Continuing with our "earnings season highlights" coverage, LRAD Corp. (LRAD-NASDAQ) has reported its fiscal second quarter 2013 financials, which entail results for the Company’s three- and six-month period ended March 31, 2013.
In addition to the below discussion, detailed information from Crystal Research Associates about LRAD’s business, product lines, strategies, market opportunities, and competition is available here, and the Company’s SEC filings can be accessed here.
The Company’s Long Range Acoustic Device® (LRAD®) technology uses advanced sound reproduction technologies and novel acoustic materials to broadcast authoritative and highly intelligible instructions, warnings, alarms, and other sounds over several miles. LRAD® improves upon traditional speaker systems and megaphones by directing sound only where needed. Similar to a spotlight, which produces an intense beam of targeted light, each LRAD® system delivers a focused, directional audio broadcast. The beam width, frequency range, and maximum continuous output of LRAD® devices can be adjusted to target individuals, small groups, and large crowds at various ranges. LRAD Corp.’s versatile product portfolio has a range of applications, including public safety, law enforcement, homeland and international security, private and commercial security, maritime security, and wildlife and asset protection.
LRAD’s fiscal year ends September 30th, making the three months ended March 31st the Company’s second quarter. For the quarter, LRAD reported revenue from product sales, contracts, and other sources of $3.2 million, up from $2.4 million in the year-ago period. It is important to note that LRAD’s quarterly revenue is subject to fluctuations due to the budgetary cycles of its customer base, which largely consists of domestic and foreign government, military, law enforcement, and other agencies.
Similarly, LRAD’s revenues for the six-month period ended March 31, 2013, were $6.2 million versus $6 million for the first half of fiscal 2012.
For the second quarter fiscal 2013, LRAD reported a net loss of $459,000, or ($0.01) per share, versus a net loss of $292,000, or ($0.01) per share, for the second quarter fiscal 2012. For the first half of 2013, net loss was $560,000, or ($0.02) per share, versus a net income of $22,000, or $0 per share, for the six months ended March 31, 2012. For all terms, the increase in net loss to date in FY 2013 results from higher operating expenses due to increases in legal and other professional fees associated with a recent lawsuit and threatened proxy contest, non-cash share-based compensation expense, and research and development costs, partially offset by favorable commission expense, according to LRAD’s May 8, 2013, press release.
While LRAD has recently encountered economic and defense budget headwinds as a result of sequestration and spending uncertainty, the Company has worked to mitigate these effects by expanding its acoustic hailing device (AHD) markets, launching additional LRAD® systems, pursuing a pipeline of both domestic and international business opportunities, closely controlling its balance sheet and expenses, and moving into new headquarters with increased and improved manufacturing space, among other benefits. LRAD reports that it is starting to see funds being released for acoustic hailing device (AHD) military purchases in the U.S. and anticipates strong military and international sales for the second half of the fiscal year.
As of March 31, 2013, LRAD held cash and cash equivalents of $15.8 million.
Our second post on "earnings season highlights" focuses on technology company Neonode Inc.(NEON-NASDAQ), which last week reported quarterly financials for the three months ended March 31, 2013. (For the first in this blog series—coverage of PhotoMedex, Inc.’s first quarter earnings—click here.)
In addition to the below discussion, detailed information from Crystal Research Associates about Neonode’s business, product lines, strategies, market opportunities, and competition is available here, and the Company’s SEC filings can be accessed here.
New Technology for Your Touchscreen
Neonode is a developer of infrared, multi-sensing interfaces that make handheld, consumer, and industrial electronic devices touch sensitive. The Company’s touch technology platform is branded zForce®, upon which Neonode has developed a variety of features that sense any object—its size, its pressure on a surface, its depth, its velocity, and even its proximity to the surface. This feature set is called Neonode MultiSensing® touch technology, which represents a newer alternative to standard capacitive touch solutions (such as is used on the iPad®). To date, the Neonode MultiSensing® solution has been used on more than 10 million touch-enabled consumer devices worldwide, including in a Kindle Touch eReader from Amazon.com, Inc., the Nook eReader from Barnes & Noble, Inc., eReaders from Sony Corp., Kobo Inc., and several other manufacturers, and in the MEEP! tablet from Oregon Scientific Inc. The technology has also been licensed for a variety of other consumer electronics and automotive solutions, including to Alpine Electronics, Inc., BYD Co. Ltd., and One Laptop per Child, among other companies in the tablet PC, mobile phone, office equipment, and automotive sectors.
No Screen? No Problem!
The zForce® technology is display agnostic, indicating that it can be added to a variety of surfaces, including liquid-crystal display (LCD), electronic ink (e-ink), organic light-emitting diode (OLED), and electronic paper display (EPD). Accordingly, Neonode’s addressable market is considerable, comprising today’s touchscreen products as well as any product that may in the future be made touch sensitive. A visual display is not required; thus, zForce® is applicable to touchpads, keypads, door locks, appliances, industrial goods, and other items in addition to handheld consumer electronics.
Neonode operates via a technology licensing model where revenues are primarily generated through non-exclusive, royalty-based licenses to original equipment manufacturers (OEMs), original design manufacturers (ODMs), and component suppliers. In addition, the Company may offer engineering design services to its customers as well. For the first quarter 2013, Neonode reported net revenue from licenses and engineering design fees of $0.5 million, a considerable decline from the Company’s performance last year—when Neonode reported revenues of $1.2 million for the first quarter 2012.
Despite the Company’s recent decrease in revenue, Neonode appears to have been hard at work opening up future opportunities. As reported in the Company’s Form 10-Q filed on May 8th with the SEC, Neonode has signed 29 technology license agreements with global OEMs, including for many industries beyond the eReader sector. Of note, Neonode expects its customers to ramp-up production and sales of tablets, printers, and handsets in the second half of 2013, and some of the Company’s newest technology licenses signed in the first quarter 2013 are with major automotive brands. Subsequent to the quarter’s end, Neonode also signed an agreement to incorporate its MultiSensing® technology into certain ATM machines, and the Company believes that some of its key recent agreements in the PC space can lead to touch innovations for Windows® notebook PCs in the near future.
Future Technologies Are Driven by Today’s Product R&D
As Neonode seeks to open up additional sources of technology licensing revenue going forward, the Company has drastically increased its investments in research and development (R&D). Neonode reported product R&D for the first quarter 2013 of $1.6 million, up 138% over the first quarter 2012, when product R&D was only $0.7 million.
Likewise, the Company has continued its commitment to patenting its innovations, and has received three new patents in 2013. Neonode now holds 12 patents and 72 pending patent applications.
For the first quarter 2013, Neonode reported a net loss of $3.6 million, or ($0.11) per share, versus a net loss of $1.6 million, or ($0.05) per share, for the comparable quarter last year.
Quarterly earnings are in full swing and we are excited to present financial highlights for Pennsylvania-based PhotoMedex, Inc. (PHMD-NASDAQ), which were just reported for the three-month period ended March 31, 2013.
In addition to the below discussion, detailed information from Crystal Research Associates about PhotoMedex’s business, product lines, strategies, market opportunities, and competition is available here, and the Company’s SEC filings can be accessed here.
Over $57 Million in Quarterly Revenue
Global skin health company PhotoMedex has posted considerable growth since its 2011 merger with Radiancy Inc. First quarter 2013 revenue was up 14% over the companies’ first combined quarter in 2012. PhotoMedex reported quarterly revenue of $57.2 million for the period ended March 31, 2013, which included year-over-year gains in each of the following business segments: (1) consumer revenues from the innovative no!no!™ products, including increases in all consumer avenues (direct-to-consumer, global retail and home shopping, and through distributors); (2) sales and treatment revenues from the professional XTRAC® excimer laser; and (3) sales of the NEOVA® topical skin care line.
Highlights: Effective Corporate Strategies Drive Growth
Over the past year, PhotoMedex and Radiancy have executed an efficient merger, blending PhotoMedex’s expertise in physician sales and deep product line of capital equipment and topical formulations with Radiancy’s highly advanced consumer sales engine, creative marketing programs, and global distributor and retail network. Effectively leveraging these skills has been key to the Company’s growth thus far, and is expected to be a major driver of sales going forward as PhotoMedex continues to incorporate consumer marketing strategies into its professional (dermatologist- and aesthetician-targeted) sales.
As an example of this type of integration, in late 2012, PhotoMedex launched a nationwide education campaign targeted at U.S. consumers and physicians, with the intent of raising awareness of the Company’s XTRAC® tools to treat psoriasis and vitiligo patients. As part of the “Live Clear. Live Free.” Campaign, national direct-to-consumer radio and television advertising began airing in November 2012, supported by a direct mail campaign. A 24/7 call center staffed with clinical specialists provides insurance guidance, answers questions on XTRAC® therapy, and expedites appointments with physicians. In addition, the XTRAC® website,www.LiveXTRACClear.com, has been equipped with patient and physician resources, and new patient education materials were delivered to all 300 authorized XTRAC® practices nationwide. In addition to providing patients with key information about their skin diseases and treatment options, “Live Clear. Live Free.” seeks to drive awareness of XTRAC® care among a wider physician base beyond just dermatologists commonly treating psoriasis and vitiligo patients.
As a result of this push, PhotoMedex reported XTRAC® adjusted treatment revenues of $3.2 million for the first quarter 2013, an increase of 73% versus the first quarter 2012 and an increase of 22% sequentially (compared to the fourth quarter 2012). In addition, the Company’s installed base of XTRAC® machines increased by 51 placements during the quarter, for a total of 401 in the U.S.
Similarly, 2012 saw a tremendous sales and marketing effort from PhotoMedex for the consumer no!no!™ products, which included several one-day “beauty events” on home shopping TV channels that earned record revenue, a drive to place the no!no!™ products at nearly every Bed Bath and Beyond store in the U.S. as well as a number of other global retailers, Spanish-language advertisements in the U.S., and increased marketing of no!no!™ Men. To get more traction out of these expenditures, the Company worked to upsell no!no!™ customers at call centers on the NEOVA® skin care products as well, leading to increased sales of this line too.
For the first quarter 2013, PhotoMedex reported consumer revenues, led by the no!no!™ products, of $49 million, a 16% increase over the first quarter 2012.
Profitability Increasing and Solid Cash Position
For the first quarter 2013, PhotoMedex’s gross margins increased from 77.7% in the first quarter 2012 to 79.3%.
The Company reported a net income for the period of $7.2 million, or $0.34 per diluted share, versus $4.9 million, or $0.26 per diluted share, for the year-ago quarter.
As of March 31, 2013, PhotoMedex had cash and cash equivalents of $63.5 million, or $3.00 per diluted share.
We announced today that it we have issued an Executive Informational Overview (EIO) on eCharge Corp. The full 60-page report can be found here.
Cybersecurity software development firm, eCharge2 Corp. (“eC2” or “the Company”), is a closely held company focused on protecting confidential, proprietary, and personal data. In fall 2012, eC2 launched the first product from its Unbreakable Exchange Protocol™ (UXP™) platform under the SertintyONE™ brand. The UXP is an integrated, owner- and data-centric, self-aware cybersecurity platform which may begin generating revenues in the first half of 2013.
SertintyONE is designed to redefine the rules of traditional, yet outdated, firewall and data governance paradigms by improving data protection and workflow performance. The Company has a strategic alliance in place with technology provider Transformations Inc. and is working to establish additional partnerships. Through the alliance with Transformations, the UXP smart-data solution is currently available for employee and consumer confidential and critical communication workflows within the healthcare, finance, critical infrastructure, and other industries.
Five Key Reasons to Look at eCharge2
The Company believes that its cybersecurity software may alter the landscape for Identity and Access Management (IAM), Security Information and Event Management (SIEM), Data Loss Protection (DLP), Digital Rights Management (DRM), and Key Encryption Management—critical data-governance components of existing cybersecurity software. According to IBM Corp.’s estimates, security software and services is roughly a $94 billion market, expanding at a CAGR of nearly 12%. The IAM sector alone is estimated to be an $11 billion market with approximately 20% annual growth.
Factors fueling the need for improved cybersecurity protocols include a rapid expansion of mobile devices, use of social networks by enterprises, increasing privacy concerns in highly regulated industries (e.g., healthcare and finance), and a significant increase in organized, high-level cyberattacks.
The Company holds 29 issued and 25 pending patents worldwide, which protect its code and may be a source of future revenue.
The management team at eC2 is skilled in technology and software development, project finance, and bringing new brands into the commercial marketplace. Individuals come from leadership backgrounds at both private and public companies, including Oracle Corp., E. I. du Pont de Nemours and Co., Arthur Andersen LLP, Digital Equipment Corp., and Baxter Travenol Laboratories Inc., among other major enterprises.
As of March 2013, eC2 has raised over $18 million, which has largely been invested in product and technology development, intellectual property, and acquiring skilled management. The Company is currently seeking to raise an additional $25 million to fuel growth.
Yesterday, Crystal Research Associates published a 12-page Quarterly Update on MetaStat, Inc., a life sciences company developing next-generation diagnostic and therapeutic products for metastatic cancer. MetaStat is currently focused on three key initiatives within its pipeline: two diagnostic platforms (MetaSite™ Breast and MenaCalc™) as well as one therapeutic program (MenaBloc™). These candidates are overviewed on pages 5-8 of MetaStat's Quarterly Update.
MetaStat has achieved several key milestones in recent months as it continues to pursue its goals of bringing its first product candidate to market.
- In January 2013, MetaStat announced that it had completed a 500-patient confirmatory trial in breast cancer with MetaSite Breast. The Company expects data from this study to be released in mid-2013.
- MetaStat appointed David Epstein, Ph.D. as advisor for the Company’s drug discovery and development initiatives. Dr. Epstein has over 15 years of R&D experience in addition to leadership experience in both the pharmaceutical and biotech sectors. Dr. Epstein also joined MetaStat’s Board of Directors.
- The Company raised $1.3 million in gross proceeds during a private placement with accredited investors in early 2013.
MetaStat aims to achieve a number of milestones in the next 12 to 24 months for its three product candidates. With MetaSite Breast potentially entering the market in 2014, the Company is working to bolster its pipeline through the development of its two additional platforms.
Obtain results from a 500-patient large population validation study
Publish data from the validation study in leading scientific journal
Initiate one or more additional validation and chemotherapy benefit studies (cohorts identified)
Set up CLIA GLP-certified central laboratory
Commence initial pilot marketing
Initiate a large population validation study in breast cancer with metastatic risk as the primary endpoint
Perform a large-scale proof-of-concept study in prostate cancer
Execute a large-scale proof-of-concept study in adenocarcinoma of the lung
For additional information about the Company's technology platforms, news announcements, and stock information, as well as to download the 52-page Executive Informational Overview published on January 3, 2013, please see MetaStat's Corporate Profile.
On the heels of being named the "Subsea Pipeline Technology of the Year" by the Pipeline Industries Guild in March, Abakan Inc. (ABKI-OTC) announced last week that it would build a large-scale cladding facility in Brazil to target the lucrative Brazilian oil and gas markets. Abakan has entered into a memorandum of understanding (MOU) with Latin America's Cone S.A. for construction of the new CermaClad™ manufacturing facility. Cone not only possesses significant industrial construction expertise but has partnered with the U.S.'s FCL Builders, which has over 35 years of experience as a design/build contractor for industrial facilities.
Abakan's move to open a CermaClad™ plant in Brazil is part of the Company's long-term strategy for commercializing its innovative CermaClad™ and PComP™ products to meet global demand for next-generation metallic coatings and cladding solutions that improve metal’s resistance to corrosion and wear.
The Company’s nanocomposite metallic alloys can be applied to valuable metal assets in an array of multibillion-dollar industries, such as oil and gas, mining, marine, and aerospace applications, as well as infrastructure, in order to extend the life of metal components and reduce the maintenance and downtime costs of repairing corroded or worn-out parts. It is estimated that as much as 50% of the market for corrosion- and wear-resistant metal cladding is for cladding steel pipes for the oil/gas/mining industries alone, making a Latin American manufacturing facility particularly beneficial for Abakan as the Company targets this customer base. Brazil is home to one of the largest energy companies in Latin America, Petroleo Brasileiro S.A. (Petrobras), which entered into a $1.7 million joint development agreement (JDA) with Abakan in January 2011.
Abakan reports that architectural drawings are finalized and permitting for the site has begun. The facility foundation is scheduled for completion in July 2013, with Abakan able to begin installing equipment by December 2013.
Once operational, this clad pipe manufacturing plant is expected to have capacity for producing up to $200 million in clad products annually using Abakan's proprietary approach, which the Company states has shown to be 15 to 100 times faster to apply than current metal-protection techniques and offer six times greater corrosion resistance. At this size, the plant may be one of "the world's largest metallurgical clad pipe manufacturing facilities" says Abakan CEO Robert Miller.
Abakan is not stopping with the construction of a plant in Brazil. Due to widespread interest in its technologies and products (from major oil companies to shipbuilders to the Wall Street Journal, which calls CermaClad™ the top manufacturing technology globally), the Company has plans for several additional global sites to meet demand for both its CermaClad™ and PComP™ products.
For further details on Abakan, its unique technologies and their potential in the marketplace, as well as possible competitors, financial position, and the Company's strategies for navigating growth and sales agreements, download a copy of our recent research on Abakan: available here.
This morning, AtheroNova Inc. (AHRO-OTC) announced that it expanded its clinical expertise by adding Dr. Stephen Nicholls as Chair of the Company's Clinical Advisory Board. AtheroNova expects to launch its first Phase I clinical trial in the next few months for a drug called AHRO-001 to combat the accumulation of plaque in the arteries, thus the appointment of Dr. Nicholls--who has completed a postdoctoral fellowship in plaque imaging at the Cleveland Clinic and is the current heart disease Theme Leader at the South Australia Health and Medical Research Institute--is extremely well-timed. Dr. Nicholls will serve as a co-principal investigator in the upcoming clinical trial.
For more information about plaque deposits and how they ultimately block the arteries, leading to dangerous cardiovascular diseases including heart attacks, strokes, and peripheral artery disease (PAD), please refer to the Quarterly Update published April 5, 2013, on AtheroNova. It is available for download here. AtheroNova seeks to commercialize a treatment that could actually reverse plaque accumulations, rather than simply slow them as most medicines today do.
About Stephen Nicholls, M.B.B.S., Ph.D.
Dr. Nicholls brings to AtheroNova a wealth of experience in the imaging and analysis of cardiovascular plaque. His research emphasis includes the functional properties of HDL, the role of inflammation and oxidative stress in atherogenesis, and the development of new imaging modalities to assess factors that influence the natural history of atherosclerosis. He has had a lead role in clinical trials that employ intravascular ultrasound to investigate the impact of novel anti-atherosclerotic therapies, and is a Professor of Cardiology at the University of Adelaide (Australia) as well as a Consultant Cardiologist at the Royal Adelaide Hospital.
Dr. Nicholls was appointed heart disease Theme Leader at the South Australia Health and Medical Research Institute (SAHMRI) in May 2012 in conjunction with the Heart Foundation as a direct effort of the Australian government to provide research in one of the leading causes of death in Australia and around the world. As part of this position, he has overseen a major building initiative to unite SAHMRI's various research efforts currently conducted in numerous locations.
Prior to joining SAHMRI, he served as Medical Director of Intravascular Ultrasound and Angiography Core Laboratories at the Cleveland Clinic and Clinical Director of the Cleveland Clinic Center for Cardiovascular Diagnostics and Prevention. Dr. Nicholls was also Associate Director of the Cleveland Clinic Coordinating Center for Clinical Research and Assistant Professor of Molecular Medicine at the Cleveland Clinic Lerner College of Medicine at Case Western Reserve University. He held dual faculty appointments in the Robert and Suzanne Tomsich Department of Cardiovascular Medicine in the Sydell and Arnold Miller Family Heart & Vascular Institute at Cleveland Clinic, and the Department of Cell Biology in the Learner Research Institute.
His clinical trial expertise includes investigating the impact of novel anti-atherosclerotic therapies and serving as the principal investigator of the SATURN (high dose statins for evaluating plaque regression), AQUARIUS (renin inhibition), ASSERT (apoA-I induction) and ASSURE (apoA-I induction), and ACCELERATE (CETP inhibition) studies; study chair of VISTA-16 (sPLA2 inhibition); and member of the steering committees of the DalOutcomes (CETP inhibition) and ALECARDIO (PPAR a/g agonist) studies. He has also authored more than 400 original manuscripts, meeting abstracts, and book chapters.
Dr. Nicholls received his medical degree from the University of Adelaide in Australia. He is a fellow of the Royal Australasian College of Physicians and American College of Cardiology and a member of the American Heart Association. He received the Helen May Davies Research Award from the National Heart Foundation of Australia, the Young Investigator Award at the 13th International Symposium on Atherosclerosis, and was a finalist for the Samuel A. Levine Clinical Young Investigator Award at the 2005 Annual Scientific Sessions of the American Heart Association.
Today we released updated research on AtheroNova Inc. (AHRO-OTC), a biotechnology company focused on the development of compounds to safely regress atherosclerotic plaque and improve patients’ lipid profiles. Our latest 12-page Quarterly Update on AtheroNova discusses the Company’s financial results for its 2012 fiscal year as well as its continued progress in the development of therapeutic clinical-stage product candidates.
AtheroNova’s most advanced candidate, AHRO-001, works to reduce the incidence and severity of atherosclerotic plaque by employing a bile salt to dissolve existing plaque deposits as well as prevent new deposits from forming. AtheroNova plans to develop its patent-pending technology in multiple applications, including cardiovascular disease, stroke, PAD, dementia/Alzheimer’s, and erectile dysfunction—all of which have been linked to atherosclerosis.
The global lipid regulator market was valued at $38.7 billion in revenues in 2011, driven by a high prevalence of cardiovascular disease and limited therapeutic options (Source: IMS Health). Today, despite concerns over long-term tolerability, safety, and efficacy, statins are still considered the most effective method available for reducing cholesterol levels--indicating a serious unmet clinical need for better plaque-fighting products. Moreover, new research has found that the use of statins may actually result in an increase of certain types of coronary plaque. AtheroNova believes that its ability to potentially regress atherosclerosis, coupled with a favorable safety and tolerance profile for its compounds, provides a competitive advantage against currently approved therapies including statins, which merely stabilize the disease.
Highlights from the April 2013 Quarterly Update include the following:
AtheroNova expects to initiate and complete a Phase I trial for AHRO-001 in Russia by the third quarter 2013. The Company has secured financing to fund Phase I and Phase II clinical trials in Russia, and has already filed an Investigational New Drug (IND) application for AHRO-001 with Russia’s Ministry of Healthcare through its licensing and development partner, OOO CardioNova. AtheroNova intends to file a U.S. IND application in 2013 for AHRO-001.
Preclinical U.S. studies for AHRO-001 at UCLA and Cedars-Sinai demonstrated that use of the compound resulted in plaque and cholesterol reduction. The use of AHRO-001 has been found to lead to a 95% reduction in innominate arterial plaque formation versus a control group. In addition, the compound was well tolerated at high doses, and did not show morbidity, adverse effects, or mortality issues.
In the first quarter 2013, AtheroNova launched a new website designed to keep the public updated on its clinical programs and milestones as it transitions from a preclinical to a clinical-stage company. Furthermore, the Company developed an app that provides investors and users with updated Company news and access to AtheroNova’s public documents.
For additional information about the Company's technology, news announcements, and stock information, as well as to download published research reports, please see AtheroNova's Corporate Profile.
This morning, Crystal Research's CEO Jeff Kraws was invited to participate in a roundtable discussion to analyze how investors should be reacting to President Obama's State of the Union address. The segment was hosted by Thomson Reuters' Rhonda Schaffler and also featured David Joy, Chief Market Strategist of Ameriprise Financial, and Craig Irwin, Senior Vice President at Wedbush Securities.
Mr. Kraws spoke specifically about effects on the healthcare industry, while Wedbush's Irwin and Ameriprise's Joy covered energy, cleantech, and technology impacts.
Kraws' key takeaway was to look to innovators in the healthcare industry for future value, chiefly those companies that are trimming costs and becoming more efficient in order to invest more heavily in their R&D. These companies seek to create future growth, and are in line with objectives for reducing overall healthcare costs by providing the medicines and products that keep people healthier. His recommendations range from stalwart drugmakers like Pfizer and Bristol-Myers to smaller, innovative firms like Unilife or MetaStat and generic manufacturers like Teva.
In the energy and cleantech sectors, innovation will also be key going forward. Irwin described several stocks to look at for value in these sectors, including Bridgelux, Cree, and Johnson Controls. Each of these firms--in addition to 60 other growing companies--is profiled in our December 2012 report, Nanotechnology and the Built Environment: Investing in Green Infrastructure. The report offers a detailed look at the U.S. infrastructure industry and how developments from advanced lighting technologies and deployment of a smart power grid to 3D printing are changing the face of our built environment and creating new investment opportunities.
View the entire Reuters' segment below (~25 minutes):
Crystal Research Associates has released a Quarterly Update on AtheroNova Inc., a biotechnology company focused on the research and development of compounds that safely regress atherosclerotic plaque and improve patients’ lipid profiles. The 12-page report is available here.
Atherosclerotic plaque is a buildup of fat, cholesterol, and other substances. These plaque deposits, which progressively narrow and block the arteries, are the main underlying cause of cardiovascular disease, including heart attack, stroke, and peripheral artery disease (PAD).
Driven by a high prevalence of cardiovascular disease and limited therapeutic options, the global lipid regulator market reached $38.7 billion in revenues in 2011 (Source: IMS Health). Currently, lipid regulators, specifically statins, are the most effective method available for reducing serum cholesterol levels. At commonly prescribed dosages, however, they are not effective at significantly reducing atherosclerotic plaques, have drawbacks with tolerability, and may pose complications with long-term use.
AtheroNova plans to develop its patent-pending technology in multiple applications, including cardiovascular disease, stroke, PAD, dementia/Alzheimer’s, and erectile dysfunction—all of which have been linked to atherosclerosis.
AtheroNova's Lead Candidate Is Poised to Enter Phase I Human Clinical Trials
The Company’s most advanced candidate, AHRO-001, works to significantly reduce the incidence and severity of plaque by employing a bile salt to dissolve existing plaque deposits as well as prevent new deposits from forming. Bile salts are an FDA-approved natural compound used to dissolve gallstones.
In preclinical studies at UCLA and Cedars-Sinai to date, use of AHRO-001 has led to a 95% reduction in innominate arterial plaque formation versus the control group. The compound has not shown morbidity, adverse effects, or mortality, and was well tolerated at high doses.
AHRO-001 is progressing toward Phase I human clinical trials in Russia with the support of AtheroNova’s research and development partner, Russia-based OOO CardioNova, Ltd. OOO CardioNova has filed an Investigational New Drug (IND) application for AHRO-001 with Russia’s Ministry of Healthcare. Pending regulatory approval, AtheroNova anticipates that Phase I trials could be completed in 2013, followed by a Phase II clinical study. OOO CardioNova’s parent company, the Maxwell Biotech Group, has agreed to fund Phase I and Phase II clinical trials in Russia. The Company also plans to file an IND in the U.S. during 2013.
Establishing an Intellectual Property Portfolio for Lipid Modulation and Reduction
AtheroNova is focused on developing a comprehensive intellectual property portfolio to protect its lipid modulation and reduction technologies going forward, including for various compounds and administration techniques for treating atherosclerosis. In November 2012, AtheroNova achieved its first major step toward this goal with the receipt of a Notice of Issuance for its patent application #12/024,908, entitled “Dissolution of Arterial Plaque” (now U.S. Patent No. 8,304,383). This patent protects the Company’s lead candidate, AHRO-001, and aims to cover the use of hyodeoxycholic acid for atherosclerotic plaque lesions. AtheroNova’s partner, OOO CardioNova, submitted a similar filing on the Company’s behalf in the Eurasian markets.
AtheroNova Continues to Strengthen its Leadership
In recent months, AtheroNova has focused on expanding and strengthening its leadership team as the Company seeks approval for and prepares to initiate clinical trials. In particular, AtheroNova has appointed Mark K. Wedel, M.D., J.D. as its senior vice president of clinical affairs and chief medical officer. Dr. Wedel has expertise in the development and clinical affairs of lipid-modulating drugs. As well, the Company has selected Joan E. Shaw, MT (ASCP) (medical technologist, certified by the American Society for Clinical Pathology) as senior director of clinical operations. Ms. Shaw brings extensive clinical operations experience, including for AstraZeneca’s ASTEROID trial for the statin Crestor®. AtheroNova also expanded its Board of Directors with the addition of Mr. Fred Knoll, the principal and portfolio manager of Knoll Capital Management. Biographies for these individuals are provided on pages 7-8 of AtheroNova's Quarterly Update.
For additional information about the Company's technology, news announcements, and stock information, as well as to download published research reports, please see AtheroNova's Corporate Profile.