WARREN, N.J., Nov. 07, 2018 (GLOBE NEWSWIRE) -- Bellerophon Therapeutics, Inc. (Nasdaq: BLPH) (“Bellerophon” or the “Company”), a clinical-stage biotherapeutics company, today provided a business update and reported financial results for the third quarter ended September 30, 2018.
“We are pleased to have completed enrollment in the first cohort of our inhaled nitric oxide for pulmonary fibrosis (iNO-PF) Phase 2b study in pulmonary hypertension associated with interstitial lung disease (PH-ILD), and look forward to the results, which are expected in January 2019,” said Fabian Tenenbaum, Chief Executive Officer of Bellerophon. “The additional cohorts are expected to begin enrolling later this year, with results anticipated in 2019. The additional cohorts will allow us to assess higher doses of inhaled nitric oxide (iNO), along with longer duration of treatment, enabling us to plan for a potential pivotal Phase 3 program. In addition, we expect to initiate a Phase 2a trial to evaluate the hemodynamic benefit of INOpulse in pulmonary hypertension associated with Sarcoidosis (PH-Sarcoidosis) by year-end 2018, with results expected in 2019. Moreover, we recently finalized the design of our Phase 2b study for INOpulse in pulmonary hypertension associated with chronic obstructive pulmonary disease (PH-COPD), and intend to initiate this trial in 2019. All three of our target indications, PH-ILD, PH-COPD and PH-Sarcoidosis, represent significant unmet medical needs with mean survival as low as two years from diagnosis. INOpulse’s unique targeted vasodilation differentiates it from current vasodilators and offers the potential for it to be the first approved therapy in these indications.”
“Although our INOvation-1 trial for INOpulse in pulmonary arterial hypertension (PAH) did not achieve its primary endpoint of six-minute walk distance (6MWD), we believe that the collective results from the trial support the cardio-pulmonary benefits of iNO,” continued Mr. Tenenbaum. “The results showed clinical benefit in hemodynamics and right ventricular function consistent with currently marketed PAH therapies. In addition, subjects not on prostanoids or multiple background therapies experienced an improvement in 6MWD. These results support the potential benefit that INOpulse can provide in PH-ILD, PH-COPD and PH-Sarcoidosis, where patients are not on any background PAH medications.”
Key Recent Highlights
Third quarter 2018 Financial Results
For the third quarter ended September 30, 2018, the Company reported a net income of $11.1 million, or $0.19 per share, compared to a net loss of $7.6 million, or $(0.22) per share, in the third quarter ended September 30, 2017. On a diluted basis, the Company reported a loss of $(0.10) per share for the third quarter ended September 30, 2018, compared to a loss $(0.22) per share, in the third quarter ended September 30, 2017.
Net income for the third quarter of 2018 included an adjustment of $17.8 million due to a change in fair value of the Company’s common stock warrant liability, as compared to an adjustment of $(1.4) million in the third quarter of 2017.
Research and development expenses for the third quarter of 2018 were $5.2 million, compared to $4.4 million in the third quarter of 2017. The increase was primarily due to increased clinical trial activities and supply costs related to ongoing clinical programs.
General and administrative expenses for the third quarter of 2018 were $1.6 million, compared to $1.7 million in third quarter of 2017. The decrease was primarily due to a reduction in stock-based compensation expenses.
Nine Months Ended September 30, 2018 Financial Results
For the nine months ended September 30, 2018, the Company’s net income was $3.7 million, compared to a net loss of $30.7 million in the prior year period. Net income per share was $0.06 in the nine months ended September 30, 2018, compared to a net loss of $(0.92) in the prior year period. On a diluted basis, the Company reported a loss of $(0.27) per share for the nine months ended September 30, 2018, compared to a loss of $(0.92) per share in the prior year period.
Net income for the nine months ended September 30, 2018, included an adjustment of $21.2 million in the fair value of the Company’s common stock warrant liability, as compared to an adjustment of $(13.5) million in the prior year period.
Research and development expenses for the nine months ended September 30, 2018, increased to $17.4 million, as compared to $12.5 million in the prior year period. The increase was primarily due to increased clinical trial activities and supply costs related to ongoing clinical programs.
General and administrative expenses for the nine months ended September 30, 2018, were $5.8 million, as compared to $4.8 million in the prior year period. The increase was primarily due to increased commercial, intellectual property and financial consulting expenses, and stock-based compensation expenses.
As of September 30, 2018, the Company had cash, cash equivalents and marketable securities of $20.6 million, compared to cash, cash equivalents and marketable securities of $31.8 million at December 31, 2017.
Bellerophon Therapeutics is a clinical-stage biotherapeutics company focused on developing innovative therapies at the intersection of drugs and devices 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,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “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: 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.
|At Bellerophon:||At LifeSci Advisors:|
|Fabian Tenenbaum, Chief Executive Officer||Brian Ritchie|
|(908) 574-4767||(212) 915-2578|
|BELLEROPHON THERAPEUTICS, INC.|
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands except share and per share data)
|As of||As of|
|September 30, 2018||December 31, 2017|
|Cash and cash equivalents||$||19,552||$||28,823|
|Prepaid expenses and other current assets||1,738||3,359|
|Total current assets||22,543||35,580|
|Restricted cash, non-current||300||150|
|Other non-current assets||44||54|
|Property and equipment, net||755||1,026|
|Liabilities and Stockholders’ Equity (Deficiency in Assets)|
|Accrued research and development||3,823||1,785|
|Total current liabilities||9,074||7,079|
|Common stock warrant liability||10,641||32,325|
|Commitments and contingencies|
|Stockholders’ equity (deficiency in assets):|
|Common stock, $0.01 par value per share; 200,000,000 and 125,000,000 shares authorized and 58,679,492 and 56,899,353 shares issued and outstanding at September 30, 2018 and December 31, 2017, respectively, 289,269 shares paid for and to be issued at December 31, 2017||587||569|
|Preferred stock, $0.01 par value per share; 5,000,000 shares authorized, zero shares issued and outstanding at September 30, 2018 and December 31, 2017||—||—|
|Additional paid-in capital||178,925||176,151|
|Accumulated other comprehensive loss||(1||)||(4||)|
|Total stockholders’ equity (deficiency in assets)||3,927||(2,594||)|
|Total liabilities and stockholders’ equity (deficiency in assets)||$||23,642||$||36,810|
|BELLEROPHON THERAPEUTICS, INC.|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
(in thousands except share and per share data)
|Three Months Ended|
|Nine Months Ended|
|Research and development||$||5,247||$||4,438||$||17,442||$||12,464|
|General and administrative||1,584||1,746||5,754||4,826|
|Total operating expenses||6,831||6,184||23,196||17,290|
|Loss from operations||(6,831||)||(6,184||)||(23,196||)||(17,290||)|
|Change in fair value of common stock warrant liability||17,840||(1,435||)||21,201||(13,455||)|
|Interest and other income, net||92||33||282||86|
|Pre-tax income (loss)||11,101||(7,586||)||(1,713||)||(30,659||)|
|Income tax benefit||—||—||5,439||—|
|Net income (loss)||$||11,101||$||(7,586||)||$||3,726||$||(30,659||)|
|Weighted average shares outstanding:|
|Net income (loss) per share:|