Bellerophon Therapeutics, Inc. (BLPH) SEC Filing 10-K Annual report for the fiscal year ending Thursday, December 31, 2015

Bellerophon Therapeutics, Inc.

CIK: 1600132 Ticker: BLPH

Exhibit 99.1

Bellerophon Reports 2015 Financial Results and Provides Business Update

- Company Receives Final FDA Confirmation to Initiate Phase 3 Studies Using Next Generation INOpulse Device -

- Management to Host a Conference Call Today at 8:30 a.m. ET -

 Warren, NJ, March 21, 2016 -
Bellerophon Therapeutics, Inc. (Nasdaq: BLPH), a clinical-stage biotherapeutics company, today reported financial results for the year ended December 31, 2015 and provided a business update.

Jonathan Peacock, Chairman and Chief Executive Officer of Bellerophon Therapeutics, stated, “2015 was an important transitional year for us. Today, we are well positioned with a strong leadership team and the resources available to complete the first of two Phase 3 clinical trials for patients suffering from Pulmonary Arterial Hypertension, or PAH, in addition to planned Phase 2 studies in Pulmonary Hypertension associated with COPD and Pulmonary Fibrosis. I am pleased to report that we now have final agreement to start enrolling patients in our PAH Phase 3 program under a Special Protocol Assessment (SPA) with the FDA using our new lighter INOpulse device. This completes and consolidates our agreements with both the FDA and the European Medicines Agency on a global Phase 3 clinical program that we plan to conduct in approximately 22 countries. We are currently preparing to enroll patients in the first of the two planned Phase 3 trials.

“Overall, we have an ambitious clinical schedule for 2016 and by combining nitric oxide, a well understood therapy with our innovative INOpulse® delivery system, we look forward to advancing each of our programs to deliver much needed treatments for these serious chronic diseases,” concluded Mr. Peacock.

Key Highlights from 2015 and Subsequent Weeks, Include:

Positive data from the long-term extension study of Bellerophon’s PAH Phase 2 study, demonstrating a sustained benefit and a clean safety profile for patients on long-term oxygen therapy who received the higher INO 75 dose and who stayed on the therapy for at least 12 hours a day.

Receipt of final confirmation from FDA that the Phase 3 studies can commence under a Special Protocol Assessment, or SPA agreement. The Phase 3 program will utilize Bellerophon’s new lighter 2.5 pound INOpulse device. The Company expects to complete the first Phase 3 study in the first half of 2018.

Agreement with the European Medicines Agency on the Phase 3 trial protocol and receipt of CE Mark approval for the new INOpulse device, clearing the way for enrollment of patients in Europe for the Phase 3 study.

First shipment of the new INOpulse device to Bellerophon’s distribution center in the United States. The Company expects the new device to be in use by patients who are participating in the Phase 2 continuation program by the end of the first quarter and shortly after by patients enrolling in the Phase 3 program.

Advancement of plans for further Phase 2 study testing in the second quarter of 2016 to demonstrate the potential benefit of INOpulse on exercise capacity for patients suffering from Pulmonary Hypertension associated with chronic obstructive pulmonary disease, or PH-COPD. This follows results from the Company’s Phase 2a study and proof of mechanism work, showing that in an acute setting, the Company’s pulsed nitric oxide safely reduces PH for COPD patients and increases blood volume in the vessels within the lung.

The following information was filed by Bellerophon Therapeutics, Inc. (BLPH) on Monday, March 21, 2016 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-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

View differences made from one year to another to evaluate Bellerophon Therapeutics, Inc.'s financial trajectory

Compare SEC Filings Year-over-Year (YoY) and Quarter-over-Quarter (QoQ)
Sample 10-K Year-over-Year (YoY) Comparison

Compare this 10-K Annual Report to its predecessor by reading our highlights to see what text and tables were  removed  ,   added    and   changed   by Bellerophon Therapeutics, Inc..


Assess how Bellerophon Therapeutics, Inc.'s management team is paid from their Annual Proxy

Definitive Proxy Statement (Form DEF 14A)
Screenshot example of actual Proxy Statement

Bellerophon Therapeutics, Inc.'s Definitive Proxy Statement (Form DEF 14A) filed after their 2016 10-K Annual Report includes:

  • Voting Procedures
  • Board Members
  • Executive Team
  • Salaries, Bonuses, Perks
  • Peers / Competitors


SEC Filing Tools


Learn More
Bullish Bearish Neutral
Filter Sentiment:
Filter Category:
Filter Subcategory:
Inside Bellerophon Therapeutics, Inc.'s 10-K Annual Report:

Financial Statements, Disclosures and Schedules

Inside this 10-K Annual Report

Document And Entity Information
Condensed Consolidated Statements Of Changes In Stockholders'/members Equity (parenthetical)
Consolidated Balance Sheets
Consolidated Balance Sheets (parenthetical)
Consolidated Statements Of Cash Flows
Consolidated Statements Of Changes In Stockholders'/members Equity
Consolidated Statements Of Comprehensive Loss
Consolidated Statements Of Operations
Commitments And Contingencies
Commitments And Contingencies (details)
Commitments And Contingencies (tables)
Commitments And Contingencies - Summary Of Operating Lease Obligations (details)
Fair Value Measurements
Fair Value Measurements (details)
Fair Value Measurements (tables)
Income Taxes
Income Taxes (details Textual)
Income Taxes (reconciliation Of Effective Income Tax Rate) (details)
Income Taxes (significant Components Of Deferred Tax Assets & Liabilities) (details)
Income Taxes (tables)
Liquidity (details)
Marketable Securities
Marketable Securities (details 2)
Marketable Securities (details)
Marketable Securities (tables)
Marketable Securities - Narrative (details)
Net Loss Per Share/unit
Net Loss Per Share/unit (details)
Organization And Nature Of The Business
Organization And Nature Of The Business (details)
Property And Equipment
Property And Equipment (details)
Property And Equipment (tables)
Quarterly Financial Data (unaudited)
Quarterly Financial Data (unaudited) (details)
Quarterly Financial Data (unaudited) (tables)
Related-party Transactions
Related-party Transactions (details 2)
Related-party Transactions (details)
Related-party Transactions (tables)
Restructuring Charges
Restructuring Charges (details)
Restructuring Charges (tables)
Stock-based Compensation
Stock-based Compensation (details Textual)
Stock-based Compensation (schedule Of Employee Service Share-based Compensation, Allocation Of Recognized Period Costs) (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)
Stock-based Compensation (tables)
Summary Of Significant Accounting Policies
Summary Of Significant Accounting Policies (details 2)
Summary Of Significant Accounting Policies (details)
Summary Of Significant Accounting Policies (policies)
Ticker: BLPH
CIK: 1600132
Form Type: 10-K Annual Report
Accession Number: 0001600132-16-000025
Submitted to the SEC: Mon Mar 21 2016 4:07:51 PM EST
Accepted by the SEC: Mon Mar 21 2016
Period: Thursday, December 31, 2015
Industry: Pharmaceutical Preparations

External Resources:
Stock Quote
Social Media

Bookmark the Permalink: