Medicago Announces 2013 First Quarter Financial Results

QUEBEC CITY, May 9, 2013 /CNW/ -   Medicago Inc. (TSX: MDG), a biopharmaceutical company focused on developing highly effective and competitive vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), today announced its operational and financial results for the first quarter ended March 31, 2013. The Company's financial statements and management report are available at www.sedar.com and at www.medicago.com.

"In the first quarter of 2013, we announced several strategic agreements for our plant-based vaccines. This included the execution of a $15 million non-dilutive loan with a major pharmaceutical company," said Andy Sheldon, President and Chief Executive Officer. "Discussions are ongoing with this  pharmaceutical company to finalize a licensing agreement. We also signed an agreement with Mitsubishi Chemical Corporation, and were awarded a delivery contract with DARPA enabling us to leverage our commercial production facility in North Carolina."

Mr. Sheldon continued, "Following the recent announcement of our best in class H5N1 clinical data with IDRI, we expect to commence a pandemic readiness Phase II clinical trial, as well as a U.S. phase II clinical trial for our quadrivalent seasonal flu vaccine."

Corporate and Financial Highlights
During the first quarter of 2013:

• Awarded an Indefinite Delivery / Indefinite Quantity (ID/IQ) contract from DARPA based on Medicago having met all the technical requirement standards for the contract and is now allowed to bid for the manufacture and delivery of certain tobacco-produced proteins.
• Executed a $15,000,000 loan agreement with a major Pharmaceutical company.  Medicago is continuing discussions to finalize a licensing agreement with this pharma partner.
• Investissement Quebec has agreed to a three-year extension of the maturity date of Medicago Inc.'s 2003 loan made under the BioLevier program. Originally, the maturity date of the loan in the principal amount of $15.3-million, was Dec. 31, 2014, and is now Dec. 31, 2017. Under this new agreement, Medicago will be required to make minimum annual repayments of $1.75-million, $2.5-million and $2.5-million in 2014, 2105 and 2016, respectively, with the remaining balance due on Dec. 31, 2017.
• Execution of a collaboration agreement with Mitsubishi Chemical Holdings Corporation ("MCHC") to develop a next generation technology for plant production.

Subsequent to the first quarter:

• Announced positive phace I clinical results for its H5N1 vaccine in a trial run by IDRI. The vaccine was found to be safe and well-tolerated and induced a solid immune response exceeding the three CHMP (Committee for Medicinal Products for Human Use) immunogenicity criteria for licensure of influenza vaccines. The vaccine was tested in three different configurations: using IDRI's Glucopyranosyl Lipid A ("GLA") formulated adjuvant, given both intramuscularly and intradermally, and using alum intramuscularly. All three configurations exceeded the CHMP criteria.
• Raised $3.5 million through a private placement of 6.25 million common shares.

Corporate Outlook

Expected upcoming milestones include:

• Phase II pandemic readiness clinical trial for H5N1 pandemic influenza vaccine with interim data expected in summer 2013
• US Phase IIa clinical trial for quadrivalent seasonal influenza vaccine with interim data expected in summer 2013
• Additional contract opportunities (government, pharmaceutical companies)
• Addition of new pipeline candidates

Financial Results

The consolidated loss for the three-month period ended March 31, 2013, was $8,716,070 or $0.04 per basic and diluted share.  This compares to a loss of $8,987,326 or $0.04 per basic and diluted share for the three-month period ended March 31, 2012.  Operating expenses were $9,135,328 in the three-month period ended March 31, 2013, compared to $9,143,941 in 2012. on of more than 10,000,000 doses of vaccines for the DARPA project.  Since June 2011, the Corporation has completed a Phase II clinical trial for its H5N1 VLP vaccine, a Phase I clinical trial for its H1N1/seasonal vaccine, a Phase I clinical trial for its H5N1 with a new adjuvant, added a rabies vaccine to its portfolio, completed the construction of its US facility, commissioned the US facility and completed the production of more than 10,000,000 doses of vaccines for the DARPA project.  All of those activities have resulted in increased expenses during the last six quarters.

Cash and short-term investments were $15.3 million as at March 31, 2013, an increase of $4.0 million from December 31, 2012.

As at May 9, 2013, there were 254,657,245 common shares issued and outstanding as well as 12,468,684 stock options outstanding.  Warrants outstanding as at May 9, 2013 are in the aggregate of 15,649,160.

Voting Results of Annual Meeting of Shareholders

At the Annual Meeting of Shareholders held today, all matters submitted to the vote of the shareholders were approved, namely the election of directors and the appointment of auditors.

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. The detailed results of the vote for the election of directors are set out below. For further information, please refer to the management proxy circular available on www.sedar.com.

Election of Directors            

Video - Medicago's Commercial Scale Vaccine Facility
This year, Medicago is pleased to present its 2013 corporate video of its commercial scale vaccine facility. The video will allow viewers to see Medicago's state of the art vaccine facility and will also provide  an understanding  of the operational processes of Medicago's proprietary plant-based manufacturing platform. The video will be available on the company's website on Friday, May 10th. To view the video please go to: www.medicago.com/investors (3 minutes).

About Medicago
Medicago is a clinical-stage biopharmaceutical company developing novel vaccines and therapeutic proteins to address a broad range of infectious diseases worldwide. The Company is committed to providing highly effective and competitive vaccines and therapeutic proteins based on its proprietary VLP and manufacturing technologies. Medicago is a worldwide leader in the development of VLP vaccines using a transient expression system which produces recombinant vaccine antigens in plants. This technology has potential to offer more potent vaccines with speed and cost advantages over competitive technologies, enabling the development of a vaccine for testing in approximately one 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, and supply large volumes of vaccine antigens to the world market. Medicago also intends to expand development into other areas such as biosimilars and biodefense products where the benefits of our technologies can make a significant difference. 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 "Risk Factors and Uncertainties" in Medicago's Annual Information Form filed on March 28, 2013, 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.