|Aduro Receives Milestone Payment From Janssen for ADU-214; OncoGenex Announces EMA Support for Phase 3 AFFINITY Trial|
|By David Fowler|
|Thursday, 08 October 2015 18:47|
Below is a look at some of the headlines for companies that made news in the healthcare sector on October 8, 2015.
Aduro Biotech, Inc. (NASDAQ: ADRO) announced it has received a milestone payment from Janssen Biotech, Inc. for Aduro's submission of an Investigational New Drug (IND) Application to the U.S. Food and Drug Administration for ADU-214, a LADD immunotherapy in development for the treatment of non-small cell lung cancer. The IND will enable Janssen, Aduro's license partner for ADU-214, to initiate a multi-center Phase 1 trial to evaluate the safety and immunogenicity of intravenous administration of ADU-214.
"We are pleased to support Janssen in their advancement of ADU-214 into clinical trials in non-small cell lung cancer," said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. "We believe there is tremendous potential with our LADD immunotherapy platform and our partnerships, like this one with Janssen, supplement our own efforts and provide additional resources to evaluate the clinical value of our technology in multiple tumor types."
Janssen expects to initiate a Phase 1 trial by the end of 2015 to evaluate the safety and immunogenicity of intravenous administration of ADU-214 in patients with non-small lung cancer.
In October 2014, Aduro entered into its second agreement with Janssen Biotech, Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, granting an exclusive, worldwide license to ADU-214 and other product candidates engineered for the treatment of lung cancer and certain other cancers based on its novel LADD immunotherapy platform. Under the agreement facilitated by the Johnson & Johnson Innovation center in California, Aduro received a $30 million up-front payment and a milestone payment associated with submission of the IND, and is eligible to receive future development, regulatory and commercialization milestone payments up to a potential total of $786.5 million. In addition, Aduro is eligible to receive royalties at a rate ranging from high single-digits to low teens on worldwide net sales upon successful launch and commercialization.
OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) announced the European Medicines Agency (EMA) has completed its review of the proposed amendment to the company's Phase 3 AFFINITY protocol and statistical analysis plan. The amendment, which was agreed to by the U.S. Food and Drug Administration (FDA) earlier this year, includes the addition of a co-primary endpoint designed to prospectively evaluate the survival benefit of custirsen in men who are at increased risk for poor outcomes when treated with cabazitaxel for metastatic castrate-resistant prostate cancer (mCRPC). The EMA supported plans for prospectively defining a poor prognostic subpopulation in the Phase 3 AFFINITY trial and suggested additional supportive analyses to show benefit for the poor prognostic subpopulation beyond the broader AFFINITY trial population. Following support from the FDA and EMA, the company is proceeding with its planned protocol amendment globally.
"We are pleased that we now have feedback from both U.S. and European regulatory authorities on our plan to prospectively evaluate this group of mCRPC patients who have increased risk factors for poor outcomes and who therefore are more likely to have shorter survival times," said Cindy Jacobs, PhD, MD, Chief Medical Officer and Executive Vice President of OncoGenex. "As we continue to gather insights from the SYNERGY trial, we are gaining a better understanding of the role clusterin plays in this vulnerable patient group and how custirsen may provide a survival benefit."
OncoGenex, in collaboration with study investigators, has defined a simple five-criteria characterization for poor prognostic patients with prostate cancer to be treated with custirsen based on the Phase 3 SYNERGY trial, which includes: 1) poor performance status, 2) elevated prostate specific antigen (PSA), 3) elevated lactate dehyrdogenase (LDH), 4) decreased hemoglobin and 5) the presence of liver metastasis. AFFINITY patients with poor prognosis will be identified as having two or more of these five well-recognized high-risk criteria. The proposed change for AFFINITY is also consistent with custirsen's mechanism of action, as custirsen was designed to address treatment resistance which may be more prevalent in this subpopulation.
In the revised statistical analysis plan for the AFFINITY trial, the hypothesized hazard ratio (HR) for the poor prognosis subpopulation is specified to be 0.69 with the critical HR ≤ 0.778. The hypothesized HR for intent-to-treat patients (ITT population) remains unchanged as 0.75 with the critical HR ≤ 0.820.
Timing for the final analysis of the poor prognosis subpopulation is projected to occur by the end of 2015, while the final analysis of the ITT population is projected to occur in the second half of 2016. An interim analysis of the ITT population will coincide with the final analysis of the poor prognosis subpopulation. This interim analysis will have both futility and early efficacy criteria defined for the ITT population. If the final analysis of the poor prognostic subpopulation shows a survival benefit for custirsen, OncoGenex may initiate a regulatory submission.
A retrospective analysis of data from the Phase 3 SYNERGY trial presented earlier this year showed a benefit with custirsen therapy when added to first-line docetaxel chemotherapy in men with mCRPC who had a poor prognosis. The analysis showed that over 40 percent of men in the SYNERGY trial had at least two of the five common risk factors for poor prognosis as stated above. In these men, the analysis found a 27 percent lower risk of death when custirsen was used in combination with first-line docetaxel compared to docetaxel alone.
In addition, exploratory SYNERGY data analyses recently presented at the 2015 European Cancer Congress (ECC 2015) demonstrated that custirsen treatment significantly lowered serum clusterin (sCLU) levels from baseline in men with mCRPC. In addition, these data showed that sCLU reductions after custirsen treatment resulted in higher two-year survival rates in patients who were at increased risk for poor outcomes. Of those patients with lower sCLU levels, the data also showed a correlation to an overall survival benefit for custirsen-treated patients who were at increased risk for poor outcomes.
AFFINITY is being conducted at 95 global clinical trial sites. Earlier this year, the IDMC recommended the trial continue following the completion of an interim futility analysis. The trial is fully accrued and the protocol amendment does not affect the conduct of the study. Custirsen has Fast Track designation by the FDA for the poor prognosis and overall AFFINITY trial populations, as well as non-small cell lung cancer (NSCLC).
BioCorRx, Inc. (OTCQB:BICX), developer of the BioCorRx® Recovery Program, a Medication-Assisted Treatment (MAT) program, announces a new distribution agreement with an existing wellness center in the Atlanta area. The agreement is part of the Company’s continued focus to distribute its addiction treatment program specific to long-lasting Naltrexone therapy to wellness centers nationally through a partnership with Myriad Medical Marketing (MMM). The new center, Superior Health Care LLC, is run by Dr. Steve Peyroux and is located at 2050 Cumming Way, #100 Canton, GA 30115. “The availability of our newly rebranded program, the BioCorRx® Recovery Program, in this new clinical setting in the heavily populated Southeast is great news for those suffering from addiction in that area of the country. These individuals will soon have access to the benefits of our program in an environment that offers many other services that can be beneficial to them during their recovery,” says BioCorRx COO & interim CEO, Brady Granier.
BioNano Genomics, the leader in physical genome mapping, today announced that the Company has entered into a research collaboration agreement with the University of California, Los Angeles (UCLA). The research is intended to study the role of structural variations in human genetic pediatric disorders using BioNano Genomics' revolutionary genome mapping platform, the Irys® System. Principal investigator of this collaboration will be Dr. Eric Vilain, M.D., Ph.D., of the David Geffen School of Medicine at UCLA. Previously, Dr. Vilain led a study that investigated 814 cases with presumed genetic disorders that have remained undiagnosed despite exhaustive testing efforts. This study mainly focused on sequencing the protein coding regions of a patient's genome to uncover any genetic influences on disease. The results obtained from the study indicated that only 26% of the patient population showed molecular diagnosis. Technologies including next-generation sequencing (NGS) were unsuccessful in identifying the cause of genetic disorders in the remaining 74% of the study patient population.
Caladrius Biosciences, Inc. (NASDAQ:CLBS), a company combining a leading cell therapy service provider with a therapeutics pipeline including a Phase 3 clinical program in immuno-oncology and a portfolio of earlier clinical phase projects in immune modulation and ischemic repair, announces the promotions of Joseph Talamo from Vice President, Corporate Controller and Chief Accounting Officer to Chief Financial Officer and Todd Girolamo, Esq. from Vice President, Legal to General Counsel. In addition, the Company announces that Robert S. Vaters, is no longer serving as an employee of the Company and has resigned from the Company’s board of directors. “Bob Vaters joined Caladrius in January 2015 to help me accelerate the Company’s near-term organizational and strategic evolution. He has been instrumental in identifying and affecting multiple changes that have contributed to the Company’s new course. We greatly appreciate the contributions he made and wish him continued success in his future endeavors,” said David J. Mazzo, Ph.D., Chief Executive Officer of Caladrius Biosciences. “We are delighted to promote Joe and Todd, both experienced executives who have demonstrated their leadership, competence and diligence in the execution of their duties. I am confident each will continue to contribute meaningfully to the Company’s success as we expand our leadership position as the premier cell therapy service provider and advance our pipeline of clinical development programs,” added Dr. Mazzo.
CymaBay Therapeutics, Inc. (NASDAQ:CBAY), a clinical-stage biopharmaceutical company developing therapies to treat metabolic diseases with high unmet medical need, today announced that Robert J. Wills, Ph.D., a member of the Board of Directors since March 2015, has been appointed Chairman of the Board of Directors. Dr. Wills replaces retiring Chairman, Louis G. Lange, M.D., Ph.D. Dr. Lange has been a member of CymaBay's Board since 2003 and has served as Chairman since 2009. "I would like to thank Dr. Lange for his 12 years of valued leadership and service to CymaBay," said Harold Van Wart, Ph.D., Chief Executive Officer of CymaBay Therapeutics. "On behalf of the Board of Directors, we wish him well in his future endeavors. It is also my pleasure to welcome Dr. Wills as our new Chairman of the Board. Dr. Wills has had a distinguished career in the pharmaceutical industry and has already been a significant strategic asset to CymaBay since he joined our Board in March of this year. We look forward to his continued contributions to CymaBay as we remain focused on further advancing our clinical pipeline, including arfhalofenate in gout and MBX-8025 in high unmet need and orphan diseases."
Fibrocell Science, Inc., (NASDAQ:FCSC), an autologous cell and gene therapy company focused on developing first-in-class treatments for rare and serious skin and connective tissue diseases with high unmet needs, and Intrexon Corporation (NYSE:XON), a leader in synthetic biology, today announced that a poster entitled “Pre-Clinical Development of a Genetically-Modified Human Dermal Fibroblast (FCX-007) for the Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB)” will be presented at the American Society of Human Genetics Annual Meeting from October 6-10, 2015 in Baltimore, Maryland. The poster contains additional details of the previously reported positive in vivo pre-clinical data for FCX-007, Fibrocell’s orphan gene-therapy product candidate for the treatment of RDEB. RDEB is caused by a mutation of the COL7A1 gene—the gene which encodes for type VII collagen (COL7), a protein that forms anchoring fibrils to hold together the layers of skin. Without these fibrils, skin layers separate causing severe blistering, open wounds and scarring in response to any kind of friction, including normal daily activities like rubbing or scratching.
Heat Biologics, Inc. (Nasdaq:HTBX), a clinical-stage cancer immunotherapy company, announced that it has completed enrollment of the full 75 patients in the blinded, randomized, placebo-controlled arms of the Phase 2 clinical trial of HS-410 (vesigenurtacel-L) for the treatment of high-risk, non-muscle invasive bladder cancer (NMIBC). In these three arms of the Phase 2 trial, Heat is evaluating the ability of HS-410 in combination with standard of care, Bacillus Calmette-Guerin (BCG), to stimulate the immune system and eliminate remaining cancer cells to prevent recurrence. The primary endpoint for the Phase 2 trial is one-year disease free survival. As previously announced, Heat is enrolling an additional 25 patients to evaluate HS-410 as a monotherapy in an unblinded, open-label arm, which the company expects to complete by late 2015/early 2016. "This enrollment of the 75 randomized patients represents a significant milestone for the company and we continue to remain on track to report topline efficacy, immune-response and safety results in the fourth quarter of 2016," said Melissa Price, Ph.D., Vice President of Product Development, Heat Biologics. "These data will help guide the trial design, including patient selection and biomarker strategy, for our registration-directed trial as we move forward in our commitment to address the unmet needs of patients living with bladder cancer."
K2M Group Holdings, Inc. (Nasdaq:KTWO), a global medical device company focused on designing, developing and commercializing innovative and proprietary complex spine technologies, techniques and minimally invasive procedures, today announced plans to release third quarter of fiscal year 2015 financial results after market close on November 3rd. Management will host a conference call at 5:00 p.m. Eastern Time on November 3rd to discuss the results of the quarter and to host a question and answer session. Those who would like to participate may dial 888-430-8705 (719-325-2402 for international callers) and provide access code 376216 approximately 10 minutes prior to the start of the call. A live webcast of the call will also be provided on the investor relations section of the Company's website at http://Investors.K2M.com/. For those unable to participate, a replay of the call will be available for two weeks at 888-203-1112 (719-457-0820 for international callers); access code 376216. The webcast will be archived on the investor relations section of the Company's website.
LDR Holding Corporation (NASDAQ:LDRH), a global medical device company focused on designing and commercializing novel and proprietary surgical technologies for the treatment of patients suffering from spine disorders, today announced preliminary estimated revenue results for the third quarter ended September 30, 2015. For the third quarter ended September 30, 2015, the company expects to report: Total revenue of approximately $39.3 million, an increase of 9.5% over the third quarter of 2014, or an increase of 14.2% on a constant currency basis. Revenue from exclusive technology products of approximately $36.7 million, an increase of 14.5% over the third quarter of 2014, or an increase of 18.0% on a constant currency basis; Revenue in the United States of approximately $32.3 million, an increase of 15.0% over the third quarter of 2014, and representing 82.2% of total revenue; International revenue of approximately $7.0 million, a decrease of 10.3% over the third quarter of 2014. On a constant currency basis, international revenue increased 11.4%; Revenue from the Company’s exclusive cervical products is expected to be approximately $27.5 million, an increase of 21.0% over the third quarter of 2014, or an increase of 25.2% on a constant currency basis, due principally to the growth from sales of the Mobi-C® Cervical Disc. Additionally, revenue from LDR's exclusive lumbar products is expected to be approximately $9.2 million, a decrease of 1.5% over the third quarter of 2014, or an increase of 0.5% on a constant currency basis.
Through Living Beyond Breast Cancer's "Beyond the Breast" campaign, women and men are drawing attention to what it's like to live with metastatic (Stage IV) breast cancer, while advocating for better-funded research, with the hashtag #beyondthebreast. Sharing their stories on Twitter, Facebook, and LBBC's award-winning blog, some post pictures of themselves holding signs pointing to their hip, or their head, or their spine, with the words, "My breast cancer is here." There is still no cure for metastatic breast cancer, in which the cancer has spread to distant parts of the body. More than 40,000 people die of the disease each year, and a significant percentage of people diagnosed with localized cancers eventually develop metastatic disease. "Breast cancer isn't something I'm 'aware' of only during the month of October," says LBBC Board Member Ayanna Kalasunas, who has metastatic cancer. "For us, breast cancer awareness is every minute of every day, of every week, of every month of every year. We want our voices to be heard, too."
Marrone Bio Innovations, Inc. (NASDAQ:MBII), a leading provider of bio-based pest management and plant health products for the agriculture, turf and ornamental and water treatment markets, announced today that the U.S. Environmental Protection Agency has approved its latest product, MAJESTENE™, a broad spectrum, high performance natural bionematicide for controlling nematodes (roundworms) on a wide range of agricultural crops. MAJESTENE was developed from MBI's in-house discovery screening process and provides growers with a new mode of action for safely controlling nematodes by reducing or stopping eggs from hatching, preventing root galling and reducing nematode population density. Nematodes cause approximately $80 billion annually in damages to crops globally. "We are pleased with MAJESTENE'S approval by the EPA, as this new bionematicide meets a large market need due to heavy restrictions on toxic chemicals used to control nematodes and the need for easier-to-use biologicals that reduce multiple species of nematode populations," said Pam Marrone, MBI's CEO. "Today's growers are faced with ever-increasing regulatory restrictions on existing conventional products to reduce exposure to people nearby, to protect non-target beneficial insects, to reduce air and water pollution, to ensure worker safety and to be export-ready. Growers who traditionally employ conventional nematicides for crop protection can now use MAJESTENE, which has multiple modes of action, a low risk to beneficial insects, and an exemption from residue tolerances. MAJESTENE brings growers expanded options for an environmentally responsible and effective solution for managing pests in conventional and organic crops," said Brian Ahrens, MBI's Vice President of Sales.
MedAssets (NASDAQ:MDAS) today announced that Scripps Health, a non-profit regional integrated health system based in San Diego, Calif., has expanded its relationship with MedAssets to include Invoice Management Services, powered by Ariba, an SAP company. This is MedAssets newest component of its procure-to-pay solution set, and builds on Scripps Health's comprehensive program with MedAssets to reduce the total cost of care, enhance operational efficiency, align clinical delivery and improve revenue performance. MedAssets Invoice Management Services is a best-in-class solution that leverages Ariba's cloud-based invoice management applications to enable a "smart invoicing" process through which invoices are automatically validated against 80+ provider-customized validation rules to ensure that only accurate and approved invoices reach accounts payable. "Many companies have implemented solutions to digitize invoices. But with one in five invoices still containing an overcharge or other error, it's clear that digitization only leads to inaccurate invoices being delivered faster," said Alex Atzberger, president, Ariba. "MedAssets delivers an intelligent invoicing process using Ariba's Invoice Management solutions that reduces the number of invoice exceptions materially and provides true "touchless" invoice processing, resulting in significant labor efficiency gains to providers."
Medical Marijuana, Inc. (OTC Pink:MJNA), the first-ever publicly traded U.S. cannabis company, is pleased to announce to shareholders and the general public that Stuart W. Titus, PhD and Chief Executive Officer of Medical Marijuana, Inc. will be presenting on the Cannabis Investor Webcast on Thursday, October 8 at 4:00 – 4:45 PM ET (1:00 – 1:45 PM PT). The Cannabis Investor Webcast will include presentations from both privately held and publicly traded industry companies and industry professionals. Medical Marijuana, Inc.’s presentation on hemp industry innovations will be 30 minutes long and will then be followed by a 15-minute Q&A. Along with learning about economic potential of re-introducing hemp into American culture, attendees at the Cannabis Investor can research Medical Marijuana, Inc. without taking time off from work, paying registration fees and incurring travel-related expenses. “Medical Marijuana, Inc. is very excited to share an overview on the company, hemp industry innovations and other recent developments with the Cannabis Investor Webcast,” states Stuart W. Titus, PhD and Chief Executive Officer of Medical Marijuana, Inc. “With our flagship product Real Scientific Hemp Oil generating global headlines and other exciting developments from our portfolio companies that are conducting clinical research, it’s a very exciting time for the company.”
Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, today announced that new clinical outcomes and clinical utility data for myPath® Melanoma will be featured at the American Society of Dermatopathology (ASDP) 52nd meeting being held Oct. 8 to 11, 2015 in San Francisco, Calif. The findings add to the growing body of knowledge for myPath Melanoma and will support the Company's clinical reimbursement dossier for the product. "The accurate diagnosis of melanoma can be challenging based on histologic findings alone and there are potentially severe consequences of a misdiagnosis, including the under-treatment or overtreatment of patients," said Loren Clarke, M.D., vice president, Medical Affairs for Dermatology, Myriad Genetic Laboratories. "Our studies show that myPath Melanoma accurately differentiates malignant melanoma from benign skin lesions and helps physicians deliver a more objective and confident diagnosis for their patients."
SANUWAVE Health, Inc. (OTCQB:SNWV) today announced top line and preliminary data analysis from the Company's pivotal Phase III, Investigational Device Exemption (IDE) supplemental clinical trial comparing the rates of 100% wound closure at 12 weeks between dermaPACE® and Sham control (non-active treatment), when both are combined with the current standard of care for the treatment of diabetic foot ulcers (DFUs). This study supplemented the Company's earlier 206 patient Phase III trial of identical endpoints which demonstrated the exceptional safety profile and clinical benefit of the dermaPACE device for the treatment of diabetic foot ulcers; an area of significant unmet medical need and represents a $2 billion market in the United States alone. The design of this randomized, double-blind, parallel-group, Sham-controlled, multicenter, 26-week clinical trial was intended to quantify the effectiveness of up to eight, non-invasive procedures with dermaPACE, delivered over a 10-week period. This supplemental study ultimately enrolled and randomized 130 subjects and was run under a Bayesian statistical plan, designed with FDA input and utilizing the strength of the results from the first clinical trial as an informative prior. As previously reported, the Company announced the results of two separate Data Monitoring Committee (DMC) analyses of the primary objective. In both cases, the DMC reported that the study did not meet the Monitoring Success Criterion at Week 12 necessary to stop enrollment in the trial. In essence, there was insufficient separation in the rates of closure between the dermaPACE and Sham-control patients to demonstrate statistical significance. On June 6, 2015, the company met with FDA to discuss potential analysis changes for the trial. FDA was fully aware of the DMC findings that we wouldn't meet the12 week endpoint. FDA's response at the meeting was for SANUWAVE to submit the data, and they would judge dermaPACE on the totality of the clinical results when reviewing the PMA. The clinical data was frozen and the associated database was locked in August, 2015. Subsequently the top line datasets were submitted to the Company's statisticians for analysis.
The Spectranetics Corporation (Nasdaq:SPNC) today announced that the Company will release 2015 third quarter financial results after market close on Thursday, October 22, 2015. Company management will host an investment-community conference call beginning at 2:30 p.m. Mountain Time (4:30 p.m. Eastern Time) on Thursday, October 22 to discuss those results and to answer questions. Individuals interested in listening to the conference call may do so by dialing (877) 561-2747 for domestic callers, or (973) 409-9689 for international callers (Conference ID: 48806203), or from the webcast on the investor relations section of the Company's website at: www.spectranetics.com. The webcast will be available on the Company's website for 14 days following the completion of the call.
VBI Vaccines Inc. (Nasdaq:VBIV) announced that it has applied its eVLP Platform in the development of a novel therapeutic vaccine candidate for glioblastoma multiforme. Columbia University's Brain Tumor Center is performing research to evaluate VBI's GBM immunotherapy candidate in ex vivo studies using GBM patient samples. Glioblastoma is among the most common and aggressive malignant primary brain tumors in humans. In the U.S. alone, 12,000 new cases are diagnosed each year.1 The current standard of care for GBM is surgical resection, followed by radiation and chemotherapy. Even with aggressive treatment, GBM progresses rapidly and is exceptionally lethal, with median patient survival of less than sixteen months. A growing body of research has demonstrated that GBM tumors are particularly susceptible to infection by cytomegalovirus, with over 90% of GBM tumors expressing CMV antigens. In addition, recent research has demonstrated that dendritic cell priming combined with dendritic cell vaccination against CMV can extend overall survival in patients with glioblastoma. "Recent advances in this field are promising, but there is still need for improved CMV vaccination approaches for GBM," said Dr. David E. Anderson, Ph.D., VBI's Chief Scientific Officer. "Our eVLP approach has allowed for the efficient delivery of multiple CMV antigens, and in the case of GBM, we believe could be capable of mobilizing a broad and robust anti-tumor immune response against GBM. Further, we have demonstrated the ability to manufacture eVLP-derived vaccine candidates with yields and purity that are expected to be suitable for production at a commercial scale."
WaferGen Bio-systems, Inc. (Nasdaq:WGBS) today announced preliminary, unaudited revenue for the third quarter of 2015. The Company expects total revenue for the third quarter of 2015 to be in the range of $1.9 million to $2.1 million, which would represent an increase of 52-68% when compared to the $1.3 million reported for the third quarter of 2014. This also represents a sequential increase of 18-30% compared to the $1.6 million generated in the second quarter of 2015. Revenue for the third quarter is expected to be the highest in WaferGen's history, and represents the second consecutive quarter of revenue growth. The primary driver of revenue growth was sales of the Company's SmartChipTM products and services, which comprised approximately 67% of total revenue, compared to 53% in the second quarter of 2015 and 58% in the third quarter of 2014. WaferGen is also updating the Company's full-year 2015 revenue guidance from between $7.5 million and $7.8 million, excluding sales of the recently launched ICELL8™ Single-Cell System, to between $7.8 million and $8.2 million, including ICELL8-related revenue. "The third quarter will represent both our highest ever quarterly revenue, and the Company's second consecutive quarter of revenue growth," said Rollie Carlson, President and CEO of WaferGen. "With our base business now performing well, and the recent commercial launch of our ICELL8 Single-Cell System, we are well-positioned for meaningful growth in our business." The quarterly financial results included in this press release were calculated prior to the completion of a review by WaferGen Bio-systems' external auditors and are therefore subject to adjustment. Actual revenues for the third quarter of 2015 may differ materially from our expectations.