ORKA Filings — Oruka Therapeutics, Inc. - FilingSpy
ORKA
Oruka Therapeutics, Inc.
A clinical-stage biotech developing longer-lasting antibody drugs for skin conditions like psoriasis, aiming for injections that may be needed only once or twice a year. Its lead candidates, ORKA-001 and ORKA-002, come from Paragon Therapeutics, a drug-discovery engine that also spawned other biotechs. The name blends Hebrew words for "skin" and "restoration," and the company went public in 2024 through a reverse merger with ARCA biopharma, trading as "ORKA."
ORKA-001 achieved 63.5% complete skin clearance in Phase 2a, and a $700M offering lifted cash to $1.1B as R&D spend rose 80%.
ORKA-001 delivered the first clinical proof-of-concept for the company, with 63.5% of patients reaching complete skin clearance in a Phase 2a trial. The net loss widened to $41.2 million as R&D expense rose 80% to $43.3 million, driven by advancing clinical trials and a $5.0 million upfront payment to Halozyme, while cash and equivalents reached $268.5 million following a $700.4 million public offering. The data de-risks the lead program, but the company is now spending over $50 million a quarter with no .
Key takeaways
ORKA-001's Phase 2a EVERLAST-A trial showed 63.5% of patients achieved , or complete skin clearance, at Week 16, providing the first clinical proof-of-concept for the lead program.
R&D expense rose 80% to $43.3 million, driven by higher contract research organization costs for ongoing trials, a $5.0 million upfront payment to Halozyme, and increased manufacturing expenses.
General and administrative expense rose 58% to $6.9 million, primarily from a $1.7 million increase in and higher headcount to support public-company operations.
Section summaries
Management's Discussion and Analysis
Net loss widened to $41.2M in Q2 2026 as R&D expense surged 80% to $43.3M, driven by clinical trial activity and a $5M Halozyme payment.
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Total operating expenses rose 76% to $50.1M, with R&D up $19.2M to $43.3M due to higher costs for ongoing trials, a $5.0M upfront payment to Halozyme, and increased manufacturing expenses.
General and administrative expenses increased 58% to $6.9M, primarily from a $1.7M rise in and higher headcount to support public company operations.
Interest income rose to $8.9 million from $3.9 million a year ago, reflecting higher cash and marketable securities balances following recent equity financings.
Cash, cash equivalents, and marketable securities totaled $1.1 billion as of June 30, 2026, bolstered by $658.3 million in net proceeds from an April 2026 public offering and $38.9 million from the .
The company expects to share Week 28 data for the EVERLAST-A trial in the third quarter of 2026 and Week 16 data for the EVERLAST-B dose-ranging trial in the fourth quarter of 2026.
What changed
The Q1 2026 filing flagged the 63.5% result from ORKA-001's EVERLAST-A trial as the first clinical proof-of-concept; this quarter confirms that data and sets expectations for Week 28 follow-up data in Q3 2026.
The $700.4 million April 2026 public offering, noted as completed in the Q1 2026 filing, closed with $658.3 million in net proceeds, lifting total cash and marketable securities to $1.1 billion.
R&D expense accelerated sharply, rising 80% compared to a 46% increase in Q1 2026, driven by the new $5.0 million Halozyme payment and higher clinical trial activity as both programs advanced.
The planned $20.0 million special cash to pre-merger stockholders and disposal of legacy assets, flagged in every filing since the merger, remains unresolved.
What to watch
Week 28 efficacy data from the ORKA-001 EVERLAST-A trial, expected in Q3 2026, to assess durability of the 63.5% result.
Week 16 data from the ORKA-001 EVERLAST-B dose-ranging trial, expected in Q4 2026, to confirm and extend the EVERLAST-A findings.
Initial clinical data from the ORKA-002 Phase 2 ORCA-Increase trial in psoriasis, which began dosing in February 2026.
Quarterly operating cash burn rate, which reached $33.1 million in Q2 2026, to gauge how the $1.1 billion cash position translates into a multi-year runway.
Interest income grew to $8.9M from $3.9M a year ago, reflecting higher cash and marketable securities balances following recent equity financings.
Cash, cash equivalents, and marketable securities totaled $1.1B as of June 30, 2026, bolstered by $658.3M in net proceeds from an April 2026 public offering and $38.9M from the ATM program.
The company expects existing cash to fund operations for at least 12 months and plans to share Week 28 data for the EVERLAST-A trial in Q3 2026 and Week 16 data for EVERLAST-B in Q4 2026.
Quantitative and Qualitative Disclosures About Market Risk
We are a smaller reporting company, as defined by Rule 12b-2 under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and in Item 10(f)(1) of Regulation S-K, and are not required to provide the information under this item. 33
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We are a smaller reporting
company, as defined by Rule 12b-2 under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and in Item
10(f)(1) of Regulation S-K, and are not required to provide the information under this item.
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From time to time, we may become involved in legal proceedings relating to claims arising from the ordinary course of business. Our management believes that there are currently no claims or actions pending against us, the ultimate disposition of which could reasonably be expecte…
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From time to time, we may
become involved in legal proceedings relating to claims arising from the ordinary course of business. Our management believes that there
are currently no claims or actions pending against us, the ultimate disposition of which could reasonably be expected to have a material
adverse effect on our results of operations, financial condition or cash flows.
ORKA-001 and ORKA-002 clinical failures, capital constraints, and IP/manufacturing dependencies are the most material risks.
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The company is substantially dependent on the success of its two most advanced programs, ORKA-001 and ORKA-002, and their clinical trials may not be successful.
As a clinical-stage company with no approved products and a history of losses, it will need to raise substantial additional capital, which may cause or require relinquishing rights.
The company relies on a sole-source relationship for the supply of ORKA-001 and ORKA-002, and disruption could negatively affect clinical development.
The company's approach using extension technologies is unproven, and failure to demonstrate a longer half-life would significantly harm clinical and commercial potential.
The company depends on licensing agreements with Paragon for its lead programs, and failure to maintain these arrangements could result in the loss of intellectual property rights.
Reliance on foreign CMOs like WuXi Biologics exposes the company to risks from the BIOSECURE Act and trade restrictions, which could force a transition to alternative providers.