ORTEC INTERNATIONAL INC
10QSB, 1996-11-12
MEDICAL LABORATORIES
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<PAGE>   1



                       SECURITIES AND EXCHANGE COMMISSION

                             WASHINGTON, D.C. 20549
                                  -------------

                                   FORM 10-QSB
                                  -------------
(Mark One)
[X]               QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
                  SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTER ENDED
                  SEPTEMBER 30, 1996

[  ]              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 0-27368


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

             DELAWARE                                           11-3068704
   (State or other jurisdiction of                           (I.R.S. Employer
    incorporation or organization)                          Identification No.)

           3690 BROADWAY
         NEW YORK, NEW YORK                                       10032
(Address of principal executive offices)                        (Zip Code)

                                 (212) 740-6999
                 Issuer's telephone number, including area code




                                ----------------


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



       The number of shares outstanding of the issuer's common stock is
3,956,032 (as of November 12, 1996).




<PAGE>   2





                            ORTEC INTERNATIONAL, INC.
                    INDEX TO QUARTERLY REPORT ON FORM 10-QSB
                FILED WITH THE SECURITIES AND EXCHANGE COMMISSION
                           QUARTER ENDED JUNE 30, 1996


                              ITEMS IN FORM 10-QSB


                                                                 Page
Facing page

Part I

         Item 1.  Financial Statements.                             1

         Item 2.  Plan of Operation.                               11

Part II

         Item 1.  Legal Proceedings and Claims.                  None

         Item 2.  Changes in Securities.                         None

         Item 3.  Default Upon Senior Securities.                None

         Item 4.  Submission of Matters to                       None
                  a Vote of Security Holders.

         Item 5.  Other Information.                             None

         Item 6.  Exhibits and Reports on Form 8-K.                13

Signatures




<PAGE>   3
                                     PART I

Item 1.  FINANCIAL STATEMENTS

                            ORTEC INTERNATIONAL, INC.
                        (A DEVELOPMENT STAGE ENTERPRISE)
                                 BALANCE SHEETS
                                   (Unaudited)

<TABLE>
<CAPTION>
                                                   SEPTEMBER 30,      DECEMBER 31,
                                                      1996                1995
                                                   -------------        --------
<S>                                                 <C>                 <C>     
            ASSETS

Current assets:
  Cash and equivalents                              $2,535,811          $  2,364
  Other current assets                                      69                57
                                                    ----------          --------
Total current assets                                 2,535,880             2,421
                                                    ----------          --------
Property and equipment, at cost:
  Laboratory equipment                                 531,736           223,888
  Office furniture and equipment                       160,764            54,527
  Construction in progress                                                49,847
  Leasehold improvements                               457,997
                                                    ----------          --------
                                                     1,150,497           328,262
  Accumulated depreciation and
   amortization                                        245,122           171,075
                                                    ----------          --------
                                                       905,375           157,187
                                                    ----------          --------
Other assets:
  Patent application costs                             404,571           369,600
  Deferred offering costs                                                314,697
  Organization costs, net of
   amortization                                                              509
  Deposits                                               6,113             4,056
                                                    ----------          --------
Total other assets                                     410,684           688,862
                                                    ----------          --------
Total Assets                                        $3,851,939          $848,470
                                                    ----------          --------
</TABLE>

See notes to condensed unaudited financial statements.


                                        1
<PAGE>   4
                            ORTEC INTERNATIONAL, INC.
                        (A DEVELOPMENT STAGE ENTERPRISE)
                                 BALANCE SHEETS
                                   (Unaudited)

<TABLE>
<CAPTION>
                                                SEPTEMBER 30,       DECEMBER 31,
                                                    1996                1995
                                                -------------       ------------
<S>                                              <C>                <C>        
   LIABILITIES AND SHAREHOLDERS' EQUITY

Current liabilities:
  Accounts payable and accrued
   liabilities                                   $   445,585        $   790,869
  Current portion of long-term
   liabilities                                        44,851
  Notes payable                                                         515,500
                                                 -----------        -----------
Total current liabilities                            490,436          1,306,369

Long-term liabilities:
  Note payable, less current portion                 459,994
  Obligations under capital leases,
   less current portion                               21,028
  Deferred occupancy costs                                                1,327
                                                 -----------        -----------
Total liabilities                                    971,458          1,307,696
                                                 -----------        -----------
Commitments and contingencies

Stockholders' equity:
  Common stock, $.001 par value;
   authorized, 10,000,000 shares;
   issued and outstanding shares -
   3,623,932 at September 30, 1996 and
   2,408,972 at December 31, 1995                      3,624              2,409
  Additional paid-in capital                       9,622,455          4,749,384
  Deficit accumulated during the
   development stage                              (6,745,598)        (5,211,019)
                                                 -----------        -----------
Total stockholders' equity                         2,880,481           (459,226)
                                                 -----------        -----------
Total Liabilities and
 Stockholders' Equity                            $ 3,851,939        $   848,470
                                                 -----------        -----------
</TABLE>

See notes to condensed unaudited financial statements.


                                        2
<PAGE>   5
                            ORTEC INTERNATIONAL, INC.
                        (A DEVELOPMENT STAGE ENTERPRISE)
                            STATEMENTS OF OPERATIONS
                                   (Unaudited)


<TABLE>
<CAPTION>
                                            Quarter ended                          Nine months              Cumulative from
                                            September 30,                      ended September 30,           March 12, 1991
                                   ------------------------------        ------------------------------      (inception) to
                                       1996               1995               1996               1995       September 30, 1996
                                   -----------        -----------        -----------        -----------    ------------------
<S>                                <C>                <C>                <C>                <C>                <C>        
Revenue
  Interest income                  $    33,865        $        57        $   105,650        $     2,683        $   172,808
                                   -----------        -----------        -----------        -----------        -----------
Expenses
  Research and development             203,720            117,637            591,572            357,792          2,981,124
  Rent                                  48,676              5,433             63,314             16,299            141,187
  Consulting                            24,548                                94,991             38,541            590,754
  Personnel                            198,418             73,261            463,907            208,988          1,608,948
  General and administrative           152,501             40,541            414,389            121,677          1,521,569
  Other expense, net                    10,879                                12,056                                74,824
                                   -----------        -----------        -----------        -----------        -----------
                                       638,742            236,872          1,640,229            743,297          6,918,406
                                   -----------        -----------        -----------        -----------        -----------
Net loss                           $  (604,877)       $  (236,815)       $(1,534,579)       $  (740,614)       $(6,745,598)
                                   -----------        -----------        -----------        -----------        -----------
Net loss per share                 $      (.15)       $      (.09)       $      (.40)       $      (.27)       $     (2.51)
                                   -----------        -----------        -----------        -----------        -----------
Weighted average common and
 common equivalent shares
 outstanding                         3,940,465          2,720,208          3,853,429          2,720,208          2,690,874
                                   -----------        -----------        -----------        -----------        -----------
</TABLE>

See notes to condensed unaudited financial statements.


                                        3
<PAGE>   6
                            ORTEC INTERNATIONAL, INC.
                        (A DEVELOPMENT STAGE ENTERPRISE)
                       STATEMENTS OF SHAREHOLDERS' EQUITY
                                   (Unaudited)

<TABLE>
<CAPTION>
                                                                                                Deficit
                                                                                             accumulated
                                              Common Stock                  Additional          in the
                                     ------------------------------          Paid-in          development
                                        Shares             Amount            Capital             stage              Total
                                     -----------        -----------        -----------        -----------        -----------
<S>                                  <C>                <C>                <C>                <C>                <C>        
Issuance of stock:
 Founders                              1,553,820        $     1,554        $      (684)                          $       870
 First private placement                 217,440                217             64,783                                65,000
 The Director                            149,020                149            249,851                               250,000
 Second private placement                 53,020                 53            499,947                               500,000
 Share issuance expenses                                                       (21,118)                              (21,118)
Net loss for the period from                                                                                     
 March 12, 1991 (inception) to                                                                                   
  December 31, 1991                                                                           $  (281,644)          (281,644)
                                     -----------        -----------        -----------        -----------        -----------
Balance - December 31, 1991            1,973,300              1,973            792,779           (281,644)           513,108

Issuance of stock:
 Second private placement                 49,320                 49            465,424                               465,473
 Stock purchase agreement with                                                                                   
  The Director                            31,820                 32            299,966                               299,998
 Share issuance expenses                                                       (35,477)                              (35,477)
Net loss for the year ended                                                                                      
 December 31, 1992                                                                               (785,941)          (785,941)
                                     -----------        -----------        -----------        -----------        -----------
Balance - December 31, 1992            2,054,440              2,054          1,522,692         (1,067,585)           457,161

Issuance of stock:
 Third private placement                 132,150                132          1,321,368                             1,321,500
 Stock purchase agreement with                                                                                   
  Home Insurance Company                 111,111                111            999,888                               999,999
 Stock purchase agreement with                                                                                   
  The Director                            21,220                 21            199,979                               200,000
 Shares issued in exchange                                                                                       
  for commissions earned                     600                  1              5,999                                 6,000
 Share issuance expenses                                                      (230,207)                             (230,207)
Net loss for the year ended                                                                                      
 December 31, 1993                                                                             (1,445,624)        (1,445,624)
                                     -----------        -----------        -----------        -----------        -----------

Balance - December 31, 1993            2,319,521        $     2,319        $ 3,819,719        $(2,513,209)       $ 1,308,829
                                     -----------        -----------        -----------        -----------        -----------
</TABLE>

See notes to condensed unaudited financial statements.


                                        4
<PAGE>   7
                            ORTEC INTERNATIONAL, INC.
                        (A DEVELOPMENT STAGE ENTERPRISE)
                       STATEMENTS OF SHAREHOLDERS' EQUITY
                                   (Unaudited)

<TABLE>
<CAPTION>
                                                                           Deficit
                                                                          accumulated
                                  Common Stock            Additional        in the
                                 -------------------       Paid-in        development
                                   Shares     Amount       Capital           stage            Total
                                 ---------    ------     -----------      -----------      -----------
<S>                              <C>          <C>        <C>              <C>              <C>        
  (brought forward)              2,319,521    $2,319     $ 3,819,719      $(2,513,209)     $ 1,308,829

Issuance of stock:
 Fourth private placement           39,451        40         397,672                           397,712
 Stock purchase agreement with
  Home Insurance Company            50,000        50         499,950                           500,000
 Share issuance expenses                                      (8,697)                           (8,697)
Net loss for the year ended
 December 31, 1994                                                         (1,675,087)      (1,675,087)
                                 ---------    ------     -----------      -----------      -----------
Balance - December 31, 1994      2,408,972     2,409       4,708,644       (4,188,296)         522,757

Rent forgiveness                                              40,740                            40,740

Net loss for the year ended
 December 31, 1995                                                         (1,022,723)      (1,022,723)
                                 ---------    ------     -----------      -----------      -----------
Balance - December 31, 1995      2,408,972     2,409       4,749,384       (5,211,019)        (459,226)

Issuance of stock:
  Public offering                1,200,000     1,200       5,998,800                         6,000,000
  Exercise of warrants              14,960        15          14,945                            14,960
  Share issuance expenses                                 (1,140,674)                       (1,140,674)
Net loss for the nine months
 ended September 30, 1996                                                  (1,534,579)      (1,534,579)
                                 ---------    ------     -----------      -----------      -----------
Balance - September 30, 1996     3,623,932    $3,624     $ 9,622,455      $(6,745,598)     $ 2,880,481
                                 ---------    ------     -----------      -----------      -----------
</TABLE>

See notes to condensed unaudited financial statements.


                                        5
<PAGE>   8
                            ORTEC INTERNATIONAL, INC.
                        (A DEVELOPMENT STAGE ENTERPRISE)
                            STATEMENTS OF CASH FLOWS
                                   (Unaudited)


<TABLE>
<CAPTION>
                                                                                                  
                                               Quarter ended                   Nine months             Cumulative from   
                                               September 30,               ended September 30,          March 12, 1991   
                                          ------------------------      -------------------------       (inception) to    
                                              1996          1995           1996            1995        September 30, 1996
                                          -----------    ---------      -----------     ---------      ------------------
<S>                                       <C>            <C>            <C>             <C>              <C>           
Cash flows from operating activities:

 Net loss                                 $  (604,877)   $(236,815)     $(1,534,579)    $(740,614)       $  (6,745,598)
 Adjustments to reconcile net loss        
  to net cash used in operating           
  activities:                             
                                          
   Deferred occupancy costs                                 (1,392)          (1,327)       (4,176)
   Depreciation and amortization               44,348       14,433           74,556        43,298              255,360
   Unrealized loss on marketable          
    securities                                                                                                  67,204
   Realized loss on marketable            
    securities                                                                              5,250                5,250
   Changes in operating assets and        
    liabilities                           
     Other current assets                           1           50              (12)        9,247                  (69)
     Accounts payable and accrued         
      liabilities                             108,590       60,190       (  345,284)       95,005              486,325
                                          -----------    ---------      -----------     ---------        -------------
Net cash used in operating                
 activities                                  (451,938)    (163,534)      (1,806,646)     (591,990)          (5,931,528)
                                          -----------    ---------      -----------     ---------        -------------
Cash flows from investing activities:     
                                          
 Purchases of property and equipment         (455,200)     (18,007)        (822,235)      (18,007)          (1,150,497)
 Payments for patent application               (9,969)     (31,599)         (34,971)      (80,566)            (404,571)
 Organization costs                                                                                            (10,238)
 Deposits                                           8                        (2,057)           39               (6,113)
 Purchases of marketable securities                                                          (398)            (594,986)
 Sale of marketable securities                                                            153,561              522,532
                                          -----------    ---------      -----------     ---------        -------------
Net cash (used in) provided by            
 investing activities                        (465,161)     (49,606)        (859,263)       54,629           (1,643,873)
                                          -----------    ---------      -----------     ---------        -------------
</TABLE>
                                     
See notes to condensed unaudited financial statements.


                                        6
<PAGE>   9
                            ORTEC INTERNATIONAL, INC.
                        (A DEVELOPMENT STAGE ENTERPRISE)
                            STATEMENTS OF CASH FLOWS
                                   (Unaudited)


<TABLE>
<CAPTION>
                                            Quarter ended                Nine months              Cumulative from   
                                            September 30,            ended September 30,           March 12, 1991   
                                     ------------------------      -------------------------       (inception) to    
                                         1996          1995            1996           1995        September 30, 1996
                                     -----------    ---------      -----------     ---------      ------------------
<S>                                  <C>            <C>            <C>             <C>               <C>         
Cash flows from financing 
 activities:

 Proceeds from issuance of notes
  payable                            $   302,882    $ 191,000      $   500,000     $ 316,000         $  1,015,500
 Repayment of notes payable               (5,490)                     (520,990)                          (520,990)
 Capitalized leases obligations             (452)                       31,363                             31,363
 Proceeds from issuance of common
  stock                                                              6,014,960                         11,015,512
 Share issuance expenses                                              (825,977)                        (1,430,173)
                                     -----------    ---------      -----------     ---------         ------------
Net cash provided by financing
 activities                              296,940      191,000        5,199,356       316,000           10,111,212
                                     -----------    ---------      -----------     ---------         ------------
Net increase (decrease) in cash         (620,159)     (22,140)       2,533,447      (221,361)           2,535,811

Cash at beginning of period            3,155,970       26,933            2,364       226,154
                                     -----------    ---------      -----------     ---------         ------------
Cash at end of period                $ 2,535,811    $   4,793      $ 2,535,811     $   4,793         $  2,535,811
                                     -----------    ---------      -----------     ---------         ------------
</TABLE>

See notes to condensed unaudited financial statements.


                                        7
<PAGE>   10



                            ORTEC INTERNATIONAL, INC.
                        (A DEVELOPMENT STAGE ENTERPRISE)

                          NOTES TO FINANCIAL STATEMENTS

                           SEPTEMBER 30, 1995 AND 1996


NOTE 1 - FINANCIAL STATEMENTS

         The condensed balance sheet as of September 30, 1996 and the statements
of operations, shareholders' equity and cash flows for the three and nine month
periods ended September 30, 1996 and 1995 and for the period from March 12, 1991
(inception) to September 30, 1996 have been prepared by the Company without
audit. In the opinion of management, all adjustments (which include only normal
recurring accrual adjustments) necessary to present fairly the financial
position, results of operations and cash flows at September 30, 1996 and for all
periods presented have been made. Certain information and footnote disclosure
normally included in the financial statements prepared in accordance with
generally accepted accounting principles have been condensed or omitted. It is
suggested that these condensed financial statements be read in conjunction with
the financial statements and notes thereto in the Company's December 31, 1995
annual report on Form 10-KSB filed with the Securities and Exchange Commission.
The results of operations for the quarter ended September 30, 1996 are not
necessarily indicative of the operating results for the full year.


NOTE 2 - FORMATION OF THE COMPANY AND BASIS OF PRESENTATION

Formation of the Company

         Ortec International, Inc. ("Ortec" or the "Company") was incorporated
in March 1991 as a Delaware corporation to secure and provide funds for the
further development of the technology developed by Dr. Mark Eisenberg of Sydney,
Australia, to replicate in the laboratory, composite cultured skin for use in
skin replacement procedures (the "Technology"). Pursuant to a license agreement
dated September 7, 1991, Dr. Eisenberg has granted Ortec a license for a term of
ten years, which may be automatically renewed by Ortec for two additional
ten-year periods, to commercially use and exploit the Technology for the
development of products, subject to certain limitations. At the expiration or
earlier termination of the agreement, Dr. Eisenberg is entitled to the exclusive
rights in the Technology, and Ortec is entitled to the exclusive rights to all
improvements to the Technology developed during the license period.


                                        8

<PAGE>   11



         The Skin Group, Ltd. (the "Skin Group") also was formed as a Delaware
corporation, in March 1991, to raise funds for development of the Technology. On
July 27, 1992, the Skin Group was merged with and into Ortec. Owners of Skin
Group shares were given .83672 of an Ortec share for each Skin Group share. The
merger was accounted for as if it were a pooling of interests and, accordingly,
the accompanying financial statements include the accounts of Skin Group for all
periods presented.

Basis of Presentation

         The Company is a development stage enterprise, and has neither realized
any operating revenue nor has any assurance of realizing any future operating
revenue. Successful future operations depend upon the successful development and
marketing of the composite cultured skin to be used in skin replacement
procedures.

Initial Public Offering

         On January 19, 1996, the Company completed an initial public offering
("IPO") of 1,200,000 units. Each unit consists of one share of the Company's
common stock, one Class A warrant to purchase one share of common stock at $10,
expiring July 1997 and one Class B warrant to purchase one share of common stock
at $15, expiring January 1999. The Class A and B warrants will be redeemable by
the Company at $.01 per warrant, if the market price of the Company's common
stock equals or exceeds $10 for 10 consecutive trading days during a specified
period, as defined.

         The IPO raised gross proceeds of $6,000,000, of which $800,000,
$515,500 and approximately $341,000 were used to pay underwriting commissions,
notes payable and deferred offering costs, respectively, thereby providing the
Company with net proceeds of approximately $4,343,500. The Company has used and
intends to use the proceeds for continued research and development of composite
cultured skin, performing human clinical trials and general corporate purposes.

1996 Private Placement

         At the end of July 1996 the Company commenced a private placement
offering of shares of its common stock, in multiples of 100 shares only, for up
to $6,000,000 and at a purchase price which is the lower of 80% of the average
closing price of the Company's common stock as quoted on the NASDAQ SmallCap
Market for the five business days ending on (a) the date prior to the day the
purchaser's subscription is received, or (b) the date the sale of such shares is
closed. There was a first closing of shares sold in the private placement
offering at which time the Company sold 332,100 shares at an average price of
$6.53 per share (80% of the average closing prices for the Company's shares

                                        9

<PAGE>   12



in the five-day periods before the subscriptions for these restricted shares
were received) for aggregate gross proceeds of $2,170,224. Out of such gross
proceeds the Company has paid to placement agents in such offering an aggregate
of $148,441 and granted them five-year warrants to purchase an aggregate of
32,360 shares of the Company's common stock at exercise prices of $7.87 per
share (for 30,500 shares) and $7.08 per share (for 1,860 shares) for their
services in the sale of 323,600 shares. $140,056 of such $148,441 was paid to,
and 30,500 of the 32,360 warrants were granted to Mr. Joseph Stechler, a
director of the Company, for his placement of 305,000 shares. The Company has
extended the offering period for such private placement to December 12, 1996.
The Company expects that it will sell more shares in that private placement
offering.

         The Company intends to use the net proceeds it has received and may
continue to receive in such private placement offering for continued research
and development of its composite cultured skin, performing human clinical trials
and for general corporate purposes.

                                       10

<PAGE>   13



ITEM 2.  PLAN OF OPERATION


OPERATIONS FOR THE NEXT TWELVE MONTHS

         For the next twelve months the Company will continue to conduct human
clinical trials. To that end, the Company intends to continue to recruit
hospital burn centers which will provide the necessary patients.

         The Company estimates that the cost to it of each human clinical trial
will be approximately $8,000, which includes testing for pathogens and payments
to the hospital, but does not include any allocation to the cost of such trials
of salaries, rent or other overhead expenses.

         The Company presently employs eleven persons and is in the process of
hiring one more. When the Company's new laboratory in New York City is fully
operational (now expected to be at the end of November 1996), the Company will
initially employ at least two additional persons to work in that laboratory.


CASH REQUIREMENTS

         The Company anticipates that the net proceeds received by it on January
19, 1996 from the public offering of its Common Stock, Class A Warrants and
Class B Warrants and the net proceeds received by it to date from the sale of
its common stock in a private placement offering, will be sufficient to fund its
operations until approximately May 1998. The Company will have to secure
additional funds prior thereto or thereafter to complete its human clinical
trials, if not then already completed, to secure FDA pre-market approval for
commercial sales and thereafter to produce and market its composite cultured
skin in commercial quantities. The private placement offering period has been
extended by the Company to December 12, 1996. The Company expects to sell more
of its shares in such private placement offering.

CLINICAL TRIALS AND PRODUCT RESEARCH AND DEVELOPMENT

         The Company has used and intends to use approximately $1,712,000 of the
net proceeds from the recent public offering and private placement of its
securities to continue the human clinical trials and approximately $3,618,000
for research and development. These amounts include the salaries of its officers
and employees and payments to consultants who will be involved in producing the
composite cultured skin and in research and development and regulatory matters,
payments to members of the Company's Scientific Advisory Board, performing
quality control, securing hospital burn centers to participate in the human

                                       11

<PAGE>   14



clinical trials, monitoring the progress of the patients thereafter and to
prepare reports to be filed with the FDA.


NEW LABORATORY

         In March 1996, the Company entered into a five-year lease with Columbia
University ("Columbia") for 5,765 square feet of space at 3960 Broadway, New
York, New York, in Columbia's new Audubon Biomedical Science and Technology
Park. The Company relocated its executive offices to its new laboratory facility
in July 1996. The Company initially pays rent of $10,809 per month, with
increases in the fourth and fifth years of the lease. The Company granted
Columbia a warrant expiring March 10, 2001, to purchase 5,000 shares of Common
Stock at an exercise price of $10.00 per share. The Company has the option to
renew the lease for an additional five-year term at a modest increase in base
rent. Columbia provided the Company with a $400,000 grant and loaned the Company
$600,000 to construct the new laboratory and office, to pay for architectural
and engineering costs for such construction and for equipment for such new
laboratory. The Company has used and will use approximately $100,000 of its own
funds to purchase the equipment for its new laboratory.

         The Company will use its new laboratory when it is fully operational to
produce its composite cultured skin for use in the remaining FDA approved human
clinical trials and for further research to develop the Company's proprietary
technology for treatment of other wounds. The Company intends to further equip
its new laboratory as a pilot production facility for its composite cultured
skin. Audubon's new center is a dedicated biomedical research facility and the
Company, as a tenant, is entitled to utilize the resources of Columbia
University's Health Sciences Research facility at the Center as well as those at
Columbia University-Presbyterian Medical Center across the street from the
Center.

NUMBER OF EMPLOYEES

         The Company presently employs eleven persons, including its three
executive officers. Only one executive officer is employed on a full time basis.
The Company also retains four consultants. The Company intends to employ at
least three additional full time employees, two when its new laboratory is fully
operational and both of whom will be involved in the clinical trials and in
research and development. The Company expects that it will employ additional
persons as its needs may otherwise require.



                                       12

<PAGE>   15



PART II


ITEM 6.                    EXHIBITS AND REPORTS ON FORM 8-K


(a)      Exhibit No.                Description

           3.1                      Agreement of Merger of the Skin Group, Ltd.
                                    and the Company dated July 9, 1992 (1)

           3.2                      Original Certificate of Incorporation (1)

           3.3                      By-Laws (1)

           4.1                      Form of Certificate evidencing shares of
                                    Common Stock (1)

           4.2                      Form of Underwriter's Option (1)

           4.3                      Form of Warrant Agreement for the public
                                    Class A and Class B Common Stock Purchase
                                    Warrants (1)

           4.4                      Form of Certificate for the public Class A
                                    Common Stock Purchase Warrants filed as
                                    Exhibit A to Exhibit 4.3 (1)

           4.6                      Form of Certificate for public Class B
                                    Warrants filed as Exhibit B to Exhibit 4.3
                                    (1)

           99 (Formerly 28)         FDA approval for human clinical trials (1)

- --------------

(1)     Filed as an Exhibit to the Company's Registration Statement on 
        Form SB-2 (File No. 33-96090), or Amendment 1 thereto, and 
        incorporated herein by reference.

(b)     Reports on Form 8-K

        No reports on Form 8-K were filed during the third quarter of 1996.


                                       13

<PAGE>   16
                                   SIGNATURES


         In accordance with Section 13 or 15(d) of the Exchange Act, the
registrant has caused this report to be signed on its behalf by the undersigned,
thereto duly authorized.

                                                     Registrant:

                                                     ORTEC INTERNATIONAL, INC.



                                                     By:   /s/ Steven Katz
                                                        ------------------------
                                                           President and
                                                      Chief Executive Officer
Dated: November 12, 1996

<TABLE> <S> <C>

<ARTICLE> 5
<LEGEND>
THIS SCHEDULE CONTAINS SUMMARY FINANCIAL INFORMATION EXTRACTED FROM ORTEC
INTERNATIONAL, INC. (A DEVELOPMENT STAGE ENTERPRISE) FINANCIAL STATEMENTS AS
PRESENTED IN THE COMPANY'S FORM 10-QSB FOR THE QUARTER ENDED SEPTEMBER 30, 1996
AND IS QUALIFIED IN ITS ENTIRETY BY REFERENCE TO SUCH FINANCIAL STATEMENTS
</LEGEND>
       
<S>                             <C>
<PERIOD-TYPE>                   9-MOS
<FISCAL-YEAR-END>                          DEC-31-1996
<PERIOD-START>                             JAN-01-1996
<PERIOD-END>                               SEP-30-1996
<CASH>                                       2,535,811
<SECURITIES>                                         0
<RECEIVABLES>                                        0
<ALLOWANCES>                                         0
<INVENTORY>                                          0
<CURRENT-ASSETS>                             2,535,880
<PP&E>                                       1,150,497
<DEPRECIATION>                                 245,122
<TOTAL-ASSETS>                               3,851,939
<CURRENT-LIABILITIES>                          490,436
<BONDS>                                              0
                                0
                                          0
<COMMON>                                         3,624
<OTHER-SE>                                   2,876,857
<TOTAL-LIABILITY-AND-EQUITY>                 3,851,939
<SALES>                                              0
<TOTAL-REVENUES>                               105,650
<CGS>                                                0
<TOTAL-COSTS>                                        0
<OTHER-EXPENSES>                             1,640,229
<LOSS-PROVISION>                                     0
<INTEREST-EXPENSE>                                   0
<INCOME-PRETAX>                            (1,534,579)
<INCOME-TAX>                                         0
<INCOME-CONTINUING>                        (1,534,579)
<DISCONTINUED>                                       0
<EXTRAORDINARY>                                      0
<CHANGES>                                            0
<NET-INCOME>                               (1,534,579)
<EPS-PRIMARY>                                    (.40)
<EPS-DILUTED>                                        0
        

</TABLE>


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