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This Month's Tiny Gems - January 2014
Actinium Pharmaceuticals, Inc. (ATNM)
CytRx Corp. (NASDAQ:CYTR)
ForceField Energy, Inc. (NASDAQ:FNRG)
Methes Energies International Ltd. (NASDAQ:MEIL)
VolitionRx Ltd. (VNRX)
Actinium Pharmaceuticals, Inc. (ATNM)
Actinium Pharmaceuticals, Inc. (ATNM) is a biopharmaceutical company with a proprietary platform that combines the precision targeting of monoclonal antibodies with the killing power of alpha and beta radioisotopes, the former being the most potent cancer killing agents in existence. Leveraging this platform and its ties with leading cancer institutions such as Sloan-Kettering (its largest shareholder), MD Anderson, Fred Hutchison, and Johns Hopkins, the company is focused on developing drugs for underserved cancers with no approved drugs which have multi-billion dollar market potential.
Iomab-B, Actinium's lead product candidate, targets age 55+ patients who suffer from one of the deadliest of blood cancers called Acute Myeloid Leukemia (AML). There are no approved drugs for AML patients and most die within six months. For the few that do manage to go into remission, a bone marrow transplant offers a chance at being cured. However, even this is a risky procedure for these patients and most do not survive beyond six months. But in a Phase 2 trial, one in five patients who received Iomab-B before a bone marrow transplant made it past the two year anniversary when they are considered cured versus almost zero for those who do not. These results imply such a medical breakthrough that the FDA has agreed that the company may conduct just one pivotal trial before filing for BLA approval, assuming it is successful. The primary endpoint in the pivotal Phase 3 trial is durable complete remission, defined as a complete remission lasting 6 months. The Phase 1/2 trial results showed that sixty percent of older patients with advanced refractory and relapsed leukemia achieved disease fee survival after six months.
Iomab-B has shown in many cancers during several Phase 1 and 2 trials with over 300 patients that its use can meaningfully increase survival of bone marrow transplant patients, and the company is initially developing it for AML because it is the fastest path to market. The leading experts in the transplant community recognize that Iomab-B has the potential to meaningfully increase the success rate of bone marrow transplants and offer patients who are condemned to die a chance of being cured. As bone marrow transplants are already the fastest growing hospital procedure and a multi-billion dollar market despite their high failure rate, this bodes well for Iomab-B. Also, bone marrow transplants are delivered in under two hundred centers in the U.S. with most transplants being done in just twenty centers. This implies Actinium can commercialize Iomab-B on its own in the US without a major salesforce; especially as it has the support of leading experts and there are no approved drugs for this purpose.
However, Actinium is no one trick pony. It has another drug called Actimab-A for first line treatment of AML in a Phase 1/2 trial. Over time, the biggest market potential for Actinium lies in the fact that its highly patented platform technology could be used to target a wide variety of cancers. Preclinical and clinical work has already focused on Non-Hodgkin Lymphoma (NHL), brain cancer, bladder cancer, ovarian cancer, breast cancer, prostate cancer, and a number of other cancer related indications. Aside from Iomab-B, the company plans to develop its products through Phase II clinical trials and then partner with an appropriate third party to complete development and commercialization. The compelling advantages of the Actinium's platform should continue to draw attention from the healthcare and investor communities. A closer look at their technology will further illustrate the immense licensing and acquisition potential inherent in the company's high-momentum product pipeline. In fact its closest technology competitor, Algeta, which is about 3-4 years ahead from a market perspective, was just acquired by Bayer for $2.9 billion.
CytRx Corp. (NASDAQ:CYTR)
CytRx Corp. (CYTR), a biopharmaceutical research and development company, specializes in the enhanced delivery of proven oncology therapies to treat cancer. The company’s novel linker platform technology can be utilized with multiple chemotherapeutic agents and could allow for greater concentration of drug at tumor sites while minimizing side effects.
Aldoxorubicin, the company’s flagship compound, is an improved version of the widely used chemotherapeutic agent doxorubicin. CytRx is conducting a global Phase 2b clinical trial comparing aldoxorubicin to doxorubicin as a treatment for 1st-line soft tissue sarcomas. Top-line results are expected in Q4 2013. Preparations are underway for a Phase 3 trial in 2nd-line soft tissues sarcoma to begin in Q1 2014 based on results from a completed Phase 1b/2 clinical trial. The FDA granted CytRx a Special Protocol Assessment (SPA) for the Phase 3 clinical trial. The company is conducting a Phase 1b pharmacokinetics clinical trial and in Q4 2013 plans to start a Phase 2b trial in glioblastoma multiforme (stage IV brain cancer) and a Phase 2 trial in Kaposi’s sarcoma.
With no debt and significant cash resources, CytRx has the capital position necessary to support near and mid-term milestones across its entire oncology pipeline. CytRx also has rights to two additional drug candidates, tamibarotene and bafetinib, for which it plans to seek a partner for further development.
Collectively, CytRx's management and Board of Directors have significant oncology experience and have brought numerous oncology drugs to market. Daniel Levitt, M.D., Ph.D., EVP and Chief Medical Officer, served as President of R&D at Protein Design Labs, as head of oncology drug development at Sandoz Pharmaceuticals, as director of clinical oncology at Hoffmann-LaRoche, and was instrumental in the development of five approved cancer drugs. Joseph Rubinfeld, Ph.D., a director since July 2002 is a renowned expert in the field of oncology, was one of the four initial founders of Amgen, Inc. and was a founder of SuperGen, Inc. Max Link, Ph.D., Chairman of the Company's Board of Directors since 1996, was a former Chairman and CEO of Sandoz Pharma (now Novartis) and is currently the Chairman of the Board of Alexion Pharmaceuticals.
ForceField Energy, Inc. (NASDAQ:FNRG)
ForceField Energy, Inc. (NASDAQ:FNRG) is an international manufacturer, distributor, and licensee of alternative energy products and solutions. ForceField has two primary segments through which it focuses on the largest and fastest-growing areas of the global renewable energy market: industrial waste heat recovery and conversion, and commercial LED lighting products.
TransPacific Energy (TPE), a subsidiary of ForceField Energy, has patented a technology that uses “waste heat” from various industry processes and other sources to provide clean electricity. The subsidiary’s process directly captures and converts heat from the heat source, without any heat transfer fluids, at temperatures from 80ºF up to 900ºF. This is a far broader range than any other competing systems on the market, unlocking a countless number of new applications.
TPE sells systems directly to customers for their installation and operation. The company owns, installs and operates ORC systems, sells electricity, licenses its technology for specific applications and markets and conducts research and development for new ORC applications and renewable energy.
Through its exclusive multinational distribution agreement with Lightsky, ForceField has a firm foothold in the commercial lighting products industry as well. The LED lighting market is growing at a 32% compound growth rate because of the absence of dangerous chemicals, government regulation phasing out old lighting technology, 50-70% lower energy costs, exceptionally long life, and beautiful illumination.
Methes Energies International Ltd. (NASDAQ:MEIL)
Methes Energies (MEIL) uses its own proprietary technology to produce high-quality biodiesel processors and systems to capitalize on the growing demand for renewable energy, surging energy prices, and the value of biodiesel as a practical and realistic long-term replacement for conventional diesel fuel. The Company’s processors are flexible and can use a variety of virgin vegetable oils, used vegetable oil and rendered animal fat feedstock, allowing operators to take advantage of feedstock buying opportunities. Methes Energies also markets and sells high-quality biodiesel fuel produced at its 1.3 MGY (5 MLY) showcase production facility in Mississauga, Ontario, and at it’s 13 MGY (50 MLY) facility in Sombra, Ontario, to customers in the U.S. and Canada.
Methes Energies’ broad range of expertise and solutions include all aspects of the engineering, manufacturing, production, logistic, marketing and distribution processes. Among other services, the company leverages its cutting-edge biodiesel processors, pre-treatment systems, and other solutions to address real and specific biodiesel production challenges for large and small-scale biodiesel producers and entrepreneurs seeking to produce their own fuel.
In 2007 the company introduced the Denami 600, the industry’s first compact, full automated continuous flow biodiesel processor designed to run on a wide variety of feed stocks. This reliable, cost-effective and superior method of producing top-grade biodiesel exceeds current ASTM standards.
The company also sells feedstock to its network of biodiesel producers, selling their biodiesel production and providing clients with proprietary software to operate and control their processors. Methes Energies remotely monitors the quality and characteristics of its clients' production, upgrades and repairs their processors as necessary, and advises clients on adjusting their processes to use varying feedstock to improve the quality of their biodiesel.
As a competitive and highly respected revenue-generating player in the North American biodiesel sector, Methes Energies is fast building a network of biodiesel operators and facilities to capitalize on buying power and economies of scale. The North American demand for biodiesel is sizeable and the company is well positioned for global expansion throughout Europe, South America, Africa and Asia.
VolitionRx Ltd. (VNRX)
VolitionRx Ltd. (VNRX) is a life sciences company focused on bringing to market its inexpensive, accurate, and scalable cancer detection blood tests. The company intends to use its NuQR suite of products to fill a looming void in cancer diagnostic testing, for which there currently is only one blood test in common clinical use.
NuQR is based on VolitionRx's proprietary NucleosomicsR technology, capable of measuring and identifying nucleosome structures in the blood. The company has secured strong intellectual property protection for its products, further strengthened by patent applications in the United States, Europe and worldwide. Following ongoing clinical trials and regulatory approval, VolitionRx will market its diagnostic and screening tests for individual cancers under the NuQR brand.
The company is currently conducting clinical trials for its first product, a diagnostic test for colorectal cancer. Colorectal cancer is the third most common cancer in the United States - current tests are expensive, invasive and unpleasant, resulting in a significant need for an improved alternative for colorectal diagnoses.
VolitionRx's primary office and laboratory are based in Namur, Belgium, from which the company's strong team of professionals spearhead corporate initiatives. The company's executive management team is further supported by a scientific advisory board staffed with senior scientists from around the world, as well as a highly experienced board of directors.