Phase 3 trial for patients with PAH on track to start enrollment by year-end
Special Protocol Assessment (SPA) issued by
Company plans to continue Phase 2 testing in COPD and initiate clinical testing in Idiopathic Pulmonary Fibrosis (IPF)
“We also plan to continue Phase 2 testing with patients suffering Pulmonary Hypertension associated with COPD (PH-COPD) and to commence clinical testing with patients suffering Pulmonary Hypertension associated with Idiopathic Pulmonary Fibrosis (PH-IPF). We should have results from these tests by the end of 2016.”
The PAH Phase 3 program will include two confirmatory clinical trials, undertaken either sequentially or in parallel. A combined total of 450 patients are expected to be enrolled in these trials. Following the leadership team reorganization and restructuring of costs completed in September, the Company believes it has an experienced team and the cash resources to execute and complete the first of the two Phase 3 trials and the planned clinical testing in PH-COPD and PH-IPF.
Third Quarter 2015 Financial Results
For the third quarter of 2015, Bellerophon reported a net loss of
Research and development expenses for the third quarter of 2015 declined to
General and administrative expenses for the third quarter of 2015 increased to
Financial Highlights
As of
On
About Bellerophon
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 and cardiac diseases. The Company is currently developing two 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 intends to commence Phase 3 clinical trials in 2015, and the other for the treatment of pulmonary hypertension associated with chronic obstructive pulmonary disease (PH-COPD), which is in Phase 2 development. The Company is also planning to start testing the benefits of INOpulse for patients suffering from PH-IPF. For more information, please visit www.bellerophon.com.
Forward-looking Statements
Any statements in this press release about our future expectations, plans and prospects, including statements about clinical development of our product candidates and expectations regarding the sufficiency of our 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 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, 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 our most recent filings with the
| Bellerophon Therapeutics, Inc. | |||||||||||||
| Condensed Consolidated Statements of Operations | |||||||||||||
| (In thousands, except share/unit and per share/unit data) (Unaudited) | |||||||||||||
| Three Months Ended | Nine Months Ended | ||||||||||||
| September 30, | September 30, | ||||||||||||
| 2015 | 2014 | 2015 | 2014 | ||||||||||
| Operating expenses: | |||||||||||||
| Research and development | $ | 7,090 | $ | 11,559 | $ | 25,036 | $ | 36,368 | |||||
| General and administrative | 4,329 | 3,934 | 12,337 | 10,598 | |||||||||
| Total operating expenses | 11,419 | 15,493 | 37,373 | 46,966 | |||||||||
| Other operating income | 250 | - | 1,667 | - | |||||||||
| Loss from operations | (11,169 | ) | (15,493 | ) | (35,706 | ) | (46,966 | ) | |||||
| Interest Income | 27 | 13 | 73 | 61 | |||||||||
| Pre-tax loss | (11,142 | ) | (15,480 | ) | (35,633 | ) | (46,905 | ) | |||||
| Income tax benefit (expense) | - | - | - | - | |||||||||
| Net loss | $ | (11,142 | ) | $ | (15,480 | ) | $ | (35,633 | ) | $ | (46,905 | ) | |
| Weighted average shares/units outstanding: | |||||||||||||
| Basic and diluted | 12,911,905 | 7,897,143 | 12,012,002 | 7,898,041 | |||||||||
| Net loss per share/unit: | |||||||||||||
| Basic and diluted | $ | (0.86 | ) | $ | (1.96 | ) | $ | (2.97 | ) | $ | (5.94 | ) | |
| The accompanying notes are an integral part of these condensed consolidated financial statements. | |||||||||||||
| Bellerophon Therapeutics, Inc. | ||||||
| Condensed Consolidated Balance Sheet | ||||||
| (In thousands) (Unaudited) | ||||||
| September 30, 2015 | December 31, 2014 | |||||
| Assets | ||||||
| Current assets: | ||||||
| Cash and cash equivalents | $ | 23,908 | $ | 16,815 | ||
| Restricted cash | 3,863 | 9,264 | ||||
| Marketable securities | 17,391 | - | ||||
| Receivables - Due from Ikaria, Inc. | 250 | - | ||||
| Prepaid expenses and other current assets | 1,444 | 1,602 | ||||
| Total current assets | 46,856 | 27,681 | ||||
| Restricted cash, non-current | 457 | 1,548 | ||||
| Deferred transaction costs | - | 2,466 | ||||
| Property and equipment, net | 1,847 | 1,696 | ||||
| Total assets | $ | 49,160 | $ | 33,391 | ||
| Liabilities and Stockholders' / Members' Equity | ||||||
| Current liabilities: | ||||||
| Accounts payable | $ | 934 | $ | 376 | ||
| Accrued research and development | 3,041 | 6,666 | ||||
| Accrued expenses | 3,438 | 2,751 | ||||
| Due to Ikaria, Inc. | 1,231 | 661 | ||||
| Total current liabilities | 8,644 | 10,454 | ||||
| Total liabilities | 8,644 | 10,454 | ||||
| Total stockholders' / members' equity | 40,516 | 22,937 | ||||
| Total liabilities and stockholders' / members' equity | $ | 49,160 | $ | 33,391 | ||
Contact At Bellerophon:Amy Edmonds , Vice President Head of Clinical Operations & Administration (908) 574-4765At Rx Communications Group :Melody Carey (917) 322-2571 mcarey@rxir.com