Lonigutamab

Finding a partner for lonigutamab would extend the series of deals involving the asset.\n Alumis is exploring strategic alternatives for its would-be rival to Amgen’s Tepezza, choosing to punt the program rather than pursue the phase 3 program envisaged before it acquired the asset.San Francisco-based Alumis added lonigutamab, an anti-IGF-1R antibody, to its pipeline when it merged with Acelyrin last year. At the time, Alumis CEO Martin Babler called the thyroid eye disease (TED) asset a potential best-in-class drug in a market served by Amgen. But rather than start the phase 3 trial Acelyrin was planning before the merger, Alumis paused to analyze the data before deciding on the next steps. One year after closing the merger, Alumis has decided against advancing the molecule internally. The decision could trigger a reassessment of the $51 million value assigned to lonigutamab at the time of acquisition, potentially forcing the company to write down that figure on its books.Alumis’ external R&D expenses for lonigutamab totaled $11.9 million last year. Spending slowed in the first quarter, dragging the figure down to $232,000. While Acelyrin shareholders owned 45% of the combined company after the merger, Alumis has focused on a TYK2 inhibitor, envudeucitinib, that it was developing before the deal, racking up $224 million in external R&D costs for the asset last year. Spending on lonigutamab marked a pullback from an asset that Acelyrin went all in on shortly before the merger. In 2024, Acelyrin stopped new internal investment in autoimmune prospect izokibep to focus on lonigutamab, reflecting a belief that the subcutaneous drug could provide more durable responses than intravenous Tepezza with fewer side effects, beating Amgen on convenience and the risk-benefit profile.Competition for the TED market has intensified since Acelyrin committed to lonigutamab. A phase 3 trial found that subcutaneous delivery of Tepezza using an on-body injector is as effective as the existing intravenous product, positioning Amgen to counter the potential for rivals to compete on convenience. Viridian Therapeutics has reported two phase 3 wins for its subcutaneous challenger without wowing investors. Finding a partner for lonigutamab would extend the series of deals involving the asset. ValenzaBio picked up rights to the asset outside of oncology from Pierre Fabre in 2021. Acelyrin bought ValenzaBio in 2023 and merged with Alumis in 2025. Had Alumis advanced lonigutamab, it could have paid up to $100.5 million in development and regulatory milestones and up to $390 million tied to commercial successes. 

– Late-breaking oral presentation of Phase 3 envudeucitinib data in moderate-to-severe plaque psoriasis (PsO) at the 2026 American Academy of Dermatology (AAD) Annual Meeting demonstrating early and robust improvements in skin clearance, quality of life, and symptoms – – Data showed robust PASI responses by Week 16, with significant continued improvements by Week 24 in PASI 90 (68.0%, 62.1%) and PASI 100 (41.0%, 39.5%) – – Data continue to underscore envudeucitinib’s potential as a leading oral therapy for PsO; plans to submit NDA in 4Q 2026 remain on track – – Potentially pivotal Phase 2b topline data for envudeucitinib in systemic lupus erythematosus (SLE) anticipated 3Q 2026 – SOUTH SAN FRANCISCO, Calif., May 14, 2026 (GLOBE NEWSWIRE) -- Alumis Inc. (Nasdaq: ALMS), a late-stage biopharmaceutical company developing next-generation targeted therapies for patients with immune-mediated diseases, today reported financial results for the quarter ended March 31, 2026, and highlighted recent achievements and upcoming milestones. "Alumis delivered a focused and productive first quarter, building on the Phase 3 clinical validation of envudeucitinib in moderate-to-severe plaque psoriasis and reinforcing the differentiated potential of maximal TYK2 inhibition," said Martin Babler, President and Chief Executive Officer of Alumis. "Late-breaking Phase 3 data at the 2026 American Academy of Dermatology Annual Meeting demonstrated leading skin-clearance outcomes and meaningful improvements in patient-reported quality-of-life measures, supporting a compelling emerging profile for physicians and patients, if approved, and further strengthening our confidence in envudeucitinib’s potential to reshape the psoriasis treatment landscape." Babler added, "We remain on track for our NDA submission in the fourth quarter of this year, as well as the potentially pivotal LUMUS Phase 2b topline readout in SLE in the third quarter. With continued progress across both indications, envudeucitinib is emerging as a potential ‘pipeline in a pill’, supporting expansion into additional immune-mediated diseases. We are evaluating further indications under a unified TYK2 franchise strategy and expect to share further updates later this year." First Quarter 2026 and Recent Highlights Envudeucitinib: a next-generation, highly selective oral tyrosine kinase 2 (TYK2) inhibitor, in patients with moderate-to-severe plaque psoriasis Late-breaking oral presentation of Phase 3 ONWARD1 and ONWARD2 envudeucitinib data at the 2026 American Academy of Dermatology (AAD) Annual Meeting (link to presentation) Envudeucitinib achieved robust PASI responses by Week 16, with significant continued improvements by Week 24, including PASI 90 responses of 68.0% and 62.1% and PASI 100 responses of 41.0% and 39.5% Quality-of-life improvements and itch relief emerged ahead of PASI 90 skin clearance, highlighting envudeucitinib’s early onset and broad clinical benefit Clear or almost clear scalp psoriasis, a high-impact, difficult-to-treat area, emerged as early as Week 4 in more than 30% of patients, and was observed in approximately three out of four patients by Week 241 Envudeucitinib demonstrated a favorable safety and tolerability profile consistent with the Phase 2 program Company management participated in a virtual key opinion leader (KOL) event following the AAD presentation featuring leading dermatology and psoriasis expert Dr. Andrew Blauvelt (link to the presentation and webcast replay: https://shorturl.at/A4Dh2) Narrative review published in peer-reviewed Dermatology and Therapy highlights envudeucitinib as a next-generation, oral, allosteric TYK2 inhibitor with strong molecular properties and favorable clinical efficacy and safety in psoriasis. The review synthesizes preclinical and clinical evidence demonstrating potent, sustained TYK2 inhibition and reinforces its potential across psoriasis and other immune-mediated diseases. (link to publication) Envudeucitinib achieved robust PASI responses by Week 16, with significant continued improvements by Week 24, including PASI 90 responses of 68.0% and 62.1% and PASI 100 responses of 41.0% and 39.5% Quality-of-life improvements and itch relief emerged ahead of PASI 90 skin clearance, highlighting envudeucitinib’s early onset and broad clinical benefit Clear or almost clear scalp psoriasis, a high-impact, difficult-to-treat area, emerged as early as Week 4 in more than 30% of patients, and was observed in approximately three out of four patients by Week 241 Envudeucitinib demonstrated a favorable safety and tolerability profile consistent with the Phase 2 program Lonigutamab Update Alumis has completed its strategic review of the lonigutamab program and decided to explore strategic alternatives for this asset. Anticipated 2026 Milestones Envudeucitinib in Moderate-to-Severe Plaque Psoriasis Long-term data - ONWARD3 topline data and Phase 2, two-year safety data (2H 2026) NDA submission (4Q 2026) Envudeucitinib in SLE Potentially pivotal Phase 2b SLE topline data (3Q 2026) Long-term data - ONWARD3 topline data and Phase 2, two-year safety data (2H 2026) NDA submission (4Q 2026) Potentially pivotal Phase 2b SLE topline data (3Q 2026) TYK2 Franchise Update on unified TYK2 franchise development strategy, including evaluation of additional indications (2Q 2026) Update on unified TYK2 franchise development strategy, including evaluation of additional indications (2Q 2026) Next clinical candidate (new target) Initiate Phase 1 trial (2H 2026) Initiate Phase 1 trial (2H 2026) First Quarter 2026 Financial Results As of March 31, 2026, Alumis had cash, cash equivalents and marketable securities of $569.5 million. Revenue included collaboration revenue of $1.7 million for the three months ended March 31, 2026, compared to license revenue of $17.4 million for the three months ended March 31, 2025, related to the collaboration and licensing agreement with Kaken Pharmaceutical Co., Ltd. Research and development expenses were $81.5 million for the three months ended March 31, 2026, compared to $96.6 million for the three months ended March 31, 2025. The decrease was primarily driven by lower contract research and clinical trial costs following completion of enrollment and reporting of positive topline results for the pivotal Phase 3 ONWARD1 and ONWARD2 clinical trials of envudeucitinib in patients with PsO in January 2026, partially offset by an increase in personnel-related expenses. General and administrative expenses were $18.6 million for the three months ended March 31, 2026, compared to $22.3 million for the three months ended March 31, 2025. The decrease was primarily attributable to transaction costs related to the merger with ACELYRIN, Inc. in the three months ended March 31, 2025, partially offset by an increase in personnel-related expenses. Net loss was $93.1 million for the three months ended March 31, 2026, compared to $99.0 million for the three months ended March 31, 2025. Financial Guidance Based on the Company’s current operating plan, Alumis continues to anticipate that its existing cash, cash equivalents and marketable securities as of March 31, 2026 are expected to fund operating expenses and capital expenditure requirements into the fourth quarter of 2027. About Alumis Alumis is a late-stage biopharmaceutical company developing next-generation targeted therapies with the potential to significantly improve patient health and outcomes across a range of immune-mediated diseases. Leveraging its proprietary data analytics platform and precision approach, Alumis is developing a pipeline of oral tyrosine kinase 2 inhibitors, consisting of envudeucitinib, formerly known as ESK-001, for the treatment of systemic immune-mediated disorders, such as moderate-to-severe plaque psoriasis and systemic lupus erythematosus, and A-005 with neuroinflammatory, neurodegenerative and peripheral immune-mediated disease indications under evaluation. For more information, visit www.alumis.com or follow us on LinkedIn or X. Forward-Looking Statements This press release contains forward-looking statements within the meaning of federal securities laws, including the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "anticipates," "believes," "plans," "seeks," "will" and variations of these words or similar expressions that are intended to identify forward-looking statements. All statements, other than statements of historical facts, including without limitation those regarding the timing of the initiation of clinical trials, including a Phase 1 trial for the Company's next clinical candidate, the timing of clinical data readouts in its ongoing clinical trials, including long-term and safety data, the timing of the Company’s planned NDA submission with the FDA for envudeucitinib in moderate-to-severe plaque psoriasis, the expected timing of the presentation of the Company’s TYK2 franchise strategy and the evaluation of additional indications, the potential for envudeucitinib to treat moderate-to-severe plaque psoriasis, the potential for envudeucitinib to reshape the psoriasis treatment landscape, systemic lupus erythematosus and other immune-mediated diseases, the Company's plans to explore strategic alternatives for lonigutamab, any expectations regarding the safety, efficacy or tolerability of its drug candidates and statements regarding Alumis’ future plans and prospects, including development of its clinical pipeline and the commencement of additional clinical trials; cash runway; Alumis’ participation at upcoming conferences, and any assumptions underlying any of the foregoing, are forward-looking statements. Forward-looking statements in this press release are based on Alumis’ current expectations, estimates and projections 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 and 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. Such risks and uncertainties include, without limitation, those related to Alumis’ ability to advance envudeucitinib or its other programs and to obtain regulatory approval of and ultimately commercialize Alumis’ clinical candidates, the timing, costs, 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) under the heading “Risk Factors” and elsewhere in such filings and reports, including any future reports Alumis may file with the SEC from time to time. Alumis explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law. Alumis Contact Information Teri DahlmanRed House Communicationsteri@redhousecomms.com ______________________1 Based on patients with baseline ss-PGA ≥3.