ORKA
Oruka TherapeuticsFDocument history
Earnings documents stored for ORKA.
Investor releaseQuarter not tagged2026-05-14Oruka Therapeutics Reports First Quarter 2026 Financial Results and Provides Corporate Update
GlobeNewswire
Oruka Therapeutics Reports First Quarter 2026 Financial Results and Provides Corporate Update
ORKA-001 EVERLAST-A 16-week data showed 63.5% PASI 100 rate and a favorable tolerability profile, with longer-term data expected in 2H 2026 ORCA-SURGE Phase 2 trial of ORKA-002 in psoriasis initiated with data expected 2027 Post-offering cash, cash equivalents and marketable securities expected to fund Company through BLA for ORKA-001 MENLO PARK, Calif., May 13, 2026 (GLOBE NEWSWIRE) -- Oruka Therapeutics, Inc. (“Oruka”) (Nasdaq: ORKA), a clinical-stage biotechnology company developing novel biologics designed to set a new standard for the treatment of chronic skin diseases including plaque psoriasis (PsO), today reported first quarter 2026 financial results and provided a corporate update. “This was an important period for our company as we saw interim data for ORKA-001 that hit the upper end of our expectations on all aspects,” said Lawrence Klein, PhD, Chief Executive Officer of Oruka. “Based on this data we were able to strengthen our balance sheet and provide runway through completion of late-stage development for that program. We’re looking forward to multiple readouts coming in 2026 and 2027, including additional data from ORKA-001 and the beginning of our readouts for ORKA-002 as well.” First Quarter 2026 and Recent Business and Pipeline Updates ORKA-001: A novel half-life extended IL-23p19 monoclonal antibody In April 2026, the Company presented positive data from its EVERLAST-A trial in moderate-to-severe PsO showing 40 of 63 (63.5%) participants treated with ORKA-001 achieved PASI 100 at Week 16. 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 well tolerated with a safety profile similar to placebo and consistent with prior IL-23p19 inhibitors. Also in April 2026, the Company presented updated pharmacokinetics (PK) and pharmacodynamics (PD) data from the Phase 1 trial of ORKA-001, which continue to support the potential for annual dosing. Following a single 600 mg dose, ORKA-001 concentrations remained well above effective trough levels for an entire year, with sustained inhibition of IL-23 pathway signaling observed throughout that time period. Oruka plans to share longer-term data from EVERLAST-A, including efficacy at Week 28 for all patients and 52-week follow-up for a subset of the cohort, in the second half of 2026. EVERLAST-B, a…Read full documentShow less
ORKA-001 EVERLAST-A 16-week data showed 63.5% PASI 100 rate and a favorable tolerability profile, with longer-term data expected in 2H 2026 ORCA-SURGE Phase 2 trial of ORKA-002 in psoriasis initiated with data expected 2027 Post-offering cash, cash equivalents and marketable securities expected to fund Company through BLA for ORKA-001 MENLO PARK, Calif., May 13, 2026 (GLOBE NEWSWIRE) -- Oruka Therapeutics, Inc. (“Oruka”) (Nasdaq: ORKA), a clinical-stage biotechnology company developing novel biologics designed to set a new standard for the treatment of chronic skin diseases including plaque psoriasis (PsO), today reported first quarter 2026 financial results and provided a corporate update. “This was an important period for our company as we saw interim data for ORKA-001 that hit the upper end of our expectations on all aspects,” said Lawrence Klein, PhD, Chief Executive Officer of Oruka. “Based on this data we were able to strengthen our balance sheet and provide runway through completion of late-stage development for that program. We’re looking forward to multiple readouts coming in 2026 and 2027, including additional data from ORKA-001 and the beginning of our readouts for ORKA-002 as well.” First Quarter 2026 and Recent Business and Pipeline Updates ORKA-001: A novel half-life extended IL-23p19 monoclonal antibody In April 2026, the Company presented positive data from its EVERLAST-A trial in moderate-to-severe PsO showing 40 of 63 (63.5%) participants treated with ORKA-001 achieved PASI 100 at Week 16. 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 well tolerated with a safety profile similar to placebo and consistent with prior IL-23p19 inhibitors. Also in April 2026, the Company presented updated pharmacokinetics (PK) and pharmacodynamics (PD) data from the Phase 1 trial of ORKA-001, which continue to support the potential for annual dosing. Following a single 600 mg dose, ORKA-001 concentrations remained well above effective trough levels for an entire year, with sustained inhibition of IL-23 pathway signaling observed throughout that time period. Oruka plans to share longer-term data from EVERLAST-A, including efficacy at Week 28 for all patients and 52-week follow-up for a subset of the cohort, in the second half of 2026. EVERLAST-B, a Phase 2b trial of ORKA-001 in moderate-to-severe PsO, is progressing well with North American and European sites active. Initial data from this study is expected in 2027 and Week 16 data is intended to support Phase 3 initiation. ORKA-002: A novel half-life extended IL-17A/F monoclonal antibody In March 2026, the Company announced the initiation of ORCA-SURGE, a Phase 2 trial of ORKA-002 in moderate-to-severe PsO. That study is progressing well with data anticipated in 2027. In January 2026, Oruka announced positive interim Phase 1 data demonstrating a half-life of approximately 75–80 days and pharmacokinetic modeling supporting twice-yearly maintenance dosing in PsO and quarterly dosing in hidradenitis suppurativa (HS). The Company is on track to initiate ORCA-SPLASH, a Phase 2 trial of ORKA-002 in moderate-to-severe HS, in the second half of 2026. Additional updates In April 2026, the Company announced the pricing of an upsized $700 million public offering. Proceeds from this offering, including existing cash, are expected to fund operations through an anticipated BLA filing for ORKA-001 and continued development of ORKA-002. In May 2026, the Company announced a collaboration and license agreement with Halozyme to develop ORKA-001 with Hypercon™ technology. The agreement provides exclusive rights for IL-23p19 in psoriatic disease and an option for one additional target. This collaboration has the potential to further enhance the product profile Oruka can offer to patients over time. First Quarter 2026 Financial Results Cash Position: As of March 31, 2026, Oruka had cash, cash equivalents, and marketable securities of $496.0 million. Net cash used in operating activities was $23.6 million for the first quarter of 2026 compared to $20.9 million for the first quarter of 2025. Research and Development (R&D) Expenses: R&D expenses were $29.1 million for the first quarter of 2026, compared to $19.9 million for the first quarter of 2025. The increase was primarily related to additional clinical trials and associated costs of Oruka’s programs and higher employee compensation expenses, including stock-based compensation from higher headcount. General and Administrative (G&A) Expenses: G&A expenses were $7.3 million for the first quarter of 2026, compared to $5.2 million for the first quarter of 2025. The increase was primarily related to employee compensation-related expenses, including stock-based compensation from higher headcount. Other income, net: Other income, net was $4.6 million for the first quarter of 2026, compared to $4.1 million for the first quarter of 2025. The increase was primarily due to interest earned on higher cash and marketable securities balances. Net Loss: Net loss was $31.8 million and $21.0 million for the first quarters of 2026 and 2025, respectively. About Oruka Therapeutics Oruka Therapeutics is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice a year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit www.orukatx.com and follow Oruka on LinkedIn. Forward Looking Statements Certain statements in this press release, other than purely historical information, may constitute “forward-looking statements” within the meaning of the federal securities laws, including for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements relating to Oruka’s expectations, hopes, beliefs, intentions or strategies regarding the future of its pipeline and business including, without limitation, Oruka’s ability to achieve the expected benefits or opportunities with respect to ORKA-001 and ORKA-002, including timelines to clinical and data release milestones, the planned design, initiation, progress and results of its clinical studies (including EVERLAST-A, EVERLAST-B, ORCA-SURGE and ORCA-SPLASH), the potential dosing intervals of ORKA-001 and ORKA-002, the anticipated half-life and pharmacokinetic profile of ORKA-002, the potential benefits of its collaboration with Halozyme, and Oruka’s expected cash runway and ability to fund operations through an anticipated BLA filing for ORKA-001. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting Oruka will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond Oruka’s control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, those uncertainties and factors described under the heading “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in Oruka’s most recent filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Should one or more of these risks or uncertainties materialize, or should any of Oruka’s assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth therein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein and in Oruka’s SEC filings. Oruka does not undertake or accept any duty to make any updates or revisions to any forward-looking statements. Investor Contact: Alan Lada (650)-606-7911 [email protected]
Investor releaseQuarter not tagged2026-04-30Oruka Therapeutics (ORKA) Reports Positive Phase 2a Results for Psoriasis Treatment ORKA-001
Insider Monkey
Oruka Therapeutics (ORKA) Reports Positive Phase 2a Results for Psoriasis Treatment ORKA-001
Oruka Therapeutics (NASDAQ:ORKA) is one of the small-cap stocks that are on fire right now. On April 27, Oruka Therapeutics announced positive interim results from its EVERLAST-A Phase 2a trial for ORKA-001, a long-acting monoclonal antibody targeting moderate-to-severe plaque psoriasis. The study met its primary endpoint, with 63.5% of patients achieving complete skin clearance (PASI 100) by Week 16. These efficacy rates are numerically higher than those of other current IL-23p19 inhibitors, placing ORKA-001 among the top-performing treatments for this condition. The safety profile for ORKA-001 remained favorable and consistent with its drug class, with no serious treatment-emergent adverse events reported in the treated group. Most side effects were mild, with upper respiratory tract infections being the only common event observed. Crucially, updated data from earlier phases suggest the drug maintains effective concentrations for an entire year after a single dose, reinforcing the potential for once-yearly dosing, an improvement over current treatment frequencies. Following these results, Oruka Therapeutics (NASDAQ:ORKA) plans to release longer-term follow-up data, including 52-week results for a subset of patients, in H2 2026. The company is also moving forward with its EVERLAST-B Phase 2b trial, with data expected in 2027. If successful, ORKA-001 could redefine the standard of care by offering high-level skin clearance with substantially fewer injections than existing biologics. Oruka Therapeutics (NASDAQ:ORKA) is a biopharmaceutical company developing next-generation biologics for chronic skin and inflammatory diseases. Its lead antibody programs target plaque psoriasis and psoriatic arthritis, aiming to provide complete disease clearance with maintenance dosing as infrequent as once or twice a year. While we acknowledge the potential of ORKA as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 33 Stocks That Should Double in 3 Years and Cathie Wood 2026 Portfolio: 10 Best Stocks to Buy. Disclosure: None. Follow Insider Monkey on Google News.
Investor releaseQuarter not tagged2026-03-13Oruka Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Corporate Update
GlobeNewswire
Oruka Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Corporate Update
ORKA-001 EVERLAST-A 16-week data now expected in 2Q 2026 following rapid enrollment, with longer-term follow-up data expected in 2H 2026 ORCA-SURGE Phase 2 trial of ORKA-002 in psoriasis initiated with data expected 2027 $479.6 million in cash, cash equivalents and marketable securities MENLO PARK, Calif., March 12, 2026 (GLOBE NEWSWIRE) -- Oruka Therapeutics, Inc. (“Oruka”) (Nasdaq: ORKA), a clinical-stage biotechnology company developing novel biologics designed to set a new standard for the treatment of chronic skin diseases including plaque psoriasis (PsO), today reported fourth quarter and full year 2025 financial results and provided a corporate update. “We are very pleased with the progress of both our co-lead programs as we advance into what could be a transformative year for our company,” said Lawrence Klein, PhD, Chief Executive Officer of Oruka. “Given strong site engagement and enthusiasm, EVERLAST-A completed enrollment in December 2025, enabling us to bring our initial data release into the second quarter of 2026. Meanwhile, we are excited to be starting our Phase 2 efforts with ORKA-002, which we believe could be a very impactful program in psoriatic disease and HS.” Fourth Quarter 2025 and Recent Business and Pipeline Updates ORKA-001: A novel half-life extended IL-23p19 monoclonal antibody Enrollment in EVERLAST-A was completed in December 2025. As a result, the Company now expects to report Week 16 data for all patients in the second quarter of 2026. In addition, the Company plans to provide longer-term data, including Week 28 for all patients and 52-week follow-up for a portion of the cohort in the second half of 2026. The first patients were dosed in EVERLAST-B in December 2025 and enrollment is ongoing. EVERLAST-B is evaluating multiple induction regimens of ORKA-001, with a primary endpoint of PASI 100 at Week 16. Data from EVERLAST-B is anticipated in 2027 and will be used to support initiation of a Phase 3 program. ORKA-002: A novel half-life extended IL-17A/F monoclonal antibody In February 2026, the Company initiated ORCA-SURGE, a Phase 2 trial designed to evaluate the safety and efficacy of ORKA-002 in moderate-to-severe PsO patients. The primary endpoint will be PASI 100 at Week 16. Maintenance dosing will evaluate the potential for twice-yearly dosing with ORKA-002. Data from ORCA-SURGE is anticipated in 2027. In January 2026, Or…Read full documentShow less
ORKA-001 EVERLAST-A 16-week data now expected in 2Q 2026 following rapid enrollment, with longer-term follow-up data expected in 2H 2026 ORCA-SURGE Phase 2 trial of ORKA-002 in psoriasis initiated with data expected 2027 $479.6 million in cash, cash equivalents and marketable securities MENLO PARK, Calif., March 12, 2026 (GLOBE NEWSWIRE) -- Oruka Therapeutics, Inc. (“Oruka”) (Nasdaq: ORKA), a clinical-stage biotechnology company developing novel biologics designed to set a new standard for the treatment of chronic skin diseases including plaque psoriasis (PsO), today reported fourth quarter and full year 2025 financial results and provided a corporate update. “We are very pleased with the progress of both our co-lead programs as we advance into what could be a transformative year for our company,” said Lawrence Klein, PhD, Chief Executive Officer of Oruka. “Given strong site engagement and enthusiasm, EVERLAST-A completed enrollment in December 2025, enabling us to bring our initial data release into the second quarter of 2026. Meanwhile, we are excited to be starting our Phase 2 efforts with ORKA-002, which we believe could be a very impactful program in psoriatic disease and HS.” Fourth Quarter 2025 and Recent Business and Pipeline Updates ORKA-001: A novel half-life extended IL-23p19 monoclonal antibody Enrollment in EVERLAST-A was completed in December 2025. As a result, the Company now expects to report Week 16 data for all patients in the second quarter of 2026. In addition, the Company plans to provide longer-term data, including Week 28 for all patients and 52-week follow-up for a portion of the cohort in the second half of 2026. The first patients were dosed in EVERLAST-B in December 2025 and enrollment is ongoing. EVERLAST-B is evaluating multiple induction regimens of ORKA-001, with a primary endpoint of PASI 100 at Week 16. Data from EVERLAST-B is anticipated in 2027 and will be used to support initiation of a Phase 3 program. ORKA-002: A novel half-life extended IL-17A/F monoclonal antibody In February 2026, the Company initiated ORCA-SURGE, a Phase 2 trial designed to evaluate the safety and efficacy of ORKA-002 in moderate-to-severe PsO patients. The primary endpoint will be PASI 100 at Week 16. Maintenance dosing will evaluate the potential for twice-yearly dosing with ORKA-002. Data from ORCA-SURGE is anticipated in 2027. In January 2026, Oruka announced positive interim Phase 1 data demonstrating a half-life of approximately 75–80 days and pharmacokinetic modeling supporting twice-yearly maintenance dosing in psoriasis and quarterly dosing in HS. The Company is on track to initiate a Phase 2 trial of ORKA-002 for the treatment of moderate-to-severe hidradenitis suppurativa (HS) in the second half of 2026. Additional updates In December 2025, the Company announced the addition of Chris Martin to its Board of Directors, adding significant commercial and business development expertise. Fourth Quarter and Full Year 2025 Financial Results Cash Position: As of December 31, 2025, Oruka had cash, cash equivalents and marketable securities of $479.6 million. Net cash used in operating activities was $22.6 million for the fourth quarter of 2025 and $88.2 million for the full year 2025 compared to $18.8 million for the fourth quarter of 2024 and $57.8 million for the period from February 6, 2024 (inception) to December 31, 2024. Research and Development (R&D) Expenses: R&D expenses were $27.6 million for the fourth quarter of 2025 and $100.6 million for the full year 2025, compared to $25.5 million for the fourth quarter of 2024 and $75.1 million for the period from February 6, 2024 (inception) to December 31, 2024. The increases were primarily related to additional clinical trials of Oruka’s programs. General and Administrative (G&A) Expenses: G&A expenses were $6.8 million for the fourth quarter of 2025 and $21.4 million for the full year 2025, compared to $4.8 million for the fourth quarter of 2024 and $13.1 million for the period from February 6, 2024 (inception) to December 31, 2024. The increases were primarily related to employee compensation-related expenses, including stock-based compensation from higher headcount. Other income, net: Other income, net was $4.8 million and $16.6 million for the fourth quarter and full year 2025, respectively, compared to $4.5 million for the fourth quarter of 2024 and $4.4 million for the period from February 6, 2024 (inception) to December 31, 2024. The increases were primarily related to interest earned on the Company’s cash and marketable securities. Net Loss: Net loss was $29.6 million for the fourth quarter of 2025 and $105.4 million for the full year 2025, compared to $25.8 million for the fourth quarter of 2024 and $83.7 million for the period from February 6, 2024 (inception) to December 31, 2024. About Oruka Therapeutics Oruka Therapeutics is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice a year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit www.orukatx.com and follow Oruka on LinkedIn. Forward Looking Statements Certain statements in this press release, other than purely historical information, may constitute “forward-looking statements” within the meaning of the federal securities laws, including for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements relating to Oruka’s expectations, hopes, beliefs, intentions or strategies regarding the future of its pipeline and business including, without limitation, Oruka’s ability to achieve the expected benefits or opportunities with respect to ORKA-001 and ORKA-002, including timelines to clinical and data release milestones, the details of its planned clinical studies, the potential dosing intervals of ORKA-001 and ORKA-002, the anticipated half-life of ORKA-002, as well as the Company’s cash runway. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting Oruka will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond Oruka’s control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, those uncertainties and factors described under the heading “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in Oruka’s most recent filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Should one or more of these risks or uncertainties materialize, or should any of Oruka’s assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth therein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein and in Oruka’s SEC filings. Oruka does not undertake or accept any duty to make any updates or revisions to any forward-looking statements. Investor Contact: Alan Lada (650)-606-7911 [email protected]
Investor releaseQuarter not tagged2025-11-13Oruka Therapeutics Reports Third Quarter 2025 Financial Results and Provides Corporate Update
GlobeNewswire
Oruka Therapeutics Reports Third Quarter 2025 Financial Results and Provides Corporate Update
ORKA-001 Phase 1 results presented at EADV show potential for once-per-year dosing, higher efficacy and off-treatment remission Over $500M cash and equivalents provides runway over one year past three key readouts: ORKA-001 Phase 2a and 2b (EVERLAST-A and -B), and ORKA-002 Phase 2 ORKA-002 Phase 1 trial ongoing, with data to be presented around YE 2025 ORKA-001 Phase 2a trial enrolling well with data expected 2H 2026 MENLO PARK, Calif., Nov. 12, 2025 (GLOBE NEWSWIRE) -- Oruka Therapeutics, Inc. (“Oruka”) (Nasdaq: ORKA), a clinical-stage biotechnology company developing novel biologics designed to set a new standard for the treatment of chronic skin diseases including plaque psoriasis (PsO), today reported third quarter 2025 financial results and provided a corporate update. “We had a very successful quarter where we released our first clinical data as a company and extended our cash runway beyond additional Phase 2 clinical readouts,” commented Lawrence Klein, PhD, Chief Executive Officer of Oruka. “We are seeing increased interest in both of our co-lead programs, with additional appreciation that each could become a very impactful medicine in psoriatic disease and beyond. We’re excited by our continued rapid progress advancing both ORKA-001 and -002 and look forward to sharing our first Phase 2 data in 2026.” Third Quarter Business and Pipeline Updates ORKA-001: a novel half-life extended IL-23p19 monoclonal antibody In September 2025, at the European Academy of Dermatology and Venerology (EADV) Congress, the Company presented interim Phase 1 results in a late-breaking oral session. ORKA-001 demonstrated a half-life of approximately 100 days, greater than three times that of risankizumab, and a Cmax that exceeded risankizumab at an equivalent dose, both of which increase the likelihood of achieving once-yearly dosing, higher efficacy, and extended off-treatment remissions. Single doses of ORKA-001 also showed complete and sustained inhibition of STAT3 signaling, a downstream marker of IL-23 activity. ORKA-001 was well tolerated across all dose levels, with a favorable safety profile consistent with the anti-IL-23 class. The study is ongoing. Enrollment is progressing well in EVERLAST-A, a randomized, double-blind, placebo-controlled Phase 2a trial of ORKA-001 in moderate to severe PsO. Additional details of the study design were presented in an oral present…Read full documentShow less
ORKA-001 Phase 1 results presented at EADV show potential for once-per-year dosing, higher efficacy and off-treatment remission Over $500M cash and equivalents provides runway over one year past three key readouts: ORKA-001 Phase 2a and 2b (EVERLAST-A and -B), and ORKA-002 Phase 2 ORKA-002 Phase 1 trial ongoing, with data to be presented around YE 2025 ORKA-001 Phase 2a trial enrolling well with data expected 2H 2026 MENLO PARK, Calif., Nov. 12, 2025 (GLOBE NEWSWIRE) -- Oruka Therapeutics, Inc. (“Oruka”) (Nasdaq: ORKA), a clinical-stage biotechnology company developing novel biologics designed to set a new standard for the treatment of chronic skin diseases including plaque psoriasis (PsO), today reported third quarter 2025 financial results and provided a corporate update. “We had a very successful quarter where we released our first clinical data as a company and extended our cash runway beyond additional Phase 2 clinical readouts,” commented Lawrence Klein, PhD, Chief Executive Officer of Oruka. “We are seeing increased interest in both of our co-lead programs, with additional appreciation that each could become a very impactful medicine in psoriatic disease and beyond. We’re excited by our continued rapid progress advancing both ORKA-001 and -002 and look forward to sharing our first Phase 2 data in 2026.” Third Quarter Business and Pipeline Updates ORKA-001: a novel half-life extended IL-23p19 monoclonal antibody In September 2025, at the European Academy of Dermatology and Venerology (EADV) Congress, the Company presented interim Phase 1 results in a late-breaking oral session. ORKA-001 demonstrated a half-life of approximately 100 days, greater than three times that of risankizumab, and a Cmax that exceeded risankizumab at an equivalent dose, both of which increase the likelihood of achieving once-yearly dosing, higher efficacy, and extended off-treatment remissions. Single doses of ORKA-001 also showed complete and sustained inhibition of STAT3 signaling, a downstream marker of IL-23 activity. ORKA-001 was well tolerated across all dose levels, with a favorable safety profile consistent with the anti-IL-23 class. The study is ongoing. Enrollment is progressing well in EVERLAST-A, a randomized, double-blind, placebo-controlled Phase 2a trial of ORKA-001 in moderate to severe PsO. Additional details of the study design were presented in an oral presentation at the EADV Congress. EVERLAST-A is designed to provide evidence of ORKA-001’s potential for yearly dosing, greater efficacy, and extended off-treatment remissions. The Company expects to share PASI 100 data at Week 16 for all patients, as well as response duration data out to approximately one year for some patients, in 2H 2026. Oruka plans to initiate a dose-ranging Phase 2b trial of ORKA-001, EVERLAST-B, in 1H 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 is PASI 100 at Week 16. To expedite development, EVERLAST-B dosing is projected to begin enrolling before the completion of EVERLAST-A. ORKA-002: a novel half-life extended IL-17A/F monoclonal antibody The Phase 1 trial of ORKA-002 is ongoing. The trial is a double-blind, placebo-controlled, single ascending dose study evaluating the safety, tolerability, and PK of ORKA-002 in approximately 24 healthy volunteers. The Company expects to share interim data from this trial, including initial PK data, around YE 2025. The Company intends to begin a Phase 2 trial of ORKA-002 in moderate-to-severe PsO in 1H 2026. The Company also is planning for a Phase 2 trial in hidradenitis suppurativa (HS), which is included in cash runway forecasts. Additional programs and updates The Company completed a $180M PIPE financing, extending runway over one year past three Phase 2 catalysts: the ORKA-001 Phase 2a and 2b studies (EVERLAST-A and -B), and the ORKA-002 Phase 2 study in PsO. ORKA-021 (ORKA-002 → ORKA-001): Oruka continues to advance a sequential combination regimen of ORKA-002 and ORKA-001, which could deliver rapid and deep responses with an ideal maintenance profile. ORKA-021 could create another opportunity for the Company to define the best possible regimen for the treatment of psoriatic disease. ORKA-003: The Company continues to progress ORKA-003 through preclinical development. Third Quarter 2025 Financial Results Cash Position: As of September 30, 2025, Oruka had available cash, cash equivalents, and marketable securities of $500.9 million. Net cash used in operating activities was $21.6 million for the third quarter of 2025. Research and Development (R&D) expenses: R&D expenses totaled $29.0 million and $25.7 million for the third quarters of 2025 and 2024, respectively. The increase was primarily related to employee compensation-related expenses, including stock-based compensation to support the Company’s plaque psoriasis programs. These expenses include $8.3 million and $7.8 million of non-cash stock-based compensation for the third quarters of 2025 and 2024, respectively, of which $6.6 million and $7.3 million, respectively, relate to Paruka warrant obligation. General and Administrative (G&A) expenses: G&A expenses totaled $5.1 million and $3.8 million for the third quarters of 2025 and 2024, respectively. The increases were primarily related to employee compensation-related expenses, including stock-based compensation, professional and consulting fees to support the growth in our operations, and costs associated with being a public company. Other income, net: Other income, net was $3.8 million and $0.8 million for the third quarters of 2025 and 2024, respectively. The increase is primarily due to higher interest income in the third quarter of 2025 from the Company’s investment in marketable securities. Net loss: Net loss totaled $30.3 million and $28.6 million for the third quarters of 2025 and 2024, respectively, which includes non-cash stock-based compensation of $10.2 million and $9.0 million for the third quarters of 2025 and 2024, respectively Shares Outstanding: Oruka has approximately 67.1 million shares of the Company’s common stock and common stock equivalents issued and outstanding, including shares of common stock underlying pre-funded warrants and non-voting convertible preferred stock. About Oruka Therapeutics Oruka Therapeutics is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice a year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit www.orukatx.com and follow Oruka on LinkedIn. Forward Looking Statements Certain statements in this press release, other than purely historical information, may constitute “forward-looking statements” within the meaning of the federal securities laws, including for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements relating to Oruka’s expectations, hopes, beliefs, intentions or strategies regarding the future of its pipeline and business including, without limitation, Oruka’s ability to achieve the expected benefits or opportunities with respect to ORKA-001, ORKA-002 and ORKA-021, including timelines to clinical and data release milestones, trial and site initiation timelines, and the details of its planned clinical studies, as well as the potential exposures and dosing interval of ORKA-001 and cash runway. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting Oruka will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond Oruka's control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, those uncertainties and factors described under the heading “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in Oruka’s most recent filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Should one or more of these risks or uncertainties materialize, or should any of Oruka’s assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth therein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein and in Oruka’s SEC filings. Oruka does not undertake or accept any duty to make any updates or revisions to any forward-looking statements. Investor Contact: Alan Lada (650)-606-7911 [email protected]
Investor releaseQuarter not tagged2025-09-30MoonLake Crashes 90% On Mixed Results For Skin Disease Treatment
Investor's Business Daily
MoonLake Crashes 90% On Mixed Results For Skin Disease Treatment
MoonLake Immunotherapeutics stock crashed Monday after the company posted mixed results for its highly anticipated skin disease drug.
Investor releaseQuarter not tagged2025-09-17Oruka Therapeutics Announces Positive Interim Phase 1 Results for ORKA-001
GlobeNewswire
Oruka Therapeutics Announces Positive Interim Phase 1 Results for ORKA-001
Half-life of approximately 100 days increases likelihood of once-per-year dosing Pharmacokinetic profile supports the ability to achieve exposures that could lead to higher efficacy and extended off-treatment remissions Well tolerated with a favorable safety profile consistent with the IL-23p19 class EVERLAST-A Phase 2a trial enrollment ongoing with data expected 2H 2026 MENLO PARK, Calif., Sept. 17, 2025 (GLOBE NEWSWIRE) -- Oruka Therapeutics, Inc. (“Oruka”) (Nasdaq: ORKA), a biotechnology company developing novel biologics designed to set a new standard for the treatment of chronic skin diseases including plaque psoriasis (PsO), today announced interim data from its Phase 1 trial of ORKA-001, the Company’s long-acting IL-23p19 antibody, in a late-breaking abstract at the European Academy of Dermatology and Venerology (EADV) Congress in Paris, France. These results, as well as additional details on the EVERLAST-A trial design, will be presented in two oral presentations at the conference. “ORKA-001's approximately 100-day half-life exceeded our expectations and has the potential to enable multiple ‘upside’ scenarios for the program,” said Lawrence Klein, PhD, CEO of Oruka. “We are increasingly confident that ORKA-001 can redefine the standard of care in this important disease. I’m very pleased with how quickly our team has progressed this program and by the enthusiasm we are hearing from investigators and patients.” Interim results from the Phase 1 trial support the potential for ORKA-001 to change the PsO treatment paradigm. The ongoing EVERLAST-A Phase 2a trial is designed to test whether ORKA-001 can enable annual dosing, higher rates of skin clearance than standard of care, and long-term off-treatment remissions. Oruka expects to present initial data from EVERLAST-A in 2H 2026. Key Phase 1 Interim Findings The Phase 1 trial is a first-in-human, randomized, double-blind, placebo-controlled trial designed to evaluate the safety and pharmacokinetics (PK) of ORKA-001 in healthy volunteers. The study enrolled 24 healthy adult participants into three single ascending subcutaneous dose cohorts of 300 mg, 600 mg, and 1200 mg. Interim results from the Phase 1 trial include: PK: ORKA-001 showed a half-life of approximately 100 days, greater than three times that of risankizumab, and a Cmax that exceeded risankizumab at an equivalent dose, based on previously repo…Read full documentShow less
Half-life of approximately 100 days increases likelihood of once-per-year dosing Pharmacokinetic profile supports the ability to achieve exposures that could lead to higher efficacy and extended off-treatment remissions Well tolerated with a favorable safety profile consistent with the IL-23p19 class EVERLAST-A Phase 2a trial enrollment ongoing with data expected 2H 2026 MENLO PARK, Calif., Sept. 17, 2025 (GLOBE NEWSWIRE) -- Oruka Therapeutics, Inc. (“Oruka”) (Nasdaq: ORKA), a biotechnology company developing novel biologics designed to set a new standard for the treatment of chronic skin diseases including plaque psoriasis (PsO), today announced interim data from its Phase 1 trial of ORKA-001, the Company’s long-acting IL-23p19 antibody, in a late-breaking abstract at the European Academy of Dermatology and Venerology (EADV) Congress in Paris, France. These results, as well as additional details on the EVERLAST-A trial design, will be presented in two oral presentations at the conference. “ORKA-001's approximately 100-day half-life exceeded our expectations and has the potential to enable multiple ‘upside’ scenarios for the program,” said Lawrence Klein, PhD, CEO of Oruka. “We are increasingly confident that ORKA-001 can redefine the standard of care in this important disease. I’m very pleased with how quickly our team has progressed this program and by the enthusiasm we are hearing from investigators and patients.” Interim results from the Phase 1 trial support the potential for ORKA-001 to change the PsO treatment paradigm. The ongoing EVERLAST-A Phase 2a trial is designed to test whether ORKA-001 can enable annual dosing, higher rates of skin clearance than standard of care, and long-term off-treatment remissions. Oruka expects to present initial data from EVERLAST-A in 2H 2026. Key Phase 1 Interim Findings The Phase 1 trial is a first-in-human, randomized, double-blind, placebo-controlled trial designed to evaluate the safety and pharmacokinetics (PK) of ORKA-001 in healthy volunteers. The study enrolled 24 healthy adult participants into three single ascending subcutaneous dose cohorts of 300 mg, 600 mg, and 1200 mg. Interim results from the Phase 1 trial include: PK: ORKA-001 showed a half-life of approximately 100 days, greater than three times that of risankizumab, and a Cmax that exceeded risankizumab at an equivalent dose, based on previously reported risankizumab data. These properties increase the likelihood of achieving once-yearly maintenance dosing and demonstrate comparable exposures to the KNOCKOUT study, which could lead to best-in-class rates of skin clearance and extended off-treatment remissions. Pharmacodynamics (PD): 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). Safety: ORKA-001 was well tolerated at all dose levels, with a favorable safety profile consistent with the anti-IL-23 class. There were no severe treatment-emergent adverse events (TEAEs) or serious adverse events. The only TEAEs to occur in more than two subjects were headache, upper respiratory tract infections, and transient erythema at the injection site. The study remains blinded, and all subjects remain on study. EVERLAST Phase 2 Trials of ORKA-001 in Plaque Psoriasis The ongoing EVERLAST-A trial is a randomized, double-blind, placebo-controlled Phase 2a trial designed to evaluate the safety and efficacy of a single dose level of ORKA-001 in moderate-to-severe PsO patients. Enrollment and dosing at sites across the U.S. and Canada are currently progressing well, and the Company expects to share initial data from EVERLAST-A in 2H 2026. Data presented at that time is expected to include PASI 100 at Week 16 for all patients and preliminary durability data that could show the potential for yearly dosing and off-treatment remissions. EVERLAST-A will enroll approximately 80 patients randomized 3:1 to receive 600 mg ORKA-001 at Week 0 and 4 or matching placebo. The primary endpoint is PASI 100 at Week 16. ORKA-001 exposures are expected to match or exceed exposures in the KNOCKOUT study, testing whether higher antibody exposures can lead to greater efficacy. At Week 28, patients who have achieved PASI 100, or completely clear skin, will be randomized 2:1 to an arm where either (1) they do not receive another dose until disease recurrence or (2) they receive 300 mg ORKA-001 every six months. The “no-dose” arm will evaluate the possibility of both yearly dosing and extended off-treatment remissions (defined in the literature as clear skin over one year from last administration of a therapeutic). Patients who have not achieved PASI 100 at Week 28 will receive 300 mg ORKA-001 every six months. At Week 16, patients receiving placebo will cross over to 600 mg ORKA-001 at Week 16 and 20, followed by once-yearly dosing of ORKA-001, providing additional data on the efficacy of yearly dosing. In addition, Oruka expects to initiate a dose-ranging Phase 2b trial of ORKA-001 in moderate-to-severe PsO patients, EVERLAST-B, in 1H 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 is PASI 100 at Week 16. To expedite development, EVERLAST-B dosing is projected to begin enrolling before the completion of EVERLAST-A. Details of the oral presentations at EADV: Phase 1 Clinical Data of ORKA-001, a Novel Half-Life Extended IL-23p19 Monoclonal Antibody with Potential for Once-Yearly Dosing in Plaque Psoriasis Author: Dr. James Krueger Presentation ID: D2T01.4D Late-Breaking Presentation: Thursday, September 18, 16:45-17:00 CET Location: Paris Nord EVERLAST-A: A Phase 2a Study Design of ORKA-001, a Novel Half-Life Extended IL-23p19 Monoclonal Antibody for Plaque Psoriasis Author: Dr. Andrew Blauvelt Presentation ID: FC02.1l Oral Presentation: Thursday, September 18, 11:35-11:45 CET Location: W05-W06 About ORKA-001 ORKA-001 is a novel, subcutaneously administered, half-life extended monoclonal antibody targeting IL-23p19. Inhibitors of IL-23p19 have become the preferred first-line therapy for patients with moderate-to-severe PsO given their strong efficacy and safety profile. Currently approved therapies are dosed four to six times per year and deliver PASI 100, or fully clear skin, for less than half of patients after four months. ORKA-001 has the potential to be dosed just once or twice per year and is designed to achieve higher exposures than currently marketed IL-23p19 antibodies, which could lead to higher rates of disease clearance and extended off-treatment remissions. ORKA-001 is designed to match the validated biology of risankizumab by binding to a similar epitope with similar affinity, but has a significantly extended half-life of approximately 100 days. About Oruka Therapeutics Oruka Therapeutics is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice a year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit www.orukatx.com and follow Oruka on LinkedIn. Forward-Looking Statements Certain statements in this press release, other than purely historical information, may constitute “forward-looking statements” within the meaning of the federal securities laws, including for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements relating to Oruka’s expectations, hopes, beliefs, intentions or strategies regarding the future of its pipeline and business including, without limitation, Oruka’s ability to achieve the expected benefits or opportunities with respect to ORKA-001, including its anticipated half-life, potential dosing intervals, ability to deliver off-treatment remissions, anticipated rates of disease clearance, and safety and tolerability profile; the competitive outlook; and anticipated trial design, enrollment targets and timelines to clinical development and data release milestones for ORKA-001. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting Oruka will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond Oruka's control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties inherent in the drug development process, including risks related to the design and conduct of clinical trials; risks that the outcome of preclinical testing and early clinical trials may not be predictive of the success of later clinical trials, and interim results of a clinical trial do not necessarily predict final results; risks related to the regulatory approval process and the timing of regulatory filings; risks related to Oruka’s ability to successfully establish, protect and defend its intellectual property; risks related to other matters that could affect the sufficiency of the company’s capital resources to fund operations; and changes in the competitive landscape. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, see the uncertainties and factors described under the heading “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in Oruka’s most recent filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K, its Quarterly Reports on Form 10-Q and subsequent filings with the SEC. Should one or more of these risks or uncertainties materialize, or should any of Oruka’s assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth therein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein and in Oruka’s SEC filings. Oruka does not undertake or accept any duty to make any updates or revisions to any forward-looking statements. Investor Contact: Alan Lada (650)-606-7911 [email protected]
Investor releaseQuarter not tagged2025-08-12Oruka Therapeutics Reports Second Quarter 2025 Financial Results and Provides Corporate Update
GlobeNewswire
Oruka Therapeutics Reports Second Quarter 2025 Financial Results and Provides Corporate Update
First patients dosed in the EVERLAST-A Phase 2a trial of ORKA-001, with data expected in 2H 2026 ORKA-001 Phase 1 data and EVERLAST-A design to be presented at EADV in September 2025 ORKA-002 Phase 1 trial ongoing, with data to be presented around YE 2025 MENLO PARK, Calif., Aug. 11, 2025 (GLOBE NEWSWIRE) -- Oruka Therapeutics, Inc. (“Oruka”) (Nasdaq: ORKA), a clinical-stage biotechnology company developing novel biologics designed to set a new standard for the treatment of chronic skin diseases including plaque psoriasis, today reported second quarter 2025 financial results and provided a corporate update. “We are very pleased to have initiated our EVERLAST-A study, and we expect nearly all our sites to be open and enrolling by the end of the month,” said Lawrence Klein, PhD, Chief Executive Officer of Oruka. “This study could demonstrate three different aspects of ORKA-001’s differentiation – an ultra-long dosing interval, higher efficacy than other IL-23 inhibitors, and the potential for off-treatment remissions. Together with our ORKA-002 program and ORKA-021 sequential combination that are following close behind, we are confident we can have the best biologic regimens in psoriatic disease, an area that continues to reward innovation in biologics.” Second Quarter Business and Pipeline Updates ORKA-001: a novel half-life extended IL-23p19 monoclonal antibody Enrollment is ongoing in EVERLAST-A following clearance from both the U.S. FDA and Health Canada in July, and the first patients have been dosed in the study. EVERLAST-A is a randomized, double-blind, placebo-controlled Phase 2a trial designed to enroll approximately 80 patients with moderate-to-severe plaque psoriasis. Patients will be randomized 3:1 to receive ORKA-001 or placebo with a primary endpoint of PASI 100 at Week 16. At Week 28, patients who have achieved PASI 100, or completely clear skin, will be randomized 2:1 to either (1) an arm where they do not receive another dose until disease recurs or (2) ORKA-001 every six months. This “no-dose” arm will provide evidence for both yearly dosing and the potential for extended off-treatment remissions. Additional details on the EVERLAST-A design will be presented at the European Academy of Dermatology and Venereology (EADV) Congress in September. The Company expects to share efficacy and response duration data from EVERLAST-A in 2H 2026. Psoriasis…Read full documentShow less
First patients dosed in the EVERLAST-A Phase 2a trial of ORKA-001, with data expected in 2H 2026 ORKA-001 Phase 1 data and EVERLAST-A design to be presented at EADV in September 2025 ORKA-002 Phase 1 trial ongoing, with data to be presented around YE 2025 MENLO PARK, Calif., Aug. 11, 2025 (GLOBE NEWSWIRE) -- Oruka Therapeutics, Inc. (“Oruka”) (Nasdaq: ORKA), a clinical-stage biotechnology company developing novel biologics designed to set a new standard for the treatment of chronic skin diseases including plaque psoriasis, today reported second quarter 2025 financial results and provided a corporate update. “We are very pleased to have initiated our EVERLAST-A study, and we expect nearly all our sites to be open and enrolling by the end of the month,” said Lawrence Klein, PhD, Chief Executive Officer of Oruka. “This study could demonstrate three different aspects of ORKA-001’s differentiation – an ultra-long dosing interval, higher efficacy than other IL-23 inhibitors, and the potential for off-treatment remissions. Together with our ORKA-002 program and ORKA-021 sequential combination that are following close behind, we are confident we can have the best biologic regimens in psoriatic disease, an area that continues to reward innovation in biologics.” Second Quarter Business and Pipeline Updates ORKA-001: a novel half-life extended IL-23p19 monoclonal antibody Enrollment is ongoing in EVERLAST-A following clearance from both the U.S. FDA and Health Canada in July, and the first patients have been dosed in the study. EVERLAST-A is a randomized, double-blind, placebo-controlled Phase 2a trial designed to enroll approximately 80 patients with moderate-to-severe plaque psoriasis. Patients will be randomized 3:1 to receive ORKA-001 or placebo with a primary endpoint of PASI 100 at Week 16. At Week 28, patients who have achieved PASI 100, or completely clear skin, will be randomized 2:1 to either (1) an arm where they do not receive another dose until disease recurs or (2) ORKA-001 every six months. This “no-dose” arm will provide evidence for both yearly dosing and the potential for extended off-treatment remissions. Additional details on the EVERLAST-A design will be presented at the European Academy of Dermatology and Venereology (EADV) Congress in September. The Company expects to share efficacy and response duration data from EVERLAST-A in 2H 2026. Psoriasis trials historically have low placebo rates and high reproducibility across phases of development, making this Phase 2a readout particularly impactful for demonstrating ORKA-001’s differentiation. Oruka’s Phase 1 trial of ORKA-001 is ongoing, with dosing completed for all 24 subjects across three dose levels. The trial is a double-blind, placebo-controlled, single ascending dose study evaluating the safety, tolerability, and pharmacokinetics (PK) of ORKA-001. The Company will present data from this trial at EADV in September. ORKA-002: a novel half-life extended IL-17A/F monoclonal antibody The first participants were dosed in a Phase 1 trial of ORKA-002 in May, and the trial is ongoing. The trial is a double-blind, placebo-controlled, single ascending dose study evaluating the safety, tolerability, and PK of ORKA-002 in approximately 24 healthy volunteers. The Company expects to share interim data from this trial, including initial PK data, around YE 2025, and to initiate a Phase 2 trial in psoriasis in 1H 2026. Additional programs and updates Laura Sandler, who joined Oruka in 2024 as SVP of Operations, was promoted to Chief Operating Officer. ORKA-021 (ORKA-002 → ORKA-001): Oruka continues to advance a sequential combination regimen of ORKA-002 and ORKA-001, which could deliver rapid and deep responses with an ideal maintenance profile. ORKA-021 could create another opportunity for the Company to define the best possible regimen for the treatment of psoriatic disease. ORKA-003: The Company continues to progress ORKA-003 through preclinical development. Second Quarter 2025 Financial Results Cash Position: As of June 30, 2025, Oruka had available cash, cash equivalents, and marketable securities of $351.5 million. Net cash used in operating activities was $23.1 million for the second quarter of 2025. Research and Development (R&D) expenses: R&D expenses totaled $24.1 million and $18.7 million for the second quarters of 2025 and 2024, respectively. The increase was primarily related to employee compensation-related expenses, including stock-based compensation to support the Company’s plaque psoriasis programs. These expenses include $3.4 million and $0.5 million of non-cash stock-based compensation for the second quarters of 2025 and 2024, respectively. General and Administrative (G&A) expenses: G&A expenses totaled $4.3 million and $2.8 million for the second quarters of 2025 and 2024, respectively. The increases were primarily related to employee compensation-related expenses, including stock-based compensation, professional and consulting fees to support the growth in our operations, and costs associated with being a public company. Other income (expense), net: Other income, net for the second quarter of 2025 was $3.9 million, and other expense, net for second quarter of 2024 was ($0.8) million. Other income for the second quarter of 2025 relates to interest earned from the Company’s investment in marketable securities. Net loss: Net loss totaled $24.6 million and $22.2 million for the second quarters of 2025 and 2024, respectively, which includes non-cash stock-based compensation of $5.1 million and $0.7 million for the second quarters of 2025 and 2024, respectively Shares Outstanding: Oruka has approximately 55.1 million shares of the Company’s common stock and common stock equivalents issued and outstanding, including shares of common stock underlying pre-funded warrants and non-voting convertible preferred stock. About Oruka Therapeutics Oruka Therapeutics is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice a year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit www.orukatx.com and follow Oruka on LinkedIn. Forward Looking Statements Certain statements in this press release, other than purely historical information, may constitute “forward-looking statements” within the meaning of the federal securities laws, including for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements relating to Oruka’s expectations, hopes, beliefs, intentions or strategies regarding the future of its pipeline and business including, without limitation, Oruka’s ability to achieve the expected benefits or opportunities with respect to ORKA-001, ORKA-002 and ORKA-021, including timelines to clinical and data release milestones, trial and site initiation timelines, and the details of its planned clinical studies, as well as the potential exposures and dosing interval of ORKA-001. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting Oruka will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond Oruka's control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, those uncertainties and factors described under the heading “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in Oruka’s most recent filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and its registration statement on Form S-1. Should one or more of these risks or uncertainties materialize, or should any of Oruka’s assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth therein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein and in Oruka’s SEC filings. Oruka does not undertake or accept any duty to make any updates or revisions to any forward-looking statements. Investor Contact: Alan Lada (650)-606-7911 [email protected]
Investor releaseQuarter not tagged2025-05-15Oruka Therapeutics Reports First Quarter 2025 Financial Results and Provides Corporate Update
GlobeNewswire
Oruka Therapeutics Reports First Quarter 2025 Financial Results and Provides Corporate Update
Continued operational excellence leading to acceleration of multiple timelines: ORKA-001, targeting IL-23p19, Phase 1 trial dosing complete, with data expected in 3Q 2025 ORKA-001 Phase 2a initiation expected in 2H 2025, with efficacy readout expected in 2H 2026 that will provide multiple opportunities to show differentiation over standard of care ORKA-002, targeting IL-17A/F, Phase 1 initiation accelerated to 2Q 2025, with initial PK data now expected around YE 2025; data will support both ORKA-002 and ORKA-021 psoriasis studies Strong cash position of $373 million provides runway through 2027, over one year past anticipated ORKA-001 Phase 2a data in psoriasis MENLO PARK, Calif., May 14, 2025 (GLOBE NEWSWIRE) -- Oruka Therapeutics, Inc. (“Oruka”) (Nasdaq: ORKA), a clinical-stage biotechnology company developing novel biologics designed to set a new standard for the treatment of chronic skin diseases including plaque psoriasis, today reported first quarter 2025 financial results and provided a corporate update. “We are thrilled with the continued rapid progress we are making to advance our co-lead programs, which we think could set a new standard in the treatment of psoriatic disease,” said Lawrence Klein, PhD, Chief Executive Officer of Oruka. “We’re excited to soon have both of our co-lead programs, ORKA-001 and ORKA-002, in the clinic and release our first clinical data on ORKA-001. As we ramp up preparations for our first psoriasis studies, we are energized by the reception from physicians who clearly see the potential to advance the treatment paradigm in this important disease.” First Quarter Business and Pipeline Updates ORKA-001: a novel half-life extended IL-23p19 monoclonal antibody Oruka’s Phase 1 trial of ORKA-001 is progressing, with dosing completed for all 24 subjects across three dose levels. The trial is a double-blind, placebo-controlled, single ascending dose study evaluating the safety, tolerability, and pharmacokinetics (PK) of ORKA-001. The Company expects to share interim data from this trial, including initial PK data, in 3Q 2025 (previously 2H 2025). Based on PK modeling, the Company expects that a human half-life of 50 days or more will support dosing every six months whereas a half-life of 75 days or more could support dosing once per year. In comparison, currently approved IL-23p19 inhibitors require maintenance dosing every two or…Read full documentShow less
Continued operational excellence leading to acceleration of multiple timelines: ORKA-001, targeting IL-23p19, Phase 1 trial dosing complete, with data expected in 3Q 2025 ORKA-001 Phase 2a initiation expected in 2H 2025, with efficacy readout expected in 2H 2026 that will provide multiple opportunities to show differentiation over standard of care ORKA-002, targeting IL-17A/F, Phase 1 initiation accelerated to 2Q 2025, with initial PK data now expected around YE 2025; data will support both ORKA-002 and ORKA-021 psoriasis studies Strong cash position of $373 million provides runway through 2027, over one year past anticipated ORKA-001 Phase 2a data in psoriasis MENLO PARK, Calif., May 14, 2025 (GLOBE NEWSWIRE) -- Oruka Therapeutics, Inc. (“Oruka”) (Nasdaq: ORKA), a clinical-stage biotechnology company developing novel biologics designed to set a new standard for the treatment of chronic skin diseases including plaque psoriasis, today reported first quarter 2025 financial results and provided a corporate update. “We are thrilled with the continued rapid progress we are making to advance our co-lead programs, which we think could set a new standard in the treatment of psoriatic disease,” said Lawrence Klein, PhD, Chief Executive Officer of Oruka. “We’re excited to soon have both of our co-lead programs, ORKA-001 and ORKA-002, in the clinic and release our first clinical data on ORKA-001. As we ramp up preparations for our first psoriasis studies, we are energized by the reception from physicians who clearly see the potential to advance the treatment paradigm in this important disease.” First Quarter Business and Pipeline Updates ORKA-001: a novel half-life extended IL-23p19 monoclonal antibody Oruka’s Phase 1 trial of ORKA-001 is progressing, with dosing completed for all 24 subjects across three dose levels. The trial is a double-blind, placebo-controlled, single ascending dose study evaluating the safety, tolerability, and pharmacokinetics (PK) of ORKA-001. The Company expects to share interim data from this trial, including initial PK data, in 3Q 2025 (previously 2H 2025). Based on PK modeling, the Company expects that a human half-life of 50 days or more will support dosing every six months whereas a half-life of 75 days or more could support dosing once per year. In comparison, currently approved IL-23p19 inhibitors require maintenance dosing every two or three months. Oruka plans to initiate a Phase 2a proof-of-concept study of ORKA-001 in 2H 2025 that will enroll approximately 80 patients with moderate-to-severe plaque psoriasis. The planned study design is innovative, with a primary endpoint of PASI 100 at week 16 (versus PASI 90 for prior biologics studies) and maintenance arms evaluating a six-month dosing interval alongside a cohort of patients who are not re-dosed to test the potential for off-treatment remission in some patients. The Company expects to share efficacy and response duration data from this study in the 2H 2026. Psoriasis trials historically have low placebo rates and good reproducibility across phases of development, making this Phase 2a readout particularly impactful for derisking ORKA-001. ORKA-002: a novel half-life extended IL-17A/F monoclonal antibody Oruka plans to initiate a Phase 1 trial of ORKA-002 in 2Q 2025 (previously 3Q 2025). The trial is a double-blind, placebo-controlled, single ascending dose study evaluating the safety, tolerability, and PK of ORKA-002 in approximately 24 healthy volunteers. The Company expects to share interim data from this trial, including initial PK data, around year end 2025 (previously 1H 2026). At the American Academy of Dermatology Annual Meeting in March, the Company presented data from its preclinical studies of ORKA-002. The data showed that ORKA-002 has a half-life in non-human primates of over 30 days, more than three times longer than bimekizumab, which is expected to support a dose interval of two to three times per year. Also, ORKA-002 has similar potency to bimekizumab and binds to nearly identical epitopes on IL-17A and IL-17F with comparable affinity. Additional programs ORKA-021 (ORKA-002 → ORKA-001): Oruka continues to advance a sequential combination regimen of ORKA-002 and ORKA-001, which could deliver rapid and deep responses with an ideal maintenance profile. ORKA-021 could create another opportunity for the Company to define the best possible regimen for the treatment of psoriatic disease. ORKA-003: The Company continues to progress ORKA-003 through preclinical development. Based on competitive considerations, the Company is no longer planning to disclose additional details on ORKA-003 in 1H 2025. First Quarter 2025 Financial Results Cash Position: As of March 31, 2025, Oruka had available cash, cash equivalents, and marketable securities of $373.0 million. Net cash used in operating activities was $20.9 million for the first quarter of 2025. Research and Development (R&D) expenses: R&D expenses totaled $19.9 million and $5.2 million for the first quarter of 2025 and for the period from February 6, 2024 (inception) to March 31, 2024, respectively. The increase was driven by pre-clinical and clinical development and manufacturing expenses for the Company’s plaque psoriasis programs. These expenses include $3.0 million and $0.1 million of non-cash stock-based compensation for the first quarters of 2025 and 2024, respectively. General and Administrative (G&A) expenses: G&A expenses totaled $5.2 million and $1.7 million for the first quarter of 2025 and for the period from February 6, 2024 (inception) to March 31, 2024, respectively. The increases were primarily related to employee compensation-related expenses, including stock-based compensation, professional and consulting fees to support the growth in our operations, and costs associated with being a public company. These expenses include $1.9 million and less than $0.1 million of non-cash stock-based compensation for the first quarters of 2025 and 2024, respectively. Other income (expense), net: Other income, net for the first quarter of 2025 was $4.1 million, and other expense, net for the period from February 6, 2024 (inception) to March 31, 2024 was ($0.2) million. Other income for the first quarter of 2025 relates to interest earned on the Company’s investment in marketable securities. Other expenses, net for the first quarter of 2024 represent interest expense on convertible note. Net loss: Net loss totaled $21.0 million and $7.1 million for the first quarter of 2025 and for the period from February 6, 2024 (inception) to March 31, 2024, respectively, which includes non-cash stock-based compensation of $4.9 million and $0.1 million, for the first quarters of 2025 and 2024, respectively Shares Outstanding: Oruka has approximately 55.1 million shares of the Company’s common stock and common stock equivalents issued and outstanding, including shares of common stock underlying pre-funded warrants and non-voting convertible preferred stock. About Oruka Therapeutics Oruka Therapeutics is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice a year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit www.orukatx.com and follow Oruka on LinkedIn. Forward Looking Statements Certain statements in this press release, other than purely historical information, may constitute “forward-looking statements” within the meaning of the federal securities laws, including for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements relating to Oruka’s expectations, hopes, beliefs, intentions or strategies regarding the future of its pipeline and business including, without limitation, Oruka’s ability to achieve the expected benefits or opportunities with respect to ORKA-001 and ORKA-002, including timelines to clinical and data release milestones as well as trial initiation timelines, the details of its planned clinical studies, the potential half-life of ORKA-001 and ORKA-002 and the potential dosing intervals of ORKA-001 and ORKA-002, as well as Oruka’s anticipated cash runway. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting Oruka will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond Oruka's control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, those uncertainties and factors described under the heading “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in Oruka’s most recent filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K, Quarterly Report on Form 10-Q and its registration statement on Form S-1. Should one or more of these risks or uncertainties materialize, or should any of Oruka’s assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth therein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein and in Oruka’s SEC filings. Oruka does not undertake or accept any duty to make any updates or revisions to any forward-looking statements. Investor Contact: Alan Lada (650)-606-7911 [email protected]

