U.S. SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-QSB/A
[X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
FOR THE QUARTERLY PERIOD ENDED: March 31, 2005
OR
[ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
COMMISSION FILE NUMBER: 333-43126
BIOACCELERATE HOLDINGS, INC.
(Exact name of registrant as specified in its charter)
NEVADA 87-0650219
- ---------------------------------- --------------
(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification No.)
712 Fifth Avenue, 19th Floor New York, NY 10019
-----------------------------------------------
(Address of principal executive offices)
(212) 897-6849
(Registrant's telephone number, including area code)
(Former name, former address and former fiscal year,
if changed since last report)
Check whether the issuer (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding
12 months (or for such shorter period that the registrant was required to file
such report(s), and (2) has been subject to such filing requirements for the
past 90 days. YES [X] NO [ ]
The number of $.001 par value common shares outstanding at June 2, 2005:
42,924,508
BIOACCELERATE HOLDINGS, INC
TABLE OF CONTENTS
Page
----
PART 1 - FINANCIAL INFORMATION
Item 1 Financial Statements (Unaudited) 3
Item 2 Management's Discussion and Analysis or Plan of Operations 12
Item 3 Controls and Procedures 20
PART II - OTHER INFORMATION
Item 1 Legal Proceedings 21
Item 2 Sales of Unregistered Equity Securities and Use of Proceeds 21
Item 3 Defaults Upon Senior Securities 21
Item 4 Submission of Matters to a Vote of Security Holders 21
Item 5 Other Information 21
Item 6 Exhibits 21
Signatures 22
-2-
PART I - FINANCIAL INFORMATION
-3-
Item 1. Financial Statements
These Financial Statements have not been reviewed by our Independent Registered
Public Accountants. The Company will be filing an amended restated 10QSB/A for
the period ending March 31, 2005 simultaneous with this filing.
BIOACCELERATE HOLDINGS, INC
(A Development Stage Company)
Consolidated Balance Sheet
(Unaudited) March 31, 2005
ASSETS
Current Assets
Cash and cash equivalents $ 791,618
Prepaid expenses 523,679
Accounts receivable 117,745
Other accounts receivable 77,373
-------------
Total Current Assets 1,510,415
-------------
Property and equipment, net 991,410
-------------
Other Assets
Other assets 983,473
Patents, net 601,072
Other long term investments 2,202,871
-------------
3,787,416
-------------
-------------
$ 6,289,241
=============
LIABILITIES AND STOCKHOLDERS' (DEFICIT)
Current Liabilities
Bank loans and overdrafts $ 713,665
Accounts payable 4,116,347
Accrued expenses 2,155,215
Due to related parties 379,200
Loans payable 9,719,602
Current portion of long-term debt 91,277
Other current liabilities 611,186
Deferred revenue 50,000
-------------
Total Current Liabilities 17,836,492
-------------
Deferred revenue 1,187,500
Long-term debt 5,226,665
-------------
6,414,165
-------------
Stockholders' (Deficit)
Preferred Stock, par value $.001; 10,000,000 shares authorized; --
none issued and outstanding
Common Stock, par value $.001; 100,000,000 shares authorized; 42,674
42,674,508 shares issued and outstanding
Additional paid in capital 167,876,627
(Deficit) accumulated in the development stage (185,504,744)
Other comprehensive Income (Loss)
Currency translation adjustment (375,973)
-------------
Total Stockholders' (Deficit) (17,961,416)
-------------
-------------
$ 6,289,241
=============
The accompanying notes are an integral part of these financial statements.
-4-
BIOACCELERATE HOLDINGS, INC
(A Development Stage Company)
Consolidated Statements of Operations
(Unaudited)
From Inception
Quarter Quarter November 1,
Ended Ended 1999 to
March 31 March 31 March 31
2005 2004 2005
-------------- -------------- --------------
Revenue $ 14,300 $ -- $ 14,300
Operating expenses
Research and development $ 3,628,363 $ -- $ 46,306,437
General and administrative 3,021,774 468,306 8,243,249
Non cash stock compensation - G&A 18,167,581 -- 82,668,287
-------------- -------------- --------------
Net operating (loss) (24,803,418) (468,306) (137,203,673)
-------------- -------------- --------------
Other income (expenses)
Interest and finance charges (105,160) -- (105,160)
Share of losses in affiliate -- 130,468 (362,441)
Non cash interest expense (36,931,308)
Minority interest share of losses in subsidiaries -- -- 6,981,408
Impairment charges (500,000) -- (17,883,570)
-------------- -------------- --------------
(605,160) 130,468 (48,311,071)
-------------- -------------- --------------
-------------- -------------- --------------
(Loss) attributable to common stockholders (25,408,578) (337,838) (187,759,744)
-------------- -------------- --------------
Other Comprehensive Income (Loss)
Foreign currency translation adjustments 97,275 -- (375,973)
-------------- -------------- --------------
TOTAL COMPREHENSIVE (LOSS) $ (25,311,303) $ (337,838) $ (185,504,744)
============== ============== ==============
Per share information - basic and diluted
Net (Loss) Per Common Share $ (0.63) $ (0.01)
-------------- --------------
Weighted Average Number of Shares Outstanding $ 40,137,637 $ 29,825,595
-------------- --------------
The accompanying notes are an integral part of these financial statements.
-5-
BIOACCELERATE HOLDINGS, INC.
(A Development Stage Company)
Consolidated Statement of Stockholders' (Deficit)
(Unaudited)
Period From Inception (November 1, 1999 ) to March 31, 2005
Other
Common Stock Additional
Shares Amount Paid In Capital
------------- ------------- -------------
Common shares issued for cash
at $.0008 per share 1,298,550 $ 1,000 $ --
Net (loss) for the period ended May 31, 2003 -- -- --
------------- ------------- -------------
Balances as of May 31, 2003 1,298,550 1,000 --
September 1, 2003 - Shares issued for
acquisition of Pharma Manufacturing
Services Limited at $.0008 per share 23,373,947 18,000 --
September 1, 2003 - Shares issued
for satisfaction of debt at $1.93 per share 811,612 811 1,561,724
Reclassification of paid in capital -- 5,673 (5,673)
February, 2004 - Shares issued net of funding
costs for cash at $.73 per share 6,622,605 6,623 4,810,158
February 2, 2004 - Additional paid in capital
relating to shares issued by
subsidiary companies -- -- 8,879,507
May, 2004 - Shares issued for cash net
of funding costs at $.77 per share 218,286 218 167,782
Net (loss) for the year ended May 31, 2004 -- -- --
Foreign currency translation adjustments -- -- --
------------- ------------- -------------
Balances as of May 31, 2004 32,325,000 32,325 15,413,498
------------- ------------- -------------
September 23, 2004 - Shares issued for the
net assets of Mobile Design Concepts, Inc. 1,375,086 1,375 23,444
December 2, 2004 - Shares issued for
services at $12.75 per share 2,275,804 2,276 29,014,226
December 2, 2004 - Shares issued for
satisfaction of debt and payables
of $3,818,471 at $12.75 per share 3,818,472 3,818 48,681,699
December 15, 2004 - Additional paid in capital
relating to share issuances by subsidiary
company -- -- 22,870,000
Shares issued for purchased research
and development 32,824,059
Net (loss) for the seven months
ended December 31, 2004 -- -- --
Foreign currency translation adjustments -- -- --
------------- ------------- -------------
Balances as of December 31, 2004 39,794,362 $ 39,794 $ 148,826,926
------------- ------------- -------------
February 7, 2005 - Shares issued
for services at $10.25 per share 41,667 42 427,045
March 21, 2005 - Shares issued for services
provided in relation to fundraising
at $6.25 per share 335,000 335 2,093,415
March 21, 2005 - Shares issued for
satisfaction of debt at $6.25 per share 2,503,479 2,503 15,644,241
Fair value of warrants issued by a subsidiary 885,000
Net (loss) for the three months
ended March 31, 2005 -- -- --
Foreign currency translation adjustments -- -- --
------------- ------------- -------------
Balances as of March 31, 2005 42,674,508 $ 42,674 $ 167,876,627
------------- ------------- -------------
Total
Accumulated Comprehensive Stockholders'
(Deficit) Income (Deficit)
------------- ------------- -------------
Common shares issued for cash
at $.0008 per share $ -- $ -- $ 1,000
Net (loss) for the period ended May 31, 2003 (848,664) -- (848,664)
------------- ------------- -------------
Balances as of May 31, 2003 (848,664) -- (847,664)
September 1, 2003 - Shares issued for
acquisition of Pharma Manufacturing
Services Limited at $.0008 per share -- -- 18,000
September 1, 2003 - Shares issued
for satisfaction of debt at $1.93 per share -- -- 1,562,535
Reclassification of paid in capital -- -- --
February, 2004 - Shares issued net of funding
costs for cash at $.73 per share -- -- 4,816,781
February 2, 2004 - Additional paid in capital
relating to shares issued by
subsidiary companies -- -- 8,879,507
May, 2004 - Shares issued for cash net
of funding costs at $.77 per share -- -- 168,000
Net (loss) for the year ended May 31, 2004 (2,100,238) -- (2,100,238)
Foreign currency translation adjustments -- (160,627) (160,627)
------------- ------------- -------------
Balances as of May 31, 2004 (2,948,902) (160,627) 12,336,294
------------- ------------- -------------
September 23, 2004 - Shares issued for the
net assets of Mobile Design Concepts, Inc. -- -- 24,819
December 2, 2004 - Shares issued for
services at $12.75 per share -- -- 29,016,502
December 2, 2004 - Shares issued for
satisfaction of debt and payables
of $3,818,471 at $12.75 per share -- -- 48,685,517
December 15, 2004 - Additional paid in capital
relating to share issuances by subsidiary
company -- -- 22,870,000
Shares issued for purchased research
and development 35,079,059
Net (loss) for the seven months
ended December 31, 2004 (157,147,264) -- (159,402,264)
Foreign currency translation adjustments -- (312,621) (312,621)
------------- ------------- -------------
Balances as of December 31, 2004 $(160,096,166) $ (473,248) $ (11,702,694)
------------- ------------- -------------
February 7, 2005 - Shares issued
for services at $10.25 per share 427,087
March 21, 2005 - Shares issued for services
provided in relation to fundraising
at $6.25 per share 2,093,750
March 21, 2005 - Shares issued for
satisfaction of debt at $6.25 per share 15,646,744
Fair value of warrants issued by a subsidiary 885,000
Net (loss) for the three months
ended March 31, 2005 (25,408,578) -- (25,408,578)
Foreign currency translation adjustments -- 97,275 97,275
------------- ------------- -------------
Balances as of March 31, 2005 $(185,504,744) $ (375,973) $ (17,961,416)
------------- ------------- -------------
The accompanying notes are an integral part of these financial statements.
-6-
BIOACCELERATE HOLDINGS, INC
(A Development Stage Company)
Consolidated Statements of Cash Flows
(Unaudited)
From Inception
Quarter Quarter November 1,
Ended Ended 1999 To
March 31, March 31, March 31,
2005 2004 2005
------------- ------------- --------------
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss $ (25,408,578) $ (598,774) $ (185,504,744)
Adjustments to reconcile net (loss) to net cash provided by
(used in) in operating activities:
Depreciation and amortisation 99,064 0 124,787
Issuance of common stock for services and interest 18,167,581 0 118,739,600
Addback decrease in deferred revenue (12,500) 0 (12,500)
Issuance of subsidiaries common stock for services 0 0 32,663,261
Impairment charges 500,000 0 17,883,570
Fair value of warrants issued by subsidiary 52,290 0 73,730
Changes in operating assets and liabilities:
Increase in accounts receivable (7,715) 0 (7,715)
(Increase) decrease in other current assets 19,229 0 339,940
Increase in other accounts receivable 69,589 (566,920) (206,633)
Increase in prepaid expenses (100,394) 0 (523,679)
Increase in accounts payable (121,117) 580,591 3,575,018
Increase (decrease) in accrued expenses 1,126,189 0 2,155,216
Increase in other current liabilities (362,170) (1,460,623) 3,566,963
------------- ------------- --------------
Net cash provided by (used in) operating activities $ (5,978,532) $ (2,045,726) $ (5,463,103)
------------- ------------- --------------
CASH FLOWS FROM INVESTMENT ACTIVITIES:
Purchase of long term investments (500,000) 0 (4,089,472)
Purchase of property and equipment (37,112) 0 (1,743,484)
Investment in affiliate 0 0 (4,001,815)
Payment for purchase of subsidiaries 0 0 (16,151,242)
- net of cash acquired
------------- ------------- --------------
Net cash (used in) investing activities (537,112) 0 (25,986,013)
------------- ------------- --------------
CASH FLOWS FROM FINANCING ACTIVITIES:
Issuance of common stock for cash 0 4,810,158 15,445,820
Bank overdraft 676,791 0 713,665
Proceeds from loans payable 5,790,340 0 16,929,668
------------- ------------- --------------
Net cash provided by financing activities 6,467,131 $ 4,810,158 $ 33,089,153
------------- ------------- --------------
Effect of changes in exchange rates 97,275 0 (375,973)
------------- ------------- --------------
Net increase (decrease) in cash and cash equivalents 48,762 2,764,432 791,618
Cash and cash equivalents at beginning of period $ 742,856 1,405,000 0
------------- ------------- --------------
Cash and cash equivalents at end of period 791,618 $ 4,169,432 $ 791,618
============= ============= ==============
Supplemental cash flow information:
Cash paid for interest $ 0 $ 0 $ 0
============= ============= ==============
Cash paid for income taxes $ 0 $ 0 $ 0
============= ============= ==============
Non cash investing and financing activities:
Settlement of debt and payables with common shares $ 0 $ 0 $ 3,818,472
============= ============= ==============
The accompanying notes are an integral part of these financial statements.
-7-
NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS
March 31, 2005
NOTE 1. NATURE OF THE BUSINESS
DESCRIPTION OF COMPANY: Bioaccelerate Holdings, Inc ("Bioaccelerate" or
"Company"), formerly Mobile Design Concepts, Inc. ("Mobile"), acquired
Bioaccelerate, Inc. ("BI") in an exchange of stock on September 23, 2004.
Simultaneously with the exchange of stock, Mobile Design Concepts, Inc. changed
its name to Bioaccelerate Holdings, Inc. Mobile was organized under the laws of
the State of Nevada on March 10, 2000. Mobile was formed to design, manufacture,
and lease mobile kiosks and other structures the operation was discontinued on
December 31, 2002.
The Company is examining opportunities in both start-up and emerging companies
in the biopharmaceutical sector.
The Company has not yet generated significant revenues and is considered a
development stage company as defined in Statement of Financial Accounting
Standards No.7. At the present time, the Company has not paid any dividends, and
any dividends that may be paid in the future will depend upon the financial
performance of its subsidiary, Bioaccelerate, Inc.
BI was organized under the laws of the State of Delaware on December 29, 1995 as
Tallman Supply Corp. On January 14, 1999 the Company changed its name to
Westminster Auto Retailers, Inc. On July 25, 2003 the Company changed its name
to Bioaccelerate, Inc.
BI has not generated revenue and is considered a development stage company as
defined in Statement of Financial Accounting Standards No. 7. On August 31, 2003
the holders of Bioaccelerate common stock agreed to a 5 for 1 reverse split of
all of its outstanding shares. This reduced the amount of common stock
outstanding from 5 million to 1 million shares. BI acquired Pharma Manufacturing
Services Limited ("PMSL") on September 1, 2003 and issued 18,000,000 (post
reverse split) shares to PMSL shareholders. The effect was to transfer
operational control of BI to the former shareholders and directors of PMSL,
making PMSL the acquirer for accounting purposes. PMSL subsequently changed its
name to Bioaccelerate Limited.
As a result of the share exchange between the Company and BI, the shareholders
of BI have received 32,325,000 shares of stock, or 95.9% of the issued and
outstanding common stock, and the shareholders of the Company retained 1,375,085
shares. BI will continue in the same business that it was engaged in prior to
the share exchange, and all of the officers and directors of BI in office at the
time of the share exchange continue in those roles with the Company. Since
ownership and operational control of the Company is considered to have passed to
the stockholders and management of BI, BI is treated as the entity that acquired
the assets of the Company for accounting purposes. In accordance with Statement
of Accounting Standards No. 141, the acquisition of assets will be accounted for
using the purchase method.
The Company was formed to capitalize on opportunities in the biopharmaceutical
market through the development of compounds and also companies that will
commercialize those compounds. The Company acquires and develops pharmaceutical
assets, both corporate and physical.
The Company currently holds 23,857,000 common shares, representing 49.1 % of
Evolve Oncology, Inc total issued stock at March 31, 2005 , and consolidates its
results in the financial statements The Company also holds 5,000,000 warrants
for common stock at an exercise price of $2.60.
The Company holds 12,169,260 common shares, representing 22.4% of Enhance
Biotech Inc total issued stock at March 31, 2005 and consolidates its results in
the financial statements. The company also holds 1,500,000 warrants for common
stock at an exercise price of $3.00.
On March 31, 2005 the Company held 11,997,900 common shares or 90% in Oncbio,
Inc and 15,900,000 common shares or 89% in Innovate Oncology, Inc carried at nil
value in the financial statements, together with 5,000,000 options at an
exercise price of $0.65 and 1,000,000 options at an exercise price of $1.00
respectively.
The Company's investments of 2,000,000 common shares in Advanced Nanotech Inc
(formerly Artwork and Beyond, Inc are carried in the balance sheet at cost.
The Company's investment in Llama Biotech Ltd is carried at cost of $11,788 ,
the investment in JPS Holdings, Inc and 3,928,804 common shares Neuro
Bioscience, Inc are carried at nil value .Its investment in Australian Cancer
Technologies is held in the Company's balance sheet at $191,083 after provision
for impairment..
The market value of the Company's holdings in quoted stocks as at March 31, 2005
was approximately $340,000,000 based upon closing prices as at March 31, 2005.
However this value may not be realizable since most stock held is currently
subject to restrictions and there is limited liquidity in these companies'
shares at present.
-8-
BIOACCELERATE HOLDINGS, INC.
(A Development Stage Company)
NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS
March 31, 2005
NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES
A. BASIS OF PRESENTATION: These consolidated financial statements include the
accounts of Bioaccelerate Holdings, Inc. and its subsidiaries (the Company),
with appropriate eliminations of inter-company balances and transactions. The
financial statements are prepared by the Company on the accrual basis of
accounting in accordance with the rules and regulations of the Securities and
Exchange Commission for interim financial information, and in accordance with
the instructions for form 10Q and Article 10 of Regulation S-X. Accordingly,
revenue is recognized when earned, and expenses when incurred.
Certain information and footnote disclosures normally included in the Company's
annual audited financial statements, as required by accounting principles
generally accepted in the United States, have been condensed or omitted. The
interim condensed financial statements, in the opinion of management, reflect
all adjustments, consisting entirely of normal recurring adjustments, necessary
for a fair presentation of the Company's financial position as of March 31,2005
The results of operations for the interim periods are not necessarily indicative
of the results of operations to be expected for the entire fiscal year. These
interim condensed financial statements should be read in conjunction with the
audited financial statements for the period ended December 31, 2004, filed with
the Securities and Exchange Commission..
B. USE OF ESTIMATES: The preparation of financial statements in conformity with
generally accepted accounting principles in the United in the opinion of
management, reflect all adjustments, consisting entirely of normal recurring
adjustments, necessary for a fair presentation of the Company's financial
position as of March 31,2005 The results of operations for the interim periods
are not necessarily indicative of the results of operations to be expected for
the entire fiscal year. These interim condensed financial statements should be
read in conjunction with the audited financial statements for the period ended
December 31, 2004, filed with the Securities and Exchange Commission..States
requires management to make estimates and assumptions that affect the reported
assets and liabilities, disclosure of contingent assets and liabilities at the
date of the financial statements, and the reported amount of revenues and
expenses during the reporting period. Actual reports may differ from these
estimates. Significant estimates in the financial statements include the
assumption that the Company will continue as a going concern.
C. CERTAIN RISKS AND UNCERTAINTIES: The Company is subject to risks common to
companies in its industry, including, but not limited to, new technological
innovations, dependence on key personnel, protection of proprietary technology,
compliance with government regulations, uncertainty of market acceptance of
products, product liability and the need to obtain financing.
D. PRINCIPLES OF CONSOLIDATION: The consolidated financial statements include
the accounts of the following companies:
Amilar Pharma Inc
Anvira Inc
Bioaccelerate Holdings, Inc (formerly Mobile Design Concepts, Inc)
Bioaccelerate, Inc
Bioaccelerate Limited
Biocardio Inc
CNS Thera Inc
Cynat Onclogy Inc
Enhance Biotech, Inc
Evolve Oncology, Inc
Genar Oncology Inc
Inncardio, Inc
Innova Lifestyle, Inc
Innovate Oncology, Inc
Oncbio Inc
-9-
The consolidated financial statements include the assets and liabilities of the
majority owned subsidiaries, adjusted to allow for minority interests. All
significant intercompany transactions have been eliminated.
E. CONCENTRATIONS OF CREDIT RISK: The Company has no significant off balance
sheet concentrations of credit risk such as foreign exchange contracts, option
contracts or other foreign hedging arrangements.
F. CASH AND CASH EQUIVALENTS: For the purpose of these financial statements, the
Company considers all highly liquid debt instruments purchased and realizable
within three months or less to be cash equivalents to the extent that they are
not held for investment purposes.
BIOACCELERATE HOLDINGS, INC.
(A Development Stage Company)
NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS
March 31, 2005
NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES
(Continued)
G. MARKETABLE SECURITIES: The Company will classify its holdings of free trading
shares as marketable securities available for sale in accordance with the
Statement of Financial Accounting Standard ("SFAS") No.115, "Accounting for
Certain Investment in Debt and Equity Securities". The marketable securities
will be reported at fair value with unrealized gains and losses recorded as a
separate component of accumulated other comprehensive income and loss in
stockholders's equity net of taxes. The specific identification method is used
to determine gains and losses when securities are sold. A decline in the market
value below cost that is deemed to be other than temporary would result in a
change to earnings in the period the decline occurs. Currently the Company's
holdings of quoted shares are restricted and have been included in the financial
statements at cost
H. FAIR VALUE OF FINANCIAL INSTRUMENTS: The carrying amounts of certain of the
Company's financial instruments, including cash and cash equivalents and
accounts payable approximate fair value due to their short maturities. Based on
borrowing rates currently available to the Company for loans with similar terms,
the carrying value of its debt obligations approximate fair value.
I. RESEARCH AND DEVELOPMENT: Costs and expenses that are clearly identified as
research and development are charged to expense as incurred in accordance with
FASB Statement No. 2 "Accounting for Research and Development ".
J. FOREIGN CURRENCY TRANSLATION: A number of the Company's subsidiaries have the
British Pound as a primary functional currency . Assets and liabilities are
translated using the exchange rates in effect at the balance sheet date.
Expenses are translated at the average exchange rates prevailing during the
year. Translation gains or losses not reflected in earnings are reported in
accumulated other comprehensive losses in the stockholder's equity.
K. DEPRECIATION POLICY: The Company depreciates its assets on a straight line
basis over their useful lives on the following basis: furniture and fixtures, 10
years; computer equipment, 4 years; and leasehold improvements, 3 years.
Intangible assets are subject to review for impairment as required under SFAS
144.
L. MINORITY INTERESTS: Minority interests represent the interest of third
parties in the net assets of certain subsidiary companies.
M. LONG-LIVED ASSETS: The Company periodically reviews the value of long-lived
assets for impairment whenever events or changes in business circumstances
indicate that the carrying amount of the assets may not be fully recoverable or
that the useful lives of these assets are no longer appropriate. Each impairment
test is based on a comparison of the future undiscounted cash flows arising from
the assets with the carrying value of the asset. If impairment is indicated, the
asset is written down to its estimated fair value on a discounted cash flow
basis.
N. INCOME TAXES: The Company accounts for income taxes under the provisions of
SFAS No. 109, "Accounting for Income Taxes." SFAS No.109 requires recognition of
deferred income tax assets and liabilities for the expected future income tax
consequences, based on enacted tax laws, of temporary differences between the
financial reporting and tax bases of assets and liabilities.
-10-
O. NET LOSS PER SHARE: Basic loss per share has been computed by dividing the
loss for the year applicable to the common stockholders by the weighted average
number of common shares outstanding during the year.
NOTE 3 - NON-CASH FINANCIAL TRANSACTIONS
Non-cash financing transactions including the cost of contributed services,
contributed rent, and additional paid in capital contributed by shareholders
have been included in expenses and additional paid in capital, respectively in
the accompanying financial statements.
NOTE 4 - LEGAL MATTERS
As of the date of this report the Directors have no knowledge of any pending or
threatened legal proceedings.
BIOACCELERATE HOLDINGS, INC.
(A Development Stage Company)
NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS
March 31, 2005
NOTE 5 - LOANS PAYABLE
BI has a total of $9,719,602 in loans secured by all the assets and future
assets of the company with an interest rate equal to the Applicable Federal
Rate, as defined in Section 1247(d) of the Internal Revenue Code.An amount of
$7,415,042 has been drawn against a facility of $7.5 million provided by
Technology Finance, Inc. As of March 31, 2005 the interest rate was 4.0%. The
Company has a further two credit facilities for $12.5million each with
Lifescience Ventures Ltd and Jano Holdings Ltd and has drawn down $2,304,560 on
the Jano facility. As of March 31, 2005 the interest rate was 4.0%.
NOTE 6 INVESTMENT IN AFFILIATES
Evolve Oncology
At March 31, 2005, the Company owned a 49.15% interest in Evolve. For accounting
purposes, the Company is treating its capital investment in Evolve as a vehicle
for research and development. Because the Company is solely providing financial
support to further the research and development of Evolve, such amounts are
being charged to expense as incurred by Evolve since Evolve presently has no
ability to fund these activities and is dependent on the Company to fund its
operations. In these circumstances, Evolve is considered a variable interest
entity and has been consolidated. The creditors of Evolve do not have recourse
to the general credit of the Company. Through March 31, 2005, the Company
advanced Evolve an aggregate of $1,296,632.
A summary of financial position and results of operations of Evolve as of March
31, 2005, and the quarter then ended is as follows:
Current assets $ --
Property and equipment 98,000
-----------
$ 98,000
Current liabilities $ 2,455,139
Stockholders' (deficit) (2,357,139)
-----------
$ 98,000
Sales $ --
===========
Net Income $ --
===========
Minority interest in Income $ --
===========
-11-
Enhance Biotech
At March 31, 2005, the Company owned a 22.4% interest in Enhance Biotech, Inc.
("Enhance"). For accounting purposes, the Company is treating its capital
investment in Enhance as a vehicle for research and development. Because the
Company is solely providing financial support to further the research and
development of Enhance, such amounts are being charged to expense as incurred by
Enhance since Enhance presently has no ability to fund these activities and is
dependent on the Company to fund its operations. In these circumstances, Enhance
is considered a variable interest entity and has been consolidated. The
creditors of Enhance do not have recourse to the general credit of the Company.
Through March 31, 2005, the Company advanced Enhance an aggregate of $2,691,908.
A summary of financial position and results of operations of Enhance at March
31, 2005, is as follows:
Current assets $ 519,197
Property and equipment 715,184
Other assets 1,584,545
-----------
$ 2,818,926
Current liabilities $ 5,595,610
Long-term liabilities 3,154,165
Stockholders'(deficit) (5,930,849)
$ 2,818,926
Sales $ --
===========
Net loss $(1,883,300)
===========
BIOACCELERATE HOLDINGS, INC.
(A Development Stage Company)
NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS
March 31, 2005
NOTE 7 - STOCKHOLDERS' EQUITY
On February 7, 2005 the company issued 41,667 shares of Common Stock for
services the share price was $10.25 and valued the issues at $427,087
On March 21,2005 the company issued 335,000 of Common Stock for services
connected with fundraising the share price was $6.25 valuing the transaction at
$2,093,750
On March 21,2005 the company issued 2,503,479 shares of Common Stock in
connection with an acquisition of Pharma Manufacturing Services Limit the shares
price was $6.25 valuing the transaction at $15,646,744
NOTE 8 - COMMITMENTS AND CONTINGENCIES
The Company has offices in New York and London, England.
Bioaccelerate, Inc. holds a license to occupy 1,000 square feet of office space
at 712 Fifth Avenue, 19th Floor, New York, New York 10019 at a gross cost of
$27,000 per month.
Bioaccelerate Limited occupies 5,000 square feet of office space at Savannah
House, Charles II Street, London. The premises are held on a three-year lease
from July 28, 2004.
On July 6, 2004 Bioaccelerate Inc provided a credit facility to Evolve Oncology,
Inc of $5,000,000 repayable on the closing of a debt or equity financing in
which the Evolve receives at least $10,000,000 in gross proceeds. The facility
accrues interest on the outstanding balance at the Applicable Federal Base Rate.
The company received 5,000,000 warrants convertible into common stock at an
exercise price of $2.60 on the commencement of the facility agreement. On March
31, 2005 the closing market price of the shares was $9.00 creating an unrealized
pre-tax profit of $32,000,000 which has not been included in the Balance Sheet.
On July 15, 2004 Bioaccelerate Inc provided a credit facility to Oncbio, Inc of
$5,000,000 repayable on the closing of a debt or equity financing in which the
Oncbio receives at least $10,000,000 in gross proceeds. The facility accrues
interest on the outstanding balance at the Applicable Federal Base Rate. The
company received 5,000,000 warrants convertible into common stock at an exercise
price of $0.65 on the commencement of the facility agreement . On March 31, 2005
the closing market price of the shares was $0.85 creating an unrealized pre-tax
profit of $1,000,000 which has not been included in the Balance Sheet.
-12-
On July 22, 2004 Bioaccelerate Inc provided a credit facility to Innovate
Oncology, Inc of $5,000,000 repayable on the closing of a debt or equity
financing in which the Innovate Oncology receives at least $10,000,000 in gross
proceeds. The facility accrues interest on the outstanding capital at the
Applicable Federal Base Rate. The company received 1,000,000 warrants
convertible into common stock at an exercise price of $1.00 on the commencement
of the facility agreement. On March 31, 2005 the closing market price of the
shares was $5.00 creating an unrealized pre-tax profit of $4,000,000 which has
not been included in the Balance sheet.
On August 9th, 2004 Bioaccelerate Inc provided a credit facility to Neuro
Bioscience, Inc of $1,225,000 repayable on the closing of a debt or equity
financing in which the Neuro Bioscience receives at least $10,000,000 in gross
proceeds. The facility accrues interest on the outstanding balance at the
Applicable Federal Base Rate. The company received 2,400,000 shares of common
stock on the commencement of the facility agreement.
On August 11, 2004 Bioaccelerate Inc provided a credit facility to Enhance
Biotech, Inc of $6,000,000 repayable on the closing of a debt or equity
financing in which the Enhance receives at least $10,000,000 in gross proceeds.
The facility attracts interest on the outstanding capital at the Applicable
Federal Base Rate. The company received 1,500,000 warrants convertible into
common stock at an exercise price of $3.00 on the commencement of the facility
agreement. On March 31, 2005 the closing market price of the shares was $1.30.
On March 9,2005 Bioaccelerate Inc provided a credit facility to Inncardio, Inc
of $12,000,000 repayable on the closing of a debt or equity financing in which
Inncardio, Inc receives at least $20,000,000 in gross proceeds.
-13-
BIOACCELERATE HOLDINGS, INC.
(A Development Stage Company)
NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS
March 31, 2005
NOTE 9 - INCOME TAXES
Where applicable, deferred income taxes are recognized for the extended future
tax consequences attributable to the increased value of marketable securities
and for realized gains on securities sold.
NOTE 10 SUBSEQUENT EVENTS
On April 6, 2005, the Company filed a Definitive Information Statement
disclosing that the Directors and majority of common stock holders had approved
an amendment to the Company's Certificate of Incorporation to increase the
number of authorized shares of common stock of the Company par value $0.001from
50 million to 100 million shares and the increase the number of authorized
shares of preferred stock par value $0.001 of the Company from 1 million shares
to 10 million shares.
Recent Accounting Pronouncements
The Financial Accounting Standards Board (FASB) issues various accounting
standards and interpretations that could have an impact on the Company's
consolidated financial statements. Recent pronouncements include: FASB Statement
144 - Accounting for the impairment or disposal of long-lived assets; FASB 145 -
Rescission of FASB Statements 4, 44 and 64 and amendment of FASB 13; FASB 146 -
Costs associated with exit or disposal activities; FASB 148 - Accounting for
stock based compensation and FASB 150 - Accounting for certain financial
instruments with characteristics of both liabilities and equity. FIN 46 -
Consolidation of Variable Interest Entities, an interpretation of ARB 51.
Adoption of these standards and interpretations has not had a material effect on
the Company's financial condition, results of operations or liquidity.
On December 16, 2004 the FASB issued SFAS No. 123R, "Share-Based Payment," which
is an amendment to SFAS No. 123, "Accounting for Stock-Based Compensation." This
new standard eliminates the ability to account for share-based compensation
transactions using Accounting Principles Board, or APB, Opinion No. 25,
"Accounting for Stock Issued to Employees," and generally requires such
transactions be accounted for using a fair-value-based method and the resulting
cost recognized in our financial statements. This new standard is effective for
awards that are granted, modified or settled in cash in interim and annual
periods beginning after June 15, 2005, December 15, 2005 for small business
issuers. In addition, this statement will apply to unvested options granted
prior to the effective date. The Company will adopt this new standard effective
for the first fiscal quarter of 2006 and it has not yet determined what impact
this standard will have on its financial position or results of operations.
In November 2004, the FASB issued SFAS No. 151, "Inventory Costs: an amendment
of ARB No. 43, Chapter 4," to clarify the accounting for abnormal amounts of
idle facility expense, freight, handling costs and wasted material. SFAS No. 151
is effective for inventory costs incurred during fiscal years beginning after
June 15, 2005. We do not believe the provisions of SFAS No. 151, when applied,
will have a material impact on our financial position or results of operations."
Item 2: Management's Discussion & Analysis or Plan of Operations
FORWARD LOOKING STATEMENTS: NO ASSURANCES INTENDED
This disclosure contains forward-looking statements. The forward-looking
statements include all statements that are not statement of historical fact. The
forward-looking statements are often identifiable by the use of words such as
"may," "expect," "believe," "anticipate," "intend," "could," "estimate," "seek,"
"contemplate," "hope," "suggest," "envision," or "continue," or comparable
language, or the negative or other variation of those or comparable terms. Our
actual results could differ materially from the anticipated results described
with forward-looking statements. These forward-looking statement are based
largely on our expectation and are subject to a number of risks and
uncertainties, including but not limited to: those risks associated with out
ability to identify and raise additional capital to complete our product
development programs; our allocation of resources as necessary to continue
operations; our ability to generate cash flow from revenue or other sources; our
ability to use our capital stock for acquisitions, paying expenses or other
disbursements, attracting personnel or contracts and other business uses. Many
of these factors are beyond our management's control. These uncertainties could
cause our actual results to differ materially from the expectations reflected in
these forward-looking statements. In light of these risks and uncertainties, we
cannot be certain that the forward- looking information contained herein will,
in fact, occur. Interested persons should consider carefully the previously
stated factors as well as the more detailed information contained elsewhere
herein.
-14-
Plan of Operations.
Business
Bioaccelerate (or "The Company") acquires and develops pharmaceutical compounds
that have substantial medical and commercial value. The companies in which
Bioaccelerate currently has interests focus on five vertical therapeutic areas;
Oncology, Specialty Pharma, Central Nervous System, Cardiovascular and
Infection. These therapeutic areas represent a current combined market
opportunity in excess of $250 billion.
Reducing risk, accelerating speed to market
Bioaccelerate uses a virtual development network to accelerate the development
of multiple early stage compounds to Phase II/III clinical development. The
Company believes that this strategy creates a lower risk business model, since
its network enables the timely and cost effective passage from the discovery
process up to Phase II/III where substantial incremental value is created.
Innovation complemented by a diverse partner network
Bioaccelerate's innovative approach focuses on the use of latest technologies to
cut development costs and reduce the amount of time that a drug spends in
development. Bioaccelerate's key objective is to create value through its
aggressive development of existing companies and compounds, as well as;
o Identifying additional compounds for portfolio companies;
o Entering into partnering, co-development and marketing agreements with
large pharmaceutical and other biotech companies, speeding time to market
for the compounds being developed;
o Using industry expertise, business contacts and insights of in-house
scientific and business management to develop synergies and establish
collaborative agreements;
o Orchestrating a network of development resource to ensure efficiency in
the development process;
o Creating substantial shareholder value through the development of existing
and further portfolio companies, via the deep asset base of identified
compounds that Bioaccelerate has access to via established relationships.
A strategic approach to creating value
Large pharmaceutical companies need additional products to fill depleted
pipelines. Bioaccelerate believes it has developed a cost effective process
which provides a link between early stage drug candidates and large
pharmaceutical companies. Currently, funding is increasingly only available from
the capital markets for later stage companies. Bioaccelerate develops and
consolidates multiple early stage products in standalone companies in vertical
therapeutic areas until critical mass and development milestones are achieved.
At this stage the company is then ready to access further funding from the
capital markets. This affords orphan/individual technologies an opportunity to
be developed while giving academic institutions and scientists access to
development capital for early stage compounds. Bioaccelerate's drug development
strategy includes in-licensing compounds from various academic, research and
medical centers where the company has developed extensive relationships.
Bioaccelerate is constantly reviewing these development opportunities to
establish which products offer the best strategic fit with other companies in
its portfolio.
A proven depth of expertise
Bioaccelerate has a proven management team with a broad base of experience in
pharmaceutical & biotechnology companies as well as capital markets. The
management team is responsible for company-wide initiatives, significant
operating decisions and policymaking. This team works alongside a scientific
advisory board whose function is to advise the Company on scientific aspects of
product selection and development. Bioaccelerate conducts its business directly
and through its subsidiaries. Bioaccelerate Holdings inc. currently holds 100%
of Bioaccelerate inc. ,Bioaccelerate Ltd. and Bioaccelerate Ltd (BVI), and
through these subsidiaries a significant equity interest in the following
thirteen biotech companies:
Oncology: Evolve Oncology, Inc. (49.1%), Genar Oncology, Inc.
(94%), Innovate Oncology, Inc. (90%), OncBio, Inc.
(90%) Cynat Oncology, Inc. (94%)
Specialty Pharma: Innova Lifestyle, Inc. (94%),
Amilar Pharmaceuticals Inc, (94%)
Enhance Biotech, Inc. (22.4%)
Central Nervous System: CNS Thera, Inc. (94%), NeuroBioscience, Inc (19%),
Cardiovascular disease: InnCardio, Inc. (94%) BioCardio, Inc. (50 %)
Anti-infective: Anvira, Inc. (94%)
-15-
The Company also has investments in Advance Nanotech Inc (AVNA.OB), Australian
Cancer Technologies Ltd (ACU.AX), JPS Holdings, Inc and Llama Biotech Ltd
Our management believes that large pharmaceutical companies need additional
drugs to fill depleted drug development pipelines, particularly since many
existing products of large pharmaceutical companies will soon be losing patent
protection. Increasingly those companies seek to fill that gap by in-licensing
drugs at the middle to late stages of development rather than acquiring
compounds at an earlier stage. We believe that the large in-house basic and
applied research staffs of those large pharmaceutical companies increase the
overhead of those companies and may also engender institutional resistance to
acquisition or development of in- licensed drugs, resulting in costs and delays
in development of new drugs by those companies. It also appears to us that that
many individual scientists and medical research institutions may lack the
expertise or resources to develop promising early stage drug candidates.
Bioaccelerate's business goal is to act as a cost-effective pharmaceutical
development organization, identifying commercially viable early-stage compounds
from academic, research and medical centers where Bioaccelerate has forged
strong relationships, and utilizing our expedited product development structure
to provide a cost-effective link between early-stage drug candidates and large
pharmaceutical companies. Bioaccelerate achieves its value by providing
management expertise and funding to develop the products assigned to its
portfolio companies and achieves shareholder value by taking the portfolio
companies public and benefiting from the upside in share price of those
portfolio companies as and when milestones are achieved in the development of
the compounds.
Strategy
Bioaccelerate and its subsidiaries select, in-license and group, early- stage
compounds which their respective managements deem promising in the stand-alone
companies which Bioaccelerate has organized by vertical therapeutic areas.
Bioaccelerate may utilize its own resources for the initial operations of a
newly-formed subsidiary, including its initial in- licensing. However, when a
subsidiary company's product pipeline reaches critical mass and achieves certain
development milestones, it is intended that the subsidiary company will seek
additional funding from the capital markets on its own. Since funding is often
only available for later-stage compounds, Bioaccelerate's development resources
make it possible for academic institutions and scientists to pursue early- and
mid-stage develop of orphaned compounds and technology.
Bioaccelerate generally favors in-licensing compounds in the early- to mid-
stages of development to reduce the risks and costs associated with new
molecular entity (NME) and new chemical entity (NCE) development. Bioaccelerate
will continue to advance its clinical development strategy, balancing
in-licensing and reformulations with NME and NCE development when it feels it is
appropriate.
Bioaccelerate enters into development, marketing and partnership agreements with
laboratories, industry experts and large pharmaceutical companies to develop,
test and seek regulatory approval for drug candidates. By relying primarily upon
contracts with third parties for research, clinical development and project
management rather than doing that work in-house, Bioaccelerate is able to
maintain a limited infrastructure, particularly as compared with large
pharmaceutical companies. Our management believes that this strategy offers a
lower risk model for achieving incremental value for investors in new drug
products, allows us to accelerate the time it takes for new products to reach
the critical Phase II/III clinical trials level, and creates an efficient and
cost-effective route from discovery to commercializing a product.
Research and Development
The structure of our research and development activity is designed to enable the
best choices to be made as to where and how the projects are run and resourced.
Each is managed as a discreet project with its own budget and project manager.
Where and when possible projects make common use of the resources and contracted
facilities enlisted at each stage. We manage our projects through ongoing review
of scientific data, making use of our broadly experienced Management and
Scientific Advisory Board to assist in this process and by supplementing these
programs with our cost allocations as required to move toward regulatory
approval. Our cost allocations are based primarily on pre-established
development budgets set out in our agreements with research and co-development
partners. Costs attributed to Research and Preclinical projects largely
represent our pipeline generating activities. See Item 6. "Management Discussion
and Analysis of Financial Condition and Results of Operations" for further
discussion of research and development spending trends.
-16-
OUR PRODUCT DEVELOPMENT PORTFOLIO AND PIPELINE
1. ONCOLOGY
Oncology is the therapeutic market with the largest portfolio of products in
development by Bioaccelerate and its subsidiaries. Reuters Business Insight
forecasts the global cancer treatment market to grow from $34.3 billion in 2002
to $42.8 billion in 2007. Their research also indicates that the innovative
cancer therapy market will triple from $4.3 billion in 2001 to $12.3 billion in
2007.
OUR PRODUCT DEVELOPMENT PORTFOLIO AND PIPELINE
(Continued)
EVOLVE ONCOLOGY. Evolve Oncology seeks to acquire, develop and commercialize
drugs to treat various types of cancer and cancer pain management. Evolve
Oncology's product development portfolio targets lung, breast and other types of
cancer. Evolve Oncology's management believes its focus on innovative treatments
should benefit from the market opportunity created by multiple patent
expirations, particularly in hormonal and cytostatic therapies facing the large
pharmaceutical companies. Bioaccelerate will also seek to develop niche drugs
passed over by large pharmaceutical companies.
ONCBIO. OncBio seeks to acquire, develop and commercialize drugs to treat
multiple cancers such as breast, lung and chronic myelogenous leukemia. OncBio's
product development pipeline focuses on new, innovative compounds as well as
enhanced formulations of existing compounds.
GENAR ONCOLOGY. Genar Oncology seeks to acquire, develop and commercialize a
broad platform of compounds to fight cancers. Bioaccelerate's product
development portfolio targets multiple cancers, such as a single product one for
solid tumors prevalent in breast, lung and colorectal cancer. Management
believes these multiple-use products will enhance the drugs' value in the
marketplace.
INNOVATE ONCOLOGY. Innovate Oncology seeks to acquire, develop and commercialize
compounds targeted at multiple cancers and oncology-related conditions. Some of
the oncology related conditions we seek to address are reversing chemo
resistance and treating common side effects such as nausea and vomiting.
Innovate Oncology's pre-clinical product development portfolio is all based upon
scientific approaches which our management believes are innovative.
Bioaccelerate through it's subsidiaries is developing a platform of compounds
which have been selected to target multiple cancers, instead of focusing on only
one specific disease area. This approach management believes will enhance the
compounds future values and give the drugs a greater chance of success.
2. SPECIALTY PHARMA
The specialty pharma segment of the global pharmaceutical marketplace is
projected to grow from $22.9 billion in 2002 to $29 billion by 2007, according
to Reuters Business Insight. Bioaccelerate's management believes its three
lifestyle drug subsidiary companies are poised to take advantage of some of the
most potentially lucrative segments, including sexual dysfunction, skin diseases
and addiction.
ENHANCE BIOTECH. Enhance Biotech acquires, develops and commercializes drugs to
treat lifestyle disorders. Enhance's portfolio of seven products under
development target male sexual dysfunction and dermatology, two of the seven
major therapeutic segments in the lifestyle drug market. Enhance's lead product
targets premature ejaculation, which is the most widespread indication in male
sexual dysfunction (MSD). The disorder affects 29% of the adult male population
and represents a potential $6 billion market, according to Reuters Business
Insight.
Enhance Biotech recently acquired Ardent Pharmaceuticals Inc., a privately held
biotechnology company with an extensive research and development pipeline that
includes a number of pre- clinical and clinical drug candidates in the areas of
moderate to severe pain, urinary incontinence, premature ejaculation, depression
and cardio protection. Pursuant to the merger agreement, Ardent became a wholly-
owned subsidiary of Enhance Biotech and the former Ardent stockholders received
Enhance Biotech securities amounting, on a fully- diluted basis, to 45% of
Enhance Biotech's outstanding equity securities, post- merger. Shareholders of
Enhance Biotech own 55 % of the merged entity.
INNOVA LIFESTYLE. Innova Lifestyle seeks to acquire, develop and commercialize
drugs for lifestyle disorders including acne, alcohol addiction and female
sexual dysfunction. Awareness has been increasing about the need for effective
and safe female stimulants to treat female sexual dysfunction. Analysts at
Reuters Business Insight say this disorder is still poorly defined and
understood, evidenced by their research that indicates that between 19% and 43%
of women in the general population suffer from sexual dysfunction. Despite that
prevalence, only 26% of women across the major markets seek treatment.
Bioaccelerate believes treatment for female sexual dysfunction may be a major
market opportunity following in the footsteps of the strong public response to
male erectile and premature dysfunction treatments coming to market now.
AMILAR PHARMACEUTICALS. Amilar Pharmaceuticals seeks to acquire, develop and
commercialize drugs to treat lifestyle disorders. Bioaccelerate's portfolio of
products under development concentrates on treatments for alcohol addiction,
osteoarthritis, interstitial cystitis, osteoarthritis and irritable bowel
syndrome. Alcohol addiction affects a patient population of 47 out of every 1000
adults. The current market for this product is estimated to be $300 million.
-17-
3. CENTRAL NERVOUS SYSTEM
The worldwide population with CNS disorders is rising steadily. This increase is
being driven by an aging population, improving diagnostic techniques, increasing
physician and patient awareness and a gradual shift away from the social stigma
traditionally attached to many psychiatric conditions. As the prevalence of CNS
disorders rises, so does the cost. In the U.S., it is estimated that more than
20% of healthcare spending is directed towards CNS-related disorders, according
to Reuters Business Insight. Alzheimer's disease alone is estimated to cost the
U.S. economy $100 billion annually, with a prevalent population of more than 4
million. Bioaccelerate is seeking to tap the potential in this market by
developing subsidiaries with diversified products to target the broad range of
CNS diseases.
CNS THERA. CNS Thera seeks to acquire, develop and commercialize compounds
targeted against various central nervous system disorders. Bioaccelerate's
portfolio of products under development focuses on some of the largest potential
markets such as Alzheimer's disease, epilepsy, multiple sclerosis and
Parkinson's disease.
4. CARDIOVASCULAR DISEASE
Among the cardiovascular diseases, a disorder of lipid metabolism called
dyslipidemics has had the fastest growth in global sales. In 2002, the global
anti-dyslipidemics market generated sales of $21.86 billion and Reuters Business
Insight forecasts annual sales to rise to $32.6 billion by 2008. Dyslipidemics
is often used as a blanket term to describe any imbalance in the level of blood
lipids (fats) and a variety of conditions characterized by either excessively
high or excessively low levels of certain lipids in the bloodstream, including
cholesterol and triglycerides. Within cardiovascular disease,
hypercholester-olemia is the most common risk, with an average prevalence rate
of 43.8% in the seven major markets.
BIOCARDIO. Biocardio seeks to acquire, develop and commercialize therapies to
treat cardiovascular and metabolic diseases. Bioaccelerate's products under
development target heart disease, cholesterol imbalances and chronic obstructive
pulmonary disorder (COPD). COPD is lung damage caused by smoking and has the
third largest burden of disease in the world. Bioaccelerate believes its novel
therapy, if successfully developed and approved, will fill a largely unmet need
for treatment.
INNCARDIO. Inncardio seeks to acquire, develop and commercialize therapies to
treat cardiovascular and metabolic diseases including diabetes, artherosclerosis
and myocardial ischemia. Approximately 60 million people in seven major markets
suffer from diabetes, 17 million in the U.S. alone.
5. ANTI-INFECTIVES
The global anti-virals market, which is a subset of anti-infective, is forecast
to grow from $8.7 billion in 2001 to $14 billion in 2007, according to Reuters
Business Insight. Much of that growth comes from the high incidence of viral
infections and currently available drugs that are not efficacious. Another
growth factor for this therapeutic area is a strategy by big pharmaceutical
companies that increasingly target patients in developing countries.
Bioaccelerate believes this change creates an opportunity to develop its
anti-infective portfolio.
ANVIRA. Anvira seeks to acquire, develop and commercialize anti- infective
products for common diseases such as ear and throat infections as well as
pneumonia and bronchitis. Bioaccelerate's current portfolio of products under
development consists of reformulations of off- patent anti- infectives.
Product Development
A major element of the Company's product development strategy is to use
third-party or contract research organizations ("CROs") to assist in the conduct
of safety and efficacy testing and clinical studies, to assist the Company in
guiding products through the FDA and EMEA regulatory review and approval
processes, and to manufacture and distribute any FDA and EMEA approved products.
The Company believes that maintaining a limited infrastructure will enable it to
develop products efficiently and cost effectively.
On November 1st, 2004 the Company entered into a contract with Faustus
Forschungs Cie, Translational Cancer Research GMBH for the co development of
nine compounds targeted at various forms of Cancer.
The Company believes the use of third-parties to develop and manufacture its
products has several advantages. This approach generally allows a greater pool
of resources to be concentrated on a product than if these functions were
preformed by internal personnel who were required to support all of the
Company's product development activities. Although this approach will allow the
Company to avoid the expense associated with developing a large internal
infrastructure to support its product development efforts, it will result in the
Company being dependent on the ability of outside parties to perform critical
functions for the Company. Over time, the Company expects to build internal
capabilities to replace certain development functions now contracted to outside
parties.
This contract approach to product development requires project management by
professionals with substantial industry experience. The Company will continue to
evaluate prospective additions to its in-house expertise, as well as
opportunities for contract and advisory services in areas of critical importance
to all of its proposed products, including the management of current development
teams. These areas include regulatory affairs, marketing and sales, quality
assurance, manufacturing, clinical trials management, finance, information
systems and general management.
The product development process is designed to identify problems associated with
a proposed product's safety and effectiveness. The Company attempts to reduce
the risk that a proposed product will not be accepted in the marketplace by
conducting market research and defining commercial strategy for each product
candidate. A drug development portfolio cannot be completely insulated from
potential clinical and market failures. It is likely that some proposed products
selected for development by the Company will not produce the clinical or revenue
results expected.
-18-
Research Product Pipeline
The Company will continue to invest in the research and development of existing
and new products, including those that could extend the applications of existing
technologies. The Company is currently evaluating a number of product candidates
arising from various academic facilities and other biotech companies.
Market Overview
The pharmaceutical industry is characterized by ongoing convergence and
consolidation. Large pharmaceutical companies continue to experience depleted
product pipelines and reduced research and development ("R&D") productivity, as
measured by declining numbers of approved new chemical entities despite
year-on-year increases in R&D spending.
ONCOLOGY
Cancer is not a single disease, but a set of several hundred distinct neoplastic
entities that together represent the third largest disease burden of any
therapeutic area. According to the 2003 Facts and Figures report issued by the
American Cancer Association, men in the United States have an approximately 1 in
2 chance of developing cancer during their lifetime. The increasing age of the
population and the continuing morbidity and mortality associated with this
disease confirm the need for continued scientific research and the development
of new therapies.
o In 2004 over 10 million people were diagnosed with cancer, by 2015 this is
forecast to reach 15 million. Six million people die from cancer every
year, representing 12% of deaths worldwide.
o The National Cancer Institute estimates the overall cost of cancer in the
U.S. to be in excess of $100 billion. Treatment of breast, lung and
prostate cancers accounts for over half the direct medical costs.
o The global cancer market was valued at $34.3 billion in 2002, a 16.5%
increase on previous year's sales of $29.5 billion. Cytotoxic drugs were
the largest class, followed by hormonal therapeutics. A fast growing
category was a class that includes cytokines and monoclonal antibodies.
This class, known as the innovative therapy category, was driven by
widespread physician uptake which led to growth of over 57%.
o Oncology is currently the most active area of research for multi-national
pharmaceutical companies. BMS is currently the leading player in the
oncology market in revenue terms, with total oncology sales of $3.71
billion equating to a 10% market share.
SPECIALTY PHARMA
Specialty pharma (including `lifestyle' drugs) enhance or improve human function
in individuals who believe that their problems - from sexual dysfunction to
diabetes, incontinence and obesity - negatively affect normal aspects of
everyday living. These conditions should be capable of being defined and
diagnosed with reference to measurable characteristics, of known etiology, and
prospective patients must be capable of being targeted and convinced of the
value of pharmacotherapy.
o The appeal of Specialty drugs lies in their ability to improve physical
and mental well-being and as an alternative to making lifestyle changes.
o The ability to create new disease markets, as is currently happening in
the area of female sexual dysfunction, will cause the overall Specialty
pharma market to expand significantly over the next two decades.
o When developing and defining a new Specialty condition: (a) the disorder
must be capable of being clearly defined and diagnosed with reference to
measurable characteristics, (b) the epidemiology of the condition must be
known, and (c) prospective patients must be capable of being targeted and
convinced of the value of pharmacotherapy.
o According to definition and included conditions, the global market for
Specialty/lifestyle medicines is estimated at close to $22 billion.
Leading contributors to this total include Sexual function, ED ($2.5
billion); Smoking, alcohol ($1.5 billion); Oral contraceptives ($4.0
billion); Obesity ($1 billion); Selected dermatological conditions ($4.0
billion); Inflammatory Bowel Disease ($2.0 billion); and Fatigue ($2.0
billion).
CENTRAL NERVOUS SYSTEM
CNS (Central Nervous System) products represent a large and fast-growing sector
of the pharmaceutical market. The segment is based on neurological and
psychiatric conditions, which have been estimated to account for over 15% of the
disease burden within the world's developed economies. Conditions include
Alzheimer's Disease, Depression, Epilepsy, Migraine, Multiple Sclerosis, Pain,
Parkinson's Disease and Schizophrenia.
-19-
o The worldwide population with CNS disorders is steadily rising. This is
being driven by an aging population, improving diagnostic techniques,
increasing physician and patient awareness and a gradual shift away from
the social stigma traditionally attached to many psychiatric conditions.
o As the prevalence of CNS disorders rises, so does the cost. In the US, it
is estimated that over 20% of healthcare expenditure is directed towards
CNS related disorders. Alzheimer's disease alone is estimated to cost the
US economy $100 billion annually, with a prevalent population of over 4m.
o Neuroscience (CNS) world market value is over $98 billion, growing at 11%
per annum.
o The global CNS market is dominated by four major players, GlaxoSmithKline,
Eli Lilly, Pfizer and Janssen, who hold a combined market share of 38.8%.
CARDIOVASCULAR
The Cardiovascular market is one of the largest of all pharmaceutical sectors.
Cardiovascular disease includes heart failure, atrial fibrillation, stable
angina and peripheral arterial disease. Acute thrombotic events, including
unstable angina, myocardial infarction, deep vein thrombosis, pulmonary embolism
and stroke also contribute to the burden of disease. Risk factors including
hypercholesterolemia, hypertension, diabetes and obesity predispose the
development of cardiovascular disease in later life.
o Cardiac therapy holds enormous potential for new drugs due to high unmet
need within substantial patient populations.
o Cardiovascular world market value is currently valued at $116 billion.
Cardiovascular disease accounts for 17 million deaths globally each year.
The Statin market has a world market value of $26 billion
o Antithrombotics sales grew to just under $10 billion in 2002, with
antiplatelet therapies representing a 58% share of the class.
o Pfizer is the dominant player in the global cardiovascular market with a
19% market share.
INFECTION
Infectious diseases continue to be a leading cause of morbidity and mortality
across the globe. They are a leading cause of death, accounting for a quarter to
a third of the estimated 54 million deaths worldwide in 1998. However, new and
re-emerging infectious diseases may pose a rising global health risk. The spread
of infectious diseases can result as much from changes in human behaviour - from
lifestyles, land use patterns, increased trade and travel to inappropriate use
of antibiotic drugs - as from mutations in pathogens.
o The three main types of infections for which there is a significant market
are, in terms of Causitive Micro-organisms;
- bacterial
- fungal
- viral
In terms of the total anti-infective market, the contribution of the
anti-infective segment increased from 14% in 1996 to 22% in 2001.
o The Infection world market in 2004 was valued at $53 billion.
o There are around 30 key drugs in the Infection market. There are a number
a very large selling broad spectrum antibiotics dominating the Infection
market, such as Zithromax (Pfizer), Cipro (Bayer) and Augmentin (GSK) The
Intron franchise of Schering-Plough, which is used for the treatment of
hepatitis C infections, dominates the antiviral drugs market with a share
of around 17%. Combivir, GlaxoSmithKline's combination drug for the
treatment of HIV, is the second leading antiviral drug and has a market
share of 10%.
o The major players in the Infection market are GlaxoSmithKline,
Schering-Plough, Bristol Myers Squibb, Hoffman La Roche, Merck, Abbott
Laboratories, Pfizer, J&J and Bayer. GlaxoSmithkline is the market leader
with a share of 20%. Pfizer is the second largest player with a market
share of 10%.
GENERAL
Management's Discussion and Analysis presents a review of our consolidated
operating results and financial condition for the period ended March 31, 2005.
This discussion and analysis is intended to assist in understanding the
financial information of the Company presented elsewhere herein. This section
should be read in conjunction with our consolidated financial statements and the
related notes, as well as ITEM 1. Description of Business, of this Form 10-QSB.
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CRITICAL ACCOUNTING POLICIES
Our discussion and analysis of our financial condition and results of operations
are based upon our financial statements, which have been prepared in accordance
with accounting principles generally accepted in the United States. The
preparation of these financial statements requires us to make estimates and
judgments that affect the reported amounts of assets, liabilities, revenues and
expenses. In consultation with our Board of Directors, we have identified two
accounting principles that we believe are key to an understanding of our
financial statements. These important accounting policies require management's
most difficult, subjective judgments.
(1) GOING CONCERN
As shown in the accompanying financial statements, the Company has incurred
significant losses and needs additional capital to finance its operations. These
factors create substantial doubt about the Company's ability to continue as a
going concern. The financial statements do not include any adjustments that
might be necessary if the Company is unable to continue as a going concern. The
Company intends to finance its operations through sales of its securities as
well as entering into loans and other types of financing arrangements such as
convertible debenture. There is no assurance that the company will be successful
in its efforts.
(2) RESEARCH AND DEVELOPMENT
The Company conducts its research and development with numerous academic
research facilities, other biotechnology companies and clinical research
organizations. Such expenses are expense as incurred. Any disruption in the
Company's relationship with these entities could have a material impact on the
Company's future operations.
RESULTS OF OPERATIONS
During the three months ended March 31, 2005, work continued on the product
development programs as planned and the individual items are detailed below. The
period ended March 31, 2005, compared to the period ended March 31, 2004:
During the period the following events took place :
On 22nd February, 2005, Inncardio Inc entered into an Acquisition Agreement
effective 22nd day of February, wherein it agreed to be acquired by Softwall
Equipment Corporation whereby Softwall Equipment Corp acquired all of the
outstanding common stock of Inncardio, Inc. in exchange for 16,500,000common
shares of Softwall. After the issuance of the 16,500,000 shares in the
Acquisition, the company had approximately 18,010,000 shares of its common stock
issued and outstanding and changed its name to Inncardio, Inc .
On March 9, 2005, Bioacelerate Holdings Inc provided Inncardio, Inc with a
secured credit facility of $12.0 million which bears interest at 3.625%.
On March 16, 2005, the Company assigned, subject to written consent of the other
parties, seven agreements for drug development and licensing and sold Cynat
Oncology, Inc to Innovate Oncology, Inc pursuant to an agreement for the Company
to grant rights to six clinical and up to four pre-clinical compounds to
Innovate from its drug portfolio.
On March 24, 2005, Inncardio Inc entered into an Agreement and Plan of Merger
(the "Agreement and Plan of Merger") among Inncardio Inc, Cengent Acquisition
Corp. ("CAC"), a wholly-owned subsidiary of Inncardio Inc, and Cengent
Therapeutics Inc. ("Cengent"), a privately held company. Pursuant to the Merger
Agreement, CAC will merge with and into Cengent, and as a consequence of the
merger (the "Merger") Cengent will become a wholly owned subsidiary of the
Registrant. The Merger is expected to be consummated in the Fall of 2005
No significant revenues were generated in the period
General and administrative expenses increased from $468,306 in the quarter ended
May 31, 2004, to $3,021,774 in quarter to March 31, 2005. The main reason for
the increase was the significant development of the Company's infrastructure to
support its planned growth. Such costs were primarily wages and consulting fees.
Research & Development expenses for the quarter ended March 31, 2005, were
$3,628,363 as compared with $nil in the previous year. The majority of these
expenses were in connection with the development of an increased number of our
product candidates and to a charge of $1.35 million for research and development
at Enhance Biotech and Cengent Technologies.
Non cash stock compensation was $18,167,581 for the quarter ended March 31, 2005
compared with nil for the same period in the previous year. These amounts were
due to payments made for services and satisfaction of debt arrisi ng from the
acquisition of Pharma Manufacturing services Ltd by the issue of shares at
market prices.
A further provision for impairment of $500,000 was made for the period to March
31, 2005 , no provision was made in the same period in the previous year.
The Company has incurred substantial trading losses to date and has an
accumulated deficit of $185,504,744 as at March 31, 2005.
Liquidity & Capital Resources
Since our inception, we have financed our operation through the sale of stock
and the issuance of debt. The Company has a $32,500,000 line of credit facility
as of March 31, 2005. $9,719,602 of the line is outstanding. The facility
accrues interest at the Applicable Federal Rate, as defined in Section 1247(d)
of the Internal Revenue Code. As of March 31, 2005, the interest rate was 4.0%.
In February 2004, Bioaccelerate, Inc sold 5,100,000 shares of common stock at
$1.00 per share and received net proceeds of $4,816,781 after expenses. At March
31, 2005 cash and cash equivalents totalled approximately $791,618. The Company
expects to incur substantial additional research and development expenses and
general administrative expenses, including personal-related costs, cost related
to preclinical testing and clinical trials. The Company intends to seek
additional funding through the sale of debt and equity securities, increases in
our credit facilities and with suitable potential collaborators
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Item 3. Controls and Procedures.
The issuer's principal executive officer or officers and principal financial
officer or officers, or persons performing similar functions, are responsible
for establishing and maintaining disclosure controls and procedures (as defined
in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over
financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d- 15(f))
for the issuer and have:
designed such disclosure controls and procedures, or caused such disclosure
controls and procedures to be designed under their supervision, to ensure that
material information relating to the issuer, including its consolidated
subsidiaries, is made known to them by others within those entities,
particularly during the period in which the periodic reports are being prepared;
designed such internal control over financial reporting, or caused such internal
control over financial reporting to be designed under their supervision, to
provide reasonable assurance regarding the reliability of financial reporting
and the preparation of financial statements for external purposes in accordance
with generally accepted accounting principles;
evaluated the effectiveness of the issuer's disclosure controls and procedures
as of the end of the fiscal quarter (the "Evaluation Date").
Based on their evaluation as of the Evaluation Date, their conclusions about the
effectiveness of the disclosure controls and procedures were that nothing
indicated:
any significant deficiencies in the design or operation of internal controls
which could adversely affect the issuer's ability to record, process, summarize
and report financial data;
any fraud, whether or not material, that involves management or other employees
who have a significant role in the issuer's internal controls; or
any material weaknesses in internal controls that have been or should be
identified for the issuer's auditors and disclosed to the issuer's auditors and
the audit committee of the board of directors (or persons fulfilling the
equivalent function).
Changes in internal control over financial reporting. There was no significant
change in the issuer's internal control over financial reporting that occurred
during the most recent fiscal quarter that has materially affected, or is
reasonably likely to materially affect, the issuer's internal control over
financial reporting.
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PART II - OTHER INFORMATION
Item 1. Legal Proceedings
The Company is not a party to any material pending legal proceedings. No such
action is contemplated by the Company nor, to the best of its knowledge, has any
action been threatened against the Company.
Item 2. Sales of Unregistered Equity Securities and Use of Proceeds
(a) There were no sales of unregistered securities in the period
(b) During the period covered by this report, there were no securities that the
issuer sold by registering the securities under the Securities Act.
(c) During the period covered by this report, there was no repurchase made of
equity securities registered pursuant to section 12 of the Exchange Act. None of
the issuer's securities is registered pursuant to section 12 of the Exchange Act
Item 3. Defaults upon Senior Securities
None
Item 4. Submission of matters to a vote of Security holders
None
Item 5. Other Information - Changes in Registrant's Certifying Accountant.
As of April 29, 2005, the Registrant has appointed new auditors. Registrant
terminated F E Hanson Limited as the company's auditor. The decision to change
auditors was approved by the Board of Directors. The former accountant only
acted for the Registrant from November 2004. The prior accountant did not render
any report on the financial statements for the past two years which contained
any adverse opinion or disclaimer of opinion, or was qualified or modified as to
uncertainty, audit scope or accounting principles. During the Registrant's two
most recent fiscal years and any subsequent interim period preceding the
termination there were no disagreements with the former accountant on any matter
of accounting principles or practices, financial statement disclosure, or
auditing scope or procedure.
Simultaneously with the termination of its relationship with F E Hanson
Limited., Registrant retained Stark, Winter, Schenkein, & Co., LLP, as
registrant's independent auditors. Stark, Winter, Schenkein, & Co LLP's address
is 7535 East Hampden Avenue, Suite 109, Denver, CO, 80231
Item 6. Exhibits and Reports Filed on Form 8-K.
The registrant filed a Form 8-K on 4th May, 2005 reporting that it had
terminated FE Hanson Limited as the company's auditors and appointed Stark,
Winter, Schenkein & Co, LLP as the company's auditor. This form 8-K is hereby
incorporated by reference.
Exhibit Index - Exhibits required by Item 601 of Regulation S-B.
(31) Certifications required by Rules 13a-14(a) or 15d-14(a).
(32) Section 1350 Certifications
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SIGNATURES
In accordance with the requirements of the Exchange Act, the registrant caused
this report to be signed on its behalf by the undersigned, thereunto duly
authorized.
Bioaccelerate Holdings, Inc.
Date: September 16, 2005 By: /s/ Lee Cole
--------------------------------------------
Lee Cole, CEO, President and Director
Date: September 16, 2005 By: /s/ Linden Boyne
--------------------------------------------
Linden Boyne, CFO, Secretary-Treasurer
& Director
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