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| þ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
| o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
| Delaware | 84-1318182 | |
| (State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) | |
| 12390 El Camino Real, Suite 150, San Diego, CA | 92130 | |
| (Address of principal executive offices) | (Zip Code) |
| Large accelerated filer o | Accelerated filer o | Non-accelerated filer o | Smaller reporting company þ | |||
| Page | ||||||||
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| 23 | ||||||||
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| Exhibit 31.1 | ||||||||
| Exhibit 31.2 | ||||||||
| Exhibit 32.1 | ||||||||
| EX-101 INSTANCE DOCUMENT | ||||||||
| EX-101 SCHEMA DOCUMENT | ||||||||
| EX-101 CALCULATION LINKBASE DOCUMENT | ||||||||
| EX-101 LABELS LINKBASE DOCUMENT | ||||||||
| EX-101 PRESENTATION LINKBASE DOCUMENT | ||||||||
| June 30, | December 31, | |||||||
| 2011 | 2010 (1) | |||||||
|
Assets
|
||||||||
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Current assets:
|
||||||||
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Cash and cash equivalents
|
$ | 41,955,977 | $ | 27,978,823 | ||||
|
Interest and other receivables
|
271 | 1,980 | ||||||
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Prepaid expenses
|
776,178 | 428,276 | ||||||
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|
||||||||
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|
||||||||
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Total current assets
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42,732,426 | 28,409,079 | ||||||
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||||||||
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Property and equipment, net
|
57,407 | 44,254 | ||||||
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In-process research and development
|
6,549,000 | | ||||||
|
Goodwill
|
403,795 | | ||||||
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Other assets
|
419,015 | 33,484 | ||||||
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||||||||
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||||||||
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Total assets
|
$ | 50,161,643 | $ | 28,486,817 | ||||
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||||||||
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||||||||
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Liabilities and Stockholders Equity
|
||||||||
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Current liabilities:
|
||||||||
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Accounts payable
|
$ | 872,488 | $ | 479,780 | ||||
|
Accrued liabilities
|
1,080,466 | 864,857 | ||||||
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Accrued compensation and payroll taxes
|
411,139 | 456,839 | ||||||
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|
||||||||
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||||||||
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Total current liabilities
|
2,364,093 | 1,801,476 | ||||||
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||||||||
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|
||||||||
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Contingent consideration
|
1,400,000 | | ||||||
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||||||||
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|
||||||||
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Stockholders equity:
|
||||||||
|
Common stock, $0.001 par value; 500,000,000 shares
authorized; 26,465,709 and 15,480,302 shares issued and
outstanding at June 30, 2011 and December 31, 2010,
respectively
|
26,466 | 15,480 | ||||||
|
Additional paid-in capital
|
209,841,368 | 182,798,982 | ||||||
|
Accumulated other comprehensive income
|
7,466 | | ||||||
|
Deficit accumulated during the development stage
|
(163,477,750 | ) | (156,129,121 | ) | ||||
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|
||||||||
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|
||||||||
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Total stockholders equity
|
46,397,550 | 26,685,341 | ||||||
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||||||||
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|
||||||||
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Total liabilities and stockholders equity
|
$ | 50,161,643 | $ | 28,486,817 | ||||
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||||||||
| (1) |
The balance sheet at December 31, 2010 has been derived from audited financial statements at
that date. It does not include, however, all of the information and notes required by accounting
principles generally accepted in the United States of America for complete financial statements.
|
(1)
| Inception | ||||||||||||||||||||
| (June 12, 1996) | ||||||||||||||||||||
| Three months ended June 30, | Six months ended June 30, | through | ||||||||||||||||||
| 2011 | 2010 | 2011 | 2010 | June 30, 2011 | ||||||||||||||||
|
|
||||||||||||||||||||
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Licensing revenue
|
$ | | $ | | $ | | $ | | $ | 1,300,000 | ||||||||||
|
Net sales
|
| | | | 174,830 | |||||||||||||||
|
Grant revenue
|
| | | | 618,692 | |||||||||||||||
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|
||||||||||||||||||||
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Total net revenue
|
| | | | 2,093,522 | |||||||||||||||
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|
||||||||||||||||||||
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Cost of sales
|
| | | | 51,094 | |||||||||||||||
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|
||||||||||||||||||||
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Gross margin
|
| | | | 2,042,428 | |||||||||||||||
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|
||||||||||||||||||||
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Operating expenses:
|
||||||||||||||||||||
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Research and development
|
1,342,573 | 633,766 | 1,953,866 | 1,873,095 | 74,164,833 | |||||||||||||||
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Selling, general and administrative
|
1,824,108 | 1,303,217 | 3,397,854 | 2,477,893 | 56,355,068 | |||||||||||||||
|
Transaction-related expenses
|
1,229,418 | | 2,028,923 | | 2,359,292 | |||||||||||||||
|
Depreciation and amortization
|
10,366 | 5,767 | 20,237 | 11,647 | 10,917,855 | |||||||||||||||
|
In-process research and development
|
| | | | 10,422,130 | |||||||||||||||
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Impairment loss
|
| | | | 5,702,130 | |||||||||||||||
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Equity in loss of investee
|
| | | | 178,936 | |||||||||||||||
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|
||||||||||||||||||||
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Total operating expenses
|
4,406,465 | 1,942,750 | 7,400,880 | 4,362,635 | 160,100,244 | |||||||||||||||
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Loss from operations
|
(4,406,465 | ) | (1,942,750 | ) | (7,400,880 | ) | (4,362,635 | ) | (158,057,816 | ) | ||||||||||
|
Loss on fair value of warrants
|
| | | | (12,239,688 | ) | ||||||||||||||
|
Interest income
|
10,998 | 23,308 | 43,869 | 41,748 | 4,725,930 | |||||||||||||||
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Interest expense
|
| | | (1,629 | ) | (180,719 | ) | |||||||||||||
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Other income (expense)
|
3,277 | | 8,382 | | 71,757 | |||||||||||||||
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||||||||||||||||||||
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Loss before cumulative effect of
change in accounting principle
|
(4,392,190 | ) | (1,919,442 | ) | (7,348,629 | ) | (4,322,516 | ) | (165,680,536 | ) | ||||||||||
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|
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Cumulative effect of change in
accounting principle
|
| | | | (25,821 | ) | ||||||||||||||
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|
||||||||||||||||||||
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Net loss
|
(4,392,190 | ) | (1,919,442 | ) | (7,348,629 | ) | (4,322,516 | ) | (165,706,357 | ) | ||||||||||
|
|
||||||||||||||||||||
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Preferred stock dividends
|
| | | | (621,240 | ) | ||||||||||||||
|
Deemed dividends on preferred stock
|
| (3,124,876 | ) | | (5,639,796 | ) | (10,506,683 | ) | ||||||||||||
|
|
||||||||||||||||||||
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|
||||||||||||||||||||
|
Net loss applicable to common stock
|
$ | (4,392,190 | ) | $ | (5,044,318 | ) | $ | (7,348,629 | ) | $ | (9,962,312 | ) | $ | (176,834,280 | ) | |||||
|
|
||||||||||||||||||||
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|
||||||||||||||||||||
|
Net loss per common share basic
and diluted
|
$ | (0.17 | ) | $ | (0.39 | ) | $ | (0.30 | ) | $ | (0.86 | ) | ||||||||
|
|
||||||||||||||||||||
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|
||||||||||||||||||||
|
Weighted average shares basic and
diluted
|
26,250,259 | 12,886,826 | 24,512,515 | 11,522,885 | ||||||||||||||||
|
|
||||||||||||||||||||
(2)
| Inception | ||||||||||||
| (June 12, 1996) | ||||||||||||
| Six months ended June 30, | through | |||||||||||
| 2011 | 2010 | June 30, 2011 | ||||||||||
|
|
||||||||||||
|
Cash flows from operating activities:
|
||||||||||||
|
|
||||||||||||
|
Net loss
|
$ | (7,348,629 | ) | $ | (4,322,516 | ) | $ | (165,706,357 | ) | |||
|
Adjustments to reconcile net loss to net cash used in operating
activities:
|
||||||||||||
|
Depreciation and amortization
|
20,237 | 11,647 | 10,467,857 | |||||||||
|
(Gain) loss on disposals of fixed assets
|
(2,973 | ) | | 56,812 | ||||||||
|
Loss on fair value of warrants
|
| | 12,239,688 | |||||||||
|
(Gain) loss on change in fair value of contingent consideration
|
227,828 | | 227,828 | |||||||||
|
Expenses related to share-based compensation
|
208,642 | 451,974 | 9,432,584 | |||||||||
|
Expense related to stock options issued to non-employees
|
| | 204,664 | |||||||||
|
Expenses paid by issuance of common stock
|
| | 1,341,372 | |||||||||
|
Expenses paid by issuance of warrants
|
| | 573,357 | |||||||||
|
Expenses paid by issuance of preferred stock
|
| | 142,501 | |||||||||
|
Expenses related to stock warrants issued
|
| | 612,000 | |||||||||
|
Accretion of discount on investments in securities
|
| | (1,604,494 | ) | ||||||||
|
Amortization of debt discount
|
| | 450,000 | |||||||||
|
Forgiveness of employee receivable
|
| | 30,036 | |||||||||
|
Impairment loss write-off of goodwill
|
| | 5,702,130 | |||||||||
|
Equity in loss of investee
|
| | 178,936 | |||||||||
|
In-process research and development
|
| | 10,422,130 | |||||||||
|
Write-off of license agreement
|
| | 152,866 | |||||||||
|
Write-off of assets available-for-sale
|
| | 108,000 | |||||||||
|
Cumulative effect of change in accounting principle
|
| | 25,821 | |||||||||
|
Changes in assets and liabilities, net of effect of acquisitions:
|
||||||||||||
|
(Increase) decrease in prepaid expenses and other assets
|
(343,971 | ) | (293,076 | ) | (1,055,081 | ) | ||||||
|
Increase (decrease) in accounts payable and accrued liabilities
|
261,051 | (1,025,815 | ) | 2,239,235 | ||||||||
|
|
||||||||||||
|
Net cash used in operating activities
|
(6,977,815 | ) | (5,177,786 | ) | (113,758,115 | ) | ||||||
|
|
||||||||||||
|
|
||||||||||||
|
Cash flows from investing activities:
|
||||||||||||
|
Purchases of short-term investments
|
| | (111,183,884 | ) | ||||||||
|
Proceeds from sales and maturities of short-term investments
|
| | 112,788,378 | |||||||||
|
Purchases of property and equipment
|
(24,538 | ) | (6,780 | ) | (1,083,405 | ) | ||||||
|
Proceeds from sale of property and equipment
|
12,635 | | 66,920 | |||||||||
|
Purchase of certificate of deposit
|
| | (1,016,330 | ) | ||||||||
|
Maturity of certificate of deposit
|
| | 1,016,330 | |||||||||
|
Payment on obligation under license agreement
|
| | (106,250 | ) | ||||||||
|
Cash acquired from acquisitions, net of cash paid
|
| | 32,395 | |||||||||
|
Issuance of note receivable related party
|
| | (35,000 | ) | ||||||||
|
Payments on note receivable
|
| | 405,993 | |||||||||
|
Advance to investee
|
| | (90,475 | ) | ||||||||
|
Cash transferred in rescission of acquisition
|
| | (19,475 | ) | ||||||||
|
Cash received in rescission of acquisition
|
| | 230,000 | |||||||||
|
|
||||||||||||
|
Net cash provided by (used in) investing activities
|
(11,903 | ) | (6,780 | ) | 1,005,197 | |||||||
|
|
||||||||||||
(3)
| Inception | ||||||||||||
| (June 12, 1996) | ||||||||||||
| Six months ended June 30, | through | |||||||||||
| 2011 | 2010 | June 30, 2011 | ||||||||||
|
Cash flows from financing activities:
|
||||||||||||
|
Proceeds from sale of preferred stock
|
| 30,453,227 | 44,474,720 | |||||||||
|
Proceeds of restricted cash for preferred stock dividends
|
| 632,789 | 633,008 | |||||||||
|
Proceeds from sale of common stock
|
22,507,529 | | 106,658,871 | |||||||||
|
Proceeds from exercise of stock options
|
| | 712,367 | |||||||||
|
Proceeds from sale or exercise of warrants
|
| 317,444 | 14,714,258 | |||||||||
|
Payment to escrow for preferred stock dividends obligation
|
| (632,789 | ) | (633,008 | ) | |||||||
|
Repurchase of warrants
|
| | (55,279 | ) | ||||||||
|
Payments for financing and offering costs
|
(1,548,123 | ) | (3,093,733 | ) | (12,542,171 | ) | ||||||
|
Payments on notes payable and long-term debt
|
| | (605,909 | ) | ||||||||
|
Proceeds from issuance of notes payable and detachable warrants
|
| | 1,344,718 | |||||||||
|
Cash paid in lieu of fractional shares for reverse stock split
|
| (146 | ) | (146 | ) | |||||||
|
|
||||||||||||
|
Net cash provided by financing activities
|
20,959,406 | 27,676,792 | 154,701,429 | |||||||||
|
|
||||||||||||
|
|
||||||||||||
|
Effect of exchange rate changes on cash
|
7,466 | | 7,466 | |||||||||
|
|
||||||||||||
|
Net increase in cash and cash equivalents
|
13,977,154 | 22,492,226 | 41,955,977 | |||||||||
|
Cash and cash equivalents at beginning of period
|
27,978,823 | 8,667,404 | | |||||||||
|
|
||||||||||||
|
Cash and cash equivalents at end of period
|
$ | 41,955,977 | $ | 31,159,630 | $ | 41,955,977 | ||||||
|
|
||||||||||||
(4)
| 1. |
Basis of Presentation
|
| 2. |
Use of Estimates
|
| 3. |
Acquisition of SynthRx
|
(5)
(6)
| Probability | ||||||||
| Shares Issued / | Weighted | |||||||
| Milestone | To Be Issued | Fair Value | ||||||
|
|
||||||||
|
Initial consideration (fully vested)
|
862,078 | $ | 2,017,263 | |||||
|
Initial consideration that vests upon achievement of
First Milestone (Subject to Vesting shares)
|
1,938,773 | 2,103,375 | ||||||
|
First Milestone phase 3 clinical study first dosing
|
1,000,000 | 1,084,900 | ||||||
|
Second Milestone NDA acceptance
|
3,839,400 | 733,403 | ||||||
|
Third Milestone FDA approval
|
8,638,650 | 730,801 | ||||||
|
|
||||||||
|
|
||||||||
|
Total
|
16,278,901 | $ | 6,669,742 | |||||
|
|
||||||||
|
Net tangible assets acquired
|
$ | 18,513 | ||
|
Net tangible liabilities assumed
|
(301,566 | ) | ||
|
Acquired intangibles:
|
||||
|
In-process research and development
|
6,549,000 | |||
|
Goodwill
|
403,795 | |||
|
|
||||
|
|
||||
|
Total preliminary estimated purchase price
|
$ | 6,669,742 | ||
|
|
||||
| Three months ended June 30, | Six months ended June 30, | |||||||||||||||
| 2011 | 2010 | 2011 | 2010 | |||||||||||||
|
Revenues
|
$ | | $ | | $ | | $ | | ||||||||
|
Loss from operations
|
(3,452,757 | ) | (1,980,437 | ) | (6,123,270 | ) | (4,426,126 | ) | ||||||||
|
Net loss applicable to common stock
|
(3,438,472 | ) | (5,081,960 | ) | (6,070,993 | ) | (10,025,713 | ) | ||||||||
|
Net loss per share, basic and diluted
|
$ | ( 0.13 | ) | $ | (0.32 | ) | $ | (0.23 | ) | $ | (0.70 | ) | ||||
|
|
||||||||||||||||
| 4. |
Fair Value of Financial Instruments
|
(7)
| June 30, 2011 | ||||||||||||||||
| Total Fair | Fair Value Determined Under: | |||||||||||||||
| Value | (Level 1) | (Level 2) | (Level 3) | |||||||||||||
|
|
||||||||||||||||
|
Contingent asset
|
$ | 387,753 | $ | | $ | | $ | 387,753 | ||||||||
|
Contingent consideration
|
$ | (1,400,000 | ) | $ | | $ | | $ | (1,400,000 | ) | ||||||
| 5. |
Share-Based Compensation Expense
|
| Three months ended June 30, | Six months ended June 30, | |||||||||||||||
| 2011 | 2010 | 2011 | 2010 | |||||||||||||
|
Selling, general and administrative expense
|
$ | 133,069 | $ | 227,751 | $ | 270,245 | $ | 456,288 | ||||||||
|
Research and development expense
|
(59,745 | ) | (1,267 | ) | (61,603 | ) | (4,314 | ) | ||||||||
|
|
||||||||||||||||
|
Share-based compensation expense before taxes
|
73,324 | 226,484 | 208,642 | 451,974 | ||||||||||||
|
Related income tax benefits
|
| | | | ||||||||||||
|
|
||||||||||||||||
|
|
||||||||||||||||
|
Share-based compensation expense
|
$ | 73,324 | $ | 226,484 | $ | 208,642 | $ | 451,974 | ||||||||
|
|
||||||||||||||||
|
|
||||||||||||||||
|
Net share-based compensation expense per
common share basic and diluted
|
$ | 0.00 | $ | 0.02 | $ | 0.01 | $ | 0.04 | ||||||||
|
|
||||||||||||||||
| 6. |
Comprehensive Loss
|
(8)
| 7. |
Net Loss Per Common Share
|
| June 30, | ||||||||
| 2011 | 2010 | |||||||
|
Options
|
809,525 | 433,737 | ||||||
|
Warrants
|
7,777,988 | 4,055,030 | ||||||
|
Convertible preferred stock
|
| 779,092 | ||||||
|
|
||||||||
|
|
8,587,513 | 5,267,859 | ||||||
|
|
||||||||
| 8. |
Recent Accounting Pronouncements
|
| 9. |
Grant Revenue
|
(9)
| 10. |
Supplementary Cash Flow Information
|
| Inception | ||||||||||||
| (June 12, 1996) | ||||||||||||
| Six months ended June 30, | through | |||||||||||
| 2011 | 2010 | June 30, 2011 | ||||||||||
|
Supplemental disclosures of cash flow information
|
||||||||||||
|
Interest paid
|
$ | | $ | 1,629 | $ | 180,719 | ||||||
|
Supplemental disclosures of non-cash investing and financing
activities:
|
||||||||||||
|
Issuance of warrants, common stock and preferred stock for:
|
||||||||||||
|
Conversion of notes payable and accrued interest
|
| | 1,213,988 | |||||||||
|
Prepaid services to consultants
|
| | 1,482,781 | |||||||||
|
Conversion of preferred stock
|
| 54,260 | 13,674 | |||||||||
|
Acquisitions
|
5,885,323 | | 30,666,878 | |||||||||
|
Payment of dividends
|
| | 213,000 | |||||||||
|
Financial advisor services in connection with private placements
|
1,061,910 | 724,286 | 3,615,464 | |||||||||
|
Acquisition of treasury stock in settlement of a claim
|
| | 34,747 | |||||||||
|
Cancellation of treasury stock
|
| | (34,747 | ) | ||||||||
|
Assumptions of liabilities in acquisitions
|
301,566 | | 1,537,473 | |||||||||
|
Fair value of contingent liabilities, net of contingent assets,
recorded due to acquisition
|
784,419 | | 784,419 | |||||||||
|
Acquisition of license agreement for long-term debt
|
| | 161,180 | |||||||||
|
Cashless exercise of warrants
|
| | 4,312 | |||||||||
|
Dividends accrued
|
| | 621,040 | |||||||||
|
Trade asset converted to available-for-sale asset
|
| | 108,000 | |||||||||
|
Dividends extinguished
|
| | 408,240 | |||||||||
|
Trade payable converted to note payable
|
| | 83,948 | |||||||||
|
Issuance of warrants for return of common stock
|
| | 50,852 | |||||||||
|
Detachable warrants issued with notes payable
|
| | 450,000 | |||||||||
|
Cumulative preferred stock dividends
|
| 7,131,114 | 13,502,403 | |||||||||
| 11. |
Stockholders Equity
|
(10)
| Warrants | Exercise Price | Expiration Date | ||||||||||
|
|
||||||||||||
| 432,429 |
|
$ | 56.5000 | July 2012 | ||||||||
| 36,071 |
|
$ | 3.7500 | June 2014 | ||||||||
| 19,007 |
|
$ | 4.4750 | July 2014 | ||||||||
| 14,183 |
|
$ | 4.0625 | August 2014 | ||||||||
| 216,000 |
|
$ | 3.6700 | October 2014 | ||||||||
| 144,000 |
|
$ | 5.8750 | October 2014 | ||||||||
| 498,488 |
|
$ | 8.7475 | July 2012 | ||||||||
| 99,696 |
|
$ | 11.9125 | June 2014 | ||||||||
| 1,816,608 |
|
$ | 3.6500 | May 2015 | ||||||||
| 2,046,139 |
|
$ | 2.7500 | January 2012 | ||||||||
| 2,046,139 |
|
$ | 2.7500 | January 2016 | ||||||||
| 409,228 |
|
$ | 3.4400 | April 2015 | ||||||||
|
|
||||||||||||
| 7,777,988 |
|
|||||||||||
|
|
||||||||||||
(11)
(12)
(13)
(14)
| |
the number of trials necessary to demonstrate the safety and efficacy of a product
candidate;
|
| |
the number of patients who participate in the trials;
|
| |
the number and location of sites included in trials and the rate of site approval for
the trial;
|
| |
the rates of patient recruitment and enrollment;
|
| |
the ratio of randomized to evaluable patients;
|
| |
the time and cost of process development activities related to our product
candidates;
|
| |
the costs of manufacturing our product candidates;
|
| |
with respect to bioequivalence or comparative trials, the availability and cost of
reference or control product in the jurisdiction of each site;
|
(15)
| |
the duration of patient treatment and follow-up;
|
| |
the time and cost of stability studies, including the need to identify critical
parameters, methods to evaluate and test these parameters and validation of such methods
and tests; and
|
| |
the costs, requirements, timing of and the ability to secure regulatory approvals.
|
| January 1, 2005 | ||||||||||||
| through | ||||||||||||
| Three months ended June 30, | June 30, | |||||||||||
| 2011 | 2010 | 2011 | ||||||||||
|
External bioequivalence and clinical trial fees and expenses
|
$ | 232,859 | $ | 18,338 | $ | 24,341,154 | ||||||
|
External nonclinical study fees and expenses (1)
|
1,017,404 | 558,175 | 28,725,684 | |||||||||
|
Personnel costs
|
152,055 | 58,520 | 10,765,360 | |||||||||
|
Share-based compensation expense
|
(59,745 | ) | (1,267 | ) | 2,858,382 | |||||||
|
|
||||||||||||
|
Total
|
$ | 1,342,573 | $ | 633,766 | $ | 66,690,580 | ||||||
|
|
||||||||||||
| (1) |
External nonclinical study fees and expenses include preclinical, research-related
manufacturing, quality assurance and regulatory expenses.
|
(16)
| Six months ended June 30, | ||||||||
| 2011 | 2010 | |||||||
|
External bioequivalence and clinical trial fees and expenses
|
$ | 323,092 | $ | 46,111 | ||||
|
External nonclinical study fees and expenses (1)
|
1,471,013 | 1,740,260 | ||||||
|
Personnel costs
|
221,364 | 91,038 | ||||||
|
Share-based compensation expense
|
(61,603 | ) | (4,314 | ) | ||||
|
|
||||||||
|
Total
|
$ | 1,953,866 | $ | 1,873,095 | ||||
|
|
||||||||
| (1) |
External nonclinical study fees and expenses include preclinical, research-related
manufacturing, quality assurance and regulatory expenses.
|
(17)
(18)
(19)
| |
the extent to which we acquire new technologies, product candidates, products or
businesses and our ability to integrate them, including the assets we recently acquired
from SynthRx, Inc., successfully into our operations;
|
| |
our ability, or that of a future partner, to successfully develop and obtain
regulatory approval for our product candidates and, if approved, to successfully
commercialize them in the U.S. and/or elsewhere;
|
(20)
| |
our ability to obtain stockholder approval to complete other product pipeline
expansion transactions, if necessary, on a timely basis, or at all;
|
| |
the potential that we may enter into a merger or other business combination whereby
the stockholders who own the majority of our voting securities prior to the transaction
own less than a majority after the transaction;
|
| |
the potential that we may enter into one or more commercial partnerships or other
strategic transactions relating to our product candidates, and the terms of any such
transactions;
|
| |
our ability to obtain additional funding to develop and commercialize our current
product candidates and any product candidates or products we may acquire in the future,
on a timely basis or on acceptable terms, or at all;
|
| |
the extent to which we rebuild our workforce and our ability to attract and retain
qualified personnel and manage growth;
|
| |
delays in the commencement or completion of nonclinical testing, bioequivalence or
clinical trials of or manufacturing, regulatory or launch activities related to our
product candidates;
|
| |
the success of future clinical or bioequivalence trials;
|
| |
our ability to develop or acquire sales, marketing and distribution capabilities to
commercialize any of our product candidates for which we obtain regulatory approval;
|
| |
whether any of our product candidates for which we receive regulatory approval, if
any, achieve broad market acceptance;
|
| |
our ability to maintain our relationships with the single source manufacturers and
suppliers for certain of our product candidates and their component materials and the
ability of such manufacturers and suppliers to successfully and consistently manufacture
and supply, as applicable, our products and their component materials on a commercial
scale, if we receive regulatory approval to commercialize our product candidates;
|
| |
the satisfactory performance of third parties on whom we rely significantly to
conduct our nonclinical testing and bioequivalence and clinical studies and other
aspects of our development programs;
|
| |
undesirable side effects that our product candidates may cause;
|
| |
our ability to protect our intellectual rights with respect to our product candidates
and proprietary technology;
|
| |
claims against us for infringing the proprietary rights of third parties;
|
| |
competition in the marketplace for our products, if any are approved;
|
| |
healthcare reform measures and reimbursement policies that, if not favorable to our
products, could hinder or prevent our products commercial success;
|
| |
potential product liability exposure and, if successful claims are brought against
us, liability for a product or product candidate;
|
| |
our ability to maintain compliance with NYSE Amex continued listing standards and
maintain the listing of our common stock on the NYSE Amex or another national securities
exchange; and
|
| |
the other factors that are described in the section entitled Risk Factors, in Item
1A of Part I of our annual report on Form 10-K for the year ended December 31, 2010.
|
(21)
(22)
|
ADVENTRX Pharmaceuticals, Inc.
|
||||
| Date: August 8, 2011 | By: | /s/ Brian M. Culley | ||
| Brian M. Culley | ||||
|
Chief Executive Officer
(Principal Executive Officer) |
||||
| By: | /s/ Patrick L. Keran | |||
| Patrick L. Keran | ||||
|
President and Chief Operating Officer
(Principal Financial Officer) |
||||
(23)
| Exhibit | Description | ||
|
|
|||
|
2.1
|
(1) | Agreement and Plan of Merger, dated February 12, 2011, by and among the registrant, SRX Acquisition Corporation, SynthRx, Inc. and, solely with respect to Sections 2 and 8, the Stockholders Agent. | |
|
|
|||
|
10.1
|
(1) | Stockholders Voting and Transfer Restriction Agreement, dated February 12, 2011, by and among the registrant, each of the principal stockholders of SynthRx, Inc. and, solely with respect to Section 3(c), the Stockholders Agent. | |
|
|
|||
|
10.2
|
(1) | License Agreement, dated June 8, 2004, between SynthRx, Inc. and CytRx Corporation, as amended by that certain Letter Agreement Re: Amendment to License Agreement, dated August 3, 2006, and that certain Agreement and Amendment No. 2 to License Agreement, dated December 1, 2010. | |
|
|
|||
|
10.3
|
(2) # | ADVENTRX Pharmaceuticals, Inc. Amended and Restated 2008 Omnibus Incentive Plan. | |
|
|
|||
|
10.4
|
(2) # | Form of [Non-Statutory][Incentive] Stock Option Grant Agreement (for consultants/employees) under the Amended and Restated 2008 Omnibus Incentive Plan. | |
|
|
|||
|
10.5
|
(2) # | Form of Non-Statutory Stock Option Grant Agreement Director under the Amended and Restated 2008 Omnibus Incentive Plan. | |
|
|
|||
|
31.1
|
Certification of principal executive officer pursuant to Rules 13a-14(a)/15d-14(a). | ||
|
|
|||
|
31.2
|
Certification of principal financial officer pursuant to Rules 13a-14(a)/15d-14(a). | ||
|
|
|||
|
32.1
|
* | Certification of principal executive officer and principal financial officer pursuant to 18 U.S.C. 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.DEF
|
** | XBRL Taxonomy Extension Definition Linkbase Document | |
|
|
|||
|
101.LAB
|
** | XBRL Taxonomy Extension Label Linkbase Document | |
|
|
|||
|
101.PRE
|
** | XBRL Taxonomy Extension Presentation Linkbase Document | |
| |
Indicates that confidential treatment has been requested or granted to certain
portions, which portions have been omitted and filed separately with the SEC.
|
|
| # |
Indicates management contract or compensatory plan.
|
|
| * |
This certification is being furnished solely to accompany this report pursuant to
18 U.S.C. 1350, and is not being filed for purposes of Section 18 of the
Securities Exchange Act of 1934 and is not to be incorporated by reference into
any filing of the registrant, whether made before or after the date hereof,
regardless of any general incorporation language in such filing.
|
|
| ** |
Pursuant to Rule 406T of regulation S-T, the Interactive Data Files on Exhibit 101 hereto are deemed not filed or part
of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, as amended, are deemed
not filed for purposes of Section 18 of the Securities and Exchange Act of 1934, as amended, and otherwise are not
subject to liability under those sections.
|
|
| (1) |
Filed with the registrants Current Report on Form 8-K on April 11, 2011 (SEC file
number 001-32157-11752769).
|
|
| (2) |
Filed with the registrants Form S-8 Registration Statement on June 16, 2011 (SEC
file number 333-174940-11914946).
|
No information found
* THE VALUE IS THE MARKET VALUE AS OF THE LAST DAY OF THE QUARTER FOR WHICH THE 13F WAS FILED.
| FUND | NUMBER OF SHARES | VALUE ($) | PUT OR CALL |
|---|
| DIRECTORS | AGE | BIO | OTHER DIRECTOR MEMBERSHIPS |
|---|
No information found
No Customers Found
No Suppliers Found
Price
Yield
| Owner | Position | Direct Shares | Indirect Shares |
|---|