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NVENTA BIOPHARMACEUTICALS CORPORATION
ANNOUNCES SECOND QUARTER 2008 FINANCIAL RESULTS AND RECENT CORPORATE
HIGHLIGHTS
FOR IMMEDIATE RELEASE - August 12, 2008
San Diego, California USA - Nventa Biopharmaceuticals
Corporation (TSX: NVN) announced today financial results for the
second quarter and six months ended June 30, 2008, and highlighted
several recent product developments and corporate milestones.
Recent product and corporate highlights:
- Key clinical results from our Phase 1 trial of HspE7, a therapeutic treatment
for patients with cervical intraepithelial neoplasia, or CIN,
a precursor to cervical cancer:
- Completion of safety and tolerability assessment in Phase 1 trial found
HspE7 to be safe and well tolerated with no serious adverse
events being reported.
- Positive immunological data from the third cohort demonstrated
HPV16 E7-specific T-cell responses were elicited in all patients
following administration of 500 mcg of HspE7 and 1,000 of
Poly-ICLC. All T-cell responses represented significant changes
from baseline, indicating that responses were a direct result
of treatment with HspE7.
- Immunological data from the fourth and final cohort of the
Phase 1 trial demonstrated absolute levels of HPV16 E7-specific
T-cells in patients were similar to levels observed in the
third cohort. Patients in the fourth cohort were administered
500 mcg of HspE7 and 2,000 mcg of Poly-ICLC. These data support
doses of 500 mcg of HspE7 and 1,000-2,000 mcg of Poly ICLC
as appropriate for advancing into Phase 2 studies.
- Appointment of John Varian, chief operating officer and chief
financial officer of ARYx Therapeutics, and Gordon Busenbark,
chief financial officer of Xytis, to Nventa’s board of directors
and audit committee.
- Development of a new proprietary vaccine adjuvant, Poly IC-Poly
Arginine, referred to as Poly-ICR, a potent toll-like receptor
3 (TLR3) agonist, which appears to have broad potential for use
in both therapeutic and prophylactic vaccines. Poly-ICR will be
incorporated into Nventa’s future therapeutic compound programs,
and may be licensed to other vaccine developers worldwide.
- Winning of challenge to our European patent covering the company’s
lead product candidate, HspE7, and other human papillomavirus
(HPV) therapeutics.
“In recent months, Nventa has achieved important clinical milestones
with our lead HspE7 program. Phase 1 clinical findings demonstrated
the immunologic activity of HspE7 in treating CIN, and allowed us
to identify an optimal dosing range as we advance toward Phase 2 development,”
said Gregory M. McKee, president and chief executive officer at Nventa.
“Beyond HspE7, we made an important addition to the Nventa product
pipeline during the quarter with the development of our proprietary
and highly potent adjuvant, Poly-ICR. As this unique TLR3 agonist
may have application in both therapeutic as well as prophylactic vaccines,
it represents a highly valuable asset to the company.”
Second Quarter and Six Months ended June 30, 2008 Financial
Results
All amounts referenced below are in Canadian dollars.
Nventa reported a net loss of $3,930,000, or $0.02 per share, for
the second quarter of 2008,
compared to a net loss of $3,938,000, or $0.02 per share, for the
second quarter of 2007. lthough the company’s net loss was essentially
unchanged in the second quarter of 2008, compared to the second quarter
of 2007, there were significant changes in several income statement
items between the two periods. Research and development expenses increased
by $1,236,000 in the second quarter of 2008, compared to the second
quarter of 2007, principally due to increased clinical development
activities. In addition, collaborative R&D revenue decreased by
$155,000 in the second quarter of 2008, compared to the second quarter
of 2007. These net loss increases, however, were partially offset
by a reduction in foreign exchange losses and SG&A expenses in
the second quarter of 2008, compared to the second quarter of 2007,
and to the absence of restructuring costs in the second quarter of
2008, compared to restructuring costs of $794,000 in the second quarter
of 2007.
Nventa reported a net loss of $5,795,000, or $0.02 per share, for
the six months ended June 30, 2008, compared to a net loss of $7,009,000,
or $0.04 per share, for the same period of 2007. The $1,214,000 decrease
in net loss during the first six months of 2008, compared to the first
six months of 2007, was principally due to lower SG&A, corporate
restructuring and foreign exchange expenses. These reduced expenses
were partially offset by lower collaborative research revenues and
igher R&D expenses during the first six months of 2008, compared
to the same period of 2007.
The company had cash and cash equivalents of $8,069,000 as of June
30, 2008, compared to $12,859,000, as of December 31, 2007.
About Nventa Biopharmaceuticals Corporation:
Nventa is developing innovative therapeutics incorporating our
proprietary CoVal™ fusion technology for the treatment of
viral infections and cancers, with a focus on diseases caused by
the human papillomavirus (HPV); and a Toll-like Receptor 3 (TLR3)
agonist for use as a vaccine adjuvant and as an immunotherapeutic
for viral infections and cancer. The company is publicly traded
on the Toronto Stock Exchange under the symbol "NVN".
For more information about Nventa Biopharmaceuticals Corporation,
please visit the company’s website located at www.nventacorp.com.
The audit committee of the company has reviewed and approved of
the contents of this press release.
Summary financial statements are attached below. The full financial statements and MD&A for the three and six months ended June 30, 2008 can be found on SEDAR at http://www.sedar.com.
This press release contains statements which may constitute forward-looking
information under applicable Canadian securities legislation or forward-looking
statements within the meaning of the United States Private Securities
Litigation Reform Act of 1995. Such forward-looking statements or
information may include financial and other projections as well as
statements regarding the company’s future plans, objectives, performance,
revenues, growth, profits, operating expenses or the company’s underlying
assumptions. The words “may”, “would”, “could”, “will”, “likely”,
“expect,” “anticipate,” “intend”, “plan”, “forecast”, “project”, “estimate”
and “believe” or other similar words and phrases may identify forward-looking
statements or information. Persons reading this press release are
cautioned that such statements or information are only expectations,
and that the company’s actual future results or performance may be
materially different.
Forward-looking statements or information in this press release include,
but are not limited to, statements or information concerning: the
immunologic activity of HspE7 in treating CIN; that we identified
an optimal dosing range for Phase 2 development and that our TLR3
agonist may have application in both therapeutic as well as prophylactic
vaccines.
Such forward-looking statements or information involve known and unknown
risks, uncertainties and other factors that may cause our actual results,
events or developments to be materially different from results, events
or developments expressed or implied by such forward-looking statements
or information. Such factors include, among others, the possibility
that immunologic activity of HspE7 may not treat CIN; the possibility
that immunology responses may not be a predictor of clinical or therapeutic
benefit; our need for capital; the outcomes of our clinical trials;
the possibility that our drug candidate will not treat target diseases
as intended; the possibility that we will not be successful in licensing
our TLR3 agonist to other vaccine developers; risks associated with
requirements for approvals by government agencies such as the FDA
before products can be tested in clinical trials; the possibility
that such government agency approvals will not be obtained in a timely
manner or at all or will be conditioned in a manner that would impair
our ability to advance development; risks associated with the requirement
that a drug candidate be found safe and effective after extensive
clinical trials; our dependence on suppliers, collaborative partners
and other third parties and the prospects and timing for negotiating
supply agreements, corporate collaborations or licensing arrangements;
our ability to attract and retain key personnel; and other factors
as described in detail in our filings with the Canadian securities
regulatory authorities at http:www.sedar.com.
Assumptions underlying our expectations regarding forward-looking
statements or information contained in this press release include,
among others, that HspE7 treats CIN; that immunology responses are
a predictor of clinical and therapeutic benefit; that future clinical
trial results will be favorable; that our drug candidate will treat
target diseases as intended; that we will raise enough capital, on
reasonable terms and in a timely manner; that we will retain our key
personnel; that we will obtain the necessary regulatory approvals
related to HspE7 and our adjuvant in a timely manner and that we will
be able to license our TLR3 agonist.
In the event that any of these assumptions prove to be incorrect,
or in the event that we are impacted by any of the risks identified
above, we may not be able to continue in our business as planned.
For a complete discussion of the assumptions, risks and uncertainties
related to our business, you are encouraged to review our filings
with Canadian securities regulatory authorities, including our 2007
Annual Information Form filed on SEDAR at http://www.sedar.com.
All forward-looking statements and information made herein are based
on our current expectations as of the date hereof and we disclaim
any intention or obligation to revise or update such forward-looking
statements and information to reflect subsequent events or circumstances,
except as required by law.
Contact:
Donna Slade
Director, Investor Relations
9381 Judicial Drive, Suite 180
San Diego, CA USA 92121
Dir: 858.202.4945
dslade@nventacorp.com
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CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS
(Unaudited)
(Canadian dollars) (In thousands, except per share amounts)
|
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Three months
ended, |
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Six months
ended |
|
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June 30, |
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June 30,
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2008 |
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2007 |
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2008 |
|
2007 |
Revenue: |
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Collaborative
research and development
revenue |
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- |
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$ 155 |
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- |
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$ 310 |
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|
|
|
|
|
|
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Operating expenses: |
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Research and development |
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2,955 |
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1,719 |
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4,381 |
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3,538 |
Selling, general and administrative |
|
911 |
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1,090 |
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1,869 |
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2,430 |
Corporate restructuring |
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- |
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794 |
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- |
|
794 |
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3,866 |
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3,603 |
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6,250 |
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6,762 |
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Operating loss |
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(3,866) |
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(3,448) |
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(6,250) |
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(6,452) |
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Other income (expense): |
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Interest and other income, net |
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61 |
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144 |
|
172 |
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271 |
Net foreign exchange (loss) gain |
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(125) |
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(634) |
|
283 |
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(828) |
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(64) |
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(490) |
|
455 |
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(557) |
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|
|
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Net loss and comprehensive
loss |
|
$ (3,930) |
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$ (3,938) |
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$ (5,795) |
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$ (7,009) |
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|
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Basic and diluted
loss per common share |
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$ (0.02) |
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$ (0.02) |
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$ (0.02) |
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$ (0.04) |
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|
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Weighted average
number of shares used to
compute basic and diluted loss per
per common share (in thousands) |
|
261,152 |
|
191,887 |
|
260,938 |
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183,430 |
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CONDENSED CONSOLIDATED BALANCE SHEET INFORMATION
(Unaudited)
(Canadian dollars in thousands)
| |
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June 30,
2008 |
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December 31,
2007 |
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| Cash, cash equivalents and short-term investments |
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$ 8,069 |
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$ 12,859 |
| Total assets |
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9,089 |
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14,471 |
| Stockholders’ equity |
|
7,366 |
|
12,781 |
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| Total shares outstanding (in thousands) |
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261,211 |
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260,586 |
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