- Field trial concordance data exceed targeted criteria
- Planned issuance of $36 million in Senior Secured Notes
JERSEY, Channel Islands, June 18, 2018 (GLOBE NEWSWIRE) — Quotient Limited (NASDAQ:QTNT), a commercial-stage diagnostics company, today reported concordance data for the initial MosaiQ blood grouping microarray generated in its European field trial, which exceed the targeted criteria for submission for CE marking. Under the terms of the indenture governing its 12% Senior Secured Notes due 2023, Quotient now plans to issue an additional $36 million of notes with funding to occur within 10 business days of the date of this press release.
“It gives me great pleasure to report positive field trial results for our initial blood grouping microarray,” said Franz Walt, Chief Executive Officer of Quotient. Mr. Walt added, “The achievement of this milestone will provide access to additional debt capital to fund the next important steps of our development, which include a CE mark submission, initial commercialization and the ongoing expansion of the MosaiQ test menu to include the second antigen typing microarray, our initial serological disease tests for CMV and Syphilis and ultimately the full serological and molecular disease screening microarrays.”
In connection with the issuance of the additional notes, the purchasers will also be allocated an additional 0.6% royalty right with respect to aggregate net sales of MosaiQ Instruments and MosaiQ Microarrays made in the donor testing market in the United States and the European Union.
MosaiQ IH Microarray Field Trial Performance – Antigen Typing and Antibody Detection
A summary of European field trial results compared with the predicate technology is set out below:
The above results imply overall concordance of 99.6% for the MosaiQ antigen typing microarray. Also in the European field trial, the antibody detection microarray was demonstrated to be 97.3% concordant with the predicate technology. Greater than 3,000 donations were tested in the concordance portion of the field trial.
Regulatory and Commercial Milestones are Confirmed
- European Regulatory Approval – Quotient expects to file for European regulatory approvals for our initial MosaiQ IH microarray in the second half of calendar 2018 and for the initial Serological Disease Screening (SDS) microarray in the first half of calendar 2019
- European Commercialization – Quotient has already received invitations to participate in tenders once MosaiQ has obtained European approval for the initial IH microarray
- IH Microarray Ongoing Development – Quotient plans for the expansion of the IH antigen testing menu during the second half of calendar 2018
- U.S. Field Trials – Quotient expects to commence U.S. field trials with the expanded antigen testing menu in the first half of calendar 2019
- U.S. Regulatory Approval – Quotient expects to file for U.S. and European regulatory approval for the expanded IH microarray in the second half of calendar 2019
MosaiQ, Quotient’s next-generation platform is designed to deliver fast, comprehensive antigen typing, antibody detection and disease screening results, using a single low volume sample in a high throughput automated format. MosaiQ represents a transformative and highly disruptive unified testing platform for transfusion diagnostics. Feasibility has also been demonstrated with respect to the detection of nucleic acids (DNA or RNA) using the MosaiQ platform. Through MosaiQ, Quotient expects to deliver substantial value to donor testing laboratories worldwide by providing affordable, routine comprehensive characterization and screening of blood products, on a single automated instrument platform designed to radically reduce labor costs and the complexity associated with existing practice.
About Quotient Limited
Quotient is a commercial-stage diagnostics company committed to reducing healthcare costs and improving patient care through the provision of innovative tests within established markets. With an initial focus on blood grouping and serological disease screening, Quotient is developing its proprietary MosaiQTM technology platform to offer a breadth of tests that is unmatched by existing commercially available transfusion diagnostic instrument platforms. The Company’s operations are based in Edinburgh, Scotland; Eysins, Switzerland and Newtown, Pennsylvania.
This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements regarding our expectations relating to the development, regulatory approval, commercialization and impact of MosaiQ and other new products, and the timing of the issuance of the additional notes and royalty rights. Such statements are based on current assumptions that involve risks and uncertainties that could cause actual outcomes and results to differ materially. These risks and uncertainties, many of which are beyond our control, include delays or denials of regulatory approvals or clearances for products or applications; market acceptance of our products; the impact of competition; the impact of facility expansions and expanded product development, clinical, sales and marketing activities on operating expenses; delays or other unforeseen problems with respect to manufacturing, product development or field trial studies; adverse results in connection with any ongoing or future legal proceeding; continued or worsening adverse conditions in the general domestic and global economic markets; as well as the other risks set forth in the Company’s filings with the Securities and Exchange Commission. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Quotient disclaims any obligation to update these forward-looking statements.
The Quotient logo and MosaiQ™ are registered trademarks or trademarks of Quotient Limited and its subsidiaries in various jurisdictions.
CONTACT: Chris Lindop, Chief Financial Officer – firstname.lastname@example.org; +41 22 545 52 26