DISCOVERY LABORATORIES INC /DE/
10QSB, 2000-11-14
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 September 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          (I.R.S. Employer Identification No.)
of incorporation or organization)

     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

As of November 13, 2000, 20,871,112 shares of Common Stock, par value $.001 per
share, were outstanding.

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


                                                                          Page 1
<PAGE>

                          DISCOVERY LABORATORIES, INC.

                                Table of Contents

                                                                            Page
                                                                            ----
PART I - FINANCIAL INFORMATION

Item 1.  Financial Statements (unaudited)
         CONSOLIDATED BALANCE SHEETS --
            As of September 30, 2000 (unaudited) and December 31, 1999 .  Page 3

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

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

         CONSOLIDATED STATEMENTS OF CASH FLOWS (unaudited) -- For the
            Nine Months Ended September 30, 2000 and September 30,
            1999 and for the Period from May 18, 1993 (Inception)
            through September 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.  Changes 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 11


                                                                          Page 2
<PAGE>

PART I - FINANCIAL INFORMATION

ITEM 1. FINANCIAL STATEMENTS

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

Consolidated Balance Sheets

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

Current assets:
   Cash and cash equivalents                                                           $  9,566,000    $  3,547,000
   Marketable securities                                                               $ 10,282,000
   Inventory                                                                                575,000         575,000
   Prepaid expenses and other current assets                                                763,000          66,000
                                                                                       ------------    ------------

        Total current assets                                                             21,186,000       4,188,000

Property and equipment, net of depreciation                                               1,230,000         426,000
Security deposits                                                                             3,000          18,000
                                                                                       ------------    ------------

                                                                                       $ 22,419,000    $  4,632,000
                                                                                       ------------    ------------

LIABILITIES AND STOCKHOLDERS' EQUITY

Current liabilities:
   Accounts payable and accrued expenses                                               $    981,000    $    425,000
   Deferred revenue                                                                       1,036,000       1,036,000
   Capitalized lease - current                                                               15,000          15,000
                                                                                       ------------    ------------

      Total current liabilities                                                           2,032,000       1,476,000
                                                                                       ------------    ------------

Capitalized lease - noncurrent                                                               36,000          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 outstanding at
      September 30, 2000 and December 31, 1999, respectively                                      0           2,000
      Series C redeemable convertible; None and 2,039 shares issued and outstanding
      at September 30, 2000 and December 31, 1999, respectively                                   0       2,481,000
   Common stock, $.001 par value; 35,000,000 authorized; 20,851,112 and
      9,689,240 shares issued and outstanding at September 30, 2000 and December
      31, 1999 respectively                                                                  21,000          10,000
   Treasury stock (at cost; 26,743 and 2,000 shares of common stock at September 30,
      2000 and December 31, 1999, respectively)                                            (213,000)         (5,000)
   Additional paid-in capital                                                            60,500,000      33,749,000
   Unearned portion of compensatory stock options                                          (148,000)        (37,000)
   Accumulated other comprehensive income                                                   125,000
   Deficit accumulated during the development stage                                     (39,934,000)    (33,092,000)
                                                                                       ------------    ------------

        Total stockholders' equity                                                       20,351,000       3,108,000
                                                                                       ------------    ------------

                                                                                       $ 22,419,000    $  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              Nine Months Ended          (Inception)
                                                September 30,                  September 30,              Through
                                         ---------------------------    ----------------------------    September 30,
                                             2000           1999            2000            1999            2000
                                         ------------    -----------    ------------    ------------    ------------
<S>                                      <C>             <C>            <C>             <C>             <C>
Interest                                 $    283,000    $   105,000    $    601,000    $    172,000    $  2,069,000
License Fees                                  (68,000)                       (68,000)
Research Grants and funding                   606,000                        625,000                         762,000
                                         ------------    -----------    ------------    ------------    ------------
                                              821,000        105,000       1,158,000         172,000       2,831,000
                                         ------------    -----------    ------------    ------------    ------------
Expenses:
   Write-off of acquired in-process
       research and development and
       supplies                                                                                           13,508,000
   Research and development                 1,768,000        449,000       3,801,000       2,340,000      16,670,000
   General and administrative                 436,000        378,000       1,791,000       1,700,000       9,404,000
   Compensatory Stock Options                 921,000                      2,368,000                       2,510,000
   Interest                                     1,000                          4,000                          17,000
                                         ------------    -----------    ------------    ------------    ------------
        Total expenses                      3,126,000        827,000       7,964,000       4,040,000      42,109,000
                                         ------------    -----------    ------------    ------------    ------------

                                           (2,305,000)      (722,000)     (6,806,000)     (3,868,000)    (39,278,000)

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

Net loss                                   (2,305,000)      (722,000)     (6,806,000)     (3,868,000)    (39,252,000)

Other comprehensive income:
   Unrealized gain on marketable
   securities available for sale              169,000         (1,000)        125,000          (6,000)        125,000
                                         ------------    -----------    ------------    ------------    ------------

Total comprehensive loss                 $ (2,136,000)   $  (723,000)   $ (6,681,000)   $ (3,874,000)   $(39,127,000)
                                         ============    ===========    ============    ============    ============

Net loss per share - basic and diluted   $      (0.10)   $     (0.09)   $      (0.37)   $      (0.49)
                                         ============    ===========    ============    ============

Weighted average number of common
shares outstanding                         20,837,000      8,415,000      18,120,000       7,945,000
                                         ============    ===========    ============    ============
</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 September 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                        512,059            (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        9,496

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

Unrealized gain on marketable securities
available for sale

Treasury Stock Issues in payment for services                         7,000   $  37,000

Net Loss
------------------------------------------------------------------------------------------------------------------------------------
Balance - September 30, 2000                  20,851,112  $ 21,000  (26,743)  $(213,000)        --          --       --          --
------------------------------------------------------------------------------------------------------------------------------------

<CAPTION>
                                                                                   Deficit
                                                                                 Accumulated
                                                 Additional  Unearned Portion      during       Accumulated Other
                                                  Paid-In     of Compenstory     Development      Comprehensive
                                                  Capital      Stock 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                            480,000                                                         235,000

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                                    2,136,000                                                       2,136,000

Compensatory stock options granted                   343,000     (111,000)                                           232,000

Common stock issued in payment for services           47,000                                                          47,000

Issuance of private placement units               17,441,000                                                      17,444,000

Unrealized gain on marketable securities
available for sale                                                                                   125,000         125,000

Treasury Stock Issues in payment for services                                                                         37,000

Net Loss                                                                          (6,806,000)                     (6,806,000)
-----------------------------------------------------------------------------------------------------------------------------
Balance - September 30, 2000                     $60,500,000    $(148,000)      $(39,934,000)      $ 125,000    $ 20,351,000
-----------------------------------------------------------------------------------------------------------------------------
</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)
                                                                            Nine Months Ended            Through
                                                                               September 30,           September 30,
                                                                            2000           1999             2000
                                                                        ------------    -----------    ------------
<S>                                                                     <C>             <C>            <C>
Cash flows from operating activities:
   Net loss                                                             $ (6,806,000)   $(3,868,000)   $(39,252,000)
   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                                         89,000         60,000         305,000
        Compensatory stock options                                         2,368,000        124,000       2,510,000
        Expenses paid using treasury stock and common stock                   84,000                        162,000
        Changes in:
           Prepaid expenses and other current assets                        (697,000)       137,000        (732,000)
           Accounts payable and accrued expenses                             556,000       (473,000)        848,000
           Deferred revenue                                                                               1,036,000
           Other assets                                                       15,000                         (3,000)
        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                          (4,391,000)    (4,020,000)    (21,036,000)
                                                                        ------------    -----------    ------------
Cash flows from investing activities:
   Purchase of furniture and equipment                                      (893,000)      (172,000)     (1,439,000)
   Proceeds from disposal of furniture and equipment                                                         25,000
   Acquisition of licenses                                                                                 (711,000)
   Purchase of marketable securities                                     (10,157,000)    (1,000,000)    (31,902,000)
   Proceeds from sale or maturity of investments                                          2,126,000      22,150,000
   Net cash payments on merger                                                                           (1,670,000)
                                                                        ------------    -----------    ------------
           Net cash provided by (used in) investing activities           (11,050,000)       954,000     (13,547,000)
                                                                        ------------    -----------    ------------
Cash flows from financing activities:
   Proceeds from private placements of units, net of expenses             17,444,000      3,273,000      40,166,000
   Purchase of treasury stock                                                                (5,000)        (95,000)
   Principal payments under capital lease obligation                         (12,000)                       (22,000)
   Collections on stock subscriptions and proceeds from conversion of
       stock options and warrants                                          4,028,000         12,000       4,100,000
                                                                        ------------    -----------    ------------
           Net cash (used in) provided by financing activities            21,460,000      3,280,000      44,149,000
                                                                        ------------    -----------    ------------
Net (decrease) increase in cash and cash equivalents                       6,019,000        214,000       9,566,000
Cash and cash equivalents - beginning of period                            3,547,000      1,474,000
                                                                        ------------    -----------    ------------
Cash and cash equivalents - end of period                               $  9,566,000    $ 1,688,000    $  9,566,000
                                                                        ------------    -----------    ------------

Supplementary disclosure of cash flows information:
    Interest Paid:                                                      $      4,000                   $     17,000
Noncash transactions:
   Accrued dividends on preferred stock                                 $     36,000    $   153,000    $    682,000
   Common stock and treasury stock issued in payment for services             84,000         73,000         157,000
   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 nine-month period ended September 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 $39.3 million as of September
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 generate 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 on its products. Primary focus will be on
the conduct of clinical trials for the Surfaxin(R) indications and on
preclinical research related to using Surfaxin(R)-like formulations as an
aerosol therapeutic, as well as a platform pulmonary drug delivery technology.
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. In anticipation of
optimizing the commercial process for Surfaxin(R), the Company is considering
the purchase of


                                                                          Page 7
<PAGE>

additional equipment at a cost of approximately $500,000. Since May 2000, the
Company has hired approximately 10 additional personnel to expand the late stage
clinical development of Surfaxin(R) and anticipates hiring additional personnel
to further augment the development of Surfaxin(R) and SuperVent(TM).

In November, the Company established a satellite office in the United Kingdom to
manage and oversee its European clinical research programs. In addition, the
Company plans to expand its clinical trial capabilities in other parts of the
world.

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. Results of a Phase 2 clinical trial in MAS in
full-term newborns showed an improvement in oxygenation parameters and a savings
of approximately three days on mechanical ventilation with the use of
Surfaxin(R). 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 towards reducing the costs of this Phase 3
trial. The Company has received Fast Track designation for Surfaxin(R) from the
FDA for MAS. The Company has previously been granted Orphan Drug Status 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 clearance by the FDA
and/or world health authorities. There can be no assurance as to the receipt or
the timing of such clearance.

The Company has previously been granted Orphan Drug Status for Surfaxin(R) from
the FDA for RDS.

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

A pivotal Phase 2/3 clinical trial of Surfaxin(R) for the treatment of 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 during
the fourth quarter of 2000. The Company has received Fast Track designation for
Surfaxin(R) from the FDA for ARDS. The Company has previously been granted
Orphan Drug Status 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. Analysis of the data shows that SuperVent(TM)
significantly 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.

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 has recently terminated
its license of DSC-103 with the licensor.

Results of Operations

The Company's expenses increased from $4,040,000 in the nine months ended
September 30, 1999, to $7,964,000 in the nine months ended September 30, 2000.
The increase was primarily due to a compensation charge of $2,368,000 recorded
as a result of the grant of options and the vesting of certain milestone-based
employee stock options (including 250,000 options whose vesting was accelerated
by the Board of Directors) and an increase in the Company's research and
development activities. The Company's total comprehensive net loss increased
from $3,874,000 in the nine months ended September 30, 1999, to $6,681,000 in
the nine months


                                                                          Page 8
<PAGE>

ended September 30, 2000. In addition, due to the increase in the weighted
average common shares outstanding during the first nine months of 2000, the
Company's net loss per share decreased from $0.49 in 1999 to $0.37 in 2000.

Liquidity

At September 30, 2000, the Company had working capital of $19.2 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.

None.

ITEM 3. DEFAULTS UPON SENIOR SECURITIES.

None.

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

None.

ITEM 5. OTHER INFORMATION.

In October 2000, the Company was awarded a $1 million Fast-Track Small Business
Innovative Research (SBIR) grant by the US National Institutes of Health (NIH)
to develop Surfaxin(R) for asthma, drug delivery, and respiratory distress
syndromes.

The Company has decided not to pursue its planned occupation of a building
adjacent to its Doylestown, Pennsylvania headquarters that was originally
intended for its expanded clinical research activities. The Company has,
however, as a lower cost alternative, amended its existing lease agreement in
September 2000 to include an additional approximately 4,000 square feet of space
immediately adjacent to its offices. The Company sold the adjacent building on
October 30, 2000, for approximately $565,000 in cash. After taking into account
transaction costs, the proceeds from the sale of the building approximated its
purchase price.

Pursuant to its sublicense agreement with Laboratorios Dr. Esteve of Spain, one
of Spain's leading pharmaceutical companies, the Company received approximately
$600,000 in cash in October 2000 in support of its research and development
activities with respect to Surfaxin(R).

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

      (a) Exhibits:

            27.1  Financial Data Schedule.

      (b) Reports on Form 8-K:

            1.    None.


                                                                         Page 10
<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: November 14, 2000                     /s/ Robert J. Capetola, Ph.D.
                                            ----------------------------------
                                            Robert J. Capetola, Ph.D.
                                            President/Chief Executive Officer

Date: November 14, 2000                     /s/ Evan Myrianthopoulos
                                            ----------------------------------
                                            Evan Myrianthopoulos
                                            Vice President, Finance
                                            (Principal Financial Officer)

Date: November 14, 2000                     /s/ Cynthia Davis
                                            ----------------------------------
                                            Cynthia Davis
                                            Controller
                                            (Principal Accounting Officer)


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