1
FORM 10-Q
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20459
[x] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES
EXCHANGE ACT OF 1934
For the quarterly period ended September 30, 1997March 31, 1998
[ ] 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 0-20713
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ENTREMED, INC.
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(Exact name of registrant as specified in its charter)
Delaware 58-1959440
-------- ----------
(State or other jurisdiction of (I.R.S. Employer Identification No.)
incorporation or organization)
Suite 200
9610 Medical Center Drive
Rockville, Maryland
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(Address of principal executive offices)
20850
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(Zip code)
(301) 217-9858
--------------
(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 NO X
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Indicate the number of shares outstanding of each of the issuer's classes of
common stock, as of the most recent practicable date.
Class Outstanding at October 31, 1997May 5, 1998
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----------------------------- --------------------------
Common Stock $.01 Par Value 12,229,76812,428,188
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ENTREMED, INC.
Table of Contents
PART I. FINANCIAL INFORMATION PAGE
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Item 1 -- Financial Statements
Consolidated Balance Sheets
as of September 30, 1997March 31, 1998 and December 31, 19961997 3
Consolidated Statements of
Operations for the Three Months Ended
September 30,March 31, 1998 and 1997 and 1996, and the Nine Months
Ended September 30, 1997 and 1996 4
Consolidated Statements of Cash
Flows for the NineThree Months Ended September 30,March 31, 1998
and 1997
and 1996 5
Notes to Consolidated Financial
Statements 6
Item 2 -- Management's Discussion and Analysis
of Financial Condition and Results of
Operations 8
Part II. OTHER INFORMATION
Item 1 -- Legal Proceedings 1110
Item 2 -- Changes in Securities 1110
Item 3 -- Defaults upon Senior Securities 1110
Item 4 -- Submission of Matters to Vote of
Security Holders 1110
Item 5 -- Other Information 1110
Item 6 -- Exhibits and Reports on Form 8-K 1110
SIGNATURES 1211
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ENTREMED, INC.
CONSOLIDATED BALANCE SHEETS
September 30,March 31, December 31,
1998 1997
1996
----------------- -----------------
ASSETS------------------ ------------------
(unaudited)
ASSETS
Current assets:
Cash and cash equivalents $ 25,946,49226,508,916 $ 33,051,20618,232,491
Short term investments 20,011,850 19,669,62314,860,556 27,012,580
Interest receivable 330,892 401,673
Grant and other406,011 520,457
Accounts receivable 28,586 -289,971 84,151
Prepaid expenses 137,457 97,96234,733 86,095
----------------- -----------------
Total current assets 46,455,277 53,220,464
----------------- -----------------42,100,187 45,935,774
Furniture and equipment, net 1,442,682 824,559
----------------- -----------------1,458,539 1,498,781
Other assets 402,819 101,316404,127 404,108
----------------- -----------------
Total assets $ 48,300,77843,962,853 $ 54,146,33947,838,663
================= =================
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 496,3601,010,856 $ 600,303683,201
Accrued liabilities 417,178 957,718
Capital lease obligations - 104,152918,923 1,265,905
Deferred revenue 1,591,667 2,509,1671,673,131 2,532,297
----------------- -----------------
Total current liabilities 2,505,205 4,171,340
----------------- -----------------3,602,910 4,481,403
Deferred revenue, less current portion 1,711,666 2,236,666
----------------- -----------------1,108,333 1,341,666
Minority Interest 55,048 44,142
----------------- -----------------interest 76,885 62,500
Stockholders' equity:
PreferredConvertible preferred stock, $1.00 par valueand $1.50
Liquidation value:
5,000,000 shares authorized, no sharesnone issued and
outstanding as of September 30, 1997at March 31, 1998 (unaudited)
and December 31, 19961997 - -
Common stock, $.01 par value:
20,000,000 shares authorized, 12,229,76812,372,104 (unaudited)
and 12,009,59812,253,768 shares issued and outstanding as of September 30, 1997at
March 31, 1998 and December 31, 1996,1997, respectively 122,297 120,096123,721 122,538
Additional paid-in capital 73,588,328 72,830,89873,956,662 73,624,088
Accumulated deficit (29,681,766) (25,256,803)(34,905,658) (31,793,532)
----------------- -----------------
Total stockholders' equity 44,028,859 47,694,19139,174,725 41,953,094
----------------- -----------------
Total liabilities and stockholders' equity $ 48,300,77843,962,853 $ 54,146,33947,838,663
================= =================
The accompanying notes are an integral part of the financial statements.
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ENTREMED, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
Three Months Ended
Nine months ended
September 30, September 30,March 31,
1998 1997
1996 1997 1996
------------------------------ -----------------------------------------------------------------
Revenues:
Collaborative research and development $ 1,042,500 $ 1,042,500
$ 3,127,500 $ 3,127,500
Licensing 50,000 50,000
150,000 150,000
Grant revenues 148,54062,471 -
148,540 -
------------- ------------- ------------- ----------------------------- ---------------
Total revenues 1,241,0401,154,971 1,092,500
3,426,040 3,277,500
------------- ------------- ------------- ----------------------------- ---------------
Expenses:
Research & development 2,825,840 2,429,696 6,988,235 5,739,0113,499,431 2,418,835
General & administrative 882,078 721,022 2,851,239 1,964,657
------------- ------------- ------------- ------------
3,707,918 3,150,718 9,839,474 7,703,6681,305,890 746,706
----------------- ---------------
4,805,321 3,165,541
Interest expense - (5,565) (1,418)
(23,755)
InterestInvestment income 663,966 704,247 2,000,795 950,042
------------- ------------- ------------- ------------
Net loss before minority interest (1,802,912) (1,359,536) (4,414,057) (3,499,881)
Minority interest (18,051) (19,551) (10,906) (19,551)
------------- ------------- ------------- ------------538,224 650,952
----------------- ---------------
Net loss $ (1,820,963)(3,112,126) $ (1,379,087) $ (4,424,963) $ (3,519,432)
============= ============= ============= ============(1,423,507)
================= ===============
Net loss per share (basic and diluted) $ (0.15)( 0.25) $ (0.11) $ (0.36) $ (0.39)
============= ============= ============= ============(0.12)
================= ===============
Weighted average number of shares
outstanding 12,219,288 11,993,912 12,132,660 8,994,214
============= ============= ============= ============
Pro forma net loss per share $ (0.35)
============
Pro forma weighted average number
of shares outstanding 10,181,028
============(basic and diluted) 12,300,943 12,044,203
================= ===============
The accompanying notes are an integral part of the financial statements.
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ENTREMED, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
NineThree Months Ended
September 30,March 31,
1998 1997 1996
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CASH FLOWS FROM OPERATING ACTIVITIES
Net loss $ (4,424,963)(3,112,126) $ (3,519,432)(1,423,507)
Adjustments to reconcile net loss to net cash
used by operating activities:
Depreciation and amortization 227,624 151,207
Warrants issued for consulting services 291,000 -185,525 61,709
Minority interest 10,906 19,551Interest 14,385 (2,954)
Changes in assets and liabilities:
Accounts receivable (28,586) 2,399,711(205,820) -
Interest receivable 114,446 36,948
Prepaid Expenses (39,495) (156,800)expenses and other 51,343 56,726
Accounts payable (103,943) 1,043,878327,655 (103,335)
Accrued liabilities (540,540) 500(346,982) 182,067
Deferred revenue (1,442,500) (1,442,499)
Deposits (1,503) (422)
Interest receivable 70,781 (43,748)(1,092,499) (1,092,500)
---------------- ----------------
Net cash used by operating activities (5,981,219) (1,548,054)(4,064,073) (2,284,846)
---------------- ----------------
CASH FLOWS FROM INVESTING ACTIVITIES
Maturities of short-term investments 14,874,72323,100,974 -
Purchases of short-term investments (15,216,950)(10,948,950) (48,894)
Other investments - Investments (300,000) (55,883)
Purchases of furniture & equipment (845,747) (207,985)
----------------(145,283) (116,042)
--------------- ----------------
Net cash usedprovided (used) by investing activities (1,487,974) (263,868)
----------------12,006,741 (464,936)
--------------- ----------------
CASH FLOWS FROM FINANCING ACTIVITIES
Payment of capital lease obligationsobligation - (104,152)
(294,048)
Proceeds from issuanceSales of common stock 468,631 48,666,765333,757 177,650
--------------- ---------------
Net cash provided by financing activities 364,479 48,372,717333,757 73,498
--------------- ---------------
Net increase (decrease) in cash and cash equivalents (7,104,714) 46,560,7958,276,425 (2,676,284)
Cash and cash equivalents at beginning of period 18,232,491 33,051,206 6,885,099
--------------- ---------------
Cash and cash equivalents at end of period $ 25,946,49226,508,916 $ 53,445,89430,374,922
=============== ===============
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION
AND NONCASH INVESTMENT AND FINANCING ACTIVITIES
Interest paid $ 1,418- $ 23,7551,418
=============== ===============
The accompanying notes are an integral part of the financial statements.
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ENTREMED, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER 30, 1997MARCH 31, 1998 (UNAUDITED)
1. BASIS OF PRESENTATION
The accompanying unaudited consolidated financial information of
EntreMed, Inc. (the "Company") includes the accounts of its 85% owned
subsidiary, Cytokine Sciences, Inc. Cytokine Sciences was formed in
June 1996 and was capitalized with $250,000 by EntreMed for the
purpose of acquiring the assets of Innovative Therapeutics, Inc.,
which acquisition was completed in July 1996 in exchange for 15% of
the common stock of Cytokine Sciences, Inc.
The accompanying unaudited consolidated financial statements have been
prepared in accordance with generally accepted accounting principles
for interim financial information and in accordance with the
instructions to Form 10-Q and Article 10 of Regulation S-X.
Accordingly, such consolidated financial statements do not include all
of the information and disclosures required by generally accepted
accounting principles for complete financial statements. In the
opinion of management, all adjustments (consisting of normal recurring
accruals) considered necessary for a fair presentation have been
included. Operating results for the ninethree month period ended September
30, 1997March 31,
1998 are not necessarily indicative of the results that may be
expected for the year ending December 31, 1997.1998. For further
information, refer to the Company's audited financial statements and
footnotes thereto included in the Company's Form 10-K for the year
ended December 31, 1996.1997.
2. NET LOSS PER SHARE
Net loss per share is based on the weighted average number of common
shares outstanding. Pursuant to Securities and Exchange Commission
Staff Accounting Bulletin No. 83, common and convertible preferred
stock issued for consideration below the initial public offering (the
"IPO") price of $15.00 and stock options and warrants issued with
exercise prices below the IPO price during the twelve-month period
preceding the initial filing of the registration statement (commonly
referred to as "Cheap Stock"), have been included in the calculation
of common shares using the treasury stock method through April 12,
1996 in the nine month period ended September 30, 1996, as if they
were outstanding prior to the effective date of the IPO.
The net loss per share amounts for the nine months ended September 30,
1996 as required by generally accepted accounting principles, which
does not give effect to the pro forma conversion of preferred stock
and Cheap Stock described above, or any stock option or warrant common
share equivalents considered antidilutive, is as follows:
Nine months ended
September 30, 1996
Net loss per share $ (0.40)
Weighted average common shares outstanding 8,710,439
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2. NET LOSS PER SHARE (cont.)
Pro forma net loss per common share for the nine month period ended
September 30, 1996 is calculated using the weighted average number of
common shares outstanding, Cheap Stock as described above and assumes
the conversion of the convertible preferred stock at the beginning of
the period.
In February 1997, the Financial Accounting Standards Board ("FASB")
issued Statement of Financial Accounting Standards No. 128, "Earnings
per Share" ("SFASStatement 128"), effective December 1997. SFAS. Statement 128 will requirereplaced the Companypreviously
reported primary and fully diluted earnings per share with basic and
diluted earnings per share. Unlike primary earnings per share, basic
earnings per share excludes any dilutive effect of options, warrants
and convertible securities. Diluted earnings per share is very
similar to present both "basic" and "diluted" lossthe previously reported fully diluted earnings per share.
All earnings per share amounts onfor all periods have been presented,
and where appropriate, restated to conform to the faceStatement 128
requirements
3. COMPREHENSIVE INCOME
In June 1997, the FASB issued Statement No. 130, "Reporting
Comprehensive Income" ("Statement 130"), which establishes standards
for reporting and display of comprehensive income and its components
(revenues, expenses, gains and losses) in financial statements.
Statement 130 is effective for fiscal years beginning after December
15, 1997. The Company adopted Statement 130 in 1998 and has not
presented a statement of comprehensive income because the effect of
the statementcomponents of operations, replacing the
existing net loss per share. Under SFAS 128, basic loss per share
wouldcomprehensive income is not have changed from the reported loss per share of $(0.15) and
$(0.11) for the three month periods ended September 30, 1997 and 1996,
respectively, and $(0.36) for the nine month period ended September
30, 1997. Basic loss per share for the nine month period ended
September 30, 1996 would have been $(0.40). Diluted loss per share
would not have differed from basic loss per share as stock option or
warrant common share equivalents are antidilutive.
3. INITIAL PUBLIC OFFERING
On June 17, 1996, the Company completed an initial public offering of
3,200,000 shares of the Company's common stock at a price of $15.00
per share. Bristol-Myers Squibb Company, a partymaterial to a collaboration
with the Company, also purchased from the Company in a private
placement on the closing of the offering 333,333 shares of the
Company's common stock at $15.00 per share. The initial public
offering resulted in net proceeds to the Company of approximately
$43,500,000 and the private placement with Bristol-Myers Squibb
Company ("BMS") resulted in net proceeds to the Company of an
additional $5,000,000.its
consolidated financial statements.
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4. CONTINGENCIES
The Company is a party to certain litigation fileddefendant in a lawsuit initiated in August 1995 in
the United States District Court for the Eastern District of Tennessee
by Bolling, McCool & Twist ("BMT"), a consulting firm. TheIn the suit,
relatesBMT asserts that the Company breached an agreement between BMT and the
Company by failing to pay BMT certain fees it asserts are owed under
the agreement. More specifically, BMT has asserted a claim for the
payment of services rendered in the approximate amount of $50,000 and
seeks a finder'ssuccess fee in an unspecified amount in connection with the
Bristol-Myers collaboration.BMS Collaboration. The judge in the case bifurcated the proceeding
into two phases: an adjudication of whether the Company breached its
agreement with BMT and then a has been phase. After a trial on the
merits the jury found in favor of BMT on the breach of contract claim.
A trial to determine damages had been scheduled for April 14, 1998.
However, on April 6, 1998, the court issued an Order pursuant to which
damages were limited to those arising during the term of the
Agreement, which terminated on November 1, 1995. Damages for this
period amount to approximately $50,000 plus a possible charge for
interest. BMT has filed a motion for reconsideration of the Order of
the Court and the damage portion of the trial has been adjourned
pending the Court's decision on the motion. Despite the jury verdict
on the breach of contract claim and the court's limitation with
respect to damages, the Company is unable to predict with certainty
the eventual outcome of the lawsuit. The Company is
contestingintends to continue
to contest the action vigorously and believes that this proceeding
will not have a material adverse effect on the Company or on its
financial statements,condition, although there can be no assurance that this will
be the case.
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ITEM 2. MANAGEMENT'S DISCUSSIONS AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS.
GENERAL
Since its inception in September 1991, the Company has devoted
substantially all of its efforts and resources to sponsoring and conducting
research and development on its own behalf and through collaborations with
corporate partners and academic research and clinical institutions, and
establishing its facilities and hiring personnel. In December 1995, the
Company entered into a collaboration agreement with Bristol-Myers Squibb
Company ("BMS") in which BMS made an equity investment in the Company and
agreed to pay certain research and development fees and expenses, license fees,
milestone payments, and royalties on net sales, if any. Through September 30,
1997,March 31,
1998, with the exception of license fees and research and development funding
from BMS as well as certain research grants, the Company had not generated any
revenue from operations. The Company anticipates its revenue sources for the
next several years will be limited to research grants and future collaboration
payments from BMS and from other collaborators under arrangements that may be
entered into in the future. The timing and amounts of such revenues, if any,
will likely fluctuate and depend upon the achievement of specified milestones.
RESULTS OF OPERATIONS
Three and Nine Months Ended September 30,March 31, 1998 and March 31, 1997 and September 30, 1996
Revenues increased approximately 14%6% from $1,092,500 for the three
months ended September 30, 1996March 31, 1997 ("19961997 Three Months") to $1,241,000$1,154,971 for the three
months ended September 30, 1997March 31, 1998 ("19971998 Three Months") and approximately
5% from $3,277,500 for the nine months ended September 30, 1996 ("1996 Nine
Months") to $3,426,000 for the nine months ended September 30, 1997 ("1997 Nine Months"). This increase is due to
grant revenue earned under a Small Business Innovative Research program from
the National Institutes of Health which was awarded to the Company in May 1997.
There were no grant revenues during the 19961997 Three Months and 1996 Nine Months. The BMS
collaborative research and development fees relate to the amortization over
five years of a one-time payment of $2,500,000 received in December 1995 and
the amortization of semi-annual payments of $1,835,000 under the BMS
collaboration agreement. The license fee represents the amortization over five
years of a one-time $1,000,000 license fee received in December 1995 under the
BMS collaboration agreement.
Research and development expenses increased by approximately 16%45%
from $2,430,000 in the 1996 Three Months to $2,826,000$2,419,000 in the 1997 Three Months and byto approximately 22% from $5,739,000$3,500,000 in the
1996 Nine Months to $6,988,000
in the 1997 Nine1998 Three Months. Research and development expenditures include sponsored
research payments to academic collaborators, including a $1,000,000 payment to
Children's Hospital in both 1998 and 1997 Three Months; and expenses related to
the Company's internal research programs. The increase in research and
development costs reflects increased efforts in the Company's internal and
sponsored research and product development programs related to its
angiogenesisantiangiogenesis and blood cell permeation technologies. Overall, research
personnel increased from 1823 as of January 1, 1996March 31, 1997 to 3440 as of September 30, 1997.March 31, 1998.
Research and development expenses are expected to continue to increase as the
Company continues to expand its research and development efforts.
General and administrative expenses increased from approximately
$721,000 in the 1996 Three Months to approximately $882,000$747,000 in the 1997 Three Months a 22% increase. Forto approximately $1,306,000 in the 1997 Nine Months general and administrative
expenses were approximately $2,851,000 as compared to $1,965,000 for the 1996
Nine1998 Three
Months, a 45%75% increase. The overall1998 Three Months increase resulted primarily from
the increase in general and
administrative expenses during the 1997 period compared to the comparable
periods of 1996 is a result of the Company incurring additional
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expensescosts associated with being a public company, investigating potential
strategic relationships, and increasing theadding administrative
staff to support the research scientists and collaborative efforts the Company
is conducting. The
1997 Three Monthsconducting, investigating potential strategic relationships, and 1997 Nine Months includes a one time expense of
approximately $400,000 related to certain consultants to the Company, which
includes a non-cash portion related to warrants issued as part of the services
rendered of $291,000. The total number of administrative personnel the Company
has increased fromobtaining
professional services. Interest
8
as of January 1, 1996 to 12 as of September 30, 1997.
Interest income increased to approximately $2,001,000 in the 1997
Nine Months from $950,000 in the 1996 Nine Months. This increase is a result
of the investment of the proceeds received from the BMS collaboration agreement
and the Company's initial public offering in June 1996. During the Three Month
periods, interest 9
income decreased approximately 5%17% from approximately $704,000$651,000 in 19961997 to
approximately $664,000$538,000 in 1997.1998. This decrease in interest income is due to the
reduction of the Company's cash and short term investments as such working
capital components are used to fund the Company's operations.
The minority interest relates to the portion of the income
recognized by Cytokine Sciences that is attributable to the minority
shareholders of Cytokine Sciences.
Liquidity and Capital Resources
At September 30, 1997,March 31, 1998, the Company had cash and cash equivalents of
approximately $25,947,000$26,509,000 and short-term investments of approximately
$20,012,000$14,861,000 with working capital of approximately $43,950,000,$38,497,000, primarily
representing the net proceeds of the Company's initial public offering and
concurrent private placement with BMS in June 1996 together with funds received
under the BMS agreement entered into in December 1995.
The Company's cash resources have been used to finance research and
development, including sponsored research, capital expenditures, including
leasehold improvements to the Company's laboratory facility, and general and
administrative expenses. Over the next several years, the Company expects to
incur substantial additional research and development costs, including costs
related to early-stage research in areas not reimbursed by Bristol-Myers Squibb
Company, preclinical and clinical trials, increased administrative expenses to
support its research and development operations and increased capital
expenditures for various equipment needs and facility improvements.
As of October 31, 1997, theThe Company wasis a party to sponsored research agreements and clinical
trials requiring the Company to fund an aggregate of approximately $4,286,000$3,400,000
through 1999 (including $3,000,000$2,000,000 to Children's Hospital) and license
agreements requiring milestone payments of up to $4,360,000 and additional
payments upon attainment of regulatory milestones.
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BMS is obligated to make additional semi-annual payments to the
Company of $1,835,000 in each of June and December through June 2000 as well as
additional payments in the event certain mostly late-stage regulatory
milestones are achieved. BMS may terminate the collaboration agreement and
return the licensed technology to the Company at any time upon six months
notice, in which event it would have no further funding obligation to the
Company.
- ------------------------------------------------------
Statements herein that are not descriptions of historical facts are
forward-looking and subject to risk and uncertainties. Actual results could
differ materially from those currently anticipated due to a number of factors,
including those set forth in the Company's Securities and Exchange Commission
filings under "Risk Factors", including risks relating to the early stage of
products under development; uncertainties relating to clinical trials'
dependence on third parties' future capital needs; and risks relating to the
commercialization, if any, of the Company's proposed products (such as
marketing, safety, regulatory, patent, product liability, supply, competition
and other risks).
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PART II. OTHER INFORMATION
Item 1. LEGAL PROCEEDINGS
This information as set forth in Note 4 of "Notes to Condensed Consolidated
Financial Statements" appearing in Item 1 of Part I of this report is
incorporated herein by reference.
Item 2. CHANGES IN SECURITIES
Not applicable.
Item 3. DEFAULT UPON SENIOR SECURITIES
Not applicable.
Item 4. SUBMISSION OF MATTERS TO VOTE OF SECURITY HOLDERS
Not applicable
Item 5. OTHER INFORMATION
Not applicable.
Item 6. EXHIBIT AND REPORTS ON FORM 8-K
(a) The following exhibits are filed with this report:
11 Computation of Earnings Per Share
21 Subsidiaries of the Registrant
27.1 Financial Data Schedule
(b) No reports on Form 8-K were filed by Registrant during the
quarter ended September 30, 1997.March 31, 1998.
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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.
ENTREMED, INC.
(Registrant)
Date: November 12, 1997May 15, 1998 /s/ John W. Holaday
------------------------------------------------------------------------
John W. Holaday, Ph.D.
President and Chief Executive Officer
Date: November 12, 1997May 15, 1998 /s/ R. Nelson Campbell
------------------------------------------------------------------------
R. Nelson Campbell
Chief Financial Officer
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