GlobeNewswire Inc | Mar 11, 2021 08:30AM EST

March 11, 2021

WARREN, N.J., March 11, 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 fourth quarter and year ended December 31, 2020.

Bellerophon continues to make significant progress in advancing its INOpulse inhaled nitric oxide therapy in multiple indications, saidFabian Tenenbaum, Chief Executive Officer of Bellerophon. In December 2020, we announced that the first patient had been enrolled in our pivotal Phase 3 REBUILD study for fibrotic interstitial lung disease (fILD) patients at risk of associated pulmonary hypertension. In addition, we expect top-line results from our Phase 2 dose escalation study of INOpulse in sarcoidosis (PH-Sarc) this year.

Our balance sheet continues to be strong and provides us with the resources to support our ongoing clinical programs in fILD and PH-Sarc, concluded Mr. Tenenbaum.

Clinical Program Highlights:fILD

-- REBUILD Phase 3 Study:In December, 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 will 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 Companys 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, theUniversity of California, San Diego Shortness of Breath Questionnaire and the St. Georges Respiratory Questionnaire.

Pulmonary Hypertension-Sarcoidosis (PH-Sarc)

-- Phase 2 Clinical Study:Bellerophon is continuing enrollment in a Phase 2 dose escalation study in PH-Sarc and anticipates the availability of top-line data during 2021. 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 a median survival of approximately five years after diagnosis. Similar to PH associated with fILD, there are currently no approved therapies to treat PH-Sarc.

COVID-19 (Coronavirus)

-- COViNOX Phase 3 Study:The randomized, placebo-controlled COViNOX study evaluated the efficacy and safety of the investigational INOpulse therapy in patients diagnosed with COVID-19 who require supplemental oxygen. In November 2020, the Company announced the results of a pre-specified interim analysis conducted by an independent Data Monitoring Committee (DMC). Based on the recommendation of the DMC, the COViNOX study was placed on clinical hold. Upon completion of the protocol defined monitoring period, the safety and efficacy analysis of the full 191 patients was reviewed by the DMC, and the DMC determined that there were no safety concerns attributed to INOpulse. However, based on the absence of an efficacy signal and the availability of multiple vaccines, the Company will not be continuing the COViNOX trial.

Corporate Update:

-- In 2020, a patent covering the shape of the nitric oxide pulse and valve configuration of our proprietary INOpulse drug delivery device was issued in the U.S. with an expiry date of June 2039. The issued patent builds upon the Companys portfolio of over 100 issued and pending patent applications and the Orphan Drug Designation for nitric oxide for the treatment of idiopathic pulmonary fibrosis in the U.S., which can provide up to 7 years of exclusivity if the product is approved. -- InNovember 2020, the Company presented at theH.C. Wainwright 6th Annual Israel Conference. -- In January 2021, Bellerophon presented at the H.C. Wainwright Virtual BioConnect 2021 Conference.

Fourth Quarter Financial Results:For the fourth quarter endedDecember 31, 2020, the Company reported a net loss of$8.0 million, or$(0.84)per share, compared to a net loss of$4.1 million, or$(0.89)per share, in the fourth quarter endedDecember 31, 2019.

Net loss for the three months endedDecember 31, 2020included income of$0.4 milliondue to a change in fair value of the Companys common stock warrant liability, as compared to$0.2 millionin the fourth quarter of 2019.

Research and development expenses for the fourth quarter endedDecember 31, 2020were$6.1 million, compared to $2.8 million in the prior year period.The increase was primarily due to costs related to the Phase 3 COVID-19 and fILD trials.

General and administrative expenses for the fourth quarter endedDecember 31, 2020were$2.0 million, compared to$1.5 millionin the prior year period. The increase was primarily due to IP, consulting, and labor costs.

2020 Year End Financial Results:For the year endedDecember 31, 2020, the Company reported a net loss of$24.7 million, or$(3.17)per share, compared to net loss of$13.3 million, or$(2.95)per share, in the year endedDecember 31, 2019.

Net loss for the year endedDecember 31, 2020included an expense of$0.3 milliondue to a change in fair value of the Companys common stock warrant liability, as compared to an income of$2.7 millionin the year endedDecember 31, 2019.

Research and development expenses for the year ended December 31, 2020were$17.9 million, compared to$11.0 millionin the year endedDecember 31, 2019. The increase was primarily due to costs related to the Phase 3 COVID-19 and fILD trials.

General and administrative expenses for the year endedDecember 31, 2020 were$8.4 million, compared to$6.4 millionfor the year endedDecember 31, 2019. The increase was primarily due to IP, consulting, and labor costs.

Balance SheetAs ofDecember 31, 2020, the Company had cash and cash equivalents of$47.6 million, compared to cash and cash equivalents of$9.9 millionatDecember 31, 2019.

About BellerophonBellerophon Therapeuticsis 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 INOpulseprogram, a proprietary pulsatile nitric oxide delivery system. For more information, please visitwww.bellerophon.com.

Forward-looking StatementsAny statements in this press release about Bellerophons future expectations, plans and prospects, including statements about the clinical development of its product candidates, regulatory actions with respect to the Companys clinical trials and expectations regarding the sufficiency of the Companys 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 FDAs 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 Companys 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 Bellerophons views only as of the date of this release and should not be relied upon as representing the Companys views as of any subsequent date. The Company specifically disclaims any obligation to update any forward-looking statements included in this press release.

ContactsLifeSci Advisors:Brian Ritchie (212) 915-2578britchie@lifesciadvisors.com

BELLEROPHON THERAPEUTICS,INC.

Consolidated Balance Sheets

(Amounts in thousands, except share and per share data)

December31,2020 December31,2019Assets Current assets: Cash and cash equivalents $ 47,557 $ 9,874 Restricted cash 103 103 Prepaid expenses and other 420 405 current assetsTotal current assets 48,080 10,382 Restricted cash, non-current 300 300 Right of use assets, net 1,504 2,110 Property and equipment, net 169 316 Other non-current assets 186 ? Total assets $ 50,239 $ 13,108 Liabilities and Stockholders' EquityCurrent liabilities: Accounts payable $ 3,725 $ 3,106 Accrued research and development 3,699 2,117 Accrued expenses 2,305 1,703 Current portion of operating 704 658 lease liabilitiesTotal current liabilities 10,433 7,584 Long term operating lease 956 1,659 liabilitiesCommon stock warrant liability 601 274 Total liabilities 11,990 9,517 Commitments and contingencies Stockholders' equity: Common stock, $0.01 par value pershare; 200,000,000 sharesauthorized and9,491,111 and 4,580,127 shares 95 46 issued and outstanding atDecember31,2020and December31,2019,respectivelyPreferred stock, $0.01 par valueper share; 5,000,000 sharesauthorized, zero ? ? shares issued and outstanding atDecember31,2020 andDecember31,2019Additional paid-in capital 252,645 193,308 Accumulated deficit (214,491 ) (189,763 )Total stockholders' equity 38,249 3,591 Total liabilities and $ 50,239 $ 13,108 stockholders' equity

BELLEROPHON THERAPEUTICS,INC.

Consolidated Statements of Operations

(Amounts in thousands, except share and per share data)

Year Ended December31, 2020 2019 Operating expenses: Research and development $ 17,890 $ 11,032 General and administrative 8,386 6,441 Total operating expenses 26,276 17,473 Loss from operations (26,276 ) (17,473 ) Change in fair value of common stock (327 ) 2,682 warrant liabilityWarrant amendment charge ? (674 ) Interest income and financing (250 ) 397 expenses, netPre-tax loss (26,853 ) (15,068 ) Income tax benefit 2,125 1,801 Net (loss) income $ (24,728 ) $ (13,267 ) Weighted average shares outstanding: Basic 7,797,130 4,503,375 Diluted 7,797,130 4,503,375 Net (loss) income per share: Basic $ (3.17 ) $ (2.95 ) Diluted $ (3.17 ) $ (2.95 )