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[OPHIDIAN PHARMACEUTICALS, INC. LETTERHEAD]
Contact: Donald L. Nevins, CFO
FOR IMMEDIATE RELEASE (PRNEWSWIRE 5:15 PM) Ophidian Pharmaceuticals, Inc.
Phone 608.271.0878
Fax 608.277.2395
E-mail [email protected]
OPHIDIAN PHARMACEUTICALS REPORTS
EXPECTED RESULTS FOR SECOND QUARTER
COMPANY READIES FOR PHASE II TESTING OF ITS LEAD DRUG
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MADISON, Wisconsin (April 16, 1999)--Ophidian Pharmaceuticals, Inc. (NASDAQ
SmallCap: OPHD and Pacific Exchange, Inc.: OPD), a development-stage company,
today reported operating and financial results on target in its second fiscal
quarter of 1999 ended March 31. Douglas C. Stafford, president and chief
executive officer, announced that the financial results reflect the company's
ongoing investment in the clinical development of its lead product, a drug to
treat Clostridium difficile-associated disease ("CDAD"). CDAD is an intestinal
infection that often results from antibiotic use with symptoms ranging from mild
to life threatening. The company continues to focus on expanding the therapeutic
applications of its antibody technology including a drug candidate for treating
inflammatory bowel disease.
"As previously reported, the company continues to evaluate opportunities to form
partnerships with other firms to bring development, manufacturing and marketing
resources to our drug development programs," said Mr. Stafford. Ophidian has
developed extensive drug formulation and manufacturing technology involving over
55 patent applications and 12 issued U.S. patents. The company has focused on
the development of new drugs formulated with antibodies collected from eggs of
specially vaccinated chickens. Ophidian's antibodies are designed to avoid the
complications of antibiotic resistance and the disruption of the beneficial
microbes of the intestinal tract - growing problems of antibiotic use. Phase I
human clinical trials have shown that oral dosing of Ophidian's drug, OPHD001,
is safe and well tolerated in normal persons. The Phase II of testing is
designed to evaluate the safety and various effectiveness parameters of the
OPHD001 in CDAD patients. The company reported today that it has
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established an agreement with Quintiles, Inc. of Arlington, VA, a clinical
research organization ("CRO"), to conduct the initial Phase II testing of
OPHD001. This testing is expected to commence this summer and be completed
around year-end. As previously disclosed, the expected cost to the company is
between $1,500,000 and $1,800,000 on an all-inclusive basis (the CRO's, other
third parties', and the company's direct costs).
The company's annual meeting of shareholders was held on March 23, 1999. The
shareholders voted to: adopt the 1998 incentive stock option plan of Ophidian
Pharmaceuticals, Inc.; to appoint Ernst & Young LLP as independent auditors for
the fiscal year ending September 30, 1999; and to merge Ophidian
Pharmaceuticals, Inc., a Wisconsin corporation, into Ophidian Pharmaceuticals,
Inc., a Delaware corporation. This makes way for the company's reincorporation
in Delaware, a process expected to be completed in the next few weeks. As noted
in the company's proxy statement, it WILL NOT BE NECESSARY for shareholders of
Ophidian Wisconsin to have their stock certificates exchanged for stock
certificates representing the shares of Ophidian Delaware. The common stock and
the common stock purchase warrants of the company are listed for trading on the
Nasdaq SmallCap Market and the Pacific Exchange, Inc. and WILL CONTINUE to be
traded on those markets, without interruption. Delaware law offers corporations
a high degree of predictability and flexibility and can be a significant factor
in attracting and retaining the most capable individuals available to serve as
officers and directors. In addition, Delaware law allows provisions in corporate
charters that give boards of directors greater continuity, stability and
independence, thereby discouraging takeover attempts without negotiation with
boards of directors on behalf of stockholders. Further details are available in
the company's proxy statement.
Following the annual meeting the board elected as nonexecutive chairman Dr.
Peter Model, a senior faculty member at Rockefeller University and a director of
the company since 1996. He takes over as chairman from William Linton, who
retired from the board after 9 years of service as a director and chairman.
In line with expectations, Ophidian's costs for its continuing research and
clinical development caused a net operating loss of $1.2 million in the second
fiscal quarter, compared with a loss of $0.9 million in the prior year's second
quarter. As it is still in the development-stage, it is expected that the
company will continue to report quarterly losses from operations as it supports
the ongoing research, manufacture and clinical testing of its development
products.
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This document may contain certain forward-looking statements based on current
management expectations. There are certain key factors that could cause future
results to differ from those anticipated by management. Such factors include,
but are not limited to, technical risks associated with the development of new
products, the continued progress of clinical trials of the company, the
company's ability to continue to establish collaborative agreements with third
parties, the competitive environment of the biotechnology and pharmaceutical
industries, and general economic conditions. Additional information on potential
factors that could affect the company's financial results are included in the
company's prospectus dated May 7, 1998, and other reports filed with the
Securities and Exchange Commission.
OPHIDIAN PHARMACEUTICALS, INC.
(A DEVELOPMENT STAGE COMPANY)
BALANCE SHEET
$000 OMITTED
<TABLE>
<CAPTION>
SEPT. 30, 1998 MARCH 31, 1999
----------------------------------------
ASSETS (UNAUDITED)
<S> <C> <C>
Total current assets ................................................ $ 8,900 $6,195
Other assets ........................................................ 12 27
Net equipment and leasehold improvements ............................ 1,047 1,162
Patent costs, net of accumulated amortization ....................... 1,395 1,439
------- ------
Total assets ........................................................ $11,354 $8,823
======= ======
LIABILITIES AND SHAREHOLDERS' EQUITY
Total current liabilities ........................................... $ 377 $ 235
Other long term liabilities ......................................... 359 367
Total shareholders' equity .......................................... 10,618 8,221
------- ------
Total liabilities and shareholders' equity .......................... $11,354 $8,823
======= ======
</TABLE>
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OPHIDIAN PHARMACEUTICALS, INC.
(A DEVELOPMENT STAGE COMPANY)
STATEMENTS OF OPERATIONS
$000 OMITTED
(UNAUDITED)
<TABLE>
<CAPTION>
THREE MONTHS ENDED SIX MONTHS ENDED PERIOD FROM INCEPTION
MARCH 31, MARCH 31, (NOVEMBER 11, 1989)
------------------------------- ----------------------------- TO MARCH 31,
1998 1999 1998 1999 1999
---------------- -------------- ---------------- ------------ ---------------------
<S> <C> <C> <C> <C> <C>
Revenues .................................. $ 116 $ 6 $ 231 $ 7 $ 4,602
Operating expenses ..................... 985 1,225 2,007 2,548 19,669
---------------- -------------- ---------------- ------------ ---------------------
Operating loss ............................ (869) (1,219) (1,776) (2,541) (15,067)
Other income .............................. 44 90 89 144 1,218
---------------- -------------- ---------------- ------------ ---------------------
Net loss ............................... $ (825) $(1,129) $(1,687) $(2,397) $(13,849)
================ ============== ================ ============ =====================
Net loss per share ........................ $(0.11) $ (0.12) $ (0.23) $ (0.26)
</TABLE>
OPHIDIAN PHARMACEUTICALS, INC.
(A DEVELOPMENT STAGE COMPANY)
STATEMENTS OF CASH FLOWS
$000 OMITTED
(UNAUDITED)
<TABLE>
<CAPTION>
SIX MONTHS ENDED
MARCH 31, PERIOD FROM INCEPTION
------------------------- (NOVEMBER 11, 1989)
1998 1999 TO MARCH 31,1999
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<S> <C> <C> <C>
OPERATING ACTIVITIES
Net loss .................................................................... $(1,687) $(2,397) $(13,849)
Adjustments to reconcile net loss to net cash used in
operating activities ..................................................... 210 164 1,742
----------------------------------------------------
Net cash used in operating activities ....................................... (1,477) (2,233 (12,107)
INVESTING ACTIVITIES
Purchase of available-for-sale securities ................................ - (4,517)
Proceeds from available-for-sale securities .............................. 113 - 4,416
Purchase of equipment and leasehold improvements, net .................... (112) (284) (1,799)
Expenditures for patents and other activities ............................ (137) (63) (1,517)
----------------------------------------------------
Net cash used in investing activities ....................................... (136) (347) (3,417)
FINANCING ACTIVITIES
Proceeds from issuance of common stock ................................... - - 21,711
Other .................................................................... (390) (4) (83)
----------------------------------------------------
Net cash provided by (used in) financing activities ......................... (390) (4) 21,628
Net increase (decrease) in cash and cash equivalents ........................ (2,003) (2,584) 6,104
----------------------------------------------------
Cash and cash equivalents at beginning of period ............................ 3,547 8,688 -
----------------------------------------------------
Cash and cash equivalents at end of period .................................. $ 1,544 $ 6,104 $ 6,104
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