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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 March 31, 1997
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 0-11094
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RIBI IMMUNOCHEM RESEARCH, INC.
(Exact name of registrant as specified in its charter)
Delaware 81-0394349
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(State of Incorporation) (I.R.S. Employer Identification No.)
553 Old Corvallis Road, Hamilton, MT 59840
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(Address of principal executive offices and zip code)
Registrant's telephone number, including area code (406) 363-6214
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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 _____
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As of April 30, 1997, there were 20,001,391 shares of common stock outstanding.
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RIBI IMMUNOCHEM RESEARCH, INC.
INDEX
Page
Number
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PART I. FINANCIAL INFORMATION . . . . . . . . . . . . . . . . . . . . . .3
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Item 1. Financial Statements:
Condensed Balance Sheets
March 31, 1997 (Unaudited)
and December 31, 1996. . . . . . . . . . . . . . . . . . . . . . . .4
Condensed Statements of Operations
Three months ended March 31,
1997 and 1996 (Unaudited). . . . . . . . . . . . . . . . . . . . . .5
Condensed Statements of Cash Flows
Three months ended March 31,
1997 and 1996 (Unaudited). . . . . . . . . . . . . . . . . . . . . .6
Notes to Condensed Financial Statements
(Unaudited). . . . . . . . . . . . . . . . . . . . . . . . . . . . .7
Item 2. Management's Discussion and Analysis
of Financial Condition and Results
of Operations. . . . . . . . . . . . . . . . . . . . . . . . . . . .9
PART II. OTHER INFORMATION. . . . . . . . . . . . . . . . . . . . . . . . 11
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Item 1. Legal Proceedings. . . . . . . . . . . . . . . . . . . . . . . . . 11
Item 6. Exhibits and Reports on Form 8-K . . . . . . . . . . . . . . . . . 11
SIGNATURES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
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2
RIBI IMMUNOCHEM RESEARCH, INC.
PART I. FINANCIAL INFORMATION
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Item 1. Financial Statements
The condensed balance sheet as of March 31, 1997, the condensed statements
of operations and the condensed statements of cash flows for the three-month
periods ended March 31, 1997 and 1996, have been prepared by the Company,
without audit. In the opinion of management, all adjustments necessary to
present fairly the financial position, results of operations and changes in cash
flows as of and for the periods indicated have been made. Certain
reclassifications have been made to the prior year financial statements to
conform to the 1997 presentation.
It is suggested that the accompanying condensed financial statements be
read in conjunction with the audited financial statements and the notes thereto
included in the Company's 1996 Annual Report to Stockholders and Annual Report
on Form 10-K for the fiscal year ended December 31, 1996.
The results of operations for the three month period ending March 31,
1997, are not necessarily indicative of results expected for the full year 1997.
3
RIBI IMMUNOCHEM RESEARCH, INC.
CONDENSED BALANCE SHEETS
(In Thousands)
March 31, December 31,
1997 1996
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(Unaudited)
Assets
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Current assets:
Cash and short-term deposits $ 878 432
Available-for-sale investment securities 16,104 14,080
Trade accounts receivable 66 52
Inventories 1,382 1,268
Other current assets 240 273
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Total current assets 18,670 16,105
Property, plant and equipment, net 11,547 11,601
Other assets, net 588 592
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$ 30,805 28,298
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Liabilities and Stockholders' Equity
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Current liabilities:
Accounts payable $ 169 318
Accrued liabilities 645 570
Deferred revenue 918 563
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Total current liabilities 1,732 1,451
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Stockholders' equity:
Preferred stock - -
Common stock 20 19
Additional paid-in capital 66,479 62,492
Unrealized investment losses (128) (28)
Accumulated deficit (37,298) (35,636)
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Total stockholders' equity 29,073 26,847
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$ 30,805 28,298
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See accompanying notes.
4
RIBI IMMUNOCHEM RESEARCH, INC.
CONDENSED STATEMENTS OF OPERATIONS
(In Thousands Except per Share Data)
(UNAUDITED)
Three Months Ended
March 31,
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1997 1996
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Revenues:
Sales $ 195 300
Contracts and licenses 650 485
Investment income 241 274
Other, net 1 2
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Total revenues 1,087 1,061
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Costs and expenses:
Purchases and production 215 185
Research and development 1,743 1,508
Selling, general and administrative 792 767
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Total costs and expenses 2,750 2,460
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Net loss $ (1,663) (1,399)
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Net loss per common share $ (.08) (.07)
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Average number of shares outstanding 19,729 18,889
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See accompanying notes.
5
RIBI IMMUNOCHEM RESEARCH, INC.
CONDENSED STATEMENTS OF CASH FLOWS
(In Thousands)
(UNAUDITED)
Three Months Ended
March 31,
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1997 1996
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Cash flows from operating activities:
Net loss $ (1,663) (1,399)
Adjustments to reconcile net loss to
cash used by operating activities:
Depreciation and amortization 246 227
Common stock grants 10 1
Compensation relating to stock options 1 -
Discount accretion (39) (69)
Asset sales and abandoned patents - (1)
Changes in operating assets and
liabilities 187 162
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Net cash used by operating activities (1,258) (1,079)
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Cash flows from investing activities:
Capital expenditures (178) (136)
Payments for other assets (24) (20)
Proceeds from maturities of held-to-
maturity investment securities - 1,428
Proceeds from maturities and sales of
available-for-sale investment securities 2,077 425
Purchases of available-for-sale
investment securities (4,162) (3)
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Net cash provided (used) by
investing activities (2,287) 1,694
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Cash flows from financing activities:
Sale of stock, net 3,977 -
Proceeds from exercise of options 14 5
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Net cash provided by financing
activities 3,991 5
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Net change in cash and short-term
deposits 446 620
Cash and short-term deposits at beginning
of period 432 284
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Cash and short-term deposits at end
of period $ 878 904
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See accompanying notes.
6
RIBI IMMUNOCHEM RESEARCH, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(UNAUDITED)
1. Inventories
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Inventories are as follows:
March 31, December 31,
1997 1996
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(In Thousands)
Raw materials $ 81 96
Work in process 1,228 1,092
Finished goods 73 80
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$ 1,382 1,268
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2. Sale of Common Stock
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In January 1997, effective December 31, 1996, SmithKline Beecham ("SB")
purchased 1,103,448 shares of common stock for $4,000,000. SB has the right to
make an additional equity investment of up to $2,000,000, at the then market
price, any time through January 1, 1999. With the stock purchase, SB also
acquired warrants to purchase 500,000 shares of stock at $5.00 per share. The
warrants expire if not exercised by January 1, 2000. Including the 750,608
shares owned by S.R. One limited, a subsidiary of SB, approximately 9.3% of the
Company's outstanding common stock was owned by SB on March 31, 1997.
3. Commitments and Contingencies
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The Company, the National Institutes of Health ("NIH") and the Bitterroot
Valley Sanitary Landfill ("Landfill") were notified by the Montana Department of
Health and Environmental Sciences (now known as the Department of Environmental
Quality ["DEQ"]) in March of 1991 that they had been identified as potentially
responsible parties ("PRPs") and as such are jointly and severally liable for
groundwater contamination located at and near the site of the Landfill in
Ravalli County, Montana. The Company's involvement arises out of waste materials
which it deposited at the Landfill from 1982 to 1985 that the Landfill had
permits to receive. The NIH voluntarily initiated and completed work pursuant to
an interim remediation plan approved by the DEQ to remove and decontaminate the
believed source of the contamination and treat the aquifers which tests have
shown contain contaminants. Although decontamination of the soil at and around
the Landfill has been completed, treatment of the groundwater in the proximity
of the disposal site continues utilizing carbon filtering and air sparging, and
it is anticipated such treatment will continue through 1997 and possibly longer.
The DEQ conducted a "Risk Assessment" and issued a "Draft Final Feasibility
Study" in October 1994 that discussed possible final remediation alternatives.
In August 1995, the DEQ announced that it had approved a second interim action
in the vicinity of the Landfill being voluntarily conducted by the NIH and which
involves installing individual replacement wells and new wells to provide both
an alternate water supply for the affected residents and to develop additional
information on the
7
site hydrogeology. Information collected from these wells through a multi-year
monitoring program will be used by the DEQ to evaluate the effectiveness of the
remediation efforts to date. The current plan calls for the wells to be
installed in three phases: Phase I includes occupied properties with the highest
remaining contamination levels; Phase II includes occupied properties with
lesser degrees of contamination; and Phase III consists largely of vacant
properties. Preliminary studies completed in 1994 estimated the cost of the
wells to be approximately $1,400,000. The first Phase was completed in the
spring of 1996. The DEQ could require the PRPs to implement further remediation
should these wells not provide sufficient quality or quantity of water. The
NIH, which has taken the lead and incurred substantially all of the remediation
costs, has represented publicly that it would continue to work with the DEQ
toward an acceptable final remediation plan. In 1993, the NIH stated that as of
that time, it had incurred costs and anticipated future interim remediation
costs which could total $2 million of more. In 1996 the DEQ filed an action
against the Company, the Landfill and the owner of the Landfill seeking
reimbursement of costs in the amount of $199,000 associated with its oversight
activities. For procedural reasons, the DEQ dismissed this action but recently
re-initiated the action against the Company, the Landfill and the owner of the
Landfill seeking recovery of past alleged costs associated with its oversight
activities in the amount of $238,000, as well as a declaratory judgment finding
the parties liable for future oversight costs, plus civil penalties in the event
the parties fail to comply. The Company is in the process of preparing a
response to the action. Because of these uncertainties, including the
uncertainty of the cost of further remediation and whether the NIH will seek and
obtain partial reimbursement from the other PRPs, it is not possible at this
time to determine the potential liability of the Company as a PRP.
Two landowners in the vicinity of the Landfill have filed civil suits
seeking unspecified damages for alleged diminished value of land, possible
health hazards and loss of domestic water source. The suits name the PRPs and
the DEQ, as well as unknown individuals and corporations which may be discovered
to have contributed to the injuries alleged. The Company filed answers to these
suits denying any liability and in a motion for summary judgment, denied the
injuries alleged. On October 11, 1996, the court granted the summary judgment
and dismissed the plaintiffs' claims. Counsel for one of the plaintiffs filed a
motion for reconsideration, which was denied. Counsel has appealed the District
Court decision to the State Supreme Court on behalf of both plaintiffs. The
Company is preparing a response to the appeal. In addition, Supreme Court rules
require the parties to submit to non-binding mediation prior to the matter being
heard by the Court. The matter is currently in the mediation process. It is
not possible at this time to predict whether additional civil suits will be
filed, the outcome of the pending suits or the potential financial impact on the
Company or the probability of adverse decisions.
As of March 31, 1997, the Company has accrued a reserve of approximately
$190,000 primarily to cover billed and potential legal, consulting and DEQ
reimbursement costs associated with the Company as a PRP and the civil suits.
Some of the costs incurred in the defense of the civil suits, including the
action by the DEQ seeking reimbursement of costs, have been paid by insurance
and at least some of the future defense costs are expected to be paid by
insurance, none of which have been accrued. Net costs charged against operations
during the first quarters of 1997 and 1996 were $1,000 and $7,000, respectively.
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Item 2. Management's Discussion and Analysis of Financial Condition and
Results of Operations
General
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Since its inception in 1981, the Company has been engaged primarily in the
research and development of immunostimulants for use in preventing and treating
human diseases. To date, the Company has received limited revenues from
commercial sales and sales of clinical supplies. The Company has incurred net
losses in each year since its inception and expects to incur additional losses
for at least the next year, and probably longer. At March 31, 1997, the
Company's accumulated deficit was approximately $37,298,000.
The Company's results of operations can vary significantly from quarter to
quarter and depend, among other factors, on costs related to the progress of
clinical trials conducted by the Company and, to a lesser extent, on revenues
and costs associated with manufacturing. To date, research and development
expenses, together with manufacturing costs, have exceeded product and other
revenues in all periods.
The Company is not able to estimate with certainty the amount of cash and
working capital which may be needed for operations. Such requirements typically
vary depending upon the results of basic research and clinical trials, the time
and expense required for governmental approval of products, and competitive and
technical developments, most of which are beyond management's control. There is
no assurance that the Company will be able to obtain the necessary funding in
sufficient amounts or at the appropriate time for its planned activities. In the
event the Company may require additional funding, it might not be able to
proceed as rapidly as it would like, if at all, with the development and
commercialization of its products, which would have a material adverse effect on
its future financial condition and results of operations.
Pursuant to the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995, several forward-looking statements that involve a
number of risks and uncertainties are included within this Management's
Discussion and Analysis of Financial Condition and Results of Operations
including (i) anticipated limited revenues from operations, (ii) anticipated
receipt of milestone and transfer payments from research partners, (iii)
expected levels of research and development spending, and (iv) the Company's
cash requirements. In addition to the risks and uncertainties discussed with
the forward-looking statements, there are a number of other factors that could
cause actual results to differ materially from projected results, including but
not limited to the following: levels of expenditure on and results of the
Company's research and the impact of those results on milestone and transfer
payments from partners, research results of other companies using the Company's
products, competition from other companies, changes in government regulation,
including price controls for newly developed drugs, and risk factors listed from
time-to-time in the Company's SEC reports. Forward-looking statements herein
are followed by an asterisk ("*").
Results of Operations
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During the first quarter of 1997 the Company incurred a net loss of
$1,663,000 compared to a net loss of $1,399,000 in the first quarter of 1996.
The
9
greater net loss reflects slightly higher total revenues and increased expenses,
mainly research and development.
Revenues were higher in the first quarter of 1997 compared to the same
period in 1996, primarily because of increased revenues from license fees. In
January 1997, effective December 31, 1996, the Company entered into a fifth
license agreement with SmithKline Beecham. The agreement grants SB an exclusive
license to use the Company's adjuvants in a human papillomavirus ("HPV")
(genital warts) vaccine, a co-exclusive license for a tuberculosis vaccine and
non-exclusive license to use the Company's adjuvants in the development of
additional infectious disease as well as other vaccines. In addition to annual
license fees, the Company will receive transfer payments for clinical and
commercial quantities of adjuvant and royalties on any commercial sales of
vaccines incorporating the Company's adjuvants.* If the results of further
testing are not favorable or if market conditions change, it is possible that SB
will not develop or sell vaccines for these indications.
Partially offsetting higher license fees, sales were down 35% in the first
quarter of 1997 compared to the first quarter of 1996. The Company is preparing
a commercial license application for MELACINE melanoma theraccine. Part of the
application requires the Company to validate its manufacturing plant and
processes. During the first quarter of 1997, the plant was the subject of the
validation effort and thus, not available to produce material for sale. The
Company believes that sales will increase during the remainder of 1997 over 1996
levels.* However, it is possible that customers will not order or that the
Company may not be able to produce all of the materials it now expects to sell.
Investment income was down approximately 12% in the first quarter of 1997
compared to the same quarter in 1996 due substantially to a reduction in the
amount of invested funds.
Even though sales were lower in the first quarter of 1997 compared to the
first quarter of 1996, purchases and production costs increased during the same
respective periods in 1997 and 1996. The increase in costs in relation to sales
results from lower plant throughput during the first quarter of 1997 due to the
validation effort. As plant throughput increases, the cost per unit should
decrease until plant capacity is reached.* It is possible that material, labor
and other costs will be higher than expected or that throughput will not reach
the levels expected.
Research and development expenses increased 16% during the first quarter
of 1997 over the same quarter in 1996. The Company is conducting a Phase III
human clinical trial using MELACINE therapeutic vaccine with interferon alfa-2b
to treat stage IV (late stage) melanoma patients. Expenses for this trial were
higher in 1997 as the rate of patients being accrued to the trial increased.
The Company is nearing completion of a commercial license application, which it
expects to file in Canada during the second quarter of 1997.* The Company also
plans to file applications in Europe, the United States and Australia later in
the year.* Significant work on the application for Canada did not begin until
the third quarter of 1996 and continued through the first quarter of 1997. It
is possible that completion of the various applications will require more time
than expected or that any or all of the regulatory agencies in the countries
where the applications are filed will not accept the filings for detailed
review. It is also possible that one or all of the applications will not be
approved once accepted for review. Expenses were also higher in the first
quarter of 1997 as
10
the Company continued a dose escalation Phase II(a) safety human clinical trial
and continued preparing for a Phase II(b) controlled human clinical trial in
which cardiac bypass patients are treated prior to surgery with MPL-C
cardioprotectant to prevent or reduce cardiac ischemia reperfusion injury.
Recent preclinical studies have indicated that MPL cardioprotectant can provide
almost immediate protection from ischemia reperfusion injury as opposed to
previous data, which required prophylactic administration of the drug nine to
twelve hours prior to initiation of coronary bypass procedures. This new data
suggests a much more pragmatic approach with broader applications if duplicated
in human studies. Given this new opportunity, the planned Phase II(b) study of
MPL-C by the Cleveland Clinic has not been initiated and the Phase II(a) study
of MPL-C discontinued. Increased research and development expenses in the first
quarter of 1997 were partially offset by charges in the first quarter of 1996
for non-GMP (Good Manufacturing Practices) material manufactured in process
scale-up work in late 1995 and early 1996.
Financial Condition
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During the first quarter of 1997 the Company used $1,258,000 in
operations, which was $179,000 more than was used in the first quarter of 1996.
The increased cash burn in the first quarter of 1997 results primarily from the
increased net loss. The Company expects cash flows used in operations for the
year 1997 to continue to exceed those in the year 1996 as research and
development expenditures are expected to continue higher than they were in 1996
for the remainder of the year.* Projected cash requirements are dependent upon
the Company receiving revenues that are anticipated and conducting the projected
research and clinical trials.
In January 1997, effective December 31, 1996, SB purchased 1,103,448
shares of the Company's common stock for $4,000,000. With this additional
funding, the Company believes its available cash, cash equivalents and
investments together with funds from licensing agreements and product sales
should be sufficient to meet its capital requirements through 1999.* However,
it is possible that revenues from license agreements, product sales and
investments could be lower than anticipated and/or operating costs and expenses
could be higher than anticipated which could result in having sufficient capital
for a period less than through 1999.
See Note 3 of the Notes to Condensed Financial Statements for a discussion
of contingencies related to the Company's identification as a PRP for
groundwater contamination at and near the Bitterroot Valley Sanitary Landfill
and the Company being a named defendant in two civil suits brought by landowners
in the vicinity of the Landfill.
PART II. OTHER INFORMATION
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Item 1. Legal Proceedings
(a) See Note 3 of the Notes to Financial Statements for a discussion of
the Company's involvement as a PRP and a defendant in civil suits
relating to the Bitterroot Valley Sanitary Landfill.
11
Item 6. Exhibits and Reports on Form 8-K
(a) Exhibits
Exhibit 27 - Financial Data Schedule (Filed only electronically)
(b) Reports on Form 8-K
No reports on Form 8-K were filed during the quarter ended
March 31, 1997.
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SIGNATURES
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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.
RIBI IMMUNOCHEM RESEARCH, INC.
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(Registrant)
May 9, 1997 By /s/ Vern D. Child
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Vern D. Child, Vice President-Finance
and Treasurer (duly authorized officer
and principal financial and accounting
officer)
13