Bellerophon Therapeutics, Inc. (BLPH) SEC Filing 10-Q Quarterly Report for the period ending Friday, June 30, 2023

SEC Filings

BLPH Quarterly Reports

Bellerophon Therapeutics, Inc.

CIK: 1600132 Ticker: BLPH

Exhibit 99.1


Bellerophon Provides Clinical Program Update and Reports First Quarter 2023 Financial Results

-Last Patient Completed Blinded Treatment in REBUILD Phase 3 Trial for INOpulse®; Pivotal Top-line Data Expected in Mid-2023

WARREN, N.J., May 15, 2023 – Bellerophon Therapeutics, Inc. (Nasdaq: BLPH) (“Bellerophon” or the “Company”), a clinical-stage biotherapeutics company focused on developing treatments for cardiopulmonary diseases, today provided a clinical program update and reported financial results for the first quarter ended March 31, 2023.

“We are pleased with the progress we have made to date in 2023, highlighted by the completion of the blinded treatment phase of our ongoing pivotal Phase 3 REBUILD trial,” said Peter Fernandes, Bellerophon’s Chief Executive Officer. “We expect to report top-line results from the study in the middle of this year, a critical milestone for the Company. Importantly, following the recent license agreement with Baylor Bioscience and having successfully completed a $5 million equity financing, we are well-capitalized through this critical milestone.”

Clinical Program Highlights:

Fibrotic Interstitial Lung Disease (fILD)

REBUILD Phase 3 Study: The Company completed the blinded treatment phase of their pivotal Phase 3 REBUILD trial evaluating the safety and efficacy of INOpulse® for the treatment of patients with fILD and anticipates the availability of top-line results in mid-2023. A total of 145 fILD patients were enrolled and treated with either INOpulse at a dose of iNO45 or placebo. The Phase 3 program builds on positive top-line results from the Company’s previously reported Phase 2 studies for INOpulse® for the treatment of fILD which showed benefits in multiple cardiopulmonary parameters, including pulmonary vascular resistance and improvement in Moderate to Vigorous Physical Activity (MVPA) as measured by actigraphy after 16 weeks of chronic treatment. With a total of 145 patients enrolled, the study is powered >90%, (p-value of 0.01) for the primary endpoint of a change in MVPA measured by actigraphy. If approved, INOpulse would become the first therapy to treat a broad fILD population, including patients at low-, intermediate- and high-risk pulmonary hypertension.

Pulmonary Hypertension-Sarcoidosis (PH-Sarc)

Phase 2 Clinical Study: In December 2021, Bellerophon reported positive top-line data from the completed Phase 2 dose escalation study of INOpulse® evaluating the acute hemodynamic benefit of INOpulse® via right heart catheterization for the treatment of pulmonary hypertension associated with sarcoidosis (PH-Sarc). Based on the benefits demonstrated in hemodynamic parameters and favorable safety profile, Bellerophon designed and submitted to the FDA a proposed exploratory Phase 2 double-blinded placebo-controlled study to investigate the safety and efficacy of iNO45 dosed chronically for six months in patients with PH-Sarc. Subsequently, the Company received FDA clearance to conduct the study and Bellerophon is currently assessing the next steps for the study.


The following information was filed by Bellerophon Therapeutics, Inc. (BLPH) on Monday, May 15, 2023 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 Operations And Comprehensive Loss
Commitments And Contingencies
Common Stock Warrants And Warrant Liability
Common Stock Warrants And Warrant Liability (Details)
Common Stock Warrants And Warrant Liability (Tables)
Common Stock Warrants And Warrant Liability - Warrant Activity (Details)
Fair Value Measurements
Fair Value Measurements (Details)
Income Taxes
Income Taxes (Details)
Liquidity (Details)
Net Loss Per Share
Net Loss Per Share (Details)
Net Loss Per Share (Tables)
Net Loss Per Share - Antidilutive Securities (Details)
Organization And Nature Of The Business
Organization And Nature Of The Business (Details)
Revenue (Details)
Right Of Use Assets And Leases
Right Of Use Assets And Leases (Details)
Right Of Use Assets And Leases (Tables)
Right Of Use Assets And Leases - Rou Assets, Lease Liabilities And Maturities (Details)
Stock-Based Compensation
Stock-Based Compensation (Tables)
Stock-Based Compensation - Ikaria Equity Incentive Plans (Details)
Stock-Based Compensation - Incentive Plans (Details)
Stock-Based Compensation - Stock-Based Compensation Expense, Net Of Estimated Forfeitures (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)

Material Contracts, Statements, Certifications & more

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

Ticker: BLPH
CIK: 1600132
Form Type: 10-Q Quarterly Report
Accession Number: 0001558370-23-014867
Submitted to the SEC: Mon Aug 14 2023 4:30:39 PM EST
Accepted by the SEC: Mon Aug 14 2023
Period: Friday, June 30, 2023
Industry: Pharmaceutical Preparations

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