8-K
CHIASMA, INC filed this Form 8-K on 11/08/2018
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“During the third quarter, we continued to advance development of our investigational octreotide capsules product candidate for the maintenance treatment of adult acromegaly patients by completing enrollment of 56 patients in our CHIASMA OPTIMAL Phase 3 clinical trial, which should form the basis of an NDA filing,” said Mark Fitzpatrick, President and Chief Executive Officer of Chiasma. “Our decision to continue the enrollment of an additional 15 patients into the open-label MPOWERED trial will provide valuable real-world investigator and patient experience with octreotide capsules in the U.S. while the double-blind, placebo-controlled CHIASMA OPTIMAL trial is ongoing. The continuation of MPOWERED enrollment will also allow us to focus our limited resources on planned U.S. regulatory activities in 2019 and 2020. The filing, review and approval of a U.S. NDA for octreotide capsules remains our top priority over the next two years, and our U.S. clinical development plan remains on-track.”

Third Quarter 2018 Financial Results

 

 

G&A Expenses: General and administrative expenses were $2.3 million for the third quarter ended September 30, 2018, compared with $2.3 million for the same period of 2017. The current period results include increased legal fees which were primarily offset by a reduction in facility costs.

 

 

R&D Expenses: Research and development expenses were $5.5 million for the third quarter ended September 30, 2018, compared with $4.7 million for the same period of 2017. The increase was primarily due to costs related to the CHIASMA OPTIMAL clinical trial, which was initiated in September 2017.

 

 

Net Loss: For the quarter ended September 30, 2018, net loss was ($7.5) million, or ($0.31) per basic share, compared with ($6.8) million, or ($0.28) per basic share, in the same period of 2017.

 

 

Cash Position: Cash, cash equivalents and marketable securities as of September 30, 2018 were $48.1 million, compared with $66.9 million as of December 31, 2017, primarily reflecting the Company’s operating expenditures for the first nine months of 2018. The Company expects its existing cash, cash equivalents and marketable securities to fund operations through at least the anticipated release of top-line CHIASMA OPTIMAL data by September 2019 while supporting its MPOWERED trial in parallel.

CHIASMA OPTIMAL Phase 3 Trial

The CHIASMA OPTIMAL trial is a randomized, double-blind, placebo-controlled, nine-month clinical trial of octreotide capsules being conducted under a SPA agreement with the FDA. The trial enrolled 56 adult acromegaly patients whose disease was biochemically controlled, based upon levels of IGF-1, a byproduct of increased growth hormone (GH) levels caused by acromegaly, by injectable somatostatin analogs at baseline (average IGF-1 £ 1.0 × upper limit of normal (ULN)). The patients also had confirmed active acromegaly following their last surgical intervention based upon an elevated IGF-1 at that time of ³ 1.3 × ULN. The trial is randomized on a 1:1 basis, octreotide capsules versus placebo. Patients are being dose titrated from 40 mg per day to up to a maximum of 80 mg per day, equaling two capsules in the morning and two capsules in the evening. Patients who meet predefined withdrawal criteria in either treatment arm during the course of the trial will be considered treatment failures and revert to their original treatment of injections and will be monitored for the remainder of the trial. The primary endpoint of the trial is the proportion of patients who maintain their biochemical response compared to