Unilife Corp. (UNIS-NASDAQ) has recently announced its financial results for the three months ended September 30, 2010, which marked the end of the Company’s first quarter of fiscal 2011. During the quarter, Unilife continued to advance the industrialization program for its Unifill™ glass-barreled, prefilled safety syringe. The Company intends to move into a new global headquarters and production facility during December 2010. As a result, supply of the Unifill™ Syringe to sanofi-aventis SA (SNY-NYSE) could begin in early 2011 (one year ahead of schedule), with high-volume manufacturing likely to be in place by the end of 2011.
Sanofi-aventis, thought to be the world’s largest purchaser of prefilled syringes, has been funding up to $38.5 million (pre-sales) for industrialization and exclusive right to buy the Unifill™ Syringe in therapeutic areas such as vaccines and antithrombotics. Unilife aims to establish further sales agreements with other pharmaceutical companies in areas not reserved for sanofi-aventis.
With regard to another of Unilife’s product lines, the Unitract™ 1mL line of plastic-barreled, clinical safety syringes, the Company commenced U.S. sales of these syringes last week. Unilife and Independent Medical Co-Op, Inc., a co-op of independent medical device distributors, entered into an agreement to introduce the Unitract™ 1mL syringes to healthcare facilities, with a focus on physician and long-term care.
Unilife reported first quarter fiscal 2011 revenues of $3.5 million versus $3.1 million for the same period in fiscal 2010. Net loss for the three months ended September 30, 2010, was $7.2 million, or ($0.14) per diluted share, versus a net loss of $2.1 million, or ($0.06) per diluted share, for the year-ago term. The increase in net loss was attributable to higher payroll and related expenses due to workforce increases, higher share-based compensation expense, and increased R&D expenses to finalize the product specifications of the Unifill™ syringe.
As of September 30, 2010, Unilife held cash, cash equivalents, and restricted cash of $16 million, which included $7 million of restricted cash used to secure a bridge financing for the new building. As well, in October 2010, the Company secured an $18 million mortgage from Metro Bank to support the new facility and the U.S. Department of Agriculture (USDA) agreed to guarantee $10 million of the loan.
For further information on Unilife Corp., please refer to our Research Library page.
After the close of business today, we published a 12-page Quarterly Update on CorMedix Inc. (CRMD-NYSE Amex), a company that has been under our coverage since August 2010. CorMedix recently announced its financial results for the third quarter and year-to-date period of 2010, which are profiled in our update along with a full summary of the Company’s business, lead product initiatives, latest milestones, and near-term goals. This research is complementary for visitors of our website. Visit our Research Library and click on the 11/16/2010 report uploaded on CorMedix, available here.
- During the third quarter 2010, CorMedix continued advancing patient enrollment in its Phase II deferiprone trial, entered the final stages of manufacturing scale-up for Neutrolin®, and was awarded federal grants of $488,959.
- Both Neutrolin® and deferiprone have previously shown safety and efficacy, which CorMedix believes may mitigate some of the risk associated with drug development. While neither product is yet approved for use in the U.S., taurolidine (the active antimicrobial component in Neutrolin®) has been employed for nearly 10 years in Europe and deferiprone has a 15-year history.
- Roughly six million people in the U.S. have simultaneous heart problems and CKD, which increases their risk of death and other complications, such as CIN. Additionally, U.S. physicians insert five million CVCs every year, which can lead to infection, blood clots, patient illness, limited catheter life, and increased healthcare costs.
- The Company’s leadership blends science and commercial expertise, which CorMedix believes is necessary to bring its products to market. Management is supported by a Board of Directors skilled in investment, commercial, and clinical fields, as well as multiple Advisory Boards. As well, in August 2010, Drs. Robert D. Hopkins and Dilip Wadgaonkar joined CorMedix as head of clinical operations and project management and head of product development and manufacturing, respectively.
- The Company holds exclusive rights to more than 20 patents and patent applications globally.
- CorMedix had cash and cash equivalents of $9.5 million at September 30, 2010, which the Company believes is sufficient to meet planned clinical development and operating requirements through the first quarter 2012.
As part of the Patient Protection and Affordable Care Act of 2010, Congress established a program known as the Qualifying Therapeutic Discovery Project (QTDP) to offer tax credits or grants for projects that show significant potential to produce new and cost-saving therapies, support jobs, and increase the U.S.’s competitiveness. Under the program, a total of $1 billion is allocated for credits and grants.
Grants under the QTDP represent an important source of non-dilutive funding for several of our covered companies. Both Advaxis, Inc. (ADXS-OTC.BB) and CorMedix Inc. (CRMD-NYSE Amex) have applied for and received funding under this program, as announced in November 2010.
Advaxis was credited $244,479, which will help support its ongoing Phase II trials of ADXS11-001 in cervical cancer. Advaxis is developing live, attenuated Listeria monocytogenes (Listeria) into safe, effective cancer immunotherapies. Today, the company has nine distinct, cancer-fighting constructs in development with four clinical trials in progress and two Cooperative Research and Development Agreements (CRADA) in place with the National Cancer Institute and the Department of Homeland Security.
CorMedix, focused on preventing and treating cardiorenal disease, was awarded two QTDP grants totaling $488,959 for its Neutrolin® and deferiprone programs. Deferiprone, a generic pharmaceutical available in over 50 countries for removing iron from the body, began a Phase II trial in the U.S. in June 2010. Neutrolin® is a catheter lock solution for chronic central venous catheters (CVCs), which are a type of catheter commonly used by hemodialysis patients. CorMedix is working to submit an Investigational Device Exemption (IDE) application to the FDA for Neutrolin® by the end of 2010.
If you wish to learn more about either Advaxis or CorMedix, please visit our Research Library page for complementary research on both companies. In particular, make sure to download a copy of the 60-page Executive Informational Overview on CorMedix (published in August 2010), which details the company’s business, markets, competitors, and strategies.
Several companies within our Research Library this week reported financial results, including Pro-Pharmaceuticals, Inc. (PRWP-OTC), Authentidate Holding Corp. (ADAT-NASDAQ), Antares Pharma, Inc. (AIS-NYSE Amex), and Bioniche Life Sciences Inc. (BNC-TSX).
On November 12, 2010, Pro-Pharmaceuticals, Inc. announced financial results for the third quarter and nine months ended September 30, 2010. Pro-Pharmaceuticals is developing therapeutics to treat cancer and fibrosis by targeting Galectin receptors, which have been shown to have a role in cancer and cell development. Pro-Pharmaceuticals recently shipped the first commercial order of its lead product candidate, DAVANAT®, to Colombia-based PROCAPS S.A., which the company believes could facilitate approvals in other South American countries. As well, Pro-Pharmaceuticals is preparing to commence a Phase lll trial in the U.S. using DAVANAT® in colorectal cancer patients.
On November 11, 2010, Authentidate Holding Corp., a global provider of secure health information exchange, workflow management services, and telehealth solutions, reported financial results for its first quarter fiscal 2011 ended September 30, 2010. The company also announced several projects for its Inscrybe® Healthcare platform and ExpressMD™ Electronic House Call™ monitoring solutions, including Lehigh Valley Respiratory Care, Primary Wound Care Specialists, LLC, and a telehealth distribution agreement with Rotech Healthcare Inc. Further, in October 2010, the company completed a private placement for net proceeds of approximately $4.5 million.
On November 10, 2010, Antares Pharma, Inc., a pharmaceutical company offering self-injection products and topical gel-based medicines, announced financial results for the third quarter ended September 30, 2010. The company’s product revenues increased 79%, from $0.9 million in the third quarter 2009 to $1.7 million for the corresponding 2010 timeframe. Milestones for the quarter included the announcement of positive results from a pivotal Phase III study of Anturol® Gel—a therapy designed to treat overactive bladder (OAB) symptoms—after meeting its primary endpoint of significantly reducing urinary incontinence episodes in both evaluated doses.
Also on November 10, 2010, Bioniche Life Sciences Inc., a Canadian biopharmaceutical company operating in the human and animal health markets, announced financial results for the first quarter FY 2011 ended September 30, 2010. The company and its development partner, Endo Pharmaceuticals Inc. (ENDP-NASDAQ) are finalizing the protocol for a second Phase III clinical trial with Urocidin™, a therapy for non-muscle-invasive bladder cancer. Bioniche expects to begin enrolling patients for this trial in 2010. As well, analysis of data from the first Phase III clinical trial is nearing completion.
After the close of the market today, we published an updated Executive Informational Overview on Applied DNA Sciences, Inc. (APDN-OTC.BB). Follow the jump for a brief overview of Applied DNA or visit our website at www.crystalra.com to access the full 68-page report at no charge. As well, join our mailing list to be notified of new future report releases.
Applied DNA Sciences, Inc. (“Applied DNA” or “the Company”) provides DNA-based security and authentication solutions to protect products, brands, and intellectual property from theft, counterfeiting, fraud, and diversion. DNA evidence is trusted by police and recognized by courts worldwide. Used by forensic laboratories, including the FBI, DNA authentication is absolute with a margin of error close to zero.
Applied DNA markets several security platforms, for which its pipeline may include as many as 50 to 60 projects at any time. The Company’s SigNature® DNA platform is used to embed products, such as inks, dyes, textile treatments, thermal ribbon, thread, varnishes, and adhesives, with botanical DNA markers that have been highly customized from plant DNA. These traceable markers identify original products and cannot be copied or reverse engineered. Over 600 million products to date have employed this DNA technology. The ability to incorporate DNA markers directly into individual goods makes SigNature® DNA applicable to many industries, including cash-and-valuables-in-transit (CViT), textiles and apparel, secure documents, pharmaceuticals, wine, and luxury items.
A second platform, BioMaterial Genotyping, is used to determine the authenticity of natural materials used in finished products by detecting and identifying their genomic DNA. Applied DNA’s technologies may offer several advantages over alternatives: (1) resistance to replication; (2) forensic capabilities that can be used to prosecute counterfeiters; (3) low error rates; and (4) affordability.</p