“In the first half of 2019, Bellerophon has achieved substantial clinical and regulatory progress with our INOpulse® pipeline. For our lead program in Pulmonary Hypertension associated with Interstitial Lung Disease (PH-ILD), we presented positive data from Cohort 1 (iNO30) of our ongoing iNO-PF Phase 2/3 study, which demonstrated clinically and statistically significant improvement in moderate to vigorous physical activity (MVPA), further supported by improvements in other important activity and cardiopulmonary parameters,” said
“As we enter the second half of 2019, we look forward to several important catalysts and expect to report top-line results for Cohort 2 by the end of the year. Per the agreement with the
Key Recent Highlights
PH-ILD:
• Cohort 1: Bellerophon presented results from Cohort 1 of iNO-PF, a randomized, double-blind, placebo-controlled clinical study of INOpulse for the treatment of PH-ILD, as a late-breaking abstract oral presentation at the
- MVPA (walking, stairs, yardwork, etc.) improved by 34% (8% increase on iNO vs. 26% decrease on placebo; p=0.04)
-- 23% of subjects on iNO had a clinically significant improvement in MVPA, compared to 0% of subjects on placebo (placebo corrected difference of 23%)
-- 39% of subjects on iNO had a clinically significant decline in MVPA, compared to 71% of subjects on placebo (placebo corrected difference of 32%) - Overall activity improved by 12% (stable on iNO vs. 12% decrease on placebo; p=0.05)
- Calorie expenditure improved by 12% (6% decrease on iNO vs. 18% decrease on placebo; p=0.05)
- Oxygen saturation improved by 20% (9% improvement on iNO vs. 11% deterioration on placebo)
- Subjects on open-label extension demonstrated consistent improvements in MVPA and overall activity, with subjects transitioning from placebo to open-label experiencing a reversal from worsening to improving
• Cohort 2: The Company recently completed recruitment in Cohort 2, which will assess a higher dose (iNO45), as well as a 16-week blinded treatment period. Cohort 2 includes 44 subjects randomized 2:1 to either iNO45 (45 mcg/kg IBW/hr) or placebo. Subjects will complete 16 weeks of blinded treatment on iNO45 vs. placebo, and then continue onto open-label treatment. Bellerophon expects to report top-line results by year-end 2019.
• Cohort 3: Based on the results from Cohort 1, the Company reached agreement with the
PH-Sarcoidosis: Bellerophon has initiated a Phase 2 dose escalation study in PH associated with sarcoidosis. The study is a dose escalation safety and efficacy study that will assess the hemodynamic benefit of INOpulse via right heart catheterization. PH-Sarcoidosis is an unmet medical need with a median survival of approximately five years after diagnosis. Similar to PH-ILD and PH-COPD, PH-Sarcoidosis cannot be treated with currently available systemic vasodilators.
PH-COPD: Following positive results from its Phase 2 study for INOpulse in PH-COPD and agreement with the
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Research and development expenses for the three months ended
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Balance Sheet
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,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “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 Annual Report on Form 10-K and in subsequent filings with the
Contacts
At Bellerophon:
(908) 574-4767
At
(212) 915-2578
britchie@lifesciadvisors.com
BELLEROPHON THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands except share and per share data)
As of | As of | |||||||
June 30, 2019 | December 31, 2018 | |||||||
(Unaudited) | ||||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 16,798 | $ | 16,645 | ||||
Restricted cash | 102 | 101 | ||||||
Prepaid expenses and other current assets | 825 | 650 | ||||||
Total current assets | 17,725 | 17,396 | ||||||
Restricted cash, non-current | 300 | 300 | ||||||
Right of use asset, net | 2,065 | — | ||||||
Property and equipment, net | 488 | 664 | ||||||
Total assets | $ | 20,578 | $ | 18,360 | ||||
Liabilities and Stockholders’ Equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 2,822 | $ | 2,755 | ||||
Accrued research and development | 2,580 | 3,771 | ||||||
Accrued expenses | 752 | 1,013 | ||||||
Current portion of operating lease liability | 556 | — | ||||||
Total current liabilities | 6,710 | 7,539 | ||||||
Long term operating lease liability | $ | 1,739 | $ | — | ||||
Common stock warrant liability | 667 | 6,965 | ||||||
Total liabilities | 9,116 | 14,504 | ||||||
Commitments and contingencies | ||||||||
Stockholders’ equity: | ||||||||
Common stock, $0.01 par value per share; 200,000,000 shares authorized and 68,906,765 and 58,679,492 shares issued and outstanding at June 30, 2019 and December 31, 2018, respectively | 689 | 587 | ||||||
Preferred stock, $0.01 par value per share; 5,000,000 shares authorized, zero shares issued and outstanding at June 30, 2019 and December 31, 2018 | — | — | ||||||
Additional paid-in capital | 192,169 | 179,765 | ||||||
Accumulated deficit | (181,396 | ) | (176,496 | ) | ||||
Total stockholders’ equity | 11,462 | 3,856 | ||||||
Total liabilities and stockholders’ equity | $ | 20,578 | $ | 18,360 | ||||
BELLEROPHON THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
(in thousands except share and per share data)
Three Months Ended June 30, |
Six Months Ended June 30, |
|||||||||||||||
2019 | 2018 | 2019 | 2018 | |||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | $ | 2,629 | $ | 5,815 | $ | 4,934 | $ | 12,195 | ||||||||
General and administrative | 1,596 | 2,058 | 3,633 | 4,170 | ||||||||||||
Total operating expenses | 4,225 | 7,873 | 8,567 | 16,365 | ||||||||||||
Loss from operations | (4,225 | ) | (7,873 | ) | (8,567 | ) | (16,365 | ) | ||||||||
Change in fair value of common stock warrant liability | 673 | (3,689 | ) | 2,289 | 3,361 | |||||||||||
Warrant amendment charge | (674 | ) | — | (674 | ) | — | ||||||||||
Interest and other income, net | 121 | 91 | 251 | 190 | ||||||||||||
Pre-tax loss | (4,105 | ) | (11,471 | ) | (6,701 | ) | (12,814 | ) | ||||||||
Income tax benefit | — | — | 1,801 | 5,439 | ||||||||||||
Net loss | $ | (4,105 | ) | $ | (11,471 | ) | $ | (4,900 | ) | $ | (7,375 | ) | ||||
Weighted average shares outstanding: | ||||||||||||||||
Basic | 68,159,901 | 57,229,259 | 66,683,967 | 57,145,041 | ||||||||||||
Diluted | 68,159,901 | 57,229,259 | 66,683,967 | 66,289,414 | ||||||||||||
Net loss per share: | ||||||||||||||||
Basic | $ | (0.06 | ) | $ | (0.20 | ) | $ | (0.07 | ) | $ | (0.13 | ) | ||||
Diluted | $ | (0.06 | ) | $ | (0.20 | ) | $ | (0.07 | ) | $ | (0.16 | ) |
Source: Bellerophon Therapeutics, Inc.