Friday, December 16, 2016

PharmaCyte Biotech, Inc. (PMCB) Pre-IND Meeting with FDA Makes ATM Funding Possible

For California-based PharmaCyte Biotech, Inc. (OTCQB: PMCB), a light at the end of the pipeline tunnel has become visible as one piece of good news follows another. The approval by the FDA to entertain a Pre-Investigational New Drug (Pre-IND) submission from the company sent PMCB stock soaring to triple its pre-approval value. The resulting market cap made PharmaCyte ‘primarily eligible’ to register securities for sale in an at-the-market (ATM) offering, which it now plans to do through Chardan Capital.

To make an ATM offering requires that the issuer be eligible, on a primary basis, to use a shelf registration statement on Form S-3. The Form S-3 filing initiates an equity distribution program under which, from time to time, ATM offerings can be made. Each ATM offering is a drawdown from the related shelf registration securities offering.

ATM offerings have a number of advantages. They typically cost less than traditional follow-on offerings, particularly since they are executed without high profile, expensive road shows. They also give an issuer the flexibility to determine the timing and size of any share sale, while allowing shares to ‘trickle’ into the market in a way that does not adversely affect the stock price.

PharmaCyte is now primarily eligible to use Form S-3 to offer securities, on its own behalf, for cash on an unlimited basis in ATM offerings, since the aggregate market value of its voting and non-voting common equity held by non-affiliates (i.e., the public float) is at least $75 million. The company intends to use funds received from the ATM offerings to advance the clinical trial process of its signature live-cell encapsulation technology, Cell-in-a-Box®.

PharmaCyte will be submitting a full Pre-IND package of information to the FDA that will set out essential elements of its planned Investigational New Drug (IND) application. After which, the FDA will review PharmaCyte’s manufacturing, preclinical pharmacology and toxicology, and clinical trial plans for the company’s therapy to treat locally advanced pancreatic cancer (LAPC). On successful completion of the review, PharmaCyte will be able to proceed with enrolment of the first clinical trial.

PharmaCyte’s clinical trial for LAPC is designed to meet a clear unmet medical need for those whose cancer no longer responds after 4-6 months of treatment with the combination of Abraxane® and gemcitabine. The trial will be open-label and multi-site in nature, with sites in the U.S. and Europe. Patients with LAPC will be randomized equally into two groups. One group will receive gemcitabine chemotherapy alone, and the other will receive PharmaCyte’s pancreatic cancer therapy. In addition to comparing the anticancer activity and safety of the two therapies, a major aspect of the trial will be to determine if, and how well, PharmaCyte’s therapy can shrink inoperable tumors so that they may become operable.

To work on its novel technology, Cell-in-a-Box®, PharmaCyte has assembled a respected team of oncologists that includes leading pancreatic cancer expert Dr. Daniel Von Hoff from Translational Drug Development (TD2), Dr. Manuel Hidalgo from Harvard Medical School, and Dr. Matthias Löhr from the Karolinska Institute in Stockholm, Sweden.

PharmaCyte Biotech is a clinical stage biotechnology company developing therapies for cancer and diabetes based upon a proprietary cellulose-based live cell encapsulation technology known as Cell-in-a-Box®. The Cell-in-a-Box® therapy for cancer involves encapsulating genetically engineered human cells that convert an inactive chemotherapy drug into its active or anti-carcinogenic form.

These encapsulated cells are implanted as close to the patient’s cancerous tumor as possible. Once implanted, a chemotherapy drug that is normally activated in the liver (ifosfamide) is given intravenously at one-third the normal dose. The ifosfamide is carried by the circulatory system to the location of the implanted encapsulated cells.

When the ifosfamide comes in contact with the encapsulated cells, they act as an artificial liver and activate the chemotherapy drug at the source of the cancer. This targeted chemotherapy has proven effective and safe to use in past clinical trials and results in no side effects.

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