FTP-637

– Presented data at EADV supporting potential of ESK-001 as differentiated oral treatment in immune-mediated diseases through maximal TYK2 inhibition – – Continued to advance three clinical programs, including global Phase 3 ONWARD clinical trials for ESK-001 in moderate-to-severe plaque psoriasis, Phase 2b clinical trial for ESK-001 in systemic lupus erythematosus (SLE) and Phase 1 clinical study for A-005 being developed for neuroinflammatory and neurodegenerative diseases – SOUTH SAN FRANCISCO, Calif., Nov. 13, 2024 (GLOBE NEWSWIRE) -- Alumis Inc. (Nasdaq: ALMS), a clinical-stage biopharmaceutical company developing oral therapies using a precision approach to optimize clinical outcomes and significantly improve the lives of patients with immune-mediated diseases, today reported financial results for the third quarter ended September 30, 2024, and highlighted recent achievements and upcoming milestones. “I am pleased with the important progress we’ve made across our three clinical programs, as the team continues to show operational focus and execution, leveraging this momentum towards important upcoming data readouts,” said Martin Babler, President and Chief Executive Officer of Alumis. “ESK-001 and A-005 are designed to be differentiated in the TYK2 space by achieving maximal TYK2 inhibition at doses with a favorable safety profile. With the potential to combine high biologic-like efficacy with oral convenience, we are well positioned to deliver on the promise and impact that TYK2 inhibition can have for patients with immune-mediated diseases.” Babler continued, “We look forward to continuing to generate data with a goal of supporting best-in-class profiles for our programs, with A-005 Phase 1 data expected by year end and ESK-001 52-week Phase 2 OLE study data expected in the first quarter of 2025.” Third Quarter 2024 Highlights Presented data at 2024 European Academy of Dermatology & Venereology (EADV) Congress supporting ESK-001’s potential to offer a differentiated and best-in-class treatment profile for people with moderate-to-severe plaque psoriasis: Late-breaking 28-week data from the Open Label Extension (OLE) Phase 2 study show ESK-001 was generally well tolerated and most patients treated with the top dose of 40 mg twice daily achieved primary endpoint of PASI 75 (93% as observed (AO, n=71), 82.7% using modified non-responder imputation (mNRI, n=81)); Also, sPGA 0/1 responses of 76.1% (AO, n=71) and 67.9% (mNRI, n=81) were observed.Additional data presented show that the 40 mg twice daily dose, which achieves maximal target inhibition according to blood and skin biopsy biomarkers, leads to the highest response rates. Importantly, positive efficacy and safety outcomes are associated with significant improvements in patients’ reported quality of life outcomes. These findings support use of the 40 mg twice daily dose in the ongoing Phase 3 clinical program. Continued to advance three clinical programs in immune-mediated diseases: The Phase 3 ONWARD program for ESK-001 in moderate-to-severe plaque psoriasis consists of two parallel 24-week global Phase 3 clinical trials (ONWARD1 and ONWARD2) designed to evaluate the efficacy and safety of ESK-001 in adult patients with moderate-to-severe plaque psoriasis and also includes a long-term extension (LTE) trial, ONWARD3, designed to evaluate durability and maintenance of response and long-term safety. Topline results are anticipated in the first half of 2026.The Phase 2b LUMUS program for ESK-001 in SLE is designed to evaluate the efficacy, safety and pharmacokinetics of multiple doses of ESK-001 in adult patients with moderately to severely active, autoantibody-positive SLE. Topline results are anticipated in 2026.The Phase 1 clinical study of A-005, a potential first-in-class, central nervous system (CNS) penetrant TYK2 inhibitor being developed for the treatment of neuroinflammatory and neurodegenerative diseases, is designed to assess the safety, tolerability, and pharmacokinetics of single and multiple-ascending orally administered doses of A-005 in healthy participants, including confirmation of CNS penetration in humans. Data readout is anticipated by year-end 2024. Anticipated Milestones 2024 A-005: Phase 1 clinical study data in healthy participants (by year-end) 2025 A-005: Initiation of Phase 2 clinical trial in multiple sclerosis (MS)ESK-001: Phase 2 OLE 52-week data update in psoriasisThird pipeline program: Investigational New Drug Application filing for third clinical candidate 2026 ESK-001: Psoriasis Phase 3 topline data (1H 2026)ESK-001: SLE Phase 2b topline dataA-005: MS Phase 2 topline data Third Quarter 2024 Financial Results As of September 30, 2024, Alumis had cash and cash equivalents and marketable securities of $361.9 million, which is expected to fund operations into 2026.Research and development expenses were $87.8 million for the quarter ended September 30, 2024, compared to $37.8 million for the same period in 2023. The increase was driven by a clinical milestone payment of $23.0 million related to a prior acquisition of FronThera, an increase in contract manufacturing and clinical trial costs for the ESK-001 and A-005 programs, as well as increased headcount in research and development teams to support development efforts.General and administrative expenses were $10.6 million for the quarter ended September 30, 2024, compared to $6.0 million for the same period in 2023. The increase was primarily attributable to personnel-related expenses and professional consulting services to support the Company’s growth and business development.Net loss was $93.1 million for the quarter ended September 30, 2024, compared to $43.4 million for the same period in 2023. Upcoming Events Alumis will be presenting two posters at ACR Convergence 2024, the annual meeting of the American College of Rheumatology (ACR) taking place November 14-19 in Washington, D.C. About Alumis Alumis is a clinical-stage biopharmaceutical company developing oral therapies using a precision approach to optimize clinical outcomes and significantly improve the lives of patients with immune-mediated diseases. Leveraging its proprietary precision data analytics platform, Alumis is building a pipeline of molecules with the potential to address a broad range of immune-mediated diseases as monotherapy or combination therapies. Alumis’ most advanced product candidate, ESK-001, is an oral, highly selective, small molecule, allosteric inhibitor of tyrosine kinase 2 that is currently being evaluated for the treatment of patients with moderate-to-severe plaque psoriasis and systemic lupus erythematosus. Alumis is also developing A-005, a CNS-penetrant, allosteric TYK2 inhibitor for the treatment of neuroinflammatory and neurodegenerative diseases. Beyond TYK2, Alumis’ proprietary precision data analytics platform and drug discovery expertise have led to the identification of additional preclinical programs that exemplify its precision approach. Incubated by Foresite Labs and led by a team of industry veterans experienced in small-molecule compound drug development for immune-mediated diseases, Alumis is pioneering a precision approach to drug development to potentially produce the next generation of treatment to address immune dysfunction. For more information, visit www.alumis.com. Forward-Looking StatementsThis press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will" and variations of these words or similar expressions that are intended to identify forward-looking statements. Any such statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements include, without limitation, statements regarding Alumis’ future plans and prospects, its anticipated milestones (including, without limitation, the expected timing of clinical trial results), its participation at upcoming conferences, its ability to accomplish its mission to bring new, effective treatment options to patients living with immune-mediated diseases, the success, cost and timing of its product candidate development activities and current and future clinical trials and studies, including study design, any expectations regarding the safety, efficacy or tolerability of ESK-001, including based on the clinical update from Alumis’ Phase 2 STRIDE clinical trial and ongoing OLE study, the ability of ESK-001 to treat moderate-to-severe plaque psoriasis or SLE, any expectations regarding the safety, efficacy or tolerability of A-005, and the ability of A-005 to treat MS and other neuroinflammatory and neurodegenerative diseases, and expectations regarding the sufficiency and runway of capital resources. Any forward-looking statements in this press release are based on Alumis’ current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Readers are cautioned that actual results, levels of activity, safety, efficacy, performance or events and circumstances could differ materially from those expressed or implied in Alumis’ forward-looking statements due to a variety of risks and uncertainties, which include, without limitation, risks and uncertainties related to Alumis’ ability to advance ESK-001 and its other clinical candidates and to obtain regulatory approval of and ultimately commercialize Alumis’ clinical candidates, the timing and results of preclinical and clinical trials, Alumis’ ability to fund development activities and achieve development goals, Alumis’ ability to protect its intellectual property and other risks and uncertainties described in Alumis’ filings with the Securities and Exchange Commission (SEC), including those described from time to time under the caption “Risk Factors” and elsewhere in Alumis’ current and future reports filed with the SEC, including its Quarterly Report on Form 10-Q for the quarter ended June 30, 2024. Alumis explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law. ALUMIS INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS ANDCOMPREHENSIVE LOSS (Unaudited) Three Months Ended September 30, Nine Months Ended September 30, (in thousands) 2024 2023 2024 2023 Operating expenses: Research and development expenses $87,824 $37,788 $178,350 $103,071 General and administrative expenses 10,575 5,971 23,782 14,971 Total operating expenses 98,399 43,759 202,132 118,042 Loss from operations (98,399) (43,759) (202,132) (118,042)Other income (expense): Interest income 5,322 951 8,153 2,509 Change in fair value of derivative liability — (551) (5,406) (119) Other income (expense), net (40) (18) (89) (41) Total other income (expense), net 5,282 382 2,658 2,349 Net loss $(93,117) $(43,377) $(199,474) $(115,693) Other comprehensive income (loss) Unrealized gain (loss) on marketable securities, net 140 (3) 137 127 Net loss and other comprehensive loss $(92,977) $(43,380) $(199,337) $(115,566) ALUMIS INC.CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) September 30, December 31, (in thousands) 2024 2023 Assets Current assets: Cash and cash equivalents $213,417 $45,996 Restricted cash — 113 Marketable securities 148,453 2,956 Research and development prepaid expenses 12,241 2,661 Other prepaid expenses and current assets 3,236 1,631 Total current assets 377,347 53,357 Restricted cash, non-current 1,024 1,024 Property and equipment, net 21,429 22,441 Operating lease right-of-use assets, net 12,752 12,783 Other long-term assets 7 7 Total assets $412,559 $89,612 Liabilities, Redeemable Preferred Stock and Stockholders' Equity (Deficit) Current liabilities: Accounts payable $6,444 $1,118 Research and development accrued expenses 18,140 10,946 Other accrued expenses and current liabilities 7,464 7,087 Operating lease liabilities, current 1,467 1,720 Total current liabilities 33,515 20,871 Operating lease liabilities, non-current 29,631 30,860 Share repurchase liability 1,024 1,771 Total liabilities 64,170 53,502 Redeemable convertible preferred stock — 375,370 Stockholders' equity (deficit) Preferred stock — — Common stock 5 1 Additional paid-in-capital 912,037 25,055 Accumulated other comprehensive income 139 2 Accumulated deficit (563,792) (364,318)Total stockholders' equity (deficit) 348,389 (339,260) Total liabilities, redeemable convertible preferred stock and stockholders' equity (deficit) $412,559 $89,612

JAK inhibitors are a class of medications that work by blocking Janus kinases (JAKs), enzymes that are involved in the signaling pathways of various cytokines and growth factors. JAK inhibitors offer a more targeted approach to treating immune-mediated diseases compared to traditional therapies like corticosteroids or conventional immunosuppressants; this specificity reduces side effects and increases efficacy and is a major driver for the demand for JAK inhibitors. LAS VEGAS, Oct. 22, 2024 /PRNewswire/ -- DelveInsight's ' JAK Inhibitors Pipeline Insight 2024 ' report provides comprehensive global coverage of pipeline JAK inhibitors in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the JAK inhibitors pipeline domain. Key Takeaways from the JAK Inhibitors Pipeline Report DelveInsight's JAK inhibitors pipeline report depicts a robust space with 50+ active players working to develop 55+ pipeline JAK inhibitors. Key JAK inhibitors companies such as Incyte Corporation, Celon Pharma, Aclaris Therapeutics, Sareum, AstraZeneca, Incyte Corporation, Ajax Therapeutics, Pfizer, GSK, Dizal Pharmaceutical, Confluence Life Sciences, Celon Pharma, Incyte Corporation, Arcutis Biotherapeutics/Reistone Biopharma, Esker Therapeutics, Bristol-Myers Squibb, Chia Tai Tianqing Pharmaceutical and others are evaluating new JAK Inhibitors drugs to improve the treatment landscape. Promising pipeline JAK inhibitors such as Povorcitinib, CPL409116, ATI-2138, SDC 1802, AZD 4604, INCB-160058, Research programme: JAK2 inhibitors, Ritlecitinib, Momelotinib, DZD4205, ATI 2138, CPL 409116, Itacitinib, Ivarmacitinib, ESK 001, Repotrectinib, Rovadicitinib, and others are under different phases of JAK inhibitors clinical trials. In October 2024, Pelabresib in combination with ruxolitinib showed benefit in treating patients with JAK Inhibitor-Naïve Myelofibrosis significantly reduced splenomegaly, and improved anemia that has not been previously treated with Janus kinase inhibitors (JAKis). In September 2024, Eli Lilly and Company and EVA Pharma announced that the companies have agreed to expand access to baricitinib to an estimated 20,000 people in 49 low- to middle-income countries in Africa by 2030. In May 2024, Ajax Therapeutics, Inc., announced that it had received clearance for its Investigational New Drug application from the U.S. Food and Drug Administration (FDA) to initiate a Phase I clinical study of AJ1–11095, a first-in-class Type II JAK2 inhibitor, for the treatment of patients with myelofibrosis. In February 2024, Novartis announced that it intends to acquire MorphoSys. The acquisition, which was unanimously approved by the boards of both Novartis and MorphoSys, is expected to close in the first half of 2024, subject to customary closing conditions. In January 2024, NS Pharma received orphan drug designation (ODD) from the European Commission (EC) for NS-229, which is being developed to treat eosinophilic granulomatosis with polyangiitis (EGPA), a rare autoimmune disease. In December 2023, Sun Pharmaceuticals Inc. announced that it has entered a licensing agreement with Aclaris Therapeutics Inc., the company announced in a regulatory filing. Under the agreement, Aclaris granted Sun Pharma exclusive rights under certain patents for the use of deuruxolitinib, Sun Pharma's JAK inhibitor, or other isotopic forms of ruxolitinib, to treat alopecia areata (AA) or androgenetic alopecia (AGA). Request a sample and discover the recent advances in JAK inhibitors drugs @ JAK Inhibitors Pipeline Report The JAK inhibitors pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage JAK inhibitors drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the JAK inhibitors clinical trial landscape. JAK Inhibitors Overview Janus kinase (JAK) inhibitors are a class of medications designed to interfere with the activity of the Janus kinase family of enzymes, which play a crucial role in the signaling pathways of immune responses. These enzymes are key mediators in transmitting signals from cytokines and growth factors, which regulate blood cell production and immune system function. By blocking these signals, JAK inhibitors help to control the overactive immune response seen in several inflammatory and autoimmune diseases. They have shown significant efficacy in treating conditions like rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis, among others. The most common JAK inhibitors include tofacitinib, baricitinib, and upadacitinib, which are administered orally. Beyond their role in autoimmune diseases, JAK inhibitors are also being explored for use in treating certain cancers and myeloproliferative disorders, where abnormal JAK signaling contributes to uncontrolled cell growth. In diseases like myelofibrosis and polycythemia vera, JAK inhibitors can help reduce symptoms and improve quality of life. However, there are potential side effects associated with their use, including increased susceptibility to infections, blood clots, and cardiovascular risks, given their impact on the immune system. As research continues, the therapeutic potential of JAK inhibitors is expanding, offering new hope for patients with difficult-to-treat conditions. Find out more about JAK inhibitors drugs @ JAK Inhibitors Analysis A snapshot of the Pipeline JAK Inhibitors Drugs mentioned in the report: Learn more about the emerging JAK inhibitors @ JAK Inhibitors Clinical Trials JAK Inhibitors Therapeutics Assessment The JAK inhibitors pipeline report proffers an integral view of the emerging JAK inhibitors segmented by stage, product type, molecule type, and route of administration. Scope of the JAK Inhibitors Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous, Parenteral, Topical Therapeutics Assessment By Molecule Type: Recombinant fusion proteins, Small molecule, Monoclonal antibody, Peptide, Polymer, Gene therapy Key JAK Inhibitors Companies: Incyte Corporation, Celon Pharma, Aclaris Therapeutics, Sareum, AstraZeneca, Incyte Corporation, Ajax Therapeutics, Pfizer, GSK, Dizal Pharmaceutical, Confluence Life Sciences, Celon Pharma, Incyte Corporation, Arcutis Biotherapeutics/Reistone Biopharma, Esker Therapeutics, Bristol-Myers Squibb, Chia Tai Tianqing Pharmaceutical, and others. Key JAK Inhibitors Pipeline Therapies: Povorcitinib, CPL409116, ATI-2138, SDC 1802, AZD 4604, INCB-160058, Research programme: JAK2 inhibitors, Ritlecitinib, Momelotinib, DZD4205, ATI 2138, CPL 409116, Itacitinib, Ivarmacitinib, ESK 001, Repotrectinib, Rovadicitinib, and others. Dive deep into rich insights for new JAK inhibitors, visit @ JAK Inhibitors Drugs Table of Contents For further information on the JAK inhibitors pipeline therapeutics, reach out @ JAK Inhibitors Therapeutics Related Reports JAK Inhibitors Market JAK Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast – 2034 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key JAK inhibitors companies, including Eli Lilly and Company, Suzhou Zelgen Biopharmaceuticals Co., Ltd, Incyte Corporation, Kartos Therapeutics, Inc., Dompé Farmaceutici S.p.A, Sanofi, Kiniksa Pharmaceuticals, Ltd., Celgene, Abivax S.A., Telios Pharma, Inc., AstraZeneca, Karyopharm Therapeutics Inc, TWi Biotechnology, Inc., Geron Corporation, Ajax Therapeutics, Inc., among others. JAK Inhibitors Competitive Landscape JAK Inhibitors Competitive Landscape – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key JAK inhibitors companies, including Pfizer, Sierra Oncology, Theravance Biopharma, Dizal Pharmaceutical, Aclaris Therapeutics, Celon Pharma, Incyte Corporation, AbbVie, Galapagos, among others. KRAS Inhibitors Market KRAS Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key KRAS inhibitors companies, including Novartis, Roche, Genentech, Verastem Oncology, Revolution Medicines, Cardiff Oncology, Immuneering Corporation, Jacobio Pharmaceuticals, BridgeBio Pharma, Mirati Therapeutics, Deciphera Pharmaceuticals, Elicio Therapeutics, InventisBio, Gritstone Bio, D3 Bio , among others. PD/L-1 Inhibitors Market PD/L-1 Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast – 2034 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key PD/L-1 inhibitors companies, including Merck, Laekna Therapeutics, Genentech, Tracon Pharmaceuticals Inc., Celgene, MedImmune, Hangzhou Sumgen Biotech, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED