Constellation Pharmaceuticals Announces Second-Quarter 2020 Financial Results, Provides Regulatory Update
05 Août 2020 - 1:00PM
Constellation Pharmaceuticals, Inc. (Nasdaq: CNST), a
clinical-stage biopharmaceutical company using its expertise in
epigenetics to discover and develop novel therapeutics, today
announced its second-quarter 2020 financial results. Constellation
also announced its plans for a Phase 3 clinical trial of the BET
inhibitor CPI-0610 following scientific advice and regulatory
meetings with the U.S. Food and Drug Administration (FDA).
The Company is preparing to initiate a global, randomized,
double-blind, pivotal Phase 3 clinical trial for CPI-0610, to be
called MANIFEST-2, in the second half of 2020. MANIFEST-2 is
designed to enroll approximately 310 JAK-inhibitor-naïve patients
with advanced primary myelofibrosis (MF),
post-essential-thrombocythemia MF, or post-polycythemia-vera MF.
Patients will be randomized 1:1 to CPI-0610 plus ruxolitinib or
placebo plus ruxolitinib. The primary endpoint will be spleen
volume reduction at 24 weeks, and the key secondary endpoint will
be Total Symptom Score measured by Myelofibrosis Symptom Assessment
Form version 4.0 at 24 weeks.
The Company plans to continue to explore other regulatory
pathways for bringing CPI-0610 to MF patients.
“Having seen signals of clinical benefit for CPI-0610 in
patients with MF as well as preliminary evidence of disease
modification, we are pleased that we have aligned with the FDA on
the design of the pivotal trial, MANIFEST-2,” said Jigar Raythatha,
president and chief executive officer of Constellation
Pharmaceuticals. “We look forward to continuing the constructive
dialogue we have had with the FDA and are committed to bringing
CPI-0610 to patients in need as soon as possible.”
Program Updates
CPI-0610
- On June 12, 2020, Constellation presented an update of MANIFEST
data as of an April 17, 2020, data cutoff in three posters at the
European Hematology Association meeting, which are shown on
Constellation’s website. Constellation plans to provide its next
MANIFEST update, including both clinical and translational data, by
the end of 2020.
- To expand the use of CPI-0610 into indications for other
hematologic malignancies, the Company announced today that it
intends to explore the potential for CPI-0610 in approximately 20
patients with high-risk essential thrombocythemia (ET) who are
intolerant of, or refractory to, hydroxyurea by initiating a new
arm of MANIFEST in the second half of 2020.
CPI-0209
- We are currently conducting the Phase 1 dose escalation portion
of a Phase 1/2 clinical trial of the EZH2 inhibitor CPI-0209 in
solid tumors, which is proceeding as planned. After determining the
recommended Phase 2 dose for the monotherapy, which we expect to
accomplish in 2020, we intend to pursue monotherapy expansion arms
in selected solid tumor indications with a biomarker enrichment
strategy. We will also determine the recommended Phase 2 dose in
combination therapy and then pursue expansion arms for this
combination therapy.
Leadership Updates
During the second quarter, Constellation strengthened its board
of directors and senior management with two appointments:
- On April 6, Dr. Richard Levy was appointed to the board of
directors. Dr. Levy has nearly 30 years of experience in the
pharmaceutical and biotechnology sectors, where he held senior
clinical development positions at Incyte, Celgene, DuPont
Pharmaceuticals, and Sandoz / Novartis. He served as Executive Vice
President and Chief Drug Development and Medical Officer at Incyte,
where from 2003 to 2016 he was responsible for the expansion of the
clinical development portfolio in oncology and inflammation.
- On June 22, Dr. Jeffrey Humphrey was appointed Chief Medical
Officer. Dr. Humphrey is a medical oncologist with over 20 years of
experience in drug development. Prior to joining Constellation, he
was Chief Development Officer at Kyowa Kirin Co., where he oversaw
development of the company’s global portfolio of experimental
therapeutics for Western markets. Dr. Humphrey began his work in
industry clinical research at Bristol-Myers Squibb and subsequently
served in management positions for early and late drug development
and medical affairs at Pfizer, Bayer, and Bristol-Myers
Squibb.
Milestones
The Company anticipates achieving the following milestones
during 2020:
CPI-0610 – Initiate Phase 3 clinical trial in the second half of
2020
CPI-0610 – Provide additional MANIFEST program update by end of
year
CPI-0209 – Provide program update, including recommended Phase 2
dose, by end of year
Second Quarter 2020 Financial Results
- Cash, cash equivalents, and marketable securities as
of June 30, 2020, were $520.5 million, an increase of
35.6% compared to December 31, 2019, primarily due to
gross proceeds of $192.5 million from the public offering in June
2020, offset by operating expenses.
- Research and development (R&D) expenses increased 41.8%
year over year to $22.6 million in the second quarter of
2020, mainly due to increased clinical trial expenses.
- General and administrative (G&A) expenses grew 42.4% year
over year to $7.0 million in the second quarter of 2020,
primarily due to building out the organization of the company.
- The net loss attributed to common shareholders increased 43.3%
year over year to $29.8 million for the second quarter of
2020, mainly due to increased R&D and G&A expenses. The net
loss per share attributable to common shareholders decreased 12.5%
to $0.70 per share due to an increase in shares outstanding as a
result of the private placement in October 2019 and the public
offerings in December 2019 and June 2020, offset in part by the
increased net loss.
First Half 2020 Financial Results
- Research and development (R&D) expenses increased 35.0%
year over year to $42.7 million in the first half of
2020, mainly due to increased clinical trial expenses.
- General and administrative (G&A) expenses grew 38.1% year
over year to $12.9 million in the first half of 2020,
primarily due to building out the organization of the company.
- The net loss attributed to common shareholders increased 37.3%
year over year to $55.2 million for the first half of 2020,
mainly due to increased R&D and G&A expenses. The net loss
per share attributable to common shareholders decreased 16.0% to
$1.31 per share due to an increase in shares outstanding as a
result of the private placement in October 2019 and the public
offerings in December 2019 and June 2020, offset in part by the
increased net loss.
Financial Guidance
Constellation expects that its current cash, cash
equivalents, and marketable securities will fund operations into
mid-2023.
Results of Operations (unaudited)
|
|
Six months ended June 30, |
|
|
Three months ended June 30, |
|
($ in thousands, except share
and per-share amounts) |
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
42,702 |
|
|
$ |
31,632 |
|
|
$ |
22,627 |
|
|
$ |
15,955 |
|
General and administrative |
|
|
12,868 |
|
|
|
9,315 |
|
|
|
6,960 |
|
|
|
4,886 |
|
Total operating expenses |
|
|
55,570 |
|
|
|
40,947 |
|
|
|
29,587 |
|
|
|
20,841 |
|
Loss from operations |
|
|
(55,570 |
) |
|
|
(40,947 |
) |
|
|
(29,587 |
) |
|
|
(20,841 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
2,090 |
|
|
|
1,407 |
|
|
|
686 |
|
|
|
652 |
|
Gain on disposal of equipment |
|
|
29 |
|
|
|
— |
|
|
|
29 |
|
|
|
— |
|
Interest expense |
|
|
(1,707 |
) |
|
|
(653 |
) |
|
|
(857 |
) |
|
|
(578 |
) |
Total other income (expense), net |
|
|
412 |
|
|
|
754 |
|
|
|
(142 |
) |
|
|
74 |
|
Loss before income taxes |
|
|
(55,158 |
) |
|
|
(40,193 |
) |
|
|
(29,729 |
) |
|
|
(20,767 |
) |
Income tax expense |
|
|
39 |
|
|
|
— |
|
|
|
24 |
|
|
|
— |
|
Net loss |
|
$ |
(55,197 |
) |
|
$ |
(40,193 |
) |
|
$ |
(29,753 |
) |
|
$ |
(20,767 |
) |
Net loss per share attributable
to common stockholders, basic and diluted |
|
$ |
(1.31 |
) |
|
$ |
(1.56 |
) |
|
$ |
(0.70 |
) |
|
$ |
(0.80 |
) |
Weighted average number of common
shares used in net loss per share attributable to common
stockholders, basic and diluted |
|
|
42,177,523 |
|
|
|
25,807,132 |
|
|
|
42,589,415 |
|
|
|
25,809,556 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(55,197 |
) |
|
$ |
(40,193 |
) |
|
$ |
(29,753 |
) |
|
$ |
(20,767 |
) |
Other comprehensive gain: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain on marketable securities |
|
|
261 |
|
|
|
11 |
|
|
|
345 |
|
|
|
2 |
|
Total other comprehensive gain |
|
$ |
261 |
|
|
$ |
11 |
|
|
$ |
345 |
|
|
$ |
2 |
|
Comprehensive loss |
|
$ |
(54,936 |
) |
|
$ |
(40,182 |
) |
|
$ |
(29,408 |
) |
|
$ |
(20,765 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated Balance Sheets (unaudited)
|
|
June 30, |
|
|
December 31, |
|
($ in thousands) |
|
2020 |
|
|
2019 |
|
Cash and cash equivalents |
|
$ |
179,112 |
|
|
$ |
334,332 |
|
Marketable securities |
|
|
341,401 |
|
|
|
49,602 |
|
Total current assets |
|
|
523,099 |
|
|
|
386,989 |
|
Total assets |
|
|
534,798 |
|
|
|
399,130 |
|
Current liabilities |
|
|
27,284 |
|
|
|
22,755 |
|
Long-term debt, net of current
portion and discount |
|
|
27,569 |
|
|
|
29,642 |
|
Total liabilities |
|
|
62,817 |
|
|
|
61,546 |
|
Total stockholders’
equity |
|
|
471,981 |
|
|
|
337,584 |
|
|
|
|
|
|
|
|
|
|
Conference Call
Constellation will host a conference call at 8:00 AM EDT on
August 5, 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 5692388.
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 inhibitor CPI-0209 for the treatment of solid tumors. 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 clinical development and
regulatory plans, timelines, and prospects, the timing of
availability of clinical trial data and the Company’s ability to
fund its operations thru mi-2023. 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 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, Ph.D.Vice 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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