- Last Patient Completed Blinded Treatment in REBUILD Phase 3 Trial for INOpulse®; Pivotal Top-line Data Expected in Mid-2023
“We are pleased with the progress we have made to date in 2023, highlighted by the completion of the blinded treatment phase of our ongoing pivotal Phase 3 REBUILD trial,” said
Clinical Program Highlights:
Fibrotic Interstitial Lung Disease (fILD)
- REBUILD Phase 3 Study: The Company completed the blinded treatment phase of their pivotal Phase 3 REBUILD trial evaluating the safety and efficacy of INOpulse® for the treatment of patients with fILD and anticipates the availability of top-line results in mid-2023. A total of 145 fILD patients were enrolled and treated with either INOpulse at a dose of iNO45 or placebo. The Phase 3 program builds on positive top-line results from the Company’s previously reported Phase 2 studies for INOpulse® for the treatment of fILD which showed benefits in multiple cardiopulmonary parameters, including pulmonary vascular resistance and improvement in Moderate to Vigorous Physical Activity (MVPA) as measured by actigraphy after 16 weeks of chronic treatment. With a total of 145 patients enrolled, the study is powered >90%, (p-value of 0.01) for the primary endpoint of a change in MVPA measured by actigraphy. If approved, INOpulse would become the first therapy to treat a broad fILD population, including patients at low-, intermediate- and high-risk pulmonary hypertension.
Pulmonary Hypertension-Sarcoidosis (PH-Sarc)
Phase 2 Clinical Study: In
First Quarter Ended
Total licensing revenue for the three months ended
For the first quarter ended
Research and development expenses for the first quarter ended
General and administrative expenses for the first quarter ended
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: risks and uncertainties relating to INOpulse®, 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
(212) 915-2578
britchie@lifesciadvisors.com
BELLEROPHON THERAPEUTICS, INC. Consolidated Balance Sheets (Amounts in thousands, except share and per share data) |
|||||||
As of | As of | ||||||
(Unaudited) | |||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 15,172 | $ | 6,924 | |||
Restricted cash | 405 | 405 | |||||
Prepaid expenses and other current assets | 194 | 234 | |||||
Total current assets | 15,771 | 7,563 | |||||
Right of use assets, net | 8 | 184 | |||||
Property and equipment, net | 1 | 2 | |||||
Other non-current assets | 186 | 186 | |||||
Total assets | $ | 15,966 | $ | 7,935 | |||
Liabilities and Stockholders' Equity | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 1,070 | $ | 1,230 | |||
Accrued research and development | 2,858 | 2,655 | |||||
Accrued expenses | 1,428 | 1,313 | |||||
Current portion of operating lease liabilities | 8 | 203 | |||||
Total liabilities | 5,364 | 5,401 | |||||
Commitments and contingencies | |||||||
Stockholders' equity: | |||||||
Common stock, |
104 | 96 | |||||
Preferred stock, |
— | — | |||||
Additional paid-in capital | 259,754 | 254,516 | |||||
Accumulated deficit | (249,256 | ) | (252,078 | ) | |||
Total stockholders' equity | 10,602 | 2,534 | |||||
Total liabilities and stockholders' equity | $ | 15,966 | $ | 7,935 |
BELLEROPHON THERAPEUTICS, INC. Consolidated Statements of Operations And Comprehensive Income (Loss) (Amounts in thousands, except share and per share data) |
|||||||
Three Months Ended | |||||||
2023 | 2022 | ||||||
Revenues: | |||||||
Licensing revenue | $ | 5,640 | $ | — | |||
Operating expenses: | |||||||
Research and development | 2,552 | 4,409 | |||||
General and administrative | 1,609 | 1,233 | |||||
Total operating expenses | 4,161 | 5,642 | |||||
Income (loss) from operations | 1,479 | (5,642 | ) | ||||
Interest income | 66 | 1 | |||||
Pre-tax income (loss) | 1,545 | (5,641 | ) | ||||
Income tax benefit | 1,277 | — | |||||
Net income (loss) and comprehensive income (loss) | $ | 2,822 | $ | (5,641 | ) | ||
Weighted average shares outstanding: | |||||||
Basic | 10,358,111 | 9,545,451 | |||||
Diluted | 10,605,946 | 9,545,451 | |||||
Net income (loss) per share: | |||||||
Basic | $ | 0.27 | $ | (0.59 | ) | ||
Diluted | $ | 0.27 | $ | (0.59 | ) |

Source: Bellerophon Therapeutics, Inc.