WARREN, N.J., Nov. 15, 2021 (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 third quarter ended September 30, 2021.
“We remain focused on advancing the development of our INOpulse® inhaled nitric oxide therapy in fibrotic interstitial lung disease, or fILD, and sarcoidosis, or PH-Sarc, which are two areas of severe unmet medical need,” said Naseem Amin, M.D., Chairman of Bellerophon’s Board of Directors. “Our pivotal Phase 3 REBUILD study in fILD is continuing to enroll. Importantly, INOpulse is the first potential therapy to treat a broad fILD population that includes patients at low, intermediate, and high risk of associated pulmonary hypertension. In addition, we are pleased to have concluded enrollment in our PH-Sarc Phase 2 dose escalation study and expect the availability of top-line results before the end of this year. Finally, with $28.7 million in cash and cash equivalents, we believe that we are in a strong financial position to continue advancing our late-stage 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 has concluded enrollment in a Phase 2 dose escalation study in PH-Sarc and anticipates the availability of top-line data by the end of this year. 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 September 2021, the Company presented at the H.C. Wainwright 23rd Annual Global Investment Conference.
Third Quarter Ended September 30, 2021 Financial Results
For the three months ended September 30, 2021, the Company reported an operating loss of $4.8 million, compared to $8.3 million in the three months ended September 30, 2020.
For the three months ended September 30, 2021, the Company reported a net loss of $4.6 million, or $(0.49) per basic and diluted share, compared to a net loss of $7.9 million, or $(0.84) per basic and diluted share, for the three months ended September 30, 2020.
Research and development expenses for the three months ended September 30, 2021 were $3.0 million, compared to $6.1 million for the three months ended September 30, 2020. The decrease was primarily due to the close-out of activities related to the development of INOpulse for the treatment of COVID-19.
General and administrative expenses for the three months ended September 30, 2021 were $1.8 million, compared to $2.2 million for the three months ended September 30, 2020. The decrease was primarily due to a decrease in consulting and stock-based compensation costs.
Nine Months Ended September 30, 2021 Financial Results
For the nine months ended September 30, 2021, the Company reported an operating loss of $15.9 million, compared to $18.1 million in the nine months ended September 30, 2020.
For the nine months ended September 30, 2021, the Company reported a net loss of $13.5 million, or $(1.42) per basic and diluted share, compared to a net loss of $16.7 million, or $(2.31) per basic and diluted share, for the nine months ended September 30, 2020.
Net loss for the nine months ended September 30, 2021 included an income of $0.6 million due to a change in fair value of the Company’s common stock warrant liability, as compared to an expense of $0.8 million for the nine months ended September 30, 2020.
Research and development expenses for the nine months ended September 30, 2021 were $9.9 million, compared to $11.8 million for the nine months ended September 30, 2020. The decrease was primarily due to the close-out of activities related to the development of INOpulse for the treatment of COVID-19.
General and administrative expenses for the nine months ended September 30, 2021 were $6.0 million, compared to $6.4 million for the nine months ended September 30, 2020. The decrease was primarily due to a decrease in consulting and stock-based compensation costs.
Balance Sheet
As of September 30, 2021, the Company had cash and cash equivalents of $28.7 million, compared to $47.6 million at December 31, 2020.
About Bellerophon
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.
Forward-looking Statements
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.
Contacts
LifeSci Advisors:
Brian Ritchie
(212) 915-2578
britchie@lifesciadvisors.com
|
BELLEROPHON THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands except share and per share data) |
|
As of |
|
As of |
|
September 30, 2021 |
|
December 31, 2020 |
|
(Unaudited) |
|
|
|
| Assets |
|
|
|
|
|
| Current assets: |
|
|
|
|
|
| Cash and cash equivalents |
$ |
28,714 |
|
|
$ |
47,557 |
|
| Restricted cash |
|
103 |
|
|
|
103 |
|
| Prepaid expenses and other current assets |
|
898 |
|
|
|
420 |
|
| Total current assets |
|
29,715 |
|
|
|
48,080 |
|
| Restricted cash, non-current |
|
300 |
|
|
|
300 |
|
| Right of use assets, net |
|
1,026 |
|
|
|
1,504 |
|
| Property and equipment, net |
|
88 |
|
|
|
169 |
|
| Other non-current assets |
|
186 |
|
|
|
186 |
|
| Total assets |
$ |
31,315 |
|
|
$ |
50,239 |
|
| Liabilities and Stockholders' Equity |
|
|
|
|
|
| Current liabilities: |
|
|
|
|
|
| Accounts payable |
$ |
1,278 |
|
|
$ |
3,725 |
|
| Accrued research and development |
|
1,314 |
|
|
|
3,699 |
|
| Accrued expenses |
|
1,795 |
|
|
|
2,305 |
|
| Current portion of operating lease liabilities |
|
740 |
|
|
|
704 |
|
| Total current liabilities |
|
5,127 |
|
|
|
10,433 |
|
| Long term operating lease liabilities |
|
396 |
|
|
|
956 |
|
| Common stock warrant liability |
|
1 |
|
|
|
601 |
|
| Total liabilities |
|
5,524 |
|
|
|
11,990 |
|
|
|
|
|
|
|
| Commitments and contingencies |
|
|
|
|
|
|
|
|
|
|
|
| Stockholders' equity: |
|
|
|
|
|
Common stock, $0.01 par value per share; 200,000,000 shares
authorized and 9,506,419 and 9,491,111 shares issued and outstanding
at September 30, 2021 and December 31, 2020, respectively |
|
95 |
|
|
|
95 |
|
Preferred stock, $0.01 par value per share; 5,000,000 shares
authorized, zero shares issued and outstanding at September 30, 2021
and December 31, 2020 |
|
— |
|
|
|
— |
|
| Additional paid-in capital |
|
253,671 |
|
|
|
252,645 |
|
| Accumulated deficit |
|
(227,975 |
) |
|
|
(214,491 |
) |
| Total stockholders' equity |
|
25,791 |
|
|
|
38,249 |
|
| Total liabilities and stockholders' equity |
$ |
31,315 |
|
|
$ |
50,239 |
|
|
|
|
|
|
|
|
|
BELLEROPHON THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
(in thousands except share and per share data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
September 30, |
|
September 30, |
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
| Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
| Research and development |
|
$ |
3,030 |
|
|
$ |
6,065 |
|
|
$ |
9,853 |
|
|
$ |
11,754 |
|
| General and administrative |
|
|
1,773 |
|
|
|
2,196 |
|
|
|
6,035 |
|
|
|
6,376 |
|
| Total operating expenses |
|
|
4,803 |
|
|
|
8,261 |
|
|
|
15,888 |
|
|
|
18,130 |
|
| Loss from operations |
|
|
(4,803 |
) |
|
|
(8,261 |
) |
|
|
(15,888 |
) |
|
|
(18,130 |
) |
| Change in fair value of common stock warrant liability |
|
|
167 |
|
|
|
319 |
|
|
|
600 |
|
|
|
(768 |
) |
| Interest and other income, net |
|
|
2 |
|
|
|
9 |
|
|
|
4 |
|
|
|
50 |
|
| Pre-tax loss |
|
|
(4,634 |
) |
|
|
(7,933 |
) |
|
|
(15,284 |
) |
|
|
(18,848 |
) |
| Income tax benefit |
|
|
— |
|
|
|
— |
|
|
|
1,800 |
|
|
|
2,125 |
|
| Net loss |
|
$ |
(4,634 |
) |
|
$ |
(7,933 |
) |
|
$ |
(13,484 |
) |
|
$ |
(16,723 |
) |
| Weighted average shares outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
| Basic |
|
|
9,506,419 |
|
|
|
9,491,111 |
|
|
|
9,501,428 |
|
|
|
7,228,349 |
|
| Diluted |
|
|
9,506,419 |
|
|
|
9,491,111 |
|
|
|
9,501,428 |
|
|
|
7,228,349 |
|
| Net loss per share: |
|
|
|
|
|
|
|
|
|
|
|
|
| Basic |
|
$ |
(0.49 |
) |
|
$ |
(0.84 |
) |
|
$ |
(1.42 |
) |
|
$ |
(2.31 |
) |
| Diluted |
|
$ |
(0.49 |
) |
|
$ |
(0.84 |
) |
|
$ |
(1.42 |
) |
|
$ |
(2.31 |
) |
