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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF
THE SECURITIES EXCHANGE ACT OF 1934
For Quarter Ended: JUNE 30, 1997 Commission File No. 0-19193
CAMBRIDGE NEUROSCIENCE, INC.
----------------------------
(Exact name of registrant as specified in its charter)
DELAWARE 13-3319074
- ------------------------------- --------------------------
(State or other jurisdiction of (I.R.S. Employer I.D. No.)
incorporation or organization)
ONE KENDALL SQUARE, BUILDING 700
CAMBRIDGE, MA 0213
--------------------------------
(Address of principal executive offices including zip code)
617-225-0600
------------
(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
--- ---
At July 31, 1997, 17,821,360 shares of Common Stock, par value $.001 per share,
were issued and outstanding.
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CAMBRIDGE NEUROSCIENCE, INC.
INDEX
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PAGE
PART I - FINANCIAL INFORMATION NUMBER
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ITEM 1 - FINANCIAL STATEMENTS
Condensed Consolidated Balance Sheets
at June 30, 1997 and December 31, 1996 3
Condensed Consolidated Statements of Operations for the
three and six months ended June 30, 1997 and 1996 4 - 5
Condensed Consolidated Statements of Cash Flows
for the six months ended June 30, 1997 and 1996 6
Notes to Condensed Consolidated Financial Statements 7 - 8
ITEM 2 - MANAGEMENT'S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS 8 - 12
PART II - OTHER INFORMATION
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ITEM 4. - SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS 13
ITEM 6 - EXHIBITS AND REPORTS ON FORM 8-K 13
SIGNATURES 14
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CAMBRIDGE NEUROSCIENCE, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except per share data)
JUNE 30, DECEMBER 31,
1997 1996
-------------- ---------------
ASSETS (unaudited)
CURRENT ASSETS
Cash and cash equivalents $34,332 $ 26,664
Marketable Securities 11,575 -
Prepaid expenses and other current assets 1,394 1,271
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TOTAL CURRENT ASSETS 47,301 27,935
Equipment, Furniture and Fixtures, net 936 1,285
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$48,237 $ 29,220
======= =========
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES
Accounts payable and accrued expenses $ 3,949 $ 3,789
Research and development advances 3,841 5,784
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TOTAL CURRENT LIABILITIES 7,790 9,573
STOCKHOLDERS' EQUITY
Preferred stock, par value $.01, 10,000
shares authorized; none issued - -
Common stock, par value $.001, 30,000
shares authorized; 17,801 shares issued
and outstanding at June 30, 1997;
15,010 at December 31, 1996 18 15
Additional paid-in capital 137,630 109,276
Accumulated deficit (97,201) (89,644)
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TOTAL STOCKHOLDERS' EQUITY 40,447 19,647
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$48,237 $ 29,220
======= =========
The accompanying notes are an integral part of the consolidated financial
statements.
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CAMBRIDGE NEUROSCIENCE, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
(unaudited)
THREE MONTHS ENDED JUNE 30,
---------------------------
1997 1996
------------ ---------
Revenues
Research and development $ 1,100 $ 676
Operating expenses
Research and development 5,008 3,290
General and administrative 654 592
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5,662 3,882
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Loss from operations (4,562) (3,206)
Interest income 655 257
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Net loss $(3,907) $(2,949)
======= =======
Net loss per common share $ (0.22) $ (0.22)
======= =======
Number of shares outstanding for purposes of
computing net loss per share 17,789 13,562
======= =======
The accompanying notes are an integral part of the consolidated
financial statements.
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CAMBRIDGE NEUROSCIENCE, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
(unaudited)
SIX MONTHS ENDED JUNE 30,
-------------------------------
1997 1996
----------- ----------
Revenues
Research and development $ 2,194 $ 1,746
Operating expenses
Research and development 9,547 6,366
General and administrative 1,388 1,240
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10,935 7,606
------- -------
Loss from operations (8,741) (5,860)
Interest income 1,184 540
------- -------
Net loss $(7,557) $(5,320)
======= =======
Net loss per common share $ (0.44) $ (0.39)
======= =======
Number of shares outstanding for purposes of
computing net loss per share 17,206 13,554
======= =======
The accompanying notes are an integral part of the consolidated
financial statements.
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CAMBRIDGE NEUROSCIENCE, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
(unaudited)
SIX MONTHS ENDED JUNE 30,
-------------------------
1997 1996
--------- --------
OPERATING ACTIVITIES
Net loss $ (7,557) $(5,320)
Expenses not requiring cash:
Depreciation and amortization 444 522
Common stock issued pursuant to an employee benefit plan 121 77
-------- -------
(6,992) (4,721)
Changes in current assets and liabilities:
Prepaid expenses and other current assets (123) (161)
Accounts payable and accrued expenses 160 (1,211)
Research and development advances (1,943) 2,801
-------- -------
(1,906) 1,429
-------- -------
Cash used for operating activities (8,898) (3,292)
INVESTING ACTIVITIES
Purchase of equipment, furniture and fixtures, net of disposals (95) (125)
Purchase of marketable securities (11,575) -
-------- -------
Cash used for investing activities (11,670) (125)
FINANCING ACTIVITIES
Sales of common stock, net of offering costs and repurchases 28,236 94
-------- -------
Cash provided by financing activities 28,236 94
-------- -------
NET INCREASE/(DECREASE) IN CASH AND CASH EQUIVALENTS 7,668 (3,323)
Cash and cash equivalents at beginning of period 26,664 21,937
-------- -------
CASH AND CASH EQUIVALENTS AT END OF PERIOD $ 34,332 $18,614
======== =======
The accompanying notes are an integral part of the consolidated
financial statements.
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CAMBRIDGE NEUROSCIENCE, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
1. BASIS OF PRESENTATION
---------------------
The accompanying unaudited condensed consolidated financial statements as
of June 30, 1997 and for the three and six month periods ended June 30, 1997 and
1996 have been prepared in accordance with generally accepted accounting
principles for interim financial information and with the instructions to Form
10-Q. 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, the accompanying consolidated
financial statements include all adjustments, consisting of normal recurring
adjustments, necessary for a fair presentation of the financial condition,
results of operations and cash flows for the periods presented. The results of
operations for the interim period ended June 30, 1997 are not necessarily
indicative of the results expected for the full fiscal year.
The consolidated financial statements presented as of December 31, 1996
are derived from the audited financial statements and footnotes included in the
Company's Annual Report on Form 10-K (file number 0-19193).
Cambridge NeuroScience, Inc. (the "Company") is engaged in the
development of proprietary pharmaceuticals to prevent, reduce or reverse damage
caused by severe disorders and injuries of the nervous system.
2. MARKETABLE SECURITIES
---------------------
The Company's policy regarding investments is to ensure safety,
liquidity, and capital preservation while obtaining a reasonable rate of return.
In the second quarter of 1997, the Company broadened its choice of investment
vehicles to include high-grade corporate bonds in an effort to optimize the rate
of return while continuing to ensure the safety and liquidity of its
investments. At June 30, 1997, the Company had $11.6 million invested in
marketable securities with original maturities of greater than 90 days. As the
Company intends that these investments be available for use in the Company's
current operations, these amounts are classified as "available-for-sale" and
included in current assets. Management determines the appropriate classification
of its securities at the time of purchase and reevaluates such classification at
each balance sheet date. Available-for-sale securities are carried at fair
market value and unrealized gains or losses are reported as a separate component
of Stockholders' Equity. Realized gains and losses and declines in value judged
to be other than temporary are included in investment income. The cost of
securities sold is based on the specific identification method. Interest and
dividends earned on these securities are included in investment income. At June
30, 1997, the cost of these investments approximated fair market value.
3. LOSS PER COMMON SHARE
---------------------
Net loss per common share is based on the weighted-average number of
common shares outstanding during each of the periods. Common equivalent shares
from stock options are excluded as their effect is antidilutive.
In February 1997, the Financial Accounting Standards Board issued
Statement No. 128, Earnings Per Share (FAS 128), which will be adopted on
December 31, 1997. FAS 128 requires companies to
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CAMBRIDGE NEUROSCIENCE, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
3. LOSS PER COMMON SHARE, CONTINUED
--------------------------------
change the method currently used to compute earnings per share and to restate
all prior periods for comparability. The adoption of FAS 128 is not expected to
have any impact on the Company's earnings per share due to the fact that the
Company continues to be in a net loss position and, consequently, common
equivalent shares from stock options are excluded as their effect is
antidilutive.
4. RESEARCH AND DEVELOPMENT REVENUE
--------------------------------
The Company recognizes research and development revenue as earned and
such revenue represents reimbursement of the Company's expenditures pursuant to
the terms of two collaboration agreements. Pursuant to the Company's agreement
with Boehringer Ingelheim International GmbH ("BI"), the Company is obligated to
fund 25% of the development expenses for CERESTAT(1) in the United States and
Europe. Revenue earned pursuant to this agreement represents reimbursement by BI
of expenditures by the Company in excess of the 25% required under the
agreement. The Company accounts for research and development revenue from BI
using the percentage of completion method, based on the relationship between
estimated costs incurred to date compared with total estimated costs for the
year. Total estimated costs for the year are reviewed quarterly and revenue
earned in the current period is adjusted for the impact of revisions to the
estimated reimbursable costs. As a result, revenue earned by the Company may
fluctuate on a quarterly basis. Cash received in advance of research and
development performed is designated as research and development advances.
In November 1996, the Company entered into a collaboration agreement with
Allergan, Inc. ("Allergan") for the development of treatments for ophthalmic
disorders, including glaucoma. Pursuant to this agreement, Allergan provides
$1.0 million in research funding per year over a three year period. Revenue
pursuant to this agreement is recognized as payments are received, on a
quarterly basis.
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
RESULTS OF OPERATIONS
THREE MONTHS ENDED JUNE 30, 1997 AND 1996
Revenues
Research and development revenues were $1.1 million for the three month
period ended June 30, 1997, compared to $676,000 in the same period in 1996.
Research and development revenues in the second quarter of 1997 included
$850,000 pursuant to the collaboration agreement with BI, compared to $676,000
in the same period in 1996. This increase reflects an increase in total costs
associated with the ongoing clinical trials of CERESTAT as well as a shift in
the costs incurred by the Company relative to the total costs incurred by both
partners, due to the on-going enrollment of patients in the Phase III traumatic
brain injury trial, managed by the Company, and the suspension of enrollment in
the Phase III stroke trial, managed by BI. On June 24, 1997, the Company and BI
announced the temporary suspension of enrollment of patients into the Phase III
stroke trial, pending the completion of an
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CAMBRIDGE NEUROSCIENCE, INC.
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS, CONTINUED
expanded benefit to risk analysis of all patients enrolled in the trial as of
that date. Revenue pursuant to the BI collaboration agreement represents
reimbursement of the excess of the Company's expenditures over its funding
obligation under the agreement (see Note 4 to the Condensed Consolidated
Financial Statements) and may fluctuate on a quarterly basis. In November 1996,
the Company entered into a collaboration agreement with Allergan. Pursuant to
this agreement, $250,000 was included in research and development revenues for
the second quarter of 1997.
Operating Expenses
Total operating expenses were $5.7 million in the second quarter of 1997,
compared to $3.9 million in the same period in 1996, an increase of $1.8 million
or 46%. Research and development expenses increased by $1.7 million, or 52%, to
$5.0 million in the three months ended June 30, 1997, from $3.3 million in 1996
due primarily to costs associated with increasing patient enrollment in the
Phase III clinical trial of CERESTAT in traumatic brain injury (TBI), which
commenced in the first quarter of 1996. The Company is also incurring increasing
costs associated with preclinical studies of certain of its other product
development programs, as they progress toward clinical trials.
General and administrative expenses increased to $654,000 in the second
quarter of 1997, compared to $592,000 in the same period in 1996, an increase of
$62,000 or 10%. This increase reflects expenses associated with the addition of
a director of marketing in the third quarter of 1996.
Interest Income
Interest income for the three months ended June 30, 1997 was $655,000,
compared to $257,000 for the same period in 1996. This increase is due to higher
cash balances available for investment as a result of an equity investment by BI
in September 1996 as well as the public offering of the Company's Common Stock
in the first quarter of 1997.
Net Loss Per Share
The net loss for the second quarter of 1997 was $3.9 million or $0.22 per
share, compared to $2.9 million or $0.22 per share for the same period in 1996.
The increase in net loss reflects an increase in operating expenses, primarily
for research and development activities, offset in part by an increase in
research and development revenues and interest income. Offsetting the increase
in net loss was an increase in the weighted average shares outstanding as a
result of the sale of 1,237,624 shares of common stock to BI in September 1996
and the public offering of 2,760,000 shares of Common Stock in the first quarter
of 1997.
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CAMBRIDGE NEUROSCIENCE, INC.
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS, CONTINUED
SIX MONTHS ENDED JUNE 30, 1997 AND 1996
Revenues
Research and development revenues were $2.2 million in the six months
ended June 30, 1997, compared to $1.7 million in the same period in 1996.
Research and development revenues recognized pursuant to the BI collaboration
agreement were comparable in both periods, at $1.7 million. Revenues in the
first six months of 1997 also included $500,000 recognized pursuant to the
Allergan collaboration agreement, which commenced in November 1996.
Operating Expenses
Total operating expenses were $10.9 million for the six month period
ended June 30, 1997, compared to $7.6 million for the same period in 1996, an
increase of $3.3 million or 44%. Research and development expenses were $9.5
million in the first half of 1997, compared to $6.4 million in 1996, an increase
of $3.1 million or 50%. This increase is due primarily to increased costs
associated with the on-going Phase III trial of CERESTAT in TBI as well as with
the increasing costs of pre-clinical activities associated with other of the
Company's product development programs, which are progressing toward clinical
trials. An increase in headcount, primarily to support clinical development and
regulatory activities has resulted in an increase in related expenses in 1997
compared to 1996.
General and administrative expenses were $1.4 million in the first half
of 1997, compared to $1.2 million in the same period in 1996, an increase of
$148,000 or 12%. This increase reflects higher costs associated with
pre-marketing activities.
Interest Income
Interest income in the first half of 1997 was $1.2 million, compared to
$540,000 in the first half of 1996. This increase is due to higher cash balances
available for investment as a result of an equity investment by BI in September
1996 and the public offering of the Company's Common Stock in the first quarter
of 1997.
Net Loss Per Share
The net loss for the six months ended June 30, 1997 was $7.6 million, or
$0.44 per share, compared to $5.3 million, or $0.39 per share, in the same
period in 1996. This increase reflects the above mentioned increase in research
and development expenses, offset in part by the revenue earned pursuant to the
Allergan collaboration agreement and higher interest earned on investments.
Partially offsetting the increase in net loss was an increase in the number of
weighted average shares outstanding during the six month period, compared to
1996, as a result of the sale of 1,237,624 shares of common stock to BI in
September 1996 and the public offering of 2,760,000 shares of Common Stock in
the first quarter of 1997.
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CAMBRIDGE NEUROSCIENCE, INC.
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS, CONTINUED
LIQUIDITY AND CAPITAL RESOURCES
The Company had cash and marketable securities of $45.9 million at June
30, 1997, compared to $26.7 million at December 31, 1996. In February 1997, the
Company completed a public offering of 2,760,000 shares of common stock at a
price to the public of $11.00 per share and received net proceeds of $28.1
million. In the first half of 1997, the Company used $8.9 million for operating
purposes.
The Company and BI began two large clinical trials in March (TBI) and
July (stroke) of 1996. The cost of both trials will be shared by the Company and
BI in accordance with the terms of the collaboration agreement. It is expected
that as the number of patients enrolled in the trials increases, total costs for
the trials and the costs borne by the Company will increase. The Company is
obligated to fund 25% of the development costs incurred under the collaboration
agreement in the United States and Europe. BI is required to fund the remaining
75% of such costs and all of the development costs in Japan. Any costs incurred
in excess of one party's contractual obligation will be reimbursed by the other
party. On June 24, 1997, the Company and BI announced the temporary suspension
of enrollment of patients into the Phase III stroke trial, pending the
completion of an expanded benefit to risk analysis of all patients enrolled in
the trial as of that date. The rate of enrollment in the on-going Phase III TBI
trial, which is being managed by Cambridge NeuroScience, has not been affected
by the temporary suspension of the stroke trial. As a result, the amount of
costs being incurred by the Company has increased relative to the total costs
incurred by both partners. Future costs and related revenues associated with the
CERESTAT development program will be dependent in part upon the results of the
expanded interim analysis of data from the stroke trial as well as the progress
of the TBI trial. Therefore, the costs and revenue recognized in the first six
months of 1997 may not be indicative of the results for the full year.
The agreement provides that BI will advance cash to the Company in the
event that it is expected that the Company will spend more than obligated under
the agreement. On an annual basis, actual spending is reconciled with the budget
and may result in the Company's repayment to BI of any excess advances. As of
the most recent cost reconciliation in April 1997, it has been determined that,
as of December 31, 1996, the Company had received approximately $4.9 million in
advances in excess of reimbursement earned. The Company has not received any
cash advances from BI to-date in 1997. The Company expects to repay the prior
year excess advances to BI before the end of 1997.
Pursuant to the agreement signed in November 1996 with Allergan, the
Company may receive up to $3.0 million in research funding through 1999, of
which the Company has received $614,000 as of June 30, 1997. Under the
agreement, Allergan is responsible for the development of potential products and
will bear all of the associated costs.
In December 1996, the Company formed a subsidiary, Cambridge NeuroScience
Partners, Inc. (CNPI), to pursue the development of treatments for Alzheimer's
disease and other neurological disorders. CNPI entered into a collaboration
agreement with the J. David Gladstone Institutes (Gladstone). Pursuant to this
collaboration, Gladstone will conduct a research program over a three year
period, for which CNPI will provide at least $1.25 million in funding per year.
The Company owns 80% of the outstanding stock
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ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS, CONTINUED
of CNPI and has guaranteed CNPI's obligations with respect to its collaboration
with Gladstone.
The Company believes that the existing cash and marketable securities
available at June 30, 1997 will be sufficient to maintain operations through
1998. The BI and Allergan collaboration agreements also provide that the Company
may receive up to an additional $18.0 million and up to an additional $18.5
million, respectively, upon the achievement of certain milestones. However,
there can be no assurance as to when or if these milestones will be achieved.
The Company's primary expenditures are expected to be in the areas of
research and development, general and administrative expenses, and capital
expenditures. The Company will require substantial additional funds for its
research and product development programs, for pursuing regulatory clearances,
for establishing production, sales and marketing capabilities and for other
operating expenses. Despite the potential future milestone payments under the BI
and Allergan agreements, adequate funds for these purposes may not be available
when needed on terms acceptable to the Company, or at all. Insufficient funds
may require the Company to delay, scale back or eliminate certain of its
research and product development programs or to license third parties to
commercialize products or technologies that the Company might otherwise
undertake itself.
The Company does not believe that inflation has had a material impact on
its results of operations.
The discussion contained in this section as well as elsewhere in this
Quarterly Report on Form 10-Q may contain forward-looking statements based on
the current expectations of the Company's management. Such statements are
subject to certain risks and uncertainties which could cause actual results to
differ materially from those projected. There are certain important factors that
could cause results to differ from those anticipated by the statements made
herein, including, but not limited to: the continued funding of the Company's
development program for CERESTAT by BI pursuant to the BI collaboration
agreement; the results of the interim analyses of the phase III clinical trials
of CERESTAT; the rate of enrollment of patients in the Company's current and
future clinical trials and the continuation of enrollment in the Company's Phase
III clinical trial for stroke; the Company's ability to establish and maintain
collaborative arrangements with third parties; technical risks associated with
the development of new products; and the competitive environment of the
biotechnology industry. Readers are cautioned not to place undue reliance on
these forward-looking statements which speak only as of the date hereof. The
Company undertakes no obligation to publicly release the result of any revisions
to these forward-looking statements which may be made to reflect events or
circumstances occurring after the date hereof or to reflect the occurrence of
unanticipated events.
(1) CERESTAT is a registered trademark of Boehringer Ingelheim International
GmbH.
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CAMBRIDGE NEUROSCIENCE, INC.
PART II - OTHER INFORMATION
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ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS.
At the Company's Annual Meeting of stockholders held on Monday, April
28, 1997, the following individuals were elected directors of the Company:
Votes
--------------------------------------------------------------------
Nominee For Against Abstentions Broker Non-Votes
------- --- ------- ----------- ----------------
Nancy S. Amer 14,126,790 9,410 0 2,031,859
Burkhard Blank 14,123,965 12,235 0 2,031,859
Elkan R. Gamzu 14,127,640 8,560 0 2,031,859
Ira A. Jackson 14,123,140 13,060 0 2,031,859
S. Joshua Lewis 13,918,408 217,792 0 2,031,859
Joseph B Martin 14,127,640 8,560 0 2,031,859
Paul C. O'Brien 13,928,890 207,310 0 2,031,859
In addition, the stockholders approved an amendment to the Company's
1992 Director Stock Option Plan to provide that the Board of Directors of the
Company (or a committee authorized by the Board) may, in its discretion, grant
stock options to eligible Directors subsequent and in addition to their initial
automatic grants with a vote of 12,856,747 shares in favor, 1,165,171 shares
against, 39,599 shares abstaining and 2,106,542 broker non-votes, out of
17,782,998 shares outstanding and entitled to vote.
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
(a) Exhibits
27.1 Financial Data Schedule for the interim year-to-date period
ended June 30, 1997 (for electronic filing only)
(b) Reports on Form 8-K
June 24, 1997: News release announcing the temporary suspension of the
Phase III clinical trial of CERESTAT in stroke patients.
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CAMBRIDGE NEUROSCIENCE, INC.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
CAMBRIDGE NEUROSCIENCE, INC.
Date JULY 31, 1997 /s/ ELKAN R. GAMZU
---------------------------- --------------------------------------------
Elkan R. Gamzu
President and Chief Executive Officer
(Principal Executive Officer)
Date JULY 31, 1997 /s/ HARRY W. WILCOX, III
---------------------------- --------------------------------------------
Harry W. Wilcox, III
Senior Vice President, Finance and
Business Development
(Principal Financial and Accounting Officer)
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CAMBRIDGE NEUROSCIENCE, INC.
EXHIBIT INDEX
Exhibit
Number Description
- ------- -----------
27.1 Financial Data Schedule for the interim year-to-date period ended
June 30, 1997 (for electronic filing only)
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