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• | PAH: Enrollment in the Phase 3 INOvation-1 study evaluating INOpulse® in patients with PAH now exceeds 100 patients, representing more than half of the anticipated enrollment. As previously agreed with the U.S. Food and Drug Administration (FDA), an interim analysis of this study will be performed by the Data Monitoring Committee when half of the subjects complete the 16-week blinded treatment phase. The interim analysis will determine if the study should be stopped early for efficacy or futility, continued as planned, or if the study size should be increased. The Company anticipates the readout of the interim analysis in mid-2018, and the availability of top-line data from the full study around the end of 2018. |
• | PH-ILD: Following positive results in its Phase 2a study in PH-IPF, Bellerophon has initiated and randomized the first patient in a Phase 2b study evaluating INOpulse to assess the safety and efficacy of pulsed, inhaled nitric oxide (iNO) versus placebo in patients with PH-ILD. A total of 40 subjects will be randomized in the double-blind, placebo-controlled clinical study, including patients with idiopathic pulmonary fibrosis. The primary endpoint of the study is the change in 6 Minute Walk Distance (6MWD) and the study includes several additional endpoints, including improvement in right ventricular function. Top-line results from this study are expected to be available by the end of 2018. |
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The decrease was due to reduced expenses payable to Ikaria as a result of the termination of the TSA transition service agreement effective September 30, 2015 and reduced personnel costs as a result of the restructuring that occurred in the second half of 2015.
The decrease was primarily due to reduced personnel and consulting costs as a result of the restructuring that occurred in the second half of 2015 and a reduction in expenses payable to Ikaria as a result of the termination of the TSA effective on September 30, 2015.
The decrease was driven by reduced expenses payable to Ikaria as a result of the termination of the TSA, reduced development costs for the INOpulse device and triple-lumen cannula and reduced personnel costs as a result of the restructuring that occurred in the second half of 2015.
Nonrefundable advance payments for goods or services that will be used or rendered for future research and development activities are deferred and are recognized as research and development expense as the related goods are delivered or the related services are performed.
This decrease was primarily due to reduced general and administrative expenses, reductions in research and development expenses pertaining to our development of BCM, reduced drug and delivery system costs, reduced research and development infrastructure expenses, and reduced INOpulse engineering expenses.
On May 9, 2017, we...Read more
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employee-related expenses, including salary, benefits...Read more
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Bellerophon Therapeutics, Inc. provided additional information to their SEC Filing as exhibits
Ticker: BLPH
CIK: 1600132
Form Type: 10-K Annual Report
Accession Number: 0001600132-18-000034
Submitted to the SEC: Thu Mar 15 2018 4:30:00 PM EST
Accepted by the SEC: Thu Mar 15 2018
Period: Sunday, December 31, 2017
Industry: Pharmaceutical Preparations