“I am pleased with the progress in our ongoing clinical programs to treat pulmonary hypertension in unmet or under-served chronic pulmonary disease areas,” stated
“Moreover, we expect to communicate the results of our Phase 2 trials for INOpulse therapy to treat significant unmet needs in pulmonary hypertension (PH) associated with chronic obstructive pulmonary disease (PH-COPD) and idiopathic pulmonary fibrosis (PH-IPF) during the middle of 2017,” added Mr. Tenenbaum. “Our clinical and operational progress has been complemented by strengthening our balance sheet with the completion of an equity financing last November.”
Key Highlights for 2016 and Business Update:
- The Company announced positive data in February from the final analysis of its Phase 2 long-term extension study of INOpulse for the treatment of Pulmonary Arterial Hypertension (PAH). This data demonstrated a sustained benefit and a favorable safety profile for long-term oxygen therapy patients who received the higher iNO 75 dose and stayed on the therapy for at least 12 hours a day.
The U.S. Food and Drug Administration( FDA) accepted modifications proposed by the Company to its Phase 3 program for INOpulse in the treatment of PAH. Under the newly modified accelerated Phase 3 program the INOvation-1 study, together with a second confirmatory randomized withdrawal study can serve as the two adequate and well-controlled studies to support a New Drug Application (NDA) filing for INOpulse in PAH. The randomized withdrawal study will recruit approximately 40 patients directly from the INOvation-1 study, thereby eliminating the need for recruiting additional patients. The accelerated program eliminates the need for a second standalone Phase 3 study resulting in significant reduction in overall cost and development time, including reducing the total planned patient enrollment from 470 subjects to 188 subjects.
- The Company initiated its Phase 3 PAH study, INOvation-1, incorporating the smaller and lighter next generation INOpulse device. Enrollment continues in INOvation-1, with topline results targeted in mid-2018 and an interim read expected around the end of 2017.
- The Company commenced a Phase 2 chronic treatment trial for the INOpulse therapy to treat pulmonary hypertension in chronic obstructive pulmonary disease, or PH-COPD. This follows positive results from the Company’s Phase 2a study and proof of mechanism work in PH-COPD. The results of the trial are expected in mid-2017.
- The Company started a Phase 2 trial to evaluate the acute and chronic benefit of the INOpulse therapy to treat patients with pulmonary hypertension in Idiopathic Pulmonary Fibrosis, or PH-IPF. The results of the trial are expected in mid-2017.
- The Company completed an equity financing in the fourth quarter, raising gross proceeds of
$12 million, which included new investments by four leading healthcare funds and significant investments by current shareholders, including New Mountain Capital, LLCand Linde North America, as well as directors and management.
- The Company successfully completed the transition of
Fabian Tenenbaum, Chief Financial Officer and Chief Business Officer, to Chief Executive Officer. Mr. Tenenbaum succeeds Jonathan Peacock, who retains his position as Chairman of the Board and will remain actively involved in the Company. In addition, Mary Ann Cloyd, was appointed as an independent director and Chair of the Board’s audit committee. Ms. Cloyd was a Senior Partner with PricewaterhouseCoopers(PwC) with responsibility for leading PwC’s Center for Board Governance.
- Management has streamlined the Company’s cost structure through a reduction in its infrastructure associated with the clinical results of Bioabsorbable Cardiac Matrix (BCM) and elimination of the Transition Services Agreement (TSA) with
Ikaria Inc.in September 2015.
Fourth Quarter 2016 Financial Results
For the fourth quarter ended
Research and development expenses for the fourth quarter of 2016 were
General and administrative expenses for the fourth quarter of 2016 were $2.2 million, a decrease of 14 percent from $2.5 million in the fourth quarter of 2015, primarily due to reduced consulting costs.
Full Year 2016 Financial Results
For the full year ended
Research and development expenses for the full year 2016 declined 50 percent to
General and administrative expenses for the full year 2016 declined 52 percent to $7.1 million, from $14.9 million in the full year 2015, primarily due to reduced personnel and consulting costs resulting from the 2015 restructuring and reduced expenses payable to Ikaria following the termination of the transition service agreement on
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 system. 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.
Any statements in this press release about Bellerophon’s future expectations, plans and prospects, including statements about the clinical development of its product candidates, regulatory actions with respect to the Company’s clinical trials and expectations regarding the sufficiency of the Company’s cash balance to fund clinical trials, operating expenses and capital expenditures, and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary or interim results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials will be indicative of the results of later clinical trials, expectations for regulatory approvals, the FDA’s substantial discretion in the approval process, availability of funding sufficient for our foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the “Risk Factors” section of the Company’s most recent filings with the
|Bellerophon Therapeutics, Inc.|
|Consolidated Balance Sheet|
|(in thousands except share and per share data)|
|December 31, 2016||December 31, 2015|
|Cash and cash equivalents||$||14,453||$||6,260|
|Prepaid expenses and other current assets||6,331||5,385|
|Total current assets||26,505||29,452|
|Restricted cash, non-current||307||457|
|Other non-current assets||1,491||6,701|
|Property and equipment, net||1,399||1,799|
|Liabilities and Stockholders' Equity|
|Accrued research and development||2,573||4,078|
|Due to Ikaria, Inc.||193||148|
|Total current liabilities||6,495||8,073|
|Common stock warrant liability||5,215||-|
|Commitments and contingencies|
|Common stock, $0.01 par value per share; 125,000,000 shares authorized, 31,702,624 and 13,130,800 shares issued and outstanding at December 31, 2016 and December 31, 2015, respectively||317||131|
|Preferred stock, $0.01 par value per share; 5,000,000 share authorized, zero shares issued and outstanding at December 31, 2016 and December 31, 2015||-||-|
|Additional paid-in capital||142,167||130,902|
|Accumulated other comprehensive income (loss)||-||(19||)|
|Total stockholders’ equity||17,992||30,336|
|Total liabilities and stockholders' equity||$||29,702||$||38,409|
|BELLEROPHON THERAPEUTICS, INC.|
|CONSOLIDATED STATEMENTS OF OPERATIONS|
|(unaudited, in thousands except share and per share data)|
|Quarter Ended Dec 31,||Year Ended Dec 31,|
|Research and development||$||5,111||$||8,329||$||16,650||$||33,365|
|General and administrative||2,181||2,533||7,107||14,870|
|Total operating expenses||7,292||10,862||23,757||48,235|
|Other operating income||-||-||-||1,667|
|Loss from operations||(7,292||)||(10,862||)||(23,757||)||(46,568||)|
|Change in fair value of common stock warrant liability||(590||)||-||(590||)||-|
|Loss before taxes||(7,861||)||(10,826||)||(24,252||)||(46,459||)|
|Income tax benefit||(438||)||-||(438||)||-|
|Weighted average shares outstanding:|
|Basic and diluted||20,186,996||13,026,816||15,057,627||12,267,693|
|Net loss per share:|
|Basic and diluted||$||(0.37||)||$||(0.83||)||$||(1.58||)||$||(3.79||)|
Contacts At Bellerophon:
Fabian Tenenbaum, Chief Executive Officer (908) 574-4767 At LifeSci Advisors: Bob Yedid(646) 597-6989 firstname.lastname@example.org