Bellerophon Provides Clinical Program Update and Reports Full-Year 2022 Financial Results
WARREN, N.J., March 31, 2023 (GLOBE NEWSWIRE) -- 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, 2022.
“We have achieved significant recent progress throughout our business, including advancing the INOpulse® clinical program, enhancing our regulatory and commercial prospects in China, and strengthening the balance sheet,” said Peter Fernandes, Bellerophon’s Chief Executive Officer. “With the INOpulse® REBUILD Phase 3 study fully enrolled, we anticipate treating the last patient in the second quarter of 2023, followed by pivotal top-line data readout in mid-2023. Moreover, the recent license agreement established with Baylor BioSciences and the IND clearance from China NMPA to conduct a Phase 3 clinical trial in fibrotic interstitial lung disease (fILD) position us well to access one of the largest commercial markets globally. Importantly, following the license agreement with Baylor and successfully completed $5 million financing, we are now well-capitalized through top-line data from the pivotal Phase 3 REBUILD trial.”
Clinical Program Highlights:
Fibrotic Interstitial Lung Disease (fILD)
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). Based on the benefits demonstrated in hemodynamic parameters and favorable safety profile, Bellerophon designed and submitted to the FDA a proposed exploratory Phase 2 double-blinded placebo-controlled study to investigate the safety and efficacy of iNO45 dosed chronically for six months in patients with PH-Sarc. Subsequently, the Company received FDA clearance to conduct the study and Bellerophon is currently assessing the next steps for the study.
2022 Year-End Financial Results:
For the year ended December 31, 2022, the Company reported a net loss of $19.8 million, or $(2.08) per basic and diluted share, compared to a net loss of $17.8 million, or $(1.87) per basic and diluted share, in the year ended December 31, 2021.
Research and development expenses for the year ended December 31, 2022, were $16.4 million, compared to $13.0 million in the prior year period. The increase was primarily due to the ongoing Phase 3 REBUILD trial.
General and administrative expenses for the year ended December 31, 2022, were $6 million, as compared to $7.1 million in the prior year period. The decrease was primarily due to reduced labor, stock-based compensation, and general consulting costs.
As of December 31, 2022, the Company had unrestricted cash and cash equivalents of $6.9 million, compared to unrestricted cash and cash equivalents of $24.7 million on December 31, 2021. The Company’s capital position as of December 31, 2022 is not reflective of the subsequent transactions which closed in the first quarter of 2023. These transactions include the $1.7 million net proceeds from the sale of Company’s net operating losses and research and development credits under the State of New Jersey’s Technology Business Tax Certificate Transfer Program in January 2023, the $6 million license payment, subject to tax closing costs, due from Baylor BioSciences, and the net proceeds of approximately $5 million from the registered direct offering closed in March 2023.
Bellerophon Therapeutics is a clinical-stage biotherapeutics company focused on developing innovative therapies that address significant unmet medical needs in the treatment of cardiopulmonary diseases. The Company is currently developing multiple product candidates under its INOpulse® program, a proprietary pulsatile nitric oxide delivery system. For more information, please visit www.bellerophon.com.
Any statements in this press release about Bellerophon’s future expectations, plans, and prospects, including statements about the clinical development of its product candidates, regulatory actions with respect to the Company’s clinical trials and expectations regarding the sufficiency of the Company’s cash balance to fund clinical trials, operating expenses and capital expenditures, and other statements containing the words “anticipate,” “believe,” “continue,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: risks and uncertainties relating to INOpulse®, the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary or interim results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials will be indicative of the results of later clinical trials, expectations for regulatory approvals, the FDA’s substantial discretion in the approval process, availability of funding sufficient for our foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the “Risk Factors” section of the Company’s most recent Annual Report on Form 10-K and in subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements included in this press release represent Bellerophon’s views only as of the date of this release and should not be relied upon as representing the Company’s views as of any subsequent date. The Company specifically disclaims any obligation to update any forward-looking statements included in this press release.