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Exhibit 99.1
Bellerophon Provides Clinical Program Update and Reports Second Quarter 2021 Financial Results
WARREN, N.J., August 5, 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 second quarter ended June 30, 2021.
“We continue to progress our INOpulse® inhaled nitric oxide therapy in multiple areas of significant unmet need,” said Fabian Tenenbaum, Chief Executive Officer of Bellerophon. “Our ongoing pivotal Phase 3 REBUILD study for fibrotic interstitial lung disease, or fILD, patients at risk of associated pulmonary hypertension is progressing well and continuing to enroll. In addition, we expect top-line results from our Phase 2 dose escalation study of INOpulse in sarcoidosis, or PH-Sarc, later this year. With $34.3 million in cash and cash equivalents, we believe that we are well-positioned financially to continue executing on our promising late-stage clinical 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: 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 no approved therapies, and a median survival of approximately five years after diagnosis. |
Corporate Update:
● | In May 2021, the Company announced the appointment of Naseem Amin, M.D. as Chairman of its Board of Directors. |
● | In May 2021, the Company presented at the Jefferies Virtual Healthcare Conference. |
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Bellerophon Therapeutics, Inc.'s Definitive Proxy Statement (Form DEF 14A) filed after their 2021 10-K Annual Report includes:
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On May 22, 2020, we completed the sale of 3,365,384 shares of our common stock in a public offering and concurrent registered direct offering including a full exercise of an option to purchase additional shares at a price of $13.00 per share, resulting in net proceeds of approximately $40.6 million, after deducting agent fees of $2.9 29 million and offering costs of $0.3 million.
The proceeds from such sales are recorded as income tax benefit when sales occur or proceeds are received.
The proceeds from such sales are recorded as income tax benefit when sales occur or proceeds are received.
The proceeds from such sales are recorded as Income tax benefit when sales occur or proceeds are received.
Total research and development expenses for the three months ended June 30, 2021 were $3.2 million compared to $3.5 million for the three months ended June 30, 2020, a decrease of $0.3 million, or 6%.
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Financial Statements, Disclosures and Schedules
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Bellerophon Therapeutics, Inc. provided additional information to their SEC Filing as exhibits
Ticker: BLPH
CIK: 1600132
Form Type: 10-Q Quarterly Report
Accession Number: 0001558370-21-010416
Submitted to the SEC: Thu Aug 05 2021 8:26:11 AM EST
Accepted by the SEC: Thu Aug 05 2021
Period: Wednesday, June 30, 2021
Industry: Pharmaceutical Preparations