Aktis Oncology — Q3 2026 Earnings Summary

Financial Performance:

• Cash, cash equivalents, and marketable securities totaled $492.9 million as of September 30, 2026, an increase from $226.8 million as of December 31, 2025, driven by net proceeds from the January 2026 IPO offset by operating cash usage.
• Collaboration revenue was $3.9 million for the quarter ended September 30, 2026, compared to $1.6 million in the prior-year period, a $2.3 million increase attributed to the advancement of the research collaboration with Eli Lilly and Company.
• Research and development expenses were $32.1 million for the quarter, up from $16.5 million in the comparable prior-year period; the $15.6 million increase was driven by clinical trial advancement for AKY-1189 and AKY-2519 and increased headcount in clinical development and manufacturing.
• General and administrative expenses were $6.5 million for the quarter, up from $3.3 million in the prior-year period; the $3.2 million increase was due to increased headcount and activities associated with operating as a public company.
• Net loss was $29.9 million for the quarter ended September 30, 2026, compared to $15.5 million in the prior-year period; the $14.4 million increase was primarily driven by higher operating expenses, partially offset by increased collaboration revenue and interest income.
• Total operating expenses for the nine months ended September 30, 2026, were $96.9 million compared to $61.9 million in the prior-year period.
• Total assets were $532.5 million as of September 30, 2026, compared to $264.9 million as of December 31, 2025.
• Total liabilities were $73.6 million as of September 30, 2026, compared to $77.6 million as of December 31, 2025.
• Total stockholders' equity and redeemable convertible preferred stock were $458.9 million as of September 30, 2026, compared to $187.3 million as of December 31, 2025.

Guidance and Future Outlook:

• Preliminary data for AKY-1189 is expected in the first quarter of 2027.
• Preliminary data for AKY-2519 is expected in 2027.
• Two early pipeline programs are tracking toward development candidate nomination and commencement of IND-enabling activities in the first quarter of 2027.
• The Company expects to expand drug supply to include its in-house GMP facility to support ongoing clinical trials in the first half of 2027.
• Cash, cash equivalents, and marketable securities as of September 30, 2026, are expected to fund the Company's operating plan into 2029.

Business Segments and Product Lines:

• AKY-1189: A miniprotein radioconjugate targeting Nectin-4 for locally advanced or metastatic urothelial cancer (mUC) and breast cancer. Dose escalation is ongoing in the Phase 1b NECTINIUM-2 trial, and backfill cohorts were initiated at the 6 MBq dose level to evaluate up to 30 patients.
• AKY-2519: A miniprotein radioconjugate targeting B7-H3 for prostate, lung, and other solid tumors.
  • The Phase 1b BActinium-2 trial was initiated to evaluate AKY-2519 in non-small cell lung cancer (NSCLC) and other B7-H3 expressing solid tumors.
  • Dose escalation continues in the Phase 1b BActinium-1 trial for metastatic castration-resistant prostate cancer (mCRPC), including PLUVICTO-naïve and PLUVICTO-experienced patients.
  • Backfill cohorts were initiated at the 9 MBq dose level in the BActinium-1 trial for both mCRPC patient populations to evaluate up to 30 patients per cohort.
• Manufacturing: Aktis began manufacturing drug product in its in-house GMP facility at 17 Drydock in Boston as part of a hybrid sourcing strategy and intends to amend INDs to include this facility.

Market and Competitive Landscape:

• The Company is expanding the targeted radiopharmaceutical modality to more targets (Nectin-4 and B7-H3), broader indications, and larger patient populations.
• Aktis has a discovery collaboration with Eli Lilly and Company to leverage its miniprotein platform to develop novel radioconjugates outside of its proprietary pipeline.
• The Company's proprietary platform is designed to maximize anticancer activity through high tumor penetration and internalization while rapidly clearing from normal organs, and enables visualization of target engagement prior to therapeutic exposure.

Risks and Challenges:

• Forward-looking statements regarding clinical trial timing, results, and regulatory approvals are subject to risks including the commencement and completion of trials, limited operating history, ability to generate positive clinical results, and changes in laws and regulations.
• Actual results could differ materially from forward-looking statements due to competitive pressures, business interruptions, and other risks inherent in clinical development.

Management Commentary and Tone:

• Matthew Roden, Ph.D., President and CEO, stated the Company is on a trajectory to redefine radiopharmaceuticals as a major pillar of cancer treatment and highlighted "tremendous progress operationalizing this vision" in the third quarter.
• Management emphasized the ability to execute rapidly with quality across multiple clinical trials, noting the initiation of three trials across two novel targets positions the Company for a "data-rich 2027."
• The CEO highlighted the robust end-to-end supply chain supported by multiple contract manufacturing organizations and isotope suppliers, and the successful operationalization of the in-house GMP facility to support potential Phase 3 trials and commercial supply in a capital-efficient manner.

Other Key Points:

• The Company completed an initial public offering in January 2026, which generated the net proceeds that increased the cash position.
• Three clinical trials are currently underway in the U.S. across two novel targets: Nectin-4 (AKY-1189) and B7-H3 (AKY-2519).
• The NECTINIUM-2, BActinium-1, and BActinium-2 trials are all Phase 1b, multicenter, open-label studies conducted in the U.S. with identifiers NCT07020117, NCT07581184, and NCT07887971, respectively.
• The Company plans to amend INDs for AKY-2519 and AKY-1189 to include the in-house facility as a manufacturer of clinical supply.