Entering a $20 Billion Market

The Biopharmaceutical Company Aiming to Treat Stress-Related Disorders, Without Disrupting Normal Brain Function

Protagenic Therapeutics, Inc. (Nasdaq: PTIX) is a pre-clinical biopharmaceutical company, engaged in the discovery and development of therapeutics to treat stress-related neuropsychiatric and mood disorders. Its lead compound, PT00114, is a synthetic form of an endogenous brain signaling peptide that can dampen overactive stress responses, without impairing normal brain function. Protagenic recently grossed $13.2 million in a follow-on equity offering and uplisting to Nasdaq, giving it the extra capital and increased exposure needed to fund more trials as it moves forward. 

 

Positioned for Success 

Massive Market Potential – The combined market size for treating depression, PTSD, anxiety, addiction, and other stress disorders is roughly $20 billion. That is Protagenic’s target, and it’s going to have its hands full. 59 million Americans suffer from some form of stress disorder or addiction, and many of those ailments are resistant to current treatments. In some cases, the treatment for the disorder results in undesirable side-effects. The potential of a product that serves these populations without side-effects is hard to overstate. 

A Unique Approach – Protagenic’s lead drug candidate, PT00114, is based on a naturally occurring brain peptide called teneurin C-terminal associated peptide (TCAP). There is evidence to support that administered TCAP has potential to restore disordered nerve function in settings, such as depression, where it has been found to be deficient. And it can do that without interfering with normal brain function. 

The IP Edge – Protagenic has been developing its approach for over 14 years, and it has the patents to prove it. Protagenic owns worldwide exclusive rights to commercialize TCAP across six families of commercialization and methods of use patents, as well as additional market exclusivity through PT00114’s regulatory designation as a biologic (12 years in the US, 10 years in EU post-launch).

Potentially Better – Pre-clinical testing suggest the lead drug candidate PT00114 may have key advantages over the current drugs on the market; it may be faster acting, may be longer lasting, could avoid liver toxicity, may be manufactured more cheaply than current medications, and there is no evidence of dependency in animal studies.

 

Cutting Edge Science, Aiming to Serve Millions in Need

Protagenic Therapeutics, Inc. (Nasdaq: PTIX) is in an enviable position. After a successful follow-on equity offering and uplisting to Nasdaq, it has cash on hand and increased exposure as it enters the next phase of trials for its novel drug candidate PT00114. The best part? Its patented compound is proving to be effective and safe in animal models at treating depression, anxiety, PTSD, addiction, and other stress-related disorders. We think Protagenic is perfectly positioned to serve a market valued at roughly $20 billion. 

 

A Highly Significant Discovery

-From Protagenic’s website –  “An immortalized N38 neuron with the expression of immunoreactive TCAP shown in green fluorescence. This image suggests the role of TCAP in neuronal process development. It shows that the expression of the immunoreactive TCAP occurs around the neuronal periphery — consistent with endoplasmic reticulum and golgi expression, but more importantly associated in regions of neurite growth. This led to understanding the mechanism by which TCAP is thought to regulate inter-neuronal interaction.”

Protagenic is developing novel drugs that are able to treat debilitating ailments, without the side-effects we see in SSRIs and other such medications. Its lead candidate PT00114 acts as a synthetic TCAP in the brain, triggering a natural reduction in stress response. This is an extreme oversimplification, but basically, the drug acts like a “break” for overactive stress hormone responses. And it operates the same way TCAP does naturally, making it safer than other Treatment Resistant Depression (TRD) drugs. 

In animal studies, researchers were able to reproduce dose-dependent reversal of depression, stress-exacerbated anxiety, excessive startle, drug seeking, and opioid withdrawal. These studies also showed both immediate (within three hours of first dose) and long lasting (up to 21 days after a dose) efficacy in pre-treatment and rescue models. Additionally, PT00114 was proven to be incredibly safe. There were no significant adverse effects seen at doses at least 50-fold higher than anticipated human clinical exposures, including no evidence of sedation or dependence. This is ground-breaking stuff! The ability to treat various mental disorders and addiction, without the risk of dependence or withdrawal is massively valuable. We think if Protagenic can market a medication that naturally regulates disorders like depression, minus all the small print about side-effects, it’s sitting on a gold mine. 

Although Protagenic is currently focused on developing treatments for depression, anxiety, PTSD, and addiction, synthetic TCAP has a broad range of potential uses. There is evidence to suggest that it may be useful in treating dementia and alzheimers, and although the research is in early stages, Protagenic could eventually develop an entire pipeline of drugs that treat a variety of disorders. 

 

A Market in Need 

It’s business 101 – find a sizable market with a problem, then solve it. Consider that class aced, because Protagenic is targeting a market worth $20 billion that is actively growing. Depression, anxiety, PTSD, and other stress-related disorders were already on the rise, even before the COVID-19 Pandemic. 

Unfortunately, the forced isolation has caused depression and suicide rates to climb even faster than they would have otherwise, with almost 60 million Americans being effected by some kind of stress-related disorder or addiction. According to Bloomberg, Zoloft prescriptions went up by 12% in March of 2020, just as lockdowns began. The good news is that Protagenic is fighting to get a drug on the market to help the people who need it. 

We think one of the most interesting potential markets is the TRD segment of the population. These are the individuals who can’t get relief, even with medication. There are roughly 12.5 million Americans who’s depression, anxiety, or PTSD doesn’t get better when treated with currently available medication. 

Protagenic’s lead drug candidate shows great promise for the treatment of this particular segment, making it likely to become the de-facto option in those cases. Once clinical trials are completed, we will have a better idea as to the specific efficacy, but for now the animal trials have been encouraging. 

 

Forging Ahead

After successful preclinical trials, PT00114 is set to begin human trials in 2021. From a recent press release,”Dr. Maurizio Fava, Psychiatrist-in-Chief at Massachusetts General Hospital (MGH), and Director of the Division of Clinical Research of the MGH Research Institute, will serve as the principal investigator in its upcoming clinical trial, a Phase 1/2a basket study designed to test PT00114 in healthy volunteers and patients with PTSD, Anxiety and Depression. PT00114 – Protagenic’s lead drug compound – is known scientifically as teneurin C-terminal associated peptide (TCAP), a naturally occurring peptide responsible for regulation of stress response in the brain. PT00114 is a first-in-class compound, and has demonstrated compelling efficacy potential with a strong safety profile in extensive preclinical models.”

Protagenic is on the path to becoming a safer, more effective alternative to current treatments. The team leading the company has consistently hit the milestones they set–and entering human trials is a big one. 

While there is still a ways to go before Protagenic launches a commercial drug, it is moving quickly. Over the next year, it has laid out the key steps for transitioning from a preclinical to a clinical trial company.

 

We are excited about what the future holds for Protagenic Technologies. Results from the Phase I/IIa study will likely lay the foundation for the next several years of development, and the trial’s principal investigator has high hopes, “PT00114 has a unique mechanism of action, with robust effects in preclinical studies. Given the critical role stress plays in Post-Traumatic Stress Disorder, Major Depressive Disorder, and Generalized Anxiety Disorder – coupled with the need to develop new therapeutic options for these patients – it is our hope that PT00114 will emerge as a new medicine for these conditions,” said Dr. Fava. 

 

Parting Thoughts

We think Protagenic has a bright future ahead. Current research indicates that the PT00114 candidate will drastically change the treatment of depression, PTSD, anxiety, addiction, and other stress-related disorders. 

  • Proven Market Need w/ the Potential for Innovation – Protagenic’s approach utilizes the body’s natural stress regulating function to help treat disorders that have a multi-billion dollar market. 
  • Continued Growth – After a successful follow-on equity offer and uplisting, Protagenic has cash on hand, increased visibility, and is ready to enter its next stage. 
  • An Experienced Team – The Protagenic team has multiple decades of experience in biotech and pharma, including; the research, development, and launch of drugs, successful mergers, clinical development and strategy, raising $100 million in funding, and more.

 

Recent Press Releases

 

Management

Garo H. Armen, Ph.D.

Executive Chairman

In addition to his role as Protagenic Therapeutics’ Executive Chairman, Dr. Armen is Chairman and Chief Executive Officer of Agenus Inc., the biotechnology company he co-founded in 1994. From mid-2002 through 2004, he also served as chairman of the board of directors of Elan Corporation, where he successfully engineered the restructuring of the company.

Prior to Agenus Inc., Dr. Armen established Armen Partners, a money management firm specializing in biotechnology and pharmaceutical companies, and was the architect of the widely publicized creation of the Immunex Lederle oncology business in 1993. Earlier, he was a senior vice president of research at Dean Witter Reynolds, having begun his career on Wall Street as an analyst and investment banker at EF Hutton.

In 2002, Dr. Armen founded the Children of Armenia Fund, a nonprofit organization dedicated to significantly rebuilding and revitalizing impoverished rural Armenian towns to provide immediate and sustainable benefits to children and youth. He received the Ellis Island Medal of Honor in 2004 for his humanitarian efforts, and received the Sabin Humanitarian Award from the Sabin Vaccine Institute in 2006 for his achievements in biotechnology and progressing medical research. Dr. Armen was also the Ernst & Young 2002 New York City Biotechnology Entrepreneur of the Year, and received a Wings of Hope Award in 2005 from The Melanoma Research Foundation for his ongoing commitment to the melanoma community. Dr. Armen received a Ph.D. in physical chemistry from the Graduate Center, City University of New York, after which he worked as a research fellow at Brookhaven National Laboratories in Long Island, NY.

 

Andrew Slee, Ph.D.

Chief Operating Officer

Andy Slee has taken several drugs from inception through all their pre-clinical and clinical testing, through commercial launches. During his 36 year pharmaceutical career he has worked with some of the most effective drug development teams. Spreading his influence beyond a single company, he created and ran his own Clinical Research Organization (CRO), VivoSource Laboratories, which for ten years provided preclinical proof of concept catering to biopharmaceutical companies. For the 16 years before that, Mr. Slee shepherded multiple pharma targets from inception onward at DuPont Pharmaceuticals. He is a graduate of Syracuse University.

 

Robert B. Stein, MD, Ph.D.

Chief Medical Officer

In addition to his role as the Chief Medical Officer of Protagenic, Dr. Robert B. Stein is Senior Advisor, R&D for Agenus, Inc. and its cell therapy subsidiary AgenTus. He leads Agenus’ Research, Preclinical Development and Translational Medicine functions. He helps shape clinical development strategy for vaccines and adjuvants. Additionally, he led integration of the 4-Antibody, PhosImmune, and Xoma Pilot Plant acquisitions, which includes the company’s fully human antibody drug discovery and optimization technology platform, and portfolio of immune checkpoint antibody programs. Over his 35 years of experience in the biopharmaceutical industry he played a pivotal role in bringing to the market Sustiva®, Fablyn®, Viviant®, PanRetin®, TargRetin®, Promacta® and Eliquis®. Prior to joining Agenus, he held executive management positions at Ligand Pharmaceuticals, DuPont Merck, Incyte Pharmaceuticals, Roche Palo Alto and KineMed. Dr. Stein began his career at Merck, Sharp and Dohme. He holds an MD and a PhD in Physiology & Pharmacology from Duke University.

 

Alexander K. Arrow, MD, CFA

Chief Financial Officer

In addition to his role as CFO of Protagenic, Dr. Arrow is the CFO of Carlsmed, Inc., a commercial-stage medical technology company leveraging machine learning technologies and prior outcomes data to personalize the treatment of complex adult spinal deformities. He also serves on the Boards of Zelegent, Inc., which sells a minimally-invasive tool for otolaryngologist sleep specialists to treat snoring, and Paragonix Technologies, which manufactures and sells the leading solid organ transport device. He previously served on the Board of Neumedicines, Inc., an immuno-oncology company developing a first-in-class broad-spectrum anti-cancer agent, and was a Director and the President and Chief Operating Officer of Biolase, Inc. (NASDAQ: BIOL), the world’s lead manufacturer of dental lasers, where he also served as Chair of the Audit and Compensation committees of the Board of Directors. Prior to Biolase, Dr. Arrow was the Chief Medical Officer of Stanford-affiliated neuroscience company Circuit Therapeutics, Inc. Prior to that he spent five years as the Chief Financial Officer of cardiovascular device manufacturer Arstasis, Inc. As CFO of Arstasis, he was part of a team that raised over $100 million in five rounds and launched a first-in-class arterial access technology for interventional cardiologists. Before entering medical technology operating roles, Dr. Arrow spent nine years running medical technology equity research at three Wall Street firms, the last five years as the head of medical technology research at Lazard, Ltd. He also served as the Chief Financial Officer of the Patent & License Exchange, Inc. He began his surgical residency at the UCLA Medical Center in 1996 before leaving to go into business. He has an MD from Harvard Medical School and a BA in Biophysics, magna cum laude, from Cornell University.

 

David Lovejoy, Ph.D.

Scientific Founder

A founder of the company from the beginning in September 2004, Dr. Lovejoy holds a Ph.D. in Neuroendocrinology from the University of Victoria (Victoria, BC) and spent three years at the Clayton Foundation Laboratories for Peptide Biology at the Salk Institute (San Diego, CA) as a postdoctoral fellow. Dr. Lovejoy took his first academic appointment at the University of Manchester (Manchester, UK), one of the United Kingdom’s top-ranking research universities. He joined the University of Toronto (Toronto, Ontario) in 2000 and is currently Professor of Neuroendocrinology in the Department of Cell and Systems Biology at the University of Toronto. He is the author of more than 210 scientific publications including 3 books in the field and an Associate Editor for a scientific journal and is inventor or co-inventor on all of our intellectual property.

 

Dalia Barsyte, Ph.D.

Scientific Advisor

Dr. Barsyte received her Ph.D. in molecular and cellular biology from the University of Manchester, UK. Her postdoctoral training at the University of Manchester and Ontario Cancer Institute, Canada focused on characterizing cellular signaling mechanisms. Dr. Barsyte is an inventor of one of the key Protagenic Therapeutics patents and author of over 50 scientific publications in oncology and neuroscience. Dr. Barsyte’s scientific interests include exploring chemical biology in therapeutic target validation through peptide or small molecule chemical probe compounds, as well as novel in vitro models of disease based on patient derived cell culture.

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  • Period of Campaign - 10/15/2020 - 3/15/2021
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  • Name of Issuer & Ticker Symbol - Protagenic (PTIX)
  • Number of Shares We or our Affiliates Hold - 81,967
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  • Date Issued - 9/28/2020

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