Nventa Biopharmaceuticals Corporation (NVN) Provides Corporate Update and Advancement Plans for HspE7, Hsp 6/11 and Poly-ICR; Company Announces Corporate Restructuring to Focus on Strategic Alliances and M&A, Reduces Staff by 60%
SAN DIEGO, October 8 /PRNewswire/ -- Nventa Biopharmaceuticals Corporation (TSX: NVN - News), a company developing innovative therapeutics for the treatment of viral infections and cancer, today provided an update on its ongoing development programs. The company also announced that it will initiate a corporate restructuring that will extend the company's financial resources to pursue near-term corporate development opportunities, sale of specific programs, M&A and alternative financial arrangements to maximize the value of its assets.
"We are committed to the continued advancement of HspE7, Hsp 6/11 and Poly-ICR, and as such, we are making difficult yet necessary decisions today to ensure these products have every opportunity to succeed," said Gregory M. McKee, president and chief executive officer at Nventa. "As part of our commitment to the continued advancement of HspE7, Hsp 6/11 and Poly-ICR, we are aggressively seeking strategic alliances, including merger and acquisition opportunities, which will allow us to realize the greatest value for each of these important programs."
HspE7: Lead Product Candidate for the Treatment of Cervical Intraepithelial Neoplasia (CIN)
A recently completed Phase 1 clinical trial of HspE7, a novel therapeutic candidate intended for the treatment of precancerous and cancerous lesions caused by the human papillomavirus (HPV), demonstrated an excellent safety profile, while providing compelling data to support HspE7's immunologic activity. Based on the positive Phase 1 trial results, the next planned initiatives include Phase 2 clinical studies that will evaluate HspE7 as a potential treatment for both low-grade cervical dysplasia (CIN 1) and high-grade cervical dysplasia (CIN 2/3). The planned Phase 2 trials consist of multi-center, randomized, double-blind, placebo-controlled studies in the U.S., Canada, Europe and Latin America. For the CIN 2/3 study, protocol development, discussions with the U.S. Food and Drug Administration and site evaluations have been completed. A second protocol for the CIN 1 indication is near completion. Partnering or adequate financing are required for the trials to be initiated.
Poly-ICR -- Proprietary Toll-like Receptor 3 Agonist
The company's proprietary Toll-like Receptor 3 agonist, Poly-IC: Poly-Arginine (Poly-ICR), may have use as a broad immune stimulatory agent, as well as a vaccine adjuvant for both therapeutic and prophylactic vaccines. Nventa is currently advancing Poly-ICR as a means for revenue generation through partnering, as well as for its own internal development.
-- Partnering Poly-ICR -- Nventa is currently providing Poly-ICR through 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. Based on early interest in Poly-ICR, the company anticipates that it may provide Nventa with a near-term revenue opportunity.
-- Internal Application of Poly-ICR -- Nventa is pursuing the development of Poly-ICR for topical application for the treatment of genital warts (GW) and actinic keratosis, a premalignant condition of the skin. Next development activities include completing toxicology and formulation activities for Poly-ICR and filing an investigational new drug (IND) application for the compound. Partnering or adequate financing are required for this work to be continued.
Hsp 6/11 -- Preclinical Product Candidate for the Treatment of GW and RRP
The company has nominated Hsp 6/11 as a development candidate targeting the treatment of 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 US$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 target antigens. Next steps for Hsp 6/11 include finalizing manufacturing and formulation protocols and filing an IND. Partnering or adequate financing are required for these efforts to continue.
Corporate Restructuring and Focus on Corporate Development Efforts
With the support of a unanimous decision by Nventa's board of directors, the company will undertake a corporate restructuring designed to extend the company's financial resources and increase the focus on corporate development efforts surrounding the company's core assets. Key elements of the restructuring include:
-- A sixty percent reduction of staff from 13 to 5. As part of this reduction, Richard B. Lai Fatt, Ph.D., vice president of corporate development and David Duncan, Jr., vice president of finance, will be leaving the company. Peter Emtage, Ph.D. will remain as vice president of research and development. Concurrent with the restructuring, board members, Jay M. Short, Ph.D., Joann Data, M.D., Ph.D., Gordon Busenbark, and Sandford D. Smith, as well as all members of the scientific advisory board, will be stepping down. Robert Rieder will become chairman of the board and John Varian will continue as the audit committee chair. -- A reduction of annualized cash burn of approximately 30 percent. -- An increased focus of corporate resources toward monetizing the company's core assets. As part of this, the company will expand its corporate development efforts for the purpose of identifying synergistic merger and acquisition opportunities to strengthen its pipeline and/or financial position. -- Cash and cash equivalents as of October 1, 2008 were approximately US$5.9 million, which after accounting for the company's liabilities and other commitments, results in approximately US$2.5 million. This cash is sufficient to support operations until second quarter 2009.
About Nventa Corporation:
Nventa is developing innovative therapeutics for the treatment of viral infections and cancer, with a focus on diseases caused by HPV. The company 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 statements regarding the company's future plans, objectives, performance, growth or the company's underlying assumptions. The words "may", "would", "will", "expect," "intend", "plan", "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: our planned corporate restructuring and the affect it will have on our financial resources; plans to seek strategic alliances and our subsequent ability to realize the greatest value for our programs; our planned Phase 2 clinical studies and the ability of those studies to successfully evaluate HspE7 as a potential treatment for CIN 1 and CIN 2/3; the structure and location of our planned Phase 2 trials; completion of the second protocol for CIN 1; potential uses for Poly-ICR; our ability to advance Poly-ICR resulting in revenue generation and internal development; the ability of Poly-ICR to provide us with near-term revenue opportunity; the development of Poly-ICR for treatment of GW and actinic keratosis; completion of development activities and the filing of an IND application in connection with Poly-ICR; finalizing manufacturing and formulation protocols and filing an IND in connection with Hsp 6/11; execution of our corporate restructuring as planned; our ability to retain key personnel; and our plan to expand corporate development efforts and the potential results of such efforts.
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 our planned corporate restructuring will not have the anticipated affect; that we will not succeed in forming strategic alliances and, if we do, the possibility that such alliances will not allow us to realize the greatest value for our programs; that we will not commence Phase 2 clinical studies as planned and, if we do, that such studies will not support the use of HspE7 as a treatment for CIN 1 or CIN 2/3; that we will not complete the second protocol for the CIN 1 indication; that Poly-IRC will not be useful as a broad immune stimulatory agent or vaccine adjuvant; that we will not be able to advance Poly-ICR to generate revenue or for internal development; that Poly-ICR will not provide us with near-term revenue opportunity; that Poly-ICR will not be useful in the treatment of GW or actinic keratosis; that we will not complete development activities or file an IND application in connection with Poly-ICR; that we will not finalize manufacturing or formulation protocols or file an IND in connection with Hsp 6/11; that we will be unable to execute our corporate restructuring as planned; that we will be unable to expand corporate development efforts as planned and that such efforts will not produce the desired results; that results from future clinical trials will not be consistent with our expectations; that we will not be able to recruit patients for our planned trials in a timely manner; our need for capital, which may not be available on a timely basis, or at all; 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 obtaining clinical supply materials; 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 our planned corporate restructuring will have the anticipated affect; that we will succeed in forming strategic alliances and that such alliances will allow us to realize the greatest value for our programs; that we will commence Phase 2 clinical studies as planned and that such studies will support the use of HspE7 as a treatment for CIN 1 and CIN 2/3; that we will complete the second protocol for the CIN 1 indication; that Poly-IRC will be useful as a broad immune stimulatory agent and vaccine adjuvant; that we will be able to advance Poly-ICR to generate revenue and for internal development; that Poly-ICR will provide us with near-term revenue opportunity; that Poly-ICR will be useful in the treatment of GW and actinic keratosis; that we will complete development activities and file an IND application in connection with Poly-ICR; that we will finalize manufacturing and formulation protocols and file an IND in connection with Hsp 6/11; that we will be able to execute our corporate restructuring as planned; that we will be able to expand corporate development efforts as planned and that such efforts will produce the desired results; that results from future clinical trials will be consistent with our expectations; that we will raise enough capital (through partnering or otherwise), 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, Hsp 6/11 and Poly-ICR in a timely manner; that sufficient HspE7, Hsp 6/11 and Poly-ICR will be available to conduct our planned clinical trials; that we will obtain timely approval from additional Investigational Review Boards; that the results from additional preclinical and clinical work, if any, will be consistent with the results we have already obtained; and that a sufficient number of patients will be available to conduct our planned trials, and that sufficient data will be generated in such trials.
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.