|
|
|
|
|
|
|
•
|
delays or difficulties in enrolling patients in our clinical trials, including travel restrictions on patients and constraints on the capacity of our clinical trial sites;
|
•
|
delays or difficulties in clinical site initiation, including difficulties in training clinical site investigators and clinical site staff;
|
•
|
delays or disruptions in non-clinical experiments and investigational new drug application-enabling good laboratory practice standard toxicology studies due to unforeseen circumstances in supply chain;
|
•
|
delays or disruptions in our ability to manufacture programmed T cell therapies due to supply chain and transportation system disruptions or lack of manufacturing staff;
|
•
|
increased rates of patients withdrawing from our clinical trials following enrollment as a result of contracting COVID-19, being forced to quarantine, or being unable to visit clinical trial locations;
|
•
|
diversion or prioritization of healthcare resources away from the conduct of clinical trials and towards the COVID-19 pandemic, including the diversion of hospitals serving as our clinical trial sites and hospital staff supporting the conduct of our clinical trials, particularly for clinical trials that require in-patient monitoring following administration of the product candidate;
|
•
|
delays or disruptions in the availability of clinical site staff, who, as healthcare providers, may have heightened exposure to COVID-19, which, in turn, could adversely impact our clinical trial operations;
|
•
|
interruption of our key clinical trial activities, such as clinical assessments at pre-specified timepoints during the trial and clinical trial site data monitoring, due to limitations on travel imposed or recommended by governmental entities, employers and others or interruption of clinical trial subject visits and study procedures (particularly any procedures that may be deemed non-essential), which may impact the integrity of subject data and clinical study endpoints;
|
•
|
interruption or delays in the operations of the U.S. Food and Drug Administration, European Medicines Agency and comparable foreign regulatory agencies or their refusal to accept data from clinical trials in affected geographies, which may impact approval timelines;
|
•
|
delays in necessary interactions with local regulators, ethics committees and other important agencies and contractors due to limitations in employee resources or forced furlough of government employees;
|
•
|
limitations on employee resources that would otherwise be focused on the conduct of our preclinical studies and clinical trials, including because of sickness of employees or their families, the desire of employees to avoid contact with large groups of people, an increased reliance on working from home or mass transit disruptions; and
|
•
|
reduced ability to engage with the medical and investor communities due to the cancellation of conferences scheduled throughout the year.
|
Exhibit
No.
|
|
Description
|
|
|
|
|
Unaudited Condensed Consolidated Interim Financial Statements for the Three Months Ended March 31, 2020
|
|
|
|
|
|
Management’s Discussion and Analysis of Financial Condition and Results of Operations for the Three Months Ended March 31, 2020
|
|
|
|
|
101
|
|
The following materials from this Report on Form 6-K are formatted in XBRL (eXtensible Business Reporting Language): (i) Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three Months ended March 31, 2020 and 2019 (Unaudited), (ii) Condensed Consolidated Balance Sheet as at March 31, 2020 and December 31, 2019 (Unaudited), (iii) Condensed Consolidated Statements of Changes in Shareholders’ Equity for the Three ended March 31, 2020 and 2019 (Unaudited), (iv) Condensed Consolidated Statements of Cash Flows for the Three Months ended March 31, 2020 and 2019 (Unaudited), and (v) Notes to Condensed Consolidated Financial Statements (Unaudited).
|
|
|
Autolus Therapeutics plc
|
||
|
|
|
|
|
Date:
|
May 7, 2020
|
By:
|
/s/ Christian Itin
|
|
|
|
|
Name
|
Christian Itin, Ph.D.
|
|
|
|
Title:
|
Chief Executive Officer
|
|
|
|
|
||||
|
March 31,
2020 |
|
December 31,
2019 |
||||
Assets
|
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash
|
$
|
243,312
|
|
|
$
|
210,643
|
|
Restricted cash
|
786
|
|
|
787
|
|
||
Prepaid expenses and other assets, current
|
36,844
|
|
|
37,826
|
|
||
Total current assets
|
280,942
|
|
|
249,256
|
|
||
Non-current assets:
|
|
|
|
||||
Property and equipment, net
|
29,800
|
|
|
28,164
|
|
||
Right of use assets, net
|
23,713
|
|
|
23,409
|
|
||
Long-term deposits
|
1,933
|
|
|
2,040
|
|
||
Prepaid expenses and other assets, non-current
|
652
|
|
|
—
|
|
||
Deferred tax asset
|
410
|
|
|
410
|
|
||
Intangible assets, net
|
214
|
|
|
254
|
|
||
Total assets
|
$
|
337,664
|
|
|
$
|
303,533
|
|
Liabilities and shareholders' equity
|
|
|
|
||||
Current liabilities:
|
|
|
|
||||
Accounts payable
|
1,057
|
|
|
1,075
|
|
||
Accrued expenses and other liabilities
|
22,471
|
|
|
21,398
|
|
||
Lease liabilities
|
2,523
|
|
|
2,511
|
|
||
Total current liabilities
|
26,051
|
|
|
24,984
|
|
||
Non-current liabilities:
|
|
|
|
||||
Lease liabilities
|
24,135
|
|
|
23,710
|
|
||
Total liabilities
|
50,186
|
|
|
48,694
|
|
||
|
|
|
|
||||
Shareholders' equity:
|
|
|
|
||||
Ordinary shares, $0.000042 par value; 200,000,000 shares authorized as of March 31, 2020 and December 31, 2019; 52,247,932 and 44,983,006, shares issued and outstanding at March 31, 2020 and December 31, 2019, respectively
|
3
|
|
|
2
|
|
||
Deferred shares, £0.00001 par value; 34,425 shares authorized, issued and outstanding at March 31, 2020 and December 31, 2019
|
—
|
|
|
—
|
|
||
Deferred B shares, £0.00099 par value; 88,893,548 shares authorized, issued and outstanding at March 31, 2020 and December 31, 2019
|
118
|
|
|
118
|
|
||
Deferred C shares, £0.000008 par value; 1 share authorized, issued and outstanding at March 31, 2020 and December 31, 2019
|
—
|
|
|
—
|
|
||
Additional paid-in capital
|
580,772
|
|
|
500,560
|
|
||
Accumulated other comprehensive loss
|
(26,392
|
)
|
|
(8,691
|
)
|
||
Accumulated deficit
|
(267,023
|
)
|
|
(237,150
|
)
|
||
Total shareholders' equity
|
287,478
|
|
|
254,839
|
|
||
Total liabilities and shareholders' equity
|
$
|
337,664
|
|
|
$
|
303,533
|
|
|
Three Months Ended March 31,
|
||||||
|
2020
|
|
2019
|
||||
Grant income
|
$
|
338
|
|
|
$
|
1,964
|
|
Operating expenses:
|
|
|
|
||||
Research and development
|
(31,287
|
)
|
|
(22,565
|
)
|
||
General and administrative
|
(7,614
|
)
|
|
(9,556
|
)
|
||
Total operating expenses, net
|
(38,563
|
)
|
|
(30,157
|
)
|
||
Other income (expense):
|
|
|
|
||||
Interest income
|
510
|
|
|
541
|
|
||
Other income (expense)
|
4,484
|
|
|
(984
|
)
|
||
Total other income, net
|
4,994
|
|
|
(443
|
)
|
||
Net loss before income tax
|
(33,569
|
)
|
|
(30,600
|
)
|
||
Income tax benefit
|
3,696
|
|
|
3,421
|
|
||
Net loss attributable to ordinary shareholders
|
(29,873
|
)
|
|
(27,179
|
)
|
||
Other comprehensive loss:
|
|
|
|
||||
Foreign currency exchange translation adjustment
|
(17,701
|
)
|
|
5,051
|
|
||
Total comprehensive loss
|
$
|
(47,574
|
)
|
|
$
|
(22,128
|
)
|
|
|
|
|
||||
Basic and diluted net loss per ordinary share
|
$
|
(0.60
|
)
|
|
$
|
(0.69
|
)
|
Weighted-average basic and diluted ordinary shares
|
49,859,739
|
|
|
39,471,029
|
|
Three Months Ended March 31, 2019
|
|||||||||||||||||||||||||||||||||||||||||||
|
Ordinary Shares
|
|
Deferred Shares
|
|
Deferred B Shares
|
|
Deferred C Shares
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
Additional Paid in Capital
|
|
Accumulated other comprehensive gain/(loss)
|
|
Accumulated deficit
|
|
Total
|
||||||||||||||||||||
Balance at December 31, 2018
|
40,145,617
|
|
|
$
|
2
|
|
|
34,425
|
|
|
$
|
—
|
|
|
88,893,548
|
|
|
$
|
118
|
|
|
1
|
|
|
$
|
—
|
|
|
$
|
361,311
|
|
|
$
|
(15,488
|
)
|
|
$
|
(113,301
|
)
|
|
$
|
232,642
|
|
Share-based compensation expense
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
7,365
|
|
|
—
|
|
|
—
|
|
|
7,365
|
|
||||||||
Restricted shares - forfeited
|
(302)
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||||
Exercise of stock options
|
2,126
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
4
|
|
|
—
|
|
|
—
|
|
|
4
|
|
||||||||
Unrealized gain on foreign currency translation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
5,051
|
|
|
—
|
|
|
5,051
|
|
||||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(27,179
|
)
|
|
(27,179
|
)
|
||||||||
Balance at March 31, 2019
|
40,147,441
|
|
|
$
|
2
|
|
|
34,425
|
|
|
$
|
—
|
|
|
88,893,548
|
|
|
$
|
118
|
|
|
1
|
|
|
$
|
—
|
|
|
$
|
368,680
|
|
|
$
|
(10,437
|
)
|
|
$
|
(140,480
|
)
|
|
$
|
217,883
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||
Three Months Ended March 31, 2020
|
|||||||||||||||||||||||||||||||||||||||||||
|
Ordinary Shares
|
|
Deferred Shares
|
|
Deferred B Shares
|
|
Deferred C Shares
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
Additional Paid in Capital
|
|
Accumulated other comprehensive gain/(loss)
|
|
Accumulated deficit
|
|
Total
|
||||||||||||||||||||
Balance at December 31, 2019
|
44,983,006
|
|
|
2
|
|
|
34,425
|
|
|
$
|
—
|
|
|
88,893,548
|
|
|
$
|
118
|
|
|
1
|
|
|
$
|
—
|
|
|
$
|
500,560
|
|
|
$
|
(8,691
|
)
|
|
$
|
(237,150
|
)
|
|
$
|
254,839
|
|
|
Issuance of ordinary shares, net of issuance costs
|
7,250,000
|
|
|
1
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
73,952
|
|
|
—
|
|
|
—
|
|
|
73,953
|
|
||||||||
Share-based compensation expense
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
6,235
|
|
|
—
|
|
|
—
|
|
|
6,235
|
|
||||||||
Restricted shares - forfeited
|
(50)
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||||
Exercise of stock options
|
14,976
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
24
|
|
|
—
|
|
|
—
|
|
|
24
|
|
||||||||
Unrealized loss on foreign currency translation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(17,701
|
)
|
|
—
|
|
|
(17,701
|
)
|
||||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(29,873
|
)
|
|
(29,873
|
)
|
||||||||
Balance at March 31, 2020
|
52,247,932
|
|
|
$
|
3
|
|
|
34,425
|
|
|
$
|
—
|
|
|
88,893,548
|
|
|
$
|
118
|
|
|
1
|
|
|
$
|
—
|
|
|
$
|
580,772
|
|
|
$
|
(26,392
|
)
|
|
$
|
(267,023
|
)
|
|
$
|
287,478
|
|
|
Three Months Ended March 31,
|
||||||
|
2020
|
|
2019
|
||||
Cash flows from operating activities:
|
|
|
|
||||
Net loss
|
$
|
(29,873
|
)
|
|
$
|
(27,179
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
||||
Depreciation and amortization
|
1,261
|
|
|
1,639
|
|
||
Share-based compensation (net of amount capitalized)
|
6,189
|
|
|
7,365
|
|
||
Gain on termination of operating lease
|
(160
|
)
|
|
—
|
|
||
Loss on disposal of property and equipment
|
—
|
|
|
43
|
|
||
Changes in operating assets and liabilities
|
|
|
|
||||
Prepaid expenses and other current assets
|
(1,186
|
)
|
|
(6,816
|
)
|
||
Prepaid expenses and other non-current assets
|
(233
|
)
|
|
—
|
|
||
Long-term deposits
|
(18
|
)
|
|
(707
|
)
|
||
Right of use assets, net
|
769
|
|
|
—
|
|
||
Accounts payable
|
(124
|
)
|
|
(493
|
)
|
||
Accrued expenses and other liabilities
|
(361
|
)
|
|
(370
|
)
|
||
Lease liabilities
|
(297
|
)
|
|
—
|
|
||
Net cash used in operating activities
|
(24,033
|
)
|
|
(26,518
|
)
|
||
Cash flows from investing activities:
|
|
|
|
||||
Purchases of property and equipment
|
(2,637
|
)
|
|
(7,329
|
)
|
||
Net cash used in investing activities
|
(2,637
|
)
|
|
(7,329
|
)
|
||
Cash flows from financing activities:
|
|
|
|
||||
Proceeds of issuance of ordinary shares, net of issuance costs
|
74,310
|
|
|
4
|
|
||
Net cash provided by financing activities
|
74,310
|
|
|
4
|
|
||
Effect of exchange rate changes on cash and restricted cash
|
(14,972
|
)
|
|
4,702
|
|
||
Net increase (decrease) in cash and restricted cash
|
32,668
|
|
|
(29,141
|
)
|
||
Cash and restricted cash, beginning of period
|
211,430
|
|
|
217,555
|
|
||
Cash and restricted cash, end of period
|
$
|
244,098
|
|
|
$
|
188,414
|
|
|
|
|
|
||||
Supplemental non-cash flow information
|
|
|
|
||||
Property and equipment purchases included in accounts payable and accrued expenses
|
$
|
4,624
|
|
|
$
|
1,226
|
|
Right of use assets terminated and obtained in exchange for operating lease liabilities, net
|
$
|
2,487
|
|
|
$
|
—
|
|
Capitalized implementation costs included in accrued expenses
|
$
|
607
|
|
|
$
|
—
|
|
Issuance costs included in accrued expenses
|
$
|
334
|
|
|
$
|
—
|
|
Capitalized share-based compensation
|
$
|
46
|
|
|
$
|
—
|
|
|
|
|
|
||||
Reconciliation of cash and restricted cash reported within the condensed consolidated balance sheets:
|
|
|
|
||||
Cash
|
$
|
243,312
|
|
|
$
|
187,733
|
|
Restricted cash
|
786
|
|
|
681
|
|
||
Total cash and restricted cash
|
$
|
244,098
|
|
|
$
|
188,414
|
|
|
As of March 31,
|
||
|
2020
|
|
2019
|
Unvested restricted incentive shares and units
|
722,028
|
|
605,744
|
Share options
|
5,914,949
|
|
3,997,663
|
Total
|
6,636,977
|
|
4,603,407
|
|
March 31,
2020 |
|
December 31,
2019 |
||||
Research and development claims receivable
|
$
|
29,753
|
|
|
$
|
27,567
|
|
Prepayments
|
5,181
|
|
|
7,023
|
|
||
VAT receivable
|
872
|
|
|
1,928
|
|
||
Grant income receivable
|
330
|
|
|
547
|
|
||
Other assets
|
334
|
|
|
279
|
|
||
Other receivable
|
374
|
|
|
482
|
|
||
Total prepaid expenses and other current assets
|
$
|
36,844
|
|
|
$
|
37,826
|
|
|
March 31,
2020 |
|
December 31,
2019 |
||||
Lab equipment
|
$
|
18,824
|
|
|
$
|
18,214
|
|
Office equipment
|
2,138
|
|
|
2,211
|
|
||
Furniture and fixtures
|
1,222
|
|
|
1,301
|
|
||
Leasehold improvements
|
9,684
|
|
|
10,316
|
|
||
Assets under construction
|
7,154
|
|
|
4,687
|
|
||
Less: accumulated depreciation
|
(9,222
|
)
|
|
(8,565
|
)
|
||
Total property and equipment, net
|
$
|
29,800
|
|
|
$
|
28,164
|
|
|
March 31,
2020 |
|
December 31,
2019 |
||||
Compensation and benefits
|
$
|
3,408
|
|
|
$
|
6,568
|
|
Research and development costs
|
14,173
|
|
|
10,449
|
|
||
UCLB milestone and option
|
810
|
|
|
663
|
|
||
Professional fees
|
3,125
|
|
|
2,611
|
|
||
U.S. Corporate and local tax
|
—
|
|
|
391
|
|
||
Other liabilities
|
955
|
|
|
716
|
|
||
Total accrued expenses and other liabilities
|
$
|
22,471
|
|
|
$
|
21,398
|
|
|
March 31,
|
|
2020
|
Expected option life (years)
|
6.08
|
Risk-free interest rate
|
0.58% - 1.66%
|
Expected volatility
|
76.38% - 77.64%
|
Expected dividend yield
|
—%
|
|
Number of
Options |
|
Weighted-Average Exercise Price
|
|
Weighted-Average Remaining Contractual Term (Years)
|
|
Aggregate Intrinsic Value
|
||||||
Outstanding as of December 31, 2019
|
5,936,239
|
|
|
$
|
17.71
|
|
|
9.02
|
|
|
$
|
11,873
|
|
Granted
|
96,500
|
|
|
$
|
8.81
|
|
|
—
|
|
|
—
|
|
|
Exercised
|
(14,976
|
)
|
|
$
|
1.77
|
|
|
—
|
|
|
—
|
|
|
Canceled or forfeited
|
(102,814
|
)
|
|
$
|
24.62
|
|
|
—
|
|
|
—
|
|
|
Outstanding as of March 31, 2020
|
5,914,949
|
|
|
$
|
17.49
|
|
|
8.79
|
|
|
$
|
2,885
|
|
Exercisable as of March 31, 2020
|
1,735,080
|
|
|
$
|
17.48
|
|
|
8.17
|
|
|
$
|
2,013
|
|
Vested and expected to vest as of March 31, 2020
|
5,914,949
|
|
|
$
|
17.49
|
|
|
8.79
|
|
|
$
|
2,885
|
|
|
Number of
restricted shares |
|
Weighted average grant date fair value
|
|||
Unvested and outstanding at December 31, 2019
|
314,744
|
|
|
$
|
4.22
|
|
Granted
|
—
|
|
|
—
|
|
|
Vested
|
(91,416
|
)
|
|
4.32
|
|
|
Canceled or forfeited
|
(50
|
)
|
|
4.44
|
|
|
Unvested and outstanding at March 31, 2020
|
223,278
|
|
|
$
|
4.18
|
|
|
Number of
restricted shares |
|
Weighted average grant date fair value
|
|||
Unvested and outstanding at December 31, 2019
|
500,000
|
|
|
$
|
12.09
|
|
Granted
|
—
|
|
|
—
|
|
|
Vested
|
—
|
|
|
—
|
|
|
Canceled or forfeited
|
(1,250
|
)
|
|
12.09
|
|
|
Unvested and outstanding at March 31, 2020
|
498,750
|
|
|
$
|
12.09
|
|
|
Three Months Ended March 31,
|
||||||
|
2020
|
|
2019
|
||||
Research and development
|
$
|
4,562
|
|
|
$
|
4,144
|
|
General and administrative
|
1,627
|
|
|
3,221
|
|
||
Capitalized to property and equipment
|
46
|
|
|
—
|
|
||
Total share-based compensation expense
|
$
|
6,235
|
|
|
$
|
7,365
|
|
•
|
expenses incurred under agreements with contract research organizations, or CROs, as well as investigative sites and consultants that conduct our clinical trials, preclinical studies and other scientific development services;
|
•
|
manufacturing scale-up expenses and the cost of acquiring and manufacturing preclinical and clinical trial materials;
|
•
|
employee-related expenses, including salaries, related benefits, travel and share-based compensation expense for employees engaged in research and development functions;
|
•
|
expenses incurred for outsourced professional scientific development services;
|
•
|
costs for laboratory materials and supplies used to support our research activities;
|
•
|
allocated facilities costs, depreciation and other expenses, which include rent and utilities; and
|
•
|
upfront, milestone and management fees for maintaining licenses under our third-party licensing agreements.
|
|
Three Months Ended
March 31, |
|
2020-2019
|
||||||||
|
2020
|
|
2019
|
|
Change
|
||||||
|
(in thousands)
|
||||||||||
Direct research and development expenses by program:
|
|
|
|
|
|
||||||
B cell malignancies (AUTO1 & AUTO3)
|
$
|
3,784
|
|
|
$
|
1,912
|
|
|
$
|
1,872
|
|
T cell lymphoma (AUTO4 & AUTO 5)
|
171
|
|
|
333
|
|
|
(162
|
)
|
|||
Multiple myeloma (AUTO8 / AUTO2)
|
52
|
|
|
323
|
|
|
(271
|
)
|
|||
Solid tumors (AUTO6 & AUTO7)
|
88
|
|
|
287
|
|
|
(199
|
)
|
|||
Total direct research and development expense
|
4,095
|
|
|
2,855
|
|
|
1,240
|
|
|||
Research and discovery expense and unallocated costs:
|
|
|
|
|
|
|
|
|
|||
Personnel related (including share-based compensation)
|
15,263
|
|
|
12,637
|
|
|
2,626
|
|
|||
Indirect research and development expense
|
11,929
|
|
|
7,073
|
|
|
4,856
|
|
|||
Total research and development expenses
|
$
|
31,287
|
|
|
$
|
22,565
|
|
|
$
|
8,722
|
|
•
|
the scope, progress, outcome and costs of our clinical trials and other research and development activities, including establishing an appropriate safety profile with IND-directed studies;
|
•
|
successful patient enrollment in, and the initiation and completion of, clinical trials;
|
•
|
the timing, receipt and terms of any marketing approvals from applicable regulatory authorities;
|
•
|
establishing commercial manufacturing capabilities or making arrangements with third-party manufacturers;
|
•
|
development and timely delivery of commercial-grade drug formulations that can be used in our clinical trials and for commercial manufacturing;
|
•
|
obtaining, maintaining, defending and enforcing patent claims and other intellectual property rights;
|
•
|
significant and changing government regulation;
|
•
|
launching commercial sales of our product candidates, if and when approved, whether alone or in collaboration with others;
|
•
|
maintaining a continued acceptable safety profile of the product candidates following approval; and
|
•
|
significant competition and rapidly changing technologies within the biopharmaceutical industry.
|
|
Three Months Ended
March 31, |
|
|
||||||||
|
2020
|
|
2019
|
|
Change
|
||||||
Grant income
|
$
|
338
|
|
|
$
|
1,964
|
|
|
$
|
(1,626
|
)
|
Operating expenses:
|
|
|
|
|
|
||||||
Research and development
|
(31,287
|
)
|
|
(22,565
|
)
|
|
(8,722
|
)
|
|||
General and administrative
|
(7,614
|
)
|
|
(9,556
|
)
|
|
1,942
|
|
|||
Total operating expenses, net
|
(38,563
|
)
|
|
(30,157
|
)
|
|
(8,406
|
)
|
|||
Other income (expense):
|
|
|
|
|
|
||||||
Interest income
|
510
|
|
|
541
|
|
|
(31
|
)
|
|||
Other income (expense)
|
4,484
|
|
|
(984
|
)
|
|
5,468
|
|
|||
Total other income, net
|
4,994
|
|
|
(443
|
)
|
|
5,437
|
|
|||
Net loss before income tax
|
(33,569
|
)
|
|
(30,600
|
)
|
|
(2,969
|
)
|
|||
Income tax benefit
|
3,696
|
|
|
3,421
|
|
|
275
|
|
|||
Net loss attributable to ordinary shareholders
|
$
|
(29,873
|
)
|
|
$
|
(27,179
|
)
|
|
$
|
(2,694
|
)
|
|
Three Months Ended
March 31, |
||||||
|
2020
|
|
2019
|
||||
|
(in thousands)
|
||||||
Net cash used in operating activities
|
$
|
(24,033
|
)
|
|
$
|
(26,518
|
)
|
Net cash used in investing activities
|
(2,637
|
)
|
|
(7,329
|
)
|
||
Net cash provided by financing activities
|
74,310
|
|
|
4
|
|
||
Effect of exchange rate changes on cash and restricted cash
|
(14,972
|
)
|
|
4,702
|
|
||
Net increase in cash and restricted cash
|
$
|
32,668
|
|
|
$
|
(29,141
|
)
|
•
|
seek regulatory approvals for any product candidates that successfully complete preclinical and clinical trials;
|
•
|
establish a sales, marketing and distribution infrastructure in anticipation of commercializing of any product candidates for which we may obtain marketing approval and intend to commercialize on our own or jointly;
|
•
|
hire additional clinical, medical and development personnel;
|
•
|
expand our infrastructure and facilities to accommodate our growing employee base; and
|
•
|
maintain, expand and protect our intellectual property portfolio.
|
•
|
the scope, progress, outcome and costs of our clinical trials and other research and development activities;
|
•
|
the costs, timing, receipt and terms of any marketing approvals from applicable regulatory authorities;
|
•
|
the costs of future activities, including product sales, medical affairs, marketing, manufacturing and distribution, for any of our product candidates for which we receive marketing approval;
|
•
|
the revenue, if any, received from commercial sale of our products, should any of our product candidates receive marketing approval;
|
•
|
the costs and timing of hiring new employees to support our continued growth;
|
•
|
the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims; and
|
•
|
the extent to which we in-license or acquire additional product candidates or technologies.
|