Full Press Release Details
– Positive Phase 3 topline results demonstrating envudeucitinib’s leading skin clearance, meaningful symptom improvement and a favorable safety profile in patients with moderate-to-severe plaque psoriasis (PsO) –
– Plan to submit NDA for envudeucitinib in PsO in 2H 2026 –
– Potentially pivotal Phase 2b clinical topline data for envudeucitinib insystemic lupus erythematosus (SLE) anticipated 3Q 2026 –
– Presentation of additional Phase 3 ONWARD1 and ONWARD2 data at AAD2026 –
– Completed an upsized public offering raising $345.1 million in gross proceeds in Jan 2026 –
SOUTH SAN FRANCISCO, Calif., March 19, 2026(GLOBE NEWSWIRE)-- Alumis Inc. (Nasdaq: ALMS), a late-stage biopharma company developing next-generation targeted therapies for patients with immune-mediated diseases, today reported financial results for the year ended December 31, 2025, and highlighted recent achievements and upcoming milestones.
“Alumis concluded a pivotal year marked by strong execution and the Phase 3 clinical validation of envudeucitinib in moderate-to-severe plaque psoriasis, underscoring the promise of TYK2 inhibition and envudeucitinib’s highly differentiated clinical profile,” said Martin Babler, President and Chief Executive Officer of Alumis. “By maximally inhibiting TYK2 to block both IL-23 and IL-17 pathways, envudeucitinib delivered comprehensive disease control with rapid onset of action, high rates of skin clearance, and meaningful symptom improvements in our Phase 3 ONWARD program that reinforce our conviction in envudeucitinib’s potential to transform the psoriasis treatment landscape. We look forward to our clinical topline readout for our potentially pivotal LUMUS Phase 2b trial in SLE, anticipated in the third quarter of this year.”
Babler added, “Importantly, the results of both psoriasis and SLE will potentially unlock envudeucitinib’s pipeline‑in‑a‑pill’ opportunity to leverage maximal TYK2 inhibition across multiple immune‑mediated diseases. Alumis is evaluating additional indications for our TYK2 inhibitors as part of a unified franchise development strategy that we plan to announce in the second quarter of 2026.”
Fourth Quarter 2025 and Recent Highlights
Anticipated 2026 Milestones
Year-end 2025 Financial Results
Financial Guidance
About AlumisAlumis is a late-stage biopharma 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. In addition, the pipeline includes lonigutamab, a subcutaneously delivered anti–insulin-like growth factor 1 receptor therapy for the treatment of thyroid eye disease, as well as several preclinical programs identified through this precision approach. For more information, visitwww.alumis.comor follow us on LinkedIn or X.
Forward Looking StatementsThis 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 a clinical trial, or the timing of clinical data in its ongoing clinical trials, the timing of the Company’s planned NDA submission with the FDA for envudeucitinib in moderate-to-severe plaque psoriasis, the expected timing of each of the Company’s completion of its strategic review for lonigutamab, determination of its next clinical candidate and presentation of its TYK2 franchise strategy, the potential for envudeucitinib to treat moderate-to-severe plaque psoriasis and systemic lupus erythematosus, 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). Alumis explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.
| ALUMIS INC.CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS(Unaudited) | ||||||||
| Year Ended December 31, | ||||||||
| (in thousands) | 2025 | 2024 | ||||||
| Revenue: | ||||||||
| License revenue | $ | 17,389 | $ | — | ||||
| Collaboration revenue | 6,661 | — | ||||||
| Total revenue | 24,050 | — | ||||||
| Operating expenses: | ||||||||
| Research and development expenses | 385,998 | 265,554 | ||||||
| General and administrative expenses | 91,856 | 35,200 | ||||||
| Total operating expenses | 477,854 | 300,754 | ||||||
| Loss from operations | (453,804 | ) | (300,754 | ) | ||||
| Other income (expense): | ||||||||
| Gain on bargain purchase | 187,907 | — | ||||||
| Interest income | 14,180 | 12,020 | ||||||
| Change in fair value of derivative liability | — | (5,406 | ) | |||||
| Other income (expenses), net | (169 | ) | (93 | ) | ||||
| Total other income (expense), net | 201,918 | 6,521 | ||||||
| Net loss before income taxes | (251,886 | ) | (294,233 | ) | ||||
| Income tax benefit | 8,561 | — | ||||||
| Net loss | $ | (243,325 | ) | $ | (294,233 | ) | ||
| Other comprehensive income (loss): | ||||||||
| Unrealized gain (loss) on marketable securities, net | 148 | 38 | ||||||
| Total comprehensive loss | $ | (243,177 | ) | $ | (294,195 | ) |
| ALUMIS INC.CONSOLIDATED BALANCE SHEETS(Unaudited) | ||||||||
| December 31, | December 31, | |||||||
| (in thousands) | 2025 | 2024 | ||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 89,670 | $ | 169,526 | ||||
| Restricted cash | 82 | — | ||||||
| Marketable securities | 218,831 | 118,737 | ||||||
| Research and development prepaid expenses | 2,909 | 13,424 | ||||||
| Other prepaid expenses and current assets | 6,740 | 4,501 | ||||||
| Total current assets | 318,232 | 306,188 | ||||||
| Restricted cash, non-current | 1,301 | 1,106 | ||||||
| Property and equipment, net | 18,190 | 20,968 | ||||||
| Intangible assets | 50,959 | — | ||||||
| Operating lease right-of-use assets, net | 16,971 | 12,723 | ||||||
| Other assets, non-current | 6,287 | 7 | ||||||
| Total assets | $ | 411,940 | $ | 340,992 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 10,106 | $ | 9,624 | ||||
| Research and development accrued expenses | 34,781 | 29,149 | ||||||
| Deferred revenue, current | 1,458 | — | ||||||
| Other accrued expenses and current liabilities | 22,303 | 10,580 | ||||||
| Operating lease liabilities, current | 4,670 | 1,557 | ||||||
| Total current liabilities | 73,318 | 50,910 | ||||||
| Operating lease liabilities, non-current | 32,244 | 29,165 | ||||||
| Deferred revenue, non-current | 2,611 | — | ||||||
| Deferred tax liability | 2,140 | — | ||||||
| Share repurchase liability | 123 | 813 | ||||||
| Other liabilities, non-current | 207 | — | ||||||
| Total liabilities | 110,643 | 80,888 | ||||||
| Stockholders’ equity: | ||||||||
| Preferred stock | — | — | ||||||
| Common stock | 10 | 5 | ||||||
| Additional paid-in capital | 1,202,975 | 918,610 | ||||||
| Accumulated other comprehensive income (loss) | 188 | 40 | ||||||
| Accumulated deficit | (901,876 | ) | (658,551 | ) | ||||
| Total stockholders’ equity | 301,297 | 260,104 | ||||||
| Total liabilities and stockholders’ equity | $ | 411,940 | $ | 340,992 |
Alumis Contact Information
Teri DahlmanRed House Communicationsteri@redhousecomms.com