Amarantus Diagnostics and Avant Diagnostics to acquire Theranostics Health

March 7, 2016 – SCOTTSDALE. Avant Diagnostics, a biotechnology company focused on the development of oncology based diagnostics, and Amarantus Diagnostics, a wholly-owned subsidiary of Amarantus BioScience Holdings, Inc., today announced that the companies have jointly entered into a letter of intent for Avant to acquire Theranostics Health Incorporated (“THI”), adding key CLIA laboratory and intellectual property capabilities to Avant and Amarantus’ previously announced diagnostics merger. Theranostics currently generates over $1.5M in services revenue from some of the world’s leading biopharmaceutical companies, including 7 of the top 10 pharmaceutical companies by revenue.

Under the terms of the agreement, Avant shall issue to Theranostics 25 million shares of its common stock upon the closing. Amarantus has provided a convertible note bridge financing of $400,000 to Theranostics to facilitate the transaction that will be assumed by Avant upon closing of the transactions. The 3-way business combination is expected to close on or before March 31st, 2016, and is subject to customary closing conditions.

“Theranostics Health is a leader in the area of signal transduction biology, where they have been able to attract an A-list of pharmaceutical customers collaborating with the company to evaluate the therapeutic benefit and potential of their drug candidates using THI’s proprietary assays,” said Gerald E. Commissiong, President & CEO of Amarantus. “In addition, THI has a CLIA lab where Amarantus’ diagnostics division has established operations over the course of the first quarter that will allow for CLIA validation and commercial launch of the combined company’s suite of high-value, proprietary diagnostics in the areas of oncology and neurology. THI’s sales channel into the pharmaceutical industry will provide important leverage for the combined company to market the LymPro Test® for Alzheimer’s disease. We could not have picked a better partner to bring Avant and Amarantus’ leading-edge intellectual property in diagnostics and biomarkers to the market.”

“Key to the business case for the merged company is THI’s impressive pharma services revenue base and sales channel in the area of cell signaling biology,” said Gregg Linn, President & CEO of Avant Diagnostics. “In addition to this, THI’s CLIA laboratory provides the combined company with the infrastructure to launch OvaDx®, MSPrecise® and LymPro Test in a regulatory compliant environment that has been vetted by some of the world’s top pharmaceutical companies. THI’s laboratory meets the highest quality standards under CLIA/CAP which should give both our pharmaceutical and commercial customers great confidence in the information generated in THI’s laboratory.”

Theranostics Health’s core business is centered on providing pharmaceutical and biotechnical companies access to its technology for quantitatively measuring the activation status of key proteins and signal transduction pathways that are dysregulated in multiple disease processes via its Reverse-phase Protein Array (RPPA) platform. The Company is experienced in running CAP-accredited assays in its CLIA laboratory for predicting response to therapies in difficult to treat cancers.  The Company believes that, while genomic approaches may identify potential activating mutations in diseased tissues, measuring the actual activation status of the protein drug targets and the signal transduction pathways that they regulate, provides physicians with much-needed evidence that a particular therapeutic strategy can provide benefits to the patient.  The Company has launched tests, TheraLink® Assays, for guiding therapeutic decisions in breast and colorectal cancer. The post-merger Avant Diagnostics will further build on its recognized scientific expertise in the area of cell cycle biology to increase its pharma services revenues and provide therapy guiding diagnostics in difficult to treat conditions.

“After an extensive evaluation of the diagnostics market, we believe that we have found the best potential partners in Avant and Amarantus,” commented Glenn Hoke, PhD, Chief Executive Officer of Theranostics Health. “It is clear that we will be expanding our CLIA offerings with much needed tests such as OvaDx in cancer and MSPrecise in neurology, while also providing significant additional pharma services business development opportunities with the LymPro Test. With platforms in microarray proteomics, ELISA, flow cytometry and ‘next-gen’ sequencing, the combined company’s capabilities will allow it to add cross-platform diagnostics as we grow into the future.”

Post-merger Avant CLIA Pipeline 

1. OvaDx® immuno-oncology diagnostic assay is a protein-based test, potentially representing a significant improvement in the screening and diagnosis for ovarian cancer. OvaDx offers the possibility to make a clear improvement to the current diagnostic standard that generates over $2B in sales annually by substantially improving the accuracy of diagnosis, and allowing for a more effective therapeutic triaging and intervention strategy. Longer term, the assay could become a much-needed early screening tool for all women as part of a standard screening paradigm. It is estimated that the market opportunity for OvaDx is $50M annually as a diagnostic test for ovarian cancer, and that this opportunity would expand to over $2B annually if it were to be approved as a generalized screening and/or monitoring tool.

2. MSPrecise® neuroimmunology-based next-gen sequencing diagnostic assay for multiple sclerosis (MS) offers a potentially highly accurate and actionable result that will substantially improve upon the high mis-diagnosis rate of this degenerative disease. More specifically, MS has an approximately 40% misdiagnosis rate, meaning that improving diagnostic accuracy will be a key driver to adopt more effective therapeutic strategies that will reduce costs for payers and improve outcomes for patients.  The potential market opportunity for MSPrecise as a diagnostic for multiple sclerosis is over $200M annually, and could increase to over $1B if it were to be approved as a monitoring tool to measure the efficacy of drug treatment.

3. LymPro Test® neuroimmunology-based flow cytometry assay for Alzheimer’s Disease (AD), offers an early, accurate, and scalable diagnostic result for physicians seeking to provide the best information and treatment plan for patients from the earliest stages of this devastating disease. AD diagnosis has an approximately 30% misdiagnosis rate. AD costs the healthcare system approximately $200 B in direct costs per year, and these costs are expected to exceed $1.2T by 2050 according to the current spending and demographics trajectories. The estimated market opportunity for LymPro is over $3B in a commercial setting as a generalized screening test for patients at their initial Medicare enrollment visit.

Post-merger Avant Pharma Services Pipeline 

1. TheraLink® Assay includes phospho-activation markers for known drug targets of over 30 approved molecular targeted therapies for treating breast cancer patients. In addition, the TheraLink® Assay panel includes other biomarkers that have utility in directing patients to clinical trials involving new investigational agents. Research programs and clinical trials are underway at leading institutions to validate the TheraLink® Assay panel for managing cancer treatment decision-making in other clinically significant areas such as colorectal, lung, pancreatic and ovarian cancer.

2. LymPro Test® neuroimmunology-based flow cytometry assay for Alzheimer’s Disease (AD), offers an early, accurate, and scalable diagnostic result for physicians seeking to provide the best information and treatment plan for patients from the earliest stages of this devastating disease. It is estimated research and development activity spending exceeds $2B annually in Alzheimer’s. It is estimated the market opportunity for LymPro in the investigational setting is over $100M annually. LymPro is already being made available to the AD research and development community under an Investigational Use Only (IUO) designation via a services agreement between Amarantus and ICON Central Laboratories. The combined company expects to maintain the relationship with ICON and expand research activities in Alzheimer’s.

SOURCE Amarantus BioScience Holdings, Inc.