Constellation Pharmaceuticals Announces Third-Quarter and Nine-Month 2019 Financial Results
06 Novembre 2019 - 3:00PM
Constellation Pharmaceuticals, Inc., a clinical-stage
biopharmaceutical company using its expertise in epigenetics to
discover and develop novel therapeutics, today announced its
third-quarter and nine-month 2019 financial results.
“Our clinical programs continued to advance during the third
quarter,” said Jigar Raythatha, president and chief executive
officer of Constellation Pharmaceuticals. “We are particularly
pleased with new MANIFEST data on CPI-0610 in myelofibrosis
published today in abstracts by the American Society of Hematology
(ASH). The data in the abstracts show signs of encouraging clinical
activity in both JAK-inhibitor-naïve patients and
ruxolitinib-refractory or -intolerant patients. Based on this
activity, we have expanded the MANIFEST trial in first-line
patients and in second-line transfusion-dependent patients to look
more closely at these signals of activity. We plan to provide a
further update on CPI-0610 in oral and poster presentations and at
an investor event at the ASH meeting on December 9. Additionally,
we have begun planning for a randomized Phase 3 clinical trial for
CPI-0610 in JAK-inhibitor-naïve patients that we expect to begin in
2020.”
Program Updates
CPI-0610
Two abstracts with preliminary data from the MANIFEST clinical
trial from 59 enrolled patients as of June 27, 2019, the data
cutoff date, were published today in association with ASH. The
following are highlights from the abstracts:
- In Arm 3, in which we are evaluating CPI-0610 in combination
with ruxolitinib in a first-line setting in JAK-inhibitor-naïve
patients, all four evaluable patients experienced at least a 35%
spleen volume reduction and at least a 50% reduction in total
symptom score, which are the primary endpoints for these
patients.
- In Arms 1 and 2, in which we are evaluating CPI-0610 in
combination with ruxolitinib and as a monotherapy in a second-line
setting in ruxolitinib-resistant or -intolerant patients,
additional preliminary data showed continuing signs of activity
across a broad range of parameters, including spleen volume
reduction, patient-reported symptom improvement, hemoglobin
increases, conversion to transfusion independence in
transfusion-dependent patients, and bone marrow fibrosis score
improvement, consistent with preliminary data presented at ASCO and
EHA in June.
- In Arms 1 and 2, conversions to transfusion independence
increased from two as of April 17, 2019, to four as of June 27,
2019. Data from 12 additional patients are being monitored for
possible additional conversions.
- CPI-0610 was generally well-tolerated, both as a monotherapy or
in combination with ruxolitinib. One ruxolitinib-resistant or
-intolerant patient discontinued due to serious adverse event(s),
which were reported as unlikely related to CPI-0610. No
JAK-inhibitor-naïve patients discontinued due to adverse events.
Please review the abstracts here for more details.
- The Company will present updates of clinical data from MANIFEST
in oral and poster presentations at the ASH annual meeting on
December 9 and will also host an investor meeting. Please read here
for additional information.
- We expanded Arm 3 of MANIFEST for JAK-inhibitor-naïve patients
from 43 to up to approximately 100 patients. We expanded Cohort 2A
for TD ruxolitinib-refractory or -intolerant patients being treated
with CPI-0610 + ruxolitinib, and we may expand Cohort 1A for TD
ruxolitinib-refractory or -intolerant patients being treated with
CPI-0610 monotherapy, from 16 to up to approximately 60 patients in
each cohort.
- We have started planning for a potential pivotal trial with
CPI-0610 for MF in the first-line setting, and we expect the trial
to begin in 2020.
CPI-1205
Constellation provided a program update on CPI-1205:
- Enrollment in the Phase 2 portion of ProSTAR is nearly
complete.
- An endpoint accepted by regulatory authorities for pivotal
clinical trials in prostate cancer is radiographic progression-free
survival (rPFS). In addition, we learned from a study presented by
the Kim Chi lab at the 2018 American Society of Clinical Oncology
annual meeting that median responses to second-line therapy
generally last only a few months.
- Data from the Phase 1b portion of ProSTAR provided preliminary
evidence of deep and durable effects of CPI-1205 in certain
metastatic castration-resistant prostate cancer patients. We are
shifting our focus in this study to durability of clinical activity
with CPI-1205.
- We are gathering data on time to progression (TTP) of CPI-1205
in ProSTAR, a metric that may serve as a surrogate for rPFS
and may guide future development of the compound.
Determining TTP will require additional time for the data set to
mature, and we expect to report these data from ProSTAR in
mid-2020. Plans for any potential Phase 3 program for CPI-1205 will
depend on our assessment of the Phase 2 data.
CPI-0209
- Enrollment of patients in a Phase 1/2 clinical trial of
CPI-0209 continues according to plan. Dosing began in September
2019.
- CPI-0209 is a second-generation and potentially best-in-class
EZH2 inhibitor that has been designed to achieve comprehensive
target coverage through extended on-target residence time. The
compound has demonstrated more robust anti-tumor activity compared
to first-generation EZH2 inhibitors in preclinical models of
multiple cancer types. We believe that CPI-0209 may enable us to
address additional patient populations beyond those that we are
targeting with CPI-1205 or that have been targeted by other EZH2
inhibitors.
Third Quarter 2019 Financial Results
- Cash, cash equivalents, and marketable securities as
of September 30, 2019, were $89.1 million, a decline of
22.3% compared to December 31, 2018, primarily due to
operating expenses. On October 3, 2019, the Company raised
gross proceeds of $65 million in a private placement of its
stock.
- Research and development (R&D) expenses increased 27.6%
year over year to $16.2 million in the third quarter of
2019 mainly due to increased clinical trial expenses.
- General and administrative (G&A) expenses grew 30.7% year
over year to $4.8 million in the third quarter of 2019,
primarily due to building out the organization of the company.
- The net loss increased 32.7% year over year to $21.1
million for the third quarter of 2019, mainly due to increased
R&D and G&A expenses. The net loss per share attributable
to common shareholders increased 1.2% to $0.82 per share due to the
increased net loss, offset in part by an increase in shares
outstanding as a result of the initial public offering in 2018 and
conversion of preferred stock to common stock.
Nine Month 2019 Financial Results
- Research and development (R&D) expenses increased 48.9%
year over year to $47.9 million in the first nine months
of 2019, mainly due to increased clinical trial expenses.
- General and administrative (G&A) expenses grew 66.8% year
over year to $14.1 million in the first nine months of 2019,
primarily due to building out the organization of the company.
- The net loss increased 53.4% year over year to $61.3
million for the first nine months of 2019, mainly due to increased
R&D and G&A expenses. The net loss per share attributable
to common shareholders decreased 56.3% to $2.38 per share due
to an increase in shares outstanding as a result of the initial
public offering in 2018 and conversion of preferred stock to common
stock.
Financial Guidance Constellation expects
that its cash, cash equivalents, and marketable securities as of
September 30, 2019, plus the $65 million of proceeds from a private
placement completed on October 3, 2019, will enable the Company to
fund planned operating expenses and capital expenditure
requirements into the first half of 2021.
Results of Operations
Constellation Pharmaceuticals, Inc. |
|
|
|
|
|
|
|
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Consolidated Statements of Operations and Comprehensive
Loss |
|
|
|
|
|
|
|
|
|
|
Nine months ended September 30, |
|
Three months ended September 30, |
(In thousands, except share
and per-share amounts) |
|
|
2019 |
|
|
|
2018 |
|
|
|
2019 |
|
|
|
2018 |
|
Revenue |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
47,873 |
|
|
|
32,143 |
|
|
|
16,241 |
|
|
|
12,733 |
|
General and administrative |
|
|
14,125 |
|
|
|
8,469 |
|
|
|
4,810 |
|
|
|
3,680 |
|
Total operating expenses |
|
|
61,998 |
|
|
|
40,612 |
|
|
|
21,051 |
|
|
|
16,413 |
|
Loss from operations |
|
|
(61,998 |
) |
|
|
(40,612 |
) |
|
|
(21,051 |
) |
|
|
(16,413 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
Interest income |
|
|
1,914 |
|
|
|
859 |
|
|
|
507 |
|
|
|
482 |
|
Interest expense |
|
|
(1,258 |
) |
|
|
(228 |
) |
|
|
(605 |
) |
|
|
(7 |
) |
Total other income (expense), net |
|
|
656 |
|
|
|
631 |
|
|
|
(98 |
) |
|
|
475 |
|
Net loss attributable to common
stockholders |
|
|
(61,342 |
) |
|
|
(39,981 |
) |
|
|
(21,149 |
) |
|
|
(15,938 |
) |
Other comprehensive gain
(loss) |
|
|
|
|
|
|
|
|
Unrealized gain (loss) on marketable securities |
|
|
1 |
|
|
|
— |
|
|
|
(10 |
) |
|
|
— |
|
Total other comprehensive gain (loss) |
|
|
1 |
|
|
|
— |
|
|
|
(10 |
) |
|
|
— |
|
Comprehensive loss |
|
|
(61,341 |
) |
|
|
(39,981 |
) |
|
|
(21,159 |
) |
|
|
(15,938 |
) |
Net loss per share attributable
to common stockholders, basic and diluted |
|
$ |
(2.38 |
) |
|
$ |
(5.45 |
) |
|
$ |
(0.82 |
) |
|
$ |
(0.81 |
) |
Weighted average common shares
outstanding, basic and diluted |
|
|
25,814,593 |
|
|
|
7,332,052 |
|
|
|
25,829,105 |
|
|
|
19,619,239 |
|
|
|
|
|
|
Constellation Pharmaceuticals, Inc. |
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Consolidated Balance Sheets |
|
|
|
|
(In $ thousands) |
|
September 30, 2019 |
|
December 31, 2018 |
Cash and cash equivalents |
|
$ |
78,977 |
|
$ |
114,592 |
Marketable securities |
|
|
10,089 |
|
|
— |
Total current assets |
|
|
92,210 |
|
|
117,303 |
Total assets |
|
|
105,217 |
|
|
118,938 |
Current liabilities |
|
|
17,754 |
|
|
14,660 |
Long-term debt, net of current
portion and discount |
|
|
29,603 |
|
|
— |
Total liabilities |
|
|
57,065 |
|
|
14,780 |
Total stockholders’
equity |
|
$ |
48,152 |
|
$ |
104,158 |
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 BET
inhibitor CPI-0610 for the treatment of myelofibrosis as well as
the EZH2 inhibitors CPI-1205 and CPI-0209 for the treatment of
metastatic castration-resistant prostate cancer and other cancers.
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. Such forward-looking statements include, but are not limited
to, the Company’s plans, strategies and prospects for its business.
All statements, other than statements of historical facts,
contained in this press release, including statements regarding the
implications of preliminary or interim clinical data, the
development status of the Company’s product candidates, and the
Company’s plans for future data presentations, 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 the Company’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 data 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 CPI-0209;
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. CPI-0610, CPI-1205 and CPI-0209 are investigational
therapies and have not been approved by the FDA (or any other
regulatory authority). 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, including the Company’s Quarterly Report on Form 10-Q
for the quarter ended September 30, 2019. 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.
ContactsRonald 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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