relapsed FL Patients
10
Randomized, placebo-controlled combination study
Primary endpoint: Progression-free survival
Regulatory support that DYNAMO+R could serve as confirmatory
trial for DYNAMO
~400
Patients
with
Relapsed FL
duvelisib + Rituxan
®
placebo + Rituxan
®
Duvelisib dosed at 25 mg BID; Clinicaltrials.gov NCT02204982.


Duvelisib Active in Relapsed/Refractory Indolent
Non-Hodgkin Lymphoma (R/R iNHL): 72% ORR*
11
72% (13/18) ORR, including 33% (6/18) CR, at 25 mg BID
69% (9/13) ORR in follicular lymphoma patients, including 38% (5/13) CR
Majority of adverse events Grade 1 or 2, reversible and clinically manageable
Flinn et al., ASH 2014 Phase 1 data.
*25 mg BID dose.


Early Evidence of Durability in R/R iNHL
Median PFS Not Reached
12
Flinn et al., ASH 2014 Phase 1 data.
*25 mg BID dose.
69% progression-free at 24 months*


Early Evidence of Durability in R/R iNHL
Median OS Not Reached
13
Flinn et al., ASH 2014 Phase 1 data.
*25 mg BID dose.
89% survival at 24 months*


CONTEMPO: Addressing First-Line Therapy in FL
14
Phase 1b/2 study in ~120 patients with previously untreated FL
Primary objectives:
Confirm safety of the combinations
Assess clinical activity
Phase 1b Safety Lead in:
duvelisib + Gazyva
®
duvelisib + Rituxan
®
Phase 2:
duvelisib + Gazyva
®
Phase 2:
duvelisib + Rituxan
®


Novel Targeted
Combinations
4
duvelisib + venetoclax
1
st
Line
Development
3
Duvelisib Development Strategy in iNHL
15
Improve Upon
and/or Replace
Chemotherapy
2
Initiate two clinical studies in 2015
Initial Registration
Studies:
Refractory and
Relapsed
1


CLL Market Growth
16
*Includes SLL
Markets include: US, EU5, and Japan
Source: Decision Resources 2012
56,000 drug-treated CLL* patients
Growth Drivers
Growing and aging
population
Increased number of
approved treatments
Availability of oral treatment
options
Longer duration of treatment
Availability of chemo-free
treatment options, including
novel combinations


The Need for New Treatment Options in CLL
17
*Indicated in first-line for CLL patients with 17p deletion
Source: Product prescribing information; physician interviews
Newly
Diagnosed
Relapsed
Relapsed/
Refractory
Unmet Need
Improved overall survival
More
effective
treatment
options
for
frail
patients
Low MRD, cure
Longer remissions
Deeper responses and complete responses
Shorter time to response
Effective treatment options that preserve
patient QoL
Current Therapy
FCR
BR
R-mono
Ibrutinib*
R-chemo
R-mono
Ibrutinib
R-chemo
R-mono
Ibrutinib
Idelalisib + R


Randomized, monotherapy study
Primary endpoint: Progression-free survival by
independent review
Completion of enrollment expected in 2H15
Duvelisib dosed at 25 mg BID; Clinicaltrials.gov NCT02004522.
~300 patients
duvelisib
(n = ~150)
Arzerra
®
(ofatumumab)
(n = ~150)
DUO™: Opportunity to Provide a New Treatment
Option for Relapsed/Refractory CLL Patients
18


Duvelisib Monotherapy Active in R/R CLL: 57% ORR*
19
57% ORR by IWCLL at 25 mg BID, including 1 CR
83% (25/30) nodal response rate (
50% reduction in adenopathy)
Adverse
events
were
mostly
Grade
1
or
2,
reversible
and
clinically
manageable
O’Brien et al., ASH 2014 Phase 1 data.
*25 mg BID dose.


Early Evidence of Durability in R/R CLL
Median PFS Not Reached*
20
66% progression-free at 12 months*
59% progression-free at 24 months*
O’Brien et al., ASH 2014 Phase 1 data.
*25 mg BID dose.


Early Evidence of Durability in R/R CLL
Median OS Not Reached*
21
74% survival at 12 months*
63% survival at 24 months*
O’Brien et al., ASH 2014 Phase 1 data.
*25 mg BID dose.


Duvelisib Shows Early Evidence of Activity in
Patients Previously Treated with Ibrutinib
CLL (N = 6): 1 PR, 5 SD
Aggressive NHL (N = 5): 2 PR, 1SD, 2PD
Adverse event profile similar to larger Phase 1 study population
22
Porcu et al., ASH 2014 Phase 1 data; O’Brien et al. ASH 2014 Phase 1 data; Campbell et al. ASH 2013 Phase 1 data.


SYNCHRONY: Anticipating a Growing Medical Need
for CLL Patients Relapsing on BTK Inhibitor Therapy
23
Phase 1b, open-label, dose-escalation study in ~60 CLL
patients whose disease has progressed following
treatment with a BTK inhibitor
Objectives: Determine doses, evaluate clinical activity
and safety
Clinicaltrials.gov NCT02292225
Dose-Escalation Phase:
duvelisib + Gazyva
®
Expansion Phase:
duvelisib + Gazyva
®


CLL Cells From Duvelisib Treated Patients “Primed”
for Apoptosis
24
Patel et al., AACR 2015.
BIK
BIM
BMF
HRK
NOXA
PUMA
BCL-2
BH3-only protein
Pro-apoptotic
Pro-survival
protein
anti-apoptotic


Rationale For Combining Duvelisib with Venetoclax
25
Cells from Patients Treated with Duvelisib Show Increased Sensitivity
to Ex-Vivo Venetoclax Treatment
Patel et al., AACR 2015.
N=5
Paired t test
p=0.0041


Duvelisib Development Strategy in CLL
26
Initial Registration
Study:
Relapsed or Refractory
1
Novel Targeted
Combinations
3
duvelisib + venetoclax
First and Best
Treatment Post
BTK Inhibitor
2


Strategic Partnership with AbbVie for Duvelisib
in Oncology
27
$275M up-front payment
$530M in potential development and commercial milestones
Up to $405 million for the achievement of milestones
through first commercial sale
Infinity will fund the trials it conducts, up to $667 million,
after which costs will be shared equally
Infinity and AbbVie will equally share funding for trials
conducted by AbbVie
Co-promotion and 50/50 profit share in U.S.
Tiered royalty payments ex-U.S., ranging from 23.5% to
30.5% of net sales
Financial
Development
Commercial
Partnership Terms:


2015 Financial Guidance
(as of May 6, 2015)
Cash and investments at 3/31/15 (unaudited):
$233.6M
Revenue:
$105M-$125M
Net loss:
$190M-$210M
Year-end cash and investments:         
$145M-$165M
28
2015 financial revenue guidance assumes receipt of a $130 million milestone payment from AbbVie Inc. associated with the first anticipated
completion of enrollment in either DYNAMO or DUO; financial guidance is based on current operating plan and exclusive of any business
development activities.


Anticipated 2015 Milestones
Novel Duvelisib Combinations
Initiate first clinical study of duvelisib in combination with venetoclax*
Duvelisib in iNHL
Complete enrollment in DYNAMO
TM
in 2H’15
Initiate
2 additional clinical studies
Duvelisib in CLL
Complete enrollment in DUO
TM
in 2H’15
29
*AbbVie is responsible for this study.


Building a Fully Integrated
Biopharmaceutical Company
www.infi.com
Twitter: @infipharma
*
*
*
*


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