Friday, 11 May 2012

Inovio says it has "expanding dialog" to secure non-dilutive funding

Inovio Pharmaceuticals (AMEX:INO) said Thursday that it has an "expanding dialog" with vaccine and biotech companies, as well as non-governmental and government agencies, with respect to securing non-dilutive financing for its vaccine programs.

The talks could also potentially lead to new collaborations and partnerships to advance the development and commercialization of its SynCon vaccines, the company said.

The company’s SynCon vaccines are designed to provide broad cross-strain protection against known and newly emergent unmatched strains of pathogens such as influenza.

These synthetic vaccines, in combination with Inovio's proprietary electroporation delivery, have been shown to generate positive immune responses, along with a favourable safety profile.

Aside from the flu, Inovio also has clinical programs for cervical dysplasia, leukemia, the hepatitis C virus, and HIV.

At the beginning of the year, Inovio said that was moving closer to a "universal flu vaccine" as animal studies showed protective antibody immune responses against multiple H3N2 and Type B strains.

The new data built on previous studies by the company, which reported that its H5N1 synthetic vaccine achieved hemagglutination inhibition (HI) titers against six unmatched strains of this influenza subtype in a phase I human study.

The H3N2, H1N1, and Type B influenza strains represented in each year’s seasonal influenza vaccine are updated annually, but only protect against a single strain within each of these subtypes.

When a selected strain mutates, the annual vaccine may not provide protection, as witnessed with the 2009 swine flu H1N1 pandemic, Inovio said.

Consequently, there is a case for a universal vaccine that is able to provide longer-term protection against all existing and potential new strains, within the flu subtypes of concern to humans.

For the quarter that ended March 31, the company reported a wider net loss of $8.3 million, or 6 cents per share, due primarily to a significant non-cash change in fair value of common stock warrants.

This is based on a required quarterly mark to market adjustment to reflect changes in the company's stock price, and decrease in grant revenue.

Total revenue was $1.7 million for the latest period, versus $3.1 million a year earlier - a result of timing of work performed under the company's contract with the National Institute of Allergy and Infectious Diseases (NIAID).

This contract revenue amounted to $1.5 million versus $2.7 million a year earlier. The NIAID contract, which exceeds $23 million over five years (plus two additional option years), is facilitating Inovio's development of a universal, preventive HIV DNA vaccine, Pennvax-GP.

Total operating expenses were $5.9 million compared to $7.5 million in the first quarter of 2011.

As of quarter-end, the company had cash and equivalents plus short-term investments of $25.0 million. Inovio said it believes it has sufficient cash to meet is planned working capital requirements into the third quarter of 2013.

Aside from the flu vaccine progress, the company also reported in the first quarter significant vaccine-specific T-cell responses from its HIV-001 phase I study. The trial, which tested HIV-positive volunteers, was designed to assess safety and levels of immune responses generated by Inovio's Pennvax-B vaccine delivered with its electroporation device.

The company said the results affirmed "best-in-class immune responses" reported last year from Inovio's HVTN-080 phase I study of Pennvax-B in healthy volunteers.

Enrollment is also ongoing in Inovio's phase II clinical study of VGX-3100 for cervical dysplasia. Data is expected in the second half of 2013.

Interim data from phase II studies for leukemia and the hep C virus are due in the second half of this year, while data from two phase I influenza studies are slated for the second quarter.

In other progress, Inovio received a patent covering its synthetic consensus influenza H1 antigen, which relates to the company's H1N1 influenza constructs and INO-3510 universal influenza vaccine.

The company was also awarded a U.S. Department of Defense research grant to advance a low-cost, non-invasive surface electroporation delivery device and test its utility in combination with Inovio's synthetic vaccines against viruses with bioterrorism potential.

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