Cocrystal Pharma, Inc. - Quarter Report: 2016 September (Form 10-Q)
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
☒
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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 September 30, 2016
OR
☐
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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
Commission file number: 000-55158
COCRYSTAL PHARMA, INC.
(Exact Name of Registrant as Specified in Its Charter)
Delaware
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35-2528215
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(State or Other Jurisdiction of Incorporation or
Organization)
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(I.R.S. Employer Identification No.)
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1860 Montreal Road
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Tucker, Georgia
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30084
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(Address of Principal Executive Offices)
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(Zip Code)
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(678)-892-8800
(Registrant’s Telephone Number, Including Area
Code)
Indicate
by check mark whether the registrant: (1) has
filed all reports required to be filed by Section 13 or
15(d) of the Securities Exchange Act of 1934 during the
preceding 12 months (or for such shorter period that the registrant
was required to file such reports), and (2) has been subject
to such filing requirements for the past 90 days. Yes☒
No☐
Indicate by check mark whether the registrant has
submitted electronically and posted on its corporate Web site, if
any, every Interactive Data File required to be submitted and
posted pursuant to Rule 405 of Regulation S-T (Sec.232.405 of
this chapter) during the preceding 12 months (or for such shorter
period that the registrant was required to submit and post such
files). Yes ☒ No
☐
Indicate
by check mark whether the registrant is a large accelerated filer,
an accelerated filer, a non-accelerated filer, or a smaller
reporting company. See the definitions of “large accelerated
filer,” “accelerated filer” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act.
(Check one):
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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☐
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Smaller reporting company
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☐
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(Do not check if a smaller reporting company)
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Indicate
by check mark whether the registrant is a shell company (as defined
in Rule 12b-2 of the Exchange Act). Yes ☐ No
☒
As of November 7, 2016, the number of outstanding shares of the
registrant’s common stock, par value $0.001 per share, was
714,031,508.
COCRYSTAL PHARMA, INC.
FORM 10-Q FOR THE QUARTER ENDED September 30,
2016
INDEX
F-1
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F-1
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F-1
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F-2
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F-3
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F-4
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F-5
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1
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||
5
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||
5
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7
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||
7
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8
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8
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9
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9
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9
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9
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10
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Part I – FINANCIAL INFORMATION
Cocrystal Pharma,
Inc.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
|
September 30,
2016
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December 31,
2015
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(unaudited)
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Assets
|
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Current
assets:
|
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Cash and cash equivalents
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$5,906
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$9,276
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Accounts receivable
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16
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32
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Prepaid expenses and other current
assets
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625
|
441
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Mortgage note receivable, current
portion
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208
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170
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Total
current assets
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6,755
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9,919
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Property
and equipment, net
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320
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430
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Deposits
|
54
|
31
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Mortgage
note receivable, long-term portion
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2,276
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2,354
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In
process research and development
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146,301
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146,301
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Goodwill
|
65,195
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65,195
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Total
assets
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$220,901
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$224,230
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|
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Liabilities
and stockholders' equity
|
|
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Current
liabilities:
|
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Accounts payable and accrued
expenses
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$1,243
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$2,585
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Derivative liabilities
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1,907
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4,115
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Total
current liabilities
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3,150
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6,700
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Long-term
liabilities
|
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Deferred rent
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54
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61
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Deferred tax liability
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49,875
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49,875
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Total
long-term liabilities
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49,929
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49,936
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Total
liabilities
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53,079
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56,636
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Commitments
and contingencies
|
|
|
|
|
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Series
A convertible preferred stock, $0.001 par value; 1,000 shares
authorized, 0 shares issued and outstanding at September 30, 2016
and December 31, 2015 respectively, issued in the merger with RFS
Pharma, LLC
|
-
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-
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|
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Stockholders'
equity:
|
|
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Series B convertible preferred stock, $.001 par
value; 5,000 shares authorized; 0 shares issued and outstanding at
September 30, 2016 and December 31, 2015, respectively
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-
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-
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Common stock, $.001 par value; 800,000 shares
authorized; 714,032 and 694,396 issued and outstanding as of
September 30, 2016 and December 31, 2015, respectively
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714
|
694
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Additional paid-in capital
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238,784
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229,456
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Accumulated deficit
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(71,676)
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(62,556)
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Total
stockholders' equity
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167,822
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167,594
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Total
liabilities and stockholders' equity
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$220,901
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$224,230
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Cocrystal Pharma, Inc.
CONDENSED CONSOLIDATED
STATEMENTS OF COMPREHENSIVE LOSS
(unaudited)
(in thousands)
|
Three months ended
September 30,
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Nine months ended
September 30,
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||
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2016
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2015
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2016
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2015
|
|
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Grant
revenues
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$-
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$24
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$-
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$78
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|
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Operating
expenses
|
|
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Research and development
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2,093
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2,177
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7,803
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5,751
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General and administrative
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(199)
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1,437
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3,630
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3,902
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Total
operating expenses
|
1,894
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3,614
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11,433
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9,653
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Loss
from operations
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(1,894)
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(3,590)
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(11,433)
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(9,575)
|
|
|
|
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Other
income (expense)
|
|
|
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Interest income
|
51
|
45
|
141
|
134
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Realized gain (loss) on marketable
securities
|
-
|
-
|
-
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(1,686)
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Other income (expense) net
|
-
|
1
|
(1)
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-
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Change in fair value of derivative
liabilities
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(38)
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3,036
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2,173
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(8,494)
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Total
other income (expense), net
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13
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3,082
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2,313
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(10,046)
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Loss
before income taxes
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(1,881)
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(508)
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(9,120)
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(19,621)
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Income
tax expense
|
-
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-
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-
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(52)
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Net
loss and comprehensive loss
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$(1,881)
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$(508)
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(9,120)
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$(19,673)
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Net
loss per common share:
|
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Income (loss) per share, basic
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$(0.00)
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$(0.00)
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$(0.01)
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$(0.03)
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Weighted average common shares outstanding,
basic
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707,478
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694,375
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702,634
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609,803
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Income (loss) per share, fully
diluted
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$(0.00)
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$(0.01)
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$(0.02)
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$(0.03)
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Weighted average common shares outstanding,
diluted
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707,478
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696,946
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703,417
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609,803
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Cocrystal Pharma,
Inc.
CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS' EQUITY
(unaudited)
(in thousands)
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Common
Stock
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Additional
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Accumulated
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Total Stockholders'
|
|
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Shares
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Amount
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Paid in
capital
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Deficit
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Equity
|
Balance
as of December 31, 2015
|
694,396
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$694
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$229,456
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$(62,556)
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$167,594
|
|
|
|
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Exercise
of warrants
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27
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-
|
35
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-
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35
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Exercise
of common stock options
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20
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-
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3
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-
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3
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Stock-based
compensation
|
-
|
-
|
297
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-
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297
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Sale
of common shares
|
19,589
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20
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8,993
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-
|
9,013
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Net
loss
|
-
|
-
|
-
|
(9,120)
|
(9,120)
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Balance
as of September 30, 2016
|
714,032
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$714
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$238,784
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$(71,676)
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$167,822
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Cocrystal Pharma, Inc.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
(in thousands)
|
Nine months ended
September 30,
|
|
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2016
|
2015
|
Operating
activities:
|
|
|
Net
loss
|
$(9,120)
|
$(19,673)
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Adjustments
to reconcile net loss to net cash used in operating
activities:
|
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Depreciation
|
159
|
133
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Deferred
income taxes
|
-
|
52
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Stock-based
compensation
|
297
|
2,049
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Change
in fair value of derivative liabilities
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(2,173)
|
8,494
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Realized
loss on marketable securities
|
-
|
1,686
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Change
in deferred rent
|
(7)
|
-
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Changes
in operating assets and liabilities:
|
|
|
Accounts
receivable
|
16
|
7
|
Prepaid expenses and
other current assets
|
(184)
|
(387)
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Accounts payable and accrued
expenses
|
(1,342)
|
362
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Net
cash used in operating activities
|
(12,354)
|
(7,277)
|
|
|
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Investing
activities
|
|
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Purchase
of fixed assets
|
(49)
|
(217)
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Long-term
deposits
|
(23)
|
-
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Principal
payments received on mortgage note receivable
|
40
|
55
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Net
cash provided by (used in) investing activities
|
(32)
|
(162)
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|
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Financing
activities
|
|
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Proceeds
from issuance of common stock and warrants
|
9,013
|
15,862
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Proceeds
from exercise of stock options
|
3
|
20
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Net
cash provided by financing activities
|
9,016
|
15,882
|
|
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Net
increase (decrease) in cash and cash equivalents
|
(3,370)
|
8,443
|
Cash
and cash equivalents at beginning of period
|
9,276
|
3,970
|
Cash
and cash equivalents at end of period
|
$5,906
|
$12,413
|
|
|
|
SUPPLEMENTAL DISCLOSURE OF NON-CASH INVESTING AND FINANCING
ACTIVITIES:
|
|
|
Unrealized
loss on marketable securities net of tax
|
$-
|
$(236)
|
Estimated
fair value of warrants exchanged for common shares
|
-
|
13,862
|
Cashless
exercise of warrants
|
35
|
-
|
Cocrystal Pharma,
Inc.
Notes to the Condensed Consolidated
Financial Statements
September 30, 2016
(unaudited)
Note 1- Organization and Significant Accounting
Policies
The Company
Cocrystal Pharma, Inc. (“the Company”) was formerly
incorporated in Nevada under the name Biozone Pharmaceuticals, Inc.
On January 2, 2014, Biozone Pharmaceuticals, Inc. sold
substantially all of its assets to MusclePharm Corporation
(“MusclePharm”), and, on the same day, merged with
Cocrystal Discovery, Inc. (“Discovery”) in a
transaction accounted for as a reverse merger. Following the
merger, the Company assumed Discovery’s business plan and
operations. On March 18, 2014, the Company reincorporated in
Delaware under the name Cocrystal Pharma, Inc.
Effective November 25, 2014, Cocrystal Pharma, Inc. and affiliated
entities completed a series of merger transactions as a result of
which Cocrystal Pharma, Inc. merged with RFS Pharma, LLC, a Georgia
limited liability company (“RFS Pharma”). We refer to
the surviving entity of this merger as “Cocrystal” or
the “Company.”
Cocrystal is a biotechnology company which develops novel
medicines for use in the treatment of human viral diseases.
Cocrystal has developed proprietary structure-based drug design
technology and antiviral nucleoside chemistry to create antiviral
drug candidates. Our focus is to pursue the development and
commercialization of broad-spectrum antiviral drug candidates
designed to transform the treatment and/or prophylaxis of hepatitis
C virus, influenza virus, norovirus, hepatitis B virus and human
papillomavirus. By concentrating our research and development
efforts on viral replication inhibitors, we plan to leverage our
infrastructure and expertise in these areas.
The Company operates in only one segment. Management uses cash flow
as the primary measure to manage its business and does not segment
its business for internal reporting or
decision-making.
The Company’s activities since inception have consisted
principally of acquiring product and technology rights, raising
capital, and performing research and development. Successful
completion of the Company’s development programs, obtaining
regulatory approvals of its products and, ultimately,
achieving profitable operations are dependent on, among other
things, its ability to access potential markets, securing
financing, attracting, retaining and motivating qualified
personnel, and developing strategic alliances. Through September
30, 2016, the Company has funded its operations
primarily through equity offerings.
As of September 30, 2016, the Company had an accumulated deficit of
$71.7 million. During the three and nine month periods ended
September 30, 2016, the Company had losses from operations of $1.9
million and $11.4 million, respectively. Cash used in operating
activities was approximately $12.4 million for the nine months
ended September 30, 2016. The Company has not yet established an
ongoing source of revenue sufficient to cover its operating costs.
The ability of the Company to continue as a going concern is
dependent on the Company obtaining adequate capital to fund
operating losses until it becomes profitable. The Company can give
no assurances that any additional capital that it is able to
obtain, if any, will be sufficient to meet its needs, or that any
such financing will be obtainable on acceptable terms. If the
Company is unable to obtain adequate capital, it could be forced to
cease operations or substantially curtail its drug development
activities. These conditions raise substantial doubt as to the
Company’s ability to continue as a going concern. The Company
expects to continue to incur substantial operating losses and
negative cash flows from operations over the next several years
during its pre-clinical and clinical development
phases.
Basis of Presentation and Significant Accounting
Policies
The accompanying unaudited condensed consolidated financial
statements have been prepared in accordance with U.S. generally
accepted accounting principles (“GAAP”) for interim
financial information and with the instructions to Form 10-Q and
Article 10 of Regulation S-X. Accordingly, they do not
include all of the information and footnotes required by U.S. GAAP
for complete financial statement presentation. In the
opinion of management, all adjustments (consisting of normal
recurring adjustments) considered necessary for a fair presentation
of the financial position, results of operations and cash flows for
the periods presented. Operating results for the nine
month period ended September 30, 2016 are not necessarily
indicative of the results that may be expected for the year ending
December 31, 2016 or any future interim periods. All intercompany
accounts and transactions have been eliminated in
consolidation.
These unaudited condensed financial statements should be read in
conjunction with the audited financial statements and footnotes
included in the Cocrystal Pharma, Inc. Annual Report on Form 10-K
for the year ended December 31, 2015 as filed with the U.S.
Securities and Exchange Commission (“SEC”). The
accompanying condensed consolidated balance sheet as of September
30, 2016 has been derived from the audited financial statements as
of that date, but does not include all of the information and notes
required by GAAP. The Company has evaluated subsequent
events after the balance sheet date of September 30, 2016 through
the date it has filed these unaudited condensed consolidated
financial statements with the SEC and has disclosed all events or
transactions that would require recognition or disclosures in these
unaudited condensed consolidated financial statements (See Note
11).
Our significant accounting policies and practices are presented in
Note 2 to the financial statements included in the Form
10-K.
Use of Estimates
The preparation of financial statements in conformity with GAAP
requires management to make estimates and assumptions that affect
the reported amounts of assets and liabilities and disclosure of
contingent assets and liabilities at the date of the financial
statements and the reported amounts of expenses during the
reporting period. Actual results could differ from those
estimates.
Recent Accounting Pronouncements
In August 2014, the Financial Accounting Standards Board
(“FASB”) issued Accounting Standards Update
(“ASU”) No. 2014-15, Disclosure of Uncertainties
about an Entity’s Ability to Continue as a Going
Concern (ASU 2014-15). ASU
2014-15 requires management to determine whether substantial doubt
exists regarding the entity’s going concern presumption,
which generally refers to an entity’s ability to meet its
obligations as they become due. If substantial doubt exists but is
not alleviated by management’s plan, the footnotes must
specifically state that “there is substantial doubt about the
entity’s ability to continue as a going concern within one
year after the financial statements are issued”. In addition,
if substantial doubt exists, regardless of whether such doubt was
alleviated, entities must disclose (a) principal conditions or
events that raise substantial doubt about the entity’s
ability to continue as a going concern (before consideration of
management’s plans, if any); (b) management’s
evaluation of the significance of those conditions or events in
relation to the entity’s ability to meet its obligations; and
(c) management’s plans that are intended to mitigate the
conditions or events that raise substantial doubt, or that did
alleviate substantial doubt, about the entity’s ability to
continue as a going concern. If substantial doubt has not been
alleviated, these disclosures should become more extensive in
subsequent reporting periods as additional information becomes
available. In the period that substantial doubt no longer exists
(before or after considering management’s plans), management
should disclose how the principal conditions and events that
originally gave rise to substantial doubt have been resolved. The
ASU applies prospectively to all entities for annual periods ending
after December 15, 2016, and to annual and interim periods
thereafter. Early adoption is permitted. The Company has not yet
adopted the provisions of this ASU.
In February 2016, the FASB issued ASU No. 2016-02,
Leases. The new standard establishes a
right-of-use (ROU) model that requires a lessee to record a ROU
asset and a lease liability on the balance sheet for all leases
with a term longer than 12 months. Leases will be
classified as either finance or operating, with classification
affecting the pattern of expense recognition in the income
statement. The Company is currently evaluating the
impact of its pending adoption of the new standard on its
consolidated financial statements.
In April 2016, the FASB issued ASU No. 2016-09, Stock Compensation
Topic 718: Improvements to Employee
Share-based Payment Accounting.
This ASU simplifies the accounting for stock compensation on income
tax accounting, classification of awards as either equity or
liabilities, estimating forfeitures, and cash flow
presentation. Based on this ASU, an entity should
recognize all excess tax benefits and tax deficiencies, including
tax benefits of dividends on share-based payment awards, as income
tax expense or benefit in the income statement; they do not need to
include the effects of windfalls and shortfalls in the annual
effective tax rate estimate from continuing operations used for
interim reporting purposes. As a result of including
income tax effects from windfalls and shortfalls in income tax
expense, the calculation of both basic and diluted EPS will be
affected. The ASU also provides an accounting policy
election for awards with service conditions to either estimate the
number of awards that are expected to vest (consistent with
existing U.S. GAAP) or account for forfeitures when they occur. The
ASU increases the allowable statutory tax withholding threshold to
qualify for equity classification from the minimum statutory
withholding requirements up to the maximum statutory tax rate in
the applicable jurisdiction(s). The ASU clarifies that cash paid to
a taxing authority by an employer when directly withholding
equivalent shares for tax withholding purposes should be considered
similar to a share repurchase, and thus classified as a financing
activity. All other employer withholding taxes on compensation
transactions and other events that enter into the determination of
net income continue to be presented within operating
activities. The new standard takes effect in 2017 for
public business entities and 2018 for all other entities. The
Company has not adopted the provisions of ASU No. 2016-09. The
Company is currently evaluating the impact of adopting ASU 2016-09
on its consolidated financial statements.
Note 2 – Fair Value Measurements
FASB Accounting Standards codification (“ASC”) 820
defines fair value, establishes a framework for measuring fair
value under generally accepted accounting principles and enhances
disclosures about fair value measurements. Fair value is defined
under ASC 820 as the exchange price that would be received for an
asset or paid to transfer a liability (an exit price) in the
principal or most advantageous market for the asset or liability in
an orderly transaction between market participants on the
measurement date. Valuation techniques used to measure fair value
under ASC 820 must maximize the use of observable inputs and
minimize the use of unobservable inputs. The standard describes a
fair value hierarchy based on three levels of inputs, of which the
first two are considered observable and the last unobservable, that
may be used to measure fair value which are the
following:
Level
1 — quoted prices in active markets for identical assets
or liabilities.
Level 2 —
other significant observable inputs for the assets or liabilities
through corroboration with market data at the measurement
date.
Level
3 — significant unobservable inputs that reflect
management’s best estimate of what market participants would
use to price the assets or liabilities at the measurement
date.
The Company categorized its cash equivalents as Level 1 fair value
measurements. The Company categorized its warrants
potentially settleable in cash as Level 3 fair value measurements.
The warrants potentially settleable in cash are measured at fair
value on a recurring basis and are being marked to fair value at
each reporting date until they are completely settled or meet the
requirements to be accounted for as component of
stockholders’ equity. The warrants are valued using the
Black-Scholes option-pricing model as discussed in Note 4
below.
The following table presents a summary of fair values of assets and
liabilities that are re-measured at fair value at each balance
sheet date as of September 30, 2016 and December 31, 2015, and
their placement within the fair value hierarchy as discussed above
(in thousands):
|
September
30,
|
Quoted
Prices in Active Markets
|
Significant
Other Observable Inputs
|
Unobservable
Inputs
|
Description
|
2016
|
(Level
1)
|
(Level
2)
|
(Level
3)
|
Assets:
|
|
|
|
|
Cash
and cash equivalents
|
$5,906
|
$5,906
|
$-
|
$-
|
Total
assets
|
$5,906
|
$5,906
|
$-
|
$-
|
|
|
|
|
|
Liabilities:
|
|
|
|
|
Warrants
potentially settleable in cash
|
$1,907
|
$-
|
$-
|
$1,907
|
Total
liabilities
|
$1,907
|
$-
|
$-
|
$1,907
|
|
December
31,
|
Quoted Prices in Active Markets
|
Significant Other
Observable
Inputs
|
Unobservable Inputs
|
Description
|
2015
|
(Level
1)
|
(Level
2)
|
(Level
3)
|
Assets:
|
|
|
|
|
Cash
and cash equivalents
|
$9,276
|
$9,276
|
$-
|
$-
|
Total
assets
|
$9,276
|
$9,276
|
$-
|
$-
|
|
|
|
|
|
Liabilities:
|
|
|
|
|
Warrants
potentially settleable in cash
|
$4,115
|
$-
|
$-
|
$4,115
|
Total
liabilities
|
$4,115
|
$-
|
$-
|
$4,115
|
The Company has not transferred any financial instruments into or
out of Level 3 classification during the nine months ended
September 30, 2016 or 2015. A reconciliation of the beginning and
ending Level 3 liabilities for the nine months ended September 30,
2016 and 2015 is as follows:
|
Fair
Value Measurements
Using
Significant Unobservable Inputs
(Level
3)
|
|
|
September
30, 2016
|
September
30, 2015
|
Balance
, January 1,
|
$4,115
|
$8,464
|
Estimated
fair value of warrants exchanged for common shares
|
(35)
|
(13,862)
|
Change
in fair value of warrants
|
(2,173)
|
8,494
|
Balance
at September 30, 2016 and 2015
|
$1,907
|
$3,096
|
Note 3
– Stockholders’ equity
Preferred Stock — The Company has authorized up to 5,000,000
shares of preferred stock, $0.001 par value per share, for
issuance. In connection with the Merger Agreement with Discovery,
the Company issued to Discovery’s security holders 1,000,000
shares of the Company’s Series B Convertible Preferred Stock
(“Series B”). The Series B shares automatically
converted into 205,083,086 shares of the Company’s common
stock on March 3, 2015 as a result of the Company’s
shareholders approving an increase in the number of the
Company’s authorized common shares to
800,000,000.
In connection with the merger with RFS Pharma in November 2014, the
Company created a new series of Series A Preferred Stock
(“Series A”). The Series A shares
automatically converted into 340,760,802 shares of the
Company’s common stock on March 3, 2015 as a result of the
Company’s shareholders approving an increase in the number of
the Company’s authorized common shares to
800,000,000.
Common Stock — The Company has authorized up to 800,000,000
shares of common stock, $0.001 par value per share, and had
714,031,508 shares issued and outstanding as of September 30,
2016.
On March 9, 2016, we accepted subscription agreements representing
investor commitments totaling $5,004,371 in a private placement
offering of 9,812,492 shares of our common stock at a purchase
price of $0.51 per share. The purchasers included seven members of
our board of directors including Dr. Raymond F. Schinazi and Dr.
Phil Frost. As of the date of this report, we have received all of
the committed funds.
On September 1, 2016, we closed on proceeds of $4,008,201 in a
private placement offering (the “Offering”) of
9,776,100 shares of our common stock at a purchase price of $0.41
per share. The purchasers included three members of our board of
directors, including Chairman Dr. Raymond F. Schinazi, Interim
Chief Executive Officer Dr. Gary Wilcox, and Dr. David Block. In
addition, OPKO Health, Inc., of which one of our director's Dr.
Phillip Frost is Chairman and Chief Executive Officer, invested in
the Offering.
Shares of common stock are reserved for future issuance as follows
as of September 30, 2016 (in thousands):
|
As of
September 30,
2016
|
|
|
Stock
options issued and outstanding
|
24,651
|
Options
reserved for future issuance under the Company's 2015 Incentive
Plan
|
47,885
|
Warrants
outstanding
|
6,275
|
Total
|
78,811
|
Note 4 – Warrants
The following is a summary of activity in the number of warrants
outstanding to purchase the Company’s common stock for the
nine months ended September 30, 2016 (in thousands):
|
Warrants accounted for as:
|
Warrants accounted for as:
|
|
|||||
|
Equity
|
|
Liabilities
|
|
||||
|
January
2012
warrants
|
March
2013
warrants
|
April
2013
warrants
|
|
February
2012
warrants
|
October
2013 Series A
warrants
|
January
2014
warrants
|
Total
|
|
|
|
|
|
|
|
|
|
Outstanding, December 31, 2015
|
650
|
455
|
1,500
|
|
1,000
|
775
|
4,000
|
8,380
|
|
|
|
|
|
|
|
|
|
Warrants
Expired
|
(650)
|
(455)
|
-
|
|
(889)
|
-
|
-
|
(1,994)
|
Warrants
exercised
|
-
|
-
|
-
|
|
(111)
|
-
|
-
|
(111)
|
|
|
|
|
|
|
|
|
|
Outstanding,
September 30, 2016
|
-
|
-
|
1,500
|
|
-
|
775
|
4,000
|
6,275
|
|
|
|
|
|
|
|
|
|
Expiration
date
|
January
11, 2016
|
March
1, 2016
|
April
25, 2018
|
|
February
28, 2016
|
October
24, 2023
|
January
16, 2024
|
|
|
Expired
|
Expired
|
|
|
Expired |
|
|
|
Warrants consist of warrants potentially settleable in cash, which
are liability-classified warrants, and equity-classified
warrants.
Warrants classified as liabilities
Liability-classified warrants consist of warrants issued in
connection with equity financings in February 2012, October 2013
and January 2014. The remaining warrants issued in
February 2012 expired during the first quarter of
2016. The remaining outstanding warrants issued in
October 2013 and January 2014 are potentially settleable in cash
and were determined not to be indexed to the Company’s own
stock and are therefore accounted for as liabilities.
The estimated fair value of outstanding warrants accounted for as
liabilities is determined at each balance sheet date. Any decrease
or increase in the estimated fair value of the warrant liability
since the most recent balance sheet date is recorded in the
consolidated statement of comprehensive loss as changes in fair
value of derivative liabilities. The fair value of the warrants
classified as liabilities is estimated using the Black-Scholes
option-pricing model with the following inputs as of September 30,
2016:
|
October
2013 warrants
|
January
2014 warrants
|
|
|
|
Strike
price
|
$0.50
|
$0.50
|
|
|
|
Expected
term (years)
|
7.1
|
7.3
|
Cumulative
volatility %
|
96%
|
97%
|
Risk-free
rate %
|
1.42%
|
1.44%
|
The Company’s expected volatility is based on a combination
of implied volatilities of similar publicly traded entities as well
as including the Company's own common stock volatility, given that
the Company has limited history of its own observable stock price.
The expected life assumption is based on the remaining contractual
terms of the warrants. The risk-free rate is based on the zero
coupon rates in effect at the balance sheet date. The dividend
yield used in the pricing model is zero, because the Company has no
present intention to pay cash dividends.
Warrants classified as equity
Warrants that were recorded in equity at fair value upon issuance,
and are not reported as liabilities on the balance sheet, are
included in the above table which shows all warrants.
Note 5 – Stock-based compensation
The Company reversed $1,392,000 of stock option expenses during the
third quarter of 2016 related to options that had been issued to
two executives that left the organization in July 2016 and which
had not vested. Stock option expenses recorded for the remaining
employees were $254,000, resulting in a negative stock option
expense of $1,138,000 for the three months ended September 30,
2016. For the nine months ended September 30, 2016 net stock option
expense was $299,000. For the three and nine months ended September
30, 2015, stock option expenses of $738,000 and $2,049,000 were
recognized, respectively. As of September 30, 2016, there was
$1,986,000 of unrecognized compensation cost related to outstanding
options that is expected to be recognized as a component of the
Company’s operating expenses over a weighted average period
of 2.4 years.
As of September 30, 2016, an aggregate of 72,536,000 shares of
common stock were reserved for issuance under the Company’s
Equity Incentive Plans, including 24,651,000 shares subject to
outstanding common stock options granted under the plan and
47,885,000 shares available for future grants. The administrator of
the plan determines the times when an option may become exercisable
at the time of grant. Vesting periods of options granted to date
have not exceeded five years. The options generally will
expire, unless previously exercised, no later than ten years from
the grant date. The Company is using unissued shares for all shares
issued for options and restricted share awards.
The following schedule presents activity in the Company’s
outstanding stock options for the nine months ended September 30,
2016 (in thousands, except per share amounts):
|
Number
of shares available for grant
|
Total
options outstanding
|
Weighted
Average Exercise Price
|
Aggregate
Intrinsic Value
|
Balance
at December 31, 2015
|
29,485
|
43,071
|
$0.48
|
$ 17,867
|
Exercised
|
-
|
(20)
|
0.15
|
-
|
Granted
|
-
|
-
|
-
|
-
|
Cancelled
|
18,400
|
(18,400)
|
|
|
Balance
at September 30, 2016
|
47,885
|
24,651
|
$0.31
|
$7,619
|
As of September 30, 2016, options to purchase 24,651,200 shares of
common stock, with an aggregate intrinsic value of $7,619,000, were
outstanding that were fully vested or expected to vest with a
weighted average remaining contractual term of 4.2 years. As of
September 30, 2016, options to purchase 21,598,860 shares of common
stock, with an intrinsic value of $6,342,000 were exercisable with
a weighted average exercise price of $0.17 per share and a weighted
average remaining contractual term of 3.7 years.
The aggregate intrinsic value of outstanding and exercisable
options at September 30, 2016 was calculated based on the closing
price of the Company’s common stock as reported on the OTCQB
market on September 30, 2016 of $0.49 per share less the exercise
price of the options. The aggregate intrinsic value is calculated
based on the positive difference between the closing fair market
value of the Company’s common stock and the exercise price of
the underlying options.
Note 6 – Net Loss per Share
The Company accounts for and discloses net loss per common share in
accordance with FASB ASC Topic 260, Earnings Per
Share. Basic net loss per
common share is computed by dividing net loss attributable to
common stockholders by the weighted average number of common shares
outstanding (which includes the common share equivalents of the
outstanding Series B preferred shares prior to their conversion to
common stock in March 2015). Diluted net loss per common share is
computed by dividing net loss attributable to common stockholders
by the weighted average number of common shares that would have
been outstanding during the period assuming the issuance of common
shares for all potential dilutive common shares outstanding.
Potential common shares consist of shares issuable upon the
exercise of stock options and warrants.
The following table sets forth the computation of basic and diluted
net loss per share (amounts in thousands, except per share
amounts):
|
Three
months ended
September
30,
|
Nine
months ended
September
30,
|
||
|
2016
|
2015
|
2016
|
2015
|
Numerator:
|
|
|
|
|
Net
income (loss)
|
$(1,881)
|
$(508)
|
$(9,120)
|
$(19,673)
|
Change
in fair value of derivative liability - income/(loss)
|
-
|
3,036
|
2,173
|
-
|
Net
income (loss) attributable to shareholders
|
$(1,881)
|
$(3,544)
|
$(11,293)
|
$(19,673)
|
|
|
|
|
|
Denominator:
|
|
|
|
|
Weighted average shares outstanding used to compute net
income (loss) per share:
|
|
|||
Basic
|
707,478
|
694,375
|
702,634
|
609,803
|
Adjustment
for dilutive effects of warrants
|
-
|
2,571
|
783
|
-
|
Diluted
|
707,478
|
696,946
|
703,417
|
609,803
|
|
|
|
|
|
Net
income (loss) per share
|
|
|
|
|
Basic
(net income / basic shares)
|
$(0.00)
|
$(0.00)
|
$(0.01)
|
$(0.03)
|
Diluted
(net income attributable/ diluted shares)
|
$(0.00)
|
$(0.01)
|
$(0.02)
|
$(0.03)
|
The following table sets forth the number of potential common
shares excluded from the calculations of net loss per diluted share
because their inclusion would be anti-dilutive (in
thousands):
|
For
the three months ended
September
30,
|
For
the nine months ended
September
30,
|
||
|
2016
|
2015
|
2016
|
2015
|
Options
to purchase common stock
|
24,651
|
24,614
|
24,651
|
24,614
|
Warrants
to purchase common stock
|
-
|
2,571
|
783
|
-
|
Total
|
24,651
|
27,185
|
25,434
|
24,614
|
Note 7 - Mortgage Note Receivable
In June 2014, the Company acquired a mortgage note from a bank for
$2,626,290 which is collateralized by, among other things, the
underlying real estate and related improvements. The property
subject to the mortgage is owned by 580 Garcia Properties, an
entity managed by Daniel Fisher, one of the founders of Biozone,
and is currently under lease to MusclePharm Corporation
(“MusclePharm”). At September 30, 2016, the carrying
amount of the mortgage note receivable was $2,507,000. The mortgage
note has a maturity date of August 1, 2032 and bears an interest
rate of 7.24%. The Company records its mortgage note receivable at
the amount advanced to the borrower, which includes the stated
principal amount and certain loan origination and commitment fees
that are recognized over the term of the mortgage note. Interest
income is accrued as earned over the term of the mortgage note. The
Company evaluates the collectability of both interest and principal
of the note to determine whether it is impaired. The note would be
considered to be impaired if, based on current information and
events, the Company determined that it was probable that it would
be unable to collect all amounts due according to the existing
contractual terms. If the note were considered to be impaired, the
amount of loss would be calculated by comparing the recorded
investment to the value determined by discounting the expected
future cash flows at the note’s effective interest rate or to
the fair value of the Company’s interest in the underlying
collateral, less the cost to sell. No impairment loss has been
recognized in connection with the mortgage note
receivable.
On December 23, 2015, the Company issued notice of default letters
to 580 Garcia Properties, Daniel Fisher and Sharon Fisher for
failure to remit certain payments on the promissory note. The
Company also exercised a failure to pay provision within that note
to escalate the interest rate from 7.24% to 11.24%. On
September 27, 2016, The Notice of Default and Election to Sell
under Deed of Trust was formally filed and recorded in Contra Costa
County California. As of September 8, 2016, the additional amounts
due the Company total approximately $206,000. Due to the contingent
nature of this default action, the Company has not recorded a
receivable for this amount in its financial statements. The
Company is no longer accepting scheduled payments from the
defendants until matter is resolved.
Note 8
– Income Taxes
Deferred income tax assets and liabilities are recognized for the
estimated future tax consequences attributable to differences
between the financial reporting and tax bases of assets and
liabilities and are measured using enacted tax rates in effect for
the year in which those temporary differences are expected to be
recovered or settled. A valuation allowance is provided for the
amount of deferred tax assets that, based on available evidence,
are not expected to be realized.
As a result of the Company’s cumulative losses, management
has concluded that a full valuation allowance against the
Company’s net deferred tax assets is appropriate. The Company
has recorded a net deferred tax liability of $49,875,000 as of
September 30, 2016 and December 31, 2015 as it has not considered
the deferred tax liability, which is related to acquired in-process
research and development, to be a future source of taxable income
in evaluating the need for a valuation allowance against its
deferred tax assets due to the in-process research and development
asset being considered an indefinite-lived intangible
asset.
FASB ASC Topic 740, Income
Taxes (“ASC 740”), prescribes a recognition
threshold and a measurement criterion for the financial statement
recognition and measurement of tax positions taken or expected to
be taken in a tax return. For those benefits to be recognized, a
tax position must be considered more likely than not to be
sustained upon examination by taxing authorities. The Company
records interest and penalties related to uncertain tax positions
as a component of the provision for income taxes. As of September
30, 2016 and December 31, 2015, the Company had no unrecognized tax
benefits.
The Company currently files income tax returns in the United States
federal and various state jurisdictions. The Company is not
currently under examination in any jurisdiction.
Note 9 - Contingencies
From time to time, the Company is a party to, or otherwise involved
in, legal proceedings arising in the normal course of
business. As of the date of this report, except as
described below, the Company is not aware of any proceedings,
threatened or pending, against it which, if determined adversely,
would have a material effect on its business, results of
operations, cash flows or financial position.
The Company has been named as a party to a lawsuit filed on April
15, 2014 in Contra Costa County, California by an entity managed by
Mr. Daniel Fisher. Also named in this action are two of the
Company’s subsidiaries – BioZone Laboratories and
Cocrystal Discovery. The action seeks recovery on a
promissory note purportedly executed by BioZone Laboratories in the
principal amount of $295,000 in 2007, or almost seven years before
the Company’s acquisition of Cocrystal Discovery.
Motions challenging the sufficiency of the allegations in the
complaint were filed in the third quarter, 2014. The motions were
granted and plaintiff was given an opportunity to amend the
complaint, and plaintiff has filed an amended complaint. On July 2,
2015 the Company, along with its subsidiaries and other named
defendants, filed a motion to bifurcate the action, and stay
discovery on one of the causes of action. This motion was
granted on August 27, 2015 and the Court limited the scope of
discovery in the first phase of the case. The Court also
ordered that the Company post a bond for the amount of $295,000,
and the Company complied with the Order by posting the bond on
September 29, 2015. This is recorded as a short-term deposit.
At a hearing held April 19, 2016 the Court ordered the
parties to attempt resolution through a mediation. This
mediation took place May 19, 2016 with no resolution. A trial date
has been set for February 2017.
On October 13, 2013, Plaintiff Shefa LMV, LLC ("Plaintiff") filed a
First Amended Complaint in Los Angeles Superior Court for civil
penalties and injunctive relief against numerous retailers and
manufacturers of products, and alleged violations of California
Health & Safety Code Sec. 25249.6 (part of the "Safe Drinking
Water and Toxic Enforcement Act") and California Business &
Professional Code Sec. 17200, et seq. (California's "Unfair
Competition Law"). The case is captioned Shefa LMV, LLC
v. Walgreens Co., et al., LASC Case No. BC520416. The
complaint alleges that the retailers and manufacturers failed to
place a clear and reasonable warning on the products which
contained "Cocamide DEA" pursuant to the Safe Drinking Water and
Toxic Enforcement Act, and further requested that the defendants be
enjoined from manufacturing or selling products with Cocamide DEA
in the State of California. Numerous actions that had
been filed alleging similar claims against defendants who
manufactured and/or sold Cocamide DEA products have been
coordinated, with a new Judicial Council Coordination Proceeding
Case No. JCCP 4765. On October 17, 2014, Plaintiff filed
an amendment to the Complaint, adding BioZone Laboratories, Inc. a
California corporation, as Doe Defendant No. 9. The
Company filed an Answer to the First Amended Complaint on October
13, 2015. No discovery has taken place yet.
In October 2015, Cocrystal Pharma, Inc. received a subpoena from
the staff of the Securities and Exchange Commission seeking the
production of documents. The Company is fully cooperating
with the inquiry. The Company cannot predict or determine
whether any proceeding may be instituted in connection with the
subpoena or the outcome of any proceeding that may be
instituted.
On December 23, 2015, the Company issued notice of default letters
to 580 Garcia Properties, Daniel Fisher and Sharon Fisher for
failure to remit certain payments on a promissory note executed
between the parties in June 2014. On September 27, 2016, The
Notice of Default and Election to Sell under Deed of Trust was
formally filed and recorded in Contra Costa County California. The
additional amounts due the Company have not been recorded in its
financial statements.
Note 10 - Transactions with Related Parties
As part of the merger (that occurred on November 25, 2014) with RFS
Pharma, LLC, Cocrystal assumed the lease for RFS Pharma facilities
located in Tucker, Georgia. This lease was amended on January
1, 2014 and expires on December 31, 2016 for approximately 5,626
square feet of office and laboratory space. Cocrystal leases the
Tucker, Georgia facility from a trust established, in part, for the
benefit of one of Cocrystal’s Directors, Dr. Raymond
Schinazi. This lease terminates
December 31, 2016. The total rent expense was $59,000
and $177,000 for the three and nine months ended September 30,
2016, respectively, and $55,000 and $165,000 for the three and nine
months ended September 30, 2015, respectively.
Emory University: Cocrystal Pharma has an exclusive license from
Emory University for use of certain inventions and technology
related to inhibitors of HCV that were jointly developed by Emory
and Cocrystal Pharma employees. The License Agreement is dated
March 7, 2013 wherein Emory agrees to add to the Licensed Patents
and Licensed Technology Emory’s rights to any patent, patent
application, invention, or technology application that is based on
technology disclosed within three (3) years of March 7, 2013. The
agreement includes payments due to Emory ranging from $40,000 to
$500,000 based on successful achievement of certain drug
development milestones. Additionally, Cocrystal may have royalty
payments at 3.5% of net sales due to Emory with a minimum in year
one of $25,000 and increase to $400,000 in year five upon product
commercialization. One of Cocrystal’s Directors, Dr. Raymond
Schinazi, is also a faculty member at Emory University and may
share in these royalty payments to Emory.
Duke University and Emory University: Cocrystal Pharma has entered
an agreement to license various patents and know-how to use
CRISPR/Cas9 technologies for developing a possible cure for
hepatitis B virus (HBV) and human papilloma virus (HPV). This
license allows Cocrystal Pharma to develop and potentially
commercialize a cure for HBV and HPV utilizing the underlying
patents and technologies developed by the universities. This
agreement includes a non-refundable $100,000 license fee payable to
Duke upon a determination of rights letter from the U.S. Veterans
Administration with respect to patents and know-how that disclaims
any ownership interest. Future royalties may be payable to Duke,
ranging from 2-5% of net sales depending on achieving certain sales
milestones, if commercial products are developed using this
know-how. One of Cocrystal’s Directors, Dr. Raymond Schinazi,
is also a faculty member at Emory University and may share in these
royalty payments to Emory.
We have engaged seven physicians that comprise our Scientific
Advisory Board. These physicians are compensated
approximately $25,000 per quarter collectively for providing their
expertise. Three of these physicians are also investors in
our company.
Note 11 – Subsequent Events
ITEM 2. MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
Overview
Cocrystal is a biotechnology company working to
develop novel medicines for use in the treatment of human
viral diseases. Cocrystal has developed proprietary structure-based
drug design technology and antiviral nucleoside chemistry to create
first-in-class and best-in-class antiviral drug
candidates. Our focus is to pursue the development and
commercialization of broad-spectrum antiviral drug candidates that
will transform the treatment and/or prophylaxis of hepatitis C
virus, norovirus, and influenza virus. By concentrating our
research and development efforts on viral replication inhibitors,
we plan to leverage our infrastructure and expertise in these
areas.
Highlights
During the three months ending September 30, 2016, the Company
focused on its research and development efforts and continued its
clinical trials for our Non-Nucleoside HCV Polymerase Inhibitor
(NNI) CC-31244, which began in April 2016.
●
Hepatitis C - CC-31244 (Pan-genotypic
NNI). The Company
announced positive interim data from a randomized, double-blind
Phase Ia/Ib study of CC-31244, a pan-genotypic, potent NS5B
non-nucleoside inhibitor (NNI), for the treatment of chronic
hepatitis C virus (HCV) infection. The study is designed to
evaluate CC-31244's safety/tolerability and pharmacokinetics,
including food effect and antiviral activity.
The study includes
two groups: Group A (single ascending doses, and multiple doses in
healthy volunteers), and Group B (multiple doses in HCV infected
individuals). The study has dosed a total of 42 healthy volunteers
with single (20, 50, 100, 200 and 400 mg) and multiple doses of
CC-31244 at 200 and 400 mg for 7 days. Four HCV GT1 infected
patients have been dosed with 400 mg once daily for 7 days.
Initial data from
the once daily 400 mg dosing study show that CC-31244 had a
substantial and durable antiviral effect with an average HCV RNA
viral load decline from baseline of 3 logs by Day 4. The average
viral load did not return to baseline levels even at 6 days post
last dose. In addition, no viral breakthrough was observed during
the treatment period. No serious adverse event was reported. To
date, CC-31244 appears to be safe and well tolerated in both
healthy and HCV-infected subjects.
●
Hepatitis C – CC-2850 (Pan-genotypic
nucleoside inhibitor). We have generated additional
pre-clinical in
vitro and in vivo data for comparison with
Sofosbuvir.
●
Hepatitis C – CC-2069 (Pan-genotypic NS5A
inhibitor). We have obtained additional
preclinical in vitro data for CC-2069. We are nearing completion of the
synthesis of non-GMP and GMP batches of
CC-2069.
●
Hepatitis C -
Helicase – We have continued preclinical studies on several
helicase inhibitors and have conducted in vitro combination studies with HCV
DAAs (Direct-Acting Antivirals).
●
Influenza - We are developing novel broad spectrum
inhibitors of the influenza A polymerase enzyme. Our inhibitors
target an enzyme complex essential to influenza viral replication
and transcription, and have shown excellent in vitro potency and pharmacokinetic properties. Our lead
molecule is now being tested in pre-clinical toxicology
studies.
●
Norovirus - We have
continued to identify and test nucleoside and non-nucleoside
polymerase inhibitors.
Results of Operations for the Three and Nine months Ended September
30, 2016 compared to the Three and Nine months Ended September 30,
2015
Revenue
As previously stated, we are focused on research and development of
novel medicines for use in the treatment of human viral diseases.
We had no revenue for the three and nine months ended September 30,
2016. Grant revenues received during the three and nine
months ended September 30, 2015 were $24,000 and $78,000,
respectively, and were related to a collaboration with the
University of Mississippi on an R01 grant from the National Center
of Complementary and Alternative Medicine.
Research and Development Expense
Research and development expense consists primarily of
compensation-related costs for our employees dedicated to research
and development activities and for our Scientific Advisory Board
members, as well as lab supplies, lab services, and facilities and
equipment costs. We expect research and development expenses to
increase in future periods as we expand our clinical and
pre-clinical development activities.
Total research and development expenses were approximately
$2,093,000 for the three months ended September 30, 2016, compared
with $2,177,000 for the three months ended September 30, 2015. The
decrease of $84,000, or 4%, was due a decrease in stock-based
compensation expense of $352,000 caused primarily by reversal of
stock-based compensation expense associated with options that were
forfeited by an employee prior to vesting, and lower operating
costs of $119,000 (primarily a decrease in rent expense of
$98,000), offset by higher clinical and pre-clinical costs, a
$395,000 increase, as we proceeded with a Phase I clinical trial in
2016.
Total research and development expenses were approximately
$7,803,000 for the nine months ended September 30, 2016, compared
with $5,751,000 for the nine months ended September 30, 2015. The
increase of $2,052,000 or 36%, was due to a $1,619,000 increase in
pre-clinical and clinical costs as we ramped up a phase I trial in
2016, a $200,000 increase in professional fees for consulting
services engaged to support initiation of a Phase I clinical trial,
and $109,000 in compensation and other operating costs. These were
partially offset by a reduction in general operating costs of
$193,000 (primarily a decrease in rent expense of
$153,000).
General and Administrative Expense
General and administrative expense includes compensation-related
costs for our employees dedicated to general and administrative
activities, legal fees, audit and tax fees, consultants and
professional services, and general corporate expenses.
General and administrative expenses were negative for the three
months ended September 30, 2016 in the amount of $199,000, compared
with positive expense of $1,437,000 for the three months ended
September 30, 2015. The decrease of $1,636,000, is due to a
$1,524,000 decline in stock-based compensation expense, lower
personnel costs of $244,000 and lower travel and entertainment
expenses of $41,000, offset by higher general operating costs of
$183,000 (primarily an increase in rent expense of $98,000).
The significant decline in stock-based compensation and the
resulting negative amount of general and administrative expense for
the three months ended September 30, 2016 was due to reversal of
stock-based compensation expense associated with options that were
forfeited by the Company's former Chief Executive Officer prior to
vesting. Because we had assumed a zero forfeiture rate
related to these options, expense associated with these options
that had been recorded in previous periods was reversed during the
three months ended September 30, 2016, since none of these options
had vested prior to forfeiture.
General and administrative expenses were approximately $3,630,000
for the nine months ended September 30, 2016, compared with
$3,902,000 for the nine months ended September 30, 2015. The
decrease of $272,000, or 7%, is due to a $1,616,000 decline in
stock option expense, primarily for the reason cited in the
previous paragraph, offset by higher personnel costs of $321,000,
higher professional fees of $569,000 (primarily legal expenses) and
higher general operating costs of $451,000 (reflecting higher rent
of $221,000, higher depreciation related to equipment additions and
leasehold improvements at our Tucker, Georgia facility of $70,000,
higher insurance costs related to D&O coverage and the addition
of clinical trials coverage of $47,000, higher utilities and
network services of $70,000 and California franchise taxes of
$30,000 related to an audit of one of our predecessor companies,
Biozone Pharmaceuticals).
Interest Income/Expense
Interest income was $51,000 and $141,000 for the three months and
nine months ended September 30, 2016, respectively. Interest income
was $45,000 and $134,000 for the three months and nine months ended
September 30, 2015, respectively. These amounts represents interest
earned on the mortgage note we acquired in June
2014. Interest expense was negligible for the three and
nine months ended September 30, 2016 and 2015.
Other Income/Expense
Other income, net was $13,000 and $2,313,000 for the three and nine
months ended September 30, 2016, respectively. Other
income consists primarily of the change in fair value of
outstanding warrants to purchase our common stock, which are
accounted for as liabilities. For both the three and nine months
ended September 30, 2016 our stock price decreased, 111,111
warrants were exercised and 888,889 warrants expired. Under
accounting principles generally accepted in the United
States, we record other income or expense for the change in
fair value of our outstanding warrants that are accounted for as
liabilities during each reporting period. If the fair
value of the warrants decreases during the period, we record other
income. The fair value of our outstanding warrants is
inversely related to the fair value of the underlying common stock;
as such, a decrease in the fair value of our common stock during a
given period generally results in other income while an increase in
the fair value of our common stock results in other expense.
For the three and nine months ended September 30, 2015, we recorded
other income of $3,082,000 and other expense of $10,046,000,
respectively. Except for the interest income amount
noted above, this other income or expense is non-cash. We
believe investors should focus on our operating loss rather than
net loss for the periods presented. Our operating loss
for the three and nine months ended September 30, 2016 was
$1,894,000 and $11,433,000, respectively, compared to $3,590,000
and $9,575,000 for the same periods in 2015,
respectively.
Income Taxes
As a result of our cumulative losses, we have concluded that a full
valuation allowance against our net deferred tax assets is
appropriate. We have recorded a net deferred tax liability of
$49,875,000 as of September 30, 2016 and December 31, 2015 as we
have not considered the deferred tax liability, which is related to
acquired in-process research and development, to be a future
source of
taxable income in evaluating the need for a valuation allowance
against our deferred tax assets due to the in-process research and
development asset being considered an indefinite-lived intangible
asset.
Net Loss
As a result of the above factors, for the three and nine months
ended September 30, 2016, we had a net loss of approximately
$1,881,000 and $9,120,000 compared to a net loss of approximately
$508,000 and $19,673,000 for the same periods in
2015. For the three months ended September 30, 2016, our
net loss increased $1,373,000 compared to the same period in 2015
primarily from lower other income recognized on the change in fair
value of our warrant liability ($3,074,000 other income reduction)
offset by lower stock option expenses of $1,856,000 due to the
aforementioned options forfeiture by two executives that left the
organization. Greater research and development pre-clinical and
clinical spending for the three months ended September 30, 2016
compared to the same period last year ($395,000 increase)
contributes to the overall increase in net loss for the period. The
decrease in net loss for the nine months ended September 30, 2016
as compared to the nine months ended September 30, 2015 of
$10,553,000 is primarily attributable to the $10.7 million
difference in the amount recorded during the periods related to the
change in the fair value of our warrant liabilities, as described
above, offset by increases in research and development pre-clinical
and clinical spending as we ramped up a phase I trial in
2016. We believe investors should focus on our operating
loss rather than net loss for the periods presented. Our
operating loss, which does not include the change in the value of
derivative liabilities, a non-cash expense, for the three and nine
months ended September 30, 2016 was $1,894,000 and $11,433,000
respectively, compared to an operating loss $3,590,000 and
$9,575,000 for the same periods in 2015,
respectively.
Liquidity and Capital Resources
Net cash used in operating activities was approximately
$12,354,000 for the nine months ended September 30, 2016
compared to $7,277,000 for the same period in 2015. For the nine
months ended September 30, 2016, net cash used by operating
activities consisted primarily of $11,433,000 in operating expenses
net of changes in operating assets and liabilities.
Net cash used in investing activities was $32,000 for the nine
months ended September 30, 2016 compared to $162,000 provided for
the same period in 2015. For the nine months ended
September 30, 2016, net cash used for investing activities
consisted primarily of capital spending of $49,000 and long-term
deposits of $23,000, net of $40,000 in principal payments received
on our mortgage note receivable. For the nine months ended
September 30, 2015, net cash used for investing activities of
$162,000 consisted of capital spending of $217,000, mostly for
renovations of our Tucker, Georgia facility, net of principal
payments received on our mortgage note receivable of
$55,000.
Net cash provided by financing activities was approximately
$9,016,000 for the nine months ended September 30, 2016 compared to
cash provided by financing activities of $15,882,000 for the same
period in 2015. Net cash provided by financing activities for the
nine months ended September 30, 2016 amounted to approximately
$9,013,000 in proceeds from sale of our common stock and $3,000 for
the exercise of stock options. For the nine months ended
September 30, 2015, cash provided by financing activities resulted
from our sale of common stock and warrants, which resulted in
proceeds of $15,862,000, and proceeds from the exercise of stock
options of $20,000.
We have a history of operating losses as we have focused our
efforts on raising capital and research and development activities.
The Company’s consolidated financial statements are prepared
using generally accepted accounting principles in the United States
of America applicable to a going concern, which contemplates the
realization of assets and the satisfaction of liabilities in the
normal course of business. The Company has never been profitable,
has no products approved for sale, has not generated any revenues
to date from product sales, and has incurred significant operating
losses and negative operating cash flows since inception. For the
year ended December 31, 2015, the Company recorded a net loss of
approximately $50.1 million and used approximately $10.3 million of
cash in operating activities. For the nine months ended September
30, 2016, the Company recorded a net loss of approximately $9.1
million and used approximately $12.4 million of cash for operating
activities.
As of September 30, 2016
and November 7, 2016, the Company has $5.9 million
and $5.2 million, respectively, in cash to
fund its operations. The
Company does not believe its current cash balances will
be sufficient to allow the Company to fund its operating plan
for the next twelve months. The ability of the Company to
continue as a going concern is dependent on the Company obtaining
adequate capital to fund operating losses until it becomes
profitable. If the Company is unable to obtain adequate capital, it
could be forced to cease operations or substantially curtail its
drug development activities. These conditions raise substantial
doubt as to the Company’s ability to continue as a going
concern. The accompanying financial statements do not include
any adjustments relating to the recoverability and classification
of recorded asset amounts and classification of liabilities should
the Company be unable to continue as a going
concern.
As the Company continues to incur losses, achieving profitability
is dependent upon the successful development, approval and
commercialization
of its product candidates, and achieving a level of revenues
adequate to support the Company’s cost structure. The Company
may never achieve profitability, and unless and until it does, the
Company will continue to need to raise additional capital.
Management intends to fund future operations through additional
private or public equity offering and may seek additional
capital through arrangements with strategic partners or from other
sources. There can be no assurances, however, that additional
funding will be available on terms acceptable to the Company, or at
all. Any equity financing may be dilutive to existing
shareholders.
Tabular Disclosure of Contractual Obligations
Contractual
Obligations ($ in thousands)
|
Payments
due by period
|
|||
|
Less
than
1
year
|
1-3
years
|
3-5
years
|
More
than 5 years
|
Operating
Lease Obligations
|
$191
|
$333
|
$-
|
$-
|
The
above amounts exclude potential payments to be made under our
license agreement to our licensors that are based on the progress
of our product candidates in development, as these payments are not
determinable.
Cocrystal Pharma has an exclusive license from Emory University for
use of certain inventions and technology related to inhibitors of
HCV that were jointly developed by Emory and Cocrystal Pharma
employees. The agreement includes payments due to Emory ranging
from $40,000 to $500,000 based on successful achievement of certain
drug development milestones. Additionally, Cocrystal may have
royalty payments at 3.5% of net sales due to Emory with a minimum
in year one of $25,000 and increase to $400,000 in year five upon
product commercialization.
Cocrystal Pharma has entered an agreement to license various
patents and know-how to use CRISPR/Cas9 technologies for developing
a possible cure for hepatitis B virus (HBV) and human papilloma
virus (HPV) from Duke and Emory Universities. This agreement
includes a non-refundable $100,000 license fee payable to Duke upon
a determination of rights letter from the U.S. Veterans
Administration with respect to patents and know-how that disclaims
any ownership interest. Future royalties may be payable to Duke,
ranging from 2-5% of net sales depending on achieving certain sales
milestones, if commercial products are developed using this
know-how.
Cautionary Note Regarding Forward-Looking Statements
This report includes forward-looking statements including
statements regarding our drug development activities, future equity
offering, cash flow deficit and liquidity. The
words “believe,” “may,”
“estimate,” “continue,”
“anticipate,” “intend,”
“should,” “plan,” “could,”
“target,” “potential,” “is
likely,” “will,” “expect” and similar
expressions, as they relate to us, are intended to identify
forward-looking statements. We have based these
forward-looking statements largely on our current expectations and
projections about future events and financial trends that we
believe may affect our financial condition, results of operations,
business strategy and financial needs.
The results anticipated by any or all of these forward-looking
statements might not occur. Important factors that could cause
actual results to differ from those in the forward-looking
statements include the continued strength of the market for bio
pharma equity offerings, unanticipated events which adversely
affect the timing and success of our regulatory filings, failure to
develop products which are deemed safe and effective and other
issues which affect our ability to commercialize our product
candidates. Further information on our risk factors is
contained in our filings with the SEC, including our Annual Report
on Form 10-K. We undertake no obligation to publicly update or
revise any forward-looking statements, whether as the result of new
information, future events or otherwise.
Critical Accounting Policies and Estimates
In our Annual Report on Form 10-K for the year
ended December 31, 2015, we disclosed our critical accounting
policies and estimates upon which our financial statements are
derived. There have been no changes to these policies since
December 31, 2015. Readers are encouraged to review these
disclosures in conjunction with the review of this report. Because
of the materiality associated with in-process research and
development assets on our Balance Sheet, the following has been
included which highlights management’s assessment of
impairment of these assets.
Business Combinations and Intangible
Assets
In
connection with our acquisition of RFS Pharma in November 2014, we
acquired a substantial amount of intellectual
property. We have accounted for the intellectual
property acquired as an in-process research and development
(IPR&D) asset and have determined that asset to have an
indefinite life based on the stage of development of the research
projects of RFS Pharma at the date of acquisition. This
intangible asset, which is presently recorded at $146.3 million,
will continue to have an indefinite life until the associated
research and development activities are complete, at which point a
determination of the asset’s useful life will be
made. Prior to completion of these research and
development activities, the intangible asset will be subject to
annual impairment tests, or more frequent tests in the event of any
impairment indicators occurring. These impairment tests
require significant judgment regarding the status of the research
activities, the potential for future revenues to be derived from
any products that may result from those activities, and other
factors. The Company’s annual impairment test is done as of
November 30, 2016 to coincide with the acquisition date of RFS
Pharma. Management has concluded during the interim period covered
by our third quarter 10-Q report that no impairment indicators have
occurred.
ITEM 3. QUANTITATIVE AND QUALITATIVE
DISCLOSURES ABOUT MARKET RISK.
There has been no material change in our assessment of sensitivity
to market risk since our presentation set forth in Item 7A
“Quantitative and Qualitative Disclosures about Market
Risk” in our Annual Report on Form 10-K for the fiscal year
ended December 31, 2015.
ITEM 4. CONTROLS AND
PROCEDURES
Our management is responsible for establishing and maintaining
adequate internal control over financial reporting as defined in
Rules 13a-15(f) and 15d-15(f) under the Securities Exchange Act.
Our management is also required to assess and report on the
effectiveness of our internal control over financial reporting in
accordance with Section 404 of the Sarbanes-Oxley Act of 2002
(“Section 404”). Management assessed the effectiveness
of our internal control over financial reporting as of September
30, 2016. In making this assessment, we used the criteria set forth
by the Committee of Sponsoring Organizations of the Treadway
Commission (COSO) in Internal Control - Integrated
Framework (2013). During our
assessment of the effectiveness of internal control over financial
reporting as of September 30, 2016, we identified the
following material weaknesses:
COSO Components – Control Environment
We did not maintain an effective control environment, which is the
foundation and structure necessary for effective internal control
over financial reporting, as evidenced by: (i) lack of segregation
of duties over individuals responsible for certain key control
activities; (ii) an insufficient number of personnel appropriately
qualified to perform control monitoring activities, including the
recognition of the risks and complexities of transactions; and
(iii) an insufficient number of personnel with the appropriate
level of GAAP knowledge and experience commensurate with our
financial reporting requirements. This control
environment material weakness contributed to the company not having
effective controls to ensure that potential errors or misstatements
may occur, but may not be detected.
Risk Assessment,
Monitoring Activities and Control Activities - Segregation of
Duties
We did not maintain adequate segregation of duties in our
accounting and financial reporting processes. We have not
appropriately restricted access to our accounting applications to
appropriate users and do not have processes in place that ensure
that appropriate segregation of duties is maintained. Certain
personnel have access to financial applications, programs and data
beyond that needed to perform their individual job responsibilities
and without independent monitoring. This allows for the creation,
review and processing of certain financial data without independent
review and authorization. There are also certain financial
personnel that have incompatible duties, including in the areas of
cash disbursements, payroll, and journal entry reviews. We have not
yet completed the process of assigning different people the
responsibilities of authorizing transactions, recording
transactions, and maintaining custody of assets to reduce the
opportunities to allow any person to be in a position to both
perpetrate and conceal errors or fraud in the normal course of the
person’s duties. Particularly in the areas of purchases, cash
disbursements, and payroll, certain individuals have incompatible
duties that limit our ability to identify and detect errors or
fraud that may occur.
Risk Assessment, Monitoring Activities and Control Activities -
Supervision and Review of Complex Accounting Areas
The Company lacks sufficient qualified personnel to review
conclusions reached regarding the accounting for complex
transactions and related analyses to record amounts resulting from
such transactions in our financial records. For calculations
related to stock-based compensation and the fair value of our
derivative liabilities in particular, there is a lack of review of
assumptions used and the underlying calculations made by the
preparer of this information that are then used to record amounts
in our financial statements. There is also a lack of review of
assumptions used and documentation of the sources of information
used in our evaluation of the fair value of our in-process research
and development intangible asset. Our internal control over these
processes would not allow for employees to detect a material
misstatement in these areas in the normal course of performing
their duties.
Risk Assessment, Information and Communication -
Authorization, Identification and Reporting of Related Party
Transactions
We do not have processes in place to ensure that all related party
transactions, including those entered into with or on behalf of
related parties, (1) have been identified, (2) are properly
authorized prior to entering into the transaction, and (3) are
properly monitored and evaluated for appropriate recording and
presentation in the financial statements.
Monitoring Activities and Control Activities - Financial Reporting
Process
We did not maintain an effective financial reporting process to
prepare financial statements in accordance with U.S. GAAP.
Specifically, our process lacked timely and complete financial
statement reviews and procedures to ensure all required disclosures
were made in our financial statements. We also lacked a process to
review information used to prepare our financial statements and
disclosures and did not have adequate segregation of duties over
preparation of the financial statements.
The material weaknesses identified by management could result in a
material misstatement to our annual or interim financial statements
that would not be prevented or detected. Management has concluded
that our internal control over financial reporting was not
effective as of September 30, 2016 due to the material
weaknesses identified.
A material weakness (within the meaning of PCAOB Auditing Standard
No. 5) is a deficiency, or a combination of deficiencies, in
internal control over financial reporting, such that there is a
reasonable possibility that a material misstatement of our annual
or interim financial statements will not be prevented or detected
on a timely basis. A significant deficiency is a deficiency, or a
combination of deficiencies, in internal control over financial
reporting that is less severe than a material weakness; yet
important enough to merit attention by those responsible for
oversight of Cocrystal’s financial reporting.
Because of its inherent limitations, internal control over
financial reporting may not prevent or detect misstatements.
Projections of any evaluation of effectiveness to future periods
are subject to the risk that controls may become inadequate because
of changes in conditions, or that the degree of compliance with the
policies and procedures may deteriorate.
Remediation Plan
The Company recognized that it did not maintain an effective
control environment during 2015 and the first nine months of 2016
which contributed to the company not having effective controls to
ensure that potential errors or misstatements may occur, but may
not be detected. During the first quarter of 2016, the company
began evaluation of the various risk control matrices to identify
the key versus non-key activities and related
controls. During the second and third quarters of 2016,
the Company continued to document its control environment and
implement both key controls and entity-level
controls. Those controls that have been implemented have
not been tested or validated by our auditors.
Segregation of Duties-The Company has developed a Segregation of
Duties Matrix and has updated business processes, documentation and
job roles to fully implement this matrix. We have
completed the process of assigning different people the
responsibilities of authorizing transactions, recording
transactions, and maintaining custody of assets to reduce the
opportunities to allow any person to be in a position to both
perpetrate and conceal errors or fraud in the normal course of the
person’s duties. Our financial software does not provide
robust administrative tools to effectively segregate roles,
especially with limited financial staff. The Company
will be evaluating a replacement financial system in 2016 but will
also focus on effective compensating controls until the financial
software can be upgraded or replaced.
Supervision and Review of Complex Accounting Areas-During 2015, the
Chief Financial Officer was responsible for calculations related to
stock-based compensation and the fair value of derivative
liabilities. As conducted in 2015, this process did not
provide the appropriate level of review of assumptions and
underlying calculations to detect material
misstatements. For the first nine months of 2016, the
Controller prepared these complex calculations and the Chief
Financial Officer reviewed those prior to adjusting any valuations
in the financial statements.
Authorization, Identification and Reporting of Related Party
Transactions- During 2015, the Company added a General Counsel
position to the organization. The Company is in the
process of developing contracting procedures that will require both
the General Counsel and Chief Financial Officer to review and
approve all new contracts and agreements, prior to approval by the
Chief Executive Officer. The Company is also in the
process of tightening procurement processes to ensure competitive
bids are requested and the vendors participating in these bids are
more thoroughly researched prior to any Company
commitments.
More formal financial statement review processes will be
established and will include the CEO and General Counsel, in
addition to the CFO. A disclosure checklist has been
developed to help ensure the adequacy and timeliness of all
financial statement disclosures.
Changes in Internal Control over Financial Reporting
The addition of a contract Controller to our organization in early
2016, has helped further segregate roles within the finance
organization. The Controller provided all the
calculations related to stock-based compensation and the fair value
of derivative liabilities. This Controller also
performed most of the journal entry processing and review of the
Accountant’s account analysis. These changes
resulted in having the CFO perform oversight and review instead of
direct processing. The other changes made to our
internal control over financial reporting during our most recently
completed fiscal quarter have been described above.
PART II — OTHER
INFORMATION
ITEM 1. LEGAL
PROCEEDINGS
From time to time, the Company is a party to, or otherwise involved
in, legal proceedings arising in the normal course of
business. As of the date of this report, except as
described below, the Company is not aware of any proceedings,
threatened or pending, against it which, if determined adversely,
would have a material effect on its business, results of
operations, cash flows or financial position.
The Company has been named as a party to a lawsuit filed on April
15, 2014 in Contra Costa County, California by an entity managed by
Mr. Daniel Fisher. Also named in this action are two of the
Company’s subsidiaries – BioZone Laboratories and
Cocrystal Discovery. The action seeks recovery on a
promissory note purportedly executed by BioZone Laboratories in the
principal amount of $295,000 in 2007, or almost seven years before
the Company’s acquisition of Cocrystal Discovery.
Motions challenging the sufficiency of the allegations in the
complaint were filed in the third quarter, 2014. The motions were
granted and plaintiff was given an opportunity to amend the
complaint, and plaintiff has filed an amended complaint. On July 2,
2015 the Company, along with its subsidiaries and other named
defendants, filed a motion to bifurcate the action, and stay
discovery on one of the causes of action. This motion was
granted on August 27, 2015 and the Court limited the scope of
discovery in the first phase of the case. The Court also
ordered that the Company post a bond for the amount of $295,000,
and the Company complied with the Order by posting the bond on
September 29, 2015. This is recorded as a short-term deposit.
At a hearing held April 19, 2016 the Court ordered the
parties to attempt resolution through a mediation. This
mediation took place on May 19 and no resolution resulted from that
session. A trial date has been set for February
2017.
On October 13, 2013, Plaintiff Shefa LMV, LLC ("Plaintiff") filed a
First Amended Complaint in Los Angeles Superior Court for civil
penalties and injunctive relief against numerous retailers and
manufacturers of products, and alleged violations of California
Health & Safety Code Sec. 25249.6 (part of the "Safe Drinking
Water and Toxic Enforcement Act") and California Business &
Professional Code Sec. 17200, et seq. (California's "Unfair
Competition Law"). The case is captioned Shefa LMV, LLC
v. Walgreens Co., et al., Los Angeles Superior Court Case No.
BC520416. The complaint alleges that the retailers and
manufacturers failed to place a clear and reasonable warning on the
products which contained "Cocamide DEA" pursuant to the Safe
Drinking Water and Toxic Enforcement Act, and further requested
that the defendants be enjoined from manufacturing or selling
products with Cocamide DEA in the State of
California. Numerous actions that had been filed
alleging similar claims against defendants who manufactured and/or
sold Cocamide DEA products have been coordinated, with a new
Judicial Council Coordination Proceeding Case No. JCCP
4765. On October 17, 2014, Plaintiff filed an amendment
to the Complaint, adding our subsidiary BioZone Laboratories,
Inc. a California corporation, as Doe Defendant No.
9. The Company filed an Answer to the First Amended
Complaint on October 13, 2015. No discovery has taken
place yet.
In October 2015, Cocrystal Pharma, Inc. received a subpoena from
the staff of the Securities and Exchange Commission seeking the
production of documents. The Company is fully cooperating
with the inquiry. The Company cannot predict or determine
whether any proceeding may be instituted in connection with the
subpoena or the outcome of any proceeding that may be
instituted.
On December 23, 2015, the Company issued notice of default letters
to 580 Garcia Properties, Daniel Fisher and Sharon Fisher for
failure to remit certain payments on a promissory note executed
between the parties in June 2014. The Company also exercised a
failure to pay provision within that note to escalate the interest
rate from 7.24% to 11.24%. On September 27, 2016, The
Notice of Default and Election to Sell under Deed of Trust was
formally filed and recorded in Contra Costa County California. As
of September 8, 2016, the additional amounts due the Company total
approximately $206,000. Due to the contingent nature of this
default action, Cocrystal Pharma, Inc. has not recorded a
receivable for this amount in its financial
statements.
ITEM 1.A RISK
FACTORS
You should consider carefully the following risk factors, together
with all of the other information included or incorporated in our
Annual Report for the year ended December 31, 2015. Each of these
risk factors, either alone or taken together, could adversely
affect our business, operating results and financial condition, and
adversely affect the value of an investment in our common stock.
There may be additional risks that we do not know of or that we
believe are immaterial that could also impair our business and
financial position.
RISK
FACTORS
Investing in our common stock involves a high degree of
risk. You should carefully consider the following risk
factors before deciding whether to invest in the
Company. There have been no material changes to our risk
factors since our Annual Report on Form 10-K for the year ended
December 31, 2015, except for the following:
RISKS RELATED TO OUR FINANCIAL CONDITION AND NEED FOR ADDITIONAL
CAPITAL
If we do not raise additional debt or equity capital, we may not be
able to remain operational.
Based on cash on hand as of September 30, 2016 of $5.9 million
which includes third quarter 2016 financing received of $4.0
million, Cocrystal does not have the capital to finance operations
for the next 12 months. This raises substantial doubt about our
ability to continue operations over the next twelve months and be a
going concern.
We have devoted the majority of our financial resources to research
and development. We have financed our operations primarily through
the sale of equity securities. The results of our operations will
depend, in part, on the rate of future expenditures and our ability
to obtain funding through equity or debt financings, strategic
alliances or grants. We anticipate our expenses will increase
substantially if and as we continue our research, preclinical and
clinical development of our product candidates. We anticipate that
if we undertake additional clinical studies our expenses will
increase even further.
If we must secure additional financing, such additional fundraising
efforts may divert our management from our day-to-day activities,
which may adversely affect our ability to develop and commercialize
product candidates. We cannot guarantee that future financing will
be available in sufficient amounts or on terms acceptable to us, if
at all. If we cannot raise additional capital when required or on
acceptable terms, we may be required to:
●
|
significantly delay, scale back or discontinue the development or
commercialization of any product candidates;
|
●
|
seek strategic alliances for research and development programs at
an earlier stage than otherwise would be desirable or on terms less
favorable than might otherwise be available; or
|
●
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relinquish or license on unfavorable terms, our rights to
technologies or any product candidates we otherwise would seek to
develop or commercialize ourselves.
|
If we are unable to raise additional capital in sufficient amounts
or on terms acceptable to us, we will be prevented from pursuing
development and commercialization efforts, which will have a
material adverse effect on our business, operating results and
prospects or sufficient enough to render the Company unable to
continue operations at all.
RISKS RELATED TO OUR BUSINESS OPERATIONS AND INDUSTRY
If we lose key management or scientific personnel, cannot recruit
qualified employees, directors, officers, or other personnel or
experience increases in our compensation costs, our business may
materially suffer.
We depend on principal members of our executive and research teams,
the loss of whose services may adversely impact the achievement of
our objectives. During July 2016, our Chief Executive
Officer, Jeffrey Meckler and our Chief Medical Officer, Dr. Douglas
Mayers resigned. As of the filing date of this report, neither of
these key positions have been filled. Our former CEO and current
board member, Gary Wilcox is acting as Interim Chief Executive
Officer. We may not be able to attract and retain key personnel on
acceptable terms considering the competition among numerous
pharmaceutical companies for individuals with similar skill
sets. Because of this competition, our compensation
costs may increase significantly. If we lose additional
key employees, our business may suffer. Our future success will
also depend, in part, on the continued service of our key
scientific and management personnel and our ability to identify,
hire, and retain additional personnel.
RISKS RELATED TO RELIANCE ON THIRD PARTIES
If we form strategic alliances which are unsuccessful or are
terminated, we may be unable to develop or commercialize certain
product candidates and we may be unable to generate revenues from
our development programs.
Cocrystal Pharma has relied on chemistry resources at Emory
University to perform certain studies and tests on our HCV
nucleoside candidates. Cocrystal also performs certain
studies and tests for Emory University. Neither Cocrystal
Pharma nor Emory University have quantified the value of these
services at this time and neither have been billed for these
services.
RISKS RELATED TO OUR INTELLECTUAL PROPERTY
If we cannot obtain or protect intellectual property rights related
to our future products and product candidates, we may not be able
to compete effectively in our markets.
Cocrystal Pharma may seek intellectual property protection on its
compounds, processes and methods through the use of patents.
The issuance, viability and successful maintenance or
prosecution of patents are subject to many factors and
interpretations of law that may adversely affect the ultimate
availability of patent protection and could have an adverse
effect on valuation of any of Cocrystal's assets or ability to
realize value on such assets.
ITEM 2. UNREGISTERED
SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
On March 9, 2016, we accepted subscription agreements representing
investor commitments totaling $5,004,371 in a private placement
offering of 9,812,492 shares of our common stock at a purchase
price of $0.51 per share. The purchasers included seven members of
our board of directors including Dr. Raymond F. Schinazi and Dr.
Phil Frost. As of the date of this report, we have received all of
the committed funds.
On September 1, 2016, we closed on proceeds of $4,008,201 in a
private placement offering of 9,776,100 shares of our common stock
at a purchase price of $0.41 per share. The purchasers included
three members of our board of directors, including Chairman Dr.
Raymond F. Schinazi, Interim Chief Executive Officer Dr. Gary
Wilcox, and Dr. David Block. In addition, OPKO Health, Inc., of
which one of our director's Dr. Phillip Frost is Chairman and Chief
Executive Officer, invested in the offering.
We intend to use the net proceeds of these offerings for working
capital and general corporate purposes.
All of the securities were issued and sold in reliance upon
the exemption from registration contained in Section 4(a)(2) of the
Securities Act of 1933 (the “Act”) and Rule 506
promulgated thereunder. These securities may not be offered
or sold in the United States in the absence of an effective
registration statement or exemption from the registration
requirements under the Act. The investors are accredited investors
and there was no general solicitation.
ITEM 3. DEFAULTS UPON SENIOR
SECURITIES
None
ITEM 4. MINE SAFETY
DISCLOSURES
Not Applicable
ITEM 5. OTHER
None
ITEM 6. EXHIBITS
The exhibits listed in the accompanying “Index to
Exhibits” are filed or incorporated by reference as part of
this Form 10-Q.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of
1934, the Registrant has duly caused this report to be signed on
its behalf by the undersigned, thereunto duly
authorized.
|
Cocrystal Pharma, Inc.
|
|
|
|
|
Dated: November 9, 2016
|
By:
|
/s/Gary
Wilcox
|
|
Gary Wilcox
Interim Chief Executive Officer
(Principal Executive Officer)
|
|
Dated: November 9, 2016
|
By:
|
/s/Curtis
Dale
|
|
Interim Chief Financial Officer
(Principal Financial Officer)
|
EXHIBIT INDEX
|
|
|
|
Incorporated by Reference
|
|
||
Exhibit No.
|
|
Exhibit Description
|
|
Form
|
Date
|
Number
|
Filed or Furnished Herewith
|
10.1
|
|
Form
of Securities Purchase Agreement
|
|
8-K
|
9/2/2016
|
10.1
|
Filed
|
31.1
|
|
Certification of Principal Executive Officer
(302)
|
|
|
|
|
Filed
|
31.2
|
|
Certification of Principal Financial
Officer (302)
|
|
|
|
|
Filed
|
32.1
|
|
Certification
of Principal Executive Officer and Principal Financial Officer
(906)
|
|
|
|
|
Furnished**
|
101.INS
|
|
XBRL Instance Document
|
|
|
|
|
Filed
|
101.SCH
|
|
XBRL Taxonomy Extension Schema Document
|
|
|
|
|
Filed
|
101.CAL
|
|
XBRL Taxonomy Extension Calculation Linkbase
Document
|
|
|
|
|
Filed
|
101.LAB
|
|
XBRL Taxonomy Extension Label
Linkbase Document
|
|
|
|
|
Filed
|
101.PRE
|
|
XBRL Taxonomy Extension Presentation Linkbase
Document
|
|
|
|
|
Filed
|
** This exhibit is being furnished rather than filed and shall not
be deemed incorporated by reference into any filing, in accordance
with Item 601 of Regulation S-K.
Copies of this report (including the financial statements) and any
of the exhibits referred to above will be furnished at no cost to
our shareholders who make a written request to our Corporate
Secretary at Cocrystal Pharma, Inc., 1860 Montreal Road, Tucker GA
30084.
-11-