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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
[X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934. For the quarterly period ended
March 31, 1997; or
[ ] 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
0-23076
Sparta Pharmaceuticals, Inc.
----------------------------------------------------
(Exact name of registrant as specified in its charter)
Delaware 56-1755527
-------- ----------
(State of incorporation) (IRS Employer Identification No.)
111 Rock Rd. Horsham, PA 19044
----------------------------------------------------------
(Address of principal executive offices, including zip code)
(215) 442-1700
--------------------------------------------------
(Registrant's telephone number, including area code)
Indicate by check mark whether the registrant (1) has filed all reports required
to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the preceding 12 months (or for such shorter period that the registrant was
required to file such reports), and (2) has been subject to such filing
requirements for the past 90 days. Yes [X] No [ ]
As of May 9, 1997, there were outstanding 10,045,994 shares of Common Stock,
$.001 par value per share.
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FORM 10-Q
QUARTERLY REPORT
--------------
INDEX
<TABLE>
<CAPTION>
Part I. FINANCIAL INFORMATION Page No.
-------
<S> <C> <C>
Item 1. Financial Statements:
Balance Sheets as of March 31, 1997 and December 31, 1996 3
Statements of Operations for the three-month periods March 31, 1997
and 1996 and for the period from June 12, 1990 (inception) to
March 31, 1997 (unaudited) 4
Statements of Cash Flows for the three-month periods ended
March 31, 1997 and 1996 and for the period from June 12, 1990
(inception) to March 31, 1997 (unaudited) 5
Notes to Financial Statements 6
Item 2. Management's Discussion and Analysis of Financial Condition
and Results of Operations 7
Part II. OTHER INFORMATION
Item 5. Other Information 10
Item 6. Exhibits and Reports on Form 8-K 10
SIGNATURES 11
</TABLE>
2
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PART I-FINANCIAL INFORMATION
- ----------------------------
ITEM 1. FINANCIAL STATEMENTS
SPARTA PHARMACEUTICALS, INC.
(A Development Stage Company)
Balance Sheets
(Unaudited)
<TABLE>
<CAPTION>
March 31, December 31,
1997 1996
-------------- --------------
Assets
Current assets:
<S> <C> <C>
Cash and cash equivalents $ 9,001,586 $ 10,246,812
Prepaid expenses and other assets 175,759 82,751
-------------- --------------
Total current assets 9,177,345 10,329,563
Fixed assets, net 469,640 518,393
Other assets:
License agreements, net of amortization
of $79,037 in 1997 and $73,303 in 1996 35,751 41,485
Restricted Cash 199,196 196,842
-------------- --------------
$ 9,881,932 $ 11,086,283
============== ==============
Liabilities and shareholders' equity
Current liabilities:
Accounts payable and accrued expenses $ 597,552 $ 629,497
-------------- --------------
Total current liabilities 597,552 629,497
Shareholders' equity:
Preferred Stock, not designated, $.001 par value;
authorized and unissued 8,266,868 shares --- ---
Series B' Convertible Preferred Stock, $.001 par value;
authorized 2,733,132 shares; issued and outstanding
1,429,604 shares in 1997 and 1,487,146 shares in 1996 1,430 1,487
Common Stock, $.001 par value; authorized 42,000,000
shares; issued and outstanding 9,971,328 shares in
1997 and 9,587,717 shares in 1996 9,971 9,588
Additional paid-in capital 28,209,779 28,176,356
Stock subscriptions receivable (200,000) (200,000)
Deferred compensation (184,069) (165,309)
Deficit accumulated during the development stage (18,552,731) (17,365,336)
-------------- --------------
Total shareholders' equity 9,284,380 10,456,786
-------------- --------------
$ 9,881,932 $ 11,086,283
============== =============
</TABLE>
The accompanying notes are an integral part of the financial statements.
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SPARTA PHARMACEUTICALS, INC.
(A Development Stage Company)
Statements of Operations
(Unaudited)
<TABLE>
<CAPTION>
Three Months Ended March 31 Period From
----------------------------------- June 12, 1990
(Inception) to
1997 1996 March 31, 1997
--------------
Revenue:
<S> <C> <C> <C>
Contract revenue $ 16,500 $ ---- $ 144,370
Interest income 125,627 18,713 714,019
----------- ----------- -------------
Total revenue 142,127 18,713 858,389
Operating expenses:
Research and development 986,376 292,858 10,167,523
General and administrative 343,146 312,503 6,180,684
Charge for acquired research
and development (Note 5) ---- 3,062,913 3,062,913
----------- ----------- -------------
Net loss $(1,187,395) $(3,649,561) $( 18,552,731)
=========== =========== =============
Net loss per share $ (.12) $ (.56)
=========== ==========
Weighted average number
of shares outstanding (Note 3) 9,768,055 6,559,557
=========== ==========
</TABLE>
The accompanying notes are an integral part of the financial statements.
4
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SPARTA PHARMACEUTICALS, INC.
(A Development Stage Company)
Statements of Cash Flows
(Unaudited)
<TABLE>
<CAPTION>
Three Months ended March 31, Period from June 12,
---------------------------------- 1990 (Inception) to
1997 1996 March 31, 1997
----------- --------- ------------
Operating activities:
<S> <C> <C> <C>
Net loss $(1,187,395) $(3,649,561) $(18,552,731)
Adjustments to reconcile net loss to net cash used in
operating activities:
Recognition of gain/loss on investments - - 3,316
Depreciation and amortization 54,487 15,314 779,247
Writedown of license agreement - - 45,200
Acquired research & development (Note 5) - 3,062,913 3,062,913
Issuance of convertible notes for services - - 220,474
Issuance of stock for services - - 161,445
Compensation expense related to stock options granted 14,989 2,147 294,518
Changes in operating assets and liabilities:
Prepaid expenses and other assets (93,008) 32,594 (175,759)
Restricted cash (2,354) - 48,153
Accounts payable and accrued expenses (31,945) 6,730 447,552
----------- --------- ------------
Net cash used in operating activities (1,245,226) (529,863) (13,665,672)
----------- --------- ------------
Investing activities:
Payment of acquisition related fees & expenses (80,000) (128,842)
Purchases of available-for-sale securities - (1,103,193)
Maturities of available-for-sale securities - - 1,099,877
Purchases of fixed assets - - (131,230)
Acquisition of license agreements - - (160,078)
----------- --------- ------------
Net cash used in investing activities - (80,000) (423,466)
----------- --------- ------------
Financing activities:
Proceeds from issuance of convertible notes and notes
payable - - 4,488,650
Repayment of notes payable - - (640,000)
Proceeds from issuance of Common Stock - 2,000 4,912,031
Repurchase of commnon stock - - (45)
Proceeds from issuance of Preferred Stock - 2,571,429 14,800,038
Increase in debt issuance costs - - (469,950)
----------- --------- ------------
Net cash provided by financing activities - 2,573,429 23,090,724
----------- --------- ------------
Increase (Decrease) in cash and cash equivalents (1,245,226) 1,963,566 9,001,586
Cash and cash equivalents at beginning of period 10,246,812 734,296 -
----------- --------- ------------
Cash and cash equivalents at end of period $ 9,001,586 $ 2,697,862 $ 9,001,586
=========== ========= ============
The accompanying notes are an integral part of the financial statements.
</TABLE>
5
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SPARTA PHARMACEUTICALS, INC.
(A Development Stage Company)
Notes to Financial Statements
(Unaudited)
1. Company Background
Sparta Pharmaceuticals, Inc. (formerly MediRx Pharmaceuticals, Inc.), a
development stage company incorporated in 1990, is engaged in the business of
acquiring rights to, and developing for commercialization, technologies and
drugs for the treatment of a number of life threatening diseases, including
cancer, cardiovascular disorders and acute inflammation.
The Company has generated no product revenues to date and has incurred
losses since its inception. The Company anticipates incurring additional losses
over at least the next several years and such losses are expected to increase as
the Company expands its research and development activities. Substantial
financing will be needed by the Company to fund its operations and to
commercially develop its products. There is no assurance that such financing
will be available when needed. Operations of the Company are subject to certain
risks and uncertainties including, among others, uncertainty of product
development, technological uncertainty, dependence on collaborative partners,
uncertainty regarding patents and proprietary rights, comprehensive government
regulations, marketing, or sales capability or experience, limited clinical
trial experience, and dependence on key personnel.
2. Basis of Presentation
The accompanying unaudited interim financial statements have been
prepared in accordance with generally accepted accounting principles for interim
financial information and with the instructions to Form 10-Q and Article 10 of
Regulation S-X. Accordingly, they do not include all of the information and
footnotes required by generally accepted accounting principles for complete
financial statements. In the opinion of management, all adjustments, consisting
only of normal recurring accruals, considered necessary for a fair presentation,
have been included in the accompanying unaudited financial statements. For more
complete financial information, these financial statements should be read in
conjunction with the audited financial statements and notes thereto contained in
the Company's 10-K for the fiscal year ended December 31, 1996. Results for the
interim periods are not necessarily indicative of the results for any other
interim period or for the full fiscal year.
3. Net Loss Per Share of Common Stock
The net loss per share amounts are presented in accordance with
Accounting Principles Bulletin No. 15. Under this guidance, options, warrants,
convertible debt and securities and other common stock equivalents are not
considered outstanding as their effect would be anti-dilutive for both primary
and fully diluted earnings per share computations.
In February 1997, the Financial Accounting Standards Board ("FASB")
issued Statement of Financial Accounting Standards ("SFAS") No. 128, "Earnings
Per Share", which the Company is required to adopt for both interim and annual
periods ending after December 15, 1997. SFAS No. 128 simplifies the earnings per
share ("EPS") calculation by replacing primary EPS with basic EPS. Basic EPS is
computed by dividing reported earnings available to common stockholders by the
weighted average shares outstanding. Early application is prohibited, although
footnote disclosure of pro forma EPS amounts is required. Since the Company has
incurred losses in both the three months ended March 31, 1997 and 1996, there is
no difference between pro forma basic EPS and the net loss per share as
reported.
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4. Shareholders' Equity
The Company's Series B' Convertible Preferred Stock, par value $.001
per share ("Series B' Preferred Stock") is convertible at any time at the option
of the holder into shares of the Company's Common Stock at an initial conversion
price of $1.50 per share such that 10,000 shares of the Company's Series B'
Preferred Stock are convertible into 66,667 shares of the Company's Common
Stock. In the event of a Liquidation Event (as defined in the Certificate of
Designation relating to the Series B' Preferred Stock), the holders of the
Series B' Preferred Stock are entitled to be paid out of the assets of the
Company available for distribution to its shareholders an amount equal to $13.00
per share, plus an amount equal to all declared and unpaid dividends thereon,
before any payment is made in respect of stock junior to the Series B' Preferred
Stock, including Common Stock. Holders of Series B' Preferred Stock are also
entitled to dividends, if any, as shall be declared on the Company's Common
Stock or on any other class of preferred stock, unless holders of at least 66
2/3% of the outstanding Series B' Preferred Stock consent otherwise. On August
23, 1997 the conversion rate of the Series B' Preferred Stock into shares of
Common Stock will be subject to increase if the average closing bid price of the
Common Stock for the 30 consecutive trading days immediately prior to August 23,
1997 is not greater than $1.95 per share. The outstanding Series B' Preferred
Stock is currently convertible into 9,455,947 shares of Common Stock.
5. Acquisition of the Business and Assets of Lexin Pharmaceutical
Corporation
On March 15, 1996, the Company acquired the business and assets, and
assumed certain liabilities of Lexin Pharmaceutical Corporation, for a payment
of 2,000,000 shares of the Company's Common Stock. The acquisition was accounted
for using the purchase method of accounting. In connection with the acquisition,
the Company performed an analysis of all identifiable assets acquired. The
Company recorded a total charge to the 1996 Statement of Operations of
$3,062,913 for acquired research and development. The development of the
technology acquired had not yet reached technological feasibility and at the
time, had no alternative future uses.
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
Since its inception in June 1990, the Company has been engaged in
acquiring and developing technologies and drug candidates for the treatment of
cancer and viral diseases and, through its acquisition of the assets and
business of Lexin Pharmaceutical Corporation ("Lexin"), cardiovascular disorders
and acute inflammation. Sparta has not derived revenues from the sale of any
products and expects to incur substantial operating losses for the next several
years. As of March 31, 1997, the Company's accumulated deficit was $18,552,731.
During the first quarter of 1997 Sparta began its first U.S. clinical
trial with SpartajectTM busulfan, at Johns Hopkins Oncology Center. Sparta's new
intravenous form of SpartajectTM busulfan is to be used as a myeloablative agent
in patients being prepared for bone marrow transplant. The Company was informed
by its corporate collaborator in the United Kingdom, the Cancer Research
Campaign, that the oral bioavailability of asulacrine, a product candidate which
the Company has an option to acquire, was sufficient in a Phase I trial to allow
further development. Additionally, the Company continued preparations for a
clinical trial of 5-fluoro pyrimidinone ("5-FP"), a prodrug which is converted
in the liver to 5-fluorouracil ("5-FU"), a widely prescribed chemotherapeutic
agent. Sparta has an ongoing Phase I clinical trial of RII retinamide for use in
myelodysplastic syndromes.
The Company has renegotiated its sublicensing agreement with Research
Triangle Pharmaceuticals, Ltd. ("RTP") related to the Spartaject Technology. In
consideration of RTP's climination of the requirement that certain milestones be
achieved by fixed dates and the reduction of the on-going license and
maintenance fees, the Company has agreed to restrict its field of use of the
Spartaject Technology to busulfan, aphidicolin (and aphidicolin glycinate), a
compound currently undergoing feasibility evaluation and an additional anti-
cancer compound to be determined at a later date. Furthermore, RTP and the
Company may pursue a joint venture to evaluate and develop paclitaxel and
related derivatives. If the terms of the joint venture are not agreed to by the
end of 1997, RTP can license the rights to paclitaxel to another party.
Results of Operations
Three Months Ended March 31, 1996 and 1997
Revenue increased from $18,713 for the three months ended March 31,
1996 to $142,127 for the three months ended March 31, 1997 due primarily to a
higher level of interest income. Interest income increased from $18,713 in the
first quarter of 1996 to $125,627 in the first quarter of 1997 due to a higher
level of funds available for investment as a
7
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result of a private placement which occurred in August 1996. Interest income is
likely to decrease in subsequent quarters as funds are consumed by the
operations of the Company, unless the Company is able to secure additional
funding. The amount of revenues may vary significantly year-to-year and
quarter-to-quarter and depend on, among other factors, the timing and amount of
future financings and the potential awarding of future grants and contracts. The
Company recorded contract revenues of $16,500 for the three months ended March
31, 1997 related to a feasibility study being conducted for a pharmaceutical
company.
Research and development expenses increased from $292,858 in the first
quarter of 1996 to $986,376 in the first quarter of 1997. This is attributable
to increased outside development expenditures on certain drug candidates during
the first quarter of 1997, increased legal expenses for patent filings, and
increased personnel and facility-related expenses resulting from the
acquisition, on March 15, 1996, of the business and assets of Lexin. Subject to
the receipt of additional funding, the Company expects research and development
expenses to increase during the next several years as product development,
preclinical and clinical trials, and regulatory activities increase.
General and administrative expenses increased from $312,503 in the
first quarter of 1996 to $343,146 in the first quarter of 1997. This increase is
principally due to increased expenditures in the areas of personnel and
facility-related expenses as a result of the Lexin purchase, offset by a
decrease in financial advisory fees.
In connection with the Lexin purchase, the Company recorded a total
charge to the 1996 Statement of Operations of $3,062,913 for acquired research
and development.
The Company expects to incur substantial operating losses over the next
several years. The amount of net losses may vary significantly from year-to-year
and quarter-to-quarter and depend on, among other factors, the timing of
research and the progress of preclinical and clinical development programs.
Liquidity and Capital Resources
The Series B' Preferred Stock is convertible at any time at the option
of the holder into shares of the Company's Common Stock at an initial conversion
price of $1.50 per share such that 10,000 shares of the Company's Series B'
Preferred Stock are convertible into 66,667 shares of the Company's Common
Stock. In the event of a Liquidation Event (as defined in the Certificate of
Designation relating to the Series B' Preferred Stock), the holders of the
Series B' Preferred Stock are entitled to be paid out of the assets of the
Company available for distribution to its shareholders an amount equal to $13.00
per share, plus an amount equal to all declared and unpaid dividends thereon,
before any payment is made in respect of stock junior to the Series B' Preferred
Stock, including Common Stock. Holders of Series B' Preferred Stock are also
entitled to dividends, if any, as shall be declared on the Company's Common
Stock or on any other class of preferred stock, unless holders of at least 66
2/3% of the outstanding Series B' Preferred Stock consent otherwise. On August
23, 1997 the conversion rate of the Series B' Convertible Preferred Stock into
shares of Common Stock will be subject to increase if the average closing bid
price of the Common Stock for the 30 consecutive trading days immediately prior
to August 23, 1997 is not greater than $1.95 per share. The outstanding Series
B' Preferred Stock is currently convertible into 9,455,947 shares of Common
Stock.
The Company has used $13,665,672 to fund operations from inception
through March 31, 1997. The Company has financed its operations to date from the
proceeds of its initial public offering in June and July 1994, private
placements of equity and convertible debt securities and investment income. In
1997, the Company is obligated under its license agreements to make minimum
royalty payments and an annual maintenance fee in the aggregate of $182,000, of
which $25,000 had been paid as of May 5, 1997. Under a collaboration and option
agreement, the term of which has been extended, the Company may have to make
payments of up to $105,000 based on the fulfillment of certain benchmarks. This
agreement is denominated in a foreign currency and is subject to the
fluctuations of exchange rates. The Company is a party to several research
agreements, clinical trial production contracts and agreements with clinical
research organizations which require future payments. The Company anticipates
making aggregate payments of approximately $1,053,879 under the agreements which
were in effect as of May 5, 1997. Provided that there is adequate
8
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financing, the amount of the Company's obligations under research agreements can
be expected to increase. In addition, the Company is a party to employment
agreements with three of its executive officers and a former executive officer
as well as certain consulting agreements which provide for aggregate annual,
minimum payments of $650,000 and $162,000, respectively, of which $541,000 is
still owed as of May 5, 1997. The Company is a party to an operating lease
agreement which will require the Company to make payments of approximately
$100,000 in 1997, of which approximately $40,000 has already been paid. The
agreement also requires the Company to pay a certain amount of contingent
rentals based upon operating, maintenance, management, and repair expenses
incurred by the lessor. The Company has contracted with a contract research
organization to provide drug development services which are to be paid for with
a combination of cash and Common Stock.
As of March 31, 1997, the Company had cash and cash equivalents of
$9,001,586, accounts payable and accrued expenses of $597,552, and working
capital of $8,579,793.
The Company currently anticipates that the available cash, cash
equivalents, and investments will be sufficient to fund operations through the
first quarter of 1998. However, the Company may be required to obtain additional
financing to continue operations during such period in the event of cost
overruns or unanticipated expenses. Continuing development of the Company's
product candidates is critical and will require substantial additional funds to
finance such activities on an ongoing basis. The Company's future capital
requirements will depend on numerous factors, including, but not limited to,
progress in its research and development programs, including preclinical and
clinical trials, costs of filing and prosecuting patent applications and, if
necessary, enforcing issued patents or obtaining additional licenses of patents,
competing technological and market developments, the cost and timing of
regulatory approvals, the ability of the Company to establish collaborative
relationships, and the cost of establishing manufacturing, sales and marketing
capabilities. The Company has no current commitment to obtain additional funding
and is unable to state the amount or potential source of such additional funds.
Moreover, because of the Company's potential long-term capital requirements, it
may undertake additional equity offerings whenever conditions are favorable,
even if it does not have an immediate need for additional capital at that time.
There can be no assurance that the Company will be able to obtain additional
funding when needed, or that such funding, if available, will be obtainable on
reasonable terms. Any such additional funding may result in significant dilution
to existing stockholders. If adequate funds are not available, the Company may
be required to delay, reduce or eliminate research and development programs,
capital expenditures, and other operating expenses. The Company may be required
to obtain funds through arrangements with collaborative partners that may
require the Company to relinquish certain material rights to its products that
it would not otherwise relinquish.
Continued inclusion of the Company's Common Stock for quotation on the
Nasdaq SmallCap Market will require that (i) the Company maintain at least
$2,000,000 in total assets and $1,000,000 in capital and surplus, (ii) the
minimum bid price for the Common Stock be at least $1.00 per share (unless it
maintains a public float of at least $1,000,000 and $2,000,000 in capital and
surplus), (iii) the public float consist of at least 100,000 shares of Common
Stock , valued in the aggregate at more than $200,000, (iv) the Common Stock
have at least two active market makers and (v) the Common Stock be held by at
least 300 holders. Although the Company currently meets the listing criteria and
has no reason to believe that it will not continue to meet such criteria, there
can be no assurance that future events will not result in the Company's failure
to meet all of the criteria for continued listing. In such event, trading, if
any, in the Common Stock would thereafter be conducted in the over-the-counter
market in the so-called "pink sheets" or the NASD's "Electronic Bulletin Board",
and it would be more difficult to dispose of the securities or to obtain as
favorable a price for the securities. Consequently, the liquidity of the
securities could be impaired, not only in the number of securities that could be
bought and sold at a given price, but also through delays in the timing of
transactions and reduction in security analysts' and the media's coverage of the
Company, which could result in lower prices for the securities than might
otherwise be attained and in a larger spread between the bid and asked prices
for the securities.
9
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PART II-OTHER INFORMATION
- -------------------------
ITEM 5. Other Information
On February 10, 1997, Sparta issued the press release filed as Exhibit
99.11 hereto announcing the addition of 5 new clinical trial sites for
RII Retinamide.
On March 4, 1997, Sparta issued the press release filed as Exhibit
99.12 hereto announcing the progress of asulacrine trials in the United
Kingdom.
On March 16, 1997, Sparta issued the press release filed as Exhibit
99.13 hereto announcing, in conjunction with Yale University, the
notification of allowance of claims in the patent application entitled,
"Determination of Prodrugs Metabolizable by the Liver and Therapeutic
Use Thereof."
On March 24, 1997, Sparta issued the press release filed as Exhibit
99.14 hereto announcing the initiation of Phase I clinical trials using
SpartajectTM busulfan at Johns Hopkins Oncology Center.
ITEM 6. Exhibits and Reports on Form 8-K
(a) Exhibits
Exhibit No. Description
*!10.8 -- Amended and Restated Sublicense Agreement, dated January 1,
1997, between the Registrant and Research Triangle
Pharmaceuticals Ltd. ("RTP").
27 -- Financial Data Schedule
99.11 -- Press Release, dated as of February 10, 1997, announcing
the addition of 5 new clinical trial sites for RII
Retinamide.
99.12 -- Press Release, dated as of March 4, 1997, announcing the
progress of asulacrine trials in the United Kingdom.
99.13 -- Press Release, dated as of March 16, 1997, announcing, in
conjunction with Yale University, the notification of
allowance of claims in the patent application entitled,
"Determination of Prodrugs Metabolizable by the Liver and
Therapeutic Use Thereof."
99.14 -- Press Release, dated as of March 24, 1997, announcing the
initiation of Phase I clinical trials using SpartajectTM
busulfan at Johns Hopkins Oncology Center.
---------------
* Previously filed with the Company's 1996 Annual Report on Form 10-K,
filed on March 27, 1997, and incorporated by reference herein.
! Confidential Treatment has been granted by the Securities and Exchange
Commission.
(b) Reports on Form 8-K
The Company filed the following reports on Form 8-K during the quarter:
None.
10
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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.
Sparta Pharmaceuticals, Inc.
May 12, 1997 By: /s/ Jerry B. Hook
------------ -------------------------------------
Date Jerry B. Hook, Ph.D.
President and Chief Executive Officer
(principal executive officer) and Director
May 12, 1997 By: /s/ Ronald H. Spair
------------ ------------------------------------
Date Ronald H. Spair
Vice President and Chief Financial
Officer (principal financial officer)
11
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Exhibit 99.11
<TABLE>
<CAPTION>
<S> <C> <C>
Contacts: Jerry B. Hook, Ph.D. William McCulloch, M.B.,Ch.B.,F.R.C.P.(glasg.),D.R.C.O.G.
President & CEO Senior VP, Research & Development
Sparta Pharmaceuticals, Inc. Sparta Pharmaceuticals, Inc.
(215) 442-1700, Ext. 205 (919) 361-3462
</TABLE>
FOR IMMEDIATE RELEASE
Sparta Pharmaceuticals, Inc. Announces 5 New Clinical Trial Sites
for RII Retinamide
-----------------------------------------------------------------
Horsham, PA, February 10, 1997, Sparta Pharmaceuticals, Inc. (NASDAQ:
SPTA, SPTAU, SPTAW, SPTAZ AND SPTAL) announces the addition of 5 new clinical
trial sites for RII Retinamide, a retinoid compound, for the treatment of
myelodysplastic syndromes. Clinical trials for RII Retinamide began on August
30, 1996.
Sparta has been approved to treat individual patients for several weeks with RII
Retinamide, and the use of additional clinical centers with additional patients
will decrease total duration of this important trial. The trial is designed to
evaluate safety, tolerability and pharmacokinetics after multiple dose
administration.
Myelodysplastic syndromes, or MDS, are a group of conditions characterized by
the failure to produce normal blood cells leading to bone marrow failure or
leukemia and eventually death. Retinoids, which are derivatives of Vitamin A,
were first discovered by Chinese scientists to have therapeutic effects on
certain types of leukemia and other serious diseases. They work by a mechanism
referred to as "re-differentiation" to normalize cells that have become
abnormal, or dysplastic.
Sparta has an exclusive worldwide license (excluding China) of RII Retinamide
from the Institute of Materia Medica in Beijing, China and has one of the
foremost Chinese scientists in this field, Dr. Jui (Rui) Han.
Sparta is a development stage pharmaceutical company engaged in the business of
acquiring rights to, and developing for commercialization, technologies and
drugs for the treatment of life threatening diseases including cancer,
cardiovascular disorders and inflammation. The Company has focused on acquiring
compounds that have been previously tested in humans and animals and
technologies that may improve the delivery or targeting of previously tested,
and in some cases marketed, anticancer agents. Sparta's foundation in cancer
chemotherapy has recently been augmented by the addition of new technology in
the rapidly expanding field of serine protease inhibitors. Serine protease
inhibitors have wide applications in diverse fields such as inflammation,
reperfusion injury and stroke.
This news release contains forward-looking statements within the meaning of the
"safe harbor" provisions of the Private Securities Litigation Reform Act of
1995. Such statements are made based on management's current expectations and
beliefs, and actual results may vary from those currently anticipated based upon
a number of factors including, uncertainties inherent in the drug development
process, including clinical trials. The company undertakes no obligation to
release publicly any revisions
<PAGE>
which may be made to reflect events or circumstances after the date hereof.
<PAGE>
Exhibit 99.12
<TABLE>
<CAPTION>
<S> <C> <C>
Contacts: Jerry B. Hook, Ph.D. William McCulloch, M.B.,Ch.B.,F.R.C.P.(glasg.),D.R.C.O.G.
President & CEO Senior VP, Research & Development
Sparta Pharmaceuticals, Inc. Sparta Pharmaceuticals, Inc.
(215) 442-1700, Ext. 205 (919) 361-3462
</TABLE>
FOR IMMEDIATE RELEASE
Sparta Pharmaceuticals, Inc. Announces Progress of Asulacrine Trials in U.K.
Horsham, PA, March 4, 1997, Sparta Pharmaceuticals, Inc. (NASDAQ: SPTA,
SPTAU, SPTAW, SPTAZ and SPTAL) announces that their collaborators in the United
Kingdom, the Cancer Research Campaign (CRC) have reported that the oral
bioavailability of asulacrine is sufficient to allow further development of that
formulation. The previous Phase I trial, which used an intravenous formulation,
was completed in late 1995, but toxicity of the i.v. formulation to veins led to
the development of the current oral form. Sparta anticipates that an abbreviated
oral Phase I will quickly be followed by Phase II trials in light of the new
information.
According to Dr. William McCulloch, Sparta's Senior Vice President of Research
and Development, "These results are encouraging. This documentation of oral
bioavailability should allow us to proceed with Phase I and II trials in the
near future."
"We are pleased with these results provided by our partners in this effort and
look forward to efficacy trials in breast and non-small cell lung cancer in the
near future," said Dr. Jerry B. Hook, President and Chief Executive Officer of
Sparta. Breast and lung cancer are the two most common forms of cancer, with
approximately 186,000 and 177,000 people diagnosed per year, respectively, in
the United States.
This news release contains forward-looking statements within the meaning of the
"safe harbor" provisions of the Private Securities Litigation Reform Act of
1995. Such statements are made based on management's current expectations and
beliefs, and actual results may vary from those currently anticipated based upon
a number of factors including, uncertainties inherent in the drug development
process, including clinical trials. The company undertakes no obligation to
release publicly any revisions which may be made to reflect events or
circumstances after the date hereof.
Sparta is a development stage pharmaceutical company engaged in the business of
acquiring rights to, and developing for commercialization, technologies and
drugs for the treatment of a number of life threatening diseases, including
cancer, cardiovascular disorders and inflammation. The Company has focused on
acquiring compounds that have been previously tested in humans and animals and
technologies that may improve the delivery or targeting of previously tested,
and in some cases marketed, anticancer agents. Sparta's foundation in cancer
chemotherapy has recently been augmented by the addition of new technology in
the rapidly expanding field of serine protease inhibitors. Serine protease
inhibitors have wide applications in diverse fields such as inflammation,
reperfusion injury and stroke.
<PAGE>
Exhibit 99.13
<TABLE>
<CAPTION>
<S> <C> <C>
Contacts: Jerry B. Hook, Ph.D. William McCulloch, M.B.,Ch.B.,F.R.C.P.(glasg.),D.R.C.O.G.
President & CEO Senior VP, Research & Development
Sparta Pharmaceuticals, Inc. Sparta Pharmaceuticals, Inc.
(215) 442-1700, Ext. 205 (919) 361-3462
</TABLE>
FOR IMMEDIATE RELEASE
Sparta Pharmaceuticals, Inc., in Conjunction with Yale University, Has Received
Notification of Allowance of Invention, "Determination of Prodrugs Metabolizable
and Therapeutic Use Thereof"
Horsham, PA, March 16, 1997 -- Sparta Pharmaceuticals, Inc. (NASDAQ:
SPTA, SPTAU, SPTAW, SPTAZ and SPTAL) today announced that they received
notification from the United States Patent and Trademark Office of allowance of
claims in the patent application entitled, "Determination of prodrugs
metabolizable by the liver and therapeutic use thereof." Dr. Yung-chi Cheng of
Yale University will be the patent holder, and Sparta has licensed exclusive
worldwide rights to the use of the patent from Yale.
This patent, when issued, will cover Sparta's L.A.D.D.TM (Liver Associated
Disease Delivery) Technology Program which involves the formulation and
administration of pro-drugs which remain inactive until converted into active
agents by an enzyme located in the liver. Sparta is actively developing the
prodrugs 5-FP and IPdR which are converted in the liver to 5- fluorouracil
(5-FU), a widely prescribed chemotherapeutic agent, and iodo-deoxyuridine
(IUdR), a radiosensitizing agent currently in clinical development. Sparta's
clinical trials of 5-FP are slated to begin in the near future.
Dr. William McCulloch, Sparta's Senior Vice President of Research and
Development, said, "This patent will give Sparta added protection for the
valuable asset which we have licensed from Yale University. It not only covers
drugs currently in development, but also future compounds which we hope to
develop under the L.A.D.D.TM Technology."
This press release contains certain forward-looking statements within the
meaning of the "safe harbor" provisions of the Private Securities Litigation
Reform Act of 1995. Such statements are made based on management's current
expectations and beliefs, and actual results may vary from those currently
anticipated based upon a number of factors, including uncertainties inherent in
the drug development process, including clinical trials. The Company undertakes
no obligation to release publicly any revisions which may be made to reflect
events or circumstances after the date hereof.
Sparta is a development stage pharmaceutical company engaged in the business of
acquiring rights to, and developing for commercialization, technologies and
drugs for the treatment of a number of life threatening diseases, including
cancer, cardiovascular disorders and inflammation. The Company has focused on
acquiring compounds that have been previously tested in humans and animals and
technologies that may improve the delivery or targeting of previously tested,
and in some cases marketed, anticancer agents. Sparta's foundation in cancer
chemotherapy has recently been augmented by the
<PAGE>
addition of new technology in the rapidly expanding field of serine protease
inhibitors. Serine protease inhibitors have wide applications in diverse fields
such as inflammation, reperfusion injury and stroke.
<PAGE>
Exhibit 99.14
<TABLE>
<CAPTION>
<S> <C> <C>
Contacts: Jerry B. Hook, Ph.D. William McCulloch, M.B.,Ch.B.,F.R.C.P.(glasg.),D.R.C.O.G.
President & CEO Senior VP, Research & Development
Sparta Pharmaceuticals, Inc. Sparta Pharmaceuticals, Inc.
(215) 442-1700, Ext. 205 (919) 361-3462
</TABLE>
FOR IMMEDIATE RELEASE
Sparta Pharmaceuticals, Inc. Announces Initiation of Busulfan Clinical Trial at
Johns Hopkins Oncology Center
Horsham, PA, March 24, 1997, Sparta Pharmaceuticals, Inc. (NASDAQ: SPTA,
SPTAU, SPTAW, SPTAZ and SPTAL) announces initiation of a Phase I clinical trial
using SpartajectTM busulfan at Johns Hopkins Oncology Center (JHOC). Sparta's
new intravenous form of Spartaject(TM) busulfan is to be used as a myeloablative
agent in patients being prepared for bone marrow transplant. SpartajectTM
technology allows for the injection of water insoluble materials without the use
of solubilizing agents which may be irritating or cause other unwanted side
reactions.
Dr. Louise Grochow will conduct the trial at JHOC. It was at JHOC that the
high-dose busulfan and cyclophosphamide regimen was developed for this purpose
in the 1970s.
Dr. William McCulloch, Sparta's Senior Vice President of Research and
Development, stated, "The use of our injectable formulation of busulfan prior to
transplants is intended to eliminate the need for patients to ingest the large
number of tablets currently required for such procedures and reduce the
potential for unpredictable and serious toxicities arising from the variations
in absorption experienced with the use of the oral form."
Sparta is a development stage pharmaceutical company engaged in the business of
acquiring rights to, and developing for commercialization, technologies and
drugs for the treatment of a number of life threatening diseases including
cancer, cardiovascular disorders and inflammation. The Company has focused on
acquiring compounds that have been previously tested in humans and animals and
technologies that may improve the delivery or targeting of previously tested,
and in some cases marketed, anticancer agents. Sparta's foundation in cancer
chemotherapy has recently been augmented by the addition of new technology in
the rapidly expanding field of serine protease inhibitors. Serine protease
inhibitors have wide applications in diverse fields such as inflammation,
reperfusion injury and stroke.
This news release contains certain forward-looking statements within the meaning
of the "safe harbor" provisions of the Private Securities Litigation Reform Act
of 1995. Such statements are made based on management's current expectations and
beliefs, and actual results may vary from those currently anticipated based upon
a number of factors, including uncertainties inherent in the drug development
process, including clinical trials. The Company undertakes no obligation to
release publicly any revisions which may be made to reflect events or
circumstances after the date hereof.
<TABLE> <S> <C>
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<LEGEND>
THIS SCHEDULE CONTAINS SUMMARY FINANCIAL INFORMATION EXTRACTED FROM THE
FINANCIAL STATEMENTS INCLUDED IN THE COMPANY'S MARCH 31, 1997 REPORT ON FORM
10-Q AND IS QUALIFIED IN ITS ENTIRETY BY REFERENCE TO SUCH FINANCIAL STATEMENTS.
</LEGEND>
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