Delaware
|
|
47-3116175
|
(State or other jurisdiction of
incorporation or organization)
|
|
(I.R.S. Employer
Identification No.)
|
Title of each class
|
Trading Symbol(s)
|
Name of each exchange on which registered
|
Common Stock, $0.01 par value per share
|
BLPH
|
The Nasdaq Capital Market
|
Large accelerated filer
|
|
o
|
|
Accelerated filer
|
|
o
|
Non-accelerated filer
|
|
ý
|
|
Smaller reporting company
|
|
ý
|
|
|
|
|
Emerging growth company
|
|
ý
|
•
|
the timing of the ongoing and expected clinical trials of our product candidates, including statements regarding the timing of completion of the trials and the respective periods during which the results of the trials will become available;
|
•
|
our ability to obtain adequate financing to meet our future operational and capital needs;
|
•
|
the timing of and our ability to obtain marketing approval of our product candidates, and the ability of our product candidates to meet existing or future regulatory standards;
|
•
|
our ability to comply with government laws and regulations;
|
•
|
our commercialization, marketing and manufacturing capabilities and strategy;
|
•
|
our estimates regarding the potential market opportunity for our product candidates;
|
•
|
the timing of or our ability to enter into partnerships to market and commercialize our product candidates;
|
•
|
the rate and degree of market acceptance of any product candidate for which we receive marketing approval;
|
•
|
our intellectual property position;
|
•
|
our estimates regarding expenses, future revenues, capital requirements and needs for additional funding;
|
•
|
the success of competing treatments;
|
•
|
our competitive position; and
|
•
|
our expectations regarding the time during which we will be an “emerging growth company” under the Jumpstart Our Business Startups Act of 2012.
|
|
|
As of
|
|
As of
|
||||
|
|
September 30, 2019
|
|
December 31, 2018
|
||||
|
|
(Unaudited)
|
|
|
||||
Assets
|
|
|
|
|
|
|
||
Current assets:
|
|
|
|
|
|
|
||
Cash and cash equivalents
|
|
$
|
12,838
|
|
|
$
|
16,645
|
|
Restricted cash
|
|
102
|
|
|
101
|
|
||
Prepaid expenses and other current assets
|
|
712
|
|
|
650
|
|
||
Total current assets
|
|
13,652
|
|
|
17,396
|
|
||
Restricted cash, non-current
|
|
300
|
|
|
300
|
|
||
Right of use assets, net
|
|
2,256
|
|
|
—
|
|
||
Property and equipment, net
|
|
401
|
|
|
664
|
|
||
Total assets
|
|
$
|
16,609
|
|
|
$
|
18,360
|
|
Liabilities and Stockholders’ Equity
|
|
|
|
|
|
|
||
Current liabilities:
|
|
|
|
|
|
|
||
Accounts payable
|
|
$
|
2,264
|
|
|
$
|
2,755
|
|
Accrued research and development
|
|
2,581
|
|
|
3,771
|
|
||
Accrued expenses
|
|
1,488
|
|
|
1,013
|
|
||
Current portion of operating lease liabilities
|
|
647
|
|
|
—
|
|
||
Total current liabilities
|
|
6,980
|
|
|
7,539
|
|
||
Long term operating lease liabilities
|
|
$
|
1,828
|
|
|
$
|
—
|
|
Common stock warrant liability
|
|
452
|
|
|
6,965
|
|
||
Total liabilities
|
|
9,260
|
|
|
14,504
|
|
||
Commitments and contingencies
|
|
|
|
|
|
|
||
Stockholders’ equity:
|
|
|
|
|
|
|
||
Common stock, $0.01 par value per share; 200,000,000 shares authorized and 68,906,765 and 58,679,492 shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively
|
|
689
|
|
|
587
|
|
||
Preferred stock, $0.01 par value per share; 5,000,000 shares authorized, zero shares issued and outstanding at September 30, 2019 and December 31, 2018
|
|
—
|
|
|
—
|
|
||
Additional paid-in capital
|
|
192,343
|
|
|
179,765
|
|
||
Accumulated deficit
|
|
(185,683
|
)
|
|
(176,496
|
)
|
||
Total stockholders’ equity
|
|
7,349
|
|
|
3,856
|
|
||
Total liabilities and stockholders’ equity
|
|
$
|
16,609
|
|
|
$
|
18,360
|
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development
|
|
$
|
3,259
|
|
|
$
|
5,247
|
|
|
$
|
8,193
|
|
|
$
|
17,442
|
|
General and administrative
|
|
1,332
|
|
|
1,584
|
|
|
4,965
|
|
|
5,754
|
|
||||
Total operating expenses
|
|
4,591
|
|
|
6,831
|
|
|
13,158
|
|
|
23,196
|
|
||||
Loss from operations
|
|
(4,591
|
)
|
|
(6,831
|
)
|
|
(13,158
|
)
|
|
(23,196
|
)
|
||||
Change in fair value of common stock warrant liability
|
|
215
|
|
|
17,840
|
|
|
2,504
|
|
|
21,201
|
|
||||
Warrant amendment charge
|
|
—
|
|
|
—
|
|
|
(674
|
)
|
|
—
|
|
||||
Interest and other income, net
|
|
89
|
|
|
92
|
|
|
340
|
|
|
282
|
|
||||
Pre-tax (loss) income
|
|
(4,287
|
)
|
|
11,101
|
|
|
(10,988
|
)
|
|
(1,713
|
)
|
||||
Income tax benefit
|
|
—
|
|
|
—
|
|
|
1,801
|
|
|
5,439
|
|
||||
Net (loss) income
|
|
$
|
(4,287
|
)
|
|
$
|
11,101
|
|
|
$
|
(9,187
|
)
|
|
$
|
3,726
|
|
Weighted average shares outstanding:
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Basic
|
|
68,303,027
|
|
|
57,710,251
|
|
|
67,229,585
|
|
|
57,356,445
|
|
||||
Diluted
|
|
68,303,027
|
|
|
64,544,504
|
|
|
67,229,585
|
|
|
65,854,903
|
|
||||
Net (loss) income per share:
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Basic
|
|
$
|
(0.06
|
)
|
|
$
|
0.19
|
|
|
$
|
(0.14
|
)
|
|
$
|
0.06
|
|
Diluted
|
|
$
|
(0.06
|
)
|
|
$
|
(0.10
|
)
|
|
$
|
(0.14
|
)
|
|
$
|
(0.27
|
)
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Net (loss) income
|
|
$
|
(4,287
|
)
|
|
$
|
11,101
|
|
|
$
|
(9,187
|
)
|
|
$
|
3,726
|
|
Other comprehensive income
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Unrealized gain on available-for-sale marketable securities
|
|
—
|
|
|
2
|
|
|
—
|
|
|
3
|
|
||||
Total other comprehensive income
|
|
—
|
|
|
2
|
|
|
—
|
|
|
3
|
|
||||
Comprehensive (loss) income
|
|
$
|
(4,287
|
)
|
|
$
|
11,103
|
|
|
$
|
(9,187
|
)
|
|
$
|
3,729
|
|
For the three and nine months ended September 30, 2019:
|
|||||||||||||||||||
|
|
Common Stock
|
|
Additional
|
|
Accumulated
|
|
Total
Stockholders’
|
|||||||||||
|
|
Shares
|
|
Amount
|
|
Paid in Capital
|
|
Deficit
|
|
Equity
|
|||||||||
June 30, 2019
|
|
68,906,765
|
|
|
$
|
689
|
|
|
$
|
192,169
|
|
|
$
|
(181,396
|
)
|
|
$
|
11,462
|
|
Net loss
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(4,287
|
)
|
|
(4,287
|
)
|
||||
Stock-based compensation
|
|
—
|
|
|
—
|
|
|
174
|
|
|
—
|
|
|
174
|
|
||||
September 30, 2019
|
|
68,906,765
|
|
|
$
|
689
|
|
|
$
|
192,343
|
|
|
$
|
(185,683
|
)
|
|
$
|
7,349
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||
December 31, 2018
|
|
58,679,492
|
|
|
$
|
587
|
|
|
$
|
179,765
|
|
|
$
|
(176,496
|
)
|
|
$
|
3,856
|
|
Net loss
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(9,187
|
)
|
|
(9,187
|
)
|
||||
Warrant amendment
|
|
—
|
|
|
—
|
|
|
4,683
|
|
|
—
|
|
|
4,683
|
|
||||
Public offering
|
|
10,000,000
|
|
|
100
|
|
|
6,136
|
|
|
|
|
6,236
|
|
|||||
Stock-based compensation
|
|
227,273
|
|
|
2
|
|
|
1,759
|
|
|
—
|
|
|
1,761
|
|
||||
September 30, 2019
|
|
68,906,765
|
|
|
$
|
689
|
|
|
$
|
192,343
|
|
|
$
|
(185,683
|
)
|
|
$
|
7,349
|
|
|
|
Nine Months Ended September 30,
|
||||||
|
|
2019
|
|
2018
|
||||
Cash flows from operating activities:
|
|
|
|
|
|
|
||
Net (loss) income
|
|
$
|
(9,187
|
)
|
|
$
|
3,726
|
|
Adjustments to reconcile net loss) income to net cash used in operating activities:
|
|
|
|
|
|
|
||
Change in fair value of common stock warrant liability
|
|
(2,504
|
)
|
|
(21,201
|
)
|
||
Warrant amendment charge
|
|
674
|
|
|
—
|
|
||
Stock based compensation
|
|
1,761
|
|
|
2,115
|
|
||
Depreciation
|
|
263
|
|
|
271
|
|
||
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
||
Prepaid expenses and other current assets
|
|
(62
|
)
|
|
1,621
|
|
||
Other non-current assets
|
|
—
|
|
|
10
|
|
||
Accounts payable, accrued research and development, and accrued expenses
|
|
(987
|
)
|
|
2,023
|
|
||
Net cash used in operating activities
|
|
(10,042
|
)
|
|
(11,435
|
)
|
||
Cash flows from investing activities:
|
|
|
|
|
|
|
||
Proceeds from sale of marketable securities
|
|
—
|
|
|
2,001
|
|
||
Net cash provided by investing activities
|
|
—
|
|
|
2,001
|
|
||
Cash flows from financing activities:
|
|
|
|
|
|
|
||
Proceeds from sale of Units in PIPE Offering, net of offering expenses
|
|
—
|
|
|
(28
|
)
|
||
Proceeds received from exercise of warrants
|
|
—
|
|
|
190
|
|
||
Proceeds from issuance of common stock in Public Offering
|
|
6,236
|
|
|
—
|
|
||
Proceeds received from exercise of stock options
|
|
—
|
|
|
4
|
|
||
Net cash provided by financing activities
|
|
6,236
|
|
|
166
|
|
||
|
|
|
|
|
||||
Net change in cash, cash equivalents and restricted cash
|
|
(3,806
|
)
|
|
(9,268
|
)
|
||
Cash, cash equivalents and restricted cash at beginning of period
|
|
17,046
|
|
|
29,375
|
|
||
Cash, cash equivalents and restricted cash at end of period
|
|
$
|
13,240
|
|
|
$
|
20,107
|
|
|
|
|
|
|
|
|
||
Non-cash financing activities:
|
|
|
|
|
|
|
||
Conversion of warrant liability to common stock upon exercise of warrants
|
|
$
|
—
|
|
|
$
|
483
|
|
Reclassification of warrant liability to equity on amendment of warrant agreements
|
|
$
|
4,009
|
|
|
$
|
—
|
|
New right of use asset and operating lease
|
|
$
|
322
|
|
|
$
|
—
|
|
•
|
The risk that the Company will not achieve success in its research and development efforts, including clinical trials conducted by it or its potential collaborative partners.
|
•
|
The expectation that the Company will experience operating losses for the next several years.
|
•
|
Decisions by regulatory authorities regarding whether and when to approve the Company’s regulatory applications as well as their decisions regarding labeling and other matters which could affect the commercial potential of the Company’s products or product candidates.
|
•
|
The risk that the Company will fail to obtain adequate financing to meet its future operational and capital needs.
|
•
|
The risk that the Company will be unable to obtain additional funds on a timely basis and hence there will be substantial doubt about its ability to continue as a going concern.
|
•
|
The risk that key personnel will leave the Company and/or that the Company will be unable to recruit and retain senior level officers to manage its business.
|
|
|
Three Months Ended
September 30, 2019 |
|
Nine Months Ended
September 30, 2019 |
||||
|
|
|
||||||
Cash paid for operating lease liability
|
|
$
|
171
|
|
|
$
|
496
|
|
Operating lease expenses
|
|
160
|
|
|
465
|
|
||
Weighted average remaining lease term
|
|
|
|
3.51 years
|
|
|||
Weighted average discount rate
|
|
|
|
4.94
|
%
|
|||
|
|
|
|
|
||||
Maturities of lease liabilities as of September 30, 2019 were as follows :
|
|
|
|
|
||||
2019
|
|
|
|
$
|
187
|
|
||
2020
|
|
|
|
757
|
|
|||
2021
|
|
|
|
770
|
|
|||
2022
|
|
|
|
783
|
|
|||
2023
|
|
|
|
205
|
|
|||
|
|
|
|
2,702
|
|
|||
Less imputed interest
|
|
|
|
(227
|
)
|
|||
Total operating lease liabilities
|
|
|
|
2,475
|
|
|
|
Equity Classified
|
|
Liability Classified
|
||||||
|
|
Warrants
|
|
Warrants
|
|
Estimated Fair Value
|
||||
Warrants outstanding as of December 31, 2018
|
|
19,449,834
|
|
|
14,801,180
|
|
|
$
|
6,965
|
|
Reclassification of warrants to equity on amendment of warrant agreements
|
|
12,598,572
|
|
|
(12,598,572
|
)
|
|
(4,009
|
)
|
|
Change in fair value of common stock warrant liability recognized in consolidated statement of operations
|
|
—
|
|
|
—
|
|
|
(2,504
|
)
|
|
Warrants outstanding as of September 30, 2019
|
|
32,048,406
|
|
|
2,202,608
|
|
|
$
|
452
|
|
|
|
Equity Classified
|
|
Liability Classified
|
||||||
|
|
Warrants
|
|
Warrants
|
|
Estimated Fair Value
|
||||
Warrants outstanding as of December 31, 2017
|
|
19,449,834
|
|
|
15,041,004
|
|
|
$
|
32,325
|
|
Exercises
|
|
—
|
|
|
(239,824
|
)
|
|
(483
|
)
|
|
Change in fair value of common stock warrant liability recognized in consolidated statement of operations
|
|
—
|
|
|
—
|
|
|
(21,201
|
)
|
|
Warrants outstanding as of September 30, 2018
|
|
19,449,834
|
|
|
14,801,180
|
|
|
$
|
10,641
|
|
•
|
Level 1 — Values are based on unadjusted quoted prices for identical assets or liabilities in an active market which the company has the ability to access at the measurement date.
|
•
|
Level 2 — Values are based on quoted market prices in markets where trading occurs infrequently or whose values are based on quoted prices of instruments with similar attributes in active markets.
|
•
|
Level 3 — Values are based on prices or valuation techniques that require inputs that are both unobservable and significant to the overall fair value measurement. These inputs reflect management’s own assumptions about the assumptions a market participant would use in pricing the asset.
|
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
||||
Common stock warrant liability
|
|
—
|
|
|
—
|
|
|
452
|
|
|
452
|
|
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
||||
Common stock warrant liabilities
|
|
—
|
|
|
—
|
|
|
6,965
|
|
|
6,965
|
|
|
September 30, 2019
|
|
December 31, 2018
|
||
Valuation assumptions:
|
|
|
|
||
Risk-free interest rate
|
1.58
|
%
|
|
2.45
|
%
|
Expected volatility
|
101.55
|
%
|
|
93.61
|
%
|
Expected term (in years)
|
2.6
|
|
|
3.0
|
|
Dividend yield
|
—
|
%
|
|
—
|
%
|
|
Nine Months Ended September 30, 2019
|
Nine Months Ended September 30, 2018
|
||
Valuation assumptions:
|
|
|
|
|
Risk-free rate
|
1.67
|
%
|
2.50
|
%
|
Expected volatility
|
86.02
|
%
|
89.13
|
%
|
Expected term (years)
|
6.0
|
|
5.98
|
|
Dividend yield
|
—
|
|
—
|
|
|
Bellerophon 2015 and 2014 Equity Incentive Plans
|
||||||||||||||
|
Options
|
|
Range of
Exercise
Price
|
|
Weighted
Average
Price
|
|
Weighted Average
Remaining
Contractual
Life (in years)
|
||||||||
Options outstanding as of December 31, 2018
|
6,769,232
|
|
|
$
|
0.49
|
|
-
|
13.28
|
|
|
$
|
2.16
|
|
|
8.6
|
Granted
|
3,323,813
|
|
|
0.50
|
|
-
|
0.88
|
|
|
0.52
|
|
|
|
||
Expired
|
(1,995
|
)
|
|
12.00
|
|
-
|
12.00
|
|
|
12.00
|
|
|
|
||
Forfeited
|
(129,919
|
)
|
|
0.49
|
|
-
|
12.00
|
|
|
2.39
|
|
|
|
||
Options outstanding as of September 30, 2019
|
9,961,131
|
|
|
$
|
0.49
|
|
-
|
13.28
|
|
|
$
|
1.61
|
|
|
8.5
|
Options vested and exercisable as of September 30, 2019
|
3,020,986
|
|
|
$
|
0.49
|
|
-
|
13.28
|
|
|
$
|
3.48
|
|
|
7.2
|
|
|
Bellerophon 2015 Equity Incentive Plan
|
|||||||||||
|
|
Shares
|
|
Weighted
Average
Fair Value
|
|
Aggregate
Grant Date
Fair Value
(in millions)
|
|
Weighted Average
Remaining
Contractual
Life (in years)
|
|||||
Restricted stock outstanding as of December 31, 2018
|
|
965,618
|
|
|
$
|
1.23
|
|
|
$
|
1.2
|
|
|
0.3
|
Granted
|
|
227,273
|
|
|
0.88
|
|
|
0.2
|
|
|
|
||
Vested
|
|
(589,153
|
)
|
|
(1.26
|
)
|
|
(0.7
|
)
|
|
|
||
Restricted stock outstanding as of September 30, 2019
|
|
603,738
|
|
|
$
|
1.07
|
|
|
$
|
0.6
|
|
|
0.1
|
|
|
Ikaria Equity Incentive Plans
|
|||||||||||||
|
|
Options
|
|
Range of
Exercise
Price
|
|
Weighted
Average
Price
|
|
Weighted Average
Remaining
Contractual
Life (in years)
|
|||||||
Options outstanding as of December 31, 2018
|
|
69,619
|
|
|
$
|
7.77
|
|
-
|
17.92
|
|
$
|
9.12
|
|
|
3.2
|
Expired
|
|
(5,588
|
)
|
|
17.92
|
-
|
17.92
|
|
17.92
|
|
|
|
|||
Forfeited
|
|
(11,055
|
)
|
|
7.77
|
-
|
14.91
|
|
8.66
|
|
|
|
|||
Options outstanding as of September 30, 2019
|
|
52,976
|
|
|
$
|
7.77
|
|
-
|
14.91
|
|
$
|
8.28
|
|
|
2.6
|
Options vested and exercisable as of September 30, 2019
|
|
52,976
|
|
|
$
|
7.77
|
|
-
|
14.91
|
|
$
|
8.28
|
|
|
2.6
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Research and development
|
|
$
|
84
|
|
|
$
|
87
|
|
|
$
|
591
|
|
|
$
|
469
|
|
General and administrative
|
|
90
|
|
|
417
|
|
|
1,170
|
|
|
1,646
|
|
||||
Total expense
|
|
$
|
174
|
|
|
$
|
504
|
|
|
$
|
1,761
|
|
|
$
|
2,115
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Net (loss) income
|
$
|
(4,287
|
)
|
|
$
|
11,101
|
|
|
$
|
(9,187
|
)
|
|
$
|
3,726
|
|
Weighted-average shares:
|
|
|
|
|
|
|
|
||||||||
Basic
|
68,303,027
|
|
|
57,710,251
|
|
|
67,229,585
|
|
|
57,356,445
|
|
||||
Effect of dilutive securities:
|
|
|
|
|
|
|
|
||||||||
Warrants
|
—
|
|
|
6,834,253
|
|
|
—
|
|
|
8,498,458
|
|
||||
Diluted
|
68,303,027
|
|
|
64,544,504
|
|
|
67,229,585
|
|
|
65,854,903
|
|
||||
Net (loss) income per share:
|
|
|
|
|
|
|
|
||||||||
Basic
|
$
|
(0.06
|
)
|
|
$
|
0.19
|
|
|
$
|
(0.14
|
)
|
|
$
|
0.06
|
|
Diluted
|
$
|
(0.06
|
)
|
|
$
|
(0.10
|
)
|
|
$
|
(0.14
|
)
|
|
$
|
(0.27
|
)
|
•
|
subjects on iNO demonstrated an increase of 8% in moderate activity versus a 26% decrease for subjects on placebo (p=0.04);
|
•
|
subjects on iNO showed no decline in their overall activity levels versus a 12% decline for subjects on placebo (p=0.05);
|
•
|
subjects on iNO showed an increase of 15% in NT-ProBNP versus a 42% increase for subjects on placebo (NT-ProBNP is a peptide marker of right ventricular failure, with higher levels indicative of disease worsening);
|
•
|
subjects on iNO demonstrated improved oxygen saturation by 9% versus a worsening of 11% for placebo.
|
•
|
23% of subjects on iNO had a clinically significant improvement in Moderate to Vigorous Physical Activity (MVPA), compared to 0% of subjects on placebo. This represents a placebo corrected difference of 23% - a clinically significant improvement is > 15% increase in MVPA from baseline;
|
•
|
39% of subjects on iNO had a clinically significant decline in MVPA, compared to 71% of subjects on placebo. This represents a placebo corrected difference of 32% - a clinically significant improvement is >15% decrease in MVPA from baseline;
|
•
|
Proportion of awake time spent in MVPA improved by 38% (16% increase on iNO vs. 22% decrease on placebo; p=0.04);
|
•
|
Calorie expenditure improved by 12% (6% decrease on iNO vs. 18% decrease on placebo; p=0.05);
|
•
|
Subjects on open-label extension demonstrated consistent improvements in MVPA and overall activity, with subjects transitioning from placebo to open-label experiencing a reversal from worsening to improving.
|
•
|
Responder analysis:
|
▪
|
85% of subjects on placebo declined in MVPA, overall activity and non-sedentary activity;
|
▪
|
46% of subjects on INOpulse improved in MVPA, 62% in overall activity and 39% in non-sedentary activity (compared to only 15% of subjects on placebo in each category).
|
•
|
OLE:
|
▪
|
Collectively, subjects (with an average of 27 weeks of OLE data) demonstrated maintenance of MVPA, overall activity and non-sedentary activity;
|
▪
|
Subjects randomized to active treatment in the blinded portion of the trial continued to maintain their activity levels when transitioning to OLE over 27 weeks of open-label treatment;
|
▪
|
Subjects randomized to placebo in the blinded portion of the trial transitioned from a decline during blinded treatment to stabilization of activity levels (MVPA, overall activity and non-sedentary activity) over 27 weeks of open-label treatment.
|
•
|
expenses incurred under agreements with contract research organizations, investigative sites that conduct our clinical trials and consultants that conduct a portion of our pre-clinical studies;
|
•
|
lab supplies, reagents, active pharmaceutical ingredients and other direct and indirect costs in support of our pre-clinical and clinical activities;
|
|
|
Three Months Ended
September 30, |
|
|
|
|
|||||||||
(Dollar amounts in thousands)
|
|
2019
|
|
2018
|
|
$ Change
|
|
% Change
|
|||||||
Research and development expenses:
|
|
|
|
|
|
|
|
|
|||||||
PH-ILD, PH-Sarc and PH-COPD
|
|
$
|
1,045
|
|
|
$
|
622
|
|
|
$
|
423
|
|
|
68
|
%
|
PAH
|
|
3
|
|
|
1,979
|
|
|
(1,976
|
)
|
|
(100
|
)%
|
|||
BCM
|
|
—
|
|
|
10
|
|
|
(10
|
)
|
|
(100
|
)%
|
|||
Drug and delivery system costs
|
|
501
|
|
|
1,177
|
|
|
(676
|
)
|
|
(57
|
)%
|
|||
Clinical programs
|
|
1,549
|
|
|
3,788
|
|
|
(2,239
|
)
|
|
(59
|
)%
|
|||
Research and development infrastructure
|
|
1,381
|
|
|
1,056
|
|
|
325
|
|
|
31
|
%
|
|||
INOpulse engineering
|
|
329
|
|
|
403
|
|
|
(74
|
)
|
|
(18
|
)%
|
|||
Total research and development expenses
|
|
3,259
|
|
|
5,247
|
|
|
(1,988
|
)
|
|
(38
|
)%
|
|||
General and administrative expenses
|
|
1,332
|
|
|
1,584
|
|
|
(252
|
)
|
|
(16
|
)%
|
|||
Total operating expenses
|
|
4,591
|
|
|
6,831
|
|
|
(2,240
|
)
|
|
(33
|
)%
|
|||
Loss from operations
|
|
(4,591
|
)
|
|
(6,831
|
)
|
|
2,240
|
|
|
(33
|
)%
|
|||
Change in fair value of common stock warrant liability
|
|
215
|
|
|
17,840
|
|
|
(17,625
|
)
|
|
(99
|
)%
|
|||
Interest and other income, net
|
|
89
|
|
|
92
|
|
|
(3
|
)
|
|
(3
|
)%
|
|||
Net loss (income)
|
|
$
|
(4,287
|
)
|
|
$
|
11,101
|
|
|
$
|
(15,388
|
)
|
|
(139
|
)%
|
|
|
Nine Months Ended
September 30, |
|
|
|
|
|||||||||
(Dollar amounts in thousands)
|
|
2019
|
|
2018
|
|
$ Change
|
|
% Change
|
|||||||
Research and development expenses:
|
|
|
|
|
|
|
|
|
|||||||
PH-ILD, PH-Sarc and PH-COPD
|
|
$
|
2,436
|
|
|
$
|
1,516
|
|
|
$
|
920
|
|
|
61
|
%
|
PAH
|
|
98
|
|
|
6,356
|
|
|
$
|
(6,258
|
)
|
|
(98
|
)%
|
||
BCM
|
|
—
|
|
|
26
|
|
|
(26
|
)
|
|
(100
|
)%
|
|||
Drug and delivery system costs
|
|
1,168
|
|
|
4,625
|
|
|
(3,457
|
)
|
|
(75
|
)%
|
|||
Clinical programs
|
|
3,702
|
|
|
12,523
|
|
|
(8,821
|
)
|
|
(70
|
)%
|
|||
Research and development infrastructure
|
|
3,627
|
|
|
3,877
|
|
|
(250
|
)
|
|
(6
|
)%
|
|||
INOpulse engineering
|
|
864
|
|
|
1,042
|
|
|
(178
|
)
|
|
(17
|
)%
|
|||
Total research and development expenses
|
|
8,193
|
|
|
17,442
|
|
|
(9,249
|
)
|
|
(53
|
)%
|
|||
General and administrative expenses
|
|
4,965
|
|
|
5,754
|
|
|
(789
|
)
|
|
(14
|
)%
|
|||
Total operating expenses
|
|
13,158
|
|
|
23,196
|
|
|
(10,038
|
)
|
|
(43
|
)%
|
|||
Loss from operations
|
|
(13,158
|
)
|
|
(23,196
|
)
|
|
10,038
|
|
|
(43
|
)%
|
|||
Change in fair value of common stock warrant liability
|
|
2,504
|
|
|
21,201
|
|
|
(18,697
|
)
|
|
(88
|
)%
|
|||
Warrant amendment charge
|
|
(674
|
)
|
|
—
|
|
|
(674
|
)
|
|
N/A
|
||||
Interest and other income, net
|
|
340
|
|
|
282
|
|
|
58
|
|
|
21
|
%
|
|||
Pre-tax loss
|
|
$
|
(10,988
|
)
|
|
$
|
(1,713
|
)
|
|
(9,275
|
)
|
|
541
|
%
|
|
Income tax benefit
|
|
$
|
1,801
|
|
|
$
|
5,439
|
|
|
(3,638
|
)
|
|
(67
|
)%
|
|
Net loss (income)
|
|
$
|
(9,187
|
)
|
|
$
|
3,726
|
|
|
(12,913
|
)
|
|
(347
|
)%
|
•
|
progress and cost of our clinical trials and other research and development activities;
|
•
|
our ability to manufacture sufficient supply of our product candidates and the costs thereof;
|
•
|
the cost and timing of seeking regulatory approvals;
|
•
|
the costs and timing of future commercialization activities, including product manufacturing, marketing, sales and distribution for any of our product candidates for which we receive marketing approval;
|
•
|
the number and development requirements of any other product candidates we pursue;
|
•
|
our ability to enter into collaborative agreements and achieve milestones under those agreements;
|
•
|
the revenue, if any, received from commercial sales of our product candidates for which we receive marketing approval;
|
•
|
the cost of filing, prosecuting, defending and enforcing patent applications, claims, patents and other intellectual property rights; and
|
•
|
the extent to which we acquire or in-license other products and technologies.
|
|
|
Nine Months Ended
September 30, |
||||||
(Dollar amounts in thousands)
|
|
2019
|
|
2018
|
||||
Operating activities
|
|
$
|
(10,042
|
)
|
|
$
|
(11,435
|
)
|
Investing activities
|
|
—
|
|
|
2,001
|
|
||
Financing activities
|
|
6,236
|
|
|
166
|
|
||
Net change in cash, cash equivalents and restricted cash
|
|
$
|
(3,806
|
)
|
|
$
|
(9,268
|
)
|
Exhibit
Number
|
|
Description
|
|
||
|
||
|
||
101.INS
|
|
XBRL Instance Document
|
101.SCH
|
|
XBRL Taxonomy Extension Schema Document
|
101.CAL
|
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
101.DEF
|
|
XBRL Taxonomy Extension Definition Linkbase Document
|
101.LAB
|
|
XBRL Taxonomy Extension Label Linkbase Document
|
101.PRE
|
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
|
BELLEROPHON THERAPEUTICS, INC.
|
|
|
|
|
Date: November 6, 2019
|
By:
|
/s/ Fabian Tenenbaum
|
|
|
Fabian Tenenbaum
|
|
|
Chief Executive Officer
(Principal Executive Officer)
|
|
|
|
|
|
|
Date: November 6, 2019
|
By:
|
/s/ Assaf Korner
|
|
|
Assaf Korner
|
|
|
Chief Financial Officer
|
|
|
(Principal Financial Officer)
|
Date: November 6, 2019
|
By:
|
/s/ Fabian Tenenbaum
|
|
|
Fabian Tenenbaum
|
|
|
Chief Executive Officer
|
|
|
(Principal Executive Officer)
|
Date: November 6, 2019
|
By:
|
/s/ Assaf Korner
|
|
|
Assaf Korner
|
|
|
Chief Financial Officer
|
|
|
(Principal Financial Officer)
|
|
|
|
|
|
|
Date: November 6, 2019
|
By:
|
/s/ Fabian Tenenbaum
|
|
|
Fabian Tenenbaum
Chief Executive Officer
(Principal Executive Officer)
|
|
|
|
|
|
|
Date: November 6, 2019
|
By:
|
/s/ Assaf Korner
|
|
|
Assaf Korner
Chief Financial Officer
(Principal Financial Officer)
|