UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
[X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended June 30, 1997
or
[ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Commission File Number: 0-21088
VICAL INCORPORATED
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(Exact name of registrant as specified in its charter)
Delaware 93-0948554
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(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification No.)
9373 Towne Centre Dr., Suite 100, San Diego, California 92121
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(Address of principal executive offices) (Zip code)
(619) 453-9900
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(Registrant's telephone number, including area code)
Not Applicable
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(Former name, former address and former fiscal year, if changed since
last report)
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 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
common stock, as of the latest practicable date.
Class Outstanding at June 30, 1997
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Common Stock, $.01 par value 15,451,161
VICAL INCORPORATED
FORM 10-Q
TABLE OF CONTENTS
PAGE NO.
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COVER PAGE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
TABLE OF CONTENTS. . . . . . . . . . . . . . . . . . . . . . . . . . 2
PART I. FINANCIAL INFORMATION
ITEM 1. Financial Statements
Balance Sheets as of June 30, 1997, and December 31, 1996 . . 3
Statements of Operations for the Three Months Ended June 30,
1997 and 1996, and for the Six Months ended June 30, 1997
and 1996. . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Statements of Cash Flows for the Six Months ended June 30,
1997 and 1996 . . . . . . . . . . . . . . . . . . . . . . . . 5
Notes to Financial Statements . . . . . . . . . . . . . . . . 6
ITEM 2.
Management's Discussion and Analysis of Financial Condition and
Results of Operations . . . . . . . . . . . . . . . . . . . . . . 8
ITEM 3.
Quantitative and Qualitative Disclosure About Market Risk . . . . *
PART II. OTHER INFORMATION
ITEM 1. Legal Proceedings. . . . . . . . . . . . . . . . . . . . *
ITEM 2. Changes in Securities. . . . . . . . . . . . . . . . . . *
ITEM 3. Defaults upon Senior Securities. . . . . . . . . . . . . *
ITEM 4. Submission of Matters to a Vote of Security Holders. . . 11
ITEM 5. Other Information. . . . . . . . . . . . . . . . . . . . *
ITEM 6. Exhibits and Reports on Form 8-K . . . . . . . . . . . . 11
SIGNATURE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
EXHIBIT LIST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
* No information provided due to inapplicability of item.
2
PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
VICAL INCORPORATED
BALANCE SHEETS
June 30, December 31,
1997 1996
(Unaudited)
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ASSETS
Current Assets:
Cash and cash equivalents $ 5,959,523 $ 12,609,277
Marketable securities - available-for-sale 36,402,938 34,237,314
Receivables and other 1,564,293 1,925,995
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Total current assets 43,926,754 48,772,586
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Property and Equipment:
Equipment 4,903,658 4,635,432
Leasehold improvements 1,521,307 1,235,199
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6,424,965 5,870,631
Less-Accumulated depreciation and amortization (4,025,196) (3,607,724)
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2,399,769 2,262,907
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Patent Costs 1,205,649 1,091,687
Deposits and Other Assets 108,924 312,900
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$ 47,641,096 $ 52,440,080
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LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities:
Accounts payable and accrued expenses $ 666,584 $ 810,384
Current portion of capital lease obligations 467,174 455,681
Current portion of notes payable 213,773 -
Deferred revenue 634,782 1,191,304
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Total current liabilities 1,982,313 2,457,369
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Long-Term Obligations:
Notes payable 374,104 641,320
Long-term obligations under capital leases 960,431 976,164
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Total long-term obligations 1,334,535 1,617,484
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Stockholders' Equity:
Common stock, $.01 par value--40,000,000 shares
authorized--15,451,161 and 15,396,582 shares
issued and outstanding at June 30, 1997, and
December 31, 1996, respectively 154,512 153,966
Additional paid-in capital 73,122,113 72,904,472
Unrealized loss on marketable securities (38,795) (48,785)
Accumulated deficit (28,913,582) (24,644,426)
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Total stockholders' equity 44,324,248 48,365,227
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Total Liabilities and Stockholders' Equity $ 47,641,096 $ 52,440,080
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See accompanying notes.
3
VICAL INCORPORATED
STATEMENTS OF OPERATIONS
(UNAUDITED)
Three months ended Six months ended
June 30, June 30,
----------------------------- --------------------------------
1997 1996 1997 1996
----------- ----------- ------------ -----------
Revenues:
Contract revenue $ 393,351 $ 226,228 $ 1,194,926 $ 509,428
License/royalty revenue 473,250 3,329,300 798,130 3,566,587
----------- ----------- ------------ -----------
866,601 3,555,528 1,993,056 4,076,015
Expenses:
Research and development 2,796,978 3,133,421 5,591,412 5,513,839
General and administrative 880,622 738,719 1,777,212 1,469,021
----------- ----------- ------------ -----------
3,677,600 3,872,140 7,368,624 6,982,860
----------- ----------- ------------ -----------
Loss from operations (2,810,999) (316,612) (5,375,568) (2,906,845)
Interest income 597,292 680,036 1,207,369 1,379,052
Interest expense 53,241 13,011 100,957 27,030
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Net income (loss) $(2,266,948) $ 350,413 $ (4,269,156) $(1,554,823)
----------- ----------- ------------ -----------
----------- ----------- ------------ -----------
Net earnings (loss) per share
(Note 2) $ (.15) $ .02 $ (.28) $ (.10)
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Shares used in computing net
earnings (loss) per share
(Note 2) 15,447,949 15,791,282 15,435,491 15,377,166
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----------- ----------- ------------ -----------
See accompanying notes.
4
VICAL INCORPORATED
STATEMENTS OF CASH FLOWS
(UNAUDITED)
Six months ended
June 30,
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1997 1996
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OPERATING ACTIVITIES:
Net loss $ (4,269,156) $(1,554,823)
Adjustments to reconcile net loss to net cash provided from
(used in) operating activities:
Depreciation and amortization 449,207 241,830
Compensation expense related to stock purchases - 103,800
Write-off of abandoned patent application costs - 3,247
Change in operating assets and liabilities:
Receivables and other 361,702 (492,014)
Accounts payable and accrued expenses (143,800) 122,112
Deferred revenue (556,521) 60,326
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Net cash provided from (used in) operating activities (4,158,568) (1,515,522)
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INVESTING ACTIVITIES:
Marketable securities (2,155,634) 1,094,811
Capital expenditures (327,835) (682,071)
Deposits and other assets 203,976 (517,894)
Patent expenditures (132,589) (151,935)
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Net cash provided from (used in) investment activities (2,412,082) (257,089)
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FINANCING ACTIVITIES:
Principal payments under capital lease obligations (243,848) (181,649)
Proceeds from note payable - 641,320
Principal payments on note payable (53,443) -
Issuance of common stock, net 218,187 132,593
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Net cash provided from (used in) financing activities (79,104) 592,264
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Net decrease in cash and cash equivalents (6,649,754) (1,180,347)
Cash and cash equivalents at beginning of period 12,609,277 7,174,128
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Cash and cash equivalents at end of period $ 5,959,523 $ 5,993,781
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Supplemental Disclosure of Non-Cash Investing and Financing Activities:
Equipment acquired under capital leases $ 239,608 $ 144,673
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See accompanying notes.
5
VICAL INCORPORATED
NOTES TO FINANCIAL STATEMENTS
June 30, 1997
(unaudited)
1. ORGANIZATION AND BASIS OF PRESENTATION
ORGANIZATION
Vical was incorporated in April 1987 and has devoted substantially all of
its resources since that time to its research and development programs.
The Company is currently focusing its resources on the development of its
direct gene transfer and related technologies.
BASIS OF PRESENTATION
The information contained herein has been prepared in accordance with
instructions for Form 10-Q. The information at June 30, 1997, and for the
three-month and six-month periods ended June 30, 1997 and 1996, is
unaudited. In the opinion of management, the information reflects all
adjustments necessary to make the results of operations for the interim
periods a fair statement of such operations. All such adjustments are of a
normal recurring nature. Interim results are not necessarily indicative of
results for a full year. The preparation of financial statements in
conformity with generally accepted accounting principles requires
management to make estimates and assumptions that affect the reported
amounts of assets and liabilities and disclosures of contingent assets and
liabilities at the date of the financial statements and the reported
amounts of revenues and expenses during the reporting period. Actual
results could differ from those estimates. For a presentation including
all disclosures required by generally accepted accounting principles, these
financial statements should be read in conjunction with the audited
financial statements for the year ended December 31, 1996, included in the
Vical Incorporated Form 10-K filed with the Securities and Exchange
Commission.
2. NET EARNINGS (LOSS) PER SHARE
Net earnings (loss) per share for the three-month and six-month periods
ended June 30, 1997 and 1996, is computed using the weighted average number
of common shares and dilutive common equivalent shares, as applicable,
outstanding during the period. Common share equivalents represent shares
issuable upon assumed exercise of stock options, using the treasury stock
method, which would have a dilutive effect in periods where there are
earnings. Common equivalent shares are excluded from the calculation of
net loss per share as their effect would be antidilutive. Earnings (loss)
per share on a fully diluted basis are the same as primary earnings (loss)
per share for all periods presented.
In February 1997, the Financial Accounting Standards Board issued Statement
of Financial Accounting Standards No. 128, "Earnings Per Share." The
Company will be required to adopt these new rules effective December 15,
1997. Management does not anticipate any significant impact resulting from
the adoption of this new standard upon current or previously reported
earnings (loss) per share.
6
3. NOTES PAYABLE
In June 1996, the Company entered into a loan and security agreement with
a bank for the borrowing of up to $2,500,000. Borrowings under the line of
credit were secured by substantially all assets of the Company, and the
Company was required to comply with certain financial covenants. In March
1997, the outstanding borrowings converted to a term loan bearing interest
at the bank's prime rate (8.5% at June 30, 1997) plus .5%, or the Company
may alternatively choose to have its outstanding balance bear interest at
the LIBOR rate plus 3.25%. The term loan has a three-year amortization
period. At June 30, 1997, the loan balance was $588,000, including
approximately $214,000 reflected in current liabilities.
4. SUBSEQUENT EVENT
In July 1997, the Company and Pasteur Merieux Connaught ("PMC") began a
Phase I clinical trial of an experimental naked DNA vaccine against
the parasite that causes malaria. The Company and PMC are sponsoring
the trial under their Research, Collaboration and License Agreement.
Pursuant to the agreement with PMC, a payment of $1,000,000 was received
by Vical in July 1997 which will be recorded as revenue in the third
quarter of 1997.
7
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS
OVERVIEW
Vical was incorporated in April 1987 and has devoted substantially all of its
resources since that time to its research and development programs. The
Company is focusing its resources on the development of its direct gene
transfer and related technologies. Currently, the Company is developing its
ALLOVECTIN-7 and LEUVECTIN cancer product candidates internally, while
developing vaccine product candidates for infectious diseases primarily in
collaboration with corporate partners Merck & Co., Inc. ("Merck") and Pasteur
Merieux Connaught ("PMC"). To date, the Company has not received revenues
from the sale of products. The Company expects to incur substantial
operating losses for at least the next several years, due primarily to
expansion of its research and development programs and the cost of
preclinical studies and clinical trials. As of June 30, 1997, the Company's
accumulated deficit was approximately $28.9 million.
In September 1995, the Company commenced Phase II clinical trials of
ALLOVECTIN-7 at 11 teaching oncology centers in five tumor types: melanoma,
colorectal carcinoma, renal cell carcinoma, breast carcinoma and
non-Hodgkin's lymphoma. Treatment of more than 100 patients was completed in
early 1997. Initial results, presented in May 1997, indicated potential
efficacy in certain patients with advanced melanoma. In October 1996, Vical
commenced additional multi-center Phase II clinical testing of ALLOVECTIN-7
in approximately 40 advanced melanoma patients. If appropriate rates and
durations of clinical response are observed in these Phase II clinical
trials, the data could potentially lead to the design and initiation of Phase
II/III clinical trials to support product license approval submissions. In
addition, ALLOVECTIN-7 is being evaluated, either alone or in combination
with approved cancer therapeutic agents, in several other Phase I/II clinical
trials. Initial results from one of these Phase I/II trials, also presented
in May 1997, indicated potential efficacy in certain patients with inoperable
head and neck cancer. A multi-center Phase II trial with ALLOVECTIN-7 in
approximately 20 patients with inoperable head and neck cancer is expected to
begin in the second half of 1997.
In April 1995, the Company initiated Phase I/II clinical testing of its
second gene therapy product candidate, LEUVECTIN, at two clinical centers.
LEUVECTIN is a gene-based product candidate intended for direct injection
into tumor lesions of cancer patients. Upon completion of the trials in
February 1996, the Company concluded that the gene transfer was effective in
the majority of patients, the treatment appeared to be safe and
well-tolerated, and measurable tumor shrinkage was observed in 5 of 23
patients with various types of advanced malignancies. In October 1996, the
Company initiated additional multi-center Phase I/II clinical testing of
higher doses of LEUVECTIN in approximately 45 patients with advanced
melanoma, renal cell carcinoma, or sarcoma. In June 1997, the Company
initiated a Phase I/II clinical trial with LEUVECTIN in approximately 18
prostate cancer patients. Accrual and treatment of patients in the
additional trials were ongoing at June 30, 1997.
In September 1996, Vical entered into a collaboration with Dr. Ronald Levy of
Stanford University Medical Center to develop a naked DNA anti-idiotype
vaccine, VAXID, against low-grade non-Hodgkin's B-cell lymphoma. The Company
believes that immunization of post-chemotherapy patients with VAXID could
result in the elimination of residual disease and the prevention of the
relapse of disease. VAXID is currently under preclinical development and may
enter clinical trials in the second half of 1997.
8
In July 1997, the Company and PMC began a Phase I clinical trial of an
experimental naked DNA vaccine against the parasite that causes malaria. The
Company and PMC are sponsoring the trial under their Research, Collaboration
and License Agreement. The trial is being conducted by the U.S. Naval
Medical Research Institute and the U.S. Army Medical Research Institute of
Infectious Diseases. Pursuant to the agreement with PMC, Vical received a
payment of $1,000,000 in July 1997 which will be recorded as revenue in the
third quarter of 1997.
There can be no assurance that the Company's product candidates will prove to
be safe and effective in clinical trials or that any commercially successful
products will ultimately be developed by the Company.
This Form 10-Q contains, in addition to historical information,
forward-looking statements. When used in this discussion, the words
"expects," "anticipated" and similar expressions are intended to identify
forward-looking statements. Such statements are subject to certain risks and
uncertainties, including whether the Company's product candidates will be
shown to be safe or efficacious in clinical trials, whether the Company's
corporate collaborations will be successful, and whether the Company's
product candidates will ultimately be successfully developed or receive
necessary regulatory approvals and other matters discussed in Item 1 under
the caption "Risk Factors" in the Company's Form 10-K for the year ended
December 31, 1996 filed with the Securities and Exchange Commission , which
could cause actual results to differ materially from those projected. These
forward-looking statements speak only as of the date hereof. The Company
undertakes no obligation to update these forward-looking statements to
reflect events or circumstances after the date hereof or to reflect the
occurrence of unanticipated events.
RESULTS OF OPERATIONS
Revenues of $867,000 were recorded for the quarter ended June 30, 1997,
consisting of license revenue of $329,000 primarily derived from the PMC and
Rhone Merieux agreements, contract revenue of $393,000 from PMC and royalties
amounting to $145,000.. The Company had revenues of $3,555,000 for the
quarter ended June 30, 1996. Revenue in the second quarter of 1996 included
a milestone payment of $1,000,000 as the result of Merck's initiation of a
Phase I clinical trial of an experimental DNA vaccine against influenza under
Merck's research, collaboration and license agreement with Vical covering
potential DNA vaccines. Also included in the second quarter of 1996 was
revenue from the exercise of three of five original license options, the
extension of the option on one of these five vaccine targets, and the
addition of an option to a sixth target by PMC under its agreement with the
Company. Vical received $2.6 million in return for these transactions with
PMC, of which $2,052,000 was recognized as revenue in the second quarter of
1996. Revenue in the second quarter of 1996 also included $328,000 of other
license, contract, and royalty revenue.
Revenues for the six months ended June 30, 1997, were $1,993,000 and, in
addition to contract and license revenue from PMC and Rhone Merieux, and
royalty revenue, included a grant from the Department of Defense of $209,000.
For the six months ended June 30, 1996, revenues were $4,076,000 and
consisted of $1,000,000 from Merck , $2,390,000 from PMC, and other license,
royalty and contract revenue totaling $686,000.
The Company's total operating expenses for the quarter ended June 30, 1997,
were $3,678,000 compared with $3,872,000 for the second quarter of 1996.
Total operating expenses for the six months ended June 30, 1997, were
$7,369,000 compared with $6,983,000 for the same period in 1996.
9
Research and development expenses decreased to $2,797,000 for the three
months ended June 30, 1997, from $3,133,000 for the same period in 1996.
This decrease in research and development expenses was due to higher spending
in 1996 as a result of payments related to license agreements. This decrease
in 1997 due to lower expenses for license agreements was partially offset by
increased research and development activities in 1997. For the six months
ended June 30, 1997, research and development expenses were $5,591,000
compared with $5,514,000 in the same period of 1996.
General and administrative expenses increased to $881,000 for the three
months ended June 30, 1997, from $739,000 for the same period in 1996.
General and administrative expenses for the six months ended June 30, 1997,
increased to $1,777,000 from $1,469,000 for the same period in 1996. The
increase was due primarily to additional staffing and related expenses.
Investment income for the three-month and six-month periods ended June 30,
1997, was $597,000 and $1,207,000, respectively. Investment income for the
three-month and six-month periods ended June 30, 1996, was $680,000 and
$1,379,000, respectively. The decline was a result of lower cash and
investment balances.
The net loss was $.15 per share for the three months ended June 30, 1997,
compared with earnings per share of $.02 for the same period of 1996. For
the six months ended June 30, 1997, the net loss was $.28 per share compared
with a net loss of $.10 per share for the same period in the prior year.
The Company expects to incur losses throughout the remainder of 1997 and to
report a net loss per share for the year ended December 31, 1997.
LIQUIDITY AND CAPITAL RESOURCES
Since its inception, Vical has financed its operations primarily through
private placements of preferred stock, three public offerings of common
stock, and revenues from collaborative agreements. As of June 30, 1997, the
Company had working capital of approximately $41.9 million compared with
$46.3 million at December 31, 1996. Cash and marketable securities totaled
approximately $42.4 million at June 30, 1997, compared with $46.8 million at
December 31, 1996.
The Company expects to incur substantial additional research and development
expense including continued increases in personnel costs and costs related to
preclinical testing and clinical trials. The Company's future capital
requirements will depend on many factors, including continued scientific
progress in its research and development programs, the scope and results of
preclinical testing and clinical trials, the time and costs involved in
obtaining regulatory approvals, the costs involved in filing, prosecuting and
enforcing patent claims, competing technological and market developments, the
cost of manufacturing and scale-up, and commercialization activities and
arrangements. The Company intends to seek additional funding through
research and development relationships with suitable potential corporate
collaborators or through public or private financing. There can be no
assurance that additional funding will be available on favorable terms, if at
all.
If additional funding is not available, Vical anticipates that its available
cash and existing sources of funding will be adequate to satisfy its
operating needs through 1998.
10
PART II. OTHER INFORMATION
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
On June 10, 1997, the Company held its Annual Meeting of Stockholders. The
following actions were taken at the annual meeting.
1. The following Class II directors were elected:
a. Robert C. Bellas, Jr. 13,586,244 shares voted in favor of the
nominee, 544,721 withheld their vote.
b. Dr. M. Blake Ingle. 13,584,216 shares voted in favor of the
nominee, 546,749 withheld their vote.
c. Fred A. Middleton. 13,583,174 shares voted in favor of the nominee,
547,791 withheld their vote.
The Company's Class I directors, Alain B. Schreiber, M.D., and Philip M.
Young, will continue in office until 1999, and the Company's Class III
directors, Patrick F. Latterell, Dale A. Smith and Gary Lyons will continue
in office until 1998.
2. The amendment and restatement of the Company's 1992 stock option plan was
approved. Shares voted for the proposal were 10,056,952, with 4,020,059
shares voted against the proposal and 53,954 shares abstained.
3. The selection of the Company's independent auditors was ratified. Shares
voted in favor of the proposal were 14,019,907, with 92,886 shares voted
against the proposal and 18,172 shares abstained.
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
1. Exhibits
EXHIBIT 27 Financial Data Schedule
2. Reports on Form 8-K
None
11
VICAL INCORPORATED
SIGNATURES
Pursuant to the requirements of the Securities and Exchange Act of 1934, the
registrant has duly caused this report to be signed in its behalf by the
undersigned thereunto duly authorized.
Vical Incorporated
Date: August 11, 1997 By:s/Martha J. Demski
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Martha J. Demski
Vice President and
Chief Financial Officer
(on behalf of the registrant and
as the registrant's Principal
Financial and Accounting
Officer)
12
EXHIBIT
NUMBER DESCRIPTION OF DOCUMENT
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1. EXHIBIT 27 Financial Data Schedule
13