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Share Name | Share Symbol | Market | Type |
---|---|---|---|
EOM Pharmaceutical Holdings Inc (PK) | USOTC:IMUC | OTCMarkets | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
-0.0429 | -21.68% | 0.155 | 0.15 | 0.1979 | 0.155 | 0.155 | 0.155 | 1,375 | 19:08:05 |
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ý
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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¨
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Delaware
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93-1301885
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(State or other jurisdiction of
incorporation or organization)
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(IRS Employer
Identification No.)
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23622 Calabasas Road, Suite 300
Calabasas, California
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91302
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(Address of principal executive offices)
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(Zip code)
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Large accelerated filer
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¨
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Accelerated Filer
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¨
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Non-accelerated filer (Do not check if a smaller reporting company)
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¨
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Smaller reporting company
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ý
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Emerging growth company
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¨
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Page
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June 30, 2017
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December 31, 2016
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||||
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(unaudited)
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|
|
||||
Assets
|
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
1,814,005
|
|
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$
|
11,437,118
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Supplies for clinical trials
|
—
|
|
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1,186,186
|
|
||
Other assets
|
2,589,032
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|
|
791,485
|
|
||
Total current assets
|
4,403,037
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|
13,414,789
|
|
||
Property and equipment, net
|
76,633
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|
|
109,823
|
|
||
Supplies for clinical trials
|
—
|
|
|
1,309,648
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|
||
Deposits
|
—
|
|
|
1,955,514
|
|
||
Deferred offering costs
|
330,871
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|
|
100,216
|
|
||
Total assets
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$
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4,810,541
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$
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16,889,990
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Liabilities and Shareholders’ Equity (Deficit)
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|
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||||
Current liabilities:
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|
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||||
Accounts payable
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$
|
4,250,826
|
|
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$
|
1,342,126
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|
Accrued compensation and benefits
|
201,643
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|
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1,109,864
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|
||
Accrued liabilities
|
3,267,704
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|
786,953
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|
||
Total current liabilities
|
7,720,173
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|
3,238,943
|
|
||
CIRM liability
|
—
|
|
|
6,945,741
|
|
||
Warrant liability
|
27,862
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|
|
573,560
|
|
||
Total liabilities
|
7,748,035
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10,758,244
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|
||
Commitments and contingencies (Note 5)
|
|
|
|
||||
Shareholders’ equity (deficit):
|
|
|
|
||||
Preferred stock $0.0001 par value, 1,000,000 shares authorized; 0 shares outstanding as of June 30, 2017 and December 31, 2016
|
—
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|
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—
|
|
||
Common stock, $0.0001 par value; 25,000,000 shares authorized;
3,551,575 and 3,444,859 shares issued and outstanding as of
June 30, 2017 and December 31, 2016, respectively
|
355
|
|
|
344
|
|
||
Additional paid-in capital
|
102,719,728
|
|
|
102,354,844
|
|
||
Accumulated deficit
|
(105,657,577
|
)
|
|
(96,223,442
|
)
|
||
Total shareholders’ equity (deficit)
|
(2,937,494
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)
|
|
6,131,746
|
|
||
Total liabilities and shareholders’ equity (deficit)
|
$
|
4,810,541
|
|
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$
|
16,889,990
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|
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For the Three Months Ended
June 30, 2017 |
|
For the Three Months Ended
June 30, 2016 |
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For the Six Months Ended
June 30, 2017 |
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For the Six Months Ended
June 30, 2016 |
||||||||
Revenues
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$
|
—
|
|
|
$
|
—
|
|
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$
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—
|
|
|
$
|
—
|
|
Expenses:
|
|
|
|
|
|
|
|
||||||||
Research and development
|
10,353,601
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|
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4,433,222
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|
15,039,321
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|
|
9,170,797
|
|
||||
General and administrative
|
988,266
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|
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1,049,815
|
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1,781,444
|
|
|
2,149,647
|
|
||||
Total expenses
|
11,341,867
|
|
|
5,483,037
|
|
|
16,820,765
|
|
|
11,320,444
|
|
||||
Loss before other income (expense)
|
|
|
|
|
|
|
|
||||||||
and taxes
|
(11,341,867
|
)
|
|
(5,483,037
|
)
|
|
(16,820,765
|
)
|
|
(11,320,444
|
)
|
||||
Interest income
|
381
|
|
|
6,397
|
|
|
4,175
|
|
|
8,911
|
|
||||
Interest expense
|
(430,024
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)
|
|
(281,996
|
)
|
|
(882,683
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)
|
|
(546,823
|
)
|
||||
Financing expense
|
—
|
|
|
(16,595
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)
|
|
—
|
|
|
(31,231
|
)
|
||||
Change in fair value of
|
|
|
|
|
|
|
|
|
|
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|
||||
warrant liability
|
442,922
|
|
|
445,660
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|
|
545,698
|
|
|
926,671
|
|
||||
Derecognition of CIRM liability
|
7,719,440
|
|
|
—
|
|
|
7,719,440
|
|
|
—
|
|
||||
Loss before provision for income taxes
|
(3,609,148
|
)
|
|
(5,329,571
|
)
|
|
(9,434,135
|
)
|
|
(10,962,916
|
)
|
||||
Provision for income taxes
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||
Net loss
|
$
|
(3,609,148
|
)
|
|
$
|
(5,329,571
|
)
|
|
$
|
(9,434,135
|
)
|
|
$
|
(10,962,916
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)
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Net loss per share
|
$
|
(1.02
|
)
|
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$
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(2.30
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)
|
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$
|
(2.66
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)
|
|
$
|
(4.76
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)
|
Weighted average number of
shares outstanding basic and diluted:
|
3,551,575
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|
|
2,321,957
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|
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3,550,550
|
|
|
2,301,802
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|
|
Common Stock
|
|
|
|
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|||||||||||
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Shares
|
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Amount
|
|
Additional Paid-in Capital
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Accumulated Deficit
|
|
Total
|
|||||||||
Balance at December 31, 2016
|
3,444,859
|
|
|
$
|
344
|
|
|
$
|
102,354,844
|
|
|
$
|
(96,223,442
|
)
|
|
$
|
6,131,746
|
|
Exercise of warrants
|
102,500
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|
|
10
|
|
|
40,990
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|
|
—
|
|
|
41,000
|
|
||||
Stock based compensation
|
4,216
|
|
|
1
|
|
|
323,894
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|
|
—
|
|
|
323,895
|
|
||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(9,434,135
|
)
|
|
(9,434,135
|
)
|
||||
Balance at June 30, 2017
|
3,551,575
|
|
|
$
|
355
|
|
|
$
|
102,719,728
|
|
|
$
|
(105,657,577
|
)
|
|
$
|
(2,937,494
|
)
|
|
For the Six Months Ended
June 30, 2017 |
|
For the Six Months Ended
June 30, 2016 |
||||
Cash flows from operating activities:
|
|
|
|
||||
Net loss
|
$
|
(9,434,135
|
)
|
|
$
|
(10,962,916
|
)
|
Adjustments to reconcile net loss to net cash used in
operating activities:
|
|
|
|
||||
Depreciation
|
33,190
|
|
|
40,963
|
|
||
Change in fair value of warrant liability
|
(545,698
|
)
|
|
(926,671
|
)
|
||
Financing expense
|
—
|
|
|
31,231
|
|
||
Stock-based compensation
|
323,895
|
|
|
480,947
|
|
||
Derecognition of CIRM liability
|
(7,719,440
|
)
|
|
—
|
|
||
Accrued interest on CIRM award
|
882,683
|
|
|
546,823
|
|
||
Write-off of supplies for clinical trials
|
2,349,404
|
|
|
—
|
|
||
Changes in assets and liabilities:
|
|
|
|
||||
Other assets
|
157,967
|
|
|
595,679
|
|
||
Supplies for clinical trials
|
146,430
|
|
|
(293,100
|
)
|
||
Accounts payable
|
2,843,974
|
|
|
(531,531
|
)
|
||
Accrued compensation and benefits
|
(908,221
|
)
|
|
(459,562
|
)
|
||
Accrued liabilities
|
2,346,767
|
|
|
284,005
|
|
||
Net cash used in operating activities
|
(9,523,184
|
)
|
|
(11,194,132
|
)
|
||
Cash flows from investing activities:
|
|
|
|
||||
Purchase of property and equipment
|
—
|
|
|
(4,015
|
)
|
||
Net cash used in investing activities
|
—
|
|
|
(4,015
|
)
|
||
Cash flows from financing activities:
|
|
|
|
||||
Proceeds from the issuance of common stock through controlled equity offering
|
—
|
|
|
691,187
|
|
||
Proceeds from the exercise of warrants
|
41,000
|
|
|
—
|
|
||
Deferred offering costs
|
(140,929
|
)
|
|
(148,663
|
)
|
||
Net cash (used in) provided by financing activities
|
(99,929
|
)
|
|
542,524
|
|
||
(Decrease) in cash and cash equivalents
|
(9,623,113
|
)
|
|
(10,655,623
|
)
|
||
Cash and cash equivalents, beginning of period
|
11,437,118
|
|
|
22,604,481
|
|
||
Cash and cash equivalents, end of period
|
$
|
1,814,005
|
|
|
$
|
11,948,858
|
|
Supplemental cash flows disclosures:
|
|
|
|
||||
Interest expense paid
|
$
|
—
|
|
|
$
|
—
|
|
Income taxes paid
|
$
|
—
|
|
|
$
|
—
|
|
Supplemental non-cash disclosures:
|
|
|
|
||||
Financing costs included in accounts payable
|
$
|
89,726
|
|
|
$
|
79,440
|
|
Deposits reclassified to other current assets
|
$
|
1,922,218
|
|
|
$
|
—
|
|
CIRM liability reclassified to other current assets
|
$
|
108,984
|
|
|
$
|
—
|
|
|
|
|
|
|
Six Months Ended
June 30, 2017 |
|
Six Months Ended
June 30, 2016 |
||
Risk-free interest rate
|
—
|
%
|
|
1.3
|
%
|
Expected dividend yield
|
None
|
|
|
None
|
|
Expected life
|
0.0 years
|
|
|
6.0 years
|
|
Expected volatility
|
—
|
%
|
|
82.7
|
%
|
Expected forfeitures
|
—
|
%
|
|
—
|
%
|
|
June 30, 2017
|
|
December 31, 2016
|
||||
Computers
|
$
|
70,960
|
|
|
$
|
70,960
|
|
Research equipment
|
305,066
|
|
|
305,066
|
|
||
|
376,026
|
|
|
376,026
|
|
||
Accumulated depreciation
|
(299,393
|
)
|
|
(266,203
|
)
|
||
|
$
|
76,633
|
|
|
$
|
109,823
|
|
|
Options
|
|
Weighted
Average
Exercise
Price
|
|
Weighted
Average
Remaining
Contractual
Term
|
|
Aggregate
Intrinsic
Value
|
||||||
Outstanding December 31, 2016
|
162,665
|
|
|
$
|
43.11
|
|
|
—
|
|
|
—
|
|
|
Granted
|
—
|
|
|
$
|
—
|
|
|
—
|
|
|
—
|
|
|
Exercised
|
—
|
|
|
$
|
—
|
|
|
—
|
|
|
—
|
|
|
Forfeited or expired
|
(8,753
|
)
|
|
$
|
59.12
|
|
|
—
|
|
|
—
|
|
|
Outstanding June 30, 2017
|
153,912
|
|
|
$
|
42.20
|
|
|
6.12
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
||||||
Vested at June 30, 2017
|
112,567
|
|
|
$
|
49.37
|
|
|
5.58
|
|
|
$
|
—
|
|
|
June 30, 2017
|
|
June 30, 2016
|
||||
Balance – January 1
|
$
|
573,560
|
|
|
$
|
1,958,775
|
|
Issuance of warrants and effect of repricing
|
—
|
|
|
31,231
|
|
||
Exercise of warrants
|
—
|
|
|
—
|
|
||
(Gain) or loss included in earnings
|
(545,698
|
)
|
|
(926,671
|
)
|
||
Balance – June 30
|
$
|
27,862
|
|
|
$
|
1,063,335
|
|
|
June 30, 2017
|
|
June 30, 2016
|
||
Income tax benefit at the federal statutory rate
|
(34
|
)%
|
|
(34
|
)%
|
State income tax benefit, net of federal tax benefit
|
(6
|
)%
|
|
(6
|
)%
|
Change in fair value of warrant liability
|
8
|
%
|
|
4
|
%
|
Change in valuation allowance for deferred tax assets
|
12
|
%
|
|
36
|
%
|
Other
|
20
|
%
|
|
—
|
%
|
Total
|
—
|
%
|
|
—
|
%
|
|
June 30, 2017
|
|
December 31, 2016
|
||||
Net operating loss carryforwards
|
28,499,782
|
|
|
27,267,545
|
|
||
Stock-based compensation
|
2,728,866
|
|
|
3,090,903
|
|
||
Less valuation allowance
|
(31,228,648
|
)
|
|
(30,358,448
|
)
|
||
Net deferred tax asset
|
$
|
—
|
|
|
$
|
—
|
|
•
|
the need to conduct larger, more expensive and longer clinical trials to obtain the data necessary for submission for product approval to regulatory agencies;
|
•
|
the capability to manufacture product at the scale and quantities required to meet regulatory approval requirements and the development and commercial requirements for the product;
|
•
|
the costs to obtain qualified commercial development of infrastructure and activities related to the commercialization of our products;
|
•
|
the rate of progress and cost of our research and development and clinical trial activities; and
|
•
|
the introduction into the marketplace of competing products and other adverse market developments.
|
•
|
engage corporate partners to assist in developing, funding, testing, manufacturing and marketing our vaccine product candidates or any future product candidates that we may develop;
|
•
|
satisfy the regulatory requirements for acceptable pre-clinical and clinical trial studies or to timely enroll patients;
|
•
|
establish and demonstrate or satisfactorily complete the research to demonstrate at various stages the pre-clinical and clinical efficacy and safety of our vaccine product candidates or any future product candidates that we may develop;
|
•
|
apply for and obtain the necessary regulatory approvals from the FDA and the appropriate foreign regulatory agencies;
|
•
|
market our vaccine product candidates or any future product candidates that we may develop to achieve acceptance and use by the medical community and patients in general and produce revenues; and
|
•
|
attract and retain, on acceptable terms, qualified technical, commercial and administrative staff for the continued development and growth of our business.
|
•
|
survive and persist in the desired location;
|
•
|
provide the intended therapeutic benefits;
|
•
|
properly integrate into existing tissue in the desired manner; or
|
•
|
achieve therapeutic benefits equal to or better than the standard of treatment at the time of testing.
|
•
|
design of the trial protocol;
|
•
|
the size of the patient population;
|
•
|
eligibility criteria for the study in question;
|
•
|
perceived risks and benefits of the product candidate under study;
|
•
|
availability of competing therapies and clinical trials;
|
•
|
efforts to facilitate enrollment in clinical trials;
|
•
|
the ability to monitor patients adequately during and after treatment; and
|
•
|
proximity and availability of clinical trial sites for prospective patients.
|
•
|
the perceived safety and efficacy of our products;
|
•
|
the prevalence and severity of any side effects;
|
•
|
our ability to gain access to the entire market through distributor arrangements;
|
•
|
the willingness of the target patient population to try new products and of physicians to prescribe our products;
|
•
|
the effectiveness of our marketing strategy and distribution support;
|
•
|
the timing of our receipt of any marketing approvals, the terms of any approvals and the countries in which approvals are obtained;
|
•
|
the availability of government and third-party payor reimbursement;
|
•
|
the pricing of our product candidates, particularly as compared to alternative treatments; and
|
•
|
the availability of alternative effective forms of treatments, at that time, for the diseases that the product candidates we are developing are intended to treat.
|
•
|
our ability to obtain U.S. and foreign marketing approvals for our product candidates on a timely basis;
|
•
|
the level of acceptance of our products by physicians, compared to those of competing products or therapies;
|
•
|
our ability to have our products manufactured on a commercial scale;
|
•
|
the effectiveness of sales and marketing efforts on behalf of our products;
|
•
|
our ability to meet demand for our products;
|
•
|
our ability to secure insurance reimbursement for our products;
|
•
|
the price of our products relative to competing products or therapies;
|
•
|
our ability to enter into collaborations with third parties to market our products;
|
•
|
our ability to recruit and retain appropriate management and scientific personnel; and
|
•
|
our ability to develop a commercial-scale research and development, manufacturing and marketing infrastructure, either on our own or with one or more future strategic partners.
|
•
|
incur substantial monetary damages;
|
•
|
encounter significant delays in marketing our current product candidates or any future product candidates that we may develop; or
|
•
|
be unable to conduct or participate in the manufacture, use, offer for sale or sale of product candidates or methods of treatment requiring licenses.
|
•
|
the progress and success of clinical trials and preclinical activities (including studies and manufacture of materials) of our product candidates conducted by us or our collaborative partners or licensees;
|
•
|
the receipt or failure to receive the additional funding necessary to conduct our business;
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•
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selling by large stockholders;
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presentations of detailed clinical trial data at medical and scientific conferences and investor perception thereof;
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•
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announcements of technological innovations or new commercial products by our competitors or us;
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•
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developments concerning proprietary rights, including patents by our competitors or us;
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•
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developments concerning our collaborations;
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•
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publicity regarding actual or potential medical results relating to products under development by our competitors or us;
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•
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regulatory developments in the United States and foreign countries;
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•
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manufacturing or supply disruptions at our contract manufacturers, or failure by our contract manufacturers to obtain or maintain approval of the FDA or comparable regulatory authorities;
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•
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litigation or arbitration;
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•
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economic and other external factors or other disaster or crisis; and
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•
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period-to-period fluctuations in financial results.
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Dated: August 14, 2017
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IMMUNOCELLULAR THERAPEUTICS, LTD.
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By:
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/s/ Anthony Gringeri
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Name:
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Anthony Gringeri, Ph.D.
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Title:
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President and Chief Executive Officer
(Principal Executive Officer)
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By:
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/s/ David Fractor
|
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Name:
|
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David Fractor
|
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Title:
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Chief Financial Officer
(Principal Financial and Accounting Officer)
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Exhibit No.
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Description
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3.1*
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Certificate of Amendment to Amended and Restated Certificate of Incorporation.
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3.2**
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|
Certificate of Designation of Preferences, Rights and Limitations of Series B 8.0% Mandatorily Convertible Preferred Stock.
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4.1
|
|
Form of Series 1 Warrant to Purchase Series B 8.0% Mandatorily Convertible Preferred Stock.
|
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|
|
4.2
|
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Form of Series 2 Warrant to Purchase Series B 8.0% Mandatorily Convertible Preferred Stock.
|
|
|
|
4.3
|
|
Form of Series 3 Warrant to Purchase Series B 8.0% Mandatorily Convertible Preferred Stock.
|
|
|
|
31.1
|
|
Certification of the Registrant’s Principal Executive Officer under Exchange Act Rule 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
31.2
|
|
Certification of the Registrant’s Principal Financial Officer under Exchange Act Rule 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
32.1
|
|
Certification of the Registrant’s Principal Executive Officer under 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
32.2
|
|
Certification of the Registrant’s Principal Financial Officer under 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
101.INS
|
|
XBRL Instance Document
|
|
|
|
101.SCH
|
|
XBRL Taxonomy Extension Schema Document
|
|
|
|
101.CAL
|
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
|
|
|
101.LAB
|
|
XBRL Taxonomy Extension Labels Linkbase Document
|
|
|
|
101.PRE
|
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
|
|
|
101.DEF
|
|
XBRL Taxonomy Extension Definition Linkbase Document
|
|
|
|
*
|
|
Previously filed by us on June 22, 2017 as Exhibit 3.1 to our Form 8-K, File No. 001-35560 and incorporated herein by reference.
|
|
|
|
**
|
|
Previously filed by us on July 13, 2017 as Exhibit 3.11 to our Registration Statement on Form S-1, File No. 333-215331 and incorporated herein by reference.
|
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