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ALX Oncology Presents Positive Updated Data from ASPEN-06 Phase 2 Trial Demonstrating Evorpacept Generates Strong Response and Durable Clinical Benefit in Patients with HER2-Positive Gastric Cancer
GlobeNewswire News Room· 2025-01-23 13:00
Core Message - ALX Oncology announced positive updated data from the ASPEN-06 Phase 2 clinical trial for evorpacept, a CD47-blocker, showing durable clinical response and a well-tolerated safety profile in HER2-positive advanced gastric cancer (GC) or gastroesophageal junction (GEJ) cancer patients [1] - The updated results were presented at the 2025 ASCO Gastrointestinal Cancers Symposium, highlighting evorpacept as the first CD47 blocker to show substantial tumor response in a prospective randomized trial [5] Clinical Trial Results - The ASPEN-06 trial demonstrated an overall response rate (ORR) of 41.3% in the intent-to-treat (ITT) population for evorpacept plus TRP (ETRP), compared to 30% for RP historical control and 26.6% for TRP control [6] - In patients with fresh HER2-positive biopsies, ETRP showed an ORR of 59.1%, compared to 30% for RP historical control and 23.1% for TRP control [6] - Median duration of response (mDOR) was 15.7 months for ETRP in the ITT population, compared to 9.1 months for TRP control [6] - Median progression-free survival (mPFS) was 7.5 months for ETRP in the ITT population, compared to 7.4 months for TRP control [6] - In patients with confirmed HER2-positive expression, ETRP resulted in a 48.9% ORR, mDOR of 15.7 months, and mPFS of 7.5 months, compared to 24.5% ORR, mDOR of 9.1 months, and mPFS of 6.7 months in the TRP control group [7] Safety Profile - Evorpacept plus TRP was generally well tolerated, with adverse events consistent with those in the TRP control group [7] Regulatory Status - The FDA has granted Fast Track designation to evorpacept for the second-line treatment of HER2-positive gastric or GEJ carcinoma [9] - Both the FDA and European Commission have granted Orphan Drug Designation for this indication [9] Company Overview - ALX Oncology is a clinical-stage biotechnology company focused on developing therapies that boost the immune system to treat cancer [11] - Evorpacept, the company's lead therapeutic candidate, is being evaluated in multiple ongoing clinical trials across various cancer indications [11] Presentation and Webcast - The updated ASPEN-06 data were presented at the 2025 ASCO Gastrointestinal Cancers Symposium [5] - ALX Oncology hosted a conference call and webcast on January 23, 2025, to review the updated data [10]
ALX Oncology Reports Inducement Grant as permitted by the Nasdaq Listing Rules
GlobeNewswire News Room· 2025-01-22 21:01
Company Announcement - ALX Oncology granted an inducement stock option to purchase 600,000 shares of common stock to Harish Shantharam, the Chief Financial Officer, effective January 21, 2025 [1] - The stock option has an exercise price of $1.65 per share, equal to the closing price on the grant date [2] - The option vests as follows: 25% on the one-year anniversary of January 21, 2025, and an additional 1/48th monthly thereafter, contingent on continued employment [2] Company Overview - ALX Oncology is a clinical-stage biotechnology company focused on developing therapies that enhance the immune system to treat cancer and extend patient lives [3] - The company's lead therapeutic candidate, evorpacept, is being evaluated in multiple ongoing clinical trials across various cancer indications [3] - Evorpacept has shown potential to serve as a cornerstone therapy in immuno-oncology [3]
Alexander's Announces Fourth Quarter Earnings Release Date and Vornado Realty Trust Quarterly Conference Call
Newsfilter· 2025-01-22 17:49
Company Announcements - Alexander's Inc will file its annual report on Form 10-K for the year ended December 31 2024 and issue its fourth quarter and full year earnings release on February 10 2025 before the New York Stock Exchange opens [1] - Vornado Realty Trust the manager of Alexander's operations will host a quarterly earnings conference call and audio webcast on February 11 2025 at 10:00 a m Eastern Time where information concerning Alexander's may be discussed [2] - The conference call can be accessed via phone or live webcast on Vornado's website with an online playback available after the call [3] Company Overview - Alexander's Inc is a real estate investment trust with five properties in New York City [3] Forward-Looking Statements - The company's forward-looking statements are subject to numerous assumptions risks and uncertainties including the impact of interest rates inflation and economic conditions on its business financial condition and operations [3]
Alexander's Announces Fourth Quarter Earnings Release Date and Vornado Realty Trust Quarterly Conference Call
GlobeNewswire News Room· 2025-01-22 17:49
Company Announcements - Alexander's Inc will file its annual report on Form 10-K for the year ended December 31 2024 and issue its fourth quarter and full year earnings release on February 10 2025 before the New York Stock Exchange opens [1] - Vornado Realty Trust the manager of Alexander's operations will host a quarterly earnings conference call and audio webcast on February 11 2025 at 10:00 am Eastern Time where information concerning Alexander's may be discussed [2] - The conference call can be accessed via phone or live webcast on Vornado's website with an online playback available after the call [3] Company Overview - Alexander's Inc is a real estate investment trust with five properties in New York City [3] Forward-Looking Statements - The company's forward-looking statements are subject to numerous assumptions risks and uncertainties including the impact of increased interest rates and inflation on its business financial condition results of operations cash flows and operating performance as well as the effect on its tenants and the broader real estate market [3]
ALX Resources Corp. Receives Shareholder Approval for the Previously Announced Plan of Arrangement with Greenridge Exploration Inc.
Newsfile· 2024-12-02 21:05
Arrangement Approval and Shareholder Vote - ALX Resources Corp received shareholder approval for the previously announced plan of arrangement with Greenridge Exploration Inc, with 85.08% of shareholders voting in favor [2][3] - The arrangement involves Greenridge acquiring all outstanding common shares of ALX through a court-approved plan under the Business Corporations Act (British Columbia) [3] - The arrangement resolution required approval from 66⅔% of votes cast by shareholders, which was surpassed with 85.08% approval [3] - All matters put before shareholders at the meeting, including the arrangement resolution, were approved [3] Voting Results - The number of directors was approved with 87.90% of votes in favor [4] - The election of directors was approved with 87.41% of votes in favor [4] - The appointment of auditors was approved with 87.19% of votes in favor [4] - The approval of the stock option plan was approved with 86.79% of votes in favor [4] - The approval of the arrangement was approved with 85.08% of votes in favor [4] Arrangement Details - Under the arrangement agreement, each ALX shareholder will receive 0.045 common shares of Greenridge for each ALX common share held [10] - Upon completion of the arrangement, existing Greenridge and ALX shareholders will own approximately 75.2% and 24.8% respectively of the combined entity, which will retain the name Greenridge [10] - The arrangement is expected to close on or about December 13, 2024, subject to regulatory and court approvals [8] Company Overview - ALX Resources Corp is based in Vancouver, BC, Canada, and its common shares are listed on the TSXV, Frankfurt Stock Exchange, and the US OTC market [11] - The company explores a portfolio of prospective mineral properties in Canada, including uranium, lithium, nickel, copper, and gold projects [12] - ALX holds interests in over 240,000 hectares of prospective lands in Saskatchewan, a stable jurisdiction with high-grade uranium mines and other mineral resources [12] Mineral Projects - ALX has 100% interests in several uranium projects in northern Saskatchewan, including Gibbons Creek, Sabre, Bradley, Javelin, and McKenzie Lake [13] - The company also owns 100% interests in the Firebird Nickel Project, Flying Vee Nickel/Gold, and Sceptre Gold projects, and can earn up to an 80% interest in the Alligator Lake Gold Project [14] - ALX owns or can earn up to 100% interests in the Electra Nickel Project and the Cannon Copper Project in Ontario, and the Vixen Gold Project, which is under option to First Mining Gold Corp [15] - The company holds a 50% interest in the Hydra Lithium Project in Quebec and 100% interests in the Anchor, Crystal, and Reindeer Lithium Projects in Nova Scotia and Saskatchewan [16]
ALX Oncology Appoints Alan Sandler, M.D., as Chief Medical Officer
GlobeNewswire News Room· 2024-11-14 13:00
Company Leadership - ALX Oncology appoints Dr Alan Sandler as Chief Medical Officer, leveraging his extensive experience in oncology and drug development to advance the company's clinical programs [1] - Dr Sandler's expertise spans clinical development, regulatory affairs, drug safety, and development strategies, with prior leadership roles at Mirati Therapeutics, Zai Lab, and Genentech [2] - As a former member of ALX Oncology's Board of Directors, Dr Sandler has firsthand knowledge of the company's leadership team and the clinical potential of its lead compound evorpacept [3] Clinical Development - ALX Oncology's lead therapeutic candidate evorpacept is positioned as a cornerstone therapy for the future of immuno-oncology, with ongoing clinical trials across multiple cancer indications [4] - Dr Sandler aims to advance evorpacept into late-stage clinical trials, with the goal of improving patient outcomes across a wide range of tumor types and treatment settings [2][3] Industry Expertise - Dr Sandler brings over 300 co-authored publications, including peer-reviewed articles, reviews, abstracts, and book chapters, reflecting his deep academic and clinical contributions to oncology [3] - His previous roles at Mirati Therapeutics, Zai Lab, and Genentech highlight his leadership in oncology drug development and regulatory strategy, aligning with ALX Oncology's mission to innovate cancer therapies [2]
Alexander's Is A Good Business That The Market Has Overestimated
Seeking Alpha· 2024-11-12 11:00
Author Background - The author is an economics graduate with a strong interest in financial history and applies this knowledge to analyze market trends and identify value [1] Disclosure and Compensation - The author has no stock, option, or derivative positions in any mentioned companies and no plans to initiate such positions within the next 72 hours [2] - The author is not receiving compensation for the article except from Seeking Alpha [2] - The author has no business relationship with any company whose stock is mentioned in the article [2] Seeking Alpha's Disclaimer - Seeking Alpha emphasizes that past performance does not guarantee future results and does not provide investment recommendations or advice [3] - The views expressed in the article may not reflect those of Seeking Alpha as a whole [3] - Seeking Alpha is not a licensed securities dealer, broker, or US investment adviser or investment bank [3] - The analysts contributing to Seeking Alpha include both professional and individual investors who may not be licensed or certified by any institute or regulatory body [3]
ALX Oncology Reports Third Quarter 2024 Financial Results and Provides Corporate Update
GlobeNewswire News Room· 2024-11-07 21:00
Clinical Progress and Developments - The company reported significant clinical progress in Q3 2024, particularly with the topline data from the ASPEN-06 Phase 2 trial, where evorpacept demonstrated durable clinical benefits and a well-tolerated safety profile in HER2-positive gastric/GEJ cancer patients [2][3] - Evorpacept achieved a confirmed overall response rate (ORR) of 40.3% compared to 26.6% in the control arm, with a median duration of response of 15.7 months versus 7.6 months in the intent-to-treat population (N=127) [3] - In a pre-specified population with fresh HER2-positive biopsies (n=48), the Evo-TRP combination showed an ORR of 54.8% compared to 23.1% in the control arm [3] - The company initiated patient dosing in September 2024 for a Sanofi-partnered study evaluating evorpacept in combination with SARCLISA and dexamethasone for relapsed or refractory multiple myeloma (RRMM) [3] - The leadership team was strengthened with the appointment of Dr. Alan Sandler to the Board of Directors, bringing over 30 years of oncology and drug development experience [3] Upcoming Clinical Milestones - Breast cancer: Phase 1b/2 trial results for evorpacept combined with zanidatamab in HER2-positive and HER2-low metastatic breast cancer will be presented at the San Antonio Breast Cancer Symposium on December 12, 2024 [4] - Gastric/GEJ cancer: Updated results from the ASPEN-06 Phase 2 trial are expected in the first half of 2025, with a Phase 3 registrational trial initiation planned for mid-2025 [4] - Head and neck squamous cell carcinoma: Topline results from Phase 2 trials (ASPEN-03 and ASPEN-04) with KEYTRUDA are anticipated in the first half of 2025 [4] - Urothelial cancer: Updated results from a Phase 1 trial of ASPEN-07 in combination with PADCEV are expected in the first half of 2025 [4] - Breast cancer: Topline results from a Phase 1b I-SPY TRIAL with ENHERTU are expected in the second half of 2025 [4] Financial Performance - Cash, cash equivalents, and investments totaled $162.6 million as of September 30, 2024, sufficient to fund operations into Q1 2026 [5] - Research and development (R&D) expenses decreased by $19.3 million to $26.5 million in Q3 2024, primarily due to reduced clinical and development costs [5] - General and administrative (G&A) expenses decreased by $1.4 million to $6.1 million in Q3 2024, driven by lower stock-based compensation and accounting consulting costs [5] - GAAP net loss for Q3 2024 was $30.7 million, or ($0.58) per share, compared to a net loss of $51.0 million, or ($1.24) per share, in Q3 2023 [5] - Non-GAAP net loss for Q3 2024 was $23.7 million, compared to $44.0 million in Q3 2023 [5] Corporate Overview - ALX Oncology is a clinical-stage biotechnology company focused on developing therapies that enhance the immune system to treat cancer [6] - The company's lead candidate, evorpacept, is being evaluated across multiple clinical trials for various cancer indications, with potential as a cornerstone therapy in immuno-oncology [6]
Alexander's (ALX) Tops Q3 FFO and Revenue Estimates
ZACKS· 2024-11-04 15:55
Earnings Performance - Alexander's reported quarterly FFO of $2.84 per share, beating the Zacks Consensus Estimate of $2.57 per share, representing a 10.51% surprise [1] - This compares to FFO of $3.63 per share a year ago [1] - The company has surpassed consensus FFO estimates two times over the last four quarters [2] Revenue Performance - Alexander's posted revenues of $55.68 million for the quarter ended September 2024, surpassing the Zacks Consensus Estimate by 4.07% [2] - This compares to year-ago revenues of $55.41 million [2] - The company has topped consensus revenue estimates three times over the last four quarters [2] Stock Performance - Alexander's shares have added about 5.9% since the beginning of the year, underperforming the S&P 500's gain of 20.1% [3] Future Outlook - The current consensus FFO estimate is $2.79 on $53.5 million in revenues for the coming quarter and $13.65 on $221.9 million in revenues for the current fiscal year [7] - The estimate revisions trend for Alexander's is mixed, translating into a Zacks Rank 3 (Hold) [6] Industry Context - The REIT and Equity Trust - Other industry is currently in the top 27% of the 250 plus Zacks industries [8] - The top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1 [8] Peer Comparison - DiamondRock Hospitality (DRH) is expected to post quarterly earnings of $0.26 per share, representing no change from the year-ago quarter [9] - DiamondRock Hospitality's revenues are expected to be $286.98 million, up 3.8% from the year-ago quarter [10]
Alexander's Announces Third Quarter Financial Results
GlobeNewswire News Room· 2024-11-04 14:16
PARAMUS, N.J., Nov. 04, 2024 (GLOBE NEWSWIRE) -- ALEXANDER’S, INC. (New York Stock Exchange: ALX) filed its Form 10-Q for the quarter ended September 30, 2024 today and reported: Third Quarter 2024 Financial Results Net income for the quarter ended September 30, 2024 was $6.7 million, or $1.30 per diluted share, compared to $10.8 million, or $2.10 per diluted share for the quarter ended September 30, 2023. Funds from operations (“FFO”) (non-GAAP) for the quarter ended September 30, 2024 was $14.6 million, o ...