Aug 10, 2026, 7:00 AM ETHealthcare

Oruka Therapeutics — Second Quarter 2026 Earnings Summary

ORKAORUKA THERAPEUTICS INC

Financial Performance

Net loss was $41.2 million for the second quarter of 2026, compared to $24.6 million in the second quarter of 2025.
Research and development expenses were $43.3 million for the second quarter of 2026, an increase from $24.1 million in the same period in 2025.
General and administrative expenses were $6.9 million for the second quarter of 2026, compared to $4.3 million in the second quarter of 2025.
Other income, net was $8.9 million for the second quarter of 2026, compared to $3.9 million in the second quarter of 2025, driven by interest earned.
As of June 30, 2026, cash, cash equivalents, and marketable securities totaled $1.1 billion.
Total assets were $1.14 billion as of June 30, 2026, compared to $488.6 million as of December 31, 2025.
Total liabilities were $24.8 million as of June 30, 2026, compared to $16.7 million as of December 31, 2025.
Stockholders' equity was $1.11 billion as of June 30, 2026, compared to $471.9 million as of December 31, 2025.
Net loss per share attributable to common stockholders was $0.55 for the second quarter of 2026, compared to $0.46 in the second quarter of 2025.

EVERLAST-A Week 28 data is expected at the end of the third quarter of 2026, with 52-week data for all participants expected in December 2026.
EVERLAST-B is fully enrolled ahead of schedule, with Week 16 data now expected in the fourth quarter of 2026.
A Phase 3 program for ORKA-001 is expected to begin in the first half of 2027.
ORCA-SURGE Week 16 data is accelerated and now expected in the first quarter of 2027.
ORKA-004 is anticipated to enter the clinic in the fourth quarter of 2026, with Phase 2 combination studies planned to begin in 2027.
The Company expects its cash position to fund operations through an anticipated BLA filing for ORKA-001 and continued development of ORKA-002.

ORKA-001: In the April 2026 EVERLAST-A Phase 2a trial for moderate-to-severe plaque psoriasis, 63.5% (40 of 63) of participants achieved PASI 100 at Week 16; 83% achieved PASI 90 and 84% achieved IGA 0/1 at Week 16. The drug was well tolerated with a safety profile similar to placebo.
ORKA-002: The Company initiated ORCA-SPLASH, a Phase 2 trial in moderate-to-severe hidradenitis suppurativa involving approximately 160 participants in the US and Canada, with a primary endpoint of HiSCR75 at Week 16.
ORKA-004: A novel half-life extended monoclonal antibody targeting TL1A is planned for subcutaneous administration and is expected to enter the clinic in 4Q 2026.
Everlast-B: Completed enrollment of 187 subjects in the second quarter of 2026.

The Company is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases, including plaque psoriasis and hidradenitis suppurativa.
The Company aims to achieve high rates of disease clearance with dosing as infrequently as once or twice a year.
The Company plans to pursue ORKA-004 in combination with ORKA-001 and ORKA-002.

Forward-looking statements involve risks and uncertainties, including uncertainties regarding clinical study design, enrollment, conduct, timing, progress, and results.
Actual results may differ materially from projected results due to factors described in the Company's SEC filings, including the Annual Report on Form 10-K and Quarterly Reports on Form 10-Q.
Risks include the potential for clinical trial results to be different from expectations, regulatory delays, and assumptions regarding the therapeutic potential and safety of the pipeline.

CEO Lawrence Klein, PhD, stated that the second quarter and recent months were "highly productive" as the company advanced co-lead programs toward important readouts.
Management expressed confidence in executing their strategy to establish ORKA-001 and ORKA-002 as potentially best-in-class options across psoriatic disease and beyond.
Management highlighted the expectation of multiple significant clinical catalysts over the coming quarters.

In April 2026, the Company announced the pricing of an upsized $700 million public offering.
In May 2026, Oruka amended its IL-23 license agreement with Paragon Therapeutics to include all therapeutic areas, specifically adding inflammatory bowel disease (IBD), subject to timing restrictions on initiating clinical trials.
The increase in R&D expenses was primarily related to additional clinical trials, a non-refundable upfront payment to Halozyme, and higher employee compensation including stock-based compensation.
The increase in G&A expenses was primarily related to employee compensation, stock-based compensation, and costs associated with operating as a growing public company.
Total operating expenses for the six months ended June 30, 2026, were $86.5 million, compared to $53.5 million for the same period in 2025.
Net loss for the six months ended June 30, 2026, was $73.0 million, compared to $45.6 million for the same period in 2025.