SAN DIEGO, Nov. 11 /PRNewswire-FirstCall/ -- Nventa Biopharmaceuticals
Corporation (TSX: NVN) today announced financial results for the third
quarter and nine months ended September 30, 2008, and highlighted several
recent product developments and corporate milestones.
Recent product and corporate highlights:
o On October 8, 2008, the company announced that it will initiate a
corporate restructuring that will extend the company's financial
resources to pursue near-term corporate development opportunities,
including completion of a merger and acquisition (M&A) transaction,
the sale of specific programs, and/or completion of other
alternative financial arrangements.
o The company announced positive clinical results from its Phase 1
trial of HspE7, a therapeutic treatment for patients with cervical
intraepithelial neoplasia, or CIN, a precursor to cervical cancer.
During the third quarter, 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.
o During the quarter, the company won a challenge to its European
patent covering the company's lead product candidate, HspE7, and
other human papillomavirus (HPV) therapeutics.
o Nventa presented positive data from preclinical studies using its
proprietary Toll-like Receptor 3 agonist, Poly IC-Poly Arginine
(Poly-ICR), at the World Vaccine Congress 2008 in Lyon, France.
Study results demonstrated Poly-ICR to be a potent vaccine adjuvant
targeting the Toll-like Receptor 3 (TLR3) pathway. Data showed that
Poly-ICR, in combination with model antigens, elicits strong anti-
target antibody and CD8 T-cell immune responses. These findings
demonstrate the versatility of Poly-ICR, suggesting that the
compound may possess broad potential for use in both therapeutic and
o The company recently announced that it has nominated Hsp 6/11 as a
development candidate targeting the treatment of genital warts (GW)
and recurrent respiratory papillomatosis (RRP), a disease in which
benign tumors grow on the larynx, vocal cords and trachea.
Combined, GW and RRP affect more than 2.5 million people worldwide
and represent an estimated global market potential of more than $1
billion. There are currently no approved cures for either
condition. Early preclinical data suggest that Hsp 6/11 has the
ability to elicit strong T-cell responses against HPV types 6 and 11
"During the quarter, Nventa announced positive clinical results for our
lead candidate, HspE7, presented important and compelling findings on the
potency of our proprietary adjuvant, and expanded our pipeline by
nominating Hsp 6/11 for further development," said Gregory M. McKee,
president and chief executive officer at Nventa. "We are also very
enthusiastic about our Material Transfer Agreements to leading vaccine
developers in the U.S. and abroad who are evaluating Poly-ICR for potential
incorporation into a wide range of vaccine products. Nventa remains
committed to the value in our core assets and we are working aggressively
with multiple parties to explore opportunities to best create shareholder
Third Quarter and Nine Months ended September 30, 2008 Financial Results
All amounts referenced below are in Canadian dollars.
Nventa reported a net loss of $1,864,000, or $0.01 per share, for the third quarter of 2008, compared to a net loss of $3,085,000, or $0.01 per share, for the third quarter of 2007. The $1,221,000 decrease in net loss in the third quarter of 2008, compared to the third quarter of 2007, principally was due to a $930,000 improvement in foreign exchange and to a $468,000 reduction in SG&A expenses. These favorable net loss items were partially offset by a $155,000 reduction in collaborative R&D revenue and reduced interest and other income of $125,000 during the third quarter of 2008.
Nventa reported a net loss of $7,659,000, or $0.03 per share, for the nine months ended September 30, 2008, compared to a net loss of $10,094,000, or $0.05 per share, for the same period of 2007. The reduced loss of $2,435,000 in the first nine months of 2008, compared to the first nine months of 2007, principally was due to a $2,041,000 improvement in foreign exchange, an $814,000 reduction in corporate restructuring expenses, and a $1,029,000 reduction in SG&A expenses. The lower expenses for corporate restructuring and SG&A were principally the result of cost savings associated with the closure of the Victoria facility in June 2007. These cost reductions, however, were partially offset by an increase in R&D expenses of $760,000, due to significantly higher spending in 2008 for clinical trials and adjuvant development costs and to lower collaborative R&D revenue of $465,000 because the amortization of upfront license fees from the Roche agreement ended in December 2007, and to lower interest and other income of $224,000, because of lower average cash balances in 2008, as compared to 2007.
The company had cash and cash equivalents of $6,166,000 as of September 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(TM) 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 http://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 nine months ended September 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.
(financial information attached)
CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS
(Canadian dollars) (In thousands, except per share amounts)
Three months ended Nine months ended
September 30, September 30,
2008 2007 2008 2007
and development revenue $- $155 $- $465
Research and development 1,426 1,509 5,807 5,047
Selling, general and
administrative 709 1,177 2,578 3,607
Corporate restructuring - 20 - 814
2,135 2,706 8,385 9,468
Operating loss (2,135) (2,551) (8,385) (9,003)
Other income (expenses):
Interest and other income,
net 34 159 206 430
Net foreign exchange gain
(loss) 237 (693) 520 (1,521)
271 (534) 726 (1,091)
Net loss and comprehensive loss $(1,864) $(3,085) $(7,659) $(10,094)
Basic and diluted loss per
common share $(0.01) $(0.01) $(0.03) $(0.05)
Weighted average number of
shares used to compute basic
and diluted loss per common
share (in thousands) 261,211 221,139 261,908 196,138
CONDENSED CONSOLIDATED BALANCE SHEET INFORMATION
(Unaudited)(Canadian dollars in thousands)
September 30, December 31,
Cash and cash equivalents $6,166 $12,859
Total assets 6,750 14,471
Stockholders' equity 5,623 12,781
Total shares outstanding (in thousands) 261,211 260,586
|SOURCE Nventa Biopharmaceuticals Corporation|
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