Oruka Therapeutics, Inc.
For the period ended Sep 30, 2025. Filed Nov 12, 2025.
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, 2025 · Filed Nov 12, 2025
ORKA$102.86+7.1%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-11.
0001213900-25-074281
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-12.
0001213900-25-109182
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.
60 unchanged; 30 reworded; 13 added; 9 removed; 1 previous and 2 current paragraphs rearranged.
Tables are not compared: 31 previous and 30 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 (13)
Current report
Our Portfolio and Development Plans
Current report
We initiated a Phase 1 trial of ORKA-001 in the fourth quarter of 2024 and in September 2025, we announced the interim results at the European Academy of Dermatology and Venereology (EADV) Congress. ORKA-001 showed a half-life of approximately 100 days. Single doses of ORKA-001 demonstrated complete and sustained inhibition of STAT3 signaling, a downstream marker of IL-23 activity, in an ex vivo assay through 24 weeks (the longest follow-up available). ORKA-001 was well tolerated at all dose levels, with a favorable safety profile consistent with the anti-IL-23 class. The trial remains blinded, and as of August 6, 2025, which was the data cutoff date, all subjects remained on trial.
Current report
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”). We expect to share efficacy and response duration data from this study in the second half of 2026. EVERLAST-A is expected to enroll approximately 80 patients randomized 3:1 to receive 600 mg of ORKA-001 at Weeks 0 and 4 or matching placebo. The primary endpoint is PASI 100 at Week 16. At Week 28, patients who have achieved PASI 100 will be 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.
Current report
Additionally, in the third quarter of 2025, we announced our plans to initiate a dose-ranging Phase 2b trial of ORKA-001 in moderate-to-severe PsO patients (also known as “EVERLAST-B”) in the first half of 2026. EVERLAST-B will 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 will be PASI 100 at Week 16. To expedite development, EVERLAST-B dosing is projected to begin enrolling before the completion of EVERLAST-A.
Current report
PIPE Financings
Current report
Research and development expenses increased by $3.3 million, from $25.7 million for the three months ended September 30, 2024 to $29.0 million for the three months ended September 30, 2025.
Current report
General and administrative expenses increased by $1.4 million, from $3.8 million for the three months ended September 30, 2024 to $5.1 million for the three months ended September 30, 2025.
Current report
Other general and administrative expenses decreased by $0.5 million primarily due to facilities and allocated overhead expenses being allocated to research and development expenses as a result of the increase in our research and development employee count.
Current report
Research and development expenses increased by $23.4 million, from $49.6 million for the period from February 6, 2024 (inception) to September 30, 2024 to $73.0 million for the nine months ended September 30, 2025.
Current report
General and administrative expenses increased by $6.4 million, from $8.2 million for the period from February 6, 2024 (inception) to September 30, 2024 to $14.6 million for the nine months ended September 30, 2025.
Current report
Other general and administrative expenses decreased by $0.3 million primarily due to facilities and allocated overhead expenses being allocated to research and development expenses as a result of the increase in our research and development employee count.
Current report
In October 2025, we entered into a Sales Agreement with TD Securities (USA) LLC (the “Sales Agreement”), as its sales agent, pursuant to which we may issue and sell, from time to time, shares of Company Common Stock for aggregate gross proceeds of up to $200.0 million under an at-the-market equity offering program. We are not obligated to make any sales of shares under the Sales Agreement.
Current report
From February 6, 2024 (inception) to September 30, 2024, net cash used in investing activities was $0.2 million, which was attributable to purchases of property and equipment.
Removed paragraphs (9)
Previous report
Recent Developments
Previous report
PIPE Financing
Previous report
Research and development expenses increased by $5.4 million, from $18.7 million for the three months ended June 30, 2024 to $24.1 million for the three months ended June 30, 2025.
Previous report
General and administrative expenses increased by $1.5 million, from $2.8 million for the three months ended June 30, 2024 to $4.3 million for the three months ended June 30, 2025.
Previous report
Other general and administrative expenses increased by $0.1 million primarily due to facilities and allocated overhead expenses as we commenced using our leased Menlo Park office space from June 2024 and Waltham office from April 2025, as well as an increase in our employee count.
Previous report
Research and development expenses increased by $20.1 million, from $23.9 million for the period from February 6, 2024 (inception) to June 30, 2024 to $44.0 million for the six months ended June 30, 2025.
Previous report
General and administrative expenses increased by $5.0 million, from $4.5 million for the period from February 6, 2024 (inception) to June 30, 2024 to $9.5 million for the six months ended June 30, 2025.
Previous report
Other general and administrative expenses increased by $0.2 million primarily due to facilities and allocated overhead expenses as we commenced using our leased Menlo Park office space from June 2024 and Waltham office from April 2025, as well as an increase in our employee count.
Previous report
From February 6, 2024 (inception) to June 30, 2024, no cash was used in or provided by investing activities.
Reworded paragraphs (30)
Previous wording
Since our inception in February 2024, we have devoted substantially all of our resources to raising capital, organizing and staffing our company, business and scientific planning, conducting discovery and research activities, establishing and protecting our intellectual property portfolio, establishing arrangements with third parties for the manufacture of our programs and component materials, developing and progressing our pipeline, and providing general and administrative support for these operations. We do not have any products approved for sale and have not generated any revenue from product sales. To date, we have funded our operations primarily with proceeds from the issuance of convertible preferred stock, common stock, a convertible note, pre-funded warrants, and the proceeds from the reverse recapitalization and merger, our Pre-Closing Financing and subsequent PIPE Financing (as defined and further described in “Recent Developments” below).
Current wording
Since our inception in February 2024, we have devoted substantially all of our resources to raising capital, organizing and staffing our company, business and scientific planning, conducting discovery and research activities, establishing and protecting our intellectual property portfolio, establishing arrangements with third parties for the manufacture of our programs and component materials, developing and progressing our pipeline, and providing general and administrative support for these operations. We do not have any products approved for sale and have not generated any revenue from product sales. To date, we have funded our operations primarily with proceeds from the issuance of convertible preferred stock, common stock, a convertible note, pre-funded warrants, and the proceeds from the reverse recapitalization and merger, our Pre-Closing Financing and subsequent PIPE Financings (as defined and further described below).
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. During the three and six months ended June 30, 2025, we generated net losses of $24.6 million and $45.6 million, respectively, and for the six months ended June 30, 2025, we used net cash of $44.0 million for our operating activities.
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. During the three and nine months ended September 30, 2025, we generated net losses of $30.3 million and $75.9 million, respectively, and for the nine months ended September 30, 2025, we used net cash of $65.6 million for our operating activities.
Previous wording
We had cash, cash equivalents, and marketable securities of $351.5 million as of June 30, 2025. 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 $500.9 million as of September 30, 2025. 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
ORKA-001 is a high affinity, extended half-life monoclonal antibody (“mAb”) designed to target IL-23p19. IL-23 is a pro-inflammatory cytokine that plays a critical role in the proliferation and development of T helper 17 (“Th17”) cells, which are the primary drivers of several autoimmune and inflammatory disorders, including PsO. IL-23 is composed of two subunits: a p40 subunit that is shared with IL-12 and a p19 subunit that is specific to IL-23. First-generation IL-23 antibodies bound p40 and inhibited both IL-12 and IL-23 signaling, while more recent IL-23 antibodies targeting the p19 subunit have shown improved efficacy and safety. Based on preclinical evidence, we believe that ORKA-001 could achieve higher response rates than established therapies in PsO while requiring less frequent dosing and maintaining the favorable safety profile of therapies targeting IL-23p19.
Current wording
ORKA-001 is a high affinity, extended half-life monoclonal antibody (“mAb”) designed to target IL-23p19. IL-23 is a pro-inflammatory cytokine that plays a critical role in the proliferation and development of T helper 17 (“Th17”) cells, which are the primary drivers of several autoimmune and inflammatory disorders, including PsO. IL-23 is composed of two subunits: a p40 subunit that is shared with IL-12 and a p19 subunit that is specific to IL-23. First-generation IL-23 antibodies bound p40 and inhibited both IL-12 and IL-23 signaling, while more recent IL-23 antibodies targeting the p19 subunit have shown improved efficacy and safety. Based on clinical evidence, we believe that ORKA-001 could achieve higher response rates than established therapies in PsO while requiring less frequent dosing and maintaining the favorable safety profile of therapies targeting IL-23p19.
Previous wording
In July 2025, the United States Food and Drug Administration (“FDA”) cleared our investigational new drug (“IND”) application and Health Canada cleared our Clinical Trial Application (“CTA”) for our Phase 2a trial of ORKA-001 in moderate-to-severe PsO, called EVERLAST-A. 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. We expect to share efficacy and response duration data from this study in the second half of 2026. Based on recent precedent for PsO, we anticipate that the entire development program from first-in-human to biologics license application (“BLA”) filing could take as little as six to seven years based on the averages for recently approved medicines. However, we have no control over the length of time needed for the FDA review, and this timeline could vary.
Current wording
Based on recent precedent for PsO, we anticipate that the entire development program from first-in-human to biologics license application (“BLA”) filing could take as little as six to seven years based on the averages for recently approved medicines. However, we have no control over the length of time needed for the FDA review, and this timeline could vary.
Previous wording
ORKA-002 is a high affinity, extended half-life mAb designed to target IL-17A and IL-17F (“IL-17A/F”). IL-17 inhibition has become central to the treatment of psoriatic diseases, including PsO and PsA, and has also shown efficacy in other I&I indications, such as hidradenitis suppurativa and axial spondyloarthritis. More recently, the importance of inhibiting the IL-17F isoform along with IL-17A has become appreciated, and dual blockade with the recently approved therapy Bimzelx (bimekizumab) has led to higher response rates in patients than blockade of IL-17A alone. ORKA-002 is designed to bind IL-17A/F at similar epitopes, or binding sites, and affinity ranges as bimekizumab, but incorporates half-life extension technology that could enable more convenient dosing intervals. We initiated the dosing of healthy volunteers in a Phase 1 trial of ORKA-002 in the second quarter of 2025. We expect to share interim data from the first-in-human trial in healthy volunteers, including initial pharmacokinetic data, around year end 2025.
Current wording
ORKA-002 is a high affinity, extended half-life mAb designed to target IL-17A and IL-17F (“IL-17A/F”). IL-17 inhibition has become central to the treatment of psoriatic diseases, including PsO and PsA, and has also shown efficacy in other I&I indications, such as hidradenitis suppurativa (“HS”) and axial spondyloarthritis. More recently, the importance of inhibiting the IL-17F isoform along with IL-17A has become appreciated, and dual blockade with the recently approved therapy Bimzelx® (bimekizumab) has led to higher response rates in patients than blockade of IL-17A alone. ORKA-002 is designed to bind IL-17A/F at similar epitopes, or binding sites, and affinity ranges as bimekizumab, but incorporates half-life extension technology that could enable more convenient dosing intervals. We initiated the dosing of healthy volunteers in a Phase 1 trial of ORKA-002 in the second quarter of 2025 and plan to initiate a Phase 2 clinical trial of ORKA-002 in the first half of 2026. We expect to share interim data from the Phase 1 trial of ORKA-002, including initial pharmacokinetic data, around year end 2025. The Company is also planning for a Phase 2 trial in HS.
Previous wording
On August 29, 2024 (the “Closing”), we completed the acquisition (the “Merger”) of the private company, Oruka Therapeutics, Inc. (“Pre-Merger Oruka”), a pre-clinical stage biotechnology company that was incorporated on February 6, 2024 under the direction of Peter Harwin, a Managing Member of Fairmount Funds Management LLC, for the purposes of holding rights to certain intellectual property being developed by Paragon Therapeutics, Inc. (“Paragon”). On August 29, 2024, we changed our name from “ARCA biopharma, Inc.” to “Oruka Therapeutics, Inc.” and our Nasdaq ticker symbol from “ABIO” to “ORKA”. Following consummation of the Merger, we effected a 1-for-12 reverse stock split (the “Reverse Stock Split”) of the common stock, par value $0.001 per share, of the Company (“Company Common Stock”). The Company Common Stock commenced trading on a post-Reverse Stock Split, post-Merger basis at the opening of trading on September 3, 2024.
Current wording
On August 29, 2024 (the “Closing”), we completed the acquisition (the “Merger”) of the private company, Oruka Therapeutics, Inc. (“Pre-Merger Oruka”), a pre-clinical stage biotechnology company that was incorporated on February 6, 2024 for the purposes of holding rights to certain intellectual property being developed by Paragon Therapeutics, Inc. (“Paragon”). On August 29, 2024, we changed our name from “ARCA biopharma, Inc.” to “Oruka Therapeutics, Inc.” and our Nasdaq ticker symbol from “ABIO” to “ORKA”. Following consummation of the Merger, we effected a 1-for-12 reverse stock split (the “Reverse Stock Split”) of the common stock, par value $0.001 per share, of the Company (“Company Common Stock”). The Company Common Stock commenced trading on a post-Reverse Stock Split, post-Merger basis at the opening of trading on September 3, 2024.
Previous wording
On September 11, 2024, we entered into a Securities Purchase Agreement for a private placement (the “PIPE Financing”) with certain institutional and accredited investors. The closing of the PIPE Financing occurred on September 13, 2024.
Current wording
On September 11, 2024, we entered into a Securities Purchase Agreement (the “2024 Securities Purchase Agreement”) for a private placement (the “2024 PIPE Financing”) with certain institutional and accredited investors. The closing of the 2024 PIPE Financing occurred on September 13, 2024.
Previous wording
Pursuant to the Securities Purchase Agreement, the investors purchased an aggregate of 5,600,000 shares of Company Common Stock at a purchase price of $23.00 per share, an aggregate of 2,439 shares of our Series A non-voting convertible preferred stock, par value $0.001 per share (“Company Series A Preferred Stock”), at a purchase price of $23,000.00 per share (each Company Series A Preferred Stock is convertible into 1,000 shares of Company Common Stock), and pre-funded warrants to purchase an aggregate of 680,000 shares of Company Common Stock at a purchase price of $22.999 per pre-funded warrant, for aggregate net proceeds of approximately $188.7 million (net of issuance costs of $11.9 million).
Current wording
Pursuant to the 2024 Securities Purchase Agreement, the investors purchased an aggregate of 5,600,000 shares of Company Common Stock at a purchase price of $23.00 per share, an aggregate of 2,439 shares of our Series A non-voting convertible preferred stock, par value $0.001 per share (“Company Series A Preferred Stock”), at a purchase price of $23,000.00 per share (each Company Series A Preferred Stock is convertible into 1,000 shares of Company Common Stock), and pre-funded warrants to purchase an aggregate of 680,000 shares of Company Common Stock at a purchase price of $22.999 per pre-funded warrant, for aggregate net proceeds of approximately $188.7 million (net of issuance costs of $11.9 million).
Previous wording
Pursuant to the License Agreements, as of June 30, 2025, we have incurred and expensed milestone payments of $4.0 million for each of ORKA-001 and ORKA-002. Subsequent to the quarter end, we dosed the first patient in a Phase 2a clinical trial for ORKA-001. In the third quarter of 2025, we accrued for the additional milestone payment of $3.0 million under the ORKA-001 License Agreement, as it became probable that the milestone would be achieved.
Current wording
Pursuant to the License Agreements, as of September 30, 2025, we have incurred and expensed milestone payments of $7.0 million and $4.0 million for ORKA-001 and ORKA-002, respectively.
Previous wording
External research and development expenses, including CROs, CMOs and other third-party preclinical studies and clinical trials expenses decreased by $0.7 million, from $17.1 million for the three months ended June 30, 2024 to $16.4 million for the three months ended June 30, 2025. The decrease is primarily related to the decrease in research expenses incurred by Paragon partially offset by increased CMO product development and manufacturing expenses and an increase in our CRO expenses related to our ongoing clinical trials and toxicology studies.
Current wording
External research and development expenses, including CROs, CMOs and other third-party preclinical studies and clinical trials expenses decreased by $0.3 million, from $15.9 million for the three months ended September 30, 2024 to $15.6 million for the three months ended September 30, 2025. The decrease is primarily related to the decrease in research expenses incurred by Paragon partially offset by increased CMO product development and manufacturing expenses and an increase in our CRO expenses related to our ongoing clinical trials and toxicology studies.
Previous wording
Personnel-related expenses increased by $2.4 million, from $0.9 million for the three months ended June 30, 2024 to $3.3 million for the three months ended June 30, 2025, as we continue hiring employees in our research and development organization. Stock-based compensation expense increased by $2.9 million, from $0.5 million for the three months ended June 30, 2024 to $3.4 million for the three months ended June 30, 2025. The increase in stock-based compensation expense is related to the $1.3 million increase in Paruka warrant liability under the Option Agreements and $1.6 million related to the increase in employee awards. Other research and development expenses increased by $0.8 million, from $0.2 million for the three months ended June 30, 2024 to $1.0 million for the three months ended June 30, 2025, primarily due to increases to facilities and allocated overhead expenses as we commenced using our leased Menlo Park office space from June 2024 and Waltham office from April 2025, as well as an increase in our research and development employee count.
Current wording
Personnel-related expenses increased by $2.5 million, from $1.3 million for the three months ended September 30, 2024 to $3.8 million for the three months ended September 30, 2025, as we continue hiring employees in our research and development organization. Stock-based compensation expense increased by $0.6 million, from $7.8 million for the three months ended September 30, 2024 to $8.3 million for the three months ended September 30, 2025. The increase in stock-based compensation expense is primarily related to a $1.3 million increase in employee awards, partially offset by a $0.7 million decrease in Paruka warrant liability under the Option Agreements. Other research and development expenses increased by $0.6 million, from $0.7 million for the three months ended September 30, 2024 to $1.3 million for the three months ended September 30, 2025, primarily due to increases to facilities and allocated overhead expenses as we commenced using our leased Waltham office from April 2025, as well as an increase in our research and development employee count.
Previous wording
Personnel-related expenses increased by $2.1 million, from $1.3 million for the three months ended June 30, 2024 to $3.4 million for the three months ended June 30, 2025, as a result of continued hiring of executives and administrative employees. Stock-based compensation expense increased by $1.5 million, from $0.2 million for the three months ended June 30, 2024 to $1.7 million for three months ended June 30, 2025.
Current wording
Personnel-related expenses increased by $1.3 million, from $2.4 million for the three months ended September 30, 2024 to $3.8 million for the three months ended September 30, 2025, as a result of continued hiring of executives and administrative employees. Stock-based compensation expense increased by $0.6 million, from $1.2 million for the three months ended September 30, 2024 to $1.8 million for three months ended September 30, 2025.
Previous wording
Expenses related to professional and consulting services decreased by $0.6 million, from $1.4 million for the three months ended June 30, 2024 to $0.8 million for the three months ended June 30, 2025, due to higher spending in the prior period on accounting, audit, and legal fees as we began preparation to become a public company.
Current wording
Expenses related to professional and consulting services increased by $0.5 million, from $0.8 million for the three months ended September 30, 2024 to $1.3 million for the three months ended September 30, 2025, due to higher spending on accounting, audit, and legal fees.
Previous wording
Interest income from cash equivalents and marketable securities was $3.9 million for the three months ended June 30, 2025. No interest income was recorded for the three months ended June 30, 2024.
Current wording
Interest income from cash equivalents and marketable securities was $3.8 million for the three months ended September 30, 2025. Interest income from money market funds was $1.3 million for the three months ended September 30, 2024.
Previous wording
No interest expense was recorded during the three months ended June 30, 2025. Interest expense of $0.8 million was incurred for the three months ended June 30, 2024 relating to the Convertible Note issued to Fairmount in March 2024.
Current wording
No interest expense was recorded during the three months ended September 30, 2025. Interest expense of $0.5 million was incurred for the three months ended September 30, 2024 relating to the Convertible Note issued to Fairmount in March 2024.
Previous wording
Comparison of the Six Months Ended June 30, 2025, and the period from February 6 (inception) to June 30, 2024
Current wording
Comparison of the Nine Months Ended September 30, 2025, and the period from February 6 (inception) to September 30, 2024
Previous wording
External research and development expenses, including CROs, CMOs and other third-party preclinical studies and clinical trials expenses increased by $8.0 million, from $22.0 million for the period from February 6, 2024 (inception) to June 30, 2024 to $30.0 million for the six months ended June 30, 2025. The increase is primarily related to increased CMO product development and manufacturing expenses, an increase in our CRO expenses related to our ongoing clinical trials and toxicology studies, partially offset by a reduction of research expenses incurred by Paragon.
Current wording
External research and development expenses, including CROs, CMOs and other third-party preclinical studies and clinical trials expenses increased by $7.7 million, from $37.9 million for the period from February 6, 2024 (inception) to September 30, 2024 to $45.6 million for the nine months ended September 30, 2025. The increase is primarily related to increased CMO product development and manufacturing expenses, an increase in our CRO expenses related to our ongoing clinical trials and toxicology studies, partially offset by a reduction of research expenses incurred by Paragon.
Previous wording
Personnel-related expenses increased by $4.7 million, from $1.1 million for the period from February 6, 2024 (inception) to June 30, 2024 to $5.8 million for the six months ended June 30, 2025, as we continue hiring employees in our research and development organization. Stock-based compensation expense increased by $5.8 million, from $0.5 million for the period from February 6, 2024 (inception) to June 30, 2024 to $6.4 million for the six months ended June 30, 2025. Stock-based compensation expense increased by $3.2 million due to the increase in employee awards and $2.6 million due to an increase in Paruka warrant liability under the Option Agreements. Other research and development expenses increased by $1.6 million, from $0.2 million for the period from February 6, 2024 (inception) to June 30, 2024 to $1.8 million for the six months ended June 30, 2025, primarily due to facilities and allocated overhead expenses as we commenced using our leased Menlo Park office space from June 2024 and Waltham office from April 2025, as well as increased our research and development employee count.
Current wording
Personnel-related expenses increased by $7.2 million, from $2.4 million for the period from February 6, 2024 (inception) to September 30, 2024 to $9.5 million for the nine months ended September 30, 2025, as we continue hiring employees in our research and development organization. Stock-based compensation expense increased by $6.4 million, from $8.3 million for the period from February 6, 2024 (inception) to September 30, 2024 to $14.7 million for the nine months ended September 30, 2025. Stock-based compensation expense increased by $4.4 million due to the increase in employee awards and $2.0 million due to an increase in Paruka warrant liability under the Option Agreements. Other research and development expenses increased by $2.2 million, from $0.9 million for the period from February 6, 2024 (inception) to September 30, 2024 to $3.1 million for the nine months ended September 30, 2025, primarily due to facilities and allocated overhead expenses as we commenced using our leased Menlo Park office space from June 2024 and Waltham office from April 2025, as well as increase in our research and development employee count.
Previous wording
Personnel-related expenses increased by $4.8 million, from $2.2 million for the period from February 6, 2024 (inception) to June 30, 2024 to $7.0 million for the six months ended June 30, 2025, as a result of continued hiring of executives and administrative employees. Stock-based compensation expense was $0.2 million and $3.6 million for the period from February 6, 2024 (inception) to June 30, 2024 and for the six months ended June 30, 2025, respectively.
Current wording
Personnel-related expenses increased by $6.2 million, from $4.6 million for the period from February 6, 2024 (inception) to September 30, 2024 to $10.8 million for the nine months ended September 30, 2025, as a result of continued hiring of executives and administrative employees. Stock-based compensation expense was $1.5 million and $5.4 million for the period from February 6, 2024 (inception) to September 30, 2024 and for the nine months ended September 30, 2025, respectively.
Previous wording
Expenses related to professional and consulting services remained relatively consistent at $2.1 million for the period from February 6, 2024 (inception) to June 30, 2024 compared to $2.1 million for the six months ended June 30, 2025.
Current wording
Expenses related to professional and consulting services increased by $0.5 million, from $2.9 million for the period from February 6, 2024 (inception) to September 30, 2024 compared to $3.4 million for the nine months ended September 30, 2025, due to higher spending on accounting, audit, and legal fees.
Previous wording
Interest income from cash equivalents and marketable securities was $7.9 million for the six months ended June 30, 2025. No interest income was recorded for the period from February 6, 2024 (inception) to June 30, 2024.
Current wording
Interest income from cash equivalents and marketable securities was $11.8 million for the nine months ended September 30, 2025. Interest income from money market funds was $1.3 million for the period from February 6, 2024 (inception) to September 30, 2024.
Previous wording
No interest expense was recorded during the six months ended June 30, 2025. Interest expense was $1.0 million for the period from February 6, 2024 (inception) to June 30, 2024 relating to the Convertible Note issued to Fairmount in March 2024.
Current wording
No interest expense was recorded during the nine months ended September 30, 2025. Interest expense was $1.5 million for the period from February 6, 2024 (inception) to September 30, 2024 relating to the Convertible Note issued to Fairmount in March 2024.
Previous wording
As of June 30, 2025, we had $351.5 million of cash, cash equivalents, and marketable securities.
Current wording
As of September 30, 2025, we had $500.9 million of cash, cash equivalents, and marketable securities.
Previous wording
Since our inception, we have incurred significant operating losses and negative cash flow from operations. We expect to incur significant expenses and operating losses for the foreseeable future as we continue the pre-clinical and clinical development of our programs and our early-stage research activities. We have not yet commercialized any products, and we do not expect to generate revenue from sales of products for several years, if at all. Through June 30, 2025, we had funded our operations primarily with proceeds from issuances of convertible preferred stock, common stock, a convertible note, and pre-funded warrants. In March 2024, we received $2.9 million in net proceeds from the issuance of Pre-Merger Oruka Series A Preferred Stock and $25.0 million in gross proceeds from the issuance of the Convertible Note, both of which were related party transactions. In August 2024, we raised approximately $228.0 million in net proceeds from Pre-Closing Financing and received $4.9 million in cash from ARCA upon consummation of the Merger. In September 2024, we received approximately $188.7 million in net proceeds from the issuance of common stock, Company Series A Preferred Stock, and pre-funded warrants in connection with the PIPE Financing.
Current wording
Since our inception, we have incurred significant operating losses and negative cash flow from operations. We expect to incur significant expenses and operating losses for the foreseeable future as we continue the pre-clinical and clinical development of our programs and our early-stage research activities. We have not yet commercialized any products, and we do not expect to generate revenue from sales of products for several years, if at all. Through September 30, 2025, we had funded our operations primarily with proceeds from issuances of convertible preferred stock, common stock, a convertible note, and pre-funded warrants.
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
From February 6, 2024 (inception) to June 30, 2024, net cash used in operating activities was $11.2 million, which was primarily attributable to a net loss of $29.3 million, partially offset by non-cash charges of $0.8 million and net cash provided by changes in operating activities of $17.3 million. Non-cash charges consisted of a $0.8 million increase in stock-based compensation expense. Net cash provided by changes in our operating activities primarily consisted of a $15.4 million increase in related parties accounts payable and other current liabilities, $2.0 million increase in accounts payable, $1.0 million increase in accrued interest, related party, $0.6 million increase in accrued expenses and other current liabilities, partially offset by a $1.7 million increase in prepaid expenses and other current assets.
Current wording
From February 6, 2024 (inception) to September 30, 2024, net cash used in operating activities was $39.0 million, which was primarily attributable to a net loss of $57.9 million, offset by non-cash charges of $11.3 million and net cash provided by changes in operating activities of $7.6 million. Non-cash charges primarily consisted of a $9.8 million increase in stock-based compensation expense (primarily from the Paruka Warrant Obligation) and $1.5 million of non-cash interest expense. Net cash provided by changes in our operating activities primarily consisted of a $1.6 million increase in accounts payable, $1.7 million increase in accrued expenses and other current liabilities, $6.4 million increase in related parties accounts payable and other current liabilities, partially offset by a $2.0 million increase in prepaid expenses and other current assets.
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, offset by $152.3 million in purchases 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, 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 from the 2025 PIPE Financing and $0.1 million proceeds from the issuance of shares of common stock in connection with purchases under our employee stock purchase plan.
Previous wording
From February 6, 2024 (inception) to June 30, 2024, net cash provided by financing activities was $26.3 million, consisting of $2.9 million of net proceeds from the issuance of Pre-Merger Oruka Series A Preferred Stock and $25.0 million of net proceeds from the issuance of the Convertible Note, partially offset by $1.6 million of payments in deferred offering costs.
Current wording
From February 6, 2024 (inception) to September 30, 2024, net cash provided by financing activities was $450.1 million, consisting of $228.1 million of net proceeds from the Pre-Closing Financing, $189.1 million of net proceeds from the 2024 PIPE Financing, $25.0 million of net proceeds from the issuance of the Convertible Note, $4.9 million of cash acquired in connection with the reverse recapitalization, and $2.9 million of net proceeds from the issuance of Series B Preferred Stock
Rearranged current paragraphs (2)
Current report — wording carried from elsewhere
On September 17, 2025, we entered into a Securities Purchase Agreement (the “2025 Securities Purchase Agreement”) for a private placement (the “2025 PIPE Financing”) with certain institutional and accredited investors. The closing of the 2025 PIPE Financing occurred on September 19, 2025.
Current report — wording carried from elsewhere
Pursuant to the 2025 Securities Purchase Agreement, the investors purchased an aggregate of 10,933,405 shares of Company Common Stock at a purchase price of $15.00 per share, and pre-funded warrants to purchase an aggregate of 1,066,666 shares of Company Common Stock at a purchase price of $14.999 per pre-funded warrant, for aggregate net proceeds of approximately $169.6 million (net of issuance costs of $10.4 million).
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
We initiated the dosing of healthy volunteers in a Phase 1 trial of ORKA-001 in the fourth quarter of 2024. We expect to share interim data from the first-in-human trial in healthy volunteers, including initial pharmacokinetic data, at the European Academy of Dermatology & Venereology (EADV) Congress in September 2025.