We are a clinical-stage oncology company focused on expanding the breakthrough potential of targeted radiopharmaceuticals to large patient populations, including those not addressed by existing platform technologies. The field of targeted radiopharmaceuticals is currently led by two marketed products that illustrated transformative survival outcomes and quality of life benefits can be conferred by delivering radioisotopes to solid tumors. These leading products, which target prostate specific membrane antigen or somatostatin-2 receptor, are each currently approved in only one tumor type yet have seen considerable commercial uptake and have become fundamental pillars of cancer treatment. Despite these advances, we believe that the field of radiopharmaceuticals is still in its infancy, with many emerging companies still primarily focused on these same two targets. In contrast, we see a significant opportunity to broaden the cancer patient populations benefiting from targeted radiopharmaceuticals by developing next-generation technologies that expand the scope of tumor targets for which it is possible to safely deliver a powerful payload of an alpha-emitting radioisotope. To ensure patient demand is reliably met, we are also establishing efficient end-to-end supply, with a combination of critical internal capabilities paired with established external vendors. Through these efforts, we seek to maximize clinical utility across multiple indications in multiple tumor types, and to expand the commercial uptake of radiopharmaceuticals beyond the traditional nuclear medicine setting and into the more expansive clinical oncology setting. We have built a proprietary miniprotein radioconjugate platform that aims to safely confer breakthrough efficacy to a broad range of patient populations. Our miniprotein radioconjugates are designed to selectively deliver the tumor-killing properties of radioisotopes to targeted tumors with high tumor penetration and prolonged retention, while being rapidly cleared from normal organs and tissues to minimize systemic radiation exposure. Our miniproteins have demonstrated the ability to potently bind to tumor targets outside the scope of current delivery technologies such as peptide-based radioconjugates. Although our proprietary miniprotein radioconjugate approach is novel, and as such has risks and the potential for significant challenges, we are leveraging the capabilities of our platform technology, together with our expertise and know-how in radiopharmaceutical development, supply chain and manufacturing, to address these challenges with the aim of advancing a deep pipeline of programs against a broad range of tumor targets that have not been successfully targeted with radiopharmaceuticals. Our platform capabilities have generated a pipeline of several novel product candidates. Our most advanced program is a radiopharmaceutical targeting Nectin-4. It is a miniprotein radioconjugate with multi-indication potential across multiple tumor types, in clinical development for the treatment of locally advanced or metastatic urothelial cancer, or UC, and multiple other Nectin-4 expressing solid tumor types. The learnings from the optimization of our Nectin-4 program, the first miniprotein radioconjugate ever advanced into human investigational studies, are being applied to benefit the development of our robust pipeline of several other unpartnered miniprotein radioconjugate programs, which are designed to address other clinically-validated targets. Our second program has recently advanced to human clinical imaging, targeting B7-H3, a clinically-validated target expressed in several tumor types, including lung, prostate, breast, and several other cancers, exemplifying our ability to leverage the learnings from our Nectin-4 program. Our lead product candidate, [225Ac]Ac-AKY-1189, contains a miniprotein, AKY-1189, that specifically binds to Nectin-4, and is conjugated via chelation to actinium-225, 225Ac. 225Ac is an alpha-emitting radioisotope payload that when conjugated to a prostate specific membrane antigen, or PSMA, binding peptide, has been shown to confer increased anticancer activity in the post-chemotherapy setting of metastatic castration-resistant prostate cancer compared to an identical PSMA binding peptide with beta-emitting Lutetium-177, or 177Lu. Nectin-4 is a surface protein found on a wide variety of tumors and has very limited expression in normal adult tissues. Nectin-4 is also the target of Padcev, an antibody-drug conjugate, or ADC, approved worldwide for the treatment of locally advanced or metastatic UC. Padcev had worldwide sales of $1.9 billion in 2024, with estimated peak sales of up to $7.0 billion. Despite the commercial success of Padcev, its impact beyond UC has been limited likely due to the need to develop a companion diagnostic for tissue testing when utilizing an ADC. In contrast, we intend to use imaging radioisotopes conjugated to AKY-1189 to select patients most likely to benefit from therapeutic treatment with [225Ac]Ac-AKY-1189. We believe the commercial impact of Padcev validates Nectin-4 as an anticancer target in UC and that significant unmet medical need exists for our lead product candidate in post-Padcev UC. Additionally, we see potential to treat several non-UC Nectin-4-expressing tumor types such as breast cancers and lung cancers; however, our lead product has not yet been approved for sale, and if approved may not achieve the same level of commercial success as Padcev. We believe that the therapeutic potential of [225Ac]Ac-AKY-1189 across multiple tumor types is supported by our preclinical studies and data collected by a third-party physician in South Africa pursuant to Section 21 of the Medicines and Related Substances Act, or MRSA, which demonstrated the ability of radiolabeled AKY-1189 to specifically localize to Nectin-4 expressing tumors and rapidly clear from normal organs and tissues. In April 2025, the U.S. Food and Drug Administration, the FDA, cleared our Investigational New Drug, or IND, application for [225Ac]Ac-AKY-1189 for the treatment of locally advanced or metastatic UC and other Nectin-4 expressing tumors. We have commenced a multi-site Phase 1b clinical trial in the United States and anticipate preliminary results from the Part-1 dose escalation portion of this trial in the first quarter of 2027. To overcome the manufacturing challenges and supply chain reliability issues that have historically hindered the development and commercialization of radiopharmaceuticals, we are focused on investing in manufacturing and ensuring supply chain continuity and reliability. We have built significant internal capabilities, including subject matter expertise for our product manufacturing processes and a state-of-the-art radiopharmaceutical development suite. Additionally, we have partnered with multiple domestic and international isotope suppliers that provides us priority access to 225Ac, and with multiple contract manufacturers for the production of our drug product, which collectively are designed to create redundancies across all components of our supply chain. We are also establishing our own current good manufacturing practice, or cGMP, facility to enhance flexibility, increase control, and establish a hybrid internal and external clinical supply chain. We believe our team’s expertise and experience in the development of radiopharmaceuticals will allow us to address the challenges presented by the half-life of radioactive isotopes and establish an efficient supply chain from production to patient administration. We believe that radiopharmaceuticals represent one of the most promising modalities for the treatment of solid tumors. Approved radiopharmaceuticals have demonstrated the ability to overcome the challenges of conventional cancer treatments and provide patients with targeted therapies that have superior efficacy and better tolerability. Although [225Ac]Ac-AKY-1189 has not received FDA approval required for commercial sales, we believe our approach is validated by, and builds upon, the clinical and commercial success of current radiopharmaceuticals and that our approach has the potential to further transform the cancer treatment paradigm for large patient populations. • Clinical validation of targeted radiopharmaceuticals. Approved beta-emitting radiopharmaceuticals Pluvicto and Lutathera, have demonstrated statistically significant and clinically meaningful overall survival, progression-free survival and quality of life benefits in global registrational clinical trials. Early-stage clinical trials have also demonstrated that the use of alpha-emitting 225Ac radioconjugates can deliver more profound anticancer activity than beta-emitting 177Lu conjugates in similar patient populations, and in patients whose disease has progressed on prior beta-emitting targeted therapies. These promising early clinical data have led to the advancement of 225Ac-based radioconjugates to pivotal clinical trials, though none yet have filed for approval by the FDA. • Commercial validation of approved radiopharmaceuticals. Pluvicto achieved a first full year of sales of approximately $1 billion, representing the strongest oncology commercial launch since Ibrance in 2015, which demonstrates the patient impact potential and rapid adoption of radiopharmaceuticals into clinical practice. The estimated global peak sales for Pluvicto are approximately $5.4 billion in prostate cancer alone. The global radiopharmaceuticals market is one of the fastest growing categories among anticancer medicines and is projected to grow to over $26 billion in sales by 2032. The therapeutic segment of this market is estimated to achieve a total addressable market of $25 billion to $60 billion post-2030. • Strategic validation of radiopharmaceuticals. The commercial success of radiopharmaceuticals, paired with significant increases in investment in innovative approaches, has led to significant value creation through partnering and acquisitions. Aggregate transaction values over the last 10 years are approximately $33 billion. Several large multinational biopharmaceutical oncology leaders have also been significantly investing in radiopharmaceutical operations globally. We believe that the continued capital investment and expansion of operations and the advancement of supply chain capabilities represent recognition of the significant medical and commercial opportunity for radiopharmaceuticals. We were originally incorporated under the laws of the State of Delaware in August 2020 under the name HotKnot Therapeutics, Inc. We changed our name to Aktis Oncology, Inc. in April 2021. Our principal executive offices are located in Boston, Massachusetts.
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