SOUTH SAN FRANCISCO, Calif., Nov. 13, 2025 (GLOBE NEWSWIRE) -- Alumis Inc. (NASDAQ:ALMS), a clinical-stage biopharmaceutical company developing next-generation targeted therapies for patients with immune-mediated diseases, today reported financial results for the quarter ended September 30, 2025, and highlighted recent achievements.
"As we continue to advance our pipeline, we are entering an important period for Alumis. Our teams have been working diligently, and we are eagerly anticipating key milestones ahead - with topline Phase 3 ONWARD data for envudeucitinib (envu) in moderate-to-severe plaque psoriasis (PsO) expected to be announced early in the first quarter of 2026, followed by topline Phase 2b LUMUS data in systemic lupus erythematosus (SLE) in the third quarter," said Martin Babler, President and Chief Executive Officer of Alumis. "These data readouts have the potential to validate envu's differentiated profile and unlock broader opportunities across immune-mediated diseases—representing meaningful inflection points for both the company and the patients we aim to serve."
Babler added, "Our robust pipeline, spanning late-stage, clinical programs and advanced preclinical candidates, reflects the strength of our precision immunology R&D platform and our mission to transform the treatment landscape for immune-mediated diseases. Leveraging a validated mechanism with broad therapeutic potential, our two next-generation oral TYK2 inhibitor programs position us well to advance on this mission."
Third Quarter 2025 and Recent Highlights
Anticipated Milestones
Third Quarter 2025 Financial Results
Financial Guidance
About Alumis
Alumis 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 (or envu, 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 for the treatment of neuroinflammatory and neurodegenerative diseases. 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, 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 "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. All statements, other than statements of historical facts, including without limitation those regarding the timing of Alumis' topline readouts in its Phase 3 ONWARD program and Phase 2b LUMUS clinical trial, the potential for envudeucitinib to treat moderate-to-severe plaque psoriasis and systemic lupus erythematosus, any expectations regarding the safety, efficacy or tolerability of envudeucitinib 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. 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 envudeucitinib or its other programs 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 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 INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Unaudited) | ||||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| (in thousands) | 2025 | 2024 | 2025 | 2024 | ||||||||||||
| Revenue: | ||||||||||||||||
| License revenue | $ | — | $ | — | $ | 17,389 | $ | — | ||||||||
| Collaboration revenue | 2,066 | — | 4,732 | — | ||||||||||||
| Total revenue | 2,066 | — | 22,121 | — | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development expenses | 97,836 | 87,824 | 303,213 | 178,350 | ||||||||||||
| General and administrative expenses | 19,522 | 10,575 | 76,267 | 23,782 | ||||||||||||
| Total operating expenses | 117,358 | 98,399 | 379,480 | 202,132 | ||||||||||||
| Loss from operations | (115,292 | ) | (98,399 | ) | (357,359 | ) | (202,132 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Gain on bargain purchase | — | — | 187,907 | — | ||||||||||||
| Interest income | 4,594 | 5,322 | 10,633 | 8,153 | ||||||||||||
| Change in fair value of derivative liability | — | — | — | (5,406 | ) | |||||||||||
| Other income (expenses), net | (54 | ) | (40 | ) | (136 | ) | (89 | ) | ||||||||
| Total other income (expense), net | 4,540 | 5,282 | 198,404 | 2,658 | ||||||||||||
| Net loss before income taxes | (110,752 | ) | (93,117 | ) | (158,955 | ) | (199,474 | ) | ||||||||
| Income tax benefit | — | — | 8,561 | — | ||||||||||||
| Net loss | $ | (110,752 | ) | $ | (93,117 | ) | $ | (150,394 | ) | $ | (199,474 | ) | ||||
| Other comprehensive income (loss): | ||||||||||||||||
| Unrealized gain (loss) on marketable securities, net | 212 | 140 | 194 | 137 | ||||||||||||
| Total comprehensive loss | $ | (110,540 | ) | $ | (92,977 | ) | $ | (150,200 | ) | $ | (199,337 | ) | ||||
| ALUMIS INC. CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) | ||||||||
| September 30, | December 31, | |||||||
| (in thousands) | 2025 | 2024 | ||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 65,257 | $ | 169,526 | ||||
| Marketable securities | 312,467 | 118,737 | ||||||
| Research and development prepaid expenses | 4,955 | 13,424 | ||||||
| Other prepaid expenses and current assets | 10,611 | 4,501 | ||||||
| Total current assets | 393,290 | 306,188 | ||||||
| Restricted cash, non-current | 1,372 | 1,106 | ||||||
| Property and equipment, net | 19,058 | 20,968 | ||||||
| Intangible assets | 50,959 | — | ||||||
| Operating lease right-of-use assets, net | 17,511 | 12,723 | ||||||
| Other assets, non-current | 5,824 | 7 | ||||||
| Total assets | $ | 488,014 | $ | 340,992 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 4,554 | $ | 9,624 | ||||
| Research and development accrued expenses | 37,629 | 29,149 | ||||||
| Other accrued expenses and current liabilities | 18,821 | 10,580 | ||||||
| Operating lease liabilities, current | 4,412 | 1,557 | ||||||
| Total current liabilities | 65,416 | 50,910 | ||||||
| Operating lease liabilities, non-current | 33,385 | 29,165 | ||||||
| Deferred revenue, non-current | 1,944 | — | ||||||
| Deferred income tax liability | 2,140 | — | ||||||
| Share repurchase liability | 187 | 813 | ||||||
| Other liabilities, non-current | 169 | — | ||||||
| Total liabilities | 103,241 | 80,888 | ||||||
| Stockholders' equity: | ||||||||
| Preferred stock | — | — | ||||||
| Common stock | 10 | 5 | ||||||
| Additional paid-in capital | 1,193,474 | 918,610 | ||||||
| Accumulated other comprehensive income (loss) | 234 | 40 | ||||||
| Accumulated deficit | (808,945 | ) | (658,551 | ) | ||||
| Total stockholders' equity | 384,773 | 260,104 | ||||||
| Total liabilities and stockholders' equity | $ | 488,014 | $ | 340,992 | ||||
Alumis Contact Information Teri Dahlman Red House Communications teri@redhousecomms.com