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CAMBRIDGE, Mass., Nov. 06, 2019 (GLOBE NEWSWIRE) -- Constellation Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company using its expertise in epigenetics to discover and develop novel therapeutics, today announced its third-quarter and nine-month 2019 financial results.
“Our clinical programs continued to advance during the third quarter,” said Jigar Raythatha, president and chief executive officer of Constellation Pharmaceuticals. “We are particularly pleased with new MANIFEST data on CPI-0610 in myelofibrosis published today in abstracts by the American Society of Hematology (ASH). The data in the abstracts show signs of encouraging clinical activity in both JAK-inhibitor-naïve patients and ruxolitinib-refractory or -intolerant patients. Based on this activity, we have expanded the MANIFEST trial in first-line patients and in second-line transfusion-dependent patients to look more closely at these signals of activity. We plan to provide a further update on CPI-0610 in oral and poster presentations and at an investor event at the ASH meeting on December 9. Additionally, we have begun planning for a randomized Phase 3 clinical trial for CPI-0610 in JAK-inhibitor-naïve patients that we expect to begin in 2020.”
Two abstracts with preliminary data from the MANIFEST clinical trial from 59 enrolled patients as of June 27, 2019, the data cutoff date, were published today in association with ASH. The following are highlights from the abstracts:
Constellation provided a program update on CPI-1205:
Third Quarter 2019 Financial Results
Nine Month 2019 Financial Results
Constellation expects that its cash, cash equivalents, and marketable securities as of September 30, 2019, plus the $65 million of proceeds from a private placement completed on October 3, 2019, will enable the Company to fund planned operating expenses and capital expenditure requirements into the first half of 2021.
Results of Operations
|Constellation Pharmaceuticals, Inc.|
Consolidated Statements of Operations and
|Nine months ended
|Three months ended
|(In thousands, except share and per-share amounts)||2019||2018||2019||2018|
|Research and development||47,873||32,143||16,241||12,733|
|General and administrative||14,125||8,469||4,810||3,680|
|Total operating expenses||61,998||40,612||21,051||16,413|
|Loss from operations||(61,998||)||(40,612||)||(21,051||)||(16,413||)|
|Other income (expense):|
|Total other income (expense), net||656||631||(98||)||475|
|Net loss attributable to common stockholders||(61,342||)||(39,981||)||(21,149||)||(15,938||)|
|Other comprehensive gain (loss)|
|Unrealized gain (loss) on marketable securities||1||—||(10||)||—|
|Total other comprehensive gain (loss)||1||—||(10||)||—|
|Net loss per share attributable to common stockholders,
basic and diluted
|Weighted average common shares outstanding, basic
|Constellation Pharmaceuticals, Inc.|
|Consolidated Balance Sheets|
|(In $ thousands)||September 30,
|Cash and cash equivalents||$||78,977||$||114,592|
|Total current assets||92,210||117,303|
|Long-term debt, net of current portion and discount||29,603||—|
|Total stockholders’ equity||$||48,152||$||104,158|
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.
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, the Company’s plans, strategies and prospects for its business. All statements, other than statements of historical facts, contained in this press release, 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, 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 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-1205, 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; and raise the substantial additional capital needed to achieve its business objectives. 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, including the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2019. 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.
Senior Director, Investor Relations
MacDougall Biomedical Communications