“I am pleased to report continued progress in our clinical development programs evaluating INOpulse® to treat pulmonary hypertension in a wide range of unmet chronic diseases,” said
“Importantly, our robust clinical development program is supported by a strong balance sheet, as we ended 2017 with more than
Key Recent Highlights
- PAH: Enrollment in the Phase 3 INOvation-1 study evaluating INOpulse® in patients with PAH now exceeds 100 patients, representing more than half of the anticipated enrollment. As previously agreed with the
U.S. Food and Drug Administration (FDA ), an interim analysis of this study will be performed by the Data Monitoring Committee when half of the subjects complete the 16-week blinded treatment phase. The interim analysis will determine if the study should be stopped early for efficacy or futility, continued as planned, or if the study size should be increased. The Company anticipates the readout of the interim analysis in mid-2018, and the availability of top-line data from the full study around the end of 2018.
- PH-ILD: Following positive results in its Phase 2a study in PH-IPF, Bellerophon has initiated and randomized the first patient in a Phase 2b study evaluating INOpulse to assess the safety and efficacy of pulsed, inhaled nitric oxide (iNO) versus placebo in patients with PH-ILD. A total of 40 subjects will be randomized in the double-blind, placebo-controlled clinical study, including patients with idiopathic pulmonary fibrosis. The primary endpoint of the study is the change in 6 Minute Walk Distance (6MWD) and the study includes several additional endpoints, including improvement in right ventricular function. Top-line results from this study are expected to be available by the end of 2018.
- PH-COPD: Bellerophon recently announced positive results from its Phase 2 study for INOpulse in PH-COPD. The results demonstrated statistically significant and clinically meaningful improvements, as compared to baseline, in 6MWD, as well as systolic pulmonary arterial pressure with 4 weeks of chronic use. The therapy was well tolerated with no related safety concerns. The Company, in conjunction with its steering committee, is planning the next clinical program towards regulatory approval in PH-COPD.
- Financing: In the third quarter of 2017, Bellerophon raised approximately
$23.4 million through a private placement of its common stock and warrants. The financing was led byPuissance Capital Management and Venrock Healthcare Capital Partners , and supported by certain existing investors, includingNew Mountain Capital andLinde North America, Inc.
Fourth Quarter 2017 Financial Results
For the fourth quarter ended December 31, 2017, Bellerophon reported a net loss of
Net loss for the fourth quarter ended December 31, 2017 included an increase in the fair value of the Company’s common stock warrant liability of
Research and development expenses for the fourth quarter of 2017 were
General and administrative expenses for the fourth quarter of 2017 were
Full-Year 2017 Financial Results
For the year ended
Net loss for full-year 2017 included an increase in the fair value of the Company’s common stock warrant liability of
Research and development expenses for the year ended
General and administrative expenses for the year ended
Balance Sheet
As of
As of
About Bellerophon
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
Contacts | |
At Bellerophon: | At LifeSci Advisors: |
Fabian Tenenbaum, Chief Executive Officer | Brian Ritchie |
(908) 574-4767 | (212) 915-2578 |
britchie@lifesciadvisors.com | |
BELLEROPHON THERAPEUTICS, INC. Consolidated Balance Sheets (Amounts in thousands, except share and per share data) |
|||||||
December 31, 2017 |
December 31, 2016 |
||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 28,823 | $ | 14,202 | |||
Restricted cash | 402 | 401 | |||||
Marketable securities | 2,996 | 5,571 | |||||
Prepaid expenses and other current assets | 3,359 | 6,331 | |||||
Total current assets | 35,580 | 26,505 | |||||
Restricted cash, non-current | 150 | 307 | |||||
Other non-current assets | 54 | 1,491 | |||||
Property and equipment, net | 1,026 | 1,399 | |||||
Total assets | $ | 36,810 | $ | 29,702 | |||
Liabilities and Stockholders' Equity (Deficiency in Assets) | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 3,853 | $ | 2,807 | |||
Accrued research and development | 1,785 | 2,573 | |||||
Accrued expenses | 1,441 | 1,115 | |||||
Total current liabilities | 7,079 | 6,495 | |||||
Common stock warrant liability | 32,325 | 5,215 | |||||
Total liabilities | 39,404 | 11,710 | |||||
Commitments and contingencies | |||||||
Stockholders' equity (Deficiency in assets): | |||||||
Common stock, $0.01 par value per share; 125,000,000 shares authorized, 56,899,353 shares issued and outstanding at December 31, 2017, 31,702,624 shares issued and outstanding at December 31, 2016, 289,269 shares paid for and to be issued at December 31, 2017 |
569 | 317 | |||||
Preferred stock, $0.01 par value per share; 5,000,000 shares authorized, zero shares issued and outstanding at December 31, 2017 and 2016 |
— | — | |||||
Additional paid-in capital | 176,151 | 142,167 | |||||
Accumulated other comprehensive loss | (4 | ) | — | ||||
Accumulated deficit | (179,310 | ) | (124,492 | ) | |||
Total stockholders' equity (deficiency in assets) | (2,594 | ) | 17,992 | ||||
Total liabilities and stockholders' equity (deficiency in assets) | $ | 36,810 | $ | 29,702 | |||
Bellerophon Therapeutics, Inc. | ||||||||||||
Consolidated Statement of Operations | ||||||||||||
(in thousands except per share data) | ||||||||||||
Year Ended | Three Months Ended | |||||||||||
December 31, | December 31, | |||||||||||
2017 | 2016 | 2017 | 2016 | |||||||||
Operating expenses: | ||||||||||||
Research and development | $ | 17,854 | $ | 16,650 | $ | 5,390 | $ | 5,111 | ||||
General and administrative | 6,745 | 7,107 | 1,919 | 2,181 | ||||||||
Total operating expenses | 24,599 | 23,757 | 7,309 | 7,292 | ||||||||
Loss from operations | (24,599 | ) | (23,757 | ) | (7,309 | ) | (7,292 | ) | ||||
Change in fair value of common stock warrant liability | (30,403 | ) | (590 | ) | (16,948 | ) | (590 | ) | ||||
Interest and other income, net | 184 | 95 | 98 | 21 | ||||||||
Pre-tax loss | (54,818 | ) | (24,252 | ) | (24,159 | ) | (7,861 | ) | ||||
Income tax benefit | -- | (438 | ) | -- | (438 | ) | ||||||
Net loss | $ | (54,818 | ) | $ | (23,814 | ) | $ | (24,159 | ) | $ | (7,423 | ) |
Weighted average shares outstanding: | ||||||||||||
Basic and diluted | 38,950,937 | 15,057,627 | 55,109,847 | 20,186,996 | ||||||||
Net loss per share: | ||||||||||||
Basic and diluted | $ | (1.41 | ) | $ | (1.58 | ) | $ | (0.44 | ) | $ | (0.37 | ) |