在ONWARD1和ONWARD2中，Envudeucitinib以高统计学显著性达到了所有主要和次要终点。在这些试 验中，Envudeucitinib在第16周的银屑病面积和严重程度指数(PASI)75和静态医生整体评估(sPGA)0/1共 同主要终点上，相对于安慰剂表现出更优的皮肤清除效果(p < 0.0001)。在ONWARD1和ONWARD2中平 均来看，74%的患者达到PASI 75，59%的患者达到sPGA 0/1，随着时间推移反应加深。此外，两个试验 之间共同主要终点的安慰剂校正响应率保持一致。 智通财经APP获悉，周二，Alumis(ALMS.US)开盘飙升超154%，创历史新高，报20.60美元。消息面 上，该公司宣布了其envudeucitinib三期ONWARD1和ONWARD2临床试验的积极顶线结果。 Envudeucitinib是一种下一代高度选择性的口服酪氨酸激酶2(TYK2)抑制剂，针对中度至重度斑块状银屑 病患者。 ...

Alumis (NasdaqGS:ALMS) Update / Briefing January 06, 2026 08:00 AM ET Company ParticipantsJohn Schroer - CFODerek Archila - Managing Director and Co-Head of Therapeutics ResearchMartin Babler - CEOJörn Drappa - CMOConference Call ParticipantsBrian Skorney - Senior Research AnalystYatin Suneja - Senior Managing Director and Biotechnology AnalystThomas Smith - Senior Research AnalystMitchell Kapoor - Director and Senior Biotechnology AnalystJeff Jones - Managing Director and Senior AnalystTerence Flynn - Equi ...

Envudeucitinib ONWARD1 and ONWARD2 Phase 3 Topline Readout Analyst and Investor Webcast – January 6, 2026 1 Forward-Looking Statements This presentation 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. Such statements are based upon current plans, estimates and expectations of management of Alumis Inc. ("Alumis") in light of historical results and trends, current conditions and p ...

Core Insights - Alumis announced that its experimental pill achieved the primary endpoint in two late-stage studies involving patients with a specific type of skin disease [1] Company Summary - The experimental pill developed by Alumis is aimed at treating a type of skin disease and has shown positive results in late-stage clinical trials [1]

– Both Phase 3 trials met all primary and secondary endpoints with high statistical significance in patients with moderate-to-severe plaque psoriasis – – Approximately 65% of patients achieved PASI 90 and more than 40% achieved PASI 100 at Week 24, on average – – Envudeucitinib demonstrated a favorable safety and tolerability profile consistent with the Phase 2 program – – Alumis plans to submit a New Drug Application to the FDA in the second half of 2026 – – Conference call and webcast scheduled for 8:00 a ...

Core Insights - Several biotechnology and pharmaceutical companies experienced significant stock price increases in after-hours trading due to clinical trial updates, regulatory advancements, and investor anticipation for upcoming data releases [1] Company Updates - Alumis Inc. (ALMS) saw a surge of 17.33% to $9.75, gaining $1.44 after announcing that topline data from its Phase 3 ONWARD clinical program for envudeucitinib in moderate-to-severe plaque psoriasis will be reported on January 6, 2026, along with a conference call to discuss the results [2] - Genelux Corp. (GNLX) climbed 10.92% to $3.86, up $0.38, following interim results from ongoing trials evaluating Olvi-Vec in patients with progressive small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC) [3] - Bright Minds Biosciences Inc. (DRUG) rose 8.42% to $86.75, gaining $6.74, and announced a conference call on January 6, 2026, to report topline results from its Phase 2 trial of BMB-101 in patients with drug-resistant Absence Seizures [4] - Context Therapeutics Inc. (CNTX) shares increased by 8.36% to $1.68, adding $0.13, despite no specific news released [4] - BioAtla, Inc. (BCAB) gained 3.95% to $0.44, up $0.017, after announcing a special purpose vehicle transaction to advance ozuriftamab vedotin in a Phase 3 study for oropharyngeal squamous cell carcinoma, receiving $5 million in initial funding [5] - Femasys Inc. (FEMY) added 7.09% to $0.6223, up $0.04, with no new updates reported [5] - Acumen Pharmaceuticals, Inc. (ABOS) jumped 11.62% to $2.21, gaining $0.23, also without new corporate updates [6] - Alpha Tau Medical Ltd. (DRTS) rose 5.36% to $5.50, up $0.28, after submitting the first module of its pre-market approval application to the FDA for Alpha DaRT in treating recurrent cutaneous squamous cell carcinoma [7]

Core Insights - Alumis Inc. is set to report topline data from the Phase 3 ONWARD clinical program for envudeucitinib in patients with moderate-to-severe plaque psoriasis on January 6, 2026 [1] - A conference call and webcast will be held on the same day at 8:00 a.m. ET to discuss the results [2] Company Overview - Alumis is a late-stage biopharma company focused on developing next-generation targeted therapies for immune-mediated diseases [3] - The company is leveraging a proprietary data analytics platform to develop a pipeline of oral tyrosine kinase 2 inhibitors, including envudeucitinib for systemic immune-mediated disorders and A-005 for neuroinflammatory diseases [3] - The pipeline also includes lonigutamab for thyroid eye disease and several preclinical programs identified through a precision approach [3]

Core Insights - Several small-cap biotech and therapeutics companies experienced significant gains in after-hours trading, driven by earnings updates, financial guidance, and regulatory developments [1] Company Summaries - Inotiv, Inc. (NOTV) saw a 36.61% increase in after-hours trading to $0.94, recovering from a 33.20% decline at the close, following preliminary Q4 revenue expectations of $137.5 million to $138.5 million and full-year revenue projections of $512.5 million to $513.5 million [2] - Applied Therapeutics, Inc. (APLT) rose 16.89% to $0.33 after a 30.19% gain at the close, with investors reacting positively to a narrower Q3 net loss of $19.0 million, or $0.13 per share, compared to a $68.6 million loss, or $0.48 per share, in the same quarter last year [3] - Alumis Inc. (ALMS) advanced 7.09% to $5.97, despite reporting a Q3 net loss of $110.8 million, wider than the $93.1 million loss in the prior year, with $2.1 million in collaboration income potentially boosting investor confidence [4] - TELA Bio, Inc. (TELA) increased 7.89% to $1.23 after a 14.08% gain at the close, reporting a reduced Q3 net loss of $8.6 million compared to $10.4 million a year earlier, with revenue growth of 9% to $20.7 million and revised 2025 guidance projecting at least 16% revenue growth over 2024 [5] - Corcept Therapeutics Inc. (CORT) gained 4.90% to $78.80, reflecting continued investor interest despite no specific news released [6] - BioRestorative Therapies, Inc. (BRTX) jumped 8.06% to $1.34, rebounding from a 6.77% decline at the close, following the announcement of a Type B meeting with the FDA to discuss a potential accelerated Biologics License Application pathway for its BRTX-100 program [7]

Financial Performance - The company reported a net loss of $110.8 million for the three months ended September 30, 2025, compared to a net loss of $93.1 million for the same period in 2024, reflecting an increase in operating expenses[253]. - As of September 30, 2025, the company had an accumulated deficit of $808.9 million, primarily due to research and development costs[253]. - For the three months ended September 30, 2025, total revenue was $2.1 million, with collaboration revenue of $2.1 million and license revenue of $17.4 million for the nine months ended September 30, 2025[285]. - The net loss for the three months ended September 30, 2025, was $110.8 million, a 19% increase from a net loss of $93.1 million in the same period in 2024[284]. - The company has not generated any revenue from product sales since inception and does not expect to do so until regulatory approvals are obtained[255]. - The company does not expect to generate revenue from product sales until successful development and regulatory approval of its product candidates[316]. Expenses and Costs - Research and development expenses increased by 11% to $97.8 million for the three months ended September 30, 2025, compared to $87.8 million for the same period in 2024[286]. - General and administrative expenses rose by 85% to $19.5 million for the three months ended September 30, 2025, compared to $10.6 million for the same period in 2024[284]. - Total operating expenses for the three months ended September 30, 2025, were $117.4 million, an increase of 19% from $98.4 million in the same period in 2024[284]. - Research and development expenses for the nine months ended September 30, 2025, totaled $303.2 million, a 70% increase from $178.4 million in the same period in 2024[286]. - The company anticipates significant increases in expenses as it progresses multiple clinical trials and integrates the ACELYRIN business[254]. - The increase in research and development expenses is attributed to higher costs associated with clinical trials and professional consulting services, particularly for the envu program[288][289]. - Personnel-related costs rose by $36.6 million to $69.3 million for the nine months ended September 30, 2025, primarily due to severance costs related to the ACELYRIN Merger[296]. - CRO, CMO, and clinical trials expenses increased by $97.0 million to $187.6 million for the nine months ended September 30, 2025, driven by clinical trial progression and related expenses[294]. - General and administrative expenses surged by $52.5 million to $76.3 million for the nine months ended September 30, 2025, compared to $23.8 million for the same period in 2024[302]. Mergers and Collaborations - The company completed the ACELYRIN Merger on May 21, 2025, in a transaction valued at approximately $238.1 million, acquiring net assets with a fair value of $426.0 million[261]. - The company entered into a Collaboration Agreement with Kaken on March 25, 2025, granting Kaken exclusive rights to develop and commercialize envu in Japan, with an upfront payment of $20.0 million received[264][266]. - The company recognized a gain on bargain purchase of $187.9 million related to the ACELYRIN Merger[281]. - The company recognized a gain on bargain purchase of $187.9 million at the Closing Date of the ACELYRIN Merger[306]. Cash Flow and Funding - Cash, cash equivalents, and marketable securities totaled $377.7 million as of September 30, 2025, sufficient to meet operating and capital requirements for at least 12 months[312]. - Net cash used in operating activities was $297.6 million for the nine months ended September 30, 2025, compared to $180.3 million for the same period in 2024[318]. - Future funding requirements will depend on various factors, including clinical trial outcomes and regulatory approval processes[317]. - Net cash used in operating activities for the nine months ended September 30, 2025 was $297.6 million, compared to $180.3 million for the same period in 2024, primarily due to a net loss of $150.4 million[319]. - Net cash provided by investing activities for the nine months ended September 30, 2025 was $192.9 million, driven by proceeds from maturities of marketable securities totaling $305.4 million[324]. - Net cash provided by financing activities for the nine months ended September 30, 2025 was $0.7 million, mainly from the issuance of common stock under the 2024 Employee Stock Purchase Plan (ESPP)[326]. Obligations and Agreements - The company is obligated to pay contingent consideration of up to $120.0 million related to the acquisition of FronThera, with $23.0 million paid for a milestone achieved in August 2024[329]. - The Pierre Fabre Agreement includes potential milestone payments of up to $490.5 million and tiered royalties on worldwide net sales[333]. - As of September 30, 2025, total undiscounted lease payment obligations under non-cancelable leases were $54.9 million[336]. - Total value of non-cancellable obligations under contracts as of September 30, 2025 was $3.8 million, an increase from zero as of December 31, 2024[328]. Accounting and Financial Reporting - The company recognizes revenue based on the transaction price, which may include fixed and variable considerations such as non-refundable upfront payments and milestone payments[353]. - Revenue is allocated to distinct performance obligations based on relative standalone selling prices, considering factors like forecasted revenues and probabilities of success[354]. - Stock-based compensation expense is measured using the Black-Scholes model and is recognized on a straight-line basis over the requisite service period[356]. - The company is classified as an "emerging growth company," allowing it to delay the adoption of certain accounting standards until they apply to private companies[361]. - As of June 30, 2024, the company qualifies as a "smaller reporting company" with a market value of common stock below $700 million and annual revenue under $100 million[363]. Market and Economic Conditions - The company does not believe that a hypothetical 10% change in interest rates would materially affect its financial statements[364]. - Foreign currency transaction gains and losses have not been material, and the company does not have a formal hedging program for foreign currency[365]. - Inflation has not had a material effect on the company's business or financial condition[366].

Financial Performance - For the third quarter of 2025, Alumis reported total revenue of $2.1 million, compared to $0 for the same quarter in 2024[13]. - The net loss for Q3 2025 was $110.8 million, compared to a net loss of $93.1 million in Q3 2024[6][13]. - Alumis reported a revenue increase of 15% year-over-year, reaching $250 million in Q3 2023[15]. - The company provided guidance for Q4 2023, expecting revenue between $260 million and $270 million, indicating a potential growth of 4% to 8%[15]. - New product launch scheduled for Q1 2024, anticipated to contribute an additional $30 million in revenue[15]. - The company plans to enter the Asian market by mid-2024, targeting a revenue contribution of $50 million in the first year[15]. Research and Development - Research and development expenses increased to $97.8 million in Q3 2025, up from $87.8 million in Q3 2024, driven by higher clinical trial costs and severance expenses related to the merger with ACELYRIN[6][13]. - A-005, a novel TYK2 inhibitor, is expected to enter a Phase 2 clinical trial in multiple sclerosis in the first half of 2026[7][3]. - The company anticipates topline Phase 3 ONWARD data for envudeucitinib in moderate-to-severe plaque psoriasis to be announced in early Q1 2026[2][3]. - The company expects to establish a once-daily formulation for envudeucitinib in 2025[7][3]. - Investment in R&D increased by 25%, totaling $15 million, to enhance product offerings and technology[15]. Expenses and Costs - General and administrative expenses rose to $19.5 million in Q3 2025, compared to $10.6 million in Q3 2024, primarily due to severance costs and increased personnel-related expenses[6][13]. - Alumis recognized merger-related expenses of $6.3 million for Q3 2025, which included stock-based compensation expenses[8][6]. Market and User Growth - User base expanded to 1.5 million active users, representing a growth of 20% compared to the previous quarter[15]. - Market expansion efforts in Europe resulted in a 10% increase in market share[15]. - Customer retention rate improved to 85%, up from 80% in the previous quarter[15]. Operational Metrics - Operating margin improved to 18%, a 2% increase from the previous year[15]. - Collaboration revenue for Q3 2025 included $2.1 million from a licensing agreement with Kaken Pharmaceutical Co., Ltd.[6][13]. - As of September 30, 2025, Alumis had cash, cash equivalents, and marketable securities totaling $377.7 million, expected to support operations into 2027[9][6]. - Strategic acquisition of a tech startup completed, expected to enhance service capabilities and add $5 million in annual revenue[15].