Constellation Pharmaceuticals, Inc., a clinical-stage
biopharmaceutical company using its expertise in epigenetics to
discover and develop novel therapeutics, today announced its
first-quarter 2020 financial results.
“In the face of the serious public health and economic impacts
of the COVID-19 pandemic, we at Constellation remain focused on our
mission of addressing unmet medical needs in cancer and
hematological diseases,” said Jigar Raythatha, president and chief
executive officer of Constellation Pharmaceuticals. “We are
continuing to make progress on each of our development programs and
are steadily advancing toward our goal of becoming a fully
integrated hematology / oncology company with a sustainable product
pipeline.
“Our vision is to transform the standard of care in
myelofibrosis with CPI-0610. Encouraging preliminary data on
CPI-0610 suggest possible disease-modifying effects, including
improvement in bone marrow fibrosis, hemoglobin increases, and
conversion of transfusion dependence to transfusion independence,
as well as spleen volume reductions and symptom improvement – both
in combination with ruxolitinib and as a monotherapy.
“We are also working to create novel treatments for patients in
other therapeutic areas,” Mr. Raythatha concluded. “We believe that
our EZH2-inhibitor franchise of CPI-1205 and CPI-0209 provides
potential opportunities to treat a wide range of oncology patients,
and we aim to achieve important milestones with each of these
molecules this year.”
Program Updates
CPI-0610
- On May 14, we expect three abstracts to publish in association
with the European Hematology Association. We will provide an update
with 12-week data from 29 JAK-inhibitor-naïve (first-line)
patients, 24-week data from 15 JAK-inhibitor-naïve patients, and
24-week data from 48 JAK-inhibitor-experienced (second-line)
patients.
- Data will include preliminary evidence of disease modification,
including bone marrow fibrosis, hemoglobin changes, and conversion
from transfusion dependence to transfusion independence, in
addition to spleen and symptom improvement.
- In mid-June, we expect to present a further update in
conjunction with the EHA meeting, including 12-week data from
approximately 50 first-line patients, and 24-week data from 25-30
first-line patients and 70-80 second-line patients.
- We aim to start a global clinical trial for CPI-0610 in the
first-line setting during the second half of 2020.
- We continue to plan to meet with the FDA in mid-2020 to discuss
the future development of CPI-0610.
EZH2
- The ProSTAR trial is fully enrolled and we plan to determine
next steps for CPI-1205 after taking a mid-year data cut. As we
previously discussed, our plans for any potential Phase 3 program
for CPI-1205 will depend on our assessment of these data
on duration of effect, as well as other considerations.
- The Phase 1 clinical trial for CPI-0209 is proceeding as
planned, and we expect to determine a recommended Phase 2 dose in
the second half of 2020. Once we have established the Phase 2 dose
we plan to start a broad-based expansion study in solid
tumors.
Impact of COVID-19
- Execution of ongoing clinical trials. Patient safety remains
paramount in the execution of our clinical trials. In the face of
the COVID-19 pandemic, we continue to treat patients in our
MANIFEST, ProSTAR, and CPI-0209 clinical trials.Patient enrollment
in MANIFEST began to slow toward the end of first quarter of 2020.
Prior to the pandemic, we had met or exceeded our internal
enrollment goal for MANIFEST, and we continue to assess what impact
the pandemic could have on our MANIFEST trial timeline. Similarly,
while we have had incidences of incomplete data collection to date,
we are utilizing provisions of the protocol and recent regulatory
guidance that provide potential flexibility in the time and place
of data collection, and we will continue to monitor the situation.
We expect to provide a data update at EHA similar to our plans
prior to the COVID-19 outbreak.To date, we have not seen a
significant impact of COVID-19 on clinical trials for CPI-1205
or CPI-0209. The ProSTAR trial for CPI-1205 is proceeding, and
we continue to expect to do a data cut in mid-2020 and to
provide an update shortly thereafter. Our CPI-0209 Phase 1
trial continues as planned before the COVID-19 outbreak and we
continue to expect to determine a recommended Phase 2 dose in the
second half of 2020.
- CPI-0610 Phase 3 clinical trial. Conditions at clinical trial
sites caused by COVID-19 may impact the timing of the start of our
Phase 3 clinical trial for CPI-0610. However, we still aim to begin
this trial in the second half of 2020.
- Manufacturing. We have experienced some disruption in our
supply chain due to COVID-19. However, supply chain disruptions
have not impacted our overall timelines for conducting clinical
trials to date, and we continue to manufacture batches for our
ongoing clinical trials.
Milestones
The Company anticipates achieving the following milestones
during 2020:
CPI-0610 – Provide MANIFEST program update at EHA in
June
CPI-0610 – Initiate Phase 3 clinical trial in second half
of 2020
CPI-0610 – Provide additional MANIFEST program update by
end of year
CPI-1205 – Provide ProSTAR program update and determine
next steps mid-year
CPI-0209 – Provide program update, including recommended
Phase 2 dose, by end of year
First Quarter 2020 Financial Results
- Cash, cash equivalents, and marketable securities as
of March 31, 2020, were $358.8 million, a decrease of
6.5% compared to December 31, 2019, primarily due to
operating expenses.
- Research and development (R&D) expenses increased 28.1%
year over year to $20.1 million in the first quarter of
2020, mainly due to increased clinical trial expenses.
- General and administrative (G&A) expenses grew 33.4% year
over year to $5.9 million in the first quarter of 2020,
primarily due to building out the organization of the company.
- The net loss attributed to common shareholders increased 31.0%
year over year to $25.4 million for the first quarter of 2020,
mainly due to increased R&D and G&A expenses. The net loss
per share attributable to common shareholders decreased 18.7% to
$0.61 per share due to an increase in shares outstanding as a
result of the private placement in October 2019 and the public
offering in December 2019, offset in part by the increased net
loss.
Financial Guidance
Constellation expects that its current cash, cash
equivalents, and marketable securities will enable it to fund
operations into the second half of 2022.
Results of Operations (unaudited)
|
Three months ended March 31, |
|
(In thousands, except share
and per-share amounts) |
2020 |
|
|
2019 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
20,075 |
|
|
$ |
15,677 |
|
General and administrative |
|
5,908 |
|
|
|
4,429 |
|
Total operating expenses |
|
25,983 |
|
|
|
20,106 |
|
Loss from operations |
|
(25,983 |
) |
|
|
(20,106 |
) |
Other income (expense): |
|
|
|
|
|
|
|
Interest income |
|
1,404 |
|
|
|
755 |
|
Interest expense |
|
(850 |
) |
|
|
(75 |
) |
Total other income (expense), net |
|
554 |
|
|
|
680 |
|
Loss before income taxes |
|
(25,429 |
) |
|
|
(19,426 |
) |
Income tax expense |
|
15 |
|
|
|
— |
|
Net loss |
$ |
(25,444 |
) |
|
$ |
(19,426 |
) |
Net loss per share attributable
to common stockholders,basic and diluted |
$ |
(0.61 |
) |
|
$ |
(0.75 |
) |
Weighted average number of common
shares used in net loss per shareattributable to common
stockholders, basic and diluted |
|
41,765,635 |
|
|
|
25,804,595 |
|
|
|
|
|
|
|
|
|
Comprehensive loss: |
|
|
|
|
|
|
|
Net loss |
$ |
(25,444 |
) |
|
$ |
(19,426 |
) |
Other comprehensive gain
(loss) |
|
|
|
|
|
|
|
Unrealized gain (loss) on marketable securities |
|
(84 |
) |
|
|
9 |
|
Total other comprehensive gain (loss) |
$ |
(84 |
) |
|
$ |
9 |
|
Comprehensive loss |
$ |
(25,528 |
) |
|
$ |
(19,417 |
) |
Consolidated Balance Sheets (unaudited)
|
March 31, |
|
December 31, |
(In $ thousands) |
2020 |
|
2019 |
Cash and cash equivalents |
$ |
190,464 |
|
$ |
334,332 |
Marketable securities |
|
168,385 |
|
|
49,602 |
Total current assets |
|
361,666 |
|
|
386,989 |
Total assets |
|
373,061 |
|
|
399,130 |
Current liabilities |
|
19,285 |
|
|
22,755 |
Long-term debt, net of current
portion and discount |
|
29,681 |
|
|
29,642 |
Total liabilities |
|
57,535 |
|
|
61,546 |
Total stockholders’
equity |
|
315,526 |
|
|
337,584 |
Conference Call
Constellation will host a conference call at 8:00 AM EDT on May
6, 2020, to discuss its clinical programs and financial results.
The event will be webcast live and can be accessed on the Investor
Relations section of Constellation’s website at
http://ir.constellationpharma.com/events-and-presentations/events.
To participate in the live question-and-answer session, please dial
(877) 473-2077 (domestic) or (661) 378-9662 (international) and
refer to conference ID 4372778.
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
that involve substantial risks and uncertainties, including
statements regarding the Company’s plans, strategies and prospects
for its business and statements regarding the development status of
the Company’s product candidates, the timing of availability of
clinical trial data and the Company’s ability to fund its
operations until the second half of 2022. 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-0610, CPI-1205 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; raise the substantial additional
capital needed to achieve its business objectives; the COVID-19
pandemic and general economic and market conditions. 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. 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.
Contacts
Kia Khaleghpour, PhDVice President, Investor Relations and
CommunicationsConstellation Pharmaceuticals+1
617-844-6859kia.khaleghpour@constellationpharma.com
Ronald AldridgeSenior Director, Investor Relations Constellation
Pharmaceuticals+1
617-714-0539ron.aldridge@constellationpharma.com
Lauren ArnoldMedia RelationsMacDougall Biomedical
Communications+1 781-235-3060larnold@macbiocom.com
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