Securities and Exchange Commission
Washington, D.C. 20549
(Mark One)
|X| QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934 for the quarterly period ended June 30, 1999.
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 001-14907
IMMTECH INTERNATIONAL, INC.
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(Name of Small Business as specified in its Charter)
Delaware 39-1523370
- --------------------------------- ------------------------
(State or other jurisdiction of (I. R. S. Employer
incorporation or organization) Identification No.)
1890 Maple Avenue, Suite 110, Evanston, Illinois 60201
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(Address of principal executive offices) (Zip Code)
Issuer's telephone number: (847) 869-0033
Securities registered under Section 12 (b) of the Exchange Act:
Title of Each Class Name of Each Exchange
in which Registered
- ------------------------------------ -------------------------------
Common Stock, $.01 per share Boston Stock Exchange
Securities registered under Section 12(g) of the Exchange Act: None
Check whether the issuer: (1) has filed all reports required to be filed
by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the 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 |X| No |_|
As of July 30, 1999, 5,139,453 shares of the Registrant's Common Stock
were Outstanding.
Transitional Small Business Disclosure Format: (Check One): Yes |_| No |X|
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PART I.
Item 1. Financial Statements
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<PAGE>
IMMTECH INTERNATIONAL, INC.
(A Development Stage Enterprise)
CONDENSED BALANCE SHEETS
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June 30, March 31,
ASSETS 1999 1999
CURRENT ASSETS:
Cash and cash equivalents $ 8,525,242
Prepaid expenses and supplies 15,864 $ 8,364
------------ ------------
Total current assets 8,541,106 8,364
------------ ------------
PROPERTY AND EQUIPMENT:
Furniture and equipment 341,168 296,042
Leasehold improvements 17,205 17,205
------------ ------------
Total - at cost 358,373 313,247
Less accumulated depreciation
and amortization 290,010 283,230
------------ ------------
Property and equipment - net 68,363 30,017
DEFERRED OFFERING COSTS 513,210
------------ ------------
TOTAL $ 8,609,469 $ 551,591
============ ============
LIABILITIES AND COMMON STOCKHOLDERS'
INVESTMENT (DEFICIENCY IN ASSETS)
CURRENT LIABILITIES:
Accounts payable $ 219,620 $ 508,232
Accrued interest 281,470
Other accrued liabilities 33,872 50,351
Advances from stockholders
and affiliates 50,000
Notes payable 110,000
------------ ------------
Total current liabilities 253,492 1,000,053
------------ ------------
COMMON STOCKHOLDERS' INVESTMENT
(DEFICIENCY IN ASSETS)
Preferred stock
Common stock 51,346 32,455
Additional paid-in capital 26,676,764 10,997,198
Deficit accumulated during the
developmental stage (18,372,133) (11,478,115)
------------ ------------
Total common stockholders'
investment (deficiency in
assets) 8,355,977 (448,462)
------------ ------------
TOTAL $ 8,609,469 $ 551,591
============ ============
See notes to condensed financial statements.
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IMMTECH INTERNATIONAL, INC.
(A Development Stage Enterprise)
CONDENSED STATEMENTS OF OPERATIONS
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<TABLE>
<CAPTION>
October 15,
Three Months Ended 1984
June 30, (Inception)
---------------------------- to June 30,
1999 1998 1999
<S> <C> <C> <C>
REVENUES $ 5,788 $ 136,909 $ 1,993,861
------------ ------------ ------------
EXPENSES:
Research and development 6,614,714 310,499 14,207,921
General and administrative 350,138 117,621 8,398,757
Cancelled offering costs 584,707
------------ ------------ ------------
Total expenses 6,964,852 428,120 23,191,385
------------ ------------ ------------
LOSS FROM OPERATIONS (6,959,064) (291,211) (21,197,524)
------------ ------------ ------------
OTHER INCOME (EXPENSE):
Interest expense (53,800) (1,129,502)
Interest income 64,842 70,522
Miscellaneous income (expense) - net 204 1,123 86,707
------------ ------------ ------------
Other income (expense) - net 65,046 (52,677) (972,273)
------------ ------------ ------------
LOSS BEFORE EXTRAORDINARY ITEM (6,894,018) (343,888) (22,169,797)
EXTRAORDINARY GAIN ON EXTINGUISHMENT
OF DEBT 1,427,765
------------ ------------ ------------
NET LOSS (6,894,018) (343,888) (20,742,032)
CONVERSION OF REDEEMABLE PREFERRED STOCK 3,713,334
REDEEMABLE PREFERRED STOCK PREMIUM
AMORTIZATION 440,119
REDEEMABLE PREFERRED STOCK DIVIDENDS (108,502) (1,783,554)
------------ ------------ ------------
NET LOSS ATTRIBUTABLE TO COMMON
STOCKHOLDERS $ (6,894,018) $ (452,390) $(18,372,133)
============ ============ ============
NET LOSS PER SHARE ATTRIBUTABLE TO
COMMON STOCKHOLDERS:
Net loss $ (1.54) $ (0.46)
Redeemable preferred stock dividends (0.15)
------------ ------------
NET LOSS PER SHARE ATTRIBUTABLE TO
COMMON STOCKHOLDERS $ (1.54) $ (0.61)
============ ============
SHARES USED IN COMPUTING NET LOSS
PER SHARE ATTRIBUTABLE TO COMMON
STOCKHOLDERS 4,464,313 743,715
============ ============
</TABLE>
See notes to condensed financial statements.
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IMMTECH INTERNATIONAL, INC.
(A Development Stage Enterprise)
CONDENSED STATEMENTS OF CASH FLOWS
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<TABLE>
<CAPTION>
October 15,
Three Months Ended 1984
June 30, (Inception)
---------------------------- to June 30,
1999 1998 1999
<S> <C> <C> <C>
OPERATING ACTIVITIES:
Net loss $ (6,894,018) $ (343,888) $(20,742,032)
Adjustments to reconcile net loss
to net cash (used in) provided
by operating activities:
Depreciation and amortization of
property and equipment 6,780 6,780 321,690
Amortization of debt discount and
issuance costs 134,503
Compensation recorded related to
issuance of common stock or
common stock options 6,216,277 23,667 11,105,240
Extraordinary gain on extinguishment
of debt (1,427,765)
Changes in operating assets and
liabilities:
Prepaid expenses and supplies (7,500) (2,496) (15,864)
Accounts payable (288,612) (28,944) 219,620
Other accrued liabilities (16,479) 423,211 33,872
Accrued interest 53,463 663,013
------------ ------------ ------------
Net cash (used in) provided by
operating activities (983,552) 131,793 (9,707,723)
------------ ------------ ------------
INVESTING ACTIVITIES - Purchases
of property and equipment (45,126) (363,529)
------------ ------------ ------------
FINANCING ACTIVITIES:
(Repayments of) advances from
stockholders and affiliates (50,000) 985,172
Proceeds from the issuance of
senior subordinated debt 525,000
Proceeds from the issuance
of notes payable 2,120,194
Payments on notes payable (110,000) (3,500) (218,119)
Payments for debt issuance costs (53,669)
Payments for extinguishment of debt (203,450)
Proceeds from the issuance of
Preferred Stock - Series A 1,330,000
Proceeds from the issuance of
Preferred Stock - Series B 2,000,000
Proceeds from the issuance of
common stock 9,713,920 11,879,632
Additional capital contributed
by stockholders 231,734
Payments for offering costs deferred (60,511)
------------ ------------ ------------
Cash provided by (used in)
financing activities 9,553,920 (64,011) 18,596,494
------------ ------------ ------------
NET INCREASE IN CASH AND CASH EQUIVALENTS 8,525,242 67,782 8,525,242
CASH AND CASH EQUIVALENTS,
BEGINNING OF PERIOD 0 0 0
------------ ------------ ------------
CASH AND CASH EQUIVALENTS, END OF PERIOD $ 8,525,242 $ 67,782 $ 8,525,242
============ ============ ============
</TABLE>
See notes to condensed financial statements.
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<PAGE>
IMMTECH INTERNATIONAL, INC.
(A Development Stage Enterprise)
NOTES TO CONDENSED FINANCIAL STATEMENTS
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1. BASIS OF PRESENTATION
The accompanying condensed financial statements have been prepared by
Immtech International, Inc. (the "Company") pursuant to the rules and
regulations of the Securities and Exchange Commission ("SEC") and, in the
opinion of the Company, include all adjustments necessary for a fair
statement of results for each period shown. Certain information and
footnote disclosures normally included in financial statements prepared in
accordance with generally accepted accounting principles have been
condensed or omitted pursuant to such SEC rules and regulations. The
Company believes that the disclosures made are adequate to prevent the
financial information given from being misleading. It is suggested that
these financial statements be read in conjunction with the financial
statements and notes thereto included in the Company's previously filed
Form 10-KSB.
2. COMPANY BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Description of Business - The Company is a biopharmaceutical company
focusing on the discovery and development of therapeutic products for the
treatment of opportunistic diseases and cancer in patients with
compromised immune responses. The Company has two separate platform
technologies for developing drugs, one based on developing a new class of
molecules as pharmaceuticals and a second for developing a series of
biological proteins that work in conjunction with the immune system.
The Company was incorporated in 1984. The Company is in the development
stage and has directed its efforts toward research and development, hiring
scientific and management personnel, arranging for facilities and
conducting clinical trials. The Company has no products currently
available for sale, and none are expected to be commercially available for
several years.
Risks and Uncertainties - Since inception, the Company has incurred
accumulated losses of approximately $18,372,000. Management of the Company
expects the Company to continue to incur significant losses during the
next several years as the Company expands its research and development
activities and clinical trial efforts. In addition, the Company has
various research and development agreements with various entities that are
thinly capitalized and are dependent upon their ability to raise
additional funds to continue their research and development activities.
The Company does not have any therapeutic products currently available for
sale, and none are expected to be commercially available for several
years, if at all. There can be no assurance that the Company's continued
research will lead to the development of commercially viable products. The
Company's operations to date have consumed substantial amounts of cash.
The negative cash flow from operations is expected to continue and to
accelerate in the foreseeable future. The Company will require substantial
funds to conduct research and development, preclinical and clinical
testing and to manufacture (or have manufactured) and market (or have
marketed) its product candidates.
The Company's ability to continue as a going concern is dependent upon its
ability to generate sufficient funds to meet its obligations as they
become due and ultimately, to obtain profitable operations. On April 30,
1999, the Company completed an initial public offering which raised
approximately $9,173,000 of
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additional equity capital. The net proceeds from the initial public
offering are not sufficient to fund the Company's operations through the
commercialization of one or more products yielding sufficient revenues to
support the Company's operations; therefore, the Company will need to
raise additional funds. Management's plans for the forthcoming year
include continuing their efforts to obtain additional equity financing and
research grants, and enter into various research and development
agreements with other entities.
Cash Equivalents - The Company considers all investments with purchased
maturities of less than three months to be cash equivalents. Cash
equivalents consist of overnight time deposits.
Property and Equipment - Equipment and leasehold improvements are recorded
at cost and depreciation and amortization are provided using accelerated
methods. Assets are depreciated over five to seven years.
Deferred Offering Costs - Costs incurred with respect to a common stock
offering in process as of March 31, 1999 were deferred pending the
completion of the offering. As of March 31, 1999, there were approximately
$329,000 of deferred offering costs that were unpaid and included in
accounts payable. The offering was completed on April 30, 1999 and the
costs were netted with the proceeds of the offering.
Revenue Recognition - Revenue under grants and research and development
agreements is recognized based on the Company's estimates of the stage of
completion under the terms of the respective agreements.
Research and Development Costs - All research and development costs are
charged to operations as incurred.
Income Taxes - The Company accounts for income taxes using an asset and
liability approach. Deferred income tax assets and liabilities are
computed annually for differences between the financial statement and tax
bases of assets and liabilities that will result in taxable or deductible
amounts in the future based on enacted tax laws and rates applicable to
the periods in which the differences are expected to affect taxable
income.
Net (Loss) Income Per Share - Net (loss) income per share is calculated in
accordance with Statement of Financial Accounting Standards ("SFAS") No.
128, "Earnings Per Share." Diluted net (loss) income per share was the
same as the basic net (loss) income per share as the stock options and
warrants were antidilutive for the three months ended June 30, 1999 and
1998.
Segment Reporting - The Company is a development stage biopharmaceutical
company that operates as one segment.
Comprehensive Income (Loss) - There is no difference between comprehensive
income (loss) and net income (loss) for the three months ended June 30,
1999 and 1998.
Use of Estimates - The preparation of financial statements in conformity
with generally accepted accounting principles requires management to make
estimates and assumptions that affect the reported amounts of assets and
liabilities and disclosure of contingent assets and liabilities at the
date of the financial statements and the reported amounts of revenues and
expenses during the reporting period. Actual results could differ from
those estimates.
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Approved Accounting Standard Not Adopted - In 1998, the Financial
Accounting Standards Board issued Statement of Financial Accounting
Standards ("SFAS") No. 133, "Accounting for Derivative Instruments and
Hedging Activities." The Company is in the process of evaluating the
accounting and reporting requirements of SFAS No. 133 and does not believe
the adoption of SFAS No. 133 will have a significant effect on the
Company's financial statements.
3. RECAPITALIZATION, PRIVATE PLACEMENT, STOCK SPLITS AND INITIAL PUBLIC
OFFERING
On July 24, 1998 (the "Effective Date"), the Company (with stockholder
approval) completed a recapitalization (the "Recapitalization) pursuant to
which: (i) the Company effected a .645260-for-1 reverse stock split of all
of the shares of common stock issued and outstanding immediately prior to
the Effective Date, resulting in the reduction in the number of issued and
outstanding shares of common stock from 2,305,166 to 1,487,431 (the "First
Reverse Stock Split"); (ii) the Company's debtholders converted
approximately $3,151,000 in stockholder advances, notes payable and
related accrued interest and accounts payable outstanding immediately
prior to the Effective Date into 1,209,962 shares of common stock (after
giving effect to the First Reverse Stock Split) and approximately $203,000
in cash; (iii) the Company's Series A Preferred stockholders converted
1,794,550 shares of Series A Preferred Stock issued and outstanding
immediately prior to the Effective Date into 1,157,931 shares of common
stock (after giving effect to the First Reverse Stock Split); (iv) the
Company's Series B Preferred stockholders converted 1,600,000 shares of
Series B Preferred Stock issued and outstanding immediately prior to the
Effective Date into 1,232,133 shares of common stock (after giving effect
to the First Reverse Stock Split); (v) the Company converted options
outstanding immediately prior to the Effective Date and held by employees
of or consultants to the Company to purchase an aggregate of 1,746,815
shares of common stock into options to purchase 1,127,150 shares of common
stock (after giving effect to the First Reverse Stock Split); and (vi) the
total number of authorized shares was increased to 35,000,000, consisting
of 30,000,000 shares of common stock, $.01 par value, and 5,000,000 shares
of preferred stock, $.01 par value.
On January 25, 1999, the Company effected a .5-for-1 reverse stock split
of all of the shares of common stock issued and outstanding as of February
5, 1999, resulting in a reduction in the number of issued and outstanding
shares from 6,491,135 to 3,245,517 (the "Second Reverse Stock Split") as
of December 31, 1998.
All other share and per share information included in the accompanying
financial statements has been restated to reflect the First Reverse Stock
Split and the Second Reverse Stock Split.
Contemporaneously with the completion of the Recapitalization, the Company
issued and sold 575,000 shares of common stock for $1.74 per share, or
aggregate consideration to the Company of $1,000,000 to certain accredited
investors. For services and expenses involved with this Recapitalization,
the placement agent New China Hong Kong Securities Limited ("NCHK")
received $50,000 and warrants to purchase 75,000 shares of the Company's
common stock at $.10 per share. On May 17, 1999, NCHK exercised their
warrants. For advisory services in this transaction, RADE Management
Corporation ("RADE") received warrants to purchase 225,000 shares of the
Company's common stock at $.10 per share. On April 22, 1999, the warrant
agreement with RADE was amended to increase the exercise price from $.10
per share to $6.47 per share. The warrants expire July 29, 2004.
On April 30, 1999, the Company issued 1,150,000 shares of common stock
through an initial public stock offering resulting in net proceeds of
approximately $9,173,000. The underwriters received
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warrants to purchase 100,000 additional shares of common stock at $16.00
per share. The warrants expire April 30, 2003.
4. ADVANCES FROM STOCKHOLDERS AND AFFILIATES
Criticare Systems, Inc. ("Criticare"), a significant stockholder of the
Company, who, as of March 31, 1998, owned 1,000,000 shares of Series A
Preferred Stock, 1,200,000 shares of Series B Preferred Stock and 112,501
shares of common stock, had advanced $597,722 to the Company as of March
31, 1998. Interest on the advances accrued at a rate of 5%. The advances
were payable on demand. On July 24, 1998, Criticare exchanged $597,722 of
advances and $68,368 of accrued interest for 145,353 shares of common
stock. The carrying value of the outstanding Criticare indebtedness under
the advances in excess of the estimated fair value of the shares of common
stock and cash exchanged was accounted for as additional paid-in capital.
As of July 24, 1998, Criticare owned 1,087,939 shares (approximately 34%)
of the Company's outstanding common stock.
Certain other stockholders had advanced funds to the Company aggregating
$387,450 as of March 31, 1998. The advances were non-interest bearing and
payable on demand. On July 24, 1998, the other shareholders exchanged
$387,450 of advances for 196,824 shares of common stock. The Company
recognized an extraordinary gain on the extinguishment of debt of $80,404
for the outstanding indebtedness under the advances in excess of the
estimated fair value of the 196,824 shares of common stock ($307,046)
during the three months ended September 30, 1998. As of July 24, 1998,
none of the other stockholders individually owned more than approximately
8% of the Company's outstanding common stock.
As of March 31, 1999, NextEra Therapeutics, Inc. ("NextEra"), an
affiliate, and the Company's president had each advanced $25,000 to the
Company. The advances were non-interest bearing and were repaid in May
1999.
5. NOTES PAYABLE
Notes payable consisted of the following as of March 31, 1999:
State of Illinois, payment made in May 1999
upon closure of initial public offering,
0% interest, unsecured $100,000
Northwestern University, payment made in
May 1999, 0% interest, unsecured 10,000
--------
Total notes payable $110,000
========
Interest on the State of Illinois loan stopped accruing during the year
ended March 31, 1996, when the maximum interest of $281,470 from this loan
was reached. The accrued interest obligation was settled with the issuance
of 28,147 shares of common stock in May 1999. The interest rate on this
loan was 25% prior to when it stopped accruing interest. Interest on the
Northwestern University loan stopped accruing during the year ended March
31, 1997, when this loan was restructured to provide Northwestern
University with higher monthly payments in exchange for no further
interest accrual.
On July 24, 1998, certain notes payable to Criticare aggregating $89,777
and related accrued interest of $27,201 were exchanged for 25,526 shares
of common stock. The carrying value of the outstanding
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Criticare indebtedness such notes in excess of the estimated fair value of
the shares of common stock exchanged was accounted for as additional
paid-in capital, as Criticare is a significant stockholder.
On July 24, 1998, certain notes payable aggregating $1,365,673, related
accrued interest aggregating $353,515 and accounts payable aggregating
$261,597 were exchanged for 247,734 shares of common stock and $203,450
cash. During the three months ended September 30, 1998, the Company
recognized an extraordinary gain on the extinguishment of debt of
$1,347,361 for the outstanding aggregate indebtedness under such notes
($1,306,673), related accrued interest ($337,290) and accounts payable
($261,597) in excess of the estimated fair value of the shares of common
stock ($354,749) and cash ($203,450) exchanged. As of July 24, 1998, none
of these debt holders individually owned more than approximately 8% of the
Company's outstanding common stock.
6. REDEEMABLE PREFERRED STOCK
On July 24, 1998, Series A and B Preferred stockholders exchanged their
preferred shares for an aggregate 1,195,017 shares of common stock. The
holders of the Series A and Series B Preferred Stock had cumulative
dividend preferences at the rate of 8% per annum, compounded daily, of the
liquidation value thereof, plus accumulated and unpaid dividends thereon,
in preference to any dividend on common stock, payable when and if
declared by the Board of Directors. Dividends accrued whether or not they
had been declared and whether or not there were profits, surplus or other
funds of the Company legally available for the payment of dividends.
The difference between the initial estimated fair value of the Series A
Preferred Stock and the aggregate redemption value was amortized by a
credit to retained earnings (deficit accumulated during the developmental
stage) and a debit to the carrying value of the redeemable preferred stock
during the period from issuance to December 21, 1997 using the interest
method.
The Series A and Series B Preferred Stock had redemption (carrying) values
of $2,780,324 and $2,797,260, respectively, as of July 24, 1998. In
connection with the Recapitalization, the Series A and Series B Preferred
stockholders agreed to accept 578,954 and 616,063 shares of common stock,
respectively, for their shares of the preferred stock. The difference
between the carrying value of the Series A and Series B Preferred Stock
and the estimated fair value of the common shares exchanged of $1,877,138
and $1,836,196, respectively, was credited to deficit accumulated during
the development stage during the three months ended September 30, 1998.
7. STOCK OPTIONS, WARRANTS AND COMMON STOCK
The Company had 5,134,614 shares and 3,245,517 shares of common stock
outstanding as of June 30, 1999 and March 31, 1999, respectively.
The Company has granted common stock options to individuals who have
contributed to the Company. The options contain various provisions
regarding vesting periods, expiration dates, stockholder approval
requirements and contingencies on the approval of an increase in the stock
option pool by the Board of Directors. The options vest in periods ranging
from 0 to 4 years and generally expire in ten years. As of June 30, 1999
there were options outstanding to purchase 495,868 shares of common stock.
As of June 30, 1999, there were 2,581 employee stock options available for
grant.
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During the three months ended June 30, 1999, the Company issued 2,176
stock options to nonemployees for services rendered to the Company, and
recorded expense of approximately $37,000 for these options. The expense
was determined based on the estimated fair value of the options issued.
The activity during the three months ended June 30, 1999 for the Company's
stock options is summarized as follows:
Weighted
Number of Stock Options Average
Shares Price Range Exercise Price
Outstanding at April 1, 1999 516,992 $0.31-2.70 $ 0.64
Granted 2,176 0.59 0.59
Exercised 23,300 0.34-.59 0.59
------- ---------- ------
Outstanding at June 30, 1999 495,868 0.31-2.70 0.64
======= ========== ======
Exercisable at June 30, 1999 429,326 $0.31-2.70 $ 0.67
======= ========== ======
On October 12, 1998, RADE received warrants to purchase 750,000 shares of
the Company's common stock at $.10 per share. On April 22, 1999, the
warrant agreement was amended to increase the exercise price from $.10 per
share to $6.47 per share. The warrants were issued as compensation for
management consulting, market analysis and strategic advisory services
performed during July through December 1998. The Company recognized
$1,110,000 as a general and administrative expense during each of the
three month periods ended September 30, 1998 and December 31, 1998, based
upon the estimated fair value of the warrants issued. The warrants expire
October 12, 2004.
The following table summarizes information about common stock warrants
outstanding as of June 30, 1999 after giving affect to the April 22, 1999
amendments to certain warrant agreements:
Warrants
Exercise Price Outstanding Expiration Date
$5.00 per share 90,000 August 29, 1999
$6.47 per share (as amended on April 22, 1999) 225,000 July 29, 2004
$6.47 per share 750,000 October 12, 2004
$16.00 per share 100,000 April 30, 2003
$20.52 per share 850,000 April 30, 2009
---------
Total warrants outstanding 2,015,000
=========
The Company has adopted the disclosure-only provisions of Statement of
Financial Accounting Standards No. 123 ("SFAS No. 123"), "Accounting for
Stock-Based Compensation," but applies Accounting Principles Board Opinion
No. 25 and related interpretations in accounting for its employee stock
option plans. There were no common stock options issued to employees
during the three months ended June 30, 1999 and 1998.
8. COLLABORATIVE RESEARCH AND DEVELOPMENT ACTIVITIES
The Company has various collaborative research agreements with commercial
enterprises. Under the terms of these arrangements, the Company has agreed
to perform best efforts research and development
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and, in exchange, the Company may receive advanced cash funding and may
also earn additional fees for the attainment of certain milestones. The
Company may receive royalties on the sales of such products. The other
parties generally receive exclusive marketing and distribution rights for
certain products for set time periods in specific geographic areas.
The Company initially acquired its rights to the platform technology and
dicationic compounds developed by a consortium of universities including
The University of North Carolina at Chapel Hill ("UNC"), Duke University,
Auburn University and Georgia State University (the "Consortium") pursuant
to an agreement, dated January 15, 1997 (as amended in May 1998, the
"Consortium Agreement") among the Consortium, Pharm-Eco Laboratories, Inc.
("Pharm-Eco"), and on behalf of itself and the other academic institutions
in the Consortium. The Consortium Agreement commits each party to the
agreement to research, develop, finance the research and development of,
manufacture and market the technology and compounds owned by the
Consortium and then licensed or optioned to Pharm-Eco (the "Current
Compounds") and licensed to the Company pursuant to the Consortium
Agreement, and all technology and compounds developed by the Consortium
after the date thereof through use of Company-sponsored research funding
or National Cooperative Drug Development grant funding made available to
the Consortium (the "Future Compounds" and, collectively with the Current
Compounds, the "Compounds"). The Consortium Agreement contemplates that
the Company and Pharm-Eco, with respect to the Current Compounds, and the
Company and UNC, with respect to Future Compounds, will enter into more
comprehensive license or assignments of the intellectual property rights
held by Pharm-Eco and the Consortium; and that Pharm-Eco and the Company
will enter into an arrangement relating to the manufacture of products
derived from the Compounds.
Under the Consortium Agreement, the Company agreed to use its best efforts
to complete an initial public offering ("IPO") of shares of its common
stock with gross proceeds of at least $10,000,000 or an alternative form
of financing ("Alternative Financing") to raise at least $4,000,000 by
April 30, 1999. As a result of the closing of the IPO, the Company will:
(i) use $5,000,000, to develop the Compounds; (ii) issue an aggregate of
611,250 shares of common stock to Pharm-Eco or persons designated by
Pharm-Eco, which number includes 137,500 shares to be issued to the
Consortium; the Company has recorded $6,112,500 research and development
costs based on the estimated fair value of the 611,250 shares issued
during the three months ended June 30, 1999; (iii) issue warrants to
purchase an aggregate of 850,000 shares of common stock to Pharm-Eco or
persons designated by Pharm-Eco with a ten-year term from the date of
issuance, at an exercise price equal to the weighted average market price
of the Company's common stock during the first 20 days of trading on the
over-the-counter market ($20.52 per share), which warrants are exercisable
upon the occurrence of certain events and subject to redemption by the
Company; and (iv) agree to issue an aggregate of 150,000 shares of common
stock collectively to Pharm-Eco or persons designated by Pharm-Eco, which
number of shares includes 100,000 shares of common stock to be issued to
the Consortium, upon the filing by the Company of a new drug application
or an abbreviated new drug application with the Food and Drug
Administration with respect to any product. In addition, the Company will
pay UNC an aggregate royalty of 5% of net sales of current products and
future products, except that the royalty rate payable on any Compound
developed at Duke University will be determined by negotiation at the time
such Compound is developed. In the event that the Company sublicenses its
rights with respect to the Compounds, the Company will pay UNC, in
addition to the royalty described above, 2.5% of all signing, milestone
and other non-royalty payments made to the Company pursuant to the
sublicense agreement and will pay to Pharm-Eco 2.5% of all signing,
milestone and other nonroyalty payments made to the Company pursuant to
the sublicense agreement.
-12-
<PAGE>
As a result of the April 30, 1999 IPO: (a) Pharm-Eco is entitled to
designate for appointment one representative to the Company's Board of
Directors, (b) UNC is entitled to designate one person as a non-voting
observer of all meetings and other proceedings of the Company's Board of
Directors, (c) the Company is required to make quarterly $100,000 research
grants to UNC commencing on the final day of the month during which the
closing of the offering occurs, and continuing every three months
thereafter until, at a minimum, the third anniversary of the offering and
(d) the Company will pay all costs to prosecute, maintain and defend all
patents and patent applications relating to any Compounds or products.
Since the gross proceeds of the April 30, 1999 initial public offering
were more than $10,000,000, both Pharm-Eco and UNC will grant an exclusive
worldwide license to use, manufacture, have manufactured, promote, sell,
distribute, or otherwise dispose of any products based directly or
indirectly on all of the Current Compounds and Future Compounds.
During the three months ended June 30, 1999 and 1998, the Company expensed
payments to UNC of $350,000 and $200,000, respectively. Such payments were
expensed as research and development costs.
The Company has entered into an agreement with Pharm-Eco to use reasonable
efforts to form a joint venture to produce Good Manufacturing
Practices-quality dicationic drugs and products for clinical testing and
for early commercialization. The proposed joint venture would manufacture
the initial pharmaceutical products (DAP-092 and DB-289). Once the
commercial sale of products begins, the Company and Pharm-Eco would deduct
their costs associated with making and marketing (including selling,
marketing, and regulatory support) products. The remaining margin, after
the costs have been subtracted, would be divided equally between the
parties. At such time when the Company's sales reach $20 million for
DAP-092 and DB-289, the Company could elect not to use Pharm-Eco for
manufacturing, whereupon the Company would be required to pay a royalty to
Pharm-Eco of no more than 2% of sales.
* * * * * *
-13-
<PAGE>
Item 2. Management's Discussion and Analysis of Financial Condition and Results
of Operations.
OVERVIEW
Immtech International, Inc. ("Immtech" or the "Company") is a
biopharmaceutical company focused on the discovery and commercialization of
therapeutics for the treatment of patients afflicted with opportunistic
infectious diseases, cancer or compromised immune systems. The Company has two
independent programs for developing drugs. The first is based on a technology
for the design of a new class of pharmaceutical compounds commonly referred to
as dications. The Company believes that pharmaceutical dications can be designed
to inhibit the growth of a wide variety of infectious organisms which cause
fungal, protozoan parasitic, bacterial and viral diseases. The second is based
on biological proteins that work in conjunction with the body's immune system.
These biological proteins are derivatives of C-Reactive Protein ("CRP"), which
occurs naturally in the body and which the Company believes can be used to
control the structural environment around cancerous tumors and to reprogram
cancerous cells to stop growing uncontrollably and revert to normal cell
behavior.
With the exception of research agreements and past development funding
from Centocor, Sigma-Aldrich and certain research grants, the Company has not
generated any revenue from operations. For the period from inception to June 30,
1999, the Company incurred a cumulative net loss of $18,372,133. The Company has
incurred additional losses since such date and expects to incur additional
operating losses for the foreseeable future. The Company expects that its
revenue sources for at least the next several years will be limited to research
grants from Small Business Technology Transfer Program Grants ("STTR") and
payments from other collaborators under arrangements that my be entered into in
the future. The timing and amounts of such revenues, if any, will likely
fluctuate sharply and depend upon the achievement of specified milestones, and
results of operations for any period may be unrelated to the results of
operations for any other period.
RESULTS OF OPERATIONS
Three Months Ended June 30, 1999 Compared with Three Months Ended June 30,
1998.
Revenues under collaborative research and development agreements were
approximately $6,000 and $137,000 in the quarters ended June 30, 1999 and 1998,
respectively. In the quarter ended June 30, 1999, there were grant revenues of
approximately $6,000 from STTR Programs from the National Institutes of Health
("NIH") while for the quarter ended June 30, 1998 the grant revenue from the NIH
was $42,000. The balance of the revenue in the quarter ended June 30, 1998 was
$45,000 from a license agreement with Sigma Diagnostics that has since been
transferred to Criticare Systems, Inc. and $50,000 as an option payment from
Franklin Research Group, Inc.
Interest income for the quarter ended June 30, 1999 was approximately
$65,000. Interest is generated on the cash balances on hand from the proceeds of
the initial public offering in April 1999 (the "IPO"). There was no interest
income in the quarter ended June 30, 1998. There was no interest expense for the
quarter ended June 30, 1999. Interest expense for the quarter ending June 30,
1998 was $53,800.
Research and development expenses increased from approximately $310,000 in
the quarter ended June 30, 1998 to $6,615,000 in the quarter ended June 30,
1999. This is due primarily to compensation expenses of approximately $6,113,000
for the issuance of 611,250 shares of common stock pursuant to an agreement with
Pharm-Eco Laboratories, Inc. ("Pharm-Eco") and the University of North Carolina
at Chapel Hill ("UNC"), acting on behalf of a consortium of universities
including UNC, Duke University, Auburn
-14-
<PAGE>
University and Georgia State University (the "Consortium"), compensation
expenses totaling $67,000 for services relating to the issuance of stock
options, and contractual payments of $150,000 for research and development
activities.
General and administrative expenses increased in the quarter ended June
30, 1999 to approximately $350,000 from approximately $118,000 in the quarter
ended June 30, 1998. No general and administrative salaries were taken in the
quarter ended June 30, 1998. In the quarter ended June 30, 1999, salaries and
related fringes were approximately $67,000, Directors and Officers liability
insurance was $50,000, outside contractual services, including patent expenses,
increased $110,000 and compensation expense totaling $37,000 was recorded for
services relating to the issuance of stock options
The Company incurred a net loss of approximately $6,894,000 for the
quarter ended June 30, 1999 as compared with a net loss of approximately
$344,000 for the quarter ended June 30, 1998. The additional loss was primarily
due to compensation expense for services rendered and research and development
expenses related to the common stock issued to Pharm-Eco and the Consortium in
the quarter ended June 30, 1999 for an aggregate of $6,217,000.
LIQUIDITY AND CAPITAL RESOURCES
From inception through June 30, 1999, the Company financed its operations
from (i) the net proceeds of the IPO effective April 26, 1999, (ii) the net
proceeds of private placements of debt and equity securities and cash
contributed from stockholders, which in the aggregate, raised approximately
$20,173,000, (iii) payments from research agreements and SBIR grants and STTR
Program grants of approximately $1,994,000 and (iv) use of stock, options and
warrants in lieu of cash compensation.
The Company's cash resources have been used to finance research and
development, including sponsored research, capital expenditures, expenses
associated with the efforts of the Consortium and general and administrative
expenses. Over the next several years, the Company expects to incur substantial
additional research and development costs, including costs related to
early-stage research in preclinical and clinical trials, increased
administrative expenses to support its research and development operations and
increased capital expenditures for expanded research capacity, various equipment
needs and facility improvements or relocation.
The Company was a party to sponsored research agreements with UNC which
requires it to fund an aggregate of approximately $100,000 per quarter through
April 30, 2002.
The Company believes its existing resources, but not including proceeds
from any grant the Company may receive, to be sufficient to meet the Company's
planned expenditures through December 2000, although there can be no assurance
the Company will not require additional funds. The Company's working capital
requirements will depend upon numerous factors, including the progress of the
Company's research and development programs (which may vary as product
candidates are added or abandoned), preclinical testing and clinical trials,
achievement of regulatory milestones, the Company's corporate partners
fulfilling their obligations to the Company, the timing and cost of seeking
regulatory approvals, the level of resources that the Company devotes to the
development of manufacturing, the ability of the Company to maintain existing
and establish new collaborative arrangements with other companies to provide
funding to the Company to support these activities and other factors. In any
event, the Company will require substantial funds in addition to the present
existing working capital to develop its product candidates and otherwise to meet
its business objectives.
-15-
<PAGE>
YEAR 2000
Business interruptions resulting from technology problems arising out of
the Year 2000 may adversely affect companies in various industries. The Company
currently anticipates that it will still be in the process of conducting
clinical trials or otherwise developing its initial products at the onset of the
Year 2000. Consequently, it is not likely that the Company will be engaged in
time sensitive activities likely to be materially disrupted by the Year 2000
problems. Nevertheless, the Company recently assessed both its information
technology systems and other systems to determine the likelihood of a Year 2000
disruption. The Company has recently purchased new accounting software and has
been told by the vendor that it is Year 2000 compliant.
The Company is assessing the Year 2000 vulnerability of its business
partners to determine which, if any, relationships require corrective action.
The Company has received confirmation that the Company's main research
affiliates have the appropriate programs in place to achieve Year 2000
compliance.
SPECIAL NOTE--FORWARD-LOOKING STATEMENTS
Certain statements contained in this report, including, without
limitation, statements containing the words "believe," "anticipates," "expects"
and words of similar import, constitute "forward-looking statements" within the
meaning of the Private Securities Litigation Reform Act of 1995. Such
forward-looking statements involve known and unknown risks, uncertainties and
other factors that may cause the actual results, performance or achievements of
the Company, or industry results, to be materially different from any future
results, performance or achievements expressed or implied by such
forward-looking statements. Such factors include, among others, the following:
the Company's need for substantial additional funds and its access to capital
markets, the lack of any Company products currently available for sale, the
early stages of experiments and the uncertainties involved in clinical trials,
the Company's history of operating losses, the dependence of the Company on
third party relationships for the manufacture of its products and the
performance of its clinical trials, the Company's limited manufacturing
capability, existing government regulations and changes in, or the failure to
comply with, government regulations; competition; the ability to attract and
retain qualified personnel and the Company's dependence on key personnel; the
ability to protect technology, patents and proprietary information; and other
factors referenced in this report. Given these uncertainties, readers of this
report and investors are cautioned not to place undue reliance on such
forward-looking statements. The Company disclaims any obligation to update any
such factors or to publicly announce the result of any revisions to any of the
forward-looking statements contained herein to reflect future events or
developments.
Part II
Item 2. Use of Proceeds
In April 1999, the Company sold 1,150,000 shares of common stock at $10.00
per share (which included the underwriters overallotment of 150,000 shares)
through the IPO. The U.S. underwriter Westport Resources handled the placement
of 300,000 shares plus the overallotment of 150,000 shares. The international
underwriter The New China Hong Kong Securities LTD placed the remaining 700,000
shares. The gross proceeds from the IPO totaled $11,500,000 and the net proceeds
totaled $9,172,610. $2,327,390 in proceeds from the IPO were used as follows:
-16-
<PAGE>
Description Amount
----------- ------
Underwriters' Fees and Expenses $1,485,770
Legal Fees $ 450,809
Accounting Fees $ 147,468
Printing Fees $ 129,151
Blue Sky/Listing Fees $ 65,459
Travel, Promotion and Research $ 48,733
Substantially all of the remaining net proceeds of the IPO will be used to fund
the Company's research and development efforts, including clinical and
preclinical studies. Any net proceeds not applied to the Company's research and
development efforts will be used for working capital and general corporate
purposes, including hiring up to 10 additional employees. The amount and timing
of expenditures of the net proceeds of the IPO cannot be precisely determined,
and will depend on numerous factors, including the status of the Company's
product development efforts, the results of clinical trials and the regulatory
approval process. The Company may also use a portion of the net proceeds to
acquire complementary businesses, products or technologies, although the Company
has no agreements and is not involved in any negotiations with respect to any
such transaction. Pending such uses, the Company continues to invest the net
proceeds from the IPO in short-term, investment-grade, interest-bearing
securities.
Subsequent to the expenses described above and for the two months after
the IPO ended June 30, 1999, the Company has used the proceeds as follows:
Arrearage in research support $150,000
Debt elimination $110,000
Research and development generally $271,904
Patent protection $ 70,173
Working capital and general corporate purposes $296,225
Item 6. Exhibits, and Reports on Form 8-K
(A) EXHIBITS
The exhibits listed in the accompanying index to exhibits are filed or
incorporated by reference as part of this report.
(B) REPORTS ON FORM 8-K
No reports on Form 8-K have been filed during the past quarter.
-17-
<PAGE>
SIGNATURES
Pursuant to the requirements of Section 13 and 15(d) 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.
IMMTECH INTERNATIONAL, INC.
By: /s/ T. Stephen Thompson
------------------------------------
T. Stephen Thompson
Chief Executive Officer and
President
Date: August 13, 1999
/s/ Gary C. Parks
------------------------------------
Gary C. Parks
Treasurer, Secretary and Chief
Financial Officer (Principal
Financial and Accounting
Officer)
-18-
<PAGE>
EXHIBIT INDEX
Exhibit Description
- ------- -----------
27.1(1) Financial Data Schedule
-19-
<TABLE> <S> <C>
<ARTICLE> 5
<LEGEND>
THIS SCHEDULE CONTAINS SUMMARY FINANCIAL INFORMATION EXTRACTED FROM THE
FINANCIAL STATEMENTS INCLUDED IN THE REGISTRANT'S QUARTERLY REPORT ON FORM
10-QSB FOR THE QUARTERLY PERIOD ENDED JUNE 30, 1999 AND IS QUALIFIED IN ITS
ENTIRETY BY REFERENCE TO SUCH FINANCIAL STATEMENTS.
</LEGEND>
<S> <C>
<PERIOD-TYPE> 3-MOS
<FISCAL-YEAR-END> MAR-31-1999
<PERIOD-START> APR-01-1999
<PERIOD-END> JUN-30-1999
<CASH> 8,525,242
<SECURITIES> 0
<RECEIVABLES> 0
<ALLOWANCES> 0
<INVENTORY> 0
<CURRENT-ASSETS> 8,541,106
<PP&E> 358,373
<DEPRECIATION> 290,010
<TOTAL-ASSETS> 8,609,469
<CURRENT-LIABILITIES> 253,492
<BONDS> 0
0
0
<COMMON> 51,346
<OTHER-SE> 0
<TOTAL-LIABILITY-AND-EQUITY> 8,609,469
<SALES> 0
<TOTAL-REVENUES> 5,788
<CGS> 0
<TOTAL-COSTS> 6,959,064
<OTHER-EXPENSES> (204)
<LOSS-PROVISION> 0
<INTEREST-EXPENSE> (64,842)
<INCOME-PRETAX> (6,894,018)
<INCOME-TAX> 0
<INCOME-CONTINUING> 0
<DISCONTINUED> 0
<EXTRAORDINARY> 0
<CHANGES> 0
<NET-INCOME> (6,894,018)
<EPS-BASIC> (1.54)
<EPS-DILUTED> (1.54)
</TABLE>
