Ampliphi Biosciences Corp (OTCMKTS:APHB) is making a highly explosive move up on big volume in recent days. The stock has been upward bound since hitting an all-time low of $0.07 back in October of last year.
Everyone loves these ex big board stocks for their ability to trade big volume and make huge moves once on the bb’s. APHB traded on the NASDAQ until February 21, 2010 and according to management is going to make a run to be re listed to a bigger exchange.
Ampliphi Biosciences Corp (OTCMKTS:APHB) is a biotechnology company focused on the development and commercialization of novel bacteriophage-based antibacterial therapeutics. The Company’s product development programs target infections that are often resistant to existing antibiotic treatments.
APHB is collaborating with a number of leading organizations, including Intrexon Corporation, the U.S. Army, The Royal Brompton Clinic in London, UK and UK-based University of Leicester, to rapidly advance bacteriophage-based therapies.
Ampliphi Pipeline overview:
AmpliPhage-001 – AmpliPhi is developing its Pseudomonas program with the Royal Brompton Hospital, UK. During 2014, AmpliPhi further characterized its bacteriophage product candidate selection to target gram negative Pseudomonas aeruginosa in mild to moderate cystic fibrosis and successfully conducted a meeting earlier this year with the Medicines and Healthcare Products Regulatory Agency. In 2015, AmpliPhi expects to conduct preclinical animal work including a GLP inhalation toxicology study to support an early Phase I/II study in mild to moderate cystic fibrosis. AmpliPhi is currently evaluating a number of nebulizers to identify an appropriate candidate for administration of its phage mixture to the lungs.
AmpliPhage-002 – Throughout 2014, AmpliPhi worked with the USARMRMC and certain groups within, namely the Walter Reed Army Institute of Research, in order to further develop AmpliPhage-002, to target multi-drug resistant Staph aureus, including MRSA and vancomycin resistant Staph aureus.
AmpliPhi has already produced its first batches of bacteriophage in its dedicated facility in Slovenia, commissioned during 2014. The facility is currently awaiting final GMP certification following an initial GMP audit in late 2014. The facility has been reviewed by the US Army, a former FDA inspector and EU regulatory authorities. Under all inspections and audits, including the formal regulatory audit for GMP inspection, the facility did not receive any notices of findings which are expected to delay GMP certification.
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AmpliPhi is conducting several preclinical studies and validation studies, which will be completed in early 2015, to ensure proposals to enter human clinical trials are fully supported and validated. On the basis of successful results, AmpliPhi anticipates starting a proof-of-concept nasal decolonization clinical trial at the Walter Reed Institute of Research in the second half of 2015. AmpliPhi may instead also proceed with a more direct approach to better support the Army’s primary interest in wound infections and a streamlined regulatory pathway with a Phase I study to directly pursue topical and wound infections.
AmpliPhage-004 – AmpliPhi and University of Leicester are developing a panel of C. difficile bacteriophages as a targeted treatment against C. difficile infection. During 2014, the teams demonstrated the highly lytic capability of these bacteriophage. University of Leicester reports the phage are able to kill 86% of clinically relevant ribotypes including RT014/020 and RT027, two of the most prevalent and virulent ribotypes of C. difficile. This work and additional work in nonclinical models of C. difficile infection will be published in 2015.
During 2015, AmpliPhi and University of Leicester will continue nonclinical product optimization including phage and host production optimization, formulation development and finalization, and potential combination therapies with antibiotics. These efforts will prepare the product for entry into human clinical studies in 2016.
On March 10 APHB announced that it has entered into definitive purchase agreements of common stock and warrants with a group of institutional accredited investors, including both existing and new investors, as well as with its strategic alliance partner Intrexon to raise approximately $13,000,000 in a private placement financing.
Pursuant to the purchase agreements, the Company will issue an aggregate of 78,787,880 shares of the Company’s common stock at a price per share of $0.165, as well as the sale and issuance of warrants to purchase 0.25 shares of common stock for each share of common stock per warrant share. The warrants, which represent the right to purchase an aggregate of 19,696,971 shares of common stock, expire in March 2020 and will be exercisable at a price of $0.215 per share.
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Currently trading at an $83 million market valuation APHB has a strong cash position of $9.8 million, no revenue to date and manageable debt. APHB is an exciting story developing in small caps; the Company has science on its side, an eye on a bigger exchange and a loyal shareholder base that believes this one goes much higher. We will be updating on APFB when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with APFB.
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Disclosure: we hold no position in APHB either long or short and we have not been compensated for this article