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WARREN, N.J., Nov. 14, 2022 (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, 2022.
“We continue to achieve important progress in advancing the ongoing REBUILD Phase 3 trial of INOpulse® for the treatment of fibrotic Interstitial Lung Disease (fILD),” said Naseem Amin, M.D., Chairman of Bellerophon’s Board of Directors.
“With the recent U.S. Food and Drug Administration (FDA) acceptance of the reduction in the study sample size, we are well positioned to accelerate the completion of the REBUILD study, which is now approximately 85% enrolled. We expect that enrollment will conclude in the first quarter of 2023, with the reporting of pivotal top-line data in third quarter of 2023,” said Peter Fernandes, Bellerophon’s Principal Executive Officer.
Clinical Program Highlights:
Fibrotic Interstitial Lung Disease (fILD)
Pulmonary Hypertension-Sarcoidosis (PH-Sarc)
Third Quarter Ended September 30, 2022, Financial Results:
For the three months ended September 30, 2022, the Company reported a net loss of $5.1 million, or $(0.53) per basic and diluted share, compared to a net loss of $4.6 million, or $(0.49) per basic and diluted share, for the three months ended September 30, 2021.
Research and development expenses for the three months ended September 30, 2022, were $3.8 million, compared to $ 3.0 million in the prior year period. The increase was primarily due to the ongoing Phase 3 fILD trial.
General and administrative expenses for the three months ended September 30, 2022, were $1.4 million, as compared to $1.8 million in the prior year period. The decrease was primarily due to due to fewer labor, and stock-based compensation costs.
Nine Months Ended September 30, 2022, Financial Results:
For the nine months ended September 30, 2022, the Company reported a net loss of $14.8 million, or $(1.55) per basic and diluted share, compared to a net loss of $13.5 million, or $(1.42) per basic and diluted share, in the nine months ended September 30, 2021.
Research and development expenses for the nine months ended September 30, 2022 were $12.6 million, compared to $9.9 million in the prior year period. The increase was primarily due to the ongoing Phase 3 fILD trial.
General and administrative expenses for the nine months ended September 30, 2022 were $4.7 million, compared to $6.0 million in the prior year period. The decrease was primarily due to lower consulting, labor, and stock-based compensation costs.
Balance Sheet
As of September 30, 2022, the Company had unrestricted cash and cash equivalents of $11.3 million, compared to unrestricted cash and cash equivalents of $24.7 million on December 31, 2021.
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, 2022 | December 31, 2021 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 11,317 | $ | 24,736 | ||||
| Restricted cash | 404 | 103 | ||||||
| Prepaid expenses and other current assets | 338 | 620 | ||||||
| Total current assets | 12,059 | 25,459 | ||||||
| Restricted cash, non-current | — | 300 | ||||||
| Right of use assets, net | 357 | 863 | ||||||
| Property and equipment, net | 6 | 67 | ||||||
| Other non-current assets | 186 | 186 | ||||||
| Total assets | $ | 12,608 | $ | 26,875 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,525 | $ | 1,192 | ||||
| Accrued research and development | 1,888 | 1,397 | ||||||
| Accrued expenses | 1,370 | 1,711 | ||||||
| Current portion of operating lease liabilities | 396 | 752 | ||||||
| Total current liabilities | 5,179 | 5,052 | ||||||
| Long term operating lease liabilities | — | 203 | ||||||
| Common stock warrant liability | 1 | 1 | ||||||
| Total liabilities | 5,180 | 5,256 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' equity: | ||||||||
| Common stock, $0.01 par value per share; 200,000,000 shares authorized and 9,545,451 and 9,545,451 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively | 95 | 95 | ||||||
| Preferred stock, $0.01 par value per share; 5,000,000 shares authorized, zero shares issued and outstanding at September 30, 2022 and December 31, 2021 | — | — | ||||||
| Additional paid-in capital | 254,395 | 253,771 | ||||||
| Accumulated deficit | (247,062 | ) | (232,247 | ) | ||||
| Total stockholders' equity | 7,428 | 21,619 | ||||||
| Total liabilities and stockholders' equity | $ | 12,608 | $ | 26,875 | ||||
BELLEROPHON THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED)
(in thousands except share and per share data)
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 3,750 | $ | 3,030 | $ | 12,646 | $ | 9,853 | ||||||||
| General and administrative | 1,366 | 1,773 | 4,653 | 6,035 | ||||||||||||
| Total operating expenses | 5,116 | 4,803 | 17,299 | 15,888 | ||||||||||||
| Loss from operations | (5,116 | ) | (4,803 | ) | (17,299 | ) | (15,888 | ) | ||||||||
| Change in fair value of common stock warrant liability | — | 167 | — | 600 | ||||||||||||
| Interest and other income, net | 47 | 2 | 67 | 4 | ||||||||||||
| Pre-tax loss | (5,069 | ) | (4,634 | ) | (17,232 | ) | (15,284 | ) | ||||||||
| Income tax benefit | — | — | 2,417 | 1,800 | ||||||||||||
| Net loss and comprehensive loss | $ | (5,069 | ) | $ | (4,634 | ) | $ | (14,815 | ) | $ | (13,484 | ) | ||||
| Weighted average shares outstanding: | ||||||||||||||||
| Basic | 9,545,451 | 9,506,419 | 9,545,451 | 9,501,428 | ||||||||||||
| Diluted | 9,545,451 | 9,506,419 | 9,545,451 | 9,501,428 | ||||||||||||
| Net loss per share: | ||||||||||||||||
| Basic | $ | (0.53 | ) | $ | (0.49 | ) | $ | (1.55 | ) | $ | (1.42 | ) | ||||
| Diluted | $ | (0.53 | ) | $ | (0.49 | ) | $ | (1.55 | ) | $ | (1.42 | ) | ||||