Frequently Asked Questions about Protagenic Therapeutics, Inc.
WHAT IS PROTAGENIC THERAPEUTICS AND WHAT IS IT TRYING TO ACCOMPLISH?
Protagenic Therapeutics (OTCQB: PTIX) is a pre-clinical biopharmaceutical company endeavoring to develop first-in-class neuro-active peptides into human therapeutics to treat anxiety, treatment-resistant depression, and other disorders. In 2016, the company completed a reverse merger and a private financing, secured working capital to pursue its development goals through an expected filing of an IND application with the FDA. The company’s R&D team is carrying out the necessary steps to accomplish these critical tasks and to refine and enhance our science platform. We have accumulated a strong intellectual property estate and will strategically add to our IP portfolio over time. We appreciate the investor enthusiasm demonstrated with our successful financing, and we are motivated by our progress to date and for the potential of our novel lead compound to change the way mood disorders are treated.
DOES PROTAGENIC THERAPEUTICS HAVE THE RESOURCES IT NEEDS TO ACHIEVE ITS GOALS?
Protagenic Therapeutics, previously Atrinsic, completed $5.1 million private placement in April 2016, and has begun to deploy this capital in independent preclinical tests of its lead compound. The drug candidate, PT00114, has shown encouraging early results as a therapeutic agent to treat depression and/or anxiety.
HOW MUCH OF THE CAPITAL PROTAGENIC THERAPEUTICS RAISED THIS YEAR WAS USED TO REPAY DEBT?
The company conducted a private placement in three closings from February 12 through April 15, 2016, which yielded net cash proceeds of $4,283,437.50. All of the cash proceeds are being used to fund working capital. In conjunction with private placement, the company converted approximately $500,000 in previously accumulated debt into equity.
WHAT IS THE EVIDENCE THAT PROTAGENIC THERAPEUTICS’ MAIN DRUG CANDIDATE MAY BE EFFECTIVE?
Our studies have shown evidence that PT00114 is a strong regulator of cellular metabolism, including neuronal cells. Because this mechanism is similar across different animal species and humans, we believe that our experimental observations can form the basis for our molecule to work by profoundly improving neuronal health. Such a regulation of energy metabolism in the brain can form the impetus for us to target depression, anxiety, addictive disorders, as well as post-traumatic stress disorder (PTSD) as a potential first set of disease indications. In July 2016, we obtained additional data that suggests PT00114 may have long-term benefits in major depression using mouse models.
HOW MANY SHARES OF STOCK DID THE COMPANY ISSUE IN ITS FINANCING IN SPRING 2016, AND AT WHAT PRICE?
We sold 4,108,460 Series B Preferred shares at $1.25 per share.
WHAT ARE THE COMPONENTS OF PROTAGENIC THERAPEUTICS’ CAPITAL STRUCTURE?
As of January 26, 2017, after giving effect to the Merger Transaction and the Reverse Split, our issued and outstanding securities are as follows:
• 10,261,419 shares of common stock;
• 872,766 shares of Series B Preferred Stock;
• Options to purchase 1,807,744 shares of common stock at an average exercise price of approximately $1.05 per share;
• Options to purchase 1,351,083 shares of common stock at an exercise price of $1.25 per share;
• Warrants to purchase 423,291 shares of common stock at an exercise price of $1.25 per share; and
• Warrants to purchase 3,403,367 shares of common stock at an average exercise price of approximately $1.05 per share per share.
IN WHAT CLASS OF DRUGS DOES PT00114 BELONG?
Over the past few years, experimental results have indicated that PT00114 appears to work by a mechanism not seen in commercially-available drugs today. A better understanding of PT00114’s mechanism of action has helped us with the interpretation and design of preclinical experiments. We believe our lead compound is potentially a ‘first-in-class’ drug.
HOW LONG UNTIL PROTAGENIC THERAPEUTICS CAN REACH DEFINED MILESTONES IN THE DEVELOPMENT OF PT00114?
Protagenic Therapeutics is committed to advancing its biological expertise to help build a strong presence with novel, first-in-class approaches in the treatment of a variety of psychological and psychiatric diseases. We believe that understanding the biology of disease as well as the mechanism of action of a potential intervention will help facilitate more efficient and speedy clinical development while improving the probabilities of success in clinical trials. We expect our IND-enabling studies to be completed by March 2018, followed by IND submission to the FDA in the 2nd quarter of 2018. If this IND is accepted by the FDA, we anticipate being able to commence Phase I clinical trials in 2018.