BELLEROPHON THERPETCS INC - BLPH STOCK NEWS

Bellerophon Therapeutics (Nasdaq: BLPH) has completed enrollment for the INOpulse® REBUILD Phase 3 trial, preparing for top-line data release in mid-2023. Following a license agreement with Baylor BioSciences, the company aims to commercialize INOpulse® in Greater China, receiving a $6 million license fee. Bellerophon also raised $5 million through a registered direct offering to support its ongoing trials. The company reported a net loss of $19.8 million for 2022, a slight increase from the previous year. R&D expenses rose to $16.4 million, while general and administrative costs decreased to $6 million, showcasing initiatives to optimize finances.

Bellerophon Therapeutics, Inc. (Nasdaq: BLPH) announced a registered direct offering to raise approximately $5 million by selling 718,474 shares of common stock at $2.00 each and 1,781,526 prefunded warrants at $1.99 each. The offering, set to close on March 7, 2023, aims to fund the REBUILD Phase 3 study, which evaluates the efficacy of inhaled nitric oxide for patients at risk of pulmonary hypertension. The study has enrolled 145 patients and expects to report topline data in mid-2023.

These shares are offered under an effective shelf registration statement. Investors are advised to review the prospectus for detailed information about the offering.

Bellerophon Therapeutics (Nasdaq: BLPH) has received IND clearance from China's NMPA to conduct a Phase 3 clinical trial for INOpulse® targeting fibrotic interstitial lung disease (fILD). This trial will employ Moderate to Vigorous Physical Activity (MVPA) as the primary endpoint and is in partnership with Baylor BioSciences. CEO Peter Fernandes emphasized the potential of INOpulse to be the first therapy for fILD patients at varying risk levels for pulmonary hypertension, potentially improving their quality of life. This development is a step towards offering a new treatment option in Greater China, catering to an underserved patient population.

Bellerophon Therapeutics (Nasdaq: BLPH) has announced the successful completion of patient enrollment in its pivotal Phase 3 REBUILD study of INOpulse®, aimed at treating fibrotic interstitial lung disease (fILD). This milestone was achieved earlier than expected, with top-line results now anticipated in mid-2023. The REBUILD study involves 145 patients and will evaluate changes in moderate to vigorous physical activity (MVPA) as a primary endpoint. Results will support the submission of a New Drug Application (NDA) for regulatory approval. Further details can be found on ClinicalTrials.gov under Identifier NCT0326710.

Bellerophon Therapeutics has entered into a license agreement with Baylor BioSciences for its INOpulse® product, receiving a $6 million upfront payment and 5% royalties on net sales in Greater China. The agreement allows Baylor to exclusively develop INOpulse for diseases related to pulmonary hypertension, including fibrotic interstitial lung disease. CEO Peter Fernandes expressed optimism about reaching patients in a vast market while enhancing the company's financial position.

Bellerophon Therapeutics (BLPH) announced progress in its Phase 3 REBUILD trial for INOpulse, targeting fibrotic Interstitial Lung Disease (fILD), with enrollment expected to finish in Q1 2023 and top-line data anticipated in Q3 2023.

The study size has been reduced to 140 patients, and maintains over 90% power for its primary endpoint.

For Q3 2022, Bellerophon reported a net loss of $5.1 million, with R&D expenses increasing to $3.8 million. Cash reserves stood at $11.3 million as of September 30, 2022, down from $24.7 million at year-end 2021.

Bellerophon Therapeutics announced FDA acceptance to reduce the study size for its REBUILD Phase 3 trial of INOpulse for treating fibrotic Interstitial Lung Disease from 300 to 140 patients. This change maintains a statistical power of over 90% for the primary endpoint of Moderate to Vigorous Physical Activity (MVPA), ensuring robust trial integrity. Enrollment is expected to wrap up by Q1 2023, with pivotal top-line data anticipated in Q3 2023. The independent Data Monitoring Committee supports this new target, providing a clear path toward accelerated study completion.