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CAMBRIDGE, Mass., March 14, 2019 (GLOBE NEWSWIRE) -- Constellation Pharmaceuticals, Inc. (Nasdaq: CNST), a clinical-stage biopharmaceutical company using its expertise in epigenetics to discover and develop novel therapeutics, today announced its fourth-quarter and full-year 2018 financial results.
“2019 is a year of data for Constellation, and our clinical programs are making significant progress and approaching important readouts,” said Jigar Raythatha, president and chief executive officer of Constellation Pharmaceuticals.
“We are excited by preliminary data from our first four patients from the MANIFEST clinical trial, each showing one or more of the following: conversion from transfusion dependence to transfusion independence, hemoglobin increases, improvements in bone marrow fibrosis scores, spleen reductions, and symptom improvements. These results taken together suggest that CPI-0610 may have disease-modifying effects in myelofibrosis patients. We plan to present an interim update of data from MANIFEST from approximately 18-20 evaluable patients at a medical meeting in the second quarter of 2019.
“We also plan to present Phase 1b data from the ProSTAR clinical trial of CPI-1205 in metastatic castration-resistant prostate cancer in a poster at the American Association for Cancer Research annual meeting on April 1. Enrollment is on track in the Phase 2 portion of the ProSTAR trial, and we expect to provide an interim update of data of the Phase 2 portion at a medical meeting in the second half of 2019,” Mr. Raythatha continued.
“The Constellation team continues to work diligently toward becoming a late-stage oncology development company and bringing important new medicines to underserved cancer patients,” Mr. Raythatha concluded.
Fourth Quarter 2018 Financial Results
Full-Year 2018 Financial Results
We expect that our cash and cash equivalents as of December 31, 2018, will fund operating expenses and capital expenditure requirements into the second quarter of 2020.
The Company anticipates achieving the following milestones during 2019:
First Half 2019
Second Half 2019
Financial Results (Unaudited)
|Constellation Pharmaceuticals, Inc.|
|Consolidated Statements of Operations and Comprehensive Loss|
|Three months ended
|(In thousands, except share and per-share amounts)||2018||2017||2018||2017|
|Research and development||48,769||32,617||16,626||10,053|
|General and administrative||12,475||6,471||4,006||1,835|
|Total operating expenses||61,244||39,088||20,632||11,888|
|Loss from operations||(61,244||)||(39,088||)||(20,632||)||(11,888||)|
|Other income (expense):|
|Change in fair value of preferred stock tranche liability||—||4,443||—||—|
|Total other income (expense), net||1,319||3,711||688||(44||)|
|Net loss and comprehensive loss||(59,925||)||(35,377||)||(19,944||)||(11,932||)|
|Cumulative dividends on convertible preferred stock||—||(18,390||)||—||(5,048||)|
|Net loss attributable to common stockholders||(59,925||)||(53,767||)||(19,944||)||(16,980||)|
|Net loss per share attributable to common stockholders, basic and diluted||$||(5.00||)||$||(56.10||)||$||(0.77||)||$||(17.64||)|
|Weighted average common shares outstanding, basic and diluted||11,984,293||958,447||25,789,305||962,330|
|Constellation Pharmaceuticals, Inc.|
|Consolidated Balance Sheets|
|(In $ thousands)||December 31,
|Cash and cash equivalents||114,592||16,404|
|Other current assets||2,711||1,318|
|Convertible preferred stock||—||173,228|
|Total stockholders’ equity (deficit)||104,158||(165,833||)|
Note: Abbreviated financial statements; please refer to Form 10-K for more details, including explanatory notes.
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 EZH2 inhibitors CPI-1205 and CPI-0209 for the treatment of metastatic castration-resistant prostate cancer and other cancers as well as the BET inhibitor CPI-0610 for the treatment of myelofibrosis. 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 that involve substantial risks and uncertainties, including statements regarding the implications of preliminary clinical data, the development status of the Company’s product candidates, the Company’s plans for future data presentations, its anticipated achievement of milestones, including determination of proof of concept and its financial guidance regarding the period in which it will have capital available to fund its operations. 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; whether preliminary or interim results 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 its other product candidates; 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. 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. CPI-1205, CPI-0610, CPI-0209, and other product candidates are investigational in nature and have not yet been approved by the FDA or other regulatory authorities.
Senior Director, Investor Relations
MacDougall Biomedical Communications