TORONTO--()--SQI Diagnostics Inc. (TSX-V: SQD), a life sciences company that develops and commercializes proprietary technologies and products for advanced microarray diagnostics, today announced its financial and operational results for the fourth quarter and year ended September 30, 2012.
“We believe that the expected initiation of commercial projects and the regulatory submission of additional Ig_PLEX products in fiscal 2013 will create additional commercial opportunities and success in the coming year.”
Highlights for the fiscal year ended September 30, 2012
- The Company’s sales efforts focussed on generating multiple opportunities in the Diagnostic Tools and Services segment. The prospects were grouped into the following general categories: Immunology Diagnostic Manufacturers, Contract Research Organizations and Blood Bank Testing Manufacturers. These targets were progressed to varying degrees including what the Company believes are proposals to significant opportunities, some of which resulted in site visits to SQI to assess the Company’s platforms and capabilities to develop products on an OEM basis. A letter of intent was executed during fiscal 2012 with a leading CRO governing a collaboration for the development of a proof of concept immunogenicity assay (“Ig_PLEX”) to detect, measure and quantify multiple isotypes and sub-class antibodies to a therapeutic protein in a single assay.
- Our IVD sales efforts focussed on increasing product adoption at our existing customer. The Company also entered into a Letter of Intent with Integrated Sciences for the distribution of our IVD products in Australia and we expect this relationship to create additional sales opportunities that we expect will be leveraged by the completion of our next quantitative Celiac product for which we expect to file for regulatory clearances in the US, Canada and Europe.
- The Company completed the development of IgX PLEX Celiac DGP Quantitative assay and progressed this assay into the verification stage.
- A white paper was published and is available on the Company’s website detailing the performance of our 8-plex cytokine inflammation panel. The Company’s 8-plex RUO antibody panel for the quantification of cytokines progressed to final development. Monitoring cytokine expression represents a major segment of the RUO immunoassay market and this panel’s development is targeted as a demonstration panel for the Company’s Diagnostic Tools and Services segment.
- The Company commenced work on a proof of concept assay which extended our antibody isotype detection to include the Ig subclass to meet the needs of customers who are required to demonstrate the biosafety of protein therapeutics. Subsequent to the year end the Company was invited to present at the European Bioanalysis Forum Open Symposium to provide pharmaceutical companies and CROs with the technical basis of our ability to multiplex and automate immunogenicity and other multi-biomarker tests and the economic benefits of using our technologies.
- Subsequent to the year end the Company launched its SQiDlite system at American Association of Pharmaceutical Scientists Annual Meeting and Exposition targeting pharmaceutical companies and CROs with bioanalytical testing needs in the various phases of drug development and clinical trials. Management believes that these and other direct sales efforts to have been very successful and expects that they will result in either paid proof of concept projects and/or initiating turn-key RUO agreements for our Diagnostics Tools and Services products and services.
- Completed two separate private placements for total gross proceeds of approximately $10.7 million.
“With the traction developing on our Diagnostics Tools and Services Business we believe significant progress is being made on our business model.” said Andrew Morris, CFO of SQI Diagnostics. “We believe that the expected initiation of commercial projects and the regulatory submission of additional Ig_PLEX products in fiscal 2013 will create additional commercial opportunities and success in the coming year.”
The Company has converted to International Financial Reporting Standards for fiscal 2012.
For the year ended September 30, 2012, the Company recorded a net loss of $6,311,000 ($0.17 net loss per share) compared to a net loss of $10,744,000 ($0.32 net loss per share) for the year ended September 30, 2011.
For the quarter-ended September 30, 2012, the Company recorded a net loss of $1,727,000 ($0.04 net loss per share) compared to a net loss of $3,896,000 ($0.11 net loss per share) for the quarter-ended September 30, 2011.
R&D expenditures, excluding amortization and stock based compensation, for the year ended September 30, 2012 were $3,057,000 compared to $5,456,000 for the year ended September 30, 2011. R&D expenditures, excluding amortization and stock based compensation, for the quarter-ended September 30, 2012 were $820,000 compared to $1,400,000 for the quarter-ended September 30, 2011. With fewer projects in active development the Company reduced expenditures on salaries, lab consumables, scientific consultants, partnering and validation costs. In addition, the Canada Revenue Agency concluded an audit of the Company’s SR&ED claims for the 2008, 2009 and 2010 fiscal years which resulted in a $504,000 investment tax credit being recorded in the fiscal 2012 year as compared to $300,000 in the fiscal 2011 year. The Company is continuing to progress the celiac quantitative assay, the vasculitis quantitative assay through the verification and/or final development stage.
Corporate and general expenses, excluding stock-based compensation, totaled $1,801,000 for the year ended September 30, 2012 compared to $3,636,000 for the year ended September 30, 2011. Corporate and general expenses, excluding stock-based compensation, totaled $501,000 for the three months ended September 30, 2012 compared to $2,111,000 for the year ended September 30, 2011. The decrease in corporate and general expenses is primarily related to a reduction in profession fees, travel and other securities filing costs related to proposed acquisition and related US IPO. Both were abandoned in the first quarter of 2012.
At September 30, 2012, current assets were $4,208,000 compared to $1,266,000 at September 30, 2011. Working capital as at September 30, 2012 was $3,190,000 compared to ($1,322,000) at September 30, 2011.
Detailed financial statements and the MD&A are available at www.sedar.com.
About SQI Diagnostics
SQI Diagnostics is a life sciences company that develops and commercializes proprietary technologies and products for advanced microarray diagnostics. The Company’s proprietary microarray tests and fully-automated systems are designed to simplify protein and antibody testing workflow, increase throughput, reduce costs and provide excellent data quality. For more information, please visit www.sqidiagnostics.com.
This press release contains certain forward-looking statements, including, without limitation, statements containing the words “may”, “plan”, “will”, “estimate”, “continue”, “anticipate”, “intend”, “expect”, “believe”, “in the process”, “is subject to” and other similar expressions which constitute “forward-looking information” within the meaning of applicable securities laws. Forward-looking statements reflect the Company's current expectation and assumptions, and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated. These forward-looking statements involve risks and uncertainties including, but not limited to, our need for additional capital to sustain our business, statements with respect to sales of our IgX plex™ Celiac product and SQiDworks, SQiDlite and other analytical systems, agreements and future agreements to sell our products, the success of our Diagnostic Tools and Services business and our intent to build near-term revenue streams from this business, the build-out of our portfolio of quantitative tests, the successful regulatory filing and receipt of regulatory approvals for our later stage quantitative diagnostic kits, the acceleration of our revenue ramp, general economic and market segment conditions, competitor activity, technology changes and regulatory approvals. Such statements reflect the current views of the Company with respect to future events and are subject to certain risks and uncertainties and other risks detailed from time-to-time in the Company’s ongoing filings with the securities regulatory authorities, which filings can be found at www.sedar.com. Actual results, events, and performance may differ materially. Readers are cautioned not to place undue reliance on these forward-looking statements. The Company undertakes no obligation to publicly update or revise any forward-looking statements either as a result of new information, future events or otherwise, except as required by applicable securities laws.
This news release does not constitute an offer to sell or a solicitation of an offer to sell any of the securities in the United States. The securities have not been and will not be registered under the United States Securities Act of 1933, as amended (the "U.S. Securities Act") or any state securities laws and may not be offered or sold within the United States or to U.S. persons unless registered under the U.S. Securities Act and applicable state securities laws or an exemption from such registration is available.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.