“During the first quarter, we advanced our clinical and operational plans,” stated
“We are also expecting to initiate two additional Phase 2 studies, one in Pulmonary Hypertension associated with COPD (PH-COPD) and one with Pulmonary Fibrosis (PH-IPF). For PH-COPD our study is designed to demonstrate the potential benefit of INOpulse on exercise following results from the Company’s Phase 2a study and its proof of mechanism work, showing that in an acute setting, the Company’s pulsed nitric oxide safely reduces PH for COPD patients and increases blood volume in the vessels within the lung. For PH-IPF the planned study will consist of an exploratory acute hemodynamic phase followed by a four week chronic use phase to evaluate exercise capacity.
“We are well positioned with a strong leadership team and the resources to advance each of our programs combining the well understood benefits of nitric oxide therapy with our innovative INOpulse® delivery system.”
Key Highlights during the First Quarter of 2016 and Subsequent Weeks, Included:
- The announcement in February of positive data from the Company’s Phase 2 long-term extension study of INOpulse for 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.
- Final confirmation from
FDA that the U.S. Phase 3 studies can commence under a Special Protocol Assessment (SPA), and an agreement with theEuropean Medicines Agency as to the protocol through aScientific Advice Working Party (SAWP). - Deployment of the new INOpulse system to patients participating in the Phase 2 PAH continuation program as well as shipment of the new device to Bellerophon’s U.S. distribution center to be used by patients enrolling in the Phase 3 study.
- In February, the appointment of
Fabian Tenenbaum to the post of Chief Financial Officer and Chief Business Officer, and Mary Ann Cloyd as an independent director and Chair of the Board’s audit committee. Both executives bring depth and expertise to their respective roles at Bellerophon.
First Quarter of 2016 Financial Results
For the first quarter ended
At
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 diseases. The Company is currently developing three product candidates under its INOpulse platform, a proprietary pulsatile nitric oxide delivery system. The first is for the treatment of pulmonary arterial hypertension (PAH), for which the Company intends to commence Phase 3 clinical trials in 2016. The second is for the treatment of pulmonary hypertension associated with chronic obstructive pulmonary disease (PH-COPD), which is in Phase 2 development, and the third candidate is for the treatment of pulmonary hypertension associated with Idiopathic Pulmonary Fibrosis (PH-IPF). The Company’s plans also call for the completion of further work on the use of INOpulse to treat PH-COPD and PH-IPF during 2016. For more information, please visit www.bellerophon.com.
Forward-looking Statements
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.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
(in thousands except share and per share data)
| Three Months Ended March 31, | |||||||||
| 2016 | 2015 | ||||||||
| Operating expenses: | |||||||||
| Research and development | $ | 5,113 | $ | 9,520 | |||||
| General and administrative | 1,976 | 4,573 | |||||||
| Total operating expenses | 7,089 | 14,093 | |||||||
| Other operating income | — | 1,166 | |||||||
| Loss from operations | (7,089 | ) | (12,927 | ) | |||||
| Interest income | 30 | 19 | |||||||
| Pre-tax loss | (7,059 | ) | (12,908 | ) | |||||
| Income tax benefit (expense) | — | — | |||||||
| Net loss | $ | (7,059 | ) | $ | (12,908 | ) | |||
| Weighted average shares outstanding: | |||||||||
| Basic and diluted | 13,053,007 | 10,152,487 | |||||||
| Net loss per share: | |||||||||
| Basic and diluted | $ | (0.54 | ) | $ | (1.27 | ) | |||
BELLEROPHON THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)
(in thousands except share and per share data)
| March 31, 2016 | December 31, 2015 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 1,270 | $ | 6,260 | ||||
| Marketable securities | 16,088 | 17,807 | ||||||
| Prepaid expenses and other current assets | 5,727 | 5,385 | ||||||
| Total current assets | 23,085 | 29,452 | ||||||
| Restricted cash, non-current | 457 | 457 | ||||||
| Other non-current assets | 5,985 | 6,701 | ||||||
| Property and equipment, net | 1,695 | 1,799 | ||||||
| Total assets | $ | 31,222 | $ | 38,409 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 641 | $ | 1,613 | ||||
| Accrued research and development | 3,487 | 2,825 | ||||||
| Accrued expenses | 3,036 | 3,487 | ||||||
| Due to Ikaria, Inc. | 159 | 148 | ||||||
| Total current liabilities | 7,323 | 8,073 | ||||||
| Total liabilities | 7,323 | 8,073 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity: | ||||||||
| Common stock, $0.01 par value per share; 125,000,000 shares authorized, 13,475,196 and 13,130,800 shares issued and outstanding at March 31, 2016 and December 31, 2015, respectively | 135 | 131 | ||||||
| Preferred stock, $0.01 par value per share; 5,000,000 share authorized, zero shares issued and outstanding at March 31, 2016 and December 31, 2015 | — | — | ||||||
| Additional paid-in capital | 131,499 | 130,902 | ||||||
| Accumulated other comprehensive income (loss) | 2 | (19 | ) | |||||
| Accumulated deficit | (107,737 | ) | (100,678 | ) | ||||
| Total stockholders’ equity | 23,899 | 30,336 | ||||||
| Total liabilities and stockholders’ equity | $ | 31,222 | $ | 38,409 | ||||
Contacts At Bellerophon:Fabian Tenenbaum , Chief Financial Officer (908) 574-4767At Rx Communications Group :Melody Carey (917) 322-2571