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Bellerophon Therapeutics (Nasdaq: BLPH) has appointed Wassim Fares, M.D., as Chief Medical Officer. Dr. Fares brings over 20 years of cardiopulmonary experience, most recently serving as Senior Medical Director at Janssen. His expertise will guide Bellerophon in advancing its INOpulse® programs for Pulmonary Hypertension linked to Pulmonary Fibrosis and COVID-19. The company is progressing its COVID-19 COViNOX Phase 3 trial and preparing to initiate the Phase 3 REBUILD study in PH-PF. This leadership change is poised to strengthen Bellerophon's clinical strategy and development pipeline.
Bellerophon Therapeutics (BLPH) announced positive results from Cohort 1 of the iNO-PF Phase 2/3 Study, indicating that patients treated with INOpulse® showed improved physical activity compared to placebo. The findings, set to be published in the August 2020 edition of the CHEST Journal, confirm the safety and efficacy of the iNO30 dosage for patients at risk of pulmonary hypertension associated with pulmonary fibrosis. Notably, treated patients demonstrated significant increases in moderate to vigorous physical activity (p=0.04) and overall activity (p=0.05). The next Phase 3 trial is being prepared.
Bellerophon Therapeutics (Nasdaq: BLPH) has commenced a Phase 3 clinical study, COViNOX, on its INOpulse® inhaled nitric oxide therapy for COVID-19, initiated at Banner University Medical Center. The study, which aims to enroll up to 500 patients, will assess the therapy's efficacy and safety among patients requiring supplemental oxygen. Preliminary data from an expanded access program indicated a 73% recovery rate and a 6.3% mortality rate among treated patients. The company is pursuing federal funding to support this study.
Bellerophon Therapeutics, Inc. (Nasdaq: BLPH) has been added to the Russell 3000® and Microcap® Indexes as of June 29, 2020. This inclusion follows the annual reconstitution of the Russell indexes, which ranks the largest U.S. stocks based on market capitalization. CEO Fabian Tenenbaum stated that this milestone reflects the company's growth in developing late-stage clinical programs, particularly for INOpulse®, aimed at treating cardiopulmonary and infectious lung diseases. Being part of these indexes enhances visibility among investors, with $9 trillion in assets benchmarked against Russell's indexes.
Bellerophon Therapeutics (Nasdaq: BLPH) has successfully closed a public offering and registered direct offering, securing gross proceeds of approximately $43.7 million. This amount includes the full exercise of the underwriters’ option to purchase additional shares. A total of 3,365,384 shares were issued at a price of $13.00 per share. The company plans to allocate the net proceeds to fund ongoing clinical trials, working capital needs, and general corporate purposes.
Bellerophon Therapeutics, Inc. (Nasdaq: BLPH) announced its intention to conduct an underwritten registered public offering of its common stock. The offering will include a 30-day underwriter option for an additional 15% of shares at the public offering price. Proceeds will be used for ongoing clinical trials, working capital, and general corporate purposes. Jefferies LLC serves as the sole book-running manager for the offering. The offering is subject to market conditions and will be made under an effective shelf registration statement.
Bellerophon Therapeutics (Nasdaq: BLPH) reported a clinical program update and first-quarter financial results for 2020. The FDA has approved a Phase 3 study of INOpulse for COVID-19, following treatment of over 50 patients under emergency access. Positive Phase 2 results for INOpulse in pulmonary hypertension associated with pulmonary fibrosis (PH-PF) were also announced. Financially, the company reported a net loss of $5.0 million or $(1.08) per share, with cash reserves at $8.6 million as of March 31, 2020. A registered direct offering raised $15.3 million in April 2020.
Bellerophon Therapeutics (Nasdaq: BLPH) announced the FDA's acceptance of its IND application to initiate a Phase 3 study for INOpulse® inhaled nitric oxide therapy in COVID-19 patients. This trial, named PULSE-CVD19-001, will involve up to 500 patients requiring supplemental oxygen. The study aims to evaluate the efficacy and safety of INOpulse, with primary endpoints focused on respiratory failure and mortality rates. The company has also secured emergency access for over 50 patients, showing promising improvements. Federal funding applications have been submitted to support the trial.