Constellation Pharmaceuticals Announces Second-Quarter and Six-Month 2019 Financial Results
- Data presented at
ASCOand EHA suggest potential disease-modifying activity of CPI-0610 across the spectrum of myelofibrosis (MF) parameters, with multiple potential pathways for approval
- The EZH2 franchise continues to advance: the ProSTAR study of CPI-1205 remains on track, and the IND for CPI-0209 was filed and cleared by the
“2019 is a year of data for Constellation,” said
“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.”
- Data presented at
ASCOand 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.
- 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
- CPI-0209 could address additional patient populations beyond those targeted by first-generation EZH2 inhibitors.
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.
- 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
$4.9million 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
$0.80per 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
$9.3million 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 $1.56 per share due to an increase in shares outstanding as a result of the initial public offering in 2018 and conversion of preferred stock to common stock.
Constellation expects that cash, cash equivalents, and marketable securities as of
|Constellation Pharmaceuticals, Inc.
|Consolidated Statements of Operations and Comprehensive Loss
|Six months ended June 30,||Three months ended June 30,|
|(In thousands, except share and per-share amounts)||2019||2018||2019||2018|
|Research and development||31,632||19,410||15,955||9,536|
|General and administrative||9,315||4,789||4,886||2,486|
|Total operating expenses||40,947||24,199||20,841||12,022|
|Loss from operations||(40,947||)||(24,199||)||(20,841||)||(12,022||)|
|Other income (expense):|
|Total other income (expense), net||754||156||74||81|
|Net loss attributable to common stockholders||(40,193||)||(24,043||)||(20,767||)||(11,941||)|
|Other comprehensive gain|
|Unrealized gain on marketable securities||11||—||2||—|
|Total other comprehensive gain||11||—||2||—|
|Net loss per share attributable to common stockholders, basic and diluted||$||(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,
|Cash and cash equivalents||$||55,043||$||114,592|
|Total current assets||100,666||117,303|
|Long-term debt, net of current portion and discount||19,568||—|
|Total stockholders’ equity||$||67,184||$||104,158|
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
Senior Director, Investor Relations
MacDougall Biomedical Communications
Source: Constellation Pharmaceuticals