Innovation Pharmaceuticals Inc. - Quarter Report: 2010 March (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
DC 20549
_______________________________
FORM
10 – Q
_______________________________
x QUARTERLY REPORT UNDER SECTION 13 OR
15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended March 31, 2010
OR
¨ TRANSITION REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES AND EXCHANGE ACT OF
1934
Commission File Number:
000-52321
Cellceutix
Corporation
(Exact
name of registrant as specified in its charter)
Nevada
|
13-4303398
|
|
(State
or Other Jurisdiction of
|
(I.R.S.
Employer
|
|
Incorporation
or Organization)
|
Identification
Number)
|
100
Cumming Center, Suite 151-B
Beverly,
MA 01915
(Address
of principal executive offices and zip code)
(978)-633-3623
(Registrant's
telephone number, including area code)
Indicate
by check mark whether the registrant (1) has filed all reports required to be
filed by Section 13 or 15(d) of the Exchange Act during the preceding 12 months
(or for such shorter period that the registrant was required to file such
reports), and (2) has been subject to such filing requirements for the past 90
days. Yes x
No ¨
Indicate
by a check mark whether the registrant has submitted electronically and posted
on its corporate website, if any, every Interactive Data File required to be
submitted and posted pursuant to Rule 405 of Regulation S-T (232.405 of this
chapter) during the preceding 12 months (or for such shorter period that the
registrant was required to submit and post such files). Yes¨ No ¨
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, or a non-accelerated filer. See definition of
“accelerated filer and large accelerated filer” in Rule 12b-2 of the Exchange
Act. (Check one):
Large
accelerated filer ¨
|
Accelerated
filer ¨
|
Non-accelerated
filer ¨
|
Smaller
reporting company x
|
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act).
Yes ¨ No x
The
number of shares outstanding of the Registrant's Common Stock as of May 14, 2010
was 91,861,000 shares.
CELLCEUTIX
CORPORATION
FORM
10-Q
INDEX
TABLE
OF CONTENTS
PART
I FINANCIAL INFORMATION
|
|||
Item
|
1
|
Financial
Statements
|
1
|
Balance
Sheets- March 31, 2010 (Unaudited) and June 30, 2009
(Audited)
|
2
|
||
Statements
of Operations (Unaudited) - For the Three and Nine Months Ended
March
|
3
|
||
31,
2010 and 2009, and for the cumulative period from June 20,
2007
|
|||
(Date
of Inception) to March 31, 2010
|
|||
Statements
of Changes in Stockholder’s Deficit (Unaudited) - For
the
|
4
|
||
cumulative
period from June 20, 2007 (Date of Inception) to March 31,
2010
|
|||
|
Statement
of Cash Flows (Unaudited) - For the Nine Months Ended March 31,
2010
and
2009, and for the cumulative period from June 20, 2007 (Date of
Inception) to March 31, 2010
|
5
|
|
Notes
to Financial Statements (Unaudited)
|
6
|
||
Item
|
2
|
Management
Discussion & Analysis of Financial Condition and Results of
Operations
|
11
|
Item
|
3
|
Quantitative
and Qualitative Disclosures About Market Risk
|
13
|
Item
|
4T
|
Financial
Controls & Procedures
|
13
|
PART
II OTHER INFORMATION
|
|||
Item
|
1
|
Legal
Proceedings
|
13
|
Item
|
2
|
Unregistered
Sales of Equity Securities Use of Proceeds
|
13
|
Item
|
3
|
Default
Upon Senior Securities
|
13
|
Item
|
4
|
Submission
of Matters to a Vote of Securities Holders
|
13
|
Item
|
5
|
Other
Information
|
13
|
Item
|
6
|
Exhibits
And Reports on Form 8K
|
14
|
Signatures
|
15
|
1
Part
1. Financial Information
Item
1. Financial Statements
Cellceutix
Corporation
(A
Development Stage Enterprise)
Balance
Sheets
March
31, 2010
|
June
30, 2009
|
|||||||||
(Unaudited)
|
(Audited)
|
|||||||||
Assets
|
||||||||||
Current
assets:
|
||||||||||
Cash
|
$
|
51,899
|
$
|
140,380
|
||||||
Prepaid
expenses
|
28,378
|
14,853
|
||||||||
Total
current assets
|
80,277
|
155,233
|
||||||||
Total
assets
|
$
|
80,277
|
$
|
155,233
|
||||||
Liabilities
and Stockholders' Deficit
|
||||||||||
Current
liabilities:
|
||||||||||
Accounts
payable, including related party payables of $1,016,673 and $327,179,
respectively
|
$
|
1,066,497
|
$
|
340,013
|
||||||
Accrued
expenses, including related party accruals of $38,394 and $17,100,
respectively
|
49,015
|
59,100
|
||||||||
Accrued
salaries and payroll taxes
|
1,874,898
|
1,116,869
|
||||||||
Note
payable to officer
|
625,310
|
32,310
|
||||||||
Convertible
debentures
|
459,474
|
400,000
|
||||||||
Total
current liabilities
|
4,075,194
|
1,948,292
|
||||||||
Total
liabilities
|
4,075,194
|
1,948,292
|
||||||||
Commitments
and contingencies
|
||||||||||
Stockholders'
deficit:
|
||||||||||
Preferred
stock; $.0001 par value; 10,000,000 shares
|
||||||||||
authorized;
0 shares issued and outstanding
|
-
|
-
|
||||||||
Common
stock; $.0001 par value; 300,000,000 shares
|
||||||||||
authorized;
91,864,500 and 91,836,000 shares issued and outstanding,
respectively
|
9,186
|
9,184
|
||||||||
Additional
paid in capital
|
532,784
|
202,890
|
||||||||
Deficit
accumulated during development stage
|
(4,536,887
|
)
|
(2,005,133
|
)
|
||||||
Total
stockholders' deficit
|
(3,994,917
|
)
|
(1,793,059
|
)
|
||||||
Total
liabilities and stockholders' deficit
|
$
|
80,277
|
$
|
155,233
|
||||||
The
accompanying notes are an integral part of these financial
statements.
2
Cellceutix
Corporation
(A
Development Stage Enterprise)
Statements
of Operations
(Unaudited)
Three
Months Ended
|
Nine
Months Ended
|
|||||||||||||||||||
March
31, 2010
|
March
31, 2009
|
March
31, 2010
|
March
31, 2009
|
June
20, 2007 (Date of Inception) Through March 31, 2010
|
||||||||||||||||
Revenues
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
—
|
||||||||||
Operating
Expenses
|
||||||||||||||||||||
General
and administrative
|
17,382
|
10,156
|
79,238
|
30,569
|
152,326
|
|||||||||||||||
Payroll
expenses
|
192,578
|
240,600
|
783,363
|
659,919
|
2,067,047
|
|||||||||||||||
Patent
expense
|
—
|
—
|
—
|
—
|
19,443
|
|||||||||||||||
Professional
fees
|
57,225
|
9,533
|
170,007
|
69,991
|
358,903
|
|||||||||||||||
Research
and development
|
514,337
|
381,587
|
1,457,924
|
381,587
|
1,848,511
|
|||||||||||||||
Total
operating expenses
|
781,522
|
641,876
|
2,490,532
|
1,142,066
|
4,446,230
|
|||||||||||||||
Loss
from operations
|
(781,522
|
)
|
(641,876
|
)
|
(2,490,532
|
)
|
(1,142,066
|
)
|
(4,446,230
|
)
|
||||||||||
Interest
expense-net
|
(18,343
|
)
|
(8,696)
|
(41,222
|
)
|
(25,494)
|
(81,578
|
)
|
||||||||||||
Net
loss before provision for income taxes
|
(799,865
|
)
|
(650,572
|
)
|
(2,531,754
|
)
|
(1,167,560
|
)
|
(4,527,808
|
)
|
||||||||||
Provision
for income taxes
|
—
|
—
|
—
|
—
|
—
|
|||||||||||||||
Net
loss
|
$
|
(799,865
|
)
|
$
|
(650,572
|
)
|
$
|
(2,531,754
|
)
|
$
|
(1,167,560
|
)
|
$
|
(4,527,808
|
)
|
|||||
Basic
and Diluted Loss
|
$
|
(0.01
|
)
|
$
|
(0.01
|
)
|
$
|
(0.03
|
)
|
$
|
(0.01
|
)
|
||||||||
Weighted
average number of common shares used in basic and diluted per share
calculations
|
91,863,100
|
91,791,000
|
91,854,026
|
91,858,153
|
||||||||||||||||
The
accompanying notes are an integral part of these financial
statements.
3
Cellceutix
Corporation
(A
Development Stage Enterprise)
Statement
of Changes in Stockholders' Deficit
For the
Cumulative
Period
June 20, 2007 (Date of Inception)
through
March 31, 2010
(Unaudited)
Common
Stock
|
Additional
Paid
|
Deficit
Accumulated
During
Development
|
||||||||||||||||||
Shares
|
Par
Value $0.0001
|
In
Capital
|
Stage
|
Total
|
||||||||||||||||
Shares
issued June 20, 2007 (Inception)
|
1,000,000
|
$
|
100
|
$
|
—
|
$
|
—
|
$
|
100
|
|||||||||||
Net
loss
|
—
|
—
|
—
|
(530
|
)
|
(530
|
)
|
|||||||||||||
Balance,
June 30, 2007
|
1,000,000
|
100
|
—
|
(530
|
)
|
(430
|
)
|
|||||||||||||
Share
exchange with Cellceutix Pharma, Inc. December 6, 2007
|
(1,000,000
|
)
|
(100
|
)
|
—
|
100
|
—
|
|||||||||||||
Share
exchange in reverse merger with Cellceutix Pharma, Inc. December 6,
2007
|
82,000,000
|
8,200
|
—
|
(8,200
|
)
|
—
|
||||||||||||||
Shares
exchanged in a reverse acquisition of Cellceutix Pharma, December 6,
2007
|
9,791,000
|
979
|
—
|
(979
|
)
|
—
|
||||||||||||||
Issuance
of stock options
|
—
|
-
|
43,533
|
-
|
43,533
|
|||||||||||||||
Forgiveness
of debt from a stockholder
|
—
|
—
|
50
|
—
|
50
|
|||||||||||||||
Capital
contribution from a stockholder
|
—
|
—
|
50
|
—
|
50
|
|||||||||||||||
Shares
issued for services, April 28, 2008 at $1.05
|
100,000
|
10
|
104,990
|
—
|
105,000
|
|||||||||||||||
Net
loss
|
—
|
—
|
—
|
(510,193
|
)
|
(510,193
|
)
|
|||||||||||||
Balance,
June 30, 2008
|
91,891,000
|
9,189
|
148,623
|
(519,802
|
)
|
(361,990
|
)
|
|||||||||||||
Cancellation
of shares issued for services, December 31, 2008
|
(100,000)
|
(10)
|
(104,990)
|
—
|
(105,000)
|
|||||||||||||||
Issuance
of stock options
|
—
|
—
|
142,162
|
—
|
142,162
|
|||||||||||||||
Shares
issued for services, June 11, 2009 at $0.38
|
20,000
|
2
|
7,598
|
—
|
7,600
|
|||||||||||||||
Shares
issued for services, June 30, 2009 at $0.38
|
25,000
|
3
|
9,497
|
—
|
9,500
|
|||||||||||||||
Net
loss for the year ended
June
30, 2009
|
—
|
—
|
—
|
(1,485,331
|
)
|
(1,485,331
|
)
|
|||||||||||||
Balance,
June 30, 2009
|
91,836,000
|
9,184
|
202,890
|
(2,005,133
|
)
|
(1,793,059
|
)
|
|||||||||||||
Shares
issued for services, July 6, 2009 at $0.43
|
25,000
|
2
|
10,748
|
—-
|
10,750
|
|||||||||||||||
Shares
issued for services, February 5, 2010 at $0.30
|
3,500
|
—
|
1,050
|
—
|
1,050
|
|||||||||||||||
Issuance
of stock options
|
—
|
—
|
318,096
|
—
|
318,096
|
|||||||||||||||
Net
loss for the nine months ended March 31, 2010
|
—
|
—
|
—
|
(2,531,754
|
)
|
(2,531,754
|
)
|
|||||||||||||
Balance,
March 31, 2010 (unaudited)
|
91,864,500
|
$
|
9,186
|
$
|
532,784
|
$
|
(4,536,887
|
)
|
$
|
(3,994,917
|
)
|
|||||||||
The
accompanying notes are an integral part of these financial
statements.
4
Cellceutix
Corporation
(A
Development Stage Enterprise)
Statements
of Cash Flows
(Unaudited)
For
the Nine Months Ended March 31, 2010
|
For
the Nine Months Ended March 31, 2009
|
For
the Cumulative Period June 20, 2007 (Date of Inception)
through
March
31, 2010
|
||||||||||
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
||||||||||||
Net
loss
|
$
|
(2,531,754
|
)
|
$
|
(1,167,560
|
)
|
$
|
(4,536,887
|
)
|
|||
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||||
Stock
based compensation
|
318,096
|
135,125
|
503,791
|
|||||||||
Issuance
of common stock for services
|
16,237
|
—
|
22,791
|
|||||||||
Cancellation
of stock for services
|
—
|
(17,500
|
)
|
(17,500
|
)
|
|||||||
Amortization
of prepaid expenses
|
—
|
—
|
17,500
|
|||||||||
Changes
in operating assets and liabilities:
|
||||||||||||
Prepaid
expenses
|
(17,962
|
)
|
2,715
|
(3,190
|
)
|
|||||||
Accounts
payable
|
726,484
|
304,205
|
1,056,547
|
|||||||||
Accrued
expenses
|
49,389
|
27,051
|
108,489
|
|||||||||
Accrued
salaries and payroll taxes
|
758,029
|
524,794
|
1,874,898
|
|||||||||
Net
cash used in operating activities
|
(681,481
|
)
|
(191,170
|
)
|
(973,561
|
)
|
||||||
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
||||||||||||
Capital
contribution from a stockholder
|
—
|
—
|
50
|
|||||||||
Loan
from officer
|
593,000
|
—
|
625,310
|
|||||||||
Sale
of common stock
|
—
|
—
|
100
|
|||||||||
Proceeds
from convertible debentures
|
—
|
—
|
400,000
|
|||||||||
Net
cash provided by financing activities
|
593,000
|
—
|
1,025,460
|
|||||||||
NET
(DECREASE) INCREASE IN CASH
|
(88,481
|
)
|
(191,170
|
)
|
51,899
|
|||||||
CASH,
BEGINNING OF PERIOD
|
140,380
|
351,860
|
—
|
|||||||||
CASH,
END OF PERIOD
|
$
|
51,899
|
$
|
160,690
|
$
|
51,899
|
||||||
SUPPLEMENTAL
DISCLOSURE OF NON-CASH FLOW FINANCING ACTIVITIES:
|
||||||||||||
Common
stock issued for acquisition
|
$
|
—
|
|
$ |
—
|
$
|
9,079
|
|||||
Forgiveness
of debt
|
$
|
—
|
|
$ |
—
|
$
|
50
|
|||||
Reclassification
of accrued interest to convertible debentrues
|
$
|
59,474
|
|
$ |
$
|
59,474
|
The
accompanying notes are an integral part of these financial
statements.
5
Cellceutix
Corporation
(A
Development Stage Enterprise)
Notes to
Financial Statements
March 31,
2010
(Unaudited)
1. Background
Information
EconoShare,
Inc. was incorporated on August 1, 2005 in the State of Nevada and was organized
for the purpose of developing a B2B (Business to Business) website for an Asset
Sharing market place and transaction system.
On
December 6, 2007, EconoShare, Inc. acquired Cellceutix Pharma, Inc., a privately
owned Delaware corporation (“Cellceutix Pharma”), pursuant to an Agreement and
Plan of Share Exchange (the “Exchange”), with Cellceutix
Pharma becoming a wholly-owned subsidiary of EconoShare,
Inc. Cellceutix Pharma, Inc. was incorporated under the laws of the
State of Delaware on June 20, 2007. Its assets consisted of rights
assigned to it for six early stage pharmaceutical compounds by three different
scientists. Upon consummation of the Exchange, EconoShare, Inc. adopted the
business plan of Cellceutix Pharma, Inc.
Pursuant
to the terms of the Exchange, EconoShare, Inc. acquired Cellceutix Pharma, Inc.
in exchange for an aggregate of 82,000,000 newly issued shares of EconoShare,
Inc.’s common stock, par value $0.0001 per share (the “Common Stock”), which
resulted at that time in an aggregate of 91,791,000 shares (the “Exchange of
Shares”) of EconoShare, Inc. Common Stock issued and outstanding. As a result of
the Exchange, Cellceutix Pharma, Inc. became a wholly-owned subsidiary of
EconoShare, Inc. The Exchange Shares were issued to the Cellceutix
Pharma, Inc. shareholders on a pro rata basis, on the basis of 82 shares of
Common Stock for each share of Cellceutix Pharma, Inc. common stock held by such
Cellceutix Pharma, Inc. shareholder at the time of the
Exchange.
The
former holders of Cellceutix Pharma Common Stock at the time of the exchange
owned approximately 89% of the outstanding shares of our Common Stock.
Accordingly, the Exchange represented a change in control. As of March 31, 2010,
there are 91,864,500 shares of Common Stock issued and
outstanding. For financial accounting purposes, the acquisition was a
reverse acquisition of EconoShare, Inc. by Cellceutix Pharma, Inc., under the
purchase method of accounting, and was accounted for as a recapitalization as of
June 20, 2007 with Cellceutix Pharma, Inc. as the accounting
acquirer.
On
January 14, 2008, a majority of the shareholders of EconoShare, Inc. approved an
amendment to the Registrant’s articles of incorporation to change the name of
the Registrant to Cellceutix Corporation (“the Company”). Upon the
filing of a Definitive Information Statement and effectiveness of the name
change the Company applied to the National Association of Security Dealers to
change its stock symbol on the Over the Counter Bulletin Board, resulting in the
Company’s new stock symbol of “CTIX”. The Company is considered a development
stage company at this time.
2. Financial
Statements
In the
opinion of management, all adjustments consisting only of normal recurring
adjustments necessary for a fair statement of (a) the results of operations for
the three and nine month periods ended March 31, 2010 and 2009, (b) the
financial position at March 31, 2010 and (c) cash flows for the nine month
periods ended March 31, 2010 and 2009, have been made.
The
unaudited financial statements and notes are presented as permitted by Form
10-Q. Accordingly, certain information and note disclosures normally included in
the financial statements prepared in accordance with accounting principles
generally accepted in the United States of America have been omitted. The
accompanying financial statements and notes should be read in conjunction with
the Company’s Form 10K for the fiscal year ended June 30, 2009. The
results of operations for the three and nine month period ended March 31, 2010
are not necessarily indicative of those to be expected for the entire year.
3. Going
Concern
The
accompanying financial statements have been prepared assuming the Company will
continue as a going concern. For the period since June 20, 2007 (date of
inception) through March 31, 2010, the Company has had a cumulative net loss of
$4,527,808, no revenue and a negative working capital of $3,994,917 at March 31,
2010. As of March 31, 2010, the Company has not emerged from the
development stage. In view of these matters, the ability of the Company to
continue as a going concern is dependent upon the Company’s ability
to generate
additional financing. Since inception, the Company has financed its activities
principally from the use of equity securities as well as debt financing from
related parties and other sources to pay for services. The Company intends on
financing its future development activities and its working capital needs
largely from the sale of equity securities, until such time that funds provided
by operations are sufficient to fund working capital requirements. There can be
no assurance that the Company will be successful at achieving its financing
goals at reasonably commercial terms, if at all.
6
The
recent economic downturn and market instability has made the business climate
more volatile and more costly. If the current equity and credit
markets deteriorate further or do not improve, it may make necessary debt or
equity financing more difficult, more costly and more
dilutive. Failure to secure any necessary financing in a timely
manner and on favorable terms could have a material adverse effect on the
Company’s growth strategy, financial performance and stock price and could
require the delay of new product development and clinical trial
plans. Currently, the Company has not made any arrangements for
equity or any other type of financing.
These
factors raise substantial doubt about the Company's ability to continue as a
going concern. The accompanying financial statements do not include any
adjustments relating to the recoverability of the recorded assets or the
classification of liabilities that may be necessary should the Company be unable
to continue as a going concern.
4. Recent accounting
pronouncements
In
October 2009, the Financial Accounting Standards Board (“FASB”) issued new
guidance for revenue recognition with multiple deliverables. This new
guidance impacts the determination of when the individual deliverables, included
in a multiple-element arrangement may be treated as separate units of
accounting. Additionally, it modifies the manner in which the
transaction consideration is allocated across the separately identified
deliverables by no longer permitting the residual method of allocating
arrangement consideration. This new guidance is effective for revenue
arrangements entered into or materially modified in fiscal years beginning on or
after June 15, 2010, however early adoption is permitted. The Company
does not expect this new guidance to have a material effect on the financial
statements.
In
January 2010, the FASB issued new guidance which improves disclosures about fair
value measurements. The new standard is effective for interim and
annual periods beginning after December 15, 2009, except for certain disclosures
regarding Level 3 measurements, which are effective for fiscal years beginning
after December 15, 2010. The Company is evaluating the impact of this
guidance on its financial statements and does not expect this new guidance to
have a material effect on the financial statements.
In
February 2010, the FASB issued updated guidance to address certain
implementation issues related to an entity’s requirements to perform and
disclose subsequent events. This update requires SEC filers to
evaluate subsequent events through the date the financial statements were issued
and exempts SEC filers from disclosing the date through which subsequent events
have been evaluated. The updated guidance was effective upon
issuance, and did not have a material impact on the Company’s financial
statements.
Other
recent accounting pronouncements issued by FASB (including EITF), the AICPA and
the SEC did not or are not believed by management to have a material impact on
the Company’s present or future financial statements.
5. Commitments
and Contingencies
On April
1, 2009, the Company entered into an agreement, subsequently amended, with
a Consultant to assist the Company's Chief Scientific Officer to organize,
manage and display data from animal studies as well as information relating to
Active Pharmaceutical Ingredients and formulations of the Company's products
through February 28, 2010. The Consultant was compensated at the rate of $4,000
per month payable on the last day of each month. In addition, at the end of each
month of services provided, the Consultant is granted options to purchase 10,000
shares of Company's common stock. As of March 31, 2010, the
Consultant has been awarded a total of 120,000 options to purchase common stock
valued at $33,414 to be vested over one year. For the three and nine
months ended March 31, 2010, the Company has expensed $6,964 and $15,711 to
professional fees expense, related to these options.
On July
6, 2009, the Company entered into a one year agreement with a Consultant to
serve as a scientific advisor and to participate as a member of the Company’s
Scientific Advisory Board. In exchange for these services, the
Company has granted the Consultant 25,000 shares of common stock valued at
$10,750. At March 31, 2010, the Company has included $2,688 as a
prepaid expense to be amortized over the Consultant’s remaining service
period.
7
In June
2009, the Company signed an agreement with Girindus America, Inc., for the cGMP
manufacture of Kevetrin active pharmaceutical ingredient. As of March
31, 2010, the remaining balance of Girindis work to be performed per the
agreement is approximately $24,500.
On
October 22, 2009, the Company signed an agreement with Toxikon Corporation to
conduct preclinical studies required for an Investigational New Drug (IND)
filing for its cancer drug Kevetrin(TM) for total payments of approximately
$576,000. The studies covered by the agreement are designed to confirm that
Kevetrin meets FDA safety requirements for studies in humans. For
the nine months ended March 31, 2010, the Company has paid $180,928 and expensed
approximately $219,200.
On
January 1, 2010, the Company entered into a one year agreement with an
individual for consulting services. In exchange for these services,
the Company granted the Consultant 50,000 options to purchase common
stock. The options were valued using the Black-Scholes option model
for $14,186. As of March 31, 2010, the Company recorded $10,639 in
prepaid expenses related to this agreement and expensed $3,547.
On
February 5, 2010 the Company entered into an agreement with a medical
dermatologist for consulting services. In exchange for these
services, the Company granted the Consultant 3,500 shares of common stock valued
at $1,050.
On March
13, 2010, the Company signed a manufacturing agreement with Formatech Inc. for
the aseptic filling of Kevetrin. Aseptic filled vials of Kevetrin are required
by the FDA for use in human clinical studies. As of March 31, 2010,
the remaining balance of Formatech work to be performed per the agreement is
approximately $128,000.
Pharmaceutical
Compounds
On August
2, 2007, the Company was assigned all right, title, and interest to three
pharmaceutical compounds; Kevetrin, KM 277 and KM 278, by their inventors. The
Company was assigned all right, title, and interest to an additional three
pharmaceutical compounds on October 17, 2007, KM 133 KM 362 and KM 3174. In July
2009, the Company was assigned all right, title, and interest to KM
732. In exchange for these compounds, the Company agreed to pay the
inventors 5% of net sales of the compounds in countries where composition of
matter patents have been issued and 3% of net sales in other countries.
Kevetrin, KM 277, KM 278 and KM 362 were acquired from our President and
director, Dr. Krishna Menon. The Company filed a patent application
for Kevetrin and intends to file patent applications for each of the other six
compounds as funds become available.
In
December, 2009 the Company was assigned all right, title and interest to a new
compound, KM-391, which it intends to develop for the treatment of
autism. In exchange for this compound, the Company agreed to pay the
inventors $10,000.00 plus 4.5% of net sales the compound in countries where a
composition of matter patent has been issued and 3% of net sales in other
countries.
Employment
Agreements
On
December 7, 2007, the Company entered into employment agreements with its two
executive officers, George Evans, Chief Executive Officer, and Krishna Menon,
Chief Scientific Officer. Both agreements provide for a three year term with
minimum annual base salaries of $200,000 in the first year, $300,000 in the
second year and $400,000 in the third year. In addition, the
agreements provide for bonuses according to the following schedule:
Upon
receiving IND: $250,000 if received within 10 months
$150,000
if received within 12 months
$100,000
if received within 16 months
Completion
of Phase 1with clinical results that would have Kevetrin proceed to Phase
2/3:
$450,000
if received within 18 months
$350,000
if received within 24 months
$150,000
if received within 28 months
Start
Phase 2/3:
$500,000
if within 36 months
8
$350,000
if within 42 months
$150,000
if within 48 months
The bonus
obligations do not commence until the Company receives a financing commitment in
an amount of at least $4,000,000.
The
agreement with Mr. Evans also provides a grant of options to purchase 918,610,
918,910 and 917,910 shares of the Company's stock with exercise prices of $0.35,
$0.20 and $0.15 per share and fair values of $257,834, $123,282 and $43,533 for
the nine months ended March 31, 2010 and the years ended June 30, 2009 and 2008,
respectively. The agreement calls for the issuance options to
purchase up to 1% of the common shares outstanding at each subsequent
anniversary year.
As of
March 31, 2010, the Company has recorded accrued officer’s salaries and payroll
taxes are as follows:
George
Evans
|
$
|
633,333
|
||
Krisna
Menon
|
633,333
|
|||
Leo
Ehrich
|
475,000
|
|||
Accrued
Payroll Taxes
|
133,232
|
|||
$
|
1,874,898
|
6. Related
Party Transactions
Office
Lease
Dr.
Menon, the Company’s principal shareholder, President, and Director, also serves
as the Chief Operating Officer and Director of Kard Scientific (“KARD”). On
December 7, 2007, the Company began renting office space from KARD, on a month
to month basis for $900 per month. At March 31, 2010 and June 30,
2009, payables of $25,200 and $19,800 to KARD were included in accrued expenses,
respectively. For the three and nine months ended March 31, 2010 and 2009, the
Company has included $2,700, $8,100, $2,700, and $8,100 in general and
administrative expenses, respectively.
Clinical
Studies
As of
September 28, 2007 the Company engaged KARD to conduct specified pre-clinical
studies necessary for the Company to prepare an IND submission to the
FDA. The Company does not have an exclusive arrangement with
KARD. All work performed by KARD must have prior approval by the
executive officers of the Company, and the Company retains all intellectual
property resulting from the services by KARD. For the three and nine months
ended March 31, 2010 and 2009, the Company incurred $253,341, $813,697,
$381,587 and $381,587 of research and development expenses by KARD,
respectively. At March 31, 2010, the Company has included a total of
$1,012,796 in accounts payable to Kard.
7. Due
To Officer
During
the nine months ended March 31, 2010, Mr. Ehrlich, an officer of the Company,
converted previous amounts provided in cash to the Company of $32,310 into a
loan (the “Ehrlich Promissory Note A”). The
Ehrlich Promissory Note A was an unsecured, 6% per
annum simple interest bearing, demand note. During the same period,
Mr. Ehrlich provided an additional $85,000 in cash in the form of a loan to the
Company (the “Ehrlich
Promissory Note B”). The
Ehrlich Promissory Note B was an unsecured, 6% per annum simple interest
bearing, demand note.
On
October 15 and 29, 2009 and during the three months ended March 31, 2010, Mr.
Ehrlich, loaned the Company an additional $508,000. A condition for this loan
was that the Ehrlich Promissory Note A and Ehrlich Promissory Note B be replaced
with a new note, Ehrlich
Promissory Note C. The Ehrlich Promissory Note C combines the
balances of Ehrlich Promissory Notes A and B, plus the additional loan amount of
$508,000 for a total principal balance of $625,310. The Ehrlich Promissory
Note C is an unsecured demand note that bears 9% simple interest per
annum. The note requires that the interest rate on the amounts due on
Ehrlich Promissory Notes A and B be changed retroactively, beginning October 1,
2009, to 9%. As of March 31, 2010, the Company has recorded interest
of $13,194 in accrued expenses.
9
On April
30, 2010, subsequent to the date of the Balance Sheet, Mr. Ehrlich, an officer
of the Company, loaned the Company an additional $80,000. This amount was added
to the balance of Ehrlich
Promissory Note C.
8. Stock
Options and Warrants:
The
Company granted 140,000 options to consultants and 918,610 to an officer during
the nine months ended March 31, 2010. The fair value of the options
was estimated on the date of grant using Black Scholes model that uses
assumptions noted in the following table. Expected volatility is
based on the average of the monthly trading of similar Company’s underlying
common stock (as the Company does not have an adequate trading history for an
accurate calculation) and other factors.
Nine
Months Ended
March
31, 2010
|
|||
Dividend
rate
|
0%
|
||
Risk
free interest rate
|
1.12% –
2.69%
|
||
Expected
term
|
3
years
|
||
Expected
volatility
|
105.7% –
119.70%
|
Stock
Options
The following
table summarizes all stock option activity under the Company’s stock option
plan:
Number
of Options
|
Weighted
Average Exercise Price
|
Weighted
Average Remaining Contractual Life (Years)
|
Aggregate
Intrinsic Value
|
||||||||||
Outstanding
at June 30, 2009
|
2,066,820
|
$
|
0.17
|
2.04
|
—
|
||||||||
Granted
|
1,058,610
|
0.40
|
2.69
|
—
|
|||||||||
Exercised
|
—
|
—
|
—
|
—
|
|||||||||
Forfeited/expired
|
—
|
—
|
—
|
—
|
|||||||||
Outstanding
at March 31, 2010 (unaudited)
|
3,125,430
|
$
|
0.25
|
1.76
|
$
|
713,084
|
|||||||
Exercisable
at March 31, 2010 (unaudited)
|
3,011,263
|
$
|
0.25
|
1.73
|
$
|
702,937
|
The
Company recognized $31,438 and $318,096 of compensation costs related to option
awards granted during the three and nine months ended March 31, 2010,
respectively, and there is $21,452 of unamortized compensation cost expected to
be recognized through March 31, 2011.
As of
March 31, 2010, there were 2,964,000 warrants issued and outstanding with an
exercise price of $0.81. The warrants expire in September
2010.
9. Convertible
Debentures
On May 7,
2008, the Company issued Convertible Debentures, at 9% per annum, for a total
amount of $400,000. The principle and related accrued interest were
due December 2009, and secured by the Company’s assets. The
Debentures and any accrued and unpaid interest were convertible into the
Company’s common stock, at the holder’s request, at a conversion price of
$1.50.
During
January, 2010, the Company extended and amended the original Convertible
Debenture agreements by increasing the principal balance by $166,667 and
extending the original maturity date to December 31, 2010. The conversion
price of the principal and any unpaid interest was changed to $0.50.
Subsequent to March 31, 2010, the Company entered into an agreement with the
lenders to eliminate the increase in principal balance and instead add to the
original principal amount accrued interest through December 31, 2009 in the
amount of $59,474.
9. Subsequent
Events
10
Item
2. Management's Discussion and Analysis of Financial Condition and Results of
Operations
The
following discussion of the Company's financial condition and the results of
operations should be read in conjunction with the Financial Statements and Notes
thereto appearing elsewhere in this document.
The
Private Securities Litigation Reform Act of 1995 provides a safe harbor for
forward-looking statements. In order to comply with the terms of the safe
harbor, the Company notes that in addition to the description of historical
facts contained herein, this report contains certain forward-looking statements
that involve risks and uncertainties as detailed herein and from time to time in
the Company's other filings with the Securities and Exchange Commission and
elsewhere. Such statements are based on management's current expectations and
are subject to a number of factors and uncertainties, which could cause actual
results to differ materially from those, described in the forward-looking
statements. These factors include, among others: (a) the Company's fluctuations
in sales and operating results; (b) risks associated with international
operations; (c) regulatory, competitive and contractual risks; (d) product
development risks; (e) the ability to achieve strategic initiatives, including
but not limited to the ability to achieve sales growth across the business
segments through a combination of enhanced sales force, new products, and
customer service; and (f) pending litigation.
Management’s
Plan of Operation
We are an
early stage developmental biopharmaceutical company. We have no product
sales to date and we will not receive any product revenue until we receive
approval from the FDA or equivalent foreign regulatory bodies to begin selling
our pharmaceutical candidates. Developing pharmaceutical products, however, is a
lengthy and very expensive process. Assuming we do not encounter any unforeseen
safety issues during the course of developing our product candidates, we do not
expect to complete the development of a product candidate for several years, if
ever.
In August
and October 2007, we acquired exclusive rights to a total of six (6)
pharmaceutical compound candidates that are designed for treatment of diseases
which may be either existing or diseases identified in the future. In
July, 2009 we acquired the rights to an additional compound, and in December
2009 we acquired the rights to an eighth compound. The Company will
initially spend most of its efforts and resources on its anti-cancer compound,
Kevetrin, for the treatment of certain cancers. Kevetrin is
furthest along in in-vivo studies in small animals. Based on the
experimental studies results to date, the Company has decided to advance
Kevetrin along the regulatory and clinical pathway. We anticipate using our
expertise to manage and perform what we believe are the most critical aspects of
the product development process which include: (i) the design and oversight of
clinical trials; (ii) the development and execution of strategies for the
protection and maintenance of intellectual property rights; and (iii) the
interaction with regulatory authorities internationally. We expect to
concentrate on product development and engage in a limited way in product
discovery, avoiding the significant investment of time and financial resources
that is generally required before a compound is identified and brought into
clinical trials. In addition, we are currently engaged in pre-clinical testing
of one of our product candidates and intend to out-source clinical trials,
pre-clinical testing and have currently outsourced the cGMP manufacturing of
Kevetrin to third parties (Girindus America, Inc.).
We are
now engaged in organizational activities, sourcing compounds, synthesis of
experimental quantities, and the outsourcing of Kevetrin toxicology
studies. We have incurred $1,848,511 in research and
development expenses from inception through March 31, 2010. We have not
obtained sufficient funding for our drug development business plan, nor have we
generated any revenues, nor do we not expect to generate revenues in the near
future. We may not be successful in developing our drugs and start selling our
products when planned, or that we will become profitable in the future. We have
incurred net losses in each fiscal period since inception of our
operations.
With
reference to Kevetrin, in January, 2010, the Company had a “pre-IND” meeting
with the U. S. Food and Drug Administration (FDA). The purpose of the
meeting was to obtain comments from the FDA on the protocols for the toxicity
and pharmacology studies that are required for IND filing. The FDA
provided comments on the protocols, which were adopted by the
Company. The Company is in the process of completing these
studies.
Summaries and graphs
of the results of experiments with Kevetrin in animal models of drug resistant
lung cancer, breast cancer and colon cancer have been made available on
the Company’s website at www.cellceutix.com. A brief summary
of the results are as follows:
11
·
|
Lung
Cancer
|
|
Kevetrin
was studied in two cell lines of multi-drug resistant lung cancer.
In two studies with the A549 cell line, Kevetrin showed average tumor
growth delay of 72% and average tumor volume reduction of 81% compared to
controls. Both tumor growth delay and tumor volume reduction were
also significantly greater with Kevetrin than with paclitaxel (Taxol)
(p<0.001).
|
·
|
In
two studies with the NCI-H1975 cell line of multi-drug resistant lung
cancer, Kevetrin showed average tumor growth delay of 149% and tumor
volume reduction of 94% compared to controls. Both tumor growth
delay and tumor volume reduction were greater with Kevetrin than with
paclitaxel (p<0.001).
|
·
|
Breast
Cancer
|
|
In
animal model testing on a taxane-resistant, estrogen receptor-negative
breast cancer human cell line, MDA-MB-435s, tumor volume was reduced by
72% and tumor growth was delayed by more than 52% with Kevetrin when
compared with paclitaxel (Taxol) (p<0.01) or with cisplatin
(p<0.01).
|
·
|
Colon
Cancer
|
|
Kevetrin
showed tumor growth delay of 43% compared to controls and paclitaxel when
tested on animals with HCT-15 P-glycoprotein drug resistant colon
cancer.
|
KM-391-
compound in development for the treatment of autism
We
announced positive results in an animal study of its autism compound,
KM-391. In a
carefully conducted study, KM-391 was given orally over 90 days to groups of
rats at two dosage levels. At each dosage level, KM-391 demonstrated
significant improvements in the test animals when compared to both the “no
treatment” group and the “active control” (fluoxetine) group on the parameters
of brain plasticity, serotonin levels and behavioral function. These
parameters were selected as important indicators of the effect needed to
successfully treat autism.
Presently,
we are having additional quantities of KM-391
manufactured. Further experiments are planned once the compound
is received.
Liquidity
and Capital Resources
As of
March 31, 2010 the Company had a cash balance of $51,899. The
Company will need to raise substantial funds in order to execute its product
development plan. Based upon our expected rate of expenditures, we
currently do not have sufficient cash reserves to meet all of our anticipated
obligations through our fiscal year end of June 30, 2010. The Company may
seek to raise capital through an offering of our common stock or other
securities of the Company. However, there can be no assurance that we will be
successful in securing the capital we require or that we may obtain financing on
terms and conditions that are acceptable to the Company.
On May 7,
2008, the Company issued Convertible Debentures, at 9% per annum, for a total
amount of $400,000. The principle and related accrued interest were
due December 2009, and secured by the Company’s assets. The
Debentures and any accrued and unpaid interest were convertible into the
Company’s common stock, at the holder’s request, at a conversion price of
$1.50.
During
January, 2010, the Company extended and amended the original Convertible
Debenture agreements by increasing the principal balance by $166,667 and
extending the original maturity date to December 31, 2010. The conversion
price of the principal and any unpaid interest was changed to $0.50.
Subsequent to March 31, 2010, the Company entered into an agreement with the
lenders to eliminate the increase in principal balance and instead add to the
original principal amount accrued interest through December 31, 2009 in the
amount of $59,474.
During
the nine months ended March 31, 2010, Mr. Ehrlich, an officer of the Company,
converted previous amounts provided in cash to the Company of $32,310 into a
loan (the “Ehrlich Promissory Note A”). The
Ehrlich Promissory Note A was unsecured, 6% per annum simple interest bearing,
demand note. During the same period, Mr. Ehrlich provided an
additional $85,000 in cash in the form of a loan to the Company (the” Ehrlich Promissory Note
B”). The Ehrlich Promissory Note B was unsecured, 6% per annum
simple interest bearing, demand note.
12
On
October 15 and 29, 2009 and during the three months ended March 31, 2010, Mr.
Ehrlich, loaned the Company an additional $508,000. A condition for this loan
was that the Ehrlich Promissory Note A and Ehrlich Promissory Note B be replaced
with a new note, Ehrlich
Promissory Note C. The Ehrlich Promissory Note C combines the
balances of Ehrlich Promissory Notes A and B, plus the additional loan amount of
$508,000 for a total principal balance of $625,310. The Ehrlich Promissory
Note C is an unsecured demand note that bears 9% simple interest per
annum. The note requires that the interest rate on the amounts due on
Ehrlich Promissory Notes A and B be changed retroactively, beginning October 1,
2009, to 9%. As of March 31, 2010, the Company has recorded interest
of $13,194 in accrued expenses.
On April
30, 2010, subsequent to the date of the Balance Sheet, Mr. Ehrlich, an officer
of the Company, loaned the Company an additional $80,000. This amount was added
to the balance of Ehrlich
Promissory Note C.
Requirement
for Additional Capital
Research
and Development Costs. The Company has engaged in limited research and
development activities. We currently do not have sufficient funds to meet our
planned drug development for the next twelve (12) months and we may not be able
to obtain the necessary financing on terms and conditions acceptable to the
Company. Assuming that we are successful in raising additional financing, we
plan to incur the following expenses over the next twelve (12)
months:
Ø
|
Research
and Development of $3,250,000: Includes planned costs for Kevetrin of
$1,250,000 for additional in-vivo, in-vitro, pharmaco-kinetic,
pharmaco-dynamic, and toxicology studies; and cGMP materials, which should
result with the data required to file an investigational new drug
application (“IND”) with the FDA; and $2,000,000 in preclinical
development costs for our other compounds.
|
Ø
|
Clinical
trials – We have budgeted $2,000,000 for our Phase 1 trials (assumes
success of Company’s IND filing for Kevetrin)..
|
Ø
|
Corporate
overhead of $1,250,000: Budgeted office salaries, legal, accounting and
other costs expected to be incurred.
|
Ø
|
Capital
costs of $500,000: Estimated cost for equipment and laboratory
improvements.
|
Ø
|
Staffing
costs of $500,000: The Company expects to incur these costs for
the filing of the IND which include additional scientific staff and
consulting firms to assist with FDA compliance, material characterization,
pharmaco-kinetic, pharmaco-dynamic and toxicology
studies.
|
The
Company will be unable to proceed with its full planned drug development
program(s), meet its administrative expense requirements, capital costs, or
staffing costs without obtaining additional financing of approximately
$7,500,000 (as per current management’s budgets). The Company does not have any
arrangements at this time for equity or other financings towards meeting this
financing requirement. If we are unable to obtain additional financing on terms
and conditions acceptable to the Company, our business plan will be
significantly delayed.
In June
2009, the Company signed an agreement with Girindus America, Inc., for the cGMP
manufacture of Kevetrin active pharmaceutical ingredient. As of March
31, 2010, the remaining balance of Girindus work to be performed per the
agreement is approximately $24,500.
On
October 22, 2009, the Company signed an agreement with Toxikon Corporation to
conduct preclinical studies required for an Investigational New Drug (IND)
filing for its cancer drug Kevetrin(TM). The studies covered by the agreement
are designed to confirm that Kevetrin meets FDA safety requirements for studies
in humans. As of March 31, 2010, the remaining balance of Toxikon
work to be performed per the agreement is approximately $395,000.
On March
13, 2010, the Company signed a manufacturing agreement with Formatech Inc. for
the aseptic filling of Kevetrin. Aseptic filled vials of Kevetrin are
required by the FDA for use in human clinical studies. As of March 31,
2010, the remaining balance of Formatech work to be performed per the agreement
is approximately $128,000.
Subsequent
Events
During
May, 2010, the Company signed an agreement with Medical Research Consulting
Services for monitoring services for a planned phase 1 study of
Kevetrin.
13
Off-Balance
Sheet Arrangements.
The
Company does not have any off-balance sheet arrangements, as defined in Item
304(a)(4)(ii) of Regulation S-K under the Securities Exchange Act of 1934, as
amended.
Item
3. Quantitative and Qualitative Disclosures About Market
Risk
Not
applicable
Item
4T. Controls and Procedures
The
Company’s Chief Financial Officer and Chief Financial Officer has evaluated the
effectiveness of the Company’s disclosure controls and procedures (as defined in
Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of March 31, 2010,
covered by this Quarterly Report on Form 10-Q. Based upon such
evaluation, the Chief Executive Officer and Chief Financial Officer
has concluded that, as of the end of such period, the Company’s disclosure
controls and procedures were not effective as required under Rules 13a-15(e) and
15d-15(e) under the Exchange Act. This conclusion by the Company’s Chief
Executive Officer and Chief Financial Officer does not relate to reporting
periods after March 31, 2010.
Changes
in Internal Control over Financial Reporting
No change
in the Company’s internal control over financial reporting occurred during the
quarter ended March 31, 2010, that materially affected, or
is reasonably likely to materially affect, the Company’s internal control over
financial reporting.
PART
II. OTHER INFORMATION
Item
1. Legal Proceedings
None.
Item
2. Unregistered sales of equity securities
On
February 5, 2010 the Company entered into an agreement with a medical
dermatologist for consulting services. In exchange for these
services, the Company granted the Consultant 3,500 shares of common stock valued
at $1,050.
Item
3. Defaults Upon Senior Securities
None
Item
4. Submission Of Matters To A Vote Of Security Holders
None
Item
5. Other Information
None
14
Item
6. Exhibits
(a) Exhibit
index
Exhibit
|
|
|
31.1
|
|
Certification
of Chief Executive Officer required by Rule 13a-14(a) or Rule 15d-14(a)
under the Securities Exchange Act of 1934, as amended.
|
31.2
|
|
Certification
of Chief Financial Officer required by Rule 13a-14(a) or Rule 15d-14(a)
under the Securities Exchange Act of 1934, as amended.
|
32.1
|
|
Certification
of Chief Executive Officer required by Rule 13a-14(b) or Rule 15d-14(b)
under the Securities Exchange Act of 1934, as amended, and 18 U.S.C.
Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act
of 2002.
|
32.2
|
|
Certification
of Chief Financial Officer required by Rule 13a-14(b) or Rule 15d-14(b)
under the Securities Exchange Act of 1934, as amended, and 18 U.S.C.
Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act
of 2002.
|
(b) Reports
on Form 8-K
None
SIGNATURES
Pursuant
to the requirements of Section 13 or 15(d) of the Securities Exchange Act of
1934, the Registrant has duly caused this report to be signed on its behalf by
the undersigned, thereunto duly authorized.
CELLCEUTIX
CORPORATION
|
||
/s/
George W. Evans
|
||
George
W. Evans
|
||
Title:
|
Chairman,
Chief Executive Officer
|
|
(principal
executive officer)
|
||
/s/
Leo Ehrlich
|
||
Leo
Ehrlich
|
||
Title:
|
Chief
Financial Officer
|
|
(principal
financial officer)
|
||
Date:
|
May
17, 2010
|