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 and six-month 2018 financial results.
“We at Constellation are pleased to report our financial results
for the first time as a public company,” said Jigar Raythatha,
president and chief executive officer of Constellation
Pharmaceuticals. “We are focusing our efforts and investing
the capital that we raised in our recent crossover round and IPO
with the goal of building a broad portfolio of important
epigenetics-based medicines to serve inadequately treated cancer
patients.
“We have many things to be excited about in the months ahead,”
Mr. Raythatha continued. “Our robust epigenetics platform has
delivered multiple programs into the clinic that are testing
differentiated approaches to treating cancer. These programs
have provided encouraging preliminary clinical data, details of
which we disclosed in our IPO prospectus. We look forward to
providing further updates on the progress of our two lead programs
in metastatic castration-resistant prostate cancer and
myelofibrosis, including evaluation of proof of concept in
mid-2019. We aim to expand on this clinical pipeline with new
drug candidates generated by our epigenetics platform.”
In conjunction with the Company’s IPO, Constellation is
expanding its leadership team. To that end, in July the
Company appointed Karen Valentine as Chief Legal Officer and
General Counsel. “We are thrilled to have someone with
Karen’s extensive legal and business experience in the biotech
space join Constellation,” Mr. Raythatha concluded. “We
welcome her and will benefit considerably from her leadership.”
News
- On July 18, the Company priced its IPO of 4,000,000 shares at a
price of $15.00 per share, for gross proceeds of $60 million,
before underwriting discounts and commissions and offering expenses
payable by the Company. On July 19, the Company’s common
stock began trading on the Nasdaq Global Select Market under the
symbol “CNST.” The IPO closed on July 23.
- On July 16, the Company appointed Karen Valentine as Chief
Legal Officer and General Counsel. Ms. Valentine joins
Constellation after serving as Chief Legal Officer and General
Counsel of Agenus Inc.
- In June, two scientific publications preclinically validated
the role of the EZH2 inhibitor CPI-1205 in cancer immunotherapy.
CPI-1205’s potential effect as an immunotherapy was first
established through the Company’s collaboration with the laboratory
of Dr. Padmanee Sharma at MD Anderson Cancer Center. The work
is documented in “Modulation of EZH2 Expression in T Cells Improves
Efficacy of anti-CTLA-4 Therapy,” which was published in the
Journal of Clinical Investigation. Constellation also
contributed CPI-1205 product to a study by the laboratories of Dr.
Jeffrey Bluestone at UCSF and Dr. Michel DuPage at UC Berkeley
discussed in the article “Targeting EZH2 Reprograms Intratumoral
Regulatory T Cells to Enhance Cancer Immunity,” published in Cell
Reports. These studies support the rationale for the
Company’s ORIOn-E trial.
- On April 9, the Company announced completion of a $100 million
financing, with funds provided by both existing and new investors.
The Company plans to utilize the proceeds of this financing
and of its IPO to advance its multiple clinical trials, including
the ongoing ProSTAR and ORIOn-E trials for CPI-1205 and the ongoing
MANIFEST trial for CPI-0610, to continue development of CPI-0209,
and to advance its preclinical pipeline.
Second Quarter 2018 Financial Results
- Cash and cash equivalents as of June 30, 2018 grew 24% to
$88.5 million compared to March 31, 2018, primarily due
to capital raised in a preferred stock offering in April, partially
offset by operating expenses. This cash balance did not
reflect proceeds from the IPO, which occurred in July.
- Research and development (R&D) expenses increased 19% year
over year to $9.5 million in the second quarter of 2018
mainly due to increased CPI-1205 clinical trial
expenses.
- General and administrative (G&A) expenses grew 67% year
over year to $2.5 million in the second quarter of 2018,
primarily due to increased personnel costs related to building out
the organization as the Company evolves from a preclinical-stage
company to a multi-candidate clinical-stage company, as well as
costs associated with the IPO.
- The net loss attributable to common stockholders decreased 3%
year over year to $11.9 million and decreased 22%
to $9.96 per share for the second quarter of
2018.
Financial Guidance The Company expects that its
cash and cash equivalents as of June 30, 2018, together
with the proceeds of the IPO, will fund planned operations into the
first quarter of 2020.
Overview of Key Programs
ProSTAR: CPI-1205 is a small molecule designed
to promote anti-tumor activity by specifically inhibiting EZH2, an
enzyme that suppresses target gene expression. The ProSTAR
trial is an open-label Phase 1b/2 clinical trial of CPI-1205 in
combination with either abiraterone acetate or enzalutamide, which
are androgen receptor signaling (ARS) inhibitors, in patients with
metastatic castration-resistant prostate cancer (mCRPC) who
previously progressed on treatment with one of these ARS
inhibitors. In the Phase 1b portion of this trial, the
Company is aiming to establish safety, pharmacokinetics,
pharmacodynamics, maximum tolerated dose and a recommended Phase 2
dose of CPI-1205 in combination with these agents. The
Company has observed preliminary evidence of clinical activity in
the Phase 1b portion of this trial. In the randomized Phase 2
portion, the Company will aim to assess the response rate of a
selected combination of CPI-1205 and one of these ARS inhibitors
compared to that of the ARS inhibitor alone.
ORIOn-E: In accordance with the Company’s
franchise approach to targeting EZH2, the Company has initiated the
ORIOn-E trial, a Phase 1b/2 clinical trial of CPI-1205 in
combination with ipilimumab or pembrolizumab for the treatment of
patients with solid tumors who have previously progressed on
treatment with an immune checkpoint inhibitor that inhibits PD-L1
or PD-1. In the Phase 1b portion of the trial, the Company
seeks to establish the safety, pharmacokinetics, maximum tolerated
dose, and recommended Phase 2 dose of the combination.
MANIFEST: CPI-0610 is a potent and selective
small molecule designed to promote anti-tumor activity by
selectively inhibiting the function of BET proteins to decrease the
expression of abnormally expressed genes in cancer. In
MANIFEST, an open-label Phase 2 clinical trial, the Company is
evaluating CPI-0610 as a second-line treatment for patients with
myelofibrosis (MF), a progressive hematological cancer. The
Company is studying CPI-0610 in combination with ongoing
ruxolitinib treatment in MF patients who have experienced disease
progression, and as a monotherapy in MF patients not eligible for,
or no longer on, ruxolitinib. The Company aims to evaluate
safety, pharmacokinetics, reduction in spleen volume,
patient-reported symptom improvement and improvements in
red-blood-cell transfusion independence rate in patients who were
transfusion dependent at baseline.
CPI-0209: Also in accordance with our franchise
approach to targeting EZH2, the Company has developed a
second-generation EZH2 inhibitor, CPI-0209, and is currently
conducting IND-enabling studies. The Company expects to
provide additional updates on the development of CPI-0209 in the
context of its EZH2 franchise approach in 2019.
In all of the above referenced clinical trials, the Company
plans to collect and analyze biomarkers to assess the biology of
the EZH2 or BET proteins, which may allow the Company to enrich for
patients who are most likely to respond to
treatment.
Anticipated Milestones
The Company anticipates the following upcoming milestones:
Late 2018
Initiate Phase 2 portion of ProSTAR trial for CPI-1205
Early 2019
Determine safety and recommended Phase 2 dose (RP2D) in ORIOn-E
trial for CPI-1205
Mid 2019
Evaluate proof of concept for CPI-1205 in the ProSTAR trial
Evaluate proof of concept for CPI-0610 in the MANIFEST trial
Select Financial Information
Statements of operations and comprehensive loss (unaudited)
|
Six months ended June 30, |
Three months ended June 30, |
($ in thousands, except share and per-share amounts) |
|
2018 |
|
|
2017 |
|
|
2018 |
|
|
2017 |
|
Revenue |
$ |
— |
|
$ |
— |
|
$ |
— |
|
$ |
— |
|
Operating expenses: |
|
|
|
|
Research and development |
|
19,410 |
|
|
14,874 |
|
|
9,536 |
|
|
8,022 |
|
General and administrative |
|
4,789 |
|
|
2,655 |
|
|
2,486 |
|
|
1,490 |
|
Total operating expenses |
|
24,199 |
|
|
17,529 |
|
|
12,022 |
|
|
9,512 |
|
Loss from operations |
|
(24,199 |
) |
|
(17,529 |
) |
|
(12,022 |
) |
|
(9,512 |
) |
Other income (expense): |
|
|
|
|
Interest income |
|
377 |
|
|
66 |
|
|
268 |
|
|
32 |
|
Interest expense |
|
(221 |
) |
|
(553 |
) |
|
(187 |
) |
|
(255 |
) |
Change in fair value of preferred stock tranche liability |
|
— |
|
|
4,353 |
|
|
— |
|
|
1,743 |
|
Total other income, net |
|
156 |
|
|
3,866 |
|
|
81 |
|
|
1,520 |
|
Net loss and comprehensive loss |
|
(24,043 |
) |
|
(13,663 |
) |
|
(11,941 |
) |
|
(7,992 |
) |
Cumulative dividends on convertible preferred stock |
|
— |
|
|
(8,524 |
) |
|
— |
|
|
(4,327 |
) |
Net loss attributable to common stockholders |
$ |
(24,043 |
) |
$ |
(22,187 |
) |
$ |
(11,941 |
) |
$ |
(12,319 |
) |
Net loss per share attributable to common stockholders, basic and
diluted |
$ |
(22.12 |
) |
$ |
(23.24 |
) |
$ |
(9.96 |
) |
$ |
(12.81 |
) |
Weighted average common shares outstanding, basic and diluted |
|
1,086,697 |
|
|
954,750 |
|
|
1,199,164 |
|
|
961,431 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance sheets (unaudited)
(In $ thousands) |
June 30, 2018 |
December 31, 2017 |
Cash and cash equivalents |
$ |
88,540 |
|
$ |
16,404 |
|
Other current assets |
|
2,065 |
|
|
1,318 |
|
Total assets |
|
94,622 |
|
|
19,103 |
|
Current liabilities |
|
9,413 |
|
|
11,131 |
|
Total liabilities |
|
10,003 |
|
|
11,708 |
|
Convertible preferred stock |
|
272,834 |
|
|
173,228 |
|
Total stockholders’ deficit |
$ |
(188,215 |
) |
$ |
(165,833 |
) |
|
|
|
|
|
|
|
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. With a decade of
experience in the field, the Company has a deep understanding of
how epigenetic regulators modulate gene expression in cancer cells
and in the tumor and immune microenvironment. Constellation
is translating these insights to advance the company’s two lead
clinical programs, the EZH2 inhibitor CPI-1205 for metastatic
castration-resistant prostate cancer and solid tumors and the BET
inhibitor CPI-0610 for myelofibrosis, and to explore other novel
targets for which cancer epigenetics may enhance outcomes over
currently available treatment options.
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 development status of the Company’s
product candidates, its anticipated achievement of milestones and
its ability to fund its operations with cash on hand. 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;
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 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, and other important factors, 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.
Contact
Ronald Aldridge Investor RelationsConstellation
Pharmaceuticals+1
617-714-0539ron.aldridge@constellationpharma.com
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