On August 7, 2019 Constellation Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company using its expertise in epigenetics to discover and develop novel therapeutics, reported its second-quarter and six-month 2019 financial results (Press release, Constellation Pharmaceuticals, AUG 7, 2019, View Source [SID1234538296]).

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"2019 is a year of data for Constellation," said Jigar Raythatha, president and chief executive officer of Constellation Pharmaceuticals. "We made multiple important data presentations in the second quarter that help to advance our vision of becoming a late-stage oncology development company, with an exciting pipeline of development and discovery programs.

"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."

Program Updates

CPI-0610

Data presented at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) 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.
EZH2 Franchise

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 FDA.

CPI-0209 could address additional patient populations beyond those targeted by first-generation EZH2 inhibitors.
Milestones

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.
EZH2 Franchise

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 $4.9 million 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 $0.80 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.
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 $9.3 million 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.
Financial Guidance

Constellation expects that cash, cash equivalents, and marketable securities as of June 30, 2019, will enable the Company to fund planned operating expenses and capital expenditure requirements until late third-quarter 2020.