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Bellerophon Provides Clinical Program Update and Reports First Quarter 2021 Financial Results

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WARREN, N.J., May 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 first quarter ended March 31, 2021.

“Bellerophon remains focused on advancing its INOpulse® inhaled nitric oxide therapy in multiple high-value areas of unmet need as expeditiously as possible,” said Fabian Tenenbaum, Chief Executive Officer of Bellerophon. “Enrollment in our ongoing pivotal Phase 3 REBUILD study for fibrotic interstitial lung disease, or fILD, patients at risk of associated pulmonary hypertension continues to advance. We also anticipate top-line results from our Phase 2 dose escalation study of INOpulse in sarcoidosis, or PH-Sarc, later this year. Our ongoing clinical development programs continue to be driven by a strong balance sheet.”

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 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 no approved therapies, and a median survival of approximately five years after diagnosis.

Corporate Update:

  • In March 2021, the Company presented at the H.C. Wainwright Global Life Sciences Conference.

First Quarter Ended March 31, 2021 Financial Results:
For the first quarter ended March 31, 2021, the Company reported a net loss of $5.5 million, or $(0.58) per share, compared to a net loss of $5.0 million, or $(1.08) per share, in the first quarter ended March 31, 2020.

Net loss for the three months ended March 31, 2021 included income of $0.4 million due to a change in fair value of the Company’s common stock warrant liability, as compared to an expense of $0.9 million in the first quarter of 2020.

Research and development expenses for the first quarter ended March 31, 2021 were $3.6 million, compared to $2.2 million in the first quarter of 2020. The increase was primarily due to costs related to the Phase 3 fILD and COVID-19 trials.

General and administrative expenses for the first quarter ended March 31, 2021 were $2.3 million, compared to $1.9 million in the first quarter of 2020. The increase was primarily due to intellectual property, consulting, and labor costs, partially offset by a decrease in stock-based compensation costs.

Balance Sheet
As of March 31, 2021, the Company had cash and cash equivalents of $39.7 million, compared to cash and cash equivalents of $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

March 31, 2021

December 31, 2020

(Unaudited)

Assets

Current assets:

Cash and cash equivalents

$

39,671

$

47,557

Restricted cash

103

103

Prepaid expenses and other current assets

446

420

Total current assets

40,220

48,080

Restricted cash, non-current

300

300

Right of use assets, net

1,347

1,504

Property and equipment, net

140

169

Other non-current assets

186

186

Total assets

$

42,193

$

50,239

Liabilities and Stockholders' Equity

Current liabilities:

Accounts payable

$

3,808

$

3,725

Accrued research and development

1,818

3,699

Accrued expenses

1,745

2,305

Current portion of operating lease liabilities

716

704

Total current liabilities

8,087

10,433

Long term operating lease liabilities

773

956

Common stock warrant liability

204

601

Total liabilities

9,064

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 March 31, 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 March 31, 2021 and December 31, 2020

Additional paid-in capital

252,986

252,645

Accumulated deficit

(219,952

)

(214,491

)

Total stockholders' equity

33,129

38,249

Total liabilities and stockholders' equity

$

42,193

$

50,239


BELLEROPHON THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
(in thousands, except share and per share data)

Three Months Ended

March 31,

2021

2020

Operating expenses:

Research and development

$

3,584

$

2,238

General and administrative

2,275

1,872

Total operating expenses

5,859

4,110

Loss from operations

(5,859

)

(4,110

)

Change in fair value of common stock warrant liability

397

(894

)

Interest and other income, net

1

34

Pre-tax loss

(5,461

)

(4,970

)

Net loss

$

(5,461

)

$

(4,970

)

Weighted average shares outstanding:

Basic

9,491,281

4,615,046

Diluted

9,491,281

4,615,046

Net loss per share:

Basic

$

(0.58

)

$

(1.08

)

Diluted

$

(0.58

)

$

(1.08

)