DISCOVERY LABORATORIES INC /DE/
10QSB, 2000-08-16
BIOLOGICAL PRODUCTS, (NO DIAGNOSTIC SUBSTANCES)
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                       SECURITIES AND EXCHANGE COMMISSION
                             WASHINGTON, D.C. 20549

                                   FORM 10-QSB

|X|   QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT
      OF 1934

                  For the quarterly period ended June 30, 2000

                                       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 000-26422

                          DISCOVERY LABORATORIES, INC.
        (Exact name of small business issuer as specified in its charter)

                  Delaware                                  94-3171943
(State or other jurisdiction of incorporation            (I.R.S. Employer
               or organization)                          Identification No.)

      350 South Main Street, Suite 307
          Doylestown, Pennsylvania                             18901
  (Address of principal executive offices)                  (Zip Code)

       Registrants' telephone number, including area code: (215) 340-4699

      Securities registered under Section 12 (b) of the Exchange Act: None

         Securities registered under Section 12 (g) of the Exchange Act:

                     Common Stock, par value $.001 per share

Indicate by check mark whether the Registrant (1) has filed all reports required
to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the preceding 12 months (or for such shorter period that the Registrant was
required to file such reports), and (2) has been subject to such filing
requirements for the past 90 days. |X| Yes |_| No

As of August 10, 2000, 20,840,353 shares of Common Stock, par value $.001 per
share, were outstanding.

Documents incorporated by reference: None.

Transitional Small Business Disclosure Format: |_| Yes |X| No


                                                                          Page 1
<PAGE>

                          DISCOVERY LABORATORIES, INC.

                                Table of Contents

<TABLE>
<CAPTION>
                                                                                       Page

PART I - FINANCIAL INFORMATION
<S>                                                                                     <C>
      Item 1.  Financial Statements (unaudited)
               CONSOLIDATED BALANCE SHEETS --
                 As of June 30, 2000 (unaudited) and December 31, 1999..................Page 3

               CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited) --
                 For the Three and Six Months Ended June 30, 2000 and
                 June 30, 1999 and for the Period from May 18, 1993 (Inception)
                 through June 30, 2000..................................................Page 4

               CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS EQUITY
                 (unaudited)-- For the Six Months Ended June 30, 2000...................Page 5

               CONSOLIDATED STATEMENTS OF CASH FLOWS (unaudited)--
                 For the Six Months Ended June 30, 2000 and June 30, 1999
                 and for the Period from May 18, 1993 (Inception)
                 through June 30, 2000..................................................Page 6

                 Notes to Financial Statements..........................................Page 7

      Item 2.  Management's Discussion and Analysis of Financial Condition
               and Results of Operations................................................Page 7

PART II - OTHER INFORMATION

      Item 1.  Legal Proceedings.......................................................Page 10
      Item 2.  Change in Securities....................................................Page 10
      Item 3.  Defaults Upon Senior Securities.........................................Page 10
      Item 4.  Submission of Matters to a Vote of Security Holders.....................Page 10
      Item 5.  Other Information.......................................................Page 10
      Item 6.  Exhibits and Reports on Form 8-K........................................Page 10

      Signatures.......................................................................Page 12
</TABLE>


                                                                          Page 2
<PAGE>

DISCOVERY LABORATORIES, INC. AND SUBSIDIARY
(a development stage company)

Consolidated Balance Sheets

<TABLE>
<CAPTION>
                                                                           June 30,      December 31,
                                                                             2000            1999
                                                                         ------------    ------------
                                                                          (Unaudited)
<S>                                                                      <C>             <C>
ASSETS

Current assets:
  Cash and cash equivalents                                              $ 11,813,000    $  3,547,000
  Marketable securities                                                  $ 10,038,000
  Inventory                                                                   575,000         575,000
  Prepaid expenses and other current assets                                   233,000          66,000
                                                                         ------------    ------------

      Total current assets                                                 22,659,000       4,188,000

Property and equipment, net of deprecation                                    527,000         426,000
Security deposits                                                              69,000          18,000
                                                                         ------------    ------------

                                                                         $ 23,255,000    $  4,632,000
                                                                         ------------    ------------

LIABILITIES AND STOCKHOLDERS' EQUITY

Current liabilities:
  Accounts payable and accrued expenses                                  $    678,000    $    425,000
  Deferred revenue                                                          1,036,000       1,036,000
  Capitalized lease - current                                                  15,000          15,000
                                                                         ------------    ------------

    Total current liabilities                                               1,729,000       1,476,000
                                                                         ------------    ------------

Capitalized lease - noncurrent                                                 40,000          48,000
                                                                         ------------    ------------

Stockholders' Equity:
  Preferred stock, $.001 par value; 5,000,000 shares authorized:
    Series B convertible; None and 1,530,756 shares issued and                      0           2,000
    outstanding at June 30, 2000 and December 31, 1999, respectively
    Series C redeemable convertible; None and 2,039 shares issued and               0       2,481,000
    outstanding at June 30, 2000 and December 31, 1999, respectively
  Common stock, $.001 par value; 35,000,000 authorized; 20,829,652 and         21,000          10,000
    9,689,240 shares issued and outstanding at June 30, 2000 and
    December 31, 1999 respectively
  Treasury stock (at cost; 33,743 and 2,000 shares of common stock at        (250,000)         (5,000)
    June 30, 2000 and December 31, 1999, respectively)
  Additional paid-in capital                                               59,536,000      33,749,000
  Unearned portion of compensatory stock options                             (148,000)        (37,000)
  Accumulated other comprehensive loss                                        (44,000)
  Deficit accumulated during the development stage                        (37,629,000)    (33,092,000)

      Total stockholders' equity                                           21,486,000       3,108,000
                                                                         ------------    ------------

                                                                         $ 23,255,000    $  4,632,000
                                                                         ------------    ------------
</TABLE>

See notes to financial statements


                                                                          Page 3
<PAGE>

DISCOVERY LABORATORIES, INC. AND SUBSIDIARY
(a development stage company)

Consolidated Statements of Operations
(Unaudited)

<TABLE>
<CAPTION>
                                                                                                 May 18, 1993
                                       Three Months Ended              Six Months Ended           (Inception)
                                            June 30,                       June 30,                  Through
                                   ---------------------------    ----------------------------       June 30,
                                       2000           1999            2000            1999            2000
                                   ------------    -----------    ------------    ------------    ------------
<S>                                <C>             <C>            <C>             <C>             <C>
Interest                           $    296,000    $    30,000    $    318,000    $     67,000    $  1,786,000
License Fees                                                                                            68,000
Research Grants                                                         19,000                         156,000
                                   ------------    -----------    ------------    ------------    ------------
                                        296,000         30,000         337,000          67,000       2,010,000
                                   ------------    -----------    ------------    ------------    ------------

Expenses:
  Write-off of acquired
     in-process research and
     development and supplies                                                                       13,508,000
  Research and development            1,259,000        472,000       2,033,000       1,891,000      14,902,000
  General and administrative            620,000        686,000       1,355,000       1,322,000       8,968,000
  Compensatory Stock Options            634,000                      1,447,000                       1,589,000
  Interest                                1,000                          3,000                          16,000
                                   ------------    -----------    ------------    ------------    ------------

      Total expenses                  2,514,000      1,158,000       4,838,000       3,213,000      38,983,000
                                   ------------    -----------    ------------    ------------    ------------

                                     (2,218,000)    (1,128,000)     (4,501,000)     (3,146,000)    (36,973,000)

Minority interest in net loss of                                                                        26,000
subsidiary                         ------------    -----------    ------------    ------------    ------------

Net loss                             (2,218,000)    (1,128,000)     (4,501,000)     (3,146,000)    (36,947,000)

Other comprehensive income:
  Unrealized loss on marketable
  securities available for sale         (44,000)        (2,000)        (44,000)         (5,000)        (44,000)
                                   ------------    -----------    ------------    ------------    ------------

Total comprehensive loss           $ (2,262,000)   $(1,130,000)   $ (4,545,000)   $ (3,151,000)   $(36,991,000)
                                   ============    ===========    ============    ============    ============

Net loss per share - basic
and diluted                        $      (0.11)   $     (0.18)   $      (0.27)   $      (0.51)
                                   ============    ===========    ============    ============

Weighted average number of
common shares outstanding            20,800,000      6,597,000      16,734,000       6,121,000
                                   ============    ===========    ============    ============
</TABLE>

See notes to financial statements


                                                                          Page 4
<PAGE>

DISCOVERY LABORATORIES, INC. AND SUBSIDIARY
(a development stage company)

Consolidated Statements of Changes in Stockholders' Equity
January 1, 2000 through June 30, 2000


<TABLE>
<CAPTION>
                                                                                                     Preferred Stock
                                                                                         -------------------------------------------
                                            Common Stock           Treasury Stock             Series B            Series C
                              ------------------------------------------------------------------------------------------------------
                                        Shares         Amount    Shares        Amount      Shares    Amount    Shares   Amount
<S>                                    <C>            <C>       <C>           <C>        <C>        <C>       <C>       <C>
Balance -- January 1, 2000             9,689,240      $ 10,000   (2,000)      $ (5,000)  1,530,756  $2,000     2,039    $ 2,481,000

Exercise of Stock Options                492,059                (31,743)      (245,000)

Common placement warrant
conversions                               18,232

Preferred placement warrant
conversions                               18,511

Exercise of Class C & D Warrants       2,536,911         3,000

Series B preferred stock conversions   4,765,631         5,000                          (1,530,756) (2,000)

Dividend Payable on Series C
preferred stock                                                                                                              36,000

Series C prefered stock conversions      398,186                                                              (2,039)    (2,517,000)

Compensation charge on
vesting/exercisability of stock option

Compensatory stock options granted

Common stock issued in payment
for services                               8,036

Issuance of private placement units    2,902,846         3,000


Unrealized loss on marketable
securities available for sale

Net Loss
==================================================================================================================================
Balance   June 30, 2000               20,829,652      $ 21,000  (33,743)     $(250,000)         --      --        --           --
==================================================================================================================================

<CAPTION>

                                                                                      Deficit
                                                                                   Accumulated
                                           Additional      Unearned Portion of        during       Accumulated Other
                                            Paid In        Compensatory Stock       Development      Comprehensive
                                            Capital             Options                 Stage            Income         Total
<S>                                     <C>                   <C>                <C>                   <C>          <C>
Balance -- January 1, 2000              $33,749,000           $ (37,000)         $ (33,092,000)        $   --       $  3,108,000

Exercise of Stock Options                   445,000                                                                      200,000

Common placement warrant
conversions                                                                                                                   --

Preferred placement warrant
conversions                                                                                                                   --

Exercise of Class C & D Warrants          3,790,000                                                                    3,793,000

Series B preferred stock conversions         (3,000)                                                                          --

Dividend Payable on Series C
preferred stock                                                                        (36,000)                               --

Series C prefered stock conversions       2,517,000                                                                           --

Compensation charge on
vesting/exercisability of stock option    1,215,000                                                                    1,215,000

Compensatory stock options granted          343,000                                                                      232,000

Common stock issued in payment                                                                                            40,000
for services                                 40,000              (111,000)

Issuance of private placement units      17,440,000                                                                   17,443,000

Unrealized loss on marketable
securities available for sale                                                                          (44,000)         (44,000)

Net Loss                                                                            (4,501,000)                      (4,501,000)
==================================================================================================================================
Balance --  June 30, 2000               $59,536,000            $ (148,000)       $ (37,629,000)      $ (44,000)    $ 21,486,000
==================================================================================================================================
</TABLE>

See notes to financial statements


                                                                          Page 5
<PAGE>

DISCOVERY LABORATORIES, INC. AND SUBSIDIARY
(a development stage company)

Consolidated Statements of Cash Flows
(Unaudited)

<TABLE>
<CAPTION>
                                                                                     May 18, 1993
                                                                                      (Inception)
                                                           Six Months Ended             Through
                                                                June 30,                June 30,
                                                          2000            1999            2000
                                                      ------------    ------------    ------------
<S>                                                   <C>             <C>             <C>
Cash flows from operating activities:
  Net loss                                            $ (4,501,000)   $ (3,146,000)   $(36,947,000)
  Adjustments to reconcile net loss to net cash
    used in operating activities
      Write-off of acquired in-process research
        and development and supplies                                                    13,508,000
      Write-off of licenses                                                                683,000
      Depreciation and amortization                         53,000          39,000         269,000
      Compensatory stock options                         1,447,000         124,000       1,589,000
      Expenses paid using treasury stock and
        common stock                                        40,000                         118,000
      Changes in:
        Prepaid expenses and other current assets         (167,000)        135,000        (202,000)
        Accounts payable and accrued expenses              253,000          69,000         545,000
        Deferred revenue                                                                 1,036,000
        Other assets                                       (51,000)                        (69,000)
      Expenses paid on behalf of company                                                    18,000
      Employee stock compensation                                                           42,000
      Reduction of research and development
        supplies                                                                          (161,000)
                                                      ------------    ------------    ------------

        Net cash used in operating activities           (2,926,000)     (2,780,000)    (19,571,000)
                                                      ------------    ------------    ------------

Cash flows from investing activities:
  Purchase of furniture and equipment                     (156,000)        (33,000)       (702,000)
  Proceeds from disposal of furniture and
     equipment                                                                              25,000
  Acquisition of licenses                                                                 (711,000)
  Purchase of marketable securities                    (10,082,000)                    (31,827,000)
  Proceeds from sale or maturity of investments                          1,063,000      22,150,000
  Net cash payments on merger                                                           (1,670,000)
                                                      ------------    ------------    ------------

        Net cash provided by (used in) investing
          activities                                   (10,238,000)      1,030,000     (12,735,000)
                                                      ------------    ------------    ------------

Cash flows from financing activities:
  Proceeds on private placements of units, net
     of expenses                                        17,444,000                      40,166,000
  Purchase of treasury stock                                                (5,000)        (95,000)
  Principal payments under capital lease
     obligation                                             (8,000)                        (18,000)
  Collections on stock subscriptions and
     proceeds on conversion of stock options and
     warrants                                            3,994,000       1,009,000       4,066,000
                                                      ------------    ------------    ------------
        Net cash (used in) provided by financing
          activities                                    21,430,000       1,004,000      44,119,000
                                                      ------------    ------------    ------------

Net (decrease) increase in cash and cash
  equivalents                                            8,266,000        (745,000)     11,813,000
Cash and cash equivalents - beginning of period          3,547,000       1,474,000
                                                      ------------    ------------    ------------

Cash and cash equivalents - end of period             $ 11,813,000    $    729,000    $ 11,813,000
                                                      ============    ============    ============

Supplementary disclosure of cash flows information:
   Interest Paid:                                     $      3,000    $               $     16,000
Noncash transactions:
  Accrued dividends on preferred stock                $     36,000    $    102,000    $    682,000
  Common stock and treasury stock issued in
      payment of services                                   40,000          69,000         113,000
  Preferred Stock issued for inventory                                                     575,000
  Treasury stock received on exercise of options           245,000                         245,000
  Equipment acquired through capitalized lease                                              73,000
  Series C preferred stock dividends paid using
      common stock                                                                         204,000
</TABLE>

See notes to financial statements


                                                                          Page 6
<PAGE>

NOTE 1 - THE COMPANY AND BASIS OF PRESENTATION

The Company

Discovery Laboratories, Inc. (the "Company"), was formed to license and develop
pharmaceutical products to treat a variety of human diseases. The accompanying
financial statements include the accounts of the Company and its wholly owned
subsidiary, Acute Therapeutics, Inc. ("ATI"). ATI is presently inactive, and all
intercompany balances and transactions have been eliminated.

The accompanying unaudited, consolidated, condensed financial statements have
been prepared in accordance with generally accepted accounting principles for
interim financial information in accordance with the instructions to Form
10-QSB. Accordingly, they do not include all of the information and footnotes
required by generally accepted accounting principles for complete financial
statements. In the opinion of management, all adjustments (consisting of
normally recurring accruals) considered for fair presentation have been
included. Operating results for the six-month period ended June 30, 2000, are
not necessarily indicative of the results that may be expected for the year
ended December 31, 2000. For further information, refer to the consolidated
financial statements and footnotes thereto included in the Company's 1999 Annual
Report on Form 10-KSB.

The Company's activities since incorporation have primarily consisted of
conducting research and development, performing business and financial planning
and raising capital. Accordingly, the Company is considered to be in the
development stage, and expects to incur increasing losses and require additional
financial resources to achieve commercialization of its products.

The Company also depends on third parties to conduct research on the Company's
behalf through various research agreements. All of the Company's current
products under development are subject to license agreements that will require
the payment of future royalties.

Net Loss Per Share

Net loss per share is computed based on the weighted average number of common
shares outstanding for the periods and common shares issuable for little or no
cash consideration. Common shares issuable upon the exercise of options and
warrants and the conversion of convertible securities are not included in the
calculation of the net loss per share as their effect would be antidilutive.

ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS

Plan of Operations

Since its inception, the Company has concentrated its efforts and resources on
the development and commercialization of pharmaceutical products and
technologies. The Company has been unprofitable since its inception and has
incurred a cumulative net loss of approximately $36.9 million as of June 30,
2000. The Company expects to incur significantly increasing operating losses
over the next several years, primarily due to the expansion of its research and
development programs, including clinical trials for some or all of its existing
products and technologies and other products and technologies that it may
acquire or develop. The Company's ability to achieve profitability depends upon,
among other things, its ability to discover and develop products, obtain
regulatory approval for its proposed products and enter into agreements for
product development, manufacturing and commercialization. None of the Company's
products currently generates revenues and the Company does not expect to achieve
product revenues for the foreseeable future. Moreover, there can be no assurance
that the Company will ever achieve significant revenues or profitable operations
from the sale of any of its products or technologies.

The Company is a development stage pharmaceutical company that is focused on
developing compounds intended for use in critical care hospital settings. The
Company is also developing its lead product candidate, Surfaxin(R), for the
treatment of various critical care respiratory conditions. The Company
anticipates that during the next 12 months it will conduct substantial research
and development of its compounds.

The Company anticipates that during the next 12 months it will conduct
substantial research and development of its products under development and that
it will focus primarily on the conduct of clinical trials for Surfaxin(R)
indications. The Company expects to continue to expand its research and
development activities as a result of its receipt of approximately $17.4 million
of net proceeds from its offering completed in March 2000. The Company


                                                                          Page 7
<PAGE>

anticipates the near term acquisition of equipment necessary to manufacture
Surfaxin(R). The Company also anticipates the hiring of further personnel to
augment the clinical development of Surfaxin(R).

SURFAXIN(R) (lucinactant)

Meconium Aspiration Syndrome (MAS) in full-term infants

The Company recently initiated a pivotal Phase 3 trial in MAS. The trial intends
to enroll 200 MAS patients. The Company announced results of a Phase 2 clinical
trial in MAS in full-term newborns in February 1999. The 22-patient Phase 2
trial showed an improvement in oxygenation parameters and a three-day savings on
mechanical ventilation. An Orphan Products Development Grant awarded to the
Company by the United States Food and Drug Administration (the "FDA") Office of
Orphan Products Development is expected to contribute significantly towards
reducing the costs of this Phase 3 trial. The Company has received Fast Track
designation for Surfaxin(R) from the FDA for MAS.

Respiratory Distress Syndrome (RDS) in premature infants

The Company is currently planning to commence a Phase 3 clinical trial of
Surfaxin(R) for the treatment of RDS in premature infants during fourth quarter
of 2000. Such trial, and any other clinical trials of the Company's products in
development that have not yet commenced, will require the approvals by the FDA
and/or world health authorities. There can be no assurance as to the receipt or
the timing of such approvals.

Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS)

A pivotal Phase 2/3 clinical trial of Surfaxin(R) for the treatment of ALI/ARDS
was commenced in July 1998. This trial was stopped on January 27, 2000, due to
the Company's cash position and so that a new Phase 2 ARDS/ALI trial could be
commenced using a new, less viscous formulation of Surfaxin(R). A new Phase 2
trial is currently being planned, which the Company expects to commence
following submission of a protocol and subsequent agreement by the FDA. The
Company has received Fast Track designation for Surfaxin(R) from the FDA for
ARDS.

SUPERVENT(TM) (tyloxapol)

Cystic Fibrosis (CF)

The Company began a Phase 2A clinical trial of SuperVent(TM) for the treatment
of CF on August 4, 1999. Preliminary analysis of the data shows that
SuperVent(TM) decreased the amount of Interleukin 8 (IL-8) in the sputum of
treated patients compared to controls. IL-8 is an important body chemical that
causes the migration of inflammatory cells to the site of release. The Phase 2A
clinical trial involved 8 patients. An additional Phase 2 trial will likely be
required prior to commencement of a Phase 3 trial. Previously, the Company
completed a Phase 1 trial in 20 normal healthy volunteers and determined a dose
(1.25% tyloxapol concentration) that did not produce significant adverse
effects.

Chronic Bronchitis (CB)

The Company plans to investigate the potential clinical application of
SuperVent(TM) in CB following its successful Phase 2 trial in CF. A pilot study
will be reviewed during 2000.

DSC-103 (Vitamin D analog)

Postmenopausal Osteoporosis

On December 5, 1997, a Phase 1 clinical study of DSC-103 as a once-daily, orally
administered drug for the treatment of postmenopausal osteoporosis in the United
States was initiated. Part B of such trial was commenced on April 2, 1998, and
was successfully completed on June 29, 1998. The Company is discussing with the
licensor of DSC-103 the possibility of terminating its license.

Results of Operations

The Company's expenses increased from $3,213,000 in the six months ended June
30, 1999, to $4,501,000 in the six months ended June 30, 2000. The increase was
primarily due to a compensation charge of $1,447,000 recorded as a result of the
grant of options and the vesting of certain milestone-based employee stock
options and an increase in the Company's research and development activities.
The Company's total comprehensive net loss increased from $3,151,000 in the six
months ended June 30, 1999, to $4,838,000 in the six months ended June 30, 2000.
In addition, due to the increase in the weighted average common shares
outstanding during the first half of 2000, the Company's net loss per share
decreased from $0.51 in 1999 to $0.27 in 2000.


                                                                          Page 8
<PAGE>

Liquidity

At June 30, 2000, the Company had working capital of $20.9 million. In March
2000, the Company completed a private placement from which it received net
proceeds of approximately $17.4 million. The Company believes it has sufficient
resources to meet its planned research and development activities through the
first quarter of 2002.

The Company will be required to raise additional capital in order to meet its
business objectives, and there can be no assurance that it will be successful in
doing so or, in general, that the Company will be able to achieve its business
objectives.

The Company's working capital requirements will depend upon numerous factors,
including, without limitation, progress of the Company's research and
development programs, preclinical and clinical testing, timing and cost of
obtaining regulatory approvals, levels of resources that the Company devotes to
the development of manufacturing and marketing capabilities, technological
advances, status of competitors and the ability of the Company to establish
collaborative arrangements with other organizations.

Safe Harbor Statement Under the Private Securities Litigation Act of 1996

Certain statements set forth in this report, including, without limitation,
statements concerning the Company's research and development programs, the
possibility of submitting regulatory filings for the Company's products under
development, the seeking of collaboration arrangements with pharmaceutical
companies or others to develop, manufacture and market products, the research
and development of particular compounds and technologies and the period of time
for which the Company's existing resources will enable the Company to fund its
operations, are forward-looking statements. All such statements involve
significant risks and uncertainties. Actual results may differ materially from
those contemplated in the forward looking statements as a result of risks and
uncertainties, including but not limited to the following: the Company's ability
to obtain substantial additional funds; the uncertainties inherent in the
process of developing products of the kind being developed by the Company; the
Company's ability to establish additional collaborative and licensing
arrangements and the degree of success of the Company's collaboration partners;
the Company's ability to obtain and maintain all necessary patents or licenses;
the Company's ability to demonstrate the safety and efficacy of product
candidates and to receive required regulatory approvals; the Company's ability
to meet obligations and required milestones under its license agreement; the
Company's ability to compete successfully against other products and to market
products in a profitable manner; and other risks and uncertainties set forth in
the Company's filings with the Securities and Exchange Commission.


                                                                          Page 9
<PAGE>

PART II - OTHER INFORMATION

ITEM 1. LEGAL PROCEEDINGS

None.

ITEM 2. CHANGE IN SECURITIES.

In April 2000, the Company issued 713 shares of Common Stock, $.001 par value
per share, of the Company in payment of rent.

For the issuance described above, the securities received by investors were
deemed to be exempt from registration under the Act in reliance on Section 4(2)
thereof because such issuance did not involve a public offering. Investors in
each financing represented their intention to acquire the securities for
investment only and not with a view to or for sale in connection with any
distribution thereof and appropriate legends were affixed to the securities
certificates issued in such transactions. The investors in such financing had
adequate access to information about the Company. Moreover, such investors
represented to the Company, and the Company believed, that they were experienced
in financial matters.

ITEM 3. DEFAULTS UPON SENIOR SECURITIES.

None.

ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS.

At an annual meeting of the stockholders of the Company, held on June 16, 2000,
the following matters were voted on by the stockholders: (i) the election of six
directors and (ii) approval of an amendment to the 1998 Stock Incentive Plan
(the "Plan") to increase the number of shares of Common Stock available for
issuance under the Plan and to modify the terms of the automatic grants to
non-employee Board members.

(i) Election of Directors
                                        For                Withheld
                                     ----------          ------------
Robert J. Capetola, Ph.D.           11,402,869              22,798
Max Link, Ph.D.                     11,380,146              45,521
Herbert H. McDade, Jr.              11,371,946              53,721
Richard G. Power                    11,366,727              58,940
Mark C. Rogers, M.D.                11,415,369              10,298
Marvin E. Rosenthale, Ph.D.         11,414,969              10,698

(ii) Amendment to 1998 Stock Incentive Plan

For               Against                 Abstain
---               -------                 -------
11,022,609        227,022                 176,036


                                                                         Page 10
<PAGE>

ITEM 5. OTHER INFORMATION.

Form 10-QSB for the quarterly period ended March 31, 2000 was amended August,
2000, to report a restatement of first quarter 2000 financial results. The
restatement reports a compensation charge of $812,500 during the first quarter
due to the vesting of certain milestone-based options granted to employees. See
Form 10-QSB/A for more information.

ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K.

      (a)   Exhibits:

            10.1  Amended and Restated 1998 Stock Incentive Plan.

            27.1  Financial Data Schedule.


                                                                         Page 11
<PAGE>

      (b)   Reports on Form 8-K:

            1.    None.


                                                                         Page 12
<PAGE>

SIGNATURES

In accordance with the requirements of the Exchange Act, the Registrant has
caused this report to be signed on its behalf by the undersigned, thereunto duly
authorized.

                                     Discovery Laboratories, Inc.
                                           (Registrant)


Date: August 15, 2000                /s/ Robert J. Capetola, Ph.D.
                                     ------------------------------
                                     Robert J. Capetola, Ph.D.
                                     President/Chief Executive Officer


Date: August 15, 2000                /s/ Evan Myrianthopoulos
                                     ------------------------------
                                     Evan Myrianthopoulos
                                     Vice President, Finance
                                     (Principal Financial Officer)


Date: August 15, 2000                /s/ Cynthia Davis
                                     ------------------------------
                                     Cynthia Davis
                                     Controller
                                     (Principal Accounting Officer)


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