Core Insights - Alumis Inc. is experiencing strong momentum in its development programs, particularly with the ongoing clinical trials for its TYK2 inhibitor ESK-001, which is expected to yield pivotal Phase 3 data for moderate-to-severe plaque psoriasis in early 2026 [2][4] - The company is focused on the anticipated merger with ACELYRIN, which is expected to enhance its clinical pipeline and financial flexibility, creating value for both patients and stockholders [2][4] - Alumis reported a net loss of $99.0 million for Q1 2025, a significant increase from a loss of $49.8 million in Q1 2024, driven by higher research and development expenses [9][19] Recent Highlights - Alumis entered into a collaboration and licensing agreement with Kaken Pharmaceutical for ESK-001 in Japan, receiving an upfront license fee of $20 million and additional near-term co-development payments [4][9] - The merger agreement with ACELYRIN was approved by Alumis stockholders, with the combined company expected to have a pro forma cash position of approximately $737 million as of December 31, 2024, providing a runway for advancing its pipeline [4][9] - The company plans to initiate a Phase 2 clinical trial for A-005 in multiple sclerosis and finalize the clinical development plan for Lonigutamab following the merger [4][9] Financial Results - For the quarter ended March 31, 2025, Alumis reported total revenue of $17.4 million, primarily from license revenue related to the Kaken collaboration [9][19] - Research and development expenses increased to $96.6 million in Q1 2025 from $42.0 million in Q1 2024, reflecting higher costs associated with clinical trials and increased headcount [9][19] - General and administrative expenses rose to $22.3 million in Q1 2025 from $5.6 million in Q1 2024, mainly due to transaction costs related to the merger and personnel-related expenses [9][19] Anticipated Milestones - Key upcoming milestones include topline data for ESK-001 in psoriasis expected in Q1 2026 and Phase 2b data for systemic lupus erythematosus also expected in 2026 [4][9] - The merger with ACELYRIN is anticipated to close in the second quarter of 2025, which is expected to enhance value creation opportunities for stockholders [4][9]

Core Viewpoint - ACELYRIN, Inc. has received stockholder approval for its merger with Alumis Inc., which is expected to enhance value through the combination of their complementary pipelines and organizations [1][2]. Group 1: Merger Details - The merger agreement stipulates that ACELYRIN stockholders will receive 0.4814 shares of Alumis common stock for each share of ACELYRIN common stock owned at the closing of the transaction [1]. - The transaction is anticipated to be completed in the second quarter of 2025 [3]. Group 2: Company Background - ACELYRIN, Inc. focuses on developing transformative medicines in immunology, with its lead program being lonigutamab, a monoclonal antibody for treating thyroid eye disease [5]. Group 3: Leadership Statements - The CEO of ACELYRIN expressed appreciation for stockholder support, indicating confidence in the merger as a value-maximizing strategy [2].

Core Viewpoint - Alumis Inc. has received stockholder approval for its merger with ACELYRIN, INC., marking a significant step towards closing the transaction and enhancing its capabilities in developing therapies for immune-mediated diseases [1][2][3] Company Overview - Alumis Inc. is a clinical-stage biopharmaceutical company focused on developing oral therapies using a precision approach to improve clinical outcomes for patients with immune-mediated diseases [4] - The company utilizes a proprietary precision data analytics platform to build a pipeline of molecules targeting a wide range of immune-mediated diseases, both as monotherapy and combination therapies [4] - Alumis' leading product candidate, ESK-001, is an oral, selective small molecule inhibitor currently being evaluated for moderate-to-severe plaque psoriasis and systemic lupus erythematosus [4] Merger Details - The merger with ACELYRIN is anticipated to close in the second quarter of 2025, pending the fulfillment of customary closing conditions [3] - Martin Babler, President and CEO of Alumis, expressed gratitude to stockholders for their support and emphasized the goal of maximizing the value of their portfolio post-merger [2] Future Prospects - The merger is expected to provide Alumis with a strengthened financial foundation, enabling the advancement of breakthroughs in the treatment of immune-mediated diseases [2]

Core Viewpoint - ACELYRIN, INC. is urging its stockholders to vote in favor of the proposed merger with Alumis Inc., supported by a recommendation from Institutional Shareholder Services (ISS) [1][2]. Group 1: Proposed Transaction - The special meeting for stockholders to vote on the merger is scheduled for May 13, 2025 [2]. - ISS has recommended that stockholders vote "FOR" the merger, indicating it is the best path to maximize shareholder value [2][3]. - The merger is the result of a comprehensive process led by independent directors, aimed at creating a stronger, diversified company [2]. Group 2: Company Overview - ACELYRIN is a late-stage clinical biopharma company focused on developing transformative medicines in immunology [1][4]. - The company's lead program, lonigutamab, is a monoclonal antibody targeting IGF-1R for treating thyroid eye disease [4]. Group 3: Advisory and Legal Support - Guggenheim Securities, LLC is serving as the financial advisor for ACELYRIN, while Fenwick & West LLP and Paul Hastings LLP are providing legal counsel [3].

Core Viewpoint - ACELYRIN, Inc. expresses confidence that the proposed merger with Alumis Inc. is the best path forward and maximizes value for stockholders [2][3] Company Overview - ACELYRIN is a late-stage clinical biopharma company focused on developing transformative medicines in immunology [2] - The merger with Alumis is seen as a strategic move to create a leading clinical-stage immunology company with a diversified portfolio [8] Merger Details - The ACELYRIN Board recommends stockholders vote "FOR" the merger, emphasizing the importance of every vote [5] - The merger agreement reflects a significant increase in ACELYRIN stockholders' ownership in the combined company, retaining approximately 48% ownership [8] - The merger follows a comprehensive review process by an independent transaction committee [8] Stockholder Engagement - The Board urges stockholders to protect their investment value and not be swayed by short-term focused investors [4] - A Special Meeting of stockholders is scheduled for May 13, 2025, to vote on the merger [1][5] Rights Plan - ACELYRIN adopted a limited duration rights plan in response to a rapid accumulation of its stock by Tang Capital, aiming to maximize stockholder value [6]

Core Viewpoint - The merger between Alumis Inc. and ACELYRIN, INC. has been amended to provide increased ownership for ACELYRIN stockholders, with the revised exchange ratio allowing Alumis stockholders to own approximately 52% and ACELYRIN stockholders to own approximately 48% of the combined company on a fully diluted basis, maximizing potential value for both parties [1][2]. Company Overview - Alumis Inc. is a clinical-stage biopharmaceutical company focused on developing therapies for immune-mediated diseases using a precision approach [10]. - ACELYRIN, INC. is a late-stage clinical biopharma company dedicated to accelerating the development and commercialization of transformative medicines, with its lead program targeting thyroid eye disease [11]. Merger Details - The amended agreement allows ACELYRIN stockholders to receive 0.4814 shares of Alumis common stock for each share of ACELYRIN common stock owned, representing a significant increase in ownership compared to the original merger terms [2]. - The merger is expected to create a leading clinical-stage immunology company with a diversified portfolio of product candidates, enhancing financial flexibility and advancing a late-stage pipeline [5][3]. Financial Position - Alumis reported a pro forma cash position of approximately $737 million as of December 31, 2024, which is expected to support the combined company's pipeline and operational needs into 2027 [5]. - Stockholders representing approximately 62% of Alumis voting common stock and about 24% of ACELYRIN common stock have entered into voting agreements in support of the transaction [6]. Upcoming Events - A Special Meeting of Stockholders for both companies is scheduled for May 13, 2025, where stockholders will vote on the merger [8][7].

Market Overview - The S&P 500 experienced a significant drop of approximately 10% in the first five trading days of April 2025 due to tariffs impacting market stability [1] - Investors with available cash may seek opportunities in companies that have shown resilience amid market volatility [1] Alumis (NASDAQ: ALMS) - Alumis shares surged by 64% in the five trading days leading to April 7, 2025, largely due to the announcement of a proposed merger with Acelyrin Inc. [4] - The merger is expected to consolidate strong pipelines and provide a cash runway through 2027, with multiple clinical readouts anticipated [5] - Current stock price is $8.04, with a 12-month price forecast of $26.00, indicating a potential upside of 223.38% [3] DBV Technologies (NASDAQ: DBVT) - DBV Technologies shares increased by 129% year-to-date as of April 7, 2025, and rose by 17% in the five days leading to that date [7] - The company is developing the VIASKIN peanut patch, which aims to desensitize children to peanut allergies, and has received FDA support for its Biologics License Application [8][9] - Current stock price is $7.07, with a 12-month price forecast of $22.50, suggesting a potential upside of 218.25% [6] Corcept Therapeutics (NASDAQ: CORT) - Corcept's relacorilant has shown promise in treating ovarian cancer, with a late-stage trial indicating it may delay cancer progression in patients resistant to existing chemotherapy [10] - The stock price is currently $72.97, with a 12-month price forecast of $143.25, indicating a potential upside of 96.31% [10] - Corcept's shares have increased nearly 50% year-to-date, despite a recent decline in early April [11]

Stockholders to benefit from differentiated late-stage portfolio of therapies and strong balance sheet Boards unanimously recommend stockholders vote “FOR” the merger Transaction expected to be completed in second quarter of 2025 SOUTH SAN FRANCISCO, Calif. and LOS ANGELES, April 04, 2025 (GLOBE NEWSWIRE) -- Alumis Inc. (Nasdaq: ALMS), a clinical-stage biopharmaceutical company developing therapies using a precision approach to optimize clinical outcomes and significantly improve the lives of patients with ...

- Alumis to receive $40 million in upfront and near-term co-development payments, with potential for approximately $140 million in additional milestone and field option payments, plus tiered royalties on future sales -Deal underscores the commercial potential of Alumis' ESK-001 and leverages Kaken's regional capabilities and expertise in novel dermatology treatments -Kaken has the option to license ESK-001 for further clinical development and commercialization in rheumatological and gastrointestinal disease ...

Merger and Acquisition - The Merger Agreement includes a termination fee of $10.0 million for both parties if the Merger is not completed [208]. - Post-Merger, the pre-Merger stockholders of the company are expected to hold approximately 55% of the combined company's common stock, while ACELYRIN stockholders are expected to hold approximately 45% [221]. - The initiation of ACELYRIN's Phase 3 LONGITUDE program for evaluating subcutaneous lonigutamab in thyroid eye disease is expected to be delayed due to the Merger [216]. - The Merger may not be completed if there is a material adverse effect affecting either party, but certain changes are excluded from this definition [217]. - The pursuit of the Merger may cause existing or prospective partners to delay decisions or reduce business levels, negatively impacting financial results [216]. - Directors and executive officers of both companies have interests in the Merger that may differ from those of other stockholders [223]. - The combined company's stock price may suffer if adverse changes occur before the completion of the Merger [220]. - The company and ACELYRIN have incurred significant expenses related to the Merger, which will be paid regardless of its completion [207]. - The Merger Agreement contains "no-shop" provisions that restrict both parties from soliciting competing acquisition proposals [212]. - The combined company expects to benefit from both companies' product pipelines and market opportunities, but success depends on effective integration and realization of anticipated synergies [229]. - Integration challenges may lead to loss of key employees, disruption of ongoing businesses, and higher than expected integration costs [230]. - Key issues for successful integration include combining operations, reducing unforeseen expenses, and avoiding delays [231]. - The proposed merger with ACELYRIN may require additional financing and could disrupt existing business operations [347]. Financial Condition and Performance - The company has incurred substantial losses, with net losses of $294.2 million and $155.0 million for the years ended December 31, 2024 and 2023, respectively [243]. - The accumulated deficit as of December 31, 2024, was $658.6 million, primarily due to expenses related to pipeline development and general administrative costs [243]. - Future expenses are expected to increase significantly as the company conducts clinical trials and seeks regulatory approvals for product candidates [244]. - Management has substantial doubt about the company's ability to maintain liquidity, raising concerns about its ability to continue as a going concern [257]. - The company has a history of recurring losses and negative cash flows, necessitating additional financing to continue product development until profitability is achieved [257]. - The company may require substantial additional financing to achieve its goals, with potential delays or limitations on product development if funding is not secured [256]. - The financial condition and operational results could be adversely affected by liquidity constraints or failures in financial institutions with which the company has relationships [375]. Clinical Trials and Regulatory Challenges - Clinical trials for product candidates are lengthy and expensive, with high risks of failure and uncertain outcomes [259]. - The company discontinued its Phase 2a clinical trial of ESK-001 due to efficacy results not meeting clinical success thresholds, despite safety results being consistent with prior studies [261]. - The FDA or comparable regulatory authorities may impose additional requirements or disagree with trial designs, potentially delaying clinical trials [266]. - The company has observed serious adverse events (SAEs) and adverse events (AEs) in trials, which could impact regulatory approval and market acceptance of product candidates [270]. - As of December 31, 2024, there were four SAEs related to ESK-001 treatment, including serious infections and malignancies [274]. - The company may face challenges in recruiting participants for clinical trials if atypical or severe side effects are observed [275]. - Regulatory changes in the EU and UK may affect the cost and process of conducting clinical trials, impacting the company's operations [268][269]. - The regulatory approval process for product candidates is lengthy and unpredictable, with significant costs and time involved [312]. - The company may need to conduct additional trials if data from foreign clinical trials are not accepted by the FDA or other regulatory authorities [286]. - The company anticipates ongoing challenges with participant retention and potential withdrawals, which could compromise data quality [255]. Market and Competitive Landscape - The company may face significant challenges in obtaining coverage and adequate reimbursement for its product candidates, impacting revenue generation [288]. - Third-party payors are increasingly challenging prices for biopharmaceutical products, which may limit market acceptance of ESK-001 and A-005 [289]. - The successful commercialization of product candidates will depend on favorable pricing policies and reimbursement levels established by governmental authorities and insurers [288]. - Regulatory approval processes vary significantly across countries, potentially delaying market entry for products outside the United States [287]. - The introduction of new competitor products may trigger mandatory price reductions for existing products, impacting profitability [289]. - The company is developing ESK-001 for the treatment of PsO and SLE, which will face competition from several currently approved or late-stage oral clinical therapeutics [298]. - The company faces substantial competition from larger pharmaceutical and biotechnology companies with greater resources and experience [301]. - Mergers and acquisitions in the industry may concentrate resources among competitors, increasing competitive pressures [302]. - The company must demonstrate that its product candidates are safer, more effective, and more convenient than existing therapies to achieve market penetration [300]. - The market acceptance of product candidates will depend on factors such as safety, efficacy, cost of treatment, and third-party reimbursement availability [329]. Intellectual Property and Legal Risks - Intellectual property protection is critical, and the company relies on patents and confidentiality agreements to safeguard its innovations, but there are uncertainties regarding the effectiveness of these protections [378]. - The patent application process is complex and costly, with no guarantee that pending applications will result in enforceable patents, which could hinder competitive advantage [380]. - The company may face challenges in maintaining patent rights, as third parties could contest the validity of its patents, potentially allowing competitors to enter the market without compensation [386]. - There are risks that third parties may challenge the validity of the company's patents, which could result in patents being narrowed or invalidated [392]. - The company may need to initiate costly litigation to enforce its patent rights, regardless of the outcome [392]. - Compulsory licensing laws in certain countries may compel the company to grant licenses to third parties, potentially impairing its competitive position [395]. - The standards for granting patents by the USPTO and foreign patent offices are not uniformly applied, leading to uncertainty in future patent protection [396]. - The company may not be able to prevent competitors from developing similar products if they are not covered by existing patents [397]. - There is a risk that the company may not identify relevant third-party patents, which could adversely affect its ability to develop and market its product candidates [400]. - Competitors may conduct R&D in jurisdictions where the company lacks patent rights, potentially leading to the development of competing products [401]. Cybersecurity and Operational Risks - The company is vulnerable to cybersecurity threats, including ransomware attacks, which could disrupt operations and lead to significant financial losses [355]. - Security incidents could result in delays in regulatory approval efforts and increase costs to recover or reproduce lost clinical trial data [364]. - The company may incur significant expenses related to security breaches, which may not be fully covered by cyber liability insurance [363]. - The reliance on third-party service providers introduces additional cybersecurity risks that could disrupt business operations [361]. - The company may face legal claims, penalties, and reputational damage as a result of security incidents, adversely affecting business and financial condition [367]. - The company's operations are primarily located in California, making it vulnerable to natural disasters which could significantly disrupt business continuity and financial conditions [368]. - Recent banking failures, including Silicon Valley Bank and Signature Bank, highlight the risk of cash and cash equivalents being exposed to institutional failures, potentially impacting liquidity [372]. - The company maintains insurance coverage deemed appropriate, but there is no assurance that it will be sufficient to cover damages from incidents affecting operations [368]. Future Growth and Strategic Direction - The company may forgo opportunities with potentially more profitable product candidates due to limited financial and managerial resources [333]. - As of December 31, 2024, the company had 168 full-time employees and plans to expand its workforce to support development and commercialization efforts [334]. - Future growth may depend on the ability to operate in foreign markets, which entails additional regulatory burdens and uncertainties [342]. - Recent changes to U.S. tax laws, including a 15% minimum tax on book income for large corporations, could materially affect the company's tax obligations [351]. - The company has U.S. federal net operating loss carryforwards of $101.2 million and state net operating loss carryforwards of $4.7 million as of December 31, 2024 [348]. - The company faces potential limitations on the use of net operating loss carryforwards due to ownership changes, which could increase future tax obligations [349].