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• Corporate Overview and Value Drivers

  • Employee count has increased slightly, with hiring progressing in R&D and other departments.
  • The two core sources of corporate value are: 1) the lead candidate CBP501, an immunological firelighter that completed Phase 2 with promising data and is currently preparing for Phase 3 application, developed via an in-house pipeline strategy; 2) a structured pipeline of follow-on candidates including CBT005 and CBS9106 with a system for continuous generation of new drug candidates.
  • Management's stated strategy to increase corporate value is: 1) steadily advance CBP501 Phase 3 trial initiation application; 2) continue IR activities to draw investor attention to corporate value; 3) prioritize securing a sustainable funding structure aligned with development progress.

• CBP501 (Lead Pipeline) Development Progress

  • Mechanism of action: CBP501 converts "immune cold" cancers (such as pancreatic cancer, which lack infiltrating CD8 T cells and do not respond to immune checkpoint inhibitors) into "immune hot" cancers. When combined with cisplatin and an immune checkpoint inhibitor, CBP501 induces immunogenic cell death of cancer cells to help CD8 T cells infiltrate tumors, and directly suppresses cytokine production by immunosuppressive macrophages, creating a synergistic effect with immune checkpoint inhibitors.
  • Phase 2 trial results: Both the 25mg CBP501 and 16mg CBP501 three-drug combination (CBP501 + cisplatin + nivolumab) arms delivered good results. As a third-line treatment for metastatic pancreatic cancer, the combination had manageable safety and delivered clinically meaningful improvement and durable responses in 3-month progression-free survival, progression-free survival, and overall survival. The results matched the long-term survival profile that management targeted in 2015, and the recommended dose arm (25mg CBP501) demonstrated the best efficacy.
  • European Phase 3 preparation status: Canvas is continuing preparation and application for a European Phase 3 trial. Preparations for rapid initiation after approval, including contract negotiations across multiple European countries and trial sites, are progressing aggressively. If issues beyond timing derail the European Phase 3, Canvas has a backup plan: initiation approval for a US Phase 2b trial is already obtained and initial preparations are complete, so the company can pivot to this pathway if needed. No indicators of issues currently exist, so Canvas is proceeding with preparation for European Phase 3, and the estimated total cost of the Phase 3 trial remains unchanged from prior guidance.

• Follow-on Pipeline Status

  • CBT005: CBT005 is a second pipeline candidate, a Peptide-Drug Conjugate that also targets converting immune cold cancers to immune hot. It targets phosphatidylserine on the surface of dying cancer cells to switch tolerogenic antigen presentation to immunogenic antigen presentation, activating an immune response against cancer. Preparation for large-scale synthesis for preclinical trials is ongoing, with active evaluation of potential modifications based on issues observed in other companies' clinical trials, so the final compound may be a slightly modified version of the original candidate.
  • CBS9106: CBS9106 is a reversible XPO1 inhibitor that kills cancer cells by temporarily inhibiting XPO1, which cancer cells rely on to export tumor suppressor proteins out of the nucleus. Compared to the already approved XPO1 inhibitor XPOVIO, CBS9106 is designed to have fewer side effects, with the ability to sharply control inhibition duration, and Canvas targets best-in-class status for this candidate. All rights were returned to Canvas by Stemline in June of last year after the license agreement was terminated, and Canvas will lead further clinical development.
  • Additional candidates: Multiple additional projects are in the basic research to preclinical preparation stage.

• Recent Corporate Milestones

  • Canvas was featured in the Tokyo Stock Exchange's "Case Studies of Growth Listed Companies Evaluated by Investors", receiving high marks in 4 out of 7 evaluated categories.
  • Canvas was selected for the JPX Startup Rapid Growth 100 Index, with index inclusion scheduled to begin March 9.

• With respect to CBP501 development, the prior public target of potential new drug approval in 2027 was withdrawn in October of last year. This withdrawal only reflects delays to the trial timeline caused by timing-related uncertainty, not any materialization of non-timing-related fundamental issues; the trial is still expected to be feasible.
  • There is no change to the expected cost of the CBP501 Phase 3 trial, and Canvas has sufficient funds to cover trial initiation costs after the successful 2023 financing. No large change to expected capital demand after Phase 3 initiation is projected relative to initial estimates.
  • The key upcoming anticipated news flow is the receipt of initiation approval for the European Phase 3 trial of CBP501, which management aims to deliver as soon as possible. No change to the expected future news flow schedule is projected beyond the timing uncertainty for Phase 3 approval.
  • Canvas does not currently face an urgent need to conduct rushed funding. If the Phase 3 trial initiates earlier than expected, triggering faster cash burn, Canvas will conduct funding after positive clinical milestones to maintain shareholder value, and will prioritize approaches that minimize or avoid shareholder value dilution and share dilution when pursuing additional capital.

Canvas is a pre-revenue clinical-stage biotech company focused on oncology immunotherapy drug discovery. As of the 2026 June fiscal year second quarter, no business revenue is recorded. Total business expenses were approximately 0.6 billion yen: basic research expenses remained nearly flat year-over-year, clinical development expenses increased compared to prior years, and selling, general and administrative expenses remained at the same level year-over-year. From January 2025 to September 2025, quarterly clinical development expenses averaged approximately 0.2 billion yen, driven by manufacturing-related costs for CBP501 European Phase 3 preparation and regulatory compliance. The peak of these manufacturing-related regulatory compliance costs has passed, and clinical development expenses for the second quarter (October 2025 to December 2025) fell to just over 0.1 billion yen. Cash and cash equivalents totaled approximately 2.8 billion yen at the end of June 2025, and approximately 2.2 billion yen at the end of December 2025.

• Timing-related uncertainty for European Phase 3 initiation approval: There are uncontrollable factors (primarily regulatory interactions with EMA) that mean management cannot reliably predict when approval will be received. This is not a fundamental problem, and approval is expected to be granted eventually, but the timing cannot be confirmed.
  • While no major fundamental issues with the trial design or clinical plan have been identified to date, there is inherent uncertainty that non-timing-related fundamental issues could arise in the future.
  • If the Phase 3 trial is initiated earlier than currently expected, cash burn will accelerate, requiring additional capital raising that could result in shareholder dilution.
  • While current interactions with EMA are limited to CMC (chemistry, manufacturing, and controls) issues, with clinical design already cleared, there is still a risk that new clinical-related issues could arise in the future given the rapidly evolving state of the oncology field.

Q: Are interactions with EMA (European Medicines Agency) only related to CMC (chemistry, manufacturing, and controls)? Have any issues related to clinical development itself emerged? What is the current status of these interactions?

A: As noted, all outstanding issues to date are limited to manufacturing-related matters; the clinical trial plan has already been cleared, and there are no specific concerns related to clinical development at this time. While future clinical issues cannot be completely ruled out given the rapid evolution of the field, there is no reason for concern today. EMA interactions have taken longer than expected because moving from early-stage to late-stage development requires layered quality assurance and safety measures that were not needed for earlier trials. Canvas is currently strengthening its internal quality assurance system to meet these late-stage requirements, and has significantly expanded its quality governance framework.

Q: If manufacturing issues are causing delays, is Canvas considering transferring manufacturing to a new contract manufacturer that does not have these issues, or switching to manufacturing in Europe as a solution to resolve delays?

A: Canvas is pursuing two paths in parallel. Correcting issues at the original contract manufacturer is expected to be the fastest path, so Canvas is prioritizing this option. In parallel, Canvas is evaluating a Plan B: transferring manufacturing to a European manufacturer or a company with European manufacturing experience. While this option carries risks related to timing and technology transfer, it could increase the probability of approval if successfully completed. Canvas has been internally evaluating the risks, benefits, and tradeoffs of this option since last year. No information about changes can be disclosed publicly as it includes confidential and non-public information, which investors are asked to understand. In all cases, Canvas's core goal remains balancing the fastest possible timeline with the highest probability of success, and the company will pursue any path required to achieve this goal.

Q: Many other companies are developing immunological firelighter candidates targeting the immune hot conversion approach for pancreatic cancer. Can you provide an update on competitors' development status, and how is CBP501 classified relative to other mechanism-based categories of immunological firelighters?

A: A very large number of competitor projects are in Phase 1 and early Phase 2 development, but most of these projects do not advance past early stages and are eventually discontinued. One late-stage competitor with a large ongoing Phase 3 trial is an activated RAS inhibitor that is also developing for pancreatic cancer, and that candidate delivered good Phase 2 results so it is viewed as promising. CBP501 is not expected to directly compete with other pancreatic cancer treatments; unless a curative treatment is developed, patients will still need additional lines of therapy after earlier treatments, and the overall pool of eligible patients for third-line CBP501 treatment will actually increase if earlier treatments improve patient outcomes, which is positive for CBP501. There are countless immunotherapy targets in oncology, with many different inhibitor and activator candidates in early development. The unique characteristic of CBP501 is that it does not target a single specific molecular pathway; it works holistically. It induces immunogenic cell death to kickstart the initial immune response, then mildly suppresses all immunosuppressive cytokines produced by macrophages, rather than targeting one specific cytokine, which is the approach pursued by many Western biotech companies. Given the immune system's inherent balancing feedback mechanisms that counteract strong single-target perturbations, this holistic mild suppression is expected to deliver better efficacy than sharper single-target approaches.

Q: Is the Phase 3 trial's inclusion criteria designed to allow patients who have previously participated in clinical trials for newer therapies such as Pan-KRAS inhibitors and siRNA therapies? Does it also allow patients who have previously received ADC (antibody-drug conjugate) therapies? Is the trial open to all patients who have received at least two prior lines of therapy?

A: All patients who have received two or more prior lines of therapy are eligible, as long as a sufficient waiting period has passed after completion of the prior clinical trial or treatment. Patients who have received ADC therapy are indeed eligible for inclusion. While few patients with pancreatic cancer have received ADC to date because ADC rarely delivers meaningful efficacy for pancreatic cancer, these patients are still included in the eligibility criteria. It is correct that all patients with at least two prior lines of therapy are eligible, and the top priority remains initiating the trial as soon as possible.