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Bellerophon Therapeutics, Inc. (BLPH) SEC Filing 10-Q Quarterly Report for the period ending Wednesday, March 31, 2021

Bellerophon Therapeutics, Inc.

CIK: 1600132 Ticker: BLPH

Exhibit 99.1

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Bellerophon Provides Clinical Program Update and Reports Fourth Quarter and Full-Year 2020 Financial Results

WARREN, N.J., March 11, 2021 – 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 fourth quarter and year ended December 31, 2020.

“Bellerophon continues to make significant progress in advancing its INOpulse® inhaled nitric oxide therapy in multiple indications,” said Fabian Tenenbaum, Chief Executive Officer of Bellerophon. “In December 2020, we announced that the first patient had been enrolled in our pivotal Phase 3 REBUILD study for fibrotic interstitial lung disease (fILD) patients at risk of associated pulmonary hypertension. In addition, we expect top-line results from our Phase 2 dose escalation study of INOpulse in sarcoidosis (PH-Sarc) this year.”

“Our balance sheet continues to be strong and provides us with the resources to support our ongoing clinical programs in fILD and PH-Sarc,” concluded Mr. Tenenbaum.

Clinical Program Highlights:

fILD

REBUILD Phase 3 Study: In December, Bellerophon announced that the first patient had been enrolled in its Phase 3 REBUILD registrational study of INOpulse for the treatment of fILD. The REBUILD study will enroll 300 fILD patients who will be treated with either INOpulse at a dose of iNO45 or placebo. The primary endpoint is change in moderate to vigorous physical activity (MVPA). 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.

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. Acute treatment with INOpulse showed benefit in multiple cardiopulmonary parameters, including pulmonary vascular resistance, which improved by 21%, and mean pulmonary arterial pressure, which improved by 12%. Chronic treatment with INOpulse at a dose of iNO45 assessed over four months showed an average improvement in MVPA of 20% as compared to placebo. The improvements in MVPA were supported by benefits in overall activity, as well as two patient reported questionnaires, the University of California, San Diego Shortness of Breath Questionnaire and the St. George’s Respiratory Questionnaire.

Pulmonary Hypertension-Sarcoidosis (PH-Sarc)

Phase 2 Clinical Study: Bellerophon is continuing enrollment in a Phase 2 dose escalation study in PH-Sarc and anticipates the availability of top-line data during 2021. The safety and efficacy study is assessing the acute hemodynamic benefit of INOpulse via right heart catheterization. PH-Sarc is an unmet medical need with a median survival of approximately five years after diagnosis. Similar to PH associated with fILD, there are currently no approved therapies to treat PH-Sarc.

COVID-19 (Coronavirus)

COViNOX Phase 3 Study: The randomized, placebo-controlled COViNOX study evaluated the efficacy and safety of the investigational INOpulse therapy in patients diagnosed with COVID-19 who require supplemental oxygen. In November 2020, the Company announced the results of a pre-specified interim analysis conducted by

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The following information was filed by Bellerophon Therapeutics, Inc. (BLPH) on Thursday, March 11, 2021 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
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)
Fair Value Measurements (Tables)
Fair Value Measurements - Weighted Average Assumptions (Details)
Income Taxes
Income Taxes (Details)
Liquidity
Liquidity (Details)
Net Loss Per Share
Net Loss Per Share (Details)
Net Loss Per Share - Antidilutive Securities (Details)
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

Ticker: BLPH
CIK: 1600132
Form Type: 10-Q Quarterly Report
Accession Number: 0001558370-21-006763
Submitted to the SEC: Tue May 11 2021 8:30:45 AM EST
Accepted by the SEC: Tue May 11 2021
Period: Wednesday, March 31, 2021
Industry: Pharmaceutical Preparations

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