Stanley Kim, J.D., Chief Executive Officer, WinSanTor

WinSanTor is a biotechnology company focused on the development of treatments for peripheral neuropathies (PN). Could you please explain to our readers about

WinSanTor and its leading compound?

Peripheral neuropathy is a neurodegenerative condition that affects several hundred million people globally. It is the nerve damage caused by many major diseases and injuries, including diabetes, cancer/chemo, HIV, etc. Today, there is no treatment for this nerve damage, only pain treatments. The leading scientists were brought together to solve this problem. Degeneration of nerve fibers due to peripheral neuropathy has been linked to mitochondrial dysfunction. They discovered a novel pathway via AMPK, and more importantly, discovered anticholinergics that regulate nerve regrowth through mitochondrial reactivation. They’ve shown both reversal and prevention in animals and humans showing nerve growth, reduction of symptoms including pain, and improvement of quality of life. A recent study (double-blinded, controlled) presented early evidence that these drugs are efficacious in significantly improving structural and functional measures of small fiber function (IENF density, improvement in neuropathy scores, pain questionnaires) and quality of life (Norfolk QOL DN survey) in T2DM subjects. No improvements were seen in the placebo group. WinSanTor was established to advance this science with its lead drug, WST-057, now in phase 2.

With strong academic roots, WinSanTor’s primary objective is to ensure the development of high impact drugs for patients with the greatest likelihood of success. We have an experienced drug development team, use the leading CROs, work with the leading clinicians in the space with strong academic credentials, and try to use the science, not the business, to guide the development. We reduce significant risk by reusing as many resources and processes as possible. WST-057 is a topical drug recycling a previously approved API (approved in most major countries but not in the U.S.) with strong safety and manufacturing history—it was originally approved in a pill for gastric ulcers. WST-057 is now in Phase 2 in several sites in Canada, with plans to begin phase 2b/3 in many of those countries where it was previously approved. We are using the data from the scientist’s previous studies in both animals and humans to guide the protocols, as well as the collective experience of nearly every clinician in the space. The goal is to see drug approval by 2022 or 2023.

What are the major philosophies, missions, and future goals of WinSanTor?

There has been a lack of basic scientific understanding of peripheral neuropathy, and past clinical studies to treat the disease have all failed (Feldman EL. et al. New Horizons in Diabetic Neuropathy: Mechanisms, Bioenergetics, and Pain. Neuron. 2017 Mar 22; 93(6): 1296—1313.) The leading researchers in diabetic peripheral neuropathy, Dr. Paul Fernyhough and Nigel Calcutt, were gathered to collectively address this growing unmet need. This expanded to recruiting the leading academic clinicians to guide the clinical development of the discoveries of these researchers. WinSanTor is merely the commercial manifestation of this collective endeavor to address this problem, which is one reason the company and its scientific works received significant funding from government stakeholders.

The company, WinSanTor, goes beyond science. By reutilizing an existing API with nearly 40 years of use as a pill for stomach ulcers, the company minimizes risks associated with most drug development, particularly as it relates to safety and manufacturing. This reduces overall cost, time to development and anxiety of potential use. Reformulating the API into a topical solution targets the API to the affected areas, minimizes systemic effect, increases safety, and makes the drug more usable. It also creates commercial value to encourage and sustain the development of the product.

The concept study in humans, the proof of mechanism, established significant evidence that the class of drugs being developed by WinSanTor can provide patients some semblance of their previous “normal” lives. This is magnified by the hundreds of millions that are affected globally including over 50% of the nearly 500 million diabetics, approximately a third of ALL cancer patients and HIV patients, and many others. WinSanTor and its team strive to impact the lives of all these patients, globally. This patient-oriented development strategy drives the company as it seeks approval of potentially the only disease-modifying treatment for peripheral neuropathy.

Along with your role as the CEO of WinSanTor, you have had various accomplishments in different fields, including biotechnology/pharmaceutical, medical device, and software. How did you shift from law school to software development, then to the biotech industry? What values led you through your career?

There are two principles that have driven my career: understanding the underlying mechanism of any problem and trying to solve the problem with useful solutions. Although I started my career as an attorney, my educational background is in life sciences, specifically genetics. The combination of the two, as well as my desire to start companies, began at The Salk Institute, whereI managed the intellectual property for the Institute. The Salk Institute is one of the top 5 biological research institutes in the world. One of these areas of research is in the field of computational neuroscience—modeling neuroscience digitally. My first two companies were in this space, which were machine learning for signal separation/processing for telecommunication/software applications, later medical devices, and computer vision software applications. Thus, most of my experiences to date are in the life sciences.

Very few times in life will anyone have an opportunity to work on something that may have the potential to impact the lives of so many people. With my previous companies, SoftMax and Emotient (a.k.a. MPT), the impact was with the caliber of the people I was working with and their potential. The technologies that were built from this group are now on every cell phone. Unfortunately, we never maximized their potential at the companies — they were sold very early. In WinSanTor, we hope we can maximize the potential for Drs. Fernyhough's and Calcutt’s work.

Development of technology in biotechnology is in many ways similar to every other field, and arguably easier as there is a formula for drug development (preclinical, phase 1, phase 2, and phase 3). The difficult part of drug development was easy in my case. My scientific colleagues were responsible for validating the science, both in animals and in humans. The API, in this case, is an established API with nearly 40 years of history. We have a strong development team, strong clinical support through leading CROs (service providers) and have the support and guidance of the leading clinicians in the space. The difficulty in the biotechnology industry is aligning drug development with the interests of the pharmaceutical industry, which I’ve now discovered is not in alignment with the discovery of impactful drugs.

Stanley Kim with his colleagues at WinSanTor

Fortunately, I’ve surrounded myself with strong personalities, including the scientists at the Salk, my colleagues, Patrick Soon-Shiong, Seth Neiman, our advisors, and others. If you are a problem solver, you learn directly and indirectly from all interactions and experiences and having iconic advisors, you learn from their experiences, both positive and negative. Following trends is not in their DNA.

As the CEO of WinSanTor, what are some significant changes or trends you have noticed in the biotechnology industry? How do you forecast the global biotechnology industry will be like in the next five to ten years?

Not coming from a biotechnology background, I observe trends differently than others within the industry. I see an over-reliance in the industry of acquisitions. It is understandable. Drug development is expensive and few people, especially investors, like to take risks particularly with new science. Therefore, companies are created to be acquired before phase 3, during which it is much riskier and very expensive, in therapeutic areas that acquirers want. With only a handful of acquirers—your starting technology, your team, your intellectual property, your strategy—everything is exclusively centered around being acquired long before the technology is validated. This is one reason that there is so much focus on certain therapeutic areas (nearly 90% of overall spend is three therapeutic areas, 60% of this just in cancer). It is also made much more difficult as drugs are not made today for the international market, but for the U.S. market (nearly 50% of ALL revenues are generated from the United States).

This may be an overgeneralization, but too many companies are created to be acquired, developing similar technologies for the U.S. market without true accountability. This is one reason I believe too many international companies developing technologies for their own market are finding it difficult, especially following this formula. This is also one of the main reasons why true innovations, at least from my perspective, have such a difficult time.

I hope there is a change in the next 5-10 years. As with most things, globalization forces industries to think internationally, both in development and commercialization. When costs (development and commercialization) are insulated, whether through subsidies or protections, it creates isolated industries reliant on the status quo. There is a strong disincentive for true innovations. The U.S. market is reliant on subsidies and patients insulated from the true cost and efficacy of the products they use. This is shifting. Insurance companies are forcing patients to absorb the cost of the drugs they use, and outside forces are looking at ways to remove the “middleman.” Pricing and affordability will be a part of every equation of developing drugs, and the ability to adapt and rely on markets outside the market will bring new industry leaders.

WinSanTor is developing a high-impact product for the international market. We are not relying on acquisition but preparing to evolve to be part of this evolution/ revolution in the healthcare market, particularly the U.S.

In the past, you founded software startups, SoftMax and Emotient, that were acquired by Qualcomm and Apple, respectively. Many startups aim to achieve innovation and results with an optimal return, as you have accomplished with your innovative technologies that now reside on many of the current smartphones. Could you please share the background of these accomplishments? Also, do you have any words of advice for startups and entrepreneurs that have the same goals?

I wish I could take credit for these accomplishments. It is only that I associated myself with individuals of such high caliber, and that I saw the potential for the technologies they were developing. Most of the credit for working with such individuals has to do with the caliber of people that are in San Diego, including The Salk Institute. It is easy to find strong science and technology in communities where talent concentrates. Knowing what is valuable or potentially valuable is more difficult. Extracting the value from where the value is not evident is even more difficult.

With the first two companies, we did not seek to be acquired. With the first two companies, my co-founders were pioneers in their respective spaces. We were trying to make the companies the leaders in their field and at some point, we realized there would be a wall to truly maximize the value of the people and the technology. The true value of the technologies that were extracted could only have come forth with large platform technology companies like Qualcomm and Apple who have the resources to exploit the technologies.

WinSanTor is arguably different. The true value of the technology is not in alignment with large pharma—who are focusing on lower-volume and higher-cost drugs. We know that we can make significant revenues by doing good for a larger population, particularly by partnering with regional pharmaceutical companies who do not have the luxury of reimbursement of subsidized high- priced drugs.

For other startups and entrepreneurs, I always start with the people and their expectations and be as specific as possible. Making money alone is not an expectation. When, how, where, etc. are all things that should be discussed. If these are aligned, then you build on all the other parts that are necessary to achieve their expectations, and you bring in others with the same expectations. Once you have imbalance, then that is usually when problems occur. Bringing in the best person is not always the best thing to do especially when that person is not in alignment with the vision of the company.

I hope that one day, we reach our expectations. but at least we seem to be on track.

April 6, 2020

Stanley Kim, J.D.

Chief Executive Officer, WinSanTor

Stanley Kim, J.D., CEO of WinSanTor, is a seasoned entrepreneur and the founder of companies in diverse industries, including pharmaceutical/biotechnology, medical device and software. WinSanTor, his current affiliation, is a clinical-stage biotechnology company focused on the discovery and development of treatments for peripheral neuropathies. WinSanTor’s mission is to simple-develop a drug that works and to impact the lives of millions of patients heavily burdened by peripheral neuropathy. His first company, SoftMax, was acquired by Qualcomm and his second company, Emotient, was acquired by Apple. Both technologies now reside on most of the smartphones.