Bellerophon provides clinical services – GuruFocus.com
WARREN, NJ, May 11, 2022 (GLOBE NEWSWIRE) — Bellerophon Therapeutics, Inc. (BLPH) (“Bellerophon” or the “Company”), a clinical-stage biotherapeutics company focused on developing treatments for cardiovascular diseases. Pulmonary Diseases, today provided an update of the clinical program and reported financial results for the first quarter ended March 31, 2022.
“We remain focused on the continued advancement of our late-stage INOpulse® inhaled nitric oxide therapy platform for the treatment of fibrotic interstitial lung disease, or fILD, and pulmonary hypertension associated with sarcoidosis, or PH-Sarc,” said Naseem Amin, MD, president of the Bellerophon Board of Directors. “Recruitment is progressing in our pivotal Phase 3 REBUILD study, following the recent moderation of the COVID-19 pandemic. In PH-Sarc, following the announcement of positive early results from our Phase 2 proof-of-concept study of INOpulse, we are working with key lung disease experts on the design of a treatment follow-up trial phase 2 study to assess the long-term benefits of INOpulse in patients with PH-Sarc and intend to discuss this potential study with the US Food and Drug Administration in the near future. We believe our balance sheet, with $20 million in cash and cash equivalents, positions us to advance our planned clinical and regulatory activities. »
Clinical Program Highlights:
Fibrotic interstitial lung disease (mILD)
- REBUILD phase 3 study: Enrollment continues in Bellerophon’s REBUILD Phase 3 registrational study of INOpulse for the treatment of fILD. The REBUILD study plans to enroll 300 fILD patients who will be treated either with INOpulse at a dose of iNO45 or with a placebo. The primary endpoint is change in moderate-to-vigorous physical activity (MVPA). If approved, INOpulse would become the first treatment to treat a large population of PID including patients at low, intermediate and high risk of pulmonary hypertension.
The Phase 3 program builds on positive early results from the Company’s previously announced Phase 2 studies for INOpulse for the treatment of FILD. Acute treatment with INOpulse showed benefit on several 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 evaluated over four months showed an average improvement in MVPA of 20% compared to placebo. Improvements in MVPA were supported by overall activity benefits, as well as two patient-reported questionnaires, the University of California San Diego Shortness of Breath Questionnaire and the St. George.
Pulmonary hypertension-sarcoidosis (PH-Sarc)
- Phase 2 clinical study: In December 2021, Bellerophon reported positive initial 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). PH-Sarc is an unmet medical need with no approved therapies and a median survival of approximately five years after diagnosis. The Phase 2 trial was designed as a proof-of-concept study to determine if iNO could demonstrate hemodynamic benefit in PH-Sarc.
All eight subjects demonstrated decreases in mean pulmonary arterial pressure (PAPm) and pulmonary vascular resistance (PVR) across the doses of INOpulse used in the study. The dose of iNO45 (45 mcg/kg IBW/hr) caused a median 20% (-54% to +22%) decrease in PVR, compared to a baseline median PVR of 329 dynes/cm.sec- 5; a reduction of 20% or more in PVR is generally considered clinically significant. Along with improvements in PVR, mPAP decreased by a median of 6-10% for doses of iNO30 to iNO125, compared to a median baseline mPAP of 37.2 mmHg. No treatment-related adverse events (TEAEs) or serious adverse events (TESAEs) occurred during the acute hemodynamic dose escalation phase of the study.
Financial results for the first quarter ended March 31, 2022:
For the first quarter ended March 31, 2022, the Company reported a net loss of $5.6 million, or ($0.59) per share, compared to a net loss of $5.5 million, or ( $0.58) per share, for the first quarter ended March 31, 2021.
Research and development expenses for the first quarter ended March 31, 2022 were $4.4 million, compared to $3.6 million in the first quarter of 2021. The increase was primarily due to costs related to the ongoing phase 3 fILD trial.
General and administrative expenses for the first quarter ended March 31, 2022 were $1.2 million compared to $2.3 million in the first quarter of 2021. The decrease was primarily due to lower consulting, labor and stock-based compensation.
As of March 31, 2022, the Company had cash and cash equivalents of $20.0 million, compared to cash and cash equivalents of $24.7 million as of December 31, 2021.
Bellerophon Therapeutics is a clinical-stage biotherapeutics company focused on developing innovative therapies that address significant unmet medical needs in the treatment of cardiopulmonary disease. The Company is currently developing several product candidates under its INOpulse® program, an exclusive pulsatile nitric oxide delivery system. For more information, please visit www.bellerophon.com.
Any statements contained in this press release regarding Bellerophon’s future expectations, plans and outlook, including statements regarding the clinical development of its product candidates, regulatory actions regarding the Company’s clinical trials and expectations regarding balance adequacy Company’s cash flow to fund clinical trials, operating and capital expenditures, and other statements containing the words “anticipate”, “believe”, “continue”, “plan”, “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 these forward-looking statements due to di to important factors, including: the risks and uncertainties associated with INOpulse®, the uncertainties inherent in initiating future clinical trials, the availability and timing of ongoing and future clinical trial data and the results of such trials, whether preliminary or interim results of a clinical trial are predictive of final results of this trial or whether the results of early clinical trials will be indicative of the results of subsequent clinical trials, expectations for regulatory approvals, substantial FDA discretion in the approval process, availability of sufficient funding to our predictable and unpredictable 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 of the Securities and Exchange Commission. Further, any forward-looking statements included in this press release represent the views of Bellerophon only as of the date of this release and should not be relied upon as representing the views of the Company as of any subsequent date. The Company specifically disclaims any obligation to update any forward-looking statements included in this press release.
|BELLEROPHON THERAPEUTICS, INC.
Consolidated balance sheets
(Amounts in thousands, except per share and per share data)
|March 31, 2022||December 31, 2021|
|Cash and cash equivalents||$||20,000||$||24,736|
|Prepaid expenses and other current assets||413||620|
|Total current assets||20,516||25,459|
|Restricted cash, non-current||300||300|
|Rights of use, net||697||863|
|Property and equipment, net||46||67|
|Other non-current assets||186||186|
|Liabilities and equity|
|Accumulated research and development||1,857||1,397|
|Current portion of operating lease debts||765||752|
|Total current liabilities||5,566||5,052|
|Long-term operating lease debts||8||203|
|Liability related to common share purchase warrants||1||1|
|Commitments and contingencies|
|Common shares, par value of $0.01 per share; 200,000,000 shares authorized and 9,545,451 and 9,545,451 shares issued and outstanding as of March 31, 2022 and December 31, 2021, respectively||95||95|
|Preferred shares, par value of $0.01 per share; 5,000,000 shares authorized, zero shares issued and outstanding as of March 31, 2022 and December 31, 2021||—||—|
|Accumulated deficit||(237,888||)||(232 247||)|
|Full shareholder equity||16,170||21,619|
|Total Liabilities and Equity||$||21,745||$||26,875|
|BELLEROPHON THERAPEUTICS, INC.
Consolidated Statement of Income and Comprehensive Income
(Amounts in thousands, except per share and per share data)
|Three months completed|
|Operating costs :|
|Research and development||$||4,409||$||3,584|
|general and administrative||1,233||2,275|
|Total operating expenses||5,642||5,859|
|Change in fair value of liability for common share purchase warrants||—||397|
|Interest and other income, net||1||1|
|Loss before tax||(5,641||)||(5,461||)|
|Net loss and comprehensive loss||$||(5,641||)||$||(5,461||)|
|Weighted average number of shares outstanding:|
|Net loss per share:|