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x
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Annual Report Under Section 13 Or 15(d) Of The Securities Exchange Act Of 1934
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For the fiscal year ended
December 31, 2012
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or
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o
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Transition Report Under Section 13 Or 15(d) Of The Securities Exchange Act Of 1934
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For the transition period from _____to _____
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Nevada
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000-52446
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(State or other jurisdiction of organization)
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(IRS Employer Identification #)
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Large accelerated filer
o
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Accelerated filer
o
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Non-accelerated filer
o
(Do not check if a smaller reporting company)
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Smaller reporting company
x
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Page
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PART I
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Item 1.
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3
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Item 1A.
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11
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Item 1B.
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28
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Item 2.
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28
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Item 3.
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28
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Item 4.
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28
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PART II
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Item 5.
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29
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Item 6.
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30
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Item 7.
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30
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Item 7A.
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37
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Item 8.
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38
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Item 9.
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39
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Item 9A.
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39
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Item 9B.
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40
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PART III
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||
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Item 10.
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41
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Item 11.
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46
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Item 12.
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49
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Item 13.
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51
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Item 14.
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54
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PART IV
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||
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Item 15.
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55
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Signature Page
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57
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●
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Two clinical-stage products, Iomab-B and Actimab-A, in development for blood borne cancers;
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●
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Preclinical data in additional cancer indications;
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●
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A proprietary technology platform for novel radioimmunotherapy cancer treatments; and
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●
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A proprietary process for manufacturing of the alpha particle emitting radioactive isotope actinium 225 (Ac-225).
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●
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In-licensing a Phase II clinical stage monoclonal antibody, BC8, with safety and efficacy data in more than 250 patients in need of Hematopoietic Stem Cell Transplantation (HSCT), currently in 7 active Phase I and Phase II clinical trials;
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●
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Commencing a Company sponsored multi-center Phase I/II clinical trial for Actimab-A in elderly Acute Myeloid Leukemia;
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●
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Developing and organizing manufacturing of Actinium’s lead drug candidate Actimab-A which was accepted by the FDA for multi-center human use;
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●
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Supporting three physician sponsored clinical trials, including a Phase I and a Phase I/II trial with the alpha emitting radioactive isotope bismuth 213 (Bi-213) based AML drug and a Phase I clinical trial with the alpha emitting radioactive isotope actinium 225 (Ac-225) based AML drug;
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●
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In-licensing the AML targeting monoclonal antibody known as HuM195 or Lintuzumab;
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●
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Establishing clinical and preclinical development relationships with world-class institutions such as MSKCC, Fred Hutchinson Cancer Research Center (FHCRC) and University of Texas MD Anderson Cancer Center (the MD Anderson Cancer Center relationship includes clinical trials only), as well as leading clinical experts in the fields of AML and HSCT;
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●
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Securing rights to an intellectual property estate that covers key aspects of the Company’s proprietary technology platform;
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●
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Supporting a number of pipeline projects, including preclinical experiments in metastatic prostate cancer, metastatic colon cancer, antiangiogenesis and breast cancer models;
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●
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Maintaining contractual relationship with Oak Ridge National Laboratory (ORNL) of the Department of Energy (DOE) which gives API access to most of the current world supply of Ac-225; and
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●
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Successfully developing commercial production methods for actinium 225.
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●
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Clinical results to date imply lower development risk for its lead drug candidates:
The Company’s lead drug candidates have been tested in over 300 patients and demonstrated favorable safety and efficacy profiles. Iomab™-B has been administered to more than 250 patients in a number of Phase I and Phase II trials and has shown a clear survival benefit in the indication for which it is being developed. Bismab®-A and Actimab™-A, drugs based on the APIT platform have so far been tested in over 60 patients in 3 clinical trials. In each trial they exhibited few side effects and have shown indications of efficacy. The current proof-of-concept Actimab™-A Phase I/II clinical trial is directed at a patient population that is generally easier to treat (newly diagnosed vs. relapsed/refractory in previous trials), and employs a more potent treatment regimen (low dose chemotherapy plus two doses of ActimabTM-A plus low dose chemotherapy vs. a single dose of ActimabTM-A in the physician sponsored trial).
|
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●
|
Additional product opportunities from the APIT platform:
The Company’s Alpha Particle Immunotherapy technology has the potential for broad applicability for the treatment of many cancer types, which allows the Company to add new product candidates to its pipeline based on well-defined patent protected methods. The next product from the platform is expected to be a second generation BC8 product linked to Ac-225, Actimab™-B which could potentially significantly expand the market that is targeted by Iomab™-B.
|
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●
|
Collaboration with Memorial Sloan-Kettering Cancer Center (MSKCC):
The Company’s collaboration with MSKCC includes licensing, research and clinical trial arrangements involving MSKCC labs and clinicians and included financial support with respect to certain pre-2012 R&D-related expenses.
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●
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Scientific backing of leading experts:
The Company’s clinical advisory board and collaborators include some of the best recognized clinicians and scientists working at some of the highest regarded medical institutions in the U.S. and the world, including MSKCC, Johns Hopkins University, University of Pennsylvania, Fred Hutchinson Cancer Center and MD Anderson Cancer Center. This is expected to be beneficial to the Company both in clinical development and market acceptance assuming its drug candidates are approved.
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●
|
Isotope supply secured for clinical trials:
The Company has a contractual relationship with ORNL (Oak Ridge National Laboratory of the Department of Energy (DOE)) that provides the Company access to the largest known supply reserves of actinium 225. Iodine 131 is readily available from a number of qualified pharmaceutical supply vendors.
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●
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Proprietary alpha emitting isotope manufacturing technology fully developed:
The Company has developed its own proprietary technology for commercial scale manufacturing of actinium 225. This is expected to ensure commercial supply of Ac-225 for Actimab™-A, Actimab™-B and other actinium-linked products should they be approved.
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●
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cGMP Actimab™-A manufacturing developed:
The Company has developed at a contractor’s site full cGMP (current good manufacturing practices) manufacturing processes for its drug candidate Actimab™-A.
|
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●
|
Substantial IP portfolio:
The Company has an intellectual property portfolio in excess of 60 patents and patent applications, both in the U.S. and other countries, which cover clinical applications of the APIT technology and methods of manufacturing actinium 225 thus giving the Company control over both the applications of its technology and a supply chain of its key ingredients, actinium 225 and bismuth 213 alpha emitting isotopes.
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●
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actual or anticipated variations in our operating results;
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●
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announcements of developments by us or our competitors;
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●
|
the timing of IND and/or NDA approval, the completion and/or results of our clinical trials;
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●
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regulatory actions regarding our products;
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●
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announcements by us or our competitors of significant acquisitions, strategic partnerships, joint ventures or capital commitments;
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●
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adoption of new accounting standards affecting the our industry;
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●
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additions or departures of key personnel;
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●
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introduction of new products by us or our competitors;
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●
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sales of the our Common Stock or other securities in the open market; and
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●
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other events or factors, many of which are beyond our control.
|
|
For the Years ended
December 31,
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Increase
|
|||||||||||
|
2012
|
2011
|
(Decrease)
|
||||||||||
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Revenues
|
$
|
-
|
$
|
-
|
$
|
-
|
||||||
|
Operating expenses:
|
||||||||||||
|
Research and development, net of reimbursements
|
3,440,485
|
323,788
|
3,116,697
|
|||||||||
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General and administrative
|
4,506,232
|
2,959,246
|
1,546,986
|
|||||||||
|
Depreciation expense
|
581
|
633
|
(52
|
)
|
||||||||
|
Total operating expenses
|
7,947,298
|
3,283,667
|
4,633,631
|
|||||||||
|
Other (income) expense:
|
||||||||||||
|
Interest expense
|
1,099,327
|
175,094
|
924,233
|
|||||||||
|
Gain on change in fair value of derivative liabilities
|
(685,420
|
)
|
(13,966
|
)
|
(671,454
|
) | ||||||
|
Total other (income) expense
|
413,907
|
161,128
|
252,779
|
|||||||||
|
Net loss
|
$
|
(8,361,205
|
)
|
$
|
(3,444,795
|
)
|
$
|
(4,916,410
|
)
|
|||
|
For the years ended
December 31,
|
||||||||
|
2012
|
2011
|
|||||||
|
Cash provided by (used in) operating activities
|
$
|
(5,212,710
|
)
|
$
|
(517,592
|
)
|
||
|
Cash provided by (used in) investing activities
|
(2,359
|
)
|
-
|
|||||
|
Cash provided by (used in) financing activities
|
5,129,940
|
6,025,255
|
||||||
|
Net increase (decrease) in cash
|
$
|
(85,129
|
)
|
$
|
5,507,663
|
|||
|
December 31,
2012
|
December 31,
2011
|
|||||||
|
ASSETS
|
||||||||
|
Current assets:
|
||||||||
|
Cash
|
$
|
5,618,669
|
$
|
5,703,798
|
||||
|
R&D reimbursement receivable
|
-
|
237,834
|
||||||
|
Prepaid expenses and other current assets
|
167,143
|
5,384
|
||||||
|
Deferred financing costs, net of accumulated amortization
|
-
|
252,248
|
||||||
|
Total current assets
|
5,785,812
|
6,199,264
|
||||||
|
Property and equipment, net of accumulated depreciation
|
3,010
|
1,233
|
||||||
|
TOTAL ASSETS
|
$
|
5,788,822
|
$
|
6,200,497
|
||||
|
LIABILITIES AND STOCKHOLDERS' EQUITY
|
||||||||
|
Current liabilities:
|
||||||||
|
Accounts payable and accrued expenses
|
$
|
897,044
|
$
|
644,511
|
||||
|
Accounts payable and accrued expenses – related party
|
31,185
|
-
|
||||||
|
Note payable
|
140,000
|
-
|
||||||
|
Convertible notes payable, net of unamortized discount
|
-
|
124,363
|
||||||
|
Derivative liabilities
|
3,574,958
|
4,439,613
|
||||||
|
Total current liabilities
|
4,643,187
|
5,208,487
|
||||||
|
Commitments and contingencies
|
||||||||
|
Stockholders’ equity:
|
||||||||
|
Preferred stock, $0.01 par value; 100,000,000 shares authorized;
|
||||||||
|
0 shares issued and outstanding
|
-
|
-
|
||||||
|
Common stock, $0.01 par value, 100,000,000 shares authorized;
|
||||||||
|
21,391,665 and 13,664,802 shares issued and outstanding, respectively
|
213,916
|
136,648
|
||||||
|
Additional paid-in capital
|
56,675,182
|
48,237,620
|
||||||
|
Deficit accumulated during the development stage
|
(55,743,463
|
)
|
(47,382,258
|
)
|
||||
|
Total stockholders' equity
|
1,145,635
|
992,010
|
||||||
|
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY
|
$
|
5,788,822
|
$
|
6,200,497
|
||||
|
For the Period
|
||||||||||||
|
For the Years Ended
|
from June 13,
2000
(Inception) to
|
|||||||||||
|
December 31,
|
December 31,
|
|||||||||||
|
2012
|
2011
|
2012
|
||||||||||
|
Revenues
|
$
|
-
|
$
|
-
|
$
|
-
|
||||||
|
Operating expenses:
|
||||||||||||
|
Research and development, net of reimbursements
|
3,440,485
|
323,788
|
26,420,519
|
|||||||||
|
General and administrative
|
4,506,232
|
2,959,246
|
24,504,975
|
|||||||||
|
Depreciation and amortization expense
|
581
|
633
|
3,262,462
|
|||||||||
|
Loss on disposition of equipment
|
-
|
-
|
550,186
|
|||||||||
|
Total operating expenses
|
7,947,298
|
3,283,667
|
54,738,142
|
|||||||||
|
Loss from operations
|
(7,947,298
|
)
|
(3,283,667
|
)
|
(54,738,142
|
)
|
||||||
|
Other (income) expense:
|
||||||||||||
|
Interest expense
|
1,099,327
|
175,094
|
1,964,707
|
|||||||||
|
Gain on extinguishment of liability
|
-
|
-
|
(260,000
|
)
|
||||||||
|
Gain on change in fair value of derivative liabilities
|
(685,420
|
)
|
(13,966
|
)
|
(699,386
|
)
|
||||||
|
Total other (income) expense
|
413,907
|
161,128
|
1,005,321
|
|||||||||
|
Net loss
|
$
|
(8,361,205
|
)
|
$
|
(3,444,795
|
)
|
$
|
(55,743,463
|
)
|
|||
|
Net loss per common share - basic and diluted
|
$
|
(7.58
|
)
|
$
|
(4.30
|
)
|
||||||
|
Weighted average number of common shares
|
||||||||||||
|
outstanding - basic and diluted
|
1,103,521
|
801,799
|
||||||||||
|
Deficit
|
||||||||||||||||||||
|
Accumulated
|
||||||||||||||||||||
|
Additional
|
During the
|
Total
|
||||||||||||||||||
|
Common Stock
|
Paid-in
|
Development
|
Stockholders'
|
|||||||||||||||||
|
Shares
|
Amount
|
Capital
|
Stage
|
Equity (Deficit)
|
||||||||||||||||
|
Issuance of founder shares
|
999,000
|
$
|
9,990
|
$
|
20,010
|
$
|
-
|
$
|
30,000
|
|||||||||||
|
Proceeds from issuance of stock
|
145,687
|
1,457
|
1,748,543
|
-
|
1,750,000
|
|||||||||||||||
|
Net loss
|
-
|
-
|
-
|
(672,286
|
)
|
(672,286
|
)
|
|||||||||||||
|
Balances, December 31, 2000
|
1,144,687
|
11,447
|
1,768,553
|
(672,286
|
)
|
1,107,714
|
||||||||||||||
|
Proceeds from issuance of stock
|
187,313
|
1,873
|
2,248,127
|
-
|
2,250,000
|
|||||||||||||||
|
Net loss
|
-
|
-
|
-
|
(5,090,621
|
)
|
(5,090,621
|
)
|
|||||||||||||
|
Balances, December 31, 2001
|
1,332,000
|
13,320
|
4,016,680
|
(5,762,907
|
)
|
(1,732,907
|
)
|
|||||||||||||
|
Proceeds from issuance of stock
|
180,375
|
1,804
|
3,248,196
|
-
|
3,250,000
|
|||||||||||||||
|
Net loss
|
-
|
-
|
-
|
(3,192,384
|
)
|
(3,192,384
|
)
|
|||||||||||||
|
Balances, December 31, 2002
|
1,512,375
|
15,124
|
7,264,876
|
(8,955,291
|
)
|
(1,675,291
|
)
|
|||||||||||||
|
Proceeds from issuance of stock
|
208,992
|
2,090
|
6,779,160
|
-
|
6,781,250
|
|||||||||||||||
|
Net loss
|
-
|
-
|
-
|
(3,532,044
|
)
|
(3,532,044
|
)
|
|||||||||||||
|
Balances, December 31, 2003
|
1,721,367
|
17,214
|
14,044,036
|
(12,487,335
|
)
|
1,573,915
|
||||||||||||||
|
Proceeds from issuance of stock
|
765,900
|
7,659
|
4,592,341
|
-
|
4,600,000
|
|||||||||||||||
|
Net loss
|
-
|
-
|
-
|
(5,734,791
|
)
|
(5,734,791
|
)
|
|||||||||||||
|
Balances, December 31, 2004
|
2,487,267
|
24,873
|
18,636,377
|
(18,222,126
|
)
|
439,124
|
||||||||||||||
|
Proceeds from issuance of stock
|
649,350
|
6,494
|
3,893,506
|
-
|
3,900,000
|
|||||||||||||||
|
Option expense
|
-
|
-
|
315,388
|
-
|
315,388
|
|||||||||||||||
|
Net loss
|
-
|
-
|
-
|
(4,580,237
|
)
|
(4,580,237
|
)
|
|||||||||||||
|
Balances, December 31, 2005
|
3,136,617
|
$
|
31,367
|
$
|
22,845,271
|
$
|
(22,802,363
|
)
|
$
|
74,275
|
||||||||||
|
(Continued)
|
Deficit
|
|||||||||||||||||||
|
Accumulated
|
||||||||||||||||||||
|
Additional
|
During the
|
Total
|
||||||||||||||||||
|
Common Stock
|
Paid-in
|
Development
|
Stockholders'
|
|||||||||||||||||
|
Shares
|
Amount
|
Capital
|
Stage
|
Equity (Deficit)
|
||||||||||||||||
|
Balances, December 31, 2005
|
3,136,617
|
$
|
31,367
|
$
|
22,845,271
|
$
|
(22,802,363
|
)
|
$
|
74,275
|
||||||||||
|
Proceeds from issuance of stock
|
839,042
|
8,390
|
7,542,151
|
-
|
7,550,541
|
|||||||||||||||
|
Option expense
|
-
|
-
|
252,308
|
-
|
252,308
|
|||||||||||||||
|
Net loss
|
-
|
-
|
-
|
(6,053,362
|
)
|
(6,053,362
|
)
|
|||||||||||||
|
Balances, December 31, 2006
|
3,975,659
|
39,757
|
30,639,730
|
(28,855,725
|
)
|
1,823,762
|
||||||||||||||
|
Proceeds from issuance of stock
|
732,600
|
7,326
|
6,592,674
|
-
|
6,600,000
|
|||||||||||||||
|
Common stock issued for services
|
66,402
|
664
|
398,146
|
-
|
398,810
|
|||||||||||||||
|
Option expense
|
-
|
-
|
255,061
|
-
|
255,061
|
|||||||||||||||
|
Net loss
|
-
|
-
|
-
|
(5,617,581
|
)
|
(5,617,581
|
)
|
|||||||||||||
|
Balances, December 31, 2007
|
4,774,661
|
47,747
|
37,885,611
|
(34,473,306
|
)
|
3,460,052
|
||||||||||||||
|
Proceeds from issuance of stock
|
999,000
|
9,990
|
5,990,010
|
-
|
6,000,000
|
|||||||||||||||
|
Option expense
|
-
|
-
|
269,618
|
-
|
269,618
|
|||||||||||||||
|
Net loss
|
-
|
-
|
-
|
(5,570,905
|
)
|
(5,570,905
|
)
|
|||||||||||||
|
Balances, December 31, 2008
|
5,773,661
|
57,737
|
44,145,239
|
(40,044,211
|
)
|
4,158,765
|
||||||||||||||
|
Option expense
|
-
|
-
|
112,382
|
-
|
112,382
|
|||||||||||||||
|
Net loss
|
-
|
-
|
-
|
(3,425,986
|
)
|
(3,425,986
|
)
|
|||||||||||||
|
Balances, December 31, 2009
|
5,773,661
|
57,737
|
44,257,621
|
(43,470,197
|
)
|
845,161
|
||||||||||||||
|
Option expense
|
-
|
-
|
21,166
|
-
|
21,166
|
|||||||||||||||
|
Net loss
|
-
|
-
|
-
|
(467,266
|
)
|
(467,266
|
)
|
|||||||||||||
|
Balances, December 31, 2010
|
5,773,661
|
$
|
57,737
|
$
|
44,278,787
|
$
|
(43,937,463
|
)
|
$
|
399,061
|
||||||||||
|
(Continued)
|
Deficit
|
|||||||||||||||||||
|
Accumulated
|
||||||||||||||||||||
|
Additional
|
During the
|
Total
|
||||||||||||||||||
|
Common Stock
|
Paid-in
|
Development
|
Stockholders'
|
|||||||||||||||||
|
Shares
|
Amount
|
Capital
|
Stage
|
Equity (Deficit)
|
||||||||||||||||
|
Balances, December 31, 2010
|
5,773,661
|
$
|
57,737
|
$
|
44,278,787
|
$
|
(43,937,463
|
)
|
$
|
399,061
|
||||||||||
|
Proceeds from issuance of stock
|
7,891,141
|
78,911
|
5,300,456
|
-
|
5,379,367
|
|||||||||||||||
|
Option expense
|
-
|
-
|
19,935
|
-
|
19,935
|
|||||||||||||||
|
Warrant expense
|
-
|
-
|
2,153,442
|
-
|
2,153,442
|
|||||||||||||||
|
Fair value of derivative warrants
|
-
|
-
|
(3,887,850
|
)
|
-
|
(3,887,850
|
)
|
|||||||||||||
|
Beneficial conversion feature discount
|
-
|
-
|
372,850
|
-
|
372,850
|
|||||||||||||||
|
Net loss
|
-
|
-
|
-
|
(3,444,795
|
)
|
(3,444,795
|
)
|
|||||||||||||
|
Balances, December 31, 2011
|
13,664,802
|
136,648
|
$
|
48,237,620
|
$
|
(47,382,258
|
)
|
$
|
992,010
|
|||||||||||
|
Proceeds from issuance of stock
|
4,087,747
|
40,877
|
5,089,063
|
5,129,940
|
||||||||||||||||
|
Conversion of notes payable and accrued interest to stock
|
1,252,550
|
12,525
|
969,204
|
981,729
|
||||||||||||||||
|
Shares issued at the reverse merger
|
2,386,566
|
23,866
|
(23,866
|
)
|
-
|
|||||||||||||||
|
Option expense
|
-
|
-
|
266,172
|
-
|
266,172
|
|||||||||||||||
|
Warrant expense
|
-
|
-
|
1,957,754
|
-
|
1,957,754
|
|||||||||||||||
|
Fair value of derivative warrants
|
-
|
-
|
(4,052,089
|
)
|
-
|
(4,052,089
|
)
|
|||||||||||||
|
Transfer from liability classification to equity classification
|
-
|
-
|
4,231,324
|
-
|
4,231,324
|
|||||||||||||||
|
Net loss
|
-
|
-
|
-
|
(8,361,205
|
)
|
(8,361,205
|
)
|
|||||||||||||
|
Balances, December 31, 2012
|
21,391,665
|
$
|
213,916
|
$
|
56,675,182
|
$
|
(55,743,463
|
)
|
$
|
1,145,635
|
||||||||||
|
For the Period
|
||||||||||||
|
For the Year Ended
|
from June 13,
2000 (Inception) to
|
|||||||||||
|
December 31,
|
December 31,
|
|||||||||||
|
2012
|
2011
|
2012
|
||||||||||
|
CASH FLOWS FROM OPERATING ACTIVITIES:
|
||||||||||||
|
Net loss
|
$
|
(8,361,205
|
)
|
$
|
(3,444,795
|
)
|
$
|
(55,743,463
|
)
|
|||
|
Adjustments to reconcile net loss to net cash
|
||||||||||||
|
used in operating activities:
|
||||||||||||
|
Stock-based compensation expense
|
2,223,926
|
2,173,377
|
6,052,036
|
|||||||||
|
Depreciation expense
|
581
|
633
|
3,262,462
|
|||||||||
|
Loss on disposition of equipment
|
-
|
-
|
550,186
|
|||||||||
|
Amortization of debt discount
|
775,637
|
124,363
|
900,000
|
|||||||||
|
Amortization of deferred financing costs
|
252,248
|
40,444
|
292,692
|
|||||||||
|
Gain on extinguishment of liability
|
-
|
-
|
(260,000
|
)
|
||||||||
|
Gain on change in fair value of derivative liabilities
|
(685,420
|
)
|
(13,966
|
)
|
(699,386
|
)
|
||||||
|
Changes in operating assets and liabilities:
|
||||||||||||
|
R&D reimbursement receivable
|
234,088
|
41,567
|
(3,746
|
)
|
||||||||
|
Prepaid expenses and other current assets
|
(18,013
|
)
|
4,766
|
(23,397
|
)
|
|||||||
|
Accounts payable and accrued expenses
|
334,263
|
556,019
|
1,238,773
|
|||||||||
|
Accounts payable and accrued expenses - related parties
|
31,185
|
-
|
31,185
|
|||||||||
|
Net cash used in operating activities
|
(5,212,710
|
)
|
(517,592
|
)
|
(44,402,658
|
)
|
||||||
|
CASH FLOWS FROM INVESTING ACTIVITIES:
|
||||||||||||
|
Payment made for patent rights
|
-
|
-
|
(3,000,000
|
)
|
||||||||
|
Purchases of property and equipment
|
(2,359
|
)
|
-
|
(815,659
|
)
|
|||||||
|
Net cash used in investing activities
|
(2,359
|
)
|
-
|
(3,815,659
|
)
|
|||||||
|
CASH FLOWS FROM FINANCING ACTIVITIES:
|
||||||||||||
|
Borrowings on convertible debt, net of offering costs
|
-
|
645,888
|
645,888
|
|||||||||
|
Sales of stock, net of offering costs
|
5,129,940
|
5,379,367
|
53,191,098
|
|||||||||
|
Net cash provided by financing activities
|
5,129,940
|
6,025,255
|
53,836,986
|
|||||||||
|
Net increase (decrease) in cash
|
(85,129
|
)
|
5,507,663
|
5,618,669
|
||||||||
|
Cash at beginning of period
|
5,703,798
|
196,135
|
-
|
|||||||||
|
Cash at end of period
|
$
|
5,618,669
|
$
|
5,703,798
|
$
|
5,618,669
|
||||||
|
SUPPLEMENTAL CASH FLOWS INFORMATION:
|
||||||||||||
|
Cash paid for:
|
||||||||||||
|
Income tax
|
$
|
-
|
$
|
-
|
$
|
-
|
||||||
|
Interest
|
-
|
-
|
682
|
|||||||||
|
NONCASH INVESTING AND FINANCING ACTIVITIES:
|
||||||||||||
|
Beneficial conversion feature discount
|
$
|
-
|
$
|
372,850
|
$
|
372,850
|
||||||
|
Fair value of warrants issued with debt
|
-
|
377,150
|
377,150
|
|||||||||
|
Fair value of warrants issued with stock
|
3,393,338
|
2,591,900
|
5,985,238
|
|||||||||
|
Fair value of warrants issued to the placement agent
|
658,753
|
1,484,529
|
2,170,282
|
|||||||||
|
Conversion of notes payable and accrued interest to stock
|
981,729
|
-
|
981,729
|
|||||||||
|
Transfer from liability classification to equity classification
|
4,231,324
|
-
|
4,231,324
|
|||||||||
|
Level 1
|
Level 2
|
Level 3
|
Total
|
|||||||||||||
|
Derivative liabilities:
|
||||||||||||||||
|
At December 31, 2012
|
-
|
-
|
$
|
3,574,958
|
$
|
3,574,958
|
||||||||||
|
At December 31, 2011
|
-
|
-
|
4,439,613
|
4,439,613
|
||||||||||||
|
2012
|
2011
|
|||||||
|
Qualified R&D costs incurred by the Company
|
$
|
-
|
$
|
655,786
|
||||
|
Reimbursements received from MSKCC
|
237,834
|
966,341
|
||||||
|
Lives
|
2012
|
2011
|
|||||||
|
Office equipment
|
5 years
|
$
|
156,162
|
$
|
153,804
|
||||
|
Furniture and fixture
|
7 years
|
1,292
|
1,292
|
||||||
|
Total property, plant and equipment
|
157,454
|
155,096
|
|||||||
|
Less: accumulated depreciation
|
(154,444
|
)
|
(153,863
|
)
|
|||||
|
Property and equipment
|
$
|
3,010
|
$
|
1,233
|
|||||
|
2012
|
2011
|
|||||||
|
Principal amount
|
$
|
900,000
|
$
|
900,000
|
||||
|
Less: original issuance discount
|
(150,000
|
)
|
(150,000
|
)
|
||||
|
Less: discount related to fair value of derivative warrants
|
(377,150
|
)
|
(377,150
|
)
|
||||
|
Less: discount related to the beneficial conversion feature
|
(372,850
|
)
|
(372,850
|
)
|
||||
|
Add: amortization of discount
|
900,000
|
124,363
|
||||||
|
Less: principal amount converted to stock
|
(900,000
|
)
|
-
|
|||||
|
Carrying value at December 31, 2012 and 2011, respectively
|
$
|
-
|
$
|
124,363
|
||||
|
Units
|
Fair Value
|
|||||||
|
Balance, December 31, 2010
|
-
|
$
|
-
|
|||||
|
Warrants issued with Convertible Notes (See Note 5)
|
287,061
|
377,150
|
||||||
|
Placement agent warrants related to issuance of Convertible Notes (See Note 5)
|
143,532
|
188,579
|
||||||
|
Warrants issued with Stock Offering (See Note 9)
|
1,972,785
|
2,591,900
|
||||||
|
Placement agent warrants related to issuance of stock (See Note 9)
|
986,393
|
1,295,950
|
||||||
|
Change in fair value
|
-
|
(13,966
|
)
|
|||||
|
Balance, December 31, 2011
|
3,389,771
|
4,439,613
|
||||||
|
Warrants issued with Stock Offering (See Note 9)
|
242,190
|
318,087
|
||||||
|
Placement agent warrants related to Stock Offering (See Note 9)
|
121,095
|
159,044
|
||||||
|
Warrants issued with 2012 Common Stock Offering-A (See Note 9)
|
3,118,988
|
1,409,554
|
||||||
|
Warrants issued with 2012 Common Stock Offering-B (See Note 9)
|
1,559,505
|
1,665,697
|
||||||
|
Placement agent warrants related to 2012 Common Stock Offering (See Note 9)
|
467,845
|
499,707
|
||||||
|
Transfer from liability classification to equity classification
|
(3,753,056
|
)
|
(4,231,324
|
)
|
||||
|
Change in fair value
|
-
|
(685,420
|
)
|
|||||
|
Balance, December 31, 2012
|
5,146,338
|
$
|
3,574,958
|
|||||
|
December 31,
|
January 31,
|
December 19,
|
December 27,
|
December 31,
|
|||||
|
2011
|
2012
|
2012
|
2012
|
2012
|
|||||
|
Market value of common stock on measurement date (1)
|
$0.37
|
$0.37
|
$0.39
|
$0.39
|
$0.39
|
||||
|
Adjusted exercise price
|
$0.24 - $0.26
|
$0.23 - $0.26
|
$0.41 - $0.83
|
$0.22 - $0.26
|
$0.41 - $0.83
|
||||
|
Risk free interest rate (2)
|
1.35%
|
1.24%
|
0.10% - 0.77%
|
0.94%
|
0.10% - 0.77%
|
||||
|
Warrant lives in years
|
7 years
|
7 years
|
4 months/5years
|
6 years
|
4 months/5years
|
||||
|
Expected volatility (3)
|
156%
|
157%
|
125% - 161%
|
161%
|
125% - 161%
|
||||
|
Expected dividend yield (4)
|
-
|
-
|
-
|
-
|
-
|
||||
|
Probability of stock offering in any period over 5 years (5)
|
25%
|
25%
|
25%
|
25%
|
25%
|
||||
|
Range of percentage of existing shares offered (6)
|
35%
|
35%
|
35%
|
35%
|
35%
|
||||
|
Offering price range (7)
|
$0.18 - $0.55
|
$0.13 - $0.56
|
$0.01 - $0.55
|
$0.12 - $0.60
|
$0.01 - $0.55
|
|
(1)
|
The market value of common stock is based on an enterprise valuation.
|
|
(2)
|
The risk-free interest rate was determined by management using the average of 5 and 7 year and the 3-month Treasury Bill as of the respective measurement date.
|
|
(3)
|
Because the Company does not have adequate trading history to determine its historical trading volatility, the volatility factor was estimated by management using the historical volatilities of comparable companies in the same industry and region.
|
|
(4)
|
Management determined the dividend yield to be 0% based upon its expectation that it will not pay dividends for the foreseeable future.
|
|
(5)
|
Management has determined that the probability of a stock offering is 25% for each quarter of the next five years.
|
|
(6)
|
Management estimates that the range of percentages of existing shares offered in each stock offering will be between 35% of the shares outstanding.
|
|
(7)
|
Represents the estimated offering price range in future offerings as determined by management.
|
|
2012
|
2011
|
|||||||
|
Deferred tax assets:
|
||||||||
|
Net operating losses
|
$
|
13,609,036
|
$
|
13,089,314
|
||||
|
Share-based compensation
|
1,497,556
|
741,420
|
||||||
|
Other differences in tax basis
|
233,043
|
4,749
|
||||||
|
Total deferred tax assets
|
15,339,634
|
13,835,483
|
||||||
|
Less: valuation allowance
|
(15,339,634
|
)
|
(13,835,483
|
)
|
||||
|
Deferred tax assets, net
|
$
|
-
|
$
|
-
|
||||
|
For the years ended
|
||||||||||||||||
|
December 31, 2012
|
December 31, 2011
|
|||||||||||||||
|
Federal income taxes at 34%
|
$
|
(2,842,810
|
)
|
-34.00
|
%
|
$
|
(1,171,230
|
)
|
-34.00
|
%
|
||||||
|
Share-based compensation costs
|
756,136
|
9.04
|
%
|
736,796
|
21.39
|
%
|
||||||||||
|
Change in fair value of derivatives
|
233,043
|
2.79
|
%
|
4,748
|
0.13
|
%
|
||||||||||
|
Amortization of debt discounts
|
349,480
|
4.18
|
%
|
56,033
|
1.63
|
%
|
||||||||||
|
Change in valuation allowance
|
1,504,151
|
17.99
|
%
|
373,653
|
10.85
|
%
|
||||||||||
|
Provision for income tax
|
$
|
-
|
-
|
$
|
-
|
-
|
||||||||||
|
a.
|
Abbott Biotherapeutics Corp – The Company entered into a Product Development and Patent License Agreement with Abbott Biotherapeutics Corp. (formerly Facet Biotech formerly known as Protein Design Labs) in 2003 to secure exclusive rights to a specific antibody when conjugated with alpha emitting radioisotopes. Upon execution of the agreement, the Company made a license fee payment of $3,000,000.
|
|
Milestones
|
Payments
|
|||
|
(1) when Company initiates a Phase I Clinical Trial of a licensed product
|
$
|
750,000
|
||
|
(2) when Company initiates a Phase II Clinical Trial of a licensed product
|
750,000
|
|||
|
(3) when Company initiates a Phase III Clinical Trial of a licensed product
|
1,500,000
|
|||
|
(4) Biological License Application filing with U.S. FDA
|
1,750,000
|
|||
|
(5) First commercial sale
|
1,500,000
|
|||
|
(6) after the first $10,000,000 in net sales
|
1,500,000
|
|||
|
b.
|
MSKCC – In February 2002, the Company entered into a license agreement with MSKCC that requires a technology access fee of $50,000 upon execution, an annual maintenance fee of $50,000 and an annual research funding of $50,000 for as long as the agreement is in force.
|
|
Milestones
|
Payments
|
|||
|
1) filing of an New Drug Application (“NDA”) or regulatory approval
|
||||
|
for each licensed product
|
$
|
750,000
|
||
|
(2) upon the receipt of regulatory approval from the U.S. FDA for each
|
||||
|
licensed product
|
1,750,000
|
|||
|
c.
|
Oak Ridge National Laboratory (ORNL) – API has contracted to purchase radioactive material to be used for research and development through December 2012. API is contracted to purchase $233,100 of radioactive material to be used for research and development, with a renewal option at the contract end. The Company is currently negotiating the 2013 agreement.
|
|
d.
|
AptivSolutions provides project management services for the study of the drug Ac-225-HuM195 (Actimab-A) used in the Company clinical trials, Phase I and Phase II. The total project is estimated to cost $1,859,333 and requires a 12.5% down payment of the total estimated project cost. The down payment totaling $239,000 was paid in 2007 and 2012. On August 6, 2012, the agreement was amended to provide for additional services. The total project is now estimated at $1,997,732. AptivSolutions bills the Company when services are rendered and the Company records the related expense to research and development costs.
|
|
e.
|
On June 15, 2012, the Company entered into a license and sponsored research agreement with Fred Hutchinson Cancer Research Center (FHCRC). The Company will build upon previous and ongoing clinical trials, with BC8 (licensed antibody) and eventually develop a clinical trial with Actinium 225. FHCRC has currently completed Phase I and Phase II of the clinical trial and the Company intends to start preparation for a pivotal trial leading to an FDA approval. The Company has been granted exclusive rights to the BC8 antibody and related master cell bank developed by FHCRC. The cost to develop the trial will range from $13.2 million to $23.5 million, depending on the trial design as required by the FDA. Under the terms of the sponsored research agreement, the Company will fund the FHCRC lab with $150,000 per year for the first two years and $250,000 thereafter. Payments made toward funding the lab will be credited toward royalty payments owed to FHCRC in the given year. A milestone payment of $1 million will be due to FHCRC upon FDA approval of the first drug. Upon commercial sale of the drug, royalty payments of 2% of net sales will be due to FHCRC.
|
|
f.
|
On March 27, 2012, the Company entered into a clinical trial agreement with Memorial Sloan Kettering Cancer Center. The Company will pay $31,185 for each patient that has completed the clinical trial. Upon execution of the agreement, the Company is required to pay a start-up fee of $79,623. The amount due of $79,623 was paid on July 10, 2012.
|
|
g.
|
On May 9, 2011, Actinium entered into a transaction management agreement with Jamess Capital Group, LLC. (formerly known as Amerasia Capital Group, LLC), a consulting firm affiliated with Mr. Sandesh Seth, a Director of Cactus Ventures, Inc. by virtue of his position as a director of Actinium Pharmaceuticals. Mr. Seth is a Managing Partner of the consulting firm some of whose member interests are held by entities owned by officers and employees of the Placement Agent. None of Cactus’ current officers or directors had a prior relationship or affiliation with Cactus prior to the closing of the Share Exchange. Pursuant to the agreement, the management firm was engaged to provide consulting services to Actinium related to the consummation of a going public transaction for Actinium. The management firm received a monthly fee of $12,500 which is terminable by the Company three months after the effective date of the going public transaction and designees of Jamess, including entities affiliated with Mr. Seth, were issued warrants to purchase common stock equal to 10% of the fully-diluted capital stock of the Company as of the effective date of the going public transaction. The fully diluted shares for this calculation included all issued and outstanding shares as well as those reserved under the Employee Stock Option Plan. Jamess Capital Group does not retain beneficial ownership of the warrants as they were issued to designess of the members in amounts which do not qualify either Jamess or the warrant holders for inclusion in the beneficial ownership table. The warrants contain a provision wherein the holder may waive the 90 day exercise notice requirement by giving 65 days prior notice of such waiver. The shares available by exercise of this Warrant are also restricted and may not be sold or otherwise transfered until the earlier of twelve months from the closing date of the Pubco Transaction; or for six months after the planned Registration Statement is declared effective. The consulting firm is also eligible to be reimbursed upon the submission of proper documentation for ordinary and necessary out-of-pocket expenses not to exceed $5,000 per month.
|
|
h.
|
On July 19, 2012, the Company entered into a clinical trial agreement with FHCRC. The Company will pay $31,366 for each patient that has completed the clinical trial. Upon execution of the agreement, the Company is required to pay a start-up fee of $19,749. During the clinical trial additional fees apply and will be invoiced when applicable. The amount due has not been invoiced but accrued by the Company as of December 31, 2012.
|
|
i.
|
On August 28, 2012, the Company entered into a clinical trial agreement with The University of Texas M.D. Anderson Cancer Center. The total estimated cost of conducting the clinical trial is $481,204, which includes a non- refundable institutional fee of $14,500. The estimated cost is based on treating 24 patients through 2013. Upon execution of the agreement, the Company is required to make a payment of $33,946. The amount due has not been invoiced but accrued by the Company as of December 31, 2012.
|
|
j.
|
On September 26, 2012, the Company entered into a clinical trial agreement with Johns Hopkins University. The Phase I/II clinical trial will be conducted with Actinium 225. The clinical trial will be conducted under the protocols established by the Company and pursuant to an Investigational New Drug Exemption (IND 10807) held by the Company. The Company will pay $38,501 per patient, who has completed the clinical trial. The Company is required to pay a start-up fee of $22,847, an annual pharmacy fee of $2,025 and an amendment processing fee of $500, when applicable. The amount due has not been invoiced but accrued by the Company as of December 31, 2012.
|
|
k.
|
On November 21, 2012, the Company entered into a clinical trial agreement with the University of Pennsylvania. The Phase I/II clinical trial will be conducted with Actinium 225. The clinical trial will be conducted under the protocols established by the Company and pursuant to an Investigational New Drug Exemption (IND 10807) held by the Company. The Company will pay $31,771 per patient, who has completed the clinical trial. The Company will be required to pay a start-up fee of $16,000 and additional administrative fees, when applicable.
|
|
Weighted
|
||||||||||||||||
|
Average
|
||||||||||||||||
|
Weighted
|
Remaining
|
Aggregate
|
||||||||||||||
|
Average
|
Contractual
|
Intrinsic
|
||||||||||||||
|
Number of Units
|
Exercise Price
|
Term (in years)
|
Value
|
|||||||||||||
|
Outstanding, December 31, 2010
|
273,859
|
$
|
1.29
|
5.51
|
$
|
-
|
||||||||||
|
Granted
|
-
|
-
|
-
|
|||||||||||||
|
Outstanding, December 31, 2011
|
273,859
|
1.29
|
5.51
|
-
|
||||||||||||
|
Granted
|
2,056,275
|
0.96
|
8.89
|
|||||||||||||
|
Outstanding, December 31, 2012
|
2,330,134
|
$
|
0. 96
|
8.91
|
$
|
685,800
|
||||||||||
|
Warrants issued with convertible notes (See Note 5)
|
287,061
|
|||
|
Warrants issued to investors with Stock Offering (See Note 9)
|
1,972,766
|
|||
|
Placement agent warrants related to issuance of:
|
||||
|
Convertible Notes
|
143,532
|
|||
|
Stock Offering (See Note 6 and Note 9)
|
986,383
|
|||
|
Total
|
3,389,752
|
|
Warrants issued to investors with Stock Offering (See Note 6)
|
242,189
|
|||
|
Warrants issued to investors with Common Stock
|
4,678,491
|
|||
|
Placement agent warrants related to issuance of:
|
||||
|
Stock Offering (See Note 6 and Note 9)
|
121,094
|
|||
|
2012 Common Stock Offering
|
467,845
|
|||
|
Warrants issued to investors with stock – accrued dividend
|
180,115
|
|||
|
Total
|
5,689,734
|
|
Weighted
|
||||||||||||||||
|
Average
|
||||||||||||||||
|
Weighted
|
Remaining
|
Aggregate
|
||||||||||||||
|
Average
|
Contractual
|
Intrinsic
|
||||||||||||||
|
Number of Units
|
Exercise Price
|
Term (in years)
|
Value
|
|||||||||||||
|
Outstanding, December 31, 2010
|
-
|
$
|
-
|
-
|
$
|
-
|
||||||||||
|
Granted
|
5,364,557
|
0.51
|
6.76
|
|||||||||||||
|
Outstanding, December 31, 2011
|
5,364,557
|
0.51
|
6.76
|
3,261,367
|
||||||||||||
|
Granted
|
7,406,079
|
1.32
|
3.76
|
|||||||||||||
|
Outstanding, December 31, 2012
|
12,770,636
|
$
|
0. 97
|
4.48
|
$
|
6,114,768
|
||||||||||
|
Name
|
Age
|
Position
|
||
|
Sergio Traversa, MBA
|
52
|
Interim Chief Executive Officer, President, Interim Chief Financial Officer and Director
|
||
|
Dragan Cicic, MD
|
49
|
Chief Operating Officer and Chief Medical Officer
|
||
|
Rosemary Mazanet, MD, PhD
|
57
|
Director
|
||
|
David Nicholson, PhD
|
58
|
Director
|
||
|
Sandesh Seth, MS, MBA
|
48
|
Director
|
|
●
|
the director is, or at any time during the past three years was, an employee of the company;
|
|
●
|
the director or a family member of the director accepted any compensation from the company in excess of $120,000 during any period of 12 consecutive months within the three years preceding the independence determination (subject to certain exclusions, including, among other things, compensation for board or board committee service);
|
|
●
|
a family member of the director is, or at any time during the past three years was, an executive officer of the company;
|
|
●
|
the director or a family member of the director is a partner in, controlling stockholder of, or an executive officer of an entity to which the company made, or from which the company received, payments in the current or any of the past three fiscal years that exceed 5% of the recipient’s consolidated gross revenue for that year or $200,000, whichever is greater (subject to certain exclusions);
|
|
●
|
the director or a family member of the director is employed as an executive officer of an entity where, at any time during the past three years, any of the executive officers of the company served on the compensation committee of such other entity; or
|
|
●
|
the director or a family member of the director is a current partner of the company’s outside auditor, or at any time during the past three years was a partner or employee of the company’s outside auditor, and who worked on the company’s audit.
|
|
Audit Committee
|
Compensation Committee
|
|
|
Dr. Sergio Traversa*
|
Dr. David Nicholson*
|
|
|
Dr. David Nicholson
|
Dr. Rosemary Mazanet
|
|
|
Dr. Rosemary Mazanet
|
Sandesh Seth
|
|
●
|
establishing and periodically reviewing our compensation philosophy and the adequacy of compensation plans and programs for our directors, executive officers and other employees;
|
|
●
|
overseeing our compensation plans, including the establishment of performance goals under the company’s incentive compensation arrangements and the review of performance against those goals in determining incentive award payouts;
|
|
●
|
overseeing our executive employment contracts, special retirement benefits, severance, change in control arrangements and/or similar plans;
|
|
●
|
acting as administrator of any company stock option plans; and
|
|
●
|
overseeing the outside consultant, if any, engaged by the compensation committee.
|
|
●
|
been convicted in a criminal proceeding or been subject to a pending criminal proceeding (excluding traffic violations and other minor offenses);
|
|
|
●
|
had any bankruptcy petition filed by or against the business or property of the person, or of any partnership, corporation or business association of which he was a general partner or executive officer, either at the time of the bankruptcy filing or within two years prior to that time;
|
|
|
●
|
been subject to any order, judgment, or decree, not subsequently reversed, suspended or vacated, of any court of competent jurisdiction or federal or state authority, permanently or temporarily enjoining, barring, suspending or otherwise limiting, his involvement in any type of business, securities, futures, commodities, investment, banking, savings and loan, or insurance activities, or to be associated with persons engaged in any such activity;
|
|
|
●
|
been found by a court of competent jurisdiction in a civil action or by the SEC or the Commodity Futures Trading Commission to have violated a federal or state securities or commodities law, and the judgment has not been reversed, suspended, or vacated;
|
|
|
●
|
been the subject of, or a party to, any federal or state judicial or administrative order, judgment, decree, or finding, not subsequently reversed, suspended or vacated (not including any settlement of a civil proceeding among private litigants), relating to an alleged violation of any federal or state securities or commodities law or regulation, any law or regulation respecting financial institutions or insurance companies including, but not limited to, a temporary or permanent injunction, order of disgorgement or restitution, civil money penalty or temporary or permanent cease-and-desist order, or removal or prohibition order, or any law or regulation prohibiting mail or wire fraud or fraud in connection with any business entity; or
|
|
|
●
|
been the subject of, or a party to, any sanction or order, not subsequently reversed, suspended or vacated, of any self-regulatory organization (as defined in Section 3(a)(26) of the Exchange Act), any registered entity (as defined in Section 1(a)(29) of the Commodity Exchange Act), or any equivalent exchange, association, entity or organization that has disciplinary authority over its members or persons associated with a member.
|
|
Name/Position
|
Year
|
Salary
|
Bonus
|
Option
Awards
|
All Other Compensation
|
Total
|
||||||||||||||||||
|
Jack Talley,
former CEO, resigned
on February 28, 2013
|
2012
2011
2010
|
$
|
250,000
-
-
|
$
|
-
-
-
|
$
|
58,412
-
-
|
$
|
-
-
-
|
$
|
308,412
-
-
|
|||||||||||||
|
Dragan Cicic, COO
|
2012
2011
2010
|
$
|
190,658
190,658
190,658
|
$
|
-
50,000
-
|
$
|
58,426
9,717
9,717
|
$
|
-
-
-
|
$
|
249,084
250,375
200,375
|
|||||||||||||
|
Enza Guagenti,
former CFO, resigned
on March 9, 2013
|
2012
2011
2010
|
$
|
90,000
-
-
|
$
|
-
-
-
|
$
|
3,394
-
-
|
$
|
-
-
-
|
$
|
93,394
-
-
|
|||||||||||||
|
Diane Button,CEO, CFO, resigned as the Company's CEO and CFO on December 28, 2012.
|
2012
2011
2010
|
$
$
$
|
-
-
-
|
$
$
$
|
-
-
-
|
$
$
$
|
-
-
-
|
$
$
$
|
-
-
6,000
|
$
$
$
|
-
-
6,000
|
|||||||||||||
|
●
|
shall, to the maximum extent and in the manner specified in the [NRS], indemnify each of its directors and officers against expenses, judgments, fines, settlements, and other amounts actually and reasonably incurred in connection with any proceeding arising by reason of the fact that any such person is or was a director or officer of the Corporation. The Corporation shall have the power to advance expenses incurred in defending any proceeding prior to the disposition of the proceeding upon receipt of an undertaking by or on behalf of the director or officer to repay that amount if it shall be determined ultimately that the person is not entitled to indemnification.
|
|
Executive Officers
and Directors
|
Number of Shares of Common
Stock and Preferred Stock
Beneficially Owned
|
Percentage of
Ownership(a)
|
||||||
|
Dragan Cicic, MD
|
163,037
|
(1)
|
0.8
|
%
|
||||
|
Rosemary Mazanet
|
48,285
|
(2)
|
0.2
|
%
|
||||
|
David Nicholson
|
3,996
|
(3)
|
0.0
|
%
|
||||
|
Sandesh Seth
|
164,365
|
(4)
|
0.8
|
%
|
||||
|
Sergio Traversa
|
0
|
(5)
|
0.0
|
%
|
||||
|
All Directors and Officers as a Group (7 persons)
|
379,683
|
1.8
|
%
|
|||||
|
All other 5% holders
|
||||||||
|
AHLB Holdings, LLC. (6)
c/o Memorial Sloan-Kettering Cancer Center
1275 York Avenue
New York, NY 10065
|
5,702,387
|
26.7
|
%
|
|||||
|
(a)
|
Based on 21,391,665 shares of Common Stock outstanding as of March 12, 2013, and includes 400,000 shares of common stock of the Company that remained outstanding after the closing of the Share Exchange.
|
|
2012
|
2011
|
|||||||
|
Qualified R&D costs incurred by Actinium
|
$
|
-
|
$
|
655,786
|
||||
|
Cash received from MSKCC
|
237,834
|
966,341
|
||||||
|
Year Ended
December 31, 2012
|
Year Ended
December 31, 2011
|
|||||||
|
Audit Fees
|
$
|
92,445
|
$
|
-
|
||||
|
Tax Fees
|
-
|
-
|
||||||
|
All Other Fees
|
-
|
-
|
||||||
|
Total
|
$
|
92,445
|
$
|
-
|
||||
|
Exhibit
Number
|
Description
|
|
|
2.1
|
Share Exchange Agreement, dated December 28, 2012, by and among Cactus Ventures, Inc., Actinium Pharmaceuticals, Inc., Diane S. Button, and the shareholders of Actinium Pharmaceuticals, Inc. (incorporated by reference to Exhibit 2.1 to Form 8-K filed on January 2, 2013).
|
|
|
2.2
|
Share Exchange Agreement, dated March 11, 2013, by and among Cactus Ventures, Inc., Actinium Pharmaceuticals, Inc, and the shareholders of Actinium Pharmaceuticals, Inc. (incorporated by reference to Exhibit 10.1 to Form 8-K filed on March 11, 2013).
|
|
|
3.1
|
Articles of Incorporation of Cactus Ventures, Inc.(incorporated by reference to Exhibit 3.01 of the Company’s Registration Statement on Form 10-SB filed with the SEC on February 5, 2007).
|
|
|
3.2
|
Amendment No. 1 to the Articles of Incorporation of Cactus Ventures, Inc. (incorporated by reference to Exhibit 3.02 of the Company’s Registration Statement on Form 10-SB filed with the SEC on February 5, 2007).
|
|
|
3.3
|
Amendment No. 2 to the Articles of Incorporation of Cactus Ventures, Inc. (incorporated by reference to Exhibit 3.03 of the Company’s Registration Statement on Form 10-SB filed with the SEC on February 5, 2007).
|
|
|
3.4
|
Amendment No. 3 to the Articles of Incorporation of Cactus Ventures, Inc. (incorporated by reference to Exhibit 3.04 of the Company’s Registration Statement on Form 10-SB filed with the SEC on February 5, 2007).
|
|
|
3.5
|
Fifth Restated Certificate of Incorporation of Actinium Pharmaceuticals, Inc. (incorporated by reference to Exhibit 3.5 to Form 8-K filed on January 2, 2013).
|
|
|
3.6
|
Bylaws of Cactus Ventures, Inc. (incorporated by reference to Exhibit 3.05 of the Company’s Registration Statement on Form 10-SB filed with the SEC on February 5, 2007).
|
|
|
3.7
|
Bylaws of Actinium Pharmaceuticals, Inc. (incorporated by reference to Exhibit 3.7 to Form 8-K filed on January 2, 2013).
|
|
|
4.1
|
Form of A Warrant, dated December 19, 2012 (incorporated by reference to Exhibit 4.1 to Form 8-K filed on January 2, 2013).
|
|
|
4.2
|
Form of B Warrant, dated December 19, 2012 (incorporated by reference to Exhibit 4.2 to Form 8-K filed on January 2, 2013).
|
|
|
4.3
|
Form of Lock Up Agreement, dated December ____, 2012 (incorporated by reference to Exhibit 4.3 to Form 8-K filed on January 2, 2013).
|
|
|
5.1
|
Opinion of Anslow & Jaclin, LLP *
|
|
|
10.1
|
Registration Rights Agreement, by and among Actinium Pharmaceuticals, Inc., General Atlantic Investments Limited, and Certain Stockholders, dated June 30, 2000 (incorporated by reference to Exhibit 10.1 to Form 8-K filed on January 2, 2013).
|
|
|
10.2
|
Amendment No. 1 to June 30, 2000 Registration Rights Agreement, dated September 29, 2011 (incorporated by reference to Exhibit 10.2 to Form 8-K/A filed on January 4, 2013).
|
|
|
10.3
|
First Amended and Restated Stockholders Agreement, by and among Actinium Pharmaceuticals, Inc., Actinium Holdings Limited, N.V. Organon, and the Stockholders Listed Therein, dated October 5, 2011(incorporated by reference to Exhibit 10.3 to Form 8-K/A filed on January 4, 2013).
|
|
|
10.4
|
Second Amended and Restated Investor Rights Agreement, by and among Actinium Pharmaceuticals, Inc., Actinium Holdings Limited, and the Investors Listed Therein, dated October 5, 2011 (incorporated by reference to Exhibit 3.5 to Form 8-K filed on January 4, 2013).
|
|
|
10.5
|
Intentionally left blank.
|
|
|
10.6
|
Form of Subscription Agreement, dated December 19, 2012 (incorporated by reference to Exhibit 10.6 to Form 8-K filed on January 2, 2013).
|
|
|
10.7
|
Form of Unit Purchase Agreement, dated December 19, 2012 (incorporated by reference to Exhibit 10.7 to Form 8-K filed on January 2, 2013).
|
|
|
10.8
|
Employment Agreement, dated January 2, 2006, between Actinium Pharmaceuticals, Inc. and Dragan Cicic (incorporated by reference to Exhibit 10.8 to Form 8-K/A filed on January 4, 2013).
|
|
10.9
|
License, Development and Commercialization Agreement between Sloan-Kettering Institute of Cancer Research, and Actinium Pharmaceuticals, Inc., dated February 11, 2002; as amended by the First Amendment dated August 7, 2006 (incorporated by reference to Exhibit 10.9 to Form 8-K/A filed on January 4, 2013).
|
|
|
10.10
|
Phase I/II Study on the safety and efficiency of 225ACAc-HuM195 in patients with advanced Myeloid malignancies with Millennix Oncology, Averion Project, dated December 6, 2006 (incorporated by reference to Exhibit 3.5 to Form 8-K filed on January 4, 2013).
|
|
|
10.11
|
Product Development and Patent License Agreement, dated February 27, 2003, by and between Abbott Biotherapeutics and Actinium Pharmaceuticals, Inc. (incorporated by reference to Exhibit 10.11 to Form 8-K/A filed on January 4, 2013).
|
|
|
10.12
|
Clinical Trial Agreement, dated July 19, 2012, by and between Fred Hutchinson Cancer Center and Actinium Pharmaceuticals, Inc. (incorporated by reference to Exhibit 10.12 to Form 8-K/A filed on January 4, 2013).
|
|
|
10.13
|
Employment Letter between Jack V. Talley and Actinium Pharmaceuticals, Inc., effective August 15, 2012 (incorporated by reference to Exhibit 3.5 to Form 8-K filed on January 4, 2013).
|
|
10.14
|
Employment Letter between Enza Guagenti and Actinium Pharmaceuticals, Inc., effective August 15, 2012 (incorporated by reference to Exhibit 10.14 to Form 8-K/A filed on January 4, 2013).
|
|
|
10.15
|
Clinical Trial Agreement, dated January 18, 2001, between Actinium Pharmaceuticals, Inc. and Memorial Sloan Kettering Cancer Center for the purpose of conducting a clinical trial entitled “Phase I/II trial of 213Bi-M195 and cytarabine for Acute Myeloid Leukemia.” (incorporated by reference to Exhibit 10.15 to Form 8-K/A filed on January 4, 2013).
|
|
|
10.16
|
Clinical Trial Agreement with The Trustees of the University of Pennsylvania, dated November 8, 2012 (incorporated by reference to Exhibit 10.16 to Form 8-K/A filed on January 4, 2013).
|
|
|
10.17
|
Clinical Trial Agreement, dated March 27, 2012, with Memorial Sloan-Kettering Cancer Center (incorporated by reference to Exhibit 10.17 to Form 8-K/A filed on January 4, 2013).
|
|
|
10.18
|
Clinical Trial Agreement, dated September 22, 2012, with Johns Hopkins University, dated September 24, 2012 (incorporated by reference to Exhibit 10.18 to Form 8-K/A filed on January 4, 2013).
|
|
|
10.19
|
License Agreement, dated June 14, 2012, for BC8 antibody with Fred Hutchinson Cancer Research Center (incorporated by reference to Exhibit 10.19 to Form 8-K/A filed on January 4, 2013).
|
|
|
10.20
|
2012 Unit Investor Rights Agreement, dated December 19, 2012, by and among Actinium Pharmaceuticals, Inc., the persons identified on Exhibit A attached thereto hereto, and the Placement Agent (incorporated by reference to Exhibit 10.20 to Form 8-K/A filed on January 4, 2013).
|
|
|
10.21
|
Project Agreement, dated September 30, 2011, between Actinium Pharmaceuticals, Inc. and Aptiv Solutions, Inc. (incorporated by reference to Exhibit 10.21 to Form 8-K/A filed on January 4, 2013).
|
|
|
10.22
|
Proposal, dated March 30, 2007, with IsoTherapeutics Group, LLC (incorporated by reference to Exhibit 10.22 to Form 8-K/A filed on January 4, 2013).
|
|
|
10.23
|
Clinical Trial Agreement with The University of Texas M.D. Anderson Cancer, dated March 1, 2012 (incorporated by reference to Exhibit 10.23 to Form 8-K/A filed on January 4, 2013).
|
|
|
10.24
|
Amendment No. 1 to Research Agreement, dated November 7, 2012, between Actinium Pharmaceuticals, Inc. and The University of Texas M.D. Anderson Cancer (incorporated by reference to Exhibit 10.24 to Form 8-K/A filed on January 4, 2013).
|
|
10.25
|
Letter Agreement, dated June 19, 2011, between Actinium Pharmaceuticals, Inc. and Sloan-Kettering Institute for Cancer Research (incorporated by reference to Exhibit 10.25 to Form 8-K/A filed on January 4, 2013).
|
|
|
10.26
|
Letter Agreement, dated April 9, 2010, between Actinium Pharmaceuticals, Inc. and Sloan-Kettering Institute for Cancer Research (incorporated by reference to Exhibit 10.26 to Form 8-K/A filed on January 4, 2013).
|
|
|
10.27
|
Letter Agreement, dated July __, 2010, between Actinium Pharmaceuticals, Inc. and Actinium Holdings Limited (Waiver of Anti-Dilution Rights) (incorporated by reference to Exhibit 10.27 to Form 8-K/A filed on January 4, 2013).
|
|
|
10.28
|
Clinical Trial Agreement, dated April 12, 2006, with Sloan-Kettering Institute for Cancer Research and Memorial Hospital for Cancer and Allied Diseases (incorporated by reference to Exhibit 10.28 to Form 8-K /A filed on January 4, 2013).
|
|
|
10.29
|
Letter Agreement, dated __, 2011, between Actinium Pharmaceuticals, Inc. and Actinium Holdings Limited (Waiver of Registration Rights) (incorporated by reference to Exhibit 10.29 to Form 8-K/A filed on January 4, 2013).
|
|
14.1
|
Code of Ethics (incorporated by reference to Exhibit 14.1 to Form 8-K filed on January 2, 2013).
|
|
| 21.1 | Subsidiaries |
|
31.1
|
Certification of Principal Executive Officer and Principal Financial Officer, pursuant to 18 U.S.C. Section 1350 as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
|
|
|
32.1*
|
Certification of Principal Executive Officer and Principal Financial Officer, pursuant to 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 Schema
|
|
101.CAL **
|
XBRL Taxonomy Calculation Linkbase
|
|
101.DEF **
|
XBRL Taxonomy Definition Linkbase
|
|
101.LAB **
|
XBRL Taxonomy Label Linkbase
|
|
101.PRE **
|
XBRL Taxonomy Presentation Linkbase
|
|
Dated: March 29, 2013
|
CACTUS VENTURES, INC.
|
|||
|
By:
|
/s/ Sergio Traversa
|
|||
|
Sergio Traversa
|
||||
|
Interim President, Interim Chief Executive Officer and Interim Chief Financial Officer
(Duly Authorized Officer, Principal Executive Officer and Principal Financial officer)
|
||||
|
Signature
|
Title
|
Date
|
||
|
/s/ Sergio Traversa
|
Interim President, Interim Chief Executive Officer,
|
March 29, 2013
|
||
|
Sergio Traversa
|
Interim Chief Financial Officer and Director | |||
|
(Principal Executive Officer)
|
||||
|
/s/ Rosemary Mazanet
|
Director
|
March 29, 2013
|
||
|
Rosemary Mazanet
|
||||
|
/s/ David Nicholson
|
Director
|
March 29, 2013
|
||
|
David Nicholson
|
|
/s/ Sandesh Seth
|
Director
|
March 29, 2013
|
||
|
Sandesh Seth
|
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 |
|---|