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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Rocket Pharmaceuticals Inc | NASDAQ:RCKT | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.70 | 3.07% | 23.47 | 22.51 | 24.20 | 24.00 | 23.09 | 23.63 | 630,425 | 22:30:00 |
☒ |
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
☐ |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
Delaware
|
04-3475813
|
|
(State or other jurisdiction of incorporation or organization)
|
(I.R.S. Employer Identification No.)
|
9 Cedarbrook Drive,
Cranbury, NJ
|
08512
|
|
(Address of principal executive office)
|
(Zip Code)
|
Title of each class
|
Trading Symbol(s)
|
Name of each exchange on which registered
|
Common Stock, $0.01 par value per share
|
RCKT
|
Nasdaq Global Market
|
Large accelerated filer ☒
|
Accelerated filer ☐
|
Non-accelerated filer ☐
|
Smaller reporting company ☐
|
|
Emerging growth company ☐ |
|
Page
|
|
PART I - FINANCIAL INFORMATION
|
||
Item 1.
|
Financial Statements
|
|
4
|
||
5
|
||
6
|
||
7
|
||
8
|
||
9
|
||
Item 2.
|
19
|
|
Item 3.
|
31 |
|
Item 4.
|
31 |
|
PART II - OTHER INFORMATION
|
||
Item 1.
|
31 | |
Item 1A.
|
31 | |
Item 2.
|
32 | |
Item 3.
|
32 | |
Item 4.
|
32 | |
Item 5.
|
32 | |
Item 6.
|
33 | |
34 |
•
|
federal, state, and non-U.S. regulatory requirements, including regulation of our current or any other future product candidates by the U.S. Food
and Drug Administration (“FDA”);
|
•
|
the timing of and our ability to submit regulatory filings with the FDA and to obtain and maintain FDA or other regulatory authority approval of,
or other action with respect to, our product candidates;
|
•
|
our competitors’ activities, including decisions as to the timing of competing product launches, pricing, and discounting;
|
•
|
whether safety and efficacy results of our clinical trials and other required tests for approval of our product candidates provide data to warrant
progression of clinical trials, potential regulatory approval, or further development of any of our product candidates;
|
•
|
our ability to develop, acquire and advance product candidates into, enroll a sufficient number of patients into, and successfully complete,
clinical studies, and our ability to apply for and obtain regulatory approval for such product candidates, within currently anticipated timeframes, or at all;
|
•
|
our ability to establish key collaborations and vendor relationships for our product candidates and any other future product candidates;
|
•
|
our ability to acquire additional businesses, form strategic alliances or create joint ventures and our ability to realize the benefit of such
acquisitions, alliances, or joint ventures;
|
•
|
our ability to successfully develop and commercialize any technology that we may in-license or products we may acquire;
|
•
|
unanticipated delays due to manufacturing difficulties, including the development of our direct manufacturing capabilities for our AAV programs,
and any supply constraints or changes in the regulatory environment; our ability to successfully operate in non-U.S. jurisdictions in which we currently or in the future do business, including compliance with applicable regulatory
requirements and laws;
|
•
|
uncertainties associated with obtaining and enforcing patents to protect our product candidates, and our ability to successfully defend ourselves
against unforeseen third-party infringement claims;
|
•
|
anticipated trends and challenges in our business and the markets in which we operate;
|
•
|
natural and manmade disasters, including pandemics such as COVID-19, including additional strains of COVID-19, or any other health epidemic, and
other force majeures, which could impact our operations, and those of our partners and other participants in the health care industry, and which could adversely impact our clinical studies, preclinical research activities, drug supply and
the global economy as a whole;
|
•
|
the impact of global economic and political developments on our business, including rising inflation and capital market disruptions, the current
conflict in Ukraine, economic sanctions and economic slowdowns or recessions that may result from such developments which could harm our research and development efforts as well as the value of our common stock and our ability to access
capital markets;
|
•
|
our estimates regarding our capital requirements; and
|
•
|
our ability to obtain additional financing and raise capital as necessary to fund operations or pursue business opportunities.
|
Item 1. |
Financial Statements
|
June 30,
2022
|
December 31,
2021
|
|||||||
(unaudited) | ||||||||
Assets
|
||||||||
Current assets:
|
||||||||
Cash and cash equivalents
|
$
|
187,548
|
$
|
232,694
|
||||
Investments
|
133,820
|
156,046
|
||||||
Prepaid expenses and other current assets
|
4,403
|
3,319
|
||||||
Total current assets
|
325,771
|
392,059
|
||||||
Property and equipment, net
|
24,851
|
22,299
|
||||||
Goodwill
|
30,815
|
30,815
|
||||||
Restricted cash
|
1,343
|
1,343
|
||||||
Deposits
|
455
|
455
|
||||||
Operating lease right-of-use assets
|
1,207
|
1,569
|
||||||
Finance lease right-of-use asset
|
47,410
|
48,480
|
||||||
Total assets
|
$
|
431,852
|
$
|
497,020
|
||||
Liabilities and stockholders’ equity
|
||||||||
Current liabilities:
|
||||||||
Accounts payable and accrued expenses
|
$
|
21,840
|
$
|
19,615
|
||||
Operating lease liabilities, current
|
737
|
863
|
||||||
Finance lease liability, current
|
1,712
|
1,689
|
||||||
Total current liabilities
|
24,289
|
22,167
|
||||||
Operating lease liabilities, non-current
|
606
|
905
|
||||||
Finance lease liability, non-current
|
19,210
|
19,144
|
||||||
Other liabilities
|
51
|
80
|
||||||
Total liabilities
|
44,156
|
42,296
|
||||||
Commitments and contingencies (Note 10)
|
||||||||
Stockholders’ equity:
|
||||||||
Preferred stock, $0.01 par value, authorized 5,000,000 shares:
|
||||||||
Series A convertible preferred stock; 300,000 shares designated as Series A; 0 shares
issued and outstanding
|
-
|
-
|
||||||
Series B convertible preferred stock; 300,000 shares designated as Series B; 0 shares
issued and outstanding
|
-
|
-
|
||||||
Common stock, $0.01 par value, 120,000,000 shares authorized; 65,837,894 and 64,505,889 shares issued and
outstanding at June 30, 2022
and December 31, 2021, respectively
|
658
|
645
|
||||||
Additional paid-in capital
|
977,099
|
946,152
|
||||||
Accumulated other comprehensive loss
|
(765
|
)
|
(161
|
)
|
||||
Accumulated deficit
|
(589,296
|
)
|
(491,912
|
)
|
||||
Total stockholders’ equity
|
387,696
|
454,724
|
||||||
Total liabilities and stockholders’ equity
|
$
|
431,852
|
$
|
497,020
|
|
Three Months Ended June 30,
|
Six Months Ended
June 30,
|
||||||||||||||
|
2022
|
2021
|
2022
|
2021
|
||||||||||||
|
||||||||||||||||
Revenue
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
-
|
||||||||
|
||||||||||||||||
Operating expenses:
|
||||||||||||||||
Research and development
|
41,356
|
24,530
|
72,150
|
52,839
|
||||||||||||
General and administrative
|
12,854
|
9,518
|
24,624
|
20,431
|
||||||||||||
Total operating expenses
|
54,210
|
34,048
|
96,774
|
73,270
|
||||||||||||
Loss from operations
|
(54,210
|
)
|
(34,048
|
)
|
(96,774
|
)
|
(73,270
|
)
|
||||||||
Research and development incentives
|
-
|
-
|
-
|
500
|
||||||||||||
Interest expense
|
(465
|
)
|
(251
|
)
|
(928
|
)
|
(1,980
|
)
|
||||||||
Interest and other income, net
|
669
|
501
|
1,291
|
1,412
|
||||||||||||
Amortization of premium on investments - net
|
(396
|
)
|
(727
|
)
|
(973
|
)
|
(1,366
|
)
|
||||||||
Net loss
|
$
|
(54,402
|
)
|
$
|
(34,525
|
)
|
$
|
(97,384
|
)
|
$
|
(74,704
|
)
|
||||
Net loss per share attributable to common stockholders - basic and diluted
|
$
|
(0.83
|
)
|
$
|
(0.55
|
)
|
$
|
(1.50
|
)
|
$
|
(1.20
|
)
|
||||
Weighted-average common shares outstanding - basic and diluted
|
65,476,531
|
63,061,232
|
64,995,797
|
62,321,926
|
|
Three Months Ended June 30,
|
Six Months Ended
June 30,
|
||||||||||||||
|
2022
|
2021
|
2022
|
2021
|
||||||||||||
|
||||||||||||||||
Net loss
|
$
|
(54,402
|
)
|
$
|
(34,525
|
)
|
$
|
(97,384
|
)
|
$
|
(74,704
|
)
|
||||
Other comprehensive loss
|
||||||||||||||||
Net unrealized loss on investments
|
(136
|
)
|
(6
|
)
|
(604
|
)
|
(39
|
)
|
||||||||
Total comprehensive loss
|
$
|
(54,538
|
)
|
$
|
(34,531
|
)
|
$
|
(97,988
|
)
|
$
|
(74,743
|
)
|
Common Stock |
Additional
Paid-In
|
Accumulated
Other
Comprehensive
|
Accumulated |
Total
Stockholders'
|
||||||||||||||||||||
Shares
|
Amount
|
Capital
|
Income/(Loss)
|
Deficit
|
Equity
|
|||||||||||||||||||
Balance at December 31, 2021
|
64,505,889
|
$
|
645
|
$
|
946,152
|
$
|
(161
|
)
|
$
|
(491,912
|
)
|
$
|
454,724
|
|||||||||||
Issuance of common stock pursuant to exercise of stock options and restricted stock units
|
16,168
|
-
|
76
|
-
|
-
|
76
|
||||||||||||||||||
Unrealized comprehensive loss on investments
|
-
|
-
|
-
|
(468
|
)
|
-
|
(468
|
)
|
||||||||||||||||
Share-based compensation
|
-
|
-
|
6,270
|
-
|
-
|
6,270
|
||||||||||||||||||
Net loss
|
-
|
-
|
-
|
-
|
(42,982
|
)
|
(42,982
|
)
|
||||||||||||||||
Balance at March 31, 2022
|
64,522,057
|
645
|
952,498
|
(629
|
)
|
(534,894
|
)
|
417,620
|
||||||||||||||||
Issuance of common stock pursuant to exercise of stock options
|
2,387
|
-
|
3
|
-
|
-
|
3
|
||||||||||||||||||
Issuance of common stock pursuant to the at-the-market offering program, net of issuance costs
|
1,313,450
|
13
|
17,229
|
-
|
-
|
17,242
|
||||||||||||||||||
Unrealized comprehensive loss on marketable securities
|
-
|
-
|
-
|
(136
|
)
|
-
|
(136
|
)
|
||||||||||||||||
Share-based compensation
|
-
|
-
|
7,369
|
-
|
-
|
7,369
|
||||||||||||||||||
Net loss
|
-
|
-
|
-
|
-
|
(54,402
|
)
|
(54,402
|
)
|
||||||||||||||||
Balance at June 30, 2022
|
65,837,894
|
$
|
658
|
$
|
977,099
|
$
|
(765
|
)
|
$
|
(589,296
|
)
|
$
|
387,696
|
Common Stock |
Additional
Paid-In
|
Accumulated
Other
Comprehensive
|
Accumulated |
Total
Stockholders'
|
||||||||||||||||||||
Shares | Amount | Capital |
Loss
|
Deficit | Equity | |||||||||||||||||||
Balance at December 31, 2020
|
60,996,367
|
$
|
610
|
$
|
825,794
|
$
|
(42
|
)
|
$
|
(322,843
|
)
|
$
|
503,519
|
|||||||||||
Issuance of common stock pursuant to exercise of stock options
|
991,432
|
9
|
8,783
|
-
|
-
|
8,792
|
||||||||||||||||||
Unrealized comprehensive loss on investments
|
-
|
-
|
-
|
(33
|
)
|
-
|
(33
|
)
|
||||||||||||||||
Share-based compensation
|
-
|
-
|
7,900
|
-
|
-
|
7,900
|
||||||||||||||||||
Net loss
|
-
|
-
|
-
|
-
|
(40,179
|
)
|
(40,179
|
)
|
||||||||||||||||
Balance at March 31, 2021
|
61,987,799
|
619
|
842,477
|
(75
|
)
|
(363,022
|
)
|
479,999
|
||||||||||||||||
Issuance of common stock pursuant to exercise of stock options
|
133,838
|
2
|
1,113
|
-
|
-
|
1,115
|
||||||||||||||||||
Issuance of common stock pursuant to conversion of notes
|
1,326,432
|
13
|
35,530
|
-
|
-
|
35,543
|
||||||||||||||||||
Unrealized comprehensive loss on investments
|
-
|
-
|
-
|
(6
|
)
|
-
|
(6
|
)
|
||||||||||||||||
Share-based compensation
|
-
|
-
|
7,311
|
-
|
-
|
7,311
|
||||||||||||||||||
Net loss
|
-
|
-
|
-
|
-
|
(34,525
|
)
|
(34,525
|
)
|
||||||||||||||||
Balance at June 30, 2021
|
63,448,069
|
$
|
634
|
$
|
886,431
|
$
|
(81
|
)
|
$
|
(397,547
|
)
|
$
|
489,437
|
Six Months Ended
June 30,
|
||||||||
2022
|
2021
|
|||||||
Operating Activities:
|
||||||||
Net loss
|
$
|
(97,384
|
)
|
$
|
(74,704
|
)
|
||
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||
Accretion of discount on convertible notes
|
-
|
705
|
||||||
Depreciation and amortization of property and equipment
|
1,798
|
1,380
|
||||||
Right of use asset
|
1,070 | - | ||||||
Write down of property and equipment, net
|
177
|
-
|
||||||
Stock-based compensation
|
13,639
|
15,211
|
||||||
Accretion of discount on investments, net
|
977 | 1,345 | ||||||
Unrealized loss on marketable securities
|
- | 1 | ||||||
Changes in operating assets and liabilities:
|
||||||||
Prepaid expenses and other assets
|
(1,084
|
)
|
1,030
|
|||||
Accounts payable and accrued expenses
|
2,548
|
(8,982
|
)
|
|||||
Operating lease liabilities
|
(64
|
)
|
50
|
|||||
Finance lease liability
|
90
|
1,184
|
||||||
Other long term liabilities
|
(29
|
)
|
(29
|
)
|
||||
Net cash used in operating activities
|
(78,262
|
)
|
(62,809
|
)
|
||||
Investing activities:
|
||||||||
Purchases of investments
|
(143,023
|
)
|
(158,571
|
)
|
||||
Proceeds from maturities of investments
|
163,669
|
180,584
|
||||||
Payments made to acquire right of use asset |
- | (61 | ) | |||||
Purchases of property and equipment
|
(4,852
|
)
|
(1,774
|
)
|
||||
Net cash provided by investing activities
|
15,794
|
20,178
|
||||||
Financing activities:
|
||||||||
Issuance of common stock, pursuant to exercise of stock options
|
79
|
9,907
|
||||||
Issuance of common stock pursuant to the at-the-market offering program, net of issuance costs
|
17,243 | - | ||||||
Net cash provided by financing activities
|
17,322
|
9,907
|
||||||
Net change in cash, cash equivalents and restricted cash
|
(45,146
|
)
|
(32,724
|
)
|
||||
Cash, cash equivalents and restricted cash at beginning of period
|
234,037
|
298,666
|
||||||
Cash, cash equivalents and restricted cash at end of period
|
$
|
188,891
|
$
|
265,942
|
||||
Supplemental disclosure of non-cash financing and investing activities:
|
||||||||
Accrued purchases of property and equipment
|
$
|
405
|
$
|
1,394
|
||||
Unrealized loss on investments
|
$
|
(604
|
)
|
$
|
(39
|
)
|
||
Conversion of convertible notes into common stock |
$ |
- | $ |
35,544 | ||||
Reclassification of construction in process from finance right of use asset
|
$
|
-
|
$
|
(5
|
)
|
|||
Supplemental cash flow information:
|
||||||||
Cash paid for interest
|
$
|
-
|
$
|
1,347
|
1. |
Nature of Business
|
2. |
Risks and Liquidity
|
3. |
Basis of Presentation, Principles of Consolidation and Summary of Significant Accounting Policies
|
|
June 30,
2022
|
December 31,
2021
|
||||||
|
||||||||
Cash and cash equivalents
|
$
|
187,548
|
$
|
232,694
|
||||
Restricted cash
|
1,343
|
1,343
|
||||||
|
$
|
188,891
|
$
|
234,037
|
4. |
Fair Value of Financial Instruments
|
Fair Value Measurements as of
June 30,
2022 Using:
|
||||||||||||||||
|
Level 1
|
Level 2
|
Level 3
|
Total
|
||||||||||||
Assets:
|
||||||||||||||||
Cash equivalents:
|
||||||||||||||||
Money market mutual funds
|
$
|
142,290
|
$
|
-
|
$
|
-
|
$
|
142,290
|
||||||||
142,290
|
-
|
-
|
142,290
|
|||||||||||||
|
||||||||||||||||
Investments:
|
||||||||||||||||
United States Treasury securities
|
80,793
|
-
|
-
|
80,793
|
||||||||||||
Corporate Bonds
|
-
|
53,027
|
-
|
53,027
|
||||||||||||
80,793
|
53,027
|
-
|
133,820
|
|||||||||||||
|
||||||||||||||||
|
$
|
223,083
|
$
|
53,027
|
$
|
-
|
$
|
276,110
|
Fair Value Measurements as of
December 31, 2021 Using:
|
||||||||||||||||
|
Level 1
|
Level 2
|
Level 3
|
Total
|
||||||||||||
Assets:
|
||||||||||||||||
Cash equivalents:
|
||||||||||||||||
Money market mutual funds
|
$
|
179,900
|
$
|
-
|
$
|
-
|
$
|
179,900
|
||||||||
|
179,900
|
-
|
-
|
179,900
|
||||||||||||
|
||||||||||||||||
Investments:
|
||||||||||||||||
United States Treasury securities
|
44,045
|
-
|
-
|
44,045
|
||||||||||||
Corporate Bonds
|
-
|
96,696
|
-
|
96,696
|
||||||||||||
Municipal Bonds
|
-
|
6,000
|
-
|
6,000
|
||||||||||||
Agency Bonds
|
-
|
9,305
|
-
|
9,305
|
||||||||||||
44,045
|
112,001
|
-
|
156,046
|
|||||||||||||
|
$
|
223,945
|
$
|
112,001
|
$
|
-
|
$
|
335,946
|
5. |
Property and Equipment, Net
|
|
June 30,
2022
|
December 31,
2021
|
||||||
Laboratory equipment
|
$
|
16,349
|
$
|
12,600
|
||||
Machinery and equipment
|
10,692
|
10,432
|
||||||
Computer equipment
|
244
|
218
|
||||||
Furniture and fixtures
|
2,123
|
1,963
|
||||||
Leasehold improvements
|
458
|
407
|
||||||
Internal use software
|
1,936
|
1,902
|
||||||
|
31,802
|
27,522
|
||||||
Less: accumulated depreciation and amortization
|
(6,951
|
)
|
(5,223
|
)
|
||||
|
$
|
24,851
|
$
|
22,299
|
6. |
Accounts Payable and Accrued Expenses
|
June 30,
2022
|
December 31,
2021
|
|||||||
Research and development
|
$
|
15,926
|
$
|
12,082
|
||||
Property and equipment
|
405
|
725
|
||||||
Employee compensation
|
3,007
|
4,533
|
||||||
Government grant payable
|
597
|
597
|
||||||
Professional fees
|
1,260
|
1,196
|
||||||
Other
|
645
|
482
|
||||||
|
$
|
21,840
|
$
|
19,615
|
7. |
Stockholders’ Equity
|
8. |
Stock Based Compensation
|
Six
Months Ended June 30,
|
||||||||
|
2022
|
2021
|
||||||
|
||||||||
Risk-free interest rate
|
2.32
|
%
|
0.74
|
%
|
||||
Expected term (in years)
|
5.79
|
5.84
|
||||||
Expected volatility
|
73.26
|
%
|
69.19
|
%
|
||||
Expected dividend yield
|
0.00
|
%
|
0.00
|
%
|
||||
Exercise price
|
$
|
15.93
|
$
|
57.18
|
||||
Fair value of common stock
|
$
|
15.93
|
$
|
57.18
|
|
Number of
Shares
|
Weighted
Average
Exercise
Price
|
Weighted
Average
Contractual
Term (Years)
|
Aggregate
Intrinsic
Value
|
||||||||||||
|
||||||||||||||||
Outstanding as of December 31, 2021
|
11,143,761
|
$
|
14.51
|
5.95
|
$
|
128,817
|
||||||||||
Granted
|
1,896,748
|
15.93
|
7.13
|
|||||||||||||
Exercised
|
(8,387
|
)
|
9.39
|
$ |
49
|
|||||||||||
Forfeited
|
(505,371
|
)
|
33.65
|
|||||||||||||
Outstanding as of June 30, 2022
|
12,526,751
|
$
|
13.96
|
5.85
|
$
|
72,718
|
||||||||||
|
||||||||||||||||
Options vested and exercisable as of June 30, 2022
|
9,468,501
|
$
|
10.21
|
4.76
|
$
|
71,260
|
||||||||||
Options unvested as of June 30, 2022
|
3,059,712
|
$
|
25.53
|
9.21
|
Number of
Shares
|
Weighted
Average
Grant Date
Fair Value
|
|||||||
Unvested as of December 31, 2021
|
23,500
|
$
|
30.61
|
|||||
Granted
|
552,483
|
$ |
16.35
|
|||||
Exercised
|
(10,168 | ) | $ |
62.32 | ||||
Forfeited
|
(38,511 | ) | $ |
16.67 | ||||
Unvested as of June 30, 2022
|
527,304
|
$ |
16.55
|
Three Months Ended June 30,
|
Six
Months Ended June 30,
|
|||||||||||||||
|
2022
|
2021
|
2022
|
2021
|
||||||||||||
Stock options
|
$
|
6,677
|
$
|
7,215
|
$
|
12,638
|
$
|
15,041
|
||||||||
Restricted stock units
|
692
|
96
|
1,001
|
170
|
||||||||||||
Total stock-based compensation expense
|
$
|
7,369
|
$
|
7,311
|
$
|
13,639
|
$
|
15,211
|
Three Months Ended June 30,
|
Six Months Ended
June 30,
|
|||||||||||||||
|
2022
|
2021
|
2022
|
2021
|
||||||||||||
|
||||||||||||||||
Research and development
|
$
|
2,889
|
$
|
3,148
|
$
|
5,207
|
$
|
6,064
|
||||||||
General and administrative
|
4,480
|
4,163
|
8,432
|
9,147
|
||||||||||||
Total stock-based compensation expense
|
$
|
7,369
|
$
|
7,311
|
$
|
13,639
|
$
|
15,211
|
Exercise Price
|
Outstanding
|
Grant Date
|
Expiration Date
|
||||||
24.42
|
7,051
|
June 28, 2013
|
June 28, 2023
|
||||||
57.11
|
603,386
|
December 21, 2020
|
December 21, 2030
|
||||||
33.63
|
301,291
|
August 9, 2021
|
August 9, 2031
|
||||||
22.51
|
153,155
|
December 17, 2021
|
December 17, 2031
|
||||||
22.51
|
153,155
|
December 17, 2021
|
December 17, 2031
|
||||||
Total |
1,218,038
|
Number of
Warrant Shares
Outstanding and
Exercisable
|
Exercise
Price per
Share
|
|||||||
Balance as of December 31, 2021
|
1,218,038
|
|||||||
Granted
|
-
|
$
|
-
|
|||||
Exercised
|
-
|
$
|
-
|
|||||
Balance as of June 30, 2022
|
1,218,038
|
9. |
Net Loss Per Share
|
|
Three Months Ended June 30,
|
Six Months Ended
June 30,
|
||||||||||||||
|
2022
|
2021
|
2022
|
2021
|
||||||||||||
|
||||||||||||||||
Numerator:
|
||||||||||||||||
Net loss attributable to
common stockholders
|
$
|
(54,402
|
)
|
$
|
(34,525
|
)
|
$
|
(97,384
|
)
|
$
|
(74,704
|
)
|
||||
Denominator:
|
||||||||||||||||
Weighted-average common shares outstanding - basic and diluted
|
65,476,531
|
63,061,232
|
64,995,797
|
62,321,926
|
||||||||||||
Net loss per share attributable to
common stockholders - basic and diluted
|
$
|
(0.83
|
)
|
$
|
(0.55
|
)
|
$
|
(1.50
|
)
|
$
|
(1.20
|
)
|
|
Three and Six
Months Ended June 30,
|
|||||||
|
2022
|
2021
|
||||||
Shares issuable upon conversion of the 2021 Convertible Notes
|
-
|
160,536
|
||||||
Warrants exercisable for common shares
|
1,218,038
|
610,437
|
||||||
Restricted stock units exercisable for common shares
|
527,304
|
23,500
|
||||||
Options to purchase common shares
|
12,526,751
|
11,040,697
|
||||||
|
14,272,093
|
11,835,170
|
10. |
Commitments and Contingencies
|
Lease cost
|
June 30, 2022
|
|||
Operating lease cost
|
$
|
394
|
||
Finance lease cost
|
||||
Amortization of right of use assets
|
1,070
|
|||
Interest on lease liablities
|
929
|
|||
Total lease cost
|
$
|
2,393
|
Maturity
of operating lease liabilities
|
June 30, 2022
|
|||
2022
|
|
459
|
||
2023
|
548
|
|||
2024
|
269
|
|||
2025
|
64
|
|||
2026 | 55 | |||
Total lease payments
|
$
|
1,395
|
||
Less: interest
|
(52
|
)
|
||
Total operating lease
liabilities
|
$
|
1,343
|
Maturity of finance lease liability
|
June 30, 2022
|
|||
2022
|
|
850
|
||
2023
|
1,736
|
|||
2024
|
1,791
|
|||
2025
|
1,856
|
|||
2026
|
1,912
|
|||
Thereafter
|
45,001
|
|||
Total lease payments
|
$
|
53,146
|
||
Less: interest
|
(32,224
|
)
|
||
Total finance lease liability
|
$
|
20,922
|
Leases
|
June 30, 2022
|
|||
|
||||
Operating right-of-use assets
|
$
|
1,207
|
||
|
||||
Operating current lease liabilities
|
737
|
|||
Operating noncurrent lease liabilities
|
606
|
|||
Total operating lease liabilities
|
$
|
1,343
|
||
|
||||
Finance right-of-use assets
|
$
|
47,410
|
||
Finance current lease liability
|
1,712
|
|||
Finance noncurrent lease liability
|
19,210
|
|||
Total finance lease liability
|
$
|
20,922
|
11. |
Agreements Related to Intellectual Property
|
12. |
CIRM Grants
|
13. |
Related Party Transactions
|
14. |
401(k) Savings Plan
|
Item 2.
|
Management’s Discussion and Analysis of Financial Condition and Results of Operations
|
• |
Analysis of the explanted heart revealed significant fibrosis consistent with advanced DD.
|
• |
Myocardial tissue from the explanted heart at 5 months post-treatment displayed 100% LAMP2B protein expression by immunohistochemistry throughout non-fibrotic cardiac regions including the ventricles and other essential targeted areas
|
• |
expenses incurred under agreements with research institutions and consultants that conduct R&D activities including process development, preclinical, and clinical activities on our behalf;
|
• |
costs related to process development, production of preclinical and clinical materials, including fees paid to contract manufacturers and manufacturing input costs for use in internal manufacturing processes;
|
• |
consultants supporting process development and regulatory activities;
|
• |
patent fees; and
|
• |
costs related to in-licensing of rights to develop and commercialize our product candidate portfolio.
|
• |
salaries and personnel-related costs, including benefits, travel, and stock-based compensation, for our scientific personnel performing R&D activities;
|
• |
facilities and other expenses, which include expenses for rent and maintenance of facilities, and depreciation expense; and
|
• |
laboratory supplies and equipment used for internal R&D activities.
|
Three Months Ended June 30,
|
Six Months Ended June 30,
|
|||||||||||||||
2022
|
2021
|
2022
|
2021
|
|||||||||||||
Direct Expenses:
|
||||||||||||||||
Danon Disease (AAV) RP-A501
|
$
|
9,568
|
$
|
4,507
|
$
|
15,942
|
$
|
8,307
|
||||||||
Leukocyte Adhesion Deficiency (LVV) RP-L201
|
7,044
|
3,864
|
10,095
|
10,270
|
||||||||||||
Fanconi Anemia (LVV) RP-L102
|
4,557
|
2,013
|
9,087
|
5,608
|
||||||||||||
Pyruvate Kinase Deficiency (LVV) RP-L301
|
632
|
562
|
1,486
|
2,421
|
||||||||||||
Infantile Malignant Osteopetrosis (LVV) RP-L401 (1)
|
-
|
449
|
190
|
1,245
|
||||||||||||
Other product candidates
|
3,776
|
1,179
|
7,030
|
1,871
|
||||||||||||
Total direct expenses
|
25,577
|
12,574
|
43,830
|
29,722
|
||||||||||||
Unallocated Expenses
|
||||||||||||||||
Employee compensation
|
$
|
6,964
|
$
|
5,078
|
$
|
12,511
|
$
|
9,741
|
||||||||
Stock based compensation expense
|
2,889
|
3,148
|
5,207
|
6,064
|
||||||||||||
Depreciation and amortization expense
|
1,060
|
1,194
|
1,887
|
2,370
|
||||||||||||
Laboratory and related expenses
|
1,291
|
835
|
2,518
|
1,482
|
||||||||||||
Legal and patent fees
|
-
|
(16
|
)
|
-
|
41
|
|||||||||||
Professional Fees
|
629
|
358
|
1,190
|
827
|
||||||||||||
Other expenses
|
2,946
|
1,359
|
5,007
|
2,592
|
||||||||||||
Total other research and development expenses
|
15,779
|
11,956
|
28,320
|
23,117
|
||||||||||||
Total research and development expense
|
$
|
41,356
|
$
|
24,530
|
$
|
72,150
|
$
|
52,839
|
(1) |
Effective December 2021, a decision was made to no longer pursue Rocket-sponsored clinical evaluation of RP-L401; this program was returned to academic innovators.
|
• |
the scope, rate of progress, and expense of ongoing as well as any clinical studies and other R&D activities that we undertake;
|
• |
future clinical study results;
|
• |
uncertainties in clinical study enrollment rates;
|
• |
changing standards for regulatory approval; and
|
• |
the timing and receipt of any regulatory approvals.
|
• |
the scope, progress, outcome and costs of our clinical trials and other R&D activities;
|
• |
the efficacy and potential advantages of our product candidates compared to alternative treatments, including any standard of care;
|
• |
the market acceptance of our product candidates;
|
• |
obtaining, maintaining, defending, and enforcing patent claims and other intellectual property rights;
|
• |
significant and changing government regulation; and
|
• |
the timing, receipt, and terms of any marketing approvals.
|
Three Months Ended June 30,
|
||||||||||||
2022
|
2021
|
Change
|
||||||||||
Operating expenses:
|
||||||||||||
Research and development
|
$
|
41,356
|
$
|
24,530
|
$
|
16,826
|
||||||
General and administrative
|
12,854
|
9,518
|
3,336
|
|||||||||
Total operating expenses
|
54,210
|
34,048
|
20,162
|
|||||||||
Loss from operations
|
(54,210
|
)
|
(34,048
|
)
|
(20,162
|
)
|
||||||
Research and development incentives
|
-
|
-
|
-
|
|||||||||
Interest expense
|
(465
|
)
|
(251
|
)
|
(214
|
)
|
||||||
Interest and other income, net
|
669
|
501
|
168
|
|||||||||
Amortization of premium on investments - net
|
(396
|
)
|
(727
|
)
|
331
|
|||||||
Total other expense, net
|
(192
|
)
|
(477
|
)
|
285
|
|||||||
Net loss
|
$
|
(54,402
|
)
|
$
|
(34,525
|
)
|
$
|
(19,877
|
)
|
Six Months Ended June 30,
|
||||||||||||
2022
|
2021
|
Change
|
||||||||||
Operating expenses:
|
||||||||||||
Research and development
|
$
|
72,150
|
$
|
52,839
|
$
|
19,311
|
||||||
General and administrative
|
24,624
|
$
|
20,431
|
4,193
|
||||||||
Total operating expenses
|
96,774
|
73,270
|
23,504
|
|||||||||
Loss from operations
|
(96,774
|
)
|
(73,270
|
)
|
(23,504
|
)
|
||||||
Research and development incentives
|
-
|
500
|
(500
|
)
|
||||||||
Interest expense
|
(928
|
)
|
(1,980
|
)
|
1,052
|
|||||||
Interest and other income, net
|
1,291
|
1,412
|
(121
|
)
|
||||||||
Amortization of premium on investments - net
|
(973
|
)
|
(1,366
|
)
|
393
|
|||||||
Total other expense, net
|
(610
|
)
|
(1,434
|
)
|
824
|
|||||||
Net loss
|
$
|
(97,384
|
)
|
$
|
(74,704
|
)
|
$
|
(22,680
|
)
|
Six Months Ended June 30,
|
||||||||
2022
|
2021
|
|||||||
Cash used in operating activities
|
$
|
(78,262
|
)
|
$
|
(62,809
|
)
|
||
Cash provided by investing activities
|
15,794
|
20,178
|
||||||
Cash provided by financing activities
|
17,322
|
9,907
|
||||||
Net change in cash, cash equivalents and restricted cash
|
$
|
(45,146
|
)
|
$
|
(32,724
|
)
|
• |
finance unanticipated working capital requirements;
|
• |
continue to advance our product candidates through clinical development;
|
• |
continue our efforts to expand our pipeline of development programs;
|
• |
develop proprietary in-house analytics and manufacturing capabilities;
|
• |
pursue acquisitions or other strategic relationships; and
|
• |
respond to competitive pressures.
|
ROCKET PHARMACEUTICALS, INC.
|
||
August 9, 2022
|
By:
|
/s/ Gaurav Shah, MD
|
Gaurav Shah, MD
|
||
Chief Executive Officer and Director
|
||
(Principal Executive Officer)
|
||
August 9, 2022
|
By:
|
/s/ John Militello
|
John Militello
|
||
VP of Finance, Senior Controller and Treasurer
|
||
(Interim Principal Financial Officer and Principal Accounting Officer)
|
1 Year Rocket Pharmaceuticals Chart |
1 Month Rocket Pharmaceuticals Chart |
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