Constellation Pharmaceuticals Announces Fourth-Quarter and Full-Year 2018 Financial Results
14 Mars 2019 - 10:24PM
Constellation Pharmaceuticals, Inc. (Nasdaq: CNST), a
clinical-stage biopharmaceutical company using its expertise in
epigenetics to discover and develop novel therapeutics, today
announced its fourth-quarter and full-year 2018 financial results.
“2019 is a year of data for Constellation, and our clinical
programs are making significant progress and approaching important
readouts,” said Jigar Raythatha, president and chief executive
officer of Constellation Pharmaceuticals.
“We are excited by preliminary data from our first four patients
from the MANIFEST clinical trial, each showing one or more of the
following: conversion from transfusion dependence to transfusion
independence, hemoglobin increases, improvements in bone marrow
fibrosis scores, spleen reductions, and symptom improvements. These
results taken together suggest that CPI-0610 may have
disease-modifying effects in myelofibrosis patients. We plan to
present an interim update of data from MANIFEST from approximately
18-20 evaluable patients at a medical meeting in the second quarter
of 2019.
“We also plan to present Phase 1b data from the ProSTAR clinical
trial of CPI-1205 in metastatic castration-resistant prostate
cancer in a poster at the American Association for Cancer Research
annual meeting on April 1. Enrollment is on track in the Phase 2
portion of the ProSTAR trial, and we expect to provide an interim
update of data of the Phase 2 portion at a medical meeting in the
second half of 2019,” Mr. Raythatha continued.
“The Constellation team continues to work diligently toward
becoming a late-stage oncology development company and bringing
important new medicines to underserved cancer patients,” Mr.
Raythatha concluded.
Recent News
MANIFEST
- Enrollment is on track in the MANIFEST clinical trial in
myelofibrosis patients. The Company has now opened approximately 20
clinical trial sites in the U.S., Canada, and Europe. As of
February 28, 2019, 28 patients had been enrolled in the second-line
arms of MANIFEST. The Company plans to provide an update on
approximately 18-20 evaluable patients with at least three months
of data at a second quarter medical meeting.
- Each of the first four patients in MANIFEST remains on study.
As of the last data cutoff on December 10, 2018, the first two
patients treated with a combination of CPI-0610 and ruxolitinib had
been treated for over 16 months. The first two patients treated
with CPI-0610 monotherapy had been treated for over 12 months. As
previously reported, each of these four patients has shown a
reduction in spleen volume and improved hemoglobin levels. One of
the combination therapy patients was transfusion dependent before
therapy and converted to being transfusion independent after
CPI-0610 was added to the patient’s regimen. As of December 10,
2018, this patient had been free of transfusions for over 52 weeks.
Additionally, bone marrow biopsies before and after treatment were
analyzed for the first two evaluable patients on monotherapy, and
both demonstrated a one-grade improvement in bone marrow fibrosis
score as well as associated improvements in hemoglobin. Taken
together, these results suggest that CPI-0610 may be improving bone
marrow function in these ruxolitinib-resistant MF
patients.
- We believe CPI-0610 has the potential for a differentiated
toxicity profile compared with other BET inhibitors. In a Phase 1
clinical trial, the Company showed that the dose-limiting toxicity
for BET inhibitors of thrombocytopenia was reversible and
non-cumulative for CPI-0610. In addition, preliminary data suggest
that CPI-0610 may have a wider therapeutic window relative to some
other BET inhibitors, based on their published data. The
recommended Phase 2 dose of CPI-0610 in the MANIFEST study is 125
mg once daily, with titration allowed up to 225 mg once daily,
which is the maximum tolerated dose.
ProSTAR
- Constellation plans to provide an update of Phase 1b data for
ProSTAR in a poster at the Annual Meeting of the American
Association for Cancer Research in Atlanta on April 1.
- The Phase 2 portion of the ProSTAR clinical trial continues to
enroll patients in line with the Company’s plans. Constellation
plans to present an interim update of data of the Phase 2 portion
of ProSTAR at a medical meeting in the second half of 2019.
- Constellation recently began dosing in heavily pretreated
patients in a new arm of ProSTAR. Previously, a compassionate-use
patient, who had experienced disease progression despite treatment
with 12 agents (including abiraterone, enzalutamide, and
chemotherapy) prior to CPI-1205, experienced an 80% reduction in
PSA levels and evidence of tumor size reduction in the neck lymph
nodes when treated with CPI-1205 in combination with enzalutamide.
The new treatment arm will enroll up to 30 patients in a single arm
of CPI-1205 in combination with enzalutamide in heavily pretreated
patients.
Corporate
- On February 20, Constellation announced that Dr. Scott
Braunstein was appointed to the Board of Directors. Dr. Braunstein
is also a member of the Audit Committee. Dr Braunstein has an
impressive track record of helping emerging and established
biopharmaceutical companies as an investor and a pharmaceutical
executive.
- On March 1, Jessica Christo was appointed Chief Product
Development Officer. Ms. Christo brings to Constellation 25 years
of product development experience in the biopharmaceutical industry
in clinical operations, data management, program management,
biostatistics, and related fields.
Fourth Quarter 2018 Financial Results
- Cash and cash equivalents as of December 31, 2018
decreased 10.8% to $114.6 million compared to September
30, 2018, primarily due to operating expenses.
- Research and development (R&D) expenses increased 65.4%
year over year to $16.6 million in the fourth quarter of
2018 mainly due to increased clinical trial expenses.
- General and administrative (G&A) expenses grew 118.3% year
over year to $4.0 million in the fourth quarter of 2018,
primarily due to costs related to building out the organization as
the Company evolved from a preclinical-stage company to a
multi-candidate clinical-stage company, as well as costs associated
with operating as a public company.
- The net loss attributable to common stockholders increased
17.5% year over year to $19.9 million mainly due to increases
in G&A and R&D expenses, partly offset by the inclusion of
unpaid cumulative dividends in 2017 that were waived in 2018. The
net loss per share attributable to common stockholders decreased
95.6% to $0.77 per share for the fourth quarter of 2018
due to an increase in shares outstanding as a result of the initial
public offering and conversion of the preferred stock to common
stock.
Full-Year 2018 Financial Results
- Research and development (R&D) expenses increased 49.5%
year over year to $48.8 million in 2018 mainly due to
increased clinical trial expenses.
- General and administrative (G&A) expenses grew 92.8% year
over year to $12.5 million in 2018, primarily due to costs
related to building out the organization as the Company evolved
from a preclinical-stage company to a multi-candidate
clinical-stage company, as well as costs associated with operating
as a public company.
- The net loss attributable to common stockholders increased
11.5% year over year to $59.9 million mainly due to increases
in G&A and R&D expenses, partly offset by the inclusion of
unpaid cumulative dividends in 2017 that were waived in 2018. The
net loss per share attributable to common stockholders decreased
91.1% to $5.00 per share for 2018 due to an increase in
shares outstanding as a result of the initial public offering and
conversion of the preferred stock to common stock.
Financial Guidance
We expect that our cash and cash equivalents as of December
31, 2018, will fund operating expenses and capital expenditure
requirements into the second quarter of 2020.
Anticipated Milestones
The Company anticipates achieving the following milestones
during 2019:
First Half 2019
- Provide a data update from the Phase 1b portion of the ProSTAR
trial for CPI-1205 at the American Association for Cancer Research
meeting on April 1
- Provide an interim update of data from the MANIFEST Phase 2
trial of CPI-0610 at a second-quarter 2019 medical meeting
- Initiate a Phase 1 trial for CPI-0209
Second Half 2019
- Provide an interim update of data from the Phase 2 portion of
the ProSTAR trial for CPI-1205
- Provide an additional data update from the MANIFEST trial for
CPI-0610
Financial Results (Unaudited)
Constellation
Pharmaceuticals, Inc. |
|
|
|
|
|
|
|
|
Consolidated
Statements of Operations and Comprehensive Loss |
|
|
|
|
|
|
|
|
|
|
Years endedDecember 31, |
|
Three months endedDecember 31, |
(In thousands, except
share and per-share amounts) |
|
|
2018 |
|
|
|
2017 |
|
|
|
2018 |
|
|
|
2017 |
|
Revenue |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research and
development |
|
|
48,769 |
|
|
|
32,617 |
|
|
|
16,626 |
|
|
|
10,053 |
|
General and
administrative |
|
|
12,475 |
|
|
|
6,471 |
|
|
|
4,006 |
|
|
|
1,835 |
|
Total
operating expenses |
|
|
61,244 |
|
|
|
39,088 |
|
|
|
20,632 |
|
|
|
11,888 |
|
Loss from
operations |
|
|
(61,244 |
) |
|
|
(39,088 |
) |
|
|
(20,632 |
) |
|
|
(11,888 |
) |
Other income
(expense): |
|
|
|
|
|
|
|
|
Interest income |
|
|
1,547 |
|
|
|
169 |
|
|
|
688 |
|
|
|
58 |
|
Interest expense |
|
|
(228 |
) |
|
|
(901 |
) |
|
|
— |
|
|
|
(102 |
) |
Change in fair value of
preferred stock tranche liability |
|
|
— |
|
|
|
4,443 |
|
|
|
— |
|
|
|
— |
|
Total
other income (expense), net |
|
|
1,319 |
|
|
|
3,711 |
|
|
|
688 |
|
|
|
(44 |
) |
Net loss
and comprehensive loss |
|
|
(59,925 |
) |
|
|
(35,377 |
) |
|
|
(19,944 |
) |
|
|
(11,932 |
) |
Cumulative dividends on
convertible preferred stock |
|
|
— |
|
|
|
(18,390 |
) |
|
|
— |
|
|
|
(5,048 |
) |
Net loss
attributable to common stockholders |
|
|
(59,925 |
) |
|
|
(53,767 |
) |
|
|
(19,944 |
) |
|
|
(16,980 |
) |
Net loss per share
attributable to common stockholders, basic and diluted |
|
$ |
(5.00 |
) |
|
$ |
(56.10 |
) |
|
$ |
(0.77 |
) |
|
$ |
(17.64 |
) |
Weighted average common
shares outstanding, basic and diluted |
|
|
11,984,293 |
|
|
|
958,447 |
|
|
|
25,789,305 |
|
|
|
962,330 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Constellation
Pharmaceuticals, Inc. |
|
|
|
|
|
|
|
|
Consolidated
Balance Sheets |
|
|
|
|
|
|
|
|
(In $ thousands) |
|
December 31, 2018 |
|
December 31, 2017 |
|
|
|
|
Cash and cash
equivalents |
|
|
114,592 |
|
|
|
16,404 |
|
|
|
|
|
Other current
assets |
|
|
2,711 |
|
|
|
1,318 |
|
|
|
|
|
Total assets |
|
|
118,938 |
|
|
|
19,103 |
|
|
|
|
|
Current
liabilities |
|
|
14,660 |
|
|
|
11,131 |
|
|
|
|
|
Total liabilities |
|
|
14,780 |
|
|
|
11,708 |
|
|
|
|
|
Convertible preferred
stock |
|
|
— |
|
|
|
173,228 |
|
|
|
|
|
Total stockholders’
equity (deficit) |
|
|
104,158 |
|
|
|
(165,833 |
) |
|
|
|
|
Note: Abbreviated financial statements; please refer to Form
10-K for more details, including explanatory notes.
About Constellation Pharmaceuticals
Constellation Pharmaceuticals is a clinical-stage
biopharmaceutical company developing novel therapeutics that
selectively modulate gene expression to address serious unmet
medical needs in patients with cancer. The Company has a deep
understanding of how epigenetic and chromatin modifications in
cancer cells and in the tumor and immune microenvironment play a
fundamental role in driving disease progression and drug
resistance. Constellation is driving development of the EZH2
inhibitors CPI-1205 and CPI-0209 for the treatment of metastatic
castration-resistant prostate cancer and other cancers as well as
the BET inhibitor CPI-0610 for the treatment of myelofibrosis. The
Company is also applying its broad research and development
capabilities to explore other novel targets that directly and
indirectly impact gene expression to fuel a sustainable pipeline of
innovative small-molecule product candidates.
Forward-Looking Statements
This press release contains “forward-looking statements” within
the meaning of the Private Securities Litigation Reform Act of 1995
that involve substantial risks and uncertainties, including
statements regarding the implications of preliminary clinical data,
the development status of the Company’s product candidates, the
Company’s plans for future data presentations, its anticipated
achievement of milestones, including determination of proof of
concept and its financial guidance regarding the period in which it
will have capital available to fund its operations. All
statements, other than statements of historical facts, contained in
this press release, including statements regarding the Company’s
strategy, future operations, future financial position, prospects,
plans and objectives of management, are forward-looking statements.
The words “anticipate,” “believe,” “continue,” “could,” “estimate,”
“expect,” “intend,” “may,” “plan,” “potential,” “predict,”
“project,” “should,” “target,” “will,” “would” and similar
expressions are intended to identify forward-looking statements,
although not all forward-looking statements contain these
identifying words. Any forward-looking statements are based on
management’s current expectations of future events and are subject
to a number of risks and uncertainties that could cause actual
results to differ materially and adversely from those set forth in,
or implied by, such forward-looking statements. These risks and
uncertainties include, but are not limited to, risks associated
with Constellation’s ability to: obtain and maintain necessary
approvals from the FDA and other regulatory authorities; continue
to advance its product candidates in clinical trials; whether
preliminary or interim results from a clinical trial will be
predictive of the final results of the trial; replicate in later
clinical trials positive results found in preclinical studies and
early-stage clinical trials of CPI-1205, CPI-0610 and its other
product candidates; advance the development of its product
candidates under the timelines it anticipates, or at all, in
current and future clinical trials; obtain, maintain or protect
intellectual property rights related to its product candidates;
manage expenses; and raise the substantial additional capital
needed to achieve its business objectives. For a discussion of
other risks and uncertainties, any of which could cause the
Company’s actual results to differ from those contained in the
forward-looking statements, see the “Risk Factors” section, as well
as discussions of potential risks, uncertainties, and other
important factors, in the Company’s most recent filings with the
Securities and Exchange Commission. In addition, the forward-
looking statements included in this press release represent the
Company’s views as of the date hereof and should not be relied upon
as representing the Company’s views as of any date subsequent to
the date hereof. The Company anticipates that subsequent events and
developments will cause the Company’s views to change. However,
while the Company may elect to update these forward-looking
statements at some point in the future, the Company specifically
disclaims any obligation to do so. CPI-1205, CPI-0610, CPI-0209,
and other product candidates are investigational in nature and have
not yet been approved by the FDA or other regulatory
authorities.
Contact
Ronald Aldridge Senior Director, Investor RelationsConstellation
Pharmaceuticals+1
617-714-0539ron.aldridge@constellationpharma.com
Lauren ArnoldMedia RelationsMacDougall Biomedical
Communications+1 781-235-3060larnold@macbiocom.com
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