Executive Summary / Key Takeaways

• Radiopharm Theranostics ($RADX) is an early-stage radiotherapeutics company with a diverse pipeline of six platform technologies and a joint venture, strategically positioned to address high unmet medical needs in precision oncology.
• The company's core investment thesis hinges on the successful advancement of its differentiated radiopharmaceutical technologies through clinical trials and regulatory approvals, aiming to transform significant R&D investments into future commercial revenue streams.
• Recent financial performance for fiscal year 2025 shows a reduction in total comprehensive loss to A$37.88 million from A$47.75 million in fiscal 2024, driven by R&D tax incentives and reduced contingent consideration losses, alongside increased R&D expenditure of A$27.52 million.
• Key pipeline assets like RAD202, RAD204, RAD101, and RAD301 are progressing through Phase I and Phase II trials, with several Phase II and Phase III initiations expected by late 2026 and early 2028, signaling critical near-term catalysts.
• Strategic partnerships with industry leaders like Lantheus Holdings (LNTH) and academic powerhouses such as MD Anderson Cancer Center are crucial for accelerating clinical development and mitigating resource constraints, enhancing the company's competitive stance.

The Dawn of Precision Radiotherapeutics

Radiopharm Theranostics ($RADX) stands at the forefront of a burgeoning field, dedicated to developing innovative radiopharmaceutical products for both diagnostic and therapeutic applications in precision oncology. Incorporated in Australia in February 2021, the company has rapidly assembled a robust pipeline of targeted technologies, aiming to redefine cancer treatment for areas with significant unmet medical needs. The global market for these indications is estimated to exceed US$6 billion annually, underscoring the substantial economic potential and patient benefit.

The broader nuclear medicine market is experiencing robust growth, with over 40 million procedures performed annually and demand for medical radioisotopes increasing by approximately 5% each year. This expansion is fueled by an intensifying focus on theranostics—drugs or methods that combine diagnosis and treatment. Advances in antibody and small-molecule design, coupled with the increasing availability of potent radionuclides, are driving interest in targeted radiotherapy. This trend emphasizes high linear energy transfer therapies, which deliver ablative radioactive doses precisely to cancerous cells over a small range, minimizing damage to adjacent healthy tissues.

A Differentiated Technological Arsenal

Radiopharm's strategy is built upon a diverse portfolio of six licensed platform technologies, encompassing peptides, small molecules, and antibodies, each designed to target specific cancer cells with innovative mechanisms of action. This multi-pronged approach aims to overcome the limitations of traditional therapies and existing radiopharmaceuticals.

The Nano-mAbs platform utilizes genetically engineered camelid-derived single domain antibodies (sdAb), or nanobodies, which can be labeled with radioisotopes. These nanobodies, targeting receptors like HER-2, PD-L1, and PTK7, offer distinct advantages over conventional monoclonal antibodies (mAbs). Their smaller size results in shorter circulation times, deeper tumor penetration, and high specificity to the target, potentially leading to more effective diagnosis and treatment. For instance, RAD202, a therapeutic Nano-mAb targeting HER2 breast and gastric cancer, commenced Phase I in Australia in the second half of 2024, with Phase II in the US anticipated in the second half of 2026. Similarly, RAD204, for non-small cell lung cancer, began Phase I in Australia in January 2024, with Phase II in the US expected by the fourth quarter of 2026.

The Pivalate platform features 18F-FPIA, a small molecule radiotracer. This technology is designed for the detection, characterization, and progression monitoring of glioblastoma and brain metastases. A key differentiator for Pivalate is its ability to cross the blood-brain barrier, leading to significant uptake in tumor lesions. It selectively targets fatty acid synthetase, which is overexpressed by tumors but not by normal brain cells. RAD101, the diagnostic Pivalate asset for brain metastases, received IND approval from the FDA in July 2024, with a Phase IIb trial expected to complete by the first quarter of 2026 and Phase III planned for the second half of 2026.

Avβ6-Integrin (Trivehexin) represents another novel small molecule platform. Trivehexin is engineered to bind to the avβ6-integrin antigen, which is exclusively expressed on epithelial cells and overexpressed by various carcinomas, including pancreatic ductal adenocarcinoma (PDAC), head-and-neck cancer, and certain lung cancers, while being absent in normal pancreatic tissue. This selective binding offers a significant advantage for targeted imaging and therapy. RAD301, the diagnostic asset for pancreatic cancer, began its Phase I trial in the US in February 2024, with Phase II expected to start by the first half of 2026.

The PSA-mAb platform is based on a humanized monoclonal antibody designed to target free human prostate kallikrein (PSA) in prostate cancer cells. When combined with radioisotopes like Tb161, this platform holds the potential for curative treatment through sustained tumor regression and a significant increase in median survival time. RAD402, the therapeutic PSA-mAb asset, is anticipated to commence a Phase I trial in Australia after Ethics Committee approval, expected by the end of 2025.

The PTPµ (PTPmu) platform introduces a highly specific peptide molecule biomarker present exclusively in tumor cells. This agent functions as both a PET imaging agent with low-level radiation and a radiopharmaceutical theranostic with high-energy radiation to destroy tumors. Its unique specificity for tumor cells, even those far from the main mass, offers a compelling advantage in recognizing the full extent of invasive tumors.

Finally, Radiopharm Ventures LLC, a joint venture with the prestigious MD Anderson Cancer Center, is developing novel radiopharmaceutical products. Its first therapeutic candidate is a humanized IgG antibody targeting the tumor-specific antigen B7-H3, which is highly expressed in multiple solid tumors but not in healthy cells. This B7-H3 mAb received IND approval in July 2025, with a Phase I clinical trial in the US planned to initiate by the end of 2025. Pre-clinical studies suggest its effectiveness in eliminating resistant colorectal cancers in lab models.

Strategic Alliances and Pipeline Progression

Radiopharm's strategic approach extends beyond its internal R&D capabilities, emphasizing crucial partnerships to accelerate development and de-risk its pipeline. The collaboration with Lantheus Holdings, a leader in radiopharmaceuticals, exemplifies this strategy. In June 2024, Lantheus Omega, LLC invested in Radiopharm by purchasing 149.63 million ordinary shares. This was followed by a strategic development services contract in October and December 2024, where Radiopharm leads clinical development efforts in Australia for Lantheus, with Lantheus covering all associated costs and Radiopharm eligible for up to US$2 million in one-off milestone payments. This arrangement provides non-dilutive funding and leverages Lantheus's commercial expertise.

The joint venture with MD Anderson Cancer Center, Radiopharm Ventures LLC, is another cornerstone of the company's strategy. This partnership grants Radiopharm Ventures access to MD Anderson's intellectual property, allowing for the development of up to four clinical products. The B7H3 mAb, the first candidate from this venture, has already received IND approval and is slated for a Phase I trial by the end of 2025. These alliances are critical for a clinical-stage company, providing access to capital, expertise, and infrastructure that would be challenging to build independently.

Financial Performance: Investing in Future Growth

As a clinical-stage biopharmaceutical company, Radiopharm Theranostics has a history of significant operating losses and negative cash flows, a common characteristic in this R&D-intensive sector. For the fiscal year ended June 30, 2025, the company reported a total comprehensive loss of A$37.88 million, an improvement from A$47.75 million in fiscal 2024. This reduction was primarily due to the recognition of A$3.6 million in R&D tax incentives for fiscal 2024 and a A$4.8 million decrease in the loss on movement in contingent consideration, reflecting progress in its development programs.

Revenue from contracts with customers saw a substantial increase, rising from A$299,228 in fiscal 2024 to A$3.63 million in fiscal 2025. This growth was largely attributable to the strategic development services contract with Lantheus, where revenue is recognized based on reimbursement for costs and achieved milestones. Other income also surged to A$10.26 million in fiscal 2025, primarily from the recognition of R&D tax incentives.

Research and development expenses, the lifeblood of a biotech company, increased from A$23.09 million in fiscal 2024 to A$27.52 million in fiscal 2025. This rise reflects intensified clinical trial activities across its diverse pipeline, including increased spending on NanoMab, RD Venture, Pivalate Imperial, huPSA Anti-body Diaprost, and AVB6 Integrin programs. General and administrative expenses also increased to A$14.64 million in fiscal 2025, driven by higher employee benefits and operational costs associated with expanding its public company infrastructure.

From a liquidity perspective, Radiopharm held cash and cash equivalents of A$29.12 million as of June 30, 2025. Management anticipates that current cash resources will be sufficient to fund operations through fiscal 2026. However, the company acknowledges the need for substantial additional funds to achieve its long-term goals and complete the development of its drug candidates, with future financing dependent on market conditions and investor sentiment. Net cash used in operating activities increased to A$36.65 million in fiscal 2025, reflecting the escalating costs of clinical trials. This was offset by a significant increase in net cash provided by financing activities, which rose to A$45.43 million, primarily from equity issuances.

Competitive Landscape: Carving a Niche in a Crowded Field

The radiopharmaceuticals market is highly competitive, populated by multinational pharmaceutical companies and specialized biotechnology firms with significantly greater financial and operational resources. Radiopharm Theranostics positions itself as an innovator, focusing on novel targets and differentiated technologies to carve out niches in areas of high unmet medical need.

Established players like Novartis (NVS), through its Advanced Accelerator Applications (AAA) division, primarily focus on peptide-based radioligand therapies, such as Lutathera and Pluvicto. While Novartis boasts a global footprint and robust commercialization capabilities, its focus primarily on peptides, rather than sdAb or mAbs, presents an an opportunity for Radiopharm's nanobody and monoclonal antibody platforms to offer distinct therapeutic approaches. Similarly, Telix Pharmaceuticals (TLX) and Clarity Pharmaceuticals (CU6) are significant competitors, with Telix utilizing different small molecule and monoclonal antibody targets, and Clarity focusing primarily on copper isotopes. Radiopharm's diverse portfolio across various molecular sizes and radioisotopes provides a broader attack surface against different cancer types and mechanisms.

Radiopharm's nanobody technology, with its shorter circulation times, deeper tumor penetration, and high specificity, offers a potential advantage over larger monoclonal antibodies used by some competitors, allowing for more precise targeting and reduced off-target effects. The Pivalate platform's ability to cross the blood-brain barrier is a critical differentiator in the challenging brain metastases and glioblastoma markets, where many existing imaging agents are suboptimal. Furthermore, the avβ6-integrin target of Trivehexin, being exclusively expressed on epithelial cells and overexpressed by carcinomas... but completely absent in normal pancreatic tissue, provides a high degree of specificity that could lead to superior therapeutic indices compared to less selective agents.

Despite its innovative technology, Radiopharm faces vulnerabilities due to its smaller scale and early-stage status. Larger competitors possess superior manufacturing, marketing, sales, and supply chain resources. Radiopharm's reliance on third-party manufacturing and supply partners introduces risks related to quality and availability. However, strategic partnerships, such as the one with Lantheus, help mitigate some of these disadvantages by providing access to established infrastructure and expertise. The joint venture with MD Anderson further strengthens its R&D capabilities and intellectual property pipeline, allowing it to compete more effectively in developing novel therapeutic products like the B7-H3 mAb.

Risks and Opportunities

Investing in a clinical-stage biopharmaceutical company like Radiopharm Theranostics inherently involves significant risks. The company's history of operating losses and may not achieve or maintain profitability in the future, with substantial and increasing R&D costs expected as clinical trials advance. The need for additional financing is a persistent challenge, and the ability to raise sufficient capital is subject to market conditions and investor sentiment.

Clinical trials themselves present numerous hurdles, including difficulties in patient enrollment and retention, which could delay or prevent clinical trials and make those trials more expensive to undertake. Regulatory approvals are never guaranteed, and even with approval, products may still face development and regulatory difficulties that may delay or impair future sales. The company's reliance on third-party manufacturers and suppliers also exposes it to potential disruptions in the supply chain. Protecting its intellectual property and proprietary technology is paramount, as infringement by third parties could severely impact commercialization efforts. Furthermore, its status as a foreign private issuer carries the risk of significant additional compliance costs if that status is lost.

Despite these risks, the opportunities are substantial. The estimated US$6 billion global market for its target indications provides a significant addressable market. The company's diverse pipeline, with multiple assets in various stages of clinical development, offers several shots on goal. The strategic partnerships with Lantheus and MD Anderson provide validation and critical resources. The focus on differentiated technologies that offer superior targeting and potentially improved patient outcomes positions Radiopharm to capture significant market share if its drug candidates achieve regulatory approval and commercial success.

Conclusion

Radiopharm Theranostics is a compelling, albeit high-risk, investment proposition in the rapidly evolving field of radiopharmaceuticals. The company's foundational strength lies in its innovative and diverse pipeline of targeted diagnostic and therapeutic agents, each designed to exploit specific biological mechanisms in cancer with enhanced precision. From the unique properties of Nano-mAbs for deeper tumor penetration to the blood-brain barrier crossing capability of Pivalate and the tumor-exclusive targeting of Avβ6-Integrin, Radiopharm is strategically building a competitive moat through technological differentiation.

The company's progress through clinical trials, with several key assets advancing to later stages and strategic partnerships bolstering its development efforts, underscores its commitment to bringing these novel therapies to market. While the path to profitability is long and capital-intensive, marked by ongoing operating losses and the continuous need for financing, the potential for significant returns upon successful commercialization of even a few pipeline assets is substantial. Investors in Radiopharm Theranostics are betting on the successful execution of its R&D strategy, the strength of its technological leadership, and its ability to navigate a competitive landscape to unlock the immense value inherent in precision radiotherapeutics.