Could you introduce your company to our readers?
UroGen is a biotech company innovating new therapies for the unique needs of patients with urothelial cancers. We specialize in combining UroGen’s proprietary reverse-thermal hydrogel technology which is uniquely designed to allow for localized delivery in the urothelial canal, offering increased dwell time of the medicine over several hours. This is crucial as medicines are typically voided out with urine quickly, necessitating repetitive surgeries for elderly patients. Our technology provides a novel approach to treating patients that we believe offers a better option in a traditionally ignored disease.
Our R&D program leverages the benefits of known therapies by employing a great deal of scientific rigor to improve on them to meet the needs of the doctors and patients we serve in the present. For example, we are studying the use of chemotherapeutics like mitomycin combined with our reverse-thermal hydrogel technology platform to treat low-grade non-muscle invasive bladder cancer and are exploring immuno-oncology mono and combination therapies to treat other specialty cancers. Our approach is pioneering, especially as there have been no approved medicines for upper tract urothelial and low-grade bladder cancers.
What are the main challenges of innovating in the field of urology?
Urology, particularly urothelial cancers, presents unique challenges. The ability to treat locally minimizes the need for systemic drugs and avoids their side effects. The urothelial's warm, wet surfaces, where urine is voided, make treatment challenging. This has led to limited innovation historically. Our focus is on locally treating urothelial cancers and, in the future, expanding to other specialty cancers. There has also been interest in treating other urologic diseases such as Kidney stones and overactive bladder using our hydrogel technology.
How do technological advancements like AI and CRISPR impact urology and your work?
Technological advancements are transforming urology. Urothelial cancers, once neglected, are now at the forefront of innovation.
This is evident in the increasing treatments and technologies being applied, like immuno-oncology. While we have many treatments, a cure remains elusive, necessitating continuous innovation. New technologies, including gene therapies, are being introduced, and AI's potential in understanding cancers better is immense. For example, as AI plays an increasingly significant role in diagnostic processes, there may be a transformative impact on the profile of patients encountered by healthcare professionals at the time of diagnosis. Consider a scenario where a majority of cancer cases are consistently identified at their earliest stages. Envision the ability to uncover previously unnoticed trends within the vast troves of collected data. Such advancements would not only reshape the therapeutic strategies needed to meet future patient requirements but also redefine the entire treatment paradigm. Our focus is on using these technologies to advance treatment and search for cures.
Can you comment on the role of policy and investment in the biotech sector, particularly regarding the IRA and its impact?
The IRA and Medicare's drug price negotiations are major concerns. The U.S. has historically led the world for biotech innovation due to its willingness to pay for innovation. However, current policies might discourage companies from developing treatments for smaller patient populations, potentially hindering development of needed treatments. If we are not careful, we will limit access to the best therapies for patients across many diseases. The IRA and the 340B discount program are altering the industry's landscape, and we must be cautious to ensure these changes do not result in unintended consequences.
Where does the lack of understanding about the biotech industry come from, and how might upcoming elections impact it?
Many people are not fully aware of the R&D complexities involved in attempting to bring a drug to market, where in some cases the costs can exceed $2 billion. This lack of understanding is evident even among my acquaintances. An interesting example is the case of a former Wall Street Journal writer who initially held negative views about our industry. However, after working with us, her perspective changed drastically. She realized that our primary focus is on patient welfare. The upcoming elections are crucial as they could significantly influence the direction of our industry. The fact that cancer and heart disease can be viewed as chronic diseases is not a coincidence. There is a real threat to our industry and voters need to consider the implications of their choices on the biotech sector.
What's the future outlook for UroGen?
UroGen is in a very unique position, and we are just beginning to unveil its potential. When I joined, one of the first things we did was to develop a long-term strategy ensuring we develop a sustainable growth business that addresses the highest unmet needs in urothelial and specialty cancers. The Company aims to develop truly innovative medicines that advance the current standard of care. We're proud to be the first company with an approved medicine for low-grade upper tract urothelial carcinoma, and we're aiming to launch the first medicine to treat low-grade, non-muscle invasive bladder cancer.
Our strategy involves leveraging our technology and expertise to revolutionize treatment for urothelial cancer patients and other overlooked specialty cancers. As a small company, UroGen can focus on areas with higher unmet needs, which don't necessarily require blockbuster drugs. Our medicines achieved unprecedented clinical results. In 2024, we look forward to the additional data from our pivotal study for our pipeline product for low-grade intermediate-risk bladder cancer, submitting a new drug application and potential FDA approval in early 2025.
Could you share a personal moment when you realized the significant impact of your work on people's lives?
A profound moment came last summer when I first saw the data from our Phase 3 study. I was at the airport when my chief medical officer called. The results were better than expected, and I was overwhelmed, realizing the difference our medicines could make for patients. This was a pivotal moment in my career, a culmination of many years of fighting to make a difference and reinforce why I work in this industry. Our work has the power to meaningfully change the lives of patients and their families. There is no better reward.
