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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Flex Pharma, Inc. | NASDAQ:FLKS | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 0.6068 | 0.5751 | 0.6053 | 0 | 01:00:00 |
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(Mark One)
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ý
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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For the quarterly period ended June 30, 2018
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OR
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|
o
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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For the Transition Period from to
|
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Delaware
(State or Other Jurisdiction of
Incorporation or Organization)
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46-5087339
(I.R.S. Employer
Identification Number)
|
|
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Large Accelerated Filer
o
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Accelerated Filer
o
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Non-accelerated Filer
o
|
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Smaller Reporting Company
ý
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Emerging Growth Company
ý
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(Do not check if
a smaller reporting company)
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Page
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Item 1.
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Financial Statements
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|
June 30,
2018 |
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December 31,
2017 |
||||
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|
||||
Assets
|
|
|
|
|
|
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Current assets:
|
|
|
|
|
|
||
Cash and cash equivalents
|
$
|
15,756,971
|
|
|
$
|
19,186,036
|
|
Marketable securities
|
—
|
|
|
14,129,723
|
|
||
Accounts receivable
|
17,329
|
|
|
10,385
|
|
||
Inventory
|
275,693
|
|
|
431,891
|
|
||
Prepaid expenses and other current assets
|
856,118
|
|
|
777,102
|
|
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Total current assets
|
16,906,111
|
|
|
34,535,137
|
|
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Property and equipment, net
|
180,044
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|
|
331,040
|
|
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Restricted cash
|
126,595
|
|
|
126,595
|
|
||
Total assets
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$
|
17,212,750
|
|
|
$
|
34,992,772
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Liabilities and stockholders' equity
|
|
|
|
|
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Current liabilities:
|
|
|
|
|
|
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Accounts payable
|
$
|
1,145,333
|
|
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$
|
2,004,440
|
|
Accrued expenses and other current liabilities
|
2,588,596
|
|
|
3,712,221
|
|
||
Deferred revenue
|
—
|
|
|
72,188
|
|
||
Deferred rent, current portion
|
58,821
|
|
|
58,821
|
|
||
Total current liabilities
|
3,792,750
|
|
|
5,847,670
|
|
||
Deferred rent, net of current portion
|
9,804
|
|
|
39,214
|
|
||
Total liabilities
|
3,802,554
|
|
|
5,886,884
|
|
||
Stockholders' equity:
|
|
|
|
|
|
||
Preferred stock, $0.0001 par value; 10,000,000 shares authorized at June 30, 2018 and December 31, 2017; none issued or outstanding at June 30, 2018 and December 31, 2017
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—
|
|
|
—
|
|
||
Common stock, $0.0001 par value; 100,000,000 shares authorized at June 30, 2018 and December 31, 2017; 18,069,476 and 17,972,166 shares issued at June 30, 2018 and December 31, 2017, and 18,066,142 and 17,797,178 shares outstanding at June 30, 2018 and December 31, 2017, respectively
|
1,807
|
|
|
1,780
|
|
||
Additional paid-in capital
|
141,722,546
|
|
|
140,184,630
|
|
||
Accumulated other comprehensive loss
|
—
|
|
|
(1,247
|
)
|
||
Accumulated deficit
|
(128,314,157
|
)
|
|
(111,079,275
|
)
|
||
Total stockholders' equity
|
13,410,196
|
|
|
29,105,888
|
|
||
Total liabilities and stockholders' equity
|
$
|
17,212,750
|
|
|
$
|
34,992,772
|
|
|
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Three Months Ended June 30, 2018
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|
Three Months Ended June 30, 2017
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Six Months Ended June 30, 2018
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|
Six Months Ended June 30, 2017
|
||||||||
Net product revenue
|
$
|
241,416
|
|
|
$
|
330,688
|
|
|
$
|
417,671
|
|
|
$
|
570,980
|
|
Other revenue
|
4,086
|
|
|
4,835
|
|
|
6,413
|
|
|
7,090
|
|
||||
Total revenue
|
245,502
|
|
|
335,523
|
|
|
424,084
|
|
|
578,070
|
|
||||
Costs and expenses:
|
|
|
|
|
|
|
|
|
|
||||||
Cost of product revenue
|
179,945
|
|
|
145,325
|
|
|
263,879
|
|
|
224,431
|
|
||||
Research and development
|
6,174,589
|
|
|
4,076,220
|
|
|
10,854,770
|
|
|
7,991,194
|
|
||||
Selling, general and administrative
|
2,994,649
|
|
|
4,990,943
|
|
|
6,691,936
|
|
|
9,585,659
|
|
||||
Total costs and expenses
|
9,349,183
|
|
|
9,212,488
|
|
|
17,810,585
|
|
|
17,801,284
|
|
||||
Loss from operations
|
(9,103,681
|
)
|
|
(8,876,965
|
)
|
|
(17,386,501
|
)
|
|
(17,223,214
|
)
|
||||
Interest income, net
|
51,809
|
|
|
72,342
|
|
|
111,402
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|
|
150,196
|
|
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Net loss
|
$
|
(9,051,872
|
)
|
|
$
|
(8,804,623
|
)
|
|
$
|
(17,275,099
|
)
|
|
$
|
(17,073,018
|
)
|
Net loss attributable to common stockholders
|
$
|
(9,051,872
|
)
|
|
$
|
(8,804,623
|
)
|
|
$
|
(17,275,099
|
)
|
|
$
|
(17,073,018
|
)
|
Net loss per share attributable to common stockholders — basic and diluted
|
$
|
(0.50
|
)
|
|
$
|
(0.51
|
)
|
|
$
|
(0.96
|
)
|
|
$
|
(1.00
|
)
|
Weighted-average number of common shares outstanding — basic and diluted
|
18,037,274
|
|
|
17,130,264
|
|
|
17,965,989
|
|
|
17,002,597
|
|
|
|
Three Months Ended June 30, 2018
|
|
Three Months Ended June 30, 2017
|
|
Six Months Ended June 30, 2018
|
|
Six Months Ended June 30, 2017
|
||||||||
Net loss
|
$
|
(9,051,872
|
)
|
|
$
|
(8,804,623
|
)
|
|
$
|
(17,275,099
|
)
|
|
$
|
(17,073,018
|
)
|
Other comprehensive gain (loss):
|
|
|
|
|
|
|
|
||||||||
Unrealized gain (loss) on available-for-sale securities
|
(93
|
)
|
|
6,737
|
|
|
1,247
|
|
|
(4,002
|
)
|
||||
Comprehensive loss
|
$
|
(9,051,965
|
)
|
|
$
|
(8,797,886
|
)
|
|
$
|
(17,273,852
|
)
|
|
$
|
(17,077,020
|
)
|
|
|
Six Months Ended June 30, 2018
|
|
Six Months Ended June 30, 2017
|
||||
Operating activities
|
|
|
|
|
|
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Net loss
|
$
|
(17,275,099
|
)
|
|
$
|
(17,073,018
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
||
Depreciation expense
|
124,000
|
|
|
171,109
|
|
||
Stock-based compensation expense
|
1,419,933
|
|
|
2,262,098
|
|
||
Amortization and accretion on investments
|
11,537
|
|
|
(15,895
|
)
|
||
Other non-cash items
|
22,274
|
|
|
—
|
|
||
Changes in operating assets and liabilities:
|
|
|
|
|
|||
Accounts receivable
|
(184
|
)
|
|
(22,554
|
)
|
||
Inventory
|
139,206
|
|
|
207,063
|
|
||
Prepaid expenses and other current assets
|
(93,909
|
)
|
|
(283,209
|
)
|
||
Other assets
|
—
|
|
|
64,800
|
|
||
Accounts payable
|
(859,107
|
)
|
|
601,646
|
|
||
Accrued expenses and other current liabilities
|
(1,127,164
|
)
|
|
101,705
|
|
||
Deferred revenue
|
—
|
|
|
8,323
|
|
||
Deferred rent
|
(29,410
|
)
|
|
62,385
|
|
||
Net cash used in operating activities
|
(17,667,923
|
)
|
|
(13,915,547
|
)
|
||
Investing activities
|
|
|
|
|
|
||
Purchases of marketable securities
|
(1,997,751
|
)
|
|
(9,607,390
|
)
|
||
Proceeds from maturities and sales of marketable securities
|
16,117,184
|
|
|
40,282,017
|
|
||
Purchases of property and equipment
|
—
|
|
|
(53,741
|
)
|
||
Proceeds from sales of property and equipment
|
1,415
|
|
|
3,375
|
|
||
Net cash provided by investing activities
|
14,120,848
|
|
|
30,624,261
|
|
||
Financing activities
|
|
|
|
|
|
||
Proceeds from exercise of common stock
|
118,010
|
|
|
2,047
|
|
||
Net cash provided by financing activities
|
118,010
|
|
|
2,047
|
|
||
Net increase (decrease) in cash, cash equivalents and restricted cash
|
(3,429,065
|
)
|
|
16,710,761
|
|
||
Cash, cash equivalents and restricted cash at beginning of period
|
19,312,631
|
|
|
22,542,635
|
|
||
Cash, cash equivalents and restricted cash at end of period
|
$
|
15,883,566
|
|
|
$
|
39,253,396
|
|
Supplemental cash flow information
|
|
|
|
||||
Inventory purchases included in accounts payable and accrued expense at June 30, 2017
|
$
|
—
|
|
|
$
|
441,116
|
|
Property and equipment purchases included in accounts payable at June 30, 2017
|
$
|
—
|
|
|
$
|
19,630
|
|
Property and equipment purchases included in accounts payable and accrued expenses at December 31, 2016
|
$
|
—
|
|
|
$
|
7,100
|
|
|
|
|
June 30, 2018
|
|
December 31, 2017
|
||||
Cash and cash equivalents
|
$
|
15,756,971
|
|
|
$
|
19,186,036
|
|
Restricted cash
|
126,595
|
|
|
126,595
|
|
||
Cash, cash equivalents and restricted cash shown on the condensed consolidated statement of cash flows
|
$
|
15,883,566
|
|
|
$
|
19,312,631
|
|
|
1.
|
Identify the contract with a customer
|
2.
|
Identify the performance obligations in the contract
|
3.
|
Determine the transaction price
|
4.
|
Determine the satisfaction of performance obligation
|
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Balance as of
June 30, 2018
|
||||||||
Cash equivalents
|
$
|
6,293,640
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
6,293,640
|
|
|
$
|
6,293,640
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
6,293,640
|
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Balance as of
December 31, 2017
|
||||||||
Cash equivalents
|
$
|
5,046,205
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
5,046,205
|
|
Marketable securities:
|
|
|
|
|
|
|
|
||||||||
U.S. government agency securities
|
—
|
|
|
8,986,259
|
|
|
—
|
|
|
8,986,259
|
|
||||
Commercial paper
|
—
|
|
|
4,440,689
|
|
|
—
|
|
|
4,440,689
|
|
||||
Corporate debt securities
|
—
|
|
|
702,775
|
|
|
—
|
|
|
702,775
|
|
||||
|
$
|
5,046,205
|
|
|
$
|
14,129,723
|
|
|
$
|
—
|
|
|
$
|
19,175,928
|
|
|
|
|
Amortized Cost
|
|
Unrealized Gains
|
|
Unrealized Losses
|
|
Fair Value
|
||||||||
As of December 31, 2017
|
|
|
|
|
|
|
|
||||||||
Current (due within 1 year):
|
|
|
|
|
|
|
|
||||||||
U.S. government agency securities
|
$
|
8,987,254
|
|
|
$
|
38
|
|
|
$
|
(1,033
|
)
|
|
$
|
8,986,259
|
|
Commercial paper
|
4,440,689
|
|
|
—
|
|
|
—
|
|
|
4,440,689
|
|
||||
Corporate debt securities
|
703,027
|
|
|
—
|
|
|
(252
|
)
|
|
702,775
|
|
||||
Total
|
$
|
14,130,970
|
|
|
$
|
38
|
|
|
$
|
(1,285
|
)
|
|
$
|
14,129,723
|
|
|
|
|
June 30, 2018
|
|
December 31, 2017
|
||||
Raw materials
|
$
|
7,240
|
|
|
$
|
17,411
|
|
Finished goods
|
268,453
|
|
|
414,480
|
|
||
Total inventory
|
$
|
275,693
|
|
|
$
|
431,891
|
|
|
|
|
June 30, 2018
|
|
December 31, 2017
|
||||
Phase 2 MND and CMT clinical trial-related costs
|
$
|
1,402,929
|
|
|
$
|
1,850,115
|
|
Restructuring-related costs
|
548,882
|
|
|
—
|
|
||
Payroll and other employee-related costs
|
313,794
|
|
|
874,246
|
|
||
Professional fees
|
157,262
|
|
|
227,980
|
|
||
Other research and development-related costs
|
146,895
|
|
|
652,285
|
|
||
Consumer product-related costs
|
18,834
|
|
|
107,595
|
|
||
Total
|
$
|
2,588,596
|
|
|
$
|
3,712,221
|
|
|
|
Opening balance
|
$
|
—
|
|
Charges:
|
|
||
Employee termination benefits
|
885,768
|
|
|
Employee retention benefits
|
17,602
|
|
|
Other
|
14,995
|
|
|
Payments
|
(369,483
|
)
|
|
Accrued restructuring balance as of June 30, 2018
|
$
|
548,882
|
|
|
|
|
Number of
Shares
|
|
Weighted-Average
Grant Date
Fair Value
|
|||
Unvested at December 31, 2017
|
169,654
|
|
|
$
|
0.10
|
|
Issued
|
—
|
|
|
—
|
|
|
Vested
|
(169,654
|
)
|
|
0.10
|
|
|
Forfeited
|
—
|
|
|
—
|
|
|
Unvested at June 30, 2018
|
—
|
|
|
$
|
—
|
|
|
|
|
Number of
Shares
|
|
Weighted-Average
Grant Date
Fair Value
|
|||
Unvested at December 31, 2017
|
5,334
|
|
|
$
|
10.51
|
|
Issued
|
—
|
|
|
—
|
|
|
Vested
|
(2,000
|
)
|
|
9.61
|
|
|
Forfeited
|
—
|
|
|
—
|
|
|
Unvested at June 30, 2018
|
3,334
|
|
|
$
|
11.05
|
|
|
|
|
Shares
|
|
Weighted-Average
Exercise Price
|
|
Weighted-Average
Remaining
Contractual
Term (in years)
|
|
Aggregate
Intrinsic Value |
|||||
Outstanding at December 31, 2017
|
2,580,491
|
|
|
$
|
6.65
|
|
|
7.55
|
|
$
|
803,600
|
|
Granted
|
1,467,544
|
|
|
2.81
|
|
|
|
|
|
|||
Exercised
|
(97,310
|
)
|
|
1.21
|
|
|
|
|
|
|||
Forfeited
|
(621,282
|
)
|
|
6.17
|
|
|
|
|
|
|||
Expired
|
(230,630
|
)
|
|
9.82
|
|
|
|
|
|
|||
Outstanding at June 30, 2018
|
3,098,813
|
|
|
$
|
4.86
|
|
|
7.35
|
|
$
|
42,136
|
|
Exercisable at June 30, 2018
|
1,440,107
|
|
|
$
|
6.72
|
|
|
4.99
|
|
$
|
42,136
|
|
Vested or expected to vest at June 30, 2018
|
3,098,813
|
|
|
$
|
4.86
|
|
|
7.35
|
|
$
|
42,136
|
|
|
|
|
Three Months Ended June 30, 2018
|
|
Three Months Ended June 30, 2017
|
|
Six Months Ended June 30, 2018
|
|
Six Months Ended June 30, 2017
|
||||||||
Research and development
|
$
|
244,869
|
|
|
$
|
391,602
|
|
|
$
|
631,406
|
|
|
$
|
786,019
|
|
Selling, general and administrative
|
266,124
|
|
|
681,744
|
|
|
788,527
|
|
|
1,476,079
|
|
||||
Total
|
$
|
510,993
|
|
|
$
|
1,073,346
|
|
|
$
|
1,419,933
|
|
|
$
|
2,262,098
|
|
|
|
|
June 30, 2018
|
|
June 30, 2017
|
||
Options to purchase common stock
|
3,098,813
|
|
|
2,668,187
|
|
Unvested restricted common stock
|
3,334
|
|
|
685,890
|
|
Total
|
3,102,147
|
|
|
3,354,077
|
|
|
•
|
The Consumer Operations segment, which reflects the total revenue and costs and expenses related to HOTSHOT and the Company's consumer operations.
|
•
|
The Drug Development segment, which reflects the costs and expenses related to the Company's efforts to develop innovative and proprietary drug products; previously to treat muscle cramps, spasms and spasticity
|
|
Three Months Ended June 30, 2018
|
Consumer Operations
|
Drug Development
|
Corporate
|
Consolidated
|
||||||
Total revenue
|
$
|
245,502
|
|
—
|
|
—
|
|
$
|
245,502
|
|
Interest income, net
|
$
|
—
|
|
—
|
|
51,809
|
|
$
|
51,809
|
|
Loss from operations
|
$
|
645,687
|
|
6,170,488
|
|
2,287,506
|
|
$
|
9,103,681
|
|
Three Months Ended June 30, 2017
|
Consumer Operations
|
Drug Development
|
Corporate
|
Consolidated
|
||||||
Total revenue
|
$
|
335,523
|
|
—
|
|
—
|
|
$
|
335,523
|
|
Interest income, net
|
$
|
—
|
|
—
|
|
72,342
|
|
$
|
72,342
|
|
Loss from operations
|
$
|
2,760,496
|
|
3,960,335
|
|
2,156,134
|
|
$
|
8,876,965
|
|
|
|
Six Months Ended June 30, 2018
|
Consumer Operations
|
Drug Development
|
Corporate
|
Consolidated
|
||||||
Total revenue
|
$
|
424,084
|
|
—
|
|
—
|
|
$
|
424,084
|
|
Interest income, net
|
$
|
—
|
|
—
|
|
111,402
|
|
$
|
111,402
|
|
Loss from operations
|
$
|
1,902,993
|
|
10,834,565
|
|
4,648,943
|
|
$
|
17,386,501
|
|
Six Months Ended June 30, 2017
|
Consumer Operations
|
Drug Development
|
Corporate
|
Consolidated
|
||||||
Total revenue
|
$
|
578,070
|
|
—
|
|
—
|
|
$
|
578,070
|
|
Interest income, net
|
$
|
—
|
|
—
|
|
150,196
|
|
$
|
150,196
|
|
Loss from operations
|
$
|
4,748,306
|
|
7,788,616
|
|
4,686,292
|
|
$
|
17,223,214
|
|
|
Item 2.
|
Management’s Discussion and Analysis of Financial Condition and Results of Operations
|
•
|
The Consumer Operations segment, which reflects the total revenue and costs and expense for HOTSHOT and our consumer operations, and
|
•
|
The Drug Development segment, which reflects the costs and expenses related to the Company's efforts to develop innovative and proprietary drug products; previously to treat muscle cramps, spasms and spasticity associated with severe neurological conditions and currently to assess the potential of FLX-787 in dysphagia.
|
|
|
Three Months Ended June 30, 2018
|
|
Three Months Ended June 30, 2017
|
|
Change
|
|||||||||
$
|
|
%
|
||||||||||||
Net product revenue
|
$
|
241,416
|
|
|
$
|
330,688
|
|
|
$
|
(89,272
|
)
|
|
(27
|
)%
|
Other revenue
|
4,086
|
|
|
4,835
|
|
|
(749
|
)
|
|
(15
|
)%
|
|||
Total revenue
|
245,502
|
|
|
335,523
|
|
|
(90,021
|
)
|
|
(27
|
)%
|
|||
Costs and expenses:
|
|
|
|
|
|
|
|
|
||||||
Cost of product revenue
|
179,945
|
|
|
145,325
|
|
|
34,620
|
|
|
24
|
%
|
|||
Research and development
|
6,174,589
|
|
|
4,076,220
|
|
|
2,098,369
|
|
|
51
|
%
|
|||
Selling, general and administrative
|
2,994,649
|
|
|
4,990,943
|
|
|
(1,996,294
|
)
|
|
(40
|
)%
|
|||
Total costs and expenses
|
9,349,183
|
|
|
9,212,488
|
|
|
136,695
|
|
|
1
|
%
|
|||
Loss from operations
|
(9,103,681
|
)
|
|
(8,876,965
|
)
|
|
(226,716
|
)
|
|
3
|
%
|
|||
Interest income, net
|
51,809
|
|
|
72,342
|
|
|
(20,533
|
)
|
|
(28
|
)%
|
|||
Net loss
|
$
|
(9,051,872
|
)
|
|
$
|
(8,804,623
|
)
|
|
$
|
(247,249
|
)
|
|
3
|
%
|
|
•
|
$1.3 million increase in clinical trial costs, primarily related to our Phase 2 clinical trials of FLX-787 in MND and CMT in the United States, which commenced during the first quarter of 2017 with start-up activities, increased in activity from mid-2017 through May 2018, and incurred increased expense for close out activities in June 2018 due to the decision to end our Phase 2 clinical trials;
|
•
|
$0.5 million increase in manufacturing and formulation of drug product to support clinical studies, incurred prior to the decision to end our Phase 2 clinical trials and related drug development work;
|
•
|
$0.5 million increase in salary and benefit costs mainly due to restructuring-related expenses, including termination benefit expenses, incurred in the second quarter of 2018; and
|
•
|
$0.2 million decrease related to stock-based compensation expense, related primarily to the final vesting of restricted common stock issued to the founders in 2014 during the first quarter of 2018.
|
•
|
$1.3 million decrease in marketing and consulting costs within our Consumer Operations segment for HOTSHOT due to decreased activity;
|
•
|
$0.4 million decrease in stock-based compensation expense, related primarily to a decrease in headcount compared to the prior year, as well as final vesting of restricted common stock issued to the founders in 2014 during the first quarter of 2018;
|
•
|
$0.2 million decrease related to salaries and benefits as Consumer Operations and corporate headcount decreased from the prior year, partially offset by restructuring-related expenses incurred in the second quarter of 2018;
|
•
|
$0.1 million decrease in employee travel and recruiting costs, related to decreased Consumer Operations and corporate headcount from the prior year;
|
•
|
$0.1 million decrease in rent, office and other expenses primarily due to the termination of our lease agreement for our office in New York, NY in the third quarter of 2017;
|
•
|
$0.1 million decrease in HOTSHOT product sampling within our Consumer Operations segment due to decreased marketing events; and
|
•
|
$0.2 million increase in consulting, legal and professional expenses to supplement our corporate personnel.
|
|
|
Six Months Ended June 30, 2018
|
|
Six Months Ended June 30, 2017
|
|
Change
|
|||||||||
$
|
|
%
|
||||||||||||
Net product revenue
|
$
|
417,671
|
|
|
$
|
570,980
|
|
|
$
|
(153,309
|
)
|
|
(27
|
)%
|
Other revenue
|
6,413
|
|
|
7,090
|
|
|
(677
|
)
|
|
(10
|
)%
|
|||
Total revenue
|
424,084
|
|
|
578,070
|
|
|
(153,986
|
)
|
|
(27
|
)%
|
|||
Costs and expenses:
|
|
|
|
|
|
|
|
|
|
|||||
Cost of product revenue
|
263,879
|
|
|
224,431
|
|
|
39,448
|
|
|
18
|
%
|
|||
Research and development
|
10,854,770
|
|
|
7,991,194
|
|
|
2,863,576
|
|
|
36
|
%
|
|||
Selling, general and administrative
|
6,691,936
|
|
|
9,585,659
|
|
|
(2,893,723
|
)
|
|
(30
|
)%
|
|||
Total costs and expenses
|
17,810,585
|
|
|
17,801,284
|
|
|
9,301
|
|
|
—
|
%
|
|||
Loss from operations
|
(17,386,501
|
)
|
|
(17,223,214
|
)
|
|
(163,287
|
)
|
|
1
|
%
|
|||
Interest income, net
|
111,402
|
|
|
150,196
|
|
|
(38,794
|
)
|
|
(26
|
)%
|
|||
Net loss
|
$
|
(17,275,099
|
)
|
|
$
|
(17,073,018
|
)
|
|
$
|
(202,081
|
)
|
|
1
|
%
|
|
•
|
$2.9 million increase in clinical activities and related work, primarily related to clinical trial costs for our Phase 2 clinical trials of FLX-787 in MND and CMT in the United States, which commenced during the first quarter of 2017 with start-up activities, increased in activity from mid-2017 through May 2018, and incurred increased expense in June 2018 due to the decision to end our Phase 2 clinical trials;
|
•
|
$0.4 million increase related to salaries and benefits, mainly due to restructuring-related expenses, including termination benefit expenses, incurred during the second quarter of 2018;
|
•
|
$0.3 million decrease in consulting expenses as we increased the use of consultants in the prior year to assist with our investigational new drug application and other research activities in 2017; and
|
•
|
$0.1 million decrease related to stock-based compensation expense, related primarily to the final vesting of restricted common stock issued to the founders in 2014 during the first quarter of 2018.
|
•
|
$1.4 million of decreased marketing and consulting costs within our Consumer Operations segment for HOTSHOT due to decreased activity during the strategic assessment;
|
•
|
$1.0 million decrease related to salaries and benefits, as Consumer Operations and corporate headcount decreased from the prior year, including executive level employees, partially offset by restructuring-related expenses, including termination benefit expenses, incurred during the second quarter of 2018;
|
•
|
$0.7 million decrease in stock-based compensation expense, related primarily to a decrease in headcount compared to the prior year and the final vesting of restricted common stock issued to the founders in 2014 during the first quarter of 2018;
|
•
|
$0.2 million decrease in employee travel and recruiting costs, related to decreased Consumer Operations and corporate headcount from the prior year;
|
•
|
$0.2 million decrease in rent, office and other expenses due to the termination of our lease agreement for our office in New York, NY in the third quarter of 2017; and
|
•
|
$0.6 million increase in consulting, legal and professional expenses to supplement our corporate personnel.
|
|
|
Six Months Ended June 30, 2018
|
|
Six Months Ended June 30, 2017
|
||||
Net cash (used in) provided by:
|
|
|
|
|
|
||
Operating activities
|
$
|
(17,667,923
|
)
|
|
$
|
(13,915,547
|
)
|
Investing activities
|
14,120,848
|
|
|
30,624,261
|
|
||
Financing activities
|
118,010
|
|
|
2,047
|
|
||
Net increase (decrease) in cash and cash equivalents
|
$
|
(3,429,065
|
)
|
|
$
|
16,710,761
|
|
|
•
|
receiving regulatory approval to conduct clinical trials;
|
•
|
successfully enrolling, and completing, clinical trials;
|
•
|
receiving marketing approvals from applicable regulatory authorities;
|
•
|
establishing arrangements with third-party manufacturers;
|
•
|
obtaining and maintaining patent and trade secret protection and regulatory exclusivity; and
|
•
|
launching commercial sales of our products, if and when approved, whether alone or in collaboration with others.
|
Item 3.
|
Quantitative and Qualitative Disclosures about Market Risk
|
Item 4.
|
Controls and Procedures
|
Item 1.
|
Legal Proceedings
|
Item 1A.
|
Risk Factors
|
Item 2.
|
Unregistered Sales of Equity Securities and Use of Proceeds
|
Item 3.
|
Defaults Upon Senior Securities
|
Item 4.
|
Mine Safety Disclosures
|
Item 5.
|
Other Information
|
Item 6.
|
Exhibits
|
Exhibit
number
|
|
Description of Document
|
|
|
|
|
|
3.1
|
|
(1)
|
|
|
|
|
|
3.2
|
|
(2)
|
|
|
|
|
|
4.1
|
|
(3)
|
|
|
|
|
|
4.2
|
|
(4)
|
|
|
|
|
|
10.1
|
|
+
|
|
|
|
|
|
10.2
|
|
+
|
|
|
|
|
|
10.3
|
|
+
|
|
|
|
|
|
10.4
|
|
+
|
|
|
|
|
|
31.1
|
|
|
|
|
|
|
|
31.2
|
|
|
|
|
|
|
|
32.1
|
|
|
|
|
|
|
|
101
|
|
|
The following materials from Flex Pharma, Inc.'s Quarterly Report on Form 10-Q for the quarter ended June 30, 2018, formatted in XBRL (eXtensible Business Reporting Language):(i) Unaudited Condensed Consolidated Balance Sheets, (ii) Unaudited Condensed Consolidated Statements of Operations (iii) Unaudited Condensed Consolidated Statements of Comprehensive Loss, (iv) Unaudited Condensed Consolidated Statements of Cash Flows, and (v) Notes to Unaudited Condensed Consolidated Financial Statements.
|
|
|
|
|
FLEX PHARMA, INC.
|
||
|
|
|
|
|
|
|
|
|
By:
|
|
/s/ William McVicar
|
|
|
|
|
|
William McVicar, Ph.D.
President and Chief Executive Officer (Principal Executive Officer)
|
|
|
|
|
|
|
|
|
|
By:
|
|
/s/ John McCabe
|
|
|
|
|
|
John McCabe
Chief Financial Officer (Principal Financial and Accounting Officer)
|
Date:
|
August 1, 2018
|
|
|
|
|
1 Year FLEX PHARMA, INC. Chart |
1 Month FLEX PHARMA, INC. Chart |
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