Successful go-public transaction and over $475 million raised this year provides cash runway through multiple clinical inflection points ORKA-001 non-human primate (NHP) pharmacokinetic and in vitro potency data, presented at EADV in September, further support and derisk the program Strong execution allowed for acceleration of clinical timelines for both ORKA-001 and ORKA-002, as previously announced MENLO PARK, Calif., Nov. 13, 2024 (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, today reported third quarter 2024 financial results and provided a corporate update. “We had a highly eventful third quarter which included going public, closing on over $475 million in proceeds across two transactions and continuing to progress our very promising co-lead programs,” said Lawrence Klein, PhD, Chief Executive Officer of Oruka. “We are excited to soon transition to a clinical stage company and show the potential of our programs to raise the bar on what is possible in psoriatic disease.” Third Quarter Business and Pipeline Updates Corporate Oruka consummated its go-public transaction and began trading on the Nasdaq under the ticker ORKA.The Company raised over $475 million, including a $275 million private placement previously announced in April that closed concurrently with the merger and an additional $200 million private placement shortly thereafter from a group of new and existing investors. ORKA-001: a novel half-life extended IL-23p19 monoclonal antibody Oruka plans to initiate a Phase 1 trial of ORKA-001 in the first quarter of 2025, which was accelerated from the first half of 2025. The Company expects to share interim data from the first-in-human trial in healthy volunteers, including initial pharmacokinetic data, in the second half of 2025 and initial efficacy data in psoriasis patients in the second half of 2026.Data presented at the European Academy of Dermatology and Venereology (EADV) Congress showed that ORKA-001 has a half-life in NHP of more than 30 days, over three times longer than risankizumab and one of the longest NHP half-lives observed for an extended half-life antibody. In addition, the data showed that ORKA-001 binds to a similar epitope as risankizumab and displays similar binding affinity and potency across a variety of in vitro assays.These findings support the potential for ORKA-001 to achieve extended dosing intervals of once every six months or even once a year while maintaining high antibody exposures and further derisk its development path. ORKA-002: a novel half-life extended IL-17A/F monoclonal antibody Oruka plans to initiate a Phase 1 trial of ORKA-002 in the third quarter of 2025, which was accelerated from the second half of 2025. The Company expects to share interim data from the first-in-human trial in healthy volunteers, including initial pharmacokinetic data, in the first half of 2026.A precursor antibody to ORKA-002 showed a half-life in NHP of approximately 20 days, double that seen with bimekizumab, supporting the potential to achieve significantly longer dosing intervals than currently marketed agents targeting IL-17. This extended half-life could enable a dosing interval of once every four to six months for ORKA-002. Third Quarter 2024 Financial Results Cash Position: As of September 30, 2024, Oruka had available cash and cash equivalents of $410.9 million. Net cash used in operating activities was $27.8 million for the third quarter of 2024. The Company expects this cash to provide runway through 2027. Research and Development (R&D) expenses: R&D expenses totaled $25.7 million for the third quarter of 2024. This expense includes $7.8 million of non-cash stock-based compensation. During the third quarter of 2024, the Company incurred $11.8 million and $4.1 million on the development of ORKA-001 and ORKA-002, respectively. General and Administrative (G&A) expenses: G&A expenses totaled $3.8 million for the third quarter of 2024. This expense includes $2.4 million of personnel-related costs, including $1.2 million of non-cash stock-based compensation related to equity awards to employees and service providers, and $1.3 million for professional, consulting, and other costs to operate a public company and support R&D activities. Other income (expense): Other income, net for the third quarter of 2024 was $0.8 million. Interest earned on the Company’s investment in money market funds was $1.3 million for the third quarter of 2024, partly offset by interest expense of $0.5 million on convertible notes before their conversion to common stock. Net loss: Net loss totaled $28.6 million for the third quarter of 2024, which includes non-cash stock-based compensation of $9.0 million. 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 Series A and Series B 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, the potency, binding affinity, efficacy and antibody exposures of ORKA-001, including vis-à-vis risankizumab, the potential half-life of ORKA-001 and ORKA-002 and their potential dosing intervals, and Oruka’s cash runway. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. 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, including its 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. 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 alan.lada@orukatx.com ORUKA THERAPEUTICS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) (unaudited) September 30, February 6, Assets2024 2024 Current assets: Cash and cash equivalents$410,875 $— Subscription receivables — 1 Prepaid expenses and other current assets 2,074 Total current assets 412,949 1 Property and equipment, net 160 — Operating lease right-of-use assets 938 — Other non-current assets 43 — Total assets$414,090 $1 Liabilities, Convertible Preferred Stock and Stockholders’ Equity Current liabilities: Accounts payable$2,145 $— Accrued expenses and other current liabilities 1,710 — Operating lease liability, current 146 — Related party common stock warrant liability 7,681 — Related party accounts payable and current liabilities 6,357 — Total current liabilities 18,039 — Operating lease liability, non-current 842 — Total liabilities 18,881 — Commitments and contingencies Preferred stock 52,841 — Stockholders’ equity: Preferred stock 2,931 — Common stock 35 — Additional paid-in capital 397,345 1 Accumulated deficit (57,943) — Total stockholders’ equity 342,368 1 Total liabilities, convertible preferred stock and stockholders’ equity$414,090 $1 ORUKA THERAPEUTICS, INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS(in thousands, except share and per share data)(unaudited) Three Months EndedSeptember 30, 2024 Period fromFebruary 6, 2024(Inception) toSeptember 30, 2024Operating expenses Research and development(1)$25,691 $49,557 General and administrative(1) 3,758 8,248 Total operating expenses 29,449 57,805 Loss from operations (29,449) (57,805)Other income (expense) Interest income 1,330 1,330 Interest expense (504) (1,468)Total other income (expense), net 826 (138)Net loss and comprehensive loss$(28,623) $(57,943)Net loss per share attributable to common stockholders, basic and diluted$1.46 $6.08 Net loss per share attributable to Series A non-voting convertible preferred Stockholders, basic and diluted$1,461.10 $6,077.25 Net loss per share attributable to Series B non-voting convertible preferred Stockholders, basic and diluted$121.76 $506.44 Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted 15,013,655 7,765,381 Weighted-average shares used in computing net loss per share attributable to Series A non-voting convertible preferred stockholders, basic and diluted 477 184 Weighted-average shares used in computing net loss per share attributable to Series B non-voting convertible preferred stockholders, basic and diluted 49,191 19,015 (1) Amounts include non-cash stock based compensation expense as follows (in thousands): Three Months EndedSeptember 30, 2024 Period fromFebruary 6, 2024(Inception) toSeptember 30, 2024 Research and development$7,772 $8,310 General and administrative 1,229 1,459 Total$9,001 $9,769

财报临床1期临床结果

2024-09-25

·PipelineReview

Oruka Therapeutics Announces Preclinical Data for ORKA-001 at the European Academy of Dermatology and Venereology Congress

Half-life in non-human primates (NHP) of 30.3 days after subcutaneous (SQ) administration and 33.8 days after intravenous (IV) administration Equivalent potency to risankizumab with similar binding affinity and epitope demonstrated in several preclinical assays MENLO PARK, CA, USA I September 25, 2024 I 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 new preclinical data on ORKA-001, a novel extended half-life monoclonal antibody targeting IL-23p19, from its presentation at the European Academy of Dermatology and Venereology Congress (EADV). “This new data gives us additional confidence that ORKA-001 can achieve our base-case expectation of dosing once every six months and further reason to believe that we could reach once-yearly dosing with the potential for higher efficacy,” said Lawrence Klein, Oruka’s Chief Executive Officer. “Our goal is to offer people with psoriasis the most possible freedom from their condition, and we think ORKA-001 is showing tremendous potential to achieve that.” About ORKA-001 ORKA-001 is a novel, subcutaneously (SQ) 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 a year and is designed to achieve higher exposures than currently marketed IL-23p19 antibodies, which could lead to higher rates of disease clearance. Data from studies in non-human primates and other preclinical assays show that ORKA-001 binds to a similar epitope with similar affinity as risankizumab and has a significantly extended half-life over three times longer than risankizumab. 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. SOURCE: Oruka Therapeutics

免疫疗法

2024-09-12

·GlobeNewswire-Health Care

Oruka Therapeutics Announces Accelerated Clinical Timelines and Upcoming Presentation at EADV Supporting ORKA-001’s Profile as a Potentially Best-in-Class Half-Life Extended Antibody Targeting IL-23p19

ORKA-001, a novel half-life extended IL-23p19 monoclonal antibody (mAb), first-in-human dosing now expected first quarter 2025 ORKA-002, a novel half-life extended IL-17A/F mAb, first-in-human dosing now expected third quarter 2025 New preclinical data on ORKA-001 to be presented at EADV in September showing robust preclinical activity including a half-life in NHPs of over 30 days MENLO PARK, Calif., Sept. 12, 2024 (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 updated pipeline progress and timelines, as well as an upcoming scientific presentation at the European Academy of Dermatology and Venereology Congress (EADV). First-in-human dosing of ORKA-001 in healthy volunteers is now expected to start during the first quarter of 2025. ORKA-001 is a novel, subcutaneously (SQ) administered, half-life extended mAb 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 a year and is designed to achieve higher exposures than currently marketed IL-23p19 antibodies, which could lead to higher rates of disease clearance. The company expects to share interim data from the first-in-human trial in healthy volunteers in the second half of 2025 and initial efficacy data in psoriasis patients in the second half of 2026.First-in-human dosing of ORKA-002 in healthy volunteers is now expected to start during the third quarter 2025. ORKA-002 is a novel, SQ administered, half-life extended mAb targeting IL-17A/F. Dual inhibition of IL-17A and F has resulted in high PASI 100 rates in PsO and is ideally suited to patients with concurrent psoriatic arthritis (PsA) or recalcitrant skin disease. IL-17A/F inhibition has also shown promising efficacy in other diseases such as hidradenitis suppurativa (HS) and axial spondyloarthritis (axSpA). ORKA-002 is designed to provide patients with a treatment option with substantially less frequent dosing, while offering similar disease clearance to established agents. The company expects to share interim data from the first-in-human trial in healthy volunteers in the first half of 2026.Oruka will present preclinical data on ORKA-001 for the first time at EADV. The presentation will include in vitro potency compared to benchmark antibodies and pharmacokinetics showing that ORKA-001 has a half-life of over 30 days in non-human primates (NHPs). This NHP half-life is toward the higher end of those observed for half-life extended antibodies and increases the likelihood that an improved human half-life will be observed, potentially enabling extended dose intervals with higher antibody exposures than established regimens. “The Oruka team has worked incredibly hard to progress our programs towards the clinic, with our first drug candidate now expected to be in humans approximately a year from the Company’s inception,” said Lawrence Klein, Oruka’s Chief Executive Officer. “The excellent pharmacokinetic profile in NHPs supports our conviction that ORKA-001 could provide patients greater freedom from disease than currently available agents.” Details of the presentation at EADV, September 25-28, 2024, in Amsterdam, Netherlands are as follows: Characterization of ORKA-001, a Novel Extended Half-life Monoclonal Antibody Targeting IL-23 for the Treatment of PsoriasisAbstract #4711, E-Poster #P3283 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 the expected timelines for first in human dosing and interim and initial efficacy data from such trials, the ultimate profile of products from each program and the potential of ORKA-001 and ORKA-002 to become best-in-class drugs. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. 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 (including its S-4 Registration Statement). 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. 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 alan.lada@orukatx.com

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