Bellerophon Therapeutics, Inc.

For 2015, net loss was $46.5 million versus $59.7 million in 2014. Research and development expense was $33.4 million, down from $46.0 million, while general and administrative expense was $14.9 million versus $13.8 million a year earlier. Cash, cash equivalents, restricted cash and marketable securities were $24.5 million at Dec. 31, 2015, compared with $27.6 million in 2014, and that included $14.6 million in prepayments for R&D under amended supply/CRO agreements. Management said it believes existing cash plus planned GCF funding can support operations through completion of the first PAH phase 3 trial and planned 2016 testing in COPD and pulmonary fibrosis. On guidance, the company expects first PAH patients enrolled early next quarter, the first PAH phase 3 study completed in the first half of 2018, PH-COPD testing to begin in the second quarter of 2016 with results by year-end 2016, and PH-IPF phase 2 to begin in the first half of 2016 with results by year-end 2016.

John Peacock framed 2015 as an important transitional year and emphasized that the company is now in a much stronger regulatory and operational position. He highlighted FDA approval of the new INOpulse device, EMA protocol alignment, EC certification in Europe, and progress on supply chain manufacturing as key steps that cleared the way for phase 3. His tone was confident but pragmatic: he repeatedly stressed realism around enrollment and funding, while saying the team is prepared to execute on a broad 2016 clinical agenda.

Fabian Tenenbaum said the company narrowed its 2015 net loss to $46.5 million from $59.7 million, with R&D falling to $33.4 million from $46.0 million because BCM development was halted and the PH-COPD phase 2-A trial had been completed in 2014. G&A rose to $14.9 million from $13.8 million, mainly due to one-time restructuring charges in the second half of 2015. He reported $24.5 million in cash, cash equivalents, restricted cash and marketable securities at year-end and cited the GCF agreement as a potential source of up to $20 million in additional funding; later management said 2016 cash burn is now expected to be closer to $20 million, with 2017 still about $15 million. The company also noted that $14.6 million of prepayments for trial and cartridge supply will be reflected differently in cash versus accounting going forward.

Analysts focused on enrollment timing, the size and design of the PH-IPF study, and how far cash would last. Management said PAH enrollment should be roughly a little below the historical median but could run faster, and noted the trial is not in a crowded field. For PH-IPF, Peacock said it is a very small, single-digit-patient study intended to show mechanism and short-term changes in six-minute walk distance rather than to be statistically powered. On funding, management said the second PAH phase 3 study is not yet funded and could require another $20 million to $25 million to get to the point of readout from the first phase 3 study.