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Bellerophon Therapeutics, Inc. (BLPH) SEC Filing 10-Q Quarterly report for the period ending Sunday, June 30, 2019

Bellerophon Therapeutics, Inc.

CIK: 1600132 Ticker: BLPH


Exhibit 99.1
blphlogoa53.jpg

Bellerophon Provides Business Update and Reports First Quarter 2019 Financial Results

WARREN, N.J., May 9, 2019
-- Bellerophon Therapeutics, Inc. (Nasdaq: BLPH) (“Bellerophon” or the “Company”), a clinical-stage biotherapeutics company, today provided a business update and reported financial results for the first quarter ended March 31, 2019.

“Bellerophon has achieved substantial progress in the beginning of 2019 with additional important milestones expected later this year,” said Fabian Tenenbaum, Chief Executive Officer of Bellerophon. “We reported positive results from Cohort 1 of our ongoing Phase 2b randomized, double-blind, placebo-controlled clinical study (iNO-PF) of INOpulse® in patients with Pulmonary Hypertension associated with Interstitial Lung Disease (PH-ILD). The study demonstrated a clinically and statistically significant improvement in moderate to vigorous physical activity (MVPA), supporting an agreement with the U.S. Food and Drug Administration (“FDA”) on the regulatory approval pathway for INOpulse in PH-ILD. Importantly, the FDA agreed with our proposal that MVPA will serve as the primary endpoint and that the ongoing Phase 2b study will be amended to a Phase 2/3 trial, providing a seamless transition into Cohort 3, which will serve as the pivotal Phase 3 trial for an efficient development program.”

“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 FDA on the regulatory path forward, we believe INOpulse has the potential to be the first approved drug for this debilitating disease.”

“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 $7 million follow-on offering in January that was anchored by a leading healthcare-focused institutional investor and included significant participation from several members of the Company’s Board of Directors. This financing will allow us to complete Cohort 2 and initiate the pivotal Cohort 3 in PH-ILD, as well as support our planned activities through the readout of the ongoing Phase 2 PH-Sarcoidosis study,” concluded Mr. Tenenbaum.

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).


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The following information was filed by Bellerophon Therapeutics, Inc. (BLPH) on Thursday, May 9, 2019 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Inside Bellerophon Therapeutics, Inc.'s 10-Q Quarterly Report:

Financial Statements, Disclosures and Schedules

Inside this 10-Q Quarterly Report

Document And Entity Information
Condensed Consolidated Balance Sheets
Condensed Consolidated Balance Sheets (Parenthetical)
Condensed Consolidated Statement Of Changes In Stockholders' Equity
Condensed Consolidated Statements Of Cash Flows
Condensed Consolidated Statements Of Comprehensive Loss (Unaudited)
Condensed Consolidated Statements Of Operations
Commitments And Contingencies
Common Stock Warrants And Warrant Liability
Common Stock Warrants And Warrant Liability (Tables)
Common Stock Warrants And Warrant Liability - Narrative (Details)
Common Stock Warrants And Warrant Liability - Warrant Activity (Details)
Fair Value Measurements
Fair Value Measurements (Tables)
Fair Value Measurements - Assumptions Used (Details)
Fair Value Measurements - Fair Value Hierarchy (Details)
Income Taxes
Income Taxes (Details)
Leases
Leases (Details)
Leases (Tables)
Liquidity
Liquidity (Details)
Net Loss Per Share
Net Loss Per Share (Tables)
Net Loss Per Share - Additional Information (Details)
Net Loss Per Share - Calculation (Details)
Organization And Nature Of The Business
Organization And Nature Of The Business (Details)
Stock-Based Compensation
Stock-Based Compensation (Tables)
Stock-Based Compensation - Allocation Of Recognized Period Costs (Details)
Stock-Based Compensation - Narrative (Details)
Stock-Based Compensation - Summary Of Fair Value Of Options Issued (Details)
Stock-Based Compensation - Summary Of Option Activity (Details)
Stock-Based Compensation - Summary Of Restricted Stock Activity (Details)
Summary Of Significant Accounting Policies
Summary Of Significant Accounting Policies (Details)
Summary Of Significant Accounting Policies (Policies)

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Bellerophon Therapeutics, Inc. provided additional information to their SEC Filing as exhibits

Ticker: BLPH
CIK: 1600132
Form Type: 10-Q Quarterly Report
Accession Number: 0001600132-19-000105
Submitted to the SEC: Thu Aug 08 2019 4:31:09 AM EST
Accepted by the SEC: Thu Aug 08 2019
Period: Sunday, June 30, 2019
Industry: Pharmaceutical Preparations

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