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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-QSB
Quarterly Report Under Section 13 or 15(d)
of the Securities Exchange Act of 1934
For the quarterly period ended March 31, 2000 Commission file number 0-18170
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ALPHA 1 BIOMEDICALS, INC.
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(Exact name of small business issuer as specified in its charter)
Delaware 52-1253406
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(State of Incorporation) (IRS Employer I.D. Number)
3 Bethesda Metro Center
Suite 700
Bethesda, Maryland 20814
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(Address of principal executive offices)
Issuer's telephone number, including area code: (301) 961-1992
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Check whether the issuer (1) filed all reports required to be filed by Section
13 or 15(d) of the Exchange Act during the past 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 No X
19,477,429 shares of Alpha 1 Biomedicals, Inc. Common Stock, par value $.001
per share, were outstanding as of October 31, 2000.
Transitional Small Business Disclosure Format (Check One) Yes [ ] No [X]
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ALPHA 1 BIOMEDICALS, INC.
FORM 10-QSB
QUARTER ENDED MARCH 31, 2000
INDEX
<TABLE>
<CAPTION>
Part I. Financial Information Page No.
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<S> <C> <C>
Item 1. Financial Statements
Balance Sheets at March 31, 2000 (unaudited)
and December 31, 1999 3
Statements of Operations for the three months
ended March 31, 2000 and March 31, 1999
(unaudited) 4
Statements of Cash Flows for the three months
ended March 31, 2000 and March 31, 1999
(unaudited) 5
Notes to Financial Statements (unaudited) 6-7
Item 2. Management's Discussion and Analysis or Plan of
Operation 7-11
Part II. Other Information
Item 1. Legal Proceedings 12
Item 2. Changes in Securities and Use of Proceeds 12
Item 6. Exhibits and Reports on Form 8-K 12
Signatures 13
</TABLE>
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ITEM 1.
ALPHA 1 BIOMEDICALS, INC.
BALANCE SHEETS
<TABLE>
<CAPTION>
March 31, December 31,
2000 1999
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(unaudited)
<S> <C> <C>
ASSETS
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Current assets
Cash and cash equivalents $ 542,356 $ 43,387
Investment in SciClone 963,596 886,122
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Total current assets 1,505,952 929,509
Fixed assets, net 1,706 1,889
Due from related party, net of allowance 965 965
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Total assets $ 1,508,623 $ 932,363
===================== ====================
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)
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Current liabilities
Accounts payable $ 71,700 $ 273,385
Accrued expenses 37,121 58,861
Notes payable - 301,722
Letter agreements with vendors 164,823 693,394
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Total current liabilities 273,644 1,327,362
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Stockholders' equity (deficit)
Preferred stock, $.001 par value per share,
1,000,000 authorized; no shares issued - -
Common stock, par value $.001 per share,
20,000,000 shares authorized; 19,477,429
and 11,977,429 issued and outstanding, respectively 19,477 11,977
Additional paid-in capital 36,407,789 36,115,289
Accumulated deficit (35,725,154) (37,005,591)
Accumulated other comprehensive income 832,867 483,326
Stock subscription (300,000) -
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Total stockholders' equity (deficit) 1,234,979 (394,999)
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Total liabilities and stockholders' equity (deficit) $ 1,508,623 $ 932,363
===================== ====================
</TABLE>
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ALPHA 1 BIOMEDICALS, INC.
STATEMENTS OF OPERATIONS
<TABLE>
<CAPTION>
(Unaudited)
Three months ended
March 31,
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2000 1999
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<S> <C> <C>
Revenues $ - $ -
Expenses
Research and product development 53,839 -
General and administrative 58,833 7,206
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Total expenses 112,672 7,206
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Operating loss (112,672) (7,206)
Realized gain (loss) on sale of investments 646,059 (365,868)
Interest expense - (4,281)
Interest income 22 -
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Income (loss) before extraordinary items 533,409 (377,355)
Extraordinary item - settlement of vendor payables 584,201 -
Extraordinary item - settlement of note payable & interest 162,827 -
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Net income (loss) $ 1,280,437 $ (377,355)
==================== ====================
Basic and diluted net income (loss) per common share
before extraordinary items $ 0.03 $ (0.03)
Extraordinary items - settlement of payables/debt 0.05 -
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Basic and diluted net income (loss) per common share $ 0.08 $ (0.03)
==================== ====================
Weighted average number of common shares outstanding 16,757,649 11,977,429
==================== ====================
</TABLE>
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ALPHA 1 BIOMEDICALS, INC.
STATEMENTS OF CASH FLOWS
<TABLE>
<CAPTION>
(Unaudited)
Three months ended
March 31,
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2000 1999
---- ----
<S> <C> <C>
Cash flows from operating activities:
Net income (loss) $ 1,280,437 $ (377,355)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation 183 -
Realized (gain) loss on sale of investments (646,059) 365,868
Settlement of vendor payables (584,201) -
Settlement of note payable (139,222) -
Changes in operating assets and liabilities:
Decrease in due from related party - (1,142)
Decrease in accounts payable (146,055) (80,063)
Decrease in accrued expenses (21,740) (28,456)
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Net cash used in operating activities (256,657) (121,148)
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Cash flows from investing acctivities:
Cash received on sale of investments 918,126 166,006
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Net cash provided by investing activities 918,126 166,006
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Cash flows from financing activities:
Repayment of notes payable (162,500) (47,256)
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Net cash used in financing activities (162,500) (47,256)
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Net increase (decrease) in cash and cash equivalents 498,969 (2,398)
Cash and cash equivalents at beginning of period 43,387 2,698
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Cash and cash equivalents at end of period $ 542,356 $ 300
================= ==================
</TABLE>
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ALPHA 1 BIOMEDICALS, INC.
NOTES TO FINANCIAL STATEMENTS
For the three months ended March 31, 2000 and 1999 (Unaudited)
A. GENERAL
Alpha 1 Biomedicals, Inc. (the "Company"), a Delaware corporation, was
incorporated in 1982. The Company operates predominately in a single
industry segment, the biotechnology industry, which consists of
researching and developing new pharmaceutical products for the treatment
of diseases or conditions that arise as a result of immune system
disorders, including chronic viral infections, cancer and autoimmune
disease. The Company suspended its operations in September 1998 due to
insufficient funds and did not resume operations until August 1999.
In early 1996, the Company substantially halted its development program
and all other research and currently has no products that have received
regulatory approval. During 1997, the Company entered into a Material
Transfer Agreement - Cooperative Research and Development Agreement with
the National Institutes of Health ("NIH"), pursuant to which an NIH
investigator used Thymosin beta 4 provided by the Company in
pre-clinical animal studies for the treatment of non-healing wounds. In
exchange for providing the product and other data, the Company received
an option to elect to negotiate for an exclusive or non-exclusive
commercialization license from the NIH pursuant to a patent application
filed by NIH in 1998. The Company's option expired on February 11, 1999.
The Company's President is named as a co-inventor on the patent
application filed by the NIH. As a result, he retains an equal,
undivided interest in the intellectual property described in the patent
application, which he subsequently assigned to the Company for nominal
consideration on May 1, 2000. The Company therefore shares equally with
the NIH all rights to the intellectual property which might be
forthcoming under the patent application, resulting in full but
non-exclusive rights. Currently, the Company is negotiating with the NIH
to license the NIH's rights under the patent application in order to
effectively secure an exclusive proprietary position.
In August 1999, the Company contracted with a group of four consultants,
including the Company's President, to advise the Company on the most
viable approaches for raising the necessary capital to continue business
operations and funding research and development. At this time the
Company resumed operations. The consultants each received compensation
in the form of 1,875,000 stock options, exercisable at $.04 per share.
On February 3, 2000 each consultant exercised all of his outstanding
options in return for a three-year note for $75,000 each, secured by the
shares issued and bearing interest at 6.09% per annum. In addition, one
consultant receives a monthly fee of $8,000 (increased from $5,000 per
month effective August 2000) and another consultant (the Company's
President) receives a monthly fee of $5,000 per month ($2,000 of which
is withheld by the Company as partial repayment of certain of the
President's outstanding indebtedness to the Company other than the note
payable for the option exercise).
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B. FINANCIAL STATEMENTS
The Balance Sheet as of March 31, 2000, the Statements of Operations for
the three-month periods ended March 31, 2000 and March 31, 1999, and the
Statements of Cash Flows for the three-month periods ended March 31,
2000 and March 31, 1999, have been prepared without audit. In the
opinion of management, all adjustments necessary to present fairly the
financial position, results of operations, and cash flows at March 31,
2000, and for the period then ended, have been recorded. All adjustments
recorded were of a normal recurring nature.
Certain information and footnote disclosures normally included in
financial statements prepared in accordance with generally accepted
accounting principles have been condensed or omitted. These consolidated
financial statements should be read in conjunction with the financial
statements and notes thereto for the year ended December 31, 1999
included in the Company's Annual Report on Form 10-KSB for the year
ended December 31, 1999.
The results of operations for the three-month period ended March 31,
2000 are not necessarily indicative of the operating results anticipated
for the full year.
C. NET LOSS PER SHARE
Net loss per share is based on the weighted average number of common
shares outstanding during the three-month periods ended March 31, 2000
and March 31, 1999. No effect has been given to unexercised stock
options or warrants because the effect would be anti-dilutive.
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OR PLAN OF OPERATION
This item should be read in conjunction with the unaudited financial
statements and notes thereto of the Company contained in Item 1 of this
report.
FORWARD-LOOKING STATEMENTS
When used in this Form 10-QSB and in future filings by the Company with the
Securities and Exchange Commission, in the Company's press releases or other
public or shareholder communications, and in oral statements made with the
approval of an authorized executive officer, the words or phrases "will likely
result," "are expected to," "will continue," "is anticipated," "estimate,"
"project" or similar expressions are intended to identify "forward-looking
statements" within the meaning of the Private Securities Litigation Reform Act
of 1995. These statements are subject to certain risks and uncertainties, that
could cause actual results to differ materially from historical results and
those presently anticipated or projected. The Company wishes to caution
readers not to place undue reliance on any forward-looking statements, which
speak only as of the date made. The Company wishes to advise readers that
various factors could affect the Company's financial performance and could
cause the Company's actual results for future periods to differ materially
from any opinions or statements expressed with respect to future periods in
any current statements. These factors include, but are not limited to, the
following: the Company's lack of revenues and history of losses; uncertainties
related to the Company's limited capital resources; risks associated with the
development of the Company's products; the Company's lack of product
diversification; the Company's dependence on collaborative relationships with
larger partners for the development,
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manufacturing and marketing of its products; reliance upon key personnel; the
Company's ability to obtain and protect intellectual property rights; and
competition. For a discussion of these and other factors, see Exhibit 99.1 to
the Company's Annual Report on Form 10-KSB for the year ended December 31,
1999.
The Company does not undertake--and specifically declines any obligation--to
publicly release the result of any revisions which may be made to any
forward-looking statements to reflect events or circumstances after the date
of such statements or to reflect the occurrence of anticipated or
unanticipated events.
PLAN OF OPERATIONS
As noted above, the Company resumed operations in August 1999 after suspending
operations in September 1998 due to lack of funding. The Company currently has
no products that have received regulatory approval. The Company has not
generated significant revenues from operations and does not anticipate
generating product revenues or other revenues from operations for the
foreseeable future. As of March 31, 2000, the Company's current assets
consisted of a balance of cash and cash equivalents of $542,356 and 62,673
shares of the common stock of SciClone Pharmaceuticals, Inc. ("SciClone"),
valued at approximately $963,596, which the Company received in connection
with its sale of certain royalty rights to SciClone in 1998. Although no
assurance can be given, the Company believes that it will be able to satisfy
its cash requirements through December 31, 2001 by utilizing its existing
balance of cash and cash equivalents and by selling shares of SciClone common
stock, as needed. If additional funds are not raised by that point, or the
value of its SciClone stock declines significantly, the Company likely will be
forced to again suspend or discontinue operations.
The Company utilizes a virtual company strategy in order to effectively
control costs. The Company will contract out research and development and
manufacturing operations, as well as other functions critical to its mission.
The Company believes this approach enhances its ability to allocate resources
rapidly to different projects. The strategy consists of (i) identifying,
evaluating and licensing pharmaceutical product opportunities that appear to
have significant commercial potential; (ii) designing pre-clinical and/or
clinical protocols to test such products; (iii) utilizing third party contract
manufacturers to supply clinical grade material and third party contract
research organizations to perform pre-clinical and/or clinical studies in
accordance with its designed protocols; and (iv) pursuing sublicense
arrangements with established pharmaceutical companies to support late stage
clinical testing and ultimately marketing if regulatory approval is obtained.
The Company's current primary business focus is the commercialization of
Thymosin beta 4 ("T(beta)4"), a 43 amino acid peptide. The Company is
concentrating its product development efforts on the use of T(beta)4 for the
treatment of injured tissue and non-healing wounds to enable more rapid repair
and/or tissue regeneration. Toward this end, the Company in 1997 entered into an
agreement with the NIH pursuant to which the Company provided an NIH
investigator with T(beta)4 for testing in animal models in a wound healing
study. A provisional patent application was filed by NIH in July 1998, with a
Patent Cooperation Treaty (PCT) application filed in July 1999, pertaining to
the work performed on T(beta)4. Due to the suspension of operations by the
Company in 1998, the Company did not exercise its rights under the agreement to
license T(beta)4 from the NIH following notification of the patent application
filing. Dr. Goldstein, however, was named as a co-inventor on the patent
application filed by the NIH, and since he assigned these rights for nominal
consideration to the Company in May 2000, the Company retains a shared right to
develop T(beta)4 for
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wound healing based on the patent application filed by the NIH, when and if a
patent is issued. The Company is presently negotiating with the NIH to secure
the NIH's rights under the patent application in order to effectively secure an
exclusive proprietary position with respect to T(beta)4 for wound healing,
should the patent be issued. No assurance can be given as to whether or when a
patent will be issued, or as to any conditions that might be attached to the
patent. In addition, no assurance can be given that the Company will be able to
successfully negotiate from the NIH an exclusive right to the patent issued, if
issued, under conditions acceptable to the Company. The animal studies conducted
to date by the NIH have indicated that T(beta)4 is effective in healing injured
tissue and improving wound healing and chemical burns in steroid-treated rodents
and other mammals.
In anticipation of Phase I clinical trials, the Company contracted with a
manufacturer to produce T(beta)4 for this, and future, studies of T(beta)4. In
March 2000, the Company pre-paid $50,000 of the $100,000 cost of an initial
quantity of the material and, under the agreement with the manufacturer, the
remaining $50,000 will become due 30 days after the Company's obtainment of
exclusive rights under the patent application filed by the NIH; however, if the
Company has not negotiated such exclusive rights by March 17, 2002, the
remaining amount will become due at that time.
For the Phase I clinical trials, it is expected that the T(beta)4 supplied by
the Company will be given to another manufacturer to produce a topical gel or
other material that will be administered to test subjects. Two manufacturers
have been identified to formulate and test this material. No agreements with
these manufacturers have been entered into, however, and no assurance can be
given that such agreements will be negotiated on terms favorable to the Company,
or at all. Before the Phase I clinical trials may begin, the Company must file
with the U.S. Food and Drug Administration (the "FDA") an Investigational New
Drug Application ("IND"), and the IND must be approved by the FDA. The Company
has received correspondence from the FDA which specifies the remaining
pre-clinical work the Company must undertake in order to have the IND approved.
The Company is currently evaluating the cost of completing the pre-clinical work
necessary for approval of the IND and Phase I clinical trials, and may need to
enter into a collaborative relationship with a larger partner or raise
additional funds to conduct these trials.
In following its product development strategy outlined above, the Company does
not plan to purchase manufacturing plants or other facilities and does not
expect any significant purchases of equipment. See "Liquidity and Capital
Resources" below.
FINANCIAL CONDITION
The Company's total assets at March 31, 2000 were $1,508,623, compared with
$932,363 at December 31, 1999. This increase was due to increases in the
Company's balance of cash and cash equivalents and the value of its remaining
investment in SciClone. Cash and cash equivalents increased to $542,356 at
March 31, 2000 from $43,387 at December 31, 1999, primarily as a result of
sales of SciClone common stock during the three-month period. The increase in
the Company's investment in SciClone, notwithstanding the sale of SciClone
shares, resulted from an increase in the market value of SciClone common stock
from December 31, 1999 to March 31, 2000.
The Company's total liabilities were reduced significantly to $273,644 at
March 31, 2000 from $1,327,362 at December 31, 1999. Accounts payable at March
31, 2000 were $71,700, compared with $273,385 at December 31, 1999, and
amounts owed under letter agreements with vendors
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totaled $164,823 at March 31, 2000 compared with $693,394 at December 31,
1999. These decreases resulted from the execution of settlement agreements
entered into with certain of the Company's creditors and other vendors and
repayment of amounts owed. Notes payable decreased to zero at March 31, 2000
from $301,722 at December 31, 1999, as a result of the payment by the Company
of $162,500 to SciClone in February 2000 in settlement of the amount owed at
year-end, plus interest.
Stockholders' equity (deficit) increased to $1,234,979 at March 31, 2000 from
($394,999) at December 31, 1999. This change resulted from settlement of
vendor payables and note payable, realized gains on the sale of SciClone
stock, and increases in accumulated other comprehensive income. The number of
outstanding shares of common stock rose from 11,977,429 to 19,477,429 as a
result of the issuance of 7,500,000 shares upon the exercise of stock options
granted to the Company's management consultants. The accumulated deficit fell
to ($35,725,154) at March 31, 2000 from ($37,005,591) at December 31, 1999 as
a result of the Company's net income of $1,280,437 for the three-month period
ended March 31, 2000.
RESULTS OF OPERATIONS
Net Income. The Company earned net income of $1,280,437 for the three-months
ended March 31, 2000 compared with a net loss of $377,355 for prior year
period. This change resulted primarily from a $1,011,927 increase in realized
gain (loss) on sale of investments and the inclusion in income for the three
months ended March 31, 2000 of extraordinary items totaling $747,028.
Excluding extraordinary items, the Company's net income for the three-months
ended March 31, 2000 was $533,409.
Operating Loss. The Company had an operating loss of $112,672 for the
three-months ended March 31, 2000 compared with an operating loss of $7,206
for the same period in 1999. This increase in operating losses resulted from
an increase in operating expenses for the first quarter of 2000, as discussed
below. Revenues for both the three months ended March 31, 2000 and the three
months ended March 31, 1999 were zero. As noted above, under "Plan of
Operation," the Company does not anticipate it will generate revenues in the
foreseeable future.
Operating expenses for the three-months ended March 31, 2000 totaled $112,672,
compared with $7,206 for the same period in 1999. This increase occurred
because the Company's operations were suspended during the three-months ended
March 31, 1999 and were resumed in August 1999, before the three-month period
ended March 31, 2000 began. Operating expenses were comprised of research and
development expenses, which were $53,839 for the three-months ended March 31,
2000 and zero for prior year period, and general and administrative expenses,
which were $58,833 for the three-months ended March 31, 2000 and $7,206 for
the prior year period. Research and development expenses during the first
quarter of 2000 primarily consisted of a $50,000 deposit paid toward the
purchase of T(beta)4 from a contract manufacturer to be used in clinical trials.
General and administrative expenses increased as a result of costs associated
with the Company's resumption of operations, including, among other things,
the payment of fees under the Company's management consultant agreement, legal
and accounting fees, and rent paid for the Company's leased office space.
Other Income (Loss) and Extraordinary Items. As a result of selling SciClone
shares, the Company realized a gain on sale of investments of $646,059 during
the three-months ended March 31, 2000, compared with a loss of $365,868 for
the prior year period. This change occurred because the market
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value of the SciClone shares was substantially higher at the time of the first
quarter 2000 sales. The Company had no interest expense during the first
quarter of 2000, compared with $4,281 of interest expense in the first quarter
of 1999. This change occurred as a result of the repayment of amounts owed to
certain of the Company's creditors. During the three-months ended March 31,
2000, the Company made payments and negotiated settlements of amounts owed to
certain vendors, reducing the aggregate amount owed to $164,823 on March 31,
2000 from $693,394 on December 31, 1999. The negotiation of these settlements
resulted in the reporting of an extraordinary item of $584,201 for the three
months ended March 31, 2000. During the first quarter of 2000, the Company
also negotiated a settlement of all amounts owed to SciClone under advances
made to the Company in connection with the royalty sale transaction. Prior to
payment of the $162,500 settlement amount, the Company owed SciClone $301,722.
The $162,827 difference between the amount owed and the settlement amount was
reported as an extraordinary item, resulting in an addition to income in that
amount.
LIQUIDITY AND CAPITAL RESOURCES
At March 31, 2000, the Company had cash and cash equivalents totaling $542,356
and working capital of $1,232,308 as compared to $43,387 and $(397,853),
respectively, at December 31, 1999. The increase in the Company's cash and
working capital positions from December 31, 1999 was due primarily to cash
generated by sales of SciClone shares in the first quarter of 2000, a
substantial increase in the market price of the SciClone common stock, which
increased the value of the Company's remaining investment in SciClone, and the
negotiation of agreements with creditors to accept discounts in return for
prompt cash payments. See also "Financial Condition."
The Company incurred no capital expenditures for equipment in the three-month
periods ended March 31, 2000 and 1999. The Company does not expect to spend
more than $15,000 in total for equipment in the year ending December 31, 2000.
The Company's only readily available sources of funds are its balance of cash
and cash equivalents and its ability to sell SciClone shares, the price of
which is subject to fluctuation and could decrease to a level that would
significantly limit the Company's ability to generate cash. As noted above
under "Plan of Operation," while no assurance can be given, the Company
believes that these sources will allow it to satisfy its cash requirements
through December 31, 2001. If the Company has not raised additional funds by
that date, or if the value of its Sciclone shares decline significantly, the
Company will likely be forced to again suspend or discontinue operations.
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ALPHA 1 BIOMEDICALS. INC.
PART II - OTHER INFORMATION
Item 1. Legal Proceedings
None
Item 2. Changes in Securities
On February 3, 2000, the Company issued an aggregate of 7,500,000 shares of
common stock upon the exercise of stock options granted pursuant to a
consulting agreement with Dr. Allan L. Goldstein, the Company's President and
Chief Executive Officer, J.J. Finkelstein, Richard J. Hindin and Sidney J.
Silver. The options, each of which had an exercise price of $0.04 per share,
were granted in August 1999 to Dr. Goldstein and Messrs. Finkelstein, Hindin
and Silver in consideration for their consulting services provided to the
Company (with each consultant receiving an option to purchase 1,875,000
shares). The Company accepted from each consultant as payment of the $75,000
exercise price a note payable to the Company in the amount of $75,000,
accruing interest at 6.09% per annum and payable quarterly for 36 months. The
notes are secured by the shares of Company common stock issued upon exercise
of the options.
The shares were issued by the Company in a private placement pursuant to
Section 4(2) of the Securities Act of 1933, as amended.
Item 6. Exhibits and Reports on Form 8-K
(a) Exhibits
(27) Financial Data Schedule.
(b) Reports on Form 8-K None
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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.
Alpha 1 Biomedicals, Inc.
-------------------------
(Registrant)
Date: November 8, 2000 /s/Allan L. Goldstein.
----------------------
Allan L. Goldstein
President and Chief Executive Officer
(Principal Executive Officer and
Principal Financial Officer)
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