Delaware
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000-52446
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(State or Other Jurisdiction of Incorporation or Organization)
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(I.R.S. Employer Identification No.)
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501 Fifth Avenue, 3rd Floor
New York, NY
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10017
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(Address of Principal Executive Offices)
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(Zip Code)
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Large accelerated filer o | Accelerated filer o |
Non-accelerated filer o . (Do not check if a smaller reporting company) | Smaller reporting company x . |
Item 1.
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Financial Statements
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3
|
Item 2.
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Management’s Discussion and Analysis of Financial Condition and Results of Operations
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16
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Item 3.
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Quantitative and Qualitative Disclosures About Market Risk
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23
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Item 4.
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Controls and Procedures
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23
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PART II-- OTHER INFORMATION
|
||
Item 1.
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Legal Proceedings
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24
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Item 1A.
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Risk Factors
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24
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Item 2.
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Unregistered Sales of Equity Securities and Use of Proceeds
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24
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Item 3.
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Defaults Upon Senior Securities
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24
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Item 4.
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Mine Safety Disclosures
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24
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Item 5.
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Other Information
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24
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Item 6.
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Exhibits
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24
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Actinium Pharmaceuticals, Inc.
(Formerly Cactus Ventures, Inc.)
|
(A Development Stage Company)
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Consolidated Balance Sheets
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(Unaudited)
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March 31,
2013
|
December 31, 2012
|
|||||||
|
||||||||
Assets
|
||||||||
Current Assets:
|
||||||||
Cash and cash equivalents
|
$ | 3,239,886 | $ | 5,618,669 | ||||
Prepaid expenses and other current assets
|
117,143 | 167,143 | ||||||
Total Current Assets
|
3,357,029 | 5,785,812 | ||||||
Property and equipment, net of accumulated depreciation
|
- | 3,010 | ||||||
Total Assets
|
$ | 3,357,029 | $ | 5,788,822 | ||||
Liabilities and Stockholders' Equity
|
||||||||
Current Liabilities:
|
||||||||
Accounts payable and accrued expenses
|
$ | 459,923 | $ | 897,044 | ||||
Accounts payable and accrued expenses - related party
|
31,185 | 31,185 | ||||||
Notes payable
|
74,667 | 140,000 | ||||||
Derivative liabilities
|
2,240,446 | 3,574,958 | ||||||
Total Current Liabilities
|
2,806,221 | 4,643,187 | ||||||
Commitments and contingencies
|
||||||||
Stockholders' Equity:
|
||||||||
Preferred stock, $0.01 par value; 10,000,000 authorized
|
||||||||
none issued and outstanding
|
- | - | ||||||
Common stock, $0.01 par value; 100,000,000 shares authorized;
|
||||||||
and 21,391,665 shares issued and outstanding
|
213,916 | 213,916 | ||||||
Additional paid in capital
|
56,769,382 | 56,675,182 | ||||||
Deficit accumulated during the development stage
|
(56,432,490 | ) | (55,743,463 | ) | ||||
Total Stockholders' Equity
|
550,808 | 1,145,635 | ||||||
Total Liabilities and Stockholders' Equity
|
$ | 3,357,029 | $ | 5,788,822 |
Actinium Pharmaceuticals, Inc.
|
(Formerly Cactus Ventures, Inc.)
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(A Development Stage Company)
|
Consolidated Statements of Operations
(Unaudited)
|
For the Period
|
||||||||||||
For the Three
|
For the Three
|
from June 13, 2000
|
||||||||||
Months Ended
|
Months Ended
|
(Inception) to
|
||||||||||
March 31,
|
March 31,
|
March 31,
|
||||||||||
2013
|
2012
|
2013
|
||||||||||
|
|
|
||||||||||
Revenue
|
$ | - | $ | - | $ | - | ||||||
Operating Expenses:
|
||||||||||||
Research and development, net of reimbursements
|
1,085,707 | 444,886 | 27,506,226 | |||||||||
General and administrative
|
933,135 | 560,276 | 25,438,110 | |||||||||
Depreciation and amortization
|
- | 158 | 3,262,462 | |||||||||
Loss on disposition of equipment
|
4,122 | - | 554,308 | |||||||||
Total Operating Expenses
|
2,022,964 | 1,005,320 | 56,761,106 | |||||||||
Loss From Operations
|
(2,022,964 | ) | (1,005,320 | ) | (56,761,106 | ) | ||||||
Other Income and (Expense):
|
||||||||||||
Interest expense
|
(575 | ) | (312,890 | ) | (1,965,282 | ) | ||||||
Gain on extinguishment of liability
|
- | - | 260,000 | |||||||||
Gain on change in fair value of derivative liabilities
|
1,334,512 | 409,301 | 2,033,898 | |||||||||
Total Other Income and (Expense)
|
1,333,937 | 96,411 | 328,616 | |||||||||
Net Loss
|
$ | (689,027 | ) | $ | (908,909 | ) | $ | (56,432,490 | ) | |||
Net Loss Per Common Share - Basic and Diluted
|
$ | (0.03 | ) | $ | (0.07 | ) | ||||||
Weighted Average Number of Common Shares Outstanding
|
||||||||||||
- Basic and Diluted
|
21,391,665 | 13,701,674 |
Actinium Pharmaceuticals, Inc.
|
(Formerly Cactus Ventures, Inc.)
|
(A Development Stage Company)
|
Consolidated Statements of Cash Flows
|
(Unaudited)
|
For the Period
|
||||||||||||
For the Three
|
For the Three
|
from June 13, 2000
|
||||||||||
Months Ended
|
Months Ended
|
(Inception) to
|
||||||||||
March 31,
|
March 31,
|
March 31,
|
||||||||||
2013
|
2012
|
2013
|
||||||||||
Cash Flows From Operating Activities:
|
||||||||||||
Net loss
|
$ | (689,027 | ) | $ | (908,909 | ) | $ | (56,432,490 | ) | |||
Adjustments to reconcile net loss to net cash used in
|
||||||||||||
operating activities:
|
||||||||||||
Stock-based compensation expense
|
94,200 | 199,990 | 6,146,236 | |||||||||
Depreciation expense
|
- | 158 | 3,262,462 | |||||||||
Loss on disposition of equipment
|
4,122 | - | 554,308 | |||||||||
Amortization of debt discount
|
- | 221,918 | 900,000 | |||||||||
Amortization of deferred financing costs
|
- | 72,972 | 292,692 | |||||||||
Gain on extinguishment of liability
|
- | - | (260,000 | ) | ||||||||
Gain on change in fair value of derivative liabilities
|
(1,334,512 | ) | (409,301 | ) | (2,033,898 | ) | ||||||
Changes in operating assets and liabilities:
|
||||||||||||
(Increase) decrease in:
|
||||||||||||
R&D reimbursable receivable
|
- | 50,068 | - | |||||||||
Prepaid expenses and other current assets
|
50,000 | (11,568 | ) | 22,857 | ||||||||
Increase (decrease) in:
|
||||||||||||
Accounts payable and accrued expenses
|
(437,121 | ) | (163,255 | ) | 801,652 | |||||||
Accounts payable and accrued expenses - related party
|
- | 31,185 | ||||||||||
Net Cash Used In Operating Activities
|
(2,312,338 | ) | (947,927 | ) | (46,714,996 | ) | ||||||
Cash Flows From Investing Activities:
|
||||||||||||
Payment made for patent rights
|
- | - | (3,000,000 | ) | ||||||||
Purchase of property and equipment
|
(1,112 | ) | (1,157 | ) | (816,771 | ) | ||||||
Net Cash Used In Investing Activities
|
(1,112 | ) | (1,157 | ) | (3,816,771 | ) | ||||||
Cash Flows From Financing Activities:
|
||||||||||||
Borrowings on convertible debt, net of offering costs
|
- | - | 645,888 | |||||||||
Sales of stock, net of offering costs
|
- | 660,164 | 53,191,098 | |||||||||
Payments on note payable
|
(65,333 | ) | - | (65,333 | ) | |||||||
Net Cash Provided By (Used in) Financing Activities
|
(65,333 | ) | 660,164 | 53,771,653 | ||||||||
Net change in cash
|
(2,378,783 | ) | (288,920 | ) | 3,239,886 | |||||||
Cash at beginning of period
|
5,618,669 | 5,703,798 | - | |||||||||
Cash at end of period
|
$ | 3,239,886 | $ | 5,414,878 | $ | 3,239,886 | ||||||
Supplemental disclosures of cash flow information:
|
||||||||||||
Cash paid for interest
|
$ | 561 | $ | - | $ | 1,243 | ||||||
Cash paid for taxes
|
$ | - | $ | - | $ | - | ||||||
Supplemental disclosure of non-cash investing and financing activities:
|
||||||||||||
Beneficial conversion feature discount
|
$ | - | $ | - | $ | 372,850 | ||||||
Fair value of warrants issued with debt
|
$ | - | $ | - | $ | 377,150 | ||||||
Fair value of warrants issued with stock
|
$ | - | $ | 318,087 | $ | 5,985,238 | ||||||
Fair value of warrants issued to the placement agent
|
$ | - | $ | 159,044 | $ | 2,170,282 | ||||||
Conversion of notes payable and accrued interest to stock
|
$ | - | $ | - | $ | 981,729 | ||||||
Transfer from liability classification to equity classification
|
$ | - | $ | - | $ | 4,231,324 |
Level 1
|
Level 2
|
Level 3
|
Total
|
|||||||||||||
Derivative liabilities:
|
||||||||||||||||
At March 31, 2013
|
-
|
-
|
$
|
2,240,446
|
$
|
2,240,446
|
||||||||||
At December 31, 2012
|
-
|
-
|
3,574,958
|
3,574,958
|
Lives
|
2013
|
2012
|
|||||||
Office equipment
|
5 years
|
$
|
157,274
|
$
|
156,162
|
||||
Furniture and fixture
|
7 years
|
1,292
|
1,292
|
||||||
Total property and equipment
|
158,566
|
157,454
|
|||||||
Less: accumulated depreciation
|
(154,444
|
)
|
(154,444
|
)
|
|||||
Loss on disposition of equipment
|
(4,122)
|
-
|
|||||||
Property and equipment, net
|
$
|
-
|
$
|
3,010
|
Units
|
Fair Value
|
|||||||
Balance, December 31, 2012
|
5,146,338
|
$ |
3,574,958
|
|||||
Change in fair value
|
-
|
(1,334,512
|
)
|
|||||
Balance, March 31, 2013
|
5,146,338
|
$
|
2,240,446
|
December 31,
|
March 31,
|
|||||
2012
|
2013
|
|||||
Market value of common stock on measurement date (1)
|
$1.17
|
$1.17
|
||||
Adjusted exercise price
|
$0.48 - $0.81
|
$0.78 - $2.475
|
||||
Risk free interest rate (2)
|
$0.10 - $0.77
|
1.24%
|
||||
Warrant lives in years
|
4 months/5 years
|
1 months/4.7 years
|
||||
Expected volatility (3)
|
125% - 161%
|
161%
|
||||
Expected dividend yield (4)
|
-
|
-
|
||||
Probability of stock offering in any period over 5 years (5)
|
25%
|
25% - 40%
|
(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 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% - 40% for each quarter of the next five years.
|
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 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 Actinium 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 Actinium’s current officers or directors had a prior relationship or affiliation with Actinium 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 March 31, 2013.
|
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 March 31, 2013.
|
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 March 31, 2013.
|
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
|
||||||||||||||
Number of |
Average
|
Contractual
|
Intrinsic
|
|||||||||||||
Units
|
Exercise Price
|
Term (in years)
|
Value
|
|||||||||||||
Outstanding, December 31, 2012
|
2,330,134
|
$
|
0.96
|
8.91
|
$
|
685,800
|
||||||||||
Outstanding, March 31, 2013
|
2,330,134
|
$
|
0.96
|
8.66
|
$
|
685,800
|
Weighted
|
||||||||||||||||
Average
|
||||||||||||||||
Weighted
|
Remaining
|
Aggregate
|
||||||||||||||
Number of |
Average
|
Contractual
|
Intrinsic
|
|||||||||||||
Units
|
Exercise Price
|
Term (in years)
|
Value
|
|||||||||||||
Outstanding, December 31, 2012
|
12,770,636
|
0.97
|
4.48
|
6,114,768
|
||||||||||||
Outstanding, March 31, 2013
|
12,770,636
|
$
|
0. 97
|
4.23
|
$
|
6,114,768
|
For the three months ended
March 31,
|
||||||||
2013
|
2012
|
|||||||
Revenues
|
$
|
-
|
$
|
-
|
||||
Operating expenses:
|
||||||||
Research and development, net of reimbursements
|
1,085,707
|
444,886
|
||||||
General and administrative
|
933,135
|
560,276 | ||||||
Other expenses
|
4,122
|
158
|
||||||
Total operating expenses
|
2,022,964
|
1,005,320
|
||||||
Other (income) expense:
|
||||||||
Interest expense
|
575
|
312,890 | ||||||
Gain on change in fair value of derivative liabilities
|
(1,334,512
|
)
|
(409,301
|
)
|
||||
Total other income
|
(1,333,937)
|
(96,411)
|
||||||
Net loss
|
$
|
(689,027
|
)
|
$
|
(908,909
|
)
|
For the three months ended
March 31,
|
||||||||
2013
|
2012
|
|||||||
Cash provided by (used in) operating activities
|
$
|
(2,312,338
|
)
|
$
|
(947,926
|
)
|
||
Cash provided by (used in) investing activities
|
(1,112
|
)
|
(1,157
|
) | ||||
Cash provided by (used in) financing activities
|
(65,333)
|
660,163
|
||||||
Net change in cash
|
$
|
(2,378,783
|
)
|
$
|
(288,920)
|
Exhibit No.
|
Title of Document
|
Location
|
||
31
|
Certification of the Principal Executive Officer and Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
Attached
|
||
32
|
Certification of the Principal Executive Officer and Principal Financial Officer pursuant to U.S.C. Section 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002*
|
Attached
|
||
101.INS
|
X XBRL Instance Document
|
Attached
|
||
101.SCH
|
X XBRL Taxonomy Extension Schema Document
|
Attached
|
||
101.CAL
|
X XBRL Taxonomy Calculation Linkbase Document
|
Attached
|
||
101.DEF
|
X XBRL Taxonomy Extension Definition Linkbase Document
|
Attached
|
||
101.LAB
|
X XBRL Taxonomy Label Linkbase Document
|
Attached
|
||
101.PRE
|
X XBRL Taxonomy Presentation Linkbase Document
|
Attached
|
ACTINIUM PHARMACEUTICALS, INC.
|
|||
Date: May 15, 2013
|
|||
|
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)
|