QUEBEC CITY, QUEBEC, May 27, 2011 /PRNewswire/ - Medicago Inc. (TSX: MDG), a biotechnology company focused on developing highly effective and affordable vaccines based on proprietary manufacturing technologies and Virus-Like Particles, today announced its operational and financial results for the first quarter ended March 31, 2011. The Company's financial statements and management report are available at www.sedar.com and at www.medicago.com.
"We recently achieved positive phase II interim results for our pandemic H5N1 Influenza VLP vaccine candidate. We continue to advance our clinical pipeline and look forward to reporting final phase II data for our H5N1 vaccine candidate and our U.S. phase I clinical data for our seasonal vaccine candidate this quarter," said Andy Sheldon, President and CEO of Medicago. "In parallel, we are pursuing our strategy of partnership with countries and pharmaceutical companies looking at investing in faster and economical technologies for the production of pandemic and seasonal flu vaccines and other non-influenza vaccines."
Highlights:
Corporate
- Selected to collaborate with the Infectious Disease Research Institute (IDRI) on a multimillion-dollar grant awarded to IDRI by the U.S. Department of Defense's Defense Advanced Research Projects Agency (DARPA) for the proposed development of a single-dose H5N1 influenza vaccine which could be rapidly and widely administered in the case of an avian pandemic flu outbreak.
- Reported positive phase II interim results for its clinical trial with its H5N1 avian influenza vaccine. The vaccine was found to be safe, well tolerated and also induced a solid immune response.
- Received FDA clearance to initiate phase I clinical trial for its phase I H1N1 influenza VLP vaccine candidate clinical trial in the United States. The Company initiated this trial on March 21, 2011. This phase I trial is expected to lead into Medicago's U.S. phase IIa trial for its seasonal trivalent vaccine with the recommended H1N1, H3N2 and B influenza strains.
Financial
- Received the second milestone payment of $3.8-million (U.S.) from DARPA. This is part of the $21-million (U.S.) DARPA grant awarded to Medicago to demonstrate the scalable manufacturing of its plant-expressed virus-like particle vaccines in the United States under a technology investment agreement. Medicago has received $10.7-million (U.S.) to date for this project.
- Subsequent to quarter end, Medicago closed an offering of 34,117,600 units (each, a "Unit") at a price of $0.51 per Unit, representing gross proceeds of $17,399,976 (the "Offering"). Philip Morris Investments BV, an insider of the Company, participated in the offering and acquired 17,058,800 units.
Outlook
In the first quarter of 2011, the Company reported positive interim phase II results for its clinical trial with its H5N1 avian influenza vaccine. The Company is proceeding with the second part of the phase II trial with final results expected before the end of the second quarter. Upcoming milestones include among others:
- Phase II final results with its H5N1 vaccine
- Initiation of U.S. phase I clinical trial with its H1N1 vaccine. Results are expected in Q2 2011.
- Operational U.S. vaccine facility
- Initiation of U.S. phase II clinical trial with trivalent seasonal vaccine if authorization granted by FDA
- Potential contracts with governments and pharmaceutical companies
- Addition of new pipeline candidates (vaccines, biosimlar enzymes)
Financial Results
The Company's unaudited interim consolidated financial statements as at and for the three months ended March 31, 2011, represent the Company's first filing in accordance with international financial reporting standards ('IFRS'). Comparative unaudited consolidated financial statements for 2010 have been adjusted to reflect the Company's adoption of IFRS on a retrospective basis, effective on Jan. 1, 2010.
Consolidated loss for the three-month period ended March 31, 2011 was $5,051,000 or $0.04 per basic and diluted share, compared to a loss of $3,742,000 or $0.03 per basic and diluted share in the same period in 2010. Increase in the loss for the three month period is mainly explained by the increase in R&D expenses in relation with the H5N1 Phase II clinical trial and the H1N1/seasonal vaccine Phase I clinical trial that is underway.
Cash and short-term investments were $6.9 million as at March 31, 2011. Subsequent to quarter end, Medicago closed an offering of 34,117,600 units at a price of $0.51 per Unit, representing gross proceeds of $17,399,976.
As at May 26, 2011, there were 173,039,702 common shares issued and outstanding as well as 8,710,263 stock options outstanding. Warrants outstanding and Unit options outstanding as at May 26, 2011 represented a total of 28,288,113 shares.
Voting Results of Annual Meeting of Shareholders
At the Annual Meeting of Shareholders held yesterday all matters put before the shareholders were approved, namely approval of our new by-laws and the modification of the stock option plan. The Board of Directors will consist of Randal Chase, Andrew J. Sheldon, Pierre Seccareccia, Jonathan Goodman, Pierre-Marc Johnson, Pierre Des Marais II and Louis P. Vézina. For further details, please see the management proxy circular available on www.sedar.com.
About Medicago
Medicago is committed to provide highly effective and affordable vaccines based on proprietary Virus-Like Particle (VLP) and manufacturing technologies. Medicago is developing VLP vaccines to protect against H5N1 pandemic influenza, using a transient expression system which produces recombinant vaccine antigens in non-transgenic plants. This technology has potential to offer advantages of speed and cost over competitive technologies. It could deliver a vaccine for testing in about a month after the identification and reception of genetic sequences from a pandemic strain. This production time frame has the potential to allow vaccination of the population before the first wave of a pandemic strikes and to supply large volumes of vaccine antigens to the world market. Additional information about Medicago is available at www.medicago.com.
Forward Looking Statements
This news release includes certain forward-looking statements that are based upon current expectations, which involve risks and uncertainties associated with Medicago's business and the environment in which the business operates. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking, including those identified by the expressions "anticipate", "believe", "plan", "estimate", "expect", "intend", and similar expressions to the extent they relate to Medicago or its management. The forward-looking statements are not historical facts, but reflect Medicago's current expectations regarding future results or events. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results or events to differ materially from current expectations, including the matters discussed under "Risks Factors and Uncertainties" in Medicago's Annual Information Form filed on March 31, 2011 with the regulatory authorities. Medicago assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those reflected in the forward-looking statements.
SOURCE Medicago Inc.
