“Overall progress in our ongoing clinical programs has been encouraging and I am pleased with data recently reported in both PAH and in pulmonary hypertension associated with idiopathic pulmonary fibrosis (PH-IPF). We look forward to the presentation of the Phase 2 PH-IPF study at the American Thoracic Society (ATS)
“We were encouraged with the results of the recent investigator-initiated study of patients with PAH, which suggested that pulsed inhaled nitric oxide, as delivered by our INOpulse device, may have an important role in blunting pulmonary pressures both with and without exercise in PAH,” added Mr. Tenenbaum. “Bellerophon’s progress toward our clinical and regulatory goals is positive news for the many patients who continue to suffer from poor outcomes with currently available treatments for PAH or with unmet medical needs in PH-IPF and PH-COPD.”
Key Highlights for the First Quarter of 2017 and Business Update:
•
• The Company’s Phase 3 PAH study, INOvation-1, continues to progress with approximately 90 clinical sites initiated in 14 countries. An interim read-out of the Phase 3 PAH trial is planned when 16-week data is available on 75 patients, which is targeted around the end of 2017 and topline results are targeted in mid-2018.
• Clinical data from an investigator-initiated study of INOpulse in patients with PAH were featured in a poster presentation at the International Society for Heart and Lung Transplantation (ISHLT) on April 6th. According to investigators, the study reinforced existing knowledge and provided real world information that suggests pulsed inhaled nitric oxide, as delivered by the iNO pulse device, may have an important role in blunting pulmonary pressures both with and without exercise in PAH.
• The company announced that it will present new clinical data from its Phase 2 study evaluating the use of INOpulse in idiopathic pulmonary fibrosis patients with pulmonary hypertension (PH-IPF) at the American Thoracic Society (ATS)
- Clinically important improvements seen acutely and at 4 weeks in both hemodynamics and exercise capacity in all patients.
- Hemodynamics, as determined by reduction in systolic pulmonary arterial pressure (sPAP), showed improvement in all patients with an average reduction of 14% compared to baseline.
- Dose titration suggested that the iNO 30 dose can safely provide clinically relevant reduction in sPAP.
- The 6-minute walk distance increased on average 75 meters from baseline after 4 weeks of chronic use of INOpulse therapy.
- Improved oxygenation during the 6 minute walk test provides supportive evidence of targeted vasodilation and improved ventilation and perfusion (V/Q) matching.
- Detailed study data, including for the composite endpoints and respiratory imaging, will be presented in the poster at the ATS meeting. The next step in this clinical program will be to conduct a larger, controlled Phase 2b study to inform the design of a pivotal Phase 3 trial.
• Continued progress on the company’s Phase 2 chronic treatment trial for the INOpulse therapy to treat pulmonary hypertension associated with chronic obstructive pulmonary disease, or PH-COPD, to evaluate the potential benefit of chronic treatment. This study follows positive results from the Company’s Phase 2a study and proof-of-mechanism work in PH-COPD. The results of this trial are expected in mid-2017.
• Subsequent to the end of the first quarter, on
First Quarter 2017 Financial Results
For the first quarter ended
Research and development expenses for the first quarter of 2017 were
General and administrative expenses for the first quarter of 2017 were $1.4 million, a decrease of 27 percent from $2.0 million in the first quarter of 2016, primarily due to reduction in personnel costs, including franchise taxes and consulting costs.
Net loss for the first quarter of 2017 included a change in fair value of common stock warrant liability of
Net loss per share was
At
As of
The Company believes that as of
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 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.
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. | ||||||||||
| Consolidated Balance Sheet | ||||||||||
| (unaudited, in thousands except share and per share data) | ||||||||||
| March 31, 2017 | December 31, 2016 | |||||||||
| Assets | ||||||||||
| Current assets: | ||||||||||
| Cash and cash equivalents | $ | 13,539 | $ | 14,453 | ||||||
| Restricted cash | 150 | 150 | ||||||||
| Marketable securities | 3,113 | 5,571 | ||||||||
| Prepaid expenses and other current assets | 6,442 | 6,331 | ||||||||
| Total current assets | 23,244 | 26,505 | ||||||||
| Restricted cash, non-current | 307 | 307 | ||||||||
| Other non-current assets | 909 | 1,491 | ||||||||
| Property and equipment, net | 1,300 | 1,399 | ||||||||
| Total assets | $ | 25,760 | $ | 29,702 | ||||||
| Liabilities and Stockholders' Equity | ||||||||||
| Current liabilities: | ||||||||||
| Accounts payable | $ | 3,944 | $ | 2,807 | ||||||
| Accrued research and development | 1,183 | 2,573 | ||||||||
| Accrued expenses | 717 | 922 | ||||||||
| Due to Ikaria, Inc. | 216 | 193 | ||||||||
| Total current liabilities | 6,060 | 6,495 | ||||||||
| Common stock warrant liability | 18,900 | 5,215 | ||||||||
| Total liabilities | 24,960 | 11,710 | ||||||||
| Commitments and contingencies | ||||||||||
| Stockholders’ equity: | ||||||||||
| Common stock, $0.01 par value per share; 125,000,000 shares authorized, 32,988,683 and 31,702,624 shares issued and outstanding at March 31, 2017 and December 31, 2016, respectively | 330 | 317 | ||||||||
| Preferred stock, $0.01 par value per share; 5,000,000 share authorized, zero shares issued and outstanding at March 31, 2017 and December 31, 2016 | - | - | ||||||||
| Additional paid-in capital | 144,105 | 142,167 | ||||||||
| Accumulated other comprehensive income (loss) | - | - | ||||||||
| Accumulated deficit | (143,635 | ) | (124,492 | ) | ||||||
| Total stockholders’ equity | 800 | 17,992 | ||||||||
| Total liabilities and stockholders' equity | $ | 25,760 | $ | 29,702 | ||||||
| BELLEROPHON THERAPEUTICS INC. | ||||||||
| CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||
| (unaudited, in thousands except share and per share data) | ||||||||
| Quarter Ended March 31, | ||||||||
| 2017 | 2016 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 3,337 | $ | 5,113 | ||||
| General and administrative | 1,446 | 1,976 | ||||||
| Total operating expenses | 4,783 | 7,089 | ||||||
| Loss from operations | (4,783 | ) | (7,089 | ) | ||||
| Change in fair value of common stock warrant liability | (14,387 | ) | - | |||||
| Interest income | 27 | 30 | ||||||
| Loss before taxes | (19,143 | ) | (7,059 | ) | ||||
| Income tax benefit | - | - | ||||||
| Net loss | $ | (19,143 | ) | $ | (7,059 | ) | ||
| Weighted average shares outstanding: | ||||||||
| Basic and diluted | 31,934,253 | 13,053,007 | ||||||
| Net loss per share: | ||||||||
| Basic and diluted | $ | (0.60 | ) | $ | (0.54 | ) | ||
At Bellerophon:Fabian Tenenbaum , Chief Financial Officer (908) 574-4767At LifeSci Advisors :Bob Yedid (646) 597-6989 bob@lifesciadvisors.com