Bellerophon Therapeutics, Inc. (NASDAQ:BLPH), a clinical-stage biotherapeutics company, today reported financial results for the third quarter ended September 30, 2016 and provided a business update.
“Overall, I am pleased to report good progress in our ongoing Phase 3 clinical trial to treat Pulmonary Arterial Hypertension (PAH), under an FDA-granted Special Protocol Assessment,” stated Jonathan Peacock, Chairman and Chief Executive Officer of Bellerophon Therapeutics. “We continue to initiate more sites and we are targeting to announce results in mid-2018. The Company also intends to take an interim look at the data through its data monitoring committee, currently planned by the end of the fourth quarter of 2017.
“Our Phase 2 trials for INOpulse therapy to treat pulmonary hypertension (PH) associated with chronic obstructive pulmonary disease (PH-COPD) and idiopathic pulmonary fibrosis (PH-IPF) have been initiated and are actively recruiting. We look forward to communicating results of each during the first quarter of 2017.
“Overall, we believe our proprietary INOpulse delivery technology is uniquely positioned to help these significant patient populations in areas of serious and unmet medical need,” concluded Mr. Peacock.
Key Highlights in the Third Quarter and Subsequent Weeks, Included:
|•||The INOvation-1 PAH Phase 3 clinical trial is targeting topline results in mid-2018 and an interim look by the end of the fourth quarter of 2017.|
|•||Terence K. Trow, MD, Associate Professor of Medicine, Yale Pulmonary Vascular Disease Program, presented “Continuous inhaled NO in the management of PAH” including Bellerophon INOPulse data and the INOvation-1 Phase 3 trial at the Annual meeting of the American College of Chest Physicians; October 2016.|
|•||The PH-COPD Phase 2 trial is actively recruiting patients with Belgian Health Authority approval following results from the Company’s previous Phase 2a study and proof of mechanism work indicating that INOpulse could be both safe and effective in PH-COPD.|
|•||In July, the Company announced the publication of results of a trial conducted by the Department of Respiratory Medicine at the University Hospital Antwerp, by Professor W. De Backer, MD and Bellerophon, in the peer-reviewed International Journal of COPD (Hajian et al., Pulmonary vascular effects of pulsed inhaled nitric oxide in COPD patients with pulmonary hypertension, International Journal of COPD, 2016, 11:1533-1541).|
During the quarter, the Company announced a succession plan in which Fabian Tenenbaum, current Chief Financial Officer and Chief Business Officer, will assume the position of Chief Executive Officer, succeeding Jonathan Peacock, who will retain his position as Chairman of the Board and remain actively involved. The transition is expected to be completed by the end of the year.
Third Quarter 2016 Financial Results
For the third quarter ended September 30, 2016, Bellerophon reduced its net loss to $4.2 million, from $11.1 million in the third quarter of 2015.
Research and development expenses for the third quarter of 2016 declined 65 percent to $2.5 million, from $7.1 million in the third quarter of 2015. The decrease was primarily due to the termination of the BCM development program in 2015 and the related reduction in infrastructure.
General and administrative expenses for the third quarter of 2016 declined 60 percent to $1.7 million, from $4.3 million in the third quarter of 2015, primarily due to reduced expenses payable to Ikaria following the termination of the transition service agreement on September 30, 2015, as well as reduced personnel and consulting costs resulting from the 2015 restructuring.
At September 30, 2016, the Company had cash and cash equivalents, restricted cash and marketable securities of $11.6 million compared to cash and cash equivalents, restricted cash and marketable securities of $24.5 million at December 31, 2015. As of September 30, 2016, the Company had $8.6 million in prepayments of research and development expenses related to its amended drug supply agreement with Ikaria and the clinical research organization it has partnered with for the first of the two Phase 3 clinical trials for INOpulse for PAH. The corresponding prepayments balance as of December 31, 2015 was $11.3 million. The Company believes that as of September 30, 2016 it has sufficient funds, together with its ATM program and along with alternatives available to the company, to satisfy its operating cash needs for at least the next 12 months.
Bellerophon Therapeutics is a clinical-stage biotherapeutics company focused on developing innovative therapies at the intersection of drugs and devices that address significant unmet medical needs in the treatment of cardiopulmonary diseases. The Company is currently developing three product candidates under its INOpulse program, a proprietary pulsatile nitric oxide delivery device. The first is for the treatment of pulmonary arterial hypertension (PAH), for which the Company has commenced Phase 3 clinical trials in 2016. The second is for the treatment of pulmonary hypertension associated with chronic obstructive pulmonary disease (PH-COPD) and the third candidate is for the treatment of pulmonary hypertension associated with Idiopathic Pulmonary Fibrosis (PH-IPF) both of which are in Phase 2 development. For more information, please visit www.bellerophon.com.