On November 8, 2018 Constellation Pharmaceuticals, Inc., (Nasdaq: CNST) a clinical-stage biopharmaceutical company using its expertise in epigenetics to discover and develop novel therapeutics, reported its third-quarter and nine-month 2018 financial results (Press release, Constellation Pharmaceuticals, NOV 8, 2018, View Source [SID1234531184]).

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"We are excited about the progress we have made this year with our clinical programs and our entire epigenetics platform," said Jigar Raythatha, president and chief executive officer of Constellation Pharmaceuticals. "In 2019, we look forward to further progress in our pipeline, as we expect to evaluate proof of concept for both our ProSTAR and MANIFEST clinical trials in mid-2019 as well as initiate clinical development of our second-generation EZH2 inhibitor CPI-0209."

Recent News

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 25 included 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 (Free EORTC-NCI-AACR Whitepaper) Molecular Targets and Cancer Therapeutics Symposium on November 13-16 in Dublin, Ireland, and at the AACR (Free AACR Whitepaper)-KCA Joint Conference on Precision Medicine in Solid Tumors on November 15-17 in Seoul, South Korea.
Third Quarter 2018 Financial Results

Cash and cash equivalents as of September 30, 2018 grew 45% to $128.5 million 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 $3.7 million 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.
Financial Guidance

We expect that cash as of September 30, 2018, will fund planned operations into the first quarter of 2020.

Anticipated Milestones

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
Early 2019

Determine safety and the recommended Phase 2 dose in the ORIOn-E trial for CPI-1205 in combination with checkpoint inhibitors in solid tumors
Mid 2019

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)

Constellation Pharmaceuticals, Inc.
Statements of operations and comprehensive loss (unaudited)