Latest news with #IGF-1R
Business Wire
07-05-2025
- Business
- Business Wire
Viridian Therapeutics Receives FDA Breakthrough Therapy Designation for Veligrotug for the Treatment of Thyroid Eye Disease (TED)
WALTHAM, Mass.--(BUSINESS WIRE)--Viridian Therapeutics, Inc. (Nasdaq: VRDN), a biopharmaceutical company focused on discovering, developing, and commercializing potential best-in-class medicines for serious and rare diseases, today announced that the United States Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to veligrotug ('veli'), the company's lead anti-insulin-like growth factor-1 receptor (IGF-1R) drug candidate for the treatment of TED. Breakthrough Therapy Designation is reserved for drug candidates intended to treat serious or life-threatening conditions that address an unmet need where clinical evidence has indicated they may demonstrate substantial improvement on a clinically significant endpoint over existing therapies. 'The FDA's decision to grant veli Breakthrough Therapy Designation underscores that veli may offer substantial improvement over existing therapies, and we believe it reinforces veli's potential to be a differentiated, treatment-of-choice for patients living with TED,' said Steve Mahoney, Viridian's President and CEO. 'Veli is the only therapy that has demonstrated statistically significant and clinically meaningful improvement and resolution of diplopia in both active and chronic TED. Veli also showed a rapid onset of treatment effect, including an improvement in proptosis response in as few as three weeks after just one infusion. We believe veli will be an important potential new treatment option for patients living with TED, including whose disease is unaddressed by existing therapies. We continue to execute on our planned BLA submission in the second half of 2025 and are excited that this designation supports eligibility for Priority Review as we prepare for our planned U.S. commercial launch in 2026.' THRIVE and THRIVE-2, phase 3 clinical trials in active and chronic TED respectively, comprise the largest pivotal program to date in TED. In both clinical trials, veligrotug met all of its primary and secondary endpoints and was generally well-tolerated. THRIVE-2 was the first global phase 3 clinical trial to demonstrate a statistically significant diplopia response and resolution in chronic TED patients. About Veligrotug Veligrotug is an intravenously (IV) delivered, anti-insulin-like growth factor-1 receptor (IGF-1R) antibody in phase 3 development for thyroid eye disease, with the potential to be the IV treatment-of-choice for active and chronic TED patients. IGF-1R is a clinically and commercially validated target for thyroid eye disease (TED) with U.S. revenues of approximately $2 billion in 2024. Veligrotug has the potential to improve patient experience with a differentiated dosing regimen that features a shorter infusion time and fewer infusions compared to the currently approved and marketed IGF-1R inhibitor. In its pivotal phase 3 clinical trials, THRIVE and THRIVE-2, veligrotug met all of its primary and secondary endpoints. Veligrotug demonstrated a rapid onset of treatment effect and statistically significant and clinically meaningful reduction and resolution of diplopia in both clinical trials. THRIVE-2 was the first demonstration in a global phase 3 clinical trial of a statistically significant diplopia response and resolution in chronic TED patients. Veligrotug was generally well tolerated. Viridian believes that the differentiated Veligrotug has the potential to establish a strong position in the TED commercial market, if approved, and may help facilitate the introduction of VRDN-003, its potential best-in-class subcutaneous IGF-1R antibody for TED. About Viridian Therapeutics Viridian is a biopharmaceutical company focused on discovering, developing and commercializing potential best-in-class medicines for patients with serious and rare diseases. Viridian's expertise in antibody discovery and protein engineering enables the development of differentiated therapeutic candidates for previously validated drug targets in commercially established disease areas. Viridian is advancing multiple candidates in the clinic for the treatment of patients with thyroid eye disease (TED). The company is conducting a pivotal program for veligrotug (VRDN-001), including two global phase 3 clinical trials (THRIVE and THRIVE-2), to evaluate its efficacy and safety in patients with active and chronic TED. Both THRIVE and THRIVE-2 reported positive topline data, meeting all the primary and secondary endpoints of each study. Viridian is also advancing VRDN-003 as a potential best-in-class subcutaneous therapy for the treatment of TED, including two ongoing global phase 3 pivotal clinical trials, REVEAL-1 and REVEAL-2, to evaluate the efficacy and safety of VRDN-003 in patients with active and chronic TED. In addition to its TED portfolio, Viridian is advancing a novel portfolio of neonatal Fc receptor (FcRn) inhibitors, including VRDN-006 and VRDN-008, which has the potential to be developed in multiple autoimmune diseases. Viridian is based in Waltham, Massachusetts. For more information, please visit Follow Viridian on LinkedIn and X. Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of words such as, but not limited to, 'anticipate,' 'believe,' 'become,' 'continue,' 'could,' 'design,' 'estimate,' 'expect,' 'intend,' 'may,' 'might,' 'on track,' 'plan,' 'potential,' 'predict,' 'project,' 'should,' 'target,' 'will,' or 'would' or other similar terms or expressions that concern our expectations, plans and intentions. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations, and assumptions. Forward-looking statements include, without limitation, statements regarding: clinical development and anticipated commercialization of Viridian's product candidates, including veligrotug (formerly VRDN-001) and VRDN-003; the impact of Breakthrough Therapy Designation, including eligibility for Priority Review, or any other FDA designations; regulatory interactions and anticipated timing of regulatory submissions, including the anticipated BLA submission for veligrotug in the second half of 2025; the potential utility, efficacy, potency, safety, clinical benefits, clinical response, convenience, and number of indications of veligrotug and VRDN-003; veligrotug's potential to be a differentiated, IV treatment-of-choice for active and chronic TED or an important potential new treatment option; potential market sizes and market opportunities, including for Viridian's product candidates; Viridian's product candidates potentially being best-in-class; whether veligrotug will serve an unmet need; whether veligrotug may offer substantial improvement over existing therapies; and Viridian's expectations regarding the potential commercialization of veligrotug and VRDN-003, if approved, including the potential U.S. launch of veligrotug in 2026. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to: potential utility, efficacy, potency, safety, clinical benefits, clinical response, and convenience of Viridian's product candidates; that results or data from completed or ongoing clinical trials may not be representative of the results of ongoing or future clinical trials; that preliminary data may not be representative of final data; expectations and changes regarding the timing for regulatory filings; regulatory interactions; uncertainty and potential delays related to clinical drug development; the timing of and our ability to obtain and maintain regulatory approvals for our therapeutic candidates; competition from other therapies or products; estimates of market size; our future operating results and financial performance; Viridian's intellectual property position; that our product candidates may not be commercially successful, if approved; and other risks described from time to time in the 'Risk Factors' section of our filings with the Securities and Exchange Commission (SEC), including those described in our most recent Annual Report on Form 10-K or Quarterly Report on Form 10-Q, as applicable, and supplemented from time to time by our Current Reports on Form 8-K. Any forward-looking statement speaks only as of the date on which it was made. Neither the company, nor its affiliates, advisors, or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing the company's views as of any date subsequent to the date hereof. Source: Viridian Therapeutics, Inc.
Associated Press
04-03-2025
- Business
- Associated Press
Lirum Therapeutics Presents Positive Data on LX-101 at the 2025 ESMO Targeted Anticancer Therapies Congress; Highlighting LX-101's Promise in IGF-1R Prominent Cancers
New York, NY, March 04, 2025 (GLOBE NEWSWIRE) -- Lirum Therapeutics, Inc. ('Lirum'), an innovative clinical-stage biopharmaceutical company focused on the treatment of debilitating diseases, announced today the presentation of additional positive data on LX-101 at the 2025 ESMO Targeted Anticancer Therapies Congress (TAT) in Paris, France. LX-101, a novel clinical-stage payload-bearing targeted therapy directed to the insulin-like growth factor 1 receptor (IGF-1R), was selected for two presentations at this year's TAT conference. The first presentation, co-authored with investigators from the MD Anderson Cancer Center, showcases LX-101's strong in vivo activity in Ewing sarcoma as well as its potency in in vitro models of both Ewing sarcoma and desmoplastic small round cell tumor (DSRCT). These cancers have strong ties to IGF-1R, including DNA-level gene fusions that affect this signaling pathway. The second presentation highlights LX-101's broad potency against a host of IGF-1R-expressing cell lines from a number of additional adult cancers including lung, esophageal and stomach cancers, which represent large market opportunities. These presentations underscore LX-101's potent activity and promise in both pediatric and adult cancers with well-established ties to the IGF-1R pathway. The presentations are entitled: LX-101, a Novel, Clinical Stage, Payload-Bearing Targeted Therapy Directed to the Insulin-Like Growth Factor Receptor (IGF-1R), Demonstrates Potent Anti-Tumor Activity in Ewing Sarcoma Animal Models and Desmoplastic Small Round Cell Tumors. LX-101, a Novel, Clinical Stage, Payload-Bearing Targeted Therapy Directed to the Insulin-Like Growth Factor Receptor (IGF-1R), Demonstrates Potent Preclinical Anti-Tumor Activity Against Multiple Cancer Types with Elevated IGF-1R Expression. Both presentations are available on the Lirum website ( under the Investors and Media tab. Given these promising results, new clinical trials with LX-101 are planned in pediatric indications that carry strong ties to the IGF-1/IGF-1R pathway, including Ewing Sarcoma, DSRCT, rhabdomyosarcoma, and GIST. In addition, Lirum is planning trials in adult patients with cancer types that are naturally enriched for IGF-1R, including certain head and neck indications and others. In parallel, Lirum is also focused on developing LX-101 in thyroid eye disease (TED), where IGF-1R has been clinically and commercially validated. About Lirum Therapeutics, Inc. Lirum is an innovative clinical-stage biopharmaceutical company focused on the treatment of debilitating diseases through the acquisition, development and commercialization of novel drug candidates with compelling mechanisms of action, regulatory pathways and commercial opportunities. Lirum's lead candidate, LX-101, is a novel clinical-stage targeted therapy directed to the insulin-like growth factor 1 receptor (IGF-1R) with a differentiated mechanism of action. Lirum is developing LX-101 in oncology and autoimmune indications, including thyroid eye disease (TED). For more information on Lirum, please visit Forward Looking Statements This press release contains certain 'forward-looking statements' within the meaning of the 'safe harbor' provisions of the US Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: 'target,' 'believe,' 'expect,' 'will,' 'may,' 'anticipate,' 'estimate,' 'would,' 'positioned,' 'future,' and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on Lirum's current beliefs, expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Actual results and outcomes may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause actual results and outcomes to differ materially from those indicated in the forward-looking statements include, among others, the following: (1) the ability of Lirum to successfully develop its product candidates, including obtaining positive results from planned clinical trials, 2) expectations for the clinical development, manufacturing, regulatory approval and commercialization of our product candidates or other products we may acquire or in-license(3) expectations for incurring capital expenditures and generating revenue, 4) estimates of the sufficiency of our existing cash and cash equivalents and investments to finance operations, 5) changes in applicable laws or regulations; (6) the possibility that Lirum may be adversely affected by other economic, business, and/or competitive factors; (7) the impact of health epidemics, including the COVID-19 pandemic, on Lirum's business and the actions Lirum may take in response thereto; and (8) other risks and uncertainties indicated from time to time. There may be additional risks that Lirum considers immaterial or which are unknown. Any forward-looking statement made by us in this press release is based only on information currently available to Lirum and speaks only as of the date on which it is made. Lirum undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, except as required by law. Also, the information found on our website is not incorporated by reference into this press release and is included for reference purposes only. Company contact: Matt Hoberman Lirum Therapeutics, Inc. 1270 Ave of the Americas, 7th Floor New York, NY 10020
Yahoo
04-03-2025
- Business
- Yahoo
Lirum Therapeutics Presents Positive Data on LX-101 at the 2025 ESMO Targeted Anticancer Therapies Congress; Highlighting LX-101's Promise in IGF-1R Prominent Cancers
New York, NY, March 04, 2025 (GLOBE NEWSWIRE) -- Lirum Therapeutics, Inc. ('Lirum'), an innovative clinical-stage biopharmaceutical company focused on the treatment of debilitating diseases, announced today the presentation of additional positive data on LX-101 at the 2025 ESMO Targeted Anticancer Therapies Congress (TAT) in Paris, France. LX-101, a novel clinical-stage payload-bearing targeted therapy directed to the insulin-like growth factor 1 receptor (IGF-1R), was selected for two presentations at this year's TAT conference. The first presentation, co-authored with investigators from the MD Anderson Cancer Center, showcases LX-101's strong in vivo activity in Ewing sarcoma as well as its potency in in vitro models of both Ewing sarcoma and desmoplastic small round cell tumor (DSRCT). These cancers have strong ties to IGF-1R, including DNA-level gene fusions that affect this signaling pathway. The second presentation highlights LX-101's broad potency against a host of IGF-1R-expressing cell lines from a number of additional adult cancers including lung, esophageal and stomach cancers, which represent large market opportunities. These presentations underscore LX-101's potent activity and promise in both pediatric and adult cancers with well-established ties to the IGF-1R pathway. The presentations are entitled: LX-101, a Novel, Clinical Stage, Payload-Bearing Targeted Therapy Directed to the Insulin-Like Growth Factor Receptor (IGF-1R), Demonstrates Potent Anti-Tumor Activity in Ewing Sarcoma Animal Models and Desmoplastic Small Round Cell Tumors. LX-101, a Novel, Clinical Stage, Payload-Bearing Targeted Therapy Directed to the Insulin-Like Growth Factor Receptor (IGF-1R), Demonstrates Potent Preclinical Anti-Tumor Activity Against Multiple Cancer Types with Elevated IGF-1R Expression. Both presentations are available on the Lirum website ( under the Investors and Media tab. Given these promising results, new clinical trials with LX-101 are planned in pediatric indications that carry strong ties to the IGF-1/IGF-1R pathway, including Ewing Sarcoma, DSRCT, rhabdomyosarcoma, and GIST. In addition, Lirum is planning trials in adult patients with cancer types that are naturally enriched for IGF-1R, including certain head and neck indications and others. In parallel, Lirum is also focused on developing LX-101 in thyroid eye disease (TED), where IGF-1R has been clinically and commercially validated. About Lirum Therapeutics, is an innovative clinical-stage biopharmaceutical company focused on the treatment of debilitating diseases through the acquisition, development and commercialization of novel drug candidates with compelling mechanisms of action, regulatory pathways and commercial opportunities. Lirum's lead candidate, LX-101, is a novel clinical-stage targeted therapy directed to the insulin-like growth factor 1 receptor (IGF-1R) with a differentiated mechanism of action. Lirum is developing LX-101 in oncology and autoimmune indications, including thyroid eye disease (TED). For more information on Lirum, please visit Forward Looking StatementsThis press release contains certain 'forward-looking statements' within the meaning of the 'safe harbor' provisions of the US Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: 'target,' 'believe,' 'expect,' 'will,' 'may,' 'anticipate,' 'estimate,' 'would,' 'positioned,' 'future,' and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on Lirum's current beliefs, expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Actual results and outcomes may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause actual results and outcomes to differ materially from those indicated in the forward-looking statements include, among others, the following: (1) the ability of Lirum to successfully develop its product candidates, including obtaining positive results from planned clinical trials, 2) expectations for the clinical development, manufacturing, regulatory approval and commercialization of our product candidates or other products we may acquire or in-license(3) expectations for incurring capital expenditures and generating revenue, 4) estimates of the sufficiency of our existing cash and cash equivalents and investments to finance operations, 5) changes in applicable laws or regulations; (6) the possibility that Lirum may be adversely affected by other economic, business, and/or competitive factors; (7) the impact of health epidemics, including the COVID-19 pandemic, on Lirum's business and the actions Lirum may take in response thereto; and (8) other risks and uncertainties indicated from time to time. There may be additional risks that Lirum considers immaterial or which are unknown. Any forward-looking statement made by us in this press release is based only on information currently available to Lirum and speaks only as of the date on which it is made. Lirum undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, except as required by law. Also, the information found on our website is not incorporated by reference into this press release and is included for reference purposes only. Company contact: Matt HobermanInvestor RelationsIR@ Phone: (646) 389-6015 Lirum Therapeutics, Inc.1270 Ave of the Americas, 7th FloorNew York, NY 10020 Sign in to access your portfolio
Associated Press
04-03-2025
- Business
- Associated Press
ACELYRIN Determines Unsolicited Indication of Interest From Concentra Biosciences Not Reasonably Expected to Result in a Superior Proposal to Planned Alumis Merger
All-Stock Transaction with Alumis Maximizes Long-Term Value for ACELYRIN Stockholders LOS ANGELES, March 04, 2025 (GLOBE NEWSWIRE) -- ACELYRIN, INC. (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today announced that, after due consideration in consultation with its independent financial and legal advisors, its Board of Directors determined that the unsolicited indication of interest from Concentra Biosciences, LLC, of which Tang Capital Partners, LP is the controlling shareholder, is not reasonably expected to result in a superior proposal to the planned merger with Alumis Inc. (Nasdaq: ALMS). The ACELYRIN Board of Directors is confident that the all-stock transaction with Alumis maximizes long-term value for ACELYRIN stockholders and continues to recommend that stockholders support the planned merger. The transaction is expected to close in the second quarter of 2025, subject to approval by the stockholders of both companies and satisfaction of other customary closing conditions. ACELYRIN stockholders do not need to take any action at this time. Guggenheim Securities, LLC is serving as financial advisor to ACELYRIN and Fenwick & West LLP and Paul Hastings LLP are serving as its legal counsel. About ACELYRIN ACELYRIN, INC. (Nasdaq: SLRN) is focused on providing patients life-changing new treatment options by identifying, acquiring, and accelerating the development and commercialization of transformative medicines. ACELYRIN's lead program, lonigutamab, is a subcutaneously delivered monoclonal antibody targeting IGF-1R being investigated for the treatment of thyroid eye disease. Forward-Looking Statements This communication 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 ACELYRIN, Inc. ('ACELYRIN') in light of historical results and trends, current conditions and potential future developments, and are subject to various risks and uncertainties that could cause actual results to differ materially from such statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Words such as 'anticipate,' 'expect,' 'project,' 'intend,' 'believe,' 'may,' 'will,' 'should,' 'plan,' 'could,' 'continue,' 'target,' 'contemplate,' 'estimate,' 'forecast,' 'guidance,' 'predict,' 'possible,' 'potential,' 'pursue,' 'likely,' and words and terms of similar substance used in connection with any discussion of future plans, actions or events identify forward-looking statements. All statements, other than statements of historical facts, including express or implied statements regarding the proposed transaction (the 'proposed transaction') with Alumis Inc. ('Alumis'); the expected timing of the closing of the proposed transaction; the ability of ACELYRIN and Alumis to complete the proposed transaction considering the various closing conditions; and any assumptions underlying any of the foregoing, are forward-looking statements. Risks and uncertainties include, among other things, (i) the risk that the proposed transaction may not be completed in a timely basis or at all, which may adversely affect Alumis' and ACELYRIN's businesses and the price of their respective securities; (ii) the potential failure to receive, on a timely basis or otherwise, the required approvals of the proposed transaction, including stockholder approvals by both Alumis' stockholders and ACELYRIN's stockholders, and the potential failure to satisfy the other conditions to the consummation of the transaction; (iii) the effect of the announcement, pendency or completion of the proposed transaction on each of Alumis' or ACELYRIN's ability to attract, motivate, retain and hire key personnel and maintain relationships with partners, suppliers and others with whom Alumis or ACELYRIN does business, or on Alumis' or ACELYRIN's operating results and business generally; (iv) that the proposed transaction may divert management's attention from each of Alumis' and ACELYRIN's ongoing business operations; (v) the risk of any legal proceedings related to the proposed transaction or otherwise, or the impact of the proposed transaction thereupon, including resulting expense or delay; (vi) that Alumis or ACELYRIN may be adversely affected by other economic, business and/or competitive factors; (vii) the occurrence of any event, change or other circumstance that could give rise to the termination of the merger agreement, including in circumstances which would require Alumis or ACELYRIN to pay a termination fee; (viii) the risk that restrictions during the pendency of the proposed transaction may impact Alumis' or ACELYRIN's ability to pursue certain business opportunities or strategic transactions; (ix) the risk that the anticipated benefits and synergies of the proposed transaction may not be fully realized or may take longer to realize than expected; (x) the impact of legislative, regulatory, economic, competitive and technological changes; (xi) risks relating to the value of Alumis securities to be issued in the proposed transaction; (xii) the risk that integration of the proposed transaction post-closing may not occur as anticipated or the combined company may not be able to achieve the growth prospects expected from the transaction; (xiii) the effect of the announcement, pendency or completion of the proposed transaction on the market price of the common stock of each of Alumis and ACELYRIN; (xiv) the implementation of each of Alumis' and ACELYRIN's business model and strategic plans for product candidates and pipeline, and challenges inherent in developing, commercializing, manufacturing, launching, marketing and selling potential existing and new products and product candidates; (xv) the scope, progress, results and costs of developing Alumis' and ACELYRIN's product candidates and any future product candidates, including conducting preclinical studies and clinical trials, and otherwise related to the research and development of Alumis' and ACELYRIN's pipeline; (xvi) the timing and costs involved in obtaining and maintaining regulatory approval for Alumis' and ACELYRIN's current or future product candidates, and any related restrictions, limitations and/or warnings in the label of any approved product; (xvii) the market for, adoption (including rate and degree of market acceptance) and pricing and reimbursement of Alumis' and ACELYRIN's product candidates, if approved, and their respective abilities to compete with therapies and procedures that are rapidly growing and evolving; (xviii) uncertainties in contractual relationships, including collaborations, partnerships, licensing or other arrangements and the performance of third-party suppliers and manufacturers; (xix) the ability of each of Alumis and ACELYRIN to establish and maintain intellectual property protection for products or avoid or defend claims of infringement; (xx) Alumis' ability to successfully integrate ACELYRIN's operations and personnel; and (xxi) potential delays in initiating, enrolling or completing preclinical studies and clinical trials. These risks, as well as other risks related to the proposed transaction, will be described in the registration statement and the joint proxy statement/prospectus that will be filed with the SEC in connection with the proposed transaction. While the list of factors presented here and the list of factors to be presented in the registration statement are considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. For additional information about other factors that could cause actual results to differ materially from those described in the forward-looking statements, please refer to Alumis' and ACELYRIN's respective periodic reports and other filings with the SEC, including the risk factors identified in Alumis' and ACELYRIN's most recent Quarterly Reports on Form 10-Q and/or Annual Reports on Form 10-K. The risks and uncertainties described above and in the SEC filings cited above are not exclusive and further information concerning Alumis and ACELYRIN and their respective businesses, including factors that potentially could materially affect their respective businesses, financial conditions or operating results, may emerge from time to time. Readers are urged to consider these factors carefully in evaluating these forward-looking statements, and not to place undue reliance on any forward-looking statements, which speak only as of the date hereof. Readers should also carefully review the risk factors described in other documents Alumis and ACELYRIN file from time to time with the SEC. The forward-looking statements included in this communication are made only as of the date hereof. ACELYRIN assumes no obligation and does not intend to update these forward-looking statements, even if new information becomes available in the future, except as required by law. Additional Information and Where to Find It In connection with the proposed transaction, Alumis intends to file with the SEC the registration statement, which will include the joint proxy statement/prospectus. After the registration statement has been declared effective by the SEC, the joint proxy statement/prospectus will be delivered to stockholders of Alumis and ACELYRIN. BEFORE MAKING ANY VOTING OR INVESTMENT DECISION, SECURITY HOLDERS OF ALUMIS AND ACELYRIN ARE URGED TO READ THE JOINT PROXY STATEMENT/PROSPECTUS (INCLUDING ALL AMENDMENTS AND SUPPLEMENTS THERETO) AND OTHER DOCUMENTS RELATING TO THE MERGER THAT WILL BE FILED WITH THE SEC WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION. Investors and security holders will be able to obtain copies of the joint proxy statement/prospectus (when available) and other documents filed by Alumis and ACELYRIN with the SEC, without charge, through the website maintained by the SEC at Copies of the documents filed with the SEC by Alumis will be available free of charge under the SEC Filings heading of the Investor Relations section of Alumis' website at Copies of the documents filed with the SEC by ACELYRIN will be available free of charge under the Financials & Filings heading of the Investor Relations section of ACELYRIN's website at Participants in the Solicitation Alumis and ACELYRIN and their respective directors and executive officers may be deemed to be participants in the solicitation of proxies in respect of the proposed transaction. Information about Alumis' directors and executive officers is set forth in Alumis' registration statement on Form S-1/A (File No. 333-280068), which was filed with the SEC on June 24, 2024. Information about ACELYRIN's directors and executive officers is set forth in the proxy statement for ACELYRIN's 2024 Annual Meeting of Stockholders, which was filed with the SEC on April 22, 2024, and ACELYRIN's Current Reports on Form 8-K filed with the SEC on May 28, 2024, August 13, 2024 and December 10, 2024. Stockholders may obtain additional information regarding the interests of such participants by reading the registration statement and the joint proxy statement/prospectus and other relevant materials to be filed with the SEC regarding the proposed transaction when they become available. Investors should read the joint proxy statement/prospectus carefully when it becomes available before making any voting or investment decisions. No Offer or Solicitation This communication shall not constitute an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote or approval, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended. Contacts
