- Company Advancing Lead Candidate HspE7 into Phase 2 Clinical Trial in
SAN DIEGO, March 13 /PRNewswire-FirstCall/ -- Nventa Biopharmaceuticals
Corporation announced today financial results for the year ended December
31, 2007, and highlighted the corporate milestones achieved during the
During 2007, the Company achieved the following corporate milestones:
Progress on Lead Candidate HspE7:
-- Made significant progress on the Company's Phase 1 cervical dysplasia
clinical trial examining the safety of new HspE7 leading to the recent
completion of enrollment and initial dosing of the last cohort in this
-- Presented preclinical data at International Papillomavirus conference
demonstrating that co-administering HspE7 with certain adjuvants
promotes more potent responses than HspE7 alone
-- Demonstrated ability to elicit long-lasting tumor protection in vivo
suggesting that HspE7 may have utility in HPV-related diseases
-- Announced data from NCI-sponsored trial in cervical dysplasia showing
78 percent of patients achieved complete response or reduction of
lesion size by more than 50 percent
Corporate and Financial Achievements:
-- Strengthened the Management team with the addition of Richard Lai Fatt,
Ph.D., as Vice President of Corporate Development, and David Duncan,
Jr., as Vice President of Finance
-- Appointed Sandford D. Smith, President of the International Group and
Executive Vice President of Genzyme Corporation, to the Board of
-- Assembled a distinguished group of international experts for the
Company's Clinical and Scientific Advisory Board
-- Raised $24.8 million in two successful public offerings
Strengthened Intellectual Property Portfolio:
-- Granted a U.S. patent for HPV fusions to treat patients with HPV-
-- Granted a U.S. patent covering heat shock protein fusions to treat
-- Won an important challenge to two U.S. patents; U.S. Patent and
Trademark Office reissued composition of matter and methods of use for
Company's CoVal(TM) fusions
-- Granted European patent covering CoVal(TM) fusion proteins to treat
Gregory M. McKee, President and Chief Executive Officer at Nventa
commented on the year: "2007 was a year of significant events at Nventa. We
are very pleased with the progress we made during the past year as we
advanced new HspE7 (HspE7 + Poly-ICLC) into a Phase 1 clinical trial and
completed the safety evaluation for three of the four cohorts in the trial.
We anticipate completing the evaluation of the remaining cohort by the end
of the second quarter of 2008, and are working diligently to design the
Phase 2 clinical program, expected to begin shortly after this Phase 1
trial, to test new HspE7 in a larger population of patients with cervical
dysplasia." Mr. McKee continued, "With the strength of our Directors, the
addition of two new senior managers and the creation of a distinguished
board of international experts, we look forward to building additional
value for our shareholders through the continued advancement of new HspE7
for human papillomavirus (HPV)-related diseases."
Total Year 2007 and Fourth Quarter Financial Results:
All amounts, unless specified otherwise, are in Canadian dollars.
Nventa reported a net loss of $12,413,000, or $0.06 per share, for the year ended December 31, 2007, compared to a net loss of $10,067,000, or $0.12 per share, for the same period in 2006. The increase in net loss in 2007 from 2006 is principally related to a $1,726,000 increase in foreign exchange losses, due to the strength of the Canadian dollar against the U.S. dollar, and to $844,000 of restructuring expenses incurred in 2007. These two factors were partially offset in 2007 by an increase in interest income of $433,000 relating to the completion of the Company's two equity offerings, which generated gross proceeds of $24,807,000.
Nventa also reported a net loss of $2,319,000, or $0.01 per share, for the three months ended December 31, 2007, compared to a net loss of $2,043,000, or $0.02 per share, for the fourth quarter of 2006. The $276,000 increase in the net loss in the fourth quarter of 2007, compared to 2006, is principally related to a $200,000 increase in foreign exchange losses and to restructuring expenses incurred during 2007. These expense increases were partially offset by an increase in interest income of $124,000 during the fourth quarter of 2007, as a result of receiving the proceeds from the Company's two public equity offerings in 2007.
The Company had cash and cash equivalents of $12,859,000 as of December 31, 2007, compared to $2,972,000, as of December 31, 2006.
About New HspE7
The Company's lead candidate, new HspE7 (HspE7 + Poly-ICLC), is a novel therapeutic candidate intended for the treatment of precancerous and cancerous lesions caused by the human papillomavirus (HPV), one of the most common sexually transmitted diseases in the world. New HspE7 contains the novel CoVal(TM) fusion protein, HspE7 co-administered with the adjuvant Poly-ICLC, a toll-like receptor-3 (TLR3) agonist. An adjuvant is a substance added to vaccines to improve immune responses against target antigens. HspE7 is derived from Nventa's proprietary CoVal(TM) fusion platform, which uses recombinant DNA technology to covalently fuse stress proteins to target antigens, thereby stimulating cellular immune responses to the target antigens. Nventa is developing new HspE7 for multiple indications.
About Nventa Corporation:
Nventa is developing innovative therapeutics for the treatment of viral infections and cancer, with a focus on diseases caused by the human papillomavirus, or HPV. The corporation is publicly traded on the Toronto Stock Exchange under the symbol NVN. For more information about Nventa, please visit http://www.nventacorp.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 clinical development and other projections as well as statements regarding the Company's future plans, objectives, performance, operating expenses, 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 predictions, 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: evaluation of the remaining cohort by the end of the second quarter; the beginning of our Phase 2 clinical program; and continued advancement of HspE7 for HPV-related diseases.
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 availability of clinical trial materials; the possibility that we will not be able to recruit patients for our planned trials in a timely manner; our need for capital, 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 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 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 + Poly-ICLC in a timely manner; that enough HspE7 and Poly-ICLC will be available to conduct our planned trials; that we will obtain timely approval from additional IRBs; that the results from additional preclinical and clinical work, if any, will be consistent with the results we have already obtained; that a sufficient number of patients will be available to conduct our planned trials; and that sufficient data will be generated to support our BLA. 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. Historical filings
relating to the Company prior to the completion of the Company's March 23,
2006 corporate reorganization may be reviewed on SEDAR at
http://www.sedar.com under the SEDAR profile GVIC Communications Corp.
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.
Nventa Biopharmaceuticals Corp
Condensed Consolidated Statement of Operations
(Canadian dollars)(In thousands, except per share amounts)
Three Months Ended Twelve Months Ended
December 31, December 31,
2007 2006 2007 2006
and development revenue $156 $156 $621 $621
Research and development 1,549 1,587 6,596 7,351
Selling, general and
administrative 922 714 4,529 3,565
Corporate restructuring 30 - 844 -
2,501 2,301 11,969 10,916
Operating loss (2,345) (2,145) (11,348) (10,295)
Other income (expenses):
Interest and other
income, net 141 17 571 138
Net foreign exchange
(loss) gain (115) 85 (1,636) 90
26 102 (1,065) 228
Net loss and
comprehensive loss $(2,319) $(2,043) $(12,413) $(10,067)
Basic and diluted
loss per common share: $(0.01) $(0.02) $(0.06) $(0.12)
Weighted average number of
shares used to compute
basic and diluted loss
per common share
(in thousands) 260,836 83,669 212,449 83,440
Condensed Consolidated Balance Sheet Information
(Canadian dollars)(In thousands, except per share amounts)
December 31, December 31,
Cash and cash equivalents $12,859 $2,972
Total assets 14,471 4,619
Stockholders' equity 12,781 2,303
Total shares outstanding (in thousands) 260,586 83,669
|SOURCE Nventa Biopharmaceuticals Corporation|
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