Bellerophon Provides Business Update and Reports Fourth Quarter and Full-Year 2018 Financial Results

WARREN, N.J., March 14, 2019 (GLOBE NEWSWIRE) -- Bellerophon Therapeutics, Inc. BLPH ("Bellerophon" or the "Company"), a clinical-stage biotherapeutics company, today provided a business update and reported financial results for the fourth quarter and year ended December 31, 2018.

"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 Fabian Tenenbaum, Chief Executive Officer of Bellerophon.  "Subjects on iNO demonstrated statistically significant improvements in multiple clinically meaningful physical activity parameters, as measured by a wearable activity monitor.  In February 2019, we presented on the regulatory precedence of using physical activity as a clinically meaningful endpoint in cardiopulmonary disease at the 13^th Annual Pulmonary Vascular Research Institute World Congress on Pulmonary Vascular Disease.  In addition, we are pleased to have been selected to present additional data from Cohort 1 of iNO-PF in an oral presentation at the upcoming American Thoracic Society Annual Meeting."

"Based on these compelling results, we intend to discuss with the U.S. Food and Drug Administration (FDA) a streamlined regulatory approval path for INOpulse in PH-ILD, a serious condition, for which there is no approved treatment.  In parallel, we will continue with the ongoing Cohorts 2 and 3, which are assessing higher doses of iNO and a longer treatment duration," continued Mr. Tenenbaum. 

"In support of all of our ongoing clinical programs, we recently raised $7 million through a public offering of common stock.  This financing was anchored by a leading healthcare-focused institutional investor and included significant participation from several members of the Company's Board of Directors. We are now well-capitalized through multiple upcoming catalysts over the next 12 months," concluded Mr. Tenenbaum.

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 FDA to 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 million through a public offering of its common stock. The Company's Chairman, Jonathan M. Peacock, and directors Naseem Amin and Ted Wang, each purchased shares in the offering.

Fourth Quarter Ended December 31, 2018 Financial Results

For the fourth quarter ended December 31, 2018, the Company reported a net loss of $0.9 million, or $(0.02) per share, compared to a net loss of $24.2 million, or $(0.44) per share in the fourth quarter ended December 31, 2017. On a diluted basis, the Company reported a loss of $(0.08) per share for the fourth quarter ended December 31, 2018, compared to a loss of $(0.44) per share in the fourth quarter ended December 31, 2017.

Net income for the fourth quarter of 2018 included an adjustment of $3.7 million due to a change in fair value of the Company's common stock warrant liability, as compared to an adjustment of $(16.9) million in the fourth quarter of 2017.

Research and development expenses for the fourth quarter ended December 31, 2018 were $2.8 million, compared to $5.4 million in the prior year period.  The decrease was primarily due to the conclusion of the INOvation-1 PAH trial, which was partially offset by increased activity in the PH-ILD Phase 2b program. 

General and administrative expenses for the fourth quarter ended December 31, 2018 were $1.9 million, essentially flat as compared to the prior year period.

Year Ended December 31, 2018 Financial Results

For the year ended December 31, 2018, the Company reported net income of $2.8 million, or $0.05 per share, compared to a net loss of $54.8 million, or $(1.41) per share, in the year ended December 31, 2017.  On a diluted basis, the Company reported a loss of $(0.34) for the year ended December 31, 2018, compared to a loss of $(1.41) per share in the year ended December 31, 2017.

Net income for the year ended December 31, 2018 included an adjustment of $24.9 million due to a change in fair value of the Company's common stock warrant liability, as compared to an adjustment of $(30.4) million in the year ended December 31, 2017.

Research and development expenses for the year ended of December 31, 2018, were $20.3 million, compared to $17.9 million in the year ended December 31, 2017.  The increase was primarily due to increased clinical trial activities and supply costs related to ongoing clinical programs.

General and administrative expenses for the year ended December 31, 2018, were $7.6 million, compared to $6.7 million in the year ended December 31, 2017. The increase was primarily due to increased commercial, intellectual property and financial consulting expenses, and stock-based compensation expenses.

Balance Sheet

As of December 31, 2018, the Company had cash, cash equivalents and marketable securities of $16.6 million, compared to cash, cash equivalents and marketable securities of $31.8 million at December 31, 2017.  This does not include the $7 million public offering of common stock completed in January 2019, and an additional $1.7 million received in January 2019 from the sale of the Company's tax net operating losses in the State of New Jersey.

About Bellerophon

Bellerophon Therapeutics is a clinical-stage biotherapeutics company focused on developing innovative therapies that address significant unmet medical needs in the treatment of cardiopulmonary diseases. The Company is currently developing multiple product candidates under its INOpulse program, a proprietary pulsatile nitric oxide delivery system.  For more information, please visit www.bellerophon.com.

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 Securities and Exchange Commission. In addition, any forward-looking statements included in this press release represent Bellerophon's views only as of the date of this release and should not be relied upon as representing the Company's views as of any subsequent date. The Company specifically disclaims any obligation to update any forward-looking statements included in this press release.

BELLEROPHON THERAPEUTICS, INC.

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BELLEROPHON THERAPEUTICS, INC.

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