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Helicos BioSciences (HLCS) Issues Q2 Operating Highlights and Strategic Update

September 3, 2009 9:46 AM EDT
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Helicos BioSciences Corporation (NASDAQ: HLCS) announced today its operating highlights for the quarter ended June 30, 2009 and other recent developments following the filing of its Quarterly Report on Form 10-Q for the period ended June 30, 2009.

"In the second quarter of 2009, we continued to deploy our Helicos(TM) Genetic Analysis System and to advance our technology. The number of installation sites doubled during the second quarter following the installation of our systems in some of the world's most distinguished research sites. We also proudly congratulate the Stanford team for using their HeliScope(TM) Sequencer to publish the first ever single-molecule view of a whole human genome. I am pleased to see Helicos gaining commercial momentum in the marketplace and our technology producing scientific results that distinguish single molecule sequencing," said Ronald A. Lowy, Helicos Chief Executive Officer.

Helicos's unique True Single Molecule Sequencing (tSMS)(TM) technology allows scientists and clinical researchers to accurately sequence and quantitate DNA, including minute amounts of ancient and degraded DNA, without amplification or ligation, eliminating the biases inherent in those techniques, and providing increases in throughput and reductions in cost that enable breakthrough scientific research.

Operational Highlights:

Commercial

To date, Helicos has installed six Helicos(TM) Genetic Analysis Systems at the following sites:
  • The Broad Institute of MIT and Harvard (Broad)
  • Stanford University Stem Cell Institute (Stanford)
  • Dana Farber Cancer Institute (Dana Farber)
  • Mass General Hospital Cancer Center (MGH)
  • Ontario Institute for Cancer Research (OICR)
  • An undisclosed biotechnology company in the Northeast
Of these installations, Stanford and the undisclosed biotechnology company represent outright system purchases. As previously disclosed, Broad received its system at no cost in early 2009. Dana Farber, MGH and OICR represent placement installations which have been designated as reference sites for scientific and commercial evaluation. These reference sites will have the opportunity to purchase their system outright at the end of the evaluation period.

In addition, Helicos received a system order from St. Laurent Institute. The site location for this system installation and contractual terms associated with the order are being revised by the parties.

Helicos expects that all of these systems will provide additional revenue from the sale of proprietary reagents and that the results of the system evaluations at the reference sites will lead to additional instrument sales.

The current performance capability and applications of the Helicos(TM) Genetic Analysis Platform have generated significant interest from potential customers worldwide. Helicos's quoting activity continues to be enhanced by the new funding opportunities from the National Institutes of Health and the National Science Foundation, released as part of the American Recovery and Reinvestment Act (ARRA). Helicos actively supported customers in the preparation of ARRA grant proposals for research projects that could benefit from the unique features of the Helicos platform.

Recently, Helicos reached an important milestone with a customer's publication of "Single Molecule Sequencing of an Individual Human Genome" in Nature Biotechnology. Helicos scientists, as well as collaborators, continue to submit and publish manuscripts in top-tier, peer-reviewed scientific journals in areas of resequencing, gene expression, genome regulation, single-molecule proteomics and technology innovation, demonstrating the value of Helicos's tSMS approach.

Technology and Science
  • As previously disclosed, Helicos achieved technical feasibility of its paired-read technology in the first quarter of 2009. We are expanding our initial paired-read methods to enable >1kb spacers with the same simple sample preparation used for generating single reads; a capability that is unique in the marketplace. Helicos expects its paired-read technology to be available to customers during the fourth quarter of 2009.
  • Helicos scientists published two manuscripts, "Quantification of the yeast transcriptome by single-molecule sequencing" in Nature Biotechnology and "Virtual terminator nucleotides for next-generation DNA sequencing" in Nature Methods as well as a manuscript published in collaboration with Dr. Robi Mitra at Washington University in St. Louis entitled "Protein quantification in complex mixtures by solid phase single-molecule counting" in Analytical Chemistry. Links to these publications can be found on the Helicos Web site at http://www.helicosbio.com/HeliSphereCenter/PublicationsLibrary/HelicosScientificPublications/tabid/169/Default.aspx.
  • The first ever single molecule view of a human genome was completed in one month's time by three scientists headed by Dr. Steve Quake at Stanford University using a Helicos(TM) Genetic Analysis System. This work has been published in Nature Biotechnology and is available on-line at http://www.nature.com/nbt/journal/vaop/ncurrent/abs/nbt.1561.html.
  • Helicos successfully completed collaborations to analyze ancient human DNA samples, which had been difficult or impossible to analyze using other sequencing technologies.
  • In collaboration with a major cancer center in the US, Helicos enabled sequencing of DNA from archival clinical tumor samples (formalin-fixed paraffin embedded or FFPE tissue samples), potentially unlocking the capability to carry out retrospective genetic analysis studies for cancer research.
  • The use of small amounts of starting material for all applications has emerged as a distinguishing benefit of the Helicos(TM) Genetic Analysis System; this has allowed the accurate, high-throughput study of genome regulation using applications such as Chromatin Immunoprecipitation (ChIP-Seq) and Digital Gene Expression (DGE) on a limited number of cells.
Strategic Update:

As previously disclosed in the Company's Quarterly Report on Form 10-Q for the period ended June 30, 2009, the Company is actively engaged in discussions with potential strategic partners regarding various strategic alternatives including equity financings and other sources of funding, such as joint ventures or partnerships. Such discussions have involved parties inside and outside of the genetic sequencing space. In connection with this activity, the Company has engaged Thomas Weisel Partners (TWP), a nationally recognized investment bank, to assist the Company with its evaluation and execution of strategic alternatives.

The Company is pursuing various strategies in parallel and may ultimately engage in one or more alternative financings or none at all. The Company's failure to raise capital as and when needed would have a material negative impact on its financial condition and would have a material adverse impact on the viability of the Company as a going concern.

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