Constellation Pharmaceuticals Announces Third-Quarter and Nine-Month 2018 Financial Results
- Company Executing on Lead Programs CPI-1205 and CPI-0610
- Expects to Evaluate Proof of Concept for Both Programs in Mid-2019
“We are excited about the progress we have made this year with our clinical programs and our entire epigenetics platform,” said
- Continued enrollment in ProSTAR Phase 1b/2 study of CPI-1205 in metastatic castration-resistant prostate cancer (mCRPC). As planned, 34 sites are activated and enrolling patients in each of the two cohorts of the Phase 1b portion of the study. The Company expects to determine a recommended Phase 2 dose and begin the randomized portion of the trial in the fourth quarter of 2018.
- Enhanced and expanded the Phase 2 portion of the ongoing MANIFEST study of CPI-0610 in myelofibrosis (MF). Constellation modified the MANIFEST trial design to stratify for transfusion-dependent status in second-line treatment and to initiate a first-line treatment arm in combination with ruxolitinib in JAK 1/2-inhibitor-naïve patients with MF. These changes are intended to provide additional measures of potential clinical activity and to expand the potential addressable population of MF patients for CPI-0610, thereby enabling multiple potential paths to registration. More than a dozen sites are now open for MANIFEST in the US,
Canada, and Europe, with more sites expected to open in the next few months. Preliminary data in this trial as of May 25included evidence of reductions in spleen volume, improvements in symptom scores, and increased hemoglobin levels, as well as one case of a transfusion-dependent patient achieving transfusion independence.
- Announced Fast Track designation for CPI-0610 for the treatment of MF. The FDA awarded CPI-0610 Fast Track status based on preliminary results from the Phase 2 MANIFEST study. Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill unmet medical needs.
- Expanded Board of Directors with experts in mCRPC and MF. Constellation announced the appointments of Dr. Elizabeth G. Tréhu and Steven L. Hoerter to its Board of Directors, bringing considerable experience working in the disease areas of mCRPC and MF.
- Presenting preclinical data from EZH2 franchise in prostate cancer. Constellation will be presenting data at the upcoming EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics Symposium on
November 13-16in Dublin, Ireland, and at the AACR-KCA Joint Conference on Precision Medicinein Solid Tumors on November 15-17in Seoul, South Korea.
Third Quarter 2018 Financial Results
- Cash and cash equivalents as of September 30, 2018 grew 45% to
$128.5million compared to June 30, 2018, primarily due to capital raised in the initial public offering in July, partially offset by operating expenses.
- Research and development (R&D) expenses increased 66% year over year to $12.7 million in the third quarter of 2018 mainly due to increased clinical trial expenses.
- General and administrative (G&A) expenses grew 86% year over year to
$3.7million in the third quarter of 2018, primarily due to costs related to building out the organization as the Company evolved from a preclinical-stage company to a multi-candidate clinical-stage company, as well as costs associated with operating as a public company.
- The net loss attributable to common stockholders increased 9% year over year to $15.9 million mainly due to increases in G&A and R&D expenses, partly offset by the inclusion of unpaid cumulative dividends in 2017 that were waived in 2018. The net loss per share attributable to common stockholders decreased 95% to $0.81 per share for the third quarter of 2018 due to an increase in shares outstanding as a result of the initial public offering and conversion of the preferred stock to common stock.
We expect that cash as of September 30, 2018, will fund planned operations into the first quarter of 2020.
The Company continues to anticipate achieving the following milestones during the upcoming twelve months:
Fourth Quarter 2018
- Initiate the Phase 2 portion of the ProSTAR study with CPI-1205
- Determine safety and the recommended Phase 2 dose in the ORIOn-E trial for CPI-1205 in combination with checkpoint inhibitors in solid tumors
- Initiate the Phase 1 trial with CPI-0209, a second-generation EZH2 inhibitor
- Evaluate proof of concept for CPI-1205 in the ProSTAR trial
- Evaluate proof of concept for CPI-0610 in the MANIFEST trial
Financial Results (Unaudited)
Statements of operations and comprehensive loss (unaudited)
|Nine months ended September 30,||Three months ended September 30,|
|(In thousands, except share and per-share amounts)||2018||2017||2018||2017|
|Research and development||32,143||22,564||12,733||7,690|
|General and administrative||8,469||4,636||3,680||1,981|
|Total operating expenses||40,612||27,200||16,413||9,671|
|Other income (expense):|
|Change in fair value of preferred stock tranche liability||—||4,443||—||90|
|Total other income (expense), net||631||3,755||475||(111||)|
|Net loss and comprehensive loss||(39,981||)||(23,445||)||(15,938||)||(9,782||)|
|Cumulative dividends on convertible preferred stock||—||(13,342||)||—||(4,818||)|
|Net loss attributable to common stockholders||$||(39,981||)||$||(36,787||)||$||(15,938||)||$||(14,600||)|
|Net loss per share attributable to common stockholders, basic and diluted||$||(5.45||)||$||(38.43||)||$||(0.81||)||$||(15.18||)|
|Weighted average common shares outstanding, basic and diluted||7,332,052||957,139||19,619,239||961,838|
Balance sheets (unaudited)
|(In $ thousands)||September 30, 2018||December 31, 2017|
|Cash and cash equivalents||$||128,475||$||16,404|
|Other current assets||3,537||1,318|
|Convertible preferred stock||—||173,228|
|Total stockholders’ equity (deficit)||$||122,563||$||(165,833||)|
Note: Abbreviated financial statements; please refer to Form 10-Q for more details, including explanatory notes.
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, the anticipated benefits of the changes to its clinical trial protocols and its anticipated achievement of milestones, including determination of proof of concept. 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
MacDougall Biomedical Communications
Source: Constellation Pharmaceuticals