|
|
|
||
Delaware
|
2834
|
45-2259340
|
||
(State or other jurisdiction of
incorporation or organization)
|
(Primary Standard Industrial
Classification Code Number)
|
(I.R.S. Employer
Identification Number)
|
David N. Feldman, Esq.
Richardson & Patel, LLP
The Chrysler Building
405 Lexington Avenue, 49
th
Floor
New York, NY 10174
(212) 869-7000
(Telephone Number)
(917) 677-8165
(Facsimile Number)
|
Henry I. Rothman, Esq.
Joseph Walsh, Esq.
Troutman Sanders LLP
The Chrysler Building
405 Lexington Avenue
New York, NY 10174
(212) 704-6000
(Telephone Number)
(917) 704-6288
(Facsimile Number)
|
Large accelerated filer
o
|
Accelerated filer
o
|
|
Non-accelerated filer
o
(Do not check if a smaller reporting company)
|
Smaller reporting company
þ
|
Title of each class of securities to be registered
|
Proposed Maximum
Aggregate Offering
Price(1)
|
Amount of
Registration Fee
|
|||||
Common stock, par value $0.0001
per share (2)
|
$ |
12,000,000
|
$ |
1,545.60
|
|||
Common Stock par value $0.0001
per share (3)
|
$ |
200,000
|
$ |
25.76
|
|||
TOTAL
|
$ |
12,200,000
|
$ |
1,571.36
|
(1)
|
Estimated solely for the purpose of calculating the registration fee in accordance with Rule 457(o) of the Securities Act of 1933, as amended (the “Securities Act”), for the public offering and Rule 457(a) of the offering by the security holder.
|
(2)
|
This registration statement covers under one prospectus, the registrant’s initial public offering of up to 2,400,000 shares of the registrant’s common stock, par value $0.0001 per share (the “Common Stock”) (based on an assumed offering price of $5.00 per share).
|
(3)
|
This registration statement also covers, under a separate prospectus,
the resale (the “Resale”) of an aggregate of
40,000
shares of Common Stock owned by
one (1
) selling
shareholder
(the “Security
Holder
”) identified in the Resale Prospectus defined below. The Company will not receive any proceeds from the Resale.
|
|
●
|
Public Offering Prospectus.
A prospectus to be used for the initial public offering by the registrant of 2,400,000 shares of Common Stock, (the “Public Offering Prospectus”) through the placement agents named on the cover page of the Public Offering Prospectus.
|
|
|
●
|
Resale Prospectus.
A prospectus to be used in connection with the potential distribution by the Security Holder of up to an aggregate of 40,000
shares of the registrant’s Common Stock (the “Resale Prospectus”).
|
|
●
|
they contain different front covers;
|
|
|
●
|
they contain different tables of contents;
|
|
|
●
|
the summary of The Offering is deleted from the Resale Prospectus;
|
|
|
●
|
they contain different Use of Proceeds sections;
|
|
|
●
|
a Shares Registered for Distribution section is included in the Resale Prospectus;
|
|
|
●
|
they contain different Plan of Distribution sections;
|
|
|
●
|
the Legal Matters section in the Resale Prospectus deletes the reference to counsel for the placement agents; and
|
|
|
●
|
they contain different back covers.
|
PROSPECTUS | Subject to Completion, Dated , 2014 |
Per Share
|
Total
|
|||||||
Public Offering Price
|
$
|
5.00
|
$
|
12,000,000
|
||||
Placement Agents' Commissions(1)
|
$
|
0.35
|
$
|
840,000
|
||||
Offering Proceeds before expenses (2)
|
$
|
4.65
|
$
|
11,160,000
|
Sunrise Securities Corp. |
Page
|
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23
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24
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26
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27
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28
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29
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36
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62
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64
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66
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68
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70
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71
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72
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73
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74
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77
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80
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80
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80
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80
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●
|
The vaccine will be generated within eight days from a patient’s peripheral blood. We will be able to generate the vaccine quickly because only 200ml of blood is required to be drawn. Leukapheresis, a medical technology in which the blood of a patient is passed through an apparatus -dialysis machine- that separates out one particular constituent and returns the remainder to the circulation which is used in Denderon’s Provenge™ cancer vaccine, is not needed.
|
|
●
|
The vaccine will use an allogenic (using cells, tissues, or organs, sourced from a genetically non-identical member of the same species as the recipient (“Allogenic”) tumor lysate (a fluid containing the contents of lysed cells (lysis referring to the breaking down of a cell and a fluid containing the contents of lysed cells referred to as a “lysate”) as opposed to inconvenient autologous (from the patient) tumor lysate. A major limitation of autologous tumor cell vaccines is the low yield of autologous tumor cells that may compromise the number of immunizations given to patients (difficult to obtain enough cancer cells from the patient). A second inconvenience is the variability of GM-CSF (a protein
that functions as a
white blood cell growth factor
) secretion among patients, which could be responsible for the different levels of responses observed. But above all, although autologous tumor cells may be a good source of tumor-associated antigens, present on some tumor cells and some normal cells (as opposed to tumor specific antigens only present on tumor cells) (TAA) for cancer vaccine development, limitations plus the significant time and expense required for the approval of each patient’s vaccine by the appropriate regulatory agencies severely limits the development of this type of immunization approach. DanDrit does not need a patient’s tumor cells to manufacture MCV. Therefore MCV is not classified as an autologous vaccine.
|
|
●
|
The vaccine will be polytopic (targets several cancer specific antigens). As a result, the risk of the tumor escaping is more limited and more T-cells can be activated than if the vaccine is targeting one antigen only. However, MCV has a focus on
melanoma-associated antigen
(“
MAGE”)-A antigens that are only expressed by tumors and absent in normal tissues.
|
|
●
|
Fast track production in two days is possible.
|
|
●
|
Cutting Edge Technology.
We believe, based on the current state of research, that immunotherapy is one of the waves of the future in cancer management.
|
|
●
|
Colorectal Therapy Potential.
We believe the treatment of advanced colorectal cancer represents an opportunity to meet a well identified medical need for safe maintenance therapy. We believe the clinical data for MCV to date shows the potential for the vaccine to eventually become a standard of care for maintenance therapy. We believe, based on our studies to date, that MCV has the potential to prolong periods of remission after response to chemotherapy. If MCV works as expected in advanced colorectal cancer, we believe it would likely prove beneficial in other tumors that over-express MAGE-A including lung, breast and esophageal cancers.
|
|
●
|
Regulatory Precedent.
With Provenge™, its prostate cancer vaccine, Dendreon pioneered the regulatory pathway for MCV. Dendreon worked with the FDA to develop the protocols which could allow a cellular therapy such as MCV to be approved for clinical use. We believe that DanDrit is the next generation of dendritic cell vaccine with several improvements over its competition:
stimulate a cellular immune response rather than just an antibody response, no need for leukapheresis to produce the vaccine, intradermal administration, convenience of an Allogenic vaccine (off-the-shelf cancer specific antigens), polytopic approach but with a focus on the MAGE-A antigen family and reliable cost-efficient manufacturing.
|
|
●
|
Use in Singapore.
For the last five years, DanDrit and the Singapore National Cancer Center have provided MCV to colorectal cancer patients within an on-going compassionate use program in Singapore.
|
|
●
|
Strong IP Protection.
The technology is patented with a long patent life. DanDrit owns 100% of the technology.
|
|
●
|
audited financial statements are required for only two fiscal years;
|
|
●
|
selected financial data is required for only the fiscal years that were audited;
|
|
●
|
executive compensation only needs to be presented in the limited format now required for “smaller reporting companies”.
|
For the
Three Months
Ended
March 31, 2014
|
For the
Three
Months
Ended
March 31, 2013
|
For the Year
Ended
December 31,
2013
|
For the Year
Ended
December 31,
2012
|
|||||||||||||
(Unaudited) | (Unaudited) | (Audited) | (Audited) | |||||||||||||
Net Sales
|
$ | - | $ | 31,558 | $ | 32,768 | $ | 62,806 | ||||||||
Cost of Goods Sold
|
17,739 | 15,360 | 109,299 | 64,385 | ||||||||||||
Gross Income (Loss)
|
(17,739 | ) | 16,198 | (76,531 | ) | (1,579 | ) | |||||||||
Operating Expenses:
|
||||||||||||||||
General and administrative expenses
|
326,428 | 175,016 | 1,233,683 | 1,036,005 | ||||||||||||
Depreciation and Amortization
|
6,794 | 8,600 | 38,297 | 56,600 | ||||||||||||
Consulting expenses
|
61,145 | 13,048 | 390,437 | 829,845 | ||||||||||||
Total Operating Expense
|
394,367 | 196,664 | 1,662,417 | 1,922,450 | ||||||||||||
Loss from Operations
|
(412,106 | ) | (180,466 | ) | (1,738,948 | ) | (1,924,029 | ) | ||||||||
Other Income (Expense)
|
||||||||||||||||
Interest (expense)
|
(13,999 | ) | (159,922 | ) | (652,703 | ) | (704,911 | ) | ||||||||
Gain (loss) on currency transactions
|
- | (100,327 | ) | 19,541 | 32,841 | |||||||||||
Gain on forgiveness of debt | - | - | 49,016 | - | ||||||||||||
Gain on derivative liability
|
- | 41,643 | 175,732 | 153,430 | ||||||||||||
Gain on sale of assets | - | - | 1 | 15,020 | ||||||||||||
Interest Income
|
51 | - | - | - | ||||||||||||
Total Other Income (Expense)
|
(13,948 | ) | (218,606 | ) | (408,413 | ) | (503,620 | ) | ||||||||
Loss Before Income Taxes
|
(426,054 | ) | (399,072 | ) | (2,147,361 | ) | (2,427,649 | ) | ||||||||
Income Tax Expense (Benefit)
|
- | - | - | - | ||||||||||||
Net Loss
|
$ | (426,054 | ) | $ | (399,072 | ) | $ | (2,147,361 | ) | $ | (2,427,649 | ) |
|
●
|
execute on product candidate development activities;
|
|
●
|
obtain required regulatory approvals for the development and commercialization of our product candidates;
|
|
●
|
maintain, leverage and expand our intellectual property portfolio;
|
|
●
|
gain market acceptance for our products;
|
|
●
|
develop and maintain any strategic relationships we elect to enter into; and;
|
|
●
|
manage our spending as costs and expenses increase due to preclinical development, clinical trials, regulatory approvals and commercialization.
|
|
●
|
Implement preclinical studies (pharmacology, toxicology testing and safety pharmacological evaluations).
|
|
●
|
Provide DanDrit with vaccine materials and support DanDrit’s activities related to preclinical and clinical studies.
|
|
●
|
Implement, inspect and/or monitor some or all aspects of the preclinical or clinical studies with DanDrit’s product candidates.
|
|
●
|
Ensure compliance with regulatory requirements such as Good Clinical Practice (“GCP”), Good Manufacturing Practice (“GMP”) and Good Laboratory Practices (“GLP”).
|
|
●
|
Deliver IT services.
|
|
●
|
Produce vaccine drugs and vaccines in accordance with GMP. The third parties DanDrit depends on may not be available when needed, or might not, if available, comply with all statutory and contractual requirements, and / or otherwise provide their services in a timely manner or in an acceptable manner.
|
|
●
|
The ability of DanDrit or its collaborators to demonstrate the clinical efficacy, safety and benefits of the products.
|
|
●
|
The ability of DanDrit or its collaborators to demonstrate that the product has advantages over existing therapies or new alternative treatments.
|
|
●
|
The frequency and severity of any adverse effects arising from the use of the products.
|
|
●
|
The price of the products.
|
|
●
|
The subsidies DanDrit receives.
|
|
●
|
Efficacy within the therapeutic range for the illnesses the products are directed towards.
|
|
●
|
Patient comfort and user administration.
|
|
●
|
Requirements for marking.
|
|
●
|
The level of support for marketing and distribution.
|
●
|
an annual, nondeductible fee on any entity that manufactures or imports specified branded prescription drugs and biologic agents, apportioned among these entities according to their market share in certain government healthcare programs;
|
●
|
an increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program, to 23.1% and 13.0% of the average manufacturer price for most branded and generic drugs, respectively;
|
●
|
expansion of healthcare fraud and abuse laws, including the False Claims Act and the Anti-Kickback Statute, new government investigative powers, and enhanced penalties for noncompliance;
|
●
|
a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for a manufacturer’s outpatient drugs to be covered under Medicare Part D;
|
●
|
extension of a manufacturer’s Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations;
|
●
|
expansion of eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to additional individuals and by adding new mandatory eligibility categories for certain individuals with income at or below 133% of the federal poverty level beginning in 2014, thereby potentially increasing a manufacturer’s Medicaid rebate liability;
|
●
|
expansion of the entities eligible for discounts under the Public Health Service pharmaceutical pricing program;
|
●
|
new requirements under the federal Open Payments program and its implementing regulations;
|
●
|
a new requirement to annually report drug samples that manufacturers and distributors provide to physicians; and
|
●
|
a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research.
|
•
|
the rate of progress and cost of our clinical studies;
|
•
|
the timing of, and costs involved in, seeking and obtaining approvals from the FDA and other regulatory authorities;
|
•
|
the cost of preparing to manufacture MCV on a larger scale;
|
•
|
the costs of commercialization activities if MCV or any future product candidate is approved, including product sales, marketing, manufacturing and distribution;
|
•
|
the degree and rate of market acceptance of any products launched by us or future partners;
|
•
|
the costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights;
|
•
|
our ability to enter into additional collaboration, licensing, commercialization or other arrangements and the terms and timing of such arrangements;
|
•
|
the emergence of competing technologies or other adverse market developments; and
|
•
|
the costs of attracting, hiring and retaining qualified personnel.
|
|
●
|
Actions taken by regulatory bodies relating to the verification, registration or health effects of our products.
|
|
●
|
The extent to which existing and newly developed products obtain market acceptance.
|
|
●
|
The timing and size of customer purchases.
|
|
●
|
Customer concerns about the stability of our business, which could cause them to seek alternatives to our solutions and products; and
|
|
●
|
Increases in raw material costs.
|
●
|
have an auditor report on our internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act;
|
●
|
comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements (i.e., an auditor discussion and analysis);
|
●
|
submit certain executive compensation matters to shareholder advisory votes, such as “say-on-pay”, “say-on-frequency” and “say-on-golden parachute;” and
|
●
|
disclose certain executive compensation related items such as the correlation between executive compensation and performance and comparisons of the Chief Executive’s compensation to median employee compensation.
|
|
●
|
future financial and operating results, including projections of revenues, income, expenditures, cash balances and other financial items;
|
|
●
|
our capital requirements and the need for additional financing;
|
|
●
|
our ability to protect our intellectual property rights and secure the right to use other intellectual property that we deem to be essential to the conduct of our business;
|
|
●
|
our ability to execute our growth, expansion and acquisition strategies;
|
|
●
|
current and future economic and political conditions;
|
|
●
|
overall industry and market performance;
|
|
●
|
competition;
|
|
●
|
management’s goals and plans for future operations; and
|
|
●
|
other assumptions described in this prospectus underlying or relating to any forward-looking statements.
|
●
|
the existence of unforeseen or other opportunities or the need to take advantage of changes in the timing of our existing activities;
|
●
|
the need or desire on our part to accelerate, increase, reduce, change or eliminate one or more existing initiatives due to, among other things, changing market conditions and competitive developments or interim results of research and development efforts;
|
●
|
results from our business development and marketing efforts, including opportunities that may materialize;
|
●
|
the effect of federal, state, and local regulation on us and on our identified industries;
|
●
|
our ability to attract development funding or to license or sell our vaccine candidates;
|
●
|
the presentation of strategic opportunities of which we are not currently aware (including acquisitions, joint ventures, licensing and other similar transactions); and/or
|
●
|
the filing of a post-effective amendment pursuant to Rule 462(b) of the Securities Act in order to raise additional funds to strengthen our Phase II/III clinical trial with a larger sample size and target patients with stage III colorectal cancer rather than metastatic (stage IV) colorectal cancer patients.
|
|
●
|
any contractual restrictions limiting our ability to pay dividends that may be applicable at such time;
|
|
●
|
our earnings and cash flow;
|
|
●
|
our capital requirements;
|
|
●
|
our financial condition; and
|
|
●
|
other factors our board of directors deems relevant.
|
As of March 31,
2014
|
||||
Unaudited | ||||
Cash and cash held in escrow
|
$ | 559,774 | ||
Notes payable - related party, current portion
|
1,705,201 | |||
Accounts payable and accrued liabilities
|
1,392,367 | |||
Total Debt obligations and payables
|
3,097,568 | |||
STOCKHOLDERS’ DEFICIT:
|
||||
Common stock; par value $0.0001, 100,000,000 shares authorized, 8,040,000, 9,054,947 and 10,254,947 shares issued and outstanding respectively (1)
|
804
|
|||
Additional Paid-in Capital
|
17,788,110 | |||
Other Comprehensive Income, net
|
(27,836 | ) | ||
Accumulated Deficit
|
(19,947,180 | ) | ||
Total Stockholders’ (Deficit)
|
(2,186,102 | ) | ||
Total Capitalization
|
$ | 911,466 |
For The
Three Months
Ended
March 31, 2014
|
For The
Three Months
Ended
March 31, 2013
|
|||||||
Revenues
|
$
|
-
|
$
|
31,558
|
||||
Cost of Goods Sold
|
17,739
|
15,360
|
||||||
Gross Income(Loss)
|
(17,739
|
) |
16,198
|
|||||
Operating Expenses
|
||||||||
General and Administrative Expenses
|
326,428
|
175,016
|
||||||
Depreciation and Amortization
|
6,794
|
8,600
|
||||||
Consulting Expenses
|
61,145
|
13,048
|
||||||
Total Operating Expense
|
394,367
|
196,664
|
||||||
(LOSS) FROM OPERATIONS
|
(412,106
|
)
|
(180,466
|
) | ||||
Other Income (Expense)
|
||||||||
Interest (expense)
|
(13,999
|
) |
(159,922
|
)
|
||||
Gain (loss) on Currency Transactions
|
-
|
(100,327
|
) | |||||
Gain on Derivative Liability
|
-
|
41,643
|
||||||
Interest Income
|
51
|
-
|
||||||
Total Other Income (Expense)
|
(13,948
|
)
|
(218,606
|
) | ||||
(Loss) Before Income Taxes
|
(426,054
|
) |
(399,072
|
) | ||||
Income Tax Expense (Benefit)
|
-
|
-
|
||||||
NET (LOSS)
|
$
|
(426,054
|
) |
$
|
(399,072
|
) | ||
BASIC AND DILUTED LOSS PER SHARE
|
$
|
(0.06
|
) |
(0.08
|
) | |||
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING - BASIC AND DILUTED
|
7,065,333
|
5,318,151
|
For the Year Ended
December 31,
|
||||||||
2013
|
2012
|
|||||||
Net Sales
|
$
|
32,768
|
$
|
62,806
|
||||
Cost of Goods Sold
|
102,299
|
64,385
|
||||||
Gross Loss
|
(76,531
|
)
|
(1,579
|
) | ||||
Operating Expenses:
|
||||||||
General and administrative expenses
|
1,233,683
|
1,036,005
|
||||||
Depreciation and Amortization
|
38,297
|
56,600
|
||||||
Consulting expenses
|
390,437
|
829,845
|
||||||
Total Operating Expense
|
1,662,417
|
1,922,450
|
||||||
Loss from Operations
|
(1,738,948
|
)
|
(1,924,029
|
)
|
||||
Other Income (Expense)
|
||||||||
Interest (expense)
|
(652,703
|
) |
(704,911
|
)
|
||||
Gain on forgiveness of debt
|
49,016
|
-
|
||||||
Gain (loss) on currency transactions
|
19,541
|
32,841
|
||||||
Gain on derivative liability
|
175,732
|
153,430
|
||||||
Gain on sale of fixed assets
|
1
|
15,020
|
||||||
-
|
||||||||
Total Other Income (Expense)
|
(408,413
|
)
|
(503,620
|
)
|
||||
Loss Before Income Taxes
|
(2,147,361
|
)
|
(2,427,649
|
)
|
||||
Income Tax Expense (Benefit)
|
-
|
|||||||
Net Loss
|
(2,147,361
|
)
|
(2,427,649
|
)
|
||||
BASIC AND DILUTED LOSS PER SHARE
|
$ |
(0.40
|
) | $ |
(0.46
|
) | ||
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING - BASIC AND DILUTED
|
5,332,721
|
5,318,151
|
Three Months
Ended
March 31, 2014
|
Three Months
Ended
March 31, 2013
|
|||||||
Net Cash (Used by) Operating Activities
|
$
|
(437,746
|
)
|
$
|
(1,123,899
|
) | ||
Net Cash (Used by) Investing Activities
|
(395,906
|
) |
-
|
|||||
Net Cash Provided by Financing Activities
|
$
|
865,976
|
$
|
987,911
|
||||
Loss on Currency Translation
|
3,354
|
139,279
|
||||||
Net Increase (Decrease) in Cash and Cash Equivalents
|
$
|
35,678
|
$
|
3,291
|
|
●
|
The vaccine will be generated within eight days from a patient’s peripheral blood. We will be able to generate the vaccine quickly because only 200ml of blood is required to be drawn. Leukapheresis (a medical technology in which the blood of a patient is passed through an apparatus -dialysis machine- that separates out one particular constituent and returns the remainder to the circulation which is used in Denderon’s Provenge™ cancer vaccine) is not needed.
|
|
●
|
The vaccine will use an allogenic (using cells, tissues, or organs, sourced from a genetically non-identical member of the same species as the recipient (“Allogenic”) tumor lysate (a fluid containing the contents of lysed cells, cells broken down by viral, enzymic or osmotic mechanisms that compromise their integrity “lysed cells”) as opposed to inconvenient autologous (from the patient) tumor lysate.
A major limitation of autologous tumor cell vaccines is the low yield of autologous tumor cells that may compromise the number of immunizations given to patients (difficult to obtain enough cancer cells from the patient). A second inconvenience is the variability of GM-CSF (a protein
that functions as a
white blood cell growth factor
)
secretion among patients, which could be responsible for the different levels of responses observed. But above all, although autologous tumor cells may be a good source of TAA for cancer vaccine development, limitations plus the significant time and expense required for the approval of each patient’s vaccine by the appropriate regulatory agencies severely limits the development of this type of immunization approach.
DanDrit does not need a patient’s tumor cells to manufacture MCV. Therefore MCV is not classified as an autologous vaccine.
|
|
●
|
The vaccine will be polytopic (targets several cancer specific
antigens
, or
antibody generator
is any substance which provokes an adaptive immune response “antigens”
).
As a result
, the risk of the tumor escaping is more limited and more T-cells can be activated than if the vaccine is targeting one antigen only. However, MCV has a focus on
melanoma-associated antigen (“
MAGE”)-A antigens that are only expressed by tumors and absent in normal tissues.
|
|
●
|
Fast track production in two days is possible.
|
·
|
Generation of fast track dendritic cells
|
·
|
Processing and presentation of protein antigen
|
·
|
Characterization of DanDrit dendritic cells
|
·
|
Analysis of lysate uptake by DanDrit dendritic cells
|
·
|
MicroRNA profiling of DanDrit dendritic cells
|
·
|
Effect of Resiquimod (
a drug that acts as an immune response modifier, and has
antiviral
and
anti-tumor
al
activity)
on production of Interleukin 12 (Il-12), a secreted protein factor that is naturally produced by dendritic cells in response to antigenic stimulation and Interleukin 10 (IL-10), a protein that inhibits the synthesis of a number of other signaling proteins.
|
·
|
Generation of tolerogenic dendritic cells
|
·
|
Development of Il-12 based potency assay
|
|
●
|
Autologous dendritic cells obtained by the activation of patient-derived monocytes
|
|
●
|
Proprietary lysate from melanoma-derived cell line expressing a range of cancer/testis antigens, notably the MAGE-A family
|
|
●
|
Phase II at Gentofte Hospital, Denmark – Completed, November 2004 – April 2006
|
|
●
|
Phase II at the National Cancer Centre, Singapore – Completed, November 2005 – March 2007
|
|
●
|
Phase II at Herlev Hospital, Denmark – Completed, January 2006 – September 2009
|
|
●
|
Age 25-75
|
|
●
|
No chemo or radiotherapy within six weeks prior to inclusion
|
|
●
|
Expected survival > four month
|
|
●
|
Performance status two according to the performing status of WHO
|
|
●
|
Adequate hepatic and renal function
|
|
●
|
Adequate haematopoietic and coagulation capacity
|
|
●
|
Normal EKG or non-clinical significant abnormal EKG
|
|
●
|
Preserved pulmonary function
|
|
●
|
Uncontrolled serious infection
|
|
●
|
Systemic corticosteroid treatment or other immune suppressive treatment in the last two months
|
|
●
|
Participation in other clinical trials over the former six weeks
|
|
●
|
For women, pregnancy or lactation
|
·
|
vitality
|
·
|
physical functioning
|
·
|
bodily pain
|
·
|
general health perceptions
|
·
|
physical role functioning
|
·
|
emotional role functioning
|
·
|
social role functioning
|
·
|
mental health
|
ID
|
Age
(years) |
Sex
|
PS
|
Site of disease
|
No. of
Chemo-regimens |
Disease at Accrual
|
No. of vaccinations
|
BOR
|
Time to Tumor response (months)
|
Duration of response (months)
|
TTP
(months) |
Survival Time (months)
|
||||||||||||||
1 | 72 | F | 1 |
LN
|
1 |
PD
|
10 |
SD
|
2.7 |
> 25.0
*
|
> 27.7
*
|
39.7 | † | |||||||||||||
2 | 67 | F | 1 |
Lung
|
0 |
PD
|
10 |
SD
|
2.9 | 4.2 | 7.1 | 35.6 | ||||||||||||||
3 | 53 | F | 2 |
Lung, LN, Pelvic, Bone
|
4 |
PD
|
10 |
SD
|
1.7 | 5.2 | 6.9 | 6.9 | ||||||||||||||
4 | 43 | F | 1 |
Lung, Adrenal, LN
|
4 |
PD
|
3 |
PD
|
- | - | 2.6 | 5.9 | ||||||||||||||
5 | 54 | M | 1 |
Liver, Lung, Ascites, LN
|
3 |
PD
|
3 |
ND
‡
|
- | - |
> 3.8
‡
|
3.8 | ‡ | |||||||||||||
6 | 76 | M | 0 |
Liver, Peritoneum, Pelvic, Lung, LN, Serosa
|
3 |
PD
|
10 |
SD
|
1.8 | 2.4 | 4.1 | 7.6 | ||||||||||||||
7 | 33 | F | 1 |
Bone
|
2 |
PD
|
9 |
PD
|
- | - | 2.0 | 6.5 | ||||||||||||||
8 | 75 | F | 0 |
Lung
|
0 |
PD
|
10 |
PD
|
- | - | 1.9 | 13.1 | ||||||||||||||
9 | 62 | F | 1 |
LN, Lung and Pelvic
|
3 |
PD
|
10 |
PR
|
2.5 |
> 35.4
*
|
> 37.9
*
|
37.9 | † | |||||||||||||
10 | 73 | M | 0 |
Liver, LN
|
2 |
PD
|
10 |
PD
|
- | - | 2.1 | 19.6 | ||||||||||||||
11 | 64 | M | 0 |
Liver
|
1 |
PD
|
10 |
PD
|
- | - | 2.1 | 6.4 | ||||||||||||||
12 | 57 | M | 1 |
Lung, Liver, LN
|
2 |
PD
|
10 |
PD
|
- | - | 2.3 | 7.5 | ||||||||||||||
13 | 65 | F | 1 |
LN, Pleural, Lung, Liver
|
5 |
PD
|
5 |
PD
|
- | - | 1.6 | 2.9 | ||||||||||||||
14 | 49 | M | 1 |
Lung, Liver, Peritoneum
|
5 |
PD
|
8 |
SD
|
2.3 | 1.2 | 3.5 | 7.2 | ||||||||||||||
15 | 72 | M | 0 |
LN, Pleural, Liver, Lung
|
2 |
PD
|
4 |
PD
|
- | - | 1.8 | 3.2 | ||||||||||||||
16 | 77 | M | 1 |
Liver, Bone, Lung
|
4 |
PD
|
10 |
SD
|
1.6 | 1.9 | 3.5 | 13.0 | ||||||||||||||
17 | 75 | F | 0 |
Lung, Liver
|
1 |
PD
|
10 |
PD
|
- | - | 1.9 | 17.5 | ||||||||||||||
18 | 54 | F | 0 |
LN, Lung
|
1 |
PD
|
10 |
SD
|
1.8 | 4.9 | 6.7 | 23.2 | ||||||||||||||
19 | 75 | M | 0 |
Lung, Liver,
|
2 |
PD
|
3 |
PD
|
- | - | 2.0 | 2.9 | ||||||||||||||
20 | 41 | F | 1 |
Lung, Skin, LN, Bone
|
5 |
PD
|
6 |
PD
|
- | - | 1.9 | 4.5 |
ECOG PERFORMANCE STATUS
|
||
Grade
|
ECOG
|
|
0
|
Fully active, able to carry on all pre-disease performance without restriction
|
|
1
|
Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work
|
|
2
|
Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours
|
|
3
|
Capable of only limited self-care, confined to bed or chair more than 50% of waking hours
|
|
4
|
Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair
|
|
5
|
Dead
|
●
|
The vaccine could then be mass-produced in a unique manufacturing facility
|
||
● |
Cost effective process
|
||
● |
All manufacturing process can then be out-sourced (DanDrit does not need to support its own GMP manufacturing facility)
|
||
● |
The MCV2 vaccine could be more likely to have higher potential efficacy than MCV. The allogeneic DCs are further regarded as MHC-incompatible foreign invaders. Then, they induce an inflammatory reaction that further promotes the recruitment and activation of endogenous DCs at the vaccination site. This hypothesis has now been verified in rat and mouse cancer models in which tumor growth was significantly reduced by therapeutic vaccinations with tumor-loaded allogeneic DCs.
|
|
●
|
MCV2 is still using the clinically proven lysate used in MCV as cancer specific antigen
|
|
●
|
“One- To- Many”: the same drug product could be used to treat several patients (consistent with current pharma business model).
|
|
●
|
Fully standardizable product
|
|
●
|
Guarantee of homogeneity of the clinical trials
|
Purpose
|
To determine the safety and efficacy of our investigational vaccine in colorectal cancer and to determine its ability to prevent recidive in stage IV colorectal patients with no evidence of disease (after surgical resection of metastase and chemotherapy)
|
Study Type
|
Interventional
|
Study design
|
|
Endpoint (primary)
|
Efficacy : Progression Free Survival at 18 months
|
Endpoint (secondary)
|
Overall Survival; Carcino-Embryonic Antigen (CEA); Quality of Life
|
Intervention Model
|
Parallel assignment 174 patients
|
Masking
|
Double blind
|
Allocation
|
Randomized
|
Power
|
80%
|
Adaptive Design
|
Purpose:
seamless Phase II/III clinical trial
|
Treatment
|
Five vaccines bi-weekly (intra-dermal administration) followed by ten vaccines every two months
|
Location
|
Asia, Europe, and USA
|
Expected Duration
|
Three years
|
Eligibility
|
Stage IV colorectal cancer patients
After resection of metastase and no evidence of disease (CT scan and CEA back to normal)
●
Stratification for risk factor
Vaccine therapy given after FOLFOX or FOLFIRI (after completion of course of chemotherapy)
Screen for
MAGE-A expression
|
|
●
|
Patient accrual and site selection
|
|
●
|
Assessment of patient response
|
|
●
|
Study design and collection of patient data
|
|
●
|
Vaccine supply
|
|
●
|
Patient safety
|
|
●
|
Multinational regulatory requirements
|
|
●
|
CRO previous experience
|
|
●
|
Adaptive trial design experience
|
|
●
|
Regulatory review of pertinent data
|
|
●
|
Discussions/kick off meeting with DanDrit contact(s), for background, pertinent issues, proposed questions, strategic discussion etc.
|
|
●
|
Prepare a briefing package for Scientific Advice includes QC (one review round with DanDrit) using the existing information in the Investigational Medicinal Product Dossier(IMPD)/Investigator Brochure(IB) as the basis for the package
|
|
●
|
Set up and attend meeting with EU regulatory agency and conduct all associated administrative tasks (letters, post meeting minutes, etc.)
|
|
●
|
Cutting Edge Technology.
Immunotherapy is one of the waves of the future in cancer treatment.
|
|
●
|
Colorectal Market Potential.
Colorectal cancer is a large market with a well identified unmet medical need for safe maintenance therapy. The clinical data for MCV to date gives the potential for the vaccine to eventually become the standard of care for maintenance therapy. MCV has the potential to alter the treatment paradigm by prolonging periods of remission after response to chemotherapy. If MCV works as expected in colorectal cancer, we believe it would likely prove beneficial in other tumors that over-express MAGE-A including lung, breast and esophageal cancer.
|
|
●
|
Regulatory Precedent.
Dendreon with Provenge™, its prostate cancer vaccine, pioneered the regulatory pathway for MCV. Dendreon worked with the FDA to develop the protocols allowing a cellular therapy such as MCV to be approved for clinical use. DanDrit could be the next generation of dendritic cell vaccine with several improvements over its competition: stimulate a cellular immune response rather than just an antibody response, no need for leukapheresis to produce the vaccine, intradermal administration, convenience of an allogeneic vaccine, polytopic approach but with a focus on the MAGE-A antigen family and reliable manufacturing.
|
|
●
|
Successful Use in Singapore.
For the last five years, DanDrit and the Singapore National Cancer Center have provided MCV to colorectal cancer patients within an on-going compassionate use program in Singapore. Based on that experience, DanDrit is building a potential collaboration with a Chinese oncology pharma partner that may speed up large scale commercialization of MCV.
|
|
●
|
Strong IP Protection.
The technology is patented with a long patent life. DanDrit owns 100% of the technology, without intellectual property issues.
|
|
●
|
For registration, the clinical trial can only be performed in sites approved by the China Food and Drug Administration. By November 2010, there were 112 oncology sites in Mainland China.
|
|
●
|
Screening for MAGE-A could be attractive to the China Food and Drug Administration, but tumor samples could not be shipped outside of China for genomic testing. Therefore a partner who can perform MAGE-A screening in China is valuable.
|
|
●
|
Usually only one pivotal study is required
|
|
●
|
With only 100 to 800 patients (most likely 300 patients)
|
|
●
|
An open-label study design is accepted (without placebo control)
|
|
●
|
The statistical consideration are also attractive as relatively low statistical significance (P value 0.03~0.05) is required
|
|
●
|
Overall additional flexibility exists for oncology drugs, driven by the benefit/risk ratio
|
|
●
|
There is an unprecedented number of anti-cancer therapies in development and the standard of care changes quickly
|
|
●
|
The complexity of information concerning tumor genetics and signaling pathways is growing and will bring greater opportunities for personalized medicine
|
Region
|
Population
1000,000s |
All Cancer
1000s |
NSCLC
1000s |
CRC
1000s
|
Breast
1000s
|
Prostate
1000s
|
Pancreas
1000s
|
USA
|
300
|
1400 (560)
|
190 (125)
|
150 (50)
|
185 (40)
|
185 (30)
|
37 (30)
|
EU
|
500
|
2300 (900)
|
315 (205)
|
250 (85)
|
305 (67)
|
305 (50)
|
60 (50)
|
Combined
|
800
|
3700 (1300)
|
505 (330)
|
400 (135)
|
490 (107)
|
490 (80)
|
97 (80)
|
|
●
|
Pharmaceutical composition for inducing an immune response in a human or animal (2001 Denmark (DK), 2002 PCT)
This patent was first filed in November 2002. The patent covers and describes the usage of an allogeneic melanoma cell lysate (MCL)-pulsed autologous DC vaccine expressing at least one of six MAGE-A antigens overexpressed by the cell line being the source of the lysate. The patent covers the antigen composition used in the generation of MelCancerVac and the claims for producing MelCancerVac. In this patent the antigens are specified to mainly belong to the cancer testis family. The family of antigens is expressed in a wide variety of cancer forms. In the International Preliminary Report on Patentability (IPRP) all claims were determined to be novel and inventive. The patent expiry date is November 29, 2022. This patent has been granted in: Europe, the USA, China, Australia, Singapore, Japan, Russia, Hong Kong. This patent is pending in: Israel and Norway. This patent is owned by the Company and was not licensed from third parties. The patent protection means that the cancer specific antigen-rich lysate obtained from our cell line cannot be commercially made, used, distributed or sold without DanDrit's consent
.
These patent rights can be usually enforced in a court, which, in most systems, holds the authority to stop patent infringement
.
|
|
●
|
Protocol for generating dendritic cells (2005 DK, 2008 PCT)
This patent covers the generation of dendritic cells based on a blood sample of 200 ml. The patent differs from other DC generating patents by the utilization of reduced temperature and a single blood sample. DCs exposed to tumor antigens followed by treatment with T(h)1-polarizing differentiation signals have paved the way for the development of DC-based cancer vaccines. Critical parameters for generation of optimal functional clinical grade DCs are a very competitive area. DanDrit has developed a method that covers the generation of immature dendritic cells under reduced temperature settings which by further activation has been shown to give a high yield of homogeneous and fully matured DCs. This patent was filed on December 7, 2006. In the International Preliminary Report on Patentability (IPRP) a large majority of claims were found to be novel and inventive. The patent expiry date is 2032. This patent was granted in 2012 in China, Eurasia, Russia, Europe, Israel, Mexico, Malaysia, New Zealand. This patent is owned by DanDrit and was not licensed from third parties.
The patent protection means that the method that DanDrit use to generate dendritic cells cannot be commercially
used, distributed or sold
without DanDrit's
consent
.
These
patent
rights
can be usually enforced in a court, which, in most systems, holds the authority to stop
patent infringement
.
|
|
●
|
Method for generating tolerogenic dendritic cells employing decreased temperature (2007)
DanDrit has expanded the method of development of mature dendritic cells to also include the generation of regulatory DCs. In addition to DCs used for cancer immunotherapy, DanDrit has developed an additional arm of DCs, namely regulatory/tolerogenic DCs to be used for treatment of various autoimmune diseases such as Type 1 diabetes and Multiple Sclerosis. This patent was filed on November 13, 2008. Patent pending: worldwide. 1
st
Office Action received in Europe August 25, 2010. This patent is owned by the Company and was not licensed from third parties.
The patent protection means that the method that DanDrit use to produce tolerogenic dendritic cells cannot be commercially
used, distributed or sold
without DanDrit's
consent
.
These
patent
rights
can be usually enforced in a court, which, in most systems, holds the authority to stop
patent infringement
.
|
|
●
|
Micro RNAs as markers of the functional state of a dendritic cell
This patent covers and demonstrates that functionally different DCs carry unique microRNA signatures. By examining a handful of microRNA profiles one can analyze the function of DC vaccines. This is a valuable addition to other vaccine quality control measures that are currently used in studies that involve DCs. Critical parameters for assessment of the optimal functional state of DCs and prediction of the vaccine potency of activated DCs have in the past been based on measurements of differentiation surface markers like HLA-DR, CD80, CD83, CD86, and CCR7 and the level of secreted cytokines like interleukin-12p70. However, the level of these markers does not provide a complete picture of the DC phenotype and may be insufficient for prediction of clinical outcome for DC-based therapy. We have identified additional biomarkers by investigating the differential expression of microRNAs (miRNAs) in mature DCs relative to immature DCs. The patent was filed on November 14, 2008. In the International Preliminary Report on Patentability, a large majority of claims were found to be novel and inventive. Patent pending: Europe and USA. 1
st
Office Action received in Europe on August 18, 2010. Follow up action on election restriction received in the USA on October 21, 2010. This patent is owned by the Company and was not licensed from third parties.
The patent protection means that the method that DanDrit use to test and release its dendritic cells cannot be commercially
used, distributed or sold
without DanDrit's
consent.
These
patent
rights
can be usually enforced in a court, which, in most systems, holds the authority to stop
patent infringement
.
|
|
●
|
at the time of disclosure was already known to the recipient as evidenced by written record pre-dating such disclosure;
|
|
●
|
at the time of disclosure is generally available to the public or subsequently becomes available to the public other than by an act of omission on the part of the recipient; or
|
|
●
|
shall be made available to the recipient (on a non-confidential basis) by a third party having the lawful right to do so.
|
|
●
|
Bavarian Nordic (“BN”): CV-301, BN’s second compound, is in clinical development with advanced colorectal cancer patients
|
|
●
|
Immatics: its second compound is in clinical development in early stage colorectal cancer patients
|
|
●
|
Agenus (www.agenus.com)
|
|
●
|
Argos Therapeutics (
www.argostherapeutics.com
)
|
|
●
|
BioVest (
www.biovest.com
)
|
|
●
|
Celldex (
www.celldextherapeutics.com
)
|
|
●
|
ImmunoCellular Therapeutics Ltd
(www.imuc.com)
|
|
●
|
North West Biotherapeutics (
www.nwbio.com
)
|
|
●
|
Prima Biomed (
www.primabiomed.com.au
)
|
|
●
|
TVax Biomedical (
www.tvax.com
)
|
Name
|
|
Age
|
|
Titles
|
Dr. Eric Leire
|
|
56
|
|
Chief Executive Officer, President and Director (Principal Executive Officer)
|
Robert E. Wolfe
|
|
51
|
|
Chief Financial Officer, Treasurer, Secretary and Director (Principal Financial and Accounting Officer)
|
NE Nielsen
|
|
65
|
|
Chairman of the Board
|
Dr. Jacob Rosenberg
|
|
49
|
|
Director
|
Aldo Michael Noes Petersen
|
|
52
|
|
Director
|
Name and
Principal
|
Year
|
Salary
($)
|
Bonus
($)
|
Stock
Awards
($)
|
Option
Awards
($) |
Nonequity
Incentive Plan
Compensation
|
Nonqualified Deferred Compensation
Earnings
|
Other |
Total
($) (1) |
||||||||||||||||||
Dr. Eric Leire,
|
2013
|
308,471
|
-
|
-
|
-
|
-
|
-
|
-
|
308,471
|
||||||||||||||||||
CEO and Director
|
2012
|
171,938
|
-
|
-
|
-
|
-
|
-
|
-
|
171,938
|
||||||||||||||||||
Dina Rosenberg Asmussen,
|
2013
|
165,746
|
165,746
|
||||||||||||||||||||||||
Former CFO
|
2012
|
162,357
|
-
|
-
|
-
|
-
|
-
|
-
|
162,357
|
Shares in
|
% of shares in
|
|||||||
DanDrit
|
DanDrit
|
|||||||
Biotech
|
Biotech
|
|||||||
Name of Beneficial Owner
|
USA, Inc.
(1)
|
USA, Inc. (1)
|
||||||
Directors/Officers:
|
||||||||
Eric Jean Marie Leire(2)
|
8,615 | 0.11 | % | |||||
Robert E. Wolfe
|
- | - | ||||||
NE Nielsen(3)
|
- | - | ||||||
Dr. Jacob Rosenberg(4)
|
31,476 | 0.39 | % | |||||
Aldo Petersen
|
- | - | ||||||
Directors/Officers Total
:
|
40,091 | 0.50 | % | |||||
5% Shareholders:
|
||||||||
Sune Olsen Holdings ApS(5)
|
777,588 | 9.67 | % | |||||
Media-Invest Danmark A/S(6)
|
793,923 | 9.87 | % | |||||
Bele Invest ApS(7)
|
486,677 | 6.05 | % | |||||
Jonas Petterson (7)
|
486,677 | 6.05 | % | |||||
Sune Olsen (5)
|
1,157,500 | 14.40 | % | |||||
Thomas Ulletved Rasmussen (6)
|
793,923 | 9.87 | % | |||||
DKTI A/S (8)
|
555,869 | 6.91 | % | |||||
NLBDIT 2010 Services, LLC (9)
|
600,000 | 7.46 | % | |||||
5% Shareholders Total
:
|
5,652,157 | 70.30 | % | |||||
Total:
|
5,732,339 | 71.30 | % |
(1)
|
Based on 8,040,000 shares issued as of March 31, 2014, following the Share Exchange
including 185,053 shares of common stock reserved for issuance to the non-consenting shareholders of DanDrit Denmark and
deemed issued and outstanding for accounting purposes
.
|
(2)
|
The holder has an address of Hambros Alle 12, 2900 Hellerup, Denmark.
|
(3)
|
The holder has an address of Lett Law Firm, Raadhuspladsen 4, DK-1550 Copenhagen, Denmark.
|
(4)
|
Shares are owned by Jaro Holding ApS, a Danish entity with an address of C.F. Richs Vej 44, 2000 Frederiksberg Denmark. The voting and disposition of the shares owned by the company are controlled by Dr. Rosenberg.
|
(5)
|
Shares are owned by Sune Olsen Holding ApS, Biotech Invest ApS and Sardinian Solar Park ApS, all Danish entities with an address of Jagtvej 169 B 4, 2100 Copenhagen, Denmark. The voting and disposition of the shares owned by the companies are controlled by Mr. Olsen.
|
(6)
|
Shares are owned by Media-Invest Danmark ApS (“Media-Invest”), a Danish entity with an address of Ostergade 61 4, 1100 Copenhagen, Denmark. The voting and disposition of the shares owned by Media-Invest are controlled by Mr. Rasmussen.
|
(7)
|
Shares are owned by Bele Invest ApS (“Bele Invest”), a Danish entity with an address of Vermehrensvej 7, 2930 Klampenborg Denmark. The voting and disposition of the shares owned by Bele Invest are controlled by Mr. Petterson.
|
(8)
|
DKTI A/S is a Danish public limited liability company with an address of Frederiksgade 21 1, 1265 Copenhagen, Denmark. DKTI was, until September 19, 2013, listed at the stock exchange OMX Nasdaq Copenhagen. DKTI has 189 shareholders. Dr. Eric Leire as CEO of DKTI A/S has voting and dispositive power over the shares owned by DKTI A/S.
|
(9)
|
NLBDIT 2010 Services, LLC (“NLBDIT”) has an address of c/o Sunrise Securities Corp., 600 Lexington Avenue, 23
rd
Floor, New York, NY 10022. The voting and disposition of the shares owned by NLBDIT are controlled by Nathan Low, principal of Sunrise Securities Corp., one of the Placement Agents.
|
●
|
any breach of the director’s duty of loyalty to the corporation or its stockholders;
|
●
|
acts or omissions not in good faith or which involve intentional misconduct or a knowing violation of law;
|
●
|
payments of unlawful dividends or unlawful stock repurchases or redemptions; or
|
●
|
any transaction from which the director derived an improper personal benefit.
|
●
|
the issuer of the securities that was formerly a shell company has ceased to be a shell company;
|
●
|
the issuer of the securities is subject to the reporting requirements of Section 13 or 15(d) of the Exchange Act;
|
●
|
the issuer of the securities has filed all Exchange Act reports and materials required to be filed, as applicable, during the preceding 12 months (or such shorter period that the issuer was required to file such reports and materials), other than Form 8-K reports; and
|
●
|
at least one year has elapsed from the time that the issuer filed current Form 10 type information with the SEC reflecting its status as an entity that is not a shell company.
|
Per Share
|
Total
|
|||||||
Public offering price
|
$
|
5.00
|
$
|
12,000,000
|
||||
Commissions
|
0.35
|
840,000
|
||||||
Proceeds, before expenses, to us
|
4.65
|
11,160,000
|
(i)
|
as a bona fide gift or gifts; or
|
(ii)
|
to any trust for the direct or indirect benefit of the undersigned or the immediate family of the transferring party; or
|
(iii)
|
to the transferring party and/or any member of the immediate family of the transferring party from or by a grantor retained (or like-kind) annuity trust which exists as of the date hereof and was established for the direct or indirect benefit of the transferring party and/or any member of the immediate family of the transferring party pursuant to the terms of such trust;
|
(iv)
|
if the transferring party is a corporation, partnership or other business entity (A) to another corporation, partnership or other business entity that is an affiliate (as defined under Rule 12b-2 of the Exchange Act) of the transferring party or (B) any distribution or dividend to equity holders of the transferring party as part of a distribution or dividend by the transferring party (including upon the liquidation and dissolution of the transferring party pursuant to a plan of liquidation approved by the transferring party 's equity holders), or if the transferring party is a trust, to a grantor or beneficiary of the trust;
|
(v)
|
in the event of a default under a pledge which exists as of the date hereof as security for a margin or loan account pursuant to the terms of such account;
|
(vi)
|
pursuant to any 10b5-l trading plans in effect as of the date of the Offering; or
|
|
(vii)
|
with the prior written consent of Sunrise Securities Corp., as representative of the Placement Agents.
|
(a)
|
to legal entities which are authorized or regulated to operate in the financial markets or, if not so authorized or regulated, whose corporate purpose is solely to invest in securities;
|
(b)
|
to any legal entity which has two or more of (1) an average of at least 250 employees during the last financial year; (2) a total balance sheet of more than €43,000,000 and (3) an annual net turnover of more than €50,000,000, as shown in its last annual or consolidated accounts;
|
(c)
|
by the Placement Agents to fewer than 100 natural or legal persons (other than qualified investors as defined in the Prospectus Directive); or
|
(d)
|
in any other circumstances falling within Article 3(2) of the Prospectus Directive, provided that no such offer of shares shall result in a requirement for the publication by the issuer or the Placement Agents of a prospectus pursuant to Article 3 of the Prospectus Directive.
|
(a)
|
it has only communicated or caused to be communicated and will only communicate or cause to be communicated any invitation or inducement to engage in investment activity (within the meaning of section 21 of the Financial Services and Markets Act 2000 (the FSMA)) received by it in connection with the issue or sale of any of our securities in circumstances in which section 21(1) of the FSMA does not apply to the issuer; and
|
(b)
|
it has complied with and will comply with all applicable provisions of the FSMA with respect to anything done by it in relation to our securities in, from or otherwise involving the United Kingdom.
|
●
|
to legal entities which are authorized or regulated to operate in the financial markets or, if not so authorized or regulated, whose corporate purpose is solely to invest in securities;
|
●
|
to any legal entity which has two or more of (1) an average of at least 250 employees during the last financial year; (2) a total balance sheet of more than 43,000,000 euros; and (3) an annual net turnover of more than 50,000,000 euros, as shown in the last annual or consolidated accounts; or
|
●
|
in any other circumstances which do not require the publication by the issuer of a prospectus pursuant to Article 3 of the Prospectus Directive.
|
Page
|
||
F-1
|
||
F-2
|
||
F-3
|
||
F-4
|
||
F-5
|
||
F-6
|
||
F-7
|
||
F-8
|
Page
|
||
F-1
|
||
F-2
|
||
F-3
|
||
F-4
|
||
F-5
|
||
F-6
|
||
F-7
|
||
F-8
|
(Unaudited)
For The
Three Months
Ended
March 31,
2014
|
(Unaudited)
For The
Three Months
Ended
March 31,
2013
|
For the
Year Ended
December 31,
2013
|
For the
Year Ended
December 31,
2012
|
|||||||||||||
Revenues
|
$
|
-
|
$
|
31,558
|
32,768
|
62,806
|
||||||||||
Cost of Goods Sold
|
17,739
|
15,360
|
109,299
|
64,385
|
||||||||||||
Gross Income(Loss)
|
(17,739
|
)
|
16,198
|
(76,531
|
)
|
(1,579
|
)
|
|||||||||
Operating Expenses
|
||||||||||||||||
General and Administrative Expenses
|
326,428
|
175,016
|
1,233,683
|
1,036,005
|
||||||||||||
Depreciation and Amortization
|
6,794
|
8,600
|
38,297
|
56,600
|
||||||||||||
Consulting Expenses
|
61,145
|
13,048
|
390,437
|
829,845
|
||||||||||||
Total Operating Expense
|
394,367
|
196,664
|
1,662,417
|
1,922,450
|
||||||||||||
(LOSS) FROM OPERATIONS
|
(412,106
|
)
|
(180,466
|
)
|
(1,738,948
|
)
|
(1,924,029
|
) | ||||||||
Other Income (Expense)
|
||||||||||||||||
Interest (expense)
|
(13,999
|
)
|
(159,922
|
)
|
(652,703
|
)
|
(704,911
|
)
|
||||||||
Gain (loss) on Currency Transactions
|
-
|
(100,327
|
)
|
19,541
|
32,841
|
|||||||||||
Gain on forgiveness of debt
|
- |
|
-
|
49,016
|
-
|
|||||||||||
Gain on Derivative Liability
|
-
|
41,643
|
175,732
|
153,430
|
||||||||||||
Gain on Sale of Assets
|
-
|
-
|
1
|
15,020
|
||||||||||||
Interest Income
|
51
|
-
|
-
|
-
|
||||||||||||
Total Other Income (Expense)
|
(13,948
|
)
|
(218,606
|
)
|
(408,413
|
)
|
(503,620
|
)
|
||||||||
(Loss) Before Income Taxes
|
(426,054
|
)
|
(399,072
|
)
|
(2,147,361
|
)
|
(2,427,649
|
)
|
||||||||
Income Tax Expense (Benefit)
|
-
|
-
|
-
|
-
|
||||||||||||
NET (LOSS)
|
$
|
(426,054
|
)
|
$
|
(399,072
|
)
|
(2,147,361
|
)
|
2,427,649
|
)
|
||||||
BASIC AND DILUTED LOSS PER SHARE
|
$
|
(0.06
|
)
|
(0.08
|
)
|
(0.40
|
)
|
(0.46
|
)
|
|||||||
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING - BASIC AND DILUTED
|
7,065,333
|
5,318,151
|
5,332,721
|
5,318,151
|
(Unaudited)
|
||||||||||||||||
|
For the Three Months
|
For the Years Ended
December 31
|
||||||||||||||
|
Ended March 31
|
|||||||||||||||
|
2014
|
2013
|
2013
|
2012
|
||||||||||||
|
||||||||||||||||
Net Loss
|
(426,054 | ) | (399,072 | ) | $ | (2,147,361 | ) | $ | (2,427,649 | ) | ||||||
Currency Translation, Net of Taxes
|
(3,354 | ) | (139,052 | ) | (219,470 | ) | 85,702 | |||||||||
|
||||||||||||||||
Other Comprehensive Loss
|
$ | (429,408 | ) | $ | (538,124 | ) | $ | ( 2,366,831 | ) | $ | ( 2,341,947 | ) |
Other
|
||||||||||||||||||||||||||||
Additional
|
Compre-
|
|||||||||||||||||||||||||||
Preferred Stock
|
Common Stock
|
Paid-in
|
Accumulated
|
hensive
|
||||||||||||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
Capital
|
Deficit
|
Income
|
||||||||||||||||||||||
BALANCE, December 31, 2011
|
-
|
-
|
5,318,151
|
$
|
532
|
$
|
12,817,122
|
$
|
(14,946,116
|
)
|
273,981
|
|||||||||||||||||
Equity Adjustment for Foreign Currency Translation
|
-
|
-
|
-
|
-
|
-
|
-
|
(85,701
|
)
|
||||||||||||||||||||
Net Loss for the Year Ended December 31, 2012
|
-
|
-
|
-
|
-
|
-
|
(2,427,649
|
)
|
|||||||||||||||||||||
BALANCE, December 31, 2012
|
-
|
$
|
-
|
5,318,151
|
$
|
532
|
$
|
12,817,122
|
$
|
(17,373,765
|
)
|
$
|
188,280
|
|||||||||||||||
Common shares issued upon conversion of bond payable - related party and derivative liability at $9.00 per shares, December 2013
|
-
|
-
|
261,665
|
26
|
2,353,322
|
-
|
-
|
|||||||||||||||||||||
Common shares issued in payment of notes payable - related party at $6.42 per shares, December 2013
|
-
|
-
|
144,321
|
14
|
926,372
|
-
|
-
|
|||||||||||||||||||||
Common shares issued in payment of notes payable - related party at $6.42 per shares, December 2013
|
-
|
-
|
275,863
|
28
|
1,770,730
|
-
|
-
|
|||||||||||||||||||||
Equity Adjustment for Foreign Currency Translation
|
-
|
-
|
-
|
-
|
-
|
-
|
(219,470
|
)
|
||||||||||||||||||||
Net Loss for the Year Ended December 31, 2013
|
-
|
-
|
-
|
-
|
-
|
(2,147,361
|
)
|
-
|
||||||||||||||||||||
BALANCE, December 31, 2013
|
-
|
-
|
6,000,000
|
$
|
600
|
$
|
17,867,546
|
$
|
(19,521,126
|
)
|
$
|
(31,190
|
)
|
|||||||||||||||
To record the recapitalization of Subsidiary in connection with the February 12, 2014 Share Exchange Agreement wherein the DanDrit Biotech USA Inc. (“Parent”) issued 6,000,000 common shares to acquire a 100% interest in DanDrit Biotech A/S (“Subsidiary”) DanDrit Biotech USA Inc., (Formerly Putnam Hills Corp),
|
-
|
-
|
2,040,000
|
204
|
(79,436
|
)
|
-
|
-
|
||||||||||||||||||||
Equity Adjustment for Foreign Currency Translation
|
-
|
-
|
-
|
-
|
-
|
-
|
3,354
|
|||||||||||||||||||||
Net Loss for the Three Months Ended March 31, 2014
|
-
|
-
|
-
|
-
|
-
|
(426,054
|
)
|
-
|
||||||||||||||||||||
BALANCE, March 31, 2014
|
-
|
-
|
8,040,000
|
$
|
804
|
$
|
17,788,110
|
$
|
(19,947,180
|
)
|
$
|
(27,836
|
)
|
●
|
Level 1. Observable inputs such as quoted prices in active markets for identical assets or liabilities;
|
●
|
Level 2. Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly; and
|
●
|
Level 3. Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions.
|
Useful Life
|
March 31,
2014
|
December 31,
2013
|
December 31,
2012
|
|||||||||||||
Lab equipment and instruments
|
4-6 | $ | 202,632 | $ | 194,143 | $ | 194,143 | |||||||||
Computer equipment
|
4-6 | 110,898 | 66,493 | 66,493 | ||||||||||||
313,530 | 260,636 | 260,636 | ||||||||||||||
Less Accumulated Depreciation
|
(273,070 | ) | (260,636 | ) | (257,930 | ) | ||||||||||
Net Property and Equipment
|
$ | 40,460 | $ | - | 2,706 |
Year ending December 31,
|
||||
2014
|
$
|
17,283
|
||
2015
|
20,106
|
|||
2016
|
20,106
|
|||
2017
|
20,106
|
|||
2018
|
20,106
|
|||
Thereafter
|
136,059
|
|||
$
|
233,766
|
March 31,
2014 |
December 31,
2013 |
December 31,
2012 |
||||||||||
5% Note Payable Paseco ApS
|
$ | 888,880 | $ | - | - | |||||||
6% Note Payable DKTI A/S
|
- | - | 795,785 | |||||||||
6% Note Payable - Sune Olsen Holding ApS
|
- | - | 85,731 | |||||||||
Non-Interest Bearing Loan Payable Sunrise Financial Group Inc.
|
38,235 | - | - | |||||||||
Note Payable ML Group
|
21,520 | 21,557 | 20,618 | |||||||||
6% Promissory Note payable to NLBDIT 2010 Enterprises, LLC
|
41,945 | - | - | |||||||||
5% Note Payable - Sune Olsen Holding ApS
|
526,689 | 521,390 | - | |||||||||
5% Note Payable - Sune Olsen
|
187,932 | 185,054 | - | |||||||||
Total Notes Payable – Related Party
|
1,705,201 | 728,001 | 902,134 | |||||||||
Less Current Maturities
|
(1,705,201 | ) | (728,001 | ) | (106,349 | ) | ||||||
Note Payables – Related Party Long Term
|
$ | - | $ | - | 795,785 |
Year ending December 31,
|
||||
2014
|
1,705,201
|
|||
2015
|
- | |||
2016
|
-
|
|||
2017
|
-
|
|||
2018
|
-
|
|||
Thereafter
|
-
|
|||
-
|
Liability Derivatives
|
||||||||||
December 31, 2013
|
December 31, 2012
|
|||||||||
Balance Sheet
Location
|
|
Fair
Value
|
Balance Sheet
Location
|
|
Fair
Value
|
|||||
Derivatives not designated as hedging instruments
|
|
|
||||||||
Conversion feature on Convertible Bond
|
Derivative Liabilities
|
|
$
|
-
|
|
Derivative Liabilities
|
|
$
|
850,753
|
|
|
|
|||||||||
Total derivatives not designated as hedging instruments
|
|
$
|
-
|
|
|
$
|
850,753
|
|
December 31, 2013
|
December 31, 2012
|
|||||||||||||||||||||||||||||||
Fair Value Measurements Using:
|
Level 1
|
Level 2
|
Level 3
|
Total
|
Level 1
|
Level 2
|
Level 3
|
Total
|
||||||||||||||||||||||||
Liabilities
|
|
|
|
|
|
|||||||||||||||||||||||||||
Derivative Liabilities
|
- | - | - | - | - | - | $ | 850,753 | $ | 850,753 |
March 31,
2014
|
December 31,
2013
|
December 31,
2012
|
||||||||||
Excess of Tax over book depreciation Fixed assets
|
$ | 87,578 | $ | 87,578 | $ | 108,980 | ||||||
Excess of Tax over book depreciation Patents
|
114,028 | 114,028 | 8,076 | |||||||||
Net Operating Loss Carry forward
|
2,254,812 | 1,642,598 | 1,213,617 | |||||||||
Valuation Allowance
|
(2,456,418 | ) | (1,844,204 | ) | (1330,673 | ) | ||||||
Total Deferred Tax Asset (Liabilities)
|
$ | - | $ | - | - |
March 31,
2014
|
March 31,
2013
|
December 31,
2013
|
December 31,
2012
|
|||||||||||||
Computed Tax at Expected Statutory Rate
|
$ | (144,858 | ) | $ | (135,684 | ) | $ | (752,882 | ) | $ | (825,401 | ) | ||||
Non-US Income Taxed at Different Rates
|
44,858 | 38,059 | 199,292 | 218,488 | ||||||||||||
Non-Deductible expenses
|
- | 27,850 | 283,381 | 96,328 | ||||||||||||
Valuation allowance
|
100,000 | 69,775 | 270,209 | 510,585 | ||||||||||||
Income Tax Expense
|
$ | - | $ | - | - | - |
Current Tax Expense
|
March 31,
2014
|
March 31,
2012
|
December 31,
2013
|
December 31,
2012
|
||||||||||||
Danish Income Tax
|
$ | - | $ | - | $ | - | $ | - | ||||||||
Total Current Tax Expense
|
- | - | - | - | ||||||||||||
Deferred Income Tax Expense (Benefit)
|
||||||||||||||||
Excess of Tax over Book Depreciation Fixed Assets
|
- | - | 26,364 | 10,710 | ||||||||||||
Excess of Tax over Book Depreciation Patents
|
- | - | (105,585 | ) | (53,961 | ) | ||||||||||
Net Operating Loss Carry forwards
|
(100,000 | ) | (69,775 | ) | (2,319,956 | ) | (1,993,700 | ) | ||||||||
Change in the Valuation allowance
|
100,0000 | 69,775 | 2,399,177 | 2,036,951 | ||||||||||||
Total Deferred Tax Expense
|
$ | - | $ | - | $ | - | $ | - |
For the Three Months
Ended March 31,
|
For the Years
Ended December 31,
|
|||||||||||||||
2014
|
2013
|
2013
|
2012
|
|||||||||||||
Net (Loss)
|
(426,054 | ) | (399,072 | ) | (2,147,361 | ) | (2,427,649 | ) | ||||||||
Weighted average number of shares of common stock used in basic earnings per share
|
7,065,333 | 5,318,151 | 5,332,721 | 5,318,151 | ||||||||||||
Effect of dilutive securities, stock options and warrants
|
- | - | - | - | ||||||||||||
Weighted average number of shares of common stock and potential dilutive common shares outstanding used in dilutive earnings per share
|
7,065,333 | 5,318,151 | 5,332,721 | 5,318,151 |
Page
|
|
1
|
|
7
|
|
9
|
|
23
|
|
24
|
|
26
|
|
27
|
|
28
|
|
29
|
|
36
|
|
62
|
|
64
|
|
66
|
|
68
|
|
70
|
|
71
|
|
72
|
|
73
|
|
74
|
|
76 | |
77
|
|
80
|
|
80
|
|
80
|
|
80
|
Name
|
Securities
Beneficially
Owned Prior
to
Offering (1)
|
Securities Being
Offered
|
Securities
Beneficially
Owned After
Offering (2)
|
% Beneficial
Ownership
After
Offering
|
|||||||
Troutman Sanders LLP (3)
|
40,000
|
40,000
|
0
|
0
|
%
|
||||||
Total:
|
40,000
|
40,000
|
0
|
0
|
%
|
(1)
|
The Security Holder listed in the table below acquired the securities being offered in connection with the Share Exchange. Percentages stated in the above table are based on a total of 8,040,000 shares of Common Stock outstanding as of March 31, 2014,
including 185,053 shares of common stock reserved for issuance to the non-consenting shareholders of DanDrit Denmark and deemed issued and outstanding for accounting purposes
.
|
(2)
|
Assumes that all of the shares offered hereby are resold and that shares owned before the offering but not offered hereby are not sold.
|
(3)
|
The address of this security holder is 405 Lexington Ave., New York, NY 10174. Troutman Sanders LLP is counsel to the Placement Agents in the Offering.
|
(i)
|
as a bona fide gift or gifts;
|
(ii)
|
to any trust for the direct or indirect benefit of the undersigned or the immediate family of the transferring party;
|
(iii)
|
to the transferring party and/or any member of the immediate family of the transferring party from or by a grantor retained (or like-kind) annuity trust which exists as of the date hereof and was established for the direct or indirect benefit of the transferring party and/or any member of the immediate family of the transferring party pursuant to the terms of such trust
|
(iv)
|
if the transferring party is a corporation, partnership or other business entity (A) to another corporation, partnership or other business entity that is an affiliate (as defined under Rule 12b-2 of the Exchange Act) of the transferring party or (B) any distribution or dividend to equity holders of the transferring party as part of a distribution or dividend by the transferring party (including upon the liquidation and dissolution of the transferring party pursuant to a plan of liquidation approved by the transferring party 's equity holders), or if the transferring party is a trust, to a grantor or beneficiary of the trust;
|
(v)
|
in the event of a default under a pledge which exists as of the date hereof as security for a margin or loan account pursuant to the terms of such account;
|
(vi)
|
pursuant to any 10b5-l trading plans in effect as of the date of the Offering; or
|
(vii)
|
with the prior written consent of Sunrise Securities Corp., one of the Placement Agents.
|
|
●
|
ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers;
|
|
●
|
block trades in which the broker-dealer will attempt to sell the shares as agent but may position and resell a portion of the block as principal to facilitate the transaction;
|
|
●
|
purchases by a broker-dealer as principal and resale by the broker-dealer for its account;
|
|
●
|
an exchange distribution in accordance with the rules of the applicable exchange;
|
|
●
|
privately negotiated transactions;
|
|
●
|
settlement of short sales entered into after the effective date of the registration statement of which this prospectus is a part;
|
|
●
|
broker-dealers may agree with the selling security holder to sell a specified number of such shares at a stipulated price per share;
|
|
●
|
through the writing or settlement of options or other hedging transactions, whether through an options exchange or otherwise;
|
|
●
|
a combination of any such methods of sale; or
|
|
●
|
any other method permitted pursuant to applicable law.
|
Item 13. Other Expenses of Issuance and Distribution |
Amount
to be Paid
|
||||
SEC registration fee
|
$
|
1,571.36
|
||
FINRA filing fee
|
3,600.09
|
|||
Legal fees and expenses
|
175,000
|
|||
Accounting fees and expenses
|
60,000
|
|||
Printing and miscellaneous expenses
|
14,364.55
|
|||
Total
|
$
|
254,536
|
Item 14. Indemnification of Directors and Officers |
●
|
any breach of the director’s duty of loyalty to the corporation or its stockholders;
|
●
|
acts or omissions not in good faith or which involve intentional misconduct or a knowing violation of law;
|
●
|
payments of unlawful dividends or unlawful stock repurchases or redemptions; or
|
●
|
any transaction from which the director derived an improper personal benefit.
|
Item 15. Recent Sales of Unregistered Securities |
Item 16. Exhibit s |
DANDRIT BIOTECH USA, INC. | ||||
By:
|
/s/
Dr. Eric Leire
|
By:
|
/s/
Robert E. Wolfe
|
|
Dr. Eric Leire
|
Robert E. Wolfe
|
|||
Chief Executive Officer and President
|
Chief Financial Officer, Treasurer and Secretary
|
|||
(Principal Executive Officer)
|
(Principal Financial and Accounting Officer)
|
Signature
|
|
Title
|
|
Date
|
|
|
|
|
|
/s/ Dr. Eric Leire |
|
Chief Executive Officer and Director
|
|
July 3, 2014
|
Dr. Eric Leire
|
(Principal Executive Officer)
|
|
|
|
|
|
|||
/s/ Robert E. Wolfe |
|
Chief Financial Officer, Treasurer, Secretary and Director
|
|
July 3, 2014
|
Robert E. Wolfe
|
|
(Principal Accounting Officer)
|
|
|
|
|
|
||
/s/ NE Nielsen * |
|
Chairman of the Board
|
|
July 3, 2014
|
NE Nielsen
|
|
|
|
|
/s/ Dr. Jacob Rosenberg* |
|
Director
|
|
July 3, 2014
|
Dr. Jacob Rosenberg
|
|
|
|
|
/s/ Aldo Michael Noes Petersen* |
|
Director
|
|
July 3, 2014
|
Aldo Michael Noes Petersen
|
|
|
|
Exhibit Index
|
Exhibit
No.
|
Description
|
|
1.1
|
Form of Placement Agent Agreement.
*
|
|
|
||
2.1
|
Agreement and Plan of Share Exchange dated February 12, 2014. (3)
|
|
2.2
|
Share Cancellation Agreement dated February 12, 2014. (3)
|
|
3.1
|
Certificate of Incorporation. (8)
|
|
3.2
|
Bylaws. (4)
|
|
3.3
|
Articles of Association of DanDrit Denmark, as amended, dated February 26, 2004. (3)
|
|
3.4
|
Certificate of Ownership and Merger, dated February 12, 2014. *
|
|
4.1
|
Form of Common Stock Certificate. (2)
|
|
4.2
|
Form of Lock-Up Agreement. (6)
|
|
5.1
|
Form of Opinion of Richardson and Patel, LLP. (1)
|
|
10.1
|
Intellectual Property Assignment by and between DanDrit Denmark and Alexei Kirkin dated June 5, 2002. (3)
|
|
10.2
|
Collaboration Agreement by and between DanDrit Denmark and National Cancer Centre of Singapore Pte Ltd dated November 11, 2008. (3)
|
|
10.3
|
Master Services Agreement by and between DanDrit Denmark and Aptiv Solutions (UK) Ltd dated October 11, 2011. (3)
|
|
10.4
|
Employment Agreement by and between DanDrit Denmark and Dr. Eric Leire dated February 5, 2012. (3)
|
|
10.5
|
Box Packing and Moving Agreement by and between DanDrit Denmark and Bryde & Sonner A/S dated May 23, 2012. (3)
|
|
10.6
|
Debt Instrument by and between DanDrit Denmark and Sune Olsen Holding ApS dated March 31, 2013. (3)
|
|
10.7
|
Lease Agreement by and between Symbion A/S and DanDrit Denmark dated July 8, 2013. (3)
|
|
10.8
|
Lease Agreement by and between Ordnung ApS and DanDrit Denmark. (3)
|
|
10.9
|
Debt Instrument by and between DanDrit Denmark and Sune Olsen Holding ApS dated January 17, 2014. (3)
|
|
10.10
|
Consultancy Agreement by and between DanDrit Denmark and Dina Rosenberg dated February 4, 2014. (6)
|
|
10.11
|
Consulting Agreement by and between DanDrit Denmark and Paseco ApS dated February 11, 2014. (6)
|
|
10.12
|
DanDrit Biotech USA, Inc. 2014 Equity Incentive Plan. (6)
|
|
10.13
|
Loan Agreement by and between DanDrit Denmark and Paseco ApS dated March 21, 2014. (6)
|
|
10.14
|
Lease Agreement by and between Paseco ApS and DanDrit Denmark dated March 27, 2014. (6)
|
10.15
|
Confidential Disclosure Agreement by and between Etablissement Francais Du Sang and DanDrit Biotech A/S, dated March 8, 2013. (2)
|
|
10.16
|
Loan Agreement by and between DanDrit Denmark and Paseco ApS dated April 29, 2014. (7)
|
|
10.17
|
Letter of Support of Paseco ApS related to committed 2M DKK in additional financing, dated May 2, 2014. (7)
|
|
10.18
|
Early Access Agreement by and between DanDrit Denmark and Impatients, N.V. dated December 20, 2013. (3)
|
|
10.19
|
CFO Service Agreement by and between DanDrit Denmark and Mr. Robert Wolfe dated February 10, 2014. (1)
|
|
14.1
|
Code of Ethics. (5)
|
|
16.1
|
Letter from Raich Ende Malter & Co. LLP, dated February 14, 2014, to the SEC. (3)
|
|
21.1
|
List of Subsidiaries. (3)
|
|
23.1
|
Consent of Gregory & Associates, LLC.*
|
|
23.2
|
Consent of Richardson & Patel LLP (included in Exhibit 5.1). (1)
|
|
24.1
|
Powers of Attorney of the Directors and Officers of the Registrant (included in signature pages). (3)
|
|
99.1
|
Form of Subscription Agreement.*
|
|
101.1INS
|
XBRL Instant Document(1)
|
|
101.1SCH
|
XBRL Taxonomy Extension Schema Document(1)
|
|
101.1CAL
|
XBRL Taxonomy Extension Calculation Linkbase Document(1)
|
|
101.1DEF
|
XBRL Taxonomy Extension Definition Linkbase Document(1)
|
|
101.1LAB
|
XBRL Taxonomy Extension Label Linkbase Document(1)
|
|
101.1PRE
|
XBRL Taxonomy Extension Presentation Linkbase Document(1)
|
*
|
Filed herewith.
|
(1)
|
Filed as an exhibit to the Company’s Form S-1/A filed with the SEC on June 23, 2014 and incorporated herein by reference.
|
(2)
|
Filed as an exhibit to the Company’s Form S-1/A filed with the SEC on May 16, 2014 and incorporated herein by reference.
|
(3)
|
Filed as an exhibit to the Company’s Form S-1 filed with the SEC on February 14, 2014 and incorporated herein by reference.
|
(4)
|
Filed as an exhibit to the Company’s Form 10 filed with the SEC on August 12, 2011 and incorporated herein by reference.
|
(5)
|
Filed as an exhibit to the Company’s Annual Report on Form 10-K filed with the SEC on July 17, 2012 and incorporated herein by reference.
|
(6)
|
Filed as an exhibit to the Company’s Form S-1/A filed with the SEC on March 31, 2014 and incorporated herein by reference.
|
(7)
|
Filed as an exhibit to the Company’s Form 10-Q for the quarter ended March 31, 2014 filed with the SEC on May 14, 2014 and incorporated herein by reference.
|
(8)
|
Filed as an exhibit to the Company’s Form 10 filed with the SEC on August 12, 2011 and incorporated herein by reference.
|
DANDRIT BIOTECH USA, INC.
|
By:
|
|||
Name:
|
|||
Title:
|
Address for Notice:
|
|
DanDrit Biotech USA, Inc.
|
|
c/o DanDrit Biotech A/S
Fruebjergvej 3 Box 62
2100 Copenhagen, Denmark
|
|
Attention: Chief Executive Officer
|
|
Facsimile: [____________]
|
|
With a copy to:
|
|
Richardson & Patel LLP
|
|
The Chrysler Building
|
|
405 Lexington Avenue
New York, NY 10174
|
|
Attention: David Feldman
Facsimile: (917) 591-6898
|
|
Accepted and agreed to as of the date first written above on behalf of itself and as Representative of the several Placement Agents named on
Schedule 1
hereto:
|
SUNRISE SECURITIES CORP.
|
|||
By:
|
|||
Name:
|
|||
Title:
|
Address for Notice:
|
|
Sunrise Securities Corp.
|
|
600 Lexington Avenue, 23rd Floor
|
|
New York, NY 10022
|
|
Facsimile:
|
|
With a copy to:
|
|
Troutman Sanders LLP
|
|
The Chrysler Building
|
|
405 Lexington Avenue
New York, NY 10174
|
|
Attention: Henry I. Rothman
Facsimile: (212) 704-6288
|
[Signatory]
|
|||
By:
|
|||
Name:
|
|||
Title:
|
DANDRIT BIOTECH USA, INC.
|
By:
|
|||
Name:
|
|||
Title:
|
Accepted and agreed to as of the date first written above, on behalf of itself and as Representative of the several Placement Agents:
|
SUNRISE SECURITIES CORP.
|
||
By:
|
|||
Name:
|
|||
Title:
|
DESIGNATION | NUMBER | ||
Common Stock | 1,000 |
Signed on February 12, 2014 | PUTNAM HILLS CORP. | ||
|
By:
|
/s/ Samir N. Masri | |
Name: | Samir N. Masri | ||
Title: | CEO, CFO, President, Secretary and Director |
SOLE DIRECTOR:
|
|
/s/ Samir N. Masri | |
Samir N. Masri |
If to the Company, to:
|
|
DanDrit Biotech USA, Inc.
c/o DanDrit Biotech A/S
Fruebjergvej 3 Box 62
2100 Copenhagen, Denmark
Facsimile: [__________]
|
|
with a copy to:
|
|
Richardson & Patel LLP
The Chrysler Building
405 Lexington Avenue
New York, NY 10174
Attention: David Feldman
Facsimile: (917) 591-6898
|
Number of Shares
|
|||
Purchase Price Per Share:
|
$
|
||
Aggregate Purchase Price:
|
$
|
Name of DTC Participant:
(broker-dealer at which the account or accounts to be credited with the Shares are maintained)
|
|
DTC Participant Number:
|
|
Account Name:
|
|
Account Number:
|
|
Person to contact to initiate DWAC at closing:
|
|
Name:
|
|
Tel:
|
|
Email:
|