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Bellerophon Therapeutics, Inc. (BLPH) SEC Filing 10-K Annual report for the fiscal year ending Saturday, December 31, 2016

Bellerophon Therapeutics, Inc.

HISTORY TOOLS
CIK: 1600132 Ticker: BLPH


Exhibit 99.1
blphlogoa10.jpg

Bellerophon Reports Fourth Quarter 2016 Financial Results
and Provides Business Update

Warren, NJ, March 13, 2017 -
Bellerophon Therapeutics, Inc. (Nasdaq: BLPH), a clinical-stage biotherapeutics company, today provided a business update and reported financial results for the fourth quarter and full year ended December 31, 2016.

“I am pleased with the progress in our ongoing clinical programs to treat pulmonary hypertension in unmet or under-served chronic pulmonary disease areas,” stated Fabian Tenenbaum, Chief Executive Officer of Bellerophon Therapeutics. “Importantly, we are delighted by the FDA’s recent agreement with the proposed acceleration of our PAH Phase 3 program, which has the potential to make the INOpulse® therapy available to PAH patients approximately two years earlier than otherwise would have been possible under the original Phase 3 program. This is positive news for the many patients who continue to suffer from poor outcomes with currently available treatments for PAH.”

“Moreover, we expect to communicate the results of our Phase 2 trials for INOpulse therapy to treat significant unmet needs in pulmonary hypertension (PH) associated with chronic obstructive pulmonary disease (PH-COPD) and idiopathic pulmonary fibrosis (PH-IPF) during the middle of 2017”, added Mr. Tenenbaum. “Our clinical and operational progress has been complemented by strengthening our balance sheet with the completion of an equity financing last November.”

 Key Highlights for 2016 and Business Update:

•
The Company announced positive data in February from the final analysis of its Phase 2 long-term extension study of INOpulse for the treatment of Pulmonary Arterial Hypertension (PAH). This data demonstrated a sustained benefit and a favorable safety profile for long-term oxygen therapy patients who received the higher iNO 75 dose and stayed on the therapy for at least 12 hours a day.

•
The U.S. Food and Drug Administration (FDA) accepted modifications proposed by the Company to its Phase 3 program for INOpulse in the treatment of PAH. Under the newly modified accelerated Phase 3 program the INOvation-1 study, together with a second confirmatory randomized withdrawal study can serve as the two adequate and well-controlled studies to support a New Drug Application (NDA) filing for INOpulse in PAH. The randomized withdrawal study will recruit approximately 40 patients directly from the INOvation-1 study, thereby eliminating the need for recruiting additional patients. The accelerated program eliminates the need for a second standalone Phase 3 study resulting in significant reduction in overall cost and development time, including reducing the total planned patient enrollment from 470 subjects to 188 subjects.

•
The Company initiated its Phase 3 PAH study, INOvation-1, incorporating the smaller and lighter next generation INOpulse device. Enrollment continues in INOvation-1, with topline results targeted in mid-2018 and an interim read expected around the end of 2017.


1
The following information was filed by Bellerophon Therapeutics, Inc. (BLPH) on Monday, March 13, 2017 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.

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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 (tables)
Commitments And Contingencies - Narrative
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
Liquidity (details)
Marketable Securities
Marketable Securities (available-for-sale Securities)
Marketable Securities (details)
Marketable Securities (tables)
Net Loss Per Share/unit
Net Loss Per Share/unit - Narrative
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 (service Agreement) (details)
Related-party Transactions (tables)
Related-party Transactions - Narrative
Restructuring Charges
Restructuring Charges (details)
Restructuring Charges (tables)
Restructuring Charges - Narrative (details)
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 (policies)
Summary Of Significant Accounting Policies - Narrative (details)
Warrants
Warrants (details)
Warrants (tables)

Material Contracts, Statements, Certifications & more

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

Exhibit 23.1: Consents Of Experts And Counsel
Exhibit 31.1: Rule 13A-14(A)/15D-14(A) Certification
Exhibit 31.2: Rule 13A-14(A)/15D-14(A) Certification
Exhibit 32: Section 1350 Certification
Ticker: BLPH
CIK: 1600132
Form Type: 10-K Annual Report
Accession Number: 0001600132-17-000006
Submitted to the SEC: Mon Mar 13 2017 6:17:58 AM EST
Accepted by the SEC: Mon Mar 13 2017
Period: Saturday, December 31, 2016
Industry: Pharmaceutical Preparations

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