Sonelokimab

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

MoonLake Immunotherapeutics to host a Capital Markets Updateon Wednesday, September 11 ZUG, Switzerland, September 9, 2024 – MoonLake Immunotherapeutics AG (“MoonLake”; Nasdaq: MLTX), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, will host a Capital Markets Update for investors and analysts live from New York on Wednesday, September 11 from 2024, from 9:00 – 10:30 EST/06:00 – 08:30 PST/14:00 – 16:30 CETThe event will provide business updates from MoonLake’s CEO Jorge Santos da Silva, CSO Kristian Reich and CFO Matthias Bodenstedt and include details on the Phase 3 programs for our investigational Nanobody® sonelokimab (SLK) in hidradenitis suppurativa (HS) and psoriatic arthritis (PsA). In addition, MoonLake will provide pipeline updates and details on additional catalysts for the 2024-2026 period, including for trials in new indications such as the Phase 2 trials of SLK in palmo-plantar pustulosis (PPP). The Company will share views on the market opportunities featuring insights from recent data analyses, competitor performance and strategic imperatives for the Company. A presentation on our financials will also be included. A Q&A session involving all speakers will follow the presentations. Please register for the webcast online here:https://edge.media-server.com/mmc/p/ncvrwcf8 Further details will be available on the Events & Presentations section of the Company’s website. -Ends- About MoonLake Immunotherapeutics MoonLake Immunotherapeutics is a clinical-stage biopharmaceutical company unlocking the potential of sonelokimab, a novel investigational Nanobody® for the treatment of inflammatory disease, to revolutionize outcomes for patients. Sonelokimab inhibits IL-17A and IL-17F by inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers that drive inflammation. The company’s focus is on inflammatory diseases with a major unmet need, including hidradenitis suppurativa and psoriatic arthritis – conditions affecting millions of people worldwide with a large need for improved treatment options. MoonLake was founded in 2021 and is headquartered in Zug, Switzerland. Further information is available at www.moonlaketx.com. About Sonelokimab Sonelokimab (M1095) is an investigational ~40 kDa humanized Nanobody® consisting of three VHH domains covalently linked by flexible glycine-serine spacers. With two domains, sonelokimab selectively binds with high affinity to IL-17A and IL-17F, thereby inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers. A third central domain binds to human albumin, facilitating further enrichment of sonelokimab at sites of inflammatory edema. Sonelokimab is being assessed in two lead indications, hidradenitis suppurativa (HS) and psoriatic arthritis (PSA), and the Company is pursuing other indications in dermatology and rheumatology. For HS, sonelokimab is being assessed in two Phase 3 trials, VELA-1 and VELA-2 following the successful outcome of MoonLake’s end-of-Phase 2 interactions with the FDA and as well as positive feedback from its interactions with the EMA announced in February 2024. In October 2023, the full dataset from the Phase 2 MIRA trial at 24 weeks (NCT05322473) showed that maintenance treatment with sonelokimab led to further improvements in Hidradenitis Suppurativa ClinicalResponse (HiSCR)75 which is a higher measure of clinical response versus the HiSCR50 measure used in other clinical trials, setting a landmark milestone and other clinically relevant outcomes. Prior to this, in June 2023, topline results of the MIRA trial at 12 weeks showed that the trial met its primary endpoint, HiSCR75. For PsA, Phase 3 initiation is anticipated in Q4 2024 following the announcement in March 2024 of the full dataset from the global Phase 2 ARGO trial evaluating the efficacy and safety of the Nanobody® sonelokimab over 24 weeks in patients with active PsA. Significant improvements were observed across all key outcomes, including approximately 60% of patients treated with sonelokimab achieving an ACR50 response at week 24. This followed the positive top-line results in November 2023, where the trial met its primary endpoint with a statistically significant greater proportion of patients treated with either sonelokimab 60mg or 120mg (with induction) achieving an American College of Rheumatology (ACR) 50 response compared to those on placebo at week 12. All key secondary endpoints in the trial were met for the 60mg and 120mg doses with induction. A Phase 2 trial is expected to be initiated in palmo-plantar pustulosis (PPP), a debilitating disease affecting a significant number of patients. In addition, a Phase 3 trial is expected to initiate in adolescent HS, a disease that typically begins at this early stage of a patient’s life, and also the period in which irreversible damage and inflammatory remission is most critical. Sonelokimab will also be assessed for seronegative spondyloarthritis with a Phase 2 trial in radiographic and non-radiographic axial spondyloarthritis (axSpA) expected to start in 2024. The trials will feature an innovative design complementing traditional clinical outcomes with modern imaging techniques. Sonelokimab has also been assessed in a randomized, placebo-controlled Phase 2b trial (NCT03384745) in 313 patients with moderate-to-severe plaque-type psoriasis. High threshold clinical responses (Investigator’s Global Assessment Score 0 or 1, and Psoriasis Area and Severity Index 90/100) were observed in patients with moderate-to-severe plaque-type psoriasis. Sonelokimab was generally well tolerated, with a safety profile similar to the active control, secukinumab (Papp KA, et al. Lancet. 2021; 397:1564-1575). In an earlier Phase 1 trial in patients with moderate-to-severe plaque-type psoriasis, sonelokimab has been shown to decrease (to normal skin levels) the cutaneous gene expression of pro-inflammatory cytokines and chemokines (Svecova D. J Am Acad Dermatol. 2019;81:196–203). About Nanobodies® Nanobodies® represent a new generation of antibody-derived targeted therapies. They consist of one or more domains based on the small antigen-binding variable regions of heavy-chain-only antibodies (VHH). Nanobodies® have a number of potential advantages over traditional antibodies, including their small size, enhanced tissue penetration, resistance to temperature changes, ease of manufacturing, and their ability to be designed into multivalent therapeutic molecules with bespoke target combinations. The terms Nanobody® and Nanobodies® are trademarks of Ablynx, a Sanofi company. CONTACT MoonLake Immunotherapeutics InvestorsCarla Bretes, Director IR & BDMatthias Bodenstedt, CFOir@moonlaketx.com MoonLake Immunotherapeutics MediaPatricia Sousa, Director Corporate Affairsmedia@moonlaketx.com ICR Consilium Mary-Jane Elliott, Ashley Tapp, Namrata TaakTel: +44 (0) 20 3709 5700MoonLake@consilium-comms.com