Good morning and good evening, everyone. Thank you for joining today's call to discuss PeptiDream's first half 2026 results. Joining me on the call today are Masato Murakami, Executive Vice President of our Radiopharmaceutical business and President of our wholly-owned subsidiary, PDRadiopharma, as well as three recent additions to our executive leadership team, Catherine Ohura, Executive Vice President, Operations, Jun Kono, Executive Vice President, Strategy, and Kodo Shikata, Executive Vice President, People and Culture. I will begin by providing an overview of our business and highlighting the key achievements and developments from the first half of 2026. I will then hand over to Masato, who will provide an update on PDRadiopharma's progress during the first half of the year. Following these business updates, I will provide a brief review of our financial performance for the period.
I will then invite Catherine, Jun, and Kodo to briefly introduce themselves and share their perspectives as they join the leadership team at this exciting stage of the company's evolution. Kodo will then provide a brief progress update of our sustainability efforts and initiatives before I wrap up with a closing remark, and before we open the line for a question and answer session. With that, let me begin with an update on the business and our key accomplishments during the first half of 2026. As we announced at our 2026 annual shareholders meeting in March, PeptiDream is embarking on an exciting new chapter in its history. We have evolved from a university startup 20 years ago into a global discovery company. 2026 marks the next step in that journey, becoming a global discovery and development company.
This represents an important milestone on our path toward realizing our long-term vision of becoming a leading global biopharmaceutical company. To successfully execute this next phase, we are focused on three strategic priorities. First is expanding and advancing our clinical stage pipeline. Clinical programs are the primary driver of future revenue growth and corporate value creation. As such, we are focused on increasing the overall number of programs in clinical development, providing more opportunities for products to reach the market and ultimately benefit patients. Importantly, with the recent announcement that our wholly-owned CA9 targeted radiopharmaceutical program has entered a phase I study in the United States, we will continue this trend and advance select wholly-owned high-value programs into clinical development ourselves. This approach complements the outstanding development efforts of our partners, while enabling us to unlock additional clinical opportunities and create greater long-term value for shareholders.
Second, maintaining a strong focus on discovery and asset creation across our five core therapeutic areas, where macrocyclic peptides offer significant competitive advantages. Our objective is to build and sustain a robust pipeline of preclinical and clinical programs across these five core areas, both through partnerships and through internal efforts. By continuously generating high-quality development candidates, we can create a steady flow of programs entering clinical development and support sustained growth of our clinical pipeline for many years to come. In addition, these assets provide opportunities for new collaborations, licensing transactions, and strategic partnerships, allowing for revenue generation opportunities that can be reinvested to further strengthen our pipeline. Third, maintaining financial discipline. We will continue to maximize revenue opportunities from our existing collaborations and partnerships while pursuing new partnerships, licensing transactions, and other business development opportunities alongside the continued growth of PDRadiopharma.
We intend to reinvest these profits into sustaining our asset creation engine, maintaining a robust preclinical pipeline, and advancing select high-value clinical programs. By balancing our R&D investments with annual revenue and profitability, we aim to drive sustainable long-term value creation. Supported by a deeper and more experienced management team, these three priorities form the foundation of our strategy as we transition to the next phase of PeptiDream's evolution and continue building a company capable of delivering meaningful innovation for patients, partners, and shareholders worldwide. The core value of any biotech company lies in its clinical pipeline, and our pipeline remains the primary driver of long-term value creation. Today, our revenue is primarily derived from R&D funding and milestone payments from existing collaborations, as well as upfront payments from new or expanded partnerships or other business opportunities.
While these revenue streams have enabled our growth, they can fluctuate significantly from quarter to quarter and year to year. In contrast, our Japan radiopharmaceutical business provides a more stable revenue base, supported largely by commercial products and commercial sales of marketed diagnostic products and other radiopharmaceutical-related services. Looking ahead, our objective is to continue advancing our clinical pipeline and successfully bring products to patients. As more programs reach commercialization, we expect our revenue mix to evolve from one driven primarily by partnership and licensing activity to one increasingly supported by product sales and royalties, creating a more predictable and sustainable financial foundation. To achieve this, we will remain disciplined in managing costs while reinvesting the profits generated by our business into advancing expanding our pipeline, ensuring continued innovation and long-term value creation. Our five core focus areas provide PeptiDream with a broad and diverse set of value creation opportunities.
In the radiopharmaceutical space, we have built a rapidly expanding pipeline that spans late-stage programs being developed for the Japanese market through our subsidiary, PDRadiopharma, including PSMA and ATSM programs, a growing portfolio of partner programs such as our GPC3, FAP, and HER2 programs, and our first wholly-owned radiopharmaceutical program, CA9, which entered the clinic this year. Beyond our clinical-stage portfolio, we have a rich preclinical pipeline that includes both wholly-owned programs, such as our announced claudin 18.2 and CDH3, cadherin- 3 programs, as well as partner programs with some of the industry's leading companies. These programs provide multiple opportunities to continue expanding our pipeline with high-value assets and creating future sources of growth. Importantly, these development activities are complemented by PDRadiopharma's strong commercial presence in Japan.
As a leading company with a long history in radiopharmaceuticals and diagnostic imaging, as well as growing product revenue, PDRadiopharma provides both strategic capabilities and a solid commercial foundation. Together, this combination of commercial infrastructure, partnered programs, wholly-owned assets, and a deep preclinical pipeline creates a highly diversified portfolio of opportunities, positioning us to drive sustainable growth and long-term value creation for patients and shareholders. Across our other four core focus areas, which we collectively refer to as our non-radiopharmaceutical business, we continue to make strong progress across a broad portfolio of partnered and wholly-owned peptide therapeutic programs. We have several exciting partnered programs advancing toward clinical entry, while our internal programs, including myostatin, IL-17, and others, continue to progress as we evaluate opportunities to secure the best strategic partners to maximize their value.
In our oligo PDC business, we have established collaborations with many of the industry's leading pharmaceutical companies and are advancing several promising programs toward the clinic. Interest in this area remains strong, reflecting the significant potential of our technology and approach. Within our cytotox PDC portfolio, we are making excellent progress and expect our first program to enter the clinic in the near future. We believe successful clinical advancement in this area will further strengthen partnering interest and expand future business development opportunities. Lastly, in our multifunctional peptide conjugate or MPC business, our current focus is on creating high-value assets that can support future partnering transactions and establish a leadership position in this strong emerging field. Overall, this continues to be an exciting time for macrocyclic peptide therapeutics.
Demand for innovative peptide-based medicine continues to grow, and with our broad technology platform, strong partnerships, and an expanding pipeline, we see no shortage of opportunities to create long-term value. Continuing from the previous slide, the opportunities created across our five core focus areas are all rooted in the unique strengths of macrocyclic peptides. Macrocyclic peptides combine many of the key attributes sought in ideal therapeutic modality. They can deliver the high affinity and selectivity typically associated with biologics while maintaining excellent tissue and tumor penetration, rapid clearance from non-target tissues, and the flexibility of a highly versatile and scalable platform. Together, these characteristics make macrocyclic peptides exceptionally effective delivery vehicles.
This delivery capability underpins four of our five core focus areas, whether delivering a radiopharmaceutical RI payload or a cytotoxic payload to selectively kill tumor target cells, recruiting immune cells through MPCs, or delivering oligonucleotide therapeutics to specific cells and tissues through our oligo PDCs. Each of these approaches leverages the unique ability of macrocyclic peptides to precisely deliver powerful payloads where they are needed most. Our fifth focus area in this slide, referred to as second peptide therapeutics, represents another significant opportunity. Both injectable and, more recently, oral peptide medicines have emerged as one of the most exciting areas in drug development, driven by recent clinical and approval successes. Taken together, these trends reinforce our conviction that macrocyclic peptides will continue to play an increasingly important role in the development of future therapeutics.
Few companies are as broadly positioned across this opportunity set as PeptiDream, and we believe our platform, our pipeline, and our partnerships provide a strong foundation for creating transformative medicines for patients. After seeing six programs advance into the clinic in 2025, we began fiscal year 2026 with 13 clinical stage programs. At the start of the year, we guided that we expected an additional 6- 12 programs to enter the clinic during the year, further expanding our growing clinical pipeline. The first half of 2026, we have already achieved significant progress. Already with six new programs entering clinical development. In April, our partner, Asahi Kasei Therapeutics, advanced AK1940, a selective TNF receptor 1 inhibitor into a phase I study.
In July, PeptiDream achieved a major milestone as our first wholly-owned radiopharmaceutical theranostic program, CA9 for kidney cancer, entered a phase I study in the U.S. More recently, MSD announced that a PET imaging agent originating from our collaboration has also advanced into the clinic. Just this morning, we were delighted to be able to announce that Novartis has entered the clinic with our partner RI PDC program targeting HER2. These achievements have expanded our clinical pipeline from 13 programs at the beginning of the year to 19 current programs today, allowing us to already achieve the low end of our fiscal 2026 guidance, but more importantly, demonstrate the continued productivity of our platform and partnerships.
With a growing number of late-stage preclinical assets across our five core focus areas, we are well-positioned to sustain this pace of pipeline expansion through 2027 and beyond. This slide provides an overview of our radiopharmaceutical pipeline. The arrows highlight the five programs that newly entered the clinic during the first half of fiscal year 2026. On our non-RI pipeline, this slide provides an overview of our non-RI peptide pipeline. The arrow highlights the addition of the AKT program that newly entered the clinic during the first half of fiscal year 2026.
We have already seen a number of important clinical development milestones during the first half of fiscal year 2026, including the clinical advances I highlighted earlier from our collaborations with Asahi Kasei Therapeutics, MSD, and Novartis, as well as the advancement of our first wholly-owned CA9 program. In addition to those achievements, the year began with a clinical candidate announcement from our partnership with Johnson & Johnson, continuing to highlight the productivity of our partnered portfolio. Also, in June, our second wholly-owned radiopharmaceutical program targeting claudin 18.2, entered a phase 0 human imaging study in collaboration with the wonderful folks at the National Cancer Center, Japan. This is an important milestone for the program, enabling us to establish proof of concept in humans and supporting the program's potential advancement into a future phase I clinical development study.
Masato will discuss our therapeutic and diagnostic PSMA program in more detail during the PDRadiopharma update. With that, I would now like to turn the call over to Masato. Masato, please.
I'm Masato Murakami, President of PDRadiopharma. I will now provide an update on PDRadiopharma first half progress. This slide summarizes PDRadiopharma's value creation through three elements: the commercial engine, value catalyst, and strategic enablers. The commercial engine is our existing product revenue base. Product revenue grew 30% year-on-year in the first half, strengthening our durable commercial foundation. The value catalysts are late-stage assets with the potential to become future product revenue, including the PSMA diagnostic and therapeutic programs, and 64Cu-ATSM. The strategic enabler on the right is the broader environment supporting commercialization. National policy recognition increasingly addresses development, manufacturing supply, and healthcare infrastructure for RI-based medicines. PDRadiopharma's strength is having both a growing commercial base and integrated regulatory manufacturing supply and commercial capabilities in Japan. I will explain these with the following three slides.
I will next discuss PET products, which continue to strengthen our commercial revenue base. PET product revenue grew 30% year-on-year in the first half of FY 2026. The key growth drivers were AMYViD and FDG. For AMYViD, utilization expanded with the amyloid treatment market. FDG also continued to grow, supported by flexible dosing. Overall PET growth strengthened PDRadiopharma's commercial foundation while supporting continued investment in late-stage programs. We'll continue to build on growth in PET products and our broad portfolio of marketed radiopharmaceuticals to support sustainable growth across the radiopharmaceutical business. Next, I will discuss late-stage assets that we are advancing toward potential product revenue in Japan. In prostate cancer, we are establishing an integrated diagnostics and therapeutics PSMA franchise in Japan. On the left 64Cu-PSMA-I&T is a PSMA-targeted PET diagnostic agent.
It is intended to support the recurrence detection, metastatic disease assessment, and patient selection for PSMA-targeted therapy. Patient dosing was completed in June 2026, and a data readout is expected in the second half FY 2026. This is a near-term catalyst for us, followed by a planned NDA in FY 2027. In the middle, 177Lu-PSMA-I&T. This is a PSMA-targeted therapeutic agent for patients with post ARSI pre-taxane metastatic castration-resistant prostate cancer, or mCRPC. The registration study is underway following first patient dosing in February 2026. An NDA is planned for FY 2029. Together, the diagnostic and therapeutic programs are designed to connect patient selection with PSMA-targeted therapy through an integrated PSMA franchise. The PSMA-I&T programs are partnered with Kyorin Pharmaceutical. On the right 64Cu-ATSM is a therapeutic candidate for recurrent malignant glioma. Recurrent malignant glioma has limited treatment options and significant unmet medical need.
First patient dosing in phase III registrational study began in June 2024, and the study is currently underway. An NDA is planned for FY 2028. This program has been co-developed under the partnership with LinqMed. These development programs are subject to a successful clinical development, regulatory approval, and launch. PDRadiopharma has regulatory manufacturing supply and commercial capabilities in Japan. By leveraging these capabilities, PDRadiopharma is positioned to convert successful clinical assets into future product revenue in Japan. At the end, in my presentation, I will discuss the policy environment surrounding radiopharmaceuticals in Japan. In the Japan growth strategy, drug discovery and advanced healthcare is identified as one of the 17 strategic sectors, and is positioned as national priority for Japan's long-term competitiveness.
In the basic policies for economic and fiscal management and structure reform 2026, RI-based medicines were highlighted as a priority area in drug discovery and advanced healthcare, including the promotion of research, development, and production. In addition, the Japan Atomic Energy Commission of the Cabinet Office established a dedicated expert panel in April 2026. These policy developments explicitly address RI-based medicines, including RI supply chain resilience, domestic manufacturing capabilities, treatment capacity, and hospital infrastructure and coordination across the path to adoption. Policy recognition is positive while implementation across supply manufacturing and healthcare delivery remains essential. PDRadiopharma will closely monitor policy implementation while steadily preparing manufacturing supply regularly and commercial capabilities for future proprietary and partnered radiopharmaceutical launches. We will continue to ensure stable supply of existing products, advance late-stage assets, and deliver new diagnostic and therapeutic options to patients.
Through these efforts, we aim to contribute to patients while supporting sustainable growth for PDRadiopharma. That concludes PDRadiopharma update.
Right. Thank you, Masato. For the first half of fiscal year 2026, we reported total revenue of JPY 9.2 billion, an operating loss of JPY 2.5 billion, and earnings per share of JPY - 15.51. These results were in line with our expectations and reflected the planned investments we are making to support the continued growth of our pipeline and business. There were no significant surprises during the reporting period. Turning to our outlook, we are reaffirming that our fiscal year 2026 guidance remains unchanged with expected revenue of JPY 32 billion and a return to profitability. For our drug discovery and development business, we continue to see strong interest from companies wanting to partner or expand existing partnerships with us.
We have multiple active discussions underway, and therefore, we remain confident in our ability to achieve our JPY 15 billion revenue target for the fiscal year. Within our Radiopharma business, performance at PDRadiopharma has been extremely solid, particularly for our PET product portfolio, as Masato highlighted earlier. Based on this performance to date and expected trends through the remainder of the year, we remain confident in achieving our JPY 17 billion revenue target. As we described in February, we introduced a new category we refer to as plus alpha, which represents potential partnering, licensing, and other strategic transactions that were not included in our fiscal 2026 guidance assumptions. Importantly, none of our major wholly-owned programs were incorporated into our base case forecast for fiscal 2026.
In part, reflecting the challenges of predicting the timing of any license transaction, but also our strong commitment to securing the right partner for each asset to maximize its long-term value. We recognize the significant shareholder interest surrounding our oral myostatin and oral IL-17 programs. We continue to evaluate a range of partnering opportunities for these programs. While our priority remains finding the right partner rather than simply completing a transaction, I am confident we will secure strong partners for both programs and maximize their long-term value. Importantly, we remain in a very strong cost position to execute our strategy and support the continued expansion of our pipeline. We expect that position to strengthen further as we complete additional partnering deals this year and into 2027.
As planned, we have increased our R&D investment in 2026, primarily to support the clinical advancement of our CA9, CLDN18.2, and PSMA programs, as well as continued development activities related to our oral IL-17, oral myostatin, and MPC platforms. At the same time, we remain committed to financial discipline. While we will continue to invest in our highest value opportunities, we intend to carefully balance our annual R&D expenditures against revenue generation and profitability objectives, ensuring we maintain a strong financial foundation while advancing our long-term growth strategy. Additionally, both the Tonomachi and Kawasaki capital projects continue to advance. We expect to fund these investments primarily through long-term bank loans, while also pursuing available government incentive and support programs. With our strong cash position and anticipated future business development revenues, we remain well-positioned to execute these projects while maintaining our financial discipline.
I would like to briefly highlight the leadership changes we announced earlier this year. On July 1st, we welcomed Catherine Ohura, Jun Kono, and Kodo Shikata as executive vice presidents. This follows the announcement on April 1st, in which we promoted six key functional leaders to vice president roles. Building a deep, experienced, and scalable management team has been a key priority for both myself and PeptiDream's board of directors. As PeptiDream continues to grow and evolve, we will continue to strengthen our leadership organization and add exceptional talent where needed to support our long-term ambitions. With that, I would like to invite each of our new EVPs to briefly introduce themselves. Following these introductions, Kodo will provide an update on our sustainability initiatives. Cathy, if you would be so kind as to start us off.
Thank you very much. Good afternoon, everyone. It is a pleasure to meet you. My name is Catherine Ohura. I joined PeptiDream in July as EVP responsible for operations. I began my pharmaceutical career in the U.S. after joining Kyowa Kirin's U.S. operations in their early stage. Over 13 years, I gained hands-on experience across drug development, organizational build-out, and business operations. I then worked at Bristol Myers Squibb, where I led large-scale global organizations and contributed across both R&D and commercial organizations, primarily through project management and operational leadership. I later served in senior leadership roles, including CEO of the GHIT Fund, representative director and general manager of Labcorp Drug Development Japan, and representative director and general manager for Illumina Japan, leading business growth and organizational transformation in Japan.
Since joining PeptiDream, I have been impressed not only by the potential of PDPS and the breadth of our pipeline, but also by the strong commitment of our employees to changing the world through next generation medicines. I believe transformation begins with believing in bold ideas. Steve Jobs said that only those who truly believe they can change the world are the ones who actually do, which is a conviction that I have long held close to me, and I believe the future PeptiDream is working toward lies beyond exactly that kind of challenge. From the operations function, I look forward to supporting PeptiDream's continued growth and helping deliver new value and possibilities to patients worldwide. Thank you very much. Next, we'd like to invite Kono-san for his introduction.
Good afternoon, everyone. Thank you for joining us. My name is Jun Kono. I recently joined PeptiDream as EVP, responsible for corporate strategy. Prior to joining PeptiDream, I spent my career at AstraZeneca, where I held leadership positions across commercial operations, corporate strategy, and business development. Working in Japan, the U.S., and Europe, and leading global business development, M&A, and licensing activities, I have focused on translating scientific innovation into meaningful value for patients and sustainable value for shareholders. Since joining PeptiDream, I have been deeply impressed by the uniqueness and strength of the PDPS platform, as well as the exceptional talent and organizational capabilities behind it, and the highly collaborative relationship with the company that has established with partners around the world. Seeing these capabilities from inside has reinforced my conviction that macrocyclic peptides represent an increasingly important modality in drug discovery and development.
At the same time, I believe that the next phase of growth requires more than creating innovative technologies. Success will depend on our ability to advance these innovations through development and build a sustainable business around them, and ultimately deliver new medicines to patients. My goal at PeptiDream is to help ensure that the innovation engine powered by PDPS translates into long-term growth and enhanced shareholder value. By rigorously prioritizing our portfolio, maximizing the value of our partnerships, and strategically advancing our proprietary programs, I look forward to helping PeptiDream continue its evolution as a leading global biotech company, delivering transformative medicines to patients all around the world. Thank you, and I look forward to meeting many of you in the months ahead. Next, we'd like to introduce Shikata-san.
Thank you, Kono-san. I'm Kodo Shikata, a newly- appointed Executive Vice President, People and Culture, and responsible for sustainability in addition to human resources in organizational areas. I have spent my career in the pharmaceutical industry across both drug discovery research and people and organizational management. My experience in new drug discovery and in supporting management through human resources and organizational initiatives forms the foundation of my current roles. Through my experience in R&D, I learned that innovative outcomes are not created by excellent science alone, but by the people and organizational capabilities that make that science possible. I believe people are the source of corporate value, and the role of people and culture is to maximize that value. PeptiDream is taking on the challenge of creating next generation medicines through world-class science based on PDPS. Our competitiveness is supported by the expertise and a spirit of challenge of each employee.
In my role overseeing people and culture and sustainability, I will contribute to sustainable growth and long-term shareholder value creation by maximizing human capital and enhancing organizational and governance capabilities. I will now move on to our sustainability initiative explanation. On this slide, I will explain our recent sustainability initiatives and key external recognition. PeptiDream aims to contribute to solving social issues through its mission of creating next generation medicines while also achieving sustainable value creation. We position sustainability as the foundation of our business growth and long-term corporate value. On the left are our main initiatives since FY 2025. In governance, we are enhancing corporate governance with a new leadership structure. In climate and water, PDRadiopharma Chiba plant will switch to 100% renewable energy for its electricity this fiscal year, and 80% of group-wide electricity consumption is powered by renewable energy.
In addition, we have set a goal of reducing water consumption by 1% annually through 2030 and are promoting the proper use and conservation of water resources. In people, we are creating an environment where diverse talent can thrive. One example is para-athlete Tsukimura, who belongs to our team and captured the gold medal at the 2025 Wheelchair Rugby Asia-Oceania Championship as a member of the Japan national team. On the right is external recognition driven by our ESG performance. PeptiDream was selected for the CDP 2025 Climate A list, the highest rating for climate-related disclosure and performance. We have also continued to be selected for major ESG initiatives, including six consecutive years in the FTSE JPX Blossom Japan Index and five consecutive years in the FTSE JPX Blossom Japan Sector-Relative Index.
In addition, PeptiDream has been recognized by indices evaluating environmental disclosure and carbon efficiency, as well as gender diversity. We will continue to advance initiatives in governance, climate, water, and people using sustainability and business growth to strengthen the foundation for sustainable value creation. That concludes my explanation. Thank you very much. Reid-s an, please.
Thank you. Overall, I am exceptionally pleased with our progress and remain extremely confident in our future outlook. Our clinical pipeline is rapidly expanding, and our business development opportunities are numerous and stronger than ever. We are extremely well-positioned to execute on the strategies outlined today and deliver to patients next-generation macrocyclic peptide-based diagnostics and therapeutics. With that, I will conclude today's presentation and turn to the Q&A session, where I would be happy to take any questions. Thank you.