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Bellerophon Therapeutics, Inc. (BLPH) SEC Filing 10-Q Quarterly report for the period ending Wednesday, September 30, 2020

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 Second Quarter 2020 Financial Results

WARREN, N.J., August 5, 2020 - Bellerophon Therapeutics, Inc. (Nasdaq: BLPH) (“Bellerophon” or the “Company”), a clinical-stage biotherapeutics company focused on developing treatments for cardiopulmonary and infectious diseases, today provided a clinical program update and reported financial results for the second quarter ended June 30, 2020.

“Bellerophon has achieved significant clinical and regulatory progress advancing our development program for the INOpulse® inhaled nitric oxide therapy,” said Fabian Tenenbaum, Chief Executive Officer of Bellerophon. “We are pleased to have treated the first patient with INOpulse in our COViNOX Phase 3 clinical trial for the treatment of COVID-19 and are excited to work with leading hospitals across the U.S. to enroll patients as expeditiously as possible. The trial initiation follows highly encouraging preliminary data generated from 180 hospitalized COVID-19 patients treated under our recently completed Emergency Expanded Access Program (EAP).”

“Turning to our Pulmonary Fibrosis program, we have recently completed our End-of-Phase 2 meetings with the U.S. Food and Drug Administration (FDA) to align on study design and endpoints and look forward to initiating our pivotal Phase 3 REBUILD trial of INOpulse in Pulmonary Hypertension associated with Pulmonary Fibrosis (PH-PF),” continued Mr. Tenenbaum. “Importantly, results from Cohort 1 of the Phase 2 Study were published in the August 2020 edition of the peer-reviewed CHEST journal and the results from Cohort 2 are being presented at the upcoming American Thoracic Society (ATS) virtual conference.”

“Our strong balance sheet, enhanced by our recently closed $59.0 million from public and registered direct offerings, provides us with the resources necessary to efficiently advance our INOpulse development program and achieve our planned clinical milestones,” concluded Mr. Tenenbaum.

Clinical Program Highlights:

COVID-19 (Coronavirus)

•
COViNOX Phase 3 Study: Bellerophon announced that the first patient has been treated in the Company’s Phase 3 clinical study of INOpulse inhaled nitric oxide (iNO) therapy for the treatment of COVID-19. The Phase 3 randomized, placebo-controlled COViNOX study will evaluate the efficacy and safety of the investigational INOpulse therapy in patients diagnosed with COVID-19 who require supplemental oxygen. The COViNOX protocol utilizes an adaptive design and aims to enroll up to 500 patients with COVID-19 who will be treated with either INOpulse or placebo at major U.S. hospitals. The primary endpoint will assess the proportion of subjects that had respiratory failure or mortality, which should allow the trial to serve as a registrational study for potential approval. Bellerophon has also applied for federal funding, through the Biomedical Advanced Research and Development Authority and the National Institutes of Health, to support the clinical study.

•
Emergency Expanded Access: Under the recently completed EAP, 180 patients at 18 hospitals across the U.S. received treatment with INOpulse for COVID-19 under emergency expanded access granted by the FDA. The program allowed INOpulse to be used for the treatment of

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The following information was filed by Bellerophon Therapeutics, Inc. (BLPH) on Wednesday, August 5, 2020 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 (Tables)
Common Stock Warrants And Warrant Liability - Narrative (Details)
Common Stock Warrants And Warrant Liability - Warrant Activity (Details)
Fair Value Measurements
Fair Value Measurements (Tables)
Fair Value Measurements - Assumptions Used (Details)
Fair Value Measurements - Fair Value Hierarchy (Details)
Income Taxes
Income Taxes (Details)
Liquidity
Liquidity (Details)
Net Loss Per Share
Net Loss Per Share - Additional Information (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)
Stock-Based Compensation
Stock-Based Compensation (Tables)
Stock-Based Compensation - Allocation Of Recognized Period Costs (Details)
Stock-Based Compensation - Narrative (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

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: 0001600132-20-000120
Submitted to the SEC: Thu Nov 05 2020 8:29:05 AM EST
Accepted by the SEC: Thu Nov 05 2020
Period: Wednesday, September 30, 2020
Industry: Pharmaceutical Preparations

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