|Incyte Announces Positive Phase II Clinical Trial Results of Oral JAK1; Cerus Reports Third Quarter 2013 Results|
|By Staff and Wire Reports|
|Tuesday, 29 October 2013 20:06|
Incyte Corporation (Nasdaq: INCY) announced results from a 12-week, placebo-controlled, dose-escalation Phase II proof-of-concept clinical trial involving 60 patients with active rheumatoid arthritis for its proprietary oral JAK1 inhibitor. These results were presented today at the 2013 American College of Rheumatology / Association of Rheumatology Health Professionals (ACR/ARHP) Annual Scientific Meeting being held in San Diego, CA, from Oct. 25 to 30, 2013.
“Along with our recently presented data with INCB39110 in psoriasis, results from this study in rheumatoid arthritis demonstrate the potential of JAK1 inhibition in inflammatory indications,” stated Richard S. Levy, Incyte's Executive Vice President and Chief Drug Development and Medical Officer.
In this initial Phase II trial, 12 weeks of treatment with INCB39110 showed efficacy at all doses as measured by ACR 20, ACR 50, ACR 70, and DAS 28 as compared to placebo. Clinical benefit was observed as early as one week of treatment, and the highest dose tested, once-daily 600 mg, appeared to be the most effective dose. Below is a summary of the key efficacy endpoints evaluated at 12 weeks:
Cerus Corporation (NASDAQ:CERS) today announced financial results for the third quarter and nine months ended September 30, 2013.
"This past quarter, we continued to submit INTERCEPT plasma and platelet PMA modules on schedule, and look forward to completing these submissions in November 2013 and March 2014, respectively," said William Obi Greenman, Cerus president and chief executive officer. "Our $10.5 million in Q3 product revenue provides steady progress toward our projected full year revenue guidance of $41-$43 million."
Revenue: Product revenue for the third quarter of 2013 was $10.5 million, a 28% increase over the third quarter of 2012. Increased deployment of illuminators in several geographies, as well as elevated sales of plasma disposable kits and to a lesser extent, a stronger Euro compared to the U.S. dollar, drove third quarter revenue growth.
Product revenue for the first nine months of 2013 was $30.4 million, and represented a 16% increase from the same period in 2012. The increase in product revenue during the first nine months of 2013 over 2012 was driven primarily by increased demand for our INTERCEPT products, particularly plasma disposable kits and to a lesser extent, a stronger Euro compared to the U.S. dollar.
Gross Margins: Gross margins on product sales for the third quarter of 2013 were 35%, compared to 47% for the third quarter of 2012. Gross margins during the third quarter of 2013 were negatively impacted by certain period charges and the mix of products sold relative to the prior year. Gross margins were 42% for the first nine months of 2013, compared to 41% for the same period in 2012.
Operating Expenses: Total operating expenses for the third quarter of 2013 were $12.1 million, compared to $8.2 million for the third quarter of 2012; and $33.3 million for the nine months ended September 30, 2013 compared to $24.5 million for the same period in the prior year. The year-over-year increase in operating expenses for both the three and nine months ended September 30, was due primarily to regulatory activities for the preparation and submission activities supporting the Companys PMA submissions for INTERCEPT plasma and platelets, costs for the clinical activities regarding the Companys red blood cell program and increases in selling, general and administrative expenses in support of the existing European commercial business and preparatory market research activities for a potential U.S. launch of the INTERCEPT Blood System for plasma and platelets. The company expects these activities to continue to drive increasing operating expenses.
Operating and Net Loss: Operating losses during the third quarter of 2013 were $8.4 million, compared to $4.3 million during the third quarter of 2012, and $20.5 million compared to $13.7 million for the nine months ended September 30, 2013 and 2012, respectively. Despite the increased product revenues reported during both the three and nine months ended September 30, 2013 compared to 2012, operating losses widened due to the increased investments made in support of our PMA submission activities and our clinical activities with respect to our red blood cell program during the same periods.
Net loss for the third quarter of 2013 was $20.5 million, or $0.29 per share, compared to a net loss of $3.5 million, or $0.08 per diluted share, for the third quarter of 2012. Net loss for the first nine months of 2013 was $37.5 million, or $0.56 per share, compared to a net loss of $14.2 million, or $0.26 per share, for the same period of 2012. Net losses were impacted by the mark-to-market adjustments of the Company's outstanding warrants to fair value. These adjustments resulted in non-cash charges of $12.4 million during the third quarter of 2013 compared to a gain of $0.9 million during the third quarter of 2012 and non-cash charges of $16.8 million compared to non-cash gains of $0.1 million during the nine months ended September 30, 2013 and 2012, respectively.
Cash and Cash Equivalents: At September 30, 2013, the Company had cash and cash equivalents and short-term investments of $53.3 million compared to $26.7 million at December 31, 2012 and $58.2 million at June 30, 2013. The Companys $7.0 million revolving line of credit remains outstanding with approximately $3.4 million available for future borrowing.
Recent Highlights: INTERCEPT platelet PMA initiated with submission of first module in September 2013; remaining module submissions scheduled for December 2013 and March 2014. Third of four modules of INTERCEPT plasma PMA submitted in August 2013; submission of final module planned for November 2013. Daniel Swisher appointed Chair of Cerus Board of Directors to replace BJ Cassin, who will retire at year end.
QUARTERLY CONFERENCE CALL: The Company will host a conference call and webcast at 4:15 p.m. Eastern time today to discuss its financial results and provide a general business overview and outlook. To access the live webcast, please visit the Investor Relations page of the Cerus website at http://www.cerus.com/ir. Alternatively, you may access the live conference call by dialing 866-235-9006 (U.S.) or 631-291-4549 (international).
A replay will be available on the companys web site, or by dialing 855-859-2056 (U.S.) or 404-537-3406 (international) and entering conference ID number 31979526. The replay will be available approximately three hours after the call through November 11, 2013.
Acasti Pharma (Nasdaq:ACST) (TSX‑V:APO), a Neptune Technologies & Bioressources Inc.'s ("Neptune") subsidiary, announces that the U.S Patent & Trademark Office (the "USPTO") has allowed Acasti's composition and use patent application entitled Concentrated Therapeutic Phospholipid Compositions (the "Patent") (Publication number: US20110160161).
Alcobra Ltd. (Nasdaq:ADHD), an emerging biopharmaceutical company primarily focused on the development and commercialization of its proprietary drug, MG01CI (Metadoxine extended-release), to treat cognitive dysfunctions, such as ADHD and Fragile X Syndrome, today announced that the underwriters of its previously announced public offering of 2,000,000 ordinary shares have exercised their option to purchase an additional 300,000 ordinary shares at $16.50 per share to cover over allotments, bringing total gross proceeds from the offering to approximately $38,000,000, before deducting underwriting discounts and commissions and other offering expenses payable by the Company.
AMAG Pharmaceuticals, Inc. (Nasdaq:AMAG) today announced the appointment of Robert F. Kaper, M.D. to the role of senior vice president of medical and scientific affairs (recently vacated).
AngioDynamics (Nasdaq:ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, today announced EU CE Mark approval for its AngioVac venous drainage cannula and cardiopulmonary bypass circuit for use during extracorporeal bypass for up to six hours.
Arno Therapeutics, Inc. (OTCQB:ARNI), a clinical stage biopharmaceutical company focused on the development of oncology therapeutics, today announced data from a preclinical study supporting further evaluation of its lead compound onapristone as a potential treatment for castration-resistant prostate cancer (CRPC).
Baxano Surgical, Inc. (Nasdaq:BAXS), a medical device company focused on designing, developing and marketing minimally invasive products to treat degenerative conditions of the lumbar spine, today announced that the United States Patent and Trademark Office has issued US Patent 8,568,306 covering the direct visualization approach of the VEO® Lateral Access and Interbody Fusion System.
BioTelemetry, Inc. (Nasdaq:BEAT) will release its third quarter 2013 earnings on Tuesday, November 5, 2013 at 4:00 PM Eastern Time.
CEL-SCI Corporation (NYSE MKT: CVM) today announced that it has signed a co-development and profit sharing agreement with Ergomed Clinical Research Ltd. for CEL-SCI’s investigational immunotherapy drug Multikine (“Leucocyte Interleukin Inj.”) in HIV/HPV co-infected men and women with peri-anal warts.
Cempra, Inc. (Nasdaq:CEMP), a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, today reported financial results for the third quarter and nine months ended September 30, 2013.
Cleveland BioLabs, Inc. (Nasdaq:CBLI) today announced that on November 6, 2013, it will report its financial results for the third quarter and nine-month periods ended September 30, 2013, and will host a conference call at 10:00 a.m. ET.
Compuware Corporation (Nasdaq:CPWR), the technology performance company, was selected to the honor roll of the 2013 Michigan's Healthiest Employers program.
Covance Inc. (NYSE: CVD) today reported results for its third quarter ended September 30, 2013. Net revenue was $606.7 million, representing 11.4% growth from the third quarter of 2012's GAAP result of $544.8 million, and 12.0% growth from the third quarter of 2012's pro forma result of $541.9 million.
DS Healthcare Group, Inc. (NASDAQ:DSKX), a leading developer of personal care products, today announced it has filed a patent application titled, "Compositions and Methods for Treatment of Hair Loss," with the United Stated Patent and Trademark Office.
DSM Pharmaceutical Products, the custom manufacturing and technology business of Royal DSM (NYSE, Euronext: DSM KON), today officially opens its new cGMP facility for biopharmaceutical contract manufacturing in Brisbane, Australia.
Five Prime Therapeutics, Inc. (Nasdaq:FPRX), a clinical-stage biotechnology company focused on discovering and developing novel protein therapeutics for cancer and inflammatory diseases, will report its third quarter 2013 financial results on Tuesday, November 12, 2013, after the U.S. financial markets close.
IncellDx, Inc. announced today that they have entered into an agreement with Bristol-Myers Squibb Company (NYSE:BMY) related to the development of an assay for potential application in a molecular companion diagnostic intended to identify patients likely to benefit from treatment with a Bristol-Myers Squibb drug that is currently under development.
Innovus Pharmaceuticals, Inc., (OTCBB:INNV), today announced that the Company filed its Product License Application with Health Canada to market its premature ejaculation topical treatment EjectDelayTM.
InspireMD, Inc. (NYSE MKT: NSPR), a leader in embolic protection stents, today announced new 12-month results from the MASTER (MGuard for Acute ST Elevation Reperfusion) trial demonstrating that the MGuard outperformed bare metal and drug eluting stents in all-cause mortality in ST segment elevation myocardial infarction (STEMI) patients.
LifeVantage Corporation (Nasdaq:LFVN), a company dedicated to helping people achieve healthy living through a combination of a compelling business opportunity and scientifically validated products, announced today that it will release financial results for its first fiscal quarter ended September 30, 2013, after the market closes on Thursday, November 7, 2013.
LifeVantage Corporation (Nasdaq:LFVN), a company dedicated to helping people achieve healthy living through a combination of a compelling business opportunity and scientifically validated products, announced it has entered into a long-term, multi-million dollar jersey-front sponsorship with Real Salt Lake of Major League Soccer.
Merge Healthcare Incorporated (Nasdaq:MRGE), a leading provider of clinical systems and innovations that seek to transform healthcare, today announced that Imaging Healthcare Specialists (IHS), San Diego's leader in outpatient diagnostic imaging, has chosen Merge for its end-to-end ambulatory radiology solutions, including the radiology information system (RIS) and picturing archiving communication system (PACS), as well as for its interoperability solutions, including a vendor-neutral archive (VNA), to reduce costs and improve patient and physician satisfaction.
MRI Interventions, Inc. (OTCQB:MRIC) announced today that it will release its third quarter 2013 financial results on Tuesday, November 12, 2013, after the close of the U.S. financial markets.
Myriad Genetics, Inc. (Nasdaq:MYGN) today announced that it has launched a new prognostic test, Myriad myPlan Lung Cancer, for patients diagnosed with early-stage lung adenocarcinoma.
NanoString Technologies, Inc. (Nasdaq:NSTG), announced today that its management is scheduled to present at the Credit Suisse 2013 Healthcare Conference in Phoenix on Tuesday, November 12, 2013 at 8:30 am MT/ 10:30 am ET.
Neurocrine Biosciences, Inc. (NASDAQ: NBIX) today announced its financial results for the quarter ended September 30, 2013.
NuVasive, Inc. (NASDAQ: NUVA), a medical device company focused on developing minimally disruptive surgical products and procedures for the spine, announced today financial results for the quarter ended September 30, 2013.
OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED), a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, today announced that it has started a multi-center Phase 1b clinical trial of its first-in-class Wnt-pathway-targeting antibody vantictumab (OMP-18R5) with paclitaxel in breast cancer.
PAREXEL International Corporation (NASDAQ: PRXL) today reported financial results for the first quarter Fiscal Year 2014, which ended on September 30, 2013.
Premier, Inc. (Nasdaq:PINC) is one of only twelve organizations that have been named to Modern Healthcare's list of the Best Places to Work in Healthcare for the fifth year in a row.
Premier, Inc. (Nasdaq:PINC) today announced it plans to report fiscal 2014 first-quarter results after the market closes on Monday, November 11, 2013, followed by a conference call on Tuesday, November 12, 2013, at 8 a.m. ET.
QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) announced results of operations for the third quarter and first nine months of 2013, delivering sales growth in all regions and customer classes along with improved profitability.
Rockwell Medical, Inc. (NASDAQ: RMTI), a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron deficiency, secondary hyperparathyroidism and hemodialysis, announced today that it will hold its quarterly conference call to discuss third quarter financial results on Tuesday, November 5, 2013 at 4:15pm Eastern Time.
Stereotaxis, Inc. (Nasdaq:STXS) announced today that it has fixed 5:00 p.m. New York City time on October 31, 2013 as the record date for determination of stockholders (and eligible warrant holders) entitled to participate in its previously-announced rights offering.
Sunshine Heart, Inc. (Nasdaq:SSH) announced today that the initial C-Pulse® System patient data of its ongoing OPTIONS HF EU trial, will be presented by Professor Thomas Krabatsch, Director of Mechanical Circulatory Support at the German Heart Institute, Berlin to the investment community at Sunshine Heart's third annual analyst breakfast event, held this morning at 7:30 a.m. PDT at the W Hotel San Francisco.
Stemline Therapeutics, Inc. (Nasdaq:STML) and The Leukemia & Lymphoma Society® (LLS) today announced their collaboration to accelerate the development of SL-401 for the treatment of acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare hematological disorder with both leukemic and lymphomatous characteristics.
StemCells, Inc. (Nasdaq:STEM) today announced the acquisition of a portfolio of issued US and Canadian patents to which it had previously held an exclusive worldwide license.
Tauriga Sciences Inc. (OTCQB:TAUG), a diversified company focused on generating profitable revenues through license agreements and the development of a proprietary technology platform in the nano-robotics space, has today announced the execution of a comprehensive Strategic Alliance Agreement ("the Agreement") with Cincinnati, Ohio-based synthetic biology pioneer Bacterial Robotics, LLC. ("Bacterial Robotics").
Urologix®, Inc. (OTCQB:ULGX), the leading provider of in-office procedures for the safe, durable and effective treatment of BPH, today reported financial results for its fiscal year 2014 first quarter ended September 30, 2013.
Utah Medical Products, Inc. (Nasdaq:UTMD) announces that its Board of Directors approved a quarterly cash dividend of twenty-five cents ($.25) per share of common stock payable on December 30, 2013 to shareholders of record at the close of business on December 16, 2013.