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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
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For the quarterly period ended September 30, 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)
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<S> <C>
Delaware 52-1253406
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(State of Incorporation) (IRS Employer I.D. Number)
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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 SEPTEMBER 30, 2000
INDEX
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Part I. Financial Information Page No.
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Item 1. Financial Statements
Balance Sheets at September 30, 2000
(unaudited) and December 31, 1999 3
Statements of Operations for the three-months
and nine-months ended September 30, 2000 and
1999 (unaudited) 4
Statements of Cash Flows for the nine-months
ended September 30, 2000 and 1999 (unaudited) 5
Notes to Financial Statements (unaudited) 6-7
Item 2. Management's Discussion and Analysis or Plan of
Operations 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
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ITEM 1.
ALPHA 1 BIOMEDICALS, INC.
BALANCE SHEETS
<TABLE>
<CAPTION>
September 30, December 31,
2000 1999
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(unaudited)
ASSETS
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<S> <C> <C>
Current assets
Cash and cash equivalents $ 344,087 $ 43,387
Investment in SciClone 681,569 886,122
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Total current assets 1,025,656 929,509
Fixed assets, net 1,341 1,889
Due from related party, net of allowance 965 965
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Total assets $ 1,027,962 $ 932,363
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LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)
---------------------------------------------
Current liabilities
Accounts payable $ 55,593 $ 273,385
Accrued expenses 44,256 58,861
Notes payable - 301,722
Letter agreements with vendors 106,912 693,394
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Total current liabilities 206,761 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 (35,856,904) (37,005,591)
Accumulated other comprehensive income 550,839 483,326
Stock Subscription (300,000) -
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Total stockholders' equity (deficit) 821,201 (394,999)
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Total liabilities and stockholders' equity (deficit) $ 1,027,962 $ 932,363
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ALPHA 1 BIOMEDICALS, INC.
STATEMENTS OF OPERATIONS
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<CAPTION>
(Unaudited)
Three months ended Nine months ended
September 30, September 30,
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2000 1999 2000 1999
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<S> <C> <C> <C> <C>
Revenues $ - - $ - $ -
Expenses
Research and product development 12,288 - 80,562 -
General and administrative 85,996 - 211,843 7,206
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Total expenses 98,284 - 292,405 7,206
------------ ----------- ------------- ------------
Operating loss (98,284) - (292,405) (7,206)
Realized (loss) gain on sale of investments - (239,735) 646,059 (605,603)
Other income (expense), net 2,000 389 2,000 389
Interest expense - (3,881) - (8,162)
Interest income 5,279 18 11,258 18
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(Loss) income before extraordinary items (91,005) (243,209) 366,912 (620,564)
Extraordinary item - settlement of vendor payables - - 618,948 -
Extraordinary item - settlement of note payable - - 162,827 -
------------ ----------- ------------- ------------
Net (loss) Income $ (91,005) (243,209) $ 1,148,687 $ (620,564)
============ =========== ============= ============
Basic and diluted net (loss) income per common share
before extraordinary items $ (0.00) $ (0.02) $ 0.02 $ (0.05)
Extraordinary items - settlement of payables/debt - - 0.04 -
------------ ----------- ------------- ------------
Basic and diluted net (loss) income per common share $ (0.00) $ (0.02) $ 0.06 $ (0.05)
============ =========== ============= ============
Weighted average number of common shares outstanding 19,477,429 11,977,429 18,574,144 11,977,429
============ =========== ============= ============
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ALPHA 1 BIOMEDICALS, INC.
STATEMENTS OF CASH FLOWS
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<CAPTION>
(Unaudited)
Nine months ended
Septembeer 30,
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2000 1999
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Cash flows from operating activities:
Net Income (loss) $ 1,148,687 (620,564)
Adjustments to reconcile net loss to net
cash used in operating activities:
Depreciation 548 -
Realized (gain) loss on sale of investments (646,059) 605,603
Settlement of vendor payables (618,948) -
Settlement of note payable (139,222) -
Changes in operating assets and liabilities:
Decrease in due from related party - (1,180)
Decrease in accounts payable (185,326) (259,060)
Decrease in accrued expenses (14,605) (29,888)
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Net cash used in operating activities (454,925) (305,089)
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Cash flows from investing activities:
Cash received on sale of investments 918,125 389,148
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Net cash provided by investing activities 918,125 389,148
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Cash flows from financing activities:
Repayment of notes payable (162,500) (78,962)
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Net cash used in financing activities (162,500) (78,962)
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Net increase in cash and cash equivalents 300,700 5,097
Cash and cash equivlents at beginning of period 43,387 2,698
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Cash and cash equivalents at end of period $ 344,087 7,795
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ALPHA 1 BIOMEDICALS, INC.
NOTES TO FINANCIAL STATEMENTS
For the three-months and nine-months ended September 30, 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
insufficiency of 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 September 30, 2000, the Statements of Operations
for the three-month and nine-month periods ended September 30, 2000 and
1999, and the Statements of Cash Flows for the nine-month periods ended
September 30, 2000 and 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 September
30, 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 and nine-month periods ended
September 30, 2000 are not necessarily indicative of the operating
results anticipated for the full year.
C. NET (LOSS) INCOME PER SHARE
Unexercised stock options and warrants were not included in the
computations of diluted net income (loss) per share because the exercise
prices of such options and warrants were greater than the average market
price of the Company's common stock during the period. In addition, since
the Company had net losses during the three months ended September 30,
1999 and 2000 and the nine months ended September 30, 1999, no potential
common shares to be issued were included in the computation of the diluted
per share amount for those periods as they would be antidilutive.
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
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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,
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 September 30, 2000, the Company's current assets
consisted of a balance of cash and cash equivalents of $344,087 and 62,673
shares of the common stock of SciClone Pharmaceuticals, Inc. ("SciClone"),
valued at approximately $681,569, 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
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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 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 September 30, 2000 were $1,027,962, 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 share price of its
remaining investment in SciClone. Cash and cash equivalents increased to
$344,087 at September 30, 2000 from $43,387 at December 31, 1999, primarily as
a result of sales of SciClone common stock during the first three-months of
the year. The decrease in the Company's investment in SciClone resulted from
the sale of SciClone shares in the first quarter of 2000 offset by an increase
in the market value of SciClone common stock.
The Company's total liabilities were reduced significantly to $206,761 at
September 30, 2000 from
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$1,327,362 at December 31, 1999. Accounts payable at September 30, 2000 were
$55,593, compared with $273,385 at December 31, 1999, and amounts owed under
letter agreements with vendors totaled $106,912 at September 30, 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 $0 at September 30, 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 $821,201 at September 30, 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 to 19,477,429 at September 30, 2000
from 11,977,429 at December 31, 1999 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 ($35,856,904) at September 30,
2000 from ($37,005,591) at December 31, 1999 as a result of the Company's net
income of $1,148,687 for the nine-month period ended September 30, 2000.
RESULTS OF OPERATIONS
Net Income. The Company had a net loss of $91,005 and net income of $1,148,687
for the three-month and nine-month periods ended September 30, 2000,
respectively, compared with a net loss of $243,209 and $620,564 for prior year
periods, respectively. The change in the three-month periods resulted
primarily from a realized loss on the sale of investments in the three-months
ended September 30, 1999. The change in the nine-month periods resulted
primarily from a realized gain on the sale of investments in the nine-months
ended September 30, 2000 compared to a realized loss on the sale of
investments in the nine-months ended September 30, 1999, and the inclusion of
extraordinary items totaling $781,775 in income for the nine-months ended
September 30, 2000. Excluding extraordinary items, the Company's net loss for
the three-months ended September 30, 2000 was $91,005 and net income for the
nine-months ended September 30, 2000 was $366,912.
Operating Loss. The Company had an operating loss of $98,284 and $292,405 for
the three-months and nine-months ended September 30, 2000, respectively,
compared with an operating loss of $0 and $7,206 for the same periods in 1999,
respectively. This increase in operating losses resulted from an increase in
operating expenses during the nine-months of 2000, as discussed below.
Revenues for the three-months and nine-months ended September 30, 2000 and
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 and nine-months ended September 30,
2000 totaled $98,284 and $292,405, respectively, compared with $0 and $7,206
for the same periods in 1999, respectively. This increase occurred because the
Company's operations were suspended for most of the nine-months ended
September 30, 1999 and were resumed in August 1999, before the nine-month
period ended September 30, 2000 began. Operating expenses were comprised of
research and development expenses, which were $12,288 and $80,562 for the
three-months and nine-months ended September 30, 2000, respectively, and $0
for prior year periods, and general and administrative expenses, which were
$85,996 and $211,843 for the three-months and nine-months ended
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September 30, 2000, respectively, and $0 and $7,206 for the prior year
periods, respectively. Research and development expenses during the first
nine-months of 2000 primarily consisted of a $50,000 deposit paid toward the
purchase of Ta4 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 in the first quarter of 2000, the Company realized a gain on sale of
investments of $646,059 during the nine-months ended September 30, 2000,
compared with a loss of $605,603 for the nine-months ended September 30, 1999
and $0 for the three-months ended September 30, 1999. This change occurred
because the market value of the SciClone shares was substantially higher at
the time of the sales in 2000. The Company had no interest expense during the
first nine-months of 2000, compared with $3,881 and $8,162 of interest expense
in the three-month and nine-month periods ended September 30, 2000,
respectively. This change occurred as a result of the repayment of amounts
owed to certain of the Company's creditors. During the nine-months ended
September 30, 2000, the Company made payments and negotiated settlements of
amounts owed to certain vendors, reducing the aggregate amount owed to
$106,912 on September 30, 2000 from $693,394 on December 31, 1999. The
negotiation of these settlements resulted in the reporting of extraordinary
items of $0 and $618,948 for the three- and nine-months ended September 30,
2000, respectively. 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 for the nine-months ended September 30, 2000.
LIQUIDITY AND CAPITAL RESOURCES
At September 30, 2000, the Company had cash and cash equivalents totaling
$344,087 and working capital of $818,895 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 nine-month
periods ended September 30, 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
None
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 14, 2000 /s/Allan L. Goldstein.
----------------------
Allan L. Goldstein
President and Chief Executive Officer
(Principal Executive Officer and
Principal Financial Officer)
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