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Bellerophon Therapeutics, Inc. (BLPH) SEC Filing 10-Q Quarterly Report for the period ending Friday, September 30, 2022

Bellerophon Therapeutics, Inc.

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CIK: 1600132 Ticker: BLPH

Exhibit 99.1

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Bellerophon Provides Clinical Program Update and Reports Third Quarter 2022 Financial Results

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-Ongoing INOpulse® REBUILD Phase 3 trial enrollment completion expected in the first quarter of 2023, with pivotal top-line data readout anticipated in the third quarter of 2023

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WARREN, N.J., November 14, 2022 – 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 third quarter ended September 30, 2022.

“We continue to achieve important progress in advancing the ongoing REBUILD Phase 3 trial of INOpulse® for the treatment of fibrotic Interstitial Lung Disease (fILD),” said Naseem Amin, M.D., Chairman of Bellerophon’s Board of Directors.

“With the recent U.S. Food and Drug Administration (FDA) acceptance of the reduction in the study sample size, we are well positioned to accelerate the completion of the REBUILD study, which is now approximately 85% enrolled. We expect that enrollment will conclude in the first quarter of 2023, with the reporting of pivotal top-line data in third quarter of 2023,” said Peter Fernandes, Bellerophon’s Principal Executive Officer.

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Clinical Program Highlights:

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Fibrotic Interstitial Lung Disease (fILD)

●REBUILD Phase 3 Study: Phase 3 REBUILD registrational study enrollment of INOpulse for the treatment of fILD is approaching completion. The reduced study size is 140 fILD patients who will be treated with either INOpulse at a dose of iNO45 or a placebo. The new study size does not impact the trial’s principal objective or endpoints and maintains power of >90% (p-value < 0.01) for the primary endpoint of Moderate to Vigorous Physical Activity (MVPA) based on the effect size observed in Phase 2. If approved, INOpulse would become the first therapy to treat a broad fILD population that includes patients at low-, intermediate- and high-risk of pulmonary hypertension. Following the evaluation of baseline MVPA characteristics, as measured by actigraphy, compliance to treatment, and review of safety data of randomized subjects in the ongoing Phase 3 REBUILD study, the trial’s independent Data Monitoring Committee (DMC) supported reducing the target study size from 300 to 140 subjects.

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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 MVPA.

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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). PH-Sarc is an unmet medical need with no approved therapies and a median survival of approximately five years after diagnosis. The Phase 2 trial was designed as a proof-of-concept study to determine if iNO could demonstrate hemodynamic benefit in PH-Sarc.

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The following information was filed by Bellerophon Therapeutics, Inc. (BLPH) on Monday, November 14, 2022 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 (Details)
Common Stock Warrants - Warrant Activity (Details)
Common Stock Warrants And Warrant Liability
Common Stock Warrants And Warrant Liability (Tables)
Fair Value Measurements (Details)
Fair Value Measurements (Tables)
Fair Value Measurements - Weighted Average Assumptions (Details)
Income Taxes
Income Taxes (Details)
Liquidity
Liquidity (Details)
Net (Loss) Income Per Share (Details)
Net (Loss) Income Per Share - Antidilutive Securities (Details)
Net Loss Per Share
Organization And Nature Of The Business
Organization And Nature Of The Business (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 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

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-Q Quarterly Report
Accession Number: 0001558370-22-017610
Submitted to the SEC: Mon Nov 14 2022 8:53:52 AM EST
Accepted by the SEC: Mon Nov 14 2022
Period: Friday, September 30, 2022
Industry: Pharmaceutical Preparations

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