Alumis Reports Third Quarter 2025 Financial Results and Highlights Recent Progress

Rhea-AI Summary

Alumis (Nasdaq: ALMS) reported third quarter 2025 results and program milestones on Nov 13, 2025. Cash, cash equivalents and marketable securities were $377.7 million as of Sept 30, 2025, which the company expects will fund operations into 2027. Revenue for the quarter included $2.1 million of collaboration revenue. R&D expense was $97.8 million and G&A was $19.5 million for Q3 2025; net loss was $110.8 million. Key clinical milestones: topline Phase 3 ONWARD envudeucitinib (PsO) data expected early Q1 2026 and Phase 2b LUMUS (SLE) topline in Q3 2026; A-005 Phase 2 MS start planned H1 2026.

Positive

• Cash balance of $377.7M as of Sept 30, 2025
• Cash runway expected to fund operations into 2027
• Topline Phase 3 ONWARD envu data expected early Q1 2026

Negative

• Net loss of $110.8M in Q3 2025 (up from $93.1M)
• R&D expense increased to $97.8M in Q3 2025 (+~11% YoY)
• Merger-related expenses of $40.8M for nine months ended Sept 30, 2025

Insights

Senior biotech analyst

Alumis shows clear clinical milestones and solid cash runway, offset by rising R&D spend and widening quarterly loss.

Alumis advances several late‑stage programs with concrete topline readouts expected: ONWARD Phase 3 envudeucitinib data early in the first quarter of 2026, LUMUS Phase 2b SLE topline in the third quarter of 2026, and a planned Phase 2 start for A-005 in the first half of 2026. The company reported $377.7 million in cash and marketable securities as of September 30, 2025, and expects this balance to fund operations into 2027, which aligns available resources with the announced clinical milestones.

Risks and dependencies are explicit and operational: sequential increases in research and development and general and administrative expenses drove a larger net loss of $110.8 million for the quarter, and merger-related charges materially contributed to 2025 costs. The readouts themselves will determine value inflection; until topline efficacy/safety outcomes and subsequent regulatory or commercial steps are disclosed, clinical risk and execution risk remain primary uncertainties.

Monitor the ONWARD topline in early Q1 2026, the LUMUS topline in Q3 2026, and quarterly cash‑burn trends versus the stated runway into 2027. Near term, assess whether R&D spending stabilizes after the merger‑related items and whether the company confirms a once‑daily formulation in 2025, as these operational details affect development pacing and capital durability.

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

• Envudeucitinib, a highly selective, next-generation oral tyrosine kinase 2 (TYK2) inhibitor for the treatment of immune-mediated diseases, including PsO and SLE
  • The Journal of the American Academy of Dermatology (JAAD) has published two separate manuscripts describing results from the Phase 2 STRIDE clinical trial in moderate-to-severe PsO in which data demonstrate sustained or increasing response rates and a well-tolerated safety profile supporting envu’s potential to offer a differentiated profile for the treatment of moderate-to-severe plaque psoriasis:
    • “Safety and efficacy of envudeucitinib, a highly selective, oral allosteric TYK2 inhibitor, in patients with moderate-to-severe plaque psoriasis: Results from the 52-week open-label extension period of the phase 2 STRIDE study” published in October
    • “Highly selective, allosteric inhibition of TYK2 with oral ESK-001 in patients with moderate-to-severe plaque psoriasis: Results from STRIDE, a 12-week, randomized, double-blinded, placebo-controlled, dose-ranging phase 2 study” published in July
• A-005, a potentially first-in-class fully CNS-penetrant oral TYK2 inhibitor for the treatment of neuroinflammatory and neurodegenerative diseases
  • A poster presentation entitled “Pharmacokinetics, pharmacodynamics and CNS penetration of A-005: a novel TYK2 inhibitor for MS” was given at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Congress demonstrating a favorable pharmacokinetic profile, maximal TYK2 inhibition and the ability to cross the blood-brain barrier while being well-tolerated with no serious adverse events, supporting a planned Phase 2 clinical trial in multiple sclerosis.
• Lonigutamab, next-generation subcutaneous anti-IGF-1R therapy for the treatment of thyroid eye disease (TED)
  • A poster presentation entitled “Safety, efficacy and quality of life outcomes of subcutaneous lonigutamab (anti-IGF-1R): Week 12 results from a Phase 1/2 proof of concept study in patients with thyroid eye disease” was given at the annual meeting of the American Society of Ophthalmic Plastic and Reconstructive Surgery (ASOPRS) highlighting the differentiated mechanism of action, safety profile and potential of lonigutamab in TED.

Anticipated Milestones

• • Envu: topline data from ONWARD1 and ONWARD2 in moderate-to-severe plaque psoriasis are expected early in the first quarter of 2026.
  • Envu: topline data from LUMUS in SLE are expected in the third quarter of 2026.
  • Envu: Alumis expects to establish a once-daily formulation in 2025.
  • A-005: initiation of a Phase 2 clinical trial in multiple sclerosis is anticipated in the first half of 2026.
  • Lonigutamab: the lonigutamab development program continues to be evaluated.
  • Third internally-developed program: Phase 1 clinical data is anticipated in the second half of 2026.

Third Quarter 2025 Financial Results

• As of September 30, 2025, Alumis had cash, cash equivalents and marketable securities of $377.7 million.
• Revenue included collaboration revenue of $2.1 million for the quarter ended September 30, 2025, related to the collaboration and licensing agreement with Kaken Pharmaceutical Co., Ltd.
• Research and development expenses were $97.8 million for the quarter ended September 30, 2025, compared to $87.8 million for the quarter ended September 30, 2024. The increase was driven by an increase in contract research and clinical trial costs for the envu and other programs, including costs to support acceleration of clinical trial activities for the Phase 3 ONWARD program, as well as severance costs and stock-based compensation expense related to the merger with ACELYRIN, and increased headcount in research and development teams to support development efforts. The quarter ended September 30, 2024 included a clinical milestone payment of $23.0 million related to the prior acquisition of FronThera.
• General and administrative expenses were $19.5 million for the quarter ended September 30, 2025, compared to $10.6 million for the quarter ended September 30, 2024. The increase was primarily attributable to severance costs and stock-based compensation expense related to the merger with ACELYRIN, and personnel-related expenses and professional consulting services to support the Company’s growth.
• Net loss was $110.8 million for the quarter ended September 30, 2025, compared to a net loss of $93.1 million for the quarter ended September 30, 2024.
• The Company recognized total expenses related to the merger with ACELYRIN of $6.3 million and $40.8 million for the three and nine months ended September 30, 2025, respectively, of which $2.8 million and $30.6 million related to general and administrative expenses for the three and nine months ended September 30, 2025, respectively, and $3.5 million and $10.2 million related to research and development expenses for the three and nine months ended September 30, 2025. These merger-related expenses included stock-based compensation expense of $2.1 million and $12.9 million for the three and nine months ended September 30, 2025, respectively, related to accelerated vesting of equity awards and a stock option post-termination exercise period modification for severed employees.

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 September 30, 2025 is expected to support advancement of its pipeline through multiple planned key clinical data readouts and to fund operating expenses and capital expenditure requirements into 2027.
  
  

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

FAQ

When will Alumis (ALMS) announce topline Phase 3 ONWARD envudeucitinib psoriasis data?

Alumis expects topline ONWARD data for envudeucitinib in moderate-to-severe plaque psoriasis early in Q1 2026.

What cash runway did Alumis (ALMS) report on Nov 13, 2025 and how long should it last?

As of Sept 30, 2025 Alumis reported $377.7 million in cash and marketable securities, which it expects to fund operations into 2027.

What were Alumis (ALMS) Q3 2025 R&D and net loss figures?

Q3 2025 research and development expense was $97.8 million and net loss was $110.8 million.

When does Alumis (ALMS) expect topline Phase 2b LUMUS data in SLE?

Alumis expects topline LUMUS data in systemic lupus erythematosus in the third quarter of 2026.

What near-term clinical starts did Alumis (ALMS) announce for 2026?

Alumis anticipates initiating A-005 Phase 2 in multiple sclerosis in H1 2026 and expects Phase 1 data from a third program in H2 2026.