− Overall Response Rate of 28.4% Observed in
Phase 2b SADAL Study in Relapsed/Refractory DLBCL; Additional
Top-line Data to be Presented as a Late-Breaker at AACR 2017 Annual
Meeting –
Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage
pharmaceutical company, today reported financial results for the
fourth quarter and full year 2016 and provided a clinical update
for selinexor (KPT-330), its lead, novel, oral Selective Inhibitor
of Nuclear Export (SINE™) compound. The Company also provided
an overview of select accomplishments related to its other pipeline
assets, including KPT-8602, its second-generation oral SINE™
compound, KPT-9274, its oral, dual inhibitor of p21-activated
kinase 4 (PAK4) and nicotinamide phosphoribosyltransferase (NAMPT),
and KPT-350, an oral SINE™ compound with potential applications in
neurological and autoimmune indications.
“2016 marked a year of several key achievements
for Karyopharm, including the rapid advancement of oral selinexor
in relapsed or refractory multiple myeloma (MM), a disease for
which we believe we have a path to regulatory approval,” said
Michael G. Kauffman, MD, PhD, Chief Executive Officer of
Karyopharm. “To date, 2017 has brought several significant
developments. Today we announced the planned development path
for selinexor in diffuse large B-cell lymphoma (DLBCL), our second
lead indication after MM. Following the observation of a
28.4% overall response rate (ORR) in the Phase 2b SADAL study, we
consulted with the U.S. Food and Drug Administration (FDA) and
obtained their agreement to our amendment of the SADAL study to
focus solely on the 60mg twice weekly treatment cohort, in which we
plan to enroll up to 90 more patients. Assuming we continue
to see the response rate we have observed to date, we intend to use
the data from the SADAL study to support an accelerated approval in
DLBCL. We look forward to presenting additional top-line data
from the Phase 2b SADAL study in a late-breaking poster at the
upcoming American Association for Cancer Research (AACR) 2017
annual meeting in early April.”
As previously announced on March 10, 2017,
Karyopharm’s selinexor clinical trials have been placed on a
partial clinical hold by the FDA due to incomplete information in
the existing version of the investigator's brochure (IB), including
an incomplete list of serious adverse events (SAEs) associated with
selinexor. The partial clinical hold is not the result of any
patient death or any new information regarding the safety profile
of selinexor. While the partial clinical hold remains in
effect, patients with stable disease or better may remain on
selinexor therapy, but no new patients may be enrolled until the
partial clinical hold is lifted. The Company has provided all
requested materials to the FDA believed to be required to lift the
partial clinical hold. Karyopharm is working diligently with
the FDA to seek the release of the partial clinical hold and resume
enrollment in its selinexor clinical trials as expeditiously as
possible. The Company believes that its previously disclosed
enrollment rates and timelines for its ongoing trials will remain
materially unchanged.
Clinical Update for Selinexor in
DLBCL:
Today Karyopharm reported a 28.4% overall
response rate (ORR) in the ongoing Phase 2b SADAL study evaluating
60mg and 100mg of selinexor dosed twice weekly in patients with
relapsed or refractory DLBCL. In a recent analysis of the
first 63 patients between both arms, the ORR, as determined by
independent Central Radiological Review, was 28.4%, with consistent
response rates across both arms, but greater durability and
tolerability observed in the 60mg arm. As a result of these
findings, and in consultation with the FDA, the Company has decided
to amend the SADAL study protocol to become a single-arm study
focusing solely on single-agent selinexor dosed at 60mg twice
weekly, eliminating the 100mg arm. The Company will also make
certain other protocol amendments, including reducing the 14-week
washout period to 8 weeks for patients who achieved at least a
partial response on their most recent therapy. The FDA agreed
that the changes to the single-arm study were reasonable and that
the proposed trial design and indication appear appropriate for
accelerated approval, though eligibility for accelerated approval
will depend on the complete trial results and available therapies
at the time of regulatory action. The Company plans to enroll
up to an additional 90 patients to the new 60mg single-arm cohort,
and expects to report top-line results from the completed SADAL
study in mid-2018.
Dr. Kauffman continued, “Looking ahead to the
remainder of 2017, we are focusing on initiation of the pivotal
Phase 3 BOSTON trial where we will evaluate selinexor in
combination with Velcade® (bortezomib) and dexamethasone in
patients with MM previously treated with one to three regimens,
moving selinexor into much earlier lines of treatment. After
the presentation of the SADAL data at the AACR 2017 annual meeting,
we anticipate multiple other important data readouts during the
year, including top-line data from the Phase 2 portion of our
randomized Phase 2/3 SEAL study in patients with liposarcoma, our
most advanced solid tumor indication in mid-2017. We also
plan to present top-line Phase 1 safety and tolerability data for
KPT-9274 in the second half of the year.”
“Our other key objectives include continued
execution of the expanded STORM and STOMP studies in relapsed or
refractory MM. For STORM, the expansion arm evaluating oral
selinexor in patients with penta-refractory MM is expected to read
out in early 2018. Assuming a positive outcome, we intend to
use the STORM study data to support accelerated approval for
selinexor in MM. For STOMP, we recently completed enrollment
in the selinexor, Velcade® (bortezomib) and dexamethasone arm and
expect to soon initiate a new expansion arm evaluating oral
selinexor in combination with the anti-CD38 monoclonal antibody
Darzalex®,” Dr. Kauffman concluded.
Fourth Quarter 2016 and Recent Events,
Highlights and Milestones:
Selinexor in Multiple Myeloma (MM)
- Initiating Pivotal Phase 3 BOSTON Study in Early
2017. Based on the strong combination data recently
reported from the Phase 1b STOMP study, Karyopharm plans to
initiate a pivotal randomized Phase 3 study, known as the BOSTON
(Bortezomib, Selinexor and
dexamethasone) study, which will
evaluate selinexor in combination with Velcade® (bortezomib) and
dexamethasone (SVd), compared to Velcade® and low-dose
dexamethasone (Vd) in patients with MM who have had one to three
prior lines of therapy. Karyopharm has identified the
combination dose of selinexor (100mg weekly), Velcade® (1.3 mg/m2
weekly given subcutaneously for 4 of 5 weeks) and dexamethasone
(40mg weekly) to be used in the BOSTON study and expects that the
study will enroll approximately 360 patients. The Company
expects to commence the BOSTON study in early 2017.
- Expanded STORM Study to Include 122 Additional Patients
with Penta-refractory MM. The Company has expanded
the STORM study, which is expected to include 122 additional
patients with penta-refractory MM, a growing unmet medical need in
which there are no approved therapies available. Karyopharm
expects to report top-line data from the expanded cohort in early
2018, and, assuming a positive outcome, intends to use the expanded
STORM study data to support accelerated approval for selinexor in
MM.
- Completed Enrollment in STOMP Arm Evaluating Selinexor
in Combination with Velcade. In February 2017,
Karyopharm completed enrollment in the Phase 1b/2 STOMP arm
designed to evaluate selinexor in combination with the proteasome
inhibitor Velcade® and low-dose dexamethasone (SVd) in heavily
pretreated patients with MM. The SVd arm of the STOMP study
enrolled 42 patients and the Company expects to report updated data
towards the end of 2017.
- On Track to Initiate New STOMP Expansion Arm Evaluating
Selinexor in Combination with Darzalex®
(daratumumab). Karyopharm expects to dose
the first patient in a new Phase 1b/2 STOMP expansion arm designed
to evaluate selinexor in combination with the anti-CD38 monoclonal
antibody Darzalex® and low-dose dexamethasone (SDd) in heavily
pretreated patients with MM. The SDd arm of the STOMP study
is expected to enroll approximately 44 patients and the Company
expects to report top-line data in late 2017 or early 2018.
- Reported Updated STORM and STOMP Data at ASH 2016
Annual Meeting. Karyopharm presented updated
clinical data from the ongoing Phase 2b STORM study and the ongoing
Phase 1b STOMP study at the American Society of Hematology (ASH)
2016 annual meeting. The updated STORM data demonstrated that
patients treated with selinexor plus low-dose dexamethasone
achieved an overall response rate (ORR), adjudicated by an
Independent Review Committee, of 21% (n=78), and that the ORR was
similar between patients with quad-refractory (21%; n=48) and
penta-refractory (20%; n=30) disease. The updated STOMP data
showed that selinexor in combination with Velcade® (bortezomib) and
dexamethasone (SVd) produced an ORR of 77% (investigator assessed)
across all evaluable patients in the study (n=22), including
patients with MM not refractory to a proteasome inhibitor (ORR
100%; n=7) and those with disease previously refractory to a
proteasome inhibitor (ORR 67%; n=15).
- Co-hosted Expert Panel Discussion with the Multiple
Myeloma Research Foundation (MMRF) at ASH 2016 Annual
Meeting. Karyopharm and the MMRF hosted a panel discussion
featuring leading MM thought leaders at the ASH 2016 annual
meeting. Topics discussed by recognized expert panelists
included the need for new MM treatments with novel mechanisms of
action and the combinability of MM agents for synergistic
activity. A webcast replay and transcript of the panel
discussion are available at
http://investors.karyopharm.com/events.cfm.
- Presented an Overview of Clinical Data Demonstrating
Selinexor Activity in Combination with Proteasome Inhibitors and
Immunomodulatory Agents. In an oral presentation at the
International Myeloma Workshop 2017 annual meeting held March 1-4,
2017 in New Delhi, India, Karyopharm researchers presented an
overview of clinical data demonstrating selinexor’s activity in
combination with proteasome inhibitors and immunomodulatory drugs
for the treatment of relapsed or refractory MM.
Selinexor in Diffuse Large B-Cell Lymphoma
- Top-line Data from Phase 2b SADAL Study in DLBCL
Selected as a Late-Breaking Abstract at AACR 2017 Annual
Meeting. In March 2017, Karyopharm announced that an
abstract highlighting top-line data from its Phase 2b SADAL study
evaluating single-agent selinexor with dexamethasone in patients
with relapsed or refractory DLBCL was selected as a late-breaking
poster at the AACR 2017 Annual Meeting. The poster will be
presented by Marie Maerevoet, Institute Jules Bordet, Belgium, on
Tuesday, April 4, 2017 from 1:00-5:00PM ET.
Selinexor in Other Hematologic Malignancies
- Announced Outcome of Phase 2 SOPRA Interim Analysis;
Updated AML Development Strategy. In March 2017,
Karyopharm announced the results of the planned interim analysis of
the Phase 2 SOPRA study evaluating single-agent selinexor in
relapsed or refractory acute myeloid leukemia (AML). In
concert with the study’s independent Data Safety Monitoring Board
(DSMB), the Company determined that the SOPRA study would not reach
statistical significance for showing superiority of overall
survival (OS) on selinexor versus OS on physician’s choice (PC),
the study’s primary endpoint. However, since the 13% of
selinexor-treated patients who achieved a complete response with or
without full hematologic recovery (CR/CRi) showed a substantial OS
benefit as compared to PC, they will be permitted to continue on
the selinexor arm or the PC arm, as applicable, following
discussion between the patient and his or her treating physician.
Importantly, selinexor demonstrated a safety profile consistent
with previous studies. Importantly, in the selinexor arm, there
were similar rates of sepsis and lower rates of febrile neutropenia
compared with the PC arm. Karyopharm plans to continue to
explore the use of selinexor in combination with novel and standard
agents through investigator-sponsored AML studies in both adults
and children.
- Reported Final Data from Phase 2 SAIL Study in AML at
ASH 2016 Annual Meeting. Final clinical data from
the Phase 2 SAIL study evaluating selinexor in combination with
Ara-C and idarubicin demonstrated a compelling 55% ORR in heavily
pretreated patients with relapsed or refractory AML. We
believe that selinexor in combination with Ara-C and idarubicin may
be an effective AML treatment option and serve as a bridge to stem
cell transplantation in this patient population. Given the
encouraging data observed to date across these settings, Karyopharm
plans to continue clinical development of selinexor in AML through
investigator sponsored trials in multiple combination regimens,
including with chemotherapy.
- Published Clinical Data Demonstrating Selinexor’s
Activity in Pediatric Patients with Relapsed/Refractory Leukemia in
the Journal of Clinical Oncology. A paper describing
results from the investigator-sponsored SELHEM study evaluating
selinexor’s activity in pediatric patients with relapsed or
refractory leukemia were recently published in the Journal of
Clinical Oncology. In the paper, authored by Thomas B.
Alexander, et al., titled “Phase I Study of Selinexor, a Selective
Inhibitor of Nuclear Export, in Combination With Fludarabine and
Cytarabine, in Pediatric Relapsed or Refractory Acute Leukemia,”
Karyopharm collaborators report that seven of the 15 evaluable
patients, or 47%, achieved either a CR or a CRi. Five of the
responses included CRs negative for minimal residual disease (MRD)
and two patients had MRD negative CRs within the first cycle after
receiving only selinexor therapy prior to any chemotherapy. Based
on these data, Karyopharm plans to explore the benefit of selinexor
in combination with intensive chemotherapy through
investigator-sponsored Phase 2 clinical trials in pediatric
patients with heavily pretreated AML.
Selinexor in Solid Tumors
- Completed Enrollment in Phase 2 Portion of the SEAL
Study. In March 2017, Karyopharm completed
enrollment in the randomized Phase 2 portion of the SEAL study
evaluating selinexor in patients with advanced liposarcoma.
The company expects to report top-line data in mid-2017.
- Reported Final Data from Phase 2 SIGN Study in
Gynecologic Malignancies. In October 2016,
Karyopharm reported final data from its Phase 2 SIGN study
evaluating oral selinexor for the treatment of gynecological
malignancies, including ovarian, endometrial and cervical cancers,
at the European Society of Medical Oncology 2016 annual
meeting. Of the 20 evaluable patients with endometrial
cancer, 9 met the primary endpoint (3 confirmed partial responses
and 6 with stable disease of ≥12 weeks), for a disease control rate
of 45%. Median progression-free survival for the endometrial
cancer arm was 3 months and median OS was 8 months. An
investigator-sponsored Phase 3 randomized double-blind study
evaluating selinexor in patients with advanced or recurrent
endometrial cancer is in development and expected to initiate
enrollment in late 2017.
Selinexor Early Scientific Research
- Published Preclinical Data Demonstrating Selinexor
Anti-Tumor Activity in Combination with Immunotherapeutic
Agents. Two papers describing the
synergistic anti-tumor activity of selinexor in combination with
immunotherapeutic agents, including PD-1 or PD-L1 checkpoint
inhibitors, and further validating the selinexor clinical dosing
schedules, were published online in Molecular Cancer Therapeutics.
In the first paper, authored by Matthew R. Farren et al.,
titled “The exportin-1 inhibitor selinexor exerts superior
anti-tumor activity when combined with T cell checkpoint
inhibitors,” Karyopharm researchers, in collaboration with Emory
University and Ohio State University, report that selinexor
combined with immune checkpoint inhibitors, including PD-1, PD-L1
or CTLA-4 blocking antibodies, significantly limited tumor growth
in an aggressive murine model of melanoma. The reduction in tumor
growth was accompanied by systemic changes in natural killer cells,
myeloid derived suppressor cells, T cell differentiation and
increased infiltration of T cells in the tumor
microenvironment.
- In the second paper, authored by Paul M. Tyler et al., titled
“Clinical dosing regimen of selinexor maintains normal immune
homeostasis and T cell effector function in mice: implications for
combination with immunotherapy,” Karyopharm researchers, in
collaboration with the Dana-Farber Cancer Institute, University of
Amsterdam and Massachusetts General Hospital, discuss preclinical
results supporting further evaluation of selinexor in combination
with anti-PD-1 monoclonal antibodies as a potential treatment
approach for cancer patients. In this study, it was
determined that selinexor in combination with anti-PD-1 monoclonal
antibodies, dosed twice weekly is the optimal dosing schedule to
allow sufficient time for a fully functional CD8 T cell response
and development of anti-tumor immunity. Therefore, the
combination of selinexor with a PD-1 or PD-L1 checkpoint inhibitor
was predicted to have added benefit over selinexor treatment
alone.
KPT-8602
- Reported Phase 1 Clinical Data for KPT-8602 at ASH 2016
Annual Meeting. Clinical data from a Phase 1/2 study
evaluating KPT-8602, Karyopharm’s second-generation SINE™ compound,
were presented at the ASH 2016 annual meeting by Frank Cornell, MD,
Vanderbilt Ingram Cancer Center. These data demonstrated that oral
KPT-8602 was well tolerated in heavily pretreated patients with
relapsed or refractory MM and showed early signs of encouraging
efficacy.
KPT-9274
- Preclinical Data Highlighting KPT-9274’s Anti-Cancer
Activity in Dogs Selected as a Late-Breaking Abstract at AACR 2017
Annual Meeting. In March 2017, Karyopharm announced
that an abstract highlighting preclinical data demonstrating
KPT-9274’s activity and synergy with doxorubicin to treat dogs with
lymphoma was selected as a late-breaking poster at the AACR 2017
annual meeting. The poster will be presented by Cheryl
London, Tufts University, on Wednesday, April 5, 2017 from 8:00
AM-12:00PM ET.
KPT-350
- Target ALS Consortium Grants $900,000 in
Research Funding. The
Target ALS Foundation awarded a $900,000 grant to support
preclinical studies of KPT-350 in amyotrophic lateral sclerosis
(ALS). The project, led by Karyopharm in collaboration with
researchers from Johns Hopkins University and the University of
Florida, is studying KPT-350 in preclinical models and will seek to
develop an oral suspension formulation to dose patients who cannot
swallow tablets.
Fourth Quarter and Year Ended December
31, 2016 Full Year Financial Results
Cash, cash equivalents and investments as of
December 31, 2016, including restricted cash, totaled $175.5
million, compared to $210.0 million as of December 31, 2015.
For the year ended December 31, 2016, research
and development expense was $86.9 million compared to $97.7 million
for the year ended December 31, 2015. For the year ended
December 31, 2016, general and administrative expense was $23.9
million compared to $21.6 million for the year ended December 31,
2015.
Karyopharm reported a net loss of $109.6
million, or $2.92 per share, for the year ended December 31, 2016,
compared to a net loss of $118.2 million, or $3.32 per share, for
the year ended December 31, 2015. Net loss includes
stock-based compensation expense of $22.3 million and $17.1 million
for the years ended December 31, 2016 and December 31, 2015,
respectively.
For the quarter ended December 31, 2016,
research and development expense was $20.7 million compared to
$24.1 million for the quarter ended December 31, 2015. The
decrease in research and development expenses resulted primarily
from the timing of clinical expenses related to the development of
selinexor. For the quarter ended December 31, 2016, general
and administrative expense was $6.5 million compared to $5.3
million for the quarter ended December 31, 2015. Karyopharm
reported a net loss of $26.9 million, or $0.65 per share, for the
quarter ended December 31, 2016, compared to a net loss of $29.0
million, or $0.81 per share, for the quarter ended December 31,
2015. Net loss includes stock-based compensation expense of
$5.1 million and $5.4 million for the quarters ended December 31,
2016 and December 31, 2015, respectively.
Financial Outlook
Karyopharm expects its operating cash burn,
including research and development and general and administrative
expenses, for the year ending December 31, 2017 to be in the range
of $85 to 90 million. Based on current operating plans,
Karyopharm expects that its existing cash and cash equivalents will
fund its research and development programs and operations until the
end of 2018, including through the data readout for the expanded
STORM cohort, completion of enrollment for the BOSTON study and the
advancement of other ongoing selinexor clinical studies to their
next data inflection points.
Conference Call
Information:
Karyopharm will host a conference call today,
Thursday, March 16, 2017, at 8:30 a.m. Eastern Time, to discuss the
fourth quarter and full-year 2016 financial results, recent
accomplishments, clinical developments and business plans. To
access the conference call, please dial (855)
437-4406 (US) or (484) 756-4292 (international) at
least five minutes prior to the start time and refer to conference
ID: 79794446. An audio recording of the call will be available
under “Events & Presentations” in the “Investor” section
of Karyopharm's website, http://www.karyopharm.com, approximately
two hours after the event.
About Karyopharm
Therapeutics
Karyopharm Therapeutics Inc. (Nasdaq:KPTI) is a
clinical-stage pharmaceutical company focused on the discovery and
development of novel first-in-class drugs directed against nuclear
transport and related targets for the treatment of cancer and other
major diseases. Karyopharm's SINE™ compounds function by binding
with and inhibiting the nuclear export protein XPO1 (or CRM1). The
Company's initial focus is on seeking regulatory approval and
commercialization of its lead drug candidate, oral selinexor
(KPT-330). To date, over 1,900 patients have been treated with
selinexor and it is currently being evaluated in several mid- and
later-phase clinical trials across multiple cancer indications,
including multiple myeloma in combination with low-dose
dexamethasone (STORM) and backbone therapies (STOMP), diffuse large
B-cell lymphoma (SADAL), and liposarcoma (SEAL), among
others. Karyopharm plans to initiate a pivotal randomized
Phase 3 study of selinexor in combination with bortezomib
(Velcade®) and low-dose dexamethasone (BOSTON) in patients with
multiple myeloma in early 2017. In addition to single-agent
and combination activity against a variety of human cancers, SINE™
compounds have also shown biological activity in models of
neurodegeneration, inflammation, autoimmune disease, certain
viruses and wound-healing. Karyopharm, which was founded by Dr.
Sharon Shacham, currently has five investigational programs in
clinical or preclinical development. For more information, please
visit www.karyopharm.com.
Forward-Looking Statements
This press release contains forward-looking
statements within the meaning of The Private Securities Litigation
Reform Act of 1995. Such forward-looking statements include those
regarding the therapeutic potential of and potential clinical
development plans for Karyopharm's drug candidates, including the
timing of initiation of certain trials and of the reporting of data
from such trials, the anticipated impact of the partial clinical
hold, timing of FDA review of Karyopharm’s response and
Karyopharm’s plans for obtaining the release of the partial
clinical hold. 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 any of
Karyopharm's SINE™ compounds, including selinexor (KPT-330),
KPT-8602, Karyopharm's next generation SINE™ compound, or KPT-9274,
Karyopharm's first-in-class oral dual inhibitor of PAK4 and NAMPT,
or any other drug candidate that Karyopharm is developing will
successfully complete necessary preclinical and clinical
development phases, that development of any of Karyopharm's drug
candidates will continue or that the FDA will release the partial
clinical hold in a timely manner or at all. Further, there can be
no guarantee that any positive developments in Karyopharm's drug
candidate 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: Karyopharm's results of clinical trials and
preclinical studies, including subsequent analysis of existing data
and new data received from ongoing and future studies; the content
and timing of decisions made by the FDA and other regulatory
authorities, investigational review boards at clinical trial sites
and publication review bodies; Karyopharm's ability to obtain and
maintain requisite regulatory approvals and to enroll patients in
its clinical trials; unplanned cash requirements and expenditures;
development of drug candidates by Karyopharm's competitors for
diseases in which Karyopharm is currently developing its drug
candidates; and Karyopharm's ability to obtain, maintain and
enforce patent and other intellectual property protection for any
drug candidates it is developing. These and other risks are
described under the caption "Risk Factors" in Karyopharm's Annual
Report on Form 10-K for the year ended December 31 2016, which was
filed with the Securities and Exchange Commission (SEC) on March
16, 2017, and in other filings that Karyopharm may make with the
SEC in the future. Any forward-looking statements contained in this
press release speak only as of the date hereof, and Karyopharm
expressly disclaims any obligation to update any forward-looking
statements, whether as a result of new information, future events
or otherwise.
Velcade® is a registered trademark of Takeda
Pharmaceutical Company LimitedDarzalex® is a registered trademark
of Janssen Biotech, Inc.
Karyopharm
Therapeutics Inc.Consolidated Balance
Sheets(in thousands, except share and per share
amounts) |
|
|
|
|
|
December 31, 2016 |
|
December 31, 2015 |
ASSETS |
|
|
|
Current assets: |
|
|
|
Cash and
cash equivalents |
$ |
49,663 |
|
|
$ |
58,358 |
|
Short-term investments |
|
79,889 |
|
|
|
117,275 |
|
Prepaid
expenses and other current assets |
|
2,084 |
|
|
|
1,967 |
|
|
|
|
|
Total
current assets |
|
131,636 |
|
|
|
177,600 |
|
Property and equipment,
net |
|
2,836 |
|
|
|
3,483 |
|
Long-term
investments |
|
45,434 |
|
|
|
33,878 |
|
Restricted cash |
|
479 |
|
|
|
482 |
|
|
|
|
|
Total
assets |
$ |
180,385 |
|
|
$ |
215,443 |
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
Current
liabilities: |
|
|
|
Accounts
payable |
$ |
4,751 |
|
|
$ |
3,808 |
|
Accrued
expenses |
|
11,362 |
|
|
|
11,023 |
|
Deferred
rent |
|
280 |
|
|
|
206 |
|
Other
current liabilities |
|
83 |
|
|
|
95 |
|
|
|
|
|
Total
current liabilities |
|
16,476 |
|
|
|
15,132 |
|
Deferred rent, net of
current portion |
|
1,666 |
|
|
|
1,946 |
|
|
|
|
|
Total
liabilities |
|
18,142 |
|
|
|
17,078 |
|
|
|
|
|
|
|
|
|
Commitments and
contingencies |
|
|
|
|
|
|
|
Stockholders’
equity: |
|
|
|
Preferred
stock, $0.0001 par value; 5,000,000 shares authorized; none issued
and outstanding |
|
— |
|
|
|
— |
|
Common
stock, $0.0001 par value; 100,000,000 shares authorized; 41,887,829
and 35,864,765 shares issued and outstanding at December 31,
2016 and 2015, respectively |
|
4 |
|
|
|
4 |
|
Additional paid-in capital |
|
528,617 |
|
|
|
455,170 |
|
Accumulated other comprehensive loss |
|
(274 |
) |
|
|
(282 |
) |
Accumulated deficit |
|
(366,104 |
) |
|
|
(256,527 |
) |
|
|
|
|
Total
stockholders’ equity |
|
162,243 |
|
|
|
198,365 |
|
|
|
|
|
Total
liabilities and stockholders’ equity |
$ |
180,385 |
|
|
$ |
215,443 |
|
|
|
|
|
Karyopharm Therapeutics
Inc.CONSOLIDATED STATEMENTS OF
OPERATIONS (in thousands, except share and
per share amounts) |
|
|
|
|
|
|
|
|
|
(Unaudited)For the Quarter
Ended, December 31, |
|
For the Year Ended December 31, |
|
2016 |
|
2015 |
|
2016 |
|
2015 |
Contract and grant
revenue |
$ |
47 |
|
|
$ |
25 |
|
|
$ |
154 |
|
|
$ |
250 |
|
Operating
expenses: |
|
|
|
|
|
|
|
Research
and development |
|
20,671 |
|
|
|
24,064 |
|
|
|
86,938 |
|
|
|
97,744 |
|
General
and administrative |
|
6,541 |
|
|
|
5,264 |
|
|
|
23,948 |
|
|
|
21,582 |
|
|
|
|
|
|
|
|
|
Total
operating expenses |
|
27,212 |
|
|
|
29,328 |
|
|
|
110,886 |
|
|
|
119,326 |
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
(27,165 |
) |
|
|
(29,303 |
) |
|
|
(110,732 |
) |
|
|
(119,076 |
) |
Other income
(expense): |
|
|
|
|
|
|
|
Interest
income |
|
358 |
|
|
|
250 |
|
|
|
1,284 |
|
|
|
897 |
|
Other
income (expense) |
|
11 |
|
|
|
7 |
|
|
|
10 |
|
|
|
(2 |
) |
|
|
|
|
|
|
|
|
Total
other income, net |
|
369 |
|
|
|
257 |
|
|
|
1,294 |
|
|
|
895 |
|
|
|
|
|
|
|
|
|
Loss before income
taxes |
|
(26,796 |
) |
|
|
(29,046 |
) |
|
|
(109,438 |
) |
|
|
(118,181 |
) |
|
|
|
|
|
|
|
|
Provision for income
taxes |
|
(139 |
) |
|
|
— |
|
|
|
(139 |
) |
|
|
— |
|
|
|
|
|
|
|
|
|
Net loss |
$ |
(26,935 |
) |
|
$ |
(29,046 |
) |
|
$ |
(109,577 |
) |
|
$ |
(118,181 |
) |
|
|
|
|
|
|
|
|
Net loss per
share—basic and diluted |
$ |
(0.65 |
) |
|
$ |
(0.81 |
) |
|
$ |
(2.92 |
) |
|
$ |
(3.32 |
) |
|
|
|
|
|
|
|
|
Weighted-average number
of common shares outstanding used in net loss per share—basic and
diluted |
|
41,376,022 |
|
|
|
35,749,362 |
|
|
|
37,523,051 |
|
|
|
35,619,506 |
|
Contacts:
Justin Renz
(617) 658-0574
jrenz@karyopharm.com
Gina Nugent
(617) 460-3579
nugentcomm@aol.com
Media:
Eliza Schleifstein
(917) 763--8106
eliza@argotpartners.com
Karyopharm Therapeutics (NASDAQ:KPTI)
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