Obsidian Therapeutics — Third Quarter 2026 Earnings Summary

Financial Performance:

• Net loss for the three months ended September 30, 2026, was $50.7 million ($1.23 per basic and diluted share), compared to a net loss of $28.5 million for the same period in 2025.
• Research and development expenses were $27.5 million for the three months ended September 30, 2026, an increase from $25.0 million in the prior year period.
• General and administrative expenses were $10.3 million for the three months ended September 30, 2026, compared to $4.6 million in the prior year period.
• Acquired in-process research and development expense associated with the Galera transaction was $15.1 million for the three months ended September 30, 2026, with no comparable expense in the prior year.
• Total operating expenses were $52.9 million for the three months ended September 30, 2026, versus $29.6 million in the prior year period.
• Cash, cash equivalents, and marketable securities totaled $324.4 million as of September 30, 2026, up from $80.5 million as of December 31, 2025.
• Interest and other income was $2.3 million for the three months ended September 30, 2026, compared to $1.2 million in the prior year period.

Guidance and Future Outlook:

• Enrollment in the registration-enabling cohort of the Phase 1/2 Agni-01 study is expected to be completed by the end of the first quarter of 2027.
• Topline data from the registration-enabling cohort is expected by year-end 2027.
• Phase 1 data for amsoki-cel in non-small cell lung cancer (NSCLC) is expected in the first half of 2027.
• The company expects its current cash, cash equivalents, and marketable securities to support planned operations into the second half of 2028.

Business Segments and Product Lines:

• Amsoki-cel (amsokigene autoleucel): Updated efficacy and pooled safety data were presented at the 41st Annual SITC Meeting for patients with immune checkpoint inhibitor (ICI)-resistant advanced melanoma.
  • In the efficacy set (n=15), the objective response rate (ORR) was 67%, including 2 confirmed complete responses and 8 confirmed partial responses.
  • Median progression-free survival (PFS) was 8.3 months.
  • Median duration of response (mDOR) was not reached at a median study follow-up of 14.3 months.
  • 33% of all treated patients (5/15) remained in deep, ongoing response at the 12-month post-infusion landmark.
  • Pooled safety data across 37 patients showed no dose-limiting toxicities, treatment-related mortality, ICANS, or ICU transfers.
• Agni-01 Study: Enrollment in the single-arm registration-enabling cohort for ICI-resistant advanced melanoma began in August 2026. The study is a multicenter Phase 1/2 trial designed to evaluate safety and efficacy at the recommended phase 2 dose.
• NSCLC Program: The company is investigating amsoki-cel in patients with non-small cell lung cancer within the Agni-01 trial.
• Galera Transaction: Obsidian completed its transaction with Galera Therapeutics, resulting in the acquisition of in-process research and development assets.

Market and Competitive Landscape:

• The company is developing engineered tumor-infiltrating lymphocyte (TIL) cell therapies using its proprietary cytoDRiVE® technology, which regulates protein function using FDA-approved small-molecule drugs.
• Amsoki-cel is being evaluated as a potential therapeutic option for advanced unresectable or metastatic melanoma and other solid tumors.

Risks and Challenges:

• Forward-looking statements highlight risks including the ability to advance amsoki-cel through clinical development and obtain regulatory approval.
• Risks include the possibility that clinical study results may differ from reported data, the timing of enrollment and data readouts, and the need for substantial additional funds to complete development and commercialization.
• The company faces risks related to dependence on third parties for clinical trials and manufacturing, as well as the ability to attract and retain key personnel and protect intellectual property.
• Actual results may differ materially from expectations due to regulatory developments, competition, and other uncertainties.

Management Commentary and Tone:

• CEO Madan Jagasia, M.D., described 2026 as a "transformative year," citing the completion of the Galera transaction, the $350 million financing, and the debut on Nasdaq.
• Management expressed strong belief in the amsoki-cel program, noting that updated data strengthens confidence in the program's consistent, favorable safety profile and encouraging clinical activity.
• The company remains on track to complete enrollment in the registration-enabling cohort by the end of Q1 2027 and report topline data by year-end 2027.

Other Key Points:

• Obsidian completed an oversubscribed private placement raising $350 million in gross proceeds.
• The company began trading on Nasdaq on August 4, 2026, under the ticker symbol "OBX."
• Mark Reisenauer was appointed to the Board of Directors in November 2026, bringing over 30 years of experience in oncology commercialization.
• A publication summarizing safety and efficacy data from the FIH and ongoing Agni-01 studies was published in Nature Medicine.
• Total assets increased to $340.7 million as of September 30, 2026, from $88.6 million as of December 31, 2025.
• Total stockholders' equity turned positive at $320.6 million as of September 30, 2026, compared to a deficit of $266.0 million as of December 31, 2025.