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x
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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¨
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Delaware
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26-1824804
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(State or other jurisdiction of
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(I.R.S. Employer
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incorporation or organization)
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Identification No.)
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Large accelerated filer
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¨
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Accelerated filer
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¨
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Non-accelerated filer
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x
(Do not check if a smaller reporting company)
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Smaller reporting company
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¨
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Emerging growth company
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x
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Page
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June 30,
|
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December 31,
|
||||
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|
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2017
|
|
2016
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||||
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Assets
|
|
(unaudited)
|
|
|
||||
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Current Assets:
|
|
|
|
|
||||
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Cash and cash equivalents
|
|
$
|
15,219
|
|
|
$
|
16,432
|
|
|
Short-term marketable securities
|
|
32,502
|
|
|
44,066
|
|
||
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Prepaid expenses and other current assets
|
|
387
|
|
|
882
|
|
||
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Total current assets
|
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48,108
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|
|
61,380
|
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||
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Property and equipment, net
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13
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|
|
354
|
|
||
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Restricted cash
|
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—
|
|
|
2,432
|
|
||
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Total assets
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$
|
48,121
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|
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$
|
64,166
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Liabilities and Stockholders’ Equity (Deficit)
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||||
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Current Liabilities:
|
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|
|
|
||||
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Accounts payable
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|
$
|
47
|
|
|
$
|
361
|
|
|
Accrued expenses
|
|
1,375
|
|
|
2,400
|
|
||
|
Total current liabilities
|
|
1,422
|
|
|
2,761
|
|
||
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Lease obligations, long-term
|
|
—
|
|
|
1,053
|
|
||
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Total liabilities
|
|
1,422
|
|
|
3,814
|
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||
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|
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||||
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Stockholders’ Equity (Deficit):
|
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|
|
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||||
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Preferred stock, $0.001 par value, 5,000,000 shares authorized at June 30, 2017 and December 31, 2016; 0 shares outstanding at June 30, 2017 and December 31, 2016
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—
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|
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—
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|
||
|
Common stock, $0.001 par value; 250,000,000 shares authorized at June 30, 2017 and December 31, 2016; 20,856,693 and 20,841,393 shares issued and outstanding at June 30 and December 31, 2016, respectively
|
|
21
|
|
|
21
|
|
||
|
Additional paid in capital
|
|
163,847
|
|
|
163,126
|
|
||
|
Accumulated deficit
|
|
(117,152
|
)
|
|
(102,791
|
)
|
||
|
Other comprehensive loss
|
|
(17
|
)
|
|
(4
|
)
|
||
|
Total stockholders’ equity
|
|
46,699
|
|
|
60,352
|
|
||
|
Total liabilities and stockholders’ equity
|
|
$
|
48,121
|
|
|
$
|
64,166
|
|
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||||||
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2017
|
|
2016
|
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2017
|
|
2016
|
||||||||
|
Operating expenses:
|
|
|
|
|
|
|
|
|
||||||||
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Research and development
|
|
$
|
5,079
|
|
|
$
|
3,682
|
|
|
$
|
5,321
|
|
|
$
|
8,205
|
|
|
General and administrative
|
|
4,232
|
|
|
2,049
|
|
|
6,496
|
|
|
4,179
|
|
||||
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Restructuring charges
|
|
165
|
|
|
—
|
|
|
2,723
|
|
|
—
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||||
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Total operating expenses
|
|
9,476
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|
|
5,731
|
|
|
14,540
|
|
|
12,384
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|
||||
|
Other income:
|
|
|
|
|
|
|
|
|
||||||||
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Interest income
|
|
95
|
|
|
93
|
|
|
182
|
|
|
175
|
|
||||
|
Net loss attributable to common stockholders
|
|
$
|
(9,381
|
)
|
|
$
|
(5,638
|
)
|
|
$
|
(14,358
|
)
|
|
$
|
(12,209
|
)
|
|
Other comprehensive loss:
|
|
|
|
|
|
|
|
|
||||||||
|
Unrealized gain/ (loss) on available for sale securities, net of tax
|
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—
|
|
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(3
|
)
|
|
(13
|
)
|
|
6
|
|
||||
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Total other comprehensive loss
|
|
(9,381
|
)
|
|
(5,641
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)
|
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(14,371
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)
|
|
(12,203
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)
|
||||
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Net loss per share attributable to common stockholders—basic and diluted
|
|
$
|
(0.45
|
)
|
|
$
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(0.27
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)
|
|
$
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(0.69
|
)
|
|
$
|
(0.59
|
)
|
|
Common shares used to compute basic and diluted net loss per share attributable to common stockholders
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|
20,856,693
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|
|
20,831,723
|
|
|
20,853,628
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|
|
20,831,139
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||||
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|
|
Six Months Ended
June 30, |
||||||
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2017
|
|
2016
|
||||
|
Operating activities
|
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|
|
|
||||
|
Net loss
|
|
$
|
(14,358
|
)
|
|
$
|
(12,209
|
)
|
|
Adjustment to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
||||
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Restructuring charges
|
|
2,723
|
|
|
—
|
|
||
|
Depreciation and amortization
|
|
18
|
|
|
45
|
|
||
|
Stock-based compensation
|
|
693
|
|
|
689
|
|
||
|
Net amortization of premium/ discounts on marketable securities
|
|
127
|
|
|
98
|
|
||
|
Changes in operating assets and liabilities:
|
|
|
|
|
||||
|
Prepaid expenses and other assets
|
|
496
|
|
|
(118
|
)
|
||
|
Accounts payable
|
|
(314
|
)
|
|
(2,584
|
)
|
||
|
Accrued expenses
|
|
(4,801
|
)
|
|
(21
|
)
|
||
|
Net cash used in operating activities
|
|
(15,416
|
)
|
|
(14,100
|
)
|
||
|
Investing activities
|
|
|
|
|
||||
|
Purchases of marketable securities
|
|
(27,528
|
)
|
|
(50,848
|
)
|
||
|
Maturities of marketable securities
|
|
38,952
|
|
|
9,000
|
|
||
|
Change in restricted cash
|
|
2,432
|
|
|
(2,430
|
)
|
||
|
Proceeds from the sale of equipment
|
|
325
|
|
|
—
|
|
||
|
Purchases of property and equipment
|
|
(3
|
)
|
|
(548
|
)
|
||
|
Net cash provided by/ (used in) investing activities
|
|
14,178
|
|
|
(44,826
|
)
|
||
|
Financing activities
|
|
|
|
|
||||
|
Proceeds from the exercise of stock options
|
|
25
|
|
|
9
|
|
||
|
Cash provided by financing activities
|
|
25
|
|
|
9
|
|
||
|
Net decrease in cash and cash equivalents
|
|
(1,213
|
)
|
|
(58,917
|
)
|
||
|
Cash and cash equivalents at beginning of period
|
|
16,432
|
|
|
89,713
|
|
||
|
Cash and cash equivalents at end of period
|
|
$
|
15,219
|
|
|
$
|
30,796
|
|
|
•
|
Level 1 – Unadjusted prices in active markets for identical assets or liabilities.
|
|
•
|
Level 2 – Quoted prices for similar assets and liabilities in active markets, quoted prices in markets that are not active, or inputs which are observable, either directly or indirectly, for substantially the full term of the asset or liability.
|
|
•
|
Level 3 – Unobservable inputs that reflect the Company’s own assumptions about the assumptions market participants would use in pricing the asset or liability in which there is little, if any, market activity for the asset or liability at the measurement date.
|
|
|
|
Amortized Cost
|
|
Unrealized Gains
|
|
Unrealized Losses
|
|
Fair Value
|
||||||||
|
June 30, 2017
|
|
|
|
|
|
|
|
|
||||||||
|
U.S. government agency securities and treasuries
|
|
$
|
32,519
|
|
|
$
|
—
|
|
|
$
|
(17
|
)
|
|
$
|
32,502
|
|
|
Total available-for-sale securities
|
|
$
|
32,519
|
|
|
$
|
—
|
|
|
$
|
(17
|
)
|
|
$
|
32,502
|
|
|
|
|
Amortized Cost
|
|
Unrealized Gains
|
|
Unrealized Losses
|
|
Fair Value
|
||||||||
|
December 31, 2016
|
|
|
|
|
|
|
|
|
||||||||
|
U.S. government agency securities and treasuries
|
|
$
|
42,516
|
|
|
$
|
4
|
|
|
$
|
(8
|
)
|
|
$
|
42,512
|
|
|
Corporate debt securities
|
|
1,554
|
|
|
—
|
|
|
—
|
|
|
1,554
|
|
||||
|
Total available-for-sale securities
|
|
$
|
44,070
|
|
|
$
|
4
|
|
|
$
|
(8
|
)
|
|
$
|
44,066
|
|
|
|
|
Total
|
|
Quoted
prices in active markets (Level 1) |
|
Significant
other observable inputs (Level 2) |
|
Significant
unobservable inputs (Level 3) |
||||||||
|
June 30, 2017
|
|
|
|
|
|
|
|
|
||||||||
|
Assets:
|
|
|
|
|
|
|
|
|
||||||||
|
Cash and cash equivalents
|
|
|
|
|
|
|
|
|
||||||||
|
Cash
|
|
$
|
4,061
|
|
|
$
|
4,061
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
Money market funds
|
|
$
|
11,158
|
|
|
$
|
11,158
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
Total cash and cash equivalents
|
|
15,219
|
|
|
15,219
|
|
|
—
|
|
|
—
|
|
||||
|
Marketable securities
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
U.S. government agency securities and treasuries
|
|
32,502
|
|
|
—
|
|
|
32,502
|
|
|
—
|
|
||||
|
Total fair value financial instruments
|
|
$
|
47,721
|
|
|
$
|
15,219
|
|
|
$
|
32,502
|
|
|
$
|
—
|
|
|
|
|
Total
|
|
Quoted
prices in active markets (Level 1) |
|
Significant
other observable inputs (Level 2) |
|
Significant
unobservable inputs (Level 3) |
||||||||
|
December 31, 2016
|
|
|
|
|
|
|
|
|
||||||||
|
Assets:
|
|
|
|
|
|
|
|
|
||||||||
|
Cash and cash equivalents
|
|
|
|
|
|
|
|
|
||||||||
|
Cash
|
|
$
|
2,785
|
|
|
$
|
2,785
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
Money market funds
|
|
$
|
9,647
|
|
|
$
|
9,647
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
US government agency securities and treasuries
|
|
$
|
4,000
|
|
|
—
|
|
|
4,000
|
|
|
|
|
|||
|
Total cash and cash equivalents
|
|
16,432
|
|
|
12,432
|
|
|
4,000
|
|
|
—
|
|
||||
|
Marketable securities
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
U.S. government agency securities and treasuries
|
|
42,512
|
|
|
—
|
|
|
42,512
|
|
|
—
|
|
||||
|
Corporate debt securities
|
|
1,554
|
|
|
—
|
|
|
1,554
|
|
|
—
|
|
||||
|
Total marketable securities
|
|
44,066
|
|
|
—
|
|
|
44,066
|
|
|
—
|
|
||||
|
Restricted cash
|
|
2,432
|
|
|
2,432
|
|
|
—
|
|
|
—
|
|
||||
|
Total fair value financial instruments
|
|
$
|
62,930
|
|
|
$
|
14,864
|
|
|
$
|
48,066
|
|
|
$
|
—
|
|
|
|
|
June 30,
2017 |
|
December 31,
2016 |
||||
|
Furniture, computers and equipment
|
|
$
|
44
|
|
|
$
|
385
|
|
|
Accumulated depreciation
|
|
(31
|
)
|
|
(31
|
)
|
||
|
|
|
$
|
13
|
|
|
354
|
|
|
|
•
|
The holders of shares of common stock are entitled to
one
vote for each share of common stock held at all meetings of stockholders.
|
|
•
|
The holders of shares of common stock are entitled to receive dividends, if and when declared by the Company’s board of directors. Since inception,
no
cash dividends have been declared.
|
|
|
|
|
|
Weighted‑
|
|
|
|||
|
|
|
|
|
Average
|
|
Weighted‑Average
|
|||
|
|
|
Number
|
|
Exercise
|
|
Contractual
|
|||
|
|
|
of Shares
|
|
Price
|
|
Life (years)
|
|||
|
Outstanding at December 31, 2016
|
|
1,905,214
|
|
|
$
|
5.39
|
|
|
7.49
|
|
Granted
|
|
—
|
|
|
—
|
|
|
|
|
|
Exercised
|
|
(15,300
|
)
|
|
1.65
|
|
|
|
|
|
Forfeited/canceled
|
|
(302,040
|
)
|
|
5.46
|
|
|
|
|
|
Outstanding at June 30, 2017
|
|
1,587,874
|
|
|
$
|
5.41
|
|
|
7.80
|
|
Options exercisable at June 30, 2017
|
|
1,134,680
|
|
|
$
|
5.24
|
|
|
7.58
|
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||||||
|
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
|
Research and development expense
|
|
$
|
30
|
|
|
$
|
(56
|
)
|
|
$
|
71
|
|
|
$
|
115
|
|
|
General and administrative expense
|
|
299
|
|
|
298
|
|
|
622
|
|
|
574
|
|
||||
|
Total stock based compensation
|
|
$
|
329
|
|
|
$
|
242
|
|
|
$
|
693
|
|
|
$
|
689
|
|
|
|
Three months ended June 30,
|
|
Six months ended June 30,
|
||||||||||
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||
|
Employee severance and related costs
|
$
|
43
|
|
|
—
|
|
|
$
|
248
|
|
|
—
|
|
|
Contract termination costs
|
122
|
|
|
—
|
|
|
2,475
|
|
|
—
|
|
||
|
Total restructuring charges
|
$
|
165
|
|
|
—
|
|
|
$
|
2,723
|
|
|
—
|
|
|
|
Employee severance and related costs
|
Contract Termination Costs
|
Total
|
|
|||||
|
Balance at December 31, 2016
|
$
|
1,097
|
|
$
|
1,565
|
|
$
|
2,662
|
|
|
Restructuring charges and adjustments
|
248
|
|
2,475
|
|
2,723
|
|
|||
|
Cash payments
|
(1,234
|
)
|
(4,040
|
)
|
(5,274
|
)
|
|||
|
Balance at June 30, 2017
|
$
|
111
|
|
$
|
—
|
|
$
|
111
|
|
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
|||||||||||||
|
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
|||||||||
|
Net loss attributable to common stockholders—basic and diluted
|
|
$
|
(9,381
|
)
|
|
(5,638
|
)
|
|
$
|
(14,358
|
)
|
—
|
|
(12,209
|
)
|
||
|
Weighted-average number of common shares—basic and diluted
|
|
20,856,693
|
|
|
20,831,723
|
|
|
20,853,628
|
|
|
20,831,139
|
|
|||||
|
Net loss per share attributable to common stockholders—basic and diluted
|
|
$
|
(0.45
|
)
|
|
$
|
(0.27
|
)
|
|
$
|
(0.69
|
)
|
|
$
|
(0.59
|
)
|
|
|
•
|
employee‑related expenses, including salaries, benefits, travel and stock‑based compensation;
|
|
•
|
external research and development expenses incurred under arrangements with third parties, such as contract research organizations (“CROs”), consultants and our scientific advisory board;
|
|
•
|
lab supplies, and acquiring, developing and manufacturing preclinical study materials in accordance with Good Laboratory Practices;
|
|
•
|
costs of clinical trials, including costs for management, investigator fees and related vendors that provide services for the clinical trials;
|
|
•
|
costs to manufacture the drug used in the clinical trials in accordance with Good Manufacturing Practices;
|
|
•
|
license and milestone fees;
|
|
•
|
development and prosecution of intellectual property; and
|
|
•
|
costs of facilities, depreciation and other expenses.
|
|
|
|
Three Months Ended
June 30, |
|
Dollar
|
|
|
|||||||||
|
|
|
2017
|
|
2016
|
|
Change
|
|
% Change
|
|||||||
|
|
|
(in thousands)
|
|||||||||||||
|
Statement of operations data:
|
|
|
|
|
|
|
|
|
|||||||
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|||||||
|
Research and development
|
|
$
|
5,079
|
|
|
$
|
3,682
|
|
|
$
|
1,397
|
|
|
37.9
|
%
|
|
General and administrative
|
|
4,232
|
|
|
2,049
|
|
|
2,183
|
|
|
106.5
|
%
|
|||
|
Restructuring charges
|
|
165
|
|
|
—
|
|
|
165
|
|
|
100.0
|
%
|
|||
|
Interest (income)
|
|
(95
|
)
|
|
(93
|
)
|
|
(2
|
)
|
|
2.2
|
%
|
|||
|
Net loss
|
|
$
|
9,381
|
|
|
$
|
5,638
|
|
|
$
|
3,743
|
|
|
66.4
|
%
|
|
|
|
Six Months Ended
June 30, |
|
Dollar
|
|
|
|||||||||
|
|
|
2017
|
|
2016
|
|
Change
|
|
% Change
|
|||||||
|
|
|
(in thousands)
|
|||||||||||||
|
Statement of operations data:
|
|
|
|
|
|
|
|
|
|||||||
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|||||||
|
Research and development
|
|
$
|
5,321
|
|
|
$
|
8,205
|
|
|
$
|
(2,884
|
)
|
|
(35.1
|
)%
|
|
General and administrative
|
|
6,496
|
|
|
4,179
|
|
|
2,317
|
|
|
55.4
|
%
|
|||
|
Restructuring charges
|
|
2,723
|
|
|
—
|
|
|
2,723
|
|
|
100.0
|
%
|
|||
|
Interest (income)
|
|
(182
|
)
|
|
(175
|
)
|
|
(7
|
)
|
|
4.0
|
%
|
|||
|
Net loss
|
|
$
|
14,358
|
|
|
$
|
12,209
|
|
|
$
|
2,149
|
|
|
17.6
|
%
|
|
•
|
our ability to consummate the Merger;
|
|
•
|
if the Merger is not completed, the timing and nature of any other strategic transactions that we undertake;
|
|
•
|
whether we enter into a partnership or business combination;
|
|
•
|
our ability to establish and maintain collaboration partnerships, in-license/out-license or other similar arrangements and the financial terms of such agreements; and
|
|
•
|
the cost incurred in responding to disruptive actions by activist stockholders.
|
|
|
|
Six Months Ended
June 30, |
||||||
|
|
|
2017
|
|
2016
|
||||
|
|
|
(in thousands)
|
||||||
|
Net cash provided by (used in):
|
|
|
|
|
||||
|
Operating activities
|
|
(15,416
|
)
|
|
$
|
(14,100
|
)
|
|
|
Investing activities
|
|
14,178
|
|
|
(44,826
|
)
|
||
|
Financing activities
|
|
25
|
|
|
9
|
|
||
|
Net increase (decrease)
|
|
$
|
(1,213
|
)
|
|
$
|
(58,917
|
)
|
|
•
|
if the Merger Agreement is terminated under certain circumstances, we will be required to pay certain transaction expenses of Synlogic, up to a maximum of $1.0 million;
|
|
•
|
if the Merger Agreement is terminated under certain circumstances, we will be required to pay Synlogic a termination fee of $2.0 million, plus certain transaction expenses of Synlogic;
|
|
•
|
the price of our common stock may decline and remain volatile; and
|
|
•
|
costs related to the Merger, such as legal and accounting fees, which we estimate will total approximately $6.8 million, some of which must be paid even if the Merger is not completed.
|
|
•
|
any rejection or non-acceptance by a governmental body of a registration or filing by us or Synlogic relating to certain intellectual property rights of us or Synlogic;
|
|
•
|
the taking of any action, or the failure to take any action, by either us or Synlogic required to comply with the terms of the Merger Agreement;
|
|
•
|
any effect resulting from the announcement or pendency of the Merger or any related transactions;
|
|
•
|
any natural disaster or any act or threat of terrorism or war anywhere in the world, any armed hostilities or terrorist activities anywhere in the world, any threat or escalation or armed hostilities or terrorist activities anywhere in the world or any governmental or other response or reaction to any of the foregoing;
|
|
•
|
any change in accounting requirements or principles of any change in applicable laws, rules or regulations or the interpretation thereof;
|
|
•
|
any general economic or political conditions or conditions generally affecting the industries in which we and Synlogic operate;
|
|
•
|
with respect to us, any change in the stock price or trading volume of our common stock excluding any underlying effect that may have caused such change; and
|
|
•
|
with respect to Synlogic, any change in the cash position of Synlogic that results from operations in the ordinary course of business.
|
|
•
|
investors react negatively to the prospects of the combined organization’s business and prospects from the Merger;
|
|
•
|
the effect of the Merger on the combined organization’s business and prospects is not consistent with
|
|
•
|
the expectations of financial or industry analysts; or
|
|
•
|
the combined organization does not achieve the perceived benefits of the Merger as rapidly or to the extent anticipated by financial or industry analysts.
|
|
•
|
initiation of investigations by regulators;
|
|
•
|
substantial costs of litigation, including monetary awards to patients or other claimants;
|
|
•
|
liabilities that substantially exceed our product liability insurance, which we would then be required to pay;
|
|
•
|
an increase in our product liability insurance rates or the inability to maintain insurance coverage in the future on acceptable terms, if at all;
|
|
•
|
the diversion of management’s attention from our business; and
|
|
•
|
damage to our reputation and the reputation of our products and technology.
|
|
•
|
collaborators often have significant discretion in determining the efforts and resources that they will apply to the collaboration, and may not commit sufficient resources to the development, marketing or commercialization of the product or products that are subject to the collaboration;
|
|
•
|
collaborators may not perform their obligations as expected;
|
|
•
|
any such collaboration may require us to relinquish potentially valuable rights to its current product candidates, potential products or proprietary technologies or grant licenses on terms that are not favorable to us;
|
|
•
|
collaborators may cease to devote resources to the development or commercialization of our product candidates if the collaborators view our product candidates as competitive with their own products or product candidates;
|
|
•
|
disagreements with collaborators, including disagreements over proprietary rights, contract interpretation or the course of development, might cause delays or termination of the development or commercialization of product candidates, and might result in legal proceedings, which would be time consuming, distracting and expensive;
|
|
•
|
collaborators may be impacted by changes in their strategic focus or available funding, or business combinations involving them, which could cause them to divert resources away from the collaboration;
|
|
•
|
collaborators may infringe the intellectual property rights of third parties, which may expose us to litigation and potential liability;
|
|
•
|
the collaborations may not result in us achieving revenues to justify such transactions; and
|
|
•
|
collaborations may be terminated and, if terminated, may result in a need for us to raise additional capital to resume further development or commercialization of the applicable product candidate.
|
|
•
|
terminate agreements, in whole or in part, for any reason or no reason;
|
|
•
|
reduce or modify the government’s obligations under such agreements without the consent of the other party;
|
|
•
|
claim rights, including intellectual property rights, in products and data developed under such agreements;
|
|
•
|
audit contract-related costs and fees, including allocated indirect costs;
|
|
•
|
suspend the contractor or grantee from receiving new contracts pending resolution of alleged violations of procurement laws or regulations;
|
|
•
|
impose U.S. manufacturing requirements for products that embody inventions conceived or first reduced to practice under such agreements;
|
|
•
|
impose qualifications for the engagement of manufacturers, suppliers and other contractors as well as other criteria for reimbursements;
|
|
•
|
suspend or debar the contractor or grantee from doing future business with the government;
|
|
•
|
control and potentially prohibit the export of products;
|
|
•
|
pursue criminal or civil remedies under the False Claims Act, False Statements Act and similar remedy provisions specific to government agreements; and
|
|
•
|
limit the government’s financial liability to amounts appropriated by the U.S. Congress on a fiscal year basis, thereby leaving some uncertainty about the future availability of funding for a program even after it has been funded for an initial period.
|
|
•
|
specialized accounting systems unique to government contracts and grants;
|
|
•
|
mandatory financial audits and potential liability for price adjustments or recoupment of government funds after such funds have been spent;
|
|
•
|
public disclosures of certain contract and grant information, which may enable competitors to gain insights into our research program; and
|
|
•
|
mandatory socioeconomic compliance requirements, including labor standards, nondiscrimination and affirmative action programs and environmental compliance requirements.
|
|
•
|
the scope of rights granted under the license agreement and other interpretation related issues;
|
|
•
|
whether and the extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement;
|
|
•
|
our right to sublicense patent and other rights to third parties under collaborative development relationships;
|
|
•
|
our diligence obligations with respect to the use of the licensed technology in relation to our development and commercialization of its product candidates, and what activities satisfy those diligence obligations; and
|
|
•
|
the ownership of inventions and know how resulting from the joint creation or use of intellectual property by our licensors and us and our partners.
|
|
•
|
announcements relating to the Merger or any other strategic transaction;
|
|
•
|
announcements relating to collaborations that we may enter into with respect to the development or commercialization of our product candidates;
|
|
•
|
announcements relating to the receipt, modification or termination of government contracts or grants;
|
|
•
|
product liability claims related to our clinical trials or product candidates;
|
|
•
|
prevailing economic conditions;
|
|
•
|
additions or departures of key personnel;
|
|
•
|
business disruptions caused by earthquakes or other natural disasters;
|
|
•
|
disputes concerning our intellectual property or other proprietary rights;
|
|
•
|
FDA or other U.S. or foreign regulatory actions affecting us or our industry;
|
|
•
|
sales of our common stock by us, our executive officers and directors or our stockholders in the future;
|
|
•
|
future sales or issuances of equity or debt securities by us;
|
|
•
|
lack of an active, liquid and orderly market in our common stock;
|
|
•
|
fluctuations in our quarterly operating results; and
|
|
•
|
the issuance of new or changed securities analysts’ reports or recommendations regarding us.
|
|
•
|
variations in the level of our operating expenses;
|
|
•
|
receipt, modification or termination of government contracts or grants, and the timing of payments we receive under these arrangements;
|
|
•
|
our execution of any collaborative, licensing or similar arrangements, and the timing of payments we may make under these arrangements; and
|
|
•
|
any intellectual property infringement lawsuit or opposition, interference or cancellation proceeding in which we may become involved.
|
|
•
|
a classified board of directors so that not all directors are elected at one time;
|
|
•
|
a prohibition on stockholder action through written consent;
|
|
•
|
no cumulative voting in the election of directors;
|
|
•
|
the exclusive right of our board of directors to elect a director to fill a vacancy created by the expansion of the board of directors or the resignation, death or removal of a director;
|
|
•
|
a requirement that special meetings of stockholders be called only by the board of directors, the chairman of the board of directors, the chief executive officer or, in the absence of a chief executive officer, the president;
|
|
•
|
an advance notice requirement for stockholder proposals and nominations;
|
|
•
|
the authority of our board of directors to issue preferred stock with such terms as the board of directors may determine; and a requirement of approval of not less than 66 2/3% of all outstanding shares of our capital stock entitled to vote to amend any bylaws by stockholder action, or to amend specific provisions of our certificate of incorporation.
|
|
|
|
|
|
Incorporated by Reference
|
|
|
||||
|
Exhibit Number
|
|
Description of Document
|
|
Form
|
|
Date
|
|
Number
|
|
Provided Herewith
|
|
2.1
|
|
Agreement and Plan of Merger and Reorganization, dated as of May 15, 2017, by and among Mirna Therapeutics, Inc., Meerkat Merger Sub, Inc. and Synlogic, Inc.
|
|
S-4/A
|
|
7/11/2017
|
|
2.1
|
|
|
|
2.2
|
|
Form of Support Agreement between Mirna Therapeutics, Inc. and certain stockholders of Synlogic, Inc.
|
|
S-4/A
|
|
7/11/2017
|
|
2.2
|
|
|
|
2.3
|
|
Form of Support Agreement between Synlogic, Inc. and certain stockholders of Mirna Therapeutics, Inc.
|
|
S-4/A
|
|
7/11/2017
|
|
2.3
|
|
|
|
2.4
|
|
Form of Lock-up Agreement, by and between Synlogic, Inc. and certain stockholders of Mirna Therapeutics, Inc.
|
|
S-4/A
|
|
7/11/2017
|
|
2.3
|
|
|
|
2.5
|
|
Form of Lock-up Agreement, by and between Mirna Therapeutics, Inc. and certain security holders of Mirna Therapeutics, Inc. and Synlogic, Inc.
|
|
S-4/A
|
|
7/11/2017
|
|
2.4
|
|
|
|
3.1
|
|
Amended and Restated Certificate of Incorporation.
|
|
8-K
|
|
10/6/2015
|
|
3.1
|
|
|
|
3.2
|
|
Amended and Restated Bylaws.
|
|
8-K
|
|
10/6/2015
|
|
3.2
|
|
|
|
4.1
|
|
Reference is made to Exhibits 3.1 through 3.2.
|
|
|
|
|
|
|
|
|
|
4.2
|
|
Form of Common Stock Certificate.
|
|
S-1/A
|
|
9/18/2015
|
|
4.2
|
|
|
|
10.1
|
|
Lease Termination Agreement and Release, dated as of May 5, 2017, between G&I VII Encino Trace II LP and Mirna Therapeutics, Inc.
|
|
S-4
|
|
6/21/2017
|
|
10.2(B)
|
|
|
|
10.2
|
|
Amendment to the Cancer Research Grant Contract, dated May 11, 2017, by and between Mirna Therapeutics, Inc. and the Cancer Prevention and Research Institute of Texas.
|
|
S-4
|
|
6/21/2017
|
|
10.3(B)
|
|
|
|
10.3
|
|
Amendment to the Cancer Research Grant Contract, dated May 11, 2017, by and between Mirna Therapeutics, Inc. and the Cancer Prevention and Research Institute of Texas.
|
|
S-4
|
|
6/21/2017
|
|
10.4(B)
|
|
|
|
10.4
|
|
Letter Agreement, dated May 11, 2017, by and between Mirna Therapeutics, Inc. and the Cancer Prevention and Research Institute of Texas.
|
|
S-4
|
|
6/21/2017
|
|
10.6
|
|
|
|
10.5#
|
|
Separation Agreement, effective as of May 19, 2017, by and between Vincent O’Neill, M.D. and Mirna Therapeutics, Inc.
|
|
8-K
|
|
5/25/2017
|
|
99.1
|
|
|
|
10.6#
|
|
Separation Agreement, effective as of July 7, 2017, by and between Casi DeYoung and Mirna Therapeutics, Inc.
|
|
S-4/A
|
|
7/11/2017
|
|
10.16(B)
|
|
|
|
31.1
|
|
Certification of Chief Executive Officer required by Rule 13a-14(a) or Rule 15d-14(a).
|
|
|
|
|
|
|
|
X
|
|
31.2
|
|
Certification of Chief Financial Officer required by Rule 13a-14(a) or Rule 15d-14(a).
|
|
|
|
|
|
|
|
X
|
|
32.1*
|
|
Certification required by Rule 13a-14(b) or Rule 15d-14(b) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350).
|
|
|
|
|
|
|
|
X
|
|
101.INS
|
|
XBRL Instance Document
|
|
|
|
|
|
|
|
X
|
|
101.SCH
|
|
XBRL Taxonomy Extension Schema Document
|
|
|
|
|
|
|
|
X
|
|
101.CAL
|
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
|
|
|
|
|
|
|
X
|
|
101.DEF
|
|
XBRL Taxonomy Extension Definition Linkbase Document
|
|
|
|
|
|
|
|
X
|
|
101.LAB
|
|
XBRL Taxonomy Extension Label Linkbase Document
|
|
|
|
|
|
|
|
X
|
|
101.PRE
|
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
|
|
|
|
|
|
|
X
|
|
|
MIRNA THERAPEUTICS, INC.
|
|
|
(Registrant)
|
|
|
|
|
Date: August 3, 2017
|
/s/ Paul Lammers
|
|
|
Paul Lammers, M.D., M.Sc.
Chief Executive Officer
(Principal Executive Officer)
|
|
|
|
|
Date: August 3, 2017
|
/s/ Alan Fuhrman
|
|
|
Alan Fuhrman
Chief Financial Officer
(Principal Financial & Accounting Officer)
|
No information found
* THE VALUE IS THE MARKET VALUE AS OF THE LAST DAY OF THE QUARTER FOR WHICH THE 13F WAS FILED.
| FUND | NUMBER OF SHARES | VALUE ($) | PUT OR CALL |
|---|
| DIRECTORS | AGE | BIO | OTHER DIRECTOR MEMBERSHIPS |
|---|
No information found
No Customers Found
No Suppliers Found
Price
Yield
| Owner | Position | Direct Shares | Indirect Shares |
|---|