UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-QSB
(Mark One)
(X) QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
For the quarterly period ended: June 30, 2003
( ) TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
For the transition period from __________ to __________
Commission File Number: 33-63474
CALLISTO PHARMACEUTICALS, INC.
------------------------------
(Exact name of Registrant as specified in its charter)
Delaware 13-3894575
------------------------------- -------------------
(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification No.)
420 Lexington Avenue, Suite 601, New York, New York 10710
--------------------------------------------------- -----
(Address of principal executive offices) (Zip Code)
(212) 672-9190
--------------
(Registrant's telephone number)
Webtronics, Inc.
420 Lexington Avenue, Suite 601
New York, New York 10710
------------------------
(Former Name, Former Address and Former Fiscal Year, if changed since
last report)
APPLICABLE ONLY TO CORPORATE ISSUERS:
State the number of shares outstanding of each of the issuer's classes of common
equity, as of the latest practicable date:
Class Outstanding at August 15, 2003
------------------------------- ------------------------------
Common Stock, par value $0.0001 23,204,851 shares
Transitional Small Business Disclosure Format (check one): Yes |_| No |_|
INTRODUCTORY NOTE
This report on Form 10QSB may contain forward looking statements. You can
identify these statements by forward-looking words such as "may," "will,"
"expect," "intend," "anticipate," "believe," "estimate" and "continue" or
similar words. Forward-looking statements include information concerning
possible or assumed future business success or financial results. You should
read statements that contain these words carefully because they discuss future
expectations and plans, which contain projections of future results of
operations or financial condition or state other forward-looking information. We
believe that it is important to communicate future expectations to investors.
However, there may be events in the future that we are not able to accurately
predict or control. Accordingly, we do not undertake any obligation to update
any forward-looking statements for any reason, even if new information becomes
available or other events occur in the future.
The forward-looking statements included herein are based on current expectations
that involve a number of risks and uncertainties set forth under "Risk Factors"
in our Report on Form 8-K and other periodic reports filed with the SEC.
Accordingly, to the extent that this Report contains forward-looking statements
regarding the acquisitions, financial condition, operating results, business
prospects or any other aspect of the Company, please be advised that the
Company's actual financial condition, operating results and business performance
may differ materially from that projected or estimated by the Company in
forward-looking statements.
2
PART I - FINANCIAL INFORMATION
Item 1. Financial Statements
CALLISTO PHARMACEUTICALS, INC.
(A Development Stage Company)
CONSOLIDATED BALANCE SHEET as of JUNE 30, 2003
(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents $ 1,269,257
Prepaid insurance ($146,614) and other current assets 219,650
------------
1,488,907
------------
Fixed assets, net of accumulated
depreciation of $18,244 66,393
------------
Other assets:
Rent deposit 44,746
------------
44,746
------------
$ 1,600,046
============
LIABILITIES AND SHAREHOLDERS' EQUITY
Accounts payable, accruals and other current liabilities $ 810,650
------------
Shareholders' equity:
Common stock $.0001 par value, 60,000,000 authorized
shares and issued and outstanding
23,217,578 2,319
Additional paid-in-capital 20,483,066
Accumulated deficit during the development stage (19,695,989)
------------
789,396
------------
$ 1,600,046
============
The accompanying notes are an integral part of these financial statements
3
CALLISTO PHAMACEUTICALS, INC.
(A Development Stage Company)
CONSOLIDATED STATEMENT OF OPERATIONS
(Unaudited)
Six Months Ended Three Months Ended June 5, 1996
June 30, June 30, (Inception) to
2003 2002 2003 2002 June 30, 2003
------------ ------------ ------------ ------------ ------------
Revenues $ - $ - $ - $ - $ -
------------ ------------ ------------ ------------ ------------
Costs and expenses:
Research and development 354,912 221,604 323,612 115,735 6,075,936
Purchased in process
Research and Development 6,833,454 - 6,833,454 - 6,833,454
General and administrative 444,260 295,754 310,630 159,408 2,247,974
Stock based compensation 2,450,948 327,884 1,307,214 163,942 4,536,059
Interest expense 336 - 336 - 2,566
------------ ------------ ------------ ------------ ------------
Net loss $(10,083,910) $ (845,242) $ (8,775,246) $ (439,085) $(19,965,989)
------------ ============ ============ ============ ============
Weighted average shares outstanding:
basic and diluted 19,306,915 17,318,944 21,272,990 17, 318,944 -
Net loss per common share:
basic and diluted ($0.52) ($0.05) ($0.41) ($0.02) -
The accompanying notes are an integral part of these financial statements
4
CALLISTO PHARMACEUTICALS, INC.
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
For the Six For the Six June 5, 1996
Months Ended Months Ended (Inception) to
June 30, 2003 June 30, 2002 June 30, 2003
------------- ------------- -------------
Cash flows from operating activities:
Net loss $(10,083,910) $ (845,242) $(19,965,989)
Adjustments to reconcile net loss to
Net cash used in operating activities:
Purchased in process research and development 6,833,454 - 6,833,454
Stock based compensation 2,450,948 327,884 4,536,059
Depreciation and amortization 7,810 6,027 18,204
Unrealized loss on investment - - 30,986
Common and preferred stock issued for services - - 91,667
Cancellation in note receivable - - 91,770
Increase in note receivable - - (91,770)
Changes in operating assets and liabilities
Increase in prepaid insurance
and other current assets (181,853) (24,533) (219,650)
Increase in accounts payable, accruals and other liabilities 29,052 41,543 979,244
------------ ------------ ------------
Total adjustments 9,139,411 350,921 12,269,964
------------ ------------ ------------
Net cash used in operating activities (944,499) (494,321) (7,696,025)
------------ ------------ ------------
Cash flows from investing activities:
Acquisition of furniture & equipment (54,452) (11,485) (84,627)
Investment in Webtronics, Inc. - (400,000) (400,000)
Rent deposit 44,746 - 44,746
Proceeds (loss) on sale of marketable securities - - (30,986)
------------ ------------ ------------
Net cash (used in) provided by investing activities (9,706) (411,485) (470,867)
------------ ------------ ------------
Cash flows from financing activities:
Issuance of common and preferred stock (net of repurchases) - - 9,436,149
------------ ------------ ------------
Net cash (used in) provided by investing activities - - 9,436,149
------------ ------------ ------------
Net (decrease) increase in cash and cash equivalents (954,205) (905,806) 1,269,257
Cash and cash equivalent at beginning of period 2,223,462 3,627,479 -
------------ ------------ ------------
Cash and cash equivalent at end of period $ 1,269,257 $ 2,721,673 $ 1,269,257
============ ============ ============
Supplementary disclosures of cash flows information:
Cash paid for taxes $ 28,858 $ - $ 48,152
============ ============ ============
The accompanying notes are an integral part of these financial statements
5
NOTES TO JUNE 30, 2003 FINANCIAL STATEMENTS (UNAUDITED)
1. Basis of presentation:
The accompanying unaudited consolidated financial statements of Callisto
Pharmaceuticals, Inc. ("Callisto"a development stage company), and its
subsidiaries have been prepared in accordance with generally accepted accounting
principles for interim financial information and the rules of the Securities and
Exchange Commission (the "SEC") for quarterly reports on Form 10-QSB and do not
include all of the information and footnote disclosures required by generally
accepted accounting principles for complete financial statements. These
statements should be read in conjunction with Callisto's audited financial
statements and notes thereto for the year ended December 31, 2002, included in
the 2003 Form 8K.
In the opinion of management, the accompanying unaudited consolidated financial
statements include all adjustments, primarily consisting of normal adjustments,
necessary for the fair presentation of the balance sheet and results of
operations for the interim periods. The results of operations for the three and
six months ended June 30, 2003 are not necessarily indicative of the results of
operations to be expected for the full year ending December 31, 2003.
The accompanying unaudited consolidated financial statements have been prepared
assuming that Callisto will continue as a going concern. Management believes
that current resources will be sufficient to support its planned operations
though the fourth quarter 2003. Callisto does not have commercial
biopharmaceutical products, and does not expect to have such for several years,
if at all. In addition, Callisto merged with Synergy Pharmaceuticals Inc.
("Synergy") in April 2003, which will require additional cash to integrate the
combined companies. Callisto believes that it will need additional funds to
complete the development of its biomedical products. These circumstances raise
substantial doubt about Callisto's ability to continue as a going concern beyond
December 31, 2003. Management's plans with regard to these matters include
continued development of its products as well as seeking additional research
support funds and financial arrangements. Although management continues to
pursue these plans, there is no assurance that Callisto will be successful in
obtaining sufficient financing on terms acceptable to Callisto. In the event
that the Callisto is unable to raise additional funds, planned operations will
need to be scaled back or discontinued. The financial statements do not include
any adjustments that might result from the outcome of these uncertainties.
2. Significant Accounting Policies
Business Combinations
The Company accounts for business combinations in accordance with the provisions
of Statement of Financial Accounting Standards No. 141 "Business Combinations"
("SFAS 141"). SFAS 141 requires business combinations completed after June 30,
2001 to be accounted for using the purchase method of accounting. It also
specifies the types of acquired intangible assets required to be recognized and
reported separately from goodwill.
Long-lived assets
The Company accounts for long-lived assets such as non-compete agreements and
research contracts in accordance with the provisions of Statement of Financial
Accounting Standards No. 144 "Accounting for the Impairment or Disposal of
Long-Lived Assets" ("SFAS 144"). SFAS 144 requires that long-lived assets be
reviewed for impairment whenever events or changes in circumstances indicate
that the carrying amount of the asset may not be recoverable. The Company
compares the carrying amount of the asset to the estimated undiscounted future
cash flows expected to result from the use of the asset. If the carrying amount
of the asset exceeds estimated expected undiscounted future cash flows, the
Company records an impairment charge for the difference between the carrying
amount of the asset and its fair value. Changes in events or circumstances
impacting long-lived assets include, but are not limited to, cancellations or
terminations of research contracts or pending government research grants.
Income taxes
Income taxes are accounted for under the asset and liability method prescribed
by Statement of Financial Accounting Standards No. 109, "Accounting for Income
Taxes." Deferred income taxes are recorded for temporary differences between
financial statement carrying amounts and the tax basis of assets and
liabilities. Deferred tax assets and liabilities reflect the tax rates expected
to be in effect for the years in which the differences are expected to reverse.
A valuation allowance is provided if it is more likely than not that some or all
of the deferred tax asset will not be realized.
Accounting for stock based compensation
The Company has adopted Statement of Financial Accounting Standard No. 123,
"Accounting for Stock-Based Compensation" ("SFAS 123"). As provided for by SFAS
123, the Company has elected to continue to account for its stock-based
compensation programs according to the provisions of Accounting Principles Board
Opinion No. 25, "Accounting for Stock Issued to Employees ("APB 25")."
Accordingly, compensation expense has been recognized to the extent of employee
or director services rendered based on the intrinsic value of compensatory
options or shares granted under the plans. The Company has adopted the
disclosure provisions required by SFAS 123, as amended by SFAS 148, "Accounting
for Stock-Based Compensation - Transaction and Disclosure, an amendment to FASB
Statement No. 123."
Had compensation cost for stock options granted been determined based upon the
fair value at the grant date for awards, consistent with the methodology
prescribed under SFAS 123, the Company's net loss and net loss per share would
have been as follows:
Six Months Ended Three Months Ended
June 30, June 30,
2003 2002 2003 2002
--------------------------------- ----------------------------
Net loss, as reported ($10,083,910) ($845,242) ($8,775,246) ($439,085)
================================= ===========================
Add: Stock-based non-employee
compensation expense recorded
under APB No. 25 2,450,948 327,884 1,307,214 163,942
Deduct: Total stock-based compensation
expense determined under fair value
based method for all awards (3,575,628) (339,875) (2,425,898) (169,937)
--------------------------------- ---------------------------
Pro forma net loss ($11,208,590) ($857,233) ($9,893,930) ($445,080)
================================= ===========================
Net loss per share:
Basic and diluted -as reported ($0.52) ($0.05) ($0.41) ($0.02)
================================= ===========================
Basic and diluted -pro forma ($0.58) ($0.05) ($0.47) ($0.02)
================================= ===========================
The fair value of the options granted to employees during 2003 and 2002 ranged
from $2.50 to $5.80 on the date of the respective grant using the Black-Scholes
option-pricing model. The following weighted average assumptions were used for
2003 and 2002: no dividend yield, expected volatility of 100%, risk free
interest rates of 2.87%-4.50% and an expected term of 7 to 10 years.
2. Merger and consolidation:
On April 30, 2003 Webtronics, Inc. entered into a merger agreement with Callisto
Research Labs, LLC (formerly known as Callisto Pharmaceuticals, Inc.) and
Synergy Pharmaceuticals Inc.,("Synergy") an unaffiliated company also in the
development stage, under which agreement Callisto Research and Synergy agreed to
merge in a stock for stock transaction and each become subsidiaries of
Webtronics, Inc. Webtronics subsequently changed its name to Callisto
Pharmaceuticals, Inc. Pursuant to the merger agreement 17,318,994 shares of
Webtronics common stock were issued to holders of Callisto Research common stock
and 4,395,684 shares to holders of Synergy common stock in exchange for
outstanding Callisto Research and Synergy common stock. As a result of the
merger there were a total of 23,217,578 Webtronics shares outstanding.
The 4,395,684 shares issued to the former shareholders of Synergy were valued at
$6,593,526. The purchase price in excess of the tangible net worth acquired was
allocated in full to the Synergy research and development projects which had not
yet reached technological possibility and had no altenative use. The merged
companies are considered to be in the development stage. No revenues have been
realized and all activities have been concentrated in research and development
of biopharmaceutical products yet to be approved by the Food and Drug
Administration.
Net assumed liabilities in excess of Synergy assets acquired in the merger at
April 30, 2003 were as follows:
Cash $ 9,501
Accounts receivable 258,928
Rent deposit 44,746
Fixed assets 38,343
--------
Total assets acquired 351,518
Accounts payable and other liabilities assumed 591,446
-------
Net liabilities assumed in excess of assets acquired $239,928
========
In addition purchased in-process research and development cost totaled
$6,593,526 were charged to expense during the quarter ended June 30, 2003. The
results of operations of Synergy for the period May 1, 2003 through June 30,
2003 are included in the consolidated statement of operations for the quarter
and six months ended June 30, 2003, as well as the consolidated balance sheet as
of June 30, 2003.
3. Cash and cash equivalents:
For purposes of the statements of cash flows, the Company considers all highly
liquid debt instruments with an original maturity of three months or less to be
cash equivalents.
4. Proforma results of operations:
The following (unaudited) combined proforma results of operations for the six
months ended June 30, 2003 and 2002 have been prepared as if the merger of the
companies had occurred at January 1, 2003, and 2002
2003 2002
---- ----
Revenues $ $
Net loss (10,261,075) (1, 494,486)
Net loss per common share
(23,217,578 common shares) (.44) (.06)
5. Research and development:
The Company is engaged in various pharmaceutical patent and research and
development projects under arrangements with various research facilities and
universities whereby certain minimum annual fees and royalty payments are
required to be paid. Research and development expense included in these
financial statements are all expenditures made to research facilities and
universities.
6. Stock option plan:
In 1996, the Company adopted an incentive and non-qualified stock option plan
(the"Plan") for employees, consultants and outside directors to purchase up to
2,000,000 shares of common stock. The Plan was amended in December 2002 to
increase the number of shares authorized under the Plan to 10,000,000. The
option term for options granted under the Plan is ten years from date of grant..
The following represent options outstanding for the six months ended June 30,
2003 and for the years ended December 31, 2002 and 2001 generally to
non-employees:
Total
----------
Balance, January 1, 2001 1,931,505
Year 2001:
Granted 400,000
Exercised -
----------
Balance, December 31, 2001 2,331,505
Year 2002:
Granted 330,000
Cancelled
Exercised -
----------
Balance, December 31, 2002 2,661,505
Six month ended June 30, 2003:
Granted 3,286,055
Exercised -
Cancelled (917,333)
----------
Balance, June 30, 2003 5,030,227
==========
Options are exercisable at various prices as follows at June 30, 2003:
Exercise
Price Total
--------- ---------
$0.75 615,839
1.10 500,000
1.25 400,000
1.30 383,055
1.50 1,523,000
1.75 27,500
1.95 266,667
2.25 90,000
2.85 262,500
4.90 125,000
6.75 36,666
2.50 800,000 (A)
-------------
5,030,227
=============
(A) Vesting subject to achievement of certain future drug development
milestones.
8. Income taxes:
The Company has available net operating tax loss carryforwards of approximately
$7,000,000 through June 30, 2003 to offset future taxable income. The net
deferred asset has been fully offset by a valuation allowance due to
uncertainties regarding realization of benefits from future tax deductions
9. Earnings per share:
The assumed exercise of options has not been used in the calculation of earnings
per share as their use would be anti-dilutive.
10. Employment Contracts
On June 13, 2003, the Company entered into employment agreements with Gary S.
Jacob, Ph.D., our Chief Executive Officer and Chief Scientific Officer and
Kunwar Shailubhai, Ph.D., our Executive Vice President and Head of Research and
Development. Each of their employment agreements is for a term of 18 months
beginning June 13, 2003 and is automatically renewable for successive one year
periods at the end of the term. Dr. Jacob's salary is $225,000 per year and he
is eligible to receive a cash bonus of up to 15% of his salary per year. Dr.
Jacob received a grant of 500,000 stock options which vest over a three year
period and are exercisable at $1.50 per share.. Dr. Shailubhai's salary is
$170,000 per year and he is eligible to receive a cash bonus of up to 15% of his
salary per year. Dr. Shailubhai received a grant of 25,000 stock options which
are fully vested and have an exercise price of $1.50 per share. Dr. Shailubhai
also received a grant of 325,000 stock options which vest over a three year
period and are exercisable at $1.50 per share.
ITEM 2. Management's Discussion and Analysis of Financial Condition and Results
of Operations
The following discussion should be read in conjunction with our financial
statements and notes to those statements and other financial information
appearing elsewhere in this Quarterly Report. In addition to historical
information, the following discussion and other parts of this Quarterly Report
contain forward-looking information that involves risks and uncertainties.
Overview
We are a development stage biopharmaceutical company, whose primary focus is on
biopharmaceutical product development. Since inception in June 1996 our efforts
have been principally devoted to research and development, securing patent
protection, obtaining corporate relationships and raising capital. Since
inception through June 30, 2003, we have sustained cumulative net losses of
$19,965,989. Our losses have resulted primarily from expenditures incurred in
connection with the purchase of in-process research and development, stock
compensation expenses, patent filing and maintenance, outside accounting and
legal services and regulatory consulting fees.
From inception through June 30, 2003 we have not generated any revenue from
operations. We expect to incur additional losses to perform further research and
development activities. We do not currently have any commercial
biopharmaceutical products, and do not expect to have such for several years, if
at all. Our lead drug candidate, Atiprimod, is a small molecule, orally
available drug, with antiprolifererative and antiangiogenic activity. Atiprimod
successfully completed Phase I clinical trials in rheumatoid arthritis patients
and we plan to enter Atiprimod in a safety and proof of principle clinical trial
in multiple myeloma patients. The IND application (Investigative New Drug) for
Phase I of these clinical trials is planned to be filed with the FDA during the
third quarter of 2003.
Our product development efforts are thus in their early stages and we cannot
make estimates of the costs or the time it will take to complete. The risk of
completion of any program is high because of the long duration of clinical
testing, extended regulatory approval and review cycles and uncertainty of the
costs. Net cash inflows from any products developed make take several years to
achieve. We could however receive grants, contracts or technology licenses in
the short-term. The amount and timing of these inflows, if any, is not known. We
are also in the process of raising additional capital through a private
placement of common stock which began in July 2003. There can be no assurance we
will be successful in these fund raising efforts.
The accompanying financial statements have been prepared assuming that we will
continue as a going concern. We believe that current resources will be
sufficient to support planned operations through the fourth quarter 2003. These
circumstances raise substantial doubt about our ability to continue as a going
concern. Our plan is to continue product development beyond December 31, 2003
and seek additional research support and investment capital. There is no
assurance that we will be successful in obtaining sufficient financing on terms
acceptable to us. In the event that we are unable to raise additional funds,
planned operations will need to be scaled back or discontinued. The financial
statements do not include any adjustments that might result from the outcome of
this uncertainty.
On April 30, 2003, pursuant to an Agreement and Plan of Merger dated March 10,
2003, as amended April 4, 2003 , Synergy Acquisition Corp., our wholly-owned
subsidiary, merged into Synergy Pharmaceuticals Inc. and Callisto
Pharmaceuticals, Inc., our wholly-owned subsidiary, merged into the predecessor
of Callisto Research Labs, LLC. As a result of the merger Callisto Research and
Synergy are our wholly owned subsidiaries. We issued 17,318,994 shares of our
common stock in exchange for all outstanding Callisto Research, LLC common stock
and an additional 4,395,684 shares in exchange for outstanding Synergy common
stock.
Significant Accounting Policies
Financial Reporting Release No. 60 requires all companies to include a
discussion of critical accounting policies or methods used in the preparation of
financial statements. Note 1 of the notes to our financial statements include a
summary of the significant accounting policies and methods used in the
preparation of our financial statements.
Results of Operations
Three Months ended June 30, 2003 and June 30, 2002.
We had no revenues during the three months ended June 30, 2003 and 2002 because
we do not have any commercial biopharmaceutical products, and we do not expect
to have such product for several years, if at all.
Research and development expenses increased approximately 180% to $323,612 for
the three months ended June 30, 2003 from $115,735 for the same period in 2002.
The increase was primarily the result of the Synergy merger discussed elsewhere
in this report. The results of operations of Synergy for the period May 1, 2003
through June 30, 2003 are included in the consolidated statement of operations
for the quarter ended June 30, 2003, as well as the consolidated balance sheet
as of June 30, 2003. The increase in research and development expense was
primarily attributable to higher payroll as we retained two key Synergy
executive staff scientists subsequent to the Synergy merger. Travel expenses
also increased in the period as a result of travel associated with administering
and managing the contractors and vendors involved in preparing the IND
(Investigational New Drug) application for Atiprimod.
In addition we purchased in-process research and development cost as a result of
the Synergy merger valued at $6,833,454. This cost (non-cash) was charged to
expense during the quarter ended June 30, 2003 and there was no such cost during
the quarter ended June 30, 2002. All of our product programs are in the early
stage of development and we can not make estimates of the potential cost for any
program to be completed or the time it will take to complete the project.
General and administrative expenses for the three months ended June 30, 2003
were $310,630, an increase of approximately 95% from $159,408 for the three
months ended June 30, 2002. The increase was primarily due to higher legal,
accounting and professional fees related to various regulatory filings related
to the Synergy merger. In addition facilities and related office overhead
increased as we assumed the short term lease obligation of Synergy on its New
Jersey operations. It is anticipated that Synergy operations will be
consolidated into our expanded New York City office during the third quarter
2003 with no material savings or increase in total facilities cost, however a
rent deposit of $44,746 was incurred and capitalized during the three months
ended June 30, 2003 to secure the additional space.
Net loss for the three months ended June 30, 2003 was $8,775,246 compared to a
net loss of $439,085 incurred for the three months ended June 30, 2002. The
increase in the net loss is the result of higher operating expenses as presented
in more detail above, plus $1,307,214 of stock based compensation expense,
recorded under APB25, attributable to the grant of stock options to
non-employees for services rendered during the quarter ended June 30, 2003.
Stock compensation expense attributable to grants awarded during the quarter
ended June 30, 2002 totaled $163,942.
Six Months ended June 30, 2003 and June 30, 2002.
We had no revenues during the six months ended June 30, 2003 and 2002 because we
do not have any commercial biopharmaceutical products, and we do not expect to
have such product for several years, if at all.
Research and development expenses increased approximately 60% to $354,912 for
the six months ended June 30, 2003 from $221,604 for the same period in 2002.
The increase was primarily the result of the Synergy merger discussed elsewhere
in this report. The results of operations of Synergy for the period May 1, 2003
through June 30, 2003 are included in the consolidated statement of operations
for the six months ended June 30, 2003, as well as the consolidated balance
sheet as of June 30, 2003. The increase in research and development expense was
primarily attributable to higher payroll as we retained two key Synergy
executive staff scientists subsequent to the Synergy merger. Travel expenses
also increased in the period as a result of travel associated with administering
and managing the contractors and vendors involved in preparing the IND
(Investigational New Drug) application for Atiprimod.
In addition we purchased in-process research and development cost as a result of
the Synergy merger valued at $6,833,454. This cost was charged to expense during
the six months ended June 30, 2003 and there was no such cost during the same
period ended June 30, 2002. All of our product programs are in the early stage
of development and we can not make estimates of the potential cost for any
program to be completed or the time it will take to complete the project.
General and administrative expenses for the six months ended June 30, 2003 were
$444,260, an increase of approximately 50% from $295,754 for the six months
ended June 30, 2002. The increase was primarily due to higher legal, accounting
and professional fees related to various regulatory filings related to the
Synergy merger. In addition facilities and related office overhead increased as
we assumed the short term lease obligation of Synergy on its New Jersey
operations. It is anticipated that Synergy operations will be consolidated into
our expanded New York City office during the third quarter 2003 with no material
savings or increase in total facilities cost. A rent deposit of $44,746 was
incurred and capitalized during the six months ended June 30, 2003 to secure the
additional space.
Net loss for the six months ended June 30, 2003 was $10,083,910 compared to a
net loss of $845,242 incurred for the six months ended June 30, 2002. The
increase in the net loss is the result of higher operating expenses as presented
in more detail above, plus $2,450,948 of stock based compensation expense,
recorded under APB25, attributable to the grant of stock options to
non-employees for services rendered during the six months ended June 30, 2003.
$327,884 of stock compensation expense was recorded for option grants awarded
during the same period ended June 30, 2002.
Liquidity and Capital Resources
As of June 30, 2003 we had $1,269,257 in cash and cash equivalents, compared to
$2,223,462 as of December 31, 2002. This decrease in cash of $954,205 during the
six months ended June 30, 2003 was principally the result of $944,499 used in
operating activities Our working capital as of June 30, 2003 totaled $678,257 as
compared to $1,808,652 as of December 31, 2002. This decrease of $1,130,395 was
primarily due to the cash used in operating activities, plus the assumption of
the net liabilities of Synergy as a result of the merger discussed elsewhere in
this report.
Our working capital requirements will depend upon numerous factors including but
not limited to the nature, cost and timing of: pharmaceutical research and
development programs; pre-clinical and clinical testing; obtaining regulatory
approvals; technological advances and our ability to establish collaborative
arrangements with research organizations and individuals needed to commercialize
our products
Our capital resources will be focused primarily on the clinical development and
regulatory approval of Atiprimod for multiple myeloma and bone resorption
disease, a major complication associated with multiple myeloma disease. We plan
to enter Atiprimod in a safety and proof of principle clinical trial in multiple
myeloma patients. The IND (Investigative New Drug) application for Phase I of
these trials is planned to be filed with the FDA during the third quarter of
2003.
On August 28, 2002, our wholly-owned subsidiary, Synergy Pharmaceuticals Inc.
entered into a license agreement with AnorMED Inc. to license Atiprimod from
AnorMED. The license agreement provides for milestone payments and royalties on
net sales. Commencing on January 1, 2004 and on January 1 of each subsequent
year we are obligated to pay AnorMED a maintenance fee of $200,000.
Our product development efforts are thus in their early stages and we cannot
make estimates of the costs or the time it will take to complete. The risk of
completion of any program is high because of the long duration of clinical
testing, extended regulatory approval and review cycles and uncertainty of the
costs. Net cash inflows from any products developed make take several years to
achieve. We could however receive grants, contracts or technology licenses in
the short-term. The amount and timing of these inflows, if any, is not known.
We are also in the process of raising additional capital through a private
placement of common stock which began in July 2003. There can be no assurance we
will be successful in these fund raising efforts.
Recent Developments
In addition to the merger described in Part II, Item 2 of this Report, on May
20, 2003, we effected a name change from Webtronics, Inc. to Callisto
Pharmaceuticals, Inc. and we changed our corporate domicile from Florida to
Delaware.
On June 13, 2003, we entered into employment agreements with Gary S. Jacob,
Ph.D., our Chief Executive Officer and Chief Scientific Officer and Kunwar
Shailubhai, Ph.D., our Executive Vice President and Head of Research and
Development. Each of their employment agreements is for a term of 18 months
beginning June 13, 2003 and is automatically renewable for successive one year
periods at the end of the term. Dr. Jacob's salary is $225,000 per year and he
is eligible to receive a cash bonus of up to 15% of his salary per year. Dr.
Jacob received a grant of 500,000 stock options which vest over a three year
period and are exercisable at $1.50 per share.. Dr. Shailubhai's salary is
$170,000 per year and he is eligible to receive a cash bonus of up to 15% of his
salary per year. Dr. Shailubhai received a grant of 25,000 stock options which
are fully vested and have an exercise price of $1.50 per share. Dr. Shailubhai
also received a grant of 325,000 stock options which vest over a three year
period and are exercisable at $1.50 per share.
ITEM 3. Controls and Procedures
Our Chief Executive Officer and Principal Financial Officer, based on the
evaluation of our disclosure controls and procedures (as defined in Rules
13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934, as amended)
required by paragraph (b) of Rule 13a-15 or Rule 15d-15, as of the end of the
period covered by this report, have concluded that our disclosure controls and
procedures were effective to ensure the timely collection, evaluation and
disclosure of information relating to our company that would potentially be
subject to disclosure under the Securities Exchange Act of 1934, as amended, and
the rules and regulations promulgated there under.
During the three months ended June 30, 2003, there were no changes in our
internal control over financial reporting identified in connection with the
evaluation required by paragraph (d) of the Rule 13a-15 or Rule 15d-15 that has
materially affected, or is reasonably likely to materially affect, the internal
control over financial reporting.
PART II. OTHER INFORMATION
Item 2. Changes in Securities and Legal Proceedings.
(c) On April 30, 2003, pursuant to an Agreement and Plan of Merger
dated March 10, 2003, as amended April 4, 2003, Synergy Acquisition Corp., our
wholly-owned subsidiary merged into Synergy Pharmaceuticals Inc. and Callisto
Acquisition Corp., our wholly-owned subsidiary merged into the corporate
predecessor of Callisto Research Labs, LLC (the "Merger"). As a result of the
Merger, Callisto Research Labs, LLC and Synergy Pharmaceuticals Inc. are
wholly-owned subsidiaries of our company. In the Merger we issued 17,318,994
shares of our common stock in exchange for outstanding Callisto Research Labs,
LLC common stock and an additional 4,395,684 shares in exchange for outstanding
Synergy Pharmaceuticals Inc. common stock. The issuance of shares was done in
accordance with Regulation D under the Securities Act of 1933, as amended. In
connection therewith, a filing on Form D with the Securities and Exchange
Commission was made on May 15, 2003.
Item 6. Exhibits and Reports on Form 8-K
(a) Exhibits
10.1 Employment Agreement dated June 13, 2003 by and between Callisto
Pharmaceuticals, Inc. and Gary S. Jacob
10.2 Employment Agreement dated June 13, 2003 by and between Callisto
Pharmaceuticals, Inc. and Kunwar Shailubhai
10.3 Employment Agreement dated June 13, 2003 by and between Callisto
Pharmaceuticals, Inc. and Donald Picker
31.1 Certification of Chief Executive Officer required by Rule
13a-14(a)/15d-14(a) under the Exchange Act
31.2 Certification of Principal Financial Officer required by Rule
13a-14(a)/15d-14(a) under the Exchange Act
32.1 Certification of Chief Executive Officer pursuant to 18 U.S.C. Section
1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of
2002.
32.2 Certification of Principal Financial Officer pursuant to 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.
On May 15, 2003, we filed a Form 8-K describing a change in control of the
registrant and the acquisition of Synergy Pharmaceuticals, Inc.
On May 28, 2003, we filed a Form 8-K describing a press release announcing our
change of corporate domicile from Florida to Delaware and change of corporate
name from Webtronics, Inc. to Callisto Pharmaceuticals, Inc.
SIGNATURES
Pursuant to the requirements 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.
CALLISTO PHARMACEUTICALS, INC.
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(Registrant)
Date: August 19, 2003 /s/ Gary S. Jacob
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Gary S. Jacob
Acting Chief Executive Officer
Date: August 19, 2003 /s/ Bernard F. Denoyer
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Bernard F. Denoyer
Principal Financial Officer