Constellation Pharmaceuticals Announces Second-Quarter and Six-Month 2019 Financial Results
07 Août 2019 - 10:05PM
Constellation Pharmaceuticals, Inc., a clinical-stage
biopharmaceutical company using its expertise in epigenetics to
discover and develop novel therapeutics, today announced its
second-quarter and six-month 2019 financial results.
“2019 is a year of data for Constellation,” said Jigar
Raythatha, president and chief executive officer of Constellation
Pharmaceuticals. “We made multiple important data presentations in
the second quarter that help to advance our vision of becoming a
late-stage oncology development company, with an exciting pipeline
of development and discovery programs.
“We look forward to providing further data updates in the second
half of 2019 across our pipeline,” Mr. Raythatha continued. “We
remain deeply committed to delivering important new medicines to
cancer patients around the world in order to reduce their suffering
and improve their lives.”
Program Updates
CPI-0610
- Data presented at ASCO and EHA from the MANIFEST study suggest
that CPI-0610 may have disease-modifying effects.
- In addition to improvements in spleen volume and constitutional
symptoms, the interim data suggest improvements in anemia,
transfusion dependence, and bone marrow fibrosis.
- Our vision for CPI-0610 is to create a differentiated treatment
for MF in ruxolitinib-resistant patients and to transform standard
of care as a first-line therapy. We have begun planning for pivotal
trials.
EZH2 Franchise
- Enrollment for the ProSTAR clinical trial for CPI-1205
continues on track.
- We are enrolling patients in three cohorts:-- CPI-1205 +
abiraterone in second-line mCRPC;-- CPI-1205 +
enzalutamide in second-line mCRPC, randomized against enzalutamide
alone; and-- CPI-1205 + enzalutamide in heavily
pre-treated patients who have progressed after treatment with each
of enzalutamide, abiraterone, and chemotherapy.
- We plan to provide an update for ProSTAR in the fourth quarter
and additional data in early 2020.
- The IND for CPI-0209, our second-generation and potentially
best-in-class EZH2 inhibitor, was filed and cleared by the
FDA.
- CPI-0209 could address additional patient populations beyond
those targeted by first-generation EZH2 inhibitors.
Milestones
The Company anticipates achieving the following milestones
during the second half of 2019:
CPI-0610 MANIFEST Study
- Update spleen volume, symptom, and anemia data from about 40
ruxolitinib-resistant patients and bone-marrow-fibrosis changes
from a subset of patients.
- Update status of conversion from transfusion dependence to
transfusion independence from about 16 ruxolitinib-resistant
patients.
- Disclose spleen volume and symptom data for 10-15
JAK-inhibitor-naïve (first-line) patients.
EZH2 Franchise
- Dose the first patients in a Phase 1 clinical trial of
CPI-0209.
- Provide an update from the ProSTAR clinical trial of CPI-1205
across various patient contexts.
Second Quarter 2019 Financial Results
- Cash, cash equivalents, and marketable securities as
of June 30, 2019, were $98.1 million, a decline of
14.4% compared to December 31, 2018, primarily due to
operating expenses.
- Research and development (R&D) expenses increased 67.3%
year over year to $16.0 million in the second quarter of
2019 mainly due to increased clinical trial expenses.
- General and administrative (G&A) expenses grew 96.5% year
over year to $4.9 million in the second quarter of 2019,
primarily due to building out the organization of the company.
- The net loss increased 73.9% year over year to $20.8
million for the second quarter of 2019, mainly due to increased
R&D and G&A expenses. The net loss per share attributable
to common shareholders decreased 92.0% to $0.80 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.
First Half 2019 Financial Results
- Research and development (R&D) expenses increased 63.0%
year over year to $31.6 million in the first half of
2019, mainly due to increased clinical trial expenses.
- General and administrative (G&A) expenses grew 94.5% year
over year to $9.3 million in the first half of 2019, primarily
due to building out the organization of the company.
- The net loss increased 67.2% year over year to $40.2
million for the first half of 2019, mainly due to increased R&D
and G&A expenses. The net loss per share attributable to common
shareholders decreased 92.9% to $1.56 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 cash, cash equivalents, and
marketable securities as of June 30, 2019, will enable the Company
to fund planned operating expenses and capital expenditure
requirements until late third-quarter 2020.
Constellation Pharmaceuticals,
Inc. |
Consolidated Statements of Operations
and Comprehensive Loss |
|
|
|
Six months ended June 30, |
|
Three months ended June 30, |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(In thousands, except share and per-share amounts) |
|
|
2019 |
|
|
|
2018 |
|
|
|
2019 |
|
|
|
2018 |
|
Revenue |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
31,632 |
|
|
|
19,410 |
|
|
|
15,955 |
|
|
|
9,536 |
|
General and administrative |
|
|
9,315 |
|
|
|
4,789 |
|
|
|
4,886 |
|
|
|
2,486 |
|
Total operating expenses |
|
|
40,947 |
|
|
|
24,199 |
|
|
|
20,841 |
|
|
|
12,022 |
|
Loss from operations |
|
|
(40,947 |
) |
|
|
(24,199 |
) |
|
|
(20,841 |
) |
|
|
(12,022 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
1,407 |
|
|
|
377 |
|
|
|
652 |
|
|
|
268 |
|
Interest expense |
|
|
(653 |
) |
|
|
(221 |
) |
|
|
(578 |
) |
|
|
(187 |
) |
Total other income (expense), net |
|
|
754 |
|
|
|
156 |
|
|
|
74 |
|
|
|
81 |
|
Net loss attributable to common
stockholders |
|
|
(40,193 |
) |
|
|
(24,043 |
) |
|
|
(20,767 |
) |
|
|
(11,941 |
) |
Other comprehensive gain |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain on marketable securities |
|
|
11 |
|
|
|
— |
|
|
|
2 |
|
|
|
— |
|
Total other comprehensive gain |
|
|
11 |
|
|
|
— |
|
|
|
2 |
|
|
|
— |
|
Comprehensive loss |
|
|
(40,182 |
) |
|
|
(24,043 |
) |
|
|
(20,765 |
) |
|
|
(11,941 |
) |
Net loss per share attributable
to common stockholders, basic and diluted |
|
$ |
(1.56 |
) |
|
$ |
(22.12 |
) |
|
$ |
(0.80 |
) |
|
$ |
(9.96 |
) |
Weighted average common shares
outstanding, basic and diluted |
|
|
25,807,132 |
|
|
|
1,086,697 |
|
|
|
25,809,556 |
|
|
|
1,199,164 |
|
Constellation Pharmaceuticals,
Inc. |
Consolidated Balance Sheets |
|
(In $ thousands) |
|
June 30, 2019 |
|
December 31, 2018 |
Cash and cash equivalents |
|
$ |
55,043 |
|
$ |
114,592 |
Marketable securities |
|
|
43,057 |
|
|
— |
Total current assets |
|
|
100,666 |
|
|
117,303 |
Total assets |
|
|
114,253 |
|
|
118,938 |
Current liabilities |
|
|
17,201 |
|
|
14,660 |
Long-term debt, net of current
portion and discount |
|
|
19,568 |
|
|
— |
Total liabilities |
|
|
47,069 |
|
|
14,780 |
Total stockholders’
equity |
|
$ |
67,184 |
|
$ |
104,158 |
|
|
|
|
|
|
|
About Constellation Pharmaceuticals
Constellation Pharmaceuticals is a clinical-stage
biopharmaceutical company using its expertise in epigenetics to
discover and develop novel therapeutics that address serious unmet
medical needs in patients with cancers associated with abnormal
gene expression or drug resistance. Constellation’s integrated
epigenetics platform enables the Company to validate targets and
generate small molecules against these targets that selectively
modulate gene expression in tumor and immune cells to drive
anti-tumor activity. Platform insights and clinical experience
guide development of wholly owned lead product candidates:
CPI-0610, which inhibits bromodomain and extra-terminal domain, or
BET, proteins, and CPI-1205, which inhibits enhancer of zeste
homolog 2, or EZH2, proteins. The Company believes that its
approach to targeting these central gene regulatory mechanisms
associated with cancer proliferation may enable it to provide
therapeutic benefits to cancer patients.
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 or interim
clinical data, the development status of the Company’s product
candidates, and the Company’s plans for future data presentations.
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;
determine 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-0610, CPI-1205, 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-0610, CPI-1205, CPI-0209,
and other product candidates are investigational in nature and have
not yet been approved by the FDA or other regulatory
authorities.
Contacts
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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