–Completed enrollment in Phase 3 ONWARD clinical trials for envudeucitinib in moderate-to-severe plaque psoriasis; topline readout expected in early Q1 2026–
–Completed enrollment in Phase 2b LUMUS clinical trial for envudeucitinib in systemic lupus erythematosus (SLE); topline readout expected in Q3 2026–
–Completed merger with ACELYRIN, Inc. to strengthen financial position and support advancement of late-stage immunology pipeline–
–Cash, cash equivalents and marketable securities of $486.3 million as of June 30, 2025 expected to fund operations into 2027–
SOUTH SAN FRANCISCO, Calif., Aug. 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 June 30, 2025, and highlighted recent achievements and upcoming milestones.
"With patient enrollment now complete in the pivotal Phase 3 ONWARD program for plaque psoriasis and the Phase 2b LUMUS trial in SLE, Alumis has achieved key clinical milestones for envudeucitinib, or "envu" (formerly known as ESK-001), and we look forward to topline data from ONWARD expected in early Q1 2026, and LUMUS topline data expected to follow in Q3 2026," said Martin Babler, President and Chief Executive Officer of Alumis. "We continue to move forward on all fronts with momentum and a clear focus on advancing a differentiated pipeline of immune-mediated treatments. With the completion of our merger with ACELYRIN, we are well positioned to drive our programs through key inflection points in the next 12 months."
Second Quarter 2025 and Recent Highlights, and Anticipated Milestones
Envudeucitinib Progress
Pipeline Updates
Corporate Highlights
Second Quarter 2025 Financial Results
Financial Guidance
Upcoming Events
Alumis expects to participate in the following investor conferences in September 2025:
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 and Phase 2b LUMUS programs, the potential for envudeucitinib to treat moderate-to-severe plaque psoriasis and systemic lupus erythematosus, the timing of Alumis' evaluation of its lonigutamab program, any expectations regarding the safety, efficacy or tolerability of envudeucitinib and statements regarding Alumis' future plans and prospects, including development of its clinical pipeline; 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 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 June 30, | Six Months Ended June 30, | |||||||||||||||
| (in thousands) | 2025 | 2024 | 2025 | 2024 | ||||||||||||
| Revenue: | ||||||||||||||||
| License revenue | $ | — | $ | — | $ | 17,389 | $ | — | ||||||||
| Collaboration revenue | 2,666 | — | 2,666 | — | ||||||||||||
| Total revenue | 2,666 | — | 20,055 | — | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development expenses | 108,755 | 48,565 | 205,377 | 90,526 | ||||||||||||
| General and administrative expenses | 34,450 | 7,575 | 56,745 | 13,207 | ||||||||||||
| Total operating expenses | 143,205 | 56,140 | 262,122 | 103,733 | ||||||||||||
| Loss from operations | (140,539 | ) | (56,140 | ) | (242,067 | ) | (103,733 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Gain on bargain purchase | 187,907 | — | 187,907 | — | ||||||||||||
| Interest income | 3,430 | 1,977 | 6,039 | 2,831 | ||||||||||||
| Change in fair value of derivative liability | — | (2,311 | ) | — | (5,406 | ) | ||||||||||
| Other income (expenses), net | (38 | ) | (34 | ) | (82 | ) | (49 | ) | ||||||||
| Total other income (expense), net | 191,299 | (368 | ) | 193,864 | (2,624 | ) | ||||||||||
| Net income (loss) before income taxes | 50,760 | (56,508 | ) | (48,203 | ) | (106,357 | ) | |||||||||
| Income tax benefit | 8,561 | — | 8,561 | — | ||||||||||||
| Net income (loss) | $ | 59,321 | $ | (56,508 | ) | $ | (39,642 | ) | $ | (106,357 | ) | |||||
| Other comprehensive income (loss): | ||||||||||||||||
| Unrealized gain (loss) on marketable securities, net | 30 | — | (18 | ) | (3 | ) | ||||||||||
| Net income (loss) and other comprehensive income (loss) | $ | 59,351 | $ | (56,508 | ) | $ | (39,660 | ) | $ | (106,360 | ) | |||||
| ALUMIS INC. CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) | ||||||||
| June 30, | December 31, | |||||||
| (in thousands) | 2025 | 2024 | ||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 151,753 | $ | 169,526 | ||||
| Restricted cash | 367 | — | ||||||
| Marketable securities | 334,568 | 118,737 | ||||||
| Research and development prepaid expenses | 7,009 | 13,424 | ||||||
| Other prepaid expenses and current assets | 23,861 | 4,501 | ||||||
| Total current assets | 517,558 | 306,188 | ||||||
| Restricted cash, non-current | 1,382 | 1,106 | ||||||
| Property and equipment, net | 20,328 | 20,968 | ||||||
| Intangible assets | 50,959 | — | ||||||
| Operating lease right-of-use assets, net | 18,223 | 12,723 | ||||||
| Other assets, non-current | 2,475 | 7 | ||||||
| Total assets | $ | 610,925 | $ | 340,992 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 14,981 | $ | 9,624 | ||||
| Research and development accrued expenses | 43,731 | 29,149 | ||||||
| Other accrued expenses and current liabilities | 22,805 | 10,580 | ||||||
| Operating lease liabilities, current | 4,058 | 1,557 | ||||||
| Total current liabilities | 85,575 | 50,910 | ||||||
| Operating lease liabilities, non-current | 34,718 | 29,165 | ||||||
| Deferred revenue, non-current | 2,611 | — | ||||||
| Deferred income tax liability | 2,140 | — | ||||||
| Share repurchase liability | 386 | 813 | ||||||
| Other liabilities, non-current | 168 | — | ||||||
| Total liabilities | 125,598 | 80,888 | ||||||
| Stockholders' equity: | ||||||||
| Preferred stock | — | — | ||||||
| Common stock | 10 | 5 | ||||||
| Additional paid-in capital | 1,183,488 | 918,610 | ||||||
| Accumulated other comprehensive income (loss) | 22 | 40 | ||||||
| Accumulated deficit | (698,193 | ) | (658,551 | ) | ||||
| Total stockholders' equity | 485,327 | 260,104 | ||||||
| Total liabilities and stockholders' equity | $ | 610,925 | $ | 340,992 | ||||
Alumis Contact Information Teri Dahlman Red House Communications teri@redhousecomms.com