Nucleus RadioPharma is a Contract Development and Manufacturing Organization (CDMO) operating in the field of radiopharmaceuticals.
Can you describe your professional background and its relevance to your current role at Nucleus RadioPharma?
I am a board-certified nuclear pharmacist with a career spanning over two decades. My previous ventures include founding Artemis, which innovates in cyclotron targetry for diagnostic agents, and managing the Jubilant Radiopharmacy Network. This extensive experience in startups and radiopharmaceutical logistics highlighted the demand for the innovative treatments we are developing at Nucleus, particularly in radioligand and targeted alpha therapies. These therapies, which link low-energy isotopes to cancer-targeting molecules, allow for precise tumor treatment while minimizing damage to surrounding tissues, representing a significant shift from traditional cancer treatments.
What inspired you to join Nucleus RadioPharma?
My decision was driven by the rapid scientific progress and the burgeoning investment in the radiopharmaceutical sector, which I observed firsthand. Over the past five years, the industry has attracted nearly $10 billion in investments and seen the emergence of 80 new companies. However, a critical gap exists in the infrastructure and expertise necessary to navigate the complex clinical and regulatory pathways that bring these innovations to market. My role at Nucleus is to bridge this gap, ensuring that cutting-edge therapies reach clinical approval and achieve commercial viability and accessibility for patients globally.
Could you elaborate on the infrastructure challenges facing the radiopharmaceutical sector and on how Nucleus is addressing these?
The radiopharmaceutical industry is particularly challenging due to the short half-life of isotopes, which complicates logistics similar to shipping ice without refrigeration. To address this, we are establishing multiple production sites across the United States to ensure timely delivery of our therapies to patients. The challenges extend beyond logistics, encompassing the need for deep knowledge of regulatory landscapes and building robust academic and clinical partnerships to advance our research and trials. Our collaboration with leading medical institutions like Mayo Clinic is vital for accessing advanced clinical settings and fostering innovations that can be rapidly transitioned from trials to treatment.
We are strategically situating our facilities near major medical centers to expedite the transfer of isotopes and drugs into patient studies and eventual commercial use. Our primary R&D facility in Rochester, Minnesota, is located close to Mayo Clinic, complemented by large manufacturing centers on both the East and West Coasts of the U.S., set to become operational between 2025 and 2026. This setup supports the swift scale-up from research to commercial phases, ensuring that we can meet the market demands efficiently. The infrastructure investment totaling over $100 million underscores our commitment to leading the development and distribution of radiopharmaceuticals.
What are the main remaining challenges that you still need to solve at Nucleus?
One of our primary challenges is building the necessary infrastructure to meet the aggressive demand and timelines for our radiopharmaceutical products. Completing these complex construction projects is crucial to ensure timely commercial availability of our drugs, a process complicated by post-COVID construction delays. Furthermore, we face public perception issues related to the use of radiation in medical treatments, often misunderstood due to its association with danger. It is vital that we educate communities on the safety and necessity of these facilities to overcome the 'not in my backyard' syndrome.
Can you discuss the significance of your partnerships with isotope suppliers, such as with Eckert & Ziegler?
Our partnerships, like those with Eckert & Ziegler, ARTBIO, SHINE Technologies and other suppliers, are crucial for securing a reliable isotope supply, which is essential given that we do not manufacture isotopes ourselves. These collaborations enable us to integrate these isotopes into pharmaceuticals for larger companies, facilitating advancements in treatment options. The partnerships are integral to our supply chain strategy, ensuring that we can provide continuous access to necessary materials for drug development and delivery across the global market.
What are your projections for the growth of the radiopharmaceutical sector?
The radiopharmaceutical market is poised for substantial growth, with projections ranging from $30 billion to $100 billion by 2030. This optimism is reflected in the intense interest from investors, evidenced by our successful funding rounds, including a recent $56 million Series A. The sector is on the brink of transformative advancements, with promising treatments for prostate, breast, lung, and renal cancers. Investor enthusiasm underscores a widespread recognition of the potential for radiopharmaceuticals to revolutionize cancer treatment, significantly enhancing efficacy and patient outcomes.
Among other things, the complexity of delivery renders radiopharmaceuticals expensive. Do you see a possibility for cost reduction?
Indeed, the drugs we produce are costly due to their life-saving nature and the intricate manufacturing processes involved. The pricing of radiopharmaceuticals is justified due to their distinct capability to verify their effectiveness through diagnostic imaging prior to their therapeutic use.
This targeted approach avoids unnecessary treatments, presenting a cost-effective solution in the long run. As our production scales up, we anticipate achieving economies of scale that will help reduce costs, maintaining cost-effectiveness compared to other therapies.
Do you have plans to expand outside of the United States?
Currently, our primary goal is to establish and expand our operations across the United States. We aim to solidify our infrastructure and ensure we can meet domestic demand before considering international expansion.
In the next two to three years, as we stabilize our processes and increase our capacity, we will explore strategic international partnerships that can facilitate our global reach without compromising our operational focus.
What are your goals for Nucleus RadioPharma in the next three years?
In three years, I hope to report that our east and west coast facilities are fully operational and successfully distributing our products. We aim to expand beyond prostate cancer to include other cancers and utilize a broader range of isotopes, ensuring consistent and reliable drug delivery to meet market needs. Looking further ahead, we're developing technologies to enable the use of our treatments in local and regional medical centers, reducing the need for patients to travel to major hospitals. This expansion will likely require building additional manufacturing sites and enhancing our shipping capabilities to maintain the efficacy of our treatments upon delivery.
