NEUROBIOLOGICAL TECHNOLOGIES INC /CA/
10QSB, 2000-11-14
BIOLOGICAL PRODUCTS, (NO DIAGNOSTIC SUBSTANCES)
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                                   FORM 10-QSB


                                  UNITED STATES
                        SECURITY AND EXCHANGE COMMISSION
                             Washington, D.C. 20549

(Mark One)

          [X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE
                         SECURITIES EXCHANGE ACT OF 1934

                For the quarterly period ended 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 0-23280

                       NEUROBIOLOGICAL TECHNOLOGIES, INC.
        (exact name of small business issuer as specified in its charter)

                  Delaware                                94-3049219
(State or other  jurisdiction of incorporation (IRS Employer Identification No.)
               or organization)

                           3260 Blume Drive, Suite 500
                           Richmond, California 94806
                    (Address of principal executive offices)

                                 (510) 262-1730
              (Registrant's telephone number, including area code)

  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: Yes [X] No [ ]

  Indicate the number of shares  outstanding of each of the issuer's  classes of
the common stock, as of the latest practical date.

          Common Stock, $.001 Par Value -16,352,640- shares outstanding
                             as of November 3, 2000

  Transitional Small Business Disclosure format    Yes [  ] No [X]


<PAGE>



                                      INDEX

                       NEUROBIOLOGICAL TECHNOLOGIES, INC.


PART I. FINANCIAL INFORMATION

ITEM 1. FINANCIAL STATEMENTS (Unaudited)

         Condensed Balance Sheets - - September 30, 2000 and June 30, 2000

         Condensed Statements of Operations - - Three months ended September 30,
         2000  and  1999;  Period  from  August  27,  1987  (inception)  through
         September 30, 2000

         Condensed Statements of Cash Flows - - Three months ended September 30,
         2000  and  1999;  Period  from  August  27,  1987  (inception)  through
         September 30, 2000

         Notes to Condensed Financial Statements - - September 30, 2000


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


PART II. OTHER INFORMATION

ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K


SIGNATURES


                                       2
<PAGE>


PART 1. FINANCIAL INFORMATION

ITEM 1. FINANCIAL STATEMENTS (Unaudited)

<TABLE>
                                                 NEUROBIOLOGICAL TECHNOLOGIES, INC.
                                                    (A development stage company)
                                                      CONDENSED BALANCE SHEETS
<CAPTION>

                                                                                                  September 30,          June 30,
                                                                                                       2000                2000
                                                                                                   ------------        ------------
                                                                                                    (Unaudited)             (*)
<S>                                                                                                <C>                 <C>
ASSETS

Current assets:
   Cash and cash equivalents                                                                       $  3,786,266        $  7,387,076
   Short-term investments                                                                             3,718,190           1,225,592
   Prepaid expenses and other                                                                            49,260              42,297
                                                                                                   ------------        ------------
      Total current assets                                                                            7,553,716           8,654,965


Long-term investments                                                                                   711,565                --
Property and equipment, net                                                                              45,388              27,778
                                                                                                   ------------        ------------
                                                                                                   $  8,310,669        $  8,682,743
                                                                                                   ============        ============

LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
   Accounts payable and accrued expenses                                                           $    536,003        $    769,393
                                                                                                   ------------        ------------
      Total current liabilities                                                                         536,003             769,393

Stockholders' equity:
   Convertible  preferred stock,  $.001 par value,  5,000,000 shares authorized,
    2,332,000 issued in series, 2,182,000 and 2,282,000 outstanding at September
    30, 2000 and June 30, 2000, respectively                                                          1,091,000           1,141,000
   Common stock, $.001 par value,  25,000,000 shares authorized,  16,311,278 and
    15,647,397 outstanding at September 30, 2000 and
    June 30, 2000, respectively                                                                      42,686,817          42,170,818
   Deferred compensation                                                                               (232,688)           (246,376)
   Deficit accumulated during development stage                                                     (35,770,463)        (35,152,092)
                                                                                                   ------------        ------------

Total stockholders' equity                                                                            7,774,666           7,913,350
                                                                                                   ------------        ------------
                                                                                                   $  8,310,669        $  8,682,743
                                                                                                   ============        ============
<FN>
See accompanying notes
*  Derived from audited financial statements
</FN>
</TABLE>


                                                                 3
<PAGE>



                       NEUROBIOLOGICAL TECHNOLOGIES, INC.
                          (A development stage company)

                       CONDENSED STATEMENTS OF OPERATIONS
                                   (Unaudited)


                                                                   Period from
                                                                 August 27, 1987
                                                                    (inception)
                                 Three months ended September 30,    through
                                   ----------------------------    September 30,
                                       2000            1999            2000
                                   ------------    ------------    ------------
REVENUES
   License                         $       --      $       --      $  2,100,000
   Grant                                   --              --           149,444
                                   ------------    ------------    ------------
      Total revenues                       --              --         2,249,444


EXPENSES
   Research and development             235,597         535,938      27,200,306
   General and administrative           528,671         246,707      13,304,951
                                   ------------    ------------    ------------
      Total expenses                    764,268         782,645      40,505,257
                                   ------------    ------------    ------------

Operating loss                         (764,268)       (782,645)    (38,255,813)
Interest income                         145,897           1,521       2,485,350
                                   ------------    ------------    ------------


NET LOSS                           $   (618,371)   $   (781,124)   $(35,770,463)
                                   ============    ============    ============


BASIC & DILUTED NET
    LOSS PER SHARE                 $      (0.04)   $      (0.10)
                                   ============    ============


Shares used in basic & diluted
  net loss per share calculation     16,103,854       7,690,088
                                    ============    ============


See accompanying notes.


                                       4
<PAGE>
<TABLE>

                                                 NEUROBIOLOGICAL TECHNOLOGIES, INC.
                                                    (A development stage company)

                                                 CONDENSED STATEMENTS OF CASH FLOWS
                                                             (Unaudited)
<CAPTION>

                                                                                                                     Period from
                                                                                     Three months ended            August 27, 1987
                                                                                        September 30,            (inception) through
                                                                             ---------------------------------         September 30,
                                                                                 2000                 1999                2000
                                                                             ------------         ------------         ------------
<S>                                                                          <C>                  <C>                  <C>
OPERATING ACTIVITIES:
Net loss                                                                     $   (618,371)        $   (781,124)        $(35,770,463)
Adjustments to reconcile net loss to net cash used in
operating activities:
   Depreciation and amortization                                                    4,959                  328              649,183
   Amortization of deferred stock compensation                                     13,688                 --                 41,062
   Issuance of common stock and warrants
     for license rights and services                                                 --                   --                209,975
   Changes in assets and liabilities:
     Prepaid expenses and other                                                    (6,963)              (5,558)             (49,260)
     Accounts payable and accrued expenses                                       (233,390)              15,242              536,003
                                                                             ------------         ------------         ------------

Net cash used in operating activities                                            (840,077)            (771,112)         (34,383,500)
                                                                             ------------         ------------         ------------

INVESTING ACTIVITIES:
Purchase of investments                                                        (3,204,163)                --            (38,269,433)
Maturity of investments                                                              --                   --             33,839,678
Purchases of property and equipment                                               (22,569)                --               (411,509)
Additions to patents and licenses                                                    --                   --               (283,062)
                                                                             ------------         ------------         ------------

   Net cash used in investing activities                                       (3,226,732)                --             (5,124,326)

FINANCING ACTIVITIES:
Payment of note payable                                                              --                   --               (200,000)
Proceeds from short-term borrowings                                                  --              1,000,000              435,000
Issuance of common stock, net                                                     465,999              116,740           34,901,010
Issuance of preferred stock, net                                                     --                   --              8,158,082
                                                                             ------------         ------------         ------------

   Net cash provided by financing activities                                      465,999            1,116,740           43,294,092

Increase (decrease) in cash and cash equivalents                               (3,600,810)             345,628            3,786,266

Cash and equivalents at beginning of period                                     7,387,076              201,202                 --
                                                                             ------------         ------------         ------------

Cash and equivalents at end of period                                        $  3,786,266         $    546,830         $  3,786,266
                                                                             ============         ============         ============

SUPPLEMENTAL DISCLOSUSRES:

Conversion of short-term borrowings to
   Series A preferred stock                                                  $       --           $       --           $    235,000
                                                                             ============         ============         ============

Conversion of preferred stock to common stock                                $     50,000         $       --           $  7,302,082
                                                                             ============         ============         ============

Deferred stock compensation related to options
   granted                                                                   $       --           $       --           $    273,750
                                                                             ============         ============         ============
<FN>
See accompanying notes
</FN>
</TABLE>

                                                                 5
<PAGE>



                       NEUROBIOLOGICAL TECHNOLOGIES, INC.
                          (A development stage company)

                     NOTES TO CONDENSED FINANCIAL STATEMENTS
                                   (Unaudited)
                               September 30, 2000

NOTE 1-BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

BASIS OF PRESENTATION

         The accompanying  unaudited  condensed  financial  statements have been
prepared in accordance with generally accepted accounting principles for interim
financial  information and with the  instructions to Form 10-QSB and Item 310(b)
of Regulation S-B.  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 normal recurring  adjustments)  considered  necessary for a fair presentation
have been included. Operating results for the three month period ended September
30, 2000 are not necessarily  indicative of the results that may be expected for
the year ended June 30, 2001.  For further  information,  refer to the financial
statements  and footnotes  included in our Form 10-KSB for the fiscal year ended
June 30, 2000.

BASIC AND DILUTED NET LOSS PER SHARE

         Net loss per share is  presented  under the  requirements  of Financial
Accounting Standards Board ("FAS") No. 128, "Earnings per Share." Basic loss per
share is computed  based on the average shares of common stock  outstanding  and
excludes any options, warrants, and convertible securities. Potentially dilutive
securities,  such as options,  warrants,  and convertible  preferred stock, have
also been excluded from the  computation  of diluted net loss per share as their
effect is antidilutive.

COMPREHENSIVE INCOME (LOSS)

         The  Company  has  no  items  of  other   comprehensive   income,  and,
accordingly, its net loss is equal to its comprehensive income.

NOTE 2-NASDAQ APPROVAL

         In July 2000,  NTI announced  that the company was approved for listing
on The Nasdaq  SmallCap  Market under the ticker symbol NTII. From February 1998
to July 2000, the Company's common stock was traded on the Nasdaq Stock Market's
Over-the-Counter (OTC) Bulletin Board(R).

NOTE 3-SUBSEQUENT EVENTS

         In October  2000,  the Company  received  $2.5  million from Merz + Co.
under its 1998 strategic research and marketing cooperation agreement with Merz.
The payment will be recognized over the term of the agreement.


           MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
                            AND RESULTS OF OPERATIONS

         Statements in this  "Management's  Discussion and Analysis of Financial
Condition and Results of Operations," and elsewhere in this Form 10-QSB that are
not  historical  are  forward-looking  statements and are subject to a number of
risks and  uncertainties  which could cause actual results to differ  materially

                                       6
<PAGE>



from those discussed in the forward-looking statements. Factors that might cause
such a difference include,  but are not limited to, those set forth under "Other
Factors  That May Affect  Our  Operations."  These  forward  looking  statements
represent  NTI's  judgment  as of the date  hereof.  We  disclaim  any intent or
obligation to update these forward looking statements.

OVERVIEW

         Neurobiological Technologies,  Inc. or NTI(R) ("NTI," "we," "us," "our"
or the  "Company")  is an  emerging  drug  development  company  focused  on the
clinical  development and regulatory  approval of neuroscience drugs. We develop
neuroprotective  and  neuromodulatory  agents to treat progressive  neurological
impairments  characteristic  of  various  nervous  system  disorders,  including
diabetic neuropathy,  brain cancer and AIDS Dementia Complex. Our strategy is to
in-license  and develop  early stage drug  candidates  that target major medical
needs and that can be rapidly commercialized.

         NTI currently has two product  candidates that have completed or are in
Phase II  human  clinical  testing.  One of  these,  the  orally-dosed  compound
Memantine,  appears to restore the function of impaired neurons by modulation of
the  N-methyl-D-aspartate  (NMDA)  receptor,  integral to the  membranes of such
cells.  Such  restoration of function  inhibits  injured or damaged neurons from
firing  abnormally,  a pathological  process  associated with many  neurological
conditions,   including   dementia,   Alzheimer's   disease,   neuropathic  pain
(persistent  pain  resulting  from  abnormal  signals  to the  brain)  and  AIDS
dementia.

         In April 1998,  we entered  into a  strategic  research  and  marketing
cooperation  agreement  with  Merz  +  Co.  (Merz)  and a  new  revenue  sharing
partnership with Children's  Medical Center  Corporation to further the clinical
development  and  commercialization  of Memantine.  Pursuant to this  agreement,
Children's Medical Center Corporation terminated its existing license to NTI for
AIDS-related dementia and neuropathic pain and granted exclusive rights to Merz.
NTI and  Merz  share  scientific,  clinical  and  regulatory  information  about
Memantine,  particularly  safety  data,  to  facilitate  regulatory  review  and
marketing  approval by the FDA and foreign regulatory  authorities.  Pursuant to
the  agreement  with  Merz,  NTI will  share in future  revenues  from  sales of
Memantine for all indications.  In that regard,  in October 2000 we received and
expect to continue receiving a share of the payments Merz will receive under its
agreements with Forest Laboratories, Inc. and H. Lundbeck A/S described below.

         In June 2000, Merz entered into an agreement with Forest  Laboratories,
Inc. for the development and marketing of Memantine in the United States for the
treatment of Alzheimer's disease, neuropathic pain and AIDS-related dementia.

         In August 2000,  Merz entered into a strategic  license and cooperation
agreement  with  H.  Lundbeck  A/S,  of  Copenhagen,  Denmark  for  the  further
development and marketing of Memantine for the treatment of Alzheimer's disease,
neuropathic  pain and  AIDS-related  dementia.  Lundbeck will acquire  exclusive
rights to certain European markets and in Canada, Australia and South Africa and
semi-exclusive  rights to co-market  with Merz in other markets  worldwide,  not
including the United States,  which is being  developed by Forest  Laboratories,
and Japan, which is being developed by Merz's collaborative partner Suntory Ltd.

         NTI is also  developing  a second  product,  XERECEPT(TM),  a synthetic
preparation of the natural human peptide,  Corticotropin-Releasing  Factor, as a
treatment for brain swelling due to brain tumors (peritumoral brain edema).

         In August  2000,  we  announced  that we had signed an option  with the
University    of    California,    Berkeley    for    Berkeley's    patents   on
corticotropin-releasing hormone (CRH) analogues. The option agreement includes a
work  plan  that  will  encompass  in vivo  models  of the  hormones  to  screen
CRH-analogues  in terms of  arriving at the optimum  CRH-analogue  for  clinical
purposes.

                                       7
<PAGE>

         Since 1987 when NTI was  founded,  we have  applied a  majority  of our
resources to our research and development  programs.  NTI is a development stage
company,  has not received any revenue  from the sale of products;  however,  we
anticipate  receiving  revenue from the sale of products in the future.  We have
incurred losses since our inception and expect to incur continuing losses due to
ongoing and planned research and development efforts.  However, we have received
and expect to receive income in the form of upfront payments under our agreement
with Merz.  In  addition,  if certain  milestones  are met, we expect to receive
royalties from sales of Memantine.

RECENT EVENT

         On November 1, 2000,  we announced  that we had received a $2.5 million
upfront  payment  from Merz  under our 1998  strategic  research  and  marketing
cooperation agreement with Merz. The payment was triggered by monies received by
Merz pursuant to Merz's agreements with Forest Laboratories and Lundbeck.


RESULTS OF OPERATIONS

         Our  research  and  development  expenses  decreased  to  approximately
$236,000  in the three  months  ended  September  30,  2000  from  approximately
$536,000  in the three  months  ended  September  30,  1999.  The  decrease  was
primarily  due to the  completion  of the  Phase IIB  human  clinical  trials to
evaluate Memantine as a treatment for peripheral  diabetic  neuropathy.  General
and  administrative  expenses  increased to approximately  $529,000 in the three
months ended  September  30, 2000 from  $247,000 in the same period of the prior
year.  The increase was  primarily due to increased  expenditures  in activities
relating to investor  relations  and  corporate  partnerships.  Interest  income
increased to approximately $146,000 in the three months ended September 30, 2000
from  $2,000 in the same  period of the prior  year due to higher  average  cash
balances.

         We expect to incur ongoing  costs  primarily for Phase II and Phase III
clinical  trials for our development of XERECEPT and  CRH-analogues  and related
administrative  support.  We  expect  that our  expenditures  will  continue  to
increase as XERECEPT moves through Phase II and Phase III clinical  trials.  All
future development costs of Memantine will be paid by Merz's marketing partners.

LIQUIDITY AND CAPITAL RESOURCES

         From  inception  through  September 30, 2000, we have raised a total of
$43.1 million in net proceeds from the sale of common and preferred stock.

         We had available cash and cash  equivalents and short-term  investments
of $7.5 million as of September  30, 2000.  We believe that amount plus the $2.5
million  payment we received  from Merz in October 2000 will be adequate to fund
our  operations  through at least the next twelve  months.  In the course of our
development activities we have incurred significant losses and expect additional
losses in the year ending June 30, 200l. We expect to incur costs in fiscal 200l
primarily  for Phase II clinical  trials of XERECEPT and related  administrative
support.  All  future  development  cost of  Memantine  will  be paid by  Merz's
marketing partners.

         Our future  capital  requirements  will  depend on a number of factors,
including:

     o   the amount of front-end  milestone  payments  received  from  marketing
         agreements for Memantine;

     o   the  amount  of  royalties  received  from  Merz  for  future  sales of
         Memantine;

     o   the progress of our clinical development programs;

     o   the time and cost involved in obtaining regulatory approvals;



                                       8
<PAGE>

     o   the cost of filing, prosecuting,  defending and enforcing patent claims
         and other intellectual property rights;

     o   competing technological and market developments;

     o   our ability to establish collaborative relationships; and

     o   the development of commercialization activities and arrangements.

         We may  seek to  raise  additional  funds  whenever  market  conditions
permit. If we are not able to raise adequate funds, we may be required to delay,
scale back,  or  terminate  our  clinical  trials,  or to obtain  funds  through
entering  into  arrangements  with  collaborative   partners  or  others.   Such
arrangements  may  require us to give up  additional  rights to our  technology,
product candidates or products.

OTHER FACTORS THAT MAY AFFECT OUR OPERATIONS

Because all of our potential  products are in clinical  development,  we may not
develop a candidate product that will receive required regulatory approval or be
successfully commercialized.

         We are still in the development stage and have no marketable  products.
As a result,  there is no revenue from product sales,  and most of our resources
are dedicated to the development of selected candidate  pharmaceutical products.
The results of our  preclinical  studies and early stage clinical trials are not
necessarily  indicative  of those that will be obtained  upon  further  clinical
testing  in  later  stage  clinical  trials.  It is  possible  that  none of our
candidate  products  will  receive   regulatory   approval  or  be  successfully
commercialized.

Our  potential  products  are  subject to the risks of failure  inherent  in the
development of products based on new technologies.

         Our potential  products are subject to the risks of failure inherent in
the development of products based on new  technologies.  These risks include the
possibility that the potential products may:

     o   be found to be unsafe, ineffective or toxic;

     o   fail to receive necessary regulatory clearances; and

     o   if  approved,   be  difficult  to  manufacture  on  a  large  scale  or
         uneconomical to market;

     o   be  precluded  from  marketing by us due to the  proprietary  rights of
         third parties; and

     o   not be successful  because third parties market or may market  superior
         or equivalent products.

         Further, our development  activities may not result in any commercially
viable products. We do not expect to be able to commercialize any products for a
number of years, if at all.

We are dependent on Merz and its marketing  partners,  Forest and Lundbeck,  for
the successful commercialization of Memantine.

         The only  revenues that we will receive in the future for Memantine are
royalties on product  sales by Merz or its  marketing  partners and our share of
front-end  and  milestone  payments  received by Merz from its  partners.  Under
certain circumstances,  Merz can terminate its agreement with us upon six months
notice. The termination of our agreement with Merz or any failure by Merz or its
partners to successfully  commercialize  Memantine  after its development  would
have a material adverse effect on our business,  financial condition and results
of operations.

We have relied and will  continue to rely on others for  research,  development,
manufacture and commercialization of our potential products.

         We have entered into various  contractual  arrangements  (many of which
are  non-exclusive)  with  consultants,   academic   collaborators,   licensors,
licensees  and others,  and we are dependent  upon the level of  commitment  and
subsequent    success   of   these   outside   parties   in   performing   their
responsibilities.  Certain of



                                       9
<PAGE>

these agreements place significant  responsibility  for preclinical  testing and
human  clinical  trials  and  for  preparing  and  submitting   submissions  for
regulatory  approval for  potential  products on the  collaborator,  licensor or
contractor.  If the collaborator,  licensor or contractor fails to perform,  our
business may be adversely affected.

         We have also relied on scientific,  technical, clinical, commercial and
other data supplied and  disclosed by others in entering into these  agreements.
We have relied on this data in support of  applications  to enter human clinical
trials for our  potential  products.  Although we have no reason to believe that
this information contains errors or omissions of fact, it is possible that there
are errors or  omissions of fact that would  change  materially  our view of the
future  likelihood  of FDA approval or commercial  viability of these  potential
products.

         We have  agreements  and licenses with third parties that require us to
pay royalties and make other payments to such parties.  Our failure to make such
payments  could  cause us to lose  rights  to  technology  or data  under  these
agreements.  Clinical  trials or marketing of any of our potential  products may
expose us to liability claims from the use of such products, which our insurance
may not cover.

The FDA and state and local  agencies,  and comparable  agencies and entities in
foreign  countries  impose  substantial  requirements on the  manufacturing  and
marketing of human  therapeutics  through  lengthy and detailed  laboratory  and
clinical  testing  procedures,  sampling  activities  and other  costly and time
consuming procedures.

         Fulfillment of regulatory requirements for marketing human therapeutics
typically  takes  many  years  and  varies  substantially  based  on  the  type,
complexity,  and novelty of the drug for which  approval  is sought.  Government
regulation may:

     o   delay for a  considerable  period of time or prevent  marketing  of any
         product that we may develop; and/or

     o   impose costly procedures upon our activities.

         Either  of these  effects  of  government  regulation  may  provide  an
advantage to our competitors.

         There can be no assurance that FDA or other regulatory approval for any
products developed by NTI will be granted on a timely basis or at all. Any delay
in obtaining,  or failure to obtain,  required  approvals would adversely affect
the marketing of our proposed  products and our ability to earn product revenues
or royalties.

         In addition, success in preclinical or early stage clinical trials does
not  assure  success  in later  stage  clinical  trials.  As with any  regulated
product,  additional government  regulations may be instituted which could delay
regulatory approval of our potential products. Additional government regulations
that might result from future  legislation  or  administrative  action cannot be
predicted.

Our success  will  depend,  in large  part,  on our ability to obtain or license
patents,   protect  trade  secrets  and  operate  without  infringing  upon  the
proprietary rights of others.

         The  patent  position  of  biotechnology   firms  generally  is  highly
uncertain because:

     o   patents  involve  complex  legal and factual  issues that have recently
         been the subject of much litigation;

     o   no  consistent  policy has emerged  from the United  States  Patent and
         Trademark  Office regarding the breadth of claims allowed or the degree
         of protection afforded under biotechnology patents; and

     o   others may independently develop similar products, duplicate any of the
         Company's  potential  products,  or  design  around  the  claims of any
         potential patented products of NTI.

                                       10
<PAGE>

         In  addition,  because  of the time  delay in patent  approval  and the
secrecy  afforded  United  States patent  applications,  we do not know if other
applications,  which might have priority over our applications, have been filed.
Further,  because  we have  non-exclusive  licenses  to patent  rights  covering
certain uses of XERECEPT,  others may develop,  manufacture  and market products
that could compete with those we develop.

         As a result of all of these  factors,  there can be no  assurance  that
patent applications  relating to our potential products or processes will result
in patents being issued,  or that patents,  if issued,  will provide  protection
against competitors who successfully challenge our patents,  obtain patents that
may have an adverse  effect on our  ability to conduct  business,  or be able to
circumvent our patent position.

         A number of pharmaceutical and biotechnology companies and research and
academic institutions have developed technologies,  filed patent applications or
received  patents on various  technologies  that may be related to our business.
Some of these  technologies,  applications or patents may conflict with NTI's or
any of our licensors'  technologies or patent applications.  Such conflict could
limit  the  scope of the  patents,  if any,  that we may be able to obtain or to
which we have a license or result in the denial of our  patent  applications  or
the patent applications for which we have licenses. In addition, if patents that
cover our activities have been or are issued to other companies, there can be no
assurance  that we would  be able to  obtain  licenses  to  these  patents  at a
reasonable cost or be able to develop alternative technology.

Because  we do not have our own  manufacturing  facilities,  we face  risks from
outsourcing.

         Memantine   currently  is  being  supplied  to  NTI  by  our  corporate
collaborator, Merz. We have also contracted with external vendors to manufacture
compounds for our other clinical trials.  The manufacturers of clinical products
have  represented  to us that they are  qualified  to  produce  drugs  under FDA
regulations and that they follow current Good Manufacturing Practice (cGMP).

         We face certain risks by outsourcing manufacturing, including:

     o   the  delay  of  our  preclinical  and  human  clinical  testing  if our
         contractors  are  unable to supply  sufficient  quantities  of  product
         candidates manufactured in accordance with cGMP on acceptable terms;

     o   the delay of market  introduction and subsequent sales of such products
         if we should encounter difficulties in establishing  relationships with
         manufacturers to produce, package and distribute our products; and

     o   adverse  effects on the FDA pre-market  approval of the products if our
         collaborators and contract  manufacturers if they do not adhere to cGMP
         regulations.

         Therefore,  our  dependence  on third  parties for the  manufacture  of
products  may  adversely  affect our  results of  operations  and our ability to
develop and deliver products on a timely and competitive basis.

Clinical  trials or marketing of any of our potential  products may expose us to
liability  claims  from the use of such  products  which our  insurance  may not
cover.

         We have a  limited  amount  of  product  liability  insurance  to cover
liabilities   arising  from  clinical  trials.  Our  current  product  liability
insurance does not cover commercial sales of products. We cannot be sure that we
will be able to obtain product liability insurance covering commercial sales or,
if such  insurance is obtained,  that  sufficient  coverage can be acquired at a
reasonable  cost.  An  inability  to  obtain  insurance  at  acceptable  cost or
otherwise  protect against  potential  product liability claims could prevent or
inhibit commercialization of any products we develop.



                                       11
<PAGE>

Further  reductions in our staff might  significantly  delay the  achievement of
planned development objectives.  Each person currently employed by NTI serves an
essential  function.  Any reductions in force could impair our ability to manage
ongoing  human  clinical  trials  and  have a  material  adverse  effect  on our
operations.



                                       12
<PAGE>

                           PART II. OTHER INFORMATION



ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K

         The following  exhibits are  incorporated by reference or filed as part
of this report.

Exhibit
Number            Description
----------        ----------------

3.1               Restated Certificate of Incorporation of the Company. (1)

3.2               Bylaws of the Company. (1)

3.3               Certificate of Designations,  Preferences and Rights of Series
                  A Preferred Stock of the Company. (2)

10.23             Option to Negotiate an Exclusive  License  between the Company
                  and the Regents of the  University of  California,  dated July
                  15, 2000+

27                Financial Data Schedule

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

(1)  This exhibit is filed as an exhibit to the Company's Registration Statement
     on Form SB-2 (Registration No.  33-74118-LA) and is incorporated  herein by
     reference.

(2)  This exhibit is filed as an exhibit to the Company's  Annual Report on Form
     10-KSB  for the year  ended  June 30,  1999 and is  incorporated  herein by
     reference.

+    Confidential  treatment has been requested with respect to certain portions
     of this agreement.  Reports:  The Company did not file a report on Form 8-K
     during the three months ended September 30, 2000.

SIGNATURES

         Pursuant to the  requirements  of the  Securities  and  Exchange Act of
1934,  the  registrant has duly caused this report to be signed on its behalf by
the undersigned thereunto duly authorized.


                                  NEUROBIOLOGICAL TECHNOLOGIES, INC.

Dated: November 14, 2000          /s/ Paul E. Freiman
                                  ----------------------------
                                  Paul E. Freiman
                                  President, Chief Executive Officer
                                  (Principal Executive and Accounting Officer)
                                  and Director


                                       13
<PAGE>

                                  EXHIBIT INDEX

Exhibit
Number            Description
----------        ----------------

3.1               Restated Certificate of Incorporation of the Company. (1)

3.2               Bylaws of the Company. (1)

3.3               Certificate of Designations,  Preferences and Rights of Series
                  A Preferred Stock of the Company. (2)

10.23             Option to Negotiate an Exclusive  License  between the Company
                  and the Regents of the  University of  California,  dated July
                  15, 2000+

27                Financial Data Schedule

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

(1)  This exhibit is filed as an exhibit to the Company's Registration Statement
     on Form SB-2 (Registration No.  33-74118-LA) and is incorporated  herein by
     reference.

(2)  This exhibit is filed as an exhibit to the Company's  Annual Report on Form
     10-KSB  for the year  ended  June 30,  1999 and is  incorporated  herein by
     reference.

+    Confidential  treatment has been requested with respect to certain portions
     of this agreement.


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