“We were extremely pleased with the results from the first cohort of our ongoing Phase 2b placebo-controlled clinical study (iNO-PF) evaluating INOpulse® in patients with Pulmonary Hypertension associated with Interstitial Lung Disease (PH-ILD),” said
“Based on these compelling results, we intend to discuss with the U.S. Food and Drug Administration (
“In support of all of our ongoing clinical programs, we recently raised
Key Recent Highlights
- PH-ILD: The Company announced results from Cohort 1 of the ongoing Phase 2b randomized, double-blind, placebo-controlled 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 multiple parameters, including statistically significant improvements in physical activity, as measured by a wearable activity monitor:
• Minutes of moderate activity (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).
Physical activity data collected in this way is commonly referred to as actigraphy and provides highly sensitive objective real-world data that correlates to a patient’s functional abilities and health outcomes. Physical activity has been correlated to a wide range of clinically meaningful outcomes and the results from Cohort 1 are consistent with other cardiopulmonary studies that have reported clinical significance at a change of 10-20%.
Bellerophon is continuing with Cohorts 2 and 3 in its ongoing Phase 2b study, which will assess higher doses (iNO45 and iNO75), as well as a longer duration of treatment to 16 weeks. The Company has enrolled the first patients in Cohort 2, and continues to see strong recruitment activity and support from clinical sites and KOLs. Top-line data from Cohorts 2 and 3 are anticipated in the second half of 2019. Bellerophon also intends to discuss the results of Cohort 1 with the
FDAto formalize a streamlined regulatory approval pathway for INOpulse in PH-ILD.
- PH-Sarcoidosis: The Company initiated a Phase 2 study to assess the benefits of INOpulse for patients with PH-Sarcoidosis, with results expected later this year. The dose escalation study design allows the hemodynamic benefit of iNO to be assessed via right heart catheterization.
- PH-COPD: Following positive results from its Phase 2 study for INOpulse in PH-COPD and 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. The trial will evaluate multiple endpoints, including change in exercise capacity, right ventricular function and oxygen saturation, as well as other composite endpoints. The Company is currently evaluating next steps for this program.
- Financing: In the first quarter of 2019, Bellerophon raised gross proceeds of
$7 millionthrough a public offering of its common stock. The Company’s Chairman, Jonathan M. Peacock, and directors Naseem Aminand Ted Wang, each purchased shares in the offering.
Fourth Quarter Ended
For the fourth quarter ended
Net income for the fourth quarter of 2018 included an adjustment of
Research and development expenses for the fourth quarter ended
General and administrative expenses for the fourth quarter ended
For the year ended
Net income for the year ended
Research and development expenses for the year ended of
General and administrative expenses for the year ended
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
Fabian Tenenbaum, Chief Executive Officer
|At LifeSci Advisors:
Consolidated Balance Sheets
(Amounts in thousands, except share and per share data)
|December 31, 2018||December 31, 2017|
|Cash and cash equivalents||$||16,645||$||28,823|
|Prepaid expenses and other current assets||650||3,359|
|Total current assets||17,396||35,580|
|Restricted cash, non-current||300||150|
|Other non-current assets||—||54|
|Property and equipment, net||664||1,026|
|Liabilities and Stockholders' Equity (Deficiency in Assets)|
|Accrued research and development||3,771||1,785|
|Total current liabilities||7,539||7,079|
|Common stock warrant liability||6,965||32,325|
|Commitments and contingencies|
|Stockholders' equity (Deficiency in assets):|
|Common stock, $0.01 par value per share; 200,000,000 and 125,000,000 shares authorized and 58,679,492 and 56,899,353 shares issued and outstanding at December 31, 2018 and 2017, respectively, 289,269 shares paid for and to be issued at December 31, 2017||587||569|
|Preferred stock, $0.01 par value per share; 5,000,000 shares authorized, zero shares issued and outstanding at December 31, 2018 and 2017||—||—|
|Additional paid-in capital||179,765||176,151|
|Accumulated other comprehensive loss||—||(4||)|
|Total stockholders' equity (deficiency in assets)||3,856||(2,594||)|
|Total liabilities and stockholders' equity (deficiency in assets)||$||18,360||$||36,810|
Consolidated Statements of Operations
(Amounts in thousands, except share and per share data)
|Research and development||$||20,259||$||17,854||$||16,650|
|General and administrative||7,621||6,745||7,107|
|Total operating expenses||27,880||24,599||23,757|
|Loss from operations||(27,880||)||(24,599||)||(23,757||)|
|Change in fair value of common stock warrant liability||24,877||(30,403||)||(590||)|
|Interest and other income, net||378||184||95|
|Income tax benefit||(5,439||)||—||(438||)|
|Net income (loss)||$||2,814||$||(54,818||)||$||(23,814||)|
|Weighted average shares outstanding:|
|Net income (loss) per share:|
Source: Bellerophon Therapeutics, Inc.