ACELYRIN stockholders to receive increased ownership in the combined company through revised exchange ratio; Alumis and ACELYRIN stockholders to now own approximately 52% and 48%, respectively, of the combined company on a fully diluted basis Merger maximizes the potential value for ACELYRIN stockholders and creates a stronger combined company, best-positioned to realize long-term value of multiple late-stage assets ACELYRIN files investor presentation highlighting benefits of proposed merger and comprehen ...

With tariffs sending markets reeling in the first days of the second quarter—the S&P 500 dropped roughly 10% in the five trading periods through Apr. 7, 2025—investors with cash to spend might be looking for an opportunity. While it's true that some of the biggest firms in the world started April with major share price discounts, investors may want to find companies to target that have been more or less bulletproof in the extreme uncertainty characterizing the market. Three biopharmaceuticals firms—Alumis N ...

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].

Merger Agreement Details - The merger agreement is dated February 6, 2025, between Alumis Inc., Arrow Merger Sub, Inc., and ACELYRIN, Inc.[7] - The merger will result in the cancellation of each outstanding share of common stock of ACELYRIN, with shareholders entitled to receive the merger consideration[9] - The merger is intended to qualify as a "reorganization" for U.S. federal income tax purposes under Section 368(a) of the Code[10] - The closing of the merger will occur on the third business day after the last conditions are satisfied or waived[13] - The effective time of the merger will be when the Certificate of Merger is filed with the Secretary of State of Delaware[15] - The certificate of incorporation of ACELYRIN will be amended and restated to become the certificate of incorporation of the surviving corporation[16] - The bylaws of ACELYRIN will be amended to conform to the bylaws of Arrow Merger Sub[17] - The directors of Arrow Merger Sub will become the directors of the surviving corporation after the merger[18] - The officers of Arrow Merger Sub will serve as the officers of the surviving corporation post-merger[19] - The merger is deemed advisable and in the best interests of both companies and their stockholders as per the resolutions adopted by their respective boards[9] Share Conversion and Options - Each share of the Company will be converted into the right to receive 0.4274 shares of Parent Common Stock as part of the Merger Consideration[21] - All shares, except Excluded Shares, will cease to exist and will be cancelled without payment of any consideration[22] - Each Company Option with an exercise price of $18.00 or less will be converted into an option award to purchase shares of Parent Common Stock, while options with an exercise price above $18.00 will be cancelled without payment[36] - Each unvested Company RSU will be converted into a restricted stock unit award with respect to shares of Parent Common Stock, maintaining the same terms and conditions[37] Exchange and Claims - The Exchange Agent will handle the exchange of shares and will issue cash in lieu of fractional shares, with no interest paid on any amounts[26] - Any portion of the Exchange Fund that remains unclaimed for 180 days after the Effective Time will be delivered to Parent[31] - The Merger Consideration will be adjusted to prevent dilution in case of changes in the number of shares or securities prior to the Effective Time[34] - Holders of Uncertificated Shares will not need to deliver a Certificate to receive the Merger Consideration[33] - The Exchange Agent will aggregate fractional shares and sell them in the open market, providing cash to holders instead of issuing fractional shares[29] - Any lost, stolen, or destroyed Certificates can be replaced upon the making of an affidavit and possibly posting a bond[32] Company Financials and Compliance - At the close of business on January 31, 2025, 100,702,249 Shares were issued and outstanding, with no shares of Company Preferred Stock issued[55] - 21,461,518 Shares were reserved for issuance pursuant to the Company Stock Plans, including 13,644,034 Shares for outstanding Company Options, 3,142,891 Shares for outstanding Company RSUs, and 640,746 Shares for outstanding Company PSUs[55] - 1,675,454 Shares were reserved for issuance pursuant to the Company ESPP[55] - The Company will terminate the Company ESPP immediately prior to the Effective Time[42] - Converted Performance RSUs will vest in three equal installments on May 15 of calendar years 2025, 2026, and 2027, subject to the holder remaining in service[39] - Parent will prepare and file a Form S-8 with the SEC to register shares of Parent Common Stock necessary to fulfill obligations under the Company Equity Awards[41] - No appraisal rights shall be available to holders of Shares in connection with the Merger[44] - The Company has filed all required SEC documents since May 9, 2023, ensuring compliance with SOX and the Exchange Act[67] - The consolidated financial statements included in the SEC documents fairly present the Company's financial position and results of operations[68] - The Company maintains a system of internal control over financial reporting to ensure compliance with GAAP[71] Legal and Regulatory Compliance - The Company is in compliance with all applicable laws and permits, with no significant legal proceedings pending[81] - The Company has no outstanding liabilities that would reasonably be expected to have a material adverse effect[80] - The Company is not a party to any unfiled material contracts that are required to be disclosed[82] - The Company has contracts requiring cash payments exceeding $3,000,000 for the fiscal years ending December 31, 2024, and December 31, 2025[83] - The Company is obligated to make capital investments or expenditures exceeding $500,000[83] - The Company has contracts that materially restrict its ability to compete in any business or geographical area[84] - The Company has legal proceedings involving payments exceeding $500,000[85] - The Company has no material breaches or defaults under any Company Material Contracts[88] - All Company Plans are in compliance with applicable laws and have been operated in accordance with their terms[91] - The Company has made all required contributions and payments for each Company Plan[93] Employment and Labor Compliance - The Company has provided a complete list of current employees, including compensation and employment status[102] - All employees are employed on an at-will basis, with no guaranteed continued employment[103] - The Company has been in compliance with all applicable labor and employment laws since January 1, 2022, with no legal proceedings related to labor matters reported[104] - The Company has not engaged in any mass layoffs or employment actions requiring advance notice under the WARN Act in the past 90 days[107] - The Company has not been involved in any collective bargaining agreements with labor unions, and there are no ongoing labor disputes[106] Intellectual Property and Privacy Compliance - The Company owns all material intellectual property rights free of liens, and has valid agreements in place to protect its trade secrets and confidential information[127] - No claims of discrimination or harassment have been made against senior directors or above, and no investigations or settlements have occurred regarding such claims[108] - The Company has maintained compliance with environmental laws and holds all necessary permits and licenses[109] - The Company has not received any written claims alleging infringement of third-party intellectual property rights since January 1, 2022[130] - The Company and its Subsidiaries have complied with all applicable Privacy Laws and Company Privacy Requirements since January 1, 2022, without any material adverse effect[135] - The Company has implemented appropriate measures to protect Personal Information and has not experienced any Security Incidents requiring notification since January 1, 2022[136] - Since January 1, 2022, the Company has not received any communications alleging material violations of applicable Company Privacy Requirements[137] - The Company and its Subsidiaries hold all necessary permits and licenses required to conduct their business, which are in full force and effect[138] - The Company has been in compliance with all Healthcare Laws and has not received any notices of noncompliance from Governmental Entities since January 1, 2022[141] - The Company has not been subject to any investigations or enforcement actions by the FDA or other Governmental Entities regarding material facts or compliance issues[142] - The Company has conducted all studies and trials in accordance with applicable laws and has not received any notices requiring termination or modification of such trials since January 1, 2022[143] - The Company maintains valid insurance policies that are in full force and effect, with no claims pending that have been denied or disputed by insurers[147] - The Company has not engaged in any actions that would violate Anti-Corruption and Anti-Bribery Laws since January 1, 2022[146] Parent Company Financials and Compliance - As of January 31, 2025, 47,222,419 shares of Parent Common Stock were issued and outstanding, with 7,184,908 shares of Parent Non-Voting Common Stock also issued and outstanding[161] - No shares of Parent Preferred Stock were issued and outstanding as of January 31, 2025[161] - 1,194,073 shares of Parent Common Stock were reserved for the 2024 Employee Stock Purchase Plan, and 19,072,671 shares were reserved for Parent Stock Plans, including 9,525,649 shares for outstanding Parent Stock Options[161] - Parent has filed all required SEC documents since July 1, 2024, ensuring compliance with SOX and the Exchange Act[175] - Each consolidated financial statement included in the Parent SEC Documents fairly presented the consolidated financial position of Parent and its subsidiaries[176] - Parent maintains a system of internal control over financial reporting sufficient to provide reasonable assurance regarding the preparation of financial statements in conformity with GAAP[179] - Parent is in compliance with applicable Nasdaq listing and corporate governance rules[180] - The Parent Special Committee has determined that the merger agreement is advisable and in the best interests of Parent and its stockholders[168] - No shares of capital stock or voting securities of Parent were issued or reserved for issuance other than those mentioned above[165] - Parent has no outstanding obligations to repurchase or redeem any shares of capital stock or voting securities[165] - Parent has maintained disclosure controls and procedures since July 1, 2024, ensuring timely and accurate reporting of financial and non-financial information[181] - There have been no material adverse effects on Parent or its subsidiaries since the date of the Parent Balance Sheet[183] - Parent's business has been conducted in the ordinary course consistent with past practices since the date of the Parent Balance Sheet[185] - No legal proceedings have been pending or threatened against Parent or its subsidiaries that would result in material liabilities[186] - Parent has no liabilities or obligations that would reasonably be expected to have a material adverse effect, except as reflected in the consolidated unaudited balance sheet as of September 30, 2024[187] - Parent and its subsidiaries are in compliance with all applicable laws and permits, with no significant legal challenges reported since January 1, 2022[188] - Parent is not a party to any material contracts that have not been filed as required under the Securities Act[190] - Parent has no pending or threatened legal proceedings related to its employee plans or labor matters[199] - Parent has complied with all labor and employment laws since January 1, 2022, with no significant legal proceedings reported[199]

– Presented Phase 2 STRIDE OLE 52-week psoriasis data at AAD 2025 demonstrating next-generation oral TYK2 inhibitor ESK-001 treatment led to robust long-term clinical responses and was well tolerated; Phase 3 ONWARD program data readout now expected 1Q 2026 – – Presented Phase 1 clinical data at ACTRIMS 2025 demonstrating first-in-class oral TYK2 inhibitor A-005 has ability to cross blood-brain barrier and was well tolerated; Phase 2 in MS to begin 2H 2025 – – Announced merger agreement with ACELYRIN to cre ...

SOUTH SAN FRANCISCO, Calif., March 10, 2025 (GLOBE NEWSWIRE) -- Alumis Inc. (Nasdaq: ALMS), a clinical-stage biopharmaceutical company developing oral therapies using a precision approach to optimize clinical outcomes and significantly improve the lives of patients with immune-mediated diseases, today announced that Martin Babler, President and Chief Executive Officer of Alumis, will participate in a fireside chat at Leerink's 2025 Global Healthcare Conference on Tuesday, March 11, 2025 at 10:40 am ET. A li ...

ESK-001 is a highly selective, next-generation oral tyrosine kinase 2 (TYK2) inhibitor currently under development in moderate-to-severe plaque psoriasis and systemic lupusPhase 2 OLE data of ESK-001 at 40 mg BID demonstrated sustained or increasing clinical responses through week 52 on PASI 90, PASI 100, and sPGA 0ESK-001 was generally well-tolerated at one year, with no new safety findingsData further support ESK-001's potential to offer a highly differentiated and best-in-class treatment option for peopl ...

Combined company to benefit from differentiated late-stage portfolio of therapies and strong balance sheetSOUTH SAN FRANCISCO, Calif. and LOS ANGELES, March 04, 2025 (GLOBE NEWSWIRE) -- Alumis Inc. (Nasdaq: ALMS) (“Alumis”) and ACELYRIN, INC. (Nasdaq: SLRN) (“ACELYRIN”) today reaffirmed their commitment to merge in an all-stock transaction, which will create a leading clinical stage biopharma company in immune-mediated diseases. Martin Babler, President, Chief Executive Officer and Chairman of Alumis, said, ...