“Bellerophon has achieved substantial progress in the beginning of 2019 with additional important milestones expected later this year,” said
“Cohort 2 will assess a higher dose and longer duration of treatment, allowing us to select the optimal dose to be used in the pivotal Cohort 3. Cohort 2 is enrolling well, reflective of the significant interest from physicians in this study, and we expect to report top-line results and initiate the pivotal Phase 3 trial in the second half of 2019,” continued Mr. Tenenbaum. “PH-ILD represents a significant unmet need as there are currently no approved therapies for this condition which is characterized by progressive and substantial worsening of outcomes such as physical activity, quality of life and life expectancy. Based on the data generated to date and the alignment with the
“We recently initiated our Phase 2 study to assess the effect of iNO in PH-Sarcoidosis, another debilitating condition with no approved therapies. We also successfully completed a
Key Recent Highlights
- PH-ILD: The Company announced positive results from Cohort 1 of its ongoing iNO-PF trial. Cohort 1 included 41 subjects randomized 1:1 to either iNO 30 (30 mcg/kg IBW/hr) or placebo, for a period of 8 weeks of blinded treatment. Subjects on iNO demonstrated improvements in key parameters, including statistically significant improvements in physical activity, as measured by an autonomous wearable activity monitor (actigraphy):
- MVPA (Minutes of moderate to vigorous physical activity, such as walking, stairs, yardwork, etc.) improved by 34% (8% increase on iNO vs. 26% decrease on placebo; p=0.04).
- Overall activity improved by 12% (0% change on iNO vs. 12% decrease on placebo; p=0.05).
- NT-ProBNP improved by 27% (15% increase on iNO vs. 42% increase on placebo). NT-ProBNP is a peptide marker of right ventricular failure, with higher levels indicative of disease worsening.
- Oxygen saturation improved by 20% (9% improvement on iNO vs. 11% deterioration on placebo).
- MVPA (Minutes of moderate to vigorous physical activity, such as walking, stairs, yardwork, etc.) improved by 34% (8% increase on iNO vs. 26% decrease on placebo; p=0.04).
- Based on these results, Bellerophon reached an agreement with the
FDA on the use of MVPA as the primary endpoint in the pivotal Phase 3 study. In addition, theFDA agreed with the Company’s proposal that the ongoing Phase 2b study be amended to a seamless Phase 2/3 trial, allowing Bellerophon to continue directly into the final third cohort required for approval. - Bellerophon is actively recruiting patients in Cohort 2 of its INO-PF trial, which will assess a higher dose (iNO45), as well as a longer duration of treatment to 16 weeks. The Company continues to see strong recruitment activity and support from clinical sites, and top-line data from Cohort 2 are anticipated in the second half of 2019. Bellerophon also expects to initiate Cohort 3 in the second half of 2019.
- PH-Sarcoidosis: Bellerophon has initiated a Phase 2 dose escalation study that will assess safety, as well as the hemodynamic benefit of iNO via right heart catheterization in subjects with PH associated with Sarcoidosis. 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. Top-line results from the study are expected later this year.
- PH-COPD: Following positive results from its Phase 2 study for INOpulse in PH-COPD and an agreement with the
FDA , Bellerophon finalized the design of a Phase 2b study in PH-COPD. This trial will be a randomized, double-blind, placebo-controlled study that will evaluate multiple clinically relevant endpoints.
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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: Fabian Tenenbaum, Chief Executive Officer (908) 574-4767 |
At LifeSci Advisors: Brian Ritchie (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 | |||||||
March 31, 2019 | December 31, 2018 | |||||||
(Unaudited) | ||||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 20,679 | $ | 16,645 | ||||
Restricted cash | 101 | 101 | ||||||
Prepaid expenses and other current assets | 948 | 650 | ||||||
Total current assets | 21,728 | 17,396 | ||||||
Restricted cash, non-current | 300 | 300 | ||||||
Right of use asset, net | 2,189 | — | ||||||
Property and equipment, net | 576 | 664 | ||||||
Total assets | $ | 24,793 | $ | 18,360 | ||||
Liabilities and Stockholders’ Equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 2,638 | $ | 2,755 | ||||
Accrued research and development | 3,187 | 3,771 | ||||||
Accrued expenses | 885 | 1,013 | ||||||
Current portion of operating lease liability | 547 | — | ||||||
Total current liabilities | 7,257 | 7,539 | ||||||
Long term operating lease liability | $ | 1,882 | $ | — | ||||
Common stock warrant liability | 5,349 | 6,965 | ||||||
Total liabilities | 14,488 | 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 March 31, 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 March 31, 2019 and December 31, 2018 | — | — | ||||||
Additional paid-in capital | 186,907 | 179,765 | ||||||
Accumulated deficit | (177,291 | ) | (176,496 | ) | ||||
Total stockholders’ equity | 10,305 | 3,856 | ||||||
Total liabilities and stockholders’ equity | $ | 24,793 | $ | 18,360 |
BELLEROPHON THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
(in thousands except share and per share data)
Three Months Ended March 31, |
||||||||
2019 | 2018 | |||||||
Operating expenses: | ||||||||
Research and development | $ | 2,305 | $ | 6,380 | ||||
General and administrative | 2,037 | 2,112 | ||||||
Total operating expenses | 4,342 | 8,492 | ||||||
Loss from operations | (4,342 | ) | (8,492 | ) | ||||
Change in fair value of common stock warrant liability | 1,616 | 7,050 | ||||||
Interest and other income, net | 130 | 99 | ||||||
Pre-tax loss | (2,596 | ) | (1,343 | ) | ||||
Income tax benefit | 1,801 | 5,439 | ||||||
Net (loss) income | $ | (795 | ) | $ | 4,096 | |||
Weighted average shares outstanding: | ||||||||
Basic | 65,191,635 | 57,059,686 | ||||||
Diluted | 65,191,635 | 72,100,690 | ||||||
Net (loss) income per share: | ||||||||
Basic | $ | (0.01 | ) | $ | 0.07 | |||
Diluted | $ | (0.01 | ) | $ | (0.04 | ) |
Source: Bellerophon Therapeutics, Inc.