Oruka Therapeutics, Inc.
For the period ended Sep 30, 2026. Filed Nov 9, 2026.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2026 · Filed Nov 9, 2026
ORKA$104.56+1.7%Stored close · as of Nov 9, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-06-30; filed 2026-08-10.
0001213900-26-087231
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-09.
0001213900-26-117518
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 100 previous paragraphs and 105 current paragraphs.
63 unchanged; 27 reworded; 11 added; 10 removed; 0 previous and 4 current paragraphs rearranged.
Tables are not compared: 27 previous and 27 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (11)
Current report
In September 2026, we announced Week 28 data for EVERLAST-A, showing that efficacy continued to deepen through Week 28, six months after the last dose of ORKA-001, with 71% of participants achieving PASI 100 and 87% achieving PASI 90. Patients who initially received placebo and crossed over blinded to ORKA-001 at Week 16 demonstrated a similar pattern of clinical response to those initially receiving ORKA-001. In this dosing arm, 40% achieved PASI 100 at Week 28 (12 weeks after dosing) compared to 43% of patients in the active arm at the equivalent timepoint. ORKA-001 continued to be well tolerated through Week 28 with a safety profile consistent with the IL-23p19 class. Two patients experienced serious adverse events, neither deemed drug related: one tibial fracture and one case of prostate adenocarcinoma in a patient with elevated prostate-specific antigen (PSA) at baseline. We expect to announce Week 52 data from EVERLAST-A in December 2026.
Current report
In October 2026, we announced Week 16 data for EVERLAST-B, showing that 61% of participants in the 600 mg ORKA-001 group achieved the primary endpoint of PASI 100, highly consistent with the Week 16 results observed in EVERLAST-A. Efficacy increased in a dose-dependent manner, with the 600 mg group outperforming both lower dose groups on complete skin clearance. The ORKA-001 600 mg group also demonstrated high response rates across secondary endpoints, including 86% of patients achieving each of PASI 90 and IGA 0/1. Through Week 16, ORKA-001 was observed as well tolerated with a safety profile consistent with the IL-23p19 class. The only TEAEs occurring in ≥5% of patients treated with ORKA-001 were upper respiratory tract infection and headache, which occurred at rates similar to those seen with approved IL-23 inhibitors. No dose-dependent trends in adverse events were observed across ORKA-001 treatment groups, and no injection-site reactions occurred in any patients who received ORKA-001. We expect to announce Week 52 data from EVERLAST-B in the second half of 2027.
Current report
Based on the results from the EVERLAST clinical program, we intend to discuss Phase 3 plans with regulatory authorities. Pending results from those discussions, we plan to initiate Phase 3 trials of ORKA-001 in moderate-to-severe PsO in the first half of 2027 with the 600 mg dose.
Current report
In December 2025, the Company exercised its exclusive option to acquire certain rights to ORKA-003, and in August 2026, it entered into the corresponding license agreement with Paragon (the “ORKA-003 License Agreement”).
Current report
Research and development expenses increased by $24.7 million, from $29.0 million for the three months ended September 30, 2025 to $53.7 million for the three months ended September 30, 2026.
Current report
General and administrative expenses increased by $3.3 million, from $5.1 million for the three months ended September 30, 2025 to $8.4 million for the three months ended September 30, 2026.
Current report
Other general and administrative expenses decreased by $0.2 million, from $1.3 million for the three months ended September 30, 2025 to $1.2 million for the three months ended September 30, 2026, primarily due to a higher allocation of shared costs to research and development, reflecting growth in our research and development headcount to support our expanding clinical programs.
Current report
Comparison of the Nine Months Ended September 30, 2026 and 2025
Current report
Research and development expenses increased by $53.1 million, from $73.0 million for the nine months ended September 30, 2025 to $126.1 million for the nine months ended September 30, 2026.
Current report
General and administrative expenses increased by $8.0 million, from $14.6 million for the nine months ended September 30, 2025 to $22.6 million for the nine months ended September 30, 2026.
Current report
Stock-based compensation expense increased by $5.7 million, from $5.4 million for the nine months ended September 30, 2025 to $11.2 million for the nine months ended September 30, 2026, primarily due to additional equity awards issued to existing employees and equity awards granted to new hires.
Removed paragraphs (10)
Previous report
In addition, we expect to initiate the ORKA-001 Phase 3 program in the first half of 2027.
Previous report
In December 2025, we entered into an additional option agreement for an antibody with Paragon and Paruka to enter into a license agreement, which we exercised in December 2025. Per the terms of this option agreement, once we enter into the corresponding license agreement, we will be required to make non-refundable milestone payments to Paragon of up to $12.0 million under the agreement upon the achievement of certain clinical development milestones, up to $10.0 million under the agreement upon the achievement of a certain regulatory milestone, as well as a low single-digit percentage royalty for antibody products beginning on the first commercial sale. As of June 30, 2026, we have not entered into a license agreement with Paragon and Paruka related to this additional option agreement.
Previous report
Research and development expenses increased by $19.2 million, from $24.1 million for the three months ended June 30, 2025 to $43.3 million for the three months ended June 30, 2026.
Previous report
General and administrative expenses increased by $2.5 million, from $4.3 million for the three months ended June 30, 2025 to $6.9 million for the three months ended June 30, 2026.
Previous report
Other general and administrative expenses remained relatively consistent year over year.
Previous report
Comparison of the Six Months Ended June 30, 2026 and 2025
Previous report
Research and development expenses increased by $28.4 million, from $44.0 million for the six months ended June 30, 2025 to $72.4 million for the six months ended June 30, 2026.
Previous report
General and administrative expenses increased by $4.6 million, from $9.5 million for the six months ended June 30, 2025 to $14.1 million for the six months ended June 30, 2026.
Previous report
Expenses related to professional and consulting services increased by $0.7 million, from $2.1 million for the six months ended June 30, 2025 to $2.8 million for the six months ended June 30, 2026, due to higher spending on legal and other professional services to support our growing operations as a public company.
Previous report
Other general and administrative expenses remained relatively consistent year over year.
Reworded paragraphs (27)
Previous wording
Since our inception, we have incurred significant losses and negative cash flows from our operations. Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of any programs we may develop. As of June 30, 2026, we had an accumulated deficit of $262.2 million. For the three and six months ended June 30, 2026, we had net losses of $41.2 million and $73.0 million, respectively, and we used net cash of $56.7 million for our operating activities during the six months ended June 30, 2026.
Current wording
Since our inception, we have incurred significant losses and negative cash flows from our operations. Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of any programs we may develop. As of September 30, 2026, we had an accumulated deficit of $312.1 million. For the three and nine months ended September 30, 2026, we had net losses of $50.0 million and $123.0 million, respectively, and we used net cash of $101.0 million for our operating activities during the nine months ended September 30, 2026.
Previous wording
We had cash, cash equivalents, and marketable securities of $1.1 billion as of June 30, 2026. In addition, in July 2026, we sold 1,499,500 shares of our common stock pursuant to our existing ATM offering program for net proceeds of $122.5 million, after deducting sales agents’ commissions. We expect that our existing cash, cash equivalents, and marketable securities will be sufficient to fund our operating plans for at least twelve months from the date of filing of this Quarterly Report. We expect to continue to incur substantial losses for the foreseeable future, and our transition to profitability will depend upon successful development, approval and commercialization of our product candidates and upon achievement of sufficient revenues to support our cost structure.
Current wording
We had cash, cash equivalents, and marketable securities of $1.2 billion as of September 30, 2026. We expect that our existing cash, cash equivalents, and marketable securities will be sufficient to fund our operating plans for at least twelve months from the date of filing of this Quarterly Report. We expect to continue to incur substantial losses for the foreseeable future, and our transition to profitability will depend upon successful development, approval and commercialization of our product candidates and upon achievement of sufficient revenues to support our cost structure.
Previous wording
In the third quarter of 2025, we commenced dosing in a Phase 2a clinical trial of ORKA-001 in patients with moderate-to-severe PsO (also known as “EVERLAST-A”). EVERLAST-A enrolled 84 patients randomized 3:1 to receive 600 mg of ORKA-001 at Weeks 0 and 4 or matching placebo. At Week 28, patients who achieved PASI 100 were randomized 2:1 to an arm where either (1) they do not receive another dose until disease recurrence (to evaluate the possibility of both yearly dosing and extended off-treatment remissions) or (2) they receive 300 mg ORKA-001 every six months. In April 2026, we presented Week 16 data for all EVERLAST-A patients, showing that 40 of 63 participants (63.5%) treated with ORKA-001 achieved the primary endpoint of PASI 100, representing a 100% reduction from baseline in the Psoriasis Area and Severity Index (“PASI”), with identical results observed for Investigator’s Global Assessment (“IGA”) 0. Other key secondary endpoints included PASI 90 at Week 16, achieved by 83% of participants, and IGA 0/1 at Week 16, achieved by 84% of participants. ORKA-001 was observed as well tolerated with a safety profile consistent with prior IL-23p19 inhibitors. There were no serious treatment-emergent adverse events (“TEAEs”) and only one severe TEAE, which occurred in the placebo group. Additionally, there were no injection site reactions. Eligible patients initially randomized to ORKA-001 have the option to transition to the open-label extension study of ORKA-001 at Week 52, and eligible patients initially randomized to placebo have the option to transition to the open-label extension study at Week 28. We plan to share Week 28 data from all patients at the end of the third quarter of 2026. We also plan to announce Week 52 data from all patients by the end of 2026.
Current wording
In the third quarter of 2025, we commenced dosing in a Phase 2a clinical trial of ORKA-001 in patients with moderate-to-severe PsO (also known as “EVERLAST-A”). EVERLAST-A enrolled 84 patients randomized 3:1 to receive 600 mg of ORKA-001 at Weeks 0 and 4 or matching placebo. Patients initially randomized to placebo received 600 mg of ORKA-001 at Weeks 16 and 20. At Week 28, patients who achieved PASI 100 were randomized 2:1 to an arm where either (1) they do not receive another dose until disease recurrence (to evaluate the possibility of both yearly dosing and extended off-treatment remissions) or (2) they receive 300 mg ORKA-001 every six months. Eligible patients initially randomized to ORKA-001 have the option to transition to the open-label extension study of ORKA-001 at Week 52, and eligible patients initially randomized to placebo have the option to transition to the open-label extension study at Week 28.
Previous wording
Additionally, we commenced dosing in a Phase 2b clinical trial of ORKA-001 in patients with moderate-to-severe PsO (also known as “EVERLAST-B”) in December 2025. EVERLAST-B enrolled 187 patients and is designed to evaluate three dose levels of ORKA-001: 37.5 mg at Week 0, 300 mg at Weeks 0 and 4, and 600 mg at Weeks 0 and 4, versus placebo. The primary endpoint is PASI 100 at Week 16. Building on EVERLAST-A, this design is intended to further test the potential for ORKA-001 to achieve yearly dosing, higher efficacy and extended off-treatment remissions. At Week 28, patients who have achieved PASI 100 will be re-randomized 1:1 to either a 600 mg dose once yearly or placebo. Patients who have not achieved PASI 100 at Week 28 will receive a 300 mg dose every six months. Eligible patients initially randomized to placebo have the option to roll over into the open-label extension study of ORKA-001 at Week 28. We expect to announce Week 16 data from EVERLAST-B in the fourth quarter of 2026.
Current wording
Additionally, we commenced dosing in a Phase 2b clinical trial of ORKA-001 in patients with moderate-to-severe PsO (also known as “EVERLAST-B”) in December 2025. EVERLAST-B enrolled 187 patients randomized equally to four treatment groups: 37.5 mg ORKA-001 at Week 0, 300 mg ORKA-001 at Weeks 0 and 4, 600 mg ORKA-001 at Weeks 0 and 4, or placebo. The primary endpoint was PASI 100 at Week 16. Building on EVERLAST-A, this design is intended to further test the potential for ORKA-001 to achieve yearly dosing, higher efficacy and extended off-treatment remissions. At Week 28, patients who have achieved PASI 100 will be re-randomized 1:1 to either a 600 mg dose once yearly or placebo. Patients who have not achieved PASI 100 at Week 28 will receive a 300 mg dose every six months. Eligible patients initially randomized to placebo have the option to roll over into the open-label extension study of ORKA-001 at Week 28. The trial continues through Week 100 to assess durability of response, maintenance dosing, and long-term safety.
Previous wording
Based on these Phase 1 results, we initiated ORCA-SURGE, a Phase 2 trial of ORKA-002 in patients with moderate-to-severe PsO, in February 2026. ORCA-SURGE is designed to enroll approximately 160 patients randomized 1:1:1:1 to receive 40 mg, 160 mg or 320 mg of ORKA-002 at Weeks 0 and 4, or matching placebo. The primary endpoint is PASI 100 at Week 16. Maintenance dosing will evaluate the potential for twice-yearly dosing with ORKA-002. We expect to announce data from ORCA-SURGE in the first quarter of 2027.
Current wording
Based on these Phase 1 results, we initiated ORCA-SURGE, a Phase 2 trial of ORKA-002 in patients with moderate-to-severe PsO, in February 2026. ORCA-SURGE enrolled 171 patients randomized 1:1:1:1 to receive 40 mg, 160 mg or 320 mg of ORKA-002 at Weeks 0 and 4, or matching placebo. The primary endpoint is PASI 100 at Week 16. Maintenance dosing will evaluate the potential for twice-yearly dosing with ORKA-002. We expect to announce Week 16 data from ORCA-SURGE in the first quarter of 2027.
Previous wording
In addition, we initiated ORCA-SPLASH, a Phase 2 trial of ORKA-002 in patients with moderate-to-severe HS. ORCA-SPLASH is designed to enroll approximately 160 patients. Patients will be randomized 1:1 to receive 320 mg of ORKA-002 or placebo at Week 0, Week 4, Week 8, and Week 12. The primary endpoint is HiSCR75 (Hidradenitis Suppurativa Clinical Response 75) at Week 16. Participants then enter an open-label maintenance period evaluating 320 mg of ORKA-002 every 12 weeks.
Current wording
In addition, we initiated ORCA-SPLASH, a Phase 2 trial of ORKA-002 in patients with moderate-to-severe HS, in August 2026. ORCA-SPLASH is designed to enroll approximately 160 patients. Patients will be randomized 1:1 to receive 320 mg of ORKA-002 or placebo at Week 0, Week 4, Week 8, and Week 12. The primary endpoint is HiSCR75 (Hidradenitis Suppurativa Clinical Response 75) at Week 16. Participants then enter an open-label maintenance period evaluating 320 mg of ORKA-002 every 12 weeks.
Previous wording
Pursuant to the terms of each of the License Agreements, we are obligated to pay Paragon non-refundable milestone payments of up to $12.0 million under each respective agreement upon the achievement of certain clinical development milestones and up to $10.0 million under each respective agreement upon the achievement of certain regulatory milestones. In addition, we are obligated to pay Paragon a low single-digit percentage royalty for antibody products for each of ORKA-001 and ORKA-002. For each of the License Agreements, the royalty term ends on the later of (i) the last-to-expire licensed patent or our patent directed to the manufacture, use or sale of a licensed antibody in the country at issue or (ii) 12 years from the date of first sale of our product. There is also a royalty step-down if there is no Paragon patent in effect during the royalty term for each program.
Current wording
Pursuant to the terms of each of the License Agreements and the ORKA-003 License Agreement, we are obligated to pay Paragon non-refundable milestone payments of up to $12.0 million under each respective agreement upon the achievement of certain clinical development milestones and up to $10.0 million under each respective agreement upon the achievement of certain regulatory milestones. In addition, we are obligated to pay Paragon a low single-digit percentage royalty for antibody products for each of ORKA-001, ORKA-002 and ORKA-003. For each of the License Agreements and the ORKA-003 License Agreement, the royalty term ends on the later of (i) the last-to-expire licensed patent or our patent directed to the manufacture, use or sale of a licensed antibody in the country at issue or (ii) 12 years from the date of first sale of our product. There is also a royalty step-down if there is no Paragon patent in effect during the royalty term for each program.
Previous wording
During the three and six months ended June 30, 2026, we incurred and expensed a milestone of nil and $3.0 million for the ORKA-002 License Agreement, respectively. Pursuant to the License Agreements, as of June 30, 2026, we have incurred and expensed milestone payments of $7.0 million for each of ORKA-001 and ORKA-002.
Current wording
During the three and nine months ended September 30, 2026, we incurred and expensed a milestone of nil and $3.0 million for the ORKA-002 License Agreement, respectively. Pursuant to the License Agreements, as of September 30, 2026, we have incurred and expensed milestone payments of $7.0 million for each of ORKA-001 and ORKA-002 and have not incurred or expensed any milestone payments in connection with the ORKA-003 License Agreement.
Previous wording
External research and development expenses, including CROs, CMOs and other third-party preclinical studies and clinical trials expenses increased by $14.5 million, from $16.4 million for the three months ended June 30, 2025 to $30.9 million for the three months ended June 30, 2026. The increase is primarily related to increased CRO expenses related to our ongoing clinical trials, a $5.0 million expense related to a non-refundable upfront payment made to Halozyme Hypercon, Inc. (“Halozyme”) pursuant to our collaboration and license agreement, and increased CMO product development and manufacturing expenses. These increases were partially offset by the absence of a $2.5 million milestone pursuant to ORKA-002 License Agreement with Paragon related to dosing of the first patient in a Phase 1 trial during the prior year.
Current wording
External research and development expenses, including CROs, CMOs and other third-party preclinical studies and clinical trials expenses increased by $22.7 million, from $15.6 million for the three months ended September 30, 2025 to $38.3 million for the three months ended September 30, 2026. The increase is primarily related to increased CRO expenses related to our ongoing clinical trials and increased CMO product development and manufacturing expenses. These increases were partially offset by the absence of a $3.0 million milestone pursuant to ORKA-001 License Agreement with Paragon related to dosing of the first patient in a Phase 2 trial during the prior year.
Previous wording
Personnel-related expenses, excluding stock-based compensation, increased by $3.5 million, from $3.3 million for the three months ended June 30, 2025 to $6.8 million for the three months ended June 30, 2026. This increase was primarily attributable to the growth in our research and development headcount to support our growing portfolio of clinical trials. Stock-based compensation expense increased by $0.5 million, from $3.4 million for the three months ended June 30, 2025 to $3.9 million for the three months ended June 30, 2026. The increase in stock-based compensation expense is primarily related to a $2.2 million increase related to employee awards due to an increase in research and development headcount, partially offset by a $1.7 million decrease due to the absence of expense related to the Paruka warrant liability under the Option Agreements, which was recorded in the prior year.
Current wording
Personnel-related expenses, excluding stock-based compensation, increased by $5.0 million, from $3.8 million for the three months ended September 30, 2025 to $8.8 million for the three months ended September 30, 2026. This increase was primarily attributable to the growth in our research and development headcount to support our growing portfolio of clinical trials. Stock-based compensation expense decreased by $3.6 million, from $8.3 million for the three months ended September 30, 2025 to $4.7 million for the three months ended September 30, 2026. The decrease in stock-based compensation expense is primarily related to a $6.6 million decrease due to absence of expense related to the Paruka warrant liability under the Option Agreements, which was recorded in the prior year, partially offset by a $3.0 million increase related to employee awards due to an increase in research and development headcount.
Previous wording
Other research and development expenses increased by $0.6 million, from $1.0 million for the three months ended June 30, 2025 to $1.6 million for the three months ended June 30, 2026, primarily due to an increase in our research and development employee count.
Current wording
Other research and development expenses increased by $0.6 million, from $1.3 million for the three months ended September 30, 2025 to $1.9 million for the three months ended September 30, 2026, primarily due to a higher allocation of shared costs to support the increase in our research and development employee headcount.
Previous wording
Personnel-related expenses, including stock-based compensation, increased by $2.1 million, from $3.4 million for the three months ended June 30, 2025 to $5.5 million for the three months ended June 30, 2026. This increase was primarily attributable to a $1.7 million increase in stock-based compensation expense due to additional equity awards issued to existing employees and new equity awards granted to new hires, and an increase in headcount to support our growing operations as a public company.
Current wording
Personnel-related expenses, excluding stock-based compensation, increased by $1.0 million, from $1.9 million for the three months ended September 30, 2025 to $2.9 million for the three months ended September 30, 2026. This increase was primarily attributable to an increase in headcount to support our growing operations as a public company.
Previous wording
Interest income from cash equivalents and marketable securities was $8.9 million and $3.9 million for the three months ended June 30, 2026 and 2025, respectively. The increase was primarily due to interest earned on higher cash and marketable securities balances.
Current wording
Interest income from cash equivalents and marketable securities was $12.2 million and $3.8 million for the three months ended September 30, 2026 and 2025, respectively. The increase was primarily due to interest earned on higher cash and marketable securities balances.
Previous wording
External research and development expenses, including CROs, CMOs and other third-party preclinical studies and clinical trials expenses increased by $19.2 million, from $30.0 million for the six months ended June 30, 2025 to $49.3 million for the six months ended June 30, 2026. The increase is primarily related to an increase in our CRO expenses related to our ongoing clinical trials and a $5.0 million expense related to a non-refundable upfront payment made to Halozyme pursuant to our collaboration and license agreement. These increases were partially offset by lower research related expenses incurred during the current year.
Current wording
External research and development expenses, including CROs, CMOs and other third-party preclinical studies and clinical trials expenses increased by $41.9 million, from $45.6 million for the nine months ended September 30, 2025 to $87.5 million for the nine months ended September 30, 2026. The increase is primarily related to an increase in our CRO expenses related to our ongoing clinical trials, increased CMO product development and manufacturing expenses, and a $5.0 million expense related to a non-refundable upfront payment made to Halozyme pursuant to our collaboration and license agreement. These increases were partially offset by lower research related expenses incurred during the current year.
Previous wording
Personnel-related expenses, excluding stock-based compensation, increased by $7.1 million, from $5.8 million for the six months ended June 30, 2025 to $12.9 million for the six months ended June 30, 2026. This increase was primarily attributable to the growth in our research and development headcount to support our growing portfolio of clinical trials. Stock-based compensation expense increased by $1.1 million, from $6.4 million for the six months ended June 30, 2025 to $7.5 million for the six months ended June 30, 2026. The increase in stock-based compensation expense is primarily related to a $4.2 million increase related to employee awards due to an increase in research and development headcount, partially offset by a $3.1 million decrease due to the absence of expense related to the Paruka warrant liability under the Option Agreements, which was recorded in the prior year.
Current wording
Personnel-related expenses, excluding stock-based compensation, increased by $12.1 million, from $9.5 million for the nine months ended September 30, 2025 to $21.6 million for the nine months ended September 30, 2026. This increase was primarily attributable to the growth in our research and development headcount to support our growing portfolio of clinical trials. Stock-based compensation expense decreased by $2.5 million, from $14.7 million for the nine months ended September 30, 2025 to $12.2 million for the nine months ended September 30, 2026. The decrease in stock-based compensation expense is primarily related to a $9.7 million decrease due to absence of expense related to the Paruka warrant liability under the Option Agreements, which was recorded in the prior year, partially offset by a $7.2 million increase related to employee awards due to an increase in research and development headcount.
Previous wording
Other research and development expenses increased by $0.9 million, from $1.9 million for the six months ended June 30, 2025 to $2.8 million for the six months ended June 30, 2026, primarily due to an increase in our research and development employee count.
Current wording
Other research and development expenses increased by $1.5 million, from $3.1 million for the nine months ended September 30, 2025 to $4.7 million for the nine months ended September 30, 2026, primarily due to a higher allocation of shared costs to support the increase in our research and development employee headcount.
Previous wording
Personnel-related expenses, including stock-based compensation, increased by $4.0 million, from $7.0 million for the six months ended June 30, 2025 to $11.0 million for the six months ended June 30, 2026. This increase was primarily attributable to a $3.2 million increase in stock-based compensation expense due to additional equity awards issued to existing employees and new equity awards granted to new hires, and an increase in cash personnel costs due to additional headcount to support our growing operations as a public company.
Current wording
Personnel-related expenses, excluding stock-based compensation, increased by $1.8 million, from $5.4 million for the nine months ended September 30, 2025 to $7.1 million for the nine months ended September 30, 2026. This increase was primarily attributable to an increase in cash personnel costs due to additional headcount to support our growing operations as a public company.
Previous wording
Expenses related to professional and consulting services increased by $0.5 million, from $0.8 million for the three months ended June 30, 2025 to $1.2 million for the three months ended June 30, 2026, due to higher spending on legal and other professional services to support our growing operations as a public company.
Current wording
Other general and administrative expenses increased by $0.4 million, from $3.9 million for the nine months ended September 30, 2025 to $4.3 million for the nine months ended September 30, 2026, primarily due to higher spending on professional services to support our growing operations as a public company, partly offset by higher allocation of shared costs to research and development, reflecting growth in our research and development headcount.
Previous wording
Interest income from cash equivalents and marketable securities was $13.5 million and $7.9 million for the six months ended June 30, 2026 and 2025, respectively. The increase was primarily due to interest earned on higher cash and marketable securities balances.
Current wording
Interest income from cash equivalents and marketable securities was $25.7 million and $11.8 million for the nine months ended September 30, 2026 and 2025, respectively. The increase was primarily due to interest earned on higher cash and marketable securities balances.
Previous wording
As of June 30, 2026, we had $1.1 billion of cash, cash equivalents, and marketable securities.
Current wording
As of September 30, 2026, we had $1.2 billion of cash, cash equivalents, and marketable securities.
Previous wording
In October 2025, we entered into a Sales Agreement with TD Securities (USA) LLC (the “Sales Agreement”), as our sales agent, pursuant to which we may issue and sell, from time to time, shares of common stock for aggregate gross proceeds of up to $200.0 million under an at-the-market (“ATM”) equity offering program. We are not obligated to make any sales of shares under the Sales Agreement. During the three months ended March 31, 2026, we issued and sold an aggregate of 1,167,895 shares of the Company’s common stock pursuant to the ATM offering program for total net proceeds of $38.9 million after deducting sales agents’ commissions. In addition, in July 2026, we sold 1,499,500 shares of our common stock pursuant to the ATM offering program for net proceeds of $122.5 million, after deducting sales agents’ commissions. In April 2026, we sold 9,660,000 shares of our common stock in an underwritten public offering for net proceeds of $658.3 million, after deducting underwriting discounts and commissions and related issuance expenses.
Current wording
During the three months ended September 30, 2026, we issued and sold an aggregate of 1,499,500 shares of our common stock pursuant to the ATM offering program and the Prior Registration Statement for net proceeds of $122.5 million, after deducting sales agents’ commissions. During the nine months ended September 30, 2026, we issued and sold an aggregate of 2,667,395 shares of our common stock pursuant to the ATM offering program and the Prior Registration Statement for net proceeds of $161.4 million, after deducting sales agents’ commissions. In April 2026, we sold 9,660,000 shares of our common stock in an underwritten public offering for net proceeds of $658.3 million, after deducting underwriting discounts and commissions and related issuance expenses.
Previous wording
For the six months ended June 30, 2026, net cash used in operating activities was $56.7 million, which was primarily attributable to a net loss of $73.0 million, partially offset by net non-cash charges of $13.2 million and net cash provided by changes in our operating assets and liabilities of $3.1 million. Net cash provided by changes in our operating assets and liabilities were primarily comprised of an increase of $3.8 million in accounts payable and an increase of $3.8 million in accrued expenses and other liabilities, partially offset by an increase of $4.2 million in prepaid expenses and other current assets and a decrease of $0.3 million in operating lease liability. Net non-cash charges primarily comprised of $14.3 million in stock-based compensation expense, partially offset by $1.4 million in net accretion of premiums and discounts on marketable securities.
Current wording
For the nine months ended September 30, 2026, net cash used in operating activities was $101.0 million, which was primarily attributable to a net loss of $123.0 million, partially offset by net non-cash charges of $20.6 million and net cash provided by changes in our operating assets and liabilities of $1.3 million. Net cash provided by changes in our operating assets and liabilities were primarily comprised of an increase of $10.2 million in accounts payable and an increase of $5.9 million in accrued expenses and other liabilities, partially offset by an increase of $14.4 million in prepaid expenses and other current assets and a decrease of $0.4 million in operating lease liability. Net non-cash charges primarily comprised of $23.4 million in stock-based compensation expense, partially offset by $3.4 million in net accretion of premiums and discounts on marketable securities.
Previous wording
For the six months ended June 30, 2025, net cash used in operating activities was $44.0 million, which was primarily attributable to a net loss of $45.6 million and net changes in our operating assets and liabilities of $5.3 million, partially offset by net non-cash charges of $6.9 million. Net changes in our operating assets and liabilities were primarily comprised of a decrease of $5.9 million in related party accounts payable and other current liabilities and an increase of $1.2 million in accounts payable. Net non-cash charges primarily comprised of an increase of $10.0 million in stock-based compensation expense, partially offset by $3.3 million in net accretion of premiums and discounts on marketable securities.
Current wording
For the nine months ended September 30, 2025, net cash used in operating activities was $65.6 million, which was primarily attributable to a net loss of $75.9 million and net cash used by changes in our operating assets and liabilities of $5.9 million, partially offset by net non-cash charges of $16.2 million. Net cash used by changes in our operating assets and liabilities were primarily comprised of a decrease of $6.0 million in related party accounts payable and other current liabilities, an increase of $3.2 million in prepaid expenses and other current assets, partly offset by an increase of $5.0 million in accrued expenses and other current liabilities. Net non-cash charges primarily comprised of $20.1 million in stock-based compensation expense (includes $9.7 million from Paruka Warrant Obligation), partially offset by $4.3 million in net accretion of premiums and discounts on marketable securities.
Previous wording
For the six months ended June 30, 2025, net cash provided by investing activities was $47.7 million, which included $200.1 million in proceeds from maturities of marketable securities, partially offset by $152.3 million in purchases of marketable securities.
Current wording
For the nine months ended September 30, 2026, net cash used in investing activities was $584.8 million, which included $910.9 million in purchases of marketable securities, $0.2 million in purchases of property and equipment, partially offset by $326.3 million in proceeds from maturities of marketable securities.
Previous wording
For the six months ended June 30, 2026, net cash used in investing activities was $425.4 million, which included $581.4 million in purchases of marketable securities, $0.1 million in purchases of property and equipment, partially offset by $156.1 million in proceeds from maturities of marketable securities.
Current wording
For the nine months ended September 30, 2025, net cash used in investing activities was $74.7 million, which included $420.0 million in purchases of marketable securities, $0.1 million in purchases of property and equipment, partially offset by $345.4 million in proceeds from maturities of marketable securities.
Previous wording
For the six months ended June 30, 2026, net cash provided by financing activities was $703.6 million due to $658.3 million of net proceeds from the April 2026 underwritten public offering, $38.9 million of net proceeds from the ATM offering program, $6.1 million of proceeds from the issuance of shares of common stock in connection with exercises of stock options and employee warrants, and $0.3 million of proceeds from the issuance of common stock under the employee stock purchase plan.
Current wording
For the nine months ended September 30, 2026, net cash provided by financing activities was $830.4 million due to $658.3 million of net proceeds from the April 2026 underwritten public offering, $161.4 million of net proceeds from the ATM offering program, $10.4 million of proceeds from the issuance of shares of common stock in connection with exercises of stock options and employee warrants, and $0.3 million of proceeds from the issuance of common stock under the employee stock purchase plan.
Previous wording
For the six months ended June 30, 2025, net cash provided by financing activities was $0.1 million due to proceeds from the issuance of shares of common stock in connection with purchases under our employee stock purchase plan.
Current wording
For the nine months ended September 30, 2025, net cash provided by financing activities was $170.0 million due to $169.9 million of net proceeds related to a private placement with certain institutional investors (the “2025 PIPE Financing”) which closed on September 19, 2025 and $0.1 million proceeds from the issuance of shares of common stock in connection with purchases under our employee stock purchase plan.
Rearranged current paragraphs (4)
Current report — wording carried from elsewhere
In April 2026, we presented Week 16 data for all EVERLAST-A patients, showing that 40 of 63 participants (63.5%) treated with ORKA-001 achieved the primary endpoint of PASI 100, representing a 100% reduction from baseline in the Psoriasis Area and Severity Index (“PASI”), with identical results observed for Investigator’s Global Assessment (“IGA”) 0. Other key secondary endpoints included PASI 90 at Week 16, achieved by 83% of participants, and IGA 0/1 at Week 16, achieved by 84% of participants. Through Week 16, ORKA-001 was observed as well tolerated with a safety profile consistent with prior IL-23p19 inhibitors. There were no serious treatment-emergent adverse events (“TEAEs”) and only one severe TEAE, which occurred in the placebo group. Additionally, there were no injection site reactions.
Current report — wording carried from elsewhere
Stock-based compensation expense increased by $2.6 million, from $1.8 million for the three months ended September 30, 2025 to $4.4 million for the three months ended September 30, 2026, primarily due to additional equity awards issued to existing employees and equity awards granted to new hires.
Current report — wording carried from elsewhere
In October 2025, we entered into a Sales Agreement (the “Initial Sales Agreement”) with TD Securities (USA) LLC, as our sales agent, pursuant to which we could issue and sell, from time to time, shares of common stock for aggregate gross proceeds of up to $200.0 million under an at-the-market (“ATM”) equity offering program pursuant to a registration statement on Form S-3 (the “Prior Registration Statement”). The Prior Registration Statement was deemed terminated as of August 27, 2026.
Current report — wording carried from elsewhere
On August 21, 2026, we entered into an amendment to the Initial Sales Agreement (as amended, the “Sales Agreement”), pursuant to which we may issue and sell, from time to time, shares of common stock for aggregate gross proceeds of up to $500.0 million under the ATM equity offering program, pursuant to a registration statement on Form S-3. We are not obligated to make any sales of shares under the Sales Agreement. As of September 30, 2026, an amount of $500.0 million remained available under the ATM program.