Sign Up NowThis Month's Tiny Gems - October 2013

Boston Therapeutics, Inc. (BTHE)
Calpian, Inc. (CLPI)
CytRx Corp. (NASDAQ:CYTR)
Galena Biopharma, Inc. (NASDAQ:GALE)

 

 

 

Boston Therapeutics, Inc. (BTHE)

 

Boston Therapeutics, Inc. (BTHE) is a pharmaceutical company focused on the development and commercialization of novel compounds based on complex carbohydrate chemistry to address unmet medical needs. An IP portfolio solidifies the company's position in the pharmaceutical industry. Boston Therapeutics' current product pipeline, PAZ320 and IPOXYNT, is comprised of therapies developed to treat patient populations with Type 2 diabetes.

 

PAZ320 is a non-systemic, non-toxic, chewable drug candidate for prevention of diabetes and its complications. PAZ320 inhibits the enzymes that release glucose from complex carbohydrate in foods during digestion. Boston Therapeutics believes PAZ320 is a safe and effective drug compound for people with pre-diabetes and diabetes in their daily management of blood glucose levels, fulfilling an unmet medical need. PAZ320 has completed a Phase ll clinical trial at Dartmouth Medical Center. 45% of the patients responded with a 40% reduction in the elevation of post meal blood sugar compared to baseline with no serious adverse events.

 

IPOXYN, a universal oxygen carrier, is an injectable Rx for prevention of necrosis and treatment of ischemic conditions which may lead to necrosis. This compound is not a biologic, but a second generation New Chemical Entity HBOC (hemoglobin based oxygen carrier). The potential for this product goes well beyond Lower Limb Ischemia into a range of areas from anemia and blood loss (injury), to cardiovascular disease and surgical blood supplementation.

 

The Boston Therapeutics management and advisory team has extensive expertise in complex carbohydrate chemistry, regulatory affairs, and clinical development, with multiple submissions and approvals to U.S. Food and Drug Administration. Backed by a team with more than five decades of expertise in public and private business management, the company is well positioned to advance its status as a premier developer of complex carbohydrate-based new chemical entities.

 

 

 

Calpian, Inc. (CLPI)

 

Calpian, Inc. (NASDAQ:CLPI) has forged a powerful combination of steady cash flow here in the U.S. on the one hand, and explosive growth potential abroad in India on the other. Both business units are growing fast and creating huge value that has so far gone largely overlooked due to the company’s rapid rise.

 

Calpian is a leader in the U.S. business for providing access to credit and debit card payment processors for merchants and also for making investments in the resulting cash flow streams. Calpian's management team, with over 60 years of combined experience in payments, has also tapped into a super-hot growth opportunity in India where it is the leader in consumer payments using the cell phone - the most powerful financial trend in the developing world today. The company's revenues in India grew 300% year to year and are headed for triple digit growth again in 2013. Examples of this service in other countries like Kenya show that consumers need this simple payment tool and adopt it quickly. In Kenya, over 90% of the adult population has adopted a mobile phone money transfer system known as M-PESA, which produces over $100 million pretax profit after only 7 years in business. Calpian is providing this same service in India via Money on Mobile (MoM). India is a market at least 30 times larger than Kenya with vast potential. Calpian is the undisputed market leader in the space and looks poised to dominate the largest market for this service in the world with almost 1 billion cell phones.

 

In the U.S., the company has carved out a solid niche in the growing $1B plus annual residuals space for credit card usage by providing a silver bullet solution including their own gateway that merchants use to connect with large payment processors. Calpian is providing its merchant services through its wholly owned subsidiary, Calpian Commerce, who continues to sign merchants to card processing contracts, while Calpian itself continues acquiring additional recurring monthly cash flows from the over 10,000 smaller Independent Sales Organizations (dealers) throughout the U.S. The management team has been together for decades refining this business model through over 200 acquisitions in their careers before making it public in 2010. The team is experienced and well known throughout the industry as the go-to guys for making a deal.

 

In India, with Calpian acquiring an interest in March 2012 in Digital Payments Processing Limited (DPPL), which delivers the payment processing service for the Money on Mobile solution, it has taken off with incredible force, signing an incredible 53 million consumers though its vast network of 143,000 retailers (and growing at least 3,000 per month) so far. This astonishing growth is thanks in large part to how elegantly the company's mobile payment application, which is already seen as the “PayPal” of India, satisfies all the needs of the average Indian consumer, distributor, and retailer alike. The vast swathes of under-banked and unbanked consumers in India represent the tip of a much larger global iceberg for this solution as well, a solution whose backbone is simple SMS text protocol, and which bundles all the right incentives together for emerging markets. MoM is the runaway leader at this time in India pacing at 20 times larger than its nearest competitor.

 

 

 

CytRx Corp. (NASDAQ:CYTR)

 

CytRx Corp. (NASDAQ: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.

 

 

 

Galena Biopharma, Inc. (NASDAQ:GALE)

 

Galena Biopharma, Inc. (NASDAQ:GALE) is focused on developing and commercializing targeted oncology treatments to address major unmet medical needs and advance cancer care. The company’s peptide vaccine immunotherapies harness the patient’s own immune system to identify and destroy cancer cells. Utilizing peptide immunogens has many clinical advantages, including an excellent safety profile and long-lasting protection through immune system activation and convenient delivery.

 

Abstral® is Galena’s FDA-approved therapy for breakthrough cancer pain in opioid-tolerant cancer patients. It is estimated that at least 40% of cancer patients experience breakthrough pain episodes multiple times per day, each with a median duration of 30 minutes. The innovative Abstral formulation rapidly dissolves under the tongue in seconds, provides rapid relief of breakthrough pain in minutes, and matches the duration of the entire pain episode.

 

NeuVax™, currently in a Phase III trial, has been developed to bolster the immune response in breast cancer patients. The trial, entitled PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment), is being conducted under an FDA-approved Special Protocol Assessment (SPA). The therapy targets the 50% to 60% of patients with tumors that express HER2 in low-to-intermediate amounts and achieve remission with current standard of care, but who have no available HER2 targeted adjuvant treatment options to maintain their disease-free status. NeuVax can be used to help the body target and kill undetected cancer cells before they grow into metastatic tumors.

 

The company’s second product candidate, Folate Binding Protein (FBP), is a highly immunogenic peptide that can stimulate the immune system to recognize and destroy preclinical FBP-expressing cancer cells. FBP is over-expressed in more than 90% of ovarian and endometrial cancers, as well as 20%-50% of breast, lung, colorectal, and renal cell carcinomas. This vaccine is currently in a Phase 1/2 trial in two gynecological cancers: ovarian and endometrial adenocarcinomas.

Galena’s experienced management team has an excellent track record in clinical development, commercial operations, and successful partnership execution. Enhanced by multiple development and commercial collaborations, the company’s suite of immunotherapeutic solutions is poised to capitalize on the vast opportunities in today’s healthcare industry.

 

Note: Abstral carries a Black Box warning. Please refer to the full Prescribing Information for further information.