Replies to post #304541 on Innovation Pharmaceuticals Inc (IPIX)

[TheDane]

Looooooooong...I emailed it to myself for later reading. Thanks!

[Rdunn88]

Here’s the day Brilacidin’s name was established. Lots has happened in 8 years since. https://www.globenewswire.com/news-release/2012/06/12/479275/259063/en/PolyMedix-Receives-USAN-Approval-for-Generic-Name-of-Brilacidin-for-PMX-30063.html

[Justfactsmam]

BIngo... and there is more. ( but you should have let the lazy, negative Dr work for it.)

[attilathehunt]

Great read!! Thank you!!

[KMBJN]

Great interview. I will now think of brilacidin as "the shield of life" to match "the guardian of the genome."

[rmzport]

Thank you! You're kind to share so much with those who invest here!
I will comb through this with great interest!

[Rdunn88]

Another Q&A with Nicholas Landekic... These EX-Polymedix guys must be thinking what went wrong...

https://www.ceocfointerviews.com/interviews/PYMX-PolyMedix.htm

Nicholas Landekic
Co-Founder, President and CEO

Interview conducted by:
Lynn Fosse, Senior Editor
CEOCFOinterviews.com
Published – April 12, 2007

BIO:
Nick has had one of the most successful and respected careers of any healthcare executive, and has done some of the largest and most important financing and corporate licensing deals in the healthcare industry. From 2000-2002, he was President & C.E.O. and the first employee of Locus Discovery, where in two years he raised $83 million in two venture financings, hired over 50 employees, started 12 drug discovery programs, built one of the most powerful supercomputers in the world, and earned for the company the accolade "One of the 10 hottest biotech start-ups" from Drug Discovery Today magazine. Prior to Locus, from 1995-2000 he was Sr. Vice President Corporate Development & Investor Relations at Guilford Pharmaceuticals, where he concluded a $465 million deal with Amgen and a $100 million deal with Rhone-Poulenc Rorer. His deals have twice been nominated for "Allicense Deal of the Year". Prior to Guilford, from 1991-1995 he was Sr. Director, Business Development at Cephalon; from 1988-1991 Sr. Manager, Strategic Marketing at Bristol-Myers Squibb; from 1985-1988 positions in Finance and Business Development at Johnson & Johnson Corporation (McNeil Pharmaceutical); and has also worked in the research laboratories at the Mt. Sinai Medical Center from 1982-1983. He holds a M.B.A. from the State University of New York at Albany, M.S. Biology from Indiana University, and B.S. Biology from Marist College.

Company Profile:
PolyMedix is a development-stage biotechnology company focusing on treating serious, life-threatening acute disorders with biomimetics - novel small molecule drugs which mimic the activity of proteins. These are designed with a proprietary computational technology developed at and licensed from the University of Pennsylvania, focused on membrane protein and protein:protein interaction targets.

The Company is developing products in two therapeutic areas: infectious diseases, with novel antibiotic drugs which mimic the activity of the host defense proteins; and acute cardiovascular, with a new heparin antagonist. The Company is conducting advanced preclinical development and lead optimization for its i.v. antibiotic (PMX-30016, PMX-10129); and Heparin /Low Molecular Weight Heparin (LWMH) antagonist (PMX-60054) product candidates.

PolyMedix’s product opportunities have been rationally selected to strive to mitigate risk. Both the antibiotic and heparin antagonist have fast clinical trials with acute dosing (single dose to days), plus the possibility of accelerated development paths; straightforward endpoints, to objectively determine if the drug works; are areas where animal models and Phase I clinical data generally considered predictive of success; and represent major unmet medical needs and significant market opportunities.

CEOCFO: Mr. Landekic, please tell us your vision when you founded PolyMedix and where you are today?
Mr. Landekic: “The vision when we founded PolyMedix is that there are a great many high-value medical targets that are very difficult to get drugs for, specifically, membrane proteins and protein-protein interactions. Within these areas, there are huge market opportunities that exist in infectious disease and acute cardiovascular disorders. PolyMedix has a proprietary computational technology that lets us design small molecules that mimic the action of proteins, essentially, making small things do the job of big things. We sought to marry the capabilities of our computational technology with our commercial goals of developing new pharmaceutical products with rapid clinical development timelines, straightforward objective endpoints, areas where animal models are considered predicting of human activity, major market opportunities, and areas where Phase I clinical trials are often considered the critical human proof of principle. What we came up with was to develop new antibiotic drugs that work very differently than classic antibiotic drugs, in ways that would make bacterial resistance very difficult to develop, as well as some of our new products for acute cardiovascular disorders, such as a heparin antagonist. That was the vision when we started. We started PolyMedix 4 years ago and we have raised over $30 million to date, and are now a public company. We are now on the verge of taking two products into clinical development in 2007.”

CEOCFO: Why should the size of the molecule make a difference?
Mr. Landekic: “The term “small molecule” is generally used for most of the drugs that people are familiar with. These are drugs that you would take as a pill or injection. Small molecule is generally a term used to describe something that is made artificially; a synthetic compound made in a laboratory. The majority of drugs that are on the market are small molecules. Large molecules usually refer to proteins and peptides; these are biologic agents, such as that our own bodies produce. Proteins are built of building blocks called amino acids; our bodies make active molecules out of these amino acids. However, the problem with making drugs as proteins is that they can be very expensive and difficult to make. They are also not orally active, and often even if given by injection, the body may reject a foreign protein thus making it not useable for systemic applications. It has been one of the holy grails of medicine to try to create synthetic small organic molecules that mimic the activity of proteins. This is very hard to do, but this is the heart of what we do at PolyMedix.

For example, we applied our technology to the problem of infectious diseases. Bacterial infections are the 4th leading cause of death in this country. After heart attack, cancer and stroke, a person has a greater chance of dying from a bacterial infection than any other cause. We applied our computational technology to create new small organic molecules that mimic the host defense proteins to come up with a new way of fighting bacterial infections.”

CEOCFO: Where are you in the process?
Mr. Landekic: “We started PolyMedix about 4 years ago, essentially with computational algorithms. Since then we have designed, synthesized and tested several hundred compounds in both the both the antibiotic and cardiovascular programs. We hope to start our first clinical trials in 2007.”

CEOCFO: Will you be doing the clinical trials on your own or partnering?
Mr. Landekic: “We are going forward under the assumption that we will be doing clinical studies on our own, particularly the initial Phase I clinical trials, which are relatively inexpensive and easy for a small company to do. The areas that we chose to operate in, infectious disease and acute cardiovascular disorders are areas that are characterized by relatively straightforward, fast and comparatively easy clinical trials. There are many different products that can be developed in the antibiotic program. Our own internal focus has been primarily on intravenous products for the hospital market. We hope to partner other applications such as oral and topical products. ”

CEOCFO: What would you keep for yourself and how much are you willing to give away?
Mr. Landekic: “We are planning on keeping North American rights to injectable forms of our products, and are open to partnering everything else. Selling products into the North American hospital sector is relatively straightforward for a small company to do. With a marketing and sales force of perhaps 50 or 60 people, one can effectively reach the hospital market. We did that with a couple of my prior companies such as Guilford Pharmaceuticals Inc (NASDAQ: GLFD) and Cephalon Inc. (NASDAQ: CEPH). There are a number of other companies that have successfully built hospital based marketing and sales forces, such as Cubist Pharmaceuticals. However, selling oral products to the primary care market requires a much bigger sales force of thousands, which would be very difficult for a small company to do. What makes sense is to partner our oral products and products in the primary care market, which is what we plan to do, but to keep the injectable products for ourselves, because we can sell these on our own.”

CEOCFO: You also have applications that are not in the medical field like in paints and plastics; will you tell us about those?
Mr. Landekic: “These are polymeric forms of our antimicrobial compounds, and based on our same core invention of creating synthetic organic molecules that mimic the activity of proteins. For the drug applications of antibiotics, we are developing classic small molecules. For the non-drug applications, we are developing polymer materials. Essentially, one can think of polymers as taking monomeric active small molecule units and linking them together, like pearls on a necklace or beads on a chain. Polymer synthesis can be easy and inexpensive. These polymers can be used as additives to paints, plastics and textiles to make materials self-sterilizing, specifically, medical devices, consumer products and for industrial applications. This is one of the reasons we chose infectious diseases as a core area to work in, because we could develop both drug and non-drug applications from the same basic invention and technology, giving us multiple shots on goal and mitigating risk with minimal additional expenditures. The development of polymer materials is generally risk independent from the development of a drug.”

CEOCFO: What is the financial picture of the company?
Mr. Landekic: “We have raised about $31 million dollars so far since starting PolyMedix; about $27 million in equity financing, and about $4 million in grants. In early 2006, we went public via reverse merger public offering, raised over $21 million in a PIPE financing. The financial resources we have now will allow us to continue to operate the company through end of 2007 or early 2008 and will allow us to continue the development of our core programs. Like any small company we need to be opportunistic and flexible regarding seeking future financings, because developing any drug is an expensive endeavor.”

CEOCFO: Why should investors be looking at PolyMedix as opposed to the many other Biotechs out there?
Mr. Landekic: “Several reasons; first, the two therapeutic areas we have chosen to develop - infectious diseases and acute cardiovascular applications - are both areas that are characterized by having relatively short clinical development paths, objective endpoints, major market opportunities, and animal models that are generally considered predictive of human activity. For example, in the antibiotic world, if you can kill Staph bacteria in a rat, you are likely to be able to kill the same Staph bacteria in a person. In both of these areas, clinical trials are relatively fast; it’s a single dose with a heparin antagonist, or dosing for a week or two with an antibiotic. We have tried to mitigate risk in many ways, but are still addressing massive market opportunities. For example, bacterial infections are now one of the biggest medical problems and one of the biggest market opportunities, because of rapidly growing resistance to current antibiotics. Bacterial infections are the fourth leading cause of death in this country. It is a $45 billion worldwide market, and the unfortunate reality is that resistance can develop to all conventional antibiotics. Any antibiotic that acts biochemically, which all current antibiotics do, is susceptible to resistance; many consider it inevitable. Our approach to developing antibiotics is fundamentally different; our compounds act with a biophysical rather than a biochemical mechanism. This approach makes bacterial resistance much less likely to develop.”

CEOCFO: Will you tell us about your background?
Mr. Landekic: “I started out as a scientist, and have graduate and undergraduate degrees in biology. I worked for a while in research in the laboratories at Mt. Sinai Medical Center. I then realized that the greatest wonder of science is where the next grant will be coming from. That is when I cut off my ponytail and shaved my beard, and went back to school for my MBA, about 25 years ago. I then worked at Johnson & Johnson (NYSE: JNJ) for several years in finance and business development. I then went to work at Bristol-Myers Squib Co. (NYSE: BMY) for several years in marketing and product management. From there I went to Cephalon in business development. While with Cephalon, I in-licensed Provigil, which continues to be Cephalon’s lead product with over $750 million in annual sales. I then worked for Guilford Pharmaceuticals for five years as Senior Vice President of corporate development and investor relations, where I did over $500 million dollars worth of licensing deals. From there I went to become the President and CEO and first employee of Locus Pharmaceuticals, Inc., a venture capital backed drug design technology company, and raised $83 million in venture capital financing. Finally, four years ago I founded PolyMedix.”

CEOCFO: So you have the business and the science!
Mr. Landekic: “Yes, I do. Developing pharmaceutical products is a complicated, difficult, technology-driven business. I personally think it is important to understand and appreciate both the business and the science if one wants to successfully turn science into profits”.

CEOCFO: In closing, what should people reading this interview remember most about PolyMedix?
Mr. Landekic: “What we try to do at PolyMedix is innovation, but with risk mitigation. We are focused on developing innovative products; small molecules that mimic the activity of protein as a disruptive business model, this is a big deal. We have shown that we can successfully create products with our technology, and hope to have two compounds entering clinical development this year. The therapeutic areas we have chosen to work in have been rationally and strategically selected; acute cardiovascular and infectious diseases are both characterized as having relatively fast, inexpensive and straightforward clinical trials, and are both areas where Phase I human trials, the first human testing, is often considered clinical proof of principle. However, these are also blockbuster market opportunities. At the same time we are developing drugs, we are also trying to mitigate risk by developing antimicrobial polymers for materials uses. Our scientific founders from The University of Pennsylvania are world renowned, members of the National Academy of Sciences, and universally regarded as the world leaders in biochemistry and biophysics. Most importantly, we have a highly experienced management team in place at PolyMedix - all of us have turned science into profits many times before, and we plan to do it again at PolyMedix.

[LitesOut]

That Polymedix CEO interview is an amazing read, thank you for digging it up, SLC. I've been a shareholder since 2012 and at one point remember reading/learning all of these things. That's what made me so excited about acquiring the technology and Brilacidin in the first place (in addition to my excitement about Kevetrin). I remember a PR about having an agreement in place to use B as an anti-microbial polymer in joint implants if B got approved for any indication, but that was many moons ago (I also appreciate the astrology DP70 :) ). It's fantastic to read all the commentary of Mr. Landekic from years past.

If B is allowed to fully realize its scope of treatments this could literally become the go-to drug for most illnesses, either in combo or solo. Landekic even discusses integrating B into surgical equipment, coating SCHOOLS & HOSPITALS(!?), etc with B. Literally almost unbelievable (for me) market potential. I try avoiding hyperbole, especially in what I deem serious situations, so I don't make my prior statements without serious consideration. Working in finance with clinicians and clinical trials the last handful of years has only deepened my appreciation for B.

Thankfully I bought significantly more shares last year/earlier this year because I continued to believe in the science and the wanted to average down. I'm now green for the first time in five years. It's unfortunate a global pandemic was needed to get B to this point as it seems to be a wonder-drug of immense capability. When you read this interview and think of all of the possible indications the seemingly "outlandish" valuations people mention become quite realistic.

Thank you to all who have contributed to this board for many years and the new contributors/longs as well. I expect many more exciting developments in the days/weeks/months/years ahead.

-LitesOut