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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Moderna Inc | NASDAQ:MRNA | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
-0.23 | -0.18% | 125.36 | 116.45 | 129.00 | 126.3843 | 122.01 | 125.06 | 4,513,134 | 05:00:04 |
FORM 10-Q
|
Delaware
|
|
81-3467528
|
(State or Other Jurisdiction of Incorporation or Organization)
|
|
(IRS Employer Identification No.)
|
|
|
|
200 Technology Square
Cambridge, Massachusetts
|
|
02139
|
(Address of Principal Executive Offices)
|
|
(Zip Code)
|
Title of each class
|
Trading symbol(s)
|
Name of each exchange on which registered
|
Common stock, par value $0.0001 per share
|
MRNA
|
The NASDAQ Stock Market LLC
|
Large accelerated filer
o
|
|
Accelerated filer
o
|
|
Non-accelerated filer
x
|
|
Smaller reporting company
o
|
|
|
|
|
|
|
Emerging growth company
x
|
•
|
the initiation, timing, progress, results, safety and efficacy, and cost of our research and development programs and our current and future preclinical studies and clinical trials, including statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available, and our research and development programs;
|
•
|
our ability to identify research priorities and apply a risk-mitigated strategy to efficiently discover and develop development candidates and investigational medicines, including by applying learnings from one program to our other programs and from one modality to our other modalities;
|
•
|
our ability and the potential to successfully manufacture our drug substances, delivery vehicles, development candidates, and investigational medicines for preclinical use, for clinical trials and on a larger scale for commercial use, if approved;
|
•
|
the ability and willingness of our third-party strategic collaborators to continue research and development activities relating to our development candidates and investigational medicines;
|
•
|
our ability to obtain funding for our operations necessary to complete further development and commercialization of our investigational medicines;
|
•
|
our ability to obtain and maintain regulatory approval of our investigational medicines;
|
•
|
our ability to commercialize our products, if approved;
|
•
|
the pricing and reimbursement of our investigational medicines, if approved;
|
•
|
the implementation of our business model, and strategic plans for our business, investigational medicines, and technology;
|
•
|
the scope of protection we are able to establish and maintain for intellectual property rights covering our investigational medicines and technology;
|
•
|
estimates of our future expenses, revenues, capital requirements, and our needs for additional financing;
|
•
|
the potential benefits of strategic collaboration agreements, our ability to enter into strategic collaborations or arrangements, and our ability to attract collaborators with development, regulatory, and commercialization expertise;
|
•
|
future agreements with third parties in connection with the commercialization of our investigational medicines, if approved;
|
•
|
the size and growth potential of the markets for our investigational medicines, and our ability to serve those markets;
|
•
|
our financial performance;
|
•
|
the rate and degree of market acceptance of our investigational medicines;
|
•
|
regulatory developments in the United States and foreign countries;
|
•
|
our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately;
|
•
|
our ability to produce our products or investigational medicines with advantages in turnaround times or manufacturing cost;
|
•
|
the success of competing therapies that are or may become available;
|
•
|
our ability to attract and retain key scientific or management personnel;
|
•
|
the impact of laws and regulations;
|
•
|
developments relating to our competitors and our industry; and
|
•
|
other risks and uncertainties, including those discussed in Part II, Item 1A - Risk Factors in this Form 10-Q.
|
PART I
.
|
|
Page
|
Item 1.
|
||
|
||
|
||
|
||
|
||
|
||
|
||
Item 2.
|
||
Item 3.
|
||
Item 4.
|
||
PART II
.
|
|
|
Item 1.
|
||
Item 1A.
|
||
Item 2
|
||
Item 6.
|
||
|
|
|
June 30,
|
|
December 31,
|
||||
|
2019
|
|
2018
|
||||
Assets
|
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
151,624
|
|
|
$
|
658,364
|
|
Investments
|
918,722
|
|
|
863,063
|
|
||
Accounts receivable
|
3,498
|
|
|
11,686
|
|
||
Accounts receivable from related party
|
1,020
|
|
|
899
|
|
||
Prepaid expenses and other current assets
|
22,492
|
|
|
28,399
|
|
||
Restricted cash
|
62
|
|
|
595
|
|
||
Total current assets
|
1,097,418
|
|
|
1,563,006
|
|
||
Investments, non-current
|
365,032
|
|
|
172,990
|
|
||
Property and equipment, net
|
208,509
|
|
|
211,977
|
|
||
Restricted cash, non-current
|
11,762
|
|
|
11,532
|
|
||
Other non-current assets
|
2,558
|
|
|
2,644
|
|
||
Total assets
|
$
|
1,685,279
|
|
|
$
|
1,962,149
|
|
Liabilities and Stockholders’ Equity
|
|
|
|
||||
Current liabilities:
|
|
|
|
||||
Accounts payable
|
$
|
29,609
|
|
|
$
|
31,210
|
|
Accrued liabilities
|
44,589
|
|
|
79,073
|
|
||
Deferred revenue
|
83,401
|
|
|
109,056
|
|
||
Other current liabilities
|
4,388
|
|
|
3,464
|
|
||
Total current liabilities
|
161,987
|
|
|
222,803
|
|
||
Deferred revenue, non-current
|
139,923
|
|
|
165,352
|
|
||
Deferred lease obligation, non-current
|
11,039
|
|
|
10,006
|
|
||
Lease financing obligation
|
33,588
|
|
|
33,489
|
|
||
Other non-current liabilities
|
188
|
|
|
258
|
|
||
Total liabilities
|
346,725
|
|
|
431,908
|
|
||
Commitments and contingencies (Note 7)
|
|
|
|
||||
Stockholders’ equity:
|
|
|
|
||||
Preferred stock, par value $0.0001; 162,000,000 shares authorized as of June 30, 2019
and December 31, 2018; no shares issued or outstanding at June 30, 2019 and
December 31, 2018
|
—
|
|
|
—
|
|
||
Common stock, par value $0.0001; 1,600,000,000 shares authorized as of June 30, 2019 and December 31, 2018; 329,958,172 and 328,798,904 shares issued and outstanding as of June 30, 2019 and December 31, 2018, respectively
|
33
|
|
|
33
|
|
||
Additional paid-in capital
|
2,582,134
|
|
|
2,538,155
|
|
||
Accumulated other comprehensive income (loss)
|
2,741
|
|
|
(1,320
|
)
|
||
Accumulated deficit
|
(1,246,354
|
)
|
|
(1,006,627
|
)
|
||
Total stockholders’ equity
|
1,338,554
|
|
|
1,530,241
|
|
||
Total liabilities and stockholders’ equity
|
$
|
1,685,279
|
|
|
$
|
1,962,149
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Revenue:
|
|
|
|
|
|
|
|
||||||||
Collaboration revenue
|
$
|
9,842
|
|
|
$
|
19,742
|
|
|
$
|
23,143
|
|
|
$
|
39,852
|
|
Collaboration revenue from related party
|
188
|
|
|
6,089
|
|
|
1,002
|
|
|
13,439
|
|
||||
Grant revenue
|
3,053
|
|
|
3,020
|
|
|
4,963
|
|
|
4,599
|
|
||||
Total revenue
|
13,083
|
|
|
28,851
|
|
|
29,108
|
|
|
57,890
|
|
||||
Operating expenses:
|
|
|
|
|
|
|
|
||||||||
Research and development
|
128,496
|
|
|
104,479
|
|
|
259,071
|
|
|
194,603
|
|
||||
General and administrative
|
28,523
|
|
|
21,387
|
|
|
55,806
|
|
|
37,704
|
|
||||
Total operating expenses
|
157,019
|
|
|
125,866
|
|
|
314,877
|
|
|
232,307
|
|
||||
Loss from operations
|
(143,936
|
)
|
|
(97,015
|
)
|
|
(285,769
|
)
|
|
(174,417
|
)
|
||||
Interest income
|
10,322
|
|
|
6,401
|
|
|
21,294
|
|
|
11,610
|
|
||||
Other (expense) income, net
|
(1,764
|
)
|
|
171
|
|
|
(3,584
|
)
|
|
(12
|
)
|
||||
Loss before income taxes
|
(135,378
|
)
|
|
(90,443
|
)
|
|
(268,059
|
)
|
|
(162,819
|
)
|
||||
(Benefit from) provision for income taxes
|
(324
|
)
|
|
158
|
|
|
(348
|
)
|
|
158
|
|
||||
Net loss
|
$
|
(135,054
|
)
|
|
$
|
(90,601
|
)
|
|
$
|
(267,711
|
)
|
|
$
|
(162,977
|
)
|
Net loss attributable to common stockholders (Note 11)
|
$
|
(135,054
|
)
|
|
$
|
(94,082
|
)
|
|
$
|
(267,711
|
)
|
|
$
|
(169,939
|
)
|
Net loss per share attributable to common stockholders, basic and diluted
|
$
|
(0.41
|
)
|
|
$
|
(1.43
|
)
|
|
$
|
(0.81
|
)
|
|
$
|
(2.59
|
)
|
Weighted average common shares used in net loss per share attributable to common stockholders, basic and diluted
|
329,176,107
|
|
|
65,938,939
|
|
|
328,994,058
|
|
|
65,686,290
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Net loss
|
$
|
(135,054
|
)
|
|
$
|
(90,601
|
)
|
|
$
|
(267,711
|
)
|
|
$
|
(162,977
|
)
|
Other comprehensive income (loss):
|
|
|
|
|
|
|
|
||||||||
Unrealized gain (loss) on available-for-sale debt securities, net of tax, $608 and $0, for three months ended June 30, 2019 and 2018, respectively, and net of tax, $1,148 and $0, for six months ended June 30, 2019 and 2018, respectively
|
2,167
|
|
|
1,738
|
|
|
4,075
|
|
|
(261
|
)
|
||||
Less: amounts recognized for net realized gains included in net loss
|
(17
|
)
|
|
(597
|
)
|
|
(14
|
)
|
|
(591
|
)
|
||||
Total other comprehensive income (loss)
|
2,150
|
|
|
1,141
|
|
|
4,061
|
|
|
(852
|
)
|
||||
Comprehensive loss
|
$
|
(132,904
|
)
|
|
$
|
(89,460
|
)
|
|
$
|
(263,650
|
)
|
|
$
|
(163,829
|
)
|
|
|
Three Months Ended June 30, 2019
|
||||||||||||||||||||||||||||||
|
|
Redeemable Convertible
Preferred Stock
|
|
|
|
Common Stock
|
|
Additional
Paid-In
Capital
|
|
Accumulated
Other
Comprehensive
Income
|
|
Accumulated
Deficit
|
|
Total
Stockholders’
Equity
|
||||||||||||||||||
|
|
Shares
|
|
Amount
|
|
|
|
Shares
|
|
Amount
|
|
|
|
|
||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
Balance at March 31, 2019
|
|
—
|
|
|
$
|
—
|
|
|
|
|
328,853,340
|
|
|
$
|
33
|
|
|
$
|
2,556,709
|
|
|
$
|
591
|
|
|
$
|
(1,111,300
|
)
|
|
$
|
1,446,033
|
|
Vesting of restricted common stock
|
|
—
|
|
|
—
|
|
|
|
|
58,564
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Exercise of options to purchase common stock, net
|
|
—
|
|
|
—
|
|
|
|
|
1,046,268
|
|
|
—
|
|
|
3,930
|
|
|
—
|
|
|
—
|
|
|
3,930
|
|
||||||
Stock-based compensation
|
|
—
|
|
|
—
|
|
|
|
|
—
|
|
|
—
|
|
|
21,495
|
|
|
—
|
|
|
—
|
|
|
21,495
|
|
||||||
Unrealized gain on marketable securities
|
|
—
|
|
|
—
|
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2,150
|
|
|
—
|
|
|
2,150
|
|
||||||
Net loss
|
|
—
|
|
|
—
|
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(135,054
|
)
|
|
(135,054
|
)
|
||||||
Balance at June 30, 2019
|
|
—
|
|
|
$
|
—
|
|
|
|
|
329,958,172
|
|
|
$
|
33
|
|
|
$
|
2,582,134
|
|
|
$
|
2,741
|
|
|
$
|
(1,246,354
|
)
|
|
$
|
1,338,554
|
|
|
|
Three Months Ended June 30, 2018
|
||||||||||||||||||||||||||||||
|
|
Redeemable Convertible
Preferred Stock
|
|
|
|
Common Stock
|
|
Additional
Paid-In
Capital
|
|
Accumulated
Other
Comprehensive
Loss
|
|
Accumulated
Deficit
|
|
Total
Stockholders’
Deficit
|
||||||||||||||||||
|
|
Shares
|
|
Amount
|
|
|
|
Shares
|
|
Amount
|
|
|
|
|
||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
Balance at March 31, 2018
|
|
504,352,795
|
|
|
$
|
1,726,074
|
|
|
|
|
65,543,841
|
|
|
$
|
6
|
|
|
$
|
83,704
|
|
|
$
|
(3,150
|
)
|
|
$
|
(694,269
|
)
|
|
$
|
(613,709
|
)
|
Vesting of restricted common stock
|
|
—
|
|
|
—
|
|
|
|
|
315,276
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Exercise of options to purchase common stock, net
|
|
—
|
|
|
—
|
|
|
|
|
345,679
|
|
|
—
|
|
|
48
|
|
|
—
|
|
|
—
|
|
|
48
|
|
||||||
Issuance of Series H redeemable convertible preferred stock, net of issuance costs of $474
|
|
5,000,000
|
|
|
111,546
|
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Stock-based compensation
|
|
—
|
|
|
—
|
|
|
|
|
—
|
|
|
—
|
|
|
14,353
|
|
|
—
|
|
|
—
|
|
|
14,353
|
|
||||||
Unrealized gain on marketable securities
|
|
—
|
|
|
—
|
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,141
|
|
|
—
|
|
|
1,141
|
|
||||||
Net loss
|
|
—
|
|
|
—
|
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(90,601
|
)
|
|
(90,601
|
)
|
||||||
Balance at June 30, 2018
|
|
509,352,795
|
|
|
$
|
1,837,620
|
|
|
|
|
66,204,796
|
|
|
$
|
6
|
|
|
$
|
98,105
|
|
|
$
|
(2,009
|
)
|
|
$
|
(784,870
|
)
|
|
$
|
(688,768
|
)
|
|
|
Six Months Ended June 30, 2019
|
||||||||||||||||||||||||||||||
|
|
Redeemable Convertible
Preferred Stock
|
|
|
|
Common Stock
|
|
Additional
Paid-In
Capital
|
|
Accumulated
Other
Comprehensive
Income
|
|
Accumulated
Deficit
|
|
Total
Stockholders’
Equity
|
||||||||||||||||||
|
|
Shares
|
|
Amount
|
|
|
|
Shares
|
|
Amount
|
|
|
|
|
||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
Balance at December 31, 2018
|
|
—
|
|
|
$
|
—
|
|
|
|
|
328,798,904
|
|
|
$
|
33
|
|
|
$
|
2,538,155
|
|
|
$
|
(1,320
|
)
|
|
$
|
(1,006,627
|
)
|
|
$
|
1,530,241
|
|
Transition adjustment from adoption of ASU Topic 606 (Note 2)
|
|
|
|
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
27,984
|
|
|
27,984
|
|
||||||||
Vesting of restricted common stock
|
|
—
|
|
|
—
|
|
|
|
|
107,475
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Exercise of options to purchase common stock, net
|
|
—
|
|
|
—
|
|
|
|
|
1,051,793
|
|
|
—
|
|
|
3,987
|
|
|
—
|
|
|
—
|
|
|
3,987
|
|
||||||
Stock-based compensation
|
|
—
|
|
|
—
|
|
|
|
|
—
|
|
|
—
|
|
|
39,992
|
|
|
—
|
|
|
—
|
|
|
39,992
|
|
||||||
Unrealized gain on marketable securities
|
|
—
|
|
|
—
|
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
4,061
|
|
|
—
|
|
|
4,061
|
|
||||||
Net loss
|
|
—
|
|
|
—
|
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(267,711
|
)
|
|
(267,711
|
)
|
||||||
Balance at June 30, 2019
|
|
—
|
|
|
$
|
—
|
|
|
|
|
329,958,172
|
|
|
$
|
33
|
|
|
$
|
2,582,134
|
|
|
$
|
2,741
|
|
|
$
|
(1,246,354
|
)
|
|
$
|
1,338,554
|
|
|
|
Six Months Ended June 30, 2018
|
||||||||||||||||||||||||||||||
|
|
Redeemable Convertible
Preferred Stock
|
|
|
|
Common Stock
|
|
Additional
Paid-In
Capital
|
|
Accumulated
Other
Comprehensive
Loss
|
|
Accumulated
Deficit
|
|
Total
Stockholders’
Deficit
|
||||||||||||||||||
|
|
Shares
|
|
Amount
|
|
|
|
Shares
|
|
Amount
|
|
|
|
|
||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
Balance at December 31, 2017
|
|
448,686,791
|
|
|
$
|
1,176,661
|
|
|
|
|
65,206,999
|
|
|
$
|
6
|
|
|
$
|
71,679
|
|
|
$
|
(1,157
|
)
|
|
$
|
(621,893
|
)
|
|
$
|
(551,365
|
)
|
Vesting of restricted common stock
|
|
—
|
|
|
—
|
|
|
|
|
650,329
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Issuance of Series G redeemable convertible preferred stock, net of issuance costs of $10,517
|
|
55,666,004
|
|
|
549,413
|
|
|
|
|
—
|
|
|
—
|
|
|
152
|
|
|
—
|
|
|
—
|
|
|
152
|
|
||||||
Issuance of Series H redeemable convertible preferred stock, net of issuance costs of $474
|
|
5,000,000
|
|
|
111,546
|
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Exercise of options to purchase common stock, net
|
|
—
|
|
|
—
|
|
|
|
|
347,468
|
|
|
—
|
|
|
70
|
|
|
—
|
|
|
—
|
|
|
70
|
|
||||||
Stock-based compensation
|
|
—
|
|
|
—
|
|
|
|
|
—
|
|
|
—
|
|
|
26,204
|
|
|
—
|
|
|
—
|
|
|
26,204
|
|
||||||
Unrealized loss on marketable securities
|
|
—
|
|
|
—
|
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(852
|
)
|
|
—
|
|
|
(852
|
)
|
||||||
Net loss
|
|
—
|
|
|
—
|
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(162,977
|
)
|
|
(162,977
|
)
|
||||||
Balance at June 30, 2018
|
|
509,352,795
|
|
|
$
|
1,837,620
|
|
|
|
|
66,204,796
|
|
|
$
|
6
|
|
|
$
|
98,105
|
|
|
$
|
(2,009
|
)
|
|
$
|
(784,870
|
)
|
|
$
|
(688,768
|
)
|
|
Six Months Ended June 30,
|
||||||
|
2019
|
|
2018
|
||||
Operating activities
|
|
|
|
||||
Net loss
|
$
|
(267,711
|
)
|
|
$
|
(162,977
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
||||
Stock-based compensation
|
39,992
|
|
|
26,204
|
|
||
Depreciation and amortization
|
14,817
|
|
|
11,031
|
|
||
Amortization of investment premiums
|
(2,360
|
)
|
|
(531
|
)
|
||
Loss on disposal of property and equipment
|
14
|
|
|
—
|
|
||
Changes in assets and liabilities:
|
|
|
|
||||
Accounts receivable
|
8,188
|
|
|
489
|
|
||
Accounts receivable from related party
|
(121
|
)
|
|
766
|
|
||
Prepaid expenses and other assets
|
2,315
|
|
|
(8,872
|
)
|
||
Accounts payable
|
(1,471
|
)
|
|
(1,340
|
)
|
||
Accrued liabilities
|
(27,796
|
)
|
|
(24,959
|
)
|
||
Deferred revenue
|
(23,100
|
)
|
|
(2,283
|
)
|
||
Deferred lease obligation
|
1,033
|
|
|
2,046
|
|
||
Other liabilities
|
53
|
|
|
792
|
|
||
Net cash used in operating activities
|
(256,147
|
)
|
|
(159,634
|
)
|
||
Investing activities
|
|
|
|
||||
Purchases of marketable securities
|
(843,313
|
)
|
|
(837,984
|
)
|
||
Proceeds from maturities of marketable securities
|
563,634
|
|
|
298,376
|
|
||
Proceeds from sales of marketable securities
|
39,200
|
|
|
110,248
|
|
||
Purchases of property and equipment
|
(18,181
|
)
|
|
(65,989
|
)
|
||
Net cash used in investing activities
|
(258,660
|
)
|
|
(495,349
|
)
|
||
Financing activities
|
|
|
|
||||
Proceeds from issuance of redeemable convertible preferred stock, net of issuance costs
|
—
|
|
|
661,111
|
|
||
Proceeds from issuance of common stock through equity plans
|
3,987
|
|
|
70
|
|
||
Reimbursement of assets under lease financing obligation
|
3,678
|
|
|
1,747
|
|
||
Payments on financing lease obligation
|
99
|
|
|
(2,571
|
)
|
||
Net cash provided by financing activities
|
7,764
|
|
|
660,357
|
|
||
Net (decrease) increase in cash, cash equivalents and restricted cash
|
(507,043
|
)
|
|
5,374
|
|
||
Cash, cash equivalents and restricted cash, beginning of year
|
670,491
|
|
|
147,608
|
|
||
Cash, cash equivalents and restricted cash, end of period
|
$
|
163,448
|
|
|
$
|
152,982
|
|
Non-cash investing and financing activities
|
|
|
|
||||
Purchases of property and equipment included in accounts payable and accrued liabilities
|
$
|
6,074
|
|
|
$
|
28,181
|
|
Leasehold improvements included in prepaid and other current assets
|
$
|
6,310
|
|
|
$
|
13,567
|
|
Lease financing obligation
|
$
|
—
|
|
|
$
|
13,567
|
|
|
Unrealized Gain on Available-for-Sale Debt Securities
|
||
|
June 30, 2019
|
||
Accumulated other comprehensive loss, balance at December 31, 2018
|
$
|
(1,320
|
)
|
Other comprehensive income
|
1,911
|
|
|
Accumulated other comprehensive income, balance at March 31, 2019
|
591
|
|
|
Other comprehensive income
|
2,150
|
|
|
Accumulated other comprehensive income, balance at June 30, 2019
|
$
|
2,741
|
|
Condensed Consolidated Balance Sheet
|
|
Balance at December 31, 2018
|
|
Adjustments
|
|
Balance at
January 1, 2019
|
||||||
Deferred revenue, current
|
|
$
|
109,056
|
|
|
$
|
(27,281
|
)
|
|
$
|
81,775
|
|
Deferred revenue, non-current
|
|
165,352
|
|
|
(3,441
|
)
|
|
161,911
|
|
|||
Accounts receivable
|
|
11,686
|
|
|
(2,738
|
)
|
|
8,948
|
|
|||
Accumulated deficit
|
|
(1,006,627
|
)
|
|
27,984
|
|
|
(978,643
|
)
|
|
|
June 30, 2019
|
||||||||||
Condensed Consolidated Balance Sheet
|
|
As reported under ASC 606
|
|
Adjustments
|
|
Balance without adoption of ASC 606
|
||||||
Deferred revenue, current
|
|
$
|
83,401
|
|
|
$
|
3,266
|
|
|
$
|
86,667
|
|
Deferred revenue, non-current
|
|
139,923
|
|
|
1,936
|
|
|
141,859
|
|
|||
Accumulated deficit
|
|
(1,246,354
|
)
|
|
(1,595
|
)
|
|
(1,247,949
|
)
|
|
|
Three Months Ended June 30, 2019
|
||||||||||
Condensed Consolidated Statement of Operations
|
|
As reported under ASC 606
|
|
Adjustments
|
|
Amount without adoption of ASC 606
|
||||||
Revenue:
|
|
|
|
|
|
|
||||||
Collaboration revenue
|
|
$
|
9,842
|
|
|
$
|
3,155
|
|
|
$
|
12,997
|
|
Collaboration revenue from related party
|
|
188
|
|
|
642
|
|
|
830
|
|
|||
Total revenue
|
|
13,083
|
|
|
3,797
|
|
|
16,880
|
|
|||
Loss from operations
|
|
(143,936
|
)
|
|
3,797
|
|
|
(140,139
|
)
|
|||
Loss before income taxes
|
|
(135,378
|
)
|
|
3,797
|
|
|
(131,581
|
)
|
|||
Net loss
|
|
(135,054
|
)
|
|
3,797
|
|
|
(131,257
|
)
|
|||
Net loss per share - basic and diluted
|
|
(0.41
|
)
|
|
0.01
|
|
|
(0.40
|
)
|
|
|
Six Months Ended June 30, 2019
|
||||||||||
Condensed Consolidated Statement of Operations
|
|
As reported under ASC 606
|
|
Adjustments
|
|
Amount without adoption of ASC 606
|
||||||
Revenue:
|
|
|
|
|
|
|
||||||
Collaboration revenue
|
|
$
|
23,143
|
|
|
$
|
1,369
|
|
|
$
|
24,512
|
|
Collaboration revenue from related party
|
|
1,002
|
|
|
25,019
|
|
|
26,021
|
|
|||
Total revenue
|
|
29,108
|
|
|
26,388
|
|
|
55,496
|
|
|||
Loss from operations
|
|
(285,769
|
)
|
|
26,388
|
|
|
(259,381
|
)
|
|||
Loss before income taxes
|
|
(268,059
|
)
|
|
26,388
|
|
|
(241,671
|
)
|
|||
Net loss
|
|
(267,711
|
)
|
|
26,388
|
|
|
(241,323
|
)
|
|||
Net loss per share - basic and diluted
|
|
(0.81
|
)
|
|
0.08
|
|
|
(0.73
|
)
|
|
|
As of June 30,
|
||||||
|
|
2019
|
|
2018
|
||||
Cash and cash equivalents
|
|
$
|
151,624
|
|
|
$
|
140,619
|
|
Restricted cash
|
|
62
|
|
|
831
|
|
||
Restricted cash, non-current
|
|
11,762
|
|
|
11,532
|
|
||
Total cash, cash equivalents and restricted cash shown in the condensed consolidated
statements of cash flows
|
|
$
|
163,448
|
|
|
$
|
152,982
|
|
|
|
Three Months Ended
|
||||||||||
Collaboration Revenue by Strategic Collaborator:
|
|
June 30, 2019
as reported
(under ASU 606)
|
|
June 30, 2019
without adoption of 606
(under ASC 605)
|
|
June 30, 2018
as reported
(under ASC 605)
|
||||||
Merck
|
|
$
|
8,659
|
|
|
$
|
8,802
|
|
|
$
|
17,095
|
|
AstraZeneca
|
|
188
|
|
|
830
|
|
|
6,089
|
|
|||
Vertex
|
|
1,183
|
|
|
4,195
|
|
|
2,390
|
|
|||
Total collaboration revenue
|
|
$
|
10,030
|
|
|
$
|
13,827
|
|
|
$
|
25,574
|
|
|
|
Six Months Ended
|
||||||||||
Collaboration Revenue by Strategic Collaborator:
|
|
June 30, 2019
as reported
(under ASU 606)
|
|
June 30, 2019
without adoption of 606
(under ASC 605)
|
|
June 30, 2018
as reported
(under ASC 605)
|
||||||
Merck
|
|
$
|
19,346
|
|
|
$
|
20,317
|
|
|
$
|
33,062
|
|
AstraZeneca
|
|
1,002
|
|
|
26,021
|
|
|
13,439
|
|
|||
Vertex
|
|
3,797
|
|
|
4,195
|
|
|
6,533
|
|
|||
Total collaboration revenue
|
|
$
|
24,145
|
|
|
$
|
50,533
|
|
|
$
|
53,034
|
|
|
|
January 1, 2019
|
|
Additions
|
|
Deductions
|
|
June 30, 2019
|
||||||||
Contract Assets:
|
|
|
|
|
|
|
|
|
||||||||
Accounts receivable
|
|
$
|
4,612
|
|
|
$
|
5,110
|
|
|
$
|
(5,204
|
)
|
|
$
|
4,518
|
|
Contract Liabilities:
|
|
|
|
|
|
|
|
|
||||||||
Deferred revenue
|
|
$
|
240,924
|
|
|
$
|
2,292
|
|
|
$
|
(25,165
|
)
|
|
$
|
218,051
|
|
Revenue recognized in the period from:
|
|
Three Months Ended June 30, 2019
|
|
Six Months Ended June 30, 2019
|
||||
Amounts included in contract liabilities at the beginning of the period
(1)
|
|
$
|
11,583
|
|
|
$
|
25,165
|
|
|
|
June 30, 2019
|
||||||||||||||||||||||||||
|
|
Amortized
Cost
|
|
Unrealized
Gains
|
|
Unrealized
Losses
|
|
Fair Value
|
|
Cash and
Cash
Equivalents
|
|
Current
Marketable
Securities
|
|
Non-
Current
Marketable
Securities
|
||||||||||||||
Cash and cash equivalents
|
|
$
|
151,624
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
151,624
|
|
|
$
|
151,624
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Available-for-sale:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
Level 2:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
Certificates of deposit
|
|
136,011
|
|
|
160
|
|
|
(1
|
)
|
|
136,170
|
|
|
—
|
|
|
132,469
|
|
|
3,701
|
|
|||||||
U.S. treasury securities
|
|
153,651
|
|
|
507
|
|
|
—
|
|
|
154,158
|
|
|
—
|
|
|
129,985
|
|
|
24,173
|
|
|||||||
Debt securities of U.S. government agencies and corporate entities
|
|
990,203
|
|
|
3,275
|
|
|
(52
|
)
|
|
993,426
|
|
|
—
|
|
|
656,268
|
|
|
337,158
|
|
|||||||
|
|
$
|
1,431,489
|
|
|
$
|
3,942
|
|
|
$
|
(53
|
)
|
|
$
|
1,435,378
|
|
|
$
|
151,624
|
|
|
$
|
918,722
|
|
|
$
|
365,032
|
|
|
|
December 31, 2018
|
||||||||||||||||||||||||||
|
|
Amortized
Cost
|
|
Unrealized
Gains
|
|
Unrealized
Losses
|
|
Fair Value
|
|
Cash and
Cash
Equivalents
|
|
Current
Marketable
Securities
|
|
Non-
Current
Marketable
Securities
|
||||||||||||||
Cash and cash equivalents
|
|
$
|
658,365
|
|
|
$
|
20
|
|
|
$
|
(21
|
)
|
|
$
|
658,364
|
|
|
$
|
658,364
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Available-for-sale:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
Level 2:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
Certificates of deposit
|
|
173,102
|
|
|
42
|
|
|
(36
|
)
|
|
173,108
|
|
|
—
|
|
|
157,920
|
|
|
15,188
|
|
|||||||
U.S. treasury securities
|
|
152,205
|
|
|
18
|
|
|
(48
|
)
|
|
152,175
|
|
|
—
|
|
|
152,175
|
|
|
—
|
|
|||||||
Debt securities of U.S. government agencies and corporate entities
|
|
712,065
|
|
|
40
|
|
|
(1,335
|
)
|
|
710,770
|
|
|
—
|
|
|
552,968
|
|
|
157,802
|
|
|||||||
|
|
$
|
1,695,737
|
|
|
$
|
120
|
|
|
$
|
(1,440
|
)
|
|
$
|
1,694,417
|
|
|
$
|
658,364
|
|
|
$
|
863,063
|
|
|
$
|
172,990
|
|
|
|
June 30, 2019
|
||||||
|
|
Amortized
Cost
|
|
Estimated
Fair Value
|
||||
Due in one year or less
|
|
$
|
916,905
|
|
|
$
|
918,722
|
|
Due after one year through five years
|
|
362,960
|
|
|
365,032
|
|
||
Total
|
|
$
|
1,279,865
|
|
|
$
|
1,283,754
|
|
|
|
June 30,
|
|
December 31,
|
||||
|
|
2019
|
|
2018
|
||||
Prepaid expenses
|
|
$
|
9,138
|
|
|
$
|
10,401
|
|
Tenant incentives receivables
|
|
6,310
|
|
|
10,089
|
|
||
Interest receivable on marketable securities
|
|
7,044
|
|
|
7,909
|
|
||
Prepaid expenses and other current assets
|
|
$
|
22,492
|
|
|
$
|
28,399
|
|
|
|
June 30,
|
|
December 31,
|
||||
|
|
2019
|
|
2018
|
||||
Building
|
|
$
|
140,442
|
|
|
$
|
140,442
|
|
Laboratory equipment
|
|
102,006
|
|
|
96,907
|
|
||
Leasehold improvements
|
|
13,632
|
|
|
13,741
|
|
||
Furniture, fixtures and other
|
|
2,142
|
|
|
2,122
|
|
||
Computer equipment and software
|
|
11,665
|
|
|
11,513
|
|
||
Internally developed software
|
|
7,020
|
|
|
7,020
|
|
||
Construction in progress
|
|
10,829
|
|
|
4,688
|
|
||
|
|
287,736
|
|
|
276,433
|
|
||
Less: Accumulated depreciation
|
|
(79,227
|
)
|
|
(64,456
|
)
|
||
Property and equipment, net
|
|
$
|
208,509
|
|
|
$
|
211,977
|
|
|
|
June 30,
|
|
December 31,
|
||||
|
|
2019
|
|
2018
|
||||
In-licenses
|
|
$
|
—
|
|
|
$
|
22,000
|
|
Property and equipment
|
|
5,402
|
|
|
12,089
|
|
||
Compensation-related
|
|
16,001
|
|
|
23,406
|
|
||
External goods and services
|
|
23,186
|
|
|
21,578
|
|
||
Accrued liabilities
|
|
$
|
44,589
|
|
|
$
|
79,073
|
|
Fiscal Year
|
Minimum Lease Payments
|
|||
2019
|
(remainder of the year)
|
$
|
10,206
|
|
2020
|
|
22,481
|
|
|
2021
|
|
24,253
|
|
|
2022
|
|
23,697
|
|
|
2023
|
|
20,586
|
|
|
Thereafter
|
137,948
|
|
||
Total
|
$
|
239,171
|
|
|
|
Number of
Options
|
|
Weighted-
Average
Exercise
Price per
Share
|
|
Weighted-
Average
Grant
Date Fair
Value per
Share
|
|
Weighted-
Average
Remaining
Contractual
Term
|
|
Aggregate
Intrinsic
Value
(1)
(in thousands)
|
|||||||
Outstanding at December 31, 2018
|
|
50,821,132
|
|
|
$
|
12.16
|
|
|
$
|
6.59
|
|
|
7.1 years
|
|
$
|
220,434
|
|
Granted
|
|
6,280,966
|
|
|
20.24
|
|
|
11.87
|
|
|
|
|
|
||||
Exercised
|
|
(1,051,793
|
)
|
|
3.86
|
|
|
3.89
|
|
|
|
|
|
||||
Canceled/forfeited
|
|
(4,067,618
|
)
|
|
14.57
|
|
|
8.69
|
|
|
|
|
|
||||
Outstanding at June 30, 2019
|
|
51,982,687
|
|
|
13.14
|
|
|
7.05
|
|
|
7.2 years
|
|
181,371
|
|
|||
Exercisable at June 30, 2019
|
|
25,559,777
|
|
|
9.10
|
|
|
4.34
|
|
|
5.5 years
|
|
161,093
|
|
|||
Vested and expected to vest at June 30, 2019
|
|
26,422,410
|
|
|
17.04
|
|
|
9.68
|
|
|
8.9 years
|
|
20,278
|
|
|
Number of
Shares |
|
Weighted
Average
Fair Value
per Share
|
|||
Outstanding, non-vested at December 31, 2018
|
198,597
|
|
|
$
|
12.15
|
|
Issued
|
—
|
|
|
—
|
|
|
Vested
|
(107,475
|
)
|
|
12.15
|
|
|
Canceled, forfeited and adjustments, net
|
(314
|
)
|
|
12.15
|
|
|
Outstanding, non-vested at June 30, 2019
|
90,808
|
|
|
12.15
|
|
|
Units
|
|
Weighted-Average
Fair Value
per Unit
|
|||
Outstanding, non-vested at December 31, 2018
|
458,715
|
|
|
$
|
11.93
|
|
Issued
|
636,808
|
|
|
20.93
|
|
|
Vested
(1)
|
28,668
|
|
|
11.93
|
|
|
Canceled/forfeited
|
(21,629
|
)
|
|
20.93
|
|
|
Pending settlement
(1)
|
(28,668
|
)
|
|
11.93
|
|
|
Outstanding, non-vested at June 30, 2019
|
1,073,894
|
|
|
17.08
|
|
|
|
Weighted Average
|
||||||
|
|
Six Months Ended June 30,
|
||||||
|
|
2019
|
|
2018
|
||||
Options:
|
|
|
|
|
||||
Risk-free interest rate
|
|
2.42
|
%
|
|
2.71
|
%
|
||
Expected term
|
|
6.07 years
|
|
|
6.06 years
|
|
||
Expected volatility
|
|
62
|
%
|
|
64
|
%
|
||
Expected dividends
|
|
—
|
%
|
|
—
|
%
|
||
Weighted average fair value per share
|
|
$
|
11.87
|
|
|
$
|
8.63
|
|
|
|
|
|
|
||||
ESPP:
|
|
|
|
|
||||
Risk-free interest rate
|
|
2.31
|
%
|
|
|
|||
Expected term
|
|
0.50 years
|
|
|
|
|||
Expected volatility
|
|
50
|
%
|
|
|
|||
Expected dividends
|
|
—
|
%
|
|
|
|||
Weighted average fair value per share
|
|
19.85
|
|
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30,
|
||||||||||||
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Options
|
$
|
19,994
|
|
|
$
|
13,263
|
|
|
$
|
37,481
|
|
|
$
|
23,311
|
|
Restricted common stock and units
|
1,327
|
|
|
1,090
|
|
|
2,337
|
|
|
2,893
|
|
||||
ESPP
|
174
|
|
|
—
|
|
|
174
|
|
|
—
|
|
||||
Total
|
$
|
21,495
|
|
|
$
|
14,353
|
|
|
$
|
39,992
|
|
|
$
|
26,204
|
|
Research and development
|
$
|
12,869
|
|
|
$
|
8,428
|
|
|
$
|
23,652
|
|
|
$
|
15,784
|
|
General and administrative
|
8,626
|
|
|
5,925
|
|
|
16,340
|
|
|
10,420
|
|
||||
Total
|
$
|
21,495
|
|
|
$
|
14,353
|
|
|
$
|
39,992
|
|
|
$
|
26,204
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Numerator:
|
|
|
|
|
|
|
|
||||||||
Net loss
|
$
|
(135,054
|
)
|
|
$
|
(90,601
|
)
|
|
$
|
(267,711
|
)
|
|
$
|
(162,977
|
)
|
Cumulative dividends on redeemable convertible preferred stock
|
—
|
|
|
(3,481
|
)
|
|
—
|
|
|
(6,962
|
)
|
||||
Net loss attributable to common stockholders
|
$
|
(135,054
|
)
|
|
$
|
(94,082
|
)
|
|
$
|
(267,711
|
)
|
|
$
|
(169,939
|
)
|
Denominator:
|
|
|
|
|
|
|
|
||||||||
Weighted average common shares used in net loss per share attributable to common stockholders, basic and diluted
|
329,176,107
|
|
|
65,938,939
|
|
|
328,994,058
|
|
|
65,686,290
|
|
||||
Net loss per share attributable to common stockholders, basic and diluted
|
$
|
(0.41
|
)
|
|
$
|
(1.43
|
)
|
|
$
|
(0.81
|
)
|
|
$
|
(2.59
|
)
|
|
June 30,
|
||||
|
2019
|
|
2018
|
||
Redeemable convertible preferred stock
|
—
|
|
|
236,120,492
|
|
Stock options
|
51,982,687
|
|
|
44,269,380
|
|
Restricted common stock
|
90,808
|
|
|
410,607
|
|
Restricted common stock units
|
1,073,894
|
|
|
458,715
|
|
|
53,147,389
|
|
|
281,259,194
|
|
•
|
continue our platform research and drug discovery and development efforts;
|
•
|
conduct clinical studies for our investigational medicines;
|
•
|
manufacture clinical study materials and develop large-scale manufacturing capabilities;
|
•
|
seek regulatory approval for our investigational medicines;
|
•
|
maintain, expand, and protect our intellectual property;
|
•
|
hire additional personnel to support our program development effort to obtain regulatory approval and secure additional facilities for operations; and
|
•
|
operate as a public company.
|
•
|
Prophylactic vaccines
included eight development candidates across seven programs: RSV vaccine (mRNA-1777 and mRNA-1172 or V172), CMV vaccine (mRNA-1647), hMPV+PIV3 vaccine (mRNA-1653), H10N8 vaccine (mRNA-1440), H7N9 vaccine (mRNA-1851), Zika vaccine (mRNA-1893), and Chikungunya vaccine (mRNA-1388). We currently have seven programs for which the Phase 1 trial is either ongoing or has been completed.
|
•
|
Cancer vaccines
included two development candidates: Personalized cancer vaccine, or PCV, (mRNA-4157, NCI-4650) and KRAS vaccine (mRNA-5671 or V941). We are collaborating with Merck on both programs. PCV is in a Phase 1 clinical trial and the first patient has been consented in a Phase 2 clinical trial, and the KRAS vaccine is in a Phase 1 clinical trial.
|
•
|
Intratumoral immuno-oncology
included three development candidates: OX40L (mRNA-2416), OX40L+IL23+IL36γ (Triplet) (mRNA-2752), and IL12 (MEDI1191). OX40L is currently being evaluated in a Phase 1/2 trial that includes a Phase 2 expansion cohort in patients with advanced ovarian carcinoma. Triplet and IL12 are currently in Phase 1 clinical trials.
|
•
|
Localized regenerative therapeutics
included one development candidate, VEGF-A (AZD8601). The program is being led by AstraZeneca through clinical development and is in a Phase 2a clinical trial.
|
•
|
Systemic secreted therapeutics
included three development candidates: antibody against Chikungunya virus (mRNA-1944), Relaxin (AZD7970), and Fabry disease (mRNA-3630). The antibody against Chikungunya virus development candidate is in collaboration with DARPA and the program is in a Phase 1 clinical trial. The Relaxin program in collaboration with AstraZeneca and the Fabry disease program are both in preclinical development.
|
•
|
Systemic intracellular therapeutics
included four development candidates: MMA (mRNA-3704), PA (mRNA-3927), PKU (mRNA-3283), and GSD1a (mRNA-3745). The MMA program has open clinical sites for a Phase 1/2 clinical trial, and the PA, PKU, and GSD1a programs are in preclinical development.
|
•
|
RSV vaccine (mRNA-1777 and mRNA-1172 or V172):
The first subject has been dosed in the Phase 1 clinical trial of mRNA-1172 led by Merck. mRNA-1172 has shown enhanced potency in preclinical studies compared with the companies' first RSV candidate mRNA-1777.
|
•
|
CMV vaccine (mRNA-1647):
The Phase 1 clinical trial of mRNA-1647 has been fully enrolled, at a top dose of 300µg. This randomized, observer-blind and placebo-controlled clinical trial is designed to evaluate the safety and immunogenicity of mRNA-1647, a vaccine encoding the gB and pentamer complexes of CMV. CMV is a common human pathogen and a leading cause of birth defects.
|
•
|
Human metapneumovirus (hMPV) and parainfluenza type 3 (PIV3) vaccine (mRNA-1653):
Topline data from a second planned interim analysis of an ongoing Phase 1 randomized, observer-blind, placebo-controlled and dose-ranging clinical trial in healthy adults showed that hMPV and PIV3 serum neutralizing antibody titers remained above baseline through seven months. Topline data from the clinical trial’s first interim analysis, announced in February 2019, showed that mRNA-1653 boosted antibody titers one month after vaccination at all dose levels and was generally well-tolerated. We are planning to initiate a Phase 1b clinical trial of mRNA-1653 in seropositive toddler subjects.
|
•
|
Zika virus vaccine (mRNA-1893):
The first subject has been dosed in the Phase 1 clinical trial of mRNA-1893. This development candidate is being developed in collaboration with the U.S. Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.
|
•
|
Personalized cancer vaccines (PCVs) (mRNA-4157, NCI-4650):
We announced data from the Phase 1 clinical trial of PCV showing that it was well-tolerated at all dose levels studied, including up to 1 mg, elicited neoantigen-specific T-cell responses in one patient, and there were no dose-limiting toxicities or Grade 3/4 adverse events or serious adverse events reported when administered as a monotherapy or in combination with pembrolizumab. The most common Grade 2 adverse events were fatigue, soreness at the injection site, colitis, and myalgias. These safety, tolerability, and immunogenicity data and the initial clinical activity observed support our randomized Phase 2 clinical trial investigating Merck’s pembrolizumab (KEYTRUDA
®
) in combination with a 1 mg dose of mRNA-4157, compared to pembrolizumab alone, for the adjuvant treatment of high-risk resectable melanoma, and the first patient has been consented in this Phase 2 clinical trial. Part C of the Phase 1, open-label, multicenter clinical trial is enrolling and intended to evaluate mRNA-4157 in combination with Merck’s pembrolizumab in subjects with unresectable solid tumors. Additionally, the protocol for the Phase 1 clinical trial has been amended to include a cohort of 17 patients who are refractory to PD-1 inhibitors.
|
•
|
KRAS vaccine (mRNA-5671 or V941):
The first patient was dosed in the Phase 1 open-label, multi-center clinical trial to evaluate the safety and tolerability of mRNA-5671 both as a monotherapy and in combination with pembrolizumab. The clinical trial, led by Merck, will enroll patients with KRAS mutant advanced or metastatic non-small cell lung cancer, colorectal cancer, or pancreatic adenocarcinoma, and centrally confirmed Human Leukocyte Antigen (HLA) HLA-A*1101 and/or HLA-C*0802 allele expression. mRNA-5671 is designed to generate and present the four most prevalent KRAS mutations as neoantigens to the immune system.
|
•
|
OX40L (mRNA-2416):
Dosing is ongoing at the highest levels (8mg) in the Phase 1/2 open-label, multi-center, dose escalation and efficacy clinical trial evaluating intratumoral injections of mRNA-2416 in patients with advanced malignancies. A Phase 2 expansion cohort in patients with advanced ovarian carcinoma is preparing to start enrollment; this will include the combination of intratumoral mRNA-2416 with durvalumab (IMFINZI
®
).
|
•
|
OX40L + IL23 + IL36γ (Triplet) (mRNA-2752):
The first patient was dosed in the combination arm of the Phase 1 clinical trial of mRNA-2752. This clinical trial is evaluating mRNA-2752 as a single agent and in combination with durvalumab in patients with accessible solid tumors and lymphomas.
|
•
|
IL12 (MEDI1191):
The first patient was dosed with MEDI1191 monotherapy in the Phase 1 open-label, multi-center clinical trial evaluating intratumoral injections of MEDI1191 alone and in combination with a checkpoint inhibitor in patients with advanced solid tumors, being led by AstraZeneca. MEDI1191 is an mRNA encoding for IL12, a potent immunomodulatory cytokine.
|
•
|
Antibody against Chikungunya virus (mRNA-1944):
Six of eight subjects have been dosed in the third cohort (0.6 mg/kg) of the Phase 1 antibody against chikungunya virus (mRNA-1944) clinical trial. This clinical trial is evaluating the safety and tolerability of escalating doses of mRNA-1944 via intravenous infusion in healthy adults. mRNA-1944 is the first development candidate from our systemic secreted therapeutics modality to start clinical testing. The lipid nanoparticle (LNP) formulation used for mRNA-1944 is also utilized in Moderna’s MMA program.
|
•
|
Methylmalonic acidemia (MMA) (mRNA-3704)
:
Three clinical trial sites are open and actively recruiting patients for the Phase 1/2 open-label, dose escalation clinical trial evaluating mRNA-3704 for the treatment of MMA. The objectives of the clinical trial are to evaluate safety and tolerability, assess the pharmacodynamic response and characterize the pharmacokinetic profile of mRNA-3704. We recently updated the clinical trial protocol to widen the age bracket of the first cohort for this trial to allow for the enrollment of pediatric patients (now includes patients 8 years and older, a modification from adolescents aged 12-18.) This is our first rare disease program to advance into clinical testing.
|
•
|
MMA (mRNA-3704) and Propionic Acidemia (PA) (mRNA-3927) Natural History Study (MaP):
As of July 15, 2019, 71 patients have been enrolled in the study (35 MMA, 36 PA). This is a global, multi-center, non-interventional study for patients with confirmed diagnosis of MMA due to methylmalonyl-CoA mutase (MUT) deficiency or PA and is designed to identify and correlate clinical and biomarker endpoints for these disorders.
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Collaboration revenue:
|
|
|
|
|
|
|
|
||||||||
Merck
|
$
|
8,659
|
|
|
$
|
17,095
|
|
|
$
|
19,346
|
|
|
$
|
33,062
|
|
Vertex
|
1,183
|
|
|
2,390
|
|
|
3,797
|
|
|
6,533
|
|
||||
AstraZeneca
|
188
|
|
|
6,089
|
|
|
1,002
|
|
|
13,439
|
|
||||
Other
|
—
|
|
|
257
|
|
|
—
|
|
|
257
|
|
||||
Total collaboration revenue
|
$
|
10,030
|
|
|
$
|
25,831
|
|
|
$
|
24,145
|
|
|
$
|
53,291
|
|
•
|
cost to develop our platform;
|
•
|
discovery efforts leading to development candidates;
|
•
|
preclinical, nonclinical, and clinical development costs for our programs;
|
•
|
cost to develop our manufacturing technology and infrastructure; and
|
•
|
digital infrastructure costs.
|
•
|
personnel-related expenses, including salaries, benefits, and stock-based compensation expense;
|
•
|
expenses incurred under agreements with third parties, such as consultants, investigative sites, contract research organizations, or CROs, that conduct our preclinical and clinical studies, and in-licensing arrangements;
|
•
|
costs of acquiring, developing, and manufacturing materials for preclinical and clinical studies, including both internal manufacturing and third-party contract manufacturing organizations, or CMOs;
|
•
|
expenses incurred for the procurement of materials, laboratory supplies, and non-capital equipment used in the research and development process; and
|
•
|
facilities, depreciation, and amortization, and other direct and allocated expenses incurred as a result of research and development activities.
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Program expenses by modality:
|
|
|
|
|
|
|
|
||||||||
Prophylactic vaccines
|
$
|
12,398
|
|
|
$
|
8,901
|
|
|
$
|
32,660
|
|
|
$
|
14,492
|
|
Cancer vaccines
|
13,375
|
|
|
8,973
|
|
|
23,461
|
|
|
16,821
|
|
||||
Intratumoral immuno-oncology
|
2,775
|
|
|
5,075
|
|
|
7,193
|
|
|
10,564
|
|
||||
Localized regenerative therapeutics
|
8
|
|
|
5
|
|
|
16
|
|
|
80
|
|
||||
Systemic secreted therapeutics
|
4,484
|
|
|
3,714
|
|
|
9,117
|
|
|
9,063
|
|
||||
Systemic intracellular therapeutics
|
9,829
|
|
|
10,777
|
|
|
16,572
|
|
|
18,927
|
|
||||
Total program-specific expenses by modality
(1)
|
42,869
|
|
|
37,445
|
|
|
89,019
|
|
|
69,947
|
|
||||
Other research and development expenses:
|
|
|
|
|
|
|
|
||||||||
Discovery programs
|
15,635
|
|
|
6,532
|
|
|
28,550
|
|
|
15,678
|
|
||||
Platform research
|
24,256
|
|
|
21,042
|
|
|
48,753
|
|
|
42,177
|
|
||||
Technical development and unallocated manufacturing expenses
|
18,449
|
|
|
19,706
|
|
|
39,796
|
|
|
32,835
|
|
||||
Shared discovery and development expenses
|
14,355
|
|
|
12,320
|
|
|
29,238
|
|
|
19,176
|
|
||||
Stock-based compensation
|
12,932
|
|
|
7,434
|
|
|
23,715
|
|
|
14,790
|
|
||||
Total research and development expenses
|
$
|
128,496
|
|
|
$
|
104,479
|
|
|
$
|
259,071
|
|
|
$
|
194,603
|
|
|
|
|
|
|
|
|
|
(1)
|
Include a total of 21 development candidates for both
June 30, 2019
and
2018
. Program-specific expenses include external costs and allocated manufacturing costs of mRNA supply and consumables, and are reflected as of the beginning of the period in which the program was internally advanced to development or removed if development was ceased.
|
•
|
scope, progress, and expense of developing ongoing and future development candidates and investigational medicines;
|
•
|
entry in and completion of related preclinical studies;
|
•
|
enrollment in and completion of subsequent clinical trials;
|
•
|
safety and efficacy of investigational medicines resulting from these clinical trials;
|
•
|
changes in laws or regulations relevant to the investigational medicines in development;
|
•
|
receipt of the required regulatory approvals; and
|
•
|
commercialization, including establishing manufacturing and marketing capabilities.
|
|
Three Months Ended June 30,
|
|
Change 2019 vs. 2018
|
||||||||||
|
2019
|
|
2018
|
|
$
|
|
%
|
||||||
Revenue:
|
|
|
|
|
|
|
|
||||||
Collaboration revenue
|
$
|
10,030
|
|
|
$
|
25,831
|
|
|
$
|
(15,801
|
)
|
|
(61)%
|
Grant revenue
|
3,053
|
|
|
3,020
|
|
|
33
|
|
|
1%
|
|||
Total revenue
|
13,083
|
|
|
28,851
|
|
|
(15,768
|
)
|
|
(55)%
|
|||
Operating Expenses:
|
|
|
|
|
|
|
|
||||||
Research and development
|
128,496
|
|
|
104,479
|
|
|
24,017
|
|
|
23%
|
|||
General and administrative
|
28,523
|
|
|
21,387
|
|
|
7,136
|
|
|
33%
|
|||
Total operating expenses
|
157,019
|
|
|
125,866
|
|
|
31,153
|
|
|
25%
|
|||
Loss from operations
|
(143,936
|
)
|
|
(97,015
|
)
|
|
(46,921
|
)
|
|
48%
|
|||
Interest income
|
10,322
|
|
|
6,401
|
|
|
3,921
|
|
|
61%
|
|||
Other (expense) income, net
|
(1,764
|
)
|
|
171
|
|
|
(1,935
|
)
|
|
|
|||
Loss before income taxes
|
(135,378
|
)
|
|
(90,443
|
)
|
|
(44,935
|
)
|
|
50%
|
|||
(Benefit from) provision for income taxes
|
(324
|
)
|
|
158
|
|
|
(482
|
)
|
|
(305)%
|
|||
Net loss
|
$
|
(135,054
|
)
|
|
$
|
(90,601
|
)
|
|
$
|
(44,453
|
)
|
|
49%
|
|
Six Months Ended June 30,
|
|
Change 2019 vs. 2018
|
||||||||||
|
2019
|
|
2018
|
|
$
|
|
%
|
||||||
Revenue:
|
|
|
|
|
|
|
|
||||||
Collaboration revenue
|
$
|
24,145
|
|
|
$
|
53,291
|
|
|
$
|
(29,146
|
)
|
|
(55)%
|
Grant revenue
|
4,963
|
|
|
4,599
|
|
|
364
|
|
|
8%
|
|||
Total revenue
|
29,108
|
|
|
57,890
|
|
|
(28,782
|
)
|
|
(50)%
|
|||
Operating Expenses:
|
|
|
|
|
|
|
|
||||||
Research and development
|
259,071
|
|
|
194,603
|
|
|
64,468
|
|
|
33%
|
|||
General and administrative
|
55,806
|
|
|
37,704
|
|
|
18,102
|
|
|
48%
|
|||
Total operating expenses
|
314,877
|
|
|
232,307
|
|
|
82,570
|
|
|
36%
|
|||
Loss from operations
|
(285,769
|
)
|
|
(174,417
|
)
|
|
(111,352
|
)
|
|
64%
|
|||
Interest income
|
21,294
|
|
|
11,610
|
|
|
9,684
|
|
|
83%
|
|||
Other expense, net
|
(3,584
|
)
|
|
(12
|
)
|
|
(3,572
|
)
|
|
|
|||
Loss before income taxes
|
(268,059
|
)
|
|
(162,819
|
)
|
|
(105,240
|
)
|
|
65%
|
|||
(Benefit from) provision for income taxes
|
(348
|
)
|
|
158
|
|
|
(506
|
)
|
|
(320)%
|
|||
Net loss
|
$
|
(267,711
|
)
|
|
$
|
(162,977
|
)
|
|
$
|
(104,734
|
)
|
|
64%
|
|
Three Months Ended June 30,
|
|
Change 2019 vs. 2018
|
||||||||||
|
2019
|
|
2018
|
|
$
|
|
%
|
||||||
Gain on investment
|
17
|
|
|
533
|
|
|
(516
|
)
|
|
(97)%
|
|||
Interest expense
|
(1,541
|
)
|
|
(25
|
)
|
|
(1,516
|
)
|
|
6,064%
|
|||
Other expense, net
|
(240
|
)
|
|
(337
|
)
|
|
97
|
|
|
(29)%
|
|||
Total other (expense) income, net
|
$
|
(1,764
|
)
|
|
$
|
171
|
|
|
$
|
(1,935
|
)
|
|
|
|
Six Months Ended June 30,
|
|
Change 2019 vs. 2018
|
||||||||||
|
2019
|
|
2018
|
|
$
|
|
%
|
||||||
Gain on investment
|
14
|
|
|
591
|
|
|
(577
|
)
|
|
(98)%
|
|||
Interest expense
|
(3,074
|
)
|
|
(52
|
)
|
|
(3,022
|
)
|
|
5,812%
|
|||
Other expense, net
|
(524
|
)
|
|
(551
|
)
|
|
27
|
|
|
(5)%
|
|||
Total other expense, net
|
$
|
(3,584
|
)
|
|
$
|
(12
|
)
|
|
$
|
(3,572
|
)
|
|
|
|
Six Months Ended June 30,
|
||||||
|
2019
|
|
2018
|
||||
Net cash (used in) provided by:
|
|
|
|
||||
Operating activities
|
$
|
(256,147
|
)
|
|
$
|
(159,634
|
)
|
Investing activities
|
(258,660
|
)
|
|
(495,349
|
)
|
||
Financing activities
|
7,764
|
|
|
660,357
|
|
||
Net (decrease) increase in cash, cash equivalents and restricted cash
|
$
|
(507,043
|
)
|
|
$
|
5,374
|
|
Exhibit No.
|
|
Exhibit Index
|
|
|
|
10.1†
|
|
|
31.1
|
|
|
31.2
|
|
|
32.1+
|
|
|
101.INS
|
|
XBRL Instance Document
|
101.SCH
|
|
XBRL Taxonomy Extension Schema Document
|
101.CAL
|
|
XBRL Taxonomy Extension Calculation Document
|
101.DEF
|
|
XBRL Taxonomy Extension Definition Linkbase Document
|
101.LAB
|
|
XBRL Taxonomy Extension Labels Linkbase Document
|
101.PRE
|
|
XBRL Taxonomy Extension Presentation Link Document
|
|
|
|
|
+
|
The certification furnished in Exhibit 32.1 hereto is deemed to accompany this Form 10-Q and will not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended. Such certification will not be deemed to be incorporated by reference into any filings under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except to the extent that the Registrant specifically incorporates it by reference.
|
†
|
Portions of this exhibit (indicated by asterisks) have been omitted in accordance with the rules of the Securities and Exchange Commission.
|
|
|
|
|
|
|
|
MODERNA, INC.
|
|
|
|
|
Date:
|
|
By:
|
/s/ Stéphane Bancel
|
August 8, 2019
|
|
|
|
|
|
|
Stéphane Bancel
|
|
|
|
Chief Executive Officer and Director
|
|
|
|
(
Principal Executive Officer)
|
|
|
|
|
Date:
|
|
By:
|
/s/ Lorence Kim, M.D.
|
August 8, 2019
|
|
|
|
|
|
|
Lorence Kim, M.D.
|
|
|
|
Chief Financial Officer
|
|
|
|
(
Principal Financial Officer)
|
|
|
|
|
1 Year Moderna Chart |
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