Constellation Pharmaceuticals, Inc. (Nasdaq: CNST), a
clinical-stage biopharmaceutical company using its expertise in
epigenetics to discover and develop novel therapeutics, announced
its first-quarter 2019 financial results today.
“2019 is a year of data for Constellation,” said
Jigar Raythatha, President and Chief Executive Officer of
Constellation Pharmaceuticals. “We look forward to an exciting year
ahead, as we continue to see strong enrollment trends and expect
multiple clinical readouts throughout the year for both CPI-0610 in
myelofibrosis (MF) and CPI-1205 in prostate cancer.
“We look forward to presenting an interim update
of data from the Phase 2 MANIFEST clinical trial for CPI-0610 in a
poster presentation at ASCO and an oral presentation at EHA in
June,” Mr. Raythatha continued. “We believe these data will support
the view that CPI-0610 has the potential to be a disease-modifying
agent in MF. Additionally, we expect to provide further data
readouts on both CPI-0610 and CPI-1205 in the second half of
2019.
“Our vision is to become a late-stage oncology
development company in 2020, with an exciting pipeline of
development and discovery programs that have the potential to bring
important new medicines to underserved cancer patients,” Mr.
Raythatha concluded.
Medical Presentations
Constellation plans to present a poster
providing an interim update of data from the MANIFEST clinical
trial of CPI-0610 at the American Society for Clinical Oncology
(ASCO) annual meeting at 9:00 AM EDT/8:00 CDT on June 3. In
addition, Dr. Ronald Hoffman of Mt. Sinai Health System, an
investigator in the MANIFEST trial, will make an oral presentation
providing an interim update of data at the European Hematology
Association (EHA) annual meeting at 12:15 PM CEST/6:15 AM EDT on
June 15. Data to be presented at these events were generated from
44 patients enrolled as of April 17, 2019. Twelve patients received
24-week assessments and 16 patients received 12-week assessments.
The Company plans to report data for these patients based on the
following parameters: spleen volume reduction; total symptom score
improvement; hematologic parameters such as
increased hemoglobin and conversion to transfusion
independence; bone marrow fibrosis improvement; and safety.
Investor Event
The Company will also host an analyst/investor
meeting, with an accompanying conference call and webcast, to
discuss the interim update of data at Hyatt McCormick Place in
Chicago at 8:00 AM EDT/7:00 AM CDT on June 4. The agenda of the
meeting will include an overview of MF, the potential impact of
CPI-0610 on MF, review of the interim update of data from MANIFEST,
and a panel discussion with Dr. Srdan Verstovsek of MD Anderson
Cancer Center, an investigator in the MANIFEST trial, and Dr.
Raajit Rampal of Memorial Sloan Kettering Cancer Center. Additional
details about this event will be announced at a later date.
Recent News
- Provided data update of MANIFEST clinical trial at J.P.
Morgan Healthcare Conference. In a press release on
January 3 and a presentation at the J.P. Morgan Healthcare
Conference on January 9, Constellation provided an interim update
of data on the Phase 2 MANIFEST clinical trial of CPI-0610. As
disclosed in that presentation, each of the first four
ruxolitinib-resistant MF patients in MANIFEST remained on study as
of December 10, 2018. Two patients were treated with a combination
of CPI-0610 and ruxolitinib for over 16 months, and two patients
were treated with CPI-0610 monotherapy for over 12 months. Each of
these four patients showed a reduction in spleen volume, symptom
improvement, and an increased hemoglobin level. One of the
combination therapy patients, who was transfusion dependent before
therapy, converted to being transfusion independent after CPI-0610
was added to the ongoing regimen. Additionally, bone marrow
biopsies before and after treatment were analyzed for the two
patients on monotherapy, and both demonstrated a one-grade
improvement in bone marrow fibrosis score and associated
improvements in hemoglobin and platelets. Taken together, these
results suggest that CPI-0610 may be modifying the underlying
course of the disease in these ruxolitinib-resistant MF
patients.
- Presented ProSTAR results at AACR. On April 1,
Constellation presented results from the Phase 1b portion of the
ProSTAR clinical trial of CPI-1205 at the American Association
for Cancer Research annual meeting. These
results showed clinical activity in subsets of a heterogeneous
population of advanced mCRPC patients in combination with either
abiraterone or enzalutamide. All PSA responses seen in
the trial were ≥80%, deeper than the ≥50% reduction endpoint in the
trial. The majority of patients with measurable lesions achieved
durable disease control during the study. For more details, please
review the poster on our website here.The Company initiated the
Phase 2 portion of the trial in late 2018 to better define the
patient populations most likely to benefit from CPI-1205. The
Company looks forward to reporting initial Phase 2 data in the
second half of 2019.
- Expanded Board of Directors. In February,
Constellation announced the appointment of Dr. Scott
Braunstein to its Board of Directors. Dr. Braunstein brings a track
record of growing emerging and established biopharmaceutical
companies as a board member, pharmaceutical executive, and
investor.
- Enhanced Management Team. Also in February,
Constellation announced the appointment of Jessica Christo as
Senior Vice President and Chief Product Development Officer. Ms.
Christo has 25 years of product development experience in the
biopharmaceutical industry. Most recently, she was Senior Vice
President of Development Operations at Verastem Oncology, where she
had broad clinical and regulatory responsibilities and contributed
to the approval of COPIKTRATM.
First Quarter 2019 Financial
Results
- Cash, cash equivalents, and marketable securities as of March
31, 2019, increased 1.0% compared to December 31, 2018, to $115.8
million due to proceeds from a $20 million term loan led by
Hercules Capital, which approximately offset operating expenses in
the quarter.
- Research and development (R&D) expenses increased 58.8%
year over year to $15.7 million in the first quarter of
2019 mainly due to increased clinical trial expenses.
- General and administrative (G&A) expenses grew 92.3% year
over year to $4.4 million in the first quarter of 2019,
primarily due to personnel-related and facility-related costs in
connection with expanding the support functions of 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
60.5% year over year to $19.4 million mainly due to increases
in G&A and R&D expenses. The net loss per share
attributable to common stockholders decreased 94.0%
to $0.75 per share for the first quarter of 2019 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 The Company
expects that cash, cash equivalents, and marketable securities as
of March 31, 2019, will fund operating expenses and
capital expenditure requirements into the third quarter of
2020.
Anticipated Milestones
The Company anticipates achieving the following
milestones during 2019:
First Half 2019
- Provide an interim update of data from the MANIFEST Phase 2
trial of CPI-0610 at ASCO and EHA
- Complete an investigational new drug (IND) filing 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 |
|
|
|
|
Three months ended March 31, |
(In thousands, except share and per-share amounts) |
|
2019 |
|
|
|
2018 |
|
Revenue |
$ |
— |
|
|
$ |
— |
|
Operating expenses: |
|
|
|
Research and development |
|
15,677 |
|
|
|
9,874 |
|
General and administrative |
|
4,429 |
|
|
|
2,303 |
|
Total operating expenses |
|
20,106 |
|
|
|
12,177 |
|
Loss from operations |
|
(20,106 |
) |
|
|
(12,177 |
) |
Other income (expense): |
|
|
|
Interest income |
|
755 |
|
|
|
109 |
|
Interest expense |
|
(75 |
) |
|
|
(34 |
) |
Total other income (expense), net |
|
680 |
|
|
|
75 |
|
Net loss attributable to common
stockholders |
|
(19,426 |
) |
|
|
(12,102 |
) |
Other comprehensive gain: |
|
|
|
Unrealized gain on marketable securities |
|
9 |
|
|
|
— |
|
Other comprehensive gain |
|
9 |
|
|
|
— |
|
Comprehensive loss |
|
(19,417 |
) |
|
|
(12,102 |
) |
Net loss per share attributable
to common stockholders, basic and diluted |
$ |
(0.75 |
) |
|
$ |
(12.44 |
) |
Weighted average common shares
outstanding, basic and diluted |
|
25,804,595 |
|
|
|
972,981 |
|
|
|
|
|
|
|
|
|
Constellation Pharmaceuticals,
Inc. |
|
|
|
Consolidated Balance Sheets |
|
|
|
(In $ thousands) |
March 31, 2019 |
|
December 31, 2018 |
Cash and cash equivalents |
$ |
52,447 |
|
|
$ |
114,592 |
|
Marketable securities |
|
63,344 |
|
|
|
— |
|
Other current assets |
|
2,695 |
|
|
|
2,711 |
|
Total assets |
|
124,923 |
|
|
|
118,938 |
|
Current liabilities |
|
17,121 |
|
|
|
14,660 |
|
Total liabilities |
|
38,848 |
|
|
|
14,780 |
|
Total stockholders’
equity |
$ |
86,075 |
|
|
$ |
104,158 |
|
Note: Abbreviated financial statements; please
refer to Form 10-Q for the first quarter of 2019 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, 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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