Can you re-introduce Tosk and the unmet needs that your pipeline products address?

Tosk is a small-molecule drug discovery and development company, with a unique twist in pursuing the oncology space. Rather than developing entirely new therapies that often serve limited patient populations, we focus on blocking the adverse side effects of existing, widely used cancer therapies. While new therapies can be very expensive, our approach is intended to reduce the overall cost of care by making existing therapies more effective and by eliminating the need to treat side effects.

We have four products in the pipeline, the most advanced being TK-90, which has just completed a series of clinical studies in head, neck, and colon cancer patients. TK-90 addresses the mucositis and pulmonary fibrosis caused by several widely used cancer therapies.

We are currently performing a dose optimization study using a single dose of TK-90 in head and neck cancer patients receiving a combination of chemotherapy and radiation therapy. Results to date show that TK-90 can block virtually all of the mucositis caused by this therapy. Our goal is to initiate a Phase 2b/3 registration study for TK-90 in the US and other countries by the end of this year. Why choose the avenue of improving existing therapies rather than coming up with new ones?

Anyone who has had cancer or watched a loved one suffer knows that the adverse effects of cancer therapy are often worse than the disease itself. Many patients do not complete the recommended course of therapy due to side effects. And side effects can be debilitating and potentially fatal. Palliative relief medications treat the symptoms, not the underlying disease, and offer only modest benefits. So, we viewed side effect prevention as a significant unmet medical need.

Later, we found that we could develop side effect-blocking drugs that reduced the cost of cancer therapy because treating side effects can add tens of thousands of dollars to the cost of care. Also, we observed in animal studies that healthier animals responded better to cancer therapy than those that were suffering from the side effects of treatment. We think that will be true in humans as well. And because patients will not have to limit the dosing of their cancer therapy due to side effects, their treatments will have a better chance of overcoming the cancer.We think the combination of a better quality of life, lower cost of care, and more effective cancer treatment make a compelling argument for cancer therapy adverse effect prophylaxis. How useful are fruit flies in biological research for cancer therapies?

The fruit fly is a long-standing tool for many aspects of developmental biology and for oncology. Six Nobel prizes have been awarded for work in fruit flies. However, Tosk is the first company to harness the fruit fly as a discovery tool for new drugs that block the adverse effects of existing therapies. We have found that this approach yields drugs that would not have been found using traditional target discovery or high throughput screening methods. It is with this tool that we discovered TK-90. How have you seen investor interest shape up in the biotech space over the past few years?

Simply put, 2022 and 2023 were abysmal for biotech. There was over-exuberance in biotech investing early during the COVID epidemic, and this could not be sustained, resulting in a pullback in both public and private markets. Most analysts expect a return to normalcy in 2024. Our goal is to continue to make progress with our pipeline products, and we believe that this will ultimately be recognized by financial investors regardless of market conditions. What makes Tosk a compelling story going forward?

We have established a clear leadership position in addressing a significant unmet medical need. Results to date for TK-90 have exceeded expectations, and the FDA has told us it is eligible for Breakthrough Therapy Designation. We plan a Phase 2b/3 study later in 2024 for TK-90, and shortly after we anticipate moving our second drug in the pipeline, TK-39, into the clinic. We have two other research projects that fill out our pipeline which add to our strong and diversified portfolio focused on side-effect prevention.