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Bellerophon Therapeutics, Inc. (BLPH) SEC Filing 10-K Annual Report for the fiscal year ending Friday, December 31, 2021

Bellerophon Therapeutics, Inc.

CIK: 1600132 Ticker: BLPH

Exhibit 99.1

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Bellerophon Provides Clinical Program Update and Reports Full-Year 2021 Financial Results

WARREN, N.J., March 31, 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 year ended December 31, 2021.

“The development of our INOpulse® inhaled nitric oxide therapy platform remains our foremost priority, in order to address the significant unmet needs in fibrotic interstitial lung disease, or fILD, and pulmonary hypertension associated with sarcoidosis, or PH-Sarc,” said Naseem Amin, M.D., Chairman of Bellerophon’s Board of Directors. “Late in 2021, we were pleased to report positive top-line results from our Phase 2 proof-of-concept study of INOpulse in PH-Sarc, demonstrating that iNO provided a clinically meaningful reduction in pulmonary vascular resistance. We are working with our steering committee of pulmonary disease experts to assess next steps for our PH-Sarc program, including the design of a follow-up Phase 2b study to evaluate the longer-term benefits of iNO in this disease area. With our fILD program, our pivotal Phase 3 REBUILD study is continuing to enroll and we look forward to providing additional updates on the status of this clinical trial in the coming months. Our balance sheet, with $24.7 million in cash and cash equivalents, provides us with continued resources to advance our late-stage development programs.”

Clinical Program Highlights:

fILD

REBUILD Phase 3 Study: In December 2020, 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 plans to 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: 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

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The following information was filed by Bellerophon Therapeutics, Inc. (BLPH) on Thursday, March 31, 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-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
Consolidated Balance Sheets
Consolidated Balance Sheets (Parenthetical)
Consolidated Statements Of Cash Flows
Consolidated Statements Of Changes In Stockholders' Equity (Deficiency In Assets)
Consolidated Statements Of Operations And Comprehensive Loss
Commitments And Contingencies
Commitments And Contingencies (Details)
Commitments And Contingencies (Tables)
Commitments And Contingencies - Operating Lease Obligations (Details)
Common Stock Warrants
Common Stock Warrants (Details)
Common Stock Warrants (Tables)
Common Stock Warrants - 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)
Income Taxes (Tables)
Income Taxes - Deferred Tax Assets And Liabilities (Details)
Income Taxes - Effective Income Tax Rate (Details)
Income Taxes - Reconciliation Of Statutory Federal Income Tax Rate (Details)
Liquidity And Going Concern
Liquidity And Going Concern (Details)
Net (Loss) Income Per Share (Details)
Net (Loss) Income Per Share (Tables)
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)
Property And Equipment
Property And Equipment (Details)
Property And Equipment (Tables)
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)
Summary Of Significant Accounting Policies - New Accounting Pronouncements (Details)

Material Contracts, Statements, Certifications & more

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

Ticker: BLPH
CIK: 1600132
Form Type: 10-K Annual Report
Accession Number: 0001558370-22-004898
Submitted to the SEC: Thu Mar 31 2022 4:02:56 PM EST
Accepted by the SEC: Thu Mar 31 2022
Period: Friday, December 31, 2021
Industry: Pharmaceutical Preparations

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