SAN DIEGO, CA, May 11 /PRNewswire-FirstCall/ - Nventa Biopharmaceuticals Corporation announced today financial results for the three months ended March 31, 2007. All amounts, unless specified otherwise, are in Canadian dollars. The Company also provided an update on its lead candidate, HspE7, an investigational therapeutic vaccine for the treatment of serious human papillomavirus (HPV)-related diseases.
Nventa reported a net loss of $3.1 million or $0.02 (US$0.02) per share, for the three months ended March 31, 2007, compared to a net loss of $2.7 million, or $0.03 (US$0.03) per share, for the same period in 2006. The Company had cash, cash equivalents and short-term investments of $14.3 million as of March 31, 2007.
NVENTA HIGHLIGHTS - Granted U.S. patent covering HspE7’s use in treating patients with anogenital warts; - Won challenge to U.S. patents for core fusion technology, concluding ex-parte reexamination process and allowing two patents to be maintained in amended form; - Announced additional HspE7 clinical trial data in cervical dysplasia patients presented by Mark H. Einstein M.D. of the Albert Einstein School of Medicine; data demonstrated that 78 percent of patients in this NCI-sponsored trial showed complete response or reduction of lesion size by more than 50 percent; - Granted U.S. patent covering heat shock protein fusion to treat influenza; - Raised $16.2 million in additional capital.
“Along with the top-line activities highlighted above, our development team has been focused on initiating our Phase 1 bridging trial of new HspE7 in patients with cervical intraepithelial neoplasia (CIN), which we are on track to begin mid-2007,” stated Gregory M. McKee, President and Chief Executive Officer of Nventa. “With the positive feedback we received from the U.S. Food and Drug Administration (FDA) regarding clinical studies of new HspE7, and completion of a C$16.2 million capital raise during the first quarter, we are poised to re-enter the clinic shortly.”
Following a November 21, 2006 meeting with the FDA, Nventa announced that it had received positive feedback regarding the use of new HspE7 which incorporates the adjuvant Poly-ICLC in future clinical studies. This new approach has shown significantly increased activity in well characterized HPV animal models. 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.
In April 2007, Nventa submitted final sections of an amendment to its Investigational New Drug (IND) filing with the FDA. This amendment includes updated Chemistry, Manufacturing and Controls (CMC) information, covering details of Nventa’s new manufacturing process for HspE7 and cross-reference letters to third party INDs to facilitate review of the pertinent information for the Poly-ICLC adjuvant. In addition, the Company has completed and submitted to the FDA the protocol design for a Phase 1 bridging study in patients with cervical dysplasia (CIN), along with toxicology data outlining the safety of the new HspE7. CIN is the abnormal growth of precancerous cells on the cervix that can lead to cervical cancer. The Phase 1 protocol has been submitted to the University of Southern California’s (USC) Clinical Institutional Committee (CIC) for review, prior to submission to USC’s Investigational Review Board (IRB), as well as to other IRBs. Linda Roman, M.D. of USC will be the principal investigator in that study with additional sites participating in Utah and New York. The Phase 1 bridging study is designed primarily to assess the safety and tolerability of new HspE7, but will also collect immunological data from these patients that may provide an early indication of potential efficacy of the compound. The study is expected to enroll twenty four (24) patients.
About Nventa Biopharmaceuticals Corporation:
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Nventa is developing innovative therapeutics for the treatment of viral infections and cancer, with a focus on diseases caused by the human papillomavirus (HPV). 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 financials are attached below. The full financial statements and MD&A for the three months ended March 31, 2007 can be found on SEDAR at http://www.sedar.com.
This press release contains statements which, to the extent that they are not recitations of historical fact may constitute forward-looking information under applicable Canadian securities legislation or forward-looking statements within the meaning of the Unites 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”, “estimate”, “plan”, “forecast”, “project” and “believe” or other similar words and phrases are intended to 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: entering clinical development of our reformulated lead compound, HspE7 and developing a treatment for targeting serious HPV-related diseases; the details surrounding the Phase 1 bridging study including, but not limited to, the identity of the principal investigator, the location of sites participating in the study, the type and usefulness of data that will be collected in the study, the number of patients that will be enrolled in the study, and if and when the study will begin; and developing innovative therapeutics for the treatment of viral infections and cancer, with a focus on diseases caused by HPV.
Such forward-looking statements or information involve known and unknown risks, uncertainties and other factors that may cause our actual results, events or developments, or industry results, to be materially different from any future results, events or developments expressed or implied by such forward-looking statements or information. Such factors include, among others, 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 and ultimately marketed; the possibility that such government agency approvals will not be obtained in a timely manner or at all; risks associated with the requirement that a drug be found safe and effective after extensive clinical trials and the possibility that the results of such trials, if commenced and completed, will not establish the safety or efficacy of our products; our dependence on suppliers of adjuvant and other materials, 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; our ability to protect and practice our intellectual property; the risk that competitors may develop and market drugs that are less expensive, more effective or safer than ours; and other factors as described in detail in our filings with the Canadian securities regulatory authorities at www.sedar.com. Given these risks and uncertainties, you are cautioned not to place undue reliance on such forward-looking statements and information, which are qualified in their entirety by this cautionary statement.
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 in a timely manner; that enough HspE7 will be available to conduct planned trials; that we will be able to procure the necessary amount of adjuvant to conduct planned trials; that if conducted, the results of our Phase I trial will be favorable; that we will obtain timely approval from IRB; that the results from additional pre-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 a successful clinical trial; that sufficient data will be generated to support an IND.
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, or at all.
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 2006 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, including Stressgen’s 2005 Annual Information Form dated March 16, 2006 may be reviewed on SEDAR at http://www.sedar.com under the SEDAR profile GVIC Publications Ltd.
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. CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS (Unaudited) (Canadian dollars) (In thousands, except per share amounts) For the three months ended March 31, ---------------------------- 2007 2006 ------------- ------------- Revenue: Collaborative R&D revenue $ 155 $ 155 Operating expenses: Research and development 1,819 2,207 Selling, general and administrative 1,340 684 ------------- ------------- 3,159 2,891 ------------- ------------- Operating loss (3,004) (2,736) Other income (expense): Interest and other income, net 127 19 Net foreign exchange (loss) (194) (28) ------------- ------------- (67) (9) ------------- ------------- Net loss $ (3,071) $ (2,745) ------------- ------------- ------------- ------------- Basic and diluted loss per common share $ (0.02) $ (0.03) ------------- ------------- Weighted average common shares outstanding (in thousands) 174,879 83,070 ------------- ------------- ------------- ------------- CONDENSED CONSOLIDATED BALANCE SHEET INFORMATION (Unaudited) (Canadian dollars in thousands) March 31, December 31, 2007 2006 ------------- ------------- Cash, cash equivalents and short-term investments $ 14,263 $ 2,972 Total assets 15,372 4,619 Stockholders’ equity 13,825 2,303 Total shares outstanding (in thousands) 191,628 83,669
CONTACT: Gregory McKee, President and Chief Executive Officer, 9381 Judicial Drive, Suite 180, San Diego, CA USA 92121, Dir: (858) 202-4940, gmckee@nventacorp.com; Donna Slade, Director, Investor Relations, 9381 Judicial Drive, Suite 180, San Diego, CA USA 92121, Dir: (858) 202-4945, dslade@nventacorp.com
Nventa Biopharmaceuticals Corporation
CONTACT: Gregory McKee, President and Chief Executive Officer, 9381Judicial Drive, Suite 180, San Diego, CA USA 92121, Dir: (858) 202-4940,gmckee@nventacorp.com; Donna Slade, Director, Investor Relations, 9381Judicial Drive, Suite 180, San Diego, CA USA 92121, Dir: (858) 202-4945,dslade@nventacorp.com
