SAN DIEGO, Oct. 8 Nventa BiopharmaceuticalsCorporation (TSX: NVN), a company developing innovative therapeutics for thetreatment of viral infections and cancer, today provided an update on itsongoing development programs. The company also announced that it will initiatea corporate restructuring that will extend the company's financial resourcesto pursue near-term corporate development opportunities, sale of specificprograms, M&A and alternative financial arrangements to maximize the value ofits assets.
"We are committed to the continued advancement of HspE7, Hsp 6/11 andPoly-ICR, and as such, we are making difficult yet necessary decisions todayto ensure these products have every opportunity to succeed," said Gregory M.McKee, president and chief executive officer at Nventa. "As part of ourcommitment to the continued advancement of HspE7, Hsp 6/11 and Poly-ICR, weare aggressively seeking strategic alliances, including merger and acquisitionopportunities, which will allow us to realize the greatest value for each ofthese important programs."
HspE7: Lead Product Candidate for the Treatment of CervicalIntraepithelial Neoplasia (CIN)
A recently completed Phase 1 clinical trial of HspE7, a novel therapeuticcandidate intended for the treatment of precancerous and cancerous lesionscaused by the human papillomavirus (HPV), demonstrated an excellent safetyprofile, while providing compelling data to support HspE7's immunologicactivity. Based on the positive Phase 1 trial results, the next plannedinitiatives include Phase 2 clinical studies that will evaluate HspE7 as apotential treatment for both low-grade cervical dysplasia (CIN 1) andhigh-grade cervical dysplasia (CIN 2/3). The planned Phase 2 trials consistof multi-center, randomized, double-blind, placebo-controlled studies in theU.S., Canada, Europe and Latin America. For the CIN 2/3 study, protocoldevelopment, discussions with the U.S. Food and Drug Administration and siteevaluations have been completed. A second protocol for the CIN 1 indicationis near completion. Partnering or adequate financing are required for thetrials 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, aswell as a vaccine adjuvant for both therapeutic and prophylactic vaccines.Nventa is currently advancing Poly-ICR as a means for revenue generationthrough partnering, as well as for its own internal development.
-- Partnering Poly-ICR -- Nventa is currently providing Poly-ICR throughMaterial Transfer Agreements to leading vaccine developers in the U.S. andabroad who are evaluating Poly-ICR for potential incorporation into a widerange of vaccine products. Based on early interest in Poly-ICR, the companyanticipates that it may provide Nventa with a near-term revenue opportunity.
-- Internal Application of Poly-ICR -- Nventa is pursuing the developmentof Poly-ICR for topical application for the treatment of genital warts (GW)and actinic keratosis, a premalignant condition of the skin. Next developmentactivities include completing toxicology and formulation activities forPoly-ICR and filing an investigational new drug (IND) application for thecompound. Partnering or adequate financing are required for this work to becontinued.
Hsp 6/11 -- Preclinical Product Candidate for the Treatment of GW and RRP
The company has nominated Hsp 6/11 as a development candidate targetingthe treatment of GW and recurrent respiratory papillomatosis (RRP), a diseasein 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 anestimated global market potential of more than $1 billion. There arecurrently no approved cures for either condition. Early preclinical datasuggest that Hsp 6/11 has the ability to elicit strong T-cell responsesagainst HPV types 6 and 11 target antigens. Next steps for Hsp 6/11 includefinalizing 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 thecompany's financial resources and increase the focus on corporate developmentefforts surrounding the company's core assets. Key elements of therestructuring include:
About Nventa Corporation:
Nventa is developing innovative therapeutics for the treatment of viralinfections and cancer, with a focus on diseases caused by HPV. The company ispublicly traded on the Toronto Stock Exchange under the symbol "NVN". Formore information about Nventa, please visit http://www.nventacorp.com.
This press release contains statements which may constituteforward-looking information under applicable Canadian securities legislationor forward-looking statements within the meaning of the United States PrivateSecurities Litigation Reform Act of 1995. Such forward-looking statements orinformation may include statements regarding the company's future plans,objectives, performance, growth or the company's underlying assumptions. Thewords "may", "would", "will", "expect," "intend", "plan", "estimate" and"believe" or other similar words and phrases may identify forward-lookingstatements or information. Persons reading this press release are cautionedthat such statements or information are only expectations, and that thecompany'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 plannedcorporate restructuring and the affect it will have on our financialresources; plans to seek strategic alliances and our subsequent ability torealize the greatest value for our programs; our planned Phase 2 clinicalstudies and the ability of those studies to successfully evaluate HspE7 as apotential treatment for CIN 1 and CIN 2/3; the structure and location of ourplanned Phase 2 trials; completion of the second protocol for CIN 1; potentialuses for Poly-ICR; our ability to advance Poly-ICR resulting in revenuegeneration and internal development; the ability of Poly-ICR to provide uswith near-term revenue opportunity; the development of Poly-ICR for treatmentof GW and actinic keratosis; completion of development activities and thefiling of an IND application in connection with Poly-ICR; finalizingmanufacturing and formulation protocols and filing an IND in connection withHsp 6/11; execution of our corporate restructuring as planned; our ability toretain key personnel; and our plan to expand corporate development efforts andthe potential results of such efforts.
Such forward-looking statements or information involve known and unknownrisks, uncertainties and other factors that may cause our actual results,events or developments to be materially different from results, events ordevelopments expressed or implied by such forward-looking statements orinformation. Such factors include, among others, the possibility that ourplanned corporate restructuring will not have the anticipated affect; that wewill not succeed in forming strategic alliances and, if we do, the possibilitythat such alliances will not allow us to realize the greatest value for ourprograms; 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 treatmentfor CIN 1 or CIN 2/3; that we will not complete the second protocol for theCIN 1 indication; that Poly-IRC will not be useful as a broad immunestimulatory agent or vaccine adjuvant; that we will not be able to advancePoly-ICR to generate revenue or for internal development; that Poly-ICR willnot provide us with near-term revenue opportunity; that Poly-ICR will not beuseful in the treatment of GW or actinic keratosis; that we will not completedevelopment activities or file an IND application in connection with Poly-ICR;that we will not finalize manufacturing or formulation protocols or file anIND in connection with Hsp 6/11; that we will be unable to execute ourcorporate restructuring as planned; that we will be unable to expand corporatedevelopment efforts as planned and that such efforts will not produce thedesired results; that results from future clinical trials will not beconsistent with our expectations; that we will not be able to recruit patientsfor our planned trials in a timely manner; our need for capital, which may notbe available on a timely basis, or at all; risks associated with requirementsfor approvals by government agencies such as the FDA before products can betested in clinical trials; the possibility that such government agencyapprovals will not be obtained in a timely manner or at all or will beconditioned in a manner that would impair our ability to advance development;risks associated with the requirement that a drug candidate be found safe andeffective after extensive clinical trials; our dependence on suppliers,collaborative partners and other third parties and the prospects and timingfor obtaining clinical supply materials; our ability to attract and retain keypersonnel; and other factors as described in detail in our filings with theCanadian securities regulatory authorities at http://www.sedar.com.
Assumptions underlying our expectations regarding forward-lookingstatements or information contained in this press release include, amongothers that our planned corporate restructuring will have the anticipatedaffect; that we will succeed in forming strategic alliances and that suchalliances will allow us to realize the greatest value for our programs; thatwe will commence Phase 2 clinical studies as planned and that such studieswill support the use of HspE7 as a treatment for CIN 1 and CIN 2/3; that wewill complete the second protocol for the CIN 1 indication; that Poly-IRC willbe useful as a broad immune stimulatory agent and vaccine adjuvant; that wewill be able to advance Poly-ICR to generate revenue and for internaldevelopment; 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 inconnection with Poly-ICR; that we will finalize manufacturing and formulationprotocols and file an IND in connection with Hsp 6/11; that we will be able toexecute our corporate restructuring as planned; that we will be able to expandcorporate development efforts as planned and that such efforts will producethe desired results; that results from future clinical trials will beconsistent with our expectations; that we will raise enough capital (throughpartnering or otherwise), on reasonable terms and in a timely manner; that wewill retain our key personnel; that we will obtain the necessary regulatoryapprovals related to HspE7, Hsp 6/11 and Poly-ICR in a timely manner; thatsufficient HspE7, Hsp 6/11 and Poly-ICR will be available to conduct ourplanned clinical trials; that we will obtain timely approval from additionalInvestigational Review Boards; that the results from additional preclinicaland clinical work, if any, will be consistent with the results we have alreadyobtained; and that a sufficient number of patients will be available toconduct our planned trials, and that sufficient data will be generated in suchtrials.
In the event that any of these assumptions prove to be incorrect, or inthe event that we are impacted by any of the risks identified above, we maynot be able to continue in our business as planned.
For a complete discussion of the assumptions, risks and uncertaintiesrelated to our business, you are encouraged to review our filings withCanadian securities regulatory authorities, including our 2007 AnnualInformation Form filed on SEDAR at http://www.sedar.com.
All forward-looking statements and information made herein are based onour current expectations as of the date hereof and we disclaim any intentionor obligation to revise or update such forward-looking statements andinformation to reflect subsequent events or circumstances, except as requiredby law.-- 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 $5.9 million, which after accounting for the company's liabilities and other commitments, results in approximately $2.5 million. This cash is sufficient to support operations until second quarter 2009.
SOURCE Nventa Corporation