Obsidian's first quarter as a public company: $324.4M cash, a widening loss and a 2027 readout

The quarter in numbers

Obsidian Therapeutics is a clinical-stage company with no revenue line in its statement of operations, so its third-quarter story is about spending, cash and capital structure. Net loss for the three months ended September 30, 2026 was $50.7 million, or $1.23 per basic and diluted share. That compares with a net loss of about $28.5 million in the third quarter of 2025, based on the release's table.

Total operating expenses were $52.9 million, against $29.6 million a year earlier, an increase of roughly 79%. Interest and other income was $2.3 million, up from $1.2 million, which offset only a small part of the higher spending. For the nine months, net loss was $96.2 million versus $80.4 million in the prior-year period.

What drove costs: Galera, G&A and a modest R&D rise

Three items explain the increase. First, Obsidian booked $15.1 million of acquired in-process R&D tied to the Galera Therapeutics transaction, with no equivalent charge in the prior-year quarter. Excluding that item, operating expenses were about $37.9 million, still above last year's $29.6 million.

Second, general and administrative expense rose to $10.3 million from $4.6 million, more than double. The release does not break out the causes. The timing is consistent with the company's transition to a Nasdaq-listed entity, which the company said happened on August 4, 2026, but the document does not make that link explicit.

Third, R&D was $27.5 million versus $25.0 million, up about 10%. On a nine-month basis R&D was actually lower, at $64.8 million versus $69.1 million, so the quarter's R&D increase has not yet shown up as a year-to-date trend.

Balance sheet and runway

The financing changed the balance sheet. Cash, cash equivalents and marketable securities stood at $324.4 million at September 30, 2026, up from $80.5 million at December 31, 2025. The company said it closed an oversubscribed private placement of $350 million in gross proceeds during the quarter. Total assets rose to $340.7 million from $88.6 million.

The $338.0 million of convertible preferred stock on the December 2025 balance sheet is gone, and total stockholders' equity is $320.6 million versus a deficit of $266.0 million. Total liabilities were modest at $20.2 million. The company said its cash will support planned operations into the second half of 2028. That runway covers both the expected 2027 topline readout and a period beyond it, but the release gives no spending guidance behind the estimate.

Clinical data: encouraging, but small and single-arm

The pipeline is effectively one asset: amsoki-cel (formerly OBX-115), an engineered TIL cell therapy armored with regulatable membrane-bound IL-15, in immune checkpoint inhibitor-resistant advanced melanoma. At SITC, the company presented efficacy data from the single-arm Phase 1/2 Agni-01 study in 15 patients treated at the recommended Phase 2 dose, with a September 25, 2026 data cutoff.

The release reports a 67% ORR per RECIST v1.1 (10 of 15), made up of 2 confirmed complete responses and 8 confirmed partial responses. Median PFS was 8.3 months and median duration of response was not reached at a median follow-up of 14.3 months. Five of the 10 responses were ongoing, and 5 of 15 patients (33%) remained in deep, ongoing response at the 12-month post-infusion landmark.

On safety, pooled data from 37 patients across the Phase 1 first-in-human study and Agni-01, as of a May 5, 2026 cutoff, showed no dose-limiting toxicities, treatment-related mortality, ICANS or ICU transfers. One Grade 3 cytokine release syndrome event was reported. The efficacy and safety datasets use different cutoffs and patient counts, and the efficacy set is only 15 patients. The company also noted a Nature Medicine publication of pooled Phase 1 and 1/2 data as of May 5, 2026.

Regulatory path and catalysts

The key milestone is the registration-enabling cohort of Agni-01. The company said enrollment began in August 2026, is expected to complete by the end of the first quarter of 2027, and will produce topline data by year-end 2027. The cohort is single-arm, with ORR per RECIST v1.1 assessed by blinded independent central review as the primary endpoint. The release does not discuss specific FDA interactions beyond a general reference to regulatory agencies.

A second catalyst is nearer: NSCLC Phase 1 data from Agni-01 are expected in the first half of 2027. Separately, Obsidian appointed Mark Reisenauer to its board in November 2026. The company highlighted his more than 30 years of oncology commercialization and launch experience, which signals attention to eventual commercial readiness.

What to watch next

Watch whether G&A settles near the third-quarter level or falls back, and how R&D moves as the registration-enabling cohort enrolls, since runway into 2H 2028 depends on the pace of spending. Also watch for any update to the end-of-Q1 2027 enrollment target, the first-half 2027 NSCLC data, and whether the ORR holds up in a larger cohort than the 15 patients reported so far. The company's own risk factors flag that updated Agni-01 data may differ from results reported to date, and that Obsidian depends on third parties for trials and manufacturing.